Drinking Water Regulation and Health

DRINKING WATER REGULATION AND HEALTH

FREDERICK W. PONTIUS, P.E. Pontius Water Consultants, Inc., Lakewood, Colorado

A JOHN WILEY & SONS, INC. PUBLICATION

DRINKING WATER REGULATION AND HEALTH

DRINKING WATER REGULATION AND HEALTH

FREDERICK W. PONTIUS, P.E. Pontius Water Consultants, Inc., Lakewood, Colorado

A JOHN WILEY & SONS, INC. PUBLICATION

The reader should not rely on this publication to address specific questions that apply to a particular set of facts. The authors and publisher make no representation or warranty, express or implied, as to the completeness, correctness or utility of the information in this publication. In addition, the authors and publisher assume no liability of any kind whatsoever resulting from the use of or reliance upon the contents of this book.

1 This book is printed on acid-free paper.


Copyright # 2003 by John Wiley & Sons, Inc. All rights reserved. Published simultaneously in Canada. No part of this publication may be reproduced, stored in a retrieval system or transmitted in any form or by any means, electronic, mechanical, photocopying, recording, scanning or otherwise, except as permitted under Sections 107 or 108 of the 1976 United States Copyright Act, without either the prior written permission of the Publisher, or authorization through payment of the appropriate per-copy fee to the Copyright Clearance Center, 222 Rosewood Drive, Danvers, MA 01923, (978) 750-8400, fax (978) 750-4744. Requests to the Publisher for permission should be addressed to the Permissions Department, John Wiley & Sons, Inc., 605 Third Avenue, New York, NY 10158-0012, (212) 850-6011, fax (212) 850-6008, E-Mail: [email protected]. For ordering and customer service information please call 1-800-CALL-WILEY. Library of Congress Cataloging-in-Publication Data: Pontius, Frederick W. Drinking water regulation and health = Frederick W. Pontius. p. cm. Includes bibliographical references and index. ISBN 0-471-41554-5 (cloth) 1. Drinking water—Law and legislation—United States. 2. United States. Safe Drinking Water Act, I. Title. KF3794.P658 2003 346.73040 69122–dc21 2003006645 Printed in the United States of America. 10 9 8 7 6 5 4 3 2 1

CONTENTS PREFACE ACKNOWLEDGMENTS CONTRIBUTORS ACRONYMS

PART I

1

THE SAFE DRINKING WATER ACT AND PUBLIC HEALTH

Drinking Water and Public Health Protection

xix xxi xxiii xxvii

1 3

Daniel A. Okun

1.1 1.2 1.3 1.4 1.5 1.6 1.7 1.8 1.9 1.10 1.11

2

Introduction, 3 Water Supply for the City of Rome, 4 The Middle Ages and the Industrial Revolution, 5 The Great Sanitary Awakening, 6 The Emergence of Water as a Public Health Issue, 9 The Beginning of Water Treatment, 11 The Chemical Revolution, 13 The Introduction of Regulations, 14 Prelude to the 1974 Safe Drinking Water Act, 17 Drinking Water in Developing Countries, 19 The Future of Public Water Supply, 21

Improving Waterborne Disease Surveillance

25

Floyd J. Frost, Rebecca L. Calderon and Gunther F. Craun

2.1 2.2 2.3 2.4 2.5 2.6 2.7 2.8

Introduction, 25 Background, 26 Limitations of the Current Disease Surveillance Systems, 28 Early Detection of Outbreaks, 31 Endemic Disease, 32 Applicability of Outbreak Investigations, 34 Monitoring Infection Versus Disease, 36 Improving Disease Surveillance, 38 v

vi

3

CONTENTS

Waterborne Outbreaks in the United States, 1971–2000

45

Gunther F. Craun, Rebecca L. Calderon, and Michael F. Craun

3.1 3.2 3.3

3.4

3.5

3.6

4

Introduction, 45 Waterborne Disease Outbreak Surveillance System, 46 Waterborne Outbreak Statistics, 48 3.3.1 Type of Water System, 48 3.3.2 Type of Water Source, 51 3.3.3 Outbreak Etiologies, 53 3.3.4 Severity of Illness, 55 Causes of Outbreaks in Drinking Water Systems, 55 3.4.1 Etiology of Drinking Water Outbreaks, 55 3.4.2 Water System Deficiencies, 58 3.4.3 Water Quality During Outbreaks, 59 Outbreaks Associated with Recreational Waters, 61 3.5.1 Lakes, 61 3.5.2 Pools, 61 3.5.3 Recreational Outbreaks Reported Since 1991, 63 Outbreak Trends, 65

History of the Safe Drinking Water Act (SDWA) Frederick W. Pontius

4.1 4.2 4.3

4.4 4.5 4.6

4.7 4.8

Introduction, 71 Early Development of Drinking Water Standards, 72 The Safe Drinking Water Act of 1974, 73 4.3.1 The National Interim Primary Drinking Water Regulations, 75 4.3.2 National Academy of Sciences (NAS) Study, 77 4.3.3 1977–1980 SDWA Amendments, 77 1986 SDWA Amendments, 79 1988 Lead Contamination Control Act, 80 1996 SDWA Amendments, 81 4.6.1 Reauthorization Issues Emerge, 81 4.6.2 GAO Studies Note Deficiencies, 82 4.6.3 102nd Congress, 83 4.6.4 103rd Congress, 84 4.6.5 USEPA Redirection of Regulatory Priorities, 88 4.6.6 104th Congress Activity, 90 Public Health Security and Bioterrorism Preparedness and Response Act, 91 Future Outlook, 95

71

CONTENTS

5

SDWA: Looking to the Future

vii

105

Diane VanDe Hei and Thomas Schaeffer

5.1 5.2

5.3

5.4

5.5

5.6

PART II 6

Introduction, 105 U.S. Governmental Structure, 105 5.2.1 The Executive Branch, 106 5.2.2 The Legislative Branch, 106 5.2.3 The Judicial Branch, 106 How Laws Are Made, 107 5.3.1 How Legislation Originates, 107 5.3.2 The Committee–Subcommittee Process, 108 5.3.3 Floor Action on Bills, 109 5.3.4 The Conference Committee Process, 109 5.3.5 Final Passage, Approval, and Publication, 110 5.3.6 Authorization and Appropriation Measures, 110 Forces Shaping the SDWA and Amendments, 111 5.4.1 The Setting for the 1974 SDWA, 111 5.4.2 The Setting for the 1986 Amendments, 114 5.4.3 The Setting for the 1996 Amendments, 116 5.4.4 The Setting for the 2002 Amendments, 121 Future Amendments to the SDWA, 121 5.5.1 Political Dimension, 121 5.5.2 Social Dimension, 122 5.5.3 Scientific Dimension, 123 5.5.4 Unresolved Issues, 124 5.5.5 Emerging Issues, 125 Outlook for Major Change, 127

REGULATION DEVELOPMENT

Toxicological Basis for Drinking Water Risk Assessment Joyce Morrissey Donohue and Jennifer Orme-Zavaleta

6.1 6.2

6.3

6.4 6.5

Introduction, 133 Toxicological Evaluation of Drinking Water Contaminants, 133 6.2.1 Human Studies, 136 6.2.2 Animal Studies, 137 Use of Toxicity Information in Risk Assessment, 137 6.3.1 Cancer Risk Guidelines, 138 6.3.2 Effects Other than Cancer, 139 6.3.3 Maximum Contaminant Level Goal (MCLG), 141 Health Advisories, 143 Future Outlook, 145

131 133

viii

7

CONTENTS

Epidemiologic Concepts for Interpreting Findings in Studies of Drinking Water Exposures

147

Gunther F. Craun, Rebecca L. Calderon and Floyd J. Frost

7.1 7.2 7.3 7.4 7.5 7.6

7.7

7.8 8

Introduction, 147 What Is Epidemiology?, 149 Historical Origins, 149 Disease Models, 150 Basic Measures of Disease Frequency, 152 Types of Epidemiologic Studies, 156 7.6.1 Ecological Studies, 158 7.6.2 Time-Series Analyses, 161 7.6.3 Random and Systematic Error, 162 7.6.4 Measures of Association, 167 7.6.5 Strength of Association, 168 7.6.6 Causality of an Association, 168 7.6.7 Meta analysis, 169 Examples: Experimental, Cohort, and Case–Control Studies, 170 7.7.1 Experimental Studies, 170 7.7.2 Cohort Studies, 172 7.7.3 Case–Control Studies, 174 Future Trends in Epidemiology and Drinking Water, 178

Application of Risk Assessments in Crafting Drinking Water Regulations

183

Bruce A. Macler

8.1 8.2 8.3 8.4

8.5 9

Introduction, 183 Risk Assessment Approaches for Drinking Water Regulations, 184 Risk Mandates from the Safe Drinking Water Act, 188 Developing MCLs and Treatment Techniques, 189 8.4.1 Maximum Contaminant Level Goals, 189 8.4.2 Identifying Candidate MCLs, 191 8.4.3 Health Risk Reduction and Cost Analysis, 193 8.4.4 Risk Assessments as Regulations, 193 8.4.5 Regulatory Reviews of NPDWRs, 194 Future Outlook, 195

‘‘Sound’’ Science and Drinking Water Regulation Frederick W. Pontius

9.1 9.2

Introduction, 197 Elements of ‘‘Sound’’ Science, 198 9.2.1 Objectivity, 199 9.2.2 Reason and Truth Claims, 199

197

CONTENTS

9.3 9.4 9.5 9.6 9.7 9.8

9.9 10

9.2.3 Clarity, 204 9.2.4 Critical Thinking, 205 Peer Involvement, 206 Scientific Disagreement, 209 ‘‘Junk’’ Science, 210 Causation and Causal Inference, 211 Science and SDWA Regulations, 214 Science and the Courts, 215 9.8.1 Judicial Review, 215 9.8.2 The Judicial Review Process, 216 9.8.3 Deference, 218 9.8.4 Example: Chloroform MCLG, 219 Future Developments and Trends, 221

Benefit–Cost Analysis and Drinking Water Regulation Robert S. Raucher

10.1 10.2 10.3 10.4 10.5

ix

Introduction, 225 Benefit–Cost Analysis (BCA) Under the SDWA, 226 Historical Application of BCA, 227 USEPA Policies and Practices, 228 Comparing Benefits to Costs, 229 10.5.1 Maximizing Net Benefits, 229 10.5.2 Incremental Benefits and Costs, 230 10.5.3 Accounting for System Size, 231 10.6 Measures of Risk Reduction Benefits, 233 10.6.1 Quantifying Risk Reduction Benefits, 233 10.6.2 Quality-Adjusted Life Years, 234 10.6.3 Valuing Risk Reduction Benefits, 235 10.6.4 Willingness to Pay: The Value of a Statistical Life, 236 10.6.5 Cost of Illness, 237 10.7 Benefits Transfer to Drinking Water, 238 10.7.1 Adjusting VSL, 239 10.7.2 Accounting for Latencies, 239 10.7.3 Discounting Costs and Benefits, 240 10.7.4 Adjusted VSLs to Reflect Latency, Discounting, and Income Growth, 241 10.8 Uncertainty and Variability, 242 10.8.1 What are Uncertainty and Variability?, 242 10.8.2 Addressing Uncertainties and Variabilities, 243 10.9 Precautionary Assumptions versus Central Tendencies, 244 10.10 Omitted or Unquantified Benefits and Costs, 246 10.11 Uncertain Costs, 247 10.12 Future Outlook, 247

225

x

11

CONTENTS

Public Involvement in Regulation Development

251

Frederick W. Pontius

11.1 11.2 11.3 11.4

11.5

11.6 11.7 11.8 11.9 PART III 12

Introduction, 251 Who is the Public?, 251 Objectives Determine Involvement Level, 252 Involvement during the Rulemaking Process, 253 11.4.1 Involvement Prior to Rule Proposal, 258 11.4.2 Involvement during Rule Proposal, 259 11.4.3 Involvement after Rule Proposal, 259 11.4.4 Ex Parte Communications, 260 Federal Agency Advisory Committees, 261 11.5.1 National Drinking Water Advisory Council (NDWAC), 264 11.5.2 USEPA Science Advisory Board, 265 Regulatory Negotiation, 266 Judicial Review, 268 USEPA’s Public Involvement Policy, 269 The Future of Public Participation, 271 CONTAMINANT REGULATION AND TREATMENT

Control of Drinking Water Pathogens and Disinfection Byproducts Stig E. Regli, Paul S. Berger and Thomas R. Grubbs

12.1 12.2 12.3

Introduction, 277 Control of Waterborne Pathogens Before the 1970s, 277 Control of Waterborne Pathogens and DBPs in the 1970s, 280 12.3.1 Total Coliform Rule (TCR), 281 12.3.2 Turbidity and Heterotrophic Bacteria, 282 12.3.3 Trihalomethanes (THMs), 283 12.4 Control of Waterborne Pathogens and DBPs in the 1980s, 284 12.4.1 Revised Total Coliform Rule, 285 12.4.2 Surface Water Treatment Rule (SWTR), 286 12.5 Control of Waterborne Pathogens and DBPs in the 1990s and Beyond, 289 12.5.1 1996 SDWA Amendments for Pathogen and DBP Control, 292 12.5.2 Information Collection Rule (ICR), 293 12.5.3 Stage 1 Disinfection Byproducts Rule (DBPR), 294 12.5.4 Strengthening the SWTR: The IESWTR, LT1ESWTR, and Filter Backwash Recycling Rule, 296 12.5.5 Ground Water Rule, 299 12.5.6 LT2ESWTR and Stage 2 DBPR, 300 12.6 A View Toward the Future, 301

275

277

xi

CONTENTS

13

Regulating Radionuclides in Drinking Water

307

David R. Huber

13.1 13.2 13.3

13.4 13.5 13.6 13.7

13.8

14

Introduction, 307 Radiation Basics, 310 SDWA Requirements for Radionuclide Standards, 312 13.3.1 Linear No-Threshold Assumption, 313 13.3.2 NonCancer Effects, 313 1976 Radionuclide Regulations, 314 1991 Proposed Radionuclides Rule, 317 1996 SDWA Amendments and Rule Revisions, 318 2000 Final Radionuclides Rule, 322 13.7.1 Alpha Emitters, 323 13.7.2 Radium 226=228, 323 13.7.3 Radium 224, 328 13.7.4 Uranium, 329 13.7.5 Beta and Photon Emitters, 332 Future Outlook, 336

Risk-Based Framework for Future Regulatory Decision-Making

339

Mark Gibson and Mike Osinsiki

14.1 14.2 14.3

14.4

14.5 14.6

14.7

Introduction, 339 SDWA Amendments of 1996, 340 Role of Third-Party Consultations in Regulatory Development, 342 14.3.1 The National Research Council (NRC), 342 14.3.2 The National Drinking Water Advisory Council (NDWAC), 343 Role of USEPA Programs, 344 14.4.1 National Drinking Water Contaminant Occurrence Database (NCOD), 344 14.4.2 Unregulated Contaminant Monitoring Program, 345 14.4.3 Drinking Water Research Plan, 346 Development of the First CCL, 347 Public Health Decisions from the 1998 CCL, 349 14.6.1 Applicability of Prioritization Schemes for CCL Contaminants, 351 14.6.2 Generalized Decisionmaking Framework, 351 14.6.3 NDWAC Regulatory Decisionmaking Protocols, 354 14.6.4 Regulatory Decisions from the 1998 CCL, 355 Development of Future CCLs, 356 14.7.1 Identifying Future Drinking Water Contaminants, 356 14.7.2 Classifying Future Contaminants for Regulation Consideration, 358

xii

CONTENTS

14.7.3 Overview of Classification Strategies, 363 14.7.4 PCCL to CCL: Attributes of Contaminants, 367 14.8 Illustration of a Prototype Classification Scheme, 368 14.8.1 The Training Data Set, 368 14.8.2 Attribute Scoring, 369 14.8.3 Prototype Classification Functions, 369 14.8.4 Classification Results Using a Linear Classifier, 372 14.8.5 Classification Results Using a Neural Network Classifier, 373 14.8.6 Examination of Misclassified Contaminants, 373 14.8.7 Validation Test Cases, 374 14.8.8 Prediction for Interesting Test Cases, 374 14.9 Virulence Factor–Activity Relationships (VFARs), 375 14.10 NRC Recommendations and Future Directions, 376 15

Selection of Treatment Technology for SDWA Compliance

381

Frederick W. Pontius

15.1 15.2

15.3 15.4

15.5 15.6 15.7 16

Introduction, 381 SDWA Requirements Affecting Technology Selection, 381 15.2.1 Best Available Technology (BAT), 382 15.2.2 Compliance and Variance Technologies, 383 15.2.3 Compliance Technology Lists, 384 15.2.4 Variance Technology Determinations, 384 Acceptance of New Technology, 385 Advanced Treatment Technology Overview, 386 15.4.1 Membranes, 387 15.4.2 Ultraviolet (UV) Disinfection, 390 15.4.3 Advanced Oxidation, 391 15.4.4 Ion-Exchange and Inorganic Adsorptive Media, 393 15.4.5 Biological Filtration, 394 Simultaneous Compliance, 395 Process Optimization, 396 Technology Selection, 396

SDWA Compliance Using Point-of-Use (POU) and Point-of-Entry (POE) Treatment Frederick W. Pontius, Regu P. Regunathan and Joseph F. Harrison

16.1 16.2 16.3 16.4 16.5 16.6

Introduction, 403 POU and POE Technology Benefits, 404 POU and POE Technology Limitations, 405 SDWA Requirements for POU and POE Technology, 407 Certification Programs, 408 POU and POE Technology Overview, 411

403

CONTENTS

xiii

16.6.1 16.6.2 16.6.3 16.6.4 16.6.5

POU Carbon Units, 411 POU Reverse-Osmosis Devices, 412 POU UV Devices, 414 POU Distillers, 414 POU Activated Alumina (AA) and Adsorptive Media Units, 415 16.6.6 Other POU Products, 415 16.6.7 POE Products, 415 16.7 Selecting POU and POE Technologies, 417 16.7.1 Pilot Testing, 418 16.7.2 Certification, 419 16.7.3 State and Local Regulations, 419 16.7.4 Negotiating Initial Costs, 420 16.7.5 Operation and Maintenance, 420 16.7.6 Residuals and Waste Disposal, 420 16.8 Installation and Maintenance, 420 16.9 Monitoring, 422 16.10 Implementation Issues and Strategies, 422 16.10.1 Public Relations, 423 16.10.2 Administration, 423 16.10.3 Operator Training and Certification, 424 16.10.4 Liability, 424 16.10.5 Equipment Reliability, 425 16.10.6 Waste Disposal, 425 16.10.7 Economics and Cost Estimating, 426 16.11 Future Outlook and Trends, 427

PART IV 17

COMPLIANCE CHALLENGES

Death of the Silent Service: Meeting Consumer Expectations Elisa M. Speranza

17.1 17.2 17.3 17.4 17.5

Introduction, 433 Who Are Water Utility Customers?, 433 Public Water Suppliers as a Monopoly, 436 Where Customers Obtain Information, 436 What Customers Think and Want, 437 17.5.1 Trust and Consumer Confidence, 438 17.5.2 Customer Satisfaction Surveys, 439 17.6 Gaining Customer Support, 441 17.7 Communicating with Customers, 441 17.7.1 Communicating Risk, 442 17.7.2 Consumer Confidence Reports, 443

431 433

xiv

CONTENTS

17.7.3 Strategic Communications Planning, 444 17.7.4 Stakeholder Involvement, 445 17.8 Benefits of Customer Communication, 446 18

Achieving the Capacity to Comply

449

Peter E. Shanaghan and Jennifer Bielanski

18.1 18.2

Introduction, 449 Water System Capacity, 450 18.2.1 Technical Capacity, 451 18.2.2 Managerial Capacity, 451 18.2.3 Financial Capacity, 452 18.2.4 Interrelationships among Capacity Dimensions, 452 18.3 Assessing Water System Capacity, 452 18.4 Enhancing System Capacity, 455 18.5 Future Outlook, 461 19

Achieving Sustainable Water Systems Janice A. Beecher

19.1 19.2

19.3

19.4

19.5

19.6

Introduction, 463 Sustainable Systems, 464 19.2.1 Systems Perspectives, 465 19.2.2 Water Systems as Systems, 466 19.2.3 Sustainability and System Size, 467 Sustainability and the SDWA, 468 19.3.1 The SDWA and Capacity, 469 19.3.2 The SDWA and Affordability, 469 19.3.3 The SDWA and Conservation Planning, 472 19.3.4 Implications, 472 Affordability and Sustainability, 473 19.4.1 Ability versus Willingness to Pay, 473 19.4.2 Affordability Thresholds, 474 19.4.3 Utility Assistance Programs, 474 19.4.4 Rate Design and Affordability, 475 19.4.5 The Role of Subsidies, 476 Pricing Theory, 477 19.5.1 Efficiency, 477 19.5.2 Prices, Income, and Demand, 478 19.5.3 Equity, 479 19.5.4 Sustainable Price Characteristics, 481 Rate Design, 481 19.6.1 Principles of Rate Design, 482 19.6.2 Cost Allocation, 483

463

xv

CONTENTS

19.6.3 Rate Design Options, 484 19.6.4 Implementation Strategies, 486 19.7 Future Trends in Achieving Sustainability, 487 20

Protecting Sensitive Subpopulations

491

Jeffrey K. Griffiths

20.1 20.2 20.3 20.4 20.5

Introduction, 491 Defining Sensitive Subpopulations, 491 Sensitive Subpopulations and the SDWA, 492 Identifying Sensitive Subpopulations, 493 What Makes a Person or Population Sensitive?, 495 20.5.1 Cancer or Adverse Reproductive Consequences, 495 20.5.2 Infections, 497 20.5.3 People with AIDS, 498 20.5.4 Transplantation, 500 20.5.5 Chemotherapy, 501 20.5.6 Immunosuppressive Therapy, 501 20.5.7 Diabetes, 502 20.5.8 Sensitivity to Exposure, 503 20.5.9 Genetic Predisposition, 504 20.6 Which Sensitive Subpopulations Are of Concern to Water Providers?, 505 20.7 Can or Should a Water Supplier Identify Who Belongs to a Sensitive Subpopulation?, 506 20.8 Nontransient and Transient Noncommunity Systems, 506 20.9 Public Health Concepts Relevant to Sensitive Subpopulations, 507 20.9.1 Reducing or Eliminating Exposure, 507 20.9.2 Acting on Suspicion, 508 20.9.3 Defining Increased Risk, 508 20.9.4 How Significant Is Increased Risk?, 508 20.9.5 Defining an Adverse Event or Outcome, 508 20.10 Future Outlook, 509 21

Environmental Justice and Drinking Water Regulation Frederick W. Pontius

21.1 21.2

Introduction, 513 Environmental Justice as a Movement, 513 21.2.1 National Environmental Justice Advisory Council, 516 21.2.2 Executive Order 12898, 516 21.3 Identifying Environmental Justice Situations, 517 21.3.1 Environmental Justice Communities, 517 21.3.2 Key Factors, 519

513

xvi

CONTENTS

21.3.3 Economic Tradeoffs, 519 21.3.4 Intergenerational Equity, 521 21.3.5 Quantitative Methods, 525 21.3.6 Scientific and Policy Limitations, 525 21.4 Environmental Justice and Contaminant Regulation, 526 21.5 Implications for Water Utilities, 528 21.6 Future Outlook, 529 22

What Water Suppliers Need to Know about Toxic Tort Litigation

533

Kenneth A. Rubin

22.1 22.2 22.3

Introduction, 533 Basics of Toxic Torts, 534 What Plaintiffs Must Prove, 538 22.3.1 Does the Water Contain a Contaminant, and Has the Plaintiff Been Exposed to It?, 538 22.3.2 Is the Level of the Contaminant Sufficient to Cause Harm?, 538 22.3.3 Has that Contaminant Caused the Injury?, 538 22.4 Key Steps in Litigation, 543 22.4.1 In the Beginning, 543 22.4.2 Threshold Requirements for a Class Action, 544 22.4.3 Discovery, 547 22.4.4 Trial, 548 22.5 Case Histories Involving Water Suppliers, 549 22.5.1 Sovereign Immunity, 549 22.5.2 Failure to Give Municipality Mandatory Advance Notice, 550 22.5.3 Federal, State, and PUC Preemption, 550 22.5.4 Consumer Confidence Reports and Litigation, 551 22.5.5 Court Action Regarding Treatment of Water, 552 22.6 Future Outlook for Tort Litigation, 552 23

Intellectual Property Laws and Water Technology Linda E. B. Hansen

23.1 23.2 23.3

Introduction, 555 Property, Copyrights, Trademarks, and Patents, 555 Patent Laws, 556 23.3.1 Historical Overview of Patent Protection, 557 23.3.2 The United States Patent System, 558 23.3.3 Basic Requirements for Patentability, 558 23.4 Obtaining a Patent, 563 23.5 Patent Infringement, 564 23.6 Future Outlook in Intellectual Property Law, 566

555

CONTENTS

24

Water System Security

xvii

567

Frederick W. Pontius

24.1 24.2 24.3

Introduction, 567 Threats to Public Water Systems, 568 SDWA Security Provisions, 570 24.3.1 Emergency Powers, 571 24.3.2 Tampering, 571 24.3.3 Vulnerability Assessments, 572 24.3.4 Emergency Response Plan, 573 24.3.5 Reviews and Information Sharing, 575 24.4 Department of Homeland Security, 576 24.4.1 DHS Organization, 576 24.4.2 Critical Infrastructure, 578 24.4.3 Homeland Security Advisory System, 579 24.5 Future Outlook, 580

APPENDIXES A

Summary Tables of Drinking Water Standards and Health Advisories

583

USEPA Office of Ground Water and Drinking Water and USEPA Office of Science and Technology

B C

1962 U.S. Public Health Service Standards

621

Section-by-Section Summary of the SDWA

635

Frederick W. Pontius

D

Text of the SDWA as Amended and Related Statutes

721

Compiled by Frederick W. Pontius

E

How Our Laws are Made

871

Charles W. Johnson

F

Enactment of a Law

923

Robert B. Dove

G

Listing of Drinking Water Federal Register Notices Compiled by Frederick W. Pontius, P.E.

953

xviii

H

CONTENTS

Outline of 40 CFR 141, 142, and 143

971

Compiled by Frederick W. Pontius

I

Example Capacity Development Tool

979

South Dakota Department of Environment and Natural Resources

J

U.S. Water Industry Statistics

995

USEPA Office of Ground Water and Drinking Water

INDEX

1009

PREFACE

Drinking water engineers and scientists generally receive extensive academic training in math, science, engineering, and technical subjects needed to pursue their chosen profession. In most cases, little formal training (and even then only a lecture or two) is provided on legislative and regulatory procedure and current issues prior to entering the workforce. By and large young (and old) professionals are essentially spoon fed, expected to accept what they are told by whatever a particular industry or lobbying group, professor or instructor, or agency they prefer or are compelled to believe. Few are able to take the time to understand and consider the issues discussed in this volume and draw thoughtful conclusions on their own, and if they do, many do not know where to begin. Such was the case for me as a young engineer. In the early 1980s, I attended my first meeting of the American Water Works Association (AWWA) Water Quality Division. There, Trustee Alan A. Stevens, then a USEPA research scientist (now retired), announced that a new drinking water regulation had just been issued, and then proceeded to hold up a copy of the Federal Register notice. What’s that? I asked. A few years later, at a national conference I sensed the excitement of many (and the disappointment of others) over the enactment of amendments to the Safe Drinking Water Act (SDWA) the day before. But lobbyists only knew the content of the new law, except for those who knew exactly where to look. [The Internet would not come into common use until well over a decade later.] The water industry’s need for a common sense understanding of regulatory and legislative procedure and issues was demonstrated to me in a series of events in the early 1990s. A paper I had written, ‘‘Complying with the New Drinking Water Quality Regulations,’’ was published in the February 1990 issue of Journal of the American Water Works Association, and won the 1990 AWWA Publications Award. Soon thereafter, Nancy Zeilig, then editor of the Journal AWWA, agreed to publish on a trial basis a monthly column on legislative and regulatory issues, known as Leg=Reg. The first article appeared in July 1990, ‘‘Surface Water Treatment Regulations.’’ In addition, I began preparing an annual review article on drinking water regulations, also published in the Journal AWWA. These articles became very popular after only a short period of time (several won Best Paper Awards), and they soon took on a life of their own. The Leg=Reg column was published monthly for xix

xx

PREFACE

over 10 years. With the support of Marcia Lacey, current editor of the Journal AWWA, the annual reviews are still published (as of 2003), although the nature of such reviews has changed each year given the flood of regulatory and legislative information now available on the Internet. Since the mid-1990s, use of the Internet has grown tremendously, especially within the water industry. Legislative and regulatory information is now more widely available than ever before. Unfortunately, this has resulted in a different problem— information overload. It is easy now to find information on regulatory and legislative matters. But it can be more difficult now to follow and understand the thinking, developmental work, and politics behind them. Indeed, federal and state regulators, as well as water utilities and consultants, spend most of their time and effort just keeping up with what requirements they must meet, let alone having time to fully understand the technical and policy basis behind them. This particular volume was developed to fill the current need for a professional reference text for water utilities, consultants, and regulators, regarding the regulation of drinking water in the United States. Basic principles are presented concerning the SDWA and drinking water regulation. It is not intended to be a detailed compliance guide to every regulation—nor does it cover the blow-by-blow of current political lobbying activities. Chapter authors for this first edition were intentionally selected from a cross-section of different agencies and organizations. In preparing their chapter, the author(s) worked independently to present the state of the knowledge in their subject area. Each chapter was peer reviewed prior to publication. By focusing only on certain foundational issues, this volume will hopefully provide for many the understanding they need to more effectively participate in the legislative and regulatory process, better determine what regulatory actions and activities are relevant to their water utility or agency, and thereby make better legislative and regulatory compliance decisions. Supplemented with additional reading and problem sets, this volume is also appropriate as a text for classroom use, either in undergraduate or graduate environmental engineering programs. By understanding the history and basic principles associated with drinking water legislation and regulation, and confronting current issues early in their career, students will be better prepared as they enter the workforce. In particular, professionals in the field who will spend at least some portion (and in some cases all) of their career working for a regulatory agency will benefit the most from early exposure to legislative and regulatory procedures and issues. Since enactment of the SDWA in 1974, great progress has been made in drinking water quality and regulation in the United States. It seems now that only the most difficult issues remain—protecting sensitive populations, achieving sustainable water systems, providing affordable drinking water for small systems, avoiding risk–risk tradeoffs, and controlling emerging waterborne pathogens, to name only a few. The need for creative thinking and innovation in drinking water regulation and legislation has never been greater. To that end, this volume is dedicated. Frederick W. Pontius Lakewood, Colorado

ACKNOWLEDGMENTS

This book would not have come about except for the dedication and persistence of the authors whose work is included herein. I have had the privilege over the prior 20þ years to know and, in many cases, work with them in differing circumstances that has created for me rich learning opportunities. My deep appreciation is especially expressed to Daniel Okun, Gunther Craun, Diane VanDe Hei, Tom Schaefer, Joyce Donohue, Jennifer Orme Zavaletta, Bruce Macler, Bob Raucher, Stig Regli, Tom Grubbs, Paul Berger, David Huber, Mark Gibson, Mike Osinski, Elisa Speranza, Peter Shanaghan, Jeff Griffiths, and Ken Rubin. There are many others who have inspired and contributed to my career that should be mentioned, but space would not allow it, so I can name only a few. David Preston, Executive Director of the American Water Works Association (AWWA) from 1979 to 1985, was instrumental early in my career, starting me down the path at AWWA in 1982 despite being stricken by illness (I remained at AWWA until 1999). I will always remember the early encouragement Abel Wolman provided to me at my first national conference. Before his well-deserved retirement (first from USEPA, then from the University of Houston), Dr. Jim Symons was a constant source of encouragement and instruction to me through the peaks and valleys I have experienced thus far in my career. Jack Sullivan, AWWA Deputy Executive Director (now retired), hired me as part of the AWWA Government Affairs program in 1989, and provided me many early tutorials. Though my principal objective was to care for my cancer-stricken father, and be with him when he died (both of which I was able to accomplish over a 5-year period), I had many valuable experiences under Jack during my term of service in Washington, D.C. Appreciation is expressed to Al Warburton, AWWA Director of Legislative Affairs, and other members of the AWWA Washington Office staff, for their support and advice during those years. During my term of service to them, the members of the Water Utility Council, Technical Advisory Group, and various Technical Workgroups, helped to shape my understanding of regulatory and legislative issues, water industry positions, and the political ways of Washington, D.C. More recently, John Regnier and the National Rural Water Association (NRWA) have provided support for my continuing work on a variety of national regulatory policy issues. Several of the chapters in this volume were adapted by the authors xxi

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ACKNOWLEDGMENTS

from white papers they had prepared for NRWA. The support of NRWA is greatly acknowledged. Appreciation is expressed to the Office of Ground Water and Drinking Water of the U.S. Environmental Protection Agency (USEPA) for allowing this work to go forward and especially to the federal employees who took the time to contribute to this volume. Appreciation is also due to Bob Esposito, Executive Editor at John Wiley & Sons, Inc., for his patience and encouragement as the group labored to prepare their manuscripts, and to Christine Punzo, Associate Managing Editor at Wiley, for shepherding the manuscripts through review and production.

CONTRIBUTORS

Janice A. Beecher, Ph.D., Director, Institute of Public Utilities, Michigan State University, East Lansing, Michigan Jennifer Bielanski, Drinking Water Utilities Team, Office of Water, Office of Ground Water and Drinking Water, U.S. Environmental Protection Agency, Washington, DC Paul S. Berger, Ph.D., Microbiologist, Office of Water, Office of Ground Water and Drinking Water, U.S. Environmental Protection Agency, Washington, DC Rebecca L. Calderon, Ph.D., Office of Research and Development, National Health and Environmental, Effects Research Laboratory, U.S. Environmental Protection Agency, Research Triangle Park, North Carolina Gunther F. Craun, P.E., M.P.H., D.E.E., Gunther F. Craun and Associates, Staunton, Virginia Michael F. Craun, P.E., M.S., Gunther F. Craun and Associates, Staunton, Virginia Joyce Morrissey Donohue, Ph.D., Toxicologist, Office of Water, Office of Science and Technology, U.S. Environmental Protection Agency, Washington, DC Floyd J. Frost, Ph.D., Director, Epidemiology Program, Lovelace Respiratory Research Institute, The Lovelace Institutes, Albuquerque, New Mexico xxiii

xxiv

CONTRIBUTORS

Mark Gibson, Program Officer, National Research Council, Water Science and Technology Board, Washington, DC Jeffrey K. Griffiths, M.D., M.P.H., T.M., Director, Graduate Programs in Public Health, Tufts University School of Medicine, Boston, Massachusetts Thomas R. Grubbs, P.E., Environmental Engineer, Office of Water, Office of Ground Water and Drinking Water, U.S. Environmental Protection Agency, Washington, DC Linda E. B. Hansen, Esq., Attorney, Patterson, Thuente, Skaar, and Christensen, L.L.C., Milwaukee, Wisconsin Joseph F. Harrison, P.E., CWS-VI, Technical Director, Water Quality Association, Lisle, Illinois David R. Huber, Regulation Manager, Office of Water, Office of Ground Water and Drinking Water, U.S. Environmental Protection Agency, Washington, DC Bruce A. Macler, Ph.D., Toxicologist, U.S. Environmental Protection Agency, Region 9, San Francisco, California Daniel A. Okun, Ph.D., Kenan Professor of Environmental Engineering, Emeritus, Department of Environmental Science and Engineering, University of North Carolina, Chapel Hill, North Carolina Jennifer Orme-Zavaleta, Associate Director for Science, Office of Research and Development, National Health and Environmental Effects Research Laboratory, U.S. Environmental Protection Agency, Corvallis, Oregon Michael Osinski, Drinking Water Utilities Team Leader, Office of Ground Water and Drinking Water, U.S. Environmental Protection Agency, Washington, DC Frederick W. Pontius, P.E., Pontius Water Consultants, Inc., Lakewood, Colorado Robert Raucher, Ph.D., Executive Vice President, Stratus Consulting Inc., Boulder, Colorado Stig E. Regli, Environmental Engineer, Office of Water, Office of Ground Water and Drinking Water, U.S. Environmental Protection Agency, Washington, DC Regu P. Regunathan, Ph.D., ReguNathan & Associates, Inc., Wheaton, Illinois

CONTRIBUTORS

xxv

Kenneth A. Rubin, Esq., Partner, Tort, Environmental, and Construction Practice, Morgan Lewis and Bockius, L.L.P., Washington, DC Thomas Schaefer, Regulatory Specialist, Association of Metropolitan Water Agencies, Washington, DC Peter E. Shanaghan, Chief of Staff, Office of Water, Office of Ground Water and Drinking Water, U.S. Environmental Protection Agency, Washington, DC Elisa M. Speranza, Vice President, CH2M Hill, New Orleans, Louisiana Diane VanDe Hei, Executive Director, Association of Metropolitan Water Agencies, Washington, DC

ACRONYMS

AA AF AIDS AMCL ANSI ANPRM AOP APA AR ARPA ASDWA ATSDR AWWA AWWARF AX

Activated alumina Attributable fraction Acquired immune deficiency syndrome Alternative maximum contaminant level American National Standards Institute Advance Notice of Proposed Rulemaking Advanced oxidation process Administrative Procedure Act Attributable risk Advanced Research Projects Agency Association of State Drinking Water Administrators Agency for Toxic Substances Diseases Registry American Water Works Association AWWA Research Foundation Anion exchange

B–C BAT BCA BMD BOM BT BTWC

Benefit–cost ratio Best available technology Benefit–cost analysis Benchmark dose Biodegradable organic matter Benefits transfer Biological and Toxins Weapons Convention

CA CCC

Cellulose acetate Chlorine Chemistry Council xxvii

xxviii

ACRONYMS

CCE CCL CCR CDC CERCLA

DEP DFO DHS DNA DWC DWCCL DWEL DWPL DWSRF

Carbon chloroform extract Contaminant Candidate List Consumer Confidence Report Centers for Disease Control and Prevention Comprehensive Environmental Response, Compensation and Liability Act Confidence interval Cost of illness Comprehensive performance evaluation Disinfectant residual concentration (C ) in milligrams per liter (mg=L) multiplied by the disinfectant contact time (T ) in minutes Clean Water Act Chemical Warfare Convention Community water system Clean Water State Revolving Loan Fund Community Water Supply Study Design, build, and operate Disinfection byproduct Disinfection Byproducts Rule Department of Environment and Natural Resources (South Dakota) Department of the Environment Designated Federal Official Department of Health Services Deoxyribonucleic acid Drinking Water Committee Drinking Water Contaminant Candidate List Drinking water equivalent level Drinking Water Priority List Drinking Water State Revolving Loan Fund

EBCT EDE EDF EDR EEAC EJ ELI EO ETV

Empty-bed contact time Effective dose equivalent Environmental Defense Fund Electrodialysis reversal Environmental Economics Advisory Committee Environmental justice Environmental Law Institute (Washington, DC) Executive Order Environmental Technology Verification

FACA FAS FBRR FGR

Federal Advisory Committee Act Federation of American Scientists Filter Backwash Recycling Rule Federal Guidance Report

CI COI CPE CT

CWA CWC CWS CWSRF CWSS DBO DBP DBPR DENR

ACRONYMS

GAC GAO GFH gpd GPRA GRAS GSA GWR

Granular activated carbon General Accounting Office Granular ferric hydroxide Gallons per day Government Performance and Results Act Generally recognized as safe General Services Administration Ground Water Rule

HA HAA5 HACCP HIV HPC HRL HRRCA HUD

Health Advisory Sum of five haloacetic acids Hazard assessment critical control point Human immunodeficiency virus Heterotrophic plate count Health reference level Health risk reduction and cost analysis Housing and Urban Development

IBMTR IBWA ICR IESWTR IOC IOM IQ IRIS ISAC IX

International Bone Marrow Transplant Registry International Bottled Water Association Information Collection Rule Interim Enhanced Surface Water Treatment Rule Inorganic contaminant Institute of Medicine Intelligence quotient Integrated Risk Information System Information Sharing and Analysis Center Ion exchange

LCR LED10 LNT LOAEL LP-LI LP-MI LSLR LTESWTR LT1ESWTR LT2ESWTR LYS

Lead and Copper Rule Lower limit on effective dose (producing an adverse effect in 10% of subjects exposed to a chemical) Linear nonthreshold Lowest-observed-adverse-effect level Low-pressure, low-intensity Low-pressure, medium-intensity Lead service line replacement Long Term Enhanced Surface Water Treatment Rule Long Term 1 Enhanced Surface Water Treatment Rule Long Term 2 Enhanced Surface Water Treatment Rule Life years saved

MCL MCLG MEGO MF mgd

Maximum contaminant level Maximum contaminant level goal My eyes glaze over Microfiltration Million gallons per day

xxix

xxx

ACRONYMS

MIB MMM MOE MP-HI MRDL MWB MWRA

Methylisoborneol Multimedia mitigation Margin of exposure Medium-pressure, high-intensity Maximum residual disinfectant level Metropolitan Water Board Massachusetts Water Resources Authority

NAE NAPA NAS NCOD NCSL NCWS NDWAC NEETF NEJAC NF NGA NIMBY NIPC NIPDWR NIRS NOAEL NODA NOM NOMS NORS NPDES NPDWR NRA NRC NRDC NRWA NSF NTNCWS NTU NWIS NYC DEP

National Academy of Engineering National Academy of Public Administration National Academy of Sciences National Contaminant Occurrence Database National Conference of State Legislatures Noncommunity Water System National Drinking Water Advisory Council National Environmental Education and Training Foundation National Environmental Justice Advisory Council Nanofiltration National Governors Association Not in my backyard National Infrastructure Protection Center (of FBI) National interim primary drinking water regulation National Inorganics and Radionuclides Survey No-observed-adverse-effect level Notice of data availability Natural organic matter National Organics Monitoring Survey National Organics Reconnaissance Survey National Pollutant Discharge Elimination System National primary drinking water regulation Negotiated Rulemaking Act National Research Council Natural Resources Defense Council National Rural Water Association National Science Foundation Nontransient noncommunity water system Nephelometric Turbidity Units National Water Information System New York City Department of Environmental Protection

OGWDW O&M OMB OPCW OR

Office of Ground Water and Drinking Water Operation and maintenance Office of Management and Budget Organization for the Prohibition of Chemical Weapons Odds ratio

ACRONYMS

PAC PCCL PCU PDWR POD POE POTWs POU PTA PUV PWS PWSS

Powdered activated carbon; Political Action Committee Preliminary Contaminant Candidate List Pinellas County Utilities Primary Drinking Water Regulation Point of departure Point of entry Publicly owned treatment works Point of use Packed-tower aeration Pulsed ultraviolet Public water system Public water system supervision

QALY QSAR

Quality-adjusted life years Quantitative structure–activity relationship

RD R&D RfC RfD RIA RMCL RO RR RSC

Rate difference Research and development Inhalation reference concentration Reference dose Regulatory impact analysis Recommended maximum contaminant level Reverse osmosis Relative risk Relative source contribution

SAB SAC SAR SARA SBA SDWA SDWR SDWIS SEB SEER SOCs SPAM SRLF SWT SWTR

Science Advisory Board Strong-acid cationic (resin) Structure–activity relationships Superfund Amendments and Reauthorization Act Strong-base anionic (resin) Safe Drinking Water Act Secondary Drinking Water Regulation Safe Drinking Water Information System Staphylococcal enterotoxin B Surveillance, Epidemiology, and End Result Synthetic organic chemicals (also compounds) Safety, participation, affordability, and management State Revolving Loan Fund Source water treatment Surface Water Treatment Rule

TCLP TCR TDS TFC THMs

Toxicity characteristic leaching potential Total Coliform Rule Total dissolved solids Thin-film composite Trihalomethanes

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ACRONYMS

TNCWS TOC TON TRIP TRO TT TTHMs

Transient noncommunity water system Total organic carbon Threshold order number Trade-Related Aspects of Intellectual Property Temporary restraining order (for patentholders) Treatment technique Total trihalomethanes

UCC UCM UCMR UF UIC UL USC USCM USEPA USGS USPHS UV

Uniform Commercial Code Unregulated contaminant monitoring Unregulated Contaminant Monitoring Rule Ultrafiltration Underground injection control Underwriters Laboratory United States Code U.S. Conference of Mayors U.S. Environmental Protection Agency U.S. Geological Survey U.S. Public Health Service Ultraviolet

VA VFAR VOC VSL

Veterans Administration Virulence factor–activity relationship Volatile organic contaminant Value of a statistical life

WAC WBA WMD WQA WQR WTP

Weak-acid cationic (resin) Weak-base anionic (resin) Weapons of mass destruction Water Quality Association Water Quality Report Willingness to pay

PART I THE SAFE DRINKING WATER ACT AND PUBLIC HEALTH

Drinking Water Regulation and Health, Edited by Frederick W. Pontius. ISBN 0-471-41554-5 # 2003 John Wiley & Sons, Inc.

1 DRINKING WATER AND PUBLIC HEALTH PROTECTION DANIEL A. OKUN, Sc.D., P.E. Kenan Professor of Environmental Engineering, Emeritus, University of North Carolina Chapel Hill, North Carolina

1.1

INTRODUCTION

The provision of drinking water for communities is an urban utility, but a utility with a difference. As with other urban utilities, such as electricity and gas, water for household use is a necessity that cannot readily be obtained by urban householders for themselves. The difference is that, while water may satisfy many household needs, including drinking, it has the potential of spreading disease, often without the knowledge of the consumer. As a result, water supplies have become subject to regulations for assuring adequate quality, regulations that are not faced by other municipal public utilities. Beginning with the water supply for Rome some 2000 years ago, the responsibility for water supply and its quality rested with the community. During the nineteenth century, with the beginning of the industrial era and the rapid growth of cities, public water supplies began to be provided by private entrepreneurs who sought profit in providing an essential service, frequently in competition with others. In the interest of getting a larger share of the market, they might provide a water of better quality than a competitor. The experiences with the provision of water for London from the Thames in the 1850s illustrate that the selection of the source of a water supply is Drinking Water Regulation and Health, Edited by Frederick W. Pontius. ISBN 0-471-41554-5 # 2003 John Wiley & Sons, Inc.

3

4

DRINKING WATER AND PUBLIC HEALTH PROTECTION

important. Then Dr. John Snow took advantage of the competition between two water suppliers to prove that water was responsible for the transmission of cholera. As cities grew, the need for large capital investments to provide adequate water supplies of high quality resulted in most cities abandoning private utilities when it became clear that they did not have the financial resources for the construction of the reservoirs, the long transmission lines, and the treatment plants. Decisions for selection of sources and treatment, which were introduced in the late nineteenth–early twentieth century, became the responsibility of the community, and not a regulatory body. Treatment in the form of filtration and then chlorination was widely introduced, although not primarily through regulation. City officials recognized that they had an obligation to their constituencies to provide water that would not spread typhoid and cholera. Some cities were slow to assume this responsibility, and, in the United States, some newly organized state health agencies began to institute regulations. The choice of sources between a costly high-quality upland supply and a polluted source and the treatment to be provided was local. The first nationwide water quality regulations in the United States were introduced by the federal government in 1909 to assure the safety of water to which the public was exposed in interstate and international traffic. Many states adopted these regulations even for smaller cities that did not have train or bus service. These federal regulations were upgraded over the years, and the bulk of this chapter is devoted to the nature of these regulations at the federal level until the passage of the Safe Drinking Water Act (SDWA) in 1974, after the U.S. Environmental Protection Agency (USEPA) became responsible for ensuring the safety of all public water supplies. This chapter recounts the high points in the history of the role that urban water supplies play in the health of those who are obliged to drink from public supplies, beginning with concerns with the water supply for Rome, followed by the story of the cholera outbreaks in London that led to the recognition that water was responsible for the spread of infectious disease, the introduction of successful public health measures to control infectious disease, and the explosion of the chemical revolution that became responsible for the spread of chronic disease through ingestion of public water supplies (Okun 1996).

1.2

WATER SUPPLY FOR THE CITY OF ROME

Among the major ancient cities of the world, none was better provided with water for its citizens than Rome. Initially, the city obtained its water from the Tiber River, which ran through the city. When it was apparent that the water had become heavily polluted, Appius Claudius built an aqueduct, the Aqua Appia, in 312 B.C. from the Tiber, about 11 miles upstream. Some 40 years later, the need was so great that a second aqueduct, 40 miles long, the Anio Novis, was built. Sextus Julius Frontinus, the water commissioner of Rome, wrote two books describing the water works of the city and their management (Frontinus A.D. 97). By A.D. 305, 14 aqueducts were serving the city.

1.3 THE MIDDLE AGES AND THE INDUSTRIAL REVOLUTION

5

The aqueducts fed the city by gravity with relatively short sections passing over valleys on stone arches, some three tiers high. Many of them carried water into the twentieth century. Such aqueducts remain throughout Europe and the Middle East as monuments to the early Romans. The water from the aqueducts passed through large cisterns and from these was distributed through lead pipes to other cisterns, to public buildings, baths, and fountains, and to a relatively small number of private residences. Incidentally, they also built stone sewers to carry off wastewater from bathtubs and toilets in the larger buildings. Frontinus questioned the wisdom of Augustus, whom he considered a most cautious ruler, in building one of the aqueducts, the Alsietinian, because the quality of its water was very poor and not suitable for the people. He speculated that Augustus built the aqueduct to serve nonpotable purposes and thereby ‘‘to avoid drawing on better sources of supply.’’ The most important nonpotable use was for a naumachia, an artificial lake that was used for exhibitions of sham naval battles (Fig. 1.1). This is also current practice in American cities that erect stadia for baseball, football, and basketball on behalf of the team owners. The surplus nonpotable water was used for landscape irrigation and fountains. Words from an inscription state: ‘‘I gave the people the spectacle of a naval combat . . . . Besides the rowers, three thousand men fought in these fleets.’’ Thus, Rome can claim to be the first city to employ a dual distribution system and to base the use of its water supply on its quality. The water quality from the aqueducts was variable, and the Marcia aqueduct carried the best water. Frontinus points out that it was ‘‘determined to separate (the aqueducts) and then to arrange that the Marcia should serve wholly for drinking purposes, and that the others should be used for purposes adapted to their special qualities.’’ It is interesting to note that, in 1958, some 2000 years later, the United Nations Economic and Social Council enunciated a policy (United Nations 1958): ‘‘No higher quality water, unless there is a surplus of it, should be used for a purpose that can tolerate a lower grade.’’

1.3

THE MIDDLE AGES AND THE INDUSTRIAL REVOLUTION

Beginning in the sixth century, the Roman Empire began to disintegrate and, up to the fourteenth century, infectious diseases rode rampant throughout Europe. Leprosy, bubonic plague, smallpox, diphtheria, measles, influenza, and countless other afflictions were epidemic, particularly in the cities. Water was only one of the many vectors for the spread of disease. Knowledge of the specific vectors was limited, and food received the most attention. Quarantine was the principal approach to control of the spread of disease. The lack of proper sanitation and the dense urban populations were largely responsible for the epidemics and there was little focus on water quality and its availability. The major accomplishment toward the end of the Middle Ages was the establishment of hospitals, often for specific diseases, by local governments and workers’

6

DRINKING WATER AND PUBLIC HEALTH PROTECTION

Figure 1.1

Naumachia (from a coin of Domitian) (Frontinus

A.D.

97).

guilds. Little of importance with regard to the water environment and the public health emerged during that period.

1.4

THE GREAT SANITARY AWAKENING

In the middle of the nineteenth Century, the causes of the many common diseases of the day that afflicted the growing urban populations that accompanied the Industrial Revolution were still unknown. Water was beginning to be piped to houses of the well-to-do while the poor either carried their water from wells or bought water from purveyors who obtained the water at the most convenient sources. When the water was contaminated, which was its general condition in urban areas, the spread of disease was inevitable.

1.4 THE GREAT SANITARY AWAKENING

7

A more significant and serious situation resulted from the growing installation rate of piping and then water closets in homes and commercial establishments. In addition to the impact of a poor quality water for drinking was the necessity for disposing of the discharges of these new flush toilets. London had found it necessary to construct storm sewers to drain the streets to permit the conduct of commerce. The obvious solution was to discharge the household wastes from the toilets to the storm sewers, which, in turn, discharged directly into the Thames River, which ran through London and served as a source of water for several private companies that distributed the water to households. London was exemplary of the unsavory and squalid conditions in all cities in the early years of the century. The medical fraternity believed that the diseases were spread by poisons in the miasmatic air emanating from the ‘‘bowels of the earth.’’ The Thames at London at that time was a tidal river and the heavily polluted waters would flow very slowly to sea. In warm periods, Londoners avoided crossing London Bridge because the air was so foul. A headline of the period read ‘‘India is in Revolt and the Thames Stinks.’’ The drapery in the Houses of Parliament, located on bank of the Thames, needed to be soaked in chloride of lime to make the meeting room tolerable, and stirred the Parliament to establish the first of many committees to see to alleviating the situation. Two cholera outbreaks in the summer of 1854 were the greatest in London’s history. The first developed in Soho, a densely populated section in the heart of the city. Dr. John Snow, then physician to Queen Victoria Hospital, and reasonably the first epidemiologist, undertook to mark the deaths in the summer of 1953. In 2 days, 197 people died, and after 10 days more than 500 people died in an area only 250 yards across (Longmate 1966). Plotting the deaths on a map of the area (Fig. 1.2), the result resembled a target, with the greatest concentration of hits at the center. A church-owned well on Broad Street was identified at the site as being the source of the water ingested by the victims. The water had appeared to be of excellent quality. A woman living about a mile away regularly sent a cart to carry water to her home; she and a guest from outside London died of cholera in that epidemic. Dr. Snow examined the well site and concluded that a tannery on property owned by the church had a cesspool for discharge of its wastewaters. He ordered the church to remove the handle on the pump, ending the epidemic, but, by that time, the epidemic might well have been spent. At any rate, this demonstration was the first to suggest that drinking water was the source of the cholera. This was generations before the germ theory of disease had been elucidated, and Snow’s other studies in London were even more convincing. The John Snow Pub is on the site of the Broad Street pump, and these data decorate its walls. Annual death rates from cholera among households using Thames River water ranged from 10 to 110 per 10,000 households in 1832, increasing to 200 per 10,000 among those taking water from the downstream reaches of the river. While this justified the inference that water was responsible, Dr. Snow found a more definitive proof during the 1854 epidemic. Two private water companies, the Southwark and Vauxhall Company and the Lambeth Company were in direct competition, serving

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DRINKING WATER AND PUBLIC HEALTH PROTECTION

Figure 1.2 Map of Soho showing the location of those who died from cholera within the vicinity of the Broad Street pump in London 1854 (Cosgrove 1909).

piped water to the same area near the center of London but on the south side of the river. These water companies were characterized as ‘‘by far the worst of all those that take their water from the Thames, with 120 to 180 deaths per 10,000 households in 1849 for each of the two companies.’’ (Snow 1936) In 1852, however, the Lambeth Company, to attract more customers, improved the aesthetic quality of the Thames River water by moving its intake upstream above the heaviest pollution from London. Snow’s data showed that, in the 1854 epidemic, the death rate among those using Lambeth water was 37 deaths per 10,000 households as compared with 315 per 10,000 households for those using the intake downstream. During that period, the death rate in all of London was 59 per 10,000 households (256,423 deaths) among those taking water from all sources in London. In addition to establishing that the cholera outbreaks were caused by drinking water, Snow demonstrated the importance of source selection. As is pointed out below, almost a century later, some cities still chose to take water from run-of-river sources when better sources were available primarily because it was less costly. Professor Fair, in presenting his philosophy about water supply, characterized the

1.5 THE EMERGENCE OF WATER AS A PUBLIC HEALTH ISSUE

9

issue by declaring that he ‘‘preferred the virginal to the repentant,’’ a paraphrase of the philosophy of Allen Hazen, possibly the most important engineer in the early history of water supply in the United States, who put it: ‘‘Innocence is better than repentance.’’ (Okun 1991a).

1.5

THE EMERGENCE OF WATER AS A PUBLIC HEALTH ISSUE

The Industrial Revolution, beginning in the late eighteenth century in Britain and extending to Europe and the United States, was responsible for an explosive increase in urbanization with the development of the slums so ‘‘celebrated’’ by Dickens. It did eventually result in the English government and the northeastern states in the United States establishing agencies for addressing the terrible health conditions that emerged. Massachusetts, Pennsylvania, and New York established health boards to improve housing conditions; this resulted in the establishment of regulations for water supply and disposal of household wastes (Fig. 1.3). These efforts at regulating activities that might damage the environment led to the establishment of the public health movement. Two figures of lasting fame: Sir Edwin Chadwick, a lawyer, in England (Ives 1990), and Lemuel Shattuck, a physician (Fair 1945) in Massachusetts, who was inspired by Chadwick, were responsible for the creation of regulatory agencies and laws protecting the public from the wide range of microbial and chemical contaminants that inevitably found their way to the nearby streams and rivers that were drawn upon for water supply.

Figure 1.3 Simultaneous decline in typhoid fever death rate and rise in number of community water supplies in the United States (—— deaths per 100,000 population; water supplies: 1000s) (source: F. W. Pontius).

–

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DRINKING WATER AND PUBLIC HEALTH PROTECTION

Shattuck’s plan for the board of health for Massachusetts called for its membership to be composed of two physicians, one counselor-at-law, one chemist or natural philosopher, one civil engineer, and two persons of other professions or occupations. This comprehensive view of the needs for an agency for the protection of the public health was the springboard for the establishment of a sanitary engineering specialty within civil engineering. Shattuck had pointed out that competence in ‘‘planning and constructing public works’’ was essential to the provision of water supply and the disposal of household wastes. In 1886, the Massachusetts legislature passed ‘‘An Act to Protect the Purity of Inland Waters’’ and, to implement the Act, it called for the establishment of an engineering department in the State Board of Health. Among its activities was the establishment of the Lawrence Experiment Station, the first of its kind, which was instrumental in attracting engineers, chemists, and biologists from the Massachusetts Institute of Technology, many of whom were responsible not only for spreading the study of water-related diseases and their control but also in the introduction of community water supply systems. From a total of only 17 water supply systems in the state in 1869, the number grew to 138 in 1890 while the annual death rate from typhoid fever in the state dropped from 89 per 100,000 in 1873 to 37 in 1890, and by 1940 to 0.2 (Fair 1945). Despite the appearance of regulatory agencies, many years passed before they played a significant role in the monitoring of municipal water supply and wastewater collection, treatment, and disposal systems. Actually, there was, is, and should be far less need for regulation of drinking water quality than for regulation of wastewater discharges. In the early days of public water supplies, most were privately owned and needed to meet the requirements of the communities they served. When they were inadequate to the task, sometimes because they failed to satisfy the communities they served, but more generally because the rapid growth of the cities called for capital investments beyond the capacity of the private purveyors to meet, the community government became responsible for the water supply. When the community government itself was providing the water, there seemed to be little need for regulating the performance of their own utility as its objectives would naturally be to protect its citizenry from public health risks. A good example of this was the early history of the water supply for London, as mentioned above, where the private companies were generally loathe to invest in improvements. At the end of the nineteenth century, a Metropolitan Water Board (MWB) was created to take over responsibility for the water supply of London from eight private companies. In some other cities in England, private water companies continued to serve satisfactorily and continue to this day. The MWB established new technology and were seen to be at the leading edge of water supply technology and they set their own standards which were emulated by other communities. In the case of New York City, its early private purveyors also were inadequate to their responsibilities. The driving forces were the need to have water to prevent epidemics of yellow fever (which were not related to water) and to fight fires. One of the last private efforts was that inspired by Aaron Burr, who promised a

1.6 THE BEGINNING OF WATER TREATMENT

11

water supply as a condition of establishing the Bank of the Manhattan Company, the predecessor of the Chase Manhattan Bank. He had little interest in providing water and ‘‘this brilliant and unprincipled man suffered a series of political disasters that plunged him . . . to ruin and exile.’’ (Blake 1956). Burr’s plans were doomed. The city finally decided to develop its own supply and, after extensive study had to choose between two possible sources: the Bronx River very near the city and the Croton River some 40 miles distant. The former was considerably lower in cost but the latter promised a much better quality of water and a greater quantity for the future. The City Board of Water Commissioners Committee on Fire and Water, addressing this question in 1835 opted for the Croton and for public ownership in this language (Blake 1956): The question remains, ought the Corporation of the City of New York Committee to embark on this great work? The Committee are firmly of the opinion, that it ought to be done by no other body, corporate or personal . . . . The control of the water of the City should be in the hands of this Corporation, or in other words, in the hands of the people.

The City celebrated the delivery of high-quality water from the Croton Aqueduct to New York City by gravity at high pressure in ample quantity in 1842, then one of the largest water supplies in the world. It still provides about 15% of the water that the City uses. This costly choice was made by the city officials not to meet a regulation but to serve their constituency well. Another example is the city of Cincinnati, Ohio, which installed granular activated carbon (GAC) filtration in the 1980s though it is not required by regulations. Many cities do more than the existing regulations require because the regulations tend to be years behind our knowledge. Water officials desiring to serve their community best may find it wise to anticipate quality problems that will not be addressed by regulations for years. Unfortunately, the reception given new regulations is not always one of appreciation by many water officials but of concern for the costs that may be involved. Industry groups such as the American Water Works Association (AWWA) often challenge regulations that are in the process of being promulgated to reduce public health risks because it would increase costs and water rates. On the other hand, regulations for the quality and quantity of discharges of wastewaters to receiving waters are necessary, because the cost burden falls on the community while those who benefit are generally residents of other communities and not liable for the costs. This is also one of the reasons why the Clean Water Act (CWA) and similar earlier programs have been obliged to meet a significant share of the costs.

1.6

THE BEGINNING OF WATER TREATMENT

The relationship between source, water quality, and disease was demonstrated in the United States but much later than cholera in England and with much lower typhoid fever rates. Kober (1908) made a study of typhoid rates in American cities from

12

DRINKING WATER AND PUBLIC HEALTH PROTECTION

TABLE 1.1 Typhoid Rates in American Cities, 1902 Through 1908 Source Groundwater Impoundments and protected watersheds Small lakes Great lakes Mixed surface and groundwater Run-of-river supplies

Number of Cities

Death Rate per 100,000

4 18

18.1 18.5

8 7 5

19.3 33.1 45.7

19

61.6

Source: (Elms 1928).

1902 through 1908, summarized in Table 1.1. New York City, with its upland supply, had the lowest rate of the 61 cities with 15 typhoid deaths per 100,000 while Pittsburgh, with its run-of-river supply, suffered the highest death rate, 120 per 100,000. Filtration of water was introduced well before the turn of the nineteenth century in Europe, where run-of-river supplies were more common. An eightfold increase of filtration in the United States reduced the typhoid death rate from water supply from 1900 to 1913 by 55% (Ellms 1928). The availability of filtration mistakenly seemed to make the need for selecting better sources unnecessary. Philadelphia, which had been taking water from run-ofriver sources and had been one of the last of the large U.S. cities to adopt filtration, was suffering a typhoid death rate of 75 per 100,000 into the twentieth century. The city officials had contended that filtration was not as effective as boiling the water. In 1900, a reform mayor was determined to address the issue. A panel of distinguished engineers prepared ‘‘a report that was characterized as not having any surprises.’’ (McCarthy 1987). It recommended filtration and continued use of water from the lower Delaware and Schuykill Rivers. The report stated that ‘‘Water from upcountry sources might be preferable but the great cost of building aqueducts and reservoirs made that option very expensive and really unnecessary since filtration would provide safe water.’’ In 1911, before the filters were operational, a typhoid outbreak in Philadelphia resulted in 1063 deaths. After filtration, the death rate dropped to 13 per 100,000, still a relatively high figure. Philadelphia still takes most of its water from the ‘‘mouth’’ (more properly, the ‘‘anus’’) of the Delaware River and has had to adopt Herculean methods to deliver water of good quality ever since. A multimedia study of environmental health risks in Philadelphia in the 1980s determined that the water supply posed the highest risk of all sources of pollution in the city. Since then improved treatment processes along with stricter USEPA standards have been introduced. Many cities have no alternatives and are obliged to draw from run-of-river sources. Slow sand filtration became the treatment of choice in Massachusetts in

1.7 THE CHEMICAL REVOLUTION

13

the 1870s. In the 1890s, the Louisville Water Company, which took water from the Ohio River, introduced sedimentation of the water prior to filtration. For better removal of turbidity, they introduced chemical coagulation and rapid sand filtration. The introduction of chlorination for disinfection of water for municipal water supply took place in Boonton, New Jersey, in 1908 following decades of study of the use of chlorine in Europe and the United States (Baker 1948). It clearly was the greatest step in the reduction of the transmission of infectious diseases via water supply. An example of the role of chlorine was the effect it had in a city drawing water from a clear lake. Chlorine reduced the annual typhoid death rate from about 20 to 2 per 100,000 population, which was then reduced to virtually zero with the addition of filtration (Fair et al. 1968). Together with pasteurization of milk and better handling of human wastes, typhoid virtually disappeared in the United States by the middle of the twentieth century.

1.7

THE CHEMICAL REVOLUTION

While infectious disease was brought under control, although other diseases emerged later, two other problems arose. The first was that water treatment tools were believed to be so effective, engineers became sanguine about the need to seek waters of high quality; treatment would make it safe. The conventional treatment of the midtwentieth century, which remains the conventional treatment now, at the beginning of the twenty-first century—chemical coagulation, rapid sand filtration, and chlorination—does little to remove the trace synthetic organic chemicals in ambient water resulting from the post World War II surge in industrial development what has been labeled the ‘‘chemical revolution’’ (Okun 1996). The second problem is truly ironic—the life-saving treatment, chlorination, increases the risk from synthetic organic chemicals created by the chlorine itself. Other disinfection byproducts have surfaced and added to the problem of the trace synthetic organic chemicals discharged from industry and households using a wide range of such chemicals for house and garden. The first published material about disinfection byproducts (DBPs) emanated from Rook’s work at the Rotterdam water treatment plant, which drew water from the mouth of the Rhine River (Bellar et al. 1974). While it had been picked up quickly by USEPA, the potential had been recognized 5 years earlier. Dr. Joshua Lederberg, a Nobel Prize geneticist, who had been somewhat active in drinking water issues, wrote a 1969 syndicated column in the Washington Post. One column was headlined ‘‘We’re so accustomed to using chlorine that we tend to overlook its toxicity’’ (Lederberg 1969): What little we do know of the chemistry of chlorine reactions is portentous. It should sometimes react . . . to form substances that may eventually reach and react with genetic material, DNA, of body cells . . . That chlorine is also intended to inactivate viruses should provoke questions about the production of mutagens in view of the close similarity between viruses and genes.

14

DRINKING WATER AND PUBLIC HEALTH PROTECTION

USEPA was created in 1970, but Lederberg failed in attempts to attract funds to follow this up with his research team. The discovery of trihalomethanes and other disinfection byproducts and concerns regarding the potential cancer risks associated with chloroform would be a major driving force behind passage of the 1974 SDWA.

1.8

THE INTRODUCTION OF REGULATIONS

In the absence of regulations, many cities adopted practices that were believed to be the most appropriate for their own conditions on the recommendations of professional engineers and water scientists. As noted above, the spread of disease had been controlled in large measure by the quarantine of the sick. It was not unreasonable, therefore, for federal authority over the control of the spread of disease via water to be initially addressed by the U.S. Congress in the Interstate Quarantine Act of 1893 (United States Statutes 1893). Under the Act, the surgeon general of the U.S. Public Health Service (USPHS) was empowered ‘‘to make and enforce such regulations as are necessary to prevent the introduction, transmission, or spread of communicable disease from foreign countries into the states or possessions, or from one state or possession into any other state or possession.’’ Interstate regulations were first promulgated in 1894 with the first water-related regulation adopted in 1912, which prohibited the use of the common cup on carriers in interstate commerce (McDermott 1973). The first federal drinking water standards were adopted in 1914. The USPHS was then part of the U.S. Treasury Department and was charged with responsibility for the health care of the sailors of the Merchant Marine. The surgeon general of the USPHS recommended and the Treasury Department adopted standards for drinking water to be supplied to the public on interstate carriers, then called ‘‘Treasury Standards.’’ Because the group that was charged with developing the standards could not agree on physical and chemical parameters, only a bacterial standard of 100 microorganisms per milliliter was adopted. The organism adopted was Bacteria coli, now known as Escherichia coli. It was further stipulated that not more than one of five 10-mL portions (2 Bacteria coli per 100 mL) would be permitted. (Borchardt and Walton 1971) These coliform organisms were not themselves pathogenic but, originating in large numbers in the human colon and found in feces, they served as a surrogate for enteric pathogens because they were more resistant to removal and were present in large numbers and, if they were not present, it could be inferred that the enteric pathogens likely would not be present. Many local and state officials adopted the standard and monitored the water systems that served interstate carriers for themselves and on behalf of the Treasury Department. A federal commitment was made in 1915 to review the regulations on a regular basis. By 1925, most large cities drawing water from run-of-river sources were already using filtration and chlorination and having little difficulty in meeting the 1914 coliform standard of 2 100 mL 1 (2 coliforms per milliliter). Following a principle of attainability, the standard was tightened to 1 100 mL 1. In addition, standards

1.8 THE INTRODUCTION OF REGULATIONS

15

were established for physical and some chemical constituents, including lead, copper, zinc, and dissolved solids (USPHS 1925). The 1925 standards introduced the concept of relative risk. The preamble stated in part: The first step toward the establishment of standards which will ensure safety of water supplies conforming to them is to agree upon some criterion of safety. This is necessary because ‘‘safety’’ in water supplies, as they are actually produced, is relative and quantitative, not absolute. Thus, to state that a water supply is ‘‘safe’’ does not necessarily signify that no risk is ever incurred in drinking it. What is usually meant, and all that can be asserted from any evidence at hand is that the danger, if any, is so small that it cannot be discovered by available means of observation.

In 1941, an advisory committee for revision of the 1925 standards was assembled by the USPHS, composed of representatives of federal and state agencies, scientific associations, and members at large, which produced the 1942 standards (USPHS 1943). One new initiative was the introduction of requirements for monitoring microbial water quality in the distribution system, with specifications for the minimum number of samples to be collected each month according to the size of the community. Specifications for the laboratories and procedures involved were provided. Maximum permissible concentrations were established for lead, fluoride, arsenic, and selenium as well as for salts of barium, hexavalent chromium, heavy metals, and other substances having deleterious physiological effects. Maximum concentrations where other alternative sources were not available were set for copper, the total of iron and manganese, zinc, chlorides, sulfates, phenolic compounds, total solids, and alkalinity. Only minor changes were introduced in 1946 (USPHS 1946). Publication in the Federal Register was introduced, assuring more rapid dissemination of changes that might be made, one of which was the authorization in March 1957 of the use of the membrane filter procedure for the bacteriological examination of water samples. World War II (for the United States, 1942–1946) was the first war where deaths of American troops by infectious disease did not exceed deaths in combat. Steps had been introduced to reduce exposure to mosquitoes that were responsible for malaria and other related diseases in the tropics and facilities were provided to assure chlorination of the drinking water. In the postwar period, and driven by the need to make up for years during which the construction of state-side water-related civilian infrastructure had been dormant, attention was turned to making heavy investments for urban water supply. The need for standards was apparent. Dr. Abel Wolman (1960) addressed this issue thus: From its beginning, society by one means or another, has surrounded itself with restraints. These have had, for the most part, empiric origins—moral, ethical, economic, or spiritual. All the restraints have had the common basis of an assumed benefit to the

16

DRINKING WATER AND PUBLIC HEALTH PROTECTION

particular society establishing them. As societies became more complex and more sophisticated, efforts towards both standardization and restraint became more frequent, more necessary, and presumably more empiric, although examples of the last are not as numerous as one might expect.

He then went on to characterize the types of standards that are necessary:  Regularization of techniques of measurement;  Establishment of limits of concentration or density of biologic life and physical and chemical constituents;  Regularization of administrative practice;  Regularization of legislative fiat; and  Specification of materials.

The increasing complexity of the issues is exemplified in all that follows, including not only in the specific regulations required but also in the methodologies of reaching consensus among the many stakeholders involved. The beginning of the ‘‘chemical revolution’’ and regulating the thousands of synthetic organic compounds (SOCs) that are being invented annually and that find their way into the environment and into waters drawn on for drinking began with the 1962 update of the federal Drinking Water Standards. The establishment of the 1962 USPHS standards involved examining many new issues, including two important problems not previously addressed: radioactivity and SOCs. A new 18-member Advisory Committee was established representing 13 professional and scientific organizations that included consulting engineers, state officials, industry, academics, and water utility executives as well as personnel from the Food and Drug Administration and the U.S. Geological Survey. In addition, 10 officers of the USPHS formed a Technical Subcommittee that, with a six-member Task Force on Toxicology, were advisory to the main Committee (USPHS 1962). The 1962 USPHS standards were by far the most comprehensive to that date. They included three physical characteristics, odor, color, and turbidity; the last was the most controversial. The turbidity was established at 5 units over the objections of many on the committee from communities that were filtering their waters and who recommended 1 unit, which they could easily meet. Representatives from the northeast, where impounded surface sources were used without filtration, would have had to provide filtration, a measure they believed unnecessary. The bacteriological quality requirement was modified, essentially allowing no more than a monthly average of one coliform per milliliter when the membrane filter technique is used. The chemical standards were the most difficult to address. Fourteen parameters were listed, but the SOC problem was resolved with the introduction of a Carbon Chloroform Extract (CCE) standard of 0.2 mg L 1. A manual was prepared describing the procedure to be used; adsorption of organics by passing a sample of the water through a granular activated carbon (GAC) filter and then desorbing the filter with chloroform (Middleton et al. 1962). The standard was meaningless as a measure of

1.9 PRELUDE TO THE 1974 SAFE DRINKING WATER ACT

17

public health risk, because SOCs could not be distinguished from natural organics that are generally of little health consequence, except when they are precursors for chlorination and the creation of trihalomethanes (THMs). But the CCE standard was an attempt to address the SOC problem. The treatment to be provided to remove SOCs was the installation of GAC filters in the treatment train. Forty years later, only a handful of GAC filter plants are being used for treating the most vulnerable public water supplies, those drawing from run-of-river sources. It can be assumed that, at this writing, few supplies that draw from large rivers are removing SOCs that may be present. The 1962 Standards did introduce two principles that had not been incorporated in previous standards. The first was that ‘‘The water supply should be taken from the most desirable source which is feasible, and effort should be made to prevent or control pollution of the source.’’ The second issue was the absence of regulations related to availability of service. A community might be found to be violating the standards if one of the standards is not met but no violation is involved if water service is curtailed because of drought or mechanical failure. The 1962 Standards state ‘‘Approval of water supplies shall be dependent in part on: . . . adequate capacity to meet peak demands without development of low pressures or other health hazards.’’ The 1962 Standards were accepted by all the states, with minor modifications either as regulations or guidelines, but were binding only on about two percent of the communities, those that served interstate carriers (Train 1974).

1.9

PRELUDE TO THE 1974 SAFE DRINKING WATER ACT

On June 3, 1968, the keynote speaker at the Annual Conference of the AWWA quoted from a report of the Secretary of the U.S. Department of Health Education and Welfare (USDHEW 1967): ‘‘Fifty million Americans drink water that does not meet Public Health Service drinking water standards. Another 45 million Americans drink water that has not been tested by the Public Health Service.’’ The AWWA officials were reluctant to publish the paper because it appeared to be too critical of the water supply industry. They acceded only when the author happily agreed to allow rebuttals (Okun 1969). The task force that prepared the report was not satisfied that the USPHS drinking water standards adequately reflect the health need of the people of the United States. Several issues troubled them. Little information is available on the health implications of trace substances that may produce disease after exposure over long periods of time. Health experts have repeatedly pointed out that grave, delayed physical manifestations can result from repeated exposure to concentrations of environmental pollutants so small that victims do not report symptoms to a physician. Furthermore, an individually acceptable amount of water pollution, added to a bearable amount of air pollution, plus nuisances from noise and congestion, can produce a totally unacceptable health environment. It is entirely possible that the biological effects of these environmental hazards, some of which reach individuals

18

DRINKING WATER AND PUBLIC HEALTH PROTECTION

slowly and silently over decades or generations, will first begin to reveal themselves after their impact has become irreversible. In a prescient paper on cancer hazards, Hueper (1960) stated: It is obvious that with the rapidly increasing urbanization and industrialization of the country and the greatly increased demand on the present resources of water from lakes, rivers, and underground reservoirs, the danger of cancer hazards will grow considerably within the foreseeable future.

Hueper (1960) went on to report that studies in Holland revealed that cities drawing water from polluted rivers had higher cancer death rates than those taking water from higher-quality underground sources. At about the same time, the Genetic Study Section of the National Institutes of Health (NIH undated) reported that a number of widely used chemicals are known to induce genetic damage in some organisms and that chemicals mutagenic to one species are likely to be mutagenic to others. They believed that when large populations are exposed to highly mutagenic compounds, and they are not demonstrably mutagenic to individuals, the total number of deleterious mutations in the whole population over an extended period of time could be significant. In 1969, at the beginning of a review of the 1962 standards, the USPHS Bureau of Water Hygiene undertook a comprehensive survey of water supplies in the United States, known as the Community Water Supply Study (CWSS) (USPHS 1970a). A total of 969 public water systems, representing about five percent of the total number of systems in the United States serving 18 million people, about 12% of the population being served, were tested (USPHS 1970b). About 41% of the systems served did not meet the guidelines in the 1962 Standards. Deficiencies were found in source protection, disinfection, clarification, pressure in the distribution systems, and combinations of these. The small systems, mainly those serving fewer than 500 people, had the greatest difficulty in maintaining water quality. The study revealed that several million people were being supplied with water of inadequate quality and about 360,000 people were being supplied with potentially dangerous drinking water. The results of the CWSS generated interest in federal legislation that would bring all community water systems under the purview of federal regulations. In 1972, a report of an investigation of the quality of Mississippi River water, as withdrawn from the Carrolton filtration plant in New Orleans, extracted by GAC filtration and a solvent, revealed 36 organic chemicals in the finished water (USEPA 1972). Later, the U.S. General Accounting Office, an agency of the Congress, released a report of the results of an investigation of 446 community water supply systems in six states around the country and found that only 60 of them fully complied with the bacterial and sampling requirements of the 1962 Standards (Symons 1974). Bacteriological and chemical monitoring were inadequate in five of the states. In addition to government concern, public organizations and the press had begun to give attention to water supply issues. A three-part series in Consumer Reports drew attention to the organic contaminants in New Orleans drinking water (Harris

1.10 DRINKING WATER IN DEVELOPING COUNTRIES

19

and Brecher 1974) Several points were made at the outset of the series that are appropriate today: New Orleans, like many other American cities gets its drinking water from a heavily polluted source . . . . Many industries discharge their wastes into the river and many upriver cities discharge their sewage into it . . . runoff from farmland carries a wide variety of pesticides, herbicides, fertilizers, and other agricultural chemicals that swell the Mississippi’s pollution burden. Few New Orleans residents are alarmed. They have been repeatedly assured by city officials that their water, processed according to established water-treatment principles, meets the drinking water standards of the US Public Health Sevice and is ‘‘safe.’’ And so it probably is, if one takes ‘‘safe’’ to mean that the water won’t cause typhoid, cholera, or other bacterial diseases—the diseases that the standard water treatment is designed to prevent. In 1969, the Federal Water Pollution Control Administration sampled New Orleans drinking water . . . . Thirty six (organic compounds) were identified; others were found but could not be identified. Three of the organic chemicals (chloroform, benzene, and bis-chloroethyl ether) were carcinogens, shown to cause cancer in animal experiments. Three others were toxic, producing liver damage in animals when consumed even in small quantities for long periods. The long-term effects . . . are unknown.

The Environmental Defense Fund (EDF) conducted an epidemiologic study in the New Orleans area that compared cancer death rates from communities using lower Mississippi River water as a source with those from nearby communities that were using groundwater sources. The report indicating higher cancer rates among those using the Mississippi River Water was released to the press on November 7, 1974 (The States-Item 1974; Page et al. 1974, 1976). Further publicity followed on December 5, when Dan Rather on CBS aired nationally a program titled ‘‘Caution, drinking water may be dangerous to your health.’’ It is interesting to note that upon learning of this situation and the passage of the SDWA, the City of Vicksburg, which had been drawing its water from the Mississippi River, shifted its source to groundwater. These events, together with the revelation at the time that the chlorine used to make water microbiologically safe would create a family of compounds, trihalomethanes, that were themselves believed to be carcinogenic, led to the passage of the 1974 SDWA.

1.10

DRINKING WATER IN DEVELOPING COUNTRIES

The safety of drinking water cannot be examined without considering the problems of drinking water supply and safety in the countries of Asia, Africa, and Latin America. In the industrialized world, attempts are being made to eliminate the use

20

DRINKING WATER AND PUBLIC HEALTH PROTECTION

of chlorine for disinfection. Several cities in the Netherlands have abandoned chlorine and other disinfectants entirely because of their concern for DBPs. On the other hand, the situation in the developing world is so serious that the availability of chlorine for every water supply would reduce infant mortality by about 90%. In 1991, cholera broke out in the Pacific coast of Peru, most probably introduced by maritime traffic from Asia by the discharge of ballast water into the coastal zone from which fish are taken for food, often eaten uncooked. Within two weeks, most of the Peruvian coast, where half of the 22 million Peruvians reside, was host to the disease. Of the some 322,000 cases reported for the year, 55% occurred in the first 12 weeks of the epidemic. The case fatality rate was 0.9% signifying about 30,000 deaths in 1991. By the end of the year, 15 other countries in the Americas, including the United States and Canada, had reported outbreaks caused by the same strain of cholera (Salazar-Lindo and Alegre 1993). Because of its explosive and urban character, contaminated water was identified as the medium for the rapid spread and the intensity of the disease in the cities. Most of the cities had conventional water treatment plants with filtration for water drawn from surface sources. Investigation revealed that chlorination was curtailed and often entirely absent when well water was used. Some Peruvian officials blamed the USEPA for the failure to use chlorine because it had been trumpeting the cancer risks associated with chlorine in water supplies (Anderson 1991). A serious cholera outbreak occurred in early 2001 in KwaZulu-Natal in the Republic of South Africa, with more than 30,000 cases and some 100 deaths (Yahoo! 2001). At the height of the outbreak, more than 1000 cases were being reported daily. The reason stated was that the people do not have access to tapwater and are obliged to rely on water from very polluted streams. Even where ‘‘bleach’’ is available, it is not used because it is believed to interfere with fertility. Boiling is not feasible, as firewood is scarce. In 1980, only 44% of the total population of the developing countries was being served with water by any means, including carrying water of questionable quality long distances from standposts. In urban areas, 69% of the population was being served and very little of that can be considered safe because few cities maintained 24-hour service. When water pressure in distribution pipes is absent, which is most of the day, treated drinking water inevitably becomes contaminated from infiltration of groundwater that is highly contaminated because sewerage systems are absent or in poor condition. International agencies such as the World Health Organization, the World Bank, the regional development banks, and the developed countries along with the developing countries designated the 1980s the ‘‘international drinking water supply and sanitation decade,’’during which special efforts were to be made to bring water to the people of the developing world. Ten years later, the population in the developing countries with water supplies had increased to 69%, but the number of people unserved in urban areas had increased by 31 million (Okun 1991b). The rate of urbanization in Asia Africa and Latin America is so great that, even with intensified financial support in grants and loans, the number of urban residents without water service is growing. More important is that those who are counted as having water

1.11 THE FUTURE OF PUBLIC WATER SUPPLY

21

service do not have safe water by any standard. All that is required to reduce the infant death rate is the type of treatment facilities and their operation and maintenance that was conventional in the industrial world almost a hundred years ago. Given the nature of world travel today, it is clearly in the self-interest of the industrialized countries to help the developing countries provide water that at least meets 1925 U.S. standards. This would reduce infectious disease that is the major health risk to people and visitors in these countries.

1.11

THE FUTURE OF PUBLIC WATER SUPPLY

The history of the monitoring and control of drinking water quality from its earliest days through the present has lessons for those charged with protecting the public health, particularly for those responsible for providing the drinking water to their constituents. This volume demonstrates, if nothing else, that setting standards is a difficult and lengthy procedure. It may be many years, even decades between the time a new risk surfaces and regulations for its control are established and many years more before they are published. Also, years must be allowed for constructing the necessary facilities for eliminating the risks. It behooves the professionals in water utility leadership to educate themselves concerning new risks and prepare to address them before the standards appear in the Federal Register. The object is to minimize health risks to the public. Failure, or the perception of failure, drives the public to bottled water with its own risks and costs that are a hardship for a sizable fraction of the population. A not unrelated issue that is growing in importance as our population ages is the significant percent of the population that is more vulnerable to contaminants by virtue of compromised immune systems. Standards for this population may need to be promulgated. A similar solution is now being proposed in addressing the quality of water suitable for the potable reuse of wastewaters. Wastewaters contain a large number and a great variety of SOCs. The California Department of Health Services is proposing for the regulation of water quality for groundwater recharge with reclaimed wastewater to potable water aquifers drawn on for drinking water that total organic carbon (TOC) limits be set (California Code of Regulations 2001). Again, the carbon compounds may be innocuous or toxic, but in any case a maximum contaminant level (MCL) for TOC of wastewaters is hardly appropriate to assure drinking water safety. This principle carried over to the 1976 USEPA National Interim Primary Drinking Water Regulations, referred to by this language in Appendix A as ‘‘background used in developing the national interim primary drinking water regulations’’: Protection of water that poses no threat to the consumer’s health depends on continuous protection. Because of human frailties associated with protection, priority should be given to selection of the purest source. Polluted sources should not be used unless other sources are economically unavailable, and then only when personnel, equipment, and

22

DRINKING WATER AND PUBLIC HEALTH PROTECTION

operating procedures can be depended upon to purify and otherwise continually protect the drinking water supply.

This principle is being ignored today, in part because of our faith in treatment technology. Reclaimed wastewater is being proposed as a source for drinking water supplies. Wastewater is hardly likely to be the purest source, and its use for potable reuse is resisted by consumers. Use of reclaimed wastewater for nonpotable purposes is currently being practiced in many hundreds of communities in the United States (Okun 1997, 2000), and will be increasingly considered for relieving the pressure on limited high-quality resources.

REFERENCES Anderson, C. 1991. Cholera epidemic traced to risk miscalculation. Nature 354:255. Baker, M. N. 1948. The Quest for Pure Water. Denver: American Water Works Association. Bellar, T. A., J. J. Lichtenberg, and R. C. Kroner. 1974. The occurrence of organohalides in chlorinated drinking water. J. Am. Water Works Assoc. 66:703. Blake, N. M. 1956. Water for the Cities. Syracuse, NY: Syracuse University Press. Borchardt, J. A. and G. Walton. 1971. Water Quality and Treatment, 3rd ed. New York: McGraw-Hill. California Code of Regulations. 2001. Title 22. Draft Recycling Criteria. Sacramento: State Department of Health Services. Cosgrove, J. J. 1909. History of Sanitation. Pittsburgh, PA: Standard Sanitary Manufacturing Co. Ellms, J. W. 1928. Water Purification. New York: McGraw-Hill. Fair, G. M. 1945. Engineers and engineering in the Massachusetts State Board of Health. New Engl. J. Med. 232:443–446. Fair, G. M., J. C. Geyer, and D. A. Okun. 1968. Water Purification and Wastewater Treatment and Disposal, Vol. 2. New York: Wiley. Frontinus, S. J. A.D. 97. The Two Books on the Water Supply of the City of Rome., transl. Clemens Herschel, 1899. Boston: Dana Estes and Company. Harris, R. H. and E. M. Brecher. 1974. Is the water safe to drink? Part I. The problem. Part II. How to make it safe. Part III. What you can do. Consumer Reports 436 (June), 538 (July), 623 (August). Hueper, W. C. 1960. Cancer hazards from natural and artificial water pollutants. Proc. Conf. Physiol. Aspects Water Quality. Washington, DC: USPHS (U.S. Public Health Service). Ives, K. J. 1990. The Chadwick Centenary. The Life and Times of Sir Edwin Chadwick: 1800– 1890. London: University College. Kober, G. M. 1908. Conservation of life and health by improved water supply. Engineering Record 57. Lederberg, J. 1969. We’re so accustomed to using chlorine that we tend to overlook its toxicity. The Washington Post May 3, p. A15. Longmate, N. 1966. King Cholera: The Biography of a Disease. London: Hamish Hamilton.

REFERENCES

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McCarthy, M. P. 1987. Typhoid and the Politics of Public Health in 19th-Century Philadelphia. Philadelphia: American Philosophical Society. McDermott, J. H. 1973. Federal drinking water standards—past, present, and future. J. Environ. Eng. Div. Am. Soc. Civil Eng. EE4(99):469. Middleton, F. M., A. A. Rosen, and Burttschell. 1962. Manual for recovery and identification of organic chemicals in water. J. Am. Water Works Assoc. 54:223–227. National Institutes of Health. Undated. Report of Chemical Mutagens as a Possible Health Hazard. Bethesda, MD: NIH Genetics Study Section. Okun, D. A. 1969. Alternatives in water supply. J. Am. Water Works Assoc. 61:5:215–224. Okun, D. A. 1991a. Clean water and how to get it. J. New Engl. Water Works Assoc. 105(1):110. Okun, D. A. 1991b. A water and sanitation strategy for the developing world. Environment 33(8):16. Washington, DC: Heldref Publications. Okun, D. A. 1996. From cholera to cancer to cryptosporidiosis. J. Environ. Eng. 122:453–458. Okun, D. A. 1997. Distributing reclaimed water through dual systems. J. Am. Water Works Assoc. 89(11):52–64. Okun, D. A. 2000. Water reclamation and unrestricted nonpotable reuse: A new tool in urban water management. Annual Rev. Public Health 21:223–245. Page, T., E. Talbot, and R. H. Harris. 1974. The Implication of Cancer-Causing Substances in Mississippi River Water. Washington, DC: Environmental Defense Fund. Page, T., R. H. Harris, and S. S. Epstein. 1976. Drinking water and cancer mortality in Louisiana. Science 193:55. Salazar-Lindo, E. and M. Alegre. 1993. The Peruvian cholera epidemic and the role of chlorination in its control and prevention. In Safety of Water Disinfection; Balancing Chemical and Microbial Risks, G. Craun, ed. Washington, DC: International Life Sciences Institute. Snow, J. 1936. Snow on Cholera. England: Oxford Univ. Press. Symons, G. E. 1974. That GAO Report. J. Am. Water Works Assoc. 66:275. The States-Item. 1974. Cancer victims could be reduced—deaths tied to New Orleans water 98(129)1 (Nov. 7). Train, R. S. 1974. Facing the real cost of clean water. J. Am. Water Works Assoc. 66:562. United Nations. 1958. Water for Industrial Use. UN Report E=3058ST=ECA=50. New York: Economic and Social Council. United States Statutes. 1893. Interstate Quarantine Act of 1893. U.S. Statutes at Large. Chap. 114, Vol. 27, p. 449, Feb. 15. USDHEW (U.S. Department of Health, Education and Welfare). 1967. A Strategy for a Livable Environment. Washington, DC: HEW. USEPA. 1972. Industrial Pollution of the Lower Mississippi River in Louisiana. Dallas: USEPA Region VI. USPHS. 1925. Report of the Advisory Committee on Official Water Standards. Public Health Reports 40:693. USPHS. 1943. Public Health Service Drinking Water Standards and Manual of Recommended Water Sanitation Practice. Public Health Reports 56:69. USPHS. 1946. Public Health Service Drinking Water Standards. Public Health Reports 61:371.

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USPHS. 1962. Public Health Service Drinking Water Standards. Washington, DC: HEW. USPHS. 1970a. Community Water Supply Study: Analysis of National Survey Findings. PB214982. Springfield, VA: National Technical Information Service. USPHS. 1970b. Community Water Supply Study: Significance of National Findings. PB215198=BE. Springfield, VA: National Technical Information Service. Wolman, A. 1960. Concepts of policy in the formulation of so-called standards of health and safety. J. Am. Water Works Assoc. 52:11. Yahoo! Asia—News. 2001. Cholera infections sky-rocket in South Africa (Feb. 1).

2 IMPROVING WATERBORNE DISEASE SURVEILLANCE FLOYD J. FROST, Ph.D. The Lovelace Institutes, Albuquerque, New Mexico

REBECCA L. CALDERON, Ph.D. National Health and Environmental Effects Laboratory, U.S. Environmental Protection Agency, Research Triangle Park, North Carolina

GUNTHER F. CRAUN, P.E., M.P.H., D.E.E. Gunther F. Craun and Associates, Staunton, Virginia

2.1

INTRODUCTION

Public health surveillance has played a key role in controlling the spread of communicable disease and identifying the need for specific public health practices, such as the filtration and chlorination of drinking water supplies. However, the characteristics of waterborne outbreaks since the early 1990s have raised questions about whether current water treatment practices can prevent transmission of some enteric pathogens (D’Antonio et al. 1985, Hayes et al. 1989, Leland et al. 1993, MacKenzie et al. 1994). In addition, one analysis suggested that a significant fraction of all enteric disease in the United States may be due to drinking water (Bennett et al. 1987). Another study Disclaimer: The views expressed in this chapter are those of the individual authors and do not necessarily reflect the views and policies of the USEPA. The chapter has been subject to the Agency’s peer and administrative review and approved for publication. Drinking Water Regulation and Health, Edited by Frederick W. Pontius. ISBN 0-471-41554-5 # 2003 John Wiley & Sons, Inc.

25

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found evidence that consuming surface-derived drinking water which meets current U.S. Environmental Protection Agency (USEPA) drinking water standards may significantly increase the risk of enteric illness (Payment et al. 1991). These concerns have motivated the U.S. Congress to require USEPA to prepare a report on the magnitude of epidemic and endemic waterborne disease in the United States. Even as the needs increase for better information about waterborne disease occurrence and causes, some have suggested that our disease surveillance system is in a state of crisis and may possibly collapse (Berkelman et al. 1994). Another study revealed that state health departments often cannot dedicate any staff to enteric disease surveillance (Frost et al. 1995). Current concerns over the preparedness for detecting and controlling bioterrorism attacks have also motivated interest in the adequacy of waterborne disease surveillance. In this chapter, issues relating to disease surveillance and outbreak investigations are presented to assist readers in understanding the strengths and weaknesses of current waterborne disease surveillance and outbreak detection programs and to suggest additional steps to strengthen the system. With limited public health resources available, it is important to carefully consider the goals and approaches to waterborne disease surveillance. In addition to addressing the information needs of governmental disease control programs, it is essential to ensure that the information needs of the drinking water industry, the regulatory agencies, and the public are best served. It may also be essential for drinking water utilities to participate in and, perhaps, help fund these surveillance systems.

2.2

BACKGROUND

It is increasingly accepted that additional information is needed about the occurrence and causes of waterborne disease, both epidemic and endemic. The Centers for Disease Control (CDC) funded ‘‘emerging pathogen’’ surveillance projects in selected state health departments, in part to improve surveillance for several important waterborne agents. In New York City (NYC), the Department of the Environment (DEP), responsible for drinking water treatment and delivery, convened a panel of public health experts in 1994 to evaluate current health department disease surveillance programs. The panel recommended specific waterborne disease surveillance activities and epidemiologic studies to determine endemic waterborne disease risks associated with use of unfiltered surface water sources (Table 2.1) (Craun et al. 1994). Efforts to improve NYC waterborne disease surveillance are funded by the NYC DEP, the first time this has occurred for a drinking water utility in the United States. An option for improving waterborne disease surveillance is to build on the current surveillance programs in place in most state and local health departments. This system is based on voluntary disease reporting by healthcare providers and clinical laboratories. However, a number of limitations of the system have been identified, and other factors may have already significantly reduced the effectiveness of traditional disease surveillance programs. Some pathogens, such as Cryptospori-

2.2 BACKGROUND

27

TABLE 2.1 New York City Panel Recommendations on Waterborne Disease Surveillance Designate an individual who is specifically responsible for coordinating waterborne disease surveillance Conduct special surveillance studies of nursing and retirement home populations Conduct surveillance in managed care populations Monitor visits to emergency rooms Conduct surveillance of high-risk populations Monitor sales of prescription and nonprescription medications

dium, are often difficult to diagnose, and other pathogens may exist for which there are no known diagnostic tests or no tests available for routine use. Changes in healthcare access and delivery practices may reduce the number of patients seeking healthcare and, also, the chances that medically attended diseases are confirmed by laboratory tests. An outbreak resulting in many medically attended illnesses in a large city could be unrecognized, as almost happened in the Milwaukee outbreak. In that outbreak, a large increase in the occurrence of diarrheal illness occurred around March 30–31, 1993. On Thursday, April 1, 1993 a pharmacist noted a dramatic increase in sales of over-the-counter antidiarrheal and anticramping medications. Normally his pharmacy sold $30 a day of such medications. Starting that Thursday, drug sales increased to approximately $500–$600 a day, or 17–20 times the normal sales. The increased sales continued on Friday, as a result of which the pharmacy sold most of its supply of antidiarrheal medications. The pharmacist called the health department to inquire about excessive reports of diarrhea or intestinal illness. The health department was unaware of any outbreak. On Saturday the increased sales continued so the pharmacist contacted the three local television stations to report what he believed to be a major occurrence of diarrheal disease in the city. On Sunday night his report was carried on the evening news for one station and by Wednesday, April, 7, the outbreak was confirmed by the Milwaukee Health Department. In the case of the Milwaukee outbreak, few of the people sought medical care for their diarrhea. However, even in situations where care was sought, it is possible that no one physician would notice an outbreak. For example, if many different healthcare providers treated the patients, it is possible that no one provider would recognize excess occurrences of illness. In addition, the existence of health effects in a small but extremely susceptible subpopulation might be difficult to detect because of the small number of people at risk. As some changes have made it more difficult to detect outbreaks, other changes present new disease surveillance opportunities. Computerization of patient records, healthcare and laboratory workloads, prescription and nonprescription pharmaceutical sales, and calls to nurse hotlines are potential new tools for more effective and less costly disease surveillance. Technological advancements, such as detection of antigen or antibodies specific to a pathogen in sera, stools, and other secretions, may

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improve detection of etiological agents. These may also allow detection of infections in the absence of disease. To better evaluate the current and alternative surveillance opportunities, five questions have been selected for discussion in this chapter: 1. What are the limitations of our current disease surveillance systems? 2. Should the early detection of outbreaks be the primary goal of a surveillance system and, if so, how can it be best achieved? 3. What is meant by endemic or background rates of disease, can some of this endemic disease be attributable to drinking water, and what should water utilities do to better understand these risks? 4. Can findings from outbreak investigations be used to estimate the unreported burden of enteric disease attributable to drinking water? 5. Since only a fraction of infected persons become ill from most enteric infections, should expanded surveillance programs monitor infection rather than illness?

2.3 LIMITATIONS OF THE CURRENT DISEASE SURVEILLANCE SYSTEMS What are the limitations of our current disease surveillance systems? Detection of waterborne disease outbreaks depends, in part, on a state–federal system of notifiable or reportable diseases. Disease reporting is primarily the responsibility of healthcare providers and diagnostic laboratories. State or local laws require the reporting of certain diseases. Primary responsibility for disease surveillance rests with the state or local public health authorities. Most state surveillance systems are ‘‘passive,’’ in that reports are sent to the state or local health department by cooperative health care providers or laboratories. Providers and laboratories usually receive little encouragement from the health department to report illnesses. Government enforcement of reporting requirements is minimal. An ‘‘active’’ system will routinely contact some or all healthcare providers and laboratories, asking for illness reports (Table 2.2) (Foster 1990). It has long been recognized that both passive and active disease reporting incompletely ascertain the level of disease in the community. The level of completeness varies by disease, by state, and by areas or populations within a state (Corba et al. 1989). For example, reporting is likely to be more complete for severe diseases such as hemorrhagic E. coli than for milder infections, such as Norwalk virus gastroenteritis. Laboratories tend to be much better at reporting their findings than are physicians (Foster 1990). Even within an area, there can be great variations in reporting, depending on the interest of clinical laboratories and the dedication of diagnosing physicians (Corba et al. 1989). For example, for pathogens that are new or where there are questions about the mode of transmission, reporting may be more

2.3 LIMITATIONS OF THE CURRENT DISEASE SURVEILLANCE SYSTEMS

TABLE 2.2 Mandatory reporting Passive Active

Enhanced

29

Surveillance System Definitions A diagnosed case of disease is required, by law, to be reported; for example, in the case of cryptosporidiosis, all diagnosed cases are to be reported Disease reports are submitted by providers and=or laboratories without specific follow-up by the health department Providers and=or laboratories are contacted to encourage diseases reporting; because of resource requirements, this is usually done as a special project for a limited duration of time Special additional efforts are made to encourage disease reporting; this might include news releases, posters at strategic locations, presentation to special populations, or health surveys in communities with water quality problems

complete than for agents that are common, where the mode of transmission is well known and where public health intervention is less necessary. In addition to incomplete reporting of diagnosed illnesses, only a portion of all infections will ever be medically attended. As illustrated in Figure 2.1, only a fraction of infections will lead to illness. These infected persons may be unaware of their infection. In other cases, such as sometimes occurs as a result of childhood Giardia infection, the child fails to thrive but experiences none of the classic symptoms of giardiasis. When symptoms occur, they may be mild and=or may resolve in a short period of time. In this case, the person may not seek medical care or may simply visit a pharmacy to obtain medication to alleviate their symptoms. In the case of Milwaukee, despite the large number of reported cases of cryptosporidiosis, very few people visited their physician and few stool specimens were positive for Cryptosporidium oocysts.

Figure 2.1

Disease pyramid.

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If the person seeks healthcare, the physician may fail to correctly diagnose the infection, since in many cases symptoms are not sufficiently specific to accurately identify the pathogen. If misdiagnosed and the infection resolves itself, the patient may not seek additional healthcare and no report of an infection will be generated. Even when the physician correctly diagnoses the illness and prescribes the appropriate medication, a confirmatory laboratory test may not be ordered. If ordered, the patient may not submit the sample to the laboratory, since many patients are unwilling to submit stool specimens for laboratory analysis. Since laboratories are the primary source of disease reports for surveillance systems, without a laboratoryconfirmed diagnosis, a report may never be filed. When a stool or blood sample is submitted for laboratory analysis, it can also test negative because of analytical or specimen collection error, untimely collection or because the material submitted was, by chance, free of the pathogen (Chappell et al. 1996). Laboratory proficiency can vary considerably. This may be more of a problem for laboratories that run only a small number of the ordered test. For persons infected with enteric parasites, single stools may often be free of the parasite or have insufficient numbers of parasites to assure laboratory detection. In some cases, even multiple stools may be pathogen-negative. If a sufficient number of cases of illness from the same pathogen are reported to the health department at about the same time and if the epidemiologist is alert to an increase in case reports, an outbreak may be identified. Because of the time required to perform the diagnostic tests and to report the results, outbreak recognitions may occur weeks after the onset of the actual outbreak. Many outbreaks are first detected by an alert clinician. For example, in 1976, a Camas, Washington physician’s son had returned from Russia with giardiasis. The physician later recognized that several of his patients had similar symptoms. This lead to the identification of a waterborne giardiasis outbreak (Kirner et al. 1978). As mentioned earlier, in Milwaukee, Wisconsin a pharmacist noted a dramatic increase in sales of antidiarrheal medication. In California and Arizona, diarrheal illnesses reported to health agencies by 65 campers who had visited an Arizona park initiated an investigation that implicated contaminated water as the source of an outbreak that affected 1850 people (Starko et al. 1986). The fortuitous circumstances surrounding the detection of many outbreaks raises concerns about how many medium to large outbreaks are never detected. Small outbreaks may seldom be detected, especially among travelers who consume water from noncommunity systems or who swim in multiple locations. Limitations of the current disease surveillance systems prompted a series of studies in the early 1980s to evaluate potential improvements in disease reporting and to evaluate the efficacy of active surveillance programs. A three state study of various approaches to active disease surveillance, funded by USEPA, detected no additional waterborne disease outbreaks in two states (Washington and Vermont) (Harter et al. 1985). However, in one state (Colorado) a greater than threefold increase in the number of detected waterborne outbreaks occurred (Hopkins et al. 1985). The reasons why Colorado was able to identify so many more outbreaks than either Washington State or Vermont are unclear. An intense effort was made to

2.4 EARLY DETECTION OF OUTBREAKS

31

increase disease reporting in all states and dramatic increases in reports of enteric diseases were observed in all three states. It is possible that a combination of poor quality water supplies plus an exposed tourist population, without protective immunity, may have allowed Colorado to identify more outbreaks than the other two states. In summary, active disease reporting can increase reporting of diagnosed illnesses only from providers and laboratories. All the other barriers to disease identification and reporting will still remain (Fig. 2.1). If healthcare access declines over time or, to reduce healthcare costs, physicians use fewer laboratory diagnostic services, then the number of diagnosed reportable illnesses will decline. This will occur despite the efforts of health departments to insure that most diagnosed illnesses are reported.

2.4

EARLY DETECTION OF OUTBREAKS

Should the early detection of outbreaks be the primary goal of a surveillance system, and, if so, how can it be best achieved? The occurrence of a waterborne disease outbreak is an exciting, newsworthy, and politically important event. Affected populations may experience severe illness and a large number of people may become ill. As a result of the investigation, much is often learned about the cause of major failures in water treatment or distribution. However, when the excitement has subsided, water system deficiencies have been corrected and the outbreak is officially said to be over, has the problem been solved or is disease continuing to occur but at a reduced level, below what is detectable by traditional surveillance activities? For example, a waterborne disease outbreak investigation detected major problems with the filtration system of an anonymous small community water supply. The system was, at the time of its installation, considered adequate. However, high turbidity levels were observed in treated water at the time of the outbreak, suggesting poor operation of the filtration facility. Optimization of treatment by consulting engineers allowed the plant to dramatically improve pathogen removal. This improvement reduced the number of new cases of disease, and the outbreak officially ended. However, 2 years later a serological survey of the town’s residents revealed the continued occurrence of infection by the same etiologic agent responsible for the earlier outbreak. These new data presented both philosophical and technical problems. Should all outbreaks be followed by such a survey? Is evidence of continuing infection sufficient reason for further intervention? If the serological survey were not conducted, there would be no evidence of increase risk of infection. If the plant was already optimized, what are the remaining intervention options without new filtration or disinfection technology? This scenario assumes that the continued high serological levels resulted from waterborne transmission. In fact, without a follow-up epidemiologic investigation, it is not possible to distinguish waterborne from other routes of transmission. In addition, without improved surveillance activities, we know little about the absence of symptomatic disease. Low levels of disease from exposure to waterborne microbes over a period of many years can result in a much larger health burden

32

IMPROVING WATERBORNE DISEASE SURVEILLANCE

for a community than the number of disease cases that might occur during a detected outbreak. However, exposure to some waterborne pathogens at levels that boost the immune response may prevent symptomatic illness. These concerns must all be considered when developing a surveillance system. Without clear goals and a commitment to conduct epidemiologic investigations and take appropriate actions, a better surveillance system will not improve public health. Failure to detect low levels of disease transmission may provide a false sense of security. For example, why should an outbreak such as occurred in Milwaukee not have been preceded by many smaller outbreaks? Is it possible that in each of the cities experiencing a large waterborne cryptosporidiosis outbreak, prior undetected smaller outbreaks occurred? In fact, is it possible that lower levels of waterborne Cryptosporidium infection had occurred years prior to the outbreak? At the time of the detected outbreak, a higher number of oocysts may have passed through the treatment system or a more virulent strain of the pathogen emerged. If so, relying on disease surveillance systems that can only detect large outbreaks will seldom provide public health officials and the industry early warnings of emerging new diseases. This may be equivalent to basing the science of meteorology only on the study of hurricanes. The detection of an outbreak can also affect future disease reports in an area. For example, it is possible that overreporting of symptoms consistent with the disease of interest could occur. If so, similar outbreaks may be detected in neighboring areas. Given the increased popularity of bottled water use, it is possible that the at-risk population could change following an outbreak if a significant fraction of the population discontinued drinking tapwater. Therefore, decreases in the occurrence of reported waterborne disease may not reflect better control of the contamination but a reduction in the number of exposed individuals.

2.5

ENDEMIC DISEASE

What is meant by endemic or background rates of disease and can some of this endemic disease be attributed to drinking water? Endemic level of disease is defined by the CDC as a persistent low to moderate level of disease occurrence. A persistently high level of occurrence is called hyperendemic while an irregular pattern of occurrence is called sporadic (Fig. 2.2). For most enteric infections, endemic disease results from a statistical averaging of small to moderate-sized undetected outbreaks or clusters of infection. There is little information to suggest that endemic levels of disease remain constant over time or across geographic areas, nor is there reason to believe the endemic level of disease is unimportant. Over the past century, the importance of endemic disease has become increasingly recognized. Following World War I, an attempt was made to estimate the prevalence of parasite infections in both the returning British soldiers and the British population who remained at home (Smith and Mathews 1917). To the surprise of the researchers, a high prevalence of asymptomatic infection was found among persons who had never left Britain. Later, a survey of Wise County, Virginia in 1930 revealed that half of the population carried Entamoeba histolytica and that 38% carried

2.5 ENDEMIC DISEASE

Figure 2.2

33

Epidemic versus endemic disease.

Giardia lamblia (Faust 1930). A study to determine the incidence of Cryptosporidium infection among Peace Corp workers to be sent overseas revealed that almost 30% had possibly experienced infection prior to leaving the United States. (Ungar et al. 1989). More recent work we conducted suggests that endemic rates of Cryptosporidium infection may be very high, but that rates of cryptosporidiosis may be low (Frost 1998, Frost et al. 2001). Data derived from disease surveillance systems cannot be used to compare endemic disease levels between areas or populations with different water systems. Whether observed differences in disease reports are due to the differences in the completeness of reporting or to differences in the occurrence of the disease or the infection cannot be answered, even with improved surveillance systems. In addition, it has become increasingly recognized that populations can develop protective immunity to infectious agents. If so, rates of infection may remain high while rates of illness remain low (Frost et al. 2001). The absence of disease in a population may, therefore, not mean that there is an absence of infections. Epidemiologic studies must be specifically designed and conducted to address the association of endemic disease with water system type or quality. Several epidemiologic studies have reported waterborne disease associated with public water systems in the absence of a reported waterborne outbreak. In New Zealand, the incidence of laboratory-confirmed giardiasis was found to be higher in a part of the city receiving chlorinated, unfiltered surface water compared to the part where surface water was treated by coagulation, flocculation, granular filtration, and chlorination (Frasher and Cooke 1989). In Vermont, a higher incidence of endemic giardiasis was found in municipalities using unfiltered surface water or wells than in municipalities with filtered surface water (Birkhead and Vogt 1989). A Canadian study attempted to estimate how much endemic enteric illness was due to drinking water (Payment et al. 1991). The fraction of illness attributable to drinking water was estimated by comparing rates of reports of ‘‘highly credible gastrointestinal illnesses’’ among persons drinking tapwater with rates among

34

IMPROVING WATERBORNE DISEASE SURVEILLANCE

people drinking water from reverse osmosis filtration units. Although different rates of illness could have resulted from reporting biases, if the findings are confirmed by future studies, then drinking water may significantly contribute endemic disease in at least one community. Unfortunately, a study using a similar design conducted in Melbourne, Australia, did not provide evidence of endemic waterborne disease (Hellard et al. 2001). A variety of approaches have been proposed for estimating the burden of endemic diarrheal disease from drinking water sources. In addition to the Australian replication of the Payment design, a small pilot household intervention study in California has recently been completed (Colford et al. 2001). That study concluded that it was possible to blind families as to the type of treatment device they had, and although the study was not powered to examine illness rates, the families with true home treatment devices reported a lower rate of illness. A larger randomized household intervention study is under way in the United States. The advantage of the randomized household interventions is that the design precludes reporting biases and assignment biases, assuming that people do not know whether they are in the intervention or the control group. A major disadvantage of this approach is that only household drinking water quality is altered. Drinking water from other sources, such as work or at restaurants, is not altered. Another limitation is that long-term healthy residents are usually recruited and these people may have the lowest risk of suffering illness from waterborne infections. Therefore, negative results are difficult to interpret. Household intervention studies are limited in generalizability because they are conducted in single communities, although the study design would be amenable to national randomized trial. Another proposed approach is to relate variations in the occurrence of health events, such as emergency room visits and hospitalization, with variation in drinking water turbidity levels (Schwarz et al. 1997, Morris et al. 1998). This approach has some merit; however, the results are difficult to interpret since no causal agents are identified. There are also concerns that the optimized statistical modeling cannot be statistically evaluated. Therefore, many of the claimed associations may be spurious. Another approach uses planned changes in drinking water treatment and then evaluates the occurrence of potentially waterborne disease before and after intervention. The advantage of this approach is that most or all drinking water from an area is changed. This avoids one of the problems with household interventions. One disadvantage of this approach is that the sites receiving new water treatment technologies are not randomly assigned. For example, most unfiltered drinking water systems in the United States use high-quality source water. Adding filtration may not dramatically change the health risks from the drinking water. Another is that the community intervention looks at only one city or one pair of cities, so the sample size is restricted.

2.6

APPLICABILITY OF OUTBREAK INVESTIGATIONS

Can findings from outbreak investigations be used to estimate the burden of enteric disease attributable to drinking water? Epidemic disease is defined as an unusual

2.6 APPLICABILITY OF OUTBREAK INVESTIGATIONS

35

occurrence or clustering of a specific illness. Between 1971 and 1994 there were 737 documented waterborne disease outbreaks (Craun 1992, Moore et al. 1994, Kramer et al. 1996). Almost half of these were due to unknown etiological agents that caused acute gastrointestinal illness. Among these outbreaks, the relative importance of different etiologic agents (viruses, bacteria, protozoa, and chemicals) can be estimated. For example, the etiologic agents most commonly associated with waterborne disease in the United States include, in descending order, undefined gastroenteritis, giardiasis, shigellosis, viral gastroenteritis, and hepatitis A. This ranking is based on outbreaks and may or may not reflect the relative importance of these etiologic agents for all waterborne disease. For diseases where outbreaks account for the majority of illnesses, the outbreak is of primary interest. However, for many waterborne pathogens, outbreaks account for only a small fraction of all illnesses. For example, in a 1.5-year period during the late 1970s in Washington State, 1347 laboratory confirmed cases of giardiasis were reported to the state health department (Frost et al. 1983). Extensive follow-up of these cases (Table 2.3) revealed that clusters or possible small outbreaks accounted for only 16% of all cases of giardiasis reported during this time period. These data suggest that ‘‘endemic giardiasis’’ was overwhelmingly more abundant than ‘‘epidemic giardiasis’’ in Washington State during this time period. There are a number of problems with extrapolating the characteristics of cases involved in outbreaks to revise all cases of illness, including the following: 1. If there is variation in the virulence of a pathogen, then detected outbreaks may predominantly be caused by the more virulent strains of the pathogen. This may overestimate the severe morbidity or mortality associated with the pathogen. 2. By examining only detected outbreaks, one may overestimate the importance of drinking water as a route of transmission. Because of the large number of cases often involved, waterborne outbreaks may be more detectable than TABLE 2.3 1977–1978

Case Clusters of Giardiasis in Washington State

Number of Cases 10 14 11 12 17 8 24 73 51 220

Etiology Untreated streamwater consumption Untreated water consumption at a work camp One small community water system Tourists returning from a resort in Mexico One-daycare center outbreak One-daycare center outbreak Among 10 different daycare centers Multiple cases among 21 families Nonfamily association with another case Total in all clusters

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outbreaks from other routes of transmission. Even a severe day care outbreak would involve only a few cases. Within family clusters usually involve too few cases to be a detectable outbreak. 3. Outbreak detection is often more difficult for common or endemic diseases than for uncommon diseases. For example, two cases of cholera anywhere in the United States might be considered an outbreak whereas 50 cases of cryptosporidiosis widely dispersed in a large U.S. city during a week might easily be absorbed as expected background cases of diarrhea and not recognized as an outbreak (Craun et al. 1994). Outbreaks of short duration of illnesses (e.g., some viruses) are more difficult to detect and study than are outbreaks of long duration illnesses (e.g., giardiasis, shigellosis, hepatitis A). Therefore the importance of acute, self-limited gastrointestinal illness of undetermined etiology and short duration may be underestimated relative to outbreaks of parasitic infections and some bacterial or viral pathogens with a longer duration of symptoms. Pathogens with long incubation periods are difficult to investigate since the conditions that allowed transmission of the pathogen may have changed between the time of infection and the time when the outbreak was detected. Underascertaining waterborne sources for disease outbreaks caused by these agents is likely.

2.7

MONITORING INFECTION VERSUS DISEASE

Only a fraction of infected persons become ill from the most commonly occurring enteric infections. Of the people that become ill, only a fraction of cases will be reposted (Fig. 2.3). Should expanded surveillance programs attempt to monitor infection rather than disease? The existence of asymptomatic carriers of infections has been known for some time (e.g., Typhoid Mary). However, the number of asymptomatic carriers for many infections has only relatively recently been appreciated. The parasite prevalence surveys in Britain (Smith and Matthews 1917) and in Virginia (Faust 1930) found more asymptomatic infected persons than expected. Even as late as 1952, in New Hope, Tennessee, 10.6% of the general population was infected with Giardia lamblia (Eyles et al. 1953). Following a 1966 giardiasis outbreak in Aspen, Colorado, a stool survey found that 5% of the population was infected with Giardia (Gleason et al. 1970). A survey of Boulder, Colorado, also conducted following an outbreak, found a prevalence of 5% (Wright et al. 1977). Most of the individuals participating in these surveys were asymptomatic. A stool survey of one to 3-year-old Washington State children was conducted in 1980 (Harter et al. 1982). This survey found that 7% of the children were infected with Giardia lamblia. All participating children were reported as healthy at the time of the survey. The Seattle Virus Watch program, conducted during the 1960s and early 1970s monitored virus infections among a sample of people in selected U.S. cities. This study found that illness was reported in less than half of all enterovirus infections (Elveback et al. 1966).

2.7 MONITORING INFECTION VERSUS DISEASE

Figure 2.3

37

Events in reporting an individual infection.

New serological tools have been developed since the early 1980s to better monitor the prevalence of prior infections among the population. Even though infection may not result in moderate or severe illness, there are several reasons for considering infection rather than disease, including the following: 1. Information on infections can provide a much expanded understanding of the relative importance of various routes of transmission and provide an early warning for risks of outbreaks. 2. Serological epidemiologic studies of infection can better estimate the extent of endemic waterborne disease. These studies are statistically more powerful to detect low risks in moderate-size populations. 3. Just as the occurrence of a coliform test indicates the potential of disease risk for a drinking water source, the waterborne transmission of pathogens, even when infection is predominantly asymptomatic, can provide critical information for evaluating water treatment systems and may help identify correctable problems in water source protection and=or treatment. 4. Widespread, unrecognized transmission of infection in the general population may indicate a devastating outbreak for a susceptible subpopulation.

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Another advantage of serological surveillance occurs during an outbreak. An outbreak of cryptosporidiosis was detected in Las Vegas, Nevada in Spring 1994. Although this was clearly a cryptosporidiosis outbreak, the inability to detect problems with the water treatment system and publicity prior to the investigation that suggested the outbreak was waterborne raised questions over whether the outbreak could be classified as waterborne (Craun and Frost 2002, Craun et al. 2001, Rodman et al. 1998). Since the majority of the diagnosed cases also suffered from HIV or AIDS, the extent of the outbreak was unclear. Had asymptomatic infected persons been identified serologically, the effects of reporting bias would be reduced since asymptomatic cases would have no motivation to explain an asymptomatic infection.

2.8

IMPROVING DISEASE SURVEILLANCE

Several options are available for enhanced waterborne disease surveillance. The option or combination of options selected will depend on the specific goals for disease surveillance. The currently used national system of surveillance, based on diagnosed illness, has a long-established record of both performance and nonperformance for detecting outbreaks (Table 2.4). Because the current system is both inexpensive to maintain and currently operational, it has considerable appeal among public health practitioners. However, monitoring pharmaceutical sales, nurse hotline calls, or physician visits is a potential enhancement to the traditional disease surveillance programs (Table 2.5) (Rodman et al. 1997, 1998). TABLE 2.4 Advantages and Disadvantages of the Current Waterborne Disease Surveillance System Advantages In-place and operational across the nation Extensive health department experience using the system Inexpensive to maintain An operational nationwide network, operated by the Centers for Disease Control (CDC), for summarizing and reporting findings Methodological development of algorithms for detecting excess occurrences of disease Disadvantages Inability to detect outbreaks when diagnosed cases are not reported to the health department Delays in detecting outbreaks due to the time required for laboratory testing and for reporting of findings Undetected outbreaks where health problems are not medically treated or where infection results in only mild or no illness Limited opportunities for system improvement Possible long-term trend in healthcare delivery that may reduce its efficacy

2.8 IMPROVING DISEASE SURVEILLANCE

TABLE 2.5 Systems

39

Advantages and Disadvantages of New Waterborne Surveillance

Advantages They may detect outbreaks where few patients seek healthcare or where the illness is of sufficiently short duration that healthcare is unimportant They are relatively fast in reporting outbreaks since the time delay between the onset of symptoms and the purchase of drugs or calls to nurses is likely to be short They are relatively inexpensive to maintain, especially if nationwide retail pharmacies are involved or common nurse hotline software is programmed for reporting Disadvantages Since only symptoms are ascertained, they will not usually identify an etiologic agent Although inexpensive to maintain, initial computer programming and establishing data sharing agreements would require some investment The specificity of the system for outbreak detection (e.g., number of false leads) is untested

The goal of our current disease surveillance system is outbreak detection. Unfortunately, there is little rigorous evaluation of its capability to detect outbreaks. Furthermore, the common occurrence of fortuitous situations that lead to the outbreak detection raise questions about the sensitivity of the system. To improve the sensitivity to detect small to medium-size outbreaks or to provide early information on the occurrence of an outbreak, these alternative approaches mentioned have promise. Over-the-counter pharmaceutical sales may be useful, but it has some significant limitations (Rodman et al. 1997). The use of nurse hotline calls to continuously monitor the occurrence of infectious disease has tremendous promise, but no efforts have been made to use this surveillance tool (Rodman et al. 1998). Better linkages with infectious disease specialists in healthcare organizations may also improve disease surveillance. None of the traditional or enhanced surveillance tools will provide much useful information on low-level or endemic risk of enteric pathogen infection. However, new serological tests have increased the feasibility of studies to estimate the incidence of new infections or the prevalence of antibody response to pathogens and to relate this information with modes of transmission. In the early 1970s, the Seattle Virus Watch program examined occurrences of viral infections among volunteers in selected communities (Gleason et al. 1970). Similar approaches to monitoring the occurrence of Giardia (Nulsen et al. 1994) and Cryptosporidium (Moss and Lammie 1993) infections have been developed since then. More work is needed to evaluate these new tools as well as to develop other tests. We also need to design cost-effective approaches to their widespread implementation. These tools may give us an opportunity to greatly improve our understanding of the importance of various

40

IMPROVING WATERBORNE DISEASE SURVEILLANCE

modes of transmission and identify reasons why one population group has a higher endemic level of disease than another. It is likely that as more is known about the modes of transmission, a better understanding will emerge of both drinking water and nondrinking water routes of pathogen transmission. Healthcare reforms may reduce the use of diagnostic laboratory services, reducing the value of laboratory-based disease surveillance. However, new opportunities for improved disease surveillance, including both individual and community disease reporting and surveillance of endemic infections, may also result. To fully exploit these opportunities, a new public health partnership with distributed responsibilities may be needed between healthcare providers, health maintenance organizations (HMOs), pharmacies, and the traditional public health agencies. The increasing age of our population has resulted in increases in the number of immunosuppressed persons. Some of this immunosuppression may result from chronic diseases, while some may result from medically induced immunosuppression following treatment for other conditions. For example, many cancer patients have temporary periods of immunosuppression following treatment. These populations may be at especially high risk of adverse consequences of infection. Since diarrheal disease in this population is also relatively common, many infections may not be detected. Infectious disease surveillance systems are operated by state and local public health agencies with little or no direct contact with healthcare providers. To improve disease surveillance system, it will likely be necessary to better integrate healthcare delivery systems with those disease surveillance programs. This integration can only occur if both the state public health agencies and the healthcare providers recognize benefits from this cooperation and barriers to data sharing are reduced.

REFERENCES Bennett J. V., S. D. Holmberg, and M. F. Rogers. 1987. Infectious and parasitic diseases. Closing the Gap: The Burden of Unneccessary Illness. Edited by R. W. Amler and H. B. Dull. New York: Oxford University Press. Berkelman, R. L., R. T. Bryan, M. T. Osterholm, J. W. LeDuc, and J. M. Hughes. 1994. Infectious disease surveillance: A crumbling foundation. Science 264:368–370. Birkhead, G. and R. L. Vogt. 1989. Epidemiologic surveillance for endemic Giardia lamblia infection in Vermont. Am. J. Epidemiol. 129:762–768. Chappell, C. L., P. C. Okhuysen, C. R. Sterling, and H. L. DuPont. 1996. Cryptosporidium parvum: Intensity of infection and oocyst excretion patterns in healthy volunteers. J. Infect. Diseases 173:232–236. Colford, J. M., J. R. Rees, T. J. Wade, A. Khalakdina, J. F. Hilton, I. J. Ergas, S. Burns, A. Benker, C. Ma, C. Bowen, D. C. Mills, D. J. Vugia, D. D. Juranek, and D. A. Levy. 2001. Participant blinding and gastroinntestinal illness in a randomized, controlled trial of an in-home drinking water intervention. Emerging Infect. Diseases 8(1):29–36. Chorba, T. L., R. L. Berkelman, S. K. Safford, N. P. Gibbs and P. E. Hull. 1989. Mandatory reporting of infectious diseases by clinicians. J. Am. Med. Assoc. 262:3018–3026.

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41

Craun, G. F. 1992. Waterborne disease outbreaks in the United States of America: Causes and prevention. World Health Statistics Quart. 45:192–196. Craun, C. L., G. Birkhead, S. Erlandsen, et al. 1994. Report of New York City’s Advisory Panel on Waterborne Disease Assessment. New York: The New York City Department of Environmental Protection. Craun, G. F., F. J. Frost, R. L. Calderon, H. Hilborne, K. R. Fox, D. J. Reasoner, C. Poole, D. J. Rexing, S. A. Hubbs, and A. P. Dufour. 2001. Improving waterborne disease outbreak investigations. Int. J. Environ. Health Research, 11:229–243. Craun, G. F. and F. J. Frost. 2002. Possible information bias in a waterborne outbreak investigation. Int. J. Environ. Health Research, 12:5–15. D’Antonio, R. G., R. E. Winn, J. P. Taylor, T. L. Gustafson, G. W. Gray, W. L. Current, R. A. Zajac and M. M. Rhodes. 1985. A waterborne outbreak of cryptosporidiosis in normal hosts. Annals Int. Med. 103:886–888. Elveback, L. R., J. P. Fox, A. Ketler, C. D. Brandt, F. E. Wassermann, and C. E. Hall. 1966. The Virus Watch program; a continuing surveillance of viral infections in metropolitan New York families. 3. Preliminary report on association of infections with disease. Am. J. Epidemiol. 83:436–454. Eyles, D. E., F. E. Jones, and S. C. Smith. 1953. A study of Entamoeba histolytica and other intestinal parasites in a rural west Tennessee community. Am. J. Trop. Med. 2:173–190. Faust, E. C. 1930. A study of the intestinal protozoa of a representative sampling of the population of Wise County, southwestern Virginia. Am. J. Hygiene 11:371–384. Foster, L. R. 1990. Surveillance for waterborne illness and disease reporting: State and local responsibilities. In Methods for Investigation and Prevention of Waterborne Disease Outbreaks, G. F. Craun, ed. EPA=600=1-90=005a. Cincinnati: USEPA Office of Research and Development. Frasher, G. G. and K. R. Cooke. 1989. Endemic giardiasis and municipal water supply. Am. J. Public Health 79:39–41. Frost, F. 1998. Two-city Cryptosporidium study. Am. Water Works Assoc. Research Found.— Drink. Water Research 8(6):2–5. Frost, F. J., R. L. Calderon, R. L., and G. L. Craun. 1995. Waterborne disease surveillance: Findings of a survey of state and territorial epidemiology programs. J. Environ. Health. 58(5):6–11. Frost, F., L. Harter, B. Plan, K. Fukutaki, and B. Holman. 1983. Giardiasis in Washington State. USEPA Report 83-134-882. Springfield, VA: National Technical Information Service. Frost, F. J., T. Muller, G. F. Craun, R. L. Calderon, and P. A. Roeffer. 2001. Paired city Cryptosporidium serosurvey in the southwest USA. Epidemiol. Infect. 126:301–307. Frost F. J., T. Muller, G. F. Craun, D. Fraser, D. Thompson, R. Notenboom, and R. L. Calderon. 2000. Serological analysis of a cryptosporidiosis epidemic. Internatl. J. Epidemiol. 29:376–379. Gleason N. N., M. S. Horwitz, L. H. Newton, and G. T. Moore. 1970. A stool survey for enteric organisms in Aspen, Colorado. Am. J. Trop. Med. Hygiene 19:480–484. Harter, L., F. Frost, and W. Jakubowski. 1982. Giardia Prevalence among 1-to-3 year-old children in two Washington State counties. Am. J. Public Health 72:386–388. Harter, L., F. Frost, R. Vogt, A. Little, R. Hopkins, B. Gaspard, and E. Lippy. 1985. A threestate study of waterborne disease surveillance techniques. Am. J. Public Health 75: 1327–1328.

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Hayes, E. P., T. D. Matte, T. R. O’Brien, T. W. McKinley, G. S. Logsdon, J. B. Rose, B. L. P. Ungar, D. M. Word, P. F. Pinksky, M. L. Cummings, M. A. Wilson, E. G. Long, E. S. Hurwitz, and D. D. Jaranek. 1989. Large community outbreak of cryptosporidiosis due to contamination of a filtered public water supply. New Engl. J. Med. 320:372–376. Hellard, M. E., M. I. Sinclair, A. B. Forbes, and C. K. Fairley. 2001. A randomized blinded controlled trial investigating the gastrointestinal health effects of drinking water quality. Environ. Health Perspect. 109:773–778. Hopkins, R. S., P. Shillam, B. Gaspard, L. Eisnach and R. S. Karlin. 1985. Waterborne disease in Colorado: three years surveillance and 18 waterborne outbreaks. Am. J. Public Health 75:254–257. Kirner, J. C., J. D. Littler, and L. A. Angelo. 1978. A waterborne outbreak of giardiasis in Camas. J. Am. Water Works Assoc. 70:35–40. Kramer, M. H., B. L. Herwaldt, G. F. Craun, R. L. Calderon, and D. D. Juranek. 1996. Surveillance for waterborne disease outbreaks—United States, 1993–1994. J. Am. Water Works Assoc. 88:66–80. Leland, D., J. McAnulty, W. Keene, and G. Terens. 1993. A cryptosporidiosis outbreak in a filtered water supply. J. Am. Water Works Assoc. 85:34–42. MacKenzie, W. R., N. J. Hoxie, M. E. Proctor, M. S. Gradus, K. A. Blair, D. E. Peterson, S. S. Kazmierczak, D. G. Addiss, K. R. Fox, J. B. Rose, and J. P. David. 1994. A massive outbreak in Milwaukee of Cryptosporidium infection transmitted through the public drinking water supply. New Engl. J. Med. 331(3):161–167. Moore, A. C., B. L. Herwaldt, G. F. Craun, R. L. Calderon, A. K. Highsmith, and D. D. Juranek. 1994. Waterborne disease in the United States, 1991 and 1992. J. Am. Water Works Assoc. 84(2):87–99. Morris, R. D. F., E. N. Naumova, and J. K. Griffiths. 1998. Did Milwaukee experience waterborne cryptosporidiosis before the large documented outbreak in 1993? Epidemiology 9:264–270. Moss, D. M. and P. J. Lammie. 1993. J. Am. Soc. Trop. Med. Hygiene 49:393. Nulsen, M. F., P. G. Tilley, L. Lewis, H. Z. Zhang and J. L. Isaac-Renton. 1994. The humeral and cellular host immune responses in an outbreak of giardiasis. Immunol. Infect. Diseases 4:100–105. Payment, P., L. Richardson, J. Siemiatycki, et al. 1991. A randomized trial to evaluate the risk of gastrointestinal disease due to consumption of drinking water meeting current microbiologic standards. Am. J. Public Health 81(6):703–708. Rodman, J. S., F. Frost, I. D. Burchat, D. Fraser, J. Langer, and W. Jakubowski. 1997. Pharmacy sales—a method of disease surveillance. J. Environ. Health 60(4):8–14. Rodman, J. S., F. J. Frost, and W. Jakubowski. 1998. Using nurse hot line calls for disease surveillance. Emerg. Infect. Diseases 4:1–4. Schwarz, J., R. Levin, and K. Hodge. 1997. Drinking water turbidity and pediatric hospital use for gastrointestinal illness in Philadelphia. Epidemiology 8:615–620. Smith, A. M. and J. R. Matthews. 1917. The intestinal protozoa of non-dysenteric cases. Annals Trop. Med. Parasitol. 10:361–390. Starko, K. M., E. C. Lippy, L. B. Dominguez, C. E. Haley and H. J. Fisher. 1986. Campers’ diarrhea traced to water-sewage link. Public Health Reports 101:527–531.

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Ungar, B. L., M. Milligan, and T. B. Nutman. 1989. Serologic evidence of Cryptosporidium infection in U.S. volunteers before and during Peace Corps service in Africa. Arch. Int. Med. 149:894–897. Wright, R. A., H. C. Spender, R. E. Brodsky, and T. M. Vernon. 1977. Giardiasis in Colorado: An epidemiologic study. Am. J. Epidemiol. 105:330–336.

3 WATERBORNE OUTBREAKS IN THE UNITED STATES, 1971–2000 GUNTHER F. CRAUN, P.E., M.P.H., D.E.E. Gunther F. Craun & Associates, Staunton, Virginia

REBECCA L. CALDERON, Ph.D. U.S. Environmental Protection Agency, National Health and Environmental Effects Research Laboratory, Research Triangle Park, North Carolina

MICHAEL F. CRAUN, P.E., M.S. Gunther F. Craun & Associates, Staunton, Virginia

3.1

INTRODUCTION

In this chapter, the causes of 1010 waterborne outbreaks reported in the United States during the period 1971 to 2000 are reviewed. Most (74%) of the outbreaks were associated with contaminated drinking water; 648 outbreaks were reported in public drinking water systems, and 103 were reported in individual water systems. An additional 259 (26%) outbreaks were associated with water recreation, primarily swimming. Disclaimer: The views expressed in this article are those of the individual authors and do not necessarily reflect the views and policies of the USEPA. The article has been subject to the Agency’s peer and administrative review and approved for publication. Drinking Water Regulation and Health, Edited by Frederick W. Pontius. ISBN 0-471-41554-5 # 2003 John Wiley & Sons, Inc.

45

46

3.2

WATERBORNE OUTBREAKS IN THE UNITED STATES, 1971–2000

WATERBORNE DISEASE OUTBREAK SURVEILLANCE SYSTEM

National statistics on waterborne outbreaks have been reported in the United States since 1920. In 1971, the Centers for Disease Control and Prevention (CDC), the U.S. Environmental Protection Agency (USEPA), and the Council of State and Territorial Epidemiologists began a collaborative surveillance program for the collection and reporting of data on the occurrence and causes of waterborne outbreaks (Lee et al. 2002, Barwick et al. 2000, Levy et al. 1998, Kramer et al. 1996, Moore et al. 1993, Herwaldt et al. 1993, Craun 1990). Each year, state and territorial epidemiologists or persons designated as waterborne outbreak surveillance coordinators voluntarily report information about waterborne outbreaks to the CDC and USEPA. The surveillance system records information about the epidemiology of the outbreak, etiologic agents, types of water system, system deficiencies, water sources, and water quality. These surveillance data are useful for evaluating the relative degrees of risk associated with different types of source water and systems and the adequacy of current technologies and regulations. To be defined as a waterborne outbreak, at least two persons must have experienced a similar illness after the ingestion of drinking water or after exposure to water used for recreational purposes, and epidemiologic evidence must implicate water as the probable source of the illness. The exceptions are single case outbreaks of chemical poisoning (e.g., methemoglobinemia), if water-quality data indicate contamination by the chemical, and single case outbreaks of laboratory-confirmed, primary amebic meningoencephalitis. Waterborne outbreaks are classified according to the strength of the epidemiological evidence implicating water and the available information about water quality, sources of contamination, and system deficiencies. Epidemiological information is weighted more heavily than information about water quality or the water system. The circumstances of each outbreak investigation differ. Not all outbreaks are rigorously investigated, and information is often incomplete. Even when adequate information is available to classify the outbreak, the investigation may not have been optimal in terms of an epidemiological, engineering, or water quality evaluation. Water samples are usually collected for bacteriological or chemical contaminants, but in only a few outbreak investigations are attempts made to isolate a pathogen from water samples. Most reported outbreaks were associated with water used or intended for drinking or domestic purposes, but outbreaks were also associated with the ingestion of water not intended for consumption (e.g. the use of springs and creeks by backpackers and campers, and accidental ingestion of water while swimming, diving, or other waterassociated recreation). Recreational waters encompass swimming pools, water parks, interactive play fountains, wading pools, and naturally occurring fresh and marine surface waters. Although the surveillance system records whirlpool- and hot tubassociated outbreaks of dermatitis, these outbreaks are not included in the analysis presented here. The surveillance system collects information about but does not record waterborne outbreaks caused by contamination of water or ice at its point of use (e.g., a contaminated water faucet or serving container). Outbreaks caused by contaminated ice, faucets, and containers are included in the analysis. Point-of-use

3.2 WATERBORNE DISEASE OUTBREAK SURVEILLANCE SYSTEM

47

outbreaks, along with outbreaks caused by consumption of water not intended for drinking, are classified under miscellaneous causes. Although waterborne outbreak surveillance data are useful for evaluating the adequacy of approaches for providing safe drinking and recreational water, the data underestimate the true incidence of waterborne outbreaks. Not all outbreaks are recognized, investigated, and reported to the CDC or USEPA, and the extent to which these outbreaks are not recognized and not reported is largely unknown. The likelihood that individual cases of illness will be detected and epidemiologically associated with water is dependent on many factors including a) public awareness, b) the likelihood that persons who are ill will consult the same rather than different health-care providers, c) availability and extent of laboratory testing, d) local requirements for reporting cases of particular diseases, and e) the surveillance and investigative activities of state and local public health and environmental agencies. The states that report the most outbreaks during any single year might not be those where the most outbreaks occur. Outbreaks of acute illness characterized by a short incubation period are more readily identified. Outbreaks involving serious illness are most likely to receive the attention of health authorities and to be investigated. Outbreaks associated with community water systems are more likely to be recognized than those associated with non-community systems because the latter serve mostly nonresidential areas and transient populations. Outbreaks associated with individual systems are the least likely to be recognized and reported because they generally involve few persons. Recreational water and non-community outbreaks that result from persons congregating in one venue then dispersing are often difficult to recognize and investigate. Each water system associated with a waterborne outbreak was classified as a public or individual system and as having one of the following deficiencies: untreated surface water; untreated groundwater; treatment deficiency (e.g., temporary interruption of disinfection, inadequate disinfection, and inadequate or no filtration); distribution system deficiency (e.g., cross-connection, contamination of water mains during construction or repair, and contamination of a storage facility); and unknown or miscellaneous deficiency (e.g., contaminated ice, faucets, containers, or bottled water). Water sources were identified as either surface water, groundwater, or mixed (both surface water and groundwater sources). Water not intended for drinking was classified as an individual water system, since the person consuming the water chose to drink from these sources. Although non-community systems were not classified as transient or non-transient, most of these systems primarily served visitors and would be considered non-transient. In outbreaks associated with water used for recreation, information was collected about the venue, suspected source of contamination, and factors that may have contributed to the outbreak. State and local health departments and other agencies have jurisdiction over recreational waters, including public swimming and wading pools. The USEPA has established a guideline (monthly geometric mean must be
33=100 mL for enterococci or
126=100 mL for Escherichia coli.) for microbial water quality of fresh waters (e.g., lakes, ponds) used for recreational activities (Lee et al. 2002, Dufour 1984, Cabelli 1983). However, states and localities can have

48

WATERBORNE OUTBREAKS IN THE UNITED STATES, 1971–2000

either more or less stringent guidelines or regulations and can post warning signs to alert potential bathers until water quality improves. The CDC recently cautioned consumers about health risks associated with swimming and wading pools and how to reduce these risks (CDC 2001).

3.3 3.3.1

WATERBORNE OUTBREAK STATISTICS Type of Water System

During the 30-year period 1971–2000, 308 outbreaks and 517,944 illnesses were reported in community water systems; 340 outbreaks and 54,893 illnesses were reported in non-community systems (Table 3.1). An estimated 21,740 persons became ill during 259 outbreaks associated with water recreation; 103 outbreaks and 1600 cases of illness were reported in individual water systems. In the United States, public water systems are classified as either community or non-community and are regulated by the USEPA. A community water system serves year-round residents of a community, subdivision, or mobile-home park that has 15 or more service connections or an average of 25 or more residents. A non-community water system is used by the general public for greater than 60 or more days per year and at least 15 service connections or serves an average of 25 or more persons. Non-community water systems are also classified as non-transient and transient. Non-transient systems (e.g., in factories and schools with their own water systems) serve 25 or more persons for at least six months of the year. Transient non-community water systems do not serve at least 25 of the same persons over six months per year (e.g., many restaurants, rest stops, parks). Individual water systems, which are not owned or operated by a water utility and serve less than 15 connections or less than 25 persons, are not regulated by the USEPA; each state or county develops regulations for these systems. The reporting of waterborne outbreaks varied considerably during the 30-year period (Figure 3.1). More outbreaks (n ¼ 220) were reported during the five-year period of 1976–80 than during any other 5-year period. The largest number (n ¼ 90) TABLE 3.1 Waterborne Outbreaks Reported in the United States by Type of System or Activity, 1971–2000 Water System Type Non-Community Community Recreational Individual All Water Systems

Outbreaks

Cases of Illness

Emergency Room Visits

Hospitalizations

Deaths

340 308 259 103 1010

54,893 517,944 21,740 1600 596,177

116 904 36 5 1061

868 1056 206 93 2223

4 65 28 3 100

3.3 WATERBORNE OUTBREAK STATISTICS

49

Figure 3.1 Waterborne outbreaks reported in the United States by type of water system or water recreation, 1971–2000. I ¼ individual water system; NC ¼ non-community water system; C ¼ community water system; R ¼ recreation water.

of community system outbreaks was reported during 1981–85, and the smallest number (n ¼ 24) was reported during 1996–2000. Slightly more than half (56%) of the outbreaks in community systems and almost half (46%) of the outbreaks in non-community systems were reported during the ten-year period 1976–85. Most (62%) of the outbreaks associated with recreational water have been reported since 1991. Apparent trends in the occurrence of outbreaks are most likely due to differences in the recognition, investigation, and reporting by public health agencies during the 30-year period. Because of recent publicity about waterborne pathogens such as Cryptosporidium and E. coli 0157:H7, both the public and health officials are more aware of the potential for an outbreak when persons suffer gastrointestinal symptoms, especially during or after swimming. The magnitude of waterborne illness reported in outbreaks varied considerably during the 30-year period (Figure 3.2). In community water systems, outbreaks resulted in as few as 59 illnesses in 1997 to as many as 404,013 illnesses in 1993. In 1997, three community outbreaks caused an average of 20 illnesses, but a single outbreak of cryptosporidiosis in Milwaukee (MacKenzie et al. 1994) was responsible for 403,000 illnesses in 1993. This is the largest number of illnesses reported in a single outbreak since the collection of waterborne outbreak statistics began in 1920. During each of the five-year periods through 1995, more than 10,000 illnesses were reported in community systems. In 1980, 18,958 illnesses were reported in 26 community system outbreaks. In 1991, and 1987, two and eight outbreaks in community systems caused 10,049 and 16,922 illnesses. During each of the five-year periods through 1995, more than 5000 illnesses were reported in non-community systems; in each of two five-year periods (1981–85, 1986–90), more than 10,000 illnesses were reported. In 1983, 12,007 illnesses were reported

50

WATERBORNE OUTBREAKS IN THE UNITED STATES, 1971–2000

Figure 3.2 Cases of illness reported in drinking water and water recreational outbreaks, 1971–2000.

3.3 WATERBORNE OUTBREAK STATISTICS

51

in nine non-community system outbreaks, and in 1998 only one outbreak of four illnesses was reported. The mean and median numbers of illness reported in community system outbreaks during the 30-year period were 17,265 and 1979, respectively compared to a mean of 1830 and median of 1316 illnesses in non-community systems. The large mean for community system outbreaks is due primarily to the Milwaukee outbreak. On average, each community system outbreak caused 1682 illnesses; however, if the Milwaukee outbreak is excluded, this statistic is reduced to 373 illnesses per outbreak. Outbreaks in non-community and individual systems each caused, on average, 161 and 16 illnesses per outbreak. Outbreaks in individual water systems were generally small; however, during four of the five-year periods, more than 200 illnesses were reported. Outbreaks in individual water systems resulted in a mean of 53 and median of 33 illnesses. Almost one-fourth of the illnesses in individual systems were reported in 2000. In outbreaks associated with recreation water, most cases of illness were reported during 1991–2000; almost half (49%) of the illnesses occurred during the three years 1994, 1995, and 1996. Water recreation was responsible, on average, for 84 illnesses per outbreak. As anticipated, outbreaks associated with recreation water occurred primarily in the summer months; 90% of the outbreaks occurred during June, July, and August (Figure 3.3). Most (71%) outbreaks in non-community systems occurred from May through September. Outbreaks in individual water systems occurred primarily (61%) from June to September. It is not certain whether outbreaks in individual systems were associated with increased water contamination during the late spring and summer months or increased exposures during these months. A recent paper suggested precipitation events might contribute to the increased risk of outbreaks (Rose et al. 2000). Increased exposures for more susceptible persons are probably an important factor for the large number of outbreaks in non-community systems, whereas in individual systems, the increased potential for water contamination is probably more important. Although fewer outbreaks were reported during the months of February and December, no seasonal distribution was apparent for outbreaks in community system.

3.3.2

Type of Water Source

A disproportionate percentage of outbreaks were reported in public water systems that use surface water sources. Although only slightly more than 13,000 (8%) public water systems use surface water sources, 186 (29%) outbreaks were reported in these systems (Table 3.2). Over 156,000 (92%) systems rely primarily on ground water sources; 402 (62%) of the outbreaks in public systems were associated with ground water sources. A water source was not identified for 53 outbreaks in non-community and community systems, and in seven systems, both surface and ground water sources were used. In recreation water outbreaks, most outbreaks occurred in surface water sources. Of the 259 outbreaks reported, 126 (63%) were associated with recreational activities in lakes, ponds, rivers, and streams; 104 (40%) were associated with swimming and wading pools (Table 3.3).

52

WATERBORNE OUTBREAKS IN THE UNITED STATES, 1971–2000

Figure 3.3

Seasonal distribution of waterborne outbreaks, 1971–2000.

3.3 WATERBORNE OUTBREAK STATISTICS

53

TABLE 3.2 Waterborne Outbreaks in Drinking Water Systems by Type of System and Water Source, 1971–2000 Number of Outbreaks

Water Source Ground Watera Surface Waterb Mixed Unknown Totals a b

Community Systems

Non-Community Systems

Individual Systems

All Systems

130 142 6 30 308

272 44 1 23 340

65 23 1 14 103

467 209 8 67 751

Surface water ¼ lakes, reservoirs, rivers, streams. Ground water ¼ wells and springs.

3.3.3

Outbreak Etiologies

Ninety-one (9%) outbreaks and 4517 ( < 1%) cases of illness were classified as acute chemical poisoning while a bacterial, viral, or protozoan etiology was identified in 513 (51%) outbreaks and 505,189 (85%) cases of illness (Tables 3.4, 3.5). In 405 (40%) outbreaks and 86,457 (14%) cases of illness, an infectious etiologic agent was suspected but not identified. Illnesses associated with drinking water outbreaks included acute gastroenteritis due to a wide variety of pathogens, typhoid fever, hepatitis, and cholera. Illnesses associated with recreational water outbreaks included acute gastroenteritis, dermatitis, primary amebic meningoencephalitis, leptospirosis, otitis externa, pharyngitis, typhoid fever, and hepatitis. In community systems, most outbreaks were caused by protozoa (31%) and undetermined etiologic agents (32%). Chemical contaminants caused 18% and bacterial agents caused 13% of the outbreaks in community systems. Most (67%) outbreaks in non-community systems were classified as acute gastroenteritis of TABLE 3.3 Waterborne Outbreaks Associated with Water Recreation Activities, 1971–2000 Water Source Lakes, Ponds Swimming and Wading Pools Othera Rivers, Streams Springs Water Slides and Wave Pools Interactive Water Fountains Unknown Totals a

Number of Outbreaks 116 104 14 10 7 4 3 1 259

Canals, puddles, ocean, dunking booth at fair, waste water holding pond, and mixed sources.

54

WATERBORNE OUTBREAKS IN THE UNITED STATES, 1971–2000

TABLE 3.4

Waterborne Outbreaks by Type of Etiology, 1971–2000 Number of Outbreaks of Specified Etiology

Water System Type

Unidentified Agents

Protozoa

Viruses

Bacteria

Chemical

Non-Community Community Recreationala Individual All Water Systems

228 98 40 39 405

31 96 97 16 240

27 20 18 9 74

43 40 97 18 198

11 54 5 21 91

a

One outbreak attributed to algae and one outbreak attributed to bacteria and protozoa not included in table.

undetermined etiology. Bacterial agents caused most of the remaining non-community system outbreaks. Protozoan and bacterial agents caused most (75%) outbreaks associated with water recreation. Recognizing that any observed trends may be due to reporting differences and other reasons (e.g., availability of laboratory facilities), the etiologies of waterborne outbreaks were examined during the 30-year period (Figure 3.4). Fewer outbreaks of acute gastroenteritis of unknown etiology and viral etiology are now being reported. An etiologic agent was identified in 76% of all outbreaks reported during 1996–2000, but in the previous 25-year period, an etiologic agent was identified in only 57% of the outbreaks. Protozoan and bacterial agents caused 60% of the outbreaks reported during 1991–2000 but only 36% of the outbreaks reported during 1971–1990. In the late 1970s and early 1980s, Giardia was an important waterborne protozoan. Although Giardia continues to cause outbreaks, Cryptosporidium was the more important waterborne protozoan in the 1990s. A viral agent was identified in 9% of the outbreaks reported during 1971–1990 but only 5% of outbreaks reported during 1991–2000.

TABLE 3.5

Cases of Waterborne Illness by Type of Etiology, 1971–2000 Cases of Illness in Outbreaks of Specified Etiology

Water System Type

Unidentified Agents

Protozoa

Viruses

Bacteria

Chemical

Community Non-Community Recreationala Individual All Water Systems

48,320 34,371 2966 800 86,457

445,882 3907 12,701 136 462,626

5435 10,076 1433 247 17,191

14,633 5830 4548 323 25,334

3674 709 40 94 4517

a One outbreak attributed to algae (14 cases) and one outbreak attributed to bacteria and protozoa (38 cases) not included in table.

3.4 CAUSES OF OUTBREAKS IN DRINKING WATER SYSTEMS

55

Figure 3.4 Trend in identifying etiologic agents in waterborne outbreaks, 1971–2000. AGI ¼ acute gastroenteritis of undetermined etiology. One recreational outbreak attributed to algae (1981) and one recreational outbreak attributed to both bacteria and protozoa (1999) were excluded from the analysis.

3.3.4

Severity of Illness

The severity of illness also varied during the 30-year period. Although information was not always available about hospitalizations or emergency room treatment, illness was severe enough in 239 outbreaks for 2223 persons to be admitted to the hospital. Various etiological agents were responsible for the hospitalizations; bacterial agents were identified for almost half (46%) of the hospitalizations (Figure 3.5). In 21 outbreaks, an additional 1061 persons were treated in a hospital emergency room. One hundred deaths were associated with the reported outbreaks; most (83%) were associated with outbreaks in community system or recreational waters (Table 3.1). In Milwaukee, it was estimated that 50 deaths were associated with the cryptosporidiosis outbreak. Twenty-seven persons died from primary amebic meningoencephalitis after becoming infected with Naegleria fowleri while swimming or diving. Sixteen deaths were associated with bacterial infections, and six deaths were attributed to acute chemical poisoning.

3.4 3.4.1

CAUSES OF OUTBREAKS IN DRINKING WATER SYSTEMS Etiology of Drinking Water Outbreaks

Giardia was the most frequently identified etiologic agent for outbreaks reported in public water systems (Table 3.6). Giardia was responsible for 83 (27%) of the outbreaks in community systems and 29 (9%) of the outbreaks in non-community

56

WATERBORNE OUTBREAKS IN THE UNITED STATES, 1971–2000

Figure 3.5 Hospitalizations in waterborne outbreaks by etiologic agent, 1971–2000. AGI ¼ acute gastroenteritis of undermined etiology. One recreational outbreak attributed to both bacteria and protozoa (4 hospitalizations) was excluded from the analysis.

TABLE 3.6 1971–2000

Etiology of Waterborne Outbreaks by Type of Drinking Water System,

Community Water Systems Etiologic Agent Undetermined Giardia Chemical Shigella Cryptosporidium Salmonella, non-typhoid Hepatitis A virus Campylobacter Norwalk virus Escherichia coli 0157:H7 Rotavirus Salmonella, typhoid Cyclospora V. cholerae E. histolytica Yersinia Plesiomonas shigelloides Escherichia coli 06:H16 SRSV Total a

Non-Community Water Systemsa

Individual Water Systems

Outbreaks Illnesses Outbreaks Illnesses Outbreaks Illnesses 98 83 54 14 11 11 10 9 9 4 1 1 1 1 1

308

48,320 25,001 3674 5715 420,856 3044 241 5353 3433 451 1761 60 21 11 4

517,944

228 29 11 24 2 2 10 7 16 4

34,371 3329 709 3417 578 72 369 120 9637 66

39 14 21 6 2 2 8 3 1 3

800 97 94 64 39 87 217 132 30 12

1

210

3

12

1

17

1 1 1 1 339

8787 60 1000 70 54,112

1

16

103

1600

One outbreak of Escherichia coli and Campylobacter with 781 cases is not included in this table.

3.4 CAUSES OF OUTBREAKS IN DRINKING WATER SYSTEMS

57

systems. Shigella, Hepatitis A, non-typhoid Salmonella, Norwalk-like viruses, Campylobacter, and Cryptosporidium were identified as etiologic agents in 64 (21%) community system outbreaks. Shigella, Hepatitis A, Norwalk-like viruses, and Campylobacter were identified in 57 (17%) outbreaks in non-community systems. In individual systems, Giardia was the second most frequently (14%) identified etiologic agent causing outbreaks; Shigella and Hepatitis A were also important etiologic agents. Chemical contaminants caused 20% of the outbreaks in individual systems and 18% of the outbreaks in community water systems. Acute chemical poisonings were caused by arsenic, benzene, chlordane, chlorine, chromium, copper, ethyl acrylate, ethylene glycol, fluoride, gasoline, hydroquinone, lead, morpholine, nitrate=nitrite, oil, polychlorinated biphenyls, phenol, selenium, liquid soap, sodium hydroxide, sodium metaborate, trichloroethylene, and unidentified herbicides. Nineteen chemical poisonings were reported in community water systems during 1991–2000. High levels of copper caused eight outbreaks, and high levels of fluoride caused three outbreaks. The remaining outbreaks were caused by nitrite, chlorine, sodium hydroxide, sodium metaborate, and liquid soap. Five outbreaks of gastroenteritis were reported in Wisconsin where high copper levels were found in new and remodeled homes with copper pipe (Levy et al. 1998, Kramer et al. 1996). In Pennsylvania, elevated copper levels in a hotel were associated with at least 43 illnesses (Kramer et al. 1996). In two other outbreaks, improper wiring and plumbing caused the leaching of copper from restaurant pipes, and a defective check value and power outage at the water treatment facility led to the release of high levels of sulfuric acid which caused corrosion and leaching of copper (Barwick et al. 2000). A large outbreak of acute fluoride poisoning in 262 persons and was attributed to improperly installed equipment and inadequate monitoring which resulted in excessive fluoride levels (Moore et al. 1993). In two other outbreaks, excessive levels of fluoride were siphoned into the system due to inadequate controls at the feed pump and due to a cross-connection; fluoride levels of 200–220 mg=L were measured in these outbreaks (Kramer et al. 1996). Thirty persons developed chemical burns in their mouths after they drank water contaminated with sodium hydroxide accidentally released from a surface water treatment plant (Levy et al. 1998). In a similar outbreak, lack of a check valve allowed approximately 200 gallons of sodium hydroxide to spill into a community well over a period of several hours (Lee et al. 2002). Although some 100–1000 persons may have been exposed, only two persons reported illness. In Florida, one person became ill after drinking water obtained from a drive-through window of a restaurant; median chlorine levels were 4.5 mg=L (Levy et al. 1998). The source of the high chlorine levels was not determined. In two outbreaks of nitrite poisoning, defective check valves for the prevention of backflow allowed chemicals used to treat water in a chilling system and a boiler to contaminate the drinking water system (Levy et al. 1998). Among employees and visitors to a hospital cafeteria, seven persons became ill 1–5 minutes after drinking a carbonated beverage (Lee et al. 2002). The investigation discovered a cross-connection in the plumbing system that might have allowed water from the cooling tower, which had been recently shock-treated with sodium metaborate, to enter the drinking water system. Sodium metaborate has been associated with nitrate

58

WATERBORNE OUTBREAKS IN THE UNITED STATES, 1971–2000

poisoning and methemoglobinemia in past incidents (Lee et al. 2002). Thirteen persons at a health-care facility developed burning in their mouths after drinking water contaminated with a concentrated liquid soap (Levy et al. 1998). Vacuum breakers to prevent backsiphonage had been incorrectly installed at soap dispensers. Since 1991, seven chemical poisonings have been reported in individual systems. Four outbreaks of methemoglobinemia were attributed to nitrate contamination of wells. In one outbreak, high levels of nitrate were found in treated well water where a reverse-osmosis membrane filter was used to reduce nitrate levels in the water source (Moore et al. 1993). Three single-case outbreaks involving infants with high blood levels were detected through a lead screening program (Herwaldt et al. 1991). Water stored at the homes of the infants was found to be corrosive, leaching lead from fittings and lead-soldered seams in the storage tanks.

3.4.2

Water System Deficiencies

Distribution system deficiencies and inadequate or interrupted disinfection of unfiltered surface water caused slightly more than half (52%) of the outbreaks in community systems (Table 3.7). Contaminants entered the distribution system through cross-connections, backsiphonage, corrosion and leaching of metals, broken or leaking mains, storage deficiencies, and construction or repair of mains. The most important chemical contaminant causing distribution-system outbreaks was copper. Outbreaks of acute illness occurred primarily as a result of corrosion in home and building plumbing systems and plumbing deficiencies in soft drink mixing machines. Microbial contaminants also entered distribution systems to cause outbreaks. Most infectious disease outbreaks were caused by unidentified pathogens; the most frequently identified pathogen in distribution system outbreaks was Giardia. In unfiltered surface water systems, disinfection was either inadequate to inactivate waterborne protozoa or interrupted so that undisinfected water was distributed. In many instances, the source water quality was such that filtration should have been provided to remove protozoan cysts and oocysts in addition to disinfection. When surface waters are filtered, however, care should be taken to ensure that facilities are adequately designed and operated. Inadequate or interrupted filtration of surface water sources was responsible for almost 10% of the outbreaks in community systems. Inadequately treated or untreated ground water caused about one-fourth of the outbreaks. The remaining outbreaks in community systems were associated with the use of untreated surface water, inadequate control of chemicals added during treatment, and miscellaneous=undetermined causes. In non-community water systems, almost three-quarters of the outbreaks were reported in ground water systems that were either not disinfected or inadequately disinfected (Table 3.7). Although fewer non-community systems use surface water sources and most non-community distribution systems are less extensive and complicated than those in community systems, outbreaks were still associated with inadequate treatment of surface water (1%) and distribution system deficiencies (7%).

59

3.4 CAUSES OF OUTBREAKS IN DRINKING WATER SYSTEMS

TABLE 3.7 2000

Waterborne Outbreaks and Deficiencies in Public Water Systems, 1971–

Community Systems Type of Contamination Distribution System Contamination Inadequate or Interrupted Disinfection; Disinfection Only Treatment, Surface Watera Inadequate or Interrupted Disinfection; Disinfection Only Treatment, Ground Water Untreated Ground Water Inadequate or Interrupted Filtration, Surface Water Miscellaneous=Unknown Inadequate Control of Chemical Feed Untreated Surface Water Inadequate or Interrupted Filtration, Ground Water Inadequate Control of Disinfection Total a

Non-Community Systems

Outbreaks

Percent

Outbreaks

96

31.2

24

7.1

64

20.8

22

6.5

42

13.6

101

29.7

34 30

11.0 9.7

140 4

41.2 1.2

21 11

6.8 3.6

32 4

9.4 1.2

6 3

1.9 1.0

13 —

3.8 —

1

0.3

—

—

340

100

308

100

Percent

Three outbreaks mixed source.

More than 71% of the outbreaks occurred in individual systems that did not provide treatment of ground or surface water sources (Table 3.8). In only two of the reported outbreaks, were the wells disinfected. It is not known how many individual systems in the United States are disinfected, but it is suspected that the few outbreaks reported in disinfected systems reflect the small number of individual systems that are disinfected. Distribution system contamination also caused outbreaks in individual systems (8%). 3.4.3

Water Quality During Outbreaks

Water quality information was reviewed for 665 known or suspected infectious disease outbreaks in public and individual water systems to determine whether coliform bacteria were detected during the outbreak investigation. In many of the investigations in public water systems, more coliform samples were collected than would be required by the Total Coliform Rule (TCR) (USEPA 1989a) for routine monitoring purposes. Water samples were collected during a relatively short period of time, often during a one to two week period. Water samples were usually collected during

60

WATERBORNE OUTBREAKS IN THE UNITED STATES, 1971–2000

TABLE 3.8 Waterborne Outbreaks and Deficiencies in Individual Water System, 1971–2000 Type of Contamination

Outbreaks

Percent

55 19 17 8 2

53.4 18.4 16.5 7.8 1.9

1 1

1.0 1.0

Untreated Groundwater Untreated Surface Water Miscellaneous=Unknown Distribution System Contamination Inadequate or Interrupted Disinfection; Disinfection Only Treatment of Ground Water Inadequate Chemical Removal Inadequate or Interruption of Filtration, Ground Water Total

103

100

the early stages of an outbreak, but in some investigations, samples were collected several weeks to a month after the beginning of the outbreak. Water samples were sometimes collected from well water sources rather than the distribution system. When such samples were obtained from undisinfected or inadequately disinfected well water systems, information from source water samples was used as a substitute for tap water samples. It was presumed that tap water samples, if they had been collected, would likely provide similar results. Information was available about the presence of coliform bacteria in the water system during the investigation of 459 (69%) outbreaks in public and individual water systems (Table 3.9). Total and=or fecal coliforms were detected during 359 (78%) of these outbreaks. Coliforms were detected during the investigation of 84% of non-community system outbreaks and 94% of individual system outbreaks but during only 65% of community system outbreaks.

TABLE 3.9 Total Coliform Data Collected During Drinking Waterborne Outbreak Investigations, 1971–2000a Number of Outbreaks

Water System Non-community Community Individual Totals a

Outbreaks of Known or Suspected Infectious Etiology 329 254 82 665

Outbreaks with Total Coliform Data 241 160 49 459

(73%) (67%) (60%) (69%)

Outbreaks where Total or Fecal Coliforms were Detected 203 110 46 359

(84) (65) (94%) (78%)

Excluded from analysis are chemical outbreaks and outbreaks associated with water recreation.

3.5 OUTBREAKS ASSOCIATED WITH RECREATIONAL WATERS

61

Water samples were collected for pathogen analysis during the investigation of 81 outbreaks. Pathogens were isolated from water samples in 72 outbreaks. Cryptosporidium and Giardia were the pathogens most frequently isolated from these water samples, however, E. coli, Shigella, Salmonella, Campylobacter, Yersinia, and enteric viruses were also isolated.

3.5

OUTBREAKS ASSOCIATED WITH RECREATIONAL WATERS

An etiologic agent was identified in most (85%) water recreation outbreaks (Table 3.10). The four most frequently identified etiologic agents in water recreation outbreaks were Cryptosporidium (15%), Pseudomonas (14%), Shigella (13%), and N. fowleri (11%). 3.5.1

Lakes

Most outbreaks were associated with swimming and bathing activities in lakes, ponds, and reservoirs, and Shigella was the most frequently (24%) identified etiology of these outbreaks. Other important illnesses associated with bathing in lakes included primary amebic meningoencephalitis caused by N. fowleri, gastroenteritis caused by E. coli 0157:H7 and Norwalk-like viruses, and Schistosoma dermatitis (swimmer’s itch). Fourteen (50%) of the twenty-eight single-case outbreaks of amebic meningoencephalitis were associated with swimming in lakes or ponds. The remaining cases were associated with swimming in rivers and canals, facial immersion in a puddle during a fight (Moore et al. 1993), and bathing in a hot spring that had been associated with two previous cases (Moore et al. 1993). N. fowleri infections are generally acquired during the summer months, when the temperature of fresh water is favorable for the multiplication of the organism. The ameba can enter a person’s body through the nasal passages when water is forced up the nose, especially during underwater swimming and diving (Barwick et al. 2000). Four outbreaks of schistosomal dermatitis were associated with swimming in Oregon lakes; in two outbreaks, geese were the suspected source of these parasites. Other outbreaks of schistosomal dermatitis occurred after swimming in lakes in California, New Jersey, Utah, and Wyoming. One swimming-associated dermatitis outbreak was associated with ocean water in Delaware where local snails were found to contain cercariae of Austrobilharzia variglandis, an avian schistosome implicated as a cause of cercarial dermatitis (Moore et al. 1993). E. coli 0157:H7 caused fifteen outbreaks, eleven (75%) of which occurred while swimming in lakes. 3.5.2

Pools

A significant number of outbreaks were associated with swimming or wading pools at various locations including community centers, parks, water theme parks, motels, country clubs, day-care centers, schools, hospitals. The three most frequently identified etiologies of outbreaks in pools were Cryptosporidium (32%), Pseudomonas

62 2243 14 77 334 252 572 404 595 40

11

7559

29 14 4 11 12 7 4

1 1

1

116

9 40 81 30 20

1 5 2 2 1

6 3 13,795

589 51

10 3

1 1 110

11,058 518 1325 65

Cases

36 9 35 4

Outbreaks

Swim Poola,b

b

Includes wading pools and pools and other activities at water parks and interactive water fountains. One outbreak of shigella and cryptosporidium (38 cases) at an interactive water fountain not included. c Includes dunking booth, natural springs, canal, ocean, unknown, and mixed sources.

a

649 2368

Cases

4 28

Outbreaks

Lakes or Pond

32

1 2 1

3 1 1 14 2 1 1 2 3

Outbreaks

348

6 11 14

80 50 21 14 18 2 30 80 22

Cases

River and Other c

40 39 36 34 28 16 15 13 10 7 5 3 3 2 2 1 1 1 1 258

Outbreaks

11,707 2966 1375 2329 28 684 387 282 661 426 40 676 70 26 11 14 11 6 3 21,702

Cases

All Recreational

Etiology of Recreational Waterborne Outbreaks, Outbreaks and Cases of Illness by Type of Water Source, 1971–2000

Cryptosporidium Undetermined Pseudomonas Shigella Naegleria Giardia Escherichia coli 0157:H7 Schistosoma Norwalk-like virus Leptospira Chemical Adenovirus Enterovirus Hepatitis A Salmonella, typhoid Microcoleus Escherichia coli 0121:H19 Campylobacter Jejuni Salmonella, non-typhoid Total

Etiologic Agent

TABLE 3.10

3.5 OUTBREAKS ASSOCIATED WITH RECREATIONAL WATERS

63

(32%), and Giardia (9%). Three pool-associated E. coli outbreaks were reported. One outbreak was associated with swimming in a poorly maintained and poorly chlorinated indoor pool, and another occurred among children using an unchlorinated wading pool where a fecal accident had occurred. In the remaining outbreak seven of 23 ill persons developed hemolytic uremic syndrome; a fecal accident in a children’s pool in the water park was suspected to be the cause. Outbreaks of chemical dermatitis or keratitis were associated with bromine, chlorine, incorrect dosing of chemicals to adjust the pH of swimming pool water, and the addition of chemicals to remove excess chloramines. An outbreak of Salmonella enterica was reported among persons using a scuba dive pool that had been filled with fish. 3.5.3

Recreational Outbreaks Reported Since 1991

Since most (62%) of these outbreaks were reported during 1991–2000, they were examined more closely. Thirty-five (90%) of the 39 outbreaks caused by Cryptosporidium since 1991 were associated with treated recreational water including swim pools, wading pools, water slides, wave pools, and interactive fountains; only four outbreaks were associated with swimming in lake water. Four of the cryptosporidiosis outbreaks and 8485 cases of illness occurred in water theme parks. One cryptosporidiosis outbreak occurred at a local zoo where 369 persons became ill after playing in a sprinkler fountain (Barwick et al. 2000). The fountain was originally designed as a decorative fountain and had become a popular interactive play area for children. Water was sprayed through the air, drained through grates, collected, passed through a sand filter, and chlorinated and recirculated. Another outbreak where illness was linked to playing in an interactive fountain was attributed to both Cryptosporidium and Shigella. The fountain’s recirculation, filtration, and disinfection systems were inadequate or not completely operational. Samples of the fountain water were positive for coliform bacteria (Lee et al. 2002). Since 1991, Shigella has caused 15 outbreaks, thirteen of which were associated with swimming in lake water. One S. sonnei outbreak was associated with a wading pool that included a sprinkler fountain. The system recirculated chlorine-treated water, and many diaper-aged children were observed sitting in the wading pool. Six of the ten outbreaks of gastroenteritis caused by Norwalk-like virus were reported during 1991–2000; three were associated with swimming in lakes and two with bathing in hot springs. Fecal coliforms were detected in the water during the investigation of the three lake outbreaks, but the source of contamination was not identified. In 1991, an outbreak of leptospirosis was associated with swimming in a rural pond in Illinois; Leptospira interrogans was found in urine specimens from cases and in pond water. The largest outbreak of leptospirosis ever reported in the United States occurred in Illinois during 1998 (Barwick et al. 2000). Among competitors in a triathlon, 375 persons became ill after swimming in a lake; 28 were hospitalized. The most recent outbreak of leptospirosis was reported among 21 persons who participated in an adventure race in Guam in July 2000. These persons reported multiple outdoor exposures, including running through jungles and savannahs,

64

WATERBORNE OUTBREAKS IN THE UNITED STATES, 1971–2000

swimming in a river and a reservoir, and bicycling and kayaking in the ocean. Leptospira was confirmed by serology, and an epidemiologic investigation demonstrated that swimming in the reservoir, submerging one’s head in the water, and swallowing water while swimming were risk factors for illness. Adenovirus serotype 3 was implicated from clinical and water samples collected in a 1991 outbreak of 595 persons with conjunctivitis, pharyngitis, and fever after swimming in a pond in North Carolina. Information was available about the source of contamination and other factors that contributed to 85 of the recreational outbreaks reported since 1991 (Table 3.11). Forty-six outbreaks were associated with pools, and 39 outbreaks were associated with untreated surface water. Multiple possible causes were noted in many of the outbreaks, and each potential source of contamination or deficiency was tabulated in Table 3.11. Poor maintenance and operation (e.g., inadequate chlorination or filtration, excessive application of pool chemicals) were identified in 23 (50%) of 46 outbreaks associated with swimming or wading pools. Fecal accidents or use of pools by diaper-age children were suspected or identified in 24 (52%) poolassociated outbreaks. Outbreaks associated with lakes, ponds, rivers, canals, and other waters used for recreational purposes were caused by a variety of problems. Fecal accidents or ill bathers were responsible for 14 (36%) of 39 untreated surface-water-associated outbreaks. Other suspected causes of surface-water outbreaks included contamination from diapers (28%), over crowding (28%), animal or bird contamination (23%), and sewage contamination of the bathing area (13%). Floodwaters contaminated a canal that was used by children for swimming in one outbreak, and heavy rains contaminated a spring in another outbreak. Fecal accidents were identified or suspected in 32 outbreaks. Fourteen (44%) of these outbreaks were caused by Cryptosporidium, six (19%) outbreaks were caused by E. coli 0157:H7, and five (16%) outbreaks were caused by Shigella. The remaining outbreaks where fecal accidents were identified were caused by an undetermined

TABLE 3.11 Causes of Waterborne Disease Outbreaks Associated with Recreational Water During 1991–2000 Source of Contamination or Deficiency Fecal Accident, Ill Bathers Poor Maintenance, Inadequate Treatment, or Operation of Swimming or Wading Pool Children in Diapers Bather Overload or Crowding Animals Seepage or Overflow of Sewage Floods a

Some outbreaks have multiple deficiencies.

Number of Outbreaks Containing Deficiencya 32 23 20 15 10 6 2

3.6 OUTBREAK TRENDS

65

infectious agent (9%), Norwalk-like virus (6%), E. coli 0121:H19 (3%), and Giardia (3%).

3.6

OUTBREAK TRENDS

Distribution system contamination was the most frequent (31%) identified cause of outbreaks reported in community systems. Unfiltered surface water and inadequate or interrupted filtration of surface water sources were responsible for 21% and 12% of the outbreaks in community systems. Inadequately treated ground water and untreated ground water caused 14% and 11% of the outbreak deficiencies. Since 1995, distribution system contamination has increased in importance as a cause of outbreaks. During 1995–2000, distribution system deficiencies caused almost half (47%) of all outbreaks reported in community water systems while unfiltered surface water caused only 3% of the outbreaks. During this same period, inadequate or interrupted filtration of surface water sources was responsible for 9% of the outbreaks in community systems, and untreated or inadequately disinfected ground water caused 9% and 18% of the outbreaks reported during 1995–2000. These statistics suggest that USEPA regulations and other actions have helped decrease the importance of unfiltered surface water systems as a cause of outbreaks. However, distribution system deficiencies as a cause of outbreaks increased in importance, and the contamination of ground water sources and inadequate operation of surface water filtration facilities continued to be important causes of outbreaks. Additional regulations and increased attention may be needed to reduce these outbreaks risks. Most distribution-system-related outbreaks were associated with cross-connections or problems with backflow prevention devices (i.e., they had not been installed, had been inappropriately installed, or inadequately maintained). Other outbreaks were caused by contaminants entering through mains and storage facilities or leaching of metals from plumbing and pipes because of corrosive water. To reduce the risk of outbreaks, increased attention should be paid to maintaining the integrity of the distribution system, reducing corrosion byproducts, and preventing contamination from cross-connections and backsiphonage, inadequately protected storage reservoirs and tanks, and the repair and construction of water mains. The maintenance of a chlorine residual throughout the system can also help protect against many sources of distribution system contamination. Frequent monitoring of chlorine residuals in the system is important as a way to detect contamination sources. Water utilities should consider a program to investigate potential distribution system contamination when chlorine residuals decline or suddenly disappear. The relative importance of inadequately filtered surface water during recent periods is similar to previous periods. The Interim Enhanced Surface Water Treatment Rule (USEPA 1998) should help reduce outbreak risks in filtered surface water systems, however, operators should also strive to maintain filtration efficacy. In non-community water systems, most of the outbreaks during the most recent period were reported in ground water systems that were inadequately protected from

66

WATERBORNE OUTBREAKS IN THE UNITED STATES, 1971–2000

sources of contamination and inadequately disinfected. Contaminated ground water also continues to be an importance cause of outbreaks in community systems. Wells and springs should be protected from surface water run-off, septic-tank effluents, and other sources of contamination, and the location of wells should consider potential sources of contamination. Periodic sanitary surveys, along with appropriate corrective measures, and a hydrogeologic assessment can help identify systems with a high possibility of fecal contamination. The location of wells should consider potential sources of contamination. The disinfection of ground water may also be required to reduce the occurrence of outbreaks, particularly for small systems where intermittent contamination of wells and springs is difficult to detect or prevent. When disinfection is provided, it must be adequate in terms of concentration and contact time based on the anticipated contamination. Disinfection must also not be interrupted. USEPA has proposed ground water requirements for sanitary surveys, disinfection of groundwater for vulnerable systems, and additional source water monitoring (USEPA 2000). Despite improved drinking water treatment for surface waters, Giardia and Cryptosporidium continue to pose waterborne risks in the United States. Cryptosporidiosis outbreaks are increasingly being reported in ground water systems. Outbreaks of giardiasis continue to be associated with both surface and ground water systems. Among the outbreaks reported in drinking water systems during 1991–1994, four (50%) of the cryptosporidiosis outbreaks and five (56%) giardiasis outbreaks were associated with ground water contamination. In 1997 and 1998, two of the three reported giardiasis outbreaks occurred in well water systems, and in 1998, both of the reported outbreaks of cryptosporidiosis were caused by sewage contamination of well water. During 1999–2000, two cryptosporidiosis and six giardiasis outbreaks were reported. One of the cryptosporidiosis outbreaks was associated with distribution system contamination; the other was caused by contamination at the point of water use. Two of the giardiasis outbreaks occurred in untreated ground water systems and two in filtered systems where filtration was by-passed. The remaining outbreaks were associated with distribution system contamination and use of water not intended for drinking. Recent outbreaks of Giardia and Cryptosporidium emphasize the importance of assessing sources of ground water contamination. Ground water sources found to be contaminated by protozoa or subject to the direct influence of surface water must meet the filtration requirements of the Surface Water Treatment Rule (SWTR) (USEPA 1989b). The continued occurrence of protozoa outbreaks in surface water systems emphasizes the importance of requiring water systems to meet USEPA’s new turbidity standards and other provisions regarding filtration efficacy (USEPA 1998). More stringent USEPA regulations for acceptable turbidity values for surface water systems have become effective since the Milwaukee outbreak in 1993 and many water utilities have conducted composite performance evaluations and corrections programs to optimize treatment plant performance to consistently achieve good removal of microorganisms and turbidity. Water contamination was documented in the majority of public water systems during the outbreak investigation. Although these statistics show that the coliform

3.6 OUTBREAK TRENDS

67

test can detect water contamination during an outbreak investigation, there are acknowledged problems with using coliform bacteria as an indicator for waterborne protozoa. Studies have suggested that the USEPA’s TCR monitoring and maximum contaminant level may not be effective in assessing the outbreak vulnerability of public water systems (Craun et al. 1997, Nwachuku et al. 2002). The number of samples required for non-community and small community systems may not be sufficient, and coliform monitoring of the distribution system alone may not be adequate to assess outbreak vulnerability. Dose-response studies have shown that relatively few organisms of Cryptosporidium, Giardia, Shigella and E. coli 0157:H7 are required to cause infection. Thus, the unintentional ingestion of a single mouthful of contaminated water while swimming and bathing could cause illness, even in non-outbreak settings (Calderon et al. 1991, Seyfried et al. 1985). Most recreational outbreaks occurred while swimming in lakes and swimming pools that were contaminated by either bather crowding, fecal accidents, or children in diapers. Swimming pool outbreaks were associated with inadequate treatment and poor maintenance and operation. Outbreaks attributed to bacteria, such as Shigella and E. coli 0157:H7, were associated primarily with swimming in fresh water (i.e., lakes, ponds, reservoirs). In contrast, most of the outbreaks caused by Cryptosporidium and Giardia were reported in chlorinated, filtered pool water. USEPA has published criteria for evaluating the quality of both marine and fresh water used for recreation (Lee et al. 2002, Dufour 1984, Cabelli 1983). Fresh and marine waters are subject to contamination not only from bathers but also from sewage discharges, watershed runoff from agricultural and residential areas, and floods. Microbial monitoring has been recommended for recreational areas potentially contaminated by sewage. Overt fecal accidents and soiled bodies can also cause fecal contamination of the water, however, the utility of routinely monitoring water for fecal contamination caused by bathers has not been established. Efforts have focused on providing adequate toilet and diaper-changing facilities at recreational areas, requiring showers before bathing, and limiting the number of bathers. Although difficult to enforce, an important measure is to prevent persons, especially young children from entering recreational waters if they are experiencing or convalescing from a diarrheal illness. Limiting the amount of water forced into the nasal passages during jumping or diving (e.g., holding the nose or wearing nose plugs) could reduce the risk for primary amebic meningoencephalitis. Cryptosporidium and Giardia are resistant to disinfection at levels generally used in swimming pools, and some pool filtration systems might not be effective in removing oocysts. Even pools with filters and disinfection practices capable of removing or killing these parasites may require hours or even a day to completely recirculate and disinfect the pool water once it becomes contaminated. Swimmers remain at risk until all of the water is recirculated through an effective water treatment process. Although the reporting of outbreaks is incomplete and the accuracy of case counts vary, waterborne outbreak surveillance data has helped identify the types of water systems, their deficiencies, and the respective etiologic agents associated

68

WATERBORNE OUTBREAKS IN THE UNITED STATES, 1971–2000

with the outbreaks. These data are important for evaluating the adequacy of current source water protection strategies, water treatment technologies and drinking and recreational water regulations and for influencing research priorities. Because the surveillance system is voluntary and does not include data for sporadic cases of disease that may be waterborne, the statistics do not reflect the true incidence of waterborne outbreaks or disease. Observed trends in the occurrence of waterborne outbreaks are likely to be a reflection of surveillance activities of local and state health agencies. Waterborne outbreaks continue to occur in the United States despite additional regulatory requirements, increased monitoring efforts, and improved water treatment facilities. These statistics provide a reminder that in this new century, waterborne problems of the previous centuries are likely to continue. New challenges remain from emerging and re-emerging pathogens that can quickly be transported with relatively ease from one part of the globe to another. Thus, vigilance and advanced preparation are needed to solve not only old problems but also anticipate new ones.

REFERENCES Barwick, R.S., D.A. Levy, G.F. Craun, M.S. Beach, and R.L. Calderon. 2000. Surveillance for waterborne-disease outbreaks—United States, 1997–1998, Morbid. Mortal. Weekly Report 49(SS-4):1. Cabelli, V.J. 1983. Health Effects Criteria for Marine Recreational Waters. EPA publication 600=1-80-031. Research Triangle Park, N.C.: USEPA. Calderon, R.L., E.W. Mood, and A.P. Dufour. 1991. Health effects of swimmers and nonpoint sources of contaminated water. Internatl. J. Environ. Health Research 1:21. CDC. 2001. Notice to readers: responding to fecal accidents in disinfected swimming venues. Morbid. Mortal. Weekly Report 50(20):416–417. Craun, G.F., ed. 1990. Methods for the Investigation and Prevention of Waterborne Disease Outbreaks. EPA 600=1-90=005a. Cincinnati, OH: USEPA. Craun, G.F., P.S. Berger, and R.L. Calderon. 1997. Coliform bacteria and waterborne disease outbreaks. J. Am. Water Works Assoc. 89(3):96. Dufour, A.P. 1984. Health Effects Criteria for Fresh Recreational Waters. EPA 600=1-84-004. Research Triangle Park, N.C.: USEPA. Herwaldt, B.L., G.F. Craun, S.L. Stokes, and D.D. Juranek. 1991. Waterborne-disease outbreaks, 1989–1990. Morbid. Mortal. Weekly Report 40(SS-3):1. Kramer, M.H., B.L. Herwaldt, G.F. Craun, R.L. Calderon, and D.D. Juranek. 1996. Surveillance for waterborne-disease outbreaks—United States, 1993–1994. Morbid. Mortal. Weekly Report 45(SS-1):1. Lee, S.H., D.A. Levy, G.F. Craun, M.J. Beach, and R.L. Calderon. 2002. Surveillance for waterborne-disease outbreaks—United States, 1999–2000. Morbid. Mortal. Weekly Report 51(SS-8):1. Levy, D.A., M.S. Bens, G.F. Craun, R.L. Calderon, and B.L. Herwaldt. 1998. Surveillance for waterborne-disease outbreaks—United States, 1995–1996. Surveillance for waterbornedisease outbreaks—United States, 1993–1994. Morbid. Mortal. Weekly Report 47(SS-5):1.

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MacKenzie, W.R., N.J. Hoxie, M.E. Proctor, M.S. Gradus, K.A. Blair, D.E. Peterson, J.J. Karmierczak, D.G. Addiss, K.R. Fox, J.B. Rose, and J.P. David. 1994. A massive outbreak in Milwaukee of Cryptosporidium infection transmitted through the public water supply. New Eng. J. Med. 331:161. Moore, A.C., B.L. Herwaldt, G.F. Craun, R.L. Calderon, A.K. Highsmith, and D.D. Juranek. 1993. Surveillance for waterborne disease outbreaks—United States, 1991–1992. Morbid. Mortal. Weekly Report 42(SS-5):1. Nwachuku, N., G.F. Craun, and R.L. Calderon. 2002. How effective is the TCR in assessing outbreak vulnerability. J. Am. Water Works Assoc. 94(9):88–96. Rose, J.B., S. Dauschner, D.R. Easterline, F.C. Curriero, S. Lele, and J.A. Patz. 2000. Climate and waterborne disease outbreaks. J. Am. Water Works Assoc. 92(9):77–87. Seyfried, P.L., R.S. Tobin, N.E. Brown, and P.F. Ness. 1985. A prospective study of swimmingrelated illness. I. Swimming-associated health risk. Am. J. Public Health 75:1068. USEPA. 1989a. Drinking Water; National Primary Drinking Water Regulations; Total Coliforms (Including Fecal Coliforms and E. coli); Final Rule. Fed. Reg. 54:27544–27568. USEPA. 1989b. Drinking Water; National Primary Drinking Water Regulations; Filtration, Disinfection; Turbidity, Giardia lamblia, Viruses, Legionella, and Heterotrophic Bacteria; Final Rule. Fed. Reg. 54:27486–27541. USEPA. 1998. National Primary Drinking Water Regulations; Interim Enhanced Surface Water Treatment Rule; Final Rule. Fed. Reg. 63:69478–69521. USEPA. 2000. National Primary Drinking Water Regulations; Ground Water Rule; Proposed Rules. Fed. Reg. 65:30194–30274.

4 HISTORY OF THE SAFE DRINKING WATER ACT (SDWA) FREDERICK W. PONTIUS, P.E. Pontius Water Consultants, Inc., Lakewood, Colorado

4.1

INTRODUCTION

Drinking water quality standards and regulations define in quantitative terms water that is ‘‘safe’’ for human consumption. Drinking water must be free from organisms capable of causing disease. It must not contain minerals and organic substances at concentrations that could produce adverse physiological effects. Drinking water should be aesthetically acceptable; it should be free from apparent turbidity, color, and odor and from any objectionable taste. It should also have a reasonable temperature. Water meeting these conditions is called ‘‘potable.’’ The term ‘‘drinking water standards’’ typically refers to numerical limits that define the maximum concentration of contaminants that water may contain to be considered potable (i.e., safe to drink). Drinking water standards may or may not be mandatory or enforceable, depending the agency issuing the standards and the legislative authority under which they are issued. Drinking water regulations are set by a regulatory agency under the authority of federal, state or local law. The Safe Drinking Water Act (SDWA) is the principal law governing drinking water safety in the United States. Enacted initially in 1974 (SDWA 1974), the SDWA as amended (Table 4.1) authorizes the U.S. Environmental Protection Agency (USEPA) to establish comprehensive national drinking water regulations to ensure drinking water safety. This chapter reviews the history of the SDWA from a legal Drinking Water Regulation and Health, Edited by Frederick W. Pontius. ISBN 0-471-41554-5 # 2003 John Wiley & Sons, Inc.

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TABLE 4.1

SDWA and Amendmentsa

Year 1974 1977 1979 1980 1986 1988 1996 2002

a

Law P.L. P.L. P.L. P.L. P.L. P.L. P.L. P.L.

93-523 95-190 96-63 96-502 99-339 100-572 104-182 107-188

Date

Act

Dec. 16, 1974 Nov. 16, 1977 Sept. 6, 1979 Dec. 5, 1980 Jun. 16, 1986 Oct. 31, 1988 Aug. 6, 1996 June 12, 2002

SDWA SDWA Amendments of 1977 SDWA Amendments of 1979 SDWA Amendments of 1980 SDWA Amendments of 1986 Lead Contamination Control Act SDWA Amendments of 1996 Public Health Security and Bioterrorism Preparedness and Response Act of 2002

Codified generally as 42 USC 300f-300j-11.

and regulatory perspective. VanDe Hei and Schaefer (this volume, Chapter 5) provide an insightful review of the development of the SDWA from a sociopolitical perspective. USEPA drinking water regulations require public water systems in the United States to meet specified drinking water quality standards. Regulations may also require that compliance monitoring be conducted, specified treatment be applied, and reports be submitted documenting that regulations are being met. To ensure compliance with water quality regulations, a water utility usually must produce water of a better quality than a standard or regulation would demand. Hence, each water utility needs its own water quality goals to ensure compliance while producing the highest quality tapwater possible within its financial, technical, and managerial capacity.

4.2

EARLY DEVELOPMENT OF DRINKING WATER STANDARDS

Okun (this volume, Chapter 1) has reviewed the early development of drinking water standards. Historically, civilizations began and located within regions of abundant water supplies. Water quality was not very well documented, and little was known about disease as it related to water quality. Early treatment was performed only to improve the appearance or taste of drinking water. No defined standards of quality other than general clarity or palatability were recorded by ancient civilizations (Borchardt and Walton 1971). The growth of community water supply systems in the United States began in Philadelphia. In 1799, a small section was first served by wooden pipes and water was drawn from the Schuylkill River by steam pumps. By 1860, over 400 major water systems had been developed to serve the nation’s major cities and towns. Although municipal water supplies were growing in number during this early period of the nation’s development, healthy and sanitary conditions did not begin

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to improve significantly until the turn of the century. By 1900, an increase in the number of water supply systems to over 3000 contributed to major outbreaks of disease because pumped and piped supplies, when contaminated, provide an efficient means for spreading pathogenic bacteria throughout a community. In the mid- to late 1800s, acute waterborne disease of biological origin was still prevalent in the United States. Following the lead of European investigators, slow sand filters were introduced in Massachusetts by the mid-1870s. Empirical observations showed that this improved the aesthetics of water quality. In the mid-1890s, the Louisville Water Company, in Kentucky combined coagulation with rapid sand filtration, significantly reducing turbidity and bacteria in the water. The Louisville studies refined the knowledge of the process and showed the essential need for pretreatment, including sedimentation for Ohio River water. The next major milestone in drinking water technology was the use of chlorine as a disinfectant. Chlorination was first used in 1908 and was introduced in a large number of water systems shortly thereafter. U.S. drinking water standards have developed and expanded since the early 1900s as knowledge of the health effects of contaminants has increased and the treatment technology to control contaminants has improved. Protection of public health has provided the principal driving force behind development of drinking water standards and regulations. In the United States, federal authority to establish drinking water regulations originated with the enactment by Congress in 1893 of the Interstate Quarantine Act (U.S. Statutes 1893). The first water-related regulation, adopted in 1912, prohibited the use of the common cup on carriers of interstate commerce, such as trains (McDermott 1973). In 1914, the Treasury Standards were established by the U.S. Public Health Service (USPHS), then a part of the Treasury Department. The USPHS revised these standards in 1925, 1942, 1946, and 1962 (USPHS 1925, 1943, 1946, 1962). For a discussion of these early standards prior to the SDWA, see Chapter 1.

4.3

THE SAFE DRINKING WATER ACT OF 1974

Results of a Community Water Supply Study (CWSS) in 1969 by the USPHS generated congressional interest in federal safe drinking water legislation. The first series of bills to give the federal government power to set enforceable standards for drinking water were introduced in 1970. Congressional hearings on legislative proposals concerning drinking water were held in 1971 and 1972 (Kyros 1974). In September 1972 the U.S. Senate passed S. 3994, an original bill reported by the Committee on Commerce, requiring establishment of minimum Federal drinking water standards with enforcement by the states and a program of grants to support state drinking water programs. The House took no action on this bill in the 92nd Congress. Enactment of the initial SDWA is inextricably intertwined with the discovery of trihalomethanes and organic contaminants in drinking water. Symons (2001a,

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2001b) and Okun (Chapter 1) provide an insightful chronicle of this period. Researchers in the Netherlands and at USEPA discovered that a class of compounds, trihalomethanes (THMs), were formed as a byproduct when free chlorine was added for disinfection (Rook 1974; Bellar et al. 1974). Johannes Rook (Netherlands) and Thomas Bellar (USEPA), working independently, in a similar timeframe, on projects not related to chloroform or disinfection byproducts, accidentally discovered that chloroform was created during the disinfection of drinking water (Symons 2001a). Although unrelated, publicity surrounding reports of the discovery of the formation of THMs coincided with the finding of synthetic organic chemicals (SOCs) in the New Orleans water supply. On Nov. 8, 1974, the date of the USEPA Region VI press conference concerning the New Orleans study, USEPA simultaneously announced that a nationwide survey would be conducted to determine the extent of the THM problem in the United States (Symons et al. 1975). This survey was known as the National Organics Reconnaissance Survey (NORS), and was completed in 1975 (discussed below). The true health significance of THMs and SOCs in drinking water was not known, and questions still remain today regarding the health significance of low concentrations of organic chemicals and disinfection byproducts. After more than 4 years of effort by Congress, federal legislation was enacted to develop a national program to protect the quality of the nation’s public drinking water systems. On Nov. 19, 1974, the House debated and passed by voice vote H.R. 13002, a clean bill reported by the House Committee on Interstate and Foreign Commerce. Language of the House bill was then inserted into S. 433. The Senate considered and amended S. 433 on Nov. 26. The House agreed to the Senate amendment Dec. 3, 1974. President Ford signed the SDWA on Dec. 16, 1974 as Public Law 93-523 (Congressional Research Service 1982). Symons (2001a) notes that enactment of the 1974 SDWA generated much confusion and resentment with regard to the national publicity criticizing drinking water quality, and many people were unhappy about passage of the SDWA. USEPA was accused of deliberately planting the THM story just to get the SDWA passed, which was unfounded. Many people within the drinking water industry had difficulty believing that trace concentrations of chemicals with difficult names could be harmful (J. M. Symons 1974). The 1974 SDWA established a cooperative program among local, state, and federal agencies. The act required the establishment of primary drinking water regulations designed to ensure safe drinking water for the consumer. These regulations were the first to apply to all public water systems in the United States, covering both chemical and microbial contaminants. Except for the coliform standard under the Interstate Quarantine Act mentioned previously, drinking water standards were not legally binding until passage of the SDWA. The SDWA mandated a major change in the surveillance of drinking water systems by establishing specific roles for the federal and state governments and for public water suppliers. The federal government, specifically the USEPA, was authorized to set national drinking water regulations, conduct special studies and research, and oversee implementation of the act. The state governments, through their health departments and environmental agencies, are expected to accept the

4.3 THE SAFE DRINKING WATER ACT OF 1974

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major responsibility, called primary enforcement responsibility or primacy, for the administration and enforcement of the regulations set by USEPA under the Act. Public water suppliers have the day-to-day responsibility of meeting the regulations. To meet this goal, routine monitoring must be performed, with results reported to the regulatory agency. Violations must be reported to the public and corrected. Failure to perform any of these functions can result in enforcement actions and penalties. The 1974 Act specified the process by which USEPAwas to adopt national drinking water regulations. Interim regulations [national interim primary drinking water regulations (NIPDWRs)] were to be adopted within 6 months of its enactment. Within about 2 years (by March 1977), USEPA was to propose revised regulations (revised national drinking water regulations) on the basis of a study of health effects of contaminants in drinking water conducted by the National Academy of Sciences (NAS). Establishment of the revised regulations was to be a two-step process. First, the agency was to publish recommended maximum contaminant levels (RMCLs) for contaminants believed to have an adverse health effect based on the NAS study. RMCLs were to be set at a level such that no known or anticipated health effect would occur. An adequate margin of safety was to be provided. These levels were to act only as health goals and were not intended to be federally enforceable. USEPA then established maximum contaminant levels (MCLs) as close to the RMCLs as the agency thought feasible. The agency was also authorized to establish a required treatment technique instead of an MCL if it was not economically or technologically feasible to determine the level of a contaminant. The MCLs and treatment techniques comprise the National Primary Drinking Water Regulations (NPDWRs) and are federally enforceable. The regulations were to be reviewed at least every 3 years. 4.3.1

The National Interim Primary Drinking Water Regulations

Interim regulations were adopted Dec. 24, 1975 (USEPA 1975b) on the basis of the 1962 USPHS standards with little additional health effects support. The interim rules were amended several times before the first primary drinking water regulation was issued (see Table 4.2). The findings of the NORS (mentioned previously) were published in November 1975 (Symons et al. 1975). The four trihalomethanes (THMs)—chloroform, bromodichloromethane, dibromochloromethane, and bromoform—were found to be widespread in the chlorinated drinking waters of 80 cities studied. USEPA subsequently conducted the National Organics Monitoring Survey (NOMS) between 1976 and 1977 to determine the frequency of specific organic compounds in drinking water supplies (USEPA 1978a). Included in the NOMS were 113 community water supplies representing different sources and treatment processes, each monitored 3 times during a 12-month period. NOMS data showed that THMs were the most widespread organic contaminants in drinking water, occurring at the highest concentrations. From the NORS, NOMS, and other surveys, more than 700 specific organic chemicals had been identified in various drinking waters (Cotruvo and Wu 1978).

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TABLE 4.2

History of the NIPDWRs

Regulation

Promulgation Date

NIPDWRs (USEPA 1975b)

Dec. 24, 1975

June 24, 1977

1st NIPDWR Amendment (USEPA 1976a) 2nd NIPDWR Amendment (USEPA 1979) 3rd NIPDWR Amendment (USEPA 1980)

July 9, 1976

June 24, 1977

Inorganic, organic, and microbiological contaminants and turbidity Radionuclides

Nov. 29, 1979

Varied depending on system size

Total trihalomethanesa

Aug. 27, 1980

Feb. 27, 1982

Feb. 28, 1983

March 30, 1983

Special monitoring requirements for corrosion and sodium Identifies best generally available means to comply with THM regulations

4th NIPDWR Amendment (USEPA 1983)

a

Effective Date

Primary Coverage

The sum of chloroform, bromoform, bromodichloromethane, plus dibromochloromethane.

On June 21, 1976, the EDF petitioned the USEPA, alleging that the initial interim regulations set in 1975 did not sufficiently control organic compounds in drinking water. In response, USEPA issued an Advance Notice of Proposed Rulemaking (ANPRM) on July 14, 1976, requesting public input on how THMs and SOCs should be regulated (USEPA 1976b). On Feb. 9, 1978, USEPA proposed a two-part regulation for the control of organic contaminants in drinking water (USEPA 1978b). The first part concerned the control of THMs. The second part concerned control of source water SOCs and proposed the use of GAC adsorption by water utilities vulnerable to possible SOC contamination. The next day, Feb. 10, 1978, the U.S. Court of Appeals, District of Columbia Circuit, issued a ruling in the EDF case filed June 21, 1976 (U.S. Court of Appeals 1978). The court upheld USEPA’s discretion to not include comprehensive regulations for SOCs in the NIPDWRs, but as a result of new data being collected by USEPA, the court told the agency to report a plan for amending the interim regulations to control organic contaminants. The court stated (U.S. Court of Appeals 1978): ‘‘In light of the clear language of the legislative history, the incomplete state of our knowledge regarding the health effects of certain contaminants and the imperfect nature of the available measurement and treatment techniques cannot serve as justification for delay in controlling contaminants that may be harmful.’’

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The agency contended that the proposed rule published the day before satisfied the court’s judgment. Reaction to the proposed regulation on GAC adsorption treatment varied. Federal health agencies, environmental groups, and a few water utilities supported the proposed rule. Many state health agencies, consulting engineers, and most water utilities opposed it (Symons 1984). USEPA responded to early opposition to the GAC proposal by publishing an additional statement in the July 6, 1978, Federal Register (USEPA 1978c). Nevertheless, significant opposition continued based on several technical considerations (Pendygraft et al. 1979a, 1979b, 1979c). USEPA promulgated regulations for the control of THMs in drinking water on Nov. 29, 1979 (USEPA 1979), but subsequently, on March 19, 1981, withdrew its proposal to control organic contaminants by GAC (USEPA 1981). 4.3.2

National Academy of Sciences (NAS) Study

As required by the 1974 SDWA, USEPA contracted with the NAS to have the National Research Council (NRC) assess human exposure via drinking water and the toxicology of contaminants in drinking water. The NRC Committee on Safe Drinking Water published their report, Drinking Water and Health, in 1977 (NAS 1977). Five classes of contaminants were examined: microorganisms, particulate matter, inorganic solutes, organic solutes, and radionuclides. This report, the first in a series of nine, served as the basis for revised drinking water regulations. USEPA published the recommendations of the NAS study on July 11, 1977 (USEPA 1977). The 1977 amendments to the SDWA called for revisions of the NAS study ‘‘reflecting new information which has become available since the most recent previous report [and which] shall be reported to the Congress each two years thereafter’’ (SDWA 1977). NAS reports issued on drinking water related issues are listed in Table 4.3. USEPA often funds the NAS to conduct independent assessments of drinking water contaminants, typically directed by Congress to do so in legislation or by conference committee report. 4.3.3

1977–1980 SDWA Amendments

The SDWA was amended and=or reauthorized in 1977, 1979, and 1980 (Congressional Research Service 1982). At the beginning of the 95th Congress (1977), jurisdiction for the SDWA was transferred from the Senate Committee on Commerce to the Senate Committee on Environment and Public Works. In November 1977 Congress enacted amendments to the 1974 SDWA that reauthorized and revised certain provisions. S. 1528, containing amendments to the SDWA, was signed into law by President Carter Nov. 16, 1977 as Public Law 95-190 (SDWA 1977). Congress again reauthorized the SDWA in 1979. S. 1146, a 3-year extension of authorizations for appropriations for the SDWA, was signed into law by President Carter on Sept. 6, 1979 as Public Law 96-63 (SDWA 1979). During the 96th Congress the House Commerce subcommittee on Health and Environment held oversight hearings on the SDWA. On Sept. 19, 1980, the Committee on Interstate and Foreign Commerce reported a clean bill, H.R. 8117, which the

78

HISTORY OF THE SAFE DRINKING WATER ACT (SDWA)

TABLE 4.3

Drinking Water Studies Completed by the National Academy of Sciences

Study Drinking Water and Health (NAS 1977) Drinking Water and Health, Vol. 2 (NAS 1980a) Drinking Water and Health, Vol. 3 (NAS 1980b)

Drinking Water and Health, Vol. 4 (NAS 1982) Drinking Water and Health, Vol. 5 (NAS 1983) Drinking Water and Health, Vol. 6 (NAS 1986)

Drinking Water and Health, Vol. 7 (NAS 1987a) Drinking Water and Health, Vol. 8 (NAS 1987b) Drinking Water and Health, Vol. 9 (NAS 1989) Health Effects of Ingested Fluoride (NAS 1993) Nitrate and Nitrite in Drinking Water (NAS 1995) Safe Water from Every Tap: Improving Water Service to Small Communities (NAS 1997) Issues in Potable Reuse: The Viability of Augmenting Drinking Water Supplies with Reclaimed Water (NAS 1998) Setting Priorities for Drinking Water Contaminants (NAS 1999a) Identifying Future Drinking Water Contaminants (NAS 1999b) Risk Assessment of Exposure to Radon in Drinking Water (NAS 1999c)

Scope Examines microorganisms, particulate matter, inorganic solutes, and radionuclides Evaluated disinfectants, disinfection byproducts, and granular activated carbon Evaluates several epidemiologic studies, assesses the toxicology of selected drinking water contaminants, and examines the contribution of drinking water to the mineral nutrition in humans Examines distribution system water quality and toxicity of selected inorganic and organic contaminants Reviews the toxicology of selected synthetic organic chemicals, uranium, arsenic, and asbestos Examines developmental effects, reproductive toxicology, neurotoxic effects, mechanisms of carcinogenesis, dose–response extrapolations, risk assessment issues, and the toxicology of selected contaminants Again addresses disinfectants and disinfection byproducts Focuses exclusively on the application of pharmacokinetics in risk assessment Complex mixtures Evaluates the MCLG and MCL for fluoride Evaluates the MCLG and MCL for nitrate and nitrite Presents institutional and technological options for improving the management efficiency and financial stability of small water systems Reviews current issues associated with the potable use of reclaimed water

Evaluates decision processes for selecting contaminants for regulation Evaluates options for selecting contaminants for future regulation Evaluates health risks of radon in drinking water (continued )

4.4 1986 SDWA AMENDMENTS

TABLE 4.3

79

(Continued)

Study Arsenic in Drinking Water (NAS 1999d) Copper in Drinking Water (NAS 2000a) Re-Evaluation of Drinking Water Guidelines for Diisopropyl Methylphosphonate (USEPA 2000b) Classifying Drinking Water Contaminants for Regulatory Consideration (NRC 2001)

Scope Health risk assessment of arsenic Evaluates the MCLG for copper Reevaluates drinking water guidelines

Recommends a contaminant selection process

House passed by voice vote on Sept. 23. The House-passed bill was referred to the Senate Committee on Environment and Public Works, which took no action. On Nov. 19, 1980, the Senate discharged the Committee from consideration of H.R. 8117 and passed the bill by voice vote. The bill was signed into law by President Carter Dec. 5, 1980 as Public Law 96-502 (SDWA 1980). 4.4

1986 SDWA AMENDMENTS

Congress severely underestimated the time required for USEPA to develop credible regulations. USEPA’s slowness in regulating contaminants and its failure to require GAC treatment for organic contaminants served as a focal point for discussion of possible revisions to the law. Reports in the early 1980s of drinking water contamination by organic contaminants and other chemicals (Westrick et al. 1984) and pathogens such as Giardia lamblia (Craun 1986) aroused congressional concern over the adequacy of the SDWA. The rate of progress made by USEPA to regulate contaminants was of particular concern. Both the House and Senate considered various legislative proposals beginning in 1982 that informed the SDWA debate and helped to shape the SDWA amendments enacted in 1986. Four oversight hearings were held in 1982 by the Senate Environment and Public Works Subcommittee on Toxic Substances and Environmental Oversight. Congress began considering broad amendments to the SDWA in 1983. The SDWA Amendments of 1983 (H.R. 3200) was introduced in the 98th Congress. The House Energy and Commerce Subcommittee on Health and the Environment held hearings on the SDWA. Issue-specific legislation was introduced to provide for the protection of sole source underground drinking water supplies. The House passed an SDWA reauthorization bill (H.R. 5959) on Sept. 18, 1994 (House Report 98-1034). An SDWA reauthorization bill (S. 2649) was passed by the Senate on Sept. 28, 1984 (Senate Report 98-641). However, the 98th Congress ended before a conference agreement could be reached (Congressional Research Service 1993).

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HISTORY OF THE SAFE DRINKING WATER ACT (SDWA)

The 99th Congress built on the previous Congress’ efforts to reauthorize the SDWA. S. 124 was introduced Jan. 2, 1985, reported by the Senate Environment and Public Works Committee on May 15, 1985 (Senate Report 99-56), and passed by the Senate on May 16, 1985. The companion bill, H.R. 1650, was introduced March 21, 1985, and reported by the House Energy and Commerce Committee June 11, 1985 (House Report 99-168). On June 17, 1985, the House considered and passed H.R. 1650, passed S. 124 with amendments, and tabled H.R. 1650. A conference committee was formed and the conference report on S. 124 (House Report 99-575) was debated and passed in the House on May 13, 1986 and in the Senate on May 21, 1986. The President signed S. 124 into law on June 19, 1986 as Public Law 99-339 (SDWA 1986). To strengthen the SDWA, especially the regulation-setting process and groundwater protection, most of the original 1974 SDWA was amended in 1986. Major provisions of the 1986 amendments included (Cook and Schnare 1986; Dyksen et al. 1988; Gray and Koorse 1988):  Mandatory standards for 83 contaminants by June 1989.  Mandatory regulation of 25 contaminants every 3 years.  National interim drinking water regulations were renamed national primary drinking water regulations.  Recommended maximum contaminant level goals (RMCLs) were replaced by maximum contaminant level goals (MCLGs).  Required designation of best available technology for each contaminant regulated.  Specification of criteria for deciding when filtration of surface water supplies is required.  Disinfection of all public water supplies.  Monitoring for contaminants that are not regulated.  A ban on lead solders, flux, and pipe in public water systems.  New programs for wellhead protection and protection of sole source aquifers.  Streamlined and more powerful enforcement provisions. The 1986 amendments significantly increased the rate at which USEPA was to set drinking water standards. Resource limitations and competing priorities within the agency prevented USEPA from fully meeting the mandates of the 1986 amendments. Figure 4.1 summarizes the growth of regulated contaminants under the SDWA from initial enactment to the present. The mandate to regulate 25 contaminants every 3 years simply could not be met, and after 1992 regulations ceased to be issued until the law was amended in 1996. 4.5

1988 LEAD CONTAMINATION CONTROL ACT

On Dec. 10, 1987, the House Subcommittee on Health and Environment held a hearing on lead contamination of drinking water. At that hearing the U.S. Public

4.6 1996 SDWA AMENDMENTS

Figure 4.1

81

Growth of regulated contaminants.

Health Service warned that some drinking water coolers may contain lead solder or lead-lined water tanks that release lead into the water they distribute. Data submitted to the subcommittee by manufacturers indicated that close to 1 million water coolers were in use at that time that contained lead. A subcommittee hearing was subsequently held on July 13, 1988 to consider H.R. 4939, the Lead Contamination Control Act. The bill had widespread support and moved swiftly through the House and Senate (Congressional Research Service 1993). The Lead Contamination Control Act was enacted Oct. 31, 1988 as Public Law 100-572 (LCCA 1988). This law amended the SDWA to, among other things, institute a program to eliminate lead-containing drinking water coolers in schools. Part F—Additional Requirements to Regulate the Safety of Drinking Water—was added to the SDWA. USEPA was required to provide guidance to states and localities to test for and remedy lead contamination in schools and daycare centers. It also contains specific requirements for the testing, recall, repair, and=or replacement of water coolers with lead lined storage tanks or with parts containing lead. Civil and criminal penalties for the manufacture and sale of water coolers containing lead are set.

4.6

1996 SDWA AMENDMENTS

The 1986 SDWA amendments authorized congressional appropriations for implementation of the law through fiscal year 1991. Reauthorization was not completed until 1996. 4.6.1

Reauthorization Issues Emerge

Several studies following the 1986 SDWA amendments set the stage for potential changes to the SDWA. A 1988 study sponsored and supported by consumer advo-

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HISTORY OF THE SAFE DRINKING WATER ACT (SDWA)

cate Ralph Nader drew attention to trace organic chemicals found in drinking water (Conacher 1988). A study by the National Wildlife Federation released in 1988 (Dean 1988) and updated in 1989 (Dean 1989) captured media attention by highlighting violations of the SDWA. Both reports characterized USEPA’s enforcement of the SDWA as virtually nonexistent. Studies such as these raise the issue of whether public health is threatened by the failure of water utilities to comply with SDWA regulations. Although noncompliance occurs mostly in small systems, the issue of noncompliance raises concerns about the adequacy of the SDWA and USEPA’s drinking water program and the ability of water suppliers to provide safe drinking water to their customers. The GAO assessed the implementation of the SDWA program by USEPA and the states at the request of the Subcommittee on Environment, Energy, and Natural Resources (Committee on Government Operations, House of Representatives). The GAO report (USGAO 1990) was released June 8, 1990, and was the subject of Subcommittee oversight hearings held Aug. 2, 1990 (Hembra 1990). The GAO found that published USEPA data indicate that most water systems are complying with monitoring and MCL requirements and that the relatively few violating systems have generally committed minor infractions but that considerable noncompliance existed. USEPA sponsored a workshop in September 1990 that served as a starting point for USEPA to identify issues related to the SDWA (Schnare 1990). Representatives from the drinking water community, state agencies, USEPA, environmental organizations, and others presented their views on policy and technical issues that could be addressed during reauthorization. The National Drinking Water Advisory Council (NDWAC) compiled comments from a survey it conducted on changes to the SDWA (Kessler and Schnare 1991) and developed recommendations (NDWAC 1993). 4.6.2

GAO Studies Note Deficiencies

The GAO released three studies in 1992 regarding implementation of the SDWA. An audit of 28 water systems in six states revealed high rates of noncompliance with SDWA public notification requirements (USGAO 1992a). The public notification requirements themselves were cited as a major cause of noncompliance, particularly for small systems, because the requirements have been difficult to understand and implement. A July 6, 1992, GAO report examined the gap between available resources and drinking water program needs (USGAO 1992b). Funding shortages at the federal, state, and water system levels were found to contribute to implementation and compliance problems. It is estimated that by 1995, the total state and federal program requirements will exceed state and federal resources by $150 million. The solesource aquifer program was examined in another GAO report issued Oct. 13, 1992 (USGAO 1992c). The principal finding was that mechanisms used to identify projects for possible USEPA review were weak. The GAO released three additional studies in 1993. The wellhead protection program was the focus of a GAO report issued April 14, 1993 (USGAO 1993a).

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Several barriers were found to hinder states’ efforts to develop and implement wellhead protection programs, including (1) opposition at the local level against states’ enactment of land-use controls and (2) a general lack of public awareness about the vulnerability of drinking water to contamination and the need to protect wellhead areas. A severe shortage of funds was identified as the underlying cause of these barriers and the primary problem affecting state wellhead protection programs. GAO conducted a nationwide questionnaire and reviewed 200 sanitary surveys conducted in four states (Illinois, Montana, New Hampshire, and Tennessee). Their report, issued April 9, 1993, disclosed that sanitary surveys are often deficient in how they are conducted, documented, and=or interpreted (USGAO 1993b). Many of the 200 sanitary surveys revealed recurring problems with water systems’ equipment and management, particularly among small systems. Regardless of system size, deficiencies previously disclosed frequently went uncorrected. The gap between the needs and available resources of state drinking water programs was a major barrier severely affecting states’ capabilities to conduct sanitary surveys. Severe resource constraints have made it increasingly difficult for many states to effectively carry out the monitoring, enforcement, and other mandatory activities to retain primacy. A June 25, 1993, GAO report concluded that the funding difficulties faced by states are likely to worsen and that resolving the primacy issue involves bringing the program’s costs in line with resources (USGAO 1993c). State funding needs represent only a fraction of the expenditures that public water systems must make to comply with SDWA requirements. Results of a survey released in 1993 by the Association of State Drinking Water Administrators (ASDWA) identified an immediate need of $2.738 billion for SDWA-related infrastructure projects in 35 states (ASDWA 1993). Insufficient funding, political interference, and mismanagement were cited in a 1993 study by the Center for Resource Economics as the three main obstacles preventing USEPA from fully meeting its environmental statutory mandates (Center for Resource Economics 1993). On March 9, 1994, GAO released the results of an audit of the ability of small systems to comply with SDWA regulations (USGAO 1994). The study found that states are experimenting with technology- and management-based approaches to help small community drinking water systems comply with SDWA regulations, but that barriers exist. The report recommended that USEPA revise its priorities to place greater emphasis on developing and maintaining viability programs.

4.6.3

102nd Congress

Minimal formal activity on the SDWA took place during the 102nd Congress. Rep. Henry Waxman (D–CA) introduced H.R. 2840, Lead Contamination Control Act Amendments, which was intended to rewrite USEPA’s lead rule. A companion bill, S. 1445, Lead in Drinking Water Reduction Act, was introduced in the Senate by Frank Lautenberg (D–NJ). The House Subcommittee on Health and Environment held a hearing May 10, 1991 on progress in carrying out the SDWA provisions for control of drinking water contamination.

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During the closing months, Senator Pete Domenici (R–NM) introduced bill S. 2900, that would have established a moratorium on implementation of drinking water regulations by prohibiting USEPA from spending money to implement and enforce regulations in place retroactive to December 1989. Senator Domenici offered S. 2900 as a floor amendment when the Senate considered the Veterans’ Administration (VA), Housing and Urban Development (HUD), and Independent Agencies appropriation bill for fiscal year (FY) 1993. This bill provides funding for USEPA and several other government agencies. To counter Senator Domenici, Senators John Chafee (R–RI) and Frank Lautenberg (D–NJ) offered an alternative amendment. The Chafee–Lautenberg amendment required USEPA to conduct a study on the implementation of the SDWA. It also required the agency to conduct a separate study on radon. The Domenici amendment was narrowly defeated in the Senate by only six votes. The Chafee–Lautenberg amendment was adopted (Congressional Record 1992) and signed into law Oct. 6, 1992 (Public Law 102-389). 4.6.4

103rd Congress

Activity increased in the 103rd Congress with the introduction of several proposed bills. The first comprehensive reform bill was S. 767, introduced by Senator Don Nickles (R–OK). An identical companion bill, H.R. 2344, was introduced in the House by Rep. James Walsh (R–NY). These proposals did not move forward and simply served to stimulate discussion on various SDWA issues. State Revolving Loan Fund Proposed Debate on the SDWA began in earnest when proposals were introduced in the House to authorize a drinking water state revolving loan fund (DWSRF) for drinking water. The proposal for a DWSRF was included in President Clinton’s economic stimulus package offered early in 1993. A jurisdictional dispute arose between two House committees vying for control over the DWSRF, and two competing bills were introduced, one for each committee. Although the president’s package was eventually defeated by Congress, the DWSRF bills moved forward. Separate DWSRF bills were not introduced in the Senate because of the desire to deal with DWSRF funding at the same time that other SDWA issues were considered. H.R. 1701, introduced by Rep. Henry Waxman (D–CA), authorized an DWSRF as part of the SDWA. A proposal to amend the Clean Water Act (CWA) to expand the scope of the existing clean water state revolving loan fund (CWSRF) to include drinking water was introduced by Rep. Norman Mineta (D–CA), who chaired the House Committee on Public Works and Transportation that has jurisdiction over the CWA. Both bills were reported out of committee. A DWSRF was included in President Clinton’s fiscal year 1994 budget, initially funded at $600 million, with additional funding planned at $1 billion per year thereafter. Because authorizing legislation for this money was not in place, it could not be appropriated and spent. Therefore, Congress decided to include the money in the budget with a condition that it could not be spent until authorizing

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legislation was passed. This meant that such legislation must have been in place before Oct. 1, 1994, or the money could not be appropriated for fiscal year 1994. USEPA Recommendations and Reports to Congress USEPA’s recommendations for reauthorization were released by Administrator Carol Browner on Sept. 8, 1993, during a speech before the National Association of Towns and Townships (Browner 1993). A list of 10 recommendations was issued based on USEPA’s report to Congress on SDWA implementation released a few days later. USEPA’s report on SDWA implementation was submitted to Congress in September 1993 (USEPA 1993). In this report, USEPA estimated that compliance with the standards for 84 contaminants regulated to date is expected to cost public water systems approximately $1.4 billion (in 1991 dollars) per year by 1995 (Auerbach 1994). Individual household costs to comply with federal drinking water rules were estimated to range from a few dollars per year in metropolitan areas to several hundred dollars per year in small communities that have contamination problems. The report estimated that the 1993 state funding shortfall for implementing federal drinking water requirements was about $162 million; needs totaled $304 million, yet only $142 million was available from state and federal sources. USEPA’s report to Congress on radon was published in March 1994 (USEPA 1994a). The report revised the agency’s risk and cost assessments for radon in drinking water. USEPA estimated that approximately 19 million people are exposed to a radon level above the then-proposed MCL of 300 pCi=L. The total cost to treat radon in drinking water to below the then proposed MCL was estimated at $272 million. Natural Resources Defense Council (NRDC) Report The Natural Resources Defense Council (NRDC) released a report, Think before You Drink, the Failure of the Nation’s Drinking Water System to Protect Public Health, on Sept. 17, 1993, which highlighted violations of the SDWA (Olson 1993). The report reviewed a number of problems associated with SDWA implementation and presented a set of proposals for SDWA reforms. The NRDC report made many serious claims regarding the quality of U.S. drinking water supplies and served as the first shot fired in an intense battle over the SDWA. In response, the National Rural Water Association (NRWA) issued a statement claiming NRDC sensationalized the report findings (Carroll 1993). The NRDC report attracted media attention, including a page-one story in the Sept. 27, 1993, USA Today (USA Today 1993a). Subsequent letters to the editor challenged the report’s findings and conclusions (USA Today 1993b, Wade 1993, Ronnebaum 1993). House and Senate Consider Reauthorization Bills On Oct. 14, 1993, Senator Max Baucus (D–MT) introduced S. 1547 and a hearing on this bill was held Oct. 27, 1993, by the Senate Committee on Environment and Public Works, which Senator Baucus chaired. Senator John Chafee (R–RI), a key player in the SDWA debate, decided not to cosponsor S. 1547 because of disagreement over some of the

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bill’s provisions. S. 1547 received a mixed response from environmental groups, and some of its provisions were generally opposed by various interest groups from both sides. On Oct. 27, 1993, the problem of unfunded federal mandates received national attention at a press conference held by national public interest groups representing state and local governments. These groups included the National Governors Association (NGA), the U.S. Conference of Mayors (USCM), the National Association of Counties, and the National Conference of State Legislatures (NCSL). Unfunded federal mandates are laws passed by the U.S. Congress imposing requirements on state and local governments without providing adequate federal funds to implement those requirements. The cost of complying with environmental laws in general and the SDWA in particular, in the absence of federal, state, and local financial resources, caused many groups to pressure Congress for relief. Concurrently with the October 27 Capitol Hill press conference on unfunded mandates, H.R. 3392 was introduced by Rep. Jim Slattery (D–KS) and Rep. Thomas Bliley (R–VA). This bill received the most support of all of the proposed SDWA bills. H.R. 3392 was supported by the NGA, the National League of Cities, USCM, NCSL, ASDWA, NRWA, AWWA, the National Water Resources Association, the Association of Metropolitan Water Agencies, and the National Association of Water Companies. The bill was opposed by the National Wildlife Federation, the NRDC, Friends of the Earth, Alliance to End Childhood Lead Poisoning, National Education Association, and the National Parent Teacher Association. A key issue proposed by H.R. 3392 was a change in how drinking water standards are set. Proponents of H.R. 3392 argued that changes to the process are needed so that rational standards can be developed to maximize health protection with the limited funds available. Opponents of H.R. 3392 argued that it merely served to roll back existing standards (Waxman 1994). On Nov. 22, 1993, H.R. 3686 was introduced by Rep. Pat Roberts (R–KS). This bill would suspend the requirements of the SDWA until the cost to state and local governments of implementing its requirements was fully funded by the federal government. Although this bill did not receive serious consideration, it expressed the strong attitude many elected officials had regarding SDWA funding. On March 10, 1994, Senator Pete Domenici (R–NM) introduced S. 1920. The bill was similar to H.R. 3392, but included provisions for a drinking water State Revolving Loan Fund (SRLF). Although the bill was referred to the Senate Environment and Public Works Committee, it was not considered during markup of S. 1547. On March 24, 1994, Senator Domenici announced his intention to negotiate for inclusion of provisions from S. 1920 to give water utilities more relief from unfunded mandates (Domenici 1994). Senator Domenici offered several amendments during floor deliberations on S. 2019. On April 18, 1994, Reps. Lambert (D–AR), Synar (D–OK), and Studds (D–MA) introduced H.R. 4314. The provisions of this bill generally followed the Clinton administration recommendations. H.R. 4314 served as an alternative bill for those representatives who desired to support an SDWA bill, but did not want to support H.R. 3392 because of opposition by Rep. Waxman (D–CA).

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The Senate Environment and Public Works Committee developed changes to S. 1547 in response to testimony at the hearing and other comments. The committee met to consider amendments to S. 1547 in March 1994. On March 24, the committee completed markup and ordered reported, by a unanimous vote, an original bill (S. 2019) that incorporated the amendments to S. 1547. After substantial floor amendment, S. 2019 was passed by the Senate May 19, 1994. With action completed in the Senate, the focus of attention shifted to the House of Representatives. Rep. Henry Waxman (D–CA), who strongly opposed the standardsetting provisions of H.R. 3392, threatened a legislative stalemate (Waxman 1994). Rep. Waxman chaired the House Subcommittee on Health and Environment, in which H.R. 3392 and other SDWA legislation was first considered in the House. Environmental Groups Oppose House Bill At the same time H.R. 3392 received strong support in the House, environmental interest groups mounted a strong campaign to defeat it. On Feb. 23, 1994, a coalition that included the NRDC, Friends of the Earth, the Environmental Defense Fund, National Wildlife Federation, National Audubon Society, Sierra Club, Citizen Action, U.S. Public Interest Group, and Physicians for Social Responsibility wrote to members of the House of Representatives urging them to oppose H.R. 3392. A March 4, 1994, memo from Erik Olson, a lobbyist for NRDC, to the heads of the NRDC, National Audubon Society, National Wildlife Federation, the Environmental Defense Fund, Friends of the Earth, and the Sierra Club cited specific actions to defeat reauthorization of the SDWA through ‘‘immediate CEO meetings to ask for a delay’’ and ‘‘to allow time to organize a stronger media, grass roots and lobbying campaign’’ (Olson 1994a). Environmental lobbyists plan ‘‘to pour major resources’’ into their efforts on the SDWA, and ‘‘may move to a kill strategy.’’ This strategy was successful in achieving delay of the markup for S. 1547; environmentalists convinced Senator Baucus to delay the markup from March 15 to March 24, which allowed time for the coalition of environmental groups to place a full-page ad in the New York Times. The ad appeared the day markup began and denounced actions by water utilities that the environmental groups believed to be aimed at weakening the SDWA health standards. On March 14, 1994, NRDC released a report titled Victorian Water Treatment Enters the 21st Century (Cohen and Olson 1994). This study was designed specifically to influence SDWA reauthorization. It presents a critique of current water treatment practice and proceeds to make the judgment that water utilities have been irresponsible in their choices for treatment and maintenance. This charge was rejected by water suppliers in general (Parmelee 1994). The report encouraged opposition to H.R. 3392 and S. 1920. However, the report contained inconsistencies and was characterized as being ‘‘laced with the language of propaganda’’ (Parmelee 1994, Waterweek 1994). The NRDC hosted a press conference on July 17, 1994 to release a 1992=93 update of their report, Think before You Drink (Olson 1994b). The report stated that between 1992 and 1993, one out of five Americans drank water contaminated by unlawfully high levels of toxic chemicals, microbes, and other pollutants, or water

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that was inadequately treated for those pollutants. The report was released simultaneously in more than 50 locations throughout the United States. Prior to the press conference, Erik Olson, NRDC senior attorney, and USEPA Administrator Carol Browner appeared on Good Morning America to discuss the NRDC report. Reauthorization Dies in Closing Days With the end of the 103rd Congress close at hand, pressure to take action on an SDWA measure increased. After many months of negotiation and delay, the House Health and Environment Subcommittee finally took action to mark up H.R. 3392 on Sept. 20, 1994, more than one year after its introduction. The full House Committee on Energy and Commerce also took action that day to pass H.R. 3392, after making substantial amendments. The full House of Representatives passed H.R. 3392 under suspension of the rules on Sept. 27, 1994, less than 2 weeks before adjournment. Disagreement over procedural strategy and legislative language killed the 103rd Congress’ chances to reauthorize the SDWA. Because of limited time, convening a formal conference committee was not possible. This meant that the committee staffs were faced with developing a compromise between S. 2019 and H.R. 3392 that would be acceptable to both chambers. Such a task was an impossible dream. For example, S. 2019 included a risk assessment amendment offered by Senator Johnston (D–La) that was strongly opposed by environmental groups. The Senate overwhelmingly passed this amendment and (judging by earlier votes in the House of Representatives on USEPA cabinet legislation) the majority of the House would also have supported it. Congressman Henry Waxman (D–CA) personally visited the Senate floor and lobbied senators to block the SDWA bill in the closing days of Congress to try to avoid having to consider a Senate-passed bill with risk assessment provisions. Disputes over amendments regarding takings, private property rights, and Davis–Bacon labor provisions also contributed to doom passage of an SDWA bill in the 103rd Congress. In the end, pure election-year politics regarding non-SDWA issues killed the SDWA. 4.6.5

USEPA Redirection of Regulatory Priorities

Limited resources forced USEPA to determine how many regulations can be funded and in what order. The agency initiated a process in late 1994 to redirect its regulatory priorities, which had a significant effect on discussions regarding SDWA reauthorization. A draft strategic plan was prepared in December 1994 (USEPA 1994b). Based on discussions of this plan, USEPA asked the U.S. District Court for Oregon to extend certain regulatory deadlines so that new priorities may be set for the highest-risk substances (BNA 1995). The request for an extension was submitted Jan. 9, 1995, in an amended consent decree signed by Robert Perciasepe, USEPA’s assistant administrator for water (U.S. Court of Appeals 1995). An extension was granted until Aug. 1, 1995, for USEPA to develop new rulemaking schedules. This deadline was extended several times because of Congressional delays in finalizing the agency’s FY 1996 budget. USEPA initiated discussions on possible realignment of its priorities with the public at a meeting held Jan. 19, 1995. Select groups were asked to help the agency

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select and shape a range of potential actions to refocus and redesign the nation’s drinking water program.

Strengthening the Safety of Our Drinking Water To initiate the comprehensive review and redirection of the federal safe drinking water program, USEPA released a report, Strengthening the Safety of Our Drinking Water, in March 1995 (USEPA 1995a). This report included the following agenda for action intended to influence reauthorization of the SDWA: 1. 2. 3. 4. 5.

Give Americans more information about our drinking water Focus safety standards on the most serious health risks Provide technical assistance to protect source water and help small systems Reinvent federal–state partnerships to improve drinking water safety Invest in community drinking water facilities to protect human health

Also included in the report was a discussion of the following eight topics that were to be the focus of stakeholder meetings: regulatory reassessment, scientific data needs, treatment technology, health assessment, analytical methods, source water protection, small systems capacity building, and focusing and improving implementation.

Stakeholder Meetings USEPA held a series of public meetings in 1995 to gain input on how USEPA should redirect and improve its drinking water programs (USEPA 1995b, 1995c, 1995d). These meetings resulted in the development of a priority ranking of contaminants to be regulated that was released June 21, 1995 (Auerbach 1995a). Stakeholders indicated at the initial regulatory reassessment meeting on March 13, 1995, that they did not want to address existing regulations. USEPA recognized that a statutory mandate to review existing rules exists. However, the agency did not have the resources to conduct these reviews, and had no schedule to do so. The agency had planned to consider contaminants regulated in the past as candidates for future priority lists when new information indicates that they should be rereviewed (Auerbach 1995b).

USEPA Drinking Water Redirection Plan On Nov. 29, 1995 (USEPA 1995e), USEPA released for public comment a draft comprehensive drinking water program redirection plan (USEPA 1995f ). This document reported the results of the stakeholder meetings mentioned above and included a priority listing of activities. The priorities and principles proposed in this document served as a basis for discussion of needed revisions to the SDWA. The final National Drinking Water Program Redirection Strategy report was issued in June 1996 (USEPA 1996).

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4.6.6

HISTORY OF THE SAFE DRINKING WATER ACT (SDWA)

104th Congress Activity

The 104th session of Congress began on Jan. 4, 1995, but the signs of change were evident following the November 1994 elections. New members, new committee structures, and a new political order set the stage for Congress to shape and consider legislative proposals inconceivable in prior years. House and Senate Pass Reauthorization Bills In the House of Representatives, the SDWA was charged to the Commerce Committee (previously the Energy and Commerce Committee), chaired by Rep. Thomas Bliley (R–VA). Bliley cosponsored H.R. 3392 in the 103rd Congress. The Health and Environment Subcommittee, chaired by Michael Bilirakis (R–FL), first considered SDWA legislative proposals in the House. To stimulate discussion, Rep. John Dingell (D–MI) introduced H.R. 226, a bill identical to H.R. 3392 as passed by the House in the 103rd Congress. On Dec. 7, 1995, Rep. E.G. (Bud) Shuster (R–PA) introduced H.R. 2747. This bill amended the Federal Water Pollution Control Act (Clean Water Act or CWA) to create water supply infrastructure accounts within existing CWSRF for the state’s use in making loans for the construction of and improvements to drinking water supply infrastructure. This bill rekindled a longstanding jurisdictional dispute between the House Committee on Transportation and Infrastructure and House Commerce Committee, which is responsible for the SDWA. In the Senate the SDWA was under the jurisdiction of the Environment and Public Works Committee chaired by John Chafee (R–RI). Senator Chafee chaired the committee when the SDWA was amended in 1986 and has a more liberal view of environmental protection than his conservative Republican colleagues. The Subcommittee on Drinking Water, Fisheries, and Wildlife, chaired by Dirk Kempthorne (R–ID), was charged with drafting an SDWA reform bill. S. 1316 was introduced Oct. 11, 1995, and hearings were held Oct. 19, 1995. Markup of the bill took place on Nov. 7, 1995 (Senate Report No. 104-169), and the bill was passed by the Senate Nov. 29, 1995. Following passage of S. 1316, the focus of SDWA reauthorization activity shifted to the House of Representatives. On Dec. 12, 1995, Rep. Timothy P. Johnson (D–SD), introduced H.R. 2762 to address concerns regarding regulation of sulfate. The provisions of this bill mirrored S. 1316. Hearings on the SDWA held Jan. 31, 1996 by the House Health and Environment Subcommittee provided the basis for discussions to develop a bipartisan bill in the House. Discussion among Commerce Committee staff to develop a bipartisan SDWA reauthorization proposal progressed for several months. On March 6, 1996, Rep. Pomeroy (D–ND) introduced H.R. 3038, a bill similar to S. 1316. On March 26, 1996, the majority staff floated a comprehensive proposal, which stimulated several additional proposals and counterproposals in an attempt to negotiate a bipartisan agreement. On April 18, 1996, Rep. Waxman introduced H.R. 3280, the Water Quality Public Right-to-Know Act of 1996. This bill required each community water system to issue a report at least once annually to its consumers on the level of

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contaminants in the drinking water purveyed by that system. On April 23, 1996, Rep. Lowey introduced H.R. 3293, the Safe Drinking Water Estrogenic Substances Screening Program Act, to establish a screening program for estrogenic substances. The House Subcommittee on Health and Environment met on June 6, 1996, in an open markup session to consider draft SDWA legislation. The Subcommittee unanimously approved the introduction of a clean bill for full consideration. The bipartisan bill, H.R. 3604, the Safe Drinking Water Act Amendments of 1996, was introduced by Rep. Bliley (R–VA) on June 10, 1996. The House Commerce Committee met in an open markup session on June 11, 1996, and ordered H.R. 3604 to be reported to the House, as amended (House Report 104-632). H.R. 3604 was passed by the House of Representatives on June 25, 1996, under suspension of the rules. Public Law 104-182 Enacted A conference committee was formed to resolve the differences between the Senate and House SDWA bills. The conference committee report was filed on Aug. 1, 1996 (Conference Report 104-741). The House and Senate both approved the conference report on Aug. 1, 1996. The SDWA Amendments of 1996 were signed into law as Public Law 104-182 by President Clinton on Aug. 6, 1996. The SDWA amendments of 1996 made substantial revisions to the SDWA and 11 new sections were added (SDWA 1996, Pontius 1996). Statutory requirements in the 1996 SDWA amendments and related deadlines are summarized in Table 4.4. USEPA has aggressively pursued implementation of the 1996 SDWA amendments. A section-by-section summary of the SDWA is provided in Appendix C, and the full text appears in Appendix D. However, one issue is worthy of discussion to conclude this section. During deliberations on the SDWA amendments in the 104th Congress, both the U.S. Senate and the House of Representatives approved legislative changes and report language that would have changed the SDWA legislative history regarding maximum contaminant level goals for carcinogens. At the conference, the Senate receded from its legislative provision and report language (found in Senate Report 104-169, pp. 30–33) with respect to maximum contaminant level goals for carcinogens. The House receded from all its report language on the same subject (House Report 104-632, the first paragraph on p. 28). The conferees agreed that the SDWA Amendments of 1996 make no changes to the provision or legislative history for MCLGs (Congressional Record 1996).

4.7 PUBLIC HEALTH SECURITY AND BIOTERRORISM PREPAREDNESS AND RESPONSE ACT In the aftermath of the Sept. 11, 2001, terrorist attacks on the World Trade Center in New York City and the Pentagon in Alexandria, Virginia, Congressional staff and committees conducted investigations and hearings to identify needed measures to ensure the security of public water systems in the United States. Several bills were introduced in each chamber that addressed in some way drinking water system

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TABLE 4.4 Statutory Requirements in the 1996 SDWA Amendments and Related Deadlines 1997 February 2, 1997 Report to Congress—Drinking Water Infrastructure Needs Survey (including Indian tribes) Develop plan for additional research on cancer risks from exposure to low levels of arsenic (consult with NAS, other stakeholders) Develop study plan to support development of the DBPs=microbial pathogen rules (in consultation with the Secretaries of HHS and Agriculture) Complete review of existing state capacity development efforts and publish information to assist states and PWSs with capacity development efforts Initiate partnership with states, PWSs, and the public to develop information for states on recommended operator certification requirements (released 2=28=97) Drinking Water State Revolving Fund (DWSRF) Guidelines (no statutory deadline) (agreement 2=28=97) Contract with NAS to conduct peer-reviewed assessment of the health risk reduction benefits associated with various radon mitigation alternatives (no statutory deadline) (released 3=12=97) Develop allotment formula for states on the basis of 1997 Drinking Water Needs Survey (no statutory deadline) August 6, 1997 Issue guidelines for alternative monitoring requirements Guidance establishing procedures for state application for groundwater protection grants Publish list of technologies that meet the Surface Water Treatment Rule for systems serving 10,000–3300 persons, 3300–500 persons, and 500–25 persons Guidance to states for developing source water assessment programs Guidance to states to assist in developing source water petition programs State Primacy Agencies submit to USEPA a list of community water systems and NTNC water systems that have a history of significant noncompliance and reasons for noncompliance 1998 January 1, 1998 States submit to USEPA first (annual) compliance report February 6, 1998 Publish a list of contaminants not subject to any proposed or final national primary drinking water regulation (must include sulfate) Publish information to assist states in developing affordability criteria Publish information on recommended operator certification requirements, resulting from partnership with states, public water systems, and the public July 1, 1998 Issue first (annual) report summarizing and evaluating state compliance reports August 6, 1998 Publish guidelines for small system water conservation programs Promulgate regulation on consumer confidence reports Review and revise as necessary existing monitoring requirements for not fewer than 12 contaminants

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TABLE 4.4

93

(Continued)

Publish guidance on variance technologies for existing regulations for systems serving 10,000–3300 persons, 3300–500 persons, and 500–25 persons Promulgate regulations for variances and exemptions Publish list of technologies that achieve compliance for existing rules (except SWTR) for systems serving 10,000–3300, 3300–500, 500–25 Publish guidance on capacity development describing legal authorities and other means to ensure that new community water systems and nontransient, noncommunity water systems demonstrate capacity Conduct waterborne disease occurrence studies (with the Centers for Disease Control and Prevention) End of transition period for water suppliers determined to be public water system as a result of modifications to Sec. 1401(4) (constructed conveyances) November 1998 Promulgate Stage I Disinfectants and Disinfection Byproducts Rule Promulgate Interim Enhanced Surface Water Treatment Rule 1999 February 1999 Complete sulfate study with the Centers for Disease Control and Prevention to establish a reliable dose–response relationship Publish guidelines specifying minimum standards for certification and recertification of water system operators Publish health risk reduction benefits=cost analysis for potential radon standards Deadline for State Primacy Agency submission of programs for source water assessments August 6, 1999 Report to Congress on state groundwater protection programs Propose radon standard Establish National Contaminant Occurrence Data Base Promulgate final regulation establishing criteria for a monitoring program for unregulated contaminants September 1999 UIC Class V study (judicial deadline) October 1999 Final determination on whether states have legal authorities or other means in place and are implementing to ensure new system capacity (for purposes of DWSRF withholding determination) UIC Class V rule (judicial deadline) December 1999 Promulgate rule on public notification 2000 January 1, 2000 Propose standard for arsenic August 2000 Promulgate a regulation for filter backwash recycling within the treatment process of a PWSS, unless addressed in SWTR Report to Congress on DWSRF transfer of funds Promulgate final radon standard (continued )

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TABLE 4.4

(Continued)

Conduct studies to identify subpopulations at greater risk and report to Congress October 2000 Determine whether states have met Sec. 1419 requirements related to capacity development strategy (for purpose of DWSRF withholding determinations) November 2000 Promulgate Final LT1 Enhanced Surface Water Treatment Rule Promulgate final rule on radionuclides (judicial deadline) Promulgate final rule on groundwater determining when disinfection is necessary (USEPA schedule) 2001 January 1, 2001 Promulgate final standard for arsenic February 2001 2nd Needs Survey Report to Congress 2nd Needs Survey for Indian Tribes August 2001 Determine state compliance with operator certification guidelines for purposes of DWSRF withholding Determine whether to regulate at least five contaminants from contaminant candidate list State Primacy Agencies Report to USEPA on success of enforcement mechanisms and assistance efforts in capacity development November 2001 States complete local source water assessments With Fiscal year (FY) 2003 Budget Report to Congress—evaluation of effectiveness of state DWSRF loan funds 2002 May 2002 Promulgate Stage II Disinfection Byproducts Rule (delayed) Promulgate LT2 Enhanced Surface Water Treatment Rule (delayed) Promulgate Phase II rule on UIC Class V wells September 2002 States submit publically available report to governors on efficacy of state capacity development strategy and progress in implementation 2003 May 2003 Extension deadline for states to complete local source water assessments August 2003 Propose MCLG and national primary drinking water regulation for any contaminant selected for regulation from contaminant candidate list 2005 February 2005 Final MCLG and rule for any contaminant selected for regulation from contaminant candidate list 3rd Drinking Water Needs Survey for States and Tribes

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security. On Dec. 11, 2001, Rep. Billy Tauzin (R–LA) introduced H.R. 3448 to improve the ability of the United States to prevent, prepare for, and respond to bioterrorism and other public health emergencies. On Dec. 20, 2001, the provisions of S. 1765, introduced by Sen. Bill Frist (R–TN) were incorporated into H.R. 3448. After consideration by both chambers, a conference committee was formed, that generate conference report H. Report 107-481. The conference report was passed by the House and Senate on May 22, 2002 and May 23, 2002, respectively. The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 was signed into law June 12, 2002, as Public Law 107-188. Title IV, Drinking Water Security and Safety, requires water systems to conduct vulnerability assessments, develop emergency response plans, and take other actions. Water system security provisions are reviewed in Chapter 24.

4.8

FUTURE OUTLOOK

The SDWA has been revised and rewritten since it was first enacted in 1974 to establish the federal program administered by USEPA to ensure safe drinking water in the Unites States. The text has grown and expanded to address unforeseen issues (Fig. 4.2) and provide authorization of federal funding to administer drinking water programs and provide for the DWSRF (Fig. 4.3). When funding authorizations end, reauthorization is needed, affording legislators an opportunity to make other revisions to the law. Infrastructure funding needs will continue to draw congressional attention. On April 11, 2002, the House Subcommittee on Environment and Hazardous Materials held a hearing on drinking water needs and infrastructure. A unique combination of social, scientific, and political forces shape the content of the SDWA. In this regard, it is no different than any other major piece of legislation passed by Congress. The SDWA will always be a work in progress, needing periodic amendments to meet current needs. In Chapter 5, the general U.S. govern-

Figure 4.2

Growth of the SDWA text.

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HISTORY OF THE SAFE DRINKING WATER ACT (SDWA)

Figure 4.3

Growth of SDWA authorized funding.

mental structure and legislative process are explained in more detail and the authorization and appropriations process discussed. The interplay of social, scientific, and political forces that have shaped the SDWA are explored. The forces of change and how those changes may shape future versions of the law are reviewed.

ACKNOWLEDGMENTS This chapter was adapted and updated from ‘‘The History of the Safe Drinking Water Act’’ prepared by the same author and published in the public domain by USEPA on the Agency’s Website for the SDWA 25th Anniversary, displayed during calendar year 1999.

REFERENCES ASDWA. 1993. Over $2.7 billion needed for SDWA infrastructure this year. ASDWA Update VIII:1. Auerbach, J. 1994. Costs and benefits of current SDWA regulations. J. Am. Water Works Assoc. 86:69. Auerbach, J. 1995a. Letter from J. Auerbach, USEPA OGWDW, to regulatory reassessment stakeholders. Regulatory Reassessment: Final Summary and Rankings, June 21, 1995. Auerbach, J. 1995b. Letter from Janet L. Auerbach, USEPA Drinking Water Standards Division, Washington, DC, to Fred Pontius, American Water Works Association. Denver, Aug. 22, 1995. Baker, M. N. 1981. The Quest for Pure Water, 2nd ed., Vol. I. New York: McGraw-Hill and American Water Works Association.

REFERENCES

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Bellar, T. A., J. J. Lichtenberg, and R. C. Kroner. 1974. The occurrence of organohalides in chlorinated drinking water. J. Am. Water Works Assoc. 66:12:703. BNA. 1995. BNA National Environment Daily. Drinking Water: More Time to Regulate Contaminants Requested by EPA, Agency Officials Say. Jan. 24, 1995. Washington, DC: The Bureau of National Affairs, Inc. Borchardt, J. A. and G. Walton. 1971. Water Quality. In Water Quality and Treatment, 3rd ed. New York: McGraw-Hill and American Water Works Association. Browner, C. M. 1993. Annual Conf., National Association of Towns and Townships, Washington, DC, Sept. 8, 1993. Carroll, B. 1993. Letter to state members and NRWA directors regarding SDWA reauthorization battle, Sept. 28, 1993. Center for Resource Economics 1993. Annual Review of the U.S. Environmental Protection Agency. Washington, DC: Center for Resource Economics. Cohen, B. A. and E. D. Olson. 1994. Victorian Water Treatment Enters the 21st Century. Washington, DC: Natural Resources Defense Council. Conacher, D. 1988. Troubled Waters on Tap: Organic Chemicals in Public Drinking Water Systems and the Failure of Regulations. Washington, DC: Center for Study of Responsive Law. Conference Report 104-741. Conf. Report on S. 1316, Safe Drinking Water Act Amendments of 1996. Congr. Record (House), pp. H9678–H9703, Aug. 1, 1996. Congressional Record. 1992. Congr. Record (Senate), pp. S15103, Sept. 25, 1992. Congressional Record. 1996. Conf. Report on S. 1316, SDWA Amendments of 1996. Cong. Record (H. Rept. 104-741), pp. H9678–H9703, Aug. 1, 1996. Congressional Research Service. 1982. A Legislative History of the Safe Drinking Water Act. Washington, DC: U.S. Government Printing Office. Congressional Research Service. 1993. A Legislative History of the Safe Drinking Water Act Amendments 1983–1992. Washington, DC: U.S. Government Printing Office. Cook, M. B. and D. W. Schnare. 1986. Amended SDWA marks new era in the water industry. J. Am. Water Works Assoc. 78:66–69. Cotruvo, J. A. and C. Wu. 1978. Controlling organics: Why now? J. Am. Water Works Assoc. 70:590. Craun, G. F. 1986. In Waterborne Diseases in the United States, G. F. Craun, ed. Boca Raton, FL: CRC Press. Dean, N. L. 1988. Danger on Tap, the Government’s Failure to Enforce the Federal Safe Drinking Water Act. Washington, DC: National Wildlife Federation. Dean, N. L. 1989. Update. Danger on Tap, the Government’s Failure to Enforce the Federal Safe Drinking Water Act. Washington, DC: National Wildlife Federation. Domenici, P. V. 1994. Domenici wants changes to Safe Drinking Water Act. Press release, March 24, 1994. Dyksen, J. E., D. J. Hiltebrand, and R. F. Raczko. 1988. SDWA Amendments: Effects on the water industry. J. Am. Water Works Assoc. 80:30–35. Gilbertson, W. E. 1989. Letter to the Editor. J. Am. Water Works Assoc. 81:4. Gray, K. F. and S. J. Koorse. 1988. Enforcement: USEPA turns up the heat. J. Am. Water Works Assoc. 80:47–49.

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Harris, R. H. and E. M. Brecher. 1974. Is the water safe to drink? Part I: The problem. Part II: How to make it safe. Part III: What you can do. Consumer Reports 436 (June), 538 (July), 623 (Aug.). Hembra, R. L. 1990. Compliance Problems Undermine EPA’s Drinking Water Program. Testimony before the Subcommittee on Environment, Energy, and Natural Resources. Committee on Government Operations. U.S. House of Representatives GAO=T-RCED90-97. Washington, DC: General Accounting Office. House Report 98-1034. Safe Drinking Water Act Amendments of 1984 (Sept. 18, 1984). Washington, DC: U.S. Government Printing Office. House Report 99-168. Safe Drinking Water Act Amendments of 1995 (June 11, 1985). Washington, DC: U.S. Government Printing Office. House Report 99-575. Safe Drinking Water Act Amendments of 1996 (May 5, 1986). Washington, DC: U.S. Government Printing Office. House Report 104-632. Safe Drinking Water Act Amendments of 1996 (June 24, 1996). Washington, DC: U.S. Government Printing Office. Kessler, C. and D. Schnare. 1991. A Section by Section Analysis of Comments on Safe Drinking Water Act Reauthorization (March 8, 1991). Prepared for the National Drinking Water Advisory Council. Washington, DC: USEPA Office of Ground Water and Drinking Water. Kyros, P. N. 1974. Legislative history of the Safe Drinking Water Act. J. Am. Water Works Assoc. 66:566. LCCA. 1988. Lead Contamination Control Act of 1988. Public Law 100-572, Oct. 31, 1988. Washington, DC: U.S. Government Printing Office. McDermott, J. H. 1973. Federal drinking water standards—past, present, and future. J. Envirn. Eng. Div.—ASCE EE4(99):469. NAS. 1977. Committee on Safe Drinking Water. Drinking Water and Health. Washington, DC: National Academy Press. NAS. 1980a. Committee on Safe Drinking Water. Drinking Water and Health, Vol. 2. Washington, DC: National Academy Press. NAS. 1980b. Committee on Safe Drinking Water. Drinking Water and Health, Vol. 3. Washington, DC: National Academy Press. NAS. 1982. Committee on Safe Drinking Water. Drinking Water and Health, Vol. 4. Washington, DC: National Academy Press. NAS. 1983. Committee on Safe Drinking Water. Drinking Water and Health, Vol. 5. Washington, DC: National Academy Press. NAS. 1986. Committee on Safe Drinking Water. Drinking Water and Health, Vol. 6. Washington, DC: National Academy Press. NAS. 1987a. Committee on Safe Drinking Water. Drinking Water and Health, Vol. 7. Washington, DC: National Academy Press. NAS. 1987b. Committee on Safe Drinking Water. Drinking Water and Health, Vol. 8. Washington, DC: National Academy Press. NAS. 1989. Committee on Safe Drinking Water. Drinking Water and Health, Vol. 9. Washington, DC: National Academy Press. NAS. 1993. Subcommittee on Health Effects of Ingested Fluoride. Health Effects of Ingested Fluoride. Washington, DC: National Academy Press.

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NAS. 1995. Subcommittee on Nitrate and Nitrite in Drinking Water. Nitrate and Nitrite in Drinking Water. Washington, DC: National Academy Press. NAS. 1997. Committee on Small Water Supply Systems. Safe Water from Every Tap: Improving Water Service to Small Communities. Washington, DC: National Academy Press. NAS. 1998. Committee to Evaluate the Viability of Augmenting Potable Water Supplies with Reclaimed Water. Issues in Potable Reuse: The Viability of Augmenting Drinking Water Supplies with Reclaimed Water. Washington, DC: National Academy Press. NAS. 1999a. Committee on Drinking Water Contaminants. Setting Priorities for Drinking Water Contaminants. Washington, DC: National Academy Press. NAS. 1999b. Identifying Future Drinking Water Contaminants. Washington, DC: National Academy Press. NAS. 1999c. Committee on Risk Assessment of Exposure to Radon in Drinking Water. Risk Assessment of Exposure to Radon in Drinking Water. Washington, DC: National Academy Press. NAS. 1999d. Subcommittee on Arsenic in Drinking Water. Arsenic in Drinking Water. Washington, DC: National Academy Press. NAS. 2000a. Copper in Drinking Water, Washington, DC: National Academy Press. NAS. 2000b. Re-Evaluation of Drinking Water Guidelines for Diisopropyl Methylphosphonate. Washington, DC: National Academy Press. NDWAC. 1993. Safe Drinking Water Act Reauthorization Issues. A Draft White Paper, April 13, 1993. NRC. 2001. Classifying Drinking Water Contaminants for Regulatory Consideration. Washington, DC: National Academy Press. Oleckno, W. A. 1982. The National Interim Primary Drinking Water Regulations, Part I— Historical Development. J. Environ. Health 44:5. Olson, E. D. 1993. Think before You Drink. Washington, DC: Natural Resources Defense Council. Olson, E. D. 1994a. Memo to the Heads of the NRDC, National Audubon Society, National Wildlife Federation, the Environmental Defense Fund, Friends of the Earth, and the Sierra Club Regarding SDWA Reauthorization, March 4, 1994. Olson, E. D. 1994b. Think before You Drink: 1992–1993 Update. Natural Resources Defense Council, Washington, DC, July 27, 1994. Page, T., E. Talbot, and R. H. Harris. 1974. The Implication of Cancer-Causing Substances in Mississippi River Water: A Report by the Environmental Defense Fund. Washington, DC. Page, T., R. H. Harris, and S. S. Epstein. 1976. Drinking water and cancer mortality in Louisiana. Science 193:55. Parmelee, M. A. 1994. NRDC report skews utility operations, goals. Mainstream 38(4):1. Pendygraft, G. W., F. E. Schegel, and M. J. Huston. 1979a. The EPA-proposed granular activated carbon treatment requirement: Panacea or Pandora’s box? J. Am. Water Works Assoc. 71(2):52. Pendygraft, G. W.; F. E. Schegel, and M. J. Huston. 1979b. Organics in drinking water: A health perspective. J. Am. Water Works Assoc. 71(3):118. Pendygraft, G. W., F. E. Schegel, and M. J. Huston. 1979c. Maximum contaminant levels as an alternative to the GAC treatment requirements. J. Am. Water Works Assoc. 71(4):174.

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Pontius, F. W. 1996. Overview of the Safe Drinking Water Act Amendments of 1996. J. Am. Water Works Assoc. 88:22–27, 30–33. Pontius, F. W. 1999. Complying with future water regulations. J. Am. Water Works Assoc. 91(3): 46–58. Ronnebaum, E. 1993. Letter to the Editor. USA Today (Sept. 29, 1993). Rook, J. J. 1974. Formation of haloforms during chlorination of natural water. Water Treat. Exam. 23:234–243 (Part 2). Schnare, D. W. 1990. Summary of Comments, Safe Drinking Water Act Implementation and Reauthorization Meeting. USEPA, OGWDW, Washington, DC, Sept. 26–27, 1990. SDWA. 1974. The Safe Drinking Water Act of 1974. Public Law 93-523, Dec. 16, 1974. Washington, DC: U.S. Government Printing Office. SDWA. 1977. SDWA Amendments of 1977. Public Law 95-190, Nov. 16, 1977. Washington, DC: U.S. Government Printing Office. SDWA. 1979. SDWA Amendments of 1979. Public Law 96-63, Sept. 6, 1979. Washington, DC: U.S. Government Printing Office. SDWA. 1980. SDWA Amendments of 1980. Public Law 96-502, Dec. 5, 1980. Washington, DC: U.S. Government Printing Office. SDWA. 1986. Safe Drinking Water Act Amendments of 1986. Public Law 99-339, June 19, 1986. Washington, DC: U.S. Government Printing Office. SDWA. 1996. Safe Drinking Water Act Amendments of 1996. Public Law 104-182, Aug. 6, 1996. Washington, DC: U.S. Government Printing Office. Senate Report 98-641. Safe Drinking Water Act Amendments of 1984. 98th Congress, 2nd Session. Sept. 28 (Legislative Day Sept. 24), 1984. Washington, DC: U.S. Government Printing Office. Senate Report 99-56. Safe Drinking Water Act Amendments of 1985. 99th Congress, 1st Session. May 15 (Legislative Day April 15), 1985. Washington, DC: U.S. Government Printing Office. Senate Report 104-169. Safe Drinking Water Act Amendments of 1995, Nov. 7, 1995. Washington, DC: U.S. Government Printing Office. Subcommittee on Health and Environment. 1985. Hearings before the Subcommittee on Health and the Environment of the Committee on Energy and Commerce, House of Representatives. Ninety-Ninth Congress, First Session. Safe Drinking Water Act Amendments of 1985—H.R. 1650. May 1, 1985. Serial No. 99-28. Washington, DC: U.S. Government Printing Office. Symons, G. E. 1974. That GAO Report. J. Am. Water Works Assoc. 66(5):275. Symons, J. M. 1974. Chlorinated Organics Workshop. In Proc. 2nd AWWA Water Quality Technology Conf. Denver: American Water Works Association (AWWA), Dec. 2–3, 1974. Symons, J. M. 1984. A history of the attempted federal regulation requiring GAC adsorption for water treatment. J. Am. Water Works Assoc. 76(8):34. Symons, J. M. 2001a. The early history of disinfection by-products: A personal chronicle (Part I). Environ. Eng. (Jan.). Symons, J. M. 2001b. The early history of disinfection by-products: A personal chronicle (Part I). Environ. Eng. (April). Symons, J. M., T. A. Bellar, J. K. Carswell, J. DeMarco, K. L. Kropp, G. G. Robeck, D. R. Seeger, C. L. Slocum, B. L. Smith, and A. A. Stevens. 1975. National Organics Reconnaissance Survey for Halogenated Organics. J. Am. Water Works Assoc. 67:634.

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The States-Item. 1974. Cancer victims could be reduced—deaths tied to New Orleans water. The States-Item 98(129):1, New Orleans, LA, Nov. 7, 1974. Train, R. S. 1974. Facing the real cost of clean water. J. Am. Water Works Assoc. 66:562. USA Today. 1993a. USA Today (Sept. 27, 1993). USA Today. 1993b. Water crisis? Well, sort of. USA Today (Sept. 30, 1993). U.S. Court of Appeals. 1978. Environmental Defense Fund v. Costle, No. 752224, 11 ERC 1214, U.S. Court of Appeals, D.C. Circuit, Feb. 10, 1978. U.S. Court of Appeals. 1995. Donison v. Browner, DC Ore, CV 92-6280-HO; Miller v. Browner, DC Ore, CV 89-6328-HO; Frohwerk v. Browner, DC Ore, CV 90-6363-HO, Citizens Interested in Bull Run v. EPA, DC Ore, CV 92-1587-MA; Frohwerk v. Browner, DC Ore, CV 91-6549-TC, Jan. 9, 1995. USEPA. 1972. Industrial Pollution of the Lower Mississippi River in Louisiana. Dallas, TX: USEPA Region VI, Surveillance and Analysis Division. USEPA. 1975a. New Orleans Area Water Supply Study. EPA Report EPA-906=9-75-003, Dec. 9, 1975. Dallas: USEPA. USEPA. 1975b. National Interim Primary Drinking Water Regulations. Fed. Reg. 40:59566– 59588. USEPA. 1976a. Promulgation of Regulations on Radionuclides. Fed. Reg. 41:28402–28409. USEPA. 1976b. Organic Chemical Contaminants; Control Options in Drinking Water. Fed Reg. 41:28991. USEPA. 1977. Recommendations of the National Academy of Sciences. Fed. Reg. 42:35764– 35779. USEPA. 1978a. National Organics Monitoring Survey. Cincinnati: USEPA Technical Support Division, Office of Drinking Water. USEPA. 1978b. Control of Organic Chemicals in Drinking Water. Proposed Rule. Fed. Reg. 43(28): 5756. USEPA. 1978c. Control of Organic Chemicals in Drinking Water. Notice of Availability. Fed. Reg. 43(130): 29135. USEPA. 1979. Control of Trihalomethanes in Drinking Water. Final Rule. Fed. Reg. 44: 68624. USEPA. 1980. Interim Primary Drinking Water Regulations; Amendments. Fed. Reg. 45:57332–57357. USEPA. 1981. Control of Organic Chemicals in Drinking Water. Notice of Withdrawal. Fed. Reg. 46:17567. USEPA. 1983. National Interim Primary Drinking Water Regulations; Trihalomethanes. Final Rule. Fed. Reg. 48:8406–8414. USEPA. 1993. Technical and Economic Capacity of States and Public Water Systems to Implement Drinking Water Regulations. EPA 810-R-93-001. Washington, DC: Office of Water. USEPA. 1994a. Report to the United States Congress on Radon in Drinking Water; Multimedia Risk and Cost Assessment of Radon. EPA 811-R-94-001. Washington, DC: Office of Water. USEPA. 1994b. Redirecting the Drinking Water Program. Draft. Office of Ground Water and Drinking Water. Washington, DC: Office of Water. USEPA. 1995a. Strengthening the Safety of Our Drinking Water. EPA 810-R-95-001. Washington, DC: Office of Water.

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USEPA. 1995b. Notice of Public Meetings on Drinking Water Issues. Fed. Reg. 60:10391– 10393. USEPA. 1995c. Public Meeting on Drinking Water, Consumer Awareness Project. Fed. Reg. 60:30538. USEPA. 1995d. Public Meeting on Drinking Water Paperwork Burden Reduction. Fed. Reg. 60:37894–37895. USEPA. 1995e. Comprehensive Drinking Water Program Redirection Plan Availability of Draft Document and Request for Comment. Fed. Reg. 60:61254. USEPA. 1995f. Drinking Water Program Redirection Proposal. A Public Comment Draft. EPA 810-D-95-001. Washington, DC: Office of Water. USEPA. 1996. National Drinking Water Program Redirection Strategy. EPA 810-R-96-003. Washington, DC: Office of Water. USGAO. 1990. Drinking Water: Compliance Problems Undermine EPA Program as New Challenges Emerge. GAO=RCED-90-127. Washington, DC: U.S. General Accounting Office. USGAO. 1992a. Drinking Water: Consumers Often Not Well-Informed of Potentially Serious Violations. GAO=RCED-92-135. Washington, DC: U.S. General Accounting Office. USGAO. 1992b. Drinking Water: Widening Gap between Needs and Available Resources Threatens Vital EPA Program. GAO=RCED-92-184. Washington, DC: U.S. General Accounting Office. USGAO. 1992c. Drinking Water: Projects that May Damage Sole-Source Aquifers Are Not Always Identified. GAO=RCED-93-4. Washington, DC: U.S. General Accounting Office. USGAO. 1993a. Drinking Water: Stronger Efforts Needed to Protect Areas around Public Wells from Contamination. GAO=RCED-93-96. Washington, DC: U.S. General Accounting Office. USGAO. 1993b. Drinking Water: Key Quality Assurance Program Is Flawed and Underfunded. GAO=RCED-93-97. Washington, DC: U.S. General Accounting Office. USGAO. 1993c. Drinking Water: States Face Increased Difficulties in Meeting Basic Requirements. GAO=RCED-93-144. Washington, DC: U.S. General Accounting Office. USGAO. 1994. Drinking Water: Small Systems. GAO=RCED-94-40. Washington, DC: U.S. General Accounting Office. USPHS. 1925. Report of the Advisory Committee on Official Water Standards. Public Health Rept. 40:693 (April 10, 1925). USPHS. 1943. Public Health Service Drinking Water Standards and Manual of Recommended Water Sanitation Practice. Public Health Reports 58:69 (Jan. 15, 1943). USPHS. 1946. Public Health Service Drinking Water Standards. Public Health Rept. 61:371 (March 15, 1946). USPHS. 1962. Drinking Water Standards. Fed. Reg. 2152–2155 (March 6, 1962). USPHS. 1970a. Community Water Supply Study: Analysis of National Survey Findings. Pb214982. Springfield, VA: National Technical Information Service. USPHS. 1970b. Community Water Supply Study: Significance of National Findings. PB215198=BE, Springfield, VA: National Technical Information Service. U.S. Statues. 1893. Interstate Quarantine Act of 1893. U.S. Statutes at Large, Chap. 114, Vol. 27, p. 449, Feb. 15, 1893.

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VanDe Hei, D. and T. Schaefer. 2002. SDWA: Looking to the future. In Drinking Water Regulation and Health, F. W. Pontius, ed. New York: Wiley. Wade, S. 1993. Letter to the Editor. USA Today (Sept. 30, 1993). Waterweek. 1994. Enviros charge utilities with treatment technology failures. Waterweek 3(7):7 (March 28, 1994). Waxman, H. A. 1994. The next water crisis. The Washington Post (Jan. 19, 1994). Westrick, J. J., J. W. Mello, and R. F. Thomas. 1984. The groundwater supply survey. J. Am. Water Works Assoc. 76:52.

5 SDWA: LOOKING TO THE FUTURE DIANE VANDE HEI Executive Director, Association of Metropolitan Water Agencies, Washington, DC

THOMAS SCHAEFFER Regulatory Specialist, Association of Metropolitan Water Agencies, Washington, DC

5.1

INTRODUCTION

A unique combination of social, scientific and political forces shape the content of the Safe Drinking Water Act (SDWA). In this regard, it is no different than any other major piece of legislation passed by Congress. The impact these forces have on any given piece of legislation can be convoluted and at times mystifying, but the legislative process itself is rather straightforward. It is prescribed by procedures established in the both the U.S. Senate and the U.S. House of Representatives. In this chapter, the general U.S. governmental structure and legislative process are explained and the authorization and appropriations process discussed. This will provide a framework for exploring how the interplay of social, scientific, and political forces have shaped the SDWA since it was first passed in 1974, building on the SDWA history provided in Chapter 4. Using that foundation, the forces of change and how those changes may shape future versions of the law are reviewed. 5.2

U.S. GOVERNMENTAL STRUCTURE

The structure of the U.S. government is truly unique. It is set forth by the Constitution of the United States, initially adopted on Sept. 17, 1787, and subsequently Drinking Water Regulation and Health, Edited by Frederick W. Pontius. ISBN 0-471-41554-5 # 2003 John Wiley & Sons, Inc.

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amended (Congress 1993). The United States is a federal, democratic republic, an indivisible union of 50 sovereign States. The government is at the local, state, and national levels ‘‘democratic’’ because the people govern themselves; ‘‘representative’’ because people choose elected delegates by free and secret ballot; and ‘‘republican’’ because the government derives its power from the will of the people. There are three primary branches of the U.S. government: the executive branch, the legislative branch, and the judicial branch, described briefly below, and fully detailed in the US Government Manual (GPO 2001).

5.2.1

The Executive Branch

The President of the United States is the administrative head of the executive branch of the government. The executive branch includes numerous agencies, both temporary and permanent, as well as 15 executive departments. The Cabinet is composed of the heads of the 15 executive departments (the Secretaries of Agriculture, Commerce, Defense, Education, Energy, Health and Human Services, Homeland Security, Housing and Urban Development, Interior, Labor, State, Transportation, Treasury, and Veterans Affairs, and the Attorney General). The U.S. Environmental Protection Agency (USEPA) is an independent agency under the executive branch, whose administrator is appointed by the President subject to confirmation by the Senate.

5.2.2

The Legislative Branch

All legislative powers are vested by the Constitution in a Congress of the United States that consists of a Senate and a House of Representatives. The Senate is composed of 100 members, 2 from each state, who are elected to serve for a term of 6 years. There are three ‘‘classes’’ of Senators, and a new class is elected every 2 years. The House of Representatives comprises 435 Representatives. The number representing each state is determined by population. Every state is entitled to at least one Representative. Members are elected by the people for 2-year terms, all terms running for the same period. The work of preparing and considering legislation is done largely by committees of both Houses of Congress. There are standing committees, select committees, joint commissions, special investigating committees, and joint committees. Table 5.1 lists the current (2002) committees of the U.S. Congress.

5.2.3

The Judicial Branch

Judicial power is vested by the Constitution in one Supreme Court, and in such inferior courts as the Congress may establish. The Supreme Court is composed of the Chief Justice and the number of Associate Justices as fixed by Congress,

5.3 HOW LAWS ARE MADE

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TABLE 5.1 Committees of the U.S. Congressa U.S. House of Representatives Agriculture Appropriations Armed Services Budget Education and the Workforce Energy and Commerce Financial Services Government Reform House Administration International Relations Judiciary Resources Rules Science Small Business Standards of Official Conduct Transportation and Infrastructure Veterans Affairs Ways and Means

U.S. Senate Agriculture, Nutrition, and Forestry Appropriations Armed Services Banking, Housing, and Urban Affairs Budget Commerce, Science, and Transportation Energy and Natural Resources Environment and Public Works Finance Foreign Relations Governmental Affairs Health, Education, Labor, and Pensions Indian Affairs Judiciary Rules and Administration Small Business Veterans Affairs

a Committee homepages and schedules can be accessed through THOMAS (http:==thomas.loc.gov=), a legislative information service on the internet provided by the Library of Congress and named after Thomas Jefferson.

currently eight. The President nominates the Justices with the advice and consent of the Senate. The United States is divided geographically into 12 judicial circuits, including the District of Columbia. Each circuit has a court of appeals, created to relieve the Supreme Court of having to consider all appeals in cases originally decided by the federal trial courts. 5.3

HOW LAWS ARE MADE

The making of a law in the United States requires both the House of Representatives and the Senate pass an identical act (bill), that the act receive final approval, and that the law be made known to the people who are to be bound by it. By far, the most demanding part of the process is the approval of identical legislation by both the House and the Senate. Figure 5.1 summarizes the federal legislative process. 5.3.1

How Legislation Originates

This legislative process starts with the thought that federal legislation is necessary in some areas. This thought may be very basic and unexplored, or it may take the form

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Figure 5.1

The federal legislative process.

of proposed legislation. The ideas for legislation may come from all corners, from individual constituents, citizens groups, business, state legislatures, industry, associations and similar groups, the administration, individual representatives, or combinations of these groups and others.

5.3.2

The Committee–Subcommittee Process

Once the idea is translated to legislative form and introduced by a sponsor in the House or Senate, the real action starts. Although the House and Senate procedures for considering and passing legislation differ greatly, they contain the same basic elements. The submitted bill is referred to a committee with jurisdiction over the subject matter for consideration. The committee, in turn, will normally refer the bill to one of its subcommittees. In the House, the bill or portions of it may be referred to a primary committee and one or more additional, secondary committees when the subject matter crosses committee jurisdiction. The committee process is perhaps the most important phase of a bill’s life. Many bills that lack support or general interest will languish in committee. For bills considered important, committees or subcommittees will meet to consider the bill and normally hold hearings to seek input from a variety of interested parties on the bill’s content. The committee or subcommittee may seek input from the U.S. General Accounting Office (USGAO) on the necessity for or desirability of the proposed

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109

legislation. Government departments and agencies affected by the proposed legislation will develop positions on the bill for committee consideration. These positions will be reviewed by the U.S. President’s Office of Management and Budget (OMB) for consistency with the President’s program prior to submission. After hearings, the committee or subcommittee will meet in what is called a ‘‘markup’’ session to put the bill into final form prior to voting on it. If handled in subcommittee, it will then go back to the full committee as written or as amended in the markup with a favorable, unfavorable, or no recommendation. The subcommittee can also recommend that the bill be ‘‘tabled’’ or held indefinitely. The full committee, when either acting on a bill itself or receiving a report from a subcommittee, will also consider the bill and hold a meeting to consider amendments. The full committee may report the bill back to the House or Senate with a favorable or unfavorable recommendation or hold the bill in committee. Both the House and the Senate have procedures for discharging a bill held by a committee if it is a bill of sufficient interest. 5.3.3

Floor Action on Bills

Bills sent back to the parent body are accompanied by a committee report that describes the purpose and scope of the bill, and a section-by-section analysis explaining the intent of the section. This ‘‘report language’’ is a significant part of the legislative history and is often used by regulatory agencies and courts in determining ‘‘the intent of Congress’’ once a bill becomes law. Reports are printed and available prior to further consideration of a bill. The next step for a bill reported from committee is normally consideration and debate before the House or Senate, although there are several ways to expedite the process on noncontroversial bills. After general debate, amendments are accepted, debated, and voted on. Finally, the measure as amended is voted on and approved or disapproved by the full body. The bill is then sent to the other house for consideration. The other house may have already been considering a companion bill or a similar measure or may take up the bill of the other house for consideration. In any event, after a similar process leading to a final or engrossed bill it is extremely unlikely that the House and Senate versions are identical. One body may choose to adopt the differences or changes in the bill of the other house. But working out differences between the two versions is normally handled through the Conference Committee process. 5.3.4

The Conference Committee Process

The fact that there is a bill from each house dealing with the same subject is not sufficient to start the conference process. One house must first amend and pass the bill of the other house and request a conference to work out differences. Often this amendment may be in the nature of substituting the entire bill from the other body with the bill as originally passed by the first. Once both houses agree to a conference, conferees are appointed and meet. The Conference Committee is limited to

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consideration of issues where differences exist and may not modify areas of agreement or add new subject matter. In most instances a compromise is reached between the two versions of the bill, and it is reported back to each house for action. In some cases where agreement cannot be reached, items in disagreement are reported back to each house, which may elect to agree with all or part of the other house’s actions. This may lead to several iterations of the Conference Committee process before each house has an identical bill to vote on. Once agreement is reached, a conference report detailing the actions of the committee in resolving differences is prepared. This report is also a key part of the legislative record. 5.3.5

Final Passage, Approval, and Publication

The bill becomes an enrolled bill after final approval by both houses and is ready for forwarding to the President. The debate each time a bill comes to the floor is captured in the Congressional Record, and becomes another key element in the legislative history. Each bill passed by Congress must be presented to the President for approval. The work of the Congress becomes law if the President signs it. The President has 10 days to sign passed legislation (excluding Sundays) or it becomes law without his signature. Within the 10 days, the President may veto the legislation by returning it to Congress with his objections. The act can still become law should the House and the Senate both override the veto by a two-thirds or higher vote. If the Congress adjourns during the 10-day period, the President is precluded from returning the bill with his objections, and it does not become law. This is known as a ‘‘pocket veto.’’ The first official publication of the statute is in the form known as the ‘‘slip law.’’ In this form, each law is published separately as an unbound pamphlet immediately after the law is approved. Each law is also published in the United States Statutes AtLarge, a collection of all laws passed by each session of Congress, and in the United States Code (USC), containing a consolidation and codification of general and permanent laws. As noted previously, this is a very simplified outline of how laws are passed. The procedures of both the House and Senate contain many nuances and differ greatly. House and Senate procedures are presented in Appendixes E and F, respectively. While some consider these procedures archaic, they have been developed over the years since the first Congress to ensure that laws receive full debate, that the views of the minority are aired, and that a standard of civility is maintained. 5.3.6

Authorization and Appropriation Measures

The authorization and appropriations process is derived from Senate and House rules that seek to bring discipline to the overall budget process. Laws such as the SDWA are authorizing measures; that is, they constitute the legislation that creates or continues an agency or program and authorizes the subsequent funding of those programs through the appropriations process. Authorizing legislation in the discretionary budget typically lays out funding for various programs for a 5-year period. Limiting the time on authorized funding is intended to ensure that programs are

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reviewed and updated on a continuing schedule or eliminated when no longer needed. Although the rules of both houses prohibit the appropriation of funds for programs that are not authorized, the prohibition is enforceable only through the raising of points of order in each body. Therefore, although a 5-year period may have been exceeded and no funds are authorized for subsequent years, Congress typically appropriates funds for important programs anyway. For instance, the 1986 Amendments to the SDWA authorized funding through fiscal year 1992, yet the bill was not reauthorized until the Amendments of 1996. Funds were appropriated annually regardless of the lack of authorization. Often, reauthorization of statutes will wait until there are sufficient driving forces to significantly modify the underlying law. Laws such as the annual Veterans Administration (VA), Housing and Urban Development (HUD), and Independent Agencies Appropriations bill, which provides funding for the USEPA, are appropriation measures; that is, they provide funding for programs previously authorized. Interestingly, appropriations for specific programs are frequently only a fraction of the amount called for in authorization legislation. For example, the 1996 Amendments to the SDWA authorized one billion dollars per year for State Revolving Loan Funds to assist water systems in complying with the Act. Funds appropriated for that purpose for the years following the Act’s passage have been in the neighborhood of three-quarters of that amount.

5.4

FORCES SHAPING THE SDWA AND AMENDMENTS

The SDWA was developed and driven by political, social, and scientific forces working in tandem. As discussed in prior chapters, federal involvement in drinking water standards stems from the Interstate Quarantine Act of 1893. The Act, among other things, authorized the director of the U.S. Public Health Service (USPHS) to make and enforce regulations to prevent the introduction, transmission, or spread of communicable disease between states. This authority was first used regarding drinking water in 1912, when regulations were issued banning the use of common drinking cups on interstate carriers. Through the early 1960s, the USPHS issued a variety of standards covering both microbial and chemical contaminants, including coliform bacteria, lead, arsenic, fluoride and sulfate. The standards were applicable only to water supplied to interstate carriers and placed no legal obligations on individual community water systems. Nevertheless, all states adopted, with few changes, the USPHS standards as state regulations or guidelines. 5.4.1

The Setting for the 1974 SDWA

Quoting Charles Dickens (A Tale of Two Cities): It was the best of times, it was the worst of times, it was the age of wisdom, it was the age of foolishness, it was the epoch of belief, it was the epoch of incredulity, it was the season of Light, it was the season of Darkness, it was the spring of hope, it was the winter of despair.

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Although Dickens could hardly have imagined the 1960s and 1970s in the United States, he was correct in his conclusion that his characterization of the age of the French Revolution, the setting for his novel, was no different from his own time or, indeed, any time. Nevertheless the two decades marking the last years of the industrial era and the beginnings of the information era were quite remarkable and shaped the formation of the original SDWA. The period witnessed the Apollo program resulting in the first person on the moon, and the nationally divisive war in Vietnam. It held the civil rights movement as well as the shift of the conservation ethic to environmental activism. The period marked the height of the Cold War, and the Watergate scandal. It witnessed the beginning and growth of the Women’s Movement and the Great Society programs intended to ensure that the less fortunate in American society were provided a safety net as well as help for the future. The period contained near its beginning the Cuban Missile Crisis, and at its end the Arab Oil Crisis. The year 1974 marked a year that would significantly change the Congress. That year 75 freshmen Democrats were elected to the U.S. House of Representatives. The ‘‘Class of 1974’’ was far more activist and liberal than the Democrats in the House, particularly the leadership. The freshmen led a revolt against that leadership displacing several powerful committee chairmen, transferring many of the leadership’s prerogatives to the Democratic Caucus, and setting up the now familiar subcommittee process to spread the power base. Where once the administration or lobbyists had to deal only with the House leadership and the heads of committees to affect legislation, now it was necessary to deal with the House almost on a member-by-member basis. This weakening of the old lobbying links opened the door for political advocacy organizations and political action committees (PACs) and their contributions. The Class of ’74 is still playing a major role in directing environmental legislation implementation through oversight functions and in subsequent environmental law development and reauthorization. The postwar boom provided individuals with both an overall prosperity and an increase in leisure time. Additionally, it was during this period that the baby boom generation was moving through college or into the workforce. The activism of the period, if not engendered solely by this group, had a lasting impact on their thoughts and values. In short, it was a time ripe for political activism, an activism that called into question the previous general faith in the government and its leaders. In this regard, it mirrored Dickens’ observation. At the same time there was declining faith in the ability of government to solve problems, there were increased demands for government to step in with federal solutions. It was also a time of remarkable technological achievement. Of these, perhaps the most important were those that paved the way for the information era to grow and accelerate. The transistor came into commercial use and was quickly outdated by the integrated circuit and microchip. Apple developed the first personal computer. The space program paved the way for communications satellites. And the military, through the Advanced Research Projects Agency (ARPA), developed ARPA net, the precursor to the Internet, email (electronic mail), and the World Wide Web. The space program paved the way for communications satellites, and the fax (Facsimile) machine was commercialized.

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On the environmental front, the country suffered from the effects of the post– World War II industrial boom. One did not need to take air or water samples and look for contaminants in parts per billion concentrations. Individuals in large cities could see and smell the effects of air pollution. People could see and touch lakes, rivers, and streams with surfaces covered by petroleum products and other industrial wastes. Many waters, including Lake Erie, were reported to be dead zones or were quickly approaching that point with little aquatic life and numerous, massive fish kills. It was during this time that the Cuyahoga River was so polluted by industrial wastes that it burst into flames from spontaneous combustion; in 1961, the World Wildlife Fund was formed; in 1961, the Environmental Defense Fund; and in 1970, the Natural Resources Defense Council. Science added to the obvious signs of pollution, detailing invisible and heretofore immeasurable threats of heavy metals, radiation, hydrocarbons, pesticides, and chlorinated solvents. In 1962, Rachel Carson published Silent Spring, an indictment of pesticide use that caught the imagination of both the public and the press and became a national bestselling book. The 1960s witnessed the growth of local, grassroots organizations dedicated to solving local pollution problems. With the growth of these groups in number and size, media coverage of environmental issues increased on the local and state levels, bringing with it an increase in local and state action. Nevertheless, concern over the environment failed to rise to a national political level until the end of the decade. One national politician, Gaylord Nelson, then Senator from Wisconsin, had taken notice of environmental pollution and conceived of a national ‘‘teach-in’’ to raise environmental awareness and promote the issue to the national political level. The first Earth Day, which grew from his vision and work, succeeded far beyond what he could have imagined. On April 22, 1970, an estimated 20 million people gathered for Earth Day teach-ins, rallies, speeches, and protests. So anxious were members of Congress to be part of the action that Congress was adjourned for the day. This one event raised the environment to a national political issue almost overnight. The time marks the transition of the conservation movement and its organizations to more general environmental concerns as well as the birth of numerous new national and local environmental groups. In rapid succession, then-President Nixon proposed and formed the USEPA, the Council on Environmental Quality and the National Oceanic and Atmospheric Administration. Congress was exceptionally prolific, passing the National Environmental Policy Act; the Clean Air Act; the Resource Conservation and Recovery Act; the Federal Water Pollution Control Act; the Noise Control Act; the Marine Protection, Research and Sanctuary Act; the Federal Insecticide, Fungicide and Rodenticide Act; the Endangered Species Act; the Coastal Zone Management Act; the Port and Waterways Safety Act; and the Marine Mammal Protection Act. USEPA Administrator Russell E. Train characterized this progress in a 1975 address, ‘‘Never before in history has a society moved so rapidly and so comprehensively to come to grips with such a complex set of problems.’’ This legislation resulted from a bipartisan effort in Congress driven by broad public consensus that environmental laws were needed. This consensus included many leaders in business and industry who would later rethink their support as the laws were turned to regulations that affected their bottom line.

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It was in this setting that the SDWA took form. As awareness grew through the 1960s of the impacts of industrial pollution and agricultural pesticide runoff, concern mounted over what impacts this contamination would have on drinking water drawn from polluted sources. A series of federal studies was undertaken to explore the issue. Perhaps the most important from the point of view of driving later legislation was the 1969 Community Water Supply Study by the USPHS, discussed in Chapter 4. The study found that bacterial and chemical contamination of community drinking water was widespread, particularly in small communities. Only 60% of systems checked met the few standards then in effect. The study also found that monitoring was rarely practiced and that the quality of state supervision varied greatly from state to state. The SDWA (Public Law 93-523) was passed in 1974 in response to the public and congressional concern, and preceding chapters have expanded on this early history. As USEPA proceeded to implement the law, the agency made significant progress in advancing the state of the science on all fronts. But not surprisingly, few major regulations were issued through the mid-1980s other than the interim standards based on USPHS work. 5.4.2

The Setting for the 1986 Amendments

Quoting Douglas M. Costle, USEPA Administrator, in the Carter administration: What does a reasonably prudent person do in the face of scientific uncertainty? The answer is: You take reasonable precautions. That is the essence of many EPA decisions. But it is not, unfortunately, how most of these laws are written.

Although the SDWA was amended in 1977, 1979 and 1980, few significant changes were made. The first major revision came in 1986. The 1986 amendments are often said to have been a reflection of dissatisfaction in Congress over the small number of contaminants USEPA had managed to regulate since 1974. But much more was going on. The Oil Embargo at the end of the 1970s was a major national crisis. Fuel shortages and price controls were the order of the day. It was a time of doubledigit inflation and interest rates over 20%. The energy industry was called on to develop alternative sources of energy and reduce dependence on foreign oil. The industry complained that environmental regulations severely impeded their ability to do so. This theme was adopted by other businesses and industries and expanded to the sound bite that overregulation was strangling the American economy. Although the goals of environmental and consumer legislation had been accepted by many leaders in these sectors during the 1970s, they were less enchanted when the goals were translated into required actions and expenditures through specific regulations. Even though the regulatory impact was small compared to that caused by the overall economic climate, calls for regulatory relief came from all sides. The breakdown of the old lobbying links that started with the changes in the House of Representa-

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tives’ committee structure led to a boom in businesses and industry establishing offices in Washington, DC, hiring lobbyists and forming associations to make sure that their views were heard by Congress and the administration. In 1980, Ronald Reagan was elected President, promising both an economic turnaround and regulatory reform in his platform. Shortly after taking office, he signed an Executive Order requiring a cost=benefit analysis be submitted to OMB for review with each new proposed regulation. This Executive Order had no direct effect on environmental regulations because few of them allowed considerations of costs in establishing standards. But it had the indirect effect of making USEPA look for cost-effective solutions. The administration pursued regulatory reform so strongly that its efforts paradoxically ensured that little real reform would take place. Environmental groups were energized by the administration’s efforts, which they characterized as attempts to undo environmental protection. The ranks of these organizations grew dramatically, as did the amount of donations they received. The groups used public relations campaigns to focus public opinion against any changes in environmental laws. Although such groups were initially on the defensive against the administration, their efforts within a few years put the administration on the defensive. Two administration appointments aided this effort. Interior Secretary James Watt and USEPA Administrator Anne Burford, became lightening rods for environmental forces because of their approach to deregulation and past statements and actions on environmental issues. The two were subjected to intense scrutiny by House environmental subcommittees, and were, rightly or wrongly, demonized by the media. Both eventually resigned from their positions. The combination of all these forces turned the administration’s regulatory reform into regulatory retreat. Additionally, throughout this period, public support for protecting the environment remained strong. It was in this setting that the 1986 Amendments to the SDWA were considered. Congress, particularly the environmental subcommittees, had expected USEPA to accomplish more in the way of regulating contaminants. By 1986, only 23 contaminants were regulated. The majority of those were interim standards based on the USPHS standards in existence prior to 1974. Although blamed for not developing more standards, USEPA had not been idle during the period. The agency completed the National Organics Reconnaissance Survey in 1975, the National Organics Monitoring Survey (1976=77), the National Screening Program for Organics (1977–1981), and the Ground Water Supply Survey (1980=81). These surveys focused on chemical contamination, continuing the focus of the 1974 law and the perceived public health threat of these contaminants. The House Energy and Commerce and Senate Environment and Public Works Committees led the 1986 reauthorization of the Act. In the House, members of the environmentally active Class of ’74 now held senior positions in these committees and subcommittees. After their battles with the Reagan administration over regulatory reform, the Class of ’74 wanted to ensure that the administration had little flexibility to delay regulations. In addition, moderate House Republicans were not eager to jump on a failing regulatory reform effort, nor did they want to add to the Democrats’ reelection advantage. Democrats and Republicans joined forces, vowing

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that neither party would accept an amendment to the SDWA that the other did not agree with. The Senate Committee united in much the same way as the House, working to rein in the administration’s regulatory flexibility. The Senate, generally proenvironmental, with proenvironmental Republicans on the environmental committees, more than compensated for other Republican members following the administration’s lead on regulatory reform. It was no surprise then that the Congress passed the 1986 SDWA Amendments by overwhelming majorities and that the most significant changes were to provide little flexibility for USEPA in pursuing contaminant standards. Nor was it a surprise that the President approved the legislation. That approval was driven, at least in part, by the need for the administration to dispel the negative effects of appearing antienvironmental, but mostly by the overwhelming (veto-proof) majorities by which the law passed both Houses. Ironically, it was also during this time period that USEPA solidified its policy establishing a health goal of zero for carcinogens in drinking water. This policy stood unchallenged until 1999, when USEPA proposed a goal other than zero for chloroform—a known human carcinogen. The 1986 law was very prescriptive to the point of limiting even the use of common sense on contaminants that did not need regulation. This overkill would later drive changes in the 1986 Amendments. Among other requirements, the 1986 law specified 83 contaminants to be regulated in stages by 1989 (with limited ability to substitute up to seven other contaminants with greater health risks). The USEPA Administrator at the time had advised Congress against pursuing this path, noting that doing so would preempt decisions based on good scientific evidence and could lead to unsound and unwarranted regulations. The amendments also required USEPA to establish a list of potential drinking water contaminants by 1988 and to regulate at least 25 of them by 1991. The list was to be regularly updated, and USEPA was required to regulate an additional 25 contaminants every 3 years starting in 1994. The 1986 Amendments to the Act also required USEPA to promulgate regulations requiring disinfection as a treatment technique for all public water systems, and to establish criteria under which surface water systems would be required to filter. 5.4.3

The Setting for the 1996 Amendments

The USEPA Science Advisory Board (USEPA 1990) stated that There are heavy costs involved if society fails to set environmental priorities based on risk. If finite resources are expended on lower-priority problems at the expense of higher-priority risks, then society will face needlessly high risks. If priorities are established based on the greatest opportunities to reduce risk, total risk will be reduced in a more efficient way, lessening threats to both public health and local and global ecosystems.

Environmental groups continued to grow in strength after passage of the 1986 Amendments until the William Clinton presidency, at which point their membership

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declined, perhaps driven by the perception that a Democratic president would take care of environmental issues. Contrary to expectations, the entire issue of regulatory reform, which saw so little movement during the Reagan–Bush years, would resurface with a vengeance. The public was still concerned about the environment, but with the end of the Cold War, began looking inward at other social problems. Although the environment remained a national issue, it ranked far behind the economy, Social Security, healthcare, and education in the minds of the public and consequently Congress. USEPA’s policy in implementing the 1986 Amendments was that it was prudent to err on the side of safety in the face of insufficient scientific data for a clear-cut decision. The policy was tempered by the need for agency actions to be scientifically and legally defensible as well as technically and economically feasible. On one hand, not ensuring a minimum scientific basis for standards would lead to lawsuits; on the other, requiring communities to expend funds far in excess of any reasonable benefit or for no known benefit at all would lead to a backlash against the entire drinking water program. Working within these constraints led to delays in meeting the Act’s deadlines, resulting in lawsuits by environmental groups over missed deadlines. When USEPA did issue regulations in the early 1990s for the bulk of the 83 contaminants specified by Congress, the USEPA Administrator noted in press releases that, for most of the contaminants, the common factor was that they rarely occurred in drinking water and seldom at levels of public health concern. Even though this was true, water systems were required to monitor for the contaminants. To the surprise of many, these monitoring requirements, which were particularly expensive for small water systems, would prove to be one of the driving forces in the 1996 reauthorization effort. In the early 1990s, the issue of unfunded federal mandates came into focus. The genesis of the issue was both a reduction in federal grants to states and localities since the early 1990s coupled with an ever-growing list of federal requirements for state and local governments to spend money on programs mandated by Congress. Effectively, those officials saw increasing proportions of their budgets dedicated to federal requirements reducing their discretion to deal with local problems they considered more pressing. Organizations representing state and local governments prepared a number of studies detailing costs and lack of flexibility of various regulations. A typical study would describe programs or services that cities had to forego because of mandated programs, as well as listing requirements they deemed had minimal, if any, benefit. Some reports went on to contend that resources taken from local governments to meet mandates actually increased risks to public health and safety because of higher-priority programs that could not be funded. Drinking water programs were typically included in the studies because of the regulations governing chemicals that were rarely found. The organizations and the cities and states themselves took their issue to Congress, calling for mandate relief, through either additional financial assistance, fewer requirements, or greater flexibility in implementing laws and regulations. The unfunded mandates issue also generated political awareness of benefit-cost considerations. One way to reduce regulatory burdens is to ensure that the benefits of

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regulation are justified by its costs. Additionally, proponents of benefit-cost considerations believed that its use would help ensure that the most important priorities were addressed first—those where states and localities could get the most ‘‘bang for the buck.’’ Another related issue was that of risk assessment. In order to develop the benefits side of benefit-cost equations, risk assessment was a necessary part. However, risk assessment can employ many assumptions or conservative default positions. This, in turn, led to calls for the use of sound science in developing regulations. Environmental regulations, which had first targeted business and industry, now were impacting not only states and localities but also individuals. This impact on individuals, particularly in their use of property, led to calls for government compensation to address ‘‘takings.’’ In the early 1990s, regulatory reform was defined as addressing the three issues just discussed: unfunded mandates, risk and benefit-cost analysis, and takings. Environmental groups began calling the three the ‘‘unholy trinity,’’ reflecting their concerns that these issues were merely being used as an excuse to roll back or ‘‘gut’’ environmental protections. Although such groups had outlined their issues for the Clinton administration including elevating USEPA to Cabinet status, addressing nonpoint sources of water pollution, dealing with environmental justice issues, and fostering ecosystem management, the ‘‘unholy trinity’’ argument put them on the defensive. The calls for regulatory reform were bipartisan in nature. They came from Republican and Democrat governors and mayors alike and the administration and Congress took notice. There were numerous bills addressing regulatory reform during the Bush administration at the beginning of the 1990s and throughout the following Clinton administration. The Clinton administration, which took office in 1993, expressed sympathy for the issue and made it a part of their program of ‘‘reinventing government.’’ One of the administration’s key efforts on the environmental front was elevating USEPA to Cabinet status. This effort was derailed in Congress by efforts to add risk and benefit-cost considerations to USEPA’s governing legislation. Environmental groups considered the threat of incorporating these issues so great that they dropped elevating USEPA as an issue, and it did not come up again during the two terms of the administration. Also at the beginning of the Clinton administration, there were a number of environmental laws, including the SDWA, that were due for reauthorization. The debate over inclusion of risk and benefit-cost considerations as well as the other regulatory reform issues in these statutes resulted in no action being taken despite Democratic control of the House and White House. Missteps by the Clinton administration, particularly over healthcare reform, and frustration that nothing was getting done in Congress, left an opening for Republicans in the 1994 Congressional elections. After 40 years of being in the minority, Republicans took power in the House. Republicans responded with their ‘‘Contract with America,’’ a list of 10 major issues they proposed for passage within the first 100 days of taking power. Phase II of the regulatory reform movement was about to begin.

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In a virtual replay of the first years of the Reagan administration, the Republicans pressed their agenda very hard and very fast solidifying opposition on the Democratic side. Even regulatory reform, which had been a bipartisan issue, became partisan. Once again the approach to regulatory reform virtually assured that little real reform would take place. For example, the Republicans were able to pass the Unfunded Mandates Reform Act of 1995. Although the Act purports to deal with limiting Congress’ ability to place unfunded mandates on States and localities, in reality even if the requirements of the statute are invoked a simple majority vote by Congress is all that is needed to impose such mandates. During the early 1990s, problems with the 1986 Amendments began to surface. Small systems compliance problems increased as the number of regulated contaminants grew. Additionally, the fact—acknowledged by USEPA—that contaminants were being regulated that seldom occurred in drinking water and rarely at levels of public health concern added fuel to the fire. Paradoxically, USEPA was having a great deal of trouble regulating those contaminants that did occur in drinking water at levels of public health concern such as radon, arsenic, and the radionuclides. This was both because these regulations would involve significant costs to a large number of communities and because the science underlying any regulatory level was unclear. In the case of radon, concerns with regulating the generally very low levels that occurred in drinking water—low even when compared to ambient outdoor air levels—led Congress to write language into the fiscal year 1994, 1995, and 1996 USEPA appropriations bills prohibiting the agency from issuing a regulation. Another problem arose from the focus of the 1974 Act and the 1986 Amendments on chemical contaminants. As the agency began to focus on regulation of disinfectants and disinfection byproducts in the early 1990s, it realized that steps taken by water systems to reduce byproducts, such as reducing levels of disinfectant used, could effectively reduce microbial protection. The agency characterized this as a risk–risk tradeoff situation, which was not covered by the SDWA. In fact, the Act would require the reduction of the chemical pollutants regardless of the introduction of countervailing risks. Additionally, there was a great deal of scientific uncertainty surrounding the health effects of disinfectants and disinfection byproducts. Accordingly, USEPA looked for an innovative way to address the problem, settling on negotiating a regulation through the Federal Advisory Committee Act (FACA) process. The Federal Advisory Committee that was formed consisted of representatives from the drinking water community as well as from environmental and consumer groups and state and local governments. This group provided a forum that underscored shortcomings in the Act, including the risk–risk tradeoff issue, the lack of overall flexibility in the Act and the need to consider risk and cost-effectiveness of regulations. Additionally, another, but related problem, arose from the way standards were required to be set. The 1986 Amendments required USEPA to set maximum contaminant levels (MCLs) as close to maximum contaminant level goals (MCLGs) as feasible. Very little flexibility was allowed in considering relative costs and benefits at different MCL levels. MCLGs for suspected carcinogens were routinely set at zero

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with the corresponding MCL set at the limit dictated by analytical measurement method capability. Many in the drinking water community feared that as analytical measurement capability improved, MCLs would constantly be lowered with no brake on the process. They knew that chasing zero would eventually become very expensive as lower and lower standards caused shifts to more expensive technologies, and that reasonably a point would be reached where any theoretical marginal benefit of the reduction would be minimal. They believed that consideration of incremental benefits and costs, as different regulatory levels were considered, would help inform USEPA’s risk management process and lead to more appropriate regulatory decisions. During this same time period, environmental groups sued USEPA for failure to meet statutory deadlines, and states became increasingly vocal about the expense of retaining primacy over the drinking water program. USEPA worked with the courts to extend deadlines and with the states to set priorities, but pressure to reform the 1986 Act was at an all-time high. It was in this context that the 1996 Amendments were considered. The Act was modified in 1988, but like the 1977, 1979 and 1980 changes, the modifications were incremental in nature. In this case, a requirement to recall lead-lined water coolers found in schools was added. After that, a number of SDWA reauthorization bills making significant changes were submitted but none were seriously considered until 1994. During 1994, both the House and Senate worked on legislation to reform the SDWA only to fail when Congress adjourned sine die on October 7 to campaign for the upcoming elections. The final days of the 103rd Congress provide a glimpse into how social and political forces can collide, bringing Congress to a standstill. On September 27, 1994, the House leadership blessed a plan to send the Safe Drinking Water Act Amendments of 1994 (H.R. 3392) to the floor on the Suspension Calendar. Since the Democratically controlled House did not want to go to a formal conference with the Senate because its bill contained risk assessment provisions, the USEPA Cabinet status bill and unwanted ‘‘property takings’’ language, the House chose to pursue a ‘‘take it or leave it’’ strategy. Rather than stripping S. 2019 of its content and sending it back to the Senate with the House bill inserted, the House simply passed its own bill, H.R. 3392, exactly as reported out of committee. By following this course of action, the House ensured that if the Senate wanted to reauthorize the SDWA in the few days remaining in the session, their only choice was to pass H.R. 3392 as its own. However, the Senate responded by attempting to ‘‘hotline’’ its own bill. The Senate stripped S. 2019 of the Cabinet bill, risk assessment, and property takings language, hoping to get it to the Senate floor on the consent calendar on Friday, September 30. The effort was unsuccessful. Not willing to call it off, Senate staff worked over the weekend to redraft S. 2019 incorporating many of the House provisions. Their only hope was to craft a bill that had complete agreement by all senators. In the end, the bill never made it to the Senate floor. For very different reasons, members of the Class of ’74 and regulatory reform proponents worked to defeat the measure not willing to concede the SDWA as a vehicle for pursuing their political agenda in the next Congress. In this way, the SDWA reauthorization debate moved to 1995 and a new Congress.

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Pressure to reform the SDWA continued in 1995. In that year, both the House and Senate passed separate SDWA reauthorization bills, but the bills did not make it to conference before the end of the session. The House and Senate finally passed and reconciled bills in 1996. The final bill was supported by the Administration and signed by the President. It was also supported by the water supply community, state and local governments, and environmental groups. The 1996 amendments contained many compromises arising from the need for a bipartisan bill. Nevertheless, it marked a significant departure from past versions and from most other environmental statutes by allowing consideration of costs and benefits in setting standards, provisions to improve the scientific basis of decisions, and a State Revolving Loan Fund (SRLF) to provide loans and grants to systems needing to make improvements under the Act. 5.4.4

The Setting for the 2002 Amendments

Following the terrorist attacks of September 11, 2001, Congress and the Administration devoted themselves to security issues. Hearings were held, legislative proposals were introduced. At issue was how well prepared were U.S. agencies to prevent and respond to future terrorist activity. The water industry, USEPA, and the Centers for Disease Control had been working on security issues in general, and specific to drinking water supplies, for several years prior to 2001. This activity greatly accelerated, with additional funding and attention given by USEPA. Attention to potential threats to drinking water systems began to increase following the posting of a series of articles on the Internet by MSNBC in January 2002, which included a complete vulnerability analysis of threats to water systems. The public, the administration, and bipartisan Congressional concern for security in the broadest sense, including water supplies, provided the context for the Public Health and Bioterrorism Prevention and Response Act of 2002, discussed in Chapter 24. As mentioned below, ensuring water system security will continue to be a significant force shaping the SDWA. 5.5

FUTURE AMENDMENTS TO THE SDWA

As in the past, future Amendments to the SDWA will be driven by political, social, and scientific forces working in tandem. Although each force is complex on its own, any combination of factors could lead to innumerable future outcomes. Nevertheless, some general conclusions can be drawn from the past and some potential future directions projected. 5.5.1

Political Dimension

Political forces that shaped the early SDWA and its reauthorization discussed above provide insight about why those laws took the form they did. Because of the way the U.S. government is structured and the way laws are made in the United States, defeating proposed legislation is far easier than passing it. Measures that do survive to become laws are typically the products of bargaining and compromise involving not only legislators and the administration but also interest groups.

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Environmental legislation, in particular, is seldom considered unless there is significant public support and demand for action. Laws normally evolve in incremental steps such as those seen in the 1977, 1979, 1980, and 1988 Amendments to the SDWA. In general, major changes to laws, such as those seen in the 1986 and 1996 Amendments, are relatively rare since they require an urgency for immediate action and strong public and bipartisan support. The Public Health Protection and Bioterrorism Prevention and Response Act of 2002 is a notable exception. Public concern over security of public water supplies and other public health measures in the aftermath of the Sept. 11, 2001, terrorist attacks on the United States drove bipartisan support and congressional action. The original 1974 Act was drafted in an era when the need for action on the environmental front was clear, and the Act had strong bipartisan support. The same Republican Nixon administration that formed the USEPA strongly supported the SDWA crafted by a House and Senate controlled by Democrats. The 1986 Amendments were as much a reaction to the Republican Reagan administration’s overreaching on regulatory reform in environmental areas as frustration with USEPA’s progress in issuing regulations. Its restrictiveness in specifying specific contaminants to be regulated and unrealistic timeframes for regulation, however, contained within it the seeds of its ultimate failure. The 1996 Amendments were driven by a series of implementation problems in the 1986 law and shaped by a bipartisan call from states and municipalities for a more rational, cost-effective way to approach environmental regulations. The 2002 Amendments embodied in the Public Health Protection and Bioterrorism Prevention and Response Act of 2002 were clearly driven by public concern over security of public water supplies and other public health measures in the aftermath of Sept. 11, 2001. Security concerns will likely shape Congressional initiatives and action for many years to come. Currently (2002) political campaigns for the 2002 midterm Congressional elections are beginning to gear up. Historically, midterm elections have turned against the party holding the White House, with seats held in Congress increasing for the party seeking to take the presidency in the next presidential election. Speculation is high regarding potential shifts in the balance of power within the U.S. Congress. Recent (at the time of writing) corporate scandals as well as difficult economic times will have an unmistakable impact on the 2002 midterm elections, as well as any future amendments to the SDWA.

5.5.2

Social Dimension

In order for an issue to demand political attention of the type leading to a new law or major amendments to existing law, it must rise to national prominence. To do this, it must become an issue in the eyes of the public and lead to public support for action. Public demand sometimes happens on its own, but more often is generated through special interests. Crisis situations compel Congress, the administration and even special interests to work together toward a solution. Issues, without crisis, grind

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slowly through the process in search of support and often languish until a driving force (whether political or social) arises. For most environmental laws, the political power of environmental groups acts as a counterbalance to business and industry groups. In the case of the SDWA, the majority of the entities affected are states and municipalities, not business and industry. The political dynamics between environmental groups and public entities is often less harsh than with private industry, since they may share common goals although at times very different approaches. Major tensions between the groups arise more often over the details of protecting public health rather than the overall objective. Environmental groups strongly supported the 1986 Amendments with their emphasis on little flexibility and strict deadlines. Much of the power of environmental groups is gained through the enforcement of environmental laws through the courts. Through settlements, they have a say in the final schedule for regulations and, at times, portions of their content. Environmental groups have also sought to increase their power by promoting access to the regulatory process in environmental laws. The most obvious legal provisions are those that allow citizen suits under the various statutes. The public since the 1960s has increasingly identified themselves as supporting efforts to improve the environment, and today the vast majority of people do so. However, in specific cases, that general support may depend on who pays for improvements, where facilities to address pollution are located, and the degree of impact on an individual’s lifestyle. For example, the majority of those identifying themselves as environmentalists do not choose to drive the most fuel-efficient cars. Most environmental statutes approach the ‘‘who pays’’ issue from the ‘‘polluter pays’’ point of view. The public has generally supported these laws even when realizing that costs may eventually be passed to consumers through higher costs for goods and services. The public has also supported environmental improvement efforts funded by income tax or other general revenues. Support has not been as strong when costs must be borne directly by individuals. Rate increases to be borne by consumers for water and wastewater are often opposed. Opposition has also been seen when facilities need to be built to meet environmental requirements. Although the public generally supports such facilities they have resisted having such facilities located near them. The ‘‘not in my backyard’’ (NIMBY) phenomenon is a further indication that the environment is a priority as long as efforts to improve it do not significantly impact an individual’s lifestyle. Additionally, support for the environment as a national issue tends to vary as general economic conditions vary with support decreasing in worsening economic conditions. Overall, support for environmental efforts appears to be very broad, but not necessarily very deep. 5.5.3

Scientific Dimension

Although an important factor, science has taken a back seat to political and social forces in shaping the SDWA. The 1974 Act included few provisions related to

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science. The 1986 Amendments tended to ignore the improvements in the science of risk assessment that had developed since passage of the 1974 Act. The Act’s requirement to regulate a specific list of contaminants regardless of their public health implications is testament to a lack of trust in science or those who would use it. Incorporation of science provisions in the 1996 Amendments was less a recognition by Congress of the importance of scientific and technical issues than a desire to deal with the problem of costs, particularly to small systems. In the face of bipartisan criticism that regulation of congressionally specified contaminants without regard to costs or benefits did not make sense, inclusion of provisions for the use of ‘‘good science’’ became a political necessity. Consideration of the political, social, and scientific forces involved in shaping the SDWA over more than three decades indicates that future changes to the SDWA are likely to be incremental in nature. This is the way laws normally evolve. Environmental groups are likely to oppose any tightening of the now mostly discretionary cost=benefit provisions of the law or the still very general scientific provisions. States and communities are likely to oppose any weakening of these provisions as well as any major changes to the overall regulatory process. Major crisis situations that may develop are likely to involve only one contaminant. If these are addressed at all in changes to the law, the changes will probably be specific to that contaminant rather than a major change in the structure of the statute. 5.5.4

Unresolved Issues

Two of the leading drivers behind the 1996 Amendments to the SDWA were not resolved: small system compliance and state primacy costs. Without some impetus to restructure small systems to improve economies of scale, their inability to finance compliance costs will persist. Monitoring relief, the State Revolving Loan Fund, grants for capacity development, small system variances, and other provisions of the 1996 Amendments simply provided a short-term bandage for what is a more pervasive structural and political problem. A further unresolved issue, and perhaps the most difficult to ultimately resolve, is the capacity of both USEPA and states to deal with the legislative and regulatory requirements of the Act. The demands put on USEPA and the states by all versions of the Act have been significant. USEPA’s levels of funding for the drinking water program have not been in line with the congressional demands placed on it. This is particularly true in the research and development (R&D) area but extends to all areas from regulatory development to enforcement. This is not peculiar to the drinking water program. Congress typically places more responsibility on federal departments and agencies than they are willing to fund since approved budgets reflect political and economic realities that may or may not be in line with mandated requirements. In the R&D area, this problem was foreseen in the 1996 Amendments. Expenditures on R&D are essential to the regulatory process outlined in the Act in order to develop the scientific and technical basis for decisions on standards. The Act

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requires USEPA to set aside $10 million per year from the SRLF to fund health effects studies, but because of political considerations, the funds have never been reserved or utilized. The overall underfunding of the science necessary to carry out the Act may drive future changes to the Act. Since 1974, states have been given primacy in implementing and enforcing regulations under the Act. The Act and its amendments have provided grants to states to carry out these requirements. Public water system supervision (PWSS) grants have proven far too small to effectively implement the requirements placed on states even when supplemented by state funds. States have been reluctant to significantly increase their investment in state drinking water programs given their other funding needs and the federal nature of drinking water mandates. The lack of federal commitment to unfunded federal mandates was another of the drivers of the 1996 Amendments, and although PWSS grants were increased, the total is far below what is required for an effective program. Recent regulations, such as the Lead and Copper Rule, those dealing with microbial and disinfection byproducts, and the Filter Backwash Rule require extensive interaction between water systems and states in the form of studies. This trend is expected to continue with the growing realization that a one-size-fits-all regulatory approach can lead to very cost ineffective regulations. However, such regulations will serve to increase demands on already stressed state programs.

5.5.5

Emerging Issues

Future challenges to the drinking water community that may lead to changes in the SDWA are many and varied, and to a large extent interrelated. On September 11, 2001 the terrorist attacks on the World Trade Center in New York and the Pentagon in Washington, DC, had a profound impact on the nation, its economy, sense of well-being and influence around the world. Federal, state, and local governments and the private sector reordered priorities to enhance security against potential future attacks. Banking, finance, and telecommunications moved rapidly to harden security against cyber attack. The water, energy and transportation sectors deployed additional personnel and resources to protect critical infrastructures from both physical and cyber attacks. Nationally, Congress provided $40 billion for defense and domestic security, including approximately $80 million for drinking water vulnerability assessments. Congress has enacted amendments to the SDWA requiring water systems to conduct vulnerability assessments and emergency response plans. Additional enforcement authority and increased funding for security-related research is also being considered. As the nation learns more about terrorism and the potential for physical and biological, chemical, and radiological contamination of water supplies, the SDWA may be amended even further. On the contaminant front, endocrine disrupting chemicals and pharmaceuticals in drinking water will receive increased attention. Both the SDWA Amendments of

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1996 and the Food Quality Protection Act of 1996 require a screening and testing program to determine if contaminants present in food and water may have endocrine-disrupting effects. The endocrine system regulates metabolism and a wide range of biological processes, such as control of blood sugar, growth and function of reproductive systems, so the occurrence of such contaminants in drinking water at levels of public health concern would cause major changes in drinking water treatment. The science on the issue is presently unclear, particularly at low contaminant dose levels. Pharmaceuticals have also been found at low levels in drinking water sources. A great deal of research is necessary before determining if these contaminants constitute a threat to treated drinking water. Population growth is leading to increased demands for water for both drinking and agricultural purposes. In some areas, these uses directly compete with efforts to restore water flow for ecological purposes or for protection of endangered species. Some sources of water will not be available for development or further development for drinking water purposes because of endangered species problems. Many groundwater aquifers are being drawn down for agricultural and drinking water purposes at rates far in excess of their natural recharge rates. While these problems are most visible in the arid Western states, they occur in all regions of the country. Increasing and conflicting usage demands on water sources will rise to the level where congressional action will be called for. While any congressional fix is likely to focus on other statutes, changes to the SDWA that encourage or require conservation measures are possible. Changes that address the increasing practice of wastewater recycle and reuse are also possible. Water infrastructure replacement challenges are already being felt and will increase in the future. Water distribution and wastewater collection systems have been constantly built and expanded over the past century. Such systems have a very long lifetime, but thousands on thousands of miles of the systems, particularly in the nation’s largest cities, are now reaching or have passed their useful life. The required investment is of such magnitude, in addition to the investments required by new regulations, that Congress has begun exploring the problem and a possible federal role in solutions through hearings. The infrastructure replacement challenge may spur changes to the SDWA’s SRLF provisions and funding levels. Environmental laws such as the SDWA were developed on a media by media (air, water, land) or contaminant (pesticides) basis. This structure has long been acknowledged to be inefficient for dealing with environmental problems that tend to occur across media. This arbitrary segmenting under the laws complicates or prohibits coordinated approaches to solving environmental problems. Although a watershed management approach to meet multiple environmental objectives has been recognized as the best approach, existing laws do not facilitate such an approach. There are strong forces at the federal level against integration of environmental laws since it would reduce the authority of the congressional committees overseeing each law as well as the turf of the various departments, agencies, and individual offices within those agencies that oversee regulations under each law. The 1996 Amendments to the SDWA required source water assessment programs and included a source water

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petition program to attempt to initiate at the state and local levels the very same coordination that the federal laws impede. The programs as presented in the law are not very effective, and the petition program in particular is likely to see little use. This area is one, however, that may see further work in future amendments. The trend in communications and information availability most evidenced by the dramatic growth of the Internet will continue. Advocacy groups as well as water suppliers will have enhanced opportunities to provide information to consumers. The so-called Consumer Right-to-Know provisions of the 1996 Amendments will likely be enhanced in future revisions to the law as communications technology advances. Already, there have been pilot projects involving water systems providing real-time or near-real-time water quality data to consumers via the Internet.

5.6

OUTLOOK FOR MAJOR CHANGE

Forces that have shaped SDWA legislation since the early 1970s indicate that any changes to the SDWA will occur incrementally. However, looking toward the future with an eye on the past doesn’t necessarily tell us where we’re headed in the long run. Major forces on the drinking water industry could bring about an abrupt transformation in legislation and regulation. Today, the industry is being forced to change in ways not previously considered. Globabilization, competition, security, and new demands for service and efficiency are moving utilities in new directions. As pressure on the resource itself grows from agriculture, population growth, and the environment, utilities will evolve in new and different ways. Corporate corruption, bankruptcies, and the economic downturn currently (2003) being experienced may affect the financial capacity of water systems to afford needed improvement. Out of necessity, drinking water utilities will be working with a larger regional or even national community to ensure that basic human and environmental needs are met, as Kader Asmai, former Minister for Water Affairs and Forestry in South Africa, put it, ensuring that there is ‘‘some for all, instead of more for some.’’ These trends could restructure the water industry and drive it to even higher levels of service, rendering irrelevant the contaminant-by-contaminant standard-setting process painstakingly detailed in the SDWA. Arguably, the SDWA has become what it is today because of the fragmented structure of the water industry in the United States. The law establishes various requirements based on system size and ability; it sets forth a standard-setting process targeted at large system capabilities, with provisions that are intended to provide latitude for smaller systems. Some will argue that it has failed, but Congress has attempted to develop a statute that creates programs that are implementable by a very fragmented and diverse industry. Restructuring of the water industry, along with new local pressures forcing industry changes to new technology, could result in the statute, as currently crafted, becoming obsolete.

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REFERENCES AMWA. 2000. Safe Drinking Water Act Primer. Washington, DC: Association of Metropolitan Water Agencies. Blodgett, J. 1994. Environmental Reauthorizations and Regulatory Reform: Recent Developments. Report for Congress (95-3 ENR). Washington, DC: Congressional Research Service. Congress. 1993. Our American Government. 102D Congress, 2d Session. H.Doc. 102-192. Washington, DC: U.S. Government Printing Office. Copeland, C. 1996. Reinventing the Environmental Protection Agency: EPA’s Water Programs. Report for Congress (96-283 ENR). Washington, DC: Congressional Research Service. Dove, R. 2001. Enactment of a Law. U.S. Senate. Washington, DC: Library of Congress. GPO. 2001. US Government Manual 2001=2002. Washington, DC: U.S. Government Printing Office. Heniff, B., Jr., 1999a. Overview of the Congressional Budget Process. Report for Congress (RS20368). Washington, DC: Congressional Research Service. Heniff, B., Jr., 1999b. Overview of the Authorization—Appropriation Process. Report for Congress (RS20371). Washington, DC: Congressional Research Service. Johnson, C. W. 2000. How Our Laws Are Made. U.S. House of Representatives. Washington, DC: Library of Congress. Lee, M. R. 1994. Environmental Protection and the Unfunded Mandates Debate. Report for Congress (94-739 ENR). Washington, DC: Congressional Research Service. Lewis, J. 1990. The spirit of the First Earth Day. EPA J. (Jan.=Feb.). Nelson, G. 1980. Earth Day ’70: What it meant. EPA J. (April). Rosenbaum, W. A. 1995. Environmental Politics and Policy. Washington, DC: Congressional Quarterly Press. Streeter, S. 1999. The Congressional Appropriations Process: An Introduction. Report for Congress (97-684 GOV). Washington, DC: Congressional Research Service. SDWA. 1974. Safe Drinking Water Act, 42 U.S.C., s=s 300f et seq. USDHEW. 1970. Community Water Supply Study: Analysis of National Survey Findings. Washington, DC: U.S. Department of Health, Education, and Welfare. USEPA. 1972. Industrial Pollution of the Lower Mississippi River in Louisiana. Dallas, TX: USEPA Region VI, Surveillance and Analysis Division. USEPA. 1973. EPA voices support for Safe Drinking Water Act. EPA press release, March 8. Washington, DC: U.S. Environmental Protection Agency. USEPA. 1975. Train stresses long-range planning as the environmental movement comes of age. EPA press release, April 22. Washington, DC: U.S. Environmental Protection Agency. USEPA. 1977a. EPA safe drinking water standards go into effect today. EPA press release, June 25. Washington, DC: U.S. Environmental Protection Agency. USEPA. 1977b. History Office, oral history interview, Douglas M. Costle, USEPA Administrator, Carter Administration. USEPA. 1986. President signs Safe Drinking Water Act Amendments. EPA press release, June 20. Washington, DC: U.S. Environmental Protection Agency. USEPA. 1990. Reducing Risk: Setting Priorities and Strategies for Environmental Protection. EPA Science Advisory Board. Washington, DC: U.S. Environmental Protection Agency.

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USEPA. 1992. EPA issues 23 final drinking water standards. EPA press release, May 19. Washington, DC: U.S. Environmental Protection Agency. USEPA. 1999. 25 Years of the Safe Drinking Water Act: History and Trends. EPA 816-99-007. Washington, DC: U.S. Environmental Protection Agency. USEPA. 2001. Annual Report FY 2000. EPA-190-R-01-001. Washington, DC: U.S. Environmental Protection Agency. Whitaker, J. C. 1988. Earth Day recollections: What it was like when the movement took off. U.S. Environ. Protect. Agency J. (July=Aug.).

PART II REGULATION DEVELOPMENT

Drinking Water Regulation and Health, Edited by Frederick W. Pontius. ISBN 0-471-41554-5 # 2003 John Wiley & Sons, Inc.

6 TOXICOLOGICAL BASIS FOR DRINKING WATER RISK ASSESSMENT JOYCE MORRISSEY DONOHUE, Ph.D. Office of Water, Office of Science and Technology, U.S. Environmental Protection Agency, Washington, DC

JENNIFER ORME-ZAVALETA Office of Research and Development, National Health and Environmental Effects Research Laboratory, U.S. Environmental Protection Agency, Corvallis, Oregon

6.1

INTRODUCTION

The U.S. Environmental Protection Agency (USEPA) is charged with protecting human health and the environment. Environmental protection decisions are often guided by risk assessments that are used to develop regulatory policy and other related guidance. Historically, in environmental protection, risk assessments were developed to protect humans from carcinogenic effects that could result from inhalation or ingestion exposures to specific chemicals. Risk assessments have since evolved to address endpoints other than cancer as well as stressors other than chemicals. Toxicological concepts used to develop risk assessments for drinking water contaminants are discussed in this chapter. Disclaimer : This chapter has been reviewed within the USEPA and represents the views of the authors; it does not necessarily reflect Agency policy. Any mention of trade names or products does not constitute endorsement. Drinking Water Regulation and Health, Edited by Frederick W. Pontius. ISBN 0-471-41554-5 # 2003 John Wiley & Sons, Inc.

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Figure 6.1

NAS risk assessment paradigm.

In 1983, the National Academy of Sciences (NRC 1983) formalized the process of human health risk assessment into four organizing steps: hazard identification, dose–response assessment, exposure assessment, and risk characterization (Fig. 6.1). Hazard identification, later renamed hazard characterization (NRC 1994), is a qualitative evaluation of whether exposure to a substance such as a drinking water contaminant would produce an adverse or otherwise undesirable effect. The data used to make such a determination usually come from animal studies. In a few instances, human epidemiologic, occupational, clinical, or case studies may be available for the contaminant of interest. Having causally linked exposure with an effect, the next step, dose–response assessment, involves a more quantitative evaluation of the empirical evidence relating a specific exposure dose to the effect of interest. In particular, the available data are examined to determine the relationship between the magnitude of the exposure and the probability of the observed effect. The exposure assessment step involves an evaluation of human exposure information. This includes a comparison of exposure before and after regulatory controls, as well as a characterization of the environmental fate and transport of the contaminant from the source to the exposed population by different media (e.g., air, water, food) and different exposure routes (e.g., ingestion, inhalation, dermal contact). All of this information is captured in a summary statement, or risk characterization. The risk characterization contains a description of the overall nature and magnitude of risk posed to human populations exposed to a particular contaminant. Included in the description is a discussion of what is known and not known about the hazards posed by the substance, what models were used to quantify the risk and why they were selected, assumptions and uncertainties associated with the qualitative and quantitative aspects of the assessment, and general level of confidence in the assessment.

6.2 TOXICOLOGICAL EVALUATION OF DRINKING WATER CONTAMINANTS Risk assessments for drinking water contaminants involve a toxicological evaluation of the contaminant. Toxicology, by definition, is the study of poisons and their effect on living organisms. It encompasses many scientific disciplines, including chemistry, biochemistry, epidemiology, physiology, pathology, statistics, modeling, and

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ecology. Environmental toxicology is that branch that studies the biological effects of environmental chemicals. Environmental exposure to chemicals can occur through the air, food or water, or dermal contact. Upon entering the body through one of these routes, a chemical can interact with various biological systems to produce an effect. The type of interaction and resulting effect depend on the chemical itself and the dose. Basically, everything has the potential to be toxic once a certain dose has been reached. Some chemicals may produce an effect once a certain dose or concentration of the chemical has reached a particular site in the body. Doses below this level will not result in the effect. This type of effect is commonly referred to as a threshold effect. In some cases, an effect could theoretically result after exposure to just one molecule of a chemical. These effects are commonly referred to as nonthreshold effects, and are often assumed as the mechanism by which some chemicals cause cancer. Effects can also be categorized as reversible or irreversible. Reversible effects disappear when an organism is no longer exposed to the chemical. Effects that involve a permanent change in the structure or function of a biological system or persists after the exposure ends are considered irreversible. Chemical contaminants entering an organism may cause an effect either directly or indirectly, after the chemical has been modified by the organism. Organisms are able to biologically transform chemicals to different forms usually with enzymes. As a result, a particular chemical contaminant can undergo a number of chemical changes, forming metabolites that are chemically distinct from the original chemical contaminant (Sipes and Gandolfi 1986). In some cases, it is the modified chemical rather than the parent compound that produces a toxic effect within the organism. The following are some of the biological effects that can result from chemical exposure:
Lethality—the ability of a chemical to cause death
Liver, kidney, or other organ effects—effects that alter the structure or function of the organ
Biochemical effects—changes in the activity or concentration of biomolecules that are indicative of tissue damage and=or impaired cellular function
Carcinogenicity—the ability of the chemical to cause cancer
Mutagenicity—the ability of the chemical to cause changes in genetic material
Reproductive effects—effects on the ability of an organism to reproduce
Developmental effects—effects on the developing organism
Neurological effects—effects on the structure and function of the nervous system

These effects are often the endpoints of concern observed in epidemiologic or other human studies and evaluated in laboratory or other types of experimental research.

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In addition to dose, toxicologic effects may be dependent on the duration of chemical exposure. Therefore, studies evaluate the potential occurrence of these effects following certain types of exposure, including single, intermittent, or continuous exposure over a certain proportion of an organism’s lifetime. The following lists common experimental study durations: Acute toxicity—effects observed after one or a few exposures Subchronic toxicity—effects observed after repeated exposure for a portion of the animal’s or human’s lifetime (for rodents, this is approximately one-tenth of the lifetime or 90 days) Chronic toxicity—effects observed after repeated exposures for most of an animal or human’s lifetime As noted above, toxicology data can come from human or animal studies and are discussed separately. 6.2.1

Human Studies

In risk assessments to protect human health, human data are preferred over animal data. Human studies include epidemiologic, clinical, occupational, or case studies. Epidemiology is simply defined as the study of epidemics, and in particular, the causes that explain patterns of disease frequency in humans (Rothman and Greenland 1998). There are two broad types of epidemiologic studies: descriptive and analytic. Descriptive studies include correlational or ecologic studies (those that compare geographic regions), cross-sectional studies, and case reports. The descriptive studies collect information on groups of people and help to generate hypotheses associating chemical exposure with an effect. (Epidemiology is discussed further in Chapter 7.) Analytic studies are designed to test specific hypotheses related to chemical exposure causing a particular disease or effect. One type of analytic study is called an intervention study. Like clinical studies, intervention studies are generally used to test therapeutic agents. Another type of analytic study more commonly used to study environmental toxicants is the observational study. Observational studies are categorized into two types: case–control or cohort. Case–control studies involve a comparison of persons with the condition of interest (e.g., high blood pressure) compared with a reference or control group who do not have the condition. Cohort studies follow groups of individuals who have been exposed or not exposed to the factor(s) of interest over time. Incidence rates for the condition of interest are compared between groups with different exposure levels. Although epidemiology studies provide information on the potential effects of chemical exposure in human populations, uncertainties can affect the interpretation of study results. In these studies, several factors that could affect the study findings, such as age, gender, or other types of exposure (e.g., occupational exposure, cigarette smoke), occur in addition to the exposure of interest. All of these potential

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confounders could make it difficult to attribute an effect or disease to any one chemical exposure. 6.2.2

Animal Studies

Experimental animal studies are the primary means for evaluating the toxicity of a chemical. Toxicity studies using laboratory animals provide a direct method for testing a cause-and-effect relationship between exposure and effect. The animals used most often are mice and rats, because a number of genetically homogeneous strains are available and it is possible to test a sufficiently large number of animals to observe statistically as well as biologically significant effects. In some circumstances, other experimental animals such as monkeys, guinea pigs, hamsters, rabbits, and dogs are used. Selection of a particular animal species depends on the type of toxicity test to be conducted and how well the selected species would predict a human response. It is generally assumed that if an animal metabolizes a chemical in much the same way as do humans, it is a good surrogate for predicting human toxicity. In general, monkeys and dogs are more similar to humans than rodents, but are more difficult to study because, for example, there is potentially a greater expense for maintenance and resulting limitations on the numbers of animals that can be accommodated in each dose group. In controlled experiments, animals are exposed to several different doses of a chemical to see which dose produces an effect and the type of effect that results. Toxicity studies often utilize high-dose exposures to increase the likelihood of detecting any adverse effect that could result from exposure to the chemical. Short-term range-finding studies are generally conducted in small groups of animals in order to identify likely effects and select the doses for longer-term test protocols. Ideally, the lowest dose tested will not produce an effect, while the intermediate dose would result in mild observable effects, and the highest dose producing more pronounced toxic effects. Use of animal studies in estimating human risk has been criticized for many reasons, including the introduction of additional uncertainties. Examples include the extrapolation of effects in genetically homogeneous laboratory strains to the genetically heterogeneous human population and extrapolation of high experimental doses to predict human risk at lower environmental concentrations. These uncertainties are taken into account in quantifying risk (see text below).

6.3

USE OF TOXICITY INFORMATION IN RISK ASSESSMENT

When a risk assessment is conducted, all available toxicity data are gathered from the published literature or other sources, such as data submitted to regulators as confidential business information. Data that describe cancer effects or those that are relevant to the induction of cancer are assessed separately from noncancer effects. For cancer effects, data are assessed qualitatively (with respect to hazard identification) and quantitatively (in terms of dose–response assessment). The qualitative

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evaluation involves an assessment of the weight of evidence for the chemical’s potential to cause cancer in humans and accounts for the mode of action by which the chemical produces cancer in the body (USEPA 1996, 1999). The data considered in the risk assessment include both human and animal studies (if available). The method for quantifying the potential carcinogenic risk depends on the mode of action, that is, whether the chemical is thought to produce cancer through a mutagenic mechanism, or is secondary to cellular toxicity. In cases where the mode of action is unclear, both approaches may be used to quantify risk. Risk may be assessed for different routes of exposure such as inhalation, oral, or dermal.

6.3.1

Cancer Risk Guidelines

The 1986 USEPA Guidelines for Carcinogen Risk Assessment (USEPA 1986) established five alphanumeric cancer categories (Table 6.1). Although these classifications will be phased out in the future by the Agency’s 1996=1999 guidelines, they are now still widely used. USEPA proposed revisions to the 1986 guidelines in the proposed 1996=1999 Guidelines for Carcinogen Risk Assessment (USEPA 1996, 1999). These revisions include replacing the alphanumeric system with descriptors and a narrative describing a chemical’s potential to produce cancer in humans. Under the new proposed guidelines, there are five descriptors as follows:
Known human carcinogen
Likely to be carcinogenic to humans
Suggestive evidence of carcinogenicity, but not sufficient to assess human carcinogenic potential
Data inadequate for an assessment of human carcinogenic potential
Not likely to be carcinogenic to humans

TABLE 6.1 Group A B

C D E

USEPA Cancer Classification Categories Category Human carcinogen based on epidemiologic or other human data Probable human carcinogen: B1 indicates limited human evidence with sufficient evidence in animals B2 indicates sufficient evidence in animals and inadequate or no evidence in humans Possible human carcinogen based on limited or suggestive evidence in animals Not classifiable as to human carcinogenicity Evidence of noncarcinogenicity for humans

6.3 USE OF TOXICITY INFORMATION IN RISK ASSESSMENT

6.3.2

139

Effects Other than Cancer

For effects other than cancer, USEPA develops either an oral reference dose (RfD) or an inhalation reference concentration (RfC). For drinking water contaminants, the oral RfD is determined. The RfD is defined as an estimate of a daily exposure that is not expected to produce adverse effects over a person’s lifetime. To develop an RfD, one must evaluate the available data from human or animal studies. For drinking water contaminants, oral drinking water studies are preferred, but studies using other routes such as food or inhalation may be considered. For each of these studies, the highest dose that causes no adverse effect, the no-observed-adverse-effect level (NOAEL), and the lowest dose that produces an adverse effect, the lowestobserved-adverse-effect level (LOAEL) are identified for each appropriate (i.e., relevant to humans) test species. The RfD has generally been estimated by dividing a NOAEL or LOAEL by an uncertainty factor (Fig. 6.2). The NOAEL (or LOAEL in the absence of a NOAEL) is selected on the basis of the relevance of the test species to humans, the sensitivity of the response relative to those identified from other studies, and whether the NOAEL is supported by other data. The NOAEL is divided by an uncertainty factor that accounts for the differences in response to toxicity within the human population as well as differences between humans and animals, if animal data are used. If the study selected as the basis for the RfD involves an exposure that is less than the animals’ lifetime, another factor may be applied. Similarly, if a LOAEL is used in estimating the RfD, a factor may be applied to account for the absence of a NOAEL. Professional judgment may suggest the use of an extra uncertainty factor

Figure 6.2 Example of RfD determination for noncarcinogenic effects. The uncertainty factor (UF) will differ depending on whether the point of departure (PoD) for the RfD calculation in a NOAEL, LOAEL, or BMDL (x is the selected response level: 10%, 5%, etc.).

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because of an insufficient database for that chemical, or there may be special properties of the chemical that would require an adjustment of the uncertainty factor. In selecting the uncertainty factor, one must evaluate each area of uncertainty and assign a value of 1, 3, or 10 depending on the strength of the data. A threefold factor is used when data reduce the need to apply a 10-fold unit of uncertainty. For example, a LOAEL that is an early biomarker of toxicity or a nearly complete toxicity data set may require a threefold uncertainty factor rather than a 10. An uncertainty factor of 1 is employed when the data are clearly from the most sensitive members of the population, eliminating the need for an intraspecies adjustment, or when there are data to demonstrate that the responses of the animals are the same as those of humans, eliminating the need for an interspecies adjustment. The net uncertainty factor is the product of the individual factors applied. Uncertainty factors tend to range from 1 to 3000-fold (Table 6.2). Uncertainty factors greater than 3000 may indicate too much uncertainty to have any confidence in the risk assessment. The RfD may also be determined using a benchmark method instead of the traditional NOAEL=uncertainty factor approach. The benchmark dose (BMD) is defined as the lower statistical limit for the dose corresponding to a specified increase in the level of the critical health effect over the background level (Crump 1984). In other words, the BMD approach does not utilize a single dose such as a NOAEL for estimating risk, but considers the available data from which a dose level corresponding to an increase in the incidence of an adverse health effect is identified. Statistical modeling of the dose–response curve is used to determine the dose that corresponds to a specific population response level. Frequently, a 10% response above the population background is the response level identified, although other response levels from the low end of the dose–response curve can also be selected when supported by the data. The lower confidence bound on this dose, referred to as the effective dose or LED10, is then divided by an uncertainty factor to estimate the RfD. The uncertainty associated with this method for estimating risk is generally less than the NOAEL=uncertainty factor approach. However, the data requirements for using this approach are more rigorous. The general risk assessment conducted for both cancer- and non-cancer-related endpoints provides the foundation for developing drinking water-specific risk assessments. These risk assessments are used to establish the health-based guidelines and standards discussed below.

TABLE 6.2 Uncertainty Factors Factor 1, 3, or 1, 3, or 1, 3, or 3 or 10 1, 3, or

Area of Uncertainty Addressed 10 10 10 10

Differences within the human populations Differences between humans and animals Use of less than lifetime data for estimating lifetime risk Use of a LOAEL in the absence of a NOAEL Data gaps or other chemical-specific uncertainty

6.3 USE OF TOXICITY INFORMATION IN RISK ASSESSMENT

6.3.3

141

Maximum Contaminant Level Goal (MCLG)

The RfD, cancer classification, and method for estimating carcinogenic risk (e.g., slope factor for nonthreshold chemicals or point of departure for threshold-like chemicals) are the critical elements in establishing the MCLG for a drinking water contaminant. The MCLG is defined as a concentration of a contaminant in drinking water that is anticipated to be without adverse effects over a lifetime. The methodology used in establishing an MCLG will differ depending on the nature of the critical adverse effect. For the purpose of establishing the MCLG, contaminants fall into one of five categories:
Linear (genotoxic) carcinogens
Carcinogens with an accepted nonlinear mode of action
Carcinogens for which a mode of action has not been established and that are thus treated using a linear approach
Contaminants with a threshold, non-cancer-critical effect
Chemicals with a threshold, non-cancer-critical effect that may have some tumorigenic activity This arbitrary view of the world of chemical contaminants is presently in a state of flux, a factor that somewhat complicates understanding the basis of an MCLG. The unsettled status of the procedures used in development of an MCLG is a product of the fact that the 1996=1999 drafts of the USEPA new cancer guidelines have not been finalized. In addition, there is activity under way to harmonize the approaches used in the risk assessment for carcinogens and noncarcinogens. Completion of these two activities is likely to reduce the number of categories above from five to three by removing the distinction between carcinogens and noncarcinogens and focusing the risk assessment on whether a chemical acts through a linear, nonlinear, or unidentified mode of action. Under present USEPA policies, the MCLG for a linear carcinogen or a carcinogen with an unidentified mode of action is zero. For example, the MCLG for bromoform in the 1998 disinfectant and disinfectant byproduct rule was established at zero because all evidence pointed to the fact that it caused the development of tumors through mutations to DNA, a linear mode of action. The MCLG for arsenic is zero because, although there is some evidence to suggest that it may be tumorigenic through a nonlinear mode of action, there are not enough data to identify either the mode of action or the shape of the dose–response curve at doses below those associated with effects that can be detected with statistical confidence. Cancer risks associated with exposure to such chemicals are estimated by extrapolation using a multistage dose–response model (Fig. 6.3). Chloroform, on the other hand, has been a different story. In 1998, the Agency established an MCLG of zero for chloroform in order to be protective, although there was strong evidence to demonstrate that it was tumorigenic through a nonlinear mode of action. In other words, chroroform does not appear to cause cancer through a mutagenic mode of action (i.e., because it causes change in the structure of DNA). Instead, data indicate that the tumorigenic properties of chloroform are a conse-

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TOXICOLOGICAL BASIS FOR DRINKING WATER RISK ASSESSMENT

Figure 6.3

Example of cancer risk extrapolation using the linear dose–response model.

quence of its ability to cause cell death, thereby stimulating rapid cell division and tissue repair. It is theorized that rapid cell division leads to a series of DNA replication errors that eventually culminate in tumor development. In 2000, the Court of the District of Columbia decreed that USEPA remove the zero MCLG for chloroform and establish a value based on its nonlinear mode of action. A nonzero MCLG will be proposed by the Agency as part of the Stage II rule for disinfection byproducts. The risk assessment supporting the nonzero MCLG was accepted by the Agency and posted on the Agency Integrated Risk Information System (IRIS) in October 2001 (USEPA 2001). For noncarcinogens, the MCLG has traditionally been derived from the RfD under the assumption that there is a threshold below which there are no effects of exposure. As described above, the RfD is developed from the dose–response data for the critical effect(s) observed in a well-designed toxicologic or epidemiologic study, or from a collection of human data that clearly demonstrate a NOAEL following exposure. The following equation is applied in calculating the MCLG from the RfD:  MCLG ¼ where

 RfD  (body weight)  relative source contribution (RSC) drinking water intake RfD body weight drinking water intake RSC

¼ reference dose ¼ 70 kgðadultsÞ ¼ 2 L=day ¼ the portion of the total exposure contributed by water. The default value is 20%:

6.4 HEALTH ADVISORIES

143

For drinking water regulations, chemicals have been grouped in three categories (Category I, II, or III). Category I chemicals are those that were categorized as Groups A or B under the 1986 cancer guidelines, and thus, have a zero MCLG. Chemicals characterized as Group C, possible carcinogens under the 1986 cancer guidelines, were placed in Category II. Rather than treat these compounds as carcinogens in determining the MCLG, USEPA traditionally added a risk management factor of 10 to the denominator of the MCLG equation above, thereby lowering the projected no-effect concentration in drinking water to a tenth of that suggested by the RfD. Category III chemicals are those with no evidence of carcinogenicity via the oral route (Groups D and E) and have an MCLG based on the RfD following the equation above. In the future, MCLG values for chemicals found to have tumorigenic effects as a result of a nonlinear mode of action will be determined using the threshold approach outlined above. However, in place of the RfD, the point of departure (PoD) from the dose–response curve for either tumors or a precursor preneoplastic event will provide the basis for the MCLG. The PoD will be divided by a margin of exposure (MoE), which is similar to the uncertainty factor in the RfD equation, and will replace the RfD term in the equation above. At present, it is difficult to predict whether the risk management factor of 10 will continue to be applied for chemicals lacking clear-cut evidence on carcinogenicity. Exposures to most chemicals occur from other media in addition to water. Many of the contaminants in water are also found in foods. Others, particularly volatile compounds, are present in ambient air. The relative source contribution (RSC) adjusts the MCLG so that only a portion of the total allowable exposure is allocated to drinking water. The RSC can be applied using either a percentage approach or a subtraction approach. The percentage approach was used for all current MCLG values. The RSC is preferably based on data regarding the exposures that occur from food, air, and other important media such as personal care products or pharmaceutical agents. However, the required data are often limited leading to the use of default RSC values. In the Ambient Water Quality Criteria Methodology Document for Human Health, a decision-tree approach for evaluating data adequacy and determining the appropriate default when key data elements are lacking is described. The approach described in the Ambient Water Quality Criteria Methodology is being applied in the derivation of MCLG values for upcoming regulations. When the lack of key data elements prevents using a data-derived percentage or subtraction allocation, default adjustments of 20%, 50%, or 80% are possible when supported by the appropriate data. In the absence of appropriate data, the 20% default is applied.

6.4

HEALTH ADVISORIES

Many chemicals that can contaminate drinking water have not been regulated by USEPA. In some cases, contamination is the result of an accidental spill or a

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temporary problem. The USEPA Health Advisory (HA) program was developed to assist local officials and utilities when dealing with episodic drinking water contamination problems and=or contamination with unregulated contaminants. HA values describe nonregulatory concentrations of drinking water contaminants at which adverse health effects would not be anticipated to occur over specific exposure durations. They serve as informal technical guidance to federal, state, and local officials responsible for protecting public health when emergency spills or contamination situations occur. They are not legally enforceable federal standards and are subject to change as new information becomes available (USEPA 1989). Currently available (2002) HA values are provided in Appendix A. HA values are developed for 1-day, 10-day, longer-term (approximately 7 years, or 10% of an individual’s lifetime), and lifetime exposures on the basis of data describing noncarcinogenic endpoints of toxicity. For those substances that are known or probable human carcinogens, according to the Agency’s 1986 classification scheme for carcinogens (Group A or B), lifetime HAs are not recommended (USEPA 1989). For Group A or B carcinogens, the carcinogenic risk estimates for drinking water are presented in the HA documents. The 1-day and 10-day values are established for a 10-kg (22-lb) child based on the premise that this group is the most sensitive to acute toxicants. Longer-term exposures, estimated to be 7 years or one-tenth of an average lifetime, are calculated for both the 10-kg child and adults. Each of these HA calculations assumes that drinking water is the only source of exposure to the chemical. The lifetime HA is established only for the adult and, as indicated by its name, assumes that exposure occurs over the entire lifetime. The lifetime HA is calculated using the same approaches applied in deriving the MCLG for chemicals with a threshold toxic effect. As is the case with the MCLG, the lifetime HA is adjusted for other sources of exposure to the contaminant by applying an RSC factor. The lifetime HA is the most conservative of the suite of HA values and is the equivalent of the MCLG for unregulated contaminants. A lifetime HA is generally not established for a contaminant that is a known or probable carcinogen (Categories A and B of the 1986 USEPA cancer guidelines). Lifetime HA values for a Group C carcinogen include a 10% reduction in the calculated lifetime value as a risk management adjustment to protect against possible human carcinogenicity. Treatment of acute exposures is one unique feature of the HA program. The acute HAs were developed specifically for dealing with episodic drinking water contamination incidents resulting from spills, accidental releases, or equipment malfunction that lead to contamination of drinking water. Because many of these contamination incidents persist for only a short period of time, it is important to provide guidelines that apply to acute exposures. A 1-day HA is an estimate of the concentration of a chemical in drinking water that is not expected to cause any adverse noncarcinogenic effects for up to 1 day of exposure. The 10-day HA value is the concentration of a chemical in drinking water that is not expected to cause any adverse noncarcinogenic effects for up to 10 days of exposure. Both are established for a 10-kg child consuming 1 L of water per day,

6.5 FUTURE OUTLOOK

145

because the child is expected to be the most sensitive to acute exposures (USEPA 1989). The approximate body weight of a 1-year-old child is 10 kg. Ideally, the less-than-lifetime HAs are developed from a study in humans or animals that provides dose–response data for the critical effect using the desired duration (i.e., 1 day, 10 days, 90 days) (USEPA 1989). Examination of all the data from the appropriate short-term studies provides information on the critical effect. It is important that a complete data set be available for identifying the spectrum of health effects resulting from short-term exposures and their dose–response characteristics. The dose–response data are used to identify a NOAEL, LOAEL, or benchmark dose (LED10 or lower as justified by the data) for the critical effect associated with the duration of interest. The LOAEL is used for calculation only if a NOAEL has not been identified and if the observed effect is an early marker of toxicity rather than a frank (severe) effect. The HA value is derived using the following equation: 

ðNOAEL or LOAELÞ  10 kg Less-than-lifetime HA ¼ UF  ð1 L=dayÞ



where UF is the uncertainty factor. In the derivation of the less-than-lifetime HAs, uncertainty factors are most often employed for the intraspecies adjustment, interspecies adjustment, and use of a LOAEL in place of a NOAEL. The uncertainty factors are usually in multiples of 10. An uncertainty factor to adjust for study duration deficiencies is not applied. Instead the HA value for the next-higher duration is used in lieu of the shorter duration (i.e., a 10-day value in place of the 1-day value). The longer-term HA is calculated for both a child and an adult. The less than lifetime HA values do not include an RSC adjustment.

6.5

FUTURE OUTLOOK

Risk assessment approaches and their application to regulatory toxicology are consistently changing as advances in science reduce the uncertainties in extrapolating data from studies in animals or limited observations in humans to the entire regulated population. Improvements in the design of both animal and epidemiologic studies have reduced the impact of confounding variables on results and improved the reliability of the data. Increased understanding of the biological changes responsible for cancer and noncancer adverse effects improves the ability of a risk assessor to postulate a mode of action for a toxic event and model dose– response curves below the ability of a study to measure change. As research allows hypothesis to become theory and improves the precision of NOAEL, LOAEL, and benchmark dose estimates, the risk assessment methodologies applied in establishing MGLG and Health Advisory values will change as well. The major impact of improvement is likely to be in the application of data-derived uncertainty factors and the narrowing of the uncertainty component reflected in the MCLG or HA value.

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Regulations and guidelines that apply to drinking water and air are important. Humans and animals require a daily intake of water to live. Unlike contaminants that affect specific foods or commercial products where avoidance is one measure that can be used to modulate the risk to sensitive populations, this option is limited when it comes to drinking water. The drinking water MCLG and HA values must err on the side of protection. Accordingly, changes in risk assessment approaches will be introduced only when supported by a strong body of scientific data.

ACKNOWLEDGMENTS The authors would like to thank Julie Du, Hend Galal-Gorchev, and Edward Ohanian for their thoughtful comments and insights in reviewing this document.

REFERENCES Crump, K. S. 1984. A new method for determining allowable daily intakes. Fund. Appl. Toxicol. 4:854–871. NRC. 1983. Risk Assessment in the Federal Government: Managing the Process. Washington, DC: National Academy Press. NRC. 1994. Science and Judgment in Risk Assessment. Washington, DC: National Academy Press. Rothman, K. J. and S. Greenland. 1998. Modern Epidemiology, 2nd ed. Baltimore: Lippincott Williams & Wilkins. Sipes, I. G. and A. J. Gandolfi. 1986. Biotransformation of toxicants. In Casarett and Doull’s Toxicology. The Basic Science of Poisons, 3rd ed. C. D. Klaassen, M. O. Amdur, and J. Doull, eds. New York: Macmillan. USEPA. 1986. Guidelines for Carcinogenic Risk Assessment. Fed. Reg. 51:33992–34003. USEPA. 1989. Guidelines for Authors of EPA Office of Water Health Advisories for Drinking Water Contaminants. Washington, DC: Office of Drinking Water, Office of Water. USEPA. 1996. Proposed Guidelines for Carcinogen Risk Assessment. EPA=600=P-92=003C. Washington, DC: Office of Research and Development. USEPA. 1999. Guidelines for Carcinogen Risk Assessment. Review Draft. Washington, DC: USEPA, Risk Assessment Forum. USEPA. 2000. Methodology for Deriving Ambient Water Quality Criteria for the Protection of Human Health. Technical Support Document. Vol. 1, Risk Assessment. EPA-822-B-00-005. Washington, DC: Office of Science and Technology, Office of Water. USEPA. 2001. Toxicological Review of Chloroform. Washington, DC: Office of Research and Development.

7 EPIDEMIOLOGIC CONCEPTS FOR INTERPRETING FINDINGS IN STUDIES OF DRINKING WATER EXPOSURES GUNTHER F. CRAUN, P.E., M.P.H., D.E.E. Gunther F. Craun and Associates Staunton, Virginia

REBECCA L. CALDERON, Ph.D. National Health and Environmental Effects Laboratory, U.S. Environmental Protection Agency Research Triangle Park, North Carolina

FLOYD J. FROST, Ph.D. The Lovelace Institutes, Albuquerque, New Mexico

7.1

INTRODUCTION

To the inexperienced, environmental epidemiology may appear to be an uncomplicated, straightforward approach to studying exposure–disease associations in human populations. Epidemiologic studies can provide useful information about the risks of environmental exposures that human populations may actually experience, but the study designs and their conduct are not as simple as supposed. Many of the issues are complex and subtle, and this needs to be realized so that the studies can be Disclaimer : The views expressed in this chapter are those of the individual authors and do not necessarily reflect the views and policies of the USEPA. The chapter has been subject to the Agency’s peer and administrative review and approved for publication. Drinking Water Regulation and Health, Edited by Frederick W. Pontius. ISBN 0-471-41554-5 # 2003 John Wiley & Sons, Inc.

147

148

EPIDEMIOLOGIC CONCEPTS

properly designed and findings will be meaningful. Because the studies appear to be so straightforward, they are sometimes conducted by investigators with little training and experience, often leading to results that are difficult to interpret. Also, scientists with little knowledge of epidemiology feel comfortable explaining the importance of findings to the public, and this can lead to conflicting interpretations of the findings. A hypothetical example can help explain. A government agency releases statistics that show high cancer mortality in certain counties in the United States. A chemist wonders whether increased cancer mortality is related to environmental exposures. The chemist has compiled a computer file of chemical analyses reported by public water utilities. She decides to conduct a study because in some of the counties with high mortality rates water utilities have occasionally recorded high levels of some chemical constituents. The chemist uses a widely available software program for a statistical analysis of possible associations between reported levels of chemicals in water and cancer rates. She finds no correlation between any of the specific water quality parameters and cancer mortality; however, a statistically significant correlation is observed between cancer mortality and chlorinated surface water. The chemist concludes that chlorination byproducts, which were not included in the database, are responsible for increased cancer mortality and prepares a paper for publication. The article is peer-reviewed by an epidemiologist, who points out that a large elderly population has migrated to many of the counties in the past 10 years and in some counties the workforce is employed primarily in the chemical industry. Both of these factors could be responsible for much, if not all, of the increased cancer mortality in these counties. In addition, the reviewer notes that site-specific cancer rates should be evaluated rather than all cancers and that, among other factors, cancer incidence and survival should be considered in the analysis. Being an experienced environmental epidemiologist, the reviewer also notices that most of the population in several counties with high mortality rates uses individual wells, not public water systems. The chemical analyses in the database applied only to public water systems. The article is rejected for publication. The author is informed of these potential problems, and recommendations are made to help the author improve the analysis. Before reaching any conclusions about the observed association, additional efforts must be undertaken to evaluate potential sources of bias and confounding and improve the assessment of exposure. The chemist, on reading these comments, becomes confused and angry that her finding is not given a high priority for publication and decides the finding is so important that the public must be made aware of her research. The study is reported on page 1 of the local newspaper, and the chemist explains the findings in a 30-second news bite on television. Also interviewed is another scientist who describes the study’s flaws and says that the findings are uninformative. Now, the public is confused, and a local politician wants to know who hired the scientist to dispute such an important finding. A study that seemed so straightforward has now become the center of controversy. Whom is the public to believe? What risks are posed by chlorinating drinking water? There are many questions but few answers. Recently, results of environmental studies have increasingly provoked controversy about the need for regulatory actions. The public is often confronted by conflicting results and conflicting interpretations of these results, as water system

7.2 WHAT IS EPIDEMIOLOGY?

149

managers, engineers, and scientists debate the contradictory results. Unlike toxicologists, who can conduct replicate experiments with genetically identical strains of animals randomly assigned to various exposure groups, epidemiologists must rely on observations in human populations. Except in clinical trials, the perfect experimental situation is seldom found in human populations. People are never randomly distributed in a particular geographic location or neighborhood, nor is each person in a study likely to have similar lifestyles, diets, or other behaviors. Neither are exposures likely to be randomly distributed among persons who have similar behavioral or demographic characteristics. Since epidemiologists deal with the complexities of real-life, human experiences, they are usually conservative in their interpretation and cautious about their study conclusions. Comments made by Wade Hampton Frost in 1936 (Snow 1965) continue to apply: Epidemiology at any given time is something more than the total of its established facts . . . it is not easy, when divergent theories are presented, to distinguish immediately between those which are sound and those which are merely plausible.

Since epidemiologists are increasingly studying water contaminants, it is important for drinking water professionals to become more familiar with methods. The information in this chapter should help readers understand frequently used terminology, why certain types of studies are conducted, sources of possible bias, some of the reasons why results can be controversial, and the complexity of interpreting exposure–disease associations. Readers should also gain an appreciation of the complexity and importance of epidemiology in assessing health risks.

7.2

WHAT IS EPIDEMIOLOGY?

The term epidemiology, derived from the Greek roots epi (on), demos (people), and logos (study), is the study of the distribution and determinants of disease and injuries in human populations and the application of this knowledge to the prevention and control of health problems (Last 1995; Rockett 1994). Whereas clinicians consider the unique problems of diagnosing, treating, and preventing disease in individual patients, epidemiologists view disease primarily at the population level, describing its occurrence and statistically associating exposures, demographic characteristics, or behaviors with the disease in order to develop public health control measures. Besides describing temporal trends, geographic clustering, and other patterns of disease occurrence, epidemiologists seek explanations for disease etiologies, obtain information about characteristics and behaviors that may increase, or reduce, the risk of disease, and evaluate public health conditions or therapeutic interventions.

7.3

HISTORICAL ORIGINS

The origins of epidemiology date back over 2000 years to a manuscript (On Airs, Waters, and Places attributed to Hippocrates) describing the influence of environ-

150

EPIDEMIOLOGIC CONCEPTS

mental factors on the occurrence of disease (Rockett 1994). However, it was not until the seventeenth century with John Graunt’s observations about births and deaths in England that a firm foundation was laid for epidemiology. In the mid nineteenth century John Snow, William Farr, and Ignaz Semmelweis moved beyond describing disease trends and patterns and began to offer possible explanations for their observations (Snow 1965, Rockett 1994). Snow’s investigation of the occurrence and location of cholera deaths in the Golden Square district convinced the Board of Guardians to order the pump handle removed from the Broad Street well (Snow 1965). His hypothesis that sewage contaminated drinking water was responsible for cholera was strengthened by evidence that cholera mortality was higher in London households served by the Southwark and Vauxhall Water Company than in households served by the Lambeth Company. The Lambeth Company obtained water from the River Thames at a location free of London’s sewage; the Southwark and Vauxhall Company obtained water contaminated by sewage. Snow was able to compute mortality rates for his comparison because he could identify both the fatalities and their household water supplier. Information about mortality was available largely because of Farr’s efforts to systematically collect information about deaths. In Hungary, Semmelweis tested his hypothesis that medical students transmitted childbirth fever, by requiring medical personnel in his wards to wash their hands and soak them in chlorinated lime before conducting pelvic exams. Within 7 months, lower mortality rates were found in these birthing wards than in wards where the intervention was not implemented, thus offering a control measure to prevent disease long before its etiologic agent was identified. Although these two examples are almost 150 years old, they serve as dramatic reminders of the powerful and unique role epidemiology can play in the identification of health risks and prevention of disease, even though the specific etiologic agent may not be known. More recently, epidemiologists warned of lung cancer and other health risks in cigarette smokers many years before analytical chemists and toxicologists were able to identify the specific chemicals in tobacco smoke that may be carcinogens (Doll and Hill 1964).

7.4

DISEASE MODELS

Epidemiologists use disease models to help evaluate and explain disease etiologies. The simplest of these models is the triad (Fig. 7.1). The host, agent, and environment coexist independently, and disease occurs only when there is interaction between them (Rockett 1994). Many diseases have multiple agents, exposures, or risk factors that cause the disease or influence the course of the disease, and these must all be considered. Thus, a slightly more complex disease model must now be presented for cholera, which although it is often caused by contaminated water, can also be transmitted in other ways (Fig. 7.2). The etiologic agent and all relevant social, physical, or biological environments (e.g., personal behaviors, cultural practices, hygiene and sanitation practices, climate, and reservoirs of infection) combine to ‘‘cause’’ disease if the host is susceptible. Host susceptibility can be affected by

7.4 DISEASE MODELS

Figure 7.1

151

Host–agent–environment relationship.

personal characteristics such as occupation, income, education, immune status, behavior, and genetic traits. The presence (or absence) of the agent is necessary for disease to occur (or be prevented). The environment must support the agent, and the agent must be transmitted to a susceptible host in an appropriate time, manner, and dose sufficient to cause infection and disease. For example, infection and serious illness may occur among AIDS patients when a water source is contaminated with

Figure 7.2 Causes of cholera [adapted from: Beaglehole et al. (1993)].

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EPIDEMIOLOGIC CONCEPTS

Figure 7.3 Web of causation applied to cardiovascular disease [adapted from: Rockett (1994)].

Cryptosporidium oocysts from human or animal feces, sufficient numbers of oocysts survive in the source water, the oocysts are inadequately removed or inactivated by the water system, and an infective dose of oocysts is ingested while drinking tapwater. The disease process is often complex, and this complexity can be illustrated in a more detailed model, sometimes referred to as the ‘‘web of causation.’’ The relationship between water exposures and other risk factors for cardiovascular disease is shown in Fig. 7.3. This model places less emphasis on the role of the agent or water contaminant in favor of other factors that may be important in the onset of disease. Epidemiologists have found lower cardiovascular disease mortality in areas where water hardness (e.g., levels of calcium and magnesium) is high, and some studies have associated water constituents with decreased blood pressure. However, evidence is not yet available to fully understand the role of water constituents or where to place this exposure within the web of causation. Thus, the use of a dotted line is shown for water exposures in Figure 7.3. Additional research is required to better understand how water constituents may affect cardiovascular disease or blood pressure.

7.5

BASIC MEASURES OF DISEASE FREQUENCY

To evaluate and compare disease and other health conditions in populations, epidemiologists use several measures of disease frequency. The most important are disease prevalence and incidence. Incidence measures the rate at which new cases of disease occur in a group of people who do not have the disease during a defined period of time; prevalence measures both new and existing cases in a population with and without disease (Last 1995, Beaglehole et al. 1993). A meaningful measure

7.5 BASIC MEASURES OF DISEASE FREQUENCY

153

of disease frequency requires the accurate compilation of cases of disease (the numerator) and an estimate of the susceptible population or population at risk (the denominator). The cases of disease must all arise from the population at risk. Although often referred to as a ‘‘rate,’’ prevalence is the proportion of people in the population who have a specific disease, condition, or infection at any specified time (e.g., on Jan. 1, 1996, or during Jan. 1–May 31, 1995). For example, a stool survey in Washington State estimated a 7% prevalence of giardiasis during 1980 in young children in diapers (Harter et al. 1982). The incidence rate requires an estimate of the amount of time people are at risk of contracting the disease, and person– time is specified in the denominator. For example, in a cohort of 118,539 women, 30–55 years of age, free from coronary heart disease and stroke in 1976, and followed for almost 8 years, 274 stroke cases were identified during the 908,447 person-years of follow-up (Beaglehole et al. 1993). In this study, the overall incidence rate of stroke in females was 30.2 per 100,000 person-years [computed as (274=908,447)
(100,000)]. Incidence can be compared among populations, and in this cohort the incidence of stroke was studied among smokers, ex-smokers, and nonsmokers. The incidence rate of stroke among current women smokers (49.6=100,000 person-years) was almost 3 times the nonsmokers’ rate (17.7= 100,000 person-years) and almost twice the ex-smokers’ rate (27.9=100,000 person-years). Incidence can be estimated from prevalence data when the average duration of disease is known, as prevalence is approximately equal to the incidence rate times the average duration of illness. The attack rate measures the cumulative incidence of disease in a particular group observed for a limited time and under special circumstances (i.e., during an epidemic or outbreak). The period of time for observation of cases can vary but should begin at the presumed time of exposure and continues over a time interval that allows for the occurrence of all possible cases that may be attributable to the exposure. In communicable disease outbreaks, secondary transmission can occur. The secondary attack rate refers to cases among familial, institutional, or other contacts following exposure to a primary case; the denominator includes only susceptible contacts. An example of the potential importance of secondary transmission is provided by an outbreak of E. coli 0157:H7 gastroenteritis caused by consumption of contaminated, undercooked hamburger (Grimm et al. 1995). In waterborne outbreaks caused by E. coli 0157:H7, Norwalk-like viruses, and Cryptosporidium, secondary transmission of infection and illness have been documented among personal contacts with primary cases. Waterborne etiologic agents such as these, which have a low infectious dose, are often transmitted by person-to-person contact, and a search should be conducted for secondary cases even though the primary cases may have been transmitted by contaminated water. The number of secondary cases may exceed the number of primary cases. Geography-specific (Kent et al. 1988) and food-specific attack rates are frequently used to help identify the vehicle or mode of transmission of disease during an outbreak investigation (Tables 7.1–7.3). For example, area-specific attack rates for populations were used to help identify the source of contamination in a waterborne outbreak of giardiasis in Pittsfield, MA (Kent et al. 1988). Attack rates were 4–5 times higher in populations served exclusively by reservoir C than in those served by

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EPIDEMIOLOGIC CONCEPTS

TABLE 7.1 Geography-Specific Attack Rates from a Waterborne Outbreak of Giardiasis in Massachusetts Water Source

Cases

Population

Attack Rate per 1000

Reservoir A Reservoir B Reservoir C Mixed

68 14 126 427

9405 2309 4200 34,351

7.2 6.1 30.0 12.4

Total

635

50,265

12.6

Source: Kent et al. (1988).

reservoirs A and B (Table 7.1). In an outbreak in Milwaukee, MacKenzie et al. (1994) found that the attack rate for watery diarrhea was higher among persons living in the area served by the Milwaukee Water Works (39%) than in those living outside this area (15%). The Water Works service area receives water from two different treatment plants, and the attack rate was also found to be higher in the

TABLE 7.2 Dose–Response Attack Rates from a Waterborne Outbreak of Chronic Diarrhea Water Consumption during Outbreak (Glasses)

Attack Rate per 100

1–10 11–30 >30

12.5 37.5 57.1

Source: Parsonnet et al. (1989).

TABLE 7.3 Outbreak

Hypothetical Vehicle-Specific Attack Rates during a Waterborne Ate or Drank

Did Not Eat or Drink

Item

Ill

Not Ill

Attack Rate per 100 (a)

Water Coffee Fruit cup Beef

60 40 25 30

20 30 40 40

75 57 38 43

a

For instance, risk ¼ 75=13 ¼ 5.8.

Ill 4 19 17 20

Not Ill

Attack Rate per 100 (b)

Risk (a=b)

26 21 28 20

13 48 38 50

5.8a 1.2 1.0 0.9

7.5 BASIC MEASURES OF DISEASE FREQUENCY

155

southern area (52%) than in the northern area (26%). Contamination was suspected to have entered the water system at the southern treatment plant. Attack rates can also be computed based on estimated water consumption (Parsonnet et al. 1989). In an outbreak of chronic diarrhea, the attack rate was higher among ill person who consumed more water (Table 7.2). Hypothetical food-specific attack rates presented in Table 7.3 illustrate the typical methodology used to identify the vehicle responsible for an outbreak. In this example, water is implicated because the rate of illness among those who drank water was almost 6 times greater than the rate of illness among those who did not drink water, while attack rates were similar among those who did or did not consume other foods or beverages that may have been possible vehicles of infection. Mortality and case–fatality rates are also important measures of disease frequency. The mortality rate is a measure of deaths from a select disease or from all causes in a given period, usually a calendar year. The denominator is the average total population in which the deaths occurred, and the number of deaths is usually multiplied by 100,000 (or another multiple of 10) to produce a rate per 100,000 people. The case–fatality rate is the percent of individuals diagnosed with a specific disease who die as the result of that disease. For example, Bennett et al. (1987) report a case–fatality rate of 0.2% for shigellosis, a bacterial disease that may be waterborne. Although a lower case–fatality rate is reported (Bennett et al. 1987) for campylobacteriosis, another bacterial disease that may be waterborne, the mortality rate for campylobacteriosis is higher than that for shigellos because its incidence is higher (Table 7.4). Mortality and morbidity frequency may be determined for the total population (usually called an overall or crude rate) or for specific groups in the population. The crude rate is not used to evaluate long-term health trends or compare the health of different population groups because it does not take into account demographic characteristics, such as age, gender, and race, which may differ among the groups. An age-, gender-, or race-specific rate can be computed for comparison purposes or the crude rate can be standardized using a weighted averaging of specific rates. For example, an age-adjusted rate is a summary measure of the disease rate a population would have if it had a standardized age structure. Table 7.5 illustrates how use of crude rates can be misleading. In Finland, the crude mortality rate for diseases of the

TABLE 7.4 Estimated Incidence and Mortality for Campylobacteriosis and Shigellosis, 1985, USA Disease

Incidence (person-years)

Case–Fatality Rate (%)

Mortality

Mortality Rate

Campylobacteriosis

883.8=100,000

0.1

2100

Shigellosis

126.3=100,000

0.2

600

8.8 per 100,000 people 2.5 per 100,000 people

Source: Bennett et al. (1987).

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TABLE 7.5 Mortality for Diseases of the Circulatory System, 1980, Finland and Egypt Country

Crude Rate

Age-Adjusted Rate

Age-Specific Ratea

Finland Egypt

491=100,000 192=100,000

277=100,000 299=100,000

204=100,000 301=100,000

a

For subjects aged 45–54 years. Source: Beaglehole et al. (1993).

circulatory system is higher than in Egypt (Beaglehole et al. 1993), but the ageadjusted or age-standardized rate is higher in Egypt. This is because Finland has a larger proportion of older people. Age-specific rates show that mortality is higher among 45–54-year-old persons in Egypt than in Finland. Knowing the frequency or magnitude of disease in the population is just the beginning of the epidemiologist’s search. Time, place, and person must be considered to identify possible associations, risk groups, and risk factors. The collection of this information provides the general framework for an effective disease surveillance system. Knowing the time of disease occurrence assists epidemiologists in the detection of outbreaks, assessment of possible exposures that may have occurred, and evaluation of seasonal and long-term disease trends. For example, laboratory surveillance of stool specimens for Cryptosporidium parvum alerted health officials in Jackson County, Oregon, to an unusual number of cases; in the first 4 months of 1992, 46 cases of cryptosporidiosis were reported compared to 27 cases for all of 1991. The subsequent investigation identified waterborne transmission (Oregon Health Division 1992). Knowledge of the place of disease occurrence can help detect clusters of disease and allows the epidemiologist to compare disease rates among various geographic areas, such as countries, states, counties, census tracts, institutions, or water service districts. Information about people who become ill (e.g., through exposure) and their demographic characteristics is necessary to develop and test hypotheses about exposure–disease associations (Craun 1990, IAFMES 1996).

7.6

TYPES OF EPIDEMIOLOGIC STUDIES

Both observational and experimental studies have been conducted for drinking water exposures (Table 7.6). Experimental studies include population intervention studies and clinical trials of the efficacy of medications, medical therapies, and public health controls. Both studies consider the effect of varying some characteristic or exposure that is under the investigator’s control. Comparable individuals are assembled, randomly assigned to a treatment or intervention group, and observed for disease outcome, much as in a toxicologic study. The major difference is that experiments in human populations seek only cures or ways to help prevent disease. Ethical concerns must be fully addressed, and risks must be carefully weighed

7.6 TYPES OF EPIDEMIOLOGIC STUDIES

TABLE 7.6

157

Types of Epidemiologic Studies

Experimental Clinical Population Observational Descriptive Disease surveillance and surveys Correlational or ecological Analytical Longitudinal Cohort or follow-up Case–control Cross-sectional Source: Adapted from Monson (1980).

against potential benefits. Examples of clinical and population experimental studies with results of interest to water officials are available (DuPont et al. 1995; Chappell et al. 1996; Dann et al. 2000; Okhuysen et al. 1998; Frost and Craun 1998; Muller et al. 2001; Ward et al. 1986; Moe et al. 1999; Payment et al. 1991, 1997). To determine the median infective dose of C. parvum, healthy volunteers without evidence of previous infection were randomly assigned to receive a specified dose of oocysts and then monitored for oocyst excretion and clinical illness for 8 weeks (DuPont et al. 1995). Additional clinical studies have provided more information about infection and the immune response for Cryptosporidium (DuPont et al. 1995, Chappell et al. 1996, Dann et al. 2000, Okhuysen et al. 1998, Frost and Craun 1998, Muller et al. 2001) and other waterborne pathogens such as rotavirus and Norwalklike viruses (Ward et al. 1986, Moe et al. 1999). In a population experimental study conducted in the Montreal area, endemic waterborne disease risk was evaluated by monitoring enteric disease in households that had been randomly assigned to one of two groups—one consuming municipal tapwater and the other receiving tapwater further treated by reverse osmosis to remove microbial contaminants (Payment et al. 1991). In a second study, Payment et al. (1997) included for comparison purposes a bottled water group and a group where water was flushed through the household plumbing before use. Observational studies are either descriptive or analytical. In descriptive studies information is available only about the occurrence of disease (from surveillance systems or special surveys) or associations among exposures, demographic characteristics, and disease rates in population groups (ecological studies). Descriptive epidemiology is important for summarizing disease information (e.g., cancer incidence rates) to reveal temporal, demographic, and geographic patterns of occurrence and develop hypotheses about disease etiologies and risk factors, whereas analytical epidemiology is used to test specific hypotheses. Descriptive techniques are also used to detect outbreaks (e.g., an active surveillance system for cryptosporidiosis), but analytical studies are required to evaluate exposure–disease associations and

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confirm the mode of transmission during the outbreak investigation (Craun 1990, IAMFES 1996). Analytical studies (or population experimental) studies are also required to determine endemic waterborne disease risks. Disease surveillance, no matter how complete the reporting, is inadequate by itself to assess waterborne risks (Craun 1994). 7.6.1

Ecological Studies

Ecological (also called correlational or aggregate) studies are used by epidemiologists to explore associations between health statistics, demographic measures, and other information (e.g., environmental monitoring results) readily available from vital statistics and public records. The ecological study is inexpensive and, as noted in our earlier example, straightforward; however, the interpretation of associations from this analysis is fraught with problems. In ecological studies, health and demographic statistics characterize population groups, rather than the individuals within the groups, and serious errors can result when it is assumed that inferences from a descriptive analysis pertain to the individuals within the group. Often group inferences do not pertain to individual behaviors and exposures, especially waterborne. Neither theoretical nor empirical analyses have offered consistent guidelines for the interpretation of results from ecological studies, and associations found in these studies must be viewed with appropriate caution (Greenland and Robins 1994a, 1994b; Piantadosi 1994). Ecological studies usually provide information to help develop hypotheses for additional study. In some instances, however, the group may be the appropriate unit of study, especially when the disease has a relatively short incubation or latent period and group exposures are shown to be relevant for individuals in the group (Poole 1994; Susser 1994a, 1994b; S. Schwartz 1994, J. Schwartz 1995). Epidemiologists should describe the limitations of their ecological study or why the results are appropriate for assessing risks. Between 1974 and 1982, more than 15 ecological studies associated cancer mortality and incidence with chlorinated drinking water in various locations in the United States (Craun 1993, IARC 1991). Cancer statistics, primarily mortality data for various cancers, were obtained for counties and sometimes census tracts; drinking water exposures for populations in the census tracts or counties were assessed from readily available information about water sources (ground or surface), disinfection practices, and occasionally trihalomethane levels; some demographic information was usually available to describe the population groups (e.g., educational background, nationality, urbanicity). In most studies, cancer mortality, for all and several specific sites, was found to be higher in areas where chlorinated surface water was used than in areas where unchlorinated groundwater was used, but it is difficult to interpret these associations. Are the observed associations due to exposure to chlorinated water, chlorinated byproducts, other contaminants in surface water, or other exposures or characteristics that were not assessed? For example, urban areas generally have higher cancer mortality rates because urban populations have opportunities for other exposures that might also be associated with cancer mortality and may be more likely to be correctly diagnosed with cancer. Urban areas also

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frequently use surface water sources that are almost always chlorinated. Thus, it is difficult to determine with any certainty from these studies whether cancer mortality was causally or merely statistically associated with chlorinated surface water. Chlorinated surface water might serve as a surrogate for another characteristic(s) that is a cause of the observed cancer mortality. In addition, the association was nonspecific, as a variety of cancer sites were implicated. The primary value of these studies was to develop hypotheses for further study by analytical epidemiology. Analytical studies are able to provide both information about possible causal associations and the magnitude of the risk. In contrast to ecological studies, individuals within a population group or geographic area are selected for study. For each study participant, information is obtained about the person’s disease status, exposure to possible risk factors, and other demographic characteristics. Analytical studies can be either longitudinal or cross-sectional (Monson 1980). In a longitudinal study, the time sequence can be inferred between exposure and disease; that is, exposure precedes disease (Monson 1980). In a cross-sectional study, the data on exposure and disease relate to the same time period, making this type of study useful primarily for diseases with a short latent or incubation period. For example, the frequency of serological responses to Cryptosporidium antigens can be measured from sera collected from a cross-sectional survey, and information about sources of drinking water and other recent exposures can be related to the presence of a serological response to the antigens (Frost and Craun 1998; Frost et al. 1998, 2000a, 2000b). Cross-sectional studies can also provide important information for generating hypotheses and for interpreting potential causes of an outbreak. A good example is the cryptosporidiosis outbreak that occurred among residents and visitors to Collingwood, Ontario, during March 1996 (Frost et al. 2000a). The low level of reported diarrheal illness among adult Collingwood residents caused government officials and physicians to question whether an outbreak had occurred. A serological survey found evidence that Collingwood residents were likely to have been infected at the time of the outbreak but did not suffer illness from the infections. A high level of endemic infections prior to the outbreak may have protected Collingwood residents, whereas unprotected nonresidents who drank Collingwood water suffered high attack rates of illness. Longitudinal studies (Monson 1980) are of two distinct and opposite approaches: (1) the cohort study, which begins with an exposure or characteristic of interest and seeks to determine disease consequences of the exposure or characteristic; and (2) the case–control study, which begins with a disease or health condition of interest and seeks information about risk factors and possible exposures. A cohort study is also called a follow-up study. Individuals enter the cohort solely on the presence or absence of certain characteristics, a specific event, or their exposure status (e.g., chlorinated or unchlorinated water; high, moderate, low, no levels of arsenic in water). An advantage of this study is that any number of appropriate health-related outcomes or diseases can be assessed during the follow-up period. Morbidity or mortality incidence rates are determined for various diseases and compared for the exposed and unexposed groups in the cohort. A fundamental requirement is that the investigator not know the disease status of any individual when the cohort is

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assembled. A cohort can be based on currently defined exposures (e.g., disinfection byproducts or Cryptosporidium levels in water in March 1996) and followed forward in time. Determining possible cancer risks associated with a currently defined exposure (e.g., to disinfection byproducts), however, will require that the cohort be followed for many years into the future. To evaluate Cryptosporidium infection, the cohort can be followed for a much shorter time period. An alternative design for diseases with a long latency period is to assemble a historical cohort based on known exposures at some previous point in time. The follow-up period should be appropriate; that is, a sufficient time should be considered on the basis of the anticipated latency of the disease. For example, if a cohort could be established in terms of known drinking water exposures in 1970 (e.g., to disinfection byproducts), over 25 years of exposure would have already occurred, and the follow-up period would be relatively short. A special kind of cohort study, community intervention studies, can be conducted when a community changes water treatment or sources to improve their water quality. The study is prospective in nature and is conducted during a period before and after the water source or treatment change. Both individual level and community level illness and water exposure information can be collected, either in a longitudinal or cross-sectional study. This type of study has been used to determine enteric disease rates before and after water treatment changes, the relative source contribution of drinking water to community illness rates, and etiologic agents responsible for the observed illness (Calderon and Craun 2000). For comparison purposes, a similar study should also be conducted in a nearby control community that is demographically similar but is not undergoing a change in its water source or treatment. The primary advantage of this type of study is that water quality is improved at all places where persons may consume water (e.g., home, school, work, restaurants) and exposure misclassification is minimized. The household intervention study, as described previously, evaluates the change in water quality only for water consumed at the home, and this may only be a fraction of the water consumed throughout the day by study participants. Other important advantages are that a timeseries analysis of changes in health status can be conducted and that a large number of routinely collected community health surveillance data (e.g., clinical surveillance, hospital admissions, school absences, nursing home illness) can be evaluated in addition to longitudinal and cross-sectional data for diarrheal illness, etiological agents, and serological responses. Illnesses and risk factor data can be collected from participating families by daily diaries and=or telephone surveys. Crosssectional data for illness and risk factors can also be collected by periodic telephone surveys. Also, specific water treatment changes of interest (e.g., health improvements associated with surface water filtration) can be evaluated. A major limitation is that, for most community-level health changes, only relatively large changes can be detected. Since the studies must be conducted in areas considering changes, the areas may not be optimal in terms of water quality or population characteristics. Another limitation is the generalizability of results. Since the studies focus on specific water sources and treatment changes, results may not be generalized to the entire U.S. population; however, the findings may be applied to populations using similar water

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sources and treatment. Furthermore, since people chronically exposed to a water supply may develop some protective immunity to endemic microbes, this type of study may not detect health risks that affect people without prior exposures, such as young children or new residents. In a case–control study (also called a case-comparison or case-referent study), individuals enter the study solely on the basis of disease status without knowledge of their exposure status. A single disease or health outcome (e.g., giardiasis, cryptosporidiosis, lung cancer, bladder cancer, blood lipid levels) is usually selected for study. Individuals with the particular disease or infection are selected during a specified time period within a defined geographic area or from selected hospital(s), clinic(s), or a specified cohort. A comparison group of individuals in which the condition or disease is absent (the controls) is selected, preferably randomly, from the same population in which the cases arise. Existing or past attributes and exposures thought to be relevant in the development of the disease are determined for all study participants (cases and controls). Because previous exposures are determined, a case–control study is sometimes referred to as a retrospective study. Information about any number of individual exposures or behavior (e.g., smoking, use of chlorinated or unchlorinated water, arsenic exposures) can be obtained. The frequency of exposure is compared for individuals with and without the disease to determine possible associations with the disease being studied. Case–control studies have provided a major contribution to our understanding of the causes of many diseases and are frequently used in outbreak investigations. This study design is usually more efficient than the cohort study, requires fewer study participants for adequate statistical power, and is often considered as the first option when studying risk factors. However, information on exposures must usually be obtained by questionnaire (e.g., spouses or parents of cases), and it is often difficult to accurately assess exposures that may have occurred many years ago. Ensuring that the quality and accuracy of information about exposures are similar for cases and controls is difficult.

7.6.2

Time-Series Analyses

A variation of the cohort approach and ecologic study is the time-series analysis. The time-series analysis has been used to relate water quality events (e.g., turbidity) to disease. The study is relatively inexpensive when routinely collected data are used, and it considers the health outcome for the community as a whole, including secondary effects. The community being studied serves as its own control. Both the background level of disease and water quality vary over time, and at least one year of data should be collected for disease and water quality so that seasonal changes can be assessed. The method considers time lags between exposure and the outcome. A time lag is important for waterborne infectious diseases because etiologic agents have different incubation periods ranging from 24 hours to several weeks or more. A major advantage is that the method tends to eliminate many possible confounding factors. For a factor to confound the association, it must vary in a similar way as water quality data, and most important confounders are not likely to vary in the same way as a water quality parameter. However, if higher levels of turbidity occur in the

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EPIDEMIOLOGIC CONCEPTS

fall and winter, then seasonal risk factors for gastrointestinal disease could confound results from these studies. The incidence of gastroenteritis often varies with season of the year, and thus, the analysis should adjust for possible seasonal effects. Water quality data that can be evaluated include turbidity, coliform analysis, other routinely collected data, or pathogen-specific analyses. Disease measures include emergency room visits, physician visits, routinely collected illness surveillance data, and serological data. The advantage of these studies is that they can, theoretically, detect very small relationships between changes in water quality and illness. This occurs because of the large number of physician visits for gastrointestinal events. A major disadvantage of these studies involves the interpretation of the findings because of uncertainties about the observed associations. In addition, as the measures of exposure tend to be imprecise, it is not yet certain which measures of water quality or health data are most appropriate to include. The studies are also difficult to apply to small systems. Risks will be specific to source waters, type of treatment, susceptibility of distribution systems to contamination, individual susceptibility to disease, and water consumption patterns. It should be recognized that water quality and many of these factors change over time. The methodology has been applied successfully to the evaluation of an outbreak; Morris et al. (1996) evaluated whether previous unreported outbreaks of gastroenteritis had occurred in Milwaukee, the site of a filtered water system in which a large outbreak of cryptosporidiosis had occurred. However, several other studies that used a similar statistical methodology have caused considerable controversy. An study (Aramini et al. 2000) investigated the association between gastrointestinal outcomes in Vancouver, as assessed by hospitalizations, physician visits, and visits to the British Columbia Children’s Hospital emergency room, and water quality parameters, including turbidity and fecal coliform bacteria. Vancouver uses surface water without filtration. An association was found for these gastrointestinal outcomes and water turbidity; relative risks increased as turbidity increased. No association was reported between risk of illness and fecal coliform levels or rainfall. Studies in the United States have also reported an association between drinking water turbidity and gastrointestinal illness in the absence of an outbreak (Schwartz and Levin 1999; Schwartz et al. 1997, 2000). The studies evaluated very low turbidity levels in a filtered surface water supply. When published, the initial Schwartz et al. (1997) study received much criticism. Major concerns included the use of turbidity as a proxy or surrogate measure for risk of microbial contamination, exposure misclassification, and whether the observed turbidity associations are causal. Few epidemiologists accept that these studies have shown, beyond a reasonable doubt, a quantitative, casual association between waterborne diarrheal illness risk and water turbidity. However, the time-series analysis shows promise and will likely continue to be conducted, hopefully with improvements in exposure assessment. 7.6.3

Random and Systematic Error

A study must be of sufficient size and statistical power to detect the expected association. The association observed in each study must be evaluated to determine

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163

that systematic and random errors are not responsible (Table 7.7). Systematic error or bias affects the validity of a study’s observed association. Random error, a measure of the precision of the risk estimate, is governed by chance. Systematic error can occur in the design and conduct of the study, leading to a false or spurious association or a measure of risk that departs systematically from the true value. Systematic error must be avoided or controlled, and when possible, its likely effect should be assessed. The likelihood that a positive association is due to random error can be estimated by calculating the level of statistical significance ( p value) or confidence interval (CI). In epidemiology, the CI is the preferred measure of random error because it provides a range of possible values for the risk estimate. It should be remembered, however, that random error or chance can never be completely ruled out as the explanation for an observed result and that statistical significance does not imply causality, biological significance, or lack of systematic error. To help interpret a negative association, statistical power calculations should be provided to specify the minimum risk a study was able to detect. Potential sources of systematic error include observation, selection, misclassification, and confounding bias. When the study population is not randomly selected or criteria used to enroll individuals in the study are not comparable for exposed and unexposed individuals or cases and controls, the observed exposure–disease association may be due to selection bias. Selection bias occurs only in study design and must be prevented because it cannot be corrected for in the analysis. To prevent selection bias, the study population must be randomly selected, exposed and unexposed groups must be selected without knowledge of their disease, or cases and controls must be selected without knowledge of their exposure. Observation bias results when disease or exposure information is collected differently from exposed and unexposed groups or cases and controls, respectively. Selective or differential recall of cases or controls about exposure will also result in a biased estimate of risk. For example, people with an illness, especially one that is severe, are more likely than persons without illness to better remember past events and possible exposures. Persons may also provide misleading information, especially when they believe that drinking water or food from a particular restaurant is the source of illness. Blinding study participants and=or investigators about the hypothesis being tested (if possible) and maintaining objectivity in collecting information can help minimize observation

TABLE 7.7 Considerations for Interpreting Epidemiologic Associations Lack of Random Error (Precision) Study size and statistical power

Lack of Systematic Error (Validity) Selection bias Misclassification bias Observation bias Confounding bias

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EPIDEMIOLOGIC CONCEPTS

bias; however, this is often difficult to do, especially in case–control studies conducted during highly publicized outbreak investigations. Neugebauer and Ng (1990) discuss differential recall as a source of bias in case–control studies and present ways to remedy this problem. Media speculation about a waterborne source of the outbreak may occur shortly after outbreak identification, and this may, at the minimum, prompt cases to more completely recall tapwater consumption habits. Persons may also report illness symptoms because of a perceived risk from drinking water causing selection bias. An objective case definition that includes laboratory confirmation may decrease the total number of cases but will increase study precision. Tapwater consumption patterns may also change as a result of media speculation. Even if cases correctly report tapwater consumption prior to their illness, controls may report less tapwater consumption if they have reduced or eliminated tapwater consumption as a result of the outbreak publicity. The effect of differential recall may be more pronounced when the date of onset of illness was many weeks previous to their interview. For example, the reported association between illness with the use of tapwater compared to the exclusive use of bottled water in Clark County, Nevada, may have been affected by recall bias. Information was obtained from interviews of HIVinfected persons with and without cryptosporidiosis (Craun et al. 2001, Goldstein et al. 1996). Interviews were conducted approximately 100 days after the onset of illnesses. Cases were asked about bottled water consumption for the time prior to their illness, and controls were asked about bottled water consumption for a similar time period. Because of media speculation, it is possible that cryptosporidiosis cases who consumed primarily bottled water for the past year may have been more likely to recall occasional use of tapwater prior to the onset of their illness than would less motived persons who did not have cryptosporidiosis. Recall bias of this type would inflate estimates of waterborne illness risk. To help assess possible recall bias in a situation like this, efforts can be made to verify bottled water consumption of cases and controls, and additional questions should be asked to determine how bottled water users avoided exposure to tapwater. An erroneous diagnosis of disease or erroneous classification of a study participant’s exposure can result in misclassification bias and a poor or incorrect estimate of risk. The probability of misclassification may vary in either a differential or nondifferential manner among the groups under study. Nondifferential misclassification will almost always bias a study toward not observing an association when one may actually be present or underestimating the magnitude of the association. Differential misclassification bias can also result in misleading, incorrect associations that either under- or overestimate the magnitude of risk. In environmental studies where the magnitude of the association is often small, accurate assessment of exposure is critical, as the impact of misclassification can be severe. Exposure must be carefully assessed, so the possibility of nondifferential misclassification bias will not be cited as a general explanation when a small or no association is observed—specifically, ‘‘we observed no association but this does not rule out the possibility of an association; nondifferential misclassification of exposure may have occurred and this will bias a study toward the null hypothesis’’ or ‘‘the magnitude of the association may be

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larger than the one observed because of nondifferential misclassification bias that could not be completely avoided.’’ The imprecise nature of the exposure estimate is a major problem, and more evaluation of routinely collected data is needed to determine if misclassification of exposure or disease is differential or non-differential. Greenland (1988) believes that epidemiologists should not presume that misclassification is nondifferential in environmental studies, and evidence should be provided to support the assertion that misclassification bias is nondifferential. Before initiating an environmental study, investigators should carefully evaluate how exposures will be assessed, and no study should be conducted unless the assessment is expected to be reasonably appropriate and accurate. This simple rule of thumb, if followed, can avoid much of the confusion surrounding the interpretation of results of poorly designed studies. For example, in five case–control studies of bladder and colon cancer risks associated with chlorinated drinking water, exposure was assessed only from information available from a death certificate (IARC 1991). Address at death, birth, or usual address was used to determine previous long-term exposures to chlorinated water. Because of the frequent migration occurring in the past 50 years, it is likely that study results were biased by the misclassification of exposure to chlorinated water. In two of the five studies, an increased risk of bladder cancer was reported, and in three studies an increased risk of colon cancer was reported. Some interpreted these results as evidence for an association between chlorinated drinking water and cancer and cited random misclassification bias as a possible reason an association was not observed in all of the studies. Others interpreted the results of the five studies as not meaningful, citing the possibility of nonrandom misclassification bias (i.e., it could not be determined if bias over- or underestimated the risk). Either interpretation is plausible. However, without additional data, epidemiologists should not assume that the studies found no association because of random misclassification of exposure. Confounding bias may convey the appearance of an association; that is, a confounding characteristic rather than the putative cause or exposure may be responsible for all or much of the observed association. A confounding characteristic can cause or prevent the disease, is not on the causal pathway from exposure to disease, and is associated with the exposure being evaluated. An example of a confounding characteristic is provided by Monson (1980). Cigarette smoking is a cause of lung cancer, and it is also associated with heavy alcohol consumption. In studying lung cancer, an association was observed between heavy drinking and lung cancer; that is, the lung cancer rate was greater in heavy drinkers than in nondrinkers. Alcohol drinking probably does not directly cause lung cancer, and the observed association between drinking and lung cancer is likely caused by confounding bias of cigarette smoking. Confounding bias does not necessarily result from any error of the investigator. It is potentially present in all studies and must always be considered as a possible explanation for any observed association. If a characteristic can be made or demonstrated to have no association with exposure or disease, that characteristic cannot confound the association between exposure and disease. For example, in a study of radon exposure and lung cancer, smoking would not cause confounding bias in a study where smoking habits were similar among radon-

166

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exposed and unexposed persons. During study design, confounding bias can be prevented or minimized by matching cases and controls for specific characteristics such as smoking status or randomization of study participants into exposure groups. During data analysis the following are used to assess and control confounding bias: stratification or analysis of risk estimates by various characteristics, such as age, gender, smoking status (e.g., whether risks are greater among the elderly or young, males or females, smokers or nonsmokers) and multivariate techniques, such as regression analysis. Logistic regression that considers the natural logarithm of the odds of disease is often used in studies. In multiple regression analysis, confounding can be controlled; however, it should be remembered that con-founding bias can be controlled or evaluated only for those characteristics for which information is collected. In the example of an observed association between alcohol consumption and lung cancer, a stratified analysis was used to assess the possible confounding bias of cigarette smoking (Monson 1980). Since smoking was the suspected confounding characteristic, the data were analyzed separately in smokers and nonsmokers. Smoking was associated with lung cancer, but no association was seen between alcohol consumption and lung cancer in either smokers or nonsmokers. The observed association between alcohol use and lung cancer was due to confounding bias of cigarette smoking. Not to be confused with a confounding bias, effect modification refers to a change in the magnitude of the effect of a putative cause (Last 1995). A characteristic (e.g., age) can cause confounding bias in one study and modify the risk in another study (Rothman 1996). A classic example of effect modification is the interactive effects of smoking and asbestos exposure. Smoking or asbestos exposure increase the risk of lung cancer. However, exposure to both smoking and asbestos will increase the lung cancer risk much more than would be predicted for each exposure alone. In this case smoking is an effect modifier for asbestos exposure (Kleinbaum et al. 1982). Effect modification is a finding to be reported rather than avoided (Rothman 1996). In an experimental study, randomization is possible—each individual in the study has an equal or random chance of being assigned to an exposed or unexposed group (i.e., tapwater, bottled water, or another water group). Because of this random assignment of exposure, all characteristics, confounding or not, tend to be distributed equally between groups of different exposure. This means that over the long run, if experiments are repeated and similar exposure–disease associations are observed, confounding bias is an unlikely explanation for the observed associations. Selection bias and misclassification of exposure are usually avoided because of the study design, but misclassification of disease and observation bias are still of concern. Reporting bias may be important in experimental studies where disease is self-reported or only symptoms of disease are reported, and if possible, disease status should be confirmed independently by clinical analysis. For example, because of their knowledge of the water source or treatment, persons randomly assigned to a group that receives specially treated bottled water or home filters may report symptoms or disease differently than those persons in a group using tapwater. Reporting bias can be minimized and assessed by including a group that receives bottled tapwater, and then switching the type of water received by each group midway

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through the study in an attempt to blind the participants about their water source. The intent is to eliminate biases or prejudices of the investigators and study participants. In a blinded study either the investigators or study participants or both (double-blinded) do not know to which group, experimental or control, a study participant has been assigned. Laboratory analysts may also be blinded (tripleblind). A study in California (Colford et al. 2002) evaluated the ability to blind participants in household intervention studies. The study was triple-blinded (investigators, the treatment installer, and the study participants), and the sole purpose of the study was to evaluate ability to blind subjects as to whether they had a true treatment device or a sham treatment device installed in their homes. The investigators concluded that study participants could be blinded as to whether they had a true treatment device or a sham device.

7.6.4

Measures of Association

The basic measures of an association in analytical studies are the rate difference (RD) and rate ratio (RR). The rate difference is a measure of the absolute difference between two rates, such as incidence rate of disease for the exposed minus the incidence rate for the unexposed in a study population. The rate ratio is a relative measure of two rates. The ratio of two rates, for example, incidence rate for the exposed divided by the incidence rate for the unexposed in a study population. The rate ratio is also called the relative risk (RR). A RR of unity (1.0) indicates no association or no increased risk; any other ratio signifies either a positive or negative association, provided the association is not subject to systematic error. For example, a RR of 1.8 indicates an 80% increased risk of disease among the exposed; a RR of 0.8 indicates a decreased risk or beneficial effect of 20%. Precision of the risk estimate or random error is assessed by the CI. For example, 95% CI ¼ 1.6–2.0 indicates a precise and statistically significant (the CI is narrow and does not include 1.0) estimate, whereas, CI ¼ 0.8–14.5 indicates the estimate is not statistically significant (the CI includes 1.0) and imprecise (a wide range of values). Because the selection of participants is based on their disease status in a case– control study, the odds ratio (OR) is determined rather than the RR. The OR is the odds or chance of disease among the exposed divided by the odds of disease among the unexposed and is essentially equivalent to the RR, especially if the disease is rare, such as cancer. Another important measure, the attributable risk (AR), is an estimate of the rate of a disease or other outcome in exposed individuals that can be attributed to the exposure in question, provided the association is causal. This measure is obtained by subtracting the rate of disease among the unexposed from the rate among the exposed (see rate difference) (Last 1995). Unfortunately, AR is not always consistently used by epidemiologists, and readers should be careful to understand what the investigator means when AR is reported in a study (Rothman 1996). AR among the exposed or attributable fraction (AF) exposed is used to denote the excess risk among the exposed; population AR or population AF is used to denote the excess

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EPIDEMIOLOGIC CONCEPTS

risk in the entire population, exposed and unexposed. AR is expressed as either a percent or proportion (Last 1995).

7.6.5

Strength of Association

The magnitude of the RR can help assess if an observed association may be spurious. On the basis of experience (Monson 1980), it is difficult to interpret weak associations, a RR of less than 1.5 (Table 7.8). One or more confounding characteristics can easily lead to a weak association between exposure and disease, and it is usually not possible to identify and adequately measure or control weak confounding bias. On the other hand, a large adjusted RR is unlikely to be completely explained by an unidentified or uncontrolled confounding factor. When the study has a reasonably large number of participants and the adjusted RR is large, random error and confounding bias are less likely to be responsible for an observed association. The magnitude of a RR, however, has no bearing on the possibility that an association is due to observation, selection, or misclassification bias. Any of these biases can lead to a total misrepresentation of an observed association. Since a RR of <1.5 is frequently observed in environmental studies, results of these studies usually cause considerable controversy about whether the observed association represents a real risk or is due to bias. As discussed earlier good-quality exposure assessment measurements and study design are important to interpret risks of this magnitude.

7.6.6

Causality of an Association

Interpretation of data should be made with caution and in the context of all relevant scientific information about the disease and its etiology. No single study, even one with little systematic error, can provide a definitive answer about the exposure– disease association. Results from several studies of different design and different population groups allow a more definitive conclusion, and it may be necessary to consider studies in both the general and special populations. Judging causality in epidemiology is based on guidelines (Beaglehole et al. 1993, Craun 1990, Rothman 1996, Hill 1965), which include  Temporal Association. Exposure must precede the disease, and in most studies this can be inferred. When exposure and disease are measured simultaneously, it is possible that exposure has been modified by the presence of disease.  Strength of Association. The larger the RR or OR the less likely the association is to be spurious or due to confounding bias. However, a causal association should not be ruled out simply because a weak association is observed.  Consistency. Repeated observation of an association under different study conditions supports an inference of causality; however, its absence does not rule it out.

7.6 TYPES OF EPIDEMIOLOGIC STUDIES

169

 Specificity. A putative cause or exposure leads to a specific effect. The presence of specificity argues for causality, but its absence does not rule it out.  Biological Plausibility. When the association is supported by evidence from clinical research or basic sciences (e.g., toxicology, microbiology) about biological behavior or mechanisms, an inference of causality is strengthened.  Dose–Response Relationship. A causal interpretation is more plausible when an gradient is found (e.g., higher risk is associated with larger exposures).  Reversibility. An observed association leads to some preventive action, and removal or reduction of the exposure leads to a reduction in or risk of disease. The inference that an association is causal may be controversial, and epidemiologists have debated how scientific evidence should be evaluated in an attempt to better understand causal inferences. Even when repetitions of an association are observed, questions may remain as to whether these associations really constitute an ‘‘empirical demonstration that serves as a valid platform for (causal) inference’’ or whether ‘‘the process is still steeped in uncertainty’’ (Rothman 1986). Thus, when environmental policymakers and regulators are confronted with associations that suggest the need for action, they must be aware of any uncertainties. Scientific evidence is often conflicting, and the type of evidence or studies that are considered in the evaluation must be given due weight on the basis of issues mentioned previously (i.e., study design, study precision, study validity). Unfortunately for environmental issues, this is a rarely conducted exercise. As the literature grows for many drinkingwater-related studies, more efforts to evaluate causality should be undertaken.

7.6.7

Meta analysis

A meta analysis is sometimes conducted to summarize the results from a group of studies of a related hypothesis (Greenland 1994, Morris et al. 1992, Craun et al. 1993, Anonymous 1992). A frequent application of metaanalysis has been the pooling of results from a number of small randomized controlled clinical trials. By combining studies (usually of identical or similar design), problems associated with the use of small study populations can be overcome and a more precise estimate of risk can potentially be obtained. Generally, a complete, systematic literature review and evaluation of the quality and consistency of findings among the studies TABLE 7.8 Guide to the Strength of an Epidemiologic Association Rate Ratio 1.0 1.0–1.5 1.5–3.0 3.1–10.0 >10.0

Strength of Association None Weak Moderate Strong Infinite

Source: Adapted from Monson (1980).

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EPIDEMIOLOGIC CONCEPTS

is also conducted. This methodology has been applied to observational studies. For example, a meta analysis of 10 observational studies reported a small increased risk of bladder (RR ¼ 1.21) and rectal (RR ¼ 1.38) cancers associated with chlorinated drinking water (Morris et al. 1992, Craun et al. 1993). This example illustrates the problem of applying meta analysis to observational studies. The analysis failed to evaluate the quality of the individual studies included, consider the differences in study design, or adjust for differing approaches to exposure assessment and confounding and thus contributed very little to our understanding of the observed associations between chlorinated water and cancer (Craun et al. 1993). The utility of a meta analysis to provide a summary risk estimate for observational studies of water disinfection and cancer risk continues to be questionable (Anonymous 1992, Bailar 1995, Poole 1997).

7.7 EXAMPLES: EXPERIMENTAL, COHORT, AND CASE–CONTROL STUDIES Examples of several types of drinking water studies are presented to illustrate study design issues, potential biases, and how to compute measures of association. 7.7.1

Experimental Studies

Microbial Risks. In a population experimental study (Payment et al. 1991) conducted near Montreal, it was estimated that up to 35% (AR exposed) of self-reported, mild, gastrointestinal illness experienced by tapwater consumers over a 15-month period was waterborne; 607 households were randomly assigned to either a group consuming municipal tapwater or a group receiving tapwater further treated by reverse osmosis and monitored for enteric illness (Table 7.9). The water source was a river source contaminated with sewage and treated with predisinfection, coagulation, flocculation, rapid sand filtration, ozone, and chlorine. The tapwater met all current microbiological and physical limits, and no outbreak of illness was reported during the study. Study results reported in Table 7.9 illustrate how measures of association (RD, RR, and AR exposure) between drinking water exposure and gastroenteritis incidence were computed. Highly credible gastroenteritis episodes were defined as those that involved either of the following combination of symptoms: vomiting or liquid diarrhea or nausea, soft diarrhea combined with abdominal cramps, and staying home from work or school or visit to a physician. A similar study was conducted a few years later (Payment et al. 1997) and found an AR of 14% of symptomatic gastroenteritis was related to drinking water. A population experimental study in Australia (Hellard et al. 2001) found no difference between exposed and unexposed families and concluded that drinking water contributed little, if any, to gastroenteritis in the community. Additional studies are currently (2003) being conducted in the United States to better define the magnitude of endemic waterborne disease risk associated with various water sources. It is possible that

171

1.00 0.64

Study Period

3=88–6=88 9=88–6=89 0.65 0.43

Reverse-Osmosis Filtered Tapwater (b) 0.35 0.21

Risk Difference (RD ¼ a 7 b)

a Annual incidence per family adjusted for age, gender, and subregion. Source: Payment et al. (1991).

Tapwater (a) 1.53 2.05

Relative Risk (RR ¼ a=b)

35% 33%

Attributable Risk Exposed (AR ¼ a 7 b=a)

TABLE 7.9 Incidencea of Highly Credible Gastroenteritis Episodes, Experimental Epidemiologic Study

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EPIDEMIOLOGIC CONCEPTS

the different results observed in Canada and Australia are due to contamination levels of the source water and operation. 7.7.2

Cohort Studies

THMs and Spontaneous Abortions. A large prospective study of pregnant women conducted in California, from 1989 to 1991, revealed statistically significant associations between the spontaneous abortion rate and trihalomethane levels (Waller et al. 1998). The women were recruited from the members from a large managed healthcare organization. The subject’s address was used to determine her residential drinking water utility. The total trihalomethanes water quality reports for the period were obtained directly from the identified utilities. For 77% of the cohort, the trihalomethane levels were estimated by averaging all distribution measurements taken by the subject’s utility within the subject’s first trimester. For the remainder of the cohort who had no other data available, the annual average from the utility’s annual water quality report was used. Similar methods were used to estimate first trimester drinking water levels of individual trihalomethanes. Each woman’s daily tapwater intake at 8 weeks’ gestation was estimated from information taken during a telephone interview. The analysis controlled for the following factors that were independently related to spontaneous abortion: gestational age at interview, maternal age at interview, cigarette smoking, and history of pregnancy loss, maternal race, and employment during pregnancy. Women who drank more than five glasses per day of cold tapwater containing >75 mg=L total trihalomethanes had an adjusted odds ratio of 1.8 for spontaneous abortion (95% CI 1.1–3.0). Of the four individual trihalomethanes, only high bromodichloromethane exposure (consumption of more than five glasses per day of cold tapwater containing >18 mg=L bromodichloromethane) was associated with spontaneous abortion both alone (adjusted OR ¼ 2.0; 95% CI ¼ 1.2–3.5) and after adjustment for the other trihalomethane (adjusted OR ¼ 3.0; 95% CI ¼ 1.4–6.6). Chlorinated Water and Cancer Mortality. A cohort study conducted in Washington County, MD, in 1975 found no statistically significant associations between the incidence of cancer mortality and residence in an area where chlorinated surface water was distributed (Wilkins and Comstock 1981). The cohort was established from a private census during Summer 1963 and followed for 12 years through July 1975. The source of drinking water at home was ascertained and personal and socioeconomic data were collected for each county resident including age, education, smoking history, and number of years residing at the 1963 address. Potential cases of cancer were obtained from death certificate records, the county’s cancer registry, and medical records of the county hospital and a regional medical center. Census data were used to compute age–gender–site-specific cancer mortality rates for 27 causes of death, including 16 cancer sites, cardiovascular disease, vehicular accidents, all causes of death, and pneumonia at the end of the follow-up period in 1975. Three exposure categories were examined: a high exposure group of residents served by chlorinated surface water, a low-exposure group served by unchlorinated

7.7 EXAMPLES: EXPERIMENTAL, COHORT, AND CASE–CONTROL STUDIES

173

deep wells, and a third group served by a combination of chlorinated surface water and groundwater. The average chloroform level from an extensive analysis of chlorinated surface water samples was 107 mg=L. The third group, which likely represented an intermediate exposure, was not used in detailed analyses. In the analysis, confounding bias was controlled and incidence rates were adjusted by multiple regression analysis for age, marital status, education, smoking history, frequency of church attendance, adequacy of housing, and persons per room in the household. Selected cancer mortality rates for males and females are reported in Table 7.10. The RR for liver cancer mortality among females is 1.81 (RR ¼ 19.9=11.0). Although the study was of high quality and well conducted, the associations reported are subject to random error (i.e., all RRs had a CI that included 1.0 and thus were not statistically significant). Even though some 31,000 people were included in the cohort, estimates of the magnitude of bladder cancer risk associated with chlorinated surface water were based on only 29 deaths in females and 51 in males. History of length of residence by each person at the 1963 address was used to estimate his or her duration of exposure to chlorinated and unchlorinated water. For bladder, liver, and lung cancer in females and bladder cancer in males, the association was stronger for persons who had lived in their 1963 domicile for 12 or more years than for those who had been residents for 3 years or less. Among men who had been in their 1963 homes 12 years or more and thus had at least 24 years exposure to chlorinated surface water in 1975, the RR for bladder cancer was 6.46 (95% CI ¼ 1.00–100). Although the estimated magnitude of bladder cancer risk was ‘‘strong,’’ random error is illustrated by the large CI. The estimate ranged from RR ¼ 1.00 (no increased risk) to RR > 100, a very imprecise and statistically unstable estimate. Additional follow-up of the cohort for several more years could possibly have provided a more statistically stable association. Small numbers of

TABLE 7.10

Incidencea of Cancer Mortality in Cohort Study in Maryland Chlorinated Surface Water

Cause of Death

Deaths

Incidence Rate

Liver cancer Kidney cancer Bladder cancer

31 11 27

19.9 7.2 16.6

Liver cancer Kidney cancer Bladder cancer

9 15 46

6.4 10.6 34.6

a

Unchlorinated Groundwater Deaths Females 2 2 2 Males 2 3 5

Adjusted incidence rate per 100,000 person-years. Confidence interval. Source: Wilkins and Comstock.

b

Risk

Incidence Rate

RR

95% CIb

11.0 7.1 10.4

1.81 1.01 1.60

0.64–6.79 0.26–6.01 0.54–6.32

9.0 13.6 19.2

0.71 0.78 1.80

0.19–3.51 0.27–2.69 0.80–4.75

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cases lead to an imprecise estimate of risk; more years of observation may have yielded more cases.

7.7.3

Case–Control Studies

Water Disinfection and Bladder Cancer. In Massachusetts, a number of towns have used surface water disinfected only with either chlorine or chloramine since 1938, providing an opportunity to compare cancer risks between these two disinfectants. A previous ecological study had revealed bladder cancer mortality to be weakly associated with residence at death in Massachusetts communities using chlorine disinfection (Zierler et al. 1986). Because of likely exposure misclassification bias in this study, a case–control study was conducted to further explore the association (Zierler et al. 1988). Eligible for the study were all persons who were >44 years of age at death and who died during 1978–1984 from either bladder cancer, lung cancer, lymphoma, cardiovascular disease, cerebrovascular disease, or chronic obstructive pulmonary disease while residing in 43 selected communities. Included were 614 persons who died of primary bladder cancer and 1074 individuals who died of other causes. Confounding bias for age, gender, smoking, and occupation was controlled by multiple logistic regression. Analyses included a person’s usual exposure (at least 50% of their residence since 1938 was in a community where surface water was disinfected by only one of the two disinfectants, either chlorine or chloramine) or lifetime exposure to water disinfected with only one of the two disinfectants. The mortality OR for lifetime exposure to chlorinated surface water (OR ¼ 1.6) was higher than the OR for usual exposure (OR ¼ 1.4), and only the OR for lifetime exposure is presented in Table 7.11. After adjusting for various confounding characteristics, a 60% increased risk of bladder cancer mortality was found among lifetime residents of communities that used only chlorinated surface water compared to lifetime residents of communities that used only chloraminated surface water (OR ¼ 1.6 vs. 1.0). The association is statistically significant (i.e., the CI does not include 1.0), and the estimate of risk is precise (i.e., the CI is small). The study is of high quality; systematic bias was evaluated and not felt to be of concern. However, since the magnitude of the association is not large, confounding by unknown, unmeasured characteristics may be present, and it is difficult to interpret this association because it is the only analytical study that compares chlorinated and chloraminated water. TABLE 7.11 Case–Control Study of Bladder Cancer Mortality in Massachusetts Drinking Water Exposure Chlorinated, lifetime exposure Chloraminated, lifetime exposure a

Cases

Controls

ORa

95% CI

251 224

323 387

1.6 1.0

1.2–2.1

Adjusted for age, gender, cigarette pack–years, and residence in community with high-risk occupations. Source: Zierler et al. (1988).

7.7 EXAMPLES: EXPERIMENTAL, COHORT, AND CASE–CONTROL STUDIES

175

Arsenic and Bladder Cancer. Bates et al. (1995) evaluated bladder cancer associations in a U.S. population exposed to relatively low levels of drinking water arsenic. The case–control study of Utah respondents to the National Bladder Cancer Study in 1978 included 117 bladder cancer cases and 266 population-based controls and was conducted in areas where 92% of towns had drinking water arsenic levels less than 10 mg=L; one town had more than 50 mg=L of arsenic. Persons were interviewed, and individual exposures to arsenic in drinking water were estimated by linking residential history information with water sampling information. Two indices of cumulative arsenic exposure were used: total cumulative exposure and intake concentration. Exposures were in the range 0.5–160 mg=L arsenic (mean 5.0 mg=L). No overall increase was reported in bladder cancer risk with increasing exposure to arsenic in drinking water considering either cumulative dose or intake concentration. However, Bates et al. (1995) reported that among ‘‘cigarette smokers there was a non-significant elevation in risk that was not dose related.’’ Among smokers only, positive trends in risk were found for exposures estimated for decade-long time periods, especially in the 30–39-year period prior to diagnosis. Table 7.12 presents information about the magnitude of relative risks, none of which were statistically significant (i.e., the CI included unity), among all participants using cumulative dose of arsenic from water. In a case–control study, the odds ratio (OR) is interpreted as a relative risk; that is, the cancer risk for exposed persons is relative to risk for persons who are unexposed or have low exposure. Persons in the study that had cumulative waterborne arsenic exposures <19 mg were considered as the baseline; persons with exposures of 19–33 mg had 56% higher risks than those with exposures of less than 19 mg. However, persons with exposures of 33–53 mg had 5% less risk, and those with the highest exposure had 41% higher risks. Relative risks did not increase with increased exposure, and none were statistically significant. Kurttio et al. (1999) also considered low drinking water arsenic exposures in a more recent case–control study of bladder and kidney cancer in Finland. Individual exposures and confounding factors were considered for each case of bladder cancer, each case of kidney cancer, and each control. Study participants were selected from a register-based cohort of all Finns who had lived at an address outside the municipal

TABLE 7.12 Case–Control Study of Arsenic and Bladder Cancer in Utah Cumulative Dose of Arsenic (mg) <19 19–33 33–53 >53 a

Bladder Cancer Risk OR (95% CI)a 1 1.56 (0.8–3.2) 0.95 (0.4–2.0) 1.41 (0.7–2.9)

Risks were adjusted for gender, age, smoking, and other possible confounders. Source: Bates et al. (1995).

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EPIDEMIOLOGIC CONCEPTS

drinking water system during 1967–1980 (n ¼ 144,627). The final study population consisted of 61 bladder cancer cases and 49 kidney cancer cases diagnosed between 1981 and 1995, as well as an age- and sex-balanced random sample of 275 subjects, which were the reference cohort. Kurttio et al. (1999) assessed the levels of arsenic in drilled wells in Finland. Water samples were obtained from the wells used by the study population at least during 1967–1980. Arsenic concentrations in the wells of the reference cohort were low. The reported median concentration was 0.1 mg=L, and the maximum was 64 mg=L; 1% exceeded 10 mg=L. Arsenic exposures that were evaluated included the measured arsenic concentration in the well and the estimated daily dose and cumulative dose of arsenic. In Finland, none of the exposure indicators was statistically significantly associated with the risk of kidney cancer. Bladder cancer tended to be associated with arsenic concentration in the well and with daily dose during years 3–9 prior to the cancer diagnosis (short latency period). Considering a short latency period, the relative risk for bladder cancer for water arsenic concentrations >0.5 mg=L was more than twice the risk for concentrations <0.1 mg=L (Table 7.13). At exposures for 10 years before diagnosis (long latency period), no statistically significant increased risk was observed. Also, no statistically significant increased risks of bladder cancer were seen with cumulative water arsenic dose at either short or long latencies (Table 7.13). Since exposures earlier than 10 years before cancer diagnoses did not show an association with bladder cancer risk, the investigators suggested that relatively recent arsenic exposure might be more relevant for assessing bladder cancer risk. This is consistent with the hypothesis that arsenic may act

TABLE 7.13 in Finland

Case–Control Study of Arsenic and Bladder Cancer Bladder Cancer Risk OR (95% CI)

Exposures Water arsenic (mg=L) <0.1 0.1–0.5 >0.5–64 Daily arsenic dose (mg=day) <0.2 0.2–1.0 >1.0 Cumulative arsenic dose (mg) <0.5 0.5–2.0 >2.0 a

Exposure 3–9 years before diagnosis. Exposure  10 years. Source: Kurttio et al. (1999).

b

Short Latencya

Long Latencyb

1 1.53 (0.8–3.1) 2.44 (1.1–5.4)

1 0.81 (0.4–1.6) 1.51 (0.6–1.6)

1 1.34 (0.7–2.7) 1.84 (0.8–4.0)

1 0.76 (0.4–1.5) 1.07 (0.5–1.5)

1 1.61 (0.7–3.5) 1.50 (0.7–3.2)

1 0.81 (0.4–1.7) 0.53 (0.3–1.1)

7.7 EXAMPLES: EXPERIMENTAL, COHORT, AND CASE–CONTROL STUDIES

TABLE 7.14

177

Smoking, Arsenic in Water, and Bladder Cancer in Finland Bladder Cancer Risk OR (95% CI)

Exposure Water arsenic (mg=L) <0.1 0.1–0.5 >0.5–64

Smoker in the 1970s

Nonsmokera or Ex-smoker in the 1970s

1 1.10 (0.2–6.2) 10.3 (1.2–92.6)

1 0.95 (0.3–3.6) 0.87 (0.3–3.0)

a In this context, one who has never smoked. Source: Kurttio et al. (1999).

as a promoter or cocarcinogen in the late stage of carcinogenesis. Kurttio et al. (1999) also reported a possible synergistic effect between arsenic and smoking (Table 7.14). The association between arsenic exposure and bladder cancer tended to be stronger among persons who smoked in the 1970s. This is consistent with results of experimental studies suggesting that arsenic may promote carcinogenicity of known carcinogens. It is interesting to compare the results of case–control studies in Utah and Finland, since both evaluated latency and low arsenic exposures. Information presented in Table 7.15 shows no statistically significant increased risks of bladder cancer associated with cumulative arsenic doses ranging from <0.5 mg to >10.2 mg. These findings suggest that cumulative exposures to low levels of arsenic may not increase bladder cancer risks. However, it is possible that current levels of arsenic measured in the wells more accurately reflect short-term exposures. Cumulative long-term exposures may be less important than short-term exposures, or these exposures may be more sensitive to misclassification errors when estimating exposure. These

TABLE 7.15 Comparison of Bladder Cancer Risks Reported in Utah (Bates et al. 1995) and Finland (Kurttio et al. 1999) Bladder Cancer Risk OR (95% CI) Cumulative Arsenic Dose (mg)

Short Latency

Long Latency

Finland <0.5 0.5–2.0 >2.0 Utah <4.4 4.4–6.9 6.9–10.2  10.2

(<9 years) 1 1.61 (0.7–3.5) 1.50 (0.7–3.2) (<9 years) 1 1.18 (0.6–2.3) 0.97 (0.5–2.0) 1.11 (0.6–2.2)

(10 years and earlier) 1 0.81 (0.4–1.7) 0.53 (0.3–1.1) (40–49 years) 1 0.52 (0.2–1.8) 0.68 (0.2–2.1) 0.65 (0.2–2.4)

178

EPIDEMIOLOGIC CONCEPTS

two case–control studies have provided provocative findings, and the investigators recommended that further research should be conducted.

7.8

FUTURE TRENDS IN EPIDEMIOLOGY AND DRINKING WATER

Originally concerned with communicable disease outbreaks and epidemics, epidemiology has evolved to include the study of chronic diseases, accidents, and various other health conditions. Its evolution continues as new methods are developed to better study the small risks associated with occupational and environmental exposures (Talbott and Craun 1995). Biochemical techniques are now frequently used in serological and molecular epidemiology and can improve a study’s sensitivity to detect associations (Hulka et al. 1990). Molecular techniques in clinical specimens and environmental samples allow improved detection of pathogens. With the widespread use of improved analytical techniques to measure cellular, biochemical, or molecular alterations in human tissues, cells, or fluids, adverse effects can be studied more carefully in people who do not have overt symptoms of disease. These biological markers may also serve as indicators of exposure or dose. For example, the study of serum antibodies in populations with different water sources and water treatment may help epidemiologists determine endemic waterborne risks of cryptosporidiosis. Descriptive studies are useful to identify emerging problems, to develop specific hypotheses for study by analytical studies, and in some instances to evaluate health conditions and control programs. Experimental and analytical studies are able to provide evidence of a causal association between exposure and disease and estimates of the magnitude of risk, but the studies must be carefully designed and conducted to avoid random and systematic bias. Because small risks are usually observed in environmental studies, it is extremely important to consider the effect of misclassification bias and confounding on the interpretation of a study’s results. When considering the evidence for a specific hypothesis, it is important to critically evaluate each study to determine the amount of information it is able to contribute to the overall evaluation of an association’s causality or magnitude of risk. Few efforts have been made to systematically evaluate drinking water studies either as part of a convened group of epidemiologists or as a review of the literature. An improved systematic approach is needed for an overall evaluation of individual studies and to summarize the information in a more meaningful way than, for example, the meta analysis that attempted to assess risks that may be associated with chlorinated water. As any science, epidemiology has its own vocabulary, and to understand the results of studies, readers must become familiar with the terminology. Readers must also be able to evaluate the quality of the studies. Well-designed and -conducted studies, however, can provide evidence (or the lack thereof) of specific health effects in humans, and estimate the magnitude of risk under real-life exposures or conditions. Epidemiology has been successfully used to reduce uncertainty in risk assessments and regulatory actions and evaluate the beneficial effects of public health control measures. As epidemiologic studies become more precise,

ACKNOWLEDGMENTS

179

bias-free, and improved validity, the effects associated with drinking water contaminants will become better understood. This will also improve the risk assessments associated with those contaminants and allow regulatory agencies to develop policies and regulations with less uncertainty.

ACKNOWLEDGMENTS This chapter was expanded and updated based on the basis of a previously published article, ‘‘An introduction to epidemiology,’’ written by the same authors and published in the public domain in J. Am. Water Works Assoc. 88(9): 54–65, 1996.

REFERENCES Anonymous 1992. Editorial, Chlorinated water and cancer: is a meta-analysis a better analysis? Pediatric Alert 17:91. Aramini, J., J. Wilson, B. Allen, J. Holt, W. Sears, M. McLean, and R. Coper. 2000. Drinking Water Quality and Health Care Utilization for Gastrointestinal Illness in Greater Vancouver. Population and Public Health Branch, Guelph, Ontario: Health Canada. Bailar III, J. C. 1995. The practice of meta-analysis. J. Clin. Epidemiol. 48(1):149–157. Bates, M.N., A.H. Smith, and K. P. Cantor. 1995. Case-control study of bladder cancer and arsenic in drinking water. Am. J. Epidemiol. 141:523–530. Beaglehole, R., R. Bonita, and T. Kjellstrom. 1993. Basic Epidemiology. Geneva, Switzerland.: World Health Organization. Bennett, J. V., S. D. Holmberg, M. F. Rogers, and S. L. Soloman. 1987. Infectious and parasitic diseases. In Closing the Gap: The Burden of Unnecessary Illness. R. W. Amler and H. B. Dull, eds. Oxford, UK: Oxford Univ. Press, pp. 102–114. Calderon, R. L., and G. F. Craun. 2000. Community intervention study for estimation of endemic waterborne disease. Epidemiology 11:S123. Chappell, C. L., P. C. Okhuysen, C. R. Sterling, and H. L. DuPont. 1996. Cryptosporidium parvum: Intensity of infection and oocyst excretion patterns in healthy volunteers. J. Infect. Diseases 173:232–236. Colford, J. M., J. R. Rees, T. J. Wade, A. Khalakdina, J. F. Hilton, I. J. Ergas, S. Burns, A. Benker, C. Ma, C. Bowen, D. C. Mills, D. J. Vugia, D. D. Juranek, and D. A. Levy. 2002. Participant blinding and gastrointestinal illness in a randomized, controlled trial of an inhome drinking water intervention. Emerg. Infect. Diseases 8(1):29–36. Craun, G. F. 1990. Methods for the Investigation and Prevention of Waterborne Disease Outbreaks. EPA=600=1-90=005a. Washington, DC: USEPA. Craun, G. F. 1993. Epidemiologic studies of water disinfectants and disinfection by-products. In Safety of Water Disinfection: Balancing Chemical and Microbial Risks. G. F. Craun, ed. Washington, DC: ILSI Press, pp. 277–302. Craun, G. F. 1994. Chairman, Report of New York City’s Advisory Panel on Waterborne Disease Assessment, New York City Dept. Environmental Protection, Oct. 7.

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Craun, G. F., F. J. Frost, R. L. Calderon, E. D. Hilbvorn, K. M. Fox, D. J. Reasoner, C. L. Poole, D. J. Rexing, S. A. Hubbs, and A. P. Dufour. 2001. Improving waterborne disease outbreak investigations. Internatl. J. Environ. Health Research 11:229–243. Craun, G. F., R. M. Clark, J. Doull, W. Grabow, G. M. Marsh, D. A. Okun, M. D. Sobsey, and J. M. Symons. 1993. Conference conclusions. In Safety of Water Disinfection: Balancing Chemical and Microbial Risks. G. F. Craun, ed. Washington, DC: ILSI Press, pp. 657–668. Dann S. M., P. C. Okhuysen, B. M. Salameh, H. L. Dupont, and C. L. Chappel. 2000. Fecal antibodies to Cryptosporidium parvum in healthy volunteers. Infect. Immunol. 68:5068– 5074. Doll, R. and A. B. Hill. 1964. Mortality in relation to smoking: ten years’ observations of British doctors. Br. Med. J. i: 1399–1410. DuPont, H. L., C. L. Chappell, C. R. Sterling, P. C. Okhuysen, J. B. Rose, and W. Jakubowski. 1995. The infectivity of Cryptosporidium parvum in healthy volunteers. New Engl. J. Med. 332:855–859. Frost, F. J., A. A. de la Cruz, D. M. Moss, M. Curry, and R. L. Calderon. 1998. Comparisons of ELISA and Western blot assays for detection of Cryptosporidium antibody. Epidemiol. Infect. 121(1):205–211. Frost, F. J. and G. F. Craun. 1998. Serological response to human Cryptosporidium infection (letter). Infect. Immunol. 66(8):4008. Frost, F. J., T. Muller, G. F. Craun, D. Frasier, D. Thompson, R. Notenboom, and R. L. Calderon. 2000a. Serological analysis of a cryptosporidiosis epidemic. Internatl. J. of Epidemiol. 29:376-379. Frost, F. J., T. B. Muller, C. K. Fairley, J. S. Hurley, G. F. Craun, and R. L. Calderon. 2000b. Serological evaluation of Cryptosporidium oocyst findings in the water supply for Sydney, Australia. Internatl. J. Environ. Health Research 10:35–40. Goldstein, S. T., D. D. Juranek, O. Ravenholt, A. W. Hightower, D. G. Martin, J. L. Mesnik, S. D. Griffiths, A. J. Bryant, R. R. Reich, and B. L. Herwaldt. 1996. Cryptosporidiosis: An outbreak associated with drinking water despite state-of-the-art water treatment [published erratum appears in Annals Intl. Med. 125(2):158]. Annals Int. Med. 124(5): 459–468. Greenland, S. 1988. Variance estimation for epidemiological effect estimates under misclassification. Statist. Med. 7:745–757. Greenland, S. 1994. Invited commentary: A critical look at some popular meta-analytic methods. Am. J. Epidemiol. 140:290–296. Greenland, S. and J. Robins. 1994a. Invited commentary: Ecologic studies—biases, misconceptions, and counter examples. Am. J. Epidemiol. 139:747–760. Greenland, S. and J. Robins. 1994b. Accepting the limits of ecologic studies. Am. J. Epidemiol. 139:769–771. Grimm, L. M., M. Goldoft, J. Kobayashi, J. H. Lewis, D. Alfi, A. M. Perdichizzi, P. I. Tarr, J. E. Ongarth, S. L. Moseley, and M. Samadpour. 1995. Molecular epidemiology of a fast-food restuarant-associated outbreak of Escherichia coli O157:H7 in Washington State. J. Clin. Microbiol. 33:2155–2158. Harter, L., F. Frost, and W. Jakubowski. 1982. Giardia prevalence among 1- to 3-year old children in two Washington State Counties. Am. J. Public Health 72:386–388. Hellard, M. E., M. I. Sinclair, A. B. Forbes, and C. K. Fairley. 2001. A randomized blinded controlled trial investigating the gastrointestinal health effects of drinking water quality. Environ. Health Perspect. 109:773–778.

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Hill, A. B. 1965. Environment and disease: Association or causation? Proc. Roy. Soc. Med. 58:295–300. Hulka, B. S., T. M. Wilcosky, and J. D. Griffith. 1990. Biological Markers in Epidemiology. Oxford, UK: Oxford Univ. Press. IAMFES. 1996. Procedures to Investigate Waterborne Illness, 2nd ed. Des Moines, IA.: International Association of Milk, Food, and Environmental Sanitarians, Inc. IARC. 1991. International Agency for Research on Cancer, Chlorinated Drinking-Water: Chlorination By-products; Some Other Halogenated Compounds; Cobalt and Cobalt Compounds, Vol. 52. Geneva, Switzerland: World Health Organization. Kent, G. P., J. R. Greenspan, J. L. Herndon, M. S. Lynne, M. Mofenson, J. S. Harris, R. Thomas, and H. A. Waskin. 1988. Epidemic giardiasis caused by a contaminated public water supply. Am. J. Public Health 78:139–143. Kleinbaum, D. G., L. L. Kupper, and H. Morgenstern. 1982. Epidemiologic Research: Principles and Quantitative Methods, Belmont, CA: Lifetime Learning Publications, pp. 403–418. Kurttio, P., E. Pukkala, H. Kahelin, A. Auvinen, and J. Pekkanen. 1999. Arsenic concentrations in well water and risk of bladder and kidney cancer in Finland. Environ. Health Perspect. 107(5):705–710. Last, J. M., ed. 1995. A Dictionary of Epidemiology, 3rd ed. Oxford, UK: Oxford Univ. Press. MacKenzie, W. R., N. J. Hoxie, M. E. Proctor, M. S. Gradus, K. A. Blair, D. E. Peterson, J. J. Kazmierczak, D. G. Addiss, K. R. Fox, J. B. Rose, and J. P. David. 1994. A massive outbreak in Milwaukee of cryptosporidium infection transmitted through the public water supply [published erratum appears in New England Journal of Medicine 331(15):1035 (Oct. 13, 1994)] (see comments). New Engl. J. Med. 331(3):161–167. Moe, C. L., M. D. Sobsey, P. W. Stewart, and D. Crawford-Brown. 1999. Estimating the risk of human calicivirus infection from drinking water. International Workshop on Human Caliciviruses, Atlanta, GA: CDC. Monson, R. R. 1980. Occupational Epidemiology. Boca Raton, FL.: CRC Press. Morris, R. D., E. N. Naumova, R. Levin, and R. L. Munasinghe. 1996. Temporal variation in drinking water turbidity and disguised gastroenteritis in Milwaukee. Am. J. Public Health 86(2):237–239. Morris, R. D., A. M. Audet, I. F. Angelillo, T. C. Chalmers, F. Mosteller. 1992. Chlorination, chlorination by-products and cancer: A meta-analysis. Am. J. Public Health 82:955. Muller T. B., G. F. Craun, and R. L. Calderon. 2001. Serological responses to Cryptosporidium infection. Infect. Immunol. 69(3):1974. Neugebauer, R. and S. Ng. 1990. Differential recall as a source of bias in epidemiological research. J. Clin. Epidemiol. 43(12):1337–1341. Okhuysen P. C., C. L. Chappel, C. R. Sterling, W. Jakubowski, and H. L. DuPont. 1998. Susceptibility and serological response of healthy adults to re-infection with Cryptosporidium parvum. Infect. Immunol. 66:441–443. Oregon Health Division. 1992. A Large Outbreak of Cryptosporidiosis in Jackson County, CD Summary, Portland, OR.: Oregon Health Division. Parsonnet, J., S. C. Trock, C. A. Bopp, C. J. Wood, D. G. Addiss, F. Alai, L. Gorelkin, N. Hargett-Bean, R. A. Gunn, and R. V. Tauxe. 1989. Chronic diarrhea associated with drinking untreated water. Annals Int. Med. 110:985–991.

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Payment, P., L. Richardson, J. Siemiatycki, R. Dewar, M. Edwards, and E. Frances. 1991. A randomized trial to evaluate the risk of gastrointestinal disease due to consumption of drinking water meeting current microbiological standards. Am. J. Public Health 81:703– 707. Payment P., J. Siemiatycki, L. Richardson, G. Renaud, E. Franco, and M. Prevost. 1997. A prospective epidemiological study of gastrointestinal health effects due to the consumption of drinking water. Internatl. J. Environ. Health Research 7:5–31. Piantadosi, S. 1994. Invited commentary: Ecologic biases. Am. J. Epidemiol. 139:71–64. Poole, C. 1994. Editorial: Ecologic analysis as outlook and method. Am. J. Public Health 84: 715–716. Poole, C. 1997. Analytical Meta-Analysis of Epidemiologic Studies of Chlorinated Drinking Water and Cancer: Quantitative Review and Re-analysis of the Work Published by Morris et al., Am. J. Public Health 82:955–963. Cincinnati: National Center for Environmental Assessment, USEPA. Rockett, I. R. H. 1994. Population and Health: An Introduction to Epidemiology, Washington, DC: Population Reference Bureau. Rothman, K. J. 1996. Modern Epidemiology, Boston, MA: Little, Brown. Schwartz, J. 1995. Editorial: Is carbon monoxide a risk factor for hospital admission for heart failure? Am. J. Public Health 85: 1343–1345. Schwartz, J. and R. Levin. 1999. Drinking water turbidity and health. Epidemiology 10:86–90. Schwartz, J., R. Levin, and R. Goldstien. 2000. Drinking water turbidity and gastrointestinal illness in the elderly of Philadelphia. J. Epidemiol. Community Health 54:45–51. Schwartz, J., R. Levin, and K. Hodge. 1997. Drinking water turbidity and pediatric hospital use for gastrointestinal illness in Philadelphia. Epidemiology 8:615–620. Schwartz, S. 1994. The fallacy of the ecological fallacy: The potential misuse of a concept and the consequences. Am. J. Public Health 84: 819–823. Snow, J. 1965. Snow on Cholera. New York: Hafner. Susser, M. 1994a. The logic in ecological: I. The logic of analysis. Am. J. Public Health 84: 825–829. Susser, M. 1994b. The logic in ecological: II. The logic of design. Am. J. Public Health 84:830–835. Talbott, E. and G. F. Craun. 1995. Introduction to Environmental Epidemiology, Boca Raton, FL: CRC Press. Waller, K., S. H. Swan, G. DeLorenze, and B. Hopkins. 1998. Trihalomethanes in drinking water and spontaneous abortion. Epidemiology 9:134–140. Ward, R. L., D. I. Bernstein, E. C. Young, J. R. Sherwood, D. R. Knowlton, and G. M. Schiff. 1986. Human rotavirus studies in volunteers: Determination of infectious dose and serological response to infection. J. Infect. Diseases 154:871–880. Wilkins, J. R. and G. W. Comstock. 1981. Source of drinking water at home and site-specific cancer incidence in Washington County, Maryland. Am. J. Epidemiol. 114:178. Zierler, S., R. A. Danley, and L. Feingold. 1986. Type of disinfectant in drinking water and patterns of mortality in Massachusetts. Environ. Health Perspect. 69:275. Zierler, S., L. Feingold, R. A. Danley, and G. Craun. 1988. Bladder cancer in Massachusetts related to chlorinated and chloraminated drinking water: A case–control study. Arch. Environ. Health 43:195–199.

8 APPLICATION OF RISK ASSESSMENTS IN CRAFTING DRINKING WATER REGULATIONS BRUCE A. MACLER, Ph.D. Toxicologist, U.S. Environmental Protection Agency, San Francisco, California

8.1

INTRODUCTION

Assessments of adverse health outcomes and estimations of health risks from contaminants of drinking water are used at several points in the overall development of U.S. drinking water regulations. They are applied during the extensive discussions surrounding consideration of a contaminant’s risk and approaches to risk mitigation, and in the required elements of National Primary Drinking Water Regulation (NPDWR) proposals, support documents, and final rules. Risk assessments are of several types with substantially different intents and characteristics. No one approach fits all applications. The type of assessment chosen depends on the application and the nature and availability of relevant data. The regulatory process starts with the identification of a constituent as either a possible contaminant of drinking water or as having some adverse toxicological or pathogenic properties. Available health data are then collected and analyzed, leading to the possible development of a toxicological profile of adverse health outcomes and dose–response characteristics. This is then coupled with occurrence data and Disclaimer : The views expressed in this chapter are those of the author and do not necessarily represent those of the USEPA. Drinking Water Regulation and Health, Edited by Frederick W. Pontius. ISBN 0-471-41554-5 # 2003 John Wiley & Sons, Inc.

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exposure estimates to provide an estimate of national public health impact. If a decision is made to move forward on a NPDWR, more refined assessments are then used to develop maximum contaminant level goals (MCLGs). Separate assessments are used to help identify possible maximum contaminant levels (MCLs) or treatment techniques consistent with public policies. In some cases, risk assessments may comprise regulatory elements themselves, such as sanitary surveys or comprehensive performance evaluations. Finally, risk assessments are necessary as formal components of regulatory supporting documents to help estimate risk reductions and quantify public health benefits. Some of these assessments, particularly those associated with public health policies and legal requirements, are highly constrained in form and content. Additionally, while the art and science of environmental risk assessment continue to evolve, we still have substantial uncertainty and imprecision in these estimates. Effective interpretation of these risk products requires some understanding of their purpose and form. This chapter details these applications and presents some examples.

8.2 RISK ASSESSMENT APPROACHES FOR DRINKING WATER REGULATIONS In risk management activities to ensure the safety of drinking water, assessments of health risk are performed to answer questions posed in the management process (Fig. 8.1). Examples include broad questions such as ‘‘What is the nature and magnitude of waterborne disease in the United States?’’—answers to which can help define where the safety of drinking water fits into the overall considerations of public health, or identify particular situations (e.g., undisinfected wells, crossconnections) that are associated with disease. More familiarly, risk assessments can address narrower questions such as ‘‘What is the risk that oral ingestion of hexavalent chromium will cause lung cancer?’’ or ‘‘What is the likelihood of Cryptosporidium illnesses from a turbidity spike in an unfiltered surface water system?’’ where the answers might help define regulatory actions. Specific questions, such as ‘‘What is the likely differential number of cancers prevented between a MCL for arsenic at 3 mg=L and one at 5 mg=L?’’ or ‘‘What are failure modes in the operation of an upflow clarifier?’’ may need to be answered to compare or determine possible solutions to the identified problems. Risk assessment approaches for drinking water health and regulatory questions fall into three main types: those based on epidemiologic data, those calculated using mathematical risk models, and those based on analysis of systems and components. Epidemiologic and risk model approaches have been described more completely in earlier chapters, so only their applicability to regulatory development is addressed here. For this purpose, it is important to remember that there are substantial and important limitations to these approaches and that the conclusions from such assessments must be considered with due caution by those using the information. In addition, management decisions are often required in the face of uncertainty and

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Figure 8.1 Integration of data collection, risk assessment, and risk management [source: Farland (2000)].

lack of information. Risk assessments can provide useful information, but seldom give clear, unambiguous answers. With respect to epidemiologic data, information from waterborne disease outbreaks, intervention studies, or controlled experiments on humans can be used directly to both quantitatively and qualitatively describe risks. However, the precision and accuracy of epidemiologic data typically limit these assessments to situations where excess risks (risks above background levels) are about 1% or greater. More often, epidemiologic studies of large groups or populations can describe only effects greater than 10–100% or more. In general, causal associations between contaminants and effects are considered significant only when effects are severalfold higher than background levels. Therefore, risk assessments done directly from these data can generally describe risks and answer risk questions only to this level of resolution. Because public health questions for drinking water often involve situations where risks are substantially below epidemiologic resolution, this approach is frequently inappropriate. Perhaps the most familiar form of risk assessment is based on mathematical models used to extrapolate existing data to make quantitative estimates relevant to other situations. This well-known approach, first described by the National Academy of Sciences (NAS) in 1983 (NRC 1983), organizes the process of human health

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Figure 8.2 NAS risk assessment paradigm (left circle) and risk management (right circle) [source: USEPA 1999c)].

risk assessment into four steps: hazard identification, dose–response assessment, exposure assessment, and risk characterization (Fig. 8.2). Hazard identification involves an evaluation of whether exposure to a substance would produce an adverse or otherwise undesirable effect. The data used to make such a determination usually come from animal studies. In some instances, human data may be available for the contaminant of interest. Dose–response assessment involves a more quantitative evaluation of the empirical evidence relating a specific exposure dose to the effect of interest. In particular, the available data are examined to determine the relationship between the magnitude of the exposure and the probability of the observed effect. Exposure assessments involve an evaluation of contaminant occurrence data, characterization of the environmental fate and transport of the contaminant from the source to the exposed population by different media (e.g., air, water, food), and physiological considerations of different exposure routes (e.g., ingestion, inhalation, dermal contact). These toxicity and exposure products are combined in the risk characterization. The risk characterization describes the overall nature and magnitude of risk posed to human populations exposed to a particular contaminant. Included in the description is a discussion of what is known and not known about the hazards posed by the substance, what models were used to quantify the risk and why they were selected, assumptions and uncertainties associated with the qualitative and quantitative aspects of the assessment, and general level of confidence in the assessment. A caution with these is that, while the calculated results are often presented as point value expressions of risk, it must be recognized that the farther the extrapolation from the original data, the more uncertainty and less precision in the results. The animal data themselves result from what are essentially small, highly controlled epidemiologic studies, and thus have the resolution limitations noted above. In addition, experimental variation may be 10% or greater. Because these studies are

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most often conducted with high exposures to the contaminants of interest and generate high risks, models are used to extrapolate the data to answer questions about lower environmental exposures and=or risks. These models have inherent limitations that magnify uncertainties. Exposure estimates likewise have substantial variation and uncertainty. The net result is that quantitative estimates of risk cannot describe a defined point risk for a certain exposure, but instead a range of possible risks. These ranges tend to increase with increasing model complexity to frequently span orders of magnitude. Most often, the range includes zero. A third approach to risk assessment is based on analysis of an entire system or operation to identify vulnerabilities that could allow contaminants to reach the consumer. It is based on standard engineering design assessment approaches used to identify failure modes, judge probabilities of occurrence, and describe consequences. These have been adapted to focus on vulnerabilities in systems or operations that could result in human exposure to contaminants. This approach begins with a full description of the system or flow diagram of the process. Points where contamination can occur are identified. The likelihood and consequences of contamination at these points are described. From such an assessment, management actions can focus on controlling high-impact situations (Fig. 8.3). In the food

Figure 8.3 Hazard assessment critical control point (HACCP) risk assessment approach.

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industry, hazard assessment critical control point (HACCP) programs have been put into place to protect the public from, among other things, contaminated shellfish and other food items. Sanitary surveys, source water vulnerability assessments, and comprehensive performance evaluations (CPEs) are examples of this type seen in the drinking water industry. This is also the approach used for water system security and counterterrorism assessments. As currently practiced, these are qualitative, rather than quantitative in nature. Once the system is described and vulnerabilities identified, probabilities and consequences are typically rated on the basis of best professional judgment and using categories such as ‘‘high, medium, or low’’ or ‘‘minor, significant, or catastrophic.’’ The end result may be a list of vulnerabilities with some rankings for risks and consequences. Managers can use this information to identify problem areas and prioritize activities. Although not commonly practiced, it should be noted that such system analysis approaches are open to quantification of risks (Buchanan and Whiting 1998).

8.3

RISK MANDATES FROM THE SAFE DRINKING WATER ACT

The Safe Drinking Water Act (SDWA), as amended in 1986 and 1996 [Title XIV, Sec. 1412(b)] has language that directs the U.S. Environmental Protection Agency (USEPA) to establish MCLGs for contaminants of public health concern for drinking water: ‘‘Each maximum contaminant level goal established under this subsection shall be set at the level at which no known or anticipated adverse effects on the health of persons occur and which allows an adequate margin of safety.’’ These goals, which are not enforceable themselves, are to be used to set the enforceable NPDWRs [Title XIV, Sec. 1412(b)]: Each national primary drinking water regulation for a contaminant for which a maximum contaminant level goal is established under this subsection shall specify a maximum contaminant level for such contaminant which is as close to the maximum contaminant level goal as is feasible . . . . For the purposes of this subsection, the term ‘‘feasible’’ means feasible with the use of the best technology, treatment techniques and other means which the Administrator finds, after examination for efficacy under field conditions and not solely under laboratory conditions, are available (taking cost into consideration).

In addition, a provision added to the Act in 1996 specifies priorities for selecting contaminants for rulemaking to take into consideration, among other factors of public health concern, the effect of such contaminants upon subgroups that comprise a meaningful portion of the general population (such as infants, children, pregnant women, the elderly, individuals with a history of serious illness, or other subpopulations) that are identifiable as being a greater risk of adverse health effects due to exposure to contaminants in drinking water than the general population.

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In addition, the Act specifies that USEPA shall document health risks, opportunities for risk reductions, and benefits and costs of mandating these reductions and make these available for public comment. This health risk reduction and cost analysis (HRRCA) is a required component of the regulatory process. By this and other language, Congress described both the necessary characteristics of risk assessments for drinking water regulations and the broad principles for managing these risks. It can be seen that by their words, Congress established a precautionary policy with regard to drinking water safety. The MCLG was to be set conservatively with respect to risk to more vulnerable individuals. The MCL was to be set to reflect the MCLG, with the additional considerations for technical feasibilities and costs. These broadly stated goals set directions, but were not sufficiently described to be used for specific regulatory decisions. USEPA evolved operational interpretations of Congressional intentions for both the MCLG and for the acceptable public health risks associated with MCLs and treatment techniques following the 1986 amendments. These have been used consistently for NPDWRs from that time. Following the 1996 amendments, USEPA developed additional approaches for the benefit and cost analyses for the HRRCA.

8.4

DEVELOPING MCLS AND TREATMENT TECHNIQUES

The SDWA grants the USEPA Administrator the authority to publish a MCLG and promulgate a NPDWR for a contaminant if the contaminant may have an adverse effect on the health of persons, the contaminant is known or likely to occur in drinking water with a frequency or level of health concern, and there is a meaningful opportunity for health risk reduction. Development of a NPDWR normally begins with the identification of a drinking water contaminant. As provided in the SDWA, USEPA must list candidate contaminants for regulation on a periodic basis (USEPA 1998a). Following listing, more detailed health, occurrence, exposure, and treatment technology information is gathered. When adequate information becomes available, a determination is made on whether to go forward with development of a NPDWR proposal (USEPA 2002a). This determination uses a protocol developed and recommended to USEPA by the National Drinking Water Advisory Council (NDWAC). The health risk information is combined with occurrence data (levels, frequency, national distribution, persistence, etc.) and exposure estimates to predict the national number of individuals exposed above advisory levels. This risk assessment forms the basis for USEPA’s determination if regulation would provide a meaningful opportunity for health risk reduction. 8.4.1

Maximum Contaminant Level Goals

Once the decision is made to move forward, the MCLG is determined. MCLGs are risk assessment products developed by USEPA Office of Water and Office

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of Research and Development. MCLGs are strictly health-based levels. They are developed and set at contaminant levels believed to be without appreciable health risk to individuals, to be consistent with the provision ‘‘set at the level at which no known or anticipated adverse effects on the health of persons occur.’’ Additionally, they must address the concern for the protection of sensitive subpopulations. Therefore, risk assessments used to develop MCLGs must at a minimum provide an estimate for a zero-risk exposure level for humans who may be more sensitive to the contaminant. While these risk assessments are caveated to be upper bounds for estimated risks, such that the true risks may be less or even zero, the assessments do not have to, nor are they designed to, estimate the full range of true risks to the average individual. MCLG risk assessments use the available toxicologic and epidemiologic health study data. The data are evaluated with respect to the nature of the adverse health effects from the contaminant, the strength of evidence for causal relationships, and their quality. Depending on the outcome, a dose–response estimate is made. As noted above, these data are almost always limited in quantity and quality, yielding substantial ranges for uncertainty. USEPA has chosen as a matter of policy to work to risks at the more conservative end of these ranges, in order to comply with the provision that the MCLG ‘‘allows an adequate margin of safety’’ in the face of these uncertainties. Therefore, poorer-quality data will lead to more stringent quantitative descriptions of risk. For chemicals that produce adverse health effects and are not considered to be carcinogenic (noncarcinogens), the MCLG is based on the reference dose (RfD), which is defined as an estimate (with uncertainty spanning perhaps an order of magnitude) of a daily exposure to the human population (including sensitive subgroups) that is likely to be without an appreciable risk of deleterious effects during a lifetime. In practice, the RfD is set at a plausible zero-risk level. USEPA assumes that a physiological threshold exists for noncancer health effects from chemical contaminants, below which the effect will not occur. Thus the MCLG will be a nonzero number. Depending on the quality of the available toxicity data, the RfD is usually derived from an experimental no-observed-adverse-effect level (NOAEL), identified as the highest dose in the most relevant study that did not result in a known adverse effect. The adverse effects chosen may themselves be mild and without clinical significance, but typically represent early stages in progression to more serious disease. In order to extrapolate from the data to human exposures protective of sensitive subpopulations, the NOAEL is divided by various uncertainty factors to derive the RfD. These uncertainty factors conservatively account for the variation in human response to the contaminant, extrapolation to human responses if animal data were used, the nature of the studies, data quality, and relevance. The result of this is that the RfD may differ from the NOAEL by as little as a factor of 3 (e.g., nitrate, arsenic) or as much as 1000 (e.g., methyl bromide, chlorobenzene). The RfD takes the form of dose ingested per unit body weight per day (mg kg 1 day 1). RfDs that have been reviewed and agreed on by consensus within USEPA are listed in USEPA’s Integrated Risk Information System (IRIS).

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The RfD, which is based on the total daily amount of contaminant taken up by a person on a body weight basis, is converted to a drinking water equivalent level (DWEL) concentration and adjusted for the percentage contribution of other sources [relative source contribution (RSC)] of the contaminant besides drinking water (air, food, etc.) to arrive at the MCLG. This calculation traditionally assumes a lifetime consumption of 2 L of drinking water per day by a 70-kg adult, which is about the upper 90th percentile consumption level. More recent USEPA regulatory risk assessments, such as those for arsenic, have considered different drinking water consumption rates in addition to this default value to represent specific populations (infants, agricultural workers) and situations (USEPA 2001a). A different approach is taken for contaminants that may be carcinogenic. USEPA assumes as a default position that no toxicity threshold exists for induction of cancer and thus, there is no absolutely safe level of exposure. Until relatively recently, once it was determined that a contaminant is a known or probable human carcinogen, the MCLG was automatically set at zero. USEPA has now revised its guidelines for cancer risk assessments to reflect the increasing understanding of the several steps in the progression of cancer (USEPA 1999b, 2001b). Some contaminants have been reevaluated for their carcinogenicity using the current draft version of these guidelines. A good example is chloroform (USEPA 1998a), which is now considered a carcinogen only at very high exposures associated with tissue damage, such that a threshold is indicated. This allows calculation of a nonzero MCLG using a margin of exposure (MoE) approach. As with RfDs, these determinations of carcinogenicity and their associated dose–response assessments that have been reviewed and agreed on by consensus within USEPA are listed in IRIS. An alternative approach is used for situations where the data on carcinogenicity of a contaminant are equivocal or too scanty to make a clear judgment. These contaminants are termed ‘‘possible human carcinogens.’’ For these, the MCLG may be derived from their relevant noncancer health effects as described above. The resulting RfD is divided by an additional uncertainty factor of 10 as a margin of safety for the possible carcinogenicity. In a vein similar to that for carcinogens, microbial pathogens and indicator organisms are also assigned a MCLG of zero as a matter of policy, from the consideration that one infective unit (oocyst, cyst, virus particle, bacterium) could be sufficient to cause an infection. The available data on infectivity are supportive for this assumption for the pathogenic viruses studied and for the protozoa, Giardia and Cryptosporidium. While it is less clear that this is so for pathogenic bacteria, the data cannot exclude this possibility. 8.4.2

Identifying Candidate MCLs

Once the MCLG is established, it is combined with information on contaminant occurrence, treatment technologies, and analytical methods to suggest and evaluate possible regulatory criteria for further discussion. Although the MCLG is a regulatory value, it is not enforceable; the NPDWR is the enforceable regulatory element.

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One element in the standard setting process is to determine whether the NPDWR should be a MCL or a treatment technique. An enforceable MCL can be established to control exposure to a contaminant when appropriate analytical methods exist to quantify the contaminant and determine compliance at the MCL. When methods are not available, as for certain microbial exposure situations, treatment techniques may be established that do not directly measure exposure, but use other indicators for compliance. Two risk considerations come into play in the process of setting a MCL to reduce a contaminant as close as feasible to the MCLG. The first has to do with MCLGs of zero. It is impossible to quantify a contaminant or confirm treatment to a zero exposure. Therefore, MCLs must be above zero, and thus have some risk. A risk benchmark is used to identify appropriate safe drinking water exposures. These guide selection of analytical techniques, treatment approaches, and, ultimately, the MCL choices. This benchmark is based on a consideration of de minimus or ‘‘acceptable’’ risk. As a matter of policy, USEPA Office of Water has used an acceptable risk range for chemical carcinogens from one additional cancer per million people to one additional cancer per 10,000 people exposed to the contaminant over a lifetime (USEPA 1998d, 2001a). For pathogenic microorganisms, an acceptable risk of one additional infection per 10,000 people exposed per year has been used (USEPA 1989a, 1998c). These allowable exposures are estimated from the associated dose–response curves. For carcinogens, this dose–response assessment uses models to extrapolate from the available data to zero exposure–zero risk, defining a curve that is essentially linear at low exposures. The resulting ‘‘cancer slope factor’’ allows for a convenient probability analysis of risks to individuals associated with different exposures. The exposures for the acceptable risk range are taken directly from the curve. However, as noted above, the uncertainties increase substantially in these extrapolations. USEPA traditionally uses the 90th percentile upper bound of the modeled results to minimize the possibility that risks in this exposure range are not greater than estimated. The end result of this is that the risk from a lifetime consumption of water at a given level is unlikely to be greater than estimated, is more likely substantially less, and may be zero. A similar probabilistic risk approach is used for microbial contaminants. The dose–response models used for microbial risk assessments are somewhat more complex in that they must be selected to account for the particulate nature of the infective material in the environment. The modeled exposures are then used for further risk management. For contaminants with noncancer health risks, the MCLG is used as the starting point for determining a MCL. Because this uses a ‘‘bright line’’ reference point (the DWEL), exposures need only be estimated and compared to the MCLG. However, since this is nonprobabilistic, alternative MCLs cannot be considered on the basis of risks. For most noncarcinogens, the MCL is set equal to the MCLG. The estimated risks associated with different exposures are then matched against the existing environmental exposure levels to determine the magnitude of the public health problem to be solved. As discussed in other chapters, the additional con-

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siderations for treatment technologies and their feasibility and the availability of appropriate analytical methods are factored in at this point. 8.4.3

Health Risk Reduction and Cost Analysis

The second application of risk assessment in the development of a MCL or treatment technique is in the estimation of public health benefits to be gained by regulation. This is used in the management discussions leading up to a regulatory proposal. Under the SDWA of 1986, it was necessary to consider only analytical and treatment feasibility in establishing the MCL. However, a cost benefit assessment was produced as an element of the regulatory impact analysis (RIA). The 1996 revisions to the SDWA required USEPA to explicitly consider costs and benefits in determining the MCL. Therefore, an expanded HRRCA is now required as part of a regulatory proposal. To estimate benefits for different MCLs or treatment requirements, the risks to an individual at the resulting exposure levels must be multiplied by estimates of the number of individuals in the United States exposed to the different levels. In practice, a relationship between the number of individuals exposed versus exposure level is first produced, then further manipulated to account for existing and proposed treatment controls. This relationship may be calculated stepwise or by using Monte Carlo simulations based on exposure distributions. From this, the number of cancers or microbial illnesses avoided at a given regulatory level can be estimated. These ‘‘body counts’’ can be matched with information on the costs of treating the associated diseased and the dollar value of avoiding illness to give quantitative information on the monetary benefits of the regulation. These benefits are then matched against the implementation and compliance costs to utilities and oversight agencies (USEPA 1999a). From a risk assessment perspective, it must be remembered that carcinogen dose–response curves represent upper-bound risks; thus estimates of the number of cancers based on these curves are also upperbound values for any given exposure level. This approach is most useful for benefits from reducing cancer or microbial illness risks. This is both because these disease endpoints are recognizable and definitive and because the impacts are quantifiable from their probabilities. This is not so for noncancer risks from chemicals. Because these are described by nonprobabilistic, zero-risk DWELs associated with subclinical health effects of indeterminate public health importance, it is difficult to quantify or assign monetary value to the benefits of reducing exposures to these chemicals. 8.4.4

Risk Assessments as Regulations

Risk assessments can comprise regulatory elements themselves. These may apply directly to utilities or secondarily through requirements on primacy agencies. The type of risk assessments currently required in NPDWRs are all qualitative system analyses. These include treatment system sanitary surveys found in the Total Coliform Rule (USEPA 1989b) and Interim Enhanced Surface Water Treatment Rule (IESWTR) (USEPA 1998b), the watershed sanitary surveys in the Surface

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TABLE 8.1 Australian Framework for Management of Drinking Water Quality First element Commitment to drinking water quality management System analysis and management Assessment of the drinking water supply system Planning preventive strategies for water quality management Implementation of operational procedures and process control Verification of drinking water quality Incident and emergency response Supporting requirements Employee awareness and training Community involvement and awareness Research and development Documentation and reporting Review Evaluation and audit Review and continual improvement

Water Treatment Rule (SWTR) (USEPA 1989a), and the CPEs, also in the IESWTR. These all require on-site evaluations to determine sources of contamination and vulnerabilities to failures that could compromise water quality. These analyses are similar to the HACCP process used by the National Aeronautics and Space Administration (NASA) and U.S. Department of Agriculture (USDA) to protect foods. Australia has taken a more formal HACCP approach to protect their drinking water. Termed the ‘‘framework for management of drinking water quality,’’ it is to be incorporated into the Australian Drinking Water Guidelines (Australian Department of Health and Ageing 2001). The approach includes a systematic and comprehensive analysis of the entire route of water from source to tap (Table 8.1). This analysis leads to identification of hazards, sources of hazards, and associated risks. These are addressed in the subsequent institution of protective measures to yield multiple barriers to contamination. The emphasis of the HACCP approach is on proactive protection, rather than reactive responses. 8.4.5

Regulatory Reviews of NPDWRs

The 1996 SDWA Amendments required that USEPA review all existing NPDWRs every 6 years to determine if information available subsequent to promulgation would support regulatory revision. Congress stipulated that all such revisions must maintain, or provide for greater, protection of the health of persons. USEPA, working with the NDWAC, developed a protocol for these reviews, driven largely by reevaluations of health risk information (USEPA 2002a). USEPA principally considered whether any new evaluation of oral ingestion risks could lead to revision

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of the MCLG. This approach allows the Agency to use up-to-date risk assessment approaches in its reevaluations, which will include a wider range of possible adverse health outcomes (reproductive and developmental) and better characterizations of carcinogenicity. The potential here is that some carcinogens would be reclassified in such a way that their MCLs could be relaxed while maintaining the same level of health protection to the public. The reclassification of chloroform as a threshold carcinogen is an example. This would recognize that improved risk assessments could reduce the scientific uncertainties that led to excessively stringent NPDWRs.

8.5

FUTURE OUTLOOK

Risk assessments are used both formally and informally at several points within the regulatory process. They serve specific purposes and mandates and may have severe constraints on their representations of risk. While assessments may be qualitative or quantitative in nature, they are always limited by the available information and our current abilities to understand disease processes and predict outcomes. They will always be inexact. Recognizing and accepting their limitations is important for making sound regulatory decisions. An increased awareness of how risk assessments may be used will improve future regulatory discussions.

ACKNOWLEDGMENTS The author wishes to acknowledge the patient help of Fred Pontius, without which this chapter would have been the poorer.

REFERENCES Australian Department of Health and Ageing. 2001. Framework for Management of Drinking Water Quality: A Preventative Strategy from Catchment to Consumer. Canberra, Australia: National Health and Medical Research Council. Buchanan, R.L. and Whiting, R.C. 1998. Risk Assessment: A means for linking HACCP plans and public health. J. Food Protect. 61:11:1531–1534. Farland, W. H. 2000. Current and Proposed Approaches to Assessing Children’s Cancer Risk. USEPA=National Institute of Environmental Health Sciences Workshop: Information Needs to Address Children’s Cancer Risk. March 30 and 31. Washington, DC: USEPA Office of Research and Development. National Academy of Sciences. 1983. Risk Assessment in the Federal Government: Managing the Process. National Academy Press, Washington, DC. Title XIV—Safety of Public Water Systems; Sec. 1412(b), National Drinking Water Regulations: Standards; 42 USC Sec. 300g.

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USEPA. 1986. The Risk Assessment Guidelines of 1986. EPA=600=8-87=045. Washington, DC: USEPA. USEPA. 1989a. Drinking Water; National Primary Drinking Water Regulations; Filtration, Disinfection; Turbidity, Giardia lamblia, Viruses, Legionella, and Heterotrophic Bacteria; Final Rule. Fed. Reg. 54:27486–27541. USEPA. 1989b. Drinking Water; National Primary Drinking Water Regulations; Total Coliforms (including fecal coliforms and E. coli); Final Rule. Fed. Reg. 54:27544–27568. USEPA. 1998a. Announcement of the Drinking Water Candidate List; Notice. Fed. Reg. 63:10273–10287. USEPA. 1998b. National Primary Drinking Water Regulations: Disinfectants and Disinfection Byproducts Notice of Data Availability; Proposed Rule. Fed. Reg. 63:15606–15692. USEPA. 1998c. National Primary Drinking Water Regulations: Interim Enhanced Surface Water Treatment; Final Rule. Fed. Reg. 63:69478–69521. USEPA. 1998d. National Primary Drinking Water Regulations: Disinfectants and Disinfection Byproducts; Final Rule. Fed. Reg. 63:69390–69476. USEPA. 1999a. Health Risk Reduction and Cost Analysis for Radon in Drinking Water: Notice. Fed. Reg., 64:9560–9599. USEPA. 1999b. Draft Guidelines for Carcinogen Risk Assessment. NCEA-F-0644. Washington, DC: USEPA. USEPA. 1999c. Research and Development: Fiscal Years 1997–1998 Research Accomplishments. Washington, DC: USEPA Office of Research and Development. USEPA. 2001a. National Primary Drinking Water Regulations; Arsenic and Clarifications to Compliance and New Source Contaminants Monitoring; Final Rule. Fed. Reg. 66:6976–7066. USEPA. 2001b. Notice of Opportunity to Provide Additional Information and Comment. Draft Revised Guidelines for Carcinogen Risk Assessment. Fed. Reg. 66:59593–59594. USEPA. 2002a. National Primary Drinking Water Regulations; Announcement of the Results of EPA’s Review of Existing Drinking Water Standards and Request for Public Comment. Fed. Reg. 67:19029–19090. USEPA. 2002b. Announcement of Preliminary Regulatory Determination of Priority Contaminants on the Drinking Water Contaminant Candidate List. Fed. Reg. 67: 38222–38244.

9 ‘‘SOUND’’ SCIENCE AND DRINKING WATER REGULATION FREDERICK W. PONTIUS, P.E. Pontius Water Consultants, Inc., Lakewood, Colorado

9.1

INTRODUCTION

Since the earliest days of public water supply, science and scientific advances have formed the foundation regulatory agencies use to define safe drinking water. More recently, the adequacy or ‘‘soundness’’ of scientific and technical studies for regulatory decisionmaking and policy has received increasing attention. During the regulatory process, stakeholders frequently call into question the adequacy of the science that underlie proposed U.S. Environmental Protection Agency (USEPA) regulations and regulatory policy decisions. Traditionally, science has been granted a special status within developed Western society. In 1938, Albert Einstein protested plans to require Italy’s intelligentsia to pledge loyalty to the fascist regime. He wrote (Einstein 1990) the pursuit of scientific truth, detached from the practical interests of everyday life, ought to be treated as sacred by every Government, and it is in the highest interests of all that honest servants of truth should be left in peace.

But far from ‘‘being left in peace,’’ science and scientists are often engulfed in the controversy that can surround a regulatory decision or agency rulemaking, as stakeholders contend with an agency and with each other over whether a particular study represents ‘‘sound’’ science. Indeed, even defining what science is has been Drinking Water Regulation and Health, Edited by Frederick W. Pontius. ISBN 0-471-41554-5 # 2003 John Wiley & Sons, Inc.

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difficult as there is no universally applicable definition that could be applied to all fields of inquiry (Lastrucci 1963). Laypeople, scholars, and scientists themselves define the term in varying ways and employ it in a variety of contexts. Indeed, defining what science is not is more easily done than defining what science is (Taylor 1996). Nevertheless, the attributes of ‘‘sound’’ science begin to emerge as past definitions various writers have put forth for science itself are considered. Pickering (1992) construes science simply as ‘‘a way of being in, getting on with, making sense of, and finding out about the world.’’ Ackoff et al. (1962) states that Science may be considered a process of inquiry; that is, as a procedure for answering questions, solving problems, and developing more effective procedures for answering questions and solving problems. Science is also frequently taken to mean a body of knowledge.

Lastrucci (1963) proposes that ‘‘Science may be defined quite accurately and functionally as: an objective, logical, and systematic method of analysis of phenomena, devised to permit the accumulation of reliable knowledge.’’ More recently, Shermer (1997) defined science as ‘‘a set of methods designed to describe and interpret observed or inferred phenomena, past or present, and aimed at building a testable body of knowledge open to rejection or confirmation.’’ Today, the content of science is often confused with the methods of science. Much of the content of science is changing. What may be scientific (i.e., accepted as true, or ‘‘sound’’) today may become unscientific (i.e., regarded as untrue, or ‘‘unsound’’) in the future. In addition, the demarcation between science and nonscience is not always clear. In practice, it is not a clearly visible line but an area that is both shifting and subject to debate—depending on the authorities one accepts. With this backdrop, ‘‘sound’’ science might be defined as reliable knowledge obtained and accumulated by objective, logical, and accepted systematic methods of analysis appropriate for the phenomena, subject, or field of study. But even with such a simple definition, agreement regarding ‘‘soundness’’ of the science behind a specific study, regulation, or regulatory policy may still be elusive. The purpose of this chapter is to examine the dynamics behind these disagreements and discuss principles to guide discussion of scientific issues within the context of the Safe Drinking Water Act (SDWA).

9.2

ELEMENTS OF ‘‘SOUND’’ SCIENCE

‘‘Sound’’ science in drinking water regulation is no different from good science in general. For each field of scientific inquiry, textbooks and professional reference books are usually available addressing topics such as experimental design, procedures, data analysis, research methodologies, and other elements necessary for a study to be considered ‘‘sound’’ within that field. In practice, however, no study is perfect and techniques used in every study could be improved on. Clearly, a study that failed to meet minimal criteria for a key element—say, for example, too few subjects with a given exposure level, or some obvious fatal flaw in experimental design— would not be considered ‘‘sound.’’ But even when no fatal flaw is evident, disagree-

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ments regarding the soundness of a study may stem from issues regarding lack of objectivity, poor reasoning, ambiguity, and=or an absence of fair-mindedness. 9.2.1

Objectivity

Objectivity in science refers to attitudes devoid of personal whim, bias, or prejudice. It focuses on methods for ascertaining publicly demonstrable qualities of the phenomenon or subject being studied (Lastrucci 1963). Evidence in science is to be factual, not conjectural, although at times a scientist must make attempts to extend understanding beyond known facts by proposing theories, offering opinions, and making educated guesses. Even so, demonstration of evidential proof is needed to achieve acceptable scientific truth. Science is a subjective enterprise insofar as it is practiced by imperfect people. In reality, much of research is trial and error, depending on factors other than scientific laws and method (Kneller 1978). The scientist usually does not spend much time thinking about scientific laws or principles. Other things such as trying to get an experimental apparatus to work, finding a way of measuring something more accurately, or keeping a treatment system operating, occupy the time. At times a scientist may hardly know what he or she is trying to prove. By its very nature, research is typically a continual feeling out into the dark. German physicist Max Planck (1932) once observed: Anybody who has been seriously engaged in scientific work of any kind realizes that over the entrance to the gates of the temple of science are written the words: Ye must have faith. It is a quality which the scientist cannot dispense with.

When pressed to say what is being done, a scientist may present a picture of uncertainty or doubt, or even confusion. But the scientific method (discussed below) encourages a rigorous, impersonal mode of procedure dictated by the demands of logic and objective procedures. Indeed, authority in science is achieved by the accumulation of publicly ascertainable evidence supporting an argument. It should not be a consequence of mere opinion (no matter how strongly felt), not faith alone (although an element of faith may be involved), nor of mere assumed verity (which would make it a presupposition). The ideal of objectivity, in effect, recognizes that ‘‘sound’’ science must be publicly verified according to the consensus of suitably trained observers. Should a study have a bias or limitation unknown to the scientist, it will likely be uncovered by objective peer observers. 9.2.2

Reason and Truth Claims

Scientific reasoning may take several forms. Two of the most common are deductive and inductive, discussed below. Kneller (1978) identified the following forms of scientific reasoning:  Retroduction—a scientist encounters an anomaly and then seeks a hypothesis from which the existence of the anomally can be deduced. She reasons backward from the anomally to a hypothesis that will explain it.

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 Hypotheticodeduction—rather than reason to a hypothesis from data, the scientist begins with a hypothesis and deduces conclusions, general statements, or particular predictions from it.  Inductive reasoning—used to infer a general regularity from statements of particular instances.  Analogical reasoning—employed when the scientist arrives at a hypothesis by seeing an analogy between apparently unrelated phenomena. The pursuit of sound science is ultimately a quest for truth within a scientific context. Zeno (ca. 475 B.C.) made one of the earliest attempts to define truth, by reducing alternative positions to the absurd, known as the reductio ad absurdum argument. No position or statement that generates contradictions can be considered true. This law of noncontradiction is one of the fundamental principles of logical thought. At best, however, it is a negative test for truth, demonstrating that some positions are false, but failing to determine which ones are true. Deductive Reasoning Aristotle (384–322 B.C.) was the first Western philosopher to elaborate rules for deductive reasoning, although he also accepted inductive reasoning, discussed below. Deductive reasoning is simply arguing from the general to the particular, using formal rules of logic. For example, consider the premise ‘‘drinking water meeting USEPA regulations is safe to drink’’ (the general). And the premise ‘‘the drinking water of town x meets USEPA regulations’’ (the particular). Then it follows that ‘‘town x’s drinking water is safe to drink’’ (the conclusion). Deductive reasoning involves formal rules of logic in a series of propositions, called a ‘‘syllogism.’’ A valid syllogism has a particular structural form, the subject of introductory textbooks on philosophy and logic. But not all valid syllogisms are true. The principal limitation of deductive reasoning is that, for a syllogism to be considered ‘‘sound,’’ the premises must be true. Often in scientific and regulatory policy debates the premises underlying the arguments presented are actually assertions or presumptions based on unstated assumptions, the truth of which are assumed but unknown. In the example above, if town x’s water also contained 1000 mg=L of perchlorate, a contaminant not regulated by USEPA as of this writing (2002), the soundness of this argument would be in question. The Inductive Method Francis Bacon (1561–1626) is credited with advancing the inductive method of discovering scientific truth. He formulated the basic rules of induction, which became the forerunner of Cannons of Inductive Logic, by John Stuart Mill (1806–1873). Mill’s inductive method is summarized by these rules: 1. The method of agreement—the one factor common to all antecedent situations where an effect occurs is probably the cause of the effect.

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2. The method of difference—whenever an effect occurs when A is present but not when it is absent, then A is probably the cause of the effect. 3. The joint method—the first two methods are combined when one method alone does not yield a definite result. 4. The method of concomitant variations—when an antecedent factor varies concomitantly with a consequent factor, then the former is probably the cause of the latter. The principal limitation of the inductive method is that one cannot be absolutely sure of the conclusion without complete or universal observation or knowledge, which is impossible to achieve. Nevertheless, the inductive method has played an important role in the development of public water supply. For example, in one of the first epidemiologic investigations, Dr. John Snow plotted the location of deaths from cholera on a map of central London in 1854 (see Chapter 1). The area’s 11 water pumps were also located on the map. Snow observed a correlation: that cholera occurred almost entirely among those who lived near and drank from the Broad Street water pump. He believed that the disease was caused by an unidentified microorganism in the drinking water contaminated by fecal material from diseased persons. This was a radical belief in that day (an assumption for Snow), and Snow had to argue his findings and theory before the local authorities. He was persuasive and the handle of the pump was removed, ending the neighborhood epidemic that had taken more than 500 lives. But it was not until almost thirty years later, in 1883, that Koch finally isolated Vibrio cholerae as the organism responsible for causing this disease. The Scientific Method In essence, the scientific method involves both deductive and inductive reasoning. Truth claims are determined by appeal to factual evidence, based on observation and experience. Beliefs are treated as hypotheses subject to repeat testing and open to public confirmation or refutation. Hypotheses must be tested by deducing its implications in the form of predictions and comparing them with the results of observations or experiments. The ideal hypothesis is precise and testable, accounts for the known facts, and predicts at least one new fact (Kneller 1978). In general, the scientific method involves four basic steps: 1. Formulating a statement carefully, clearly 2. Predicting the implications of such a belief 3. Performing controlled experiments to confirm or refute these implications and observing the consequences 4. Accepting, rejecting, or modifying the statement as a result The principal limitation of the scientific method is that experimentation is not always possible. Also, it is not always possible to formulate a problem in a clear and concise way that could be subjected to experimentation and observation.

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Observations do not interpret themselves, but are interpreted by a human mind, through the observer’s biases, or even by where the research dollars originated. However, a number of techniques can be used to limit the influence of bias in research (Wildavsky 1995):  Experimental Design. Experiments should be structured in advance to limit or eliminate bias to the degree possible. The experimental design should be such that the number of factors that could affect the outcome are limited and should include appropriate controls.  Replication. Scientists should disclose not only what was found in a research study but also how it was found. Experiments should be described in detail, along with a description of the controls used. If other scientists can replicate the results, it provides further evidence that the results are real and objective.  Peer Review. Scientists submit findings to scientific journals, which are reviewed by peers for possible errors or leaps in logic. The methods of experimentation should be reviewed to determine whether the experimental designs were valid and show what the author claims. Only when scientists from different areas agree that the research is valid should it be published. Properly conducted, peer review minimizes bias, and over time accumulated data tend to overthrow erroneous theories and expose fraud. Peer review is one form of ‘‘peer involvement,’’ discussed below.  Falsifiability. Well-conceived hypotheses are falsifiable. Within the constraints of the scientific method, a claim could never be considered true unless it could be proved or disproved. Indeed, a distinguishing feature of a ‘‘sound’’ science is the formation and testing of a hypothesis. Davies (1992) emphasizes the importance of hypothesis testing: A powerful theory is one that is highly vulnerable to falsification, and so it can be tested in many detailed and specific ways. If the theory passes those tests, our confidence in the theory is reinforced. A theory that is too vague or general, or makes predictions concerning only circumstances beyond our ability to test, is of little value.

Postmodern Science The modern worldview dominating Western culture for most of the twentieth century according to the presupposition that the sciences are rational. Logic is used to outline problems, interpret observations, and formulate and study hypotheses. The postmodern worldview, first articulated in 1979 by Lyotard (1997), became increasingly influential and pervasive in Western culture, especially since the early 1990s. Postmodernism argues that there is no fixed vantage point beyond our own structuring of the world. Hence, there is no thing as objective reality (i.e., something that is true regardless of whether someone believed it or not). Objective reason is considered a myth to the postmodernist. Objective understanding and the power of reason are rejected, making all scientific truth relative. What is thought to be scientific knowledge, what is considered to be a firm grasp of

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truth and reality, is viewed only as a subjective opinion. Hence, a scientific statement can be true for one person and not true for someone else. Scientific truth becomes whatever anyone decides to believe regardless of external evidence, and the common ground necessary of meaningful exchange of ideas is eroded. The power of persuasion is diminished and assertion of power over others to believe in a particular way or to control their behavior is the natural next step. A key premise of scientific relativism is that one theory is simply replaced by another because of paradigm shifts, but neither is closer to any objective truth. The scientific method is undermined or even irrelevant, as objective truth is believed not to exist, even in what is known as the ‘‘hard’’ sciences (chemistry, biology, etc.). Proponents of one scientific theory develop their own language and scientific viewpoint, with no common language between proponents of other scientific theories. What is true or rational in one scientific branch is not necessarily so in another. For example, a concept considered true by an epidemiologist would not necessarily be considered true by a toxicologist or engineer. Furthermore, no common ground on which to exchange ideas would be thought to exist between these disciplines. Each discipline develops its own worldview and language apart from the other. Hence, nothing is true and false in an absolute sense, nor is there a need for discussion between scientists or disciplines to integrate differing disciplines into a unified scientific theory or construct to describe objective reality. Something is considered true scientifically simply because it is believed, regardless of whether it is antithetical to other scientific or observable ‘‘fact.’’ An important danger in scientific relativism is that, once the ties between belief and objective reality become severed, irrational beliefs in any discipline may become firmly entrenched and difficult to change. Wynn and Wiggins (2001) note that Once people acquire a belief, they tend to adhere to that belief, even in the face of contradictory evidence. Explanations developed to explain phenomena become fixed, even when those explanations are shown to be irrational or based on wrong evidence.

The disconnections between disciplines and the divergence of views regarding the role of rational thought described above can be the source of extreme conflict over the soundness of a scientific study. Indeed, inherent in the postmodern worldview and scientific relativism is a serous contradiction—observation and logical inference are used to argue that observation and logical inference tell us nothing. By using the tools of science to argue its views, the postmodern view demonstrates the belief that these tools actually work, rather than that these tools are worthless. Arguing that scientific relativism is universally true is internally inconsistent and contradictory. The postmodern view also has serious ramifications for public water supply. Consider the waterborne disease outbreak in Walkerton, Ontario, in which there were 11 deaths and more than 1000 people infected in a population of 5000 (O’Conner 2002). Sincere citizens believed that the water was safe to drink, which governed their behavior to drink the water in the first place, but did not invalidate the objective reality external to the victims that disease-causing microorganisms were present in their drinking water.

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Scientific relativism within the postmodern view undermines the very concept of a universally applicable ‘‘sound’’ science. Although imperfect, science attains the goal of discovering, to the degree possible, an objective, rational truth much of the time. Reflecting on this nature of science, Ziman (2000) concludes To put it simply . . . scientists still formulate and try to solve practical and conceptual problems on the basis of their shared belief in an intelligibly regular, not disjointed, world outside themselves. They still go on theorizing, and testing their theories by observation and experiment. They still try as best they can to eliminate personal bias from their own findings and are extremely canny in their acceptance of the claims of others. To that extent at least, we, the public at large, have just as good grounds as we ever did for believing (or doubting) the amazing things that science tells us about the world in which we live.

9.2.3

Clarity

Lack of clarity can originate from areas already discussed: lack of objectivity and poor reasoning. However, it can also originate from doublespeak, unclear definitions, and unstated presumptions. ‘‘Doublespeak’’ is language that pretends to communicate but really does not. Basic to doublespeak is incongruity between what is said or left unsaid, and what really is (Lutz 1989): It is the incongruity between the word and the referent, between seem and be, between essential function of language—communication—and what doublespeak does— mislead, distort, deceive, inflate, circumvent, obfuscate.

There are at least four kinds of doublespeak:  Euphemism—an inoffensive or positive word or phrase used to avoid a harsh, unpleasant, or distasteful reality. Not all euphemisms are doublespeak, but become so when used to mislead or deceive.  Jargon—the specialized language of a trade, profession, or similar group. Within a group, jargon functions as a verbal short hand allowing members of the group to communicate with each other clearly, efficiently, and quickly. But jargon can also be doublespeak when it is pretentious, obscure, and esoteric terminology used to project an air of profundity, authority, and prestige. Jargon doublespeak makes the simple appear complex, the ordinary profound, the obvious insightful. When a member of a group uses its jargon to communicate with a person outside the group, and uses it knowing that the nonmember does not understand the language, it is doublespeak.  Gobbledygook or bureaucratese—overwhelming the hearer with words, the bigger the words and the longer the sentences, the better. Gobbledygook sounds impressive, but when examined in print, usually does not make sense.

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 Inflated language—language designed to make the ordinary seem extraordinary, to make everyday things seem impressive, to give an air of importance to people, situations, or things that would not normally be considered important, to make the simple seem complex. Ambiguous definitions can also result in confusion and, in some cases, doublespeak. Many words have more than one definition. Meaning can be hidden or confused when definitions of words change in a statement or study, or have inserted presuppositions. Lastrucci (1963) notes that a good definition can be neither true nor false. It is not a factual position. A definition is simply an explicit declarative statement or resolution; it is a contention or an agreement that a given term will refer to a specific object. It cannot be logically tested for ‘‘truth.’’ Its ‘‘truth’’ is established by declaration; it is what the definer says it is. Lack of clarity results when a scientist or regulator interjects a presumption within a definition or statement, or changes the meaning of a word in midsentence. For example, how should the term ‘‘safe drinking water’’ be defined? An operational definition might be ‘‘Safe drinking water is water that meets current drinking water regulations.’’ But this statement contains a presumption that current drinking water regulations are sufficient to protect public health. We might then define ‘‘safe drinking water’’ as water that poses no significant risk to public health. What is ‘‘significant’’? How do we define ‘‘public’’? What about sensitive people within the general population? And what about contaminants that are not regulated? Hence, a definition of ‘‘safe drinking water’’ could mean many things. Indeed, suppose a customer calls their water company asking ‘‘Is my water safe to drink? And the water company representative responds by saying ‘‘Yes, it meets all current regulations.’’ Both customer and water company representative may likely feel satisfied, but should they be? All rational disciplines, including the scientific method, take certain things for granted. These beginning points are called presuppositions, things considered true even though they cannot be proved within that particular discipline, or proved at all. All knowledge has certain beginning points that are simply to be accepted, and that are impervious to scientific methods. Indeed, differences regarding whether a particular study constitutes sound science can arise simply because presuppositions are unstated, or because investigators view the study through a different perspective based on differing presuppositions and basic assumptions. 9.2.4

Critical Thinking

A prerequisite to being able to fairly evaluate scientific studies is the development of good thinking habits, or, in short, learning to think critically. In this context, critical thinking is the disciplined art of ensuring that the best thinking one is capable of is used to evaluate the scientific study in question. Paul and Elder (2001) note that a well-disciplined critical thinker  Raises vital questions and problems, formulating them clearly and precisely  Gathers and assesses relevant information, and can effectively interpret it

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 Comes to well-reasoned conclusions and solutions, testing them against relevant criteria and standards  Thinks open-mindedly within alternative systems of thought, recognizing and assessing, as need be, their assumptions, implications, and practical consequences  Communicates effectively with others in figuring out solutions to complex problems A basic component of critical thinking is fair-mindedness. To be fair-minded is to treat every viewpoint relevant to a study in an unbiased, unprejudiced way. By nature, humans tend to prejudge the views of others, placing them into ‘‘favorable’’ (agrees with us) and ‘‘unfavorable’’ (disagrees with us) categories. Less weight tends to be given to contrary views, especially when political motives are involved. When recognizing mistakes in reasoning, commonly called ‘‘fallacies’’ (Table 9.1), most people will tend to see the mistakes in the reasoning they already disapprove of rather than in their own reasoning. Although they can develop some proficiency in making their opponents thinking look bad, subjecting their own thinking to similar scrutiny might yield similar limitations. Fair-mindedness entails treating all viewpoints alike (evaluating all views or aspects of a study according to the same criteria), uninfluenced by a particular person or group’s advantage. This does not mean that all viewpoints are equally true or equally acceptable, but it does mean that they are evaluated fairly with the same criteria and thinking processes before acceptance, rejection, or modification.

9.3

PEER INVOLVEMENT

The quality and credibility of scientific studies forming the basis of regulatory policies can be enhanced through peer involvement. Peer involvement is generally considered to be the process whereby an investigator or agency staff involve subject matter experts from outside their own program in one or more aspects of a study or development of a work product. It is an active outreach to and participation by the broad scientific, engineering, and economics communities beyond the investigator’s organization (external) as well as within the investigator’s organization (internal). In general, peer involvement takes two forms: peer input and peer review. Peer input, sometimes called peer consultation, generally refers to an interaction during development of a study, policy, or work product, providing an open exchange of data, insights, and ideas. It may be characterized by a continual iterative interaction with scientific experts during the study or work product development. Peer input provides contributions to the development of the study or work, but does not substitute for peer review, which is more rigorous. There is no written definition of peer review that applies across the federal government (USGAO 1999). In general, the goal of peer review is to obtain an independent, third-party review of the product from experts who have not substan-

9.3 PEER INVOLVEMENT

TABLE 9.1

207

Directory of Fallacies

Ad hominum: attacking the person rather than his or her arguments Ad ignorantiam (appeal to ignorance): arguing that a claim is true just because it has not been shown to be false; arguing from incomplete information Ad misericordiam (appeal to pity): appealing to pity as an argument for special treatment Ad populum: appealing to the emotions of a crowd; appealing to a person to ‘‘go along’’ with the crowd, without presenting any reasons to show that the crowd is an informed or impartial source Affirming the consequent: a deductive fallacy of the following form: If p then q q Therefore, p Both premises could be true and the conclusion still false; overlooks alternative explanations Begging the question: implicitly using your conclusion as a premise; assuming the issue in question in your response Complex question: posing a question of issue in such a way that one cannot agree or disagree with you without committing oneself to some other claim you wish to promote Composition: assuming that a whole must have the properties of its parts; opposite of ‘‘division’’ Denying the antecedent: a deductive fallacy of the form: If p then q Not p Therefore, not q Both premises could be true and the conclusion still false; overlooks alternative explanations Division: assuming that the parts of a whole must have the properties of the whole; opposite of ‘‘composition’’ Equivocation: using a word in more than one sense False cause: generic term for a questionable conclusion about a cause and effect False dilemma: reducing the options you consider to just two, often sharply opposed and unfair to the person against whom the dilemma is posed (arguing from a false dilemma is sometimes a way of not playing fair, and it overlooks alternatives) Loaded language: using language whose only function is to sway the emotions of the readers or hearers, either for or against the view you are discussing; making your argument look good by caricaturing the opposite side Nonsequitur: drawing a conclusion that ‘‘does not follow’’; a conclusion that is not a reasonable inference from the evidence; this is a very general term for a bad argument— try to determine specifically what is (supposed to be) wrong with the argument The ‘‘person who’’ fallacy: allowing one vivid example to outweigh a careful examination of data Persuasive definition: defining a term in a way that appears to be straightforward but that in fact is subtly loaded (positively or negatively) Petitio principii: Latin for ‘‘begging the question’’ Poisoning the well: using loaded language to disparage an argument before even mentioning it (continued )

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TABLE 9.1

(Continued)

Post hoc, ergo propter hoc (literally, ‘‘after this, therefore because of this’’): assuming causation too readily on the basis of mere succession in time Provincialism: mistaking a local fact for a universal one Red herring: introducing an irrelevant or secondary subject and thereby diverting attention from the main subject; usually the red herring is an issue about which people have strong opinions, so that no one notices how their attention is being diverted Straw man: caricaturing an opposing view so that it is easy to refute Suppressed evidence: presenting only the part of a piece of evidence that supports your claim while ignoring the parts that contradict your claim Weasel word: changing the meaning of a word in the middle of your argument, so that your conclusion can be maintained, though its meaning may have shifted radically

tially contributed to its development. When experts have a material stake in the outcome of the peer review (such as a regulated entity) or have participated substantially in the development of the product, their reviews are more appropriately referred to as peer input. Peer review involves an indepth assessment of the assumptions, calculations, extrapolations, alternative interpretations, methodology, acceptance criteria, and conclusions of the study or work product and of the supporting documentation. USEPA (1998) and other government agencies (USGAO 1999) have formal peer review guidelines and policies. Scientists, regulators, and other stakeholders—no matter how brilliant—simply cannot think out every thing for themselves all of the time, nor do they have expertise in all areas involved in drinking water regulation. Much of the time, no alternative exists except to trust the experts in a particular area. But can they be trusted? Experts carefully selected will certainly be knowledgeable in their subject area, but they also may have an interest in furthering a view that is in their own interests, delivering what is popularly known as a ‘‘snow job.’’ The late physicist Richard Feynman, a recognized leader of modern science, described most appropriately qualities of a trustworthy expert and the importance of scientific integrity in a 1974 commencement speech at the California Institute of Technology. Feynman (1989) told the graduating class to cultivate a kind of scientific integrity, a principle of scientific thought that corresponds to the kind of utter honesty—a kind of leaning over backwards. For example, if you’re doing an experiment, you should report everything that you think might make it invalid—not only what you think is right about it: other causes that could possibly explain your results; and things you thought of that you’ve eliminated by some other experiment, and how they worked—to make sure the other fellow can tell they have been eliminated . . . . In summary, the idea is to try to give all the information to help others to judge the value of your contribution; not just the information that leads to judgment in one particular direction or another. The first principle is that you must not fool yourself—and you are the easiest person to fool. So you have to be very careful about that. After you’ve not fooled yourself, it’s

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easy not to fool other scientists. You just have to be honest in a conventional way after that. I would like to add something that’s not essential to the science, but something I kind of believe, which is that you should not fool the layman when you’re talking as a scientist. I’m talking about a specific extra type of integrity that is [more than] not lying, but bending over backward to show how you’re maybe wrong, that you ought to have when acting as a scientist. And this is our responsibility as scientists, certainly to other scientists, and I think to laymen.

In sum, trustworthy experts are those who  Understand their responsibility to provide their expertise without claiming to know more than they really do  Seek to conduct scientific studies of the highest quality  Don’t try to evade questions or difficulties  Pursue objectivity, reason, and clarity  Apply fair-minded, critical thinking Over time, experts in a field of study develop a reputation on the basis of a track record of the quality of their work, actions, and public statements. They may become generally regarded as a reliable, trustworthy resource—a process generally referred to as peer regard. Reliance on trustworthy experts is essential for peer involvement—peer input and peer review—to be effective.

9.4

SCIENTIFIC DISAGREEMENT

Scientists often disagree. The same can be said for engineers, architects, and all other scientifically based disciplines. Even the use of peer-reviewed science will not, unfortunately, guarantee agreement among all parties. Scientists often weigh differing strands of evidence and supporting data differently. But disagreement among scientists does not by itself mean that a particular scientific view is unsound; that depends on the available evidence. In its report, Setting Priorities for Drinking Water Contaminants, a committee of the National Research Council (NRC 1999) addressed the issue of scientific disagreement as it applies to evaluating contaminants in drinking water for possible regulation: [The committee] takes the position that scientific disagreements are the norm and do not signal a deviation from sound science. These disagreements may be based on values other than strictly scientific ones, however, this does not mean that the sides of the debate are not based on sound science. Indeed, it is not unusual for scientists to disagree on the application of sound science to public policy issues. Any scheme that affects the provision of public water is likely to engender legitimate scientific disagreement. The

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report also recognizes that identifying and agreeing on what is sound science is itself a difficult and error-prone enterprise. It therefore makes no recommendations on what ‘‘soundness’’ entails, letting the accepted mechanisms of peer regard, peer review, and scientists’ habits of critical thinking continue to serve as the ultimate arbiters.

In an atmosphere of high mistrust, disagreements can cause breakdown in communication and fracture relationships between scientists and=or stakeholders. But when trust is maintained, disagreement can stimulate discussion and lead to better solutions. In a sense, the more vigorous the discussion between trustworthy experts and=or stakeholders, often the better the resulting solution. In some cases, a neutral third-party facilitator is necessary for stakeholders or groups of scientists to communicate with each other when disagreement is high or emotionally charged and trust is low. (See Chapter 11 for a discussion of public involvement.)

9.5

‘‘JUNK’’ SCIENCE

In recent years the idea has arisen that certain studies are so poor as to warrant being called ‘‘junk science’’ (Milloy 2001). Junk science is argued to be the source of many health scares and scams. Specifically, ‘‘junk science’’ is defined as (Milloy 2001) the manipulation of statistics to promote special policy agendas that have nothing to do with public health and safety. It can be disseminated by special interest groups, social and political activists, businesses seeking to hurt rival companies, and politicians. Unfortunately, many gullible journalists pass on the bad information, alarming the public and causing much harm.

It is well known that measurements and statistics can be manipulated to deliberately deceive (Brignell 2000, Lutz 1989, Huff and Geis 1993), and studies must be carefully evaluated if this is suspected. But the fact that measurements and statistics are used in a study does not mean that the weaknesses of a study are deliberately intended. Technical studies and research typically involve data collection, analysis, and interpretation (Bendat and Piersol 2000). Furthermore, scientific techniques have limitations. Even so, all studies have strengths, weaknesses, limitations, and appropriate applications. Indeed, there is no generally accepted, uniform criterion or set of criteria by which to identify a particular study as ‘‘junk,’’ although Milloy (2001) has proposed such criteria particularly with regard to interpreting epidemiologic data. Evaluation of a study according to such criteria may serve a useful purpose in sharpening the interpretation and application of a study. But simply labeling a study as ‘‘junk,’’ is generally not helpful to fairly assess the strengths and weaknesses of a particular study and often serves more as a colorful political device to further an agenda. In general, data should not be categorically discarded, even from weak studies. The merits and applicability of each study must be considered in light of its strengths and weaknesses. Distortion or misinterpretation of scientific findings by news media can cause unnecessary alarm and cloud the proper interpretation of a study (Murray et al. 2001, Best 2001).

9.6 CAUSATION AND CAUSAL INFERENCE

9.6

211

CAUSATION AND CAUSAL INFERENCE

Vigorous debate over the ‘‘soundness’’ of scientific studies is perhaps most intense in the area of assessing causation, especially causation in relation to health effects of drinking water contaminants. Causation and causal inference have been discussed in Chapters 6 and 7, and are reviewed in detail by Klaassen (2001) and Rothman (1998). Scientific studies are performed by imperfect scientific people using imperfect scientific methods and techniques. Indeed, they must be properly evaluated applying fair-minded, critical thinking, and appropriate criteria (i.e., Tables 9.1 and 9.2). Toxicologists and epidemiologists (and engineers as well as water plant operators) are trained in their respective disciplines to think differently from one another, usually start with differing fundamental assumptions, and have differing analytical approaches. Hence, debates over the interpretation and meaning of toxicologic and epidemiologic studies can be sharp. Toxicology and epidemiology are discussed further in Chapters 6 and 7, respectively. An excellent case study of the difficulties in assessing causation and disputes between disciplines is provided in USEPA’s regulation of chloroform in drinking water. Chloroform is regulated as one of the total trihalomethanes (TTHMs). In 1994, USEPA proposed a maximum contaminant level goal (MCLG) for chloroform. At that time, the agency assumed, because of a lack of data to the contrary, that there was no safe threshold for chloroform’s potential carcinogenic effects. On the basis of this assumption, the agency initially proposed an MCLG of zero for chloroform. Subsequent to this proposal, extensive new science became available concerning the carcinogenicity of chloroform. USEPA considered these data, and concluded that a genotoxic mechanism was not likely to be the predominant influence of chloroform on the carcinogenic process, and that there was a reasonable scientific basis to conclude that the chemical caused cancer through cytotoxicity. This conclusion was counter to the agency’s longstanding policy of setting MCLGs for potential carcinogens at zero. At issue was the strength of the large body of experimental evidence for cytotoxicity, as opposed to a genotoxic mechanism, and how that evidence should be applied to regulate chloroform. USEPA’s proposal to set a nonzero MCLG for chloroform was vigorously opposed by environmental groups and many epidemiologists, who were skeptical of the experimental evidence. On the other hand, toxicologists were more likely to be convinced of the experimental evidence, even going as far as to take a popular vote in strong support of a nonzero MCLG for chloroform at a session held at the 2000 Society of Toxicology Conference. How much experimental or other evidence is necessary to justify a regulatory decision concerning the MCLG (or MCL, for that matter) that is counter to a longstanding policy assumption, as in the case of chloroform, or political pressure? There is no simple answer to this question. Rothman (1998) notes that Even when they are possible, experiments (including randomized trials) do not provide anything approaching proof and in fact may be controversial, contradictory, or irreproducible . . . . Laboratory studies often involve a degree of observer control that cannot be approached in epidemiology; it is only this control, not the level of observa-

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TABLE 9.2

Potential Errors in Environmental Studies

Were appropriate controls used? The control group in health effect studies must be as similar as possible to the study group except for the exposure of interest If the study group has a characteristic that the control group does not have and that could cause the effect of concern, then a ‘‘false-positive’’ result may be derived from the experiment A ‘‘false-positive’’ is an erroneous correlation between exposure and health effect, which leads to a wrong conclusion Important factors to consider in establishing a control group in a human epidemiological study are the effects of age, smoking, gender, and preexisting conditions Controls are also important in nonhuman, scientific studies to isolate the variable(s) or phenomenon(a) of interest and minimize or eliminate confounding factors Was an appropriate baseline established? Increases and decreases are observed partly because of the existing data and convenience and partly because of the point the researcher has in mind In some cases, knowing where the baseline begins is necessary to properly evaluate the study results Was the baseline varied to determine whether the conclusion is robust? Would the conclusions be affected if a different baseline were chosen If the conclusion is the same no matter what the baseline, the study is on firmer ground Are conclusions extrapolated from the ‘‘parts’’ to the ‘‘whole’’? Observing effects on a micro scale (e.g., biochemical reaction) may not indicate effects on a macro scale (e.g., organism) Conclusions drawn from experiments on separate components do not necessarily apply to the whole unit Were direct measures used? Direct measures should be used for the important factors, characteristics, effects, etc. Indirect measurements may be useful, but they may not necessarily indicate directly the effect or phenomena under investigation Are the stated trends consistent across the measured data? Following trends in data decreases reliance on appearances and guesses Do the measured data consistently support the claims and conclusions made Was the normal range for the phenomenon in question established as a standpoint from which to judge trends? Establishing the normal or typical variation of a phenomena or measurement is important, if possible Effects within the normal range may not be attributable to a cause Excursions from the normal range are the phenomena of interest, not variations within the normal range Were the same types of measurements used consistently? Measurements must be accurate and correct Measurements must also be compatible if they are to be compared to historical data or other measures Actual measurements are generally preferable to model estimates: Accuracy and reliability depend on actual measurements Model estimates must be validated by actual measurements Models are not reality, but descriptions of reality or of a phenomena

9.6 CAUSATION AND CAUSAL INFERENCE

TABLE 9.2

213

(Continued)

Rely as little as possible on model extrapolations that are difficult or impossible to verify and as much as possible on actual measurements Be aware of recall bias in conducting surveys and assessing exposure: Memory and recall have been proved to be unreliable. Exposure assessments should rely on actual measurements whenever possible Consider the duration of exposure: Short-term exposures will differ in effects from chronic exposures Evaluate separate effects to determine if there is really something to be concerned about: Clusters of effects or use of surrogate measures can be misleading Specific effects must be identified and measured Be aware of extrapolation from high to low doses: Establishing an effect at a high exposure level is easier than at low exposure levels It is usually assumed that there is no safe dose, however low, for a chemical that has been shown to be a hazard at however high a dose In toxicology, ‘‘the dose makes the poison;’’ this means that the larger the dose, the greater the effect However, there may be no scientific basis for assuming that a chemical is dangerous at low doses just because it is dangerous at high doses; such an assumption is usually made by regulatory agencies as a policy assumption Many substances are beneficial at low doses but toxic at higher doses Has a mechanism been firmly established? A cause must precede its effect A cause and an effect must be connected in order for definitive conclusions to be reached Knowing that a plausible mechanism has not yet been identified or tried out should provoke skepticism Have conditions of applicability been established? Under what conditions do the conclusions or observations apply? Do not accept residual explanations: Do not accept the reasoning that if it is not X or Y, it must be Z, when other possibilities exist Be on the lookout for logical fallacies (see Table 9.1) Don’t draw final conclusions from one study: If a chemical is truly responsible for an effect, then similar studies of that chemical should show similar effects Scientists must be able to replicate results before they can confirm or deny the causal implications of a study that shows a correlation between exposure and illness Look to other studies for confirming or contradicting results Be skeptical: Environmental studies may be flawed because of one or more errors Whether the claims are of excessive harm or of no harm at all, they should be approached on a ‘‘show me’’ basis On complicated issues, keep score, and think carefully: Track the supporting evidence and conflicting expert opinions Do not discard data, even from weak studies; consider the merits of each study in light of its strengths and weaknesses Separate out rival arguments so that the evidence pro and con can be accumulated (continued )

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TABLE 9.2

(Continued)

Apply fair-minded thinking to evaluate divergent views: Welcome differences of opinion, because they may bring new insights By comparing evidence supporting and opposing rival views, new insights are likely to emerge Often, the more vigourous the fair-minded discussion of opposing views that occurs, better solutions and conclusions are fashioned Evaluate data analytical techniques and results carefully Data analysis techniques and statistics must be appropriate to the data sets analyzed Statistical tests must be properly interpreted Alternative interpretations of data should be considered

tion, that can strengthen the inferences from laboratory studies. And again, such control is no guarantee against error.

As a body of scientific knowledge is developed over time, discoveries and conclusions might challenge conventional thinking or longstanding policy. In the case of the chloroform MCLG, court action was necessary for resolution of the issue, discussed below.

9.7

SCIENCE AND SDWA REGULATIONS

The U.S. Environmental Protection Agency’s (USEPA’s) Office of Ground Water and Drinking Water (OGWDW) has set forth the objective to implement a balanced public health protection program based on ‘‘sound science and adequate data’’ (Dougherty 1996) Indeed, the 1996 Safe Drinking Water Act (SDWA) amendments specifically requires USEPA to the degree that an agency action is based on science, to use the best available, peer-reviewed science and supporting studies conducted in accordance with sound and objective scientific practices, and use data collected by accepted methods or best available methods (if the reliability of the method and the nature of the decision justifies use of the data). Given the added importance of science to the SDWA rulemaking endeavor, the sharp disagreements that can often exist as to what constitutes ‘‘good’’ or ‘‘sound’’ science become more significant. At various times within the regulatory process, stakeholders should take full opportunity to engage in discussions with USEPA and other stakeholders regarding the adequacy of science forming the basis of regulations and regulatory policy. The regulatory process is helped, not harmed, by the formulation and defense of different hypotheses that extend beyond known facts (Wildavsky 1995). But the criteria for what counts as knowledge, the epistemology of science, must remain high. Emphasis is needed on the quality of science, not who performed or funded the study. Wildavsky (1995) argues that replacing a scientific hierarchy of values and the honoring of common scientific standards with inchoate feelings shifts the focus from

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searching for universal truths on which to base decisions to the expression of personal testimonies. What is true becomes far less important or even irrelevant, as in the case of the postmodern view, compared with what is personally authentic. Not all regulatory decisions are based on science. Although science cannot answer every question, replacing science with sincere feelings undermines the scientific underpinnings of good decisionmaking. Otherwise sound science becomes defined by an eminent authority, or by whomever is in power, or by whomever can overpower everyone else. Throughout the drinking water regulatory development process, stakeholders and USEPA present and evaluate expert opinions, scientific and engineering data, modeling results, and other forms of information. Deliberations occur over scientific data with arguments for and against positions, policies, and regulatory options. Disagreement among experts as to what is true can sometimes leave stakeholders at a loss as to the best way to approach a regulatory issue. Scientific truth is not infallible, and can change over time. Disagreement regarding sound science is to be expected as experts move beyond facts that can be proved using a scientific protocol or logical reasoning to express beliefs that cannot be scientifically documented. Scientific integrity depends on institutions that maintain competition between scientists, and scientific groups who are numerous, dispersed, and independent. Scientific claims should be subject to replication and verification. Informed opinions of scientific and engineering experts are needed throughout the regulatory process, in terms of what is scientifically factual as well as what may be possible, probable, and improbable.

9.8

SCIENCE AND THE COURTS

The courts have an important oversight role regarding USEPA’s application of science. Chapter 22 reviews the role of the courts in assessing science in legal proceedings related to toxic tort cases. SDWA provisions allow a petitioner to challenge the science behind a USEPA regulatory action, as discussed below.

9.8.1

Judicial Review

The SDWA gives the federal courts jurisdiction to review USEPA actions. Section 1448 of the SDWA allows for judicial review of actions regarding primary drinking water regulations (including MCLGs). A petitioner must file in the U.S. Court of Appeals for the District of Columbia Circuit. The judicial review process is discussed in the following sections, and additional details are available elsewhere (Mintz and Miller 1991, Prillaman and Rubin 1992). Petitions must be filed not later than 45 days after a regulation has been promulgated or an order has been issued, with one exception. A petition can be filed later if it is based solely on grounds arising after the expiration of such period. Filing a petition within this time limit is critical. Any USEPA action not petitioned against

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within the period will not be subject to judicial review in any civil or criminal proceeding for enforcement or in any civil action to enjoin enforcement. A key question in any court proceeding is whether a petitioner has ‘‘standing’’ to bring the lawsuit. Standing is a concept derived from several court decisions interpreting provisions of the U.S. Constitution that authorize the judiciary to exercise its authority only when alleged personal injury is fairly traceable to the purportedly unlawful conduct and is likely to be redressed by the requested relief. Harm can be actual or threatened, but it must be distinct and palpable. Harm to an ideological interest is insufficient. Only an organization, group, or individual that has standing could challenge the soundness of the science underlying a USEPA rule. The principles of standing were explained in a 1991 decision of the U.S. Court of Appeals for the DC (District of Columbia) Circuit (Court), which reviewed a challenge to several MCLs promulgated by USEPA in January 1991 (Court of Appeals 1992). The petitioners in that case included the International Fabricare Institute (IFI), an organization of dry cleaners that use perchloroethylene, and several major manufacturers, including Dow Chemical Company and Shell Oil Company. In response to USEPA’s challenge to the petitioners’ standing, the Court of Appeals (1992) ruled: An organization such as IFI may have standing, even when the organization itself has not suffered an injury, if it can show that (1) its members would otherwise have standing to sue in their own right; (2) the interest it seeks to protect are germane to the organization’s purpose; and (3) neither the claim asserted nor the relief requested requires the participation of individual members in the lawsuit.

The court also stated that there must be some indication, even slight, that the litigant before the court was intended to be protected, benefited, or regulated by the statute under which the suit was brought. The court agreed that there was sufficient basis to grant the dry cleaners’ standing to challenge USEPA actions because MCLGs are used by USEPA to establish liability under the Superfund. As for the manufacturers, the court was satisfied that they operate public water systems and therefore would be directly regulated by the MCLs.

9.8.2

The Judicial Review Process

An overview of the judicial review process is provided in Figure 9.1. A lawsuit commences with the filing of a brief statement by the petitioner in the U.S. Court of Appeals after the final regulation is published in the Federal Register. This ‘‘petition for review’’ identifies the formal citation to the regulation, but need not and usually does not identify the particular issue(s) the petitioner finds objectionable. The petition is usually short, about one page in length. Multiple parties may file petitions on any given rule. After a petition is filed, there is a 30-day period within which another party may file to intervene. An intervenor may join on the side of USEPA to help defend a regulation, or on the side of the petitioner to provide support in challenging a regulation. All petitions are initially handled as separate lawsuits. The court eventually consolidates the cases, that is,

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217

Figure 9.1 Judicial review process.

groups them together in one case before the court. A petitioner may request that the court isolate its petition into a separate case if reason exists to do so. The Supreme Court has ruled that challengers to a regulation litigate on their own time; that is, a regulation will remain in effect during the course of the challenge, unless the USEPA or the court issues a ‘‘stay’’ (postponement) of the regulation pending appeal. SDWA regulations are complex, and often have thousands of pages of documentation in the administrative record. Several months are usually required for both the petitioner and USEPA to identify and consider all the pertinent facts and legal

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arguments relating to the challenge. Typically, USEPA or a petitioner will request the court delay by setting up a formal schedule for submitting briefs and presenting oral arguments to the court. A request for a delay is presented in the form of a motion. A motion seeks to establish a schedule within which the parties can consider settlement and provides that, should settlement discussions fail, the parties will agree to return to the court to establish a schedule to submit briefs. In case out-of-court negotiations fail, the Court of Appeals sets a briefing schedule. Petitioners are given a certain period of time within which to file briefs that present the arguments for overturning the regulation. USEPA is then given a period of time to respond. Occasionally, a party may intervene on the side of USEPA or on the side of the petitioner. That party, referred to as an ‘‘intervenor,’’ files a supportive brief at the same time according to the briefing schedule. Petitioners are then given a short period of time, usually 14 days, to file a reply brief. The judicial review is limited to the administrative record for the rule in dispute. Briefs seldom contain new information, but instead focus the court’s attention on deficiencies in the rulemaking record. Typically, the petitioner will identify pertinent portions of the statute and case law in support of the petitioner’s contention that the court should act to overturn (or uphold) a regulation. The court will schedule the case for oral arguments, which in some cases may be years after filing of the initial petition. Each side is given 15 minutes, sometimes up to an hour, to address a panel of three judges (Court of Appeals 1984). The primary purpose of oral argument is not to repeat what has already been stated in the briefs, but to respond to questions the judges will raise about the arguments and facts in dispute. The law establishes no specific timeframe within which the court must issue a written decision. The court of appeals typically does one of three things. It may affirm a regulation in its entirety; it may overturn a regulation and remand it for further consideration by the agency; or it may direct USEPA to take specific action. The court may choose to affirm one portion of the regulation, overturn another portion, and direct USEPA to take specific action on yet another portion of the regulation. If the court rules entirely in favor of the agency, the regulation remains in place, as is. If the court rules in favor of the petitioner, to the extent that the court has overturned the regulation, ordinarily that portion of the regulation objected to is no longer in effect.

9.8.3

Deference

The Court of Appeals has construed the applicable principles of the Administrative Procedure Act to require it to give substantial deference to USEPA when reviewing its rules. The Court of Appeals (1992) has stated We will reverse [a] USEPA action only if it is arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law . . .. This highly deferential standard of review presumes Agency action to be valid . . . . The rationale for deference is particularly strong when USEPA is evaluating scientific data within its technical expertise; In an area characterized by scientific and technological uncertainty, . . . this

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court must proceed with particular caution, avoiding all temptation to direct the Agency in its choice between rational alternatives. Despite this deferential standard, we must [e]nsure that USEPA has examined the relevant data and has articulated an adequate explanation for its action . . . . The USEPA is required to give reasonable responses to all significant comments in a rulemaking proceeding . . . . We will therefore overturn a rulemaking as arbitrary and capricious where USEPA has failed to respond to specific challenges that are sufficiently central to its decision.

In short, the court has decided that USEPA’s interpretation of its own regulation will be accepted unless it is plainly wrong. Of course, a rule may not be wrong, but still be based on marginal science. Even so, the court’s job is not to determine whether USEPA’s judgments are correct, but whether they are properly reasoned. Overall, USEPA has had remarkable success in defending against challenges to drinking water regulations issued under the SDWA. Given the great deference granted to the agency by the court, a rulemaking or portion thereof must be clearly incorrect or fatally flawed to justify an appeals court ruling that it is arbitrary and capricious. In cases where the science is unclear, or equally qualified experts disagree, the court will defer to the scientific judgments made by the agency. This critical point must be carefully considered by anyone contemplating a legal challenge to a USEPA drinking water rulemaking on scientific grounds—the court will presume the agency to have made correct judgments of science, and it will be up to the petitioner to prove that the agency was clearly wrong. In general, disagreements between reasonable scientists and engineers within the agency and the regulated community during the course of development of a rulemaking will generally not be sufficient to justify an arbitrary and capricious ruling. The burden of proof is on the petitioner to show that the agency is incorrect. 9.8.4

Example: Chloroform MCLG

In some respects, ‘‘sound’’ science is what the courts say it is, at least in regard to scientific disputes that are elevated through court action. As noted above, the courts typically defer to agency judgments regarding science. However, Pontius (2000) and Quill and Fischer (2000) have reviewed the notable case of chloroform, mentioned above, where the court ruled that USEPA had indeed violated the SDWA by failing to use the best peer-reviewed science in setting the MCLG (Court of Appeals 2000). There are several aspects of this case that greatly influence the agency’s application of science in rulemakings. As mentioned previously, USEPA proposed an MCLG of zero for chloroform in 1994. At that time, the agency assumed, because of a lack of data to the contrary, that there was no safe threshold for chloroform’s potential carcinogenic effects. Subsequent to this proposal, extensive new science became available concerning chloroform’s carcinogenicity. USEPA considered these data in special Notices of Data Availability (NODAs) in 1997 and 1998, to seek comment on the new data and analysis on chloroform. The 1998 NODA concluded that a genotoxic

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mechanism was not likely to be the predominant influence of chloroform on the carcinogenic process, and that there was a reasonable scientific basis to conclude that the chemical caused cancer through cytotoxicity. In December 1998, USEPA published its final rule establishing the MCLG for chloroform. Although the agency reaffirmed the findings in the 1998 NODA, it did not apply those findings to the final rule, and set the MCLG for chloroform at zero. According to press reports, the Clinton administration bowed to pressure from environmentalists in making this decision (Inside Washington Publishers 1998). The Chlorine Chemistry Council (CCC), a business council of the American Chemistry Council, along with other industry petitioners, filed a petition for review, arguing that the agency violated the SDWA requirement to ‘‘use the best available, peer reviewed science’’ when it promulgated the zero MCLG for chloroform. Typically, petitioners will challenge a rulemaking by questioning the agency’s scientific determinations. In this case, CCC and others sought to compel USEPA to apply its own scientific conclusions, rather than the scientific conclusions of others. This lawsuit drew much attention, prompting amicus (i.e., Friend of the Court) briefs by a group of 13 reputable scientists and by Rep. Thomas Bliley (R–VA), chair of the House Commerce Committee. Both amicus briefs supported CCC’s petition. In a rare action, USEPA asked the Court of Appeals on Feb. 24, 2000 to vacate or invalidate the chloroform MCLG it issued Dec. 16, 1998 (BNA 2000a, 2000b). Hence, whether the MCLG for chloroform should have been set at zero was no longer at issue. Even so, an important issue before the court was whether the agency had violated the law by not proceeding in 1998 with the best science at hand, but delaying the decision for Science Advisory Board (SAB) review. On March 31, 2000, the U.S. District Court issued a ruling vacating the MCLG for chloroform, finding that USEPA had indeed violated the SDWA by failing to use the best available peer-reviewed science in setting the MCLG (Court of Appeals 2000). The court found the zero MCLG to be arbitrary and capricious and in excess of statutory authority. The fact that the agency arrived at a novel, politically charged outcome, was deemed of no significance. The DC Circuit Court ruled in favor of the petitioners, concluding that ‘‘[i]n promulgating a zero MCLG for chloroform, EPA openly overrode the ‘‘best available’’ scientific evidence, which suggested that chloroform is a threshold carcinogen.’’ The court also rejected the agency’s rationale that it adopted a zero MCLG because it wished to consult further with its SAB about chloroform’s carcinogenicity. The court found that ‘‘however desirable it may be for EPA to consult an SAB and even to revise its conclusion in the future, that is no reason for acting against its own science findings in the meantime.’’ Significantly, the court concluded that ‘‘EPA cannot reject the ‘best available’ evidence simply because of the possibility of contradiction in the future by evidence unavailable at the time of the action—a possibility that will always be present.’’ The DC Circuit’s findings have two important implications: (1) an agency may be acting illegally when it relies on default assumptions when the best available science supports less conservative approaches for assessing risk and (2) the best

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available science is the scientific evidence that is available at the time of a rulemaking. The possibility of contradiction based on further scientific data or peer review is not a legitimate basis for rejecting the science that currently exists. 9.9

FUTURE DEVELOPMENTS AND TRENDS

The topic of ‘‘sound’’ science and drinking water regulation is multifaceted. Alternative views and truth claims in the ‘‘marketplace’’ of ideas must be carefully evaluated when formulating regulations and regulatory policy. Disagreements over science and scientific issues are to be expected and will certainly continue. The issues and dynamics reviewed in this chapter demonstrate the difficulties faced in assessing the soundness of a particular scientific study. Typically, a spectrum of beliefs and data must be deciphered and evaluated to extract those scientific studies, facts, assumptions, and beliefs that will stand the test of time. Determining what constitutes sound science requires time to gather factual information, consideration of opposing views and alternative hypotheses, application of good cross-discipline, fair-minded, critical thinking habits and a clear objective. For informed public policy and regulatory policy discussions, context, source, presumptions, and bias in scientific studies all must be evaluated in order to determine when science is truly sound. USEPA actions and use of science under the SDWA are subject to scrutiny by the federal courts. The judiciary gives the agency much leeway and USEPA’s administrative determinations are usually upheld by the courts. Even so, the availability of judicial review provides a constant reminder to the agency to be attentive to all procedural safeguards and to carefully consider the arguments and scientific data presented by those affected by its regulations. To make effective use of the right to judicial review, two things are essential: (1) legal arguments and factual data must be presented to USEPA prior to promulgation of the final rule and (2) petitions to challenge a final rule must be filed within 45 days after the rule is published in the Federal Register. The decision to legally challenge a USEPA rule on scientific grounds must be made by carefully evaluating the potential gains if the petition is successful and the potential risks and costs if it is not. Under the SDWA, reliance on default assumptions may be problematic, or even illegal, when the best available science supports less conservative approaches for assessing risk. The ‘‘best available science’’ under the SDWA is the scientific evidence that is available at the time of a rulemaking. The possibility of contradiction based on further scientific data or peer review is not a legitimate basis for rejecting the science that currently exists. REFERENCES Ackoff, R. L., S. K. Gupta, and J. S. Minas. 1962. Scientific Method: Optimizing Applied Research Decisions. New York: Wiley.

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Beagle, R., R. Bonita, and T. Kjellstrom. 1993. Basic Epidemiology. Geneva: World Health Organization. Bendat, J. S. and A. G. Piersol. 2000. Random Data, New York: John Wiley & Sons, Inc. Best, J. 2001. Damned Lies and Statistics: Untangling Numbers from the Media, Politicians, and Activists. Berkeley: University of California Press. BNA. 2000a. EPA Asks federal court to vacate standard setting chloroform MCLG. Daily Environment Report. Bureau of National Affairs, Feb. 28. BNA. 2000b. Industry wants court to issue opinion—chloroform. Daily Environment Report. Bureau of National Affairs, March 10. Brignell, J. 2000. Sorry, Wrong Number! The Abuse of Measurement. Broughton, UK: J. E. Brignell and the European Science and Environment Forum. Court of Appeals. 1984. Information Pamphlet Regarding Oral Argument Procedures. U.S. District Court of Appeals, D.C. Circuit, Washington, DC. Court of Appeals. 1992. International Fabricare Institute for Itself and on Behalf of its Members v. USEPA. U.S. District Court of Appeals for the District of Columbia, Case 91-1838 (Dec. 6, 1994). Court of Appeals. 2000. Chlorine Chemistry Council and Chemical Manufacturers Association v. EPA. U.S. Court of Appeals, District of Columbia Circuit, Case 99-1627 (March 31, 2000). Davies, P. 1992. The Mind of God: The Scientific Basis for a Rational World. New York: Simon & Schuster. Dougherty, C. C. 1996. USEPA Memorandum Regarding OGWDW Reorganization, April 11. Washington, DC: Office of Ground Water and Drinking Water. Einstein, A. 1990. The World as I See It: Out of My Later Years. New York: Quality Paperback Books. Feynman. R. 1989. Cargo Cult Science. Surely You’re Joking, Mr. Feynman: Adventures of a Curious Character. New York: Bantam. Hill, A. B. 1965. The environment and disease: association or causation? Proc. Roy. Soc. Med. 58:295–300. Huff, D. and I. Geis. 1993. How to Lie with Statistics. New York: W. W. Norton and Company. Inside Washington Publishers. 1998. Political pressure may result in ‘‘zero’’ standard for chloroform. Risk Policy Report 5(11):8–9. Klaassen, C. D., ed. 2001. Casarett & Doull’s Toxicology: The Basic Science of Poisons. New York: McGraw-Hill. Kneller, G. F. 1978. Science as a Human Endeavor. New York: Columbia Univ. Press. Lastrucci, C. L. 1963. The Scientific Approach; Basic Principles of the Scientific Method. Cambridge, MA: Schenkman. Lutz, W. 1989. Doublespeak. New York: Harper & Row. Lyotard, J.-F. 1997. The Postmodern Condition: A Report on Knowledge, trans. (from French) G. Bennington and B. Massumi. Minneapolis: Univ. Minnesota Press. Milloy, S. J. 2001. Junk Science Judo. Washington, DC: Cato Institute. Mintz, B. W. and N. G. Miller. 1991. A Guide to Federal Agency Rulemaking, 2nd ed. Washington, DC: Administrative Conference of the United States. Murray, D., J. Schwartz and S. R. Lichter. 2001. It Ain’t Necessarily So. Lanham, MD: Rowman and Littlefield.

REFERENCES

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NRC. 1995. Classifying Drinking Water Contaminants for Regulatory Consideration. Washington, DC: National Academy Press. NRC. 1999. Setting Priorities for Drinking Water Contaminants. Washington, DC: National Academy Press. O’Connor, D. R. 2002. Report of the Walkerton Inquiry: The Events of May 2000 and Related Issues. Toronto: Ontario Ministry of the Attorney General. Paul, R., and L. Elder. 2001. Critical Thinking. Upper Saddle River, NJ: Prentice Hall. Pickering, A. 1992. From science as knowledge to science as practice. In Science as Practice and Culture. A. Pickering, ed. Chicago: Univ. Chicago Press. Planck, M. 1932. Where is Science Going? New York: Norton. Pontius, F. W. 2000. Chloroform: Science, policy, and politics. J. Am. Water Works Assoc. 92:12. Prillaman, J. and K. Rubin. 1992. Safe Drinking Water Act. Environmental Law Practice Guide. New York: Matthew Bender. Quill, T. F. and D. B. Fischer. 2000. D.C. Circuit elevates science over politics in its chloroform decision. Risk Policy Rept. 7:12:36–38. Rothman, K. J. 1998. Causal inference in epidemiology. In Modern Epidemiology, 2nd ed. K. J. Rothman and S. Greenland, eds. Philadelphia: Lippincott Williams & Wilkins. Shermer, M. 2002. Why People Believe Weird Things: Pseudoscience, Superstition, and Other Confusions of Our Time. New York: H. Holt. Taylor, C. A. 1996. Defining Science: A Rhetoric of Demarcation. Madison: Univ. Wisconsin Press. USEPA. 1998. Science Policy Council Peer Review Handbook. EPA 100-B-98-00. Washington, DC: Office of Research and Development. USGAO. 1999. Federal Research: Peer Review Practices at Federal Science Agencies Vary. GAO=RCED-99-99. Washington, DC: U.S. General Accounting Office. Wildavsky, A. 1995. But Is It True? A Citizen’s Guide to Environmental Health and Safety Issues. Cambridge, MA: Harvard Univ. Press. Wynn, C. M. and A. W. Wiggins. 2001. Quantum Leaps in the Wrong Direction. Washington, DC: Joseph Henry Press. Ziman, J. 2000. Real Science: What It Is, and What It Means. Cambridge, UK: Cambridge Univ. Press.

10 BENEFIT-COST ANALYSIS AND DRINKING WATER REGULATION ROBERT S. RAUCHER, Ph.D. Executive Vice President, Stratus Consulting Inc., Boulder, Colorado

10.1

INTRODUCTION

The Safe Drinking Water Act (SDWA) as amended in 1996 requires that the U.S. Environmental Protection Agency (USEPA) consider benefits and costs when setting drinking water regulations. The USEPA Administrator is required to issue a formal ‘‘determination’’ that the benefits of each standard ‘‘justify’’ the costs. Further, the Administrator is authorized to set maximum contaminant levels (MCLs) at levels less stringent than what is technologically feasible if the benefits are found not to justify the costs. Although the term ‘‘justify’’ is not defined in the statute, the objective under standard economic principles is to identify the MCL at which the benefits exceed the costs by the widest margin—the point where the ‘‘net benefits’’ are the greatest. This chapter provides an overview of the methodology and criteria used for evaluating the benefits and costs of drinking water regulations. Key questions addressed are 1. How are benefits and costs assessed? In other words, how are the estimates derived, and how reliable or controversial are they likely to be? 2. How should benefits be compared to costs? This question raises issues related to how one should interpret a benefit-cost comparison in setting a public health-oriented regulatory level, and includes the issue of how nonquantifiable benefits and costs should be considered. Drinking Water Regulation and Health, Edited by Frederick W. Pontius. ISBN 0-471-41554-5 # 2003 John Wiley & Sons, Inc.

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Neither of these questions can be answered with simple responses, because many complex factors and uncertainties must be considered. Nonetheless, this chapter examines the conceptual foundation and key principles for how benefit-cost analysis (BCA) should be performed and interpreted for setting MCLs. It is intended to provide readers with a clear overview of the issues and techniques, and an understanding of the key points of contention in the debates about how BCA should be conducted and interpreted for setting standards.

10.2

BENEFIT-COST ANALYSIS (BCA) UNDER THE SDWA

Common sense suggests that the benefits and costs of various options should be considered (in some manner) when making regulatory policy or other decisions that are aimed at protecting public health. Before the 1996 Amendments, however, standard setting under the SDWA could not take into consideration what the quantified health benefits of a regulation might be, or how those benefits compared to costs. Instead, the statute prior to 1996 required that the USEPA establish technologybased standards in which the MCLs were to be set as close to the ‘‘risk free’’ levels (MCL goal) as ‘‘feasible,’’ where feasibility pertained to technologically achievable contaminant removals and practical limits of quantitation. Public health risk reduction benefits were typically examined, but these benefits were rarely quantified in any meaningful or systematic manner, nor could they be taken into account in standard setting. Under the 1996 amendments to the SDWA, new statutory language (1) required USEPA to conduct and publish of a benefit-cost analysis with every rulemaking effort and (2) enabled the Agency to use benefit-cost information in selecting how stringently to set the standard. These two features are noteworthy, especially the latter provision, which enables the Administrator to set enforceable standards that may be less stringent than what is deemed technically feasible, if the BCA indicates the less stringent MCL is justified. More specifically, the 1996 amendments now require that USEPA publish a report describing the public health risk reduction benefits and national compliance costs for every standard that it proposes or promulgates. The SDWA [Sec. 1412 (b)(3)(C)] requires that the mandated benefit-cost analysis, which is referred to as a health risk reduction and cost analysis (HRRCA), include the following:
Quantifiable and nonquantifiable health risk reduction benefits from reductions in the contaminant of concern
Quantifiable and nonquantifiable health risk reduction benefits from reductions in co-occurring contaminants
Quantifiable and nonquantifiable costs, including monitoring, treatment, and other costs
Incremental costs and benefits associated with each alternative MCL

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The effects of the contaminant on the general population and on sensitive subpopulations
Any increased health risk that may occur
Other relevant factors, including the quality and extent of information, the uncertainties in the analysis, and factors related to the degree and nature of the risk In other words, the SDWA now requires that USEPA conduct a benefit-cost analysis (viz., HRRCA) that contains both quantitative and nonquantitative information, compares incremental benefits to incremental costs, and indicates the presence and impacts of uncertainties in the analysis. The HRRCA must be available for public review and comment as part of every rulemaking action. On the basis of the HRRCA, the Administrator is required to issue a formal ‘‘determination’’ that the benefits of each standard ‘‘justify’’ the costs. Further, the Administrator is authorized to set MCLs at levels other than what is technologically feasible if the benefits are found not to ‘‘justify’’ the costs. In other words, the Amendments enable the Administrator to set the standard ‘‘that maximizes health risk reduction benefits at a cost that is justified by the benefits.’’ Hence, statutory requirements now formally mandate that public health risk reduction benefits be systematically estimated, communicated to decision-makers and the public, and then evaluated vis-a-vis costs in making regulatory decisions. It is worth noting that neither the statutory language or the legislative history specify what ‘‘justify’’ means, leaving the term open to interpretation.

10.3

HISTORICAL APPLICATION OF BCA

Since the dawn of time, humans have weighed the pros and cons of their options before acting. As a formal policy evaluation tool, however, benefit-cost analysis was spawned by language in the Flood Control Act of 1936, which mandated its use by the U.S. Army Corps of Engineers in evaluating water resource projects. The concepts underlying BCA are well grounded in economic theory, but early applications were generally unsophisticated and often politically skewed to promoting specific water projects. Over subsequent decades, the BCA maturation process has refined its conceptual foundation, empirical methodologies, and policy interpretations. Nonetheless, widely recognized limitations remain. In the environmental, health, and safety areas in particular, significant challenges to the application of BCA include uncertainties, gaps in the available data, controversies surrounding methods for quantifying physical effects or placing monetary values on nonmarket outcomes (such as change in risks to health), and issues of equity. These unresolved issues suggest that BCA should not be used as a strict decision rule for defining which policy options can be considered and that must be selected. Rather, with better use of sound scientific and policy approaches to address uncertainties and other problems, BCA can be used, as now intended under the

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amended SDWA, as a practical, objective, and valuable tool that contributes to a more informed decisionmaking process. Over the past few decades, BCA has been applied successfully and constructively to several important public health, safety, and environmental issues. For example, USEPA conducted an outstanding BCA of lead exposures from vehicle exhaust associated with use of leaded fuels. This BCA was instrumental in accelerating the phasedown of lead concentrations in motor fuels (absent the BCA, society would have continued to bear the costs of higher lead exposures). Useful benefit-cost applications to drinking water issues include a study that demonstrated that the pre-1996 SDWA statutory requirement that USEPA regulate 25 additional contaminants every 3 years was diverting scarce resources away from addressing more critical drinking water health risks. The analysis showed that some regulations cost over $1 billion for each cancer case avoided, whereas MCLs for other contaminants could achieve the same level of protection at less than $1 million per case avoided. As a consequence, close to 99% of the regulatory program’s carcinogenic risk reductions could be achieved at approximately 60% of the cost if there were greater flexibility in selecting which contaminants to regulate. Stated in another manner, the same monetary investment could have yielded far greater public health benefits if the regulations had been established on a benefit-cost basis (Raucher et al. 1994). These and other applications illustrate that, when pursued with due care (1) practical solutions to the inherent limitations of BCA can be found; (2) BCA can be a feasible, objective, and valuable tool for decisionmakers; and (3) BCA can be used to promote as well as criticize environmental programs (i.e., it is not a device intended solely to undermine the fabric of the nation’s health, safety, and environmental regulations). The balance of this chapter discusses issues related to how BCA should be conducted and interpreted to best ensure that the nation’s investments in drinking water yield the greatest public health benefits possible.

10.4

USEPA POLICIES AND PRACTICES

Before the 1996 Amendments to the SDWA, USEPA was not allowed to consider BCA issues in setting MCLs, nor was it required under the statute to estimate benefits. Nonetheless, since 1981 a series of Executive Orders—coupled with regulatory reviews by the Office of Management and Budget (OMB)—required that the Agency make some attempts at estimating benefits and comparing them to costs. Typically, these pre-1996 BCAs were very simple and qualitative, relying on very general information such as listing the potential adverse health effects associated with a contaminant of interest, and in some instances indicating the number of water systems and people possibly exposed to levels of regulatory interest. One key exception was the MCL for lead, for which a fairly extensive benefits analysis was developed, consisting of health risk assessments and economic valuations for many types of adverse health effects that were likely to be reduced by the rule. The BCA for this rulemaking was similar to some of the better analyses that the

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Agency had conducted in its nondrinking water programs. For example, between 1981 and 1996, some reasonably sophisticated BCAs had been conducted by USEPA in the context of some of its air quality and wastewater regulatory activities. With passage of the 1996 Amendments to the SDWA, the USEPA drinking water program has attempted to step forward with better BCAs. For example, a benefits workgroup was convened as part of National Drinking Water Advisory Council (NDWAC) activities, and this panel established several guiding principles for using BCA in a manner consistent with good economic theory and public policy. In addition, USEPA’s analyses for SDWA-related rulemakings issued since 1996 have provided more quantitative and comprehensive BCAs than were typically seen before the Amendments. Nonetheless, some post-1996 BCAs (e.g., for MCLs more recently proposed or promulgated, such as for disinfection byproducts, radon, and arsenic) have raised concerns amongst some reviewers and stakeholders regarding shortcomings in how benefits were estimated and portrayed, how benefits were compared to costs, and how the Agency interpreted the BCAs. On a broader level (i.e., beyond the drinking water program), USEPA has been revisiting key BCA issues. The USEPA Office of the Administrator has published Guidelines for Preparing Economic Analyses (USEPA 2000) that address the core issues of how to conduct a BCA. In addition, the Agency’s Science Advisory Board (SAB), Environmental Economics Advisory Committee (EEAC), issued a report on the key issues of how USEPA should assign monetary values to regulations that reduce the risk of premature fatality (June 2000). Both reports provide practical and sound guidance on how BCAs should be conducted, but to date the HRRCAs from the USEPA’s drinking water office have not fully adhered to the spirit or letter of the guidance.

10.5

COMPARING BENEFITS TO COSTS

The goal of a BCA should be to help guide decisionmaking toward options that lead to the highest level of well-being for society as a whole (economists refer to this as ‘‘maximizing social welfare’’). This means looking for the MCL at which the benefits exceed the costs by the widest margin.

10.5.1

Maximizing Net Benefits

The point at which the benefits of an MCL exceed the costs by the widest margin occurs where the ‘‘net benefits’’ are the greatest. Net benefits equals the benefits minus costs. Sometimes the ratio of benefits to costs (B=C) is used as a way to evaluate a policy. If the B=C ratio is greater than 1, then the benefits outweigh costs. The use of a B=C ratio is valid for considering alternative investments, because the option yielding the greatest rate of return (highest B=C ratio) can be identified. However, for regulatory policy decisions such as setting an MCL, the net benefits concept (benefits minus costs) is more appropriate rather than the B=C ratio. This is

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because the objective is to identify the MCL that maximizes social welfare (net benefits), and not to develop an investment strategy that maximizes rates of return. To identify the MCL that yields the greatest net benefit, economists look for the point where marginal benefits are equal to marginal costs. These ‘‘marginal’’ concepts refer to the change in benefits and the change in costs for each possible increased stringency of an MCL (i.e., what the additional benefits and costs would be if an MCL were to be made 1 mg=L more stringent than the last option considered).

10.5.2

Incremental Benefits and Costs

In reality, there are rarely data to examine how marginal benefits and costs change at such a tiny (i.e., 1 mg=L) change in an MCL, so instead the terms incremental benefits and incremental costs are used instead of marginal benefits or marginal costs. These ‘‘incremental’’ terms refer to examining how benefits and costs change from one MCL option to the next (e.g., moving from a 50 mg=L arsenic standard to a 20-mg=L MCL option, and then examining the incremental benefits and costs of moving from 20 mg=L to 10 mg=L, and so forth). The incremental perspective allows one to view regulatory options one step at a time, and to identify the point (MCL option) at which moving to the next, more stringent option would add more costs than benefits (where incremental benefits become outweighed by incremental costs). By selecting the lowest MCL for which the incremental benefits still outweigh the incremental costs, the policy will yield the greatest possible net benefits to society. This is why the SDWA statute now specifies that the HRRCA reveal the incremental costs and incremental benefits of each MCL option—it is the comparison of these incremental benefits and costs that enables one to maximize social welfare. This concept of maximizing net benefits by comparing incremental benefits to incremental costs is also how most economists would interpret the intent of the SDWA BCA provisions. One limitation of some drinking water BCAs to date has been the omission of an incremental benefit-cost comparison. Instead, some BCAs have shown total benefits and total costs, and justify MCL selections on the basis of the assumption that benefits are roughly the same size as costs. This type of benefit-cost comparison only indicates that the regulation may be a ‘‘breakeven’’ proposition at best (net benefits of zero)—there has not been any attempt to consider using the analysis to maximize net benefits, only to show that net benefits may be positive. Tables 10.1 and 10.2 illustrate the distinction between a total and an incremental BCA perspective, drawing on an analysis of hypothetical MCL options for MTBE (Raucher et al. 2002). Table 10.1 reveals the total (or average) benefits for each MCL option, and compares them to the hypothetical total cost estimates for each MCL. For each MCL option, the total benefits outweigh the total hypothetical costs. If one were choosing the MCL solely on the basis of the criterion that net social benefits (benefits minus costs) are positive, then any of the MCL options would pass the test. If a 10-mg=L standard were technically feasible, the depicted comparison of total benefits to total costs would ‘‘justify’’ that option.

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TABLE 10.1 Total Benefits and Costs for Hypothetical MTBE Examplea Regulatory Scenario

Total Average Benefits ($)

Total Costs (Hypothetical) ($)

Net Average Benefits ($)

192 230 273

15 75 195

177 155 78

MCL ¼ 20 mg=L MCL ¼ 14 mg=L MCL ¼ 10 mg=L

a All values are expressed in 1999 dollars rounded to the nearest million. Total costs are based on a hypothetical example. Results are for fatal cancers only and assume a linear dose–response model and low-end hypothetical costs, and use the mean values from the benefits distribution.

Source: Raucher et al. (2002).

A more relevant and informative comparison would examine the incremental benefit and cost estimates. This is shown in Table 10.2, in which the total amounts from Table 10.1 are converted to their incremental counterparts (using simple subtraction). This incremental comparison tells a story different from that of the preceding one—namely, that the first regulatory increment (baseline to 20 mg=L) provides expected net improvements to welfare, but that the more stringent options each add more in costs than they add in benefits. This reveals the value of the incremental perspective, because it identifies that going from 20 to 14 mg=L would cost more to society than it would pay back in benefits—the more stringent options creates a net loss in social welfare relative to the 20-mg=L option.

10.5.3

Accounting for System Size

An additional point to consider in comparing benefits and costs is the need to break the analysis down by system size category. This is because drinking water treatment costs (the costs of compliance) tend to be relatively high on a per unit basis in small (rural) systems. Therefore, households served by small and=or rural water systems TABLE 10.2

Incremental Benefits and Costs for Hypothetical MTBE Examplea

Regulatory Scenario Baseline to MCL ¼ 20 MCL ¼ 20 to MCL ¼ 14 MCL ¼ 14 to MCL ¼ 10 a

Incremental Mean Benefits ð$Þ

Incremental Costs (Hypothetical) ð$Þ

Incremental Net Benefits ð$Þ

192 38 43

15 60 120

177 (22) (77)

All values are expressed in 1999 dollars rounded to the nearest million. Cost estimates are based on a hypothetical example. The results assume a linear dose–response model and low-end hypothetical costs, and use the mean values from the benefits distribution. Fatal cancers only. Source: Raucher et al. (2002).

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typically bear a disproportionately high share of the regulatory costs relative to customers in larger systems that enjoy economies of scale in treatment. While a uniform MCL for small and large systems does provide households with roughly ‘‘equal health protection’’ in terms of exposure, regardless of where they live or the size of the community water system (CWS) that serves them, the cost burden that each bears can be significantly different. In essence, any given MCL is likely to impose much higher costs per unit of risk reduction benefit received by households served in small systems relative to the costs per risk reduction borne in larger communities. This raises a fundamental issue of fairness—should families served by small systems be forced through regulations to pay much higher costs for their risk reduction benefits than do households in larger, more urban settings? When BCA results are cast solely on the basis of national aggregates of benefits and costs, small system benefit-cost impacts are often obscured under the preponderant share of total costs and benefits borne by larger systems. Therefore, BCA results should also be made available on a system size basis, so that the benefit-cost tradeoffs borne by small system customers can be readily evaluated. These may reveal that the cost per unit of risk reduction (e.g., the cost per cancer fatality avoided) may be unreasonably large for households served by small systems. This type of finding can then be used as a basis for considering alternative MCLs, for considering providing supportive compliance funding to small systems, or both. For example, using USEPA’s results for the proposed radon rule, it is evident that the largest impact in terms of systems bearing compliance costs will be in the smallest size categories. These small CWS bear a disproportionate share of the costs, due predominantly to economies of scale in radon removal treatment technologies. And, because there are relatively few individuals exposed in small systems,

Figure 10.1 Percent of CWSs impacted by the proposed radon MCL [source: derived by Stratus Consulting Inc. from USEPA HRRCA (USEPA 1999)].

10.6 MEASURES OF RISK REDUCTION BENEFITS

233

the benefits tend to be disproportionately low. Figure 10.1 reveals the percentages of national costs and benefits borne by CWS according to size categories (populations served), as derived by USEPA in the HRRCA (USEPA 1999). In the two smallest size categories (systems serving between 25 and 500 persons), the customers will bear over 40% of the total nationwide compliance costs, yet realize only 5% of the national benefits. Hence, even if the benefits were roughly equal to costs at the national level, the small system residents would nonetheless be paying a disproportionately high cost per unit of risk reduction relative to their large system counterparts. The issue of environmental justice for small system customers is especially critical when considering how many of the regulation-impacted systems are in the small system size categories. In Figure 10.1, a line is superimposed on the benefitcost shares to indicate the percentage of CWS that will be impacted by the rule. Approximately 37% of the systems affected by the rule are in the smallest size category, bearing 17% of the nation’s compliance costs, but receiving only 1% (or less) of the benefits. When aggregating up to somewhat larger systems, an estimated 75% of the systems directly incurring compliance costs at an MCL of 300 pCi=L are in the two smallest size categories; and 94% of the regulation-impacted CWSs are in the three smallest size categories. Equity concerns need to be taken into explicit consideration when 94% of the impacted systems accrue only about 20% of the national benefits, but bear over 60% of the nation’s compliance costs.

10.6

MEASURES OF RISK REDUCTION BENEFITS

Drinking water regulations generate benefits that are in the form of reduced risks that exposed people will suffer adverse health impacts. In other words, the benefits are thought of as a reduced number of illnesses (morbidity) or deaths (mortality). This raises the question of how one predicts the number of such adverse health effects avoided, and also how one places a dollar value on ‘‘saving lives’’ or ‘‘protecting good health.’’ In other words, the key issues that arise are (1) how to quantify the benefits and (2) how (or whether) to assign monetary values to these benefits, so that benefits can be compared directly to costs. 10.6.1

Quantifying Risk Reduction Benefits

Drinking water regulatory benefits typically are quantified in terms of the number of illnesses or premature fatalities avoided as a result of reducing exposures to contaminants. As such, the quantified estimates are based on a series of analyses that constitute a ‘‘risk assessment.’’ These start with contaminant occurrence (How many systems have this contaminant, and at what concentrations?), exposure assessment (Given a concentration in drinking water, how much does the person actually ingest—what is their ‘‘dose?’’), and dose–response (What level of health risk is associated with the estimated level of exposure or dose?).

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Ultimately, the risk is characterized in some quantitative fashion (to the degree feasible), such as the excess lifetime risk of cancer for a person exposed to a given concentration for a specified duration of time. For example, there may be a 1.0  106 lifetime risk (i.e., a one in a million chance) that someone exposed to contaminant X at a concentration of 10 mg=L would suffer a cancer as a consequence. This result implies that for every million people exposed at this level, there would be one expected excess case of cancer in that population due to the presence of that compound in drinking water. Such results typically are based on several key assumptions, such as having the person consume 2 L of water per day in a 70þ year lifetime of exposure. Whether underlying assumptions are reasonable or representative is often a point of contention between USEPA and stakeholders. Using the preceding example, if a regulation eliminated this risk 106 entirely for one million people, then the benefits would typically be quantified as one cancer case avoided per lifetime (or 0.014 cancers avoided per year, using the typical but questionable assumption that the risk is spread equally over a 70-year lifetime). If the type of cancer is predominantly fatal (low survival=remission rate), then one might portray the result as one life saved. Technically, the 5-year survival rate for a cancer should be used to split the estimated number of cases into those that probably would be fatal and those that would be nonfatal (but serious) health effects. While ‘‘lives saved’’ is a convenient and readily understood metric, it is important to recognize several important facts: 1. There is no identifiable individual whose life is saved. Instead, the outcome reflects what is referred to as a ‘‘statistical life’’ because what the regulation has really accomplished is to reduce a low-level risk that was borne across a large population. In effect, the MCL reduced the risk levels borne by 1 million people, and the estimate of one ‘‘life saved’’ is just a convenient metric for portraying that risk reduction. 2. Because every person is mortal, no regulatory action truly ‘‘saves lives.’’ Instead, MCLs may reduce a number of ‘‘premature fatalities’’ or, put another way, ‘‘increase the life expectancy’’ of someone who might otherwise have suffered a fatal illness. For example, by avoiding a fatal cancer that typically strikes late in life, a rule may add 10–20 years of life expectancy of every predicted statistical life saved. This is typical of lung cancer and bladder cancer, where the typical age of onset is in the mid-60s and mid-70s, respectively. If the typical life expectancy for someone spared one of these cancers would otherwise be 85 years, then each fatal cancer case avoided yields a benefit of 10–20 ‘‘life years saved’’ (LYS). Alternatively, if the fatal cancer avoided was a childhood leukemia, then the expected benefit would be closer to 70–80 LYS per case avoided. Thus, the LYS metric is a useful to way to portray and compare benefits.

10.6.2

Quality-Adjusted Life Years

Quality-adjusted life years (QALYs) provide a measure of composite (or overall) risk, taking into account multiple effects that might be produced by a substance or

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mixture. The QALY approach starts with a LYS calculation, and then assigns subjective weights to each remaining year of life expectancy to reflect the quality of life under the health state projected for each year; that is, the QALY approach calculates the excess probability of death from a substance and converts it to years of life lost. These years lost are subtracted from the mean lifespan in the population. The remaining years of life are multiplied by a fraction that represents the ‘‘desirability’’ of life under the conditions of chronic, nonfatal, effects produced by the substance. The weights are assigned within the range of zero to one, with a higher score reflecting a higher anticipated quality of life. In essence, the LYS approach is a simplified QALY application, with each year given an equal weight of one regardless of projected health status during that year. In QALY approaches, each health effect contributes in one of two ways: (1) it can adjust the lifespan, decreasing it through premature death, or (2) it can reduce the quality of the remaining years of life. The result is a single number characterizing the equivalent number of effect-free years of life left to an individual as a result of exposures. A lower QALY value represents a greater individual risk of lower health-related well-being (in economic parlance, a lower utility for the individual). The lower the product of the mean QALY and the size of the impacted population, the greater the welfare loss for the population. The QALY approach has been suggested by OMB as a useful way for federal agencies to portray benefits. Although the QALY approach to developing a composite measure of risk is feasible and has been widely applied in the health care field, it remains highly controversial because of conceptual and empirical hurdles. The most notable drawback is the subjectivity in having analysts determine the appropriate measure of ‘‘desirability’’ for a year of life characterized by the presence of a specific, nonfatal, effect. The weights assigned to the desirability of a given year and health status are subjectively assigned by experts, and do not reflect any systematic revealed or stated preference elicited from the affected public. On the other hand, proponents of the QALY approach stress the desirability of having a single metric that can be applied to a wide range of possible changes in health states, including both cancer and noncancer effects. Advocates also point out that while the weights assigned may be subjective, they may be less arbitrary and more informative than the LYS approach, in which each year of longevity gained or lost is assigned an equally value (of one). 10.6.3

Valuing Risk Reduction Benefits

Once the change in risk of adverse health effects has been estimated (e.g., 10 excess statistical cancer fatalities would be avoided annually), a range of valuation techniques can be applied to estimate benefits. The two common measures of monetary value for human health are cost of illness (COI) and willingness to pay (WTP). Assigning monetary values to quantified changes in health risks raises numerous normative and positive issues. For example, some arguments have been aired that life is ‘‘priceless’’ and that public health and environmental policies should not be subject to benefit-cost analyses. However, regardless of how one philosophically views the issue of assigning monetary values to changes in health status, sound

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policy development requires that such a step be taken. At a minimum, an implicit valuation of changes in health risk should be performed, such as in a cost-effectiveness context of the ‘‘cost per change in health risk.’’ 10.6.4

Willingness to Pay: The Value of a Statistical Life

An important observation helps define how to address the thorny ethical, conceptual, and empirical issues associated with ‘‘valuing good health’’ or ‘‘placing a dollar value on lives saved.’’ The key is to recall that MCLs reduce risks, they do not ‘‘save lives’’ or ‘‘improve health’’ per se. Therefore, the key to valuation is to examine how people respond to and reveal their values (or preferences) about risks. Every day, people face a wide range of risks to their health and safety. Some of these risks are borne involuntarily (e.g., exposure to pollutants, or a genetic predisposition to certain types of disease); some risks are confronted by choice (e.g., choosing whether to use tobacco, install smoke detectors, wear a seat belt, ride a motorcycle, or accept a job in a risky occupation). By observing how individuals make choices about the level and types of risks they bear, and the level of cost they incur to reduce risks (or the rewards they receive when accepting increased risks), economists have been able to make clear inferences about the monetary worth people place on risk reductions. There are over 26 published research papers in which economists have developed estimates of the ‘‘value of a statistical life’’ (VSL) by looking at how people state or reveal their willingness to pay (or to accept compensation) for lower (or elevated) risks. Typical studies examine wage rate premiums in risky professions, or consumer behavior in purchasing risk-reducing items. Willingness-to-pay estimates represent monetary measures of the value individuals place on the change in quality of life achieved as a result of a risk reduction. The WTP-based measures are the conceptually appropriate approach, in accordance with well-established and broadly accepted principles of welfare economics. USEPA has reviewed the WTP literature and found a midrange value for VSL of $6.1 million (in 1999 dollars), and the range spans roughly from $1 million to $20 million (USEPA 1997). This USEPA finding is generally accepted as a reasonable interpretation of the literature, although there are important controversial issues how the VSL estimate should be adjusted when applied to drinking water standards (as discussed in several sections below). The VSL concept is suitable for application to MCLs (or other environmental, public health, or safety programs) because the value concept corresponds to the risk reduction context—MCLs reduce low level risks across a large population, and the VSL estimates reflect how people value small changes in low level risks that also are spread across a large population. For example, a VSL estimate may be based on a $610=year wage premium per worker in an occupation where the risk of fatal accident is 1 in 10,000 per year. This means that for every 10,000 exposed workers, one statistical premature fatality is expected each year. Collectively, these workers enjoy a combined wage premium of $6.1 million annually ($610 times 10,000). Thus, the VSL estimate would be $6.1

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million. This is directly parallel to the risk reduction benefits of an MCL in the sense that the number of fatalities, and the overall dollar value, reflect risk-based ‘‘statistical lives’’ over a large population, and not identifiable individuals. However, other issues are important in how VSL estimates should be applied in the MCL context, such as the timing of the risks, the amount of life extension generated per case, and other attributes of the risks and the impacted populations (as addressed below).

10.6.5

Cost of Illness

Nonfatal risks (i.e., for illnesses) can be more difficult to monetize using a WTP approach than premature fatalities. The literature on WTP values for avoiding morbidity is not well developed, hence most empirical work relies instead on the COI approach. The COI approach estimates medical expenses and lost income due to premature death or illness. Categories of costs usually estimated include hospitalization, emergency room, physician costs, drug costs, the value of time spent being sick (i.e., the value of work lost as a result of illness, and the value of nonwork time spent being sick). This approach places no value on the time or the lives of those who are not in the labor market, nor does it recognize the lost utility to those who suffer pain (i.e., the lost value of being healthy). The attraction of the COI approach is that it can be used, with various modifications, for a wide range of health endpoints, including mortality and morbidity from either chronic or acute exposure. Another attraction is that it is readily understood by policymakers and the general public, and it is a relatively straightforward exercise to obtain defensible estimates of medical costs, lost wages, and so forth. USEPA has developed a report on the COI of specific adverse health endpoints (e.g., bladder cancer), and it is readily available for direct application in benefit studies (USEPA 2001). The principal weakness of the COI approach is that it underestimates the full benefits of a risk reduction. It is an ex poste measure of cost, not the conceptually appropriate ex ante measure of value. COI will understate the value that individuals place on being healthy and alive, and will understate costs for those who are not in a position to secure appropriate medical attention and those who are not part of the paid labor force. It is possible to attempt to correct for this deficiency by crudely adjusting COI estimates to reflect limited empirical evidence on the relationships between COI and WTP estimates. For example, where both types of estimates have been derived for the same health endpoint, WTP has been twice (or more) the COI estimate. Given the limitations of the COI approach, the use of COI is generally recommended only where no WTP estimates are available (e.g., for most nonfatal illnesses), and that analysts clearly identify the results as lower bound estimates of benefits (i.e., that observed costs are being used as a proxy for unobserved values). COI estimates may also be presented side by side with WTP-based estimates (e.g., for valuing changes in mortality risks) to create a lower bound or as part of a sensitivity analysis.

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BENEFITS TRANSFER TO DRINKING WATER

Benefits transfer (BT) refers to the practice of using empirical results derived from one or more primary research studies, and applying these results to another context or policy. For example, the published literature that develops estimates of VSL from data from occupational settings (based on wage–risk tradeoffs) is usually used to assign monetary values to reductions in fatal risks that accompany the setting of an MCL. The key question to consider is whether (or how) VSL estimates should be transferred to drinking water applications. BT is often used in evaluating public policies because there is rarely the time or budget necessary for conducting primary research efforts that directly apply to the policy in question. For example, it would be very time-consuming and expensive to design and conduct a credible study of the value people place on the risk reductions associated with a potential change in a specific drinking water parameter. For example, a highly credible and applicable research effort using state-of-the art survey or hedonic methods to collect and analyze data from a large sample might take more than $1 million and a year to complete. Because the use of BT is often a practical necessity, there are standard practices and procedures about how BT should be conducted and evaluated. The standards come from the peer-reviewed economics literature [e.g., see Desvousges et al. (1992)] and are embedded in some federal programs for valuing changes in environmental quality [e.g., National Oceanic and Atmospheric Administration’s regulations for natural resource damage assessment (U.S. Department of Commerce 1996)]. While the quality (scientific validity and robustness) of the various pieces of empirical VSL literature is an important matter, the large number of well-regarded studies (e.g., the 26 used in USEPA’s assessment) provides a convincing weight of evidence that the body of work provides a reasonably credible range of values. Instead, in the VSL context, the primary focus is on issues of the applicability of the estimates—which are derived predominantly from occupational and other accidental death contexts—to the issue of risks posed in by drinking water. In terms of the applicability of VSL estimates for the drinking water context, the key issues are that the VSL estimates derived from the published literature are often based on types of risk (e.g., accidental deaths in occupational settings) that affect groups of individuals (e.g., blue-collar employees in their working years) that differ from the types of risks and impacted populations that apply in a drinking water context. Thus, there is a need to consider whether the attributes of the risks and the attributes of the affected populations are similar between the original empirical research effort and the policy application (and if not, whether some adjustments might be feasible and appropriate). For example, changes in drinking-water-related risks may occur many years or decades after a regulation changes exposure levels (e.g., for carcinogens), whereas most VSL studies pertain to accidental deaths that occur immediately. The VSL studies reflect observed values for an average aged person (between the ages of 35 and 40) who might immediately lose all their remaining life expectancy (40–50

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years). In contrast, the benefits of an MCL for a carcinogen to an average aged person should reflect the values for losing perhaps 15 years of life expectancy, and that potential loss would occur perhaps 30 years in the future. There is good reason to suspect that a 38-year-old reflecting on dying 30 years from today (instead of in 45 years) would assign a lower value to reducing that risk than she or he would to dying immediately. On the other hand, some have pointed out that VSL estimates may be understated if they reflect values for people who have less than average risk aversion or below average education and incomes, and=or if people dread involuntary cancer risks more than other types of risks they can better control personally.

10.7.1

Adjusting VSL

The issues described in the preceding section illustrate why it may be misleading to apply literature-based estimates of VSL directly to the context of changes in the quality of drinking water. This raises the question of whether some adjustment to the VSL estimates may be appropriate. This section discusses the issue of whether and how such adjustments may be necessary. This question was addressed by the USEPA SAB Environmental Economics Advisory Committee (EEAC), and the approach described here draws on (and conforms with) the report issued on the topic (SAB EEAC 2000). The report recommends including latency periods for delayed onset health effects, and discounting the results to present values (using the same discount rate applied to all other benefits and costs). The SAB EEAC also recommends accounting for income growth over the relevant period, and applying a range of income elasticities to reflect the increased WTP for risk reduction that accompanies income growth. The SAB EEAC does not endorse further empirical adjustments to VSL estimates for application to environmental contexts (e.g., to reflect a potential dread factor for cancer), but does suggest conducting sensitivity analyses for potential age-based adjustments to VSLs.

10.7.2

Accounting for Latencies

To date, USEPA analyses of drinking-water-related risk reductions have used the simplifying assumption that risk reductions accrue immediately after reduction in exposure. This assumption skews the benefit analysis significantly by counting cancer cases that are avoided far into the future as cases that are avoided immediately. By assuming ‘‘immediacy’’ of benefits realization, USEPA implicitly assigns a latency period of zero years for cancer risk reductions. Although it may be true that the exact length of the latency period is variable and uncertain, it is widely recognized in the scientific community that latency periods are not zero for most carcinogens. Rather, the latency period is likely to be many years (e.g., 10, 20, or 30 or more years) for typical carcinogenic modes of action. Instead, multiyear latency scenarios

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should be used, with a range of multiyear latency scenarios applied as a mechanism to reflect the degree of uncertainty regarding the latency period. Evidence for accommodating nonzero latency periods in the benefit-cost analysis can be found by examining the age of onset for specific cancer endpoints of relevance. For example, National Cancer Institute Surveillance, Epidemiology, and End Results (SEER) Program data indicate that the mean age of onset for bladder cancer in the United States is after 71, average age at death is 77, and less than 1% of fatal cases arise in people under 45 (less than 5% of the cases occur in people under 55, and 15% in people under 65) (NCI 1998). This type of readily available information can be used, in concert with sound scientific evidence, to develop plausible latency period scenarios for the analysis. 10.7.3

Discounting Costs and Benefits

Introducing scientifically justified latency period scenarios for cancer cases avoided in turn raises the important issue of discounting the future health effects avoided by the proposed regulation. Basic economic welfare theory is quite clear about the appropriateness of discounting future benefits and costs, and the need to treat future benefits and costs in a consistent manner (i.e., applying the same discount rate to all benefits and costs). The SAB EEAC fully agreed with this principle, and stated that future cancer fatalities need to be valued by taking the latency periods into account and discounting the associated VSL estimates back to present value, using the same discount rate as applied to all other costs and benefits (SAB EEAC 2000). There may be some exceptions to this principle in cases where intergenerational equity impacts are under consideration, but this is not the case for most drinking water quality issues. Risk reductions associated with changes in water quality are realized by the same generation of individuals for whom exposures are reduced via the costs incurred (e.g., for additional treatment). OMB has issued guidance on discounting based on a review of the economics literature, and requires that federal agencies discount costs and benefits at a real rate of 7% (OMB 1992). Under the OMB guidance, other discount rates can also be applied in the form of sensitivity analyses, if accompanied by suitable justification. As one alternative scenario, analysts may want to consider that an expert panel assembled by the U.S. Public Health Service (Gold et al. 1996) directly addressed the issue of discounting future health risk reductions, and clearly articulated that it is the conceptually appropriate approach to apply a positive discount rate to such future health risk reduction outcomes. This panel advised using 3%. For another feasible discount rate scenario, analysts should consider the empirical evidence available in the peer reviewed literature on how much people discount future fatal risks (Moore and Viscusi 1988, 1990; Cropper et al. 1994). These studies suggest that, on average, individuals actually apply a discount rate that may be considerably higher than 7% to future fatal risk reductions (e.g., empirical evidence suggests rates of 10 to 12% or higher—perhaps as high as rates charged to credit card balances).

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10.7.4 Adjusted VSLs to Reflect Latency, Discounting, and Income Growth As noted above, USEPA has been using $6.1 million (1999 U.S. dollars) as the most likely benefits value for each premature fatality avoided, based on the mean estimate the Agency developed from its review of the VSL literature. The $6.1 million estimate does not reflect the latency, discounting, or other factors that would affect this valuation. Such adjustments can be made in accordance with the SAB EEAC report (SAB EEAC 2000). The SAB report states that two adjustments should be made to the VSL estimates: (1) latency and discounting need to be factored into the estimate, as noted above, and (2) VSLs should be adjusted to reflect the impact that projected real income growth might have on the VSLs of future (wealthier) Americans. Age-adjusted VSLs are also suggested by the SAB, but in the form of a sensitivity analysis. In an AWWA Research Foundation (AWWARF) project examining this issue (Raucher et al. 2002), the research team developed Monte Carlo simulations to make both sets of SAB-recommended adjustments, using the USEPA’s Weibull distribution with an estimated mean of $6.1 million for the unadjusted VSL as the starting point. The distribution of adjusted VSL estimates is then developed by applying a Monte Carlo simulation that draws a latency period at random from a uniform distribution, bounded by 10 and 30 years. For each latency period, future income-adjusted VSLs are generated based on estimates of real income growth over that period (U.S. Bureau of Economic Analysis 2000), and then an income elasticity drawn at random from the values recommended by SAB (income elasticities of 0.08, 0.4, and 1.0). Elasticities here refer to the percent change in VSL per percent change in income. Hammitt (2000) suggests that VSL is not very sensitive to income, noting that ‘‘typical estimates suggest that a 1% change in income yields less than a 1% change in VSL—often 0.5% or less.’’ This suggests an income elasticity of 0.5 or less. Finally, for the relevant latency period, the income-adjusted VSL is discounted back to the present value using a discount rate drawn at random from a uniform distribution, bounded by discount rates of 3% and 7%. The adjusted VSLs thus reflect latency, income growth, and discounting. Table 10.3 reveals the adjusted VSL results for three cancer endpoints, based on alternative types of adjustment. The mean value generated for the discounted latency- and income-adjusted VSL using this procedure is $2.7 million per premature fatality (1999 dollars). The median estimate is $2.1 million, and the 25th and 75th percentiles are approximately $1.3 million and $3.4 million, respectively. The standard deviation is $2.2 million. Because the simulations relied on uniform distributions, this mean estimate for discounted latency- and income-adjusted VSL corresponds to a mean discount rate of 5%, applied over a mean latency period of 20 years, with a mean income elasticity of 0.49. If the applicable latency periods tend to be longer and=or if the applicable discount rates tend to be higher, the mean adjusted VSL estimate would be lower than $2.7 million (and vice versa). But these results reveal that use of unadjusted VSL estimates can significantly overstate the benefits of MCLs (and in the case of some cancers of interest, the degree of overstatement is a factor of over 225%).

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TABLE 10.3 Adjusted VSL Estimates (Means, in Millions 1999 Dollars)

Mean EPA-derived estimate (unadjusted VSL from Weibull distribution) SAB EEAC-endorsed adjustments (latency, with income growth and discounting) Age-adjusted VSL sensitivity analysis (age, income growth, latency, discounting) Using VSLY and life years saved (age of onset, latency, discounting)

Bladder Cancer

Lung Cancer

Kidney Cancer

6.1

6.1

6.1

2.7

2.7

2.7

1.3

1.9

2.2

1.2

1.5

1.6

Source: Raucher et al. (2002).

10.8

UNCERTAINTY AND VARIABILITY

One of the largest challenges in conducting and interpreting BCAs for drinking water standards (and many other environmental and public health programs) is that many uncertainties and data gaps inevitably arise in the analysis. This is especially true for the benefits side of the analysis, but also in cost analyses as well. 10.8.1

What are Uncertainty and Variability?

The terms uncertainty and variability have distinct meanings in risk assessment and benefit-cost analysis, and each raises its own issues and can be addressed in different manners. Uncertainty refers to a lack of knowledge, reflecting a gap or unknown in the applicable field of science. A classic uncertainty involves developing dose–response relationships for humans based on laboratory studies using rodents. Toxicologists develop data on dose–response findings from laboratory studies in which rodents are exposed for short periods to high doses of a contaminant. These high-dose experimental results in mice or rats then need to be translated into risk levels in humans who are exposed to relatively low doses in drinking water over a long time period. Because scientific knowledge is far from complete on these matters, these cross-species and high-dose–low-dose extrapolations are not fully understood. Because there are no known answers to these problems, these issues of how to develop or interpret dose–response functions for drinking water exposures reflect considerable uncertainty. Variability reflects differences that exist as a basic state of the world — it pertains to the fundamental reality that each person is different from the next person in relevant ways, and that conditions may differ from place to place or from time to time. Exposure assessments tend to have several important variabilities, including the amounts of water that different people consume (i.e., the mean level of per capita CWS tapwater consumption is approximately 1 L=day, but data suggest that roughly 10% of the population consumes more than 2 L=day).

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Other exposure-related variabilities of interest include the fact that different people will have different durations of exposure (some will reside in the same CWS for 70 years, some for only a few months), different body weights, or different activity patterns (e.g., time away at an office or school with a different water supply). Concentrations of a contaminant in their water may vary over time (e.g., as a result of seasonal variations in source water quality, changes in treatment regimes, distribution system flushing events, a customer’s use of bottled water, or in-home treatment units). Risk assessment and benefit-cost analyses need to reflect these variabilities in some fashion. For example, different people consume different amounts of tapwater on an average day; these differences or variabilities in drinking water consumption are a recognized and unavoidable fact of life. These variabilities can be observed and measured by collecting data from a sample of individuals (whereas uncertainties cannot be addressed by simply observing the world and collecting data). Analysts can thus understand and measure variability by collecting good data and using them in their studies. As data are collected, a probability distribution of values can be derived (e.g., that the mean level of tapwater consumption is approximately 1 L=day, and the 90th percentile is roughly 2 L=day).

10.8.2

Addressing Uncertainties and Variabilities

Uncertainties in components of a BCA typically are addressed through the use of standard assumptions or uncertainty factors. These assumptions and adjustment factors typically are somewhat arbitrary and are intended to be conservative (i.e., erring on the side of being overly protective), because the risk assessor’s primary duty is to determine the level that poses ‘‘zero risk.’’ For example, in determining the MCL for uranium, USEPA relied on kidney toxicity data derived from laboratory animal experiments. A ‘‘no-effect level’’ was observed in the laboratory studies of 60 mg kg1 day1. To translate this rodent-based finding to humans, Agency risk assessors applied an uncertainty factor of 100 when converting the rodent results into the human-oriented safe daily dose of 0.6 mg=kg (i.e., 60 divided by the uncertainty factor of 100). This adjusted no-effect exposure level is called the ‘‘oral reference dose’’ and reflects the dose at which no risks are anticipated in humans, including an ample safety margin. This is how uncertainty is typically addressed for noncarcinogens posing risks from chronic exposure. Variability in this application arises in translating this safe ‘‘oral reference dose’’ for humans (a dose per body weight) into a drinking water concentration (measured in micrograms per liter). Typically, risk assessors remain conservative at this stage as well, and apply a set of high-end assumptions to ensure that the most sensitive and most highly exposed persons are protected. For the uranium example, which is typical, USEPA assumes that a 70-kg person who drinks 2 L of CWS tapwater daily and obtains 80% of his or her total uranium exposure through drinking water. In reality, these standard assumptions reflect upper ends of the variability distributions rather than average or typical conditions. But they are adopted by

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risk assessors to assure safety to even highly exposed and highly sensitive persons in the overall population. On the basis of these exposure assumptions, the uranium ‘‘safe’’ oral reference dose (0.6 mg kg1 day1) is translated into a ‘‘safe concentration in drinking water’’ of 16.8 mg=L [(0.6 mg  80%)=(2 L=day  70 kg)]. The Agency then rounds to 17 mg=L and defines this as the drinking water equivalent level (DWEL) for uranium. In this typical risk assessment application for a systemic (noncarcinogenic) compound, variability is addressed through a simple set of assumptions that apply the high-end values observed from the underlying variability distributions.

10.9 PRECAUTIONARY ASSUMPTIONS VERSUS CENTRAL TENDENCIES The preceding discussion described how uncertainty and variability typically are addressed in risk assessments, wherein standard conservative assumptions are used to address both uncertainty and variability. This use of conservative assumptions and uncertainty factors is related to the ‘‘precautionary principle’’ and is suitably used in the risk assessment context to ensure that the designated ‘‘safe’’ concentration (DWEL) is indeed risk free for even the most highly sensitive and highly exposed individuals, with an ample margin of safety. Although the use of precautionary assumptions is well established and accepted in the context of a risk assessor’s mission to define a concentration that is ‘‘safe,’’ the use of these same assumptions is not suitable for a BCA. This is because the BCA should reflect the most accurate or typical conditions. In other words, the risk assessment process is designed to err on the side of safety, but the BCA is intended to reflect an evaluation of what health risk reduction benefits can be expected from a potential MCL. When conservative assumptions and adjustment factors are applied throughout a BCA, the effects become compounded, and this results in risk reduction benefits estimates that will be greatly exaggerated. For example, the chance that the persons consuming the 90th percentile volume of water per day (i.e., roughly 2 L) are also the same persons that are exposed for the 99th percentile duration (e.g., assume 70 years) is only 1 in 1000 (10.%  1.0% ¼ 0.1%), assuming that the events are statistically independent. If one used just these two conservative assumptions alone, one would have a benefit estimate that reflected the 99.9th percentile of the likely benefits distribution. Adding in uncertainty factors for the dose–response relationship would drive the results further toward extremely low probability outcomes. Several important entities have recognized the critical distinction between using the precautionary assumptions in risk assessment and using more realistic central tendencies (or whole distributions) when conducting BCAs as part of a risk management process. USEPA has acknowledged this in several recent rulemaking packages, and the U.S. General Accounting Office (USGAO) issued an excellent report on this issue as well (USGAO 2000).

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245

TABLE 10.4 Impact of Exposure-Related Assumptions on Benefit-Cost Analysis Factor

Impact Relative to Central Estimate

(a) Daily tapwater consumption (2 L=day) (b) Duration of exposure (70þ years) Occurs in 1% of systems Occurs in 5% of systems Occurs in 10% of systems (c) Combined impact in lifetime exposure estimate Occurs in 1% of systems Occurs in 5% of systems Occurs in 10% of systems

1.8

12.4 8.7 6.1 22.4 15.7 11.0

Source: Raucher (2001).

USEPA has made some efforts to use averages and plausible ranges in its most recent BCAs, especially for drinking water consumption. However, precautionary elements still persist throughout the analyses, including the use of overly conservative dose–response information and lifetime durations of exposure. This problem can be addressed using some standard methods, including simple sensitivity analyses and more elaborate probabilistic assessments (such as applying Monte Carlo techniques). An AWWARF project provides a detailed illustration of these issues (Raucher et al. 2002). Tables 10.4 and 10.5 also indicate the extent to which various precautionary assumptions can individually and collectively impact a BCA. TABLE 10.5 Impact of Cancer Risk Assessment Assumptions on Benefit-Cost Analysisa (a) Use of linear dose–response function (relative to suitable nonlinear alternative) MTBE illustration (at mean) Arsenic illustration (repair model) (b) Use of 95th upper confidence limit (relative to maximum likelihood) (c) Combined illustrative impact [if both (a) and (b) are relevant] (d) Impact when combined with exposure illustration (Table 10.4) a

12.8 3–5 2–3 6–38.4 66–860

Note that results are case-specific, depending (for example) on degree and type of nonlinearity over relevant exposure range, and difference between high-dose data points and low doses of regulatory relevance. Source: Raucher (2001).

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10.10

OMITTED OR UNQUANTIFIED BENEFITS AND COSTS

Another challenge in developing and interpreting BCAs arises when an important benefit or cost cannot be readily quantified or expressed in monetary terms. For example, the principal health risk benefit underlying the December 2000 uranium standard is kidney toxicity. The level of renal toxicity risk is highly uncertain and therefore cannot be quantified (i.e., there is no way to estimate a projected number of disease cases avoided). In such a circumstance, benefits cannot be directly compared to costs. When potentially important benefits (or costs) cannot be directly included in a quantitative BCA, the analyst has several options. An unsatisfactory option is to ignore the omitted benefits or costs, and base the decision only on those benefits and costs that can be included. This is undesirable because if important benefits are left out, then an MCL will not be set as stringently as it should. Likewise, if important costs are omitted, then the BCA would suggest an MCL that is overly stringent. Another unsatisfactory option is to use the existence of an unquantified benefit (or cost) as an excuse to set an MCL at a level that probably does not maximize net benefits. Even though an unquantified benefit may be important and should not be overlooked, it should not be used ‘‘carte blanche’’ as an excuse to set an overly stringent MCL (and vice versa, for an omitted cost). While a potentially significant unquantified (or unmonetized) cost or benefit should not be ignored, nor should it be afforded undue weight and influence. To determine how much weight should be given to considering an unquantified benefit or cost, several informative and appropriate options can be explored to try to include the omitted (nonmonetized) benefits or costs within the BCA framework in as useful and objective a manner as possible. In some cases, this will simply entail providing a good qualitative discussion of the unquantified outcome so that decisionmakers can take it into account along with the numeric BCA findings. If benefits already exceed costs, then a qualitative discussion of nonmonetized benefits only helps reinforce the obvious outcome (and the same is true if the omitted component is a cost and the monetized net benefits are already negative). Where the omitted element might alter the net benefit result (e.g., an important benefit is omitted where the monetized BCA components yield a negative net benefit), a ‘‘breakeven’’ analysis may be useful. This is a semiquantitative approach in which the analyst backcalculates from the estimated net benefit how large the value of the omitted benefit (or cost) would need to be for benefits and costs to be equal (net benefits are zero). This is sometimes referred to as ‘‘implicit valuation.’’ For example, if monetized benefits exceeded costs by $100 million, then the nonmonetized benefit would need to be worth at least $100 million for the BCA to ‘‘break even.’’ It may be quite obvious that the omitted benefit is (or is not) likely to be worth this amount of money. In the uranium example, the implicit valuation outcome for the unquantified benefit was that the ‘‘cost per person exposed’’ (but not necessarily having any adverse health effect) would have to be worth at least $100,000 for the incremental benefits to be at least as great as the incremental

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costs of the MCL. A policymaker or stakeholder can then judge whether it seems likely that such an expense is warranted.

10.11

UNCERTAIN COSTS

While most of the discussion in this chapter has been about issues and uncertainties in estimating benefits, the estimated cost of compliance can also be highly uncertain and controversial. Costs can be highly uncertain for a variety of reasons, including differences in whether or how treatment plant retrofit issues are addressed or how estimates account for difficulties or lack of economies in treatment at a small scale. Other areas that cause differences in cost estimates include how to account for the potential scarcity of skilled operators, reflect limited space and access for expanded treatment facilities (especially at decentralized wells), or consider residuals management issues associated with water treatment-generated wastestreams. Given these and other issues, it is not uncommon for cost estimates developed by some parties to be to be far lower (e.g., one-tenth the level) or higher than estimates predicted by other stakeholders. In this case, it is probably prudent to show BCA results using two alternative cost scenarios. This is a simple sensitivity analysis of how (or whether) the policy implications drawn from the BCA are altered, depending on which cost estimates are applied.

10.12

FUTURE OUTLOOK

BCA is now mandated under the SDWA, and the use of BCA enables standard setting for MCLs to move away from technical feasibility considerations alone. The BCA provisions enable policymakers to consider whether the mandated investment in compliance expenditures will produce suitable returns in the form of public health benefits. This is an important step forward. Since BCAs now play an important role in MCL determinations, it is vitally important that they be performed and interpreted properly. BCAs should adhere to established economic principles by trying to maximize net social benefits. This implies that the analyses should focus on comparing incremental benefits to incremental costs, benefits should be valued according to willingness to pay (as feasible), benefits transfer needs to be done carefully, and VSLs need to be adjusted to reflect latency periods and discounting where applicable. It also is important that uncertainties and variabilities be recognized and considered (e.g., through the use of sensitivity analyses or other, more sophisticated techniques such as Monte Carlo analysis). BCAs should be based on average or typical parameter values and not a compilation of exceedingly conservative assumptions (such as traditionally used when the precautionary principle is applied to risk assessment). Unquantified benefits and costs also need to be considered in a fair and systematic manner (and neither be ignored nor given undue weight). BCA results

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should also be portrayed according to system size, so that small system impacts can be more fully discerned. There are important uncertainties and challenges associated with applying BCA to the drinking water context. BCAs will often be inexact and must be performed and interpreted with due caution. Accordingly, BCAs generally should not be used as a strict decision rule. Nonetheless, BCA is a very useful tool for helping ensure that America’s investment in MCL compliance costs will yield suitable public health returns. When conducted and interpreted in a sound and objective manner, BCAs will be very informative in guiding the nation’s drinking water investments so that they generate the greatest public health returns possible. BCA as applied to drinking water standard setting is a new and evolving practice, and it probably will take time and debate over alternative policy interpretations before this tool becomes more fully integrated into the regulatory policy framework.

ACKNOWLEDGMENTS An earlier and more extensive version of this chapter was prepared as a ‘‘White Paper’’ with the generous support of the National Rural Water Association. All errors and omissions are those of the author.

REFERENCES Cropper, M. L., S. K. Ayded, and P. R. Portney. 1994. Preferences for lifesaving programs: How the public discounts time and age. J. Risk Uncert. 8:243–265. Desvousges, W. H., M. C. Naughton, and G.P. Parsons. 1992. Benefit transfer: Conceptual problems in estimating water quality benefits using existing studies. Water Resources Research 28(3):675–683. Gold, M. R., J. E. Siegel, L. B. Russell, and M.C. Weinstein. eds. 1996. Cost-Effectiveness in Health and Medicine. New York: Oxford Univ. Press. Hammitt, J. K. 2000. Valuing Lifesaving: Is Contingent Valuation Useful? Harvard Center for Risk Analysis. Risk in Perspective, 8(3). Moore, M. J. and W. K. Viscusi. 1988. The value of changes in life expectancy. J. Risk Uncert. 1:285–304. Moore, M. J. and W. K. Viscusi. 1990. Models for estimating discount rates for long-term health risks using labor market data. J. Risk Uncert. 3:381–401. NCI. 1998. What You Need to Know about Bladder Cancer. National Cancer Institute (http:==cancernet.nci.nih.gov=wyntk_pubs=bladder.htm; accessed July 21, 2000). OMB. 1992. Guidelines and Discount Rates for Benefit-Cost Analysis of Federal Programs. Circular A-94. Washington, DC: Office of Management and Budget (http:==www.whitehouse.gov=omb=circulars=a094=a094.html; accessed May 24, 2001). Raucher, R. 2001. Blending Science with Policy: Precautionary Assumption and Their Impact on Benefit-Cost Analyses and Drinking Water Standards. White Paper. Duncan, OK: National Rural Water Association.

REFERENCES

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Raucher, R., A. M. Dixon, J. A. Drago, and E. Trabka. 1994. Evaluating the cost-effectiveness of the federal drinking water regulatory program. J. Am. Water Works Assoc. 86(8):28–36. Raucher, R., D. Burmaster, D. Crawford-Brown, and A. Cox. 2002. Quantifying Public Health Risk Reduction Benefits. Denver: American Water Works Association Research Foundation. SAB EEAC. 2000. An SAB Report on EPA’s White Paper Valuing the Benefits of Fatal Cancer Risk Reductions. EPA-SAB-EEAC-00013. Washington, DC: U.S. Environmental Protection Agency, Science Advisory Board, Environmental Economics Advisory Committee. U.S. Bureau of Economic Analysis. 2000. Regional Accounts Data—Projections to 2045. (http:==www.bea.doc.gov=bea=regional=project=projlist.htm; accessed Aug. 30, 2000). U.S. Department of Commerce. 1996. Natural Resource Damage Assessments, Final Rule. 15 CFR Part 990. Fed. Reg. 61(4) (Jan. 5, 1996). Washington, DC: National Oceanic and Atmospheric Administration. USEPA. 1997. Benefits and Costs of the Clean Air Act 1970–1990. Report to Congress. Washington, DC: USEPA Office of Air and Radiation. USEPA. 1999. Health Risk Reduction and Cost Analysis for Radon in Drinking Water: Notice, Request for Comments, and Announcement of Stakeholder Meeting. Pre-publication copy of Federal Register Notice for Review and Public Comment. EPA-815-2-99-002. Washington, DC: U.S. Environmental Protection Agency. USEPA. 2000. Guidelines for Preparing Economic Analyses. EPA 240-R-00-003. Washington, DC: U.S. Environmental Protection Agency. USEPA. 2001. Cost of Illness Handbook. Prepared by Abt Associates, Inc. Washington, DC: USEPA Office of Pollution Prevention and Toxics (http:==www.epa. gov=opptintr=coi_handbook). USGAO. 2000. Use of Precautionary Assumptions in Health Risk Assessments and Benefits Estimates. Report to Congressional Requesters. GAO-01-55. Washington, DC: U.S. General Accounting Office.

11 PUBLIC INVOLVEMENT IN REGULATION DEVELOPMENT FREDERICK W. PONTIUS, P.E. Pontius Water Consultants, Inc., Lakewood, Colorado

11.1

INTRODUCTION

The Safe Drinking Water Act (SDWA) mandate an ambitious agenda for program implementation and issuance of drinking water regulations. Public participation in the development and implementation of the act is essential for the partnership ethic embodied in the act to be realized. To facilitate public involvement, the U.S. Environmental Protection Agency (USEPA) Office of Ground Water and Drinking Water (OGWDW) has committed to an open process of stakeholder meetings to inform and involve interested parties in various rulemakings. Since enactment of the 1996 SDWA Amendments, the number of public stakeholder meetings on various regulatory issues has increased dramatically (Fig. 11.1). Stakeholder meetings are expected to remain at a high level throughout implementation of the 1996 SDWA Amendments. This chapter reviews the mechanics and opportunities for stakeholders to become involved in the development of drinking water regulations.

11.2

WHO IS THE PUBLIC?

The concept of public participation can be misleading because the erroneous impression is given that the ‘‘public’’ is a single homogeneous, identifiable entity. In reality, however, the ‘‘public’’ is a diverse mixture of individuals, groups, and organizations, Drinking Water Regulation and Health, Edited by Frederick W. Pontius. ISBN 0-471-41554-5 # 2003 John Wiley & Sons, Inc.

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Figure 11.1 Trend in public stakeholder meetings on drinking water issues announced in the Federal Register.

each with different interests and differing points of view. The term ‘‘public’’ or ‘‘publics’’ is used here as a generic term referring broadly to groups, individuals, organizations, and entities with an interest in drinking water. ‘‘Stakeholders’’ generally refer to those people, organizations, and=or groups that are directly affected by an agency rulemaking or that have a direct interest in the outcome of a rulemaking. USEPA’s Science Advisory Board (SAB) has noted that ‘‘the definitions of the terms ‘stakeholder’ and ‘stakeholder processes’ have become highly elastic’’ (SAB 2001). These terms are used to refer to any interaction by USEPA with groups outside the agency, or even to involvement of people within the agency. ‘‘Stakeholders’’ may be experts, nonexperts, or semiexperts from government agencies, nongovernmental organizations, corporations, citizens, and other private parties. Diverse ‘‘stakeholders’’ desire to have input regarding how new USEPA drinking water regulations are fashioned. Certain procedures are necessary to ensure that all who would like to participate and provide input to the agency can participate on an equal basis, or nearly equal basis. Although mechanisms exist by which stakeholders can participate in regulation development, the influence or effect will vary, depending on the public involvement opportunities provided by USEPA and the resources available to the particular individual or organization. 11.3

OBJECTIVES DETERMINE INVOLVEMENT LEVEL

A number of mechanisms may be used by USEPA and other governmental agencies to encourage and allow public involvement. The mechanism used is determined by the agency’s objective and the degree of public involvement desired. Table 11.1 summarizes the principal opportunities and their characteristics, advantages, and limitations. Stakeholders must understand and take advantage of the various mechanisms if their efforts to shape future rules is to be effective. Providing a fair and equitable means for everyone with an interest in a regulation to have an opportunity to participate in its development is one of the purposes of the

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TABLE 11.1 Levels of Public Involvement in Regulation Development Level

Interaction

1. Stakeholder power

Stakeholders act without communicating with government agency; government agency may react

2. Shared power

Stakeholders and government agency solve problems together on equal basis Government agency asks stakeholders for meaningful input and intends to listen and act on input received but retains power to reject input Government agency asks stakeholders for limited input but would prefer not to listen at all; government agency retains power to reject stakeholder input and may have little incentive to accept it Government agency presents information and decisions to stakeholders; stakeholders listen and react Government agency acts without communicating at all with stakeholders

3. Stakeholders consult

4. Stakeholders talk

5. Government talks

6. Government power

Example Citizen investigations, public protests over government agency action or inaction, industry chooses to meet standards more or less stringent than the government’s Cooperative projects, joint problem solving, negotiated rulemaking Some advisory committees, informal meetings, ongoing dialog, some public hearings

Typical of public hearings, request for comments on some proposed rules, pro forma meetings, and advisory committees

Some public meetings, promulgated rules, press releases and government publications, some legal and enforcement actions Some investigations, some rulemakings, some legal and enforcement actions

Administrative Procedure Act (APA), which defines minimum procedural requirements for federal agency rulemakings. Public participation in programs under the SDWA, including minimum requirements and suggested program elements are defined in the Code of Federal Regulations, Title 40, Part 25 (CFR 2002). 11.4

INVOLVEMENT DURING THE RULEMAKING PROCESS

There are several points during the development of drinking water regulation whereby the public may participate and provide input to regulatory decisions (see Table 11.2). The key points are prior to rule proposal, during rule proposal, following rule proposal, and after rule promulgation.

254

Private meetings with USEPA

Comments submitted to USEPA

Event=Action

Stakeholders may submit information, comments, and requests on regulatory issues to USEPA at anytime; most effective if information or comments are presented to key agency staff within the window of time that the agency is considering the particular issue, prior to internal agency closure Private meetings of one or more groups with USEPA may be formal or informal, and may or may not involve dialog or consensus building; most effective if the issues and agenda are clearly defined, with adequate preparation and documentation by all parties involved

Characteristics

TABLE 11.2 Public Involvement Opportunities Limitations USEPA may not be able to address the issue(s) raised immediately because of timing, resource limitations, or statutory requirements

Potential for dialog or consensus may be hindered by the absence of other stakeholders; no opportunity to develop support of stakeholders not present; usually limited following rule proposal; may be difficult to arrange or not possible because of scheduling conflicts or perceived favoritism from other stakeholders

Opportunities Stakeholders need not feel constrained to approach the agency with regulatory concerns or issues; can be used to alert USEPA to new issues or problems needing attention or resolution

Opportunity to clearly present to USEPA key issues without the potential for disruption from other stakeholders; potential for dialog, exploration of alternatives and solutions, and development of consensus on possible approaches or solutions; most effective as part of an open stakeholder process prior to formal rule proposal

255

Oral testimony at a public hearing

Proposed rule comment period

The traditional opportunity for the public to present written views and supporting technical information on a proposed rule; most effective if data collection performed in advance so that comments and recommendations have the strongest technical foundation possible; comments must be submitted to the designated address by the specified deadline The traditional opportunity for the public to present formal oral comments on a proposal; most effective if key points are presented succinctly, with supporting data; effectiveness depends on how well the statement is delivered as well as its content; registration for the public hearing is usually required Travel required to the location of the public hearing; advance notice may be relatively short; preparation required to ensure that the oral statement presented is effective; poor oral presentation or inadequate documentation may detract from the persuasiveness of the statement Opportunity to present views to the agency and other stakeholders in attendance; key points can be reinforced without getting lost in voluminous written comments submitted on a proposal; potential for interaction with other stakeholders to explore alternatives and develop consensus

(continued )

Poor written explanation or inadequate documentation may detract from the persuasiveness of the comments

Thoughtful consideration of the issues is possible out of the public eye; more issues can be addressed and more documentation provided compared to oral testimony; opportunity to place key information and documentation into the rulemaking record

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(Continued)

NDWAC meeting

FACA advisory committee

Stakeholder meeting participation

Event=Action

TABLE 11.2

Open public meeting held by the agency to brief and receive input on a regulation or regulatory issues; meeting typically facilitated by a neutral third party; stakeholders may provide oral comments, written comments, or both Formal advisory committee under FACA to address a regulatory issue or need; meetings are generally announced and open to the public; meetings generally include time for public comments during which stakeholders may present information and recommendations to the committee for consideration Formal NDWAC meetings and=or NDWAC work groups are held regularly; meetings are generally announced and open to the public; meetings generally include time for public

Characteristics

Issues will be considered by the advisory committee whose membership is balanced to represent all relevant interests; some opportunity for consensus between diverse stakeholders

Potential for dialog or consensus may be hindered by the presence of other stakeholders

Opportunity for clear presentation to USEPA regarding key issues; potential exists for dialog, exploration of alternatives and solutions, and development of consensus on possible approaches or solutions Issues will be considered by the advisory committee whose membership is balanced to represent all relevant interests; opportunity for consensus between diverse stakeholders

In general, the agency is not bound to accept the advisory committee’s recommendations

In general, the agency is not bound to accept the advisory committee’s recommendations

Limitations

Opportunities

257

Regulatory negotiation (reg-neg)

SAB Drinking Water Committee Meeting

comments during which stakeholders may present information and recommendations to the committee for consideration Formal SAB DWC meetings and SAB executive committee meetings are held regularly; meetings are generally announced and open to the public; meetings generally include time for public comments during which stakeholders may present information and recommendations to the committee for consideration Formal FACA advisory committee charged to negotiate the provisions of a proposed rule; meetings are generally announced and open to the public; meetings generally include time for public comments during which stakeholders may present information and recommendations to the committee for consideration In general, the agency is not bound to accept the SAB’s recommendations

Not all regulatory negotiations succeed, depending on the issues involved and the stakeholders involved

Issues will be considered by the SAB; some opportunity for consensus between diverse stakeholders

Issues will be considered by the reg-neg committee whose membership is balanced to represent all relevant interests, including USEPA; opportunity for consensus between diverse stakeholders

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11.4.1

PUBLIC INVOLVEMENT IN REGULATION DEVELOPMENT

Involvement Prior to Rule Proposal

Prior to issuance of a formal proposed rule, the agency has considerable flexibility in meeting with the public and discussing elements of an anticipated regulation. If time allows, USEPA may seek public comment prior to a formal proposal through one of several mechanisms. The agency could issue an Advance Notice of Proposed Rulemaking (ANPRM) in the Federal Register. The ANPRM provides an early warning that a regulation is being considered or will be developed. Public comments on particular aspects of the new rule are typically requested by the agency. Another mechanism used to solicit public input early in the rulemaking process is the issuance of draft discussion documents or a draft rule. These documents are usually not published in the Federal Register, although a notice of their existence is usually published on the USEPA OGWDW Website (www.epa.gov/safewater/ new.html). The draft may also include preliminary regulatory language and related issue papers that discuss various aspects of the draft rule. Stakeholder meetings, workshops, conferences, and public meetings sponsored by USEPA and others provide opportunities for the agency to discuss issues regarding new regulations with its publics. Stakeholder meetings facilitated by a neutral third party are frequently held on drinking water regulatory issues. Private informal meetings can also be held between USEPA and individuals or representatives from organizations to discuss technical data and regulatory options. USEPA may also issue status reports on a rule as a means to initiate public discussions. USEPA has total discretion as to whether to engage the public or any particular group in discussions prior to issuance of a proposed rule. Issuance of an ANPRM or a draft rule, meetings with specific groups, and participation in workshops and conferences are optional. The Agency has the freedom to not discuss the substance of a new rule with anyone and to develop a proposed rule totally on its own. The Agency could decide to meet with representatives of a specific organization but choose not to discuss any substantive issues regarding a specific future proposed rule. The Agency has discretion in determining the degree to which it will interact with stakeholders, and any specific organization, prior to rule proposal. No legal restrictions exist that prevent the Agency from meeting with specific organizations to discuss the elements of an anticipated rulemaking. However, certain perceptions will influence how the Agency interacts with interest groups and professional organizations. Not being perceived as showing favoritism to a particular stakeholder, for example, is considered particularly important when publics have irreconcilable differences on issues related to a rulemaking. The tendency in these cases, however, is for the Agency to become isolated, allowing it to be the final decisionmaker on issues of public dispute but at the same time hindering public involvement. This can foster an adversarial relationship between the Agency and various publics. The public can submit information, data, or ideas by writing to the Agency at any time. Consideration given to such letters depends mostly on the agency’s internal schedule. If time allows, information submitted to the agency, either from a meeting or by letter, is usually considered. If the agency has completed its internal delibera-

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259

tions on a proposal, referred to as ‘‘closure,’’ then the information may not be considered.

11.4.2

Involvement during Rule Proposal

The formal public comment period required by the APA is initiated by publication of the proposed rule in the Federal Register. The proposal will state the length of the public comment period, which ‘‘must be sufficient to fairly appraise interested parties of the issues involved, so that they may present responsive data or argument’’ (APA 1946). USEPA must inform the public of the data and assumptions on which the Agency’s proposal is based. Those interested must have an opportunity to ‘‘challenge the factual assumptions on which [the Agency] is proceeding and to show in what respect such assumptions are erroneous’’ (Congress 1974). In practice, the public will not have access to USEPA supporting documentation until the proposed rule is published in the Federal Register. Comments submitted by the public must be postmarked by the last day of the public comment period designated in the notice to be considered as part of the record for the rulemaking. The comment period is typically 30, 60, 90, or 120 days, depending on the complexity of the rulemaking. Comments received are placed in the drinking water docket, where they are available by appointment for public inspection and reproduction. Comments received after the close of the comment period are also placed in the docket and may be considered by the agency if time allows but are not considered as part of the rulemaking record that would be the subject of judicial review. Following the close of the comment period preceding promulgation of a new rule, the agency considers the comments received on the proposal and prepares a response. Technical support documents are updated and revised on the basis of comments received, and a final rule is prepared and issued.

11.4.3

Involvement after Rule Proposal

Open discussion with stakeholders is usually limited by USEPA after a proposed rule is signed by the administrator, at which time the agency is considered to have an official position. The primary concern regarding interaction with publics after administrator signature has to do with the possibility of the agency being influenced by ex parte communications. This refers to ‘‘off-the-record’’ communications between agency decisionmakers and other parties during informal rulemaking. Examples of ex parte communications might include special meetings of USEPA staff with an environmental group or water utility representatives, individual contacts, and even private telephone conversations. In the context of informal rulemaking, a communication is ex parte when it is an off-the-record, private discussion between agency decisionmakers and others concerning the substance of the agency’s proposed rule. As a result, public hearings held during proposed rule comment periods are typically very formal, with USEPA attorneys present, and a transcript is prepared for the rulemaking record.

260

11.4.4

PUBLIC INVOLVEMENT IN REGULATION DEVELOPMENT

Ex Parte Communications

The APA places no restrictions on ex parte communications made in informal rulemakings (ACUS 1991). In fact, the concept of ‘‘parties’’ and ‘‘off-the-record’’ contacts do not really apply in informal rulemaking under APA Section 553, because participation in informal rulemakings is not limited to named parties. Ex parte communications also are not restricted by the SDWA. Early court cases held that ex parte communications in informal rulemakings were improper (Home Box Office 1977). Later cases clarified the legality of ex parte communications in informal rulemakings (ACUS 1991, Hercules 1978, Sierra Club 1981). The importance to effective regulation of continuing contact with stakeholders cannot be underestimated. Informal contacts may enable the agency to win needed support for its program, reduce future enforcement requirements by helping those regulated to anticipate and shape their plans for the future, and spur the provision of information which the agency needs. Although court decisions allow ex parte communications in SDWA rulemaking, USEPA is very sensitive to unfavorable criticism that could occur if it were to base its decisions on private discussions with individuals outside the agency. Critics note that decisionmakers may be influenced by communications that may be made privately, which is counter to the need for accountable government. This is a particular concern when certain groups or individuals are allowed privileged access to upper-level management and decisionmakers at USEPA. Ex parte communications are feared to reduce the incentive to submit thoughtful comments or carefully prepared supporting data for people who believe that other interests have privileged access to decisionmakers. On the other hand, nonpublic candid contacts between the agency and interested parties can be useful in working out tentative and compromise solutions. Comments and supporting data must be presented to the agency at the time the rule is proposed in order to be considered as part of the rulemaking record. Comments and data submitted after the close of the comment period may be considered by the agency but will not necessarily be included as part of the rulemaking record that would be the subject of judicial review if the final rule were challenged in court. If a party was successful at persuading the agency to adopt a certain decision, the basis for the decision must be in the rulemaking record. Otherwise, the agency must open the record to make available for comment any new information on which its decision may be based. If the decision resulted in a final rule that differed substantially from the proposal, an additional notice and comment period would be needed under most circumstances (ACUS 1991). A USEPA administrator’s memorandum of May 31, 1985, instructs agency employees to ‘‘be certain (1) that all written comments received from persons outside the Agency (whether during or after the comment period) are entered in the public record for the rulemaking [and] (2) that a memorandum summarizing any significant new factual data or information likely to affect the final decisions received during a meeting or other conversations is placed in the public record’’ (ACUS 1991). This practice has been reaffirmed since that time and continues to be agency policy.

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261

In general, the OGWDW does not release information to one group outside the agency without making it available to other groups. Selected technical regulatory information might be released early at the appropriate time, such as technical information on cost, occurrence, and treatment technology. However, internal management recommendations and policy issues and options are generally not released until an agency management decision has been reached. A distinction is generally made between discussion of technical information and policy issues. The agency is generally willing to work with stakeholders to develop the best factual, technical information base for regulatory decisions but does not include the public in formulation of agency policy. When new information or arguments are received, issuance of a Notice of Data Availability (NODA) and reopening the comment period is the only mechanism available to ensure that everyone with the desire to has an opportunity to comment. If the agency is under a court-ordered deadline, flexibility may not exist to reconsider a proposal unless the new data or arguments presented are compelling enough for USEPA to convince the court to extend the schedule so that the record can be reopened.

11.5

FEDERAL AGENCY ADVISORY COMMITTEES

When formal public involvement is desired in the development of a particular regulation or guidance, USEPA may form an advisory committee. In general, an agency of the federal government is required to comply with the requirements of the Federal Advisory Committee Act (FACA) (FACA 1996) (see also Table 11.3) when it establishes or uses a group that includes nonfederal members as a source of advice. Under FACA, an advisory committee is established only after both consultation with the General Services Administration (GSA) and receipt of a charter from the agency forming the advisory committee. The primary function of an advisory committee is to assist elected or appointed officials by making recommendations to them on issues that the decisionmaking body considers relevant. These issues may include policy development, project alternatives, financial assistance applications, work plans, major contracts, interagency agreements, and budget submissions, among others. Advisory groups can provide a forum for addressing issues, promote constructive dialog among the various interests represented on the group, and enhance community understanding of the Agency’s action. When USEPA establishes an advisory committee, provisions of the FACA and GSA Regulations on Federal Advisory Committee Management must be followed. These requirements are:  The development of a charter that has been approved by the GSA and Office of Management and Budget (OMB). It must contain the committee’s objectives and the scope of its activities, the period of time necessary for the committee to carry out its objectives, the agency responsible for providing the necessary

262

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TABLE 11.3 Administrative Statutes and Executive Orders Affecting Public Participation in USEPA Rulemaking Federal Advisory Committee Act (FACA) Governs the establishment of and procedures for advisory committees that provide advice or recommendations to the federal government. Regulatory Flexibility Act (RFA), as amended by the Small Business Regulatory Enforcement Fairness Act (SBREFA) Generally requires agencies to assess the impacts on small entities, including small businesses, small governmental jurisdictions, and small organizations, of rules subject to notice and comment rulemaking requirements. For rules that may impose significant economic impacts on a substantial number of small entities (SISNOSE), agencies must prepare a regulatory flexibility analysis of the potential adverse economic impacts of small entities, participate in a Small Business Advocacy Review Panel (propose rule stage), and prepare a Small Entity Compliance Guide (final rule stage). For rules that impose a SISNOSE, public participation requirements include: opportunity for public comment on the agency’s initial regulatory flexibility analysis; opportunity for participation by small entities through the reasonable use of techniques including, among other things, open conferences, public hearings, and solicitation and receipt of comments over computer networks; and solicitation of advice and recommendations from small entity representatives identified by the agency after consultation with the Chief Counsel for Advocacy of the Small Business Administration. Unfunded Mandates Reform Act of 1995 (UMRA) Generally requires agencies to assess the effects on state, local, and tribal governments and the private sector of rules subject to notice and comment rulemaking requirements. Public participation requirements include: for rules containing significant federal intergovernmental mandates, agencies must develop an effective process to allow elected officials of state, local, and tribal governments (or their designated, authorized employees) to provide meaningful and timely input in the development of the regulatory proposal; and for rules that may significantly or uniquely affect small governments, agencies must develop a small government agency plan that provides for notifying potentially affected small governments, enabling officials of small governments to have meaningful and timely input in the development of regulatory proposals with significant federal intergovernmental mandates, and informing educating, and advising small governments on compliance with regulatory requirements. Executive Order 12898, ‘‘Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations’’ Generally requires each federal agency, to the greatest extent practicable and permitted by law, to make achieving environmental justice part of its mission by ensuring meaningful public participation of minority and low-income populations, including identifying potential effects and mitigation measures, and improving accessibility of public meetings, documents, and notices to affected communities. Executive Order 13175, ‘‘Consultation and Coordination with Indian Tribal Governments’’ Requires most federal agencies to develop and utilize an effective process that allows elected officials and other representatives of Indian tribal governments to provide meaningful and timely input on regulations, legislative comments, proposed legislation, and policies that have substantial direct effects on one or more Indian tribes, and to appoint a federal official to oversee the implementation of that process.

11.5 FEDERAL AGENCY ADVISORY COMMITTEES

TABLE 11.3

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(Continued)

Executive Order 12866, ‘‘Regulatory Planning and Review’’ Whenever feasible, agencies must seek views of appropriate state, local, and tribal officials before imposing regulatory requirements that might significantly or uniquely affect those governmental entities. Each agency must assess the effects of federal regulations on state, local, and tribal governments, including specifically the availability of resources to carry out those mandates, and seek to minimize those burdens that uniquely or significantly affect such governmental entities, consistent with achieving regulatory objectives. In addition, as appropriate, agencies must seek to harmonize federal regulatory actions with related state, local, and tribal regulatory and other governmental functions. Executive Order 13166, ‘‘Improving Access to Services for Persons with Limited English Proficiency’’ Requires each federal agency to examine the services it provides, and then identify, develop and implement a system by which limited-English-proficient persons can meaningfully access those services consistent with, and without unduly burdening, the fundamental mission of the agency. The order also requires that each federal agency draft guidance pursuant to Title VI of the Civil Rights Act of 1964, as amended, to ensure that recipients of federal financial assistance take reasonable steps to provide meaningful access to their programs and activities. Administrative Procedure Act (APA) Standardizes administrative procedures for all governmental agencies. For actions subjected to the APA’s formal rulemaking requirements (most USEPA rulemakings), the APA generally requires agencies to publish a general notice of proposed rulemaking in the federal register, and to give interested persons an opportunity to participate through submission of written data, views, or arguments. For actions subjected to the APA’s formal rulemaking or formal adjudication requirements, the APA prescribes additional procedures for agency hearings, which include, among other things, requirements for notice and an opportunity for interested parties to submit facts and arguments, proposed findings and conclusions, or exceptions to agency decisions. Negotiate Rulemaking Act of 1990 Authorizes federal agencies to use the formal regulatory-negotiation (reg-neg) process to formulate proposed rules. If consensus is reached, then the resulting rule is likely to be easier to implement and the likelihood of subsequent litigation is diminished. Even if consensus on a draft rule is not achieved, the process may be valuable as a means of better informing the regulatory agency of the issues and concerns of affected stakeholders. Although the agency is permitted to publish as its own the consensus proposal adopted by the negotiating committee, the agency is not required to publish either a proposed or final rule merely because a negotiating committee proposed it. Source: USEPA (2000a).

support for the committee, and a description of the duties for which the committee is responsible. The charter must be renewed every 2 years.  The Establishment Federal Register Notice. At least 15 days before the charter is filed for a new committee, USEPA is required to publish an establishment notice in the Federal Register. This notice describes the nature and purpose of

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the committee, the agency’s plan to attain fairly balanced membership, and a statement that the committee is necessary and in the public interest. Balanced membership. Advisory committees must be ‘‘fairly balanced’’ in points of view represented. The Meeting Federal Register Notice. Each advisory committee meeting must be noticed in the Federal Register at least 15 days prior to the meeting. To close a meeting to the public, approval must be obtained both from the USEPA Administrator and the USEPA General Counsel. Detailed minutes must be kept of all advisory committee meetings. Open meetings. Interested persons may file written statements with any advisory committee, attend any advisory committee meeting (unless properly closed), and appear before any advisory committee. DFO attendance. Each meeting must be attended by a Designated Federal Official (DFO), a full-time federal employee who is authorized to adjourn the meeting and approve the agenda. Documents available to the public. All advisory committee documents (including drafts) shall be available to the public on request.

An important characteristic of advisory committees formed under FACA is that membership on the committee is to be balanced so that all relevant stakeholder interests are represented. This does not mean that anyone with an interest in the issue may be a member of the advisory committee, but that committee members are specifically selected so that all necessary points of view are represented. When an advisory committee is formed under FACA to advise the agency on a regulatory issue, committee formation and all meetings are announced to the public by notice in the Federal Register. USEPA may provide advice and administrative support for FACA advisory committees, but in general, the committees function independently from the agency. A notable exception occurs when agency staff sit at the table and participate like any other committee member. In such cases, agency staff may steer the committee, either deliberately or unknowingly, toward the agency’s view or away from the view of other stakeholders. Two important permanent advisory committees formed under FACA used by USEPA for advice on drinking water regulations are the National Drinking Water Advisory Council (NDWAC) and the USEPA Science Advisory Board Drinking Water Committee (SAB DWC). In particular, since enactment of the 1996 SDWA amendments, USEPA has utilized the NDWAC and its working groups as a principal mechanism for obtaining public input and recommendations on a variety of regulatory issues.

11.5.1

National Drinking Water Advisory Council (NDWAC)

The NDWAC was established in the 1974 SDWA to ‘‘advise, consult with, and make recommendations to the administrator on matters relating to activities, functions, and

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policies’’ of USEPA under the SDWA. The 15 members of the NDWAC are appointed by the administrator. Five members each are appointed from the general public, appropriate state and local agencies, and representatives of private organizations or groups with an active interest in water hygiene and public water supply. Two members must represent small, rural public water systems. Nominations for appointment to the NDWAC are sought from the public each fall through a Federal Register notice. Members of the NDWAC receive compensation for the time they are engaged in the business of the council. The NDWAC usually meets several times each year. Meeting times and locations are announced in the Federal Register and usually include time for public statements. Meetings of the NDWAC can provide opportunity for public discussion of issues related to new regulations. Although USEPA’s OGWDW provides administrative support for the council, the council functions independently from USEPA. The agency is not obligated to seek the council’s advice on every matter, and it is not obligated to follow the council’s recommendations. 11.5.2

USEPA Science Advisory Board

The SDWA requires USEPA to request comments from the USEPA SAB before proposing any maximum contaminant level goal (MCLG) or National Primary Drinking Water Regulation. The SAB was first established administratively in 1973 as a part of USEPA’s Office of Research and Development. In 1976, the SAB was moved to the administrator’s office to provide it with more independence and to expand its scope. Congress provided statutory authorization for the SAB in 1978 under the Environmental Research, Demonstration, and Development Authorization Act (ERDA 1978a). One of the SAB’s statutory functions is to review and provide advice and comments on the scientific adequacy of ‘‘any proposed criteria document, standard, limitation, or regulation’’ issued by USEPA (ERDA 1978b). The importance of the SAB’s role was noted by Congress (1977a) in the legislative history of the SAB’s enabling legislation: In recognition that political and temporal pressures often weaken the credibility of scientific and technical data which support EPA’s regulatory program . . . [t]his legislation is intended to enhance the status, scope and responsibilities of the Board, leading to more vigorous and complete independent scientific review of data and analyses used for reaching decisions.

Congress (1977b) later commented [M]uch of the criticism of [EPA] might be avoided if the decisions of the Administrator were fully supported by technical information which had been reviewed by independent, competent scientific authorities.

The OGWDW typically initiates the SAB Drinking Water Committee (DWC) review process by submitting documents to the SAB for review or by requesting comment on specific issues. Documents released by USEPA to the SAB must also be made available to the public. The SAB DWC considers the issues and forwards its report to

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the SAB Executive Committee. Following SAB Executive Committee approval, the SAB DWC report is forwarded to the agency. The SAB can respond any time prior to promulgation of the regulation. USEPA does not have to postpone promulgation if no comments are received. Meetings of the SAB are announced in the Federal Register and usually include an opportunity for public statements. Agency representatives may or may not be present during public statements.

11.6

REGULATORY NEGOTIATION

The traditional APA rulemaking procedure can discourage affected stakeholders from communicating with one another. Stakeholders with different interests typically assume conflicting and antagonistic positions. The end result can be expensive and time-consuming litigation. Adversarial rulemaking deprives affected parties of the benefits of shared information, knowledge, expertise, and technical abilities. Cooperation in developing and reaching agreement on the provisions of a rule is also discouraged. The regulatory negotiation (reg-neg) process is conducted under the authority of the Negotiated Rulemaking Act of 1990 (NRA 1990). If used to develop a proposed rule, negotiations are held between members of a FACA advisory committee whose membership includes a representative of each affected interest. Meetings are facilitated by a neutral third party, are open to the public, and information is freely exchanged. New ideas and comments from the public can be offered to the advisory committee for consideration in its negotiations. A key feature of the reg-neg (regulatory negotiation) process is that a representative from USEPA functions as a member of the committee, negotiating with other committee members. The goal of committee deliberations is to reach consensus on the language or issues involved in the draft rule. Not all rulemakings, however, are appropriate for the reg-neg process. The process is instituted at the agency’s discretion, and not all reg-negs succeed. A successful reg-neg results in shared power and consensus building of regulatory solutions. If consensus is reached, then the resulting rule is likely to be easier to implement and the likelihood of subsequent litigation is diminished. Even if consensus on a draft rule is not achieved, the process may be valuable as a means of better informing the regulatory agency of the issues and concerns of affected stakeholders. Although the Agency (USEPA) is permitted to publish as its own the consensus proposal adopted by the negotiating committee, the Agency is not required to publish either a proposed or final rule merely because a negotiating committee proposed it. In the negotiative rulemaking process, a neutral, third-party facilitator is necessary to keep the process moving and provide mediation between negotiators. The facilitator becomes involved early in the process, even before a decision is made to use the negotiative process for rule development. The facilitator is critical to the success of each of the following phases involved in regulatory negotiation (Pritzker and Dalton 1990):  Evaluation Phase. In this first phase, the facilitator works with USEPA to identify the key stakeholders. The facilitator interviews each stakeholder and

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other knowledgeable sources to identify the critical issues, and provides a report to USEPA to assist the agency in deciding whether a negotiation is likely to succeed. Not all negotiations are successful. If stakeholders are too far apart in their issues and=or beliefs, or are unwilling to work toward solutions within a negotiative process with other stakeholders who may think differently than they do, then the agency may choose to use the traditional rulemaking approach, rather than risk expending resources on a negotiative process that is unlikely to succeed.  Convening Phase. Following the decision to use the negotiative process to develop a rule, the facilitator role changes to convener. The facilitator works with the stakeholders to set meeting dates and organizes and hosts the meetings. Ground rules are typically discussed and drafted at the first formal meeting, and ratified by the group at the beginning of the second meeting. Ground rules define the purpose of the discussions, participation, meetings, decisionmaking, agreement, schedule, and safeguards for the negotiators. Issues for future discussion are identified and a meeting schedule developed. Typically, several meetings may be needed to develop a baseline of shared knowledge, consisting of presentations of data by informed experts invited in advance by the negotiators. Consultants and researchers may be invited to present data or otherwise discuss issues and present opinions to the negotiators. All meetings are announced in advance and are open to the public.  Negotiation Phase. Once ground rules have been established, issues identified, and all relevant information presented and discussed, the facilitator guides the negotiators in identifying and evaluating regulatory options. As options are narrowed, the facilitator’s role is principally mediation.  Rulemaking Phase. If an agreement is reached, USEPA proceeds as agreed. A formal agreement is signed, whereby stakeholders agree to not contest or litigate issues for which agreement is reached. However, for issues where agreement was not reached, stakeholders reserve the right to comment and act, as they deem appropriate. Stakeholders reserve the right to comment and act, as they deem appropriate, on issues for which agreement was not reached. The agency develops a proposed rule based on the signed agreement in principle. Organizations are selected to participate as stakeholders during formal negotiations so that all identifiable interests or points of view are represented. Not every organization or individual that wants to participate will necessarily be represented at the negotiating table. For a negotiative regulatory process to succeed, there must be a limited number of identifiable stakeholders. On the other hand, representation at the negotiating table must be balanced in terms of points of view, and organizations must select representatives who can adequately represent the organization’s interests during negotiations. Organizations and negotiators involved must be willing to negotiate in good faith to reach ‘‘consensus.’’ There must be a reasonable likelihood ‘‘consensus’’ will be reached within the time limit that may be imposed by the SDWA and=or USEPA.

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The representatives at the negotiating table constitute the negotiating committee, or FACA committee, named after the federal law (FACA) under which the negotiations take place, discussed previously. Technical support is typically required during the negotiative rulemaking processes. All participants can provide their own technical support, or in some cases a separate technical working group is formed to provide analytical support and technical assistance to the entire negotiating committee. The primary purpose of the technical working group is to conduct scientific data analyses for the negotiating committee so that committee decisions can be based on the best available science. Needed analyses typically include the development of baseline estimates (treatment practices, risk estimates) and rigorous evaluation of regulatory options formulated by the negotiating committee (treatment impacts, risk reduction, benefits, and costs). The principal drawback to a regulatory negotiative process for rule development is that it typically requires significant resources and time. Deliberations can take many months or years, depending on the issues to be addressed. Regulatory deadlines may make stakeholder negotiations impractical. In some cases, only selected issues may be addressed to meet time constraints. To be successful, the creation of a negotiating committee to formulate a draft rule or principles of agreement involves elements of what might be termed ‘‘community.’’ Creation of a FACA committee necessarily involves the formation of an artificial community that includes the negotiators as well as their supporting organizations and other interested stakeholders. Individually, the negotiators and the organizations represented must have realistic expectations regarding what can be achieved working within this community of stakeholders. In some cases, certain organizations and=or individuals may have only fought with each other as enemies either politically or via the news media, never having entered into constructive dialog. The negotiative process provides an opportunity for such a dialog to occur, if the participants choose to work together toward common solutions, rather than simply fight. In other cases, organizations and=or individuals begin the process virtually unknown to each other, and a period of time is needed to develop rapport and effective working relationships. Stakeholders involved in negotiative deliberations reflect great diversity in their views and the expertise that they bring to the negotiating table. Individuals and=or organizations with fundamentally different worldviews regarding drinking water must learn to respect differences, and through the negotiative process shift from fighting each other to fighting the problem together. Although core values of individuals and=or organizations may differ, these differences help define boundaries, not necessarily barriers to productive discussions and formulation of solutions. An attitude of learning from others and seeking to build on common ground helps keep discussions moving in a positive direction.

11.7

JUDICIAL REVIEW

The final opportunity available to stakeholders to influence a USEPA rulemaking is judicial review of a newly promulgated rule. Rubin and Pontius (1993) have

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reviewed the basics of the judicial review process. Challenging a final agency rule in court can be costly and time-consuming. More importantly, litigation of a promulgated rule can impair or irrepairably damage informal working relationships between the agency and the petitioner. The risk involved must be evaluated carefully before a decision is made to legally challenge a final rule. Judicial review is discussed further in Chapter 9. 11.8

USEPA’S PUBLIC INVOLVEMENT POLICY

On Jan. 19, 1981, USEPA published its first agencywide Public Participation Policy (USEPA 1981): to ensure that managers plan in advance needed public involvement in their programs, that they consult with the public on issues where public comment can be truly helpful, that they use methods of consultation that will be effective both for program purposes and for the members of the public who take part, and finally that they are able to apply what they have learned from the public in their final program decisions.

The 1981 Policy complemented regulations on ‘‘Public Participation in Programs under the Resource Conservation and Recovery Act, the Safe Drinking Water Act, and the Clean Water Act,’’ 40 CFR Part 25, promulgated in 1979 (CFR 2002). Part 25 covers procedures that the Agency (or state, tribe, etc.) should or must follow. Like the 1981 Policy, these procedures address matters associated with information, notification, consultation responsibilities, public hearings, public meetings, advisory committees, responsiveness summaries, permit enforcement, rulemakings, and work elements in financial assistance agreements. Since issuance of the 1981 Policy, public involvement techniques have expanded. USEPA has also developed and extended its methods of ensuring compliance with environmental regulations through partnerships, technical assistance, information and data access, and public involvement under the laws it implements. In addition, public involvement has increasingly become an important part of agency decisionmaking at all levels, ranging from advisory committees for national rules to local involvement in permitting, cleanups, and other initiatives. Further, USEPA developed tools to assist in conducting public involvement and consultation. These include  RCRA Public Involvement Manual (EPA530-R–96–007, Sept. 1996)  Public Involvement in Environmental Permits: A Reference Guide (EPA599R00–007, Aug. 2000)  The Model Plan for Public Participation (EPA300-K–96–003, Nov. 1996)  Environmental Justice in the Permitting Process (EPA=300-R–00–004, Dec. 1999)  The Office of Pesticide Program’s How to Participate in EPA Decision-making (63 FR 58038, Oct. 1998).

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In July 1999, USEPA committed to evaluate and update USEPA’s public involvement requirements and assess how well its regulations and policies ensure public involvement in decision-making (USEPA 1999a). In November 1999, USEPA sought public comment opinion on whether the 1981 Policy needed to be revised and updated (USEPA 1999b). USEPA collected, analyzed, and posted public comments on the Internet at http://www.epa.gov/stakeholders. The formal review of USEPA’s public participation policy and regulations culminated in a December 2000 report (USEPA 2000a). USEPA concluded that the 1981 Policy was basically sound and workable, but required updating. On Dec. 28, 2000, (USEPA 2000b) the agency issued a Draft Public Involvement Policy (hereafter called the Draft Policy) updating and strengthening (but not fundamentally changing) the 1981 Policy. This Draft Policy applies to all USEPA programs conducted under the laws and Executive Orders that USEPA implements. The Draft Policy addresses public involvement in all of the USEPA decisionmaking, rulemaking, and program implementation activities. It states that The fundamental premise of this Draft Policy is that, in all its programs, USEPA should provide for meaningful public involvement. This requires that everyone at USEPA remain open to receive all points of view and extend every effort to solicit input from those who will be affected by decisions. This openness to the public furthers our mission to protect public health and safeguard the natural environment by increasing our credibility and improving our decision-making. Our willingness to remain open to new ideas from our constituents, and to incorporate them where appropriate, is absolutely essential to the execution of our mission. At the same time, we should not accord privileged status to any special interest, nor accept any recommendation or proposal without careful, critical examination.

The term the public is used in the Draft Policy in the broadest sense, meaning the general population of the United States. Many segments of ‘‘the public’’ may have a particular interest or may be affected by Agency programs and decisions. In addition to private individuals, ‘‘the public’’ includes, but is not limited to, representatives of consumer, environmental and other advocacy groups; environmental justice groups; indigenous people; minority and ethnic groups; business and industrial interests, including small businesses; elected and appointed public officials; the media; trade, industrial, agricultural, and labor organizations; public health, scientific, and professional representatives and societies; civic and community associations; faithbased organizations; research, university, education, and governmental organizations and associations; and governments and agencies at all levels. Public agencies that serve as coregulators may have a dual role; they can be beneficiaries of public involvement in their decisionmaking processes as well as stakeholders who provide input into USEPA’s decisions. The term public involvement is used in the draft policy to encompass the full range of actions and processes that USEPA uses to engage the public in the Agency’s work, and means that the Agency considers public concerns, values, and preferences when making decisions. Public involvement is intended to enable the public to work with the Agency and hold it accountable for its decisions.

Public involvement at USEPA relies heavily on discretion by Agency officials and a separate strategy for implementing the Draft Policy has been prepared (USEPA 2002). The Draft Policy states an intended bias in favor of public involvement. All reasonable efforts should be made to ensure that the public is informed and given appropriate opportunities for involvement. Those opportunities should not be judged solely by their quantity, but also by whether they are designed to improve the quality of USEPA’s decisions. Opportunity for public involvement in rulemaking that requires public notice and comment will always be provided, but not every document or decision requires public involvement. Every involvement opportunity does not call for the inclusion of all potentially interested persons; including representatives of various interests may be sufficient. Agency officials have the flexibility to determine appropriate public involvement, and recognize that agreement among all parties, while valuable, is not always needed. In addition, USEPA retains the discretion to make decisions or take actions to preserve and protect the environment and public health. The Draft Policy is not a rule, is not legally enforceable, and does not confer legal rights or impose legal obligations on any member of the public, USEPA, or any other agency. However, it is USEPA’s statement of a strong commitment to full and meaningful public involvement in Agency activities. As a policy, the Draft Policy is not binding on states, tribes, and local governments that implement federally delegated, authorized, or approved programs.

11.9

THE FUTURE OF PUBLIC PARTICIPATION

Public participation is an important aspect in the development of new regulations. The principal opportunity for public involvement in traditional rulemaking is the proposed rule comment period. Opportunities may exist prior to proposal of a rule for the public to discuss issues of concern with the agency and in public forums such as stakeholder meetings and through the NDWAC and SAB. Since enactment of the 1996 SDWA amendments, USEPA has increased the frequency of stakeholder meetings to provide opportunities to inform and engage stakeholders in meaningful discussions on a variety of anticipated rulemakings. USEPA has the discretion to discuss, share information, and work with the public, individuals, and specific organizations on issues related to a new rulemaking both before and after formal proposal. Stakeholders should take full advantage of opportunities to discuss with the agency the technical issues and facts bearing on a rulemaking prior to proposal. Stakeholder interaction is usually limited by the agency after proposal because of concerns regarding ex parte communications, perception of favoritism, or other reasons. Traditional rulemaking allows an opportunity for public input but rarely allows for meaningful interaction and consensus building. In contrast, stakeholder meetings and a formal FACA advisory committee or regulatory negotiation (reg-neg) process provide an alternative to the traditional rulemaking process, utilizing an open forum and consensus process to integrate various public concerns in the development of a proposed rule. An emerging chal271

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lenge will be to engage the public and stakeholders in regulatory discussions without releasing security-sensitive information or compromising the security of public water systems. Security concerns may limit the amount and=or type of data made available by USEPA for public review in the future.

REFERENCES APA. 1946. Legislative History of the Administrative Procedure Act. S. Document 248. 79th Congress, 2nd Session, 200. ACUS. 1991. A Guide to Federal Agency Rulemaking, 2nd ed. Washington, DC: Administrative Conference of the United States. CFR. 2002. Public Participation in Programs under the Resource Conservation and Recovery Act, the Safe Drinking Water Act, and the Clean Water Act. Code of Federal Regulations, Title 40, Part 25. Congress. 1974. House of Representatives Rept. 93-1606, 93rd Congress, 2nd Session, 33. Congress. 1977a. H.R. 95-157. House of Representatives Rept. 157, 95th Congress, 1st Session, 38. Congress. 1977b. H.R. 95-722. House of Representatives Rept. 722, 95th Congress, 1st Session, 16. ERDA. 1978a. Environmental Research, Demonstration, and Development Authorization Act. 42 USC Sec. 4365. ERDA. 1978b. Environmental Research, Demonstration, and Development Authorization Act. 42 USC Sec. 4365(e). FACA. 1996. Federal Advisory Committee Act. 5 USC App. 2, Secs. 1–15. Hercules. 1978. U.S. Court of Appeals 1978. Hercules Inc. v. EPA, 598 F.2d 91, D.C. Circuit. Home Box Office. 1977. U.S. Court of Appeals 1977. Home Box Office Inc. v. FCC, 567 F.2d 9 (D.C. Circuit), certification denied, 434 U.S. 829. NRA. 1990. Negotiated Rulemaking Act of 1990. P.L. (Public Law) 101-648. Pontius, F. W. 1993. Involving the public in developing regulations. J. Am. Water Works Assoc. 85:20. Pritzker, D. M. and D. S. Dalton. 1990. Negotiated Rulemaking Sourcebook. Washington, DC: Administrative Conference of the United States. Rubin, K.A. and F.W. Pontius. 1993. Influencing regulation through litigation. J. Am. Water Works Assoc. 85:19. SAB 2001. Improved Science-Based Environmental Stakeholder Processes. EPA-SAB-ECCOM-01-006. Washington, DC: USEPA Science Advisory Board. Sierra Club. 1981. U.S. Court of Appeals 1981. Sierra Club v. Costle, 657 F.2d 298, D.C. Circuit. USEPA. 1981. EPA Policy on Public Participation. Fed. Reg. 46:5736. USEPA. 1999a. Aiming for Excellence: Actions to Encourage Stewardship and Accelerate Environmental Progress. EPA 100-R-99-006. Washington, DC: USEPA. USEPA. 1999b. Review of Environmental Protection Agency Public Participation Policies. Fed. Reg. 64:66906–66913.

REFERENCES

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USEPA. 2000a. Engaging the American People: A Review of EPA’s Public Participation Policy and Regulations with Recommendations for Action. EPA 240-R00-005. Washington, DC: Office of Policy, Economics and Innovation. USEPA. 2000b. Draft Public Involvement Policy; Proposed Policy. Fed. Reg. 65:82335–82345. USEPA. 2002. Draft Recommendations for Implementing EPA’s Public Involvement Policy. January 10. Washington, DC: Office of Policy, Economics and Innovation.

PART III CONTAMINANT REGULATION AND TREATMENT

Drinking Water Regulation and Health, Edited by Frederick W. Pontius. ISBN 0-471-41554-5 # 2003 John Wiley & Sons, Inc.

12 CONTROL OF DRINKING WATER PATHOGENS AND DISINFECTION BYPRODUCTS STIG E. REGLI Environmental Engineer, Office of Ground Water and Drinking Water, U.S. Environmental Protection Agency, Washington, DC

PAUL S. BERGER, Ph.D. Microbiologist, Office of Ground Water and Drinking Water, U.S. Environmental Protection Agency, Washington, DC

THOMAS R. GRUBBS, P.E. Environmental Engineer, Office of Ground Water and Drinking Water, U.S. Environmental Protection Agency, Washington, DC

12.1

INTRODUCTION

The purpose of this chapter is to review how the U.S. Environmental Protection Agency (USEPA) has developed federal drinking water regulations that control for pathogens and disinfection byproducts (DBPs). Pathogens and DBPs are considered together because control for either one of these groups of contaminants has a direct influence on the other. This chapter is organized chronologically to inform how perception of public health concern from pathogens and DBPs has changed, how this has influenced changes in the Safe Drinking Water Act (SDWA), and how the SDWA has influenced regulation development by USEPA. 12.2

CONTROL OF WATERBORNE PATHOGENS BEFORE THE 1970s

Early development of U.S. drinking water standards is discussed in Chapter 1, but is reviewed briefly here as related to waterborne pathogens. Federal legislation to Disclaimer: The views expressed in this chapter are those of the authors and do not necessarily reflect the views or policies of the USEPA. Drinking Water Regulation and Health, Edited by Frederick W. Pontius. ISBN 0-471-41554-5 # 2003 John Wiley & Sons, Inc.

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control infectious disease in the United States began with the National Quarantine Act of 1878. This law was designed to prevent the introduction of infectious diseases into the United States. The Act was modified in 1890 and 1893, giving the Treasury Department authority to prevent the introduction of contagious diseases across state lines. In 1912, as a result of severe outbreaks of intestinal disease among steamship passengers on the Great Lakes, the Treasury Department issued the first waterrelated regulation, which prohibited the use of a common drinking water cup aboard interstate carriers such as ships and trains (McDermott 1973). The 1912 regulations led to the 1914 Treasury Department standards, which prescribed mandatory limits for bacteria in interstate carrier supplies. Under these standards, the level of Bacteria coli (i.e., coliform bacteria) were limited to less than 2.2 coliforms per 100 mL, and the total bacterial count was not to exceed 100 mL. Later revisions of the drinking water standards by the U.S. Public Health Service (USPHS) in 1925, 1942, 1946, and 1962 modified the coliform standard and added standards for several inorganic chemicals. In 1925, the total bacterial count requirement was dropped when a standard was established for turbidity, which is a rough measure of the cloudiness of the water (created by light scatter due to particulate matter). The recommended monitoring frequency was based on expert judgment (NRC 1977). Table 12.1 provides a history of the early coliform standards from 1914 through 1962. Thus, up through the early 1970s, the only federal mandate, the U.S. Public Health Service Act, covered interstate carrier supplies (train stations, ship terminals, etc.), but not other drinking water supplies. The nation’s drinking water supplies were primarily protected by state and community standards, although many states lacked legal authority to require water systems to comply with existing standards (Congress 1976). Why were coliform bacteria used during this period as an index of water pollution? The reason is that these microbes were common in the gut of warm-blooded animals and could be measured easily. Coliforms are a group of closely related bacteria (family Enterobacteriaceae) that are nonsporeforming, facultatively anaerobic, Gram-negative staining rods that ferment the sugar lactose, producing acid and=or gas. Few other bacteria ferment lactose. Thus, by using culture media that contained lactose as the only carbohydrate, and a means for detecting acid or gas production, coliforms could be differentiated from other bacteria without difficulty. Any bacterium that grew in the culture, producing acid and=or gas, was identified as a coliform, regardless of its genus or species; thus coliforms were identified operationally rather than taxonomically. In practice, most coliforms are Escherichia coli or species of Klebsiella, Enterobacter, and Citrobacter. Of the many coliform strains, only a tiny minority are pathogenic. The use of the coliform group as a fecal indicator was controversial from the beginning. The difficulty is that most coliforms are also widespread in natural water and soil. Thus a coliform-positive sample does not necessarily indicate fecal contamination. One coliform, Escherichia coli, seldom survives outside the gut for long and thus was considered a satisfactory fecal indicator, but the absence at that time of a suitable culture medium that could distinguish E. coli in a mixture of many other

12.2 CONTROL OF WATERBORNE PATHOGENS BEFORE THE 1970

TABLE 12.1

Federal Microbial Drinking Water Standards for Interstate Carriers

Standard 1914 (Treasury)

1925 (USPHS)

1942 (USPHS)

1946 (USPHS) 1962 (USPHS)

279

Requirements=Limits Total number of bacteria on standard agar plate (24 h, 37
C) 100=mL Bacterium coli present in no more than one of five tubes, each with 10-mL lactose-containing broth (B. coli same as coliform group) B. coli present in 3 of 5 tubes, each with 10-mL lactosecontaining broth, in more than 5% of samples when 20 samples=month One sample when <20 samples=month B. coli present in 10% of the tubes If 5 tubes, each with 10-mL lactose-containing broth, are used, then limits are same as the 1925 limits (except that term ‘‘coliform group’’ is used instead of B. coli) If 5 containers, each with 100-mL lactose-containing broth, are used, then coliform group cannot be present in all 5 containers in more than 20% of the tubes when 5 samples=month One sample when <5 samples=month If 5 containers, each with 100-mL lactose-containing broth, are used, then coliform group cannot be present in 60% of the containers=month Check samples—if coliforms present in 3 tubes (10-mL portions) or all 5 containers (100-mL portions), then daily check samples taken until results satisfactory Turbidity: 10 ppm (silica scale) Same as 1942 standards, except use of check samples clarified Either lactose-containing broth (now called fermentation tube method ) or membrane filter technique may be used If lactose-containing broth is used, limits are same as 1942 standard If membrane filter is used, coliform colonies shall not exceed 3=50 mL, 4=100 mL, 7=200 mL, or 13=500 mL in 2 consecutive samples: >1 sample when <20 samples=month >5% of samples when 20 samples=month If membrane filter is used, the arithmetic mean coliform density of all samples collected per month shall not exceed 1 colony=100 mL Monitoring frequency based on population served, ranging from 2 to 500 per month, as agreed to by the state and USPHS Turbidity: 5 units

waterborne bacteria precluded its use. Other organisms were proposed as fecal indicators during this period, but only the enterococci and fecal coliforms were given serious consideration (Geldreich 1966, Kabler and Clark 1960, Committee on Public Health Activities 1961). Fecal coliforms are a subgroup of coliform

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bacteria that are distinguished by their ability to grow at elevated temperatures (now defined as 44.5
C) and primarily consist of E. coli. To clarify terminology, the terms ‘‘coliforms,’’ ‘‘coliform group,’’ ‘‘coliform bacteria,’’ and ‘‘total coliforms’’ are interchangeable. Although coliform standards changed over the years, they were all based on the density of coliform bacteria in water. The technical basis for the various coliform density standards during the early years is not obvious, but apparently was the result of expert judgment based on experience. The minimum required monitoring frequency was not based on any statistical review, but rather on what was considered attainable for systems that were under careful control (Woodward 1959). Even before the 1962 standards were published, the public health community was finding increasing reason to question the effectiveness of total coliforms as an index of safety in drinking waters containing the hepatitis A virus and the protozoan pathogen, Entamoeba histolytica (Committee on Public Health Activities 1961).

12.3 CONTROL OF WATERBORNE PATHOGENS AND DBPs IN THE 1970s During the early 1970s, the 1962 USPHS drinking water standards were in effect, at least for interstate carriers. However, the results of several investigations were published in the early 1970s that further challenged the effectiveness of the USPHS standards. For example, in 1969=70, the USPHS conducted a national survey of 969 public water supplies to determine whether they were meeting the current standards. Of the 969 supplies, including those of 22 cities, only 59% met the USPHS coliform limits, and only 10% met both the coliform limits and the monitoring frequency recommended by the USPHS standards (McCabe et al. 1970). In addition, as part of another study, 36 synthetic organic chemicals were found in the drinking water of the system serving New Orleans. The USPHS standards did not address organic contaminants. These national survey findings were among the most important in prompting Congress, in 1974, to pass the SDWA. This legislation broadened coverage to all water systems that regularly provided drinking water to at least 25 people or had at least 15 service connections (SDWA 1974). This legislation (and subsequent amendments) provides the legal basis for all USEPA drinking water regulations. The 1974 SDWA required USEPA to publish (the legal term is ‘‘promulgate’’) regulations using a phased approach. First, USEPA was directed to publish National Interim Primary Drinking Water Regulations (NIPDWRs), based on the 1962 USPHS standards. Then the Agency was directed to contract with the National Academy of Sciences (NAS) for a 2-year study to identify and describe all potentially harmful contaminants in drinking water, both biological and chemical. Finally, USEPA was required to publish more comprehensive drinking water standards, based on the NAS study and other data found in the literature or the results of ongoing research. The SDWA also provided USEPA with direction on developing drinking water regulations. USEPA was to publish regulations for any contaminant that might pose a

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health risk. Setting regulations was to be a two-step process. First, USEPA was to publish a recommended maximum contaminant level [RMCL; later known as a maximum contaminant level goal (MCLG)] for each contaminant to be regulated. The RMCL=MCLG, which was a federally nonenforceable health goal, was to be set at a level such that no adverse health effect would occur, with an adequate margin of safety. The sole reason for publishing the RMCL=MCLG was to inform the public what the Agency considered a safe concentration. Second, USEPA was to set the maximum contaminant level (MCL), which was federally enforceable, as close to the RMCL=MCLG as feasible, taking state and utility implementation costs into account. The SDWA allowed USEPA to set a treatment technique requirement for a contaminant, in lieu of an MCL, if it could not be measured accurately at the level of health concern (because the analytical method was not sufficiently sensitive or was too costly). 12.3.1

Total Coliform Rule (TCR)

Prompted by the SDWA requirements, USEPA published the NIPDWRs in 1975, extending the 1962 USPHS standards, coliforms included, to all public water systems. The TCR consisted of two types of maximum contaminant levels (MCLs): the single-sample MCL and the monthly average. Both MCLs were based on the density of total coliforms and were complicated. They varied with the analytical method, the sample volume, and the number of samples collected per month. For example, if a system collected fewer than 20 samples per month and used the membrane filter technique to test for total coliforms, the single-sample MCL was no more than 4 coliforms=100 mL in more than one sample per month. Under the TCR, systems were required to monitor for total coliforms in the distribution system at a frequency based on the number of people a system served. The required minimum monitoring frequency ranged from 1 sample per month for systems serving 1000 or fewer people to 500 samples per month for systems serving more than 4,690,000 people. States were allowed to reduce monitoring for small community water systems (CWSs) that used protected ground waters and for noncommunity water systems (NCWSs). (CWSs are public water systems that regularly serve at least 25 year-round residents, while NCWSs are public water systems that regularly serve an average of at least 25 individuals daily at least 60 days out of the year, but not 25 residents year-round.) If the coliform density in a single sample exceeded a particular value (depending on the method and sample volume), the system was required to collect daily check samples from the same site until two consecutive samples were coliform-negative. With approval from the state, a system could substitute chlorine residual monitoring for up to 75% of the required number of coliform samples, if that system maintained at least 0.2 mg=L of free chlorine throughout the distribution system and met other chlorine monitoring requirements. Provisions of the 1975 TCR are summarized in Table 12.2. One SDWA provision is the public notification requirement. Unlike the USPHS standards, if any MCL is exceeded, including those for total coliforms, the system is required to notify the public within a specified time and manner. Other than public

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TABLE 12.2

USEPA’s 1975 Total Coliform Rule

Rule Component Limits

Monitoring location Monitoring frequency Action after positive sample Analytical methods Other requirements

Requirements=Limits ‘‘Single’’ sample limit—based on coliform density and varied with the analytical method used (fermentation tube technique vs. membrane filter), sampling frequency per month (<20 vs. 20þ), and sample volume Monthly average limit—based on coliform density and varied with the analytical method used and sample volume Representative points within distribution system Based on population served, ranging from quarterly to 500 per month Check samples daily, until 2 consecutive samples satisfactory Fermentation tube technique and membrane filter technique Use best source water available Systems allowed to monitor chlorine residual as substitute for up to 75% of required coliform samples, at rate of 4 chlorine samples for each required coliform sample. Required chlorine residual  0:2 mg=L under this provision

notice and check samples, the 1975 TCR did not require remedial action after either type of MCL violation (although a state, at its discretion, could set more stringent requirements). The rationale for using total coliforms continued to evolve from being a conservative indicator of fecal contamination to a convenient indicator of treatment efficiency and distribution system integrity. The premise was that treatment that controlled coliforms would also minimize the likelihood of pathogen occurrence. Thus, total coliforms began to be used to assess the vulnerability of a system to fecal contamination, not whether the system was fecally contaminated. 12.3.2

Turbidity and Heterotrophic Bacteria

Among the other USEPA standards set in 1975 was one for turbidity. The USEPA regulation set a MCL for turbidity of 5 nephelometric turbidity units (NTUs) for systems using surface waters, and required such systems to monitor turbidity levels daily. The Agency’s primary reason in 1975 for regulating turbidity was to minimize its interference with chlorine disinfection. The Agency also recommended (but did not require) that systems monitor bacterial plate counts [also called standard plate count, heterotrophic plate count (HPC), total bacterial counts, etc.]. The bacterial plate count is the total number of bacterial colonies per sample volume growing on a

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specified culture medium under defined incubation conditions; it is used as a rough index of drinking water quality. The premise is that a high HPC, or a sudden increase in HPC, reflects inadequate water treatment. In 1977, the use of a coliform standard and HPC was supported by the National Research Council (NRC 1977). 12.3.3

Trihalomethanes (THMs)

In the early 1970s, researchers in the Netherlands and the United States demonstrated that THMs are formed as a result of drinking water chlorination (Rook 1974, Bellar et al. 1974). This class of disinfection byproducts (DBPs) is generated when the disinfectant chlorine reacts with naturally occurring material (called precursors) in the water. USEPA subsequently conducted the National Organics Reconnaissance Survey (NORS) of halogenated organics (Symons et al. 1975) to measure the concentrations of four THMs (chloroform, bromodichloromethane, dibromochloromethane, and bromoform) in the raw water and treated water of 80 communities nationwide and to determine what effect the raw water source and water treatment practices had on the formation of these compounds. NORS indicated that chloroform occurred invariably in water that had been chlorinated, while it was absent or at much lower concentrations in raw water. Of the four THMs [collectively known as total THMs or (TTHMs)], chloroform represented about 75% of the total concentration. Among the 80 communities surveyed, chloroform concentrations were found to be as high as 0.311 mg=L and concentrations for TTHMs were as high as 0.482 mg=L, with a mean TTHM concentration of 0.067 mg=L. A subsequent USEPA study, the National Organics Monitoring Survey (NOMS) (USEPA 1978), found results similar to those of the NORS. The data collected under NORS and NOMS, as well as other research, indicated that TTHM levels in drinking water vary depending on the season, chlorine contact time, water temperature, water pH, type of water (i.e., groundwater vs. surface water), chemical composition of the raw water (especially bromide concentration), and treatment methodology. During this time, toxicologic studies conducted on rats and mice indicated that chloroform was carcinogenic (NRC 1977). While cancer bioassay studies were only available for chloroform, USEPA was concerned that other THMs, as well as other DBPs, that could not be measured, might pose health risks. In 1979, to address the above-mentioned concerns, USEPA published a regulation that set an MCL of 0.10 mg=L for TTHMs. This value was based on the feasibility of measuring and controlling for TTHMs, and the need to balance the requirement for continued disinfection to control pathogens while simultaneously lowering exposure to TTHMs (USEPA 1979). Systems serving 10,000 people or more were required to collect four distribution system samples per quarter for each water treatment plant, and determine MCL compliance based on a running annual average (i.e., an average of all samples collected during the most recent four quarters). The standard also allowed a state to reduce the monitoring frequency for systems that could demonstrate that TTHM levels were consistently below the MCL. USEPA limited the TTHM standard to larger systems because the majority of small systems use

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groundwaters that are low in THM precursor content and because of concern that smaller systems might lack the technical expertise needed to control TTHMs properly without undermining pathogen control.

12.4 CONTROL OF WATERBORNE PATHOGENS AND DBPs IN THE 1980s During the early 1980s, USEPA’s major focus in drinking water was on toxic and carcinogenic chemicals. One reason for this focus was the conventional wisdom among many that waterborne pathogen control was a mature field, and that the technology for controlling pathogens was well understood. Thus additional regulatory effort in this area was of subordinate interest. Subsequent findings and events slowly shifted USEPA’s direction on this point. The periodic surveillance reports of waterborne disease outbreaks published by the Centers for Disease Control and Prevention (CDC) suggested that incidence rates were still high, especially given the premise that few outbreaks are recognized and reported. One USEPA-funded study in Colorado, for example, found that only about one-quarter of these outbreaks were being recognized and reported (Harter et al. 1985), and other studies suggested a higher rate of unreported waterborne disease (Bennett et al. 1987). Moreover, newly recognized waterborne pathogens were being identified, including the protozoa Giardia and Cryptosporidium, the bacterium Legionella, and the caliciviruses (including the Norwalk agent). Some of these pathogens were found to be more resistant to disinfection than the total coliforms, undermining the belief that pathogen control was mature. In addition, traditional assumptions on filtration and disinfection efficacy began to be questioned. In one study, enteroviruses were found in the filtered water of a large water system that employed full treatment (Payment 1981). One epidemiology study indicated that drinking water was linked to nosocomial (i.e., hospital-acquired) infections caused by the opportunistic bacterial pathogen group, Mycobacterium avium complex (Du Moulin and Stottmeier 1986). These concerns led USEPA to evaluate the need for regulatory activity to control these newly recognized pathogens and reduce outbreaks (USEPA 1983, 1985). This activity was strongly bolstered by the 1986 SDWA reauthorization. In this reauthorization, Congress, frustrated by USEPA’s slow progress in publishing regulations (Pontius and Clark 1999), required USEPA to regulate 83 specified contaminants by 1989, including total coliforms, turbidity, viruses, Giardia lamblia, Legionella, and heterotrophic plate count (HPC). Congress also directed USEPA to publish regulations requiring all water systems to disinfect, with appropriate criteria for waivers (called variances). In addition, the reauthorization also required USEPA to establish criteria under which filtration would be required by systems using surface water sources. These Congressional mandates affirmed the direction that USEPA was already proceeding in controlling pathogens. In contrast to USEPA’s strategy for controlling harmful chemicals in drinking water by establishing an MCL for each chemical, the

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Agency approach for controlling pathogens was to set a treatment technique requirement instead. More specifically, USEPA’s approach was to (1) assess, by use of water type (i.e., groundwater vs. surface water) and water quality indicators, the extent to which treatment might be needed; (2) set treatment requirements based on a specified pathogen removal=inactivation level; and (3) use water quality and engineering design and operating indicators to ensure that any required treatment was sufficient and reliable. This approach assumed that routine pathogen monitoring was not economically or technologically feasible, and thus setting MCLs were inappropriate. In response to Congressional direction, in 1989 USEPA published a revised TCR (USEPA 1989b) and the Surface Water Treatment Rule (SWTR) (USEPA 1989a). These rules were meant to complement each other and are described below. 12.4.1

Revised Total Coliform Rule

USEPA embarked upon a revision of the 1975 TCR to address perceived shortcomings of the rule. Among the shortcomings were (1) an inadequately documented technical basis for the MCLs, (2) complexity of the MCLs, (3) concern that the monitoring frequency for small systems was not sufficient to determine water quality, (4) concern that coliform-positive samples were being invalidated or disregarded too readily as merely being a local plumbing system problem or improper sample collection and handling, (5) concern that systems were not required to determine whether a total coliform-positive sample was the result of fecal contamination (i.e., contained E. coli) that would have necessitated an urgent response, and (6) concern that some major parts of the distribution system were not being monitored. One shortcoming of the TCR, the previously mentioned deficiency of total coliforms as an indicator of Giardia and Cryptosporidium, was to be addressed by the SWTR and by upcoming rules pertaining to groundwater disinfection. The revised TCR, published in 1989, based the MCL on the presence or absence of total coliforms in a 100-mL sample, rather than on coliform density, as before. This was done for several reasons: (1) data in the literature do not demonstrate a quantitative relationship between coliform densities and either pathogen density or the potential for a waterborne disease outbreak, (2) the revised MCL is easier to understand, (3) it is simple to determine the presence or absence of coliforms and not have to consider the uncertainties associated with estimates of coliform density, and (4) there is less concern about coliform die-off during the time between sample collection and analysis because any decrease in coliform density will seldom result in a complete die-off of all coliforms in that sample. The technical basis of the MCL was based on a study of small systems that found that coliforms are distributed very unevenly in the distribution system; the pattern follows a lognormal distribution, and the variance is large (Pipes and Christian 1982, Christian and Pipes 1983). According to the study, if 60 or more samples are collected, and no more than 5% are coliform-positive, then a 95% confidence exists that the fraction of water with coliforms present is less than 10%. USEPA defined a reasonably safe drinking water as one that contained coliforms in no more than 10% of its volume. This led USEPA to set a MCL of 5.0%; thus, no more than

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5.0% of the total coliform samples collected during a month could be positive. The revised TCR, however, allows small systems to have one coliform-positive sample per month without being in violation of the MCL, because an infrequent coliformpositive sample probably is not a health risk. The nonuniform coliform distribution also is problematic with regard to the required monitoring frequency. On the basis of study data, even when the arithmetic mean coliform density in distribution system water was greater than 1=100 mL, the probability that a 100-mL sample would not contain even a single coliform cell was high. Consequently, a few samples per month would not adequately represent water quality. Thus, USEPA proposed to increase the monitoring frequency for small systems, compared to the 1975 rule. Heavy and passionate opposition from states and small systems concerned about implementation costs led USEPA to conclude that the proposed approach was not feasible. The revised TCR, as finally published, represented a compromise. Under the revised TCR, the monitoring frequency for a small system was similar to the previous rule; however, a system collecting fewer than 5 samples per month (generally systems serving 4100 people or fewer) must have an on-site sanitary survey (i.e., inspection) every 5 years, with some exceptions. The combination of sampling and a periodic sanitary survey allows a small system to have an adequate grasp of its drinking water quality. The term ‘‘sanitary survey’’ was defined as an on-site review of the water source, facilities, equipment, operation, and maintenance of a system to determine whether it could deliver safe water. Conceptually, the revised TCR assumes that small systems are providing the public with safe water. However, a total coliform-positive sample brings this assumption into question. Given the uneven coliform distribution, two coliformfree ‘‘check’’ samples after a total coliform-positive sample cannot be used to invalidate the positive sample. The TCR assumes that all coliform-positive samples are valid; although it allows a state to invalidate a total coliform-positive sample under certain situations, the criteria for invalidation are narrow and the procedures precisely defined. Under the revised TCR, after a total coliform-positive sample, the system must collect a set of repeat samples (3 or 4) within 24 hours and then at least 5 routine samples during the next month of operation. If all repeat samples and remaining routine samples the same month and all routine samples the next month are coliform-negative, then some assurance is provided that the contamination is not extensive or has been eliminated. Also every total coliform-positive sample must be tested for the presence of either fecal coliforms or E. coli. If either is present, the drinking water is fecally contaminated, an acute health risk may exist, and the state must be alerted quickly. The revised TCR eliminated the chlorine substitution policy of the 1975 TCR because no utility was using this provision. The more important provisions of the revised TCR are summarized in Table 12.3. 12.4.2

Surface Water Treatment Rule (SWTR)

To respond to the SDWA mandate to control the pathogens mentioned in the previous section (Giardia, viruses, and Legionella) in surface water and to meet

12.4 CONTROL OF WATERBORNE PATHOGENS AND DBPs IN THE 1980s

TABLE 12.3

287

Revised Total Coliform Rule

Rule Component MCL

Monitoring location

Monitoring frequency

Action after positive sample

Analytical methods Sanitary surveys Sample invalidation

Requirements=Limits If system collects 40þ samples per month, no more than 5.0% of the monthly samples (routine þ repeat) can be total coliform-positive If system collects < 40 samples per month, no more than one sample per month can be total coliform-positive If a routine and repeat sample from a site are total coliform-positive, and one is also E. coli- or fecal coliform-positive (acute MCL violation) Samples collected throughout distribution system according to a sample siting plan subject to state approval CWS: 1–480 samples=month, based on population served CWS: 1 sample=quarter if system serves 25–1000 people, uses a protected groundwater, and passes a sanitary survey NCWS: If system uses surface water or groundwater under the direct influence of surface water, or if it serves >1000 people, it must monitor at same rate as CWS of comparable size Other NCWSs: quarterly (less in some circumstances) Test total coliform-positive culture for presence of either fecal coliforms or E. coli Collect a set of repeat samples (3 or 4) within 24 h; one must be at the same site as the original positive, the others must be upstream and downstream within 5 service connections of the positive Collect at least 5 routine samples the next month of operation (some exceptions) Both routine and repeat sample results count toward MCL determination If MCL violation, notify state and public Only EPA-approved methods used for compliance samples If system collects <5 samples=month, it must have on-site sanitary survey every 5 years (some exceptions) State may invalidate positive sample if (1) laboratory admits analysis error, (2) repeat sample is positive at original positive site and negative at other sites within 5 service connections (i.e., plumbing system problem), (3) substantial grounds exist that positive result does not reflect water quality and state documents rationale in writing State must invalidate negative sample if coliform test indicates that high levels of heterotrophic bacteria may have interfered with coliform analysis System must resample within 24 h

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the 1986 SDWA mandate regarding the filtration of systems using surface water sources, USEPA published the SWTR in 1989. The SWTR also met the SDWA mandates to control HPC and turbidity and, at least for systems using surface water, to require these systems to disinfect. The SWTR set MCLGs of zero for Giardia, viruses, and Legionella, because USEPA was not aware of any pathogen concentration other than zero at which it was safe to drink the water. The Agency set a treatment technique requirement rather than MCLs for these pathogens because pathogen monitoring was not considered economically or technologically feasible. The SWTR applies to all systems using surface water or groundwater under the direct influence of surface water (such as springs and shallow wells). Such groundwaters have been associated with waterborne giardiasis. The SWTR was structured to require adequate treatment effectiveness, ample treatment reliability, and protection from pathogen intrusion into the distribution systems. Each of these elements had been implicated as causing a growing number of waterborne disease outbreaks during the 1970s and 1980s (Craun 1988). Of special concern were unfiltered surface water systems, which had been associated with a waterborne disease outbreak rate that was 8 times that of filtered systems (USEPA 1989a). A central issue in developing the SWTR was what minimum level of treatment should be set. Two perspectives were considered in addressing this issue. One perspective was to define the level of treatment that could be attained by a welloperated system using conventional treatment (coagulation, flocculation, sedimentation, rapid granular filtration, chlorine disinfection). Such systems rarely had been implicated in a waterborne disease outbreak. Research on filtration and disinfection indicated that such systems could achieve at least a 3log (99.9%) and 4log (99.99%) reduction through the removal and=or inactivation of Giardia and viruses, respectively. The second perspective was to establish an acceptable health risk value for Giardia and determine the level of treatment needed to achieve this value. Giardia was used as the target organism to evaluate risk because this organism is substantially more resistant than viruses to disinfection, and USEPA assumed that if Giardia were treated to acceptable levels, viruses would also likely be treated to acceptable levels. In addition, more source water occurrence data were available for evaluating risk from Giardia than for viruses. On the basis of these data, USEPA estimated that a 3log removal=inactivation level for Giardia would provide, for most systems, an annual risk of infection rate of less than one in 10,000 (104). This risk level was considered comparable to other risk guidelines (Regli et al. 1988, Macler and Regli 1993). USEPA recognized that systems with poor source water quality might have a higher risk, even after a 3log treatment, but decided not to base the treatment level on the density of Giardia in the source water, given the absence of an adequate analytical method to recover and enumerate this pathogen in a system’s source water. However, USEPA did recommend that systems with poor-quality source water consider additional treatment.

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Both perspectives supported the treatment criterion that provide the central requirement of the SWTR; specifically, all systems are required to use a level of treatment sufficient to achieve a 3log removal=inactivation of Giardia and a 4log removal=inactivation of viruses. Systems practicing filtration could meet these criteria by using standard design and operating conditions. To ensure that systems were meeting the specified removal=inactivation criteria, the SWTR requires filtered systems to measure finished water turbidity (i.e., the turbidity level of the filtered water before the water enters the distribution system) and the disinfection residual both entering and within the distribution system. The SWTR turbidity limits and monitoring requirements, which depend on the type of filtration process used and the number of people the system serves, and the disinfection criteria are provided in Table 12.4. To ensure public health, an unfiltered system has to meet stringent source water quality criteria, maintain an effective watershed control program, and meet the TTHM standard. If all of these criteria are met, the SWTR allows an unfiltered system to remain unfiltered if it can meet the 3log=4log treatment through disinfection alone. To ensure that the unfiltered system provides sufficient disinfection, the SWTR and associated USEPA guidance provide tables of CT values for disinfection inactivation [CT is the product of disinfectant residual concentration (C) in milligrams per liter (mg=L) and disinfectant contact time (T ) in minutes]. CT values are provided for 3log inactivation of Giardia and 4log inactivation of enteric viruses by disinfectant type (e.g., chlorine, chloramines, ozone, chlorine dioxide), water pH, and water temperature. To control Legionella and HPC, as required by the 1986 SDWA, USEPA assumed that the SWTR removal=inactivation requirements for Giardia and viruses would minimize the concentration of bacteria. Some bacterial pathogens such as Legionella, however, may flow from the distribution system to residential or office hot-water plumbing systems, and proliferate in this warm environment. On the basis of a legal interpretation, USEPA decided that it did not have the legal authority to control Legionella within plumbing systems, which are generally outside the authority of the water system. However, the Agency has issued guidance on the control of Legionella in plumbing systems (USEPA 1988).

12.5 CONTROL OF WATERBORNE PATHOGENS AND DBPs IN THE 1990s AND BEYOND In the late 1980s, USEPA had identified a number of disinfection byproducts (DBPs) other than the TTHMs. Several animal studies and epidemiology studies suggested that some disinfectants and DBPs might pose a public health risk. These included DBPs from chlorine (e.g., haloacetic acids, haloacetonitriles), from ozone (bromate, aldehydes), from chlorine dioxide (chlorite, chlorate), and from chloramines (cyanogen chloride). A major dilemma for the Agency was how to control DBP formation without compromising pathogen control. This balance became even more

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TABLE 12.4

Surface Water Treatment Rule

Turbidity

Disinfection Unfiltered Systemsa

Monitor source water turbidity at least every 4 h; samples must not exceed 5 NTU

Monitor disinfection conditions daily to calculate inactivation through the CT principle and confirm that the system is achieving at least a 3log inactivation of Giardia and a 4log inactivation of viruses Maintain a detectable disinfectant residual throughout the distribution system Have redundant disinfection components or automatic shutoff to prevent untreated water from entering the distribution system

Filtered Systems Monitor combined filter effluent turbidity at least every 4 h;b for conventional filtration and direct filtration, 95% of monthly samples must not exceed 0.5 NTU and no individual sample may exceed 5 NTU; for diatomaceous earth and slow sand filtration, 95% of monthly samples must not exceed 1 NTU and no individual sample may exceed 5 NTU; for alternative filtration technologies such as membranes or bag filters, 95% of monthly samples must not exceed 1 NTU and no individual sample may exceed 5 NTU (after the system has demonstrated that filtration and disinfection together achieve a 3log inactivation and removal of Giardia and a 4log inactivation and removal of viruses)

Monitor disinfection conditions specified by the state daily to confirm that filtration and disinfection together achieve a 3log inactivation and removal of Giardia and a 4log inactivation and removal of viruses Maintain a detectable disinfectant residual throughout the distribution system

a In addition to the requirements in this table, unfiltered systems must meet certain criteria on an ongoing basis to remain unfiltered. These include monitoring of the source water for total coliform or fecal coliform at least 5 times per week, with at least 90% of samples taken in the previous 6 months below 100=100 mL or 20=100 mL, respectively; having no more than two events in any 1-year period or five events in a 10-year period when the source water turbidity exceeds 5 NTU; developing and implementing a watershed control program to minimize the potential for source water contamination by Giardia or viruses, including a yearly on-site state inspection; and continued compliance with MCLs for total coliform and TTHM. b Small systems and certain filtration technologies qualify for less frequent monitoring.

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crucial in 1993, when a massive outbreak of waterborne cryptosporidiosis in Milwaukee became a major national news story. About 400,000 people became ill and 50 people died (MacKenzie et al. 1994). This outbreak put considerable pressure on USEPA to accelerate the development of regulations to control Cryptosporidium. In addition, the results of a survey (LeChevallier et al. 1991a) indicated significantly higher levels of Giardia in source waters used by drinking water supplies than had previously been reported. Both the outbreak and the Giardia survey data raised questions about the adequacy of the SWTR limits. Because of the technical complexity posed by the need to balance pathogen and DBP risk, and the lack of sufficient DBP occurrence, treatment, and health effects data, USEPA initiated a negotiated rulemaking in 1992 to control both types of risk. A negotiated rulemaking involves the direct participation of individuals representing different organizations with different points of view that would be affected by the rule (stakeholders). USEPA sometimes uses this rulemaking approach for the development of a complicated rule where the regulatory strategy is uncertain or where competing goals need to be met. The negotiation is conducted under the provisions of the Federal Advisory Committee Act (FACA), and the different parties attempt to reach a consensus on the provisions of the rule to be proposed. The FACA process that USEPA initiated in 1992 was the first of three related negotiated rulemakings (the two others are discussed below). In all three, the negotiators included representatives of USEPA, state, and local health and regulatory agencies, public water systems, elected state officials, consumer groups, and environmental groups. The Advisory Committee, as the negotiating team was called, met from November 1992 through June 1993. A few of the tough issues with which the Advisory Committee struggled were whether to:  Regulate DBPs through MCLs or through a treatment technique  Minimize formation of DBPs by establishing a regulatory limit for their naturally occurring organic precursors (e.g., total organic carbon) in the water before disinfection  Provide greater protection against pathogens, in conjunction with new DBP limits, by tightening the SWTR  Develop a second round of DBP controls along with the first, or to wait until better scientific information became available. Following months of intensive discussions and technical analysis, the committee recommended the development of three sets of rules: (1) a two-staged Disinfectants=Disinfection Byproduct Rule (Stage 1 DBPR and Stage 2 DBPR), (2) an ‘‘interim’’ ESWTR (IESWTR), and (3) an Information Collection Rule (ICR). The intent was to use the monitoring and treatment data that would result from the ICR to develop the IESWTR and Stage 2 DBPR. The IESWTR would apply to systems serving 10,000 people or more. The Committee also agreed that a ‘‘long-term’’ ESWTR (LT-ESWTR) would be needed for systems serving fewer

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than 10,000 people and possibly to refine requirements for larger systems based on new information. The Advisory Committee agreed that the implementation schedules for IESWTR and LTESWTR should be ‘‘linked’’ to the implementation schedule for the Stage 1 DBPR to assure simultaneous compliance. This linkage would balance the control of pathogen and DBP risk. The Committee also concluded that additional data on health risk, occurrence, and the relative efficiencies of various technologies were needed to better understand the risk tradeoff, determine the most appropriate means for accomplishing an overall reduction in risk, and support development of the IESWTR, LT-ESWTR, and Stage 2 DBPR. To meet this objective the Committee agreed that utilities would collect additional occurrence and treatment information under the ICR, and USEPA and others would conduct additional research. The three first-phase rules were proposed in 1994 to solicit public comment. The major goals and features of these three rules, as finalized, are discussed below.

12.5.1

1996 SDWA Amendments for Pathogen and DBP Control

In August 1996, before any of the new rules mentioned in the previous section (except for the ICR) could be finalized, Congress reauthorized and amended the SDWA. Among the new provisions, the 1996 amendments set a schedule for USEPA to publish the IESWTR (1998), Stage 1 DBPR (1998), LTESWTR (2001), and the Stage 2 DBPR (2002), in line with the FACA Advisory Committee recommendations. The 1996 amendments also required USEPA to publish a regulation that ‘‘governs’’ the recycle of filter backwash water within a treatment plant. This requirement was probably prompted because several outbreaks of cryptosporidiosis had occurred at drinking water systems where recycled filter backwash was identified as a possible cause (Craun 1998). Recycled filter backwash is discussed later. In addition to specific regulatory provisions, the 1996 SDWA Amendments required USEPA and CDC to conduct epidemiology studies in several communities that would provide a basis for estimating the number of cases of waterborne disease occurring each year in the United States. This requirement may have been prompted by the size of the Milwaukee outbreak of cryptosporidiosis as well as the results of two epidemiology studies in Canada. One epidemiology study indicated that, for a well-treated system using a poor-quality source water, about one-third of the cases of gastrointestinal illness were drinking-water-related (Payment et al. 1991). A follow-up epidemiology study at this system, using a different approach, resulted in similar findings (Payment et al. 1997). The 1996 SDWA amendments also required USEPA to publish a list of unregulated contaminants every 5 years that are known or anticipated to occur in water systems and that may need to be regulated. The first list, known as the Contaminant Candidate List (CCL), was published on March 2, 1998 (USEPA 1998a). The purpose of the CCL is to determine which unregulated drinking water contaminants should be given high priority for research and regulatory consideration. According to the amendments, USEPA is to select at least five contaminants from the CCL

12.5 CONTROL OF WATERBORNE PATHOGENS AND DBPs IN THE 1990s

TABLE 12.5

293

Pathogens on the Contaminant Candidate List

Protozoa Acanthamoeba Microsporidium [Enterocytozoon, Encephalitozoon (formerly Septata)] Viruses Caliciviruses Adenoviruses Coxsackieviruses Echoviruses Bacteria Helicobacter pylori Mycobacterium avium complex Aeromonas hydrophila Algae Algae and their toxins

every 5 years and determine whether to regulate them. Ten pathogens were included on the 1998 CCL (see Table 12.5). The FACA recommendations mentioned previously were modified somewhat by a major technical difficulty. The original intent was to use the ICR monitoring and treatment data to revise the SWTR (IESWTR and LTESWTR) and to develop the Stage 2 DBPR. However, because the analytical method for Giardia and Cryptosporidium performed below expectations, publication and implementation of the ICR stalled while a concerted effort was made to improve method performance. The delay complicated the planned regulatory phasing approach, and led to USEPA separating the LTESWTR into two parts: the LT1ESWTR, which would not be based on ICR data, and LT2ESWTR, which would be based on these data. The regulations are described below.

12.5.2

Information Collection Rule (ICR)

The purpose of the ICR (USEPA 1996), published in May 1996, was to collect occurrence and treatment information needed to develop the LT2ESWTR and Stage 2 DBPR. The ICR generally covered systems serving at least 100,000 people, although a more limited set of ICR requirements applied to groundwater systems serving between 50,000 and 100,000 people. About 300 systems operating 500 treatment plants were involved with the extensive ICR data collection. The ICR required surface water systems to collect source water samples, and in some cases finished water samples, monthly for 18 months, and test them for the following organisms: Giardia, Cryptosporidium, viruses, total coliforms, and fecal coliforms or E. coli. The ICR also required systems serving at least 100,000 people to determine the concentrations of a host of disinfectant and DBP concentrations in water from different parts of the system. Besides valuable occurrence data, the rule

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required systems to provide specified system operating and engineering data to USEPA. In addition, depending on the TOC levels in their source or finished water, systems were required to conduct bench- or pilot-scale studies with granular activated carbon or membranes to evaluate their effectiveness in controlling TTHMs and haloacetic acids. The data collected under the ICR, with new information that became available through other surveys and research, allowed USEPA to identify strategies for minimizing DBP formation, determine appropriate treatment levels to protect against pathogens, and estimate how much it would cost utilities nationwide to implement various regulatory options. ICR monitoring began in July 1997 and ended in early 1999. 12.5.3

Stage 1 Disinfection Byproducts Rule (DBPR)

USEPA established a second FACA Advisory Committee in March 1997 to collect, share, and analyze information and data developed after the 1994 proposal, as well as build consensus on the implications of this new information. In July 1997, the Advisory Committee reached agreement on the following major issues related to DBPs: (1) set MCLs for TTHM, five haloacetic acids (HAA5), chlorite, and bromate; (2) specified enhanced coagulation requirements as part of DBP control (Advisory Committee suggested modifications in the proposed requirement, based on new data on coagulation effectiveness and the prevalence and multiple uses of predisinfection); and (3) included a methodology by which a surface water system that was likely to modify its disinfection practices, after consulting with the state, could assure that pathogen control would not be significantly degraded as the result of modifying disinfection practices to meet MCLs for TTHM and HAA5 (this requirement appeared in the IESWTR and LT1ESWTR). USEPA published a summary of the Advisory Committee’s recommendations (USEPA 1997a). In 1998, USEPA published the Stage 1 DBPR (USEPA 1998c), which applies to all CWSs and nontransient NCWSs that add a disinfectant during any part of the treatment process (including as a residual). In addition, transient NCWSs that use chlorine dioxide were required to control the level of chlorine dioxide entering the distribution system because of concerns about short-term health effects. The Stage 1 DBPR included a total of 11 nonenforceable MCLGs and seven enforceable MCLs or maximum residual disinfectant levels (MRDLs). Among the provisions, the rule reduced the MCL for TTHMs from the 1979 standard of 0.10 to 0.080 mg=L. Table 12.6 provides a summary of the MCLGs and MCLs in the Stage 1 DBPR. In addition to the MCLs and MRDLs, the Stage 1 DBPR set a treatment technique to reduce the formation of unregulated DBPs in systems that were most likely to have higher levels of these DBPs. This treatment technique required conventionally treated surface water systems to remove specified amounts of organic materials [measured as total organic carbon (TOC)], using enhanced coagulation or enhanced softening. Table 12.7 contains the basic TOC removal requirements, with compliance based on a running annual average. Systems could avoid this TOC removal requirement if (1) the source water had low TOC levels, (2) enhanced

12.5 CONTROL OF WATERBORNE PATHOGENS AND DBPs IN THE 1990s

295

TABLE 12.6 MRDLGs, MRDLs, MCLGs, and MCLs in Stage 1 Disinfection Byproduct Rule Disinfectant

MRDLG (mg=L) MRDL (mg=L)

Chlorine

4 (as Cl2)

4.0 (as Cl2)

Chloramines

4 (as Cl2)

4.0 (as Cl2)

0.8 (as ClO2)

0.8 (as ClO2)

Chlorine dioxide (at treatment plants using ClO2) Disinfection Byproduct Total trihalomethanes (TTHM) consisting of Chloroform Bromodichloromethane Dibromochloromethane Bromoform Haloacetic acids (five) (HAA5) consisting of Monochloroacetic acid Dichloroacetic acid Trichloroacetic acid Monobromoacetic acid Dibromoacetic acid Bromate (at treatment plants using ozone) Chlorite (at treatment plants using ClO2)

MCLG (mg=L)

MCL (mg=L)

NA

0.080

—a 0 0.06 0 NA

NA NA NA NA 0.060

— 0 0.3 — — 0

NA NA NA NA NA 0.010

0.8

1.0

Compliance Based on Running annual average of distribution system samples Running annual average of distribution system samples Individual samples taken at the treatment plant or in the distribution system Compliance Based on Running annual average of all distribution system samples; sample value is the sum of the four individual THMs Running annual average of all distribution system samples; sample value is the sum of the five individual HAAs Running annual average of samples at treatment plant Average of distribution system three-sample sets taken at least monthly

a

USEPA proposed and finalized an MCLG of zero for chloroform. The U.S. Court of Appeals for the District of Columbia vacated the MCLG and remanded it to USEPA for action.

coagulation was ineffective in removing the TOC, or (3) the TOC was relatively nonreactive with chlorine. The TOC removal requirement was limited to conventionally treated surface water systems because (1) such systems generally had higher precursor levels and DBP levels than did systems using other technologies and (2) the process was relatively inexpensive for conventionally treated systems but expensive and technologically less practical for other types of systems (e.g., in a direct filtration system, which does not use the sedimentation step, the higher coagulant

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TABLE 12.7 Required TOC Removal by Enhanced Coagulation=Enhanced Softening for Surface Water Systems Using Conventional Treatmenta,b Source Water Alkalinity, mg=L as CaCO3 (%) Source Water TOC (mg=L)

0–60

>60–120

>120

>2.0–4.0 >4.0–8.0 >8.0

35.0 45.0 50.0

25.0 35.0 40.0

15.0 25.0 30.0

a b

Softening systems must meet the TOC removal requirements in the right-hand column. Also applies to utilities that treat groundwater under the influence of surface water.

doses needed for enhanced filtration would overload the filter). By using the enhanced coagulation or enhanced softening process, a system would have less precursor material to react with chlorine and thus would have less reason to switch from chlorine to an alternative disinfectant. Switching disinfectant was a concern because even less was known about the health effects associated with DBPs from these alternative disinfectants than was known about chlorinated DBPs. As stated previously, the SDWA requires USEPA to take implementation costs into account in setting an MCL. This means that the Agency cannot set an MCL that a system is not able to consistently meet using the ‘‘best available technology’’ (BAT) that is affordable. In setting an MCL, USEPA must identify an affordable BAT. For the Stage 1 DBPR, the BAT for each MCL (or MRDL) is indicated in Table 12.8. USEPA was aware of technologies that, if implemented, would produce lower levels of DBPs; however, their costs (especially for small systems without economies of scale) were not considered affordable. Because of the complexity of the rule and the need to balance risks and achieve simultaneous compliance with multiple rules, USEPA developed guidance for both systems and states for implementation of the rule (as was also done with the IESWTR). The guidance documents included ones addressing enhanced coagulation and softening, alternative disinfectants, and simultaneous compliance.

12.5.4 Strengthening the SWTR: The IESWTR, LT1ESWTR, and Filter Backwash Recycling Rule The same FACA Advisory Committee that helped develop the Stage 1 DBPR also assisted in the development of a revision to the SWTR, known as the IESWTR. In July 1997, the Advisory Committee reached agreement on IESWTR criteria. The final rule was published in 1998 (USEPA 1998d). The IESWTR applies to systems covered by the SWTR (systems using surface water or groundwaters under the direct influence of surface water) that serve 10,000 people or more. The centerpiece of the revision was to require a 2log Cryptosporidium removal. For systems using rapid granular filtration (i.e., filtration as used in conventional treatment or direct filtration), the turbidity standard was

12.5 CONTROL OF WATERBORNE PATHOGENS AND DBPs IN THE 1990s

TABLE 12.8

297

BAT for Disinfectants and Disinfection Byproducts

Disinfectant=DBP

Best Available Technology Disinfectants

Chlorine residual

Chloramine residual

Chlorine dioxide residual

Control of treatment processes to reduce disinfectant demand and control of disinfection treatment processes to reduce disinfectant levels Control of treatment processes to reduce disinfectant demand and control of disinfection treatment processes to reduce disinfectant levels Control of treatment processes to reduce disinfectant demand and control of disinfection treatment processes to reduce disinfectant levels Disinfection Byproducts

Total trihalomethanes Total haloacetic acids Chlorite

Bromate

Enhanced coagulation or GAC10,a with chlorine as the primary and residual disinfectant Enhanced coagulation or GAC10, with chlorine as the primary and residual disinfectant Control of treatment processes to reduce disinfectant demand and control of disinfection treatment processes to reduce disinfectant levels Control of ozone treatment process to reduce production of bromate

a GAC10 means granular activated carbon with an empty-bed contact time of 10 minutes and reactivation frequency for GAC within at least 6 months.

tightened, and continuous turbidity monitoring was required for individual filters. Under the IESWTR, if the turbidity of an individual filter exceeds USEPA-specified performance levels, the system is required to evaluate and correct the deficiency of the filter. The major features of the IESWTR are indicated in Table 12.9. The IESWTR supplemented, but did not replace, the SWTR. Some systems, especially smaller ones using relatively clean source water, use other filter processes such as slow sand filtration or diatomaceous earth filtration. The IESWTR did not change the existing turbidity performance criteria for these systems because data indicated that these filter processes, as prescribed under the SWTR, already achieve at least a 2log Cryptosporidium removal. The IESWTR also modified the criteria for avoiding filtration by requiring the watershed control program to control for Cryptosporidium (but did not change the existing SWTR criteria for avoiding filtration), because available occurrence data suggested that Cryptosporidium densities in the raw water of unfiltered systems were similar to those in the finished water of many filtered systems. The IESWTR did not require, or provide an option for, Cryptosporidium monitoring in the source water,

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TABLE 12.9 Interim Enhanced Surface Water Treatment Rule (IESWTR)a Profiling and Benchmarking Systems judged to be most likely to modify their disinfection practices to comply with the Stage 1 DBPR (defined as those with TTHM or HAA5 running annual averages exceeding 0.064 and 0.048 mg=L, respectively) were required to determine the level of Giardia (and, in some cases, virus) inactivation daily for one year; before modifying disinfection practices, systems were required to consult with the state to ensure that modifications would result in no significant increase in microbial risk Combined Filter Effluent Turbidity For systems using conventional filtration or direct filtration, 95% of samples taken during the month cannot exceed 0.3 NTU, and no individual sample can exceed 1 NTU; diatomaceous earth and slow sand filtration must continue to meet the SWTR standards (Table 12.4); systems using alternative filtration technologies must demonstrate that the technology achieves a 2log removal of Cryptosporidium and meet state-specified turbidity limits Individual Filter Monitoring Systems using conventional filtration or direct filtration must monitor the turbidity of each individual filter every 15 min; if certain triggers indicating poor or degraded filter performance are exceeded, systems must conduct actions designed to improve performance a

With the exception of the combined filter effluent turbidity provisions for conventional filtration and direct filtration, requirements in this table are in addition to SWTR requirements listed in Table 12.3.

because analytical methods were not yet available for making adequately accurate determinations. At the beginning of the rule development process to control Cryptosporidium, it was thought that this microbe was exceptionally resistant to disinfectants, with the possible exception of ozone. Later, new animal study data suggested that this view was too pessimistic. Nevertheless, the IESWTR required that filtration alone provide the 2log Cryptosporidium reduction, rather than a combination of filtration and disinfection. At the time the IESWTR was finalized, USEPA did not have criteria (such as CT values) for estimating inactivation of Cryptosporidium by effective technologies such as ozone and ultraviolet light. The IESWTR also set constraints on systems that might want to cut back the existing disinfection process to comply with DBPR limits. The system must first evaluate the effect on Giardia and viral control of any proposed change to a disinfection practice (referred to as disinfection profiling and benchmarking), and satisfy the state that the proposed changes in treatment would not significantly undermine existing pathogen control.

12.5 CONTROL OF WATERBORNE PATHOGENS AND DBPs IN THE 1990s

299

The IESWTR included another provision requiring states to conduct on-site sanitary surveys for all surface water systems. The requirement, which was more specific than the sanitary survey requirement in the TCR, stipulated that sanitary surveys had to include an evaluation of source water quality, treatment, distribution system, finished water storage, pumping facilities, monitoring and reporting data, system management and operation, and operator compliance with state requirements. While most states have had a sanitary survey program in place for many years, these programs often differed significantly among the states with regard to content or frequency. The overall purpose of the IESWTR provisions was to tighten pathogen control from source to tap, thereby minimizing the potential for waterborne disease. Subsequent to publishing the IESWTR, USEPA published the Long Term 1 Enhanced SWTR (LT1ESWTR) (USEPA 2002). The LT1ESWTR extended coverage of the IESWTR to surface water systems serving fewer than 10,000 people. The LT1ESWTR has basically the same requirements as the IESWTR, except that the turbidity of individual filters must be analyzed less often and less monitoring is required to establish the disinfection benchmark. Another modification to the SWTR is the Filter Backwash Recycling Rule (FBRR) (USEPA 2001). As part of normal maintenance of the filtration process, a filter is periodically taken off line and cleaned by reversing the water flow, or backwashed. The backwash process usually involves a large volume of water flowing through the filter. Typically, the backwashed water is directed to the plant influent water or to a specific location in the treatment process. Thus, any pathogens in the backwashed water may be returned to the system. If the point of backwash recycling is not at the beginning of the treatment process, pathogen removal may be compromised. Moreover, when the large volume of backwash water enters a point in the treatment process other than at the initial treatment stage, where it can be distributed as part of the entire plant influent, the combined normal influent water and the recycling backwash water may create a hydraulically overloaded condition, particularly for small systems, that could overwhelm existing treatment. These two situations could degrade Cryptosporidium removal efficiency. To prevent this problem, USEPA published the FBRR, as mandated by the 1996 SDWA amendments. The FBRR requires (with some exceptions) a system using either conventional or direct filtration to recycle backwash water so that it passes through the entire existing treatment process, rather than at an intermediate point where the backwash water would receive incomplete treatment. The rule also ensures that systems and states will have the recycle flow information necessary to evaluate whether a site-specific backwash recycle practice might compromise a system’s ability to achieve the required 2log Cryptosporidium removal. 12.5.5

Ground Water Rule

USEPA is currently developing a regulation that would require an undisinfected groundwater system to assess whether its source water is at high risk for fecal

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CONTROL OF DRINKING WATER PATHOGENS AND DISINFECTION BYPRODUCTS

contamination and, if so, to undertake corrective action. In 2000, (USEPA 2000a), USEPA proposed a regulation known as the Ground Water Rule (GWR) that included the following provisions: (1) a periodic state-conducted sanitary survey for every system and a requirement to correct each significant deficiency identified, (2) an initial phase of source water monitoring by undisinfected systems using a fecal indicator (such as E. coli, enterococci, or coliphage), and (3) for each undisinfected system, an assessment of the hydrogeological characteristics to gauge whether the source water might be vulnerable to fecal contamination. A high-risk system would be required to disinfect or provide some other means of protecting the public. Under the GWR, as proposed, a high-risk system that disinfects would be required to consistently achieve a 4log (99.99%) virus inactivation. The GWR is being developed in response to the 1996 SDWA amendments, which directed USEPA to publish regulations requiring all groundwater systems to determine whether they needed to disinfect. The SWTR already requires systems using surface water or groundwaters under the direct influence of surface water to disinfect. 12.5.6

LT2ESWTR and Stage 2 DBPR

In March 1999, USEPA reconvened the FACA Advisory Committee to develop recommendations for the LT2ESWTR and Stage 2 DBPR. The intent is to implement the two rules simultaneously for the same reason that the IESWTR was linked with the Stage 1 DBPR, i.e., to prevent a system from compromising pathogen control to meet new DBPR requirements. USEPA expects to propose these recommendations during 2003 and finalize them in 2004. The primary goal of the LT2SWTR is to modify the SWTR such that the public health risk of waterborne cryptosporidiosis would be equivalent, that is, that the required treatment level would depend on the density of Cryptosporidium in the source water. This goal is supported by data from the ICR and supplemental surveys that indicated that mean pathogen levels in different source waters of filtered systems could vary by several orders of magnitude and that minimum treatment levels prescribed by the IESWTR and LT1ESWTR would seldom result in comparable levels of protection across systems. The new occurrence data also indicated that Cryptosporidium densities in the raw water of unfiltered systems were substantially higher than the finished water of most filtered systems. To address these issues, a filtered system using a poor-quality source water would need more treatment than those using a good-quality source water. Also, unfiltered systems, in general, while continuing to meet the filtration avoidance criteria, would need some minimum level of inactivation for Cryptosporidium to achieve comparable protection to filtered systems. The Advisory Committee recommended the following provisions for LT2ESWTR: (1) an initial round of Cryptosporidium monitoring in source waters over a period of 1 year (small systems) or 2 years (large systems) to determine appropriate levels of treatment; (2) a ‘‘toolbox’’ of technologies from which systems could choose to provide additional treatment for Cryptosporidium; (3) an option for small systems to monitor the E. coli density in source water, in lieu of Cryptosporidium, to determine whether Cryptosporidium monitoring and possible

12.6 A VIEW TOWARD THE FUTURE

301

additional treatment was needed; (4) a minimum 2log Cryptosporidium inactivation requirement for unfiltered systems; and (5) specific operational and design criteria for ultraviolet light that would allow its use as an option for providing additional treatment for Cryptosporidium control. In addition, the Advisory Committee recommended that 6 years following the completion of the initial source water monitoring, systems be required to conduct a second round of monitoring to determine possible changes in the source water quality and associated treatment. The goal of the Stage 2 DBPR is to more tightly control the formation of DBPs by setting concentration limits at specific points in the distribution system, rather than more general limits as is the case with the Stage 1 DBPR. This goal is supported by ICR data indicating that TTHM and HAA5 levels could greatly exceed the Stage 1 MCL at various locations within the distribution system and that the highest levels of TTHM and HAA5 rarely occur at the same locations or at the maximum residence times (as had been assumed under the Stage 1 MCL). The Advisory Committee thus recommended the following provisions for the Stage 2 DBPR: (1) retain the MCLs for TTHMs and HAA5 at 0.080 and 0.060 mg=L, respectively, but revise the compliance calculation from a running annual average of measurements throughout the distribution system to a running annual average at each site within the distribution system; and (2) identify the monitoring sites within the distribution system that have the highest TTHM and HAA5 concentrations, and then retain these sites as monitoring locations. USEPA believes that these rule modifications will reduce cancer risks and adverse developmental and reproductive effects, and minimize differences in protection among the population served, regardless of where in the distribution system water is obtained.

12.6

A VIEW TOWARD THE FUTURE

As a new century begins, U.S. drinking water is much safer than ever before. Since the early 1990s, USEPA has published new regulations to control pathogens more tightly and to minimize the formation of harmful DBPs. These regulations are the SWTR, as revised, TCR, and Stage 1 DBPRs. The emphasis for pathogen control has been on setting treatment requirements and using easily measured indicators of water quality and other measures (e.g., periodic sanitary surveys) to assess the adequacy and reliability of that treatment. The regulatory focus of DBP control has been through MCLs. Yet challenges remain. The quality of source waters may degrade with population increases, complicating water treatment and prompting direct water reuse. Newly discovered deficiencies in the distribution system are complicating control of distribution system integrity. The adequacy of current and impending regulations for the control of emerging pathogens is an issue. Beyond the technical challenges, media attention on actual or perceived deficiencies in public water supplies, along with highly visible waterborne disease outbreaks, have resulted in some public anxiety about the quality of our drinking water. The use of bottled water has increased markedly over a short period of time.

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The challenge is to allay this concern, not through overregulation, but by using a systems management strategy for providing microbially safe drinking water. This strategy encompasses the multibarrier approach for pathogen control: watershed control to minimize pathogen introduction to surface waters and groundwaters used by water supplies, adequate and reliable water treatment, and proper operation and maintenance of the distribution system. It also includes operator training, periodic on-site inspections by the state, and laboratory accreditation. The complexity and expanse of this challenge is requiring USEPA to work closely with states and the regulated community in developing new drinking water regulations. Research is an important element in developing a scientifically defensible, costeffective regulation. For an emerging pathogen, the specific research data needed varies with the pathogen (CCL pathogens are presented in Table 12.5), but generally data are needed to address the following questions: To what extent will existing or forthcoming regulations address an emerging pathogen? To what extent does the pathogen occur in source waters or grow within the distribution system? What is the health risk associated with a pathogen, especially in sensitive subpopulations? How effective are various water treatment processes in controlling a pathogen? How effective are various operational and maintenance procedures associated with the distribution system for controlling a pathogen? For DBPs, issues include the relative significance of developmental and reproductive effects associated with DBPs and, if these effects are significant, which DBPs are of most concern and how they can best be controlled. Much of this research is under way.

REFERENCES Bellar, T. A., J. J. Lichtenberg, and R. C. Kroner. 1974. The occurrence of organohalides in chlorinated drinking water. J. Am. Water Works Assoc. 66(12):703–706. Bennett, J. V., S. D. Holmberg, M. F. Rogers, and S. L. Solomon. 1987. Infectious and parasitic diseases. In Closing the Gap: The Burden of Unnecessary Illness. R. W. Amler and H. B. Dull, eds. New York: Oxford Univ. Press. Christian, R. and W. Pipes. 1983. Frequency distribution of coliforms in water distribution systems. Appl. Environ. Microbiol. 45:603–609. Committee on Public Health Activities. 1961. Coliform organisms as an index of water safety. J. Sanitary Eng. Div. ASCE 87(SA6):41–58. Congress. 1976. House of Representatives Report 93-1185 (from 93rd Congress, 2nd session, on Safe Drinking Water Act). Washington, DC: U.S. Government Printing Office. Craun, G. F. 1988. Surface water supplies and health. J. Am. Water Works Assoc. 80(2):40–52.

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Craun, G. F. 1998. Memorandum from G. Craun to U.S. Environmental Protection Agency (M. Negro), dated 10=26=98. Waterborne outbreak data 1971–1996, community and noncommunity water systems. Du Moulin, G. C., and K. D. Stottmeier. 1986. Waterborne mycobacteria: An increasing threat to health. ASM News 52:525–529. Geldreich, E. E. 1966. Sanitary significance of fecal coliforms in the environment. Water Pollution Control Research Series Publication WP-20-3. Cincinnati: U.S. Dept. Interior, Federal Water Pollution Control Administration. Harter, L. et al. 1985. A three-state study of waterborne disease surveillance techniques. Am. J. Public Health 75:1327–1328. Kabler, P. W. and H. F. Clark. 1960. Coliform group and fecal coliform organisms as indicators of pollution in drinking water. J. Am. Water Works Assoc. 52:1577–1579. LeChevallier, M. W., D. N. Norton, and R. G. Lee. 1991a. Occurrence of Giardia and Cryptosporidium spp. in surface water supplies. Appl. Environ. Microbiol. 57:2610–2616. LeChevallier, M. W., D. N. Norton, and R. G. Lee. 1991b. Giardia and Cryptosporidium spp. in filtered drinking water supplies. Appl. Environ. Microbiol. 57(9):2617–2621. MacKenzie, W. R., N. J. Hoxie, M. E. Proctor, M. S. Gradus, K. A. Blair, D. E. Peterson, J. J. Kazmierczak, D. A. Addiss, K. R. Fox, J. B. Rose, and J. P. Davis. 1994. A massive outbreak in Milwaukee of Cryptosporidium infection transmitted through the public water supply. New Engl. J. Med. 331(3):161–167. Macler, B. and S. Regli. 1993. Use of microbial risk assessment in setting US drinking water standards. Internat. J. Food Microbiol. 18:245–256. McCabe, L. J., J. M. Symons, R. G. Lee, and G. G. Robeck. 1970. Survey of community water supply systems. J. Am. Water Works Assoc. 62:670–687. McDermott, J. H. 1973. Federal drinking water standards—past, present and future. J. Environ. Eng. Div. ASCE (Proc. Paper 9924), 99(EE4):469–478. Morris, R. D. et al. 1992. Chlorination, chlorination by-products, and cancer: a meta-analysis. Am. J. Public Health 82(7):955–963. NRC. 1977. Drinking Water and Health. Washington, DC: National Academy Press. Payment, P. 1981. Isolation of viruses from drinking water at the Pont-Viau water treatment plant. Can. J. Microbiol. 27:417–420. Payment, P., L. Richardson, J. Siemiatycki, R. Dewar, M. Edwardes, and E. Franco. 1991. A randomized trial to evaluate the risk of gastrointestinal disease due to consumption of drinking water meeting current microbiological standards. Am. J. Public Health 81:703–708. Payment, P., J. Siemiatycki, L. Richardson, G. Renaud, E. Franco, and M. Prevost. 1997. A prospective epidemiological study of gastrointestinal health effects due to the consumption of drinking water. Internat. J. Environ. Health Research 7:5–31. Pipes, W., and R. Christian. 1982. Sampling Frequency—Microbiological Drinking Water Regulation. EPA 570=9-82-001. Washington, DC: USEPA. Pontius, F. W. and S. W. Clark. 1999. Drinking water quality standards, regulations, and goals. In Water Quality and Treatment, 5th ed. R. D. Letterman, ed. New York: McGraw-Hill. Regli, S., A. Amirtharajah, B. Borup, C. Hibler, J. Hoff, and R. Tobin. 1988. Panel discussion on implications of regulatory changes for water treatment in the United States. In Advances in Giardia Research. P. M. Wallace and B. R. Hammond, eds. Calgary: Univ. Calgary Press.

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Reif, J. S. et al. 1996. Reproductive and developmental effects of disinfection by-products in drinking water. Environ. Health Perspect. 104(10):1056–1061. Rook, J. J. 1974. Formation of haloforms during chlorination of natural waters. Water Treat. Exam. 23:234. SDWA 1974. Safe Drinking Water Act (Public Law 93–523). Symons, J. M., T. A. Bellar, J. K. Carswell, J. Demarco, K. L. Kropp, G. G. Robeck, D. R. Seeger, C. L. Slocum, B. Smith, and A. A. Stevens. 1975. National Organics Reconnaissance Survey for Halogenated Organics. J. Am. Water Works Assoc. 67(11):634–647. USEPA. 1975. National Interim Primary Drinking Water Regulations. Fed. Reg. 40:59566–59588. USEPA. 1978. National Organics Monitoring Survey (NOMS). Cincinnati: Office of Ground Water and Drinking Water, Technical Support Division. USEPA. 1979. National Interim Primary Drinking Water Regulations; Control of Trihalomethanes in Drinking Water. Fed. Reg. 44:68624. USEPA. 1983. National Primary Drinking Water Regulations: Advanced Notice of Proposed Rulemaking. Fed. Reg. 48:45502–45521. USEPA. 1985. National Primary Drinking Water Regulations; Synthetic Organic Chemicals, Inorganic Chemicals and Microorganisms; Proposed Rule. Fed. Reg. 50:46936–47022. USEPA 1988. Control of Legionella in plumbing systems. In Reviews of Environmental Contamination and Toxicology 107:79–92. G. W. Ware (ed.), New York: Springer-Verlag. USEPA. 1989a. National Primary Drinking Water Regulations; Filtration, Disinfection; Turbidity, Giardia lamblia, Viruses, Legionella, and Heterotrophic Bacteria; Final Rule. Part II. Fed. Reg. 54:27486. USEPA. 1989b. National Primary Drinking Water Regulations; Total Coliforms (Including Fecal Coliform and E. coli); Final Rule. Fed. Reg. 54:27544. USEPA. 1994a. National Primary Drinking Water Regulations; Disinfectants and Disinfection Byproducts; Proposed Rule. Fed. Reg. 59:38668. USEPA. 1994b. National Primary Drinking Water Regulations; Enhanced Surface Water Treatment Requirements; Proposed Rule. Fed. Reg. 59(145):38832. USEPA. 1994c. National Primary Drinking Water Regulations; Monitoring Requirements for Public Drinking Water Supplies; Proposed Rule. Fed. Reg. 59(28):6332. USEPA. 1996. National Primary Drinking Water Regulations: Monitoring Requirements for Public Drinking Water Supplies; Final Rule. Fed. Reg. 61:24354. USEPA. 1997a. National Primary Drinking Water Regulations; Disinfectants and Disinfection Byproducts; Notice of Data Availability; Proposed Rule. Fed. Reg. 62:59388–59484. USEPA. 1997b. National Primary Drinking Water Regulations: Interim Enhanced Surface Water Treatment Rule Notice of Data Availability. Fed. Reg. 62:59486. USEPA. 1998a. Announcement of the Drinking Water Contaminant Candidate List; Notice. Fed. Reg. 63:10273–10287. USEPA. 1998b. National Primary Drinking Water Regulations; Disinfectants and Disinfection Byproducts; Notice of Data Availability; Proposed Rule. Fed. Reg. 63:15606–15692. USEPA. 1998c. National Primary Drinking Water Regulations. Disinfectants and Disinfection Byproducts. Final Rule. Fed. Reg. 63:69390–69476 (http:==www.epa.gov=safewater= mdbp=dpbfr.pdf).

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USEPA. 1998d. National Primary Drinking Water Regulations. Interim Enhanced Surface Water Treatment Rule. Final Rule. Fed. Reg. 63:38832–38858 (http:==www.epa.gov= safewater=mdbp=ieswtrfr.pdf). USEPA. 2000a. National Primary Drinking Water Regulations: Ground Water Rule. Proposed Rule. Fed. Reg. 65:30193–30274. USEPA. 2000b. Stage 2 Microbial and Disinfection Byproducts Federal Advisory Committee Agreement in Principle. Fed. Reg. 65:83015–83024 (http:==www.epa.gov=fedrgstr= epa-water=2000=december=day-29=w3306=htm). USEPA. 2001. National Primary Drinking Water; Filter Backwash Recycling Rule; Final Rule. Fed. Reg. 66:31085–31105 (http:==www.epa.gov=safewater=mdbp=fr-fbr.html). USEPA. 2002. National Primary Drinking Water Regulations: Long Term 1 Enhanced Surface Water Treatment Rule. Final Rule. Fed. Reg. 67:1812–1844. (http:==www.epa.gov= safewater=mdbp=lt1eswtr.html) USPHS. 1962. Part 72B Interstate quarantine. Fed. Reg. 27:2152–2155. USPHS. U.S. Public Health Service. 1943. Public Health Service drinking water standards. J. Am. Water Works Assoc. 35:93–103. Woodward, R. 1959. Sampling Frequency. Report of the first meeting, Advisory Committee on Revision of the Public Health Service Drinking Water Standards (met March 24–25, 1959, Washington, DC), pp. 29–37. Bureau of State Services, Public Health Service, U.S. Dept. of Health, Education, and Welfare.

13 REGULATING RADIONUCLIDES IN DRINKING WATER DAVID R. HUBER Regulation Manager, Office of Ground Water and Drinking Water, U.S. Environmental Protection Agency, Washington, DC

13.1

INTRODUCTION

Radiation is an ominous word to most people, one that evokes a wide spectrum of thoughts and emotions, both rational, and not so rational. A multitude of different, sometimes conflicting images born of the times, of ignorance, of fact, of history, may come to mind: missiles and mushroom clouds; the Manhattan Project; mutual assured destruction (MAD) policy; Yucca Mountain waste disposal; civil defense; cold war; clandestine technology; cancer cause, cancer cure; cosmic radiation; cheap energy; Chernobyl and Three Mile Island crises; X rays; fallout; and radium wristwatch dials. As a result, regulating radioactivity in drinking water is not a simple, purely rational, linear process, involving, as it does, new, changing scientific data, power politics, differing philosophical opinions and perceptions of risk, competing interagency views and policies, cost considerations, and statutory mandates. All people are exposed to radiation, both consciously and unconsciously, voluntarily or involuntarily. Some is natural, background radiation from cosmic rays, radon, and other naturally occurring radionuclides in food, air, or water, and some is created by human technology. Limitations to radioactivity exposure by the public have been established by regulating drinking water, limiting medical exposure, and waste disposal. Informing the public of risks from natural sources enables people to make reasonable choices concerning their health. But because of the significance of unavoidable natural exposures to radiation, some ask whether health risk reduction dollars could be spent more wisely in other arenas (such as highway safety or vascular disease research) where there is higher fatality, than by governmental limits in certain media such as drinking water. Drinking Water Regulation and Health, Edited by Frederick W. Pontius. ISBN 0-471-41554-5 # 2003 John Wiley & Sons, Inc.

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However, simply rank ordering and informing the public of the relative magnitudes of the risks to which they are exposed does not always add value to the debate on limiting today’s contaminant of concern. Comparisons between familiar risks and unfamiliar risks using quantitative statistical expressions can be misleading (Powell 1996). It can reduce risk to a single dimension, usually death, and trivialize the individual components of risk perception. While rank ordering risks, benefits, and costs can place hazards in a useful context for comparison, this approach is unsatisfactory because risk and responses to it are multifaceted. Some people object to smoking limitations or seat belt and helmet laws as infringing on individual liberties, while others point out that some choices affect others’ welfare and wallets. Congress has mandated protection from contaminants in public drinking water systems but not from non-public systems, such as private wells. Public drinking water systems are those which serve at least 25 people or 15 service connections for at least 60 days per year and may be publicly or privately owned. Still, limiting risk to reasonable levels in this population will be viewed as a benefit by some systems and individuals, and perceived as an unnecessary expense by others. Radium is perceived as benign by some simply because it is natural, yet it evokes profound concern in others. Relative to other accepted everyday risks we face from transportation accidents, beestings, storms, or acts of violence, sedentary lifestyles and fatty foods, smoking, and recreational sports, radiation may seem inherently more mysterious and ominous and therefore riskier. The commonness of certain events or activities may lull us into complacently accepting their risks, or else we are informed and inspired to make changes to avoid their risks. Whatever is outside of our own control, we may want ‘‘fixed’’ by someone else (i.e. the government). The choice or control over risk exposure sometimes defines the difference in concern. A risk imposed without consent (contamination of drinking water) can be of more concern than a voluntarily chosen risk (eating hamburgers and fries). The author has spoken to two pack-a-day smokers very concerned about the possibility of exposure to household radon. Perhaps it was that added risk that was of concern, but the fact that it was radiation made it seem a more real and potent threat. Exposure to diagnostic X rays may cause a modicum of concern, but it is viewed as conscious, voluntary, and necessary, while radiation risks from choosing to live a mile high in Denver, Colorado, may simply go unnoticed due to lack of knowledge, or accepted as a rational tradeoff considering other benefits. Exposure to natural radiation from a house built of brick with the latest granite countertops or floor tiles and rock fireplace may not register as being any risk at all. Radon gas in the house, though, may evoke a high degree of concern, whereas outdoor exposure to radon or cosmic rays may not be even considered. In fact, psychological research has uncovered some 47 elements influencing risk perception (Covello 1992, 1983). Slovic (1986) has identified fright, outrage, or dread factors that color perceptions of risk and make it less acceptable. For example, anxiety rises if risk is involuntary, seen as inequitable, inescapable, is novel or unfamiliar, is man-made rather than natural, is hidden and causes irreversible

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damage, is a danger to children and future generations, arouses dread, produces identifiable victims (catastrophic group disaster e.g. airline crash), appears poorly understood by science, and elicits contradictory statements from responsible sources. Covello and Merkhofer (1994) also add to the above such factors as institutional trust, media attention, accident history, clarity of benefits, reversibility, personal controllability, personal stake and attributability to the list. In the area of risk communication, it is axiomatic that perception is reality. The message sent is not necessarily the message received. Personal filters from nature and nurture color perceptions of a person’s environment. Explaining the government’s best intentions during a rulemaking is fraught with communication risks. The government operates largely under the precautionary principle: better safe than sorry. But the question is how much risk insurance are people willing to pay for. An ounce of prevention is worth a ton of cure, yet to some people, for some contaminants, the expression is turned on its head: an ounce of perceived risk is not worth a ton of prevention dollars. Sandman (1987) states that the public sees risk as more than hazard. It includes other factors such as dread, outrage, fairness and control. ‘‘The public’’, he says, ‘‘pays too little attention to hazard, the experts pay absolutely no attention to outrage’’. While a scientific assessment of risk as described by NRC (1983) entailing exposure evaluation, hazard identification, dose response and finally a risk characterization, may not take into account outrage, regulators and risk managers must pay attention to both. As discussed in this chapter, USEPA had to balance the desire for absolute minimal risk from some citizens and groups with the concerns by others for being able to afford compliance costs of the rule. USEPA decided on one hand not to raise MCLs across the board as proposed in 1991 in order to maintain existing protections. On the other hand, the agency decided not to lower the radium standard for Ra-228 in response to newer risk information, or to set the lowest possible uranium standard, because of unjustifiable costs of doing so. Scientists have differing opinions regarding data interpretation and uncertainty factors for newly emerging contaminants, much more so than radionuclides with a known mode of action, resulting in large differences in risk assessment factors such as the reference dose. Even with radionuclides, the question of absence or existence of a threshold of effect was the subject of Court action because scientists dispute the meaning of certain data. As Covello and Merkhofer (1994) point out, The current state of the art of risk assessment does not permit questions of science to be clearly separated from questions of policy. In practice, assumptions that have potential policy implications enter into risk assessment at virtually every stage of the process. The ideal of a risk assessment that is free, or nearly free, of policy considerations is beyond the realm of possibility.

Clearly, a reasonable function of government is to protect general public welfare, including protection of public health from known risks. Reducing public health risk, where it can be feasibly done, is wise public policy. At the same time, many choices can only be left up to the individual, recognizing the inevitability of risks in life, and

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government or the private sector may educate people to help them make wise choices to reduce their own risks. Where Congress decides the risk to the citizen is reducible and worth federal intervention it passes a law and directs the executive agencies to write regulations to implement the law. In a time of changing public awareness regarding pollution and radiation, Congress enacted the Safe Drinking Water Act (SDWA) of 1974 (see Chapters 1 and 4). This was followed by amendments in 1986 and 1996. The first interim drinking water rules set by the U.S. Environmental Protection Agency (USEPA) in 1976 included limits on radioactivity. These regulations were revised in 2000 (USEPA 2000b). This chapter discusses key aspects of the development of these radionuclide regulations. USEPA follows the mandates of the SDWA as amended in 1996 to set limits for contaminants in drinking water as close as feasible to a level at which there is known or anticipated adverse effects to the health of persons allowing an adequate margin of safety. In writing new regulations for public drinking water, the Agency has the leeway to establish limits above where they might be set according to the formula of the law in order to maximize health risk reduction benefits at a cost that is justified by the benefits [Sec. 1412(b)(6)]. After the final regulation was published in 2000, four groups ultimately decided to file a petition for review in the US District Court to force a review of the rule. The City of Waukesha WI, along with several interveners were concerned with the radium MCL. The Nuclear Energy Institute’s primary focus was on the man-made beta and photon emitters produced by power plants and the Department of Energy; the National Mining Institute’s interest was largely in uranium, while Radiation Science and Health, an advocacy group, sought review of the zero MCLG for ionizing radiation. The Court heard arguments that USEPA 1) did not conduct a proper benefit-cost analyses pursuant to the SDWA and Administrative Procedure Act, 2) did not use best available science to determine MCLs and MCLGs, and 3) did not adequately respond to comments. The Court ruled in USEPA’s favor on all counts providing clear explanations and interpretations of portions of the SDWA (City of Waukesha v. EPA 2003).

13.2

RADIATION BASICS

A background on radiation terminology and simplified explanation of ionizing radiation is provided in this section for nontechnical readers. Additional detail is available in health physics texts, and the reader is encouraged to further explore this fascinating field. An atom consists of a nucleus of positively charged protons and neutral neutrons surrounded by shells of negative electrons. An atom normally has an equal number of electrons and protons; more of one kind or the other produces an ion. An element is defined by the number of protons, its atomic number. Radium has 88 protons, or it is no longer radium. The atomic mass is the number of protons plus neutrons. An isotope of an element has the fixed number of protons but different number of

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neutrons. For example, radium 228 (228Ra), 226Ra, 224Ra, and 223Ra are isotopes of radium. The combination of 88 protons and 140 neutrons yields radium 228. An isotope of radium (with the same number of protons) yet two less neutrons is radium 226. Collectively, radioactive isotopes of various elements are commonly called ‘‘radionuclides.’’ A radioactive element ‘‘decays’’ in order to reach a more stable energy configuration. The result, if it is a different element, is called a ‘‘progeny’’ or ‘‘daughter.’’ If not stable, it also decays to another daughter, resulting in a decay chain of progeny until a stable configuration (i.e., the element lead) is reached. There are a variety of modes of decay involving different particles including alpha, beta, gamma, as well as positron and gamma waves. Some types of radiation are emitted from the nucleus and others from the electron shells. Alpha particles consist of two neutrons and two protons, the nucleus of a helium atom. When a radionuclide emits an alpha particle it loses two protons and becomes a new element. A negative beta particle is an electron, and results from the decay of a neutron into an electron and a proton. That additional proton results in the progeny being a different element. A positive beta particle is called a positron and can result from the transformation of a proton into a neutron and a positive particle resulting in a new element (with one less proton). Gamma emissions involve a loss of energy, yet do not add or subtract protons to change the atom to a new element, or change the number of neutrons to result in a new isotope. Gamma radiation, known by a broader term ‘‘photon radiation’’ in USEPA rules, is a form of high-energy short-wavelength electromagnetic radiation. Other radiation along the electromagnetic spectrum are X rays, ultraviolet, visible light, and radio waves. A gamma ray is billions of times more energetic than an ordinary photon and can be stopped by thick concrete or lead shielding. It is of concern as external radiation because of its penetrating power. A beta particle can be stopped by clothing or aluminum foil. An alpha particle, which is far more massive (a proton or neutron is about 2000 times more massive than an electron), is stopped by skin or paper. However, once ingested and inside the body, damage is more easily done to unprotected internal organs. When a heavy nuclide such as uranium is bombarded by neutrons, it can split into fission fragments, releasing large amounts of energy and producing new radionuclides. Many synthetic (human-made), elements and isotopes are produced by nuclear power plant reactors, or other controlled reactions. Approximately 3700 plus natural and synthetic isotopes are known to date. Radionuclides decay at a fixed rate specific to each element, and the amount of time for half of the atoms element to decay is termed the half-life. It ranges from fractions of a second to billions of years. Different isotopes of an element can have far different half-lives; it is 1600 years for 226Ra but 3.6 days for 224Ra. Radioactivity is described in terms of the number of transformations occurring in a given time in units called curies or becquerels. It may also be described as a dose of energy imparted to cells in units of rads (radiation absorbed doses) or rems (‘‘roentgen equivalent in man’’ units). The emissions from one gram of radium is called a curie, in honor of the co-discoverers. One curie is 3.7
1010 transforma-

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tions per second. Because this value is so large, a picocurie is typically used, which is one-trillionth of a curie. This translates to 0.037 transformations per second or approximately one emission every 27 seconds. The International System (SI) unit of activity is the Becquerel, which is one emission every second. One Becquerel equals 27 picocuries. The energy imparted to cells by the emissions is called the absorbed dose and is measured in units called the rad (acronym defined above). In SI units, one gray equals 100 rads. The damage caused by radiation may affect chromosomes in the nucleus or organelles in the cell. The high energy particle or wave strips off electrons (ionizes) molecules in its path, so the particles or waves of radiation are called ionizing radiation. Physiologically based biokinetic models are used to describe the distribution and retention of radionuclides in the body, and this information is used to calculate the absorbed dose at different locations in the body. Because of differences in mass and charge, 1 rad of energy deposited by alpha particles creates more damage in a short distance than a beta particle or a single neutron, proton, or photon. The difference in damage is considered in a different unit of dose equivalent called the rem (acronym defined above) or more commonly one-thousandth of a rem, the millirem (mrem). A quality factor of 20 is used to account for the relative differences in harm between an electron or gamma or X rays, and a alpha particle. The dose equivalent in rems of one rad of alpha particles is 20 rems. The SI unit equivalent to the rem is the sievert (Sv), where 1 Sv equals 100 rem. A unit of effective dose equivalent (EDE) uses weighting factors for various organs to allow for the differences in sensitivity to the effects of radiation. Thus, 4 mrem EDE will generally have more tightly grouped range of risks for a suite of radionuclides than 4 mrem (without the weighting factors). However, size matters, and units need to be understood to communicate the protection afforded by a maximum contaminant level (MCL). Any change in units used needs to reflect the same quantity of radiation. Accordingly, care must be taken to change the amount along with the units for equivalency. Sometimes units are preferred because they look more favorable when reported. Certainly the impression given to the public by reporting 1 Becquerel of radiation is better than 27 pCi. Other times conformity with international convention is simply preferred.

13.3

SDWA REQUIREMENTS FOR RADIONUCLIDE STANDARDS

The 1974 SDWA provided for a health-based recommended maximum contaminant level (RMCL), and an enforceable standard, the MCL. The amendments of 1986 stipulated that USEPA simultaneously establish the two numbers when writing a National Primary Drinking Water Regulation (NPDWR). The RMCL was changed to a maximum contaminant level goal (MCLG), a health-based numerical target number, and is the level at which no known or anticipated adverse effect on the health of persons occur and that allows an adequate margin of safety. The other is the enforceable standard, the MCL. The MCL is to be set as close as feasible to the

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MCLG using the best available treatment (BAT) technology in field (not laboratory) use, taking costs into consideration. 13.3.1

Linear No-Threshold Assumption

Ionizing radiation causes cancer, an established fact observed in humans at high radiation doses (the Japanese bomb survivors, radium dial painters, worker exposure to radioactivity) and in animal experimentation. Ionizing radiation, in stripping electrons from molecules in vital places (in DNA), can initiate or promote a cancer, although a small amount of radiation produces a statistically tiny probability of that happening. However, the greater the number of particles emitted the greater the risk that one particle will cause a serious malfunction leading to uncontrolled cell growth. USEPA has adopted by policy an MCLG of zero for most carcinogens. This policy that all exposure to carcinogens be prevented where possible because any exposure can conceivably result in malignancy, has its origins in the Eisenhower administration. Detection of carcinogens at lower and lower concentrations is now possible, representing smaller and smaller risks. The Agency generally sets MCLs so that the resulting cancer risk falls within a band of 1
104 to 1
106 (1 in 10,000 to 1 in 1,000,000). USEPA utilizes the linear nonthreshold (LNT) hypothesis, which presumes that a single insult to a cell is enough to initiate cancer (that there is not starting point or threshold of effect) since experimentally, a single alpha particle traversing a cell nucleus is sufficient to induce a mutation caused by un- or misrepaired DNA lesions and chromosomal damage. It presumes that a straight-line relationship exists between radiation dose and cancer risk. This straight line links the damage from a single ionizing event to the observed cancers in larger doses. Whether the relationship between the radiation and the effect is linear or quadratic or something else, the severity of the resulting effect (cancer) is not related to the number of particles that cause the cancer, which would be a ‘‘deterministic’’ effect (at high doses, the severity of acute radiation sickness is related to dose), but the probability of cancer is proportional to the number of particles being fired at the cells by the radioactive element, a ‘‘stochastic’’ effect. A degree of scientific controversy exists regarding the existence of a threshold of effect at the low environmental levels of radiation. Is there a point for some or all radionuclides or some types of cells where cells are not affected, or are able to adaptively respond at low levels to the insult to protect the cell at higher levels? Is there a stimulating or beneficial ‘‘hormetic’’ effect of radiation? Or is the cellular response in defense a sure sign of the adverse nature of the threat? This is a continuing area of research and debate, but without convincing proof to the contrary, the LNT model is utilized for regulatory purposes. 13.3.2

Non-cancer Effects

The MCL for uranium is based on chemical toxicity, not cancer, although cancer is also a concern. For noncancer effects, the MCLG is determined by several factors. The reference dose is calculated by dividing the lowest, or no-observed-adverse-

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effect level (LOAEL or NOAEL) by appropriate safety factors (from 3- to 10-fold to account for inter- and intraspecies variability, short versus chronic study, LOAEL versus NOAEL to arrive at a reference dose (RfD) in units of milligrams per kilogram per day (mg kg1 day1). Multiplying by 70 kg adult weight and dividing by 2 L=day consumption yields the drinking water equivalent level (DWEL) number in milligrams per liter (mg=L). This number is multiplied by the relative source contribution (RSC), to determine the MCLG. The RSC is the proportion of the total contaminant consumed via drinking water versus food, dermal absorption, or inhalation. The higher the RSC, the correspondingly higher the MCLG for non-carcinogens. But, simply taking drinking water as a percentage of food plus other exposures may show it to be a high percent or a low percent with no relationship to the total reference dose allowed before effects are seen. For example, if water is only 20% of the total exposure from all sources, multiplying the RfD (converted to the DWEL) by 20% would yield a small MCLG. Yet if that total from all exposures is only 50% of the RfD, the MCLG might be set artificially low because it leaves much of the reference dose ‘‘unused’’. Even though water was 20% of the total exposure, the total was only half of the RfD allowance. Alternatively, an arguably better method is to subtract the actual amounts from food or other exposures leaving the rest of the RfD as the limit for water. The MCLG may be more correctly set higher, because after exposures from food etc. are subtracted from the RfD, there is still much leeway to what is an effect level. It leaves that portion of the RfD (or less for an additional safety factor), to become the MCLG. In the above case if the DWEL were 100, the first MCLG (by percentage) would be 20, and the second (by subtraction) could be 60 (80% of the 50% is food, etc. ¼ 40, leaving 60 for water). Additional safety factors to account for error may be applied to lower that level. Better data can change any one of these factors and may result in a change to the calculated MCLG when USEPA reviews regulations and revises them as required every 6 years. For carcinogens with no proven threshold of effect, the MCLG remains at zero because the adverse cellular effect is seen in concentrations above zero.

13.4

1976 RADIONUCLIDE REGULATIONS

There are several possible approaches for setting radionuclide limits: limiting either the concentration, the dose, or the risk, and doing so either for individual nuclides or for a group of nuclides. Considering the relationships between concentration, dose, and risk may be helpful. The concentration in picocuries of emissions in water result in a dose of energy imparted to the body, which then results in a certain risk of disease or death. A different concentration of each nuclide is needed to produce a given dose, and that dose results in different risks depending on the organs affected. Thus, whichever expression, concentration, dose or risk is selected to be the MCL the other two will vary considerably. Set the limit as concentration, and the dose and the risk vary widely. Set the dose as a limit, and risk and concentrations vary. Set risk as a constant, and concentrations and dose differ.

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USEPA usually sets limits for individual contaminants. But, having several contaminants present at their limits increases the total risk in the drinking water. Therefore, limiting a group of contaminants in aggregate allows individual latitude as long as the mixture does not exceed the standard. In 1976, USEPA regulated radium, alpha-particle emitters, and beta-particle and photon emitters under the 1974 SDWA. USEPA expected new data, and to change the rule within a short timeframe as new models became available and termed the rule national interim primary drinking water regulations. The 1976 rule set an MCL of 5 pCi=L as combined standard for 226Ra þ 228Ra. This limit provided protection for the most people at a reasonable cost given the data at the time. The risk was believed to be between 5
105 (1 excess death in 20,000) and 2
104 (1 in 5000). Alpha emitters were set at a total limit of 15 pCi=L and termed gross alpha. ‘‘Gross,’’ however, did not include either uranium, or radon, both alpha emitters, because they would be included in future rules. The uranium limit was finally established 24 years later, in the 2000 rule, but regulation of radon is still pending. There is no single risk number associated with the 15-pCi=L limit for alpha emitters because the concentration limit applies regardless of the nuclide. Because each nuclide emits alpha radiation of different energies and may accumulate in different organs of varying sensitivity to radiation, 15 pCi=L yields greatly different risks depending on the nuclide in question. The beta particle and photon emitters’ MCL was established as a dose to the whole body or to the critical (most affected) organ, accompanied by a table of the picocurie concentration limits for each nuclide at 4 mrem. The nuclides and limits were calculated on the basis of a 2-L=day drinking water intake using the 168-hour data listed in Maximum Permissible Body Burdens and Maximum Permissible Concentrations of Radionuclides in Air or Water for Occupational Exposure (NBS Handbook 69), which was incorporated by reference into the rule. The 1976 rule attempted to limit maximum risk to a reasonably conservative level: one excess death per million people per year from synthetic radiation in drinking water. One a year translates to 70 times that in 70 years, and thus, 7
105 risk. USEPA selected a dose limit of 4 mrem as being closest to the risk limit for whole-body dosers, although other nuclides would represent a much smaller risk at that same dose. (The origin of 4 mrem is less certain, reportedly a compromise between a log number of 3 mrem and an average of 5 mrem.) Regardless, in performing an analysis of risk of the selected 4 mrem, the geometric mean of the relative and absolute models was 0.8 deaths per million persons per year rather than one death. Therefore the lifetime risk (0.8
70 years) was 5.6
105. This was meant to be a ceiling or maximum risk represented by a whole-body doser, not a target. It was not intended to be a goal like an MCLG to which all of the nuclides should be as close to as possible. Rather, it was to be a ceiling, the highest risk, represented by the whole-body dosers. (Later, in 2000, an MCLG of zero would be published for ionizing radiation.) In setting a dose limit USEPA understood that risks would vary widely. The greatest risk could be estimated at 4 mrem, but having both a constant risk and a constant dose was not possible. The Court ruling explained that USEPA is not required to set or revise numbers to achieve a constant risk (City of Waukesha v. EPA 2003).

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This approach of setting a dose limit makes each nuclide equal to the overarching limit of dose or risk that serves as the MCL for the group. For example, the beta particle and photon emitters have a limit equal to the dose of 4 mrem. There is of necessity a table of individual concentration values for each radionuclide equal to that 4 mrem dose for monitoring purposes. Concentration has to be specified because water systems monitor the concentration, not the dose or risk. Any combination of nuclides would be allowed as long as all together (aggregately) they did not exceed the assigned dose limit, in this case 4 mrem. This is the ‘‘sum of the fractions’’ approach and could work for a limit based on risk as well. Each nuclide’s individual concentration limit is set equal to the whole dose or risk selected as the MCL. The quantity of a nuclide actually present would be divided by its picocurie allowance resulting in a fraction of what is allowed. If 14 pCi of nuclide Q equals the MCL of, say, 4 mrem, and 14 pCi is present, the limit of 5 mrem is reached. If any other nuclide is present, it will cause the limit to be exceeded. However, if two nuclides are present at half their respective picocurie allowances, that also means that each is at half of the 4 mrem allowance as well. Both halves added bring the water to the limit. If there are multiple nuclides, the sum of all the fractions of individual 1 þ 14 ¼ 43 Þ: Since this exceeds one concentration limits present (e.g. 16 þ 23 þ 12 (unity) the MCL is exceeded. Compliance with the MCL would mean that one or more of the constituents could be treated until the sum of the fractions is one or less. A third approach is to limit total risk from any combination of nuclides. Risk as the MCL approach would not have been feasible in 1976 because of the inability to specify a risk for a given concentration for each nuclide. By 2000, USEPA could calculate risks at a given concentration using the Federal Guidance Report 13, published in September 1999 (USEPA 1999). A caveat is in order with respect to risk. If a risk limit were set for a group or an individual nuclide in drinking water such as 226Ra, the concentrations equal to the given risk would change as risk models changed. The limiting concentrations would rise or fall based on model results. This could pose great difficulties for public water systems by putting them in or out of compliance with the MCL especially if risk were done on an individual basis. A total group risk ceiling allows variations to constituents as long as the total risk cap was not exceeded, but a calculation of risk via modeling carries its own risks! USEPA could have set a limit on the total concentration of beta=photon emitters just as it did for alpha emitters. The risk would then vary considerably depending on the individual nuclides present. Alternatively, each nuclide could also have separate concentration limits as individual MCLs where the total dose, and the total risk, would be driven by the combination of nuclides actually present in the water. However, when USEPA developed limits for beta and photon emitters in 1976, dose was selected as the limit for a very practical reason: to retain the ability to revise concentration numbers as dose conversion methodologies matured, without having to change the overall MCL. USEPA expected the numbers to change in a few years, and published the rule as interim. However, 10 years later, the numbers had not been changed in any way, and the SDWA in 1986 declared that all interim rules were final national primary drinking water regulations (NPDWRs). Regulation writers reasoned in 1976 that if the concentration was changed periodically, but still limited

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to a 4-mrem dose, only a new handbook need be published correcting the table, rather than a rulemaking, with its attendant proposal, public comment and final rulemaking. With an MCL as dose, an underlying number could change while leaving the MCL itself, the 4-mrem dose, alone. What seemed like a good idea in 1976, in later years, did not seem as wise. In the late 1990s, the USEPA drinking water program decided against an effort to change the beta and photon emitters to higher limits and to allow future concentrations to float by tracking on periodic guidance documents. USEPA believed that changing the numbers to which water systems would be accountable rightly deserved a period of public comment. Even if the MCL did not change, if the concentrations of individual constituents tied to that dose limit change, it affects treatment at water systems and at sites where remedial actions use the limit for that constituent as a cleanup target. Furthermore, changing concentration, changes the risk, and the 1986 Amendments specified that MCLs be revised whenever treatment technology would permit greater protection to the health of persons.

13.5

1991 PROPOSED RADIONUCLIDES RULE

In 1986, USEPA had published a list of 83 possible contaminants for future regulation for public comment in an Advanced Notice of Proposed Rulemaking (ANPRM). However, later that year, the SDWA reauthorization passed, and Congress responded by requiring USEPA to regulate all 83 contaminants, including uranium and radon. The 1986 SDWA prescribed a review of the rules every 3 years. In addition, MCLGs for radionuclides were needed. In 1991, USEPA published a proposal increasing both radium 226 and 228 from 5 pCi=L together, to 20 pCi=L each (USEPA 1991). In addition, 226Ra would have been removed from the count of the gross alpha limit of 15. The new limit, termed adjusted gross alpha, would allow greater amounts of other contaminants to take 226 Ra’s vacated place within the limit. The 1991 proposal included a limit of 20 mg=L (according to the rule, equivalent to 30 pCi=L) for uranium. It also changed the MCL for beta and photon emitters from 4 mrem to 4 mrem EDE. The latter change appeared as though the MCL had remained the same, but used newer units. However, the change in units changed the associated concentration limits dramatically. On average for the synthetic (human-made) nuclides, 4 mrem is actually equivalent to about 0.9 mrem EDE for the aggregate of nuclides. Regardless of the dose units, the actual radiation needed to remain the same for the effect on the body to remain the same. To illustrate, in units of Fahrenheit, 72 F is comfortable. But in switching to a new brand of thermostat using Celsius units, the temperature should not be set again to 72 C but to 22 C. At 72 C the room would be decidedly hotter, the equivalent of about 162 F. Likewise changing from 4 mrem to 4 mrem EDE made the allowance of the radionuclides’ concentration in picocuries ‘‘hotter.’’ At a minimum, the change in units should have been accompanied by a change in the MCL number from 4 mrem to 0.9 mrem EDE. However, because the rule covered many individual nuclides and not an average, it still would have resulted in many nuclides being at higher picocurie concentrations than they had been before.

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REGULATING RADIONUCLIDES IN DRINKING WATER

The 1991 proposed limit for radon was controversial, and a series of Congressional actions delayed final action on the 1991 radionuclides proposal. Furthermore, the regulatory approach was novel if not unorthodox. The Agency attempted to apply an overall risk bubble concept of costs and benefits for radium and radon to avoid disproportionate costs of controlling radium versus radon. Radon is less expensive to treat because it is volatile. A greater risk reduction ‘‘bang for the buck’’ could be obtained by treating radon than radium. Therefore, the risks and rewards of both contaminants were considered together in the proposal. Radium was separated into two different MCLs: the beta-emitting 228Ra and the alpha-emitting 226 Ra each at 20 pCi=L. By adding in the benefit of regulating radon, these contaminants could be given higher limits, which were thought to be less risky than before. However, a rule to allow more radium, while removing some radon, might have a positive overall impact in the northeast radon corridor, but would have negative consequences in the upper Midwest, where radium is prevalent. Nationally the risks may have been lower overall, but regionally they were not. The concept of protecting the ‘‘health of persons’’ in SDWA is rooted in consideration of individual not collective risks. In essence, the 1991 proposal suggested relaxing the standards on all fronts. Unfortunately, this had long-term negative consequences for the water systems in compliance with the 1976 rule, and for those systems not in compliance. Some water systems were hesitant to install expensive treatment or even to explore alternative water sources if USEPA intended to declare their water to be safe by increasing the MCL. USEPA had given the states’ ample discretion in enforcement, but this was a tough policy call. On one hand, the 1986 Amendments declared interim rules to be final rules. Some systems would fall back on the ‘‘interim’’ status even in the year 2000, as an excuse for noncompliance since 1976. At least one city would be sued by citizens and lose. On the other hand, a proposal to increase limits gave plausible pause to both systems and enforcers. On one hand, the 1976 rule was still the law and enforceable until changed. The 1991 proposal did not legally count in decisionmaking. On the other hand, it did telegraph the Agency’s direction of thought. Unfortunately, 9 years ensued to a final rule, perpetuating the dilemma to those systems out of compliance, and causing a hardening of the attitudes for those with varying points of view. Fortunately, the 2000 final rule is more scientifically defensible than the 1991 proposal. In particular, the 2000 final rule was crafted with the spirit and letter of the law on an important point: it ensures that protection obtained is protection maintained. Significantly for this rule and future rules, a later court ruling discussed below affirmed that revisions to MCLs should not backslide in protection.

13.6

1996 SDWA AMENDMENTS AND RULE REVISIONS

A change in an MCL has an effect on public health and the operation of the water treatment systems. In the 1974 SDWA, Section 1412(b)(4) stated that ‘‘revised national primary drinking water regulations shall be amended whenever changes

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in technology, treatment techniques, and other means permit greater protection of the health of persons, but in any event such regulations shall be reviewed at least once every 3 years’’. Again in 1986 the SDWA amendments addressed this issue in Section 1412 (b)(9) with very similar yet even stronger language. In the 1996 Amendments, what became known as ‘‘antibacksliding’’ was debated in Congress and the intent of the 1986 Amendments was retained in slightly different language. Revision to the 1976 rule was subject to the following provision [Sec. 1412(b)(9)]: The Administrator shall, not less often than every 6 years, review and revise, as appropriate, each national primary drinking water regulation promulgated under this title. Any revision of a national primary drinking water regulation shall be promulgated in accordance with this section, except that each revision shall maintain, or provide for greater, protection of the health of persons.

A critical factor in writing a defensible rule is ensuring that it complies with the mandates of the enabling legislation. A reasonable person reading the plain sense of the law can understand the intent of Congress. The House of Representatives and Senate legislative histories illuminate possible uncertainties. The reasonable reading, the simple, plain meaning is the first choice. Very rational sounding, but wrongheaded arguments can be put forward by overcomplicating the terms and introducing concepts that are not present in the legislation. For example, the word ‘‘protection’’ became a source of some misunderstanding arising from using ‘‘risk’’ and ‘‘protection’’ interchangeably. That issue arose in terms of the radium and alpha standards, and in a different form for the beta and photon emitters. ‘‘Maintaining protection’’ is not synonymous with ‘‘maintaining risk’’ because risk is calculated on the basis of changing models. Protection relates to deterrence or shielding from harmful agents, in this case, ionizing radiation. Therefore, the numerical limit, the drinking water MCL, guards against excess consumption of radionuclide-contaminated water. Risk is the exposure to the chance of harm. It is expressed as an estimation of danger or harm arising from the lack of protection from a harmful contaminant. The concentration that still remains in the water at or below the MCL is what causes the risk. Increasing the numerical limit causes an automatic increase in risk, given an upward dose–response relationship. It means more of a bad thing . . . is a worse thing. But, can an MCL ever increase above its current level if feasibility is questioned, or if the MCLG increases, or if its risk has declined? With respect to changing the limit based on feasibility=cost considerations the SDWA exempts pre-1986 MCLs from its cost benefit requirements and USEPA left the MCLs unchanged. The Senate report (Congress 1995) on the SDWA amendments of 1996 explains that [S. Rept. (Senate Report) 104-169] It is quite possible that a future Administrator will be required to issue or reconfirm an existing standard with costs that the Administrator does not believe are justified by the benefits. Because the valuation placed on the benefits achieved by a regulation is

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necessarily shaped by the subjective judgment of the Administrator, it is to be expected that some future occupant of the position may find a standard issued by a predecessor too costly for the benefits obtained. Nevertheless, section 1412(b)(9) would require that the standard be reissued or retained.

An MCL is set as close to its MCLG as feasible. With an existing rule, because systems are meeting the MCL, its feasibility is demonstrated and the standard cannot be weakened in the future by a determination that attainment of the standard is not feasible for systems today. The issue of MCL relaxation is tied to changes in the MCLG. The Senate report (Congress 1995) added a footnote that an ‘‘existing standard may be relaxed, but not on the grounds of a cost-benefit analysis. If new science shows that a less stringent standard would provide the same level of health protection, the MCL may be revised upward’’ (S. Rept. 104-169). Earlier, the Senate report explained the circumstance in which an MCL may be relaxed: if new scientific information causes the MCLG to be revised to a higher number than the MCL, the MCL would change upward because it need not be more stringent than the MCLG and overshoot the goal. The MCLG is set at a level of no known or anticipated adverse effect on the health of persons with an adequate margin of safety. Calculations of it therefore contain safety factors. These may change as better data on health effects decrease the uncertainty, accounting for extrapolations from animal to human, between humans, for a short- versus a longterm study, for a lowest observable adverse effect level (LOAEL) instead of a no observable adverse effect level (NOAEL), or if the relative source contribution changes. With better data from a better study, the uncertainty becomes smaller, and the calculated MCLG can rise. For example, if an uncertainty factor were to change from 1000 to 100, the calculated no-effect level, the MCLG, would rise by a factor of 10, say, from 5 to 50 parts per billion (ppb). If the MCL had been at the MCLG, it would also rise to 50, ‘‘since it need be no more stringent than the MCLG.’’ The same is true for carcinogens. If one is reclassified or assigned a threshold, the MCL need only be at that threshold of no effect. However, both numbers do not necessarily rise. If the MCL has been set at 20 and the MCLG rises from 0 to 10, the MCL remains the same (or can drop if feasible). The aim is to get as close to the MCLG as possible and the MCL of 20 is now numerically closer to the new goal (MCLG) of 10 than it had been to the old goal of 0. Only if the MCLG were to overtake the MCL (rise above 20) would the latter also rise. Can an MCL be revised to maintain risk? In the case of radionuclide regulations the estimate of risk is constantly changing as new information from more sophisticated modeling methods becomes available. If the models change, presumably for the better, can MCLs be adjusted regularly to match the risk we envisioned as being protective? In other words, what if the risk of a radionuclide is less than originally thought? Could its concentration then be increased to the originally anticipated risk while still maintaining our same protection? The answer to the question is ‘‘No,’’ for two reasons: 1) The focus is wrong—are we getting closer to the goal, the MCLG, or

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not? The MCLG is the target and while the MCL selected represents some risk, the risk number is not the target. 2) As discussed below, any increase in concentration also increases risk relative to what it used to be. An illustration demonstrates the fallacy of equating ‘‘maintaining risk’’ with ‘‘maintaining protection.’’  Assume a risk of 1 in 10,000 of getting cancer was considered to be 7 pCi=L for a nuclide.  A new model now shows the 1 in 10,000 risk to actually be 14 pCi=L instead.  If the MCL was 7 pCi=L, raising it to 14 pCi=L would not ‘‘maintain’’ the risk of 1 in 10,000. Instead using the same new model to calculate the risk of 10 pCi=L will reveal 7 to be actually 1 in 20,000 risk.  Increasing the MCL from 7 to 14 actually increases the real risk in the water 2 fold (from odds of 1 chance in 20,000 up to one in 10,000) and thereby simultaneously decrease protection 2 fold.  Protection is maintained by retaining the MCL of 7, regardless of the risk it was perceived to be. The radionuclide did its damage irrespective of the correct or incorrect risk assigned to it. Maintaining the concentration maintains the protection by maintaining the associated actual risk at any concentration. A greater concentration will be a greater risk. Only by using the two different models, one old and one new, can the same risk be assigned to two different concentrations, leading to the false conclusion that risk was maintained. Only with an odd U-shaped dose–response curve could 7 and 14 have the same risk. Or, if a threshold is discovered at 30, both 7 and 14 are the same, no risk—although it could be argued that 10 is still more protective, allowing a greater cushion before an effect would be felt. Otherwise with a linear model of risk, a lower number is always a lower risk than a higher number regardless of the numerical risk assigned. An MCL’s actual risk at the numerical limit may be simply lower than was thought, thus making the protection greater than imagined. Maintaining risk by changing to 14 is an illusion, because the erroneous calculated level of risk is used, and protection is not provided to the same actual level of risk. Protection cannot be maintained while increasing the concentration of the substance regulated. Protection is inversely related to the amount of exposure to the harmful agent from which protection is desired. From another perspective, even if the calculation (modeling) of risk changes, the radioactive element itself does not. If today’s model shows that 7 pCi=L of an element is half the risk thought years ago, could someone drink twice as much radiation, 14 pCi=L, and have the same protection from radiation? The question is whether the effect on one’s body is still the same at 14 as it is at 7. In the absence of a threshold of effect, it certainly is not. Therefore, all things being equal, a higher concentration (picocuries, or mrem, or risk) is less protection. Only the misperception of equal risk would be maintained, but the actual risk to the public would rise.

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REGULATING RADIONUCLIDES IN DRINKING WATER

In Waukesha et al. v. EPA (2003), the Court stated: Because the SDWA defines ‘‘maximum contaminant level as ‘the maximum permissible level of a contaminant in water which is delivered to any user of a public water system, (emphasis added), EPA is right to focus on the level of contaminant set by the original MCL rather than the degree of protection that such a level was anticipated to provide . . . Petitioners contend that this provision does not prohibit EPA from revising an MCL upward when (as here) scientific advances show that a contaminant poses less risk than previously believed . . . This argument requires inferring the following bracketed and italicized qualification to the actual language of x[1412](b)(9): ‘[E]ach revision shall maintain, or provide for greater, protection of the health of persons [than the agency initially thought it was providing].’ But there is nothing unreasonable about EPA’s decision to decline to read such a qualification into the section and instead to regard it as a straightforward instruction to maintain the level of protection that the initial MCL actually provides.

Some ask if a revised risk estimate puts the risk of a contaminant below the low end of the Agency’s risk range of 106, should the MCL be increased to that policy de minimus threshold? Again the Senate Report (Congress 1995) speaks to the issue: This amendment to the law does not provide the Administrator with authority to set MCLGs based on a finding that the cancer risk is negligible or so small as to be acceptable; the Administrator is not authorized to use the authority to set a ‘‘policy’’ threshold below which increased cancer risks are not considered in standard setting.

As a practical matter, if USEPA regulated simply based on risk estimates, the MCL would rise and fall with the fortunes of each risk model. For example, the original calculation for radium 226=228 was a risk between 5
105 and 2
104 for a combination of 226Ra and 228Ra at 5 pCi=L. In later years, estimates could be made separately, and by the 1991 proposed rule, 1
104 was thought to be 22 pCi=L for 226 Ra and 26 pCi=L for 228Ra using the RADRISK model. Today’s model shows Ra226 at 22 pCi=L to be 10 fold higher at 1
103 and Ra-228 at 26 pCi=L to be 3.3 times higher risk (USEPA 2000a). The proposed MCLs selected in the 1991 proposal were 20 pCi=L each. The 1991 standard would have allowed up to 40 pCi=L total radium or about 4–20 times higher than high=low combinations of radium (e.g., 5 pCi=L of 228Ra and 0 pCi=L of 226Ra in the 1976 combined standard). Had those limits been selected as MCLs in 1991, a new rule would again have to be promulgated to bring them back in line with the new model’s calculations, resulting in a moving target and extreme uncertainty for the drinking water industry and for the public.

13.7

2000 FINAL RADIONUCLIDES RULE

Briefly, the final 2000 rule (USEPA 2000b) maintained protection from radionuclides, but made certain changes to monitoring requirements. MCLs are summarized

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in Table 13.1. Monitoring frequencies for gross alpha, uranium, and radium 226=228 are summarized in Table 13.2. Figure 13.1 illustrates the basic components of isotopes. Entry points to the distribution systems are now monitored to ensure that some consumers were not on ‘‘hot’’ wells while others were on ‘‘cool’’ wells, as when monitoring was done at a representative blended point. Hence, greater protection should result. Monitoring for beta and photon emitters is only conducted by vulnerable systems. BAT and small system compliance technologies for radionuclides are summarized in Tables 13.3 and 13.4, respectively. Compliance deadlines are listed in Table 13.5. USEPA has developed several helpful guides to assist states and water utilities in complying with this rule (USEPA 2001, 2002a, 2002b). Nontransient, noncommunity systems (those serving less than 15 service connections for more than 6 months out of a year, e.g., schools, nursing homes, hospitals, churches, campgrounds, prisons) are not regulated because of doubts regarding the exposure that the typical consumption would represent, although these systems may be included in the rule in the future as they are for other drinking water rules. Approximately 60% of risk is given in the first 18 years of a lifetime of exposure to radium. Because schools can represent an important point of exposure to children, any doubts regarding regulation should be decided in favor of children’s health. 13.7.1

Alpha Emitters

In the 2000 rule, the gross alpha count continued to include 226Ra, an alpha emitter, and exclude uranium and radon as in the original 1976 rule. It is more helpful to think of the MCL as ‘‘net alpha’’ (the total alpha from the gross alpha analytical method, minus radon and uranium for a net result). The proposal in 1991 removed 226 Ra from the count of alpha emitters because it was proposed to be regulated separately, terming the level ‘‘adjusted gross alpha.’’ However, removing it would allow other alpha emitters to be present at higher levels replacing the 226Ra, which was no longer counted toward the 15 pCi=L limit. The new standard would therefore not maintain protection. The term ‘‘gross alpha’’ is better used for an analytical method, and the term ‘‘net alpha’’ is better used to refer to the MCL, because it excludes Rn and U. However, because the term has been in use for so long, USEPA retained the old terminology. 13.7.2

Radium 226=228

As discussed earlier, USEPA was following whenever the models led in the 1991 proposal. It led in a proverbial circle from a perceived risk of about 1
104 at 5 pCi=L in 1976 to above 20 in 1991 to 10 in 1994 and back to 5 in 2000. In the case of 228Ra, the calculated risk using the Federal Guidance Report 13 (USEPA 1999) is now greater per picocurie than previously thought, resulting in a 2
104 risk at 5 pCi=L, the upper risk range estimate in 1976. However, to maintain the same protection from radiation, the numerical limit could remain the same. After all, the results in the body of the same amount of radiation did not change even though our perception of its risk did. USEPA considered the feasibility of lowering

324

b

Source Naturally occurring Naturally occurring Naturally occurring Contamination

MCL 15 pCi=L (no radionuclide þ uranium) 5 pCi=L 30 mg=L 4 mremb=year

A total of 179 individual beta particle and photon emitters may be used to calculate compliance with the MCL. Milliroentgen equivalents per man.

Zero Zero Zero

Radium 226 þ 228 Uranium Beta particle and photon emittersa

a

Zero

MCLG

Radionuclide

Gross alpha emitters

Radionuclide MCLs

TABLE 13.1

Cancer risk Kidney toxicity; cancer risk Cancer risk

Cancer risk

Health Effect

13.7 2000 FINAL RADIONUCLIDES RULE

TABLE 13.2 226=228.

325

Monitoring Frequencies for Gross Alpha, Uranium, and Radium

Initial 40 CFR 141.26(a)(2)

Four consecutive quarters of monitoring at each entry pointa

Reduced 40 CFR 141.26(a)(3) Gross Alpha and Uranium One sample every

Systems may composite up to four consecutive quarterly samples from a single entry point if analysis is done within a year of the first sample

Nine years if average of the initial monitoring for each contaminant is below the detection limit listed in 40 CFR 141.25(c) Six years if average of the initial monitoring results for each contaminant is at or above the detection limit but at or below 1 2 MCL Three years if average of the initial monitoring results for each contaminant is above 1 2 MCL but at or below the MCL If the results from the composited sample are less than 12 MCL, reduce in accordance with the given schedule above

Combined Radium 226=228 Four consecutive quarters of One sample every monitoring at each entry point

Nine years if average of the initial monitoring for combined radium 226=228 is below the detection limit listed in 40 CFR 141.25(c) Six years if average of the combined initial monitoring results for combined radium 226=228 is at or above the detection limit but at or below 12 MCL Three years if average of the initial monitoring results for combined radium 226=228 is above 12 MCL but at or below the MCL (continued )

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TABLE 13.2

(Continued )

Systems may composite up to four consecutive quarterly samples from a single entry point if analysis is done within a year of the first sample

If the results from the composited sample are less than 12 MCL, reduce in accordance with the schedule given above

Systems may substitute the gross alpha results that are 15 pCi=L for uranium to determine compliance and the reduced monitoring frequency. Systems with gross alpha result greater than 15 pCi=L must collect uranium sample(s) to determine compliance and reduced monitoring, per 40 CFR 141.26.(a)(5).

a

the absolute limit of 228Ra to 3 pCi=L (within a combined limit of 5) to reduce the overall risks of 228Ra individually or as a combination of 226Ra and 228Ra. After examining the costs and benefits of a lower limit of 3 pCi=L for 228Ra, the Agency concluded that the incremental risk reduction benefits was not justified by the costs. Radium is treatable to a lower level, closer to the MCLG, but the high cost is not worth the fraction of a life saved as a result.

Figure 13.1 Isotope nomenclature, illustrating two ways to describe radioisotopes.

TABLE 13.3 BAT for Radionuclides Contaminant Gross alpha emitters (less Rn and U) Radium 226 þ 228 Uranium Beta particles=photon emitters

BAT Reverse osmosis Ion exchange, reverse osmosis, lime softening Ion exchange, reverse osmosis, lime softening, coagulation=filtration Ion exchange, reverse osmosis

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TABLE 13.4

Small System Compliance Technologies for Radionuclides Compliance Technologies Appropriate for System Sizea

Technologies Ion exchange (IE) Point of use (POU) IE Reverse osmosis (RO) POU RO Lime softening Green sand filtration Coprecipitation with barium sulfate Electrodialysis=electrodialysis reversal Preformed hydrous manganese oxide filtration Activated alumina Enhanced coagulation=filtration

25–500

501–3300

3301–10,000

C,a B,b Uc C, B, U C, G,d B C, G, B, U C C C

C, B, U C, B, U C, G, B, U C, G, B, U C, U C C

C, B, U C, B, U C, G, B, U C, G, B, U C, U C C

C

C

C

C

C

C

U U

U U

U U

a

Combined radium 226=228. Beta particle activity and photon activity. c Uranium. d Gross alpha-particle activity. b

Previously, the gross alpha method was used to screen for alpha emitters and the result was to be presumptive for 228Ra, a beta emitter in the following manner. Alpha emitters were limited to 15 pCi=L. If the test result was at or below 15 pCi=L, the MCL was met for gross alpha. If results were above 5 but below 15, the result could represent what the 226Ra concentration in the water was, and 226Ra would have to

TABLE 13.5 Radionuclide Rule Compliance Deadlines Date

Requirement

June 2000

Dec. Dec. Dec. Dec.

8, 8, 8, 8,

2000 2002 2003 2003

Dec. 8, 2004 Dec. 31, 2007

Data collected between June 2000 and Dec. 8, 2003 may be eligible for use as grandfathered data (at state discretion) to satisfy the initial monitoring requirements for gross alpha, radium 226=228, and uranium Final radionuclides rule published in Federal Register State primacy revision application package due Effective date of the rule Systems must begin initial monitoring under their state-specified monitoring plan unless the State permits grandfathering of data collected between June 2000 and Dec. 8, 2003 State primacy revision application package due for those states requesting a 2-year extension All water systems must have completed initial monitoring

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be measured. If results of gross alpha measurement were below 5 pCi=L, including the high-side measurement error at 1.65 sigma (standard deviation), 95% confidence, the result could be taken as the proxy amount of 226Ra. If the result were below 3, the 228Ra need not be measured even though it is a beta-particle emitter. The reason was a presumption that there was a relationship in occurrence between the two. If 226Ra were not above 3 pCi=L, then 228Ra would be unlikely to occur above 2 pCi=L, and the sum of the two would not exceed 5 pCi=L. However, even though they are both radium by virtue of their 88 protons, the two are independent of one another; 228Ra (a beta-particle emitter) is derived from the thorium decay chain and the 226Ra (an alpha-particle emitter), from the uranium decay chain. Minerals containing U and Th co-occur, but the thorium is relatively insoluble, and it, or its daughters, may not be found in the groundwater. A reconnaissance study by USEPA=USGS=AWWA of 100 wells showed a weaker co-occurrence relationship between the two isotopes of radium than between 228Ra and 224Ra, which are in the same decay chain (Focazio et al. 1998). Because 226Ra cannot be used as a predictor of 228Ra, the new rule requires the testing of 228Ra. The result is added to either the proxy alpha result for 226Ra or actual 226Ra result for comparison to the MCL. Instead of lowering the standard for 228 Ra, USEPA was able to maintain the stringency of the standard with the same allowance of radiation, yet increase overall public health protection by decreasing the amount of 228Ra in approximately 270–320 water supplies around the country affecting 380,000–460,000 people, via the change in the monitoring requirement, which will result in finding and treating the contaminant. At least one state knew the existence of 228Ra in their water, which, when added to the amount of 226Ra present, would exceed the standard, but the old rule did not require monitoring for 228Ra separately from 226Ra results. The SDWA does not hold a system in violation of the standard even if it is exceeded, if the monitoring to discover the contaminant was not required in the first place. Uncertainty over the future standard resulted in a holding pattern for radium fixes in some states even where monitoring was required. In this case, it resulted in a policy of emphasis on the letter rather than the spirit of the law to ignore the excess radium because there was no requirement to look for it. Thus, monitoring directly for the existence of 228 Ra, a beta emitter from a different decay chain was common sense and good science, and fixing this loophole a sensible thing to do while still retaining the MCL. 13.7.3

Radium 224

Tests of gross alpha done within approximately 48–72 hours may reveal alpha activity due to 224Ra or its daughters. Radium 224 is a short-lived (3.66-day halflife) great granddaughter of 228Ra on the thorium decay chain. Within a little over a month (10 half-lives), the 224Ra as well as its very short half-life progeny has decayed. The 1976 rule had not focused on this radium as a problem in drinking water, although testing for gross alpha would include it, and it could be present in drinking water with a short residence time in the distribution system. Radium 224 surfaced as an issue when New Jersey did some sleuthing for an environmental cause

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for some mysterious brain tumors in children in South Jersey. Comparison of gross alpha results from four composited quarterly samples taken during the year as allowed by rule, and quick turnaround samples, showed a large disparity. The culprit (of the gross alpha result, not the brain tumors) was deduced by some keen observations to be the short half-life radium isotope 224Ra, which had decayed to a stable 208 Pb lead isotope by the time of the analysis composited samples, but was present in the tapwater. USEPA considered issuing a rule on 224Ra and decided that it was not a priority at that time for several reasons. First, mandating it would be a hardship on states who must complete the analysis within 48–72 hours in order to backcalculate the original concentration of 224Ra. The additional expense for a fast turnaround analysis and the problem of laboratory capacity was a telling factor. In addition, the risk of 228 Ra is 8 times more radiotoxic than 224Ra, and already includes the effect of 224 Ra on the body, as it is in the decay chain. A quick turnaround gross alpha containing 224Ra would count the 224 and its progeny. The progeny would contribute approximately 3 times the 224Ra level present. But because the risk of 224Ra contains the effect of its daughters, the committed dose, the gross alpha count with daughters of 224Ra would overstate by threefold the 224Ra count and apparent health effects of the gross alpha count. Additionally, 224Ra would not likely be present if its greatgrandparent 228Ra were not present. Although there is a fairly insoluble 228Th in between, the USEPA=USGS reconnaissance survey demonstrated a close correlation between the presence of 228Ra and 224Ra, as might be expected. Therefore, systems who know that they have 228Ra and 224Ra, but do not want to monitor and analyze for 224Ra, might multiply their 228Ra result by 3 and add this to the gross alpha result to show what the gross alpha result might be if a fast turnaround sample were taken. The 224Ra level could roughly be taken as equal to 228Ra, and the 224Ra risk added to the 226Ra risk and any other gross alpha emitters present to determine the total risk from net alpha emitters. Given a 1 : 1 relationship between 228Ra and 224Ra, if 228Ra were 5 pCi=L, 224Ra would be at 5 pCi=L also and contribute only 13% of the total radium risk. Additionally, treatment to remove 228Ra alone or in combination with 226 Ra would also remove 224Ra to the same extent. Treatment is normally well below the MCL, leaving the risk from 224Ra small. 13.7.4

Uranium

In 2000, USEPA regulated for the first time the naturally occurring uranium isotopes in drinking water. Natural uranium (‘‘U-nat’’) is fairly ubiquitous, occurring in rocks rich in silica such as granites and the sediments and metamorphic rocks derived from them. U-nat consists of three isotopes: 238U, 235U, and 234U. The crustal abundance of 238U is by far the greatest by weight, constituting 99.275% of the uranium found. Uranium-235 is next being 0.72% by weight, followed by 234U, a greatgranddaughter in the decay chain of 238U, a distant third at 0.005%. One microgram of uranium with these relative isotopic proportions has an activity of 0.67 pCi=mg. The radioactivity of the three uranium isotopes, however, presents a different story. Uranium 238, the top of the uranium decay series, has a long half-life of

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4.5 billion years, and while its mass is 99.275%, its radioactivity represents only 48.9% of the total activity from natural uranium. Uranium 235, the head of the actinium decay series, has a 710-million-year half-life, and is 2.25% of the total activity. Uranium-234, although tiny in mass, has a high radioactivity and contributes 48.7% of the total radioactivity from uranium, an amount of activity almost equivalent to that of 238U. Because of its (relatively) short half-life of 250,000 years, it has a high radioactivity per weight, called specific activity. So, while 234U is uncommon in terms of mass, it represents about half the activity because it is so ‘‘hot.’’ In rock, the activity : mass ratio is 0.67, while in water the ratio is more variable, ranging from 0.77 to over 2 and generally around 0.9, where the activity is over 3.5 pCi=L. The reason is that a greater amount of 234U winds up in groundwater in part because of faster decay and the ‘‘alpha recoil’’ allowing 234U atoms to be ejected from the crystal matrix of the mineral into the surrounding water. USEPA established an MCLG, the health-based goal, of zero by virtue of its ionizing radiation. This was proposed in 1991 and finalized in 2000. In setting the enforceable limit, the MCL for uranium, USEPA had to decide to regulate it on the basis of its mass, its activity, or both. USEPA chose mass, but this decision was a circuitous, iterative process. Deciding the MCL was complicated by the fact that there are two endpoints of concern for uranium: heavy-metal toxicity affecting the kidneys, and cancer from radiation. Cancer is a potential effect, and any regulation of uranium had to recognize the carcinogenic effect of the element. The Agency intended that any regulation must stay within the 104–106 risk range. Despite this, cancer in humans has not been observed resulting from exposure to natural uranium, although it has been seen in animal studies using enriched, more radioactive species of uranium. For natural uranium, with its abundance of 238U, the toxicity of the heavy metal outweighs the cancer concern. The proposed MCL in 1991 was selected in the following manner. The proposal utilized a 1949 study of rabbits by Maynard and Hodge (1949) that found a 2.8 m k1 day1 dose to be the LOAEL. Dividing by a 1000-fold uncertainty factor (10 for interspecies, 10 for human variability, 10 for a less than lifetime study, 1 for LOAEL to NOAEL) resulted in an RfD of 0.003 m k1 day1. Multiplying by 70 kg divided by 2 L=day resulted in a DWEL of 100. Multiplying by a default RSC of 20% from drinking water converted to micrograms yielded an MCLG of 20 mg=L. By the time of the 2000 rule, the data had changed. USEPA selected the MCL in the following way. A panel of scientists expert in uranium health effects from the United States and Canada met in Washington in June 1998 for two days to discuss the available studies. Data by Gilman et al. (1998) from male rats resulted in a LOAEL of 0.06 after histopathologic examination of changes to the proximal tubule of the nephridium. This study was selected as the best evidence of damage from uranium in drinking water. The panel utilized a 100-fold uncertainty factor [10 for human variability: 3 for interspecies (animal to human), 3 for LOAEL to NOAEL, and 1 for a less than lifetime study], resulting in an RfD of 0.2 m kg1 day1. Multiplying by the standard factors of 70 kg and dividing by

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2 L=day consumption (95 percentile) resulted in a DWEL of 20 mg=L. However, new data by Fisenne and Perry (1985) and Fisenne and Welford (1986) on uranium consumption resulted in a new RSC value of 77% rounded to 80%. The resulting 16.8 mg=L was rounded to 20 mg=L which was the same as the proposed 1991 level arrived at via newer data. USEPA then utilized occurrence data to predict the number of water systems that would be out of compliance with various concentrations. While 20 mg=L is achievable, it could not be justified in USEPA’s opinion. A best estimate [between the lognormal distribution for the data and utilizing the data as directly reported in the National Inorganics and Radionuclides Survey (NIRS)] indicates that 850 systems would be affected at an annual cost of over $90 million to treat to 20 mg=L, while treating to 30 mg=L would affect only 500 systems (mainly small groundwater) at a cost of about $50 million annually. USEPA used a 1 : 1 activity : mass ratio to predict the benefits from the number of cancer cases and deaths avoided by regulation at different levels. Calculations could be made on the basis of cancer, but kidney toxicity was not quantifiable. The data do not provide a dose–response continuum from no effect, to cellular abnormalities, to frank effects and actual disease. But by using cancer risk numbers, cancer deaths are predictable. The excess cancer cases nationally at 20 pCi=L (equivalent to 20 mg=L) were predicted to be 0.9 resulting in 0.6 deaths. Going from about 20 pCi=L of radioactivity to about 30 pCi=L or 30 mg=L increases cancer deaths from 0.7 to 0.9, an incremental increase in 0.2 statistical deaths. The statistical valuation of a life is approximately 6 million, and the incremental lost health benefits of regulating at 30 mg=L calculates to a cost of a million dollars. When compared to the additional costs of about $40 million annually for regulating at the lower concentration, justifying the costs was difficult. Approximately 42% of national compliance costs and 20% of cancer risk reduction occur between 20 and 30 pCi=L. At 20 pCi=L the benefits are $4 million in avoided cancer deaths; at 30 pCi=L it is $3 million. In scrutinizing the data and the rationale for selecting 20 as the noncancer no-effect level for uranium, it was apparent that there was considerable safety built into the number. Selecting 30 mg=L would not have a demonstrably greater adverse effect on human health. The safety factors coupled with an assumption of 70 years of drinking uranium tainted water at 2 L=day all lead to a very conservative no-effect level. However, it is not apparent at what point some clinical effect would occur. Within these parameters of data and uncertainty, safety factors and cost, USEPA selected a limit it deemed both protective and practical and within the SDWA legal framework. The 1986 amendments to SDWA mandated a list of 83 contaminants be regulated, which included radon and uranium. This regulation also fit the new criteria established in the 1996 amendments in Section 1412(b)(1): that the contaminant may have an adverse effect on the health of persons and it is known to occur or there is a substantial likelihood that it will occur with a frequency and level of public health concern and its regulation represents a meaningful opportunity for health risk reduction. Therefore, when reviewing the best approach for regulating the contaminant, we attempted to regulate to maximize risk reduction at a cost that could be justified

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by the benefits recognizing that there are intangible and unquantifiable benefits from protection from kidney toxicity. The statute Section 1412(b)(6) gives the USEPA Administrator the authority to select a limit the cost of which is justified (not offset) by the benefits. When those benefits from toxicity and cancer were taken together, they did not, in the opinion of the Agency, justify the costs involved. A number that maximizes public health protection at a cost justified by the benefits was selected. For uranium, 30 mg=L did that. And, because the Agency was regulating it for the first time, not revising an MCL, the provision to maintain or provide greater protection than a previous MCL was not a factor. Initially, USEPA considered a dual standard for uranium, which recognized both kidney toxicity and cancer, specifically, a limit of both 30 mg=L and 30 pCi=L. However, discussions over the activity : mass ratio and conversions from one to another, the chemical methods approved for drinking water analysis, and the costs to community water systems, led to a decision to select one parameter to regulate. Because gross alpha was already an MCL and measured in pCi=L, our MCLG was based on cancer from radiation, and as this was a radionuclides rule, it seemed logical to select radioactivity as the units of the MCL. However, it was soon apparent that the approach had flaws. Regions where the activity : mass ratio was low, limiting activity to only 30 pCi=L could result in an equivalent mass of 45 mg=L. While toxicologists were willing to admit that all factors considered, their best scientific judgment would support 30 mg=L, an MCL that would allow up to 45 was not acceptable. We analyzed additional data demonstrating that rarely was an activity to mass ratio of 1 : 1 exceeded at levels we were regulating. By regulating in micrograms, it served as a limit on the picocurie concentration as well.

13.7.5

Beta and Photon Emitters

The SDWA authorizes the rules applicable to public water systems to be written according to specific criteria. The limits also affect other aspects of U.S. water policy. The Comprehensive Environmental Response, Compensation and Liability Act (CERCLA) or ‘‘Superfund’’ as amended by the Superfund Amendments and Reauthorization Act (SARA) makes the drinking water limits relevant and appropriate for cleanup at Superfund sites. CERCLA specifically refers to maximum contaminant level goals as relevant and appropriate for cleanup, and the National Contingency Plan interprets the cleanup levels to be MCL’s for contaminants whose MCLGs are zero. Implementation of one law requires the use of the product (MCL) of the other law. Policymakers in other agencies argued for higher standards in the revised radionuclides regulations for beta and photon emitters because drinking water standards also used as cleanup criteria did not factor in the high costs of cleaning aquifers. However, the SDWA does not allow consideration of Superfund cleanup costs in setting drinking water standards, which are based on health effects and treatment feasibility at public water systems. The SDWA considers relatively clean source waters have been contaminated, and requires an MCLG and establishment of BAT

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for removing the contaminant to a feasible level, the MCL, in a water treatment plant context. Superfund cleanup is very different from municipal water treatment. Yet, if the water is consumed, the health effect is the same and the safe level should be the same. That is precisely why CERCLA refers to SDWA goals and standards for selecting cleanup levels. Undeniably, the costs can be high, but USEPA allows considerable and reasonable flexibility in establishing a cleanup goal based on commonsense factors such as natural attenuation, and technological infeasibility realities. There is no need to attempt to sidestep the intent of Congress in SDWA and CERCLA in a rulemaking by making allowances not intended. Section 1412(b)(3)(C)(i)(III) specifically provides that USEPA is to analyze [q]uantifiable and nonquantifiable costs for which there is a factual basis in the rulemaking record to conclude that such costs are likely to occur solely as a result of compliance with the maximum contaminant level, including monitoring, treatment and other costs and excluding costs resulting from compliance with other proposed or promulgated regulations (emphasis added).

The argument that the costs of clean-up of groundwater contamination to achieve drinking water standards ought to be factored into the development of the standards themselves was rejected by the Court. Drinking water standards are referenced in CERCLA but what defines a safe drinking water level of a contaminant and what is feasible for public water systems to achieve should exclude costs associated with compliance with regulatory regimes other than the SDWA itself. . . Furthermore, CERCLA itself imposes no requirement that EPA consider the costs and benefits of compliance with MCLs as an element of clean-up standard, and certainly no requirement that the agency do so as part of its obligations under a separate statute like the SDWA (Waukesha v. EPA 2003)

In addition, the standard selected for drinking water is also relevant for setting standards for allowable contamination from long-term disposal of radionuclides at such sites as Yucca Mountain, Nevada, and decommissioning of Nuclear Regulatory Commission (NRC)-regulated sites. The Agency has a decade old policy through several Administrations of protecting ground water to drinking water standards. Underground sources of drinking water, whether they are current or future sources, are an extremely valuable resource that should be protected from degradation. The fact that future underground sources of drinking water would arguably be protected to drinking water standards proved a source of debate during deliberations for Yucca Mountain geologic repository for spent nuclear fuel and high-level waste. The Energy Policy Act of 1992 gives USEPA responsibility to set site-specific health and safety standards for Yucca Mountain. Because the radionuclides rule sets the amounts of contaminants allowed in the drinking water, it potentially affects the licensing of the site by the NRC, and the design and operation of the site by the Department of Energy to limit the human-made (synthetic) radionuclides that will eventually leak from the repository, if and when it is ever built. Should a clean

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source of future drinking water be allowed to be degraded by operation of a facility? Or should design considerations take into account preservation of the resource to avoid imposing unreasonable cleanup burdens on future generations? Rational public policy is embodied in the law. The lesson of the Superfund is that an ounce of prevention is worth a ton of cure. The extent of cleanup at facilities does consider the background levels of natural contaminants already at the site. In the case of synthetic nuclides, the background is clearly at zero. Thus a limit for them is already an allowance to increase contamination from zero up to a selected MCL, rather than the usual case of decreasing contamination down to an MCL. In this sense the standards selected for the beta and photon emitters were not based on a goal of zero and the feasibility of treatment, which could be much lower, but the original conceptual ceiling of excess deaths of one in a million per year. Revision of the standards according to the SDWA would result in lower limits than now. Treatment feasibility is not an issue and neither is cost to public water systems, there being few impacted at this time. USEPA engaged in discussions with the Office of Management and Budget (OMB), Department of Defense (DOD), NRC, DOE, and others relative to revising the part of its drinking water rule concerning the limit on the synthetic radionuclides in drinking water. A higher allowed limit would make the task of decommissioning power plants or licensing future facilities easier based on projections of ground water quality available to future consumers years from now. A stricter standard would make licensing more costly and unsure for Yucca Mountain. USEPA determined the risks of each of the synthetic contaminants regulated using the most recent model of Federal Guidance Report (FGR) 13. The original ceiling of risk in 1976 was to have been 5.6
105, but 25 contaminants exceeded this limit. However, rather than lowering those 25 to the intended risk ceiling, some were pressing for increasing the remaining contaminants up to that cap. Alternatively, some inside and outside the Agency urged changing from 4 mrem to 4 mrem EDE. Using the units of effective dose equivalent, most contaminants increased their concentrations substantially. The associated increase in risks convinced policymakers that this was not a good idea. In the end, the decision was to retain the existing limits, that is 4 mrem and the corresponding picocurie limits. However, USEPA did correct omissions and errors in calculations. A total of 179 synthetic beta and photon emitters are regulated. After the radionuclides rule was published, petitioners and USEPA discussed the elements of their petition before going to the Court to adjudicate. During this time, the agency was preparing the Yucca Mountain rule and discussions pertaining to the beta particle and photon emitters were raised, having relevance to both rules. The limit applying to drinking water systems would also serve as limiting factors for drinking water contaminated by the Yucca Mountain repository. Should the current units and limits be used or units of 4 mrem EDE with correspondingly higher limits be used? That weighting factors to account for differences in effects on the cells was good science and not in dispute though the EDE units had been superceded themselves by even newer science. But, the issue was that it would translate into higher individual drinking water limits for almost all nuclides regulated since 1976. In this case, scientific issues were clouded by how the issue was framed and presented.

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Pejorative phraseology of ‘‘new and better science’’ versus ‘‘old, bad science’’ became the currency of dialogue in discussions of what the numbers ought to be. Under the guise of the purity of better science, the cry for newer units was, in fact, all about raising the allowable limits of residual man-made radiation in the drinking water. In the final analysis, what really mattered was not the newness of the science, but its proper application and the results it achieved. The application of good science should be to increase, not decrease, protection. The technology for removing contaminants closer to the public health goal gets better over time, not worse. Could USEPA legally, in light of the SDWA mandates, abandon the protections embodied in the existing limits under the rubric of ‘‘good science’’? Using 4 mrem EDE would result in over 90% of the nuclides exceeding the 1
104 risk ceiling. In contrast, about the same percent of the nuclides at current limits fell below 104 and above 106 risk range as demonstrated by FGR-13. Use of equivalent units, like changing 72 F to 22 C or changing 4 mrem to 0.9 mrem EDE would not work equitably in this case because 0.9 was only the average of the regulated nuclides. Individual concentration limits would increase or decrease to line up with the new limit and nobody liked that result. In addition, those who would prefer uniform risks were not willing to set a sum of the fractions of risks at a 106 level because, as the Court pointed out, EPA could not achieve the uniformity for which petitioners argue without lowering most of the 1976 beta/photon MCLs until they yield a risk level actually provided by the most protective of those MCLs – a result petitioners do not seek and that would defeat their aim in bringing this petition. (Waukesha v. EPA 2003)

With respect to good science, USEPA defended the use of Federal Guidance Report No. 13 as reflecting ‘‘the best available, peer reviewed science and supporting studies conducted in accordance with sound and objective scientific practices’’ [SDWA Sec. 1412(b)(3)(A)]. The effective dose equivalent unit from 1991 is in reality based on 27-year-old organ weighting concepts embodied the International Commission on Radiological Protection’s effective dose equivalent (EDE) Publications 26 and 30. FGR-13 uses the concept of organ-specific risk, the basis of the organ weighting factors employed in calculating the effective dose equivalent. It also goes a step further, using the Blue Book for estimation of radiogenic risk; developing gender- and age-specific risk coefficients accounting for water consumption, radionuclide intake, and physiological and anatomic changes with age. It also uses the most recent biokinetic and dosimetric models recommended by the ICRP, 1990 vital statistics, best information radiogenic human health effects from the National Academy of Sciences and other groups, and updated life tables from the National Center for Health Statistics to adjust risk estimates for competing causes of death. The model is clearly superior to the 1991 model, but for all its sophistication it simply pinpoints the actual numerical risk. However, SDWA asks only about the movement of the MCL. If the number is retained or decreases, protection is maintained or improved. The previous model was inaccurate, but improving risk estimation is not central to the rulemaking. Keeping the MCL under the risk ceiling of 104

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is important, but this is not the MCLG. The newer model reinforced the underlying truth that concentration matters. Besides issues of the MCL itself, there were larger issues about at what point in a contaminated plume must water actually meet the standard? Should it apply to public water systems or individual well owners? The longstanding policy of protecting the resource would argue for the single private well, but in the case of Yucca Mountain, application of the MCL was as far out as 10,000 years under the law but far beyond that in reality. The size of the population and the distance to that population and the presumed dilution en route were major topics of discussion. Since the SDWA concerns public water supplies, applying the MCL to a public-water-sized system is reasonable but here reasonable people differed. A compromise position was reached applying the MCL at a point where people could be reasonably expected to consume the water and at a quantity of use by a reasonable-sized population drawing a large enough portion of uncontaminated water along with contaminated portions of the aquifer that together would meet the MCL. On June 6, 2001, one day shy of 7 months after the final rule for radionuclides in drinking water was published, USEPA finalized a rule regarding environmental standards to be applied at the Yucca Mountain site. The tension between setting a drinking water standard according to the law, and application of that standard in protection of drinking water sources from synthetic contamination far into the future was resolved, but not without considerable discussion and compromise to retain the spirit of the law and apply it in commonsense ways. The final rule is being challenged in court, so the debate will continue on to a legal resolution.

13.8

FUTURE OUTLOOK

How does regulation development become as entangled as it did for radionuclides? One reason certainly is the complexity of the subject that crosses many disciplines and viewpoints. An attorney may understand some of the science, but be excused for being unaware of the finer points or unique aspects of health effects or physics. The health physicist glazes over at intricacies of the law. An agency with a keen interest in a certain outcome and its own authority can easily forget that other competing interests and complementary legislative authorities exist alongside their own. The public wants healthy water, and the industry wants indemnity from future liability. Cleanup for a decommissioned facility is certainly cheaper at 400 pCi=L than 20 pCi=L. It is a simple matter of economics as are so many things. Is that necessarily wrong? No, managing scarce resources wisely means that tradeoffs must be made. Why should a contaminant in drinking water be limited when risks may appear to be much greater elsewhere? First, the law requires it. With better knowledge of relative risks perhaps the focus will shift to other pressing risks as well. Second, however, is that something can be done about identified risks to health from contaminants in drinking water despite other risks that cannot be changed. Lawmakers must fit different pieces of legislation together as they are created or amended into the overall risk reduction puzzle so that the eventual set of require-

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ments is harmonious. Future laws should continue to insist that better science leads to better, not worse, public health protection. Regulators do the law’s bidding. The challenges, conflicts, and opportunities experienced in regulating radionuclides will continue to reflect the diversity of interpretations and viewpoints involved with science, technology, law and politics, government, industry, and the consumer in a democratic society.

ACKNOWLEDGMENTS The author wishes to thank the individuals on the USEPA radionuclides work group for their exceptional work and devotion to a sensible standard, to good science, to safe drinking water.

REFERENCES City of Waukesha v. EPA,___ F.3d___, 2003 WL 431867 (D.C.Cir. Feb 25, 2003). Congress. 1995. Senate Report 104-169 (Nov. 7, 1995). Washington, DC: U.S. Government Printing Office. Congress. 1996. House of Representatives Report 104-632 (June 24, 1996). Washington, DC: U.S. Government Printing Office. Covello, V. T. 1992. Risk communication: An emerging area of health communication research. Communication Yearbook, 15. edited by S. Deetz. Newbury Park and London: Sage Publications. Covello, V. T. 1983. The perception of technological risks: a literature review. Tech. Forecasting Social Change, 23:285–297. Covello, V. T. and M. W. Merkhofer. 1994. Risk Assessment Methods. Plenum Press: New York. Fisenne, I. M. and P. M. Perry. 1985. Isotopic U concentration in human blood from New York City donors. Health Physics 49:1272–1275. Fissenne, I. M. and G. A. Welford. 1986. Natural uranium concentrations in soft tissues and bone of New York City residents. Health Physics 50:739–746. Focazio, M. J., Z. Szabo, T. F. Kraemer, A. H. Mullin, T. H. Barringer, and V. T. DePaul. 1998. Occurrence of Selected Radionuclides in Ground Water Used for Drinking Water in the United States: A Targeted Reconnaissance Survey. Water Resources Investigations Report 00_4273. Denver, CO: U.S. Geological Survey. Gilman, A. P., D. C. Villeneuve, V. E. Secours, A. P. Yagminas, B. L. Tracey, J. M. Quinn, V. E. Valli, and M. A. Moss. 1998. Uranyl nitrate: 28-day and 91-day toxicity studies in the Sprague-Dawley Rat. Toxicol. Sci. 41:117–128. Maynard, E. A. and H. C. Hodge. 1949. Study of toxicity of various uranium compounds when fed to experimental animals. In Pharmacology and Toxicology of Uranium Compounds. C. Voegtlin and H. C. Hodge, eds. National Nuclear Energy Series, Div. VI, Vol. 1. New York: McGraw-Hill. NRC. 1983. Risk Assessment in the Federal Government: Managing the Process. National Academy Press: Washington, DC.

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Powell, D. 1996. An Introduction to Risk Communication and the Perception of Risk. University of Guelph, Guelph, Ontario, Canada. http:==www.foodsafetynetwork.ca=risk= risk-review=risk-review.htm Sandman, P. M. 1987. Risk Communication: Facing Public Outrage. EPA Journal 13:21. Slovic, P. 1986. Informing and Educating the Public about Risks. Risk Analysis, 6:403–415. USEPA. 1991. National Primary Drinking Water Regulations; Radionuclides; Proposed Rule. Fed. Reg. 56:138:33050–33127. USEPA. 1999. Federal Guidance Report 13, Cancer Risk Coefficients for Environmental Exposure to Radionuclides. EPA 402-R-99-001. Washington, DC: Office of Radiation and Indoor Air. USEPA. 2000a. National Primary Drinking Water Regulations; Radionuclides; Notice of Data Availability; Proposed Rule. Fed. Reg. 65:78:21576–21628. USEPA. 2000b. National Primary Drinking Water Regulations; Radionuclides; Final Rule. Fed. Reg. 65:236:76708–76753. USEPA. 2001. Radionuclides Rule: A Quick Reference Guide. EPA 816-F-01-003. Washington, DC: Office of Water. USEPA. 2002a. Radionuclides in Drinking Water: A Small Entity Compliance Guide. EPA 815-R-02-001. Washington, DC: Office of Ground Water and Drinking Water. USEPA. 2002b. Implementation Guide to Radionuclides. EPA 816-D-00-002. Washington, DC: Office of Water.

14 RISK-BASED FRAMEWORK FOR FUTURE REGULATORY DECISION MAKING MARK GIBSON Program Officer, National Research Council, Water Science and Technology Board, Washington, DC

MICHAEL OSINSKI Drinking Water Utilities Team Leader, Office of Ground Water and Drinking Water, U.S. Environmental Protection Agency, Washington, DC

14.1

INTRODUCTION

The provision of safe drinking water throughout the United States has been a major triumph in U.S. public health practice since the beginning of the twentieth century. The quality and reliability of this service is vital because it simultaneously provides a life-giving substance to our communities while having the potential to deliver harmful substances and microorganisms if not properly maintained. Maintaining drinking water quality in the United States has been accomplished through several layers of continually evolving federal, state, and local government laws, regulations, and guidance designed to protect public water supplies from contamination. Despite overlapping regulatory protection, however, many water sources and treated public drinking water in the United States periodically contain chemical, microbiological, and other types of contaminants at detectable and sometimes harmful levels.

Drinking Water Regulation and Health, Edited by Frederick W. Pontius. ISBN 0-471-41554-5 # 2003 John Wiley & Sons, Inc.

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Annual manufacture and use of thousands of new chemicals that can reach water supplies and the discovery of emerging microorganisms that potentially can resist traditional water treatment practices or grow in distribution systems pose a regulatory dilemma: Where and how should the U.S. government focus its attention and limited resources to ensure safe drinking water supplies for the future? The widespread availability of increasingly powerful analytical methods for their detection and identification often serves to complicate these decisions. Regardless, the continuing presence of contaminants in water supplies, as well as documented outbreaks of waterborne disease and the many other outbreaks thought to go undetected, send a clear message that continuing public health vigilance is necessary to ensure that drinking water contaminants, including newly identified ones, are appropriately addressed. Certainly the most important, comprehensive, and widely enforced law designed to protect the public from hazardous substances in drinking water is the Safe Drinking Water Act (SDWA). As discussed in earlier chapters, the SDWA was enacted in 1974, authorizing the U.S. Environmental Protection Agency (USEPA) to establish federal (enforceable) standards to protect the public from harmful contaminants in drinking water. Since its enactment, the SDWA has been amended several times but most significantly in 1986, 1996, and 2002. This chapter reviews the important scientific and policy aspects of implementing the requirements mandated by the 1996 SDWA Amendments with respect to how drinking water contaminants are currently regulated and will be regulated in the United States for the foreseeable future. Specifically, a detailed discussion is provided regarding the Drinking Water Contaminant Candidate List (CCL), an overview of the development of the first (1998) CCL, the implementation status of the 1998 CCL, and most importantly, how future CCLs should be created and used effectively to regulate drinking water contaminants in the future. Much of this chapter originates and builds on select findings and recommendations of three successive reports of the National Research Council (NRC) Committee on Drinking Water Contaminants reports that were largely commissioned to assist USEPA in this enormous, complex task.

14.2

SDWA AMENDMENTS OF 1996

In 1996, after much debate and discussion, Congress amended the SDWA to provide increased funding and emphasize public health protection. The full text of the SDWA as amended appears in Appendix D. Notably, the amended SDWA significantly restructured the existing framework for regulating new drinking water contaminants and reviewing existing drinking water standards established under the 1986 SDWA amendments. Under the 1986 SDWA amendments, USEPA was required to establish drinking water standards within 3 years for 83 priority contaminants that the Agency had identified for study, and develop standards for 25 new Drinking Water Priority List (DWPL) contaminants every 3 years. The 1996 amendments to SDWA improved the standard setting

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process by establishing a new risk-based focus for setting contaminant regulation priorities based on the adverse health effects of the contaminant, the occurrence of the contaminant in public water systems, and the opportunities for tangible reduction in health risk that would result from regulation. Specifically, Section 1412 of the amended SDWA requires the USEPA to ‘‘publish a list of contaminants, which, at the time of publication, are not subject to any proposed or promulgated national primary drinking water regulation, which are known or anticipated to occur in public water systems, and which may require regulation under this title.’’ This list, known as the Drinking Water Contaminant Candidate List—more commonly referred to by the acronym CCL or DWCCL—provides the basis for a mandated USEPA decision to regulate (or not) at least five new contaminants every 5 years. Moreover, each CCL is also used to prioritize related drinking water contaminant research and occurrence monitoring activities within USEPA. The first CCL was to be published within 18 months of enactment, and updated every 5 years thereafter. In addition, the 1996 SDWA amendments require USEPA to give priority to selecting contaminants for inclusion on future CCLs that present the greatest public health concern, taking into consideration the effect of such contaminants upon subgroups that comprise a meaningful portion of the general population (such as infants, children, pregnant women, the elderly, individuals with a history of serious illness, or other subpopulations) that are identifiable as being at greater risk of adverse health effects due to exposure to contaminants in drinking water than the general population [SDWA Sec. 1412(b)(1)(c), as amended].

In essence, USEPA must use each CCL development process to help ensure that vulnerable subpopulations have access to safe drinking water. Thus, Congress, through the 1996 amendments, clearly mandated that the future of regulating drinking water contaminants in the United States will be through a riskbased approach by the regular creation and use of CCLs by USEPA to target and prioritize contaminants for possible regulatory action. SDWA Section 1401(6) states ‘‘The term ‘contaminant’ refers to any physical, chemical, biological, or radiological substance or matter in water.’’ This definition has not been revised since the inception of the SDWA in 1974, and is so broad as to include nontoxic and potentially beneficial ‘‘contaminants.’’ The 1996 SDWA amendments require USEPA to regulate such a contaminant when [SDWA Sec. 1412(b)(1)(A)] (i) the contaminant may have an adverse effect on the health of persons; (ii) the contaminant is known to occur or there is a substantial likelihood that the contaminant will occur in public water systems with a frequency and at levels of public health concern; and (iii) in the sole judgment of the Administrator, regulation of such contaminant presents a meaningful opportunity for health risk reduction for persons served by public water systems.

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Furthermore, the amended SDWA allows USEPA to issue interim regulations for any drinking water contaminant that is determined to pose an ‘‘urgent threat’’ to human health without adhering to the newly revised process for making regulatory decisions (i.e., the CCL process) or completing a cost=benefit analysis [SDWA Sec. 1412(b)(1)(d)]. Hence, to select a contaminant for regulation, USEPA must eventually determine whether the contaminant meets the preceding SDWA criteria for regulation, or if the contaminant represents an urgent threat to public health. Does the contaminant have or may have an adverse health effect? Does it occur, or is it likely to occur in drinking water? Is there a meaningful opportunity for risk reduction if a regulation is established? Answering these questions is difficult.

14.3 ROLE OF THIRD-PARTY CONSULTATION IN SDWA REGULATORY DEVELOPMENT USEPA relies on expert advice and analysis from organizations outside the agency, referred to as ‘‘third parties,’’ throughout the regulatory development process. Two such third-party groups are the NRC and the National Drinking Water Advisory Council (NDWAC). Both of these groups have played an important role in the development of the CCL. 14.3.1

The National Research Council (NRC)

The National Academy of Sciences (NAS) was established in 1863 under a charter granted by Congress. NAS organized the NRC in 1916 to serve as the principal operating agency of both the National Academy of Sciences (NAS) and the National Academy of Engineering (NAE). The NRC, NAS, and NAE further knowledge and provide services to the government, the public, and the scientific and engineering communities. Together with the Institute of Medicine (IOM), all four organizations are now collectively known as The National Academies. Section 1412(e) of the 1974 SDWA mandated that the NRC conduct studies to identify adverse health effects associated with contaminants in drinking water, to identify relevant research needs, and to make recommendations regarding such research (NRC 1977). Subsequent amendments to the SDWA requested revisions of the NRC study and have mandated additional reports. Between 1977 and 1989, the NRC published a total of nine reports in a series called Drinking Water and Health covering a wide variety of issues related to drinking water safety, including toxicology, dose–response relationships, and risk assessment. In addition to this seminal series of reports, the NRC has continued to periodically release important reports on drinking water issues and specific contaminants. A complete listing of NRC drinking water reports is provided in Chapter 4. In late 1997, USEPA requested NRC to provide advice regarding the setting of priorities among drinking water contaminants in order to identify those contaminants that pose the greatest threats to public health as required by the 1996 SDWA amend-

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ments. In response, the NRC Committee on Drinking Water Contaminants was formed in early 1998 and consisted of volunteer experts from academia, state and federal government, and private industry with expertise in public water system operations, water treatment engineering, public health, epidemiology, toxicology, water and analytical chemistry, risk assessment, risk communication, and aquatic microbiology. The committee’s activities were conducted in two discrete phases over a 3-year study period (Feb. 1998 through July 1999 and Aug. 1999 through Feb. 2001) to address two distinct sets of related tasks and issues. Three reports were released during the two phases addressing the following aspects of the study:
Developing a scientifically sound approach for deciding whether to regulate contaminants on the current and future CCLs and how to prioritize CCL contaminants for further research or monitoring (Phase I)
Convening a workshop that focused on emerging drinking water contaminants and the database that should be created to support future decision making on such contaminants (Phase I)
Creating a scientifically sound approach for developing future CCLs (Phase II) Setting Priorities for Drinking Water Contaminants (NRC 1999a) addresses the first of these topics, Identifying Future Drinking Water Contaminants (NRC 1999b) addresses the second, and Classifying Drinking Water Contaminants for Regulatory Consideration (NRC 2001) addresses the last. Collectively these reports address issues directly and indirectly related to the three central aspects of the study; many are noted or discussed in some detail within this chapter.

14.3.2

The National Drinking Water Advisory Council (NDWAC)

The NDWAC was chartered under the 1974 SDWA to provide independent advice and recommendations to USEPA on drinking water issues and related SDWA policies and is an approved advisory committee that operates under the authority of the Federal Advisory Committee Act (USEPA 1999c). It advises the Administrator on key aspects of the USEPA’s drinking water program. The NDWAC is composed of members representing the general public, state and local agencies, and private groups concerned with safe drinking water. Several working groups were formed within NDWAC after the 1996 SDWA amendments to help USEPA implement many of its new and revised statutory requirements. During the development of the first CCL, USEPA relied heavily on the advice and recommendations of the now-disbanded NDWAC Working Group on Contaminant Occurrence and Contaminant Selection. This group consisted of engineers, microbiologists, toxicologists, and public health scientists from government agencies, water utilities, and other stakeholder groups. USEPA has also looked to NDWAC for recommendations for developing decisionmaking protocols for making regulatory decisions once contaminants are placed

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on the CCL, and to its Working Group on Research for support in developing a Comprehensive Research Strategy.

14.4

ROLE OF USEPA PROGRAMS

In accordance with the 1996 amendments, developing future CCLs will be coordinated and closely linked with two other drinking water programs: (1) the National Drinking Water Contaminant Occurrence Database (NCOD); and (2) the unregulated contaminant monitoring (UCM) program. The relationship of both of these programs to the CCL in terms of their mandated timelines is illustrated in Figure 14.1 (USEPA 1998a, NRC 2001). Implementing all three programs is the responsibility of USEPA’s Office of Ground Water and Drinking Water (OGWDW). USEPA completed the first working release of the NCOD and the UCM Rule (UCMR) prior to its amended SDWA statutory deadline of August 1999. 14.4.1 National Drinking Water Contaminant Occurrence Database (NCOD) The NCOD stores occurrence data for both regulated and unregulated drinking water contaminants throughout the United States. It is designed to support agency efforts

Figure 14.1 Current and future timeline for selected major regulatory requirements of the SDWA amendments of 1996 [source: adapted from USEPA (1997b), NRC (1999a, 2001)].

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to identify and select contaminants for placement on future CCLs; conduct related research, monitoring, and regulatory activities; and periodically reviewing existing drinking water regulations every six years for possible modification, as required under the amended SDWA (USEPA 2000b, NRC 2001). Two additional purposes are to inform the public about contaminants detected in drinking water and make available the data sets that are used by USEPA to help form the primary basis for their drinking-water-related regulatory and research actions. The design, structure (e.g., data elements), and use of the NCOD were developed with input from the public, states, and the scientific community (USEPA 1997b). The first release of the NCOD became operational in August 1999 (as mandated) and included occurrence data (both detections and nondetections) on various physical, chemical, microbial, and radiological contaminants found in public water systems (PWSs) and ambient (source) water (USEPA 2000b). More specifically, it contained some summary statistics of PWS data stored in USEPA’s Safe Drinking Water Information System (SDWIS) and ambient water stored in the National Water Information System (NWIS) of the U.S. Geological Survey (USGS). The second release of NCOD became operational in late August 2000 and included several changes intended to increase its functionality such as the availability of an NCOD User’s Guide (USEPA 2000c). Despite these ongoing improvements, USEPA has reported several self-assessed data limitations (e.g., does not contain occurrence data from every PWS or from every state) and cautions to NCOD users (e.g., although data sets are updated over time, they may still reflect a lag time of at least 6 months from data provided directly from a PWS) (USEPA 2000b). For more information about the NCOD and its development status, go to http:==www.epa.gov=ncod=. 14.4.2

Unregulated Contaminant Monitoring Program

Section 1445 of the 1996 SDWA amendments required USEPA to substantially revise its previous regulations for unregulated contaminant monitoring (see Title 40, Code of Federal Regulations, Part 141) (USEPA 1999a, 1999d, 1999e; NRC 2001). The major requirements of the program include: (1) developing of a new list of UCM contaminants every 5 years; (2) monitoring by all large PWSs (i.e., serving >10,000 persons) and a representative sample of ‘‘small’’ PWSs (i.e., serving 10,000 persons or less); (3) placing of the monitoring data in the NCOD, and (4) providing public notification to consumers that monitoring results are available. The 1996 amendments also limit the number of unregulated contaminants that a PWS must monitor in any given period to a maximum of 30 and require USEPA to pay the reasonable costs of analyzing the samples taken by small systems. USEPA will use data generated by the UCM regulation to: (1) evaluate and rank contaminants on the first (1998) CCL (see further discussion below) and help develop future CCLs; (2) support determinations of whether to regulate specific contaminants under the drinking water program; and (3) support the ongoing development of drinking water regulations (NRC 2001). The final UCM rule replaced almost all of the existing monitoring requirements of the existing UCM rule when it took effect on January 1, 2001.

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Drinking Water Research Plan

Since the publication of the first CCL in March 1998, USEPA has made significant progress in establishing an overall CCL research strategy and associated schedule. The overriding goal of USEPA’s drinking water research program is to provide sufficient information for the Administrator to make regulatory determinations for CCL contaminants as mandated by the amended SDWA. More specifically, this research is intended to identify the scientific and engineering data needed, and to characterize the risks posed by individual 1998 CCL contaminants. Several recommendations from Setting Priorities for Drinking Water Contaminants (NRC 1999a) were incorporated by USEPA in the Agency’s CCL Research Plan (USEPA 2000a, NRC 2001). USEPA ultimately decided on a two-phase approach to form the basis for the 1998 CCL Research Plan (USEPA 2000a). Phase I is a screening level process in which individual CCL contaminants are evaluated with regard to their available analytical methods, health risk, and treatment information to determine if a contaminant should be moved directly into the regulatory determination priorities category of the CCL or moved into Phase II of the Research Plan (NRC 2001). In Phase II, a more thorough examination of the available data is conducted to determine whether an individual contaminant should be recommended for regulation, guidance development, or whether a recommendation not to regulate should be made. In summary, Phase II research involves the creation of a comprehensive database for each CCL contaminant on its available health effects, analytical methods, occurrence, exposure, and treatment options. The CCL Research Plan was developed by USEPA in close consultation and with the extensive input of several outside stakeholders, including the American Water Works Association (AWWA), the AWWA Research Foundation (AWWARF), other government agencies (e.g., Centers for Disease Control and Prevention), universities, and other public and private sector groups (USEPA 2000a). Furthermore, several expert workshops were organized and conducted to not only help develop the 1998 CCL but also identify preliminary research needs for specific contaminants. In this regard, USEPA endeavors to make all aspects of 1998 CCL research planning, implementation, and communication a collaborative process through a series of public workshops and stakeholder meetings—including the activities of the NDWAC Working Group—that will be held periodically in the coming years. Two key challenges face USEPA to ensure that adequate research is conducted to support sound regulatory decisions: 1. Mechanisms must be found to leverage funding support across governmental and nongovernmental agencies. It is almost certain that USEPA’s current and future drinking water program budget cannot alone sustain the depth and breadth of research on CCL contaminants that is necessary to meet the SDWA mandated deadlines. 2. USEPA must make research planning an ongoing process that commits to the CCL, a coordinated effort between program offices within the agency and other federal or state agencies and industry stakeholders.

14.5 DEVELOPMENT OF THE FIRST CCL

14.5

347

DEVELOPMENT OF THE FIRST CCL

As noted previously, the SDWA amendments of 1996 require USEPA to publish the CCL, a list of unregulated contaminants and contaminant groups every 5 years that are known or anticipated to occur in public water systems and that may require regulation. This list, the CCL, will provide the basis for USEPA decisions to regulate (or not) at least five new contaminants every 5 years, as indicated in Figure 14.1. Furthermore, as additional research or monitoring was needed for most of the contaminants on the 1998 CCL, each successive CCL will also be used to help prioritize such activities (NRC 1999a). For these reasons, the CCL will play a central and recurring role in the foreseeable future of drinking water contaminant regulation in the United States, notwithstanding future Congressional action to amend SDWA’s standard setting provisions. USEPA published the first draft CCL on Oct. 6, 1997 (USEPA 1997a), and the first final CCL on March 2, 1998 (USEPA 1998a). The draft 1998 CCL included 58 unregulated chemical and 13 microbiological contaminants and related contaminant groups and was made publicly available for comments in the Federal Register (USEPA 1997a, 1998b). Notably, the chemical contaminants were further divided into ‘‘preliminary data need’’ categories such as those requiring additional health effects data but not occurrence data. The 1998 CCL (USEPA 1998a) contains 60 contaminants and contaminant classes, including 10 microbial contaminants and groups of related microorganisms and 50 chemicals and chemical groups, as alphabetically listed in Table 14.1. A total of four microorganisms and eight chemicals and chemical groups were removed from the draft 1998 CCL while one chemical and one broad group of related microbial contaminants were added. USEPA relied extensively on the recommendations and advice of the NDWAC Working Group on Occurrence and Contaminant Selection for developing the draft 1998 CCL. Modifications to the draft CCL were also reviewed and formally approved by the full NDWAC prior to publication of the final 1998 CCL. USEPA acknowledged that the ‘‘first CCL is largely based on knowledge acquired over the last few years and other readily available information, but an enhanced, more robust approach to data collection and evaluation will be developed for future CCLs’’ (USEPA 1997a). Several public commenters on the draft CCL also noted the need for a more systematic and scientifically defensible approach to selecting contaminants for future CCLs (USEPA 1998b). Development of the 1998 CCL and its limitations have been described in detail (NRC 1999a, 1999b, 2001), especially various sociopolitical issues surrounding the development of future CCLs. To a large extent, the widespread recognition of these limitations contributed to the formation of the NRC Committee on Drinking Water Contaminants to advise USEPA on setting regulatory and research priorities for the first (1998) and subsequent CCLs, and the creation of future CCLs.

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TABLE 14.1 1998 Drinking Water Contaminant Candidate List (CCL) Microorganisms Acanthamoeba (guidance) Adenoviruses Aeromonas hydrophila Caliciviruses Coxsackieviruses Cyanobacteriaa (blue-green algae), other freshwater algae, and their toxins Echoviruses Helicobacter pylori Microsporidia (Enterocytozoon and Septata) Mycobacterium avium intracellulare Chemicals 1,1,2,2-Tetrachloroethane 1,2,4-Trimethylbenzene 1,1-Dichloroethane 1,1-Dichloropropene 1,2-Diphenylhydrazine 1,3-Dichloropropane 1,3-Dichloropropene 2,4,6-Trichlorophenol 2,2-Dichloropropane 2,4-Dichlorophenol 2,4-Dinitrophenol 2,4-Dinitrotoluene 2,6-Dinitrotoluene 2-Methyl-phenol (o-cresol) Acetochlor Alachlor ESA and other acetanilide pesticide degradation products Aldrin Aluminum Boron Bromobenzene DCPAc monoacid degradate DCPA diacid degradate DDEd Diazinon Dieldrin Disulfoton Diuron EPTCe Fonofos Hexachlorobutadiene

CASRNb 79-34-5 95-63-6 75-34-3 563-58-6 122-66-7 142-28-9 542-75-6 88-06-2 594-20-7 120-83-2 51-28-5 121-14-2 606-20-2 95-48-7 34256-82-1 N=A 309-00-2 7429-90-5 7440-42-8 108-86-1 887-54-7 2136-79-0 72-55-9 333-41-5 60-57-1 298-04-4 330-54-1 759-94-4 944-22-9 87-68-3

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TABLE 14.1 (Continued ) p-Isopropyltoluene (p-cymene) Linuron Manganese Methyl bromide Metolachlor Metribuzin Molinate MTBEf Naphthalene Nitrobenzene Organotins Perchloratea Prometon RDXg (1,3,5-trinitrohexahydro-striazine) Sodium Sulfate Terbacil Terbufos Triazines and degradation product of triazines (including, but not limited to Cyanizine [21725-46-2], and atrazine-desethyl [6190-65-4]) Vanadium

99-87-6 330-55-2 7439-96-5 74-83-9 51218-45-2 21087-64-9 2212-67-1 1634-04-4 91-20-3 98-95-3 N=A N=A 1610-18-0 121-82-4 7440-23-5 14808-79-8 5902-51-2 13071-79-9 N=A

7440-62-2

a

Added after publication of draft CCL. Chemical Abstracts Service Registry Number. c (Dacthal)dimethyl-2,3,5,6-tetrachlorobenzone-1,4-dicarboxylate. d 1,1-Dichloro-2,2-bis(p-dichlorophenyl)ethylene. e S-Ethyl dipropylthiocarbamate. f Methyl-tert-butyl ether. g Royal Dutch explosive. b

Source: USEPA (1998a).

14.6

PUBLIC HEALTH DECISIONS FROM THE 1998 CCL

USEPA recognized that sufficient data are necessary to analyze the extent of exposure and risk to populations ( particularly for vulnerable subpopulations) via drinking water for each CCL contaminant in order to determine appropriate regulatory action (USEPA 1998a, 2000a). If sufficient data are not readily available, additional data must be obtained before any meaningful assessment can be made for a specific contaminant or contaminant group. In this regard, a major intended function of a CCL is to help prioritize research and monitoring needs for drinking water contaminants of regulatory concern. Once a CCL is developed, all contaminants are divided into one or more future action (‘‘next step’’) categories that are used to

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help set the research priorities for USEPA’s drinking water program (see Fig. 14.2). Notably, there has been periodic reassignment of contaminants between categories since publication of the first CCL as additional data have been obtained and evaluated. The ‘‘regulatory determination priorities’’ category includes those contaminants considered to have sufficient data to evaluate both exposure and risk to public health that will support a regulatory decision (USEPA 2000a). Contaminants in this category were used to select five or more contaminants for which USEPA was required to make a determination to regulate or not by August 2001. In June 2002, USEPA announced a preliminary decision to not regulate all nine CCL contaminants that were included in this category (USEPA 2002). Final determinations are still pending. Although the first CCL is essentially a list of research and monitoring needs for several dozen drinking water contaminants, to be included on the list, contaminants had to pass a relatively rigorous screening process involving assessment of existing contaminant occurrence and health effects data recommended by a group of experts (the NDWAC Working Group on Occurrence and Contaminant Selection). Furthermore, a variety of stakeholders, including representatives of the water utility industry and public interest groups, provided comments on the draft CCL, and the final list was revised accordingly. Thus, the contaminants on the first CCL and future CCLs are likely to have a much higher likelihood of posing public health risks in drinking water than would a randomly assembled list of unregulated substances and microorganisms. However, key questions remain for USEPA in how to best determine which contaminants should be moved off this research list and when sufficient health, occurrence, and treatment data warrant making a regulatory decision for both the first and future CCLs.

Figure 14.2

The 1998 CCL and next steps [source: adapted from USEPA (1999b, 2000a)].

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The first CCL began as an essentially unranked list of research needs for drinking water contaminants; that is, additional research and monitoring is needed for most of the contaminants on the current CCL as indicated in Figure 14.2. USEPA faces a complex and ongoing task of (1) assessing the available scientific information on individual contaminant risks; (2) making risk management decisions (based on such assessments) regarding which contaminants should be removed from the CCL through regulation, guidance development, or no further action; and (3) how to prioritize remaining CCL contaminants for further research or monitoring (NRC 1999a). 14.6.1 Applicability of Prioritization Schemes for CCL Contaminants Many government agencies and private industries have developed a number of schemes since the early 1980s that rank chemicals according to their importance as environmental contaminants. However, there are no equivalent schemes for microbial contaminants existing at the time the report was written. Upon reviewing many of these schemes, NRC (1999a) concluded that a ranking process that attempts to sort or prioritize contaminants is not appropriate for the selection of drinking water contaminants from the CCL for regulation, monitoring, or research. In the absence of complete information, the output of such simple quantitative ranking processes is so uncertain (although this uncertainty is generally not stated) that they are of limited use in making more than preliminary risk management decisions about drinking water contaminants of concern. However, the report did conclude that several existing methods and approaches for ranking environmental contaminants could prove to be useful if modified to sort large numbers of potential drinking water contaminants to be considered for inclusion on future CCLs. 14.6.2

Generalized Decisionmaking Framework

As noted above, a ranking algorithm may to appropriate to help determine contaminants to list on the CCL, but such an approach was deemed unsuitable for determining the appropriate disposition of contaminants on the CCL (NRC 1999a). Rather, the decisionmaking process requires considerable expert judgment throughout to address (1) uncertainties from the inevitable gaps in information about exposure potential or health effects, (2) evaluate the many different health effects that contaminants can cause, and (3) interpret available data in terms of statutory requirements. Therefore, such decisions necessarily involve subjective judgments, and the amended SDWA designates USEPA to make them. For each contaminant on a CCL, there are three possible outcomes of USEPA’s decision process: 1. Consider for regulatory action, as required by the 1996 SDWA amendments, if information is sufficient to judge that a contaminant ‘‘may adversely affect public health’’ and ‘‘is known or is substantially likely to occur in public water systems with a frequency and at levels that pose a threat to public health.’’

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2. Drop from the CCL if information is sufficient to determine that the contaminant does not pose a risk to public health in drinking water. 3. Conduct additional research on health effects or occurrence=exposure if information is insufficient to determine whether the contaminant should be regulated. These three outcomes are not necessarily exclusive. For example, based on available evidence, USEPA could decide to initiate regulatory action for a particular contaminant and issue a health advisory, while simultaneously pursuing research to fill information gaps that might result in subsequent further modifications of the regulatory level. Figure 14.3 shows a simplified illustration of the general decision process NRC (1999a) recommended that USEPA use in deciding which of the three outcomes (or combinations thereof) listed above is appropriate for each contaminant on a CCL. The right side of the figure provides a suggested timeline to progress through each step of the process in order to help the Agency allocate their limited time and resources to meet the statutory requirements of the SDWA for the development and use of the first and successive CCLs. Notably, the recommended framework applies to both chemical and microbiological contaminants; differences in either their characteristics or the information available about them do not justify separate decision processes (as used to identify potential contaminants for inclusion on the draft 1998 CCL) (USEPA 1997a).

Figure 14.3 Recommended phased process decisionmaking process for setting priorities among contaminants on a CCL [source: adapted from NRC (1999a)].

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Steps that NRC (1999a) recommended in the decision process are summarized as follows:
After publication of a final CCL, conduct a three-part assessment for each CCL contaminant to include (1) health effects data (to include effects on vulnerable populations), (2) exposure data, and (3) existing data on analytical methods and treatment options. An important component of the three-part assessments will be policy judgments by USEPA about the significance of the available data.
After completing the three-part assessment, USEPA should conduct a preliminary risk assessment for each CCL contaminant on the basis of the available data identified in the three-part assessment. Each risk assessment should be conducted, even if there are data gaps, to provide a basis for an initial decision about the disposition of the contaminant under consideration and to guide research and monitoring efforts, where needed.
Issue a separate decision document for each for each contaminant describing the outcome of the preliminary risk assessment (i.e., whether the contaminant will be dropped from the CCL because it does not pose a risk, will be slated for additional research or monitoring, or will be considered for regulation).
Issue a health advisory for each contaminant not dropped from the CCL after the preliminary risk assessment. (Health advisories are discussed in Chapter 6. Although recommended by NRC, this step is not necessarily practical from USEPA’s perspective because of resource limitations.)
Compile a regulatory package for contaminants to be removed from the CCL or conduct research and=or monitoring for each contaminant remaining on the CCL after the preliminary risk assessment. For contaminants not selected for a regulatory decision, such research and monitoring results should be fed back into another preliminary risk assessment, and new decision documents should be issued on the basis of the results of these subsequent risk assessments. Decisions to drop a contaminant from the CCL, to issue a health advisory or to proceed toward regulation should be based on public health risk considerations only, also indicated on Figure 14.3. However, filling data gaps in treatment technologies and analytical methods is needed to avoid delaying regulatory action for contaminants posing a public health threat. Involvement of all interested parties is important, and should include regulated utilities, state and local regulators, public interest representatives, and consumers (NRC 1999a). For example, public comments on the preliminary regulatory determination will offer independent perspectives and can ensure that criteria developed after consideration of all the relevant issues have not been overlooked. In the long run, considering the views of stakeholders will likely lead to a more transparent and less contentious regulatory development process. NRC did not provide or recommend use of a mechanistic tool (i.e., one free of policy judgments) for assessing contaminants. Indeed, the need for policy judgments by USEPA cannot and should

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not be removed from this process. Ultimately, USEPA is accountable to the public for the decisions it makes about regulating drinking water contaminants. In making these decisions, common sense should be the guide and decisions should err on the side of public health protection. 14.6.3

NDWAC Regulatory Decisionmaking Protocols

The NDWAC was also asked for advice on specific protocols to assist the Agency in making regulatory determinations for both chemical and biological contaminants on the current and future CCLs. Separate protocols were developed for chemicals and microbes, using the three statutory requirements of SDWA Section 1412(b)(1)(A)(i)–(iii) as the foundation for guiding USEPA in making regulatory decisions. These protocols identify specific factors for consideration and define the relative significance and weight that should be given to inform decision-making. Although the protocols do not explicitly score or rank contaminants, they provide a consistent approach to evaluate contaminants for regulatory determinations, and organize the data underlying regulatory determinations in a logical, rational, and transparent fashion for public review (USEPA 2002). To address the issue of whether a contaminant may have adverse effects on the health of persons, NDWAC recommended that USEPA characterize the health risk and estimate a health reference level (HRL) for evaluating the occurrence data for each CCL contaminant. To evaluate the ‘‘known or likely occurrence of a contaminant,’’ NDWAC recommended that USEPA consider (1) the known or estimated national percentage of PWSs with detections above half the HRL, (2) known or estimated national percentage of PWSs with detections above the HRL, and (3) the geographic distribution of the contaminant. To address whether regulation of a contaminant presents a ‘‘meaningful opportunity for health risk reduction,’’ NDWAC recommended that USEPA consider estimating the national population exposed above half the HRL and the national population exposed above the HRL. To determine whether a pathogen poses a human health risk, NDWAC recommended assessment of the known treatment effectiveness of current treatment practices. If a pathogen is controlled by drinking water treatment techniques currently in place to comply with existing regulatory requirements, then a decision not to regulate would be appropriate. If a pathogen is not controlled by such practices, the protocol considers the following factors in assessing the risk of adverse health effects: (1) whether the pathogen is frank or opportunistic; (2) the concentration of the infective dose; (3) the duration of illness, and extent of secondary spread; (4) the method of detection; (5) the immune status of the host (i.e., sensitivity of vulnerable subpopulations), and (6) the long-term immunity conferred by exposure. Finally, if it is unknown whether the pathogen can be controlled by existing technology, the pathogen should be integrated into research track for further study. To assess a pathogen’s occurrence and exposure, the decisionmaking protocol examines the natural history of the organism, to include the existence of resistant

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forms of the pathogen, its survivability in water and the host, the geographic distribution of the organism, and the extent of human and=or animal reservoirs for the organism. The determination of whether regulating the pathogen presents an opportunity for meaningful health risk reduction depends on whether current or pending regulations fail to provide adequate risk reduction, and there are no recognized indicators or surrogates that can be used to demonstrate the effectiveness of treatment in controlling the organism. 14.6.4

Regulatory Decisions from the 1998 CCL

USEPA developed and applied its evaluation approach to be consistent with the recommendations from NRC and NDWAC (USEPA 2002). The Agency evaluated the adequacy of current analytical and treatment methods, the best available peer reviewed science on health effects, and approximately 7 million analytical data points on contaminant occurrence. For those contaminants with adequate monitoring methods, as well as health effects and occurrence data, USEPA employed an approach to assist in making preliminary regulatory determinations that follows the themes recommended by the NRC and NDWAC to satisfy the three SDWA requirements under Section 1412(b)(1)(A)(i)–(iii). USEPA characterized the human health effects that may result from exposure to the contaminant of concern and estimated either an HRL or a benchmark value for each contaminant (USEPA 2002). For contaminants considered to be human carcinogens or likely to be human carcinogens, data on the mode of action of the chemical were assessed to determine the method of low dose extrapolation. When this analysis indicates that a low dose extrapolation is needed and when data on the mode of action are lacking, USEPA used a default low dose linear extrapolation to estimated oral exposures associated with incremental risk levels that range from one excess cancer per 10,000 people (104) to one cancer in a million (106). A 106 risk-specific concentration was selected as the HRL for this assessment. For CCL chemicals not considered to be carcinogenic to humans, USEPA generally calculated a reference dose (Rf D), corresponding to a daily oral exposure to the human population (including sensitive subgroups) that is likely to be without an appreciable risk of adverse health effects during a lifetime (Barnes and Dourson 1988). It can be derived from a ‘‘no-observed-adverse-effect level (NOAEL),’’ ‘‘lowest-observed-adverse-effect level (LOAEL),’’ or benchmark dose, with uncertainty factors generally applied to reflect limitations of the data used. A Benchmark Dose (BMD) is usually defined as the lower statistical confidence limit for the dose corresponding to a specified increase in the level of health effect of concern over the background level (Crump 1984). Please refer to Chapter 7 for a discussion of uncertainty factors that may be applied, and also to Gibson et al. (1997) for a review of noncancer risk assessment approaches for the use of deriving drinking water criteria. For each CCL contaminant, USEPA estimated the number of PWSs with detections greater than one-half the HRL and greater than the HRL, the population served

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at these benchmark values, and the geographic distribution using a large number of state occurrence data (approximately 7 million analytical points) that broadly reflect national coverage. If a benchmark value was used instead of an HRL, the same process was carried out with one-half the benchmark value and the full benchmark value. Use and environmental release information, as well as ambient water quality data, were used to augment the state data and to evaluate the likelihood of contaminant occurrence. The findings from these evaluations were used to determine if there was adequate information to evaluate the three SDWA statutory requirements and to make a preliminary determination of whether to regulate a contaminant. Table 14.2 provides the preliminary regulatory decisions with supporting HRLs and occurrence and exposure information.

14.7

DEVELOPMENT OF FUTURE CCLs

As noted previously, the CCL will be reviewed and updated by USEPA at least every 5 years. Also, the Agency is required to make determinations to regulate or not regulate for at least five contaminants on each list. In preparing the 1998 CCL, the Agency essentially did the best it could given the short timeframe to meet the statutory deadlines, with the intention of developing a more robust process for developing future CCLs. 14.7.1

Identifying Future Drinking Water Contaminants

The NRC Committee on Drinking Water Contaminants held deliberations following a series of presentations given at a December 2–4, 1998, workshop on emerging drinking water contaminants in Washington, DC. A report was prepared (NRC 1999b) that included papers on individual and groups of related emerging chemical and microbiological drinking water contaminants, analytical and treatment methods, and existing and proposed environmental databases for their proactive identification, research, and potential regulation. Following the presentations, the committee developed a conceptual consensus-based approach for the creation of future CCLs. This conceptual approach for developing future CCLs involves a two-step process (NRC 1999b). First, the ‘‘universe’’ of potential drinking water contaminants, derived from a wide variety of sources, would be first combined and culled using simple criteria and expert judgment to prepare a ‘‘preliminary CCL’’ (PCCL). In this regard, NRC recommends evaluation of several types of related potential drinking water contaminants that were not considered for inclusion on the first CCL, such as pharmaceuticals, biological toxins, and fibers. Next, the PCCL would be processed, using more information in conjunction with a semiquantitative screening tool and expert judgment, to prioritize which contaminants should be listed on the CCL to drive research and regulatory efforts. The process would be repeated every five years for each CCL development cycle to account for new data and as emerging drinking water contaminants are identified. Finally, all contaminants that have not been regu-

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0.02% (2 of 12,165) 0.09% (11 of 11,788) Round 1: 0.16% (20 of 12,284) Round 2: 0.08% (18 of 22,736) 6.1% (60 of 989) 0% (0 of 13,512) Round 1: 0.01% (2 of 13,452) Round 2: 0.01% (2 of 22,923) 22.6% (224 of 989) 4.97% (819 of 16,495) — Microbes

Chemicals

Systems >12HRL

0.02% (2 of 12,165) 0.09% (11 of 11,788) Round 1: 0.11% (14 of 12,284) Round 2: 0.02% (4 of 22,736) 3.2% (32 of 989) 0% (0 of 13,512) Round 1: 0.01% (2 of 13,452) Round 2: 0% (0 of 22,923) 13.2% (131 of 989) 1.8% (295 of 16,495) —

Systems >HRL

0.02% (8700 of 47.7 M) 0.07% (32,200 of 45.8 M) Round 1: 0.57% (407,600 of 71.6 M) Round 2: 2.3% (1.6 M of 67.1 M) 4.6% (68,100 of 1.5 M) 0% (0 of 50.6 M) Round 1: 0.007% (5600 of 77.2 M) Round 2: 0.002% (1700 of 67.5 M) 18.5% (274,300 of 1.5 M) 10.2% (5.2 M of 50.4 M) —

Population >12HRL

Source: Adapted from USEPA (2002).

Population >HRL

0.02% (8700 of 47.7 M) 0.07% (32,200 of 45.8 M) Round 1: 0.37% (262,500 of 71.6 M) Round 2: 0.005% (3100 of 67.1 M) 2.6% (39,000 of 1.5 M) 0% (0 of 50.6 M) Round 1: 0.007% (5600 of 77.2 M) Round 2: 0% (0 of 67.5 M) 8.3% (123,600 of 1.5 M) 0.9% (446,200 of 50.4 M) —

Diease incidence: Keratitis, 1.65–2.01 cases per year for contact lens wearers; GAE infection, 64 cases in the United States during 1957–1998.

Do not regulate, issue guidance to contact lens wearers

Acanthomoebaa

a

Do not regulate, update health advisory Do not regulate, issued health advisory

Do not regulate

Do not regulate

Do not regulate

Sodium (NIRS) Benchmark ¼ 120,000 mg=L Sulfate (R2) HRL ¼ 500,000 mg=L

Hexachlorobutadiene (R1, R2)s HRL ¼ 0.9 mg=L Manganese (NIRS) HRL ¼ 300 mg=L Metribuzin (R2) HRL ¼ 91 mg=L Naphthalene HRL ¼ 140 mg=L

Do not regulate

Do not regulate

Do not regulate

Preliminary Decision

Preliminary Regulatory Determinations from the First Contaminant Candidate List

Aldrin (R2) HRL ¼ 0.002 mg=L Dieldrin (R2) HRL ¼ 0.002 mg=L

Contaminant

TABLE 14.2

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lated or removed from the existing CCL would be automatically retained on each subsequent CCL. 14.7.2

Classifying Future Contaminants for Regulation Consideration

USEPA asked the NRC Committee on Drinking Water Contaminants to evaluate, expand, and revise as necessary the conceptual two-step approach to the generation of future CCLs. The agency also asked the NRC committee to explore the feasibility of developing and using mechanisms for identifying emerging microbial pathogens [using virulence factor–activity relationships (VFARs)] for research and regulatory activities. This latter topic is briefly discussed near the end of this chapter. In all three of its reports, NRC continues to emphasize the need for expert judgment throughout all CCL-related processes and for a conservative and commonsense-based approach that errs on the side of public health protection (NRC 1999a, 1999b, 2001). Further, the NRC believes that scientific disagreements about the public health effects of contaminants and their relative severity are the norm and do not signal a deviation from sound science. For example, when data are sparse for a particular emerging drinking water contaminant, they may often appear consistent and coherent, but data gaps and inconsistencies usually become evident as the contaminant is examined more fully by different methods and from different perspectives. Similar to evaluating CCL contaminants for appropriate regulatory activities (see NRC 1999a), USEPA faces a challenging and recurring task in assessing the available scientific information about potential drinking water contaminant risks and, on the basis of such assessments, making decisions about which contaminants should be placed on a CCL for future regulatory consideration. Throughout this process, there is no suitable replacement for the policy judgments that must be made by USEPA. Because of time constraints stipulated by the amended SDWA for publication of the first CCL, USEPA was forced to rapidly develop and utilize a decisionmaking process for the creation of the 1998 CCL. In general, the NRC felt that the process used to develop the first CCL, although appropriate for the pressing circumstances at the time, was not suitable for use as a long-term model (NRC 2001). Rather, the development process used for future CCLs should be made more defensible and transparent and take place with increased opportunities for public comment and input. The NRC (1999a) concluded that a ranking (i.e., rule-based) scheme that attempts to sort a relatively small number of drinking water contaminants already on a CCL in a specific order for regulation development, research, or monitoring is not appropriate. However, such ranking schemes may be useful for sorting larger numbers of potential contaminants to determine which ones should be included on future CCLs. Recognizing USEPA’s limited resources, the lack of a comprehensive list of potential drinking water contaminants, and poor or nonexistent data on health effects, occurrence, and other attributes of the vast majority of potential contaminants, the NRC (2001) again recommended that a two-step process be used for creating future CCLs, illustrated in Figure 14.4. Although the basic concept for

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Figure 14.4 Recommended two-step process for developing future CCLs [source: adapted from NRC (1999a, 2001)].

CCL development did not change, many recommendations and guidelines for its design and implementation were necessarily revised and expanded between the two study phases and in accordance with the last round of committee deliberations. In summary, a broadly defined universe of potential drinking water contaminants is first identified, assessed, and culled to a PCCL using simple screening criteria and expert judgment (NRC 2001). To create the corresponding CCL, all PCCL contaminants are then assessed individually using a ‘‘prototype’’ classification tool in conjunction with expert judgment to evaluate the likelihood that each could occur in drinking water at levels and frequencies that pose a public health risk. This two-step process should be repeated for each CCL development cycle to account for new data and potential contaminants that inevitably arise over time. Finally, all contaminants that have not been regulated or removed from the existing CCL should automatically be retained on each subsequent CCL. Sociopolitical Considerations Developing a PCCL from the universe of potential drinking water contaminants, as well as contaminant movement from a PCCL to its corresponding CCL, is a very complex task requiring numerous difficult classification judgments in a context where data are often uncertain, conflicting, or missing. Because of this inherent complexity, to be scientifically sound as well as publicly acceptable, the process for developing future CCLs must depart considerably from the process used to develop the first CCL (NRC 2001). Rather, designing and implementating process for selecting contaminants for future CCLs should be systematic, scientifically sound, and transparent, and involve sufficiently broad public participation.

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For example, transparency should be incorporated into the design and development of the classification and decisionmaking process for future CCLs, which is an integral component in communicating the details and results of the process to the public. Otherwise, the public may perceive the process as being subject to manipulation to achieve or support desired results. Thus, sufficient information should be provided so that interested persons can place themselves in a position similar to decisionmakers and arrive at their own reasonable and informed judgments and conclusions. In this regard, a central tenet of the NRC (2001) is that the public is, in principle, capable of making wise and prudent decisions and that this should be recognized by USEPA and reflected in the choice of public participation procedure to help create future CCLs. In contrast, a ‘‘decide–announce–defend’’ strategy that essentially involves the public only after the deliberation process is over is not acceptable. Regarding vulnerable subpopulations, the NRC recommends that not only should USEPA’s working definition of vulnerable subpopulations comply with the amended language of the SDWA (NRC 2001), but it should also be sufficiently broad to protect public health; in particular, USEPA should consider including (in addition to those subgroups mentioned as examples in the amended SDWA) all women of childbearing age, fetuses, the immunocompromised, people with an acquired or inherited genetic disposition that makes them more vulnerable to drinking water contaminants, people who are exceptionally sensitive to an array of chemical contaminants, people with specific medical conditions that make them more susceptible, people with poor nutrition, and people experiencing socioeconomic hardships and racial or ethnic discrimination.

Universe to PCCL Although the contaminants included on the first (1998) CCL certainly merit regulatory consideration, the NRC concluded that a broader approach to contaminant selection could potentially identify higher-risk contaminants. USEPA should begin by considering a broad universe of chemical, microbial, and other types of potential drinking water contaminants and contaminant groups (see Table 14.3). The total number of contaminants in this universe is likely to be on the order of tens of thousands of substances and microorganisms, given that the Toxic Substances Control Act inventory of commercial chemicals alone includes about 72,000 substances (NRC 1999b, 2001). This represents a dramatically larger set of substances and microorganisms to be considered initially than that used for the creation of the 1998 CCL. The Agency should rely on databases and lists that are currently available and under development, along with other readily available information, to begin identifying the universe of potential contaminants that may be candidates for inclusion on the first and subsequent PCCLs. For example, use of the Endocrine Disruptor Priority-Setting Database (ERG-USEPA 2000) should be considered to help develop future PCCLs (and perhaps CCLs). Although relevant databases and lists exist for many categories of potential drinking water contaminants, other categories

14.7 DEVELOPMENT OF FUTURE CCLs

TABLE 14.3

361

Universe of Potential Drinking Water Contaminants

Category Naturally occurring substances Biological toxins Fibers Microbial agents Naturally occurring agents in water Agents associated with human feces Agents associated with human and animal feces Agents associated with human and animal urine Agents associated with water treatment and distribution systems Chemical agents Commercial chemicals Pesticides Pharmaceuticals Cosmetics Food additives Water additives, including impurities Water treatment and distribution system leachates and degradates Products of environmental transformation of chemical agents Reaction and combustion byproducts Metabolites in the environment Radionuclides

Examplesa Arsenic, lead, nitrates, radon, terpines Aflatoxin, endotoxin Asbestos Legionella, toxic algae Enteric viruses, coxsackie B viruses, rotavirus Enteric protozoa and bacteria, Cryptosporidium, Salmonella Nanobacteria, microsporidia Biofilms, Mycobacterium

Chlorinated solvents, cumene, gasoline and additives trichloroethylene Atrazine, diuron, malathion Acetaminophen (analgesic), Diclofenac (antiinflammatory), ethynllestradiol (estrogen) Glycols, stearates Butylated hydroxyanisole, dyes, propylene glycol Aluminum, Rhodamine WT Trihalomethanes, vinyl chloride Deethylatrazine, trichloroacetic acid Anthracene, benzopyrene Dibutyltin, dimethylarsenic, methylmercury Iodine-131, radon, strontium-90

a Some examples can belong to more than one category of contaminant (e.g., enteric viruses might also be associated with animal feces).

Source: Adapted from NRC (1999b, 2001).

have no lists or databases (e.g., metabolites in the environment). Thus, a strategy should be developed by USEPA with public, stakeholder, and scientific community input, for filling the gaps and updating the existing databases and lists of contaminants for future CCLs. As an integral part of any development process for future PCCLs and CCLs, all information used from existing or future databases or lists should be compiled in a consolidated database to provide a consistent mechanism for recording and retrieving information on specific contaminants under consideration. Such a database could

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also serve as a ‘‘master list’’ that contains a detailed record of how the universe of potential drinking water contaminants was identified and how a particular PCCL and its corresponding CCL were subsequently created. Moreover, it would also serve as a powerful analytical tool for the development of future PCCLs and CCLs. It is also important that designing, developing, and implementing a consolidated database be done in open cooperation with the public, stakeholders, and the scientific community. To assist in identifying the universe of potential contaminants and a PCCL, substances should be considered based on their commercial use (e.g., use as a gasoline additive), environmental location (e.g., routinely stored in underground storage tanks), or physical characteristics (e.g., solubility). As inclusive an approach as possible should be used to narrow down the universe of potential drinking water contaminants for the PCCL. The NRC envisioned that a PCCL would include on the order of a few thousand individual substances and groups of related substances, including microorganisms, for evaluation and prioritization to form a CCL. However, the preparation of a given PCCL should not involve extensive analysis of data, nor should the PCCL itself directly drive USEPA’s research or monitoring activities. A Venn diagram approach (see Fig. 14.5) should be used to conceptually distinguish a PCCL from the broader universe of potential drinking water contaminants. However, because of the extremely large size of the universe of potential drinking water contaminants, well-conceived screening criteria must to be developed that can be applied consistently by the Agency in conjunction with expert judgment to

Figure 14.5 Conceptual approach using a Venn diagram to identify contaminants for inclusion on a PCCL (the sizes of the rings and intersections are not drawn to scale and should not be interpreted to represent an estimate of the relative numbers of contaminants in each area) [source: adapted from NRC (2001)].

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expeditiously cull that universe to a much smaller PCCL. Thus, the PCCL should include those contaminants that are demonstrated to occur or could potentially occur in drinking water and those that are demonstrated to cause or could potentially cause adverse health effects. To develop screening criteria for adverse health effects, human data and data on whole animals should be used as indicators of demonstrated health effects, while data from experimental models that predict biological activity and other toxicological data should be used as indicators of potential health effects. Many different metrics could be used to develop screening criteria for the occurrence of drinking water contaminants. These (NRC 1999a) include: (1) observations in tap water; (2) observations in distribution systems; (3) observations in the finished water of water treatment plants; (4) observations in source water; (5) observations in watersheds and aquifers; (6) historical contaminant release data; and (7) chemical production data. The first four should be used as indicators of demonstrated occurrence, and information from items 5–7 should be used to determine potential occurrence (NRC 2001). Each successive PCCL should be published to provide a useful record of past PCCL and CCL development processes and serve as a starting point for the development of future PCCLs. Development of the first PCCL should begin in time to support development of the 2003 CCL; and each PCCL should be available for public and other stakeholder input (especially through the Internet) and should undergo scientific review. PCCL to CCL The intrinsic difficulty of periodically deciding which potentially harmful substances or microorganisms to move from the PCCL onto a CCL raises the issue of what kind of process or method is best suited to this judgment. Indeed, the sorting of perhaps thousands of PCCL contaminants into two discrete sets—one (the CCL) that potentially will undergo research or monitoring of some sort preparatory to an eventual regulatory decision and another much larger set that will not—is an exercise in classification (NRC 2001). 14.7.3

Overview of Classification Strategies

Several approaches are available for classification of contaminants. The NRC considered three broad types of strategies for accomplishing this challenging task: expert judgment, rule-based systems, and prototype classifiers; the results of which are summarized in the following section. Expert Judgment USEPA has made regular and extensive use of expert committees—including the NRC Committee on Drinking Water Contaminants, advisory panels, peer review committees, and the like—to help its staff (itself an assemblage of experts) to help make important technical and policy decisions for their drinking water program (NRC 2001). The composition of any expert group in terms of expertise, membership, and organization affiliations is critical to the ultimate outcome of the group. Since the

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late 1990s, USEPA has made a concerted effort within to include a wide spectrum of ‘‘stakeholder’’ opinion in the expertise solicited. Of course, the outcome of any expert group may be influenced, though to a largely unknown extent, by the absence of persons who could not participate in such meetings for whatever reasons (NRC 2001). Even when external matters to the questions and issues at hand are removed or diminished, the internal dynamics of expert groups often influences their outcomes in crucial ways (NRC 2001). For example, the timing of when a particular subject comes up (e.g., at the beginning of a meeting vs. the end of the last day) or who advocates for or against a position (involving member persuasiveness, seniority, and status) can lead to very different outcomes for reasons not directly connected with the immediate issues. Furthermore, the presence or absence of USEPA experts and the relative intensity of their participation can frequently alter the direction of a discussion in important ways, for example, directing it toward or away from regulatory and policy concerns that may not be readily apparent in the minds of nonagency experts. For the same reasons, discussions of committees consisting solely of USEPA staff and their consultants are likely to have a very different character than those with significant or predominant participation from nonagency experts. One commonly adopted strategy to help neutralize or reduce these types of effects is to use a formal Delphi procedure (NRC 2001). The seminal paper on the procedure by Webler and colleagues (Webler et al. 1991) and several other reports by the National Academies (IOM 1988, 1992, 1995; NRC 1988, 1992) describe the use of the Delphi procedure in clinical and environmental decisionmaking, respectively. A Delphi approach to assist in the selection of candidate drinking water contaminants for future CCLs is questionable (NRC 2001), but it remains a technique that potentially avoids some of the traditional pitfalls of expert-judgment-based methods of classification. Rule-Based Methods In broad terms, rule-based strategies use various features or parameters of an object as inputs, and these features are then weighed and combined according to an algorithm that is decided on in advance—usually as a result of expert judgment (NRC 2001). One common characteristic of both rule-based and expert systems is that their classification strategy is what is often called ‘‘Aristotelian,’’ where objects such as potential drinking water contaminants are assigned attributes (e.g., occurrence or toxicity), and a set of rules is prescribed and used to determine which class they are in (Bowker and Star 1999). Thus, they are essentially expert judgment strategies, in which the judgments are embedded a priori into a fairly rigid algorithm (NRC 2001). While this inherent rigidity can be considered a strength in that these classifications are objective and consistent and allow for widespread use, its weakness is they do not easily allow for additional nuanced judgment. Furthermore, even though the weights and modes of combining attributes used in a rulebased scheme are presumably determined using some preexisting idea or conceptualization of what the scheme intends to capture, it is often not performed in any systematic or transparent fashion.

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The NRC (NRC 1999a) reviewed 10 rule-based ranking schemes to establish priorities for their regulatory attention using available data for chemicals (including potential drinking water contaminants). At the time that report was written, there were no formal schemes for prioritizing microbial contaminants available for NRC review and comment. The rule-based systems were evaluated for their potential to help select drinking water contaminants (including microorganisms) that are already on a CCL for future action, such as development of regulations, research, or monitoring. On the basis of this review, all the schemes were found to have at least one major shortcoming (although many had several), but of special concern was the extent to which often arbitrary and nonexplicit expert judgments were intrinsically embedded in what initially appeared to be objective ranking schemes (NRC 2001). For example, the methods of weighting and combining attributes (e.g., additive or multiplicative) were all matters of judgment that were in place prior to the input of any data to the ranking system. Overall, the NRC committee concluded that a ranking process that attempts to sort contaminants in a specific order is not appropriate for the selection of drinking water contaminants already on a CCL for regulation, research, or monitoring activities (NRC 1999a). In the usual absence of complete information, the output of such prioritization schemes was found to be so uncertain (although this uncertainty is generally not stated) that they are of limited use in making more than preliminary risk management decisions about drinking water contaminants. In this regard, the committee concluded that rule-based ranking schemes may provide a (semi)quantitative means for preliminarily screening and sorting large numbers of contaminants. Developing an expert panel consensus framework might help increase the utility of a ranking=scoring system (Swanson and Socha 1997). A consensus framework would establish principles and guidelines to promote consistency in the development and use of chemical ranking and scoring systems.

Prototype Classification Methods The last classification strategy considered by the NRC is often referred to as ‘‘prototype classification’’ (Bowker and Star 1999). Such a strategy recognizes that in ordinary practice a person seldom classifies objects on the basis of a fixed algorithm, but instead uses criteria based on prior classification of examples, or ‘‘prototypes’’ (NRC 2001). A classic example of this phenomenon is recognition of an individual letter in the alphabet by its similarity to an idealized example rather than by any fixed features such as height : width ratios. In this way, prototype classifiers take advantage of the prototyping activity at which humans generally and intuitively excel. Prototype classification strategies usually incorporate neural networks, clustering algorithms, machine learning classifiers, and their hybrids. These related schemes begin with a known classification of prototypes (a ‘‘training set’’) that typify the kinds of outcomes one might wish to achieve. Such prototypes are then used to discern an algorithm that maps prototype attributes or features into specific classification outcomes. The prototype-based algorithm can then be used to classify new

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objects of interest. A more detailed discussion of the neural network paradigm used by NRC is available (NRC 2001). Application of a prototype strategy for creation of a future CCL would consist of identifying and using a training set of individual and related chemicals, microorganisms, and other types of drinking water contaminants that would clearly belong on the CCL, such as currently regulated chemicals (if not already regulated), and those that clearly do not, such as food additives generally recognized as safe by the U.S. Food and Drug Administration (FDA) (NRC 2001). Each contaminant’s attributes or features—such as solubility, various measures of toxicity (quantitative or categorical), and occurrence data, if any—must then be extracted and characterized. With such a training set, the neural network would be used to construct both the mode of combination and the weighting factors that seem to best differentiate between the two categories. Notably, prototype strategies have already found successful use in commerce, hazardous-waste disposal, environmental monitoring, and reliability analysis [e.g., see Keller et al. (1995)]. Which Strategy to Use? To date, USEPA has relied extensively on use of expert judgment and to a lesser extent on rule-based prioritization strategies to identify and rank drinking water contaminants for regulatory, research, and monitoring activities. Clearly, consideration of individual contaminants by panels of experts as to whether a particular substance or microorganism should be placed on a future CCL is not possible if the entire universe of potential drinking water contaminants is to be considered. Thus, the development of an efficient screening method is necessary. Until now, this has usually meant the use of an a priori ranking or classifying system. However, because none of the 10 schemes for ranking chemicals previously reviewed by NRC (NRC 1999a) were deemed suitable to fulfill this function readily (NRC 1999b), an existing scheme would have to be significantly modified or an entirely new one created. On the basis of its review, the NRC recommended that the development and use of a prototype classification strategy is an innovative approach that is worthwhile for USEPA to consider (NRC 2001). However, a potentially serious drawback of using a prototype classification strategy is its perceived lack of ‘‘transparency,’’ that is, the neural network can easily appear as a black box, with little obvious indication of how well it is ‘‘working.’’ While transparency in developing future CCLs and making public health decisions from them will be an important consideration, this transparency is not necessarily synonymous with simplicity. A CCL decisionmaking process that uses complex classification modeling can be made relatively transparent by emphasizing that the classification is based on prototypes of past regulatory decisions and should, thus, be readily defensible (NRC 2001). The difference in this regard from more conventional methods is perhaps misleading. There is little that is ‘‘transparent’’ or easily reproducible about expert judgment, for example. The ‘‘black box’’ in this case is the human brain. Such expert judgments still must be justified for regulatory purposes, but this is no different from what will be required as output from a neural network approach (NRC 2001). Ranking systems are only superficially transparent, in that the weights and modes

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of combination are explicit and open for all to see, but how the weights are arrived at and the consequences of the modes of combination usually are not. As for the neural network approach, its outputs must also be justified for regulatory purposes. The NRC (2001) recommended that USEPA give careful consideration to and actively experiment with developing a prototype classification approach using neural network or similar methods (in conjunction with expert judgment) to identify appropriate PCCL candidates for inclusion on the CCL. 14.7.4

PCCL to CCL: Attributes of Contaminants

Once an approach is selected to identify contaminants for inclusion on the PCCL, the second step of the CCL development process is to select PCCL contaminants for inclusion on the corresponding CCL through use of a prioritization tool in conjunction with expert judgment (NRC 1999b, 2001). In this regard, the PCCL may generally be thought of as a much more manageable and less conceptual list than the universe of potential contaminants. The PCCL is anticipated to contain up to a few thousand individual and groups of related substances and microorganisms that warrant further consideration for inclusion on the CCL. However, as nearly all of the contaminants on a PCCL are anticipated to have incomplete information on their potential occurrence and health effects, any process for selecting PCCL contaminants for inclusion on a CCL must recognize and overcome such limitations. Furthermore, the absence of information for a particular PCCL contaminant should not necessarily become an insurmountable obstacle to its inclusion on the CCL (NRC 1999b). Clearly, some amount of expert judgment will be required for the assessment and promotion of each PCCL contaminant to its corresponding CCL. The NRC’s recommended approach is to develop and use five attributes that contribute to the likelihood that a particular PCCL contaminant (or group of related contaminants) could occur in drinking water at levels and frequencies that pose a public health risk (NRC 2001). In conjunction with a process to exercise expert judgement, a scoring system for each of the five attributes would rank and select the highest priority PCCL contaminants for inclusion on a CCL. For health effects, the severity and potency were identified as key predictive attributes, while prevalence, magnitude, and persistence–mobility constitute the occurrence attributes. These five attributes are considered to be a reasonable starting point for USEPA, especially as they were subsequently found to convincingly demonstrate the utility of the CCL development approach (see further discussion below). Thus, the metrics and related considerations presented in that report (and as briefly discussed in this chapter) for scoring each attribute should be viewed as strictly illustrative. Indeed, the NRC does not explicitly or implicitly recommend these five (or that there should necessarily be a total of five) attributes and their related scoring metrics as being ideally suited for direct adoption and subsequent use. Rather, USEPA must develop and use a set of attributes (with public and other stakeholder input that will also undergo scientific review) to evaluate the likelihood that any particular PCCL contaminant or group of related contaminants could occur in drinking water at levels and frequencies that pose a public health risk.

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14.8 ILLUSTRATION OF A PROTOTYPE CLASSIFICATION SCHEME This section presents a mostly nonquantitative demonstration of how a prototype classification scheme for drinking water contaminants might work. Refer to the NRC (2001) for detailed information regarding the more complex mathematical and modeling parameters associated with the following illustrative prototype classification scheme. As noted previously, prototype classification schemes require a training data set. For illustrative purposes, the NRC constructed a training data set based on contaminants that are presumed worthy of regulatory consideration (T ¼ 1) and those contaminants that are not (T ¼ 0). The contaminants included in the training data set were then assigned values for the two health effects (severity, potency) and three occurrence attributes (prevalence) described previously. Notably, use of a prototype classification approach does not require that the contaminant attributes be the ones specified here for demonstration purposes. USEPA could decide to use fewer attributes or add entirely different attributes. The overall objective is to determine the drinking water contaminant attributes that comprehensively encompass the information needed to make an informed regulatory decision, while the modeling objective is to mathematically represent the mapping (function) between the contaminant attributes and the binary classification variable target value (T ). The most commonly used metric to evaluate the mapping function’s ability to capture the training data set is the mean-squared error. Use of a prototype classification approach allows for a great deal of choice in selecting the mapping function. The NRC (2001) presents results using two alternatives. The first is based on a linear function; the second is derived from a neural network architecture. For both alternatives, the training data set is used to ‘‘calibrate’’ the mapping function followed by the use of an appropriate criterion to determine the optimal threshold value for the classification variable that separates data into T ¼ 1, or T ¼ 0. A predicted value greater than the threshold would indicate that a particular contaminant belongs in the T ¼ 1 category, while a predicted value less than the threshold would indicate that the contaminant belongs in the T ¼ 0 category. Results of the NRC classification exercises and associated analyses were not intended to lead to definitive conclusions about any of the specific or groups of related chemicals and microorganisms discussed in the report. Indeed, the NRC committee was extremely limited in time and resources, the training data set used was much smaller than would be ideal, and the attribute scores are far from certain. Nonetheless, the exercise provides a valid and compelling demonstration of a prototype classification methodology that could ultimately serve as a framework for USEPA to conduct a similar analysis to help classify future PCCL contaminants for inclusion on the corresponding CCL. 14.8.1

The Training Data Set

The training data set constructed by the NRC committee (NRC 2001) consisted of a total of 80 individual and groups of related (organic and inorganic) chemicals and

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microorganisms, 63 of which were assigned to the ‘‘presumed worthy of regulatory consideration’’ category (T ¼ 1), and 17 of which were assigned to the ‘‘presumed not worthy of regulatory consideration’’ category (T ¼ 0). These are listed in Table 14.4. Those included in the T ¼ 1 category were selected from among those currently regulated drinking water contaminants that have enforceable maximum contaminant levels. Contaminants listed in the T ¼ 0 category are considered to be safe for human ingestion and many of these were taken from the list of substances ‘‘generally recognized as safe’’ (GRAS) by the U.S. Food and Drug Administration. Notably, the number of contaminants included in the table (especially the T ¼ 0 category) is less than would be desired, includes very few microorganisms, and contains primarily inorganic and organic chemicals. Thus, the size and types of drinking water contaminants (e.g., radionuclides) included in the training data set must ultimately be increased to improve the predictive capacity of any prototype classification method that it ultimately develops and uses. 14.8.2

Attribute Scoring

For each contaminant in the training data set (and for each of the validation and ‘‘interesting’’ test cases; see further discussion below), values between 1 and 10 were assigned to each of five total health effects and occurrence attributes a set ( NRC 2001). Contaminant attribute scores for chemicals and microorganisms used in the demonstration are considered rough estimates as they were assigned in a very rapid fashion using limited sources of health effects and occurrence data and information. Despite the considerable uncertainty in assigning attribute scores for contaminants in the training data set, the NRC made every effort to be as precise and consistent as possible within the timeframe allowed. This analysis provides some very valuable insights into the usefulness of the approach. 14.8.3

Prototype Classification Functions

The NRC compared two distinct prototype classification analyses: a linear classification function and a neural network architecture (NRC 2001). Employing a linear model is an attractive alternative because the mapping function is readily understandable and the values of the attribute weights are easy to interpret. In addition, calibrating a linear classification model can be done with very simple statistical procedures that are widely available. The disadvantage of the linear model is that its performance is poor if the training data are not ‘‘linearly separable,’’ as explained below. To achieve good performance with linearly nonseparable data, a model must be used that is capable of nonlinear dependencies. In contrast, neural networks provide the flexibility to capture linear as well as nonlinear dependencies (Hornik et al. 1989), were originally conceived in the 1960s, and became more formally developed in the 1980s. Their use has become increasingly widespread since the early 1990s, and a number of excellent textbooks have been written on the applications of neural networks in a variety of fields (e.g., Garson 1998, Weiss and Kulikowski 1990, Zupan and Gasteiger 1993), while Bailey and Thompson (1990) and Hinton (1992) are widely cited introductory

370

NRC Training Data Set Contaminants

Acrylamide Alachlor Benzene Benzo[a]pyrene Carbofuran Carbon tetrachloride Chlordane Chlorobenzene 2,4-Da Dalapon o-Dichlorobenzene p-Dichlorobenzene 1,2-Dichloroethane 1,1-Dichloroethylene cis-1,2-Dichloroethylene trans-1,2-Dichloroethylene Dichloromethane 1,2-Dichloropropane Di(2-ethylhexyl) phthalate Dinoseb Dioxin (2,3,7,8-TCDD)b Diquat Endothall Endrin Epichlorohydrin Ethylbenzene

Organic Chemicals

Antimony Barium Beryllium Cadmium Chromium (total) Cyanide Fluoride Mercury (total inorganic) Nitrite Selenium Thallium

Inorganic Chemicals

Presumed Worthy of Regulatory Consideration (T ¼ 1)

TABLE 14.4

Organic Chemicals Ascorbic acid Benzoic acid Citric acid Ethanol Folic acid Glucose Glycerin Glycine Olestra p-Aminobenzoic acid (PABA) Phosphate Propylene glycol Saccharin Vanillin

Microorganisms Legionella Heterotrophic plate count (HPC) Total coliforms Viruses

Calcium Chloride Iron

Inorganic Chemicals

Presumed Not Worthy of Regulatory Consideration (T ¼ 0)

371

b

2,4-Dichlorophenoxyacetic acid. 2,3,7,8-Tetrachlorodihenzo-p-dioxin. c 2,4,5-Trichlorophenoxyproprionic acid. Source: Adapted from NRC 2001.

a

Ethylene dibromide Glyphosate Heptachlor Heptachlor epoxide Hexachlorobenzene Hexachlorocyclopentadiene Lindane Methoxychlor Oxamyl (Vydate) Pentachlorophenol Polychlorinated biphenyls (PCBs) Simazine Styrene Toluene Toxaphene 2,4,5-TPc (Silvex) 1,2,4-Trichlorobenzene 1,1,1-Trichloroethane 1,1,2-Trichloroethane Trichloroethylene Vinyl chloride Xylenes (total)

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articles. In simplest terms, a neural network is a mathematical representation of a network of biological neurons, where input data are fed into the network, and output from the network is computed on the basis of the architecture of the network and the operative mathematical functions. One of the main advantages of using a neural network for a prototype classification approach is that it is not necessary to specify a priori the mathematical relationship between input and output data (NRC 2001). Rather, one chooses the architecture (the number of neurons and their organization) and the transfer functions operative at each information node. The more elaborate the architecture, the more flexible is the model in capturing the functionalities between input and output and the possibly numerous interactions in variables. However, it is precisely this advantage that often leads to the primary disadvantage of using neural networks— the resulting classification algorithm is not readily extracted, and there is a necessary loss in transparency in exactly how the input variables determine the classification output. Furthermore, in all prototype classification schemes, the user must be aware of the danger in ‘‘overfitting’’ the training data, that is, when a modeler has undue confidence in the precision of the training data set and is overzealous in finding an algorithm that produces little or no classification error in representing these data. This can impose ‘‘false structure’’ on the mapping, which does not accurately capture the functional dependencies. The danger of overfitting is especially present in neural network modeling because of the tremendous flexibility in the underlying mathematical relationships and results in a sacrifice of generalization (predictive) ability. Vapnik (1995) discusses this issue extensively in the literature of statistical learning theory and information theory. 14.8.4

Classification Results Using a Linear Classifier

Using a linear model and the training data set, a linear regression produced a meansquared error of 0.094. The most important and statistically significant indicators were found to be severity, potency, and magnitude. This implies that these are the metrics that have, in the past, determined whether a contaminant is appropriate for regulatory action. Although prevalence and persistence–mobility are in principle important indicators of human health hazard, the illustrative analysis did not confirm this assumption. Either these factors have not been given significant weight in past regulatory decisionmaking, or the ability to estimate these attribute scores accurately is poor given available data. This finding may change when USEPA constructs a formal training data set, but it illustrates the type of conclusion that can be derived from the use of a classification approach. The next step was the determination of an appropriate threshold value that separates the objects into the two categories, T ¼ 1 (consider regulating), or T ¼ 0 (don’t regulate). Using the determined threshold value, the error in misclassifying T ¼ 1 contaminants was found to be 8% (5 out of 63), and the error in misclassifying T ¼ 0 contaminants was found to be 24% (4 out of 17) (see Table 14.5). The larger error in misclassifying T ¼ 0 contaminants is indicative of the much smaller size of this portion of the training data set, so there is less confidence that the contaminants

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TABLE 14.5 Misclassified Training Data Set Contaminants Using the Linear Classifier Misclassified T ¼ 1 Contaminants o-Dichlorobenzene trans-1,2-Dichloroethylene Toluene HPC Total coliforms

Misclassified T ¼ 0 Contaminants Ethanol Folic acid Olestra Saccharin

Source: Adapted from NRC 2001.

used are representative of the population of contaminants in this category. These errors can be interpreted in terms of the ‘‘sensitivity’’ and ‘‘specificity’’ of the classification results; specifically, the probability of a false negative (sensitivity) is 8% and the probability of a false positive (specificity) is 24%. 14.8.5

Classification Results Using a Neural Network Classifier

Using the same training data set and attribute scores but a neural network architecture, the resulting mean-squared error was 0.018, which is five-fold lower than that achieved using the linear classifier. This result clearly demonstrates the improved fitting capabilities of a neural network model over a linear model. Furthermore, the predicted classification error for the neural network classifier is 3% for false negatives (sensitivity; 2 out of 63). Because there were no misclassifications of the T ¼ 0 contaminants, the false-positive (specificity) rate is estimated to be near zero (see Table 14.6). 14.8.6

Examination of Misclassified Contaminants

Two alternative models for use in the prototype classification scheme—a linear model and a neural network, have been evaluated (NRC 2001). Although the results of both exercises provide compelling support for the potential utility of such an approach in the development of future CCLs, as noted above, the models did not work perfectly. Indeed, although the neural network performed better than the linear model (especially with respect to minimizing the number of misclassified contamiTABLE 14.6 Misclassified Training Data Set Contaminants Using the Neural Network Classifier Misclassified T ¼ 1 Contaminants Ethylbenzene HPC Source: Adapted from NRC 2001.

Misclassified T ¼ 0 Contaminants — —

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nants), it remains unclear which model is most appropriate for USEPA to use, largely because of uncertainties in the training data set employed by the committee. A detailed examination of the misclassification of individual contaminants in the training data in this analysis is available (NRC 2001). These errors can be interpreted in one of three ways. Either (1) the training data ( particularly the attribute scores) do not adequately capture the information that actually determines regulatory action for drinking water contaminants, (2) the model used to relate the input to the output does not adequately capture or simulate the process by which this information is used in regulatory decisionmaking, or (3) the classification variables (target values) are wrong, which would imply that some prior regulatory decisions made in the past are inconsistent with the regulatory decisions regarding the bulk of drinking water contaminants. Assuming that the training data are more or less accurate and complete, then classification errors can be appropriatley reduced by exploring modeling alternatives. In other words, a large number of classification errors resulted from use of a linear model but a neural network model was successfully used to greatly reduce the classification error. While efforts can be taken to try to eliminate all classification errors by using increasingly elaborate neural networks (or other classification models such as support vector machines or radial basis functions), this endeavor may lead to overfitting the data (NRC 2001). 14.8.7

Validation Test Cases

The contaminants listed in the training data set in the ‘‘consider for regulation’’ (T ¼ 1) category did not include all those that currently have drinking water standards. Indeed, four chemicals (arsenic, nitrate, atrazine, tetrachloroethylene) and one microorganism (Giardi lamblia) were deliberately withheld to serve as validation test cases to examine the predictive accuracy of the classification algorithm. Both the linear model and the neural network correctly classified all as properly belonging in the T ¼ 1 category (presumed worthy of regulatory consideration). While these correct predictions are few in number, they provide additional supporting evidence of the validity of the recommended approach. In general, the number of both types of validation test cases should be increased to more thoroughly assess the predictive accuracy of any classification algorithm developed for use in the creation of future CCLs—especially for the contaminants in the ‘‘do not consider for regulation’’ category (T ¼ 0). 14.8.8

Prediction for Interesting Test Cases

To test both the linear and neural network algorithm, five potential organic and inorganic chemical drinking water contaminants (aluminum, aspirin, chloroform, MTBE, and silver) were examined. These contaminants were chosen because data were available and they may be of regulatory interest in the future (NRC 2001). Notably, two of these, aluminum and methyl tert-butyl ether (MTBE), are currently included on the 1998 CCL (see Table 14.2). While the linear classifier predicted that

14.9 VIRULENCE FACTOR–ACTIVITY RELATIONSHIPS (VFARs)

375

all five should be considered for regulatory action (T ¼ 1), the neural network classifier predicted that aspirin, chloroform, MTBE, and silver should be placed on the CCL, but aluminum should not (on the basis of data available at the time when the test was conducted). However, these results are not intended, nor should they be inferred as a recommendation that any of these contaminants be placed on a future CCL or removed from the 1998 CCL—given the limited scope and uncertainties identified by concluding the exercise. Rather, the results are intended to serve as a demonstration of how USEPA can develop and use a prototype classification scheme to help select future PCCL contaminants for inclusion on the CCL.

14.9

VIRULENCE FACTOR–ACTIVITY RELATIONSHIPS (VFARs)

The current approach to identifying and controlling waterborne disease is fundamentally limited in that the identification of pathogens is generally tied to the recognition of an outbreak (NRC 1999a, 2001b). Continuing this practice is not an effective or proactive means for protecting public health, in that current regulatory practice requires that methods to culture microorganisms of interest be developed before occurrence data can be gathered. This longstanding paradigm makes it very difficult to develop a database of potential or emerging waterborne pathogens. It also constitutes a severe bottleneck in identifying and addressing potentially important emerging microbial contaminants in drinking water. Thus, a new approach is needed to help overcome this serious, ongoing problem. A virulence factor activity relationship (VFAR) (see Fig. 14.6) is the known or presumed linkage between the biological characteristics of a microorganism (‘‘descriptors’’) and its real or potential ability to cause harm or other ‘‘outcomes’’ of concern (NRC 2001). The term is rooted in a recognition of the utility of using (quantitative) structure–activity relationships (QSARs or SARs) to compare the structures of new chemicals to those of known chemicals to enable prediction of their toxicity and other physical properties. Research continues to show certain

Figure 14.6 Conceptual illustration of a VFAR predicting outcomes of concern (virulence, potency, persistence) using the presence or quality of descriptor variables [source: adapted from NRC (2001)].

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common characteristics of virulent (i.e., broadly defined as being poisonous or injurious to life) pathogens such as the production of specific toxins, specific surface proteins, and specific repair mechanisms that enhance their ability to infect and cause damage in a host. More recently some of these descriptors have been tied to specific genes, and it has become evident that the same can be done for other descriptors as well. In this regard, the genetic structures of many thousands of organisms [e.g., Vibrio cholerae; see Heidelberg et al. (2000)] have been identified, reported, and stored in what are called gene banks. Increasingly sophisticated computer programs allow for the sorting and matching of genetic structures and specific genes known as bioinformatics, while the study of genes and their function is known as genomics. In addition, a growing area of related interest is functional genomics—understanding the specific role of genes in terms of the function of the organism. The ability to use such tools is needed for the development of VFARs. NRC (2001) concluded that while the technology, methods, and even the genetic databanks exist, the development and implementation of a VFAR approach to assess waterborne pathogens would require considerable effort and expenditure of resources by USEPA in conjunction with the Centers for Disease Control and Prevention, National Institutes of Health, and other federal and state health organizations. Such a joint program would also require extensive expertise in bioinformatics, molecular and environmental microbiology, and infectious diseases. However, opportunities for rapid identification of microbial hazards in water afforded by such a program would greatly improve the ability of USEPA and other agencies to quickly and successfully protect public health and improve water quality.

14.10

NRC RECOMMENDATIONS AND FUTURE DIRECTIONS

In each of its three reports, the NRC made a number of conclusions and recommendations for the future research, monitoring, and regulation of contaminants in the United States. Highlights of many of these recommendations are summarized below, along with observations about future directions and opportunities for the development of a risk-based approach for selecting contaminants for future regulation. USEPA (2002) has announced its preliminary determinations from the 1998 CCL, and final determinations are expected in 2003. For all practical purposes, regulatory attention is now shifting to development of the second (2003) CCL. While USEPA is considering the recommendations of the NRC in this process, given the pressing time constraints, improvements in the CCL process will occur incrementally. Therefore, several iterations of the CCL and regulatory determination process will likely be needed before a robust risk-based process is firmly in place for selecting contaminants for future regulation. USEPA has begun to consider a prototype classification approach. A prototype classification approach must first be trained (calibrated) using a training data set

14.10 NRC RECOMMENDATIONS AND FUTURE DIRECTIONS

377

containing prototype contaminants and can then be used in conjunction with expert judgment to predict whether a future PCCL contaminant should be placed on the corresponding CCL or not (NRC 2001). The deliberate use of the majority of currently regulated drinking water contaminants in the training data set can be described as building on past regulatory decisions to help make future related decisions. However, this approach is necessarily constrained by the data used (i.e., past regulatory decisions). If this is deemed a defensible strategy, then a prototype classification approach to the development of future CCLs can be viewed as valid. Indeed, the most significant (and certainly most innovative) contribution of the three NRC reports is providing the framework and demonstration of how USEPA might develop and apply its own prototype classification scheme for use in the creation of future CCLs. To adopt and implement the recommended prototype classification approach to develop future CCLs, USEPA will necessarily have to employ or work with persons knowledgeable about these methods and to devote appreciable time and resources to construct, update, and maintain a comprehensive training data set. The size of the training data set that was used in their classification demonstration must be greatly increased in order to improve its predictive capacity. Attribute scores for all drinking water contaminants under consideration must be accurately and consistently assigned. To do this, available data for each PCCL contaminant must be collected and organized. In addition, the attribute scoring scheme used must be carefully documented to help ensure a transparent and defensible process. Creating a consolidated database for contaminants under consideration would be of direct benefit to this requirement. Selected contaminants must be withheld from the training data they construct in order to serve as validation test cases to assess the predictive accuracy of whatever classification algorithms they ultimately develop. While the NRC was able to withhold five chemical contaminants presumed worthy of regulatory consideration (T ¼ 1) for this purpose, it had insufficient numbers of contaminants presumed not worthy of regulatory consideration (T ¼ 0) to withhold. While all contaminants withheld for validation were classified correctly as belonging in the T ¼ 1 category and such results provided additional (albeit limited) support for the validity of the classification approach, the number of both types of validation test cases (especially for T ¼ 0 contaminants) must be increased to assess more thoroughly the predictive accuracy of any classification algorithm developed for use to create future CCLs. If neural networks are ultimately used in a prototype classification approach, understanding which contaminant attributes predominantly determine the category of a contaminant will be less transparent than that of a linear model or a more traditional rule-based scheme. However, if the process of mapping attributes into categorical outcomes is very complex, there is little hope that an accurate rule-based classification scheme can be constructed. The fact that the nonlinear neural network performed better than the linear classifier serves as a strong indicator that the underlying mapping process is complex and it will be an exceedingly difficult task for any assemblage of experts to accurately specify the rules and conditions of this mapping.

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Finally, the underlying mapping in a neural network classifier can be examined through numerical experimentation in order to determine the sensitivity of the output to various changes in input data. Although a sensitivity analysis was not conducted by the NRC committee because of time constraints, several training data sets should be used to gauge the sensitivity of the method as part of its analysis and documentation if a classification approach is ultimately adopted and used to help create future CCLs. The VFAR concept is still undergoing development in several areas, including scientific validity and applicability, actual technological feasibility, the application of these technologies to studying disease in humans (validation), the degree to which these methodologies are being universally adopted within the scientific community, and the need for their development and use to adhere to the principles of transparency, public participation, and other sociopolitical considerations (NRC 2001). To one extent or another, each of these elements affects the ability of the VFAR concept to be developed, used, or validated. All of these elements either are present or can reasonably be expected to be available in the near future. Hence, the NRC concluded that the future use of VFARs is indeed feasible. To this end, NRC recommended USEPA establish a scientific VFAR Working Group on bioinformatics, genomics, and proteomics, with an ongoing charge to study these disciplines regularly and periodically inform the agency as to how these disciplines can affect the identification and selection of drinking water contaminants for future regulatory, monitoring, and research activities (NRC 2001). Such a working group should be charged with the task of delineating specific steps and related issues and timelines needed to take VFARs beyond the conceptual framework of the NRC report to actual development and implementation by USEPA. All such efforts should be made in open cooperation with the scientific community, stakeholders, and the public. Finally, full USEPA participation is needed in all ongoing and planned U.S. government efforts in bioinformatics, genomics, and proteomics as potentially related to the identification and selection of waterborne pathogens for regulatory consideration.

ACKNOWLEDGMENTS The authors thank the volunteer expert members of the NRC Committee on Drinking Water Contaminants and the dedicated and professional staff of the USEPA Office of Ground Water and Drinking Water for their collective efforts to help provide and maintain safe drinking water throughout the United States and for making this chapter possible.

REFERENCES Bailey, D., and D. Thompson. 1990. How to develop neural-network application. AI Expert 5(6):38–47.

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Barnes, D. G., and M. Dourson. 1988. Reference dose (RfD): Description and use in health risk assessments. Regul. Toxicol. Pharmacol. 8:471–486. Bowker, G. C., and S. L. Star. 1999. Sorting Things Out: Classification and Its Consequences. Cambridge, MA: Massachusetts Institute of Technology Press. Crump, K. S. 1984. A new method for determining allowable daily intakes. Fund. Appl. Toxicol. 4:854–871. ERG (Eastern Research Group, Inc.)–USEPA. 2000. Endocrine Disruptor Priority-Setting Database. Version 2 Beta. Available online at http:==www.ergweb.com=endocrine=. Garson, G. D. 1998. Neural Networks: An Introductory Guide for Social Scientists. Thousand Oaks, CA: Sage Publications. Gibson, M. C., S. M. deMonsabert, and J. Orme-Zavaleta. 1997. Comparison of noncancer risk assessment approaches for use in deriving drinking water criteria. Regul. Toxicol. Pharmacol. 26:243–256. Heidelberg, J. F., J. A. Elsen, W. C. Nelson, R. A. Clayton, M. L. Gwinn, R. J. Dodson, H. H. Haft, E. K. Hickey, J. D. Peterson, L. Umayam, S. R. Gill, K. E. Nelson, T. D. Read, H. Tettelin, D. Richardson, M. D. Ermolaeva, J. Vamathevan, S. Bass, H. Qin, I. Dragoi, P. Sellers, L. McDonald, T. Utterback, R. D. Fleishmann, W. C. Nierman, O. White, S. L. Salzberg, H. O. Smith, R. R. Colwell, J. J. Mekalanos, J. C. Venter, and C. M. Fraser. 2000. DNA sequence of both chromosomes of the cholera pathogen Vibrio cholerae. Nature 406:477–484. Hinton, G. E. 1992. How neural networks learn from experience. Scientific American, 267:144–151. Hornik, K., M. Stinchombe, and H. White. 1989. Multilayer feedforward networks are universal approximators. Neural Networks 2:359–366. IOM (Institute of Medicine). 1988. Medical Technology Assessment Directory. A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: National Academy Press. IOM. 1992. Setting Priorities for Health Technologies Assessment: A Model Process. Washington, DC: National Academy Press. IOM. 1995. Setting Priorities for Clinical Practice Guidelines. Washington, DC: National Academy Press. Keller, P. E., S. Hashem, L. J. Kangas, and R. T. Kouzes. 1995. Applications of Neural Networks in Environment, Energy, and Health. Proc. 1995 Workshop on Environmental and Energy Applications of Neural Networks. River Edge, NJ: World Scientific. NRC. 1977. Drinking Water and Health, Vol. 1. Washington, DC: National Academy Press. NRC. 1988. Enhancing Human Performance: Issues, Theories, and Techniques. Washington, DC: National Academy Press. NRC. 1992. In the Mind’s Eye: Enhancing Human Performance. Washington, DC: National Academy Press. NRC. 1999a. Setting Priorities for Drinking Water Contaminants. Washington, DC: National Academy Press. NRC. 1999b. Identifying Future Drinking Water Contaminants. Washington, DC: National Academy Press. NRC. 2001. Classifying Drinking Water Contaminants for Regulatory Consideration. Washington, DC: National Academy Press.

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Swanson, M. B. and A. C. Socha, eds. 1997. Chemical ranking and scoring: Guidelines for relative assessments of chemicals. Proc. Pellston Workshop on Chemical Ranking and Scoring. Pensacola, FL: Society of Environmental Toxicology and Chemistry Press. USEPA. 1997a. Announcement of the Draft Drinking Water Contaminant Candidate List; Notice. Fed. Reg. 62:52194–52219. USEPA. 1997b. Meeting Summary: EPA National Drinking Water Contaminant Occurrence Data Base. Contract. 68-W4-0001 prepared for Office of Ground Water and Drinking Water. Washington, DC: RESOLVE, Inc. USEPA. 1998a. Announcement of the Drinking Water Contaminant Candidate List; Notice. Fed. Reg. 63:10274–10287. USEPA. 1998b. USEPA Response to Comment Document: Draft Drinking Water Contaminant Candidate List. Washington, DC: Office of Ground Water and Drinking Water. USEPA. 1999a. Final Revisions to the Unregulated Contaminant Monitoring Regulation; Fact Sheet. Washington, DC: Office of Ground Water and Drinking Water. USEPA. 1999b. Issue Papers for Stakeholder Meeting of November 16, 1999. Washington, DC: Office of Ground Water and Drinking Water. USEPA. 1999c. National Drinking Water Advisory Council Fact Sheet. EPA 816-F-99-009. Washington, DC: Office of Ground Water and Drinking Water (http:==www.epa. gov=safewater=ndwac=council.html). USEPA. 1999d. Revisions to the Unregulated Contaminant Monitoring Regulation for Public Water Systems; Final Rule. Fed. Reg. 64(180):50556–50620. USEPA. 1999e. Revisions to the Unregulated Contaminant Monitoring Regulation for Public Water Systems: Proposed Rule. Fed. Reg. 64(83):23397–23458. USEPA. 2000a. Draft Research Plan for the Drinking Water Contaminant Candidate List. Washington, DC: Science Advisory Board Review Draft. USEPA. 2000b. National Drinking Water Contaminant Occurrence Database: Introduction. Available online at http:==www.epa.gov=ncod. USEPA. 2000c. National Drinking Water Contaminant User’s Guide Release Two. Available online at: http:==www.epa.gov=ncod=html=ncod_userguide.html. USEPA. 2002. Announcement of Preliminary Regulatory Determinations for Priority Contaminants on the Drinking Water Contaminant Candidate List. Notice of Preliminary Regulatory Determination. Fed. Reg. 67:38222–38244. Vapnik, V. N. 1995. The Nature of Statistical Learning Theory. New York: Springer-Verlag. Webler, T., D. Levine, H. Rakel, and O. Renn. 1991. A novel approach to reducing uncertainty: The group Delphi. Technological Forecasting and Social Change, 39:253–263. Weiss, S. M. and C. A. Kulikowski. 1990. Computer Systems that Learn: Classification and Prediction Methods from Statistics, Neural Nets, Machine Learning, and Expert Systems. San Mateo, CA: Morgan Kaufmann. Zupan, J. and J. Gasteiger. 1993. Neural Networks for Chemists: An Introduction. New York: VCH.

15 SELECTION OF TREATMENT TECHNOLOGY FOR SDWA COMPLIANCE FREDERICK W. PONTIUS, P.E. Pontius Water Consultants, Inc., Lakewood, Colorado

15.1

INTRODUCTION

Historically, water utility selection of water treatment technologies has been driven by three primary factors: the contaminants of immediate concern, new water quality regulations, and the need to minimize costs. From the early 1900s to about 1975, conventional treatment—chemical clarification, granular media filtration, and chlorination—were virtually the only treatment processes used for municipal water treatment in the United States (see Chapter 1). Since the 1980s, a shift in the water industry’s approach to water treatment has occurred. Now, water utilities seriously consider and frequently select newer treatment technologies over or in addition to traditional conventional treatment. This chapter discusses the general impact of Safe Drinking Water Act (SDWA) on selection of water treatment technologies for compliance.

15.2 SDWA REQUIREMENTS AFFECTING TECHNOLOGY SELECTION The SDWA provides specific guidance and requirements concerning treatment technology that the U.S. Environmental Protection Agency (USEPA) must consider when setting National Primary Drinking Water Regulations (NPDWRs). SDWA requirements also influence water utility selection of treatment technologies for regulatory compliance. Drinking Water Regulation and Health, Edited by Frederick W. Pontius. ISBN 0-471-41554-5 # 2003 John Wiley & Sons, Inc.

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SELECTION OF TREATMENT TECHNOLOGY FOR SDWA COMPLIANCE

Best Available Technology (BAT)

The 1986 SDWA Amendments specified a process for setting maximum contaminant levels (MCLs) as close to the maximum contaminant level goal (MCLG) as is ‘‘feasible.’’ The SDWA states that ‘‘the term ‘feasible’ means feasible with the use of the best technology, treatment techniques and other means which the Administrator finds, after examination for efficacy under field conditions and not solely under laboratory conditions, are available (taking cost into consideration)’’ [Sec. 1412(b)(4)(D)]. Technologies that meet this feasibility criterion are called ‘‘best available technologies’’ (BATs) and are listed in each proposed and final NPDWR. The 1986 SDWA process for specifying BAT was retained in the amended 1996 SDWA. In general, a water utility may use any treatment technology acceptable to their State Primacy Agency to comply with NPDWRs. The technology selected may or may not be designated as BAT by USEPA. But a water utility seeking a variance must agree to install a BAT. NPDWRs may set an MCL requirement or a treatment technique requirement. Should an MCL be set, a water utility must select technologies that will result in compliance with all applicable MCLs that the system is or may be required to meet. For example, a water system considering technology to meet the new arsenic MCL must also consider other regulated and potentially regulated contaminants that would affect the water system. Not all regulated contaminants may be present in a specific source water, and therefore may not be of concern to a particular water system. Water systems must carefully characterize their source water quality, both existing and future, when making treatment technology choices. In addition, the potential for deliberate contamination must also be considered (Pontius 2002), as discussed in Chapter 24. Section 1412(b)(7)(A) of the 1986 SDWA listed the conditions under which a treatment technique (TT) could be promulgated in lieu of an MCL. When these conditions are met, the Act states that ‘‘the Administrator must identify those treatment techniques which, in the Administrator’s judgment, would prevent known or anticipated adverse effects on the health of persons to the extent feasible.’’ For example, the Surface Water Treatment Rule (SWTR), promulgated in 1989, requires compliance with a TT rather than an MCL. The TCR, also promulgated in 1989, requires compliance with an MCL and specifies treatments and other means for water system compliance. Prior to the 1996 SDWA Amendments, cost assessments for treatment technology feasibility determinations were based on impacts to regional and large metropolitan water systems. This protocol was established when the SDWA was originally enacted in 1974 (Congress 1974) and was retained when the SDWA was amended in 1986 (Congress 1986). The service population size categories USEPA has used to make feasibility determinations for regional and large metropolitan water systems differs between NPDWRs. The technical demands and costs associated with technologies feasible for regional and large metropolitan water systems usually render the technologies inappropriate for small systems.

15.2 SDWA REQUIREMENTS AFFECTING TECHNOLOGY SELECTION

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The 1996 SDWA Amendments specifically requires USEPA to make technology assessments for three categories of small systems for both existing regulations (e.g., SWTR and TCR) and future requirements. The three population-based size categories of small systems defined are 10,000–3301 persons, 3300–501 persons, and 500–25 persons. 15.2.2

Compliance and Variance Technologies

The 1996 SDWA Amendments identify two classes of technologies for small systems: compliance technologies and variance technologies. A ‘‘compliance technology’’ may refer to both (1) a technology or other means that is affordable and that achieves compliance with the MCL and (2) a technology or other means that satisfies a treatment technique requirement. Possible compliance technologies include packaged or modular systems and point-of-use (POU) or point-of-entry (POE) treatment units. (See Chapter 16 for further discussion of POU and POE treatment.) Variance technologies are only specified for those system size–source water quality combinations for which no compliance technologies are listed. Therefore, the listing of a compliance technology for a size category–source water combination prohibits the listing of variance technologies for that combination. While variance technologies may not achieve compliance with the MCL or TT requirement, they must achieve the maximum reduction or inactivation efficiency that is affordable considering the size of the system and the quality of the source water. Variance technologies must also achieve a level of contaminant reduction that is protective of public health. The variance procedure for small systems was significantly revised in 1996. Under the 1986 SDWA Amendments systems were required to install a technology before applying for a variance; if they were unable to meet the MCL, they could then apply for a variance. The 1996 Amendments have given the variance option flexibility in that variances can be applied for and granted before the variance technology is installed, thereby ensuring that the system will have a variance before it invests in treatment. Under the 1996 Amendments there is a new procedure available for small systems (systems serving fewer than 10,000): the ‘‘small system variance.’’ The difference between a regular variance and a small system variance is the basis for the feasibility (technical and affordability) determination. For the former, large systems are the basis; for the latter, small systems are the basis. If there are no affordable compliance technologies listed by the USEPA for a small system size category–source water quality combination, then the system may apply for a small system variance. One criterion for obtaining a small system variance is that the system install a variance technology listed for that size category–source water quality combination. A small system variance may only be obtained if alternate source, treatment, and restructuring options are unaffordable at the system-level. Several SDWA requirements affect the listing of variance technologies:
Small system variances are not available for any MCL or treatment technique for a contaminant with respect to which a national primary drinking water regulation was promulgated prior to January 1, 1986 [Sec. 1415(e)(6)(A)].

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Small system variances are not available for regulations addressing microbiological contamination (including contamination by bacteria, viruses, or other organisms) or any indicator or treatment technique for a microbial contaminant [Sec. 1415(e)(6)(B)]. Therefore, there are no variances or variance technologies available for the SWTR and TCR. In addition, because the SWTR and TCR address microbial contamination, the affordability criteria do not apply. 15.2.3

Compliance Technology Lists

The SDWA requires USEPA to issue certain compliance technology lists, but does not specify the content of such lists. In general, USEPA lists provide detail on the capabilities, applicability ranges, water quality concerns, and operational and maintenance requirements for the identified compliance technologies (USEPA 1998a, 1998b). Technologies that are less familiar, known as ‘‘emerging’’ technologies, are also included in the listings, and are given greater coverage. ‘‘Emerging technologies’’ are those technologies that indicate a likelihood of success in meeting the specific treatment goals but that require further evaluation. USEPA listings are updated as required. To date (2003), the agency has issued the following technology lists:
Small System Compliance Technology List for the Surface Water Treatment Rule and Total Coliform Rule, EPA 815-R-98-001 (Sept. 1998).
Small System Compliance Technology List for the Non-Microbial Contaminants Regulated before 1996, EPA 815-R-98-002 (Sept. 1998). The lists are not product-specific because (1) USEPA does not have the resources to review each product for each potential application and (2) specific product review is beyond USEPA’s purview. Information on specific products is available through the USEPA’s Office of Research and Development and NSF International a pilot project under the Environmental Technology Verification (ETV) program. The ETV program is designed to provide treatment purchasers with performance data from independent third-party organizations. The USEPA=NSF are cooperatively conducting this project to provide the mechanism for ‘‘verification testing’’ of packaged drinking water treatment systems. The ETV program includes development of verification protocols and test plans, independent testing and validation of packaged equipment, partnerships among test=verification entities to obtain credible cost and performance data, and preparation of product verification reports for widespread distribution. For more information, go to the NSF-ETV Website: http:== www.nsf.org=verification=verification.html. 15.2.4

Variance Technology Determinations

Compliance technologies and variance technologies are mutually exclusive. Variance technologies are specified only for those system–source water quality combinations

15.3 ACCEPTANCE OF NEW TECHNOLOGY

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for which there are no listed compliance technologies. Therefore, the listing of a compliance technology for a size category–source water combination prohibits the listing of variance technologies for that combination. USEPA (1998c) assessed the compliance and variance technologies for contaminants regulated before 1996 considering SDWA restrictions, public health protection, and affordability. The two compliance technology lists mentioned above (USEPA 1998a, 1998b) for contaminants regulated before 1996 identified compliance technologies for all of the 80 regulated contaminants, including affordable compliance technologies for all classes of small water systems. Therefore, USEPA decided not to list variance technologies for any existing NPDWR. In addition, NPDWRs issued to date (2003) have determined that affordable compliance technologies are available for small systems; therefore, no small system variances are allowed. In certain cases, water systems may still quality for a general variance (SDWA Sec. 1415) or an exemption (SDWA Sec. 1416).

15.3

ACCEPTANCE OF NEW TECHNOLOGY

In addition to SDWA requirements, other factors must be considered when selecting water treatment technology. Older tried-and-true technologies are often favored over newer emerging technologies because water utility decisionmakers and state regulators cannot afford the consequences associated with technology failures, in terms of both the dollar cost and political fallout. Although newer technologies may have certain performance advantages over older technologies, they may not be readily accepted by state regulators, who typically review and approve plans and specifications for specific projects. In addition, not all technologies that might be considered and selected will meet USEPA criteria for BAT. For example, the granular ferric hydroxide (GFH) adsorptive medium is very effective for arsenic removal, and is listed in the USEPA arsenic rule as a compliance technology, but it is not designated as BAT. In a free marketplace, a new technology must have one or more advantages over other traditional treatment processes to even be considered. Advantages could include a lower capital cost, lower operation and maintenance (O&M) costs, higher efficiency, easier operation, improved treated water quality, or less waste production. Najm and Trussell (1999) describe the typical steps for a new technology to be introduced into the marketplace. To be successfully introduced into the U.S. marketplace, the technology must usually be demonstrated effective. Typical steps involved in this process are 1. Demonstration of the technology in another field, country, or area 2. Bench- and pilot-scale [1–50-gpm (gallons per minute)] studies to document performance under differing water quality conditions 3. Verification of treatment process effectiveness at demonstration-scale level (>100 gpm)

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4. Multiple successful installation, operation, and performance at a small full-scale level [0.5 to 5 mgd (million gallons per day)] 5. Installation and operation at a large-scale municipal water treatment plant In addition, a new technology must be approved by the appropriate regulatory agencies, and be optimized so that costs of the technology are competitive. Regulatory approval is typically needed by the end of the demonstration-scale verification step and prior to installation at small full-scale plants. Requirements of applicable voluntary consensus standards developed by the American Water Works Association (AWWA) and the American National Standards Institute (ANSI) must typically be met as well. Ultimately, to be fully accepted, the cost of the newer technology must be competitive with that of other more accepted processes achieving the same water quality objective(s). The time necessary for each of the five stages listed above can vary greatly. Factors include the technology considered, urgency to have it implemented, how long before costs reach competitive levels, and the significance of its role within the overall water treatment train. Technologies essential to a water treatment process train may be approved in less (or more) time than a technology proposed to replace a less important component. A wide range of water treatment technologies have already been developed or are currently in development. Technologies that can be applied in municipal water treatment plants should meet the following criteria (Najm and Trussell 1999):
The technology can be scaled to large applications (i.e., >5 mgd).
The technology can be cost-competitive with existing technologies, at large scale.
The technology can produce water that meets the regulatory requirements.
The technology has a high degree of reliability.

15.4

ADVANCED TREATMENT TECHNOLOGY OVERVIEW

Water utilities have a wide selection of treatment technologies from which to choose, and options continue to increase. At any given time, a variety of technologies will be in various stages of introduction, use in the United States, and consideration by USEPA as BAT. Many water systems will consider advanced treatment technologies to meet anticipated regulations. In some cases, advanced technologies are not new to the water industry, but their application has been limited, or questions have remained regarding large-scale application. Advanced technologies that are receiving increased attention are discussed below, but this discussion is not exhaustive. Refer to Najm and Trussell (1999) for additional detailed discussion of emerging technologies. Logsdon et al. (1999) review the selection of water treatment process in general, including several emerging technologies.

15.4 ADVANCED TREATMENT TECHNOLOGY OVERVIEW

15.4.1

387

Membranes

Applications of membrane systems have been increasing in the U.S. water industry since the mid-1990s. They are generally classified into three general types of systems (AWWA Research Foundation=Lyonnaise des Eaux=Water Research Commission of South Africa 1996): 1. Low-pressure membrane systems (microfiltration and ultrafiltration) 2. High-pressure membrane systems (nanofiltration and reverse osmosis) 3. Integrated membrane systems (combinations of 1 and 2) Low-pressure membranes include microfiltration (MF) and ultrafiltration (UF), and operate at pressures ranging from 10 to 30 psi (lb=in.2). High-pressure membranes include nanofiltration (NF) and reverse osmosis (RO) and operate at pressures ranging from 75 to 250 psi. Membrane pore size compared to the size of common water contaminants is shown in Figure 15.1. Membrane treatment has rapidly become accepted by many regulatory agencies (USEPA 2001a). Low-pressure membrane filtration (MF and UF) is replacing conventional filtration for surface-water treatment at many locations in the United States. High-pressure membranes (both NF and RO) are used primarily for softening and TDS reduction. RO is used for nitrate reduction and both NF and RO are effective for removing natural organic matter (NOM). The principal barrier to large-scale implementation of membranes has been its capital cost. But ongoing

Figure 15.1 Pore size ranges of various membranes.

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development of large-scale membrane systems have lowered their capital cost to be competitive with conventional treatment processes.

Low-Pressure Membranes Low-pressure membrane filtration was applied for surface water treatment beginning in the early 1980s. At the time, low-pressure membranes had long been used in the food-processing industry as nonchemical disinfectants. MF membranes (with a nominal pore size of 0.2 mm) and UF membranes (with a nominal pore size of 0.01 mm) are highly capable of removing particulate matter (turbidity) and microorganisms. For these contaminants, membrane-treated water is superior to that produced by conventional filtration plants. Both MF and UF function as an ‘‘absolute barrier’’ to Giardia cysts and Cryptosporidium oocysts when membrane fibers and fittings are intact. Jacangelo et al. (1995) found UF to act as absolute barriers to viruses due to their nominal pore size of 0.01 mm. Low-pressure membranes have several advantages over conventional filtration and chlorination for surface water treatment. These include smaller waste stream, lower chemical usage, smaller footprint, greater pathogen reduction, no disinfection byproduct formation, and automation (less operator attention). Low-pressure membranes can treat turbidity excursions as high as several hundreds of NTUs with manageable impacts on process operation and efficiency (Yoo et al. 1995). Like all technologies, low-pressure membranes have certain disadvantages. Because of their large pore size, they are generally ineffective for removing dissolved organic matter. Color-causing organic matter, taste-and-odor-causing compounds, and anthropogenic chemicals can pass through the membranes into the treated water. Introducing powdered activated carbon (PAC) or other adsorbent media into the system for subsequent removal by the membrane can improve removal of dissolved contaminants. PAC injected into the influent water to the membrane is rejected by the membrane and disposed of with the wastestream. Since the early 1990s, the cost of low-pressure membranes has decreased dramatically, making it more attractive to water utilities for full-scale implementation. Today, membrane filtration is widely accepted as a reliable water treatment technology (USEPA 2001a). Membrane plants being planned in the United States range in capacity from 30 to as high as 60 MGD.

High-Pressure Membranes High-pressure membranes include both NF and RO membranes. NF membranes are thin-film composite (TFC) RO membranes developed specifically to cover the pore size between RO membranes (<1 nm) and UF membranes (>2 nm) (Matsuura 1993); hence the term ‘‘nanofiltration.’’ The result was a type of membrane that operates at higher flux and lower pressure than traditional cellulose acetate (CA) RO membranes. NF membranes are sometimes referred to as ‘‘loose’’ RO membranes. They are typically used when high sodium rejection is not required, but divalent ions (such as calcium and magnesium) are to be removed (Scott 1995).

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NF membrane systems commonly operate at pressures ranging from 75 to 150 psi (Lozier et al. 1997). NF membranes have been used successfully for groundwater softening since they achieve greater than 90% rejection of divalent ions such as calcium and magnesium (Conlon and McClellan 1989, Bergman 1996, Scott 1995). Commercially available NF membranes have molecular weight cutoff values ranging from 200 to 500 Da (daltons) (Bergman 1992, Scott 1995). Consequently, they are capable of removing greater than 90% of natural organic matter present in the water (Najm and Trussell 1999), and are good for the removal of color and DBP precursor material (Tan and Amy 1989, Chellam et al. 1997). RO membranes have long been used for the desalination of seawater. These membranes can consistently remove about 99% of the total dissolved solids (TDS) present in the water, including monovalent ions such as chloride, bromide, and sodium. However, for a long time these membranes were made predominantly from cellulose acetate (CA) and required operating pressures of 250 psi. More recent innovations in RO membrane manufacturing have resulted in TFC RO membranes that can achieve higher rejection of inorganic and organic contaminants than CA RO membranes, while operating at substantially lower pressures (100– 150 psi) (Najm and Trussell 1999). In addition, CA RO membranes commonly require acid addition to lower the pH of the water to a range of 5.5–6.0 to avoid hydrolysis of the membrane material. TFC RO membranes do not hydrolyze at neutral or high pH, and therefore do not require pH depression with acid addition. However, pH depression for preventing the precipitation of salts on the membrane surface (such as CaCO3) may still be necessary in some cases depending on the quality of the water being treated, and the availability of suitable antiscalents. The main obstacle to increased application of high-pressure membranes in municipal water treatment is their high cost, but this technology is currently accepted by regulatory agencies. Integrated Membrane Systems The combination of two membrane systems in series (MF or UF followed by NF or RO) provides a treatment process train capable of removing the vast majority of dissolved and suspended material present in water. This treatment train is commonly termed an ‘‘integrated membrane system,’’ ‘‘two-stage membrane filtration,’’ or ‘‘dual-stage membrane filtration.’’ Only lowmolecular-weight organic chemicals are thought to pass through such a system. Compared to conventional treatment, a two-stage membrane filtration process (possibly coupled with PAC addition) would produce superior water quality. But such highly treated water quality may be more corrosive. Integrated membrane systems have been successfully applied for surface water treatment (Wiesner et al. 1994, Vickers et al. 1997, Kruithof et al. 1997, Chellam et al. 1997). The combined particulate removal and organic removal capabilities of this treatment approach produces excellent water quality that complies with existing and anticipated regulatory requirements (Najm and Trussell 1999). Lozier et al. (1997) estimated the capital cost of a 40-gpm, two-membrane system at approximately $4=gpd. The capital unit cost of a large-scale, two-stage membrane system may range from $2=gpd to $3=gpd of capacity. This is still substantially

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higher than the cost of conventional treatment, which is estimated between $1=gpd and $1.5=gpd. 15.4.2

Ultraviolet (UV) Disinfection

Ultraviolet (UV) irradiation technology is used for water treatment as a disinfection process that capitalizes on the germicidal effect of UV light in the wavelength range of 250–270 nm (USEPA 1996). The process is typically designed so that water flows through a chamber around a series of UV lamps. Microorganisms in the water are inactivated through exposure to UV light. UV energy disrupts the DNA of the microorganisms and prevents it from reproducing. The UV disinfection process is compact because the time of exposure required is typically very short, measured in seconds. UV disinfection has been used since the 1950s at approximately 500 drinking water facilities in the United States, and more than 1500 facilities in Europe (Parrotta and Bekdash 1998, Kruithof et al. 1992). Until the late 1990s, the vast majority of the U.S. facilities were either transient–noncommunity groundwater systems or nontransient–noncommunity groundwater systems serving less than 3000 people each. These facilities provide water to restaurants, highway rest areas, airports, schools, camps, factories, rest homes, and hospitals. For many years, UV disinfection for drinking water treatment was only promoted for small groundwater systems. The process has recently been scaled up successfully to larger drinking water applications. For water treatment systems, a minimum UV dose is commonly set for UV systems. The NSF standard for Class A UV systems (i.e., those that can be used as POU and POE treatment devices) requires that they emit a minimum UV dose of 38 (mWs)=cm2, which is the dose determined to inactivate Bacillus subtilis spores (ANSI=NSF 1991). Several states, including New Jersey and Wisconsin, have specific criteria for UV systems in the form of a minimum dose (Parrotta and Bekdash 1998). Several European countries have also adopted minimum UV doses for pretreated drinking water [Norway at 16 (mWs)=cm2 and Austria at 30 (mWs)=cm2], based on inactivation of bacteria and viruses, but not protozoans (Najm and Trussell 1999). Prior to 1998, UV was generally thought to be ineffective against protozoan cysts such as Cryptosporidium. Research by Bolton et al. (1998) began to change this perception. Cryptosporidium oocysts are inactivated by medium pressure UV (i.e., broadband emission) with efficiencies similar to that observed with E. coli, achieving 4log inactivation with fluences (UV doses) of 10–20 mJ=cm2. Subsequent research has demonstrated that low-pressure UV (i.e., monochromatic emission; 254 nm) is equally effective for Cryptosporidium inactivation. UV disinfection is demonstrated effective for inactivating Giardia cysts and other microorganisms. Karanis et al. (1992) conducted a laboratory study in distilled water to evaluate the UV inactivation of Giardia lamblia cysts obtained from infected humans and from gerbils. A UV dose of approximately 40 (mWs)=cm2 achieved 0.5log inactivation of Giardia lamblia, whereas a UV dose of 180 (mWs)=cm2 was

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required to achieve 2log inactivation of Giardia cysts. Rice and Hoff (1981) also showed that a UV dose of 63 (mWs)=cm2 achieved 0.5log inactivation of Giardia cysts, also in distilled water. Campbell and Wallis (2002) studied the effect of UV irradiation on human-derived Giardia lamblia cysts using a 254-nm collimated beam. Up to 2log (99%) inactivation was observed at a UV dose of approximately 10 mJ=cm2. Higher UV doses (between 20 and 40 mJ=cm2 resulted in up to 3log (99.9%) inactivation of cysts. Mofidi et al. (2002) studied the germicidal effect of a low-pressure UV lamp on Giardia lamblia and Giardia muris cysts. Controlled benchscale, collimated-beam tests exposed cysts suspended in filtered natural water to UV light. Both G. lamblia and G. muris cysts showed similar sensitivity to UV light. At 3 mJ=cm2, >2log (99%) inactivation was observed. Linden et al. (2002) examined inactivation of G. lamblia cysts in buffered saline water by near-monochromatic (254 nm) UV irradiation from low-pressure lamps using a collimated beam. Reduction of G. lamblia infectivity for gerbils was very rapid and extensive, reaching >4log (99.99%) reduction within a dose of 10 J=M2. They report no evidence of DNA repair leading to infectivity reactivation at practical UV disinfection doses. Huffman et al. (2002) examined the ability of UV light to inactivate microsporidia Encephalitozoon intestinalis spores. Lowand medium-pressure UV light achieved >3.6log removal at a dose of 6 mJ=cm2. Four types of UV technology are applicable for drinking water treatment:





Low-pressure, low-intensity (LP-LI) UV technology Low-pressure, medium-intensity (LP-MI) UV technology Medium-pressure, high-intensity (MP-HI) UV technology Pulsed-UV (PUV) technology

Najm and Trussell (1999) review the advantages and disadvantages of these UV technologies in some detail. Approximately 90% of the UV installations in North America are LP-LI UV technology, with some systems dating back to the 1970s. In 1997, USEPA published a draft guidance document for the application of UV technology (USEPA 1997). More recently, USEPA released a second draft guidance document for UV as part of development of the Long Term 2 Enhanced Surface Water Treatment Rule (LT2ESWTR) (USEPA 2001b). Final USEPA guidance is not expected until 2004 or later. The California DHS has set a specific dose of 140 (mWs)=cm2 as a requirement to meet the Title 22 criteria of 2.2 coliforms= 100 mL in reclaimed water.

15.4.3

Advanced Oxidation

Advanced oxidation processes (AOPs) produce hydroxyl radicals (OH
) for the oxidation of organic and inorganic water impurities (Glaze et al. 1987, Aieta et al. 1988). AOPs potentially have multiple uses in water treatment, including oxidation of synthetic organic chemicals (SOCs), color, taste-and-odor causing compounds,

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sulfide, iron, and manganese, and destruction of DBP precursors prior to the addition of chlorine (Najm and Trussell 1999, Trussell and Najm 1999). Several process qualify as AOPs, but only ozone is currently (2003) being applied for municipal water treatment on a large scale. Ozone with hydrogen peroxide has been found effective for certain applications. Ozone AWWARF and CGE (1991) review the fundamental chemical principles of ozone reactions in water to produce hydroxyl radicals, general ozone applications in water treatment, and the design of ozone treatment systems. Ozone is no longer considered an ‘‘emerging’’ water treatment technology. Several large municipal treatment plants apply ozone, including the City of Los Angeles’ 600-mgd Aqueduct Filtration Plant (12,000 lb=day ozone capacity) and the City of Dallas’ 300-mgd Elm-Fork water treatment plant (15,000 lb=day ozone capacity). With increased pressure to reduce chlorination byproduct formation, and the need to inactivate increasingly resistant pathogens, many utilities are applying ozone as their primary disinfection process. Ozone also has unique benefits over most other disinfectants including taste and odor control and the ability to inactivate Cryptosporidium. Clark et al. (2002) has proposed a CT equation for ozone inactivation of Cryptosporidium. Ozone disinfection system design is very sensitive to the target organism selected. To achieve low levels of Giardia inactivation, an average hydraulic retention time of 8–12 min, and ozone doses ranging from 0.5 to 2 mg=L are needed for an average water quality. For such low doses, the ozone residual concentration is virtually nondetectable in the effluent of the ozone contactor. Cryptosporidium inactivation requires a far higher CT requirement, which translates into higher ozone doses and=or longer contact times. In addition, doses required for Cryptosporidium inactivation result in substantially high ozone residual levels in the effluent water from a conventionally designed contactor. Therefore, quenching of this residual ozone before the water exits the contactor is necessary to minimize operator exposure to unhealthy levels of ozone in the atmosphere. An obstacle to wider use of ozonation for drinking water treatment is the potential formation of bromate (BrO3). Bromate is a probable human carcinogen (USEPA Group B2), and forms when ozone treated water contains bromide. In general, bromide concentrations greater than 50 mg=L may result in bromate formation at levels greater than the MCL of 10 mg=L. At this time (2003), the only demonstrated bromate formation control strategy is to depress the water pH in the ozone contactor to less than 6.5–7. Rule-of-thumb costs for ozone generation systems are estimated at $2000–$3000 per pound per day of ozone capacity (Najm and Trussell 1999). A 12-mgd treatment plant requiring an ozone dose of 5 mg=L would have a capital cost for the ozone treatment system of an estimated $1M–$1.5M ($1,000,000–$1,500,000). This includes the ozone equipment, and the concrete ozone contactor. This cost range is equivalent to a unit capital cost of $0.08=gpd to $0.12=gpd of capacity. Ozone with Hydrogen Peroxide Addition When hydrogen peroxide (H2O2) is added to ozonated water, it reacts with molecular ozone, accelerating the formation

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of hydroxyl radicals. Therefore, in an ozone–H2O2 process, the goal is to increase the concentration of hydroxyl radicals, which is a stronger oxidizer than molecular ozone, and consequently rapidly reduce the concentration of molecular ozone. Therefore, hydrogen peroxide is added to an ozone process if it is used as an oxidation process, but not as a disinfection process that relies on the prevalence of a high concentration of molecular ozone. The ozone–H2O2 process is an emerging technology that may be used for the destruction of taste- and odor-causing compounds, color removal, and the destruction of micropollutants, such as VOCs (Karimi et al. 1997), pesticides, and herbicides.

15.4.4

Ion-Exchange and Inorganic Adsorptive Media

Ion exchange (IX) has been used for water treatment for many years, mostly limited to water softening (Ca2þ and Mg2þ removal). New regulatory limits being set for several inorganic chemicals is creating new interest in IX technology for water treatment. Primary candidates for removal with IX include nitrate, arsenic, selenium, barium, radium, lead, fluoride, and chromate. A new contaminant discovered in groundwaters is perchlorate (ClO4), a component of solid-rocket fuel (Pontius et al. 2000). The California Department of Health Services has adopted a perchlorate action level of 18 mg=L. Ion-exchange technology is ideal for the removal of perchlorate ion from contaminated groundwater (Tripp and Clifford 2000). The technology is commonly designed as a fixed-bed process in which a synthetic resin is packed. As water passes through the resin bed, contaminant ions present in the water are exchanged with ions on the resin surface or adsorbed onto the resin surface, thus removing the contaminant ions from the water and concentrating them on the resin. The resin is frequently regenerated to remove the contaminant from the resin surface and replenish the resin with the original exchange ion. There are four primary types of IX resins:





Strong-acid cationic (SAC) resin Weak-acid cationic (WAC) resin Strong-base anionic (SBA) resin Weak-base anionic (WBA) resin

Clifford (1990) discusses the various ions that can be removed by each type of IX resin, the resin-regeneration requirements, and some of the operating pH ranges for each resin type. As their names indicate, SAC and WAC resins are used to remove cations from water (e.g., Ca2þ, Mg2þ, Ra2þ, Ba2þ, Pb2þ), while SBA and WBA resins are used to remove anions from water (e.g., NO3, SO42, ClO4, HAsO42, SeO32). SAC resins operate over a wide range of pH values (1–14), whereas WAC resins can operate only at pH > 7. During water softening, SAC resins can remove both carbonate and noncarbonate hardness, whereas WAC resins can remove only carbonate hardness. On the other hand, WAC resins are easier to regenerate than SAC resins and do not result in sodium concentration increase as SAC resins do.

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Adsorbent media processes for removal of inorganic contaminants are operated in much the same way as IX systems. Adsorbent media for inorganic adsorption include activated alumina and GFH, which are effective for removal of arsenic from drinking waters. The primary obstacle to application of IX and adsorbent media on large scale is the wastestream produced by these processes. The volume of the wastestream may not be large. For example, the wastestream for IX can amount to only 2–5% of the water volume treated. But the wastestream does contain a high concentration of acid (HCl), base (NaOH), or salt (NaCl), ranging from 1 to 3  106 M. In addition, the wastestream contains a high concentration of the contaminant removed from the water (NO3, HAsO4, Pb2þ, etc.). Plants in coastal areas may have the option of disposing of this stream into the ocean. In some cases, small systems are being designed where the adsorbent medium is being used only once and then replaced, without regeneration. Although higher in cost overall compared to regenerated systems, operation of such one-time-use media processes is simpler for small systems, and disposal of spent solid media is usually easier than a concentrated regenerant brine.

15.4.5

Biological Filtration

Historically, the U.S. water treatment industry has depended solely on physical and=or chemical processes to meet water quality goals. Use of biological processes in water treatment has been discouraged by state regulators because of concern about the introduction of microorganisms to water. This attitude is slowly changing with the introduction of biological filtration as the most effective process for the production of biologically stable water. Biodegradable organic matter (BOM) resulting from ozonation of natural waters may have increased potential for biological regrowth in the distribution system. Biological filtration within the water treatment plant after ozonation lowers BOM concentrations before water passes into the distribution system. Biological filtration is an emerging technology. Pilot studies conducted by various researchers (Emelko et al. 1997, Coffey et al. 1997) have found that either GAC or anthracite, compared to sand, is needed as the attachment media for the biofilm. Wang et al. (1995) showed that the concentration of biomass on the surface of biologically active GAC filters was approximately 3–8 times greater than that on the surface of biologically active anthracite filters. The general trend in biological filter design is to include a shallow sand layer (6–12 in.) under the GAC or anthracite media (Najm and Trussell 1999). This sand layer serves as a partial barrier against the breakthrough of biomass into the filter– effluent water. Biological filters are operated the same as conventional dual-medium filters, with the exception that no chlorine or chloramine is present in the influent water to the filter. Biofiltration can be effective for the biological reduction of inorganic contaminants such as nitrate, bromate, perchlorate, chlorate, and selenate. But additional work is needed to address operational issues and optimize the

15.5 SIMULTANEOUS COMPLIANCE

395

biofiltration process before it is widely implemented in U.S. water treatment practice (Najm and Trussell 1999).

15.5

SIMULTANEOUS COMPLIANCE

Water utilities typically face achieving compliance with more than one NPDWR at a time. When considering treatment technologies, the impact of any new technology on existing water quality and treatment processes must be considered. In addition, the impact of changing treatment processes on the quality of water in the distribution system must be given special consideration. Pumping a higher quality of water into the distribution system may not necessarily mean better quality drinking water for consumers, depending on the condition of and other factors associated with operation and maintenance of the distribution system. Surface water systems using conventional treatment face the greatest challenge in addressing simultaneous compliance issues. These systems must comply with several different treatment technique regulations:
Turbidity removal requirements under the Surface Water Treatment Rule (SWTR), as strengthened by the Interim Enhanced Surface Water Treatment Rule (IESWTR) for large systems and the Long Term 1 Enhanced Surface Water Treatment Rule (ESWTR) for small systems.
Enhanced coagulation requirements for total organic carbon (TOC) removal under the Stage 1 Disinfectants=Disinfection Byproducts Rule (Stage 1 D=DBPR).
Optimal corrosion control under the Lead and Copper Rule (LCR). USEPA (1999) has provided guidance regarding water treatment conflicts and solutions in achieving simultaneous compliance with microbial and disinfection byproduct rules. Potential conflicts could arise between existing and future technology choices affecting compliance with any of the NPDWRs. Two notable examples include
Changing disinfection practice to meet DBP MCLs under the Stage 1 DBPR could affect distribution system microbiological quality and compliance with the TCR
Adjusting distributed water pH upward to meet the lead and copper rule action levels could affect DBP formation and compliance with DBP MCLs Simultaneous compliance issues and conflicts between regulatory requirements on water quality must be carefully considered. Typically, USEPA establishes regulations based on SDWA mandates with little or no consideration of the compounding effects on water quality of multiple rules and treatment requirements. As noted above, guidance has been provided regarding water treatment conflicts and solutions in

396

SELECTION OF TREATMENT TECHNOLOGY FOR SDWA COMPLIANCE

achieving simultaneous compliance with microbial and disinfection byproduct rules (USEPA 1999). But each water system must carefully consider their particular situation.

15.6

PROCESS OPTIMIZATION

Before a water utility invests in new treatment technology, every effort should be made to ensure that existing treatment processes are operating optimally. Water utilities should obtain the best treatment performance from existing processes. In many cases, optimizing treatment using the Composite Correction Program (USEPA 1991) or by modifying existing processes will result in compliance with new regulations and avoid costly capital improvements. Each water system must assess the potential for performance improvement on a case-by-case basis. Optimization of conventional treatment is also being considered as a partial means of compliance with the anticipated USEPA Long Term 2 Enhanced Surface Water Treatment Rule (LT2ESWTR).

15.7

TECHNOLOGY SELECTION

Historically, the water industry has adapted to new technologies on a slow, incremental pace. Since the early 1980s, a much more rapid entry of new technologies into the municipal water treatment market has occurred. SDWA requirements affect the introduction and acceptance of new technologies. Processes such as membrane technology, UV disinfection, ozonation, and IX and inorganic adsorbent media are already well accepted. Other technologies are being considered and researched, such as biological filtration. As technology costs decrease, applicability will steadily increase. Many factors influence the selection of water treatment technologies. The specific influence of SDWA requirements has been reviewed in this chapter. The influence diagram shown in Figure 15.2 illustrates general factors affecting technology selection. When the water utility decisionmaker makes a technology selection, the choice of technology is normally made on the basis of information available at the time of the decision. The influence diagram in Figure 15.2 is not a flow diagram, showing sequential steps. Rather, the influence diagram shows those key factors influencing that decision when it is made (Clemen and Reilly 2001). Indeed, there may be other factors influencing a technology selection in addition to those shown in Figure 15.2 specific to each situation. Sophisticated decision algorithms can be applied for selecting treatment technologies. But ultimately, technology selection will be as much an art as a science, because judgments must be made with information that is typically incomplete, such as the effect of potential future regulatory requirements, future source water quality, future population growth, and future water demand.

15.7 TECHNOLOGY SELECTION

397

Figure 15.2 Influence diagram of factors affecting treatment technology selection at any given point in time.

The factors illustrated in Figure 15.2 have been grouped into four general areas:
SDWA Requirements. Does the water system desire a variance, small system variance, or exemption? If so, what technology options are available and what additional requirements will be imposed by state regulators? What technologies are affordable? Are alternative water sources available? Is consolidation with a nearby system or management restructuring a possible alternative? If not, is the new technology under consideration designated as BAT by USEPA? If not, why not? Should the burden of specific regulatory compliance and reporting associated with a technology be considered in technology selection?

398

SELECTION OF TREATMENT TECHNOLOGY FOR SDWA COMPLIANCE


Compliance Considerations. How will treatment technology under consideration achieve compliance with current MCLs and TTs? How will treatment technology under consideration enable the water system to comply with anticipated future rules?
Water Quality Objectives. How will treatment technology under consideration allow the water system to achieve its own water quality objectives, produce aesthetically acceptable water, and meet consumer preferences and expectations? Should the possibility of deliberate contamination of source waters (i.e., biological agents, chemical agents) be a consideration in technology selection? Will the new technology adversely affect the performance of other existing treatment technology?
Technological Considerations. Have existing treatment processes been optimized, and are they performing to their maximum capability? What is their remaining useful life, and are they cost-efficient relative to newer technologies? Is the treatment technology under consideration acceptable to state regulators? If not, what must be done to achieve state regulatory acceptance? What treatment technologies are most attractive from a capital cost and O&M cost? What newer technologies are now available? Will staffing levels be increased, decreased, or remain the same? How will the procurement process affect technology selection? The procurement process used for the design, construction, and operation of new treatment facilities can also affect technology selection. The traditional approach is for the water utility to bid and hire a firm for the design (D), then bid and proceed with construction [build (B)], and then operate (O) the system under separate contracts or phases (DþBþO). Many municipally owned water utilities hire a team of consultants=contractors to conduct simultaneously the design and construction of new water treatment facilities, and then the water utility will operate the system (DBþO). Alternatively, some municipally owned water utilities are partially privatizing by entering into long-term contracts for a team of consultants, contractors, and management companies to design, build, and operate (DBO) new water treatment facilities. In some cases, water utilities work directly with a treatment technology manufacturer or supplier and a contractor to install a treatment system, bypassing the traditional design consultant. Certain technologies will be more amenable to particular procurement methods, especially if time is of high priority. Virtually every contaminant can be removed from water by applying a sequence of several treatment processes. The key issue, of course, is that of cost. As water resources become decreasingly available, the need for innovative and costeffective treatment technologies will rise steadily. Water utilities may use any technology acceptable to the state primacy agency to comply with SDWA regulations. They should strive to achieve a superior water quality for consumers far better than that required by regulation through prudent selection of cost effective technologies.

REFERENCES

399

REFERENCES Aieta, E. M., K. M. Reagan, and J. S. Lang. 1988. Advanced oxidation processes for treating groundwater contaminated with TCE and PCE: Pilot-scale evaluations. J. Am. Water Works Assoc. 80(5):64. ANSI=NSF Standard 55. 1991. Ultraviolet Microbiological Water Treatment Systems. Ann Arbor, MI: NSF International. AWWA Research Foundation=Lyonnaise des Eaux=Water Research Commission of South Africa. 1996. Water Treatment Membrane Processes. J. Mallevialle, P. E. Odendaal, and M. R. Wiesner, eds. New York: McGraw-Hill. AWWARF and CGE. 1991. Ozone in Water Treatment: Applications and Engineering. Cooperative Research Report. B. Langlais, D. A. Reckhow, and D. R. Brink, eds. Chelsea, MI: Lewis Publishers. Bergman, R. A. 1992. Nanofiltration System Components and Design Considerations. Proc. 1992 AWWA Annual Conf., Vancouver, Canada. Bergman, R. A. 1996. Cost of Membrane Softening in Florida. J. Am. Water Works Assoc. 88(5):32. Bolton, J. R., B. Dussert, Z. Bukhari, T. Hargy, and J. L. Clancy. 1998. Proc. AWWA 1998 Annual Conf., Dallas, TX, Vol. A, pp. 389–403. Campbell, A. T. and P. Wallis. 2002. The effect of UV irradiation on human-derived Giardia lamblia cysts. Water Research 36:963–969. Chellam, S., J. G. Jacangelo, T. P. Boacquisti, and B. W. Long. 1997. Effect of operating conditions and pretreatment for nanofiltration of surface water. Proc. AWWA Membrane Technology Conf., New Orleans, LA. Clark, R. M., M. Sivagenesan, E. W. Rice, and J. Chen. 2002. Development of a Ct equation for the inactivation of Cryptosporidium oocysts with ozone. Water Research 36:3141–3149. Clemen, R. T. and T. Reilly. 2001. Making Hard Decisions with DecisionTools. Pacific Grove, CA: Duxbury. Clifford, D. A. 1990. Ion Exchange and Inorganic Adsorption. In Water Quality and Treatment. A Handbook of Community Water Supplies, 4th ed. F. W. Pontius, ed. New York: McGrawHill. Coffey, B. M., P. M. Huck, E. J. Bouwer, R. M. Hozalski, B. Pett, and E. F. Smith. 1997. The Effect of BOM and temperature on biological filtration: An integrated comparison at two treatment plants. Proc. AWWA Water Quality Technology Conf., Denver, CO. Congress. 1974. House of Representatives Report 93-1185. Washington, DC: U.S. Government Printing Office. Congress. 1986. Congressional Record 132:S6287 (May 21). Conlon, W. J. and S. A. McClellan. 1989. Membrane softening: A water treatment process comes of age. J. Am. Water Works Assoc. 81(11):47. Emelko, M. B., P. M. Huck, and E. F. Smith. 1997. Full-scale evaluation of backwashing strategies for biological filtration. Proc. AWWA Annual Conf., Atlanta, GA. Glaze, W. H., J. W. Kang, and D. H. Chapin. 1987. The chemistry of water treatment processes involving ozone, hydrogen peroxide, and ultraviolet radiation. Ozone, Sci. Eng. 9:335. Huffman, D. E., A. Gennaccaro, J. B. Rose, and B. W. Dussert. 2002. Low- and medium-pressure UV inactivation of Microsporidia Encephalitozoon intestinalis. Water Research 36:3161–3164.

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Jacangelo, J. G., S. S. Adham, and J.-M. Laine. 1995. Mechanism of Cryptosporidium, Giardia, and MS2 virus removal by MF and UF. J. Am. Water Works Assoc. 87(9):107. Karanis, P., W. A. Maier, H. M. Seitz, and D. Schoenen. 1992. UV Sensitivity of Protozoan Parasites. J. Water Supply Research Technol—Aqua 41(2):95. Karimi, A. A., J. A. Redman, W. H. Glaze, and G. F. Stolarik. 1997. Evaluating an AOP for TCE and PCE Removal. J. Am. Water Works Assoc. 89(8):41. Kruithof, J. C., R. C. van der Leer, and W. A. M. Hijnen. 1992. Practical experiences with UV disinfection in the Netherlands. Aqua 41(2):88. Kruithof, J. C., P. Hiemstra, P. C. Kamp, J. P. van der Hoek, J. S. Taylor, and J. C. Schippers. 1997. Integrated multi-objective membrane systems for control of microbials and DBP precursors. Proc. AWWA Membrane Technology Conf., New Orleans, LA. Linden, K. G., G.-A. Shin, G. Faubert, W. Cairns, and M. D. Sobsey. 2002. UV disinfection of Giardia lamblia cysts in water. Environ. Sci. Technol. 36:2519–2522. Logsdon, G., A. Hess, and M. Horsley. 1999. Guide to selection of water treatment processes. In Water Quality and Treatment, 5th ed. New York: McGraw-Hill. Lozier, J. C., G. Jones, and W. Bellamy. 1997. Integrated membrane treatment in Alaska. J. Am. Water Works Assoc. 89(10):50. Matsuura, T. 1993. Future trends in reverse osmosis membrane research and technology. In Reverse Osmosis: Membrane Technology, Water Chemistry, and Industrial Applications. Z. Amjad, ed. New York: Chapman & Hall. Mofidi, A. A., E. A. Meyer, P. M. Wallis, C. I. Chou, B. P. Meyer, S. Ramalingam, and B. M. Coffey. 2002. The effect of UV light on the inactivation of Giardia lamblia and Giardia muris cysts as determined by animal infectivity assay (P-2951-01). Water Research 36:2098–2108. Najm, I. N. and R. R. Trussell. 1999. New and emerging drinking water treatment technologies. In Identifying Future Drinking Water Contaminants. Washington, DC: National Academy Press. Parrotta, M. J. and F. Bekdash. 1998. UV disinfection of small groundwater supplies. J. Am. Water Works Assoc. 90(2):71. Pontius, F. W. 2002. Regulatory compliance planning to ensure water supply safely. J. Am. Water Works Assoc. 94(3):52–64. Pontius, F. W., P. Damian, and A. E. Eaton. 2000. Regulation of perchlorate in drinking water. In Perchlorate in the Environment. E. T. Urbansky, ed. New York: Plenum=Kluwer. Rice, W. E. and J. C. Hoff. 1981. Inactivation of Giardia lamblia cysts by ultraviolet irradiation. Appl. Environ. Microbiol. 42:546–547. Scott, K. 1995. Handbook of Industrial Membranes. Oxford, UK: Elsevier Advanced Technology, Ltd. Tan, L. and G. L. Amy. 1989. Comparing ozonation and membrane separation for color removal and disinfection by-product control. J. Am. Water Works Assoc. 83(5):74. Tripp, A. R. and D. A. Clifford. 2000. The treatability of perchlorate in groundwater using ion-exchange technology. In Perchlorate in the Environment. E. T. Urbansky, ed. New York: Kluwer=Plenum. Trussell, R. R. and I. N. Najm. 1999. Application of advanced oxidation processes for the destruction of DBP precursor. In Formation and Control of Disinfection By-Products in Drinking Water. P. C. Singer, ed. Denver: AWWA.

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USEPA. 1991. Handbook; Optimizing Water Treatment Plant Performance Using the Composite Correction Program. EPA=625=6-91-027. Cincinnati: Office of Drinking Water. USEPA. 1996. Ultraviolet Light Disinfection Technology in Drinking Water Application—An Overview. EPA 811-R-96-002. Washington, DC: Office of Ground Water and Drinking Water. USEPA. 1997. Small System Compliance Technology List for the Surface Water Treatment Rule. EPA 815-R-97-002. Washington, DC: Office of Ground Water and Drinking Water. USEPA 1998a. Small System Compliance Technology List for the Surface Water Treatment Rule and Total Coliform Rule. EPA 815-R-98-001. Washington, DC: Office of Water. USEPA 1998b. Small System Compliance Technology List for the Non-Microbial Contaminants Regulated before 1996. EPA 815-R-98-002. Washington, DC: Office of Water. USEPA 1998c. Variance Technology Findings for Contaminants Regulated before 1996. EPA 815-R-98-003. Washington, DC: Office of Water. USEPA. 1999. Microbial and Disinfection Byproduct Rules Simultaneous Compliance Guidance Manual. EPA 815-R-99-015. Washington, DC: Office of Water. USEPA. 2001a. Low-Pressure Membrane Filtration for Pathogen Removal: Application, Implementation, and Regulatory Issues. EPA 815-C-01-001. Washington, DC: Office of Water. USEPA. 2001b. Ultraviolet Disinfection Guidance Manual (draft CD-ROM). Washington, DC: Office of Ground Water and Drinking Water. Vickers, J. C., A. Braghetta, and R. A. Hawkins. 1997. Bench scale evaluation of microfiltration-nanofiltration for removal of particles and natural organic matter. Proc. AWWA Membrane Technology Conf., New Orleans. Wang, J. Z., R. S. Summers, and R. J. Miltner. 1995. Biofiltration Performance: Part 1, Relationship to Biomass. J. Am. Water Works Assoc. 87(12):55. Wiesner, M. R., J. Hackney, S. Sethi, J. G. Jacangelo, and J.-M. Laine. 1994. Cost estimates for membrane filtration and conventional treatment. J. Am. Water Works Assoc. 86(12):33. Yoo, R. S. et al. 1995. Microfiltration: A case study. J. Am. Water Works Assoc. 87(3):38.

16 SDWA COMPLIANCE USING POINT-OF-USE (POU) AND POINT-OF-ENTRY (POE) TREATMENT FREDERICK W. PONTIUS, P.E. Pontius Water Consultants, Inc., Lakewood, Colorado

REGU P. REGUNATHAN, Ph.D. ReguNathan & Associates, Inc., Wheaton, Illinois

JOSEPH F. HARRISON, P.E., CWS-VI Technical Director, Water Quality Association, Lisle, Illinois

16.1

INTRODUCTION

The 1996 Amendments to the Safe Drinking Water Act (SDWA) allow public water systems to install point-of-use (POU) and point-of-entry (POE) treatment devices to achieve compliance with National Primary Drinking Water Regulations (NPDWRs). POU and POE treatment devices use treatment technologies similar to those applied in central treatment plants. Whereas central treatment plants treat all water to be distributed to all consumers to the same degree, POU and POE treatment devices treat only a portion of the total flow. POU devices treat only the water intended for direct consumption at a single tap within a single home or structure. POE treatment devices treat all water used within a single home or structure. Some water systems may find POU or POE to have cost advantages over central treatment, enabling them to provide increased protection to their consumers than they might otherwise have been able to afford. This chapter discusses technical and managerial issues involved in using POU or POE treatment for SDWA compliance. Centrally managed POU and POE treatment have been effective compliance approaches in rural areas and small communities. For many of these systems, constructing, upgrading, or expanding a central treatment plant is too expensive Drinking Water Regulation and Health, Edited by Frederick W. Pontius. ISBN 0-471-41554-5 # 2003 John Wiley & Sons, Inc.

403

404

SDWA COMPLIANCE USING POU AND POE TREATMENT

or demands a high degree of technical expertise not readily available. Technological developments are improving the effectiveness and decreasing the cost of POU and POE treatment equipment. Small systems may find POU or POE treatment effective for compliance with a NPDWR. Large water systems may also benefit from POU or POE technology to solve area-specific water quality problems. Water systems of all sizes may desire to offer customers, especially sensitive subpopulations, a choice to increase their level of protection against certain contaminants by offering POU or POE technology as a customer service.

16.2

POU AND POE TECHNOLOGY BENEFITS

The U.S. Environmental Protection Agency (USEPA) has approved centrally managed POU and POE treatment devices as a means to achieve compliance with maximum contaminant levels (MCLs) established in the NPDWRs. However, POU units may not be used to comply with the MCL for microbial contaminants or indicators for microbial contaminants. POU and POE technologies are summarized in Table 16.1. TABLE 16.1

POU=POE Technologies

Treatment Type Reverse osmosis

Cation exchange Anion exchange Activated alumina Direct (mechanical) filtration Activated carbon Distillation UV light

Effective for These Regulated Primary Contaminants

Also Effective for These Secondary= Unregulated Contaminants

Arsenic(V), barium, cadmium, chromium, copper, lead, mercury, fluoride, nitrate, selenium, radium, some organics, herbicides, and pesticides Barium, cadmium, chromium(III), copper, lead, mercury, radium Nitrate, selenium(VI), arsenic(III), arsenic(V), chromium(VI) Fluoride, arsenic, selenium(IV) Turbidity, cysts

Total dissolved solids, chloride, silver, sulfate, foaming agents, corrosion products, perchlorate, microbiological contaminants

Organics, organic mercury, VOCs, TTHMs, PCBs, SOCs Metals, high-molecular-weight organics, microbiological contaminants Microbiological contaminants (Cryptosporidium, etc.), bromate

Zinc, iron, manganese Chloride, sulfate

Color, foaming agents, taste and odor, MTBE Total dissolved solids, chloride, sulfate

16.3 POU AND POE TECHNOLOGY LIMITATIONS

405

Many small communities have successfully applied POU and POE treatment devices to solve water quality problems (see Table 16.2). Implementing POU or POE treatment may be substantially less expensive than building, expanding, or upgrading a central treatment plant because only a portion of water used in the household is treated to the highest level. To illustrate, USEPA determined that POU treatment for arsenic is less expensive than central treatment for communities of fewer than 40 households (USEPA 1998b). Also, POU and POE rental units are available from several vendors for less than $25 per month per household. Use of rental units eliminates initial capital costs and financing for the water utility. Studies suggest that some POU and POE treatment technologies may provide small water system customers with equal or better protection from certain contaminants than central treatment at a lower cost. In some cases, for example, total trihalomethanes (TTHMs) may be removed to a lower concentration with POU treatment than is economically feasible with central treatment (Lykins et al. 1992).

16.3

POU AND POE TECHNOLOGY LIMITATIONS

POU and POE treatment have several potential disadvantages. Regular access to treatment units is necessary and may be difficult because treatment units will usually be located within customer homes. Regular access must be ensured. In some cases, a local government ordinance may be needed guaranteeing water system personnel access to service treatment units and to collect water samples. In addition, to meet the legal responsibility to provide water in compliance with all NPDWRs, the water system may also have to pass an ordinance that requires all customers to use POU or POE treatment units. In such cases, the water system should also have the authority to shut off a customer’s water if the customer refuses to allow installation and maintenance of, tampers with, bypasses, or removes the treatment unit. Poor or widely varying water quality, especially microbiological quality, may prevent the safe operation of POU or POE treatment devices. Pilot testing is typically necessary to identify potential water quality problems. Finally, media or membranes used in POU and POE treatment devices may be susceptible to microbial colonization. Higher levels of bacteria have been found in treated water produced by some POU and POE devices than in the corresponding untreated water (Payment et al. 1991). This is especially true of those devices that use activated carbon (Dufour 1988). Potential health risks posed by microbiological growth appear to be low or nonexistent (Snyder et al. 1995). It is not unusual to find high heterotrophic plate count (HPC) bacteria levels in drinking water distribution systems and especially at any drinking water faucet or spigot. At an International HPC Symposium held in Geneva, Switzerland (WHO 2002) in April 2002, data were presented showing more than 97% of exposure to HPC bacteria comes from foods—less than 3% from drinking water. Moreover, the consensus from the conference was that, absent obvious sanitary contamination, there is no evidence that consuming such waters with high HPC levels alone poses a health risk. However, additional monitoring and posttreatment disinfection may be required by some states

406

73 18 10 67 50

12

63 29

Rockaway Township, NJ

Emington, IL Lewisburg, OH

Number of Households Arsenic, fluoride, TDS Various Halogenated organics VOC–petroleum tastes and odors VOCs (trichloroethylene and others) VOCs (trichloroethylene and others) Fluoride, TDS Barium, lead, cadmium, arsenic

Contaminant

Examples of POU=POE Treatment Installations

San Ysidro, NM Long Island, NY Gulf South Field Study Lake Carmel, NY Silverdale, PA

Site

TABLE 16.2

POU RO POE softener and POU AA=POU RO

POU carbon

POU RO Several (POU) Carbon filters POE GAC-UV POU carbon

Device Used

>80 Effluents below MCL levels

>95

>90 >90 76–99 >80 >95

Approximate Percent Reduction Achieved

16.4 SDWA REQUIREMENTS FOR POU AND POE TECHNOLOGY

407

with an intent on their part to ensure customer safety, thus increasing overall costs. WHO suggested appropriate maintenance of water treatment devices for aesthetic reasons, according to manufacturers’ recommendations (WHO 2002). These factors may result in some systems deciding to not pursue POU or POE treatment. But each water system must make this assessment on a case-by-case basis. In each case, the advantages of POU or POE treatment must be weighed against the disadvantages.

16.4

SDWA REQUIREMENTS FOR POU AND POE TECHNOLOGY

The SDWA [Sec. 1412(b)(4)(E)(ii)] regulates the design, management, and operation of POE and POU treatment units used to achieve compliance with a MCL. These restrictions are listed in Table 16.3 and discussed below:  POU treatment units may not be used to achieve compliance with a MCL or treatment technique for a microbial contaminant or an indicator of a microbial contaminant.  POE devices may be used to achieve compliance with a MCL for a microbial contaminant or an indicator of a microbial contaminant. Although generally not recommended, POE treatment may be used to comply with the Total Coliform Rule, the Surface Water Treatment Rule, and the Interim Enhanced Surface Water Treatment Rule (USEPA 1999a).  POU and POE units must be owned, controlled, and maintained by the water system or by a contractor hired by the water system to ensure proper operation and maintenance of the devices and compliance with MCLs. The water system must retain oversight of unit installation, maintenance, and sampling. The water system staff need not perform all maintenance or management functions (these tasks may be contracted to a third party), but the final responsibility for the quality and quantity of the water provided to the community resides with the water system. Indeed, the water system must closely monitor all contractors. Responsibility for the operation and maintenance of POU or POE devices installed for SDWA compliance may not be delegated to homeowners. TABLE 16.3 Restrictions on POU and POE Treatment for SDWA Compliance POU devices cannot be used to comply with MCLs for microbial contaminants The water system must maintain ultimate control over all POU and POE units Both POU and POE devices must be designed to automatically notify customers of operational problems POU and POE devices used to achieve compliance with an MCL must be certified according to ANSI=NSF standards if such certification is available POU devices should not be used to treat for radon or for volatile organic contaminants

408

SDWA COMPLIANCE USING POU AND POE TREATMENT

 POU and POE units must have mechanical warnings to automatically notify customers of operational problems. Each POU or POE treatment device must be equipped with a warning device (alarm, light, etc.) that will alert users when their unit is no longer adequately treating their water. Alternatively, units may be equipped with an automatic shutoff mechanism to meet this requirement. To illustrate, several communities have implemented POU or POE treatment strategies using units equipped with water meters and automatic shutoff devices to disable the units after a prespecified amount of water has been treated to prevent contaminant breakthrough.  If the American National Standards Institute (ANSI) has issued product standards for a specific type of POU or POE treatment unit, then only those units that have been independently certified according to these standards may be used as part of a compliance strategy. POE units treat all water used in a household. POU treatment devices treat the water at only a single tap. Hence, POU devices are not appropriate for treating contaminants that represent an acute threat to human health (e.g., nitrate) or for treating contaminants that may have a negative impact on health as a result of inhalation or dermal contact. However, because all water intended for consumption (drinking or cooking) is treated if a POU device is installed at the kitchen tap, USEPA believes that POU devices meet the requirements of the SDWA as long as they reduce the concentration of the contaminant of concern below the MCL. Although not explicitly prohibited in SDWA, USEPA indicates that POU treatment devices should not be used to treat for radon or for most volatile organic contaminants (VOCs) to achieve compliance, because POU devices do not provide adequate protection against inhalation or contact exposure to these contaminants at untreated taps (e.g., showerheads).

16.5

CERTIFICATION PROGRAMS

Certification of POU and POE devices ensures that the performance of the units match the claims of the manufacturer. ANSI has adopted the standards for POU and POE devices developed by NSF International (NSF), formerly the National Sanitation Foundation. If no standard has been established by ANSI for a particular treatment device, states should utilize manufacturers’ substantiation of product performance and results from other field installations and tests to evaluate acceptance of the technology or products for a specific application. POU and POE devices must be independently certified according to the applicable NSF standard(s) by an accredited laboratory. Lists of certified devices are available on the Internet from the certifying laboratories of NSF (www.nsf.org/ Certified/DWTU/ ), Underwriters Laboratories (UL) (www.ul.com), and the Water Quality Association (WQA) Gold Seal Program (www.wqa.org). Units certified to

16.5 CERTIFICATION PROGRAMS

409

meet the requirements of one or more of the above standards are evaluated for the following:  Verification of contaminant reduction as claimed by the manufacturer and as required in the standard. A unit may be effective in controlling many different contaminants, but it is not required to control all contaminants covered by a particular standard.  Structural integrity to ensure the unit’s capability to withstand water pressures in the home.  Toxicological assessment and extraction testing of all materials in contact with water for product safety.  Review and acceptance of all sales literature and labeling as per the test results for the specific contaminants. ANSI=NSF standards cover six types of POU and POE devices described below:  Standard 42: Drinking Water Treatment Units—Aesthetic Effects. This standard applies to several types of filters and adsorption units. It covers contaminants that can affect the taste, odor, and color of the drinking water, including many USEPA secondary contaminants. The devices include activated carbon units and several grades of particulate filtration units, along with certain chemical feed mechanisms. Some of the claims covered by this standard include bacteriostatic effects, taste and odor reduction, chlorine reduction, chloramine reduction, particulate reduction in six different levels of capability, iron reduction, and scale and corrosion control feed levels.  Standard 44: Cation Exchange Water Softeners. Covers residential point of entry water softeners designed to remove hardness and reduce other specific contaminants such as barium and radium. Sodium chloride or potassium chloride can be used as a regenerant.  Standard 53: Drinking Water Treatment Units—Health Effects. This standard applies to several different types of units and covers contaminants that may affect human health if present in concentrations exceeding regulatory levels. Devices include activated carbon units, ion exchange units, fine filtration units, and different types of adsorptive units. Claims covered by this standard include filterable cyst reduction, lead reduction, TTHM reduction, and VOC reduction. Units allowed to make VOC reduction are tested to provide 95% reduction from a 300-ppb challenge level of chloroform. Units that successfully pass the chloroform reduction test are then allowed to claim a list of 51 different VOCs including many of the halogenated disinfection byproducts (DBP) as shown in Table 16.4. Use of chloroform as a surrogate has been verified by NSF through extensive testing. Standard 53 has been recently expanded to include protocols for the removal of arsenic(V), and is currently (2003) being examined to define and include protocols for the removal of arsenic(III).

410

SDWA COMPLIANCE USING POU AND POE TREATMENT

TABLE 16.4 Contaminants That May be Claimed Under The Chloroform Reduction Test of ANSI=NSF Standard 53 Alachlor Atrazine Benzene Carbofuran Carbon tetrachloride Chlorobenzene Chloropicrin 2,4-D Dibromochloropropane o-Dichlorobenzene p-Dichlorobenzene 1,2-Dichloroethane 1,1-Dichloroethylene cis-1,2-Dichloroethylene trans-1,2-Dichloroethylene

1,2-Dichloropropane cis-1,3-Dichloropropylene Dinoseb Endrin Ethylbenzene Ethylene dibromide Haloacetonitriles Haloketones Heptachlor Heptachlor epoxide Hexachlorobutadiene Hexachlorocyclopentadiene Lindane Methoxychlor Pentachlorophenol

Simazine Styrene 1,1,2,2-tetrachloroethane Tetrachloroethylene Toluene 2,4,5-TP (Silvex) Tribromoacetic acid 1,2,4-Trichlorobenzene 1,1,1-Trichloroethane 1,1,2-Trichloroethane Trichloroethylene Trihalomethanes Xylenes

 Standard 55: Ultraviolet Microbiological Water Treatment Systems. This standard defines two classes of UV systems: Class A system—designed to disinfect microbiologically contaminated water that meets all other public health standards. The system is not designed for water obviously contaminated with raw sewage. These units are required to have built-in sensors, alarms, and=or solenoids and demonstrate a dose level higher than 40,000 (mW
s)=cm2. Class B system—designed for supplemental treatment of public or other drinking water that has been tested and considered safe for human consumption. This is meant for nonpathogenic or nuisance organisms only, even though a dose level higher than 16,000 (mW
s)=cm2 has to be demonstrated. No UV sensors, alarms, or shutoff devices are required. An NSF task group to expand the scope of Standard 55 to include other microbiological disinfection processes and to upgrade the test protocols is currently (2002) examining this standard.  Standard 58: Reverse Osmosis Drinking Water Treatment Systems. This standard applies to systems where water is forced by pressure through a semipermeable membrane. POU reverse osmosis (RO) systems incorporate pre- and postfilters, which can be certified separately under Standard 42 and=or 53. Claims covered by Standard 58 include many of the heavy metals, arsenic(V), nitrates, and total dissolved solids (TDS). Units can also be tested and verified for the reduction of asbestos fibers, filterable cysts, turbidity, and VOC reduction if an appropriate certified carbon based unit is part of the system.

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 Standard 62: Drinking Water Distillation Systems. This standard applies to batch and flowing distillation systems that reduce dissolved contaminants by heat converting water to vapor and subsequent condensation to liquid. Claims include reduction of many inorganic and microbiological contaminants along with some larger organic contaminants. When coupled with a carbon device certified under Standard 42 and=or 53 additional claims for removal of other organics may also be made.

16.6

POU AND POE TECHNOLOGY OVERVIEW

POU and POE units have specific performance characteristics depending on the technology applied, on the design of the unit, and on the quality of water being treated. A particular unit may perform significantly more or less effectively depending on the characteristics of the water being treated. A treatment technology that is effective in removing a particular contaminant in one community may not necessarily be effective for removing the same contaminant in another community. 16.6.1

POU Carbon Units

Activated carbon based POU filter systems are available in various forms: granular, solid block, and precoat (Fig. 16.1). All forms can be designed to be very effective in eliminating common taste and odor problems, including those posed by the presence

Figure 16.1

POU activated carbon system (source: Water Quality Association).

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SDWA COMPLIANCE USING POU AND POE TREATMENT

of chlorine and chloramines. Units with granular activated carbon (GAC), the most commonly used form of carbon, are effective in removing pesticides, chlorine, chlorine byproducts such as chloroform and other trihalomethanes, as well as other organic contaminants. Larger suspended particles may also be removed. But GAC filters do not provide the same fine filtration as solid block and precoat carbon filters, which can strain particles down to 1 mm in size. The finer filtration provided by precoat and solid block carbon, both of which contain fine powdered carbon coated onto a fine filtration septum or solidified with a plastic resin into a rigid block, is effective in reducing more contaminants including all that are removed by GAC plus some heavy metals and cysts such as Cryptosporidium and Giardia. Carbon block filters are widely used for the reduction of many VOC and TTHM organics found in chlorinated waters. Solid block and precoat filters, however, are generally limited to POU treatment for drinking and cooking water. POE systems for whole-house water treatment utilize larger tanks of GAC.

16.6.2

POU Reverse-Osmosis Devices

A well-known water treatment process, RO reverses naturally occurring osmosis by applying pressure to water with higher dissolved solids, forcing it through a semipermeable membrane, to become virtually free of solids on the other side. The use of RO in POU applications has several unique features (Fig. 16.2). Water flows through a shutoff valve to the prefilters, which may be combined into one housing in some systems. An automatic shutoff valve is preferably used to make certain that the unit does not waste water to drain when the storage tank is full. If a thin-film composite (TFC) membrane is used, then a prefilter is needed to remove chlorine prior to the membrane. Oxidants such as chlorine can degrade the TFC membrane. In systems with built-in monitoring capabilities, two probes are used—one for feedwater and the other for product water—to sense TDS levels and issue a warning when the product water level exceeds a preset percentage. Water flowing through the RO module splits into two streams. The reject stream flow is controlled by a flow control device to an airgap required by local health authorities before being directed to the drain line. Product water flows through a check valve and the automatic shutoff valve to a storage tank that is pressurized by air on the other side of the diaphragm in the tank. Stored water then has enough pressure available for the user when the RO faucet is opened. This product water from the tank passes through a carbon postfilter to reduce taste and odor concerns and the product water probe to sense the acceptability of the treated water before it is served from the faucet. This type of system, when operated under normal household line pressure of 40–80 psi, can deliver all the cooking and drinking water needs of a large family. With some variations in specific equipment, this design generally applies to all manufacturers. Removal capabilities of RO products with postfiltration carbon treat-

413 Figure 16.2

POU RO application (source: Water Quality Association).

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SDWA COMPLIANCE USING POU AND POE TREATMENT

ment for most health-related organic and inorganic contaminants make them appropriate for meeting the SDWA compliance requirements of many small utilities. 16.6.3

POU UV Devices

Ultraviolet (UV) disinfection has been practiced with POU and POE treatment for many decades. Many of POU UV units are designed to provide a UV dose of 16,000 (mW
s)=cm2, but do not have built in sensors or alarms because of the high cost of incorporating such components. UV products tested for Class B disinfection performance per NSF Standard 55 provide a minimum of 2 log reduction of bacterial organisms and are to be used only on waters that have already been disinfected to be microbiologically safe at a central water treatment plant. Class B units can provide an additional insurance barrier at the point of use, which may also be of interest to some health-sensitive populations. Class A devices are required to provide 40,000 (mW
s)=cm2. These units are equipped with monitoring sensors to warn the user when for any reason the UV intensity level goes below the preset level. Few POE units have been tested and certified as Class A, and no POU devices are certified as Class A by any of the testing agencies at this time (2003). 16.6.4

POU Distillers

Water distillers for home can be either air-cooled or water-cooled and batch or continuous-fill units. Water is heated to boiling producing steam that passes to a cooling chamber or into a cooling coil and is then condensed into treated product water (Fig. 16.3). Dissolved solids and higher boiling-point liquids stay behind in the boiling chamber, while lower-boiling substances are vented out as vapor. These

Figure 16.3

POU distillation system (source: Water Quality Association).

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devices can be completely automatic, semiautomatic, or manually operated. Batch distillers are filled manually but can operate further on an automatic basis to shut down when the process is completed. All distillers must be cleaned periodically to remove scale buildup inside the boiling chambers. Ease of cleaning is dependent on the design of the unit by the manufacturer. In addition to the natural heat-based inactivation of all microorganisms, distillers also remove dissolved inorganic ions. ANSI=NSF Standard 62 provides protocols for such reduction tests. All units currently (2003) tested and certified can reduce arsenic, tri- and hexavalent chromium, selenium, copper, lead, cadmium, fluoride, mercury, and TDS. 16.6.5

POU Activated Alumina (AA) and Adsorptive Media Units

Activated-alumina-based products have been used for the reduction of fluoride, selenium, and arsenic for many years. POU products using such media have not been very prevalent in the past. This is rapidly changing because of renewed interest in these products for meeting a lower arsenic MCL. Many manufacturers are working to release products using one of several types of adsorptive media, including unmodified AA, manganese-modified or iron-modified alumina, and iron-based granules. These media can be used similar to GAC packed into cartridge columns and inserted into housings. Arsenic adsorption products can soon be tested using protocols being completed as part of ANSI=NSF Standard 53. This protocol calls for a synthesized water with interfering chemicals and fortified with arsenic(V) or arsenic(III) operated in an accelerated cycle of water use to ascertain its capacity. 16.6.6

Other POU Products

There are several other types of POU products available to consumers. Mechanical filtration devices without any activated carbon incorporated in them are available. These are usually prefilters for coarse filtration of larger particles protecting downstream treatment from premature clogging. More recently, fine mechanical filtration devices using microfiltration and ultrafiltration processes have been developed leading to health-based contaminant reduction claims such as cyst reduction or even bacteria and virus reduction capabilities. These are yet to undergo testing and certification by third-party organizations. Countertop and under-the-sink ozonators have also been developed and are being made available to consumers interested in additional protection from microbial contaminants. An effort is under way at NSF International to develop an ANSI standard to enable such units to be tested and certified. 16.6.7

POE Products

Water softeners using cation-exchange resins to soften water by removing hardness are the best-known POE products in the United States. They operate by having the water flow through a bed of ion exchange resin in sodium form to exchange calcium

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SDWA COMPLIANCE USING POU AND POE TREATMENT

and magnesium present in the water supply for sodium (Figs. 16.4 and 16.5). When the bed is exhausted, it is regenerated by introducing a concentrated salt solution to reverse the process. This can be done with either sodium salt or potassium salt, which works in a similar manner. Water softeners can be either manually operated or totally automatic. More recently developed units have many unique features, includ-

Figure 16.4

How a POE water softener works (source: Water Quality Association).

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Figure 16.5 Typical POE home water softener with automatic controller for regeneration and service (source: Water Quality Association).

ing demand initiated regeneration and a means of remotely signaling the need for service. While softeners have been used essentially to control aesthetic water quality, their capabilities also extend to contaminants of health concern. In addition to calcium and magnesium, they exchange and remove iron, barium, radium, lead, copper, and all the positively charged multivalent ions. In particular, radium is naturally present in many groundwaters in excess of the MCL. ANSI=NSF Standard 44 has protocols for testing softeners for their ability to reduce barium and radium along with hardness. Other POE products available for lowering concentrations of health-related contaminants are anion-exchange units. These units have been used for the reduction of nitrates=nitrites from source water in rural homes with private wells. They are also being used for reducing arsenic levels in such waters. Similarly, new units using activated alumina or similar media are being used for removing arsenic in rural areas. These types of units are often designed and sized to the site-specific application to achieve the end results needed in that location. They are rarely tested and certified by third-party organizations because of their need to be proved with the unique local conditions.

16.7

SELECTING POU AND POE TECHNOLOGIES

The following factors should be considered when deciding on the type of treatment to be used in a community:

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 The contaminant(s) to be removed  Untreated water quality characteristics such as pH, hardness, co-occurring contaminants  Treated-water quality desired  Operational requirements of the treatment technology (e.g., backwashing, pretreatment, etc.)  Operator technical skill required  Waste disposal requirements  Applicable local, state, and federal regulations

Important considerations in the selection of POU and POE technologies are introduced below. Readers interested in using water systems applying POU or POE technologies should refer to USEPA (2002b) guidance for additional tips.

16.7.1

Pilot Testing

Imprecise selection POU or POE treatment technologies may result in costly retrofits. To ensure success, each POU or POE technology being considered, even if tested and certified by an independent organization, should be extensively pilottested. Thorough pilot testing prior to installation measures how well technologies perform under local conditions (temperature, humidity, raw water characteristics, etc.) that may vary location to location and on a seasonal basis. POU and POE vendors and manufacturers may pay for all or part of the necessary pilot testing as part of the cost of doing business (cost of sale). Therefore, water systems should attempt to negotiate with vendors to help support the cost of pilot testing. At a minimum, pilot testing should identify the need for pre- and=or posttreatment. Also, maintenance and sampling schedules should be established on the basis of average and minimum run lengths, with a margin of safety applied. In estimating costs, USEPA used a 100% margin of safety when determining appropriate maintenance and replacement schedules for POU and POE treatment units. This safety factor allows for variations in annual household consumption and water use and potential variations in source water quality. ANSI=NSF standards allow units equipped with automatic warning devices to maintain a safety factor of 20 percent. Several treatment technologies may be needed in a single POU or POE treatment system to address certain water quality problems. For example, prefiltration greatly extends RO membrane life, whereas a postfiltration activated carbon filter improves the aesthetics of treated water, resulting in improved customer satisfaction. If possible, pilot testing should be conducted to evaluate treatment efficacy covering seasonal variations in water quality. If extended testing is not feasible or is too expensive, a test period covering at least 2 consecutive accelerated product life cycles is recommended to ensure consistent removal of the contaminant of concern.

16.7 SELECTING POU AND POE TECHNOLOGIES

16.7.2

419

Certification

As discussed previously, if an ANSI=NSF product standard has been established for a treatment technology, any POU or POE unit that relies on that technology must be certified to that standard if it is installed for SDWA compliance. Only products that have been independently certified by an accredited laboratory to the applicable ANSI=NSF standard may be used.

16.7.3

State and Local Regulations

State regulations may restrict implementation of centrally managed POU or POE treatment. Currently, some states do not allow the use of POU units for SDWA compliance. However, most states do at least allow their use as a condition for obtaining a variance or an exemption to a NPDWR, while others are reconsidering POU and POE policies in light of the significant cost advantages. Most states also allow use of POE treatment devices to achieve SDWA compliance or as a condition for obtaining a variance or an exemption. Those considering in-home treatment options for public water systems should contact the state drinking water primacy agency to confirm the position of the state on the use of POU or POE treatment devices for compliance with a MCL. Local regulations must also be considered and may present a barrier. For example, water system staff may not have the legal authority to enter private dwellings. As a result, the local government may need to pass an ordinance ensuring staff access to POU and POE treatment units to conduct maintenance and sampling activities. Alternatively, the water system could require all homeowners in the service community to sign agreements explicitly providing water system staff with access to their homes for the purpose of conducting necessary maintenance and sampling activities. This is being studied (2003) by states and USEPA and may lead to definitive approaches in the near future. The states of California, Iowa, and Wisconsin have POU=POE certification programs already in place. The community should check with the state to verify whether a specific POU=POE unit has been certified for the reduction of the specific contaminant by the state’s product certification program. In addition, the water system must comply with all local plumbing, electrical, and=or building codes. Consulting with local health or licensing authorities is necessary during the development of the POU or POE management plan to ensure approval of the installation, maintenance, and monitoring strategies. Local codes may require that personnel involved in the installation, repair, and=or maintenance of POU and POE treatment units be certified as licensed plumbers and=or electricians. This requirement could significantly increase costs. In general, equipment vendors are knowledgeable in the manner in which local regulations impact the operation of POU and POE treatment devices, and these potential difficulties should be discussed with the vendor prior to equipment purchase.

420

16.7.4

SDWA COMPLIANCE USING POU AND POE TREATMENT

Negotiating Initial Costs

Volume discounts may apply to the initial cost of the POE or POU units. The quality and reliability of POU and POE treatment devices have improved rapidly, while costs of have decreased. But seeking competitive bids is still recommended as prices may vary markedly for a particular technology. Leveraging buying power to negotiate volume discounts with manufacturers and=or retailers may be possible. Alternatively, a water system may elect to contract with a vendor to rent POU or POE treatment devices. This approach eliminates up-front capital costs and ensures availability of trained maintenance personnel. The lowest bid will not necessarily be the cheapest option in the long run. Several vendors should be contacted when seeking to purchase POU or POE units and references should be requested from each. Past performance in other communities can provide insight into the level of service that can be expected, and may identify potential problems before a binding contract is signed. Information should be obtained regarding product warranties and the availability of replacement parts. 16.7.5

Operation and Maintenance

Most of the cost of centrally managed POU or POE treatment is due to operation and maintenance (O & M). Treatment units should be selected that will be easy to service and sample. Vendors will provide turn-key contract maintenance and servicing, or alternatively will typically provide training for maintenance staff. The WQA provides Certified Water Specialist, Certified Installer, and Certified Contractural Operator for very small systems education and certification programs for members of the POU and POE industry. 16.7.6

Residuals and Waste Disposal

Waste disposal will result from virtually every type of POU or POE technology. Spent cartridges, media, membranes, bulbs, and filters must all be disposed of at the end of their useful life. In addition, waste brines from the use of POU and POE RO systems and POE ion-exchange systems, and backwash water from POE AA (activated alumina), GAC, and other filtration systems require disposal. Prior to selecting a treatment technology, potential difficulties associated with the disposal of these wastes should be considered. USEPA has developed guidance (USEPA 2000a) to assist in characterizing waste streams. Strategies for waste disposal are discussed in Section 16.10.6.

16.8

INSTALLATION AND MAINTENANCE

POE and POU unit installation can be complicated and time-consuming, particularly for POE devices. Improper installation can lead to unit malfunction, a decrease in the unit’s effective life, property damage, and difficulties with maintenance and

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421

sampling. Developing a standardized installation protocol is important to reduce the chance of interhousehold variability in unit performance. Regular access to all treatment devices is necessary after installation to provide maintenance and conduct routine sampling. To minimize the need for coordination with homeowners, installing POE units outdoors provides an advantage, whenever possible. In colder regions, where temperatures drop below freezing even for part of the year, installing POE units inside is necessary to prevent damage. In most regions of the United States, the best available site for unit installation will be either a garage or basement. POU units typically are installed under the kitchen sink to ensure treatment of all water used for drinking and cooking, and to protect the unit from damage and tampering. Basement installation of POU units may be possible in some areas depending on household layout. Units must be installed in a manner that permits service access quickly and easily. In warmer regions, the unit might be installed outside of the home (e.g., small shed). Garage or basement installations, particularly for POE devices, may also improve access to the unit without disrupting customer schedules. Installing a unit bypass greatly eases the process of replacing treatment media or the unit itself when necessary. Sampling taps installed before and after the treatment unit will allow samples to be obtained quickly and easily. Valves should be provided to isolate individual units as necessary. The manufacturer must be consulted to ensure that the installation plan will not hamper unit operation. For example, for most efficient operation, UV disinfection elements must be plumbed so that they are preceded and followed by straight lengths of pipe (i.e., no bends) measuring approximately 6 pipe diameters and at least 4 pipe diameters, respectively (e.g., a system plumbed into a 14-in. line would require 1.5 in. of straight piping prior to the UV lamp and 1 in. of straight piping after the lamp for optimal operation). State or local laws may require treatment units to be installed by a certified installer, a licensed plumber, or even a professional engineer. An electrician may be required to supervise the installation of units that require large amounts of power (e.g., aeration and distillation units). POU and POE treatment units require regular maintenance to ensure ongoing effective operation. Inadequate maintenance will cause the unit performance to deteriorate. The effective unit capacity (i.e., total gallons treated to below the MCL) should be determined during pilot testing. This information should be used as the basis for the maintenance schedule. To ensure customer safety, an adequate safety factor should be built into the maintenance schedule. An aggressive maintenance schedule will also help prevent small problems (e.g., leaks) before they become major problems (e.g., damaged floors or burst pipes) and will build customer confidence. An example schedule detailing necessary maintenance activities over the course of a year is provided in the USEPA guidance (USEPA 2002b). The following factors should be considered when developing a maintenance plan for POU and POE units:  Location of the Unit. As discussed above, a unit that is difficult to reach or examine takes longer to inspect and service than one in a relatively open area.

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SDWA COMPLIANCE USING POU AND POE TREATMENT

Consider maintenance requirements prior to installation. In the long run this will save time, reduce frustration, and lead to lower overall costs.  Coordination with Sampling. If possible, sampling should be conducted after completing routine maintenance (on the same visit). Keep house visits to a minimum. This will lower administrative costs, reduce travel time, yield cost savings, and minimize disruption to residents.  Adjustment of Maintenance Schedule on the Basis of System Experience. For example, some households served by the system may have relatively higher sediment loads, necessitating more frequent prefilter replacement.

16.9

MONITORING

Monitoring both the quality of water being distributed to the community and the quality of finished water produced by the POU or POE treatment units is important. In addition to sampling activities at a well or central treatment plant, post unit samples should be taken from each household within the community when POU or POE treatment is first implemented. This ensures complete coverage and will quickly identify any units that are not providing an adequate level of protection. Assuming that treatment units have reduced the concentration of the contaminant of concern to below the MCL, USEPA (2002b) is considering allowing reduction of the frequency of sampling to once every 4 years. In this case, one-fourth (25%) of all units would be sampled each year for chronic contaminants on a rotating basis. For acute contaminants such as nitrate, each POE unit should be sampled more frequently. Under reduced monitoring schedules, POU and POE performance data may be augmented through the use of commercially available field test kits, electrical conductivity meters (appropriate for evaluation of RO operation), and water hardness testing (to evaluate the effectiveness of cation exchange in removing radium and barium). These techniques can be used to quickly and inexpensively spot-check water quality on site during routine maintenance visits. Extensive use of validated test kits in these houses may provide good cost reductions because of the lower analytical costs. However, a minimum number of samples must be analyzed using a qualified laboratory similar to water systems using central treatment. A unit’s location will affect ease of sampling. Installation of sampling taps accelerates the sampling process, particularly for POE units. POU and POE sampling should be coordinated with routine maintenance and previously required on-site sampling such as monthly coliform sampling and annual sampling for copper and lead.

16.10

IMPLEMENTATION ISSUES AND STRATEGIES

A water system will likely face several barriers in the process of implementing centrally managed POU or POE treatment. These include public relations, admini-

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423

stration, training and operator certification, liability, equipment failure, and waste disposal issues.

16.10.1

Public Relations

Customers need to be kept informed of current and future activities that will impact service. In addition, water systems must respond to customer complaints, ensure customer satisfaction, and maintain customer support for use of POE or POU technology. Because units are installed and maintained on customer property, frequent interaction with homeowners may be necessary. Water systems should attempt to educate the public prior to implementing a POU or POE compliance program. Customers need to know (1) why the water system elected to install POU or POE devices (e.g., greater protection at lower cost), (2) the level of performance expected, (3) when and how customers should contact the water system (or contract service) if there is a problem, (4) their responsibilities (e.g., protecting their unit from damage or tampering), and most importantly, (5) why they must use the treated water from the separate POU tap for their drinking water safety and the public water system’s compliance. Communications may take the form of house visits, telephone calls, a town meeting, announcements in the local newspaper, and informational pamphlets (perhaps included with the water bill). Unanticipated problems should be expected, especially when devices are first installed. Water availability is crucial, and repair staff should be on call at all times. Timely responses ensure customer safety and may help prevent costly repairs in the future. A customer complaint telephone number can provide a means for quick responses to customer concerns. Customers need to ensure that water system personnel and any contract service employees are knowledgeable and trustworthy. Maintaining customer confidence is especially important because treatment takes place in customers’ homes. The small details of customer service—arriving promptly for appointments, remaining courteous at all times, answering customer questions, and cleaning up after performing sampling or maintenance—are critical for gaining customer confidence.

16.10.2

Administration

Administrative tasks can be time-consuming. These include customer outreach, scheduling, and recordkeeping. Additional employees, even if only part-time, may be needed to develop schedules for installation, maintenance, and sampling; to set up and confirm appointments; and keeping records up-to-date. Most people will gladly allow the water system access to install POU or POE treatment units and to conduct the necessary maintenance and monitoring to ensure their ongoing effectiveness. However, an individual or two may resist providing water system personnel with the necessary access. Therefore, the water system or local government should draft an ordinance requiring homeowners to provide access or risk having service terminated. USEPA (2002b) has developed a sample access

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agreement and a sample ordinance that can be modified and used by a water system to provide the legal right to conduct necessary maintenance and sampling activities. 16.10.3

Operator Training and Certification

Training is important to successful implementation of a POU or POE treatment strategy. Many vendors offer training in the proper operation and maintenance of their equipment as part of their sales package. Arrangements can also be made for equipment vendors to install and maintain the devices, in which case additional training is unnecessary. Alternatively, the vendor may be relied on to maintain the units for a period following their initial installation while system personnel are trained. State regulatory agencies may require water system operators and other system personnel to participate in formal training programs or obtain additional certification. Training programs by states or other organizations specifically for the operation, maintenance, and administration of POU and POE treatment better equips personnel. As the use of POU and POE treatment devices becomes more prevalent, state and local technical assistance providers will offer more training programs specifically targeting those individuals who install, maintain, and operate these devices. Nongovernmental groups such as the NSF and the WQA offer training programs in the use and operation of POU and POE treatment units. The WQA has an established program to certify the qualified individuals that can pass requirements in water quality, chemistry, and POU=POE treatment technologies. Equipment manufacturers frequently offer training programs to vendors. Either the manufacturer or the WQA can be approached for a program of training and certification of the operators. 16.10.4

Liability

Under the SDWA, the water system is responsible for maintaining the safety of the water provided. In addition, the water system is directly responsible for the operation and maintenance of all POU and POE treatment devices installed as part of an SDWA compliance strategy. Therefore, the water system will be liable in the event of device malfunction or failure. The water system is also obligated to test and maintain these devices and to educate consumers about their responsibility to contact the system if a problem arises. High liability costs are unlikely as long as proper maintenance and monitoring is performed and the water system staff approach their duties in a professional manner. Liability and risk can be reduced by negotiating certain contract provisions with the vendor selling the treatment equipment or with a subcontractor hired to conduct sampling and=or maintenance to insulate the water system (at least in part) from the consequences of device failure. Water systems should negotiate with the vendor or installer for them to retain responsibility for all units for a specified period after installation to allow for minor adjustments, leak repair, and a follow-up inspection. Also, water systems may purchase additional insurance (e.g., comprehensive general

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425

liability insurance) from an outside provider (e.g., State Farm). Liability insurance may be acquired to cover homeowner damages resulting from malfunctioning units. Contract and insurance law are extremely complex and obtaining legal assistance is recommended when deciding on actions to take to reduce liability. 16.10.5

Equipment Reliability

POU and POE equipment must perform reliably to ensure SDWA compliance. Prepare for equipment failure by stocking replacement units and parts. Ongoing parts availability should be considered when selecting an equipment supplier. To minimize storage costs, negotiate with equipment vendors to provide all replacement parts on demand at or below retail cost. When purchasing equipment and service contracts, confirm through reference checks that the potential supplier is reliable and trustworthy. A good vendor should be easy to contact and should provide technical assistance in the event a problem occurs. 16.10.6

Waste Disposal

Nonhazardous solid waste produced by these treatment systems can usually be disposed of like normal household waste, delivered to a local landfill or regenerated and recycled. Nonhazardous liquid waste may usually be discharged to publicly owned treatment works (POTWs), on-site septic systems, or dry wells. In these cases, the disposal costs associated with the POU or POE treatment strategy are likely to be negligible compared to the cost of equipment, installation, and ongoing operation and maintenance. Many systems have implemented POU and POE treatment strategies with no waste disposal problems. Waste containing high concentrations of certain contaminants may require special handling and disposal, which can be costly. The media used in POE devices for treating radionuclides such as radon, radium, or uranium may require handling and disposal as a radioactive waste when replaced. Similarly, wastes that fail the toxicity characteristic leaching potential (TCLP) test may require treatment (disposal) as hazardous waste. Some wastes may have to be tested to verify TLCP characteristics. Extensive experience in private home water treatment for all SWDA contaminants as currently practiced throughout the United States suggests that in POU and POE applications, treatment media should not be expected to build up any contaminants to levels requiring hazardous radioactivity or TCLP handling and disposal procedures. In addition, California has a special test for disposing spent material, and communities in California should request the manufacturer and the state to make sure that the product can be disposed of without undue handling problems. Solid residuals generated by POU and POE units are collected from individual households. Therefore, these wastes may be exempt from federal regulation as hazardous wastes, regardless of their toxicity. However, state regulations and each state’s implementation of federal regulations will differ. In the case of liquid wastes, local wastewater treatment plants may issue their own limits for the disposal of certain contaminants, such as copper and TDS. POU and POE devices seldom

426

SDWA COMPLIANCE USING POU AND POE TREATMENT

have waste disposal problems. However, to avoid issues with the disposal of wastes from devices, local wastewater treatment plant as well as state regulatory authorities should be consulted to clarify the interpretation of hazardous-waste regulations prior to implementation of POU or POE treatment. 16.10.7

Economics and Cost Estimating

The economic attractiveness of POU and POE for SDWA compliance will be sitespecific. Water systems must also ensure sufficient water supply for fire protection and other essential uses, even if this water is treated to a lesser degree. The economic cost of POU and POE is sensitive to several factors, and care must be given to use appropriate assumptions when assessing the feasibility of POU and POE for a particular water system. For example, in estimating the cost of POU and POE for arsenic removal in small systems using AA and RO, USEPA (1999b) applied the following assumptions:  Average household occupancy of 3 persons, 1 gallon drinking water each per day, or 1095 gallons per year  Annual volume treated of 1095 gallons for POU, or 109,500 gallons if POE used  Cost for minimally skilled labor of $14.50 per hour (population <3300 persons)  Cost for skilled labor of $28.00 per hour (population >3300 persons)  Treatment unit life of 5 years for POU and 10 years for POE  Duration of application for cost estimation of 10 years (i.e., 2 POU units)  Cost of water flow meter and automatic shutoff value included  No shipping and handling costs  Volume discount for simple unit at 10% discount for 10 or more units, 15% discount for more than 100 units  Installation time of 1 hour unskilled labor for POU, and 3 hours skilled labor for POE  O & M costs including maintenance, replacement of prefilters, membrane cartridges, or AA cartridge, laboratory sampling, analysis, and administrative costs USEPA’s annualized cost estimates for communities below 1000 persons range from about $250 to over $300 per unit per year. Gurian and Small (2002) developed a base case scenario for removal of arsenic using RO, along with high-cost and low-cost options. Their base case was as follows:  Three-stage treatment using a cellulose acetate–triacetate membrane: $230 per unit  Annual prefilter replacement: $29 per year

16.11 FUTURE OUTLOOK AND TRENDS

     

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Membrane replacement every 2 years: $75 per membrane Labor at $100 for installation: $50 per year annual service Nonscheduled service: $100 in parts and $50 labor year 10 Consumer communication: $25 per year Monitoring one-third of units annually: $8.25 per year per unit Total annualized cost at 7% interest: $189 per unit per year

Their high-cost scenario was $506 per unit and utilizes a more expensive RO membrane, quarterly service calls, and quarterly monitoring. Their low-cost scenario was $151 and assumes that half of the customers would service their own units. This may be technically feasible, but is usually unacceptable to regulatory agencies. In the examples described above, annual cost estimates are sensitive to the assumptions applied. For example, the volume of water necessary to treat in the case of POU may in fact be less than 1 gallon of drinking water each day per person for a community. USEPA (2000b) determined that the mean daily average of estimated per capita community water is 927 mL per person. This estimate is influenced, however, by people ingesting either zero to very little amount of water or large volumes of water. Mean reported water consumption from all sources is slightly greater than 1 L per person per day. Therefore, the annual usage per household is likely to range between 300 and 500 gallons per year. Monitoring costs will be a significant portion of the annual costs in any scenario. Reduced labor rates, changing annual monitoring to only one-quarter of the units per year, or using less expensive field test kits for most of the samples, could reduce annualized costs. In the case of arsenic removal, any scenario typically requires chlorination of the source water to convert arsenic(III) to arsenic(V), for the most efficient removal.

16.11

FUTURE OUTLOOK AND TRENDS

Water utilities will increasingly consider POU or POE devices as they plan for compliance with future drinking water regulations. USEPA’s arsenic rule implementation guidance discusses implementation issues associated with centrally managed POU treatment for arsenic rule compliance (USEPA 2002a). The agency is currently (2003) updating its 1998 study, Cost Evaluation of Small System Treatment Options: Point-of-Use and Point-of Entry Treatment Units, which will also include updated waste disposal costs. As mentioned above, the conventional water utility approach is to perform all water treatment at a central plant and distribute treated water through a distribution system. Many customers, however, prefer to purchase bottled water—at significantly higher cost—because of taste, aesthetic, and perceived health advantages. Still other customers have voluntarily installed POU or POE devices to enhance the quality of conventionally produced water. The AWWA Research Foundation (AWWARF) and the California Urban Water Agencies (CUWA) are currently (2003) funding a project

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to examine alternative approaches for providing drinking water and protecting public health, including POU and POE treatment. In a unique venture, three Connecticut companies that provide public drinking water joined together to offer an array of products and services that customers have traditionally looked for elsewhere (BHC=RWA=CWC 1998). The venture, Check with the Source, was initiated jointly in June 1998 by Bridgeport-based BHC Company, Regional Water Authority in New Haven, and Connecticut Water Company in Clinton. Surveys by these companies showed that some people already use or would consider using a home water filter to control taste or smell and they would prefer buying the product from their water company. Some people are particularly sensitive to the taste or smell of chlorine. In addition to several other consumer products, Check with the Source offered for sale to customers water filters for those who are sensitive to chlorine taste. Recently, the Check with the Source program was discontinued because of a lack of consumer participation. The San Jose Water Company in California and Kinetico Incorporated, a POU and POE manufacturer, launched a program in 1999 through a newly formed joint venture company called Crystal Choice Water Service. This new company offered to customers of the San Hose Water Company Public Water system an opportunity to rent or purchase a home water treatement system consisting of a whole-house chlorine removal unit, a whole-house water softner, and an under-the-sink POU reverse osmosis system. This venture is operating successfully and sending the customers an enhanced water supply and drinking water quality choice. Although not an SDWA compliance strategy, customer service programs such as Check with Source and Crystal Choice could easily be adapted to address compliance-related water quality issues.

REFERENCES BHC=RWA=CWC. 1998. Press release: Water companies form unique alliance to offer wide range of products, services (June 10). Trumbull, CT: BHC Company. Dufour, A. P. 1988. Health studies of aerobic heterotrophic bacteria colonizing granular activated carbon systems. Proc. Conf. on Point-of-Use Treatment of Drinking Water. EPA=600=9-88=012. Cincinnati (Oct. 6–8, 1987). Gurian, P. L. and M. J. Small. 2002. Point-of-use treatment and the revised arsenic MCL. J. Am. Water Works Assoc. 94(3):101–108. Lykins, B. W., Jr., R. M. Clark, and J. A. Goodrich. 1992. Point-of-Use=Point-of-Entry for Drinking Water Treatment. Boca Raton, FL: Lewis Publishers. Payment, P., E. Franco, L. Richardson, and J. Siemiatycki. 1991. Gastrointestinal health effects associated with the consumption of drinking water produced by point-of-use domestic reverse-osmosis. Appl. Environ. Microbiol. 57:945–948. Snyder, J. W., C. N. Mains, R. E. Anderson, and G. K. Bissonnette. 1995. Effect of point-of-use, activated carbon filters on the bacteriological quality of rural groundwater suppliers. Appl. Environ. Microbiol. 61:4291–4295.

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USEPA. 1998a. Removal of the Prohibition on the Use of Point-of-Use Devices for Compliance with National Primary Drinking Water Regulations. Fed. Reg. 63:31932–31934. USEPA. 1998b. Cost Evaluation of Small System Compliance Options: Point-of-Use and Point-of-Entry Treatment Units. Washington, DC: Office of Water. USEPA. 1999a. Water Supply Guidance H53. Point-of-Entry (POE) Devices to Comply with the Total Coliform Rule, Surface Water Treatment Rule (SWTR) and Interim Enhanced Surface Water Treatment Rule (IESWTR). Washington, DC: Office of Ground Water and Drinking Water. USEPA. 1999b. Small Systems Compliance Technology List for the Arsenic Rule. EPA-815-R-00-011. Washington, DC: Office of Ground Water and Drinking Water. USEPA. 2000a. Waste Disposal Costs for Point-of-Use and Point-of-Entry Treatment Strategies. Washington, DC: Office of Water. USEPA. 2000b. Estimated per Capita Water Ingestion in the United States. EPA-822-R-00008. Washington, DC: Office of Water. USEPA. 2002. Implementation Guide for the Arsenic Rule. Draft. EPA-816-D-02-005. Washington, DC: Office of Ground Water and Drinking Water. USEPA. In press. Guidance for Implementing a Point-of-Use or Point-of-Entry Treatment Strategy for Compliance with the Safe Drinking Water Act. Washington, DC: Office of Water. World Health Organization (WHO). 2002. Heterotrophic Plate Count Measurement in Drinking Water Safety Management, Report of an Expert Meeting, Geneva, Switzerland, April 24–25.

PART IV COMPLIANCE CHANGES

Drinking Water Regulation and Health, Edited by Frederick W. Pontius. ISBN 0-471-41554-5 # 2003 John Wiley & Sons, Inc.

17 DEATH OF THE SILENT SERVICE: MEETING CUSTOMER EXPECTATIONS ELISA M. SPERANZA Vice President, CH2M Hill, New Orleans, Louisiana

17.1

INTRODUCTION

For many years, the water supply profession prided itself on performing ‘‘the silent service.’’ Utilities were content to be taken for granted by the public they served. Since the late 1960s, however, public awareness of environmental issues, instantaneous media coverage of events, and the increasing cost of supplying safe drinking water all mean that utilities must be increasingly accountable to the public they serve. This chapter explores the underpinnings of customer service: who utility customers are, how they get their information, who they believe, what they think, what they want from utilities, and how to get it to them.

17.2

WHO ARE WATER UTILITY CUSTOMERS?

Before trying to understand what customers want, it is important to understand who they are. In short they are everyone. The demographic makeup of a utility’s service area reflects a broad array of ages, ethnic backgrounds, lifestyles, and health issues. The more important issue is who will the customers be in the near future. Analysis of Drinking Water Regulation and Health, Edited by Frederick W. Pontius. ISBN 0-471-41554-5 # 2003 John Wiley & Sons, Inc.

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Figure 17.1 U.S. life expectancy.

the most recent U.S. Census data and other demographic data have revealed trends important to water utilities (RAND 2000).
Life expectancy will continue to increase, meaning an increase in the number of older people, who are more sensitive to drinking water contaminants. For example, the life expectancy of a woman born in 1940 was 65.2 years; in 1996, 79.1 years; a man, from 60.8 years to 73.1 years.
Ethnic composition will change, impacting how information is disseminated. Many immigrants will also bring attitudes about tapwater with them from their native lands. For example, most of the expected population growth will be Hispanic. Projected population changes from 1995 to 2025 are white 16%, African-American 12%, Native American 1%, Asian 12%, and Hispanic 32%.
Income, even in the best of economic times, is disproportionately distributed— the rich get richer faster than the poor increase their income. Affordability will continue to be a factor for water utilities contemplating rate increases. For those with higher incomes, health issues will be an increasingly high priority. For example, the average income of the top 5% of households has grown from $132,000 to $222,000, while the bottom 20% has grown by only $344 from 1980 to 1998.
Education levels continue to rise, meaning that customers will be more likely to demand more and better information. (See Chart 2—US Census 2002).
Housing trends have seen an increase in higher density housing, where people use less water than in landscaped single-family homes. The percentage of housing units that are single family detached homes peaked in 1960 and has been declining ever since (although these trends vary in different parts of the country).
Technology, especially computer usage, is rising exponentially, greatly expanding access to information, commerce, and services. According to the U.S.

17.2 WHO ARE WATER UTILITY CUSTOMERS?

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Figure 17.2 Percentage of people 25 and over.

Department of Commerce, the percentage of the population using computers rose from 18% to 51% from 1993 to 2000, and continues to grow. (See Chart 3—US Census 2000).
Business customer demographics have changed as well, with the largest growth sector shifting to services, finance, insurance, and real estate, according to the U.S. Department of Commerce—much less water intensive than other sectors. From 1987 to 1997 growth in agriculture was 13%; manufacturing, 18%, finance, insurance, and real estate, 44%; and services, 60%. These trends indicate that water utilities accustomed to doing things because ‘‘that’s the way we’ve always done it’’ will be in for a rude awakening. Those who understand the dynamic nature of their customers, and adapt to meet their needs, will be more likely to succeed.

Figure 17.3 Percentage of U.S. households with computers and internet access.

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17.3

DEATH OF THE SILENT SERVICE: MEETING CUSTOMER EXPECTATIONS

PUBLIC WATER SUPPLIERS AS A MONOPOLY

While most public water suppliers enjoy a monopoly position in their service areas, increased competition from investor-owned utilities and private-sector contract operators—even from neighboring public agencies—has redefined the landscape for utilities since the early 1990s or so. In addition, customers are spending more of their discretionary income on bottled water and home treatment devices, further undermining confidence in public water supplies. Even though bottled water is 1000–5000 times more expensive than tapwater, bottled water sales continue to grow exponentially—by 10.1% from 1997 to 1998, according to the International Bottled Water Association (IBWA). Reasons cited for bottled water use vary according to different surveys. According to the IBWA, 56% of bottled water customers cite taste and 55% cite convenience as the strongest influence on their decision; 37% cite trust in bottled water treatment and 35% trust in the source (IBWA 2000). A survey by the Water Quality Association (WQA), a trade group representing the home treatment device industry, revealed that Americans using household water treatment devices increased from 27% in 1995 to 38% in 1999 and to 41% in 2000 (WQA 2001).

17.4

WHERE CUSTOMERS OBTAIN INFORMATION

Where do customers get information about their drinking water? People obtain news and information from a wide variety of sources, and audiences are diverse and fragmented. Using scientific information as a surrogate for the type of water quality information utilities would like to share with their customers, it is interesting to note the results of a survey by the National Science Foundation (NSF). The survey revealed that television is the leading source of information about new developments in science and technology, followed by books and newspapers. Each adult watches an average of about 1000 hours of television per year, approximately 42% of which is devoted to television news. The percentage of all adults, at all education levels, who read a newspaper every day has been declining—from 62% in 1983 to 41% in 1999 (NSF 1999). As an interesting sidelight, about three out of every five Americans visit a science museum, natural history museum, zoo, or aquarium at least once per year, which may suggest that water utilities might consider partnering with these types of institutes in developing public education programs. Internet usage is expanding exponentially. A biennial survey conducted by the Pew Research Center showed that the number of people who say they are getting news from the Internet has grown substantially. Almost 70% of Americans say they expect to find ‘‘reliable, up-to-date news on-line.’’ Science, health, finance, and technology were the biggest draws for people using the Internet as a supplement to other news sources. ‘‘As Americans grow more reliant on the Internet for news, they also have come to find online news outlets more credible,’’ Pew researchers found. (Pew Research Center 2002).

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A survey of journalists and scientists conducted by the Freedom Forum First Amendment Center (Hartz and Chappell 1997) revealed a striking lack of confidence in the press among scientists—only 11% of scientists reported having a great deal of confidence in the press, and 22% said that they have hardly any. Confidence in television media was even lower: nearly half of the scientists said that they have hardly any confidence in it. Scientists faulted the media for failing to understand the process of scientific investigation, oversimplifying complex issues, and focusing on trendy discoveries. These sentiments echo the complaints that many water utilities voice about their local news outlets. For their part, most news decisionmakers have little training in science, and many believe that their readers are either uninterested or unable to understand sciencerelated stories. Reporters surveyed faulted scientists for using technical jargon instead of plain English, and for being unable to succinctly summarize their research. They said that scientific information should be relevant and placed in context for it to be newsworthy. Water utilities would do well to place themselves in the shoes of a harried reporter, on deadline and cramped for space, when attempting to get information to the public. Environmental groups and health workers enjoy high credibility. In a widely circulated study of public attitudes toward drinking water, the National Environmental Education and Training Foundation (NEETF) found that one-third of the adult population says that it receives information on drinking water from environmental and other public interest groups, although 72% of the adult population claims to find information from these groups ‘‘very’’ (19%) or ‘‘mostly’’ (53%) believable. They are the top-ranked source (NEETF 1999). Physicians and healthcare providers follow closely behind—69% believe information from them, with 33% saying that they are ‘‘very’’ believable (the highestranked group in the ‘‘very’’ believable category). They were, however, the least likely to be a source of that information (14%). Not surprisingly, 65% say that media sources are ‘‘mostly believable,’’ and 61% get information there first. Only 17% state that water utilities are ‘‘very believable,’’ although 58% consider them ‘‘very’’ or ‘‘mostly’’ believable. Of those who boil, filter, or use bottled water, 46% are ‘‘very’’ concerned about the quality and safety of their tapwater because of their water company. The good news, however, is that 79% of those who currently receive information from their water supplier state that it’s ‘‘mostly’’ or ‘‘very’’ believable. If the public receives information from water suppliers, they have more confidence in the quality of their drinking water.

17.5

WHAT CUSTOMERS THINK AND WANT

What do customers think? What do they want? Understanding who customers are and where they get their information is an important step in achieving customer understanding. Many groups and utilities themselves have taken time to research customer attitudes and what types of information they want.

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According to the NEETF survey, Americans basically trust that their tapwater is safe and drinkable—75% drink water from the tap, and 91% cook with it. But 76% express some concern about the quality and safety of their water, with 38% reporting they are very concerned, if not necessarily worried. The survey indicated a growing tendency for people to filter tapwater and=or drink bottled water in the home. The main reasons given were taste, smell, or color, followed by news stories about water pollution and the convenience of bottled water. Disturbingly, 26% of Americans say that they do not know, even in general terms, where their water comes from. Researchers say this is a relatively high number of people to volunteer a ‘‘Don’t know’’ response in a multiple-choice question format. Parents with children at home are more concerned than nonparents about drinking water quality. Women have a higher level of concern about both tapwater and health in general. The bottled water drinkers are a younger group and have the highest expressed concern about safe drinking water, at 82%. According to a survey by the Rebuild America Coalition in 1999 (RAC 1999), only 13% of Americans believe that their drinking water quality has improved over the last five years; 25% think that it has gotten worse. Although there are variations by region and demographics, overall 74% would be willing to pay more in taxes to guarantee a safe and more efficient treatment system. These statistics are supported by the Water Quality Association 2000 survey, which showed that 86% of Americans have concerns about their water, with 66% citing aesthetics and 51% worried about contaminants. 17.5.1

Trust and Consumer Confidence

A New York City (NYC) study found a direct link between trust in the water utility and consumer confidence. Taking advantage of New York City’s investment in watershed protection in upstate New York as part of its approach to compliance with the Safe Drinking Water Act (SDWA), a team of researchers from Cornell University developed a study of public knowledge, attitudes and behavior toward the environment in samples of 1000 households in upstate communities and 1500 NYC residents. Differences in confidence in the water supply were directly related to ‘‘trust’’ in the NYC Department of Environmental Protection (DEP), the city’s public water supplier. The majority of those who lacked confidence rated NYC DEP’s performance as ‘‘fair’’ or ‘‘poor.’’ Those who lacked confidence in NYC DEP were also much more likely to think that federal water quality standards were ‘‘not strict enough,’’ and were more likely to drink bottled water only. Only about 30% of all New Yorkers drank only tapwater, compared with almost half of central city residents nationwide (Pfeffer and Stycos 2000). Among the study’s many other interesting findings, the researchers found that personal interactions with fellow community members regarding local environmental problems, or ‘‘cultural praxis’’ was the strongest individual level predictor or environmental knowledge. This argues for grass-roots stakeholder involvement programs as an important component of a utility’s communication program.

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In general, water quality eclipses water availability as a concern. In a public opinion survey about a wide range of environmental issues relative to global warming, researchers were brought up short in their questioning about water availability because the survey respondents were more concerned about water quality (Immerwahr 1999): There was a tremendous concern that drinking water may be contaminated with pollutants . . . the pollution of rivers, lakes and reservoirs tops the list of environmental concerns. Sixty-one percent say they worry a great deal about this topic, as opposed to only 40% who are concerned about damage to the earth’s ozone layer.

Interestingly, the survey found that, with the exception of southern California, survey respondents were less concerned about water availability because of the perception that vast amounts of ocean water could be desalinized and used for drinking water with the right technological solution. Even in Los Angeles, people were skeptical about the seriousness of water shortages and suspicious of information coming from the government. Americans form strong opinions regardless of knowledge. The NEETF’s most recent survey of environmental knowledge reached the encouraging conclusion that 95% of adult Americans believe environmental education should be taught in schools, and think that adults should have access to environmental education in the workplace. Widespread environmental illiteracy persists, and, ‘‘unfortunately, many Americans overestimate their knowledge of environmental issues and problems,’’ the survey concludes (NEETF 2001). The public still does not know the leading causes of water pollution, although they are concerned about it. They also repeatedly express a willingness to support government environmental protection programs. The majority of Americans state that environmental protection and economic development can go hand in hand—62% agreed with this option rather than choosing one over the other. But when pushed to chose, 71% chose the environment. While many Americans object to overreaching government intervention, 46% of Americans responding to the NEETF survey think that current environmental protection laws ‘‘do not go far enough,’’ while 32% think that they have ‘‘struck the right balance.’’ In the WQA survey, 49% said that federal laws are not strict enough, and 90% of parents (85% of the general population) have ‘‘concerns’’ about their water. These poll numbers start to explain why the Environmental Working Group so often chooses so-called women’s magazines as the targets of its reports on drinking water.

17.5.2

Customer Satisfaction Surveys

Customer satisfaction surveys can offer a water utility valuable information. Many utilities conduct regular customer satisfaction surveys to gauge their performance and obtain customer feedback. Aside from the more routine information gathered by

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these surveys, utilities often gain insights into the subtleties and diverse needs of their customer base. For example, one New England utility found that younger respondents and those earning $75,000 per year or more provided the lowest positive ratings when asked their level of trust in the utility. Those aged 55 and over provided the highest positive ratings. This information is valuable in designing public outreach programs targeted to specific audiences (CRPP 1997). Another utility—one known for its high-quality water and aggressive public outreach efforts—found that safety and quality of drinking water was rated most important to the customer—higher than taste and odor, water supply, or cost. There was concern about contamination of water, even as customers rated water quality as good and excellent overall, and trusted the utility to protect their water. Of the 28% of customers who described themselves as ‘‘greatly concerned,’’ 67% also rated the safety and quality of their water as ‘‘good’’ or ‘‘excellent’’ and another 20% rated it as ‘‘fair’’ (Denver Water 1997). Most respondents to this Western utility’s survey claimed that they do not receive much information about water quality but said that it was important. When asked for the best method of getting information to them, most listed the water bill insert (44%) with television second at 20% and newspapers at 12%. But only 22% of those who receive a bill insert say that they’ve read it. This statistic is confirmed by other surveys—the WQA found only 17% of respondents had read their city’s water quality report. Asked about bottled water usage, 12% of people in the utility’s service area reported that they drank bottled water often or always, mostly because they believed tapwater was unhealthy. Over 60% of those drinking bottled water often were females between the ages of 35 and 54; 17% reported having water filters because they do not believe that their water is adequately filtered and that their filter will improve taste and odor. New customers—those who have moved to the service area from other parts of the country—were most likely to question their drinking water. Everyone is somebody’s customer. Of course, in addition to this deeper understanding of customer concerns, satisfaction surveys also elicit feedback on standard utility business services with customer interfaces, such as meter reading, billing, collections, service on=off, field services, and complaints. What do customers want from their water utility in these areas? The same things we all want from our dealings with companies that provide services to us: prompt, courteous, knowledgeable responses and a speedy resolution to our problems. Customer service experts in the business world know that ‘‘human interactions drive feedback moments and companies need to capitalize on these moments to build positive word-of-mouth behavior’’ (PF 2001). Until utilities put customers at the center of their operations, customer service will be an afterthought, instead of the focus it should be. Such a shift requires a fairly dramatic change for most utilities. In Pinellas County, Florida, for example, the utility set out to develop an ‘‘advocacy’’ relationship with its customers, built around a thorough understanding of customer needs and expectations. After conducting focus groups and surveys, the Pinellas County Utilities (PCU) reorganized itself around customer drivers, rather

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than operational or compliance requirements. The PCU redesigned customer outreach forms and automated some customer service functions to take advantage of every possible opportunity for customer feedback (Wiley and Chelikowsky 2001). Rubin (1996) has attempted to summarize in an acronym what customers want: SPAM. This stands for ‘‘safety,’’ ‘‘participation,’’ ‘‘affordability,’’ and ‘‘management.’’ On the basis of the results of a 1993 AWWARF study Consumer Attitude Survey on Water Quality Issues (AWWARF 1993), and his own experience, Rubin (1996) argues that ‘‘safety is far and away the most important thing to water customers . . . protecting public health is the job of the water utility and its regulators.’’ Rubin has noted that the AWWARF 1993 study found a startling disconnect between what utilities thought their customers wanted and what customers really wanted. The overwhelming majority of customers wanted more input into major water utility decisions, but the overwhelming majority of utility managers thought that customers would say things were just fine the way they were. Although things have hopefully improved since that 1993 survey, still, ‘‘water customers want assurances that their utilities are professionally managed, with a focus on the customer. It’s that consumer orientation that gives the customer confidence that their water is safe to drink, that smart decisions are being made and that costs are being controlled’’ (Rubin 1996).

17.6

GAINING CUSTOMER SUPPORT

Customers will support water utilities seeking to improve their systems. The Rebuild America Coalition Infrastructure Survey reported in January 1999 (RAC 1999) that of all the categories of infrastructure about which the public was asked, water beat out all other categories for public support—higher than schools, streets, airports, and many other areas. This support held across demographic and even political party lines. When asked whether they would be willing to pay 1% more in taxes if it meant guaranteeing a safe and efficient sewage and water treatment system, 74% said that they were ‘‘very=somewhat willing,’’ and only 21% said they were ‘‘very=somewhat unwilling.’’ Two amusing yet disturbing water-related sidelights are mentioned here. When asked whether they would rather drink city tapwater or cough syrup, 70% said water, but 24% said that they’d rather drink the cough syrup. And nearly one-third of all Americans would rather take a swim in water from their own toilet bowl (37%) than from the nearest river (57%).

17.7

COMMUNICATING WITH CUSTOMERS

So, what’s a water utility manager to do? Maintain a constant dialog with customers, reach out to specific stakeholders, share all information, and educate the consumer. As a local clothing store in Boston says, ‘‘an educated consumer is our best customer.’’ Tell the truth. Sounds easy, but of course it’s not.

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17.7.1

DEATH OF THE SILENT SERVICE: MEETING CUSTOMER EXPECTATIONS

Communicating Risk

Survey after survey tells us that customers want to know, above all, whether the water is safe to drink. Answering the question ‘‘Is it safe?’’ with ‘‘Absolutely’’ is the biggest temptation water suppliers face. But is it? Safe for everyone? All the time? In all parts of the distribution system? In 1993, the outbreak of cryptosporidiosis (crypto) from a waterborne source in Milwaukee, Wisconsin served as a wakeup call to drinking water utilities. From a public health perspective, the Milwaukee crypto outbreak and other subsequent incidences of waterborne disease in North America have become even more significant because of the increasing number of immunocompromised people. In addition to HIV=AIDS patients, compromised immune systems can extend to cancer and organ transplant patients, the elderly, infants and toddlers, and pregnant women— in short, anyone could be immunocompromised at some stage of his or her life. ‘‘Science proceeds slowly,’’ says Ellen Ruppel Shell, co-director of Boston University’s program in science journalism: Scientists make mistakes. But there is a hue and cry from the public for information, and stories that normally wouldn’t be there are pushed to the front page very quickly. The effect of all this, is that the public becomes cynical about health and safety reports—the ‘‘cry wolf’’ syndrome.

Gerald Goldhaber, a professor of communications at the State University of New York at Buffalo, states ‘‘If you warn about everything, you warn about nothing . . . we are creating a cynical public that is less likely to pay attention to a real warning when it is really needed.’’ Sheldon Krimsky, professor of urban and environmental policy at Tufts University, comments ‘‘People find an equilibrium. When they are barraged with warnings, they select those that are meaningful to them’’ (Yemma 1996). Consumers are, understandably, very sensitive to issues impacting both their health and budgets. Many utilities have had the experience of trying to compare the cost of water to that of cable TV in an attempt to show what a bargain tapwater is—only to have that logical presentation of the facts backfire. ‘‘We choose to have cable TV,’’ the customer says, ‘‘We can’t choose our water provider.’’ Similarly, comparing the health risks of drinking tapwater and such personal choices as smoking or even drinking soda are rarely successful risk communication approaches. The drinking water community rallied in the 1990s to improve the state of our collective knowledge about crypto and health effects, other waterborne pathogens, and disinfection byproducts. Explaining the risks of these and other contaminants to the public, however, is difficult. One approach that has met with success is the building of alliances between water utilities and local public health officials. In many communities water and health officials have worked together to develop emergency action plans in case of an outbreak of waterborne disease. In the wake of the terrorist attacks on September 11, 2001, these same networks are being called on to maintain readiness in case of an assault on the public water system. These

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alliances are critical, both to operational response and to communication with the public—both in case of an incident and on an ongoing basis. A preeminent expert on risk communication, Dr. Peter Sandman, notes that ‘‘when people are outraged, they tend to think the hazard is more serious than it is. Trying to convince them that it’s not is unlikely to do much good until you reduce the outrage’’ (Sandman 1996). Recommended ways of doing this include being open, honest, and accountable and sharing control with the public. Noted risk communication expert Jim Hyde of Tufts University Medical School talks about a formula: Risk ¼ Actual Risk Level þ Perception. He reminds water utility and other audiences that they must preserve their credibility at all costs by:






Knowing their audience Telling people what they’re doing to manage the problem Admitting when they don’t know something and getting the answer Showing compassion and empathy for people’s fears Admitting mistakes (Hyde 2001).

17.7.2

Consumer Confidence Reports

Consumer Confidence Reports are an important communication tool. One of the most noteworthy amendments to the SDWA in 1996 was the requirement that all public water suppliers report to their customers on an annual basis about the quality of their drinking water. The passage of the ‘‘Consumer Confidence Report’’ (CCR) requirement presented an opportunity to satisfy customers’ need for information about water quality, so they can make informed decisions about their own health and the health of their families. CCRs are an opportunity to:







Respond to customers’ need for information Advance understanding of issues Enlist customers in source protection efforts Communicate utility’s message Build partnerships with stakeholders Form the centerpiece of a communication program

Focus groups to provide input into the development of the CCR rule revealed some key findings about customer attitudes toward water quality information (AWWA= Hurd 1998). Among the drivers of customer reaction to CCRs were
Format, style, and content of the reports clearly made a difference in customer attention and understanding.
People who trusted their local water utility were more receptive to the information and more confident in the safety of their drinking water.

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Water quality aesthetics played an important role in shaping perceptions of safety and trust.
There was little relationship between compliance and public confidence. Customers in the focus groups were fairly sophisticated in their needs and priorities. The single most important question they wanted answered is the one most difficult for utilities to answer directly and honestly: ‘‘Is the water safe to drink?’’ They made a distinction between ‘‘meeting federal standards’’ and ‘‘being safe’’ in that some people suspect that the federal standards may not be strict enough, which is supported by survey research. Most people wanted simple, clear statements, although some wanted more detail and evidence. Knowing that more information was available and how to get it was important (AWWA=Hurd 1998). Although these conclusions are generally replicated across the U.S. population, regional and demographic differences do impact public perception. Target audiences for communication material should be surveyed and opinions measured whenever possible. The following consumer questions the water quality report should be answered if possible:
Does the water meet all applicable standards? (This is a different question from ‘‘Is the water safe?’’)
How do the results affect me?
If there’s a problem, what is the water utility doing about it? The heart and soul of the CCR is the ‘‘detected contaminants table.’’ Some utilities have attempted to include in this table all the things they tested for and did not find. The rule does not allow this practice, for good reason. Focus group research conducted by the American Water Works Association (AWWA) and the U.S. Environmental Protection Agency (USEPA) conclusively showed that the average person, when confronted with a table full of numbers, quickly experiences the ‘‘MEGO’’ effect (my eyes glaze over). This defeats the purpose of the CCR, which is to convey information in an understandable format. The CCR, or as most utilities are referring to it, the Water Quality Report, is a narrowly focused and limited communication product. If not done well—if the report appears either too self-serving or too alarmist—the report could help to undermine customer confidence in the public water system. The water quality report should be a component of a broader public education and communication program—it is just one tool in the toolbox (Speranza and Demit 1999).

17.7.3

Strategic Communications Planning

Strategic communications (see Table 17.1) planning can help a water utility remain proactive in meeting customer needs. The adoption of the CCR rule symbolizes a significant shift toward more public involvement in drinking water protection and treatment activities. Informed and involved citizens can be strong allies of water

17.7 COMMUNICATING WITH CUSTOMERS

TABLE 17.1 1. 2. 3. 4. 5. 6. 7. 8. 9.

445

Nine Steps to Better Strategic Communication

Survey the public and employees Analyze the situation List objectives Articulate themes and messages Identify the stakeholders (internal and external) Create tools and vehicles for communication. Develop an action plan (who, what, when, and resources) Implement and monitor the plan Incorporate regular feedback from customers and stakeholders

systems—or well-armed critics. Direct communication with customers takes many forms. Some of these communications are crisis-driven, such as public notification triggered by an acute violation of a standard, or service outages. Other times, the public is invited to provide input into policy decisions regarding new water resources, proposed treatment improvements, or rate increases to support new construction. In the past, public communication has often involved water quantity issues, such as the siting of a new reservoir, rather than water quality issues. However, as the public has become more educated about drinking water, utilities are becoming increasingly skilled at turning a public information process (a one-way process) into a public involvement process (a two-way process). 17.7.4

Stakeholder Involvement

Involving stakeholders in utility decisionmaking will broaden customer acceptance and support. Increasingly, water utilities have let the public decide whether they are willing to pay for additional treatment for water quality issues, and how best to comply with the expanding SDWA requirements. In Cincinnati in the mid-1990s, taxpayers approved a bond issue to pay for the construction of a granular activated carbon facility to provide for spill protection on the Ohio River and other water quality improvements. In Boston, the Massachusetts Water Resources Authority (MWRA) involved its ratepayer Advisory Board, a citizens’ advisory committee and an environmental group in the development of a consent order for compliance with the Surface Water Treatment Rule (SWTR). The MWRA’s approach to compliance, backed by its customers, withstood federal court challenges by the USEPA as the utility sought to invest in its disinfection and distribution facilities rather than a new filtration plant. There are hundreds of such examples, as the public becomes more sophisticated about water quality issues and utilities focus more on communicating risks and tradeoffs. Public involvement experts say that ‘‘it’s possible to have broad support, even in today’s skeptical world. The method is to make the publics part of the solution rather than part of the problem.’’ Aside from the immediate objectives of accom-

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plishing a successful project, the underlying goal is to have the utility ‘‘perceived as service-oriented public servants’’ rather than ‘‘non-responsive technocrats’’ (AWWARF=CH2M HILL 1995). A strategic approach to communication is as important as planning for any other utility function. Utilities looking for a place to begin should start by communicating with their employees, who are their front-line ambassadors. Communicating with customers should be the responsibility of all employees, not just the public affairs staff or the executive director. Water quality and operations staff, billing clerks, meter readers, and many others are all directly involved with customer communication. All employees live in or near the customer community, talk to their families and friends, and answer questions about the water utility to the best of their ability. They need to be as informed as possible so as to accurately represent the facts and the message that the water utility wants to convey to the public. 17.8

BENEFITS OF CUSTOMER COMMUNICATION

Why is customer communication so important? ‘‘Best practice’’ water utilities have found that an effective customer communication program is vital to their success and their competitiveness and ultimately to maintaining public support. It is also a lot more fun and a lot less stressful to have the public with you rather than against you. Some of the benefits that accrue to water utilities from good customer relations are:
The opportunity to tell your own story, rather than allowing others to define you. If a water utility does not share information about its operations with the public, somebody else will, and the utility will lose the opportunity to communicate accurately and fairly because it will be on the defensive.
Partnerships for source water protection are a natural place to harness public sentiment in favor of a key water utility objective.
Garnering support for financing infrastructure improvements will be an increasing need as regulatory requirements mount and the bill for replacing aging underground infrastructure comes due.
Public health protection, which should always be at the center of a water utility’s mission, is an objective shared by the public and a natural place to find common ground. Certainly, there will always be critics and those whose mission in life is to make the water utility manager’s life ‘‘interesting.’’ Taking the time and investing the resources in understanding and serving customers, however, always pays off in the long run. ACKNOWLEDGMENTS The author would like to acknowledge the many utility executives and public affairs practitioners who have contributed to an increasing understanding of the importance

REFERENCES

447

of public affairs and customer satisfaction in running a successful water utility. Particular thanks goes to the customers and advocates, staff, and Board of the Massachusetts Water Resources Authority for leading the way. REFERENCES AWWA=Hurd 1998. ‘‘AWWA Groups to Test and Refine Prototype Consumer Confidence Reports.’’ Washington DC. AWWARF. 1993. Consumer Attitude Survey on Water Quality Issues. Denver: AWWA Research Foundation. AWWARF=CH2M HILL. 1995. Public Involvement Strategies: A Manager’s Handbook. Denver: AWWA Research Foundation. CRPP. 1997. Customer Satisfaction Survey for the Regional Water Authority. New Haven, CT.: Center for Research and Public Policy. Denver Water. 1997. Water Quality Customer Survey. Denver, CO.: Bristlecone Marketing Inc. Hartz, J. and R. Chappell. 1997. Worlds Apart: How the Distance between Science and Journalism Threatens America’s Future. Arlington, VA: Freedom Forum First Amendment Center. Hurd, R. 1998. AWWA Focus Groups to Test and Refine Prototype Consumer Confidence Reports. WITAF Project 408. Denver: American Water Works Association. Hyde 2001. Communicating About Risk During Chaos Events. AWWA Water Quality Technology Conference. November 12, 2001. IBWA. 2000. Survey by Yankelovich Partners for the Rockefeller University and the International Bottled Water Association, www.bottledwater.org. Immerwahr, J. 1999. Waiting for a Signal: Public Attitudes toward Global Warming, the Environment and Geophysical Research. Public Agenda, April 15, 1999. NEETF. 1999. National Environmental Education and Training Foundation, July 1999. Roper Starch Worldwide Survey. National Report Card on Safe Drinking Water Knowledge, Attitudes and Behaviors. NEETF. 2001. Lessons from the Environment: Ninth Annual National Report Card on Environmental Attitudes, Knowledge, and Behaviors. National Environmental Education and Training Foundation. NSF. 1999. Science & Technology: Public Attitudes and Public Understanding. Washington, DC: National Science Board, Science and Engineering Indicators 2000. Pew Research Center. 2002. Counting on the Internet, Pew Internet and American Life Project, December 2002. PF. 2001. Service 2001: What are your customers saying and why? Planet Feedback, http:// biz.planetfeedback.com. Pfeffer, M. J. and J. M. Stycos. 2000. Final Report: Public Opinion on Environment and Water Quality Management in the New York City Watershed. Washington, DC: National Center for Environmental Research, Office of Research and Development, USEPA. RAC. 1999. Rebuild America Coalition Survey, www.rebuildamerica.org. RAND. 2000. Societal Trends Important to the Future of the U.S. Water Industry. AWWARF Project 2604, The Future of Water Utilities. RAND Environmental and Policy Center. Denver: AWWA Research Foundation.

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Rubin, S. 1996. Changing customer expectations in the water industry. NAWC Water (July). Sandman, P. 1996. It’s the outrage, stupid. Tomorrow (March–April). Speranza, E. and P. Demit. 1999. Consumer confidence reports: An opportunity for public outreach. Journal of New England Water Works Association (June). U.S. Census. 2000. Home Computers and Internet Use in the U.S. U.S. Census Bureau (August). U.S. Census. 2002. Supplemental Survey. U.S. Census Bureau (November 6). Wiley, T. and W. Chelikowsky. 2001. Customers as advocates—here’s how. Proc. AWWA Joint Management Conf.. Denver: AWWA. WQA. 2001. 2001 National Consumer Water Quality Survey, Water Quality Association, www.wqa.org. Yemma, J. 1996. The science of crying wolf. Boston Globe Magazine (April 21).

18 ACHIEVING THE CAPACITY TO COMPLY PETER E. SHANAGHAN Chief of Staff, Office of Ground Water and Drinking Water, U.S. Environmental Protection Agency, Washington, DC

JENNIFER BIELANSKI Drinking Water Utilities Team, Office of Ground Water and Drinking Water, U.S. Environmental Protection Agency, Washington, DC

18.1

INTRODUCTION

In 1996, Congress explicitly recognized the challenge that water utilities would face in achieving the public health protection objectives of the Safe Drinking Water Act (SDWA). Among the findings included in the SDWA Amendments of 1996 (P.L. 104-182) are the following: The requirements of the Safe Drinking Water Act now exceed the financial and technical capacity of some public water systems, especially many small public water systems More effective protection of public health requires prevention of drinking water contamination through . . . water systems with adequate managerial, technical, and financial capacity Compliance with the requirements of the Safe Drinking Water Act continues to be a concern at public water systems experiencing technical and financial limitations, and Disclaimer: The views expressed in this chapter are those of the authors and do not necessarily represent those of the USEPA. Drinking Water Regulation and Health, Edited by Frederick W. Pontius. ISBN 0-471-41554-5 # 2003 John Wiley & Sons, Inc.

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ACHIEVING THE CAPACITY TO COMPLY

Federal, State, and local governments need more resources and more effective authority to obtain the objectives of the Safe Drinking Water Act.

These findings reflect the extensive debate and deliberation on the SDWA that occurred from 1992 to 1996. This debate was informed, in part, by the U.S. Environmental Protection Agency’s (USEPA’s) September 1993 Report to Congress entitled Technical and Economic Capacity of States and Public Water Systems to Implement Drinking Water Regulations (USEPA 1993) and by the Agency’s principles for SDWA reauthorization (Shanaghan 1994). The basic water system institutional weaknesses, which led to congressional interest in the capacity issue, have been well documented. (NRC 1997, NRRI 1992, Washington State 1991) The 1996 SDWA Amendments included a significant focus on establishing new federal initiatives to enhance the capacity of water systems to comply with SDWA requirements. This chapter reviews capacity development in light of the 1996 SDWA and offers guidance on how water systems can achieve the capacity to comply with existing and future rules.

18.2

WATER SYSTEM CAPACITY

The 1996 SDWA Amendments established a new federal statutory framework to enhance the capacity of water systems to comply with SDWA requirements. This framework has three key components: 1. A requirement that states require a demonstration of technical, financial, and managerial capacity by any new community water system (CWS) or new nontransient noncommunity water system (NTNCWS) before such system commences operation 2. A requirement that states develop and implement capacity development strategies to assist public water systems in acquiring and maintaining technical, managerial, and financial capacity 3. A prohibition against provision of assistance from the Drinking Water State Revolving Fund (DWSRF) to any system not having the technical, managerial, and financial capability to ensure compliance (unless the assistance will help the system obtain such capability) Water system capacity is the ability to plan for, achieve, and maintain compliance with drinking water standards (USEPA 1998). Capacity development is the process of water systems acquiring and maintaining adequate technical, managerial, and financial capabilities to enable them to consistently provide safe and affordable drinking water. Understanding how water systems can best achieve the capacity to comply requires first understanding the three critical dimensions of capacity: technical, managerial, and financial.

18.2 WATER SYSTEM CAPACITY

18.2.1

451

Technical Capacity

Technical capacity is the physical and operational ability of a water system to meet SDWA requirements. The three key elements of technical capacity are source water adequacy, infrastructure adequacy, and technical knowledge and implementation. Source Water Adequacy The quantity and quality of source water available to a system is an important aspect of that system’s ability to comply. Insufficient quantity to meet customer demands could result in service interruptions, low pressure, and attendant public health risks. Poor source quality can result in high treatment costs, greater operational complexity, and low customer satisfaction. Infrastructure Adequacy The condition of a system’s physical infrastructure is a critical dimension of the system’s ability to comply. Physical infrastructure includes wells and=or surface intakes, treatment facilities, pumping stations, finished water storage facilities, and distribution systems. Technical Knowledge and Implementation The third key element of technical capacity is the operator’s expertise. The operator must have sufficient technical expertise and knowledge and must be able to implement that knowledge in the field day-in and day-out. This element can also be thought of in terms of operation and maintenance capabilities. 18.2.2

Managerial Capacity

Managerial capacity relates to a system’s institutional and administrative capabilities. It is the ability of a water system to conduct its affairs in a manner enabling the system to achieve and maintain SDWA compliance. The three key elements of managerial capacity are ownership accountability, staffing and organization, and effective external linkages. Ownership Accountability Ownership accountability is the cornerstone of a system’s capacity to comply. Ultimately, the accountability for SDWA compliance rests with the system owner. Capacity to comply begins with a clearly identified and accountable individual or institutional system owner. Staffing and Organization The second element of managerial capacity relates to having an effective organizational structure and the right staff for the jobs. In a very small system, such as a mobile-home park, this can be as simple as having a single owner or operator who devotes a few hours per week to system operation. In a very large system it can be quite complex with multilayered organizational structures and hundreds of employees. Effective External Linkages The third element of managerial capacity relates to the effectiveness of the system’s interactions with its key stakeholders. These

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stakeholders include customers, regulators, technical assistance providers, and financial assistance providers. 18.2.3

Financial Capacity

Financial capacity is a water system’s ability to acquire and manage sufficient financial resources to allow the system to achieve and maintain compliance with SDWA requirements. The three key elements of financial capacity are revenue sufficiency, creditworthiness, and fiscal management and controls. Revenue Sufficiency A system will simply be unable to achieve and maintain compliance if its revenues are not sufficient to meet its true full cost of doing business. Understanding costs and securing adequate revenues to meet them is a fundamental step in achieving the capacity to comply. Credit Worthiness The second element of financial capacity relates to the overall financial health of the system. Achieving the capacity to comply involves becoming credit worthy. Even financial assistance programs for disadvantaged communities generally include a loan component, and the programs have tests of creditworthiness appropriate to the systems they seek to serve. Clearly, every system cannot achieve the same degree of creditworthiness, but every system needs to become creditworthy by a measure appropriate to its circumstances. Fiscal Management and Controls The third element of financial capacity relates to managing whatever resources the system does have. Maintaining adequate books and records is a key step to achieving the capacity to comply. 18.2.4

Interrelationships among Capacity Dimensions

While each of the three major dimensions of capacity is distinct, they are closely interrelated. This is depicted in Figure 18.1 in terms of a Venn diagram. There is considerable overlap between any two dimensions, and the overlap between all three dimensions is best considered in the context of strategic planning and management. 18.3

ASSESSING WATER SYSTEM CAPACITY

The concepts of water system capacity and capacity development offer great intuitive appeal. However, if these concepts are to have any meaningful practical application, one must be able to somehow assess or measure system capacity. Assessment or measurement is not so important in absolute terms; one couldn’t say that system X has achieved capacity and no longer needs to seek improvements. Rather, assessment is critical in relative terms. That is to say, measurement of absolute capacity is not the goal but measurement of improvement in capacity, or capacity development, is what has practical significance.

18.3 ASSESSING WATER SYSTEM CAPACITY

Figure 18.1

453

Interrelationships between dimensions of capacity.

As part of their capacity development strategies, many states have developed tools to assist systems in assessing their capacity. In some cases, these tools consist of a series of yes=no-type questions designed to help systems understand where they may have weaknesses. An excellent example of such a tool is that developed by the South Dakota Department of Environment and Natural Resources, which is included in Appendix I. Some states, for example, Vermont, have developed a semiquantitative tool. Vermont’s tool is based on a series of yes=no questions, but includes a scoring protocol, which leads to the conclusion that a system’s capacity is excellent, good, or minimal. The State of Iowa has developed a series of self-assessment manuals tailored to specific ownership types: mobile-home park systems, privately owned systems, rural water association owned and municipally owned systems, and homeowner-association-owned and municipally owned systems using cash-basis accounting. These manuals pose a significant series of yes=no questions. Following that, the manuals advise users to take three steps: (1) to list the items to which they answered ‘‘No’’ and to do additional research or investigation to enable them to answer ‘‘Yes’’; (2) to make a qualitative summary of the most important things that come to mind in terms of strengths, weaknesses, opportunities, and threats; and (3) to do additional research or seek assistance to begin more quantitative business planning using worksheets provided. For the most part, the tools developed for capacity assessment by the states are designed to be used by systems themselves for initial self-assessment. Readily available sources of additional information can augment a water system self-assessment and help systems, States, and technical assistance providers understand the

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capacity development needs of any system. The most significant such source of additional information is the state sanitary survey. A sanitary survey is an on-site review of the water source, facilities, equipment, operation, maintenance, and monitoring compliance of a public water system for the purpose of evaluating the adequacy of such source, facilities, equipment, operation, and maintenance for producing and distributing safe drinking water. The purpose of a sanitary survey is to evaluate and document the capabilities of a water system’s sources, treatment, storage, distribution network, operation and maintenance, and overall management to continually provide safe drinking water and to identify any deficiencies that might adversely impact a public water system’s ability to provide a safe, reliable water supply. States have been conducting sanitary surveys for about as long as they have had drinking water programs. Sanitary surveys play an essential role in ensuring safe drinking water. While recognizing that each state is unique and has its own special approach to conducting sanitary surveys, USEPA has worked with the states to define the minimum elements necessary for a thorough system assessment (USEPA=ASDWA 1995). States tailor minimum elements on the basis of system type, size, and complexity. The USEPA=State guidance identifies eight essential elements for a sanitary survey:        

Source Treatment Distribution system Finished water storage Pumps, pump facilities, and controls Monitoring, reporting and data verification Water system management and operations Operator compliance with state requirements

The output from a sanitary survey is a written report documenting deficiencies identified during the survey. These sanitary survey reports can serve as measures of system capacity in a number of important ways. For instance, the number and severity of deficiencies identified is itself a measure of capacity; one would expect systems with strong capacity to exhibit fewer and less serious deficiencies than would systems of weaker capacity. The effectiveness and timeliness with which a system addresses identified deficiencies is also a measure of capacity. Stronger systems would be expected to correct deficiencies more quickly and more effectively than would weaker systems. Sanitary surveys are conducted by states at regular intervals, so that results can be compared over time to assess a system’s progress in developing capacity. Some observers have suggested compliance data as a key measure of capacity. Total and consistent compliance is the ultimate endpoint toward which all systems should be working. However, compliance is a useful measure of capacity only in

18.4 ENHANCING SYSTEM CAPACITY

455

relation to other measures. Monitoring and reporting violations is perhaps one of the most useful compliance measures to help assess system capacity. Repeated monitoring and reporting violations may indicate fundamental weakness in a system’s technical and managerial capacity. Reviewing such factors in the context of a comprehensive sanitary survey provides the perspective necessary to appropriately assess system capacity. Relying only on significant noncompliance as a measure of system capacity robs capacity development of its most fruitful potential: to prevent noncompliance! Just as modern medicine emphasizes prevention and focuses on risk factors for disease, so does capacity development emphasize prevention of noncompliance by focusing on ensuring the adequacy of a system’s technical, managerial, and financial capacity for compliance.

18.4

ENHANCING SYSTEM CAPACITY

The SDWA focuses on water system capacity development. This emphasis is not on some absolute measure of system capacity, but rather on a process through which systems acquire and maintain capacity. Capacity is thus viewed in the statutory framework as dynamic, not static. A variety of conceptual models can be advanced for enhancing system capacity. One useful conceptual model emphasizes capacity development over time in response to increasing SDWA regulatory requirements. This model is presented in Figure 18.2 and shows that systems are maintaining a baseline level of capacity. However, over time, as new SDWA regulations become effective, systems must increase their technical, managerial, and financial capacities in order to comply. Systems that fall within the ‘‘superior service’’ framework are those that are not

Figure 18.2

Building capacity in response to SDWA regulations.

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Figure 18.3

Building capacity through innovation and efficiency.

only in full compliance with SDWA but also go above and beyond what’s required in order to provide safe, adequate, and affordable drinking water to their customers. Another useful conceptual model emphasizes capacity development over time as a function of innovation and efficiency, among other factors. This model is depicted in Figure 18.3. System capacity is a function of several factors: time, money, training, technical assistance, and innovation and efficiency. If money, training, and technical assistance are held constant (or are limited as in the real world), over time innovation and efficiency will be a major contributing factor in increasing capacity. Indeed, this is where systems must look to increase capacity if other resources become limited or unavailable. The structure of the water industry in the United States is widely acknowledged to be fragmented and economically inefficient (Beecher 2002). Figure 18.4 depicts the overall number of regulated drinking water systems in the United States (see Appendix J for a more detailed statistical breakdown). The majority of households depend

Figure 18.4 U.S. public water systems.

18.4 ENHANCING SYSTEM CAPACITY

Figure 18.5

457

Community water systems: size distribution by population served.

on public water systems to supply them with drinking water. CWSs serve residential populations, NTNCWSs serve mainly schools and factories, while transient noncommunity systems (TNCWSs) serve mainly parks and rest stops. Most models tend to focus on the demographics of community water systems because most water consumption takes place in the home. As Figure 18.5 illustrates, the overwhelming percentage of community water systems is quite small. These are the communities whose cost per unit to produce potable water is highest and would stand to benefit most though capacity development. Figure 18.6 clearly illustrates the broad ownership diversity among small systems. In the categories of systems representing the largest population served, the number of public water systems decreases significantly. Publicly owned water systems predominate as population size increases, while private and ancillary systems are greatest in number among smaller communities. Figure 18.7 illustrates the ownership profile for systems classified as privately owned. This profile further supports the fact that most private systems are small. Privately owned small systems often lack the ability to maintain capacity without outside assistance. Finally, Figure 18.8 shows the inverse relationship between number of systems and popula-

Figure 18.6 served.

Ownership profile of community water systems by population size category

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Figure 18.7

Community water system ownership.

tion served. It is evident that the majority of the population served by public water systems is served by a low number of large systems while a very small amount of the population is served by very many small water systems. This figure raises concern over the impact of a lack of economies of scale at these small water systems. Given the fragmentation and economic inefficiency of the water industry in the United States, considerable interest has been devoted to the concepts of regionalization and industry restructuring (NRRI 1996). Consolidation and restructuring, like capacity development, offer great intuitive appeal. Consolidation can occur through physical interconnection or through management consolidation of noninterconnected systems. The economics of physical interconnection is depicted in Figure 18.9. Physical interconnection of water systems can be economical but may not always be the best choice for achieving capacity. After a certain distance is reached, the cost of transporting water between systems is not economically feasible. Systems that are considering physical interconnection as a means to continue operation may need to examine other economically viable capacity development solutions.

Figure 18.8 Five major system size categories: percent of systems versus percent of population served.

18.4 ENHANCING SYSTEM CAPACITY

459

Figure 18.9 Economics of physical interconnection.

The economics of common management is depicted in Figure 18.10. A cost savings can be realized by systems that consolidate management functions such as billing, collections, laboratory costs, and operator costs. Shared management between systems can be a proactive approach to building capacity when physical interconnection is not an economically viable option. The potential for consolidation, at least at the management level, appears quite substantial (Castillo et al. 1997). Figure 18.11 illustrates this point. As discussed earlier, installation of transmission lines over long distances is seldom economically feasible. Consolidation of management responsibilities, however, does provide systems with options to improve capacity while saving money. Given this enormous potential for consolidation, Figure 18.12 depicts the conceptual framework for alternative spatial boundaries (time and space) and depicts different ways to approach capacity development. USEPA (1999) notes that While considering the unique characteristics of a single system may lead to the development of a viable, system-specific program for achieving capacity, expanding the frame of reference will also increase the number of possible options available to a

Figure 18.10

Economics of common management.

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ACHIEVING THE CAPACITY TO COMPLY

Figure 18.11 Distance to the next closest community water system (weighted average of 17 states). system. For example, in a multi-system region, a system may be able to consolidate with a neighboring system either physically or managerially. At the county level, regionalized efforts to accomplish water-related goals, such as source protection or operator training, will enhance the system’s ability to comply with capacity development requirements. Finally, the economic analysis at the State level may reveal that the system is in a disadvantaged area, making it eligible to receive additional financial support.

The wide spectrum of possibilities for partnerships is illustrated in Figure 18.13. There are different methods of achieving economies of scale and improving efficiency. On the informal end, a system may have informal cooperation (in the form of

Figure 18.12

Solving small system problems: alternative spatial boundaries.

18.5 FUTURE OUTLOOK

461

Figure 18.13 System partnership spectrum.

verbal agreements). Some systems may contract out for specialized services such as using a contract operator, or using other billing and administrative services. A cooperative is a more formal partnership, but some degree of independence is retained. Mergers and acquisitions provide the best situation for an economy of scale because there is initiative to reduce redundant functions and increase efficiency. Central to any discussion of water system partnerships, consolidation, or restructuring is the issue of how strongly many small systems value local control. Figure 18.14 provides a value neutral framework for consideration of that concern. The figure treats it as an economic issue represented by an indifference curve. Local control and potential for economies of scale are the goods and in order for systems to achieve an economy of scale, systems must be willing to at least consider relinquishing some amount of local control.

18.5

FUTURE OUTLOOK

Because of the fragmented nature of the water industry in the United States, water systems (especially small water systems) face many challenges in the quest to

Figure 18.14 The economies of scale versus local control tradeoff: a water supply system indifference curve.

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achieve and maintain capacity. State capacity development programs are assisting systems to overcome barriers that prevent them from enhancing capacity. Facilitating change in the water industry may not be an easy task; however, promoting change that leads to an economy of scale may be one of the best ways to ensure that systems are not only complying the SDWA requirements but are also going above and beyond what’s required in order to provide safe, adequate, and affordable drinking water to their customers. REFERENCES Beecher, J. A 2002. Value, structure, and regulation: select issues affecting the water industry 2001. A paper prepared for the 2002 National Drinking Water Symposium, St. Petersburg, FL, March 24–26, 2002. Castillo, E., S. K. Keefe, R. S. Raucher, and S. J. Rubin. 1997. Feasibility of Small System Restructuring to Facilitate SDWA Compliance. Denver: AWWA Research Foundation. NRC. 1997. Safe Water From Every Tap: Improving Water Service to Small Communities. Washington, DC: National Research Council. National Academy Press. NRRI. 1992. Viability Policies and Assessment Methods for Small Water Utilities. NRRI 91-17. National Regulatory Research Institute. NRRI. 1996. The Regionalization of Water Utilities: Perspectives, Literature Review, and Annotated Bibliography. NRRI 96-21. National Regulatory Research Institute. Shanaghan, P. E. 1994. Small systems and SDWA reauthorization. J. Am. Water Works Assoc. 86:52. USEPA. 1993. Technical and Economic Capacity of States and Public Water Systems to Implement Drinking Water Regulations: Report to Congress. EPA 810=R-93=001. Washington, DC: Office of Ground Water and Drinking Water. USEPA. 1998. Information for States on Implementing the Capacity Development Provisions of the Safe Drinking Water Act Amendments of 1996. EPA 816-R-98-008. Washington, DC: Office of Ground Water and Drinking Water. USEPA. 1999. Handbook for Capacity Development: Developing Water System Capacity under the Safe Drinking Water Act as Amended in 1996. EPA 816-R-99-012. Washington, D.C.: Office of Ground Water and Drinking Water. USEPA=ASDWA. 1995. United States Environmental Protection Agency and the Association of State Drinking Water Program Administrators. EPA=State Joint Guidance on Sanitary Surveys. In Guidance Manual for Conducting Sanitary Surveys of Public Water Systems; Surface Water and Ground Water under the Direct Influence of Surface Water. EPA 815-R99-016. Washington, DC: Office of Ground Water and Drinking Water. Washington State Department of Health. 1991. Small Water Systems: Problems and Proposed Solutions. A Report to the Legislature. Olympia, WA: Washington Dept. Health.

19 ACHIEVING SUSTAINABLE WATER SYSTEMS JANICE A. BEECHER, Ph.D. Director, Institute of Public Utilities, Michigan State University, East Lansing, Michigan

19.1

INTRODUCTION

As water systems strive to comply with the requirements of the Safe Drinking Water Act (SDWA), their financial resources may be stretched to new limits. Systems without adequate financial capacity, technical and managerial capacities suffer collaterally. Many water systems will need to reexamine the role of rate revenue in supporting the cost of providing water service. The demands of SDWA, along with infrastructure needs in general, provide a strong motivation for water systems to establish sustainable water pricing. For the purposes of this chapter, a sustainable water system is one that is financially self-sufficient; that is, the system relies primarily, if not exclusively, on revenues from water rates to pay for all capital and operating needs. Further, consistent with the tenets of capacity development, external subsidies are used only in the short term to help the system achieve financial capacity and selfsufficiency. Internal subsidies or funding from revenue sources other than rates and charges to water customers are prohibited or kept to a minimum. A sustainable price, therefore, is one that will generate sufficient revenues to ensure the sustainability of the water system as it meets the entirety of its service obligations, including SDWA compliance (Fig. 19.1). The concepts of sustainability and sustainable pricing raise both theoretical and practical issues. Sustainable pricing is grounded in pricing theory, which stresses economic efficiency as a fundamental goal. Efficient prices established on the basis Drinking Water Regulation and Health, Edited by Frederick W. Pontius. ISBN 0-471-41554-5 # 2003 John Wiley & Sons, Inc.

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Figure 19.1

Goals of sustainable pricing (source: USEPA).

of the marginal cost of production reflect the ‘‘true’’ cost of providing service. Efficiency is a necessary but not sufficient element of sustainability. A sustainable price also must be an affordable price (Fig. 19.2). A system that cannot serve its customers at an affordable price cannot be sustained by that customer base over time. Water systems that are sustainable overall may choose from various rate design and other strategies to improve affordability for the service population.

19.2

SUSTAINABLE SYSTEMS

The term ‘‘water system’’ can be used to describe the series of conveyances that supply treated water to customers. But water systems also are systems in a broader respect that is relevant to the concept of sustainability.

Figure 19.2 Elements of sustainable pricing (source: USEPA).

19.2 SUSTAINABLE SYSTEMS

Figure 19.3

19.2.1

465

Water systems within larger systems (source: USEPA).

Systems Perspectives

Systems theories are used to study creatures of nature, as well as creations of people, such as political systems. A system is essentially a collection of relationships. The boundaries of a system can be defined in physical terms (such as spatially defined systems) or metaphysical terms (such as socially defined systems). Systems can be concentric, with smaller systems operating within larger systems (Fig. 19.3). Systems also have a temporal or dynamic dimension. In other words, the relationships that define a system often change over time. Systems vary in size, complexity, and composition. A conceptual distinction can be made between ‘‘open’’ and ‘‘closed’’ systems (Figs. 19.4 and 19.5). A closed system is virtually self-contained, suggesting that all activities, transactions, and feedback mechanisms are internal to the system. Internal resources are used to satisfy

Figure 19.4

A simplified ‘‘open’’ water system (source: USEPA).

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Figure 19.5

Water pricing in a ‘‘closed’’ water system (source: USEPA).

internally defined needs. A closed system is, by definition, self-sustaining—it must live within its means. Biospheres, ships at sea, and space stations can be regarded as closed systems. But even these systems interact with external systems at some level or point in time, and thus are not entirely closed. In reality, no system is perfectly closed, and openness is a matter of degree. Most systems are intertwined with or dependent on other systems to some extent. Biological systems, including human beings, are systems that interact constantly with other systems. At times, the boundaries among complex systems may be blurred. The more open the system, the greater the potential for ‘‘outside’’ influence. Just as systems are affected by their environment, systems can affect their environment. Moreover, the activities of systems have external effects (outputs) and consequences (outcomes), which can lead to reactions in the environment that in turn affect the system (feedback). 19.2.2

Water Systems as Systems

What kind of system is a water system? Water systems are systems in the conventional engineering sense. But water systems also are institutional creations with properties of both open and closed systems. A water system is open to the extent that it interacts continuously with other systems: the natural systems that yield water, other utility service providers, local political economies, and regulatory institutions. The water system must be prepared to react to forces of change exerted by these other systems. For example, a drought or a new regulatory requirement can trigger a reaction on the part of the system. The water system also exerts influences. The quality and quantity of water provided affect the service population. Water systems that perform poorly risk negative feedback from regulatory and other systems in their environment. Despite the very open nature of water systems, the idea of sustainability also suggests the potential relevance of the closed-system concept. Sustainability

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suggests a high degree of self-reliance. A water system can be considered close to the extent it generates resources, identifies systemic problems, and resolves issues internally. In terms of financial capacity, a sustainable water system should not require a subsidy for operating costs from external sources nor should the system shift costs to future generations. Thus, water pricing plays a central role in sustainability. A water system that is completely sustainable by virtue of pricing would not require revenues from sources other than ratepayers. For example, a municipal system that is fully sustained by rates or user charges would not need or use supplemental revenues from local sources (such as taxes and fees) or nonlocal sources (such as grants). As compared to grants, a loan that generally reflects the market rate of interest and that can be repaid through revenues from rates would not undermine a system’s sustainability. In other words, the system is not dependent on an external or superseding system. Ideally, the price charged for water service will recover the true (or ‘‘marginal’’) cost of providing the service. A system might be sustained by internal sources of revenue other than prices, but doing so undermines the economic efficiency of the system because it distorts and mutes the price signal to customers and cause them to overconsume, which in turn would lead to higher than necessary costs. Similarly, the price charged should not be excessive in order to provide an additional revenue source to the system, as this leads to underconsumption and an unjustified impairment of lifestyles. Pricing for sustainability improves both the economic efficiency of the water system and the consumption behavior of the water user, serving the societal purposes of water resource conservation and preservation.

19.2.3

Sustainability and System Size

A key strategy for making any system more sustainable is to optimize size (Fig. 19.6). Given very favorable circumstances, small systems can be sustainable.

Figure 19.6 Sustainability and system size (source: USEPA).

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ACHIEVING SUSTAINABLE WATER SYSTEMS

But as a general proposition, and with exceptions, sustainability is more readily achievable for larger water systems. Three closely related economies lend support to this proposition. First, larger systems enjoy economies of scale in production, which translates into a lower cost per unit of output (measured in dollars per gallon of water produced). Production economies of scale can be achieved not only in source development and treatment but also in customer services. Service area density enhances these economies. A second and complementary perspective is that larger systems have a larger customer base over which to spread costs, measured in dollars per customer served. In other words, the economies of scale in production also are reflected in the unit costs per customer for the larger collective. A third perspective is that larger water systems also enjoy a more diverse base over which to spread costs. This effect can be measured in terms of costs relative to ability to pay, or income. The diversity of the customer base is reflected in the mix of customers (residential and nonresidential), water usage patterns, and socioeconomic conditions. Larger systems are better able to cope with particular ability-to-pay problems within the service community. Rate design and customer assistance programs generally are more feasible for larger systems. Diversity in the service territory provides opportunities to lower costs, as well as to introduce alternative rate structures, including lifeline and other rates that specifically address affordability concerns. A more diverse customer base might also include large-volume customers, whose water requirements add to production and expand opportunities to achieve economies of scale. Even a limited number of high-volume users can benefit the entire water system. The potential limits to economies of scale are a relevant consideration. A system that exceeds its optimal size because of technical constraints (such as barriers to long-distance wheeling) might become inefficient and unsustainable if costs become exorbitant. In other words, a water system might become so big that economies of scale are exhausted (or returns to scale begin to diminish). Limits to economies of scale can be apparent, for example, in the physical extension of water systems across long and=or sparsely populated distances (hydraulic interconnection). In other words, economies of scale in production are offset by diseconomies in transmission. The limitations of scale economies for other aspects of utility operations (e.g., management, planning, financing, and customer services) are not so constrained. In general, the vast majority of water systems have not begun to approach diminishing returns to scale.

19.3

SUSTAINABILITY AND THE SDWA

The term ‘‘sustainability’’ does not appear in the SDWA. Nonetheless, the SDWA provides a basis and framework for the concept of sustainability through three major policy themes: capacity development, affordability, and conservation planning.

19.3 SUSTAINABILITY AND THE SDWA

19.3.1

469

The SDWA and Capacity

The 1996 SDWA places a clear emphasis on the capacity of water systems and the need for capacity development (USEPA 1998b). Capacity development is addressed through three key provisions: 1. The law requires states to develop and implement programs to ensure that all new community water systems and new nontransient noncommunity water systems demonstrate the technical, managerial, and financial capacity to comply with all national primary drinking water regulations. 2. States must also develop and implement a strategy to assist existing systems in acquiring and maintaining technical, managerial, and financial capacity. 3. The law ties a water system’s eligibility to receive assistance under Section 1452 to the system’s technical, managerial, and financial capacity. In short, the law prohibits Drinking Water State Revolving Fund (DWSRF) assistance to systems that lack the technical, managerial, and financial capacity to ensure compliance with SDWA requirements unless the system agrees to restructuring changes to ensure that it has the necessary capacity to comply with the Act over the long term. The Act also establishes DWSRF withholding requirements for states that fail to meet the capacity development provisions. Each of these three elements of capacity—technical, managerial, and financial—is interrelated with the others; without one of the elements, systems may be in jeopardy of noncompliance with federal drinking water standards, as well as underperformance in other regards. Financial capacity in many respects is the key to achieving technical and managerial capacity. It is defined in terms of revenue sufficiency, creditworthiness, and fiscal management and controls. Without financial resources, water systems—small or large—cannot achieve performance goals. The key to financial capacity is revenue sufficiency, which rests in large part on how much water systems charge for the product they deliver to customers. Systems need revenues to support the cost of service, which requires a mechanism for pricing. Prices that reflect water’s true cost and value can ensure a water system’s financial capacity and sustain its operations over time. 19.3.2

The SDWA and Affordability

Several key provisions of the SDWA require explicit consideration of affordability by the U.S. Environmental Protection Agency (USEPA), as well as the state primacy agencies. These various provisions are summarized in Table 19.1. Affordability is addressed in the Act in provisions related to affordable technologies based on national criteria, variance technologies, small system variances, eligibility for state revolving funds, and funding for disadvantaged communities. USEPA’s Information for States on Developing Affordability Criteria for Drinking Water (USEPA 1998c)

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TABLE 19.1 Key Affordability Provisions of the SDWA Affordable technologies. When promulgating new national primary drinking water regulations, USEPA is to identify technologies that are affordable and that achieve compliance for categories of systems serving fewer than 10,000 (further divided into systems serving between 25 and 500, 501 and 3300, and 3301 and 10,000). Technologies may include packaged or modular systems and point-of-use (POU)= point-of-entry (POE) units under the control of the water system (no POU for microbial contaminants) [Sec.1412(b)(4)(E)]. Variance technologies. Whenever an affordable technology cannot be identified that meets an MCL, USEPA is required to identify ‘‘variance technologies’’ that are affordable, but do not necessarily meet the MCL. Such technologies shall ‘‘achieve the maximum reduction or inactivation efficiency that is affordable considering the size of the system and the quality of the source water.’’ USEPA is to issue guidance on variance technologies for existing regulations within 2 years [Sec. 1412(b)(15)]. Small system variances. States are authorized to grant variances from standards for systems serving up to 3300 people if the system cannot afford to comply (through treatment, an alternative source, or restructuring) and the system installs the variance technology. The terms of the variance must ensure adequate protection of human health. States can grant variances to systems serving 3301–10,000 people with USEPA approval [Sec. 1415(e)]. Information to states for development of criteria. Within 18 months of enactment, USEPA, in consultation with the states and the Rural Utilities Service of the Department of Agriculture, must publish information to assist states in developing affordability criteria to use in making variance determinations. The SDWA specifies that affordability criteria shall be reviewed by the states at least every 5 years to determine if changes to the criteria are needed [Sec. 1415(e)(7)(B)]. State Revolving Fund. Projects are eligible for funding if they ‘‘will facilitate compliance with’’ applicable national drinking water regulations or will ‘‘significantly further the health protection objectives’’ of SDWA. States will annually prepare intended use plans identifying eligible projects and their priority. An intended use plan shall provide, to the maximum extent practicable, that priority for the use of funds be given to projects that (1) address the most serious risk to human health, (2) are necessary to ensure compliance with the requirements of the SDWA (including requirements for filtration), and (3) assist systems most in need on a per household basis according to state affordability criteria [Sec. 1452(3)(A)]. Disadvantaged communities. The states may use up to 30 percent of their capitalization grant to assist disadvantaged communities, including forgiveness of loan principal. Disadvantaged communities are defined in terms of the service area of a public water system that meets affordability criteria established after public review and comment by the state in which the public water system is located [Sec. 1452(3)(A)].

provides states with an overview of methodologies that have been used to evaluate the affordability of compliance with environmental regulations, including, but not limited to, drinking water regulations. The information piece and related materials also provide a framework, illustrated in Figure 19.7, for assessing affordability. Indicators of affordability organized according to the proposed framework can be used to evaluate:

19.3 SUSTAINABILITY AND THE SDWA

     

The The The The The The

471

affordability of water service to households water system’s general financial capacity water system’s access to private capital water system’s access to public capital fiscal condition of relevant local governments community’s socioeconomic conditions

A particular challenge for USEPA under the SDWA as amended in 1996 is the establishment of national level affordability criteria for use in the evaluation of proposed regulations, as well as variance policies. USEPA has explored a variety of methods for assessing affordability and a variety of affordability ‘‘thresholds’’ (USEPA 1998a). At issue for some stakeholders is whether standards should be set on the basis of affordability for the majority of the population, most of whom are served by larger municipal water systems, or for the many customers of small systems, many of which face high costs. A further complication is the presence of ‘‘pockets of poverty’’ within many larger communities. As a result of its analysis of national affordability, USEPA selected a national level affordability threshold of 2.5% of median household income for water service alone, not including wastewater service (1998e). This compares to average consumer expenditures for water and other public services (wastewater and solid-waste management) of less than 1%. This average, of course, masks wide variations in what households actually pay for water services. Water services also command a smaller share of the household budget than do energy and telecommunications services, as well as more discretionary consumer purchases. The 2.5% threshold

Figure 19.7

Generalized resource flows to and from water systems (source: USEPA).

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permits an expenditure margin within which utilities can devote rate revenues to investments needed for SDWA compliance. Of course, noncompliance investment needs will also place upward pressure on rates and close the margin. USEPA’s national level affordability threshold serves to guide the agency on the listing of an affordable compliance technology versus a variance technology for a given system size–source combination for a given contaminant. It is based on a national level analysis for a typical system within a specified size category, and does not represent an affordability assessment for any individual water system. Water rate increases from 1% to 2.5% are obviously significant and will raise a range of ability-to-pay and willingness-to-pay concerns for specific water systems. From the water utility perspective, a number of factors affect the actual impact of water rate increases on households: (1) structural change and efficiency measures may help some systems absorb cost increases while lessening rate impacts, (2) rate design alternatives may make it possible to mitigate the effect of rate increases on low-income households, and (3) assistance to individual households (as compared to traditional assistance to water systems) may offset the potential hardship of high household utility costs. Indeed, the infrastructure funding debate has brought attention to the possible need to establish an assistance program like those authorized at the federal level for the energy and telecommunications sectors (respectively through the Low-Income Home Energy Assistance Program and the Lifeline=Linkup programs). 19.3.3

The SDWA and Conservation Planning

Sustainability has obvious links to efficient water use, which can be promoted through long-term planning and strategies for integrated management of water supply and demand. SDWA Section 1455 required USEPA to publish Water Conservation Plan Guidelines (USEPA 1998d). The states, at their discretion, can require conservation planning as part of their existing regulatory program and=or in conjunction with determining eligibility and priority for DWSRF funds. Use of USEPA’s conservation planning guidelines is strictly voluntary. However, the planning principles and processes reflected in the guidelines are very consistent with the long-term goals of compliance, capacity, and affordability. USEPA’s guidelines provide a basic planning framework for small systems (serving up to 10,000 people), an intermediate planning framework for medium systems (serving up to 100,000 people), and an advanced planning framework for larger water systems (serving more than 100,000 people). In addition, a modified basic approach is provided for very small water systems. The basic conservation practices recommended for very small systems complement each of the essential areas of capacity emphasized in the SDWA: technical (metering and leak detection), managerial (public education), and financial (rates). 19.3.4

Implications

In many respects, the concept of long-term capacity is similar (if not identical) to the concept of sustainability. A water system that enjoys adequate technical, financial,

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and managerial capacity is sustainable; without capacity, sustainability is doubtful. Capacity assurance for new systems clearly suggests that new systems should be sustainable; capacity assistance for existing systems implies sustainability as a fundamental goal. The prohibition against funding for systems that lack capacity clearly suggests the legislative intent that funding should be provided only to sustainable systems. Providing funding for nonsustainable systems is not considered a good investment; funding that provides a transition to capacity and sustainability (including structural change if necessary) has much greater appeal. Sustainability as a policy goal also suggests that the linkage between water users and water systems in the form of cost-based and affordable user chargers is a critical one. Although systems might have a variety of resources at their disposal, including grants and subsidies from government, pricing water correctly is essential. What the framework implies is that, in the long term, a sustainable water system will rely more on revenues from its service base than on ‘‘outside’’ sources. Finally, sustainable pricing is highly consistent with the goals of conservation planning and a more efficient balance between water supply and water demand over the planning horizon. 19.4

AFFORDABILITY AND SUSTAINABILITY

As already suggested, affordability and sustainability are intrinsically related. For some water systems, the rate required to support the cost of service might not be considered affordable, in which case long-term sustainability is jeopardized. In other words, a sustainable price must meet the needs of both water systems (in terms of revenue sufficiency) and customers (in terms of affordability). 19.4.1

Ability versus Willingness to Pay

An important distinction when considering affordability and sustainability is the difference between willingness to pay and ability to pay. Willingness to pay reflects consumer preference about purchasing a quantity of goods or services relative to prices and is reflected in a ‘‘demand curve.’’ As prices rise, particularly for essential goods and services, consumers may demonstrate a reluctance or unwillingness to pay. A price-responsive consumer, for example, might reduce water usage in response to a rate increase. Put differently, willingness to pay is based on people’s perception of the reasonableness of a price relative to their perception of the quality of a good or service. Economists recognize that the willingness to pay for a good or service also reflects the ability to pay. Preferences reflected in the demand curve are a function of the ability to pay as defined by income. Clearly, households with higher levels of income have greater ability to pay for all kinds of goods and services. In a pure sense, the demand curve represents both the willingness and the ability to pay. Nonetheless, ability to pay remains a useful concept on its own because it raises a distinct set of social and policy concerns related to affordability. The ability to pay is primarily a function of income in relation to the cost of living, which in turn is

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primarily a function of employment. Income (weighted by the cost of living) and employment measures often are used in estimating a community’s socioeconomic conditions and the related ability of consumers to support utility costs. For low-income households, the higher proportion of income allocated to fixed expenditures for essential goods and services (housing, food, utilities) can make paying bills more difficult. Many essential goods are price-inelastic, meaning that consumers find it extremely difficult to reduce usage even in the face of rising prices. The availability of income assistance or bill payment assistance programs can mitigate this problem. One of the most difficult issues raised in the context of drinking water standards is the fundamental tradeoff between affordability and quality. The Act does not allow for variances or exemptions that would jeopardize pubic health (such as for microbial contaminants). However, a relaxation of standards is allowed under some conditions, suggesting acquiescence to product differentiation according to the ability to pay. Sacrificing even a slight degree of quality for some citizens in the interests of affordability raises fundamental ethical and equity issues.

19.4.2

Affordability Thresholds

Government agencies sometimes use affordability thresholds to determine whether price increases designed to pay for standards compliance or other needs would be considered affordable. Although the use of thresholds has many limitations, it also has relevance for this discussion of sustainability. Affordability thresholds often are measured in terms of the water bill as a percentage of income. Whether water is considered affordable depends on the water bill, as well as the service population’s ability to pay. A 3% threshold in a wealthy service population with high levels of water usage produces considerably more revenue than a 3% threshold in a poor area with low levels of water usage. Average expenditures (the baseline) and affordability ‘‘thresholds’’ are expected to increase with household income levels. But subpopulations that are povertystricken or on fixed incomes are especially vulnerable to affordability problems with regard to utility services. A system may not be sustainable if its service territory is very poor because there exists no ability to provide assistance or otherwise subsidize the cost of service internally (within the service territory).

19.4.3

Utility Assistance Programs

As costs and prices rise, water utilities can implement a variety of measures to improve affordability for customers in their service territories. These measures include  Adjustments to billing cycles, including monthly or budget bill programs  Arrearage (late payments) forgiveness and other means to avoid disconnection  Voluntary assistance funded by customer contributions, often with matching funds provided by the utility

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 Assistance or program administration through local charitable organizations  Conservation-oriented programs to help customers lower their monthly water usage and bills  Lifeline rates and other rate discounts (such as reductions in fixed charges)  Increasing-block rates that price the first block of usage at a rate considered generally more affordable  Voucher or coupon programs that maintain the price signal, while providing payment assistance to households based on need. Water utilities often have been reluctant to implement programs to assist low-income customers. The reasons for this reluctance are understandable. Establishing eligibility can be cumbersome, while also raising a number of privacy issues. Implementation can be expensive, increasing costs to all customers. Rates that improve affordability can undermine the price signal and discourage conservation. For regulated utilities, which include most investor-owned utilities and some municipal utilities, regulatory policy may discourage establishment of assistance programs. Economic regulation tends to emphasize the importance of basing rates on the cost of service in order to achieve efficiency goals. However, some utilities and regulatory agencies have acknowledged the need to provide assistance. A key rationale behind providing such assistance is that it can enhance the financial integrity of the system by improving bill payment behavior, reducing arrearages and uncollectible accounts, and avoiding costly and damaging disconnection practices. Assistance programs for water service are not widely available. Nonetheless, experience in this area is growing. Assistance programs can help water systems maintain affordability for particular subpopulations. However, the cost of assistance becomes part of the overall cost of service that must be sustained by the customer base as a whole.

19.4.4

Rate Design and Affordability

Varying assumptions about rate design can affect the results of an affordability analysis in important ways. In other words, the effect of rising costs on affordability can be exaggerated or mitigated by means of the rate structure. Water systems should explore rate-design options when contemplating the household impact of cost and price increases. The intrinsic relationship between rate design and affordability has direct and meaningful implications for regulatory variances, which in turn have equally relevant implications for equity in terms of service quality. The USEPA considers affordability in the identification of compliance technologies. States can grant variances from compliance standards for systems serving up to 3300 people if the system cannot afford to comply (through treatment, an alternative source, or restructuring) and the system installs the variance technology. While the terms of the variance must ensure adequate protection of human health, the customers of a system receiving a variance may receive lower-quality water as a result of the

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variance. The authorized rate structure can determine whether a system falls above or below a state’s affordability threshold for compliance, thus determining a system’s eligibility for a variance. Progressive rate structures, such as lifeline rates and consolidates rates (single-tariff pricing), can affect whether a system qualifies for a variance, and therefore whether water customers in a given community will have lesser water quality, albeit ‘‘safe’’ from a regulatory standpoint. Water systems should consider affordability when designing rate structures; they also should consider alternative rate structures when contemplating an application for a variance on affordability grounds. The policy implications of the potential tradeoff in water quality that might come with alternative rate structures are not insignificant. State policymakers should take this tradeoff into account when developing affordability criteria, as well as when assessing affordability for individual systems. In particular, it may be important for state public utility regulators (who approve rates for most private and some other systems) and state drinking water primacy agencies to develop a coordinated response to this issue. Equity considerations may play a role in reforming rate-design policy. 19.4.5

The Role of Subsidies

The concept of sustainability raises the issue of whether and when subsidies to a water system or its customers are appropriate. In ratemaking, and in other pursuits, subsidy can have a highly pejorative meaning. In reality, all manner of economic activities are subsidized through taxes and other means. Indeed, all rate structures that group customers and average costs among them embed (at least) minor subsidies (that is, all ratemaking involves averaging). Some subsidies are justifiable in the interest of equity considerations and longterm policy goals; others are avoidable. In accordance with the capacity development provisions of the SDWA, a short-term subsidy might be appropriate in order to help a system make the transition to long-term capacity. Consistent with the SDWA, state revolving loan funds might be used to help a system make the transition to sustainability by restructuring or interconnection with another water system. Subsidies can be provided within systems (internally) or from outside a system (externally), as illustrated in Table 19.2. By definition, a sustainable system does not depend on external subsidies, such as grants. Other forms of outside assistance also might involve subsidies from the national, state, or local communities within which water systems operate. Loans, however, may or may not constitute a significant subsidy. If the loan is at or near market rates and can be repaid through revenues generated through rates charged for service, the amount of external subsidy is minimal. A sustainable system may find it appropriate to use internal subsidies. Some rate structures, such as lifeline rates, confer benefits on some ratepayers at the expense of others. Utilities generally prefer to allocate costs among the classes based on the cost of service, consistent with economic theory. Significant departures from the cost-of-service standard put the utility at risk of criticism from regulators and

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TABLE 19.2 Types of Subsidy Type of Subsidy Internal subsidies Intraclass Interclass Intrasystem Payment assistance to individuals External subsidies Charitable assistance to individuals Payment assistance to individuals Economic development assistance Financial assistance to water systems

Provides the Subsidy

Receives the Subsidy

Residential ratepayer A Nonresidential ratepayer Higher-cost customers Ratepayers through voluntary contributions

Residential Residential Lower-cost Residential

ratepayer B ratepayer customers ratepayer

Charitable organizations

Residential ratepayer

Governmental agency (federal, state, or local) Governmental agency (federal, state, or local) Governmental agency (federal, state, or local)

Residential ratepayer Nonresidential ratepayer Water system

customers. Shifting costs to nonresidential customers may cause them to bypass the system altogether. Some level of subsidy can be justified, however, in terms of promoting revenue stability, reducing delinquency and uncollected accounts, fulfilling the utility’s obligation to serve, and acting in accordance with good corporate citizenship.

19.5

PRICING THEORY

Sustainability also finds support in pricing theory. An efficient price is based on costs, specifically marginal costs, and encourages consumption and production decisions that should be sustainable over time. A genuinely sustainable price, however, is both efficient and affordable. A clear tension exists between the goals of efficiency and affordability, or more broadly, between efficiency and equity. This tension can present a formidable, although not insurmountable, goal for public policy. 19.5.1

Efficiency

Economic theory argues for utility pricing that promotes overall efficiency for society. An efficient price signal leads consumers to consume, and producers to produce, an appropriate amount of a good or service. As noted, prices that are too low can lead to overconsumption (and underproduction); prices that are too high can lead to underconsumption (and overproduction). This mismatch of supply and demand, and the ‘‘welfare loss’’ associated with it, has rippling effects throughout the economy because in using excessive resources to produce a good, or spending too much for that good, society foregoes opportunities to use those resources or

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expenditures elsewhere. Economic theory also argues for utility pricing that is equitable in terms of allocating costs to the customers responsible for those costs. Of course, other theoretical perspectives argue for different kinds of equity, such as social and political equity. In this conception, however, equity essentially serves efficiency goals. Economists long have argued for prices that reflect costs and against subsidies that distort price signals. Modern pricing theory more specifically calls for pricing based on marginal costs; that is, prices should reflect the incremental cost of producing an additional increment of a good. Prices based on long-term marginal costs will help achieve long-term efficiency in deploying society’s resources. Pricing theory, of course, relies heavily on the theory of competitive markets. In several respects, water service does not comport with assumptions about competition:  Water utilities are highly monopolistic. For investor-owned water utilities, prices are set in a regulatory process that attempts to replicate the discipline of the competitive marketplace in terms of promoting economic efficiency.  The lack of quality differentiation and substitution also presents a problem. Water service must meet minimal health and other standards; product differentiation is highly constrained—and although the methods of delivery vary, water itself has no real substitutes and customers cannot substitute another service for water service.  Finally, water is a natural resource—abundant but finite. Natural forces affect the supply and demand for water. It is unlike many other consumer goods and services. All of these reasons may require special adaptations of pricing theory to the case of water.

19.5.2

Prices, Income, and Demand

Efficient prices are based on costs. Over time, however, prices affect consumer demand, which in turn affects producer supply, which in turn affects system costs. Of course, demand is not a function of price alone. Economists use elasticity estimation to assess the potential impact of changes in prices and income on demand. Elasticity is a measure of the percentage change in one variable in response to a percentage change in another variable. The price elasticity of demand for a good or service, based on the intrinsic economic relationship between prices and quantities, measures changes in the quantity demanded associated with changes in the price for the good or service. The price elasticity of demand is a negative number. With a price elasticity of 0.20, for example, a 10% increase in price is associated with a 2% decrease in demand. The price elasticity for water demand has been estimated in a variety of empirical studies (Beecher et al. 1994). These studies are imperfect to the extent that they use aggregate data to test microeconomic theory about individual

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responses to changes in price. Most of these studies are cross-sectional, and few studies actually examine changes in price and quantity for a group of customers over time. For residential customers, winter (or indoor) water use is very inelastic (or unresponsive to changes in price). Summer (or outdoor) use is also inelastic, but somewhat more price-responsive than winter (or indoor) use. Water use by multifamily residential customers also is less responsive to price than that by singlefamily customers. If multifamily housing tends to consist of lower-income customers, this finding has implications for affordability. Price changes will not induce significant reductions in use that could lower total water bills. Nonresidential (commercial and industrial) water consumption is considered more responsive to changes in price. Although price is a key determinant, the consumption of goods and services also varies according to other variables, particularly income. As compared with price elasticity of demand, income elasticity of demand usually is a positive coefficient. Except for ‘‘inferior goods,’’ an increase in income is expected to produce an increase in consumption. Whereas movements up and down the demand curve represent the price elasticity of demand, the income elasticity of demand is represented by shifts in the entire demand curve (the price–quantity relationship), as illustrated in Figure 19.8. For lower-income households, usage will be less responsive to changes in price. Discretionary water use by poor households also will be constrained by the lack of income. Therefore, pricing will be a less effective conservation tool. In fact, price increases can cause hardship on households when choices about usage are constrained.

19.5.3

Equity

A fundamental issue in ratemaking is importance of equity relative to efficiency. Efficiency is a fundamental goal, but it is not the only goal of utility pricing. Pricing

Figure 19.8 The role of price and income in consumption. (bold arrow indicates the role of price) (source: USEPA).

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ACHIEVING SUSTAINABLE WATER SYSTEMS

also must help achieve a delicate balance between the interests of the utility and the interests of ratepayers, and in doing so pass the public interest standard. Efficiency is a necessary but not a sufficient element of sustainability. In the long run and on the whole, a sustainable price also must be sufficient to meet quality standards and affordable to water customers within the system’s service territory. Equity considerations arise in part because of the distributional (or redistributional) impacts of policy choices. Markets often are judged in terms of Pareto efficiency, wherein no one can be made better off without making someone else worse off. A more pragmatic and less stringent standard [advanced by Kaldor (1939), and Hicks (1939)] requires only that society overall be better off in terms of efficiency gains, even though a policy option may result in winners and losers. These distributional impacts can be mitigated if the ‘‘losers’’ are somehow compensated (as long as the overall benefits continue to outweigh the overall costs). By implication, the move toward more efficient water rates may have distributional consequences, where low-income households with relatively inelastic usage are made worse off, but it may be possible to lessen the impact through rate adjustments or other methods of assistance while still preserving efficiency gains. Three kinds of equity are particularly relevant in the practice ratemaking: 1. Horizontal equity, which suggests that those who impose similar costs should pay the same rate. A related ratemaking principle is that rates should be ‘‘nondiscriminatory.’’ 2. Vertical equity, which suggests that those who impose different costs should pay different rates that reflect those cost differences. Economic regulation allows for ‘‘due discrimination’’ in ratemaking when costs among customer groups vary substantially. 3. Intergenerational equity, considers equity along a temporal dimension, suggesting that one generation of customers should not be forced to cover costs imposed by another generation. Intergenerational equity can be a particular challenge for water systems because of the very long lifespan expected for most components of water system infrastructure; today’s decisions affect not only current consumers and ratepayers but future consumers and ratepayers as well. Water systems can ‘‘pay as they go’’ and simply increase current rates to cover the amount required to pay for the capital improvement. Alternatively, they can borrow the funds to pay for the system, and make a series of small payments over time to finance the interest due on the debt. Sustainable pricing might cover costs under either approach, regardless of equity implications, although a disproportionate rate burden on one generation of customers may undermine affordability and thus sustainability. A general principle followed in economic regulation and cost allocation is that burdens follow benefits, meaning that the ratepayers who enjoy the use of the water facilities should also provide the compensation for those facilities. The issue is complicated somewhat by assumption regarding the relative wealth of current and

19.6 RATE DESIGN

481

future generations (Rosen 1992). Subsidies can be used to mitigate intergenerational transfers, but not without implications for efficiency. The minimization of subsidies and intergenerational transfers are consistent with the concept of sustainability.

19.5.4

Sustainable Price Characteristics

In sum, the idea of a sustainable price can be very consistent with the principle of marginal-cost pricing (Fig. 19.9). In keeping with marginal-cost pricing theory, a sustainable price avoids underpricing and overpricing and the associated deleterious effects on demand. As summarized in Table 19.3, sustainable pricing has implications for both water utilities and customers. Obviously, a sustainable price is constrained by the conditions of efficiency and affordability. The literature of ratemaking probably provides more guidance on designing rates that are efficient than affordable. Ultimately, the affordability of the rate may depend on considerations outside the normal boundaries of ratemaking and rate design. These considerations include structural options for utilities (including size), as well as methods of assistance that can be provided to low-income households.

19.6

RATE DESIGN

Pricing theory is applied through rate design, which tends to be more art than science. Choices made in the rate design process determine how costs are allocated among customers and whether the revenues from rates will support the true cost of water service. Choices in rate design can result in rates that are more or less efficient and more or less affordable; that is, rate design choices are intrinsically related to sustainability.

Figure 19.9

Marginal-cost pricing and sustainability (source: USEPA).

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TABLE 19.3 Sustainable Pricing Implications for Water Systems

Pricing Underpricing

Overpricing

Sustainable pricing

19.6.1

Jeopardizes financial capacity by reducing revenues Can lead to postponement of necessary expenditures Inflates need for supply Can be politically motivated and difficult to overcome Allows subsidies to other functions or services, or excess profits Enhances financial capacity in the short term Harmful to financial capacity in the longer run by dampening demand and inducing bypass Ensures financial capacity Encourages maintenance of the system over time Facilitates sound decisions about future capacity needs Reduces the need for outside subsidies

Implications for Water Customers More affordable water bills Induces inefficient levels of consumption and shifts costs to future

Less affordable water bills Impairs the quality of life by unnecessarily constraining usage

Should be considered affordable Sends an appropriate price signal, inducing usage based on prices that reflect the cost of service

Principles of Rate Design

Many ratemaking analysts rely substantially on eight criteria Bonbright et al. (1988) and Phillips (1993) have put forth for a sound or desirable rate structure: 1. The related, ‘‘practical’’ attributes of simplicity, understandability, public acceptability, and feasibility of application 2. Freedom from controversies as to proper interpretation 3. Effectiveness in yielding total revenue requirements under the fair-return standard 4. Revenue stability from year to year 5. Stability of the rates themselves, with a minimum of unexpected changes seriously adverse to existing customers 6. Fairness of the specific rates in the appointment of total costs of service among the different consumers 7. Avoidance of ‘‘undue discrimination’’ in rate relationships

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483

8. Efficiency of the rate classes and rate blocks in discouraging wasteful use of service while promoting all justified types and amounts of use: a. In the control of the total amounts of service supplied by the company b. In the control of the relative uses of alternative types of service (on-peak vs. off-peak electricity, Pullman travel vs. coach travel,. single-party telephone service vs. service from a multiparty line, etc.). Bonbright et al. (1988) considered three of the criteria listed above—revenue sufficiency, fairness, and efficiency—to be especially important. Despite the passage of time, these criteria remain quintessential (at least in the regulatory context). Indeed, the idea of sustainable pricing seems highly consistent with this set of evaluation criteria, which includes both efficiency and equity considerations. Several specific rate design options, as discussed below, also pass these tests. In practice, of course, no rate structure is perfect. Ratemaking often requires tradeoffs among competing policy goals.

19.6.2

Cost Allocation

In rate design, the common costs of service are allocated among customers according to the usage patterns. Costs-of-service studies are used for this purpose. Allocating costs within and among classes of customers is a significant step in rate design. Typically, water systems group residential and nonresidential (commercial and industrial) customers for purposes of ratemaking. Meter size is often used to define customers and allocate costs. Another aspect of rate design is the allocation of costs to a fixed or a variable component of the water bill. Some utilities include an initial block of water usage in the fixed charge. As summarized in Table 19.4, different allocations between fixed and variable charges have different advantages and disadvantages. A rate design with a low fixed charge that includes a block of water usage can be very predictable and

TABLE 19.4

Fixed versus Variable Charges

High fixed charges, low variable charges

High variable charges, low fixed charges

Advantages

Disadvantages

Provides water systems with revenue stability and customers with water bill predictability; provides less incentive to encourage consumption Encourages conservation; can be affordable if usage is low

Discourages conservation by customers

Revenue instability, more incentive to encourage usage

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affordable. However, rates that tie the bill to actual usage via variable charges generally are considered more efficient. 19.6.3

Rate Design Options

Alternative types of rates accomplish different goals for water systems. The prevailing types of rates used in the United States are uniform rates (also uniform by class), decreasing block, increasing block, and seasonal (or excess-use) rates. Rates often are designed to address particular policy goals, including affordability and conservation. Some ‘‘progressive’’ rate structures, such as lifeline rates, are specifically designed to keep a basic block of usage affordable for low-income customers. An increasing-block rate structure, for example, charges a higher unit price for higher levels of usage. The rate may be generally applied to all customers. A lifeline rate prices the first block of water usage (perhaps based on an estimate of subsistence requirements) at or below marginal cost. Generally, lifeline rates are provided only to eligible customers according to a demonstration of need (such as eligibility for other assistance programs). Subsequent blocks are priced at higher rates, which will tend to shift costs to higher-use customers (who generally may be better positioned to afford their water bills). Water systems may be tempted, in the interest of affordability, to shift costs from core (residential) customers to large-volume users who appear more capable of paying larger bills. The problem with this strategy is that usage by large nonresidential customers is more price-elastic. A high price might induce industrial customers to cut back usage or even leave the system altogether, which only reduces the customer base over which costs must be spread. In designing sustainable rates, care must be taken to send efficient price signals without inducing harmful bypass. Sustainable water pricing has obvious relevance for water conservation and environmental preservation. A conservation-oriented rate generally is one that sends a clear message to customers about the value of water. An economically efficient rate will communicate water’s marginal cost. Some rate structures that are considered conservation-oriented include uniform volume rates, increasing-block rates, seasonal rates, and excess-use rates (Fig. 19.10). From a rate design perspective, the goals of conservation and affordability are compatible. As illustrated in Figure 19.11, a rate can be designed to incorporate multiple policy goals. In this instance, the rate reflects a lifeline and conservation component. Costs are allocated to higher-end users, who tend to use more water (particularly for more discretionary uses in peak periods), and who also have higher household incomes. Some of the multisystem water utilities in the United States and elsewhere have implemented a rate design strategy known as consolidated rates, equalized rates, or single-tariff pricing. To the extent that consolidated rates promote both long-term efficiency and affordability, they are very consistent with the goals of sustainability. With consolidated rates, the same rate applies to all customers regardless of location and system level costs. Costs are spread over the entire service population so that service to high-cost areas (such as those with a very small customer base) is more

19.6 RATE DESIGN

Figure 19.10

Figure 19.11 USEPA).

485

Conservation-oriented rate design options (source: USEPA).

Sustainable water rate with lifeline and conservation components (source:

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ACHIEVING SUSTAINABLE WATER SYSTEMS

affordable. Consolidated rates have been used directly to mitigate the high cost of serving some areas, particularly areas where the cost impact of standalone rates would be overly burdensome, and to encourage cost-effective consolidation of water systems. Importantly, rate consolidation is a pricing strategy, not a costing strategy. Rate equalization or single-tariff pricing can appear to lower costs when in reality it simply allocates costs differently. In fact, one of the chief benefits of single-tariff pricing is that it greatly simplifies the allocation of common costs across separate facilities. Many water utilities believe that single-tariff pricing is more reflective of the consolidated cost of service. By itself, single-tariff pricing may not provide significant economies of scale because only the costs associated with the pricing process itself (including analytical, administrative, and regulatory costs) can be considered. A primary disadvantage of rate consolidation is that it may appear to undermine economic efficiency by underpricing water in high-cost areas. This effect can be mitigated by varying tail-block rates according to spatial differentials in costs, so that customers who use more water in higher-cost areas will see higher water bills. 19.6.4

Implementation Strategies

As summarized in Table 19.5, water utilities can adopt a number of specific strategies to facilitate sustainability. Most of these strategies center on the utility’s TABLE 19.5 Sustainable Pricing Strategies for Water Systems 1. Establish a long-term plan; pricing and financial planning should go hand in hand with coordinated long-term planning to guide system management, investment, maintenance, and pricing decisions 2. Know your system’s true costs; knowing the true cost of water service is at the heart of sustainable water pricing. Identifying true costs is a challenge for many water systems. 3. Understand the cost-price-demand linkage; pricing obviously will determine whether revenues will cover costs, but pricing also will influence demand patterns over the long term 4. Send accurate price signals; prices that reflect cost induce sustainable levels of supply and demand 5. Practice goal-oriented pricing; making sustainability (efficiency and affordability) an explicit ratemaking goal will facilitate the development of effective rate structures 6. Communicate with customers; water systems rely on well-informed customers— customer support for pricing choices is essential 7. Work with oversight bodies; many systems are accountable to local or state governmental authorities, which may place particular requirements on the rate design process 8. Monitor costs and revenues; some rate designs introduce more uncertainty into the system’s revenue profile—monitoring can help identify issues that require attention 9. Make needed adjustments; no rate structure will produce theoretical results—adjustments will move systems closer to goals over time 10. Explore new approaches; modern water systems can explore an expanding range of rate design options, many of which are very consistent with sustainability goals

19.7 FUTURE TRENDS IN ACHIEVING SUSTAINABILITY

TABLE 19.6 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17.

487

Sustainability Pricing Strategies for Regulators

Understand key cost drivers Allow timely recovery of legitimate costs Consider alternative pricing approaches (allow experimentation) Avoid politicizing the ratemaking process Require cost justification and consideration of least-cost solutions Encourage integrative long-term planning Provide incentives for strategic pricing and planning Promote forward-looking pricing Recognize price effects on demand and revenues Address affordability issues Recognize necessary tradeoffs in pricing Establish uniform systems of accounts Use accounts that are consistent with pricing goals Justify costs through appropriate means Understand that correct pricing requires resources Understand that pricing is both art and science Be flexible and open to experimentation

knowledge about costs and alternative cost management strategies. Utilities that are regulated by state commissions and other oversight boards might need approval to change rates or rate structures. Price regulators also may need to implement some strategies related to sustainability, as summarized in Table 19.6. A deliberate effort toward sustainability is a worthy goal for water systems, as well as for society as a whole. Sustainable systems are, by definition, more efficient and more effective in meeting performance goals. External subsidization of water systems may be needed in the short term, but should be avoided for the long term without a compelling rationale. For many water systems, achieving sustainability is a long-term process. No one formula will suit the needs of every water system or community. The key to implementation lies less in the particular approach than in the commitment to the goals of sustainability and an understanding of how pricing can help achieve these goals.

19.7

FUTURE TRENDS IN ACHIEVING SUSTAINABILITY

Compliance with future SDWA regulations will continue to exert pressure on financial resources of water systems of all sizes. In addition, water systems will be faced with needed improvements as a result of aging infrastructure and congressionally mandated vulnerability assessments to ensure water system security. Sustainable water pricing is essential for ensuring water system financial, technical, and managerial capacities. To be a sustainable water system—one that is financially self-sufficient—the system must rely primarily, if not exclusively, on revenues from water rates to pay

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for all capital and operating needs. External subsidies should be used only in the short term to help the system achieve financial capacity and self-sufficiency. Internal subsidies or funding from revenue sources other than rates and charges to water customers should be kept to a minimum. Shifting costs to future generations should be avoided. Water systems must periodically reassess their rate structure and strive to operate at a sustainable price—one that will generate sufficient revenues to ensure the sustainability of the water system itself, meeting all service obligations in their entirety, including infrastructure adequacy as well as SDWA compliance.

ACKNOWLEDGMENTS This chapter is based on research supported by the USEPA, although the content and views are solely those of the author. The author acknowledges the contribution of Peter Shanaghan, USEPA OGWDW, and Dr. Richard A. Krop, The Cadmus Group, to the initial USEPA-funded research.

REFERENCES Agthe, D. E., and B. Billings. 1987. Equity, price elasticity, and household income under increasing block rates for water. Am. J. Econ. Sociol. 46:273–286. AWWA. 1986. Water Rates and Related Charges. Denver: American Water Works Association. AWWA. 1996. Managing the Revenue and Cash Flow Effects of Conservation. Denver: American Water Works Association. Beecher, J. A., P. C. Mann, Y. Hegazy, and J. D. Stanford. 1994. Revenue Effects of Water Conservation and Conservation Pricing: Issues and Practices. Columbus, OH: National Regulatory Research Institute. Beecher, J. A., and P. C. Mann. 1996. The role of price in water conservation evidence and issues. Proc. Conserv96: Responsible Water Stewardship. Denver: American Water Works Association. Beecher, J. A., P. C. Mann, and J. R. Landers. 1990. Cost Allocation and Rate Design for Water Utilities. Columbus, OH: National Regulatory Research Institute. Beecher Policy Research, Inc. 1999. Sustainable Water Pricing: A Long-Term CapacityDevelopment Strategy. Working Papers on Small System Implementation. Washington, DC: USEPA Office of Water. Bhatt, N. R. and C. A. Cole. 1985. Impact of conservation on rates and operating costs. J. Water Resources Plan. Manage. 111:192–206. Bonbright, J. C., A. L. Danielsen, and D. R. Kamerschen. 1988. Principles of Public Utility Rates, 2nd ed. Arlington, VA: Public Utility Reports. California Department of Water Resources. 1988. Water Conservation Guidebook No. 9— Guidebook on Conservation-Oriented Water Rates. Sacramento: State of California Dept. Water Resources. California Urban Water Conservation Council. 1996. Handbook for the Design, Evaluation, and Implementation of Conservation Rate Structures. (Prepared by Thomas W. Chesnutt,

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A&N Technical Services, et al.) Los Angeles: Californian Urban Water Conservation Council. Caswell, M., E. Lichtenberg, and D. Zilberman. 1990. Effects of pricing policies on water conservation and drainage. Am. J. Agric. Econ. 72:883–890. Chestnutt, T. W., C. McSpadden, and J. Christianson. 1996. Revenue instability induced by conservation rates. J. Am. Water Works Assoc. 88:52–63. Chesnutt, T. W., J. Christianson, A. Bamezai, C. N. McSpadden, and W. M. Hanemann. 1995. Revenue Instability and Conservation Rate Structures. Denver: American Water Works Association. Chicone, D. L., S. C. Deller, and G. Ramamurthy. 1986. Water demand estimation under block pricing: A simultaneous equation approach. Water Resources Research 22:859–863. Comer, D. and R. Beilock. 1982. How rate structures and elasticities affect water consumption. J. Am. Water Works Assoc. 74:192–206. Cuthbert, R. W. 1989. Effectiveness of conservation-oriented water rates in Tucson. J. Am. Water Works Assoc. 81:65–73. Deming, J. L. 1992. Establishing an income based discount program. J. New Engl. Water Works Assoc. 106:203–205. Farnkopf, J. W. 1996. Dissecting rate structures: Identifying where further refinements are warranted. Proc. Conserv96: Responsible Water Stewardship. Denver: American Water Works Association. Fox, T. P. 1996. Analysis, design and implementation of a conservation rate structure. Proc. Conserv96: Responsible Water Stewardship. Denver: American Water Works Association. Griffith, F. P. 1984. Peak use charge: An equitable approach to charging for and=or reducing summer peak use. Can. Water Resources J. 9:17–21. Hasson, D. S. and D. G. Ovard. 1987. Using peaking factors to update water rates. J. Am. Water Works Assoc. 79:46–51. Hicks, J. R. 1939. The foundations of welfare economics. Econ. J. 49:696. Kaldor, N. 1939. Welfare propositions of economics and interpersonal comparisons of utility. Econ. J. 49:549. Mann, P. C. and D.M. Clark. 1993. Marginal-cost pricing: Its role in conservation. J. Am. Water Works Assoc. 85:71–78. Martin, W. E., H. M. Ingram, H. K. Laney, and A. H. Griffin. 1994. Saving Water in a Desert City. Washington, DC: Resources for the Future. Martin, W. E., and S. Kulakowski. 1991. Water price as a policy variable in managing urban water uses: Tucson, Arizona. Water Resources Research 27:157–166. McNeill, R. and D. Tate. 1991. Guidelines for Municipal Water Pricing. Social Science Series 25. Ottawa: Environment Canada. Mui, B. G., K. W. Richardson, and J. F. Shannon. 1991. What water utility managers should know about developing water rates. Water Eng. Manage. 138:18–20. Nieswiadomy, M. L. 1992. Estimating urban residential water demand: Effects of price structure, conservation, and education. Water Resources Research 28:609–615. Ozog, M. T. 1996. Price elasticity and net lost revenue. Proc. Conserv96: Responsible Water Stewardship. Denver: American Water Works Association. Phillips, C. F., Jr. 1993. The Regulation of Public Utilities. Theory and Practice. Arlington, VA: Public Utilities Reports.

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Renshaw, E. F. 1982. Conserving water through pricing. J. Am. Water Works Assoc. 74(1):2–5. Rosen, H. S. 1992. Public Finance. Homewood, IL: Richard D. Irwin, Inc., p. 455. Sang, W. H. 1982. The Financial Impact of Water Rate Changes. J. Am. Water Works Assoc. 74:466–469. Schlette, T. C. and D. C. Kemp. 1991. Setting rates to encourage water conservation. Water Eng. Manage. 138:25–29. U.S. Bureau of Reclamation. 1997. Incentive Pricing Handbook for Agricultural Districts. Washington, DC: Bureau of Reclamation, U.S. Department of the Interior. Prepared by Hydrosphere Resource Consultants. Available online at http://209.21.0.235/documents/ index.htm. U.S. Bureau of Reclamation. 1998. Incentive Pricing Best Management Practice for Agricultural Irrigation Districts. Washington, DC: Bureau of Reclamation, U.S. Department of the Interior, http://209.21.0.235/documents/index.htm. USEPA. 1998a. Information for States on Developing Affordability Criteria for Drinking Water. EPA 816-R-98-002. Washington, DC: Office of Water. USEPA. 1998b. Information for States on Implementing the Capacity Development Provisions of the Safe Drinking Water Act Amendments of 1996. EPA 816-R-98-008. Washington, DC: Office of Water. USEPA. 1998c. National-Level Affordability Criteria under the 1996 Amendments to the Safe Drinking Water Act. Washington, DC: Office of Ground Water and Drinking Water. USEPA. 1998d. Water Conservation Plan Guidelines. Washington, DC: Office of Waste Water. USEPA. 1998e. Variance Technology Findings for Contaminants Regulated before 1996. EPA 815-R-98-003. Washington, DC: Office of Water. USEPA. 1999. Consolidated Water Rates: Issues and Practices in Single-Tariff Pricing. EPA 816-R-99-009. Washington, DC: Office of Water.

20 PROTECTING SENSITIVE SUBPOPULATIONS JEFFREY K. GRIFFITHS, M.D., M.P.H., T.M. Director of the Graduate Programs in Public Health, Tufts University School of Medicine, Boston, Massachusetts

20.1

INTRODUCTION

All people, no matter their personal beliefs, customs, or health, move in and out of being in a sensitive subpopulation through the normal life cycle. The 1996 amendments to the Safe Drinking Water Act (SDWA) require the U.S. Environmental Protection Agency (USEPA) to consider susceptible subpopulations when making health risk assessments. These legal requirements are only one manifestation of the general societal concern that exists around protecting infants and children, the elderly, and people with impaired health or unusual health risks. This chapter presents basic concepts on what constitutes a sensitive subpopulation and their protection under the SDWA. While much of this discussion is most pertinent to the United States, the same population trends are occurring in most other countries, and the concepts discussed in this chapter are universal in nature and application.

20.2

DEFINING SENSITIVE SUBPOPULATIONS

A sensitive subpopulation is one that is at increased risk of some adverse health event or outcome after exposure to a contaminant in drinking water. Increased risk in this case is defined as an increase when compared to the total general population. An ‘‘adverse event or outcome’’ is generally a medical or health-related outcome. This broad definition does not prejudge or restrict the reason(s) for the sensitivity, but Drinking Water Regulation and Health, Edited by Frederick W. Pontius. ISBN 0-471-41554-5 # 2003 John Wiley & Sons, Inc.

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does focus on the health effects of the sensitivity. A broad definition is appropriate because drinking water treatment and regulation is focused on protecting the health of the population. The Agency for Toxic Substances Diseases Registry (ATSDR, a division of the Centers for Disease Control) uses a toxicological definition for sensitive subpopulation: A susceptible subgroup exhibits a response that is different or enhanced when compared to the responses of most people exposed to the same level of the contaminant. The key concept is that the sensitive subpopulation is affected when some other group (e.g., the rest of the population, or the total population) is not, or is affected to a lesser extent. Indeed, in its December 2000 report to Congress (USEPA 2000), USEPA used this definition: Sensitive subpopulations are defined in this report as groups of individuals who respond biologically at lower levels of exposure to a contaminant in drinking water or who have more serious health consequences than the general population. This definition also includes those individuals who have a greater level of exposure than the general population as a consequence of biological factors that are characteristic of the group to which they belong.

Note that the common elements of ‘‘lower levels of exposure still lead to disease’’ and ‘‘more serious consequences in the subpopulation’’ are common definitional threads. USEPA commissioned a workshop on definitions and research needs, and more detailed discussions about how susceptibility is defined are available in reports on the workshop (Balbus et al. 2000, Parkins and Balbus 2000).

20.3

SENSITIVE SUBPOPULATIONS AND THE SDWA

Attention is currently being given to sensitive subpopulations for at least two reasons: (1) anyone who is providing water to the public would legitimately want to provide a safe and wholesome product—knowledge that some groups of people might get sick from tapwater is worrisome and provokes interest in preventing adverse effects, and (2) USEPA is legally required by the 1996 SDWA reauthorization to consider the health effects of drinking water contaminants and treatment on the total population and on sensitive subpopulations, and to seek their input. Key portions of the 1996 SDWA are quoted below [SDWA Sec. 1412(b)(3)(C), emphasis added]: When proposing any national primary drinking water regulation that includes a maximum contaminant level, the Administrator shall . . . publish, seek public comment on, and use . . . an analysis of . . . the quality and extent of, the information, the uncertainties in the analysis supporting subclauses (I) through (VI) [quantifiable and nonquantifiable health risk reduction, quantifiable and nonquantifiable costs, incremental costs and benefits associated with each alternative maximum contaminant level considered, effects of the contaminant on general population and sensitive subpopulation, increased health risk as the result of compliance, including risks associated with co-occurring contaminants] and factors with respect to the degree and nature of the risk.

20.4 IDENTIFYING SENSITIVE SUBPOPULATIONS

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Then [SDWA Sec. 1458(d)(2), emphasis added] The Director and the Administrator shall jointly establish a national health care provider training and public education campaign to inform both the professional health care provider community and the general public about waterborne disease . . . shall seek comment from interested groups and individuals . . . scientists, physicians, state & local governments, environmental groups, public water systems, and vulnerable populations.

Importantly, the setting of drinking water maximum contaminant levels requires the consideration of sensitive populations. Regulatory and legal attention to subpopulations is grounded in the longstanding recognition that some groups of people, such as infants and children, pregnant and lactating women, and the elderly are more susceptible to some illnesses. USEPA has independently identified children as a subpopulation that will receive additional focus, and has established the Office of Children’s Health Protection to coordinate these efforts (USEPA 1999).

20.4

IDENTIFYING SENSITIVE SUBPOPULATIONS

Sensitive subpopulations include commonly understood groups as well as newly recognized groups. Babies, young children, pregnant women, and the elderly are the obvious examples of sensitive populations that are within everyone’s commonsense experience. Their ability to fight off infections is well known to be lower than that of the general population. The ‘‘frail’’ elderly, those with some chronic illnesses or who have suffered the effects of some prior illnesses, are particularly sensitive when compared to the ‘‘well’’ elderly, who are otherwise hale and hearty. For example, several studies have shown that the annual incidence of infections in the elderly living in long-term care facilities (such as nursing homes) is up to 4 times higher than in the elderly who are living in the community (Garibaldi et al. 1981, Ruben et al. 1995, Ryan et al. 1997). Similarly, people with AIDS or people receiving chemotherapy for cancers are well known to have reduced immunity. People who have undergone a transplantation (e.g., of the kidney, liver, heart, or bone marrow) are also at increased risk of infections. Some groups, such as pregnant women and infants, are also more sensitive to the effects of nitrates, which causes specific metabolic problems. Traditionally, risk in the population has been viewed as being high during the extremes of life, such as infancy and old age. While true, this view of susceptibility is outdated and does not reflect the realities of modern life. People are living longer, and the proportion of the population that is elderly is rapidly expanding. Indeed, the fastest-growing population segment is that population over 85 years of age. Figure 20.1 (U.S. Census Bureau, International Data Base) provide snapshots of the breakdowns of the U.S. population in 1975 and in 2025. This ‘‘population pyramid’’ shows that young children and adolescents represented a far larger part of the population than the elderly in 1975. This reflects increasingly

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Figure 20.1 U.S. demographic picture in 1975 and 2025. Top: demographic snapshot 1975—classic triangular shape with many more children than adults. Bottom: projected demographic profile of the United States, 2025—‘‘house’’ shape with straight sides up to age 70. Everyone above the diagonal lines are people who will be alive in 2025, but who would not have been had they been born 50 years earlier. (source: U.S. Census Bureau, International Data Base.)

higher death rates as people age, starting in childhood. However, over time, the population will become (on average) older. As illustrated, most people will survive to age
70 in the 2025 projection. This trend is particularly true in many Central and Western states, and in rural areas, which many young adults have migrated away from in search of work. In general, people are living longer with more chronic illnesses. Public health and medical advances have led to an increased lifespan in the United States. Lifespan in 1900 was about 40 years of age; it is currently
75. People are living with chronic heart, lung, kidney, and liver diseases, and metabolic ones such as diabetes. Both asthma and diabetes are increasing at epidemic rates in the United States. These chronic illnesses, along with many others, increase a person’s susceptibility to health insults. This has led to the recognition that the population includes the ‘‘well’’ elderly and the ‘‘frail’’ elderly, with remarkably different sensitivities. For example, people with tenuously balanced heart failure may need to be hospitalized when they develop gastroenteritis, while people with normal heart function would not. Thus, an updated view of susceptibility in the general population should reflect these changes in the population. In Figure 20.2, the recognition of increased susceptibility to contaminants in infants and the elderly in the traditional view (top) is updated to reflect our modern knowledge (bottom) about risks during pregnancy and during a ‘‘frail’’ old age. From this realization, an important central conclusion can be reached. All people move in and out of being part of a ‘‘sensitive’’ subpopulation. Everyone is an infant, and barring accidental death or bad luck, everyone becomes old; half of the population is female, and therefore likely to undergo pregnancy. Before our demise, many of us will be ill with a number of chronic ailments, some of which may render us frail and more susceptible to adverse health events. Anyone who is not currently in a sensitive subpopulation is at significant risk of joining one in the future.

20.5 WHAT MAKES A PERSON OR POPULATION SENSITIVE?

Figure 20.2 Populations.

20.5

495

Traditional view (top) and modern view (bottom) of risk to Sensitive

WHAT MAKES A PERSON OR POPULATION SENSITIVE?

A variety of factors can cause some people to be more sensitive than the general population. This discussion has been grouped into three main areas: people suffering cancer or adverse reproductive consequences, infections, and other factors.

20.5.1

Cancer or Adverse Reproductive Consequences

Cancers arise when the deoxyribonucleic acid (DNA) of the cell (the blueprint) is damaged by a chemical, leading to a loss of control over cell multiplication. Once this control is lost, the now-malignant cell is free to continue growing without hindrance. Many scientists believe that several DNA damaging events (‘‘multiple hits’’) may need to occur before an actual malignancy will occur. People exposed to high levels of carcinogens in drinking water for a short period of time may develop cancer, as may people exposed to low levels for prolonged periods. People who have already suffered a number of DNA damaging events may be a sensitive subpopulation. For example, people who have already had one cancer (and who can be presumed to have had DNA-damaging events) are at much higher risk of developing another cancer than are people who have never had one. Finally, some people may be born with the genetic disposition to cancer, as these may ‘‘run in families,’’ and fewer external insults to a person’s DNA may be needed to lead to a malignancy. Breast cancer is a common example. Pregnant women, infants, and children have cells that undergoing rapid division and growth, and thus they are especially susceptible to agents that can damage DNA. Cells are most susceptible to suffering damage when they are actively dividing and growing (their DNA is physically more exposed during this period). For example, some waterborne contaminants can affect reproductive integrity, such as causing sterility or decreased sperm potency in men. This occurs because the reproductive cells (in this case, the cells that form sperm) are actively multiplying and producing a continuous supply of sperm. Similarly, some contaminants cause women to miscarry, because the fetus’ rapidly dividing cells are damaged, and the remaining cells either are nonviable or do not grow and divide properly (a ‘‘lethal mutation’’). The fetus can suffer significant adverse harm from some contaminants, such as neurotoxicity

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from methyl mercury in fish that the mother has eaten, without fetal death (Mahaffey 2000). The common thread that ties these forms of adverse health effects together is that they result from damage to DNA, the blueprint of the cell. Sometimes this damage causes the cell to die, or it causes the cell to grow without control. Thus, the sensitive subpopulations for this group of contaminants include people with many growing and dividing cells (pregnant women because of the fetus they are carrying, infants, and children). Cancer is the second most common cause of death in the United States, after cardiovascular diseases (heart attacks, strokes, hypertension, etc.) (Ries et al. 2000, Howe et al. 2001). The National Cancer Institute estimated in 1996 that approximately 8.2 million Americans alive today have an history of cancer. One of every four deaths in the United States is from cancer, totaling 539,000 in 1996. About 1.2 million cases of nonskin cancer are diagnosed each year, and about 1.3 million cases of skin cancer. Cancer mortality is distributed across the United States, and in many states there is no particular rural–urban pattern. Historically, cancer was clustered near large urban industrial centers, but this no longer holds. Figure 20.3 presents total cancer death rates for white women by county during the period 1970–1974. Death rates, not incidence rates, were chosen for this map since some cancers, such as skin cancers, do not lead to significant illness, subpopulation sensitivity,

Figure 20.3 Total cancer death rates for white women by county (age-adjusted 1970 U.S. population) during the period 1970–1974. This map was created using the National Cancer Institute’s On-Line Atlas, which can be found at www.nci.nih.gov/atlasplus/.

20.5 WHAT MAKES A PERSON OR POPULATION SENSITIVE?

497

or death (National Cancer Institute 1999). Note the scatter of red high cancer counties distributed through the Midwest and the Rocky Mountain states. 20.5.2

Infections

One of the great public health advances of the twentieth century was the move to provide the population with clean potable water. These measures led to major decreases in the burden of infectious diseases in the U.S. population (Okun 1999). These measures predated antibiotics and most vaccines; indeed, many people forget that the huge decrease in infectious diseases in the United States earlier in the twentieth century was due to clean water, clean food, and sewerage—not to modern medical advances. The failure of drinking water treatment, such as occurred in Walkerton, Canada, in 2000 led to many thousands of ill people and over a dozen deaths (the exact numbers are in dispute). Thus, even in advanced societies continuing water treatment is absolutely crucial. The thousands of infectious agents that exist generally fall into three groups: viruses, bacteria, and parasites, in order of increasing complexity. Many of these agents can be transmitted by contaminated drinking water. Water treatment kills, inactivates, or removes the vast majority of these pathogens. Parasites are generally more difficult to inactivate with standard disinfection than either viruses or bacteria, and in fact some (e.g., Cryptosporidium) cannot be killed with standard chlorination. Although it is presumed that groundwater systems are very unlikely to be contaminated with infectious agents because of the filtering performed by the ground, many outbreaks have occurred in groundwater systems because of wellhead contamination or distribution system flaws. Ultraviolet light appears to be effective against all three of these groups of pathogens. Sensitive populations can be unusually sensitive to any of these agents. Prions (associated with ‘‘mad cow disease’’ and scrapie, a sheep disease) are believed to be a new or fourth class of infectious agents, have never been shown to be transmitted in water, and are not currently of any significant public health or scientific concern regarding water. Infants, because of their small size and naive immune systems, are well known to be especially sensitive to infectious diseases. Being small means that they are easily overwhelmed, and being naive means that their immune systems do not know how to effectively fight off many infections. Young children are less sensitive than infants, but still more sensitive than older children, adolescents, and adults. Pregnant women are also relatively immunocompromised, and have been repeatedly shown to suffer more frequent and more severe infections than women who are not pregnant. Many of these infections can be devastating to the fetus, and can lead to stillbirths, miscarriages, and congenital anomalies. The elderly have less robust immune systems than do younger adults overall (Ben-Yehund and Weksler 1992). Several circumstances render them even more susceptible to infections: (1) if they are frail with chronic diseases, (2) if they have undergone chemotherapy for a malignancy (this is true for all age ranges), or (3) if they have a malignancy (again, this is true of all age ranges). People with AIDS, people who take immunosuppressive drugs (such as steroids), and people who have had transplantation are at elevated risk for infec-

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tion. Finally, diabetes—another epidemic disease in the United States—also has a negative impact on immunity, and infections are common in this group.

20.5.3

People with AIDS

People with AIDS are first infected with HIV, pass a variable period of time infected but not yet damaged by the virus, and then enter a period of profound susceptibility to infections (AIDS) after their immune systems have weakened. If they are not treated with one of the modern ‘‘cocktails’’ of drugs that suppress the virus infection, they usually die of infections. How many people have AIDS, and where do they live? Figure 20.4 shows the total number of prevalent cases of AIDS in the United States. As AIDS death rates have gone down with modern treatment (the light line), and as HIV positive people have not advanced to AIDS as quickly as in the past (medium line), the total number of people with AIDS has steadily increased (dark line) (CDC 2001c–2001e). Figure 20.4 shows only people who have the HIV virus but who do not have AIDS yet. In general, double the number of cases of AIDS to approximate the number of people who have HIV but have not yet developed AIDS. Figure 20.5 shows AIDS rates by state (again, double to include people with HIV). What about where people with AIDS live, such as any rural–urban difference, or by state of residence? (Again, double the rates quoted below to include people with HIV). Table 20.1 presents adult=adolescent AIDS cases by size of place of residence, reported in 1999 and cumulative, United States (excluding Puerto Rico, U.S. Virgin Islands, and Territories). Clearly, rural (‘‘nonmetropolitan’’) areas have a lower rate of AIDS than do urban areas (about a fourth), but some states, especially in the Southeast, have high rural rates of AIDS (see Table 20.2). In the late 1980s or early 1990s, on average only a few people with AIDS resided in rural communities, this is no longer the case.

Figure 20.4 Estimated incidents of AIDS, deaths, and prevalence by quarter-year of diagnosis=death in the United States during 1985–1999 (adjusted for reporting delays).

499

20.5 WHAT MAKES A PERSON OR POPULATION SENSITIVE?

Figure 20.5 AIDS rates ( per 100,000 population) by state (double to include HIV-positive people) reported in 1999.

TABLE 20.1 Adult=Adolescent AIDS Cases by Size of Place of Residence, Reported in 1999 and Cumulative, United States (excluding Puerto Rico, U.S. Virgin Islands, and Territories) 1999

1981–1999

Size and Place of Residence

Number

Rate per 100,000

Number

>500,000 50,000–500,000 Nonmetropolitan area

36,525 4,594 3,269

26.6 12.0 7.4

593,859 63,382 40,251

Source: Data from CDC (2000c).

Table 20.2 presents AIDS cases by region and size of place of residence reported in 1999, in the United States. In 1999, most AIDS cases were reported from the South or the Northeast. Within each region, most cases are reported from large metropolitan areas with population >500,000. States in the North Central region TABLE 20.2 AIDS Cases by Region and Size of Place of Residence Reported in 1999, United States

Northeast N ¼ 14,006 (%) North central N ¼ 4.337 (%) South N ¼ 18,770 (%) West N ¼ 7,887 (%) Source: Data from CDC (2000c).

>500,000 Population

50,000–500,000

<50,000

91.1 79.3 71.6 90.0

5.8 11.8 15.0 6.2

3.0 8.7 11.7 3.8

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TABLE 20.3 People Living in the United States with AIDS, by Region of Residence and Year, 1993 through 1999 Region of Residence Northeast Midwest South West U.S. territories Total

1993

1994

1995

1996

1997

1998

1999

51,920 18,479 58,857 39,457 5,742

59,545 20,398 68,148 43,031 6,351

66,433 21,896 75,635 46,024 6,807

73,674 23,764 85,663 49,739 7,344

81,865 26,211 97,376 54,664 8,126

88,867 28,310 108,528 59,164 8,833

97,200 30,722 119,326 63,699 9,332

174,475

197,471

216,796

240,184

268,242

293,702

320,282

and the South reported the highest proportion of cases from smaller metropolitan areas, and the majority of persons reported from nonmetropolitan rural areas (<50,000) reside in the South. Table 20.3 presents the numbers of people living with AIDS, by region of residence and year, during 1993 through 1999, in the United States. The estimated number of people living with AIDS is increasing in every region of the country, as can be seen in Table 20.3. During 1993–1999, this number increased by 83.57% (CDC 2000a). Finally, the CDC has estimated the total number of people living with AIDS in ‘‘nonmetropolitan’’ areas, which can act as a reasonable surrogate for rural areas, to be 20,979 as of September 2000 (CDC 2000b). This definition uses a cutoff point of the place of residence having <50,000 people. Of this total, 15,350 people are aged 35–64, 4994 are aged 19–34, 374 are 65 years of age, 88 are teenagers, and 172 are children under the age of 13.

20.5.4

Transplantation

Solid-organ and bone marrow transplantations have become increasingly common. According to the International Bone Marrow Transplant Registry’s (IBMTR) Spring 2000 ‘‘State of the Art’’ Report, approximately 47,000 bone marrow transplants were performed in 1998, of which 28,000 were performed in North America. The United Network for Organ Sharing has published on its Website (www.unos.org) the data in Table 20.4 regarding solid-organ transplants performed in the year 2000. Given the rising number performed each year, a rough estimate of 50,000 transplantations per year is a reasonable figure. People who have undergone transplantation are often required to continue very significant immunosuppressive therapy for the rest of their lives. Median survival times for these individuals is increasing, and for solid organs may be as high as 80% at 5 years. This suggests that the total number of people living in the United States after transplantation may be several hundreds of thousands of people, perhaps a half

20.5 WHAT MAKES A PERSON OR POPULATION SENSITIVE?

501

TABLE 20.4 Solid-Organ Transplants Performed in the Year 2000 (United Network for Organ Sharing, www.unos.org) Type of Transplant (U.S. data only)

Number

Kidney alone transplants (4457 were living donors) Liver transplants Pancreas alone transplants Kidney–pancreas transplants Intestine transplants Heart transplants Heart–lung transplants Lung transplants

13,372

Total

22,953

4,954 435 911 79 2,198 48 956

million total. Secure estimates for the total number of transplantation survivors are not available. The geographic distribution of transplant recipients is not known. It is reasonable to assume that some proportion do live in rural areas.

20.5.5

Chemotherapy

Chemotherapy is a well-known risk factor for infectious diseases, and chemotherapy damages the lungs, kidneys, liver, and other organs. It also damages normal cells as well as the malignant cells that it targets, so it also elevates the risk for subsequent cancers. People who are undergoing chemotherapy often have severely reduced immunity. Fortunately, this reduced immunity is usually time-limited, so that the immune system tends to recover after the chemotherapy is over. Because the population is aging, both the incidence of cancer and the likelihood of needing chemotherapy are elevated compared to the past. Cancer is the second leading cause of death in the United States, and because most people with a treatable cancer do undergo chemotherapy, chemotherapy is a common event. Exact estimates for the total number of people who undergo chemotherapy, and their site of residence, are not available. However, given that there are about 540,000 deaths from cancer every year, and
1.2 million cases of nonskin cancer diagnosed each year, it is likely that about 1 million people begin chemotherapy each year, and about 45% of all those diagnosed with cancer will eventually die of it (Howe et al. 2001).

20.5.6

Immunosuppressive Therapy

A number of medical illnesses are treated by quieting the immune response. Examples include arthritis, systemic lupus erythematosis, inflammatory bowel disease, and

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Figure 20.6 Estimated average prevalence rates ( per 1000 population) of self-reported asthma for persons aged 5–34 years, by region and year, United States, National Health Interview Survey, 1980–1994.

asthma. Rheumatoid arthritis and asthma are quite common—the former in adults, the latter in children—and all of the abovementioned diseases are often treated with steroids, which indiscriminantly decrease immune function. Rhematoid arthritis is also now treated with more advanced immunosuppressive agents. Asthma is now considered to be epidemic in the United States. Figure 20.6 presents the estimated average prevalence rates of self-reported asthma for persons aged 5–34 years, by region and year, in the United States. Between 1980 and the late 1990s, asthma incidence more than doubled in the United States, and is now reported in more than 5% of the total population. The first line of therapy for most individuals includes bronchodilators, and then inhaled steroids. While most people with asthma do not undergo immunosuppression because of inhaled steroids, the sheer number of people who must use these agents is very large, and a proportion are immunocompromised.

20.5.7

Diabetes

Diabetes, like asthma, is now considered epidemic in the United States. Figure 20.7 presents the number of people in the United States with diagnosed diabetes. Approximately 800,000 new cases are diagnosed each year in the United States. Diabetes directly affects the ability of the immune system to combat infections. 80% of all men in the United States are either ‘‘overweight’’ or ‘‘obese’’ according to CDC criteria. While only 0.16% of people under the age of 20 have diabetes, 8.2%

20.5 WHAT MAKES A PERSON OR POPULATION SENSITIVE?

503

Figure 20.7 Number of people in the United States with diagnosed diabetes. In 1997, 10.3 million people in the United States, had diagnosed diabetes, representing a sixfold increase during the past four decades (at the time of writing). Data from the American Diabetes Association. (source: F. W. Pontius.)

of those between 20 and 65 have the disease, and 18.4% of those aged 65 or older have diabetes (CDC 1998). Deaths from pneumonia and influenza are much more common in diabetics than in those without diabetes. Diabetes also increases the risk of heart disease, stroke, hypertenison, blindness, kidney disease, nervous system damage, amputations, and dental disease. In 1995, 98,872 people with diabetes had to begin dialysis or undergo kidney transplantation, and about 67,000 amputations (because of untreatable infection or dry gangrene) were conducted.

20.5.8

Sensitivity to Exposure

Some groups are sensitive because their existing disease can be exacerbated by an exposure. Other adverse consequences (that are not cancer or other malignancies) include effects such as hypertension, and heart disease. For example, lead poisoning causes children to be anemic and decreases IQ, and causes adults to be hypertensive. Some heavy metals have particular actions on the heart, kidney, or liver. For a substance such as lead, a group that is particularly ‘‘susceptible’’ to the effects of the lead would include children or women who are already marginally anemic, or adult men with marginal hypertension. To give another example, arsenic is detoxified by both the kidneys and the liver. People with preexisting diseases (kidney or liver disease) or with congenital defects (e.g., a single kidney instead of two) will be at greater risk from a toxin that damages those organs or that relies on that organ for detoxification. A sensitive subpopulation for a toxin that damages the heart would be a group with preexisting heart disease, for whom any additional cardiotoxic exposure might throw them into heart failure or rhythm irregularity.

504

20.5.9

PROTECTING SENSITIVE SUBPOPULATIONS

Genetic Predisposition

Some groups have a genetic predisposition. For reasons that are not well understood, some people develop specific diseases more frequently than do other people simply on the basis of their genetic background. For example, hypertension is more common in blacks, diabetes is very common in Native Americans of the Pima tribe, cholera is more severe in people who are blood group O–positive, and gallbladder disease is more common in women than men. It is reasonable to attribute this to differences in our genetic makeup. It is also reasonable to believe that these genetic differences will make some people more susceptible to the effects of some waterborne contaminants. Many toxins are rendered harmless by specific enzymes in our bodies, and the degree to which these enzymes are present is a direct function of our genetic background and the extent to which our bodies are using these enzymes. Given the revolution now occurring in our understanding of the genetic makeup of humans, other animals, and bacteria, it is very likely that in a few years medical scientists will be able to state with assurance that people with a specific gene, or set of genes, are at increased risk of an untoward consequence after exposure to a disease or contaminant that may be found in water. For example, we already know that women with the brac gene are at very high risk of breast cancer, whites are at elevated risk of cystic fibrosis if they carry specific genes, and Native Americans lack certain genes that allow for the rapid detoxication of alcohol. The explosion of knowledge in this area is likely to lead to many more identified groups of people who are unusually sensitive or susceptible to chemical, heavy metal, or pathogenic water contaminants. The National Research Council, a constituent of the National Academies of Science, has published its report entitled Classifying Drinking Water Contaminants for Regulatory Consideration (NRC 2001). In its report The committee recommends that the list of vulnerable subpopulations described in the amended SDWA [Safe Drinking Water Act] should not be seen as a minimum list, but rather as several examples of possible vulnerable subpopulations. A minimum list must go much further than this. In this regard, the EPA should consider . . . women of childbearing age, fetuses, the immunocompromised, people whose genetic disposition makes them more vulnerable to drinking water contaminants, people who are exceptionally sensitive to an array of chemical contaminants, people with specific medical conditions that make them more susceptible, and people with poor nutrition. As scientific knowledge about the determinants of susceptibility expands, our ability to identify vulnerable subpopulations will improve.

The Committee on Drinking Water Contaminants then went on to state that ‘‘The need to protect vulnerable subpopulations is not only legally mandated by the amended SDWA, but also justified on equity and environmental justice grounds.’’ The reports note that the actual definitions of who is in a sensitive subpopulation will not be solely decided by scientific findings, but also on societal values and on viable, democratic means of resolving policy dilemmas.

20.6 WHICH SUBPOPULATIONS ARE OF CONCERN

505

20.6 WHICH SENSITIVE SUBPOPULATIONS ARE OF CONCERN TO WATER PROVIDERS? All sensitive subpopulations should be of concern to water suppliers:  None of the groups discussed above live only in urban or rural areas. While there may be differences between the relative proportions of these subgroups between rural and urban areas, they are only of degree. Broadly, the trends noted earlier (an aging population, more chronic diseases, more immunosuppression in the population) are occurring throughout the population in the United States and in other countries.  Legally, the USEPA must examine the effects of regulations on sensitive subpopulations (implying that they cannot be dismissed from consideration).  It should be ethically supposed that people who live in rural or urban areas, or people who are served by large or small systems, are equally deserving of good-quality water.  All people move back and forth between states of sensitivity, moving from a sensitive (infancy, pregnancy, old age) to a nonsensitive subpopulation (healthy adult) throughout their lives.  Water contaminants are generally of concern to multiple subgroups, and not one group only, so that ignoring one particular group is unlikely to actually reduce the need to be concerned about the contaminant. For example, Cryptosporidium is mostly linked to deaths in people with AIDS, yet it kills infants via dehydrating diarrhea, and causes significant disease and results in loss of work in other groups. A chemical contaminant that has been linked to cancer could affect children, pregnant women, and people who have already had a cancer to a disproportionate extent.  Water systems in all regions of the United States serve people with infants, children, pregnant women, the elderly (both frail and well), people with AIDS, people with cancers, people who undergo chemotherapy, people with diabetes, and people with rheumatoid arthritis, asthma, inflammatory bowel disease, and other autoimmune disease that may require immunosuppressive treatment. Two arguments can be made against considering some sensitive subpopulations under specific circumstances. The first is in the case of transient noncommunity systems, where the period of exposure to anything in the water is presumed to be short. In this case, acute exposure risks that sensitive subpopulations experience are of greater public health concern than are chronic exposure risks (this is discussed in more detail below). The second argument, very small systems, where the likelihood of a system providing water to a person with an unusual or rare sensitivity would be quite low. The difficulty with this second argument is addressed in this next section.

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20.7 CAN OR SHOULD A WATER SUPPLIER IDENTIFY WHO BELONGS TO A SENSITIVE SUBPOPULATION? Mechanisms already exist in many water systems for people with specific needs to receive special delivery of water when there is a failure in the supply, as in pregnant women and infants when there are nitrates in the water exceeding the standards, and for people who are on dialysis. Many communities have arrangements to contact local medical care providers or others when drinking water is not safe, so that these medical care providers can contact specific sensitive individuals. These mechanisms are not fail-safe, but are very useful. One proposed answer to the issues raised by serving sensitive subpopulations has been the concept of delivering two quality grades of water. One grade would be the standard quality, and the other (perhaps delivered as bottled water) would be for sensitive subpopulations. A primary difficulty in addressing the needs of sensitive populations lies in people’s rights to privacy and confidentiality. Many people face discrimination because of being HIV-seropositive or having AIDS, and they are very unlikely to identify themselves to anyone who is not sworn to secrecy. Furthermore, many people with HIV do not know they have this infection until their disease is quite advanced. Others might not want to disclose to a public authority or water supplier the fact that they have cancer, diabetes, or some other condition that makes them part of a sensitive subpopulation. Pregnancy may be something that is hidden if it is not a condoned pregnancy. A pregnant adolescent might be very reluctant to have this information made public. In contrast, it is hard to imagine that a family would not tell a supplier that they had a baby, so that the supplier could provide lownitrate water if need be. Finally, delivery of water to an address might be the equivalent of a public announcement of sensitivity, so some might balk at this remedy. A water supplier could do an anonymous survey of their community to ask if anyone has a condition that might render them susceptible, but few people reply to these surveys, and would have no obligation to do so. In addition, for small systems, it might still be possible to guess who someone is, and such surveys would be confidential only in name but not in practice. Investing effort in trying to address concerns about sensitive populations by identification of the sensitive so that they can receive some secondary water supply is, in the opinion of this author, unproductive. The potential for lawsuits and for unintentional harm to people seems very large; lists of the sensitive would have to be constantly updated and protected from prying eyes, and from a public relations viewpoint, could be interpreted very negatively.

20.8

NONTRANSIENT AND TRANSIENT NONCOMMUNITY SYSTEMS

Nontransient noncommunity systems serve important segments of the population at various locations, such as schools, and occasionally hospitals. Obviously, water systems that serve schools are serving children and women of childbearing age.

20.9 RELEVANT PUBLIC HEALTH CONCEPTS

507

Systems that serve hospitals are serving very ill people, many of whom have other illnesses or depressed immune systems. Concerns about sensitive subpopulations would be expected under these circumstances. Significant long-term drinking water ingestion occurs at other nontransient noncommunity sites, such as offices and factories, and thus the same concerns probably still hold. Transient noncommunity systems are defined as noncommunity systems that do not supply the same population. The CDC has issued a report on waterborne disease outbreaks in 1997=98. Most of the outbreaks were associated with groundwater supplies, many were noncommunity, and all the reported parasitic infections were Cryptosporidium (Barwick et al. 2000). See Chapter 3 for a discussion of waterborne disease outbreaks in noncommunity systems. Thus it is likely that there will be an impetus to include these water systems in regulations that consider sensitive subpopulations. Balancing this impetus will be the fact that exposures to these water supplies are generally brief and not sustained. These circumstances suggest that the major public health concern regarding transient noncommunity systems will be to prevent acute exposures that could lead to harm, acknowledging that the harm that could be due to chronic exposures is unlikely, since these are (by definition) transient systems. Exposures to infectious organisms, and to elevated trihalomethane levels (given the concerns around reproductive risks), would be examples of the acute exposures one would work to avoid. In contrast, transient exposures to agents that require chronic exposure to do harm might not bear the same public health implications.

20.9 PUBLIC HEALTH CONCEPTS RELEVANT TO SENSITIVE SUBPOPULATIONS Protecting sensitive subpopulations will be challenging for the water supplier. As more is being learned about what constitutes a sensitive population and what factors are of concern, strategies to address the needs of these populations will need to be developed and frequently reviewed and revised. The following public health concepts are relevant to sensitive subpopulations and should be considered in the development of intervention strategies. 20.9.1

Reducing or Eliminating Exposure

The whole discipline of public health arose from the recognition that society could benefit by the identification of specific hazards and then removing or reducing them. Public health protection operates by identifying and then removing risks. For adverse health events to occur, the sensitive individuals or population must be exposed to the thing or risks that are hazardous for them. Thus, the clear intent of source water protection, drinking water treatment, and the like is to reduce or eliminate the chance that these people, as well as the general population, will be exposed to these hazards. Examples include the identification of diarrheal diseases with contaminated drinking water in the 1800s, lung cancer and smoking after World War II, and

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tuberculosis with raw milk. Each led to specific measures to reduce exposures of concern, such as water treatment with chlorination and filtration, smoking cessation, and pasteurization of milk, respectively. 20.9.2

Acting on Suspicion

When considering hazards and sensitive subpopulations, it is important to understand some of the reasoning behind public health protections. Because the health and well-being of humans is at stake, public health action is often taken when there is only a suspicion that injury could arise. Preventive actions or steps are taken not only when it is certain that some harm could occur, but also when there is a reasonable chance that the harm could occur. Prudent avoidance is justified as being better than resolving problems after they occur (‘‘an ounce of prevention is better than a pound of cure’’). An example of this is that pregnant women are not given medications that have not been shown to be safe for them to take, because of the presumption that some medications will cause harm to the fetus, such as birth defects or even miscarriage. Similarly, boil water advisories are often be issued because water quality indicators have deteriorated, rather than because some group of people has already become ill. This inevitably leads to conflict with those who believe that preventive actions should be taken only when the risk has been proved to exist. 20.9.3

Defining Increased Risk

As a result of a comparison between the likelihood of the event between the group of interest (e.g., young children) and the comparison group (the whole population), it is found that the likelihood is greater in the group of interest. How does one talk of increased risk? By stating either an absolute or a comparative rate. An absolute rate is something like ‘‘10 cases of pneumonia per 100,000 people,’’ whereas a comparative rate is something like ‘‘twice as likely to occur in children than in adults.’’ Both are valid ways to discuss a risk. 20.9.4

How Significant Is Increased Risk?

Significance is measured in several ways. First is the overall risk. In common terms, being killed by lightning is less common than being killed in an automobile accident, so deaths from automobile accidents are ‘‘more important’’ or ‘‘more significant’’ than deaths from lightning to society. A second way to measure significance has to do with the statistical meaning, which has to do with the confidence that the increased (or decreased) risk is actually present. (From a regulatory point of view, U.S. law now states that ‘‘susceptible’’ or ‘‘sensitive’’ populations must have their risks explicitly considered, making their risks of significance to water suppliers.) 20.9.5

Defining an Adverse Event or Outcome

An ‘‘adverse event or outcome’’ is something that is deleterious to the person, like pain, discomfort, illness, lost work, decreased function, decreased lifespan, or death (this list is obviously long). Some adverse events are self-limited, and others are

20.10 FUTURE OUTLOOK

509

permanent, making them more severe or adverse. It is sometimes nearly impossible to quantify exactly how severe an adverse outcome is (e.g., what is the value of a life, or a lost limb, or 5 years of lifespan), but is it usually possible to rank or order adverse outcomes (death is worse than a chronic disease, which is worse than a disease that is temporary). A variety of scales to rank adverse outcomes are available, and each has its advantages or disadvantages. 20.10

FUTURE OUTLOOK

All of us begin life as infants, and hopefully end life having lived to an advanced age. Both of these life-cycle stages are composed of sensitive individuals. Pregnant women, another sensitive subpopulation, are key to the survival of our species. Some people are in a sensitive subpopulation for genetic reasons, and others acquire medical conditions (such as diabetes or AIDS) that put them at special risk. Many people do not know that they are at increased risk of adverse health outcomes from drinking water contaminants. Furthermore, individuals in some sensitive subpopulations are reluctant to identify themselves as different from the general population. Thus, practically speaking, public drinking water will be made available to some people who are in sensitive subpopulation groups. As time progresses, a growing number of individuals will belong to one or more sensitive subpopulations. As a population we are living longer. This is, of course, to be welcomed, although it means that the percentage of the population that is elderly is growing rapidly. More and more individuals in the United States have chronic medical conditions such as asthma and diabetes. Some people with asthma must take drugs (steroids) that weaken their immune systems, and diabetics are well known to be prone to infections. Medical advances have made even AIDS a chronic condition for some, and these individuals are again especially sensitive to infections. Others, lucky enough to receive a transplantation, must take potent immunosuppressive drugs for the rest of their lives, making them more likely to have malignancies and infections. Thus we as a population are changing, and many more of us find ourselves in sensitive subpopulation groups. Pregnant women, infants, and the elderly, as well as people with immunosuppressive conditions, are distributed throughout the U.S. population. Thus it must be concluded that the need to consider sensitive subpopulations is one for all water suppliers. It is inevitable that as science progresses, more groups of people with specific sensitivities will be identified. Between the population shifts that suggest increasing populationwide sensitivity, and an enlarging list of groups that will be identified as being sensitive, the issues regarding drinking-water-sensitive subpopulations are likely to increase in importance and not decrease over time. ACKNOWLEDGMENTS This chapter was adapted from a White Paper prepared by the author for the National Rural Water Association, and on material presented at the SDWA Futures Forum sponsored by the USEPA in December 1999.

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REFERENCES Balbus, J. R., R. Parkin, and M. Embrey. 2000. Susceptibility in microbial risk assessment: Definitions and research needs. Environ. Health Perspect. 108(9):901–905. Barwick, R. S., D. A. Levy, G. F. Craun, M. J. Beach, and R. L. Calderon. 2000. Surveillance for Waterborne-Disease Oubreaks—United States, 1997–1998. Morbid. Mortal. Weekly Report 49(SS04):1–35 (May 26, 2000). Ben-Yehund, A. and M. E. Weksler, 1992. Host resistance and the immune system. Clin. Geriatr. Med. 8:701–711. CDC. 1998. National Diabetes Fact Sheet: National Estimates and General Information on Diabetes in the United States, rev. ed. Atlanta, GA: U.S. Dept. Health and Human Services, Centers for Disease Control and Prevention. CDC. 2000a. HIV=AIDS Surveillance Report 12(1). Atlanta, GA: U.S. Dept. Health and Human Services, Centers for Disease Control and Prevention. CDC. 2000b. HIV=AIDS Surveillance Supplemental Report 7(1). Atlanta, GA: U.S. Dept. Health and Human Services, Centers for Disease Control and Prevention. CDC. 2000c. National Center for HIV, STD, and TB Prevention, Division of HIV=AIDS Prevention. AIDS Surveillance—Trends. L207 Slide Series (through 1999). U.S. Dept. Health and Human Services, Centers for Disease Control and Prevention, url: http:==www.cdc.gov=hiv=graphics=trends.htm. CDC. 2000d. National Center for HIV, STD, and TB Prevention, Division of HIV=AIDS Prevention. AIDS Surveillance—General Epidemiology. L178 Slide Series (through 1999). U.S. Dept. Health and Human Services, Centers for Disease Control and Prevention, url: http:==www.cdc.gov=hiv=graphics=surveill.htm. CDC. 2000e. National Center for HIV, STD, and TB Prevention, Division of HIV=AIDS Prevention. AIDS Surveillance—in Urban=Nonurban Areas. L206 Slide Series (through 1999). U.S. Dept. Health and Human Services, Centers for Disease Control and Prevention, url: http:==www.cdc.gov=hiv=graphics=rural-urban.htm. Garibaldi, R. A., S. Brodine, and S. Matsumiya. 1981. Infections among patients in nursing homes. Policies, prevalence, and problems. New Engl. J. Med. 305:731–735. Howe, H. L., P. A. Wingo, M. J. Thun, L. A. G. Ries, H. M. Rosenberg, E. G. Feigal, and B. K. Edwards. 2001. The Annual Report to the Nation on the Status of Cancer (1973 through 1998), Featuring Cancers with Recent Increasing Trends. J. Natl. Cancer Inst. 93(11):824–842. Mahaffey, K. R. 2000. Recent advances in recognition of low-level methylmercury poisoning. Current Opin. Neurol. 13:699–707. National Cancer Institute. 1999. Atlas of Cancer Mortality in the United States, 1950–1994. Washington DC. NRC. 2001. Classifying Drinking Water Contaminants for Regulatory Consideration. Washington DC. National Academy Press. Okun, D. A. 1999. Historical overview of drinking water contaminants and public water utilities. In Identifying Drinking Water Contaminants. Washington DC: National Academy Press, pp. 22–32. Parkins, R. T., and J. M. Balbus. 2000. Variations in concepts of susceptibility in risk assessment. Risk Analysis 20(5):603–611.

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Ries, L. A. G., P. A. Wingo, D. S. Miller, H. L. Howe, H. K. Weir, H. M. Rosenberg, S. W. Verson, K. Cronin, and B. K. Edwards. 2000. The Annual Report to the Nation on the Status of Cancer, 1973–1997, with a Special Section on Colorectal Cancer. Cancer 88(10):2398–2424. Ruben, F. L., S. R. Dearwater, C. W. Norden, L. H. Kuller, K. Gartner, A. Shalley, G. Warshafsky, et al. 1995. Clinical infections in the noninstitutionalized geriatric age group: Methods utilized and incidence of infections. The Pittsburgh Good Health Study. Am. J. Epidemiol. 141(2):141–157. Ryan, M. J., P. G. Wall, G. K. Adak, H. S. Evan, and J. M. Cowden. 1997. Outbreaks of infectious intestinal disease in residential institutions in England and Wales 1992–1994. J. Infect. 34(1):49–54. Swan, S. H., K. Waller, B. Hopkins, G. Windham, L. Fenster, C. Schaefer, and R. Neutra. 1998. A prospective study of spontaneous abortion: Relation to amount and source of drinking water consumed in early pregnancy. Epidemiology 9(2):126–133. U.S. Census Bureau. 2001. International Data Base (www.census.gov=ipc=www=idbnew.html), Washington, DC. USEPA. 1998. National Primary Drinking Water Regulations: Disinfectants and Disinfection Byproducts Notice of Data Availability. EPA 40 CFR Parts 141 and 142 (WH-FRL-5988-7) (Fed. Reg. 63:15673–15692). USEPA. 1999. Children and Drinking Water Standards. EPA 815-K-99-001, www.epa.gov= children. Washington, DC: Office of Ground Water and Drinking Water. USEPA. 2000. Report to Congress. EPA Studies on Sensitive Subpopulations and Drinking Water Contaminants. EPA 815-R-00-015. Washington, DC: Office of Water. Waller, K., S. H. Swan, G. DeLorenze, and B. Hopkins. 1998. Trihalomethanes in drinking water and spontaneous abortion. Epidemiology 9(2):134–140.

21 ENVIRONMENTAL JUSTICE AND DRINKING WATER REGULATION FREDERICK W. PONTIUS, P.E. Pontius Water Consultants, Inc., Lakewood, Colorado

21.1

INTRODUCTION

Environmental justice (EJ) is a relatively new concern for drinking water suppliers. It has emerged as a consideration in regulatory policy only since the early 1990’s (Cole and Foster 2000). EJ is a blend of concern for environmental protection and for impoverished minority communities. Most efforts concerning EJ have focused on pollution from industrial sites (Cooper 1998). The U.S. Environmental Protection Agency (USEPA) first addressed EJ issues in regulating drinking water in developing its proposed rule for radon. This chapter introduces EJ and EJ issues that may become important considerations for water suppliers.

21.2

ENVIRONMENTAL JUSTICE AS A MOVEMENT

The early history and progression of the EJ movement has been the subject of several reviews (Cole and Foster 2000, Cooper 1998, Foreman 1998). The historical progression of EJ is summarized in Table 21.1. Foreman (1998) has provided a comprehensive analysis and critique of the EJ movement, considering aspects of politics, science, and policy. Throughout the 1960s and 1970s the environmental agenda in the United States was essentially separate from issues associated with Drinking Water Regulation and Health, Edited by Frederick W. Pontius. ISBN 0-471-41554-5 # 2003 John Wiley & Sons, Inc.

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TABLE 21.1

Environmental Justice Historical Progression

Year

Event

1971

CEQ annual report finds environmental inequity by income Inequitable distribution of air pollution by race and income was found in three urban areas Residents of Warren County, NC, protest proposed PCB disposal landfill Inequitable distribution of solid-waste facilities by race was found in Houston UCC released a nationwide study finding inequitable distribution of hazardous-waste facilities by race and income Los Angeles residents successfully block construction of a garbage incinerator in a black community Conference on Race and the Incidence of Environmental Hazards held in Ann Arbor, MI First National People of Color Environmental Leadership Summit convened in Washington, DC J. U.S. Environ. Protect. Agency published ‘‘Environmental protection—has it been fair?’’ Environmental Justice Act of 1992 introduced into the U.S. Senate; reintroduced in 1993 USEPA publishes Environmental Equity: Reducing Risks for All Communities; Office of Environmental Equity established National Environmental Justice Advisory Council created Environmental justice becomes one of USEPA’s top priorities Executive Order 12898 issued: ‘‘Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations’’ Study of commercial hazardous-waste facilities conclusions contradict UCC study, causing debate on methodology of environmental justice studies Federal agencies issue environmental justice strategies Permit for Louisiana Energy Services denied on environmental justice (EJ) grounds by the Nuclear Regulatory Commission for a license to and operate an uranium enrichment plant in mostly poor and African-American Louisiana communities Supreme Court heard the case of Seif et al. vs. Chester Residents concerned for Quality Living, deciding whether a private group could sue a state or local government for allegedly discriminatory effects of its policies; the case was dismissed as moot

1972 1982 1983 1987 1987 1990 1991 1992 1992 1992 1993 1993 1994 1994

1995 1997

1998

Reference CEQ (1971) Freeman (1972) UCC (1987) Bullard (1984) UCC (1987) Lee (1992) Mohai and Bryant (1992) Lee (1992) Heritage (1992) Sexton et al. (1993) USEPA (1992)

EO (1994) Anderton et al. (1994)

USNRC (1997)

21.2 ENVIRONMENTAL JUSTICE AS A MOVEMENT

TABLE 21.1 1998 1999 2001

2001 2002

515

(Continued )

USEPA holds videoteleconference with stakeholders to discuss EJ issues and drinking water regulation USEPA issues a proposed rule for radon in drinking water, the first drinking water rule to consider EJ issues USEPA Administrator Whitman reaffirms the agency’s commitment to EJ in memorandum to agency staff. Environmental Law Institute issues analysis of USEPA EJ statutory authorities USGAO issues study of community investment

USEPA (1999a)

USEPA (2001c)

ELI (2001) USGAO (2002)

racial minorities and low-income populations. The EJ movement began in the early 1980s, started primarily by people of color needing to address inequities of environmental protection pollution in their communities (Cooper 1998). Environmental decisions of government and business are acknowledged now as potentially having serious equity implications, especially for minority and low-income communities. Three terms have historically been used to communicate the concerns embodied in the EJ movement: environmental equity, environmental racism, and environmental justice. In July 1990, USEPA formed an Environmental Equity Workgroup to review and evaluate the evidence that racial minority and low-income people bear a disproportionate risk burden. The agency then defined ‘‘environmental equity’’ as ‘‘the distribution of environmental risks across population groups and to our policy responses to these distributions’’ (USEPA 1992). ‘‘Environmental racism’’ asserts that racism, whether intentional or unintentional, underlies variation in the distribution of environmental pollution. Environmentalism and civil rights are fused together. But disparate pollution impacts across population groups may or may not be motivated by overt discrimination in any particular environmental action. ‘‘Environmental justice’’ is a comprehensive term, embracing the ideal of environmental protection and fairness for disadvantaged persons. USEPA (2001a) defines EJ as the fair treatment and meaningful involvement of all people regardless of race, color, national origin, or income with respect to the development, implementation, and enforcement of environmental laws, regulations, and policies. Fair treatment means that no group of people, including a racial, ethnic, or socioeconomic group, should bear a disproportionate share of the negative environmental consequences resulting from industrial, municipal, and commercial operations or the execution of federal, state, local, and tribal programs and policies.

In 1992, USEPA created the Office of Environmental Justice in response to public concern and at the recommendation of the Environmental Equity Workgroup. This

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Office oversees the integration of environmental justice into USEPA’s policies, programs, and activities throughout the Agency, serves as the point of contact for environmental justice outreach and educational activities, and provides technical and financial assistance. It also serves as the lead on an Interagency Working Group of other federal agencies to incorporate environmental justice into all federal programs. An expansive view of relevant EJ-related statutory provisions contained in principal federal environmental laws administered by USEPA has been recently completed by the Environmental Law Institute (ELI 2001). USEPA’s legal authority to consider and address EJ issues is grounded in specific statutes, administrative laws, cross-cutting federal statutes, and executive orders and policies. 21.2.1

National Environmental Justice Advisory Council

To obtain stakeholder advice on implementation of an national environmental justice program, USEPA chartered the National Environmental Justice Advisory Council (NEJAC) in 1993 under the Federal Advisory Committee Act (FACA). This Council provides independent advice to USEPA on matters relating to environmental justice. It consists of 25 members appointed from stakeholder groups including community-based organizations, business and industry, academic and educational institutions, state and local government agencies, tribal government and community groups, nongovernmental organizations, and environmental groups. NEJAC provides consensus advice on a variety of documents, including USEPA’s EJ agenda, strategic plan, and annual report. The Council meets 2–3 times a year throughout the country to receive comments from local citizens and community groups on the state of the environment in local areas. NEJAC has six subcommittees organized around themes to help develop strategic options for USEPA: (1) Waste and Facility Siting, (2) Enforcement, (3) Health and Research, (4) Air and Water, (5) Indigenous Peoples, and (6) International. 21.2.2

Executive Order 12898

Executive Order (EO) 12898, Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations, was issued on Feb. 11, 1994 (EO 1994). This Order focused federal attention on the environmental and human health conditions of minority and low-income populations with the goal of achieving environmental protection for all communities. The Order extends the reach of Title VI of the Civil Rights Act to unintentional discrimination. Although Title VI itself prohibits only intentional discrimination, federal agency regulations to implement Title VI prohibit programs and activities that have the ‘‘effect’’ of racial discrimination. EO 12898 directed federal agencies to develop environmental justice strategies to identify and address disproportionately severe and adverse human health or environmental effects of their programs, policies, and activities on minority and low-income populations. The Order was intended to promote nondiscrimination in federal programs substantially affecting human health and the environment, and to

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provide minority and low-income communities access to public information, and an opportunity for public participation in matters relating to human health or the environment. Federal agencies may terminate funds for programs and activities that impose disparate impacts on different racial groups. Citizens and public interest groups have filed administrative and judicial complaints that allege specific projects have disparate impacts on minority and=or low-income populations, in violation of federal agency Title VI regulations, other federal=civil rights and regulatory statutes, and EO 12898. In the eyes of EJ advocates, any disproportionate distribution of environmental risks is evidence in and of itself of environmental racism. Proof of racial intent is not needed. However, under the Equal Protection Clause of the U.S. Constitution, proof of intention to discriminate, which is often very difficult, is necessary. EJ challenges may also address  Whether federal, state, or local government agencies have provided meaningful and equal access and consideration to minority and low-income individuals  Whether government agencies have fairly and equally enforced environmental requirements in minority and low-income communities EJ challenges by citizens and public interest groups may be a precursor to or combined with toxic tort suits. The increasing availability of information regarding industrial pollutants and drinking water quality continuously fuels EJ concerns.

21.3

IDENTIFYING ENVIRONMENTAL JUSTICE SITUATIONS

In general, minorities and poor families are thought to disproportionately live in communities with landfills, hazardous-waste facilities, incinerators, industrial plants, and old housing with poor indoor air quality and lead-based paint. In addition, residents of these communities are more likely than those of more affluent communities to consume fish on a regular basis from local waters, many of which have been banned. Children in these communities may be exposed more frequently than are children in other communities to potentially dangerous contaminants that can affect health. Data indicate that poor and minority children have higher rates of asthma, elevated blood lead levels, learning disabilities, and hyperactivity than do nonminority and more affluent children (Powell and Stewart 2001).

21.3.1

Environmental Justice Communities

Identifying and addressing specific EJ situations can be difficult and is sometimes very contentious. USEPA considers EJ communities to be those where the residents (1) are a minority and=or low income group, (2) are excluded from the environmental policy setting and=or decisionmaking process, (3) are subject to a dispropor-

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tionate impact from one or more environmental hazards, and (4) experience a disparate implementation of environmental regulations, requirements, practices and activities in their communities (USEPA 2001b). The difficulty of evaluating potential EJ communities is illustrated in a recent U.S. General Accounting Office (USGAO 2002) study. USGAO contacted 15 facilities— 9 non-hazardous-waste-related facilities, 3 hazardous-waste disposal facilities, 2 chemical plants, and 1 concrete plant—in 9 locations and requested information on jobs as well as on other contributions made to the surrounding communities. In each case selected for review, communities had filed complaints about the facilities. USGAO also contacted government officials in each of these locations to determine the changes in property values and to identify any incentives used by the facilities. In addition, representatives from community and environmental action groups were interviewed. USGAO reported that the number of full-time jobs at the time of the review ranged from 4 to 103 per facility, with 9 of the facilities having 25 jobs or less. According to facility officials, these jobs included unskilled, trade, technical, administrative, and professional positions that had salaries ranging from about $15,000 to $80,000 per year, depending on factors such as the type of work and the location of the facility. It is not known how many people were hired at each salary level or how many of those hired lived in the communities near the facilities. Most of the facilities identified other contributions that they had made or planned to make to the communities in which they were located. These contributions included volunteer work such as organizing cleanups, infrastructure improvements such as installing a new water drainage system, and financial assistance to schools, universities, community groups, and other organizations. In three cases, the facilities established a foundation or a fund to manage and disburse the financial contributions. In one case, a facility set up a foundation after community groups took legal action. In another case, the foundation was not linked to legal action. The fund resulted from collaboration among the community, the state environmental agency, and the facility and ultimately resulted in the community dropping the complaint it had filed with USEPA. Reported contributions by the facilities to the different communities were not verified, and the value of incentives not estimated. Regarding this study, USGAO (2002) noted Despite these efforts, community residents often felt the facilities’ contributions did not adequately address their concerns. Property values in a community are affected by many factors, including the condition of the land and houses, the proximity of the property to natural or manmade structures—such as the facilities covered by this study—that might be viewed as desirable or undesirable, and economic conditions in the surrounding or adjacent communities. Information on property values was not available for most of the communities where the facilities were located. However, some information was available for two locations: Genesee County, Michigan, and South Bronx, New York. Even in these two locations, the information available was not specific enough to isolate the effect of the facility on property values because of other factors that can affect property values. In locations where property value data were not available, community groups voiced concerns that the facilities would cause

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property values to decline. Officials at 6 of the 15 facilities we studied said they had used incentives or subsidies that were available in a particular area. The officials said the facilities were located in these areas because of low land costs, favorable zoning, or other factors. The incentives varied, depending on the type of facility and its location, but included tax exemptions, a local bond initiative, reductions in regulatory fees, and reduced utility rates.

Sharp disagreements can occur regarding the extent of injustice in a particular area, (Mastio 1998a) whether health risks associated with low levels of certain environmental pollutants pose a significant risk, how economic justice issues (disparate impacts on employment opportunities in low income areas) should be considered (Pepper 1998, Johnson 1998, Mastio 1998b), and the benefits of community investments made by the facility of concern. Both minority and nonminority communities often have similar suspicions of experts and health officials who minimize hazards that residents believe to be significant. Defining priorities in the face of diverse and competing minority, environmental, and economic interests is difficult, if not impossible, in some situations (Overholser 1999, Clegg 1998). EJ advocates may perceive scientists’ insistence on defining cause–effect relationships as an excuse for delaying governmental action to address their particular problem. Frustration can result when scientists cannot provide definitive answers to EJ questions.

21.3.2

Key Factors

Factors generally considered in environmental justice analysis are summarized in Table 21.2 (USEPA 1998). There is no one uniform measure applicable to all studies or situations. Each EJ study to be undertaken must identify and measure the factors appropriate for the study area and population(s). Examples of population measures that might be used in EJ studies are listed in Table 21.3 (Liu 2001). Perhaps the most important factor associated with EJ studies is that of sensitivity to pollutants. Liu (2001) presents examples of highly susceptible or exposed subpopulations, summarized in Table 21.4. Protecting sensitive subpopulations is discussed further in Chapter 20.

21.3.3

Economic Tradeoffs

Economic tradeoffs also impact low-income communities. Overall, more than onethird of households with incomes under $10,000 are unable to meet at least one basic need (Bauman 1998). Bauman (1999) notes: In 1995 . . . about 1 person in 5 lived in a household that had at least one difficulty meeting basic needs. These included households that didn’t pay utility bills, didn’t pay mortgage or rent, needed to see the doctor or dentist but didn’t go, had telephone or utility service shut off, were evicted, didn’t get enough to eat, or otherwise didn’t meet essential expenses.

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TABLE 21.2 Factors to Consider in Environmental Justice Analysis Category Potential exposure and risk

Factors

Variables

Demographic

Race, ethnicity, income, age, gender, disability Susceptible and highly exposed populations Population density Population literacy Population=economic growth Climate Land use=land cover Topographic and geomorphic features Hydrologic features Individual economic conditions Income level=healthcare access Infrastructure conditions such as water and sewage Life-support resources such as subsistence living Distribution of costs to pay for environmental projects by user fees for necessary goods and services Community economic base Industrial Brownfields Natural resources Proximity to environmentally risky facilities Public perception of risks Toxics, pollutants, and pesticides Emission sources, amount, and distribution Exposures: locations, multiple, cumulative, synergistic Health status and effects Research gaps (e.g., subsistence consumption, dietary effects) Data collection=analysis reliability and validity Public access to the decisionmaking process Cultural expectations and understanding of the decisionmaking process Meaningful information about risk assessment and management Job security Literacy rate for consideration in choosing the right communication materials Translations for non-English-speaking audience Community representation

Geographic

Economic

Human health and risk

Cultural and ethnic differences and communications concerns

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TABLE 21.2 (Continued ) Category

Factors

Historical and policy issues

Variables Community identification Indigenous populations Industrial concentration Inconsistent standards in enforcement and site selection Research gaps Program gaps Noninclusive processes Past practices Cultural diversity Obligations

Source: USEPA (1998).

Should industries close down and=or locate in other areas, employment opportunities diminish. With regard to drinking water, increased water rates because of new regulations or other factors impose additional economic pressure on EJ communities. Any increased public health benefit in an EJ community from new water regulations may be negated by the tradeoffs that low-income households will make in order to pay for higher water rates. Rubin (1999) notes: a potentially significant consequence of a new regulation is that low-income households will make tradeoffs in order to pay their water bill. The literature is replete with studies that show that low-income households already are forced to make serious tradeoffs that affect the health and well-being of their members, including foregoing food and medical care [see also Edin and Lein (1997), USDA (1997)]. By diverting needed funds from other necessities, a new drinking water regulation could adversely affect public health.

On the other hand, an adequate supply of safe drinking water is an important benefit to a low-income and=or minority community. Safe drinking water may serve as a selling point to attract future industry and business development, thereby providing more employment opportunities. Although water systems may act on their own initiative to address unregulated drinking water contaminants, in some situations, issuance of drinking water regulations is a necessary prerequisite to action. Drinking water affordability has been discussed in detail elsewhere (Beecher and Shanaghan 1998, Rubin 1998)—the relevant point here is that, as drinking water rates increase for whatever reason, consumer choices will be made that could negate assumed benefits, especially in low-income groups characteristic of EJ communities. 21.3.4

Intergenerational Equity

Syme et al. (2000) note that intergenerational justice must be considered if ecological, economic, and social components of sustainability are to be achieved. Inter-

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TABLE 21.3

Examples of Population Measures Used in Environmental Justice Studies

Population Variables Race=ethnicity measures

Income

Age

Housing

Education

Minority

% poor

Measures % black or African American, % Native American, % Asian=Pacific Islander, % other races, % Hispanic, % nonwhite, % minorities % families below poverty level, % population below poverty level, per capita income, median family income, mean family income, family income distribution, median household income, mean household income, household income distribution, % households receiving public assistance, median black household income, % poor, % poor whites, % poor blacks among all the poor, % poor blacks among blacks % population <5 years old (% young) % population <15 years old % population <18 years old % population 65 years (% elderly) % female age 15–44 Median age Median value of owner-occupied housing units (housing stock) Median rent Mean estimated house value Median % of income devoted to rent Mean age of housing units % housing units built before 1940 Housing tenure (owner occupied or rent) % housing units occupied by owners % housing units vacant % population with 12 years of schooling % adults with 4 years of college Average years of school by persons age 25 Often defined as the segment of the population composed of black population not of Hispanic origin, Native American not of Hispanic origin, Asian and Pacific Islander not of Hispanic origin, other races not of Hispanic origin, population of Hispanic origin The number of persons living below the poverty level ($12,674 for a family of 4 in 1990) divided by the number of persons in the adjusted total population (i.e., total population less those held in institutions such as prisons and psychiatric hospitals)

Source: Liu (2001).

generational issues cannot be considered in isolation from other current risk and fairness concerns. What is this generation’s obligation to future generations? In 1994, this question was posed to the National Academy of Public Administration (NAPA) by the U.S. Department of Energy within the context of disposal of radioactive waste. In

21.3 IDENTIFYING ENVIRONMENTAL JUSTICE SITUATIONS

TABLE 21.4

523

Examples of Highly Susceptible or Exposed Subpopulations

Subpopulation

Susceptible Factors

Subpopulation

Exposure Factors

Asthmatics

Increased airway responsiveness to allergens, respiratory irritants, and infectious agents

Industrial workers

Fetuses

Sensitivity of developing organs to toxicants that cause birth defects Sensitivity of developing brain to neurotoxic agents such as lead Diminished detoxification and elimination mechanisms in kidney and liver Nutritional deficiencies and poor access to healthcare Inherited deficiency of a protein that protects against chemical damage Diminished detoxification of some carcinogens and medicines

Farmers

Higher exposure to job-related hazardous chemicals through breathing and skin contact; more lung exposure due to physically demanding work Pesticide exposure

Subsistence and sports fishers

Higher fish consumption

Infants and children

Higher consumption of fruit, vegetables, and fruit juices; higher inhalation rates Higher exposure to lead, air pollution, and toxics

Infants and young children

Elderly

Low-income population

a1-Antitrypsindeficient persons

Glutathione-Stransferase deficient persons

Low-income and minority population

Source: Liu (2001).

response, NAPA issued a seminal report intergenerational equity. The NAPA (1997) panel’s intergenerational obligation requires that ‘‘No generation should (needlessly), now or in the future, deprive its successors of the opportunity to enjoy a quality of life equivalent to its own.’’ This objective is supported by four fundamental principles that must be taken together to address decisions for multiple generations: 1. Trusteeship. Every generation has obligations as a trustee to protect the interests to future generations.

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2. Sustainability. No generation should deprive future generations of the opportunity for a quality of life comparable to its own. The reduction of resource stocks entails a duty to develop substitutes. 3. Chain of Obligation. The primary obligation is to provide for the needs of the living and succeeding generations. Near-term concrete hazards have priority over long-term hypothetical hazards. In other words, there is an obligation to protect future generations provided the interests of the present generation and its immediate offspring are not jeopardized. This principle provides important guidance on the practical reality of how to allocate resources in a world in which the resources, both financial and natural, are finite. The priority is to protect the present generation and its immediate offspring because if they are not protected, there will be no future generations. 4. Precautionary. Do not pursue actions that pose a realistic threat of irreversible harm or catastrophic consequences unless there is some compelling or countervailing need to benefit either current or future generations. The NAPA panel introduced the concept of a ‘‘rolling future’’ that acknowledges the reality of uncertainty in generational decisionmaking. Such an approach accommodates changes in values, society, and technology that occurs over generations. A decision should not be expected to be final for all generations or that it will solve all presently perceived problems for future generations. In addition, decisionmaking processes (Kadak 2000)  Must be inclusive, open, and transparent and should seek out public input.  Must be honest, realistic, credible, flexible, and capable of change in response to new information.  Must acknowledge and directly deal with, instead of avoid, different value systems. In the decision, the values on which the decision is made must be explicitly stated because, in the future, the values may be different, leading to different actions.  Must be linked to current institutions. It cannot be assumed that a better institutional system will exist in the future to solve the problem, nor should it be assumed that current institutions will, by definition, disappear.  Should consider risks and benefits to each generation.  Should be able to identify and discriminate between tolerable and intolerable consequences.  Should acknowledge that there are means of prevention and mitigation in the event that the present decision may not be correct for intergenerational time.  Should not ignore the role of technological advancement. Nor should society rely on technology to solve all problems.  Should recognize the limitation in funds and resources to tackle long-term problems. Otherwise the process will not be honest, result in wasted resources and public distrust.

21.3 IDENTIFYING ENVIRONMENTAL JUSTICE SITUATIONS

21.3.5

525

Quantitative Methods

Progress has been made to develop quantitative methods for analyzing specific EJ situations. Liu (2001) presents the most comprehensive discussion of EJ analysis, theories, methods, and practice, especially in transportation planning, industrial siting, and other areas related to development. But no attention has been given to quantitative methods and approaches addressing drinking water as an EJ issue. Mills and Neuhauser (2000) analyzed EJ issues associated with transportation of hazardous materials. Methods of comparing populations and their racial=ethnic compositions using simple tabulations, histograms, and chi-square (w2) tests for statistical significance of differences are discussed. Two examples are presented: comparison of two routes and comparison of a route with its surroundings. Carlin and Xia (1999) have presented a statistical methodology for assessing EJ using Bayesian hierarchical models. Two examples were evaluated: the effect of a nuclear fuel reprocessing facility on lung cancer rates in surrounding counties, and the relation between air quality and pediatric emergency room visits due to asthma.

21.3.6

Scientific and Policy Limitations

In 1999, the Institute of Medicine (IOM), an arm of the National Academy of Sciences, recommended that in EJ cases where scientific information is incomplete, policymakers should take ‘‘reasonable precautions to safeguard against or minimize adverse health outcomes’’ (IOM 1999). When data are incomplete, policymakers should ‘‘exercise caution on behalf of the affected communities, particularly those that have the least access to medical, political, and economic resources.’’ IOM (1999) identified two major scientific limitations posing a barrier to crafting EJ policies: (1) lack of adequate data establishing a direct link between what some see as environmental hazards and specific adverse health effects and (2) better data needed regarding the roles environmental hazards play in creating health problems in specific population groups. Foreman (1998) notes that the limitations and drawbacks of EJ are seldom discussed. He concludes that empirical support for claims of disproportionate pollution impacts and discriminatory regulatory enforcement is actually much weaker than EJ advocates usually admit. EJ is driven by aspirations for community empowerment, for social justice, and for public health. These are difficult for federal policymakers to address effectively using environmental regulation. EJ advocacy may direct community attention away from those problems posing the greatest risks, having the ironic effect of undermining public health in precisely those communities it endeavors to help. Foreman (1998) argues that, if pursued aggressively, EJ may exacerbate aspects of environmental policymaking that have been widely bemoaned (such as economic inefficiency, muddled policy priorities, the gap between expert and public perceptions of risk, and local inflexibility on siting issues). Nevertheless, EJ advocacy can be instrumental in ensuring that all facts and perspectives are brought into public discourse.

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21.4 ENVIRONMENTAL JUSTICE AND CONTAMINANT REGULATION On Nov. 2, 1999, USEPA issued a proposed rule for radon in drinking water (USEPA 1999a). Regulation of radon and radiation risks in drinking water in general has equity implications. The proposed radon rule is the first drinking water rule to directly consider EJ issues, and illustrates some of the difficulties that can be faced. Jaworowski (1999) has presented an insightful review of radiation risk and ethics. Everyone is immersed in naturally occurring ionizing radiation. Exposure to radiation occurs from outer space and from radionuclides in rocks, buildings, air, and our own bodies. At least a billion particles of natural radiation enter our bodies every day. The individual dose rate of natural radiation the average inhabitant of earth receives is about 2.2 mSv (millisieverts) per year. In some areas, such as parts of India, Iran, and Brazil, the natural dose rate is up to a hundred times higher. Jaworowski (1999) argues that no adverse genetic, carcinogenic, or other malign effects of those higher doses have ever been observed among the people, animals, and plants that have ever lived in those areas. Radiation protection authorities apply a dose limit for the public of 1 mSv per year—less than half the average dose rate from natural radiation and less than 1% of the natural dose rates in many areas of the world. USEPA discusses EJ-related issues as part of its regulatory impact analysis associated with the proposed radon rule (USEPA 1999b). As part of USEPA’s responsibilities to comply with EO 12898, a stakeholder meeting was held via videoconference on March 12, 1998. Various components of pending drinking water regulations were addressed and how they may impact sensitive subpopulations, minority populations, and low-income populations. Participants included national, state, tribal, municipal, and individual stakeholders. Ideas were solicited from EJ stakeholders on known issues concerning current drinking water regulatory efforts, and key issues of concern to EJ stakeholders. Ways to increase representation of EJ communities in OGWDW regulatory efforts were solicited. Stakeholders raised concerns that the radon rule framework, including the multimedia mitigation (MMM) program coupled with an alternative maximum contaminant level (AMCL), may have a disproportionate impact on low-income and minority populations (USEPA 1999b). Key issues raised included (1) the potential for an uneven distribution of benefits across water systems and society, (2) the cost of air remediation to apartment dwellers, and (3) the concern that the approach could provide water systems and state governments a ‘‘loophole’’ through which to escape the responsibility of providing appropriate protection from radon exposures. USEPA considered equity-related issues concerning the potential impacts of MMM program implementation, concluding that there is ‘‘no factual basis to indicate that minority and low-income or other communities are more or less exposed to radon in drinking water than the general public’’ (USEPA 1999b). But a more general equity concern exists—the distribution of risk reduction benefits and costs across water systems and society will be uneven.

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Under the proposed radon rule, customers of community water systems (CWSs) complying with the AMCL (4000 pCi=L) will be exposed to a higher level of radon in drinking water than if the MCL (300 pCi=L) were implemented. These CWS customers would be spared the cost of installing treatment technology to comply with the MCL, but they, or another water system (or another party or agency), would have to pay at least part, if not all, of the cost for home indoor air remediation. Central treatment of drinking water would benefit everyone in the community, whereas home remediation would benefit principally the homeowners whose homes are remediated. From a national perspective, USEPA believes that home remediation would yield greater overall reductions in radon exposure (and more cancers avoided) than drinking water treatment. MMM programs developed by the state would have the flexibility to achieve the greatest risk reduction overall. However, areas with high indoor-air radon concentrations do not necessarily coincide with areas of high-drinking-water radon. The perception of injustice could occur, for example, if high-priced homes are remediated in an affluent area, at the expense of a low-income inner-city area. Customers in water systems meeting the AMCL might question whether their water is safe, since the MCL is so much lower. If the AMCL is indeed a safe level for radon in drinking water, customers in water systems meeting the MCL would justifiably wonder if they receive any real benefit for the cost of meeting the MCL. Small groundwater systems in rural areas are the most likely to be impacted by the radon rule. An EJ community could well be faced with a perplexing ethical decision: either pay the cost to meet the MCL and impose higher water rates on already financially stressed customers, or follow the state MMM program, meet the AMCL (allowing higher risks for customers), and let customers pay (most likely through taxes) for home remediation that might occur in another part of the state. If home remediation is paid for through state and=or federal programs that are funded with taxes, then customers in water systems meeting the MCL would pay a share of home remediation costs regardless. The National Academy of Sciences (NAS 1999) estimated the average outdoor air concentration for radon at 0.4 pCi=L, which serves as the basis of the AMCL. USEPA estimates that at the proposed MCL of 300 pCi=L, there is a statistical probability of 2 people in 10,000 contracting cancer after a lifetime of exposure, representing a 2  10 4 risk. But overall, radon in drinking water constitutes only about 1–2% of indoor-air radon exposure, caused mostly by soil gas. These considerations generated opposition to USEPA’s proposed radon MCL (Anonymous 1999, Danelski 1999, Mills 2000). Attempting to achieve small reductions in indoor-air radiation risks below that which occurs naturally outdoors, by regulating drinking water, is arguably impractical. Jaworowski (1999) asserts that the worldwide practice of protecting people from radiation with exceedingly prohibitive standards at excessive costs is absurd and immoral. Suggesting a commonsense approach, the fallacies in the assumptions inherent in the current radiation protection standards are reviewed. The principle of a practical threshold below which radiation doses should not require regulation is proposed. Overreaction to theoretical (actually imaginary) health-harming effects of

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radiation is characterized as unethical because funds are consumed that are needed to deal with real health problems. USEPA believes EJ issues for radon can be most effectively dealt with at the state and local levels with public participation. The proposed rule includes requirements for public participation in the development of MMM program plans, as well as for notice and opportunity for public comment. In developing MMM programs, states and CWSs would be required to document and consider all significant issues and concerns raised by the public. CWSs would be required to alert consumers to the MMM approach in their state in consumer confidence reports issued between publication of the final radon rule and the compliance dates for implementation of MMM programs. This requirement is intended to promote understanding of the health risks of radon in indoor air, as well as in drinking water, and help the public make informed choices.

21.5

IMPLICATIONS FOR WATER UTILITIES

Consumers now have more information regarding drinking water quality than ever before. A group expecting to be protected by federal, or state, EJ policy might well ask why they receive what they perceive to be lower-quality water (even if standards are met) than do other groups served by the same water system. EJ may emerge unexpectedly in regional water disputes and water supply projects. For example, in 1994, the city of San Diego, California, proposed to augment their local water supply by adding reclaimed wastewater from an advanced wastewater treatment facility to their San Vicente Water Supply Reservoir. After several years of study and evaluation, the California Department of Health Services granted conceptual approval of the project, with very stringent tertiary treatment and management requirements. The project had the support of many community groups, and was also supported by an independent Blue Ribbon Panel of Experts convened by the National Water Research Institute. Even so, public opposition to the project intensified in 1998. Opponents used the ‘‘yuck factor’’ and ‘‘toilet to tap’’ scenarios to argue against the project. Though refuted by the local water utility officials, concerns were expressed about the health hazards of ‘‘unknown contaminants’’ that could be introduced into the sewer system, but not subsequently removed by wastewater or drinking water treatment. More importantly, some opponents maintained that persons residing in that section of the city that would receive recycled water were primarily minorities. These opponents developed the rallying cry of ‘‘effluent from the affluent,’’ which soon elevated the environmental justice issue to the political level, both local and state. As a result, the City Council stopped all work on the project due to strong, organized opposition. EJ concerns present water utilities, USEPA, and other federal agencies with important opportunities and challenges:  USEPA, government agencies, and water utilities all must recognize that there is no definitive framework for evaluating EJ issues associated with a drinking

21.6 FUTURE OUTLOOK









21.6

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water regulation or water resource allocation within a particular area or within a particular water system. Additional policy research is needed to develop an appropriate framework for consideration and evaluation of EJ issues with a drinking water regulatory and water utility context. Without a generally accepted framework, undercurrents of racism or inequities (perceived or real) may occur, with no clear path for prevention or resolution. Meeting regulatory requirements set by USEPA and=or a state primacy agency and having regulatory agency support will not, in and of itself, guarantee that a major construction project will be acceptable to consumers, especially minority groups concerned about EJ issues associated with such a project. A carefully thought-out strategy for planning and developing the project, obtaining regulatory approval, and garnering support of consumers and community groups is critical for success, including consideration of equity and EJ issues. Water utilities should be cognizant of water quality variations across their distribution system, identifying areas of persistently poorer quality, and taking corrective action as needed. EJ stakeholders should be included along with other stakeholders, as appropriate, in decisionmaking processes, both in drinking water regulation development and by water utilities. The NEJAC Public Participation and Accountability Subcommittee has developed a model plan for public participation (NEJAC 1996). Water utilities and agencies should strive, within their available resources, to provide all customers drinking water that is safe and that is reasonably similar in quality across their service area. Disproportionate service to groups of customers should be eliminated, if possible. Precaution should be taken to not allow the ‘‘perception’’ of injustice to overwhelm a reality of fairness.

FUTURE OUTLOOK

EJ is emerging as an important consideration for water suppliers in terms of both regulatory policy and water utility decisionmaking. It will continue to play an important role in drinking water regulatory development under EO 12898 and the various regulatory actions taken by USEPA. The agency has a firm commitment to EJ and its integration into all programs, policies, and activities, consistent with existing environmental laws and their implementing regulations (USEPA 2001c). USEPA has encouraged states to develop strong EJ programs, and the agency will be publishing official guidance for state EJ programs. EJ initiatives at the state and local levels will continue (Olivo 1999). A few court cases have emerged involving decisions by regulatory agencies approving permits for waste management facilities in low-income areas, and permits for manufacturing plants that would emit air pollutants into a particular population area. But these cases do not definitely resolve key implementation issues. Instead, they highlight the potential controversies that arise out of EJ policy. Indeed, work

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remains in developing an appropriate framework to more fully consider EJ issues within a drinking water context.

REFERENCES Anderton, D. L. et al. 1994. Environmental equity: The demographics of dumping. Demography 31(2): 229–248. Anonymous. 1999. City fights U.S. caps for radon in water. The Arizona Daily Star (Dec. 14). Bauman, K. 1998. Direct Measures of Poverty as Indicators of Economic Need: Evidence from the Survey of Income and Program Participation. U.S. Census Bureau Population Division Technical Working Paper 30 (Nov.). Bauman, K. J. 1999. Extended Measures of Well-Being: Meeting Basic Needs. U.S. Census Bureau Current Population Reports, P70-67. Beecher, J. A. and P. E. Shanaghan. 1998. Water affordability and the DWSRF. J. Am. Water Works Assoc. 90(5):68–75. Bullard, R. D. 1984. Endangered Environs: The Price of Unplanned Growth in Boomtown Houston. California Sociologist 6:85–101. Carlin, B. P. and H. Xia. 1999. Assessing environmental justice using Bayesian hierarchical models: two case studies. J. Exposure Analysis Environ. Epidemiol. 9:66–78. CEQ. 1971. Environmental Quality. Washington, DC: Council on Environmental Quality. Clegg, R. 1998. Ending environmental injustice. Investor’s Business Daily (Dec. 15). Cole, L. W. and S. R. Foster. 2000. From the Ground Up: Environmental Racism and the Rise of the Environmental Justice Movement. New York: NY Univ. Press. Cooper, M. H. 1998. Environmental justice. In The CQ Researcher. Washington, DC: Congressional Quarterly, June 19. Danelski, D. 1999. EPA radon plans decried. The Press-Enterprise (Riverside, CA) (Dec. 22). Edin, K. and L. Lein. 1997. Making Ends Meet: How Single Mothers Survive Welfare and LowWage Work. New York City: Russell Sage Foundation. ELI. 2001. Opportunities for Advancing Environmental Justice: An Analysis of U.S. EPA Statutory Authorities. Washington, DC: Environmental Law Institute. EO. 1994. Executive Order 12898. Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations. Fed. Reg. 59:7629. Foreman, C. H., Jr. 1998. The Promise and Peril of Environmental Justice. Washington, DC: Brookings Institution Press. Freeman, A. M. 1972. The distribution of environmental quality. In Environmental Quality Analysis. A. V. Kneese and B. T. Bower, eds. Washington, DC: Resources for the Future. Heritage, J. 1992. Environmental protection—has it been fair? U.S. Environ. Protect. Agency J. 18 (March=April). IOM. 1999. Committee on Environmental Justice. Institute of Medicine. Toward Environmental Justice: Research, Education, and Health Policy Needs. Washington, DC: National Academy Press. Jaworowski, Z. 1999. Radiation risk and ethics. Physics Today 52(9):24–29. Johnson, B. 1998. Save Detroit’s development and minorities from eco-justice. The Detroit News (June 9).

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Kadak, A. C. 2000. Intergenerational risk decision making: A practical example. Risk Analysis 20(6):883–894. Lee, C. ed. 1992. Proc. First National People of Color Environmental Leadership Summit. New York: United Church of Christ. Liu, F. 2001. Environmental Justice Analysis; Theories, Methods, and Practice. New York: Lewis Publishers. Mastio, D. 1998a. Agency’s own study contradicts its attempt to link pollution and discrimination. Detroit News (May 27). Mastio, D. 1998b. Archer tackles the EPA: U.S. mayors back his call to suspend race-based policy. Detroit News (June 23). Mills, G. S. and K. S. Neuhauser. 2000. Quantitative methods for environmental justice assessment of transportation. Risk Analysis 20(3):377–384. Mills, W. R., Jr. 2000. EPA imposing huge penalty for radon on water districts. Letters to the Editor. The Orange County Register (Jan. 7). Mohai, P. and B. Bryant. 1992. Environmental racism: Reviewing the evidence. In Race and the Incidence of Environmental Hazards: A Time for Discourse. B. Bryant and P. Mohai, eds. Boulder, CO: Westview Press. NAPA. 1997. Deciding for the Future: Balancing Risks, Costs and Benefits Fairly across Generations. Washington, DC: National Academy of Public Administration. NAS. 1999. National Academy of Sciences. Risk Assessment of Radon in Drinking Water. Washington, DC: National Academy Press. NEJAC. 1996. The Model Plan for Public Participation. Developed by the Public Participation and Accountability Subcommittee of the National Environmental Justice Advisory Council. Washington, DC: USEPA. Olivo, A. 1999. Lawmakers focus on pollution in poor areas. Los Angeles Times (Sept. 27). Overholser, G. 1999. Environmental justice for all. The Washington Post (April 19). Pepper, J. 1998. Pollution rules stink for urban cities, minorities who need jobs. The Detroit News (May 31). Powell, D. L. and V. Stewart. 2001. Children: The unwitting target of environmental injustices. Pediatr. Clin. N. Am. 48:1291–1305. Rubin, S. J. 1998. A nationwide look at the affordability of water service. Proc. 1998 AWWA Annual Conf. Water Research Vol. C. Rubin, S. J. 1999. Assessing the Effect of the Proposed Radon Rule on the Affordability of Water Service. Washington, DC: American Water Works Association. Sexton, K. et al. 1993. Air pollution health risks: Do class and race matter? Toxicol. Industr. Health 9(5):843–878. Syme, G. J., E. Kals, B. E. Nancarrow, and L. Montada. 2000. Ecological risks and community perceptions of fairness and justice: A cross-cultural model. Risk Analysis 20(6): 905–916. UCC. 1987. Toxic Wastes and Race in the United States: A National Report of the Racial and Socio-Economic Characteristics of Communities with Hazardous Waste Sites. New York: United Church of Christ. USDA. 1997. U.S. Department of Agriculture. Household Food Security in the United States in 1995: Summary Report of the Food Security Measurement Project. Washington, DC: USDA.

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USEPA. 1992. Environmental Equity; Reducing Risk for All Communities. EPA 230-R-92-008. Washington, DC: USEPA. USEPA. 1998. Final Guidance for Incorporating Environmental Justice Concerns in EPA’s NEPA Compliance Analyses. Washington, DC, Oct. 15, 1998. (http:==es.epa.gov= oeca=ofa=ejepa.html). USEPA. 1999a. National Primary Drinking Water Regulations; Radon-222, Notice of Proposed Rulemaking. Fed. Reg. 64:59246–59378. USEPA. 1999b. Regulatory Impact Analysis and Revised Health Risk Reduction and Cost Analysis for Radon in Drinking Water. Washington, DC: USEPA Office of Ground Water and Drinking Water. USEPA. 2001a. Environmental Justice Home Page (http:==www.epa.gov=compliance= environmentaljustice=index.html). USEPA. 2001b. USEPA Environmental Justice Frequently Asked Questions (http:==www. epa.gov=compliance=resources=faqs=ej=index.html). USEPA. 2001c. Memorandum from Administrator Whitman Regarding EPA’s Commitment to Environmental Justice. August 9. USGAO. 2002. Report to Congressional Requestors. Community Investment; Information on Selected Facilities the Received Environmental Permits. GAO-02-479. Washington, DC: U.S. General Accounting Office. USNRC. 1997. Final Decision—Louisiana Energy Services Docket 5=1=97. Rockville, Maryland: U.S. Nuclear Regulatory Commission (http:==www.nrc.gov=OPA=reports= lesfnl.htm).

22 WHAT WATER SUPPLIERS NEED TO KNOW ABOUT TOXIC TORT LITIGATION KENNETH A. RUBIN, Esq. Morgan Lewis and Bockius, L.L.P., Washington, DC

22.1

INTRODUCTION

It is a city or private water supplier’s worst nightmare: being sued by hundreds, possibly thousands, of customers because something is allegedly wrong with the water. The popularity of movies like A Civil Action and Erin Brockovich, coupled with the first-time-ever disclosures about water quality set forth in Consumer Confidence Reports, will make these nightmares a reality for some utilities. Imagine that you, as a water utility manager, opened the mail and read a complaint that began as follows: NOW COMES the Plaintiff, ——— (the ‘‘Plaintiff’’), by counsel, and hereby moves this Court for judgment against the defendant, the City of ———, on the grounds and for the relief hereinafter set forth: SUMMARY OF THE PLAINTIFF’S CLAIMS 1. The City of ——— or the (——— ‘‘City’’) knowingly, recklessly, wantonly, and=or negligently poisoned the Plaintiff and her unborn child by causing the Plaintiff unknowingly and unwittingly to drink, shower in, bathe in, and otherwise use domestic Drinking Water Regulation and Health, Edited by Frederick W. Pontius. ISBN 0-471-41554-5 # 2003 John Wiley & Sons, Inc.

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water supplied by the City that was contaminated with dangerous toxins known as trihalomethanes (‘‘THMs’’). As a direct result of drinking and otherwise using water contaminated with trihalomethanes, the city caused the Plaintiff to suffer a spontaneous abortion=miscarriage and to lose her baby. At all relevant times, the city knew or should have known of (i) the presence of trihalomethanes in its water; and (ii) the harmful and toxic effects of trihalomethanes on persons exposed to them. Despite this knowledge, the City failed to rectify this problem, which it could and should have resolved. Worse yet, the City attempted to cover up the problem by issuing inadequate and misleading information to the citizens of ———, including the Plaintiff, rather than warning of the true nature and extent of the danger to those exposed to the water supplied by the City. Consequently, this litigation is brought to recover all damages related to the presence of THMs in the water supplied by the City and used by the Plaintiff.

After another 20 pages of detailed allegations that never establish a violation of the pertinent MCL, the complaint recites 13 different theories for recovery of damages. The 13 counts are (1) breach of contract=warranty, (2) battery, (3) negligence, (4) negligence per se, (5) violation of implied warranty of merchantability, (6) violation of implied warranty of fitness for a particular purpose, (7) Consumer Protection Act violation, (8) nuisance, (9) trespass, (10) actual fraud, (11) constructive fraud, (12) fraudulent concealment, and (13) misrepresentation. The complaint concludes with a request for compensatory damages in the amount of $5 million plus punitive damages in the amount of $1 million. Now imagine that several dozen women have filed virtually identical complaints. The language presented above is from one of about 60 similar, individual complaints filed in state court in Virginia against the City of Chesapeake in 2001. If sued, what should a water utility expect, and what are the best defenses? These questions are answered in this chapter. The basics of toxic torts are addressed, as well as different theories and mechanisms of recovery that plaintiffs might employ, and what to expect during the course of litigation—discovery, motions, practice, and trial. Several possible defenses are identified for defendants, with attention given to those that the courts have recognized as especially important to water suppliers.

22.2

BASICS OF TOXIC TORTS

A ‘‘tort’’ is a lawyer’s term for a wrong that is civil in nature that is done to persons or property. Black’s Law Dictionary defines a tort as ‘‘a private or civil wrong or injury . . . for which the court will provide a remedy in the form of damages’’ (Garner 1990). Tort law, like other areas of law such as contracts, has goals. The general goals of tort law are (1) assignment of responsibility, in money damages or equitable relief, to those responsible for creating a risk that produces harm; (2) compensation of persons for loss caused by another’s tortious conduct, including concepts of corrective justice or fairness; (3) deterrence of further unreasonably hazardous conduct by the responsible party and others engaged in similar pursuits; and (4) encouragement of innovative practices that will reduce or eliminate unreasonable hazards (Boston and Madden 1994). What this means is that courts will identify

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some threshold standard of care to which people and businesses alike must adhere, and in the event that a person or business is determined not to have met that standard, an injured party may be compensated for its loss. The standard of care is generally set forth by a judge in instructions to a jury. In short, the judge tells the jury what the standard is, and it is up to the jury to assess the facts that they have learned during the trial against that standard. One of the most troubling aspects about toxic tort litigation is the absence of a clear, uniform standard. Unlike, for example, the precise maximum contaminant levels set by the U.S. Environmental Protection Agency (USEPA), the standard of care defined by a judge will vary from state to state and often be interpreted differently by different judges. It is the trier of fact, usually the jury, that determines whether the defendant has met that standard and, if not, what damages the defendant should pay to the plaintiff. In addition to damages meant to compensate the injured party for its loss, called ‘‘compensatory damages,’’ there is often the possibility that a jury may award ‘‘punitive damages.’’ In theory, punitive damages are intended to both punish the offender and deter others from similar types of offending behavior. In practice, punitive damages often far exceed any reasonable amount to achieve such goals, and result in unjustly enriching the plaintiff and plaintiff’s counsel at the expense of the defendant and the public it serves. Toxic torts are just one type of tort and follow the general goals of tort law. They are called ‘‘toxic torts’’ because they deal specifically with injuries caused by toxic substances. A toxic tort claimant frequently seeks recovery under a variety of legal theories, such as strict liability for abnormally dangerous activities, negligence, trespass, or nuisance. Toxic tort plaintiffs also seek remedies under contract theories in addition to those that sound in tort, which are also commonly referred to as ‘‘toxic tort claims’’, although technically they are breach of contract claims. For example, a group of cases out of Pennsylvania state courts allowed recovery based on claims brought under the Uniform Commercial Code (UCC), or state analog, for the sale of goods or under statutory creation of a dangerous condition (Gall et al. 1989). Gall was the first case decided in the Supreme Court of Pennsylvania that allowed claims by individuals allegedly ill with giardiasis as a result of drinking contaminated tapwater to be brought under the UCC. The focus of the Gall complaint was that ‘‘plaintiffs became ill with giardiasis and other diseases because the defendants failed to utilize the latest scientific developments to treat and cure water, [and] failed properly to filter the water, failed properly to protect water retailing systems and water-piping devices to eliminate giardia, failed to take frequent and necessary water samples.’’

The Gall court first held that the government, the City of McKeesport, was not immune from suit because it had a dangerous condition that created a reasonably foreseeable risk about which the city had been or could be charged with actual notice. The court then further held that as to the UCC claims, water falls into the definition of ‘‘goods’’ under the statute and therefore there is an implied warranty of merchantability that the city breached.

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Each theory of liability, listed and defined in Table 22.1, has a different threshold of proof and elements that must be proved. Some theories are limited by prenotification requirements and statutes of limitations that make them less attractive to plaintiffs than other causes of action. Like an army that launches a dozen missiles, where only one need get by its opponent’s defense, plaintiffs likewise will rely on an arsenal of varying theories of recovery with the hope that at least one cause of action will survive the defendant’s motions to dismiss. In most cases, the plaintiff must prove that the defendant was negligent or at fault. The plaintiff must show that (1) the defendant had a duty of care to the plaintiff, (2) the defendant breached that duty, (3) the defendant’s breach of that duty was the cause of plaintiff’s injury, and (4) the plaintiff sustained damage for which he=she should be compensated. The determination whether the defendant was negligent in the observance of this duty of care is judged under the ‘‘reasonable person’’ standard. This standard is implemented almost exactly as it is defined; the judge or the jury asks the following question: What would a reasonable person of average intelligence have done in this situation? Once the standard is determined, the defendant’s conduct is compared to the standard; if he=she meets it, he=she is not negligent, but if his=her conduct falls short of the standard, he=she is deemed to have been negligent. Plaintiffs often seek to bypass the need to establish negligence by asking the court as a matter of law to rule that the defendant be judged by a strict liability standard. Under this test the exercise of due care by the defendant is irrelevant to the inquiry; thus, it is no defense that the defendant was not negligent. In strict liability all the plaintiff must show is that the activity of the defendant was the cause of his=her injury and that he has been damaged. If it is either determined that the defendant was negligent or strict liability applies and fault is not an issue, the inquiry continues as to whether the defendant’s conduct was the cause of the plaintiff’s injury. Thus, for example, a state court in Wisconsin cited the question of causation in a drinking water case filed by citizens allegedly injured by releases of Cryptosporidium into the water supply as ‘‘did the claimant suffer injury, and, if so, was it caused by the Cryptosporidium infestation’’ (Markweise 1996). Toxic torts often involve injury or damage that remains undiscovered for years after exposure to the contaminant, creating a substantial hurdle for plaintiffs. Because of these long latency periods between exposure and injury, toxic torts usually involve complex questions of medical and scientific causation. The toxic tort plaintiff must prove that the defendant’s product or activity was the direct cause of the resulting personal injury or property damage. The plaintiff must show that ‘‘but for’’ the defendant’s conduct, the injury would not have occurred. This is often difficult because there may be any number of other explanations—natural causes, heredity, voluntary choices the plaintiff made with respect to diet and other lifestyle factors—as to why the plaintiff contracted the particular illness at issue. Exposure to chemicals may have caused the injury, but that exposure may have been from cigarette smoke, industrial air pollutants, chemicals found in garden products, or hundreds of other possibilities that do not involve drinking water. Unlike a car accident, which is an event from which the causation of injury is often immediately

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TABLE 22.1 General of Theories of Liability Breach of contract or warranty. A breach by a seller of the terms of a contract or warranty (as by the failure of the product to conform to the seller’s description). A breach of warranty is sometimes referred to as ‘‘strict liability’’ because a seller may be liable for a breach of warranty even without any negligence or misconduct. Battery. Touching or hitting someone, intentionally or recklessly, without their permission (usually hitting someone, but would include other harmful contact, such as administering a poison). Negligence. Failure to exercise the degree of care expected of a person of ordinary prudence in like circumstances in protecting others from a foreseeable and unreasonable risk of harm in a particular situation. Negligence per se. Negligence that consists of a violation of a law specifically intended to protect the plaintiff from the type of injury alleged in the complaint. Violation of implied warranty. In contrast to an express warranty—one that is a clearly stated promise in a contract, such as a product sales agreement, which states that the product is as represented (as in being free from defective workmanship) and that gives specifically grants the customer (the ‘‘warrantee’’) recourse against seller (the ‘‘warrantor’’), an implied warranty is automatically imposed by statute—it is not expressly stated in a private contract. In this cause of action the plaintiff must first establish the defendant’s actions—under state or federal law—created an implied warranty, and that the defendant broke the warranty. This may be a general implied warranty of merchantability that guarantees that goods are reasonably fit for their ordinary purpose, or, a narrower and more specific, implied warranty for a particular purpose. To establish a claim of breach of implied warranty for a particular purpose, the buyer must prove the seller knew the purpose or which goods were being bought and that the buyer relied on the seller’s skill. State consumer protection act violation. A state may offer specific protections to consumers covering any product sold in the state, that offers protection in addition to any warranties, and notwithstanding any attempts by a seller to narrow or eliminate the scope of an implied warranty. Nuisance. An activity that invades or interferes with another’s rights or interests, typically the use or enjoyment of property, by being offensive, annoying, dangerous, obstructive, or unhealthful. This began as a common law concept used by plaintiffs seeking injunctions against polluting activities before the enactment of environmental legislation that, for the most part, has replaced nuisance claims. Trespass. Most often refers to entering another person’s property without permission, but also refers to any physical action that invades or interferes with another person. Actual fraud. Fraud committed with the actual intent to deceive and injure another. Constructive fraud. Conduct that a judge would consider fraudulent under the law even in the absence of an intent to deceive because it has the same consequences as an actual fraud. Fraudulent concealment. The intentional failure to disclose important information that causes injury to the plaintiff who was harmed by the absence of that information. Misrepresentation. A false representation that could be innocent or deliberate fraudulent deception, either by direct act, or by nondisclosure, resulting in harm to those who rely on it.

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obvious, the long latency periods between exposure and the manifestation of injury and the enormous number of possible causes, including natural causes, create huge barriers to the toxic tort plaintiff seeking to prove something in drinking water caused an injury. The long latency period between exposure and the manifestation of the alleged injury also create factual and legal disputes over the applicable statute of limitations. Plaintiffs will contend that Congress has eliminated one major barrier arising under some state statutes of limitations. The federal Superfund law added Section 309 in 1986, which preempted state statutes of limitations so that the ‘‘commencement date’’ for any action brought under state law for personal injury, or property damages, allegedly caused by exposure to any hazardous substance, is the date when the plaintiff knew (or reasonably should have known) that the injury was caused by the alleged substance (CERCLA 1986). Whether this applies to public water systems in the absence of a Superfund site is an issue that is likely to be raised in many places. 22.3

WHAT PLAINTIFFS MUST PROVE

To succeed in bringing a toxic tort against a water supplier, a plaintiff must make certain proofs to make drinking water the basis for a toxic tort, including elements of causation. 22.3.1 Does the Water Contain a Contaminant, and Has the Plaintiff Been Exposed to It? A plaintiff must first establish that he or she has been exposed to allegedly contaminated water. This is often not a high threshold to meet because many water supplies contain a wide variety of contaminants—some natural, some human-made (synthetic). Indeed, Consumer Confidence Reports now reveal, and confirm, the presence of various substances in drinking water. Exposure is easy to prove—a person might drink contaminated water, swim in it, and breathe it in the shower. 22.3.2

Is the Level of the Contaminant Sufficient to Cause Harm?

While all water supplies will contain some substances in addition to pure molecules of water, the major issues are (1) at what concentrations, (2) for what duration at these concentrations, (3) what is the total quantity of each contaminant ingested by each plaintiff, (4) what general scientific evidence exists (if any) that ingestion of such quantities can cause the harm alleged by the plaintiffs, and (5) what specific evidence exists (if any) that such ingestion was the specific cause of the plaintiff’s injuries. 22.3.3

Has that Contaminant Caused the Injury?

Different types of events may result in contamination concerns and possibly provoke legal action—some obvious, others very difficult to discern. The most likely event to

22.3 WHAT PLAINTIFFS MUST PROVE

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trigger a toxic tort suit is a sudden one, where many individuals simultaneously exhibit obvious personal injury of a type associated with drinking contaminated water. For example, a group of inhabitants simultaneously suffers some type of immediate and acute gastrointestinal reaction to exposure to a substance that is determined to be present in the water supply system. This acute reaction is often a physical one that causes the individual to seek medical attention, thus enhancing the likelihood of discovering the cause of the illness soon after exposure to the contamination. Persuading a jury that the drinking water is the cause of a common problem suddenly afflicting many people in a community would be relatively easy in that instance. For a latent reaction, however, carrying the burden of proof is much more difficult to show that something in the water caused an injury to people many years after exposure. There, the injury is of a type that would not have been immediately obvious at the time of exposure and that could be caused by many factors, not just water. More than ever before, the issue of causation can be a toxic tort defense attorney’s most effective tool. It is by now well established that plaintiffs are required to demonstrate both general and specific causation to a reasonable degree of medical or scientific certainty to prove their claims. The linchpin to such proof inevitably entails the use of expert testimony in many different areas of science and=or medicine. The expert witness plays a vital role in toxic tort litigation—in a typical case, the plaintiff cannot win unless its experts are reliable and convincing and the court allows their testimony to be heard by the jury. The U.S. Supreme Court has given significant attention to the issue of the admissibility of expert testimony in the 1990s, with a trilogy of cases that provide defense counsel with new means to challenge such testimony and thereby defeat plaintiffs’ causation burden. First, the Supreme Court issued an opinion in the case of Daubert v. Merrell Dow Pharmaceuticals, Inc., in which it considered the admissibility of expert testimony based on test tube and animal studies showing a link between Bendectin and certain birth defects (Daubert 1993). The U.S. Supreme Court in Daubert rejected the longstanding ‘‘general acceptance’’ test, established in 1923 in the case of Frye v. United States (Frye 1923), holding that the Frye test was superseded by Rule 702 of the Federal Rules of Evidence (Daubert 1993). In Frye, the Court of Appeals for the District of Columbia ruled certain scientific evidence inadmissible because it had ‘‘not yet gained such standing and scientific recognition . . . as would justify the courts in admitting expert testimony deduced from the discovery, development, and experiments thus far made’’ (Frye 1923).

Some states still follow the Frye test. Instead of the seemingly rigid ‘‘general acceptance’’ test, the Court interpreted Rule 702 to require a ‘‘standard of evidentiary reliability.’’ Federal Rule of Evidence 702 provides, in pertinent part: ‘‘If scientific, technical, or other specialized knowledge will assist the trier of fact to understand the evidence or to determine a fact in issue, a witness qualified as an expert . . . may testify thereto in the form of an opinion or otherwise.’’

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To evaluate the reliability of proffered scientific expert testimony under Rule 702, the Court identified the following relevant factors: (1) the testability of the proffered scientific theory, (2) whether the scientific opinion has been published or subjected to peer review, (3) the error rate of the technique, and (4) whether the opinion is generally accepted in the relevant scientific community (Daubert 1993). While Daubert was initially viewed by many as a plaintiff’s victory, it has since proved very favorable to defendants seeking to exclude novel or unreliable testimony. Most important, the Daubert opinion placed great emphasis on the role of the trial judge as a ‘‘gatekeeper,’’ affording sophisticated and creative defense counsel an expanded basis on which to challenge expert testimony. In 1997, the Supreme Court issued the second opinion in the trilogy, clarifying that Daubert did not alter a reviewing court’s standard of review with regard to a district court’s decision to admit or exclude scientific evidence (General Electric 1997). The Court reversed the ruling of the court of appeals, which had applied ‘‘a particularly stringent standard of review to the trial judge’s exclusion of expert testimony.’’ The Court held that the abuse of discretion standard, not a heightened standard, would apply. The Court then held that the district court did not abuse its discretion in excluding the testimony of plaintiff’s expert witnesses. The Court also clarified that, despite Daubert’s focus on an expert’s methodology, as opposed to an expert’s conclusions, ‘‘[a] court may conclude that there is simply too great an analytical gap between the data and the opinion proffered,’’ and thus exclude the evidence. Most recently, in 1999, the Supreme Court issued the third opinion in the trilogy, expressly holding that all technical or specialized expert testimony, regardless of whether it is ‘‘scientific,’’ is subject to the Daubert standard (Kumho 1999). In the wake of the Supreme Court rulings, courts also are giving more attention to the process of determining whether scientific, technical, or specialized evidence is admissible. In a Sixth Circuit case, the court of appeals affirmed a district court decision excluding the testimony of plaintiffs’ two expert witnesses in a suit alleging injury caused by PCB contamination from a natural gas pumping station. The district court properly considered the lack of peer review and publication of one expert’s study because, the court of appeals agreed, such a factor was relevant to whether that expert’s causation theory was based on good science. Further, the district court properly concluded that flaws in the methodology used by one expert failed to show that PCB exposure, and not other factors that have similar symptoms, caused the individuals’ injuries. The record was replete with evidence of other factors or agents that could have caused the injuries, but the expert failed to examine if any of these factors caused the individuals’ injuries. Thus, there was no factual basis for his conclusion that PCB exposure caused the injuries. Likewise, the second expert’s conclusion that PCB exposure caused the injuries was not based on scientific knowledge. The defendant showed that the plaintiffs’ expert had no knowledge of the individuals’ PCB exposure, and he failed to account for other factors that may have caused the injuries. The case was decided without an evidentiary hearing. The plaintiffs were not given an opportunity to cure the deficiencies in their experts’ testimony (Nelson 2001).

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In Castellow v. Chevron USA, the trial court considered the proposed opinions of several experts that occupational exposure to benzene caused a fatal blood disease (Castellow 2000). Noting that Daubert required trial judges to act as gatekeepers, and thus bar the use of ‘‘junk science’’ in the courtrooms, the trial judge would not admit opinions of the plaintiffs’ medical experts because they were not supported by relevant scientific or medical literature. In light of these decisions, defense counsel should prepare to subject all types of specialized expert testimony to challenges under Daubert, as the trial judge has significant discretion in whether to admit or exclude such evidence. Defense counsel also should be prepared to present challenges to such evidence early in the proceedings and to press their positions to full advantage in Rule 104 hearings, seeking to have the Court exclude the evidence before there is any risk that a jury may hear it. In addition to challenges to the admissibility of expert testimony, defendants also should press courts to question the utility of such testimony and to reject it where the testimony is nonconclusive or insufficient to demonstrate specific causation. For example, in Rutigliano v. Valley Business Forms, a former office worker sued the manufacturer of carbon paper, alleging that she developed ‘‘formaldehyde sensitization’’ from exposure to formaldehyde in the paper (Rutigliano 1996). Defendants challenged the plaintiff’s proof of causation, arguing that the plaintiff’s expert did not prove general or specific causation. The Court first rejected the plaintiff’s proof of general causation, holding that the plaintiff’s expert did not meet the Daubert standard for admission, as his conclusions were based primarily on subjective experience. In addition, the Court found that plaintiff failed to prove specific causation because she did not prove that some other substance did not cause her injury. Because the plaintiff failed to disprove other potential causes for her injury, the Court dismissed the defendant manufacturers on summary judgment. Thus, plaintiffs must prove not only general causation (i.e., that the substance can cause the alleged injury) but also prove specific causation (i.e., that the substance did cause the alleged injury) by, among other things, eliminating other possible causes for the injury. Defendants also have argued successfully that proof of exposure to a toxic substance is not sufficient to prove causation; plaintiffs must prove exposure to a dosage sufficient to cause the alleged injury. In Wright v. Willamette Industries, Inc., for example, residents near a manufacturing plant brought a negligence action against the plant owner, claiming damage from exposure to plant emissions. The court required plaintiffs to prove the dose of their alleged exposure, as well as the dose considered hazardous to humans. Despite evidence of exposure, the Court excluded plaintiffs’ evidence of causation because they produced only speculative evidence regarding the level of exposure actually hazardous to humans. On that basis, the Court reversed a lower-court judgment for plaintiffs. Defendants and courts also are becoming more adept at analyzing and assessing plaintiffs’ attempts to prove causation through epidemiologic studies. Epidemiologic studies are used to assess whether there is a statistical relationship between exposures to certain substances and the occurrence of certain health conditions. The most important thing a defense attorney must understand about evidence based on epidemiology is that even a strong statistical association between an exposure and a

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disease does not prove that the exposure is capable of causing, or did indeed cause, the disease. Further, even epidemiologic studies showing strong associations between an exposure and a disease should be critically evaluated for characteristics that can create unreliable results. More recent case law provides evidence of the courts’ increased awareness of the problems inherent in epidemiologic studies and their increased willingness to exclude misleading or unreliable testimony based on such studies. Courts are beginning to understand that an expert’s testimony that an association proves causation is not determinative. Instead, urged on by developments in the law, trial courts are critically evaluating epidemiologic evidence according to criteria widely used by epidemiologists. For example, the Hill criteria, a frequently cited set of guidelines to evaluate epidemiologic evidence, assess the following: the strength of the association, whether the association has been consistently observed, whether the association is specific (i.e., limited to a particular subset of the population in a particular location), whether the exposure precedes the disease, whether the association reveals a biological gradient (i.e., an increased risk of disease with an increased dose), whether there is a plausible biological mechanism for the relationship, whether the association makes sense given what we know about the disease, and finally, whether there is laboratory evidence consistent with the association. Defendants have focused the courts on the Hill criteria as a tool to assess the reliability of epidemiologic evidence. In Merrell Dow Pharmaceuticals, Inc. v. Havner, plaintiffs presented epidemiologic evidence to prove that Bendectin caused their child’s injuries (Merrell 1997). The Court recognized, however, that the evidence proved only an association, not causation, and proceeded to evaluate the evidence according to the Hill criteria. The Court ultimately found for the defendant, holding that the evidence presented was insufficient to prove causation. Specifically, the Court stated (Merrell 1997): To raise a fact issue on causation and thus to survive legal sufficiency review, a claimant must do more than simply introduce into evidence epidemiologic studies that show a substantially elevated risk. A claimant must show that he or she is similar to those in the studies. This would include proof that the injured person was exposed to the same substance, that the exposure or dose levels were comparable to or greater than those in the studies, that the exposure occurred before the onset of injury, and that the timing of the onset of injury was consistent with that experienced by those in the study.

In Lofgren v. Motorola, the court used the Hill criteria to evaluate and exclude all of plaintiff’s epidemiologic evidence. As reflected in the preceding discussion, the Supreme Court’s decisions in Daubert, Joiner, and Kumho have increased recognition of the trial judge’s critical role in assessing the admissibility and reliability of expert testimony on general principles of causation. With the attention given to the judge’s gatekeeping function, defendants increasingly can, and have, used summary judgment motions and Rule 104 hearings to demonstrate the flaws in the opinions of plaintiffs’ proffered expert witnesses and to demonstrate plaintiffs’ fatal failure to prove the specific causation necessary to establish their claims.

22.4 KEY STEPS IN LITIGATION

22.4

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KEY STEPS IN LITIGATION

There are several key steps in the litigation process and special considerations for class action suits, described in this section. A general summary of progression of a toxic tort case is provided in Figure 22.1.

22.4.1

In the Beginning

A lawsuit begins with a complaint, perhaps like the one mentioned on the first page of this chapter. In some cases, this will be preceded by a notice of claim against a governmental water supplier, or, for non-governmental suppliers, letters threatening legal action. Plaintiffs’ counsel often seeks to file class actions to pursue toxic tort claims on behalf of a large number of plaintiffs, rather than filing many separate cases (Pagliaro et al. 2000). From the defendant’s perspective, class actions require careful consideration of settlement options and litigation strategy because of the public attention and enormous economic threat posed by the aggregation of what may otherwise be marginal claims. Class actions are not automatic; a judge must approve the plaintiff’s motion

Figure 22.1

General progression of a toxic tort case.

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to certify a class, considering the factors set forth in Federal Rule of Civil Procedure, Rule 23(b), or its state analog. It is often wise to challenge the certification of a class to avoid this extremely time-consuming and expensive breed of litigation. On the other hand, there are certain situations where defendants may view class treatment as beneficial. In this section, we will provide an overview of the requirements for maintaining a class action, and then will review the pros and cons to class certification. A review of case law discussing class certification will illuminate successful strategies for opposing class certification. 22.4.2

Threshold Requirements for a Class Action

Rule 23(a) of the Federal Rules of Civil Procedure lists four threshold requirements applicable to all class actions: 1. Numerosity (the class is so numerous that joinder of all members is impracticable) 2. Commonality (there are questions of law or fact common to the class) 3. Typicality (the claims or defenses of the representative parties are typical of the claims or defenses of the class) 4. Adequacy of representation (the representative parties will fairly and adequately protect the interests of the class) The class must also be maintainable under either Rule 23(b)(1), (b)(2), or (b)(3). Rule 23(b)(3) is the section most often applied in toxic tort actions, and requires that the class show that common questions of law or fact predominate over individual issues and that a class action is superior to other available methods of adjudication. The Rule 23(b)(3) ‘‘predominance’’ analysis is often very similar to the Rule 23(a)(3) ‘‘typicality’’ requirement. The question of superiority is often determined by predicting the manageability of the resulting class and case. All Rule 23(b)(3) class members have the right to ‘‘opt out’’ of the class, preserving the ability to bring a claim in an individual suit. A full discussion of the basic Rule 23 requirements for maintaining a class action is beyond the scope of this chapter. For a thorough review of those requirements, refer to Haig (1998). Defending class actions can be extremely time-consuming and expensive. Because of the many procedural steps involved, a class action may last upward of 10–15 years. Even where defendants ultimately succeed, defendants may suffer from the flurry of adverse publicity often surrounding class actions. Further, defendants’ task is all the greater because of the great procedural advantages plaintiffs obtain from invoking Rule 23. Most notably, the class obtains broad discovery rights, permitting a limited group of class representatives to obtain discovery that may be used for hundreds of claims. In addition, the statute of limitations as to the claims of absent class members may be tolled, preserving the possibility of numerous individual claims if the class is not certified. On the other hand, there are potential advantages to class treatment that defendants should consider before embarking on a battle to defeat class certification.

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When serial litigation is the alternative to defending a class action, it may be less costly and time-consuming to defend a single class action. A class action also affords the possibility of obtaining broad res judicata protection against future claims and avoiding a repeated threat of punitive damages. The fact that class treatment affords res judicata protection does not mean that a defendant does not have to address the merits of each plaintiff’s case. For example, in In re TMI Litigation (TMI 1996) the district court dismissed the cases of the 2000 plaintiff class after 10 ‘‘test’’ plaintiffs failed to prove exposure to at least 10 rem of ionizing radiation on the basis of its conclusion that the scientific literature showed a consensus that the causal link between exposure and cancer below 10 rem was speculative. The court of appeals reversed the ruling, disagreeing that the scientific literature showed such a consensus and holding that the remaining plaintiffs should have the opportunity to prove that exposure to doses below 10 rem could have caused their current conditions (TMI 1999). Potential exposure for punitive damages to an entire class of plaintiffs could lead to enormous damages. In one of the most widely publicized tobacco class actions, a Florida appeals court reversed its original decision and held that the jury could proceed to decide the punitive damages phase on a classwide basis (Reynolds 1999). Finally, there is sometimes a benefit from the certainty—good or bad—afforded with the resolution of a class action. In determining whether to attack class certification, defendants should weigh these pros and cons, carefully considering the number of individual cases likely to arise in the absence of a class action. Of course, defendants should recognize that class certification is often pursued where there are many small or weak claims, and that opt-out rights under Rule 23(b)(3) still allow plaintiffs with strong claims to sue independently of the class. Despite a trend in the 1980s and early 1990s of increased use of the class action as a vehicle to adjudicate toxic tort claims, the trend is now starting to swing away from the use of this device. The U.S. Supreme Court’s decision in Amchem Products v. Windsor epitomizes this trend (Amchem 1997). The Supreme Court engaged in a very thorough analysis of the class certification issue and then declined to certify a settlement class of persons who were either suffering from asbestos-related injuries or who had been exposed to asbestos and were at risk of suffering future injuries. Under the terms of the settlement under review, persons currently suffering from asbestos-related injuries would be compensated for their injuries, and persons exposed to asbestos and at risk of future injury could qualify for certain future benefits. The Court was troubled by the fact that class members were exposed to different doses, over different lengths of time. Some class members had no current injury, some suffered from asbestosis, and some suffered from lung cancer. Some members had a history of smoking, while some had never smoked. In part because of the widely varying circumstances of the class members, the Court rejected the class, holding that common questions did not predominate. In addition, the Court held that the class did not meet the Rule 23(a)(4) requirement of adequate representation, as the interests of the class were not aligned. For example, while the interest of those with current injuries is to get a large lump-sum payment, the interest of those without current injuries is to obtain relief in the form of future medical

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monitoring, ideally in a way that accounts for inflation and future medical technology. Thus, the Court affirmed the Third Circuit decision rejecting the Rule 23(b)(3) class. Because of the numerous fact issues always involved in toxic tort cases, defendants wanting to challenge class certification have a very strong argument. As discussed in Amchem, especially where there is no single sudden event, defendants opposing class certification may almost always attack certification on the basis that the class does not meet the typicality and adequacy of representation requirements of Rule 23(a). Given the huge spectrum of exposures, dosages, and injuries at issue in most toxic tort suits, it is possible that no set of representatives could be ‘‘typical’’ of the proposed class. For example, a state judge in Maine refused to certify a class of property owners who sought damages for MTBE contamination of their water wells, finding ‘‘individual issues of reliance, causation, comparative negligence and damages overwhelm this case.’’ Maine’s Supreme Court, carefully explaining its decision, dismissed an appeal (Millett 2000). In addition, potential conflicts of interest abound in toxic tort cases, making the adequacy of representation vulnerable to challenge. For example, the differing strengths of plaintiffs’ claims create tension within the class, as weaker claims may risk the success of stronger claims (Amchem 1997). In addition, plaintiffs with differences in the severity and types of injury may have different priorities with regard to settlement and their requested damages. Finally, the adequacy of representation is also subject to challenge where there are subsets of plaintiffs that are vulnerable to affirmative defenses. In addition to challenging the typicality and the adequacy of representation, courts are increasingly holding that a class in toxic tort actions fails to meet the predominance requirement in Rule 23(b). Causation is an issue that is almost impossible to generalize across a class of plaintiffs. There is rarely a single event causing the damage claimed, and almost never a proximate cause that pertains to all class members or injuries. Thus, defendants can almost always challenge class certification on the basis that causation in a toxic tort case is an individualized inquiry, not suited to class treatment. In Reilly v. Gould, Inc. (Reilly 1997), the Court declined to certify class of individuals living near a battery crushing facility and noting that causation must be assessed ‘‘property by property and individual by individual.’’ In Thomas v. FAG Bearings Corp. (Thomas 1994), the Court declined to certify class allegedly exposed to contaminated groundwater due to predominance of individual causation issues. Finally, defendants may also challenge class certification under the Rule 23(b)(3) superiority requirement. Often, the sheer size of the class and the complexity of the issues involved makes class treatment unmanageable. Class certification could result in an unwieldy discovery process and could create considerable inefficiencies as the court must separate the common issues from the individual issues. Further, despite certification, the courts will still have to devote resources to opt-out cases, which could be significant in number. Thus, defendants also should analyze critically the manageability of certifying a given class.

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Often, all the problems associated with certifying a given class will not be apparent at the outset of a litigation. In the case that the court initially certifies a class, a defendant may always file a motion to decertify. In addition, Rule 23(f) now provides the opportunity, albeit discretionary, for immediate appeal of certification issues. Rule 23(f) of the Federal Rules of Civil Procedure provides: ‘‘A court of appeals may in its discretion permit an appeal from an order of a district court granting or denying class action certification under this rule if application is made to it within ten days after entry of the order. An appeal does not stay proceedings in the district court unless the district judge or the court of appeals so orders.’’

22.4.3

Discovery

Before trial, the parties engage in a process called ‘‘discovery’’ to learn more about the strengths and weaknesses of their opponent’s case. While there will be numerous issues, the plaintiff’s focus will be proving causation while the defendants will seek to disprove causation and identify alternative causes for the injury to the plaintiff. Indeed, the defendants should seek discovery before the court rules on a motion to certify the class, in order to obtain facts that will help them show that the case is not suitable to proceed as a class action. Discovery takes the form of document requests, interrogatories, and depositions. A plaintiff might seek the following type of information:      

Defendant’s knowledge of the presence of certain substances in its system The correlation between toxic substance and injury Prior complaints about defendant’s toxic substance Information on other lawsuits involving defendant’s toxic substance Defendant’s discharge of toxic substances Defendant’s compliance with state and federal standards

Meanwhile, the defendant will seek information to show that the pertinent facts for each plaintiff are so different, so unique, that a class should not be certified. The defendants will seek information to disprove causation, such as  Other known causes for complained of injury (diet, age, occupation, hobbies, and family history)  Plaintiff’s proof of correlation between toxic substance and injury; other toxic substances in plaintiff’s home and workplace  Scientific evidence  The identity of plaintiff’s experts, and their opinions, as well as what information these experts reviewed and their entire history of writings, testimony, and other information that might influence or contradict their testimony in the instant case

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Before trial, lawyers also may submit Requests for Admission to their opponent, seeking to confirm the truth of certain facts that, if admitted, need not be proved through testimony and other evidence during the trial.

22.4.4

Trial

A water supplier’s objective is, of course, to have the court dismiss the case outright, typically by persuading the judge through pretrial motion to disqualify plaintiffs’ experts. Often after a case is set for trial, on the basis of what they learned in discovery, the parties assess the strengths and weaknesses of their case—balanced against the potential decision by a jury—and agree on terms of a settlement before trial. Notwithstanding all the strong pretrial arguments that the defense may raise in the form of various motions and the possibility of settlement, some cases will go to trial. Plaintiffs will likely demand a jury trial. Although it is beyond the scope of this chapter to explore the intricacies of trial in detail, the key elements in the trial will be (1) the need to prove that the defendant’s actions caused the plaintiffs’ injuries and (2) the monetary amount of the plaintiffs’ injuries. Plaintiffs’ counsel will seek to accomplish this through the testimony of experts (engineers, scientists, and physicians), exhibits in the form of documents, scientific reports, possibly video presentations, and testimony from the plaintiffs themselves—or, in a class action, the testimony of representatives of the class. On the conclusion of the direct testimony of each witness for the plaintiff, defense counsel will cross-examine the witness. As to experts, defense counsel will seek to show that their scientific theories are unproven, that they have ignored the actual facts in the current case, and, if applicable, that the experts’ opinions have been discredited in other proceedings. As to the individual plaintiffs, defense counsel will elicit testimony, through cross-examination, to show that plaintiffs were exposed to numerous hazardous substances other than through drinking water (e.g., the plaintiffs will be asked whether they smoke, drink alcoholic beverages, and handle hazardous substances as part of their occupations or hobbies, and whether anyone else in their families—either in their hometowns or elsewhere—have a similar disease). The cross-examination by defense counsel will be a pivotal event in the outcome of a case. The plaintiff also may call defendants’ employees as witnesses and seek to prove that the defendant failed to meet a regulatory standard, that it knew that the presence of a particular substance could cause harm, that the defendant knew that it could do more to lower the presence of that substance in drinking water but unreasonably failed to install equipment, or operate its process in a suitable manner. Where applicable, the plaintiff will also seek to prove the defendant knew of dangerous conditions but failed to warn the consumer. This type of factor could be significant in jurisdictions that allow punitive damages. The defendant will rebut plaintiffs’ proof through its own set of experts and possibly the testimony of plant employees. At the conclusion of the testimony, the judge will instruct the jury about the issues for them to decide. While the jury

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deliberates, indeed, any time during trial before the return of the jury, the parties may enter into settlement discussions that will end the case. The jury’s verdict is not the final word. The judge may reduce a verdict as excessive, or throw out a verdict entirely as not supported by the evidence. For example, the plaintiffs in Dombrowski v. Gould Electronics, Inc. brought personal injury claims for alleged learning disabilities that their experts attributed to lead emissions from the site of a former battery lead recycling plant. The defense experts countered with testimony that the learning disabilities claimed by the plaintiffs could be explained by their parents’ low levels of education and socioeconomic status. Although the Court expressed misgivings about the reliability of such expert testimony, it weighed the evidence in its calculation of damages and awarded less money to the plaintiffs (Dombrowski 2000). Finally, regardless of the decision at the trial level, the losing side always has the option to appeal. Recognizing the potential that an appellate court might overturn a jury’s award of damages for a variety of reasons, and that an appeal might delay for many years the payment of any damages awarded by the jury, some plaintiffs will choose to settle for an amount far below the jury’s award.

22.5

CASE HISTORIES INVOLVING WATER SUPPLIERS

The following case histories were selected to highlight certain defenses of toxic tort cases that may apply to water suppliers. These include sovereign immunity, failure to give advance notice, and regulated utility exemption. The impact of Consumer Confidence Reports on litigation and the attitude of the court towards specifying water treatment are also discussed. 22.5.1

Sovereign Immunity

Sovereign immunity is a strong defense that could, where applicable, protect many government water utilities. Sovereign immunity dates back to the refusal of the King of England to be sued. Our federal government and state governments, while not royalty, claim the same immunity from litigation, except where, by legislation, they have consented to suit. Many states have extended their sovereign immunity to subdivisions with their states. Often, the protection afforded a utility by these laws depends on whether the actions giving rise to the alleged injury are determined by the court to be governmental (protected) or proprietary (not protected). Sovereign immunity is limited, but can protect nongovernment water suppliers in certain circumstances. For example, the Court of Appeals of Indiana found that Indianapolis Water Company (IWC) could not be held liable for its alleged negligence in failing to supply an adequate flow of water to combat a fire that destroyed an oil treatment facility (Metal Working 2001). The Court first ruled that IWC qualified as a governmental entity for tort claims purposes because it acted in the government’s stead and was subject to pervasive governmental regulation. The Court then held that IWC was

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entitled to governmental immunity under common law principles, reasoning that fire protection, like police protection, was an essential public service. While not a toxic tort case, a recent decision in an Ohio state court relied on the doctrine of sovereign immunity to dismiss a case against a village that failed to frequently inspect its sewer lines for grease buildup. The grease eventually clogged the sewer to such an extent that it caused backups into the plaintiffs’ basements. Under Ohio law, the court stated, a political subdivision has immunity if an employee’s act or omission was within the discretion of the employee with respect to policymaking, planning, or enforcement powers due to the duties and responsibilities of the employee. In addition, a political subdivision is immune if the alleged injury resulted from the exercise of judgment or discretion as to whether to acquire or how to use equipment supplies, materials, personnel, facilities, and other resources, assuming no malicious purpose. The court concluded that the decision to forego or have more visual inspections of sewer lines was an exercise of judgment and discretion in the use of personnel and resources. Thus, the village was immune (Wamsley 2000). 22.5.2

Failure to Give Municipality Mandatory Advance Notice

In many states, state and local statutes require a plaintiff to file a notice of claim in a tort action within 90 days (or some other specified time) after the claim arises as a condition precedent to commencement of action against the municipality or public corporation. In Markweise v. Peck, numerous plaintiffs were barred from the proceeding with their complaints because they failed to provide the municipality with advance notice of their claim (Markweise 1996). The court held that in a class action notice given by the representative plaintiffs and the known members of the plaintiff’s class to the city did not satisfy the requirement of presentment to the city of the claims for the unnamed members of the class. The court also held that the exception to presentment, which is if the city has ‘‘actual notice’’ of the event giving rise to the claims, did not apply. The issue of actual notice is factually specific. The fact that the Markweise court did not find actual notice on these facts does not mean that another court may not find actual notice on similar and related facts. The court also noted in Markweise that the class action procedure did not trump the requirement of notice to the city under the state statute. This means that only the plaintiffs in a class action who have complied with the notice requirement may proceed against the city while those that are unaware of the requirement may be foreclosed in participating in the class action due to failure to give notice. 22.5.3

Federal, State, and PUC Preemption

In Mattoon v. City of Pittsfield, Massachusetts residents who allegedly contracted giardiasis (or ‘‘beaver fever’’) from drinking contaminated water brought suit against the city and various contractors and consultants for alleged violations of federal and state laws (Mattoon 1992). The plaintiffs were 68 residents who filed a ‘‘citizens’ action’’ seeking equitable relief and civil penalties under the SDWA. They also

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sought compensatory damages under federal common law nuisance claims as well as other claims. The First Circuit held that the SDWA preempted federal common law nuisance and civil rights claims and that residents failed to demonstrate an ongoing violation that was prerequisite to recovery under SDWA. The preemption decision was based on the fact that Congress in the enactment of the SDWA had occupied the field of public drinking water regulation through the establishment of a comprehensive regulatory program supervised by an expert administrative agency. A court should be reluctant to imply a legal duty between water suppliers and customers where the statute does not establish it in the form of a private right of action. In City of Evansville v. Kentucky Liquid Recycling, Inc., the court held that there was no private right of action contained in SDWA, Section 300, and therefore rejected a negligence per se claim. While the negligence per se claim failed, the plaintiffs were allowed to proceed on nuisance claims (City of Evansville 1979). In Hartwell Corp. v. Superior Court of Ventura County, the courts in California addressed a fundamental question: Is compliance with drinking water standards a full defense? Multiple actions were brought against water utilities and others arising from alleged aquifer pollution. The intermediate court held that Public Utilities Commission (PUC) statutory authority over water quality and its exercise of jurisdiction in addressing water quality issues precluded private actions against the regulated utilities, but did not bar the actions against the defendants not regulated by the PUC (Hartwell 1999). On appeal, the California Supreme Court declined municipal water suppliers’ arguments to extend the protection from litigation to them, and whittled away at the relief from litigation for PUC-regulated private water utilities. The Supreme Court held that the PUC’s statutory authority over water quality and its exercise of jurisdiction in addressing water quality issues preclude private actions against regulated utilities in compliance with regulatory standards, but does not bar lawsuits regarding noncompliance (Hartwell 2002). In general, many courts are reluctant to impose additional duties on defendants who have complied with applicable state and federal statutory standards. While there is no federal court decision that holds that compliance with SDWA standards is a complete defense to toxic tort claims, there is strong support for such a ruling based on a similar cases arising under the Clean Water Act (Milwaukee 1981, International Paper 1987) and the Clean Air Act (New England Legal Foundation 1981). Several federal circuit courts, along with many state courts, have held that failure-to-warn claims are preempted by FIFRA. In cases concerning these acts, plaintiffs sought to recover under common law theories of tort or nuisance against defendants that had complied with the applicable federal standard. The reasoning of each court in these cases included a common thread—it was not going to upset the balance set by the legislature who intended to set the standard of care by regulating the activity under scrutiny. 22.5.4

Consumer Confidence Reports and Litigation

While Consumer Confidence Reports may spur some litigation, they can provide utilities with a strong defense. Plaintiffs often contend that one of the reasons a

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defendant was negligent is that it failed to warn the plaintiffs of the presence of the contaminant and its potential for harm. This is a major thrust of a class action filed in a state court in Louisiana. In Oldham v. Louisiana, the plaintiffs, workers at an industrial plant, claimed that they were allegedly exposed to, and suffered injuries from, drinking water contaminated with arsenic (Oldham 2001). The defendant was the Louisiana Department of Health and Hospitals. The complaint alleged that the DHH detected elevated arsenic levels in wells at the plant in 1998, but did not inform the workers until April 2001. As a result of the new requirements to provide Consumer Confidence Reports, water suppliers who carefully identify all contaminants, and explain their potential impact should be able to prevail against claims for failure to warn. 22.5.5

Court Action Regarding Treatment of Water

A court will not allow a consumer to dictate how water should be treated. In AlliedSignal, Inc. v. City of Phoenix, a landowner sued the city for negligence, breach of implied warranty of merchantability, breach of implied warranty of fitness for a particular purpose, and strict liability for failure to warn, seeking money damages for damage to its water sprinkler systems allegedly caused by excessive amounts of bacteria in water provided by the city. The landowner sought money damages and equitable relief for the damage to its water sprinkler systems. The landowner determined that the corrosion inducing bacteria in the water supplied by the city was causing the corrosion. The court held that allegations in the landowner’s complaint supported a claim for negligence. But the landowner was not entitled to writ of mandamus compelling the city to pretreat its water to render it free of corrosion-inducing bacteria. Water suppliers can also be plaintiffs in toxic tort cases. In Iberville Parish Waterworks Dist. No. 3 v. Novartis Crop Protection, Inc., the public water systems sued a herbicide manufacturer to recover water treatment costs (Iberville 1999). The court held that the systems had suffered no injury in fact and thus presented no justifiable claims. The court stated that there was no injury because the systems were not in violation of water quality standards for herbicide, future violations were speculative, and incurred system upgrade costs were for the general purpose of having better-tasting and clearer drinking water. Even if public water systems were in violation of USEPA regulations regarding herbicide level, the systems’ claims against the herbicide manufacturer were not ripe because the systems had not yet violated statutory limits. This was a class action on behalf of the plaintiff, other citizens, and community water systems. Here the cause in fact or proximate cause element was not satisfied by the plaintiffs.

22.6

FUTURE OUTLOOK FOR TORT LITIGATION

In many respects, the first wave of what may become a flood of toxic tort litigation against water suppliers has only begun. In the absence of a definitive statement by

REFERENCES

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Congress that compliance with government standards is a complete defense against toxic tort suits, hundreds of courts, both state and federal, in 50 states and the District of Columbia, may issue a wide range of conflicting decisions. A trend should develop that compliance is a defense. Congressional action is needed to make clear that compliance is a complete defense. ACKNOWLEDGMENTS Halley Sexter, who commenced a major portion of this chapter while she was my associate, deserves special credit. The explanation about class actions, and the case law discussion on causation, was adapted from an article by my colleagues James D. Pagliaro and Glen R. Stuart, both of whom have significant experience in the defense of toxic tort and environmental claims. REFERENCES AlliedSignal. 1999. AlliedSignal, Inc. v. City of Phoenix, 182 F.3d 692 [9th Cir.]. Amchem. 1997. Amchem Products v. Windsor, 521 U.S. 591. Boston, G. W. and M. S. Madden. 1994. Law of Environmental and Toxic Torts. St. Paul, MN: West Publishing Company. Castellow. 2000. Castellow v. Chevron USA, 97 F. Supp. 2d 780 (S.D. Tex.). CERCLA. 1986. Comprehensive Environmental Response, Compensation, and Liability Act, 42 USC Sec. 9658. City of Evansville. 1979. City of Evansville v. Kentucky Liquid Recycling, Inc., 604 F.2d 1008 (7th Cir.). Daubert. 1993. Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579. Dombrowski. 2000. Dombrowski v. Gould Electronics, Inc. 85 F. Supp. 2d 456 (M.D. Pa.). Fed. R. Civ. Proc. 1999. Federal Rules of Civil Procedure. Washington, DC: U.S. Government Printing Office. Frye. 1923. Frye v. United States, 293 F. 1013 (D.C. Circuit). Gall et al. 1989. Gall v. Allegheny County Health Dept., 555 A.2d 786 (Pa. 1989); Miller v. McKeesport Municipal Water Authority, 555 A.2d 790 (Pa. 1989); McKeesport Municipal Water Authority v. McCloskey, 690 A.2d 766 (Pa. Commonwealth Court 1997). Garner, B. A. 1990. Black’s Law Dictionary, 6th ed. St. Paul, MN: West Group. Geier. 2001. Geier v. American Honda Motor Co., 529 U.S. 861. General Electric. 1997. General Electric Co. v. Joiner, 522 U.S. 136. Haig, R. L. 1998. Business and Commercial Litigation in Federal Courts Sec. 15.3, St. Paul, MN: West Group & ABA. Hartwell. 1999, 2002. Hartwell Corp. v. Superior Court, C 74 Cal.App. 4th 837 (1999), affirmed in part and reversed in part, 27 Cal. 4th 837 (2002). Iberville. 1999. Iberville Parish Waterworks Dist. No. 3 v. Novartis Crop Protection, Inc., 45 F. Supp. 2d 934 (S.D. Ala. 1999). International Paper. 1987. International Paper v. Oullette, 479 U.S. 481.

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Kumho. 1999. Kumho Tire Co. v. Carmichael, 526 U.S. 137. Lofgren. 1998. Lofgren v. Motorola. No. CV 93-05521, 1998 WL 299925, slip opinion at* 17 (Ariz. Superior Ct. June 1). Markweise. 1996. Markweise v. Peck Foods. 556 N.W.2d 326, 333 (Wisc. Ct. App.). Mattoon. 1992. Mattoon v. City of Pittsfield. 980 F.2d 1 (1st Cir.). Merrell. 1997. Merrell Dow Pharmaceuticals, Inc. v. Havner, 953 S.W.2d 706 (Tex. 1997), Certiorori denied, Havner v. Merrell Dow Pharmaceuticals, Inc., 523 U.S. 1119 (1998). Metal Working. 2001. Metal Working Lubricants Company et al. v. Indianapolis Water Company. 746 N.E. 2d 352 (Ind.). Millett. 2000. Millett v. Atlantic Richfield Co., 760 A.2d 250. Milwaukee. 1981. Milwaukee v. Illinois, 451 U.S. 304. Nelson. 2001. Nelson v. Tennessee Gas Pipeline Co., 243 F.3d 244 (6th Cir.). New England Legal Foundation. 1981. New England Legal Foundation v. Costle, 666 F.2d 30 (2d Cir.). Oldham. 2001. Oldham v. Louisiana, La. Dist. Ct., 18th Jud. Dist., No. 55,160, complaint filed April 10. Pagliaro, J. D., G. R. Stuart, and G. R. Gilgore. 2000. Recent trends in environmental tort litigation. In Environmental Deskbook 2000. Washington, DC: Morgan, Lewis & Bockius LLP. Reilly. 1997. Reilly v. Gould, Inc., 965 F. Supp. 588, 606 (M.D. Pa.). Reynolds. 1999. R. J. Reynolds Tobacco Co. v. Engle, 784 So. 2d 1124 (Fla. Ct. App., 3d Dist.). Rutigliano. 1996. Rutigliano v. Valley Business Forms, 929 F. Supp. 779 (D.N.J.). Shaw. 1993. Shaw v. Dow Brands Inc., 994 F.2d 364 (7th Cir.). Thomas. 1994. Thomas v. FAG Bearings Corp., 846 F. Supp. 1400, 1404 (W.D. Mo.). TMI. 1996. In re TMI Litig., 927 F. Supp. 834, 864 (M.D. Pa.). TMI. 1999. In re TMI Litig., 193 F.3d 613 (3rd Cir.). Wamsley. 2000. Wamsley v. West Jefferson, 743 N.E. 2d 442 (Ohio). Wright. 1996. Wright v. Willamette Industries, Inc., 91 F.3d 1105 (8th Cir.).

23 INTELLECTUAL PROPERTY LAWS AND WATER TECHNOLOGY LINDA E. B. HANSEN, Esq. Patterson, Thuente, Skaar and Christensen, L.L.C., Milwaukee, Wisconsin

23.1

INTRODUCTION

Patents cover a wide variety of products and processes used in water treatment. Methods for removing contaminants, equipment used to analyze water quality, and testing methods are the subject of many patents. As with all industries, recovering the cost of research and development is a concern of those in the field of water technology. One way to recapture the costs of, and potentially profit from, the money spent on technological improvement is to obtain legal protection by way of a patent. A patent is a legal protection for ideas, or intellectual property. In order to take advantage of intellectual property laws to protect an idea, it is important to know something about what can and cannot be protected. This chapter is a cursory overview of a complex subject. It is not intended as legal advice, but rather, as a primer to understanding the basic principles of U.S. patent laws.

23.2

PROPERTY, COPYRIGHTS, TRADEMARKS, AND PATENTS

Property is something having recognized value, and may be owned by an individual or a company. Property is either real or personal. Real property is immovable, such Drinking Water Regulation and Health, Edited by Frederick W. Pontius. ISBN 0-471-41554-5 # 2003 John Wiley & Sons, Inc.

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as land, while personal property is movable, and includes intangible concepts such as ideas, or intellectual property. The government grants certain property rights to people or companies who own intellectual property. It is an asset for its owner, and can be used to shelter other assets of a company. The term ‘‘intellectual property’’ encompasses patents, trademarks, trade secrets, and copyrights. Intellectual property laws include the patent, trademark, trade secret, copyright, and unfair competition laws that protect intellectual property. These laws provide protection for the ownership of ideas. Capitalism is founded on the principle that increased competition will drive prices lower. Intellectual property laws carve out specific exceptions to laws designed to prohibit monopolies. The philosophy behind intellectual property laws is that if people can profit from their ideas, they will have incentive to come up with new ideas. As patent laws require patent owners to disclose those ideas to the public in order to get the protection offered by this limited monopoly, others can make improvements in the field, and our knowledge will grow and technology will move forward. Copyrights were created to reward creative work in literature and the arts. Copyrights protect the maker’s original creative expression included in the tangible format of an item. They confer the right to reproduce the copyrighted work and are secured automatically when the work is created. Articles and presentations are subject to copyright laws. The creator of the work covered by the copyright generally owns the copyright. Copyrights in existence on or after January 1, 1978, generally expire 70 years after the death of the author or creator. (Copyright Act of 1976, x302(a) 17U.S.C.). Trademarks and patents protect industrial property. Trademarks protect distinctive signs, such as the combination of words, symbols, and colors that are part of a logo. Trademarks address and protect the item’s ability to identify its origin. Trademark protection is intended to prevent consumers from confusing one manufacturer with another. Service marks distinguish different service providers. Trademarks and service marks are continuous, so long as they continue to be distinctive and continue to be used. Patents protect inventions and ornamental designs. Most patents last 20 years from the filing date of the patent. Patent protection aims to encourage investment in research and development related to new technology. It can also encourage joint ventures and product licensing.

23.3

PATENT LAWS

The United States rewards the first to invent as long as that person was diligent in moving from the conception of the idea to the reduction to practice. In other words, people are rewarded for their continuous efforts to move from the idea to the invention. Some other countries tie the grant of patents to the first to file a patent application. There are potential problems with both systems. It can be difficult to

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determine the first inventor, while the first to file an application is easily identified. Conversely, the rush to be the first to file can result in a less developed invention being disclosed in the patent application. The U.S. system also rewards those who fully disclose their invention, and fully disclose the best mode of making their invention in the patent application. This enables others to make improvements on patented technology, and encourages continued technological improvement. To take advantage of the patent laws to protect your idea, it is important to know what is and what is not patentable, and the process involved. General concepts regarding U.S. patent laws are reviewed here. Readers deciding to seek patent protection for an idea will be best served by contacting an attorney who specializes in intellectual property. 23.3.1

Historical Overview of Patent Protection

In the field of intellectual property, a patent is generally defined as ‘‘a grant made by the government to an inventor, conveying and securing him the exclusive right to make use or sell his invention for a term of years’’ (Garner 1968). Historically, governments granted patents to reward inventors for their inventiveness and to encourage continued production of socially beneficial inventions. Patents were not specifically intended to protect the inventor’s interests in the invention. For example, in 1474, the Venetian Senate enacted the first general patent law to honor inventors and ‘‘prompt a desire in others, who ‘would then apply their genius and would build devices of great utility to the commonwealth.’’’ In the sixteenth century, the English government adopted the Venetian patent concept. It was abused when English monarchs granted monopolies to their relatives, causing public outcry for Parliament to enact the Statute against Monopolies in 1673. That statute was the first to establish the principle that only the ‘‘first and true’’ inventor has the right to be granted a patent. Patent monopolies, unlike other monopolies, were believed to serve as a reward to persons for exercising original thought for the benefit of society. Laws enacted to abolish monopolies, such as Britain’s Statute against Monopolies, specifically made exceptions for the award of patent monopolies. During the time of the French and American Revolutions, the rationale behind granting patents shifted from rewarding inventiveness, to conferring a right on the inventor to exclude others from making, using, or selling the patented invention. This philosophical shift was incorporated into the primary patent granting authority of the United States, Article I, Section 8 of the U.S. Constitution. In today’s international business climate, it is important to consider international laws when determining the value of a patent. While the law varies from country to country, more than 90% of all countries are included in the World Trade Organization (WTO). The WTO members entered into an agreement known as TRIPS, the Agreement on Trade-Related Aspects of Intellectual Property Rights. The TRIPS agreement, which took effect in 1995, establishes the minimum standards of intellectual property protection and procedures for enforcing this protection and settling disputes among WTO member countries.

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23.3.2

The United States Patent System

Under Article I, Section 8 of the United States Constitution, ‘‘The Congress shall have the power . . . to promote the progress of science and useful arts, by securing for limited times to authors and inventors the exclusive right to their respective writings and discoveries.’’ This provision of the Constitution permits the government to grant an inventor a time-limited term to an exclusive right to make, use, sell, or offer to sell the claimed invention in exchange for a complete public disclosure of that invention. At the end of the time-limited term, the claimed invention becomes part of the public domain. Once an invention is part of the public domain, it may be practiced by anyone, without infringing the patent. Congress established the United States Patent Office [now known as the United States Patent and Trademark Office (PTO)] in 1836. Its primary purpose is to examine patent applications and ensure that patent rights are not granted on information already within the public domain. Patent applications filed with the PTO are examined in accordance with Title 35 of the United States Code (35 USC), Title 37 of the Code of Federal Regulations (37 CFR), and agency guidelines outlined in the Manual of Patent Examining Procedure (PTO 1996). Under the current patent system, the time-limited term for an issued patent is 20 years from the date of filing the patent application (35 USC Sec.154, 1996). A patent application must set forth what the inventor claims as the invention. A patent examiner reviews those claims and determines whether they assert a new and useful invention under the current patent law or are already disclosed by a previous invention. Following an examination, the patent application is either rejected or allowed. If the application is allowed, the scope of protection granted under the patent is defined by the inventor’s ‘‘claims’’ issued in the patent document. 23.3.3

Basic Requirements for Patentability

Under the U.S. patent system, an inventor must show that the invention satisfies basic requirements for patentability as defined under 35 USC Sec.101. The claimed invention must be:





Patentable subject matter; Novel; Nonobvious to one skilled in the art; and Fully disclosed to the PTO so as to enable one skilled in the art to replicate the invention.

Each of these elements must be satisfied for all types of inventions. A patent will not be issued if the invention fails to meet any single element. Patentable Subject Matter An inventor may obtain a patent only if the subject matter of his claimed invention is patentable as defined under 35 USC Sec.101, which states: ‘‘[W]hoever invents or discovers any new and useful process, machine,

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manufacture, or combination of matter, or any new and useful improvement thereof, may obtain a patent therefore, subject to the conditions and requirements of this title.’’ An invention is considered ‘‘new’’ if it is an invention ‘‘made by a human.’’ It cannot be a mere discovery or ‘‘product of nature’’ such as a newly identified plant variety. The invention must be ‘‘created by a human.’’ While living organisms created through crossbreeding are not patentable, nonnaturally occurring, nonhuman multicellular organisms are (Animal Legal Defense Fund 1991). Genetically altered organisms therefore may be patentable. An invention must also have some ‘‘usefulness’’ or ‘‘utility’’ to qualify as patentable subject matter. For example, an inventor could develop new compound X, but it would not qualify as patentable subject matter unless the inventor also shows a use or application for compound X. The term ‘‘useful’’ has been interpreted by courts to mean ‘‘operable’’—that is, capable of being used to meet some stated objective. It need not be the best or only way of meeting that objective (Raytheon 1984). In general, the PTO and the courts have interpreted this statute broadly to presume that a claimed invention falls within the definition of patentable subject matter unless it falls within a class of inventions that were previously excluded from the definition by a specific agency or court decision. Examples of inventions specifically excluded are printed matter (computer programs embodied in a tangible medium, such as floppy diskettes, are not considered printed matter) (In re Beauregard 1995), naturally occurring articles, and scientific principles (PTO 1996). In each of these cases, the PTO and=or the courts determined that the subject matter of the claimed invention was found to be either not ‘‘new’’ in terms of inventiveness or not ‘‘useful’’ as required under 35 USC Sec.101. An invention must be both ‘‘new’’ and ‘‘useful’’ to qualify as patentable subject matter. In the United States, patentable subject matter is defined solely in technical terms. The PTO examines the subject matter of an invention without regard to moral or ethical concerns. Matters of public policy may generate legislation that restricts the scope of what society considers permissible subject matter, but it does not change the technical PTO standard for determining whether an invention is ‘‘new.’’ In other words, Congress may restrict what types of subject matter qualify as potentially patentable, but the PTO ultimately decides whether a specific invention, arising out of a permitted type of subject matter, satisfies the technical requirements for patentability specified under 35 USC Sec.101. Congress may limit the breadth of patentable subject matter through legislation. For example, 42 USC Sec.2181(a) of the Atomic Energy Act states that ‘‘No patent shall hereafter be granted for any invention or discovery which is useful solely in the utilization of special nuclear material or atomic energy in an atomic weapon.’’ Legislative limitations are usually based on public policy concerns such as the potential problems created by a public disclosure of a method of making an atomic weapon. Novelty A patent may only be granted if a claimed invention is novel. ‘‘Novelty,’’ as defined by 35 USC Sec.102, requires that the applicant for a patent be an actual

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inventor of the claimed invention, and that the invention must not have been (1) known or used by others in the United States before the invention by the applicant for patent; (2) patented or described in a printed publication anywhere in the world before the invention by the applicant, or more than a year before the filing date of the application for patent; or (3) invented by another who has not abandoned or concealed the invention; or (4) prior to the application for patent, the invention was described in a patent application filed by another where the other’s patent application later issues into a U.S. patent. These requirements set a time deadline, or statute of limitations, on filing a patent application. They require an inventor to file the patent application within one year of making, selling, or publicly disclosing the claimed invention. If the inventor fails to file the application in that period of time, the invention will be considered within the public domain, and a patent will not issue. These requirements also prevent an individual from claiming a right to something already in the public domain. If the invention was known by others, even if that knowledge was limited to only a few people, or the subject of a publication with limited circulation, it is deemed to be in the public domain, and no patent will issue. A confidential memorandum describing the invention is not likely to be a publication within the rule cited above, but an article in a technical journal or presented at a conference would be considered a publication. The test for whether a written description of an invention is a publication is whether the writing is of public character, intended for general use, and within reach of the public (Chisum 1996). A grant application for funding with a governmental agency may be such a publication if it is indexed and available (E.I. du Pont de Nemours 1990). Nonobviousness Even though an invention qualifies as patentable subject matter and is novel, a patent will not be granted if the claimed invention is nothing more than a trivial or ‘‘obvious’’ modification of the current state of the art of the claimed subject matter. Under 35 USC Sec.103, a patent may not be obtained if ‘‘the differences between the subject matter as a whole and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made, to a person having ordinary skill in the art to which the subject matter pertains’’ (35 USC Sec.103). For example, if water contaminant A is known to be removed by chemical B, and it is also commonly known that chemical C is often used as a functional equivalent to chemical B, it would be considered obvious to remove contaminant Awith chemical C. Therefore, a patent application claiming the removal of contaminant A with chemical C would be rejected as obvious to anyone skilled in the art of water chemistry. When determining if an invention is obvious, the courts and the PTO must make ‘‘several basic inquiries.’’ Those inquiries, which set the background for the determination of obviousness or nonobviousness, are (Graham 1966)
The scope and content of the prior art
Differences between the prior art and the claims at issue
The level of ordinary skill in the pertinent art

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Secondary considerations can also be used to show nonobviousness. If an invention solves a problem, the solution to which had been sought by many over a period of time, it is likely that the invention is not obvious. In addition, the commercial success of an invention is a secondary indicator that the invention is not obvious. Nonobviousness and novelty are distinct tests, but both require an analysis of the prior art, that is, what others have done in the field. A novelty determination is centered on whether others have already invented the claimed invention. A nonobviousness determination is centered on whether, on the basis of what others have done, the claimed invention is obvious. Disclosure of the Best Mode An inventor must provide a full and complete disclosure of the invention in exchange for a right to prevent others from making, using, or selling the invention within the United States for a term of 20 years from the date of filing the patent application. Under 35 USC Sec.112, the disclosure must provide the ‘‘best mode’’ at time of filing of the invention that will enable someone skilled in the art pertaining to the patent application to replicate the claimed invention. If a patent is issued on an invention, and it is later discovered that the best mode of invention was not disclosed by the inventor as required, the patent may be invalidated for failing to comply with the requirements of Sec. 112. Diligence and Documentation The United States rewards the first to invent so long as that person was diligent in moving from the conception of the idea to the reduction to practice. In other words, people are rewarded for their continuous efforts to move from the idea to the invention. The inventor must take active steps to reduce the idea to a useful functioning invention. The development of an idea into a useful invention is called ‘‘reduction’’ to practice. The effort taken to reduce an idea to practice is known as ‘‘diligence.’’ Active diligence comports with the principles of patent law, which provides a reward and encouragement for disclosure of a workable invention to the public as early as possible. Assuming ongoing diligence on the part of the inventor, it is normally the first inventor to conceive of an idea rather than first to reduce to practice who establishes the right to a patent. An inventor who conceives of an idea but does not diligently work at reducing the idea to practice may lose patent rights to a second inventor who conceived the idea second and actively reduced the invention to practice first. The inventor can accomplish reduction to practice by (1) actually reducing an idea to practice or (2) constructively reducing an idea to practice by filing a patent application. Actual reduction to practice varies according to the type of invention but basically requires an inventor to create a physical embodiment of the invention including all its unique characteristics, which is suitable for its intended purpose. For example, to demonstrate actual reduction to practice of a chemical composition, it is sufficient to prove that the inventor actually prepared the composition and knew that it would work for its stated use. The amount of testing required to demonstrate the operability of the invention varies greatly from case to case. Constructive reduction to practice is accomplished by filing a patent application. This provides a date of reduction of practice no later than the filing date of the

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application if the patent is granted. The patent statute does not contain any express requirement that an invention must be ‘‘actually’’ reduced to practice before it can be patented. There is case law dating back to 1888 that upheld a patent granted to Alexander Graham Bell even though he filed his patent application before constructing a working telephone. The court’s decision states that (The Telephone Cases 1888) [T]he law does not require that a discoverer or inventor, in order to get a patent for a process, must have succeeded in bringing his art to the highest degree of perfection. It is enough if he describes his methods with sufficient clearness and precision to enable those skilled in the matter to understand what the process is, and if he points out some practicable way of putting it into operation.

The patent system also rewards those who disclose the best mode of making their invention in the patent application. This enables others to make improvements on things that are patented. It is not enough for an inventor to simply be the first to conceive an idea in order to be entitled to a limited monopoly in an invention under U.S. patent law. In order to ensure that an inventor reaps the greatest benefit from an idea, it is important to get patent counsel involved early in the development stage of an invention. The goal is to get the greatest disclosure of the invention in front of the patent and trademark office as early as possible. Patent counsel can also address other concerns of the invention, including loss of foreign and domestic patent rights through improper disclosure of the invention to the public. Documentation of the inventor’s efforts is as important as diligent reduction to practice. The date of the invention is presumed to be the date of the filing of the patent application. An inventor can demonstrate an earlier date of invention, but bears the burden of proving the earlier date by showing either an earlier reduction to practice or an earlier conception and diligence to reduction to practice. This heavy burden on the inventor is complicated by the fact that courts regard oral testimony of inventors with skepticism. Many courts have found that uncorroborated oral testimony of an inventor does not meet the heavy burden of proof to demonstrate a date of invention prior to the filing date of an application. Courts have relied on written evidence, such as the inventor’s contemporaneous notebooks, and testimony by witnesses other than the inventor as adequate corroboration. It is important to consider the entire invention when attempting to document conception, diligence, and reduction to practice. An inventor should be able to demonstrate the greatest grasp of her or his invention, including all of its unique features individually, and as a synthesized invention, at the earliest date possible. Actual Inventor According to 35 USC Sec.102(f), no one may obtain a patent if he=she did not invent the subject matter he=she seeks to patent. There may be joint inventors when the invention is the product of collaborative endeavors of two or more persons working toward the same end and producing an invention by their aggregate efforts (Monsanto Co. 1967). All inventors are to be named in a patent,

23.4 OBTAINING A PATENT

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and no one is to be named as an inventor who is not an actual inventor. If a mistake in naming the inventor(s) is made without intent to deceive, it may be corrected by the Commissioner of the PTO (35 USC Sec.256). An intentional misrepresentation of the identity of the actual inventor is handled quite differently, and may cause any patent granted as a result of the deceptive application to be invalidated. In some instances, an individual is hired to invent something to solve a problem encountered by their employer. As a result of the employment relationship, the patent may belong to the employer. In such a circumstance, the employee who invented the solution to the problem must apply for the patent. It is then generally assigned to the employer. The employer, who may have contractual ownership of the invention, or anyone else to whom patent rights have been assigned, cannot apply for the patent unless the inventor is unavailable, or is unwilling to cooperate with contractual obligations (35 USC Secs. 117, 118). On Sale=Public Use Bar 35 USC Sec.102(b) indicates, in part, that even if a patent application meets all the other requirements for a patent, the right to a patent can be lost if the invention is in public use or on sale in this country more than one year prior to the date of the patent application in the United States. The concept of both of these requirements is that once an invention is known to the public for more than a year, it is part of the public domain, and should not be removed from public use by the grant of a patent. An inventor has the right to experiment with the invention for a period of time to determine whether it does what it was intended to do. While this experimentation is going on, efforts should be taken to ensure that the experimental use is not public. If it is not possible to experiment without making the invention publicly known, it is important to document the experimental nature of the public use. A recording of the inventor’s control and monitoring of the experimental use can be used to indicate that the use would not invalidate the patent. Any offer of sale of an invention can invalidate the patent if it occurs more than one year prior to the application for the patent. It is not necessary that a sale actually be made. A demonstration or description of the invention coupled with an inquiry into potential orders can be an invalidating offer to sell if the inventor would have sold the invention to the person to whom it was being shown.

23.4

OBTAINING A PATENT

The first step in obtaining a patent (Fig. 23.1) is conception of the original idea. Any person who intends to patent an idea should first determine if the idea has already been patented. A patent search can indicate the patents already issued in the field of the invention. The PTO maintains a web site listing every patent issued by that office. It is located at www.uspto.gov. An initial search of the PTO Website may show how crowded the field of the invention is, and whether there are other patents that may cover the invention. The similarity of other patents to the invention under consideration could also indicate the potential commercial viability of the invention.

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Figure 23.1 General process for obtaining a patent.

During development of an invention, documentation of diligent progress is necessary. A notebook should be kept showing the steps taken and indicating when they were taken. This will document both diligence and actual inventorship. It will also indicate the date of the conception of the idea should another inventor attempt to patent the same idea. In the United States, only the first to invent may obtain a patent. An application for the patent must be filed within 1 year of when the invention is first sold, made, or publicly disclosed. The cost of obtaining a patent might be considered if the potential for commercial viability is low, or if there is no strategic need to protect that area of technology. Some companies that do not intend to make commercial use of patents obtain them for their potential future use or for licensing. In addition to the cost of obtaining a patent, there are renewal fees required to keep it in force. A patent expires 20 years after the application is filed.

23.5

PATENT INFRINGEMENT

Once a patent is issued, the patentholder has the right to prevent all others from practicing the patented invention. The patentholder may enforce this right through the legal system (Fig. 23.2). Patent lawsuits are brought in federal courts, where they may be decided in a jury trial. Before a lawsuit is brought, attempts to resolve the conflict are often made. When a patentholder learns that another is potentially practicing a patented invention, a ‘‘cease and desist’’ letter is commonly sent to the potential infringer advising them of the existence of the patent, and demanding that they stop practicing the patented invention. The letter may request compensation for lost profits or a royalty for infringing sales. It may suggest a licensing arrangement. The cease-and-

23.5 PATENT INFRINGEMENT

565

Figure 23.2 Infringement legal process.

desist letter may threaten legal action, but doing so may allow the potential infringer to file a declaratory judgment action in a court convenient to the potential infringer, rather than a court convenient to the patentholder. To determine whether a patent is infringed, one must first look at the claims in the patent. The claims set forth the exact nature of the patented invention. Determining the scope of the claims, or claim construction, not only focuses on the printed patent but also considers comments made by the patent applicant during prosecution of the patent application. Amendments made to the claims during the prosecution of the patent may indicate whether certain interpretations of the claims were intended to be covered by the claims. The specifications in the patent may also be evidence of what was intended by the claims. Although experts in the field may also be called to interpret the claims, this can be an expensive option. It is not unusual for a patentholder to request that a court grant a temporary restraining order (TRO) when filing an infringement lawsuit. A TRO can prohibit further infringement and can be a strong incentive to resolve the conflict. Conversely, if a patentholder obtains a TRO, and is unable to prove infringement, costs can be assessed against the patentholder and paid to the party against whom the TRO was issued. Money damages are only available for infringement that occurred during the 6 years preceding the filing of the lawsuit (35 USC Sec.286). Money damages may include items such as lost profits, lost royalties, compensation for lost market position, and compensation for damage to the patent holder’s business reputation. To receive lost profits, a patent owner must prove a demand for the patented product, the absence of acceptable noninfringing substitutes, the ability of the patent owner to manufacture and market to exploit the demand, and the amount of the profit that would have been made absent the infringement (Panduit Corp. 1983). Patents are presumed valid, (35 USC Sec. 282) but often, those accused of infringing a patent will make an effort to find the patent invalid. It is the burden of the party alleging invalidity to prove their claims.

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23.6

INTELLECTUAL PROPERTY LAWS AND WATER TECHNOLOGY

FUTURE OUTLOOK IN INTELLECTUAL PROPERTY LAW

An inventor of a new and useful process, machine, manufacture, or composition of matter, or any improvement on such, may be able to obtain a patent on the invention. If the invention is novel and not obvious, and if other statutory requirements are met, a patent may be issued. The grant of a patent allows the inventor to use the patent as a business asset. Patents prohibit others from practicing the patented invention. In cases of infringement, the patent is presumed valid, and the legal system provides a forum for disputes. New drinking water treatment technologies and novel applications of existing technologies may be patentable. Hence, water suppliers can expect to face patent issues and the potential for patent infringement as new and novel technologies are considered and installed.

ACKNOWLEDGMENTS The author would like to thank Thaddeus Stankowski for his invaluable advice and assistance in the drafting of this chapter.

REFERENCES Animal Legal Defense Fund v. Quigg. 1991. 932 F.2d 920, 18 USPQ2d 1677. Chisum, D. S. 1996. Patents Sec. 3.04(2), citing W. Robinson, The Law of Patents for Useful Inventions Secs. 325–327 (1890). E.I. du Pont de Nemours & Co. v. Cetus Corp., 1990. 19 USPQ2d 1174 (N.D. Cal 1990). Garner, B. A., ed. 1968. Black’s Law Dictionary. St. Paul, MN: West Publishing Company. Graham v. John Deere. 1966. 383 U.S. 1, 17, 148 USPQ 459. In re Beauregard. 1995. 53 F.3d 1583, 1584, 35 USPQ2d 1383, 1384. Monsanto Co. v. Kamp. 1967. 299 F.Supp. 818, 154 USPQ 259, 35 USC Sec. 116. Panduit Corp. v. Stahlin Bros. Fibre Works, Inc. 1983. 575 F.2d 1152, 220 USPQ 490 (Fed. Circuit 1983). PTO. 1996. Manual of Patent Examining Procedure (MPEP). Washington, DC: U.S. Government Printing Office. Raytheon Co. v. Roper Corp. 1983. 724 F.2d 951, 958, 220 USPQ 592, 598 (Fed. Circuit 1983), cert. denied 469 U.S. 835 1984. The Telephone Cases. 1888. 126 U.S. 1, 535–536.

24 WATER SYSTEM SECURITY FREDERICK W. PONTIUS, P.E. Pontius Water Consultants, Inc., Lakewood, Colorado

24.1

INTRODUCTION

The terrorist attacks on the World Trade Center and the Pentagon on September 11, 2001, initiated a significant psychosocial change in Americans’ sense of safety and protection from externally imposed harm. Subsequent infections and fatalities caused by anthrax-tainted letters sent through the U.S. Postal Service (Jernigan et al. 2001) reinforced a sense of fear and uncertainty at each U.S. doorstep. Since then, Congress and the federal government in general, including the U.S. Environmental Protection Agency (USEPA), have been functioning as a war government (Mehan 2001). Although traditional environmental concerns still receive governmental attention, protection of drinking water supplies is a top priority. As long as terrorist threats and war-related activities continue, water utility customers may have a nagging concerns about the safety of their drinking water. Regulatory compliance planning must include emergency planning so that should a natural disaster or terrorism incident occur, the utility will be ready to respond quickly and in a manner that will prevent adverse health consequences and minimize noncompliance (Pontius 2002). In the months following September 11, 2001, growing attention was given to ensuring the safety of United States drinking water systems (Meeks 2002, Shannon 2002). The Public Health Security and Bioterrorism Prevention and Response Act of 2002 (P.L. 107-188) was enacted into law June 12, 2002, adding several important new sections to the Safe Drinking Water Act (SDWA). USEPA is tasked with ensuring that the 8000 water systems serving 3300 or more people conduct vulnerDrinking Water Regulation and Health, Edited by Frederick W. Pontius. ISBN 0-471-41554-5 # 2003 John Wiley & Sons, Inc.

567

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WATER SYSTEM SECURITY

ability assessments. The purpose of this chapter is to introduce the importance of water system security, and review the SDWA provisions addressing security. Two conflicting points of view exist within the water industry regarding dissemination of information regarding drinking water system vulnerability. The first view advocates that any information on water system vulnerabilities and potential contaminants should not be generally disseminated, so as not to give anyone desiring to cause mischief or a terrorist act an idea of what could be done. The second view argues that information on this topic is already widely available on the Internet and other public sources, and someone intending to cause trouble will easily find the necessary information if they search for it. Unfortunately, water system personnel, especially smaller water systems, may not have ready access to this same information. Therefore, discretion is needed when discussing vulnerabilities, along with specific potential contaminants. Water utility personnel should strive to be at least as generally informed as someone intending to do harm, and hopefully better informed. Secure information networks are now in existence, and others are being developed for dissemination of Federal Bureau of Investigation (FBI) National Infrastructure Protection Center (NIPC) alerts and security-sensitive information to those water utility personnel who need it. Hence, this chapter provides only a general introduction for water utilities to the topic of water system security and the SDWA.

24.2

THREATS TO PUBLIC WATER SYSTEMS

Potential threats to public water systems are many and varied. Three attributes critical to water system users are (Burns et al. 2001) 1. There must be adequate amounts of water on demand. 2. It must be delivered at sufficient pressure. 3. It must be safe to use. Any action or event that affects any of these three factors can be debilitating for a public water system. Physical damage can affect all three. In addition, water quality safety is susceptible to introduction of microorganisms, toxins, chemicals, or radioactive materials. Damage associated with natural or unintentional events, such as earthquakes or chemical spills, can also result from terrorist activity. Threats may be posed by any individual, group, or event that could destroy the facility, halt or suspend operations, otherwise threaten the public health, harm employees, publicly embarrass a utility, require a utility to expend a great deal of time or money, or cause general panic. In assessing threats, security professionals generally consider who or what constitutes a threat and how the identified individual, group, or event could attack a particular system. Having general knowledge of potential chemical or biological threats to a public water supply is important. In general, drinking water regulations do not exist for

24.2 THREATS TO PUBLIC WATER SYSTEMS

569

chemical and biological warfare agents. The term ‘‘weapons of mass destruction’’ (WMD) as typically used includes chemical, biological, toxin(s), or radioactive contaminants that could be introduced deliberately into a public water supply. The Chemical Warfare Convention (CWC) defines a ‘‘toxic chemical’’ to be ‘‘any chemical which through its chemical action on life processes can cause death, temporary incapacitation or permanent harm to humans or animals’’ and specifies that this definition includes ‘‘all such chemicals, regardless of their origin or of their method of production’’ (OPCW 2000). The U.S. Army defines ‘‘chemical warfare (CW) agents’’ as toxic chemical substances developed for military use to produce death, serious injury, or incapacitation through their toxicological effects in exposed humans or animals. Two major categories exist according to broad clinical effects: agents meant to cause death or serious injury, the ‘‘toxic agents;’’ and agents designed to produce only temporary incapcitation, the ‘‘incapacitating agents.’’ The Biological and Toxin Weapons Convention (BTWC) deals with both toxins and living organisms. The BTWC forbids the development, production, stockpiling, or other acquisition or retention of ‘‘microbial or other biological agents, or toxins whatever their origin or method of production, of the types and in quantities that have no justification for prophylactic, protective or other peaceful purposes’’(FAS 2000). Many disease-causing bacteria, protozoa, and viruses fall into this category. Toxins such as botulinum toxin and staphylococcal enterotoxin B (SEB) are more potent than chemical agents, and are also much more toxic than most bacterial species (Madsen 2001). Information is generally limited on the safe drinking water level for chemical and biological WMD. In 1995, the National Research Council (NRC) developed guidelines for chemical warfare agents in military drinking water (NRC 1995). Munro et al. (1999) provided one of the earlier reviews of the sources, fate, and toxicity of chemical warfare agent degradation products. Biological agents as threats to drinking water systems were reviewed by Burrows and Renner (1999), and this article is frequently cited. Also, several toxins have been considered as potential WMD, but their effectiveness as such is problematic (Burrows and Renner 1999, Khan et al. 2001, Madsen 2001). More recently, the Centers for Disease Control (CDC) and USEPA have developed updated information on chemical and biological agents and their susceptibility to water treatment processes. This newer information is being made available only through secure information systems to those agencies and water systems that need it in an emergency. Drinking water facilities have been identified as a logical target of possible terrorist activity (IWP 2001). But successful introduction of an exotic contaminant into a drinking water supply as a WMD is very difficult, and this is generally not considered to be a likely threat (Whitman 2001). In addition, exposure via ingestion is generally less health-threatening than exposure via aerosol inhalation. Assessing the health risks of WMD is complicated by the fact that children may be more sensitive to harmful effects of certain agents (American Academy of Pediatrics 2000). Nearly all known biological warfare agents are intended for aerosol application. Nevertheless, water suppliers may be vulnerable to a different, more common threat:

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contamination by a currently regulated chemical or microorganism, or a common unregulated chemical or microorganism, that a water treatment system is not designed to remove or inactivate because the agent would normally not be expected to occur (Rose 2002). Treatment failures, inadequate treatment, or lack of treatment of poor quality or contaminated source waters are well documented as causes of outbreaks of waterborne disease (see Chapter 3), and may pose a threat equal to or greater than the introduction of an exotic toxin, chemical, or biological agent. In June 1999, CDC convened an expert panel that reviewed the public health threat posed by biological agents. Waterborne agents were considered to have only moderate potential, because of the difficulty of introducing biological agents into a water supply and the effectiveness of treatment (Rotz et al. 2002). Preventing deliberate contamination of the drinking water distribution system is important, especially controlling access to treated water storage tanks. A substantial amount of information regarding chemical, biological, and nuclear terrorist threats, protection measures, and response is generally available (Bolz et al. 2002; GPO 2001, 2002; Haestad 2002; CDC 2001). But not all potential contaminants are generally available, and some of the more readily available substances may not pose a significant threat. For example, gasoline is readily available, and contains over 500 saturated or unsaturated hydrocarbons containing 3–12 carbons. Many components of gasoline are toxic and have significant health effects (Caprino and Togna 1998). But fortunately, gasoline and its components will impart a disagreeable taste and odor if introduced into water, and consumers would not drink gasolinecontaminated water. Many organic compounds impart tastes and odors at concentrations much lower than those associated with adverse health effects. Although it is readily available, gasoline would not be considered a significant public health threat from ingestion of contaminated drinking water, but would pose a potential threat from explosion or fire hazard. Drinking water regulations address the potential health risks associated with naturally occurring radionuclides and potential radiation exposures from vulnerable systems located near nuclear facilities (Pontius 2002). Planning for and responding to widespread radiation exposures from nuclear attack and fallout extends well beyond the capabilities of individual water utilities; coordination with state and federal emergency management agencies is essential. Since September 11, 2001, trends in terrorist attacks and political protests reveal a progression toward ‘‘swarming attacks.’’ These are coordinated attacks using different methods (cyber and physical) against a target and the surrounding infrastructure to cause multiple or cascading effects (NIPC 2002). Fortunately, many water treatment systems may be operated manually and are not necessarily dependent on sophisticated electronic controls.

24.3

SDWA SECURITY PROVISIONS

The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (P.L. 107-188), enacted June 12, 2002, strengthened the security provisions

24.3 SDWA SECURITY PROVISIONS

571

of the SDWA. The SDWA now specifically addresses emergency powers, tampering, vulnerability assessments, emergency response plans, research, and information sharing. 24.3.1

Emergency Powers

USEPA is authorized by SDWA Section 1431 to take actions considered necessary to protect public health in an emergency situation that may present an imminent and substantial danger to public health. Action may be taken on receipt of information that a contaminant is present in or is likely to enter a public water system or an underground source of drinking water. In 2002, authority was granted to USEPA to act if there is a threatened or potential terrorist attack, or other intentional act designed to disrupt the provision of safe drinking water or to adversely impact the safety of drinking water supplied to communities and individuals. This authority may be exercised by the agency only if appropriate state and local authorities have not acted to protect public health. USEPA must consult with the state and local authorities to confirm the correctness of the information on which action is proposed to be taken and to determine the action(s) that state and local authorities are or will be taking. USEPA actions may include, but are not limited to  Issuing orders necessary to protect the health of persons who are or may be users of the water system (including travelers), including orders requiring the provision of alternative water supplies by persons who caused or contributed to the endangerment  Commencing a civil action for appropriate relief, including a restraining order or permanent or temporary injunction Violation, failure, or refusal to comply with a USEPA order may result in a civil penalty of up to $15,000 for each day of violation or failure to comply, if action is brought by USEPA in the appropriate United States district court to enforce the order. 24.3.2

Tampering

Penalties for tampering are summarized in Table 24.1. Any person tampering with a public water system will be imprisoned for not more than 20 years, or fined in accordance with Title 18 of the United States Code, or both, under SDWA Section 1432. Any person attempting to tamper, or threatening to tamper, with a public drinking water system will be imprisoned for not more than 10 years, or fined in accordance with Title 18 of the United States Code, or both. USEPA may bring a civil action in the appropriate United States district court against any person who tampers, attempts to tamper, or threatens to tamper with a public water system. The court may impose on such person a civil penalty of not more than $1,000,000 for such tampering or not more than $100,000 for such attempt or threat. ‘‘Tamper’’

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TABLE 24.1

Penalties for Tampering with Public Water Systems

Action

Civil Penalty

Criminal Penalty

Tampering

$1,000,000 fine

Attempts or threats to tamper

$100,000 fine

Prison sentence 20 years and=or fine in accordance with U.S. Code Prison sentence 10 years or fine in accordance with U.S. Code

means to introduce a contaminant into a public water system with the intention of harming persons or to otherwise interfere with the operation of a public water system with the intention of harming persons.

24.3.3

Vulnerability Assessments

Each community water system (CWS) serving a population of greater than 3300 persons is required by SDWA Section 1433 to conduct an assessment of the vulnerability of its system to a terrorist attack or other intentional acts intended to substantially disrupt the ability of the system to provide a safe and reliable supply of drinking water. The vulnerability assessment is to include, but not be limited to, a review of pipes and constructed conveyances, physical barriers, water collection, pretreatment, treatment, storage and distribution facilities, and electronic, computer, or other automated systems that are utilized by the public water system for the use, storage, or handling of various chemicals, and the operation and maintenance of such system. USEPA, not later than August 1, 2002, after consultation with appropriate departments and agencies of the federal government and with state and local governments, was required to provide baseline information to CWSs required to conduct vulnerability assessments regarding which kinds of terrorist attacks or other intentional acts are the probable threats to substantially disrupt the ability of the system to provide a safe and reliable supply of drinking water or otherwise present significant public health concerns. Each CWS is required to certify to USEPA that the system has conducted an assessment and must submit to USEPA a written copy of the assessment (see Table 24.2). The stated purpose of USEPA collecting the assessments is to ascertain whether TABLE 24.2 Vulnerability Assessment Certification and Submission Deadlines Water System Population Served

Compliance Date

100,000 50,000–100,000 3300–50,000

March 31, 2003 Dec. 31, 2003 June 30, 2004

24.3 SDWA SECURITY PROVISIONS

573

water systems completed them. Several resources are available to assist water systems in conducting vulnerability assessments, including checklists (Lancaster-Brooks 2002) and a water utility risk assessment tool (AWWARF 2002). Public disclosure of sensitive information within the vulnerability assessments is of concern to water utilities. Under the SDWA, information contained in the vulnerability assessments submitted to USEPA is exempt from public disclosure under Section 552 of Title 5 of the United States Code, known as the Freedom of Information Act (FOIA). Submission of the assessment to USEPA cannot be used as the sole basis under state or local law to provide a copy of the assessment to any state, regional, or local governmental entity. But dissemination of sensitive information under state FOIA laws remains a concern, and guidance is available to assist water systems in addressing this issue at the state and local levels (AMWA 2002). By November 30, 2002, USEPA was required to develop protocols necessary to protect the copies of vulnerability assessments submitted and the information contained therein from unauthorized disclosure. The protocols ensure that  Each copy of the assessment, and all information contained in or derived from the assessment, is kept in a secure location.  Only individuals designated by USEPA may have access to the copies of the assessments.  No copy of an assessment, or part of an assessment, or information contained in or derived from an assessment will be available to anyone other than an individual designated by USEPA. Any individual acquiring a vulnerability assessment submitted to USEPA, or any reproduction of an assessment, or any information derived from an assessment, and who knowingly or recklessly reveals an assessment, reproduction, or information may be subject to, on conviction, imprisonment for not more than one year or fined in accordance with the provisions of Chapter 227 of Title 18, United States Code, applicable to Class A misdemeanors, or both, and shall be removed from federal office or employment. A vulnerability assessment, reproduction, or information therefrom may be revealed only to those individuals designated by USEPA. An officer or employee of the United States may discuss the contents of a vulnerability assessment with a state or local official. The security provisions of the SDWA do not authorize the withholding of information from Congress or from any committee or subcommittee of Congress. 24.3.4

Emergency Response Plan

Each CWS serving a population greater than 3300 is required to prepare or revise, where necessary, an emergency response plan that incorporates the results of the required vulnerability assessments. CWSs must certify to USEPA, as soon as reasonably possible but not later than 6 months after the completion of the vulnerability assessment, that the system has completed their plan.

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Emergency response plans are to include, but not be limited to, plans, procedures, and identification of equipment that can be implemented or utilized in the event of a terrorist or other intentional attack on the public water system. These plans must also to include actions, procedures, and identification of equipment that can obviate or significantly lessen the impact of terrorist attacks or other intentional actions on the public health and the safety and supply of drinking water provided to communities and individuals. To the extent possible, CWSs must coordinate with existing Local Emergency Planning Committees established under the Emergency Planning and Community Right-to-Know Act (42 USC 11001 et seq.) when preparing or revising their emergency response plan. A copy of the emergency response plan must be retained for 5 years after the plan has been certified to USEPA. USEPA is required to provide guidance to CWSs serving a population of less than 3300 persons on how to conduct vulnerability assessments, prepare emergency response plans, and address threats from terrorist attacks or other intentional actions designed to significantly affect public health, the safety, or supply of drinking water provided to communities and individuals. There are funds authorized to be appropriated to carry out this section of up to $160,000,000 for the fiscal year 2002, and such sums as may be necessary for the fiscal years 2003–2005. USEPA, in coordination with state and local governments, may use these funds to provide financial assistance to CWSs for conducting vulnerability assessments, to prepare emergency response plans, and for expenses and contracts designed to address basic security enhancements. Examples of security enhancements eligible for funding are listed in Table 24.3. USEPA funding for security enhancements may not include expenditures for personnel costs, or monitoring, operation, or maintenance of facilities, equipment, or systems. USEPA may use up to $5,000,000 to provide grants to CWSs to assist in responding to and alleviating any vulnerability to a terrorist attack or other intentional acts intended to substantially disrupt the ability of the system to provide a safe and reliable supply of drinking water. Up to $5,000,000 may be used to make grants to

TABLE 24.3

Examples of Security Enhancements Eligible for USEPA Funding

Purchase and installation of equipment for detection of intruders Purchase and installation of fencing, gating, lighting, or security cameras Tamperproofing of manhole covers, fire hydrants, and valve boxes Rekeying of doors and locks Improvements to electronic, computer, or other automated systems and remote security systems Participation in training programs, and the purchase of training manuals and guidance materials, relating to security against terrorist attacks Improvements in the use, storage, or handling of various chemicals Security screening of employees or contractor support services Other measures or enhancements not listed above, but that are clearly related to improving water system security, may also be eligible (expenditures for personnel costs, or monitoring, operation, or maintenance of facilities, equipment, or systems are not eligible)

24.3 SDWA SECURITY PROVISIONS

575

CWSs serving a population of less than 3300 persons for activities and projects undertaken in accordance with USEPA’s guidance to small systems. 24.3.5

Reviews and Information Sharing

SDWA Section 1434 requires USEPA to review current and future methods to prevent, detect, and respond to the intentional introduction of chemical, biological, or radiological contaminants into CWSs and source waters. This review is being conducted in consultation with the CDC and appropriate departments and agencies of the federal government and with state and local governments. The review includes  Methods, means, and equipment, including real-time monitoring systems, designed to monitor and detect various levels of chemical, biological, and radiological contaminants or indicators of contaminants and reduce the likelihood that such contaminants can be successfully introduced into public water systems and source water intended to be used for drinking water  Methods and means to provide sufficient notice to operators of public water systems, and individuals served by such systems, of the introduction of chemical, biological, or radiological contaminants and the possible effects of such introduction on public health and the safety and supply of drinking water  Methods and means for developing educational and awareness programs for CWSs  Procedures and equipment necessary to prevent the flow of contaminated drinking water to individuals served by public water systems  Methods, means, and equipment that could negate or mitigate deleterious effects on public health and the safety and supply caused by the introduction of contaminants into water intended to be used for drinking water, including an examination of the effectiveness of various drinking water technologies in removing, inactivating, or neutralizing biological, chemical, and radiological contaminants  Biomedical research into the short-term and long-term impact on public health of various chemical, biological, and radiological contaminants that may be introduced into public water systems through terrorist or other intentional acts Section 1435 requires USEPA to review methods and means by which terrorists or other individuals or groups could disrupt the supply of safe drinking water or take other actions against water collection, pretreatment, treatment, storage, and distribution facilities that could render drinking water significantly less safe for human consumption. The review includes  Methods and means by which pipes and other constructed conveyances utilized in public water systems could be destroyed or otherwise prevented from providing adequate supplies of drinking water meeting applicable public health standards

576

WATER SYSTEM SECURITY

 Methods and means by which collection, pretreatment, treatment, storage, and distribution facilities utilized or used in connection with public water systems and collection and pretreatment storage facilities used in connection with public water systems could be destroyed or otherwise prevented from providing adequate supplies of drinking water meeting applicable public health standards  Methods and means by which pipes, constructed conveyances, collection, pretreatment, treatment, storage, and distribution systems that are utilized in connection with public water systems could be altered or affected so as to be subject to cross-contamination of drinking water supplies  Methods and means by which pipes, constructed conveyances, collection, pretreatment, treatment, storage, and distribution systems that are utilized in connection with public water systems could be reasonably protected from terrorist attacks or other acts intended to disrupt the supply or affect the safety of drinking water  Methods and means by which information systems, including process controls and supervisory control and data acquisition and cyber systems at community water systems, could be disrupted by terrorists or other groups  Methods and means by which alternative supplies of drinking water could be provided in the event of the destruction, impairment, or contamination of public water systems. USEPA is to ensure that all reviews reflect the needs of CWSs of various sizes and various geographic areas of the United States. The agency may consider the vulnerability of, or potential for forced interruption of service for, a region or service area, including CWSs that provide service to the national Capital area. As soon as practicable after reviews have been completed and evaluated, USEPA will disseminate results to CWSs through the water sector Information Sharing and Analysis Center (ISAC, www.amwa.net/isac), and other appropriate means. An authorization of up to $15,000,000 for the fiscal year 2002 and such sums as may be necessary for the fiscal years 2003 through 2005 is included.

24.4

DEPARTMENT OF HOMELAND SECURITY

On November 25, 2002, the Homeland Security Act of 2002 was enacted (P.L. 107296) creating the Department of Homeland Security (DHS), a cabinet-level department within the Executive Branch. The primary mission of the DHS is to prevent terrorist attacks within the United States, reduce the vulnerability of the United States to terrorism, and minimize the damage, and assist in the recovery, from terrorist attacks that do occur within the United States. 24.4.1

DHS Organization

The DHS has five major Divisions, or Directorates:

24.4 DEPARTMENT OF HOMELAND SECURITY

577

1. Border and Transportation Security (BTS), responsible for maintaining the security of the United States’ borders and transportation systems. It is the largest of the Directorates, and contains agencies such as the Transportation Security Administration, U.S. Customs Service, the border security functions of the Immigration and Naturalization Service, Animal & Plant Health Inspection Service, and the Federal Law Enforcement Training Center. 2. Emergency Preparedness and Response (EPR), ensures that our nation is prepared for, and able to recover from, terrorist attacks and natural disasters. 3. Science and Technology (S&T), coordinates DHS’s efforts in research and development, including preparing for and responding to the full range of terrorist threats involving weapons of mass destruction. 4. Information Analysis and Infrastructure Protection (IAIP), identifies and assesses a broad range of intelligence information concerning threats, issues timely warnings, and takes appropriate preventive and protective action. 5. Management, responsible for budget, management, and personnel issues in DHS. In addition to the above five DHS Directorates, several other critical agencies became part of the new department or were newly created:  United States Coast Guard (USCG). The Commandant of the Coast Guard reports directly to the Secretary of Homeland Security. However, the USCG will also work closely with the BTS Directorate as well as maintain its existing independent identity as a military service. Upon declaration of war or when the President so directs, the Coast Guard would operate as an element of the Department of Defense, consistent with existing law.  United States Secret Service. The primary mission of the Secret Service is the protection of the President and other government leaders, as well as security for designated national events. The Secret Service is also the primary agency responsible for protecting U.S. currency from counterfeiters and safeguarding Americans from credit card fraud.  Bureau of Citizenship and Immigration Services. The BTS is responsible for enforcement of immigration laws, but the Bureau of Citizenship and Immigration Services focuses on providing efficient immigration services and easing the transition to American citizenship. The Director of Citizenship and Immigration Services reports directly to the Deputy Secretary of Homeland Defense.  Office of State and Local Government Coordination. This office ensures close coordination between local, state, and federal governments, and between state and local first responders, emergency services, and governments.  Office of Private Sector Liaison. The Office of Private Sector Liaison provides America’s business community a direct line of communication to DHS. The office works directly with individual businesses and through trade associations

578

WATER SYSTEM SECURITY

and other non-governmental organizations to foster dialogue between the Private Sector and DHS on the full range of issues and challenges faced by America’s business sector in the post 9-11 world.

24.4.2 Critical Infrastructure Critical infrastructures provide the simple conveniences of every day life as well as the goods and services Americans need to survive. The USA Patriot Act (P.L. 10756) defines critical infrastructures as those systems and assets, weather physical or virtual, so vital to the United States that the incapacity or destruction of such systems and assets would have a debilitating impact on security, national economy security, national public health or safety, or combination of those matters.

To address critical infrastructure protection, the DHS has organized all of these areas into 13 Critical Infrastructure Sectors including:             

Agriculture Food Water (includes both drinking water and wastewater) Public Health Emergency Services Government Defense Industrial Base Information and Telecommunications Energy Transportation Banking and Finance Chemical Industry and Hazardous Materials Postal and Shipping

The National Infrastructure Simulation and Analysis Center (NISAC) provides support for critical infrastructure protection and continuity through activities related to counter-terrorism, threat assessment, and risk mitigation. These activities include modeling, simulation, and analysis of the systems comprising critical infrastructures, including cyber infrastructure, telecommunications infrastructure, and physical infrastructure, in order to enhance understanding of the large-scale complexity of these systems and to facilitate their modification to mitigate the threats to such systems and to critical infrastructures generally.

24.4 DEPARTMENT OF HOMELAND SECURITY

24.4.3

579

Homeland Security Advisory System

A security advisory system has been created based on a ranking of Threat Conditions. The following Threat Conditions each represent an increasing risk of terrorist attacks. Beneath each Threat Condition are some protective measures suggested by DHS. Federal departments and agencies are to consider these protective measures and are responsible for developing and implementing appropriate protective measures for their agency:

1. Low Condition (Green). This condition is declared when there is a low risk of terrorist attacks.  Refine and exercise as appropriate preplanned protective measures;  Ensure personnel receive proper training on the Homeland Security Advisory System and specific preplanned department or agency protective measures; and  Institutionalize a process to assure that all facilities and regulated sectors are regularly assessed for vulnerabilities to terrorist attacks, and all reasonable measures are taken to mitigate these vulnerabilities. 2. Guarded Condition (Blue). This condition is declared when there is a general risk of terrorist attacks.  Check communications with designated emergency response or command locations;  Review and update emergency response procedures; and  Provide the public with any information that would strengthen its ability to act appropriately. 3. Elevated Condition (Yellow). An Elevated Condition is declared when there is a significant risk of terrorist attacks.  Increase surveillance of critical locations;  Coordinate emergency plans as appropriate with nearby jurisdictions;  Assess whether the precise characteristics of the threat require the further refinement of preplanned Protective Measures; and  Implement, as appropriate, contingency and emergency response plans. 4. High Condition (Orange). A High Condition is declared when there is a high risk of terrorist attacks.  Coordinate necessary security efforts with Federal, State, and local law enforcement agencies or any National Guard or other appropriate armed forces organizations;  Take additional precautions at public events and possibly considering alternative venues or even cancellation;  Prepare to execute contingency procedures, such as moving to an alternate site or dispersing their workforce; and

580

WATER SYSTEM SECURITY

 Restrict threatened facility access to essential personnel only. 5. Severe Condition (Red). A Severe Condition reflects a severe risk of terrorist attacks. Under most circumstances, protective measures for a Severe Condition are not intended to be sustained for substantial periods of time.  Increase or redirect personnel to address critical emergency needs;  Assign emergency response personnel and pre-position and mobilize specially trained teams or resources;  Monitor, redirect, or constrain transportation systems; and  Close public and government facilities.

24.5

FUTURE OUTLOOK

An NRC committee composed of 118 of the nation’s top scientists, engineers, and physicians released a paper in June 2002 entitled ‘‘Making the nation safer: The role of science and technology in countering terrorism’’ (NRC 2002). The paper was presented at a joint House–Senate hearing, and outlines a vast range of activities to both improve use of existing technologies and undertake research and development in certain critical areas, such as water system infrastructure, water monitoring, and information technology. NRC recommendations include increased research into use of sensors and supporting systems to monitor the safety of drinking water and to detect toxic agents in chemical or biological attacks. To reduce the potential hazards of transporting large quantities of industrial chemicals, the report suggests that USEPA might encourage the development of new approaches to on-site production, such as small-scale production of chlorine at water treatment plants. Another research need cited is identification of more effective technologies for removal of chemical contaminants from different media, including water. To address the vulnerability of SCADA systems, the report recommended that encryption techniques, improved firewalls, and cyber detection technologies be used to improve security and reduce the potential for hacking and disruption. The preparedness of USEPA response teams and other agencies to respond to a terrorist incident has been questioned (Pianin 2002), and will likely be closely scrutinized in the future. At this writing (2003), USEPA has formed an Office of Homeland Security to coordinate with the new Department. In addition, USEPA opened the Homeland Security Research Center in Cincinnati, Ohio, on February 24, 2003. This new center is starting with a $50 million annual budget and 80 employees. Its functions include critical infrastructure protection for drinking water and wastewater facilities nationwide. As provisions of the Public Health Security and Bioterrorism Prevention and Response Act are implemented, approaches to water system security will continue to receive close attention and significant improvement. Water system security is now a high priority for government agencies and water utilities, and will continue to be for the foreseeable future.

REFERENCES

581

REFERENCES American Academy of Pediatrics. 2000. Committee on Environmental Health and Committee on Infectious Diseases. Chemical-biological terrorism and its impact on children: A subject review. Pediatrics 105(3):662–670. AMWA. 2002. State FOIA Laws: A Guide to Protecting Sensitive Water Security Information. Washington, DC: Association of Metropolitan Water Agencies. AWWARF. 2002. Risk Assessment Methodology for Water Utilities. Denver: AWWA Research Foundation. Bolz, Jr., F., K. J. Dudonis, and D. P. Schulz. 2002. The Counterterrorist Handbook: Tactics, Procedures, and Techniques. Tampa, FL: CRC Press. Burns, N. L. et al. 2001. Security Analysis & Response for Water Utilities. Denver: AWWA. Burrows, W. D. and S. E. Renner. 1999. Biological warfare agents as threats to potable water. Environ. Health Perspect. 107(12):975–984. Caprino, L. and G. I. Togna. 1998. Potential health effects of gasoline and its constituents: A review of current literature (1990–1997) on toxicological data. Environmental Health Perspectives, 106(3):115–125. CDC. 2001. NIOSH Pocket Guide to Chemical Hazards and Other Databases CD-ROM. DHHS (NIOSH) Publication 2001-145. Cincinnati, OH: National Institute for Occupational Safety and Health (Aug.). FAS. 2000. Federation of American Scientists. Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on Their Destruction. GPO. 2001. 21st Century Complete Guide to Bioterrorism, Biological and Chemical Weapons, Germs and Germ Warfare, Nuclear and Radiation Terrorism CD-ROM. Washington, DC: U.S. Government Printing Office. GPO. 2002. 21st Century Complete Guide to Bioterrorism, Biological and Chemical Weapons, Germs and Germ Warfare, Nuclear and Radiation Terrorism CD-ROM; 2002 Update. Washington, D.C.: U.S. Government Printing Office. Haestad. 2002. Water Security Summit Proc. Waterbury, CT: Haestad Press. IWP. 2001. Drinking water safety emerges as national security concern. In Inside EPA. Washington, DC: Inside Washington Publishers (Sept. 28). Jernigan, J. A. et al. 2001. Bioterrorism-related inhalation anthrax: The first 10 cases reported in the U.S. Emerg. Infect. Diseases 7(6):933–944. Khan, A. S., D. L. Swerdlow, and D. D. Juranek. 2001. Precautions against biological and chemical terrorism directed at food and water supplies. Public Health Rept. 116:3–14. Lancaster-Brooks, R. 2002. Water terrorism: An overview of water and wastewater security problems and solutions. ANSR J. Homeland Security (Feb.) (www.homelandsecurity.org/ journal ). Madsen, J. M. 2001. Toxins as weapons of mass destruction. A comparison and contrast with biological-warfare and chemical-warfare agents. Clin. Lab. Med. 21(3):593–605. Meeks, B. N. 2002. U.S. water supply vulnerable. MSNBC Website (Jan. 14). Mehan, G. T. 2001. Keynote Address. Association of State Drinking Water Administrators 16th Annual Conf. Baltimore, Oct. 23–26, 2001.

582

WATER SYSTEM SECURITY

Munro, N. B. et al. 1999. The sources, fate, and toxicity of chemical warfare agent degradation products. Environ. Health Perspect. 107:933–974. NIPC. 2002. Swarming Attacks: Infrastructure Attacks for Destruction and Disruption. Washington, DC: National Infrastructure Protection Center. NRC. 1995. Guidelines for Chemical Warfare Agents in Military Drinking Water. PB95267142. Washington, DC: National Academy Press. NRC. 2002. Making the Nation Safer: The Role of Science and Technology in Countering Terrorism. Washington, DC: National Research Council. OPCW. 2000. Organization for the Prohibition of Chemical Weapons. Chemical Weapons Convention. Text of the Chemical Weapons Convention. Pianin, E. 2002. EPA found unready for terrorism. Report says chemical, other attacks could overwhelm agency. Washington Post. p. A19 (July 9). Pontius, F. W. 2002. Regulatory compliance planning to ensure water supply safety. J. Am. Water Works Assoc. 94(3):52–64. Rose, J. B. 2002. Water quality security. Environ. Sci. Technol. 36(11):247A–250A. Rotz, L. D., A. S. Khan, S. R. Lilligridge, S. M. Ostroff, and J. M. Hughes. 2002. Public health assessment of potential biological terrorism agents. Emerg. Infect. Diseases 8:225–230. Shannon, E. 2002. A new target: The water pipes. Time.com. (July 22). Whitman, C. T. 2001. Press release and statements Oct. 22, 2002, at the Washington Suburban Sanitary Commission Consolidated Laboratory, Silver Spring, MD. Washington, DC: USEPA.

Appendix A SUMMARY TABLES OF DRINKING WATER STANDARDS AND HEALTH ADVISORIES USEPA OFFICE OF GROUND WATER AND DRINKING WATER USEPA OFFICE OF SCIENCE AND TECHNOLOGY The Drinking Water Standards and Health Advisories tables are revised periodically by USEPA’s Office of Water on an ‘‘as needed’’ basis. The Summer 2002 edition of the tables has retained the content and format changes introduced in the Summer 2000 edition and has added the Chemical Abstracts Service Registry Numbers (CASRN) for the chemical contaminants. The following changes should be kept in mind when using the tables (Tables A.1–A.8): Reference dose (RfD) values have been updated to reflect the values in the Integrated Risk Information System (IRIS), and the Drinking Water Equivalent Level (DWEL) has been calculated accordingly. Thus, both the RfD and DWEL will differ from the values in the Health Advisory document if the IRIS RfD is more recent than the Health Advisory value. The RfD values from IRIS that differ from the values in the Health Advisory documents are given in bold type (in Table A.2 only). For unregulated chemicals with a new IRIS RfD, the lifetime Health Advisory was calculated from the DWEL using the relative source contribution value published in the Health Advisory. For regulated chemicals, where the revised lifetime value differed from the maximum contaminant level goal (MCLG), no lifetime value was provided in the table. For regulated chemicals, the cancer group designation and 10
4 cancer risk reflect the status at the time of regulation. For unregulated chemicals, the cancer group designation and 10
4 cancer risk reflect the values presently on IRIS. New cancer group designations and 10
4 cancer risk values are given in bold type. Several pesticides listed in IRIS have been reevaluated by the Office of Pesticide Programs (OPP) resulting in an RfD other than that in IRIS. For these pesticides, the IRIS value is listed in the table, and the newer OPP value is given in a footnote. Drinking Water Regulation and Health, Edited by Frederick W. Pontius. ISBN 0-471-41554-5 # 2003 John Wiley & Sons, Inc.

583

584

SUMMARY TABLES OF DRINKING WATER STANDARDS AND

In some cases there is a Health Advisory value for a contaminant but there is no reference to a Health Advisory document. These Health Advisory values can be found in the Drinking Water Criteria Document for the contaminant. With a few exceptions, the Health Advisory values have been rounded to one significant figure. The Drinking Water Standards and Health Advisories tables may be reached from the Water Science homepage at http://www.epa.gov/waterscience The tables are accessed under the Health Advisories heading. Copies may be ordered free of charge from SAFE DRINKING WATER HOTLINE 1-800-426-4791 Monday thru Friday, 9:00 AM to 5:30 PM EST Copies of the supporting technical documentation for the health advisories can be ordered for a fee on the Internet at http://www.epa.gov/OST/orderpubs.html or from Educational Resources Information Center (ERIC) 1929 Kenny Road Columbus, OH 43210-1080 Telephone number 614-292-6717; 1-800-276-0462 Fax 614-292-0263 email [email protected] Payment by purchase order/check/Visa or Mastercard For further information regarding the Drinking Water Standards and Health Advisories, call the Safe Drinking Water Hotline at 1-800-426-4791 or 703-285-1093.

DEFINITIONS The following definitions for terms used in the tables are not all-encompassing, and should not be construed to be ‘‘official’’ definitions. They are intended to assist the user in understanding terms found on the following pages. Action Level: The concentration of a contaminant that, if exceeded, triggers treatment or other requirements that a water system must follow. For lead or copper it is the level that, if exceeded in over 10% of the homes tested, triggers treatment.

DEFINITIONS

585

Cancer Group: A qualitative weight-of-evidence judgment as to the likelihood that a chemical may be a carcinogen for humans. Each chemical is placed into one of the following five categories: Group A B

C D E

Category Human carcinogen Probable human carcinogen: B1 indicates limited human evidence B2 indicates sufficient evidence in animals and inadequate or no evidence in humans Possible human carcinogen Not classifiable as to human carcinogenicity Evidence of noncarcinogenicity for humans

This categorization is based on EPA’s 1986 Guidelines for Carcinogen Risk Assessment. The Proposed Guidelines for Carcinogen Risk Assessment, which were published in 1996, when final, will replace the 1986 cancer guidelines. 10-4 Cancer Risk: The concentration of a chemical in drinking water corresponding to an excess estimated lifetime cancer risk of 1 in 10,000. Drinking Water Advisory: A nonregulatory concentration of a contaminant in water that is likely to be without adverse effects on both health and aesthetics. DWEL: Drinking water equivalent level. A lifetime exposure concentration protective of adverse, noncancer health effects, that assumes all of the exposure to a contaminant is from drinking water. HA: Health Advisory. An estimate of acceptable drinking water levels for a chemical substance based on health effects information; a Health Advisory is not a legally enforceable federal standard, but serves as technical guidance to assist federal, state, and local officials. One-Day HA: The concentration of a chemical in drinking water that is not expected to cause any adverse noncarcinogenic effects for up to one day of exposure. The One-Day HA is normally designed to protect a 10-kg child consuming 1 l of water per day. Ten-Day HA: The concentration of a chemical in drinking water that is not expected to cause any adverse noncarcinogenic effects for up to 10 days of exposure. The Ten-Day HA is also normally designed to protect a 10-kg child consuming 1 l of water per day. Lifetime HA: The concentration of a chemical in drinking water that is not expected to cause any adverse noncarcinogenic effects for a lifetime of exposure. The Lifetime HA is based on exposure of a 70-kg adult consuming 2 l of water

586

SUMMARY TABLES OF DRINKING WATER STANDARDS AND

per day. The Lifetime HA for Group C carcinogens includes an adjustment for possible carcinogenicity. LED10: Lower limit on effective dose10. The 95% lower confidence limit of the dose of a chemical needed to produce an adverse effect in 10% of those exposed to the chemical, relative to the control. MCLG: Maximum contaminant level goal. A nonenforceable health goal that is set at a level at which no known or anticipated adverse effect on the health of persons occurs and that allows an adequate margin of safety. MCL: Maximum contaminant level. The highest level of a contaminant that is allowed in drinking water. MCLs are set as close to the MCLG as feasible using the best available analytical and treatment technologies and taking cost into consideration. MCLs are enforceable standards. RfD: Reference dose. An estimate (with uncertainty spanning perhaps an order of magnitude) of a daily oral exposure to the human population (including sensitive subgroups) that is likely to be without an appreciable risk of deleterious effects during a lifetime. SDWR: Secondary Drinking Water Regulations. Nonenforceable federal guidelines regarding cosmetic effects (such as tooth or skin discoloration) or aesthetic effects (such as taste, odor, or color) of drinking water. TT: Treatment technique. A required process intended to reduce the level of a contaminant in drinking water.

ABBREVIATIONS D F NA NOAEL OPP P Reg TT

Draft Final Not applicable No-observed-adverse-effect level Office of Pesticide Programs Proposed Regulation Treatment technique

REFERENCES USEPA. 1975. National Interim Primary Drinking Water Regulations. Fed. Reg. 40(248): 59566–59588 (Dec. 24, 1975).

REFERENCES

587

USEPA. 1979. National Secondary Drinking Water Regulations; Final Rule. Fed. Reg. 44(140): 42195 (July 19, 1979). USEPA. 1986. Fluoride; Final Rule. Fed. Reg. 51(63):11396 (April 2, 1986). USEPA. 1987. Volatile SOCs. Final Rule. Fed. Reg. 2(130):25690–25717 (July 8, 1987). USEPA. 1989a. Filtration, Disinfection, Turbidity, Giardia lamblia, viruses, Legionella, and Heterotrophic Bacteria. Final Rule. Fed. Reg. 54(124):27486–27541 (June 29, 1989). USEPA. 1989b. Total Coliforms (including Fecal Coliforms and E. coli). Final Rule. Fed. Reg. 54(124):27544–27568 (June 29, 1989). USEPA. 1991a. SOCs and IOCs. Final Rule. Fed. Reg. 56(20):3526–3597 (Jan. 30, 1991). USEPA. 1991b. Lead and Copper. Final Rule. Fed. Reg. 56(110):26460–26564 (June 7, 1991). USEPA. 1992a. Aldicarb, Aldicarb Sulfoxide, Aldicarb Sulfone. Notice of Postponement of Certain Provisions of the Final Rule. Fed. Reg. 57(102):22178–22179 (May 27, 1992). USEPA. 1992b. SOCs and IOCs. Final Rule. Fed. Reg. 57(138):31776–31849 (July 17, 1992). USEPA. 1998a. Disinfectants and Disinfection Byproducts. Final Rule. Fed. Reg. 63(241): 69390–69476 (Dec. 16, 1998). USEPA. 1998b. Interim Enhanced Surface Water Treatment. Final Rule. Fed. Reg. 63(241): 69478–69521 (Dec. 16, 1998). USEPA. 1999. Radon. Proposed Rule. Fed. Reg. 64(211):59246–59378 (Nov. 2, 1999). USEPA 2000. Radionuclides. Final Rule. Fed. Reg. 65(236):76708–76753 (Dec. 7, 2000). USEPA. 2001. National Primary Drinking Water Regulations; Arsenic and Clarifications to Compliance and New Source Contaminants Monitoring. Final Rule. Fed. Reg. 66(14): 6976–7066 (Jan. 22, 2001). USEPA. 2002. National Primary Drinking Water Regulations; Long-Term 1 Enhanced Surface Water Treatment Rule. Fed. Reg. 67(9):1812 (Jan. 14, 2002).

588 TTc 5.0%d

N=A

Zero

Zero

Heterotrophic plate count (HPC)

Legionella

Total coliforms (including fecal coliform and E. coli)

TTc

TTc

Zero

Giardia lamblia

TTc

MCIa or TT1 (mg=L)b

Zero

MCLGa (mg=L)b

Microorganisms Cryptosporidium

Contaminant

TABLE A.1

Gastrointestinal illness (e.g., diarrhea, vomiting, cramps) Gastrointestinal illness (e.g., diarrhea, vomiting, cramps) HPC has no health effects— it is an analytic method used to measure the variety of bacteria that are common in water; the lower the concentration of bacteria in drinking water, the better maintained the water system is Legionnaire’s disease, a type of pneumonia Not a health threat in itself; it is used to indicate whether other potentially harmful bacteria may be presente

Potential Health Effects from Exposure above the MCL

Found naturally in water; multiplies in heating systems Coliforms are naturally present in the environment; as well as feces; fecal coliforms and E. coli comeonly from human and animal fecal waste

HPC measures a range of bacteria that are naturally present in the environment

Human and animal fecal waste

Human and animal fecal waste

Common Sources of Contaminant in Drinking Water

589

1.0

0.060 0.10

0.8

N=Af

Noneg

Chlorite

Haloacetic acids (HAA5) Total trihalomethanes (TTHMs)

0.010

TTc

Zero

Zero

Viruses (enteric)

TTc

Disinfectants Bromate

N=A

Turbidity

Liver, kidney or central nervous system problems; increased risk of cancer

Anemia; infants and young children: nervous system effects Increased risk of cancer

Increased risk of cancer

Turbidity is a measure of the cloudiness of water, used to indicate water quality and filtration effectiveness (e.g., whether disease-causing organisms are present); higher turbidity levels are often associated with higher levels ;of disease-causing microorganisms such as viruses, parasites and some bacteria— organisms can cause these symptoms such as nausea, cramps, diarrhea, and associated headaches Gastrointestinal illness (e.g., diarrhea, vomiting, cramps)

(continued )

Byproduct of drinking water disinfection

Byproduct of drinking water disinfection

Byproduct of drinking water disinfection Byproduct of drinking water disinfection

Human and animal fecal waste

Soil runoff

590

Barium

Asbestos (fibers > 10 mm)

Arsenic

2

7 MFL

7 million fibers per liter (MFL)

2

0.010 as of 1=23=06

0.006

zero as of 1=23=06g

0.006

MRDL ¼ 0.8a

MRDLG ¼ 0.8a

Chlorine dioxide (as ClO2)

Inorganic chemicals Antimony

MRDL ¼ 4.0a

MRDaLG ¼ 4

Chlorine (as Cl2)

0.080

MCIa or TT1 (mg=L)b

MRDL ¼ 4.0a

N=Af

b

MCLG (mg=L)

a

MRDaLG ¼ 4

(Continued)

Disinfection byproducts Chloramines (as Cl2)

Contaminant

TABLE A.1

Increase in blood pressure

Skin damage or problems with circulatory systems, and may have increased risk of getting cancer Increased risk of developing benign intestinal polyps

Increase in blood cholesterol; decrease in blood sugar

Eye=nose irritation; stomach discomfort, anemia Eye=nose irritation; stomach discomfort Anemia; infants and young children: nervous system effects

Potential Health Effects from Exposure above the MCL

Discharge from petroleum refineries; fire retardants; ceramics; electronics; solder Erosion of natural deposits; runoff from orchards, runoff from glass and electronics production wastes Decay of asbestos cement in water mains; erosion of natural deposits Discharge of drilling wastes; discharge from metal refineries; erosion of natural deposits

Water additive used to control microbes Water additive used to control microbes Water additive used to control microbes

Common Sources of Contaminant in Drinking Water

591

0.004

0.005

0.1

1.3

0.2

4.0

Beryllium

Cadmium

Chromium (total)

Copper

Cyanide (as free cyanide)

Fluoride 4.0

0.2

TTh action level ¼ 1.3

0.1

0.005

0.004

Bone disease (pain and tenderness of the bones); children may get mottled teeth

Short-term exposure—gastrointestinal distress; long-term exposure—liver or kidney damage; people with Wilson’s disease should consult their personal physicians if the amount of copper in their water exceeds the action level Nerve damage or thyroid problems

Allergic dermatitis

Kidney damage

Intestinal lesions

Discharge from steel=metal factories; discharge from plastic and fertilizer factories Water additive that promotes strong teeth; erosion of natural deposits; discharge from fertilizer and aluminum factories (continued )

Discharge from metal refineries and coal-burning factories; discharge from electrical, aerospace, and defense industries Corrosion of galvanized pipes; erosion of natural deposits; discharge from metal refineries; runoff from waste batteries and paints Discharge from steel and pulp mills; erosion of natural deposits Corrosion of household plumbing systems; erosion of natural deposits

592 10

1

10

1

Nitrate (measured as nitrogen)

Nitrite (measured as nitrogen)

Infants aged < 6 months who drink water containing nitrate in excess of the MCL could become seriously ill and, if untreated, may die; symptoms include shortness of breath and blue-baby syndrome Infants aged < 6 months who drink water containing nitrite in excess of the MCL could become seriously ill and, if untreated, may die; symptoms include shortness of breath and blue-baby syndrome

0.002

Infants and children—delays in physical or mental development (children could show slight deficits in attention span and learning abilities); adults—kidney problems, high blood pressure Kidney damage

TTh; action level ¼ 0.015

0.002

Potential Health Effects from Exposure above the MCL

MCIa or TT1 (mg=L)b

Mercury (inorganic)

MCLGa (mg=L)b

Zero

(Continued)

Lead

Contaminant

TABLE A.1

Runoff from fertilizer use; leaching from septic tanks, sewage; erosion of natural deposits

Erosion of natural deposits; discharge from refineries and factories; runoff from landfills and croplands Runoff from fertilizer use; leaching from septic tanks, sewage; erosion of natural deposits

Corrosion of household plumbing systems; erosion of natural deposits

Common Sources of Contaminant in Drinking Water

593

Zero

0.003

Zero

Zero

0.04

Zero

Zero

Alachlor

Atrazine

Benzene

Benzo(a)pyrene (PAHs)

Carbofuran

Carbon tetrachloride

Chlordane

Zero

0.0005

Thallium

Organic chemicals Acrylamide

0.05

Selenium

0.002

0.005

0.04

0.0002

0.005

0.003

0.002

TTi

0.002

0.05

Problems with blood, nervous system, or reproductive system Liver problems/ increased risk of cancer Liver or nervous system problems; increased risk of cancer

Nervous system or blood problems; increased risk of cancer Eye, liver, kidney, or spleen problems; anemia; increased risk of cancer Cardiovascular system or reproductive problems Anemia; decrease in blood platelets; increased risk of cancer Reproductive difficulties; increased risk of cancer

Hair or fingernail loss; numbness in fingers or toes; circulatory problems Hair loss; changes in blood; kidney, intestine, or liver problems

(continued )

Runoff from herbicide used on row crops Discharge from factories; leaching from gas storage tanks and landfills Leaching from linings of water storage tanks and distribution lines Leaching of soil fumigant used on rice and alfalfa Discharge from chemical plants and other industrial activities Residue of banned termiticide

Runoff from herbicide used on row crops

Added to water during sewage=wastewater treatment

Discharge from petroleum refineries; erosion of natural deposits; discharge from mines Leaching from ore-processing sites; discharge from electronics, glass, and drug factories

594

0.6

0.075

Zero

0.007

0.07

0.1

Zero

Zero

o-Dichlorobenzene

p-Dichlorobenzene

1,2-Dichloroethane

1,1-Dichloroethylene

cis-1,2-Dichloroethylene

trans-1,2-Dichloroethylene

Dichloromethane

1,2-Dichloropropane

0.005

0.005

0.1

0.07

0.007

0.005

0.075

Liver problems; increased risk of cancer Increased risk of cancer

Liver problems

Liver problems

Liver problems

Liver, kidney, or circulatory system problems Anemia; liver, kidney, or spleen damage; changes in blood Increased risk of cancer

0.0002

Zero

1,2-Dibromo-3chloropropane (DBCP) 0.6

Reproductive difficulties; increased risk of cancer

0.2

0.2

Dalapon

Liver or kidney problems

Potential Health Effects from Exposure above the MCL

Kidney, liver, or adrenal gland problems Minor kidney changes

0.1

MCIa or TT1 (mg=L)b

0.07

0.07

2,4-D

MCLGa (mg=L)b

0.1

(Continued)

Chlorobenzene

Contaminant

TABLE A.1

Discharge from chemical and agricultural chemical factories Runoff from herbicide used on row crops Runoff from herbicide used on rights of way Runoff=leaching from soil fumigant used on soybeans, cotton, pineapples, and orchards Discharge from industrial chemical factories Discharge from industrial chemical factories Discharge from industrial chemical factories Discharge from industrial chemical factories Discharge from industrial chemical factories Discharge from industrial chemical factories Discharge from drug and chemical factories Discharge from industrial chemical factories

Common Sources of Contaminant in Drinking Water

595

0.4

Zero

0.007

Zero

0.02 0.1 0.002 Zero

0.7

Zero

0.7

Zero

Di(2-ethylhexyl)adipate

Di(2-ethylhexyl)phthalate

Dinoseb

Dioxin(2,3,7,8-TCDD)

Diquat Endothall Endrin Epichlorohydrin

Ethylbenzene

Ethylene dibromide

Glyphosate

Heptachlor 0.0004

0.7

0.00005

0.7

0.02 0.1 0.002 TTi

0.00000003

0.007

0.006

0.4

Problems with liver, stomach, reproductive system, or kidneys; increased risk of cancer Kidney problems; reproductive difficulties Liver damage; increased risk of cancer

Liver or kidney problems

Cataracts Stomach and intestinal problems Liver problems Increased cancer risk, and over a long period of time, stomach problems

Reproductive difficulties; increased risk of cancer

General toxic effects or reproductive difficulties Reproductive difficulties; liver problems; increased risk of cancer Reproductive difficulties

(continued )

Residue of banned termiticide

Runoff from herbicide use

Runoff from herbicide used on soybeans and vegetables Emissions from waste incineration and other combustion; discharge from chemical factories Runoff from herbicide use Runoff from herbicide use Residue of banned insecticide Discharge from industrial chemical factories; an impurity of some water treatment chemicals Discharge from petroleum refineries Discharge from petroleum refineries

Discharge from chemical factories Discharge from rubber and chemical factories

596 0.0002

0.0002

0.04

0.2

Zero

Zero

0.5 0.004 0.1

Methoxychlor

Oxamyl (Vydate)

Polychlorinated biphenyls (PCBs)

Pentachlorophenol

Picloram Simazine Styrene 0.5 0.004 0.1

0.001

0.0005

0.2

0.04

Skin changes; thymus gland problems; immune deficiencies; reproductive or nervous system difficulties; increased risk of cancer Liver or kidney problems; increased cancer risk Liver problems Problems with blood Liver, kidney, or circulatory system problems

Slight nervous system effects

Reproductive difficulties

Liver or kidney problems

0.05

0.05

0.001

Hexachlorocyclopent adiene Lindane

Zero

Potential Health Effects from Exposure above the MCL Liver damage; increased risk of cancer Liver or kidney problems; reproductive difficulties; increased risk of cancer Kidney or stomach problems

MCIa or TT1 (mg=L)b 0.0002

Hexachlorobenzene

MCLGa (mg=L)b

Zero

(Continued)

Heptachlor epoxide

Contaminant

TABLE A.1

Discharge from wood-preserving factories Herbicide runoff Herbicide runoff Discharge from rubber and plastic factories; leaching from landfills

Discharge from metal refineries and agricultural chemical factories Discharge from chemical factories Runoff=leaching from insecticide used on cattle, lumber, gardens Runoff=leaching from insecticide used on fruits, vegetables, alfalfa, livestock Runoff=leaching from insecticide used on apples, potatoes, and tomatoes Runoff from landfills; discharge of waste chemicals

Breakdown of heptachlor

Common Sources of Contaminant in Drinking Water

597

4 mrem=year

0.003

Zero

Zero

10

Noneg

Noneg

1,1,2-Trichloroethane

Trichloroethylene

Vinyl chloride

Xylenes (total)

Radionuclides Alpha particles

Beta particles and photon emitters

15 pCi=L

0.20

1,1,1-Trichloroethane

10

0.002

0.005

0.005

0.2

0.05 0.07

0.05 0.07

2,4,5-TP (Silvex) 1,2,4-Trichlorobenzene

0.003

1

0.005

Zero

1

Zero

Toxaphene

Toluene

Tetrachloroethylene

Increased risk of cancer

Increased risk of cancer

Nervous system damage

Liver, nervous system, or circulatory problems Liver, kidney, or immune system problems Liver problems; increased risk of cancer Increased risk of cancer

Liver problems; increased risk of cancer Nervous system, kidney, or liver problems Kidney, liver, or thyroid problems; increased risk of cancer Liver problems Changes in adrenal glands

Erosion of natural deposits of certain minerals that are radioactive and may emit a form of radiation known as alpha radiation Decay of natural and humanmade deposits of certain minerals that are radioactive and may emit forms of radiation known as photons and beta radiation (continued )

Residue of banned herbicide Discharge from textile finishing factories Discharge from metal degreasing sites and other factories Discharge from industrial chemical factories Discharge from metal degreasing sites and other factories Leaching from PVC pipes; discharge from plastic factories Discharge from petroleum factories; discharge from chemical factories

Discharge from factories and dry cleaners Discharge from petroleum factories Runoff=leaching from insecticide used on cotton and cattle

598

(Continued)

Increased risk of cancer, kidney toxicity

30 mg=L

Zero

Erosion of natural deposits

Erosion of natural deposits

Common Sources of Contaminant in Drinking Water

 Treatment technique (TT)—a required process intended to reduce the level of a contaminant in drinking water.

 Maximum residual disinfectant level (MRDL)—the highest level of a disinfectant allowed in drinking water. There is convincing evidence that addition of a disinfectant is necessary for control of microbial contaminants.

 Maximum residual disinfectant level goal (MRDLG)—the level of a drinking water disinfectant below which there is no known or expected risk to health. MRDLGs do not reflect the benefits of the use of disinfectants to control microbial contaminants.

 Maximum contaminant level (MCL)—the highest level of a contaminant that is allowed in drinking water. MCLs are set as close to MCLGs as feasible using the best available treatment technology and taking cost into consideration. MCLs are enforceable standards.

 Maximum contaminant level goal (MCLG)—the level of a contaminant in drinking water below which there is no known or expected risk to health. MCLGs allow for a margin of safety and are nonenforceable public health goals.

All values in this column except those for disinfection byproducts are MCLG or MCL; disinfection byproduct values are MRDL. Definitions are as follows:

Increased risk of cancer

5 pCi=L

Noneg

Potential Health Effects from Exposure above the MCL

MCIa or TT1 (mg=L)b

MCLGa (mg=L)b

c

 Legionella: No limit, but EPA believes that if Giardia and viruses are removed=inactivated, Legionella will also be controlled.

 Giardia lamblia: 99.0% removal=inactivation.  Viruses: 99.99% removal=inactivation.

 Cryptosporidium (as of 1=1=02 for systems serving > 10,000 and 1=14=05 for systems serving < 10,000) 99% removal.

Units are in milligrams per liter (mg=L) unless otherwise noted. Milligrams per liter are equivalent to parts per million (ppm). USEPA’s surface water treatment rules require systems using surface water or groundwater under the direct influence of surface water to (1) disinfect their water and (2) filter their water or meet criteria for avoiding filtration so that the following contaminants are controlled at the following levels:

b

a

Radium 226 and radium 228 (combined) Uranium

Contaminant

TABLE A.1

599

Source: U.S. Environmental Protection Agency, Office of Water (4606), EPA 816-F-02-013 (www.epa.gov=safewater), July 2002. For more information, call the Safe Drinking Water Hotline, 1-800-426-4791.

g MCLGs were not established before the 1986 Amendments to the Safe Drinking Water Act. The standard for this contaminant was set prior to 1986. Therefore, there is no MCLG for this contaminant. h Lead and copper are regulated by a treatment technique that requires systems to control the corrosiveness of their water. If more than 10% of tapwater samples exceed the action level, water systems must take additional steps. For copper, the action level is 1.3 mg=L, and for lead is 0.015 mg=L. i Each water system must certify, in writing, to the state that when it uses acrylamide and=or epichlorohydrin to treat water, the combination (or product) of dose and monomer level does not exceed the levels specified, as follows: acrylamide ¼ 0.05% dosed at 1 mg=L (or equivalent); epichlorohydrin ¼ 0.01% dosed at 20 mg=L (or equivalent).

 Trihalomethanes: bromodichloromethane (zero); bromoform (zero); dibromochloromethane (0.06 mg=L)

 Haloacetic acids: dichloroacetic acid (zero); trichloroacetic acid (0.3 mg=L)

d No more than 5.0% samples total coliform-positive in a month. (For water systems that collect fewer than 40 routine samples per month, no more than one sample can be total coliform-positive per month.) Every sample that has total coliform must be analyzed for either fecal coliforms or E. coli if there are two consecutive TC-positive samples, and one is also positive for E. coli fecal coliforms, and the system has an acute MCL violation. e Fecal coliform and E. coli are bacteria whose presence indicates that the water may be contaminated with human or animal wastes. Disease-causing microbes (pathogens) in these wastes can cause diarrhea, cramps, nausea, headaches, or other symptoms. These pathogens may pose a special health risk for infants, young children, and people with severely compromised immune systems. f Although there is no collective MCLG for this contaminant group, there are individual MCLGs for some of the individual contaminants:

 Filter backwash recycling: the Filter Backwash Recycling Rule requires systems that recycle to return specific recycle flows through all processes of the system’s existing conventional or direct filtration system or at an alternate location approved by the state.

 HPC: No more than 500 bacterial colonies per milliliter.  Long Term 1 Enhanced Surface Water Treatment (effective date: Jan. 14, 2005); surface water systems or ground water under direct influence (GWUDI) systems serving fewer than 10,000 people must comply with the applicable Long Term 1 Enhanced Surface Water Treatment Rule provisions (e.g., turbidity standards, individual filter monitoring, Cryptosporidium removal requirements, updated watershed control requirements for unfiltered systems).

 Turbidity: At no time can turbidity (cloudiness of water) go above 5 nephelolometric turbidity units (NTU); systems that filter must ensure that the turbidity go no higher than 1 NTU (0.5 NTU for conventional or direct filtration) in at least 95% of the daily samples in any month. As of January 1, 2002, turbidity may never exceed 1 NTU, and must not exceed 0.3 NTU in 95% of daily samples in any month.

600

Zero Zero —

—

—

F Fd Fd Fd — — — — F — — —

F F —

—

—

71-43-2 50-32-8 205-99-2

191-24-2

207-08-9

F

— — Zero — Zero 0.001 0.001 0.001 — — — — 0.003 — — —

MCLG (mg=L)

—

Status Reg.

83-32-9 62476-59-9 79-06-1 107-13-1 15972-60-8 116-06-3 1646-88-4 1646-87-3 309-00-2 834-12-8 7773-06-0 120-12-7 1912-24-9 114-26-1 25057-89-0 56-55-3

CASRN Number

Standards

—

—

0.005 0.0002 —

— — TT1 — 0.002 0.003 0.003 0.004 — — — — 0.003 — — —

MCL (mg=L)

—

—

F 1987 — —

— F 1988 F 1987 — F 1988 F 1995 F 1995 F 1995 F 1992 F 1988 F 1988 — F 1988 F 1988 F 1999 —

Status HA Document

—

—

0.2 — —

— 2 1.5 — 0.1 0.01 0.01 0.01 0.0003 9 20 — — 0.04 0.3 —

1-day (mg=L)

—

—

0.2 — —

— 2 0.3 — 0.1 0.01 0.01 0.01 0.0003 9 20 — — 0.04 0.3 —

10-day (mg=L)

10-kg Child

Drinking Water Standards and Health Advisories (Summer 2002)

Organics Acenaphthene Acifluorfen (sodium) Acrylamide Acrylonitrile Alachlor Aldicarbc Aldicarb sulfonec Aldicarb sulfoxidec Aldrin Ametryn Ammonium sulfamate Anthracene (PAH)e Atrazinef Baygon Bentazon Benz[a]anthracene (PAH) Benzene Benzo[a]pyrene (PAH) Benzo[b]fluoranthene (PAH) Benzo[g,h,i]perylene (PAH) Benzo[k]fluoranthene (PAH)

Chemicals

TABLE A.2

—

—

— — —

0.06 0.01 0.0002 — 0.01 0.001 0.001 0.001 0.00003 0.009 0.2 0.3 0.035 0.004 0.03 —

RfD (mg=kg=day)

—

—

— — —

2 0.4 0.007 — 0.4 0.04 0.04 0.04 0.001 0.3 8 10 1 0.1 1 —

DWEL (mg=L)

Health Advisories

—

—

— — —

0.003 0.2 —

— — — — — — — — — 0.06 2 —

Lifetime (mg=L)

—

—

0.1 0.0005 —

— 0.1 0.0008 0.006 0.04b — — — 0.0002 — — — — — — —

mg=L at 10
4 Cancer Risk

B2

D

A B2 B2

— B2 B2 B1 B2 D D D B2 D D D C C E B2

Cancer Group

601

bis-2-Chloroisopropyl ether Bromacil Bromobenzene Bromochloromethane Bromodichloromethanef (THM) Bromoform (THM) Bromomethane Butyl benzyl phthalate (PAE)h Butylate Carbaryl Carbofuranf Carbon tetrachloride Carboxin Chloramben Chlordane Chloroform (THM) Chloromethane Chlorophenol (2-) Chlorothalonil Chlorotoluene oChlorotoluene pChlorpyrifosj Chrysene (PAH) Cyanazine Cyanogen chloridef 2,4-D(2,4dichlorophenoxyacetic acid) DCPA (Dacthal) Dalapon (sodium salt) Di(2-ethylhexyl)adipate Di(2-ethylhexyl)phthalate (PAE) Diazinon

— — 0.04 Zero — — Zero Zero — — — — — — — — — 0.07

— 0.2 0.4 Zero

— — F F — — F F — — — — — — — — — F

— F F F

2008-41-5 63-25-2 1563-66-2 56-23-5 5234-68-4 133-90-4 57-74-9 67-66-3 74-87-3 95-57-8 1897-45-6 95-49-8 106-43-4 2921-88-2 218-01-9 21725-46-2 506-77-4 94-75-7

1861-32-1 75-99-0 103-23-1 117-81-7

—

Zero — —

F — —

75-25-2 74-83-9 85-68-7

—

— — — Zero

— — — F

314-40-9 108-86-1 74-97-5 75-27-4

333-41-5

—

—

39638-32-9

—

— 0.2 0.4 0.006 F 1988

F 1988 F 1989 — —

F 1989 F 1988 F 1987 F 1987 F 1988 F 1988 F 1987 D 1993 F 1989 D 1994 F 1988 F 1989 F 1989 F 1992 — D 1996 — F 1987

D 1993 D 1989 —

0.08g — — — — 0.04 0.005 — — 0.002 0.08f — — — — — — — — — 0.07

F 1988 D 1986 F 1989 D 1993

F 1989

— — — 0.08g

—

0.02

80 3 20 —

2 1 0.05 4 1 3 0.06 4 9 0.5 0.2 2 2 0.03 — 0.1 0.05 1

5 0.1 —

5 4 50 6

4

0.02

80 3 20 —

2 1 0.05 0.2 1 3 0.06 4 0.4 0.5 0.2 2 2 0.03 — 0.1 0.05 0.3

2 0.1 —

5 4 1 6

4

0.00009

0.01 0.03 0.6 0.02

0.05 0.1 0.005 0.0007 0.1 0.015 0.0005 0.01 0.004 0.005 0.015 0.02 0.02 0.003 — 0.002 0.05 0.01

0.02 0.001 0.2

0.1 — 0.01 0.02

0.04

0.003

0.4 0.9 20 0.7

2 4 0.2 0.03 4 0.5 0.02 0.4 0.1 0.2 0.5 0.7 0.7 0.1 — 0.07 2 0.4

0.7 0.05 7

5 — 0.5 0.7

1

0.0006

0.07 0.2 0.4 —

0.4 0.7 0.04 — 0.7 0.1 — — 0.03 0.04 — 0.1 0.1 0.02 — 0.001 — 0.07

— 0.01 —

0.09 — 0.09 —

0.3

—

— — 3 0.3

— — — 0.03 — — 0.01 — — — 0.15 — — — — — — —

0.4 — —

— — — 0.06

—

E (continued )

D D C B2

D D

D D E B2 D D B2 B2i D D B2 D D D B2

B2 D C

C D D B2

D

602

Dibromochloromethane (THM)f Dibromochloropropane (DBCP) Dibutyl phthalate (PAE) Dicamba Dichloroacetic acidf Dichlorobenzene oDichloroboenzene m-m Dichlorobenzene pDichlorodifluoromethane Dichloroethane (1,2-) Dichloroethylene (1,1-) Dichloroethylene (cis-1,2-) Dichloroethylene (trans-1,2-) Dichloromethane Dichlorophenol (2,4-) Dichloropropane (1,2-) Dichloropropene (1,3-) Dieldrin Diethyl phthalate (PAE) Diisopropyl methylphosphonate Dimethrin

Chemicals

TABLE A.2 (Continued)

0.06

Zero

— — Zero 0.6 — 0.075 — Zero 0.007 0.07

0.1

Zero — Zero — — — —

—

F

— — F F — F — F F F

F

F — F — — — —

—

96-12-8

84-74-2 1918-00-9 76-43-6 95-50-1 541-73-1 106-46-7 75-71-8 107-06-2 75-35-4 156-59-2

156-60-5

75-09-2 120-83-2 78-87-5 542-75-6 60-57-1 84-66-2 1445-75-6

70-38-2

MCLG (mg=L)

F

Status Reg.

124-48-1

CASRN Number

Standards

—

0.005 — 0.005 — — — —

0.1

— — 0.06k 0.6 — 0.075 — 0.005 0.007 0.07

0.0002

0.08g

MCL (mg=L)

F 1988

D 1993 D 1994 F 1987 F 1988 F 1988 — F 1989

F 1987

— F 1988 D 1995 F 1987 F 1987 F 1987 F 1989 F 1987 F 1987 F 1990

F 1987

D 1993

Status HA Document

10

10 0.03 — 0.03 0.0005 — 8

20

— 0.3 5 9 9 11 40 0.7 2 4

0.2

6

1-day (mg=L)

10

2 0.03 0.09 0.03 0.0005 — 8

1

— 0.3 5 9 9 11 40 0.7 1 1

0.05

6

10-day (mg=L)

10-kg Child

0.3

0.06 0.003 — 0.03 0.00005 0.8 0.08

0.02

0.1 0.03 0.004 0.09 0.09 0.1 0.2 — 0.009 0.01

—

0.02

RfD (mg=kg=day)

10

2 0.1 — 1 0.002 30 3

0.7

4 1 0.1 3 3 4 5 — 0.3 0.4

—

0.7

DWEL (mg=L)

Health Advisories

2

— — 0.6

— 0.02 —

0.1

— 0.2 — 0.6 0.6 0.075 1 — 0.006 0.07

—

0.06

Lifetime (mg=L)

—

0.5 — 0.06 0.04 0.0002 — —

—

— — —l — — – — 0.04 0.006 —

0.003

0.04

mg=L at 10
4 Cancer Risk

D

B2 E B2 B2 B2 D D

D

D D B2 D D C D B2 C D

B2

C

Cancer Group

603

Dimethyl methylphosphonate Dimethyl phthalate (PAE) Dinitrobenzene (1,3-) Dinitrotoluene (2,4-) Dinitrotoluene (2,6-) Dinitrotoluene (2,6; 2,4)n Dinoseb Dioxane pDiphenamid Diquat Disulfoton Dithiane (1,4-) Diuron Endothall Endrin Epichlorohydrin Ethylbenzene Ethylene dibromide (EDB)r Ethylene glycol Ethylene thiourea (ETU) Fenamiphos Fluometuron Fluorene (PAH) Fonofos Formaldehyde Glyphosate Heptachlor Heptachlor epoxide Hexachlorobenzene Hexachlorobutadienef Hexachlorocyclopentadiene Hexachloroethane Hexane (n-) Hexazinone

—

— — — — — 0.007 — — 0.02 — — — 0.1 0.002 Zero 0.7 Zero

— — — — — — — 0.7 Zero Zero Zero — 0.05

— — —

—

— — — — — F — — F — — — F F F F F

— — — — — — — F F F F — F

— — —

756-79-6

131-11-3 99-65-0 121-14-2 606-20-2

88-85-7 123-91-1 957-51-7 85-00-7 298-04-4 505-29-3 330-54-1 145-73-3 72-20-8 106-89-8 100-41-4 106-933-4

107-21-1 96-45-7 22224-92-6 2164-17-2 86-73-7 944-22-9 50-00-0 1071-83-6 76-44-8 1024-57-3 118-74-1 87-68-3 77-47-4

67-72-1 110-54-3 51235-04-2 — — —

— — — — — — — 0.7 0.0004 0.0002 0.001 — 0.05

— — — — — 0.007 — — 0.02 — — — 0.1 0.002 TTq 0.7 0.00005

— — 1991 1992 1992 1992 1988 1987 1988 — 1988 1992 1988 1988 1987 1987 1987 1987

F 1991 F 1987 F 1996

1987 1988 1988 1988 — F 1988 D 1993 F 1988 F 1987 F 1987 F 1987 D 1998 —

F F F F

F F F F F F F F

F F F F F F F

F 1992

5 10 3

20 0.3 0.009 2 — 0.02 10 20 0.01 0.01 0.05 0.3 —

— 0.04 0.50 0.40 — 0.3 4 0.3 — 0.01 0.4 1 0.8 0.02 0.1 30 0.008

2

5 4 2

6 0.3 0.009 2 — 0.02 5 20 0.01 — 0.05 0.3 —

— 0.04 0.50 0.40 — 0.3 0.4 0.3 — 0.01 0.4 1 0.8 0.005 0.1 3 0.008

2

0.001 — 0.05v

2 0.00008 0.00025 0.01 0.04 0.002 0.2 0.1t 0.0005 0.00001 0.0008 0.0002u 0.006

— 0.0001 0.002 0.001 — 0.001 — 0.03 0.002o 0.00004 0.01 0.002p 0.02 0.0003 0.002 0.1 —

0.2

0.04 — 2

70 0.003 0.009 0.5 1 0.07 7 4 0.02 0.0004 0.03 0.007 0.2

— 0.005 0.1 0.04 — 0.04 — 1 0.07 0.001 0.4 0.07 0.7 0.01 0.07 3 —

7

0.001 — 0.4

14 — 0.002 0.09 — 0.01 1 0.7 — — — 0.001 —

— 0.001 — — — 0.007 — 0.2 — 0.0003 0.08 0.01 0.1 0.002 — 0.7 —

0.1

0.3 — —

D B2 D D D D B1s D B2 B2 B2 C E

D D B2 B2 B2 D B2 D D E D D D D B2 D B2

C

C D D (continued )

— — — — 0.0008 0.0004 0.002 0.05 —

— 0.02 —

— — 0.005 0.005 0.005 — 0.3 — — — — — — — 0.3 — 0.00004

0.7

604

HMXw Indeno[1,2,3-c,d]pyrene (PAH) Isophorone Isoproopyl methylphosphonate Isopropylbenzene (cumene) Lindanex Malathion Maleic hydrazide MCPAy Methomyl Methoxychlor Methyl ethyl ketone Methyl parathion Metolachlor Metribuzin Monochloroacetic acidf Monochlorobenzene Naphthalene Nitrocellulosecc Nitroguanidine Nitrophenol pOxamyl (Vydate) Paraquat

Chemicals

TABLE A.2 (Continued)

— —

— —

—

0.0002 — — — — 0.04 — — — — — 0.1 — — — — 0.2 —

— —

—

F — — — — F — — — — F F — — — — F —

78-59-1 1832-54-8

98-82-8

58-89-9 121-75-5 123-33-1 94-74-6 16752-77-5 72-43-5 78-933-3 298-00-0 51218-45-2 21087-64-9 79-11-8 108-90-7 91-20-3 9004-70-0 556-88-7 100-02-7 23135-22-0 2920-53-6

MCLG (mg=L)

— —

Status Reg.

2691-41-0 193-39-5

CASRN Number

Standards

0.0002 — — — — 0.04 — — — — 0.06k 0.1 — — — — 0.2 —

—

— —

— —

MCL (mg=L)

F F F F F F F

F F F F F F F F F F 1987 1992 1988 1988 1988 1987 1987 1988 1988 1988 — 1987 1990 1988 1990 1992 1987 1988

D 1987

F 1992 F 1992

F 1988 —

Status HA Document

1 0.2 10 0.1 0.3 0.05 75 0.3 2 5 — 4 0.5 — 10 0.8 0.2 0.1

11

15 30

5 —

1-day (mg=L)

1 0.2 10 0.1 0.3 0.05 7.5 0.3 2 5 — 4 0.5 — 10 0.8 0.2 0.1

11

15 30

5 —

10-day (mg=L)

10-kg Child

0.0003 0.02 0.5 0.0005z 0.025 0.005 0.6 0.00025 0.15aa 0.025bb — 0.02 0.02 — 0.1 0.008 0.025dd 0.0045

0.1

0.2 0.1

0.05 —

RfD (mg=kg=day)

0.01 0.8 20 0.02 0.9 0.2 20 0.009 5 0.9 — 0.7 0.7 — 4 0.3 0.9 0.2

4

7 4

2 —

DWEL (mg=L)

Health Advisories

0.0002 0.1 4 0.004 0.2 0.04 4 0.002 0.1 0.2 — 0.1 0.1 — 0.7 0.06 0.2 0.03

—

0.1 0.7

0.4 —

Lifetime (mg=L)

— — — — — — — — — — — — — — — — — —

—

4 —

— —

mg=L at 10
4 Cancer Risk

D C — D D E C

C D D D E D D D C D

D

C D

D B2

Cancer Group

605

Pentachlorophenol Phenanthrene (PAH) Phenol Picloram Polychlorinated biphenyls (PCBs) Prometon Pronamide Propachlor Propazine Propham Pyrene (PAH) RDXff Simazine Styrene 2,4,5-T (Trichlorophenoxyacetic acid) 2,3,7,8-TCCD (dioxin) Tebuthiuron Terbacil Terbufos Tetrachloroethane (1,1,1,2-) Tetrachloroethane (1,1,2,,2-) Tetrachloroethylene Trichlorofluorometahne Toluene Toxaphene 2,4,5-TP (Silvex) Trichloroacetic acidf Trichlorobenzene (1,2,4-) Trichlorobenzene (1,3,5-) Trichloroethane (1,1,1-) Trichloroethane (1,1,2-) Trichloroethylenef Trichlorophenol (2,4,6-)

Zero — — 0.5 Zero

— — — — — — — 0.004 0.1 —

Zero — — — —

—

Zero — 1 Zero 0.05 0.3 0.07 — 0.2 0.003 Zero —

F — — F F

— — — — — — — F F —

F — — — —

—

F — F F F F F — F F F —

87-86-5 85-01-8 108-95-2 1918-02-1 1336-36-3

1610-18-0 23950-58-5 1918-16-7 139-40-2 122-42-9 129-00-0 121-82-4 122-34-9 100-42-5 93-76-5

1746-001-6 34014-18-1 5902-51-2 13071-79-9 620-10-6

79-34-5

127-18-4 75-69-4 108-88-3 8001-35-2 93-72-1 76-03-9 120-82-1 108-70-3 71-55-76 79-00-5 79-01-6 88-06-2 0.005 — 1 0.003 0.05 0.06k 0.07 — 0.2 0.005 0.005 —

1987 1988 1988 1988 1989

1988 1988 1988 1988 1988 — 1988 1988 1987 1988

F 1987 F 1989 D 1993 F 1996 F 1988 D 1996 F 1989 F 1989 F 1987 F 1989 F 1987 D 1994

F 1989

F F F F F

3  10
8 — — — — —

F F F F

F F F F F

F 1987 — D 1992 F 1988 D 1993

— — — — — — — 0.004 0.1 —

0.001 — — 0.5 0.0005

2 7 20 0.004 0.2 4 0.1 0.6 100 0.6 — 0.03

0.04

1  10
6 3 0.3 0.005 2

0.2 0.8 0.5 1 5 — 0.1 0.5 20 0.8

1 — 6 20 —

2 7 2 0.004 0.2 4 0.1 0.6 40 0.4 — 0.03

0.04

1  10
7 3 0.3 0.005 2

0.2 0.8 0.5 1 5 — 0.1 0.5 2 0.8

0.3 — 6 20 —

0.01 0.3 0.2 0.0004 0.008 0.1 0.01 0.006 0.035 0.004 0.007 0.0003

0.00005

1  10
9 0.07 0.01 0.0001 0.03

0.015 0.075 0.01 0.02 0.02 0.03 0.003 0.005 0.2 0.01

0.03 — 0.6 0.07ee —

0.5 10 7 0.01 0.3 4.0 0.4 0.2 1 0.1 0.2 0.01

0.002

4  10
8 2 0.4 0.005 1

0.5 3 0.5 0.7 0.6 — 0.1 0.2 7 0.4

1 — 20 2 —

0.01 2 1 — 0.05 0.3 0.07 0.04 0.2 0.003 — —

0.003

— 0.5 0.09 0.0009 0.07

0.1 0.05 0.09 0.01 0.1 — 0.002 0.004 0.1 0.07

— — 4 0.5 —

— — — 0.003 — — — — — 0.06 0.3 0.3

0.02

2  10
8 — — — 0.1

— — — — — — 0.03 — — —

0.03 — — — 0.01

— D D B2 D C D D D C B2 B2 (continued )

C

B2 D E D C

D C D C D D C C C D

B2 D D D B2

606

Trichloropropane (1,2,3-) Trifluralin Trimethylbenzene (1,2,4-) Trimethylbenzene (1,3,5-) Trinitroglycerol Trinitrotoluene (2,4,6-) Vinyl chloride Xylenes Inorganics Ammonia Antimony Arsenic Asbestos (fibers= L > 10 mm length) Barium Beryllium Boron f Bromate Cadmium Chloramine jj Chlorine Chlorine dioxide Chlorite Chromium (total) Copper (at tap)

Chemicals

TABLE A.2 (Continued)

— — — — — — Zero 10

— 0.006 Zero 7 MFLhh

2 0.004 — Zero 0.005 4kk 4kk 0.8kk 0.8 0.1 1.3

— F F F

F F — F F F F F F F F

7664-41-7 7440-36-0 7440-38-2 1332-21-4

7440-39-3 7440-41-7 7440-42-8 7789-38-0 7440-43-9 10599-90-3 7782-50-5 10049-04-4 7758-19-2 7440-47-3 7440-50-8

MCLG (mg=L)

— — — — — — F F

Status Reg.

96-18-4 1582-09-8 95-63-6 108-67-8 55-63-0 118-96-7 75-01-4 1330-20-7

CASRN Number

Standards

2 0.004 — 0.01 0.005 4kk 4kk 0.8kk 1 0.1 TTmm

— 0.006 0.01 7 MFL

— — — — — — 0.002 10

MCL (mg=L)

D 1993 F 1992 D 1992 D 1998 F 1987 D 1995 D 1995 D 1998 D 1998 F 1987 D 1998

D 1992 F 1992 D 1995 —

F 1989 F 1990 D 1987 D 1987 F 1987 F 1989 F 1987 D 1993

Status HA Document

0.7 30 4 0.2 0.04 1 3 0.84 0.84 1 —

— 0.01 — —

0.6 0.08 — 10 0.005 0.02 3 40

1-day (mg=L)

0.7 30 0.9 — 0.04 1 3 0.84 0.84 1 —

— 0.01 — —

0.6 0.08 — — 0.005 0.02 3 40

10-day (mg=L)

10-kg Child

0.07 0.002 0.09 0.004 0.0005 0.1 0.1 0.03 0.03 0.003ll —

— 0.0004 0.0003 —

0.006 0.0075gg — — — 0.0005 0.003 2

RfD (mg=kg=day)

2 0.07 3 0.14 0.02 3.5 5 1 1 0.1 —

— 0.01 0.01 —

0.2 0.3 — — — 0.02 0.1 70

DWEL (mg=L)

Health Advisories

2 — 0.6 — 0.005 3.0 4 0.8 0.8 — —

30 0.006 — —

0.04 0.005 — — 0.005 0.002 — 10

Lifetime (mg=L)

— — — 0.005 — — — — — — —

— — — 700 MFL

— 0.5 — — 0.2 0.1 0.002 —

mg=L at 10
4 Cancer Risk

D — D B2 D — D D D D D

D D A Aii

— C D D — C A D

Cancer Group

607

Zero Zero

Zero

F F

P

7440-14-4

10043-92-2

Zero

Zero

F

F

0.05 — — 0.0005 — —

F — — F — —

7782-49-2 7440-22-4 74440-24-6 7440-28-0 7723-14-0 7440-66-6

7440-61-1

0.2 4 Zero — 0.002 — — 10 1 10

F F F — F — F F F F

143-33-9 7681-49-4 7439-92-1 7439-96-5 7487-94-7 7439-98-7 7440-02-0 14797-55-8 14797-65-0

300 pCi=L AMCLss 400 pCi=L 30 mg=L

15 pCi=L 5 pCi=L

4 mrem=year

0.05 — — 0.002 — —

0.2 4 TTmm — 0.002 — — 10 1 10

—

— —

—

— F 1992 D 1993 F 1992 F 1990 D 1993

F 1987 — — — F 1987 D 1993 F 1995 D 1993 D 1993 D 1993

—

—

— —

—

— 0.2 25 0.007 — 6

10qq 1qq —

0.2 — — — 0.002 0.08 1

—

—

— —

—

— 0.2 25 0.007 — 6

10qq 1qq —

0.2 — — — 0.002 0.08 1

—

0.1

0.003tt

— —

—

0.2 0.2 20 0.002 0.0005 10

0.8 — — — 0.01 0.2 0.7 – — —

—

— —

—

0.005 0.005rr 0.6 0.00007 0.00002 0.3

0.02nn 0.06oo — 0.14pp 0.0003 0.005 0.02 1.6 0.16 —

—

—

— —

—

0.05 0.1 4 0.0005 0.0001 2

0.2 — — — 0.002 0.04 0.1 – — —

—

150 pCi=L

15 pCi=L —

4 mrem= year

—

— — — —

— — — — — — — – — —

A

A

A A

A

D D D — D D

D — B2 D D D — – — —

a When acrylamide is used in drinking water systems, the combination (or product) of dose and monomer level shall not exceed that equivalent to a polyacrylamide polymer containing 0.05% monomer dosed at 1 mg=L. b Determined not to be carcinogenic at low doses by OPP. c The MCL value for any combination of two or more of these three chemicals should not exceed 0.007 mg=L because of similar mode of action. d Administrative stay of the effective date. e Polycyclic aromatic hydrocarbon. f Under review.

Uranium

Cyanidef Fluoride Lead (at tap) Manganese Mercury (inorganic) Molybdenum Nickel Nitrate (as N) Nitrite (as N) Nitrate þ nitrite (both as N) Selenium Silver Strontium Thallium White phosphorous Zinc Radionuclides Beta particle and photon activity (formerly human-made radionuclides) Gross a-particle activity Combined radium 226 þ 228 Radon

608

h

1998 Final Rule for Disinfectants and Disinfection By-products: The total for trihalomethanes is 0.08 mg=L. Phthalate acid ester. i By the 1999 Draft Guidelines for Carcinogen Risk Assessment, chloroform is likely to be carcinogenic to humans by all routes of exposure under high-dose conditions that lead to cytotoxicity and regenerative hyperplasia in susceptible tissues. Chloroform is not likely to be carcinogenic to humans by all routes of exposures at a dose level that does not cause cytotoxicity and cell regeneration. j New OPP RfD ¼ 0.0003 mg kg
1 day
1. k 1998 Final Rule for Disinfectants and Disinfection By-products: The total for five haloacetic acids is 0.06 mg=L. l A quantitative risk estimate has not been determined. m The values for m-dichlorobenzene are based on data for o-dichlorobenzene. n Technical grade. o New OPP RfD ¼ 0.005 mg kg
1 day
1. p New OPP RfD ¼ 0.003 mg kg
1 day
1. q When e pichlorohydrin is used in drinking water systems, the combination (or product) of dose and monomer level shall not exceed that equivalent to an epichlorohydrinbased polymer containing 0.01% monomer dosed at 20 mg=L. r 1,2-Dibromoethane. s Carcinogenicity based on inhalation exposure. t New OPP RfD ¼ 2 mg kg
1 day
1. u Draft Ambient Water Quality Criteria for the protection of human health (EPA 822-R-98-004). v The Health Advisory is based on a new OPP RfD rather than the IRIS RfD. w HMX ¼ octahydro-1,3,5,7-tetranitro-1,3,5,7-tetrazocine. x Lindane¼ g-hexachlorocyclohexane. y MCPA ¼ 4(chloro-2-methoxyphenoxy)acetic acid. z New OPP RfD ¼ 0.0015 mg kg
1 day
1. aa New OPP RfD ¼ 0.1 mg kg
1 day
1. bb New OPP RfD ¼ 0.013 mg kg
1 day
1. cc The Health Advisory Document for nitrobenzene does not include HA values and describes this compound as relatively non-toxic. dd New OPP RfD ¼ 0.001 mg kg
1 day
1. ee New OPP RfD ¼ 0.2 mg kg
1 day
1. ff RDX ¼ hexahydro-1,3,5-trinitro-1,3,5-triazine (Royal Dutch explosive). gg New OPP RfD ¼ 0.024 mg=kg=day. hh Million fibers per liter.

g

TABLE A.2 (Continued)

609

jj

Carcinogenicity based on inhalation exposure. Monochloramine; measured as free chlorine. kk 1998 Final Rule for Disinfectants and Disinfection By-products: MRDLG ¼ maximum residual disinfection level goal; MRDL ¼ maximum residual disinfection level. ll IRIS value for chromium (VI). mm Copper action level 1.3 mg=L; lead action level 0.015 mg=L. nn This RfD is for hydrogen cyanide. oo Based on dental fluorosis in children, a cosmetic effect; MCLG based on skeletal fluorosis. pp Dietary manganese. qq These values are calculated for a 4-kg infant and are protective for all age groups. rr Based on a cosmetic effect. ss Alternative maximum contaminant level. tt Soluble uranium salts.

ii

610

SUMMARY TABLES OF DRINKING WATER STANDARDS AND

TABLE A.3 Secondary Drinking Water Regulations (Summer 2002) Chemicals Aluminum Chloride Color Copper Corrosivity Fluoride Foaming agents Iron Manganese Odor pH Silver Sulfate Total dissolved solids (TDS) Zinc

CAS Number

Status

SDWR

7429-90-5 7647-14-5 NA 7440-50-8 NA 6781-49-4 NA 74399-89-6 7439-96-5 NA NA 7440-22-4 7757-82-6 NA 7440-66-6

F F F F F F F F F F F F F F F

0.05–0.2 mg=L 250 mg=L 15 color units 1.0 mg=L Noncorrosive 2.0 mg=L 0.5 mg=L 0.3 mg=L 0.05 mg=L 3 threshold odor numbers 6.5–8.5 0.1 mg=L 250 mg=L 500 mg=L 5 mg=L

REFERENCES

611

TABLE A.4 Microbiology (Summer 2002) Status Reg.

Status HA Document

MCLG

MCL

Treatment Technique

Cryptosporidium

F

F 01

—

TT

Giardia lamblia Legionella

F Fa

F 98 F 98

— Zero

TT TT

Heterotrophic plate count (HPC)

Fa

—

NA

TT

Total coliforms

F

—

Zero

5%

Turbidity

F

—

NA

TT

Viruses

Fa

—

Zero

TT

Systems that filter must remove 99% of Cryptosporidium 99.9% killed or inactivated No limit; EPA believes that if Giardia and viruses are inactivated, Legionella will also be controlled No more than 500 bacterial colonies per millilitre No more than 5.0% samples total coliformpositive in a month; every sample that has total coliforms must be analyzed for fecal coliforms; no fecal coliforms are allowed At no time can turbidity go above 5 NTU (nephelometric turbidity units) 99.99% killed or inactivated

a

Final for systems using surface water; also being considered for regulation under groundwater disinfection rule.

612

SUMMARY TABLES OF DRINKING WATER STANDARDS AND

TABLE A.5 Drinking Water Advisory Table (Summer 2002) Chemicals

Status

Health-Based Value

Ammonia Methyl tertiary butyl ether (MtBE) Sodium

D 1992 F 1998

Not available Not available

D 2002

Sulfate

D 2002

20 mg=L (for individuals on a 500-mg=day restricted sodium diet) 500 mg=L

a

Taste Thresholda (mg=L)

Odor Thresholdb

30 40

— 20 (mg=L)

30–60

—

250

—

Taste threshold: concentration at which the majority of consumers do not notice an adverse taste in drinking water; it is recognized that some sensitive individuals may detect a chemical at levels below this threshold. b Odor threshold: concentration at which the majority of consumers do not notice an adverse odor in drinking water; it is recognized that some sensitive individuals may detect a chemical at levels below this threshold.

613

Organics Acrylamide Alachlor Aldicarb Aldicarb sulfone Aldicarb sulfoxide Atrazine Benzene Benzo(a)pyrene Bromodichloromethane Bromoform Carbofuran Carbon tetrachloride Chlordane Chloroform 2,4-D Dalapon Di(2-ethylhexyl)adipate Di(2-ethylhexyl) phthalate Dibromochloromethane Dibromochloropropane (DBCP) Dichloroacetic acid p-Dichlorobenzene o-Dichlorobenzene

Contaminant

Zero Zero 0.001 0.001 0.001 0.003 Zero Zero Zero Zero 0.04 Zero Zero — 0.07 0.2 0.5 Zero 0.06 Zero Zero 0.075 0.6

Final Final Final Final Final

D-DBP Phase II

D-DBP Phase I Phase II

MCLG (mg=L)

Final Final Delayed Delayed Delayed Final Final Final Final Final Final Final Final Final Final Final Final Final

Status

Phase II Phase II Phase II Phase II Phase II Phase II Phase I Phase V D-DBP D-DBP Phase II Phase I Phase II D-DBP Phase II Phase V Phase V Phase V

Reg.

NA 0.075 0.6

NA 0.0002

TT 0.002 0.003 0.002 0.004 0.003 0.005 0.0002 NA NA 0.04 0.005 0.002 NA 0.07 0.2 0.5 0.006

MCL (mg=L)

TABLE A.6 USEPA Drinking Water Standards and BAT for Regulated Contaminantsa

EC GAC; PTA GAC; PTA

EC GAC; PTA

PAP GAC GAC GAC GAC GAC GAC; PTA GAC EC EC GAC GAC; PTA GAC EC GAC GAC GAC; PTA GAC

BAT

(1991a) (1991a) (1992a) (1992a) (1992a) (1991a) (1987) (1992b) (1998a) (1998a) (1991a) (1987) (1991a) (1998a) (1991a) (1992b) (1992b) (1992b)

USEPA (1998a) USEPA (1987) USEPA (1991a) (continued )

USEPA (1998a) USEPA (1991a)

USEPA USEPA USEPA USEPA USEPA USEPA USEPA USEPA USEPA USEPA USEPA USEPA USEPA USEPA USEPA USEPA USEPA USEPA

Reference

614

1,2-Dichloroethane 1,1-Dichloroethylene cis-1,2-Dichloroethylene trans-1,2-Dichloroethylene Dichloromethane (methylene chloride) 1,2-Dichloropropane Dinoseb Diquat Endothall Endrin Epichlorohydrin Ethylbenzene Ethylene dibromide (EDB) Glyphosphate Haloacetic acids (sum of 5; HAA5)b Heptachlor Heptachlor epoxide Hexachlorobenzene Hexachloroocyclopentadiene Lindane

Contaminant

TABLE A.6 (Continued)

Zero 0.007 0.07 0.1 Zero Zero 0.007 0.02 0.1 0.002 Zero 0.7 Zero 0.7 — Zero Zero Zero 0.05 0.0002

Final Final Final Final Final Final Final Final Final Final Final Final Final Final Final Final Final

Phase II

Phase V

II V V V V II II II

Phase V D-DBP

II II V V

Phase Phase Phase Phase Phase Phase Phase Phase

Phase Phase Phase Phase

Phase II

MCLG (mg=L)

Final Final Final

Status

Phase I Phase I Phase II

Reg.

0.0002

0.0004 0.0002 0.001 0.05

0.7 0.060

0.005 0.007 0.02 0.1 0.002 TT 0.7 0.00005

0.005

0.1

0.005 0.007 0.07

MCL (mg=L)

USEPA (1992b) USEPA USEPA USEPA USEPA USEPA USEPA USEPA USEPA

PTA GAC; PTA GAC GAC GAC GAC PAP GAC; PTA GAC; PTA

USEPA USEPA USEPA USEPA

USEPA (1991a)

GAC

(1991a) (1991a) (1992b) (1992b)

USEPA (1992b) USEPA (1998a) GAC GAC GAC GAC; PTA

OX EC

USEPA (1991a)

GAC; PTA

(1991a) (1992b) (1992b) (1992b) (1992b) (1991a) (1991a) (1991a)

USEPA (1987) USEPA (1987) USEPA (1991a)

Reference

GAC; PTA GAC; PTA GAC; PTA

BAT

615

Asbestos (fibers=L > 10 mm)

Inorganics Antimony Arsenic

Methoxychlor Monochlorobenzene Oxamyl(vydate) Pentachlorophenol Picloram Polychlorinated biphenyls (PCBs) Simazine Styrene 2,3,7,8-TDD (dioxin) Tetrachloroethylene Toluene Toxaphene 2,4,5-TP (Silvex) Trichloroacetic acid 1,2,4-Trichlorobenzene 1,1,1-Trichloroethane 1,1,2-Trichloroethane Trichloroethylene Trihalomethanes (sum of 4; TTHMs)c Vinyl chloride Xylenes (total)

0.006 Zero 7 MFL

Final

Phase II

Zero 10

Final Final

Phase I Phase II

Final Final

0.004 0.1 Zero Zero 1 Zero 0.05 0.3 0.07 0.2 0.003 Zero NA

Final Final Final Final Final Final Final Final Final Final Final Final Final

Phase V Phase II Phase V Phase II Phase II Phase II Phase II D-DBP Phase V Phase I Phase V Phase I D-DBP

Phase V Arsenic

0.04 0.1 0.2 Zero 0.5 Zero

Final Final Final Final Final Final

II II V II V II

Phase Phase Phase Phase Phase Phase

7 MFL

0.006 0.01

0.002 10

0.004 0.1 5  10
8 0.005 1 0.005 0.05 NA 0.07 0.2 0.005 0.005 0.080

0.04 0.1 0.2 0.001 0.5 0.0005

CF;d RO IX; AA; RO; CF; LS; EDR CF;d DF; DEF; CC; IX; RO

PTA GAC; PTA

GAC GAC; PTA GAC GAC; PTA GAC; PTA GAC GAC EC GAC; PTA GAC; PTA GAC; PTA GAC; PTA AD; PR; SPC; EC

GAC GAC; PTA GAC GAC GAC GAC (1991a) (1991a) (1992b) (1992a) (1992b) (1991a)

(continued )

USEPA (1991a)

USEPA (1992b) USEPA (2001)

USEPA (1987) USEPA (1991)

USEPA (1992b) USEPA (1991a) USEPA (1992b) USEPA (1991a) USEPA (1991a) UEPA (1991a) USEPA (1991) USEPA (1998a) USEPA (1992b) USEPA (1987) USEPA (1992b) USEPA (1987) USEPA (1998a)

USEPA USEPA USEPA USEPA USEPA USEPA

616

Radionuclides b-Particle and photon emitters

Rads

Phase V

Thallium

Final

Zero

0.0005

0.05

Final

Phase II Final

10

0.1 10

Final Final Final Final

2 Zero Zero 0.005 0.8 0.1 1.3 0.2 4 Zero 0.002

MCLG (mg=L)

V II II II

Phase Phase Phase Phase

Final Final Final Final Final Final Final Final Final Final Final

Status

Nickel Nitrate (as N) Nitrite (as N) Nitrate þ nitrite (both as N) Selenium

Phase II Phase V D-DBP Phase II D-DBP Phase II LCR Phase V Fluoride LCR Phase II

Reg.

Barium Beryllium Bromate Cadmium Chlorite Chromium (total) Copper Cyanide Fluoride Lead Mercury

Contaminant

TABLE A.6 (Continued)

4 mrem

0.002

0.05

0.1 10 1 10

2 0.001 0.010 0.005 1.0 0.1 TT 0.2 4 TT 0.002

MCL (mg=L)

IX; RO

CF [Se(IV)];d LS;d AA; RO; ED IX; AA

LS;d IX; RO AA; IX; RO; LS;d DC CF;d AAA; IX; RO DC CF;d LS [Cr(III)];d IX; RO CC; SWT CL; IX; RO AA; RO CC; PE; SWT; LSLR CF (influent  10 mg=L);d RO;d GAC; LSd (influent  10 mg=L) LS;d IX; RO IX; LS;d RO ED; IX; RO IX; RO IX; RO

BAT

(1992b) (1991a) (1991a) (1991a)

USEPA USEPA USEPA USEPA

USEPA (2000)

USEPA (1992b)

USEPA (1991a)

(1992a) (1992b) (1998a) (1991a) (1998a) (1991a) (1991b) (1992b) (1986) (1991b) (1991a)

USEPA USEPA USEPA USEPA USEPA USEPA USEPA USEPA USEPA USEPA USEPA

Reference

617

R

Uranium

SWTR

E. coli Fecal coliforms Giardia lamblia Heterotrophic bacteria Legionella Total coliforms Turbidity

Viruses

Zero Zero Zero — Zero Zero — Zero

Finale

Zero

Zero

Zero Zero Zero

Final Final Final Finale Finale Final Final

Final

Final

Final Final Proposed

TT

— TT TT TT TT —f PS

TT

15 pCi=L 5 pCi=L 300 pCi=L AMCL: 4000 pCi=L 30 mg=L

SSF; DEF; DF; D

SSF; DEF; DF; D SSF; DEF; DF; D SSF; DEF; DF; D

CF; SSF; DEF; DF; D

D D CF; CF; CF; D CF;

USEPA (1998b, 2002) USEPA (1989b) USEPA (1989b) USEPA (1989a) USEPA (1989a) USEPA (1989a) USEPA (1989b) USEPA (1998b, 2002) USEPA (1989a)

USEPA (2000)

LS; AX; EC; RO

CF; SSF; DEF; DF; D

USEPA (2000) USEPA (2000) USEPA (1999)

RO LS;d IX; RO AR

a Key: AA ¼ activated alumina; AD ¼ alternative disinfectants; AR ¼ aeration; AX ¼ anion exchange; CC ¼ corrosion control; CF ¼ coagulation and filtration; Cl2 ¼ chlorination; D ¼ disinfection; DC ¼ disinfection system control; DEF ¼ diatomaceous earth filtration; DF ¼ direct filtration; EC ¼ enhanced coagulation; ED ¼ electrodialysis; EDR ¼ electrodialysis reversal; GAC ¼ granular activated carbon; IX ¼ ion exchange; LS ¼ lime softening; LSLR ¼ lead service line replacement; NA ¼ not applicable; OX ¼ oxidation; PAP ¼ polymer addition practices; PE ¼ public education; PR ¼ precursor removal; PS ¼ performance standard; PTA ¼ packedtower aeration; RO ¼ reverse osmosis; SPC ¼ stop prechlorination; SWT ¼ source water treatment; TT ¼ treatment technique. b Sum of the concentrations of mono-, di-, and trichloroacetic acids and mono- and dibromoacetic acids. c Sum of the concentrations of bromodichloromethane, dibromochloromethane, bromoform, and chloroform. d Coagulation–filtration and lime softening are not BAT for small systems for variances unless treatment is already installed. e Final for systems using surface water; also being considered for groundwater systems. f No more than 5% of the samples per month may be positive. For systems collecting fewer than 40 samples per month, no more than 1 sample per month may be positive.

IESWTR and LT1ESWTR TCR TCR SWTR SWTR SWTR TCR SWTR

Microbials Cryptosporidium

Rads Rads Radon

Alpha emitters Radium 226 þ 228 Radon

618

SUMMARY TABLES OF DRINKING WATER STANDARDS AND

TABLE A.7 USEPA National Secondary Drinking Water Contaminant Standards Contaminanta Aluminum Chloride Color Copper Corrosivity Fluoride Foaming agents Iron

Manganese Odor þ pH

Silver Sulfate Total dissolved solids Zinc a

Effects

SMCL (mg=L)

Reference

Colored water Salty taste Visible tint Metallic taste, blue-green stain Metallic taste, corrosion, fixture staining Tooth discoloration Frothy, cloudy, bitter taste, odor Rusty color, sediment, metallic taste, reddish or orange staining Black to brown color, black staining, bitter metallic taste ‘‘Rotten egg,’’ musty, or chemical smell Low pH—bitter metallic taste, corrosion High pH—slippery feel, soda taste, deposits Skin discoloration, graying of the white of the eye Salty taste Hardness; deposits; colored water; staining; salty taste Metallic taste

0.05–0.2 250 15 color units 1.0 Noncorrosive

USEPA USEPA USEPA USEPA USEPA

2 0.5 0.3

USEPA (1986) USEPA (1979) USEPA (1979)

0.05

USEPA (1979)

3 TONb

USEPA (1979)

6.5–8.5

USEPA (1979)

0.10

USEPA (1991)

250 500

USEPA (1979) USEPA (1979)

5

USEPA (1979)

(1991) (1979) (1979) (1979) (1979)

Although no secondary maximum contaminant level (SMCL) has been set, tastes and odors may be caused by the following organic chemicals at the levels indicated: o-dichlorobenzene—0.01 mg=L, p-dichlorobenzene—0.005 mg=L, ethylbenzene—0.03 mg=L, pentachlorophenol—0.03 mg=L, styrene— 0.01 mg=L, toluene—0.04 mg=L, and xylene—0.02 mg=L. These levels are below the MCLs for these contaminants, meaning that consumers may taste or smell them even though the MCLs are met.

REFERENCES

TABLE A.8 Total Coliform Monitoring Frequency for Community Water Systems Population Served 25–1000a 1001–2500 2501–3300 3301–4100 4101–4900 4901–5800 5801–6700 6701–7600 7601–8500 8501–12,900 12,901–17,200 17,201–21,500 21,501–25,000 25,001–33,000 33,001–41,000 41,001–50,000 50,001–59,000 59,001–70,000 70,001–83,000 83,001–96,000 96,001–130,000 130,001–220,000 220,001–320,000 320,001–450,000 450,001–600,000 600,001–780,000 780,001–970,000 970,001–1,230,000 1,230,001–1,520,000 1,520,000–1,850,000 1,850,001–2,270,000 2,270,001–3,020,000 3,020,001–3,960,000  3,960,001 a

Minimum Samples per Month 1 2 3 4 5 6 7 8 9 10 15 20 25 30 40 50 60 70 80 90 100 120 150 180 210 240 270 300 330 360 390 420 450 480

Includes public water systems that have at least 15 service connections, but serve fewer than 25 persons. Source: USEPA (1989b).

619

Appendix B 1962 U.S. PUBLIC HEALTH SERVICE STANDARDS

Adoption of the 1962 U.S. Public Health Service standards was completed by publication in the Federal Register, March 6, 1962 (pp. 2152–2155). The full text of these standards is provided below.

PREFACE BY THE ADVISORY COMMITTEE Domestic water supplies should protect the health and promote the well-being of individuals and the community. In this report on the revision of the 1946 edition of the USPHS drinking water standards, the objective of the committee is to recommend minimum requirements for reaching these goals. The USPHS drinking water standards were first adopted in 1914 to protect the health of the traveling public. The general and widespread use of these standards since that time has led to a series of revisions that have been applicable to water supplies generally. The development of atomic energy and other technological advances require that these standards again be revised. To carry out this revision, the chief sanitary engineer of USPHS appointed the undersigned advisory committee. A technical subcommittee of USPHS officers and a toxicological task force were established to collect information and prepare suggestions for the consideration of the advisory committee. In preparing this report on the revision of the standards, the committee established the following guidelines: 1. The proposed standards should be discussed widely, and due cognizance should be given to international and other standards of water quality before a final report is submitted. Drinking Water Regulation and Health, Edited by Frederick W. Pontius. ISBN 0-471-41554-5 # 2003 John Wiley & Sons, Inc.

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2. A new section on radioactivity should be added. 3. Greater attention should be given to the chemical substances being encountered increasingly, in both variety and quantity, in water sources. 4. In establishing limits for toxic substances, intake from food and air should be considered. 5. The rationale employed in determining the various limits should be included in an appendix. 6. The proposed format, with the exceptions noted above, should not differ greatly from the present standards. 7. The standards should be generally acceptable and should be applicable to all public water supplies in the United States, as well as to those supplies used by carriers subject to USPHS regulations. 8. The following two types of limits used in previous editions should be continued: a. Limits that, if exceeded, shall be grounds for rejection of the supply. Substances in this category may have adverse effects on health when present in concentrations above the limit. b. Limits that should not be exceeded whenever more suitable supplies are, or can be made, available at reasonable cost. Substances in this category, when present in concentrations above the limit are either objectionable to an appreciable number of people or exceed the levels required by good water quality control practices. 9. These limits should apply to the water at the free-flowing outlet of the ultimate consumer. This revision of the drinking water standards includes, for the first time, limiting concentrations of radioactivity in water. The effects on large population groups of chronic exposure to low levels of radioactivity are not yet well defined. The limits presented herein are an effort to derive conservative values from the best information now available and may be adjusted upward or downward as new and better data become available. The committee has taken cognizance of the growing problem of potentially harmful chemicals in sources of drinking water. Limits for several new chemicals have been added, including a gross limit for the concentration of some types of synthetic chemicals. It was not feasible, however, to include limits for all the many chemicals that have varying degrees of toxic potential. Consideration was given to the more common chlorinated hydrocarbon and organophosphate insecticides, but the information available was not sufficient to establish specific limits for these chemicals. Moreover, the concentrations of these chemicals, where tested, have been below those that would constitute a known health hazard. The committee believes that pollution of water supplies with such contaminants can become significant and urges that the problem be kept under closer surveillance. Further, the committee recommends that regulatory actions be taken to minimize concentrations of such chemicals in drinking water.

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In view of the accelerating pace of new developments affecting water quality, the committee recommends that a mechanism be established for continual appraisal and appropriate revision of the standards. It also recommends that USPHS intensify its continuing studies toward the development of basic information on the relationship of the biological, chemical, physical, and radiological aspects of water quality to health. Membership of the Advisory Committee U.S. Public Health Service: O. C. Hopkins, Chairman U.S. Public Health Service: George W. Burke, Jr., Secretary Federal Food and Drug Administration: L. M. Beacham, Jr. U.S. Geological Survey: S. K. Love Air Transport Association of America: K. L. Stratton American Chemical Society: T. E. Larson American Dental Association: Robert A. Downs American Medical Association: W. D. Stovall American Public Health Association: Daniel A. Okun American Society of Civil Engineers: Thomas R. Camp American Water Works Association: Oscar Gullans Association of American Railroads: R. S. Glynn Association of State and Territorial Public Health Laboratory Directors: F. R. Hassler Conference of State Sanitary Engineers: E. C. Jensen National Committee on Radiation Protection: John B. Hursh Society of American Bacteriologists: Charles C. Croft Water Pollution Control Federation: F. W. Gilcreas Member at Large: Henry J. Ongerth Technical Subcommittee, Officers of the USPHS George W. Burke, Jr M. B. Ettinger Malcolm Hope O. C. Hopkins, Cochairman Paul Kabler H. G. Magnuson H. E. Stokinger Floyd Taylor

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James G. Terrill Richard Woodward, Cochairman Task Force on Toxicology Kenneth P. DuBois Harvey Haag Wayland J. Hayes, Jr. Harry Hays Arnold J. Lehman H. E. Stokinger Drinking Water Standards 1. Definition of Terms The terms used in these standards are as follows: 1.1. Adequate protection by natural means involves one or more of the following processes of nature that produce water consistently meeting the requirements of these standards: dilution, storage, sedimentation, sunlight, aeration, and the associated physical and biological processes that tend to accomplish natural purification in surface waters and, in the case of groundwaters, the natural purification of water by infiltration through soil and percolation through underlying material and storage below the ground water table. 1.2. Adequate protection by treatment is anyone or any combination of the controlled processes of coagulation, sedimentation, sorption, filtration, disinfection, or other processes that produce a water consistently meeting the requirements of these standards. This protection also includes processes that are appropriate to the source of supply; works that are located, designed, and constructed to eliminate or prevent pollution; and conscientious operation by well-trained and competent personnel whose qualifications are commensurate with the responsibilities of the position and acceptable to the reporting agency and the certifying authority. 1.3. Certifying authority is the surgeon general of USPHS or his duly authorized representatives. (Reference to the certifying authority is applicable only for those water supplies to be certified for use on carriers subject to the USPHS regulations—42 CFR Part 72.) 1.4. The coliform group includes all organisms considered in the coliform group as set forth in Standard Methods for the Examination of Water and Wastewater, current edition [11th ed., 1960], prepared and published jointly by the American Public Health Association, American Water Works Association, and Water Pollution Control Federation.

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1.5. Health hazards are conditions, devices, or practices in the water supply system and its operation that create, or may create, a danger to the health and well-being of the water consumer. An example of a health hazard is a structural defect on the water supply system, whether of location, design, or construction, that may regularly or occasionally prevent satisfactory purification of the water supply or cause it to be polluted from extraneous sources. 1.6. Pollution, as used in these standards, is defined as the presence of any foreign substance (organic, inorganic, radiological, or biological) in water which tends to degrade its quality so as to constitute a hazard or impair the usefulness of the water. 1.7. Reporting agencies are the respective official state health agencies or their designated representatives. 1.8. The standard sample for the bacteriological test shall consist of 1.81. For the bacteriological fermentation tube test, five standard portions of either: (a) 10 mL or (b) 100 mL 1.82. For the membrane filter technique, not less than 50 mL 1.9. Water supply system includes the works and auxiliaries for collection, treatment, storage, and distribution of the water from the sources of supply to the free-flowing outlet of the ultimate consumer. 2. Source and Protection 2.1. The water supply should be obtained from the most desirable source feasible, and effort should be made to prevent or control pollution of the source. If the source is not adequately protected by natural means, the supply shall be adequately protected by treatment. 2.2. Frequent sanitary surveys shall be made of the water supply system to locate and identify health hazards that might exist in the system. The manner and frequency of making these surveys, and the rate at which discovered health hazards are to be removed, shall be in accordance with a program approved by the reporting agency and the certifying authority. 2.3. Approval of water supplies shall be dependent in part on a. Enforcement of rules and regulations to prevent development of health hazards b. Adequate protection of the water quality throughout all parts of the system, as demonstrated by frequent surveys c. Proper operation of the water supply system under the responsible charge of personnel whose qualifications are acceptable to the reporting agency and the certifying authority

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d. Adequate capacity to meet peak demands without development of low pressures or other health hazards e. Record of laboratory examinations showing consistent compliance with the water quality requirements of these standards 2.4. For the purpose of application of these standards, responsibility for the conditions in the water supply system shall be considered to be held by a. The water purveyor, from the source of supply to the connection to the customer’s service piping. b. The owner of the property served and the municipal, county, or other authority having legal jurisdiction, from the point of connection to the customer’s service piping to the free-flowing outlet of the ultimate consumer. 3. Bacteriological Quality 3.1. Sampling 3.1.1. Compliance with the bacteriological requirements of these standards shall be based on examinations of samples collected at representative points throughout the distribution system. The frequency of sampling and the location of sampling points shall be established jointly by the reporting agency and the certifying authority after investigation by either agency, or both, of the source, method of treatment, and protection of the water concerned. 3.1.2. The minimum number of samples to be collected from the distribution system and examined each month should be in accordance with the number in Fig. B.1 for the population served by the system. For the purpose of uniformity and simplicity in application, the number determined from Fig. B.1 should be in accordance with the following: for a population of 25,000 or less, to the nearest 1; 25,001–100,000, to the nearest 5: and more than 100,000 to the nearest 10. 3.1.3. In determining the number of samples examined monthly, the following samples may be included, provided all results are assembled and available for inspection, and the laboratory methods and technical competence of the laboratory personnel are approved by the reporting agency and the certifying authority: a. b. c. d.

Samples examined by the reporting agency Samples examined by local government laboratories Samples examined by the water works authority Samples examined by commercial laboratories.

3.1.4. The laboratories in which these examinations are made and the methods used in making them shall be subject to inspection at any time by the designated representatives of the certifying authority and the reporting agency. Compliance

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Figure B.1 Relation between minimum number of samples to be collected per month and population served.

with the specified procedures and the results obtained shall be used as a basis for certification of the supply. 3.1.5. Daily samples collected following a bacteriologically unsatisfactory sample as provided in Secs. 3.21, 3.22, and 3.23 shall be considered as special samples and shall not be included in the total number of samples examined. Neither shall such special samples be used as a basis for prohibiting the supply, provided that 1. When waters of unknown quality are being examined, simultaneous tests are made on multiple portions of a geometric series to determine a definitive coliform content. 2. Immediate and active efforts are made to locate the cause of pollution. 3. Immediate action is taken to eliminate the cause. 4. Samples taken following such remedial action are satisfactory.

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3.2. Limits. The presence of organisms of the coliform group as indicated by samples examined shall not exceed the following limits: 3.2.1. When 10-mL standard portions are examined, not more than 10% in any month shall show the presence of the coliform group. The presence of the coliform group in three or more 10-mL portions of a standard sample shall not be allowable if this occurs a. In two consecutive samples. b. In more than one sample per month when less than twenty are examined per month. c. In more than 5 per cent of the samples when twenty or more are examined per month. When organisms of the coliform group occur in three or more of the 10-mL portions of a single standard sample, daily samples from the same sampling point shall be collected promptly and examined until the results obtained from at least two consecutive samples show the water to be of satisfactory quality. 3.2.2. When 100-mL standard portions are examined, not more than 60% in any month shall show the presence of the coliform group. The presence of the coliform group in all five of the 100-mL portions of a standard sample shall not be allowable if this occurs: a. In two consecutive samples. b. In more than one sample per month when less than five are examined per month. c. In more than 20 percent of the samples when five or more are examined per month. When organisms of the coliform group occur in all five of the 100-mL portions of a single standard sample, daily samples from the same sampling point shall be collected promptly and examined until the results obtained from at least two consecutive samples show the water to be of satisfactory quality. 3.2.3. When the membrane filter technique is used, the arithmetic mean coliform density of 0 standard samples examined per month shall not exceed 1 per 100 mL. Coliform colonies per standard sample shall not exceed 3 per 50 ml, 4 per 100 mL, 7 per 200 mL, or 13 per 500 mL in a. Two consecutive samples. b. More than one standard sample when less than 20 are examined per month. c. More than 5% of the standard samples when 20 or more are examined per month.

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When coliform colonies in a single standard sample exceed the above values, daily samples from the same sampling point shall be collected promptly and examined until the results obtained from at least two consecutive samples show the water to be of satisfactory quality. 4. Physical Characteristics 4.1. Sampling. The frequency and manner of sampling shall be determined by the reporting agency and the certifying authority. Under normal circumstances, samples should be collected one or more times per week from representative points in the distribution system and examined for turbidity, color, threshold odor, and taste. 4.2. Limits. Drinking water should contain no impurity that would cause offense to the sense of sight, taste, or smell. Under general use, the following limits should not be exceeded: turbidity, 5 units; color, 15 units; and threshold odor number, 3 units. 5. Chemical Characteristics 5.1. Sampling. The frequency and manner of sampling shall be determined by the reporting agency and the certifying authority. Under normal circumstances, analyses for substances listed below need be made only semiannually. If, however, there is some presumption of unfitness because of the presence of undesirable elements, compounds, or materials, periodic determinations for the suspected toxicant or material should be made more frequently, and an exhaustive sanitary survey should be made to determine the source of the pollution. Where the concentration of a substance is not expected to increase in processing and distribution, available and acceptable source water analyses performed in accordance with standard methods may be used as evidence of compliance with these standards. Where experience, examination, and available evidence indicate that particular substances are consistently absent from a water supply or below levels of concern, semiannual examinations for those substances may be omitted when approved by the reporting agency and the certifying authority. The burden of analysis may be reduced in many cases by using data from acceptable sources. Judgment concerning the quality of water supply and the need for performing specific local analyses may depend in part on information produced by such agencies as (1) USGS, which determines chemical quality of surface water and groundwater of the United States and publishes these data in Water Supply Papers and other reports, and (2) USPHS, which determines water quality related to pollution (or the absence of pollution) in the principal rivers of the United States and publishes these data annually in National Water Quality Network. Data on pollution of waters as measured by carbon chloroform extracts (CCES) may be found in the latter publication. 5.2. Limits. Drinking water shall not contain impurities in concentrations that may be hazardous to the health of the consumers. It should not be excessively corrosive to the water supply system. Substances used in its treatment shall not remain in the

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TABLE B.1 A Water Supply with Concentrations Exceeding These Limits Should Be Avoided If Possiblea Substance

Alkyl benzene sulfonate (ABS) Arsenic (As) Chloride (Cl) Copper (Cu) Carbon Chloroform extract (CCE) Cyanide (CN) Fluoride (F) Iron (Fe) Manganese (Mn) Nitrate (NO3)c Phenols Sulfate (SO4) Zinc (Zn)

Concentration (mg=L) 0.5 0.01 250.0 1.0 0.2 0.01 —b 0.3 0.05 45.0 0.001 250.0 5.0

a

Refer to Section 5.2.1 (in this Appendix). See Section 5.2.3. c In areas in which the nitrate content of water is known to be in excess of the listed concentration, the public should be warned of the potential dangers of using the water for infant feeding. b

water in concentrations greater than required by good practice. Substances that may have deleterious physiological effect, or substances for which physiological effects are not known, shall not be introduced into the system in a manner that would permit them to reach the consumer. 5.2.1. The chemical substances shown in Table B.1 should not be present in a water supply in excess of the listed concentrations where, in the judgment of the reporting agency and the certifying authority, other more suitable supplies are or can be made available. 5.2.2. The presence of substances in excess of the concentrations listed in Table B.2 shall constitute grounds for rejection of the supply. 5.2.3. Fluoride. When fluoride is naturally present in drinking water, the concentration should not average more than the appropriate upper limit shown in Table B.3. Presence of fluoride in average concentrations greater than two times the optimum values in Table B.3 shall constitute grounds for rejection of the supply. Where fluoridation (supplementation of fluoride in drinking water) is practiced, the average fluoride concentration shall be kept within the upper and lower control limits shown in Table B.3. In addition to the sampling required by Sec. 5.1, fluoridated and defluoridated supplies shall be sampled with sufficient frequency to determine that the desired fluoride concentration is maintained.

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Table B.2 A Water Supply with Concentrations Exceeding These Limits Should Be Rejecteda Substance

Concentration (mg=L)

Arsenic (As) Barium (Ba) Cadmium (Cd) Chromium (Cr6þ ) Cyanide (CN) Fluoride (F) Lead (Pb) Selenium (Se) Silver (Ag) a b

0.05 1.0 0.01 0.05 0.2 —b 0.05 0.01 0.05

Refer to Section 5.2.2. See Section 5.2.3.

6. Radioactivity 6.1. Sampling. The frequency of sampling and analysis for radioactivity shall be determined by the reporting agency and the certifying authority after consideration of the likelihood of significant amounts being present. Where concentrations of 226 Ra or 90 Sr may vary considerably, quarterly samples composited over a period of 3 months are recommended. Samples for determination of gross activity should be taken and analyzed more frequently. As indicated in Sec. 5.1, data from acceptable sources may be used to indicate compliance with these requirements. 6.2. Limits 6.2.1. The effects of human radiation exposure are viewed as harmful and any unnecessary exposure to ionizing radiation should be avoided. Approval of water supplies containing radioactive materials shall be based on the judgment that the Table B.3 Recommended Fluoride Control Limits a Annual Average of Maximum Daily Air Temperature b ,
F 50.0–53.7 53.8–58.3 58.4–63.8 63.9–70.6 70.7–79.2 79.3–90.5 a b

Recommended Control Limits for Fluoride Concentration, mg=L Lower

Optimum

Upper

0.9 0.8 0.8 0.7 0.7 0.6

1.2 1.1 1.0 0.9 0.8 0.7

1.7 1.5 1.3 1.2 1.0 0.8

Refer to Section 5.2.3. Based on temperature data obtained for a minimum of 5 years.

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radioactivity intake from such water supplies when added to that from all other sources will not result in an intake greater than the radiation protection guidance recommended by the Federal Radiation Council and approved by the President. Water supplies shall be approved without further consideration of other sources of radioactivity intake of 226 Ra and 90 Sr when the water contains these substances in amounts not exceeding 3 and 10 mmCi=L, respectively. When these concentrations are exceeded, a water supply shall be approved by the certifying authority if surveillance of total intakes of radioactivity from all sources indicates that such intakes are within the limits recommended by the Federal Radiation Council for control action. The Federal Radiation Council, in its Memorandum for the President, Sept. 13, 1961, recommended that ‘‘routine control of useful applications of radiation and atomic energy should be such that expected average exposures of suitable samples of an exposed population group will not exceed the upper value of Range II (20 mmCi=day of 226 Ra and 200 mmCi=day of 90 Sr). 6.2.2. In the known absence* of 90 Sr and alpha emitters, the water supply is acceptable when the gross beta concentrations do not exceed 1000 mmCi=L. Gross beta concentrations in excess of 1000 mmCi=L shall be grounds for rejection of supply except when more complete analyses indicate that concentrations of nuclides are not likely to cause exposures greater than the Radiation Protection Guides as approved by the President on recommendation of the Federal Radiation Council. 7. Recommended Analytical Methods 7.1. Analytical methods to determine compliance with the requirements of these standards shall be those specified in Standard Methods for the Examination of Water and Wastewater, APHA, AWWA, and WPCF, New York, current edition [11th ed., 1960], and those specified as follows: 7.2. Barium. Rainwater, F. H., and L. L. Thatcher: Methods for the Collection and Analysis of Water Samples, USGS, Water Supply Papers, 1454, Govt. Printing Office, Washington, DC. 7.3. Carbon Chloroform Extract (CCE). Method for Determining the Carbon Chloroform Extract (CCE) in Drinking Water, R. A. Taft San. Eng. Center, USPHS, Cincinnati (1961). 7.4. Radioactivity. Laboratory Manual of Methodology; Radionuclide Analysis of Environmental Samples, Tech. Rept. R59-6, R. A. Taft San. Eng. Center, USPHS, Cincinnati; and Methods of Radiochemical Analysis, Tech. Rept. 173, Joint WHOFAO Committee, World Health Organization (1959). *Absence is taken here to mean a negligibly small fraction of the above specific limits where the limit for the unidentified alpha emitters is taken as the listed limit for 226 Ra.

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7.5. Selenium. Magin, C. B., et al: Suggested Modified Method for Colorimetric Determination of Selenium in Natural Water, J. Am. Water Workd Assoc. 52:119 (Sept. 1960). 7.6. Organisms of the Coliform Group. All of the details of techniques in the determination of bacteria of this group, including the selection and preparation of apparatus and media, the collection and handling of samples, and the intervals and conditions of storage allowable between collection and examination of the water sample, shall be in accordance with Standard Methods for the Examination of Water and Wastewater, current edition, and the procedures shall be those specified therein for 7.6.1. Membrane Filter Technique, standard test, or 7.6.2. Completed Test, or 7.6.3. Confirmed Test, procedure with brilliant green lactose bile broth. 7.6.4. Confirmed Test, procedure with Endo or eosin methylene blue agar plates.*

*The Confirmed Test is allowed, provided the value of this test to determine the sanitary quality of the specific water supply being examined is established beyond reasonable doubt by comparisons with Completed Tests performed on the same water supply.

APPENDIX C SECTION-BY-SECTION SUMMARY OF THE SDWA FREDERICK W. PONTIUS, P.E. Pontius Water Consultants, Inc. Lakewood, Colorado

The Safe Drinking Water Act (SDWA) is the common name of Title XIV of the US Public Health Service Act. It was enacted in 1974 and amended in 1977, 1979, 1980, 1986, 1988, and most recently in 1996. Congress amended most of the original act and added six new sections in 1986. Subpart F was added in 1988 with the passage of the Lead Contamination Control Act. Substantial revisions and 11 new sections were added by the SDWA amendments of 1996. In addition to revising the SDWA, the 1996 amendments contained other provisions summarized at the end of this Appendix. Sections 1433, 1434, and 1435 were added by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, which also made several amendments to other provisions of the Act. The provisions of each section of the SDWA are reviewed in this Appendix (beginning on the next page) and appear in 42 United States Code 300f–300j–ll. The complete act, as amended, is included as Appendix D.

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Outline Section 1400—Short Title Part A—Definitions Section 1401—Definitions

Part B—Public Water Systems Section 1411—Coverage Section 1412—National Primary Drinking Water Regulations National Primary Drinking Water Regulations 1986 SDWA Amendments 1996 SDWA Amendments Identification of Unregulated Contaminants for Listing Determination to Regulate Regulatory Priorities Urgent Threats to Public Health Regulation Deadlines Health Advisories and Other Actions Risk Assessment, Management, and Communication Use of Science in Decision Making Public Information on Health Effects Health Risk Reduction and Cost Analysis MCLGs and MCLs Feasible Technologies List of Technologies for Small Systems List of Technologies that Achieve Compliance Listing of Additional Technologies Technologies that Meet the Surface Water Treatment Rule Additional Health Risk Considerations Additional Health Risk Reduction and Cost Considerations Treatment Technique Mandatory Filtration Mandatory Disinfection Effective Date and Review Addition of Substance for Health Care Regulation of Arsenic Regulation of Sulfate

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Regulation of Radon Risk Assessment by NAS Health Risk Reduction and Cost Analysis Proposed and Final Rules Alternative Maximum Contaminant Level Multimedia Radon Mitigation Programs Recycling of Filter Backwash Variance Technologies National Secondary Drinking Water Regulations Administrative Procedures and Consultation Science Advisory Board Review Section 1413—State Primary Enforcement Responsibility Section 1414—Enforcement of Drinking Water Regulations Scope of Coverage Notice of Violation Civil Action Public Notice General Requirements Form, Manner, and Frequency of Notice State Requirements Violations with Potential to Have Serious Adverse Effects on Human Health Written Notice Reports Consumer Confidence Reports USEPA Regulations Contents of Consumer Confidence Reports Governor Determination for Small Systems State Flexibility National Secondary Regulations Federal Preemption Federal Assistance Administrative Orders Consolidation Incentive Section 1415—Variances Small System Variances

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Section 1416—Exemptions Section 1417—Prohibition on Use of Lead Pipes, Solder, and Flux Section 1418—Monitoring of Contaminants Interim Monitoring Relief Permanent Monitoring Relief USEPA Guidelines Nonprimacy States Treatment as an NPDWR Other Monitoring Relief Section 1419—Operator Certification USEPA Guidelines SRLF Withholding Existing State Programs Cost Reimbursement Funding Authorization Section 1420—Capacity Development Authority for New Systems Significant Noncompliance Capacity Development Strategy Federal Assistance Variances and Exemptions Small Public Water Systems Technology Assistance Centers Environmental Finance Centers

Part C—Protection of Underground Sources of Drinking Water Section 1421—Regulations for State Programs Section 1422—State Primacy Enforcement Responsibility Section 1423—Enforcement of Program Section 1424—Interim Regulation of Underground Injection Section 1425—Optional Demonstration by States Relating to Oil or Natural Gas Section 1426—Regulation of State Programs

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Section 1427—Sole Source Aquifer Demonstration Program Section 1428—State Programs to Establish Wellhead Protection Areas Section 1429—State Groundwater Protection Grants

Part D—Emergency Powers Section 1431—Emergency Powers Section 1432—Tampering with Public Water Systems Section 1433—Terrorist and Other Intentional Acts Vulnerability Assessments Emergency Response Plans Section 1434—Contaminant Prevention, Detection, and Response Section 1435—Supply Disruption Prevention, Detection, and Response

Part E—General Provisions Section 1441—Assurance of Availability of Adequate Supplies of Chemicals Necessary for Treatment of Water Section 1442—Research, Technical Assistance, Information, and Training of Personnel Section 1443—Grants for State Programs Section 1444—Special Study and Demonstration Project Grants; Guaranteed Loans Section 1445—Records and Inspections Monitoring of Unregulated Contaminants Right of Entry Penalties Confidential Information Grantees and Federal Agencies Drinking Water Coolers Occurrence Database Small System Technologies Screening Methods

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Section 1446—National Drinking Water Advisory Council Section 1447—Federal Agencies Section 1448—Review Section 1449—Citizen’s Civil Action Section 1450—General Provisions Section 1451—Indian Tribes Section 1452—State Revolving Loan Funds State Allotments Use of Funds Intended Use Plans Fund Management Assistance for Disadvantaged Communities State Contribution Types of Assistance Administration of Loan Funds SRLF Needs Survey Indian Tribes Assistance to Other Areas Other Authorized Activities Delays Authorization Health Effects Studies Unregulated Contaminant Monitoring State of Virginia Demonstration Project Small Systems Technical Assistance Evaluation Section 1453—Source Water Quality Assessment Section 1454—Source Water Petition Program Petition Objectives Contaminants Addressed by a Petition Contents of a Petition Petition Approval Grants for State Programs

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USEPA Guidance Funding Authorization Statutory Construction Section 1455—Water Conservation Plan Section 1456—Assistance to Colonias Section 1457—Estrogenic Substances Screening Program Section 1458—Drinking Water Studies Subpopulations at Greater Risk Biological Mechanisms Studies on Harmful Substances in Drinking Water Waterborne Disease Occurrence Study

Part F—Additional Requirements to Regulate the Safety of Drinking Water Section 1461—Definitions Section 1462—Recall of Drinking Water Coolers with Lead-Lined Tanks Section 1463—Drinking Water Coolers Containing Lead Section 1464—Lead Contamination in School Drinking Water Section 1465—Federal Assistance for State Programs Regarding Lead Contamination in School Drinking Water

SECTION 1400—SHORT TITLE The name of this title is designated and known as the ‘‘Safe Drinking Water Act.’’

SECTION 1401—DEFINITIONS The legal meaning of the following terms are defined in Section 1401.  Primary Drinking Water Regulation (PDWR): a regulation that (1) applies to public water systems, (2) specifies contaminants that may have any adverse effect on the health of persons, (3) specifies for each contaminant a maximum contaminant level (MCL) or treatment technique, and (4) contains criteria and

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procedures to ensure compliance. The definition authorizes the U.S. Environmental Protection Agency (USEPA) to add equally effective quality control and testing procedures by guidance published in the Federal Register. The procedures are to be treated as an alternative for public water systems to the quality control and testing procedures listed in the regulation.  Secondary Drinking Water Regulation (SDWR): A regulation that applies to public water systems that specifies the maximum levels that are requisite to assure good aesthetic quality and protect the public welfare. Secondary regulations apply to contaminants that may adversely affect the odor or appearance of the water resulting in a substantial number of the persons served by the public water system to discontinue its use, or that may otherwise adversely affect the public welfare.  Maximum Contaminant Level (MCL): The maximum permissible level (concentration) of a contaminant in water that is delivered to any user of a public water system.  Public Water System (PWS): A public water system is defined as a system for the provision to the public of water for human consumption through pipes or other constructed conveyances that has at least 15 service connections or regularly serves at least 25 individuals. The term includes (1) any collection, treatment, storage, and distribution facilities under control of the operator of the system and used primarily in connection with the system and (2) any collection or pretreatment storage facilities not under such control that are used primarily in connection with the system. Public water systems may be publicly or privately owned. The 1996 amendments provide that a connection to a system that delivers water by a constructed conveyance other than a pipe is not considered a connection for the purpose of classification as a public water system if the water is used exclusively for purposes other than residential uses and water meeting the National Primary Drinking Water Regulations (NPDWRs) is provided for residential or similar uses.  Supplier of water: Any person who owns or operates a public water system.  Contaminant: Any physical, chemical, biological, or radiological substance or matter in water.  Administrator: The Administrator of the Environmental Protection Agency.  Agency: The U.S. Environmental Protection Agency.  Council: The National Drinking Water Advisory Council established under Section 1446.  Municipality: A city, town, or other public body created by or pursuant to state law, or an Indian tribe authorized by law.  Federal agency: Any department, agency, or instrumentality of the United States.

SECTION 1411—COVERAGE

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 Person: An individual, corporation, company, association, partnership, state, municipality, or federal agency (and includes officers, employees, and agents of any corporation, company, association, state, municipality, or federal agency).  State: In addition to the several states, only the District of Columbia, Guam, the Commonwealth of Puerto Rico, the Northern Mariana Islands, the Virgin Islands, American Samoa, and the Trust Territory of the Pacific Islands. For purposes of Section 1452, the term ‘‘state’’ means each of the 50 states, the District of Columbia, and the Commonwealth of Puerto Rico.  Indian Tribe: Any Indian tribe having a Federally recognized governing body carrying out substantial governmental duties and powers over any area. For purposes of Section 1452, the term includes any Native village {as defined in Sec. 3(c) of the Alaska Native Claims Settlement Act [43 USC 1602(c)]}.  Community Water System (CWS): A public water system that serves at least 15 service connections used by yearround residents of the area served by the system; or regularly serves at least 25 yearround residents.  Noncommunity Water System (NCWS): A public water system that is not a community water system.

SECTION 1411—COVERAGE National Primary Drinking Water Regulations (NPDWRs) apply to ‘‘each public water system in each state’’ (Sec. 1411). NPDWRs do not apply to public water systems that obtain water from a regulated public water system, have only distribution and storage facilities, do not resell the water, and are not an interstate carrier. Private water supplies (individual homes) are also not covered by NPDWRs or the SDWA.

SECTION 1412—NATIONAL DRINKING WATER REGULATIONS Section 1412 empowers USEPA to establish drinking water regulations and prescribes the manner and timing of regulations. National Primary Drinking Water Regulations The 1986 SDWA amendments redefined national interim and revised primary drinking water regulations promulgated prior to 1986 as NPDWRs [Sec. 1412(a)(1)]. Recommended MCLs published prior to 1986 were redefined as maximum contaminant level goals (MCLGs). MCLs and MCLGs for a contaminant must be proposed and promulgated simultaneously. The 1986 and 1996 SDWA amendments modified the SDWA to require USEPA to take certain actions to regulate specified contaminants. The 1986 SDWA

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TABLE C.1 Contaminants Required to be Regulated under the 1986 SDWA Volatile organic chemicals Benzene Carbon tetrachloride Chlorobenzene Dichlorobenzene 1,2-Dichloroethane 1,1-Dichloroethylene cis-1,2-Dichloroethylene

trans-1,2-Dichloroethylene Methylene chloride Tetrachloroethylene Trichlorobenzene 1,1,1-Trichloroethane Trichloroethylene Vinyl chloride Microbiology and Turbidity

Giardia lamblia Legionella Standard plate count

Total coliforms Turbidity Viruses Inorganics

Aluminum Antimony Arsenic Asbestos Barium Beryllium Cadmium Chromium Copper Cyanide Fluoride Lead

Mercury Molybdenum Nickel Nitrate Selenium Silver Sodium Sulfate Thallium Vanadium Zinc

Organics Acrylamide Adipates Alachlor Aldicarb Atrazine Carbofuran Chlordane Dalapon Dibromochloropropane (DBCP) Dibromomethane 1,2-Dichloropropane Dinoseb Diquat Endothall Endrin Epichlorohydrin Ethylene dibromide (EDB)

Glyphosate Hexachlorocyclopentadiene Lindane Methoxychlor Pentachlorophenol Phthalates Pichloram Polychlorinated biphenyls (PCBs) Polynuclear aromatic hydrocarbons (PAHs) Simazine 2,3,7,8-Tetrachlorobenzodioxin (dioxin) Toluene Toxaphene 2,4,5-TP (Silvex) 1,1,2-Trichloroethane Vydate Xylene

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TABLE C.1 (Continued) Radionuclides Beta-particle and photon radioactivity Gross alpha-particle activity Radium 226 and radium 228

Radon Uranium

Removed from SDWA list of 83 Aluminum Dibromomethane Molybdenum Silver

Sodium Vanadium Zinc

Substituted into SDWA list of 83 Aldicarb sulfone Aldicarb sulfoxide Ethylbenzene Heptachlor

Heptachlor epoxide Nitrite Styrene

amendments specifically required USEPA to set NPDWRs for 83 contaminants (Table C.1) listed in the Advance Notice for Proposed Rulemakings published March 4, 1982, and Oct. 5, 1983. USEPA was required to regulate these 83 contaminants, although up to 7 substitutes were allowed if regulation of the substitutes was more likely to be protective of public health. USEPA proposed and adopted the seven substitutes listed at the end of Table C.1. Specific timelines were specified for regulation development, as summarized in Table C.2. 1986 SDWA Amendments USEPA was given broad authority by Congress to publish MCLGs and NPDWRs for each contaminant that ‘‘in the judgment of the administrator, may have any adverse effect on the health of persons and which is known or anticipated to occur in public water systems.’’ This statute was the primary driving force behind the establishment of new drinking water regulations from 1986 to 1996. As in the 1974 SDWA, the adverse health effect of a contaminant need not be proved conclusively prior to regulation. The 1986 amendments required USEPA to develop a list of contaminants, known or anticipated to occur in public water systems, that may require regulation under this act. The first Drinking Water Priority List (DWPL) included the seven substitutes removed from the original list of 83. The DWPL was to be updated at 3-year intervals. At least 25 contaminants on each list were to be regulated within 24 months after the list was published. 1996 Amendments This statute was significantly revised by the 1996 SDWA amendments to change the contaminant listing and regulatory process and modify USEPA’s general

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SECTION-BY-SECTION SUMMARY OF THE SDWA

TABLE C.2 Water Quality Regulation Development Deadlines under the 1986 SDWA Amendments Date June 1986 June 1987

August 1987 December 19987

January 1988 June 1988 June 1989

January 1990 January 1991

Action SDWA amendments enacted Publish MCLGs and promulgate NPDWRs for nine of the contaminants on the list of 83 (Table C.1); publish proposed list of contaminants for substitution Publish final list of contaminants to be substituted Promulgate criteria under which filtration is required as a treatment technique for public water systems that may require regulation under the SDWA Publish priority list of contaminants known or anticipated to occur in public water systems that may require regulation under the SDWA Publish MCLGs and promulgate NPDWRs for at least 40 of the contaminants on the list of 83 (Table C.1) Publish MCLGs and promulgate NPDWRs for the remainder of the contaminants on the list of 83 (Table C.1); states must have adopted regulations to implement filtration requirements; promulgate NPDWRs requiring disinfection as a treatment technique for all public water systems Publish proposed MCLGs and NPDWRs for the 25 contaminants on the January 1988 priority list Publish MCLGs and promulgate NPDWRs for the 25 contaminants proposed in January 1990; publish updated priority list of contaminants known or anticipated to occur in public water systems

authority for regulating contaminants. However, the requirement to regulate the 83 contaminants (Table C.1) added by 1986 amendments was retained. Specific timelines specified for regulation development are summarized in Table C.3. The 1996 SDWA amendments [Sec. 1412(b)(1)(A)] require USEPA to publish an MCLG and promulgate an NPDWR for a contaminant that 1. Has an adverse effect on the health of persons 2. Is known to occur or there is a substantial likelihood that the contaminant will occur in public water systems with a frequency and at levels of public health concern 3. In the sole judgment of USEPA, regulation of such contaminant presents a meaningful opportunity for health risk reduction for persons served by public water systems This general authority to regulate contaminants in drinking water does not apply to contaminants for which an NPDWR was promulgated as of the date of enactment of the SDWA amendments of 1996 (Aug. 6, 1996).

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TABLE C.3 Water Quality Regulation Development Deadlines under the SDWA as Amended in 1996 Date

Action List of 83 Contaminants

By June 19, 1987

USEPA must regulate at least 9 contaminants from the list of 83 [Sec. 1412(2)(A)] USEPA must regulate at least 40 contaminants from the list of 83 [Sec. 1412(2)(A)] USEPA must regulate the remainder of contaminants from the list of 83 [Sec. 1412(2)(A)]

By June 19, 1988 By June 19, 1999

Filtration for Systems Using Surface Water By Dec. 16, 1987

USEPA must propose and promulgate NPDWRs specifying when filtration is required for surface water systems [Sec. 1412(b)(7)(C)]

After Aug. 6, 1999, but no later than the Stage II DBP rule

USEPA must promulgate NPDWRs requiring disinfection for all public water systems, including surface water systems and, as necessary, groundwater systems; as part of the regulations, USEPA must promulgate criteria to determine whether disinfection is to be required for a ground water system [Sec. 1412(b)(8)]

Disinfection

Arsenic By Feb. 3, 1997 By Jan. 1, 2000 By Jan. 1, 2001

By Feb. 6, 1999 By Aug. 6, 2001

By Feb. 6, 1999 By Aug. 6, 1999 By Aug. 6, 2000

USEPA must develop a health effects study plan [Sec. 1412(b)(12)(A)(ii)] USEPA must propose an NPDWR [Sec. 1412(b)(12)(A)(iv)] USEPA must promulgate an NPDWR [Sec. 1412(b)(120(A)(v)] Sulfate USEPA and CDC must jointly conduct a new dose– response study [Sec. 1412(b)(12)(B)(i)] USEPA to determine whether to regulate sulfate [Sec. 1412(b)(12)(B)(ii)] Radon USEPA must publish a risk–cost study [Sec. 1412(b)(130(C)] USEPA must propose an MCLG and NPDWR [Sec. 1412(b)(13)(D)] USEPA must publish an MCLG and promulgate an NPDWR [Sec. 1412(b)(13)(E)]

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TABLE C.3 (Continued) Date

Action Disinfectants=Disinfection Byproducts (D=DBPs)

According to schedule in Table III.13, Fed. Reg. 59:6361

USEPA must promulgate Stage I and Stage II rules [Sec. 1412(b)(2)(C)]

Enhanced Surface Water Treatment Rule (ESWTR) According to schedule in Table III.13, Fed. Ref. 59:6361

USEPA must promulgate an interim and final ESWTR [Sec. 1412(b)(2)(C)] New Contaminants

By Feb. 6, 1998, and every 5 years thereafter No later than Aug. 6, 2001, and every 5 years thereafter No later than 24 months after decision to regulate Within 18 months of proposal; deadline may be extended 9 months if necessary Three years after promulgation; up to 2-year extension possible

USEPA to list contaminants that may require regulation [Sec. 1412(b)(1)(B)] USEPA to make a determination whether to regulate at least five contaminants [Sec. 1412(b)(1)(B)(ii)] USEPA to publish a proposed MCLG and NPDWR [Sec. 1412(b)(1)(E)] USEPA to publish a proposed MCLG and NPDWR [Sec. 1412(b)(1)(E)] NPDWRs become effective [Sec. 1412(b)(10)]

Recycling of Filter Backwash Water By Aug. 6, 2000

USEPA must regulate backwash water recycle unless it is addressed in the ESWTR prior to this date [Sec. 1412(b)(14)] Urgent Threats to Public Health

Anytime

No later than 5 years after promulgation

USEPA may promulgate an interim NPDWR to address contaminants that present an urgent threat to public health [Sec. 1412(b)(1)(D)] USEPA is required to repromulgate or revise as appropriate an interim NPDWR as a final NPDWR [Sec. 1412(b)(1)(D)] Review of Regulations

No less often than every 6 years

USEPA is required to review and revise as appropriate each NPDWR [Sec. 1412(b)(9)]

Identification of Unregulated Contaminants for Listing. USEPA is required under Section 1412(b)(1)(B) to publish a list of contaminants that may require regulation under the SDWA no later than Feb. 6, 1998, and every 5 years thereafter. USEPA is to consult with the scientific community, including the Science Advisory Board,

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when preparing the list, and provide notice and opportunity for public comment. The occurrence database established under Section 1445(g) is to be considered in determining whether the contaminants are known or anticipated to occur in public water systems. At the time of publication, listed contaminants are not to be subject to any proposed or promulgated NPDWR. Unregulated contaminants considered for listing must include, but not be limited to, substances referred to in Section 101(14) of the Comprehensive Environmental Response, Compensation, and Liability Act of 1980 and substances registered as pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The decision about whether to select an unregulated contaminant for a list under this clause is not subject to judicial review. Determination to Regulate. No later than Aug. 6, 2001, and every 5 years thereafter, USEPA is required to make determinations on whether to regulate no fewer than five listed contaminants. Notice of the preliminary determination must be given along with an opportunity for public comment. The determination to regulate must be based on the best available public health information, including the occurrence database established under Section 1445(g). To regulate a contaminant, USEPA must find that the contaminant has an adverse effect on the health of persons, occurs or is likely to occur in public water systems with a frequency and at levels of public health concern, and that regulation of the contaminant presents a meaningful opportunity for health risk reduction for persons served by public water systems. USEPA may make a determination to regulate a contaminant that is not listed if the determination to regulate is made on the basis of these criteria. A determination not to regulate a contaminant is considered final agency action and subject to judicial review. Each document setting forth the determination for a contaminant must be available for public comment at the time the determination is published. Regulatory Priorities. When selecting unregulated contaminants for consideration for regulation, USEPA is required under Section 1412(b)(1)(C) to select contaminants that present the greatest public health concern. In making this selection, USEPA must take into consideration, among other factors of public health concern, the effect of the contaminants on subgroups that represent a meaningful portion of the general population (such as infants, children, pregnant women, the elderly, individuals with a history of serious illness, or other subpopulations) that are identifiable as being at greater risk of adverse health effects due to exposure to contaminants in drinking water than the general population. Urgent Threats to Public Health. An interim NPDWR may be promulgated for a contaminant under Section 1412(b)(1)(D) without making a regulatory determination under Section 1412(b)(4)(C), or completing the analysis under Section 1412(b)(3)(C), to address an urgent threat to public health. USEPA is to consult with and respond in writing to any comments provided by the Secretary of Health and Human Services, acting through the director of the Centers for Disease Control and Prevention (CDC) or the director of the National Institutes of Health.

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SECTION-BY-SECTION SUMMARY OF THE SDWA

A determination for any contaminant under Section 1412(b)(4)(C) subject to an interim regulation must be issued, and a completed analysis meeting the requirements of Section 1412(b)(3)(C) must be published, not later than 3 years after the date on which the regulation is promulgated. The regulation must be repromulgated, or revised if appropriate, not later than 5 years after that date. Regulation Deadlines. For each contaminant that USEPA determines to regulate, an MCLG must be published and an NPDWR promulgated by rule under Section 1412(b)(1)(E). An MCLG and NPDWR must be proposed for a contaminant not later than 24 months after the determination to regulate. The proposed regulation may be published concurrent with the determination to regulate. USEPA is required to publish an MCLG and promulgate an NPDWR within 18 months after proposal. The agency, by notice in the Federal Register, may extend the deadline for such promulgation for up to 9 months. The 1996 amendments retain in Section 1412(b)(2)(A) the requirement to regulate the 83 contaminants added by the 1986 amendments, and the previous provision allowing 7 substitutes to the list in Section 1412(b)(2)(B). Hence, any contaminant on the list of 83 not regulated as of Aug. 6, 1996, and not addressed specifically in the 1996 amendments, is required to be regulated. USEPA is required under Section 1412(b)(2)(C) to promulgate an Interim Enhanced Surface Water Treatment Rule, a Final Enhanced Surface Water Treatment Rule, a Stage I Disinfectants and Disinfection By-products Rule, and a Stage II Disinfectants and Disinfection By-products Rule in accordance with the schedule published as Table III.13 in the proposed Information Collection Rule ([Fed. Reg. 59:6361 (Feb. 10, 1994)]. If a delay occurs with respect to the promulgation of any rule in the schedule, all subsequent rules must be completed as expeditiously as practicable but no later than a revised date that reflects the interval or intervals for the rules in the schedule. Health Advisory and Other Actions. USEPA may publish health advisories (that are not regulations) or take other appropriate actions for contaminants not subject to any NPDWR under Section 1412(b)(1)(F).

Risk Assessment, Management, and Communication Section 1412b(3) to addresses risk assessment issues and was added by the 1996 SDWA amendments.

Use of Science in Decisionmaking When establishing NPDWRs, USEPA is required under Section 1412(b)(3)(A), to the degree that an agency action is based on science, to use (1) the best available, peer-reviewed science and supporting studies conducted in accordance with sound and objective scientific practices, and (2) data collected by accepted methods or best available methods (if the reliability of the method and the nature of the decision justifies the use of data).

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Public Information on Health Effects When establishing NPDWRs, USEPA must ensure under Section 1412(b)(3)(B) that information presented on public health effects is comprehensive, informative, and understandable. USEPA must specify, in a document made available to the public, 1. 2. 3. 4.

Each population addressed by any estimate of public health effects. The expected risk or central estimate of risk for the specific populations. Each appropriate upper-bound or lower-bound estimate of risk. Each significant uncertainty identified in the process of the assessment of public health effects and studies that would assist in resolving the uncertainty. 5. Peer-reviewed studies known to USEPA that support, are directly related to, or fail to support any estimate of public health effects and the methodology used to reconcile inconsistencies in the scientific data.

Health Risk Reduction and Cost Analysis When proposing an NPDWR that includes an MCL, USEPA must publish under Section 1412(b)(3)(C), seek public comment on, and use an analysis of each of the following for the MCL being considered and each alternative MCL: 1. Quantifiable and nonquantifiable health risk reduction benefits for which there is a factual basis in the rulemaking record to conclude that such benefits are likely to occur as the result of treatment to comply with each level. 2. Quantifiable and nonquantifiable health risk reduction benefits for which there is a factual basis in the rulemaking record to conclude that such benefits are likely to occur from reductions in co-occurring contaminants that may be attributed solely in compliance with the MCL, excluding benefits resulting from compliance with other proposed or promulgated regulations. 3. Quantifiable and nonquantifiable costs for which there is a factual basis in the rulemaking record to conclude that such costs are likely to occur solely as a result of compliance with the MCL, including monitoring, treatment, and other costs, and excluding costs resulting from compliance with other proposed or promulgated regulations. 4. The incremental costs and benefits associated with each alternative MCL considered. 5. The effects of the contaminant on the general population, and on groups within the general population, such as infants, children, pregnant women, the elderly, individuals with a history of serious illness, or other subpopulations that are identified as likely to be at greater risk of adverse health effects due to exposure to contaminants in drinking water than the general population. 6. Any increased health risk that may occur as the result of compliance, including risks associated with co-occurring contaminants.

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SECTION-BY-SECTION SUMMARY OF THE SDWA

7. Other relevant factors, including the quality and extent of the information, the uncertainties in the analysis of the above factors, and factors with respect to the degree and nature of the risk. When proposing an NPDWR that includes a treatment technique, USEPA must publish and seek public comment on an analysis of the health risk reduction benefits and costs likely to be experienced as a result of compliance with the treatment technique and alternative treatment techniques that are being considered, taking into account the factors above, as appropriate. USEPA is authorized to identify valid approaches for the measurement and valuation of benefits, including approaches to identify consumer willingness to pay for reductions in health risks from drinking water contaminants. An authorization of $35 million per year for each of fiscal years 1996 through 2003 is included for the USEPA Office of Ground Water and Drinking Water to conduct studies, assessments, and analyses in support of regulations or the development of methods. MCLGs and MCLs MCLGs are nonenforceable, health-based goals. Section 1412(b)(4)(A) requires that MCLGs ‘‘be set at a level at which no known or anticipated adverse effect on human health occurs and that allows for an adequate margin of safety’’ without regard to the cost of reaching these goals. MCLs are enforceable standards. Section 1412(b)(4)(B) required that MCLs be set ‘‘as close to the MCLG as is feasible.’’ ‘‘Feasible’’ is defined in Section 1412(b)(4)(D) as feasible with the use of the best technology, treatment techniques, and other means that are available (taking cost into consideration). USEPA is required to examine treatment technologies, techniques, or other means for efficacy under field conditions and not solely under laboratory conditions when determining feasibility. Granular activated carbon (GAC) is designated as feasible for the control of synthetic organic chemicals (SOCs), and any technology, treatment technique, or other means designated as feasible for the control of SOCs must be at least as effective as GAC. At the time USEPA proposes an NPDWR, Section 1412(b)(4)(D) requires the agency to publish a determination as to whether the benefits of the MCL do or do not justify the costs, based on the health risk reduction and cost analysis required under Section 1412(b)(3)(C). Feasible Technologies Section 1412(b)(4)(E) requires that each NPDWR that includes an MCL must list the technology, treatment technique, and other means feasible for purposes of meeting the MCL [referred to as best available technology (BAT)]. The amended SDWA does not, however, require the use of BAT. Systems may use any appropriate technology or other means acceptable to the state to comply with an MCL.

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List of Technologies for Small Systems When listing the technology, treatment techniques, and other means USEPA finds to be feasible for meeting an MCL or treatment technique, the agency must include ‘‘any technology, treatment technique, or other means that is affordable’’ for small systems [Sec. 1412(b)(4)(E)(ii)]. The quality of the source water to be treated must be considered when listing any technology, treatment technique, or other means. USEPA must consult with the states when determining which technologies, techniques, or other means to list. Lists are to be developed for small public water systems serving 1. A population of 10,000 or fewer but more than 3300. 2. A population of 3300 or fewer but more than 500. 3. A population of 500 or fewer but more than 25. Packaged or modular systems and point-of-entry (POE) or point-of-use (POU) treatment units may be included in the list. POE and POU treatment units must be owned, controlled, and maintained by the public water system or by a person under contract with the public water system to ensure proper operation and maintenance and compliance with the MCL or treatment technique. Units must be equipped with mechanical warnings to ensure that customers are automatically notified of operational problems. POU treatment technology cannot be listed for a microbial contaminant or an indicator of a microbial contaminant. If the American National Standards Institute (ANSI) has issued product standards applicable to a specific type of POE or POU treatment unit, individual units of that type must be independently certified against the ANSI standard before it can be accepted for compliance with an MCL or treatment technique requirement. List of Technologies that Achieve Compliance USEPA was required to issue a list of technologies that achieve compliance with MCLs or treatment techniques promulgated prior to the date of enactment (Aug. 6, 1996) for each of the previously mentioned three categories of public water systems [Sec. 1412(b)(4)(E)(iii)]. This list must be issued not later than 2 years after enactment (Aug. 6, 1998). Listing of Additional Technologies Any time after promulgation of an NPDWR, USEPA may supplement the list of technologies to describe additional or innovative treatment technologies for the categories of small water systems described earlier [Sec. 1412(b)(4)(E)(iv)]. Technologies that Meet the Surface Water Treatment Rule Within one year of enactment (Aug. 6, 1996), USEPA is required to list technologies for the three categories of small systems previously described that meet the Surface Water Treatment Rule (SWTR) [Sec. 1412(b)(4)(E)(v)].

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SECTION-BY-SECTION SUMMARY OF THE SDWA

Additional Health Risk Considerations USEPA may establish an MCL at a level other than the feasible level, if the technology, treatment techniques, and other means used to determine the feasible level would result in an increase in the health risk from drinking water by [Sec. 1412(b)(5)(A)] either (1) increasing the concentration of other contaminants in drinking water or (2) interfering with the efficacy of drinking water treatment techniques or processes that are used to comply with other NPDWRs. If an MCL or a treatment technique for any contaminant or contaminants is set at other than the feasible level [Sec. 1412(b)(5)(B)] 1. The MCL(s) or treatment techniques must minimize the overall risk of adverse health effects by balancing the risk from the contaminant and the risk from other contaminants the concentrations of which may be affected by the use of a treatment technique or process that would be employed to attain the MCL or levels. 2. The combination of technology, treatment techniques, or other means required to meet the level or levels shall not be more stringent than is feasible [as defined in Sec. 1412(b)(4)(D)]. Additional Health Risk Reduction and Cost Considerations If USEPA decides that the benefits of an MCL would not justify the costs of complying with the level, the agency is given the authority to, after notice and opportunity for public comment, promulgate an MCL for the contaminant that maximizes health risk reduction benefits at a cost that is justified by the benefits [Sec. 1412(b)(6)(A)]. This authority cannot be used if the benefits of compliance with an NPDWR for the contaminant in question experienced by (1) persons served by large public water systems and (2) persons served by systems that are unlikely to receive a variance under Section 1415(e) (relating to small system variances), would justify the costs to the systems of complying with the regulation [Sec. 1412(b)(6)(B)]. This authority also does not apply 1. If the contaminant is found almost exclusively in small systems eligible under Section 1415(e) for a small system variance [Sec. 1412(b)(6)(B)]. 2. In establishing an MCL in a Stage l or Stage II NPDWR for contaminants that are disinfectants or disinfection byproducts [Sec. 1412(b)(6)(C)]. 3. In establishing an MCL or treatment technique requirement for the control of Cryptosporidium [Sec. 1412(b)(6)(C)]. The authority may be used to establish regulations for the use of disinfection by systems relying on groundwater sources. A determination by USEPA that the benefits of an MCL or treatment requirement do or do not justify the costs of complying with the level will be reviewed by the

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court pursuant to Section 1448 only as part of a review of a final NPDWR that has been promulgated on the basis of the determination [Sec. 1412(b)(6)(D)]. The determination will not be set aside by the court under Section 1448 unless the court finds that the determination is arbitrary and capricious. Treatment Technique Section 1412(b)(7) allows USEPA to require the use of a treatment technique in lieu of establishing an MCL if it is determined that monitoring for the contaminant is not economically or technologically feasible. The availability, accuracy, and practicality of available analytical methods for a contaminant significantly influence whether an MCL or a treatment technique will be established for that contaminant. Mandatory Filtration USEPA is required under Section 1412(b)(7)(C) to propose and promulgate criteria under which filtration is required as a treatment technique for public water systems supplied by surface water sources. The quality of source waters, protection afforded by watershed management, treatment practices (including disinfection and length of water storage), and other factors relevant to protection of health must be considered. USEPA was required to specify procedures by which the state determines which public water systems must filter. Regulations were to be developed and implemented within specific deadlines. USEPA’s SWTR satisfied the requirements of the mandatory filtration section of the SDWA. The 1996 SDWA amendments allow primacy states, on a case-by-case basis, and after notice and opportunity for public comment, to establish treatment requirements as an alternative to filtration for water systems having uninhabited, undeveloped watersheds in consolidated ownership, and having control over access to, and activities in, those watersheds [Sec. 1412(b)(7)(C)(v)]. The state must determine, and USEPA must concur, that the quality of the source water and the alternative treatment requirements established by the state ensure greater removal or inactivation efficiencies of pathogenic organisms for which NPDWRs have been promulgated or that are of public health concern than would be achieved by the combination of filtration and chlorine disinfection. Mandatory Disinfection The 1996 SDWA amendments required USEPA to promulgate NPDWRs requiring disinfection as a treatment technique for all public water systems, including surface water systems and, as necessary, groundwater systems [Sec. 1412(b)(8)]. The regulations must be set at any time after 3 years of enactment of the SDWA amendments of 1996 (Aug. 6, 1999), but not later than the date of promulgation of the Stage II rulemaking for disinfectants and disinfection byproducts. USEPA is required to promulgate criteria to be used by primacy agencies to determine whether disinfection should be required as a treatment technique for

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SECTION-BY-SECTION SUMMARY OF THE SDWA

groundwater systems. At the same time, USEPA must issue a rule specifying criteria to be used by primacy agencies to grant variances from this requirement. In providing technical assistance to small systems [Sec. 1442(e)], primacy agencies are to give special consideration to assisting small public water systems in complying with disinfection regulations. The USEPA SWTR satisfied the disinfection requirement for public water systems using surface water sources. A separate rule covering groundwater disinfection currently is under development. Effective Date and Review USEPA is required to review and revise, as appropriate, each NPDWR no less often than every 6 years [Sec. 1412(b)(9)]. Any revision of an NPDWR is to be promulgated in accordance with the SDWA as amended in 1996, except that each revision must maintain, or provide for greater, protection of the health of persons. Addition of Substances for Healthcare No NPDWR may require the addition of any substance for preventive healthcare purposes unrelated to contamination of drinking water [Sec. 1412(b)(II)]. Regulation of Arsenic The 1996 SDWA amendments included provisions regarding the regulation of arsenic in drinking water [Sec. 1412(b)(12)(A)]. USEPA is required to develop ‘‘a comprehensive plan for study in support of drinking water rulemaking to reduce the uncertainty in assessing health risks associated with exposure to low levels of arsenic.’’ The plan was to be completed no later than 180 days after enactment (Feb. 3, 1997). The agency must consult with the National Academy of Sciences, other federal agencies, and interested public and private entities. In carrying out the study plan, the agency may enter into cooperative agreements with other federal agencies, state and local governments, and other interested public and private entities. An authorization of $2,500,000 is included for each of fiscal years 1997 through 2000 for the arsenic studies. An NPDWR for arsenic was to be proposed no later than Jan. 1, 2000. A final NPDWR was to be promulgated no later than Jan. 1, 2001. The conference report includes language indicating that USEPA should work with the AWWA Research Foundation (AWWARF) to carry out study projects, if AWWARF contributes matching funds. Regulation of Sulfate Before promulgating an NPDWR for sulfate, USEPA and the director of the Centers for Disease Control and Prevention (CDC) are required to jointly conduct an

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additional study to establish a reliable dose–response relationship for the adverse human health effects that may result from exposure to sulfate in drinking water [Sec. 1412(b)(12)(B)]. The study is to include the health effects that may be experienced by groups within the general population (including infants and travelers) that are potentially at greater risk of adverse health effects as the result of exposure. The study must be conducted in consultation with interested states and be based on the best available, peer-reviewed science and supporting studies conducted in accordance with sound and objective scientific practices. It must be completed no later than 30 months after the date of enactment of the SDWA Amendments of 1996 (Feb. 6, 1999). USEPA is required to include sulfate among the five or more contaminants for which a determination to regulate is to be made no later than 5 years after the date of enactment of the SDWA Amendments of 1996 (Aug. 6, 2001). The agency may regulate sulfate in drinking water, but is not required to do so. Any sulfate regulation must include requirements for public notification and options for the provision of alternative water supplies to populations at risk as a means of complying with the regulation in lieu of a best available treatment technology or other means. Regulation of Radon USEPA is required to withdraw the July 18, 1991, proposed NPDWR for radon. The agency must propose and promulgate a regulation for radon under the SDWA as amended by the SDWA Amendments of 1996 [Sec. 1412(b)(13)]. Risk Assessment by NAS Prior to proposing an NPDWR for radon, USEPA was required to arrange for the National Academy of Sciences (NAS) to prepare a risk assessment for radon in drinking water using the best available science [Sec. 1412(b)(13)(A)]. The risk assessment was to consider each of the risks associated with exposure to radon from drinking water and consider studies on the health effects of radon at levels and under conditions likely to be experienced through residential exposure. The risk assessment was to be peer-reviewed. USEPA was also required to arrange for the NAS to prepare an assessment of the health risk-reduction benefits associated with various mitigation measures to reduce radon levels in indoor air. Health Risk Reduction and Cost Analysis No later than Feb. 6, 1999, USEPA is required to publish for public comment a health risk reduction and cost analysis for potential MCLs that are being considered for radon in drinking water [Sec. 1412(b)(13)(C)]. The agency is to include in the proposed rule a response to all significant public comments received on the analysis. Proposed and Final Rules USEPA was required to propose an MCLG and an NPDWR for radon no later than Aug. 6, 1999 [Sec. 1412(b)(13)(D)].

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SECTION-BY-SECTION SUMMARY OF THE SDWA

USEPA was required to publish an MCLG and promulgate an NPDWR for radon no later than 12 months after proposal (Aug. 6, 2000). The final rule is to be based on the NAS risk assessment and the health risk reduction and cost analysis. The costs and benefits of control programs for radon from other sources is to be taken into account in considering the risk assessment and the health risk reduction and cost analysis. Alternative Maximum Contaminant Level If the final MCL for radon in drinking water is more stringent than necessary to reduce the contribution to radon in indoor air from drinking water to a concentration that is equivalent to the national average concentration of radon in outdoor air, then USEPA must simultaneously promulgate an alternative MCL for radon that would result in a contribution of radon from drinking water to radon levels in indoor air equivalent to the national average concentration of radon in outdoor air [Sec. 1412(b)(13)(F)]. If an alternative MCL is promulgated, then USEPA is required to publish guidelines for state programs. Notice and opportunity for public comment is required, and the guidelines are to be prepared in consultation with the states. The guidelines are to include criteria for multimedia measures to mitigate radon levels in indoor air, and are to be used by the states in preparing multimedia radon mitigation programs. The guidelines are to take into account data from existing radon mitigation programs and the NAS assessment of mitigation measures. Multimedia Radon Mitigation Programs A state may develop and submit for USEPA approval a multimedia program to mitigate radon levels in indoor air. If, after notice and the opportunity for public comment, the program is approved, public water systems in the state may comply with the alternative MCL in lieu of the MCL in the NPDWR [Sec. 1412(b)(13)(G)(i)]. State programs may rely on a variety of mitigation measures, including public education, testing, training, technical assistance, remediation grant and loan or incentive programs, or other regulatory or nonregulatory measures. The effectiveness of elements in state programs is to be evaluated by USEPA on the basis of NAS assessment described earlier and the guidelines published by USEPA described below [Sec. 1412(b)(13)(G)(ii)]. USEPA is required to approve a state program if the health risk-reduction benefits expected to be achieved by the program are equal to or greater than the health riskreduction benefits that would be achieved if each public water system in the state complied with the MCL. USEPA is required to approve or disapprove a program within 180 days of receipt. A program that is not disapproved during this period is deemed approved. A program that is disapproved may be modified to address USEPA objections and be resubmitted for approval [Sec. 1412(b)(13)(G)(iii)]. USEPA is required to periodically, but not less often than every 5 years, review each multimedia mitigation program to determine whether it continues to meet the

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requirements for approval. After written notice to the state and an opportunity for the state to correct any deficiency in the program, USEPA is required to withdraw approval of programs that no longer comply with the requirements [Sec. 1412(b)(13XG)(iv)]. If, within 90 days after the promulgation of an alternative MCL, the governor of a state submits a letter to USEPA committing to develop a multimedia mitigation program, the effective date of the NPDWR in the state will be extended for a period of 18 months [Sec. 1412(b)(13)(G)(v)]. If a state chooses not to submit a multimedia mitigation program for approval or has submitted a program that has been disapproved, any public water system in the state may submit a program for USEPA approval according to the same criteria, conditions, and approval process that would apply to a state program. USEPA is required to approve a multimedia mitigation program if the health risk-reduction benefits expected to be achieved by the program are equal to or greater than the health risk-reduction benefits that would result from compliance by the public water system with the MCL for radon [Sec. 1412(b)(13)(G)(vi)].

Recycling of Filter Backwash USEPA is required to promulgate a regulation to govern the recycling of filter backwash water within the treatment process of a public water system [Sec. 1412(b)(14)]. The regulation is due no later than Aug. 6, 2000, unless backwash recycling is addressed by the Enhanced Surface Water Treatment Rule prior to that date.

Variance Technologies At the same time USEPA promulgates an NPDWR for a contaminant, the agency is required to issue guidance or regulations describing the best treatment technologies, treatment techniques, or other means, that are available and affordable for small systems (referred to as variance technology). Variance technology is to be identified by USEPA based on examination for efficacy under field conditions and not solely under laboratory conditions, in consultation with the states [Sec. 1412(b)(15)]. USEPA is to list variance technologies for public water systems of varying size, considering the quality of the source water to be treated. Variance technologies are to be identified for water systems serving  A population of 10,000 or fewer but more than 3300  A population of 3300 or fewer but more than 500  A population of 500 or fewer but more than 25 if, considering the quality of the source water to be treated, no treatment technology is listed as feasible for public water systems of that size [under Sec. 1412(b)(4)(E)].

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SECTION-BY-SECTION SUMMARY OF THE SDWA

Variance technologies may not achieve compliance with the MCL or treatment technique requirement of the regulation, but are to achieve the maximum reduction or inactivation efficiency that is affordable considering the size of the system and the quality of the source water. The guidance or regulations are not to require the use of a technology from a specific manufacturer or brand [Sec. 1412(b)(15(A)]. USEPA is prohibited from identifying any variance technology, unless the agency has determined, considering the quality of the source water to be treated and the expected useful life of the technology, that the variance technology is protective of public health [Sec. 1412(b)(15)(B)]. USEPA is required to provide the following in the guidance or regulations identifying variance technologies [Sec. 1412(b)(15)(C)]: 1. Any assumptions supporting the public health determination, when the assumptions concern the public water system to which the technology may be applied, or its source waters. 2. Any assumptions used in determining affordability, taking into consideration the number of persons served by such systems. 3. As much reliable information as practicable on performance, effectiveness, limitations, costs, and other relevant factors, including the applicability of variance technology to waters from surface and underground sources. USEPA is required to issue no later than Aug. 6, 1998, after consultation with the states, guidance, or regulation; for variance technologies for each NPDWR promulgated prior to Aug. 6, 1996, for which a variance may be granted under Section 1415(e). At any time after an NPDWR has been promulgated, the agency may issue guidance or regulations describing additional variance technologies [Sec. 1412(b)(15)(D)]. USEPA is required to review variance technologies no less often than every 7 years or on receipt of a petition supported by substantial information. Revised guidance or regulations must be issued if new or innovative variance technologies become available that achieve an equal or greater reduction or inactivation efficiency than the variance technologies previously identified. No public water system will be required to replace a variance technology during the useful life of the technology for the sole reason that a more efficient variance technology has been listed [Sec. 1412(b)(15)(D)]. National Secondary Drinking Water Regulations USEPA is authorized to propose and promulgate National Secondary Drinking Water Regulations (NSDWRs) [Sec. 1412(c)]. NSDWRs may be established as the agency considers appropriate and may be amended and revised as needed. NSDWRs are based on aesthetic, as opposed to health, considerations and are not federally enforceable, but some states have adopted NSDWRs as enforceable standards.

SECTION 1413—STATE PRIMARY ENFORCEMENT RESPONSIBILITY

661

Administrative Procedures and Consultation Regulations are to be prescribed in accordance with Section 553 of Title 5, United States Code [Sec. 1412(d)]. An opportunity for public hearing prior to promulgation is required. The administrator is to consult with the secretary of Health and Human Services and the National Drinking Water Advisory Council (NDWAC) regarding proposed and final rules.

Science Advisory Board Review Before proposing any MCLG or NPDWR, USEPA must request comments from the Science Advisory Board (SAB), which can respond any time before promulgation of the regulation [Sec. 1412(e)]. USEPA does not, however, have to postpone promulgation if no comments are received.

SECTION 1413—STATE PRIMARY ENFORCEMENT RESPONSIBILITY USEPA may delegate primary enforcement responsibility, or primacy, to the state (Sec. 1413). USEPA has developed primacy requirements as directed by Section 1413(b), which states must follow to apply for and retain primacy. Section 1413(a) specifies six general requirements that must be met for a state to receive primacy: 1. Adopt drinking water regulations that are no less stringent than the NPDWRs no later than 2 years after promulgation by USEPA, except that USEPA may provide for an extension of not more than 2 years if the extension is necessary and justified. 2. Adopt and implement adequate procedures for enforcement. 3. Retain records and prepare reports as USEPA may require. 4. If issued, permit variances or exemptions in a manner that is no less stringent than permitted under Sections 1415 and 1416. 5. Adopt and be able to implement an adequate plan for the provision of safe drinking water under emergency circumstances, including earthquakes, floods, hurricanes, and other natural disasters. 6. Adopt authority for administrative penalties (unless prohibited by the state constitution) of not less than $1000 per day of violation in the case of water systems serving more than 10,000 persons, and that is adequate to ensure compliance in the case of any other system. The 1996 SDWA Amendments added a provision for interim primary enforcement authority [Sec. 1413(c)]. A state that has primary enforcement authority for each existing NPDWR will be considered to have primary enforcement authority with respect to each new or revised NPDWR during the period beginning on the

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SECTION-BY-SECTION SUMMARY OF THE SDWA

effective date of a regulation adopted and submitted by the state with respect to the new or revised NPDWR and ending at such time as the USEPA makes a primacy determination with respect to that regulation.

SECTION 1414—ENFORCEMENT OF DRINKING WATER REGULATIONS The enforcement provisions of the act were amended in 1996 to expand the scope of coverage, clarify enforcement in nonprimacy states, revise public notice requirements, require consumer confidence reports, increase civil penalties, and include an incentive for consolidation (Sec. 1414). Scope of Coverage Enforcement action may be taken against a public water system that does not comply with an ‘‘applicable requirement.’’ ‘‘Applicable requirement’’ is defined as [Sec. 1414(i)]    

a requirement of Section 1412, 1414, 1415, 1416, 1417, 1433, 1441, or 1445; a regulation promulgated under one of the above sections; a schedule or requirement imposed under one of the above sections; and a requirement of, or permit issued under, an applicable state program for which USEPA has made a determination that the requirements of Section 1413 have been satisfied, or an applicable approved state program.

Notice of Violation The administrator is required to issue a notice of violation to any system that does not have a variance or exemption and is violating any applicable requirement, or is not complying with a variance or exemption [Sec. 1414(a)(1)(A)]. The primacy agency must also be notified. USEPA is required to provide advice and technical assistance to the state and the public water system as appropriate to bring the system into compliance. If after 30 days of the notice of violation the state has not taken appropriate enforcement action, the administrator is required to take civil action under Section 1414(b) or issue an administrative order requiring compliance. In nonprimacy states, USEPA is required to notify an appropriate elected official, if any, with jurisdiction over the public water system prior to taking enforcement action [Sec. 1414(a)(2)]. Civil Action USEPA is empowered to bring a civil action in the appropriate U.S. district court to require compliance with [Sec. 1414(b)]

SECTION 1414—ENFORCEMENT OF DRINKING WATER REGULATIONS

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 Any applicable requirement (as defined above).  An administrative order.  Any schedule or other requirement imposed by a variance or exemption. The penalty that a court may impose was increased in 1986 from $5000 to a maximum of $25,000 for each day of the violation. If USEPA issues an administrative order and the total penalty does not exceed $5000, the agency can assess the fine without going to court, but a notice and opportunity for public comment must be provided, unless the person against whom the penalty is assessed requests a hearing on the record by an administrative law judge. Any penalty over $5000 but not exceeding $25,000 is assessed by USEPA after notice and opportunity for hearing on the record. Penalties exceeding $25,000 must be assessed by a district court [Sec. 1414(g)]. Public Notfication The 1974 SDWA required owners or operators of community water systems to notify their customers when drinking water standards were violated. The original purpose of the public notification requirement was stated as part of the House of Representatives Report on the 1974 SDWA (House Report 93-1185). The purpose of this notice requirement is to educate the public as to the extent to which public water systems serving them are performing inadequately in light of the objectives and requirements of this bill. Such public education is deemed essential by the Committee in order to develop public awareness of the problems facing public water systems . . . and to advise the public of potential or actual health hazards.

Public notification provisions of the 1974 SDWA were cumbersome because all violations were treated the same. The requirements were amended in 1986, directing USEPA to revise the public notification regulations, and new regulations were promulgated in October 1987. Various types of public notices were described based on the frequency and public health impact of the violation. Public notification provisions were modified again in 1996 [Sec. 1414(c)], and are summarized below. General Requirements In general, each owner or operator of a public water system is required to give notice of each of the following to the persons served by the system [Sec. 1414(c)(1)]: 1. any failure on the part of the public water system to comply with an applicable MCL or treatment technique requirement of, or a testing procedure prescribed by, an NPDWR, or to perform monitoring required by Section 1445(a); 2. the existence of the variance or exemption, and any failure to comply with the requirements of any variance or exemption schedule, and 3. the concentration of any unregulated contaminant for which USEPA has required public notice. General SDWA requirements for public notification are summarized in Table C.4.

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SECTION-BY-SECTION SUMMARY OF THE SDWA

TABLE C.4 SDWA Public Notification Criteria Condition Any violation with potential to have serious adverse effects on human health Violations without potential to have serious adverse effects on human health Concentrations of unregulated contaminants

SDWA Requirement Notice must be given as soon as possible, but no later than 24 hours after the occurrence of the violation Notice at least annually Notice may be required

Form, Manner, and Frequency of Notice After consultation with the states, USEPA is required to issue regulations by regulation, and after consultation with the states, prescribe the manner, frequency, form, and content for giving notice [Sec. 1414(c)(2)]. The regulations must 1. Provide for different frequencies of notice on the basis of the differences between violations that are intermittent or infrequent and violations that are continuous or frequent. 2. Take into account the seriousness of any potential adverse health effects that may be involved.

State Requirements States may establish alternative notification requirements with respect to the form and content of notices [Sec. 1414(c)(2)(B)]. The alternative requirements must provide the same type and amount of information as required by USEPA regulations.

Violations with Potential to Have Serious Adverse Effects on Human Health Notification procedures for each violation by a public water system that has the potential to have serious adverse effects on human health as a result of short-term exposure must be specified by USEPA [Sec. 1414(c)(2)(C)]. Each notice of a serious violation must 1. Be distributed as soon as practicable after the occurrence of the violation, but no later than 24 hours after the occurrence of the violation 2. Provide a clear and readily understandable explanation of the violation, the potential adverse effects on human health, the steps that the public water system is taking to correct the violation, and the necessity of seeking alternative water supplies until the violation is corrected 3. Be provided to USEPA or the head of the state primacy agency as soon as practicable, but no later than 24 hours after the occurrence of the violation

SECTION 1414—ENFORCEMENT OF DRINKING WATER REGULATIONS

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4. As required by the state agency in general regulations of the state agency, or on a case-by-case basis after the consultation, considering the health risks involved, be provided to appropriate broadcast media, be prominently published in a newspaper of general circulation serving the area no later than one day after distribution of the public notice or the date of publication of the next issue of the newspaper, or be provided by posting or door-to-door notification in lieu of notification by means of broadcast media or newspaper Written Notice USEPA regulations are to specify notification procedures for violations other than violations with the potential to have serious adverse effects, which are covered by Section 1414(c)(2)(C). The procedures must require public water systems to provide written notice to each person served by the system by notice in the first bill (if any) prepared after the date of occurrence of the violation, in an annual report issued no later than one year after the date of occurrence of the violation, or by mail or direct delivery as soon as practicable, but no later than one year after the date of occurrence of the violation. USEPA regulations are to prescribe the form and manner of the notice to provide a clear and readily understandable explanation of the violation, any potential adverse health effects, and the steps that the system is taking to seek alternative water supplies, if any, until the violation is corrected. USEPA may require the owner or operator of a public water system to give notice to the persons served by the system of the concentration levels of an unregulated contaminant required to be monitored under Section 1445(a). Reports No later than Jan. 1, 1998, and annually thereafter, each primacy state is required to prepare an annual report on violations of NPDWRs by public water systems in the state [Sec. 1414(c)(3)]. The report is to be made readily available to the public and submitted to USEPA. It is to include violations with respect to MCLs, treatment requirements, variances and exemptions, and monitoring requirements determined to be significant by USEPA after consultation with the states. States are required to publish and distribute summaries of the report and indicate where the full report is available for review. No later than July 1, 1998, and annually thereafter, USEPA is required to prepare and make available to the public an annual report summarizing and evaluating reports submitted by the states and notices submitted by public water systems serving Indian tribes [Sec. 1414(c)(3)]. Recommendations concerning resources needed to improve compliance with the SDWA are to be included in USEPA’s report. The report is to include information about public water system compliance on Indian reservations and about enforcement activities undertaken and financial assistance provided by USEPA on Indian reservations, and is to include specific recommendations concerning the resources needed to improve compliance with the SDWA on Indian reservations.

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SECTION-BY-SECTION SUMMARY OF THE SDWA

Consumer Confidence Reports The 1996 amendments added Section 1414(c)(4) to require each community water system to mail to each customer of the system at least once annually a report referred to as a consumer confidence report, on the level of contaminants in the drinking water purveyed by that system. USEPA Regulations USEPA is required to issue regulations requiring consumer confidence reports within 24 months after the date of enactment (Aug. 6, 1998) [Sec. 1414(c)(4)]. The agency must consult with public water systems, environmental groups, public interest groups, risk communication experts, the states, and other interested parties in developing these regulations. The regulations are to provide a brief and plainly worded definition of the terms maximum contaminant level goal, maximum contaminant level, variances, and exemptions and brief statements in plain language regarding the health concerns that resulted in regulation of each regulated contaminant. A brief and plainly worded explanation regarding contaminants that may reasonably be expected to be present in drinking water, including bottled water, must also be included. A USEPA toll-free hotline that consumers can call for more information and explanation is required. Contents of Consumer Confidence Reports The SDWA specifies that consumer confidence reports include at least each of the following [Sec. 1414(c)(4)(B)]: 1. Information on the source of the water purveyed. 2. A brief and plainly worded definition of the terms maximum contaminant level goal, maximum contaminant level, variances, and exemptions as provided in USEPA regulations. 3. If any regulated contaminant is detected in the water purveyed by the public water system, a statement setting forth the MCLG, the MCL, the level of the contaminant in the water system, and for any regulated contaminant for which there has been a violation of the MCL during the year concerned, a brief statement in plain language regarding the health concerns that resulted in regulation of the contaminant, as provided in USEPA regulations 4. Information on compliance with NPDWRs, as required by USEPA, and notice if the system is operating under a variance or exemption and the basis on which the variance or exemption was granted. 5. Information on the levels of unregulated contaminants for which monitoring is required under Section 1445(a)(2) (including levels of Cryptosporidium and radon when states determine they may be found). 6. A statement that the presence of contaminants in drinking water does not necessarily indicate that the drinking water poses a health risk and that more

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information about contaminants and potential health effects can be obtained by calling the USEPA hotline. The public water system may include additional information as it deems appropriate for public education. USEPA may, for not more than three regulated contaminants other than regulated contaminants for which there has been a violation of the MCL during the year concerned, require a consumer confidence report to include the brief statement in plain language regarding the health concerns that resulted in regulation of the contaminant or contaminants concerned, as provided by USEPA [Sec. 1414(c)(4)(B)]. Governor Determination for Small Systems The governor of a state may determine not to apply the direct mailing requirement to a community water system serving fewer than 10,000 persons. These systems must 1. Inform, in the newspaper notice mentioned in item 3 below or by other means, its customers that the system will not be mailing the report. 2. Make the consumer confidence report available on request to the public. 3. Publish the report annually in one or more local newspapers serving the area in which customers of the system are located. A community water system not required to meet the direct mailing requirement and serving 500 persons or fewer may elect not to comply with item 1 or 3 above. If the community water system so elects, at a minimum the system is required to 1. Prepare an annual consumer confidence report. 2. Provide notice at least once per year to each of its customers by mail, by doorto-door delivery, by posting, or by other means authorized by USEPA, regulations that the consumer confidence report is available on request. State Flexibility Primacy states may establish, by rule, after notice and public comment, alternative requirements with respect to the form and content of consumer confidence reports. National Secondary Regulations Section 1414(d) directs USEPA to notify the state if one or more systems in the state does not comply with a national secondary regulation within a reasonable time after promulgation if it appears that the noncompliance is a result of failure of the state to take reasonable action. Although national secondary regulations are not enforceable at the federal level, the intent of the SDWA is that systems comply with secondary regulations and some states have adopted them as enforceable state regulations.

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SECTION-BY-SECTION SUMMARY OF THE SDWA

Federal Preemption Section 1414(e) states that the authority of a state or political subdivision to adopt or enforce its own laws or regulations for drinking water or public water systems is not diminished. States or political subdivisions may establish their own laws and regulations, but the requirements of the SDWA regulations must also be met. Federal Assistance Section 1414(f) provides authority for the administrator to assist a public water system that is in noncompliance. A public hearing is held to gather information on ways to bring the system into compliance and how to protect public health during the period of noncompliance. On the basis of the hearing, the administrator issues recommendations to the state and the public water system, and the recommendations are also made available to the public and the communications media. A state, public water system, or persons served by a system petition the administrator for assistance under this provision of the SDWA. Administrative Orders Under Section 1414(g) USEPA can issue administrative orders to public water systems that are in violation of any applicable SDWA requirement. This allows the agency to take swift enforcement action because orders can be issued by the regional offices without having to go through a U.S. district court. USEPA can issue orders for violations in primacy and nonprimacy states. In a primacy state, USEPA must notify both the state and the public water system of the violation. The state has 30 days after this notice to act. If it does not, USEPA must then issue an order or take civil court action. The public water supply or its consumers can request a public hearing before the order takes effect. Any person who violates or fails or refuses to comply with an administrative order is liable to the United States for civil penalty of no more than $25,000 per day of violation. Civil penalties not exceeding $5000 can be assessed by USEPA after notice and opportunity for a public hearing (unless the person against whom the penalty is assessed requests a hearing on the record in accordance with Section 554 of Title 5, United States Code). Civil penalties exceeding $5000, but not exceeding $25,000, must be assessed by USEPA after notice and opportunity for a hearing on the record in accordance with Section 554 of Title 5, United States Code. Civil penalties exceeding $25,000 must be assessed by a civil action brought by USEPA in the appropriate U.S. district court (as determined under the provisions of Title 28 of the United States Code). If any person fails to pay an assessment of a civil penalty after it has become a final and unappealable order, or after the appropriate court of appeals has entered final judgment in favor of USEPA, the attorney general is required to recover the amount for which the person is liable in any appropriate district court of the United States. In taking this action, the validity and appropriateness of the final order imposing the civil penalty is not subject to review.

SECTION 1415—VARIANCES

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Consolidation Incentive The 1996 SDWA amendments provide an incentive for consolidation. No enforcement action can be taken against a system with an approved consolidation plan. The plan must be submitted by the owner or operator of a public water system to the primacy agency for approval. It must include specific measures and schedules for [Sec. 1414(h)]  the physical consolidation of the system with one or more other systems;  the consolidation of significant management and administrative functions of the system with one or more other systems; or  the transfer of ownership of the system that may reasonably be expected to improve drinking water quality. If the primacy agency approves the plan, no enforcement action can be taken with respect to a specific violation identified in the approved plan prior to the date that is the earlier of the date on which consolidation is completed according to the plan or the date that is two years after the plan is approved. SECTION 1415—VARIANCES Section 1415 authorizes primacy states and USEPA in states not having primacy to issue variances. To receive a variance, a public water system must demonstrate that the characteristics of its water source prevent compliance with an NPDWR. A variance can be issued only after the system has agreed to install the BAT, treatment methods, or other means that USEPA determines are available. In addition, an evaluation satisfactory to the state must be conducted and find that alternative sources of water are not reasonably available to the system. USEPA must publish the BAT and treatment methods for each NPDWR that is proposed or promulgated, and the methods can vary depending on the size of the system and conditions relating to costs and engineering. In other words, USEPA can devise separate criteria for small systems or any system where a particular treatment method is not practical. Regardless of the criteria, the variance cannot result in an unreasonable risk to health. When a variance is granted, a schedule that outlines progressive steps toward compliance must also be issued. The schedule must contain additional control measures that the system must take to protect public health. Even though a treatment plant is not achieving the required degree of treatment when operating under a variance, it must be kept in operation. The public water system cannot simply give up and turn the treatment plant off if an NPDWR cannot be met. Variances are granted by contaminant, and continued plant operation is necessary to meet NPDWRs not covered by the variance. Small System Variances The 1996 SDWA amendments added Section 1415(e) providing for small system variances. The primacy agency may grant a variance for compliance with a requirement specifying an MCL or treatment technique to

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SECTION-BY-SECTION SUMMARY OF THE SDWA

1. Public water systems serving 3300 or fewer persons. 2. With the approval of USEPA, public water systems serving more than 3300 persons but fewer than 10,000 persons. A public water system may receive a variance if 1. USEPA has identified a variance technology under Section 1412(b)(15) that is applicable to the size and source water quality conditions of the public water system. 2. The public water system installs, operates, and maintains, in accordance with guidance or regulations issued by USEPA, such treatment technology, treatment technique, or other means. 3. The state in which the system is located determines that the following conditions are met: (A) The system cannot afford to comply, in accordance with affordability criteria established by the primacy agency, with an NPDWR, including compliance through treatment, alternative source of water supply, restructuring or consolidation (unless the primacy agency makes a written determination that restructuring or consolidation is not practicable), (B) The primacy agency determines that the terms of the variance ensure adequate protection of human health, considering the quality of the source water for the system and the removal efficiencies and expected useful life of the treatment technology required by the variance. A small system variance must require compliance with the conditions of the variance no later than 3 years after the date on which the variance is granted, except that the primacy agency may allow up to 2 additional years to comply with a variance technology, secure an alternative source of water, restructure or consolidate if the primacy agency determines that additional time is necessary for capital improvements, or to allow for financial assistance provided pursuant to Section 1452 or any other federal or state program. The primacy agency is required to review each variance granted not less often than every 5 years after the compliance date established in the variance to determine whether the system remains eligible for the variance and is conforming to each condition of the variance. Small system variances may not be granted for 1. any MCL or treatment technique for a contaminant that was regulated prior to Jan. 1, 1986; or 2. an NPDWR for a microbial contaminant (including a bacterium, virus, or other organism) or an indicator or treatment technique for a microbial contaminant.

SECTION 1415—VARIANCES

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No later than 2 years after enactment (Aug. 6, 1996) and in consultation with the states, USEPA is required to promulgate regulations for small system variances. The regulations will specify, at a minimum, the following: 1. Procedures to be used by the primacy agency to grant or deny variances, including requirements for notifying USEPA and consumers of the public water system that a variance is proposed to be granted (including information regarding the contaminant and variance) and requirements for a public hearing on the variance before the variance is granted. 2. Requirements for the installation and proper operation of variance technology that is identified under Section 1412(b)(15) for small systems and the financial and technical capability to operate the treatment system, including operator training and certification. 3. Eligibility criteria for a variance for each NPDWR, including requirements for the quality of the source water [under Sec. 1412(b)(15)(A)]. 4. Information requirements for variance applications. No later than Feb. 6, 1998, USEPA, in consultation with the states and the Rural Utilities Service of the Department of Agriculture, is required to publish information to assist the states in developing affordability criteria. States are required to review the affordability criteria no less often than every 5 years to determine if changes are needed to the criteria. USEPA is required to periodically review the program of each primacy state with respect to variances to determine whether the variances granted by the state comply with the applicable requirements. With respect to affordability, USEPA’s determination is limited to whether the variances granted by the state comply with the affordability criteria developed by the state. If USEPA determines that variances granted by a state are not in compliance with affordability criteria developed by the state and other applicable requirements, USEPA is required to notify the state in writing of the deficiencies and make public the determination. A state proposing to grant a small system variance to a public water system serving more than 3300 and fewer than 10,000 persons is required to submit the variance to USEPA for review and approval prior to the issuance of the variance. USEPA is required to approve the variance if it meets each of the applicable requirements. USEPA must approve or disapprove the variance within 90 days. If the variance is disapproved, USEPA is required to notify the state in writing of the reasons for disapproval and the variance may be resubmitted with modifications to address the objections stated by the agency. USEPA may review and object to any variance proposed to be granted by a state if the objection is communicated to the state no later than 90 days after the state proposes to grant the variance. If USEPA objects to the granting of a variance, the agency is required to notify the state in writing of each basis for the objection and propose a modification to the variance to resolve the concerns of the agency. The state is required to make the recommended modification or respond in writing to

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each objection. If the state issues the variance without resolving USEPA’s concerns, USEPA may overturn the state’s decision to grant the variance. No later than 30 days after a primacy state proposes to grant a variance for a public water system, any person served by the system may petition USEPA to object to the granting of a variance. USEPA is required to respond to the petition and determine whether to object to the variance no later than 60 days after the receipt of the petition. No variance can be granted by a state until the later of the following: 1. Ninety days after the state proposes to grant a variance. 2. If USEPA objects to the variance, the date on which the state makes the recommended modifications or responds in writing to each objection.

SECTION 1416—EXEMPTIONS Public water systems can obtain exemptions if they show compelling factors for noncompliance with an NPDWR. The system must be in operation as of the effective date of the particular regulation, and an exemption must not cause an unreasonable risk to health (Sec. 1416). A compliance schedule must be issued at the same time the exemption is granted. Compliance is required as expeditiously as practicable, but no later than 3 years after the otherwise applicable compliance date established in Section 1412(b)(10). Before receiving an exemption, a public water system must take all practicable steps to meet the standard and establish that the system cannot meet the standard without capital improvements that cannot be completed prior to the compliance data set under Section 1412(b)(10) financial assistance is necessary and an agreement has been entered into to obtain such assistance, or State Revolving Loan Fund (SRLF) or other assistance is reasonably likely to be available within the period of the exemption; or an enforceable agreement has been entered into to become part of a regional public water system. The 1996 SDWA amendments provide that systems serving not more than 3300 persons may renew an exemption if they are taking all practical steps and need financial assistance. Exemptions are limited to a total of 6 years. A water system cannot receive an exemption if it has received a variance.

SECTION 1417—PROHIBITION ON USE OF LEAD PIPES, SOLDER, AND FLUX Section 1417 was added to the SDWA by the 1986 amendments to decrease future problems of lead contamination in water systems. The section was amended in 1996 to expand coverage to include the use of leaded plumbing fittings and fixtures (faucets).

SECTION 1418—MONITORING OF CONTAMINANTS

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No person may use any pipe, any pipe or plumbing fitting or fixture, any solder, or any flux, after June 19, 1986, in the installation or repair of any public water system, or any plumbing in a residential or nonresidential facility providing water for human consumption, that is not ‘‘lead free.’’ ‘‘Lead free’’ is defined to mean that solder and flux can contain no more than 0.2% lead; pipes and fittings not more than 8.0%; and plumbing fittings and fixtures must comply with voluntary standards required under the act. Leaded joints required for the repair of cast iron mains are not included. Public water systems were required to identify and provide notice to anyone who may be affected by lead contamination caused by lead content of materials used in the distribution or plumbing systems or caused by the corrosivity of the water, which may cause leaching of lead. This notice was to be given even if the system was in compliance with the MCL for lead. States were required to start enforcement of this prohibition and the public notice requirements by June 1988. If a state refused, USEPA could reduce that state’s program grant by as much as 5%.

SECTION 1418—MONITORING OF CONTAMINANTS The 1996 amendments added Section 1418 to provide for monitoring relief and alternative monitoring programs. Interim Monitoring Relief Section 1418(a) authorizes primacy states to modify the monitoring requirements for any regulated or unregulated contaminants for which monitoring is required other than microbial contaminants (or indicators thereof), disinfectants and disinfection byproducts or corrosion byproducts for an interim period. This interim monitoring relief applies to public water systems serving 10,000 persons or less. These systems will not be required to conduct additional quarterly monitoring during an interim relief period for certain contaminants if 1. monitoring conducted at the beginning of the period for the contaminant concerned and certified to the state by the public water system fails to detect the presence of the contaminant in the groundwater or surface water supplying the public water system; and 2. the state, considering the hydrogeology of the area and other relevant factors, determines in writing that the contaminant is unlikely to be detected by further monitoring during the period. Interim relief terminates when permanent monitoring relief is adopted and approved for the state, or at the end of 36 months after the date of enactment (Aug. 6, 1999), whichever comes first. In order to serve as a basis for interim relief, the monitoring conducted at the beginning of the period must occur at the time determined by the state to be the time of the public water system’s greatest

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vulnerability to the contaminant concerned in the relevant groundwater or surface water, taking into account in the case of pesticides the time of application of the pesticide for the source water area and the travel time for the pesticide to reach the source waters and taking into account, in the case of other contaminants, seasonality of precipitation and contaminant travel time.

Permanent Monitoring Relief Section 1418(b) allows for permanent monitoring relief. Primacy states having an approved source water assessment program may adopt, in accordance with USEPA guidance, tailored alternative monitoring requirements for public water systems in the state. These requirements are to be an alternative to the monitoring requirements for chemical contaminants set forth in the applicable NPDWRs. The state must conclude, based on data available at the time of adoption concerning susceptibility, use, occurrence, or wellhead protection, or from the state’s drinking water source water assessment program, that the alternative monitoring would provide assurance that it complies with USEPA’s guidelines. The state program must be adequate to ensure compliance with, and enforcement of, applicable NPDWRs. Alternative monitoring does not apply to regulated microbiological contaminants (or indicators thereof), disinfectants and disinfection byproducts, or corrosion byproducts.

USEPA Guidelines USEPA is required to issue guidelines for states to follow in proposing alternative monitoring requirements for chemical contaminants. These guidelines are to be submitted for public comment and developed at the same time as guidelines are issued for source water assessment under Section 1453. USEPA is required to publish the guidelines in the Federal Register. The guidelines must ensure that public health will be protected from drinking water contamination. State alternative monitoring programs will apply on a contaminant-by-contaminant basis. To be eligible for the alternative monitoring program, a public water system must show the state that the contaminant is not present in the drinking water supply or, if present, it is reliably and consistently below the maximum contaminant level. The phrase ‘‘reliably and consistently below the maximum contaminant level’’ means that, although contaminants have been detected in a water supply, the state has sufficient knowledge of the contamination source and extent of contamination to predict that the MCL will not be exceeded. In determining that a contaminant is reliably and consistently below the MCL, states must consider the quality and completeness of data, the length of time covered and the volatility or stability of monitoring results during that time, and the proximity of the results to the MCL. Wide variations in the analytical results, or analytical results close to the MCL will not be considered to be reliably and consistently below the MCL.

SECTION 1419—OPERATOR CERTIFICATION

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If a contaminant covered by the alternative monitoring program is detected at levels at or above the MCL or is no longer reliably or consistently below the MCL, the public water system must either  demonstrate that the contamination source has been removed or that other action has been taken to eliminate the contamination problem, or  test for the detected contaminant as required by the applicable NPDWR. Nonprimacy States Section 1418(b)(4) allows the governor of any state not exercising primacy on the date of enactment (Aug. 6, 1996) to submit to USEPA a request that the agency modify the monitoring requirements established by USEPA and applicable to public water systems in that state. After consultation with the governor, USEPA is required to modify the requirements for public water systems in that state if the request of the governor is in accordance with each of the requirements of Section 1418 that apply to alternative monitoring requirements established by primacy states. A decision by USEPA to approve a request is for a period of 3 years and may subsequently be extended for periods of 5 years. Treatment as an NPDWR All monitoring relief (interim or permanent) granted by a state to a public water system for a regulated contaminant is treated as part of the NPDWR for that contaminant [Sec. 1418(c)]. Other Monitoring Relief Section 1418(d) ensures that states are allowed to exercise the authority under applicable NPDWRs to alter monitoring requirements through waivers or other existing authorities. USEPA is required to periodically review and, as appropriate, revise these authorities.

SECTION 1419—OPERATOR CERTIFICATION The 1996 amendments added Section 1419 regarding operator certification. USEPA Guidelines Section 1419(a) requires USEPA to develop guidelines specifying minimum standards for certification and recertification of operators of community and nontransient noncommunity water systems. The guidelines will take into account existing state programs, the size of the system, the complexity of the system, and other factors

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aimed at providing an effective program at reasonable cost to states and public water systems. The guidelines must be issued for public comment from interested persons, including states and public water systems, and published in the Federal Register no later than Feb. 6, 1999. SRLF Withholding Section 1419(b) requires USEPA to withhold 20% of the state SRLF allotment unless the state has adopted and is implementing an operator certification program for operators of community and nontransient noncommunity public water systems. This provision takes effect beginning two years after publication of USEPA’s operator certification guidelines. State programs must either meet USEPA guidelines or have an existing program that has been submitted for approval and that has not been disapproved (see the following). Existing State Programs States will be allowed under Section 1419(c) to enforce existing programs in lieu of USEPA’s guidelines. The state will be required to submit the existing program to USEPA within 18 months after the publication of USEPA’s guidelines. USEPA must determine within 9 months after the state submits the program that the program is substantially equivalent to USEPA’s guidelines. In making this determination, an existing state program will be presumed to be substantially equivalent to the guidelines, based on the size of systems or the quality of source water, providing the state program meets the overall public health objectives of USEPA’s guidelines. If disapproved, the state may resubmit the program within six months after receipt of notice of disapproval. Cost Reimbursement Section 1419(d) requires USEPA to provide reimbursement for the costs of training, including an appropriate per diem for unsalaried operators, and certification for persons operating systems serving 3300 persons or fewer that are required to undergo training. The reimbursement will be provided through grants to states with each state receiving an amount sufficient to cover the reasonable costs for training all operators in the state, as determined by USEPA. Grants received by a state will first be used to provide reimbursement for training and certification costs of persons operating systems serving 3300 persons or fewer. If a state has reimbursed all such costs, the state may, after notice to USEPA, use any remaining funds from the grant for any of the other purposes authorized for SRLF grants under Section 1452. Funding Authorization Section 1419(d)(3) authorizes to be appropriated to USEPA $30,000,000 for each of fiscal years 1997 through 2003 to provide grants for operator training reimbursement. If the appropriation for any fiscal year is not sufficient to cover the full cost of

SECTION 1420—CAPACITY DEVELOPMENT

677

reimbursement, then USEPA is required to reserve appropriated SRLF sums as necessary to provide reimbursement for the training and certification costs prior to making any other SRLF allocation or reservation.

SECTION 1420—CAPACITY DEVELOPMENT The 1996 amendments added Section 1420 establishing requirements for capacity development programs and activities.

Authority for New Systems A state will receive only 80% of the SRLF allotment that the state is otherwise entitled to receive under Section 1452 unless the state has obtained the legal authority or other means to ensure that all new community water systems and new nontransient, noncommunity water systems commencing operation after Oct. 1, 1999, demonstrate technical, managerial, and financial capacity with respect to each national primary drinking water regulation in effect, or likely to be in effect, on the date of commencement of operations [Sec. 1420(a)].

Significant Noncompliance Beginning no later than Aug. 6, 1997, each state is required to prepare, periodically update, and submit to USEPA a list of community water systems and nontransient, noncommunity water systems that have a history of significant noncompliance with the SDWA and, to the extent practicable, the reasons for noncompliance [Sec. 1420(b)]. No later than Aug. 6, 2001, and as part of the capacity development strategy of the state, each state must report to USEPA on the success of enforcement mechanisms and initial capacity development efforts in assisting the public water systems in significant noncompliance to improve technical, managerial, and financial capacity. The list and report is considered part of the required capacity development strategy of the state for purposes of the SRLF withholding requirements of Section 1452(a)(I)(G)(i).

Capacity Development Strategy Section 1420(c) provides that beginning Aug, 6, 2000, a state will receive only  90% in fiscal year 2001,  85% in fiscal year 2002, and  80% in each subsequent fiscal year,

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of the SRLF allotment that the state is otherwise entitled to receive under Section 1452, unless the state is developing and implementing a strategy to assist public water systems in acquiring and maintaining technical, managerial, and financial capacity. In preparing the capacity development strategy, the states must consider, solicit public comment on, and include as appropriate the following in preparing a capacity development strategy:  the methods or criteria that the state will use to identify and prioritize the public water systems most in need of improving technical, managerial, and financial capacity;  a description of the institutional, regulatory, financial, tax, or legal factors at the federal, state, or local level that encourage or impair capacity development;  a description of how the state will use the authorities and resources of this title or other means to assist public water systems in complying with national primary drinking water regulations; encourage the development of partnerships between public water systems to enhance the technical, managerial, and financial capacity of the systems; and assist public water systems in the training and certification of operators;  a description of how the state will establish a baseline and measure improvements in capacity with respect to national primary drinking water regulations and state drinking water law; and  an identification of the persons that have an interest in and are involved in the development and implementation of the capacity development strategy (including all appropriate agencies of federal, state, and local governments, private and nonprofit public water systems, and public water system customers). No later than 2 years after the date on which a state first adopts a capacity development strategy, and every 3 years thereafter, the head of the state primacy agency must submit to the governor a report on the efficacy of the strategy and progress made toward improving the technical, managerial, and financial capacity of public water systems in the state. The report is also to be made available to the public. The decisions of the state regarding any particular public water system are not subject to review by USEPA and may not serve as the basis for withholding funds under Section 1452.

Federal Assistance USEPA is required to support the states in developing capacity development strategies. No later than 180 days after enactment (Feb. 3, 1997), USEPA must

SECTION 1420—CAPACITY DEVELOPMENT

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 conduct a review of state capacity development efforts in existence on the date of enactment of this section and publish information to assist states and public water systems in capacity development efforts; and  initiate a partnership with states, public water systems, and the public to develop information for states on recommended operator certification requirements. (USEPA is required to publish the information developed through the partnership no later than Feb. 6, 1998.) In promulgating an NPDWR, USEPA is required to include an analysis of the likely effect of compliance with the regulation on the technical, financial, and managerial capacity of public water systems. No later than Aug. 6, 1998, USEPA is required to publish guidance developed in consultation with the states describing legal authorities and other means to ensure that all new community water systems and new nontransient, noncommunity water systems demonstrate technical, managerial, and financial capacity with respect to national primary drinking water regulations. Variances and Exemptions On the basis of information obtained from the state reports, USEPA is required, as appropriate, to modify regulations concerning variances and exemptions for small public water systems to ensure flexibility in the use of the variances and exemptions. This provision does not affect or alter the requirements of Section 1415 or Section 1416. Small Public Water Systems Technology Assistance Centers Section 1420(f) authorizes USEPA to make grants to institutions of higher learning to establish and operate small public water system technology assistance centers in the United States. The responsibilities of the centers are to include training and technical assistance relating to the information, performance, and technical needs of small public water systems or public water systems that serve Indian tribes. Any institution of higher learning interested in receiving a grant to establish a center must submit an application to USEPA. USEPA is to select recipients of grants on the basis of the following criteria:  The small public water system technology assistance center must be located in a state that is representative of the drinking water needs of small and rural communities or Indian tribes of the region in which the state is located.  The grant recipient must be located in a region that has experienced problems, or may reasonably be foreseen to experience problems, with small and rural public water systems.  The grant recipient must have access to expertise in small public water system technology management.

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SECTION-BY-SECTION SUMMARY OF THE SDWA

 The grant recipient shall have the capability to disseminate the results of small public water system technology and training programs.  The projects that the grant recipient proposes to carry out under the grant are necessary and appropriate.  The grant recipient has regional support beyond the host institution.  At least two of the grants must be issued to a consortia of states with low population densities. There are authorized to be appropriated grants of $2,000,000 for each of the fiscal years 1997 through 1999 and $5,000,000 for each of the fiscal years 2000 through 2003. Environmental Finance Centers Section 1420(g) requires USEPA to provide initial funding for one or more university-based environmental finance centers for activities that provide technical assistance to state and local officials in developing the capacity of public water systems. Funds may be used only for activities that are directly related to the SDWA. USEPA is required to establish a national public water system capacity development clearinghouse to receive and disseminate information with respect to developing, improving, and maintaining financial and managerial capacity at public water systems. The agency must ensure that the clearinghouse does not duplicate other federally supported clearinghouse activities. USEPA is authorized to request an environmental finance center to develop and test managerial, financial, and institutional techniques for capacity development. The techniques may include capacity assessment methodologies, manual and computerbased public water system rate models and capital planning models, public water system consolidation procedures, and regionalization models. Authorized appropriations to carry out this provision include $1,500,000 for each of the fiscal years 1997 through 2003. No portion of any funds made available may be used for lobbying expenses.

SECTION 1421—REGULATIONS FOR STATE PROGRAMS Section 1421 requires USEPA to establish regulations for state underground injection control (UIC) programs. The SDWA specifies minimum program requirements in Section 1421(b), including assurance that injections will not endanger drinking water sources. Regulations may not interfere with or impede the underground injection of brine or other fluids brought to the surface in connection with oil or natural gas production, natural gas storage, or injections for secondary or tertiary recovery of oil or natural gas, unless requirements are essential to ensure that underground sources of drinking water will not be endangered by the injection. Issuance of temporary permits is authorized under certain circumstances [Sec. 1421(c)].

SECTION 1422—STATE PRIMARY ENFORCEMENT RESPONSIBILITY

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Key definitions are provided in Section 1421(d). ‘‘Underground injection’’ is ‘‘the subsurface emplacement of fluids by well injection.’’ It does not include injection of natural gas for subsurface storage. The SDWA specifies that ‘‘underground injection endangers drinking water sources if such injection may result in the presence in underground water which supplies or can reasonably be expected to supply any public water system of any contaminant, and if the presence of such contaminant may result in such system’s not complying with any NPDWR or may otherwise adversely affect the health of persons’’ [Sec. 1421(d)(2)].

SECTION 1422—STATE PRIMARY ENFORCEMENT RESPONSIBILITY Section 1422 authorizes states to assume primary enforcement responsibility (primacy) for the UIC program. States must meet requirements set by USEPA to retain primacy. Indian tribes may also assume primacy for UIC programs.

SECTION 1423—ENFORCEMENT OF PROGRAM Section 1423(a) authorizes USEPA to take action against any person who is subject to UIC regulations and is found in violation of any requirement. A notice of violation must be issued to the person violating the requirement and the primacy agency. If after the 30th day after the notice of violation the state has not taken enforcement action, the administrator may issue an administrative order or commence a civil action in the appropriate U.S. district court. Any person found in violation of any UIC program requirement or an administrative order is subject to a civil penalty of not more than $25,000 for each day of violation. In the case of willful violations, the violator may be imprisoned for not more than 3 years or receive additional fines in addition to or in place of a civil penalty.

SECTION 1424—INTERIM REGULATION OF UNDERGROUND INJECTION The 1974 SDWA allowed for interim regulation until UIC programs were first established (Sec. 1424). Its provisions are no longer applicable, except for Section 1424(e) concerning sole source aquifers. If USEPA determines that an area has an aquifer that is the sole or principal drinking water source for the area and that, if the aquifer were contaminated, it would create a significant hazard to public health, a notice of determination must be published in the Federal Register. Following publication of the notice, no commitment for federal financial assistance (grants, contracts, loan guarantees, or otherwise) may be entered into for any project that may contaminate the aquifer through a recharge zone so as to create a significant hazard to public health. If authorized under another provision of law, a commitment for federal financial assis-

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tance may be entered into to plan or design the project to ensure that it will not contaminate the aquifer.

SECTION 1425—OPTIONAL DEMONSTRATION BY STATES RELATING TO OIL OR NATURAL GAS States have the option under Section 1425 to demonstrate to USEPA that an existing state program is effective in preventing underground injection that endangers drinking water sources. If adequate, USEPA may approve the state program and delegate primacy to the state until the agency determines that the demonstration is no longer valid.

SECTION 1426—REGULATION OF STATE PROGRAMS USEPA was required to modify regulations for Class I injection wells by December 1987 and submit a report to Congress no later than September 1987 concerning the results of required state surveys (Sec. 1426).

SECTION 1427—SOLE SOURCE AQUIFER DEMONSTRATION PROGRAM Section 1427 establishes procedures for development, implementation, and assessment of demonstration programs designed to protect critical aquifer protection areas designated as sole or principal source aquifers under Section 1424(e). A critical aquifer protection area is defined as either  all or part of an area located within an area for which an application or designation as a sole or principal source aquifer has been approved by USEPA, or  all or part of an area that is within an aquifer designated as a sole source aquifer under an approved area wide groundwater quality protection plan under Section 208 of the Clean Water Act. Any state, municipal, or local government or political subdivision or any planning entity may apply to USEPA for the selection of a critical aquifer protection area over which it has authority or jurisdiction for a demonstration program. Applications must meet certain criteria specified by USEPA under Section 1427(d) and (e) and must be jointly submitted by the governor. Applications must include a comprehensive management plan prepared under Section 1427(f) that is designed to maintain the quality of the groundwater in the

SECTION 1428—STATE PROGRAMS TO ESTABLISH WELLHEAD PROTECTION

critical protection area in a manner reasonably expected to protect human health, the environment, and groundwater resources.

SECTION 1428—STATE PROGRAMS TO ESTABLISH WELLHEAD PROTECTION AREAS The 1986 amendments added Section 1428, which provided for state programs intended specifically to protect groundwater supplying public water system wells. The programs protect wellhead areas from contaminants that could affect public health. States were required to submit a program to USEPA by June 1989. The program must  outline the roles of state, local, and public water supply agencies in carrying out the program,  determine wellhead protection areas for each well or well field supplying a public water system,  identify all potential anthropogenic contamination sources within each wellhead protection area,  describe a plan to protect the wells from contamination (this can include technical assistance, training, control measures, or financial assistance)  include contingency plans to provide safe drinking water in the event of a supply becoming contaminated, and  require that potential sources of contamination be investigated before a new well is constructed. A wellhead protection area is defined as the surface and subsurface area surrounding a well or well field supplying a public water supply through which contaminants could reach the well(s). The size of a particular area will be determined by the state using USEPA guidelines. Hydrogeological factors, such as radius of influence, which should be considered, will be outlined in these guidelines. States that submit programs were eligible to receive grants to cover 50–90% of the costs needed to develop and implement the program. No funding would be available for programs submitted after June 1989. If a state chose not to submit a program, USEPA would not implement a federal wellhead protection program. This differs from the public water supply and UIC programs.

SECTION 1429—STATE GROUNDWATER PROTECTION GRANTS The 1996 SDWA amendments established a new program whereby USEPA may make a grant to a state for the development and implementation of a state program to ensure the coordinated and comprehensive protection of groundwater resources within the state. USEPA is required by Aug. 6, 1997, and annually thereafter, to

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publish guidance that establishes procedures for application for state groundwater protection program assistance and that identifies key elements of state groundwater protection programs. Grants will be awarded to states that submit an application that is approved by USEPA. The amount of the grant will be awarded on the basis of an assessment of the extent of groundwater resources in the state and the likelihood that awarding the grant will result in sustained and reliable protection of groundwater quality. USEPA may also award a grant for innovative programs proposed by a state for the prevention of groundwater contamination. Grants may not be used for a project to remediate groundwater contamination. Grants must not exceed 50% of the eligible costs of carrying out the groundwater protection program that is the subject of the grant (as determined by USEPA) for the 1-year period beginning on the date that the grant is awarded. Each state with an approved program will receive at least 1% of funds made available to USEPA for this program. By Aug. 6, 1999, and every 3 years thereafter, USEPA was required to evaluate the state groundwater protection programs that are the subject of grants under this program and report to the Congress on the status of groundwater quality in the United States and the effectiveness of state programs for groundwater protection.

SECTION 1431—EMERGENCY POWERS The 1986 amendments expanded USEPA’s authority to act when an imminent threat to health is present (Sec. 1431). The authority was expanded in 2002 to include threatened or potential terrorist attack or other intentional act designed to disrupt the provision of safe drinking water or to impact adversely the safety of drinking water supplied to communities and individuals. USEPA can issue an order to anyone causing or contributing to contamination of a public water system and endangering public health. The order can require the provision of alternative, safe water supplies until the threat is over. The 1996 amendments increased the maximum penalty for violating an emergency order from $5000 per day to $15,000 per day.

SECTION 1432—TAMPERING WITH PUBLIC WATER SYSTEMS Section 1432 was added in 1986, making it a federal offense to tamper, attempt to tamper, or threaten to tamper with a public water system. Tamper is defined as ‘‘the introduction of a contaminant into a public water system or any interference with the operation of a public water system with the intent of harming persons.’’ Table C.5 indicates the substantial civil and criminal penalties that the court can impose under this provision, which were increased in 2002.

SECTION 1433—TERRORIST AND OTHER INTENTIONAL ACTS

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TABLE C.5 Penalties for Tempering with Public Water Systems Action

Civil Penalty

Criminal Penalty

Tampering

 $1,000,000 fine

Attempts or threats to tamper

 $100,000 fine

Prison sentence  20 years and=or fine in accordance with U.S. Code Prison sentence  10 years or fine in accordance with U.S. Code

SECTION 1433—TERRORIST AND OTHER INTENTIONAL ACTS This section was added in 2002 by the Public Water Security and Bioterrorism Preparedness and Response Act of 2002.

Vulnerability Assessments Each community water system serving a population of greater than 3300 persons is required to conduct an assessment of the vulnerability of its system to a terrorist attack or other intentional acts intended to substantially disrupt the ability of the system to provide a safe and reliable supply of drinking water. Vulnerability assessments are to include, but not be limited to, a review of pipes and constructed conveyances; physical barriers; water collection; pretreatment; treatment; storage and distribution facilities; electronic; computer, or other automated systems that are utilized by the public water system; the use, storage, or handling of various chemicals; and the operation and maintenance of such system. By August 1, 2002, after consultation with appropriate departments and agencies of the federal government and with state and local governments, USEPA is required to provide baseline information to community water systems required to conduct vulnerability assessments regarding which kinds of terrorist attacks or other intentional acts are the probable threats to  substantially disrupt the ability of the system to provide a safe and reliable supply of drinking water; or  otherwise present significant public health concerns. Community water systems required to conduct vulnerability assessments must certify to USEPA that the system has conducted an assessment complying with the requirements listed above and must submit to USEPA a written copy of the assessment. Certification and submission must be made prior to  March 31, 2003, in the case of systems serving a population of 100,000 or more.

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SECTION-BY-SECTION SUMMARY OF THE SDWA

 December 31, 2003, in the case of systems serving a population of 50,000 or more but less than 100,000.  June 30, 2004, in the case of systems serving a population greater than 3300 but less than 50,000. Except for information contained in a certification identifying the system submitting the certification and the date of the certification, all information provided to USEPA under this subsection and all information derived therefrom is exempt from disclosure under Section 552 of Title 5 of the United States Code. No community water system can be required under state or local law to provide an assessment to any state, regional, or local governmental entity solely by reason of the requirement that the system submit their assessment to USEPA. By November 30, 2002, USEPA, in consultation with appropriate federal law enforcement and intelligence officials, is required to develop protocols as may be necessary to protect the copies of the assessments submitted and the information contained therein from unauthorized disclosure. Such protocols shall ensure that  each copy of such assessment, and all information contained in or derived from the assessment, is kept in a secure location;  only individuals designated by USEPA may have access to the copies of the assessments; and  no copy of an assessment, or part of an assessment, or information contained in or derived from an assessment shall be available to anyone other than an individual designated by USEPA. At the earliest possible time prior to November 30, 2002, USEPA is to complete the development of the protocols for the purpose of having them in place prior to receiving any vulnerability assessments from community water systems. Any individual who acquires an assessment submitted to USEPA, or any reproduction of the assessment, or any information derived from the assessment, and who knowingly or recklessly reveals such assessment, reproduction, or information other than  to an individual designated by USEPA,  for purposes of Section 1445 or for actions under Section 1431, or  for use in any administrative or judicial proceeding to impose a penalty for failure to comply with this section, shall, on conviction, be imprisoned for not more than one year or fined in accordance with the provisions of Chapter 227 of Title 18, United States Code, applicable to Class A misdemeanors, or both, and shall be removed from Federal office or employment. An individual who is an officer or employee of the United States may discuss the contents of a vulnerability assessment submitted under this section with a state or

SECTION 1433—TERRORIST AND OTHER INTENTIONAL ACTS

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local official. Nothing in this section authorizes any person to withhold any information from Congress or from any committee or subcommittee of Congress.

Emergency Response Plan Each community water system serving a population greater than 3300 must prepare or revise, where necessary, an emergency response plan that incorporates the results of vulnerability assessments that have been completed. Each such community water system is required to certify to USEPA, as soon as reasonably possible after the enactment of this section, but not later than 6 months after the completion of the vulnerability assessment, that the system has completed their plan. The emergency response plan must include, but not be limited to, plans, procedures, and identification of equipment that can be implemented or utilized in the event of a terrorist or other intentional attack on the public water system. The emergency response plan is to also include actions, procedures, and identification of equipment that can obviate or significantly lessen the impact of terrorist attacks or other intentional actions on the public health and the safety and supply of drinking water provided to communities and individuals. Community water systems, to the extent possible, must coordinate with existing Local Emergency Planning Committees established under the Emergency Planning and Community Right-to-Know Act (42 USC 11001 et seq.) when preparing or revising an emergency response plan. Each community water system is required to maintain a copy of their emergency response plan for 5 years after the plan has been certified to USEPA. USEPA is to provide guidance to community water systems serving a population of less than 3300 persons on how to conduct vulnerability assessments, prepare emergency response plans, and address threats from terrorist attacks or other intentional actions designed to disrupt the provision of safe drinking water or significantly affect the public health or significantly affect the safety or supply of drinking water provided to communities and individuals. There are authorized to be appropriated to carry out this section not more than $160,000,000 for the fiscal year 2002 and such sums as may be necessary for the fiscal years 2003 through 2005. USEPA, in coordination with state and local governments, may use funds to provide financial assistance to community water systems for purposes of compliance with these requirements and to community water systems for expenses and contracts designed to address basic security enhancements of critical importance and significant threats to public health and the supply of drinking water as determined by a vulnerability assessment. Such basic security enhancements may include, but are not be limited to the following:    

The purchase and installation of equipment for detection of intruders. The purchase and installation of fencing, gating, lighting, or security cameras. The tamperproofing of manhole covers, fire hydrants, and valve boxes. The rekeying of doors and locks.

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SECTION-BY-SECTION SUMMARY OF THE SDWA

 Improvements to electronic, computer, or other automated systems and remote security systems.  Participation in training programs, and the purchase of training manuals and guidance materials, relating to security against terrorist attacks.  Improvements in the use, storage, or handling of various chemicals.  Security screening of employees or contractor support services. Funding for basic security enhancements can not include expenditures for personnel costs, or monitoring, operation, or maintenance of facilities, equipment, or systems. USEPA may use up to $5,000,000 to make grants to community water systems to assist in responding to and alleviating any vulnerability to a terrorist attack or other intentional acts intended to substantially disrupt the ability of the system to provide a safe and reliable supply of drinking water (including sources of water for such systems) that the Agency determines to present an immediate and urgent security need. USEPA may use up to $5,000,000 to make grants to community water systems serving a population of less than 3300 persons for activities and projects undertaken in accordance with USEPA guidance provided to these systems.

SECTION 1434—CONTAMINANT PREVENTION, DETECTION, AND RESPONSE This section was added in 2002 by the Public Water Security and Bioterrorism Preparedness and Response Act of 2002. USEPA, in consultation with the Centers for Disease Control and, after consultation with appropriate departments and agencies of the federal government and with state and local governments, is required to review (or enter into contracts or cooperative agreements to provide for a review of) current and future methods to prevent, detect, and respond to the intentional introduction of chemical, biological, or radiological contaminants into community water systems and source water for community water systems, including each of the following:  Methods, means, and equipment, including real-time monitoring systems, designed to monitor and detect various levels of chemical, biological, and radiological contaminants or indicators of contaminants and reduce the likelihood that such contaminants can be successfully introduced into public water systems and source water intended to be used for drinking water.  Methods and means to provide sufficient notice to operators of public water systems, and individuals served by such systems, of the introduction of chemical, biological, or radiological contaminants and the possible effect of such introduction on public health and the safety and supply of drinking water.

SECTION 1435—SUPPLY DISRUPTION PREVENTION, DETECTION, AND RESPONSE

689

 Methods and means for developing educational and awareness programs for community water systems.  Procedures and equipment necessary to prevent the flow of contaminated drinking water to individuals served by public water systems.  Methods, means, and equipment that could negate or mitigate deleterious effects on public health and the safety and supply caused by the introduction of contaminants into water intended to be used for drinking water, including an examination of the effectiveness of various drinking water technologies in removing, inactivating, or neutralizing biological, chemical, and radiological contaminants.  Biomedical research into the short-term and long-term impact on public health of various chemical, biological, and radiological contaminants that may be introduced into public water systems through terrorist or other intentional acts.

SECTION 1435—SUPPLY DISRUPTION PREVENTION, DETECTION, AND RESPONSE USEPA, in coordination with the appropriate departments and agencies of the federal government, is required to review (or enter into contracts or cooperative agreements to provide for a review of) methods and means by which terrorists or other individuals or groups could disrupt the supply of safe drinking water or take other actions against water collection, pretreatment, treatment, storage, and distribution facilities that could render water significantly less safe for human consumption, including each of the following:  Methods and means by which pipes and other constructed conveyances utilized in public water systems could be destroyed or otherwise prevented from providing adequate supplies of drinking water meeting applicable public health standards.  Methods and means by which collection, pretreatment, treatment, storage, and distribution facilities utilized or used in connection with public water systems and collection and pretreatment storage facilities used in connection with public water systems could be destroyed or otherwise prevented from providing adequate supplies of drinking water meeting applicable public health standards.  Methods and means by which pipes, constructed conveyances, collection, pretreatment, treatment, storage, and distribution systems that are utilized in connection with public water systems could be altered or affected so as to be subject to cross-contamination of drinking water supplies.  Methods and means by which pipes, constructed conveyances, collection, pretreatment, treatment, storage, and distribution systems that are utilized in

690

SECTION-BY-SECTION SUMMARY OF THE SDWA

connection with public water systems could be reasonably protected from terrorist attacks or other acts intended to disrupt the supply or affect the safety of drinking water.  Methods and means by which information systems, including process controls and supervisory control and data acquisition and cyber systems at community water systems could be disrupted by terrorists or other groups.  Methods and means by which alternative supplies of drinking water could be provided in the event of the destruction, impairment or contamination of public water systems. These reviews are to reflect the needs of community water systems of various sizes and various geographic areas of the United States. USEPA may consider the vulnerability of, or potential for forced interruption of service for, a region or service area, including community water systems that provide service to the national Capital area. USEPA is required to disseminate, as appropriate, to community water systems information on the results of the project through the Information Sharing and Analysis Center, or other appropriate means. There are authorized to be appropriated to carry out this section and Section 1434 not more than $15,000,000 for the fiscal year 2002 and such sums as may be necessary for the fiscal years 2003 through 2005.

SECTION 1441—ASSURANCE OF AVAILABILITY OF ADEQUATE SUPPLIES OF CHEMICALS NECESSARY FOR TREATMENT OF WATER Section 1441 authorizes USEPA to ensure that chemicals or substances necessary for water treatment are available. If a public water system determines that a chemical or substance necessary for treating water is not reasonably available or will not be available when needed for water treatment, the system applies to the administrator for a certification of need. If, after public notice and comment, the administrator finds that the needed chemical or substance is not available or will not be available when needed, the administrator issues a certification of need. No later than seven days following issuance of the certification, the president of the United States or the president’s delegate will issue an order requiring provision of the needed chemical or substance. The order can apply to manufacturers, producers, processors, distributors, or repackagers of the chemical or substance as the president or the president’s delegate deems necessary and appropriate, except those that manufacture, produce, or process the chemical or substance for their own use. Penalties of up to $2500 may be assessed for each failure to comply with the order, and in the case of willful violations, the penalties are doubled. Certifications of need and orders can remain in effect for no more than 1 year, at which time another application for certification of need must be submitted.

SECTION 1442—RESEARCH, TECHNICAL ASSISTANCE, INFORMATION, TRAINING

691

SECTION 1442—RESEARCH, TECHNICAL ASSISTANCE, INFORMATION, AND TRAINING OF PERSONNEL Section 1442 empowers USEPA to conduct research, technical assistance, and training. Several specific studies and reports are required and funding appropriations for these activities are authorized. Section 1442(a) gives USEPA broad authority to ‘‘conduct research, studies, and demonstrations related to the causes, diagnosis, treatment, control, and prevention of physical and mental diseases and other impairments of man resulting directly or indirectly from contaminants in water, or to the provision of a dependably safe supply of drinking water.’’ The following areas of research are specifically included in the statute:  Improved methods to identify and measure contaminants and to identify the source of the contaminants.  Improved methods to identify and measure the health effects of contaminants in drinking water.  New methods of water treatment.  Improved methods for providing a dependably safe supply of drinking water, including improvements in water purification and distribution, and methods of assessing the health-related hazards of drinking water.  Improved methods of protecting underground sources of public water systems from contamination. Section 1442(a)(2) authorizes USEPA to collect and make available information pertaining to research, investigations, and demonstrations with respect to providing a dependably safe supply of drinking water, together with appropriate recommendations in connection with the information; and make available research facilities of the agency to appropriate public authorities, institutions, and individuals engaged in studies and research relating to the SDWA. USEPA is authorized to provide technical assistance and to make grants to states or publicly owned water systems to alleviate any emergency situation that the agency determines to present a substantial danger to the public health [Sec. 1442(b)]. Section 1442(d) was revised in 2002 to authorize to be appropriated to carry out subsection (b) not more than $35,000,000 for the fiscal year 2002 and such sums as may be necessary for each fiscal year thereafter. The 1996 amendments added Section 1442(e) authorizing USEPA to provide technical assistance to small public water systems to enable these systems to achieve and maintain compliance with applicable NPDWRs. Assistance may include circuit-rider and multistate regional technical assistance programs, training, and preliminary engineering evaluations. USEPA must ensure that technical assistance is available in each state. Nonprofit organizations receiving assistance are required to consult with the state in which the assistance is to be expended or otherwise made

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SECTION-BY-SECTION SUMMARY OF THE SDWA

available before using assistance to undertake activities. There are authorized to be appropriated to USEPA for technical assistance $15,000,000 for each of the fiscal years 1997 through 2003. No portion of any funds made available may be used for lobbying expenses. Of the total amount appropriated, 3% must be used for technical assistance to public water systems owned or operated by Indian tribes.

SECTION 1443—GRANTS FOR STATE PROGRAMS The 1986 amendments extended USEPA’s authority to give grants to states that maintain primacy for the public water supply and UIC programs (Sec. 1443). In addition, USEPA has the authority to give similar grants to Indian tribes that obtain primacy for either program. The 1996 amendments provide for an authorization to USEPA of $100 million for each of fiscal years 1997 through 2003 for state program grants. The 1996 amendments provide that if USEPA assumes primacy of a state public water system supervision program, the agency may reserve state program grant funds that otherwise would have been provided to that state to ensure the full and effective administration of the public water system supervision program in the state. If these funds are not sufficient to ‘‘ensure full and effective administration,’’ then USEPA may reserve SRLF funds under Section 1452 to make up the shortfall. Reserved SRLF funds must be used for activities that would be required of the state if the state had primacy. The 1996 amendments added Section 1443(d) authorizing USEPA to provide financial assistance to the state of New York for demonstration projects implemented as part of the watershed program for the protection and enhancement of the quality of source waters of the New York City water supply system. Projects that demonstrate, assess, or provide for comprehensive monitoring and surveillance and projects necessary to comply with the criteria for avoiding filtration contained in 40 CFR 141.71 are eligible. The state of New York must certify to USEPA that eligible projects satisfy the purposes of this program. Priority is to be given to monitoring projects that have undergone peer review. The governor of New York must report to USEPA on the results of projects assisted no later than 5 years after the date on which USEPA first provides assistance. Federal assistance is not to exceed 50% of the total cost of the protection program being carried out for any particular watershed or groundwater recharge area. An authorization for each of fiscal years 1997 through 2003 of $15,000,000 is provided for the purpose of providing assistance to the state of New York.

SECTION 1444—SPECIAL STUDY AND DEMONSTRATION PROJECT GRANTS; GUARANTEED LOANS Section 1444(a) gives USEPA broad authority to make grants to any person for the purposes of (1) assisting in the development and demonstration (including

SECTION 1445—RECORDS AND INSPECTIONS

693

construction) of any project that will demonstrate a new or improved method, approach, or technology for providing a dependably safe supply of drinking water to the public, and (2) assisting in the development and demonstration (including construction) of any project that will investigate and demonstrate health implications involved in reclamation, recycling, and reuse of wastewaters for drinking, and the processes and methods for the preparation of safe and acceptable drinking water. Section 1444(b) provides that grants may not exceed 66.67% of the total construction cost of any facility and may not exceed 75% of any other costs. Projects must be approved by the state, and consultation with the National Drinking Water Advisory Council (NDWAC) is required. Priority is to be given to situations in which known or potential public health hazards exist that require advanced technology. Appropriations for grants were authorized for fiscal years 1974 through 1976 [Sec. 1444(c)]. A loan guarantee program was authorized for fiscal years 1974 and 1975 [Sec. 1444(d)].

SECTION 1445—RECORDS AND INSPECTIONS Every person who is a supplier of water and is or may be subject to the SDWA is required to establish and maintain records, submit reports, conduct monitoring, and provide information as the administrator may reasonably require by regulation to assist the administrator in [Sec. 1445(a)(1)]     

Establishing regulations under the SDWA. Determining compliance with regulations established under the SDWA. Administering any program of financial assistance under the SDWA. Evaluating health risks of unregulated contaminants. Advising the public of health risks.

USEPA is authorized to consider system size and the types of contaminants that might be found when establishing a monitoring schedule. This provides the agency with flexibility for small systems and those with little potential for contamination by a broad range of chemicals. Monitoring of Unregulated Contaminants The 1986 amendments established a program for monitoring unregulated contaminants. USEPA was required to set these regulations by December 1987. The monitoring schedule and frequency could be varied based on system size, types of contaminants likely to be present, and the source of the water supply. Each system will have to monitor at least every 5 years. A list of the contaminants for which systems must monitor was included in the regulations. A primacy state could add or delete contaminants with USEPA approval. This provision was satisfied when the agency promulgated the Volatile Organic Contaminants (Phase I) Rule in July

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SECTION-BY-SECTION SUMMARY OF THE SDWA

1987. Systems that were already conducting an unregulated contaminant monitoring program after Jan. 1, 1983, could have the requirements waived if their program is consistent with the regulations. Systems serving less than 150 connections could receive assistance from USEPA in taking the samples and having them analyzed. The 1996 amendments revised SDWA requirements for unregulated contaminant monitoring [Sec. 1445(a)(2)]. USEPA is required to promulgate revised regulations requiring monitoring of drinking water supplied by public water systems. The frequency and schedule for monitoring requirements for systems must be varied based on the number of persons served by the system, the source of supply, and the contaminants likely to be found. Only a representative sample of systems serving 10,000 persons or fewer are required to monitor. Key SDWA elements for unregulated contaminant monitoring under the 1996 amendments are  No later than 3 years after enactment (Aug. 6, 1999) and every 5 years thereafter, USEPA must issue a list of not more than 30 unregulated contaminants to be monitored by public water systems and to be included in the national drinking water occurrence database discussed below.  USEPA is required to include among the list of contaminants for which monitoring is required each contaminant recommended in a petition signed by the governor of each of seven or more states, unless the agency determines that the action would prevent the listing of other contaminants of a higher public health concern.  On the basis of USEPA regulations, each state may develop a representative monitoring plan to assess the occurrence of unregulated contaminants in public water systems that serve a population of 10,000 or fewer in that state. The plan must require monitoring for systems representative of different sizes, types, and geographic locations in the state. From funds appropriated or reserved from the SRLF [Sec. 1452(o)], USEPA must pay the reasonable costs of testing and laboratory analysis as are necessary to carry out monitoring under the plan.  Each public water system that conducts required monitoring of unregulated contaminants must provide the results of the monitoring to the primary enforcement authority for the system.  Notification of the availability of the results of required unregulated contaminant monitoring programs must be given to the persons served by the system.  USEPA must waive the requirement for monitoring for a contaminant in a state if the state demonstrates that the criteria for listing the contaminant do not apply in that state.  The state may use screening methods approved by USEPA in lieu of monitoring for particular unregulated contaminants.  There is authorized to be appropriated to carry out unregulated contaminant monitoring $10,000,000 for each of the fiscal years 1997 through 2003.

SECTION 1445—RECORDS AND INSPECTIONS

695

Right of Entry Section 1445(b)(1)-(2) provides the administrator or authorized representatives of the administrator with the right to enter any establishment, facility, or other property to determine whether the supplier has been or is acting in compliance with the SDWA. Appropriate credentials and a written notice must be presented. Access must be provided, at reasonable times, to all records, files, papers, processes, controls, and facilities for purposes of inspection or to test any feature of the public water system, including its source water. Primacy states must be notified by USEPA prior to entry, and USEPA must consider the impact of the entry on the state’s enforcement program prior to acting. The administrator or comptroller general (or any representative designated by either) shall have access for audit and examination to any records, reports, or information of a grantee or those receiving financial assistance. Penalties Section 1445(c) provides that failure or refusal to comply with the record and reporting requirement or the unregulated contaminant monitoring requirements of Section 1445(a) or to allow the administrator or comptroller general (or representatives of either) to enter and conduct any audit of inspection under Section 1445(b) is subject to a civil penalty not to exceed $25,000. Confidential Information USEPA is required under Section 1445(d) to consider confidential any information required to be reported to USEPA if the person submitting information shows to the satisfaction of the administrator that, if made public, the information would divulge trade secrets or secret processes. If a person fails to make a satisfactory showing, the administrator must give the person 30 days’ notice before releasing the information. Any information required under the SDWA may be disclosed to other officers, employees, or authorized representatives of the United States involved in carrying out the SDWA, or to committees of the Congress, or when relevant, in any proceeding under this title. Information, including any papers, books, or documents, or any part thereof, reported to or otherwise obtained by the administrator, can be disclosed to the extent it deals with the level of contaminants in drinking water. Grantees and Federal Agencies Section 1445(e) defines the term ‘‘grantee’’ as any person who applies for or receives financial assistance by grant, contract, or loan guarantee under the SDWA. Grantees are subject to the right of entry and other requirements of this section. The term ‘‘person’’ is defined to include a federal agency. This means that water systems owned by federal agencies are also subject to requirements of this section.

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SECTION-BY-SECTION SUMMARY OF THE SDWA

Drinking Water Coolers Section 1445(f) authorizes the administrator to apply the requirements of this section to any person who manufactures, imports, sells, or distributes drinking water coolers in interstate commerce. Occurrence Database The 1996 amendments require USEPA to assemble and maintain a national drinking water contaminant occurrence database no later than 3 years after enactment (Aug. 6, 1999). USEPA is required to use the data when making determinations under Section 1412(b)(1) regarding the occurrence of a contaminant in drinking water at a level of public health concern. The information from the data base shall be available to the public in readily accessible form. The occurrence database is to include information on the occurrence of both regulated and unregulated contaminants in public water systems and reliable information from other public and private sources. USEPA is required to solicit recommendations from the Science Advisory Board, the states, and other interested parties concerning the development and maintenance of a national drinking water contaminant occurrence database, including the structure and design of the database, data input parameters and requirements, and the use and interpretation of data. USEPA is required to periodically solicit recommendations from the appropriate officials of the National Academy of Sciences and the states, and any person may submit recommendations to the agency concerning contaminants that should be included in the occurrence database. Recommendations must be accompanied by reasonable documentation that the contaminant occurs or is likely to occur in drinking water, and the contaminant poses a risk to public health. For regulated contaminants, the occurrence database will include information on the detection of the contaminant at a quantifiable level in public water systems (including detection of the contaminant at levels not constituting a violation of the maximum contaminant level for the contaminant). For unregulated contaminants, the database will include  Monitoring information collected by public water systems that serve a population of more than 10,000, as required by USEPA.  Monitoring information collected from a representative sampling of public water systems that serve a population of 10,000 or fewer.  Other reliable and appropriate monitoring information on the occurrence of the contaminants in public water systems that is available to USEPA. Small System Technologies USEPA is authorized to request information on the characteristics of commercially available treatment systems and technologies, including the effectiveness and

SECTION 1446—NATIONAL DRINKING WATER ADVISORY COUNCIL

697

performance of the systems and technologies under various operating conditions. The agency may specify the form, content, and submission date of information to be submitted by manufacturers, states, and other interested persons for the purpose of considering the systems and technologies in the development of regulations or guidance under Section 1412(b)(4)(E) and Section 1415(e).

Screening Methods The 1996 amendments require USEPA to review new analytical methods to screen for regulated contaminants and authorizes the agency to approve methods that are more accurate or cost-effective than established reference methods for use in compliance monitoring.

SECTION 1446—NATIONAL DRINKING WATER ADVISORY COUNCIL The NDWAC was established in the 1974 SDWA to ‘‘advise, consult with, and make recommendations to the administrator on matters relating to activities, functions, and policies’’ of USEPA under the SDWA (Sec. 1446). The 15 members of the NDWAC are appointed by the USEPA administrator. Five members are appointed from the general public, five members from appropriate state and local agencies, and five members from representatives of private organizations or groups with an active interest in water hygiene and public water supply. The 1996 SDWA amendments required that two members be associated with small, rural public water systems. Members of the NDWAC receive compensation for the time they are engaged in the business of the council. The NDWAC usually meets several times each year. Meeting times and locations are announced in the Federal Register and usually include time for public statements. The USEPA Office of Ground Water and Drinking Water (OGWDW) provides administrative support for the council, but the council functions independently from USEPA.

SECTION 1447—FEDERAL AGENCIES The 1996 amendments completely revised SDWA requirements for federal agencies (Sec. 1447). Each department, agency, and instrumentality of the executive, legislative, and judicial branches of the federal government 1. Owning or operating any facility in a wellhead protection area, 2. engaged in any activity at such facility resulting, or which may result, in the contamination of water supplies in any such area, or 3. owning or operating any public water system, or

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SECTION-BY-SECTION SUMMARY OF THE SDWA

4. engaged in any activity resulting, or that may result in, underground injection that endangers drinking water, is subject to and must comply with all federal, state, interstate, and local requirements. This includes both substantive and procedural requirements, including requirements for permits or reporting or any provisions for injunctive relief and sanctions as may be imposed by a court to enforce that relief. The 1996 amendments 1. Waive sovereign immunity with respect to compliance. 2. Exempt federal agents, employees, and officers from personal civil liability for any acts or omissions within the scope of their duties, but subjects them to criminal sanctions under federal or state laws. 3. Allow exemptions from the otherwise applicable duty to comply under certain circumstances. (Exemption authority is given to the president of the United States. An exemption may apply to any federal agency. The standard for granting an exemption is revised to ‘‘the paramount interest of the United States.’’ The need for an exemption may not be based on the lack of an appropriation, unless the president has specifically requested the appropriation and Congress has not made it. The period of the exemption is limited to one year. The president may grant additional exemptions. Finally, the president is required to issue each January an annual report to Congress on any exemptions.) 4. Provide USEPA the authority to assess administrative penalties against federal agencies for violations of the SDWA and establish procedures for the assessment of penalties. (Administrative penalties of up to $25,000 may be assessed for each day that each violation occurs.) 5. Allow for public review to permit interested persons to obtain a review of an administrative penalty order in district court. (The court cannot set aside or remand the order unless there is not substantial evidence in the record to support the finding of a violation or that the assessment of the penalty by USEPA constitutes an abuse of discretion.) 6. Modify the citizen suit provisions to allow citizens to file suit against any federal agency that fails to pay a penalty assessed by USEPA by 18 months after the effective date of the final order. All funds collected by a state from the federal government from penalties and fines imposed for violations must be used by the state only for projects designed to improve or protect the environment or to defray the costs of environmental protection or enforcement. This limitation does not apply if state law in effect on the date of enactment (Aug. 6, 1996) or a state constitution requires the funds to be used in a different manner. The U.S. Army Corps of Engineers is prohibited from passing any penalty through to the users of the Washington Aqueduct system. Any penalty must be incurred exclusively by the U.S. Army Corps of Engineers.

SECTION 1448—JUDICIAL REVIEW

699

SECTION 1448—JUDICIAL REVIEW A process for judicial review of agency actions is established by Section 1448. Any individual or organization can file a petition for review of a final regulation or action under the SDWA. Petitions concerning NPDWRs must be filed in the U.S. District Court of Appeals for the District of Columbia. Petitions pertaining to any other action of the administrator under the SDWA may be filed in the circuit in which the petitioner resides or transacts business that is directly affected by the action. Petitions must be filed within 45 days of rule promulgation or issuance of the order for which review is sought. The 1996 amendments provide that petitioners must simultaneously send a copy of any petition concerning the assessment of a civil penalty under Section 1414(g)(3) by certified mail to the USEPA and the attorney general. The court will set aside and remand the penalty order if the court finds that there is not substantial evidence in the record to support the finding of a violation or that the assessment of the penalty by USEPA constitutes an abuse of discretion. SECTION 1449—CITIZEN’S CIVIL ACTION Any person can commence a civil action on his or her own behalf 1. Against any person, including the United States and governmental agencies, who is alleged to be in violation of any requirement prescribed by or under the SDWA. 2. Against USEPA where an alleged failure of the agency to perform any act or duty under the SDWA exists that is not discretionary. 3. For the collection of a penalty by the U.S. government (and associated costs and interest) against any federal agency that fails, by the date that is 18 months after the effective date of a final order to pay a penalty assessed by USEPA, to pay the penalty (Sec. 1449). The U.S. district courts have jurisdiction to enforce any requirement prescribed by or under the SDWA or to order the administrator to perform a required act or duty. The plaintiff must give at least 60 days’ notice of violation to USEPA, to the alleged violator, and to the state in which the violation occurs, prior to bringing civil action. The plaintiff must also give at least 60 days’ notice to USEPA prior to bringing civil action against the agency. If USEPA, the attorney general, or the state has commenced and is diligently prosecuting a civil action to require compliance, a citizen’s suit cannot be filed, but any person can intervene in the case. No citizen suit may be filed to require a state to prescribe a variance or exemption schedule, unless the plaintiff can show to the satisfaction of the court that the state has failed to prescribe schedules in a substantial number of cases. USEPA or the attorney general, if not a party in the case, may intervene in any citizen’s suit.

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SECTION-BY-SECTION SUMMARY OF THE SDWA

The court may award costs of litigation, including reasonable attorney and expert witness fees, to any party whenever the court decides such an award is appropriate. Civil penalties under the SDWA are only awarded in civil actions brought by USEPA or the attorney general, and not as a result of citizen suits. Any person may initiate legal action under any federal or state statute or common law to seek enforcement or relief under the SDWA. State and local governments are not restricted from taking action under state or local law. SECTION 1450—GENERAL PROVISIONS Section 1450 establishes general authorities for the administrator necessary for implementation of the requirements of the SDWA. The following general provisions are established:  Authorization for the administrator to establish regulations as necessary to carry out the SDWA [Sec. 1450(a)(1)].  Authority for the administrator to delegate any of the functions under the SDWA, other than prescribing regulations, to anyone within USEPA [Sec. 1450(a)(2)].  Authority to use employees of any other agency of the United States with the consent of the head of the agency [Sec. 1450(b)].  Authority to assign USEPA personnel to a state or interstate agency on request [Sec. 1450(c)].  Authority to make grants to individuals and nonprofit agencies or institutions [Sec. 1450(d)].  Requirement to comply with appropriate labor laws [Sec. 1450(e)].  Representation of the administrator by the attorney general in any civil action under the SDWA [Sec. 1450(f)].  Clarification that provisions of the SDWA do not affect the authority of the administrator under other portions of law [Sec. 1450(g)].  Requirement that the administrator report to Congress by April 1 of each year on the activities of USEPA under the SDWA, the actual and anticipated compliance costs to public water systems in each state, and recommendations for legislation considered necessary by the administrator [Sec. 1450(h)].  Provisions to prohibit any employer from discharging any employee or discriminating against any employee because the employee has commenced, caused to be commenced, or is about to commence or cause to be commenced a proceeding under the SDWA or a proceeding for the administration or enforcement of drinking water regulations or underground injection control programs of a state, unless that employee deliberately causes a violation of any requirement of the SDWA, acting without direction from his or her employer [Sec. 1450(i)].

SECTION 1451—INDIAN TRIBES

701

SECTION 1451—INDIAN TRIBES The 1986 amendments authorized USEPA to treat Indian tribes as states, meaning tribes can apply for and receive primary enforcement responsibility for the public water supply and UIC programs (Sec. 1451). They can also receive grant and contract funds to implement these programs. USEPA must determine that a tribe is capable of carrying out the provisions in a manner that will protect public health.

SECTION 1452—STATE REVOLVING LOAN FUNDS USEPA is required under Section 1452 to offer to enter into agreements with eligible states to make capitalization grants, including letters of credit, to the states to further the health protection objectives of the SDWA, promote the efficient use of fund resources, and for other purposes as are specified. To be eligible to receive a capitalization grant, a state must establish a drinking water treatment revolving loan fund (SRLF). Each grant to a state must be deposited in the state loan fund established by the state, except as otherwise provided. No funds authorized by other provisions of the SDWA are to be deposited in any state SRLF [Sec. 1452(a)(1)(B)]. For the purposes of the SRLF, ‘‘state’’ means each of the 50 states, the District of Columbia, and the Commonwealth of Puerto Rico. The term ‘‘Indian tribe’’ includes any Native village as defined in the Alaska Native Claims Settlement Act [Sec. 1401(13)(B)]. Section 1452(a)(1)(C) requires that the grant to a state be available to the state for obligation during the fiscal year for which the funds are authorized and during the following fiscal year, except that grants made available from funds provided prior to fiscal year 1997 will be available for obligation during each of the fiscal years 1997 and 1998.

State Allotments SRLF funds will be allotted to states [Sec. 1452(a)(1)(D)] 1. For each of fiscal years 1995 through 1997, using a formula that is the same as the formula used to distribute public water system supervision grant funds under Section 1443 in fiscal year 1995, except that the minimum proportionate share established in the formula will be 1% of available funds and the formula will be adjusted to include a minimum proportionate share for the State of Wyoming and the District of Columbia. 2. For fiscal year 1998 and each subsequent fiscal year, using a formula that allocates to each state the proportional share of the state needs identified in the most recent needs survey discussed below, except that the minimum propor-

702

SECTION-BY-SECTION SUMMARY OF THE SDWA

tionate share provided to each state will be the same as the minimum proportionate share provided under item 1. Section 1452(a)(1)(E) requires that grants not obligated by the last day of the period for which the grants are available be reallotted, except that USEPA may reserve and allocate 10% of the remaining amount for financial assistance to Indian tribes in addition to other amounts allotted. None of the funds reallotted by USEPA will be reallotted to any state that has not obligated all sums allotted to the state during the period in which the sums were available for obligation. Section 1452(a)(1)(F) requires that the state allotment for a nonprimacy state be reserved as needed by USEPA to exercise primacy in that state. The remainder of the funds must be reallotted to states exercising primary enforcement responsibility for public water systems. Whenever USEPA makes a final determination that the requirements to retain primacy are no longer being met by a state, additional grants to the state under the SDWA will be immediately terminated by USEPA. This does not apply to any state that does not have primacy as of the date of enactment (Aug. 6, 1996). Beginning in fiscal year 1999, USEPA is required under Section 1452(a)(1)(G) to withhold 20% of each capitalization grant to a state unless the state has met the requirements for capacity development [Sec. 1420(a)] and withhold 10% for fiscal year 2001, 15% for fiscal year 2002, and 20% for fiscal year 2003 if the state has not complied with capacity development strategy requirements [Sec. 1420(c)]. Not more than a total of 20% of the capitalization grants made to a state in any fiscal year may be withheld. All funds withheld by USEPA will be reallotted by the agency. None of the funds reallotted by USEPA will be allotted to a state unless the state has met capacity development requirements (Sec. 1420). USEPA is required under Section 1452(a)(1)(G)(ii) to withhold 20% of each capitalization grant unless the state has met operator certification requirements of Section 1419. All funds withheld by USEPA will be reallotted by USEPA. None of the funds reallotted by USEPA will be allotted to a state unless the state has met the operator certification requirements of Section 1419. Use of Funds Amounts deposited in a state loan fund, including loan repayments and interest earned, must be used only for providing loans or loan guarantees, as a source of reserve and security for leveraged loans, or other authorized financial assistance to community water systems and nonprofit noncommunity water systems, other than systems owned by federal agencies [Sec. 1452(a)(2)]. Financial assistance may be used by a public water system only for expenditures (not including monitoring, operation, and maintenance) of a type or category that USEPA has determined, through guidance, will facilitate compliance with NPDWRs applicable to the system under Section 1412 or otherwise significantly further the health protection objectives of the SDWA. The funds may also be used to provide loans to a system referred to in Section 1401(4)(B) for the purpose of providing the treatment

SECTION 1452—STATE REVOLVING LOAN FUNDS

703

described in Section 1401(4)(B)(i)(III). The funds cannot be used for the acquisition of real property or interests therein, unless the acquisition is integral to a project authorized by this paragraph and the purchase if from a willing seller. Of the amount credited to any state loan fund established in any fiscal year, 15% must be available solely for providing loan assistance to public water systems that regularly serve fewer than 10,000 persons to the extent such funds can be obligated for eligible projects of public water systems. No assistance can be provided to a public water system that [Sec. 1452(a)(3)(A)]  does not have the technical, managerial, and financial capability to ensure compliance with the requirements of the SDWA; or  is in significant noncompliance with any requirement of an NPDWR or variance. A public water system described above may receive SRLF assistance if [Sec. 1452(a)(3)(B)] 1. The use of the assistance will ensure compliance, 2. The owner or operator of the system agrees to undertake feasible and appropriate changes in operations (including ownership, management, accounting, rates, maintenance, consolidation, alternative water supply, or other procedures) if the state determines that the measures are necessary to ensure that the system has the technical, managerial, and financial capability to comply with the requirements of the SDWA title over the long term. Prior to providing assistance to a public water system that is in significant noncompliance with any requirement of an NPDWR or variance, the state is required to conduct a review to determine whether the system has the technical, managerial, and financial capability to ensure compliance with the requirements of the SDWA [Sec. 1452(a)(3)(C)].

Intended-Use Plans After providing for public review and comment, each state that has entered into a capitalization agreement is required to annually prepare a plan that identifies the intended uses of the amounts available to the state loan fund of the state [Sec. 1452(b)]. An intended-use plan must include [Sec. 1452(b)(2)] the following: 1. A list of the projects to be assisted in the first fiscal year that begins after the date of the plan, including a description of the project, the expected terms of financial assistance, and the size of the community served. 2. The criteria and methods established for the distribution of funds.

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SECTION-BY-SECTION SUMMARY OF THE SDWA

3. A description of the financial status of the state loan fund and the short-term and long-term goals of the state loan fund. The intended use plan must provide, to the maximum extent practicable, that priority for the use of funds be given to projects that [Sec. 1452(b)(3)]  Address the most serious risk to human health.  Are necessary to ensure compliance with the requirements of the SDWA (including requirements for filtration).  Assist systems most in need on a per household basis according to state affordability criteria. Each state is required, after notice and opportunity for public comment, to publish and periodically update a list of projects in the state that are eligible for SRLF assistance, including the priority assigned to each project and, to the extent known, the expected funding schedule for each project [Sec. 1452(b)(3)(B)]. Fund Management Section 1452(c) requires that each state loan fund be established, maintained, and credited with repayments and interest. The fund corpus shall be available in perpetuity for providing financial assistance. Fund amounts not required for current obligation or expenditure are to be invested in interest-bearing obligations. Assistance for Disadvantaged Communities In any case in which the state makes a loan to a disadvantaged community or to a community that the state expects to become a disadvantaged community as the result of a proposed project, the state may provide additional subsidization (including forgiveness of principal) [Sec. 1452(d)]. For each fiscal year, the total amount of loan subsidies made by a state may not exceed 30% of the amount of the capitalization grant received by the state for the year. The term ‘‘disadvantaged community’’ means the service area of a public water system that meets affordability criteria established after public review and comment by the state in which the public water system is located. USEPA may publish information to assist states in establishing affordability criteria. State Contribution In general, each state is required to deposit in the state loan fund from state moneys an amount equal to at least 20% of the total amount of the grant to be made to the state on or before the date on which the grant payment is made to the state. States have until Sept. 30, 1999, to deposit their contribution for fiscal years 1994, 1995, 1996, and 1997 [Sec. 1452(e)].

SECTION 1452—STATE REVOLVING LOAN FUNDS

705

Types of Assistance Except as otherwise limited by state law, the amounts deposited into a state loan fund may be used only [Sec. 1452(f)]. 1. To make loans, on the condition that (A) the interest rate for each loan is less than or equal to the market interest rate, including an interest-free loan; (B) principal and interest payments on each loan will commence no later than one year after completion of the project for which the loan was made, and each loan will be fully amortized no later than 20 years after the completion of the project, except that in the case of a disadvantaged community, a state may provide an extended term for a loan, if the extended term (i) terminates no later than the date that is 30 years after the date of project completion and (ii) does not exceed the expected design life of the project; (C) the recipient of each loan will establish a dedicated source of revenue (or, in the case of a privately owned system, demonstrate that there is adequate security) for the repayment of the loan; and (D) the state loan fund will be credited with all payments of principal and interest on each loan. 2. To buy or refinance the debt obligation of a municipality or an intermunicipal or interstate agency within the state at an interest rate that is less than or equal to the market interest rate in any case in which a debt obligation is incurred after July 1, 1993. 3. To guarantee, or purchase insurance for, a local obligation (all the proceeds of which finance a project eligible for assistance under this section) if the guarantee or purchase would improve credit market access or reduce the interest rate applicable to the obligation. 4. As a source of revenue or security for the payment of principal and interest on revenue or general obligation bonds issued by the state if the proceeds of the sale of the bonds will be deposited into the state loan fund. 5. To earn interest on the amounts deposited into the state loan fund.

Administration of Loan Funds As a convenience and to avoid unnecessary administrative costs, a state may combine, in accordance with state law, the financial administration of a drinking water state loan fund with the financial administration of any other revolving fund established by the state if otherwise not prohibited by the law under which the state loan fund was established [Sec. 1452(g)]. To combine loan funds, USEPA must determine that

706

SECTION-BY-SECTION SUMMARY OF THE SDWA

1. The grants for the drinking water SRLF, together with loan repayments and interest, will be separately accounted for and used solely for drinking water. 2. The authority to establish assistance priorities and carry out oversight and related activities (other than financial administration) with respect to assistance remains with the state agency having primary responsibility for administration of the state program under Section 1413, after consultation with other appropriate state agencies (as determined by the state) provided that in nonprimacy states eligible to receive assistance under this section, the governor determines which state agency will have authority to establish priorities for financial assistance from the state loan fund. Each state may annually use up to 4% of the funds allotted to the state to cover the reasonable costs of SRLF administration [Sec. 1452(g)(2)]. This includes the recovery of reasonable costs expended to establish a state loan fund incurred after the date of enactment (Aug. 6, 1996) and to provide technical assistance to public water systems within the state. For fiscal year 1995 and each fiscal year thereafter, each state may use up to an additional 10% of the funds allotted to the state  For public water system supervision programs [Sec. 1443(a)].  To administer or provide technical assistance through source water protection programs (but not for enforcement actions).  To develop and implement a capacity development strategy [Sec. 1420(c)] for an operator certification program for purposes of meeting the requirements of Section 1419. if the state matches the expenditures with at least an equal amount of state funds. At least half of the match must be additional to the amount expended by the state for public water supervision in fiscal year 1993. An additional 2% of the funds annually allotted to each state under this section may be used by the state to provide technical assistance to public water systems serving 10,000 or fewer persons in the state. USEPA is required to publish guidance and promulgate regulations as may be necessary to carry out the provisions of this program, including [Sec. 1452(g)(3)] 1. Provisions to ensure that each state commits and expends funds allotted to the state under this section as efficiently as possible in accordance with this title and applicable state laws. 2. Guidance to prevent waste, fraud, and abuse. 3. Guidance to avoid the use of funds made available under this section to finance the expansion of any public water system in anticipation of future population growth. The guidance and regulations must also ensure that the states and public water systems receiving assistance use accounting, audit, and fiscal procedures that conform to generally accepted accounting standards.

SECTION 1452—STATE REVOLVING LOAN FUNDS

707

Each state administering a loan fund and assistance program is required to publish and submit to USEPA a report every 2 years on its activities, including the findings of the most recent audit of the fund and the entire state allotment [Sec. 1452(g)(4)]. USEPA is required to periodically audit all state loan funds established by, and all other amounts allotted to, the states in accordance with procedures established by the comptroller general. SRLF Needs Survey USEPA is required to conduct an assessment of water system capital improvement needs of all eligible public water systems in the United States [Sec. 1452(h)]. The agency must submit a report to Congress containing the results of the assessment within 180 days after the date of enactment (Feb. 4, 1997) and every 4 years thereafter. Indian Tribes Section 1452(i) authorizes USEPA to use 1.5% of the amounts appropriated annually to make grants to Indian tribes and Alaska Native villages that have not otherwise received either grants from USEPA or assistance from state loan funds. These grants may only be used for expenditures by tribes and villages for public water system expenditures. Funds reserved must be used to address the most significant threats to public health associated with public water systems that serve Indian tribes, as determined by USEPA in consultation with the director of the Indian Health Service and Indian Tribes [Sec. 1452(i)(2)]. In the case of a grant for a project in an Alaska Native village, USEPA is authorized under Section 1452(i)(3) to make grants to the state of Alaska for the benefit of native villages. An amount not to exceed 4% of the grant amount may be used by the state of Alaska for project management. USEPA, in consultation with the director of the Indian Health Service and Indian Tribes, is required under Section 1452(i)(4) to conduct surveys and assess the needs of drinking water treatment facilities to serve Indian tribes. The assessments are to include an evaluation of the public water systems that pose the most significant threats to public health. The surveys are to be coordinated with the SRLF needs surveys. Assistance to Other Areas Of the funds annually available for SRLF grants to states, USEPA is required under Section 1452(j) to make allotments for the Virgin Islands, the Commonwealth of the Northern Mariana Islands, American Samoa, and Guam. The grants may be provided to the governments of these areas, to public water systems in these areas, or to both, to be used for the public water system expenditures. The grants, and grants for the District of Columbia, will not be deposited in state loan funds. The total allotment of

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SECTION-BY-SECTION SUMMARY OF THE SDWA

grants for all areas in any fiscal year will not exceed 0.33% of the aggregate amount made available in that fiscal year.

Other Authorized Activities States are authorized to take any of the following actions [Sec. 1452(k)]: 1. Provide assistance, only in the form of a loan, to one or more of the following: (A) Any public water system described in Section 1452(a)(2) to acquire land or a conservation easement from a willing seller or grantor, if the purpose of the acquisition is to protect the source water of the system from contamination and to ensure compliance with NPDWRs. (B) Any community water system to implement local, voluntary source water protection measures to protect source water in areas delineated under Section 1453, in order to facilitate compliance with NPDWRs applicable to the system under Section 1412, or otherwise significantly further the health protection objectives of the SDWA. Funds may be used only for voluntary, incentive-based mechanisms. (C) Any community water system to provide funding in accordance with Section 1454(a)(1)(B)(i). 2. Provide assistance, including technical and financial assistance, to any public water system as part of a capacity development strategy developed and implemented in accordance with Section 1420(c). 3. Make expenditures from the capitalization grant of the state for fiscal years 1996 and 1997 to delineate and assess source water protection areas in accordance with Section 1453, except that funds set aside for such expenditure shall be obligated within four fiscal years. 4. Make expenditures from the fund for the establishment and implementation of wellhead protection programs under Section 1428. For each fiscal year, the total amount of assistance provided and expenditures made by a state under this provision may not exceed 15% of the amount of the capitalization grant received by the state for that year and may not exceed 10% of that amount for anyone of the following activities [Sec. 1452(k)(2)]: 1. To acquire land or conservation easements under Section 1452(k)(l)(A)(i). 2. To provide funding to implement voluntary, incentive-based source water quality protection measures. 3. To provide assistance through a capacity development strategy. 4. To make expenditures to delineate or assess source water protection areas. 5. To make expenditures to establish and implement wellhead protection programs.

SECTION 1452—STATE REVOLVING LOAN FUNDS

709

Section 1452(k)(3) notes that nothing in this provision creates or conveys any new authority to a state, political subdivision of a state, or community water system for any new regulatory measures, or limits any authority of a state, political subdivision of a state or community water system. Delays Section 1452(1) provides that failure or inability of any public water system to receive SRLF funds or any other loan or grant program, or any delay in obtaining the funds, will not alter the obligation of the system to comply in a timely manner with all applicable drinking water standards and requirements of the SDWA. Authorization Section 1452(m) authorizes appropriations of $599,000,000 for the fiscal year 1994 and $1,000,000,000 for each of the fiscal years 1995 through 2003. To the extent amounts authorized to be appropriated in any fiscal year are not appropriated in that fiscal year, the amounts are authorized to be appropriated in a subsequent fiscal year (prior to the fiscal year 2004). Appropriated funds remain available until expended. Health Effects Studies Section 1452(n) requires USEPA to reserve $10,000,000 from funds appropriated for SRLF grants for each fiscal year for health effects studies on drinking water contaminants. In allocating funds made available under this provision, USEPA must give priority to studies concerning the health effects of Cryptosporidium [Sec. 1458(c)], disinfection byproducts [Sec. 1458(c)], and arsenic [Sec. 1412(b)(12)(A)], and the implementation of a plan for studies of subpopulations at greater risk of adverse effects [Sec. 1458(a)]. Unregulated Contaminant Monitoring Section 1452(o) requires USEPA to reserve funds appropriated for SRLF grants to pay the costs of monitoring for unregulated contaminants. Two million dollars are to be reserved for each fiscal year beginning with 1998. State of Virginia Demonstration Project Section 1452(p) allows the state of Virginia, with approval of the Virginia General Assembly and USEPA, to conduct a program to demonstrate alternative approaches to intergovernmental coordination to assist in the financing of new drinking water facilities in the following rural communities in southwestern Virginia where none existed on the date of enactment (Aug. 6, 1996) and where such communities are experiencing economic hardship: Lee County, Wise County, Scott County, Dickenson County, Russell County, Buchanan County, Tazewell County, and the city of

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SECTION-BY-SECTION SUMMARY OF THE SDWA

Norton, VA. The funds allotted to that state and deposited in the state loan fund may be loaned to a regional endowment fund for this purpose under a plan to be approved by USEPA. The plan may involve an advisory group that includes representatives from these counties. Small System Technical Assistance Section 1452(q) allows USEPA to reserve up to 2% of the total funds appropriated for each of the fiscal years 1997 through 2003 to provide technical assistance for small systems under Section 1442(e). The total amount of funds made available for this purpose in any fiscal year through appropriations under Section 1442(e) and reservations of SRLF funds must not exceed the amount authorized by Section 1442(e) ($15 million). Evaluation Section 1452(r) requires USEPA to conduct an evaluation of the effectiveness of the state loan funds through fiscal year 2001. The evaluation must be submitted to the Congress at the same time as the president submits to the Congress, pursuant to Section 1108 of Title 31, United States Code, an appropriations request for fiscal year 2003 relating to the budget of the USEPA.

SECTION 1453—SOURCE WATER QUALITY ASSESSMENT The 1996 amendments established a new state program under Section 1453 to assess source water quality. A state source water assessment program is to 1. Delineate the boundaries of the assessment areas in the state from which one or more public water systems in the state receive supplies of drinking water. The assessment program will use all reasonably available hydro geologic information on the sources of the supply of drinking water in the state and the water flow, recharge, discharge, and any other reliable information as the state deems necessary to adequately determine such areas. 2. Identify contaminants regulated under the SDWA for which monitoring is required (or any unregulated contaminants selected by the state, in its discretion, which the state, for the purposes of this subsection, has determined may present a threat to public health), to determine the susceptibility of the public water systems in the delineated area to the contaminants. USEPA is required to publish guidance for states to follow in establishing source water quality assessment programs within 12 months after enactment (by Aug. 6, 1997). Each state adopting modifications to monitoring requirements under Section 1418(b) will be required to have an approved source water assessment program.

SECTION 1454—SOURCE WATER PETITION PROGRAM

711

A state source water assessment program is to be submitted to USEPA within 18 months after USEPA’s guidance is issued. The program will be considered approved 9 months after the date of submittal unless USEPA disapproves the program. States are to begin implementation of the program immediately after its approval. USEPA’s approval of a state program will include a timetable, established in consultation with the state, allowing not more than 2 years for completion after approval of the program. Public water systems seeking monitoring relief in addition to the interim relief provided under Section 1418(a) will be eligible for monitoring relief, consistent with Section 1418(b), on completion of the assessment in the delineated source water assessment area or areas concerned. Implementation timetables are to take into consideration the availability to the state of SRLF funds under Section 1452 for assessments and other relevant factors. USEPA may modify any timetable included in an approved state program to extend the period for completion by an additional 18 months. USEPA is required, as soon as practicable, to conduct a demonstration project, in consultation with other federal agencies, to demonstrate the most effective and protective means of assessing and protecting source waters on federal lands that serve large metropolitan areas. To avoid duplication and encourage efficiency, source water quality assessment programs may make use of other appropriate programs. Results of the source water assessments must be made available to the public. SECTION 1454—SOURCE WATER PETITION PROGRAM The 1996 amendments added Section 1454 authorizing states to establish a source water petition program. States may establish a program under which an owner or operator of a community water system in the state, or a municipal or local government or political subdivision of a state, may submit a source water quality protection partnership petition to the state requesting that the state assist in the local development of a voluntary, incentive-based partnership among the owner, operator, or government and other persons likely to be affected by the recommendations of the partnership. The purpose of the program is to 1. Reduce the presence in drinking water of contaminants that may be addressed by a petition by considering the origins of the contaminants, including to the maximum extent practicable, the specific activities that affect the drinking water supply of a community. 2. Obtain financial or technical assistance necessary to help establish a partnership or to develop and implement recommendations of a partnership for the protection of source water to assist in the provision of drinking water that complies with NPDWRs with respect to contaminants addressed by a petition. 3. Develop recommendations regarding voluntary and incentive-based strategies for the long-term protection of the source water of community water systems.

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SECTION-BY-SECTION SUMMARY OF THE SDWA

States may use SRLF funds set aside under Section 1452(k)(1)(A)(iii) by the state to carry out a source water petition program, including assistance to voluntary local partnerships for the development and implementation of partnership recommendations for the protection of source water. Such programs would include source water quality assessment, contingency plans, and demonstration projects for partners within a source water area delineated under Section 1453(a).

Petition Objectives The objectives of a source water petition must be to 1. Facilitate the local development of voluntary, incentive-based partnerships among owners and operators of community water systems, governments, and other persons in source water areas 2. Obtain assistance from the state in identifying resources that are available to implement the recommendations of the partnerships to address the origins of drinking water contaminants that may be addressed by a petition (including, to the maximum extent practicable, the specific activities contributing to the presence of the contaminants) that affect the drinking water supply of a community

Contaminants Addressed by a Petition A source water petition may address only those contaminants  that are pathogenic organisms for which an NPDWR has been established or is required under Section 1412; or  for which an NPDWR has been promulgated or proposed and that are detected by adequate monitoring methods in the source water at the intake structure or in any collection, treatment, storage, or distribution facilities by the community water systems at levels above the MCL or that are not reliably and consistently below the MCL.

Contents of a Petition A source water petition, at a minimum, must 1. Include a delineation of the source water area in the state that is the subject of the petition. 2. Identify, to the maximum extent practicable, the origins of the drinking water contaminants that may be addressed by a petition (including, to the maximum extent practicable, the specific activities contributing to the presence of the contaminants) in the source water area delineated under Section 1453.

SECTION 1454—SOURCE WATER PETITION PROGRAM

713

3. Identify any deficiencies in information that will impair the development of recommendations by the voluntary local partnership to address drinking water contaminants that may be addressed by a petition. 4. Specify the efforts made to establish the voluntary local partnership and obtain the participation of (A) the municipal or local government or other political subdivision of the state with jurisdiction over the source water area delineated under Section 1453, and (B) each person in the source water area delineated under Section 1453 (i) who is likely to be affected by recommendations of the voluntary local partnership; and (ii) whose participation is essential to the success of the partnership. 5. Outline how the voluntary local partnership has or will, during development and implementation of recommendations of the voluntary local partnership, identify, recognize, and take into account any voluntary or other activities already being undertaken by persons in the source water area delineated under Section 1453 under federal or state law to reduce the likelihood that contaminants will occur in drinking water at levels of public health concern. 6. Specify the technical, financial, or other assistance that the voluntary local partnership requests of the state to develop the partnership or to implement recommendations of the partnership.

Petition Approval Section 1454(b) sets forth requirements for approval and disapproval of petitions. After providing notice and an opportunity for public comment on a submitted petition, the state is required to approve or disapprove the petition, in whole or in part, no later than 120 days after the date of submission. The state may approve a petition if the petition meets the requirements established under Section 1454(a). The notice of approval, at a minimum, must include for informational purposes 1. An identification of technical, financial, or other assistance that the state will provide to assist in addressing the drinking water contaminants that may be addressed by a petition based on (A) the relative priority of the public health concern identified in the petition with respect to the other water quality needs identified by the state, (B) any necessary coordination that the state will perform of the program established under this section with programs implemented or planned by other states under this section, and (C) funds available (including funds available from an SRLF established under Title VI of the Federal Water Pollution Control Act (33 USC 1381 et seq.) or Section 1452.

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SECTION-BY-SECTION SUMMARY OF THE SDWA

2. A description of technical or financial assistance pursuant to federal and state programs that is available to assist in implementing recommendations of the partnership in the petition, including (A) any program established under the Federal Water Pollution Control Act (33 USC 1251 et seq.), (B) the program established under Section 6217 of the Coastal Zone Act Reauthorization Amendments of 1990 (16 USC 1455b), (C) the agricultural water quality protection program established under Chapter 2 of Subtitle D of Title XII of the Food Security Act of 1985 (16 USC 3838 et seq.), (D) the sole-source aquifer protection program established under Section 1427, (E) the community wellhead protection program established under Section 1428, (F) any pesticide or groundwater management plan, (G) any voluntary agricultural resource management plan or voluntary whole farm or whole ranch management plan developed and implemented under a process established by the Secretary of Agriculture, (H) any abandoned well closure program. 3. A description of activities that will be undertaken to coordinate federal and state programs to respond to the petition. If the state disapproves a petition, the state must in writing notify the entity submitting the petition of the reasons for disapproval. A petition may be resubmitted at any time if new information becomes available, conditions affecting the source water that is the subject of the petition change, or modifications are made in the type of assistance being requested. Grants for State Programs Section 1454(c) authorizes USEPA to make a grant to each state that establishes an approved source water petition program. The amount of each grant may not exceed 50% of the cost of administering the program for the year in which the grant is available. To receive grant assistance, a state is required to submit to USEPA for approval a plan for a source water quality protection partnership program that is consistent with USEPA guidance. USEPA is required to approve the plan if the plan is consistent with the agency’s guidance. USEPA Guidance USEPA is required under Section 1454(d) to publish guidance no later than Aug. 6, 1997, in consultation with the states, to assist

SECTION 1455—WATER CONSERVATION PLAN

715

1. States in the development of a source water quality protection partnership program. 2. Municipal or local governments or political subdivisions of a state and community water systems in the development of source water quality protection partnerships and in the assessment of source water quality. The guidance will, at a minimum 1. 2. 3. 4.

Recommend procedures for the approval or disapproval by a state of a petition. Recommend procedures for the submission of petitions. Recommend criteria for the assessment of source water areas within a state. Describe technical or financial assistance pursuant to federal and state programs that is available to address the contamination of sources of drinking water and to develop and respond to petitions submitted.

Funding Authorization Appropriations of $5,000,000 for each of the fiscal years 1997 through 2003 are to be authorized to implement the requirements of Section 1454. Each state with a plan for an approved source water petition program will receive an equitable portion of the funds available for any fiscal year. Statutory Construction Nothing in Section 1454  creates or conveys new authority to a state, political subdivision of a state, or community water system for any new regulatory measure, or  limits any authority of a state, political subdivision, or community water system, or  precludes a community water system, municipal or local government, or political subdivision of a government from locally developing and carrying out a voluntary, incentive-based, source water quality protection partnership to address the origins of drinking water contaminants of public health concern.

SECTION 1455—WATER CONSERVATION PLAN The 1996 amendments require USEPA to publish guidelines for water conservation no later than 2 years after the date of enactment (Aug. 6, 1998). USEPA is required to publish the guidelines in the Federal Register for public water systems serving fewer than 3300 persons, public water systems serving between 3300 and 10,000 persons, and public water systems serving more than 10,000 persons, taking into consideration factors such as water availability and climate.

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SECTION-BY-SECTION SUMMARY OF THE SDWA

Within one year after publication of USEPA’s guidelines, a primacy state may require a public water system, as a condition of receiving a loan or grant from a state loan fund under Section 1452, to submit with its application for an SRLF loan or grant a water conservation plan consistent with USEPA’s guidelines.

SECTION 1456—ASSISTANCE TO COLONIAS The 1996 amendments added Section 1456 to provide assistance to colonias. USEPA and the heads of other appropriate federal agencies are authorized to award grants to a border state (Arizona, California, New Mexico, and Texas) to provide assistance to eligible communities to facilitate compliance with NPDWRs or otherwise significantly further the health protection objective of the SDWA. An ‘‘eligible community’’ is a low-income community with economic hardship that 1. Is commonly referred to as a ‘‘colonia.’’ 2. Is located along the United States–Mexico border (generally in an unincorporated area). 3. Lacks a safe drinking water supply or adequate facilities for the provision of safe drinking water for human consumption. Grants are to be used to provide assistance to one or more eligible communities where residents are subject to a significant health risk (as determined by USEPA or the head of the federal agency making the grant) attributable to the lack of access to an adequate and affordable drinking water supply system. The amount of a grant awarded cannot exceed 50% of the costs of carrying out the project that is the subject of the grant. Appropriations of $25,000,000 are to be authorized for each of the fiscal years 1997 through 1999 for assistance to colonias.

SECTION 1457—ESTROGENIC SUBSTANCES SCREENING PROGRAM USEPA is authorized under Section 1457 to include in the estrogenic substances screening program established under the Food Quality Protection Act (H.R. 1627) any substance that may be found in drinking water if the agency determines that a substantial population may be exposed to the substance.

SECTION 1458—DRINKING WATER STUDIES The 1996 amendments require USEPA to conduct certain studies regarding subpopulations at greater risk, biological mechanisms, harmful substances, and waterborne disease.

SECTION 1458—DRINKING WATER STUDIES

717

Subpopulations at Greater Risk USEPA is required under Section 1458(a) to conduct a continuing program of studies to identify groups within the general population that may be at greater risk than the general population to adverse health effects from exposure to contaminants in drinking water. The study is to examine whether and to what degree infants, children, pregnant women, the elderly, individuals with a history of serious illness, or other subpopulations that can be identified and characterized are likely to experience elevated health risks, including risks of cancer, from contaminants in drinking water. USEPA is required to report to Congress on the results of the studies no later than Aug. 6, 2000, and periodically thereafter as new and significant information becomes available.

Biological Mechanisms USEPA is required under Section 1458(b) to conduct biomedical studies to 1. Understand the mechanisms by which chemical contaminants are absorbed, distributed, metabolized, and eliminated from the human body, so as to develop more accurate physiologically based models of the phenomena. 2. Understand the effects of contaminants and the mechanisms by which the contaminants cause adverse effects (especially noncancer and infectious effects) and the variations in the effects among humans, especially subpopulations at greater risk of adverse effects, and between test animals and humans. 3. Develop new approaches to the study of complex mixtures, such as mixtures found in drinking water, especially to determine the prospects for synergistic or antagonistic interactions that may affect the shape of the dose–response relationship of the individual chemicals and microbes, and to examine noncancer endpoints and infectious diseases, and susceptible individuals and subpopulations.

Studies on Harmful Substances in Drinking Water USEPA is required under Section 1458(c) to, no later than 180 days after enactment (Feb. 3, 1997) and after consultation with the secretary of Health and Human Services, the Secretary of Agriculture, and, as appropriate, the heads of other federal agencies, conduct studies to support the development and implementation of the most current version of each of the following: 1. Enhanced Surface Water Treatment Rule [Fed. Reg. 59:38832 (July 29, 1994)]. 2. Disinfectant and Disinfection By-products Rule [Fed. Reg. 59:38668 (July 29, 1994)].

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SECTION-BY-SECTION SUMMARY OF THE SDWA

3. Ground Water Disinfection Rule (availability of draft summary announced at [Fed. Reg. 57:33960 (July 31, 1992)]. The studies are required to include, at a minimum, each of the following: 1. Toxicologic studies and, if warranted, epidemiologic studies to determine what levels of exposure from disinfectants and disinfection byproducts, if any, may be associated with developmental and birth defects and other potential toxic endpoints. 2. Toxicologic studies and, if warranted, epidemiologic studies to quantify the carcinogenic potential from exposure to disinfection byproducts resulting from different disinfectants. 3. The development of dose–response curves for pathogens, including Cryptosporidium and the Norwalk virus. Appropriations of $12,500,000 are to be authorized for each of fiscal years 1997 through 2003 to carry out these studies.

Waterborne Disease Occurrence Study USEPA and the Centers for Disease Control and Prevention (CDC) are jointly required under Section 1458(d) to 1. Within 2 years after enactment (Aug. 6, 1998), conduct pilot waterborne disease occurrence studies for at least five major U.S. communities or public water systems. 2. Within 5 years after enactment (Aug. 6, 2001), prepare a report on the findings of the pilot studies, and a national estimate of waterborne disease occurrence. CDC and USEPA are required to jointly establish a national healthcare provider training and public education campaign to inform both the professional healthcare provider community and the general public about waterborne disease and the symptoms that may be caused by infectious agents, including microbial contaminants. In developing the campaign, comments must be sought from interested groups and individuals, including scientists, physicians, state and local governments, environmental groups, public water systems, and vulnerable populations. Appropriations of $3,000,000 are to be authorized for each of the fiscal years 1997 through 2001 to carry out these programs. To the extent that these funds are not fully appropriated, USEPA may use not more than $2,000,000 of SRLF funds from amounts reserved under Section 1452(n) for health effects studies for this purpose. USEPA may transfer a portion of the funds to the CDC for this purpose.

SECTION 1461—DEFINITIONS

719

SECTION 1461—DEFINITIONS Definitions presented in Section 1461 apply to Subpart F, Additional Requirements to Regulate the Safety of Drinking Water. The definitions include the following key terms:  Drinking Water Cooler: Any mechanical device affixed to drinking water supply plumbing that actively cools water for human consumption.  Lead Free: With respect to a drinking water cooler, that each part or component of the cooler that may come in contact with drinking water contains no more than 8% lead, except that no drinking water cooler that contains any solder, flux, or storage tank interior surface that may come in contact with drinking water shall be considered lead-free if the solder, flux, or storage tank interior surface contains more than 0.2% lead. The administrator may establish more stringent requirements for components to be ‘‘lead-free’’ if the component is an important source of lead in drinking water.

SECTION 1462—RECALL OF DRINKING WATER COOLERS WITH LEAD-LINED TANKS The Consumer Products Safety Commission (CPSC) is required under Section 1462 to issue an order by November 1989 requiring manufacturers and importers of drinking water coolers with lead-lined tanks to repair, replace, or recall and provide a refund for the coolers. Drinking water coolers with lead-lined tanks are designated ‘‘imminently hazardous consumer products.’’

SECTION 1463—DRINKING WATER COOLERS CONTAINING LEAD USEPA was required under Section 1463 to publish and update periodically a list of drinking water coolers that are not lead-free, including those with lead-lined tanks. Drinking water coolers that are not lead-free, including those with lead-lined tanks, may not be sold in interstate commerce or manufactured for sale in interstate commerce. Violations of this prohibition are subject to criminal penalties (including imprisonment for up to 5 years) and civil penalties of up to $5000 ($50,000 in the case of a second or subsequent violation).

SECTION 1464—LEAD CONTAMINATION IN SCHOOL DRINKING WATER USEPA is required under Section 1464 to distribute the list of drinking water coolers that are not lead-free to the states and also to prepare a guidance document and

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SECTION-BY-SECTION SUMMARY OF THE SDWA

testing protocol to assist schools in determining the source and degree of lead contamination in school drinking water. States are required under Section 1464(c) and (d) to establish a program to control lead contamination in school drinking water. The state program is targeted at local educational agencies, private nonprofit elementary or secondary schools, and daycare centers and must include  dissemination of the guidance document and testing protocol and the list of drinking water coolers that are not lead-free,  assistance in testing for and remedying lead contamination in drinking water, and  repair, replacement, permanent removal, or rendering inoperable drinking water coolers that are not lead-free that contribute lead to drinking water. Test results must be made available in the administrative offices of the local educational agency for inspection by the public, teachers and other school personnel, and parents. Parents, teachers, and employees must be notified by the organization of the availability of the test results. On April 22, 1996, Section 1464(d) was declared unconstitutional by the U.S. Court of Appeals for the Fifth Circuit. The Association of Community Organizations for Reform Now (ACORN) and two parents sued the state of Louisiana for failing to perform its duty under Section 1464(d). The case was dismissed after Louisiana began complying with the act. The Fifth Circuit overturned the section on appeal of the award of attorney’s fees to the plaintiffs. The court determined that the provision violates the 10th Amendment of the U.S. Constitution because it coerces states into enforcing a federal regulatory program.

SECTION 1465—FEDERAL ASSISTANCE FOR STATE PROGRAMS REGARDING LEAD CONTAMINATION IN SCHOOL DRINKING WATER Section 1465 authorizes USEPA to make grants to states to carry out state programs that assist local educational agencies in testing for, and remedying, lead contamination in drinking water. Grants may be used by states to reimburse local educational agencies for expenses incurred for testing water coolers, testing for lead contamination, and remedial action. No more than $30,000,000 was authorized for each fiscal year 1989, 1990, and 1991.

Appendix D TEXT OF THE SDWA AS AMENDED COMPILED BY FREDERICK W. PONTIUS, P.E. Pontius Water Consultants, Inc., Lakewood, Colorado

This Appendix presents the entire text of the Safe Drinking Water Act (SDWA), as amended by the SDWA Amendments of 1977, 1979, 1980, 1986, the Lead Contamination Control Act of 1988, the SDWA Amendments of 1996, and the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. OUTLINE Title XIV—Safety of Public Water Systems Section 1400—Short Title

Part A—Definitions Section 1401—Definitions

Part B—Public Water Systems Section 1411—Coverage Section 1412—National Drinking Water Regulations (a) Untitled (b) Standards Drinking Water Regulation and Health, Edited by Frederick W. Pontius. ISBN 0-471-41554-5 # 2003 John Wiley & Sons, Inc.

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TEXT OF THE SDWA AS AMENDED

(1) Identification of contaminants for listing (A) General authority (B) Regulation of unregulated contaminants (i) Listing of contaminants for consideration (ii) Determination to regulate (iii) Review (C) Priorities (D) Urgent threats to public health (E) Regulation (F) Health advisories and other actions (2) Schedules and deadlines (A) In general (B) Substitution of contaminants (C) Disinfectants and disinfection byproducts (3) Risk assessment, management, and communication (A) Use of science in decisionmaking (B) Public information (C) Health risk reduction and cost analysis (i) Maximum contaminant levels (ii) Treatment technologies (iii) Approaches to measure and value benefits (iv) Authorization (4) Goals and standards (A) Maximum contaminant level goals (B) Maximum contaminant levels (C) Determination (D) Definition of feasible (E) Feasible technologies (i) In general (ii) List of technologies for small systems (iii) List of technologies that achieve compliance (iv) Additional technologies (v) Technologies that meet the Surface Water Treatment Rule (5) Additional health risk considerations (A) In general (B) Establishment of level (6) Additional health risk reduction and cost considerations (A) In general

OUTLINE

(7) (8) (9) (10) (11) (12)

(13)

(14) (15)

(B) Exception (C) Disinfectants and disinfection byproducts (D) Judicial review Untitled Disinfection Review and revision Effective date Untitled Certain contaminants (A) Arsenic (i) Schedule and standard (ii) Study plan (iii) Cooperative agreements (iv) Proposed regulations (v) Final regulations (vi) Authorization (B) Sulfate (i) Additional study (ii) Determination (iii) Proposed and final rule Radon in drinking water (A) National Primary Drinking Water Regulation (B) Risk assessment and studies (C) Health risk reduction and cost analysis (D) Proposed regulation (E) Final regulation (F) Alternative maximum contaminant level (G) Multimedia radon mitigation programs (i) In general (ii) Elements of programs (iii) Approval (iv) Review (v) Extension (vi) Local programs Recycling of filter backwash Variance technologies (A) In general (B) Limitation

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TEXT OF THE SDWA AS AMENDED

(C) Additional information (D) Regulations and guidance (c) Untitled (d) Untitled (e) Untitled Section 1413—State Primacy Enforcement Responsibility (a) Untitled (b) Untitled (c) Interim primary enforcement authority Section 1414—Enforcement of Drinking Water Regulations (a) Untitled (1) Untitled (2) Enforcement in nonprimacy States (A) In general (B) Notice (b) Untitled (c) Notice to persons served (1) In general (2) Form, manner, and frequency of notice (A) In general (B) State requirements (i) In general (ii) Contents (iii) Relationship to Section 1413 (C) Violations with potential to have serious adverse effects on human health (D) Written notice (i) In general (ii) Form and manner of notice (E) Unregulated contaminants (3) Reports (A) Annual report by State (i) In general (ii) Distribution (B) Annual report by administrator (4) Consumer confidence reports by community water systems (A) Annual report to consumers

OUTLINE

(d) (e) (f ) (g) (h)

(i)

(B) Contents of report (C) Coverage (D) Alternative to publication (E) Alternative form and content Untitled Untitled Untitled Untitled Consolidation incentive (1) In general (2) Consequences of approval Definition of applicable requirement

Section 1415—Variances (a) Untitled (b) Untitled (c) Untitled (d) Untitled (e) Small system variances (1) In general (2) Availability of variances (3) Conditions for granting variances (4) Compliance schedules (5) Duration of variances (6) Ineligibility for variances (7) Regulations and guidance (A) In general (B) Affordability criteria (8) Review by the administrator (A) In general (B) Notice and publication (9) Approval of variances (10) Objections to variances (A) By the administrator (B) Petition by consumers (C) Timing

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Section 1416—Exemptions (a) Untitled (b) Untitled (c) Untitled (d) Untitled (e) Untitled (f ) Untitled (g) Untitled Section 1417—Prohibition on Use of Lead Pipes, Solder, and Flux (a) In general (1) Prohibitions (A) In general (B) Leaded joints (2) Public notice requirements (A) In general (B) Contents of notice (b) State enforcement (1) Enforcement of prohibition (2) Enforcement of public notice requirements (c) Penalties (d) Definitions of ‘‘lead-free’’ (e) Plumbing fittings and fixtures (1) In general (2) Standards (A) In general (B) Alternative requirement Section 1418—Monitoring of Contaminants (a) In general (1) In general (2) Termination; timing of monitoring (b) Permanent monitoring relief authority (1) In general (2) Guidelines (A) In general (B) Definition (3) Effect of detection on contaminants (4) States not exercising primary enforcement responsibility

OUTLINE

(c) Treatment as NPDWR (d) Other monitoring relief Section 1419—Operator Certification (a) Guidelines (b) State programs (c) Existing programs (d) Expense reimbursement (1) In general (2) State grants (3) Authorization (4) Reservation Section 1420—Capacity Development (a) State authority for new systems (b) Systems in significant noncompliance (1) List (2) Report (3) Withholding (c) Capacity development strategy (1) In general (2) Content (3) Report (4) Review (d) Federal assistance (1) In general (2) Informational assistance (A) In general (B) Publication of information (3) Promulgation of drinking water regulations (4) Guidelines for new systems (e) Variances and exemptions (f ) Small public water systems technology assistance centers (1) Grant program (2) Responsibilities of the centers (3) Applications (4) Selection criteria (5) Consortia of States (6) Authorization of appropriations

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TEXT OF THE SDWA AS AMENDED

(g) Environmental finance centers (1) In general (2) National capacity development clearinghouse (3) Capacity development techniques (4) Authorization of appropriations (5) Limitation

Part C—Protection of Underground Sources of Drinking Water Section 1421—Regulations for State Programs (a) Untitled (b) Untitled (c) Untitled (d) Untitled Section 1422—State Primacy Enforcement Responsibility (a) Untitled (b) Untitled (c) Untitled (d) Untitled (e) Untitled Section 1423—Enforcement of Program (a) Untitled (b) Civil and criminal actions (c) Administrative orders (d) Untitled Section 1424—Interim Regulation of Underground Injection (a) Untitled (b) Untitled (c) Untitled (d) Untitled (e) Untitled Section 1425—Optional Demonstration by States Relating to Oil or Natural Gas (a) Untitled (b) Untitled (c) Untitled

OUTLINE

Section 1426—Regulation of State Programs (a) Monitoring methods (b) Report Section 1427—Sole Source Aquifer Demonstration Program (a) Purpose (b) Definition (c) Application (d) Criteria (e) Contents of application (f ) Comprehensive plan (g) Plans under Section 208 of the Clean Water Act (h) Consultation and hearings (i) Approval or disapproval ( j) Grants and reimbursement (k) Activities funded under other law (l) Report (m) Savings provision (n) Authorization Section 1428—State Programs to Establish Wellhead Protection Areas (a) State programs (b) Public participation (c) Disapproval (1) In general (2) Modification and resubmission (d) Federal assistance (e) Definition of wellhead protection area (f ) Prohibitions (1) Activities under other laws (2) Individual sources (g) Implementation (h) Federal agencies (i) Additional requirements (1) In general (2) Definition (3) Review (4) Disapproval

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TEXT OF THE SDWA AS AMENDED

(j) Coordination with other laws (k) Authorization of appropriations Section 1429—State Groundwater Protection Grants (a) In general (b) Guidance (c) Coordination of grants (1) In general (2) Innovative program grants (3) Allocation of funds (4) Limitations (d) Amount of grants (e) Evaluations and reports (f ) Authorization of appropriations

Part D—Emergency Powers Section 1431—Emergency Powers (a) Untitled (b) Untitled Section 1432—Tampering with Public Water Systems (a) Tampering (b) Attempt or threat (c) Civil penalty (d) Definition of tamper Section 1433—Terrorist and Other Intentional Act (a) Vulnerability Assessments (b) Emergency Response Plan (c) Record Maintenance (d) Guidance of Small Public Water Systems (e) Funding Section 1434—Contaminant Prevention, Detection, and Response (a) In General (b) Funding

OUTLINE

731

Section 1435—Supply Disruption Prevention, Detection, and Response (a) Disruption of supply or safety (b) Alternative sources (c) Requirements and considerations (d) Information sharing (e) Funding

Part E—General Provisions Section 1441—Assurance of Availability of Adequate Supplies of Chemicals Necessary for Treatment of Water (a) Untitled (b) Untitled (c) Untitled (d) Untitled (e) Untitled (f ) Untitled Section 1442—Research, Technical Assistance, Information, and Training of Personnel (a) Untitled (1) Untitled (2) Information and research facilities (3) Untitled (4) Untitled (5)–(10) Untitled (b) Untitled (c) Untitled (d) Untitled (e) Technical assistance (f ) Untitled (g) Untitled Section 1443—Grants for State Programs (a) Untitled (1)–(5) Untitled (6) Untitled (7) Authorization (8) Reservation of funds by the administrator

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TEXT OF THE SDWA AS AMENDED

(9) State loan funds (A) Reservation of funds (B) Duty of administrator (b) Untitled (c) Untitled (d) New York City watershed protection program (1) In general (2) Report (3) Matching requirements (4) Authorization Section 1444—Special Study and Demonstration Project Grants; Guaranteed Loans (a) Untitled (b) Untitled (c) Untitled (d) Untitled Section 1445—Records and Inspections (a) Untitled (1) Untitled (2) Monitoring program for unregulated contaminants (A) Establishment (B) Monitoring programs for certain unregulated contaminants (i) Initial list (ii) Governor’s petition (C) Monitoring plan for small and medium systems (i) In general (ii) Grants for small system costs (D) Monitoring results (E) Notification (F) Waiver of monitoring requirement (G) Analytical methods (H) Authorization (b) Untitled (c) Untitled (d) Untitled (e) Untitled (f ) Information regarding drinking water coolers (g) Occurrence database

OUTLINE

(1) In general (2) Public input (3) Use (4) Public recommendations (5) Public availability (6) Regulated contaminants (7) Unregulated contaminants (h) Availability of information on small system technologies (i) Screening methods Section 1446—National Drinking Water Advisory Council (a) Untitled (b)–(d) Untitled Section 1447—Federal Agencies (a) In general (b) Administrative penalty orders (1) In general (2) Penalties (3) Procedure (4) Public review (A) In general (B) Record (C) Standard of review (D) Prohibition on additional penalties (c) Limitation on State use of funds collected from Federal government (d) Untitled (e) Washington aqueduct Section 1448—Judicial Review (a) Untitled (b) Untitled (c) Untitled Section 1449—Citizen’s Civil Action (a) Untitled (b) Untitled (c)–(e) Untitled

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TEXT OF THE SDWA AS AMENDED

Section 1450—General Provisions (a)–(i) Untitled Section 1451—Indian Tribes (a) In general (b) EPA regulations (1) Specific provisions (2) Provisions where treatment as State inappropriate Section 1452—State Revolving Loan Fund (a) General authority (1) Grants to States to establish State loan funds (A) In general (B) Establishment of fund (C) Extended period (D) Allotment formula (E) Reallotment (F) Nonprimacy States (G) Other programs (i) New system capacity (ii) Operator certification (2) Use of funds (3) Limitation (A) In general (B) Restructuring (C) Review (b) Intended-use plans (1) In general (2) Contents (3) Use of funds (A) In general (B) List of projects (c) Fund management (d) Assistance for disadvantaged communities (1) Loan subsidy (2) Total amount of subsidies (3) Definition of disadvantaged community (e) State contribution (f ) Types of assistance

OUTLINE

(g) Administration of State loan funds (1) Combined financial administration (2) Cost of administering fund (3) Guidance and regulations (4) State report (h) Needs survey (i) Indian Tribes (1) In general (2) Use of funds (3) Alaska native villages (4) Needs assessment ( j) Other areas (k) Other authorized activities (1) In general (2) Limitation (3) Statutory construction (l) Savings (m) Authorization of appropriations (n) Health effects studies (o) Monitoring for unregulated contaminants (p) Demonstration project for State of Virginia (q) Small system technical assistance (r) Evaluation

Section 1453—Source Water Quality Assessment (a) Source water assessment (1) Guidance (2) Program requirements (3) Approval, implementation, and monitoring relief (4) Timetable (5) Demonstration project (6) Use of other programs (7) Public availability (b) Approval and disapproval Section 1454—Source Water Petition Program (a) Petition program (1) In general

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736

(b)

(c)

(d)

(e) (f )

TEXT OF THE SDWA AS AMENDED

(A) Establishment (B) Funding (2) Objectives (3) Contaminants addressed by a petition (4) Contents Approval or disapproval of petitions (1) In general (2) Approval (3) Disapproval Grants to support State programs (1) In general (2) Approval Guidance (1) In general (2) Contents of the guidance Authorization of appropriation Statutory construction

Section 1455—Water Conservation Plan (a) Guidelines (b) Loans or grants Section 1456—Assistance to Colonias (a) Definitions (1) Border State (2) Eligible community (b) Grants to alleviate health risks (c) Use of funds (d) Cost sharing (e) Authorization of appropriations Section 1457—Estrogenic Substances Screening Program Section 1458—Drinking Water Studies (a) Subpopulations at greater risk (1) In general (2) Report (b) Biological mechanisms (c) Studies on harmful substances in drinking water

OUTLINE

(1) Development of studies (2) Contents of studies (3) Authorization of appropriations (d) Waterborne disease occurrence study (1) System (2) Training and education (3) Funding

Part F—Additional Requirements to Regulate the Safety of Drinking Water Section 1461—Definitions (1) (2) (3) (4) (5) (6) (7)

Drinking water cooler Lead-free Local educational agency Repair Replacement School Lead-lined tank

Section 1462—Recall of Drinking Water Coolers with Lead-Lined Tanks Section 1463—Drinking Water Coolers Containing Lead (a) Publication of lists (b) Prohibition (c) Criminal penalty (d) Civil penalty Section 1464—Lead Contamination in School Drinking Water (a) Distribution of drinking water cooler list (b) Guidance document and testing protocol (c) Dissemination to schools, etc. (d) Remedial action program (1) Testing and remedying lead contamination (2) Public availability (3) Coolers

737

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TEXT OF THE SDWA AS AMENDED

Section 1465—Federal Assistance for State Programs Regarding Lead Contamination in School Drinking Water (a) School drinking water programs (b) Limits (c) Authorization of appropriations Title XIV—Safety of Public Water Systems SHORT TITLE SECTION 1400. This title may be cited as the ‘‘Safe Drinking Water Act.’’

Part A—Definitions DEFINITIONS 42 USC 300f SECTION 1401. For purposes of this title: (1) The term ‘‘primary drinking water regulation’’ means a regulation which (A) applies to public water systems; (B) specifies contaminants which, in the judgment of the Administrator, may have any adverse effect on the health of persons; (C) specifies for each such contaminant either (i) a maximum contaminant level, if, in the judgment of the Administrator, it is economically or technologically feasible to ascertain the level of such contaminant in water in public water systems; or (ii) if, in the judgment of the Administrator, it is not economically or technologically feasible to so ascertain the level of such contaminant, each treatment technique known to the Administrator which leads to a reduction in the level of such contaminant sufficient to satisfy the requirements of Section 1412; and (D) contains criteria and procedures to assure a supply of drinking water which dependably complies with such maximum contaminant levels; including accepted methods for quality control and testing procedures to ensure compliance with such levels and to ensure proper operation and maintenance of the system, and requirements as to (i) the minimum quality of water which may be taken into the system and (ii) siting for new facilities for public water systems. At any time after promulgation of a regulation referred to in this paragraph, the Administrator may add equally effective quality control and testing procedures by guidance published in the Federal Register. Such procedures shall be treated as an alternative for public water systems to the quality control and testing procedures listed in the regulation. (2) The term ‘‘secondary drinking water regulation’’ means a regulation which applies to public water systems and which specifies the maximum contaminant levels which, in the judgment of the Administrator, are requisite to protect the

DEFINITIONS

739

public welfare. Such regulations may apply to any contaminant in drinking water (A) which may adversely affect the odor or appearance of such water and consequently may cause a substantial number of the persons served by the public water system providing such water to discontinue its use, or (B) which may otherwise adversely affect the public welfare. Such regulations may vary according to geographic and other circumstances. (3) The term ‘‘maximum contaminant level’’ means the maximum permissible level of a contaminant in water which is delivered to any user of a public water system. (4) PUBLIC WATER SYSTEM (A) IN GENERAL. The term ‘‘public water system’’ means a system for the provision to the public of water for human consumption through pipes or other constructed conveyances, if such system has at least fifteen service connections or regularly serves at least twenty-five individuals. Such term includes (i) any collection, treatment, storage, and distribution facilities under control of the operator of such system and used primarily in connection with such system; and (ii) any collection or pretreatment storage facilities not under such control that are used primarily in connection with such system. (B) CONNECTIONS (i) IN GENERAL. For purposes of subparagraph (A), a connection to a system that delivers water by a constructed conveyance other than a pipe shall not be considered a connection, if (I) the water is used exclusively for purposes other than residential uses (consisting of drinking, bathing, and cooking, or other similar uses); (II) the Administrator or the State (in the case of a State exercising primary enforcement responsibility for public water systems) determines that alternative water to achieve the equivalent level of public health protection provided by the applicable national primary drinking water regulation is provided for residential or similar uses for drinking and cooking; or (III) the Administrator or the State (in the case of a State exercising primary enforcement responsibility for public water systems) determines that the water provided for residential or similar uses for drinking, cooking, and bathing is centrally treated or treated at the point of entry by the provider, a pass-through entity, or the user to achieve the equivalent level of protection provided by the applicable national primary drinking water regulations. (ii) IRRIGATION DISTRICTS. An irrigation district in existence prior to May 18, 1994, that provides primarily agricultural service through a piped water system with only incidental residential or similar use shall not be considered to be a public water system if the system or the residential or similar users of the system comply with subclause (II) or (III) of clause (I). (C) TRANSITION PERIOD. A water supplier that would be a public water system only as a result of modifications made to this paragraph by the Safe Drinking Water Act Amendments of 1996 shall not be considered a public water system for purposes of the Act until the date that is two years after the date of enactment of this subparagraph. If a water supplier does not serve 15 service connections [as defined in subparagraphs (A) and (B)] or 25 people at any time after the conclusion of the 2year period, the water supplier shall not be considered a public water system.

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TEXT OF THE SDWA AS AMENDED

(5) The term ‘‘supplier of water’’ means any person who owns or operates a public water system. (6) The term ‘‘contaminant’’ means any physical, chemical, biological, or radiological substance or matter in water. (7) The term ‘‘Administrator’’ means the Administrator of the Environmental Protection Agency. (8) The term ‘‘Agency’’ means the U.S. Environmental Protection Agency. (9) The term ‘‘Council’’ means the National Drinking Water Advisory Council established under Section 1446. (10) The term ‘‘municipality’’ means a city, town, or other public body created by or pursuant to State law, or an Indian Tribe authorized by law. (11) The term ‘‘Federal agency’’ means any department, agency, or instrumentality of the United States. (12) The term ‘‘person’’ means an individual, corporation, company, association, partnership, State, municipality, or Federal agency (and includes officers, employees, and agents of any corporation, company, association, State, municipality, or Federal agency). (13)(A) Except as provided in subparagraph (B), the term ‘‘State’’ includes, in addition to the several States, only the District of Columbia, Guam, the Commonwealth of Puerto Rico, the Northern Mariana Islands, the Virgin Islands, American Samoa, and the Trust Territory of the Pacific Islands. (B) For purposes of Section 1452, the term ‘‘State’’ means each of the 50 States, the District of Columbia, and the Commonwealth of Puerto Rico. (14) The term ‘‘Indian Tribe’’ means any Indian Tribe having a Federally recognized governing body carrying out substantial governmental duties and powers over any area. For purposes of Section 1452, the term includes any Native village {as defined in Sec. 3(c) of the Alaska Native Claims Settlement Act (43 USC 1602(c)}. (15) Community Water System. The term ‘‘community water system’’ means a public water system that (A) Serves at least 15 service connections used by year-round residents of the area served by the system; or (B) regularly serves at least 25 year-round residents. (16) Noncommunity Water System. The term ‘‘noncommunity water system’’ means a public water system that is not a community water system.

Part B—Public Water Systems COVERAGE 42 USC 300g SECTION 1411. Subject to Sections 1415 and 1416, national primary drinking water regulations under this part shall apply to each public water system in each State; except that such regulations shall not apply to a public water system

NATIONAL DRINKING WATER REGULATIONS

741

(1) which consists only of distribution and storage facilities (and does not have any collection and treatment facilities) (2) which obtains all of its water from, but is not owned or operated by, a public water system to which such regulations apply; (3) which does not sell water to any person; and (4) which is not a carrier which conveys passengers in interstate commerce. NATIONAL DRINKING WATER REGULATIONS 42 USC 300g-1 SECTION 1412. (a)(1) Effective on the enactment of the Safe Drinking Water Act Amendments of 1986, each national interim or revised primary drinking water regulation promulgated under this section before such enactment shall be deemed to be a national primary drinking water regulation under subsection (b). No such regulation shall be required to comply with the standards set forth in subsection (b)(4) unless such regulation is amended to establish a different maximum contaminant level after the enactment of such amendments. (2) After the enactment of the Safe Drinking Water Act Amendments of 1986, each recommended maximum contaminant level published before the enactment of such amendments shall be treated as a maximum contaminant level goal. (3) Whenever a national primary drinking water regulation is proposed under subsection (b) for any contaminant, the maximum contaminant level goal for such contaminant shall be proposed simultaneously. Whenever a national primary drinking water regulation is promulgated under subsection (b) for any contaminant, the maximum contaminant level goal for such contaminant shall be published simultaneously. (4) Paragraph (3) shall not apply to any recommended maximum contaminant level published before the enactment of the Safe Drinking Water Act Amendments of 1986. (b) STANDARDS (1) IDENTIFICATION OF CONTAMINANTS FOR LISTING (A) GENERAL AUTHORITY. The Administrator shall, in accordance with the procedures established by this subsection, publish a maximum contaminant level goal and promulgate a national primary drinking water regulation for a contaminant [other than a contaminant referred to in paragraph (2) for which a national primary drinking water regulation has been promulgated as of the date of enactment of the Safe Drinking Water Act Amendments of 1996] if the Administrator determines that (i) the contaminant may have an adverse effect on the health of persons; (ii) the contaminant is known to occur or there is a substantial likelihood that the contaminant will occur in public water systems with a frequency and at levels of public health concern; and (iii) in the sole judgment of the Administrator, regulation of such contaminant presents a meaningful opportunity for health risk reduction for persons served by public water systems.

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(B) REGULATION OF UNREGULATED CONTAMINANTS (i) LISTING OF CONTAMINANTS FOR CONSIDERATION. (I) Not later than 18 months after the date of enactment of the Safe Drinking Water Act Amendments of 1996 and every 5 years thereafter, the Administrator, after consultation with the scientific community, including the Science Advisory Board, after notice and opportunity for public comment, and after considering the occurrence database established under Section 1445(g), shall publish a list of contaminants which, at the time of publication, are not subject to any proposed or promulgated national primary drinking water regulation, which are known or anticipated to occur in public water systems, and which may require regulation under this title. (II) The unregulated contaminants considered under subclause (I) shall include, but not be limited to, substances referred to in Section 101(14) of the Comprehensive Environmental Response, Compensation, and Liability Act of 1980, and substances registered as pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act. (III) The Administrator’s decision whether or not to select an unregulated contaminant for a list under this clause shall not be subject to judicial review. (ii) DETERMINATION TO REGULATE. (I) Not later than 5 years after the date of enactment of the Safe Drinking Water Act Amendments of 1996, and every 5 years thereafter, the Administrator shall, after notice of the preliminary determination and opportunity for public comment, for not fewer than 5 contaminants included on the list published under clause (i), make determinations of whether or not to regulate such contaminants. (II) A determination to regulate a contaminant shall be based on findings that the criteria of clauses (i), (ii), and (iii) of subparagraph (A) are satisfied. Such findings shall be based on the best available public health information, including the occurrence database established under Section 1445(g). (III) The Administrator may make a determination to regulate a contaminant that does not appear on a list under clause (i) if the determination to regulate is made pursuant to subclause (II). (IV) A determination under this clause not to regulate a contaminant shall be considered final agency action and subject to judicial review. (iii) REVIEW. Each document setting forth the determination for a contaminant under clause (ii) shall be available for public comment at such time as the determination is published. (C) PRIORITIES. In selecting unregulated contaminants for consideration under subparagraph (B), the Administrator shall select contaminants that present the greatest public health concern. The Administrator, in making such selection, shall take into consideration, among other factors of public health concern, the effect of such contaminants upon subgroups that comprise a meaningful portion of the general population (such as infants, children, pregnant women, the elderly, individuals with a history of serious illness, or other subpopulations) that are identifiable as being at greater risk of adverse health effects due to exposure to contaminants in drinking water than the general population.

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(D) URGENT THREATS TO PUBLIC HEALTH. The Administrator may promulgate an interim national primary drinking water regulation for a contaminant without making a determination for the contaminant under paragraph (4)(C), or completing the analysis under paragraph (3)(C), to address an urgent threat to public health as determined by the Administrator after consultation with and written response to any comments provided by the Secretary of Health and Human Services, acting through the director of the Centers for Disease Control and Prevention or the director of the National Institutes of Health. A determination for any contaminant in accordance with paragraph (4)(C) subject to an interim regulation under this subparagraph shall be issued, and a completed analysis meeting the requirements of paragraph (3)(C) shall be published, not later than 3 years after the date on which the regulation is promulgated and the regulation shall be repromulgated, or revised if appropriate, not later than 5 years after that date. (E) REGULATION. For each contaminant that the Administrator determines to regulate under subparagraph (B), the Administrator shall publish maximum contaminant level goals and promulgate, by rule, national primary drinking water regulations under this subsection. The Administrator shall propose the maximum contaminant level goal and national primary drinking water regulation for a contaminant not later than 24 months after the determination to regulate under subparagraph (B), and may publish such proposed regulation concurrent with the determination to regulate. The Administrator shall publish a maximum contaminant level goal and promulgate a national primary drinking water regulation within 18 months after the proposal thereof. The Administrator, by notice in the Federal Register, may extend the deadline for such promulgation for up to 9 months. (F) HEALTH ADVISORIES AND OTHER ACTIONS. The Administrator may publish health advisories (which are not regulations) or take other appropriate actions for contaminants not subject to any national primary drinking water regulation. (2) SCHEDULES AND DEADLINES (A) IN GENERAL. In the case of the contaminants listed in the Advance Notice of Proposed Rulemaking published in Volume 47, Federal Register, page 9352, and in Volume 48, Federal Register, page 45502, the Administrator shall publish maximum contaminant level goals and promulgate national primary drinking water regulations (i) not later than 1 year after June 19, 1986, for not fewer than 9 of the listed contaminants; (ii) not later than 2 years after June 19, 1986, for not fewer than 40 of the listed contaminants; and (iii) not later than 3 years after June 19, 1986, for the remainder of the listed contaminants. (B) SUBSTITUTION OF CONTAMINANTS. If the Administrator identifies a drinking water contaminant the regulation of which, in the judgment of the Administrator, is more likely to be protective of public health [taking into account the schedule for regulation under subparagraph (A)] than a contaminant referred to in

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subparagraph (A), the Administrator may publish a maximum contaminant level goal and promulgate a national primary drinking water regulation for the identified contaminant in lieu of regulating the contaminant referred to in subparagraph (A). Substitutions may be made for not more than 7 contaminants referred to in subparagraph (A). Regulation of a contaminant identified under this subparagraph shall be in accordance with the schedule applicable to the contaminant for which the substitution is made. (C) DISINFECTANTS AND DISINFECTION BYPRODUCTS. The Administrator shall promulgate an Interim Enhanced Surface Water Treatment Rule, a Final Enhanced Surface Water Treatment Rule, a Stage I Disinfectants and Disinfection Byproducts Rule, and a Stage II Disinfectants and Disinfection Byproducts Rule in accordance with the schedule published in Volume 59, Federal Register, page 6361 (February 10, 1994), in Table III.13 of the proposed Information Collection Rule. If a delay occurs with respect to the promulgation of any rule in the schedule referred to in this subparagraph, all subsequent rules shall be completed as expeditiously as practicable but no later than a revised date that reflects the interval or intervals for the rules in the schedule. (3) RISK ASSESSMENT, MANAGEMENT, AND COMMUNICATION (A) USE OF SCIENCE IN DECISIONMAKING. In carrying out this section, and, to the degree that an Agency action is based on science, the Administrator shall use (i) the best available, peer-reviewed science and supporting studies conducted in accordance with sound and objective scientific practices; and (ii) data collected by accepted methods or best available methods (if the reliability of the method and the nature of the decision justifies use of the data). (B) PUBLIC INFORMATION. In carrying out this section, the Administrator shall ensure that the presentation of information on public health effects is comprehensive, informative, and understandable. The Administrator shall, in a document made available to the public in support of a regulation promulgated under this section, specify, to the extent practicable (i) each population addressed by any estimate of public health effects; (ii) the expected risk or central estimate of risk for the specific populations; (iii) each appropriate upper-bound or lower-bound estimate of risk; (iv) each significant uncertainty identified in the process of the assessment of public health effects and studies that would assist in resolving the uncertainty; and (v) peer-reviewed studies known to the Administrator that support, are directly relevant to, or fail to support any estimate of public health effects and the methodology used to reconcile inconsistencies in the scientific data. (C) HEALTH RISK REDUCTION AND COST ANALYSIS (i) MAXIMUM CONTAMINANT LEVELS. When proposing any national primary drinking water regulation that includes a maximum contaminant level, the Administrator shall, with respect to a maximum contaminant level that is being considered in accordance with paragraph (4) and each alternative maximum contaminant level that is being considered pursuant to paragraph (5) or (6)(A), publish, seek public comment on, and use for the purposes of paragraphs (4), (5), and (6) an analysis of each of the following:

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(I) Quantifiable and nonquantifiable health risk reduction benefits for which there is a factual basis in the rulemaking record to conclude that such benefits are likely to occur as the result of treatment to comply with each level. (II) Quantifiable and nonquantifiable health risk reduction benefits for which there is a factual basis in the rulemaking record to conclude that such benefits are likely to occur from reductions in co-occurring contaminants that may be attributed solely to compliance with the maximum contaminant level, excluding benefits resulting from compliance with other proposed or promulgated regulations. (III) Quantifiable and nonquantifiable costs for which there is a factual basis in the rulemaking record to conclude that such costs are likely to occur solely as a result of compliance with the maximum contaminant level, including monitoring, treatment, and other costs and excluding costs resulting from compliance with other proposed or promulgated regulations. (IV) The incremental costs and benefits associated with each alternative maximum contaminant level considered. (V) The effects of the contaminant on the general population and on groups within the general population such as infants, children, pregnant women, the elderly, individuals with a history of serious illness, or other subpopulations that are identified as likely to be at greater risk of adverse health effects due to exposure to contaminants in drinking water than the general population. (VI) Any increased health risk that may occur as the result of compliance, including risks associated with co-occurring contaminants. (VII) Other relevant factors, including the quality and extent of the information, the uncertainties in the analysis supporting subclauses (I) through (VI), and factors with respect to the degree and nature of the risk. (ii) TREATMENT TECHNIQUES. When proposing a national primary drinking water regulation that includes a treatment technique in accordance with paragraph (7)(A), the Administrator shall publish and seek public comment on an analysis of the health risk reduction benefits and costs likely to be experienced as the result of compliance with the treatment technique and alternative treatment techniques that are being considered, taking into account, as appropriate, the factors described in clause (i). (iii) APPROACHES TO MEASURE AND VALUE BENEFITS. The Administrator may identify valid approaches for the measurement and valuation of benefits under this subparagraph, including approaches to identify consumer willingness to pay for reductions in health risks from drinking water contaminants. (iv) AUTHORIZATION. There are authorized to be appropriated to the Administrator, acting through the Office of Ground Water and Drinking Water, to conduct studies, assessments, and analyses in support of regulations or the development of methods, $35,000,000 for each of fiscal years 1996 through 2003. (4) GOALS AND STANDARDS (A) MAXIMUM CONTAMINANT LEVEL GOALS. Each maximum contaminant level goal established under this subsection shall be set at the level at which no known or anticipated adverse effects on the health of persons occur and which allows an adequate margin of safety.

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(B) MAXIMUM CONTAMINANT LEVELS. Except as provided in paragraphs (5) and (6), each national primary drinking water regulation for a contaminant for which a maximum contaminant level goal is established under this subsection shall specify a maximum contaminant level for such contaminant which is as close to the maximum contaminant level goal as is feasible. (C) DETERMINATION. At the time the Administrator proposes a national primary drinking water regulation under this paragraph, the Administrator shall publish a determination as to whether the benefits of the maximum contaminant level justify, or do not justify, the costs based on the analysis conducted under paragraph (3)(C). (D) DEFINITION OF FEASIBLE. For the purposes of this subsection, the term ‘‘feasible’’ means feasible with the use of the best technology, treatment techniques, and other means which the Administrator finds, after examination for efficacy under field conditions and not solely under laboratory conditions, are available (taking cost into consideration). For the purpose of this paragraph, granular activated carbon is feasible for the control of synthetic organic chemicals, and any technology, treatment technique, or other means found to be the best available for the control of synthetic organic chemicals must be at least as effective in controlling synthetic organic chemicals as granular activated carbon. (E) FEASIBLE TECHNOLOGIES (i) IN GENERAL. Each national primary drinking water regulation which establishes a maximum contaminant level shall list the technology, treatment techniques, and other means which the Administrator finds to be feasible for purposes of meeting such maximum contaminant level, but a regulation under this subsection shall not require that any specified technology, treatment technique, or other means be used for purposes of meeting such maximum contaminant level. (ii) LIST OF TECHNOLOGIES FOR SMALL SYSTEMS. The Administrator shall include in the list any technology, treatment technique, or other means that is affordable, as determined by the Administrator in consultation with the States, for small public water systems serving (i) A population of 10,000 or fewer but more than 3300; (ii) A population of 3300 or fewer but more than 500; and (iii) A population of 500 or fewer but more than 25; and that achieves compliance with the maximum contaminant level or treatment technique, including packaged or modular systems and point-of-entry or point-ofuse treatment units. Point-of-entry and point-of-use treatment units shall be owned, controlled, and maintained by the public water system or by a person under contract with the public water system to ensure proper operation and maintenance and compliance with the maximum contaminant level or treatment technique and equipped with mechanical warnings to ensure that customers are automatically notified of operational problems. The Administrator shall not include in the list any point-of-use treatment technology, treatment technique, or other means to achieve compliance with a maximum contaminant level or treatment technique

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requirement for a microbial contaminant (or an indicator of a microbial contaminant). If the American National Standards Institute has issued product standards applicable to a specific type of point-of-entry or point-of-use treatment unit, individual units of that type shall not be accepted for compliance with a maximum contaminant level or treatment technique requirement unless they are independently certified in accordance with such standards. In listing any technology, treatment technique, or other means pursuant to this clause, the Administrator shall consider the quality of the source water to be treated. (iii) LIST OF TECHNOLOGIES THAT ACHIEVE COMPLIANCE. Except as provided in clause (v), not later than 2 years after the date of enactment of this clause and after consultation with the States, the Administrator shall issue a list of technologies that achieve compliance with the maximum contaminant level or treatment technique for each category of public water systems described in subclauses (I), (II), and (III) of clause (ii) for each national primary drinking water regulation promulgated prior to the date of enactment of this paragraph. (iv) ADDITIONAL TECHNOLOGIES. The Administrator may, at any time after a national primary drinking water regulation has been promulgated, supplement the list of technologies describing additional or new or innovative treatment technologies that meet the requirements of this paragraph for categories of small public water systems described in subclauses (I), (II), and (III) of clause (ii) that are subject to the regulation. (v) TECHNOLOGIES THAT MEET SURFACE WATER TREATMENT RULE. Within one year after the date of enactment of this clause, the Administrator shall list technologies that meet the Surface Water Treatment Rule for each category of public water systems described in subclauses (I), (II), and (III) of clause (ii). (5) ADDITIONAL HEALTH RISK CONSIDERATIONS (A) IN GENERAL. Notwithstanding paragraph (4), the Administrator may establish a maximum contaminant level for a contaminant at a level other than the feasible level, if the technology, treatment techniques, and other means used to determine the feasible level would result in an increase in the health risk from drinking water by (i) increasing the concentration of other contaminants in drinking water; or (ii) interfering with the efficacy of drinking water treatment techniques or processes that are used to comply with other national primary drinking water regulations. (B) ESTABLISHMENT OF LEVEL. If the Administrator establishes a maximum contaminant level or levels or requires the use of treatment techniques for any contaminant or contaminants pursuant to the authority of this paragraph (i) the level or levels or treatment techniques shall minimize the overall risk of adverse health effects by balancing the risk from the contaminant and the risk from other contaminants the concentrations of which may be affected by the use of a treatment technique or process that would be employed to attain the maximum contaminant level or levels; and (ii) the combination of technology, treatment techniques, or other means required to meet the level or levels shall not be more stringent than is feasible (as defined in paragraph (4)(D)).

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(6) ADDITIONAL HEALTH RISK REDUCTION AND COST CONSIDERATIONS (A) IN GENERAL. Notwithstanding paragraph (4), if the Administrator determines based on an analysis conducted under paragraph (3)(C) that the benefits of a maximum contaminant level promulgated in accordance with paragraph (4) would not justify the costs of complying with the level, the Administrator may, after notice and opportunity for public comment, promulgate a maximum contaminant level for the contaminant that maximizes health risk reduction benefits at a cost that is justified by the benefits. (B) EXCEPTION. The Administrator shall not use the authority of this paragraph to promulgate a maximum contaminant level for a contaminant, if the benefits of compliance with a national primary drinking water regulation for the contaminant that would be promulgated in accordance with paragraph (4) experienced by (i) persons served by large public water systems; and (ii) persons served by such other systems as are unlikely, based on information provided by the States, to receive a variance under Section 1415(e) (relating to small system variances) would justify the costs to the systems of complying with the regulation. This subparagraph shall not apply if the contaminant is found almost exclusively in small systems eligible under Section 1415(e) for a small system variance. (C) DISINFECTANTS AND DISINFECTION BYPRODUCTS. The Administrator may not use the authority of this paragraph to establish a maximum contaminant level in a Stage I or Stage II national primary drinking water regulation [as described in paragraph (2)(C)] for contaminants that are disinfectants or disinfection byproducts, or to establish a maximum contaminant level or treatment technique requirement for the control of cryptosporidium. The authority of this paragraph may be used to establish regulations for the use of disinfection by systems relying on groundwater sources as required by paragraph (8). (D) JUDICIAL REVIEW. A determination by the Administrator that the benefits of a maximum contaminant level or treatment requirement justify or do not justify the costs of complying with the level shall be reviewed by the court pursuant to Section 1448 only as part of a review of a final national primary drinking water regulation that has been promulgated based on the determination and shall not be set aside by the court under that section unless the court finds that the determination is arbitrary and capricious. (7)(A) The Administrator is authorized to promulgate a national primary drinking water regulation that requires the use of a treatment technique in lieu of establishing a maximum contaminant level, if the Administrator makes a finding that it is not economically or technologically feasible to ascertain the level of the contaminant. In such case, the Administrator shall identify those treatment techniques which, in the Administrator’s judgment, would prevent known or anticipated adverse effects on the health of persons to the extent feasible. Such regulations shall specify each treatment technique known to the Administrator which meets the requirements of this para-

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graph, but the Administrator may grant a variance from any specified treatment technique in accordance with Section 1415(a)(3). (B) Any schedule referred to in this subsection for the promulgation of a national primary drinking water regulation for any contaminant shall apply in the same manner if the regulation requires a treatment technique in lieu of establishing a maximum contaminant level. (C)(i) Not later than 18 months after the enactment of the Safe Drinking Water Act Amendments of 1986, the Administrator shall propose and promulgate national primary drinking water regulations specifying criteria under which filtration (including coagulation and sedimentation, as appropriate) is required as a treatment technique for public water systems supplied by surface water sources. In promulgating such rules, the Administrator shall consider the quality of source waters, protection afforded by watershed management, treatment practices (such as disinfection and length of water storage) and other factors relevant to protection of health. (ii) In lieu of the provisions of Section 1415 the Administrator shall specify procedures by which the State determines which public water systems within its jurisdiction shall adopt filtration under the criteria of clause (i). The State may require the public water system to provide studies or other information to assist in this determination. The procedures shall provide notice and opportunity for public hearing on this determination. If the State determines that filtration is required, the State shall prescribe a schedule for compliance by the public water system with the filtration requirement. A schedule shall require compliance within 18 months of a determination made under clause (iii). (iii) Within 18 months from the time that the Administrator establishes the criteria and procedures under this subparagraph, a State with primary enforcement responsibility shall adopt any necessary regulations to implement this subparagraph. Within 12 months of adoption of such regulations the State shall make determinations regarding filtration for all the public water systems within its jurisdiction supplied by surface waters. (iv) If a State does not have primary enforcement responsibility for public water systems, the Administrator shall have the same authority to make the determination in clause (ii) in such State as the State would have under that clause. Any filtration requirement or schedule under this subparagraph shall be treated as if it were a requirement of a national primary drinking water regulation. (v) As an additional alternative to the regulations promulgated pursuant to clauses (i) and (iii), including the criteria for avoiding filtration contained in 40 CFR 141.71, a State exercising primary enforcement responsibility for public water systems may, on a case-by-case basis, and after notice and opportunity for public comment, establish treatment requirements as an alternative to filtration in the case of systems having uninhabited, undeveloped watersheds in consolidated ownership, and having control over access to, and activities in, those watersheds, if the State determines (and the Administrator concurs) that the quality of the source water and the alternative treatment requirements established by the State ensure greater removal or inactivation efficiencies of pathogenic organisms for which national primary drinking water regulations have been promulgated or that are of public health concern

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than would be achieved by the combination of filtration and chlorine disinfection (in compliance with this section). (8) DISINFECTION. At any time after the end of the 3-year period that begins on the date of enactment of the Safe Drinking Water Act Amendments of 1996, but not later than the date on which the Administrator promulgates a Stage II rulemaking for disinfectants and disinfection byproducts [as described in paragraph (2)(C)], the Administrator shall also promulgate national primary drinking water regulations requiring disinfection as a treatment technique for all public water systems, including surface water systems and, as necessary, groundwater systems. After consultation with the States, the Administrator shall (as part of the regulations) promulgate criteria that the Administrator, or a State that has primary enforcement responsibility under Section 1413, shall apply to determine whether disinfection shall be required as a treatment technique for any public water system served by groundwater. The Administrator shall simultaneously promulgate a rule specifying criteria that will be used by the Administrator (or delegated State authorities) to grant variances from this requirement according to the provisions of Sections 1415(a)(1)(B) and 1415(a)(3). In implementing Section 1442(e) the Administrator or the delegated State authority shall, where appropriate, give special consideration to providing technical assistance to small public water systems in complying with the regulations promulgated under this paragraph. (9) REVIEW AND REVISION. The Administrator shall, not less often than every 6 years, review and revise, as appropriate, each national primary drinking water regulation promulgated under this title. Any revision of a national primary drinking water regulation shall be promulgated in accordance with this section, except that each revision shall maintain, or provide for greater, protection of the health of persons. (10) EFFECTIVE DATE. A national primary drinking water regulation promulgated under this section (and any amendment thereto) shall take effect on the date that is 3 years after the date on which the regulation is promulgated unless the Administrator determines that an earlier date is practicable, except that the Administrator, or a State (in the case of an individual system), may allow up to 2 additional years to comply with a maximum contaminant level or treatment technique if the Administrator or State (in the case of an individual system) determines that additional time is necessary for capital improvements. (11) No national primary drinking water regulation may require the addition of any substance for preventive healthcare purposes unrelated to contamination of drinking water. (12) CERTAIN CONTAMINANTS (A) ARSENIC (i) SCHEDULE AND STANDARD. Notwithstanding the deadlines set forth in paragraph (1), the Administrator shall promulgate a national primary drinking water regulation for arsenic pursuant to this subsection, in accordance with the schedule established by this paragraph. (ii) STUDY PLAN. Not later than 180 days after the date of enactment of this paragraph, the Administrator shall develop a comprehensive plan for study in

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support of drinking water rulemaking to reduce the uncertainty in assessing health risks associated with exposure to low levels of arsenic. In conducting such study, the Administrator shall consult with the National Academy of Sciences, other Federal agencies, and interested public and private entities. (iii) COOPERATIVE AGREEMENTS. In carrying out the study plan, the Administrator may enter into cooperative agreements with other Federal agencies, State and local governments, and other interested public and private entities. (iv) PROPOSED REGULATIONS. The Administrator shall propose a national primary drinking water regulation for arsenic not later than January 1, 2000. (v) FINAL REGULATIONS. Not later than January 1, 2001, after notice and opportunity for public comment, the Administrator shall promulgate a national primary drinking water regulation for arsenic. (vi) AUTHORIZATION. There are authorized to be appropriated $2,500,000 for each of fiscal years 1997 through 2000 for the studies required by this paragraph. (B) SULFATE (i) ADDITIONAL STUDY. Prior to promulgating a national primary drinking water regulation for sulfate, the Administrator and the Director of the Centers for Disease Control and Prevention shall jointly conduct an additional study to establish a reliable dose–response relationship for the adverse human health effects that may result from exposure to sulfate in drinking water, including the health effects that may be experienced by groups within the general population (including infants and travelers) that are potentially at greater risk of adverse health effects as the result of such exposure. The study shall be conducted in consultation with interested States, shall be based on the best available, peer-reviewed science and supporting studies conducted in accordance with sound and objective scientific practices, and shall be completed not later than 30 months after the date of enactment of the Safe Drinking Water Act Amendments of 1996. (ii) DETERMINATION. The Administrator shall include sulfate among the 5 or more contaminants for which a determination is made pursuant to paragraph (3)(B) not later than 5 years after the date of enactment of the Safe Drinking Water Act Amendments of 1996. (iii) PROPOSED AND FINAL RULE. Notwithstanding the deadlines set forth in paragraph (2), the Administrator may, pursuant to the authorities of this subsection and after notice and opportunity for public comment, promulgate a final national primary drinking water regulation for sulfate. Any such regulation shall include requirements for public notification and options for the provision of alternative water supplies to populations at risk as a means of complying with the regulation in lieu of a best available treatment technology or other means. (13) RADON IN DRINKING WATER (A) NATIONAL PRIMARY DRINKING WATER REGULATION. Notwithstanding paragraph (2), the Administrator shall withdraw any national primary drinking water regulation for radon proposed prior to the date of enactment of this paragraph and shall propose and promulgate a regulation for radon under this section, as amended by the Safe Drinking Water Act Amendments of 1996.

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(B) RISK ASSESSMENT AND STUDIES (i) ASSESSMENT BY NAS. Prior to proposing a national primary drinking water regulation for radon, the Administrator shall arrange for the National Academy of Sciences to prepare a risk assessment for radon in drinking water using the best available science in accordance with the requirements of paragraph (3). The risk assessment shall consider each of the risks associated with exposure to radon from drinking water and consider studies on the health effects of radon at levels and under conditions likely to be experienced through residential exposure. The risk assessment shall be peer-reviewed. (ii) STUDY OF OTHER MEASURES. The Administrator shall arrange for the National Academy of Sciences to prepare an assessment of the health risk reduction benefits associated with various mitigation measures to reduce radon levels in indoor air. The assessment may be conducted as part of the risk assessment authorized by clause (i) and shall be used by the Administrator to prepare the guidance and approve State programs under subparagraph (G). (iii) OTHER ORGANIZATION. If the National Academy of Sciences declines to prepare the risk assessment or studies required by this subparagraph, the Administrator shall enter into a contract or cooperative agreement with another independent, scientific organization to prepare such assessments or studies. (C) HEALTH RISK REDUCTION AND COST ANALYSIS. Not later than 30 months after the date of enactment of this paragraph, the Administrator shall publish, and seek public comment on, a health risk reduction and cost analysis meeting the requirements of paragraph (3)(C) for potential maximum contaminant levels that are being considered for radon in drinking water. The Administrator shall include a response to all significant public comments received on the analysis with the preamble for the proposed rule published under subparagraph (D). (D) PROPOSED REGULATION. Not later than 36 months after the date of enactment of this paragraph, the Administrator shall propose a maximum contaminant level goal and a national primary drinking water regulation for radon pursuant to this section. (E) FINAL REGULATION. Not later than 12 months after the date of the proposal under subparagraph (D), the Administrator shall publish a maximum contaminant level goal and promulgate a national primary drinking water regulation for radon pursuant to this section based on the risk assessment prepared pursuant to subparagraph (B) and the health risk reduction and cost analysis published pursuant to subparagraph (C). In considering the risk assessment and the health risk reduction and cost analysis in connection with the promulgation of such a standard, the Administrator shall take into account the costs and benefits of control programs for radon from other sources. (F) ALTERNATIVE MAXIMUM CONTAMINANT LEVEL. If the maximum contaminant level for radon in drinking water promulgated pursuant to subparagraph (E) is more stringent than necessary to reduce the contribution to radon in indoor air from drinking water to a concentration that is equivalent to the national average concentration of radon in outdoor air, the Administrator shall, simultaneously with the promulgation of such level, promulgate an alternative maximum contaminant

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level for radon that would result in a contribution of radon from drinking water to radon levels in indoor air equivalent to the national average concentration of radon in outdoor air. If the Administrator promulgates an alternative maximum contaminant level under this subparagraph, the Administrator shall, after notice and opportunity for public comment and in consultation with the States, publish guidelines for State programs, including criteria for multimedia measures to mitigate radon levels in indoor air, to be used by the States in preparing programs under subparagraph (G). The guidelines shall take into account data from existing radon mitigation programs and the assessment of mitigation measures prepared under subparagraph (B). (G) MULTIMEDIA RADON MITIGATION PROGRAMS (i) IN GENERAL. A State may develop and submit a multimedia program to mitigate radon levels in indoor air for approval by the Administrator under this subparagraph. If, after notice and the opportunity for public comment, such program is approved by the Administrator, public water systems in the State may comply with the alternative maximum contaminant level promulgated under subparagraph (F) in lieu of the maximum contaminant level in the national primary drinking water regulation promulgated under subparagraph (E). (ii) ELEMENTS OF PROGRAMS. State programs may rely on a variety of mitigation measures including public education, testing, training, technical assistance, remediation grant and loan or incentive programs, or other regulatory or nonregulatory measures. The effectiveness of elements in State programs shall be evaluated by the Administrator based on the assessment prepared by the National Academy of Sciences under subparagraph (B) and the guidelines published by the Administrator under subparagraph (F). (iii) APPROVAL. The Administrator shall approve a State program submitted under this paragraph if the health risk reduction benefits expected to be achieved by the program are equal to or greater than the health risk reduction benefits that would be achieved if each public water system in the State complied with the maximum contaminant level promulgated under subparagraph (E). The Administrator shall approve or disapprove a program submitted under this paragraph within 180 days of receipt. A program that is not disapproved during such period shall be deemed approved. A program that is disapproved may be modified to address the objections of the Administrator and be resubmitted for approval. (iv) REVIEW. The Administrator shall periodically, but not less often than every 5 years, review each multimedia mitigation program approved under this subparagraph to determine whether it continues to meet the requirements of clause (iii) and shall, after written notice to the State and an opportunity for the State to correct any deficiency in the program, withdraw approval of programs that no longer comply with such requirements. (v) EXTENSION. If, within 90 days after the promulgation of an alternative maximum contaminant level under subparagraph (F), the Governor of a State submits a letter to the Administrator committing to develop a multimedia mitigation program under this subparagraph, the effective date of the national primary drinking water regulation for radon in the State that would be applicable under paragraph (10) shall be extended for a period of 18 months.

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(vi) LOCAL PROGRAMS. In the event that a State chooses not to submit a multimedia mitigation program for approval under this subparagraph or has submitted a program that has been disapproved, any public water system in the State may submit a program for approval by the Administrator according to the same criteria, conditions, and approval process that would apply to a State program. The Administrator shall approve a multimedia mitigation program if the health risk reduction benefits expected to be achieved by the program are equal to or greater than the health risk reduction benefits that would result from compliance by the public water system with the maximum contaminant level for radon promulgated under subparagraph (E). (14) RECYCLING OF FILTER BACKWASH. The Administrator shall promulgate a regulation to govern the recycling of filter backwash water within the treatment process of a public water system. The Administrator shall promulgate such regulation not later than 4 years after the date of enactment of the Safe Drinking Water Act Amendments of 1996 unless such recycling has been addressed by the Administrator’s Enhanced Surface Water Treatment Rule prior to such date. (15) VARIANCE TECHNOLOGIES (A) IN GENERAL. At the same time as the Administrator promulgates a national primary drinking water regulation for a contaminant pursuant to this section, the Administrator shall issue guidance or regulations describing the best treatment technologies, treatment techniques, or other means (referred to in this paragraph as ‘‘variance technology’’) for the contaminant that the Administrator finds, after examination for efficacy under field conditions and not solely under laboratory conditions, are available and affordable, as determined by the Administrator in consultation with the States, for public water systems of varying size, considering the quality of the source water to be treated. The Administrator shall identify such variance technologies for public water systems serving (i) a population of 10,000 or fewer but more than 3300; (ii) a population of 3300 or fewer but more than 500; and (iii) a population of 500 or fewer but more than 25, if, considering the quality of the source water to be treated, no treatment technology is listed for public water systems of that size under paragraph (4)(E). Variance technologies identified by the Administrator pursuant to this paragraph may not achieve compliance with the maximum contaminant level or treatment technique requirement of such regulation, but shall achieve the maximum reduction or inactivation efficiency that is affordable considering the size of the system and the quality of the source water. The guidance or regulations shall not require the use of a technology from a specific manufacturer or brand. (B) LIMITATION. The Administrator shall not identify any variance technology under this paragraph, unless the Administrator has determined, considering the quality of the source water to be treated and the expected useful life of the technology, that the variance technology is protective of public health.

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(C) ADDITIONAL INFORMATION. The Administrator shall include in the guidance or regulations identifying variance technologies under this paragraph any assumptions supporting the public health determination referred to in subparagraph (B), where such assumptions concern the public water system to which the technology may be applied, or its source waters. The Administrator shall provide any assumptions used in determining affordability, taking into consideration the number of persons served by such systems. The Administrator shall provide as much reliable information as practicable on performance, effectiveness, limitations, costs, and other relevant factors, including the applicability of variance technology to waters from surface and underground sources. (D) REGULATIONS AND GUIDANCE. Not later than 2 years after the date of enactment of this paragraph and after consultation with the States, the Administrator shall issue guidance or regulations under subparagraph (A) for each national primary drinking water regulation promulgated prior to the date of enactment of this paragraph for which a variance may be granted under section 1415(e). The Administrator may, at any time after a national primary drinking water regulation has been promulgated, issue guidance or regulations describing additional variance technologies. The Administrator shall, not less often than every 7 years, or upon receipt of a petition supported by substantial information, review variance technologies identified under this paragraph. The Administrator shall issue revised guidance or regulations if new or innovative variance technologies become available that meet the requirements of this paragraph and achieve an equal or greater reduction or inactivation efficiency than the variance technologies previously identified under this subparagraph. No public water system shall be required to replace a variance technology during the useful life of the technology for the sole reason that a more efficient variance technology has been listed under this subparagraph. (c) The Administrator shall publish proposed national secondary drinking water regulations within 270 days after the date of enactment of this title. Within 90 days after publication of any such regulation, he shall promulgate such regulation with such modifications as he deems appropriate. Regulations under this subsection may be amended from time to time. (d) Regulations under this section shall be prescribed in accordance with Section 553 of Title 5, United States Code (relating to rulemaking), except that the Administrator shall provide opportunity of public hearing prior to promulgation of such regulations. In proposing and promulgating regulations under this section, the Administrator shall consult with the Secretary and the National Drinking Water Advisory Council. (e) The Administrator shall request comments from the Science Advisory Board (established under the Environmental Research, Development, and Demonstration Act of 1978) prior to proposal of a maximum contaminant level goal and national primary drinking water regulation. The Board shall respond, as it deems appropriate, within the time period applicable for promulgation of the national primary drinking water standard concerned. This subsection shall, under no circumstances, be used to delay final promulgation of any national primary drinking water standard.

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THE PRIMARY ENFORCEMENT RESPONSIBILITY 42 USC 300g-2 SECTION 1413. (a) For purposes of this title, a State has primary enforcement responsibility for public water systems during any period for which the Administrator determines (pursuant to regulations prescribed under subsection (b)) that such State (1) has adopted drinking water regulations that are no less stringent than the national primary drinking water regulations promulgated by the Administrator under subsections (a) and (b) of Section 1412 not later than 2 years after the date on which the regulations are promulgated by the Administrator, except that the Administrator may provide for an extension of not more than 2 years if, after submission and review of appropriate, adequate documentation from the State, the Administrator determines that the extension is necessary and justified; (2) has adopted and is implementing adequate procedures for the enforcement of such State regulations, including conducting such monitoring and making such inspections as the Administrator may require by regulation; (3) will keep such records and make such reports with respect to its activities under paragraphs (1) and (2) as the Administrator may require by regulation; (4) if it permits variances or exemptions, or both, from the requirements of its drinking water regulations which meet the requirements of paragraph (1), permits such variances and exemptions under conditions and in a manner which is not less stringent than the conditions under, and the manner in, which variances and exemptions may be granted under Sections 1415 and 1416; (5) has adopted and can implement an adequate plan for the provision of safe drinking water under emergency circumstances, including earthquakes, floods, hurricanes, and other natural disasters, as appropriate; and (6) has adopted authority for administrative penalties (unless the constitution of the State prohibits the adoption of the authority) in a maximum amount (A) in the case of a system serving a population of more than 10,000, that is not less than $1,000 per day per violation; and (B) in the case of any other system, that is adequate to ensure compliance (as determined by the State); except that a State may establish a maximum limitation on the total amount of administrative penalties that may be imposed on a public water system per violation. (b)(1) The Administrator shall, by regulation (proposed within 180 days of the date of the enactment of this title), prescribe the manner in which a State may apply to the Administrator for a determination that the requirements of paragraphs (1), (2), (3), and (4) of subsection (a) are satisfied with respect to the State, the manner in which the determination is made, the period for which the determination will be effective, and the manner in which the Administrator may determine that such requirements are no longer met. Such regulations shall require that before a determination of the Administrator that such requirements are met or are no longer met

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with respect to a State may become effective, the Administrator shall notify such State of the determination and the reasons thereof and shall provide an opportunity for public hearing on the determination. Such regulations shall be promulgated (with such modifications as the Administrator deems appropriate) within 90 days of the publication of the proposed regulations in the Federal Register. The Administrator shall promptly notify in writing the chief executive officer of each State of the promulgation of regulations under this paragraph. Such notice shall contain a copy of the regulations and shall specify a State’s authority under this title when it is determined to have primary enforcement responsibility for public water systems. (2) When an application is submitted in accordance with the Administrator’s regulations under paragraph (1), the Administrator shall within 90 days of the date on which such application is submitted (A) make the determination applied for, or (B) deny the application and notify the applicant in writing of the reasons for his denial. (c) INTERIM PRIMARY ENFORCEMENT AUTHORITY. A State that has primary enforcement authority under this section with respect to each existing national primary drinking water regulation shall be considered to have primary enforcement authority with respect to each new or revised national primary drinking water regulation during the period beginning on the effective date of a regulation adopted and submitted by the State with respect to the new or revised national primary drinking water regulation in accordance with subsection (b)(1) and ending at such time as the Administrator makes a determination under subsection (b)(2)(B) with respect to the regulation.

ENFORCEMENT OF DRINKING WATER REGULATIONS 42 USC 300g-3 SECTION 1414. (a)(1)(A) Whenever the Administrator finds during a period during which a State has primary enforcement responsibility for public water systems [within the meaning of section 1413 (a)] that any public water system (i) for which a variance under Section 1415 or an exemption under section 1416 is not in effect, does not comply with any applicable requirement; or (ii) for which a variance under Section 1415 or an exemption under section 1416 is in effect, does not comply with any schedule or other requirement imposed pursuant thereto, he shall so notify the State and such public water system and provide such advice and technical assistance to such State and public water system as may be appropriate to bring the system into compliance with the requirement by the earliest feasible time. (B) If, beyond the thirtieth day after the Administrator’s notification under subparagraph (A), the State has not commenced appropriate enforcement action, the Administrator shall issue an order under subsection (g) requiring the public water system to comply with such applicable requirement or the Administrator shall commence a civil action under subsection (b).

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(2) ENFORCEMENT IN NONPRIMACY STATES (A) IN GENERAL. If, on the basis of information available to the Administrator, the Administrator finds, with respect to a period in which a State does not have primary enforcement responsibility for public water systems, that a public water system in the State (i) for which a variance under Section 1415 or an exemption under Section 1416 is not in effect, does not comply with any applicable requirement; or (ii) for which a variance under Section 1415 or an exemption under Section 1416 is in effect, does not comply with any schedule or other requirement imposed pursuant to the variance or exemption, the Administrator shall issue an order under subsection (g) requiring the public water system to comply with the requirement, or commence a civil action under subsection (b). (B) NOTICE. If the Administrator takes any action pursuant to this paragraph, the Administrator shall notify an appropriate local elected official, if any, with jurisdiction over the public water system of the action prior to the time that the action is taken. (b) The Administrator may bring a civil action in the appropriate United States district court to require compliance with any applicable requirement with an order issued under subsection (g), or with any schedule or other requirement imposed pursuant to a variance or exemption granted under Section 1415 or 1416 if (1) authorized under paragraph (1) or (2) of subsection (a); or (2) if requested by (A) the chief executive officer of the State in which is located the public water system which is not in compliance with such regulation or requirement, or (B) the agency of such State which has jurisdiction over compliance by public water systems in the State with national primary drinking water regulations or State drinking water regulations. The court may enter, in an action brought under this subsection, such judgment as protection of public health may require, taking into consideration the time necessary to comply and the availability of alternative water supplies; and, if the court determines that there has been a violation of the regulation or schedule or other requirement with respect to which the action was brought, the court may, taking into account the seriousness of the violation, the population at risk, and other appropriate factors, impose on the violator a civil penalty of not to exceed $25,000 for each day in which such violation occurs. (c) NOTICE TO PERSONS SERVED (1) IN GENERAL. Each owner or operator of a public water system shall give notice of each of the following to the persons served by the system (A) Notice of any failure on the part of the public water system to (i) comply with an applicable maximum contaminant level or treatment technique requirement of, or a testing procedure prescribed by, a national primary drinking water regulation; or (ii) perform monitoring required by section 1445(a).

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(B) If the public water system is subject to a variance granted under subsection (a)(1)(A), (a)(2), or (e) of Section 1415 for an inability to meet a maximum contaminant level requirement or is subject to an exemption granted under Section 1416, notice of (i) the existence of the variance or exemption; and (ii) any failure to comply with the requirements of any schedule prescribed pursuant to the variance or exemption. (C) Notice of the concentration level of any unregulated contaminant for which the Administrator has required public notice pursuant to paragraph (2)(E). (2) FORM, MANNER, AND FREQUENCY OF NOTICE (A) IN GENERAL. The Administrator shall, by regulation, and after consultation with the States, prescribe the manner, frequency, form, and content for giving notice under this subsection. The regulations shall (i) provide for different frequencies of notice based on the differences between violations that are intermittent or infrequent and violations that are continuous or frequent; and (ii) take into account the seriousness of any potential adverse health effects that may be involved. (B) STATE REQUIREMENTS (i) IN GENERAL. A State may, by rule, establish alternative notification requirements (I) with respect to the form and content of notice given under and in a manner in accordance with subparagraph (C); and (II) with respect to the form and content of notice given under subparagraph (D). (ii) CONTENTS. The alternative requirements shall provide the same type and amount of information as required pursuant to this subsection and regulations issued under subparagraph (A). (iii) RELATIONSHIP TO SECTION 1413. Nothing in this subparagraph shall be construed or applied to modify the requirements of Section 1413. (C) VIOLATIONS WITH POTENTIAL TO HAVE SERIOUS ADVERSE EFFECTS ON HUMAN HEALTH. Regulations issued under subparagraph (A) shall specify notification procedures for each violation by a public water system that has the potential to have serious adverse effects on human health as a result of short-term exposure. Each notice of violation provided under this subparagraph shall (i) be distributed as soon as practicable after the occurrence of the violation, but not later than 24 hours after the occurrence of the violation; (ii) provide a clear and readily understandable explanation of (I) the violation; (II) the potential adverse effects on human health; (III) the steps that the public water system is taking to correct the violation; and (IV) the necessity of seeking alternative water supplies until the violation is corrected; (iii) be provided to the Administrator or the head of the State agency that has primary enforcement responsibility under section 1413 as soon as practicable, but not later than 24 hours after the occurrence of the violation; and

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(iv) as required by the State agency in general regulations of the State agency, or on a case-by-case basis after the consultation referred to in clause (iii), considering the health risks involved (I) be provided to appropriate broadcast media; (II) be prominently published in a newspaper of general circulation serving the area not later than 1 day after distribution of a notice pursuant to clause (i) or the date of publication of the next issue of the newspaper; or (III) be provided by posting or door-to-door notification in lieu of notification by means of broadcast media or newspaper. (D) WRITTEN NOTICE (i) IN GENERAL. Regulations issued under subparagraph (A) shall specify notification procedures for violations other than the violations covered by subparagraph (C). The procedures shall specify that a public water system shall provide written notice to each person served by the system by notice (I) in the first bill (if any) prepared after the date of occurrence of the violation, (II) in an annual report issued not later than 1 year after the date of occurrence of the violation, or (III) by mail or direct delivery as soon as practicable, but not later than 1 year after the date of occurrence of the violation. (ii) FORM AND MANNER OF NOTICE. The Administrator shall prescribe the form and manner of the notice to provide a clear and readily understandable explanation of the violation, any potential adverse health effects, and the steps that the system is taking to seek alternative water supplies, if any, until the violation is corrected. (E) UNREGULATED CONTAMINANTS. The Administrator may require the owner or operator of a public water system to give notice to the persons served by the system of the concentration levels of an unregulated contaminant required to be monitored under Section 1445(a). (3) REPORTS (A) ANNUAL REPORT BY STATE (i) IN GENERAL. Not later than January 1, 1998, and annually thereafter, each State that has primary enforcement responsibility under Section 1413 shall prepare, make readily available to the public, and submit to the Administrator an annual report on violations of national primary drinking water regulations by public water systems in the State, including violations with respect to (I) maximum contaminant levels, (II) treatment requirements, (III) variances and exemptions, and (IV) monitoring requirements determined to be significant by the Administrator after consultation with the States. (ii) DISTRIBUTION. The State shall publish and distribute summaries of the report and indicate where the full report is available for review. (B) ANNUAL REPORT BY ADMINISTRATOR. Not later than July 1, 1998, and annually thereafter, the Administrator shall prepare and make available to the public an annual report summarizing and evaluating reports submitted by States pursuant to subparagraph (A) and notices submitted by public water systems serving Indian Tribes provided to the Administrator pursuant to subparagraph (C) or (D) of paragraph (2) and making recommendations concerning the resources needed to

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improve compliance with this title. The report shall include information about public water system compliance on Indian reservations and about enforcement activities undertaken and financial assistance provided by the Administrator on Indian reservations, and shall make specific recommendations concerning the resources needed to improve compliance with this title on Indian reservations. (4) CONSUMER CONFIDENCE REPORTS BY COMMUNITY WATER SYSTEMS (A) ANNUAL REPORTS TO CONSUMERS. The Administrator, in consultation with public water systems, environmental groups, public interest groups, risk communication experts, and the States, and other interested parties, shall issue regulations within 24 months after the date of enactment of this paragraph to require each community water system to mail to each customer of the system at least once annually a report on the level of contaminants in the drinking water purveyed by that system (referred to in this paragraph as a ‘‘consumer confidence report’’). Such regulations shall provide a brief and plainly worded definition of the terms ‘‘maximum contaminant level goal,’’ ‘‘maximum contaminant level,’’ ‘‘variances,’’ and ‘‘exemptions’’ and brief Statements in plain language regarding the health concerns that resulted in regulation of each regulated contaminant. The regulations shall also include a brief and plainly worded explanation regarding contaminants that may reasonably be expected to be present in drinking water, including bottled water. The regulations shall also provide for a U.S. Environmental Protection Agency toll-free hotline that consumers can call for more information and explanation. (B) CONTENTS OF REPORT. The consumer confidence reports under this paragraph shall include, but not be limited to, each of the following: (i) Information on the source of the water purveyed. (ii) A brief and plainly worded definition of the terms ‘‘maximum contaminant level goal,’’ ‘‘maximum contaminant level,’’ ‘‘variances,’’ and ‘‘exceptions’’ as provided in the regulations of the Administrator. (iii) If any regulated contaminant is detected in the water purveyed by the public water system, a Statement setting forth (I) the maximum contaminant level goal, (II) the maximum contaminant level, (III) the level of such contaminant in such water system, and (IV) for any regulated contaminant for which there has been a violation of the maximum contaminant level during the year concerned, the brief Statement in plain language regarding the health concerns that resulted in regulation of such contaminant, as provided by the Administrator in regulations under subparagraph (A). (iv) Information on compliance with national primary drinking water regulations, as required by the Administrator, and notice if the system is operating under a variance or exemption and the basis on which the variance or exemption was granted. (v) Information on the levels of unregulated contaminants for which monitoring is required under Section 1445(a)(2) (including levels of cryptosporidium and radon where States determine they may be found). (vi) A Statement that the presence of contaminants in drinking water does not necessarily indicate that the drinking water poses a health risk and that more

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information about contaminants and potential health effects can be obtained by calling the U.S. Environmental Protection Agency hotline. A public water system may include such additional information as it deems appropriate for public education. The Administrator may, for not more than 3 regulated contaminants other than those referred to in subclause (IV) of clause (iii), require a consumer confidence report under this paragraph to include the brief Statement in plain language regarding the health concerns that resulted in regulation of the contaminant or contaminants concerned, as provided by the Administrator in regulations under subparagraph (A). (C) COVERAGE. The Governor of a State may determine not to apply the mailing requirement of subparagraph (A) to a community water system serving fewer than 10,000 persons. Any such system shall (i) inform, in the newspaper notice required by clause (iii) or by other means, its customers that the system will not be mailing the report as required by subparagraph (A); (ii) make the consumer confidence report available upon request to the public; and (iii) publish the report referred to in subparagraph (A) annually in one or more local newspapers serving the area in which customers of the system are located. (D) ALTERNATIVE TO PUBLICATION. For any community water system which, pursuant to subparagraph (C), is not required to meet the mailing requirement of subparagraph (A) and which serves 500 persons or fewer, the community water system may elect not to comply with clause (i) or (iii) of subparagraph (C). If the community water system so elects, the system shall, at a minimum (i) prepare an annual consumer confidence report pursuant to subparagraph (B); and (ii) provide notice at least once per year to each of its customers by mail, by doorto-door delivery, by posting or by other means authorized by the regulations of the Administrator that the consumer confidence report is available upon request. (E) ALTERNATIVE FORM AND CONTENT. A State exercising primary enforcement responsibility may establish, by rule, after notice and public comment, alternative requirements with respect to the form and content of consumer confidence reports under this paragraph. (d) Whenever, on the basis of information available to him, the Administrator finds that within a reasonable time after national secondary drinking water regulations have been promulgated, one or more public water systems in a State do not comply with such secondary regulations, and that such noncompliance appears to result from a failure of such State to take reasonable action to assure that public water systems throughout such State meet such secondary regulations, he shall so notify the State. (e) Nothing in this title shall diminish any authority of a State or political subdivision to adopt or enforce any law or regulation respecting drinking water regulations or public water systems, but no such law or regulation shall relieve any person of any requirement otherwise applicable under this title.

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(f) If the Administrator makes a finding of noncompliance [described in subparagraph (A) or (B) of subsection (a)(1)] with respect to a public water system in a State which has primary enforcement responsibility, the Administrator may, for the purpose of assisting that State in carrying out such responsibility and upon the petition of such State or public water system or persons served by such system, hold, after appropriate notice, public hearings for the purpose of gathering information from technical or other experts, Federal, State, or other public officials, representatives of such public water system, persons served by such system, and other interested persons on (1) the ways in which such system can within the earliest feasible time be brought into compliance with the regulation or requirement with respect to which such finding was made, and (2) the means for the maximum feasible protection of the public health during any period in which such system is not in compliance with a national primary drinking water regulation or requirement applicable to a variance or exemption. On the basis of such hearings the Administrator shall issue recommendations which shall be sent to such State and public water system and shall be made available to the public and communications media. (g)(1) In any case in which the Administrator is authorized to bring a civil action under this section or under Section 1445 with respect to any applicable requirement, the Administrator also may issue an order to require compliance with such applicable requirement. (2) An order issued under this subsection shall not take effect, in the case of a State having primary enforcement responsibility for public water systems in that State, until after the Administrator has provided the State with an opportunity to confer with the Administrator regarding the order. A copy of any order issued under this subsection shall be sent to the appropriate State agency of the State involved if the State has primary enforcement responsibility for public water systems in that State. Any order issued under this subsection shall State with reasonable specificity the nature of the violation. In any case in which an order under this subsection is issued to a corporation, a copy of such order shall be issued to appropriate corporate officers. (3)(A) Any person who violates, or fails or refuses to comply with, an order under this subsection shall be liable to the United States for a civil penalty of not more than $25,000 per day of violation. (B) In a case in which a civil penalty sought by the Administrator under this paragraph does not exceed $5000, the penalty shall be assessed by the Administrator after notice and opportunity for a public hearing (unless the person against whom the penalty is assessed requests a hearing on the record in accordance with Section 554 of Title 5, United States Code). In a case in which a civil penalty sought by the Administrator under this paragraph exceeds $5000, but does not exceed $25,000, the penalty shall be assessed by the Administrator after notice and opportunity for a hearing on the record in accordance with Section 554 of Title 5, United States Code.

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(C) Whenever any civil penalty sought by the Administrator under this subsection for a violation of an applicable requirement exceeds $25,000, the penalty shall be assessed by a civil action brought by the Administrator in the appropriate United States district court (as determined under the provisions of Title 28 of the United States Code). (D) If any person fails to pay an assessment of a civil penalty after it has become a final and unappealable order, or after the appropriate court of appeals has entered final judgment in favor of the Administrator, the Attorney General shall recover the amount for which such person is liable in any appropriate district court of the United States. In any such action, the validity and appropriateness of the final order imposing the civil penalty shall not be subject to review. (h) CONSOLIDATION INCENTIVE (1) IN GENERAL. An owner or operator of a public water system may submit to the State in which the system is located (if the State has primary enforcement responsibility under Section 1413) or to the Administrator (if the State does not have primary enforcement responsibility) a plan (including specific measures and schedules) for (A) the physical consolidation of the system with 1 or more other systems; (B) the consolidation of significant management and administrative functions of the system with 1 or more other systems; or (C) the transfer of ownership of the system that may reasonably be expected to improve drinking water quality. (2) CONSEQUENCES OF APPROVAL. If the State or the Administrator approves a plan pursuant to paragraph (1), no enforcement action shall be taken pursuant to this part with respect to a specific violation identified in the approved plan prior to the date that is the earlier of the date on which consolidation is completed according to the plan or the date that is 2 years after the plan is approved. (i) DEFINITION OF APPLICABLE REQUIREMENT. In this section, the term ‘‘applicable requirement’’ means (1) a requirement of Section 1412, 1414, 1415, 1416, 1417, 1433, 1441, or 1445; (2) a regulation promulgated pursuant to a section referred to in paragraph (1); (3) a schedule or requirement imposed pursuant to a section referred to in paragraph (1); and (4) a requirement of, or permit issued under, an applicable State program for which the Administrator has made a determination that the requirements of Section 1413 have been satisfied, or an applicable State program approved pursuant to this part. VARIANCES 42 USC 300g-4 SECTION 1415. (a) Notwithstanding any other provision of this part, variances from national primary drinking water regulations may be granted as follows:

VARIANCES

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(1)(A) A State which has primary enforcement responsibility for public water systems may grant one or more variances from an applicable national primary drinking water regulation to one or more public water systems within its jurisdiction, which, because of characteristics of the raw water sources which are reasonably available to the systems, cannot meet the requirements respecting the maximum contaminant levels of such drinking water regulation. A variance may be issued to a system on condition that the system install the best technology, treatment techniques, or other means, which the Administrator finds are available (taking costs into consideration) and based upon an evaluation satisfactory to the State that indicates that alternative sources of water are not reasonably available to the system. The Administrator shall propose and promulgate his finding of the best available technology, treatment techniques, or other means available for each contaminant for purposes of this subsection at the time he proposes and promulgates a maximum contaminant level for each such contaminant. The Administrator’s finding of best available technology, treatment techniques, or other means for purposes of this subsection may vary depending on the number of persons served by the system or for other physical conditions related to engineering feasibility and costs of compliance with maximum contaminant levels as considered appropriate by the Administrator. Before a State may grant a variance under this subparagraph, the State must find that the variance will not result in an unreasonable risk to health. If a State grants a public water system a variance under this subparagraph the State shall prescribe at the time the variance is granted, a schedule for (i) compliance (including increments of progress) by the public water system with each contaminant level requirement with respect to which the variance was granted, and (ii) implementation by the public water system of such additional control measures as the State may require for each contaminant, subject to such contaminant level requirement, during the period ending on the date compliance with such requirement is required. Before a schedule prescribed by a State pursuant to this subparagraph may take effect, the State shall provide notice and opportunity for a public hearing on the schedule. A notice given pursuant to the preceding sentence may cover the prescribing of more than one such schedule and hearing held pursuant to such notice shall include each of the schedules covered by the notice. A schedule prescribed pursuant to this subparagraph for a public water system granted a variance shall require compliance by the system with each contaminant level requirement with respect to which the variance was granted as expeditiously as practicable (as the State may reasonably determine). (B) A State that has primary enforcement responsibility for public water systems may grant to one or more public water systems within its jurisdiction one or more variances from any provisions of a national primary drinking water regulation which requires the use of a specified treatment technique with respect to a contaminant if the public water system applying for the variance demonstrates to the satisfaction of the State that such treatment technique is not necessary to protect the health of persons because of the nature of the raw water source of such system. A variance

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granted under this subparagraph shall be conditioned on such monitoring and other requirements as the Administrator may prescribe. (C) Before a variance proposed to be granted by a State under subparagraph (A) or (B) may take effect, such State shall provide notice and opportunity for public hearing on the proposed variance. A notice given pursuant to the preceding sentence may cover the granting of more than one variance and a hearing held pursuant to such notice shall include each of the variances covered by the notice. The State shall promptly notify the Administrator of all variances granted by it. Such notification shall contain the reason for the variance [and in the case of a variance under subparagraph (A), the basis for the finding required by that subparagraph before the granting of the variance] and documentation of the need for the variance. (D) Each public water system’s variance granted by a State under subparagraph (A) shall be conditioned by the State upon compliance by the public water system with the schedule prescribed by the State pursuant to that subparagraph. The requirements of each schedule prescribed by a State pursuant to that subparagraph shall be enforceable by the State under its laws. Any requirements of a schedule on which a variance granted under that subparagraph is conditioned may be enforced under Section 1414 as if such requirement was part of a national primary drinking water regulation. (E) Each schedule prescribed by a State pursuant to subparagraph (A) shall be deemed approved by the Administrator unless the variance for which it was prescribed is revoked by the Administrator under such subparagraph. (F) Not later than 18 months after the effective date of the interim national primary drinking water regulations the Administrator shall complete a comprehensive review of the variances granted under subparagraph (A) (and schedules prescribed pursuant thereto) and under subparagraph (B) by the States during the one-year period beginning on such effective date. The Administrator shall conduct such subsequent review of variances and schedules as he deems necessary to carry out the purposes of this title, but each subsequent review shall be completed within each 3-year period following the completion of the first review under this subparagraph. Before conducting any review under this subparagraph, the Administrator shall publish notice of the proposed review in the Federal Register. Such notice shall (i) provide information respecting the location of data and other information respecting the variances to be reviewed (including data and other information concerning new scientific matters bearing on such variances), and (ii) advise of the opportunity to submit comments on the variances reviewed and on the need for continuing them. Upon completion of any such review, the Administrator shall publish in the Federal Register the results of his review together with findings responsive to comments submitted in connection with such review. (G)(i) If the Administrator finds that a State has, in a substantial number of instances, abused its discretion in granting variances under subparagraph (A) or (B) or that in a substantial number of cases the State has failed to prescribe schedules in accordance with subparagraph (A), the Administrator shall notify the State of his findings. In determining if a State has abused its discretion in granting variances in a substantial number of instances, the Administrator shall consider the number of

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persons who are affected by the variances and if the requirements applicable to the granting of the variances were complied with. A notice under this clause shall (I) identify each public water system with respect to which the finding was made, (II) specify the reasons for the finding, and (III) as appropriate, propose revocations of specific variances or propose revised schedules or other requirements for specific public water systems granted variances, or both. (ii) The Administrator shall provide reasonable notice and public hearing on the provisions of each notice given pursuant to clause (i) of this subparagraph. After a hearing on a notice pursuant to such clause, the Administrator shall (I) rescind the finding for which the notice was given and promptly notify the State of such rescission, or (II) promulgate (with such modifications as he deems appropriate) such variance revocations and revised schedules or other requirements proposed in such notice as he deems appropriate. Not later than 180 days after the date a notice is given pursuant to clause (i) of this subparagraph, the Administrator shall complete the hearing on the notice and take the action required by the preceding sentence. (iii) If a State is notified under clause (i) of this subparagraph of a finding of the Administrator made with respect to a variance granted a public water system within that State or to a schedule or other requirement for a variance and if, before a revocation of such variance or a revision of such schedule or other requirement promulgated by the Administrator take effect, the State takes corrective action with respect to such variance or schedule or other requirement which the Administrator determines makes his finding inapplicable to such variance or schedule or other requirement, the Administrator shall rescind the application of his finding to that variance or schedule or other requirement. No variance revocation or revised schedule or other requirement may take effect before the expiration of 90 days following the date of the notice in which the revocation or revised schedule or other requirement was proposed. (2) If a State does not have primary enforcement responsibility for public water systems, the Administrator shall have the same authority to grant variances in such State as the State would have under paragraph (I) if it had primary enforcement responsibility. (3) The Administrator may grant a variance from any treatment technique requirement of a national primary drinking water regulation upon a showing by any person that an alternative treatment technique not included in such requirement is at least as efficient in lowering the level of the contaminant with respect to which such requirement was prescribed. A variance under this paragraph shall be conditioned on the use of the alternative treatment technique which is the basis of the variance. (b) Any schedule or other requirement on which a variance granted under paragraph (1)(B) or (2) of subsection (a) is conditioned may be enforced under Section 1414 as if such schedule or other requirement was part of a national primary drinking water regulation. (c) If an application for variance under subsection (a) is made, the State receiving the application or the Administrator, as the case may be, shall act upon such

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application within a reasonable period (as determined under regulations prescribed by the Administrator) after the date of its submission. (d) For purposes of this section, the term ‘‘treatment technique requirement’’ means a requirement in a national primary drinking water regulation which specifies for a contaminant (in accordance with Section 1401(1)(C)(ii) each treatment technique known to the Administrator which leads to a reduction in the level of such contaminant sufficient to satisfy the requirements of Section 1412(b). (e) SMALL SYSTEM VARIANCES (1) IN GENERAL. A State exercising primary enforcement responsibility for public water systems under section 1413 (or the Administrator in nonprimacy States) may grant a variance under this subsection for compliance with a requirement specifying a maximum contaminant level or treatment technique contained in a national primary drinking water regulation to (A) public water systems serving 3300 or fewer persons; and (B) with the approval of the Administrator pursuant to paragraph (9), public water systems serving more than 3300 persons but fewer than 10,000 persons, if the variance meets each requirement of this subsection. (2) AVAILABILITY OF VARIANCES. A public water system may receive a variance pursuant to paragraph (1), if (A) the Administrator has identified a variance technology under Section 1412(b)(15) that is applicable to the size and source water quality conditions of the public water system; (B) the public water system installs, operates, and maintains, in accordance with guidance or regulations issued by the Administrator, such treatment technology, treatment technique, or other means; and (C) the State in which the system is located determines that the conditions of paragraph (3) are met. (3) CONDITIONS FOR GRANTING VARIANCES. A variance under this subsection shall be available only to a system (A) that cannot afford to comply, in accordance with affordability criteria established by the Administrator (or the State in the case of a State that has primary enforcement responsibility under Section 1413), with a national primary drinking water regulation, including compliance through (i) treatment; (ii) alternative source of water supply; or (iii) restructuring or consolidation (unless the Administrator (or the State in the case of a State that has primary enforcement responsibility under Section 1413) makes a written determination that restructuring or consolidation is not practicable); and (B) for which the Administrator (or the State in the case of a State that has primary enforcement responsibility under Section 1413) determines that the terms of the variance ensure adequate protection of human health, considering the quality of the source water for the system and the removal efficiencies and expected useful life of the treatment technology required by the variance.

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(4) COMPLIANCE SCHEDULES. A variance granted under this subsection shall require compliance with the conditions of the variance not later than 3 years after the date on which the variance is granted, except that the Administrator (or the State in the case of a State that has primary enforcement responsibility under Section 1413) may allow up to 2 additional years to comply with a variance technology, secure an alternative source of water, restructure or consolidate if the Administrator (or the State) determines that additional time is necessary for capital improvements, or to allow for financial assistance provided pursuant to Section 1452 or any other Federal or State program. (5) DURATION OF VARIANCES. The Administrator (or the State in the case of a State that has primary enforcement responsibility under Section 1413) shall review each variance granted under this subsection not less often than every 5 years after the compliance date established in the variance to determine whether the system remains eligible for the variance and is conforming to each condition of the variance. (6) INELIGIBILITY FOR VARIANCES. A variance shall not be available under this subsection for (A) any maximum contaminant level or treatment technique for a contaminant with respect to which a national primary drinking water regulation was promulgated prior to January 1, 1986; or (B) a national primary drinking water regulation for a microbial contaminant (including a bacterium, virus, or other organism) or an indicator or treatment technique for a microbial contaminant. (7) REGULATIONS AND GUIDANCE (A) IN GENERAL. Not later than 2 years after the date of enactment of this subsection and in consultation with the States, the Administrator shall promulgate regulations for variances to be granted under this subsection. The regulations shall, at a minimum, specify (i) procedures to be used by the Administrator or a State to grant or deny variances, including requirements for notifying the Administrator and consumers of the public water system that a variance is proposed to be granted (including information regarding the contaminant and variance) and requirements for a public hearing on the variance before the variance is granted; (ii) requirements for the installation and proper operation of variance technology that is identified [pursuant to Section 1412(b)(15)] for small systems and the financial and technical capability to operate the treatment system, including operator training and certification; (iii) eligibility criteria for a variance for each national primary drinking water regulation, including requirements for the quality of the source water [pursuant to Section 1412(b)(15)(A)]; (iv) information requirements for variance applications. (B) AFFORDABILITY CRITERIA. Not later than 18 months after the date of enactment of the Safe Drinking Water Act Amendments of 1996, the Administrator, in consultation with the States and the Rural Utilities Service of the Department of Agriculture, shall publish information to assist the States in developing affordability

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criteria. The affordability criteria shall be reviewed by the States not less often than every 5 years to determine if changes are needed to the criteria. (8) REVIEW BY THE ADMINISTRATOR (A) IN GENERAL. The Administrator shall periodically review the program of each State that has primary enforcement responsibility for public water systems under Section 1413 with respect to variances to determine whether the variances granted by the State comply with the requirements of this subsection. With respect to affordability, the determination of the Administrator shall be limited to whether the variances granted by the State comply with the affordability criteria developed by the State. (B) NOTICE AND PUBLICATION. If the Administrator determines that variances granted by a State are not in compliance with affordability criteria developed by the State and the requirements of this subsection, the Administrator shall notify the State in writing of the deficiencies and make public the determination. (9) APPROVAL OF VARIANCES. A State proposing to grant a variance under this subsection to a public water system serving more than 3300 and fewer than 10,000 persons shall submit the variance to the Administrator for review and approval prior to the issuance of the variance. The Administrator shall approve the variance if it meets each of the requirements of this subsection. The Administrator shall approve or disapprove the variance within 90 days. If the Administrator disapproves a variance under this paragraph, the Administrator shall notify the State in writing of the reasons for disapproval and the variance may be resubmitted with modifications to address the objections Stated by the Administrator. (10) OBJECTIONS TO VARIANCES (A) BY THE ADMINISTRATOR. The Administrator may review and object to any variance proposed to be granted by a State, if the objection is communicated to the State not later than 90 days after the State proposes to grant the variance. If the Administrator objects to the granting of a variance, the Administrator shall notify the State in writing of each basis for the objection and propose a modification to the variance to resolve the concerns of the Administrator. The State shall make the recommended modification or respond in writing to each objection. If the State issues the variance without resolving the concerns of the Administrator, the Administrator may overturn the State decision to grant the variance if the Administrator determines that the State decision does not comply with this subsection. (B) PETITION BY CONSUMERS. Not later than 30 days after a State exercising primary enforcement responsibility for public water systems under Section 1413 proposes to grant a variance for a public water system, any person served by the system may petition the Administrator to object to the granting of a variance. The Administrator shall respond to the petition and determine whether to object to the variance under subparagraph (A) not later than 60 days after the receipt of the petition. (C) TIMING. No variance shall be granted by a State until the later of the following:

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(i) 90 days after the State proposes to grant a variance. (ii) If the Administrator objects to the variance, the date on which the State makes the recommended modifications or responds in writing to each objection.

EXEMPTIONS 42 USC 300g-5 SECTION 1416. (a) A State which has primary enforcement responsibility may exempt any public water system within the State’s jurisdiction from any requirement respecting a maximum contaminant level or any treatment technique requirement, or from both, of an applicable national primary drinking water regulation upon a finding that (1) due to compelling factors [which may include economic factors, including qualification of the public water system as a system serving a disadvantage community pursuant to Section 1452(d)], the public water system is unable to comply with such contaminant level or treatment technique requirement or to implement measures to develop an alternative source of water supply; (2) the public water system was in operation on the effective date of such contaminant level or treatment technique requirement or for a system that was not in operation by that date, only if no reasonable alternative source of drinking water is available to such new system; (3) the granting of the exemption will not result in an unreasonable risk to health; and (4) management or restructuring changes (or both) cannot reasonably be made that will result in compliance with this title or, if compliance cannot be achieved, improve the quality of the drinking water. (b)(1) If a State grants a public water system an exemption under subsection (a), the State shall prescribe, at the time the exemption is granted, a schedule for (A) compliance (including increments of progress or measures to develop an alternative source of water supply) by the public water system with each contaminant level requirement or treatment technique requirement with respect to which the exemption was granted, and (B) implementation by the public water system of such control measures as the State may require for each contaminant, subject to such contaminant level requirement or treatment technique requirement, during the period ending on the date compliance with such requirement is required. Before a schedule prescribed by a State pursuant to this subsection may take effect, the State shall provide notice and opportunity for a public hearing on the schedule. A notice given pursuant to the preceding sentence may cover the prescribing of more than one such schedule and a hearing held pursuant to such notice shall include each of the schedules covered by the notice.

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(2)(A) A schedule prescribed pursuant to this subsection for a public water system granted an exemption under subsection (a) shall require compliance by the system with each contaminant level and treatment technique requirement with respect to which the exemption was granted as expeditiously as practicable (as the State may reasonably determine) but not later than 3 years after the otherwise applicable compliance date established in Section 1412(b)(10). (B) No exemption shall be granted unless the public water system establishes that (i) the system cannot meet the standard without capital improvements which cannot be completed prior to the date established pursuant to Section 1412(b)(10); (ii) in the case of a system which needs financial assistance for the necessary improvements, the system has entered into an agreement to obtain such financial assistance or assistance pursuant to Section 1452, or any other Federal or State program is reasonably likely to be available within the period of the exemption; or (iii) the system has entered into an enforceable agreement to become a part of a regional public water system; and the system is taking all practicable steps to meet the standard. (C) In the case of a system which does not serve more than a population of 3300 and which needs financial assistance for the necessary improvements, an exemption granted under clause (i) or (ii) of subparagraph (B) may be renewed for one or more additional 2-year periods, but not to exceed a total of 6 years, if the system establishes that it is taking all practicable steps to meet the requirements of subparagraph (B). (D) LIMITATION. A public water system may not receive an exemption under this Section if the system was granted a variance under section 1415(e). (3) Each public water system’s exemption granted by a State under subsection (a) shall be conditioned by the State on compliance by the public water system with the schedule prescribed by the State pursuant to this subsection. The requirements of each schedule prescribed by a State pursuant to this subsection shall be enforceable by the State under its laws. Any requirement of a schedule on which an exemption granted under this section is conditioned may be enforced under Section 1414 as if such requirement was part of a national primary drinking water regulation. (4) Each schedule prescribed by a State pursuant to this subsection shall be deemed approved by the Administrator unless the exemption for which it was prescribed is revoked by the Administrator under subsection (d)(2) or the schedule is revised by the Administrator under such subsection. (c) Each State which grants an exemption under subsection (a) shall promptly notify the Administrator of the granting of such exemption. Such notification shall contain the reasons for the exemption (including the basis for the finding required by subsection (a)(3) before the exemption may be granted) and document the need for the exemption. (d)(1) Not later than 18 months after the effective date of the interim national primary drinking water regulations the Administrator shall complete a comprehensive review of the exemptions granted (and schedules prescribed pursuant thereto) by the States during the one-year period beginning on such effective date. The Administrator shall conduct such subsequent reviews of exemptions and schedules as he

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deems necessary to carry out the purposes of this title, but each subsequent review shall be completed within each 3-year period following the completion of the first review under this subparagraph. Before conducting any review under this subparagraph, the Administrator shall publish notice of the proposed review in the Federal Register. Such notice shall (A) provide information respecting the location of data and other information respecting the exemptions to be reviewed (including data and other information concerning new scientific matters bearing on such exemptions), and (B) advise of the opportunity to submit comments on the exemptions reviewed and on the need for continuing them. Upon completion of any such review, the Administrator shall publish in the Federal Register the results of his review together with findings responsive to comments submitted in connection with such review. (2)(A) If the Administrator finds that a State has, in a substantial number of instances, abused its discretion in granting exemptions under subsection (a) or failed to prescribe schedules in accordance with subsection (b), the Administrator shall notify the State of his finding. In determining if a State has abused its discretion in granting exemptions in a substantial number of instances, the Administrator shall consider the number of persons who are affected by the exemptions and if the requirements applicable to the granting of the exemptions were complied with. A notice under this paragraph shall (i) identify each exempt public water system with respect to which the finding was made, (ii) specify the reasons for the finding, and (iii) as appropriate, propose revocations of specific exemptions or propose revised schedules for specific exempt public water systems, or both. (B) The Administrator shall provide reasonable notice and public hearing on the provisions of each notice given pursuant to subparagraph (A). After a hearing on a notice pursuant to subparagraph (A), the Administrator shall (i) rescind the finding for which the notice was given and promptly notify the State of such rescission, or (ii) promulgate (with such modifications as he deems appropriate) such exemption revocations and revised schedules proposed in such notice as he deems appropriate. Not later than 180 days after the date a notice is given pursuant to subparagraph (A), the Administrator shall complete the hearing on the notice and take the action required by the preceding sentence. (C) If a State is notified under subparagraph (A) of a finding of the Administrator made with respect to an exemption granted a public water system within that State or to a schedule prescribed pursuant to such an exemption and if before a revocation of such exemption or a revision of such schedule promulgated by the Administrator takes effect, the State takes corrective action with respect to such exemption or schedule that the Administrator determines makes his finding inapplicable to such exemption or schedule, the Administrator shall rescind the application of his finding to that exemption or schedule. No exemption revocation or revised schedule may take effect before the expiration of 90 days following the date of the notice in which the revocation or revised schedule was proposed. (e) For purposes of this section, the term ‘‘treatment technique requirement’’ means a requirement in a national primary drinking water regulation which specifies

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for a contaminant [in accordance with Section 1401(1)(C)(ii)] each treatment technique known to the Administrator which leads to a reduction in the level of such contaminant sufficient to satisfy the requirements of Section 1412(b). (f) If a State does not have primary enforcement responsibility for public water systems, the Administrator shall have the same authority to exempt public water systems in such State from maximum contaminant level requirements and treatment technique requirements under the same conditions and in the same manner as the State would be authorized to grant exemptions under this section if it had primary enforcement responsibility. (g) If an application for an exemption under this section is made, the State receiving the application or the Administrator, as the case may be, shall act upon such application within a reasonable period (as determined under regulations prescribed by the Administrator) after the date of its submission.

PROHIBITION ON USE OF LEAD PIPES, SOLDER, AND FLUX 42 USC 300g-6 SECTION 1417. (a) In general (1) PROHIBITIONS (A) IN GENERAL. No person may use any pipe, any pipe or plumbing fitting or fixture, any solder, or any flux, after June 19, 1986, in the installation or repair of (i) any public water system; or (ii) any plumbing in a residential or nonresidential facility providing water for human consumption, that is not lead free [within the meaning of subsection (d)]. (B) LEADED JOINTS. Subparagraph (A) shall not apply to leaded joints necessary for the repair of cast iron pipes. (2) PUBLIC NOTICE REQUIREMENTS (A) IN GENERAL. Each owner or operator of a public water system shall identify and provide notice to persons that may be affected by lead contamination of their drinking water where such contamination results from either or both of the following: (i) The lead content in the construction materials of the public water distribution system. (ii) Corrosivity of the water supply sufficient to cause leaching of lead. The notice shall be provided in such manner and form as may be reasonably required by the Administrator. Notice under this paragraph shall be provided notwithstanding the absence of a violation of any national drinking water standard. (B) CONTENTS OF NOTICE. Notice under this paragraph shall provide a clear and readily understandable explanation of (i) the potential sources of lead in the drinking water, (ii) potential adverse health effects, (iii) reasonably available methods of mitigating known or potential lead content in drinking water,

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(iv) any steps the system is taking to mitigate lead content in drinking water, and (v) the necessity for seeking alternative water supplies, if any. (3) UNLAWFUL ACTS. Effective 2 years after the date of enactment of this paragraph, it shall be unlawful (A) for any person to introduce into commerce any pipe, or any pipe or plumbing fitting or fixture, that is not lead free, except for a pipe that is used in manufacturing or industrial processing; (B) for any person engaged in the business of selling plumbing supplies, except manufacturers, to sell solder or flux that is not lead free; or (C) for any person to introduce into commerce any solder or flux that is not leadfree unless the solder or flux bears a prominent label stating that it is illegal to use the solder or flux in the installation or repair of any plumbing providing water for human consumption. (b) STATE ENFORCEMENT (1) ENFORCEMENT OF PROHIBITION. The requirements of subsection (a)(1) shall be enforced in all States effective 24 months after the enactment of this section. States shall enforce such requirements through State or local plumbing codes, or such other means of enforcement as the State may determine to be appropriate. (2) ENFORCEMENT OF PUBLIC NOTICE REQUIREMENTS. The requirements of subsection (a)(2) shall apply in all States effective 24 months after the enactment of this section. (c) PENALTIES. If the Administrator determines that a State is not enforcing the requirements of subsection (a) as required pursuant to subsection (b), the Administrator may withhold up to 5 percent of Federal funds available to that State for State program grants under Section 1443(a). (d) DEFINITION OF ‘‘LEAD-FREE.’’ For purposes of this section, the term ‘‘lead-free’’ (1) when used with respect to solders and flux refers to solders and flux containing not more than 0.2 percent lead, (2) when used with respect to pipes and pipe fittings refers to pipes and pipe fittings containing not more than 8.0 percent lead, and (3) when used with respect to plumbing fittings and fixtures, refers to plumbing fittings and fixtures in compliance with standards established in accordance with subsection (e). (e) PLUMBING FITTINGS AND FIXTURES (1) IN GENERAL. The Administrator shall provide accurate and timely technical information and assistance to qualified third-party certifiers in the development of voluntary standards and testing protocols for the leaching of lead from new plumbing fittings and fixtures that are intended by the manufacturer to dispense water for human ingestion. (2) STANDARDS (A) IN GENERAL. If a voluntary standard for the leaching of lead is not established by the date that is 1 year after the date of enactment of this subsection, the Administrator shall, not later than 2 years after the date of enactment of this subsection, promulgate regulations setting a health-effects-based performance standard

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establishing maximum leaching levels from new plumbing fittings and fixtures that are intended by the manufacturer to dispense water for human ingestion. The standard shall become effective on the date that is 5 years after the date of promulgation of the standard. (B) ALTERNATIVE REQUIREMENT. If regulations are required to be promulgated under subparagraph (A) and have not been promulgated by the date that is 5 years after the date of enactment of this subsection, no person may import, manufacture, process, or distribute in commerce a new plumbing fitting or fixture, intended by the manufacturer to dispense water for human ingestion, that contains more than 4 percent lead by dry weight.

MONITORING OF CONTAMINANTS 42 USC 300g-7 SECTION 1418. (a) INTERIM MONITORING RELIEF AUTHORITY (1) IN GENERAL. A State exercising primary enforcement responsibility for public water systems may modify the monitoring requirements for any regulated or unregulated contaminants for which monitoring is required other than microbial contaminants (or indicators thereof), disinfectants, and disinfection byproducts or corrosion byproducts for an interim period to provide that any public water system serving 10,000 persons or fewer shall not be required to conduct additional quarterly monitoring during an interim relief period for such contaminants if (A) monitoring, conducted at the beginning of the period for the contaminant concerned and certified to the State by the public water system, fails to detect the presence of the contaminant in the ground or surface water supplying the public water system; and (B) the State, considering the hydrogeology of the area and other relevant factors, determines in writing that the contaminant is unlikely to be detected by further monitoring during such period. (2) TERMINATION; TIMING OF MONITORING. The interim relief period referred to in paragraph (1) shall terminate when permanent monitoring relief is adopted and approved for such State, or at the end of 36 months after the date of enactment of the Safe Drinking Water Act Amendments of 1996, whichever comes first. In order to serve as a basis for interim relief, the monitoring conducted at the beginning of the period must occur at the time determined by the State to be the time of the public water system’s greatest vulnerability to the contaminant concerned in the relevant ground or surface water, taking into account in the case of pesticides the time of application of the pesticide for the source water area and the travel time for the pesticide to reach such waters and taking into account, in the case of other contaminants, seasonality of precipitation and contaminant travel time. (b) PERMANENT MONITORING RELIEF AUTHORITY (1) IN GENERAL. Each State exercising primary enforcement responsibility for public water systems under this title and having an approved source water assess-

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ment program may adopt, in accordance with guidance published by the Administrator, tailored alternative monitoring requirements for public water systems in such State (as an alternative to the monitoring requirements for chemical contaminants set forth in the applicable national primary drinking water regulations) where the State concludes that (based on data available at the time of adoption concerning susceptibility, use, occurrence, or wellhead protection, or from the State’s drinking water source water assessment program) such alternative monitoring would provide assurance that it complies with the Administrator’s guidelines. The State program must be adequate to assure compliance with, and enforcement of, applicable national primary drinking water regulations. Alternative monitoring shall not apply to regulated microbiological contaminants (or indicators thereof), disinfectants and disinfection byproducts, or corrosion byproducts. The preceding sentence is not intended to limit other authority of the Administrator under other provisions of this title to grant monitoring flexibility. (2) GUIDELINES (A) IN GENERAL. The Administrator shall issue, after notice and comment and at the same time as guidelines are issued for source water assessment under Section 1453, guidelines for States to follow in proposing alternative monitoring requirements under paragraph (1) for chemical contaminants. The Administrator shall publish such guidelines in the Federal Register. The guidelines shall assure that the public health will be protected from drinking water contamination. The guidelines shall require that a State alternative monitoring program apply on a contaminant-by-contaminant basis and that, to be eligible for such alternative monitoring program, a public water system must show the State that the contaminant is not present in the drinking water supply or, if present, it is reliably and consistently below the maximum contaminant level. (B) DEFINITION. For purposes of subparagraph (A), the phrase ‘‘reliably and consistently below the maximum contaminant level’’ means that, although contaminants have been detected in a water supply, the State has sufficient knowledge of the contamination source and extent of contamination to predict that the maximum contaminant level will not be exceeded. In determining that a contaminant is reliably and consistently below the maximum contaminant level, States shall consider the quality and completeness of data, the length of time covered and the volatility or stability of monitoring results during that time, and the proximity of such results to the maximum contaminant level. Wide variations in the analytical results, or analytical results close to the maximum contaminant level, shall not be considered to be reliably and consistently below the maximum contaminant level. (3) EFFECT OF DETECTION OF CONTAMINANTS. The guidelines issued by the Administrator under paragraph (2) shall require that if, after the monitoring program is in effect and operating, a contaminant covered by the alternative monitoring program is detected at levels at or above the maximum contaminant level or is no longer reliably or consistently below the maximum contaminant level, the public water system must either (A) demonstrate that the contamination source has been removed or that other action has been taken to eliminate the contamination problem; or

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(B) test for the detected contaminant pursuant to the applicable national primary drinking water regulation. (4) STATES NOT EXERCISING PRIMARY ENFORCEMENT RESPONSIBILITY. The Governor of any State not exercising primary enforcement responsibility under Section 1413 on the date of enactment of this section may submit to the Administrator a request that the Administrator modify the monitoring requirements established by the Administrator and applicable to public water systems in that State. After consultation with the Governor, the Administrator shall modify the requirements for public water systems in that State if the request of the Governor is in accordance with each of the requirements of this subsection that apply to alternative monitoring requirements established by States that have primary enforcement responsibility. A decision by the Administrator to approve a request under this clause shall be for a period of 3 years and may subsequently be extended for periods of 5 years. (c) TREATMENT AS NPDWR. All monitoring relief granted by a State to a public water system for a regulated contaminant under subsection (a) or (b) shall be treated as part of the national primary drinking water regulation for that contaminant. (d) OTHER MONITORING RELIEF. Nothing in this section shall be construed to affect the authority of the States under applicable national primary drinking water regulations to alter monitoring requirements through waivers or other existing authorities. The Administrator shall periodically review and, as appropriate, revise such authorities. OPERATOR CERTIFICATION 42 USC 300g-8 SECTION 1419. (a) GUIDELINES. Not later than 30 months after the date of enactment of the Safe Drinking Water Act Amendments of 1996 and in cooperation with the States, the Administrator shall publish guidelines in the Federal Register, after notice and opportunity for comment from interested persons, including States and public water systems, specifying minimum standards for certification (and recertification) of the operators of community and nontransient noncommunity public water systems. Such guidelines shall take into account existing State programs, the complexity of the system, and other factors aimed at providing an effective program at reasonable cost to States and public water systems, taking into account the size of the system. (b) STATE PROGRAMS. Beginning 2 years after the date on which the Administrator publishes guidelines under subsection (a), the Administrator shall withhold 20 percent of the funds a State is otherwise entitled to receive under Section 1452 unless the State has adopted and is implementing a program for the certification of operators of community and nontransient noncommunity public water systems that meets the requirements of the guidelines published pursuant to subsection (a) or that has been submitted in compliance with subsection (c) and that has not been disapproved.

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(c) EXISTING PROGRAMS. For any State exercising primary enforcement responsibility for public water systems or any other State which has an operator certification program, the guidelines under subsection (a) shall allow the State to enforce such program in lieu of the guidelines under subsection (a) if the State submits the program to the Administrator within 18 months after the publication of the guidelines unless the Administrator determines (within 9 months after the State submits the program to the Administrator) that such program is not substantially equivalent to such guidelines. In making this determination, an existing State program shall be presumed to be substantially equivalent to the guidelines, notwithstanding program differences, based on the size of systems or the quality of source water, providing the State program meets the overall public health objectives of the guidelines. If disapproved, the program may be resubmitted within 6 months after receipt of notice of disapproval. (d) EXPENSE REIMBURSEMENT (1) IN GENERAL. The Administrator shall provide reimbursement for the costs of training, including an appropriate per diem for unsalaried operators, and certification for persons operating systems serving 3300 persons or fewer that are required to undergo training pursuant to this section. (2) STATE GRANTS. The reimbursement shall be provided through grants to States with each State receiving an amount sufficient to cover the reasonable costs for training all such operators in the State, as determined by the Administrator, to the extent required by this section. Grants received by a State pursuant to this paragraph shall first be used to provide reimbursement for training and certification costs of persons operating systems serving 3300 persons or fewer. If a State has reimbursed all such costs, the State may, after notice to the Administrator, use any remaining funds from the grant for any of the other purposes authorized for grants under Section 1452. (3) AUTHORIZATION. There are authorized to be appropriated to the Administrator to provide grants for reimbursement under this section $30,000,000 for each of fiscal years 1997 through 2003. (4) RESERVATION. If the appropriation made pursuant to paragraph (3) for any fiscal year is not sufficient to satisfy the requirements of paragraph (1), the Administrator shall, prior to any other allocation or reservation, reserve such sums as necessary from the funds appropriated pursuant to Section 1452(m) to provide reimbursement for the training and certification costs mandated by this subsection.

CAPACITY DEVELOPMENT 42 USC 300g-9 SECTION 1420. (a) STATE AUTHORITY FOR NEW SYSTEMS. A State shall receive only 80 percent of the allotment that the State is otherwise entitled to receive under Section 1452 (relating to State loan funds) unless the State has obtained the legal authority or other means to ensure that all new community water systems and

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new nontransient, noncommunity water systems commencing operation after October 1, 1999, demonstrate technical, managerial, and financial capacity with respect to each national primary drinking water regulation in effect, or likely to be in effect, on the date of commencement of operations. (b) SYSTEMS IN SIGNIFICANT NONCOMPLIANCE (1) LIST. Beginning not later than 1 year after the date of enactment of this section, each State shall prepare, periodically update, and submit to the Administrator a list of community water systems and nontransient, noncommunity water systems that have a history of significant noncompliance with this title (as defined in guidelines issued prior to the date of enactment of this section or any revisions of the guidelines that have been made in consultation with the States) and, to the extent practicable, the reasons for noncompliance. (2) REPORT. Not later than 5 years after the date of enactment of this section and as part of the capacity development strategy of the State, each State shall report to the Administrator on the success of enforcement mechanisms and initial capacity development efforts in assisting the public water systems listed under paragraph (1) to improve technical, managerial, and financial capacity. (3) WITHHOLDING. The list and report under this subsection shall be considered part of the capacity development strategy of the State required under subsection (c) of this section for purposes of the withholding requirements of Section 1452(a)(1)(G)(i) (relating to State loan funds). (c) CAPACITY DEVELOPMENT STRATEGY (1) IN GENERAL. Beginning 4 years after the date of enactment of this section, a State shall receive only (A) 90 percent in fiscal year 2001; (B) 85 percent in fiscal year 2002; and (C) 80 percent in each subsequent fiscal year, of the allotment that the State is otherwise entitled to receive under Section 1452 (relating to State loan funds), unless the State is developing and implementing a strategy to assist public water systems in acquiring and maintaining technical, managerial, and financial capacity. (2) CONTENT. In preparing the capacity development strategy, the State shall consider, solicit public comment on, and include as appropriate (A) the methods or criteria that the State will use to identify and prioritize the public water systems most in need of improving technical, managerial, and financial capacity; (B) a description of the institutional, regulatory, financial, tax, or legal factors at the Federal, State, or local level that encourage or impair capacity development; (C) a description of how the State will use the authorities and resources of this title or other means to (i) assist public water systems in complying with national primary drinking water regulations; (ii) encourage the development of partnerships between public water systems to enhance the technical, managerial, and financial capacity of the systems; and (iii) assist public water systems in the training and certification of operators;

CAPACITY DEVELOPMENT

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(D) a description of how the State will establish a baseline and measure improvements in capacity with respect to national primary drinking water regulations and State drinking water law; and (E) an identification of the persons that have an interest in and are involved in the development and implementation of the capacity development strategy (including all appropriate agencies of Federal, State, and local governments, private and nonprofit public water systems, and public water system customers). (3) REPORT. Not later than 2 years after the date on which a State first adopts a capacity development strategy under this subsection, and every 3 years thereafter, the head of the State agency that has primary responsibility to carry out this title in the State shall submit to the Governor a report that shall also be available to the public on the efficacy of the strategy and progress made toward improving the technical, managerial, and financial capacity of public water systems in the State. (4) REVIEW. The decisions of the State under this section regarding any particular public water system are not subject to review by the Administrator and may not serve as the basis for withholding funds under Section 1452. (d) FEDERAL ASSISTANCE (1) IN GENERAL. The Administrator shall support the States in developing capacity development strategies. (2) INFORMATIONAL ASSISTANCE (A) IN GENERAL. Not later than 180 days after the date of enactment of this section, the Administrator shall (i) conduct a review of State capacity development efforts in existence on the date of enactment of this section and publish information to assist States and public water systems in capacity development efforts; and (ii) initiate a partnership with States, public water systems, and the public to develop information for States on recommended operator certification requirements. (B) PUBLICATION OF INFORMATION. The Administrator shall publish the information developed through the partnership under subparagraph (A)(ii) not later than 18 months after the date of enactment of this section. (3) PROMULGATION OF DRINKING WATER REGULATIONS. In promulgating a national primary drinking water regulation, the Administrator shall include an analysis of the likely effect of compliance with the regulation on the technical, financial, and managerial capacity of public water systems. (4) GUIDANCE FOR NEW SYSTEMS. Not later than 2 years after the date of enactment of this section, the Administrator shall publish guidance developed in consultation with the States describing legal authorities and other means to ensure that all new community water systems and new nontransient, noncommunity water systems demonstrate technical, managerial, and financial capacity with respect to national primary drinking water regulations. (e) VARIANCES AND EXEMPTIONS. Based on information obtained under subsection (c)(3), the Administrator shall, as appropriate, modify regulations concerning variances and exemptions for small public water systems to ensure flexibility in the use of the variances and exemptions. Nothing in this subsection

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shall be interpreted, construed, or applied to affect or alter the requirements of Section 1415 or 1416. (f) SMALL PUBLIC WATER SYSTEMS TECHNOLOGY ASSISTANCE CENTERS (1) GRANT PROGRAM. The Administrator is authorized to make grants to institutions of higher learning to establish and operate small public water system technology assistance centers in the United States. (2) RESPONSIBILITIES OF THE CENTERS. The responsibilities of the small public water system technology assistance centers established under this subsection shall include the conduct of training and technical assistance relating to the information, performance, and technical needs of small public water systems or public water systems that serve Indian Tribes. (3) APPLICATIONS. Any institution of higher learning interested in receiving a grant under this subsection shall submit to the Administrator an application in such form and containing such information as the Administrator may require by regulation. (4) SELECTION CRITERIA. The Administrator shall select recipients of grants under this subsection on the basis of the following criteria: (A) The small public water system technology assistance center shall be located in a State that is representative of the needs of the region in which the State is located for addressing the drinking water needs of small and rural communities or Indian Tribes. (B) The grant recipient shall be located in a region that has experienced problems, or may reasonably be foreseen to experience problems, with small and rural public water systems. (C) The grant recipient shall have access to expertise in small public water system technology management. (D) The grant recipient shall have the capability to disseminate the results of small public water system technology and training programs. (E) The projects that the grant recipient proposes to carry out under the grant are necessary and appropriate. (F) The grant recipient has regional support beyond the host institution. (5) CONSORTIA OF STATES. At least 2 of the grants under this subsection shall be made to consortia of States with low population densities. (6) AUTHORIZATION OF APPROPRIATIONS. There are authorized to be appropriated to make grants under this subsection $2,000,000 for each of the fiscal years 1997 through 1999, and $5,000,000 for each of the fiscal years 2000 through 2003. (g) ENVIRONMENTAL FINANCE CENTERS (1) IN GENERAL. The Administrator shall provide initial funding for one or more university-based environmental finance centers for activities that provide technical assistance to State and local officials in developing the capacity of public water systems. Any such funds shall be used only for activities that are directly related to this title.

REGULATIONS FOR STATE PROGRAMS

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(2) NATIONAL CAPACITY DEVELOPMENT CLEARINGHOUSE. The Administrator shall establish a national public water system capacity development clearinghouse to receive and disseminate information with respect to developing, improving, and maintaining financial and managerial capacity at public water systems. The Administrator shall ensure that the clearinghouse does not duplicate other Federally supported clearinghouse activities. (3) CAPACITY DEVELOPMENT TECHNIQUES. The Administrator may request an environmental finance center funded under paragraph (1) to develop and test managerial, financial, and institutional techniques for capacity development. The techniques may include capacity assessment methodologies, manual and computer based public water system rate models and capital planning models, public water system consolidation procedures, and regionalization models. (4) AUTHORIZATION OF APPROPRIATIONS. There are authorized to be appropriated to carry out this subsection $1,500,000 for each of the fiscal years 1997 through 2003. (5) LIMITATION. No portion of any funds made available under this subsection may be used for lobbying expenses.

Part C—Protection of Underground Sources of Drinking Water REGULATIONS FOR STATE PROGRAMS 42 USC 300h SECTION 1421. (a)(1) The Administrator shall publish proposed regulations for State underground injection control programs within 180 days after the date of enactment of this title. Within 180 days after publication of such proposed regulations, he shall promulgate such regulations with such modifications as he deems appropriate. Any regulation under this subsection may be amended from time to time. (2) Any regulation under this section shall be proposed and promulgated in accordance with Section 553 of Title 5, United States Code (relating to rulemaking), except that the Administrator shall provide opportunity for public hearing prior to promulgation of such regulations. In proposing and promulgating regulations under this section, the Administrator shall consult with the Secretary, the National Drinking Water Advisory Council, and other appropriate Federal entities and with interested State entities. (b)(1) Regulations under subsection (a) for State underground injection programs shall contain minimum requirements for effective programs to prevent underground injection which endangers drinking water sources within the meaning of subsection (d)(2). Such regulations shall require that a State program, in order to be approved under Section 1422

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(A) shall prohibit, effective on the date on which the applicable underground injection control program takes effect, any underground injection in such State which is not authorized by a permit issued by the State (except that the regulations may permit a State to authorize underground injection by rule); (B) shall require (i) in the case of a program which provides for authorization of underground injection by permit, that the applicant for the permit to inject must satisfy the State that the underground injection will not endanger drinking water sources, and (ii) in the case of a program which provides for such an authorization by rule, that no rule may be promulgated which authorizes any underground injection which endangers drinking water sources; (C) shall include inspection, monitoring, recordkeeping, and reporting requirements; and (D) shall apply (i) as prescribed by Section 1447(b), to underground injections by Federal agencies, and (ii) to underground injections by any other person whether or not occurring on property owned or leased by the United States. (2) Regulations of the Administrator under this section for State underground injection control programs may not prescribe requirements which interfere with or impede (A) the underground injection of brine or other fluids which are brought to the surface in connection with oil or natural gas production or natural gas storage, or (B) any underground in injection for the secondary or tertiary recovery of oil or natural gas, unless such requirements are essential to assure that underground sources of drinking water will not be endangered by such injection. (3)(A) The regulations of the Administrator under this section shall permit or provide for consideration of varying geologic, hydrological, or historical conditions in different States and in different areas within a State. (B)(i) In prescribing regulations under this section, the Administrator shall, to the extent feasible, avoid promulgation of requirements which would unnecessarily disrupt State underground injection control programs which are in effect and being enforced in a substantial number of States. (ii) For the purpose of this subparagraph, a regulation prescribed by the Administrator under this section shall be deemed to disrupt a State underground injection control program only if it would be infeasible to comply with both such regulation and the State underground injection control program. (iii) For the purpose of this subparagraph, a regulation prescribed by the Administrator under this section shall be deemed unnecessary only if, without such regulation, underground sources of drinking water will not be endangered by any underground injection. (C) Nothing in this section shall be construed to alter or affect the duty to assure that underground sources of drinking water will not be endangered by any underground injection. (c)(1) The Administrator may, on application of the Governor of a State which authorizes underground injection by means of permits, authorize such State to issue [without regard to subsection (b)(1)(B)(i)] temporary permits for underground injection that may be effective until the expiration of four years after the date of enactment of this title, if

STATE PRIMARY ENFORCEMENT RESPONSIBILITY

785

(A) the Administrator finds that the State has demonstrated that it is unable and could not reasonably have been able to process all permit applications within the time available; (B) the Administrator determines the adverse effect on the environment of such temporary permits is not unwarranted; (C) such temporary permits will be issued only with respect to injection wells in operation on the date on which such State’s permit program approved under this part first takes effect and for which there was inadequate time to process its permit application; and (D) the Administrator determines the temporary permits require the use of adequate safeguards established by rules adopted by him (2) The Administrator may, upon application of the Governor of a State which authorizes underground injection by means of permits, authorize such State to issue [without regard to subsection (b)(1)(B)(i)], but after reasonable notice and hearing, one or more temporary permits, each of which is applicable to a particular injection well and to the underground injection of a particular fluid and which may be effective until the expiration of four years after the date of enactment of this title, if the State finds, on the record of such hearing (A) that technology (or other means) to permit safe injection of the fluid in accordance with the applicable underground injection control program is not generally available (taking costs into consideration) (B) that injection of the fluid would be less harmful to health than the use of other available means of disposing of waste or producing the desired product; and (C) that available technology or other means have been employed (and will be employed) to reduce the volume and toxicity of the fluid and to minimize the potentially adverse effect of the injection on the public health. (d) For purposes of this part (1) The term ‘‘underground injection’’ means the subsurface emplacement of fluids by well injection. Such term does not include the underground injection of natural gas for purposes of storage. (2) Underground injection endangers drinking water sources if such injection may result in the presence in underground water which supplies or can reasonably be expected to supply any public water system of any contaminant, and if the presence of such contaminant may result in such system’s not complying with any national primary drinking water regulation or may otherwise adversely affect the health of persons. STATE PRIMARY ENFORCEMENT RESPONSIBILITY 42 USC 300h-1 SECTION 1422. (a) Within 180 days after the date of enactment of this title, the Administrator shall list in the Federal Register each State for which in his judgment a State underground injection control program may be necessary to assure that underground injection will not endanger drinking water sources. Such list may be amended from time to time.

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(b)(1)(A) Each State listed under subsection (a) shall within 270 days after the date of promulgation of any regulation under Section 1421 [or, if later, within 270 days after such State is first listed under subsection (a)] submit to the Administrator an application which contains a showing satisfactory to the Administrator that the State (i) has adopted after reasonable notice and public hearings, and will implement, an underground injection control program which meets the requirements of regulations in effect under section 1421; and (ii) will keep such records and make such reports with respect to its activities under its underground injection control program as the Administrator may require by regulation. The Administrator may, for good cause, extend the date for submission of an application by any State under this subparagraph for a period not to exceed an additional 270 days. (B) Within 270 days of any amendment of a regulation under Section 1421 revising or adding any requirement respecting State underground injection control programs, each State listed under subsection (a) shall submit (in such form and manner as the Administrator may require) a notice to the Administrator containing a showing satisfactory to him that the State underground injection control program meets the revised or added requirement. (2) Within ninety days after the State’s application under paragraph (1)(A) or notice under paragraph (1)(B) and after reasonable opportunity for presentation of views, the Administrator shall by rule either approve, disapprove, or approve in part and disapprove in part, the State’s underground injection control program. (3) If the Administrator approves the State’s program under paragraph (2), the State shall have primary enforcement responsibility for underground water sources until such time as the Administrator determines, by rule, that such State no longer meets the requirements of clause (i) or (ii) of paragraph (1)(A) of this subsection. (4) Before promulgating any rule under paragraph (2) or (3) of this subsection, the Administrator shall provide opportunity for public hearing respecting such rule. (c) If the Administrator disapproves a State’s program (or part thereof) under subsection (b)(2), if the Administrator determines under subsection (b)(3) that a State no longer meets the requirements of clause (i) or (ii) of subsection (b)(1)(A), or if a State fails to submit an application or notice before the date of expiration of the period specified in subsection (b)(1), the Administrator shall by regulation within 90 days after the date of such disapproval, determination, or expiration (as the case may be) prescribe (and may from time to time by regulation revise) a program applicable to such State meeting the requirements of Section 1421(b). Such program may not include requirements which interfere with or impede (1) the underground injection of brine or other fluids which are brought to the surface in connection with oil or natural gas production or natural gas storage operations, or (2) any underground injection for the secondary or tertiary recovery of oil or natural gas, unless such requirements are essential to assure that underground sources of drinking water will not be endangered by such injection. Such program shall apply in such State to the extent that a program adopted by such State which the

ENFORCEMENT OF PROGRAM

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Administrator determines meet such requirements is not in effect. Before promulgating any regulation under this section, the Administrator shall provide opportunity for public hearing respecting such regulation. (d) For purposes of this title, the term ‘‘applicable underground injection control program’’ with respect to a State means the program (or most recent amendment thereof) (1) which has been adopted by the State and that has been approved under subsection (b), or (2) which has been prescribed by the Administrator under subsection (c). (e) An Indian Tribe may assume primary enforcement responsibility for underground injection control under this section consistent with such regulations as the Administrator has prescribed pursuant to Part C and Section 1451 of this Act. The area over which such Indian Tribe exercises governmental jurisdiction need not have been listed under subsection (a) of this section, and such Tribe need not submit an application to assume primary enforcement responsibility within the 270-day deadline noted in subsection (b)(1)(A) of this section. Until an Indian Tribe assumes primary enforcement responsibility, the currently applicable underground injection control program shall continue to apply. If an applicable underground injection control program does not exist for an Indian Tribe, the Administrator shall prescribe such a program pursuant to subsection (c) of this section, and consistent with Section 1412(b), within 270 days after the enactment of the Safe Drinking Water Act Amendments of 1986, unless an Indian Tribe first obtains approval to assume primary enforcement responsibility for underground injection control. ENFORCEMENT OF PROGRAM 42 USC h-2 SECTION 1423. (a)(1) Whenever the Administrator finds during a period during which a State has primary enforcement responsibility for underground water sources [within the meaning of Section 1422(b)(3)] or Section 1425(c) that any person who is subject to a requirement of an applicable underground injection control program in such State is violating such requirement, he shall so notify the State and the person violating such requirement. If beyond the thirtieth day after the Administrator’s notification the State has not commenced appropriate enforcement action, the Administrator shall issue an order under subsection (c) requiring the person to comply with such requirement or the Administrator shall commence a civil action under subsection (b). (2) Whenever the Administrator finds during a period during which a State does not have primary enforcement responsibility for underground water sources that any person subject to any requirement of any applicable underground injection control program in such States is violating such requirement, the Administrator shall issue an order under subsection (c) requiring the person to comply with such requirement or the Administrator shall commence a civil action under subsection (b). (b) CIVIL AND CRIMINAL ACTIONS. Civil actions referred to in paragraphs (1) and (2) of subsection (a) shall be brought in the appropriate United States district

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court. Such court shall have jurisdiction to require compliance with any requirement of an applicable underground injection program or with an order issued under subsection (c). The court may enter such judgment as protection of public health may require. Any person who violates any requirement of an applicable underground injection control program or an order requiring compliance under subsection (c) (1) shall be subject to a civil penalty of not more than $25,000 for each day of such violation, and (2) if such violation is willful, such person may, in addition to or in lieu of the civil penalty authorized by paragraph (1), be imprisoned for not more than 3 years, or fined in accordance with title 18 of the United States Code, or both. (c) ADMINISTRATIVE ORDERS. (1) In any case in which the Administrator is authorized to bring a civil action under this section with respect to any regulation or other requirement of this part other than those relating to (A) the underground injection of brine or other fluids which are brought to the surface in connection with oil or natural gas production, or (B) any underground injection for the secondary or tertiary recovery of oil or natural gas, the Administrator may also issue an order under this subsection either assessing a civil penalty of not more than $10,000 for each day of violation for any past or current violation, up to a maximum administrative penalty of $125,000, or requiring compliance with such regulation or other requirement, or both. (2) In any case in which the Administrator is authorized to bring a civil action under this section with respect to any regulation, or other requirement of this part relating to (A) the underground injection of brine or other fluids which are brought to the surface in connection with oil or natural gas production, or (B) any underground injection for the secondary or tertiary recovery of oil or natural gas, the Administrator may also issue an order under this subsection either assessing a civil penalty of not more than $5000 for each day of violation for any past or current violation, up to a maximum administrative penalty of $125,000, or requiring compliance with such regulation or other requirement, or both. (3)(A) An order under this subsection shall be issued by the Administrator after opportunity (provided in accordance with this subparagraph) for a hearing. Before issuing the order, the Administrator shall give to the person to whom it is directed written notice of the Administrator’s proposal to issue such order and the opportunity to request, within 30 days of the date the notice is received by such person, a hearing on the order. Such hearing shall not be subject to Section 554 or 556 of Title 5, United States Code, but shall provide a reasonable opportunity to be heard and to present evidence. (B) The Administrator shall provide public notice of, and reasonable opportunity to comment on, any proposed order. (C) Any citizen who comments on any proposed order under subparagraph (B) shall be given notice of any hearing under this subsection and of any order. In any hearing held under subparagraph (A), such citizen shall have a reasonable opportunity to be heard and to present evidence. (D) Any order issued under this subsection shall become effective 30 days following its issuance unless an appeal is taken pursuant to paragraph (6).

ENFORCEMENT OF PROGRAM

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(4)(A) Any order issued under this subsection shall State with reasonable specificity the nature of the violation and may specify a reasonable time for compliance. (B) In assessing any civil penalty under this subsection, the Administrator shall take into account appropriate factors, including (i) the seriousness of the violation; (ii) the economic benefit (if any) resulting from the violation; (iii) any history of such violations; (iv) any good-faith efforts to comply with the applicable requirements; (v) the economic impact of the penalty on the violator; and (vi) such other matters as justice may require. (5) Any violation with respect to which the Administrator has commenced and is diligently prosecuting an action, or has issued an order under this subsection assessing a penalty, shall not be subject to an action under subsection (b) of this section or Section 1424(c) or 1449, except that the foregoing limitation on civil actions under Section 1449 of this Act shall not apply with respect to any violation for which (A) a civil action under Section 1449(a)(1) has been filed prior to commencement of an action under this subsection, or (B) a notice of violation under Section 1449(b)(1) has been given before commencement of an action under this subsection and an action under Section 1449(a)(1) of this Act is filed before 120 days after such notice is given. (6) Any person against whom an order is issued or who commented on a proposed order pursuant to paragraph (3) may file an appeal of such order with the United States District Court for the District of Columbia or the district in which the violation is alleged to have occurred. Such an appeal may only be filed within the 30-day period beginning on the date the order is issued. Appellant shall simultaneously send a copy of the appeal by certified mail to the Administrator and to the Attorney General. The Administrator shall promptly file in such court a certified copy of the record on which such order was imposed. The district court shall not set aside or remand such order unless there is not substantial evidence on the record, taken as a whole, to support the finding of a violation or, unless the Administrator’s assessment of penalty or requirement for compliance constitutes an abuse of discretion. The district court shall not impose additional civil penalties for the same violation unless the Administrator’s assessment of a penalty constitutes an abuse of discretion. Notwithstanding Section 1448(a)(2), any order issued under paragraph (3) shall be subject to judicial review exclusively under this paragraph. (7) If any person fails to pay an assessment of a civil penalty (A) after the order becomes effective under paragraph (3), or (B) after a court, in an action brought under paragraph (6), has entered a final judgment in favor of the Administrator, the Administrator may request the Attorney General to bring a civil action in an appropriate district court to recover the amount assessed (plus costs, attorneys’ fees, and interest at currently prevailing rates from the date the order is effective or the date of such final judgment, as the case may be). In such an action, the validity, amount, and appropriateness of such penalty shall not be subject to review. (8) The Administrator may, in connection with administrative proceedings under this subsection, issue subpoenas compelling the attendance and testimony of witnesses and subpoenas duces tecum, and may request the Attorney General to

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TEXT OF THE SDWA AS AMENDED

bring an action to enforce any subpoena under this section. The district courts shall have jurisdiction to enforce such subpoenas and impose sanction. (d) Nothing in this title shall diminish any authority of a State or political subdivision to adopt or enforce any law or regulation respecting underground injection but no such law or regulation shall relieve any person of any requirement otherwise applicable under this title.

INTERIM REGULATION OF UNDERGROUND INJECTION 42 USC 300h-3 SECTION 1424. (a)(1) Any person may petition the Administrator to have an area of a State (or States) designated as an area in which no new underground injection well may be operated during the period beginning on the date of the designation and ending on the date on which the applicable underground injection control program covering such area takes effect unless a permit for the operation of such well has been issued by the Administrator under subsection (b). The Administrator may so designate an area within a State if he finds that the area has one aquifer which is the sole or principal drinking water source for the area and which, if contaminated, would create a significant hazard to public health. (2) Upon receipt of a petition under paragraph (1) of this subsection, the Administrator shall publish it in the Federal Register and shall provide an opportunity to interested persons to submit written data, views, or arguments thereon. Not later than the 30th day following the date of the publication of a petition under this paragraph in the Federal Register, the Administrator shall either make the designation for which the petition is submitted or deny the petition. (b)(1) During the period beginning on the date an area is designated under subsection (a) and ending on the date the applicable underground injection control program covering such area takes effect, no new underground injection well may be operated in such area unless the Administrator has issued a permit for such operation. (2) Any person may petition the Administrator for the issuance of a permit for the operation of such a well in such an area. A petition submitted under this paragraph shall be submitted in such manner and contain such information as the Administrator may require by regulation. Upon receipt of such a petition, the Administrator shall publish it in the Federal Register. The Administrator shall give notice of any proceeding on a petition and shall provide opportunity for agency hearing. The Administrator shall act upon such petition on the record of any hearing held pursuant to the preceding sentence respecting such petition. Within 120 days of the publication in the Federal Register of a petition submitted under this paragraph, the Administrator shall either issue the permit for which the petition was submitted or shall deny its issuance. (3) The Administrator may issue a permit for the operation of a new underground injection well in an area designated under subsection (a) only if he finds that the

OPTIONAL DEMONSTRATION BY STATES RELATING TO OIL OR NATURAL GAS

791

operation of such well will not cause contamination of the aquifer of such area so as to create a significant hazard to public health. The Administrator may condition the issuance of such a permit upon the use of such control measures in connection with the operation of such well, for which the permit is to be issued, as he deems necessary to assure that the operation of the well will not contaminate the aquifer of the designated area in which the well is located so as to create a significant hazard to public health. (c) Any person who operates a new underground injection well in violation of subsection (b), (1) shall be subject to a civil penalty of not more than $5000 for each day in which such violation occurs, or (2) if such violation is willful, such person may, in lieu of the civil penalty authorized by clause (1) be fined not more than $10,000 for each day in which such violation occurs. If the Administrator has reason to believe that any person is violating or will violate subsection (b), he may petition the United States district court to issue a temporary restraining order or injunction (including a mandatory injunction) to enforce such subsection. (d) For purposes of this section, the term ‘‘new underground injection well’’ means an underground injection well whose operation was not approved by appropriate State and Federal agencies before the date of the enactment of this title. (e) If the Administrator determines, on his own initiative or upon petition, that an area has an aquifer which is the sole or principal drinking water source for the area and which, if contaminated, would create a significant hazard to public health, he shall publish notice of that determination in the Federal Register. After the publication of any such notice, no commitment for Federal financial assistance (through a grant, contract, loan guarantee, or otherwise) may be entered into for any project which the Administrator determines may contaminate such aquifer through a recharge zone so as to create a significant hazard to public health, but a commitment for Federal financial assistance may, if authorized under another provision of law, be entered into a plan or design the project to assure that it will not so contaminate the aquifer.

OPTIONAL DEMONSTRATION BY STATES RELATING TO OIL OR NATURAL GAS 42 USC h-4 SECTION 1425. (a) For purposes of the Administrator’s approval or disapproval under Section 1422 of that portion of any State underground injection control program which relates to (1) the underground injection of brine or other fluids which are brought to the surface in connection with oil or natural gas production or natural gas storage operation, or (2) any underground injection for the secondary or tertiary recovery of oil or natural gas. In lieu of the showing required under subparagraph (A) of Section 1422(b)(1) the State may demonstrate that such portion of the State program

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meets the requirements of subparagraphs (A) through (D) of Section 1421(b)(1) and represents an effective program (including adequate recordkeeping and reporting) to prevent underground injection which endangers drinking water sources. (b) If the Administrator revises or amends any requirement of a regulation under Section 1421 relating to any aspect of the underground injection referred to in subsection (a), in the case of that portion of a State underground injection control program for which the demonstration referred to in subsection (a) has been made, in lieu of the showing required under section 1422(b)(1)(B) the State may demonstrate that, with respect to that aspect of such underground injection, the State program meets the requirements of subparagraphs (A) through (D) of Section 1421(b)(1) and represents an effective program (including adequate recordkeeping and reporting) to prevent underground injection which endangers drinking water sources. (c) (1) Section 1422(b)(3) shall not apply to that portion of any State underground injection control program approved by the Administrator pursuant to a demonstration under subsection (a) of this section (and under subsection (b) of this section where applicable). (2) If pursuant to such a demonstration, the Administrator approves such portion of the State program, the State shall have primary enforcement responsibility with respect to that portion until such time as the Administrator determines, by rule, that such demonstration is no longer valid. Following such a determination, the Administrator may exercise the authority of subsection (c) of Section 1422 in the same manner as provided in such subsection with respect to a determination described in such subsections. (3) Before promulgating any rule under paragraph (2), the Administrator shall provide opportunity for public hearing respecting such rule.

REGULATION OF STATE PROGRAMS 42 USC 300h-5 SECTION 1426. (a) MONITORING METHODS. Not later than 18 months after enactment of the Safe Drinking Water Act Amendments of 1986, the Administrator shall modify regulations issued under this Act for Class I injection wells to identify monitoring methods, in addition to those in effect on November 1, 1985, including groundwater monitoring. In accordance with such regulations, the Administrator, or delegated State authority, shall determine the applicability of such monitoring methods, wherever appropriate, at locations and in such a manner as to provide the earliest possible detection of fluid migration into, or in the direction of, underground sources of drinking water from such wells, based on its assessment of the potential for fluid migration from the injection zone that may be harmful to human health or the environment. For purposes of this subsection, a Class I injection well is defined in accordance with 40 CFR 146.05 as in effect on November 1, 1985. (b) REPORT. The Administrator shall submit a report to Congress, no later than September 1987, summarizing the results of State surveys required by the Admin-

SOLE-SOURCE AQUIFER DEMONSTRATION PROGRAM

793

istrator under this section. The report shall include each of the following items of information: (1) The numbers and categories of Class V wells which discharge nonhazardous waste into or above an underground source of drinking water. (2) The primary contamination problems associated with different categories of these disposal wells. (3) Recommendations for minimum design, construction, installation, and siting requirements that should be applied to protect underground sources of drinking water from such contamination wherever necessary.

SOLE-SOURCE AQUIFER DEMONSTRATION PROGRAM 42 USC 300h-6 SECTION 1427. (a) PURPOSE. The purpose of this section is to establish procedures for development, implementation, and assessment of demonstration programs designed to protect critical aquifer protection areas located within areas designated as sole or principal source aquifers under Section 1424(e) of this Act. (b) DEFINITION. For purposes of this section, the term ‘‘critical aquifer protection area’’ means either of the following: (1) All or part of an area located within an area for which an application or designation as a sole or principal source aquifer pursuant to Section 1424(e) has been submitted and approved by the Administrator and which satisfies the criteria established by the Administrator under subsection (d). (2) All or part of an area which is within an aquifer designated as a sole source aquifer as the enactment of the Safe Drinking Water Act Amendments of 1986 and for which an areawide groundwater quality protection plan has been approved under Section 208 of the Clean Water Act prior to such enactment. (c) APPLICATION. Any State, municipal or local government or political subdivision thereof or any planning entity (including any interstate regional planning entity) that identifies a critical aquifer protection area over which it has authority or jurisdiction may apply to the Administrator for the selection of such area for a demonstration program under this section. Any applicant shall consult with other government or planning entities with authority or jurisdiction in such area prior to application. Applicants, other than the Governor, shall submit the application for a demonstration program jointly with the Governor. (d) CRITERIA. Not later than 1 year after the enactment of the Safe Drinking Water Act Amendments of 1986, the Administrator shall, by rule, establish criteria for identifying critical aquifer protection areas under this section. In establishing such criteria, the Administrator shall consider each of the following: (1) The vulnerability of the aquifer to contamination due to hydrogeologic characteristics. (2) The number of persons or the portion of population using the groundwater as a drinking water source.

794

TEXT OF THE SDWA AS AMENDED

(3) The economic, social, and environmental benefits that would result to the area from maintenance of groundwater of high quality. (4) The economic, social, and environmental benefits that would result from degradation of the quality of the groundwater. (e) CONTENTS OF APPLICATION. An application submitted to the Administrator by an applicant for a demonstration program under this section shall meet each of the following requirements: (1) The application shall propose boundaries for the critical aquifer protection area within its jurisdiction. (2) The application shall designate or, if necessary, establish a planning entity (which shall be a public agency and which shall include representation of elected local and State governmental officials) to develop a comprehensive management plan (hereinafter in this section referred to as the ‘‘plan’’) for the critical protection area. Where a local government planning agency exists with adequate authority to carry out this section with respect to any proposed critical protection area, such agency shall be designated as the planning entity. (3) The application shall establish procedures for public participation in the development of the plan, for review, approval, and adoption of the plan, and for assistance to municipalities and other public agencies with authority under State law to implement the plan. (4) The application shall include a hydrogeologic assessment of surface and groundwater resources within the critical protection area. (5) The application shall include a comprehensive management plan for the proposed protection area. (6) The application shall include the measures and schedule proposed for implementation of such plan. (f) COMPREHENSIVE PLAN (1) The objective of a comprehensive management plan submitted by an applicant under this section shall be to maintain the quality of the groundwater in the critical protection area in a manner reasonably expected to protect human health, the environment, and groundwater resources. In order to achieve such objective, the plan may be designed to maintain, to the maximum extent possible, the natural vegetative and hydrogeological conditions. Each of the following elements shall be included in such a protection plan: (A) A map showing the detailed boundary of the critical protection area. (B) An identification of existing and potential point and nonpoint sources of groundwater degradation. (C) An assessment of the relationship between activities on the land surface and groundwater quality. (D) Specific actions and management practice to be implemented in the critical protection area to prevent adverse impacts on groundwater quality. (E) Identification of authority adequate to implement the plan, estimates of program costs, and sources of State matching funds. (2) Such plan may also include the following:

SOLE-SOURCE AQUIFER DEMONSTRATION PROGRAM

795

(A) A determination of the quality of the existing groundwater recharged through the special protection area and the natural recharge capabilities of the special protection area watershed. (B) Requirements designed to maintain existing underground drinking water quality or improve underground drinking water quality if prevailing conditions fail to meet drinking water standards, pursuant to this Act and State law. (C) Limits on Federal, State, and local government, financially assisted activities and projects which may contribute to degradation of such groundwater or any loss of natural surface and subsurface infiltration of purification capability of the special protection watershed. (D) A comprehensive Statement of land use management including emergency contingency planning as it pertains to the maintenance of the quality of underground sources of drinking water or to the improvement of such sources if necessary to meet drinking water standards pursuant to this Act and State law. (E) Actions in the special protection area which would avoid adverse impacts on water quality, recharge capabilities, or both. (F) Consideration of specific techniques, which may include clustering, transfer of development rights, and other innovative measures sufficient to achieve the objectives of this section. (G) Consideration of the establishment of a State institution to facilitate and assist funding a development transfer credit system. (H) A program for State and local implementation of the plan described in this subsection in a manner that will insure the continued, uniform, consistent protection of the critical protection area in accord with the purposes of this section. (I) Pollution abatement measures, if appropriate. (g) PLANS UNDER SECTION 208 OF THE CLEAN WATER ACT. A plan approved before the enactment of the Safe Drinking Water Act Amendments of 1986 under Section 208 of the Clean Water Act to protect a sole-source aquifer designated under Section 1424(e) of this Act shall be considered a comprehensive management plan for the purposes of this section. (h) CONSULTATION AND HEARINGS. During the development of a comprehensive management plan under this section, the planning entity shall consult with, and consider the comments of, appropriate officials of any municipality and State or Federal agency which has jurisdiction over lands and waters within the special protection area, other concerned organizations and technical and citizen advisory committees. The planning entity shall conduct public hearings at places within the special protection area for the purpose of providing the opportunity to comment on any aspect of the plan. (i) APPROVAL OR DISAPPROVAL. Within 120 days after receipt of an application under this section, the Administrator shall approve or disapprove the application. The approval or disapproval shall be based on a determination that the critical protection area satisfies the criteria established under subsection (d) and that a demonstration program for the area would provide protection for groundwater quality consistent with the objective Stated in subsection (f). The Administrator shall

796

TEXT OF THE SDWA AS AMENDED

provide to the Governor a written explanation of the reasons for the disapproval of any such application. Any petitioner may modify and resubmit any application which is not approved. Upon approval of an application, the Administrator may enter into a cooperative agreement with the applicant to establish a demonstration program under this section. (j) GRANTS AND REIMBURSEMENT. Upon entering a cooperative agreement under subsection (i), the Administrator may provide to the applicant, on a matching basis, a grant of 50 per centum of the costs of implementing the plan established under this section. The Administrator may also reimburse the applicant of an approved plan up to 50 per centum of the costs of developing such plan, except for a plan approved under Section 208 of the Clean Water Act. The total amount of grants under this section for any one aquifer, designated under Section 1424(e), shall not exceed $4,000,000 in any one fiscal year. (k) ACTIVITIES FUNDED UNDER OTHER LAW. No funds authorized under this section may be used to fund activities funded under other sections of this Act or the Clean Water Act, the Solid Waste Disposal Act, the Comprehensive Environmental Response, Compensation, and Liability Act of 1980, or other environmental laws. (l) REPORT. Not later than December 31, 1989, each State shall submit to the Administrator a report assessing the impact of the program on groundwater quality and identifying those measures found to be effective in protecting groundwater resources. No later than September 30, 1990, the Administrator shall submit to Congress a report summarizing the State reports, and assessing the accomplishments of the sole-source aquifer demonstration program including an identification of protection methods found to be most effective and recommendations for their application to protect groundwater resources from contamination whenever necessary. (m) SAVINGS PROVISION. Nothing under this section shall be construed to amend, supersede, or abrogate rights to quantities of water which have been established by interstate water compacts, Supreme Court decrees, or State water laws; or any requirement imposed or right provided under any Federal or State environmental or public health statute. (n) AUTHORIZATION. There are authorized to be appropriated to carry out this section not more than the following amounts:

Fiscal Year

Amount

1987 1988 1989 1990 1991 1992–2003

$10,000,000 15,000,000 17,500,000 17,500,000 17,500,000 15,000,000

Matching grants under this section may also be used to implement or update any water quality management plan for a sole or principal source aquifer approved

STATE PROGRAMS TO ESTABLISH WELLHEAD PROTECTION AREAS

797

(before the date of the enactment of this section) by the Administrator under section 208 of the Federal Water Pollution Control Act.

STATE PROGRAMS TO ESTABLISH WELLHEAD PROTECTION AREAS 42 USC 300h-7 SECTION 1428. (a) STATE PROGRAMS. The Governor or Governor’s designee of each State shall, within 3 years of the date of enactment of the Safe Drinking Water Act Amendments of 1986, adopt and submit to the Administrator a State program to protect wellhead areas within their jurisdiction from contaminants which may have any adverse effects on the health of persons. Each State program under this section shall, at a minimum (1) specify the duties of State agencies, local governmental entities, and public waste supply systems with respect to the development and implementation of programs required by this section; (2) for each wellhead, determine the wellhead protection area as defined in subsection (e) based on all reasonably available hydrogeologic information on groundwater flow, recharge and discharge and other information the State deems necessary to adequately determine the wellhead protection area; (3) identify within each wellhead protection area all potential anthropogenic sources of contaminants which may have any adverse effect on the health of persons; (4) describe a program that contains, as appropriate, technical assistance, financial assistance, implementation of control measures, education, training, and demonstration projects to protect the water supply within wellhead protection areas from such contaminants; (5) include contingency plans for the location and provision of alternate drinking water supplies for each public water system in the event of well or wellfield contamination by such contaminants; and (6) include a requirement that consideration be given to all potential sources of such contaminants within the expected wellhead area of a new water well which serves a public water supply system. (b) PUBLIC PARTICIPATION. To the maximum extent possible, each State shall establish procedures, including but not limited to the establishment of technical and citizens advisory committees, to encourage the public to participate in developing the protection program for wellhead areas and source water assessment programs under Section 1453. Such procedures shall include notice and opportunity for public hearing on the State program before it is submitted to the Administrator. (c) DISAPPROVAL (1) IN GENERAL. If, in the judgment of the Administrator, a State program or portion thereof under subsection (a) is not adequate to protect public water systems as required by subsection (a) or a State program under Section 1453 or Section 1418(b) does not meet the applicable requirements of Section 1453 or Section 1418(b), the Administrator shall disapprove such program or portion thereof. A State program developed pursuant to subsection (a) shall be deemed to be adequate

798

TEXT OF THE SDWA AS AMENDED

unless the Administrator determines, within 9 months of the receipt of a State program, that such program (or portion thereof) is inadequate for the purpose of protecting public water systems as required by this section from contaminants that may have any adverse effect on the health of persons. A State program developed pursuant to Section 1453 or Section 1418(b) shall be deemed to meet the applicable requirements of Section 1453 or Section 1418(b) unless the Administrator determines within 9 months of the receipt of the program that such program (or portion thereof) does not meet such requirements. If the Administrator determines that a proposed State program (or any portion thereof) is disapproved, the Administrator shall submit a written Statement of the reasons for such determination to the Governor of the State. (2) MODIFICATION AND RESUBMISSION. Within 6 months after receipt of the Administrator’s written notice under paragraph (1) that any proposed State program (or portion thereof) is disapproved, the Governor or Governor’s designee, shall modify the program based upon the recommendations of the Administrator and resubmit the modified program to the Administrator. (d) FEDERAL ASSISTANCE. After the date 3 years after the enactment of this section, no State shall receive funds authorized to be appropriated under this section except for the purpose of implementing the program and requirements of paragraphs (4) and (6) of subsection (a). (e) DEFINITION OF WELLHEAD PROTECTION AREA. As used in this section, the term ‘‘wellhead protection area’’ means the surface and subsurface area surrounding a water well or wellfield, supplying a public water system, through which contaminants are reasonably likely to move toward and reach such water well or wellfield. The extent of a wellhead protection area, within a State, necessary to provide protection from contaminants which may have any adverse effect on the health of persons is to be determined by the State in the program submitted under subsection (a). Not later than one year after the enactment of the Safe Drinking Water Act Amendments of 1986, the Administrator shall issue technical guidance which States may use in making such determinations. Such guidance may reflect such factors as the radius of influence around a well or wellfield, the depth of drawdown of the water table by such well or wellfield at any given point, the time or rate of travel of various contaminants in various hydrologic conditions, distance from the well or wellfield, or other factors affecting the likelihood of contaminants reaching the well or wellfield, taking into account available engineering pump tests or comparable data, field reconnaissance, topographic information, and the geology of the formation in which the well or wellfield is located. (f) PROHIBITIONS (1) ACTIVITIES UNDER OTHER LAWS. No funds authorized to be appropriated under this section may be used to support activities authorized by the Federal Water Pollution Control Act, the Solid Waste Disposal Act, the Comprehensive Environmental Response, Compensation, and Liability Act of 1980, or other sections of this Act. (2) INDIVIDUAL SOURCES. No funds authorized to be appropriated under this section may be used to bring individual sources of contamination into compliance.

STATE PROGRAMS TO ESTABLISH WELLHEAD PROTECTION AREAS

799

(g) IMPLEMENTATION. Each State shall make every reasonable effort to implement the State wellhead area protection program under this section within 2 years of submitting the program to the Administrator. Each State shall submit to the Administrator a biennial status report describing the State’s progress in implementing the program. Such report shall include amendments to the State program for water wells sited during the biennial period. (h) FEDERAL AGENCIES. Each department, agency, and instrumentality of the executive, legislative, and judicial branches of the Federal Government having jurisdiction over any potential source of contaminants identified by a State program pursuant to the provisions of subsection (a)(3) shall be subject to and comply with all requirements of the State program developed according to subsection (a)(4) applicable to such potential source of contaminants, both substantive and procedural, in the same manner, and to the same extent, as any other person is subject to such requirements, including payment of reasonable charges and fees. The President may exempt any potential source under the jurisdiction of any department, agency, or instrumentality in the executive branch if the President determines it to be in the paramount interest of the United States to do so. No such exemption shall be granted due to the lack of an appropriation unless the President shall have specifically requested such appropriation as part of the budgetary process and the Congress shall have failed to make available such requested appropriations. (i) ADDITIONAL REQUIREMENT (1) IN GENERAL. In addition to the provisions of subsection (a) of this section, States in which there are more than 2500 active wells at which annular injection is used as of January 1, 1986, shall include in their State program a certification that a State program exists and is being adequately enforced that provides protection from contaminants which may have any adverse effect on the health of persons and which are associated with the annular injection or surface disposal of brines associated with oil and gas production. (2) DEFINITION. For purposes of this subsection, the term ‘‘annular injection’’ means the reinjection of brines associated with the production of oil or gas between the production and surface casings of a conventional oil or gas producing well. (3) REVIEW. The Administrator shall conduct a review of each program certified under this section. (4) DISAPPROVAL. If a State fails to include the certification required by this subsection or if in the judgment of the Administrator the State program certified under this subsection is not being adequately enforced, the Administrator shall disapprove the State program submitted under subsection (a) of this section. (j) COORDINATION WITH OTHER LAWS. Nothing in this section shall authorize or require any department, agency, or other instrumentality of the Federal Government or State or local government to apportion, allocate or otherwise regulate the withdrawal or beneficial use of ground or surface waters, so as to abrogate or modify any existing rights to water established pursuant to State or Federal law, including interstate compacts. (k) AUTHORIZATION OF APPROPRIATIONS. Unless the State program is disapproved under this section, the Administrator shall make grants to the State

800

TEXT OF THE SDWA AS AMENDED

for not less than 50 or more than 90 percent of the costs incurred by a State (as determined by the Administrator) in developing and implementing each State program under this section. For purposes of making such grants there is authorized to be appropriated not more than the following amounts: Fiscal Year

Amount

1987 1988 1989 1990 1991 1992–2003

$20,000,000 20,000,000 35,000,000 35,000,000 35,000,000 30,000,000

STATE GROUNDWATER PROTECTION GRANTS 42 USC 300h-8 SECTION 1429. (a) IN GENERAL. The Administrator may make a grant to a State for the development and implementation of a State program to ensure the coordinated and comprehensive protection of ground water resources within the State. (b) GUIDANCE. Not later than 1 year after the date of enactment of the Safe Drinking Water Act Amendments of 1996, and annually thereafter, the Administrator shall publish guidance that establishes procedures for application for State groundwater protection program assistance and that identifies key elements of State groundwater protection programs. (c) CONDITIONS OF GRANTS (1) IN GENERAL. The Administrator shall award grants to States that submit an application that is approved by the Administrator. The Administrator shall determine the amount of a grant awarded pursuant to this paragraph on the basis of an assessment of the extent of groundwater resources in the State and the likelihood that awarding the grant will result in sustained and reliable protection of groundwater quality. (2) INNOVATIVE PROGRAM GRANTS. The Administrator may also award a grant pursuant to this subsection for innovative programs proposed by a State for the prevention of groundwater contamination. (3) ALLOCATION OF FUNDS. The Administrator shall, at a minimum, ensure that, for each fiscal year, not less than 1 percent of funds made available to the Administrator by appropriations to carry out this section are allocated to each State that submits an application that is approved by the Administrator pursuant to this section. (4) LIMITATION ON GRANTS. No grant awarded by the Administrator may be used for a project to remediate groundwater contamination. (d) AMOUNT OF GRANTS. The amount of a grant awarded pursuant to paragraph (1) shall not exceed 50 percent of the eligible costs of carrying out the groundwater protection program that is the subject of the grant (as determined by

EMERGENCY POWERS

801

the Administrator) for the 1-year period beginning on the date that the grant is awarded. The State shall pay a State share to cover the costs of the groundwater protection program from State funds in an amount that is not less than 50 percent of the cost of conducting the program. (e) EVALUATIONS AND REPORTS. Not later than 3 years after the date of enactment of the Safe Drinking Water Act Amendments of 1996, and every 3 years thereafter, the Administrator shall evaluate the State groundwater protection programs that are the subject of grants awarded pursuant to this section and report to the Congress on the status of groundwater quality in the United States and the effectiveness of State programs for groundwater protection. (f) AUTHORIZATION OF APPROPRIATIONS. There are authorized to be appropriated to carry out this section $15,000,000 for each of fiscal years 1997 through 2003.

Part D—Emergency Powers EMERGENCY POWERS 42 USC 300i SECTION 1431. (a) Notwithstanding any other provision of this title, the Administrator, on receipt of information that a contaminant which is present in or is likely to enter a public water system or an underground source of drinking water, or that there is a threatened or potential terrorist attack (or other intentional act designed to disrupt the provision of safe drinking water or to impact adversely the safety of drinking water supplied to communities and individuals), which may present an imminent and substantial endangerment to the health of persons, and that appropriate State and local authorities have not acted to protect the health of such persons, may take such actions as he may deem necessary in order to protect the health of such persons. To the extent he determines it to be practicable in light of such imminent endangerment, he shall consult with the State and local authorities in order to confirm the correctness of the information on which action proposed to be taken under this subsection is based and to ascertain the action which such authorities are or will be taking. The action which the Administrator may take may include (but shall not be limited to) (1) issuing such orders as may be necessary to protect the health of persons who are or may be users of such system (including travelers), including orders requiring the provision of alternative water supplies by persons who caused or contributed to the endangerment, and (2) commencing a civil action for appropriate relief, including a restraining order or permanent or temporary injunction. (b) Any person who violates or fails or refuses to comply with any order issued by the Administrator under subsection (a)(1) may, in an action brought in the appropriate United States district court to enforce such order, be subject to a civil penalty

802

TEXT OF THE SDWA AS AMENDED

of not to exceed $15,000 for each day in which such violation occurs or failure to comply continues.

TAMPERING WITH PUBLIC WATER SYSTEMS 42 USC 300i-1 SECTION 1432. (a) TAMPERING. Any person who tampers with a public water system shall be imprisoned for not more than 20 years, or fined in accordance with Title 18 of the United States Code, or both. (b) ATTEMPT OR THREAT. Any person who attempts to tamper, or makes a threat to tamper, with a public drinking water system will be imprisoned for not more than 10 years, or fined in accordance with Title 18 of the United States Code, or both. (c) CIVIL PENALTY. The Administrator may bring a civil action in the appropriate United States district court (as determined under the provisions of Title 28 of the United States Code) against any person who tampers, attempts to tamper, or makes a threat to tamper with a public water system. The court may impose on such person a civil penalty of not more than $1,000,000 for such tampering or not more than $100,000 for such attempt or threat. (d) DEFINITION OF ‘‘TAMPER’’. For purposes of this section, the term ‘‘tamper’’ means (1) to introduce a contaminant into a public water system with the intention of harming persons; or (2) to otherwise interfere with the operation of a public water system with the intention of harming persons.

TERRORIST AND OTHER INTENTIONAL ACT SECTION 1433. (a) VULNERABILITY ASSESSMENTS. (1) Each community water system serving a population of greater than 3300 persons shall conduct an assessment of the vulnerability of its system to a terrorist attack or other intentional acts intended to substantially disrupt the ability of the system to provide a safe and reliable supply of drinking water. The vulnerability assessment shall include, but not be limited to, a review of pipes and constructed conveyances, physical barriers, water collection, pretreatment, treatment, storage and distribution facilities, electronic, computer or other automated systems which are utilized by the public water system, the use, storage, or handling of various chemicals, and the operation and maintenance of such system. The Administrator, not later than August 1, 2002, after consultation with appropriate departments and agencies of the Federal Government and with State and local governments, shall provide baseline information to

TERRORIST AND OTHER INTENTIONAL ACT

803

community water systems required to conduct vulnerability assessments regarding which kinds of terrorist attacks or other intentional acts are the probable threats to (A) substantially disrupt the ability of the system to provide a safe and reliable supply of drinking water; or (B) otherwise present significant public health concerns. (2) Each community water system referred to in paragraph (1) shall certify to the Administrator that the system has conducted an assessment complying with paragraph (1) and shall submit to the Administrator a written copy of the assessment. Such certification and submission shall be made prior to (A) March 31, 2003, in the case of systems serving a population of 100,000 or more. (B) December 31, 2003, in the case of systems serving a population of 50,000 or more but less than 100,000. (C) June 30, 2004, in the case of systems serving a population greater than 3300 but less than 50,000. (3) Except for information contained in a certification under this subsection identifying the system submitting the certification and the date of the certification, all information provided to the Administrator under this subsection and all information derived therefrom shall be exempt from disclosure under Section 552 of Title 5 of the United States Code. (4) No community water system shall be required under State or local law to provide an assessment described in this section to any State, regional, or local governmental entity solely by reason of the requirement set forth in paragraph (2) that the system submit such assessment to the Administrator. (5) Not later than November 30, 2002, the Administrator, in consultation with appropriate Federal law enforcement and intelligence officials, shall develop such protocols as may be necessary to protect the copies of the assessments required to be submitted under this subsection (and the information contained therein) from unauthorized disclosure. Such protocols shall ensure that (A) each copy of such assessment, and all information contained in or derived from the assessment, is kept in a secure location; (B) only individuals designated by the Administrator may have access to the copies of the assessments; and (C) no copy of an assessment, or part of an assessment, or information contained in or derived from an assessment shall be available to anyone other than an individual designated by the Administrator. At the earliest possible time prior to November 30, 2002, the Administrator shall complete the development of such protocols for the purpose of having them in place prior to receiving any vulnerability assessments from community water systems under this subsection. (6)(A) Except as provided in subparagraph (B), any individual referred to in paragraph (5)(B) who acquires the assessment submitted under paragraph (2), or any reproduction of such assessment, or any information derived from such assessment, and who knowingly or recklessly reveals such assessment, reproduction, or information other than

804

TEXT OF THE SDWA AS AMENDED

(i) to an individual designated by the Administrator under paragraph (5), (ii) for purposes of section 1445 or for actions under section 1431, or (iii) for use in any administrative or judicial proceeding to impose a penalty for failure to comply with this section, shall on conviction be imprisoned for not more than one year or fined in accordance with the provisions of Chapter 227 of Title 18, United States Code, applicable to Class A misdemeanors, or both, and shall be removed from Federal office or employment. (B) Notwithstanding subparagraph (A), an individual referred to in paragraph (5)(B) who is an officer or employee of the United States may discuss the contents of a vulnerability assessment submitted under this section with a State or local official. (7) Nothing in this section authorizes any person to withhold any information from Congress or from any committee or subcommittee of Congress. (b) EMERGENCY RESPONSE PLAN. Each community water system serving a population greater than 3300 shall prepare or revise, where necessary, an emergency response plan that incorporates the results of vulnerability assessments that have been completed. Each such community water system shall certify to the Administrator, as soon as reasonably possible after the enactment of this section, but not later than 6 months after the completion of the vulnerability assessment under subsection (a), that the system has completed such plan. The emergency response plan shall include, but not be limited to, plans, procedures, and identification of equipment that can be implemented or utilized in the event of a terrorist or other intentional attack on the public water system. The emergency response plan shall also include actions, procedures, and identification of equipment which can obviate or significantly lessen the impact of terrorist attacks or other intentional actions on the public health and the safety and supply of drinking water provided to communities and individuals. Community water systems shall, to the extent possible, coordinate with existing Local Emergency Planning Committees established under the Emergency Planning and Community Right-to-Know Act (42 USC 11001 et seq.) when preparing or revising an emergency response plan under this subsection. (c) RECORD MAINTENANCE. Each community water system shall maintain a copy of the emergency response plan completed pursuant to subsection (b) for 5 years after such plan has been certified to the Administrator under this section. (d) GUIDANCE TO SMALL PUBLIC WATER SYSTEMS. The Administrator shall provide guidance to community water systems serving a population of less than 3300 persons on how to conduct vulnerability assessments, prepare emergency response plans, and address threats from terrorist attacks or other intentional actions designed to disrupt the provision of safe drinking water or significantly affect the public health or significantly affect the safety or supply of drinking water provided to communities and individuals. (e) FUNDING. (1) There are authorized to be appropriated to carry out this section not more than $160,000,000 for the fiscal year 2002 and such sums as may be necessary for the fiscal years 2003 through 2005. (2) The Administrator, in coordination with State and local governments, may use funds made available under paragraph (1) to provide financial assistance to community water systems for purposes of compliance with the requirements of subsections

CONTAMINANT PREVENTION, DETECTION, AND RESPONSE

805

(a) and (b) and to community water systems for expenses and contracts designed to address basic security enhancements of critical importance and significant threats to public health and the supply of drinking water as determined by a vulnerability assessment conducted under subsection (a). Such basic security enhancements may include, but shall not be limited to, the following: (A) the purchase and installation of equipment for detection of intruders; (B) the purchase and installation of fencing, gating, lighting, or security cameras; (C) the tamperproofing of manhole covers, fire hydrants, and valve boxes; (D) the rekeying of doors and locks; (E) improvements to electronic, computer, or other automated systems and remote security systems; (F) participation in training programs, and the purchase of training manuals and guidance materials, relating to security against terrorist attacks; (G) improvements in the use, storage, or handling of various chemicals; and (H) security screening of employees or contractor support services Funding under this subsection for basic security enhancements shall not include expenditures for personnel costs, or monitoring, operation, or maintenance of facilities, equipment, or systems. (3) The Administrator may use not more than $5,000,000 from the funds made available under paragraph (1) to make grants to community water systems to assist in responding to and alleviating any vulnerability to a terrorist attack or other intentional acts intended to substantially disrupt the ability of the system to provide a safe and reliable supply of drinking water (including sources of water for such systems) which the Administrator determines to present an immediate and urgent security need. (4) The Administrator may use not more than $5,000,000 from the funds made available under paragraph (1) to make grants to community water systems serving a population of less than 3300 persons for activities and projects undertaken in accordance with the guidance provided to such systems under subsection (d).

CONTAMINANT PREVENTION, DETECTION, AND RESPONSE SECTION 1434. (a) IN GENERAL. The Administrator, in consultation with the Centers for Disease Control and, after consultation with appropriate departments and agencies of the Federal Government and with State and local governments, shall review (or enter into contracts or cooperative agreements to provide for a review of) current and future methods to prevent, detect, and respond to the intentional introduction of chemical, biological, or radiological contaminants into community water systems and source water for community water systems, including each of the following: (1) Methods, means, and equipment, including real-time monitoring systems, designed to monitor and detect various levels of chemical, biological, and radiological contaminants or indicators of contaminants and reduce the likelihood that such

806

TEXT OF THE SDWA AS AMENDED

contaminants can be successfully introduced into public water systems and source water intended to be used for drinking water. (2) Methods and means to provide sufficient notice to operators of public water systems, and individuals served by such systems, of the introduction of chemical, biological, or radiological contaminants and the possible effect of such introduction on public health and the safety and supply of drinking water. (3) Methods and means for developing educational and awareness programs for community water systems. (4) Procedures and equipment necessary to prevent the flow of contaminated drinking water to individuals served by public water systems. (5) Methods, means, and equipment which could negate or mitigate deleterious effects on public health and the safety and supply caused by the introduction of contaminants into water intended to be used for drinking water, including an examination of the effectiveness of various drinking water technologies in removing, inactivating, or neutralizing biological, chemical, and radiological contaminants. (6) Biomedical research into the short-term and long-term impact on public health of various chemical, biological, and radiological contaminants that may be introduced into public water systems through terrorist or other intentional acts. (b) FUNDING. For the authorization of appropriations to carry out this section, see Section 1435(e).

SUPPLY DISRUPTION PREVENTION, DETECTION AND RESPONSE SECTION 1435. (a) DISRUPTION OF SUPPLY OR SAFETY. The Administrator, in coordination with the appropriate departments and agencies of the Federal Government, shall review (or enter into contracts or cooperative agreements to provide for a review of) methods and means by which terrorists or other individuals or groups could disrupt the supply of safe drinking water or take other actions against water collection, pretreatment, treatment, storage, and distribution facilities which could render such water significantly less safe for human consumption, including each of the following: (1) Methods and means by which pipes and other constructed conveyances utilized in public water systems could be destroyed or otherwise prevented from providing adequate supplies of drinking water meeting applicable public health standards. (2) Methods and means by which collection, pretreatment, treatment, storage, and distribution facilities utilized or used in connection with public water systems and collection and pretreatment storage facilities used in connection with public water systems could be destroyed or otherwise prevented from providing adequate supplies of drinking water meeting applicable public health standards. (3) Methods and means by which pipes, constructed conveyances, collection, pretreatment, treatment, storage, and distribution systems that are utilized in connection with public water systems could be altered or affected so as to be subject to cross-contamination of drinking water supplies.

ASSURANCE OF AVAILABILITY OF ADEQUATE SUPPLIES OF CHEMICALS

807

(4) Methods and means by which pipes, constructed conveyances, collection, pretreatment, treatment, storage, and distribution systems that are utilized in connection with public water systems could be reasonably protected from terrorist attacks or other acts intended to disrupt the supply or affect the safety of drinking water. (5) Methods and means by which information systems, including process controls and supervisory control and data acquisition and cyber systems at community water systems, could be disrupted by terrorists or other groups. (b) ALTERNATIVE SOURCES. The review under this section shall also include a review of the methods and means by which alternative supplies of drinking water could be provided in the event of the destruction, impairment, or contamination of public water systems. (c) REQUIREMENTS AND CONSIDERATIONS. In carrying out this section and Section 1434 (1) the Administrator shall ensure that reviews carried out under this section reflect the needs of community water systems of various sizes and various geographic areas of the United States; and (2) the Administrator may consider the vulnerability of, or potential for forced interruption of service for, a region or service area, including community water systems that provide service to the National Capital area. (d) INFORMATION SHARING. As soon as practicable after reviews carried out under this section or Section 1434 have been evaluated, the Administrator shall disseminate, as appropriate as determined by the Administrator, to community water systems information on the results of the project through the Information Sharing and Analysis Center, or other appropriate means. (e) FUNDING. There are authorized to be appropriated to carry out this section and Section 1434 not more than $15,000,000 for the fiscal year 2002 and such sums as may be necessary for the fiscal years 2003 through 2005.

Part E—General Provisions ASSURANCE OF AVAILABILITY OF ADEQUATE SUPPLIES OF CHEMICALS NECESSARY FOR TREATMENT OF WATER 42 USC 300j SECTION 1441. (a) If any person who uses chlorine, activated carbon, lime, ammonia, soda ash, potassium permanganate, caustic soda, or other chemical or substance for the purpose of treating water in any public water system or in any public treatment works determines that the amount of such chemical or substance necessary to effectively treat such water is not reasonably available to him or will not be so available to him when required for the effective treatment of such water, such person may apply to the Administrator for a certification (hereinafter in this section referred to as a ‘‘certification of need’’) that the amount of such chemical or substance which such person requires to effectively treat such water is not reasonably

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TEXT OF THE SDWA AS AMENDED

available to him or will not be so available when required for the effective treatment of such water. (b)(1) An application for a certification of need shall be in such form and submitted in such manner as the Administrator may require and shall (A) specify the persons the applicant determines are able to provide the chemical or substance with respect to which the application is submitted, (B) specify the persons from whom the applicant has sought such chemical or substance, and (C) contain such other information as the Administrator may require. (2) Upon receipt of an application under this section, the Administrator shall (A) publish in the Federal Register a notice of the receipt of the application and a brief summary of it, (B) notify in writing each person whom the President or his delegate (after consultation with the Administrator) determines could be made subject to an order required to be issued upon the issuance of the certification of need applied for in such application, and (C) provide an opportunity for the submission of written comments on such application. The requirements of the preceding sentence of this paragraph shall not apply when the Administrator for good cause finds (and incorporates the finding with a brief Statement of reasons therefore in the order issued) that waiver of such requirements is necessary in order to protect the public health. (3) Within 30 days after (A) the date a notice is published under paragraph (2) in the Federal Register with respect to an application submitted under this section for the issuance of a certification of need, or (B) the date on which such application is received if as authorized by the second sentence of such paragraph no notice is published with respect to such application, the Administrator shall take action either to issue or deny the issuance of a certification of need. (c)(1) If the Administrator finds that the amount of a chemical or substance necessary for an applicant under an application submitted under this section to effectively treat water in a public water system or in a public treatment works is not reasonably available to the applicant or will not be so available to him when required for the effective treatment of such water, the Administrator shall issue a certification of need. Not later than seven days following the issuance of such certification, the President or his delegate shall issue an order requiring the provision to such person of such amounts of such chemical or substance as the Administrator deems necessary in the certification of need issued for such person. Such order shall apply to such manufacturers, producers, processors, distributors, and repackagers of such chemical or substance as the President or his delegate deems necessary and appropriate, except that such order may not apply to any manufacturer, producer, or processor of such chemical or substance who manufactures, produces, or processes (as the case may be) such chemical or substance solely for its own use. Persons subject to an order issued under this section shall be given a reasonable opportunity to consult with the President or his delegate with respect to the implementation of the order. (2) Orders which are to be issued under paragraph (1) to manufacturers, producers, and processors of a chemical or substance shall be equitably apportioned, as far as practicable, among all manufacturers, producers, and processors of such chemical

RESEARCH, TECHNICAL ASSISTANCE, INFORMATION, AND TRAINING

809

or substance; and orders which are to be issued under paragraph (1) to distributors and repackagers of a chemical or substance shall be equitably apportioned, as far as practicable, among all distributors and repackagers of such chemical or substance. In apportioning orders issued under paragraph (1) to manufacturers, producers, processors, distributors, and repackagers of chlorine, the President or his delegate shall, in carrying out the requirements of the preceding sentence, consider (A) the geographical relationship and established commercial relationships between such manufacturers, producers, processors, distributors, and repackagers and the persons for whom the orders are issued; (B) in the case of orders to be issued to producers of chlorine, the (i) amount of chlorine historically supplied by each such producer to treat water in public water systems and public treatment works, and (ii) share of each such producer of the total annual production of chlorine in the United States; and (C) such other factors as the President or his delegate may determine are relevant to the apportionment of orders in accordance with the requirements of the preceding sentence. (3) Subject to subsection (f), any person for whom a certification of need has been issued under this subsection may upon the expiration of the order issued under paragraph (1) upon such certification apply under this section for additional certifications. (d) There shall be available as a defense to any action brought for breach of contract in a Federal or State court arising out of delay or failure to provide, sell, or offer for sale or exchange a chemical or substance subject to an order issued pursuant to subsection (c)(1), that such delay or failure was caused solely by compliance with such order. (e)(1) Whoever knowingly fails to comply with any order issued pursuant to subsection (c)(1) shall be fined not more than $5000 for each such failure to comply. (2) Whoever fails to comply with any order issued pursuant to subsection (c)(1) shall be subject to a civil penalty of not more than $2500 for each such failure to comply. (3) Whenever the Administrator or the President or his delegate has reason to believe that any person is violating or will violate any order issued pursuant to subsection (c)(1), he may petition a United States district court to issue a temporary restraining order or preliminary or permanent injunction (including a mandatory injunction) to enforce the provisions of such order. (f) No certification of need or order issued under this section may remain in effect for more than one year.

RESEARCH, TECHNICAL ASSISTANCE, INFORMATION, AND TRAINING OF PERSONNEL 42 USC 300j-1 SECTION 1442. (a)(1) The Administrator may conduct research, studies, and demonstrations relating to the causes, diagnosis, treatment, control, and prevention

810

TEXT OF THE SDWA AS AMENDED

of physical and mental diseases and other impairments of man resulting directly or indirectly from contaminants in water, or to the provision of a dependably safe supply of drinking water, including (A) improved methods (i) to identify and measure the existence of contaminants in drinking water (including methods which may be used by State and local health and water officials), and (ii) to identify the source of such contaminants; (B) improved methods to identify and measure the health effects of contaminants in drinking water; (C) new methods of treating raw water to prepare it for drinking, so as to improve the efficiency of water treatment and to remove contaminants from water; (D) improved methods for providing a dependably safe supply of drinking water, including improvements in water purification and distribution, and methods of assessing the health-related hazards of drinking water; and (E) improved methods of protecting underground water sources of public water systems from contamination. (2) INFORMATION AND RESEARCH FACILITIES. In carrying out this title, the Administrator is authorized to (A) collect and make available information pertaining to research, investigations, and demonstrations with respect to providing a dependably safe supply of drinking water, together with appropriate recommendations in connection with the information; and (B) make available research facilities of the Agency to appropriate public authorities, institutions, and individuals engaged in studies and research relating to this title. (3) The Administrator shall carry out a study of polychlorinated biphenyl contamination of actual or potential sources of drinking water, contamination of such sources by other substances known or suspected to be harmful to public health, the effects of such contamination, and means of removing, treating, or otherwise controlling such contamination. To assist in carrying out this paragraph, the Administrator is authorized to make grants to public agencies and private nonprofit institutions. (4) The Administrator shall conduct a survey and study of (A) disposal of waste (including residential waste) which may endanger underground water which supplies, or can reasonably be expected to supply, any public water systems, and (B) means of control of such waste disposal. Not later than one year after the date of enactment of this title, he shall transmit to the Congress the results of such survey and study, together with such recommendations as he deems appropriate. (5) The Administrator shall carry out a study of methods of underground injection which do not result in the degradation of underground drinking water sources. (6) The Administrator shall carry out a study of methods of preventing, detecting, and dealing with surface spills of contaminants which may degrade underground water sources for public water systems. (7) The Administrator shall carry out a study of virus contamination of drinking water sources and means of control of such contamination.

RESEARCH, TECHNICAL ASSISTANCE, INFORMATION, AND TRAINING

811

(8) The Administrator shall carry out a study of the nature and extent of the impact on underground water which supplies or can reasonably be expected to supply public water systems of (A) abandoned injection or extraction wells; (B) intensive application of pesticides and fertilizers in underground water recharge areas; and (C) ponds, pools, lagoons, pits, or other surface disposal of contaminants in underground water recharge areas. (9) The Administrator shall conduct a comprehensive study of public water supplies and drinking water sources to determine the nature, extent, sources of, and means of control of contamination by chemicals or other substances suspected of being carcinogenic. Not later than six months after the date of enactment of this title, he shall transmit to the Congress the initial results of such study, together with such recommendations for further review and corrective action as he deems appropriate. (10) The Administrator shall carry out a study of the reaction of chlorine and humic acids and the effects of the contaminants which result from such reaction on public health and on the safety of drinking water, including any carcinogenic effect. (b) The Administrator is authorized to provide technical assistance and to make grants to States, or publicly owned water systems to assist in responding to and alleviating any emergency situation affecting public water systems (including sources of water for such systems) which the Administrator determines to present substantial danger to the public health. Grants provided under this subsection shall be used only to support those actions which (i) are necessary for preventing, limiting, or mitigating danger to the public health in such emergency situation and (ii) would not, in the judgment of the Administrator, be taken without such emergency assistance. The Administrator may carry out the program authorized under this subparagraph as part of, and in accordance with the terms and conditions of, any other program of assistance for environmental emergencies which the Administrator is authorized to carry out under any other provision of law. No limitation on appropriations for any such other program shall apply to amounts appropriated under this subparagraph. (c) Not later than eighteen months after the date of enactment of this subsection, the Administrator shall submit a report to Congress on the present and projected future availability of an adequate and dependable supply of safe drinking water to meet present and projected future need. Such report shall include an analysis of the future demand for drinking water and other competing uses of water, the availability and use of methods to conserve water or reduce demand, the adequacy of present measures to assure adequate and dependable supplies of safe drinking water, and the problems (financial, legal, or other) which need to be resolved in order to assure the availability of such supplies for the future. Existing information and data compiled by the National Water Commission and others shall be utilized to the extent possible. (d) There are authorized to be appropriated to carry out subsection (b) not more than $35,000,000 for the fiscal year 2002 and such sums as may be necessary for each fiscal year thereafter. (e) TECHNICAL ASSISTANCE. The Administrator may provide technical assistance to small public water systems to enable such systems to achieve and maintain compliance with applicable national primary drinking water regulations. Such assis-

812

TEXT OF THE SDWA AS AMENDED

tance may include circuit-rider and multiState regional technical assistance programs, training, and preliminary engineering evaluations. The Administrator shall ensure that technical assistance pursuant to this subsection is available in each State. Each nonprofit organization receiving assistance under this subsection shall consult with the State in which the assistance is to be expended or otherwise made available before using assistance to undertake activities to carry out this subsection. There are authorized to be appropriated to the Administrator to be used for such technical assistance $15,000,000 for each of the fiscal years 1997 through 2003. No portion of any State loan fund established under Section 1452 (relating to State loan funds), and no portion of any funds made available under this subsection may be used for lobbying expenses. Of the total amount appropriated under this subsection, 3 percent shall be used for technical assistance to public water systems owned or operated by Indian Tribes. (f) There are authorized to be appropriated to carry out the provisions of this section, other than subsection (a)(2)(B) and provisions relating to research, $15,000,000 for the fiscal year ending June 30, 1975; $25,000,000 for the fiscal year ending June 30, 1976; $35,000,000 for the fiscal year ending June 30, 1977; $17,000,000 for each of the fiscal years 1978 and 1979; $21,405,000 for the fiscal year ending September 30, 1980; $30,000,000 for the fiscal year ending September 30, 1981; $35,000,000 for the fiscal year ending September 30, 1982. There are authorized to be appropriated to carry out subsection (a)(2)(B) $8,000,000 for each of the fiscal years 1978 through 1982. There are authorized to be appropriated to carry out subsection (a)(2)(B) not more than the following amounts: Fiscal Year 1987 1988 1989 1990 1991

Amount $7,650,000 7,650,000 8,050,000 8,050,000 8,050,000

There are authorized to be appropriated to carry out the provisions of this section [other than subsection (g), subsection (a)(2)(B), and provisions relating to research], not more than the following amounts: Fiscal Year 1987 1988 1989 1990 1991

Amount $35,600,000 35,600,000 38,020,000 38,020,000 38,020,000

GRANTS FOR STATE PROGRAMS

813

(g) The Administrator is authorized to provide technical assistance to small public water systems to enable such systems to achieve and maintain compliance with national drinking water regulations. Such assistance may include ‘‘circuit-rider’’ programs, training, and preliminary engineering studies. There are authorized to be appropriated to carry out this subsection $10,000,000 for each of the fiscal years 1987 through 1991. Not less than the greater of (1) 3 percent of the amounts appropriated under this subsection, or (2) $280,000 shall be utilized for technical assistance to public water systems owned or operated by Indian Tribes.

GRANTS FOR STATE PROGRAMS 43 USC 300j-2 SECTION 1443. (a)(1) From allotments made pursuant to paragraph (4), the Administrator may make grants to States to carry out public water system supervision programs. (2) No grant may be made under paragraph (1) unless an application therefore has been submitted to the Administrator in such form and manner as he may require. The Administrator may not approve an application of a State for its first grant under paragraph (1) unless he determines that the State (A) has established or will establish within one year from the date of such grant a public water system supervision program, and (B) will, within that one year, assume primary enforcement responsibility for public water system within the State. No grant may be made to a State under paragraph (1) for any period beginning more than one year after the date of the State’s first grant unless the State has assumed and maintained primary enforcement responsibility for public water systems within the State. The prohibitions contained in the preceding two sentences shall not apply to such grants when made to Indian Tribes. (3) A grant under paragraph (1) shall be made to cover not more than 75 per centum of the grant recipient’s costs (as determined under regulations of the Administrator) in carrying out, during the one-year period beginning on the date the grant is made, a public water system supervision program. (4) In each fiscal year the Administrator shall, in accordance with regulations, allot the sums appropriated for such year under paragraph (5) among the States on the basis of population, geographical area, number of public water systems, and other relevant factors. No State shall receive less than 1 per centum of the annual appropriation for grants under paragraph (1) provided that the Administrator may by regulation, reduce such percentage in accordance with the criteria specified in this paragraph and provided further that such percentage shall not apply to grants allotted to Guam, American Samoa, or the Virgin Islands.

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TEXT OF THE SDWA AS AMENDED

(5) The prohibition contained in the last sentence of paragraph (2) may be waived by the Administrator with respect to a grant to a State through fiscal year 1979, but such prohibition may only be waived if, in the judgment of the Administrator (A) the State is making diligent effort to assume and maintain primary enforcement responsibility for public water systems within the State; (B) the State has made significant progress toward assuming and maintaining such primary enforcement responsibility; and (C) there is reason to believe the State will assume such primary enforcement responsibility by October 1, 1979. The amount of any grant awarded for the fiscal years 1978 and 1979 pursuant to a waiver under this paragraph may not exceed 75 per centum of the allotment which the State would have received for such fiscal year if it had assumed and maintained such primary enforcement responsibility. The remaining 25 per centum of the amount allotted to such State for such fiscal year shall be retained by the Administrator, and the Administrator may award such amount to such State at such time as the State assumes such responsibility before the beginning of fiscal year 1980. At the beginning of each fiscal year 1979 and 1980 the amounts retained by the Administrator for any preceding fiscal year and not awarded by the beginning fiscal year 1979 or 1980 to the States to which such amounts were originally allotted may be removed from the original allotment and reallotted for fiscal year 1979 or 1980 (as the case may be) to States which have assumed primary enforcement responsibility by the beginning of such fiscal year. (6) The Administrator shall notify the State of the approval or disapproval of any application for a grant under this section (A) within ninety days after receipt of such application, or (B) not later than the first day of the fiscal year for which the grant application is made, whichever is later. (7) AUTHORIZATION. For the purpose of making grants under paragraph (1), there are authorized to be appropriated $100,000,000 for each of fiscal years 1997 through 2003. (8) RESERVATION OF FUNDS BY THE ADMINISTRATOR. If the Administrator assumes the primary enforcement responsibility of a State public water system supervision program, the Administrator may reserve from funds made available pursuant to this subsection an amount equal to the amount that would otherwise have been provided to the State pursuant to this subsection. The Administrator shall use the funds reserved pursuant to this paragraph to ensure the full and effective administration of a public water system supervision program in the State. (9) STATE LOAN FUNDS (A) RESERVATION OF FUNDS. For any fiscal year for which the amount made available to the Administrator by appropriations to carry out this subsection is less than the amount that the Administrator determines is necessary to supplement funds made available pursuant to paragraph (8) to ensure the full and effective administration of a public water system supervision program in a State, the Administrator may reserve from the funds made available to the State under section 1452 (relating to State loan funds) an amount that is equal to the amount of the shortfall. This

GRANTS FOR STATE PROGRAMS

815

paragraph shall not apply to any State not exercising primary enforcement responsibility for public water systems as of the date of enactment of the Safe Drinking Water Act Amendments of 1996. (B) DUTY OF ADMINISTRATOR. If the Administrator reserves funds from the allocation of a State under subparagraph (A), the Administrator shall carry out in the State each of the activities that would be required of the State if the State had primary enforcement authority under Section 1413. (b)(1) From allotments made pursuant to paragraph (4), the Administrator may make grants to States to carry out underground water source protection programs. (2) No grant may be made under paragraph (1) unless an application therefore has been submitted to the Administrator in such form and manner as he may require. No grant may be made to any State under paragraph (1) unless the State has assumed primary enforcement responsibility within two years after the date the Administrator promulgates regulations for State underground injection control programs under Section 1421. The prohibition contained in the preceding sentence shall not apply to such grants when made to Indian Tribes. (3) A grant under paragraph (1) shall be made to cover not more than 75 per centum of the grant recipient’s costs (as determined under regulations of the Administrator) in carrying out, during the one-year period beginning on the date the grant is made, an underground water source protection program. (4) In each fiscal year the Administrator shall, in accordance with regulations, allot the sums appropriated for such year under paragraph (5) among the States on the basis of population, geographical area, and other relevant factors. (5) For purposes of making grants under paragraph (1) there are authorized to be appropriated $5,000,000 for the fiscal year ending June 30, 1976, $7,500,000 for the fiscal year ending June 30, 1977, $10,000,000 for each of the fiscal years 1978 and 1979, $7,795,000 for the fiscal year ending September 30, 1980, $18,000,000 for the fiscal year ending September 30, 1981, and $21,000,000 for the fiscal year ending September 30, 1982. For the purpose of making grants under paragraph (1) there are authorized to be appropriated not more than the following amounts: Fiscal Year

Amount

1987 1988 1989 1990 1991 1992–2003

$19,700,000 19,700,000 20,850,000 20,850,000 20,850,000 15,000,000

(c) For purposes of this section (1) The term ‘‘public water system supervision program’’ means a program for the adoption and enforcement of drinking water regulations (with such variances and exemptions from such regulations under conditions and in a manner which is not less stringent than the conditions under, and the manner in, which variances and

816

TEXT OF THE SDWA AS AMENDED

exemptions may be granted under Sections 1415 and 1416) which are no less stringent than the national primary drinking water regulations under Section 1412, and for keeping records and making reports required by Section 1413(a)(3). (2) The term ‘‘underground water source protection program’’ means a program for the adoption and enforcement of a program which meets the requirements of regulations under Section 1421 and for keeping records and making reports required by Section 1422(b)(1)(A)(ii). Such term includes, where applicable, a program which meets the requirements of Section 1425. (d) NEW YORK CITY WATERSHED PROTECTION PROGRAM (1) IN GENERAL. The Administrator is authorized to provide financial assistance to the State of New York for demonstration projects implemented as part of the watershed program for the protection and enhancement of the quality of source waters of the New York City water supply system, including projects that demonstrate, assess, or provide for comprehensive monitoring and surveillance and projects necessary to comply with the criteria for avoiding filtration contained in 40 CFR 141.71. Demonstration projects which shall be eligible for financial assistance shall be certified to the Administrator by the State of New York as satisfying the purposes of this subsection. In certifying projects to the Administrator, the State of New York shall give priority to monitoring projects that have undergone peer review. (2) REPORT. Not later than 5 years after the date on which the Administrator first provides assistance pursuant to this paragraph, the Governor of the State of New York shall submit a report to the Administrator on the results of projects assisted. (3) MATCHING REQUIREMENTS. Federal assistance provided under this subsection shall not exceed 50 percent of the total cost of the protection program being carried out for any particular watershed or groundwater recharge area. (4) AUTHORIZATION. There are authorized to be appropriated to the Administrator to carry out this subsection for each of fiscal years 1997 through 2003, $15,000,000 for the purpose of providing assistance to the State of New York to carry out paragraph (1).

SPECIAL STUDY AND DEMONSTRATION PROJECT GRANTS; GUARANTEED LOANS 42 USC 300j-3 SECTION 1444. (a) The Administrator may make grants to any person for the purposes of (1) assisting in the development and demonstration (including construction) of any project which will demonstrate a new or improved method, approach, or technology, for providing a dependably safe supply of drinking water to the public; and (2) assisting in the development and demonstration (including construction) of any project which will investigate and demonstrate health implications involved in the reclamation, recycling, and reuse of wastewaters for drinking and the processes and methods for the preparation of safe and acceptable drinking water.

RECORDS AND INSPECTIONS

817

(b) Grants made by the Administrator under this section shall be subject to the following limitations: (1) Grants under this section shall not exceed 66.67 per centum of the total cost construction of any facility, and 75% of any other costs, as determined by the Administrator. (2) Grants under this section shall not be made for any project involving the construction or modification of any facilities for any public water system in a State unless such project has been approved by the State agency charged with the responsibility for safety of drinking water (or if there is no such agency in a State, by the State health authority). (3) Grants under this section shall not be made for any project unless the Administrator determines, after consulting the National Drinking Water Advisory Council, that such project will serve a useful purpose relating to the development and demonstration of new or improved techniques, methods, or technologies for the provision of safe water to the public for drinking. (4) Priority for grants under this section shall be given where there are known or potential public health hazards which require advanced technology for the removal of particles which are too small to be removed by ordinary treatment technology. (c) For the purposes of making grants under subsections (a) and (b) of this section there are authorized to be appropriated $7,500,000 for the fiscal year ending June 30, 1975; and $7,500,000 for the fiscal year ending June 30, 1976; and $10,000,000 for the fiscal year ending June 30, 1977. (d) The Administrator during the fiscal years ending June 30, 1975, and June 30, 1976, shall carry out a program of guaranteeing loans made by private lenders to small public water systems for the purpose of enabling such systems to meet national primary drinking water regulations prescribed under Section 1412. No such guarantee may be made with respect to a system unless (1) such system cannot reasonably obtain financial assistance necessary to comply with regulations from any other source, and (2) the Administrator determines that any facilities constructed with a loan guaranteed under this subsection is not likely to be made obsolete by subsequent changes in primary regulations. The aggregate amount of indebtedness guaranteed with respect to any system may not exceed $50,000. The aggregate amount of indebtedness guaranteed under this subsection may not exceed $50,000,000. The Administrator shall prescribe regulations to carry out this subsection.

RECORDS AND INSPECTIONS 42 USC 300j-4 SECTION 1445. (a)(1)(A) Every person who is subject to any requirement of this title or who is a grantee, shall establish and maintain such records, make such reports, conduct such monitoring, and provide such information as the Administrator may reasonably require by regulation to assist the Administrator in establishing regulations under this title, in determining whether such person has acted or is acting

818

TEXT OF THE SDWA AS AMENDED

in compliance with this title, in administering any program of financial assistance under this title, in evaluating the health risks of unregulated contaminants, or in advising the public of such risks. In requiring a public water system to monitor under this subsection, the Administrator may take into consideration the system size and the contaminants likely to be found in the system’s drinking water. (B) Every person who is subject to a national primary drinking water regulation under Section 1412 shall provide such information as the Administrator may reasonably require, after consultation with the State in which such person is located if such State has primary enforcement responsibility for public water systems, on a case-bycase basis, to determine whether such person has acted or is acting in compliance with this title. (C) Every person who is subject to a national primary drinking water regulation under Section 1412 shall provide such information as the Administrator may reasonably require to assist the Administrator in establishing regulations under Section 1412 of this title, after consultation with States and suppliers of water. The Administrator may not require under this subparagraph the installation of treatment equipment or process changes, the testing of treatment technology, or the analysis or processing of monitoring samples, except where the Administrator provides the funding for such activities. Before exercising this authority, the Administrator shall first seek to obtain the information by voluntary submission. (D) The Administrator shall not later than 2 years after the date of enactment of this subparagraph, after consultation with public health experts, representatives of the general public, and officials of State and local governments, review the monitoring requirements for not fewer than 12 contaminants identified by the Administrator, and promulgate any necessary modifications. (2) MONITORING PROGRAM FOR UNREGULATED CONTAMINANTS (A) ESTABLISHMENT. The Administrator shall promulgate regulations establishing the criteria for a monitoring program for unregulated contaminants. The regulations shall require monitoring of drinking water supplied by public water systems and shall vary the frequency and schedule for monitoring requirements for systems based on the number of persons served by the system, the source of supply, and the contaminants likely to be found, ensuring that only a representative sample of systems serving 10,000 persons or fewer are required to monitor. (B) MONITORING PROGRAM FOR CERTAIN UNREGULATED CONTAMINANTS (i) INITIAL LIST. Not later than 3 years after the date of enactment of the Safe Drinking Water Act Amendments of 1996 and every 5 years thereafter, the Administrator shall issue a list pursuant to subparagraph (A) of not more than 30 unregulated contaminants to be monitored by public water systems and to be included in the national drinking water occurrence database maintained pursuant to subsection (g). (ii) GOVERNORS’ PETITION. The Administrator shall include among the list of contaminants for which monitoring is required under this paragraph each contaminant recommended in a petition signed by the Governor of each of 7 or more States, unless the Administrator determines that the action would prevent the listing of other contaminants of a higher public health concern.

RECORDS AND INSPECTIONS

819

(C) MONITORING PLAN FOR SMALL AND MEDIUM SYSTEMS (i) IN GENERAL. Based on the regulations promulgated by the Administrator, each State may develop a representative monitoring plan to assess the occurrence of unregulated contaminants in public water systems that serve a population of 10,000 or fewer in that State. The plan shall require monitoring for systems representative of different sizes, types, and geographic locations in the State. (ii) GRANTS FOR SMALL SYSTEM COSTS. From funds reserved under Section 1452(o) or appropriated under subparagraph (H), the Administrator shall pay the reasonable cost of such testing and laboratory analysis as are necessary to carry out monitoring under the plan. (D) MONITORING RESULTS. Each public water system that conducts monitoring of unregulated contaminants pursuant to this paragraph shall provide the results of the monitoring to the primary enforcement authority for the system. (E) NOTIFICATION. Notification of the availability of the results of monitoring programs required under paragraph (2)(A) shall be given to the persons served by the system. (F) WAIVER OF MONITORING REQUIREMENT. The Administrator shall waive the requirement for monitoring for a contaminant under this paragraph in a State, if the State demonstrates that the criteria for listing the contaminant do not apply in that State. (G) ANALYTICAL METHODS. The State may use screening methods approved by the Administrator under subsection (i) in lieu of monitoring for particular contaminants under this paragraph. (H) AUTHORIZATION OF APPROPRIATIONS. There are authorized to be appropriated to carry out this paragraph $10,000,000 for each of the fiscal years 1997 through 2003. (b)(1) Except as provided in paragraph (2), the Administrator, or representatives of the Administrator duly designated by him, on presenting appropriate credentials and a written notice to any supplier of water or other person subject to (A) a national primary drinking water regulation prescribed under Section 1412, (B) an applicable underground injection control program, or (C) any requirement to monitor an unregulated contaminant pursuant to subsection (a), or person in charge of any of the property of such supplier or other person referred to in clause (A), (B), or (C), is authorized to enter any establishment, facility, or other property of such supplier or other person in order to determine whether such supplier or other person has acted or is acting in compliance with this title, including for this purpose, inspection, at reasonable times, of records, files, papers, processes, controls, and facilities, or in order to test any feature of a public water system, including its raw water source. The Administrator or the Comptroller General (or any representative designated by either) shall have access for the purpose of audit and examination to any records, reports, or information of a grantee which are required to be maintained under subsection (a) or which are pertinent to any financial assistance under this title. (2) No entry may be made under the first sentence of paragraph (1) in an establishment, facility, or other property of a supplier of water or other person subject to a national primary drinking water regulation if the establishment, facility, or other

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property is located in a State which has primary enforcement responsibility for public water systems unless, before written notice of such entry is made, the Administrator (or his representative) notifies the State agency charged with responsibility for safe drinking water of the reasons for such entry. The Administrator shall, upon a showing by the State agency that such an entry will be detrimental to the administration of the State’s program of primary enforcement responsibility, take such showing into consideration in determining whether to make such entry. No State agency which receives notice under this paragraph of an entry proposed to be made under paragraph (1) may use the information contained in the notice to inform the person whose property is proposed to be entered of the proposed entry; and if a State agency so uses such information, notice to the agency under this paragraph is not required until such time as the Administrator determines the agency has provided him satisfactory assurances that it will no longer so use information contained in a notice under this paragraph. (c) Whoever fails or refuses to comply with any requirement of subsection (a) or to allow the Administrator, the Comptroller General, or representatives of either, to enter and conduct any audit of inspection authorized by subsection (b) shall be subject to a civil penalty of not to exceed $25,000. (d)(1) Subject to paragraph (2), upon a showing satisfactory to the Administrator by any person that any information required under this section from such person, if made public, would divulge trade secrets or secret processes of such person, the Administrator shall consider such information confidential in accordance with the purposes of Section 1905 of Title 18 of the United States Code. If the applicant fails to make a showing satisfactory to the Administrator, the Administrator shall give such applicant thirty days’ notice before releasing the information to which the application relates (unless the public health or safety requires an earlier release of such information). (2) Any information required under this section (A) may be disclosed to other officers, employees, or authorized representatives of the United States concerned with carrying out this title or to committees of the Congress, or when relevant in any proceeding under this title, and (B) shall be disclosed to the extent it deals with the level of contaminants in drinking water. For purposes of this subsection the term ‘‘information required under this section’’ means any papers, books, documents, or information, or any particular part thereof, reported to or otherwise obtained by the Administrator under this section. (e) For purposes of this section, (1) the term ‘‘grantee’’ means any person who applies for or receives financial assistance, by grant, contract, or loan guarantee under this title, and (2) the term ‘‘person’’ includes a Federal agency. (f) INFORMATION REGARDING DRINKING WATER COOLERS. The Administrator may utilize the authorities of this section for purposes of Part F. Any person who manufactures, imports, sells, or distributes drinking water coolers in interstate commerce shall be treated as a supplier of water for purposes of applying the provisions of this section in the case of persons subject to Part F.

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(g) OCCURRENCE DATABASE (1) IN GENERAL. Not later than 3 years after the date of enactment of the Safe Drinking Water Act Amendments of 1996, the Administrator shall assemble and maintain a national drinking water contaminant occurrence database, using information on the occurrence of both regulated and unregulated contaminants in public water systems obtained under subsection (a)(1)(A) or subsection (a)(2) and reliable information from other public and private sources. (2) PUBLIC INPUT. In establishing the occurrence database, the Administrator shall solicit recommendations from the Science Advisory Board, the States, and other interested parties concerning the development and maintenance of a national drinking water contaminant occurrence database, including such issues as the structure and design of the database, data input parameters and requirements, and the use and interpretation of data. (3) USE. The data shall be used by the Administrator in making determinations under Section 1412(b)(1) with respect to the occurrence of a contaminant in drinking water at a level of public health concern. (4) PUBLIC RECOMMENDATIONS. The Administrator shall periodically solicit recommendations from the appropriate officials of the National Academy of Sciences and the States, and any person may submit recommendations to the Administrator, with respect to contaminants that should be included in the national drinking water contaminant occurrence database, including recommendations with respect to additional unregulated contaminants that should be listed under subsection (a)(2). Any recommendation submitted under this clause shall be accompanied by reasonable documentation that (A) the contaminant occurs or is likely to occur in drinking water; and (B) the contaminant poses a risk to public health. (5) PUBLIC AVAILABILITY. The information from the database shall be available to the public in readily accessible form. (6) REGULATED CONTAMINANTS. With respect to each contaminant for which a national primary drinking water regulation has been established, the database shall include information on the detection of the contaminant at a quantifiable level in public water systems (including detection of the contaminant at levels not constituting a violation of the maximum contaminant level for the contaminant). (7) UNREGULATED CONTAMINANTS. With respect to contaminants for which a national primary drinking water regulation has not been established, the database shall include (A) monitoring information collected by public water systems that serve a population of more than 10,000, as required by the Administrator under subsection (a); (B) monitoring information collected from a representative sampling of public water systems that serve a population of 10,000 or fewer; and (C) other reliable and appropriate monitoring information on the occurrence of the contaminants in public water systems that is available to the Administrator. (h) AVAILABILITY OF INFORMATION ON SMALL SYSTEM TECHNOLOGIES. For purposes of Sections 1412(b)(4)(E) and 1415(e) (relating to small

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system variance program), the Administrator may request information on the characteristics of commercially available treatment systems and technologies, including the effectiveness and performance of the systems and technologies under various operating conditions. The Administrator may specify the form, content, and submission date of information to be submitted by manufacturers, States, and other interested persons for the purpose of considering the systems and technologies in the development of regulations or guidance under Sections 1412(b)(4)(E) and 1415(e). (i) SCREENING METHODS. The Administrator shall review new analytical methods to screen for regulated contaminants and may approve such methods as are more accurate or cost-effective than established reference methods for use in compliance monitoring.

NATIONAL DRINKING WATER ADVISORY COUNCIL 42 USC 300j-5 SECTION 1446. (a) There is established a National Drinking Water Advisory Council which shall consist of fifteen members appointed by the Administrator after consultation with the Secretary. Five members shall be appointed from the general public; five members shall be appointed from appropriate State and local agencies concerned with water hygiene and public water supply; and five members shall be appointed from representatives of private organizations or groups demonstrating an active interest in the field of water hygiene and public water supply of which two such members shall be associated with small, rural public water systems. Each member of the Council shall hold office for a term of three years, except that (1) any member appointed to fill a vacancy occurring prior to the expiration of the term for which his predecessor was appointed shall be appointed for the remainder of such term; and (2) the terms of the members first taking office shall expire as follows. Five shall expire three years after the date of enactment of this title, five shall expire two years after such date, and five shall expire one year after such date, as designated by the Administrator at the time of appointment. The members of the Council shall be eligible for reappointment. (b) The Council shall advise, consult with, and make recommendations to, the Administrator on matters relating to activities, functions, and policies of the Agency under this title. (c) Members of the Council appointed under this section shall, while attending meetings or conferences of the Council or otherwise engaged in business of the Council, receive compensation and allowances at the rate to be fixed by the Administrator, but not exceeding the daily equivalent of the annual rate of basic pay in effect for grade GS-18 of the General Schedule for each day (including travel time) during which they are engaged in the actual performance of duties vested in the Council. While away from their homes or regular places of business in the performance of services for the Council, members of the Council shall be allowed travel

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expenses, including per diem in lieu of subsistence, in the same manner as persons employed intermittently in the Government service are allowed expenses under Section 5703(b) or Title 5 of the United States Code. (d) Section 14(a) of the Federal Advisory Committee Act (relating to termination) shall not apply to the Council.

FEDERAL AGENCIES 42 USC 300j-6 SECTION 1447. (a) IN GENERAL. Each department, agency, and instrumentality of the executive, legislative, and judicial branches of the Federal Government (1) owning or operating any facility in a wellhead protection area; (2) engaged in any activity at such facility resulting, or which may result, in the contamination of water supplies in any such area; (3) owning or operating any public water system; or (4) engaged in any activity resulting, or which may result in, underground injection which endangers drinking water (within the meaning of Section 1421(d)(2)), shall be subject to, and comply with, all Federal, State, interstate, and local requirements, both substantive and procedural (including any requirement for permits or reporting or any provisions for injunctive relief and such sanctions as may be imposed by a court to enforce such relief), respecting the protection of such wellhead areas, respecting such public water systems, and respecting any underground injection in the same manner and to the same extent as any person is subject to such requirements, including the payment of reasonable service charges. The Federal, State, interstate, and local substantive and procedural requirements referred to in this subsection include, but are not limited to, all administrative orders and all civil and administrative penalties and fines, regardless of whether such penalties or fines are punitive or coercive in nature or are imposed for isolated, intermittent, or continuing violations. The United States hereby expressly waives any immunity otherwise applicable to the United States with respect to any such substantive or procedural requirement (including, but not limited to, any injunctive relief, administrative order or civil or administrative penalty or fine referred to in the preceding sentence, or reasonable service charge). The reasonable service charges referred to in this subsection include, but are not limited to, fees or charges assessed in connection with the processing and issuance of permits, renewal of permits, amendments to permits, review of plans, studies, and other documents, and inspection and monitoring of facilities, as well as any other nondiscriminatory charges that are assessed in connection with a Federal, State, interstate, or local regulatory program respecting the protection of wellhead areas or public water systems or respecting any underground injection. Neither the United States, nor any agent, employee, or officer thereof, shall be immune or exempt from any process or sanction of any State or Federal Court with respect to the enforcement of any such injunctive relief. No agent, employee, or officer of the United States shall be personally liable for any civil penalty under any

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Federal, State, interstate, or local law concerning the protection of wellhead areas or public water systems or concerning underground injection with respect to any act or omission within the scope of the official duties of the agent, employee, or officer. An agent, employee, or officer of the United States shall be subject to any criminal sanction (including, but not limited to, any fine or imprisonment) under any Federal or State requirement adopted pursuant to this title, but no department, agency, or instrumentality of the executive, legislative, or judicial branch of the Federal Government shall be subject to any such sanction. The President may exempt any facility of any department, agency, or instrumentality in the executive branch from compliance with such a requirement if he determines it to be in the paramount interest of the United States to do so. No such exemption shall be granted due to lack of appropriation unless the President shall have specifically requested such appropriation as a part of the budgetary process and the Congress shall have failed to make available such requested appropriation. Any exemption shall be for a period not in excess of 1 year, but additional exemptions may be granted for periods not to exceed 1 year upon the President’s making a new determination. The President shall report each January to the Congress all exemptions from the requirements of this section granted during the preceding calendar year, together with his reason for granting each such exemption. (b) ADMINISTRATIVE PENALTY ORDERS (1) IN GENERAL. If the Administrator finds that a Federal agency has violated an applicable requirement under this title, the Administrator may issue a penalty order assessing a penalty against the Federal agency. (2) PENALTIES. The Administrator may, after notice to the agency, assess a civil penalty against the agency in an amount not to exceed $25,000 per day per violation. (3) PROCEDURE. Before an administrative penalty order issued under this subsection becomes final, the Administrator shall provide the agency an opportunity to confer with the Administrator and shall provide the agency notice and an opportunity for a hearing on the record in accordance with Chapters 5 and 7 of Title 5, United States Code. (4) PUBLIC REVIEW (A) IN GENERAL. Any interested person may obtain review of an administrative penalty order issued under this subsection. The review may be obtained in the United States District Court for the District of Columbia or in the United States District Court for the district in which the violation is alleged to have occurred by the filing of a complaint with the court within the 30-day period beginning on the date the penalty order becomes final. The person filing the complaint shall simultaneously send a copy of the complaint by certified mail to the Administrator and the Attorney General. (B) RECORD. The Administrator shall promptly file in the court a certified copy of the record on which the order was issued. (C) STANDARD OF REVIEW. The court shall not set aside or remand the order unless the court finds that there is not substantial evidence in the record, taken as a whole, to support the finding of a violation or that the assessment of the penalty by the Administrator constitutes an abuse of discretion.

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(D) PROHIBITION ON ADDITIONAL PENALTIES. The court may not impose an additional civil penalty for a violation that is subject to the order unless the court finds that the assessment constitutes an abuse of discretion by the Administrator. (c) LIMITATION ON STATE USE OF FUNDS COLLECTED FROM FEDERAL GOVERNMENT. Unless a State law in effect on the date of enactment of the Safe Drinking Water Act Amendments of 1996 or a State constitution requires the funds to be used in a different manner, all funds collected by a State from the Federal Government from penalties and fines imposed for violation of any substantive or procedural requirement referred to in subsection (a) shall be used by the State only for projects designed to improve or protect the environment or to defray the costs of environmental protection or enforcement. (d)(1) Nothing in the Safe Drinking Water Amendments of 1977 shall be construed to alter or affect the status of American Indian lands or water rights nor to waive any sovereignty over Indian lands guaranteed by treaty or statute. (2) For the purposes of this Act, the term ‘‘Federal agency’’ shall not be construed to refer to or include any American Indian Tribe, nor to the Secretary of the Interior in his capacity as trustee of Indian lands. (e) WASHINGTON AQUEDUCT. The Secretary of the Army shall not pass the cost of any penalty assessed under this title on to any customer, user, or other purchaser of drinking water from the Washington Aqueduct system, including finished water from the Dalecarlia or McMillan treatment plant.

JUDICIAL REVIEW 42 USC 300j-7 SECTION 1448. (a) A petition for review of (1) actions pertaining to the establishment of national primary drinking water regulations (including maximum contaminant level goals) may be filed only in the United States Court of Appeals for the District of Columbia circuit; and (2) any other final action of the Administrator under this Act may be filed in the circuit in which the petitioner resides or transacts business which is directly affected by the action. Any such petition shall be filed within the 45-day period beginning on the date of the promulgation of the regulation or any other final Agency action with respect to which review is sought or on the date of the determination with respect to which review is sought, and may be filed after the expiration of such 45-day period if the petition is based solely on grounds arising after the expiration of such period. Action of the Administrator with respect to which review could have been obtained under this subsection shall not be subject to judicial review in any civil or criminal proceeding for enforcement or in any civil action to enjoin enforcement. In any petition concerning the assessment of a civil penalty pursuant to Section 1414(g)(3)(B), the petitioner shall simultaneously send a copy of the compliant by certified mail to the Administrator and the Attorney General. The court shall set

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aside and remand the penalty order if the court finds that there is not substantial evidence in the record to support the finding of a violation or that the assessment of the penalty by the Administrator constitutes an abuse of discretion. (b) The United States district courts shall have jurisdiction of actions brought to review (1) the granting of, or the refusing to grant, a variance or exemption under Section 1415 or 1416 or (2) the requirements of any schedule prescribed for a variance or exemption under such section or the failure to prescribe such a schedule. Such an action may only be brought upon a petition for review filed with the court within the 45-day period beginning on the date the action sought to be reviewed is taken or, in the case of a petition to review the refusal to grant a variance or exemption or the failure to prescribe a schedule, within the 45-day period beginning on the date action is required to be taken on the variance, exemption, or schedule, as the case may be. A petition for such review may be filed after the expiration of such period. Action with respect to which review could have been obtained under this subsection shall not be subject to judicial review in any civil or criminal proceeding for enforcement or in any civil action to enjoin enforcement. (c) In any judicial proceeding in which review is sought of a determination under this title required to be made on the record after notice and opportunity for hearing, if any party applies to the court for leave to adduce additional evidence and shows to the satisfaction of the court that such additional evidence is material and that there were reasonable grounds for the failure to adduce such evidence in the proceeding before the Administrator, the court may order such additional evidence (and evidence in rebuttal thereof) to be taken before the Administrator, in such manner and upon such terms and conditions as the court may deem proper. The Administrator may modify his findings as to the facts, or make new findings, by reason of the additional evidence so taken, and he shall file such modified or new findings, and his recommendation, if any, for the modification or setting aside of his original determination, with the return of such additional evidence.

CITIZEN’S CIVIL ACTION 42 USC 300j-8 SECTION 1449. (a) Except as provided in subsection (b) of this section, any person may commence a civil action on his own behalf (1) against any person (including (A) the United States, and (B) any other governmental instrumentality or agency to the extent permitted by the Eleventh Amendment to the Constitution) who is alleged to be in violation of any requirement prescribed by or under this title; (2) against the Administrator where there is alleged a failure of the Administrator to perform any act or duty under this title which is not discretionary with the Administrator; or (3) for the collection of a penalty by the United States Government (and associated costs and interest) against any Federal agency that fails, by the date that is 18

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months after the effective date of a final order to pay a penalty assessed by the Administrator under section 1429(b), to pay the penalty. No action may be brought under paragraph (1) against a public water system for a violation of a requirement prescribed by or under this title which occurred within the 27-month period beginning on the first day of the month in which this title is enacted. The United States district courts shall have jurisdiction, without regard to the amount of controversy or the citizenship of the parties, to enforce in an action brought under this subsection any requirement prescribed by or under this title or to order the Administrator to perform an act, or duty described in paragraph (2), as the case may be. (b) No civil action may be commenced (1) under subsection (a)(1) of this section respecting violation or a requirement prescribed by or under this title (A) prior to sixty days after the plaintiff has given notice of such violation (i) to the Administrator, (ii) to any alleged violator of such requirement and (iii) to the State in which the violation occurs, or (B) if the Administrator, the Attorney General, or the State has commenced and is diligently prosecuting a civil action in a court of the United States to require compliance with such requirement, but in any such action in a court of the United States any person may intervene as a matter of right; or (2) under subsection (a)(2) of this section prior to sixty days after the plaintiff has given notice of such action to the Administrator; or (3) under subsection (a)(3) prior to 60 days after the plaintiff has given notice of such action to the Attorney General and to the Federal agency. Notice required by this subsection shall be given in such manner as the Administrator shall prescribe by regulation. No person may commence a civil action under subsection (a) to require a State to prescribe a schedule under Section 1415 or 1416 for a variance or exemption, unless such person shows to the satisfaction of the court that the State has in a substantial number of cases failed to prescribe such schedules. (c) In any action under this section, the Administrator or the Attorney General, if not a party, may intervene as a matter of right. (d) The court, in issuing any final order in any action brought under subsection (a) of this section, may award costs of litigation (including reasonable attorney and expert witness fees) to any party whenever the court determines such an award is appropriate. The court may, if a temporary restraining order or preliminary injunction is sought, require the filing of a bond or equivalent security in accordance with the Federal Rules of Civil Procedure. (e) Nothing in this section shall restrict any right which any person (or class of persons) may have under any statute or common law to seek enforcement of any requirement prescribed by or under this title or to seek any other relief. Nothing in this section or in any other law of the United States shall be construed to prohibit, exclude, or restrict any State or local government from (1) bringing any action or obtaining any remedy or sanction in any State or local court, or (2) bringing any administrative action or obtaining any administrative remedy or sanction, against any agency of the United States under State or local law to enforce

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any requirement respecting the provision of safe drinking water or respecting any underground injection control program. Nothing in this section shall be construed to authorize judicial review of regulations or orders of the Administrator under this title, except as provided in Section 1448. For provisions providing for application of certain requirements to such agencies in the same manner as to nongovernmental entities, see Section 1447.

GENERAL PROVISIONS 42 USC 300j-9 SECTION 1450. (a)(1) The Administrator is authorized to prescribe such regulations as are necessary or appropriate to carry out his functions under this title. (2) The Administrator may delegate any of his functions under this title (other than prescribing regulations) to any officer or employee of the Agency. (b) The Administrator, with the consent of the head of any other agency of the United States, may utilize such officers and employees of such agency as he deems necessary to assist him in carrying out the purposes of this title. (c) Upon the request of a State or interstate agency, the Administrator may assign personnel of the Agency to such State or interstate agency for the purposes of carrying out the provisions of this title. (d)(1) The Administrator may make payments of grants under this title (after necessary adjustment on account of previously made underpayments or overpayments) in advance or by way of reimbursement, and in such installments and on such conditions as he may determine. (2) Financial assistance may be made available in the form of grants only to individuals and nonprofit agencies or institutions. For purposes of this paragraph, the term ‘‘nonprofit agency or institution’’ means an agency or institution no part of the net earnings of which inure, or may lawfully inure, to the benefit of any private shareholder or individual. (e) The Administrator shall take such action as may be necessary to assure compliance with provisions of the Act of March 3, 1931 [known as the Davis– Bacon Act; 40 USC 276a-276-a(5)]. The Secretary of Labor shall have, with respect to the labor standards specified in this subsection, the authority and functions set forth in Reorganization Plan Numbered 14 of 1950 (Fed. Reg. 15:3176; 64 Stat. 1267) and section 2 of the Act of June 13, 1934 (40 USC 276c). (f) The Administrator shall request the Attorney General to appear and represent him in any civil action instituted under this title to which the Administrator is a party. Unless, within a reasonable time, the Attorney General notifies the Administrator that he will appear in such action, attorneys appointed by the Administrator shall appear and represent him. (g) The provisions of this title shall not be construed as affecting any authority of the Administrator under Part G of Title III of this Act.

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(h) Not later than April 1 of each year, the Administrator shall submit to the Committee on Commerce of the Senate and the Committee on InterState and Foreign Commerce of the House of Representatives a report respecting the activities of the Agency under this title and containing such recommendations for legislation as he considers necessary. The report of the Administrator under this subsection, which is due not later than April 1, 1975, and each subsequent report of the Administrator under this subsection shall include a Statement on the actual and anticipated cost to public water systems in each State of compliance with the requirements of this title. The Office of Management and Budget may review any report required by this subsection before its submission to such committees of Congress, but the Office may not revise any such report, require any revision in any such report, or delay its submission beyond the day prescribed for its submission, and may submit to such committees of Congress its comments respecting any such report. (i)(1) No employer may discharge any employee or otherwise discriminate against any employee with respect to his compensation, terms, conditions, or privileges of employment because the employee (or any person acting pursuant to a request of the employee) has (A) commenced, caused to be commenced, or is about to commence or cause to be commenced a proceeding under this title or a proceeding for the administration or enforcement of drinking water regulations or underground injection control programs of a State. (B) testified or is about to testify in any such proceeding, or (C) assisted or participated or is about to assist or participate in any manner in such proceeding or in other action to carry out the purposes of this title. (2)(A) Any employee who believes that he has been discharged or otherwise discriminated against by any person in violation of paragraph (1) may, within 30 days after such violation occurs, file (or have any person file on his behalf) a complaint with the Secretary of Labor (hereinafter in this subsection referred to as the ‘‘Secretary’’) alleging such discharge or discrimination. Upon receipt of such a complaint, the Secretary shall notify the person named in the complaint of the filing of the complaint. (B)(i) Upon receipt of a complaint filed under subparagraph (A), the Secretary shall conduct an investigation of the violation alleged in the complaint. Within 30 days of the receipt of such complaint, the Secretary shall complete such investigation and shall notify in writing the complainant (and any person acting in his behalf) and the person alleged to have committed such violation of the results of the investigation conducted pursuant to this subparagraph. Within 90 days of the receipt of such complaint the secretary shall, unless the proceeding on the complaint is terminated by the Secretary on the basis of a settlement entered into by the Secretary and the person alleged to have committed such violation, issue an order either providing the relief prescribed by clause (ii) or denying the complaint. An order of the Secretary shall be made on the record after notice and opportunity for agency hearing. The Secretary may not enter into a settlement terminating a proceeding on a complaint without the participation and consent of the complainant.

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(ii) If in response to a complaint filed under subparagraph (A) the Secretary determines that a violation of paragraph (1) has occurred, the Secretary shall order (I) the person who committed such violation to take affirmative action to abate the violation, (II) such person to reinstate the complainant to his former position together with the compensation (including back pay), terms, conditions, and privileges of his employment, (III) compensatory damages, and (IV) where appropriate, exemplary damages. If such an order is issued, the Secretary, at the request of the complainant, shall assess against the person whom the order is issued a sum equal to the aggregate amount of all costs and expenses (including attorneys’ fees) reasonably incurred, as determined by the Secretary, by the complainant for, or in connection with, the bringing of the complaint upon which the order was issued. (3)(A) Any person adversely affected or aggrieved by an order issued under paragraph (2) may obtain review of the order in the United States Court of Appeals for the circuit in which the violation, with respect to which the order was issued, allegedly occurred. The petition for review must be filed within sixty days from the issuance of the secretary’s order. Review shall conform to Chapter 7 of Title 5 of the United States Code. The commencement of proceedings under this subparagraph shall not, unless ordered by the court, operate as a stay of the Secretary’s order. (B) An order of the Secretary with respect to which review could have been obtained under subparagraph (A) shall not be subject to judicial review in any criminal or other civil proceeding. (4) Whenever a person has failed to comply with an order issued under paragraph (2)(B), the Secretary shall file a civil action in the United States District Court for the district in which the violation was found to occur to enforce such order. In actions brought under this paragraph, the district court shall have jurisdiction to grant all appropriate relief including, but not limited to injunctive relief, compensatory, and exemplary damages. (5) Any nondiscretionary duty imposed by this section is enforceable in mandamus proceeding brought under Section 1361 of Title 28 of the United States Code. (6) Paragraph (1) shall not apply with respect to any employee who, acting without direction from his employer (or the employer’s agent), deliberately causes a violation of any requirement of this title.

APPOINTMENT OF SCIENTIFIC, ETC., PERSONNEL BY ADMINISTRATOR OF EPA FOR IMPLEMENTATION OF RESPONSIBILITIES; COMPENSATION 42 USC 300j-10 SECTION 1451A. To the extent that the Administrator of the Environmental Protection Agency deems such action necessary to the discharge of his functions under this subchapter (relating to safe drinking water) and under other provisions of law, he may appoint personnel to fill not more than thirty scientific, engineering, professional, legal, and administrative positions within the U.S. Environmental

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Protection Agency without regard to the civil service laws and may fix the compensation of such personnel not in excess of the maximum rate payable for GS-18 of the General Schedule under Section 5332 of Title 5.

INDIAN TRIBES 42 USC 300j-11 SECTION 1451. (a) IN GENERAL. Subject to the provisions of subsection (b), the Administrator (1) is authorized to treat Indian Tribes as States under this title, (2) may delegate to such Tribes primary enforcement responsibility for public water systems and for underground injection control, and (3) may provide such Tribes grant and contract assistance to carry out functions provided by this title. (b) EPA REGULATIONS (1) SPECIFIC PROVISIONS. The Administrator shall, within 18 months after the enactment of the Safe Drinking Water Act Amendments of 1986, promulgate final regulations specifying those provisions of this title for which it is appropriate to treat Indian Tribes as States. Such treatment shall be authorized only if (A) the Indian Tribe is recognized by the Secretary of the Interior and has a governing body carrying out substantial governmental duties and powers; (B) the functions to be exercised by the Indian Tribe are within the area of the Tribal Government’s jurisdiction; and (C) the Indian Tribe is reasonably expected to be capable, in the Administrator’s judgment, of carrying out the functions to be exercised in a manner consistent with the terms and purposes of this title and of all applicable regulations. (2) PROVISIONS WHERE TREATMENT AS STATE INAPPROPRIATE. For any provision of this title where treatment of Indian Tribes as identical to States is inappropriate, administratively infeasible or otherwise inconsistent with the purposes of this title, the Administrator may include in the regulations promulgated under this section, other means for administering such provision in a manner that will achieve the purpose of the provision. Nothing in this section shall be construed to allow Indian Tribes to assume or maintain primary enforcement responsibility for public water systems or for underground injection control in a manner less protective of the health of persons than such responsibility may be assumed or maintained by a State. An Indian Tribe shall not be required to exercise criminal enforcement jurisdiction for purposes of complying with the preceding sentence.

STATE REVOLVING LOAN FUNDS 42 USC 300j-12 SECTION 1452. (a) GENERAL AUTHORITY

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(1) GRANTS TO STATES TO ESTABLISH STATE LOAN FUNDS (A) IN GENERAL. The Administrator shall offer to enter into agreements with eligible States to make capitalization grants, including letters of credit, to the States under this subsection to further the health protection objectives of this title, promote the efficient use of fund resources, and for other purposes as are specified in this title. (B) ESTABLISHMENT OF FUND. To be eligible to receive a capitalization grant under this section, a State shall establish a drinking water treatment revolving loan fund (referred to in this section as a ‘‘state loan fund’’) and comply with the other requirements of this section. Each grant to a State under this section shall be deposited in the State loan fund established by the State, except as otherwise provided in this section and in other provisions of this title. No funds authorized by other provisions of this title to be used for other purposes specified in this title shall be deposited in any State loan fund. (C) EXTENDED PERIOD. The grant to a State shall be available to the State for obligation during the fiscal year for which the funds are authorized and during the following fiscal year, except that grants made available from funds provided prior to fiscal year 1997 shall be available for obligation during each of the fiscal years 1997 and 1998. (D) ALLOTMENT FORMULA. Except as otherwise provided in this section, funds made available to carry out this section shall be allotted to States that have entered into an agreement pursuant to this section (other than the District of Columbia) in accordance with (i) for each of fiscal years 1995 through 1997, a formula that is the same as the formula used to distribute public water system supervision grant funds under Section 1443 in fiscal year 1995, except that the minimum proportionate share established in the formula shall be 1 percent of available funds, and the formula shall be adjusted to include a minimum proportionate share for the State of Wyoming and the District of Columbia; and (ii) for fiscal year 1998 and each subsequent fiscal year, a formula that allocates to each State the proportional share of the State needs identified in the most recent survey conducted pursuant to subsection (h), except that the minimum proportionate share provided to each State shall be the same as the minimum proportionate share provided under clause (i). (E) REALLOTMENT. The grants not obligated by the last day of the period for which the grants are available shall be reallotted according to the appropriate criteria set forth in subparagraph (D), except that the Administrator may reserve and allocate 10 percent of the remaining amount for financial assistance to Indian Tribes in addition to the amount allotted under subsection (i) and none of the funds reallotted by the Administrator shall be reallotted to any State that has not obligated all sums allotted to the State pursuant to this section during the period in which the sums were available for obligation. (F) NONPRIMACY STATES. The State allotment for a State not exercising primary enforcement responsibility for public water systems shall not be deposited in any such fund but shall be allotted by the Administrator under this subparagraph.

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Pursuant to Section 1443(a)(9)(A) such sums allotted under this subparagraph shall be reserved as needed by the Administrator to exercise primary enforcement responsibility under this title in such State, and the remainder shall be reallotted to States exercising primary enforcement responsibility for public water systems for deposit in such funds. Whenever the Administrator makes a final determination pursuant to Section 1413(b) that the requirements of Section 1413(a) are no longer being met by a State, additional grants for such State under this title shall be immediately terminated by the Administrator. This subparagraph shall not apply to any State not exercising primary enforcement responsibility for public water systems as of the date of enactment of the Safe Drinking Water Act Amendments of 1996. (G) OTHER PROGRAMS (i) NEW SYSTEM CAPACITY. Beginning in fiscal year 1999, the Administrator shall withhold 20 percent of each capitalization grant made pursuant to this section to a State unless the State has met the requirements of Section 1420(a) (relating to capacity development) and shall withhold 10 percent for fiscal year 2001, 15 percent for fiscal year 2002, and 20 percent for fiscal year 2003 if the State has not complied with the provisions of Section 1420(c) (relating to capacity development strategies). Not more than a total of 20 percent of the capitalization grants made to a State in any fiscal year may be withheld under the preceding provisions of this clause. All funds withheld by the Administrator pursuant to this clause shall be reallotted by the Administrator on the basis of the same ratio as is applicable to funds allotted under subparagraph (D). None of the funds reallotted by the Administrator pursuant to this paragraph shall be allotted to a State unless the State has met the requirements of Section 1420 (relating to capacity development). (ii) OPERATOR CERTIFICATION. The Administrator shall withhold 20 percent of each capitalization grant made pursuant to this section unless the State has met the requirements of Section 1419 (relating to operator certification). All funds withheld by the Administrator pursuant to this clause shall be reallotted by the Administrator on the basis of the same ratio as applicable to funds allotted under subparagraph (D). None of the funds reallotted by the Administrator pursuant to this paragraph shall be allotted to a State unless the State has met the requirements of Section 1419 (relating to operator certification). (2) USE OF FUNDS. Except as otherwise authorized by this title, amounts deposited in a State loan fund, including loan repayments and interest earned on such amounts, shall be used only for providing loans or loan guarantees, or as a source of reserve and security for leveraged loans, the proceeds of which are deposited in a State loan fund established under paragraph (1), or other financial assistance authorized under this section to community water systems and nonprofit noncommunity water systems, other than systems owned by Federal agencies. Financial assistance under this section may be used by a public water system only for expenditures (not including monitoring, operation, and maintenance expenditures) of a type or category which the Administrator has determined, through guidance, will facilitate compliance with national primary drinking water regulations applicable to the system under Section 1412 or otherwise significantly further the health protection objectives of this title. The funds may also be used to provide loans to a system

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referred to in Section 1401(4)(B) for the purpose of providing the treatment described in Section 1401(4)(B)(i)(III). The funds shall not be used for the acquisition of real property or interests therein, unless the acquisition is integral to a project authorized by this paragraph and the purchase is from a willing seller. Of the amount credited to any State loan fund established under this section in any fiscal year, 15 percent shall be available solely for providing loan assistance to public water systems which regularly serve fewer than 10,000 persons to the extent such funds can be obligated for eligible projects of public water systems. (3) LIMITATION (A) IN GENERAL. Except as provided in subparagraph (B), no assistance under this section shall be provided to a public water system that (i) does not have the technical, managerial, and financial capability to ensure compliance with the requirements of this title; or (ii) is in significant noncompliance with any requirement of a national primary drinking water regulation or variance. (B) RESTRUCTURING. A public water system described in subparagraph (A) may receive assistance under this section if (i) the use of the assistance will ensure compliance; and (ii) if subparagraph (A)(i) applies to the system, the owner or operator of the system agrees to undertake feasible and appropriate changes in operations (including ownership, management, accounting, rates, maintenance, consolidation, alternative water supply, or other procedures) if the the State determines that the measures are necessary to ensure that the system has the technical, managerial, and financial capability to comply with the requirements of this title over the long term. (C) REVIEW. Prior to providing assistance under this section to a public water system that is in significant noncompliance with any requirement of a national primary drinking water regulation or variance, the State shall conduct a review to determine whether subparagraph (A)(i) applies to the system. (b) INTENDED-USE PLANS (1) IN GENERAL. After providing for public review and comment, each State that has entered into a capitalization agreement pursuant to this section shall annually prepare a plan that identifies the intended uses of the amounts available to the State loan fund of the State. (2) CONTENTS. An intended use plan shall include (A) a list of the projects to be assisted in the first fiscal year that begins after the date of the plan, including a description of the project, the expected terms of financial assistance, and the size of the community served; (B) the criteria and methods established for the distribution of funds; and (C) a description of the financial status of the State loan fund and the short-term and long-term goals of the State loan fund. (3) USE OF FUNDS (A) IN GENERAL. An intended use plan shall provide, to the maximum extent practicable, that priority for the use of funds be given to projects that (i) address the most serious risk to human health;

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(ii) are necessary to ensure compliance with the requirements of this title (including requirements for filtration); and (iii) assist systems most in need on a per household basis according to State affordability criteria. (B) LIST OF PROJECTS. Each State shall, after notice and opportunity for public comment, publish and periodically update a list of projects in the State that are eligible for assistance under this section, including the priority assigned to each project and, to the extent known, the expected funding schedule for each project. (c) FUND MANAGEMENT. Each State loan fund under this section shall be established, maintained, and credited with repayments and interest. The fund corpus shall be available in perpetuity for providing financial assistance under this section. To the extent amounts in the fund are not required for current obligation or expenditure, such amounts shall be invested in interest bearing obligations. (d) ASSISTANCE FOR DISADVANTAGED COMMUNITIES (1) LOAN SUBSIDY. Notwithstanding any other provision of this section, in any case in which the State makes a loan pursuant to subsection (a)(2) to a disadvantaged community or to a community that the State expects to become a disadvantaged community as the result of a proposed project, the State may provide additional subsidization (including forgiveness of principal). (2) TOTAL AMOUNT OF SUBSIDIES. For each fiscal year, the total amount of loan subsidies made by a State pursuant to paragraph (1) may not exceed 30 percent of the amount of the capitalization grant received by the State for the year. (3) DEFINITION OF DISADVANTAGED COMMUNITY. In this subsection, the term ‘‘disadvantaged community’’ means the service area of a public water system that meets affordability criteria established after public review and comment by the State in which the public water system is located. The Administrator may publish information to assist States in establishing affordability criteria. (e) STATE CONTRIBUTION. Each agreement under subsection (a) shall require that the State deposit in the State loan fund from State moneys an amount equal to at least 20 percent of the total amount of the grant to be made to the State on or before the date on which the grant payment is made to the State, except that a State shall not be required to deposit such amount into the fund prior to the date on which each grant payment is made for fiscal years 1994, 1995, 1996, and 1997 if the State deposits the State contribution amount into the State loan fund prior to September 30, 1999. (f) TYPES OF ASSISTANCE. Except as otherwise limited by State law, the amounts deposited into a State loan fund under this section may be used only (1) to make loans, on the condition that (A) the interest rate for each loan is less than or equal to the market interest rate, including an interest-free loan; (B) principal and interest payments on each loan will commence not later than 1 year after completion of the project for which the loan was made, and each loan will be fully amortized not later than 20 years after the completion of the project, except that in the case of a disadvantaged community (as defined in subsection (d)(3)), a State may provide an extended term for a loan, if the extended term

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(i) terminates not later than the date that is 30 years after the date of project completion; and (ii) does not exceed the expected design life of the project; (C) the recipient of each loan will establish a dedicated source of revenue (or, in the case of a privately owned system, demonstrate that there is adequate security) for the repayment of the loan; and (D) the State loan fund will be credited with all payments of principal and interest on each loan; (2) to buy or refinance the debt obligation of a municipality or an intermunicipal or interstate agency within the State at an interest rate that is less than or equal to the market interest rate in any case in which a debt obligation is incurred after July 1, 1993; (3) to guarantee, or purchase insurance for, a local obligation (all of the proceeds of which finance a project eligible for assistance under this section) if the guarantee or purchase would improve credit market access or reduce the interest rate applicable to the obligation; (4) as a source of revenue or security for the payment of principal and interest on revenue or general obligation bonds issued by the State if the proceeds of the sale of the bonds will be deposited into the State loan fund; and (5) to earn interest on the amounts deposited into the State loan fund. (g) ADMINISTRATION OF STATE LOAN FUNDS (1) COMBINED FINANCIAL ADMINISTRATION. Notwithstanding subsection (c), a State may (as a convenience and to avoid unnecessary administrative costs) combine, in accordance with State law, the financial administration of a State loan fund established under this section with the financial administration of any other revolving fund established by the State if otherwise not prohibited by the law under which the State loan fund was established and if the Administrator determines that (A) the grants under this section, together with loan repayments and interest, will be separately accounted for and used solely for the purposes specified in subsection (a); and (B) the authority to establish assistance priorities and carry out oversight and related activities (other than financial administration) with respect to assistance remains with the State agency having primary responsibility for administration of the State program under Section 1413, after consultation with other appropriate State agencies (as determined by the State) provided, that in nonprimacy States eligible to receive assistance under this section, the Governor shall determine which State agency will have authority to establish priorities for financial assistance from the State loan fund. (2) COST OF ADMINISTERING FUND. Each State may annually use up to 4 percent of the funds allotted to the State under this section to cover the reasonable costs of administration of the programs under this section, including the recovery of reasonable costs expended to establish a State loan fund that are incurred after the date of enactment of this section, and to provide technical assistance to public water systems within the State. For fiscal year 1995 and each fiscal year thereafter, each

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State may use up to an additional 10 percent of the funds allotted to the State under this section (A) for public water system supervision programs under Section 1443(a); (B) to administer or provide technical assistance through source water protection programs; (C) to develop and implement a capacity development strategy under Section 1420(c); and (D) for an operator certification program for purposes of meeting the requirements of Section 1419, if the State matches the expenditures with at least an equal amount of State funds. At least half of the match must be additional to the amount expended by the State for public water supervision in fiscal year 1993. An additional 2 percent of the funds annually allotted to each State under this section may be used by the State to provide technical assistance to public water systems serving 10,000 or fewer persons in the State. Funds utilized under subparagraph (B) shall not be used for enforcement actions. (3) GUIDANCE AND REGULATIONS. The Administrator shall publish guidance and promulgate regulations as may be necessary to carry out the provisions of this section, including (A) provisions to ensure that each State commits and expends funds allotted to the State under this section as efficiently as possible in accordance with this title and applicable State laws; (B) guidance to prevent waste, fraud, and abuse; and (C) guidance to avoid the use of funds made available under this section to finance the expansion of any public water system in anticipation of future population growth. The guidance and regulations shall also ensure that the States, and public water systems receiving assistance under this section, use accounting, audit, and fiscal procedures that conform to generally accepted accounting standards. (4) STATE REPORT. Each State administering a loan fund and assistance program under this subsection shall publish and submit to the Administrator a report every 2 years on its activities under this section, including the findings of the most recent audit of the fund and the entire State allotment. The Administrator shall periodically audit all State loan funds established by, and all other amounts allotted to, the States pursuant to this section in accordance with procedures established by the Comptroller General. (h) NEEDS SURVEY. The Administrator shall conduct an assessment of water system capital improvement needs of all eligible public water systems in the United States and submit a report to the Congress containing the results of the assessment within 180 days after the date of enactment of the Safe Drinking Water Act Amendments of 1996 and every 4 years thereafter. (i) INDIAN TRIBES (1) IN GENERAL. One and one-half (1.5%) of the amounts appropriated annually to carry out this section may be used by the Administrator to make grants to Indian Tribes and Alaska Native villages that have not otherwise received

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either grants from the Administrator under this section or assistance from State loan funds established under this section. The grants may only be used for expenditures by tribes and villages for public water system expenditures referred to in subsection (a)(2). (2) USE OF FUNDS. Funds reserved pursuant to paragraph (1) shall be used to address the most significant threats to public health associated with public water systems that serve Indian Tribes, as determined by the Administrator in consultation with the Director of the Indian Health Service and Indian Tribes. (3) ALASKA NATIVE VILLAGES. In the case of a grant for a project under this subsection in an Alaska Native village, the Administrator is also authorized to make grants to the State of Alaska for the benefit of Native villages. An amount not to exceed 4 percent of the grant amount may be used by the State of Alaska for project management. (4) NEEDS ASSESSMENT. The Administrator, in consultation with the Director of the Indian Health Service and Indian Tribes, shall, in accordance with a schedule that is consistent with the needs surveys conducted pursuant to subsection (h), prepare surveys and assess the needs of drinking water treatment facilities to serve Indian Tribes, including an evaluation of the public water systems that pose the most significant threats to public health. (j) OTHER AREAS. Of the funds annually available under this section for grants to States, the Administrator shall make allotments in accordance with Section 1443(a)(4) for the Virgin Islands, the Commonwealth of the Northern Mariana Islands, American Samoa, and Guam. The grants allotted as provided in this subsection may be provided by the Administrator to the governments of such areas, to public water systems in such areas, or to both, to be used for the public water system expenditures referred to in subsection (a)(2). The grants, and grants for the District of Columbia, shall not be deposited in State loan funds. The total allotment of grants under this section for all areas described in this subsection in any fiscal year shall not exceed 0.33 percent of the aggregate amount made available to carry out this section in that fiscal year. (k) OTHER AUTHORIZED ACTIVITIES (1) IN GENERAL. Notwithstanding subsection (a)(2), a State may take each of the following actions: (A) Provide assistance, only in the form of a loan, to one or more of the following: (i) Any public water system described in subsection (a)(2) to acquire land or a conservation easement from a willing seller or grantor, if the purpose of the acquisition is to protect the source water of the system from contamination and to ensure compliance with national primary drinking water regulations. (ii) Any community water system to implement local, voluntary source water protection measures to protect source water in areas delineated pursuant to Section 1453, in order to facilitate compliance with national primary drinking water regulations applicable to the system under Section 1412 or otherwise significantly further the health protection objectives of this title. Funds authorized under this clause may be used to fund only voluntary, incentive-based mechanisms.

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(iii) Any community water system to provide funding in accordance with Section 1454(a)(1)(B)(i). (B) Provide assistance, including technical and financial assistance, to any public water system as part of a capacity development strategy developed and implemented in accordance with Section 1420(c). (C) Make expenditures from the capitalization grant of the State for fiscal years 1996 and 1997 to delineate and assess source water protection areas in accordance with Section 1453, except that funds set aside for such expenditure shall be obligated within 4 fiscal years. (D) Make expenditures from the fund for the establishment and implementation of wellhead protection programs under Section 1428. (2) LIMITATION. For each fiscal year, the total amount of assistance provided and expenditures made by a State under this subsection may not exceed 15 percent of the amount of the capitalization grant received by the State for that year and may not exceed 10 percent of that amount for any one of the following activities: (A) To acquire land or conservation easements pursuant to paragraph (1)(A)(i). (B) To provide funding to implement voluntary, incentive-based source water quality protection measures pursuant to clauses (ii) and (iii) of paragraph (1)(A). (C) To provide assistance through a capacity development strategy pursuant to paragraph (1)(B). (D) To make expenditures to delineate or assess source water protection areas pursuant to paragraph (1)(C). (E) To make expenditures to establish and implement wellhead protection programs pursuant to paragraph (1)(D). (3) STATUTORY CONSTRUCTION. Nothing in this section creates or conveys any new authority to a State, political subdivision of a State, or community water system for any new regulatory measure, or limits any authority of a State, political subdivision of a State, or community water system. (l) SAVINGS. The failure or inability of any public water system to receive funds under this section or any other loan or grant program, or any delay in obtaining the funds, shall not alter the obligation of the system to comply in a timely manner with all applicable drinking water standards and requirements of this title. (m) AUTHORIZATION OF APPROPRIATIONS. There are authorized to be appropriated to carry out the purposes of this section $599,000,000 for the fiscal year 1994 and $1,000,000,000 for each of the fiscal years 1995 through 2003. To the extent amounts authorized to be appropriated under this subsection in any fiscal year are not appropriated in that fiscal year, such amounts are authorized to be appropriated in a subsequent fiscal year (prior to the fiscal year 2004). Such sums shall remain available until expended. (n) HEALTH EFFECTS STUDIES. From funds appropriated pursuant to this section for each fiscal year, the Administrator shall reserve $10,000,000 for health effects studies on drinking water contaminants authorized by the Safe Drinking Water Act Amendments of 1996. In allocating funds made available under this subsection, the Administrator shall give priority to studies concerning the health effects of cryptosporidium [as authorized by Sect. 1458(c)], disinfection byproducts

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[as authorized by Sect. 1458(c)], and arsenic [as authorized by Sect. 1412(b)(12)(A)], and the implementation of a plan for studies of subpopulations at greater risk of adverse effects [as authorized by Sect. 1458(a)]. (o) MONITORING FOR UNREGULATED CONTAMINANTS. From funds appropriated pursuant to this section for each fiscal year beginning with fiscal year 1998, the Administrator shall reserve $2,000,000 to pay the costs of monitoring for unregulated contaminants under Section 1445(a)(2)(C). (p) DEMONSTRATION PROJECT FOR STATE OF VIRGINIA. Notwithstanding the other provisions of this section limiting the use of funds deposited in a State loan fund from any State allotment, the State of Virginia may, as a single demonstration and with the approval of the Virginia General Assembly and the Administrator, conduct a program to demonstrate alternative approaches to intergovernmental coordination to assist in the financing of new drinking water facilities in the following rural communities in southwestern Virginia where none exists on the date of enactment of the Safe Drinking Water Act Amendments of 1996 and where such communities are experiencing economic hardship: Lee County, Wise County, Scott County, Dickenson County, Russell County, Buchanan County, Tazewell County, and the city of Norton, Virginia. The funds allotted to that State and deposited in the State loan fund may be loaned to a regional endowment fund for the purpose set forth in this subsection under a plan to be approved by the Administrator. The plan may include an advisory group that includes representatives of such counties. (q) SMALL SYSTEM TECHNICAL ASSISTANCE. The Administrator may reserve up to 2 percent of the total funds appropriated pursuant to subsection (m) for each of the fiscal years 1997 through 2003 to carry out the provisions of Section 1442(e) (relating to technical assistance for small systems), except that the total amount of funds made available for such purpose in any fiscal year through appropriations [as authorized by Sect. 1442(e)] and reservations made pursuant to this subsection shall not exceed the amount authorized by Section 1442(e). (r) EVALUATION. The Administrator shall conduct an evaluation of the effectiveness of the State loan funds through fiscal year 2001. The evaluation shall be submitted to Congress at the same time as the President submits to the Congress, pursuant to Section 1108 of Title 31, United States Code, an appropriations request for fiscal year 2003 relating to the budget of the U.S. Environmental Protection Agency.

SOURCE WATER QUALITY ASSESSMENT 42 USC 300j-13 SECTION 1453. (a) SOURCE WATER ASSESSMENT (1) GUIDANCE. Within 12 months after the date of enactment of the Safe Drinking Water Act Amendments of 1996, after notice and comment, the Administrator shall publish guidance for States exercising primary enforcement responsibility for public water systems to carry out directly or through delegation (for the

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protection and benefit of public water systems and for the support of monitoring flexibility) a source water assessment program within the State’s boundaries. Each State adopting modifications to monitoring requirements pursuant to Section 1418(b) shall, prior to adopting such modifications, have an approved source water assessment program under this section and shall carry out the program either directly or through delegation. (2) PROGRAM REQUIREMENTS. A source water assessment program under this subsection shall (A) delineate the boundaries of the assessment areas in such State from which one or more public water systems in the State receive supplies of drinking water, using all reasonably available hydrogeologic information on the sources of the supply of drinking water in the State and the water flow, recharge, and discharge and any other reliable information as the State deems necessary to adequately determine such areas; and (B) identify for contaminants regulated under this title for which monitoring is required under this title (or any unregulated contaminants selected by the State, in its discretion, which the State, for the purposes of this subsection, has determined may present a threat to public health), to the extent practical, the origins within each delineated area of such contaminants to determine the susceptibility of the public water systems in the delineated area to such contaminants. (3) APPROVAL, IMPLEMENTATION, AND MONITORING RELIEF. A State source water assessment program under this subsection shall be submitted to the Administrator within 18 months after the Administrator’s guidance is issued under this subsection and shall be deemed approved 9 months after the date of such submittal unless the Administrator disapproves the program as provided in Section 1428(c). States shall begin implementation of the program immediately after its approval. The Administrator’s approval of a State program under this subsection shall include a timetable, established in consultation with the State, allowing not more than 2 years for completion after approval of the program. Public water systems seeking monitoring relief in addition to the interim relief provided under Section 1418(a) shall be eligible for monitoring relief, consistent with Section 1418(b), upon completion of the assessment in the delineated source water assessment area or areas concerned. (4) TIMETABLE. The timetable referred to in paragraph (3) shall take into consideration the availability to the State of funds under Section 1452 (relating to State loan funds) for assessments and other relevant factors. The Administrator may extend any timetable included in a State program approved under paragraph (3) to extend the period for completion by an additional 18 months. (5) DEMONSTRATION PROJECT. The Administrator shall, as soon as practicable, conduct a demonstration project, in consultation with other Federal agencies, to demonstrate the most effective and protective means of assessing and protecting source waters serving large metropolitan areas and located on Federal lands. (6) USE OF OTHER PROGRAMS. To avoid duplication and to encourage efficiency, the program under this section may make use of any of the following: (A) Vulnerability assessments, sanitary surveys, and monitoring programs.

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(B) Delineations or assessments of groundwater sources under a State wellhead protection program developed pursuant to this section. (C) Delineations or assessments of surface or groundwater sources under a State pesticide management plan developed pursuant to the Pesticide and Ground Water State Management Plan Regulation (subparts I and J of Part 152 of Title 40, Code of Federal Regulations), promulgated under section 3(d) of the Federal Insecticide, Fungicide, and Rodenticide Act [7 USC 136a(d)]. (D) Delineations or assessments of surface water sources under a State watershed initiative or to satisfy the watershed criterion for determining if filtration is required under the Surface Water Treatment Rule (Sect. 141.70 of Title 40, Code of Federal Regulations). (E) Delineations or assessments of surface or groundwater sources under programs or plans pursuant to the Federal Water Pollution Control Act. (7) PUBLIC AVAILABILITY. The State shall make the results of the source water assessments conducted under this subsection available to the public. (b) APPROVAL AND DISAPPROVAL. For provisions relating to program approval and disapproval, see Section 1428(c).

SOURCE WATER PETITION PROGRAM 42 USC 300j-14 SECTION 1454. (a) PETITION PROGRAM (1) IN GENERAL (A) ESTABLISHMENT. A State may establish a program under which an owner or operator of a community water system in the State, or a municipal or local government or political subdivision of a State, may submit a source water quality protection partnership petition to the State requesting that the State assist in the local development of a voluntary, incentive-based partnership, among the owner, operator, or government and other persons likely to be affected by the recommendations of the partnership, to (i) reduce the presence in drinking water of contaminants that may be addressed by a petition by considering the origins of the contaminants, including to the maximum extent practicable the specific activities that affect the drinking water supply of a community; (ii) obtain financial or technical assistance necessary to facilitate establishment of a partnership, or to develop and implement recommendations of a partnership for the protection of source water to assist in the provision of drinking water that complies with national primary drinking water regulations with respect to contaminants addressed by a petition; and (iii) develop recommendations regarding voluntary and incentive-based strategies for the long-term protection of the source water of community water systems. (B) FUNDING. Each State may

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(i) use funds set aside pursuant to Section 1452(k)(1)(A)(iii) by the State to carry out a program described in subparagraph (A), including assistance to voluntary local partnerships for the development and implementation of partnership recommendations for the protection of source water such as source water quality assessment, contingency plans, and demonstration projects for partners within a source water area delineated under Section 1453(a); and (ii) provide assistance in response to a petition submitted under this subsection using funds referred to in subsection (b)(2)(B). (2) OBJECTIVES. The objectives of a petition submitted under this subsection shall be to (A) facilitate the local development of voluntary, incentive-based partnerships among owners and operators of community water systems, governments, and other persons in source water areas; and (B) obtain assistance from the State in identifying resources which are available to implement the recommendations of the partnerships to address the origins of drinking water contaminants that may be addressed by a petition (including to the maximum extent practicable the specific activities contributing to the presence of the contaminants) that affect the drinking water supply of a community. (3) CONTAMINANTS ADDRESSED BY A PETITION. A petition submitted to a State under this subsection may address only those contaminants (A) that are pathogenic organisms for which a national primary drinking water regulation has been established or is required under Section 1412; or (B) for which a national primary drinking water regulation has been promulgated or proposed and that are detected by adequate monitoring methods in the source water at the intake structure or in any collection, treatment, storage, or distribution facilities by the community water systems at levels (i) above the maximum contaminant level; or (ii) that are not reliably and consistently below the maximum contaminant level. (4) CONTENTS. A petition submitted under this subsection shall, at a minimum (A) include a delineation of the source water area in the State that is the subject of the petition; (B) identify, to the maximum extent practicable, the origins of the drinking water contaminants that may be addressed by a petition (including to the maximum extent practicable the specific activities contributing to the presence of the contaminants) in the source water area delineated under Section 1453; (C) identify any deficiencies in information that will impair the development of recommendations by the voluntary local partnership to address drinking water contaminants that may be addressed by a petition; (D) specify the efforts made to establish the voluntary local partnership and obtain the participation of (i) the municipal or local government or other political subdivision of the State with jurisdiction over the source water area delineated under Section 1453; and (ii) each person in the source water area delineated under Section 1453 (I) who is likely to be affected by recommendations of the voluntary local partnership; and

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(II) whose participation is essential to the success of the partnership; (E) outline how the voluntary local partnership has or will, during development and implementation of recommendations of the voluntary local partnership, identify, recognize and take into account any voluntary or other activities already being undertaken by persons in the source water area delineated under Section 1453 under Federal or State law to reduce the likelihood that contaminants will occur in drinking water at levels of public health concern; and (F) specify the technical, financial, or other assistance that the voluntary local partnership requests of the State to develop the partnership or to implement recommendations of the partnership. (b) APPROVAL OR DISAPPROVAL OF PETITIONS (1) IN GENERAL. After providing notice and an opportunity for public comment on a petition submitted under subsection (a), the State shall approve or disapprove the petition, in whole or in part, not later than 120 days after the date of submission of the petition. (2) APPROVAL. The State may approve a petition if the petition meets the requirements established under subsection (a). The notice of approval shall, at a minimum, include for informational purposes (A) an identification of technical, financial, or other assistance that the State will provide to assist in addressing the drinking water contaminants that may be addressed by a petition based on (i) the relative priority of the public health concern identified in the petition with respect to the other water quality needs identified by the State; (ii) any necessary coordination that the State will perform of the program established under this section with programs implemented or planned by other States under this section; and (iii) funds available [including funds available from a State revolving loan fund established under Title VI of the Federal Water Pollution Control Act (33 USC 1381 et seq.)] or Section 1452; (B) a description of technical or financial assistance pursuant to Federal and State programs that is available to assist in implementing recommendations of the partnership in the petition, including (i) any program established under the Federal Water Pollution Control Act (33 USC 1251 et seq.); (ii) the program established under Section 6217 of the Coastal Zone Act Reauthorization Amendments of 1990 (16 USC 1455b); (iii) the agricultural water quality protection program established under Chapter 2 of Subtitle D of Title XII of the Food Security Act of 1985 (16 USC 3838 et seq.); (iv) the sole-source aquifer protection program established under Section 1427; (v) the community wellhead protection program established under Section 1428; (vi) any pesticide or groundwater management plan; (vii) any volunteer agricultural resource management plan or voluntary wholefarm or whole-ranch management plan developed and implemented under a process established by the Secretary of Agriculture; and (viii) any abandoned well closure program; and

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(C) a description of activities that will be undertaken to coordinate Federal and State programs to respond to the petition. (3) DISAPPROVAL. If the State disapproves a petition submitted under subsection (a), the State shall notify the entity submitting the petition in writing of the reasons for disapproval. A petition may be resubmitted at any time if (A) new information becomes available; (B) conditions affecting the source water that is the subject of the petition change; or (C) modifications are made in the type of assistance being requested. (c) GRANTS TO SUPPORT STATE PROGRAMS (1) IN GENERAL. The Administrator may make a grant to each State that establishes a program under this section that is approved under paragraph (2). The amount of each grant shall not exceed 50 percent of the cost of administering the program for the year in which the grant is available. (2) APPROVAL. In order to receive grant assistance under this subsection, a State shall submit to the Administrator for approval a plan for a source water quality protection partnership program that is consistent with the guidance published under subsection (d). The Administrator shall approve the plan if the plan is consistent with the guidance published under subsection (d). (d) GUIDANCE (1) IN GENERAL. Not later than 1 year after the date of enactment of this section, the Administrator, in consultation with the States, shall publish guidance to assist (A) States in the development of a source water quality protection partnership program; and (B) municipal or local governments or political subdivisions of a State and community water systems in the development of source water quality protection partnerships and in the assessment of source water quality. (2) CONTENTS OF THE GUIDANCE. The guidance shall, at a minimum (A) recommend procedures for the approval or disapproval by a State of a petition submitted under subsection (a); (B) recommend procedures for the submission of petitions developed under subsection (a); (C) recommend criteria for the assessment of source water areas within a State; and (D) describe technical or financial assistance pursuant to Federal and State programs that is available to address the contamination of sources of drinking water and to develop and respond to petitions submitted under subsection (a). (e) AUTHORIZATION OF APPROPRIATIONS. There are authorized to be appropriated to carry out this section $5,000,000 for each of the fiscal years 1997 through 2003. Each State with a plan for a program approved under subsection (b) shall receive an equitable portion of the funds available for any fiscal year. (f) STATUTORY CONSTRUCTION. Nothing in this section (1)(A) creates or conveys new authority to a State, political subdivision of a State, or community water system for any new regulatory measure; or

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(B) limits any authority of a State, political subdivision, or community water system; or (2) precludes a community water system, municipal or local government, or political subdivision of a government from locally developing and carrying out a voluntary, incentive-based, source water quality protection partnership to address the origins of drinking water contaminants of public health concern.

WATER CONSERVATION PLAN 42 USC 300j-15 SECTION 1455. (a) GUIDELINES. Not later than 2 years after the date of enactment of the Safe Drinking Water Act Amendments of 1996, the Administrator shall publish in the Federal Register guidelines for water conservation plans for public water systems serving fewer than 3300 persons, public water systems serving between 3300 and 10,000 persons, and public water systems serving more than 10,000 persons, taking into consideration such factors as water availability and climate. (b) LOANS OR GRANTS. Within 1 year after publication of the guidelines under subsection (a), a State exercising primary enforcement responsibility for public water systems may require a public water system, as a condition of receiving a loan or grant from a State loan fund under Section 1452, to submit with its application for such loan or grant a water conservation plan consistent with such guidelines.

ASSISTANCE TO COLONIAS 42 USC 300j-16 SECTION 1456. (a) DEFINITIONS. As used in this section (1) BORDER STATE. The term ‘‘border State’’ means Arizona, California, New Mexico, and Texas. (2) ELIGIBLE COMMUNITY. The term ‘‘eligible community’’ means a lowincome community with economic hardship that (A) is commonly referred to as a colonia; (B) is located along the United States–Mexico border (generally in an unincorporated area); and (C) lacks a safe drinking water supply or adequate facilities for the provision of safe drinking water for human consumption. (b) GRANTS TO ALLEVIATE HEALTH RISKS. The Administrator of the U.S. Environmental Protection Agency and the heads of other appropriate Federal agencies are authorized to award grants to a border State to provide assistance to eligible communities to facilitate compliance with national primary drinking water regulations or otherwise significantly further the health protection objectives of this title.

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(c) USE OF FUNDS. Each grant awarded pursuant to subsection (b) shall be used to provide assistance to one or more eligible communities with respect to which the residents are subject to a significant health risk (as determined by the Administrator or the head of the Federal agency making the grant) attributable to the lack of access to an adequate and affordable drinking water supply system. (d) COST SHARING. The amount of a grant awarded pursuant to this section shall not exceed 50 percent of the costs of carrying out the project that is the subject of the grant. (e) AUTHORIZATION OF APPROPRIATIONS. There are authorized to be appropriated to carry out this section $25,000,000 for each of the fiscal years 1997 through 1999. ESTROGENIC SUBSTANCES SCREENING PROGRAM 42 USC 300j-17 SECTION 1457. In addition to the substances referred to in Section 408(p)(3)(B) of the Federal Food, Drug, and Cosmetic Act [21 USC 346a(p)(3)(B)], the Administrator may provide for testing under the screening program authorized by Section 408(p) of such Act, in accordance with the provisions of Section 408(p) of such Act, of any other substance that may be found in sources of drinking water if the Administrator determines that a substantial population may be exposed to such substance. DRINKING WATER STUDIES 42 USC 300j-18 SECTION 1458. (a) SUBPOPULATIONS AT GREATER RISK (1) IN GENERAL. The Administrator shall conduct a continuing program of studies to identify groups within the general population that may be at greater risk than the general population of adverse health effects from exposure to contaminants in drinking water. The study shall examine whether and to what degree infants, children, pregnant women, the elderly, individuals with a history of serious illness, or other subpopulations that can be identified and characterized are likely to experience elevated health risks, including risks of cancer, from contaminants in drinking water. (2) REPORT. Not later than 4 years after the date of enactment of this subsection and periodically thereafter as new and significant information becomes available, the Administrator shall report to the Congress on the results of the studies. (b) BIOLOGICAL MECHANISMS. The Administrator shall conduct biomedical studies to (1) understand the mechanisms by which chemical contaminants are absorbed, distributed, metabolized, and eliminated from the human body, so as to develop more accurate physiologically based models of the phenomena;

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(2) understand the effects of contaminants and the mechanisms by which the contaminants cause adverse effects (especially noncancer and infectious effects) and the variations in the effects among humans, especially subpopulations at greater risk of adverse effects, and between test animals and humans; and (3) develop new approaches to the study of complex mixtures, such as mixtures found in drinking water, especially to determine the prospects for synergistic or antagonistic interactions that may affect the shape of the dose–response relationship of the individual chemicals and microbes, and to examine noncancer endpoints and infectious diseases, and susceptible individuals and subpopulations. (c) STUDIES ON HARMFUL SUBSTANCES IN DRINKING WATER (1) DEVELOPMENT OF STUDIES. The Administrator shall, not later than 180 days after the date of enactment of this section and after consultation with the Secretary of Health and Human Services, the Secretary of Agriculture, and, as appropriate, the heads of other Federal agencies, conduct the studies described in paragraph (2) to support the development and implementation of the most current version of each of the following: (A) Enhanced Surface Water Treatment Rule [Fed. Reg. 59:38832 (July 29, 1994)]. (B) Disinfectant and Disinfection Byproducts Rule [Fed. Reg. 59:38668 (July 29, 1994)]. (C) Ground Water Disinfection Rule (availability of draft summary announced at [Fed. Reg. 57:33960; July 31, 1992)]. (2) CONTENTS OF STUDIES. The studies required by paragraph (1) shall include, at a minimum, each of the following: (A) Toxicological studies and, if warranted, epidemiologic studies to determine what levels of exposure from disinfectants and disinfection byproducts, if any, may be associated with developmental and birth defects and other potential toxic end points. (B) Toxicological studies and, if warranted, epidemiologic studies to quantify the carcinogenic potential from exposure to disinfection byproducts resulting from different disinfectants. (C) The development of dose–response curves for pathogens, including cryptosporidium and the Norwalk virus. (3) AUTHORIZATION OF APPROPRIATIONS. There are authorized to be appropriated to carry out this subsection $12,500,000 for each of fiscal years 1997 through 2003. (d) WATERBORNE DISEASE OCCURRENCE STUDY (1) SYSTEM. The Director of the Centers for Disease Control and Prevention, and the Administrator shall jointly (A) within 2 years after the date of enactment of this section, conduct pilot waterborne disease occurrence studies for at least 5 major United States communities or public water systems; and (B) within 5 years after the date of enactment of this section, prepare a report on the findings of the pilot studies, and a national estimate of waterborne disease occurrence.

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(2) TRAINING AND EDUCATION. The Director and Administrator shall jointly establish a national health care provider training and public education campaign to inform both the professional healthcare provider community and the general public about waterborne disease and the symptoms that may be caused by infectious agents, including microbial contaminants. In developing such a campaign, they shall seek comment from interested groups and individuals, including scientists, physicians, State and local governments, environmental groups, public water systems, and vulnerable populations. (3) FUNDING. There are authorized to be appropriated for each of the fiscal years 1997 through 2001, $3,000,000 to carry out this subsection. To the extent funds under this subsection are not fully appropriated, the Administrator may use not more than $2,000,000 of the funds from amounts reserved under Section 1452(n) for health effects studies for purposes of this subsection. The Administrator may transfer a portion of such funds to the Centers for Disease Control and Prevention for such purposes.

Part F—Additional Requirements to Regulate the Safety of Drinking Water DEFINITIONS 42 USC 300j-21 SECTION 1461. As used in this part (1) Drinking water cooler. The term ‘‘drinking water cooler’’ means any mechanical device affixed to drinking water supply plumbing which actively cools water for human consumption. (2) Lead-free. The term ‘‘lead-free’’ means, with respect to a drinking water cooler, that each part of component of the cooler which may come in contact with drinking water contains not more than 8 percent lead, except that no drinking water cooler which contains any solder, flux, or storage tank interior surface which may come in contact with drinking water shall be considered lead-free if the solder, flux, or storage tank interior surface contains more than 0.2 percent lead. The Administrator may establish more stringent requirements for treating any part or component of a drinking water cooler as lead-free for purposes of this part whenever he determines that any such part may constitute an important source of lead in drinking water. (3) Local educational agency. The term ‘‘local educational agency’’ means (A) any local educational agency as defined in Section 198 of the Elementary and Secondary Education Act of 1965 (20 USC 3381), (B) the owner of any private, nonprofit elementary or secondary school building, and (C) the governing authority of any school operating under the defense dependent’s education system provided for under the Defense Dependent’s Education Act of 1978 (20 USC 921 et seq.).

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(4) Repair. The term ‘‘repair’’ means, with respect to a drinking water cooler, to take such corrective action as is necessary to ensure that water cooler is lead-free. (5) Replacement. The term ‘‘replacement,’’ when used with respect to a drinking water cooler, means the permanent removal of the water cooler and the installation of a lead-free water cooler. (6) School. The term ‘‘school’’ means any elementary school or secondary school as defined in Section 198 of the Elementary and Secondary Education Act of 1965 (20 USC 2854) and any kindergarten or daycare facility. (7) Lead-lined tank. The term ‘‘lead-lined tank’’ means a water reservoir container in a drinking water cooler constructed of lead or that has an interior surface that is not lead-free.

RECALL OF DRINKING WATER COOLERS WITH LEAD-LINED TANKS 42 USC 300j-22 SECTION 1462. For purposes of the Consumer Product Safety Act, all drinking water coolers identified by the Administrator on the list under Section 1463 as having a lead-lined tank shall be considered to be imminently hazardous consumer products within the meaning of Section 12 of such Act (15 USC 2061). After notice and opportunity for comment, including a public hearing, the Consumer Product Safety Commission shall issue an order requiring the manufacturers and importers of such coolers to repair, replace, or recall and provide a refund for such coolers within 1 year after the enactment of the Lead Contamination Control Act of 1988. For purpose of enforcement, such order shall be treated as an order under Section 15(d) of that Act [15 USC 2064(d)].

DRINKING WATER COOLERS CONTAINING LEAD 42 USC 300j-23 SECTION 1463. (a) PUBLICATION OF LISTS. The Administrator shall, after notice and opportunity for public comment, identify each brand and model of drinking water cooler which is not lead-free, including each brand and model of drinking water cooler which has a lead-lined tank. For purposes of identifying the brand and model of drinking water coolers under this subsection, the Administrator shall use the best information available to the U.S. Environmental Protection Agency. Within 100 days after the enactment of this section, the Administrator shall publish a list of each brand and model of drinking water cooler identified under this subsection. Such list shall separately identify each brand and model of cooler which has a lead-lined tank. The Administrator shall continue to gather information regarding lead in drinking water coolers and shall revise and republish the list from

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time to time as may be appropriate as new information or analysis becomes available regarding lead contamination in drinking water coolers. (b) PROHIBITION. No person may sell in interstate commerce, or manufacture for sale in interstate commerce, any drinking water cooler listed under subsection (a) or any other drinking water cooler which is not lead-free, including a lead-lined drinking water cooler. (c) CRIMINAL PENALTY. Any person who knowingly violates the prohibition contained in subsection (b) shall be imprisoned for not more than 5 years, or fined in accordance with Title 18 of the United States Code, or both. (d) CIVIL PENALTY. The Administrator may bring a civil action in the appropriate United States District Court (as determined under the provisions of Title 28 of the United States Code) to impose a civil penalty on any person who violates subsection (b). In any such action the court may impose on such person a civil penalty of not more than $5000 ($50,000 in the case of second or subsequent violation).

LEAD CONTAMINATION IN SCHOOL DRINKING WATER 42 USC 300j-24 SECTION 1464. (a) DISTRIBUTION OF DRINKING WATER COOLER LIST. Within 100 days after the enactment of this section, the Administrator shall distribute to the States a list of each brand and model of drinking water cooler identified and listed by the Administrator under Section 1463(a). (b) GUIDANCE DOCUMENT AND TESTING PROTOCOL. The Administrator shall publish a guidance document and a testing protocol to assist schools in determining the source and degree of lead contamination in school drinking water supplies and in remedying such contamination. The guidance document shall also include guidelines for sample preservation. The guidance document shall include guidance to assist States, schools, and the general public in ascertaining the levels of lead contamination in drinking water coolers and in taking appropriate action to reduce or eliminate such contamination. The guidance document shall contain a testing protocol for the identification of drinking water coolers which contribute to lead contamination in drinking water. Such document and protocol may be revised, republished, and redistributed as the Administrator deems necessary. The Administrator shall distribute the guidance document and testing protocol to the States within 100 days after the enactment of this section. (c) DISSEMINATION TO SCHOOLS, ETC. Each State shall provide for the dissemination to local educational agencies, private nonprofit elementary or secondary schools and to daycare centers of the guidance document and testing protocol published under subsection (b), together with the list of drinking water coolers published under Section 1463(a). (d) REMEDIAL ACTION PROGRAM

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(1) TESTING AND REMEDYING LEAD CONTAMINATION. Within 9 months after the enactment of this section, each State shall establish a program, consistent with this section, to assist local educational agencies in testing for, and remedying, lead contamination in drinking water coolers and from other sources of lead contamination at schools under the jurisdiction of such agencies. (2) PUBLIC AVAILABILITY. A copy of the results of any testing under paragraph (1) shall be available in the administrative offices of the local educational agency for inspection by the public, including teachers, other school personnel, and parents. The local educational agency shall notify parent, teacher, and employee organizations of the availability of such testing results. (3) COOLERS. In the case of drinking water coolers, such program shall include measures for the reduction or elimination of lead contamination from those water coolers which are not lead-free and which are located in schools. Such measures shall be adequate to ensure that within 15 months after the enactment of this subsection all such water coolers in schools under the jurisdiction of such agencies are repaired, replaced, permanently removed, or rendered inoperable unless the cooler is tested and found (within the limits of testing accuracy) not to contribute lead in drinking water.

FEDERAL ASSISTANCE FOR STATE PROGRAMS REGARDING LEAD CONTAMINATION IN SCHOOL DRINKING WATER 42 USC 300j-25 SECTION 1465. (a) SCHOOL DRINKING WATER PROGRAMS. The Administrator shall make grants to States to establish and carry out State programs under Section 1464 to assist local educational agencies in testing for, and remedying, lead contamination in drinking water from drinking water coolers and from other sources of lead contamination at schools under the jurisdiction of such agencies. Such grants may be used by States to reimburse local educational agencies for expenses incurred after the enactment of this section for such testing and remedial action. (b) LIMITS. Each grant under this section shall be used by the State for testing water coolers in accordance with Section 1464, for testing for lead contamination in other drinking water supplies under Section 1464, or for remedial action under State programs under Section 1464. Not more than 5 percent of the grant may be used for program administration. (c) AUTHORIZATION OF APPROPRIATIONS. There are authorized to be appropriated to carry out this section not more than $30,000,000 for fiscal year 1989, $30,000,000 for fiscal year 1990, and $30,000,000 for fiscal year 1991.

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PROVISIONS THAT DO NOT AMEND THE SDWA From Public Law 100-572, Oct. 31, 1988

CERTIFICATION OF TESTING LABORATORIES 42 USC 300J-26 SECTION 4. The Administrator of the U.S. Environmental Protection Agency shall assure that programs for the certification of testing laboratories which test drinking water supplies for lead contamination certify only those laboratories which provide reliable accurate testing. The Administrator (or the State in the case of a State to which certification authority is delegated under this subsection) shall publish and make available to the public upon request the list of laboratories certified under this subsection. From Public Law 102-389, Oct. 6, 1992 SECTION 519. (a) Safe Drinking Water Act Report. The Administrator of the U.S. Environmental Protection Agency shall report to Congress within nine months of the date of enactment of this section recommendations concerning the reauthorization of the Safe Drinking Water Act. Such report shall address (1) the adverse health effects associated with contaminants in drinking water and the public health and other benefits that may be realized by removing such contaminants; (2) the process for identifying contaminants in drinking water and selecting contaminants for control; (3) schedules for the development of regulations and compliance with drinking water standards; (4) the financial and technical capacity of drinking water systems to implement monitoring requirements associated with regulated and unregulated contaminants and options to facilitate implementation of such requirements, with special emphasis on small communities; (5) the financial and technical capacity of drinking water systems to install treatment facilities needed to assure compliance with drinking water standards and options to facilitate compliance with such standards, with special emphasis on small communities; (6) the financial and technical capacity of States to implement the drinking water program, including options for increasing funding of State programs; and (7) innovative and alternative methods to increase the financial and technical capacity of drinking water systems and the States to assure effective implementation of such Act. (b) Moratorium and Report on Radionuclides in Drinking Water. (1) The Administrator of the U.S. Environmental Protection Agency shall conduct a risk assessment

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of radon considering: (A) the risk of adverse human health effects associated with exposure to various pathways of radon; (B) the costs of controlling or mitigating exposure to radon; and (C) the costs for radon control or mitigation experienced by small communities as the result of such regulation. Such an evaluation shall consider the risks posed by the treatment or disposal of any wastes produced by water treatment. The Science Advisory Board shall review the Agency’s study and submit a recommendation to the Administrator on its findings. The Administrator shall report the Administrator’s findings and the Science Advisory Board recommendations to the Senate Committe on Environment and Public Works and the House Committee on Energy and Commerce. Not later than July 31, 1993, the Administrator shall publish the Administrator’s study and risk assessment and the Science Advisory Board recommendation. (2) The Administrator is directed, if additional time is required to establish the radon standard, to seek an extension of the deadline contained in the judicially imposed consent decree for promulgation of the radon standard to a date not later than October 1, 1993. (c) Small System Monitoring Cost Reduction. With respect to monitoring requirements for organic chemicals, pesticides, PCBs, or unregulated contaminants promulgated in January 1991 (known as the Phase II rule), the Administrator or a primacy State may modify such requirements to provide that any drinking water system serving a population of less than 3300 persons shall not be required to conduct additional quarterly monitoring for a specific contaminant or contaminants prior to October 1, 1993, if monitoring for any one quarter conducted after the date of enactment of this subsection and prior to October 1, 1993 for any such contaminant or contaminants in the water supplied by the drinking water system. From Public Law 104-182, Aug. 6, 1996 SECTION 2. REFERENCES; EFFECTIVE DATE; DISCLAIMER (c) DISCLAIMER. Except for the provisions of Section 302 (relating to transfers of funds), nothing in this Act or in any amendments made by this Act to Title XIV of the Public Health Service Act (commonly known as the ‘‘Safe Drinking Water Act’’) or any other law shall be construed by the Administrator of the U.S. Environmental Protection Agency or the courts as affecting, modifying, expanding, changing, or altering (1) the provisions of the Federal Water Pollution Control Act; (2) the duties and responsibilities of the Administrator under that Act; or (3) the regulation or control of point or nonpoint sources of pollution discharged into waters covered by that Act. The Administrator shall identify in the agency’s annual budget all funding and full-time equivalents administering such Title XIV separately from funding and staffing for the Federal Water Pollution Control Act. SECTION 3. FINDINGS. The Congress finds that (1) safe drinking water is essential to the protection of public health;

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(2) because the requirements of the Safe Drinking Water Act (42 USC 300f et seq.) now exceed the financial and technical capacity of some public water systems, especially many small public water systems, the Federal Government needs to provide assistance to communities to help the communities meet Federal drinking water requirements; (3) the Federal Government commits to maintaining and improving its partnership with the States in the administration and implementation of the Safe Drinking Water Act; (4) States play a central role in the implementation of safe drinking water programs, and States need increased financial resources and appropriate flexibility to ensure the prompt and effective development and implementation of drinking water programs; (5) the existing process for the assessment and selection of additional drinking water contaminants needs to be revised and improved to ensure that there is a sound scientific basis for setting priorities in establishing drinking water regulations; (6) procedures for assessing the health effects of contaminants establishing drinking water standards should be revised to provide greater opportunity for public education and participation; (7) in considering the appropriate level of regulation for contaminants in drinking water, risk assessment, based on sound and objective science, and benefit–cost analysis are important analytical tools for improving the efficiency and effectiveness of drinking water regulations to protect human health; (8) more effective protection of public health requires (A) a Federal commitment to set priorities that will allow scarce Federal, State, and local resources to be targeted toward the drinking water problems of greatest public health concern; (B) maximizing the value of the different and complementary strengths and responsibilities of the Federal and State governments in those States that have primary enforcement responsibility for the Safe Drinking Water Act; and (C) prevention of drinking water contamination through well-trained system operators, water systems with adequate managerial, technical, and financial capacity, and enhanced protection of source waters of public water systems; (9) compliance with the requirements of the Safe Drinking Water Act continues to be a concern at public water systems experiencing technical and financial limitations, and Federal, State, and local governments need more resources and more effective authority to attain the objectives of the Safe Drinking Water Act; and (10) consumers served by public water systems should be provided with information on the source of the water they are drinking and its quality and safety, as well as prompt notification of any violation of drinking water regulations. TITLE I—AMENDMENTS TO SAFE DRINKING WATER ACT SECTION 101. DEFINITIONS (b) PUBLIC WATER SYSTEM (2) GAO STUDY. The Comptroller General of the United States shall undertake a study to

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(A) ascertain the numbers and locations of individuals and households relying for their residential water needs, including drinking, bathing, and cooking (or other similar uses) on irrigation water systems, mining water systems, industrial water systems, or other water systems covered by Section 1401(4)(B) of the Safe Drinking Water Act that are not public water systems subject to the Safe Drinking Water Act; (B) determine the sources and costs and affordability (to users and systems) of water used by such populations for their residential water needs; and (C) review State and water system compliance with the exclusion provisions of Section 1401(4)(B) of such Act. The Comptroller General shall submit a report to the Congress within 3 years after the date of enactment of this Act containing the results of such study. SECTION 104. STANDARD-SETTING (b) DISINFECTANTS AND DISINFECTION BYPRODUCTS. The Administrator of the Environmental Protection Agency may use the authority of section 1412(b)(5) of the Safe Drinking Water Act (as amended by this Act) to promulgate the Stage I and Stage II Disinfectants and Disinfection Byproducts Rules as proposed in Volume 59, Federal Register, page 38668 (July 29, 1994). The considerations used in the development of the July 29, 1994, proposed national primary drinking water regulation on disinfectants and disinfection byproducts shall be treated as consistent with such Section 1412(b)(5) for purposes of such Stage I and Stage II rules. SECTION 114. PUBLIC NOTIFICATION (b) BOTTLED WATER STUDY. Not later than 18 months after the date of enactment of this Act, the Administrator of the Food and Drug Administration, in consultation with the Administrator of the Environmental Protection Agency, shall publish for public notice and comment a draft study on the feasibility of appropriate methods, if any, of informing customers of the contents of bottled water. The Administrator of the Food and Drug Administration shall publish a final study not later than 30 months after the date of enactment of this Act. SECTION 117. EXEMPTIONS (b) LIMITED ADDITIONAL COMPLIANCE PERIOD. (1) The State of New York, on a case-by-case basis and after notice and an opportunity of at least 60 days for public comment, may allow an additional period for compliance with the Surface Water Treatment Rule established pursuant to Section 1412(b)(7)(C) of the Safe Drinking Water Act in the case of unfiltered systems in Essex, Columbia, Greene, Dutchess, Rensselaer, Schoharie, Saratoga, Washington, and Warren Counties serving a population of less than 5000, which meet appropriate disinfection requirements and have adequate watershed protections, so long as the State determines that the public health will be protected during the duration of the additional compliance period and the system agrees to implement appropriate control measures as determined by the State.

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(2) The additional compliance period referred to in paragraph (1) shall expire on the earlier of the date 3 years after the date on which the Administrator identifies appropriate control technology for the Surface Water Treatment Rule for public water systems in the category that includes such system pursuant to Section 1412(b)(4)(E) of the Safe Drinking Water Act or 5 years after the date of enactment of the Safe Drinking Water Act Amendments of 1996. SECTION 133. SOURCE WATER PETITION PROGRAM (b) SENSE OF THE CONGRESS. It is the sense of the Congress that each State in establishing priorities under Section 606(c)(1) of the Federal Water Pollution Control Act should give special consideration to projects that are eligible for funding under that Act and have been recommended pursuant to a petition submitted under Section 1454 of the Safe Drinking Water Act. TITLE II—DRINKING WATER RESEARCH SECTION 201. DRINKING WATER RESEARCH AUTHORIZATION Other than amounts authorized to be appropriated to the Administrator of the Environmental Protection Agency under other titles of this Act, there are authorized to be appropriated such additional sums as may be necessary for drinking water research for fiscal years 1997 through 2003. The annual total of such additional sums authorized to be appropriated under this section shall not exceed $26,593,000. SECTION 202. SCIENTIFIC RESEARCH REVIEW (a) IN GENERAL. The Administrator shall (1) develop a strategic plan for drinking water research activities throughout the U.S. Environmental Protection Agency (in this section referred to as the ‘‘Agency’’); (2) integrate that strategic plan into ongoing Agency planning activities; and (3) review all Agency drinking water research to ensure the research (A) is of high quality; and (B) does not duplicate any other research being conducted by the Agency. (b) PLAN. The Administrator shall transmit the plan to the Committees on Commerce and Science of the House of Representatives and the Committee on Environment and Public Works of the Senate and the plan shall be made available to the public. SECTION 203. NATIONAL CENTER FOR GROUND WATER RESEARCH The Administrator of the Environmental Protection Agency, acting through the Robert S. Kerr Environmental Research Laboratory, is authorized to reestablish a partnership between the Laboratory and the National Center for Ground Water Research, a university consortium, to conduct research, training, and technology transfer for groundwater quality protection and restoration. No funds are authorized by this section. TITLE III—MISCELLANEOUS PROVISIONS SECTION 301. WATER RETURN FLOWS Section 3013 of Public Law 102-486 (42 USC 13551) is repealed.

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SECTION 302. TRANSFER OF FUNDS (a) IN GENERAL. Notwithstanding any other provision of law, at any time after the date 1 year after a State establishes a State loan fund pursuant to Section 1452 of the Safe Drinking Water Act but prior to fiscal year 2002, a Governor of the State may (1) reserve up to 33 percent of a capitalization grant made pursuant to such Section 1452 and add the funds reserved to any funds provided to the State pursuant to Section 601 of the Federal Water Pollution Control Act (33 USC 1381); and (2) reserve in any year a dollar amount up to the dollar amount that may be reserved under paragraph (1) for that year from capitalization grants made pursuant to Section 601 of such Act (33 USC 1381) and add the reserved funds to any funds provided to the State pursuant to Section 1452 of the Safe Drinking Water Act. (b) REPORT. Not later than 4 years after the date of enactment of this Act, the Administrator shall submit a report to the Congress regarding the implementation of this section, together with the Administrator’s recommendations, if any, for modifications or improvement. (c) STATE MATCH. Funds reserved pursuant to this section shall not be considered to be a State match of a capitalization grant required pursuant to Section 1452 of the Safe Drinking Water Act or the Federal Water Pollution Control Act (33 USC 1251 et seq.).

SECTION 303. GRANTS TO ALASKA TO IMPROVE SANITATION IN RURAL AND NATIVE VILLAGES (a) IN GENERAL. The Administrator of the U.S. Environmental Protection Agency may make grants to the State of Alaska for the benefit of rural and Native villages in Alaska to pay the Federal share of the cost of (1) the development and construction of public water systems and wastewater systems to improve the health and sanitation conditions in the villages; and (2) training, technical assistance, and educational programs relating to the operation and management of sanitation services in rural and Native villages. (b) FEDERAL SHARE. The Federal share of the cost of the activities described in subsection (a) shall be 50 percent. (c) ADMINISTRATIVE EXPENSES. The State of Alaska may use an amount not to exceed 4 percent of any grant made available under this subsection for administrative expenses necessary to carry out the activities described in subsection (a). (d) CONSULTATION WITH THE STATE OF ALASKA. The Administrator shall consult with the State of Alaska on a method of prioritizing the allocation of grants under subsection (a) according to the needs of, and relative health and sanitation conditions in, each eligible village. (e) AUTHORIZATION OF APPROPRIATIONS. There are authorized to be appropriated $15,000,000 for each of the fiscal years 1997 through 2000 to carry out this section.

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SECTION 304. SENSE OF THE CONGRESS It is the sense of the Congress that appropriations for grants under Section 128 (relating to New York City watershed), Section 135 (relating to colonias), and Section 307 (relating to Alaska Native villages) should not be provided if such appropriations would prevent the adequate capitalization of State revolving loan funds.

SECTION 305. BOTTLED DRINKING WATER STANDARDS Section 410 of the Federal Food, Drug, and Cosmetic Act (21 USC 349) is amended as follows: (1) By striking ‘‘Whenever’’ and inserting ‘‘(a) Except as provided in subsection (b), whenever.’’ (2) By adding at the end the following new subsection: ‘‘(b)(1) Not later than 180 days before the effective date of a national primary drinking water regulation promulgated by the Administrator of the U.S. Environmental Protection Agency for a contaminant under Section 1412 of the Safe Drinking Water Act (42 USC 300-1), the Secretary shall promulgate a standard of quality regulation under this subsection for that contaminant in bottled water or make a finding that such a regulation is not necessary to protect the public health because the contaminant is contained in water in public water systems {as defined under Section 1401(4) of such Act [42 USC 300f(4)]} but not in water used for bottled drinking water. The effective date for any such standard of quality regulation shall be the same as the effective date for such national primary drinking water regulation, except for any standard of quality of regulation promulgated by the Secretary before the date of enactment of the Safe Drinking Water Act Amendments of 1996 for which (as of such date of enactment) an effective date had not been established. In the case of a standard of quality regulation to which such exception applies, the Secretary shall promulgate monitoring requirements for the contaminants covered by the regulation not later than 2 years after such date of enactment. ‘‘(2) A regulation issued by the Secretary as provided in this subsection shall include any monitoring requirements that the Secretary determines appropriate for bottled water. ‘‘(3) A regulation issued by the Secretary as provided in this subsection shall require the following: ‘‘(A) In the case of contaminants for which a maximum contaminant level is established in a national primary drinking water regulation under Section 1412 of the Safe Drinking Water Act (42 USC 300g-1), the regulation under this subsection shall establish a maximum contaminant level for the contaminant in bottled water which is no less stringent than the maximum contaminant level provided in the national primary drinking water regulation. ‘‘(B) In the case of contaminants for which a treatment technique is established in a national primary drinking water regulation under Section 1412 of the Safe Drinking Water Act (42 USC 300g-1), the regulation under this subsection shall require that bottled water be subject to requirements no less protective of the public health

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than those applicable to water provided by public water systems using the treatment technique required by the national primary drinking water regulation. ‘‘(4)(A) If the Secretary does not promulgate a regulation under this subsection within the period described in paragraph (1), the national primary drinking water regulation referred to in paragraph (1) shall be considered, as of the date on which the Secretary is required to establish a regulation under paragraph (1), as the regulation applicable under this subsection to bottled water. ‘‘(B) In the case of a national primary drinking water regulation that pursuant to subparagraph (A) is considered to be a standard of quality regulation, the Secretary shall, not later than the applicable date referred to in such subparagraph, publish in the Federal Register a notice ‘‘(i) specifying the contents of such regulation, including monitoring requirements; and ‘‘(ii) providing that for purposes of this paragraph the effective date for such regulation is the same as the effective date for the regulation for purposes of the Safe Drinking Water Act [or, if the exception under paragraph (1) applies to the regulation, that the effective date for the regulation is not later than 2 years and 180 days after the date of enactment of the Safe Drinking Water Act Amendments of 1996].’’

SECTION 306. WASHINGTON AQUEDUCT (a) DEFINITIONS. In this section (1) NONFEDERAL PUBLIC WATER SUPPLY CUSTOMER. The terms ‘‘nonFederal public water supply customer’’ and ‘‘customer’’ mean (A) the District of Columbia; (B) Arlington County, Virginia; and (C) the city of Falls Church, Virginia. (2) SECRETARY. The term ‘‘Secretary’’ means the Secretary of the Army, acting through the Chief of Engineers. (3) VALUE TO THE GOVERNMENT. The term ‘‘value to the government’’ means the net present value of a contract entered into under subsection (e)(2), calculated in accordance with subparagraphs (A) and (B) of Section 502(5) of the Congressional Budget Act of 1974 [2 USC 66la(5)], other than Section 502(5)(B)(I) of the Act, as though the contract provided for repayment of a direct loan to a customer. (4) WASHINGTON AQUEDUCT. The term ‘‘Washington Aqueduct’’ means the Washington Aqueduct facilities and related facilities owned by the Federal Government as of the date of enactment of this Act, including (A) the dams, intake works, conduits, and pump stations that capture and transport raw water from the Potomac River to the Dalecarlia Reservoir; (B) the infrastructure and appurtenances used to treat water taken from the Potomac River to potable standards; and (C) related water distribution facilities. (b) REGIONAL ENTITY

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(1) IN GENERAL. The Congress encourages and grants consent to the customers to establish a non-Federal public or private entity, or to enter into an agreement with an existing non-Federal public or private entity, to (A) receive title to the Washington Aqueduct; and (B) operate, maintain, and manage the Washington Aqueduct in a manner that adequately represents all interests of its customers. (2) CONSIDERATION. If an entity receiving title to the Washington Aqueduct is not composed entirely of non-Federal public water supply customers, the entity shall consider the customers’ historical provision of equity for the Aqueduct. (3) PRIORITY ACCESS. The customers shall have priority access to any water produced by the Washington Aqueduct. (4) CONSENT OF THE CONGRESS. The Congress grants consent to the customers to enter into any interstate agreement or compact required to carry out this section. (5) STATUTORY CONSTRUCTION. This section shall not preclude the customers from pursuing any option regarding ownership, operation, maintenance, and management of the Washington Aqueduct. (c) PROGRESS REPORT AND PLAN. Not later than 1 year after the date of enactment of this Act, the Secretary shall report to the Committee on Environment and Public Works of the Senate and the Committee on Transportation and Infrastructure of the House of Representatives on any progress in achieving the objectives of subsection (b)(1) and shall submit a plan for the transfer of ownership, operation, maintenance, and management of the Washington Aqueduct to a non-Federal public or private entity. Such plan shall include a detailed consideration of any proposal to transfer such ownership, maintenance, or management to a private entity. (d) TRANSFER (1) IN GENERAL. Subject to subsection (b)(2), the other provisions of this subsection, and any other terms and conditions the Secretary considers appropriate to protect the interests of the United States, the Secretary shall, not later than 3 years after the date of enactment of this Act and with the consent of a majority of the customers and without consideration to the Federal Government, transfer all rights, titles, and interests of the United States in the Washington Aqueduct, and its real property, facilities, and personalty, to a non-Federal, public or private entity. Approval of such transfer shall not be unreasonably withheld by the Secretary. (2) ADEQUATE CAPABILITIES. The Secretary shall transfer ownership of the Washington Aqueduct under paragraph (1) only if the Secretary determines, after opportunity for public input, that the entity to receive ownership of the Aqueduct has the technical, managerial, and financial capability to operate, maintain, and manage the Aqueduct. (3) RESPONSIBILITIES. The Secretary shall not transfer title under this subsection unless the entity to receive title assumes full responsibility for performing and financing the operation, maintenance, repair, replacement, rehabilitation, and necessary capital improvements of the Washington Aqueduct so as to ensure the continued operation of the Washington Aqueduct consistent with the Aqueduct’s intended

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purpose of providing an uninterrupted supply of potable water sufficient to meet the current and future needs of the Aqueduct’s service area. (e) BORROWING AUTHORITY (1) BORROWING (A) IN GENERAL. Subject to the other provisions of this paragraph and paragraph (2), the Secretary is authorized to borrow from the Treasury of the United States such amounts for fiscal years 1997, 1998, and 1999 as are sufficient to cover any obligations that the Army Corps of Engineers is required to incur in carrying out capital improvements during fiscal years 1997, 1998, and 1999 for the Washington Aqueduct to ensure continued operation of the Aqueduct until such time as a transfer of title to the Aqueduct has taken place. (B) LIMITATION. The amount borrowed by the Secretary under subparagraph (A) may not exceed $29,000,000 for fiscal year 1997, $24,000,000 for fiscal year 1998, and $22,000,000 for fiscal year 1999. (C) AGREEMENT. Amounts borrowed under subparagraph (A) may only be used for capital improvements agreed to by the Army Corps of Engineers and the customers. (D) TERMS OF BORROWING (i) IN GENERAL. The Secretary of the Treasury shall provide the funds borrowed under subparagraph (A) under such terms and conditions as the Secretary of Treasury determines to be necessary and in the public interest and subject to the contracts required under paragraph (2). (ii) TERM. The term of any loan made under subparagraph (A) shall be for a period of not less than 20 years. (iii) PREPAYMENT. There shall be no penalty for the prepayment of any amounts borrowed under subparagraph (A). (2) CONTRACTS WITH CUSTOMERS (A) IN GENERAL. The borrowing authority under paragraph (1)(A) shall be effective only after the Chief of Engineers has entered into contracts with each customer under which the customer commits to repay a pro rata share (based on water purchase) of the principal and interest owed by the Secretary to the Secretary of the Treasury under paragraph (1). (B) PREPAYMENT. Any customer may repay, at any time, the pro rata share of the principal and interest then owed by the customer and outstanding, or any portion thereof, without penalty. (C) RISK OF DEFAULT. Under each of the contracts, the customer that enters into the contract shall commit to pay any additional amount necessary to fully offset the risk of default on the contract. (D) OBLIGATIONS. Each contract under subparagraph (A) shall include such terms and conditions as the Secretary of the Treasury may require so that the value to the Government of the contracts entered into under subparagraph (A) is estimated to be equal to the obligations of the Army Corps of Engineers for carrying out capital improvements at the Washington Aqueduct at the time that each series of contracts is entered into.

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(E) OTHER CONDITIONS. Each contract entered into under subparagraph (A) shall (i) provide that the customer pledges future income only from fees assessed for principal and interest payments required by such contracts and costs to operate and maintain the Washington Aqueduct; (ii) provide the United States priority in regard to income from fees assessed to operate and maintain the Washington Aqueduct; and (iii) include other conditions consistent with this section that the Secretary of the Treasury determines to be appropriate. (3) LIMITATIONS (A) BORROWING AUTHORITY. The Secretary’s borrowing authority for making capital improvements at the Washington Aqueduct under paragraph (1) shall not extend beyond fiscal year 1999. (B) OBLIGATION AUTHORITY. Upon expiration of the borrowing authority exercised under paragraph (1), the Secretary shall not obligate funds for making capital improvements at the Washington Aqueduct except funds which are provided in advance by the customers. This limitation does not affect the Secretary’s authority to conduct normal operation and maintenance activities, including minor repair and replacement work. (4) IMPACT ON IMPROVEMENT PROGRAM. Not later than 180 days after the date of enactment of this Act, the Secretary, in consultation with other Federal agencies, shall transmit to the Committee on Environment and Public Works of the Senate and the Committee on Transportation and Infrastructure of the House of Representatives a report that assesses the impact of the borrowing authority provided under this subsection on the near-term improvement projects in the Washington Aqueduct Improvement Program, work scheduled, and the financial liability to be incurred. (f) REISSUANCE OF NPDES PERMIT. Prior to reissuing a National Pollutant Discharge Elimination System (NPDES) permit for the Washington Aqueduct, the Administrator of the U.S. Environmental Protection Agency shall consult with the customers and the Secretary regarding opportunities for more efficient water facility configurations that might be achieved through various possible transfers of the Washington Aqueduct. Such consultation shall include specific consideration of concerns regarding a proposed solids recovery facility, and may include a public hearing.

SECTION 307. WASTEWATER ASSISTANCE TO COLONIAS (a) DEFINITIONS. As used in this section (1) BORDER STATE. The term ‘‘border State’’ means Arizona, California, New Mexico, and Texas. (2) ELIGIBLE COMMUNITY. The term ‘‘eligible community’’ means a low-income community with economic hardship that (A) is commonly referred to as a colonia;

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(B) is located along the United States–Mexico border (generally in an unincorporated area); and (C) lacks basic sanitation facilities such as household plumbing or a proper sewage disposal system. (3) TREATMENT WORKS. The term ‘‘treatment works’’ has the meaning provided in Section 212(2) of the Federal Water Pollution Control Act (33 USC 1292(2)]. (b) GRANTS FOR WASTEWATER ASSISTANCE. The Administrator of the U.S. Environmental Protection Agency and the heads of other appropriate Federal agencies are authorized to award grants to a border State to provide assistance to eligible communities for the planning, design, and construction or improvement of sewers, treatment works, and appropriate connections for wastewater treatment. (c) USE OF FUNDS. Each grant awarded pursuant to subsection (b) shall be used to provide assistance to one or more eligible communities with respect to which the residents are subject to a significant health risk (as determined by the Administrator or the head of the Federal agency making the grant) attributable to the lack of access to an adequate and affordable treatment works for wastewater. (d) COST SHARING. The amount of a grant awarded pursuant to this section shall not exceed 50 percent of the costs of carrying out the project that is the subject of the grant. (e) AUTHORIZATION OF APPROPRIATIONS. There are authorized to be appropriated to carry out this section $25,000,000 for each of the fiscal years 1997 through 1999. SECTION 308. PREVENTION AND CONTROL OF ZEBRA MUSSEL INFESTATION OF LAKE CHAMPLAIN (a) FINDINGS. Section 1002(a) of the Nonindigenous Aquatic Nuisance Prevention and Control Act of 1990 [16 USC 4701(a)] is amended as follows: (1) By striking ‘‘and’’ at the end of paragraph (3). (2) By striking the period at the end of paragraph (4) and inserting ‘‘; and’’. (3) By adding at the end the following new paragraph: ‘‘(5) the zebra mussel was discovered on Lake Champlain during 1993 and the opportunity exists to act quickly to establish zebra mussel controls before Lake Champlain is further infested and management costs escalate.’’ (b) EX OFFICIO MEMBERS OF AQUATIC NUISANCE SPECIES TASK FORCE. Section 1201(c) of such Act [16 USC 4721(c)] is amended by inserting ‘‘the Lake Champlain Basin Program’’ after ‘‘Great Lakes Commission.’’ TITLE IV—ADDITIONAL ASSISTANCE FOR WATER INFRASTRUCTURE AND WATERSHEDS SECTION 401. NATIONAL PROGRAM (a) TECHNICAL AND FINANCIAL ASSISTANCE. The Administrator of the Environmental Protection Agency may provide technical and financial assistance in the form of grants to States (1) for the construction, rehabilitation, and improvement of water supply systems, and (2) consistent with nonpoint source management programs established under Section 319 of the Federal Water Pollution Control

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Act, for source water quality protection programs to address pollutants in navigable waters for the purpose of making such waters usable by water supply systems. (b) LIMITATION. Not more than 30 percent of the amounts appropriated to carry out this section in a fiscal year may be used for source water quality protection programs described in subsection (a)(2). (c) CONDITION. As a condition to receiving assistance under this section, a State shall ensure that such assistance is carried out in the most cost-effective manner, as determined by the State. (d) AUTHORIZATION OF APPROPRIATIONS (1) UNCONDITIONAL AUTHORIZATION. There are authorized to be appropriated to carry out this section $25,000,000 for each of fiscal years 1997 through 2003. Such sums shall remain available until expended. (2) CONDITIONAL AUTHORIZATION. In addition to amounts authorized under paragraph (1), there are authorized to be appropriated to carry out this title $25,000,000 for each of fiscal years 1997 through 2003, provided that such authorization shall be in effect for a fiscal year only if at least 75 percent of the total amount of funds authorized to be appropriated for such fiscal year by Section 1452(m) of the Safe Drinking Water Act are appropriated. (e) ACQUISITION OF LANDS. Assistance provided with funds made available under this title may be used for the acquisition of lands and other interests in lands; however, nothing in this title authorizes the acquisition of lands or other interests in lands from other than willing sellers. (f) FEDERAL SHARE. The Federal share of the cost of activities for which grants are made under this title shall be 50 percent. (g) DEFINITIONS. In this section, the following definitions apply: (1) STATE. The term ‘‘State’’ means a State, the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, Guam, American Samoa, and the Commonwealth of the Northern Mariana Islands. (2) WATER SUPPLY SYSTEM. The term ‘‘water supply system’’ means a system for the provision to the public of piped water for human consumption if such system has at least 15 service connections or regularly serves at least 25 individuals and a draw-and-fill system for the provision to the public of water for human consumption. Such term does not include a system owned by a Federal agency. Such term includes (A) any collection, treatment, storage, and distribution facilities under control of the operator of such system and used primarily in connection with such system, and (B) any collection or pretreatment facilities not under such control that are used primarily in connection with such system.

From Public Law 104-208, Sept. 30, 1996 SCIENCE AND TECHNOLOGY For an additional amount for ‘‘Science and Technology,’’ $10,000,000, to remain available until September 30, 1998, to conduct health effects research to carry out

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the purposes of the Safe Drinking Water Act Amendments of 1996, Public Law 104182.

ENVIRONMENTAL PROGRAMS AND MANAGEMENT For an additional amount for ‘‘Environmental Programs and Management,’’ $42,221,000, to remain available until September 30, 1998, of which $30,000,000 is to carry out the purposes of the Safe Drinking Water Act Amendments of 1996, Public Law 104-182, and the purposes of the food Quality Protection Act of 1996, Public Law 104-170, and of which $10,221,000 is for pesticide residue data collection for use in risk assessment activities.

PROVISIONS FROM LAWS RELATED TO THE SDWA

From Public Law 104-170, Aug. 3, 1996 ESTROGENIC SUBSTANCES SCREENING PROGRAM (p) ESTROGENIC SUBSTANCES SCREENING PROGRAM (1) DEVELOPMENT. Not later than 2 years after the date of enactment of this section, the Administrator shall in consultation with the Secretary of Health and Human Services develop a screening program, using appropriate validated test systems and other scientifically relevant information, to determine whether certain substances may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen, or such other endocrine effect as the Administrator may designate. (2) IMPLEMENTATION. Not later than 3 years after the date of enactment of this section, after obtaining public comment and review of the screening program described in paragraph (1) by the scientific advisory panel established under Section 25(d) of the Federal Insecticide, Fungicide, and Rodenticide Act or the science advisory board established by Section 8 of the Environmental Research, Development, and Demonstration Act of 1978 (42 USC 4365), the Administrator shall implement the program. (3) SUBSTANCES. In carrying out the screening program described in paragraph (1), the Administrator (A) shall provide for the testing of all pesticide chemicals; and (B) may provide for the testing of any other substance that may have an effect that is cumulative to an effect of a pesticide chemical if the Administrator determines that a substantial population may be exposed to such substance. (4) EXEMPTION. Notwithstanding paragraph (3), the Administrator may, by order, exempt from the requirements of this section a biologic substance or other substance if the Administrator determines that the substance is anticipated not to

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produce any effect in humans similar to an effect produced by a naturally occurring estrogen. (5) COLLECTION OF INFORMATION (A) IN GENERAL. The Administrator shall issue an order to a registrant of a substance for which testing is required under this subsection, or to a person who manufactures or imports a substance for which testing is required under this subsection, to conduct testing in accordance with the screening program described in paragraph (1), and submit information obtained from the testing to the Administrator, within a reasonable time period that the Administrator determines is sufficient for the generation of the information. (B) PROCEDURES. To the extent practicable the Administrator shall minimize duplicative testing of the same substance for the same endocrine effect, develop, as appropriate, procedures for fair and equitable sharing of test costs, and develop, as necessary, procedures for handling of confidential business information. (C) FAILURE OF REGISTRANTS TO SUBMIT INFORMATION (i) SUSPENSION. If a registrant of a substance referred to in paragraph (3)(A) fails to comply with an order under subparagraph (A) of this paragraph, the Administrator shall issue a notice of intent to suspend the sale or distribution of the substance by the registrant. Any suspension proposed under this paragraph shall become final at the end of the 30-day period beginning on the date that the registrant receives the notice of intent to suspend, unless during that period a person adversely affected by the notice requests a hearing or the Administrator determines that the registrant has complied fully with this paragraph. (ii) HEARING. If a person requests a hearing under clause (i), the hearing shall be conducted in accordance with Section 554 of Title 5, United States Code. The only matter for resolution at the hearing shall be whether the registrant has failed to comply with an order under subparagraph (A) of this paragraph. A decision by the Administrator after completion of a hearing shall be considered to be a final agency action. (iii) TERMINATION OF SUSPENSIONS. The Administrator shall terminate a suspension under this subparagraph issued with respect to a registrant if the Administrator determines that the registrant has complied fully with this paragraph. (D) NONCOMPLIANCE BY OTHER PERSONS. Any person (other than a registrant) who fails to comply with an order under subparagraph (A) shall be liable for the same penalties and sanctions as are provided under Section 16 of the Toxic Substances Control Act (15 USC 2601 et seq.) in the case of a violation referred to in that section. Such penalties and sanctions shall be assessed and imposed in the same manner as provided in such Section 16. (6) AGENCY ACTION. In the case of any substance that is found, as a result of testing and evaluation under this section, to have an endocrine effect on humans, the Administrator shall, as appropriate, take action under such statutory authority as is available to the Administrator, including consideration under other sections of this Act, as is necessary to ensure the protection of public health. (7) REPORT TO CONGRESS. Not later than 4 years after the date of enactment of this section, the Administrator shall prepare and submit to Congress a report containing

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(A) the findings of the Administrator resulting from the screening program described in paragraph (1); (B) recommendations for further testing needed to evaluate the impact on human health of the substances tested under the screening program; and (C) recommendations for any further actions [including any action described in paragraph (6)] that the Administrator determines are appropriate based on the findings. From H.R. 2620 Conference Committee report, 107th Congress. 107th Congress Report HOUSE OF REPRESENTATIVES 1st Session (107-272) MAKING APPROPRIATIONS FOR THE DEPARTMENTS OF VETERANS AFFAIRS AND HOUSING AND URBAN DEVELOPMENT, AND FOR SUNDRY INDEPENDENT AGENCIES, BOARDS, COMMISSIONS, CORPORATIONS, AND OFFICES FOR THE FISCAL YEAR ENDING SEPTEMBER 30, 2002, AND FOR OTHER PURPOSES November 6, 2001. Ordered to be printed Mr. Walsh, from the committee of conference, submitted the following CONFERENCE REPORT [To accompany H.R. 2620] The conferees have included modified language related to a national primary drinking water standard for arsenic as published in the Federal Register on January 22, 2001, instead of language proposed by the House and the Senate. The language adopted by the conferees prohibits a delay in setting a new regulation other than that prescribed in the final rule of January 22, 2001, which includes an arsenic standard of 10 parts per billion (ppb). In adopting this legislative provision, the conferees acknowledge that an arsenic standard of 10 ppb will likely pose significant financial costs on many small communities, and many of these communities may find it impossible, because of the financial burden, to be in compliance by 2006 as the rule requires. The conferees are concerned that, because of their complexity, the current waiver and exemption provisions found in Sections 1415 and 1416 of the Safe Drinking Water Act, as amended, may not provide sufficient flexibility for the small communities to receive additional time to reach compliance. As a result, the conferees are very concerned that numerous small community water systems may not be in compliance by 2006, and that some very small communities may abandon their municipal systems in favor of untreated and unregulated private wells that could create significant other health risks for these communities. The conferees agree that Congress and the Administration must act swiftly to provide both the time and the means for many small communities to meet the new 10-ppb standard. To this end,

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the conferees direct the Administrator of U.S. EPA to begin immediately to review the Agency’s affordability criteria and how small system variance and exemption programs should be implemented for arsenic. In addition, the Administrator should recommend procedures to grant an extension of time in meeting the compliance requirement for small communities when a community can show to the satisfaction of the Administrator that being in compliance by 2006 poses an undue economic hardship on that community. In developing these procedures, the Administrator should consider those actions that can be taken administratively by the Agency and those that will require the enactment of legislation. The conferees do not intend to create loopholes in the Safe Drinking Water Act for compliance to a national arsenic standard. Rather, the conferees wish to emphasize that they expect the Agency to adopt without delay all appropriate available administrative actions permitted under existing law to facilitate reasonable extensions of time for compliance of these communities. The Agency is directed to report to Congress by March 1, 2002 on its review of the affordability criteria and the administrative actions undertaken or planned to be undertaken by the Agency, as well as potential funding mechanisms for small community compliance and other legislative actions, which, if taken by Congress, would best achieve appropriate extensions of time for small communities while also guaranteeing maximum compliance.

Appendix E HOW OUR LAWS ARE MADE CHARLES W. JOHNSON Parliamentarian, U.S. House of Representatives

FOREWORD First published in 1953 by the Committee on the Judiciary of the House of Representatives, this 22nd edition of How Our Laws Are Made reflects changes in congressional procedures since the 21st edition, which was revised and updated in 1997. This edition was prepared by the Office of the Parliamentarian of the U.S. House of Representatives in consultation with the Office of the Parliamentarian of the U.S. Senate. The framers of our Constitution created a strong federal government resting on the concept of ‘‘separation of powers.’’ In Article I, Section 1, of the Constitution, the Legislative Branch is created by the following language: ‘‘All legislative Powers herein granted shall be vested in a Congress of the United States, which shall consist of a Senate and House of Representatives.’’ On this elegant, yet simple, grant of legislative powers has grown an exceedingly complex and evolving legislative process. To aid the public’s understanding of the legislative process, we have revised this popular brochure. For more detailed information on how our laws are made and for the text of the laws themselves, the reader should refer to government Internet sites or pertinent House and Senate publications available from the Superintendent of Documents, U.S. Government Printing Office, Washington, DC 20402. CHARLES W. JOHNSON Drinking Water Regulation and Health, Edited by Frederick W. Pontius. ISBN 0-471-41554-5 # 2003 John Wiley & Sons, Inc.

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Introduction Congress Sources of Legislation Forms of Congressional Action Bills Joint Resolutions Concurrent Resolutions Simple Resolutions Introduction and Referral to Committee Consideration by Committee Committee Meetings Public Hearings Markup Final Committee Action Points of Order with Respect to Committee Hearing Procedure Reported Bills Contents of Reports Filing of Reports Availability of Reports and Hearings Legislative Oversight by Standing Committees Calendars Union Calendar House Calendar Private Calendar Corrections Calendar Calendar of Motions to Discharge Committees Obtaining Consideration of Measures Unanimous Consent Special Resolution or ‘‘Rule’’ Consideration of Measures Made in Order by Rule Reported from the Committee on Rules Motion to Discharge Committee Motion to Suspend the Rules Calendar Wednesday District of Columbia Business Questions of Privilege Privileged Matters Consideration and Debate Committee of the Whole House Second Reading Amendments and the Germaneness Rule The Committee ‘‘Rises’’ House Action Motion to Recommit Quorum Calls and Roll Calls Nonelectronic Voting Electronic Voting Pairing of Members System of Lights and Bells Recess Authority

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Live Coverage of Floor Proceedings Congressional Budget Process Engrossment and Message to Senate Senate Action Committee Consideration Chamber Procedure Final Action on Amended Bill Request for a Conference Authority of Conferees Meetings and Action of Conferees Conference Reports Custody of Papers Bill Originating in Senate Enrollment Presidential Action Veto Message Line Item Veto Publication Slip Laws Statutes at Large United States Code Appendix: Select List of Government Publications

INTRODUCTION This brochure is intended to provide a basic outline of the numerous steps of our federal lawmaking process from the source of an idea for a legislative proposal through its publication as a statute. The legislative process is a matter about which every citizen should be well informed in order to understand and appreciate the work of Congress. It is hoped that this guide will enable every citizen to gain a greater understanding of the federal legislative process and its role as one of the foundations of our representative system. One of the most practical safeguards of the American democratic way of life is this legislative process with its emphasis on the protection of the minority, allowing ample opportunity to all sides to be heard and make their views known. The fact that a proposal cannot become a law without consideration and approval by both Houses of Congress is an outstanding virtue of our bicameral legislative system. The open and full discussion provided under the Constitution often results in the notable improvement of a bill by amendment before it becomes law or in the eventual defeat of an inadvisable proposal. As the majority of laws originate in the House of Representatives, this discussion focuses principally on the procedure in that body.

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CONGRESS Article I, Section 1, of the United States Constitution, provides that ‘‘All legislative Powers herein granted shall be vested in a Congress of the United States, which shall consist of a Senate and House of Representatives.’’ The U.S. Senate is composed of 100 Members—two from each state, regardless of population or area—elected by the people in accordance with the 17th Amendment to the Constitution. The 17th Amendment changed the former constitutional method under which Senators were chosen by the respective state legislatures. A Senator must be at least 30 years of age, have been a citizen of the United States for 9 years, and, when elected, be a resident of the state where elected. The term of office is 6 years, and one-third of the total membership of the Senate is elected every second year. The terms of both Senators from a particular state are arranged so that they do not terminate at the same time. Of the two Senators from a state serving at the same time, the one who was elected first—or if both were elected at the same time, the one elected for a full term—is referred to as the ‘‘senior’’ Senator from that state. The other is referred to as the ‘‘junior’’ Senator. If a Senator dies or resigns during the term, the governor of the state must call a special election unless the state legislature has authorized the governor to appoint a successor until the next election, at which time a successor is elected for the balance of the term. Most of the state legislatures have granted their governors the power of appointment. Each senator has one vote. As constituted in the 105th Congress, the House of Representatives is composed of 435 Members elected every 2 years from among the 50 states, apportioned to their total populations. The permanent number of 435 was established by federal law following the Thirteenth Decennial Census in 1910, in accordance with Article I, Section 2, of the U.S. Constitution. This number was increased temporarily to 437 for the 87th Congress to provide for one Representative each for Alaska and Hawaii. The U.S. Constitution limits the number of Representatives to not more than one for every 30,000 of population. Under a former apportionment in one state, a particular Representative represented more than 900,000 constituents, while another in the same state was elected from a district having a population of only 175,000. The U.S. Supreme Court has since held unconstitutional a Missouri statute permitting a maximum population variance of 3.1% from mathematical equality. The Court ruled in Kirkpatrick v. Preisler, 394 U.S. 526 (1969), that the variances among the districts were not unavoidable and, therefore, were invalid. That decision was an interpretation of the Court’s earlier ruling in Wesberry v. Sanders, 376 U.S. 1 (1964), that the Constitution requires that ‘‘as nearly as is practicable one man’s vote in a congressional election is to be worth as much as another’s.’’ A law enacted in 1967 abolished all ‘‘at-large’’ elections except in those less populous states entitled to only one Representative. An ‘‘at-large’’ election is one in which a Representative is elected by the voters of the entire state rather than by the voters in a congressional district within the state.

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A Representative must be at least 25 years of age, have been a citizen of the United States for 7 years, and, when elected, be a resident of the state in which the election was held. If a Representative dies or resigns during the term, the governor of the state must call a special election pursuant to state law for the choosing of a successor to serve for the unexpired portion of the term. Each Representative has one vote. In addition to the Representatives from each of the states, a resident Commissioner from the Commonwealth of Puerto Rico and Delegates from the District of Columbia, American Samoa, Guam, and the Virgin Islands are elected pursuant to federal law. The Resident Commissioner and the Delegates have most of the prerogatives of Representatives, including the right to vote in committees to which they are elected. However, the Resident Commissioner and the Delegates do not have the right to vote on matters before the House. Under the provisions of Section 2 of the 20th Amendment to the Constitution, Congress must assemble at least once every year, at noon on the third day of January, unless by law they select a different day. A Congress lasts for 2 years, commencing in January of the year following the biennial election of Members. A Congress is divided into two sessions. The Constitution authorizes each House to determine the rules of its proceedings. Pursuant to that authority, the House of Representatives adopts its rules on the opening day of each Congress. The Senate considers itself a continuing body and operates under continuous standing rules that it amends from time to time. Unlike some other parliamentary bodies, both the Senate and the House of Representatives have equal legislative functions and powers with certain exceptions. For example, the Constitution provides that only the House of Representatives originate revenue bills. By tradition, the House also originates appropriation bills. As both bodies have equal legislative powers, the designation of one as the ‘‘upper’’ House and the other as the ‘‘lower’’ House is not appropriate. The chief function of Congress is to make laws. In addition, the Senate has the function of advising and consenting to treaties and to certain nominations by the President. However, under the 25th Amendment to the Constitution, both Houses confirm the President’s nomination for Vice President when there is a vacancy in that office. In the matter of impeachments, the House of Representatives presents the charges—a function similar to that of a grand jury—and the Senate sits as a court to try the impeachment. No impeached person may be removed without a two-thirds vote of the Senate. Congress also plays a role in presidential elections. Both Houses meet in joint session on the sixth day of January, following a presidential election, unless by law they appoint a different day, to count the electoral votes. If no candidate receives a majority of the total electoral votes, the House of Representatives, each state delegation having one vote, chooses the President from among the three candidates having the largest number of electoral votes. The Senate, where each senator has one vote, chooses the Vice President from the two candidates having the largest number of votes for that office.

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SOURCES OF LEGISLATION Sources of ideas for legislation are unlimited and proposed drafts of bills originate in many diverse quarters. Primary among these is the idea and draft conceived by a Member or Delegate. This may emanate from the election campaign during which the Member had promised, if elected, to introduce legislation on a particular subject. The Member may have also become aware after taking office of the need for amendment to or repeal of an existing law or the enactment of a statute in an entirely new field. In addition, the Member’s constituents, either as individuals or through citizen groups may avail themselves of the right to petition and transmit their proposals to the Member. The right to petition is guaranteed by the First Amendment to the Constitution. Many excellent laws have originated in this way, as some organizations, because of their vital concern with various areas of legislation, have considerable knowledge regarding the laws affecting their interests and have the services of legislative draftspersons for this purpose. Similarly, state legislatures may ‘‘memorialize’’ Congress to enact specified federal laws by passing resolutions to be transmitted to the House and Senate as memorials. If favorably impressed by the idea, the Member may introduce the proposal in the form in which it has been submitted or may redraft it. In any event, the Member may consult with the Legislative Counsel of the House or the Senate to frame the ideas in suitable legislative language and form. In modern times, the ‘‘executive communication’’ has become a prolific source of legislative proposals. The communication is usually in the form of a message or letter from a member of the President’s Cabinet, the head of an independent agency, or the President transmitting a draft of a proposed bill to the Speaker of the House of Representatives and the President of the Senate. Despite the structure of separation of powers, Article II, Section 3, of the Constitution imposes an obligation on the President to report to Congress from time to time on the ‘‘State of the Union’’ and to recommend for consideration such measures as the President considers necessary and expedient. Many of these executive communications follow on the President’s message to Congress on the state of the Union. The communication is then referred to the standing committee or committees having jurisdiction of the subject matter of the proposal. The chairman or the ranking minority member of the relevant committee usually introduces the bill promptly either in the form in which it was received or with desired changes. This practice is usually followed even when the majority of the House and the President are not of the same political party, although there is no constitutional or statutory requirement that a bill be introduced to effectuate the recommendations. The committee or one of its subcommittees may also decide to examine the communication to determine whether a bill should be introduced. The most important of the regular executive communications is the annual message from the President transmitting the proposed budget to Congress. The President’s budget proposal, together with testimony by officials of the various branches of the government before the Appropriations Committees of the House and Senate, is the basis of the several appropriation bills that are drafted by the Committee on Appropriations of the House.

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Many of the executive departments and independent agencies employ legislative counsels who are charged with the drafting of bills. These legislative proposals are forwarded to Congress with a request for their enactment. The drafting of statutes is an art that requires great skill, knowledge, and experience. In some instances, a draft is the result of a study covering a period of a year or more by a commission or committee designated by the President or a member of the cabinet. The Administrative Procedure Act and the Uniform Code of Military Justice are two examples of enactments resulting from such studies. In addition, congressional committees sometimes draft bills after studies and hearings covering periods of a year or more.

FORMS OF CONGRESSIONAL ACTION The work of Congress is initiated by the introduction of a proposal in one of four forms: the bill, the joint resolution, the concurrent resolution, and the simple resolution. The most customary form used in both Houses is the bill. During the 105th Congress (1997=8), 7529 bills and 200 joint resolutions were introduced in both Houses. Of the total number introduced, 4874 bills and 140 joint resolutions originated in the House of Representatives. For the purpose of simplicity, this discussion will be confined generally to the procedure on a House of Representatives bill, with brief comment on each of the forms. Bills A bill is the form used for most legislation, whether permanent or temporary, general or special, public or private. The form of a House bill is as follows: A BILL For the establishment, etc. [as the title may be]. Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, That, etc.

The enacting clause was prescribed by law in 1871 and is identical in all bills, whether they originate in the House of Representatives or in the Senate. Bills may originate in either the House of Representatives or the Senate with one notable exception provided in the Constitution. Article I, Section 7, of the Constitution provides that all bills for raising revenue shall originate in the House of Representatives but that the Senate may propose or concur with amendments. By tradition, general appropriation bills also originate in the House of Representatives. There are two types of bills: public and private. A public bill is one that affects the public generally. A bill that affects a specified individual or a private entity rather than the population at large is called a private bill. A typical private bill is used for

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relief in matters such as immigration and naturalization and claims against the United States. A bill originating in the House of Representatives is designated by the letters ‘‘H.R.’’ followed by a number that it retains throughout all its parliamentary stages. The letters signify ‘‘House of Representatives’’ and not, as is sometimes incorrectly assumed, ‘‘House resolution.’’ A Senate bill is designated by the letter ‘‘S.’’ followed by its number. The term ‘‘companion bill’’ is used to describe a bill introduced in one House of Congress that is similar or identical to a bill introduced in the other House of Congress. A bill that has been agreed to in identical form by both bodies becomes the law of the land only after (1) Presidential approval, (2) failure by the President to return it with objections to the House in which it originated within 10 days while Congress is in session, or (3) the overriding of a presidential veto by a two-thirds vote in each House. The bill does not become law without the President’s signature if Congress by their final adjournment prevent its return with objections. This is known as a ‘‘pocket veto.’’

Joint Resolutions Joint resolutions may originate either in the House of Representatives or in the Senate—not, as is sometimes incorrectly assumed, jointly in both Houses. There is little practical difference between a bill and a joint resolution, and the two forms are often used interchangeably. One difference in form is that a joint resolution may include a preamble preceding the resolving clause. Statutes that have been initiated as bills have later been amended by a joint resolution and vice versa. Both are subject to the same procedure except for a joint resolution proposing an amendment to the Constitution. When a joint resolution amending the Constitution is approved by two-thirds of both Houses, it is not presented to the President for approval. Following congressional approval, a joint resolution to amend the Constitution is sent directly to the Archivist of the United States for submission to the several states where ratification by the legislatures of three-fourths of the states within the period of time prescribed in the joint resolution is necessary for the amendment to become part of the Constitution. The form of a House joint resolution is as follows: JOINT RESOLUTION Authorizing, etc. [as the title may be]. Resolved by the Senate and House of Representatives of the United States of America in Congress assembled, That all, etc.

The resolving clause is identical in both House and Senate joint resolutions as prescribed by statute in 1871. It is frequently preceded by a preamble consisting of one or more ‘‘whereas’’ clauses indicating the necessity for or the desirability of the joint resolution.

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A joint resolution originating in the House of Representatives is designated ‘‘H.J. Res.’’ followed by its individual number, which it retains throughout all its parliamentary stages. One originating in the Senate is designated ‘‘S.J. Res.’’ followed by its number. Joint resolutions, with the exception of proposed amendments to the Constitution, become law in the same manner as bills. Concurrent Resolutions A matter affecting the operations of both Houses is usually initiated by a concurrent resolution. In modern practice, and as determined by the Supreme Court in INS v. Chadha, 462 U.S. 919 (1983), concurrent and simple resolutions normally are not legislative in character since not ‘‘presented’’ to the President for approval, but are used merely for expressing facts, principles, opinions, and purposes of the two Houses. A concurrent resolution is not equivalent to a bill and its use is narrowly limited within these bounds. The term ‘‘concurrent,’’ like ‘‘joint,’’ does not signify simultaneous introduction and consideration in both Houses. A concurrent resolution originating in the House of Representatives is designated ‘‘H. Con. Res.’’ followed by its individual number, while a Senate concurrent resolution is designated ‘‘S. Con. Res.’’ together with its number. On approval by both Houses, they are signed by the Clerk of the House and the Secretary of the Senate and transmitted to the Archivist of the United States for publication in a special part of the Statutes at Large volume covering that session of Congress. Simple Resolutions A matter concerning the rules, the operation, or the opinion of either House alone is initiated by a simple resolution. A resolution affecting the House of Representatives is designated ‘‘H. Res.’’ followed by its number, while a Senate resolution is designated ‘‘S. Res.’’ together with its number. Simple resolutions are considered only by the body in which they were introduced. On adoption, simple resolutions are attested to by the Clerk of the House of Representatives or the Secretary of the Senate and are published in the Congressional Record.

INTRODUCTION AND REFERRAL TO COMMITTEE Any Member, the Resident Commissioner from Puerto Rico, or the Delegates in the House of Representatives, may introduce a bill at any time while the House is in session by simply placing it in the ‘‘hopper,’’ a wooden box provided for that purpose located on the side of the rostrum in the House Chamber. Permission is not required to introduce the measure. Printed blank forms for an original bill are available through the Clerk’s office. The Member introducing the bill is known as the ‘‘sponsor.’’ An unlimited number of Members may cosponsor a bill. To prevent the possibility that a bill might be introduced in the House on behalf of a Member without

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that Member’s prior approval, the sponsor’s signature must appear on the bill before it is accepted for introduction. Members who cosponsor a bill upon its date of introduction are original cosponsors. Members who cosponsor a bill after its introduction are additional cosponsors. Cosponsors are not required to sign the bill. A Member may not be added or deleted as a cosponsor after the bill has been reported by the last committee authorized to consider it, but in no event shall the Speaker entertain a request to delete the name of the sponsor. In the Senate, unlimited multiple sponsorship of a bill is permitted. Occasionally, a Member may insert the words ‘‘by request’’ after the Member’s name to indicate that the introduction of the measure is at the suggestion of some other person or group. In the Senate, a Senator usually introduces a bill or resolution by presenting it to one of the clerks at the Presiding Officer’s desk, without commenting on it from the floor of the Senate. However, a Senator may use a more formal procedure by rising and introducing the bill or resolution from the floor. A Senator usually makes a statement about the measure when introducing it on the floor. Frequently, Senators obtain consent to have the bill or resolution printed in the body of the Congressional Record following their formal statement. If any Senator objects to the introduction of a bill or resolution, the introduction of the bill or resolution is postponed until the next day. If there is no objection, the bill is read by title and referred to the appropriate committee. In the House of Representatives, it is no longer the custom to read bills—even by title—at the time of introduction. The title is entered in the Journal and printed in the Congressional Record, thus preserving the purpose of the custom. The bill is assigned its legislative number by the Clerk. The bill is then referred as required by the rules of the House to the appropriate committee or committees by the Speaker, the Member elected by the Members to be the Presiding Officer of the House, with the assistance of the Parliamentarian. The bill number and committee referral appear in the next issue of the Congressional Record. It is then sent to the Government Printing Office, where it is printed in its introduced form and printed copies are made available in the document rooms of both Houses. Printed and electronic versions of the bill are also made available to the public. Copies of the bill are sent to the office of the chairman of the committee to which it has been referred. The clerk of the committee enters it on the committee’s Legislative Calendar. Perhaps the most important phase of the legislative process is the action by committees. The committees provide the most intensive consideration to a proposed measure as well as the forum where the public is given their opportunity to be heard. A tremendous volume of work, often overlooked by the public, is done by the Members in this phase. There are, at present, 19 standing committees in the House and 16 in the Senate as well as several select committees. In addition, there are four standing joint committees of the two Houses, that have oversight responsibilities but no legislative jurisdiction. The House may also create select committees or task forces to study specific issues and report on them to the House. A task force may be established formally through a resolution passed by the House or informally through an organization of interested Members and committees by the House leadership.

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Each committee’s jurisdiction is divided into certain subject matters under the rules of each House and all measures affecting a particular area of the law are referred to the committee with jurisdiction over the particular subject matter. For example, the Committee on the Judiciary in the House has jurisdiction over measures relating to judicial proceedings generally, and 17 other categories, including constitutional amendments, immigration and naturalization, bankruptcy, patents, copyrights, and trademarks. In total, the rules of the House and of the Senate each provide for over 200 different classifications of measures to be referred to committees. Until 1975, the Speaker of the House could refer a bill to only one committee. In modern practice, the Speaker may refer an introduced bill to multiple committees for consideration of those provisions of the bill within the jurisdiction of each committee concerned. The Speaker must designate a primary committee of jurisdiction on bills referred to multiple committees. The Speaker may place time limits on the consideration of bills by all committees, but usually time limits are placed only on additional committees. Additional committees are committees other than the primary committee to which a bill has been referred, either initially on its introduction or sequentially following the report of the primary committee. A time limit would be placed on an additional committee only when the primary committee has reported its version to the House. Membership on the various committees is divided between the two major political parties. The proportion of the Members of the minority party to the Members of the majority party is determined by the majority party, except that half of the members on the Committee on Standards of Official Conduct are from the majority party and half from the minority party. The respective party caucuses nominate Members of the caucus to be elected to each standing committee at the beginning of each Congress. Membership on a standing committee during the course of a Congress is contingent on continuing membership in the party caucus that nominated the Member for election to the committee. If the Member ceases to be a Member of the party caucus, the Member automatically ceases to be a member of the standing committee. Members of the House may serve on only two committees and four subcommittees with certain exceptions. However, the rules of the caucus of the majority party in the House provide that a Member may be chairman of only one subcommittee of a committee or select committee with legislative jurisdiction, except for certain committees performing housekeeping functions and joint committees. A Member usually seeks election to the committee that has jurisdiction over a field in which the Member is most qualified and interested. For example, the Committee on the Judiciary traditionally is composed almost entirely of lawyers. Many Members are nationally recognized experts in the specialty of their particular committee or subcommittee. Members rank in seniority in accordance with the order of their appointment to the full committee and the ranking majority member with the most continuous service is usually elected chairperson. The rules of the House require that committee chairpersons be elected from nominations submitted by the majority party caucus at the commencement of each Congress. No Member of the House may serve as

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chairman of the same standing committee or of the same subcommittee thereof for more than three consecutive Congresses. The rules of the House prohibit a committee that maintains a subcommittee on oversight from having more than six subcommittees with the exception of the Committee on Appropriations and the Committee on Government Reform. Each committee is provided with a professional staff to assist it in the innumerable administrative details involved in the consideration of bills and its oversight responsibilities. For standing committees, the professional staff is limited to 30 persons appointed by a vote of the committee. Two-thirds of the committee staff are selected by a majority vote of the majority committee members and one-third of the committee staff are selected by a majority vote of minority committee members. All staff appointments are made without regard to race, creed, sex, or age. The minority staff provisions do not apply to the Committee on Standards of Official Conduct because of its bipartisan nature. The Committee on Appropriations has special authority under the rules of the House for appointment of staff for the minority.

CONSIDERATION BY COMMITTEE One of the first actions taken by a committee is to seek the input of the relevant departments and agencies. Frequently, the bill is also submitted to the General Accounting Office with a request for an official report of views on the necessity or desirability of enacting the bill into law. Normally, ample time is given for the submission of the reports and they are accorded serious consideration. However, these reports are not binding on the committee in determining whether or not to act favorably on the bill. Reports of the departments and agencies in the executive branch are submitted first to the Office of Management and Budget to determine whether they are consistent with the program of the President. Many committees adopt rules requiring referral of measures to the appropriate subcommittee unless the full committee votes to retain the measure at the full committee. Committee Meetings Standing committees are required to have regular meeting days at least once a month. The chairman of the committee may also call and convene additional meetings. Three or more members of a standing committee may file with the committee a written request that the chairman call a special meeting. The request must specify the measure or matter to be considered. If the chairman fails to call the requested special meeting within three calendar days after the filing of the request, to be held within seven calendar days after the filing of the request, a majority of the members of the committee may call the special meeting by filing with the committee written notice specifying the date, hour, and the measure or matter to be considered. In the Senate, the Chair may still control the agenda of the special meeting through the power of recognition. Committee meetings may be held for various purposes including the

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‘‘markup’’ of legislation, authorizing subpoenas, or internal budget and personnel matters. A subpoena may be authorized and issues at a meeting by a vote of a committee or subcommittee with a majority of members present. The power to authorize and issue subpoenas also may be delegated to the chairman of the committee. A subpoena may require both testimonial and documentary evidence to be furnished to the committee. A subpoena is signed by the chairman of the committee or by a member designated by the committee. All meetings for the transaction of business of standing committees or subcommittees, except the Committee on Standards of Official Conduct, must be open to the public, except when the committee or subcommittee, in open session with a majority present, determines by record vote that all or part of the remainder of the meeting on that day shall be closed to the public. Members of the committee may authorize congressional staff and departmental representatives to be present at any meeting that has been closed to the public. Open committee meetings may be covered by the media. Permission to cover hearings and meetings is granted under detailed conditions as provided in the rules of the House. The rules of the House provide that House committees may not meet during a joint session of the House and Senate or during a recess when a joint meeting of the House and Senate is in progress. Committees may meet at other times during an adjournment or recess up to the expiration of the constitutional term. Public Hearings If the bill is of sufficient importance, the committee may set a date for public hearings. Each committee, except for the Committee on Rules, is required to make public announcement of the date, place, and subject matter of any hearing to be conducted by the committee on any measure or matter at least one week before the commencement of that hearing, unless the committee chairman with the concurrence of the ranking minority member or the committee by majority vote determines that there is good cause to begin the hearing at an earlier date. If that determination is made, the chairman must make a public announcement to that effect at the earliest possible date. Public announcements are published in the ‘‘Daily Digest’’ portion of the Congressional Record as soon as possible after the announcement is made and are often noted by the media. Personal notice of the hearing, usually in the form of a letter, is sometimes sent to relevant individuals, organizations, and government departments and agencies. Each hearing by a committee and subcommittee, except the Committee on Standards of Official Conduct, is required to be open to the public except when the committee or subcommittee, in open session and with a majority present, determines by record vote that all or part of the remainder of the hearing on that day shall be closed to the public because disclosure of testimony, evidence, or other matters to be considered would endanger the national security, would compromise sensitive law enforcement information, or would violate a law or a rule of the House. The committee or subcommittee by the same procedure may vote to close one subsequent day of

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hearing, except that the Committees on Appropriations, Armed Services, and the Permanent Select Committee on Intelligence, and subcommittees thereof, may vote to close up to five additional consecutive days of hearings. When a quorum for taking testimony is present, a majority of the members present may close a hearing to discuss whether the evidence or testimony to be received would endanger national security or would tend to defame, degrade, or incriminate any person. A committee or subcommittee may vote to release or make public matters originally received in a closed hearing or meeting. Open committee hearings may be covered by the media. Permission to cover hearings and meetings is granted under detailed conditions as provided in the rules of the House. Hearings on the Budget are required to be held by the Committee on Appropriations in open session within 30 days after its transmittal to Congress, except when the committee, in open session and with a quorum present, determines by record vote that the testimony to be taken at that hearing on that day may be related to a matter of national security. The committee may by the same procedure close one subsequent day of hearing. On the day set for the public hearing in a committee or subcommittee, an official reporter is present to record the testimony. After a brief introductory statement by the chairman and often by the ranking minority member or other committee member, the first witness is called. Members or Senators who wish to be heard sometimes testify first out of courtesy and because of the limitations on their time. Cabinet officers and high-ranking civil and military officials of the government, as well as interested private individuals, testify either voluntarily or by subpoena. As far as practicable, committees require that witnesses who appear before it file a written statement of their proposed testimony in advance of their appearance and limit their oral presentations to a brief summary of their arguments. In the case of a witness appearing in a nongovernmental capacity, a written statement of proposed testimony shall include a curriculum vitae and a disclosure of certain federal grants and contracts. Minority party members of the committee are entitled to call witnesses of their own to testify on a measure during at least one day of the hearing. Each member is provided only 5 minutes in the interrogation of each witness until each member of the committee who desires to question a witness has had an opportunity to do so. In addition, a committee may adopt a rule or motion to permit committee members to question a witness for a specified period not longer than one hour. Committee staff may also be permitted to question a witness for a specified period not longer than one hour. A transcript of the testimony taken at a public hearing is made available for inspection in the office of the clerk of the committee. Frequently, the complete transcript is printed and distributed widely by the committee. Markup After hearings are completed, the subcommittee usually will consider the bill in a session that is popularly known as the ‘‘markup’’ session. The views of both sides are

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studied in detail and at the conclusion of deliberation a vote is taken to determine the action of the subcommittee. It may decide to report the bill favorably to the full committee, with or without amendment, or unfavorably, or without recommendation. The subcommittee may also suggest that the committee ‘‘table’’ it or postpone action indefinitely. Each member of the subcommittee, regardless of party affiliation, has one vote. Proxy voting is no longer permitted in House committees. Final Committee Action At full committee meetings, reports on bills may be made by subcommittees. Bills are read for amendment in committees by section, and members may offer germane amendments. Committee amendments are only proposals to change the bill as introduced and are subject to acceptance or rejection by the House itself. A vote of committee members is taken to determine whether the full committee will report favorably or table the bill. If the committee votes to report the bill favorably to the House, it may report the bill without amendments or introduce and report a ‘‘clean bill.’’ If the committee has approved extensive amendments, the committee may decide to report the original bill with one ‘‘amendment in the nature of a substitute’’ consisting of all the amendments previously adopted, or may report a new bill incorporating those amendments, commonly known as a clean bill. The new bill is introduced (usually by the chairperson of the committee), and, after referral back to the committee, is reported favorably to the House by the committee. A committee may table a bill or not take action on it, thereby preventing further action on a bill. This makes adverse reports to the House by a committee unusual. On rare occasions, a committee may report a bill without recommendation or adversely. The House also has the ability to discharge a bill from committee. Generally, a majority of the committee or subcommittee constitutes a quorum, which is the number of members who must be present in order for the committee to report. This ensures participation by both sides in the action taken. However, a committee may vary the number of members necessary for a quorum for certain actions. For example, a committee may fix the number of its members, but not less than two, necessary for a quorum for taking testimony and receiving evidence. Except for the Committees on Appropriations, the Budget, and Ways and Means, a committee may fix the number of its members, but not less than one-third, necessary for a quorum for taking certain other actions. The absence of a quorum is subject to a point of order, an objection that the proceedings are in violation of a rule of the committee or of the House, because the required number of members are not present. Points of Order with Respect to Committee Hearing Procedure A point of order in the House does not lie with respect to a measure reported by a committee on the grounds that hearings on the measure were not conducted in accordance with required committee procedure. However, certain points of order may be made by a member of the committee that reported the measure if, in the

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committee hearing on that measure, that point of order was (1) timely made and (2) improperly disposed of.

REPORTED BILLS If the committee votes to report the bill to the House, the committee staff writes the committee report. The report describes the purpose and scope of the bill and the reasons for its recommended approval. Generally, a section-by-section analysis is set forth explaining precisely what each section is intended to accomplish. All changes in existing law must be indicated in the report and the text of laws being repealed must be set out. This requirement is known as the ‘‘Ramseyer rule.’’ A similar rule in the Senate is known as the ‘‘Cordon rule.’’ Committee amendments also must be set out at the beginning of the report and explanations of them are included. Executive communications regarding the bill may be referenced in the report. If at the time of approval of a bill by a committee, except the Committee on Rules, a member of the committee gives notice of an intention to file supplemental, minority, or additional views, that member is entitled to not less than two additional calendar days after the day of such notice (excluding Saturdays, Sundays, and legal holidays unless the House is in session on those days) in which to file those views with the clerk of the committee. Those views that are filed in a timely manner must be included in the report on the bill. Committee reports must be filed while the House is in session unless unanimous consent is obtained from the House to file at a later time or the committee is awaiting additional views. The report is assigned a report number on its filing and is sent to the Government Printing Office for printing. House reports are assigned the prefix designator, which indicates the number of the Congress. For example, the first House report in the 106th Congress was numbered 106-1. In the printed report, committee amendments are indicated by showing new matter in italics and deleted matter in line-through type. The report number is printed on the bill and the calendar number is shown on both the first and back pages of the bill. However, in the case of a bill that was referred to two or more committees for consideration in sequence, the calendar number is printed only on the bill as reported by the last committee to consider it. Committee reports are perhaps the most valuable single element of the legislative history of a law. They are used by courts, executive departments, and the public as a source of information regarding the purpose and meaning of the law. Contents of Reports The report of a committee on a measure that has been approved by the committee must include (1) the committee’s oversight findings and recommendations; (2) a statement required by the Congressional Budget Act of 1974, if the measure is a bill or joint resolution providing new budget authority (other than continuing appropriations) or an increase or decrease in revenues or tax expenditures; (3) a cost

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estimate and comparison prepared by the Director of the Congressional Budget Office whenever the Director has submitted that estimate and comparison to the committee prior to the filing of the report; and (4) a summary of the oversight findings and recommendations made by the Committee on Government Reform whenever they have been submitted to the reporting committee in a timely fashion to allow an opportunity to consider the findings and recommendations during the committee’s deliberations on the measure. Each report accompanying a bill or joint resolution related to employment or access to public services or accommodations must describe the manner in which the provisions apply to the legislative branch. Each of these items are set out separately and clearly identified in the report. With respect to each record vote by a committee, the total number of votes cast for, and the total number of votes cast against any public measure or matter or amendment thereto and the names of those voting for and against, must be included in the committee report. In addition, each report of a committee on a public bill or public joint resolution must contain a statement citing the specific powers granted to Congress in the Constitution to enact the law proposed by the bill or joint resolution. Committee reports that accompany bills or resolutions that contain federal unfunded mandates are also required to include an estimate prepared by the Congressional Budget Office on the cost of the mandates on state, local, and tribal governments. If an estimate is not available at the time a report is filed, committees are required to publish the estimate in the Congressional Record. Each report also must contain an estimate, made by the committee, of the costs that would be incurred in carrying out that bill or joint resolution in the fiscal year reported and in each of the five fiscal years thereafter or for the duration of the program authorized if less than 5 years. The report must include a comparison of the estimates of those costs with the estimate made by any government agency and submitted to that committee. The Committees on Appropriations, on House Administration, Rules, and Standards of Official Conduct are not required to include cost estimates in their reports. In addition, the committee’s own cost estimates are not required to be included in reports when a cost estimate and comparison prepared by the Director of the Congressional Budget Office has been submitted prior to the filing of the report and included in the report. Filing of Reports Measures approved by a committee must be reported promptly after approval. A majority of the members of the committee may file a written request with the clerk of the committee for the reporting of the measure. When the request is filed, the clerk must immediately notify the chairperson of the committee of the filing of the request, and the report on the measure must be filed within 7 days (excluding days on which the House is not in session) after the day on which the request is filed. This does not apply to a report of the Committee on Rules with respect to the rule, joint rule, or order of business of the House or to the reporting of a resolution of inquiry addressed to the head of an executive department.

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Availability of Reports and Hearings A measure or matter reported by a committee (except the Committee on Rules in the case of a resolution providing a rule, joint rule, or other order of business) may not be considered in the House until the third calendar day (excluding Saturdays, Sundays, and legal holidays unless the House is in session on those days) on which the report of that committee on that measure has been available to the Members of the House. This rule is subject to certain exceptions, including resolutions providing for certain privileged matters, measures declaring war or other national emergency, and government agency decisions, determinations, and actions that are effective unless disapproved or otherwise invalidated by one or both Houses of Congress. However, it is always in order to consider a report from the Committee on Rules specifically providing for the consideration of a reported measure or matter notwithstanding this restriction. If hearings were held on a measure or matter so reported, the committee is required to make every reasonable effort to have those hearings printed and available for distribution to the Members of the House prior to the consideration of the measure in the House. Committees are also required, to the maximum extent feasible, to make their publications available in electronic form. General appropriation bills may not be considered until printed committee hearings and a committee report thereon have been available to the Members of the House for at least three calendar days (excluding Saturdays, Sundays, and legal holidays unless the House is in session on those days).

LEGISLATIVE OVERSIGHT BY STANDING COMMITTEES Each standing committee, other than the Committees on Appropriations and on the Budget, is required to review and study, on a continuing basis, the application, administration, execution, and effectiveness of the laws dealing with the subject matter over which the committee has jurisdiction and the organization and operation of federal agencies and entities having responsibility for the administration and evaluation of those laws. The purpose of the review and study is to determine whether laws and the programs created by Congress are being implemented and carried out in accordance with the intent of Congress and whether those programs should be continued, curtailed, or eliminated. In addition, each committee having oversight responsibility is required to review and study any conditions or circumstances that may indicate the necessity or desirability of enacting new or additional legislation within the jurisdiction of that committee, and must undertake, on a continuing basis, future research and forecasting on matters within the jurisdiction of that committee. Each standing committee also has the function of reviewing and studying, on a continuing basis, the impact or probable impact of tax policies on subjects within its jurisdiction. The rules of the House provide for special treatment of an investigative or oversight report of a committee. Committees are allowed to file joint investigative and activities reports and to file investigative and activities reports after the House has

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completed its final session of a Congress. In addition, several of the standing committees have special oversight responsibilities. The details of those responsibilities are set forth in the rules of the House.

CALENDARS The House of Representatives has five calendars of business: the Union Calendar, the House Calendar, the Private Calendar, the Corrections Calendar, and the Calendar of Motions to Discharge Committees. The calendars are compiled in one publication printed each day the House is in session. This publication also contains a history of Senate-passed bills, House bills reported out of committee, bills on which the House has acted, as well as other useful information. When a public bill is favorably reported by all committees to which referred, it is assigned a calendar number on either the Union Calendar or the House Calendar, the two principal calendars of business. The calendar number is printed on the first page of the bill and, in certain instances, is printed also on the back page. In the case of a bill that was referred to multiple committees for consideration in sequence, the calendar number is printed only on the bill as reported by the last committee to consider it. Union Calendar The rules of the House provide that there shall be ‘‘a Calendar of the Committee of the Whole House on the state of the Union, to which shall be referred public bills and public resolutions raising revenue, involving a tax or charge on the people, directly or indirectly making appropriations of money or property or requiring such appropriations to be made, authorizing payments out of appropriations already made, releasing any liability to the United States for money or property, or referring a claim to the Court of Claims.’’ The large majority of public bills and resolutions reported to the House are placed on the Union Calendar. House Calendar The rules further provide that there shall be ‘‘a House Calendar, to which shall be referred all public bills and public resolutions not requiring referral to the Calendar of the Committee of the Whole House on the state of the Union.’’ Private Calendar The rules also provide that there shall be ‘‘a Private Calendar . . . to which shall be referred all private bills and private resolutions.’’ All private bills reported to the House are placed on the Private Calendar. The Private Calendar is called on the first and third Tuesdays of each month. If two or

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more Members object to the consideration of any measure called, it is recommitted to the committee that reported it. There are six official objectors, three on the majority side and three on the minority side, who make a careful study of each bill or resolution on the Private Calendar. The official objectors’ role is to object to a measure that does not conform to the requirements for that calendar and prevent the passage without debate of nonmeritorious bills and resolutions. Private bills that have been reported from committee are only considered under the calendar procedure. Alternative procedures reserved for public bills are not applicable for reported private bills.

Corrections Calendar If a measure pending on either the House or Union Calendar is of a noncontroversial nature, it may be placed on the Corrections Calendar. The Corrections Calendar was created to address specific problems with federal rules, regulations, or court decisions that bipartisan and narrowly targeted bills could expeditiously correct. After a bill has been favorably reported and is on either the House or Union Calendar, the Speaker may, after consultation with the Minority Leader, file with the Clerk a notice requesting that such bill also be placed on a special calendar known as the Corrections Calendar. On the second and fourth Tuesdays of each month, the Speaker directs the Clerk to call any bill that has been on the Corrections Calendar for 3 legislative days. A three-fifths vote of the Members voting is required to pass any bill called from the Corrections Calendar. A failure to adopt a bill from the Corrections Calendar does not necessarily mean the final defeat of the bill because it may then be brought up for consideration in the same way as any other bill on the House or Union Calendar.

Calendar of Motions to Discharge Committees When a majority of the Members of the House sign a motion to discharge a committee from consideration of a public bill or resolution, that motion is referred to the Calendar of Motions to Discharge Committees.

OBTAINING CONSIDERATION OF MEASURES Certain measures, either pending on the House and Union Calendars or unreported and pending in committee, are more important and urgent than others, and a system permitting their consideration ahead of those that do not require immediate action is necessary. If the calendar numbers alone were the determining factor, the bill reported most recently would be the last to be taken up as all measures are placed on the House and Union Calendars in the order reported.

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Unanimous Consent The House occasionally employs the practice of allowing reported or unreported measures to be considered by the unanimous agreement of all Members in the House Chamber. The power to recognize Members for a unanimous consent request is ultimately in the discretion of the Chair, but recent (as of 2002) Speakers have issued strict guidelines on when such a request is to be entertained. Most unanimous consent requests for consideration of measures may only be entertained by the Chair when assured that the majority and minority floor and committee leaderships have no objection. Special Resolution or ‘‘Rule’’ To avoid delays and to allow selectivity in the consideration of public measures, it is possible to have them taken up out of their order on their respective calendar or to have them discharged from the committee or committees to which referred by obtaining from the Committee on Rules a special resolution or ‘‘rule’’ for their consideration. The Committee on Rules, which is composed of majority and minority members but with a larger proportion of majority members than other committees, is specifically granted jurisdiction over resolutions relating to the order of business of the House. Typically, the chairperson of the committee that has favorably reported the bill requests the Committee on Rules to originate a resolution that will provide for its immediate or subsequent consideration. Under unusual circumstances, the Committee on Rules may originate a resolution providing for the ‘‘discharge’’ and consideration of a measure that has not been reported by the legislative committee of committees of jurisdiction. If the Committee on Rules has determined that the measure should be taken up, it may report a resolution reading substantially as follows with respect to a bill on the Union Calendar or an unreported bill: Resolved, That upon the adoption of this resolution the Speaker declares pursuant to rule XVIII that the House resolve itself into the Committee of the Whole House on the State of the Union for the consideration of the bill (H.R. —) entitled, etc., and the first reading of the bill shall be dispensed with. After general debate, which shall be confined to the bill and shall continue not to exceed — hours, to be equally divided and controlled by the chairman and ranking minority member of the Committee on —, the bill shall be read for amendment under the five-minute rule. At the conclusion of the consideration of the bill for amendment, the Committee shall rise and report the bill to the House with such amendments as may have been adopted, and the previous question shall be considered as ordered on the bill and amendments thereto to final passage without intervening motion except one motion to recommit with or without instructions.

If the measure is on the House Calendar or the recommendation is to avoid consideration in the Committee of the Whole, the resolution reads substantially as follows: ‘‘Resolved, That upon the adoption of this resolution it shall be in order to consider the bill (H.R. —) entitled, etc., in the House.’’

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The resolution may waive points of order against the bill. A point of order is an objection that a pending matter or proceeding is in violation of a rule of the House. The bill may be susceptible to various points of order that may be made against its consideration, including an assertion that the bill carries a retroactive federal income tax increase, contains a federal unfunded mandate, or has not been reported from committee properly. When a rule limits or prevents floor amendments, it is popularly known as a ‘‘closed rule’’ or ‘‘modified closed rule.’’ However, a special resolution may not deny the minority party the right to offer a motion to recommit the bill with amendatory or general instructions.

Consideration of Measures Made in Order by Rule Reported from the Committee on Rules When a rule has been reported to the House and is not considered immediately, it is referred to the calendar and, if not called up for consideration by the person who filed the report 7 seven legislative days thereafter, any member of the Committee on Rules may call it up as a privileged matter, after giving one calendar day notice of the Member’s intention to do so. The Speaker will recognize any member of the committee seeking recognition for that purpose. If the House has adopted a resolution making in order a motion to consider a bill, and such a motion has not been offered within 7 calendar days thereafter, such a motion shall be privileged if offered by direction of all reporting committees having initial jurisdiction of the bill. There are several other methods of obtaining consideration of bills that either have not been reported by a committee or, if reported, for which a rule has not been granted. Two of those methods, a motion to discharge a committee and a motion to suspend the rules, are discussed below.

Motion to Discharge Committee A Member (of the House) may present to the Clerk a motion in writing to discharge a committee from the consideration of a public bill or resolution that has been referred to it 30 days prior thereto. A Member also may file a motion to discharge the Committee on Rules from further consideration of a resolution providing a special rule for the consideration of a public bill or resolution reported by a standing committee, or a special rule for the consideration of a public bill or resolution that has been referred to a standing committee for 30 legislative days. This motion to discharge the Committee on Rules may be made only when the resolution has been referred to that committee at least 7 legislative days prior to the filing of the motion to discharge. The motion may not permit consideration of nongermane amendments. The motion is placed in the custody of the Journal Clerk, where Members may sign it at the House rostrum only when the House is in session. The names of Members who have signed a discharge motion are available electronically or published in the Congressional Record on a weekly basis. When a majority of the total membership of the House (218 Members) have signed the motion, it is entered in the Journal,

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printed with all the signatures thereto in the Congressional Record, and referred to the Calendar of Motions to Discharge Committees. On the second and fourth Mondays of each month, except during the last 6 days of a session, a Member who has signed a motion to discharge that has been on the calendar for at least 7 legislative days may seek recognition and be recognized for the purpose of calling up the motion. The motion to discharge is debated for 20 minutes, one-half in favor of the proposition and one-half opposed. If the motion to discharge the Committee on Rules from a resolution prevails, the House shall immediately consider such resolution. If the resolution is adopted, the House proceeds to its execution. This is the modern practice for utilization of the discharge rule. If the motion to discharge a standing committee of the House from a public bill or resolution pending before the committee prevails, a Member who signed the motion may move that the House proceed to the immediate consideration of the bill or resolution. If the motion is agreed to, the bill or resolution is considered immediately under the general rules of the House. If the House votes against the motion for immediate consideration, the bill or resolution is referred to its proper calendar with the same status as if reported favorably by a standing committee.

Motion to Suspend the Rules On Monday and Tuesday of each week and during the last 6 days of a session, the Speaker may entertain a motion to suspend the rules of the House and pass a public bill or resolution. Members need to arrange in advance with the Speaker to be recognized to offer such a motion. The Speaker usually recognizes only a major member of the committee that has reported or has primary jurisdiction over the bill. The motion to suspend the rules and pass the bill is debatable for 40 minutes, onehalf of the time in favor of the proposition and one-half in opposition. The motion may not be separately amended but may be amended in the form of a manager’s amendment included in the motion when it is offered. Because the rules may be suspended and the bill passed only by affirmative vote of two-thirds of the Members voting, with a quorum present, this procedure is usually used only for expedited consideration of relatively noncontroversial public measures. The Speaker may postpone all recorded and yea=nay votes on certain questions before the House, including a motion to suspend the rules and the passage of bills and resolutions, until a specified time on that legislative day or the next two legislative days. At that time, the House disposes of the postponed votes consecutively without further debate. After an initial 15-minute vote is taken, the Speaker may reduce the time period for subsequent votes to not less than 5 minutes. If the House adjourns before completing action on postponed votes, the postponed votes must be the first order of business on the next legislative day. Eliminating intermittent recorded votes on suspensions reduces interruptions of committee activity and allows more efficient scheduling of voting.

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Calendar Wednesday On Wednesday of each week, unless dispensed with by unanimous consent or by affirmative vote of two-thirds of the Members voting, with a quorum present, the standing committees are called in alphabetical order. A committee when named may call up for consideration any bill reported by it on a previous day and pending on either the House or Union Calendar. The report on the bill must have been available for 3 days and must not be privileged under the rules of the House. General debate is limited to 2 hours on any Calendar Wednesday measure and must be confined to the subject matter of the measure, with the time equally divided between those for and those against it. An affirmative vote of a simple majority of the Members present is sufficient to pass the measure. The purpose of this rarely utilized procedure is to provide an alternative method of consideration when the Committee on Rules has not reported a rule for a specific bill. District of Columbia Business On the second and fourth Mondays of each month, after the disposition of motions to discharge committees and after the disposal of business on the Speaker’s table requiring only referral to committee, the Committee on Government Reform may call up for consideration any District of Columbia business reported from that committee. Questions of Privilege House rules provide special privilege to questions of privilege. Questions of privilege are classified as those affecting (1) the rights of the House collectively, including its safety, dignity, and the integrity of its proceedings, and (2) the rights, reputations, and conduct of Members, individually, in their representative capacity. A question of privilege has been held to take precedence over all questions except the motion to adjourn. Questions of the privileges of the House, those concerning the rights of the House collectively, take the form of a resolution that may be called up by any Member after proper notice. A question of personal privilege, affecting the rights, reputation, and conduct of individual Members, may be raised from the floor without formal notice. Debate on a question of privilege proceeds under the hour rule, with debate on a question of the privileges of the House divided between the proponent and the leader of the opposing party or a designee. Privileged Matters Under the rules of the House, certain matters are regarded as privileged matters and may interrupt the order of business. Conference reports, veto messages from the President, and certain amendments to measures by the Senate after the stage of disagreement between the two Houses are examples of privileged matters. Certain reports from House committees are also privileged, including reports from the

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Committee on Rules, reports from the Committee on Appropriations on the general appropriation bills, printing and committee funding resolutions reported from the Committee on House Administration, and reports on Members’ conduct from the Committee on Standards of Official Conduct. Bills, joint resolutions, and motions may also take on privileged status as a result of special procedures written into statute. The Member in charge of such a matter may call it up at practically any time for immediate consideration when no other business is pending. Usually, this is done after consultation with both the majority and minority floor leaders so that the Members of both parties will have advance notice. At any time after the reading of the Journal, a Member, by direction of the Committee on Appropriations, may move that the House resolve itself into the Committee of the Whole House on the State of the Union for the purpose of considering general appropriation bills. A general appropriation bill may not be considered in the House until 3 calendar days (excluding Saturdays, Sundays, and legal holidays unless the House is in session on those days) after printed committee reports and hearings on the bill have been available to the Members. The limit on general debate on such a bill is generally fixed by a rule reported from the Committee on Rules.

CONSIDERATION AND DEBATE Our democratic tradition demands that bills be given consideration by the entire membership usually with adequate opportunity for debate and the proposing of amendments. Committee of the Whole House In order to expedite the consideration of bills and resolutions, the rules of the House provide for a parliamentary mechanism, known as the Committee of the Whole House on the state of the Union, that enables the House to act with a quorum of less than the requisite majority of 218. A quorum in the Committee of the Whole is 100 members. All measures on the Union Calendar—those involving a tax, making appropriations, authorizing payments out of appropriations already made, or disposing of property—must be first considered in the Committee of the Whole. The Committee on Rules reports a rule allowing for immediate consideration of a measure by the Committee of the Whole. After adoption of the rule by the House, the Speaker may declare the House resolved into the Committee of the Whole. When the House resolves into the Committee of the Whole, the Speaker leaves the chair after appointing a Chairperson to preside. The rule referred to in the preceding paragraph also fixes the length of the debate in the Committee of the Whole. This may vary according to the importance of the measure. As provided in the rule, the control of the time is usually divided equally between the Chairperson and the ranking minority member of the relevant committee. Members seeking to speak for or against the measure may arrange in advance

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with the Member in control of the time on their respective side to be allowed a certain amount of time in the debate. Members may also ask the Member speaking at the time to yield to them for a question or a brief statement. A transcript of the proceedings in the House and the Senate is printed daily in the Congressional Record. Frequently, permission is granted a Member by unanimous consent to revise and extend his remarks in the Congressional Record if sufficient time to make a lengthy oral statement is not available during actual debate. These revisions and extensions are printed in a distinctive type and cannot substantively alter the verbatim transcript. The conduct of the debate is governed principally by the rules of the House that are adopted at the opening of each Congress. Jefferson’s Manual, prepared by Thomas Jefferson for his own guidance as President of the Senate from 1797 to 1801, is another recognized authority. The House has a longstanding rule that the provisions of Jefferson’s Manual govern the House in all applicable cases and where they are not inconsistent with the rules of the House. The House also relies on an 11volume compilation of parliamentary precedents, entitled Hinds’ Precedents and Cannon’s Precedents of the House of Representatives, dating from 1789 to 1935, to guide its action. A later compilation, Deschler–Brown Precedents of the House of Representatives, spans 15 volumes and covers 1936 to date (2002). In addition, a summary of the House precedents prior to 1959 can be found in a single volume entitled Cannon’s Procedure in the House of Representatives. Procedure in the U.S. House of Representatives, fourth edition, as supplemented, and House Practice, published in 1996, are more recent compilations of the precedents of the House, in summary form, together with other useful related material. Also, various rulings of the Chair are set out as notes in the current House Rules and Manual. Most parliamentary questions arising during the course of debate are responded to by a ruling based on a precedent of action in a similar situation. The Parliamentarian of the House is present in the House Chamber in order to assist the Speaker or the Chairperson in making a correct ruling on parliamentary questions. Second Reading During general debate on a bill, an accurate account of the time used on both sides is kept and the Chairperson terminates the debate when all the time allowed under the rule has been consumed. After general debate, the second reading of the bill begins. The second reading is a section-by-section reading during which time germane amendments may be offered to a section when it is read. Under some special ‘‘modified closed’’ rules adopted by the House, certain bills are considered as read and open only to prescribed amendments under limited time allocations. Under the normal ‘‘open’’ amendment process, a Member is permitted five minutes to explain the proposed amendment, after which the Member who is first recognized by the Chair is allowed to speak for 5 minutes in opposition to it. There is no further debate on that amendment, thereby effectively preventing filibuster-like tactics. This is known as the ‘‘5-minute rule.’’ However, Members may offer an amendment to the amendment, for separate five-minute debate, or may offer a pro forma

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amendment—‘‘to strike out the last word’’—which does not change the language of the amendment but allows the Member 5 minutes for debate. Each substantive amendment and amendment thereto is put to the Committee of the Whole for adoption unless the House has adopted a special rule ‘‘self-executing’’ the adoption of certain amendments in the Committee of the Whole. At any time after debate has begun on proposed amendments to a section or paragraph of a bill under the 5-minute rule, the Committee of the Whole may by majority vote of the Members present close debate on the section or paragraph. However, if debate is closed on a section or paragraph before there has been debate on an amendment that a Member has caused to be printed in the Congressional Record at least one day prior to floor consideration of the amendment, the Member who caused the amendment to be printed in the Record is given five minutes in which to explain the amendment. Five minutes is also given to speak in opposition to the amendment and no further debate on the amendment is allowed. Amendments placed in the Congressional Record must indicate the full text of the proposed amendment, the name of the Member proposing it, the number of the bill or amendment to which it will be offered, and the point in the bill or amendment thereto where the amendment is intended to be offered. These amendments appear in the portion of the Record designated for that purpose. Amendments and the Germaneness Rule The rules of the House prohibit amendments of a subject matter different from the text under consideration. This rule, commonly known as the ‘‘germaneness rule,’’ is considered the single most important rule of the House of Representatives because of the obvious need to keep the focus of a body the size of the House on a predictable subject matter. The germaneness rule applies to the proceedings in the House, the Committee of the Whole, and the standing committees. There are hundreds of prior rulings or ‘‘precedents’’ on issues of germaneness available to guide the Chair. The Committee ‘‘Rises’’ At the conclusion of the consideration of a bill for amendment, the Committee of the Whole ‘‘rises’’ and reports the bill to the House with the amendments that have been adopted. In rising, the Committee of the Whole reverts back to the House and the Chairman of the Committee is replaced in the chair by the Speaker of the House. The House then acts on the bill and any amendments adopted by the Committee of the Whole. House Action Debate on a bill in the House is cut off by moving and ordering ‘‘the previous question.’’ All debate is cut off on the bill if this motion is carried by a majority of the Members voting, with a quorum present, or by a special rule ordering the

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previous question on the rising of the Committee of the Whole. The Speaker then poses the following question: ‘‘Shall the bill be engrossed and read a third time?’’ If this question is decided in the affirmative, the bill is read a third time by title only and voted on for passage. If the previous question has been ordered by the terms of the rule on a bill reported by the Committee of the Whole, the House immediately votes on whatever amendments have been reported by the Committee in the order in which they appear in the bill unless voted on en bloc. After completion of voting on the amendments, the House immediately votes on the passage of the bill with the amendments it has adopted. However, a motion to recommit, as described in the next section, may be offered and voted on prior to the vote on passage. The Speaker may postpone a recorded vote on final passage of a bill or resolution or agreement to a conference report for up to two legislative days. Measures that do not have to be considered in the Committee of the Whole are considered in the House in accordance with the terms of the rule limiting debate on the measure or under the ‘‘hour rule.’’ The hour rule limits the amount of time that a Member may occupy in debate on a pending question to 60 minutes. Generally, the opportunity for debate may also be curtailed when the Speaker makes the rare determination that a motion is dilatory. After passage or rejection of the bill by the House, a pro forma motion to reconsider it is automatically made and laid on the table. The motion to reconsider is tabled to prohibit this motion from being made at a later date because the vote of the House on a proposition is not final and conclusive until there has been an opportunity to reconsider it. Motion to Recommit After the previous question has been ordered on the passage of a bill or joint resolution, it is in order to offer one motion to recommit the bill or joint resolution to a committee and the Speaker is required to give preference in recognition for that purpose to a minority party Member who is opposed to the bill or joint resolution. This motion is normally not subject to debate. However, a motion to recommit with instructions offered after the previous question has been ordered is debatable for 10 minutes, except that the majority floor manager may demand that the debate be extended to one hour. Whatever time is allotted for debate is divided equally between the proponent and opponent of the motion. Instructions in the motion to recommit normally take the form of germane amendments proposed by the minority to immediately change the final form of the bill prior to passage. Instructions may also be ‘‘general,’’ directing the committee to take specified actions such as to review the bill with a particular political viewpoint or to hold further hearings. Quorum Calls and Roll Calls Article 1, Section 5, of the Constitution provides that a majority of each House constitutes a quorum to do business and authorizes a smaller number than a quorum

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to compel the attendance of absent Members. In order to fulfill this constitutional responsibility, the rules of the House provide alternative procedures for quorum calls in the House and the Committee of the Whole. In the absence of a quorum, 15 Members may initiate a call of the House to compel the attendance of absent Members. Such a call of the House must be ordered by a majority vote. A call of the House is then ordered, and the call is taken by electronic device or by response to the alphabetical roll call of Members. Absent Members have a minimum of 15 minutes from the ordering of the call of the House by electronic device to have their presence recorded. If sufficient excuse is not offered for their absence, they may be sent for by the Sergeant-at-Arms and their attendance secured and retained. The House then determines the conditions on which they may be discharged. Members who voluntarily appear are, unless the House otherwise directs, immediately admitted to the Hall of the House and must report their names to the Clerk to be entered in the Journal as present. Compulsory attendance or arrest of Members has been rare in modern practice. The rules of the House provide special authority for the Speaker to recognize a Member of the Speaker’s choice to move a call of the House at any time. When a question is put to a vote by the Speaker and a quorum fails to vote on such question, if a quorum is not present and objection is made for that reason, there is a call of the House unless the House adjourns. The call is taken by electronic device, and the Sergeant-at-Arms may bring in absent Members. The yeas and nays on the pending question are at the same time considered as ordered and an ‘‘automatic’’ recorded vote is taken. The Clerk utilizes the electronic system or calls the roll, and each Member who is present may vote on the pending question. If those voting on the question and those who are present and decline to vote together constitute a majority of the House, the Speaker declares that a quorum is constituted, and the pending question is decided as the majority of those voting have determined. The rules of the House prohibit points of order of no quorum unless the Speaker has put a question to a vote. The rules for quorum calls are different in some respects in the Committee of the Whole. The first time the Committee of the Whole finds itself without a quorum during a day the Chairman is required to order the roll to be called by electronic device, unless the Chairman orders a call of the Committee. However, the Chairman may refuse to entertain a point of order of no quorum during general debate. If on a call, a quorum (100 Members) appears, the Committee continues its business. If a quorum does not appear, the Committee rises and the Chairperson reports the names of the absentees to the House. The rules provide for the expeditious conduct of quorum calls in the Committee of the Whole. The Chairperson may suspend a quorum call after 100 Members have recorded their presence. Under such a short quorum call, the Committee will not rise proceedings under the quorum call are vacated. In that case, a recorded vote, if ordered immediately following the termination of the short quorum call, is a minimum of 15 minutes. In the alternative, the Chair may choose to permit a full 15-minute quorum call, wherein all Members are recorded as present or absent, to be followed by a 5-minute record vote on the pending question. Once a quorum of the Committee of the Whole has been

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established for a day, a quorum call in the Committee is in order only when the Committee is operating under the 5-minute rule and the Chairperson has put the pending question to a vote. The rules prohibit a point of order of no quorum against a vote in which the Committee of the Whole agrees to rise. However, an appropriate point of no quorum would be permitted against a vote defeating a motion to rise.

Voting There are three methods of voting in the Committee of the Whole that are also employed in the House. These are the voice vote, the division, and the recorded vote. The yea=nay vote is an additional method used only in the House, which may be automatic if a Member objects to the vote on the ground that a quorum is not present. To conduct a voice vote the Chair puts the question: ‘‘As many as are in favor (as the question may be) say ‘Aye’. As many as are opposed, say ‘No.’’’ The Chair determines the result on a comparison of the volume of ayes and noes. This is the form in which the vote is ordinarily taken in the first instance. If it is difficult to determine the result of a voice vote, a division may be demanded by a Member or initiated by the Chair. The Chair then states: ‘‘As many as are in favor will rise and stand until counted’’ and after counting those in favor, calls on those opposed to stand and be counted, thereby determining the number in favor of and those opposed to the question. If any Member requests a recorded vote and that request is supported by at least one-fifth of a quorum of the House (44 Members), or 25 Members in the Committee of the Whole, the vote is taken by electronic device. After the recorded vote is concluded, the names of those voting and those not voting are entered in the Journal. Members have a minimum of 15 minutes to be counted from the time the record vote is ordered. The Speaker may reduce the period for voting to 5 minutes on subsequent votes in certain situations where there has been no intervening debate or business. The Speaker is not required to vote unless the Speaker’s vote would be decisive. In the House, if the yeas and nays are demanded, the Speaker directs those in favor of taking the vote by that method to stand and be counted. The support of onefifth of the Members present is necessary for ordering the yeas and nays. When the yeas and nays are ordered or a point of order is made that a quorum is not present, the Speaker states: ‘‘As many as are in favor of the proposition will vote ‘Aye.’ As many as are opposed will vote ‘No.’’’ The Clerk activates the electronic system or calls the roll and reports the result to the Speaker, who announces it to the House. The rules of the House require a three-fifths vote to pass a bill, joint resolution, amendment, or conference report that contains a specified type of federal income tax rate increase. The rules prohibit a Member from (1) casting another Member’s vote or recording another Member’s presence in the House or the Committee of the Whole or (2) authorizing another individual to cast a vote or record the Member’s presence in the House or the Committee of the Whole.

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Electronic Voting Recorded votes are usually taken by electronic device, except when the Speaker orders the vote to be recorded by other methods prescribed by the rules of the House, or in the failure of the electronic device to function. In addition, quorum calls are generally taken by electronic device. The electronic system works as follows. A number of vote stations are attached to selected chairs in the Chamber. Each station is equipped with a vote card slot and four indicators, marked ‘‘yea,’’ ‘‘nay,’’ ‘‘present,’’ and ‘‘open’’ that are lit when a vote is in progress and the system is ready to accept votes. Each Member is provided with a personalized ‘‘Vote-ID Card.’’ A Member votes by inserting the voting card into any one of the vote stations and depressing the appropriate button to indicate the Member’s choice. If a Member is without a Vote-ID Card or reconsiders and changes a vote during the last 5 minutes of the vote, the Member may be recorded by handing a paper ballot to the Tally Clerk, who then records the vote electronically according to the indicated preference of the Member. The paper ballots are green for ‘‘yea,’’ red for ‘‘nay,’’ and amber for ‘‘present.’’ The voting machine records the votes and reports the result when the vote is completed. Pairing of Members The former system of pairing of Members, where a Member could arrange in advance to be recorded as being either in favor of or opposed to the question by being ‘‘paired’’ with another absent Member who holds contrary views on the question, has been largely eliminated. The rules still allow for ‘‘live pairs,’’ where a Member votes as if not paired, subsequently withdraws that vote, and then asks to be marked ‘‘present’’ to protect the other Member. The most common practice is for absent Members to submit statements for the Record stating how they would have voted if present on specific votes. System of Lights and Bells Because of diverse nature of daily tasks that they have to perform, it is not practicable for Members to be present in the House or Senate Chamber at every minute that the body is in session. Furthermore, many of the routine matters do not require the personal attendance of all the Members. A legislative call system consisting of electric lights and bells or buzzers located in various parts of the Capitol Building and House and Senate Office Buildings alerts Members to certain occurrences in the House and Senate Chambers. In the House, the Speaker has ordered that the bells and lights comprising the system be utilized as follows:  1 long ring followed by a pause and then 3 rings and 3 lights on the left—start or continuation of a notice or short quorum call in the Committee of the Whole that will be vacated if and when 100 Members appear on the floor. Bells are

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repeated every 5 minutes unless the call is vacated or the call is converted into a regular quorum call. 1 long ring and extinguishing of 3 lights on the left—short or notice quorum call vacated. 2 rings and 2 lights on the left—15 minute recorded vote, yea=nay vote, or automatic roll call vote by electronic device. The bells are repeated five minutes after the first ring. 2 rings and 2 lights on the left followed by a pause and then 2 more rings— automatic roll call vote or yea=nay vote taken by a call of the roll in the House. The bells are repeated when the Clerk reaches the Rs in the first call of the roll. 2 rings followed by a pause and then 5 rings—first vote under Suspension of the Rules or on clustered votes. Two bells are repeated 5 minutes after the first ring. The first vote will take 15 minutes, with successive votes at intervals of not less than 5 minutes. Each successive vote is signaled by 5 rings. 3 rings and 3 lights on the left—15-minute quorum call in either the House or in the Committee of the Whole by electronic device. The bells are repeated 5 minutes after the first ring. 3 rings followed by a pause and then 3 more rings—15-minute quorum call by a call of the roll. The bells are repeated when the Clerk reaches the Rs in the first call of the roll. 3 rings followed by a pause and then 5 more rings—quorum call in the Committee of the Whole that may be followed immediately by a 5-minute recorded vote. 4 rings and 4 lights on the left—adjournment of the House. 5 rings and 5 lights on the left—any 5-minute vote. 6 rings and 6 lights on the left—recess of the House. 12 rings at 2-second intervals with 6 lights on the left—Civil Defense Warning. The 7th light indicates that the House is in session.

Recess Authority The House may by vote authorize the Speaker to declare a recess under the rules of the House. The Speaker also has the authority to declare the House in recess for a short time when no question is pending before the House.

Live Coverage of Floor Proceedings The rules of the House provide for unedited radio and television broadcasting and recording of proceedings on the floor of the House. However, the rules prohibit the use of these broadcasts and recordings for any political purpose or in any commercial advertisement. The rules of the Senate also provide for broadcasting and recording of proceedings in the Senate Chamber with similar restrictions.

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CONGRESSIONAL BUDGET PROCESS The Congressional Budget and Impoundment Control Act of 1974 as amended provides Congress with a procedure establishing appropriate spending and revenue levels for each year. The Congressional budget process, as set out in the 1974 Budget Act, is designed to coordinate decisions on sources and levels of revenues and on objects and levels of expenditures. Its basic method is to prescribe the overall size of the fiscal pie and the particular sizes of its various pieces. Each year Congress adopts a concurrent resolution imposing overall constraints on revenues and spending and distributing the overall constraint on spending among groups of programs and activities. Congress aims to complete action on a concurrent resolution on the budget for the next fiscal year by April 15. Congress may adopt a later budget resolution that revises the most recently adopted budget resolution. One of the mechanisms Congress uses to implement the constraints on revenue and spending is called the reconciliation process, a two-step process designed to bring existing law in conformity with the most recently adopted concurrent resolution on the budget. The first step in the reconciliation process is the language found in a concurrent resolution on the budget instructing House and Senate committees to determine and recommend changes in laws or bills that will achieve the constraints established in the concurrent resolution on the budget. The instructions to a committee specify the amount of spending reductions or revenue changes a committee must attain and leave to the discretion of the committee the specific changes to laws or bills that must be made. The second step involves the combination of the various instructed committees’ recommendations into an omnibus reconciliation bill that is reported by the Committee on the Budget or by the one committee instructed, if only one committee has been instructed, and considered by the whole House. The Budget Act maintains that reconciliation provisions must be related to reconciling the budget. This principle is codified in Section 313 of the Budget Act, the socalled Byrd rule, named after Senator Robert C. Byrd of West Virginia. Section 313 provides a point of order in the Senate against extraneous matter in reconciliation bills. Determining what is extraneous is a difficult task for the Senate’s Presiding Officer. The Byrd rule may only be waived in the Senate by a three-fifths vote and sixty votes are required to overturn the presiding officer’s ruling. Congress aims to complete action on a reconciliation bill or resolution by June 15 of each year. After Congress has completed action on a concurrent resolution on the budget for a fiscal year, it is seldom in order to consider legislation that does not conform to the constraints on spending and revenue set out in the resolution. Congress has enacted legislation under which breaches are remedied by ‘‘sequestration,’’ that is, automatic cancellations of spending authority. Sequestration results when the statutory parameters for the deficit, discretionary spending, or the ‘‘Paygo’’ requirement have been exceeded. Paygo requires that tax reductions or increases in entitlements must be offset by tax increases or reductions in entitlements. The Unfunded Mandates Reform Act of 1995, through an amendment to the Congressional Budget Act, established requirements on committees with respect

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to measures containing unfunded intergovernmental mandates. An unfunded intergovernmental mandate is the imposition of a substantial financial requirement or obligation on a state, local, or tribal government. The Act also established a unique point of order to enforce the requirements of the Act with respect to intergovernmental mandates in excess of $50 million annually. In the House, an unfunded mandate point of order is not disposed of by a ruling of the Chair but by the Chair putting the question of consideration to the body. The House or the Committee of the Whole then decides by vote whether to proceed with the measure with the alleged mandate contained therein.

ENGROSSMENT AND MESSAGE TO SENATE Preparation of a copy of the bill in the form in which it has passed the House can be a detailed and complicated process because of the large number and complexity of amendments to some bills adopted by the House. Frequently, these amendments are offered during a spirited debate with little or no prior formal preparation. The amendment may be for the purpose of inserting new language, substituting different words for those set out in the bill, or deleting portions of the bill. It is not unusual to have more than 100 amendments adopted, including those proposed by the committee at the time the bill is reported and those offered from the floor during the consideration of the bill in the Chamber. In some cases, amendments offered from the floor are written in longhand. Each amendment must be inserted in precisely the proper place in the bill, with the spelling and punctuation exactly as it was adopted by the House. It is extremely important that the Senate receive a copy of the bill in the precise form in which it has passed the House. The preparation of such a copy is the function of the enrolling clerk. In the House, the enrolling clerk is under the Clerk of the House. In the Senate, the enrolling clerk is under the Secretary of the Senate. The enrolling clerk receives all the papers relating to the bill, including the official Clerk’s copy of the bill as reported by the standing committee and each amendment adopted by the House. From this material, the enrolling clerk prepares the engrossed copy of the bill as passed, containing all the amendments agreed to by the House. At this point, the measure ceases technically to be called a bill and is termed ‘‘an Act,’’ signifying that it is the act of one body of the Congress, although it is still popularly referred to as a bill. The engrossed bill is printed on blue paper and is signed by the Clerk of the House. Bills may also originate in the Senate with certain exceptions.

SENATE ACTION The Parliamentarian, in the name of the Vice President, as the President of the Senate, refers the engrossed bill to the appropriate standing committee of the Senate in conformity with the rules of the Senate. The bill is reprinted immediately

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and copies are made available in the document rooms of both Houses. This printing is known as the ‘‘Act print’’ or the ‘‘Senate referred print.’’

Committee Consideration Senate committees give the bill the same detailed consideration as it received in the House and may report it with or without amendment. A committee member who wishes to express an individual view or a group of Members who wish to file a minority report may do so by giving notice, at the time of the approval of a report on the measure, of an intention to file supplemental, minority, or additional views. These views may be filed within 3 days with the clerk of the committee and become a part of the report. When a committee reports a bill, it is reprinted with the committee amendments indicated by showing new matter in italics and deleted matter in line-through type. The calendar number and report number are indicated on the first and back pages, together with the name of the Senator making the report. The committee report and any minority or individual views accompanying the bill also are printed at the same time. All committee meetings, including those to conduct hearings, must be open to the public. However, a majority of the members of a committee or subcommittee may, after discussion in closed session, vote in open session to close a meeting or series of meetings on the same subject for no longer than 14 days if it is determined that the matters to be discussed or testimony to be taken will (1) disclose matters necessary to be kept secret in the interests of national defense or the confidential conduct of the foreign relations of the United States; (2) relate solely to internal committee staff management or procedure; (3) tend to charge an individual with a crime or misconduct, to disgrace or injure the professional standing of an individual, or otherwise to expose an individual to public contempt; (4) represent a clearly unwarranted invasion of the privacy of an individual; (5) disclose law enforcement information that is required to be kept secret; (6) disclose certain information regarding certain trade secrets; or (7) may disclose matters required to be kept confidential under other provisions of law or government regulation.

Chamber Procedure The rules of procedure in the Senate differ to a large extent from those in the House. The Senate relies heavily on the practice of obtaining unanimous consent for actions to be taken. For example, at the time that a bill is reported, the Majority Leader may ask unanimous consent for the immediate consideration of the bill. If the bill is of a noncontroversial nature and there is no objection, the Senate may pass the bill with little or no debate and with only a brief explanation of its purpose and effect. Even in this instance, the bill is subject to amendment by any Senator. A simple majority vote is necessary to carry an amendment as well as to pass the bill. If there is any objection, the report must lie over one legislative day and the bill is placed on the calendar.

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Measures reported by standing committees of the Senate may not be considered unless the report of that committee has been available to Senate Members for at least 2 days (excluding Sundays and legal holidays) prior to consideration of the measure in the Senate. This requirement, however, may be waived by agreement of the Majority and Minority leaders and does not apply in certain emergency situations. In the Senate, measures are brought up for consideration by a simple unanimous consent request, a complex unanimous consent agreement, or a motion to proceed to the consideration of a measure on the calendar. A unanimous consent agreement, sometimes referred to as a ‘‘time agreement,’’ makes the consideration of a measure in order and often limits the amount of debate that will take place on the measure and lists the amendments that will be considered. The offering of a unanimous consent request to consider a measure or the offering of a motion to proceed to the consideration of a measure is reserved, by tradition, to the Majority Leader. Usually a motion to consider a measure on the calendar is made only when unanimous consent to consider the measure cannot be obtained. There are two calendars in the Senate, the Calendar of Business and the Executive Calendar. All legislation is placed on the Calendar of Business and treaties, and nominations are placed on the Executive Calendar. Unlike the House, there is no differentiation on the Calendar of Business between the treatment of (1) bills raising revenue, general appropriation bills and bills of a public character appropriating money or property and (2) other bills of a public character not appropriating money or property. The rules of the Senate provide that at the conclusion of the morning business for each ‘‘legislative day’’ the Senate proceeds to the consideration of the calendar. In the Senate, the term ‘‘legislative day’’ means the time from when the Senate adjourns to the next time it adjourns. Because the Senate often ‘‘recesses’’ rather than ‘‘adjourns’’ at the end of a daily session, the legislative day usually does not correspond to the 24-hour period constituting a calendar day. Thus, a legislative day may cover a long period of time—from days to weeks, or even months. Because of this and the modern practice of waiving the call of the calendar by unanimous consent at the start of a new legislative day, it is rare to have a call of the calendar. When the calendar is called, bills that are not objected to are taken up in their order, and each Senator is entitled to speak once and for only 5 minutes on any question. Objection may be interposed at any stage of the proceedings, but on motion the Senate may continue consideration after the call of the calendar is completed, and the limitations on debate then do not apply. On any day (other than a Monday that begins a new legislative day), following the announcement of the close of morning business, any Senator, usually the Majority Leader, obtaining recognition may move to take up any bill out of its regular order on the calendar. The 5-minute limitation on debate does not apply to the consideration of a bill taken up in this manner, and debate may continue until the hour when the Presiding Officer of the Senate ‘‘lays down’’ the unfinished business of the day. At that point consideration of the bill is discontinued and the measure reverts back to the Calendar of Business and may again be called up at another time under the same conditions.

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When a bill has been objected to and passed over on the call of the calendar, it is not necessarily lost. The Majority Leader, after consulting the Minority Leader, determines the time at which the bill will be considered. At that time, a motion is made to consider the bill. The motion is debatable if made after the morning hour. Once a Senator is recognized by the Presiding Officer, the Senator may speak for as long as desired and loses the floor only when yielding it or taking certain parliamentary actions that forfeit that Senator’s right to the floor. However, a Senator may not speak more than twice on any one question in debate on the same legislative day without leave of the Senate. Debate ends when a Senator yields the floor and no other Senator seeks recognition, or when a unanimous consent agreement limiting the time of debate is operating. On occasion, Senators opposed to a measure may extend debate by making lengthy speeches or a number of speeches at various stages of consideration intended to prevent or defeat action on the measure. This is the tactic known as ‘‘filibustering.’’ Debate, however, may be closed if 16 Senators sign a motion to that effect and the motion is carried by three-fifths of the Senators duly chosen and sworn. Such a motion is voted on one hour after the Senate convenes, following a quorum call on the next day after a day of session has intervened. This procedure is called ‘‘invoking cloture.’’ In 1986, the Senate amended its rules to limit ‘‘postcloture’’ consideration to 30 hours. A Senator may speak for not more than one hour and may yield all or a part of that time to the majority or minority floor managers of the bill under consideration or to the Majority or Minority leader. The Senate may increase the time for ‘‘postcloture’’ debate by a vote of three-fifths of the Senators duly chosen and sworn. After the time for debate has expired, the Senate may consider only amendments actually pending before voting on the bill. While a measure is being considered it is subject to amendment, and each amendment, including those proposed by the committee that reported the bill, is considered separately. Generally, there is no requirement that proposed amendments be germane to the subject matter of the bill except in the case of general appropriation bills or where ‘‘cloture’’ has been invoked. Under the rules, a ‘‘rider,’’ an amendment proposing substantive legislation to an appropriation bill, is prohibited. However, this prohibition may be suspended by two-thirds vote on a motion to permit consideration of such an amendment on one day’s notice in writing. Debate must be germane during the first 3 hours after business is laid down unless determined to the contrary by unanimous consent or on motion without debate. After final action on the amendments the bill is ready for engrossment and the third reading, which is by title only. The Presiding Officer then puts the question on the passage, and a voice vote is usually taken, although a yea=nay vote is in order if demanded by one-fifth of the Senators present. A simple majority is necessary for passage. Before an amended measure is cleared for its return to the House of Representatives, or an unamended measure is cleared for enrollment, a Senator who voted with the prevailing side, or who abstained from voting, may make a motion within the next 2 days to reconsider the action. If the measure was passed without a recorded vote, any Senator may make the motion to reconsider. That motion is usually tabled and its tabling

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constitutes a final determination. If, however, the motion is granted, the Senate, by majority vote, may either affirm its action, which then becomes final, or reverse it. The original engrossed House bill, together with the engrossed Senate amendments, if any, is then returned to the House with a message stating the action taken by the Senate. Where the Senate has adopted amendments, the message requests that the House concur in them. For a more detailed discussion of Senate procedure, see Appendix F (below).

FINAL ACTION ON AMENDED BILL On their return to the House, the official papers relating to the amended measure are placed on the Speaker’s table to await House action on the Senate amendments. Although this authority is rarely exercised, the Speaker has the authority to refer Senate amendments to the appropriate committee(s) with or without time limits on their consideration. If the amendments are of a minor or noncontroversial nature, any Members, usually the chairman of the committee that reported the bill, may, at the direction of the committee, ask unanimous consent to take the bill with the amendments from the Speaker’s table and agree to the Senate amendments. At this point, the Clerk reads the title of the bill and the Senate amendments. If there is no objection, the amendments are then declared to be agreed to, and the bill is ready to be enrolled for presentation to the President. If unanimous consent is not obtainable, the few bills that do not require consideration in the Committee of the Whole are privileged and may be called up from the Speaker’s table by motion for immediate consideration of the amendments. A simple majority is necessary to carry the motion and thereby complete floor action on the measure. A Senate amendment to a House bill is subject to a point of order that it must first be considered in the Committee of the Whole, if, originating in the House, it would be subject to that point of order. Most Senate amendments require consideration in the Committee of the Whole, and this procedure by privileged motion is seldom utilized.

Request for a Conference The mere fact that each House may have separately passed its own bill on a subject is not sufficient to make either bill eligible for conference. One House must first take the additional step of amending and then passing the bill of the other House to form the basis for a conference. If the amendments are substantial or controversial, a Member, usually the chairperson of the committee of jurisdiction, may request unanimous consent to take the House bill with the Senate amendments from the Speaker’s table, disagree to the amendments and request or agree to a conference with the Senate to resolve the disagreeing votes of the two Houses. In the case of a Senate bill with House amendments, the House may insist on the House amendments and request a conference. If there is objection, the Speaker may recognize a

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Member for a motion, if offered by the direction of the primary committee and of all reporting committees that had initial referral of the bill, to (1) disagree to the Senate amendments and ask for or agree to a conference or (2) insist on the House amendments to a Senate bill and request or agree to a conference. This may also be accomplished by a motion to suspend the rules with a two-thirds vote or by a rule from the Committee on Rules. If there is no objection to the request, or if the motion is carried, a motion to instruct the managers of the conference would be in order. This initial motion to instruct is the prerogative of the minority party. The instructions to conferees usually urge the managers to accept or reject a particular Senate or House provision or to take a more generally described political position to the extent possible within the scope of the conference. However, such instructions are not binding on House or Senate conferees. After the motion to instruct is disposed of, the Speaker then appoints the managers, informally known as ‘‘conferees,’’ on the part of the House, and a message is sent to the Senate advising it of the House action. A majority of the Members appointed to be conferees must have been supporters of the House position, as determined by the Speaker. The Speaker must appoint Members primarily responsible for the legislation and must include, to the fullest extent feasible, the principal proponents of the major provisions of the bill as it passed the House. The Speaker usually follows the suggestion of the committee chairman bill designating the conferees on the part of the House from among the members of the committee with jurisdiction over the House or Senate provisions. Occasionally, the Speaker appoints conferees from more than one committee and may specify the portions of the House and Senate versions to which they are assigned. The number is fixed by the Speaker, and majority party representation generally reflects the ratio for the full House committee, but may be greater on important bills. The Speaker also has the authority to name substitute conferees on specific provisions and add or remove conferees after the Speaker’s original appointment. Representation of both major parties is an important attribute of all our parliamentary procedures but, in the case of conference committees, it is important that the views of the House on the House measure be fully represented. If the Senate agrees to the request for a conference, a similar committee is appointed by unanimous consent by the Presiding Officer of the Senate. Both political parties may be represented on the Senate conference committee. The Senate and House committees need not be the same size but each House has one vote in conference as determined by a majority within each set or subset of managers. The request for a conference can be made only by the body in possession of the official papers. Occasionally, the Senate, anticipating that the House will not concur in its amendments, votes to insist on its amendments and requests a conference on passage of the bill prior to returning the bill to the House. This practice serves to expedite the matter because time may be saved by the designation of the Senate conferees before returning the bill to the House. The matter of which body requests the conference is not without significance because the body asking for the conference normally acts last on the report to be submitted by the conferees and a motion to recommit the conference report is not available to the body that acts last.

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Authority of Conferees The conference committee is sometimes popularly referred to as the ‘‘Third House of Congress.’’ Although the managers on the part of each House meet together as one committee they are in effect two separate committees, each of which votes separately and acts by a majority vote. For this reason, the number of managers from each House is largely immaterial. The conferees are strictly limited in their consideration to matters in disagreement between the two Houses. Consequently, they may not strike out or amend any portion of the bill that was not amended by the other House. Furthermore, they may not insert new matter that is not germane to or that is beyond the scope of the differences between the two Houses. Where the Senate amendment revises a figure or an amount contained in the bill, the conferees are limited to the difference between the two numbers and may neither increase the greater nor decrease the smaller figure. Neither House may alone, by instructions, empower its managers to introduce a change in the text to which both Houses have agreed. When a disagreement to an amendment in the nature of a substitute is committed to a conference committee, managers on the part of the House may propose a substitute that is a germane modification of the matter in disagreement, but the introduction of any language in that substitute presenting specific additional matter not committed to the conference committee by either House is not in order. Moreover, their report may not include matter not committed to the conference committee by either House. The report may not include a modification of any specific matter committed to the conference committee by either or both Houses if that modification is beyond the scope of that specific topic, question, issue, or proposition as committed to the conference committee. The managers on the part of the House are under specific guidelines when in conference on general appropriation bills. An amendment by the Senate to a general appropriation bill that would be in violation of the rules of the House, if such amendment had originated in the House, including an amendment changing existing law, providing appropriations not authorized by law, or providing reappropriations of unexpired balances, or an amendment by the Senate providing for an appropriation on a bill other than a general appropriation bill, may not be agreed to by the managers on the part of the House. However, the House may grant specific authority to agree to such an amendment by a separate vote on each specific amendment.

Meetings and Action of Conferees The rules of the House require that one conference meeting be open, unless the House, in open session, determines by a record vote that a meeting will be closed to the public. When the report of the conference committee is read in the House, a point of order may be made that the conferees failed to comply with the House rule requiring an open conference meeting. If the point of order is sustained, the conference report is considered rejected by the House and a new conference is deemed to have been requested.

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There are generally four forms of recommendations available to the conferees when reporting back to their bodies: 1. The Senate recede from all (or certain of) its amendments. 2. The House recede from its disagreement to all (or certain of) the Senate amendments and agree thereto. 3. The House recede from its disagreement to all (or certain of) the Senate amendments and agree thereto with amendments. 4. The House recede from all (or certain of) its amendments to the Senate amendments or its amendments to Senate bill. In most instances, the result of the conference is a compromise growing out of the third type of recommendation available to the conferees because one House has originally substituted its own bill to be considered as a single amendment. The complete report may be composed of any one or more of these recommendations with respect to the various amendments where there are number amendments. Occasionally, on general appropriation bills with numbered Senate amendments, because of the special rules preventing House conferees from agreeing to Senate amendments changing existing law or appropriations not authorized by law, the conferees find themselves, under the rules or in fact, unable to reach an agreement with respect to one or more amendments and report back a statement of their inability to agree on those particular amendments. These amendments may then be acted on separately. This partial disagreement is not practicable where, as is most often the case, one House strikes out all after the enacting clause and substitutes its own bill that must be considered as a single amendment. If they are unable to reach any agreement whatsoever, the conferees report that fact to their respective bodies and the amendments may be disposed of by motion. Usually, new conferees may be appointed in either or both Houses. In addition, the Houses may provide a new nonbinding instruction to the conferees as to the position they are to take. After House conferees on any bill or resolution in conference between the two bodies have been appointed for 20 calendar days and have failed to make a report, a motion to instruct the House conferees, or discharge them and appoint new conferees, is privileged. The motion can be made only after the Member announces an intention to offer the motion and only at a time designated by the Speaker in the legislative schedule of the following day. In addition, during the last 6 days of a session, it is a privileged motion to move to discharge, appoint, or instruct House conferees after House conferees have been appointed 36 hours without having made a report.

Conference Reports When the conferees, by majority vote of each group, have reached complete agreement or find that they are able to agree with respect to some but not all separately

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numbered amendments, they make their recommendations in a report made in duplicate that must be signed by a majority of the conferees appointed by each body on each provision to which they are appointed. The minority of the managers have no authority to file a statement of minority views in connection with the conference report. The report must be printed in both Houses and accompanied by an explanatory statement prepared jointly by the conferees on the part of the House and the conferees on the part of the Senate. The statement must be sufficiently detailed and explicit to inform Congress of the effect of the report on the matters committed to conference. The engrossed bill and amendments and one copy of the report are delivered to the body that is to act first on the report, usually the body that had agreed to the conference requested by the other. In the Senate, the presentation of a conference report always is in order except when the Journal is being read, a point of order or motion to adjourn is pending, or the Senate is voting or ascertaining the presence of a quorum. When the report is received, the question of proceeding to the consideration of the report, if raised, is immediately voted on without debate. The report is not subject to amendment in either body and must be accepted or rejected as an entirety. If the time for debate on the adoption of the report is limited, the time allotted must be equally divided between the majority and minority parties. The Senate, acting first, prior to voting on agreeing to the report, may by majority vote order it recommitted to the conferees. When the Senate agrees to the report, its managers are thereby discharged and it delivers the original papers to the House with a message advising that body of its action. A report that contains any recommendations that extend beyond the scope of differences between the two Houses is subject to a point of order in its entirety unless that point of order is waived in the House by unanimous consent, adoption of a rule reported from the Committee on Rules, or the suspension of the rules by a two-thirds vote. The presentation of a conference report in the House is in order at any time, except during a reading of the Journal or the conduct of a recorded vote, a vote by division, or a quorum call. The report is considered in the House and may not be sent to the Committee of the Whole on the suggestion that it contains matters ordinarily requiring consideration in that Committee. The report may not be received by the House if the required statement does not accompany it. However, it is not in order to consider either (1) a conference report or (2) a motion to dispose of a Senate amendment (including an amendment in the nature of a substitute) by a conference committee, until the third calendar day (excluding Saturdays, Sundays, and legal holidays unless the House is in session on those days) after the report and accompanying statement have been filed in the House and made available to Members in the Congressional Record. However, these provisions do not apply during the last 6 days of the session. It is also not in order to consider a conference report or a motion to dispose of a Senate amendment reported in disagreement unless copies of the report and accompanying statement, together with the text of the amendment, have been available to Members for at least two hours before their consideration. By contrast, it is always in order to call up for

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consideration a report from the Committee on Rules on the same day reported that proposes only to waive the availability requirements for a conference report or a Senate amendment reported in disagreement. The time allotted for debate on a conference report or motion is one hour, equally divided between the majority party and the minority party. However, if the majority and minority floor managers both support the conference report or motion, one-third of the debate time must be allotted to a Member who is opposed. If the House does not agree to a conference report that the Senate has already agreed to, the report may not be recommitted to conference. In that situation, the Senate conferees are discharged when the Senate agrees to the report. The House may then request a new conference with the Senate and conferees must be reappointed. If a conference report is called up before the House containing matter that would be in violation of the rules of the House with respect to germaneness if the matter had been offered as an amendment in the House, and that is contained either (1) in the Senate bill or Senate amendment to the House measure (including a Senate amendment in the nature of a substitute for the text of that measure as passed by the House) and accepted by the House conferees or agreed to by the conference committee with modification or (2) in a substitute amendment agreed to by the conference committee, a point of order may be made at the beginning of consideration that nongermane matter is contained in the report. The point of order may also be waived by special rule. If the point of order is sustained, a motion to reject the nongermane matter identified by the point of order is privileged. The motion is debatable for 40 minutes, one-half of the time in favor of, and one-half in opposition to, the motion. Notwithstanding the final disposition of a point of order made with respect to the report, or of a motion to reject nongermane matter, further points of order may be made with respect to the report, and further motions may be made to reject other nongermane matter in the conference report not covered by any previous point of order that has been sustained. If a motion to reject has been adopted, after final disposition of all points of order and motions to reject, the conference report is considered rejected and the question then pending before the House is whether to (1) recede and concur with an amendment that consists of that portion of the conference report not rejected or (2) insist on the House amendment. If all motions to reject are defeated and the House thereby decides to permit the inclusion of the nongermane Senate matter in the conference report, then, after the allocation of time for debate on the conference report, it is in order to move the previous question on the adoption of the conference report. Similar procedures are available in the House when the Senate proposes an amendment to a measure that would be in violation of the rule against nongermane amendments, and thereafter it is (1) reported in disagreement by a committee of conference or (2) before the House and the stage of disagreement is reached. The numbered amendments of the Senate reported in disagreement may be voted on separately and may be adopted by a majority vote after the adoption of the conference report itself as though there had been no conference regarding those amendments. The Senate may recede from all amendments, or from certain of its amendments, insisting on the others with or without a request for a further

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conference with respect to them. If the House does not accept the amendments insisted on by the Senate, the entire conference process may begin anew to consider these amendments. One House may also further amend an amendment of the other House until the third degree stage of amendment within that House is reached.

Custody of Papers The custody of the original official papers is important in conference procedure because either body may act on a conference report only when in possession of the papers. The papers are transmitted to the body agreeing to the conference and from that body to the managers of the House that asked for the conference. The latter in turn carry the papers with them to the conference and at its conclusion turn them over to the managers of the House that agreed to the conference. The managers of the House that agreed to the conference deliver them to their own House, that acts first on the report, and then delivers the papers to the other House for final action on the report. However, if the managers on the part of the House agreeing to the conference surrender the papers to the House asking for the conference, the report may be acted on first by the House asking for the conference. At the conclusion of the conference, each group of conferees retains one copy of the report that has been made in duplicate and signed by a majority of the managers of each body. The House copy is signed first by the House managers and the Senate copy is signed first by its managers. A bill cannot become a law of the land until it has been approved in identical form by both Houses of Congress. When the bill has finally been approved by both Houses, all the original papers are transmitted to the enrolling clerk of the body in which the bill originated.

BILL ORIGINATING IN SENATE The preceding discussion described the legislative process for bills originating in the House. When a bill originates in the Senate, this process is reversed. When the Senate passes a bill that originated in the Senate, it is sent to the House for consideration unless it is held by unanimous consent to become a vehicle for a similar House bill, if and when passed by the House. The Senate bill is referred to the appropriate House committee for consideration or held at the Speaker’s table for possible amendment following action on a companion House bill. If the committee reports the bill to the full House and if the bill is passed by the House without amendment, it is ready for enrollment. If the House passes an amended version of the Senate bill, the bill is returned to the Senate for action on the House amendments. The Senate may agree to the amendments or request a conference to resolve the disagreement over the House amendments or may further amend the House amendments. In accordance with the Constitution, the Senate cannot originate revenue measures. By tradition, the House also originates general appropriations bills. If the Senate does originate a revenue measure, either as a Senate bill or an

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amendment to a nonrevenue House bill, it can be returned to the Senate by a vote of the House as an infringement of the constitutional prerogative of the House. ENROLLMENT When the bill has been agreed to in identical form by both bodies—either (1) without amendment by the Senate, (2) by House concurrence in the Senate amendments, (3) by Senate concurrence in House amendments, or (4) by agreement in both bodies to the conference report—a copy of the bill is enrolled for presentation to the President. The preparation of the enrolled bill is a painstaking and important task because it must reflect precisely the effect of all amendments, either by way of deletion, substitution, or addition, agreed to by both bodies. The enrolling clerk of the House, with respect to bills originating in the House, receives the original engrossed bill, the engrossed Senate amendments, the signed conference report, several messages from the Senate, and a notation of the final action by the House, for the purpose of preparing the enrolled copy. From these documents the enrolling clerk must meticulously prepare for presentation to the President the final form of the bill as it was agreed to by both Houses. On occasion, as many as 500 amendments have been adopted, each of which must be set out in the enrollment exactly as agreed to, and all punctuation must be in accord with the action taken. The enrolled bill is printed on parchment paper and certified by the Clerk of the House stating that the bill originated in the House of Representatives. A bill originating in the Senate is examined and certified by the Secretary of the Senate. A House bill is then examined for accuracy by the Committee on House Administration. When the committee is satisfied with the accuracy of the bill, the committee chairperson attaches a slip stating that it finds the bill truly enrolled and sends it to the Speaker of the House for signature. All bills, regardless of the body in which they originated, are signed first by the Speaker and then by the Vice President of the United States, who, under the Constitution, serves as the President of the Senate. The President pro tempore of the Senate may also sign enrolled bills. The Speaker of the House may sign enrolled bills regardless of whether the House is in session. The President of the Senate may sign bills only while the Senate is actually sitting, but advance permission is normally granted to sign during a recess or after adjournment. If the Speaker or the President of the Senate is unable to sign the bill, it may be signed by an authorized Member of the respective House. After both signatures are affixed, a House bill is returned to the Committee on House Administration for presentation to the President for action under the Constitution. A Senate bill is presented to the President by the Secretary of the Senate. PRESIDENTIAL ACTION Article I, Section 7, of the Constitution provides in part that ‘‘Every Bill which shall have passed the House of Representatives and the Senate, shall, before it becomes a Law, be presented to the President of the United States.’’

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In actual practice, a clerk of the Committee on House Administration, or the Secretary of the Senate when the bill originated in that body, delivers the original enrolled bill to a clerk at the White House and obtains a receipt. The fact of the delivery is then reported to the House by the committee chairperson. Delivery to a White House clerk has customarily been regarded as presentation to the President and as commencing the 10-day constitutional period for presidential action. Copies of the enrolled bill usually are transmitted by the White House to the various departments interested in the subject matter so that they may advise the President on the issues surrounding the bill. If the President approves the bill, he signs it and usually writes the word ‘‘approved’’ and the date. However, the Constitution requires only that the President sign it. The bill may become law without the President’s signature by virtue of the constitutional provision that if the President does not return a bill with objections within 10 days (excluding Sundays) after it has been presented to the President, the bill becomes law as if the President had signed it. However, if Congress by their adjournment prevent its return, it does not become law. This is known as a ‘‘pocket veto’’; that is, the bill does not become law even though the President has not sent his objections to Congress. Congress has interpreted the President’s ability to pocket veto a bill to be limited to final adjournment ‘‘sine die’’ of a Congress where Congress has finally prevented return by the originating House and not to interim adjournments or first session adjournments where the originating House of Congress through its agents is able to receive a veto message for subsequent reconsideration by that Congress when it reconvenes. The extent of pocket veto authority has not been definitively decided by the courts. Notice of the signing of a bill by the President is sent by message to the House in which it originated and that House informs the other, although this action is not necessary for the act to be valid. The action is also noted in the Congressional Record. A bill becomes law on the date of approval or passage over the President’s veto, unless it expressly provides a different effective date. Veto Message According to the terms of the Constitution, if the President does not approve the bill ‘‘he shall return it, with his Objections to that House in which it shall have originated, who shall enter the Objections at large on their Journal, and proceed to reconsider it.’’ A bill returned with the President’s objections need not be voted on at once when laid before the House since the vetoed bill can be postponed, referred back to committee, or tabled before the question on passage is pending. A vetoed bill is always privileged until directly voted on, and a motion to take it from the table or from committee is in order at any time. Once the relevant Member moves the previous question on the question of override, the question is then put by the Speaker as follows: ‘‘Will the House on reconsideration agree to pass the bill, the objections of the President to the contrary notwithstanding?’’ Under the Constitution, a vote by the yeas and nays is required

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to pass a bill over the President’s veto. The Clerk activates the electronic system or calls the roll with those in favor of passing the bill answering ‘‘Aye,’’ and those opposed, ‘‘No.’’ If fewer than two-thirds of the Members present vote in the affirmative, with a quorum present, the bill is rejected, and a message is sent to the Senate advising that body of the House action. However, if two-thirds vote in the affirmative, the bill is sent with the President’s objections to the Senate, unless that body has acted first, together with a message advising it of the action in the House. The procedure in the Senate is the same, as a two-thirds affirmative vote is also necessary to pass the bill over the President’s objections. If the Senate joins the House and votes two-thirds in the affirmative to pass the bill, the measure becomes the law of the land notwithstanding the objections of the President, and it is ready for publication as a binding statute. Line Item Veto From 1997 until it was declared unconstitutional in 1998, the Line Item Veto Act provided the President authority to cancel certain individual items contained in a bill or joint resolution that he had signed into law. The law allowed the President to cancel only three types of fiscal items: a dollar amount of discretionary budget authority, an item of new direct spending, and a tax change benefiting a class of 100 or fewer. The cancellations had to be received by the House and Senate within 5 calendar days of the enactment of such a law and were effective unless disapproved. The President had to submit a single message to both Houses containing all the cancellations per law. The Act also provided special expedited procedures by which the House and Senate could consider a bill or joint resolution disapproving a President’s cancellation. Such a ‘‘disapproval bill’’ was subject to a majority vote in the House and Senate and was presented to the President for signature or veto under the Constitution. If the disapproval bill were vetoed by the President, the House and Senate could override the veto by a two-thirds vote in each House, in which case the President’s cancellations would be null and void. While the Act has not been repealed, the U.S. Supreme Court in Clinton v. City of New York, 118 S. Ct. 2091, (1998) struck down the Line Item Veto Act as unconstitutional.

PUBLICATION One important step in the enactment of a valid law is the requirement that it shall be made known to the people who are to be bound by it. There would be no justice if the state were to hold its people responsible for their conduct before it made known to them the unlawfulness of such behavior. In practice, our laws are published immediately upon their enactment so that the public will be aware of them. If the President approves a bill, or allows it to become law without signing it, the original enrolled bill is sent from the White House to the Archivist of the United States for publication. If a bill is passed by both Houses over the objections of the President, the body that last overrides the veto transmits it. It is then assigned a

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public law number, and paginated for the Statutes at Large volume covering that session of Congress. The public and private law numbers run in sequence starting anew at the beginning of each Congress and are prefixed for ready identification by the number of Congress. For example, the first public law of the 106th Congress is designated Public Law 106-1 and the first private law of the 106th Congress is designated Private Law 106-1. Subsequent laws of this Congress also will contain the same prefix designator.

Slip Laws The first official publication of the statute is in the form generally known as the ‘‘slip law.’’ In this form, each law is published separately as an unbound pamphlet. The heading indicates the public or private law number, the date of approval, and the bill number. The heading of a slip law for a public law also indicates the United States Statutes at Large citation. If the statute has been passed over the veto of the President, or has become law without the President’s signature because he did not return it with objections, an appropriate statement is inserted instead of the usual notation of approval. The Office of the Federal Register, National Archives and Records Administration, prepares the slip laws and provides marginal editorial notes giving the citations to laws mentioned in the text and other explanatory details. The marginal notes also give the United States Code classifications, enabling the reader immediately to determine where the statute will appear in the Code. Each slip law also includes an informative guide to the legislative history of the law consisting of the committee report number and the name of the committee in each House, as well as the date of consideration and passage in each House, with a reference to the Congressional Record by volume, year, and date. A reference to presidential statements relating to the approval of a bill or the veto of a bill when the veto was overridden and the bill becomes law is included in the legislative history as a citation to the Weekly Compilation of Presidential Documents. Copies of the slip laws are delivered to the document rooms of both Houses, where they are available to officials and the public. They may also be obtained by annual subscription or individual purchase from the Government Printing Office and are available in electronic form for computer access. Section 113 of Title 1 of the United States Code provides that slip laws are competent evidence in all the federal and state courts, tribunals, and public offices.

Statutes at Large The United States Statutes at Large, prepared by the Office of the Federal Register, National Archives and Records Administration, provide a permanent collection of the laws of each session of Congress in bound volumes. The latest volume containing the laws of the first session of the 105th Congress is number 111 in the series. Each volume contains a complete index and a table of contents. A legislative history

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appears at the end of each law. There are also extensive marginal notes referring to laws in earlier volumes and to earlier and later matters in the same volume. Under the provisions of a statute originally enacted in 1895, these volumes are legal evidence of the laws contained in them and will be accepted as proof of those laws in any court in the United States. The Statutes at Large are a chronological arrangement of the laws exactly as they have been enacted. The laws are not arranged according to subject matter and do not reflect the present status of an earlier law that has been amended. The laws are organized in that manner in the code of laws.

United States Code The United States Code contains a consolidation and codification of the general and permanent laws of the United States arranged according to subject matter under 50 title headings, in alphabetical order to a large degree. It sets out the current status of the laws, as amended, without repeating all the language of the amendatory acts except where necessary. The Code is declared to be prima facie evidence of those laws. Its purpose is to present the laws in a concise and usable form without requiring recourse to the many volumes of the Statutes at Large containing the individual amendments. The Code is prepared by the Law Revision Counsel of the House of Representatives. New editions are published every 6 years, and cumulative supplements are published after conclusion of each regular session of the Congress. The Code is also available in electronic form. Twenty-three of the 50 titles have been revised and enacted into positive law, and two have been eliminated by consolidation with other titles. Titles that have been revised and enacted into positive law are legal evidence of the law and the courts will receive them as proof of those laws. Eventually all the titles will be revised and enacted into positive law. At that point, they will be updated by direct amendment.

APPENDIX: SELECT LIST OF GOVERNMENT PUBLICATIONS The following items are the major publications and documents of the Federal government: Constitution of the United States of America. Analysis and Interpretation, with annotations of cases decided by the Supreme Court of the United States to June 29, 1992; prepared by Congressional Research Service, Library of Congress, Johnny H. Killian, George A. Costello, co-editors, Senate Document 103-6 (1996). House Rules and Manual. Constitution, Jefferson’s Manual, and Rules of the House of Representatives of the United States, prepared by Charles W.

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Johnson, Parliamentarian of the House, House Document 105-538 (1999). New editions are published each Congress. Senate Manual. Contains the rules, orders, laws, and resolutions affecting the business of the United States Senate; Jefferson’s Manual, Declaration of Independence, Articles of Confederation, Constitution of the United States, and similar, prepared under the direction of Senate Committee on Rules and Administration. New editions are published each Congress. Hinds’ and Cannon’s Precedents of the House of Representatives. Includes references to provisions of the Constitution, laws, and decisions of the Senate, by Asher C. Hinds, Vols. 1–5 (1907); Vols. 6–8 (1935), as compiled by Clarence Cannon, are supplementary to Vols. 1–5 and cover the 28-year period from 1907 to 1935, revised up to and including the 73d Congress. Volumes 9–11 (1941) are index digest to Vols. 1–8. Deschler–Brown Precedents of the United States House of Representatives. Includes references to provisions of the Constitution and laws, and to decisions of the courts, covering the period from 1928 to date, by Lewis Deschler, J.D., D.J., M.P.L., LL.D., Parliamentarian of the House (1928–1974), Wm. Holmes Brown, Parliamentarian of the House (1974–1994). Volumes 1–15 have been published; additional volumes are in preparation. Cannon’s Procedure in the House of Representatives. By Clarence Cannon, A.M., LL.B., LL.D., Member of Congress, sometime Parliamentarian of the House, Speaker pro tempore, Chairman of the Committee of the Whole, Chairman of the Committee on Appropriations, and so on. House Practice, A Guide to the Rules, Precedents and Procedures of the House. By Wm. Holmes Brown, Parliamentarian of the House (1974–1994). Procedure in the U.S. House of Representatives, Fourth Edition (1982) (1987 Suppl.). By Lewis Deschler, J.D., D.J., M.P.L., LL.D., Parliamentarian of the House (1928–1974), and Wm. Holmes Brown, Parliamentarian of the House (1974–1994). Senate Procedure. By Floyd M. Riddick, Parliamentarian Emeritus of the Senate, Alan S. Frumin, Parliamentarian of the Senate; Senate Document 101-28 (1992). Calendars of the House of Representatives and History of Legislation. Published each day the House is in session; prepared under the direction of the Clerk of the House of Representatives. Committee Calendars. Published periodically by most of the standing committees of the House of Representatives and Senate, containing the history of bills and resolutions referred to the particular committee. Digest of Public General Bills and Resolutions. A brief synopsis of public bills and resolutions, and changes made therein during the legislative process; prepared by American Law Division, Congressional Research Service, Library of Congress.

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Congressional Record. Proceedings and debates of the House and Senate, published daily, and bound with an index and history of bills and resolutions at the conclusion of each session of the Congress. The record of debates prior to 1874 was published in the Annals of Congress (1789–1824), The Register of Debates (1824–1837), and the Congressional Globe (1833–1873). Journal of the House of Representatives. Official record of the proceedings of the House, published at the conclusion of each session under the direction of the Clerk of the House. Journal of the United States Senate. Official record of the proceedings of the Senate, published at the conclusion of each session under the direction of the Secretary of the Senate. United States Statutes at Large. Contains the laws and concurrent resolutions enacted, and reorganization plans and proclamations promulgated during each session of the Congress, published annually under the direction of the Archivist of the United States by the Office of the Federal Register, National Archives and Records Administration, Washington, DC 20408. Supplemental Volumes: Tables of Laws Affected. Volumes 70–84 (1956–1970), Vols. 85–89 (1971–1975), containing tables of prior laws amended, repealed, or patently affected by provisions of public laws enacted during that period. Additional parts, containing treaties and international agreements other than treaties, were published annually under the direction of the Secretary of State until 1950. United States Code. The general and permanent laws of the United States in force on the day preceding the commencement of the session following the last session, the legislation of which is included: arranged in 50 titles; prepared under the direction and supervision of the Law Revision Counsel of the House of Representatives. New editions are published every 6 years, and cumulative supplements are published annually. Federal Register. Presidential Proclamations, Executive Orders, and federal agency orders, regulations, and notices, and general documents of public applicability and legal effect, published daily. The regulations therein amend the Code of Federal Regulations. Published by the Office of the Federal Register, National Archives and Records Administration, Washington, DC 20408. Code of Federal Regulations. Cumulates in bound volumes the general and permanent rules and regulations of federal agencies published in the Federal Register, including Presidential documents. Each volume of the Code is revised at least once each calendar year and issued on a quarterly basis. Published by the Office of the Federal Register, National Archives and Records Administration, Washington, DC 20408. Weekly Compilation of Presidential Documents. Contains statements, messages, and other presidential materials released by the White House during the

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previous week, published every Monday by the Office of the Federal Register, National Archives and Records Administration, Washington, DC 20408. History of the United States House of Representatives. Prepared by Congressional Research Service, Library of Congress, House Document 103-324. The Senate, 1789–1989, Addresses on the History of the United States Senate, Vol. 1. By Senator Robert C. Byrd, Senate Document 100-20 (1988). Historical Almanac of the United States Senate. By Senator Bob Dole, Senate Document 100-35 (1989).

Appendix F ENACTMENT OF A LAW ROBERT B. DOVE Parliamentarian, U.S. Senate

Introduction Continuing Procedures of the Senate Forms of Legislative Business Origins of Legislation Beginning a Daily Session of the Senate Calendar and Legislative Days Morning Hour and Morning Business Presenting Measures Motions, Quorums, and Votes Motions Quorums Voting Senate Officials on the Floor Senate Committee Consideration Committee Rules Committee Reports Considering Measures on the Senate Floor The Amendment Process Final Passage Engrossment and Transmittal to the House House Committee Consideration House Floor Action Messages and Amendments between the Houses Senate Action on House Amendments Bill Originating in the House Drinking Water Regulation and Health, Edited by Frederick W. Pontius. ISBN 0-471-41554-5 # 2003 John Wiley & Sons, Inc.

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Conference Committees and Reports Senate and House Action on Conference Reports Signatures of Speaker and Vice President Presidential Action—Approval or Veto The Congressional Budget Process Executive Business and Executive Sessions Executive Matters Generally Nominations Treaties Amendments, Reservations, and Other Statements Ratification of Treaties

INTRODUCTION The legislative branch of government has responsibilities that in many cases transcend the process of enactment of legislation. Among these are the Senate’s power of advice and consent with regard to treaties and nominations. The preeminent role of the legislative branch, however, is its concern with legislation. ‘‘All legislative Powers’’ granted to the federal government by the Constitution, as stated in Article I, Section I, are vested in a Congress of the United States, which shall consist of a Senate and House of Representatives. The Congress meets at least once a year and has been doing so since 1789 in the following locations: from March 4, 1789 through August 12, 1790, in Federal Hall, New York, New York; from December 6, 1790 through December 2, 1799, in Congress Hall, Philadelphia, Pennsylvania; and from November 17, 1800, at the Capitol, in Washington, DC. Since the Constitution prescribes that there be two Senators from each state, the Senate is presently composed of 100 Members. Also pursuant to the Constitution, a Senator must be at least 30 years of age, have been a citizen of the United States for 9 years, and, when elected, be a resident of the state where elected. The term of office is 6 years and approximately one-third of the total membership of the Senate is elected every second year.

CONTINUING PROCEDURES OF THE SENATE The order of business in the Senate is simpler than that of the House. While the procedure of both bodies is basically founded on Jefferson’s Manual of Parliamentary Practice, the practices of the two bodies are at considerable variance. The order and privileged status of motions and the amending procedure of the two are at less variance than their method of calling up business. The business of the Senate (bills and resolutions) is not divided into classes as a basis for their consideration, nor are calendar days set aside each month in the Senate for consideration of particular bills

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and resolutions. The nature of bills has no effect on the order or time of their initial consideration. The Senate, like the House, gives certain motions a more privileged status than others, and certain business, such as conference reports, command first or immediate consideration, under the theory that a bill that has reached the conference stage has been moved a long way toward enactment and should be privileged when compared with bills that have only been reported. At any time the Presiding Officer may lay, or a Senator may move to lay, before the Senate any bill or other matter sent to the Senate by the President or the House of Representatives, and any pending question or business at that time shall be suspended, but not displaced. Included in this category are veto messages, which constitute privileged business and that may be brought up at almost any time; however, a Senator cannot be deprived of the right to the floor for this purpose nor may certain business be interrupted, such as approving the Journal, while the Senate is dividing ‘‘or while a question of order or a motion to adjourn is pending.’’ The Senate is a continuing body as contrasted with the House. Two-thirds of the Senators of an old Congress return to the subsequent new one without having to be reelected, but all Representatives must stand for reelection every 2 years. Thus the manner and extent of organizing each new Senate have not been established under the influence of definite breaks between each Congress as has been the experience of the House, nor have the parliamentary rules of the Senate been equally subjected to alterations. Representatives readopt their old rules of procedure at the inception of each Congress, often with slight modification, while Senators have not given a general reaffirmation to their rules since 1789. The rules adopted by the Senate in the first Congresses have remained in force continuously, with the exceptions of particular additions or abolishments from time to time. Any such changes are made by amending the rules to meet new needs of the body. Changes have not been frequent, as demonstrated by the fact that a codification of the accumulated alterations has occurred on only a few different occasions. The continuity of sessions of the same Congress is provided for by the Senate rules: ‘‘At the second or any subsequent session of a Congress, the legislative business of the Senate which remained undetermined at the close of the next preceding session of that Congress shall be resumed and proceeded with in the same manner as if no adjournment of the Senate had taken place’’ (Rule XVIII). In its rules and practices, the Senate always has emphasized the importance of maintaining decorum in its proceedings: At no stage of the Senate’s proceedings may a Senator ‘‘refer offensively to any State of the Union.’’ . . . No Senator in debate shall, directly or indirectly, by any form of words impute to another Senator or to other Senators any conduct or motive unworthy or unbecoming a Senator. . . . No Senator shall interrupt another in debate without his consent, and to obtain such consent he shall first address the Presiding Officer; and no Senator shall speak more than twice upon any one question in debate on the same day without leave of the Senate, which shall be determined without debate. . . . If any Senator, in speaking or otherwise, transgress the rules of the Senate, the Presiding officer shall, or any Senator may, call him to order; and when a Senator shall be called

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to order he shall sit down, and not proceed without leave of the Senate, which, if granted, shall be upon motion that he be allowed to proceed in order, which motion shall be determined without debate.

FORMS OF LEGISLATIVE BUSINESS All proposed legislation, and nearly all formal actions by either of the two Houses, take the form of a bill or resolution. A bill is a legislative proposal of a general nature. A bill may propose either a public or private matter, but both are numbered in the same sequence. Public bills are the most numerous. Private bills are designed to affect or benefit specific individuals or groups of individuals. Together, bills account for a large majority of the total of legislative proposals of each Congress. The Senate numbers bills in sequence starting with number 1, and each number is preceded by the designation ‘‘S’’. House bills are similarly numbered and prefaced by ‘‘H.R.’’ Thus, bill number 100 in the Senate is written S. 100, and in the House, H.R. 100. Joint resolutions, which have the same effect as bills unless they are used to propose amendments to the Constitution, are designated ‘‘S.J. Res.—.’’ Concurrent resolutions, which are designated ‘‘S. Con. Res.—’’ for Senate concurrent resolutions, are chosen to express the sense of the Congress to the President or other parties; to attend to ‘‘housekeeping’’ matters affecting both Houses, such as the creation of a joint committee; or to carry proposals to correct the language of measures passed by one House (an engrossment) or both Houses (an enrollment). All concurrent resolutions, including corrective resolutions, must be agreed to in both the Senate and House. One House may seek to correct a measure it passed, or both Houses may wish to correct a measure awaiting the President’s signature. The former may be accomplished merely by specifying what changes or additions are to be made and requesting the other House to make them, or requesting the return of the measure to the originating House for that purpose. Correction of measures already sent to the President, however, are made after agreement of both Houses to concurrent resolutions requesting return of the measures from the White House. Such resolutions include a resolve that if and when a measure is returned, the action of the Presiding Officers of the two Houses in signing the measure shall be deemed rescinded, and the Secretary of the Senate or the Clerk of the House is authorized and directed in the reenrollment of the measure to make the necessary corrections. The corrected measure (bill or joint resolution) is then again signed by the Secretary of the Senate or the Clerk of the House, the Speaker, and the Vice President and again delivered to the White House. Finally there is the designation of ‘‘S. Res.—’’ for Senate resolutions, which are used primarily to express the sense of the Senate only, or to take care of ‘‘housekeeping’’ matters, including changes in rules, that apply only to the Senate. When the question of agreement to, or formal acceptance of, a resolution is raised, concurrent and simple resolutions are agreed to or adopted, whereas bills and joint resolutions are passed. In the House of Representatives, measures have the following designations: ‘‘H.R.—,’’ for House bills; ‘‘H.J. Res.—,’’ for House joint resolutions; ‘‘H. Con.

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Res.—,’’ for House concurrent resolutions; and ‘‘H. Res.—,’’ for House resolutions. Bills and resolutions are numbered ad seriatim, in the chronological order in which they are introduced or submitted. Senate and House bills and joint resolutions, when passed by both Houses in identical form and approved by the President, become public or private law—public laws affect the nation as a whole; private laws benefit only an individual or a class thereof. The procedure on each is identical, with the exception of joint resolutions proposing amendments to the Constitution of the United States, which under the Constitution must be passed in each House by a two-thirds vote of the Members present and voting, a quorum being present. They are not sent to the President for his approval but to the Administrator of the General Services Administration, who transmits them to the various states. Constitutional amendments are valid when ratified by at least three-fourths of the states. Concurrent resolutions have the force of both Houses and must be approved by them in identical form to be effective. However, they are not presented to the White House for the President’s signature, because they do not become law. They are not signed by the President nor by the Speaker and the Vice President. Instead, they are attested by the Secretary of the Senate and Clerk of the House and transmitted after approval to the Administrator of the General Services Administration for publication in the Statutes at Large. A House or Senate resolution (H. Res.— or S. Res.—) only has the force of the House passing it, and action by the one House is all that is necessary.

ORIGINS OF LEGISLATION Legislation originates in several ways. The Constitution provides that the President ‘‘shall from time to time give to the Congress Information of the State of the Union, and recommend to their Consideration such Measures as he shall judge necessary and expedient.’’ The President fulfills this duty either by personally addressing a joint session of the two Houses or by sending messages in writing to Congress, or to either body thereof, which are received and referred to the appropriate committees. The President usually presents or submits his annual message on the state of the Union shortly after the beginning of a session. In addition, many executive communications are sent to Congress. These are documents signed by the President or by an agency or department head, and filed or submitted as a report to the Senate as directed by law or otherwise. These items are numbered sequentially for a Congress and assigned the prefix EC. They are described only by a brief statement of the contents in the Congressional Record. The right of petition is guaranteed the citizens of the United States by the Constitution, and many individual petitions as well as memorials from state legislatures are sent to Congress. They are laid before the two Houses by their respective Presiding Officers or submitted by individual Members of the House and Senate in their respective bodies, and are usually referred to the appropriate committees of the House in which they were submitted. Bills to carry out the recommendations of the President are usually introduced ‘‘by request’’ by the chairmen of the various

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committees or subcommittees thereof that have jurisdiction of the subject matter. Sometimes the committees themselves may submit and report to the Senate ‘‘original bills’’ to carry out such recommendations. The ideas for legislative proposals may come from an individual Representative or Senator, from any of the executive departments of the government, from private organized groups or associations, or from any individual citizen. However, they can be introduced in their respective Houses only by Senators and Representatives. When introduced, they are referred to the standing committees that have jurisdiction over the subject matter. Members frequently introduce bills that are similar in purpose, in which case the committee considering them may add to one of the bills the best features of the others for reporting to the parent body, or draft an entirely new bill (known as an ‘‘original bill’’) and report it in lieu of the others.

BEGINNING A DAILY SESSION OF THE SENATE Each day in the Senate begins as the Secretary of the Senate and the Presiding Officer for that day escort the Chaplain of the Senate or guest chaplain to the desk. The Chaplain is a clergy member chosen by the Senate, whose responsibility is to offer the prayer at the opening of each daily session, as well as to officiate at various ceremonies and respond to Senators’ private needs.

Calendar and Legislative Days As the Senate begins its new day, it is important to note that the Senate recognizes two meanings for the word ‘‘day,’’ the ‘‘calendar’’ day, and the ‘‘legislative’’ day. A calendar day is recognized as each 24-hour period. Reference may be made to a day certain, as in a unanimous consent request to vote on passage of a measure on August 4, 1989 (a specific, determined, or fixed day), or a day not yet determined, as in a unanimous consent request or rule requiring action ‘‘on either of the next two days of actual session.’’ The references in these cases are to calendar days. A legislative day is the period of time following an adjournment of the Senate until another adjournment. A recess (rather than an adjournment) in no way affects a legislative day; therefore, one legislative day may consume a considerable period of time—days, weeks, even months—but one or more adjournments from one day to the next would cause the calendar and legislative day to coincide. As used in the Rules of the Senate, a day generally is recognized as a legislative day unless specified as a calendar day. There is, for example, the proviso that ‘‘no Senator shall speak more than twice upon any one question in debate on the same legislative day’’ in Rule XIX. However, Rule V, disallowing motions ‘‘to suspend, modify or amend any rule . . . , except on one day’s notice in writing,’’ although not specifying the type of day, is interpreted as meaning one calendar day.

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Morning Hour and Morning Business The Senate Majority Leader by unanimous consent customarily provides for a brief period of time (usually 10 minutes each) at the beginning of each daily session for him(her)self and the Minority Leader to be used at their discretion for observations on current events or pending legislation, submission and agreement of various legislative matters. They may yield all or part of their time to their Senators for sundry purposes. It is with these orders that the day of the Senate begins. During the morning hour of each legislative day, Rule VII of the Senate provides that, after the Journal is read, the Presiding Officer lay before the Senate messages, reports, and communications of various types. Measures or matters are transmitted between the two Houses, as are written messages from one House to the other pertaining to the passage of measures or other conduct of official business requiring concurrence or notification. The President of the United States transmits written messages to the Congress, which are brought to the Chamber and announced to the Senate by a messenger from the White House. Such messages are numbered sequentially for a Congress and assigned a prefix PM. They are printed in full in the Congressional Record. Messages from the President may be received at any stage of Senate proceedings, except during votes or quorum calls, while the Journal is being read, or while a question of order or a motion to adjourn is pending. The Presiding Officer then calls for the ‘‘presentation of petitions and memorials.’’ These are documents memorializing the government to do or not to do something. Memorials and petitions when laid before the Senate are numbered and assigned a prefix POM, and all memorials and petitions from state, territorial, and insular possession legislatures or conventions, lawfully called, are printed in full in the Record when presented. Those received from other memorialists or petitioners are described only by a brief statement of the contents. Next the Presiding Officer calls for the filing of reports of committees, the introduction of bills and joint resolutions, and the submission of other resolutions. Under more recent practices, however, nearly all bills, resolutions, and committee reports are presented by Senators to the clerks at the Presiding Officer’s desk for processing throughout the day, and without any comments from the floor.

Presenting Measures The Majority Leader customarily secures unanimous consent at the beginning of each new Congress to allow receipt at the desk of all measures on days when morning business is conducted. Such permission allows Senators to bring measures to the desk at any time during the day, instead of following the procedure as set forth in Rule VII, requiring introduction of bills and joint resolutions only on a new legislative day during the transaction of morning business, followed by submission of other resolutions. Bills and resolutions still may be introduced from the floor, however, and any Senator, when doing so, usually discusses the proposal when presenting it. There can be only one prime sponsor of a bill or resolution, but commonly other Senators are included as cosponsors.

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The Senate’s rules make no mention of multiple sponsorship, which has been a common practice for many years. Although custom permits unlimited numbers of Senators to sponsor a wide assortment of measures, it prohibits more than one Member’s name to appear on a reported bill or resolution and the printed report accompanying it. Cosponsors are often shown on measures as introduced, but other names may be added, by unanimous consent, at their next printing. Since its inception, the advisability of multiple sponsorship has been questioned by many Senators, and others have submitted resolutions to abolish the practice. The Committee on Rules and Administration has held hearings and favorably reported measures to amend the Rules to prohibit joint sponsorship, except under limited conditions, but to date, the full Senate has not voted its approval or disapproval. A former practice of holding measures at the desk for days, to permit the addition of names, has often met considerable opposition and was discontinued in the 1960s. Measures can be submitted with the phrase ‘‘by request,’’ a term found following the names of the sponsors of bills and resolutions that are introduced or submitted at the request of the Administration or private organizations or individuals. Such proposals, although introduced as a courtesy, are not necessarily favored by the Senators sponsoring them. Drafts of proposed legislation from the President or an executive agency are usually introduced by the chairman of the committee of jurisdiction, who may be of the opposition party.

MOTIONS, QUORUMS, AND VOTES Motions The motions that ‘‘shall be received’’ under Rule XXII when ‘‘a question is pending’’ and that ‘‘shall have precedence as they stand arranged’’ are To adjourn To adjourn to a day certain, or that when the Senate adjourn it shall be to a day certain To take a recess To proceed to the consideration of executive business To lay on the table To postpone indefinitely To postpone to a day certain To commit To amend All except the last four of these motions are not debatable. The motion to adjourn should be distinguished from a resolution to adjourn both houses of Congress. Neither is debatable. The Senate may adjourn for as long a period of time as it sees fit, up to the Constitutional limitation of 3 days, without the consent of the other

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House, or it may adjourn for only a few minutes and reconvene on a new legislative day in the same calendar day. The motion to lay on the table is a simple way of taking final action on pending business on which the Senate wishes to take a negative position. It is applicable to a bill and amendments thereto as well as to certain motions. An amendment can be laid on the table without prejudice to the bill to which it was offered, but an amendment to the amendment would also go to the table. Since the motion is not debatable, the question can be brought to a vote in a hurry. The motion is used generally to reach a final disposition on motions to reconsider or appeals from the decision of the chair. While the motion is applicable to pending business, it is seldom used for the disposition of legislation—bills are generally voted either up or down. The preamble to a bill or resolution may be laid on the table without carrying the bill or resolution with it. The motion to postpone indefinitely is the next in order, but it is rarely used to dispose of bills except in the case of companion bills; for instance, the Senate passes a House-passed bill and indefinitely postpones a companion Senate bill that has been reported and placed on the calendar. It is a way of effecting a final disposition of a measure. The motion to postpone to a day certain is also used by the Senate. These motions are debatable and amendable and take precedence over a motion to refer or commit. A motion to take up another bill while unfinished business is pending has precedence over a motion to postpone the unfinished business to a day certain. A motion to recommit a bill to committee with instructions to report the bill back forthwith with an amendment, if agreed to, requires that the committee report the bill back to the Senate immediately with that proposed amendment which is then before the Senate for consideration. The last of this series of motions that shall be received under Rule XXII, ‘‘when a question is pending,’’ and in the order listed above, is ‘‘to amend.’’ Any bill, or amendment thereto, before the Senate is open to amendment.

Quorums If, at any time during the daily sessions of the Senate, a question shall be raised by any Senator as to the presence of a quorum, the Presiding Officer shall forthwith direct the Secretary to call the roll and shall announce the result, and these proceedings shall be without debate. . . . Whenever upon such roll call it shall be ascertained that a quorum is not present, a majority of the Senators present may direct the Sergeant at Arms to request, and, when necessary, to compel the attendance of the absent Senators, which order shall be determined without debate; and pending its execution, and until a quorum shall be present, no debate nor motion, except to adjourn, shall be in order.

The Senate proceeds under the assumption that a quorum is present unless the question is raised; in that case, the bells are rung to inform the ‘‘absentee’’ Senators and the Presiding Officer directs a call of the roll. All decisions incident thereto are made without debate, and if a quorum is not present by the time the results from the roll call are announced, a majority of the Senators present may direct the Sergeant at Arms to request or compel the attendance of the absent Senators. Senators may be forced to attend, unless granted a ‘‘leave of absence’’ or by authority of

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the Senate, even if a quorum is present. Senators who do not reach the chamber when the roll is being called in time to answer to their names may gain recognition after the call and have their presence or vote recorded, provided the results have not been announced. Under the practice of the Senate, anyone, once recognized, can request a quorum call, but a Senator who has the floor cannot be forced to yield to another for that purpose. The chair is not permitted to count in order to ascertain the presence of a quorum; it must be determined by roll call. There is no limit to the number of requests for quorum calls that may be made during the course of a day; a request is generally held dilatory if no business has transpired since the last one, and it is not in order immediately after a roll call vote showing that a quorum is present. The reception of a message from the House has not been ruled as the transaction of business sufficient to justify a quorum call. The following have been ruled to be business: the ordering of engrossment and third reading of a joint resolution, presentation and reference of a communication, granting of permission to insert an article in the Record, objection to a bill under call of the calendar under Rule VIII, the making of a motion or ordering of the yeas and nays, voting on motions to recess, adjourn, and lay on table and on an appeal from the decision of the chair, the offering of an amendment, agreeing to a motion for an executive session, and submitting a report out of order. A motion may be made to request attendance of those absent, and instructions to compel their attendance may be added. Such a motion is not debatable. A quorum call on various occasions has been withdrawn by unanimous consent while the roll was being called; but when an announcement of no quorum has been made, it is not in order to vacate the call even by unanimous consent. In the absence of a quorum, neither debate nor the transaction of business, including motions (except the motion to adjourn), is in order; it is not even in order to move to recess.

Voting Rule XII, relating to voting, provides 1. When the yeas and nays are ordered, the names of Senators shall be called alphabetically; and each Senator shall, without debate, declare his assent or dissent to the question, unless excused by the Senate, and no Senator shall be permitted to vote after the decision shall have been announced by the Presiding Officer, but may for sufficient reasons, with unanimous consent, change or withdraw his vote. No motion to suspend this rule shall be in order, nor shall the Presiding Officer entertain any request to suspend it by unanimous consent. 2. When a Senator declines to vote on call of his (her) name, he (she) shall be required to assign his reasons therefore, and having assigned them, the Presiding Officer shall submit the question to the Senate: ‘‘Shall the Senator, for the reasons assigned by him, be excused from voting?’’ which shall be

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decided without debate; and these proceedings shall be had after the roll call and before the result is announced; and any further proceedings in reference thereto shall be after such announcement. Any one of the several methods of voting utilized by the Senate may be resorted to for final disposition of any amendment or bill or question. The methods are as follows: voice vote, division, and yea=nay. The yeas and nays may be ordered when the request is seconded by one-fifth of a presumptive quorum, but frequently the Presiding Officer does not bother to count but merely glances at the ‘‘showing’’ of hands and orders the call; simultaneously the bells ring in both the Senate wing of the Capitol and the Senate office buildings. The names of the Senators are called in alphabetical order. Voting and changes of votes are in order until the decision has been announced by the Chair. A Senator can change his (her) vote at any time before the result is announced. In the case of a veto, a yea=nay vote is required by the Constitution. Otherwise, the Senators may utilize any of the methods. After the result of a vote has been announced, a request for a division or yea and nay vote comes too late; the announcement that the ‘‘ayes (or nays) seem to have it’’ is not a final result. The yeas and nays may be demanded prior to announcement of the results of a division vote. Where less than a quorum votes and the number of pairs announced are not sufficient to make a quorum, it is the duty of the chair to order a quorum call; the vote is valid if a quorum was present, even if a quorum did not vote, provided a number of those not voting, sufficient to make a quorum, announced they were present but paired. ‘‘Pairing’’ is the practice that has been developed in both houses to enable Representatives and Senators to register their opinions on any particular issue or issues when they are unavoidably absent from the chamber on public or private business. By the use of ‘‘pairs’’ a Senator (or Representative) favoring a particular issue, and who is absent when a roll call vote is taken on it, may make his (her) opinion effective by contracting (pairing) with a colleague opposing the issue that neither of the Senators will vote. ‘‘Pairs’’ are not counted as yeas or nays in the official tabulation of the roll call for the purpose of determining the adoption or rejection of the issue being voted on. After all amendments to an original amendment to a bill have been disposed of, the question recurs on the adoption of the amendment as amended, if amended. After all amendments to a bill have been acted on, the question recurs on third reading and passage of the bill. After the Senate acts on an amendment or on a bill, or almost any question on which the Senate has voted, any Senator voting on the side that prevailed may offer a motion to reconsider the vote by which that action was taken. A Senator voting in the minority cannot move to reconsider a yea=nay vote; but may do so if he (she) did not vote.

SENATE OFFICIALS ON THE FLOOR Various officials are present on the floor of the Senate when it convenes, including the Majority and Minority Leaders of the Senate, the Secretary and Assistant

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Secretary of the Senate, the Sergeant at Arms, the Legislative Clerk, the Journal Clerk, the Parliamentarian of the Senate, the Secretaries for the Majority and the Minority, the Official Reporters of Debate, and the pages. The Secretary of the Senate is the elected official of the Senate responsible for management of many legislative and administrative services. The Secretary is the disbursing officer for the Senate. The official seal of the Senate is in the custody of, and its use is prescribed by, the Secretary. In the absence of the Vice President, and pending the election of a President pro tempore, the Secretary performs the duties of the Chair. The Assistant Secretary is the chief assistant to the Secretary of the Senate. The Assistant Secretary performs the functions of the Secretary in the latter’s absence, and in the event of the death or resignation of the Secretary would act as Secretary in all matters except those duties as disbursing officer of the Senate. On the day after the first organization of the Senate, a Doorkeeper was chosen whose title was eventually changed to Sergeant at Arms. His duties are to execute the Senate’s orders as to decorum on the floor and in the galleries, responsibility for enforcement of all rules made for the regulation of the Senate wing of the Capitol, serving as custodian of all properties under the dominion of the Senate, and supervision of the messengers, pages, and other workers who serve the Senate. If the Senate decides to issue warrants of arrest for its absent Members, it is the duty of the Sergeant at Arms to bring those Senators into custody. Article 1, Section 5, paragraph 3 of the Constitution provides that ‘‘Each House shall keep a Journal of its Proceedings, and from time to time publish the same, excepting such Parts as may in their Judgment require Secrecy; and the Yeas and Nays of the Members of either House and any question shall, at the Desire of onefifth of those Present be entered on the Journal.’’ The Journal Clerk is charged with maintaining the Senate Journal under the direction of the Secretary of the Senate. The Legislative Clerk is responsible for reporting all bills, messages from the House, conference reports, and amendments to the Senate. All record votes are taken by the Legislative Clerk and his (her) assistants. An appointed official of the Senate, the Parliamentarian functions under the direction of the Secretary of the Senate. The Parliamentarian’s chief duty and responsibility is to advise the Presiding Officer on parliamentary aspects of Senate activity. The Parliamentarian advises Senators and senatorial committee staffs, and is called on by other branches of government, the press, and the public for information regarding procedural aspects of Senate activity. The Official Reporters of Debates prepare the material concerning business of the Senate for inclusion in the Congressional Record. All proceedings in the Senate Chamber are reported verbatim by a staff of Official Reporters, who are under the supervision of the Editor-in-Chief. The Editor-in-Chief is the editor of all matter contained in the Senate proceedings. In addition to the verbatim proceedings in the Senate Chamber, the office of the Official Reporters processes for inclusion in the Congressional Record a description of the morning business conducted by the Senate (measures introduced, messages from the President and the House of Representatives, cosponsors, communications received, and notices of hearings), and additional or

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unspoken statements of Senators. The Official Reporters of Debates are appointed by the Secretary of the Senate. The Secretary for the Majority is an elected officer of the Senate who is responsible for providing many support services to the majority party leaders and members of the Senate. The floor-related duties of the Secretary include supervising the cloakroom, briefing Senators on votes and issues that are under consideration on the floor, obtaining pairs for Senators, and polling Senators when the Leadership so desires. Additionally, the Secretary is responsible for assigning Senate Chamber seats to the majority party Members; maintaining a file of committee assignment requests; staffing the committee that arranges majority party committee assignments; recommending to the Leadership majority party candidates for appointment to boards, commissions, and international conferences; maintaining records of such appointments; providing a repository for official minutes of majority party conferences and meetings of the Policy Committee, Steering Committee, and committee chairmen; monitoring the nominations on the Executive Calendar; and other duties as directed by the Leadership. The Secretary for the Minority also is an elected officer of the Senate, and performs corresponding duties for the minority party leaders and other Senators. The Republican Legislative Scheduling Office provides floor assistance to Republican Senators. The staff serves as a liaison between Republican Senators and the Republican leadership in dealing with Senators’ legislative interests, unanimous consent requests, time agreements, and the scheduling of the Senate’s proceedings. When the Republicans are in the majority, the Republican Legislative Scheduling Office also schedules Republican Senators to preside over the Senate. Floor assistance for Democratic Senators is provided by the staff of the Democratic Policy Committee. This staff is available to provide information regarding the scheduling of legislation and to act as liaison between the legislative committees and the Democratic leadership. Assistance is given in the arrangement of unanimous consent requests on time agreements, amendments, and procedural issues on legislation being debated by the Senate. In addition, the staff provides advice on general parliamentary situations. The Democratic Policy Committee provides other services to Democratic Senators, including detailed voting records for each Democratic Senator, an annual report on the major achievements of the session, and an extensive index of record votes on legislation, both chronologically and by subject matter, and briefings on major bills and amendments. Its counterpart, the Senate Republican Policy Committee, provides similar services for Republican Senators: maintenance of a research library; publication of legislative notices summarizing bills and resolutions on the Senate Calendar and proposed amendments thereto; publication of detailed analysis of all Senate record votes plus indexes, annual abstracts, and lists of voice votes; publication of the weekly Republican Counsel’s Report; publication of policy papers on major issues; development of Republican legislative initiatives; research, legislative analysis, and speech writing for Republican Senators on request; personnel

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placement and counselling; briefing officials from state and local governments on national issues; assisting new Senators with staff orientation; producing the information on the special television channel containing in-house updates on the Senate schedule; and assistance to the party leader in preparation of the End-of-Year Report. Senate pages, male and female, when appointed, must be juniors in high school. They may not be appointed or serve after attaining the age of 17, except that if they are serving and enrolled in the Page School, they may continue their service through the session of the Senate in which the Page School terminates. Riding Page Service is provided by a separate service, through the Senate Post Office, several times a day for delivery of Senators’ letters to major Federal agencies in the District of Columbia only.

SENATE COMMITTEE CONSIDERATION Senate committees are appointed by resolution at the beginning of each Congress, with power to continue and act until their successors are appointed. All Senate committees are created by the Senate. At present, Senate committees include 16 standing committees, 3 select committees, and 1 special committee. Standing committees are charged to report by bill or otherwise on matters within a defined jurisdiction and generally to study and review, on a comprehensive basis, certain matters relating thereto. Select and special committees have varying powers and obligations, and increasingly have been given legislative jurisdiction. In current practice, the committee chairperson is a member of the majority party and is chosen by order of the Senate and is usually, but not always, the senior Member in point of service of the majority Members of the committee. Senate Members may also serve, along with House Members, on joint committees, whose duties and responsibilities are set forth in the respective resolutions or laws creating them. There are currently 4 joint committees of the Congress. Conference committees, appointed when there is disagreement to a measure after passage by both Houses, are composed of Members of both the Senate and the House, like joint committees, but votes in a conference committee are not as a body, but as two delegations.

COMMITTEE RULES Rule XXVI on committee procedure provides that each committee shall adopt rules (not inconsistent with the Standing Rules of the Senate) governing the procedure of such committee. It provides also that the rules of each committee shall be published in the Congressional Record not later than March 1 of each year, except that if any such committee is established on or after February 1 of a year, the rules of that committee during the year of establishment shall be published in the Record within

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60 days. An amendment to a committee’s rules shall be published in the Record not later than 30 days after the adoption of the amendment. Committees as a rule have regular meeting days, but they may meet at the call of their chairpersons or on the request of a majority at other times. At these meetings matters on the committee calendar are usually the order of business, but any matter within the committee’s jurisdiction may be considered—for example, an investigation of an agency of the Government over which the committee has jurisdiction, or a hearing at which an official discusses policies and operations of his (her) agency. Once a bill has been introduced and has been referred by the Presiding Officer with the advice of the Parliamentarian, the clerk of the committee enters it on the committee’s Calendar of Business. Any committee may refer its pending bills to its subcommittees for study and reports thereon. Most of the committees have standing subcommittees, and frequently ad hoc subcommittees are appointed to study and report on particular pieces of legislation or to study a specific subject. Committees or subcommittees generally hold hearings on all major or controversial legislation before drafting the proposal into a final form for reporting to the Senate. The length of hearings and the number of witnesses testifying vary, depending on the time available, the number of witnesses wanting to be heard, the desires of the committee to hear witnesses, and other variables. Recommendations of the Administration, in conjunction with the Office of Management and Budget, are sought by the committees on nearly all major legislation, but they are in no way obligated to accept such recommendations. For example, the Department of Agriculture’s Office of Governmental and Public Affairs, providing liaison between the department and the Congress, would be addressed on a bill relating to inspection of livestock, meat, and agricultural products, and the Office of Congressional Affairs of the General Services Administration would be asked to comment on proposed legislation affecting small business, disadvantaged business, and related subcontracting programs. The responses are often used in support of or against matters pending before the Senate by being quoted on the floor or being inserted in the Record by Senators during debate. A subcommittee makes reports to its full committee, and the latter may adopt such reports without change, amend them in any way it desires, reject them, or adopt an entirely different report. At a committee’s ‘‘markup’’ session, usually held just prior to reporting a bill or resolution back to the full Senate, the committee makes its final decisions about the content and form of the measure. The full committee then may report it to the Senate favorably with or without amendments, submit an adverse report thereon, or vote not to report on anything. The measure can be reported with committee amendments that may (1) insert, (2) strike, (3) strike part of the bill and insert other language, or (4) strike the entire text and insert a complete substitute, thereby rejecting in toto the language of the measure as it was referred to, considered by, and reported by the Senate committee. The desired changes in the measure are indicated in the reprinted measure by use of italic type for additions and line-through type for strike-outs, in contrast to the original introduced form of the measure which is printed in roman type.

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Included may be additions, corrections, or modifications to the preamble of a resolution—the part(s) of a measure prefaced by the word ‘‘Whereas,’’ which precedes the resolving clause. These are voted on after passage or adoption of the measure. Such clauses, which are introductory statements declaring the reasons for and the intent of the legislation, if amended, would reflect changes or modifications contained in the text of the measure. Also, the title may be amended. Committees need not act on all bills referred to them. Under the Senate’s rules, a Senator may enter a motion to discharge a committee from the further consideration of any bill, but this is rarely done. By unanimous consent, some bills are discharged from one committee and sent to another. If a motion to discharge is agreed to, the bill is thereby taken out of the jurisdiction of that committee and placed on the Senate Calendar of Business. It may subsequently be referred to another committee.

COMMITTEE REPORTS The chairperson, or some other member of the committee designated for that purpose, reports bills to the Senate, and when reported they are placed on the Senate Calendar of Business, unless unanimous consent is given for immediate consideration. The action taken by the committee appears on the copy of the bill reported, and a written report, which is numbered ad seriatim, nearly always accompanies the bill. The reports, like the bills, are printed by the Government Printing Office for distribution. A reported bill passes through the same channels in the Secretary’s Office as an introduced bill, for notation of the proper entries in the Senate’s official records. The bill also is reprinted, showing the calendar and report numbers, the name of the Senator reporting it, the date, and whether the committee ordered it reported with or without amendment. Committee members may write their own minority, supplemental, and=or additional views on the bill, and these statements are printed as a part of the committee report on the measure.

CONSIDERING MEASURES ON THE SENATE FLOOR The Senate’s Majority and Minority Leaders, as the spokesmen for their parties, and in consultation with their respective policy committees, implement and direct the legislative schedule and program. Most measures are passed either on the call of the Calendar or by unanimousconsent procedure. The more significant and controversial matters are considered, when possible, under unanimous-consent agreements limiting debate and controlling time on the measure, amendments thereto, and debatable motions relating to it. This is done because otherwise debate is unlimited. Measures may be brought up on motion by a simple majority vote if they have been on the Calendar one legislative day. Such a motion to proceed is usually made by the Majority Leader or his (her)

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designee and is usually debatable. The motion to proceed to the consideration of a measure on the Calendar is usually only made if there has been objection to a unanimous consent request to proceed to its consideration. On highly controversial matters, the Senate frequently has to resort to cloture to work its will. Under Rule XXII, if three-fifths of the Senators duly chosen and sworn (60 if the Senate is at full membership of 100) vote in the affirmative, further debate on the question shall be limited to no more than one hour for each Senator, and the time for consideration of the matter shall be limited to 30 additional hours, unless increased by another three-fifths vote. On a measure or motion to amend the Senate Rules, it takes two-thirds of the Senators present and voting, with a quorum present, to invoke cloture. Under Rule VIII, which governs the consideration of bills on the call of the Senate Calendar, there is supposed to be a Calendar call each day at the end of the morning business. Under current practice, however, this very rarely occurs; instead, the Calendar is usually called, if at all, pursuant to a unanimous consent order. Rule VII makes a call of the Calendar mandatory on Monday if the Senate had adjourned after its prior sitting. This requirement may be waived only by unanimous consent, and it has become the regular practice of the leadership to request that the requirement be waived.

THE AMENDMENT PROCESS Once a bill or resolution is before the Senate, it is subject to the amendatory process, both by the committee reporting it and by individual Senators offering amendments from the floor. A committee amendment reported as a total substitute (striking all after the enacting clause and inserting new language for the entire bill) for the pending measure is always voted on last, inasmuch as once a total substitute is agreed to, further amendments are precluded. With this exception, however, committee amendments take priority and are considered in order as they appear in the printed copy of the measure before the Senate. The only amendments from the floor in order during the consideration of these committee amendments are amendments to the committee amendments or sometimes to the part of the bill that the committee amendments would affect. Once the committee amendments have been disposed of, however, any Senator may propose amendments to any part of the bill not already amended, and while an amendment is pending, an amendment to the amendment is in order. By precedent, an amendment to an amendment to an amendment, which is an amendment in the ‘‘third degree’’, is not in order. However, the first amendment in the nature of a substitute for a bill, whether reported by a committee or offered by an individual Senator, is considered an original question and is amendable in two more degrees. Certain special procedures in the Senate limit the amendatory process. For example, during the consideration of general appropriation bills, amendments are subject to the strictures of Rule XVI under which it is not in order to offer nongermane amendments or amendments proposing new or general legislation or increasing the

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amount of an appropriation if that increase has not been previously authorized or estimated for in the President’s budget. Likewise, when operating under a general unanimous consent agreement in the usual form on a bill or resolution, amendments must be germane. Germaneness of amendments is also required once the Senate has invoked cloture; in addition, any amendments considered under cloture must have been submitted in writing before the Senate’s vote on cloture.

FINAL PASSAGE When all committee amendments and all Senators’ floor amendments have been disposed of, the bill is ordered engrossed and read a third time, which step ends the amendatory process. The third reading is by title only. The question is then put on passage of the bill, which requires a simple majority vote. If a resolution has a preamble, it may be agreed to, amended, or stricken out after the resolution has been adopted. The title to a bill is also acted on after its passage; the title may be amended if amendments made to the bill necessitate such a change. At any time before its passage, a bill may be laid on the table or postponed indefinitely, either of which motions has the effect of killing the bill; alternatively, a bill may be made a special order for a certain day, which requires a two-thirds vote; laid aside temporarily; recommitted to the committee that reported the bill; referred to a different committee; or displaced by taking up another bill by a majority vote. Most bills are passed by a voice vote only, but where a doubt is raised in such a case, the Presiding Officer, or any Senator, before the result is announced, may request a division of the Senate to determine the question. Before the result of a voice or division vote has been announced, a roll call vote may take place on the demand of one-fifth of the Senators present, but at least 11—one-fifth of the presumptive quorum of 51. In the case of a yea=nay vote, any Senator who voted with the prevailing side or who did not vote may, on the same calendar day or on either of the next 2 days the Senate is actually in session, make a motion to reconsider the question. On a voice vote or division vote, however, any Senator may make the motion. If made before other business intervenes, it may be proceeded with and is debatable. It may be laid on the table without prejudice to the main question and is a final disposition of the motion. A majority vote determines questions of reconsideration. If the motion is agreed to, another vote may be taken on the question reconsidered; if disagreed to, the first decision of the Senate is affirmed. The making of such a motion is privileged but may not be done while another matter is pending before the Senate. Only one motion to reconsider the same question is in order. Such a motion, under Rule XXI, may be withdrawn by the mover by leave of the Senate, which may be granted by a majority vote or by unanimous consent. A bill cannot be transmitted to the House of Representatives while a motion to reconsider remains unacted upon.

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ENGROSSMENT AND TRANSMITTAL TO THE HOUSE The printed bill used at the desk by the Senate during its consideration is the official desk copy, showing the amendments adopted, if any. Once it is endorsed as having passed, it is sent to the Secretary’s Office and delivered to the Bill Clerk. After making the proper entries on his (her) records and the data retrieval system, the Bill Clerk turns it over to the Enrolling Clerk, who makes an appropriate entry on his (her) records and sends it to the Government Printing Office to be printed on special white paper in the form in which it passed the Senate. This printed Act is attested by the Secretary as having passed the Senate as of the proper date, and is termed the ‘‘official engrossed bill.’’ After the passage of a bill by one body, it technically becomes an Act (which is not yet effective as a law), but it nevertheless continues to generally be referred to as a bill. Engrossed bills are transmitted, or ‘‘messaged,’’ to the House of Representatives by one of the clerks in the Secretary’s Office, who is announced by one of the House’s officials. On being recognized by the Speaker, the clerk announces that the Senate has passed a bill (giving its number and title) in which the concurrence of the House is requested. On receipt of such a message from the Senate, the Speaker refers the measures contained therein to appropriate committees. If, however, a substantially similar House bill already has been favorably reported by a committee, the Senate bill, unless it creates a charge on the Treasury, may remain on the Speaker’s table instead of being referred to committee. It may subsequently be taken up or its text may be substituted for that of the House bill when consideration of the latter occurs.

HOUSE COMMITTEE CONSIDERATION Senate bills and resolutions when messaged to the House may be referred by the Speaker to the appropriate House committee, just as he refers all bills and resolutions introduced in the House. If referred, they are processed in much the same fashion as in the Senate—that is, endorsed for reference, recorded in the Journal, listed in the Congressional Record, and printed by the Government Printing Office for distribution. House committees, like Senate committees, have committee calendars of business and regular meeting days (but may also meet on the call of their chairpersons) for the consideration of business pending before them. The procedure of House committees in considering and reporting bills also is much the same as that of the Senate committees; for example, they, too, have standing subcommittees and ad hoc subcommittees. In contrast to the Senate rules, however, House rules allow the Speaker, under some circumstances, to refer a bill to two or more committees in sequence, or to refer parts of the same bill to different committees, when more than one committee has jurisdiction over the subject matter contained in the bill.

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After all House committees having jurisdiction have concluded consideration of a bill, the bill may be reported to the House with or without amendments. A written report accompanies each reported measure. When reported from committee, a bill is placed on the Union or House Calendar, if a public bill, or on the Private Calendar. The House also has a Corrections Calendar, on which are placed bills that are expected to enjoy considerably more than majority support on the floor, and a calendar of motions to discharge committees from further consideration of bills referred to them.

HOUSE FLOOR ACTION The House rules designate special legislative days that have been established to expedite certain types of unprivileged business. The special legislative days are Calendar Wednesday (every Wednesday), District of Columbia (the second and fourth Mondays), suspension of the rules (every Monday and Tuesday), and the Corrections Calendar (the first and third Mondays). Private Calendar business, if any, is considered on the first and third Tuesdays of each month, and discharge motions on the second and fourth Mondays. Generally speaking, after the regular routine business each morning, including the approval of the Journal, the House proceeds to the consideration of whatever bills or resolutions are to be acted on that day. The order varies somewhat, as follows: (1) on days set aside for certain procedures, such as suspension motions on Mondays and Tuesdays, bills and resolutions are called up in pursuance of the procedure, as defined by House rules in each instance; (2) under unanimous consent, bills are called up in pursuance of such requests made and granted by the House, regardless of the regular rules of procedure; and (3) privileged matters, such as general appropriation bills and conference reports, may be called up by the Members in charge of them at almost any time after they have laid over for 3 days, providing the Representative in charge is recognized by the Speaker. The House also can determine the order of its business and decide what bill to take up by adopting a special rule (simple House resolution) reported by the Rules Committee. The procedure for consideration of such measures is defined in each instance in the special rule. A special rule to call up a bill may be debated for an hour before it is voted on. Bills called up under special rules are usually major or controversial pieces of legislation. Bills that are first considered in the Committee of the Whole House on the State of the Union are considered for amendment under the 5-minute rule, after which the Committee of the Whole reports them back to the House for action on any amendments that may have been adopted, and then for the vote on final passage. In the House, as in the Senate, bills are read 3 times before they are passed. After a Senate bill is passed by the House, with or without amendment, it is returned to the Senate; if there are amendments, the amendments are engrossed before being messaged to the Senate. All House engrossments are printed on blue paper.

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MESSAGES AND AMENDMENTS BETWEEN THE HOUSES Senate Action on House Amendments Senate bills returned with House amendments are held at the desk and almost always are subsequently laid before the Senate by the Presiding Officer on request or motion of a Senator (usually the Majority Leader or the manager of the bill). The Presiding Officer may (rarely) also do this voluntarily. After the House message has been laid down, the House’s amendments may be considered individually or, by unanimous consent, en bloc. Any one of the following motions relating to the amendment or amendments may then be offered, taking precedence in the order named: 1. 2. 3. 4.

A motion to refer the amendments to a standing committee of the Senate. A motion to amend the amendments. A motion to agree to the amendments. A motion to disagree to the amendments and ask a conference with the House.

Usually motion 4 includes authority for the Presiding Officer to appoint conferees on the part of the Senate, although the power to name conferees is in the Senate, not in the Chair. The number of conferees named varies widely. The usual range is 7–11, but occasionally a larger number is appointed, especially in the case of general appropriation bills or omnibus bills such as reconciliation measures. In the case of motion 2, the amendments made by the Senate to the House amendments are transmitted to the House, with a request for its concurrence therein. If the House concurs or agrees in all the amendments (the terms are used synonymously), the legislative steps in the passage of the bill are completed. The House, however, may amend the Senate amendments to the House amendments, as this is the second, and therefore the last, degree in which amendments between the Houses may be made. The House amendments, if any, are transmitted to the Senate, usually with a request for concurrence therein. As in the case of the original House amendments, the Senate may agree to some, disagree to others, or request a conference with the House thereon. A conference may be requested at any stage of the consideration of these amendments between the houses. If, instead, the Senate agrees to all the House amendments to the Senate bill or to the Senate’s amendments to House amendments, such action brings the two Houses into complete agreement, and likewise completes the legislative steps. If the Senate refers the House amendments to a standing committee, the committee, after consideration, may recommend action indicated in motions 2, 3, or 4, and may make such a motion accordingly on the Senate floor. Bills Originating in the House If a bill or resolution originates in the House, it follows the same steps as set forth above, except in reverse; a House committee considers it first, it is passed

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by the House, it is messaged to the Senate and referred to a Senate committee, the committee reports it to the Senate, and it is then acted on by that body. If amended, it is returned to the House for its concurrence in the Senate amendments.

CONFERENCE COMMITTEES AND REPORTS When the Senate requests a conference or agrees to the House’s request for a conference and names its conferees, it informs the House of its action by message. After the second House agrees to the conference, appoints conferees, and apprises the first House of its action by message, all the papers relating to the measure sent to conference (referred to as the ‘‘official papers’’) are transmitted to the conference. This includes the original engrossed bill, engrossed amendments, and the various messages of transmittal between the Houses. Since the conferees of each House vote as a unit, the House, like the Senate, may appoint as many conferees as it chooses to meet with the Senate conferees to reconcile the differences between the two Houses—which is the sole purpose of a conference. Thus, having a larger number of conferees than the other House does not provide an advantage. After deliberation, the conferees may make one or more recommendations; for example, that the (1) House recede from all or certain of its amendments, (2) the Senate recede from its disagreement to all or certain of the House amendments and agree to the same, or (3) the conference committee report an inability to agree in all or in part. Usually, however, there is compromise. Conferees dealing with an amendment or a series of amendments are more limited in their options than conferees dealing with a bill passed by the second House with an amendment in the nature of a substitute. They can deal only with the matters in disagreement. They cannot insert new matter or leave out matter agreed to by both Houses, and if they exceed their authority, a point of order will lie against the conference report. Each House may instruct its conferees, but this is rarely done. Such instructions are not binding since conferences are presumed to be full and free—one House cannot restrict the other House’s conferees. Where one House passes a bill of the other House with an amendment in the nature of a substitute and the measure then goes to conference, the conferees have wider latitude since the entire matter is in conference. They may report a third version on the same subject matter; all of its provisions, however, must be germane modifications of either the House or Senate version, or it will be subject to a point of order.

SENATE AND HOUSE ACTION ON CONFERENCE REPORTS The recommendations of the conferees are incorporated in a written report and a joint statement of managers, made in duplicate, both of which must be signed by a

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majority of the conferees of each House. If there are amendments on which they were unable to agree, a statement to this effect is included in the report. These are referred to as amendments in disagreement. The conferees cannot report parts of amendments in disagreement. For example, conferees must report in full agreement or disagreement when a bill had gone to conference after one House had amended it with a complete substitute for the other House’s text. One report, together with the papers if the House is to act on it first, is taken by the House conferees, or managers, as they are termed in that body, and subsequently presented by them to the House, with an accompanying explanatory statement as to the effect of this report on the matters involved. The report must lie over 3 days in the House before it may be considered, except during the last 6 days of a session. The Senate conferees take the other copy, which is presented for printing under the requirements of the Legislative Reorganization Act, as amended in 1970. To save time and expense, this requirement is frequently waived in the Senate by unanimous consent. Normally, the House agreeing to a conference on a bill acts first on conference report, but either House can act first if it has the official papers. Conference reports are privileged in both the Senate and the House. They cannot be amended, but must be voted on in their entirety. If amendments in disagreement were reported by the conferees, they are acted on after the conference report is adopted and may be subject to amendment. After adoption by the first House, the conference report is transmitted with the official papers to the other House with a message announcing its action. Assuming action by the House first, the Senate conferees could then present their report and ask for its immediate consideration. It does not have to lie over for 3 days in the Senate, as it does in the House, and the motion to proceed to its consideration is not debatable; thus the Senate may act immediately. A motion to recommit a conference report may not be made in the second House acting on the report since the conferees of the first House were discharged when their body agreed to the report. If conferees reach a complete agreement on all the House amendments to a Senate bill, and the House adopts that report, the adoption of the report by the Senate completes the legislative action on the bill. If, however, there were amendments on which an agreement had not been reached by the conferees, the adoption of the report by both Houses leaves the parliamentary status of these particular amendments in disagreement the same as if no conference had been held. If the amendments on which an agreement could not be reached were House amendments, and the House acted first on the report, it could then recede from its amendments, eliminating the amendments in disagreement; then, if the Senate were to adopt the report, the bill would be cleared for the President’s signature. If they were Senate amendments and the House acted first, the House could concur in the Senate amendments or concur in them with amendments. If the Senate amendments were concurred in by the House, that would clear the amendments in disagreement, and when the Senate agreed to the conference report, the bill would be cleared for the President’s signature. If the House should concur in the Senate amendments

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reported in disagreement with its own House amendments, after the Senate agreed to the report, it could concur in the House amendments to the Senate amendments, which would clear the bill for the President’s signature. If the amendments reported in disagreement are not so disposed of, a further conference on these amendments could be requested by one House and agreed to by the other. When this happens, the two Houses usually appoint the same conferees. Until all the amendments in disagreement are reconciled by the two Houses, the bill cannot be presented to the President. If a conference report is rejected by one of the Houses, it so notifies the other body by message and usually requests another conference; however, it may merely notify the second body of its action without requesting a further conference, leaving further steps to be taken by the other House. Endorsements showing these various legislative steps, and when taken, are made on the engrossed bill. When the two Houses reach a complete agreement on all the amendments, the papers are delivered to the Enrolling Clerk of the House where the bill originated. The Enrolling Clerk prepares a copy of the bill in the form as finally agreed on by the two Houses and sends it to the Government Printing Office for ‘‘enrollment,’’ which means historically ‘‘written on parchment.’’ The original papers on the bill are retained in the files of the originating House until the end of a Congress, when they are sent to the National Archives.

SIGNATURES OF SPEAKER AND VICE PRESIDENT On receipt of an enrolled bill from the Government Printing Office, either the Secretary of the Senate or the Clerk of the House endorses it, certifying where the bill originated. If, after examination by the Enrolling Clerk of that House, the bill is found to be in the form agreed on by both Houses, a slip is attached thereto stating that the bill, identified by number and title, has been examined and found truly enrolled. It is then presented to the Speaker of the House for signature, which is announced in open session. Usually, enrolled bills are signed first by the Speaker. The bill is then transmitted by messenger to the Senate, where it is signed by the Vice President. Under the rules of the House, the Committee on House Oversight is charged, when an enrolled bill has been duly signed by the Speaker and the Vice President, to present the same, when the bill has originated in the House, to the President of the United States for signature ‘‘and report the fact and date of such presentation to the House.’’ If it is a Senate bill, this responsibility of presenting the bill to the President falls on the Secretary of the Senate. An error discovered in a bill after the legislative steps in its passage have been completed may be corrected by authority of a concurrent resolution, provided the bill has not yet been approved by the President. If the bill has not been enrolled, the error may be corrected in the enrollment; if it has been enrolled and signed by the Presiding Officers of the two Houses, or by the Speaker, such action may be rescinded by a concurrent resolution agreed to by the two Houses, and the bill correctly reenrolled. If it has been presented to, but not acted

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on, by the President, the President may be requested by a concurrent resolution to return it to the Senate or the House for correction. If, however, the President has approved the bill, and it has thereby become a law, any amendment thereof can be made only by the passage of another bill, which must take the same course as the original.

PRESIDENTIAL ACTION—APPROVAL OR VETO The President, under the Constitution, has 10 days (Sundays excepted) after the bill has been presented to him in which to act on it. If the subject matter of the bill is within the jurisdiction of a department of the government, or affects its interests in any way, he may in the meantime, at the President’s discretion, refer the bill to the head of that department for investigation and a report thereon. The report of such official may serve as an aid to the President in reaching a decision about whether to approve the bill. If the President does approve it, he signs the bill, giving the date, and transmits this information by messenger to the Senate or the House, as the case might be. In the case of revenue and tariff bills, the hour of approval is usually indicated. The enrolled bill is delivered to the Archivist of the United States, who designates it as a public or private law, depending on its purpose, and gives it a number. Public and private laws are numbered separately and serially. An official copy is sent to Government Printing Office to be used in making the so-called slip law print. In the event the President does not desire to approve a bill, but is unwilling to veto it, he may, by not returning it within the 10-day period after it is presented to him, permit it to become a law without his approval. The Archivist makes an endorsement on the bill that, having been presented to the President of the United States for his approval and not having been returned to the House of Congress in which it originated within the time prescribed by the Constitution, it has become a law without his approval. Where the 10-day period extends beyond the date of the final adjournment of Congress, the President may, within that time approve and sign the bill, which thereby becomes a law. If, however, in such a case, the President does not approve and sign the bill before the expiration of the ten-day period, it fails to become a law. This is what is known as a ‘‘pocket veto’’. The United States Court of Appeals, in the case of KENNEDY v. SAMPSON, 511 F.2d 430 (D.C. Cir., 1974), held that a Senate bill could not be pocket-vetoed by the President during an ‘‘intrasession’’ adjournment of Congress to a day certain for more than 3 days, where the Secretary of the Senate had been authorized to receive Presidential messages during such adjournment. In the case of BARNES v. KLINE, 759 F.2d 51 (D.C. Cir., 1985), the Court held the same with regard to an intersession adjournment. If the President does not favor a bill and vetoes it, he returns it to the House of origin without his approval, together with his objections thereto (referred to as the ‘‘veto message’’). It should be noted that after the final adjournment of the 94th Congress, 1st session, the President returned two bills, giving Congress the

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opportunity to reconsider and ‘‘override’’ the vetoes. The constitutional provision for reconsideration by the Senate is met, under the precedents, by the reading of the veto message, spreading it on the Journal, and adopting a motion (1) to act on it immediately; (2) to refer it, with the accompanying papers, to a standing committee; (3) to order that it lie on the table, to be subsequently considered; or (4) to order its consideration postponed to a definite day. The House’s procedures are much the same. If, on reconsideration by either House, the House of origin acting first, the bill does not receive a two-thirds vote, the President’s veto is sustained and the bill fails to become a law. If a bill which has been vetoed is passed on reconsideration by the first House by the required two-thirds vote, an endorsement to this effect is made on the back of the bill, and it is then transmitted, together with the accompanying message, to the second House for its action thereon. If likewise reconsidered and passed by that body, a similar endorsement is made thereon. The bill, which has thereby been enacted into law, is not again presented to the President, but is delivered to the Administrator of the General Services Administration for deposit in the Archives, and is printed, together with the attestations of the Secretary of the Senate and the Clerk of the House of its passage over the President’s veto.

THE CONGRESSIONAL BUDGET PROCESS The Congressional Budget and Impoundment Control Act was enacted in 1974 as a means for Congress to establish national budget priorities and the appropriate level of total revenues, expenditures, and debt for each year. Moreover, it provided for strict time limits in dealing with Presidential attempts to impound funds already appropriated either through deferrals or rescissions. The Act has been amended so as to curb the practice of imposing unfunded federal mandates on states and local governments, as well as to give the President Line Item Veto authority with respect to appropriations, new direct spending, and limited tax benefits. There has also been added to the statutes a provision allowing the two Houses of Congress to vote in an expeditious manner to reject rules issued by executive agencies. Congress acts on a concurrent resolution on the budget in the spring of each year. This resolution sets levels of new budget authority and spending, revenue, and debt levels. However, Congress may adopt a later budget resolution that revises or reaffirms the most recently adopted budget resolution. One mechanism that Congress uses to enforce projected budget authority and spending, revenue, and debt levels is called the reconciliation process. Under reconciliation, Congress in a budget resolution directs one or more legislative committees to report bills or recommend changes in laws that will achieve the levels of spending and revenues set by the budget resolution. The directions to the committees specify the total amounts that must be changed but leave to the discretion of the committees decisions about the changes that must be made to achieve the required levels.

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If only one committee has been directed to recommend changes, that committee reports its reconciliation legislation directly to the floor for consideration. If, however, more than one committee has been directed to make changes, the committee reports the recommended changes to the Committee on the Budget. That committee then reports an omnibus reconciliation bill to the floor for consideration by the whole Senate or House.

EXECUTIVE BUSINESS AND EXECUTIVE SESSIONS Executive Matters Generally The executive business of the Senate consists of nominations and treaties submitted to the Senate by the President of the United States for its ‘‘advice and consent.’’ This business of the Senate is handled separately from its legislative business. Treaties are referred to the Committee on Foreign Relations. Nominations are referred to one of the various committees of the Senate; usually this is the committee that handled the legislation creating the position. When committees report treaties or nominations to the Senate, they are placed on the Executive Calendar, as distinct from the Calendar of Business, on which legislation is placed. These two calendars are printed separately. When the Senate considers nominations and treaties, it goes into executive session, as distinct from legislative session, and a separate Journal is kept of the proceedings thereon. Nominations The scope of the Senate’s authority to confirm Presidential nominations is vast. It includes officers of the government—specifically, ambassadors, other public ministers and counsels, justices of the Supreme Court, all other officers of the United States as set forth in the Constitution, and such officers as Congress by law may designate. A Presidential nomination requiring advice and consent must be approved by a majority vote of the Senate. After a nomination is received and referred to the appropriate committee, hearings may be held, and after the committee votes, the nomination may be reported back to the Senate. If the nomination is confirmed, a Resolution of Confirmation is transmitted to the White House and the appointment is then signed by the President. Presidential nominations may be made during recesses of the Senate. The Constitution authorizes the President to ‘‘fill up’’ vacancies that may occur during such recesses ‘‘by granting Commissions which shall expire at the End of their next Session.’’ Recess appointments to the Supreme Court, however, troubled the Senate to such an extent that it agreed to a sense of the Senate resolution on August 29, 1960, stating that such appointments ‘‘may not be wholly consistent with the best interests of the Supreme Court, the nominee who may be involved, the litigants before the Court, nor indeed the people of the United States.’’ It further

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stated ‘‘that such appointments, therefore, should not be made except under unusual circumstances and for the purpose of preventing or ending a demonstrable breakdown in the administration of the Court’s business.’’ Treaties All confidential communications made by the President shall be kept secret, and all treaties that may be laid before the Senate, and all remarks, votes, and proceedings thereon, shall also be kept secret until the Senate shall, by their resolution, remove the injunction of secrecy. When the Senate is proceeding on treaty ratification, the treaty shall be read a first time. Only a motion to refer it to committee, to print it in confidence for the use of the Senate, or to remove the injunction of secrecy shall be in order. The rules for the consideration for executive business are different from the rules for the consideration and disposition of legislative business. Rule XXX provides that a treaty shall lie over for one day before the Senate proceeds to consider it in executive session; then it may be read a second time, after which amendments may be proposed. At any stage of these proceedings the Senate may remove the injunction of secrecy from the treaty. When there is no further debate or amendment to be proposed to the treaty, the Senate proceeds to consider a resolution of ratification. After the resolution of ratification has been proposed, no amendment to the treaty is in order except by unanimous consent. On the other hand, reservations and other matters are in order only during consideration of the resolution of ratification, not while the treaty itself is being considered for amendment. After the Senate completes considering both the treaty and the resolution of ratification, it gives its final consent to the resolution by a two-thirds vote of the Senators present. The vote on a motion to postpone indefinitely requires the same two-thirds majority; all other motions and questions arising in relation to a treaty are decided by a majority vote. Amendments, Reservations, and Other Statements The Senate may stipulate conditions to a treaty in the form of amendments, reservations, understandings, declarations, statements, interpretations, and statements in committee reports. An ‘‘amendment’’ makes actual changes in the language of the treaty. The term ‘‘reservation’’ in treatymaking, according to general international usage, means a formal declaration by a state, when signing, ratifying, of adhering to a treaty, that modifies or limits the substantive effect of one or more of the treaty’s provisions as between the reserving state and other states party to the treaty. In addition, the Senate may attach to resolutions of ratification various ‘‘understandings,’’ ‘‘interpretations,’’ ‘‘declarations,’’ and so on. The term ‘‘understanding’’ is often used to designate a statement that is not intended to modify or limit any of the provisions of the treaty in its international operation, but instead is intended merely

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to clarify or explain the meaning of the treaty or to deal with some matter incidental to the operation of the treaty without constituting a substantive reservation. Any such additions to the resolution are part of the instrument of ratification no matter what they are called, and even if their effect is solely of an internal domestic nature. Ratification of Treaties The word ‘‘ratification,’’ when used in connection with ‘‘treaties,’’ refers to the formal act by which a nation affirms its willingness to be bound by a specific international agreement. The basic purpose of ratification of a treaty is to confirm that an agreement that two or more countries have negotiated and signed is accepted and recognized as binding by those countries. The procedure by which nations ratify treaties is a concern of domestic rather than international law. The Constitution does not use the term ‘‘ratification’’ in regard to treaties. It says only that the President shall have the power, by and with the advice and consent of the Senate, to make treaties. The Constitution does not divide up the process into various component parts that can be identified today, such as initiation, negotiation, signing, Senatorial advice and consent, ratification, deposit or exchange of the instruments of ratification, and promulgation. From the beginning, however, the formal act of ratification has been performed by the President acting ‘‘by and with the advice and consent of the Senate.’’ The President ratifies the treaty, but only on authorization of the Senate. The Senate gives its advice and consent by agreeing to the resolution of ratification. After it does so, the President is not obligated to proceed with the process of ratification. With the President’s approval, however, the ratification occurs with the exchange of the instruments of ratification between the parties to the treaty. Treaties, unlike any other business considered by the Senate, stay before that body once the President submits them until the Senate acts on them or unless the President requests, and=or the Senate adopts an order or resolution authorizing, their return to the President or the Secretary of State. In 1937, 1947, and 1952, the Senate returned numerous treaties, including some dating back as early as 1910, to the Secretary of State or the President.

Appendix G LISTING OF DRINKING WATER FEDERAL REGISTER NOTICES COMPILED BY FREDERICK W. PONTIUS, P.E. Pontius Water Consultants, Inc. Lakewood, Colorado

2003 Integrated Risk Information System (IRIS); Announcement of 2003 Program; Request for Information and Announcement of Workshop. Fed. Reg., 68(24):5870–5873 (February 5, 2003). Office of Management and Budget. Draft 2003 Report to Congress on the Costs and Benefits of Federal Regulations. Notice and request for comments. Fed. Reg., 68(22):5492–5527 (February 3, 2003).

2002 Endocrine Disruptor Screening Program, Proposed Chemical Selection Approach for Initial Round of Screening; Request for Comment. Notice. Fed. Reg., 67(250):79611–79629 (December 30, 2002). Minor Clarification of National Primary Drinking Water Regulation for Arsenic. Proposed rule. Fed. Reg., 67(246):78203–78209 (December 23, 2002). Notice of Data Availability; National Primary and Secondary Drinking Water Regulations: Approval of Analytical Methods for Chemical and Microbiological Contaminants; Additional Information on the Colitag Method. Proposed rule; notice of data availability. Fed. Reg., 67(231):71520–71523 (December 2, 2002). Drinking Water Regulation and Health, Edited by Frederick W. Pontius. ISBN 0-471-41554-5 # 2003 John Wiley & Sons, Inc.

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LISTING OF DRINKING WATER FEDERAL REGISTER NOTICES

National Primary Drinking Water Regulations: Minor Revisions to Public Notification Rule, Consumer Confidence Report Rule and Primacy Rule. Final rule. Fed. Reg., 67(229):70850–70858 (November 27, 2002). Guidelines Establishing Test Procedures for the Analysis of Pollutants; Whole Effluent Toxicity Test Methods; Final Rule. Final rule. Fed. Reg., 67(223):69952–69972 (November 19, 2002). Unregulated Contaminant Monitoring Regulation: Approval of Analytical Method for Aeromonas; National Primary and Secondary Drinking Water Regulations: Approval of Analytical Methods for Chemical and Microbiological Contaminants. Final rule. Fed. Reg., 67(209):65888–65902 (October 29, 2002). Guidelines Establishing Test Procedures for the Analysis of Pollutants; Measurement of Mercury in Water; Revisions to EPA Method 1631. Final rule. Fed. Reg., 67(209):65876–65888 (October 29, 2002). Guidelines Establishing Test Procedures for the Analysis of Pollutants Under the Clean Water Act; National Primary Drinking Water Regulations; and National Secondary Drinking Water Regulations; Methods Update. Final rule. Fed. Reg., 67(205):65220–65253 (October 23, 2002). Underground Injection Control (UIC) Program; Hydraulic Fracturing of Coal bed Methane (CBM) Wells Report—Notice. Notice of availability of draft report and request for comment. Fed. Reg., 67(167):55249–55251 (August 28, 2002). Joint USEPA=State Environmental Council of the States (ECOS) Agreement to Pursue Regulatory Innovation: Alternative Treatment Technique for National Primary Drinking Water Lead and Copper Regulations for Certain Non-transient Non-community Water Systems. Notice of Availability of draft Variance for Public Review and Comment. Fed. Reg., 67(151):50880 (August 6, 2002). Announcement of Preliminary Regulatory Determinations for Priority Contaminants on the Drinking Water Contaminant Candidate List. Proposed Rule Correction. Fed. Reg. 67(137):46949 (July 17, 2002). Announcement of a Stakeholder Meeting on Preliminary Regulatory Determinations for Priority Contaminants on the Drinking Water Contaminant Candidate List. Notice of a Stakeholder Meeting. Fed. Reg. 67(118):41722 (June 19, 2002). Underground Injection Control Program. Notice of Final Determination for Class V Wells. Final Rule. Fed. Reg. 67(110):39584–39593 (June 7, 2002). Announcement of Preliminary Regulatory Determinations for Priority Contaminants on the Drinking Water Contaminant Candidate List. Notice of Preliminary Regulatory Determination. Fed. Reg. 67(106):38222–38244 (June 2, 2002). National Primary Drinking Water Regulations; Announcement of the Results of EPA’s Review of Existing Drinking Water Standards and Request for Public Comment; Proposed Rule. Fed. Reg. 67(74):19030–19047 (April 17, 2002). Unregulated Contaminant Monitoring Regulation; Approval of Analytical Method for Aeromonas; National Primary and Secondary Drinking Water Regulations; Approval of Analytical Methods for Chemical and Microbiological Contaminants; Proposed Rule. Fed. Reg. 67(45):10532–10549 (March 7, 2002). Laboratory Quality Assurance Evaluation Program for Analysis of Cryptosporidium Under the Safe Drinking Water Act; Agency Information Collection; Proposed Collection; Comment Request. Fed. Reg. 67(42):9731–9734 (March 4, 2002).

LISTING OF DRINKING WATER FEDERAL REGISTER NOTICES

955

Flexible State Enforcement Responses to Small Community Violations, EPA Policy and Guidance. Policy Statement and Request for Public Comment on Possible Revisions. Fed. Reg. 67(5):3185–3192 (Jan. 23, 2002). National Primary Drinking Water Regulations; LT1ESWTR. Final Rule. Fed. Reg. 67(9):1812– 1844 (Jan. 14, 2002).

2001 National Primary Drinking Water Regulations; Arsenic and Clarifications to Compliance and New Source Contaminants Monitoring. Notice of Data Availability. Fed. Reg. 66(194):50961–50963 (Oct. 5, 2001). National Primary Drinking Water Regulations: Minor Revisions to Public Notification Rule and Consumer Confidence Report Rule; Proposed Rule. Fed. Reg. 66(174):46928–46935 (Sept. 7, 2001). Guidelines Establishing test Procedures for the Analysis of Pollutants; Analytical Methods for Biological Pollutants in Ambient Water; Proposed Rule. Fed. Reg. 66(169):45811–45829 (Aug. 30, 2001). National Primary Drinking Water Regulations; Arsenic and Clarifications to Compliance and New Source Contaminants Monitoring. Proposed Rule; Correction. Fed. Reg. 66(159):42974–42975 (Aug. 16, 2001). National Primary Drinking Water Regulations; Arsenic and Clarifications to Compliance and New Source Contaminants Monitoring. Notice of Proposed Rulemaking. Fed. Reg. 66(139):37617–37631 (July 19, 2001). Beverages; Bottled Water; Technical Amendment; Confirmation of Effective Date. Fed. Reg. 66(129):35373 (July 5, 2001). Beverages; Bottled Water. Fed. Reg. 66(129):35439–35441 (July 5, 2001). National Primary Drinking Water; Filter Backwash Recycling Rule; Final Rule. Fed. Reg. 66(111):31086–31105 (June 8, 2001). National Primary Drinking Water Regulations; Arsenic and Clarifications to Compliance and New Source Contaminants Monitoring. Delay of Effective Date; Final Rule. Fed. Reg. 66(99):28342–28350 (May 22, 2001). Allocation of Drinking Water State Revolving Fund Monies. Fed. Reg. 66(97):27648–27651 (May 18, 2001). Unregulated Contaminant Monitoring Regulation for Public Water Systems; Analytical Methods of List 2 Contaminants; Clarifications to the Unregulated Contaminant Monitoring Regulation. Fed. Reg. 66(95):27215–27216 (May 16, 2001). Withdrawal of Direct Final Rule; Guidelines Establishing Test Procedures for the Analysis of Pollutants under the Clean Water Act; National Primary Drinking Water Regulations and National Secondary Drinking Water Regulations; Methods Update. Fed. Reg. 66(94):26795 (May 15, 2001). Rural Utilities Service; Water and Waste Disposal Programs Guaranteed Loans. Fed. Reg. 66(89):23135–23151 (May 8, 2001). National Primary Drinking Water Regulations; Arsenic and Clarifications to Compliance and New Source Contaminants Monitoring. Proposed Rule. Fed. Reg. 66(78):20580–20584 (April 23, 2001).

956

LISTING OF DRINKING WATER FEDERAL REGISTER NOTICES

Final Additions to the Final Guidelines for the Certification and Recertification of the Operators of Community and Nontransient Noncommunity Public Water Systems; Final Allocation Methodology for Funding to States for the Operator Certification Expense Reimbursement Grants Program; Final Notice. Fed. Reg. 66(75):19939–19952 (April 18, 2001). National Primary Drinking Water Regulations; Arsenic and Clarifications to Compliance and New Source Contaminants Monitoring. Delay of Effective Date; Final Rule. Fed. Reg. 66(57):16134–16135 (March 23, 2001). Revisions to the Interim Enhanced Surface Water Treatment Rule (IESWTR), the Stage 1 Disinfectants and Disinfection Byproducts Rule (Stage 1 DBPR), and Revisions to State Primacy Requirements to Implement the Safe Drinking Water Act (SDWA) Amendments. Fed. Reg. 66(29):9903 (Feb. 12, 2001). National Primary Drinking Water Regulations; Arsenic and Clarifications to Compliance and New Source Contaminants Monitoring; Final Rule. Fed. Reg. 66(14):6976–7066 (Jan. 22, 2001). Revisions to the Interim Enhanced Surface Water Treatment Rule (IESWTR), the Stage 1 Disinfectants and Disinfection Byproducts Rule (Stage 1 DBPR), and Revisions to State Primacy Requirements to Implement the Safe Drinking Water Act (SDWA) Amendments; Final Rule. Fed. Reg. 66(10):3770–3780 (Jan. 16, 2001). Guidelines Establishing Test Procedures for the Analysis of Pollutants under the Clean Water Act; National Primary Drinking Water Regulations; and National Secondary Drinking Water Regulations; Methods Update; Direct Final Rule. Fed. Reg. 66(10):3466–3497 (Jan. 16, 2001). Drinking Water State Revolving Funds Rule. Adoption of Interim Final Rule as Final Rule. Fed. Reg. 66(9):2823–2825 (Jan. 12, 2001). Unregulated Contaminant Monitoring Regulation for Public Water Systems; Analytical Methods for List 2 Contaminants; Clarifications to the Unregulated Contaminant Monitoring Regulation; Final Rule. Fed. Reg. 66(8):2273–2308 (Jan. 11, 2001).

2000 Stage 2 Microbial and Disinfection Byproducts Federal Advisory Committee Agreement in Principle. Fed. Reg. 65(251):83015–83024 (Dec. 29, 2000). Draft Public Involvement Policy. Proposed Policy. Fed. Reg. 65(250):82335–82345 (Dec. 28, 2000). National Primary Drinking Water Regulations; Radionuclides; Final Rule. Fed. Reg. 65(236):76708–76753 (Dec. 7, 2000). National Primary Drinking Water Regulations; Arsenic and Clarifications to Compliance and New Source Contaminants Monitoring. Notice of Data Availability. Fed. Reg. 65(204):63027–63035 (Oct. 20, 2000). Unregulated Contaminant Monitoring Regulation for Public Water Systems; Analytical Methods for List 2 Contaminants and Clarifications; Proposed Rule. Fed. Reg. 65(178):55362–55398 (Sept. 13, 2000). Drinking Water State Revolving Funds; Interim Final Rule. Fed. Reg. 65(152):48286–48312 (Aug. 7, 2000). Proposed Additions to the Final Guidelines for the Certification and Recertification of the Operators of Community and Nontransient Noncommunity Public Water Systems;

LISTING OF DRINKING WATER FEDERAL REGISTER NOTICES

957

Proposed Allocation Methodology for Funding to States for the Operator Certification Expense Reimbursement Grants Program. Notice. Fed. Reg. 65(140):45057–45063 (July 20, 2000). National Primary Drinking Water Regulations; Arsenic and Clarifications to Compliance and New Source Contaminants Monitoring. Proposed Rule. Fed. Reg. 65(121):38888–38983 (June 22, 2000). National Primary Drinking Water Regulations; Ground Water Rule. Notice of Extension of Public Comment Period for the Proposed Ground Water Rule. Fed. Reg. 65(115):37331– 37332 (June 14, 2000). Reopening of the Comment Period on Revisions to the Interim Enhanced Surface Water Treatment Rule (IESWTR), the Stage 1 Disinfectants and Disinfection Byproducts Rule (Stage 1 DBPR) and Revisions to State Primacy Requirements to Implement the Safe Drinking Water Act (SDWA) Amendments. Fed. Reg. 65(114):37092 (June 13, 2000). Revisions to the Interim Enhanced Surface Water Treatment Rule (IESWTR), the Stage 1 Disinfectants and Disinfection Byproducts Rule (Stage 1 DBPR) and Revisions to State Primacy Requirements to Implement the Safe Drinking Water Act (SDWA) Amendments; Direct Final Rule Withdrawal. Fed. Reg. 65(114):37052–37053 (June 13, 2000). Removal of the Maximum Contaminant Level Goal for Chloroform from the National Primary Drinking Water Regulations. Fed. Reg. 65(104):34404–34405 (May 30, 2000). National Primary Drinking Water Regulations; Ground Water Rule; Proposed Rules. Fed. Reg. 65(91):30194–30274 (May 10, 2000). National Primary Drinking Water Regulations; Public Notification Rule; Final Rule. Fed. Reg. 65(87):25982–26049 (May 4, 2000). National Primary Drinking Water Regulations; Radionuclides; Notice of Data Availability; Proposed Rule. Fed. Reg. 65(78):21576–20313 (April 21, 2000). Revisions to the Interim Enhanced Surface Water Treatment Rule (IESWTR), the Stage 1 Disinfectants and Disinfection Byproducts Rule (Stage 1 DBPR) and Revisions to State Primacy Requirements to Implement the Safe Drinking Water Act (SDWA) Amendments; Final Rule and Proposed Rule. Fed. Reg. 65(73):20304–20313 (April 14, 2000). Revisions to the Interim Enhanced Surface Water Treatment Rule (IESWTR), the Stage 1 Disinfectants and Disinfection Byproducts Rule (Stage 1 DBPR) and Revisions to State Primacy Requirements to Implement the Safe Drinking Water Act (SDWA) Amendments; Proposed Rule. Fed. Reg. 65(73):20314 (April 14, 2000). National Primary Drinking Water Regulations: Long Term 1 Enhanced Surface Water Treatment and Filter Backwash Rule. Proposed Rule. Fed. Reg. 65(69):19046–19150 (April 10, 2000). Methyl Tertiary Butyl Ether (MTBE) Advance Notice of Intent to Initiate Rulemaking Under the Toxic Substances Control Act to Eliminate or Limit the Use of MTBE as a Fuel Additive in Gasoline; Advance Notice of Proposed Rulemaking. Fed. Reg. 65(58):16094–16109 (March 24, 2000). Unregulated Contaminant Monitoring Regulation for Public Water Systems; Analytical Methods for Perchlorate and Acetochlor; Announcement of Laboratory Approval and Performance Testing (PT) Program for the Analysis of Perchlorate. Direct Final Rule. Fed. Reg. 42(65):11372–11385 (March 2, 2000). Unregulated Contaminant Monitoring Regulation for Public Water Systems; Analytical Methods for Perchlorate and Acetochlor; Announcement of Laboratory Approval and

958

LISTING OF DRINKING WATER FEDERAL REGISTER NOTICES

Performance Testing (PT) Program for the Analysis of Perchlorate; Final Rule and Proposed Rule. Fed. Reg. 65(42):11372–11385 (March 2, 2000). Unregulated Contaminant Monitoring Regulation for Public Water Systems; Analytical Methods for Perchlorate and Acetochlor; Announcement of Laboratory Approval and Performance Testing (PT) Program for the Analysis of Perchlorate; Proposed Rule. Fed. Reg. 65(42):11386 (March 2, 2000). Food and Drug Administration Draft Study Report; Feasibility of Appropriate Methods of Informing Customers of the Contents of Bottled Water. Notice. Fed. Reg. 65(35):8717– 8722 (Feb. 22, 2000). National Primary Drinking Water Regulations for Lead and Copper; Final Rule. Fed. Reg. 65(8):1950–2015 (Jan. 12, 2000).

1999 National Primary Drinking Water Regulations; Radon-222. Proposed Radon in Drinking Water Rule; Notice of Extension of Public Comment Period. Fed. Reg. 64(244):71367–71368 (Dec. 21, 1999). Revisions to the Underground Injection Control Regulations for Class V Injection Wells. Correction. Fed. Reg. 64(241):70316 (Dec. 16, 1999). Underground Injection Control Regulations for Class V Injection Wells, Revision; Final Rule. Fed. Reg. 64(234):68546–68573 (Dec. 7, 1999). National Primary and Secondary Drinking Water Regulations; Analytical Methods for Chemical and Microbiological Contaminants and Revisions to Laboratory Certification Requirements; Final Rule. Fed. Reg. 64(230):67450–67467 (Dec. 1, 1999). National Primary Drinking Water Regulations; Radon-222; Proposed Rule. Fed. Reg. 64(211):59246–59378 (Nov. 2, 1999). Revisions to the Unregulated Contaminant Monitoring Regulation for Public Water Systems; Final Rule. Fed. Reg. 64(180):50556–50620 (Sept. 17, 1999). National Primary Drinking Water Regulation; Consumer Confidence Reports; Correction. Fed. Reg. 64(124):34732–34733 (June 29, 1999). Guidelines Establishing Test Procedures for the Analysis of Pollutants; Measurement of Mercury in Water (EPA Method 1631, Revision B); Final Rule. Fed. Reg. 64(109):30417–30434 (June 8, 1999). Revisions to the Unregulated Contaminant Monitoring Regulation for Public Water Systems; Correction. Fed. Reg. 64(109):3464–30465 (June 8, 1999). National Primary Drinking Water Regulations; Public Notification Rule; Proposed Rule. Public Notification Handbook; Draft for Comment; Notice. Fed. Reg. 64(92):25964–26001 (May 13, 1999). Revisions to the Unregulated Contaminant Monitoring Regulation for Public Water Systems; Proposed Rule. Fed. Reg. 64(83):23398–23458 (April 30, 1999). Microbial Disinfectants=Disinfection Byproducts Advisory Committee; Notice of Charter Renewal. Fed. Reg. 64(53):13574–13575 (March 19, 1999). Radon in Drinking Water Health Risk Reduction and Cost Analysis; Notice. Fed. Reg. 64(38):9560–9599 (Feb. 26, 1999).

LISTING OF DRINKING WATER FEDERAL REGISTER NOTICES

959

Health Effects from Exposure to High Levels of Sulfate in Drinking Water Study and Sulfate Workshop; Notice. Fed. Reg. 64(28):7028–7030 (Feb. 11, 1999). Final Guidelines for the Certification and Recertification of the Operators of Community and Nontransient Noncommunity Public Water Systems; Notice. Fed. Reg. 64(24):5916–5921 (Feb. 5, 1999). National Primary Drinking Water Regulations; Analytical Methods for Microbes, Lead, and Magnesium; Proposed Rule. Fed. Reg. 64(9):2538–2544 (Jan. 14, 1999). Drinking Water State Revolving Fund (DWSRF) Program Policy Announcement: Eligibility of Reimbursement of Incurred Costs for Approved Projects. Fed. Reg. 64(7):1802–1804 (Jan. 12, 1999). Suspension of Unregulated Contaminant Monitoring Requirements for Small Public Water Systems; Final Rule and Proposed Rule. Fed. Reg. 64(5):1493–1498 (Jan. 8, 1999).

1998 Withdrawal of the National Primary Drinking Water Regulations; Analytical Methods for Regulated Drinking Water Contaminants; Direct Final Rule. Fed. Reg. 63(251):72200 (Dec. 31, 1998). National Primary Drinking Water Regulations; Disinfectants and Disinfection Byproducts; Final Rule. Fed. Reg. 63(241):69390–69476 (Dec. 16, 1998). National Primary Drinking Water Regulations; Interim Enhanced Surface Water Treatment Rule; Final Rule. Fed. Reg. 63(241):69478–69521 (Dec. 16, 1998). Final Guidelines for Implementation of the Drinking Water State Revolving Fund Program; Notice. Fed. Reg. 63(214):59844–59868 (Nov. 5, 1998). Drinking Water State Revolving Fund (DWSRF) Program Policy Announcement; Eligibility of Using DWSRF Funds to Create a New Public Water System. Notice. Fed. Reg. 63(212):59299–59300 (Nov. 3, 1998). Final Guidelines for Implementation of the Drinking Water Infrastructure Grants Tribal Set-Aside Program. Fed. Reg. 63(209):58047 (Oct. 29, 1998). Notice of Public Meeting: Workshop on Sulfate in Drinking Water. Fed. Reg. 63(175):48503 (Sept. 10, 1998). Safe Drinking Water Public Water System Program; Citizen Collection Action; Notice of Complaint Seeking Review of Penalty Order. Proposed Rule. Fed. Reg. 63(173):48078– 48080 (Sept. 8, 1998). Public Water System Program; Removal of Obsolete Rule and Safe Drinking Water Public Water System Program; Citizen Collection Action; Notice of Complaint Seeking Review of Penalty Order; Rule and Proposed Rule. Fed. Reg. 63(173):48075–48077 (Sept. 8, 1998). National Primary Drinking Water Regulations: Analytical Methods for Regulated Drinking Water Contaminants; Proposed Rule. Fed. Reg. 63(171):47115–47116 (Sept. 3, 1998). National Primary and Secondary Drinking Water Regulations: Analytical Methods for Regulated Drinking Water Contaminants; Final Rule. Fed. Reg. 63(171):47097–47114 (Sept. 3, 1998). Underground Injection Control Program: Substantial Modification to an Existing StateAdministered Underground Injection Control Program; Request for Public Comment on

960

LISTING OF DRINKING WATER FEDERAL REGISTER NOTICES

a Substantial Modification to the Wyoming 1422 Underground Injection Control Program. Fed. Reg. 63(166):45810–45812 (Aug. 27, 1998). National Primary Drinking Water Regulation: Consumer Confidence Reports; Final Rule. Fed. Reg. 63(160):44511–44536 (Aug. 19, 1998). Revision of Existing Variance and Exemption Regulations to Comply with Requirements of the Safe Drinking Water Act; Final Rule. Fed. Reg. 63(157):43833–43851 (Aug. 14, 1998). Waterborne Disease Studies and National Estimate of Waterborne Disease Occurrence; Notice. Fed. Reg. 63(154):42849–42852 (Aug. 11, 1998). Notice of Availability of Final Guidance on Implementing the Capacity Development Provisions of the Safe Drinking Water Act Amendments of 1996, and Information for States on Implementing the Capacity Development Provisions of the Safe Drinking Water Act Amendments of 1996; Notice. Fed. Reg. 63(153):42632–42633 (Aug. 10, 1998). Availability of Water Conservation Plan Guidelines; Notice. Fed. Reg. 63(151):42193–42195 (Aug. 6, 1998). Announcement of Small System Compliance Technology Lists for Existing National Primary Drinking Water Regulations and Findings Concerning Variance Technologies; Notice. Fed. Reg. 63(151):42032–42048 (Aug. 6, 1998). SDWA Section 1401(4) Public Water System Definition, as Amended by 1996 SDWA Amendments; Notice. Fed. Reg. 63(150):41939–41946 (Aug. 5, 1998). National Primary Drinking Water Regulations: Analytical Methods for Certain Pesticides and Microbial Contaminants; Proposed Rule. Fed. Reg. 63(147):41133–41143 (July 31, 1998). Review of Monitoring Requirements for Chemical Contaminants in Drinking Water. Fed. Reg. 63(146):40709 (July 30, 1998). Sole Source Aquifer Determination for the Cloverly Aquifer (Dakota and Lakota Sands) Elk Mountain, Wyoming. Fed. Reg. 63(135):38167–38169 (July 15, 1998). Notice of Lodging of Consent Decree Pursuant to the Safe Drinking Water Act. Fed. Reg. 63(117):33396 (June 18, 1998). Research Strategy for Oxygenates in Water. Fed. Reg. 63(113):32212–32213 (June 12, 1998). Proposed Policies Affecting the Drinking Water State Revolving Fund (DWSRF) Program and Announcement of Stakeholder Meeting. Fed. Reg. 63(113):32208–32209 (June 12, 1998). Removal of the Prohibition on the Use of Point-of-Use Devices for Compliance with National Primary Drinking Water Regulations. Fed. Reg. 63(112):31932–31934 (June 11, 1998). Notice of Lodging of Consent Decree under the Safe Drinking Water Act. Fed. Reg. 63(110):31525–31526 (June 9, 1998). National Primary Drinking Water Regulations: Consumer Confidence Reports. Fed. Reg. 63(94):27020–27021 (May 15, 1998). Beverages: Bottled Water; Companion Document to Direct Final Rule. Fed. Reg. 63(90):25789–25794 (May 11, 1998). Beverages: Bottled Water. Fed. Reg. 63(90):25764–25769 (May 11, 1998). Definition of a Public Water System in SDWA Section 1401(4) as Amended by the 1996 SDWA Amendment; Notice. Fed. Reg. 63(89):25739–25746 (May 8, 1998). National Primary Drinking Water Regulations: Disinfectants and Disinfection By-products; Notice of Data Availability: Notice of Reopening of Comment Period and Public Meeting. Fed. Reg. 63(89):25430 (May 8, 1998).

LISTING OF DRINKING WATER FEDERAL REGISTER NOTICES

961

Revisions to State Primacy Requirements to Implement Safe Drinking Water Act Amendments; Final Rule. Fed. Reg. 63(81):23361–23368 (April 28, 1998). Maximum Contaminant Level Goals and National Primary Drinking Water Regulations for Lead and Copper. Proposed Rule. Fed. Reg. 63(77):20037–20047 (April 22, 1998). Availability of Draft Water Conservation Plan Guidelines. Notice. Fed. Reg. 63(76):19724– 19725 (April 21, 1998). Revision of Existing Variance and Exemption Regulations to Comply with Requirements of the Safe Drinking Water Act. Proposed Rule. Fed. Reg. 63(75):19438–19457 (April 20, 1998). Health Risks from Low-Level Environmental Exposure to Radionuclides—Federal Guidance Report No. 13—Part 1; Interim Version. Fed. Reg. 63(70):18008–18009 (April 13, 1998). Rural Utilities Service Water and Waste Program Regulations. Final Rule. Fed. Reg. 63(63):16088–16089 (April 2, 1998). National Primary Drinking Water Regulations: Disinfectants and Disinfection Byproducts Notice of Data Availability; Proposed Rule. Fed. Reg. 63(61):15673–15692 (March 31, 1998). Public Review Draft Guidelines for the Certification and Recertification of the Operators of Community and Nontransient Noncommunity Public Water Systems. Fed. Reg. 63(59):15063–15068 (March 27, 1998). Announcement of the Drinking Water Contaminant Candidate List; Notice. Fed. Reg. 63(40):10273–10287 (March 2, 1998). Consolidated Rules of Practice Governing the Administrative Assessment of Civil Penalties, Issuance of Compliance or Corrective Action Orders, and the Revocation, Termination or Suspension of Permits. Proposed Rule. Fed. Reg. 63(37):9464–9494 (Feb. 25, 1998). National Primary Drinking Water Regulations: Consumer Confidence; Proposed Rule. Fed. Reg. 63(30):7606–7633 (Feb. 13, 1998). EPA’s National Drinking Water Contaminant Occurrence Data Base. Fed. Reg. 63(40):10274– 10287 (Jan. 26, 1998). Marine Sanitation Device Standard-Establishment of Drinking Water Intake No Discharge Zone(s) Fed. Reg. 63(5):1318–1320 (Jan. 8, 1998). EPA’s National Drinking Water Contaminant Occurrence Data Base. Fed. Reg. 63(2):225–226 (Jan. 5, 1998).

1997 Sole Source Aquifer Designation of the Guemes Island Aquifer System; Skagit County, Wash. Fed. Reg. 62(230):63545–63548 (Dec. 1, 1997). RUS Environmental Policies and Procedures. Proposed Rule. Fed. Reg. 62(226):62527–62538 (Nov. 24, 1997). Availability of Draft Document on Information for States on Developing Affordability Criteria for Drinking Water. Fed. Reg. 62(225):62308 (Nov. 21, 1997). Bottled Water Study: Feasibility of Appropriate Methods of Informing Customers of the Contents of Bottled Water; Request for Comments. Fed. Reg. 62(218):60721–60723 (Nov. 12, 1997). National Primary Drinking Water Regulations: Interim Enhanced Surface Water Treatment Rule Notice of Data Availability; Proposed Rule. Fed. Reg. 62(212):59485–59557 (Nov. 3, 1997).

962

LISTING OF DRINKING WATER FEDERAL REGISTER NOTICES

National Primary Drinking Water Regulations: Disinfectants and Disinfection Byproducts; Notice of Data Availability; Proposed Rule. Fed. Reg. 62(212):59387–59484 (Nov. 3, 1997). EPA’s National Drinking Water Contaminant Occurrence Data Base. Fed. Reg. 62(209):56164– 56165 (Oct. 29, 1997). Performance Based Measurement System. Fed. Reg. 62(193):52098–52100 (Oct. 6, 1997). Announcement of the Draft Drinking Water Contaminant Candidate List. Fed. Reg. 62(193):52193–52219 (Oct. 6, 1997). Review and Evaluation of USEPA Standards Regarding Children’s Health Protection from Environmental Risks. Fed. Reg. 62(192):51854–51855 (Oct. 3, 1997). RUS Refinancing Water and Wastewater Loans. Fed. Reg. 62(155):43142 (Aug. 12, 1997). Four Documents Required under the Safe Drinking Water Act as Amended. Fed. Reg. 62(154):42986–42993 (Aug. 11, 1997). Microbial and Disinfectants=Disinfection By-products Advisory Committee; Notice of Open Meeting. Fed. Reg. 62(124):34750 (June 27, 1997). Guidelines Establishing Test Procedures for the Analysis of Pollutants and National Primary Drinking Water Regulations; Flexibility in Existing Test Procedures and Streamlined Proposal of New Test Procedures; Correction, Announcement of Meetings, and Extension of Comment; Proposed Rule. Fed. Reg. 62(123):34573–34599 (June 26, 1997). Streamlining the Rural Utilities Service Water and Waste Program Regulations; Final Rule. Fed. Reg. 62(118):33461–33511 (June 19, 1997). Performance Evaluation Studies Supporting Administration of the Clean Water Act and Safe Drinking Water Act. Fed. Reg. 62(113):32112–32113 (June 12, 1997). Guidelines Establishing Test Procedures for the Analysis of Pollutants; Application for Approval of Alternate Test Procedures. Fed. Reg. 62(108):30761–30763 (June 5, 1997). Microbial and Disinfectants-Disinfection By-products Advisory Committee: Notice of Open Meeting. Fed. Reg. 62(93):26504 (May 14, 1997). Microbial and Disinfectants-Disinfection By-products Advisory Committee: Notice of Open Meeting. Fed. Reg. 62(86):24445 (May 5, 1997). Draft Guidance for State Source Water Assessment and Protection Programs; Notice of Availability and Request for Comments. Fed. Reg. 62(70):17809–17810 (April 11, 1997). Guidelines Establishing Test Procedures for the Analysis of Pollutants. Fed. Reg. 62(56):3833 (March 24, 1997). Allotment of Drinking Water State Revolving Fund Monies; Notice. Fed. Reg. 62(52):12899– 12903 (March 18, 1997). National Primary Drinking Water Regulations: Analytical Methods for Radionuclides. Final Rule and Proposed Rule. Fed. Reg. 62(43):10167–10174 (March 5, 1997). National Primary Drinking Water Regulations: Analytical Methods for Radionuclides. Proposed Rule. Fed. Reg. 62(43):10175 (March 5, 1997). Establishment of the Microbial and Disinfectants-Disinfection By-products Advisory Committee. Fed. Reg. 62(35):8012 (Feb. 21, 1997).

1996 Peer Review of an Agency Arsenic Research Plan. Fed. Reg. 61(248):67800 (Dec. 24, 1996).

LISTING OF DRINKING WATER FEDERAL REGISTER NOTICES

963

Montana Board of Oil and Gas Conservation; Underground Injection Control (UIC) Program; Primacy Program Approval; Final Rule. Fed. Reg. 61(224):58931–58936 (Nov. 19, 1996). Allocation of Drinking Water State Revolving Fund Monies; Request for Comment. Fed. Reg. 61(212):56231–56234 (Oct. 31, 1996). Proposed Process for Reevaluating Cancer Assessments. Fed. Reg. 61(123):32799 (June 25, 1996). A Framework for Watershed-Based Trading. Fed. Reg. 61(113):29563 (June 11, 1996). Drinking Water; National Primary Drinking Water Regulations; Enhanced Surface Water Treatment Requirements; Notice. Fed. Reg. 61(104):26857–26858 (May 29, 1996). National Primary Drinking Water Regulations: Monitoring Requirements for Public Drinking Water Supplies; Final Rule. Fed. Reg. 61(94):24353–24388 (May 14, 1996). Proposed Guidelines for Carcinogen Risk Assessment; Notice. Fed. Reg. 61(79):17960–18011 (April 23, 1996). Maximum Contaminant Level Goals and National Primary Drinking Water Regulations for Lead and Copper; Proposed Rule. Fed. Reg. 61(72):16347–16371 (April 12, 1996). EPA’s Drinking Water Health Advisory Program. Fed. Reg. 61(67):15253–15254 (April 5, 1996). Cyanazine; Notice of Preliminary Determination to Terminate Special Review; Notice of Receipt of Requests for Voluntary Cancellation; Notice. Fed. Reg. 61(42):8185–8203 (March 1, 1996).

1995 Incentives for Self-policing: Discovery, Disclosure, Correction and Prevention of Violations. Fed. Reg. 60(246):66706–66712 (Dec. 22, 1995). Comprehensive Drinking Water Program Redirection Plan Availability of Draft Document and Request for Comment. Fed. Reg. 60(229):61254 (Nov. 29, 1995). Class V Wells—Regulatory Determination and Minor Revisions to the Underground Injection Control Regulations; Technical Corrections to the Regulations for Class I Wells. Fed. Reg. 60(166):44652–44668 (Aug. 28, 1995). National Primary and Secondary Drinking Water Regulations: Analytical Methods for Regulated Drinking Water Contaminants. Fed. Reg. 60(125):34084 (June 29, 1995). National Primary Drinking Water Regulations Implementation Primary Enforcement Responsibility. Fed. Reg. 60(124):33658–33661 (June 28, 1995).

1994 National Primary Drinking Water Regulations Sulfate; Proposed Rule. Fed. Reg. 59(243):65578–65604 (Dec. 20, 1994). National Primary and Secondary Drinking Water Regulations; Analytical Methods for Regulated Drinking Water Contaminants; Final Rule. Fed. Reg. 59(232):62456–62471 (Dec. 5, 1994). Atrazine, Simazine, and Cyanazine; Notice of Initiation of Special Review. Fed. Reg. 59(225):60412–60443 (Nov. 23, 1994).

964

LISTING OF DRINKING WATER FEDERAL REGISTER NOTICES

National Primary Drinking Water Regulations; Disinfectants and Disinfection Byproducts and Enhanced Surface Water Treatment; Announcement of Public Meeting Dates and Locations. Fed. Reg. 59(196):51522 (Oct. 12, 1994). National Primary Drinking Water Regulations; Implementation Primary Enforcement Responsibility; Proposed Rule. Fed. Reg. 59(151):40458–40461 (Aug. 8, 1994). National Primary Drinking Water Regulations; Enhanced Surface Water Treatment Requirements; Proposed Rule. Fed. Reg. 59(145):38832–38858 (July 29, 1994). National Primary Drinking Water Regulations; Disinfectants and Disinfection Byproducts; Proposed Rule. Fed. Reg. 59(145):38668–38829 (July 29, 1994). National Primary and Secondary Drinking Water Regulations; Analytical Methods for Regulated Drinking Water Contaminants; Notice of Data Availability. Fed. Reg. 59(134):35891–35893 (July 14, 1994). Drinking Water; National Primary Drinking Water Regulations; Synthetic Organic Chemicals and Inorganic Chemicals; National Primary Drinking Water Regulations Implementation; Monitoring for Unregulated Contaminants. Final Rule; Technical Amendments. Fed. Reg. 59(126):34320–34321 (July 1, 1994). Drinking Water; Maximum Contaminant Level Goals and National Primary Drinking Water Regulations for Lead and Copper. Final Rule; Technical Corrections. Fed. Reg. 59(125):33860–33864 (June 30, 1994). National Primary Drinking Water Regulations; Monitoring Requirements for Public Drinking Water Supplies. Proposed Rule; Notice of Extension of Public Comment Period. Fed. Reg. 59(50):11961–11962 (March 15, 1994). National Primary Drinking Water Regulations; Monitoring Requirements for Public Drinking Water Supplies; Cryptosporidium, Giardia, Viruses, Disinfection By-products, Water Treatment Plant Data, and Other Information Requirements; Proposed Rule. Fed. Reg. 59(28):6332–6444 (Feb. 10, 1994).

1993 Drinking Water Maximum Contaminant Level Goal; Fluoride; Notice of Intent Not to Revise Fluoride Drinking Water Standards. Fed. Reg. 58(248):68826–68827 (Dec. 29, 1993). National Primary and Secondary Drinking Water Regulations; Analytical Methods for Regulated Drinking Water Contaminants; Proposed Rule. Fed. Reg. 58(239):65622– 65632 (Dec. 15, 1993). National Primary Drinking Water Regulations; Analytical Trihalomethanes; Final Rule. Fed. Reg. 58(147):41344–41345 (Aug. 3, 1993).

1992 National Primary and Secondary Drinking Water Regulations; Fluoride; Update of Ongoing Review of National Primary and Secondary Drinking Water Regulations for Fluoride. Fed. Reg. 57(226):54957–54958 (Nov. 23, 1992). Establishment and Open Meeting of the Negotiated Rulemaking Advisory Committee for Disinfection By-products; Establishment of FACA Committee and Meeting Announcement. Fed. Reg. 57(220):53866 (Nov. 13, 1992).

LISTING OF DRINKING WATER FEDERAL REGISTER NOTICES

965

Intent to Form an Advisory Committee to Negotiate the Drinking Water Disinfection Byproducts Rule and Announcement of Public Meeting; Notice of Intent. Fed. Reg. 57(179):42533–42536 (Sept. 15, 1992). Draft Groundwater Disinfection Rule Available for Public Comment; Notice of Availability and Review. Fed. Reg. 57(148):33960 (July 31, 1992). National Primary Drinking Water Regulations; Synthetic Organic Chemicals and Inorganic Chemicals; Final Rule. Fed. Reg. 57(138):31776–31849 (July 17, 1992). Drinking Water Regulations; Maximum Contaminant Level Goals and National Primary Drinking Water Regulations for Lead and Copper; Final Rule; Correcting Amendments. Fed. Reg. 57(125):28785–28789 (June 29, 1992). National Primary Drinking Water Regulations; Analytical Techniques; Coliform Bacteria; Final Rule. Fed. Reg. 57(112):24744–24747 (June 10, 1992). Drinking Water; National Primary Drinking Water Regulations; Aldicarb, Aldicarb Sulfoxide, and Aldicarb Sulfone; Notice of Pstponement of Certain Provisions of Final Rule. Fed. Reg. 57(102):22178–22179 (May 27, 1992). National Primary Drinking Water Regulations; Analytical Techniques; Coliform Bacteria; Final Rule. Fed. Reg. 57(10):1850–1852 (Jan. 15, 1992).

1991 Drinking Water; National Primary Drinking Water Regulations; Synthetic Organic Chemicals and Inorganic Chemicals; Notice of Availability with Request for Comments. Fed. Reg. 56(230):60949–60956 (Nov. 29, 1991). National Primary Drinking Water Regulations; Radionuclides; Notice of Corrections to Proposed Rule; Notice of Extension of Public Comment Period. Fed. Reg. 56(202):52241 (Oct. 18, 1991). National Primary Drinking Water Regulations; Analytical Techniques; Coliform Bacteria; Notice of Availability. Fed. Reg. 56(188):49153–49154 (Sept. 27, 1991). National Primary Drinking Water Regulations; Radionuclides; Notice of Corrections to Proposed Rule. Fed. Reg. 56(170):43573–43574 (Sept. 3, 1991). National Primary Drinking Water Regulations; Radionuclides; Proposed Rule. Fed. Reg. 56(138):33050–33127 (July 18, 1991). Drinking Water Regulations; Maximum Contaminant Level Goals and National Primary Drinking Water Regulations for Lead and Copper; Final Rule; Correction. Fed. Reg. 56(135):32112–32113 (July 15, 1991). National Primary Drinking Water Regulations; Monitoring for Volatile Organic Chemicals; MCLGs and MCLs for Aldicarb, Aldicarb Sulfoxide, Aldicarb Sulfone, Pentachlorophenol, and Barium; Final Rule. Fed. Reg. 56(126):30266–30281 (July 1, 1991). Maximum Contaminant Level Goals and National Primary Drinking Water Regulations for Lead and Copper; Final Rule. Fed. Reg. 56(110):26460–26564 (June 7, 1991). National Primary Drinking Water Regulations Implementation; Primary Enforcement Responsibility; Final Rulemaking. Fed. Reg. 56(106):25046–25050 (June 3, 1991). National Primary Drinking Water Regulations; Monitoring for Synthetic Organic Chemicals; MCLGs and MCLs for Aldicarb, Aldicarb Sulfoxide, Aldicarb Sulfone, Pentachlorophenol, and Barium; Proposed Rule. Fed. Reg. 56(20):3600–3614 (Jan. 30, 1991).

966

LISTING OF DRINKING WATER FEDERAL REGISTER NOTICES

National Primary Drinking Water Regulations; Synthetic Organic Chemicals and Inorganic Chemicals; Monitoring for Unregulated Contaminants; National Primary Drinking Water Regulations Implementation; National Secondary Drinking Water Regulations; Final Rule. Fed. Reg. 56(20):3526–3597 (Jan. 30, 1991). Drinking Water; National Primary Drinking Water Regulations; Total Coliforms; Partial Stay of Certain Provisions of Final Rule. Fed. Reg. 56(10):1556–1557 (Jan. 15, 1991). Priority List of Substances which May Require Regulation under the Safe Drinking Water Act; Notice. Fed. Reg. 56(9):1470–1474 (Jan. 14, 1991). National Primary Drinking Water Regulations; Analytical Techniques; Coliform Bacteria; Final Rule. Fed. Reg. 56(5):636–643 (Jan. 8, 1991).

1990 National Primary Drinking Water Regulations Implementation; Primary Enforcement Responsibility; Notice of Proposed Rulemaking. Fed. Reg. 55(229):49398–49399 (Nov. 28, 1990). Variances and Exemptions for Primary Drinking Water Regulations; Unreasonable Risk to Health Guidance. Fed. Reg. 55(191):40205 (Oct. 2, 1990). National Primary and Secondary Drinking Water Regulations; Synthetic Organic Chemicals and Inorganic Chemicals; Proposed Rule. Fed. Reg. 55(143):30370–30448 (July 25, 1990). National Primary Drinking Water Regulations; Analytical Techniques; Coliform Bacteria; Proposed Rule. Fed. Reg. 55(106):22752–22756 (June 1, 1990). National Primary and Secondary Drinking Water Regulations; Fluoride; Request for Information. Fed. Reg. 55(2):160–161 (Jan. 3, 1990).

1989 National Primary Drinking Water Regulations Implementation; Primary Enforcement Responsibility; Final Rule. Fed. Reg. 54(243):52126–52140 (Dec. 20, 1989). National Primary Drinking Water Regulations; Analytical Techniques; Coliform Bacteria; Final Rule. Fed. Reg. 54(135):29998–30002 (July 17, 1989). Drinking Water; National Primary Drinking Water Regulations; Total Coliforms (Including Fecal Coliforms and E. coli); Final Rule. Fed. Reg. 54(124):27544–27568 (June 29, 1989). Drinking Water; National Primary Drinking Water Regulations; Filtration, Disinfection; Turbidity, Giardia lamblia, Viruses, Legionella, and Heterotrophic Bacteria; Final Rule. Fed. Reg. 54(124):27486–27541 (June 29, 1989). National Primary and Secondary Drinking Water Regulations; Proposed Rule. Fed. Reg. 54(97):22062–22160 (May 22, 1989). Drinking Water Regulations; Public Notification; Final Rule; Technical Amendment. Fed. Reg. 54(72):15185–15188 (April 17, 1989).

1988 Drinking Water Regulations; Maximum Contaminant Level Goals and National Primary Drinking Water Regulations for Lead and Copper; Proposed Rule. Fed. Reg. 53(160):31516–31553 (Aug. 18, 1988).

LISTING OF DRINKING WATER FEDERAL REGISTER NOTICES

967

National Primary Drinking Water Regulations Implementation; Primary Enforcement Responsibility; Proposed Rule. Fed. Reg. 53:29194–29207 (Aug. 2, 1988). National Primary Drinking Water Regulations; Synthetic Organic Chemicals; Monitoring for Unregulated Contaminants; Correction; Final Rule. Fed. Reg. 53(127):25108–25111 (July 1, 1988). National Primary Drinking Water Regulations; Filtration and Disinfection; Turbidity, Giardia lamblia, Viruses, Legionella, and Heterotrophic Bacteria; Total Coliforms; Notice of Availability; Close of Public Comment Period; Proposed Rule. Fed. Reg. 53(88):16348– 16358 (May 6, 1988). Drinking Water; Substitution of Contaminants and Drinking Water Priority List of Additional Substances which May Require Regulation Under the Safe Drinking Water Act. Fed. Reg. 53(14):1892–1902 (Jan. 22, 1988).

1987 Drinking Water; National Primary Drinking Water Regulation; Total Coliforms; Proposed Rule. Fed. Reg. 52(212):42224–42245 (Nov. 3, 1987). National Primary Drinking Water Regulation; Filtration and Disinfection; Turbidity, Giardia lamblia, Viruses, Legionella, and Heterotrophic Bacteria; Proposed Rule. Fed. Reg. 52(212):42178–42222 (Nov. 3, 1987). Drinking Water Regulations; Public Notification; Final Rule. Fed. Reg. 52(208):41534–41550 (Oct. 28, 1987). Drinking Water; Proposed Substitution of Contaminants and Proposed List of Additional Substances which May Require Regulation under the Safe Drinking Water Act. Fed. Reg. 52(130):25720–25734 (July 8, 1987). National Primary Drinking Water Regulations; Synthetic Organic Chemicals; Monitoring for Unregulated Contaminants; Final Rule. Fed. Reg. 52(130):25690–25717 (July 8, 1987). Water Pollution Control; National Primary Drinking Water Regulations; Volatile Synthetic Organic Chemicals; Paradichlorobenzene; Proposed Rule. Fed. Reg. 52(74):12876–12883 (April 17, 1987).

1986 Water Pollution Control; National Primary Drinking Water Regulations; Radionuclides; Advanced Notice of Proposed Rulemaking. Fed. Reg. 51(189):34836–34862 (Sept. 30, 1986). National Primary and Secondary Drinking Water Regulations; Fluoride; Final Rule. Fed. Reg. 51(63):11396–11412 (April 2, 1986).

1985 National Primary Drinking Water Regulations; Fluoride; Proposed Rule. Fed. Reg. 50(220):47156–47171 (Nov. 14, 1985). National Primary Drinking Water Regulations; Fluoride; Final Rule. Fed. Reg. 50(220):47142– 47155 (Nov. 14, 1985).

968

LISTING OF DRINKING WATER FEDERAL REGISTER NOTICES

National Primary Drinking Water Regulations; Synthetic Organic Chemicals, Inorganic Chemicals, and Microorganisms; Proposed Rule. Fed. Reg. 50(219):46936–47022 (Nov. 13, 1985). National Primary Drinking Water Regulations; Volatile Synthetic Organic Chemicals; Proposed Rule. Fed. Reg. 50(219):46902–46933 (Nov. 13, 1985). National Primary Drinking Water Regulations; Volatile Synthetic Organic Chemicals; Final Rule. Fed. Reg. 50(219):46880–46901 (Nov. 13, 1985). Fluoride; National Primary Drinking Water Regulations; Proposed Rule. Fed. Reg. 50(93):20164–20175 (May 14, 1985).

1984 National Primary Drinking Water Regulations; Volatile Synthetic Organic Chemicals; Proposed Rulemaking. Fed. Reg. 49(114):24330–24355 (June 12, 1984).

1983 National Revised Primary Drinking Water Regulations; Advanced Notice of Proposed Rulemaking. Fed. Reg. 48(194):45502–45521 (Oct. 5, 1983). National Interim Primary Drinking Water Regulations; Trihalomethanes; Final Rule. Fed. Reg. 48(40):8406–8414 (Feb. 28, 1983).

1982 National Interim Primary Drinking Water Regulations; Trihalomethanes. Proposed Rule. Fed. Reg. 47(44):9796–9799 (March 5, 1982). National Revised Primary Drinking Water Regulations; Volatile Synthetic Organic Chemicals in Drinking Water; Advanced Notice of Proposed Rulemaking. Fed. Reg. 47(43):9350– 9358 (March 4, 1982).

1981 Interim Primary Drinking Water Regulations; Control of Organic Chemicals in Drinking Water; Notice of Withdrawal. Fed. Reg. 46(53):17567 (March 19, 1981).

1980 Interim Primary Drinking Water Regulations; Amendments. Fed. Reg. 45(168):57332–57357 (Aug. 27, 1980).

1979 National Interim Primary Drinking Water Regulations; Control of Trihalomethanes in Drinking Water; Final Rule. Fed. Reg. 44(231):68624–68707 (Nov. 29, 1979).

LISTING OF DRINKING WATER FEDERAL REGISTER NOTICES

969

National Secondary Drinking Water Regulations; Final Rule. Fed. Reg. 44(140):42195–42202 (July 19, 1979).

1978 Interim Primary Drinking Water Regulations; Control of Organic Chemicals; Notice of Availability. Fed. Reg. 43(130):29135 (July 6, 1978). Interim Primary Drinking Water Regulations; Control of Organic Chemical Contaminants in Drinking Water; Proposed Rule. Fed. Reg. 43(28):5756–5780 (Feb. 9, 1978).

1977 Drinking Water and Health; Recommendations of the National Academy of Sciences. Fed. Reg. 42(132):35764–35779 (July 11, 1977).

1976 Organic Chemical Contaminants; Control Options in Drinking Water. Fed. Reg. 41(136):28991–28998 (July 14, 1976). National Interim Primary Drinking Water Regulations; Promulgation of Regulations on Radionuclides. Fed. Reg. 41(133):28402–28409 (July 9, 1976). National Primary Drinking Water Regulations Implementation; Primary Enforcement Responsibility; Final Rule. Fed. Reg. 41:2917 (Jan. 20, 1976).

1975 Drinking Water Regulations; Public Notification; Final Rule. Fed. Reg. 40:59570 (Dec. 24, 1975). National Interim Primary Drinking Water Regulations. Fed. Reg. 40(248):59566–59588 (Dec. 24, 1975).

1962 U.S. Public Health Service (USPHS); Drinking Water Standards. Fed. Reg. 27:2152–2155 (March 6, 1962).

APPENDIX H OUTLINE OF 40 CFR 141, 142, AND 143 COMPILED BY FREDERICK W. PONTIUS, P.E. Pontius Water Consultants, Inc., Lakewood, Colorado

PART 141—NATIONAL PRIMARY DRINKING WATER REGULATIONS Subpart A—General Section 141.1 Applicability 141.2 Definitions 141.3 Coverage 141.4 Variances and Exemptions 141.5 Siting Requirements 141.6 Effective Dates Subpart 141.11 141.12 141.13 141.15

B—Maximum Contaminant Levels Maximum Contaminant Levels for Inorganic Chemicals Maximum Contaminant Levels for Total Trihalomethanes Maximum Contaminant Levels for Turbidity Maximum Contaminant Levels for Radium-226, Radium-228, and Gross Alpha Particle Radioactivity in Community Water Systems 141.16 Maximum Contaminant Levels for Beta Particle and Photon Radioactivity from Man-made Radionuclides in Community Water Systems Subpart C—Monitoring and Analytical Requirements 141.21 Coliform Sampling 141.22 Turbidity Sampling and Analytical Requirements Drinking Water Regulation and Health, Edited by Frederick W. Pontius. ISBN 0-471-41554-5 # 2003 John Wiley & Sons, Inc.

971

972

OUTLINE OF 40 CFR 141, 142, AND 143

141.23 141.24 141.25 141.26 141.27 141.28 141.29 141.30

Inorganic Chemical Sampling and Analytical Requirements Organic Chemicals, Sampling and Analytical Requirements Analytical Methods for Radioactivity Monitoring Frequency for Radioactivity in Community Water Systems Alternate Analytical Techniques Certified Laboratories Monitoring of Consecutive Public Water Systems Total Trihalomethanes Sampling, Analytical and Other Requirements

Subpart 141.31 141.32 141.33 141.34 141.35

D—Reporting and Recordkeeping Reporting Requirements Public Notification Record Maintenance [Reserved] Reporting of Unregulated Contaminant Monitoring Results

Subpart E—Special Regulations, Including Monitoring Regulations and Prohibition on Lead Use 141.40 Monitoring Requirements for Unregulated Contaminants 141.41 Special Monitoring for Sodium 141.42 Special Monitoring for Corrosivity Characteristics 141.43 Prohibition on Use of Lead Pipes, Solder, and Flux Subpart F—Maximum Contaminant Level Goals and Maximum Residual Disinfectant Level Goals 141.50 Maximum Contaminant Level Goals for Organic Contaminants 141.51 Maximum Contaminant Level Goals for Inorganic Contaminants 141.52 Maximum Contaminant Level Goals for Microbiological Contaminants 141.53 Maximum Contaminant Level Goals for Disinfection Byproducts 141.54 Maximum Residual Disinfectant Level Goals for Disinfectants Subpart G—National Revised Primary Drinking Water Regulations: Maximum Contaminant Levels and Maximum Residual Disinfectant Levels 141.60 Effective Dates 141.61 Maximum Contaminant Levels for Organic Contaminants 141.62 Maximum Contaminant Levels for Inorganic Contaminants 141.63 Maximum Contaminant Levels (MCLs) for Microbiological Contaminants 141.64 Maximum Contaminant Levels for Disinfection Byproducts 141.65 Maximum Residual Disinfectant Levels Subpart 141.70 141.71 141.72 141.73

H—Filtration and Disinfection General Requirements Criteria for Avoiding Filtration Disinfection Filtration

OUTLINE OF 40 CFR 141, 142, AND 143

141.74 141.75

973

Analytical and Monitoring Requirements Reporting and Recordkeeping Requirements

Subpart I—Control of Lead and Copper 141.80 General Requirements 141.81 Applicability of Corrosion Control Treatment Steps to Small, Medium-size and Large Water Systems 141.82 Description of Corrosion Control Treatment Requirements 141.83 Source Water Treatment Requirements 141.84 Lead Service Line Replacement Requirements 141.85 Public Education and Supplemental Monitoring Requirements 141.86 Monitoring Requirements for Lead and Copper in Tap Water 141.87 Monitoring Requirements for Water Quality Parameters 141.88 Monitoring Requirements for Lead and Copper in Source Water 141.89 Analytical Methods 141.90 Reporting Requirements 141.91 Recordkeeping Requirements Subpart J—Use of Non-Centralized Treatment Devices 141.100 Criteria and Procedures for Public Water Systems Using Point-of-Entry Devices 141.101 Use of Bottled Water Subpart K—Treatment Techniques 141.110 General Requirements 141.111 Treatment Techniques for Acrylamide and Epichlorohydrin Subpart L—Disinfectant Residuals, Disinfection Byproducts, and Disinfection Byproduct Precursors 141.130 General Requirements 141.131 Analytical Requirements 141.132 Monitoring Requirements 141.133 Compliance Requirements 141.134 Reporting and Recordkeeping Requirements 141.135 Treatment Technique for Control of Disinfection Byproduct (DBP) Precursors Subpart M—Information Collection Requirements (ICR) for Public Water Systems 141.140 Definitions Specific to Subpart M 141.141 General Requirements, Applicability, and Schedule for Information Collection 141.142 Disinfection Byproduct and Related Monitoring 141.143 Microbial Monitoring 141.144 Disinfection Byproduct Precursor Removal Studies

974

OUTLINE OF 40 CFR 141, 142, AND 143

Subpart O—Consumer Confidence Reports 141.151 Purpose and Applicability of This Subpart 141.152 Effective Dates 141.153 Content of the Reports 141.154 Required Additional Health Information 141.155 Report Delivery and Recordkeeping

APPENDIX A TO SUBPART O—REGULATED CONTAMINANTS Subpart P—Enhanced Filtration and Disinfection 141.170 General Requirements 141.171 Criteria for Avoiding Filtration 141.172 Disinfection Profiling and Benchmarking 141.173 Filtration 141.174 Filtration Sampling Requirements 141.175 Reporting and Recordkeeping Requirements Subpart Q—Public Notification of Drinking Water Violations 141.201 General Public Notification Requirements 141.202 Tier 1 Public Notice—Form, Manner, and Frequency of Notice 141.203 Tier 2 Public Notice—Form, Manner, and Frequency of Notice 141.204 Tier 3 Public Notice—Form, Manner, and Frequency of Notice 141.205 Content of the Public Notice 141.206 Notice to New Billing Units or New Customers 141.207 Special Notice of the Availability of Unregulated Contaminant Monitoring Results 141.208 Special Notice for Exceedance of the SMCL for Fluoride 141.209 Special Notice for Nitrate Exceedances above MCL by Non-community Water Systems (NCWS), Where Granted Permission by the Primacy Agency under §141.11(d) 141.210 Notice by Primacy Agency on Behalf of the Public Water System

APPENDIX A TO SUBPART Q OF PART 141—NPDWR VIOLATIONS AND SITUATIONS REQUIRING PUBLIC NOTICE

APPENDIX B TO SUBPART Q OF PART 141—STANDARD HEALTH EFFECTS LANGUAGE FOR PUBLIC NOTIFICATION

APPENDIX C TO SUBPART Q OF PART 141—LIST OF ACRONYMS USED IN PUBLIC NOTIFICATION REGULATION

OUTLINE OF 40 CFR 141, 142, AND 143

975

PART 142—NATIONAL PRIMARY DRINKING WATER REGULATIONS IMPLEMENTATION Subpart A—General Provisions Section 142.1 Applicability 142.2 Definitions 142.3 Scope 142.4 State and Local Authority Subpart 142.10 142.11 142.12 142.13 142.14 142.15 142.16 142.17

B—Primary Enforcement Responsibility Requirements for a Determination of Primary Enforcement Responsibility Initial Determination of Primary Enforcement Responsibility Revision of State Programs Public Hearing Records Kept by States Reports by States Special Primacy Requirements Review of State Programs and Procedures for Withdrawal of Approved Primacy Programs 142.18 EPA Review of State Monitoring Determinations 142.19 EPA Review of State Implementation of National Primary Drinking Water Regulations for Lead and Copper Subpart C—Review of State-Issued Variances and Exemptions 142.20 State-Issued Variances and Exemptions under Section 1415(a) and Section 1416 of the Act 142.21 State Consideration of a Variance or Exemption Request 142.22 Review of State Variances, Exemptions and Schedules 142.23 Notice to State 142.24 Administrator’s Rescission Subpart 142.30 142.31 142.32 142.33 142.34

D—Federal Enforcement Failure by State to Assure Enforcement [Reserved] Petition for Public Hearing Public Hearing Entry and Inspection of Public Water Systems

Subpart E—Variances Issued by the Administrator Under Section 1415(a) of the Act 142.40 Requirements for a Variance 142.41 Variance Request 142.42 Consideration of a Variance Request 142.43 Disposition of a Variance Request

976

OUTLINE OF 40 CFR 141, 142, AND 143

142.44 142.45 142.46

Public Hearings on Variances and Schedules Action after Hearing Alternative Treatment Techniques

Subpart 142.50 142.51 142.52 142.53 142.54 142.55 142.56 142.57

F—Exemptions Issued by the Administrator Requirements for an Exemption Exemption Request Consideration of an Exemption Request Disposition of an Exemption Request Public Hearings on Exemption Schedules Final Schedule Extension of Date for Compliance Bottled Water, Point-of-Use, and Point-of-Entry Devices

Subpart G—Identification of Best Technology, Treatment Techniques or Other Means Generally Available 142.60 Variances from the Maximum Contaminant Level for Total Trihalomethanes 142.61 Variances from the Maximum Contaminant Level for Fluoride 142.62 Variances and Exemptions from the Maximum Contaminant Levels for Organic and Inorganic Chemicals 142.63 Variances and Exemptions from the Maximum Contaminant Level for Total Coliforms 142.64 Variances and Exemptions from the Requirements of Part 141, Subpart H—Filtration and Disinfection Subpart 142.72 142.76 142.78

H—Indian Tribes Requirements for Tribal Eligibility Request by an Indian Tribe for a Determination of Eligibility Procedure for Processing an Indian Tribe’s Application

Subpart I—Administrator’s Review of State Decisions that Implement Criteria under Which Filtration Is Required 142.80 Review Procedures 142.81 Notice to the State Subpart J—[Reserved] Subpart K—Variances for Small System GENERAL PROVISIONS 142.301 142.302 142.303

What Is a Small System Variance? Who Can Issue a Small System Variance? Which Size Public Water Systems Can Receive a Small System Variance?

OUTLINE OF 40 CFR 141, 142, AND 143

142.304 142.305

977

For Which of the Regulatory Requirements is a Small System Variance Available? When Can a Small System Variance be Granted by a State?

REVIEW OF SMALL SYSTEM VARIANCE APPLICATION 142.306

142.307

What are the Responsibilities of the Public Water System, State and the Administrator in Ensuring that Sufficient Information is Available and for Evaluation of a Small System Variance Application? What Terms and Conditions Must be Included in a Small System Variance?

PUBLIC PARTICIPATION 142.308 142.309 142.310

What Public Notice is Required before a State or the Administrator Proposes to Issue a Small System Variance? What are the Public Meeting Requirements Associated with the Proposal of a Small System Variance? How Can a Person Served by the Public Water System Obtain EPA Review of a State Proposed Small System Variance?

EPA REVIEW AND APPROVAL OF SMALL SYSTEM VARIANCES 142.311

142.312

142.313

What Procedures Allow for the Administrator to Object to a Proposed Small System Variance or Overturn a Granted Small System Variance for a Public Water System Serving 3,300 or Fewer Persons? What EPA Action is Necessary when a State Proposes to Grant a Small System Variance to a Public Water System Serving a Population of More than 3,300 and Fewer than 10,000 Persons? How Will the Administrator Review a State’s Program under This Subpart?

PART 143—NATIONAL SECONDARY DRINKING WATER REGULATIONS Section 143.1 Purpose 143.2 Definitions 143.3 Secondary Maximum Contaminant Levels 143.4 Monitoring

APPENDIX I EXAMPLE CAPACITY DEVELOPMENT TOOL SOUTH DAKOTA DEPARTMENT OF ENVIRONMENT AND NATURAL RESOURCES

Drinking Water Regulation and Health, Edited by Frederick W. Pontius. ISBN 0-471-41554-5 # 2003 John Wiley & Sons, Inc.

979

980

EXAMPLE CAPACITY DEVELOPMENT TOOL

EXAMPLE CAPACITY DEVELOPMENT TOOL

981

982

EXAMPLE CAPACITY DEVELOPMENT TOOL

EXAMPLE CAPACITY DEVELOPMENT TOOL

983

984

EXAMPLE CAPACITY DEVELOPMENT TOOL

EXAMPLE CAPACITY DEVELOPMENT TOOL

985

986

EXAMPLE CAPACITY DEVELOPMENT TOOL

EXAMPLE CAPACITY DEVELOPMENT TOOL

987

988

EXAMPLE CAPACITY DEVELOPMENT TOOL

EXAMPLE CAPACITY DEVELOPMENT TOOL

989

990

EXAMPLE CAPACITY DEVELOPMENT TOOL

EXAMPLE CAPACITY DEVELOPMENT TOOL

991

992

EXAMPLE CAPACITY DEVELOPMENT TOOL

EXAMPLE CAPACITY DEVELOPMENT TOOL

993

994

EXAMPLE CAPACITY DEVELOPMENT TOOL

APPENDIX J U.S. WATER INDUSTRY STATISTICS USEPA OFFICE OF GROUND WATER AND DRINKING WATER

Drinking Water Regulation and Health, Edited by Frederick W. Pontius. ISBN 0-471-41554-5 # 2003 John Wiley & Sons, Inc.

995

996

U.S. WATER INDUSTRY STATISTICS

U.S. WATER INDUSTRY STATISTICS

997

998

U.S. WATER INDUSTRY STATISTICS

U.S. WATER INDUSTRY STATISTICS

999

1000

U.S. WATER INDUSTRY STATISTICS

U.S. WATER INDUSTRY STATISTICS

1001

1002

U.S. WATER INDUSTRY STATISTICS

U.S. WATER INDUSTRY STATISTICS

1003

1004

U.S. WATER INDUSTRY STATISTICS

U.S. WATER INDUSTRY STATISTICS

1005

1006

U.S. WATER INDUSTRY STATISTICS

U.S. WATER INDUSTRY STATISTICS

1007

1008

U.S. WATER INDUSTRY STATISTICS

INDEX AA, see Activated alumina Ability to pay, 468, 471, 473 Abortion rate, association with THMs, 172 Absorbed dose, 312 Acceptable risk, 192 Acquisition of water systems, 461 Activated alumna (AA), 394, 415 Active disease reporting, 28 Acute exposure, 144 Acute toxicity, 136 Adenovirus, 62, 64 Administrative orders, 668 Administrative Procedure Act (APA), 253, 263 Adsorbent media processes, 394, 415 Advanced oxidation processes (AOPs), 391 Advanced treatment technology, 386 Affordability, 464, 470–472, 483 ability to pay, 473 affordable technologies, 470 assistance programs, 473 criteria, state development, 470 disadvantaged communities, 470 grants, 476 increasing-block rates, 475 lifeline rates, 475, 476 loans, 476, 480 rate design, 475 small system variances, 470 state revolving loan funds, 470, 476 subsidies, 476, 481 sustainability, 473 utility assistance programs, 473 variance technologies, 470 voucher=coupon programs, 475 willingness to pay, 473 Affordable compliance technology, 296 Agency for Toxic Substances Disease Registry (ATSDR), 492 Agricultural competition for drinking water, 126 AIDs, 498–500. See also Sensitive subpopulations

Algae, 54 AlliedSignal, Inc. v. City of Phoenix lawsuit, 552 Alpha emitters, 315, 323 Alpha-particle emitters, see Alpha emitters Alternative maximum containment level (AMCL), 526 Amchem Products v. Windsor lawsuit, 545 AMCL, see Alternative maximum containment level Amebic meningoencephalitis, 53, 55, 61, 67 American National Standards Institute (ANSI), 386 Analogical reasoning, 200 Animal studies, 137 ANPRM, see USEPA Advance Notice of Proposed Rulemaking ANSI, see American National Standards Institute Anthrax-tainted letters, 567 Antibacksliding in the 1996 SDWA amendments, 319 AOPs, see Advanced oxidation processes APA, see Administrative Procedure Act Application of sound science to public policy, 209 Appropriations, congressional, 110 Aqueducts, Roman, 4 Aquifer protection areas, SDWA requirements, 682, 793–797 AR, see Attributable risk Arsenic, 119, 177, 590 association with bladder cancer, 175 interaction with carcinogens, 177 lawsuits, 552 poisoning, 503 removal, 385, 427 SDWA requirements, 656, 750–751 synergistic effect with smoking, 177 Asbestos exposure lawsuits, 545 Assessing causation, 211 Assumptions in benefit-cost analysis, 244 1009

1010

INDEX

Asthma, 494, 502 Asymptomatic carriers, 36 ATSDR, see Agency for Toxic Substances Disease Registry Attributable risk (AR), 167 Austrobilharzia variglandis, 61 Authority in science, 199 Authorization, congressional, 110 Availability of treatment chemicals, SDWA requirements, 690, 807–809

Backflow prevention devices, 65 Backsiphonage, 58, 65 Backwash, 299 SDWA requirements, 659, 754 Bacteria, coliform, see Coliform bacteria Bacterial plate counts, 282. See also Heterotrophic plate count Bacterial outbreaks, 54 BAT, see Best available technology BCA, see Benefit-cost analysis Becquerels, 311 Benchmark dose (BMD), 140 Benchmarking, 298 Bendectin lawsuit, 542 Benefit transfer (BT), 238 Benefit-cost analysis, 226, 229 adjusting value of a statistical life (VSL), 239 assumptions, 244 central tendencies, 244 conservative assumptions, 244 cost justification, 227 cost of illness, 237 discounting costs and benefits, 240 discounting latency periods, 241 historical application, 227 income adjusted value of a statistical life (VSL), 241 incremental benefits and costs, 230 latency periods, 239 life years saved (LYS), 234 mandated by SDWA, 226 omitted benefits and costs, 246 political debate, 117–118 pre 1996 SDWA, 228 precautionary assumptions, 244 quality-adjusted life years (QALYs), 234 Radon Rule, 233 SDWA requirements, 654, 748 statistical life, 234 system size differences, 231

uncertainty factors (UF), 243 uncertainty, 242 unquantified benefits and costs, 246 uranium, 331 use of benefit transfer, 238 value of a statistical life (VSL), 234, 236 variability, 242 willingness to pay, 236 Benefits in regulatory policy, 233 Benzene lawsuit, 541 Best available science, 220 Best available technology (BAT), 296, 382. See also Feasible technologies for disinfectants and disinfection byproducts (DBPs), 297 for radionuclides, 326 for regulated contaminants, 613–617 SDWA requirements, 652–653, 746–747 Beta and photon emitters, 332 Beta-particle emitters, 315 Bias in case-control studies, 164 Bias in research, 202 Bill approval by the President, 916, 947 Bill veto by the President, 915–917, 947 Bill enactment, 871–922, 923–951 Biodegradable organic matter (BOM), 394 Bioinformatics, 376 Biological and Toxin Weapons Convention (BTWC), 569 Biological effects of chemical exposure, 135 Biological filtration, 394 Bladder cancer mortality in relation to chlorinated water, 174 Blinded study definition, 167 BMD, see Benchmark dose BOM, see Biodegradable organic matter Border and Transportation Security, Department of Homeland Security (DHS), 577 Bottled water, 43, 301, 440, 427 Botulinum toxin, 569 Bromate, 589 BT, see Benefit transfer BTWC, see Biological and Toxin Weapons Convention Budget process, congressional, 903, 948 Bureau of Citizenship and Immigration Services, Department of Homeland Security (DHS), 577 Bureaucratese, 204 Cabinet, 106 Campylobacter, 56, 61–62

INDEX

Cancer, 495–497 association with arsenic, 175 association with chlorinated water, 158, 172, 174 association with radiation, 313 classification categories, 138 guidelines, 143 latency periods, 239 mortality, 172, 174, 496 risks, 139, 141, 174 slope factors, 192 Capacity, 124, 450. See also Water systems, capacity Capacity development, 450, 469 example tool, 979–994 SDWA requirements, 677–680, 779–783 Carbon chloroform (CCE) standard, 16 Carcinogens, 116, 191 Cardiovascular disease, 152 Case-control study, 159–163, 174 CASRN, see Chemical Abstracts Service Registry Numbers Castellow v. Chevron USA lawsuit, 541 Causality in epidemiologic studies, 168, 169 Causation, 211 CCE, see Carbon chloroform extract CCL, see Contaminant Candidate List CDC, see Center for Disease Control and Prevention Center for Disease Control and Prevention (CDC), 46 Central tendencies in benefit-cost analysis, 244 CERCLA, 538. See also Comprehensive Environmental Response Compensation and Liability Act Certification of operators, SDWA requirements, 675–677, 778–779 CFR, see Code of Federal Regulations Chadwick, Sir Edwin, 9 Chemical Abstracts Service Registry Numbers (CASRN), 583 Chemical warfare (CW) agents, 569 Chemical Warfare Convention (CWC), 569 Chemicals, 62 exposure, 136 inorganic, 590 organic, 593 outbreaks, 62 poisoning, 57, 58 Chemotherapy, 501 Chesapeake, Virginia lawsuit, 534 Children, 493, 517, 523, 569. See also Sensitive subpopulations Chloramines, 174, 590

1011

Chlorination, 13 Chlorine, 174, 590 Chlorine dioxide, 590 Chlorine residuals, 65, 590 Chlorite, 589 Chloroform, 74, 191, 211 Chloroform MCLG, 141, 219, 295 Cholera, 7–9, 20, 150–151, 201 Chronic illnesses, 494 Chronic toxicity, 136 CI, see Confidence interval Cisterns, 5 Citizen’s civil action, SDWA requirements, 699–700, 826–828 City of Evansville v. Kentucky Liquid Recycling, Inc., lawsuit, 551 City of Waukesha v. EPA, 2003, 310, 315, 322, 333, 335 Civil action, SDWA requirements, 662–663, 699–700, 826–828 Civil rights, 515 Class action lawsuits, 544–547 Classifying future contaminant for regulation consideration, 358 Clean Air Act, lawsuit, 551 Clean Water Act, lawsuit, 551 Cleanup costs of radionuclides, 336 Cleanup of Superfund sites, 332–334 Code of Federal Regulations, 253, 971–977 Cohort studies, 159, 172 COI, see Cost of illness Coliform bacteria as indicator organisms, 278, 281 distribution in distribution systems, 285 early regulations, 14 indicators, 67 MCL, 588 monitoring, 67, 619 presence during outbreaks, 59–60 sampling, 281, 286 Coliform group, 280. See also Coliform bacteria Coliforms, 280. See also Coliform bacteria Colonias, 716, 846–847 Comment periods, 259 Communications, with customers, 441–446 Community intervention studies, definition, 160 Community Right-to-Know Act, 574 Community Water Supply Study (CWSS), 18, 73, 114 Community water systems, 10, 48, 999–1001,1004–1007. See also Water systems

1012

INDEX

Compliance cost, 247, 331, 398 multiple regulations, 395 simultaneous, 395 small system, 124 technologies and affordability, 475 technology selection, 383–386, 396 Composite Correction Program, 396 Comprehensive Environmental Response Compensation and Liability Act (CERCLA), 332–334 Conference committee process, 109 Confidence interval (CI), 163 Confounding bias in epidemiologic studies, 165 Congressional appropriation, 110 authorization, 110 budget process, 903, 948 committees, 107, 108, 879–889, 936–938, 941–942 legislative process, 871–922, 923–951 Conservation planning, 472, 475 Conservation plans, 715–716, 846 Conservative assumptions, 190, 244 Consolidated rates, 483 Consolidation, 458 Consolidation incentive, 669 Consumer Confidence Reports, 443–444 lawsuit potential, 551 my eyes glaze over (MEGO), 444 SDWA requirements, 666–667, 761 Consumer confidence in their water, 438–439 Consumer Right-to-Know provisions of the 1996 amendments, 127 Consumers, See also Customers, Public relations Contaminant Candidate List (CCL), 341 1998 list, 347–349 Aristotelian strategy, 364 classification strategies, 363–367 example of prototype classification, 368–375 expert judgment, 363 future development of, 344 future lists, 356 neural networks, 377 NRC recommendations, 352–353, 376–378 pathogens, 293 PCCL, 360–363, 367 prototype classifications, 365–366, 376–377

regulatory decisions from the 1998 CCL, 355 rule-based methods, 364–365 SDWA requirements (identification of unregulated contaminants for listing), 648–650, 742–743 screening criteria, 363 universe of contaminants, 359–362 virulence factor-activity relationships (VFARs), 375–377 Contaminant monitoring, SDWA requirements, 673–675, 776–778 Contaminant occurrence database, SDWA requirements, 696, 821 Contaminants definition, 341 deliberate contamination, 575 future contaminants for regulatory consideration, 358 MCLs, 583–619 MCLGs, 583–619 potential for terrorist attack, 570 regulation of, 119 when SDWA mandates regulations, 341 unregulated contaminant monitoring, 693–695, 818–819 Contamination, 64, 65 acute exposure, 144 episodic, 144 historical, 7–9 lead, 80 prevention under the SDWA, 688–689, 805–806 Contamination of water systems, 59–60, 572 Copper poisoning, 57 Copyrights, 555 Corrosion, 58, 65 Cost assessments for treatment technology feasibility determinations, 382 Cost of illness (COI), 235–237 Cost of water, 464 Costing strategy, 486 Cost-of-service studies, 483 Council of State and Territorial Epidemiologists, 46 Coupon=voucher programs, 475 Court of Appeals, 217 Critical infrastructure, 578 Critical thinking, 205 Cross-connections, 58, 65 Croton Aqueduct, 11 Cryptosporidiosis, 63, 66, 159 Las Vegas outbreak, 38 Milwaukee outbreak, 27, 55, 49, 442

INDEX

Cryptosporidium, 56, 61, 62, 507, 588 analytical method, 293 in swimming pools, 67 inactivation, 390 membrane removal, 388 monitoring under LT2ESWTR, 300 ozone inactivation, 392 resistance to disinfection, 298 ultraviolet (UV) inactivation, 390 voluntary studies of dosage, 157 CT values, 289 Curies, 311 Customer satisfaction surveys, 439–441 Customers benefits of customer communications, 446 concerns about water, 438 confidence in water, 438–439 Consumer Confidence Reports, 443–444 demographics, 433–435 information sources, 436–437 planning communications, 444–445 satisfaction 439–441 stakeholder involvement, 445 CWC, see Chemical Warfare Convention CWSS, see Community Water Supply Study Cyber attack, 125 Cyclospora, 56

Daubert v. Merrell Dow Pharmaceuticals, Inc., lawsuit, 539, DBPs, see Disinfection byproducts Decay, radioactive, 311 Deductive reasoning, 200 Deference, judicial, 218 Deficiencies in public water systems, 58–59 Definitions, SDWA requirements, 719, 849–850 Department of Homeland Security (DHS), 576–578 Dermatitis, 53, 61, 63 Desalination, 389 Detection of outbreaks, 31 Developing-country water quality, 19–21 DHS, see Department of Homeland Security Diabetes, 494, 502–503 Diagnosed illnesses, 29 Diarrhea, 154 Disadvantaged persons, 515 Disagreement, scientific, 209 Discovery, lawsuits, 547 Discrimination, 515 Disease attack rate, 153

1013

frequency, measurements of, 152 incidents, 152 prevalence, 153 pyramid, 29 Disease reporting active, 28 disease surveillance system, 26, 38 events, 37 passive, 28 voluntary, 26 Disinfection best available technology, 297 inadequate, 60 mandatory SDWA requirements, 655–656, 750 MRDLGs and MRDLs, 590 ozone, 392 resistance of pathogens, 284 under the Ground Water Rule (GWR), 300 Disinfection byproducts (DBPs) best available technology, 297 bromate, 589 chlorite, 589 control in the 1970s, 280–284 control in the 1980s, 284–289 control in the 1990s, 289–301 SDWA requirements, 650, 748, 848 trihalomethanes, 13–14, 283 trade off with pathogen control, 289 Distillers, 414 Distribution systems contamination, 59, 65 early monitoring, 15 monitoring under Stage 2 Disinfectant Byproducts Rule (DBPR), 301 presence of coliform bacteria, 285 Dombrowski v. Gould Electronics, Inc., 549 Dose, toxic, 135 Dose-response assessment, 134, 186 Doublespeak, 204 Draft rules, in regulation development, 258 Drinking water advisories, 612 Drinking Water Contaminant Candidate List, see Contaminant Candidate List Drinking water coolers containing lead, 719, 850–851 Drinking water equivalent level (DWEL), 191 Drinking water quality lawsuits, 517 Drinking water standards, 583–619 Drinking water standards for regulated contaminants, 613–617

1014

INDEX

Drinking Water State Revolving Fund (DWSRF), 84, 450 funds, and conservative planning, 471 Drinking water studies, 716–718, 847–849 Drinking water vulnerability assessments, 125 Drinking water Federal Register notice listings, 953–969 Dual distribution system, historical use, 5 Dual-stage membrane filtration, 389 DWCCL, see Drinking Water Contaminant Candidate List DWEL, see Drinking water equivalent level DWSRF, see Drinking Water State Revolving Fund

E. coli, 61, 588. See also Escherichia coli 0157:H7, Escherichia coli 06:H16, and Escherichia coli 0121:H19 E. histolytica, 56 Earth Day, 113 Ecological studies, 158 Economies of scale, 458, 468 EDE, see Effective dose equivalent EDF, see Environmental Defense Fund Effective dose equivalent (EDE), 312 Effective dose, 140 Efficiency, 477 EJ, see Environmental justice Elderly individuals, see Sensitive subpopulations Emergency planning, 574 Emergency powers, 571–576 SDWA requirements, 684, 801–802 Emergency Preparedness and Response, Department of Homeland Security (DHS), 577 Emergency response plans, 125, 574 SDWA requirements, 687–688, 804–805 Emerging technologies, 384–386 Enactment of a law, see federal legislative process Endangered species, 126 Endemic disease, 32, 34 Endemic waterborne disease, 170 Endocrine disrupters, 125, 360 SDWA requirements, 716, 847 Energy Policy Act of 1992, 333–334 Enforcement authority, 125 by USEPA in 1980s, 82 SDWA requirements, 662–669, 757–761

underground injection programs (UIC), 681, 787–790 Enhanced coagulation, 296 Enhanced softening, 296 Enhanced Surface Water Treatment Rule, 717, 848 Enhanced waterborne disease surveillance, 38 Enteric disease, 25 Enteric pathogens, 25 Enteric viruses, 61 Enterovirus, 62 Environmental Defense Fund (EDF), 19, 76 Environmental epidemiologic studies, 148 Environmental equity, 515 Environmental finance centers, 680, 782 Environmental groups, 117, 120, 123 Environmental justice (EJ) analyzing, 525 benefit-cost analysis, 233 communities, 517–519 definition, 513, 515 history of, 513 identifying situations of, 517, 525 intergenerational equity, 521–524 proposed radon rule, 526–528 Environmental Law Institute, 516 Environmental lawmaking, 121 Environmental racism, 517 Environmental studies, potential errors in, 212 Environmental Technology Verification (ETV), 384 Environmental toxicology, 135 Epidemic versus endemic disease, 33 Epidemiology, 136, 149–150, 168, 178 Epidemiologic studies causality, 168–169 confounding bias, 165 effect modification, 166 errors, 163 experimental, 156 exposure-disease association, 168 in lawsuits, 541–542 interpreting, 163 measure of association, 167 meta analysis, 169 misclassification bias, 163 observational, 156 recall bias, 163 strength of association, 168 types of, 157 waterborne disease, 33, 292 Equity, 479

INDEX

Escherichia coli 0157:H7, 56, 62. See also E. coli Escherichia coli 06:H16, 56. See also E. coli Escherichia coli 0121:H19, 62. See also E. coli Estrogenic substances screening program, 716, 847 Etiologies of waterborne outbreaks, 54 ETV, see Environmental Technology Verification Euphemism, 204 Ex Parte communication in rulemaking, 260 Executive branch, 106 Executive Orders EO 12866, 263 EO 12898, 262, 516 EO 13166, 263 EO 13175, 262 Exemptions, 672, 771–774 Experimental design, 202 Expert judgment, 208, 363 Expert witnesses, 539 Exposure assessment, 134, 186 Exposure to chemicals, 136 Exposure-disease association in epidemiologic studies, 168

FACA, see Federal Advisory Committee Act Fair-mindedness, 206 Fallacies in reasoning, 207 Falsifiability, 202 FBI, see Federal Bureau of Investigation FBRR, see Filter Backwash Recycling Rule Feasible technologies, 652–653, 746–747. See also Best available technology Fecal coliforms, 63, 588 Federal Advisory Committee Act (FACA), 119, 261, 262, 343 Stage 1 D=DBPR advisory committee, 291, 294 recommendations on Interim Enhanced Surface Water Treatment Rule (IESWTR), 296 recommendations for Stage 2 Disinfection Byproduct Rule (DBPR), 300 recommendations for LT2ESWTR, 300 Federal agencies under the SDWA, 697–698, 823–825 Federal assistance, 668 Federal Bureau of Investigation (FBI), 568

1015

Federal guidance report (FGR) No. 13, 334–335 Federal legislative process, 108, 871–922, 923–951 Federal preemption, 550, 668 Federal Register notices, drinking water, 953–969 FESWTR, see Final Enhanced Surface Water Treatment Rule Fetuses, 523. See also Sensitive subpopulations FGR, see Federal Guidance Report No. 13 Filter backwash requirements, 659, 754 Filter Backwash Recycling Rule (FBRR), 299 Filter effluent turbidity under the IESWTR, 298 Filter monitoring under the IESWTR, 298 Filtration, 284, 655, 748–749 inadequate, 59–60 SDWA requirements, 655, 748–749 Final Enhanced Surface Water Treatment Rule (FESWTR), 650, 744 Financial capacity, 469. See also Sustainable water systems Financial resources, see Sustainable water systems Fluoride poisoning, 57 FOIA, see Freedom of Information Act Freedom of Information Act (FOIA), 572 Frye v. United States lawsuit, 539 Functional geonomics, 376 Funding. See also Sustainable water systems SDWA levels, 124 SDWA, growth of, 96 security, 125 water system security, 574

Gastroenteritis, 53, 63, 162, 170, 171, 494 Gastrointestinal illness, 292 Gene banks, 376 General acceptance in toxic torts, 539 General Accounting Office studies, 82 General provisions under SDWA, 700, 828–830 Genetic predisposition, 504 Genomics, 376 GFH, see Granular ferric hydroxide Giardia, 36, 56, 61, 62, 588 analytical method, 293 in swimming pools, 67 inactivation, 390 membrane removal, 388

1016

INDEX

Giardia (Continued ) removal requirements, 288–289 Giardiasis, 36, 35, 66 in Massachusetts, 154 lawsuits, 535 toxic torts, 550 Globalization, 127 Gobbledygook, 204 Government Performance and Results Act, 1003 Grants for state programs, 692, 813–816 Grants for special studies and demonstration projects, 692, 816–817 Granular ferric hydroxide (GFH), 385 Gross alpha, 315, 323 Ground water contamination, 66 disinfection, 66 Ground Water Disinfection Rule, 718, 848 Ground Water Rule (GWR), 300 inadequate treatment, 65 Ground water protection grants under the SDWA, 683–684, 800–801 Ground water softening, 389 Ground water systems, 999–1001 Ground Water Supply Survey, 115 GWR, see Ground water

HA, see Health advisory HAA5, see Haloacetic acids Half-life, 311 Haloacetic acids (HAA5), 301, 589 Hartwell Corp. v. Superior Court of Ventura County lawsuit, 551 Hazard characterization, 134 Hazard identification, 186 Hazardous materials, 525 Hazen, Allen, 9 Health advisory (HA), 143–144, 583–619 Health effects, 330 Health risk reduction and cost analysis (HRRCA), 189, 193, 226 SDWA requirements, 651–652, 744–746 Hemolytic uremic syndrome, 63 Hepatitis A virus, 56, 62 Hepatitis, 53 Heterotrophic plate count (HPC), 282, 405, 588 High-pressure membranes, 377, 388–389 Homeland security, 106 advisory system, 579 Homeland Security Act of 2002, 576–578

Host-agent-environment relationship, 151 House of Representatives, 106 Household intervention study, 34 HPC, see Heterotrophic plate count HRRCA, see Health risk reduction and cost analysis Human health risk assessment, 134 Hydrogeologic assessment, 66 Hyperendemic disease, 32 Hypothesis testing, 202 Hypotheticodeduction, 200

Iberville Parish Waterworks Dist. No. 3 v. Novartis Corp Protection, Inc., lawsuit, 552 ICR, see Information Collection Rule IESWTR, see Interim Enhanced Surface Water Treatment Rule Immunosuppressed persons, 40 Implementation of point-of-use=point-ofentry devices, 422–427 Impoverished minority communities, 513 Increasing-block rates, 475 Incremental benefits, 230 Incremental costs, 230 Indian tribes SDWA requirements, 701, 831 water system data, 1002 Indicator organisms, 278. See also Coliform bacteria Individual water systems, 48 Inductive reasoning, 200 Industrial Revolution, 6, 9 Industry restructuring, 458 Infants, see Sensitive subpopulations Infection monitoring, 36 Infections, 497 Infectious diseases, 5 cholera historical outbreaks, 7–9 cholera outbreak in Peru in 1991, 20 cholera outbreak in South Africa in 2001, 20 cryptosporidiosis outbreak in Milwaukee in 1993, 27 typhoid, 12–13 Inflated language, 205 Information Analysis and Infrastructure Protection, Department of Homeland Security (DHS), 577 Information Collection Rule (ICR), requirements, 293–294, 650, 744 Information Sharing and Analysis Center, 576

INDEX

Infrastructure, 126, 471, 578 Infringement of patent, 564–565 Inhalation reference concentration (RfC), 139 Inorganic chemicals, 590 Integrated membrane systems, 389 Intellectual property, 556 Intellectual property laws, see Patents Intergenerational equity, 480, 523, 521–524 Interim Enhanced Surface Water Treatment Rule (IESWTR), 296–299, 650, 744 International System (SI), 312 Interstate Quarantine Act of 1893, 14, 111 Ion exchange (IX), 393 Irreversible effects of chemicals, 135 IX, see Ion exchange Jargon, 204 Judicial branch, 106 Judicial challenge on chloroform, 219 Judicial review process overview, 215–216 SDWA requirements, 699, 825–826 Judicial standing, 216 Judicial system and science, 215 Judicial deference, 218 Junk science, 210 Keratitis, 63 Kidney toxicity, 246 Laboratory disease reporting, 30 Lake outbreaks, 62 Large system sustainability, 468 Law of noncontradiction, 200 Lawmaking, 107, 121 environmental, 121 incremental changes, 124 process, 871–951 Law enactment, see Legislation Lawsuits AlliedSignal, Inc. v. City of Phoenix, 552 Amchem Products v. Windsor, 545 arsenic, 552 asbestos exposure, 545 Bendectin, 542 benzene, 541 Castellow v. Chevron USA, 541 Chesapeake, Virginia, 534 chloroform, 219 City of Evansville v. Kentucky Liquid Recycling, Inc., 551

1017

City of Waukesha, v. EPA, 310, 322, 333, 335 class action, 544–547 Clean Air Act, 551 Clean Water Act, 551 Consumer Confidence Reports, 551 discovery, 547 drinking water quality, 517 environmental groups, 116–118, 120 environmental justice (EJ), 517, 529 epidemiologic studies, 541–542 Frye v. United States, 539 giardiasis, 535 Hartwell Corp. v. Superior Court of Ventura County, 551 herbicides, 552 Iberville Parish Waterworks Dist. No. 3 v. Novartis Corp Protection, Inc., 552 industrial pollutants, 517 Lofgren v. Motorola, 542 Markweise v. Peck, 550 Matton v. City of Pittsfield, 550 Merrell Dow Pharmaceuticals, Inc. v. Havner, 542 Oldham v. Louisiana, 552 process of, 543 radiation exposure, 545 Reilly v. Gould Inc., 546 review of radionuclide regulations in 2000, 310 Rutigliano v. Valley Business Forms, 541 science, 215 SDWA compliance not complete defense in lawsuits, 551 Thomas v. FAG Bearings Corp., 546 toxic torts, 534–535 trials, 548 Wright v. Willamette Industries, Inc., 541 Leaching of metals, 65 Lead contamination in drinking water coolers, 81, 719, 850–851 in school drinking water, 719–720, 851–852 SDWA requirements, 672, 774–776 Lead Contamination Control Act, 80 Lead poisoning, 58, 503 LED10, 140 Legionella, 289, 588 Legislation federal process, 108, 871–922, 923–951 floor action, 109 terrorism, 91, 95. See also Terrorism Leptospira, 53, 62–63

1018

INDEX

Liability in toxic torts, 536–538 Liability of point-of-use=point-of-entry devices, 424–425 Life years saved (LYS), 234 Lifeline rates, 475, 484 Lifespan, 494 Linear dose-response model, 139 Litigation, 534. See also Toxic torts Litigation and regulations, 217 Loans. See also Affordability and sustainable water systems Loans, guaranteed, SDWA requirements, 692–693, 816–817 Loans, state revolving funds, SDWA requirements, 701–710, 831–840 LOAEL, see Lowest-observed-adverse-effect level Lofgren v. Motorola lawsuit, 542 London, historical pollution, 7–10 Long Term 1 Enhanced Surface Water Treatment Rule (LT1ESWTR), requirements, 299 Long Term 2 Enhanced Surface Water Treatment Rule (LT2EWTR), 300, 396 Longitudinal study, 159 Lowest-observed-adverse-effect level (LOAEL), definition, 139 Low-income communities, 519 customers, 475 households, 479, 521 population, 515, 516, 517, 522, 523 Low-Income Home Energy Assistance Program, 471 Low-pressure membranes, 387, 388 LT2EWTR, see Long Term 2 Enhanced Surface Water Treatment Rule Long Term 2 Enhanced Surface Water Treatment Rule (LT2ESWTR), goals, 300 LYS, see Life years saved

Maintenance of point-of-use=point-of-entry devices, 420–422 Mandatory disinfection, 655–656, 750 Mandatory filtration, 655, 749 Margin of exposure (MoE), 143 Markup session, 109 Markweise v. Peck lawsuit, 550 Matton v. City of Pittsfield lawsuit, 550 Maximizing net benefits, 229

Maximum contaminant level goals (MCLGs), 119, 141–143, 330, 588–599 arsenic, 141 bromoform, 141 calculated from the oral reference dose (RfD), 142 development by USEPA, 189–192 health goal for carcinogens, 116 reference dose, 190 SDWA requirements, 652, 745 Maximum contaminant levels (MCLs), 119–120, 317, 588–599 relaxation of, 320 SDWA requirements, 652, 744–746 setting, and risk estimate, 322 setting for radionuclides, 315–317 Maximum residual disinfectant levels (MRDLs), 294, 590 MCLGs, see Maximum contaminant level goals MCLs, see Maximum contaminant levels Measures of association in epidemiologic studies, 167 MEGO, see My eyes glaze over. See also Consumer Confidence Reports Membrane treatment, 387–789 Merrell Dow Pharmaceuticals, Inc. v. Havner lawsuit, 542 Meta analysis, 169 Methyl tertiary butyl ether (MTBE), 612 MF, see Microfiltration Microbial contamination, 277. See also Waterborne pathogens Microbial drinking water standards, 1914 to 1962, 279 Microbial pathogens, emerging, 358 Microfiltration (MF), 387, 388 Millirem (mrem), definition, 312 Milwaukee, 27, 49, 55, 291, 442 Minority populations, 517, 522 Misclassification bias in epidemiologic studies, 163 MMM, see Multi-media mitigation MoE, see Margin of exposure Monitoring coliform, 67, 619 during outbreak 59 for intentional contaminant introduction, 575 frequencies, for final radionuclides regulations, 323 frequency for coliform bacteria, 619 infection, 36 point-of-use=point-of-entry devices, 422

INDEX

requirements, 117 SDWA requirements, 673–675, 776–778 unregulated contaminants, 345, 693–695, 818–819 Monopolies of water utilities, 478 Mortality, 155 Mrem, see Millirem MTBE, see Methyl tertiary butyl ether Multibarrier approach for pathogen control, 302 Multi-media mitigation (MMM), 526 Multimedia radon mitigation programs, SDWA requirements, 658–659, 753 My eyes glaze over (MEGO), 444

N. flowleri, see Naegleria flowleri Naegleria flowleri, 55, 61–62 Nanofiltration (NF), 387, 388 NAPA, see National Academy of Public Administration NAS, see National Academy of Sciences National Academy of Public Administration (NAPA), 522 National Academy of Sciences (NAS), 342–343 drinking water studies, 77–79 risk assessment paradigm, 134 National Drinking Water Advisory Council (NDWAC), 229, 343 beginning use of benefit-cost analysis, 229 Contaminant Candidate List (CCL), 343 regulatory decisionmaking protocols for Contaminant Candidate List (CCL), 354 Working Group on Contaminant Occurrence and Contaminant Selection, 343, 347, 350 SDWA requirements, 697, 822–823 National Drinking Water Contaminant Occurrence Database (NCOD), 344–345, 696, 821 National Environmental Justice Advisory Council, 516 National Infrastructure Protection Center, 568 National Infrastructure Simulation and Analysis Center (NISAC), 578 National Inorganics and Radionuclides Survey (NIRS), 331 National Interim Primary Drinking Water Regulations (NIPDWRs), 75, 80, 280 National Organics Monitoring Survey (NOMS), 75, 115, 283

1019

National Organics Reconnaissance Survey (NORS), 74, 75, 283 National Primary Drinking Water Regulations (NPDWRs), 583–619, 643–661, 741–755, 971–977 review of, 194, 656, 750 National Quarantine Act of 1878, 278 National Research Council (NRC), 342–343 National Science Foundation (NSF) international, 384, 408 verification testing with the USEPA, 384 National Screening Program for Organics (1977=1981), 115 National Secondary Drinking Water Contaminant Standards, see National Secondary Drinking Water Regulations National Secondary Drinking Water Regulations, 610, 618, 660, 667, 755, 977 National Secondary Regulations, see National Secondary Drinking Water Regulations National Water Contaminant Occurrence Database, 696, 821 National Water Information System (NWIS) of the U.S. Geological Survey (USGS), 345 Natural Resources Defense Council (NRDC), 85 Naumachia, 5 NCOD, see National Drinking Water Contaminant Occurrence Database NDWAC, see National Drinking Water Advisory Council Negotiated Rulemaking Act of 1990, 263 Negotiated rulemaking for disinfection byproducts (DBPs), 291 Nephelometric turbidity units (NTUs), see Turbidity Net alpha in radionuclides regulation, 323 Neural network, 372 New community water systems, 450 New system capacity demonstration, 450 New York City, 10, 26 NF, see Nanofiltration NIMBY, see Not in my backyard NIPDWRs, see National Interim Primary Drinking Water Regulations NIRS, see National Inorganics and Radionuclides Survey NISAC, see National Infrastructure Simulation and Analysis Center

1020

INDEX

NOAEL, see No-observed-adverse-effect level NODAs, see Notice of Data Availability NOMS, see National Organics Monitoring Survey Noncancer health risks, 192 Noncarcinogens, 142, 192 Noncommunity water system, 48, 65 Noncontradiction, 200 Non-sustainable systems, 473 Non-threshold effects, 135 Nontransient, noncommunity systems, 506–507 Nontransient, noncommunity water system inventory, 999–1001 No-observed-adverse-effect level (NOAEL), 139, 190 NORS, see National Organics Reconnaissance Survey Norwalk virus, 56 Norwalk-like virus, 62, 63 Not in my backyard (NIMBY), 123 Notice of Data Availability (NODAs), 219 Notification of intentional contamination, 575 NPDWRs, see National Primary Drinking Water Regulations NRC, see National Research Council NRDC, see Natural Resources Defense Council NSF, see National Science Foundation NDWAC, see National Drinking Water Advisory Council NTUs, see Nephelometric turbidity units NWIS, see National Water Information System

Objective reasoning, 202 Objectivity in science, 199 Occurrence database, SDWA requirements, 696, 821 Occurrence of infection, 31 Occurrence of uranium, 331 Office of Environmental Justice, 515 Office of Management and Budget (OMB), 109, 115 Office of Private Sector Liaison, Department of Homeland Security (DHS), 577 Office of State and Local Government Coordination, Department of Homeland Security (DHS), 577 Oldham v. Louisiana, lawsuit, 552

OMB, see Office of Management and Budget Operator certification, SDWA requirements, 675–677, 778–779 Optimization treatment, 396 Optional demonstration by states relating to oil or natural gas, SDWA requirements, 682, 791–792 Oral arguments, 217 Oral reference dose (RfD), 139, 330, 142 Organic chemicals, 593 Organic contaminants, 75, 588–599 Otitis externa, 53 Outbreaks. See also Pathogen control, Pathogens, Waterborne disease, and Waterborne pathogens actual reporting, 30 algae, 54 bacterial, 54 chemical, 54, 56 cholera, 7–9, 20 cryptosporidiosis, 27, 38, 49 deaths from, 55 detection, 31, 39 giardiasis, 35 ground water, 53 investigations, 34 protozoan, 54 recreational water, 51, 53, 61, 64, sampling during, 59 seasonal, 51 surface water, 53 trends, 49, 65 underreporting, 47 viral, 54 Walkerton, Canada, 497 water qualities, 59 Over reporting of symptoms, 32 Oxidation processes, advanced, 391–392 Ozone, 392 Ozone with hydrogen peroxide, 392–393

Parasite prevalence surveys, 36 Passive disease reporting, 28 Patents copyrights, 555 infringement, 564–565 obtaining, 563–534 patent definition, 555 patent law, 555, 556–536 patentability, 558–536 property, 555

INDEX

protection, 557 trademarks, 555 Pathogen control, 277– 302. See also Outbreaks, Pathogens, Waterborne disease, and Waterborne pathogens Pathogens, 284, 293, 497. See also Outbreaks, Pathogen control, Waterborne disease, and Waterborne pathogens PCB contamination, lawsuit, 540 PCCL, see Preliminary Contaminant Candidate List (PCCL). See also Contaminant Candidate List (CCL) Peer input, 206 Peer regard, 209 Peer review, 202, 206, 209 People of color, 515 Petition for judicial review, 216 Pharmaceuticals, 125 Pharyngitis, 53 Photon emitters, 311, 315 Picocurie, 312 Pilot testing of point-of-use=point-of-entry devices, 418 Plesiomonas shigelloides, 56 Plumbing leaching, 65 Pocket veto, 110 PoD, see Point of departure POE, see Point-of-entry. See also Point-ofuse and point-of-entry treatment devices Point of departure (PoD), 143 Point-of-entry devices (POE), 403 softeners, 415–417 Point-of-use and point-of-entry treatment devices administration, 423 ANSI=NSF standards, 409 arsenic removal, 427 certification, 408 contaminants effective for, 404 cost, 405, 420, 426–427 distillation system, 411 equipment reliability, 425 implementation, 422–427 installation, 420–422 liability, 424–425 maintenance, 420–422 monitoring, 422 operation, 420 operator training and certification, 424 pilot testing, 418 public relations, 423 rental, 405 residuals, 420

1021

reverse-osmosis (RO), 410 selecting, 417–420 state and local regulations, 419 technology, 404–405, 411–418 ultraviolet, 410 waste disposal, 420, 425–426 Point-of-use devices (POU), 403, 412–415. See also Point-of-use and point-of-entry treatment devices Poisoning, 57–58, 503 Pollutants and environmental justice (EJ), 219 Polluter pays, 123 Pools, see Swimming pools Postmodern science, 202 Potable, 71 POU, see Point-of-use devises. See also Point-of-use and point-of-entry treatment devices Poverty level, 522 Precautionary assumptions, 244 Pregnant women, 493. See also Sensitive subpopulations Preliminary Contaminant Candidate List (PCCL), 359. See also Contaminant Candidate List (CCL) Presidential bill approval, 916, 947 Presidential veto, 915–917, 947 Presuppositions, 205 Pricing of water, 463, 473. See also Sustainable water systems Pricing strategies, 486, 487 Pricing theory, 477–480 Primacy, 74, 661, 756–757 funding, 125 Prions, 497 Prioritization schemes, 351 Prioritize research and monitoring needs, 349 Process optimization, 396 Procurement process, 398 Promulgate, 280 Protection of endangered species, 126 Protection v. risk, 319 Protective immunity, 33 Prototype classification, 365, 368 Public, definition, 252 Public Health Protection and Bioterrorism Prevention and Response Act of 2002, 91, 122, 567, 570–576 Public Health Services standards, see U.S. Public Health Service standards Public information of health effects, SDWA requirements, 651, 744

1022

INDEX

Public involvement, 252–254, 259, 271 Public notification, SDWA requirements, 663–665 Public outreach, 440. See also Public relations Public policy application of sound science, 209 changes to, 124 conservative, 220 influence of science, 123 Public relations, 440–441, 423. See also Customers Public water system supervision (PWSS) national data, 1003 QALYs, see Quality-adjusted life years Quality-adjusted life years (QALYs), 234 Racial minorities, 515 Racism, 515 Radiation, 311–317, 545 Radioactive decay, 311 Radionuclide Rule compliance deadlines, 327 Radionuclides, 119, 597 best available technologies, 326. See also Feasible technologies definition, 311 long-term disposal of, 333 maximum containment levels (MCLs), 324 small system compliance technologies, 327 Radium, 315, 318, 328, 598 224 Ra, 328–329 226 Ra, 323, 598 228 Ra, 323, 598 Radon, 119, 232, 318 environmental justice (EJ) issues, 513, 525–528 multimedia mitigation programs, SDWA requirements, 658, 753 proposed rule, 513 SDWA requirements, 657–659, 751–754 Rads, see Radiation absorbed doses Randomized household intervention study, 34 Rate consolidation, 486 Rate design, 475, 481–484 Rate of disease, 32 Rate structure, 476, 482 Ratemaking, 479, 483 Real-time monitoring systems, 575

Reason and truth claims, 199 Rebuild America Coalition Infrastructure Survey, 441 Recall bias in epidemiologic studies, 163 Recall of drinking water coolers with leadlined tanks, SDWA requirements, 719, 850 Recommended maximum contaminant levels (RMCLs), 80 Records and inspections, SDWA requirements, 693, 817–818 Recreational water quality, 67 Recreational waterborne outbreaks, 64 Reference dose, 190. See also Oral reference dose Regionalization, 458 Reg-neg process, 266 Regulated contaminants, 81 Regulation development, 260 Regulation of state programs for class injection well, SDWA requirements, 682, 792–793 Regulations, early American, 14–17 Regulations, use of sound science, 214 Regulatory approval of new technologies, 386 Regulatory development process, 215 Regulatory Flexibility Act (RFA), 262 Regulatory negotiation, 266 Regulatory reform, 117, 118 Reilly v. Gould Inc. lawsuit, 546 Relative source contribution (RSC), 143, 191 Relativism, scientific, 203 Rems, see roentgen equivalent in man Replication in research, 202 Report language for legislation, 109 Reporting of actual outbreaks, 30 Research, 202, 349 SDWA requirements, 691–692, 809–813 Restructuring the water industry, 127 Retroduction, 199 Retrospective study, see Case-study Revenue, 482. See also Sustainable water systems Reverse-osmosis (RO), 387, 388, 412 Reversible effects, 135 Review of NPDWRs, 194, 656, 750 Revised National Drinking Water Regulations, 75 Revised Total Coliform Rule, 287 RFA, see Regulatory Flexibility Act RfC, see Inhalation reference concentration RfD, see Oral reference dose Rheumatoid arthritis, 502

INDEX

Risk assessment, 118, 124, 133, 137 acceptable risk levels, 192 approaches, 184 as regulations, 193 carcinogens, 191 dose-response assessment, 186 DWEL, 191 exposure assessment, 186 hazard identification, 186 in USEPA regulation process, 189 precautionary policy, 189, 191 risk characterization, 186 SDWA requirements, 650, 744 Risk characterization, 134 Risk communication, 309, 442 Risk reduction benefits, 233 Risk-risk tradeoff, 119 RMCLs, see Recommended maximum contaminant level RO, see Reverse-osmosis Roentgen equivalent in man (rems), 311, 312 Roman water supply, 4–5 Rotavirus, 56 Routes of exposure, 135 RSC, see Relative source contribution Rule-based methods, 364–354 Rulemaking, see Regulation development Rutigliano v. Valley Business Forms lawsuit, 541

Safe Drinking Water Information System (SDWIS), 345 Safe water, definition, 71 Salmonella, 56, 61–63 Sampling coliform bacteria, 281, 286 during outbreak, 59 for gross alpha, 325 for radium 226/228, 325 for uranium, 325 Sanitary engineering, 9 Sanitary surveys, 286, 299, 300, 454 Schistosoma dermatitis (swimmer’s itch), 61 Science Advisory Board, 265 Science application to public policy, 209 authority, 199 court challenges, 215 definition, 198 hypothesis testing, 202 influence on public policy, 123 limiting bias, 202

1023

objectivity, 199 postmodern, 202 reason and truth, 199 scientific relativism, 203 use in regulations, 214 Science Advisory Board review, SDWA requirements, 661, 755 Science and Technology, Department of Homeland Security (DHS), 577 Scientific disagreement, 209 Scientific method, 201 Screening criteria, 363 Safe Drinking Water Act (SDWA) of 1974, 73–75, 280 Safe Drinking Water Act (SDWA) amendments 1977–1980, 77 1986, 79, 114, 116, 645 1996, 81, 91, 318–319, 340–342, 645 SDWA best available technology (BAT), 382. See also Feasible technology and Best available technology SDWA compliance not complete defense in lawsuits, 551 technologies, 383–384 with point-of-use and point-of-entry treatment devices, 403 SDWA consideration of superfund cleanup costs, 332–334 SDWA coverage, 643, 740–741 SDWA definitions, 641–643, 738–740 SDWA drinking water standards, 583–619 SDWA emerging issues, 125 SDWA emerging technologies, 384 SDWA funding, 83, 96, 124–125 SDWA health advisories, 583–619 SDWA implementation, 82–85 SDWA mandated regulations, 341 SDWA National Drinking Water Regulations, see National Primary Drinking Water Regulations (NPDWRs) SDWA reauthorization 1986, 284 1994, 88 debate in 1995, 120 water system institutional weaknesses, 450 SDWA requirements administrative orders, 668 aquifer protections areas, 682, 793–797 arsenic, 656, 750–751. See also Arsenic availability of treatment chemicals, 690, 807–809 benefit-cost analysis, 654

1024

INDEX

SDWA requirements (Continued ) best available technology (BAT), 652–653, 746–747. See also Feasible technology and Best available technology capacity development, 677–680, 779–783 certification, operator, 675–677, 778–779 civil action, 662–663 civil action, citizen 699–700, 826–827 colonias, assistance to, 716, 846–847 conservation plans, 715–716, 846 consideration of sensitive subpopulations 491–493 consolidation inventive, 669 Consumer Confidence Reports, 666–667, 761 Contaminant Candidate List (CL), 648–650, 742 contaminant monitoring, 673–675, 776–778 Contaminant Occurrence Database, 696, 821 contaminant prevention, 688–689, 805–806 contamination, lead in school drinking water, 719–720, 851–852 coolers, drinking water, recall, lead-lined tanks, 719, 850 cost considerations, 654–655 definitions, 719, 738–740, 849–850 disinfectant and disinfectant byproducts, 650, 744, 750 drinking water coolers containing lead, 719, 850–851 drinking water studies, 716–718, 847–849 emergency power, 684, 801–802 emergency response plan, 687–688, 804–805 endocrine disruptors, 716, 847 enforcement of Underground Injection programs (UIC), 681, 787–790 enforcement, 662–669, 757–760 environmental finance centers, 680, 782–783 Estrogen Substances Screening program, 716, 847 exemptions, 672, 771–774 feasible technologies, 652–653, 746–747. See also Best available technology federal agencies, 697–698, 823–825 federal assistance, 668 federal assistance for state programs regarding lead contamination in school drinking water, 720, 852 federal preemption, 668

SDWA requirements (Continued ) filtration backwash, 659, 754 final Enhanced Surface Water Treatment Rule (ESWTR), 650, 744 for point-of-use and point-of-entry treatment devices, 407 general provisions, 700, 828–830 grants, 692, 813–817 grants, for special studies, and demonstration projects, 692–693, 816– 817 ground water protection grants, 683–684, 800–801 health risk reduction and cost analysis, 651–652, 744–746 heath risk consideration, 654, 747 heath risk reduction and cost consideration, 654–656, 748 Indian tribes, 701, 831 Information Collection Rule, 650, 744 Interim Enhanced Surface Water Treatment Rule (IESWTR), 650, 744 interim regulation of Underground Injection programs (UIC), 681–682, 790–791 judicial review, 699, 825–826 lead contamination, 672, 774–776 lead contamination in school drinking water, 719–720, 851–852 federal assistance, 720, 852 loans, guaranteed, 692–693, 816–817 loans, state revolving funds, 701–710, 831–840 mandatory disinfection, 655–656, 750 mandatory filtration, 655, 749 maximum containment level (MCL), 652, 744–746 maximum containment level goals (MCLGs), 652, 745–746 monitoring of contamination, 673–675, 776–778 monitoring of unregulated contaminants, 693–694, 818–819 multimedia radon mitigation programs, 658–659, 753 National Drinking Water Advisory Council (NDWAC), 697, 755, 822–823 national secondary drinking water regulations, 610, 618, 660, 667, 755, 977 National Water Contaminant Occurrence Database, 696, 821 occurrence database, 696, 821

INDEX

SDWA requirements (Continued ) operator certification, 675–677, 778–779 optional demonstration by states relating to oil or natural gas, 682, 791–792 outline of section-by-section summary, 636–641 outline of SDWA text as amended, 721–738 primacy, 661, 756–757 public information of health effects, 651, 744 public notification, 663–665 radon, 657–659, 751–754 recall of drinking water coolers with leadlined tanks, 719, 850 records and inspections, 693, 817–818 regulation of state programs for class injection wells, 682, 792–793 research, 691–692, 809–811 review of NPDWRs, 656, 750 risk assessment, 650, 744 Science Advisory Board review, 661, 755 sensitive subpopulations, 717, 847 Small Public Water Systems Technology Assistance Centers, 679–680, 782 small system variances, 669–672, 768 source water petition program, 711–715, 842–846 source water quality assessment, 710–711, 840–842 special study and demonstration project grants, 692–693, 816–817 Stage 1 Disinfectants and Disinfection Byproducts Rule, 650, 744 Stage 2 Disinfectants and Disinfection Byproducts Rule, 650, 744 state ground water protections grants, 683–684, 800–801 state primacy enforcement responsibility, 661–662, 756–757 state primacy enforcement responsibility for Underground Injection programs (UIC), 681, 785–787 state programs for Underground Injection Control programs (UIC), 680–682, 783–785 state programs to establish wellhead protection areas, 683, 797–800 state revolving loan funds (SRLF), 701–710, 831–840 studies, drinking water, 716–718, 847–849 sulfate, 656–657, 751 supply disruption prevention, 689–690, 806–807

1025

SDWA requirements (Continued ) Service Water Treatment Rule, 747 tampering with public water systems, 684–685, 802 technical assistance, 691–692, 811–813 technology assistance centers, 679–680, 782 terrorist and other intentional acts, 685, 802–807 training, 691–692, 809–813 treatment chemicals, 690, 807–809 treatment techniques, 655, 745 Underground Injection programs (UIC), 680–682, 783–793 unregulated contaminants, 648–650, 742–743 unregulated contaminants, monitoring, 693–695, 818–819 use of science, 650, 744 USEPA emergency powers, 684, 801–802 USEPA grants for state programs, 692, 813–816 variance technologies, 659–660, 754–755 variances, 669–672, 767–771 violation, 662 vulnerability assessments, 685–687, 802–804 water conservation plans, 715–716, 846 water system capacity, 677–680, 779–783 water systems security, 575 water systems, tampering, 684–685, 802 wellhead protected areas, state programs, 683, 797–800 SDWA section-by-section summary, 635–720 SDWIS, see Safe Drinking Water Information System SDWIS water system data, by state, 1000–1001 SDWRs, see National secondary drinking water regulations Seasonal water use, 479 SEB, see Staphylococcal enterotoxin B Secondary maximum containment levels (SMCLs), 610, 618. See also National secondary drinking water regulations Security advisory system, homeland security, 579 Security enhancements for USEPA funding, 574 Security funding, 125 Security issues, 121

1026

INDEX

Security, water systems, see Water system security Senate, 106 Sensitive subpopulations, 341, 422, 491–511, 519, 569, 717, 847 Serological epidemiologic studies, 37 surveillance, 38 survey, 31 tests, 39 Shigella, 56, 61, 62, 63 SI, see International System Sievert (Sv), 312 Silent service, 433 Simultaneous compliance, 395 Single tariff pricing, 476, 484, 486 Slip law, 110 Small System Technology Assistance Centers, 679–680, 782 Small systems, 457–458 compliance, 124, 327 compliance technologies, 383 funding, 574 no variances allowed, 385 sustainability, 467 variance technologies, 383 variances 383–385, 669–672, 768 Snow, Dr. John, 7–9, 201 SOCs, see Synthetic organic chemicals Sodium hydroxide, 57 Softening, 296, 392 Softening, point-of-entry devices, 415–417 Sound science, see Science Source water assessment, 66, 126 contamination, 66 early regulations, 17 ground water, number of systems, 999 history of, 5 monitoring for Cryptosporidium, 300 Source water petition program, 711–715, 842–846 Source water quality assessment, 710–711, 840–842 South Dakota capacity development tool, 979–994 Sovereign immunity, 549 Sporatic disease, 32 Spread of disease, 5 SRLF, see State revolving loan fund Small round structured viruses (SRSV), 56 Stage 1 Disinfectants and Disinfection Byproducts Rule (D=DBPR)

requirements, 294–296, 650, 744 Stage 2 Disinfection Byproducts Rule (DBPR) compliance calculation for TTHMS and HAA5, 301 goals, 300–301 SDWA requirements, 650, 744 Stakeholders, 214, 252, 258, 445. See also Customers Standard plate count, 282. See also Heterotrophic plate count Standing, judicial, 216 Staphylococcal enterotoxin B (SEB), 569 State capacity development strategies, 450 State development of affordability criteria, 470 State ground water protection grants, SDWA requirements, 683–684, 800–801 State primacy costs, 124 State primacy enforcement responsibility for Underground Injection programs (UIC), SDWA requirements, 681–682, 758–787 State primary enforcement responsibility, SDWA requirements, 661, 756–757 State programs for UIC programs, SDWA requirements, 680–682, 783–785 State programs to establish wellhead protection areas, SDWA requirements, 683, 797–800 State revolving loan funds (SRLF), SDWA requirements, 701–710, 831–840 State UIC program data, 1008 State water system data, 1000–1001 Statistical life, 234 Statistical significance ( p value), level of (CI), 163 Steroids, 502 Strength of association in epidemiologic studies, 168 Subchronic toxicity, 136 Subcommittees, congressional, 108 Subsidies, 463, 467, 476–477, 481. See also Affordability Sulfate, SDWA requirements, 656–657, 751 Superfund, 332–334, 538 Supply disruption prevention, SDWA requirements, 689–690, 806–807 Surface water systems by state, 999–1001 Surface Water Treatment Rule (SWTR), 286, 288–289 disinfection requirements, 290 for filtered systems, 290

INDEX

for unfiltered systems, 290 requirements for unfiltered systems, 289 turbidity limits, 289–290 Sustainability and affordability, 473–477 Sustainability, see Sustainable water systems Sustainable pricing, 481–483 Sustainable water systems, 463–469, 476. See also Affordability Sv, see Sievert Swarming attacks, 570 Swimmer’s itch see Schistosoma dermatitis Swimming pools, 62–67 SWTR, see Surface Water Treatment Rule Synthetic organic chemicals (SOCs), 13, 74

Takings, 118 Tampering with public water systems, SDWA requirements, 684–685, 802 Tampering, penalties for, 571 TCR, see Total Coliform Rule Technical assistance, SDWA requirements, 691–692, 811–813 Technology assistance centers, SDWA requirements, 679–680, 782 Technology selection for compliance, 396 Terrorism, 91, 95, 125, 567, 569, 575–576 Terrorist and other intentional acts, SDWA requirements, 685, 802–807 Thames River, historical pollution, 7–9 Thinking, critical, 205 Third-party consultation in SDWA regulatory development, 342 THMs, see Trihalomethanes Thomas v. FAG Bearings Corp., lawsuit, 546 Thorium decay chain, 228Ra, 328 Threats to public water systems, 568 Threshold effect, 135, 313 Time-series analyses, 161 Tobacco smoke, 150 TOC, see Total organic carbon Toddlers, see Sensitive subpopulations Toolbox of technologies under LT2ESWTR, 300 Total bacteria counts, 282. See also Heterotrophic plate count Total coliform, 588. See also Coliform bacteria monitoring frequency, 619 Total Coliform Rule (TCR) 1975, 281 1975, shortcomings, 285 revised in 1989, 285–287

1027

Total coliforms, 588. See also Coliform bacteria Total organic carbon (TOC), removal under Stage 1 Disinfectant Byproducts Rule (DBPR), 294–295 Total trihalomethanes (TTHMs), 283, 301, 589. See also Trihalomethanes Toxic chemical, 569 Toxic Substances Control Act (TSCA), 360 Toxic torts, 534–550 Toxicity data assessment, 137 Toxicology, 134 Trademarks, 555 Training, SDWA requirements, 691–692, 809–813 Transient non-community systems, 48, 507, 999–1001 Transplant recipients, see Sensitive subpopulations Transplantation, 500 Treasury Department standards of 1914, 278–279 Treatment chemicals, availability, SDWA requirements, 890, 807–809 Treatment optimization, 396 Treatment selection, 397–398 Treatment technique, 285, 288, 382 SDWA requirements, 655, 748–749 Treatment technology, 386, 397–398 Treatment, conflicting objectives, 395 Tribal water systems, 1002 Trihalomethanes (THMs), 74–77, 172, 283, 534. See also Total Trihalomethanes (TTHMs) True cost, see Sustainable water systems Truth, see Sound science TT, see Treatment technique TTHMs, see Total trihalomethanes Turbidity, 289, 296–297, 589 Two-stage membrane filtration, 389 Typhoid, 11, 13, 53

UCM, see Unregulated contaminant monitoring UF, see Ultrafiltration UF, see Uncertainty factor UIC, see Underground injection control program UL, see Underwriters Laboratories Ultrafiltration (UF), 387, 388 Ultraviolet (UV) disinfection, 301, 390–391, 414

1028

INDEX

UMRA, see Unfunded Mandates Reform Act of 1995 Uncertainty factors (UF), 139, 140, 330 in benefit-cost analysis, 243 in toxicology, 140 for uranium regulations, 330 Uncertainty in benefit-cost analysis, 242 Underground Injection Control program, 680–682, 783–758, 1008 Underwriters Laboratories (UL), 408 Unfunded federal mandates, 117 Unfunded Mandates Reform Act of 1995 (UMRA), 262 Unholy trinity, 118 United States Cost Guard, Department of Homeland Security (DHS), 577 United States Secret Service, Department of Homeland Security (DHS), 577 Unregulated Contaminant Monitoring (UCM) program, 344–345 Unregulated contaminant monitoring, SDWA requirements, 693–695, 818–819 Unregulated contaminants, 648–650, 742–743 Unreported waterborne disease, 284 Uranium, 317, 328–332, 598 Uranium toxicity, 246, 329 U.S. Environmental Protection Agency (USEPA), 46 U.S. General Accounting Office (USGO), 108 U.S. Geological Survey, 345. See also National Water Information System (NWIS) U.S. governmental structure, 105 U.S. Public Health Service (USPHS), 14, 111, 278–279 U.S. Public Health Service standards of 1962, full text, 621–633 USA Patriot Act, water system security, 578 Use of science, SDWA requirements, 650, 744 USEPA administrator, general authority under SDWA, 700, 828–830 USEPA Advance Notice of Proposed Rulemaking (ANPRM), 258 USEPA cancer classification categories, 138 USEPA drinking water standards, 613–617 USEPA emergency powers, 571 SDWA requirements, 684, 801–802 USEPA Grants for state programs, SDWA requirements, 692, 813–816

USEPA public involvement opportunities, 254 USEPA Science Advisory Board, see Science Advisory Board USEPA, see U.S. Environmental Protection Agency USEPA national level affordability threshold, 471–472 USEPA public involvement policy, 269 USGO, see U.S. General Accounting Office USGS, see U.S. Geological Survey USPHS, see U.S. Public Health Service USPHS Standards 1942 USPHS standards, 15 1962 USPHS standards, 16, 621 Utility assistance programs, 473 UV, see Ultraviolet disinfection

Vibrio cholerae, 56 Value of a statistical life (VSL), 236, 239 Variability in benefit-cost analysis, 242 Variance technologies, 383–385 SDWA requirements, 659–660, 754–755 Variances, 475 1996 SDWA amendments, 383 microbial contamination regulations, 384 regular variance, 383 SDWA requirements, 669–672, 767–771 small systems, 383 unavailable for Surface Water Treatment Rule (SWTR), 384 unavailable for TCR, 384 use of best available technology (BAT), 382 Veto, by President, 915–917, 947 VFARs, see Virulence factor-activity relationships Violations SDWA requirements, 662 health-based, number of water systems with, by state, 1000–1001 national data on, 1004–1007 Viral outbreaks, 54 Virulence factor-activity relationships (VFARs), 375 Viruses, 288, 388, 589 VSL, see Value of a statistical life Vulnerabilities, water system, 568 Vulnerability assessments, 125, 572 SDWA requirements, 685–687, 802–804

INDEX

Walkerton, Canada, outbreak, 497 WQA, see Water Quality Association Waste disposal point-of-use/point-of-entry devises, 420, 425–426 radioactive waste, 522 radionuclides, 333–334 site location, 518 Wastewater, 10, 126 Water conservation plans, SDWA requirements, 715–716, 846 conservation, 484 coolers containing lead, 81 demands due to population growth, 126 prices, 477 qualities in outbreaks, 59 recreation activities, 53 Water Quality Association (WAQ) Gold Seal Program, 408 Water rates, 471. See also Sustainable water systems Water systems capacity, 450–461, 472–473 capacity development tool example, 979–994 classification, 48 commonwealth data, 1002 consolidation, 458–461 cooperation, 460 economies of scale, 458 institutional weaknesses, 450 inventory data, by state, 1000–1001 mergers, 461 national violation data, 1004–1007 non-transient, non-community, number of, 999 number by state, 1000–1001 number of, 999 partnerships, 460 percentage meeting all health-based standards, 1003 regionalization, 458 security, 567–580 sustainability, 472–473, 521–524

1029

tampering, SDWA requirements, 684–685, 802 tampering penalties, 571 territory data, 1002 toxic torts, 549 transient, non-community, number of, 999 tribal system data, 1002 vulnerability, 568 with health-based violations, by state, 1000–1001 Waterborne agents, 570. See also Waterborne pathogens Waterborne disease. See also Disease, Outbreaks, and Waterborne pathogens illness, 53–55 occurrence study, 718, 848 outbreak surveillance system, 46 outbreaks, 45–68 surveillance systems, limitations, 28–31 unreported, 284 Waterborne illness, see Waterborne disease Waterborne outbreaks, see Outbreaks Waterborne pathogens. See also Outbreaks, Pathogen control, Pathogens, and Waterborne disease control before the 1970s, 277–280 control in the 1970s, 280–284 control in the 1980s, 284–289 control in the 1990s and beyond, 289–302 Watershed control program for Cryptosporidium under the Interim Enhanced Surface Water Treatment Rule (IESWTR), 297 Watershed control, 302 Weapons of mass destruction, 569 Wellhead protection areas, state programs, SDWA requirements, 683, 797–800 Willingness to pay (WTP), 235–236, 473, 471 Wright v. Willamette Industries, Inc., lawsuit, 541 WTP, see Willingness to pay Yersinia, 5 Yucca Mountain, 333–334, 336