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Classifying Drinking Water Contaminants for Regulatory Consideration Classifying Drinking Water Contaminants for Regulatory Consideration Committee on Drinking Water Contaminants Water Science and Technology Board Board on Environmental Studies and Toxicology Division on Earth and Life Studies National Research Council NATIONAL ACADEMY PRESS Washington, D.C. 2001
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Classifying Drinking Water Contaminants for Regulatory Consideration NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The members of the committee responsible for the report were chosen for their special competences and with regard for appropriate balance. Support for this project was provided by the U.S. Environmental Protection Agency under Grant No. X-826345-01-0. International Standard Book Number: 0-309-07408-8 Library of Congress Control Number: 2001093985 Classifying Drinking Water Contaminants for Regulatory Consideration is available from the National Academy Press, 2101 Constitution Avenue, N.W., Washington, D.C. 20418; (800) 624–6242 or (202) 334–3422 (in the Washington metropolitan area); Internet <http://www.nap.edu>. Copyright 2001 by the National Academy of Sciences. All rights reserved. Printed in the United States of America.
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Classifying Drinking Water Contaminants for Regulatory Consideration THE NATIONAL ACADEMIES Advisers to the Nation on Science, Engineering, and Medicine National Academy of Sciences National Academy of Engineering Institute of Medicine National Research Council The National Academy of Sciences is a private, nonprofit, self-perpetuating society of distinguished scholars engaged in scientific and engineering research, dedicated to the furtherance of science and technology and to their use for the general welfare. Upon the authority of the charter granted to it by the Congress in 1863, the Academy has a mandate that requires it to advise the federal government on scientific and technical matters. Dr. Bruce M.Alberts is president of the National Academy of Sciences. The National Academy of Engineering was established in 1964, under the charter of the National Academy of Sciences, as a parallel organization of outstanding engineers. It is autonomous in its administration and in the selection of its members, sharing with the National Academy of Sciences the responsibility for advising the federal government. The National Academy of Engineering also sponsors engineering programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievement of engineers. Dr. William A.Wulf is president of the National Academy of Engineering. The Institute of Medicine was established in 1970 by the National Academy of Sciences to secure the services of eminent members of appropriate professions in the examination of policy matters pertaining to the health of the public. The Institute acts under the responsibility given to the National Academy of Sciences by its congressional charter to be an adviser to the federal government and, upon its own initiative, to identify issues of medical care, research, and education. Dr. Kenneth I.Shine is president of the Institute of Medicine. The National Research Council was organized by the National Academy of Sciences in 1916 to associate the broad community of science and technology with the Academy’s purposes of furthering knowledge and advising the federal government. Functioning in accordance with general policies determined by the Academy, the Council has become the principal operating agency of both the National Academy of Sciences and the National Academy of Engineering in providing services to the government, the public, and the scientific and engineering communities. The Council is administered jointly by both Academies and the Institute of Medicine. Dr. Bruce M.Alberts and Dr. William A.Wulf are chairman and vice chairman, respectively, of the National Research Council.
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Classifying Drinking Water Contaminants for Regulatory Consideration COMMITTEE ON DRINKING WATER CONTAMINANTS DEBORAH L.SWACKHAMER, Chair, University of Minnesota, Minneapolis R.RHODES TRUSSELL, Vice Chair, Montgomery Watson, Inc., Pasadena, California FRANK J.BOVE, Agency for Toxic Substances and Disease Registry, Atlanta, Georgia LAWRENCE J.FISCHER, Michigan State University, East Lansing WALTER GIGER, Swiss Federal Institute for Environmental Science and Technology, Zurich JEFFREY K.GRIFFITHS, Tufts University, Boston, Massachusetts CHARLES N.HAAS, Drexel University, Philadelphia, Pennsylvania NANCY K.KIM, Center for Environmental Health, Albany, New York DAVID M.OZONOFF, Boston University, Massachusetts REBECCA T.PARKIN, The George Washington University, Washington, D.C. CATHERINE A.PETERS, Princeton University, New Jersey JOAN B.ROSE, University of South Florida, St. Petersburg PHILIP C.SINGER, University of North Carolina, Chapel Hill PAUL G.TRATNYEK, Oregon Graduate Institute of Science and Technology, Portland Staff MARK C.GIBSON, Study Director ELLEN A.DE GUZMAN, Senior Project Assistant
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Classifying Drinking Water Contaminants for Regulatory Consideration WATER SCIENCE AND TECHNOLOGY BOARD HENRY J.VAUX, JR., Chair, Division of Agriculture and Natural Resources, University of California, Oakland RICHARD G.LUTHY, Vice Chair, Stanford University, California RICHELLE M.ALLEN-KING, Washington State University, Pullman GREGORY B.BAECHER, University of Maryland, College Park JOHN BRISCOE, The World Bank, Washington, D.C. EFI FOUFOULA-GEORGIOU, University of Minnesota, Minneapolis STEVEN P.GLOSS, University of Wyoming, Laramie WILLIAM A.JURY, University of California, Riverside GARY S.LOGSDON, Black & Veatch, Cincinnati, Ohio DIANE M.MCKNIGHT, University of Colorado, Boulder JOHN W.MORRIS, J.W.Morris Ltd., Arlington, Virginia PHILIP A.PALMER (Retired), E.I.du Pont de Nemours & Co., Wilmington, Delaware REBECCA T.PARKIN, George Washington University, Washington, D.C. RUTHERFORD H.PLATT, University of Massachusetts, Amherst JOAN B.ROSE, University of South Florida, St. Petersburg JERALD L.SCHNOOR, University of Iowa, Iowa City R.RHODES TRUSSELL, Montgomery Watson, Pasadena, California Staff STEPHEN D.PARKER, Director LAURA J.EHLERS, Senior Staff Officer JEFFREY W.JACOBS, Senior Staff Officer MARK C.GIBSON, Staff Officer WILLIAM S.LOGAN, Staff Officer M.JEANNE AQUILINO, Administrative Associate PATRICIA A.JONES KERSHAW, Staff Associate ANITA A.HALL, Administrative Assistant ELLEN A.DE GUZMAN, Senior Project Assistant ANIKE L.JOHNSON, Project Assistant
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Classifying Drinking Water Contaminants for Regulatory Consideration BOARD ON ENVIRONMENTAL STUDIES AND TOXICOLOGY GORDON ORIANS, Chair, University of Washington, Seattle JOHN DOULL, Vice Chair, The University of Kansas Medical Center, Kansas City DAVID ALLEN, University of Texas, Austin INGRID C.BURKE, Colorado State University, Fort Collins THOMAS BURKE, Johns Hopkins University, Baltimore, Maryland GLEN R.CASS, Georgia Institute of Technology, Atlanta WILLIAM L.CHAMEIDES, Georgia Institute of Technology, Atlanta CHRISTOPHER B.FIELD, Carnegie Institution of Washington, Stanford, California JOHN GERHART, University of California, Berkeley J.PAUL GILMAN, Celera Genomics, Rockville, Maryland DANIEL S.GREENBAUM, Health Effects Institute, Cambridge, Massachusetts BRUCE D.HAMMOCK, University of California, Davis ROGENE HENDERSON, Lovelace Respiratory Research Institute, Albuquerque, New Mexico CAROL HENRY, American Chemistry Council, Arlington, Virginia ROBERT HUGGETT, Michigan State University, East Lansing JAMES FREDERICK KITCHELL, University of Wisconsin, Madison DANIEL KREWSKI, University of Ottawa, Ontario, Canada JAMES A.MacMAHON, Utah State University, Logan CHARLES O’MELIA, Johns Hopkins University, Baltimore, Maryland WILLEM FREDERIK PASSCHIER, Health Council of the Netherlands, The Hague ANN POWERS, Paco University, School of Law, White Plains, New York KIRK SMITH, University of California, Berkeley TERRY F.YOSIE, American Chemistry Council, Arlington, Virginia Staff JAMES J.REISA, Director DAVID J.POLICANSKY, Associate Director and Senior Program Director for Applied Ecology RAYMOND WASSEL, Senior Program Director for Environmental Sciences and Engineering KULBIR BAKSHI, Program Director for Committee on Toxicology ROBERTA WEDGE, Program Director for Risk Analysis K.JOHN HOLMES, Senior Staff Officer
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Classifying Drinking Water Contaminants for Regulatory Consideration Preface Most people would agree that protecting our drinking water supply by regulating the maximum allowable content of hazardous contaminants is desirable. What is of considerable debate is which contaminants should be regulated, how many should be regulated, and what process will be used to select them. The U.S. Environmental Protection Agency (EPA) currently has enforceable National Primary Drinking Water Regulations for more than 80 inorganic and organic chemical, radionuclide, and microbial contaminants and groups of related contaminants under the Safe Drinking Water Act (SDWA). The 1996 SDWA Amendments were intended to further this protective approach by requiring EPA to periodically develop a list of contaminants that are currently unregulated and may pose a health risk. The agency must then select from each list—called the Drinking Water Contaminant Candidate List, or CCL—at least five contaminants for regulatory decisions every five years. In addition to supporting the mandated development of drinking water regulations, each CCL is intended to be the source of priority contaminants for the EPA’s drinking water program as a whole and, to include research, monitoring, and guidance development. However, the specifics of developing the CCL and the manner in which the five or more contaminants are ultimately selected for regulatory decisions are not specified in the legislation. The EPA requested assistance from the National Research Council (NRC) in addressing these difficult issues. This project has been conducted in two phases. The first phase was completed in July 1999 and resulted in two reports. The first of these, Setting Priorities for Drinking Water Contaminants, examines past approaches used by federal agencies, state and local governments, public water utilities, and other organizations for establishing priorities among drinking water contaminants and other environmental pollutants. It also recommends a phased deci-
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Classifying Drinking Water Contaminants for Regulatory Consideration sion process, associated time line, and related criteria to assist EPA efforts to set priorities and decide which contaminants already on a CCL should be subjected to regulation development, increased monitoring, or additional research. The NRC also convened a workshop on “emerging” drinking water contaminants and published the proceedings in a second report entitled Identifying Future Drinking Water Contaminants. Preceding a dozen papers presented by government, academic, and industry scientists at the workshop is a short committee report that outlines a conceptual approach to the creation of future CCLs. In that report, the committee strongly urged EPA to consider the benefits of a more carefully considered and detailed description of the requirements of a CCL development process, especially regarding the identification of critical drinking water contaminants for regulatory activities from among tens of thousands of potential candidates. The second phase of the study focused on refining specific methods and processes to identify and narrow a very broad universe of potential contaminants into a smaller, more focused list for planning and action by interested parties. The specific tasks of the second phase are as follows: Identify and evaluate a process to narrow, focus, and prioritize contaminants from a preliminary list for inclusion on a smaller, more manageable list of contaminants, including chemical and microbiological contaminants. The process and methods will include simple (semi) quantitative tools to cull the broad preliminary list of contaminants. The tools that are developed to narrow and focus future drinking water contaminant lists will be tested using validation case examples of currently regulated contaminants. Explore the feasibility of developing virulence-activity relationships (VARs, now termed virulence-factor activity relationships or VFARs) for microbial contaminants. If a scientifically sound basis for developing VFARs is determined to be feasible, the committee will provide initial guidance and recommendations for interested parties on the steps necessary to construct and use VFARs. Time and resources permitting, the committee will provide specific recommendations of methods for narrowing the broadest universe of contaminants to a smaller, preliminary contaminant list. The Committee on Drinking Water Contaminants of the NRC addresses these three issues in the following report. We have recommended what may be considered a bold and innovative approach to selecting contaminants for inclusion on future CCLs. In our second report,
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Classifying Drinking Water Contaminants for Regulatory Consideration we recommended that the CCL be developed in a two-step process. Initially, the “universe” of potential drinking water contaminants is identified by considering many possible categories and sources of contaminants. A preliminary CCL, or PCCL, is culled by a screening process and expert judgment from this universe. Then the CCL is selected from the PCCL using a more refined process in conjunction with expert judgment. In this report, we provide initial guidance and several recommendations for how to accomplish the first step in this process. However, the bulk of the committee’s effort for this final report was focused on providing a detailed paradigm for selection of the CCL from the PCCL. To this end, we have recommend that EPA develop and use a set of selected contaminant attributes to evaluate the likelihood that a contaminant or group of related contaminants would occur in drinking water at sufficient concentrations or prevalence to pose a public health risk. To make this determination, we recommend that the agency use a prototype classification algorithm in conjunction with expert judgment. Although this approach requires considerable initial investment by EPA, we feel that it represents a superior approach to relying exclusively on expert judgment or ranking schemes such as those reviewed in our first report. The committee has gone so far as to develop a demonstration algorithm to test the efficacy of this approach, and the results are compelling. Last but not least, the committee concludes that the construction and eventual use of VFARs within EPA’s drinking water program is indeed feasible and merits careful consideration. We also provide some initial guidance and recommendations for their application herein. The committee is grateful for the support of this project by Michael Osinski and his colleagues at EPA’s Office of Ground Water and Drinking Water. In addition, we would not have been successful in our endeavors without the contributions of several experts who gave presentations to us during our first two meetings and aided in focusing our discussions. They include Fred Hauchman, EPA Office of Research and Development; Robert Clark, EPA Office of Research and Development; Kenneth Beattie, Oak Ridge National Laboratory; and Betty Olson, University of California at Irvine. We have been highly fortunate as a committee to have the significant contributions and guidance of Mark Gibson, study director of this project and staff officer in the NRC’s Water Science and Technology Board, and Carol Maczka, former program director for toxicology and risk assessment of the NRC’s Board on Environmental Studies and Toxicology.
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Classifying Drinking Water Contaminants for Regulatory Consideration Ellen de Guzman, senior project assistant in the Water Science and Technology Board, provided excellent staff support throughout the second phase of this study. The commitment shown by the NRC staff helped keep the study on time and make it a success. This report has been reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise in accordance with procedures approved by the NRC’s Report Review Committee. The purpose of this independent review is to provide candid and critical comments that will assist the institution in making its published report as sound as possible and to ensure that the report meets institutional standards for objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the deliberative process. We wish to thank the following individuals for their review of this report: David Acheson, Tufts University; Caron Chess, Rutgers University; Gunther Craun, Gunther F. Craun and Associates; Joseph Delfino, University of Florida; Lynn Franklin, Pacific Northwest National Laboratory; Erik Olson, National Resources Defense Council; and, Fred Pontius, Pontius Water Consult-ants, Inc. Although the reviewers listed above have provided many constructive comments and suggestions, they were not asked to endorse the conclusions or recommendations nor did they see the final draft of the report before its release. The review of this report was overseen by Michael Kavanaugh, Malcolm Pirnie, Inc., and Frank Stillinger, Bell Laboratories, Lucent Technologies. Appointed by the National Research Council, they were responsible for making certain that an independent examination of this report was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of this report rests entirely with the authoring committee and the institution. I would also like to thank three former members of this committee for their past insights and contributions, many of which carried over into this report: Branden Johnson, New Jersey Department of Environmental Protection, Trenton; Michael McGuire, McGuire Environmental Consultants, Inc., Santa Monica, California; and, Warren Muir, NRC. Finally, I thank the 13 members of this extraordinary committee. Each one brought a unique talent and exceptional degree of commitment
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Classifying Drinking Water Contaminants for Regulatory Consideration to the tasks at hand. The diversity of perspectives made for enlivened and enlightening discussion throughout and ultimately led us to the forward-looking recommendations contained herein. I was honored to be part of it all. DEBORAH L.SWACKHAMER Chair, Committee on Drinking Water Contaminants
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Classifying Drinking Water Contaminants for Regulatory Consideration Contents Executive Summary, 1 1 DRINKING WATER CONTAMINANT CANDIDATE LIST: PAST, PRESENT, AND FUTURE, 20 Introduction, 20 Development of the 1998 CCL, 24 Implementation Status of the 1998 CCL, 29 Limitations of the First CCL Development Process, 35 Related SDWA Programs, 36 Identifying and Selecting Contaminants for Future CCLs, 42 Perspective of This Report, 44 2 SOCIOPOLITICAL CONSIDERATIONS FOR DEVELOPING FUTURE CCLs, 45 Introduction, 45 Limitations of the First CCL Development Process, 45 Use of Sound Science in Future Regulatory Decisions, 49 Nature of the Task, 50 Risk Perception, 53 Protection of Vulnerable Subpopulations, 57 Transparency and Public Participation, 60 Summary: Conclusions and Recommendations, 69 3 THE UNIVERSE OF POTENTIAL CONTAMINANTS TO THE PRELIMINARY CCL, 71 Introduction, 71 Two-Step Approach, 71 The Universe of Potential Drinking Water Contaminants, 73 Distinguishing the PCCL from the Universe, 81 Guidelines for Developing Screening Criteria, 85 Fate of the PCCL, 88 Summary: Conclusions and Recommendations, 89
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Classifying Drinking Water Contaminants for Regulatory Consideration 4 PCCL TO CCL: ATTRIBUTES OF CONTAMINANTS, 93 Introduction, 93 Overview of Contaminant Attributes, 93 Lessons Learned in Applying These Criteria, 102 Summary: Conclusions and Recommendations, 105 5 PCCL TO CCL: CLASSIFICATION ALGORITHM, 107 Introduction, 107 Overview of Classification Schemes, 108 Illustrative Example of a Prototype Classification Scheme for CCL Contaminants, 115 Demonstrated Use of the Trained Classifier, 136 Summary: Conclusions and Recommendations, 139 6 VIRULENCE-FACTOR ACTIVITY RELATIONSHIPS, 143 Introduction, 143 Statement of the Problem, 145 VFAR Analogy to SARs and Quantitative SARs, 146 Framework, 147 Formulating VFARs, 148 Current Level of Genetic Characterization, 152 Virulence and Potency Response—Health Aspects, 163 Persistence Responses, 171 Interpretation of Issues, 179 Feasibility, 180 Conclusions and Recommendations, 184 References, 186 Acronyms and Abbreviations, 208 Appendixes A The European Prioritization Schemes “COMMPS” and “DYNAMEC,” 211 B Matlab Programs for Contaminant Classification, 223 C Biographical Information, 234