Strengthening Science at the U.S. Environmental Protection Agency

Research-Management and Peer-Review Practices

Committee on Research and Peer Review in EPA

Board on Environmental Studies and Toxicology

Commission on Geosciences, Environment, and Resources

Commission on Life Sciences

National Research Council

NATIONAL ACADEMY PRESS
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Strengthening Science at the U.S. Environmental Protection Agency: Research-Management and Peer-Review Practices Strengthening Science at the U.S. Environmental Protection Agency Research-Management and Peer-Review Practices Committee on Research and Peer Review in EPA Board on Environmental Studies and Toxicology Commission on Geosciences, Environment, and Resources Commission on Life Sciences National Research Council NATIONAL ACADEMY PRESS Washington, D.C.

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Strengthening Science at the U.S. Environmental Protection Agency: Research-Management and Peer-Review Practices NATIONAL ACADEMY PRESS 2101 Constitution Ave., N.W.Washington, D.C.20418 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. This project was supported by Contract No. 68-W4-0044 between the National Academy of Sciences and the U.S. Environmental Protection Agency and by endowment funds of the National Academy of Sciences. Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the author(s) and do not necessarily reflect the views of the U.S. Environmental Protection Agency. International Standard Book Number 0-309-07127-5 Additional copies of this report are available from: National Academy Press 2101 Constitution Ave., NWBox 285Washington, DC 20055 800-624-6242 202-334-3313 (in the Washington metropolitan area) http://www.nap.edu Copyright 2000 by the National Academy of Sciences. All rights reserved. Printed in the United States of America

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Strengthening Science at the U.S. Environmental Protection Agency: Research-Management and Peer-Review Practices THE NATIONAL ACADEMIES 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 achievements 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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Strengthening Science at the U.S. Environmental Protection Agency: Research-Management and Peer-Review Practices COMMITTEE ON RESEARCH AND PEER REVIEW IN EPA PAUL G. RISSER (Chair), Oregon State University, Corvallis JULIAN B. ANDELMAN, University of Pittsburgh, Pittsburgh ANDERS W. ANDREN, Univeristy of Wisconsin, Madison JOHN C. BAILAR III, University of Chicago, Chicago EULA BINGHAM, University of Cincinnati Medical Center, Cincinnati DAVID S. C. CHU, RAND, Washington, D.C. WALTER F. DABBERDT, National Center for Atmospheric Research, Boulder, Colo. ROLF HARTUNG, University of Michigan, Ann Arbor MORTON LIPPMANN, New York University Medical School, Tuxedo RAYMOND C. LOEHR, University of Texas, Austin JUDITH MCDOWELL, Woods Hole Oceanographic Institute, Woods Hole, Mass. DAVID L. MORRISON, North Carolina State University, Raleigh GEOFFREY PLACE, (retired: formerly Procter & Gamble), Hilton Head, S.C. BAILUS WALKER, JR., Howard University College of Medicine, Washington, D.C. Project Staff JAMES J. REISA, Principal Staff Officer RUTH E. CROSSGROVE, Editor JAMIE YOUNG, Research Associate MILLICENT ANDERSON, Assistant to the Director PAMELA FRIEDMAN, Program Assistant

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Strengthening Science at the U.S. Environmental Protection Agency: Research-Management and Peer-Review Practices BOARD ON ENVIRONMENTAL STUDIES AND TOXICOLOGY GORDON ORIANS (Chair), University of Washington, Seattle DONALD MATTISON (Vice Chair), March of Dimes, White Plains, N.Y. DAVID ALLEN , University of Texas, Austin I NGRID C. BURKE , Colorado State University, Fort Collins, Colo. WILLIAM L. CHAMEIDES , Georgia Institute of Technology, Atlanta, Ga. JOHN DOULL , The University of Kansas Medical Center, Kansas City CHRISTOPHER B. FIELD , Carnegie Institute of Washington, Stanford, Calif. JOHN GERHART , University of California, Berkeley J. PAUL GILMAN , Celera Genomics, Rockville, Md. BRUCE D. HAMMOCK , University of California, Davis MARK HARWELL , University of Miami, Miami, Fla. ROGENE HENDERSON , Lovelace Respiratory Research Institute, Albuquerque, N.M. CAROL HENRY , Chemical Manufacturers Association, Arlington, Va. BARBARA HULKA , University of North Carolina, Chapel Hill JAMES F. KITCHELL , University of Wisconsin, Madison DANIEL KREWSKI , University of Ottawa, Ottawa, Ont. JAMES A. MACMAHON , Utah State University, Logan MARIO J. MOLINA , Massachusetts Institute of Technology, Cambridge CHARLES O'MELIA, Johns Hopkins University, Baltimore, Md. WILLEM F. PASSCHIER, Health Council of the Netherlands KIRK SMITH, University of California, Berkeley MARGARET STRAND, Oppenheimer Wolff Donnelly & Bayh, LLP, Washington, D.C. TERRY F. YOSIE, Chemical Manufacturers Association, Arlington, Va. Senior Staff JAMES J. REISA, Director DAVID J. POLICANSKY, Associate Director and Senior Program Director for Applied Ecology CAROL A. MACZKA, Senior Program Director for Toxicology and Risk Assessment RAYMOND A. WASSEL , Senior Program Director for Environmental Sciences and Engineering KULBIR BAKSHI, Program Director for the Committee on Toxicology LEE R. PAULSON, Program Director for Resource Management ROBERTA M. WEDGE , Program Director for Risk Analysis

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Strengthening Science at the U.S. Environmental Protection Agency: Research-Management and Peer-Review Practices COMMISSION ON GEOSCIENCES, ENVIRONMENT, AND RESOURCES GEORGE M. HORNBERGER (Chair), University of Virginia, Charlottesville RICHARD A. CONWAY, Union Carbide Corporation (Retired), S. Charleston, W.Va. LYNN GOLDMAN, Johns Hopkins School of Hygiene and Public Health, Baltimore, Md. THOMAS E. GRAEDEL, Yale University, New Haven, Conn. THOMAS J. GRAFF, Environmental Defense, Oakland, Calif. EUGENIA KALNAY, University of Maryland, College Park DEBRA KNOPMAN, Progressive Policy Institute, Washington, D.C. BRAD MOONEY, J. Brad Mooney Associates, Ltd., Arlington, Va. HUGH C. MORRIS, El Dorado Gold Corporation, Vancouver, B.C. H. RONALD PULLIAM, University of Georgia, Athens MILTON RUSSELL, Joint Institute for Energy and Environment and University of Tennessee (Emeritus), Knoxville ROBERT J. SERAFIN, National Center for Atmospheric Research, Boulder, Colo. ANDREW R. SOLOW, Woods Hole Oceanographic Institution, Woods Hole, Mass. E-AN ZEN, University of Maryland, College Park MARY LOU ZOBACK, U.S. Geological Survey, Menlo Park, Calif. Staff ROBERT M. HAMILTON, Executive Director GREGORY H. SYMMES, Associate Executive Director JEANETTE SPOON, Administrative and Financial Officer DAVID FEARY, Scientific Reports Officer SANDI FITZPATRICK, Administrative Associate MARQUITA SMITH, Administrative Assistant/Technology Analyst

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Strengthening Science at the U.S. Environmental Protection Agency: Research-Management and Peer-Review Practices COMMISSION ON LIFE SCIENCES MICHAEL T. CLEGG (Chair), University of California, Riverside, Calif. PAUL BERG (Vice Chair), Stanford University, Stanford, Calif. FREDERICK R. ANDERSON, Cadwalader, Wickersham & Taft, Washington, D.C. JOHN C. BAILAR III, University of Chicago, Chicago, Ill. JOANNA BURGER, Rutgers University, Piscataway, N.J. SHARON L. DUNWOODY, University of Wisconsin, Madison DAVID EISENBERG, University of California, Los Angeles JOHN EMMERSON, Fishers, Ind. NEAL FIRST, University of Wisconsin, Madison DAVID J. GALAS, Keck Graduate Institute of Applied Life Science, Claremont, Calif. DAVID V. GOEDDEL, Tularik, Inc., South San Francisco, Calif. ARTURO GOMEZ-POMPA, University of California, Riverside COREY S. GOODMAN, University of California, Berkeley HENRY HEIKKINEN, University of Northern Colorado, Greeley BARBARA S. HULKA, University of North Carolina, Chapel Hill HANS J. KENDE, Michigan State University, East Lansing CYNTHIA KENYON, University of California, San Francisco MARGARET G. KIDWELL, University of Arizona, Tucson BRUCE R. LEVIN, Emory University, Atlanta, Ga. OLGA F. LINARES, Smithsonian Tropical Research Institute, Miami, Fla. DAVID LIVINGSTON, Dana-Farber Cancer Institute, Boston, Mass. DONALD R. MATTISON, March of Dimes, White Plains, New York ELLIOT M. MEYEROWITZ, California Institute of Technology, Pasadena ROBERT T. PAINE, University of Washington, Seattle RONALD R. SEDEROFF, North Carolina State University, Raleigh ROBERT R. SOKAL, State University of New York, Stony Brook CHARLES F. STEVENS, The Salk Institute, La Jolla, Calif. SHIRLEY M. TILGHMAN, Princeton University, Princeton, N.J. JOHN L. VANDEBERG, Southwest Foundation for Biomedical Research, San Antonio, Tex. RAYMOND L. WHITE, University of Utah, Salt Lake City Staff WARREN R. MUIR, Executive Director JACQUELINE K. PRINCE, Financial Officer BARBARA B. SMITH, Administrative Associate LAURA T. HOLLIDAY, Senior Program Assistant

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Strengthening Science at the U.S. Environmental Protection Agency: Research-Management and Peer-Review Practices OTHER REPORTS OF THE BOARD ON ENVIRONMENTAL STUDIES AND TOXICOLOGY Scientific Frontiers in Developmental Toxicology and Risk Assessment (2000) Modeling Mobile-Source Emissions (2000) Copper in Drinking Water (2000) Ecological Indicators for the Nation (2000) Waste Incineration and Public Health (1999) Hormonally Active Agents in the Environment (1999) Research Priorities for Airborne Particulate Matter: I. Immediate Priorities and a Long-Range Research Portfolio (1998); II. Evaluating Research Progress and Updating the Portfolio (1999) Ozone-Forming Potential of Reformulated Gasoline (1999) Risk-Based Waste Classification in California (1999) Arsenic in Drinking Water (1999) Brucellosis in the Greater Yellowstone Area (1998) The National Research Council's Committee on Toxicology: The First 50 Years (1997) Toxicologic Assessment of the Army's Zinc Cadmium Sulfide Dispersion Tests (1997) Carcinogens and Anticarcinogens in the Human Diet (1996) Upstream: Salmon and Society in the Pacific Northwest (1996) Science and the Endangered Species Act (1995) Wetlands: Characteristics and Boundaries (1995) Biologic Markers (5 reports, 1989-1995) Review of EPA's Environmental Monitoring and Assessment Program (3 reports, 1994-1995) Science and Judgment in Risk Assessment (1994) Ranking Hazardous Waste Sites for Remedial Action (1994) Pesticides in the Diets of Infants and Children (1993) Issues in Risk Assessment (1993) Setting Priorities for Land Conservation (1993) Protecting Visibility in National Parks and Wilderness Areas (1993) Dolphins and the Tuna Industry (1992) Hazardous Materials on the Public Lands (1992) Science and the National Parks (1992) Animals as Sentinels of Environmental Health Hazards (1991) Assessment of the U.S. Outer Continental Shelf Environmental Studies Program, Vol. I-IV (1991-1993) Human Exposure Assessment for Airborne Pollutants (1991) Monitoring Human Tissues for Toxic Substances (1991) Rethinking the Ozone Problem in Urban and Regional Air Pollution (1991) Decline of the Sea Turtles (1990) Copies of these reports may be ordered from the National Academy Press (800) 624-6242 or (202) 334-3313 www.nap.edu

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Strengthening Science at the U.S. Environmental Protection Agency: Research-Management and Peer-Review Practices Preface IN the three decades since the U.S. Environmental Protection Agency (EPA) was created, the agency's scientific and technical practices and credibility have been independently assessed many times in reports from the National Research Council (NRC), EPA Science Advisory Board, General Accounting Office, and many other organizations; in congressional oversight and judicial proceedings; and in countless criticisms and lawsuits from stakeholders with interests in particular EPA regulatory decisions. As a previous independent panel put it in the 1992 report Safeguarding the Future: Credible Science, Credible Decisions, EPA's policy and regulatory work receives a great deal of public attention, but the agency's scientific performance typically receives a similar degree of attention only when the scientific basis for a decision is questioned. Thus, strong scientific performance is important not only to enable EPA to make informed and effective decisions, but also to gain credibility and public support for the environmental protection efforts of EPA and the nation. This report is the fourth and final one in a series prepared by two independent expert committees convened by the NRC in response to a request from Congress and to subsequent, related requests from EPA. The Committee on Research Opportunities and Priorities for EPA – our companion committee in this study – was charged to provide an overview of significant emerging environmental issues, identify and prioritize research themes most relevant to understanding and resolving

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Strengthening Science at the U.S. Environmental Protection Agency: Research-Management and Peer-Review Practices those issues, and consider the role of EPA's research program in the context of research being conducted or supported by other organizations. That committee published an interim report in 1996 and a final report, Building a Foundation for Sound Environmental Decisions, in 1997. The Committee on Research and Peer Review in EPA – our committee – was charged to evaluate research management and scientific peer-review practices in the agency. Our committee published an interim report in 1995 and this final report. Specifically, our committee was given the following task: The committee will perform an independent assessment of the U.S. Environmental Protection Agency's overall research and development program structure, peer review procedures, long-term research program,laboratory site review procedures, and research staff career development and performance evaluation procedures. In carrying out its charge, the committee will consider the mission-related research, development, and technical support needs of EPA's regulatory programs and regional of fices; the role of EPA's research program in the context of research being conducted or sponsored by other agencies and organizations; and the problems and recommendations described in previous studies of these topics by the National Research Council, Carnegie Commission, and EPA Science Advisory Board. This report has been reviewed in draft form by individuals chosen for their technical expertise and diverse perspectives in accordance with procedures approved by the NRC's Report Review Committee for reviewing NRC and Institute of Medicine reports. The purpose of that independent review was to provide candid and critical comments to assist the NRC in making the 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, who are neither officials nor employees of the NRC, for their participation in the review of this report: John Ahearne, Sigma Xi; James Anderson, Harvard University; Barry Bozeman, Georgia Institute of Technology; Richard Conway, (Retired, Union Carbide Corporation); Costel D. Denson, University of Delaware; Freeman Gilbert, University of California, San Diego; Gilbert Omenn, University of Michigan; William Raub, U.S. Department of Health and Human Ser-

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Strengthening Science at the U.S. Environmental Protection Agency: Research-Management and Peer-Review Practices vices; W. Randall Seeker, Energy and Environmental Research Corporation; and Terry Yosie, Chemical Manufacturers Association. The individuals listed above have provided many constructive comments and suggestions. It must be emphasized, however, that responsibility for the final content of this report rests entirely with the authoring committee and the NRC. We gratefully acknowledge the contributions of more than 200 individuals from EPA and other agencies and organizations who made presentations, provided information, or otherwise aided the committee during the course of the study. We especially wish to thank Joseph Alexander, Robert Huggett, Henry Longest, Lisa Matthews, Norine Noonan, and Peter Preuss of EPA; Judy Bean, University of Miami; Ralph Cicerone, University of California at Irvine; Ellis Cowling, North Carolina State University; and Alan Krupnick, Resources for the Future. We appreciate the assistance of the NRC staff in preparing the report. Staff members who contributed to this effort are James Reisa, director of the Board on Environmental Studies and Toxicology, who served as the NRC's principal staff officer; Jamie Young, research associate; Ruth Crossgrove, editor; Millicent Anderson, assistant to the director; Tracy Holby, senior program assistant; Pamela Friedman, project assistant; and Mirsada Karalic-Loncarevic, information specialist. I would like to thank all my colleagues on the committee for their thoughtful contributions and dedicated efforts throughout the development of this report. Finally, the members and staff of our committee wish to dedicate this report to the memory of Professor Donald W. Pritchard, a committee member who passed away last year. A renowned oceanographer and educator, Don had a distinguished academic career at the Johns Hopkins University, where he served as chairman of the department of oceanography and founded the Chesapeake Bay Institute, and at the State University of New York at Stony Brook, where he served as director of the Marine Science Research Center. Don's many honors included election to the National Academy of Engineering in 1993. We shall long remember the vast knowledge and wise counsel of this distinguished scholar. Paul G. Risser Chair, Committee on Research and Peer Review in EPA

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Strengthening Science at the U.S. Environmental Protection Agency: Research-Management and Peer-Review Practices Contents     EXECUTIVE SUMMARY   1  1   EVALUATING SCIENCE AT EPA   23      The Role of Science at EPA,   23      Previous Assessments of Science at EPA,   28      This NRC Study,   30  2   RESEARCH MANAGEMENT AT EPA   35      The Role of ORD,   35      The 1995 Reorganization of ORD,   45      Research Planning,   52      The ORD Laboratories,   70      The ORD Centers,   76      The Scientific Work Force,   87  3   PEER-REVIEW PRACTICES AT EPA   99      Purposes and Benefits of Peer Review,   99      Limitations of Peer Review,   100      Peer-Review Policy Developments at EPA,   102      What Documents Are Peer-Reviewed?   108      Forms and Mechanisms of Peer Review,   112      Selection of Peer Reviewers,   116

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Strengthening Science at the U.S. Environmental Protection Agency: Research-Management and Peer-Review Practices      Documentation and Response to Peer Reviews,   117      Management and Oversight of Peer Reviews,   119  4   STRENGTHENING SCIENCE AT EPA   125      Scientific Leadership and Talent,   126      Research Continuity and Balance,   136      Research Partnerships and Outreach,   138      Research Accountability,   142      Scientific Peer Review,   144     REFERENCES   147     APPENDIX: BIOGRAPHICAL INFORMATION ON THE COMMITTEE ON RESEARCH AND PEER REVIEW IN EPA   155

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