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Environmental Contamination, Biotechnology, and the Law: The Impact of Emerging Genomic Information

Summary of a Forum Held at the National Academy of Sciences

August 16, 2000

Washington, D.C.

By

Robert Pool, Ph.D., Tallahassee, Florida

National Research Council

NATIONAL ACADEMY PRESS
Washington, D.C.



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Page i Environmental Contamination, Biotechnology, and the Law: The Impact of Emerging Genomic Information Summary of a Forum Held at the National Academy of Sciences August 16, 2000 Washington, D.C. By Robert Pool, Ph.D., Tallahassee, Florida National Research Council NATIONAL ACADEMY PRESS Washington, D.C.

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Page ii NATIONAL ACADEMY PRESS 2101 Constitution Ave., N.W. Washington, DC 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 Grant DE-FG02-94ER61939 between the National Academy of Sciences and the US Department of Energy and Contract N01-OD-4-2139 between the National Academy of Sciences and the National Cancer Institute. Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the author(s) and do not necessarily reflect the view of the organizations or agencies that provided support for this project. International Standard Book Number 0-309-07418-5 Additional copies of this report are available from: National Academy Press 2101 Constitution Ave., NW Box 285 Washington, DC 20055 800-624-6242 202-334-3313 (in the Washington metropolitan area) 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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Page iii 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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Page v PLANNING GROUP FOR THE FORUM ON ENVIRONMENTAL CONTAMINATION, BIOTECHNOLOGY, AND THE LAW: THE IMPACT OF EMERGING GENOMIC INFORMATION FREDERICK R. ANDERSON, Cadwalader, Wickersham & Taft, Washington, DC DONALD R. MATTISON, March of Dimes Birth Defects Foundation,White Plains, New York CHARLES O'MELIA, Johns Hopkins University, Baltimore, Maryland MARGARET N. STRAND, Oppenheimer, Wolff, Donnelly & Bayh, Washington, DC Science Writer ROBERT POOL, Tallahassee, Florida NRC Staff ABIGAIL STACK, Project Director EMILY SMAIL, Senior Project Assistant JESSICA BROCK, Project Assistant Sponsors U.S. Department of Energy National Cancer Institute

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Page vii BOARD ON LIFE SCIENCES COREY S. GOODMAN, (Chair), University of California, Berkeley, California MICHAEL T. CLEGG, University of California, Riverside, California DAVID S. EISENBERG, University of California, Los Angeles, California DAVID J. GALAS, Keck Graduate Institute of Applied Life Science, Claremont, California BARBARA GASTEL, Texas A&M University, College Station, Texas JAMES M. GENTILE, Hope College, Holland, MI DAVID V. GOEDDEL, Tularik, Inc., South San Francisco, California ELLIOT M. MEYEROWITZ, California Institute of Technology, Pasadena, California ROBERT T. PAINE, University of Washington, Seattle, Washington STUART L. PIMM, Columbia University, New York, New York JOAN B. ROSE, University of South Florida, St. Petersburg, Florida GERALD M. RUBIN, Howard Hughes Biomedical Research, Chevy Chase, Maryland ROBERT R. SOKAL, State University of New York, Stony Brook, New York SHIRLEY M. TILGHMAN, Princeton University, Princeton, New Jersey RAYMOND L. WHITE, DNA Sciences, Inc., Fremont, California Senior Staff FRANCES SHARPLES, Director

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Page ix Background In 1993, the National Research Council's (NRC) Board on Life Sciences (formerly named the Board on Biology) established a series of forums to explore various topics related to the field of biotechnology. The purpose of these forums is to foster open communication among scientists, policy-makers, and others involved in biotechnology-related research, development, and commercialization. The neutral setting offered by the NRC is intended to promote mutual understanding among government, industry, and academe and to help develop imaginative approaches to problem-solving. The objective of the forums is to illuminate issues, not to resolve them. The forums cannot provide advice or recommendations to any government agency or other organization. Summaries of forums are prohibited from reaching conclusions or recommendations, but instead are intended to reflect the variety of opinions expressed by the speakers. The first forum, held in 1996, focused on intellectual-property rights issues related to plant biotechnology. Other forums have focused on issues related to developing an agricultural genome project, privacy in biomedical and clinical research, and the field of bioinformatics. On August 16, 2000, the Board on Life Sciences held a forum on “Environmental Contamination, Biotechnology, and the Law: The Impact of Emerging Genomic Information.” The purpose of the forum was to explore the legal implications of current and developing biotechnology approaches to evaluating potential human health and environmental effects caused by exposure to environmental contaminants and to cleaning up contaminated areas. The forum brought together scientists from academe, government, and industry and members of the

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Page x legal community, including lawyers and judges, to discuss the interface between the use of those approaches and the legal system. NRC staff was assisted in planning the forum by Frederick R. Anderson, of Cadwalader, Wickersham & Taft, Washington, DC; Donald R. Mattison, of the March of Dimes Birth Defects Foundation, White Plains, New York; Charles O'Melia, of Johns Hopkins University, Baltimore, Maryland; and Margaret N. Strand, of Oppenheimer, Wolff, Donnelly & Bayh, Washington, DC. The planning group suggested topics and speakers and provided comments on drafts of the forum agenda; they did not participate in the preparation of the forum summary. 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 forum 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 L. Eaton, of University of Washington, Seattle, Washington; Sidney Green, of Howard University, Washington, DC; Richard A. Merrill, of University of Virginia School of Law, Charlottesville, Virginia; and Margaret N. Strand, of Oppenheimer, Wolff, Donnelly & Bayh, Washington, DC. Although the reviewers listed above have provided many constructive comments and suggestions, they did not see the final draft of the report before its release. The review of this report was overseen by Raymond L. White, of DNA Sciences, Inc., Fremont, California. Appointed by the National Research Council, he was 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 author and the institution.

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Page xi Contents 1     INTRODUCTION: GENOMICS, ENVIRONMENT, AND HEALTH 1 2     FORUM SUMMARY 4     Genomics and Environmental Health, 4     Genomics and Cleaning the Environment, 7     Legal Implications, 13     Summary of Key Points, 22 APPENDIXES A     FORUM AGENDA 27 B     SPEAKER BIOGRAPHIES 29

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