ENVIRONMENTAL EFFECTS of TRANSGENIC PLANTS

THE SCOPE AND ADEQUACY OF REGULATION

Committee on Environmental Impacts Associated with Commercialization of Transgenic Plants

Board on Agriculture and Natural Resources

Division on Earth and Life Studies

National Research Council

NATIONAL ACADEMY PRESS
Washington, D.C.



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Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation ENVIRONMENTAL EFFECTS of TRANSGENIC PLANTS THE SCOPE AND ADEQUACY OF REGULATION Committee on Environmental Impacts Associated with Commercialization of Transgenic Plants Board on Agriculture and Natural Resources Division on Earth and Life Studies National Research Council NATIONAL ACADEMY PRESS Washington, D.C.

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Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation NATIONAL ACADEMY PRESS 2101 Constitution Avenue, NW 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 study was supported by Cooperative Agreements No. 59-0790-0-173 and No. 99-1001-0229-GR between the National Academy of Sciences and the U.S. Department of Agriculture. 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 organizations or agencies that provided support for the project. Library of Congress Cataloging-in-Publication Data Environmental effects of transgenic plants : the scope and adequacy of regulation / Committee on Environmental Impacts associated with Commercialization of Transgenic Plants Board on Agriculture and Natural Resources Division on Earth and Life Studies, National Research Council. p. cm. Includes bibliographical references (p. ). ISBN 0-309-08263-3 (hardcover) 1. Transgenic plants—Risk assessment. 2. Agricultural biotechnology—Environmental aspects. I. National Research Council. Committee on Environmental Impacts. SB123.57 .E58 2002 631.5'233—dc21 2001008715 Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation is available from the National Academy Press, 2101 Constitution Avenue, N.W., Lockbox 285, Washington, DC 20055; (800) 624-6242 or (202) 334-3313 (in the Washington metropolitan area); http://www.nap.edu. Copyright 2002 by the National Academy of Sciences. All rights reserved. Printed in the United States of America

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Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation 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. Wm. 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. Wm. A. Wulf are chairman and vice chairman, respectively, of the National Research Council.

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Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation COMMITTEE* ON ENVIRONMENTAL IMPACTS ASSOCIATED WITH COMMERCIALIZATION OF TRANSGENIC PLANTS FRED L. GOULD, Chair, North Carolina State University, Raleigh DAVID A. ANDOW, University of Minnesota, St. Paul BERND BLOSSEY, Cornell University, Ithaca, New York IGNACIO CHAPELA, University of California, Berkeley NORMAN C. ELLSTRAND, University of California, Riverside NICHOLAS JORDAN, University of Minnesota, St. Paul KENDALL R. LAMKEY, Iowa State University, Ames BRIAN A. LARKINS, University of Arizona, Tucson DEBORAH K. LETOURNEAU, University of California, Santa Cruz ALAN McHUGHEN, University of Saskatchewan, Saskatoon RONALD L. PHILLIPS, University of Minnesota, St. Paul PAUL B. THOMPSON, Purdue University, West Lafayette, Indiana Staff KIM WADDELL, Study Director HEATHER CHRISTIANSEN, Research Associate KAREN L. IMHOF, Project Assistant (from January 2000 to March 2001) MICHAEL R. KISIELEWSKI, Research Assistant (since March 2001) BARBARA BODLING, Editor *   The work of this committee was overseen by the Committee on Agricultural Biotechnology, Health, and the Environment, of the Board on Agriculture and Natural Resources and the Board on Life Sciences.

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Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation COMMITTEE ON AGRICULTURAL BIOTECHNOLOGY, HEALTH, AND THE ENVIRONMENT BARBARA A. SCHAAL, Co-Chair, Washington University, St. Louis HAROLD E. VARMUS, Co-Chair, Memorial Sloan-Kettering Cancer Center, New York, New York DAVID A. ANDOW, University of Minnesota, St. Paul FREDERICK M. AUSUBEL, Harvard Medical School, Boston, Massachusetts NEAL L. FIRST, University of Wisconsin, Madison LYNN J. FREWER, Institute of Food Research, Norwich, England HENRY L. GHOLZ, National Science Foundation, Arlington, Virginia ERIC M. HALLERMAN, Virginia Polytechnic Institute and State University, Blacksburg CALESTOUS JUMA, Harvard University NOEL T. KEEN, University of California, Riverside SAMUEL B. LEHRER, Tulane University School of Medicine, New Orleans, Louisiana J. MICHAEL McGINNIS, Robert Wood Johnson Foundation, Princeton, New Jersey SANFORD A. MILLER, Georgetown University PER PINSTRUP-ANDERSON, International Food Policy Research Institute, Washington, D.C. VERNON W. RUTTAN, University of Minnesota, St. Paul ELLEN K. SILBERGELD, University of Maryland Medical School, Baltimore ROBERT E. SMITH, R.E. Smith Consulting, Inc., Newport, Vermont ALLISON A. SNOW, Ohio State University, Columbus DIANA H. WALL, Colorado State University, Fort Collins Staff JENNIFER KUZMA, Senior Program Officer LAURA HOLLIDAY, Research Assistant

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Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation BOARD ON AGRICULTURE AND NATURAL RESOURCES HARLEY W. MOON, Chair, Iowa State University CORNELIA B. FLORA, Iowa State University ROBERT B. FRIDLEY, University of California, Davis BARBARA GLENN, Federation of Animal Science Societies, Bethesda, Maryland W.R. (REG) GOMES, University of California, Oakland LINDA GOLODNER, National Consumers League, Washington, D.C. PERRY R. HAGENSTEIN, Institute for Forest Analysis, Planning, and Policy, Wayland, Massachusetts GEORGE R. HALLBERG, The Cadmus Group, Inc., Boston, Massachusetts CALESTOUS JUMA, Harvard University GILBERT A. LEVEILLE, McNeil Consumer Healthcare, Denville, New Jersey WHITNEY MacMILLAN, Cargill, Inc., Minneapolis, Minnesota (retired) TERRY L. MEDLEY, DuPont BioSolutions Enterprise, Wilmington, Delaware WILLIAM L. OGREN, U.S. Department of Agriculture (retired) ALICE PELL, Cornell University NANCY J. RACHMAN, Novigen Sciences, Inc., Washington, D.C. G. EDWARD SCHUH, University of Minnesota BRIAN STASKAWICZ, University of California, Berkeley JOHN W. SUTTIE, University of Wisconsin, Madison JAMES TUMLINSON, U.S. Department of Agriculture, Agricultural Research Service JAMES J. ZUICHES, Washington State University Staff WARREN R. MUIR, Executive Director (since June 1999) DAVID L. MEEKER, Director (from March 2000 to August 2001) CHARLOTTE KIRK BAER, Director (since September 2001) JULIE ANDREWS, Senior Project Assistant

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Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation BOARD ON LIFE SCIENCES COREY S. GOODMAN, Chair, University of California, Berkeley DAVID EISENBERG, University of California, Los Angeles DAVID J. GALAS, Keck Graduate Institute of Applied Life Science, Claremont, California BARBARA GASTEL, Texas A&M University, College Station JAMES M. GENTILE, Hope College, Holland, Michigan ROBERT T. PAINE, University of Washington, Seattle STUART L. PIMM, Columbia University JOAN B. ROSE, University of South Florida, St. Petersburg GERALD M. RUBIN, Howard Hughes Medical Institute, Chevy Chase, Maryland RAYMOND L. WHITE, University of Utah, Salt Lake City Staff WARREN R. MUIR, Executive Director (since June 1999) FRANCES SHARPLES, Director BRIDGET AVILA, Senior Project Assistant

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Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation Preface In assessing the conclusions of any report on a subject as controversial as agricultural biotechnology, I certainly would want to know about the background of the individuals who wrote the report, and the process used to write it. So before you delve into the contents of this report I would like to tell you about our committee and the process that we used in writing this report. “About the Authors” provides background information on each of the 12 committee members who wrote the report. The committee followed the general National Research Council guidelines for report writing, with more specific steps in the process determined by the committee members. This report is a consensus document. Therefore, every member of the committee had an opportunity to question the content of each page, and in the end had to determine that he or she could consent to all of the report findings and recommendations. Had any committee member written the report alone, the conclusions would have been different. Some view this as a weakness of the consensus process—too much compromise. Based on my experience with this specific report, I strongly disagree with that perspective. What I saw in our consensus process was that logic and detailed information prevailed. It was easy for us to come to consensus on some issues but in other cases there were lengthy debates. In the approximately 15 months from the time of our first meeting until we finally signed off on the report, members of the committee had time to present specific arguments on multiple occasions with the opportunity to collect data to back up their arguments in between meetings or conference calls. Evidence to me of the success of our

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Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation specific consensus process is that a report written by a single member of our committee would have been substantially different before and after he or she had gone through the study process. We learned a lot from each other, and the report reflects this enhanced pool of knowledge. The report clearly was the product of the committee, but there were a number of other important inputs. A workshop was convened by the committee to obtain input from scientists working on novel plant traits, from individuals with special expertise in regulation of transgenic plants, and from members of public interest groups (Appendix A). We also sent a letter to nearly 400 selected individuals and groups to solicit input (Appendix C). The letter specifically probed for unique perspectives on potential environmental impacts of transgenic plants. We received 35 useful, individual responses to this letter (copies available from NRC). In addition, members of the committee met with APHIS personnel and representatives from industry and public interest groups. All of these meetings were followed up by written communications to ensure that the information gathered from these meetings was accurate. The draft of our report was reviewed in detail by 12 individuals approved by the NRC’s Report Review Committee in order to provide distinct expertise and perspectives on the topics covered. The comments from the reviewers were given thorough consideration by the committee, and the Report Review Committee of the NRC assessed the revised draft before our report was accepted for publication. You will read many findings and recommendations in this report. I would like to highlight a few of them that reflect on the nature of the issues addressed, and on the study process. During the initial meetings of our committee it became apparent that there was a need to examine the environmental risks of transgenic plants within the context of environmental risks posed by the entire modern agricultural enterprise. Our assessment confirmed the general findings of others that many agricultural practices have substantial negative environmental impacts. Additionally, we found that the current standards used by the federal government to assure environmental safety of transgenic plants were higher than the standards used in assuring safety of other agricultural practices and technologies. After much discussion of this finding we did not conclude that the standards for transgenics were too high. We found that over the past 70 years there has been growing concern about the impacts of agriculture on the environment and that, in general, agricultural technologies introduced many years ago have not been as carefully scrutinized as newer technologies. Therefore, in the future, it will be important to reconsider the standards that are being used to examine environmental effects of older technologies such as conventional plant breeding.

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Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation Deliberations among our committee members—most of whom were biologists—led to a consensus that effective environmental risk analysis and management must consider both biological and social factors. While risk of environmental effects can be defined simply as a multiple of hazard and exposure, the measurement of both hazard and exposure involves a complex blend of ecological and social factors. This is in part because the value of every organism and habitat is based on its ecosystem, economic, and cultural functions. The recent assessment of risks to monarch butterflies from transgenic corn exemplifies these interactions. From a purely ecological perspective, decline in monarch butterfly populations is not, a priori, expected to be more environmentally disruptive than the decline in a randomly selected species of ground beetle. However, appropriate risk analyses for these two species should differ because of the role of the monarch butterfly in American culture. While ecologists must insist on careful examination of environmental risk to all species, decision makers cannot ignore other factors. One general finding of the committee was that a rigorous scientific risk analysis has two roles: 1) it offers essential technical information to the agencies charged with making decisions about commercializing a transgenic plant; 2) it also serves as evidence to the public that the decision-making agencies are deserving of their trust. This second role is not fully appreciated in many cases. The more clearly an agency can explain the rigor of its methods, and the more engaged it becomes in responding to the public, the more likely it is to gain the public’s confidence. The report of our committee does not paint a simple black and white picture of transgenic plant regulation by USDA-APHIS personnel. As stated in the report, our committee took on the role of searching for problems, and recommended changes “as a means to help improve a functioning system.” I hope that members of the press and other organizations will not yield to the temptation of focusing only on our finding that environmental standards for transgenic plants are higher than those for other agricultural technologies, or only on our findings that suggest the need for improvement in environmental regulation of transgenic plants. I want to thank the entire committee for their diligence and perseverance in examining mountains of background documents, and for writing and rewriting the pieces of this report. I am proud of the committee members for their willingness to argue forcefully, and for their ability to listen carefully to the perspectives of others. Without this combination of traits it would have been impossible to develop this consensus document. Special thanks go to Drs. Norman Ellstrand, David Andow, Bernd Blossey, and Paul Thompson for their leadership roles with the major organizing and writing responsibilities. External reviewers substantially improved

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Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation the content of the report, and our technical editor, Barbara Bodling, improved the prose. Karen Imhof and Mike Kisielewski offered valuable technical and organizational expertise in setting up meetings and in pull-ing the report together. Heather Christiansen’s research efforts gave us access to essential information from both the public and private sectors. The study process and the writing of this report could not have been accomplished without the hard work, insight, and diplomacy of our study director, Dr. Kim Waddell. Fred Gould Chair Committee on Environmental Impacts Associated with Commercialization of Transgenic Crops

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Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation Acknowledgments This study was enhanced by the contributions of many individuals who graciously offered their time, expertise, and knowledge. The committee thanks all who attended and/or participated in its public work-shop: STANELY ABRAMSON, Arent, Fox, Kintner, Plotkin, & Kahn, Washington, D.C. DAVID E. ADELMAN, Natural Resources Defense Council, Washington, D.C. FAITH CAMPBELL, American Lands Alliance, Washington, D.C. THOMAS CORS, Dynamics Technology, Arlington, Virginia DEAN DELLAPENNA, Michigan State University, East Lansing SHARON FRIEDMAN, Office of Science and Technology Policy, Executive Office of the President, Washington, D.C. ELIOT HERMAN, Climate Stress Laboratory, Beltsville, Maryland MAUREEN K. HINKLE, National Audubon Society, Bethesda, Maryland SHIRLEY INGEBRITSEN, U.S. Department of Agriculture, Animal and Plant Health Inspection Service, Riverdale, Maryland GANESH KISHORE, Monsanto Company (formerly), St. Louis, Missouri WARREN LEON, Northeast Sustainable Energy Association, Greenfield, Massachusetts TERRY L. MEDLEY, Dupont BioSolutions Enterprise, Wilmington, Delaware

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Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation DEBORAH OLSTER, National Science Foundation, Arlington, Virginia CRAIG ROSELAND, U.S. Department of Agriculture, Animal and Plant Health Inspection Service, Riverdale, Maryland JOAN ROTHENBERG, Institute of Food Technology, Washington, D.C. ALLISON SNOW, Ohio State University, Columbus ED SOULE, McDonough School of Business, Washington, D.C. JOHN TURNER, U.S. Department of Agriculture, Animal and Plant Health Inspection Service, Riverdale, Maryland MICHAEL F. THOMASHOW, Michigan State University, East Lansing LAREESA WOLFENBERGER, U.S. Environmental Protection Agency, Washington, D.C. The committee extends its appreciation to the staff members of the National Research Council’s (NRC) Division on Earth and Life Studies and Board on Agriculture and Natural Resources for their commitment to the study process and their efforts in preparing this report. This report has been reviewed in draft form by individuals chosen for their diverse perpectives 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 thank the following individuals for their review of this report: STEVEN LINDOW, University of California, Berkeley ROGER BEACHY, Donald Danforth Plant Science Center MAY BERENBAUM, University of Illinois ALLISON SNOW, The Ohio State University TERRY L. MEDLEY, DuPont BioSolutions Enterprise JAMES PRATT, Portland State University DANIEL SIMBERLOFF, The University of Tennessee JANE RISSLER, Union of Concerned Scientists THOMAS E. NICKSON, Monsanto Company, St. Louis, Missouri WYATT ANDERSON, University of Georgia DOUGLASS GURIAN-SHERMAN, Center for Science in the Public Interest FREDERICK BUTTEL, University of Wisconsin

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Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation Although the reviewers 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 T. Clegg, University of California, Riverside, and John E. Dowling, Harvard University. 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.

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Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation Contents     EXECUTIVE SUMMARY   1     Task of the Committee,   1     Comparison of Environmental Assessment of Transgenic Plants with Assessment of Other Agricultural Technologies,   2     Environmental Effects of Agricultural Practices, Novel Genetic Material, and the Processes Used in Plant Improvement,   3     Risk Analysis and the Regulation of Transgenic Plants: Scientific Assumptions and Premises,   6     Analysis of the APHIS Regulatory Process,   7     Postcommercialization Testing and Monitoring,   12     Looking Toward the Future,   14     ECOLOGICAL, GENETIC, AND SOCIAL FACTORS AFFECTING ENVIRONMENTAL ASSESSMENT OF TRANSGENIC PLANTS   17     Developing a Twenty-First-Century View of Agriculture and the Environment,   17     Role of this Report,   19     Environmental Effects of Agroecosystems on Surrounding Ecosystems,   21     Flows of Materials and Organisms from Agroecosystems,   23

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Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation     Effects of Outflows of Materials and Organisms on Neighboring Ecosystems,   24     Landscape-Level Effects of Agriculture,   27     Environmental Impacts of the Deliberate Introduction of Biological Novelty: From Genes to Minicommunities,   28     Comparing and Contrasting Conventional and Transgenic Approaches to Crop Improvement,   36     Traditional and Conventional Processes of Crop Improvement,   37     Transgenic Techniques for Crop Improvement,   43     Overview of Current U.S. Regulatory Framework for Transgenic Organisms,   49     SCIENTIFIC ASSUMPTIONS AND PREMISES UNDERPINNING THE REGULATION AND OVERSIGHT OF ENVIRONMENTAL RISKS OF TRANSGENIC PLANTS   52     Risk,   53     Roles of Risk Analysis,   56     Terminology of Risk Analysis,   58     Risk Analysis as Decision Support in the Regulation of Transgenic Plants,   62     Risk Analysis for Creating Legitimacy,   63     Scientific Assumptions Underpinning Regulation of Transgenic Crops,   65     The Categories of Hazards,   65     Environmental Risks of Transgenic Crops and Conventionally Bred Crops,   77     The Trigger for Risk Analysis,   79     Reference Scenarios—The Comparative Risk Approach,   87     Appropriate Reference Scenarios,   88     Characterizing the Transgenic Organism,   90     Risk Assessment Models,   93     Conclusion,   99     APHIS REGULATORY POLICY FOR TRANSGENIC ORGANISMS   101     Overview,   101     Scope and Regulatory Procedures Used by APHIS,   106     Notification System for Introduction of Certain Regulated Articles (7 CFR 340.3),   107     Petition for Determination of Nonregulated Status (CFR 340.6),   111

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Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation     Requests for Extension of Determination of Nonregulated Status to Additional Regulated Articles,   118     Conclusion,   120     CASE STUDIES OF APHIS ASSESSMENTS   121     Notification Process Case Study,   121     Notification for Salt- and Drought-Tolerant Bermudagrass,   121     The Permitting Process,   123     Permitting of Maize Expressing Proteins with Pharmaceutical Applications,   123     Petitions for Deregulated Status: Four Case Studies Involving Six Petitions,   126     Two Virus-Resistant Squash Petitions,   126     Soybean with Altered Oil Profile,   136     Two Bt Corn Petitions,   144     Herbicide-Tolerant and Insect-Resistant Cotton,   158     Conclusion,   166     ANALYSIS OF APHIS ASSESSMENTS   167     Analysis of Public Involvement,   168     External Input into the Decision-Making Process,   169     External Input into the Establishment of Policy,   171     Effectiveness of Efforts to Solicit External Input,   171     Technical Analysis of APHIS Oversight,   175     General Comments and Concerns,   176     Technical Analysis of the Notification Process,   178     Technical Analysis of the Permitting Process,   183     Technical Analysis of the Petition Process,   183     Changes in APHIS Oversight over Time,   190     Conclusion,   191     POSTCOMMERCIALIZATION TESTING AND MONITORING FOR ENVIRONMENTAL EFFECTS OF TRANSGENIC PLANTS   192     Introduction,   192     Theoretical Justification for Monitoring and Validation After Commercialization of Transgenic Crops,   193     Postcommercialization Validation Testing,   196     Status of Long-Term Environmental Monitoring in the United States,   198     Selection of Appropriate Variables to Monitor,   203     Development of Monitoring Programs for Transgenic Crops,   204

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Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation     Trained-Observer Monitoring,   205     Need,   205     Logistics,   206     Needed Training,   206     Long-Term Monitoring and the Use of Bioindicators,   207     Need,   207     Monitoring Transgenic Crops,   208     Monitoring Using Biological Indicators,   208     Responses to Monitoring,   213     Need,   213     Examples of Responses,   216     Conclusion,   218     THE FUTURE OF AGRICULTURAL BIOTECHNOLOGY   220     The Next Transgenic Crops,   221     An Inventory of New Transgenic Crops,   221     Potential Environmental Impacts of Novel Traits,   230     Future Policy Issues,   236     Agricultural Structure,   237     Biotechnology, World Food Supply, and Environmental Risk,   237     Involving the Public and Communicating Environmental Risk,   242     Regulatory Issues,   245     The Need for Strategic Public Investment in Research,   254     Improved Risk Analysis Methodologies and Protocols,   255     Postcommercialization Validation and Monitoring,   256     Improved Transgenic Methods to Reduce Risks and Improve Benefits to the Environment,   258     Value-Oriented Research,   258     REFERENCES   260     APPENDIXES         A. Workshop to Assess the Regulatory Oversight of GM Crops and the Next Generation of Genetic Modifications for Crop Plants: Agenda   289     B. Workshop Presenters/Panelists   291     C. “Dear Colleague Letter”   295     D. “Dear Colleague Letter” Recipients   298     ABOUT THE AUTHORS   301     BOARD ON AGRICULTURE AND NATURAL RESOURCES PUBLICATIONS   305     INDEX   309

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Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation TABLES, FIGURES, AND BOXES Tables 5.1   APHIS Involvement of Potential Participant Groups in the Process of Commercializing a Transgenic Plant or Its Products,   169 5.2   Public Involvement in Policy Making for Risk Assessment and Management,   172 Figures 2.1   Venn diagram illustrating that invasive species are a small subset of all possible nonindigenous species,   82 2.2   A. Set of all conventional crop plants and those with unacceptable environmental risks;   84     B. Similar diagram for transgenic crop plants,   84 2.3   A. Set of all conventional crop plants with the small subset that have environmental risks;   85     B. Similar diagram for all transgenic crop plants,   85 2.4   Simplified fictitious fault-tree analysis of the risk that individuals of species X are killed by the sum of three varieties of Bt corn,   94 2.5   Simplified fault-tree model of the risk that a commercialized hazardous transgene product enters the human food chain via the environment,   95 2.6   Simplified event-tree analysis of the non-target risk of a toxin produced in a transgenic plant,   97 Boxes 1.1   The Green Revolution,   34 1.2   Traits and Characters,   38 1.3   Types and Consequences of Transgene Silencing,   46 2.1   Effect of Bt Corn on Monarch Butterflies,   72 3.1   Key Definitions Used by APHIS,   103 4.1   The Mysterious Ecological Role of Bt Toxins,   162 5.1   Avidin,   180 6.1   Information Currently Contained in the NRI,   200 6.2   Indicators of the Nation’s Ecological Capital,   210 6.3   Role of Monitoring,   214

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