GENETICALLY MODIFIED PEST-PROTECTED PLANTS

SCIENCE AND REGULATION

Committee on Genetically Modified Pest-Protected Plants

Board on Agriculture and Natural Resources

National Research Council

NATIONAL ACADEMY PRESS
Washington, D.C.



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GENETICALLY MODIFIED PEST-PROTECTED PLANTS: SCIENCE AND REGULATION GENETICALLY MODIFIED PEST-PROTECTED PLANTS SCIENCE AND REGULATION Committee on Genetically Modified Pest-Protected Plants Board on Agriculture and Natural Resources National Research Council NATIONAL ACADEMY PRESS Washington, D.C.

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GENETICALLY MODIFIED PEST-PROTECTED PLANTS: SCIENCE AND REGULATION NATIONAL ACADEMY PRESS 2101 Constitution Avenue, NW 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. Library of Congress Cataloging-in-Publication Data Genetically modified pest-protected plants : science and regulation / Committee on Genetically Modified Pest-Protected Plants, Board on Agriculture and Natural Resources, National Research Council. p. cm. Includes bibliographical references and index. ISBN 0-309-06930-0 (casebound) 1. Transgenic plants—Risk assessment. 2. Plants—Disease and pest resistance—Genetic aspects. I. National Research Council (U.S.). Committee on Genetically Modified Pest-Protected Plants. SB123.57 G48 2000 631.5′233—dc21 00-009457 Genetically Modified Pest-Protected Plants: Science and Regulation is available from National Academy Press, 2101 Constitution Avenue, NW,Lockbox 285, Washington, DC 20055; (800) 624-6242 or (202) 334-3313 (in the Washington metropolitan area); Internet, 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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GENETICALLY MODIFIED PEST-PROTECTED PLANTS: SCIENCE AND 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. 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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GENETICALLY MODIFIED PEST-PROTECTED PLANTS: SCIENCE AND REGULATION COMMITTEE ON GENETICALLY MODIFIED PEST-PROTECTED PLANTS PERRY ADKISSON, Chair, Texas A&M University, College Station STANLEY ABRAMSON, Arent, Fox, Kintner, Plotkin & Kahn, Washington, D.C. STEPHEN BAENZIGER, University of Nebraska, Lincoln FRED BETZ, Jellinek, Schwartz & Connolly, Arlington, Virginia JAMES C. CARRINGTON, Washington State University, Pullman REBECCA J. GOLDBURG, Environmental Defense, New York, NY FRED GOULD, North Carolina State University, Raleigh ERNEST HODGSON, North Carolina State University, Raleigh TOBI JONES, California Department of Pesticide Regulation, Sacramento MORRIS LEVIN, University of Maryland, Baltimore ERIK LICHTENBERG, University of Maryland, College Park ALLISON SNOW, Ohio State University, Columbus Staff JENNIFER KUZMA, Study Director MICHAEL J. PHILLIPS, Study Director (through July 1999)* JAMIE YOUNG, Research Associate KAREN L. IMHOF, Project Assistant DEREK SWEATT, Project Assistant NORMAN GROSSBLATT, Editor * Michael Phillips was involved with this study until 7/13/99 and is currently employed with the Biotechnology Industry Organization.

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GENETICALLY MODIFIED PEST-PROTECTED PLANTS: SCIENCE AND REGULATION BOARD ON AGRICULTURE AND NATURAL RESOURCES T. KENT KIRK, Chair, University of Wisconsin, Madison DAVID BAKER, University of Illinois SANDRA S. BATIE, Michigan State University MAY R. BERENBAUM, University of Illinois ANTHONY S. EARL, Quarles & Brady Law Firm, Madison, Wisconsin ESSEX E. FINNEY, JR., U.S. Department of Agriculture (retired), Mitchellville, Maryland CORNELIA FLORA, Iowa State University ROBERT T. FRALEY, Monsanto Company GEORGE R. HALLBERG, The Cadmus Group, Boston, Massachusetts RICHARD R. HARWOOD, Michigan State University GILBERT A. LEVEILLE, McNeil Consumer Healthcare, Fort Washington, Pennsylvania HARLEY W. MOON, Iowa State University WILLIAM L. OGREN, University of Illinois G. EDWARD SCHUH, University of Minnesota JOHN W. SUTTIE, University of Wisconsin THOMAS N. URBAN, Pioneer Hi-Bred International, Inc. ROBERT T. WILSON, Mississippi State University JAMES J. ZUICHES, Washington State University Staff WARREN R. MUIR, Executive Director MYRON F. UMAN, Acting Executive Director (through June 1999) DAVID L. MEEKER, Director (since March 2000) CHARLOTTE KIRK BAER, Associate Director

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GENETICALLY MODIFIED PEST-PROTECTED PLANTS: SCIENCE AND REGULATION Foreword THE CONTEXT OF THIS REPORT A revolution has been taking place in the life sciences, sparked by striking advances in our fundamental understanding of living systems. These advances have led to the development of powerful molecular techniques, which can help society to conquer human disease, improve food production, and better protect the environment. As with all new scientific developments, however, potential risks need to be carefully evaluated and dealt with appropriately. The National Academies are committed to bringing together experts to discuss and comment on the scientific issues surrounding the application of biotechnology to important modern-day problems. In 1987 the National Academy of Sciences issued a white paper on the “Introduction of Recombinant DNA-Engineered Organisms into the Environment,” which dealt with general principles concerning potential ecological risks in field testing. In his preface, my predecessor, Frank Press, stated that the paper “applies the relevant scientific principles” to key issues, but was not intended to “resolve questions pertaining to the establishment of specific regulations or guidelines governing release procedures.” In 1989, the National Research Council issued the report, “Field Testing Genetically Modified Organisms: Framework for Decisions,” which addressed the ecological risks of small-scale field testing of engineered organisms. Neither potential human health risks, nor issues raised

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GENETICALLY MODIFIED PEST-PROTECTED PLANTS: SCIENCE AND REGULATION by large-scale commercial planting, were addressed in that study which considered scientific issues primarily, not regulatory policy. These two reports reflected the best judgment of two highly expert groups of scientists, and they were based on the scientific evidence available to them at the time. The full text of these and all other reports from the National Academies are available on the Worldwide Web at www.nap.edu. Utilizing information gained over the past decade, the National Research Council is releasing this important report on genetically modified pest-protected plants. Prepared by another expert committee, it provides timely advice to researchers, developers, and regulatory agencies involved in reviewing the science surrounding the regulation of genetically modified pest-protected crops. The report addresses only one aspect of the ongoing revolution in the life sciences and agriculture, and it is careful to point out where more research and scientific information is needed to answer remaining questions. The National Research Council intends for it to be only the first of several reports to be produced over the next couple of years. We have recently established a standing committee on Biotechnology, Food and Fiber Production, and the Environment. This committee will oversee a wide range of studies, workshops, and meetings. In this way, we look forward to being able to contribute on an ongoing basis to discussions of the important and timely issues surrounding agricultural biotechnology. PROTECTING PLANTS FROM PESTS Agriculture has been suffering from pest and disease infestation since its inception, causing enormous, unpredictable losses in food production. Genetic engineering of plants for resistance to pests and disease, creating transgenic pest-protected plants, is one of the many tools for increasing food security. It is embedded within the long-standing science of conventional breeding for plant improvement. The use of chemicals to control pests1 can be abated and perhaps someday eliminated by the appropriate use of transgenic methods, combined with conventional plant breeding and other techniques of sustainable agriculture. Many valuable technologies will form the basis for future plant protection. The appropriate balance among them will be pest- and situation-specific. Given time constraints, this report does not include an in-depth 1   The forthcoming NRC report The Future Role of Pesticides in U.S. Agriculture, will deal with the use of chemicals as a trend in pest management.

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GENETICALLY MODIFIED PEST-PROTECTED PLANTS: SCIENCE AND REGULATION analysis of this balance.2 It instead provides an overview of the use of transgenic techniques to enhance the pest resistance of crops, with a focus on the regulatory system that oversees the introduction of transgenic pest-protected plants. In this sense, it is but one contribution to the larger and complex system of pest management, as well as to the broader issues surrounding the often virulent debate about using modern biotechnology to improve agricultural production. THE PREPARATION OF THIS REPORT In the preparation of this report, much effort was placed on selecting highly qualified experts capable of addressing the scientific and regulatory issues surrounding the regulation of genetically modified pest-protected plants. Care was also given to achieving an appropriate balance of viewpoints. Suggestions for committee members came from many different sources, including extensive public comments. This report represents the consensus views of the 12 experts who were selected by the National Research Council to undertake the study. Care was also given to ensuring that the committee received input and information from all concerned and interested parties. A public workshop was held in which the public and many panelists from diverse perspectives were invited to express their ideas and concerns about transgenic pest-protected plants and the regulatory framework guiding their commercial use. The committee's analysis utilized input from the workshop, as well as from a variety of other scientific sources. Although funded entirely with internal funds from the National Academies, the public disclosure procedures of Section 15 of the Federal Advisory Committee Act were used to guide the committee process. Committee membership and public workshops were posted on the Web on our Current Projects system. As with all NRC studies, this report has been subject to an extensive independent peer review. Twelve scientific and regulatory experts, representing a broad range of viewpoints, reviewed the report and provided extensive comments, and they thereby helped the committee to strengthen the report. 2   The 1996 NRC report, Ecologically Based Pest Management – New Solutions for a New Century provides an overview of the management of the myriad biological processes that suppress pest buildup and damage and of the increasing contributions of production ecto the future of agriculture. Available online at http://books.nap.edu/catalog/5135.html.

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GENETICALLY MODIFIED PEST-PROTECTED PLANTS: SCIENCE AND REGULATION ACKNOWLEDGMENTS I would like to thank Dr. Perry Adkisson, the committee chair, and the 11 other committee members for their dedicated, pro bono work on this study. Special thanks are also due to Dr. Jennifer Kuzma, who took over last July as the NRC Responsible Staff Officer for this report, early in its preparation. Bruce Alberts Chairman National Research Council

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GENETICALLY MODIFIED PEST-PROTECTED PLANTS: SCIENCE AND REGULATION Preface Transgenic pest-protected crops were first commercially planted in the United States in 1995. Since then the acreage planted to transgenic crops has increased rapidly with some 70 million acres being grown in the United States, and 98.6 globally in 1999. Of this acreage, a large percentage (for example, 30 million acres in the US in 1999) is planted with transgenic pest-protected crop varieties containing the Bacillus thuringiensis (Bt) gene which confers protection from certain insect pests and with varieties that are herbicide-tolerant. In 1998, about 25% of the US cotton acreage and 21% of the corn acreage was planted with varieties containing Bt genes. This increase in acreage planted in transgenic crops has largely resulted because of benefits produced to farmers. Many farmers are growing transgenic crops because they either produce more effective control of serious pests than conventional chemical treatments, or they provide control at lower costs than conventional treatments, or both. The growing of some Bt crops has been accompanied by a reduction in the amounts of chemical pesticides previously used on these crops. This has produced a side benefit in terms of reducing exposure of humans and other non-target organisms to these toxic chemicals and lessening the contamination of air and water. Given the rapid increase in plantings of transgenic varieties, concerns have been raised about the ecological and human health risks that might be posed by these crops. Although these risks might not in principle differ in type from those associated with other conventionally-bred pest-resistant varieties or chemical pesticides, they nevertheless have become a focus of attention by several groups who are concerned by potential

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GENETICALLY MODIFIED PEST-PROTECTED PLANTS: SCIENCE AND REGULATION Acknowledgments The committee wishes to express its thanks to the staff members of the Board on Agriculture and Natural Resources for their invaluable assistance in the conduct of this study and the preparation of this report. Special thanks are due to Dr. Jennifer Kuzma, Project Director, for her dedicated efforts and hard work in compiling and assimilating the reports of the various subgroups of the committee and for shepherding the report through several reiterations to completion. The committee appreciates her technical competence in the conduct of the study and her diplomacy in resolving differences that arose during the writing of the report. The committee wishes to recognize the efforts of Dr. Michael Phillips who was study director of the project for the first four months. The committee also wishes to recognize the outstanding work of Ms. Jamie Young, Research Associate, Ms. Karen Imhof, Project Assistant, and Mr. Derek Sweatt, Project Assistant, for their assistance in the work of the committee and preparation of this report. The committee appreciates the input of Dr. Jim Reisa, Director of the Board on Environmental Studies and Toxicology, in guiding project staff. The committee also acknowledges Mr. Norman Grossblatt, Editor, for his expert editorial assistance in improving the final draft of the report. Special thanks are due tocommittee members Dr. Fred Gould and Mr. Stanley Abramson for assuming a large share of the workload of the committee by chairing the two technical subgroups that developed the bulk of the report.

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GENETICALLY MODIFIED PEST-PROTECTED PLANTS: SCIENCE AND REGULATION The committee expresses their gratitude to the following people for the information they provided to the committee. In some cases, the committee needed to obtain information on short notice, and the committee appreciates the efforts of these people to fulfill these requests. Richard Allison, Michigan State University Janet Andersen, Biopesticides and Pollution Prevention Division, Environmental Protection Agency Nega Beru, Center for Food Safety and Applied Nutrition, Food and Drug Administration Stacy Carey, House Agriculture Committee Tom Carrato, Monsanto Company Harold Coble, North Carolina State University James Cook, Washington State University Kent Croon, Monsanto Company Tim Debus, United Fresh Fruit and Vegetable Association Kathryn DiMatteo, Organic Trade Association Steven Druker, Alliance for Biointegrity Nina Fedoroff, Pennslyvania State University David Ferro, University of Massachusetts at Amherst Vasilios Frankos, Environ Alan Goldhammer, Biotechnology Industry Organization Dennis Gonsalves, Cornell University Bob Harness, Monsanto Company David Heron, Animal and Plant Health Inspection Service, United States Department of Agriculture Jason Hlywka, University of Nebraska at Lincoln Karen Hokanson, Animal and Plant Health Inspection Service, United States Department of Agriculture Phil Hutton, Biopesticides and Pollution Prevention Division, Environmental Protection Agency Peter Kareiva, Department of Commerce John Kough, Biopesticides and Pollution Prevention Division, Environmental Protection Agency Marc Lappe, Center for Ethics and Toxics Nina Mani, George Washington University James Maryanski, Center for Food Safety and Applied Nutrition, Food and Drug Administration Sally McCammon, Animal and Plant Health Inspection Service, United States Department of Agriculture Terry Medley, DuPont Company Margaret Mellon, Union of Concerned Scientists

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GENETICALLY MODIFIED PEST-PROTECTED PLANTS: SCIENCE AND REGULATION Mike Mendelsohn, Biopesticides and Pollution Prevention Division, Environmental Protection Agency Robert Mustell, National Corn Growers Association William Price, Center for Veterinary Medicine, Food and Drug Administration Phil Regal, University of Minnesota Marlin Rice, Iowa State University Jennifer Riebe, Monsanto Company, NatureMark Jane Rissler, Union of Concerned Scientists Russ Schneider, Monsanto Company Doreen Stabinsky, California State University Guenther Stotzy, New York University Gail Tomimatsu, Biopesticides and Pollution Prevention Division, Environmental Protection Agency Robert Torla, Biopesticides and Pollution Prevention Division, Environmental Protection Agency John Trumble, University of California, Riverside Rick Welsh, Wallace Institute James White, Animal and Plant Health Inspection Service, United States Department of Agriculture

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GENETICALLY MODIFIED PEST-PROTECTED PLANTS: SCIENCE AND REGULATION Acknowledgment of Reviewers This report has been reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise in accordance with procedures for reviewing NRC reports 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 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 content of the final report is the responsibility of the NRC and the study committee, and not the responsibility of the reviewers. 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 Antle, Montana State University John Benedict, Texas A&M University Joy Bergelson, University of Chicago Edwin Clark II, Washington, DC John Dowling, Harvard University Robert Fraley, Monsanto Company Sarjeet Gill, University of California - Riverside Lynn Goldman, Johns Hopkins University Walter Goldstein, Michael Fields Agricultural Institute

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GENETICALLY MODIFIED PEST-PROTECTED PLANTS: SCIENCE AND REGULATION Richard Harwood, Michigan State University Susan Hefle, University of Nebraska at Lincoln Jane Rissler, Union of Concerned Scientists Jozef S. Schell, Max Planck Institute for Breeding Research Luis Sequeira, University of Wisconsin 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.

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GENETICALLY MODIFIED PEST-PROTECTED PLANTS: SCIENCE AND REGULATION Contents     EXECUTIVE SUMMARY   1     ES.1  Purpose and Scope of This Study,   1     ES.2  Future Studies and Limitations of the Current Study,   3     ES.3  Report Terminology,   4     ES.4  Review of the 1987 National Academy of Sciences Principles,   5     ES.5  Potential Health and Ecological Impacts and Research Needs,   6     ES.6  The Coordinated Framework for Regulation,   10     ES.7  Operational Aspects and Impacts of the Coordinated Framework,   15     ES.8  Striving for the Ideal Regulatory Framework,   18  1   INTRODUCTION AND BACKGROUND   19     1.1  The Importance of Crop Protection,   19     1.2  Diverse Genetic Modification Methods,   20     1.3  History and Impact of Breeding Methods,   22     1.4  Emergence of Recombinant DNA and Overview of Transgenic Pest-Protected Plants,   23     1.5  Agency Policies Regarding Commercialization of Transgenic Pest-Protected Plants,   28     1.6  Public Concerns and Issues,   34     1.7  Role of This Report,   38

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GENETICALLY MODIFIED PEST-PROTECTED PLANTS: SCIENCE AND REGULATION  2   POTENTIAL ENVIRONMENTAL AND HUMAN HEALTH IMPLICATIONS OF PEST-PROTECTED PLANTS   40     2.1  Risk Assessment and Pest-Protected Plants,   40     2.2  Review of Previous National Academy of Sciences and National Research Council Reports,   42     2.3  Forms and Mechanisms of Genetically Controlled Pest-Protection,   46     2.4  Potential Health Effects of Diverse Gene Products and Breeding Methods,   54     2.5  Potential Human Health Effects,   62     2.6  Potential Effects on Nontarget Organisms,   73     2.7  Gene Flow from Transgenic Pest-Protected Plants,   80     2.8  Agronomic Risks Associated With Virus-Resistant Crops,   93     2.9  Pest Resistance to Pest-Protected Plants and Resistance Management,   95     2.10  Recommendations,   102  3   CROSSROADS OF SCIENCE AND OVERSIGHT   104     3.1  Case Studies of Pest-Protected Crops and Their Oversight,   104     3.2  Analysis of the 1994 and 1997 Proposed Environmental Protection Agency Rules for Plant-Pesticides,   126     3.3  Suggested Questions for Oversight,   135     3.4  Research Needs,   139     3.5  Recommendations,   142  4   STRENGTHS AND WEAKNESSES OF THE CURRENT REGULATORY FRAMEWORK   144     4.1  Overview of the Regulation of Plant Products Under the Coordinated Framework,   144     4.2  Evaluation of the Environmental Protection Agency's Regulation of Pesticidal Substances in Plants Under the 1994 Proposed Rule,   151     4.3  Evaluation of the Regulation of Transgenic Pest-Protected Plants under the Multiagency Approach of the Coordinated Framework,   155     4.4  Impacts of the Coordinated Framework,   178     4.5  Recommendations,   179     REFERENCES   182

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GENETICALLY MODIFIED PEST-PROTECTED PLANTS: SCIENCE AND REGULATION     APPENDIXES       A  Costs of Regulating Transgenic Pest-Protected Plants   211     B  Example of Data Submitted to Federal Agencies   238     C  Committee on Genetically Modified Pest-Protected Plants Public Workshop   241     D  Acronyms   246     E  Scientific And Common Names   247     F  Committee and Staff Biographical Information   249     Index   255

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