National Academies Press: OpenBook
Suggested Citation:"Front Matter." National Research Council. 2002. Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation. Washington, DC: The National Academies Press. doi: 10.17226/10258.
×

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.

Suggested Citation:"Front Matter." National Research Council. 2002. Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation. Washington, DC: The National Academies Press. doi: 10.17226/10258.
×

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

Suggested Citation:"Front Matter." National Research Council. 2002. Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation. Washington, DC: The National Academies Press. doi: 10.17226/10258.
×

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.

Suggested Citation:"Front Matter." National Research Council. 2002. Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation. Washington, DC: The National Academies Press. doi: 10.17226/10258.
×
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Suggested Citation:"Front Matter." National Research Council. 2002. Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation. Washington, DC: The National Academies Press. doi: 10.17226/10258.
×

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.

Suggested Citation:"Front Matter." National Research Council. 2002. Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation. Washington, DC: The National Academies Press. doi: 10.17226/10258.
×

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

Suggested Citation:"Front Matter." National Research Council. 2002. Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation. Washington, DC: The National Academies Press. doi: 10.17226/10258.
×

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

Page viii Cite
Suggested Citation:"Front Matter." National Research Council. 2002. Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation. Washington, DC: The National Academies Press. doi: 10.17226/10258.
×

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

Suggested Citation:"Front Matter." National Research Council. 2002. Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation. Washington, DC: The National Academies Press. doi: 10.17226/10258.
×

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

Suggested Citation:"Front Matter." National Research Council. 2002. Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation. Washington, DC: The National Academies Press. doi: 10.17226/10258.
×

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.

Suggested Citation:"Front Matter." National Research Council. 2002. Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation. Washington, DC: The National Academies Press. doi: 10.17226/10258.
×

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

Suggested Citation:"Front Matter." National Research Council. 2002. Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation. Washington, DC: The National Academies Press. doi: 10.17226/10258.
×

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

Page xiii Cite
Suggested Citation:"Front Matter." National Research Council. 2002. Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation. Washington, DC: The National Academies Press. doi: 10.17226/10258.
×

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

Suggested Citation:"Front Matter." National Research Council. 2002. Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation. Washington, DC: The National Academies Press. doi: 10.17226/10258.
×

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

Suggested Citation:"Front Matter." National Research Council. 2002. Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation. Washington, DC: The National Academies Press. doi: 10.17226/10258.
×

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.

Suggested Citation:"Front Matter." National Research Council. 2002. Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation. Washington, DC: The National Academies Press. doi: 10.17226/10258.
×
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Page xviii Cite
Suggested Citation:"Front Matter." National Research Council. 2002. Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation. Washington, DC: The National Academies Press. doi: 10.17226/10258.
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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

Suggested Citation:"Front Matter." National Research Council. 2002. Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation. Washington, DC: The National Academies Press. doi: 10.17226/10258.
×
   

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

Suggested Citation:"Front Matter." National Research Council. 2002. Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation. Washington, DC: The National Academies Press. doi: 10.17226/10258.
×
   

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

Suggested Citation:"Front Matter." National Research Council. 2002. Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation. Washington, DC: The National Academies Press. doi: 10.17226/10258.
×

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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Transgenic crops offer the promise of increased agricultural productivity and better quality foods. But they also raise the specter of harmful environmental effects. In this new book, a panel of experts examines: • Similarities and differences between crops developed by conventional and transgenic methods • Potential for commercialized transgenic crops to change both agricultural and nonagricultural landscapes • How well the U.S. government is regulating transgenic crops to avoid any negative effects.

Environmental Effects of Transgenic Plants provides a wealth of information about transgenic processes, previous experience with the introduction of novel crops, principles of risk assessment and management, the science behind current regulatory schemes, issues in monitoring transgenic products already on the market, and more.

The book discusses public involvement—and public confidence—in biotechnology regulation. And it looks to the future, exploring the potential of genetic engineering and the prospects for environmental effects.

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