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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.
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
Genetically Modified Pest-Protected Plants: Science and Regulation is available from
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THE NATIONAL ACADEMIES
National Academy of Sciences
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Institute of Medicine
National Research Council
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COMMITTEE ON GENETICALLY MODIFIED PEST-PROTECTED PLANTS
PERRY ADKISSON, Chair,
Texas A&M University, College Station
Arent, Fox, Kintner, Plotkin & Kahn, Washington, D.C.
University of Nebraska, Lincoln
Jellinek, Schwartz & Connolly, Arlington, Virginia
JAMES C. CARRINGTON,
Washington State University, Pullman
REBECCA J. GOLDBURG,
Environmental Defense, New York, NY
North Carolina State University, Raleigh
North Carolina State University, Raleigh
California Department of Pesticide Regulation, Sacramento
University of Maryland, Baltimore
University of Maryland, College Park
Ohio State University, Columbus
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.
BOARD ON AGRICULTURE AND NATURAL RESOURCES
T. KENT KIRK, Chair,
University of Wisconsin, Madison
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
Iowa State University
ROBERT T. FRALEY,
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
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
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
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
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.
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.
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.
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.
National Research Council
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
risks that might be posed by transgenic breeding methods. This concern has been magnified in Europe and other parts of the world where consumer resistance has been increasing against food products produced from transgenic plants.
Concerns about the risks posed by transgenic plants have led some to question the safety review they receive in the United States under the Coordinated Regulatory Framework. Some believe that human health and environmental risks are not properly assessed. Others believe the risks are minimal, that benefits outweigh risks, and the current regulatory scheme is too onerous. This debate has intensified in recent months given the international climate and impending regulatory decisions in the United States where new regulations for transgenic plants are being considered.
Several professional societies, members of Congress, and other groups have expressed concern over the regulation of transgenic crops, citing the need for an impartial review of the present and proposed process. The National Research Council responded to this need by commissioning and funding the present study which was initiated in March 1999. The committee was charged with the following task: “The Committee will investigate risks and benefits of genetically modified pest-protected (GMPP) plants and the coordinated Regulatory Framework for Regulation of Biotechnology affecting the use of these plants. The study will (1) review the principles in the NAS Council's white paper, Introduction of Recombinant DNA-Engineered Organisms into the Environment (1987), for their continued scientific validity and assess their appropriateness for current decisions regarding GMPP plants; (2) review scientific data which addresses the risks and benefits of GMPP plants; (3) examine the existing and proposed regulations to qualitatively assess their consequences for research, development, and commercialization of GMPP plants; and (4) provide recommendations to address the identified risk/benefits, and, if warranted, for the existing and proposed regulation of GMPP plants.”
The committee was given a very short time frame and a limited budget for accomplishing this task. Committee members were identified in early spring 1999 and the first meeting was convened in April. Two later meetings followed this, one of which included a workshop in which public participation was invited. The meetings and the workshop provided the basis for the present report.
The report is composed of four chapters and an Executive Summary. Chapter 1 is an introductory chapter that discusses issues which led to the initiation of the present study, current EPA, USDA, and FDA policies, the task given to the committee by the NRC, and role of this report. Chapter 2 deals with the potential environmental and human health impacts of
pest-protected plants with risks and benefits being among the issues discussed. Chapter 3 provides several case studies related to the commercial production of transgenic genetically modified pest-protected crops, analyzes the 1994 and 1997 rules proposed by EPA for the regulation of plant-pesticides, and identifies several research needs. Chapter 4 provides an overview of the current regulation of plant products under the coordinated framework for the regulation of biotechnology by EPA, FDA, and USDA and provides recommendations that the committee believes will improve this process. The Executive Summary summarizes the key finding, conclusions, and recommendations of the report.
Because the time-frame for the conduct of the present study was very short, there were several issues of public concern that were not included in our deliberations. For example, the committee did not consider issues involving herbicide-tolerant crops or labeling of food products produced from transgenic plants. The NRC's new Standing Committee on Biotechnology, Food and Fiber Production, and the Environment will be equipped to help to identify and examine many related issues in greater detail. Also, the committee gave more consideration to the potential risks posed by the commercialization of transgenic pest-protected plants than to benefits that they might produce to farmers and the environment.
In recent months there have been many reports in the mass media concerning the negative aspects of agricultural biotechnology. Little has been said about the positive impacts that transgenic plants are having on agricultural production and environmental quality. In the future, society and regulatory authorities must find a way to balance the risks and benefits of the use of this technology in the production of food and feed crops and develop appropriate processes for their regulation. As a committee we trust that the present report will help increase our knowledge of transgenic plants and our ability to make wiser decisions concerning their regulation.
Perry L. Adkisson
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.
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
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
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
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.