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Committee on Biological Confinement of Genetically Engineered Organisms
Board on Agriculture and Natural Resources
Board on Life Sciences
Division on Earth and Life Studies
THE NATIONAL ACADEMIES PRESS
Washington, DC
www.nap.edu
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THE NATIONAL ACADEMIES PRESS 500 Fifth Street, N.W. Washington, DC 20001
NOTICE: The project that is the subject of this report was approved by the Govern-
ing Board of the National Research Council, whose members are drawn from the
councils of the National Academy of Sciences, the National Academy of Engineer-
ing, 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 Agreement No. 59-0790-1-182 between the National
Academy of Sciences and the U.S. Department of Agriculture. Any opinions, find-
ings, 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
Biological confinement of genetically engineered organisms / Committee on Biologi-
cal Confinement of Genetically Engineered Organisms, Board on Agriculture and
Natural Resources, Board on Life Sciences, Division on Earth and Life Studies.
p. cm.
Includes bibliographical references and index.
ISBN 0-309-09085-7 (hardcover)--ISBN 0-309-52778-3 (pdf)
1. Transgenic organisms--Safety measures. 2. Confinement farms. 3. Agricultural
biotechnology. 4. Infertility in animals. 5. Transgenic organisms--Risk assessment.
I. National Research Council (U.S.). Committee on Biological Confinement of Ge-
netically Engineered Organisms.
QH442.6.B54 2004
577'.18--dc22
2004004051
Additional copies of this report are available from the National Academies Press,
500 Fifth Street, N.W., Lockbox 285, Washington, DC 20055; (800) 624-6242 or
(202) 334-3313 (in the Washington metropolitan area); Internet, http://www.nap.edu
Copyright 2004 by the National Academy of Sciences. All rights reserved.
Printed in the United States of America
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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 Acad-
emy 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 engi-
neers. 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 engineer-
ing 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 Sci-
ences 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 con-
gressional charter to be an adviser to the federal government and, upon its own
initiative, to identify issues of medical care, research, and education. Dr. Harvey V.
Fineberg 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 gov-
ernment, 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 chair and vice chair, respectively, of the National
Research Council.
www.national-academies.org
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COMMITTEE ON BIOLOGICAL CONFINEMENT OF
GENETICALLY ENGINEERED ORGANISMS
T. KENT KIRK, Chair, University of Wisconsin, Madison
JOHN E. CARLSON, Pennsylvania State University, University Park
NORMAN ELLSTRAND, University of California, Riverside
ANNE R. KAPUSCINSKI, University of Minnesota, St. Paul
THOMAS A. LUMPKIN, Asian Vegetable Research and Development
Center, Shanhua, Taiwan
DAVID C. MAGNUS, Stanford University, Palo Alto, California
DANIEL B. MAGRAW, JR., Center for International Environmental Law,
Washington, DC
EUGENE W. NESTER, University of Washington, Seattle
JOHN J. PELOQUIN, American Protein Corporation, Inc., Ames, Iowa
ALLISON A. SNOW, The Ohio State University, Columbus
MARIAM B. STICKLEN, Michigan State University, East Lansing
PAUL E. TURNER, Yale University, New Haven, Connecticut
STAFF
KIM WADDELL, Study Director
MICHAEL KISIELEWSKI, Research Assistant
PETER RODGERS, Research Intern
DONNA WILKINSON, Research Intern
ANNE H. KELLY, Editor
CINDY LOCHHEAD, Project Assistant
JULIE COFFIN, Project Assistant
v
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COMMITTEE ON AGRICULTURAL BIOTECHNOLOGY,
HEALTH, AND THE ENVIRONMENT
BARBARA SCHAAL, Chair, Washington University, St. Louis, Missouri
DAVID ANDOW, University of Minnesota, St. Paul
FREDERICK AUSUBEL, Harvard Medical School, Boston, Massachusetts
NEAL FIRST, University of Wisconsin, Madison
LYNN FREWER, Institute of Food Research, Norwich, United Kingdom
HENRY GHOLZ, National Science Foundation, Arlington, Virginia
EDWARD GROTH, Consumers Union, Yonkers, New York
ERIC HALLERMAN, Virginia Polytechnic Institute and State University,
Blacksburg
RICHARD HARWOOD, Michigan State University, East Lansing
CALESTOUS JUMA, Harvard University, Cambridge, Massachusetts
SAMUEL LEHRER, Tulane University, New Orleans, Louisiana
SANFORD MILLER, Center for Food and Nutrition Policy, Virginia
Polytechnic Institute and State University, Alexandria
PHILIP PARDEY, University of Minnesota, St. Paul
PER PINSTRUP-ANDERSON, Cornell University, Ithaca, New Yor
ELLEN SILBERGELD, Johns Hopkins Bloomberg School of Public Health,
Baltimore, Maryland
ROBERT SMITH, R.E. Smith Consulting, Inc., Newport, Vermont
ALLISON SNOW, Ohio State University, Columbus
PAUL THOMPSON, Michigan State University, East Lansing
DIANA WALL, Colorado State University, Fort Collins
vi
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BOARD ON AGRICULTURE AND NATURAL RESOURCES
MAY BERENBAUM, Chair, University of Illinois, Urbana
SANDRA BARTHOLMEY, University of Illinois, Chicago
DEBORAH BLUM, University of Wisconsin, Madison
H. H. CHENG, University of Minnesota, St. Paul
BARBARA P. GLENN, Biotechnology Industry Organization,
Washington, DC
LINDA F. GOLODNER, National Consumers League, Washington, DC
W. R. (REG) GOMES, University of California, Oakland
PERRY R. HAGENSTEIN, Institute for Forest Analysis, Planning, and
Policy, Wayland, Massachusetts
JANET C. KING, Children's Hospital Oakland Research Center, Oakland,
California
DANIEL P. LOUCKS, Cornell University, Ithaca, New York
WHITNEY MACMILLAN, Cargill, Inc., Minneapolis, Minnesota
TERRY L. MEDLEY, DuPont Agriculture and Nutrition, Wilmington,
Delaware
OLE NIELSEN, Ontario Veterinary College, Canada
ALICE N. PELL, Cornell University, Ithaca, New York
BOBBY PHILLS, Florida A&M University, Tallahassee
SHARRON S. QUISENBERRY, Virgnia Polytechnic and State University,
Blacksburg
SONYA B. SALAMON, University of Illinois at Urbana-Champaign,
Urbana
G. EDWARD SCHUH, Humphrey Institute of Public Affairs, Minneapolis,
Minnesota
BRIAN J. STASKAWICZ, University of California, Berkeley
JACK WARD THOMAS, University of Montana, Missoula
JAMES H. TUMLINSON, Pennsylvania State University, University Park
B. L. TURNER, Clark University, Worcester, Massachusetts
STAFF
CHARLOTTE KIRK BAER, Director
KAREN IMHOF, Administrative Assistant
vii
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BOARD ON LIFE SCIENCES
COREY S. GOODMAN, Chair, University of California, Berkeley
RUTH BERKELMAN, Emory University, Atlanta
R. ALTA CHARO, University of Wisconsin, Madison
DENNIS CHOI, Merck Research Laboratories, West Point, Pennsylvania
JOANNE CHORY, The Salk Institute for Biological Studies, La Jolla,
California
JEFFREY L. DANGL, University of North Carolina, Chapel Hill
PAUL R. EHRLICH, Stanford University, Palo Alto, California
JAMES M. GENTILE, Hope College, Holland, Michigan
LINDA GREER, Natural Resources Defense Council, Washington, DC
ED HARLOW, Harvard Medical School, Cambridge, Massachusetts
DAVID HILLIS, University of Texas, Austin
KENNETH F. KELLER, University of Minnesota, Minneapolis
RANDALL MURCH, Institute for Defense Analyses, Alexandria, Virginia
GREGORY A. PETSKO, Brandeis University, Waltham, Massachusetts
STUART L. PIMM, Duke University, Durham, North Carolina
BARBARA A. SCHAAL, Washington University, St. Louis, Missouri
JAMES TIEDJE, Michigan State University, East Lansing
KEITH YAMAMOTO, University of California, San Francisco
STAFF
FRANCES SHARPLES, Director
DENISE GROSSHANS, Senior Project Assistant
viii
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Acknowledgments
This report represents the integrated efforts of many individuals. The
committee thanks all those who shared their insight and knowledge to bring
the document to fruition. We also thank all those who provided information
at our public meetings and who participated in our public sessions.
During the course of its deliberations, the committee sought assistance
from several people who gave generously of their time to provide advice and
information that were considered in its deliberations. Special thanks are due
the following:
WILLY DE GREEF, Syngenta Seeds, Basel, Switzerland
CATHLEEN ENRIGHT, APHIS / USDA, Riverdale, Maryland
PHILIP J. EPPARD, Monsanto Protein Technologies, St. Louis,
Missouri
PAL MALIGA, Rutgers University, Piscataway, New Jersey
MICHAEL H. PAULY, Epicyte Pharmaceutical, Inc., San Diego,
California
JANE RISSLER, Union of Concerned Scientists, Washington, DC
MICHAEL SCHECHTMAN, USDA, Washington, DC
ANTHONY M. SHELTON, Cornell University, Geneva, New York
STEVEN H. STRAUSS, Oregon State University, Corvallis, Oregon
The committee is grateful to members of the National Research Council
(NRC) staff who worked diligently to maintain progress and quality in its
work. We also would like to thank Robert McDonald, Melissa Brandt, Sarah
De Belen, Tazeen Hasan, and Rene Milet for their research assistance.
ix
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x ACKNOWLEDGMENTS
This report has been reviewed in draft form by individuals chosen for
their diverse perspectives and technical expertise, in accordance with proce-
dures approved by the National Research Council's Report Review Com-
mittee. 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 wish to thank the following
individuals for their review of this report:
DAVID ADELMAN, University of Arizona College of Law, Tucson,
Arizona
KLAUS AMMANN, University of Bern, Bern, Switzerland
R. JEFFREY BURKHARDT, University of Florida, Gainesville, Florida
JEFFREY DANGL, The University of North Carolina, Chapel Hill,
North Carolina
DONALD N. DUVICK, Iowa State University, Ames, Iowa
VIRGINIA S. HINSHAW, University of California, Davis, California
CALESTOUS JUMA, Harvard University, Cambridge, Massachusetts
STEVEN E. LINDOW, University of California, Berkeley, California
TERRY MEDLEY, DuPont Agriculture and Nutrition, Wilmington,
Delaware
WILLIAM MUIR, Purdue University, West Lafayette, Indiana
CHRISTOPHER SOMERVILLE, Stanford University, Stanford,
California
STEVEN STRAUSS, Oregon State University, Corvallis, Oregon
GREG TRAXLER, Auburn University, Auburn, Alabama
Although the reviewers listed 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 Dr. Robert A. Frosch,
Harvard University, Cambridge, Massachusetts, and Dr. Fred Gould, North
Carolina State University, Raleigh. Appointed by the National Research
Council, they were responsible for making certain that an independent ex-
amination of this report was carried out in accordance with institutional
procedures and that all review comments were carefully considered. Re-
sponsibility for the final content of this report rests entirely with the
authoring committee and the institution.
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Preface
Genetically engineered microbes have been used commercially for many
years to make products useful to humans. Production is confined to vessels
that are sterilized between batches. There has been little concern about these
genetically engineered (GE) microbes escaping into the wild and doing
damage, in part because they are confined physically and in part because
they are weakened by foreign genetic material that makes them unlikely to
survive in the wild.
But 10 years ago genetically engineered crop plants were introduced
into field environments, a situation quite different from having GE microbes
in fermentors. This outplanting of GE plants raised, and continues to raise,
public and scientific concerns on the potential consequences of escape of
genetically engineered organisms (GEOs) and their associated transgenes
into natural and managed ecosystems. The acreage planted with GE crop
plants has steadily and rapidly increased, as have the number of types of GE
plants. GE fish and other animals have now been developed, some with
remarkable potentials. This increased use and development of new GEOs
obviously reflects the fact that GEOs can have substantial advantages over
their progenitors. Agricultural biotechnology has enormous potential to
better the human condition. However, concern about the possible risks posed
by some GEOs has led to questions about the regulation they receive, and
has increased interest in assuring that certain GEOs are confined. While no
serious consequences have ensued because of a failure of GEO confinement,
with the growing diversity and number of GEOs being developed and
released, the potential for unwanted consequences increases, and scientists
can envision undesirable scenarios.
xi
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xii PREFACE
Confinement can be accomplished not only by physical but also by bio-
logical means. Several examples of long-used biological confinement
methods (used with non-GEOs) are described in this report. Genetic engi-
neering, however, makes new biological confinement strategies possible. We
refer to all biological confinement methods, whether genetically engineered
or not, as bioconfinement methods.
The NRC convened a committee of 12 members from a variety of
complementary specialties; the reader is urged to read the brief biographical
sketches. Members were selected who could not only cover the different
aspects of bioconfinement, but who could also assure a flexible view of the
committee's charge and provide overall and realistic balance.
Our task was challenging. Bioconfinement of GEOs is in its infancy as a
focused science. But the science is fast-moving, rapidly evolving. We found
ourselves dealing with a lack of published data on many of the existing and
potential methods. Entirely new methods of bioconfinement were announced
by the scientific community while we worked on the report. Consequently,
we did not focus exclusively on methods in commercial use but tried to
anticipate future developments. An exhaustive literature search was not part
of our charge; only a few illustrative examples were provided for each
confinement approach. Our statement of task of six questions (see the Execu-
tive Summary and Chapter 1) limited us further because effective bio-
confinement will require more than sound science. It will require safe
practices and commitment by those who design and develop the GEOs;
effective regulatory oversight; a public commitment to investing in this tech-
nology; a high level of public confidence and acceptance; effective commu-
nication between stakeholders; respect for regional and cultural differences
in values, experience, ethics; recognition of the international dimensions;
and more.
We met four times, for a total of about eight days. Most of the research
and writing was done individually between meetings, so that the meetings
could be devoted to critique and improvement. We began with presentations
by and discussions with the sponsoring agency and outside experts from
industry, academia, and nongovernmental organizations (NGOs). We then
prepared a report outline which was continuously revised, and wrote the
report via numerous iterations. This report is a consensus document. Each
committee member had the opportunity to question and modify the content
of each paragraph. We all learned in this process. The procedure resulted in
improvements in every section. In-depth reviews by outside experts from
academia and industry resulted in further improvements in the report's
clarity, balance, and presentation.
Chapter 1 provides an introduction to the subject, gives the scope of the
study, provides a brief history of GEOs and their confinement, and gives an
introduction into ethical and other social considerations. The committee
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PREFACE xiii
recognized that many GEOs will not warrant confinement. We therefore
addressed the issue of when and why bioconfinement might be necessary
and described briefly some of the possible undesirable consequences of
escape of some GEOs (Chapter 2). Chapters 3, 4, and 5 detail what is
presently known about bioconfinement methodologies for plants, animals,
and microbes (and fungi and viruses), respectively. Chapter 6 summarizes
the biological and operational considerations for bioconfinement and points
to some important research needs.
Serving as chair of this committee was a most interesting and enlighten-
ing experience for me personally. Bioconfinement is not my field, nor is
genetic engineering, so I was afforded significant learning opportunities. At
the outset I was surprised at the breadth of subject matter that "bio-
confinement of GEOs" invites. This is especially true since we considered
plants, animals and microbes. It is my hope, that we have written a report
that not only will be valuable to the sponsoring agency and other stake-
holders, but also one that reflects the committee's concerted effort to
adequately characterize a rapidly evolving and complex subject in a National
Academies' report. I also hope that our efforts contribute much to the
ongoing discussion about biotechnology and the opportunities to utilize the
biological tools available to minimize the concerns and risks surrounding
the release of GEOs into the environment. Most of all, I hope readers enjoy
what we have prepared.
I want to thank the committee members sincerely for their participation
and hard work; they are all busy people, and NRC work is pro bono. We all
thank our NRC study director, Dr. Kim Waddell, for his excellent leader-
ship, and we thank his staff of Julie Coffin, Michael Kisielewski, Cindy
Lochhead, Peter Rodgers, and Donna Wilkinson.
T. Kent Kirk, Chair
Committee on Biological Confinement
of Genetically Engineered Organisms
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Contents
EXECUTIVE SUMMARY 1
Rationale for Bioconfinement, 3
Methods of Bioconfinement, 4
Ensuring Bioconfinement Efficacy, 6
Detecting and Mitigating Bioconfinement Failure, 10
Ecological Consequences of Large-Scale Use of Bioconfinement, 11
Conclusions, 12
1 INTRODUCTION 14
What Are Genetically Engineered Organisms?, 14
What is Bioconfinement?, 15
Other Confinement Methods,16
Scope of the Report, 17
International Aspects, 19
History of Confinement, 19
Social Acceptability of Bioconfinement Methods, 25
2 WHEN AND WHY TO CONSIDER BIOCONFINEMENT 29
Introduction, 29
What is Risk?, 30
Concerns, 35
Effects on Nontarget Species, 52
Delaying the Evolution of Resistance, 52
Food Safety and Other Issues, 53
When and Why to Consider Bioconfinement: The Need for
Preventive Actions, 53
xv
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xvi CONTENTS
How Much Confinement Is Enough?, 54
Need for Bioconfinement, 55
Predicting the Consequences of Failure, 56
Who Decides, 58
3 BIOCONFINEMENT OF PLANTS 65
Methods of Bioconfinement, 65
Genetically Engineered Trees, 98
Transgenic Grasses, 115
Transgenic Algae, 121
Effectiveness at Different Spatial and Temporal Scales, 122
Monitoring and Managing Confinement Failure, 124
4 BIOCONFINEMENT OF ANIMALS: FISH, SHELLFISH,
AND INSECTS 130
Bioconfinement of Fish and Shellfish, 132
Bioconfinement of Insects, 153
5 BIOCONFINEMENT OF VIRUSES, BACTERIA, AND
OTHER MICROBES 159
Introduction, 159
Potential Effects or Concerns, and Need for Bioconfinement in
Viruses, Fungi, and Bacteria, 160
Bioconfinement of Bacteria, Viruses, and Fungi, 169
6 BIOLOGICAL AND OPERATIONAL CONSIDERATIONS
FOR BIOCONFINEMENT 180
What Biology Tells Us about Confinement and
Bioconfinement, 180
Execution of Confinement, 185
International Aspects, 193
Bioconfinement Failure, 194
Looking to the Future: Strategic Public Investment in
Bioconfinement Research, 195
REFERENCES 199
ABOUT THE AUTHORS 235
BOARD ON AGRICULTURE AND NATURAL RESOURCES
PUBLICATIONS 241
INDEX 245
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Tables, Figures, and Boxes
TABLES
2-1 Systematic Risk Assessment and Management, 33
2-2 Genetically Engineered Organisms, 39
3-1 Bioconfinement Methods in Plants, 66
3-2 Genetically Engineered Woody Plants, Permits Approved by APHIS
for Field Tests in the United States, 19892003, 99
3-3 Genetically Engineered Turfgrasses, Permits Approved by APHIS for
Field Tests in the United States, 19932003, 116
4-1 Genetic Bioconfinement Strategies for Fish, 147
4-2 Insects Subjected to the Sterile Insect Technique, 155
FIGURES
2-1 A Risk Assessment Matrix, 32
3-1 Proposed Transgenic Bioconfinement Methods in Plants, 73
3-2 Repressible Seed--Lethal Bioconfinement, 86
3-3 A Wild Hybrid, F. arundinacea and L. multiflorum Lam, 119
4-1 Normal Steps in Gamete Fertilization and Early Cell Division, 134
4-2 Production Cycle for All-Female Lines of Fish in Species with an XY
Sex Determination System, 143
xvii
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xviii TABLES, FIGURES, AND BOXES
BOXES
2-1 Confinement Failure: StarLink Corn, 34
3-1 Stability of Transgenic Confinement, 102
3-2 When Will Bioconfinement be Necessary for Trees?, 105
3-3 Turfgrass Might be Difficult to Confine, 120
4-1 Proposed Bioconfinement of Transgenic Atlantic Salmon, 137
5-1 1776, 172
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