ANIMAL BIOTECHNOLOGY: SCIENCE-BASED CONCERNS
THE NATIONAL ACADEMIES PRESS
Washington, D.C.
www.nap.edu
THE NATIONAL ACADEMIES PRESS
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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.
This study was supported by Contract No. 223-93-1025 between the National Academy of Sciences and the U.S. Food and Drug Administration, and funds by the National Research Council. 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.
This report has been reviewed by a group other than the authors according to procedures approved by a Report Review Committee consisting of members of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine.
Library of Congress Cataloging-in-Publication Data
Animal biotechnology: science-based concerns / Committee on Defining Science-based Concerns Associated with Products of Animal Biotechnology, Committee on Agricultural Biotechnology, Health, and the Environment, Board on Agriculture and Natural Resources, Board on Life Sciences, Division on Earth and Life Studies.
p. cm.
Includes bibliographical references and index.
ISBN 0-309-08439-3 (pbk.)
1. Animal biotechnology. I. National Research Council (U.S.). Committee on Defining Science-based Concerns Associated with Products of Animal Biotechnology.
SF140.B54 A58 2002
660'.65—dc21
2002151075
Additional copies of this report are available from the
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Committee on Defining Science-Based Concerns Associated with Products of Animal Biotechnology
JOHN G. VANDENBERGH, Chair,
North Carolina State University, Raleigh
ALWYNELLE (NELL) SELF AHL,
Tuskegee University
JOHN M. COFFIN,
Tufts University School of Medicine
WILLARD H. EYESTONE,
Virginia-Maryland Regional College of Veterinary Medicine
ERIC M. HALLERMAN,
Virginia Polytechnic and State University, Blacksburg
TUNG-CHING LEE,
Rutgers University
JOY A. MENCH,
University of California, Davis
WILLIAM M. MUIR,
Purdue University
R. MICHAEL ROBERTS,
University of Missouri, Columbia
THEODORE H. SCHETTLER,
Science and Environmental Health Network
LAWRENCE B. SCHOOK,
University of Illinois, Urbana
MICHAEL R. TAYLOR,
Resources for the Future
Staff
KIM WADDELL, Study Director
DEBRA DAVIS, Editor
MICHAEL R. KISIELEWSKI, Research Assistant
CINDY LOCHHEAD, Project Assistant
Committee on Agricultural Biotechnology, Health, and the Environment
BARBARA A. SCHAAL, Chair,
Washington University, St. Louis, MO
DAVID A. ANDOW,
University of Minnesota, St. Paul
NEAL L. FIRST,
University of Wisconsin, Madison
LYNN J. FREWER,
Institute of Food Research, Norwich, UK
HENRY L. GHOLZ,
National Science Foundation, Arlington, VA
EDWARD GROTH III,
Consumers Union, Yonkers, NY
ERIC M. HALLERMAN,
Virginia Polytechnic Institute and State University, Blacksburg
RICHARD R. HARWOOD,
Michigan State University, East Lansing
CALESTOUS JUMA,
Harvard University, Cambridge, MA
SAMUEL B. LEHRER,
Tulane University School of Medicine, New Orleans, LA
SANFORD A. MILLER,
Georgetown University, Washington, DC
PHILIP G. PARDEY,
University of Minnesota, St. Paul
PER PINSTRUP-ANDERSEN,
International Food Policy Research Institute, Washington, DC
ELLEN K. SILBERGELD,
Johns Hopkins University, Baltimore, MD
ROBERT E. SMITH,
R. E. Smith Consulting, Inc., Newport, VT
ALLISON A. SNOW,
Ohio State University, Columbus
PAUL B. THOMPSON,
Purdue University, West Lafayette, IN
DIANA H. WALL,
Colorado State University, Fort Collins
Staff
JENNIFER KUZMA, Program Director
SETH STRONGIN, Project Assistant
Board on Agriculture and Natural Resources
HARLEY W. MOON, Chair,
Iowa State University
SANDRA BARTHOLMEY,
Quaker Oats Company
DEBORAH BLUM,
University of Wisconsin, Madison
ROBERT B. FRIDLEY,
University of California
BARBARA P. GLENN,
Federation of Animal Science Societies
LINDA F. GOLODNER,
National Consumers League
W.R. (REG) GOMES,
University of California
PERRY R. HAGENSTEIN,
Institute for Forest Analysis, Planning, and Policy
CALESTOUS JUMA,
Harvard University
JANET C. KING,
University of California, Davis
WHITNEY MACMILLAN,
Cargill, Inc.
PAMELA A. MATSON,
Stanford University
TERRY L. MEDLEY,
DuPont Biosolutions Enterprise
JAMES A. MERCHANT,
University of Iowa
ALICE N. PELL,
Cornell University
SHARRON S. QUISENBERRY,
Montana State University
NANCY J. RACHMAN,
Exponent, Inc.
SONYA B. SALAMON,
University of Illinois
G. EDWARD SCHUH,
University of Minnesota
BRIAN J. STASKAWICZ,
University of California, Berkeley
JACK WARD THOMAS,
University of Montana
JAMES H. TUMLINSON,
USDA/ARS
B.L. TURNER,
Clark University
Staff
CHARLOTTE KIRK BAER, Director
STEPHANIE PADGHAM, Project Assistant
Board on Life Sciences
COREY S. GOODMAN, Chair,
University of California, Berkeley
R. ALTA CHARO,
University of Wisconsin, Madison
JOANNE CHORY,
The Salk Institute for Biological Studies
DAVID J. GALAS,
Keck Graduate Institute of Applied Life Sciences
BARBARA GASTEL,
Texas A&M University, College Station
JAMES M. GENTILE,
Hope College
LINDA E. GREER,
Natural Resources Defense Council
ED HARLOW,
Harvard Medical School
ELLIOT M. MEYEROWITZ,
California Institute of Technology, Pasedena
ROBERT T. PAINE,
University of Washington, Seattle
GREGORY A. PETSKO,
Brandeis University
STUART L. PIMM,
Columbia University
JOAN B. ROSE,
University of South Florida, St. Petersburg
GERALD M. RUBIN,
Howard Hughes Medical Institute
BARBARA A. SCHAAL,
Washington University
RAYMOND L. WHITE,
University of Utah, Salt Lake City
Staff
FRANCES SHARPLES, Director
BRIDGET AVILA, Senior Project Assistant
Preface
What we have before us are some breathtaking opportunities disguised as insoluble problems.
—John W. Gardner, 1965, upon appointment as the Secretary of the Department of Health, Education, and Welfare
Rarely in the modern history of humans has biology played such an important role in human affairs as it does today. In the eighteenth and nineteenth centuries, explorers stimulated the first major advance in biology by bringing back countless new species that Darwin, and others, put into a logical order based on the theory of natural selection. The development of evolutionary thinking and the clarification of the rules of genetic inheritance resulted in the theoretical base for targeted artificial selection—an essential component of progress in biology and agriculture.
A second major advance currently is underway. Due to the basic understanding of inheritance at the molecular level and the tools this has made available to biologists, it no longer is necessary to depend upon natural or artificial selection and breeding of progeny to produce new and improved individuals. Genes from the same or other species can be inserted into a genome, or the activity of a specific gene can be blocked. Further, once the genome has been altered artificially, large numbers of new plants and animals
carrying the modified genome can be made using cloning techniques. Producing animal models of human diseases for research, improving medical procedures, and increasing food production are but three modern advances that already have come to pass. More advances are predicted for the future. The committee— early in its discussions—recognized that not everything that bloomed from the biotechnology garden was a flower ready to be picked for the human bouquet. As was true for other technologic advances in the past, advances do not come without expected and unexpected risks. The committee also recognized that the technology it was studying is in its infancy. Many of the problems, such as inefficient reproduction and production of abnormal offspring, are receding as the technology advances. Therefore, the committee presents a “snapshot” of biotechnology and of potential concerns about that technology at present.
In view of the rapidly-changing biotechnologic landscape, federal agencies with responsibility for ensuring food safety, maintaining modern medical treatment standards, minimizing environmental impacts, and ensuring the welfare of animals requested that a committee formed by the National Research Council (NRC) of the National Academies explore concerns related to animal biotechnology. A committee of 12 scientists, physicians, and experts in regulatory issues accepted the task of defining science-based concerns associated with products of animal biotechnology. The committee’s report presents science-based concerns it identified but it does not contain specific recommendations. Identification of the concerns will allow others to develop regulatory policy where appropriate. While the focus of the committee was on the scientific information that could clarify the issues, it remained aware of the social and other policy issues involved in moving biotechnologic advances from the laboratory to the “real world.” Thus, assuming a bit of flexibility in our charge, our report addresses some of the policy issues involved as well.
In a sense, almost any issue related to a technologic advance can be a concern. The committee attempted to place concerns in relative priority order within sections of the report (i.e., hazards associated with the techniques themselves, food safety, environmental impacts, and animal welfare). In only a few cases was it possible to state that an issue brought to our table was not of concern. Much of the basic biology underlying the techniques remains to be discovered, and we have only partial information on the consequences of using biotechnologic techniques. This is true especially in terms of the environmental concerns raised. It became quickly apparent that more information was needed to assess the priority of concerns raised. Only more research will resolve this problem.
The committee relied heavily on published information, on presentations made by experts at an NRC-sponsored workshop, and on previous NRC reports. The NRC report, Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation—recently completed by experts from the botanical half of the biologic world—was a valuable source of information.
This is an especially opportune time to explore the concerns related to animal biotechnology. The field has progressed to the point where we already have seen applications of this science to our daily lives, and might see many more. The committee hopes that our discussions, as reflected in this report, will inform government agencies and the public of the major scientific issues involved so that this technology can be applied as safely as possible without denying the public its benefits.
This study and the resulting report would not have been possible without the dedication, skill, and hard work of the study director, Dr. Kim Waddell, and research assistant, Michael Kisielewski, of the Board on Agriculture and Natural Resources of the National Academies.
JOHN G. VANDENBERGH, Chair
Committee on Defining Science-based Concerns Associated with Products of Animal Biotechnology
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 workshop:
MICHAEL D. BISHOP, Infigen, Inc., DeForest, WI
KEITH H. S. CAMPBELL, University of Nottingham, Loughborough, UK
JOSÉ B. CIBELLI, Advanced Cell Technology, Worcester, MA
JEAN FRUCI, The Pew Initiative on Food and Biotechnology, Washington, DC
PERRY B. HACKETT, Discovery Genomics, Inc., Minneapolis, MN
MICHAEL K. HANSEN, Consumer Policy Institute, Yonkers, NY
MARJORIE A. HOY, University of Florida, Gainesville
SAMUEL B. LEHRER, Tulane University Medical Center, New Orleans, LA
LARISA RUDENKO, Integrative Biostrategies, LLC, Washington, DC
PAUL B. THOMPSON, Purdue University, West Lafayette, IN
ROBERT J. WALL, United States Department of Agriculture Research Center, Beltsville, MD
The committee extends its appreciation to the staff members of the National Research Council’s (NRC) Division on Earth and Life Studies, Board on Agriculture and Natural Resources, and Board on Life Sciences 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 perspectives 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 wish to thank the following individuals for their review of this report:
ROY CURTISS III, Washington University, St. Louis, MO
REBECCA GOLDBURG, Environmental Defense, New York, NY
THOMAS J. HOBAN IV, North Carolina State University, Raleigh
ANNE R. KAPUSCINSKI, University of Minnesota, St. Paul
SANFORD A. MILLER, Center for Food and Nutrition Policy, Washington, DC
JAMES D. MURRAY, University of California, Davis
LARISA RUDENKO, Integrative Biostrategies, LLC, Washington, DC
PAUL B. THOMPSON, Purdue University, West Lafayette, IN
MARK E. WESTHUSIN, Texas A&M University, College Station
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 Donald D. Brown, Carnegie Institution of Washington, Baltimore, MD, and George E. Seidel, Jr., Colorado State University, Fort Collins. 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.
Tables and Boxes
TABLES
2.1 |
State of the Art of Transgenic Technology for Selected Organisms |
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3.1 |
Potential Uses of Transgenic Animals for Pharmaceutical Production |
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3.2 |
Applications of Xenotransplantation |
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3.3 |
Exogenous Pig Viruses of Concern in Xenotransplantation |
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3.4 |
Theoretical Scale of Risks Associated With PERV Transmission From Xenotransplants |
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5.1 |
Factors Contributing to Level of Concern for Species Transformed |
BOXES
1.1 |
A Definition of Cloning |
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1.2 |
Progression of Technologies Incorporated into Modern Animal Agriculture |
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1.3 |
Examples of Technologies that are Experimentally Established but not Yet in Widespread Use in Animal Agriculture |
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1.4 |
Harms, Hazards, and Risks |
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2.1 |
Knockout and Knockin Technology |
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7.1 |
Error Bias |
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7.2 |
Labeling |