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

NATIONAL RESEARCH COUNCIL OF THE NATIONAL ACADEMIES

THE NATIONAL ACADEMIES PRESS
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Animal Biotechnology: Science-Based Concerns 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 NATIONAL RESEARCH COUNCIL OF THE NATIONAL ACADEMIES THE NATIONAL ACADEMIES PRESS Washington, D.C. www.nap.edu

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Animal Biotechnology: Science-Based Concerns 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 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 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 2002 by the National Academy of Sciences. All rights reserved. Printed in the United States of America

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Animal Biotechnology: Science-Based Concerns THE NATIONAL ACADEMIES Advisers to the Nation on Science, Engineering, and Medicine 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. 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 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 chair and vice chair, respectively, of the National Research Council. www.national-academies.org

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Animal Biotechnology: Science-Based Concerns 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

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Animal Biotechnology: Science-Based Concerns 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

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Animal Biotechnology: Science-Based Concerns 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

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Animal Biotechnology: Science-Based Concerns 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

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Animal Biotechnology: Science-Based Concerns 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

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Animal Biotechnology: Science-Based Concerns 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.

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Animal Biotechnology: Science-Based Concerns 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

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Animal Biotechnology: Science-Based Concerns 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.

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Animal Biotechnology: Science-Based Concerns 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.

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Animal Biotechnology: Science-Based Concerns Contents     EXECUTIVE SUMMARY   1     Context and Background   1     Introduction   3 1   INTRODUCTION   15     Overarching Concerns of the Committee   15     The Current State of Animal Biotechnology   16     The Origins of Biotechnology in Animal Agriculture   18     Concerns Regarding Extant Technologies   22     Limits of the Report   31 2   APPLICATIONS OF BIOTECHNOLOGY TECHNIQUES   34     Introduction   34     Introduction of Novel Genes   34     Directed Genetic Manipulation   37     Propagation by Nuclear Transfer   39     Technical Issues With Germline Modification   41     Concerns Related to Germline Technology   42     Issues Related to Somatic Cell Nuclear Transfer Technology   47     Conclusions   49

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Animal Biotechnology: Science-Based Concerns 3   ANIMALS ENGINEERED FOR HUMAN HEALTH PURPOSES   51     Introduction   51     Biopharmaceutical Production   51     Xenotransplantation   54 4   FOOD SAFETY CONCERNS   61     Scope and Goal   61     Background   62     Food Products From Non-Genetically Engineered, Cloned Animals   63     Genetically Engineered Animals   65 5   ENVIRONMENTAL CONCERNS   73     General Principles of Risk Analysis   74     Prioritizing GE Animals for Level of Environmental Concern   76     Risks Posed by Key Classes of GE Animals   87     Need for More Information Concerning Risk Assessment and Risk Management   92 6   ANIMAL HEALTH AND WELFARE   93     Introduction   93     Reproductive Technologies   93     In-Vitro Culture   94     Efficiency of Production and Number of Animals Needed   96     Mutations   97     Gene Expression   98     Uniqueness of Transgenic Animals   99     Nuclear Transfer   100     Biomedical Applications   102     Farming   104     Potential Animal Welfare Benefits   105     Costs Versus Benefits   106 7   CONCERNS RELATED TO SCIENTIFIC UNCERTAINTY, POLICY CONTEXT, INSTITUTIONAL CAPACITY, AND SOCIAL IMPLICATIONS   108     Scientific Uncertainty   108     Policy Context   111     Institutional Capacity   112     Socioeconomic, Cultural, Religious, and Ethical Factors   116     The Intersection of Ethics, Science, and Public Policy   120     REFERENCES   122

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Animal Biotechnology: Science-Based Concerns     GLOSSARY   149 APPENDIX A:   WORKSHOP AGENDA   158 APPENDIX B:   REGULATORY FRAMEWORK FOR ANIMAL BIOTECHNOLOGY   161     ABOUT THE AUTHORS   166     BOARD ON AGRICULTURE AND NATURAL RESOURCES PUBLICATIONS   169     INDEX   172

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Animal Biotechnology: Science-Based Concerns Tables and Boxes TABLES 2.1   State of the Art of Transgenic Technology for Selected Organisms   39 3.1   Potential Uses of Transgenic Animals for Pharmaceutical Production   53 3.2   Applications of Xenotransplantation   55 3.3   Exogenous Pig Viruses of Concern in Xenotransplantation   57 3.4   Theoretical Scale of Risks Associated With PERV Transmission From Xenotransplants   60 5.1   Factors Contributing to Level of Concern for Species Transformed   83 BOXES 1.1   A Definition of Cloning   18 1.2   Progression of Technologies Incorporated into Modern Animal Agriculture   19 1.3   Examples of Technologies that are Experimentally Established but not Yet in Widespread Use in Animal Agriculture   22 1.4   Harms, Hazards, and Risks   33 2.1   Knockout and Knockin Technology   38 7.1   Error Bias   110 7.2   Labeling   118