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AGRICULTURAL BIOTECHNOLOGY Strategies for National Compefitiveness Committee on a National Strategy for Biotechnology in Agriculture Board on Agriculture National Research Council NATIONAL ACADEMY PRESS Washington, D.C. 1987

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NATIONAL ACADEMY PRESS ~ 2101 Constitution Ave.' NW ~ Washington, DC 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 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. The National Academy of Sciences is a private, nonprofit, self-perpetuating society a{ 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. F`rank Press is president of the National Academy of Sciences. The National Academy of Engineering was established in 19G4, 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. Robert M. White 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. Samuel O. Thier 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. Frank Press and Dr. Robert M. White are chairman and vice chairman, respectively, of the National Research Council. Support for this project was provided by grants from the Agricultural Research Service of the U.S. Department of Agriculture and by contributions from the Foundation for Agronomic Research and the Richard Lounsbery Foundation. It also has received support from the National Research Council Fund, a pool of private, discretionary, nonfederal funds that is used to support a program of Academy- initiated studies of national issues in which science and technology figure significantly. The NRC Fund consists of contributions from a consortium of private foundations including the Carnegie Corporation of New York, the Charles E. Culpeper Foundation, the William and Flora Hewlett Foundation, the John D. and Catherine T. MacArthur Foundation, the Andrew W. Mellon Foundation, the Rockefeller Foundation, and the Alfred P. Sloan Foundation; the Academy Industry Program, which seeks annual contributions from companies that are concerned with the health of U.S. science and technology and with public policy issues with technological content; and the National Academy of Sciences and the National Academy of Engineering endowments. Library of Congress Cataloging-in-Publication Data National Research Council (U.S.). Committee on a National Strategy for Biotechnology in Agriculture. Agricultural biotechnology. Bibliography: p. Includes index. 1. Agricultural biotechnology-United States. 2. Agricultural biotechnology-Government policy-United States. 3. Agriculture-Research-United States. 4. Agricultural-Research-United States. I. Title. S494.5.B563N37 1987 631.3'0973 87-12181 ISBN 0-309-0-3745-X Printed in the United States of America First Printing, May 1987 Second Printing, August 1987 Third Printing, October 1987 Fourth Printing, June 1988

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COMMITTEE ON A NATIONAL STRATEGY FOR BIOTECHNOLO GY IN AGRICULTURE CHARLES E. HESS (Chairman), University of California at Davis RANDOLPH BARKER, Cornell University LAWRENCE BOGORAD, Harvard University RALPH E. CHRISTOFFERSEN, The Upjohn Company ALBERT H. ELLINGBOE, University of Wisconsin ANTHONY FARAS, Molecular Genetics, Inc., and University of Minnesota JACK GORSKI, University of Wisconsin HAROLD D. HAPS, Merck, Sharp & Dohme Research Laboratories LOWELL LEWIS, California Agricultural Experiment Station BORIS MAGASANIK, Massachusetts Institute of Technology LOIS K. MILLER, University of Georgia KATHLEEN P. MULLINIX, Columbia University ROGER SALQUIST, Calgene, Inc. DANIEL I. C. WANG, Massachusetts Institute of Technology Staff JAMES E. TAVARES, Project Officer PHYLLIS B . MOSES, Staff Officer SUSANNE E. MASON, Administrative Secretary - 111

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BOARD ON AGRICULTURE WILLIAM L. BROWN {Chairman), Pioneer Hi-Bred International, Inc. JOHN A. PING (Vice Chairman), National Research Council PERRY L. ADKISSON, Texas A&M University C. EUGENE ALLEN, University of Minnesota EDWIN H. CLARK II,* The Conservation Foundation ELLIS B. COWLING,* North Carolina State University JOSEPH P. FONTENOT, Virginia Polytechnic Institute and State University ROBERT M. GOODMAN, CaIgene, Inc. RALPH W. F. HARDY, Boyce Thompson Institute, and BioTechnica International, Inc. ROGER L. MITCHELL,l University of Missouri CHARLES C. MUSCOPLAT, Molecular Genetics, Inc. KARL H. NORRIS'* U.S. Department of Agriculture, Beltsville, Md. ; ELDER A. PAUL,l Michigan State University VERNO N W . RUTTAN, University of Minnesota CHAMP B. TANNER,* University of Wisconsin JAMES G. TEER,l Welder Wildlife Foundation THOMAS D. TRAUTMAN, General Mills, Inc. JAN VAN SCHILFGAARDE, U.S. Department of Agriculture Fort Collins, Colo. VIRGINIA WALBOT, Stanford University CONRAD J. WEISER, Oregon State University CHARLES M. BENBROOK, Executive Director JAMES E. TAVARES, Associate Executive Director CARLA CARLSON, Reports Officer and Senior Editor GRACE JONES ROBBINS, Assistant Editor *Term began January 1, 1987 tTerm ended December 31, 1986 1V

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Preface The breakthroughs in science that permitted genes, and thus heredity, to be identified and manipulated as molecules ushered in the biotechnology era, which is now more than a decade old. The new tools of biotechnology are changing the way scientists can address problems in the life sciences; agriculture is one area facing major changes as a result of this new technology. The unanticipated rapid rate at which discoveries and their applica- tions in biotechnology have unfolded has stressed the capacity of society more specifically, our agricultural research and ed- ucational institutions to absorb and adjust to change. We are challenged by pressing decisions, opportunities, and problems that we face now and will continue to face in the future. Competition from abroad impels us to devise and use new technologies that can improve the efficiency and quality of U.S. agricultural production. These concerns led to this study an overview of how the agricul- tural research system is responding to biotechnology and how it might prepare for future opportunities. The Board on Agriculture initiated this study to explore ways of accelerating the benefits of biotechnology within the U.S. agri- cultural economy. Support was sought from the National Research Council Fund and the U.S. Department of Agriculture, which also requested a study of public and private sector interactions in biotechnology research. Our committee was asked to examine the activities and issues that biotechnology was generating in re- search and practical applications, and to recommend strategies v

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V1 PREFACE by which agriculture might respond to and benefit from these changes. Specifically, the mandate to our committee was to assess . applications of biotechnology for improving the efficiency of agricultural practice; the capacity of existing institutions and programs to train and retrain scientists and carry out research in agricultural biotechnology; models and approaches for fostering interdisciplinary research combining the interests and talents of molecular biologists with those of scientists in traditional agricultural disciplines; and the role of new interactions for scientific exchange and technol- ogy transfer between the private sector and publicly supported research and educational institutions. Biotechnology is moving in many directions with positive results crop improvement, vaccine development, and diagnostic methods are some impending applications- but the development of biotechnology's tools can be found in almost every agricultural discipline. Advances are confined more by the limits of our knowI- edge of the agricultural organisms we want to work with and the resources and trained scientists available than by the power of the tools biotechnology provides. Chapter 1 provides a summary of our findings that includes recommendations aimed at improving support for the integration of biotechnology's tools into agriculture. Chapter 2 introduces the significant uses of these tools in research and discusses some applications pertinent to agriculture. Additional scientific details on gene transfer methods applicable to agricultural organisms are provided in the Appendix. The remaining three chapters focus predominantly on policy. Chapter 3 reviews the mandate and organization of institutions that carry out or support agricultural research, how agricultural research is funded, and the present role of biotechnology in agri- cultural research policy. Chapter 4 covers the training of scientists who will utilize the tools of biotechnology in agricultural research. Last, Chapter 5 addresses technology transfer aimed toward bring- ing the benefits of agricultural biotechnology to the marketplace. Here the report reviews the rapidly changing scene of university, industry, and government interactions concerning new research

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PREFACE ~ V11 agreements as well as patent policies. The committee also ad- dresses new roles for agricultural extension and the need for gov- ernment to rapidly address the regulatory problem of field testing genetically engineered organisms. Within the past few years the popular press has captured the public's attention with the role biotechnology will play in agricul- ture, citing both its positive and negative aspects, whether realistic or wildly speculative. As a committee we profess no special insight into what the future will bring, but we do know that the tools of biotechnology will provide the means to better understand the world we live in and thereby increase our knowledge and ability to make wiser decisions. Charles E. Hess Chairman

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Acknowledgments The committee wishes to express its gratitude to the many individ- uals at public and private institutions who generously contributed information crucial to this study. We particularly wish to ac- knowledge those who responded to our invitation to come to one of our meetings in Washington, D.C. and share their knowledge and insights into agricultural biotechnology. They include Win- ston J. Brill, Peter R. de Bruyn, Philip Filner, Gordon G. Hammes, Ralph W. F. Hardy, Virginia H. Holsinger, Theodore L. HulIar, Robert J. Kalter, Edgar L. Kendrick, Gretchen S. Kolsrud, Gwen G. Krivi, Robert Nicholas, Mark L. Pearson, Robert Poling, Leroy Randall, M. Howard Silverstein, Gerald Still, Zachary S. Wochok, and J. Gregory Zeikus. The committee gratefully acknowledges the contributions of its consultants, Chris Elfring, Nancy Hene- son, and William Magrath, in gathering and organizing material for this report, and Phyllis B. Moses for the background paper on gene transfer methods that she prepared during her tenure in 1985 as an NRC fellow. We have included this paper as an appendix to our report. The committee also wishes to thank Aid a Nee! and Susanne Mason, Administrative Secretaries to the study. Finally, the com- mittee appreciates the role of Board on Agriculture staff members James E. Tavares, Project Officer, and Phyllis B. Moses, Staff Officer, in assimilating and expressing our findings in the final report. IX

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Contents . EXECUTIVE SUMMARY AND RECOMMENDATIONS The International Dimension, 1 The Power of Biotechnology, 3 Strategies for National Competitiveness, 4 Recommendations, 7 2. SCIENTIFIC ASPECTS The Power of Biotechnology, 16 Using Gene Transfer to Enhance Agriculture, 17 Isolation of Important Genes, 18 Gene Transfer Technology, 19 Cell Culture and Regeneration Techniques, 20 Monoclonal Antibody Technologies, 21 Summary, 23 New Approaches to Crop Production, 23 The Genetic Engineering of Plants, 24 The Genetic Engineering of Microorganisms Associated with Plants, 27 Genetic Engineering for Crop Protection, 30 New Approaches to Animal Agriculture, 33 Animal Breeding, 33 Microorganisms Associated with Animals, 37 Bioprocessing Opportunities, 41 Alternative Fuels, 41 Alternative Feed and Food Sources, 42 Other Products, 43 Conclusions, 44 Recommendations, 48 X1 1 16

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- X11 3. FUNDING AND INSTITUTIONS Funding Biotechnology in the Agricultural Research System, 51 The Federal-State Agricultural Partnership, 52 Past Contributions from Agricultural Research, 53 Pressures for Change, 54 The Emergence of Biotechnology, 56 Institutions that Support Agricultural Research, 59 Federal Agencies, 59 State Support of Agricultural Research, 68 Private Sector, 70 A Summary of Agricultural Research Funding, 71 Peer Review, 75 Realigning the System for Biotechnology, 76 Funding for Agricultural Biotechnology, 77 Integration of Agricultural Research Disciplines, 81 Recommendations, 86 4. TRAINING Introduction, 90 Personnel Required for Biotechnology, 91 Demand for Scientists, 91 Demographic Trends, 93 Education alla Training, 95 Programs at the U.S. Department of Agriculture, 98 Programs at the National Science Foundation, 100 Programs at the National Institutes of Health, 101 Other Government Programs, 102 Private Support, 103 Conclusions, 103 Interdisciplinary Cooperation, 104 Recommendations, 106 5. TECHNOLO GY TRANSFER Introduction, 108 The Economic Dimension, 108 University, Industry, and Government Interactions, 109 Research Relationships in Technology Transfer, 111 Alliances Related to Agriculture, 115 Implications of Alliances and Research Relationships, 121 Merging Biotechnology into Agriculture, 123 Land-Grant Universities, 123 Cooperative State Extension Service, 125 Regulation and Field Testing, 126 CONTENTS 51 90 108

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CONTENTS Patenting and Licensing, 130 Patents and the Federal Government, 131 Patents and Universities, 135 Revenues from Licenses, 137 Biotechnology Patenting Activity, 138 Nonpatented Intellectual Property, 139 Conclusions, 140 Recommendations, 142 Summary, 143 REFERENCES Appendix: GENE TRANSFER METHODS APPLICABLE TO AGRICULTURAL ORGANISMS Phyllis B. Moses Introduction, 149 Direct DNA Uptake, 154 DNA Microinjection, 157 Cell Fusion, 161 Vector-Mediated Gene Transfer, 163 Prospects, 181 References, 184 INDEX X111 145 149 193

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