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Animal Biotechnology 美国科学出版社出版的书，英语的， ISBN: 0-309-50218-7, 201 pages, 6x9, (2002) Committee on Defining Science-Based Concerns Associated with Products of Animal Biotechnology, Committee on Agricultural Biotechnology, Health, and the Environment, National Research Council ISBN: 0-309-50218-7, 201 pages, 6x9, (2002) 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 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 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 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