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Executive Summary
Pages 1-14

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From page 1...
... In 2001, the Food and Drug Administration's Center for Veterinary Medicine (CVM) recognized that it was an opportune time for external scientific discussion to identify the science-based risks and concerns associated with animal biotechnology prior to any regulatory review of the food and environmental safety of these products.
From page 2...
... Goals of the report are to (1) develop a consensus listing of risk issues in the food safety, animal safety, and environmental safety areas for various animal biotechnology product categories.
From page 3...
... Finally, the committee notes that this report is "a snapshot in time"; many of the concerns and risks that are discussed are typical of any new technology, and the initial methodologies that are developed are rapidly replaced with less risky and more sophisticated techniques. It is likely that a similar rate of evolution will occur with the applications of animal biotechnology as evidenced by advances in plant biotechnology.
From page 4...
... The second was whether the food and other products of animal biotechnology, whether genetically engineered, or from clones, are substantially different from those derived by more traditional, extant technologies. A third major concern was whether the technologies result in novel environmental hazards.
From page 5...
... The focus is on concerns related to animal products used in agriculture and medicine. It now is possible to generate animals with useful novel properties for dairy, meat, or fiber production, for environmental control of waste production, and for production of useful products for biomedical purposes or other human consumption.
From page 6...
... In particular, there will (probably) always be concerns regarding the use of unnecessary genes in constructs used for generation of engineered animals, the use of vectors with the potential to be mobilized or to otherwise contribute sequences to other organisms, and the effects of the technology on the welfare of the engineered animals themselves.
From page 7...
... Specifically, the committee considered nongenetically engineered animals that are propagated by nuclear transfer or other cloning techniques, genetically engineered animals developed primarily for meat or animal products such as milk and eggs, and genetically engineered animals developed to produce pharmaceuticals and other medical or non-medical products. The nature of concern for all foods or food products is that they should be free of agents chemical or biologic which affect the safety of the food for the human or animal consumer.
From page 8...
... This makes it difficult to draw conclusions regarding the safety of milk, meat, or other products from individuals that are themselves somatic cell cloned individuals. The key scientific issue is whether and to what degree the genomic reprogramming that occurs when a differentiated nucleus is placed into an enucleated egg and forced to drive development results in gene expression that raises food safety concerns.
From page 9...
... The committee felt that it is difficult to identify concerns without additional supporting data using available analytic tests regarding food product composition. In summary, there is no current evidence that food products derived from adult somatic cell clones or their progeny present a food safety concern.
From page 10...
... Less mobile and highly domesticated animals that do not become feral easily, such as domestic chickens, cattle, and sheep, present the least concern, along with transgenic animals produced for human medical benefits such as xenotransplantation, which have little chance of becoming established in the environment. Colonization by GE animals might result in local displacement of a nonspecific population, which could have a disruptive effect on other species in a community.
From page 11...
... Animal welfare has proven difficult to assess because it is so multifaceted and involves professional and ethical judgments. The committee considered the following facets of animal welfare in discussing transgenic and cloning technologies: their potential to cause pain, distress (both physical and psychologic)
From page 12...
... Although there generally are fewer potential animal welfare concerns associated with the production of transgenic farm animals for biomedical purposes than for agricultural purposes, some concerns remain. A common method to produce pharmaceuticals in animal tissues or fluids is to produce transgenic cattle or goats that express the protein of interest in mammary tissue.
From page 13...
... For example, religious or cultural groups might have dietary norms or rules that might be violated by genetic engineering of animals used for food. Regulatory decisions and enforcement are difficult in the absence of an ethical framework underlying regulatory decisions related to animal biotechnologies or a regulatory framework for addressing unique problems and characteristics associated with animal biotechnologies.
From page 14...
... In addition to the potential lack of clarity about regulatory responsibilities and data collection requirements, the committee also notes a concern about the legal and technical capacity of the agencies to address potential hazards, particularly in the environmental area. The committee considers it appropriate to identify some of the potential social implications of animal biotechnology.


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