acceptable. These are questions yet to be addressed and resolved in the context of transgenic animals.

Another policy-related concern is the regulatory environment with respect to animal welfare. The animal welfare regulatory system in the United States is complex. Livestock used for biomedical research are covered under the Animal Welfare Act Regulations (AWRs) and the Public Health Service (PHS) Policy, which also covers research projects funded by national research institutes like the National Institutes of Health. Fish and birds used in biomedical research funded by national research institutes also are covered under the PHS policy, but are not regulated by the U.S. Department of Agriculture (although the USDA has announced its intention to regulate birds). Both the PHS policy and the AWRs require that animal research protocols be reviewed and approved by an Institutional Animal Care and Use Committee prior to their initiation. The intent of such review is to ensure that animal pain and distress are minimized, that alternatives have been investigated, and that the minimum number of animals necessary to achieve research goals is used. There is no such requirement for review of production-related (i.e., food and fiber) research protocols involving animals, although voluntary standards for such review are available (in the so-called Ag Guide; FASS, 1999). This two-tier system means that research projects involving biomedical uses of genetically manipulated farm animals for xenotransplantation and pharmaceutical production will be reviewed for their potential impacts on animal welfare, and the animals involved in those projects will be subject to some type of oversight. Those projects directed toward genetic manipulation for improved food or fiber production, on the other hand, might or might not be subject to such review and oversight, depending upon whether or not the institution at which the research is conducted has chosen to adopt the Ag Guide or a similar set of standards.

An additional concern relates to the effect of the patent process on animal welfare. If technologies to reduce the number of animals used in transgenesis, or to reduce the incidence of developmental abnormalities, become available but are patented, those technologies might not readily be accessible to producers and marketers of genetically engineered animals. Less sophisticated technologies that have more negative impacts on animal welfare might thus continue to be used for the production of transgenic animals.


The institutional framework for regulation of animal biotechnology affects how science-based concerns about the technology will be identified and resolved. The committee has identified features of the institutional framework that raise concerns, including the multiplicity of agencies and statutes potentially involved in regulatory oversight of animal biotechnology and the legal and

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