questions and issues surrounding animal biotechnology and its products that engaged the committee and resulted in this report.

Criteria for Selecting Concerns

The primary criterion for selection of concerns that emerged from committee discussions in each of these areas is based on the judgment of the immediacy and potential severity of the risk based on scientific information. The committee also categorized risks by examining a) differences between products of conventional breeding and those produced by biotechnology that might affect food safety; b) adverse effects of biotechnology on the environment in comparison to conventional techniques; c) adverse effects of biotechnology on the health and welfare of animals in comparison to conventional techniques; d) unintended genetic effects resulting from biotechnology techniques; and e) the existence of regulatory authority and the technology platform for detection and regulation of potentially hazardous biotechnology procedures.

As in any analysis of risks resulting from new technologies, it almost is impossible to state that there is “no concern” associated with an aspect of that technology. The issues identified in this report were listed as science-based concerns because the committee identified one or more outcomes that reasonably can be expected to carry some risk—even if small. Some concerns were discussed for which the committee could find no scientific basis. These were identified in the text. While the sponsor of this study is a U.S. regulatory agency, all of the concerns discussed in this report are not restricted to the U.S. and are relevant wherever this technology might be considered or applied. 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. Nonetheless, the committee often was challenged by the paucity of data that might have provided stronger insights of the relative risks for the techniques and applications that were discussed; the committee notes this point where relevant throughout the report.


Rapid advances in biology made since the structure of DNA was clarified provide techniques that have enhanced food production and improved human health. Advances are expected to continue and are likely to have an even greater impact in the future. However, the benefits of advanced technology rarely come

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