each crop as well as by agronomic practices and land uses specific to each particular crop that is commercialized. Throughout this report, discussion of risk characterization and risk management has focused on procedures that can and should be used to measure the likelihood and extent of such damage and to mitigate environmental risks. It is appropriate that regulators focus intently on such specifics when evaluating any particular transgenic crop. In looking toward the future, however, it is also important to ensure that the details of risk analysis do not obscure the larger context in which discussions about agriculture and the environment are situated. In this section, the discussion is focused on three related regulatory concerns from this larger perspective. The committee considers how the future of commercialized transgenic crops may challenge both U.S. and global capacity for environmental risk analysis and the ambiguities surrounding the precautionary principle and the development of its use worldwide. Then, the committee turns to the changing domestic standards for environmental regulation and some implications for regulation of any agricultural practice.

U.S. and Global Capacity for Environmental Regulation

The overall adequacy of the U.S. Coordinated Framework for the Regulation of Biotechnology has been a frequent subject of discussion throughout the brief history of transgenic crops. Krimsky (2000) finds the coordinated framework to have failed to adequately manage environmental risk, while Malinowski (2000) finds it to have been remarkably successful. It is beyond the scope of this report to evaluate the entire framework, and so instead several points are provided for consideration that may challenge the regulatory system in the near future.

As noted above, some of the coming applications of biotechnology may involve the use of plants to produce pharmaceutical products, biologics, fuels, and other substances not intended for human food use. The introduction of such transgenes poses the potential for environmentally associated risks of a wholly different order than those associated with existing transgenic crops. If such a transgene moves into food crops, either through pollen transfer or physical contamination, there could be serious human safety risks. If such a transgene moves into a wild relative, there could be widespread environmental dissemination of the pharmaceutical substance or other nonfood substances that could have impacts on wildlife as well as microbial populations.

Provisions for regulation of such environmental risks are identified under the existing coordinated framework. Environmental risks associated with pharmaceutical-producing plants, for example, could be regulated by the Food and Drug Administration under the authority it cur-



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