Because transgenic crops are new genotypes introduced into the environment, they fall under the legal and regulatory authority of the Federal Plant Quarantine Act (FPQA) and the FPPA. Clearly, this authority could be extended to regulate any aspect of conventional crop variety production. Because there are no general scientific principles for identifying safe transgenic plants and there is a scientific expectation that most transgenic plants will have little environmental effect, the entire category of transgenic crops has been brought in for regulatory review under the FPQA and FPPA. As outlined above, when this is done, there should be a rapid initial evaluation to separate transgenic crops needing additional regulatory review from those that do not. At first, APHIS had no rapid sieve to separate transgenic crops. Consistent with the scientific and logical rationale discussed above, the agency constructed an early rapid sieve empirically, based on the results of its actual risk assessments. Empirical construction avoids the difficulties and pitfalls of ex ante prediction inherent in many of the scientific arguments about the safety of transgenic crops. However, if it is constructed on an overly broad generalization, the sieve can be faulty. The APHIS notification system is the early rapid sieve. While the committee agrees that the general scientific and logical principles underlying this approach are sound, Chapter 5 evaluates the implementation of these principles.

REFERENCE SCENARIOS— THE COMPARATIVE RISK APPROACH

Reference scenarios or reference values are those situations to which the focal risk is compared to contextualize understanding of the risk situation. This will depend on the risk characterization process. For example, if the context is understanding whether the transgenic crop is likely to increase or decrease risks in the area of introduction, the risks of transgenic crops could be compared to the dominant agricultural practice in the area of adoption or to the best agricultural alternative in the area. Thus, Bt cotton is compared typically to conventional cotton grown with high rates of insecticide application, while Bt corn is typically compared to conventional corn without any insecticides applied. In a broader context, transgenic crops could be compared to alternative technologies or technological systems for reaching similar production and environmental goals. For example, the risk characterization might evaluate the policy issue of which technologies or technological systems have lower environmental risks and should be encouraged for future development. Under this context, transgenic crops could be compared with sustainable agriculture and organic production methods.

The context could be considered even more widely in a developing country where a transgenic crop might replace local varieties and cause



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