APHIS would not examine the conventionally bred, stress-tolerant canola because of the process used to breed it. Therefore, it might appear that the APHIS trigger is not justifiable.

Before discussing the scientific details of the issue related to transgenic crops, the committee addresses two related issues. First the Office of Science and Technology Policy (OSTP) scope statement (1992) concerning the regulatory trigger is reviewed. The guidance is found to be ambiguous. Second, another regulatory trigger used by APHIS under the same statutory authority that it regulates transgenic crop plants is reviewed. The committee finds that APHIS has adopted a different process-based trigger to meet these other regulatory responsibilities.

OSTP Scope

The entire coordinated framework (OSTP 1986) is premised on regulating transgenic organisms (i.e., using the process of transformation to trigger the entire regulatory apparatus it describes). Hence, from its very inception, use of a process-based trigger to regulate transgenic organisms has existed. The coordinated framework did not fully address how oversight should be exercised by federal agencies under the various statutes, so in 1992 OSTP issued a statement on the scope of oversight so that common principles would govern decisions on how to regulate transgenic organisms.

The Final Statement of Scope (Section III) states that:

federal agencies shall exercise oversight of planned introductions of biotechnology products into the environment only upon evidence that the risk posed by the introduction is unreasonable. A risk is unreasonable [when] the full value of the reduction in risk obtained by oversight exceeds the full cost of the oversight measure. (6,756)

Any regulatory trigger that adheres to this principle is consistent with the OSTP scope statement. This statement is silent on the use of the transformation process as a trigger for regulatory oversight. While the final statement supersedes all previous discussion on scope, it is nevertheless instructive to examine some of the principles in the 1992 document that the final statement supercedes.

In Section II.A (6,756), three fundamental scope principles are articulated:

  1. A determination to exercise oversight within the scope of discretion afforded by statute should not turn on the fact that an organism has been modified by a particular process or technique, because such fact is not alone a sufficient indication of risk.

  2. A determination to exercise oversight in the scope of discretion afforded by statute should be based on evidence that the risk presented by



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