The controversial changes proposed in 1995 that went into effect in 1997 were created by APHIS internally, and the scientific response of APHIS also was internal. This subcommittee recognizes that the proposed changes of 1995 were precedent setting (e.g., extending the notification procedure from six crops to all nonweed plants) and created without external scientific input beyond those respondents to the Federal Register notice. It is certainly possible that APHIS may continue to propose and make important policy changes without external scientific input.

Recommendation 3.1: For changes in regulatory policy, APHIS should convene an external scientific advisory group and hold at least one meeting to solicit public scientific input to review proposed changes.

SCOPE AND REGULATORY PROCEDURES USED BY APHIS

APHIS currently regulates transgenic plants under 7 CFR part 340, “Genetically Engineered Organisms and Products: Simplification of Requirements and Procedures for Genetically Engineered Organisms,” which was published in 1997.

Anyone introducing (importing, transporting interstate, or releasing into the environment) a regulated article must have authorization through either a notification or a permit and must comply with other restrictions as described in 7 CFR part 340. The regulations provide APHIS with the authority to regulate such introductions for certain transgenic organisms. The regulatory objective of 7 CFR 340 is to allow the evaluation of transgenic organisms with sufficient scrutiny to identify any plant pest risks at an early enough stage to allow remedial action prior to the occurrence of any real damage.

The basis for regulation is the broadly defined plant pest. Part 340.1 provides definitions for the terms used (see BOX 3.1). Plant pest is defined as “any living stage (including active and dormant forms) of insects, mites, nematodes, slugs, snails, protozoa, or other invertebrate animals, bacteria, fungi, other parasitic plants or reproductive parts thereof; viruses, or any organisms similar to or allied with any of the foregoing; or any infectious agents or substances, which can directly or indirectly injure or cause damage in or to any plants or parts thereof, or any processed, manufactured or other products of plants.” Under this definition, almost all organisms (and their derivatives) can be potential plant pests, including, for example, herbivorous invertebrate animals (anything that eats a plant can be considered a plant pest). A transgenic organism is considered a regulated article if it is a plant pest or if it or a gene donor or vector used in its construction are plant pests according to a long list of taxa listed in 7 CFR



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