present, but as more pharmaceutical-producing plants are developed, it may be used more frequently.
The dominant path toward commercialization—petitioning for nonregulated status—is in essence a request for APHIS to determine that there is no plant pest risk (or as commonly understood, no environmental risk) associated with the specific transgenic plant. If APHIS makes this determination, it agrees that the plant no longer needs regulation. As currently implemented, APHIS deregulation is absolute. Once deregulated, the agency does not assume further oversight of the plant or its progeny and descendants. As part of the petitioning process APHIS always conducts a formal Environmental Assessment and publishes this assessment in the Federal Register, providing the public with a 60-day comment period. APHIS personnel are required to respond to each comment received.
The committee examined six individual petitions for nonregulated status conducted over a period of four years. Based on these detailed assessments as well as an examination of the general process of APHIS oversight, the committee finds a number of places where APHIS could improve its technical risk assessments and the manner in which it involves the public in policy development and decision making. In general, the committee finds that the APHIS process should be made significantly more transparent and rigorous by enhanced scientific peer review, solicitation of public input, and development of determination documents with more explicit presentation of data, methods, analyses, and interpretations. Such changes are likely to improve the agency’s risk analyses at both the level of decision support and the level of maintenance of regulatory authority.
To improve the rigor of decision support, the committee recommends that, whenever changes in regulatory policy are being considered, APHIS should convene a scientific advisory group. This is a common practice of the EPA. Before APHIS first introduced the notification procedure, it formally requested input from the then-active USDA Agricultural Biotechnology Research Advisory Committee (ABRAC). Such formal input has not been sought since that time. The committee recommends that before making specific, precedent-setting decisions, APHIS should solicit broad external scientific review well beyond the use of Federal Register notices.
Specific attributes of APHIS’s environmental assessments require comment. The committee recommends that APHIS should not use the term “no evidence” in its environmental assessments. The term “no evidence” can mean either that no one has looked for evidence or that the examination provides contrary evidence. Lack of evidence is not typically