useful in making regulatory decisions about risk. The committee also recommends that APHIS not use general weediness characteristics in its assessments because these characteristics have no predictive value. APHIS must instead use criteria specific to the regulated article and the environments to which it could be exposed. Until recently it was difficult or impossible to determine the full sequence of an inserted gene. Therefore, APHIS’s past acceptance of partial sequence data was reasonable. At this time the agency should require reporting of full DNA sequences of transgenes as they are integrated into the plant genome unless the applicant can provide scientific justification not to do so. Data on flanking sequences also would be useful to determine the exact insertion site of the transgene
APHIS’s environmental assessments of transgenic plants with pesticidal properties include assessment of effects on non-target organisms as well as assessment of the risk posed by the potential of pests to evolve resistance to the pesticidal substance. The treatment of these two issues in APHIS’s Environmental Assessment documents is generally superficial. The committee recommends that for pesticidal plants APHIS should either increase the rigor of assessments of resistance risk and non-target impacts, or it should completely defer to the EPA, which also assesses these risks.
The committee commends APHIS for developing and making available guidelines for applicants who are using any of the three APHIS processes. These guidelines clearly are helpful, especially to small companies and scientists who are generally not familiar with regulatory processes. One way in which these guidelines could be improved would be for APHIS to provide information about what types of evidence it considers necessary for each of the characteristics listed in the guidelines. Without such information it is difficult for applicants to determine the degree of rigor required by the agency in making its assessments. The committee recognizes that APHIS staff are open to personal interaction with applicants, but more detailed published guidance still would be useful. All of these changes would increase the utility of APHIS risk assessments in decision support. The increased rigor provided by these changes also could increase public confidence.
There are a number of aspects of APHIS oversight that bear directly on public confidence. The committee finds that the extent of confidential business information (CBI) in registrant documents sent to APHIS hampers external review and transparency of the decision-making process. Indeed, the committee often found it difficult to gather the information needed to write this report due to inaccessible CBI. It is not clear that APHIS has the power to decrease the unwarranted use of CBI. However,