and commercialization were examined in detail (case studies). During these two phases the committee communicated with APHIS personnel to avoid missing any crucial unpublished information and to learn more about the day-to-day operations of the APHIS-BBEP. Finally, the information gathered was used to determine how well APHIS oversight is meeting the two general roles of risk assessment, and to develop recommendations for specific changes in that oversight.

The committee finds that APHIS and other regulatory agencies charged with assessing the safety of transgenic plants face a daunting task. This is so in part because environmental risk assessment of transgenic plants is new and in part because the social context in which regulatory decisions about transgenic organisms must now be made is dramatically different from the one in which these agencies have been accustomed to work. The committee finds that the APHIS regulatory system has improved substantially since it was initiated. For example, in two Bt corn petitions for nonregulated status, one completed in 1994 and one in 1997, the breadth of environmental issues addressed and the degree of rigor with which they were addressed improved with time. Furthermore, the development of a notification process that utilizes ecologically-based performance standards was an important step in effectively streamlining the field-testing process. The learning process at APHIS has not come without missteps, but the agency seems to use them as opportunities for further improvement. In its role of analyzing APHIS environmental reviews the committee mostly searched for problem areas as a means to help improve a functioning system.

APHIS has been criticized for regulating transgenic crops with statutes that do not cover all transgenic plants. The committee finds that APHIS currently has the authority to base regulatory scrutiny on potential plant pest status, regardless of the process of derivation, and therefore can theoretically regulate any transgenic plant. However, the only practical trigger used by APHIS is the presence of a previously identified plant pest or genes from a plant pest in the transformed plant. Other operational triggers are needed for transgenic plants that may have associated risks but lack the above characteristics.

APHIS jurisdiction and the focus of its Environmental Assessments are confined to the United States, but some APHIS assessments discuss potential environmental effects of specific transgenic plants outside the United States. There is a need to clarify this discrepancy. If APHIS jurisdiction is to remain confined to the United States, Environmental Assessments should clearly state that they do not consider risks beyond United States borders.

APHIS documents reviewed by the committee also are inconsistent regarding APHIS authority to deregulate transgenic plants on a limited

The National Academies | 500 Fifth St. N.W. | Washington, D.C. 20001
Copyright © National Academy of Sciences. All rights reserved.
Terms of Use and Privacy Statement