Changes in APHIS Oversight over Time

As emphasized repeatedly throughout this report, the regulation of transgenic organisms is relatively new, and APHIS should be commended for being the first regulatory agency in the world to develop a regulatory framework for the oversight of transgenic organisms. Being first, however, also has its disadvantages because there were no prior regulatory models specific to transgenic crops from which to adapt the system of oversight. Consequently, APHIS-BBEP has had to adapt its procedures at the same time it was creating them—a challenging and sometimes unsettling process.

For example, during 1987, the first year of operation under the newly approved regulatory system, only a handful of permits were received, and each could receive considerable attention from the staff. By 1991, APHIS-BBEP was receiving literally hundreds of permit applications, which greatly stressed the agency’s technical capacity, and the number of petitions was anticipated to increase in the future. Moreover, APHIS-BBEP found that the majority of the applications concentrated on corn, soybean, cotton, potato, tomato, and tobacco. In addition, it was found that confinement procedures required for each of these crops had many similarities. Consequently, in 1992 APHIS-BBEP proposed the development of a notification system so that these common applications, which had already undergone an environmental review under permitting, could receive less oversight. This system was implemented in 1993 and is the cornerstone of the APHIS regulatory process. In 1997 they expanded this notification system, which allows many transgenic plants to be planted without any environmental review. The committee discussed some of the scientific concerns and inconsistencies associated with this expanded process. This notification system provides great regulatory flexibility for APHIS and in principle has considerable scientific validity. The 1993 system, in particular, is an outstanding example of how a regulatory agency can learn from experience and adapt its regulatory procedures.

As discussed in Chapter 2, transgenic crops have been assessed in the United States by APHIS assuming a static non-adaptive risk analysis framework, without systematic regard to the potential for mistakes, in either management or risk assessment. Certainly the system is designed to limit mistakes, but they do occur, and their significance is unknown outside the specific context in which they occurred.

The committee discussed later in Chapter 2 several models that could be used to formally supplement the management framework in APHIS’s risk assessment practices. One such model—the fault tree-analysis—could be used to assess risks that could occur through failure of the current oversight system. Conducting such an analysis would provide APHIS

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