USDA should clarify the scope of its coverage as there are some transgenic pest-protected plants that do not automatically meet its current definition of a plant pest

4.3.4 Clear Establishment of Lead and Supporting Agencies With a Mechanism for Effective Interagency Communication

The coordinated framework does not identify lead and supporting agencies for oversight of transgenic pest-protected plants. That is probably because research with this category of plants was relatively new when the framework was created and field testing had not yet been conducted. Instead, the coordinated framework indicates that USDA is the designated lead agency for plants and reiterates that EPA has exempted from registration, under FIFRA, plants that are biological control agents.

Although EPA's 1994 proposed policy (EPA 1994a) reiterates the exemption of plants as biological control agents, it points out that EPA will regulate pesticidal substances expressed in the plants and the genetic material necessary for the production of the substances. The policy also clearly articulates the division of jurisdiction over the substances between EPA and FDA. The policy states that EPA will address food safety issues associated with pesticidal substances, including selectable markers; FDA will be responsible for any food safety issues separate from pesticidal substances such as changes in food quality and unintended compositional changes. That clear delineation of responsibility has resulted in product reviews that avoided duplication and achieved consistency. The committee found that

The delineation of EPA and FDA jurisdiction over transgenic pest-protected plant products is generally well defined. Agency reviews generally lack duplication and achieve consistency. The agencies are working together in an effort to potentially modify jurisdiction over selectable markers in the future to reduce ambiguity and minimize the potential for duplication.

Since publication of the 1994 policy, EPA and FDA have identified selectable markers as an area where a shift in lead agency may be appropriate. Having reviewed numerous products that contain selectable markers and having received public comments on this issue, EPA published a request for comments on excluding selectable markers as pesticide inert ingredients. EPA proposed that FDA rather than EPA, have direct jurisdiction over those substances in food products. Among the reasons given for the proposed change were statutory ambiguity pertaining to EPA oversight of selectable markers and public comments asserting the poten-



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