With respect to public communication of the health-testing results, the committee found that

The EPA pesticide fact sheets are the most readily available sources of information on human health effects, but they are not transparent with respect to either the tests performed or the results of the tests.

As these documents may be drafted to be accessible to nonexperts, sometimes they give the impression that the studies were not rigorous. For example, the fact sheet on the Bt tolworthi protein expressed in corn (EPA 1998c) describes toxic endpoints in one male and eight female mice in the acute-toxicity test and then states “CLASSIFICATION: Acceptable.” The basis for that classification with some details of the design of the tests, the number of animals involved, and other testing methods should have been presented so that the public could appropriately evaluate the scientific rigor of the test. Another fact sheet, on Bt Cry3A in potato (EPA 1995a), fails to state the number of animals tested; however, details provided by the registrant (Lavrik et al. 1993) make it clear that the tests, although minimal, included an adequate number of animals. Synopses of the methods and data from which the information is obtained would be valuable to the readers. Therefore, the committee recommends that

EPA pesticide fact sheets should be prepared with greater clarity and with more factual information to clearly and quantitatively present the results of safety testing.

EPA addressed the issue of CBI in its proposed rule, and proposes to require substantiation at the time a claim is made (EPA 1994a). In the proposed rule, EPA actively admonished applicants to minimize the amount of data and other information claimed as CBI. Because of inherent differences in their regulatory systems, EPA does not share applications for pesticides with state coregulators as does USDA, so a comparison of treatments of CBI claims is not possible from that perspective. However, EPA does discuss some risk issues related to plant-pesticides with the SAP in public fora (for example, SAP 1994); through that venue, it is possible to assess that the agency has not allowed broad CBI claims. EPA staff report that some registrants' attempts to make broad CBI claims have been rebuffed by the agency (EPA 1999g).

Because EPA's proposed rule is not yet final, the agency has not provided specific guidance to the regulated community on the various aspects of the regulatory approach (Andersen and Milewski 1999). The regulated community under the proposed rule includes academic re-



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