toxicity and potential for allergenicity should be tested. Additional categories of health effects testing (such as for carcinogenicity) should not be required unless justified.

Additional categories of toxicity testing do not appear justified for currently commercialized products such as many Bt proteins (Cry1A and Cry3A) and viral coat proteins. However, it is important that the tests that are performed be rigorous, logical, and scientifically sound. Novel or less familiar plant-pesticides (that is, in comparison to viral coat proteins and Bt toxins) may require additional categories of toxicity testing.

Although the committee realizes that it is often difficult to obtain enough plant-expressed protein for toxicological testing; tests should be conducted whenever possible using the protein as it is expressed in the plant. The committee recommends that

The EPA should provide clear, scientifically justifiable criteria for establishing biochemical and functional equivalency when registrants request permission to test non plant-expressed proteins in lieu of plant-expressed proteins.

In addition to human health toxicity testing, allergenicity testing is very important. The committee recognizes that the FDA has developed preliminary information on the assessment of potential food allergens that could be helpful to applicants as they evaluate potential products and develop product-specific data to address questions concerning allergenicity. The committee recommends that

FDA should put a high priority on finalizing and releasing preliminary guidance on the assessment of potential food allergens, while cautioning that further research is needed in this area.

The committee found some room for improvement in the procedures used in USDA's review of outcrossing or gene flow for virus-resistant squash (section 3.1.4). USDA's commercialization of the squash was controversial because the transgenic squash potentially could transfer its acquired virus-resistance genes via pollination to wild squash (Cucurbita pepo), which is an agricultural weed in some parts of the southern United States. USDA's assumption that transgenic resistance to viruses will not affect the weediness of wild relatives might be correct, but longer-term empirical studies are needed to determine whether this is true. The committee recommends that

USDA should require original data to support agency decision-making concerning transgenic crops when published data are insufficient.



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