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GENETICALLY MODIFIED PEST-PROTECTED PLANTS: SCIENCE AND REGULATION
(FQPA) (Public Law 104-170, EPA 1997b) that the agency did not address in the 1994 proposals. FQPA amended FFDCA and FIFRA to include a new safety standard for pesticide residues on food, one notable change being special safety factors for children.
1.5.4 Commercialization of Transgenic Pest-Protected Plants
Under the above USDA, FDA, and EPA statutes, the first transgenic crop varieties were approved for commercial planting in the early 1990s. In 1992, the first transgenic crop variety achieved nonregulated status from USDA. This variety was a tomato line for altered fruit ripening developed by Calgene (Flavr Savr). In addition to USDA review, FDA reviewed the safety and nutritional aspects of the Flavr Savr tomato and a food additive petition from Calgene for the use of the kanamycin resistance trait in tomatoes, cotton, and canola (Kahl 1994). Since this review, FDA conducts its assessments for genetically engineered crops by consulting with companies about the safety and composition of the variety and has not required a food additive petition for any other transgenic product, although it could make such a request in the future. EPA was not involved in reviewing the Flavr Savr tomato because the transgenic modification of the tomato did not involve a pesticidal trait.
In December 1994, the first transgenic pest-protected plant achieved nonregulated status from USDA: a virus-resistant squash variety developed by Upjohn/Asgrow Seed Company that contained watermelon mosaic virus-2 coat protein and zucchini yellow mosaic virus coat protein. The USDA assessments for this crop address such concerns as the likelihood of creating new plant viruses via recombination of the introduced coat-protein gene with naturally occurring viruses, the potential of the two new virus-resistance genes to cause squash to become a weed, and the movement of the genes to wild squash relatives. EPA also reviewed this crop. In the July 27, 1994, Federal Register, EPA published a notice that Asgrow Seed Co. had submitted a pesticide petition to EPA under FFDCA to exempt the coat proteins from the requirement of a tolerance (EPA 1994b). EPA reviewed the petition for safety concerns, such as toxicity, and established an exemption from the requirement of a tolerance under FFDCA for “residues of the plant-pesticides, as expressed in Asgrow line ZW20 of Cucurbita pepo L. and the genetic material necessary for the production of these proteins.” EPA also proposed to exempt viral coat protein genes and gene products from review and registration under FIFRA (Section 1.5.3) (EPA 1994a and 1997b).
Varieties employing the Bt resistance mechanism were the next pest-protected plants to achieve nonregulated status from USDA and to have their gene products reviewed as plant-pesticides by EPA. A Bt potato line