cially planted. The regulation was finalized in 1993 (USDA 1993). For a crop to achieve nonregulated status, “environmental assessment ” and “determination of nonregulated status” documents are prepared by USDA; the documents address safety concerns under the FPPA such as impacts on agriculturally beneficial organisms, as well as addressing the agency's NEPA requirements (section 4.1.1).

1.5.2 FDA Policy

Also in 1992, FDA published a policy statement on its role under FFDCA for reviewing new plant varieties developed by all methods, whether transgenic or conventional (FDA 1992) (section 4.1.2). The FFDCA authorizes FDA to control foods that are “adulterated” with added substances, including naturally occurring substances. The 1992 policy established FDA's role in reviewing the overall composition of the nutrients and toxicants in genetically modified plants. The policy states that “key factors in reviewing safety concerns should be the characteristics of the food product, rather than the fact that the new methods are used.”

Under the 1992 policy, FDA asks that companies develop information to determine whether or not the company is obligated to come to the agency for formal regulatory review. Considerations include genetic stability, compositional and nutritional quality attributes of the plant, and toxicity and allergenicity of the gene product. FDA requires that companies submit nutritional and safety data to the agency if there is reason to believe that new plant varieties may pose risks. After publishing its 1992 policy, FDA recommended that companies developing transgenic varieties consult with the agency before marketing a new variety. Guidelines for this voluntary consultation process were published by the FDA in October 1997 (FDA 1997c). Over 45 transgenic plants, including numerous transgenic pest-protected plants and all crop plants that have been marketed in the United States, have gone through the consultation process. FDA has not required that any of the proteins added to transgenic plants be reviewed as food additives 6.

1.5.3 EPA Policy

In the early 1990s, EPA held numerous public meetings of the Biotechnology Science Advisory Committee (BSAC) to develop its regulations for products of biotechnology. In 1994, EPA published proposed


However, the antibiotic resistance genes in the Flavr Savr tomato were reviewed as food additives at the request of the tomato's manufacturer (section 1.5.4).

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