be regulated; and genetically engineered organisms are not fundamentally different from nonmodified organisms. A 1987 National Academy of Sciences white paper came to similar conclusions, recommending regulation of the product, not the process, and stating that genetically engineered organisms posed no new kinds of risks, that the risks were “the same in kind” as those presented by nongenetically engineered organisms (NAS 1987) (section 2.2.1).

The coordinated framework considered existing regulations and laws that were potentially applicable to biotechnology and proposed how EPA, USDA, and the Food and Drug Administration (FDA) would cooperate to review the safety of biotechnology products. USDA was designated the lead agency for regulating genetically engineered crops. FDA was designated to review transgenic crop varieties used for food under the Federal Food, Drug, and Cosmetic Act (FFDCA; US Congress 1958). EPA later clarified its interpretation of the statutes to include “plant pesticides” for regulation under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA; US Congress 1947) and FFDCA (EPA 1994a, c). NEPA is applicable to all federal agencies. The current regulation of biotechnology products is shown in table 1.2. Not all the products in table 1.2, namely plant-pesticides, were discussed in the original coordinated framework.

Shortly after the coordinated framework was developed, USDA reviewed and approved transgenic crop varieties for field trials under the Federal Plant Pest Act (FPPA;US Congress 1957).5 According to the act, a plant pest is:

any living stage of … insects, mites, nematodes, slugs, snails, protozoa, or other invertebrate animals, bacteria, fungi, other parasitic plants or reproductive parts thereof, viruses, or any organisms similar to or allied with any of the foregoing, or any infectious substances, which can directly or indirectly injure or cause disease or damage in any plants or parts thereof, or any processed, manufactured, or other products of plants.

Using the coordinated framework as a guide, USDA was the first agency to propose a regulation for the review of plants genetically modified with rDNA methods. On June 16, 1987, a Federal Register notice established procedures for obtaining permits for releasing genetically engineered organisms into the environment in field trials (USDA 1987). Under that regulation, coverage extends to organisms or substances that meet the definition of a plant pest or that USDA chooses to designate as a plant pest.

5  

The FPPA supplements and extends the much older Plant Quarantine Act.



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