What the framework left unresolved were jurisdictional issues that would have to be addressed before commercial introduction of a number of products, including transgenic plants that were modified to resist disease and ward off insect pests. In fact, plants modified to exhibit pesticidal traits were not specifically addressed by the coordinated framework. Although it contained an extensive discussion of EPA' s authority to regulate pesticides, the framework concentrated almost exclusively on microorganisms that were produced with pesticidal intent (OSTP 1986, p. 23319); this was undoubtedly because research involving transgenic pest-protected plants was at a relatively early stage.
In the 14 years since introduction of the coordinated framework, the lead agencies have worked to coordinate their oversight responsibilities and have resolved many of the issues that were either unforeseen or unaddressed in 1986. Hundreds of new plant varieties have been the subject of federally approved field tests, and dozens of new plant products are on the market today (section 1.5.5). These commercially available transgenic crops include corn, cotton, potato, squash, and papaya that are protected against harmful insects or viruses; and corn, cotton, canola, soybeans, and sugar beet that are modified to tolerate the application of herbicides. Determining which agencies have responsibility for a particular plant-related product depends on two factors: the traits that have been engineered into the plant and the use of the crops that will be harvested. A summary of the key regulatory schemes will help to put this in perspective. In general, the committee found that
Under the coordinated framework, transgenic products are subject to regulation under existing statutory authorities and USDA, FDA, and EPA are exercising regulatory oversight on that basis.
USDA has responsibility for protecting plants and for safeguarding American agriculture. The Federal Plant Pest Act (FPPA) provides USDA with the authority to regulate the movement into or within the United States of organisms that may pose a threat to agriculture and to prevent the introduction, dissemination or establishment of such organisms (US Congress 1957).1 The plant pest definition under FPPA is listed in chapter 1, section 1.4.2 (US Congress 1957, section 150 aa(c)).
The FPPA establishes a permit system that has been expanded by USDA into a comprehensive prerelease review system for potential plant
The FPPA supplements and extends the much older Plant Quarantine Act.