ing legislation: for example, plants came under the jurisdiction of the Federal Plant Pest Act (FPPA) administered by the USDA; food and feed under the jurisdiction of the Federal Food, Drug, and Cosmetic Act (FFDCA) administered by the FDA; and microorganisms and substances used for pest control under the jurisdiction of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and parts of FFDCA, administered by the EPA. Transgenic pest-protected plants were not addressed in the original framework document.

USDA published its policy under the coordinated framework providing for field testing permits for transgenic plants in 1987 and field testing notifications in 1993 and 1995. In 1993, it finalized its policy for determining when certain plants would no longer be regulated articles. In 1992, FDA published its policy for foods derived from new plant varieties based on its role under FFDCA. In 1994, EPA proposed a rule to regulate the pesticidal substances in pest-protected plants as plant-pesticides under FIFRA and FFDCA. Several groups opposed that statutory interpretation on both legal and scientific grounds; others supported the EPA's oversight of transgenic pest-protected plants, given the agency's mission to address environmental concerns. In the last few years, there have been concerns expressed by several professional societies and other groups over the broad scope of the proposed EPA rule and opposite concerns expressed by consumer and environmental groups that the EPA rule does not adequately cover all of the risk issues.

ES.6.2 Overall Approach

The committee recognizes that

There is an urgency to complete the regulatory framework for transgenic pest-protected plant products because of the potential diversity of novel traits that could be introduced by transgenic methods and because of the rapid rate of adoption of and public controversy regarding transgenic crops.

Accordingly, the committee has chosen to take EPA's proposed rule and the overarching coordinated framework as given and as designed for transgenic products11, and to examine ways in which this current regulatory approach and its use of scientific information might be improved. In so doing, the committee does not suggest that this is the only possible approach to regulating these products. It is beyond this committee's


Although the committee focuses on the regulation of transgenic pest-protected plants, conventional pest-protected plants are discussed for scientific comparisons.

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