highlighted in the coordinated framework (OSTP 1986), and the committee has considered each of them in its evaluation of the current status of interagency coordination in regulating transgenic pest-protected plant products. Although all the elements are desirable for promoting coordination, the committee recognizes that they might not all be relevant for every product. The committee also understands that the degree to which some of the elements are achievable is limited by the requirements of the statutes that the agencies administer. The following sections of this chapter discuss those elements outlined in box 4.1.

4.3.3 Consistency of Definitions and Regulatory Scope

To facilitate consistent and efficient regulation, the coordinated framework established the principle that agencies should adopt consistent definitions of regulated products “to the extent permitted by their respective statutory authorities.” An important implication of this principle is that definitions affect the scope of products subject to regulation. Each agency must be cognizant of the scope of products delineated for regulation by its fellow agencies to ensure that regulatory coverage is coordinated and complete, but not unnecessarily duplicative. The committee found that

Although statutory constraints prevent agencies from adopting uniform definitions for certain regulatory terms, this does not appear to have unduly hindered their ability to implement meaningful regulations.

Each agency defines transgenic pest-protected plant products in terms consistent with its regulatory authority: pesticides for EPA, plant pests for USDA, and foods for FDA (table 4.2). The result is that there is no uniform interagency definition of these products. EPA focuses regulatory

TABLE 4.2 EPA, USDA, and FDA Definitions of Regulated Products and Substances





Regulated Product

Plant-pesticide (plant-expressed protectant)

Plant pest, regulated article

Food, feed, food additive

Regulated Substance

Pesticidal substance and genetic material necessary for its production

Organism engineered to contain sequences from plant pests

Human food (whole or processed), animal feed

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