withdrawn or otherwise voided. As noted in chapter 1, about 40% of permits and notifications involve transgenic pest-protected plants.

Another important exemption allows researchers to petition USDA for a determination that an article should not be regulated as a plant pest. The rules contain detailed requirements for the data and information to be included in a petition for determination of “nonregulated status ”. USDA will publish a notice in the Federal Register and provide for a 60-day public-comment period for each petition that meets the rules' eligibility criteria. USDA has approved 50 of 69 petitions submitted for nonregulated status; the other 19 were withdrawn or found to be incomplete or void.

Before issuing a permit for the release of a regulated article into the environment, USDA must follow the requirements of the National Environmental Policy Act (NEPA; US Congress 1969) by preparing a publicly available environmental assessment and if necessary, an environmental impact statement (USDA 1995b). Before acknowledging the appropriateness of a notification or issuing a permit for an environmental release, USDA must coordinate with the state where the release is planned, submitting a copy of the application or notification to the state department of agriculture for review (USDA 1987, sections 3e and 4b).

4.1.2 The Food and Drug Administration and the Regulation of Food

The Federal Food, Drug and Cosmetic Act (FFDCA) provides FDA with broad regulatory authority over foods and food ingredients (US Congress 1958). No particular statutory provision or regulation deals expressly with food produced by biotechnology. FDA's formal position concerning such foods, as expressed in the coordinated framework, is that the statute provides ample tools for the agency to apply to meet the challenges of novel foods and biotechnology (OSTP 1986, p. 23309). That position was confirmed in 1992 on publication of a comprehensive policy statement for foods derived from new plant varieties (FDA 1992).3

The 1992 policy provides that foods developed through genetic modification are not inherently dangerous and, except in rare cases, should not require extraordinary premarket testing and regulation. The policy holds that genetically modified foods should be regulated as ordinary foods are unless they contain substances or demonstrate attributes that are not usual for the product. According to FDA, most food-related issues concerning


The FDA's current policy on the labeling of foods derived from new plant varieties is discussed in the 1992 notice, 57 Fed. Reg. at 22991, and in a separate notice published in 1993, 58 Fed. Reg. 25837.

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