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GENETICALLY MODIFIED PEST-PROTECTED PLANTS: SCIENCE AND REGULATION
attention on pesticidal substances produced in plants rather than the plants themselves. These substances and the genetic material leading to their production are referred to in the 1994 proposed rule as plant-pesticides. USDA has declared some genetically engineered plants to be “regulated articles” because of potential plant pest risk. FDA regulates foods derived from new plant varieties. The lack of consistent product definitions appears to be an unavoidable outcome of regulating under existing statutes. Agencies can minimize the confusion that results from this situation by aggressively communicating how their regulations link to cover the full range of potential concerns (for example, food safety, environmental protection, and plant pest risk) for a single transgenic pest-protected plant product such as corn modified to express the Bacillus thuringiensis insect-control protein.
There is a more urgent need concerning consistency in the scope of transgenic pest-protected products regulated by EPA, USDA, and FDA. The scope of products covered needs to be consistent across agencies to the greatest extent possible to ensure that all products receive the appropriate oversight, and that human health and the environment are thus protected appropriately. EPA articulates a broad scope of coverage that appears to include all plant-expressed substances that meet the FIFRA definition of “pesticide,” including some plantregulators (EPA 1994a). Several categories of plant-expressed pesticidal substances are then proposed to be exempt from regulation because the agency believes that they are of a type that does not require regulation under FIFRA or that they are adequately regulated by other federal agencies (section 1.5.3 and section 3.2).
FDA's regulatory coverage is similarly broad. It covers all food and feed, irrespective of how they were developed. There are no explicit exemptions from coverage, but premarket approval is not required unless a food or feed contains substances or demonstrates attributes that are not usual for the product. USDA exercises explicit regulatory authority over transgenic pest-protected plants that have been genetically engineered to contain inserted genetic material believed to have plant pest potential. All other transgenic pest-protected plants are implicitly exempt from USDA regulation unless the agency has a “reason to believe” that they could pose a plant pest risk.
Thus, all three agencies appear to have broad regulatory authority to cover transgenic pest-protected plants, but USDA and EPA have elected to narrow their effective scope of coverage by exempting particular products. The committee identified situations in which such exemptions warrant further scrutiny: the current limitation of USDA's explicit scope of oversight and EPA's proposed broad exemption of virus coat proteins under FIFRA (section 3.2.2). Both situations have the potential to result in gaps in regulatory coverage that could lead to instances where public