. "4. Strengths and Weaknesses of the Current Regulatory Framework." Genetically Modified Pest-Protected Plants: Science and Regulation. Washington, DC: The National Academies Press, 2000.
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GENETICALLY MODIFIED PEST-PROTECTED PLANTS: SCIENCE AND REGULATION
sheets, press releases, and their own websites and databases to provide such explanations.
Having been commercialized only within the last 5 years, transgenic pest-protected plant products have a relatively new regulatory framework. As more and more-diverse products approach the market, new issues and issues that might be less important for conventional products might warrant attention. For example, the development of Bt transgenic plant products has brought to light issues concerning insect resistance management (section 2.9). One specific concern is the potential effect of these products on the utility of Bt foliar spray products if widespread resistance to Bt insect control proteins evolves in pest populations. Resistance management is not a new issue and is not unique to Bt crops, but it has been left largely to industry and USDA to address through research, development of best practices, educational programs for growers, and other nonregulatory mechanisms. However, EPA has taken a regulatory approach to Bt crops. It has required research and monitoring, limited geographic use of some products, imposed agricultural practices for some products, and required the development and implementation of resistance management plans that rely on high Bt dose and the establishment of refugia to minimize the onset of resistant pest populations. This new role for EPA constitutes a broad set of regulatory initiatives that will probably require substantial resources to maintain, and represents a departure from, for example, the EPA initiative under the North American Free Trade Agreement that proposes voluntary labeling for resistance management related to conventional pesticides (EPA 1999e).
In contrast with EPA's approach, USDA appears to have determined that resistance management, at least as related to Bt crops, is not a plant pest risk issue that would be appropriately addressed through regulation under FPPA. But some USDA offices are working cooperatively with EPA to establish pest management centers that would foster research, education, and nonregulatory approaches to resistance management. These pest management centers are in their infancy, and it is unclear how successful they will be. One example of an activity proposed for these centers is to develop insect resistance management strategies to pesticides expressed in transgenic pest-protected plants.
In summary, the committee found that
As more transgenic pest-protected plant products reach the marketadditional issues concerning their safety and effective deploymentwill probably come to light. Not all of them will rise to a levelthat warrants regulation, nor will they all be amenable to traditionalregulatory solutions.
Bt crops raise an important question with regard to resistance man-