scope to determine which of the three federal agencies (USDA, EPA, or FDA) is best suited to regulate pesticidal substances expressed in transgenic plants.

EPA's current proposal for regulating pesticidal substances in pest-protected plants claims broad jurisdiction over such products in all seeds and plants sold with claims of pest-protection, but it grants a generic exemption from registration to those bred by conventional means. The committee agrees with EPA's proposed exemption of pesticidal substances in conventionally bred plants, because the committee recognizes that there are practical reasons for exempting those substances based in part on historical experience of safe use of, and the benefits provided by these crops. However, the committee questions the scientific basis used by EPA for this exemption because there appears to be no strict dichotomy between the risks to health and the environment that might be posed by conventional and transgenic pest-protected plants.

The committee found that, in some cases, the use of conventional pest-protected crops might have the potential to lead to human and animal health impacts; therefore

There is a need to significantly increase research aimed at assessing the potential risks posed by conventional pest-protected plants, and make improvements of conventional breeding procedures, if found appropriate.

ES.6.3 Scientific Basis for the 1994 Proposed EPA Rule

Consistent with the coordinated framework and its statutory mandates, EPA has asserted jurisdiction over pesticidal substances in transgenic pest-protected plants in its 1994 proposed rule. The committee reviewed the scientific basis of EPA's 1994 proposed rule and the exemption of certain categories of transgenic pest-protected plants under this rule. The committee found most of the criteria used by EPA for assessing transgenic pest-protected products to be scientifically valid, but there were some exceptions.

EPA proposes to exempt all plant-pesticides where the structural gene for producing the plant-pesticide is derived from a sexually compatible plant. The committee found that the current EPA rule would exempt transgenic pest-protectants if the structural gene came from a sexually compatible plant, regardless of the source of the promoter for expression of the gene. This categorical exemption of transgenic pest-protectants derived from transgenes from sexually compatible plants could result in no EPA regulation of genetically engineered products which contain higher levels of toxicants. The committee agrees that, in many cases,



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