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GENETICALLY MODIFIED PEST-PROTECTED PLANTS: SCIENCE AND REGULATION
status and provide comment to USDA. In response to states' concerns that applicants were designating most submitted information CBI, the agency has provided clarification on kinds of submissions that may not be so designated (USDA 1999c).
Transparency at the Environmental Protection Agency
Before EPA's Office of Pesticide Programs (OPP) issued its proposed rule in November 1994 (EPA 1994a), the agency discussed its regulatory direction with the Scientific Advisory Panel (SAP), an external scientific advisory body for OPP on matters related to FIFRA and pesticide tolerance issues under FFDCA (SAP 1994). The proposal included a policy statement that generally laid out the basis for the rule and aspects of EPA 's regulatory approach to this wholly new kind of pesticide regulation. The agency began providing regulatory coverage to some plant-pesticides before the publication of the proposed rule (EPA 1994a, b). The availability of information on the regulatory program is discussed below from the standpoint of the interested public and the affected regulatory community.
Beyond the traditional means of communicating its regulatory decisions on new plant-pesticides through the Federal Register, EPA has used its website to improve the transparency of its regulatory program. The website provides access to pesticide fact sheets, which summarize the kinds of data and risk issues evaluated by the agency for individual active ingredients in making regulatory determinations, and it links to Federal Register notices of regulatory determinations under FIFRA and FFDCA (EPA 1999b). More-detailed evaluations of submitted data are not available on the website but can be requested under the Freedom of Information Act. EPA is not always able to respond to such requests in a timely manner, however, and the committee recommends that
EPA make data evaluations readily available on its website or inresponse to written requests.
The website provides text of presentations by EPA officials, which contain details of current regulatory approaches to plant-pesticides. (EPA 1999b). This latter resource, along with EPA fact sheets, is currently the best source of information on the kinds of data that the agency is asking for to address the array of substantive risk issues posed by plant-pesticides. EPA has also posted information and papers regarding issues on resistance management related to Bt crops (EPA 1998d and 1999b); this information is an extension of discussions between EPA and the SAP.