searchers, plant breeders, and seed companies and is substantially more diverse than registrants of traditional pesticides. The agency has endeavored to communicate with the broader group through presentations at national meetings and has tried to work closely with groups or individuals seeking clarification of proposed exemptions and guidance on making an application (Milewski 1997; Andersen and Milewski 1999). Registrants of traditional pesticides that have expanded their scope of business to include transgenic pest-protected plant products are better prepared to respond to the new regulatory coverage because of their familiarity with the existing system. More specificity on the regulatory process is available through individual staff identified on the website. The division managing the registration of plant-pesticides would benefit from having an ombudsperson to advise potential registrants, modeled after similar positions in other OPP divisions that register chemical pesticides.
The absence of clear guidance beyond the proposed rule itself on the following three subjects detracts from the transparency of EPA 's regulatory programs: how to determine more definitively whether a plant-pesticide qualifies for the proposed exemptions, how to seek exemptions under FIFRA or FFDCA, and what specific kinds of data or rationale are needed by the agency to execute its regulatory program. This lack of transparency affects not only potential registrants or others affected by the proposed rule, but also affects state pesticide co-regulators and the public in understanding how the regulatory coverage is intended to work. Generally, it appears that OPP is handicapped in its efforts to make a transparent regulatory process by lack of a final rule on plant-pesticides.
The committee recommends that
EPA should promptly complete the process for issuing regulations, policies, and guidance that set out the system of review and regulatory parameters for pesticidal substances in transgenic pest-protected plants.
Clarity is critical in these issuances, and the agency should avoid the tendency to automatically fall back on policies and procedures that apply to traditional chemical pesticides. For example, EPA should move quickly to issue guidance on the data required for pesticidal substances in transgenic pest-protected plants regulated under FIFRA and FFDCA.
Under the coordinated framework, FDA considers some aspects of transgenic pest-protected plants under the general food safety clause and other provisions of FFDCA (section 4.1.2). With the exception of determining that it may require labeling for an allergenic plant-pesticide, FDA