bers (see appendix A4). From this analysis, the committee found that regulation of transgenic pest-protected plants under the coordinated framework and EPA's proposed plant-pesticide rule might affect small to medium-size seed companies, public sector breeders, and other small developers who are not accustomed to the testing and regulatory submissions. Therefore, the committee recommends that
Regulators should be sensitive to the unique issues facing researchers, plant breeders, and seed distributors, particularly those in the public sector or those who have not traditionally been subject to federal regulation.
Regulatory agencies should aggressively seek to reduce regulatory costs for small biotechnology startup companies, small to medium size seed companies, and public sector breeders by providing flexibility with respect to data requirements, considering fee waivers wherever possible, and helping these parties navigate their regulatory system.
EPA's rule and preamble should clearly restate the agency's position that genetically modified pest-protected plants (that is, plants modified by either transgenic or conventional techniques) are not subject to regulation as pesticides. EPA must remain sensitive to the erroneous perception that plants are being regulated as pesticides.
EPA should make explicit a process for the periodic review of its regulations on the basis of new information or changed circumstances to identify additional categories of pesticidal substances expressed in plants that should be exempt from regulatory requirements and existing exemptions that should be revoked or restricted.
EPA's rule should establish a process for applicants that do not qualify for an existing exemption to consult with the agency and seek an administrative exemption on a product-by-product basis when the pesticidal substance in the plant does not warrant registration. The
This appendix was authored by an individual committee member and is not part of the committee's consensus report. The committee as a whole may not necessarily agree with all of the contents of appendix A.