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GENETICALLY MODIFIED PEST-PROTECTED PLANTS: SCIENCE AND REGULATION
Finally, the proposed rule would establish several exemption categories, but does not offer any opportunity for an applicant to seek an exemption for an individual product. Given the dynamic nature of the technology, products with unique characteristics and use patterns that might warrant specific exemptions probably will be developed within the next 5 to 10 years. Without a mechanism to address these individual products case by case, a time-consuming rule-making process would be required to establish one or more new exemption categories. The committee also recommends that
EPA's rule should establish a process for applicants that do not qualifyfor an existing exemption to consult with the agency and seek anadministrative exemption on a product-by-product basis when the pesticidalsubstance in the plant does not warrant registration. The processshould be transparent, with sufficient information made availableto allow subsequent applicants to benefit.
For a substance to qualify for exemption from FIFRA requirements in the proposed rule, EPA would require any person who sells or distributes it to notify the agency of any new information concerning potential adverse effects on human health or the environment associated with the product (EPA 1994a). That provision would, for the first time, require nonregistrants to comply with a reporting obligation imposed by statute on registrants (FIFRA § 6(a)(2); US Congress 1947, section 136d(a)(2)). Although little attention has been directed to the impact of this proposal, it would probably apply to many plant breeders, researchers and seed distributors that work with conventional pest-protected plants and have never been subject to FIFRA or EPA jurisdiction. The proposed rule does not assess the potential for taking advantage of monitoring systems that use federally funded insect surveys, independent crop consultants, and USDA extension agents to identify potential adverse effects associated with conventional pest-protected plants and other crops. The committee recommends that
EPA should publicly reexamine the extent to which FIFRA adverse effectsreporting is intended to apply to plant breeders, researchers, andseed distributors of conventional pest-protected plants who havenever been subject to FIFRA or EPA jurisdiction. For products thatmeet the definition of a pesticide but are exempt from registrationunder FIFRA, EPA should review the extent to which existing fieldmonitoring systems could substitute for traditional FIFRA reportingrequirements.