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GENETICALLY MODIFIED PEST-PROTECTED PLANTS: SCIENCE AND REGULATION
process should be transparent, with sufficient information made availableto allow subsequent applicants to benefit.
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.
USDA should clarify the scope of its coverage as there are some transgenicpest-protected plants that do not automatically meet its currentdefinition of a plant pest.
EPA and FDA should develop a memorandum of understanding (MOU) thatestablishes a process to ensure a timely exchange of informationon plant-expressed pesticidal substances that are potential foodallergens. The MOU should articulate a process under which the agenciescan regulate potential food allergens in a consistent fashion— byEPA through tolerance setting and by FDA through food labeling.
EPA, USDA, and FDA should develop a memorandum of understanding fortransgenic pest-protected plant products that provides guidance toidentify the regulatory issues that are the purview of each respectiveagency (for example, ecological risks and tolerance assessment forEPA, plant pest risks for USDA, and dietary safety of whole foodsfor FDA); identifies the regulatory issues for which more than oneagency has responsibility (for example, gene transfer for EPA andUSDA and food allergens for EPA and FDA); and establishes a processto ensure appropriate and timely exchange of information betweenagencies.
Where regulation is not warranted, agencies should look for appropriateopportunities to promote nonregulatory mechanisms to address issuesassociated with transgenic pest-protected plant products, includingencouraging development of voluntary industry consensus standardsand product stewardship programs.
FDA should put a high priority on finalizing and releasing preliminaryguidance on the assessment of potential food allergens, while cautioningthat further research is needed in this area.