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Current processes involved in biotech crop deregulation.
P. SPAINE (1), J. M. Cordts (1). (1) USDA/APHIS/Biotechnology Regulatory Services, Riverdale, MD, U.S.A.

USDA/APHIS has been one of three primary federal agencies involved with the regulation of genetically engineered organisms since 1987. Its primary roles relate to permitting to allow field trials of genetically engineered (GE) organisms and making determinations of non-regulated status, which can lead to eventual commercialization of products. The process of obtaining non-regulated status typically requires conducting one or more years of field research under APHIS’ oversight (a permit or notification) followed by submission of a Petition to the Agency documenting why the GE organism does not pose a plant pest risk. Typical data submissions include molecular and environmental characterizations that describe both the genotype (i.e., information about the inserted gene(s)) and phenotype of the organism. The phenotypic characterization typically includes a comparison with a closely related organism lacking the new gene(s) or with a representative range of related organisms as controls. Comparisons encompass a number of characteristics (e.g., growth habit, vigor, fecundity, outcrossing, reproduction, biotic and abiotic stress adaptations, cultivation practices, potential impacts on non-target organisms, etc.). Following a positive finding by the Agency, the organism may be moved and used in the environment without further APHIS oversight. Other U.S. government agencies involved in regulation of GE organisms include the FDA (assesses food safety) and the US EPA (deals with safe use of pesticides and pesticide labels).<p><p>Keywords:

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