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Historical perspective of regulation and deregulation of biotech crops.
S. A. TOLIN (1). (1) Virginia Tech, Blacksburg, VA, U.S.A.

Over 25 years have passed since recombinant DNA techniques were successfully used to introduce foreign genes into plants. Biosafety Level 3 was required to prevent release to the environment, which was prohibited by the early Guidelines for Research with Recombinant DNA Molecules promulgated by NIH under direction of the highest levels of the U. S. government. All Federal-funded research agencies were asked to comply with the NIH guidelines. This position resulted from intense scientific discourse ending in the compromise to assess and manage potential and conjectural risks by containment, but enabling research to continue. The USDA agreed, but pointed out that prohibiting release would preclude the power of biotechnology to agriculture. Useful discoveries in biotechnology in many areas were soon recognized as marketable products, resulting in an analysis of extant Federal Agency authorities for regulation of pharmaceutical, industrial and agricultural products. The 1986 Coordinated Framework for Regulation of Biotechnology clarified regulation of crop plants across three agencies, with approval of all needed prior to commercialization. Small scale field tests of plants was regulated by USDA-APHIS Plant Pest Quarantine and at first required permits from APHIS as well as EPA. Risk assessment and risk management discussions have continued, both nationally and internationally. Perspectives and results enabling deregulation will be presented.<p><p>Keywords:

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