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Implications of pollen research to APHIS pharm corn regulations

(Monday, Sept. 9, 2002 -- CropChoice news) --

Information Systems for Biotechnology News Report, Gene Stevens, via AgNet: Development and subsequent testing of plant-made pharmaceutical (PMP) crops is proceeding at a steady pace. Corn (maize) and tobacco have received the most attention as potential green factories for producing medicines and vaccines. Several government agencies are regulating the testing, production, and disposal of these crops to assure that safe manufacturing practices are followed. The United States Department of Agriculture's Animal and Plant Health Inspection Service (APHIS) has developed rules for preventing dissemination into the environment of organisms engineered for pharmaceutical products. APHIS permits for field tests with PMP crops are issued on a case-by-case basis. On May 21, 2002, APHIS posted a summary of their confinement requirements for organisms containing pharmaceutical genes being field tested (barley, corn, rice, sugarcane, tobacco, and tobacco mosaic virus). The report can be downloaded at http://www.aphis.usda. gov/ppq/biotech/pdf/pharm-2002.pdf. An important element of the APHIS regulations is achieving reproductive isolation of PMP plants from plants of the same species or sexually compatible species. In 2002, applicants seeking APHIS permits for growing pharmaceutical corn had three options available for mitigating pollen-mediated cross-pollination or gene flow. Each option has strict guidelines concerning isolation distance and planting dates of PMP corn relative to other cornfields in the area.