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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. | |
