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Pharma Crops: Going to "Great Lengths" to Prevent the Escape of Genes That Produce

Going to "Great Lengths" to Prevent the Escape of Genes That Produce
Specialty Chemicals

Norman C. Ellstrand
Department of Genetics and Biotechnology Impacts Center, University of
California, Riverside, California
92521-0124

In late 2002, the U.S. Department of Agriculture (USDA)'s Animal and Plant Health Inspection Service
(APHIS), the agency that regulates field release of genetically engineered (transgenic) plants, found
that the biotechnology company ProdiGene, Inc. failed to follow government regulations for growing
genetically modified (GM) corn (Zea mays), engineered to produce a specialty pharmaceutical protein, in both Iowa and Nebraska.

In Iowa, pollen from the corn designed to produce a pig vaccine might have pollinated nearby crops, leading to a government order of the incineration of 63 ha of corn growing near the experimental site. In Nebraska, engineered seed from the previous year's experiment germinated and grew as "volunteer corn" in a field of soybeans (Glycine max). The beans were subsequently
harvested and transported to storage. Despite an APHIS inspector's request to collect/destroy the corn before the harvest of soybeans, some of those corn plants were harvested as well and ended up mixed with more than 17.5 million L (a half-million bushels)
of stored soybeans.

ProdiGene received a fine of $250,000. In addition, the USDA required it to buy
and destroy the soybeans containing the GM corn at an approximate cost of $3.5 million. A penalty of this magnitude is the first of its kind for the U.S. government to levy against an agricultural biotechnology company, and it is not clear that the relatively small
company will be able to pay the entire cost (Gillis, 2003).

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