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AGBIOTECH
Pharmaceutical production using bioengineered green plants, called "biopharming," is under heavy scrutiny now that regulators have found corn from private drug developer ProdiGene contaminating other crops. USDA and FDA are investigating the College Station, Texas-based company for possible violations of the Plant Protection Act.
What ProdiGene's corn plants were producing is being protected as confidential business information. FDA says only that it was a pharmaceutical material in clinical trials. USDA field-test permit records and company information indicate that ProdiGene's development programs include the protease inhibitor aprotinin, the simian immunodeficiency virus glycoprotein 120, the digestive enzyme trypsin, and other drugs and vaccines. ProdiGene has agreed to strengthen its controls on any plants it grows and is working out terms of an enhanced compliance program with USDA. FDA says the very small amount of genetically modified material in such a large quantity of soybeans would have posed "virtually no health risk," but says these products will not enter the food supply. The response has been immediate and mixed--reminiscent of two years ago when Aventis' StarLink corn, unapproved for human consumption, got into the food supply. The Biotechnology Industry Organization, National Corn Growers Association, American Soybean Association, and American Farm Bureau Federation have reiterated their support for producing drugs and industrial products in crops. Viewing the incident as a single company infraction, the organizations applaud the regulatory containment process. "There must be zero tolerance where public confidence in the integrity of the food supply is involved," BIO says. "This incident, however, should not overshadow the benefits of the emerging technology." Activist groups--including Greenpeace, Friends of the Earth, and Union of Concerned Scientists--are again criticizing biopharming pursuits (C&EN, Aug. 12, page 22). These groups believe regulations are inadequate to protect public health and the environment and are calling for an immediate halt to all field trials. USDA and FDA, however, emphasize that increased safeguards are in place. BIO, whose members include dozens of firms conducting field tests, has adopted a strict ban on biopharming in food-producing areas. |
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