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CSPI Says Industry & Regulators Sowing Secrecy in America's New 'Pharm Belt'

The controversial practice of using genetic engineering to grow drugs or industrial chemicals in food crops is picking up speed, according to a new report from the Center for Science in the Public Interest (CSPI). While a 2002 scandal involving an errant biopharm crop from Prodigene temporarily put the brakes on the practice, the Department of Agriculture (USDA) has received 16 new applications for biopharming permits in the past 12 months. About two-thirds of those applications involved a food crop such as corn, rice or barley, but virtually every other salient detail about the application—-sometimes even the name of the drug or chemical being produced—-is shielded from public view.

"It is impossible to know whether these biopharmed crops present any food-safety or environmental risk, since the whole process is shrouded in secrecy. Even the Food and Drug Administration is out of the loop," said Gregory Jaffe, director of CSPI's biotechnology project and the author of the report. "What is clear is that the biopharming industry has been given a big green light by federal regulators, even though there is great concern among food producers and consumers about using food crops to produce drugs."

According to the report, six permit applications involved genetically engineered (GE) corn, two involved GE barley, and one permit application each involved GE rice, safflower, and Indian mustard. Five permits involved tobacco, a non-food crop. Although the public portions of the permit applications do not disclose the proposed acreage of the crop, they do list states. Four permit applications identified Kentucky as the location; three identified Texas; Missouri, South Carolina, California, and Iowa were each identified on two applications; Hawaii, Florida, Washington, Nebraska, and Arizona were each identified on one.

Prodigene, which in 2002 was fined by USDA for allowing experimental GE corn to contaminate soybeans headed for the food supply, submitted four of the most recent applications—to produce pharmaceuticals in corn in Nebraska and Texas. Judging from USDA's past record, CSPI anticipates that most of the outstanding permit applications will be approved.

Nothing in the public portions of the applications details whether the permit would be for a field trial or for full-scale commercial production. Nor do the applications fully disclose which organism's genes are being spliced into the crop or what substance the company hopes to produce. Some firms' web sites do at least hint at the proposed crop: Prodigene is advertising two products, grown from transgenic corn, with pharmaceutical applications, trypsin and aprotinin. Another company, Ventria Bioscience, wants to grow rice that contain human genes in order to commercially produce the proteins lactoferrin and lysozyme.

Major manufacturers of processed foods, many of whom embrace applications of agricultural biotechnology that improve crop yields or breed resistance to insects, oppose using important food crops like corn to grow drugs. In 2002 the National Food Processors Association said that it "finds there is an unacceptable risk to the integrity of the food supply associated with use of food and feed crops as 'factories' for the production of pharmaceutical or industrial chemicals." Similarly, the Grocery Manufacturers of America strongly recommends that non-food crops be used for biopharming.

"When non-food crops like tobacco can be used for biopharming, it is unnecessarily risky to use crops like corn or rice without a much stronger and more transparent regulatory system," said Jaffe. "It would be a public relations catastrophe for both the biotechnology industry and the food industry if even minuscule amounts of vaccines or other drugs ended up in cereal."

CSPI's report recommends that food crops should not be used for biopharming unless protection could be assured through a strong regulatory system. CSPI also recommends that USDA conduct environmental risk analyses before permits are issued, and that FDA conduct food-safety risk analyses if a food crop is to be used to produce substances commercially. And, says CSPI, the entire permit process should be open and transparent.

While CSPI advocates for strict regulatory oversight of genetically engineered crops, it believes that agricultural biotechnology holds great promise for human health and the environment.


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