Ag department keeps secrets of biopharm crops

WASHINGTON, DC, June 3, 2004 (ENS): The use of genetic engineering to grow drugs or industrial chemicals in food crops is gaining ground, according to a new report from the Center for Science in the Public Interest (CSPI), nonprofit health advocacy group.

The U.S. 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 no other detail about the application, including the name of the drug or chemical being produced, is kept from the public.

"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," Jaffe said.

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.

"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."

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.

Nothing in the public parts 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.

Judging from USDA's past record, the CSPI expects that most of the outstanding permit applications will be approved. 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.

The CSPI's report recommends that food crops should not be used for biopharming unless protection is assured through a strong regulatory system. The group also recommends that the USDA conduct environmental risk analyses before permits are issued, and that the Food and Drug Administration conduct food safety risk analyses if a food crop is to be used to produce substances commercially.

An incident in 2002 set alarm bells ringing even for major manufacturers of processed foods who may support genetic engineering to improve crop yields or resist insects. The U.S. Department of Agriculture’s Animal and Plant Health Inspection Service identified two violations of ProdiGene, Inc.’s field test permits - one in Nebraska and another in Iowa. Volunteer corn in both locations contained traces of unidentified biopharmaceuticals from 2001 field trials.

The National Food Processors Association said at the time 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."

Grocery Manufacturers of America (GMA) Director of New Technologies and Environment Karil Kochenderfer said at the time, “These incidents reaffirm GMA’s concerns about the use of food crops for the development of plant-made pharmaceuticals.”

The CSPI report, "Sowing Secrecy: The Biotech Industry, USDA, and America’s Secret Pharm Belt" is online at:

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