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http://www.nytimes.com/2002/12/07/science/07GENE.html?tntemail0

Spread of Gene-Altered Pharmaceutical Corn Spurs $3 Million Fine

By ANDREW POLLACK

biotechnology company will pay the government about $3 million to settle charges that it did not take proper steps to prevent corn that was genetically engineered to produce pharmaceuticals from entering the food supply.

The company, ProdiGene, agreed to pay a civil fine of $250,000 and to reimburse the government for buying and incinerating 500,000 bushels of soybeans contaminated with the genetically modified corn. The fine is the first ever for violation of a permit for a field trial of a genetically engineered crop, government officials said yesterday.

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The incident has raised concerns among environmentalists and food companies about a fledgling area of biotechnology, implanting genes in crops to make them produce pharmaceuticals or industrial chemicals. Until now, genetic engineering has been used mainly to make crops resistant to insects or herbicides.

Biopharming, as it is sometimes called, may one day be an inexpensive way to produce large volumes of certain proteins, like insulin for diabetes or antibodies to treat cancer, that are now made in vats of genetically modified cells. The technology may also be used to make vaccines that can be eaten rather than injected. But if such crops were to become intermixed with food crops, they could pose a health hazard and require huge food recalls.

Officials of the Department of Agriculture and the Food and Drug Administration said yesterday that ProdiGene's corn never made it into food or animal feed. That, plus the fine, shows the system is working, they said. "I think this demonstrates the rigor of our regulatory system," said Bobby Acord, administrator of the agriculture agency's Animal and Plant Health Inspection Service.

But a spokeswoman for the food industry, while applauding the fine, said concerns remained. "The incident over all just reaffirms our concerns that something could go wrong," said Stephanie Childs of the Grocery Manufacturers of America, which represents food companies like Kellogg and General Mills. The organization wants pharmaceuticals to be grown in plants that are not used for food, but the biotech companies say that would be impractical.

ProdiGene, a private company based in College Station, Tex., has been one of the most aggressive companies in the new field and already sells some industrial chemicals produced in genetically modified corn. It was accused of two incidents of possible contamination.

In one case, soybeans were planted this year on a plot in Nebraska that was used last year to grow genetically engineered corn. Some corn stalks sprouted from seed still remaining in the ground, and the company failed to destroy them. About 500 bushels of soybeans were contaminated with a small amount of the corn. But those 500 bushels were then mixed in a grain elevator with 500,000 bushels.

In the second incident, ProdiGene corn growing in Iowa was feared to have cross-pollinated with corn in nearby fields. So the company was required to burn 155 acres of corn.

The product grown in the corn is a protein to be used as a vaccine to prevent diarrhea in pigs.

Under its consent decree, ProdiGene agreed to post a $1 million bond to pay for problems arising from any possible future infractions. It also agreed to train all its employees about regulations and to undergo more stringent inspections. "We have learned some valuable lessons," Anthony G. Laos, the company's president, said in a statement.

Some biotech executives said privately that ProdiGene's behavior undermined confidence in the entire industry. The biotech companies are in a tight spot, with food companies, normally supporters of genetically modified crops, now siding with environmentalists in asking that food crops not be used to make pharmaceuticals.

The Biotechnology Industry Organization, a trade group, recently proposed voluntary guidelines to keep the pharmaceutical corn from being grown in the Corn Belt. But politicians from Iowa objected, saying that such a restriction would keep farmers from taking part in a big new business. So the biotechnology organization has now changed its guidelines so that no region is automatically off limits.

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