Experts Say Bioengineered Corn May Have Caused a Number of Allergic Reactions

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Dec. 5, 2000 (Washington) -- A panel of experts convened to advise the EPA whether it should proceed with the retroactive approval of StarLink corn for human consumption told federal authorities Tuesday that it believed the corn may have caused allergic reactions in about seven people in the U.S.

StarLink is a bioengineered form of corn that was approved in 1998 for use as animal feed alone but has since accidentally contaminated a part of the nation's corn supply.

Aventis Crop Sciences, its maker, wants the EPA to grant StarLink a temporary approval for human consumption in order to avoid a recall that could affect as many as seven million bushels of corn. Although the company already has withdrawn the seeds from the market, the approval would provide sufficient time for those seven million bushels of corn to be processed, shipped, sold, and consumed.

The subsidiary of the Franco-German conglomerate, Aventis SA, made its case at a recent public meeting, at which it contended that the corn did not represent a threat to human health. But concerns have lingered on the parts of some federal regulators and activists alike.

StarLink corn contains a gene that helps the plant fight pests as it grows. The gene produces a protein, Cry9C, which exhibits some traits common to known allergens, or products that cause some people to have an allergic reaction.

Aventis Crop Sciences contends that animal studies and comparisons with other products known to cause allergic reactions show that Cry9C is unlikely to be an allergen. It also says the amount of StarLink corn currently on the market is so little that it could not trigger an allergic reaction even if Cry9C is proven to be an allergen.

The EPA supports the company's view that the overall potential exposure to Cry9C is extremely low -- in the range of parts per billion or trillion even for the most highly exposed individuals. But the EPA has questioned whether Cry9C has the potential to cause allergic reactions.

In its report, the panel said that more data was needed to establish a link, but "there is agreement that a number of these reports are likely to reflect true allergic reactions." The panel also said that it was "highly doubtful" that a lot more StarLink corn would be found in the U.S. food supply, especially in light of the recent withdrawal.

In a prepared statement, the EPA said it "will continue its evaluation of the scientific information, and develop the appropriate regulatory approach." The EPA also said that it was working with the FDA and USDA to investigate the remaining claims.

About 44 Americans claim to have had an allergic reaction to the gene-altered corn. After investigating these claims for the EPA, the CDC said that it considered about 11 of those cases to be possibly linked to a food allergy, although not necessarily to StarLink corn.

But any claims would strengthen the position of activist groups, who at least want the company to be punished for its failure to keep StarLink out of the human food chain, according to observers. These activists say that granting Aventis retroactive approval would shield it from possibly paying millions in damages.

Speaking at the recent public meeting, these activists implored the EPA and its expert panel not to reward Aventis for its mistakes. "EPA is charged with protecting human health and the environment, not rewarding illegal behavior," said Jane Rissler, a representative of the Union of Concerned Scientists, in a statement characteristic of other advocacy groups.

But for many, the debate surrounding StarLink extends beyond just Aventis and its failure to abide by its partial license to market the corn for animal feed alone. Regulators and industry representatives alike agree that the StarLink experience showed that drastic changes might now be needed to the nation's biotech regulations.

"In order to protect our domestic and foreign markets and ensure public confidence, its essential that we improve our ability to identify and track genetically modified products," said Agriculture Secretary Dan Glickman at a recent industry-sponsored conference. Glickman added that the USDA is now looking at a number of different options, including a ban on approving widely used commodities such as corn for animal consumption alone.

The EPA is expected to release its decision regarding Aventis' request for a temporary approval over the next few days.

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