Approval Process of Genetically Altered Crops Questioned

Medically Reviewed by Charlotte E. Grayson Mathis, MD
From the WebMD Archives

Oct. 13, 2000 (Washington) -- Genetically engineered corn meant for animal feed, but found in taco shells, is beginning to force changes in industry and government.

New legislation has been introduced in Congress to require the FDA to conduct mandatory tests on genetically modified foods. And that genetically engineered brand of corn not approved for human consumption has now been withdrawn from the U.S. market, which, current legislation aside, raises questions about why it was ever approved and whether government regulators responded appropriately to reports that traces of the corn were found in human food.

The Environmental Protection Agency (EPA) said Thursday that Aventis CropScience agreed to cancel its previously granted license to sell Starlink, a genetically engineered corn meant for animal feed. The federal agency said the withdrawal was necessary because Aventis had failed to ensure that the corn would not appear in human food.

The health risks "are extremely low," the EPA said in a prepared statement. However, "Aventis was responsible for ensuring that Starlink corn only be used in animal feed, and that responsibility clearly was not met," the federal agency said.

Traces of the corn recently have been discovered in several brands of taco shells. The latest traces were discovered in taco shells sold by Safeway Inc., which on Wednesday announced its intention to remove all taco shells from its stores after learning about the test results. In late September, a similar recall was announced by Kraft Foods, whose Taco Bell brand shells also tested positive for the presence of the genetically engineered corn.

Prior to canceling its license to sell Starlink, Aventis suspended sales of seeds for next year's crop and agreed to purchase all of this year's harvest, or about 300,000 acres of corn. But despite the response by the government and industry, the withdrawal is raising further concerns about the current approval process for genetically engineered crops.

Proponents of stronger regulations want the FDA to require premarket testing of genetically engineered crops, as well as require the mandatory labeling of products subsequently approved for sale in the U.S. They say that the recent recalls underscore the need for tougher regulations.

The corn should have never been approved for sale in the U.S. without first being tested, Bill Freese, a policy analyst with Friends of the Earth (FOE), tells WebMD. "That was totally irresponsible," says Freese, whose group played a lead role in calling for the corn's withdrawal.

The corn contains a synthetic protein that makes it toxic to insects. That protein also is resistant to stomach acids and enzymes, an indication that it also could cause potential allergic reactions in humans.

"This has been a massive experiment on the public, for which we may never know the results," Freese says. "We shouldn't have to look for dead bodies."

Freese adds that FOE and federal officials have received some reports from people that have fallen ill after eating the corn. But others are questioning whether the recall was necessary and who eventually will end up paying for the nationwide hunt.

"Frankly, I would give it approval for human consumption based on the data we have today," says Robin Woo, PhD, deputy director of Georgetown University's Center for Food and Nutrition Policy.

Woo points out that the corn probably was included in taco shells for some time prior to the recall, and as a result, already has been consumed by numerous people. "The corn was not approved for human consumption because we didn't know the effects, but we now clearly know that there is nothing wrong with the stuff," she tells WebMD.

Woo says that the cost of the recalls probably will come directly out of consumers' pockets. "This has been a knee-jerk reaction that could drive up the cost of these products," she tells WebMD.

Further testing is now being done on additional products, and the U.S. Department of Agriculture estimates that the entire process could cost Aventis as much as $100 million. But in a prepared statement, the company said it is pursuing the recall because it wanted to err on the side of caution.

The corn flour used in both the Kraft and Safeway taco shells was bought from the same company, Azteca Millings of Irving, Texas, a joint venture of agricultural giant Archer Daniels Midland Co. of Decatur, Ill., and Mexico's Gruma S.A.

In related news, Sen. Richard Durbin (D-Ill) has now introduced legislation that would require the FDA to conduct mandatory tests on genetically modified foods. The bill would apply to both domestic and foreign products, and also would authorize the FDA to test products on supermarket shelves to determine if unapproved materials are entering the food supply.

Under the current regulations, the FDA only requires testing of food products that were genetically altered with a known allergen. That has happened only once before, when life sciences giant Dupont created a version of soybeans containing a protein from the Brazilian nut for animal feed. The company quickly abandoned the soybeans after concerns emerged regarding whether these soybeans would enter the human food supply and possibly cause an allergic reaction.

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