EPA unconvinced on StarLink bio-corn safety

Julie Vorman / Reuters 14nov00

New scientific data submitted by the maker of StarLink corn does not dispel government scientists' concerns that the gene-altered crop may cause allergic reactions in humans, the Environmental Protection Agency said Monday.

In what it described as a preliminary evaluation and not a final ruling, the EPA said it still questioned Aventis SA's contention that StarLink poses no allergic risk.

But the agency also said new data submitted by Aventis supports an overall conclusion that the potential dietary exposure of humans to StarLink in corn flour, chips and other processed foods is "extremely low."

Along with its 26-page preliminary assessment, the EPA published a list of questions about the safety of StarLink that it wants a panel of independent scientists to consider before giving their recommendation to the agency on Dec. 1.

The EPA approved the corn for use only as livestock feed in 1998 after agency scientists said they could not determine if StarLink might cause allergic reactions in humans.

Traces of the corn were found in taco shells in September, triggering a recall of more than 300 brands of foods, broad testing of raw corn supplies and complaints from overseas buyers that American corn shipments may be contaminated.

Aventis asked the EPA last month to grant a four-year temporary approval for the bio-corn to be used in human food, a period of time needed for existing corn to make its way from food production plants to consumers' pantries. As part of that request, Aventis submitted new science data which it said showed the corn did not pose a human health risk.

EPA Lays out science issues

The EPA, which is under pressure from anti-biotech activists as well as the food industry, emphasized that no decisions would be made until the scientific advisory panel has considered the issue at a public hearing set for Nov. 28.

"The issue before the scientific advisory panel is whether or not the presence of the StarLink corn in the human food supply, in finite quantities and for a limited time duration, poses an unacceptable risk of allergenicity," it added.

A key issue for the EPA's science advisory panel to consider is how to judge the likelihood of StarLink and its unique protein known as Cry9C causing allergies in humans.

The EPA questioned Aventis' comparison of StarLink to allergens like peanuts or wheat, saying there was no scientific basis to conclude whether the corn behaves in the same way.

In order for a person to have an allergic reaction — such as skin rashes, diarrhea or respiratory problems — he or she must first become sensitized to that protein. The sensitization comes after being exposed to a protein at high enough concentrations and over an extended period of time.

The government is currently investigating more than a dozen complaints of allergic reactions from people who said they ate foods containing StarLink. That information will be made public at the Nov. 28 meeting, the EPA said.

The EPA also disagreed with Aventis' estimate of how much StarLink has contaminated total U.S. corn supplies.

Aventis, which is spending $100 million to buy back what remains of this year's harvest, cannot account for six percent of the crop or about 4.8 million bushels, the EPA said. The agency said it was reasonable to assume that was mixed with 3.4 billion bushels of other yellow corn, meaning there was 0.14 percent contamination of corn used in the human food supply.

The EPA also repeated its long-held view that there was no allergic risk to humans from eating meat, eggs and milk from animals that may have been fed StarLink corn.

Aventis: Little Threat to Human Health

Aventis, the European-based pharmaceutical and life sciences company, said the EPA preliminary assessment acknowledged there was little threat to human health.

"We will continue to be as responsive as possible and we note that the EPA has confirmed that the risks of an allergic reaction in people to food containing StarLink corn, if any, are extremely low," a company spokeswoman said.

The Genetically Engineered Food Alert, a coalition of green groups, said the EPA report indicated the agency rejected much of the Aventis science data.

"The EPA still doesn't know whether StarLink is an allergen," said Larry Bohlen, a spokesman for the coalition. "Aventis has failed to prove that StarLink does no harm to health. The agency said that Aventis makes a faulty comparison in saying that the StarLink protein level has to be as high as the peanut protein level to cause an allergy."

The uncertainty over StarLink has rattled U.S. commodity markets. On Monday, December corn futures traded on the Chicago Board of Trade fell 3/4 to close at $2.11-1/4 per bushel.

Japan, the single biggest buyer of American corn, has halted most purchases of U.S. shipments for the first quarter of 2001 because of fears that the cargoes may be contaminated. The USDA has promised to begin testing shipments this week, but Japanese importers said they remained concerned.

The EPA also said it hopes to soon announce the names of the dozen scientists on the special panel to review whether StarLink causes allergic reactions. The panel members will be announced after all have submitted financial disclosure forms showing whether they have accepted research funding from food companies or environmental groups, the EPA said.

StarLink was developed by Aventis with a gene inserted to fight destructive pests that feed on young corn plants.