The US government looks unlikely to bow to demands from Aventis that it temporarily approve the company's genetically modified StarLink corn for human consumption, following the inadvertent and embarrassing release of the strain into the food chain.
The US Environmental Protection Agency (EPA) appears unimpressed by data submitted in support of the request by Aventis, the North Carolina-based manufacturer of the corn. The EPA's preliminary evaluation questioned the company's interpretation of studies on the potential for allergic reactions to the corn.
The EPA made its assessment in preparation for a public meeting near Washington on 28 November at which it will solicit comment from the public and from a panel of scientists. The regulatory agency will receive the panel's final recommendations on 1 December.
A coalition of US environmental groups concerned about genetically engineered foods initiated the furore in mid-September when their tests found traces of StarLink DNA in taco shells. The discovery led to a massive recall of more than 300 food brands.
The submission of new data is part of a petition by Aventis to allow StarLink corn to be present temporarily in processed foods, to avoid more recalls of products already on the market, says a company representative.
Debate over this strain of corn has been heated. The strain, approved in 1998 for use in animal feeds, is engineered to produce an insecticidal protein related to others already in widespread use. But the protein, Cry9C, does not break down at certain temperatures and conditions, which has caused alarm about its potential to trigger human allergies.
Despite these concerns, an Aventis spokesman says the company is convinced that StarLink will not cause allergic reactions. Another Aventis representative, Rhonda Barnat, adds: “This is a technical regulatory issue, not a product safety issue.”
The EPA has criticized the company's analysis of the new data. EPA official Stephen Johnson says: “We don't think they have provided us with sufficient information [on the allergy issue].” The EPA also finds fault with the way Aventis determines allergic potential and uses peanut protein, a potent allergen, as a measure of safety.
“It is clear that the company violated its licence and that is an outrage to us,” says Johnson, adding that the agency needs to review the new information further before making any final decisions.
Taiwan also reports finding StarLink in corn grits, says Tim Galvin, an official at the US Department of Agriculture's Foreign Agricultural Service. And Japan has found the variety, which it had not approved, in 10 of 15 samples of a baking product.
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Nature Biotechnology (2005)
A human dendritic cell-based method to identify CD4+ T-cell epitopes in potential protein allergens.
Environmental Health Perspectives (2003)