24 April 2001

EPA Makes Public New Data on StarLink Corn and Food Processing

The U.S. Environmental Protection Agency (EPA) made public new data from the maker of a genetically modified variety of corn known as StarLink that suggests that "potential exposure to the StarLink corn protein in finished food products is significantly lower than previous estimates," according to an April 24 EPA press release.

The data from Aventis Crop Sciences, EPA says, indicates that "the process of wet-milling corn effectively eliminates StarLink protein from finished food products," and "the dry-milling process denatures but does not completely eliminate the presence of StarLink protein in the finished food products."

The EPA wants data on the potential levels of StarLink corn protein in finished food products because it is evaluating a request from Aventis to authorize the use of StarLink corn in the human food supply. It is currently allowed only for animal use. Among the unresolved issues are whether the protein in StarLink could cause allergic reactions in people, and whether the protein is destroyed in the food manufacturing process.

Small amounts of the StarLink protein have been found in some products such as taco shells (which were recalled from the market); additionally, small amounts of corn containing StarLink protein have been found mixed in with regular corn seed.

EPA said it continues to review Aventis' request; it will evaluate this new data as well as an investigation into complaints of people who think they may have had allergic reactions from eating products containing the corn.

The new information on StarLink corn submitted by Aventis is available at: http://www.epa.gov/pesticides/biopesticides

Following is the text of the EPA press release:

U.S. Environmental Protection Agency
Washington, D.C.

04/24/2001

New Data on Starlink Corn Available;
Federal Government Continues Comprehensive Investigation

New data concerning the levels of StarLink corn protein in processed foods have been submitted to EPA from Aventis Crop Sciences, and are being made publicly available. The new information appears to confirm the Agency's assessment that the process of wet-milling corn effectively eliminates StarLink protein from finished food products such as corn oil, corn syrup, alcohol, and corn starch. The data also appear to provide new information on the potential levels of StarLink corn protein in finished food products derived from the corn dry-milling process. According to Aventis' findings, for test products made from 100 percent StarLink corn, the dry-milling process denatures but does not completely eliminate the presence of StarLink protein in the finished food products. EPA will carefully evaluate this new information as it continues to review Aventis' pending request to authorize StarLink corn in the human food supply.

The new information is likely to be an important addition to the growing body of scientific data on the potential allergenicity of StarLink corn protein. EPA sought guidance concerning the scientific assessment of StarLink corn in the food supply from the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP) in a Nov. 28, 2000 meeting. The Dec. 5 report for this meeting stated that additional data were needed to more accurately assess the potential exposure to StarLink corn protein in finished food products. Aventis' new data appear to indicate that potential exposure to the StarLink corn protein in finished food products is significantly lower than previous estimates.

Pending a comprehensive evaluation of all scientific information available on human health concerns related to StarLink corn, EPA, the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) are continuing to coordinate an aggressive Federal effort, in cooperation with growers, millers, the food industry and Aventis, to divert StarLink corn away from the human food supply. USDA has been very successful working with growers and seed companies to ensure that bags of corn seed intended for the 2001 growing season are tested for the presence of StarLink corn and are not planted if found to contain StarLink. FDA and the Centers for Disease Control and Prevention (CDC) are continuing their investigation of cases in which people reported experiencing allergic reactions from eating corn products. Results of this investigation are expected later this Spring and will be made publicly available.

EPA will use the Aventis data as well as the results of the CDC work and all other available data related to StarLink in evaluating the company's tolerance petition. EPA will continue to make all new information available to the public and will obtain appropriate scientific peer review as part of any decision. The federal government is committed to ensuring that the U.S. food supply is safe for all citizens. The new information on StarLink corn submitted by Aventis is available at: http://www.epa.gov/pesticides/biopesticides.

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