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| Biotech Updates |
| EPA Mulls Decision on StarLink Following Advisory Panel Reveiw of the Potential Allergenicity of the Cry9C Protein - December 22, 2000 |
| The US EPA is currently considering a petition from Aventis, the maker
of StarLink corn, for a four-year exemption from tolerance for the "plant-pesticide"
Cry9C protein and the Cry9C gene.
StarLink corn is currently
not approved for use in human food because of concerns over the potential
allergenicity of the Cry9C protein.
The EPA's independent Scientific Advisory Panel concluded in a report dated December 1 and released December 5 that "there is a medium likelihood that the Cry9C protein is a potential allergen based on the biochemical properties of the Cry9C protein itself-not its levels in the food supply." The panel also concluded that "the likely levels of Cry9C protein in the US diet provide sufficient evidence of a low probability of allergenicity in the exposed population." StarLink corn resists some insect pests because the corn produces Cry9C protein. EPA regulates the Cry9C protein as a "plant-pesticide." Under federal law, Aventis must show a "reasonable certainty of no harm" from the Cry9C protein. The sticking point in the review has been the unresolved issue of the potential allergenicity of the protein.Cry9C is new to the food supply, and since there is no laboratory test that can predict if a new protein will be a food allergen, EPA has called on a Scientific Advisory Panel of scientists, physicians and corn processors to assesss the potential allergenicity of the protein. The FDA is now following-up on reports from about 20 people who had allergic-like reactions after eating foods that included corn. Blood samples from those people who wish to be tested will be checked for antibodies that stick specifically to the Cry9C protein, a further step inthe process of determining if the Cry9C protein is involved or not. Final results are not expected until February or March. In 1998 EPA approved the use of StarLink corn but only for use in the US and only for use in animal feed and industrial products, but not in human food. This has been the only "split-approval" of a crop variety developed using biotechnology.On September 18 the environmental group Friends of the Earth announced that tests they commissioned detected Cry9C DNA in taco shells, indicating that StarLink corn had gotten into the human food supply. This discovery triggered food recalls and disrupted the domestic and international corn markets as farmers, shippers, processors and government agencies tracked down corn shipments contaminated with the unapproved StarLink variety.EPA Office of Pesticide Programs: http://www.epa.gov/pesticides
USDA Biotechnology Site: http://www.usda.gov/agencies/biotech/index.html
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| For more information, contact:
Tom Zinnen 425 Henry Mall Madison WI 53706 608-265-2420 zinnen@biotech.wisc.edu |
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