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New StarlinkT Corn Data Submitted by Aventis CropSciences - 4/23/01

Information provided for informational purposes only

Note: This information is provided for reference purposes only. Although the information provided here was accurate and current when first created, it is now outdated.

In this document, the reader will find the report of a new study conducted by Aventis CropSciences, the registrant of StarLink corn. Aventis conducted this study in part to provide additional information for the Environmental Protection Agency's (EPA) scientific assessment of the potential allergenicity of StarLink corn protein in finished food products. On December 5, 2000, the Scientific Advisory Panel, a group of independent scientific experts, expressed the need for additional data to more accurately assess the potential allergenicity of StarLink corn protein. Specifically, the Panel indicated that it would need more data on the precise amount of StarLink corn protein in processed foods, such as taco shells, corn muffins and grits.

When the Panel considered these issues, analytical methods were not available to detect levels of StarLink corn protein in processed foods. The validated procedures available at the time only had the capability of detecting StarLink corn protein in raw corn, and of detecting the DNA that encodes for the StarLink corn protein in processed foods. A private laboratory has developed a new analytical method that, reportedly is more sensitive than the protein strip test being used for corn grain.

In the attached study, Aventis examined how two types of corn processing affected the amount of StarLink protein in processed foods. Wet-milling renders corn into corn oil, corn syrup, alcohol, and corn starch. Aventis reports that it has found that the wet-milling process reduces the residues of the StarLink corn protein in finished food products to a level that is below the limit of detection for its analytical method. This finding is consistent with scientific literature, as well as the findings of EPA's recent assessment of wet-milling. Dry-milling renders corn into corn grits, corn flour and masa. According to Aventis= findings using test products made from 100% StarLink corn, the dry-milling and subsequent processing appear to denature, but not completely eliminate, the presence of the StarLink corn protein in the finished food products. Aventis reports that its new data indicate lower exposure estimates than what the Agency had estimated in its assessment last Fall.

EPA is now reviewing this study, and will solicit scientific peer review from independent scientists known for their expertise in this field.

 Volume 1   Administrative Materials (576kb PDF)
 Volume 2   Estimated Potential Dietary Intake of Cry9C Protein Based on Measurements of Cry9C In Processed Foods Made From 100% StarLink Corn (869kb PDF)
 Volume 3   Development of ELISA Assays to Detect Cry9C-Specific IgG and IgE Antibodies in Human Serum (478kb PDF)
 Volume 4   Letter from Aventis to Administrator Whitman, Secretary Veneman and Dr. Schwetz (97kb PDF)
  Aventis Position on Follow Up with Individuals Alleging Allergic Reactions to Corn Ingestion (142kb
PDF)
 Volume 5   Detection of Cry9C Protein in Dry Milled, Wet Milled and Masa Processed Fractions and Processed Foods Made From 100% StarLink Grain (10,930kb PDF)
 Volume 6   StarLink Corn Containment Program (739kb PDF)
 Volume 7   The Aventis CropScience StarLink Quality Plan for Corn Dry Mills (391kb PDF)

 

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