Biotechnology Consultation Agency Response Letter BNF No. 000109

Return to inventory: Completed Consultations on Foods from Genetically Engineered Plant Varieties

See also Biotechnology: Genetically Engineered Plants for Food and Feed and about Submissions on Bioengineered New Plant Varieties

See FDA's memo on BNF No. 000109 for further details

CFSAN/Office of Food Additive Safety

September 29, 2008

Dr. Alejandra Scott
Bayer CropScience LP
P.O. Box 12014
Research Triangle Park, NC 27709

Dear Dr. Scott:

This is in regard to Bayer CropScience USA LP's (Bayer) consultation with the Food and Drug Administration (FDA) (Center for Food Safety and Applied Nutrition and Center for Veterinary Medicine) on its genetically engineered cotton event GHB614. According to Bayer, cotton event GHB614 is engineered to express a new protein, a double-mutant 5-enolpyruvylshikimate 3-phosphate synthase protein (2mEPSPS). The 2mEPSPS protein confers tolerance to the herbicide glyphosate. All materials relevant to this notification have been placed in a file designated BNF 0109. This file will be maintained in the Office of Food Additive Safety.

As part of bringing the consultation regarding this product to closure, Bayer submitted a summary of its safety and nutritional assessment of the genetically engineered cotton dated December 12, 2006. Bayer submitted additional information on June 6, 2007, January 18, 2008, February 29, 2008, and July 31, 2008. These communications informed the FDA of the steps taken by Bayer to ensure that this product complies with the legal and regulatory requirements that fall within FDA's jurisdiction. Based on the safety and nutritional assessment Bayer has conducted, it is our understanding that Bayer has concluded that cottonseed and cottonseed-derived products from the new variety are not materially different in composition, safety, and other relevant parameters from cottonseed and cottonseed-derived products currently on the market, and that genetically engineered cotton event GHB614 does not raise issues that would require premarket review or approval by FDA.

It is Bayer's responsibility to obtain all appropriate clearances, including those from the Environmental Protection Agency and the United States Department of Agriculture, before marketing food or feed derived from cotton event GHB614.

Based on the information Bayer has presented to FDA, we have no further questions concerning cottonseed and cottonseed-derived products from cotton event GHB614 at this time. However, as you are aware, it is Bayer's continued responsibility to ensure that foods marketed by the firm are safe, wholesome, and in compliance with all applicable legal and regulatory requirements.

Sincerely yours,

Laura M. Tarantino, Ph.D.
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition

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