Biotechnology Consultation
Agency Response Letter
BNF No. 000086

Luann Powell
Bayer CropScience, USA LP
P.O. Box 12014
Research Triangle Park, NC 27709

Dear Ms. Powell:

This is in regard to Bayer CropScience, USA LP's (Bayer) consultation with the Food and Drug Administration (FDA) (Center for Veterinary Medicine and Center for Food Safety and Applied Nutrition) on its genetically engineered cotton, transformation event LLCotton25. According to Bayer, this new line, transformation event LLCotton25, is designed to express the phosphinothricin-N-acetyltransferase (PAT) protein. The PAT protein confers herbicide tolerance. All materials relevant to this notification have been placed in a file designated BNF 000086. 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, transformation event LLCotton25 on August 30, 2002. Bayer provided additional information in a submission dated January 8, 2003. These communications informed 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, refined oil, and toasted meal derived from the new variety, are not materially different in composition, safety, and other relevant parameters from cottonseed, refined oil, and toasted meal currently on the market and that the genetically engineered cotton 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 transformation event LLCotton25.

Based on the information Bayer has presented to FDA, we have no further questions concerning cottonseed, refined oil, and toasted meal derived from transformation event LLCotton25 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,    /s/ Alan M. Rulis, Ph.D. Director Office of Food Additive Safety Center for Food Safety     and Applied Nutrition