Biotechnology Consultation
Agency Response Letter
BNF No. 000094

Lori Artim
Syngenta Seeds, Inc.
P.O. Box 12257
3054 Cornwallis Road
Research Triangle Park, NC 27709-2257

Dear Ms. Artim:

This is in regard to the consultation that Syngenta Seeds, Inc. (Syngenta) initiated with the Food and Drug Administration (FDA) (Center for Veterinary Medicine and Center for Food Safety and Applied Nutrition) on genetically engineered cotton line COT102. According to Syngenta, this new line is engineered to express two new proteins, vegetative insecticidal protein (VIP3A) and hygromycin B phosphotransferase (APH4). The VIP3A protein confers insect resistance. The APH4 protein (the selectable marker) confers the ability of transformed cells to grow in the presence of hygromycin. All materials relevant to this notification have been placed in a file designated BNF 0094. This file will be maintained in the Office of Food Additive Safety.

As part of bringing the consultation regarding this product to closure, Syngenta submitted a summary of its safety and nutritional assessment of the genetically engineered cotton on October 27, 2003. Syngenta submitted additional information on February 13, 2004, February 17, 2004, March 29, 2004, and July 26, 2004. These communications informed the FDA of the steps taken by Syngenta 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 Syngenta has conducted, it is our understanding that Syngenta has concluded that cottonseed and cottonseed-based products derived from the new variety are not materially different in composition, safety, and other relevant parameters, from cottonseed and cottonseed-based products currently on the market and that the genetically engineered cotton does not raise issues that would require premarket review or approval by FDA.

Because the Environmental Protection Agency (EPA) regulates pesticidal substances and pesticidal inert ingredients, FDA has not evaluated the information related to the safety of the VIP3A and APH4 proteins. It is Syngenta's responsibility to obtain all appropriate clearances, including those from the EPA and the United States Department of Agriculture, before marketing food or feed derived from cotton line COT102.

Based on the information Syngenta has presented to FDA, we have no further questions concerning cottonseed and cottonseed-based products derived from cotton line COT102 at this time. However, as you are aware, it is Syngenta'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/

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