Biotechnology Consultation Agency Response Letter BNF No. 000095
Return to inventory: Completed Consultations on Foods from Genetically Engineered Plant Varieties
CFSAN/Office of Food Additive Safety
August 7, 2007
Regulatory Affairs Manager
Syngenta Seeds, Inc.
P.O. Box 12257
3054 East Cornwallis Road
Research Triangle Park, North Carolina 27709-2257
Dear Ms. Tuttle:
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 its genetically engineered corn event 3272. According to Syngenta, this new event is engineered to express two new proteins, AMY797E alpha-amylase and phosphomannose isomerase (PMI). AMY797E alpha-amylase is used in the production of ethanol from corn grain. The PMI protein functions as a selectable marker. All materials relevant to this notification have been placed in a file designated BNF 0095. 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 corn dated August 31, 2005. Syngenta submitted additional information on May 1, 2006, August 2, 2006, November 8, 2006, January 19, 2007, March 2, 2007, March 6, 2007, March 7, 2007, May 31, 2007, July 11, 2007 and July 12, 2007. 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 grain and forage from the new variety are not materially different in composition, safety, and other relevant parameters from grain and forage currently on the market, and that genetically engineered corn event 3272 does not raise issues that would require premarket review or approval by FDA.
It is the responsibility of Syngenta 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 corn event 3272.
Based on the information Syngenta has presented to FDA, we have no further questions concerning grain and forage from corn event 3272 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.
Laura M. Tarantino, Ph.D.
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition