Biotechnology Consultation Agency Response Letter BNF No. 000122
Return to inventory: Completed Consultations on Foods from Genetically Engineered Plant Varieties
See FDA's memo on BNF No. 000122 for further details
CFSAN/Office of Food Additive Safety
August 7, 2012
Dr. Isabelle S. Coats
U.S. Registration Manager
Bayer CropScience LP
2 T.W. Alexander Drive
Research Triangle Park, NC 27709
Dear Dr. Coats:
This letter is in regard to the consultation of Bayer CropScience LP (Bayer) and M.S. Technologies LLC (M.S.) with the Food and Drug Administration (FDA) (Center for Food Safety and Applied Nutrition and Center for Veterinary Medicine) on genetically engineered soybean event FG72 (FG72 soybean). According to information Bayer and M.S. have provided, FG72 soybean is genetically engineered to confer resistance to the herbicides glyphosate and p-hydroxyphenylpyruvate dioxygenase inhibitors, such as isoxaflutole. The herbicide tolerance in FG72 soybean was achieved through the expression of the 2mepsps and hppdPfW336 genes. All materials relevant to this notification have been placed in a file designated BNF 000122. This file will be maintained in the Office of Food Additive Safety.
As part of bringing this consultation to closure, Bayer and M.S. submitted a summary of their safety and nutritional assessment of the genetically engineered soybean on December 3, 2009. Bayer and M.S. submitted additional information on September 13, 2011, and May 3, 2012. These communications informed FDA of the steps taken by Bayer and M.S. 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 and M.S. have conducted, it is our understanding that Bayer and M.S. have concluded that food and feed derived from soybean event FG72 are not materially different in composition, safety, and other relevant parameters from soybean-derived food and feed currently on the market, and that genetically engineered soybean event FG72 does not raise issues that would require premarket review or approval by FDA.
It is the responsibility of Bayer and M.S. 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 FG72 soybean.
Based on the information Bayer and M.S. have presented to FDA, we have no further questions concerning food and feed derived from FG72 soybean at this time. However, as you are aware, it is the continuing responsibility of Bayer and M.S. to ensure that foods marketed by the firms are safe, wholesome, and in compliance with all applicable legal and regulatory requirements. A copy of the text of this letter responding to BNF 000122, as well as a copy of the text of FDA’s memorandum summarizing the information in BNF 000122, is available for public review and copying at www.fda.gov/bioconinventory.
Dennis M. Keefe, Ph.D.
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition