Biotechnology Consultation Agency Response Letter BNF No. 000139
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CFSAN/Office of Food Additive Safety
March 28, 2014
Dennis Ward, Ph.D.
Syngenta Seeds, Inc.
P.O. Box 12257
3054 East Cornwallis Road
Research Triangle Park, NC 27709
Dear Dr. Ward:
This letter addresses Syngenta Seeds, Inc. (Syngenta) and Bayer CropScience AG’s (BCS) consultation with the Food and Drug Administration (FDA) (Center for Food Safety and Applied Nutrition (CFSAN) and Center for Veterinary Medicine) on genetically engineered herbicide-tolerant soybean, transformation event SYHT0H2. According to information Syngenta and BCS (the developers) have provided, SYHT0H2 soybean is genetically engineered to express a p-hydroxyphenylpyruvate dioxygenase (HPPD) derived from common oat (AvHPPD-03) and phosphinothricin N-acetyltransferase from Streptomyces viridochromogenes (PAT). Expression of the AvHPPD-03 and PAT proteins is intended to confer tolerance to herbicides (such as mesotrione) that inhibit HPPD and to glufosinate ammonium, respectively. All materials relevant to this consultation have been placed in a file designated BNF 000139. This file will be maintained in the Office of Food Additive Safety in CFSAN.
As part of bringing this consultation to closure, Syngenta and BCS submitted a summary of their safety and nutritional assessment of the genetically engineered soybean on August 28, 2012. Syngenta and BCS submitted additional information on February 25, 2013. These communications informed FDA of the steps taken by Syngenta and BCS 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 and BCS have conducted, it is our understanding that the developers concluded that food and feed derived from SYHT0H2 soybean 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 SYHT0H2 soybean does not raise issues that would require premarket review or approval by FDA.
It is Syngenta and BCS’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 SYHT0H2 soybean.
Based on the information Syngenta and BCS have presented to FDA, we have no further questions concerning food and feed derived from SYHT0H2 soybean at this time. However, as you are aware, it is Syngenta’s and BCS’s continuing responsibility 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 000139, as well as a copy of the text of FDA’s memorandum summarizing the information in BNF 000139, is available for public review and copying at http://www.fda.gov/bioconinventory.
Dennis M. Keefe, Ph.D.
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition