Biotechnology Consultation Agency Response Letter BNF No. 000133
Return to inventory: Completed Consultations on Foods from Genetically Engineered Plant Varieties
CFSAN/Office of Food Additive Safety
December 16, 2013
Global Regulatory Leader
9330 Zionsville Road
Indianapolis, IN 46268
Dear Ms. Tagliani:
This letter is in regard to Dow AgroSciences' (Dow) consultation with the Food and Drug Administration (FDA) (Center for Veterinary Medicine and Center for Food Safety and Applied Nutrition (CFSAN)) on genetically engineered soybean, transformation event DAS-44406-6 soybean. According to information that Dow has provided, DAS-44406-6 soybean is genetically engineered to express the aryloxyalkanoate dioxygenase-12 (AAD-12) protein, the double mutant 5-enolpyruvylshikimate-3-phosphate synthase (2mEPSPS) protein, and the phosphinothricin N-acetyltransferase (PAT) protein. The AAD-12, 2mEPSPS, and PAT proteins render the soybean tolerant to the herbicides 2,4-dichlorophenoxyacetic acid, glyphosate, and glufosinate, respectively. All materials relevant to this notification have been placed in a file designated BNF 000133. This file will be maintained in the Office of Food Additive Safety in CFSAN.
As part of bringing the consultation to closure, Dow submitted a summary of its safety and nutritional assessment of the genetically engineered soybean on September 9, 2011. Dow submitted additional information on April 11 and August 6, 2012. These communications informed FDA of the steps taken by Dow 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 Dow has conducted, it is our understanding that Dow has concluded that food and feed derived from DAS-44406-6 soybean are not materially different in composition, safety, and other relevant parameters from soybean-derived food and feed currently on the market, and that the genetically engineered DAS-44406-6 soybean does not raise issues that would require premarket review or approval by FDA.
It is Dow’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 DAS-44406-6 soybean.
Based on the information Dow has presented to FDA, we have no further questions concerning food and feed derived from DAS-44406-6 soybean at this time. However, as you are aware, it is Dow’s continuing responsibility to ensure that foods marketed by the firm are safe, wholesome, and in compliance with all applicable legal and regulatory requirements. A copy of the text of this letter responding to BNF 000133, as well as a copy of the text of FDA’s memorandum summarizing the information in BNF 000133, is available for public review and copying via the FDA Completed Consultations on Bioengineered Foods page at www.fda.gov/bioconinventory.
Dennis M. Keefe, Ph.D.
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition