Biotechnology Consultation Agency Response Letter
BNF No. 000140
Return to inventory: Completed Consultations on Foods from Genetically Engineered Plant Varieties
CFSAN/Office of Food Additive Safety
February 7, 2014
Lei Han, Ph.D.
Dow AgroSciences LLC
9330 Zionsville Road
Indianapolis, IN 46268
Dear Dr. Han:
This letter addresses Dow AgroSciences LLC’s (Dow) consultation with the Food and Drug Administration (FDA) (Center for Food Safety and Applied Nutrition (CFSAN) and Center for Veterinary Medicine) on genetically engineered insect-resistant soybean, transformation event DAS-81419-2. According to information Dow has provided, DAS-81419-2 soybean is genetically engineered to express the Cry1F, Cry1Ac, and phosphinothricin N-acetyltransferase (PAT) proteins. Expression of the Cry1F and Cry1Ac proteins is intended to confer resistance to several lepidopteran pests of soybean. The PAT protein functions as a selectable marker and was used during DAS-81419-2 soybean development. All materials relevant to this consultation have been placed in a file designated BNF 000140. This file will be maintained in the Office of Food Additive Safety in CFSAN.
As part of bringing this consultation to closure, Dow submitted a summary of its safety and nutritional assessment of the genetically engineered soybean on October 15, 2012. Dow submitted additional information on February 28, 2013. 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-81419-2 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 DAS-81419-2 soybean does not raise issues that would require premarket review or approval by FDA.
The Environmental Protection Agency (EPA) regulates plant-incorporated protectants (PIPs), which include both the active and inert ingredients. DAS-81419-2 soybean contains PIPs, which are within the purview of EPA. It is Dow’s responsibility to obtain all appropriate clearances, including those from EPA and the United States Department of Agriculture, before marketing food or feed derived from DAS-81419-2 soybean.
Based on the information Dow has presented to FDA, we have no further questions concerning food and feed derived from DAS-81419-2 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 000140, as well as a copy of the text of FDA’s memorandum summarizing the information in BNF 000140, 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