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U.S. Department of Health and Human Services

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Biotechnology Consultation Agency Response Letter BNF No. 000124

Return to inventory: Submissions on Bioengineered New Plant Varieties

See also Biotechnology: Genetically Engineered Plants for Food and Feed and about Submissions on Bioengineered New Plant Varieties


See FDA's memo on BNF No. 000124 for further details

CFSAN/Office of Food Additive Safety

Laura Tagliani
Global Regulatory Leader
Dow AgroSciences LLC
9330 Zionsville Road
Indianapolis, IN 46268

November 14, 2011

Dear Ms. Tagliani:

This is in regard to Dow AgroSciences LLC's (Dow's) consultation with the Food and Drug Administration (FDA) (Center for Veterinary Medicine and Center for Food Safety and Applied Nutrition) on genetically engineered soybean, DAS-68416-4 soybean. According to information Dow has provided, DAS-68416-4 soybean is engineered to express the aryloxyalkanoate dioxygenase-12 (AAD-12) protein, and the phosphinothricin N-acetyl transferase (PAT) protein. The AAD-12 and PAT proteins confer tolerance to the herbicides 2,4-dichlorophenoxyacetic acid (2,4-D) and glufosinate, respectively. All materials relevant to this notification have been placed in a file designated BNF 000124. This file will be maintained in the Office of Food Additive Safety in the Center for Food Safety and Applied Nutrition.

As part of bringing the consultation regarding this product to closure, Dow submitted a summary of its safety and nutritional assessment of the genetically engineered soybean on December 22, 2009. Dow submitted additional information on April 15, 2010, and on August 23 and 24, 2011. 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-68416-4 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-68416-4 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-68416-4 soybean.

Based on the information Dow has presented to FDA, we have no further questions concerning food and feed derived from DAS-68416-4 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 000124, as well as a copy of the text of FDA's memorandum summarizing the information in BNF 000124, is available for public review and copying via the FDA Completed Consultations on Bioengineered Foods page at www.fda.gov/bioconinventory.

Sincerely,

Dennis M. Keefe, Ph.D.
Director
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition