Food

Biotechnology Consultation Agency Response Letter BNF 000142

Return to inventory: Completed Consultations on Foods from Genetically Engineered 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. 000142 for further details

CFSAN/Office of Food Additive Safety

November 14, 2014

Gary Rudgers, Ph.D.
U.S. Regulatory Leader
Dow AgroSciences LLC
9330 Zionsville Road
Indianapolis, IN 46268

Dear Dr. Rudgers:

This letter addresses Dow AgroSciences LLC’s (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 cotton, transformation event DAS-81910-7. According to information that Dow has provided, DAS-81910-7 cotton is genetically engineered to express aryloxyalkanoate dioxygenase-12 (AAD-12) from Delftia acidovorans and phosphinothricin N-acetyltransferase (PAT) from Streptomyces viridochromogenes. Expression of the AAD-12 and PAT proteins is intended to confer resistance to the herbicides 2,4-dichlorophenoxyacetic acid and glufosinate, respectively. All materials relevant to this notification have been placed in a file designated BNF 000142. 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 cotton on June 26, 2013. Dow submitted additional information on November 25, 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-81910-7 cotton are not materially different in composition, safety, and other relevant parameters from cotton-derived food and feed currently on the market, and that the genetically engineered DAS-81910-7 cotton 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-81910-7 cotton.

Based on the information Dow has presented to FDA, we have no further questions concerning food and feed derived from DAS-81910-7 cotton 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 000142, as well as a copy of the text of FDA’s memorandum summarizing the information in BNF 000142, 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

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