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U.S. Department of Health and Human Services

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Biotechnology Consultation Agency Response Letter BNF No. 000120

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. 000120 for further details

CFSAN/Office of Food Additive Safety

April 13, 2011

Mr. Craig Blewett
Regulatory Leader
Dow AgroSciences LLC
9330 Zionsville Road
Indianapolis, IN 46268

 

Dear Mr. Blewett:

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 its genetically engineered corn, DAS-40278-9. According to Dow, DAS-40278-9 corn is engineered to confer tolerance to the herbicide 2,4-dichlorophenoxyacetic acid (or “2,4-D”) and certain aryloxyphenoxypropionate herbicides (e.g., quizalofop, cyhalofop, haloxyfop). The herbicide tolerance in DAS-40278-9 corn was achieved through expression of the aad-1 gene, which encodes the aryloxyalkanoate dioxygenase-1 (AAD-1) protein. All materials relevant to this notification have been placed in a file designated BNF 000120. This file will be maintained in the Office of Food Additive Safety.

As part of bringing this consultation to closure, Dow submitted a summary of its safety and nutritional assessment of the genetically modified corn on September 30, 2009. Dow provided additional information on January 14, March 18, and April 14, 2010. 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 DAS-40278-9 corn is not materially different in any respect relevant to food or feed safety from corn varieties currently on the market and that the genetically engineered corn 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-40278-9 corn.

Based on the information Dow has provided to FDA, we have no further questions concerning the new corn variety, DAS-40278-9 corn, 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 000120, as well as a copy of the text of FDA’s memorandum summarizing the information in BNF 000120, is available for public review and copying via the FDA Completed Consultations on Bioengineered Foods page at www.fda.gov/bioconinventory.

Sincerely,

Mitchell A. Cheeseman, Ph.D.
Acting Director
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition