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U.S. Department of Health and Human Services

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Biotechnology Consultation Agency Response Letter BNF No. 000112

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. 000112 for further details

CFSAN/Office of Food Additive Safety

February 13, 2009

Scott A. Huber
Regulatory Affairs Manager
Syngenta Biotechnology, Inc.
P.O. Box 12257
3054 East Cornwallis Road
Research Triangle Park, NC 27709

Dear Mr. Huber:

This is in regard to Syngenta Seeds, Inc.’s (Syngenta) consultation with the Food and Drug Administration (FDA) (Center for Food Safety and Applied Nutrition and Center for Veterinary Medicine) on genetically engineered cotton event COT67B. According to information Syngenta has provided, cotton event COT67B is genetically engineered to express the FLCry1Ab protein. The protein is intended to confer resistance to a number of Lepidopteran insects. All materials relevant to this notification have been placed in a file designated BNF 0112. This file will be maintained in the Office of Food Additive Safety.

As part of bringing the consultation regarding this product to closure, Syngenta submitted a summary of its safety and nutritional assessment of the genetically engineered cotton on July 3, 2007. Syngenta submitted additional information dated December 13, 2007, and December 8, 2008. These communications informed the FDA of the steps taken by Syngenta 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 Syngenta has conducted, it is our understanding that Syngenta has concluded that food and feed derived from cotton event COT67B are not materially different in composition, safety, and other relevant parameters from cotton-derived food and feed currently on the market and that genetically engineered cotton event COT67B does not raise issues that would require premarket review or approval by FDA.

The Environmental Protection Agency (EPA) regulates plant-incorporated protectants (PIP), which include both the active and inert ingredients. EPA considers the recombinant DNA constructs used in the development of cotton event COT67B to be part of the PIP in cotton event COT67B, and therefore EPA is reviewing the information related to the safety of the recombinant DNA constructs and resulting expression products. It is Syngenta’s responsibility to obtain all appropriate clearances, including those from the EPA and the United States Department of Agriculture, before marketing food or feed derived from cotton event COT67B.

Based on the information Syngenta has presented to FDA, we have no further questions concerning food and feed derived from cotton event COT67B at this time. However, as you are aware, it is Syngenta’s continued responsibility to ensure that foods marketed by the firm are safe, wholesome, and in compliance with all applicable legal and regulatory requirements.

Sincerely yours,

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