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U.S. Department of Health and Human Services


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Biotechnology Consultation Agency Response Letter BNF No. 000099

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. 000099 for further details

CFSAN/Office of Food Additive Safety

January 30, 2007


Henry-York Steiner, Ph.D.
Syngenta Seeds, Inc.
PO Box 12257
3054 East Cornwallis Road
Research Triangle Park
NC 277709-2257

Dear Dr. Steiner:

This is in regard to Syngenta Seeds, Inc. (Syngenta) consultation with the Food and Drug Administration (FDA) (Center for Food Safety and Applied Nutrition and Center for Veterinary Medicine) on their genetically engineered corn event MIR604. According to Syngenta, corn event MIR604 is genetically engineered to express a modified insect control protein Cry3A, which provides protection from larval corn root worm damage. The phosphomannose isomerase (pmi) gene was used as a selectable marker. All materials relevant to this notification have been placed in a file designated BNF 0099. 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 their safety and nutritional assessment of the genetically engineered corn on February 23, 2005. Syngenta provided additional clarifying information to FDA on May 14, October 5, December 5, 2005, and February 10, March 21, June 16, July 10, July 17, July 19, and July 28, 2006. 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 corn grain and forage derived from the new variety are not materially different in composition, safety, and other relevant parameters from corn grain and forage currently on the market and that genetically engineered corn event MIR604 does not raise issues that would require premarket review or approval by FDA.

Because the Environmental Protection Agency (EPA) regulates pesticidal substances and pesticidal inert ingredients, FDA has not evaluated the information related to the safety of the modified Cry3A and PMI proteins. 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 corn event MIR604.

Based on the information Syngenta has presented to FDA, we have no further questions concerning grain and forage derived from corn event MIR604 at this time. However, as you are aware, it is Syngenta's continued responsibility to ensure that foods marketed by the firms are safe, wholesome, and in compliance with all applicable legal and regulatory requirements.

Sincerely yours,

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