Biotechnology Consultation Agency Response Letter BNF No. 000113

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. 000113 for further details

CFSAN/Office of Food Additive Safety

December 9, 2008


Scott A. Huber
Syngenta Seeds, Inc.
P.O. Box 12257
3054 East Cornwallis Road
Research Triangle Park, NC 27709-2257

Dear Mr. Huber:

This is in regard to Syngenta Seeds, Inc.'s (Syngenta) consultation with the Food and Drug Administration (FDA) (Center for Veterinary Medicine and Center for Food Safety and Applied Nutrition) on its genetically engineered maize event MIR162. According to Syngenta, this new event is engineered to express two new proteins, Vip3Aa20 and phosphomannose isomerase (PMI). The Vip3Aa20 protein confers resistance to lepidopteran insect pests of maize and the PMI protein functions as a selectable marker. All materials relevant to this notification have been placed in a file designated BNF 0113. 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 maize dated August 3, 2007. Syngenta submitted additional information on December 17, 2007 and March 31, 2008. These communications informed the FDA of the steps taken by Syngenta to ensure that this product complies with all 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 maize forage and grain from the new variety are not materially different in composition, safety, and other relevant parameters from maize forage and grain currently on the market and that the genetically engineered maize event MIR162 does not raise issues that would require premarket review or approval by FDA.

The Environmental Protection Agency (EPA) regulates plant-incorporated protectants, which include both the active and inert ingredients. EPA considers the recombinant DNA construct containing the vip3Aa20 and pmi genes to be part of the plant-incorporated protectant in maize event MIR162, and therefore EPA is reviewing the information related to the safety of the recombinant DNA construct and resulting expression products. It is the responsibility of Syngenta to obtain all appropriate clearances, including those from the EPA and the United States Department of Agriculture, before marketing food derived from maize event MIR162.

Based on the information Syngenta has presented to FDA, we have no further questions concerning forage and grain from maize event MIR162 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.
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition

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