Biotechnology Consultation Agency Response Letter BNF No. 000128

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. 000128 for further details

CFSAN/Office of Food Additive Safety

February 29, 2012

Ms. Demetra Vlachos, M.S.
Senior Regulatory Affairs Manager
Syngenta Seeds, Inc.
P.O. Box 12257
3054 East Cornwallis Road
Research Triangle Park, NC 27709-2257

Dear Ms. Vlachos:

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 its genetically engineered corn event 5307. According to information Syngenta has provided, corn event 5307 is genetically engineered to express the eCry3.1Ab protein and the phosphomannose isomerase (PMI) protein. The eCry3.1Ab protein confers resistance to certain Coleopteran insect pests of corn, and the PMI protein functions as a selectable marker. All materials relevant to this notification have been placed in a file designated BNF 000128. 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 corn on January 27, 2011. Syngenta submitted additional information on April 15, 2011. These communications informed 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 corn event 5307 are not materially different in composition, safety, and other relevant parameters from corn-derived food and feed currently on the market, and that genetically engineered corn event 5307 does not raise issues that would require premarket review or approval by FDA.

The Environmental Protection Agency (EPA) regulates plant-incorporated protectants (PIPs), which include both the active and inert ingredients. Corn event 5307 contains a PIP, which is within the purview of EPA. It is Syngenta’s responsibility to obtain all appropriate clearances, including those from EPA and the United States Department of Agriculture, before marketing food or feed derived from corn event 5307.

Based on the information Syngenta has presented to FDA, we have no further questions concerning food and feed derived from corn event 5307 at this time. However, as you are aware, it is Syngenta’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 000128, as well as a copy of the text of FDA’s memorandum summarizing the information in BNF 000128, is available for public review and copying via the FDA Completed Consultations on Bioengineered Foods page at

Sincerely yours,

Dennis Keefe, Ph.D.
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition

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