Food

Biotechnology Consultation Agency Response Letter BNF 000151

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. 000151 for further details

April 29, 2016

Sydney Jarrett
Syngenta Seeds, Inc.
P.O. Box 12257
3054 Cornwallis Road
Research Triangle Park, NC 27709

Dear Ms. Jarrett:

This letter addresses Syngenta Seeds, Inc.’s (Syngenta’s) consultation with the Food and Drug Administration (FDA) (Center for Food Safety and Applied Nutrition (CFSAN) and Center for Veterinary Medicine) on genetically engineered corn, MZIR098. According to information Syngenta has provided, MZIR098 corn is genetically engineered to express the insecticidal proteins eCry3.1Ab and mCry3A and to express the enzyme phosphinothricin acetyltransferase, which confers tolerance to the herbicide glufosinate ammonium. All materials relevant to this consultation have been placed in a file designated BNF 000151. This file will be maintained in the Office of Food Additive Safety in CFSAN.

As part of bringing this consultation to closure, Syngenta submitted to FDA a summary of its safety and nutritional assessment of the genetically engineered corn, which FDA received on July 1, 2015. Syngenta submitted additional information, received by FDA on October 23, 2015. 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 from MZIR098 corn 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 MZIR098 corn 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. MZIR098 corn contains PIPs, which are 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 MZIR098 corn.

Based on the information Syngenta has presented to FDA, we have no further questions concerning food and feed derived from MZIR098 corn 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 000151, as well as a copy of the text of FDA’s memorandum summarizing the information in BNF 000151, is available for public review and copying at http://www.fda.gov/bioconinventory.

Sincerely yours,

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

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