Food

Biotechnology Consultation Agency Response Letter BNF 000150

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. 000150 for further details

February 23, 2016

Sydney G. Jarrett, M.S.
U.S. Regulatory Affairs Specialist
Syngenta Seeds, Inc.
P.O. Box 12257
3054 E. Cornwallis Road
Research Triangle Park, NC 27709

Dear Ms. Jarrett:

This letter addresses Syngenta Seeds, Inc.’s (Syngenta) 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, event MZHG0JG. According to information Syngenta has provided, MZHG0JG corn is genetically engineered to express a modified 5-enol pyruvylshikimate-3-phosphate synthase (mEPSPS) from Zea mays, and phosphinothricin N-acetyltransferase (PAT) from Streptomyces viridochromogenes. Expression of the mEPSPS and PAT proteins is intended to confer resistance to the herbicides glyphosate and glufosinate-ammonium, respectively. All materials relevant to this consultation have been placed in a file designated BNF 000150. This file will be maintained in the Office of Food Additive Safety in CFSAN.

As part of bringing this consultation to closure, Syngenta submitted a summary of its safety and nutritional assessment of the genetically engineered corn, which FDA received on March 26, 2015. Syngenta submitted additional information, which we received on September 24, 2015. These communications informed FDA of the steps taken by Syngenta to ensure that food and feed from MZHG0JG corn comply 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 MZHG0JG 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 MZHG0JG corn does not raise issues that would require premarket review or approval by FDA.

It is Syngenta’s responsibility to obtain all appropriate clearances, including those from the Environmental Protection Agency and the United States Department of Agriculture, before marketing food or feed derived from MZHG0JG corn.

Based on the information Syngenta has presented to FDA, we have no further questions concerning food and feed derived MZHG0JG 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 000150, as well as a copy of the text of FDA’s memorandum summarizing the information in BNF 000150, 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

Page Last Updated: 03/10/2016
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