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U.S. Department of Health and Human Services

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Biotechnology Consultation Agency Response Letter BNF No. 000137

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. 000137 for further details

CFSAN/Office of Food Additive Safety

May 7, 2013

Georges Freyssinet, CEO
Genective S.A.
1 rue Limagrain
BP1
63720 Chappes
FRANCE

Dear Dr. Freyssinet:

This letter addresses Genective S.A.’s (Genective’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 glyphosate-tolerant corn event VCO-Ø1981-5. According to information Genective has provided, corn event VCO-Ø1981-5 is genetically engineered to express a modified 5-enolpyruvylshikimate-3-phosphate synthase (EPSPS ACE5) protein. The EPSPS ACE5 protein confers tolerance to the herbicide glyphosate. All materials relevant to this notification have been placed in a file designated BNF 000137. This file will be maintained in the Office of Food Additive Safety in CFSAN.

As part of bringing this consultation to closure, Genective submitted a summary of its safety and nutritional assessment of genetically engineered corn event VCO-Ø1981-5 dated March 5, 2012. Genective submitted additional information on August 27, 2012. These communications informed FDA of the steps taken by Genective 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 Genective has conducted, it is our understanding that Genective has concluded that food and feed derived from corn event VCO-Ø1981-5 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 VCO-Ø1981-5 does not raise issues that would require premarket review or approval by FDA.

It is Genective’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 corn event VCO-Ø1981-5.

Based on the information Genective has presented to FDA, we have no further questions concerning food and feed derived from corn event VCO-Ø1981-5 at this time. However, as you are aware, it is Genective’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 000137, as well as a copy of the text of FDA’s memorandum summarizing the information in BNF 000137, 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