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U.S. Department of Health and Human Services

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Biotechnology Consultation Agency Response Letter BNF No. 000106

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. 000106 for further details

CFSAN/Office of Food Additive Safety

July 31, 2012

Robert Potter
Robert Potter Consulting
306-179 George Street
Ottawa, Ontario K1N 1J8
CANADA

Dear Mr. Potter:

This is in regard to Stine Seed Farm, Inc.'s (Stine) consultation with the Food and Drug Administration (FDA) (Center for Food Safety and Applied Nutrition (CFSAN) and Center for Veterinary Medicine) on genetically engineered maize (corn), HCEM485. According to information that you submitted on behalf of Stine, HCEM485 corn is genetically engineered to express a modified 5-enolpyruvylshikimate-3-phosphate synthase (2mEPSPS) protein. The 2mEPSPS protein is intended to confer tolerance to the herbicide glyphosate. All materials relevant to this notification have been placed in a file designated BNF 000106. This file will be maintained in the Office of Food Additive Safety in CFSAN.

As part of bringing this consultation to closure, you submitted a summary of the safety and nutritional assessment of the genetically engineered corn on December 9, 2010. You submitted additional information on October 6 and 17, 2011, and January 10, 2012. These communications informed FDA of the steps taken by Stine 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 Stine has conducted, it is our understanding that Stine has concluded that food and feed derived from HCEM485 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 HCEM485 corn does not raise issues that would require premarket review or approval by FDA.

It is Stine’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 HCEM485 corn.

Based on the information you have presented to FDA on Stine's behalf, we have no further questions concerning food and feed derived from HCEM485 corn at this time. However, as you are aware, it is Stine’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 000106, as well as a copy of the text of FDA’s memorandum summarizing the information in BNF 000106, is available for public review and copying via the FDA Completed Consultations on Bioengineered Foods page at www.fda.gov/bioconinventory.

Sincerely yours,

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