Food

Biotechnology Consultation Agency Response Letter BNF 000145

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. 000145 for further details

October 17, 2014

John M. Cordts, M.S., M.B.A.
Monsanto Company
800 North Lindbergh Blvd
St. Louis, MO 63167

Dear Mr. Cordts,

This letter addresses Monsanto Company’s (Monsanto) 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, MON 87411. According to information Monsanto has provided, MON 87411 corn is genetically engineered to express: (1) double stranded RNA with the partial sequence of the Snf7 transcript from the western corn rootworm; (2) the Bacillus thuringiensis cry3Bb1 gene to protect against corn rootworm; and (3) the cp4 epsps gene to confer tolerance to the herbicide glyphosate. All materials relevant to this notification have been placed in a file designated BNF 000145. This file will be maintained in the Office of Food Additive Safety in CFSAN.

As part of bringing this consultation to closure, Monsanto submitted a summary of its safety and nutritional assessment of MON 87411 corn on November 15, 2013. Monsanto submitted additional information on March 14, 2014. These communications informed FDA of the steps taken by Monsanto 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 Monsanto has conducted, it is our understanding that Monsanto has concluded that food and feed derived from MON 87411 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 MON 87411 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. MON 87411 corn contains PIPs, which are within the purview of EPA. It is Monsanto’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 MON 87411 corn.

Based on the information Monsanto has presented to FDA, we have no further questions concerning food and feed derived from MON 87411 corn at this time. However, as you are aware, it is Monsanto’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 000145, as well as a copy of the text of FDA’s memorandum summarizing the information in BNF 000145, 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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