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U.S. Department of Health and Human Services

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Biotechnology Consultation Agency Response Letter BNF No. 000116

Return to inventory: Submissions on Bioengineered New 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. 000116 for further details

CFSAN/Office of Food Additive Safety

December 10, 2010

Dr. William R. Reeves
Regulatory Affairs Manager
Monsanto Company
800 North Lindbergh Boulevard
Saint Louis, Missouri 63167

Dear Dr. Reeves:

This is in regard to Monsanto’s consultation with the Food and Drug Administration (FDA) (Center for Veterinary Medicine and Center for Food Safety and Applied Nutrition) on its genetically engineered corn, MON 87460. According to Monsanto, corn line MON 87460 is engineered to express the Bacillus subtilis cold shock protein B protein. This protein is intended to reduce yield loss under water-limited conditions. This corn is also engineered to express neomycin phosphotransferase II, a selectable marker for transformation. All materials relevant to this notification have been placed in a file designated BNF 000116. This file will be maintained in the Office of Food Additive Safety.

As part of bringing this consultation to closure, Monsanto submitted a summary of its safety and nutritional assessment of the genetically modified corn on December 19, 2008. Monsanto provided additional information on April 9, 2009, May 1, 2009, June 1, 2009, June 29, 2009, July 7, 2009, August 10, 2009, September 10, 2009, November 2, 2009, and August 3, 2010. 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 corn MON 87460 is not materially different in any respect relevant to food or feed safety compared to corn varieties currently on the market and that the genetically engineered corn does not raise issues that would require premarket review or approval by FDA.

It is Monsanto’s responsibility to obtain all appropriate clearances, including those from the United States Department of Agriculture, before marketing food or feed derived from corn MON 87460.

Based on the information Monsanto has provided to FDA, we have no further questions concerning the new corn variety, corn MON 87460, 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 000116, as well as a copy of the text of FDA's memorandum summarizing the information in BNF 000116, is available for public review and copying via the FDA Completed Consultations on Bioengineered Foods page at www.fda.gov/bioconinventory.

Sincerely yours,

Mitchell A. Cheeseman, Ph.D.
Acting Director
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition