Food

Biotechnology Consultation Agency Response Letter BNF 000144

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.000144 for further details

May 27, 2015

Debbie A. Mahadeo
Monsanto Company
800 N. Lindbergh Blvd.
St. Louis, MO 63167

Dear Ms. Mahadeo:

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 soybean, MON 87751. According to information Monsanto has provided, MON 87751 soybean is genetically engineered to express the Bacillus thuringiensis Cry1A.105 and Cry2Ab2 proteins to protect against lepidopteran insect pests. All materials relevant to this consultation have been placed in a file designated BNF 000144. This file will be maintained in the Office of Food Additive Safety in CFSAN.

As part of bringing this consultation to closure, Monsanto submitted to FDA a summary of its safety and nutritional assessment of the genetically engineered soybean, which FDA received on November 27, 2013. Monsanto submitted additional information, received by FDA on April 11, 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 from MON 87751 soybean are not materially different in composition, safety, and other relevant parameters from soybean-derived food and feed currently on the market, and that genetically engineered MON 87751 soybean does not raise issues that would require premarket review or approval by FDA.

The Environmental Protection Agency (EPA) regulates plant-incorporated protectants (PIP), which include both the active and inert ingredients. MON 87751 soybean contains PIPs, which are within the purview of EPA. It is Monsanto’s responsibility to obtain all appropriate clearances, including those from the EPA and the United States Department of Agriculture, before marketing food or feed derived from MON 87751 soybean.

Based on the information Monsanto has presented to FDA, we have no further questions concerning food and feed derived from MON 87751 soybean 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 000144, as well as a copy of the text of FDA’s memorandum summarizing the information in BNF 000144, 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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