Biotechnology Consultation Agency Response Letter BNF No. 000131
Return to inventory: Completed Consultations on Foods from Genetically Engineered Plant Varieties
CFSAN/Office of Food Additive Safety
December 24, 2013
Taiwo O. Koyejo, Ph.D.
800 North Lindbergh Boulevard
St. Louis, MO 63167
Dear Dr. Koyejo:
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 its genetically engineered soybean, MON 87712. According to information Monsanto has provided, MON 87712 soybean is genetically engineered to increase soybean yield. This intended effect is achieved through the introduction of a gene (BBX32), which encodes a protein that regulates the plant's diurnal processes during the reproductive phase of soybean development, providing an opportunity for increased soybean yield. All materials relevant to this notification have been placed in a file designated BNF 000131. This file will be maintained in the Office of Food Additive Safety in CFSAN.
As part of bringing the consultation regarding this product to closure, Monsanto submitted a summary of its safety and nutritional assessment of MON 87712 soybean on October 28, 2011. Monsanto submitted additional information on August 9, 2012. 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 87712 soybean are not materially different in safety, composition, or other relevant parameters from food and feed from soybean currently on the market, and that MON 87712 soybean 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 Environmental Protection Agency and the United States Department of Agriculture, before marketing food or feed derived from MON 87712 soybean.
Based on the information Monsanto has presented to FDA, we have no further questions concerning food and feed derived from MON 87712 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 000131, as well as a copy of the text of FDA’s memorandum summarizing the information in BNF 000131, is available for public review and copying at www.fda.gov/bioconinventory.
Dennis M. Keefe, Ph.D.
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition