Biotechnology Consultation Agency Response Letter BNF No. 000125
Return to inventory: Submissions on Bioengineered New Plant Varieties
CFSAN/Office of Food Additive Safety
Ms. Rhonda M. Mannion
Regulatory Affairs Manager
800 North Lindbergh Boulevard
Saint Louis, Missouri 63167
October 11, 2011
Dear Ms. Mannion:
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 soybean, MON 87708. According to Monsanto, MON 87708 soybean is engineered to confer tolerance to the herbicide dicamba (3,6-dichloro-2-methoxybenzoic acid). The herbicide tolerance in MON 87708 soybean was achieved through the expression of the dmo gene, which encodes a dicamba mono-oxygenase (DMO) protein. All materials relevant to this notification have been placed in a file designated BNF 000125. This file will be maintained in the Office of Food Additive Safety.
As part of bringing the consultation regarding this product to closure, Monsanto submitted a summary of its safety and nutritional assessment of the genetically modified soybean on November 9, 2010. Monsanto provided additional information on February 25, 2011. 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 MON 87708 soybean is not materially different in any respect relevant to food or feed safety from soybean varieties currently on the market and that the genetically engineered 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 87708 soybean.
Based on the information Monsanto has presented to FDA, we have no further questions concerning the new soybean variety, MON 87708 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 000125, as well as a copy of the text of FDA’s memorandum summarizing the information in BNF 000125, is available for public review and copying via the FDA Completed Consultations on Bioengineered Foods page at www.fda.gov/bioconinventory.
Mitchell A. Cheeseman, Ph.D.
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition