Biotechnology Consultation Agency Response Letter BNF No. 000135
Return to inventory: Completed Consultations on Foods from Genetically Engineered Plant Varieties
CFSAN/Office of Food Additive Safety
April 24, 2013
Ms. Marianne Malven
800 North Lindbergh Blvd.
St. Louis, MO 63167
Dear Ms. Malvern:
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 cotton, MON 88701. According to information Monsanto has provided, MON 88701 cotton is genetically engineered to confer tolerance to the herbicides dicamba and glufosinate ammonium. The herbicide tolerance to dicamba was achieved through the expression of a dmo gene encoding dicamba monooxygenase and the herbicide tolerance to glufosinate was achieved through the expression of a bar gene encoding phosphinothrycin N-acetyltransferase. All materials relevant to this notification have been placed in a file designated BNF 000135. 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 genetically engineered MON 88701 cotton on April 6, 2012. Monsanto submitted additional information on May 22, July 18, and September 10, 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 derived MON 88701 cotton are not materially different in composition, safety, and other relevant parameters from cottonseed-derived food and feed currently on the market, and that genetically engineered MON 88701 cotton 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 88701 cotton.
Based on the information Monsanto has presented to FDA, we have no further questions concerning food and feed derived from MON 88701 cotton 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 000135, as well as a copy of the text of FDA's memorandum summarizing the information in BNF 000135, is available for public review and copying at http://www.fda.gov/bioconinventory.
Dennis M. Keefe, Ph.D.
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition