Biotechnology Consultation Agency Response Letter BNF No. 000127
CFSAN/Office of Food Additive Safety
April 23, 2012
Ms. Margaret A. Wideman
Regulatory Affairs Manager
800 North Lindbergh Boulevard
St. Louis, MO 63167
Dear Ms. Wideman:
This letter is in regard to Monsanto’s consultation with the Food and Drug Administration (FDA) (Center for Food Safety and Applied Nutrition and Center for Veterinary Medicine) on genetically engineered canola, MON 88302. According to information Monsanto has provided, MON 88302 canola is genetically engineered to confer resistance to the herbicide glyphosate. The herbicide tolerance in MON 88302 was achieved through the expression of the cp4 epsps gene. All materials relevant to this notification have been placed in a file designated BNF 000127. 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 engineered canola on March 23, 2011. Monsanto submitted additional information on June 14, 2011, and September 16, 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 food and feed derived from MON 88302 canola are not materially different in composition, safety, and other relevant parameters from canola-derived food and feed currently on the market, and that genetically engineered MON 88302 canola 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 88302 canola.
Based on the information Monsanto has presented to FDA, we have no further questions concerning food and feed derived from MON 88302 canola 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 000127, as well as a copy of the text of FDA’s memorandum summarizing the information in BNF 000127, is available for public review and copying via the FDA Completed Consultations on Bioengineered Foods page at www.fda.gov/bioconinventory.
Dennis Keefe, Ph.D.
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition