Biotechnology Consultation Agency Response Letter BNF No. 000126
Return to inventory: Completed Consultations on Foods from Genetically Engineered Plant Varieties
See FDA's memo on BNF No. 000126 for further details
CFSAN/Office of Food Additive Safety
April 13, 2012
Dr. Dennis P. Phillion
Regulatory Affairs Manager
800 North Lindbergh Boulevard
St. Louis, MO 63167
Dear Dr. Phillion:
This letter is in regard to Monsanto Company’s (Monsanto) consultation with the Food and Drug Administration (FDA) (Center for Food Safety and Applied Nutrition and Center for Veterinary Medicine) on genetically engineered corn, MON 87427. According to information Monsanto has provided, MON 87427 corn is genetically engineered to confer resistance to the herbicide glyphosate. The herbicide tolerance in MON 87427 corn was achieved through the expression of the cp4 epsps gene. Monsanto further states that the expression of CP4 EPSPS has been targeted to selected tissues to facilitate hybrid seed production. All materials relevant to this notification have been placed in a file designated BNF 000126. 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 corn on December 15, 2010. Monsanto submitted additional information on April 21, 2011, and April 28, 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 87427 corn are not materially different in composition, safety, and other relevant parameters from corn-derived food and feed currently on the market, and that genetically engineered MON 87427 corn 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 87427 corn.
Based on the information Monsanto has presented to FDA, we have no further questions concerning food and feed derived from MON 87427 corn 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 000126, as well as a copy of the text of FDA’s memorandum summarizing the information in BNF 000126, 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