Biotechnology Consultation Agency Response Letter BNF No. 000107
Return to inventory: Completed Consultations on Foods from Genetically Engineered Plant Varieties
August 8, 2007
Natalia N. Bogdanova, D.V.M.
Regulatory Affairs Manager
800 North Lindbergh Blvd
St. Louis, MO 63167
Dear Dr. Bogdanova:
This is in regard to Monsanto Company’s consultation with the Food and Drug Administration (FDA) (Center for Food Safety and Applied Nutrition and Center for Veterinary Medicine) on its genetically engineered corn event MON 89034. According to Monsanto, corn event MON 89034 is genetically engineered to express the insect control proteins Cry1A.105 and Cry2Ab2, which provide protection from a broad spectrum of Lepidopteran insect pests. All materials relevant to this notification have been placed in a file designated BNF 107. 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 engineered corn on October 13, 2006. Monsanto provided additional clarifying information to FDA on January 18 and on March 8, 2007. These communications informed the 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 corn grain and forage derived from the new variety are not materially different in composition, safety, and other relevant parameters from corn grain and forage currently on the market and that genetically engineered corn event MON 89034 does not raise issues that would require premarket review or approval by FDA.
Because the Environmental Protection Agency (EPA) regulates pesticidal substances, FDA has not evaluated the information related to the safety of the Cry1A.105 and Cry2Ab2 proteins. It is Monsanto's responsibility to obtain all appropriate clearances, including those from the EPA and the United States Department of Agriculture, before marketing food or feed derived from corn event MON 89034.
Based on the information Monsanto has presented to FDA, we have no further questions concerning grain and forage derived from corn event MON 89034 at this time. However, as you are aware, it is Monsanto's continued responsibility to ensure that foods marketed by the firm are safe, wholesome, and in compliance with all applicable legal and regulatory requirements.
Laura M. Tarantino, Ph.D.
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition