Biotechnology Consultation Agency Response Letter BNF No. 000104
Return to inventory: Completed Consultations on Foods from Genetically Engineered Plant Varieties
CFSAN/Office of Food Additive Safety
January 19, 2007
Jianying J. Meyer, Ph.D., MBA
Regulatory Affairs Manager
800 North Lindbergh Blvd.
St. Louis, MO 63167
Dear Dr. Meyer:
This is in regard to Monsanto Company's (Monsanto) 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 89788. According to Monsanto, this new event is engineered to express one new protein, CP4 5-enolpyruvylshikimate-3-phosphate synthase (CP4 EPSPS). The CP4 EPSPS protein confers tolerance to glyphosate herbicide. All material relevant to this notification have been placed in a file designated BNF 00104. 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 on May 26, 2006, a summary of its safety and nutritional assessment of the genetically engineered soybean. This communication informed FDA of the steps taken by Monsanto to ensure that this product complies with all 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 the new soybean variety is not materially different in composition, safety, and other relevant parameters 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 the soybean MON 89788.
Based on the information Monsanto has presented to FDA, we have no further questions concerning the new soybean MON 89788 at this time. However, as you are aware, it is Monsanto's continued responsibility to ensure that foods marketed by firms 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