Biotechnology Consultation Agency Response Letter BNF No. 000098
Return to inventory: Completed Consultations on Foods from Genetically Engineered Plant Varieties
March 7, 2005
J. Austin Burns
Regulatory Affairs Manager
800 N. Lindbergh Blvd.
St. Louis, MO 63167
Dear Dr. Burns:
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 cotton MON 88913. 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 materials relevant to this notification have been placed in a file designated BNF 0098. 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 27, 2004, a summary of its safety and nutritional assessment of the genetically engineered cotton. Monsanto provided additional information in submissions dated November 8, and December 10, 2004. 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 cottonseed, cottonseed meal and cottonseed oil from the new variety are not materially different in composition, safety, and other relevant parameters from cottonseed, cottonseed meal and cottonseed oil currently on the market, and that the genetically engineered 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 cotton MON 88913.
Based on the information Monsanto has presented to FDA, we have no further questions concerning cottonseed, cottonseed meal and cottonseed oil from cotton MON 88913 at this time. However, as you are aware, it is Monsanto's continued responsibility to ensure that foods marketed by the 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