Biotechnology Consultation Agency Response Letter BNF No. 000018
July 24, 1996
Dr. Kent Croon
Regulatory Affairs Manager
700 Chesterfield Parkway North
Chesterfield, Missouri 63198
Dear Dr. Croon:
This is in regard to Monsanto's consultation with the Food and Drug Administration (FDA) (Center for Veterinary Medicine and Center for Food Safety and Applied Nutrition) on genetically modified corn, specifically transformation event MON801. According to Monsanto, this new corn variety has been modified for resistance to the European Corn Borer through expression of the cryIA(b) gene from Bacillus thuringiensis subsp. kurstaki.
On March 10, 1995, Monsanto met with FDA to discuss the proposed safety and nutritional assessment of corn containing transformation event MON801. As part of bringing the consultation regarding this product to closure, Monsanto submitted a summary assessment of corn containing transformation event MON801 on September 15, 1995.
These communications informed FDA of the steps taken by Monsanto to ensure that these products comply with the legal and regulatory requirements that fall within FDA's jurisdiction. Based on the safety and nutritional assessment you have conducted, it is our understanding that Monsanto has concluded that corn grain (kernels), fodder, and silage derived from the new variety are not materially different in composition, safety, and other relevant parameters from corn grain, fodder, and silage currently on the market, and that the genetically modified corn does not raise issues that would require premarket review or approval by FDA. All materials relevant to this notification have been placed in a file designated BNF0018. This file will be maintained in the Office of Premarket Approval.
Based on the information Monsanto has presented, we have no further questions concerning corn containing transformation event MON801 at this time. However, as you are aware, it is Monsanto's responsibility to ensure that foods marketed by the firm are safe, wholesome and in compliance with all applicable legal and regulatory requirements.
Alan M. Rulis, Ph.D.
Office of Premarket Approval
Center for Food Safety
and Applied Nutrition