Biotechnology Consultation Agency Response Letter BNF No. 000075
February 12, 2002
Dennis P. Ward, Ph.D.
800 North Lindbergh Boulevard
St. Louis, Missouri 63167
Dear Dr. Ward:
In a letter dated December 31, 2001, the Food and Drug Administration (FDA) responded to Monsanto’s consultation with the FDA (Center for Veterinary Medicine and Center of Food Safety and Applied Nutrition) on its genetically modified corn, line MON 863. In our letter, we inadvertently reported the name of the expressed protein in the MON 863 corn as Cry3Bb rather than Cry3Bb1. This was a trivial typographical error. We are issuing this second letter solely to clarify that the protein expressed in the MON 863 corn line is a modified Cry3Bb1. This letter repeats the text of our letter dated December 31, 2001, with the exception of correcting the name of the expressed protein from Cry3Bb to Cry3Bb1. We apologize for any inconvenience or confusion that may have resulted from our mistake.
According to Monsanto, this new line, MON 863, has been modified to express two new proteins, a modified Cry3Bb1 and NptII. The modified Cry3Bb1 protein confers resistance to Coleopteran insects, including corn rootworm. The NptII protein confers resistance to aminoglycoside antibiotics and was used as a selectable marker in the development of the MON 863 corn line. All materials relevant to this notification have been placed in a file designated BNF 0075. 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 modified corn on September 25, 2000. This communication 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 the corn derived from these new varieties is not materially different in composition, safety, and other relevant parameters from corn currently on the market and that the genetically modified corn does not raise issues that would require premarket review or approval by FDA.
Because the Environmental Protection Agency (EPA) regulates pesticidal substances and pesticidal inert ingredients, FDA has not evaluated the information related to the safety of the modified Cry3Bb1 and NptII proteins. It is Monsanto’s responsibility to obtain all appropriate clearances, including those from EPA and the United States Department of Agriculture, before marketing food or feed derived from corn line MON 863.
Based on the information Monsanto has presented to FDA, we have no further questions concerning corn from line MON 863 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.
Alan M. Rulis, Ph.D.
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition