Biotechnology Consultation Agency Response Letter BNF No. 000084
December 10, 2004
Regulatory Affairs Manager
800 N. Lindbergh Blvd.
St. Louis, MO 63167
Dear Mr. Rogan:
This is in regard to the consultation that Monsanto Company (Monsanto) and Forage Genetics Incorporated (Forage Genetics) initiated with the Food and Drug Administration (FDA) (Center for Veterinary Medicine and Center for Food Safety and Applied Nutrition) on their genetically engineered alfalfa event J101 and event J163. According to Monsanto and Forage Genetics, these new events are both engineered to express the same 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 0084. This file will be maintained in the Office of Food Additive Safety.
As part of bringing the consultation regarding these products to closure, Monsanto and Forage Genetics jointly submitted a summary of their safety and nutritional assessment of the genetically engineered alfalfa varieties, dated October 6, 2003. Monsanto and Forage Genetics submitted additional information in a submission dated June 15, 2004. These communications informed the FDA of the steps taken by Monsanto and Forage Genetics 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 Monsanto and Forage Genetics have conducted, it is our understanding that Monsanto and Forage Genetics have concluded that food and feed derived from the new alfalfa varieties are not materially different in composition, safety, and other relevant parameters from food and feed derived from alfalfa varieties currently on the market, and that the genetically engineered alfalfa varieties do not raise issues that would require premarket review or approval by the FDA.
It is the responsibility of Monsanto and Forage Genetics 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 either alfalfa event J101 or event J163.
Based on the information Monsanto and Forage Genetics have presented to FDA, we have no further questions concerning food or feed derived from alfalfa event J101 or event J163 at this time. However, as you are aware, it is Monsanto's and Forage Genetics' 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