Biotechnology Consultation Agency Response Letter BNF No. 000079
September 23, 2003
Terry B. Stone
Regulatory Affairs Manager
700 Chesterfield Parkway North
St. Louis, MO, 63198
Dear Mr. Stone:
This is in regard to the consultation of Monsanto Company (Monsanto) and The Scotts Company (Scotts) with the Food and Drug Administration (FDA) (Center for Veterinary Medicine and Center of Food Safety and Applied Nutrition) on their genetically engineered creeping bentgrass (Agrostis stolonifera) line ASR368. According to Monsanto and Scotts, this new line is engineered to express one new protein, a 5-enolpyruvylshikimate-3-phosphate synthase from Agrobacterium sp. CP4 strain (CP4 EPSPS). The CP4 EPSPS protein provides resistance to glyphosate herbicide. All materials relevant to this notification have been placed in a file designated BNF 0079. This file will be maintained in the Office of Food Additive Safety.
As part of bringing the consultation regarding this product to closure, Monsanto and Scotts submitted a summary of their safety and nutritional assessment of the genetically engineered creeping bentgrass on September 13, 2002. This communication informed the FDA of the steps taken by Monsanto and Scotts 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 and Scotts have conducted, it is our understanding that Monsanto and Scotts have concluded that glyphosate-tolerant creeping bentgrass forage derived from the new variety is not materially different in composition, safety, and other relevant parameters from creeping bentgrass forage currently on the market and that the genetically engineered creeping bentgrass does not raise issues that would require premarket review or approval by FDA.
It is Monsanto's and Scotts' responsibility to obtain all appropriate clearances, including those from the Environmental Protection Agency and the United States Department of Agriculture, before marketing feed derived from genetically engineered creeping bentgrass line ASR 368.
Based on the information Monsanto and Scotts have presented to FDA, we have no further questions concerning forage from glyphosate-tolerant creeping bentgrass line ASR368 at this time. However, as you are aware, it is the continued responsibility of Monsanto and Scotts 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