Biotechnology Consultation Agency Response Letter BNF No. 000020
September 26, 1995
Dr. W. Martin Strauss
Agricultural Regulation Director
700 14th Street, NW
Washington, DC 20005
Dear Dr. Strauss:
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 canola line GT73 that is genetically modified to be tolerant to the herbicide glyphosate. The new canola variety has been rendered tolerant to the herbicide glyphosate by the expression of the 5-enolpyruvylshikimate-3-phosphate synthase (EPSPS) gene isolated from Agrobacterium sp. strain CP4 and a mutated version of the wild type glyphosate oxidoreductase (GOX) gene from Achromobacter sp. strain LBAA (GOX v247).
On March 6, 1995, Monsanto met with FDA to discuss their safety and nutritional assessment of canola line GT73. As part of bringing Monsanto's consultation with FDA regarding this product to closure, Monsanto submitted a summary assessment of new canola line GT73 on April 3, 1995. These communications informed FDA of the steps taken by Monsanto to ensure that this product complies with those 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 this new canola variety is not materially different in composition, safety, or any other relevant parameter from canola varieties currently on the market and that it does not raise issues that would require premarket review or approval by FDA. All materials relevant to this consultation have been placed in a file that has been designated BNF 0020 and that will be maintained in the Office of Premarket Approval.
Based on the information Monsanto has presented, we have no additional questions concerning this product at this time. However, as you are aware, it is Monsanto's continued responsibility to ensure that foods the firm markets 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