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U.S. Department of Health and Human Services


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Biotechnology Consultation Agency Response Letter BNF No. 000077

Return to inventory: Completed Consultations on Foods from Genetically Engineered Plant Varieties

See also Biotechnology: Genetically Engineered Plants for Food and Feed and about Submissions on Bioengineered New Plant Varieties

See FDA's memo on BNF No. 000077 for further details

September 5, 2002

Dr. Russ Schneider
Monsanto Company
600 13th Street, N.W.
Suite 660
Washington, DC 20005

Dear Dr. Schneider:

This is in regard to Monsanto Company's (Monsanto) consultation with the Food and Drug Administration (FDA) (Center for Veterinary Medicine and Center of Food Safety and Applied Nutrition) on its genetically engineered canola line, GT200. Although Monsanto states that it has no intention of commercializing canola line GT200, Monsanto has initiated the consultation process because of its determination that line GT200 has the potential to be present at low, adventitious levels in commercial canola varieties. According to Monsanto, this new line is engineered to express two new proteins, CP4 5-enolpyruvylshikimate-3-phosphate synthase (CP4 EPSPS) and glyphosate oxidoreductase (GOX). The CP4 EPSPS and GOX proteins provide tolerance to glyphosate herbicide. All materials relevant to this notification have been placed in a file designated BNF 0077 and have been evaluated under our standard consultation procedures. 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 engineered canola on April 30, 2001, and submitted additional information on July 6 and October 1, 2001. These communications 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 canola seeds and canola-based products derived from the new variety are not materially different in composition, safety, and other relevant parameters from canola seeds and canola-based products currently on the market and that the genetically engineered canola does not raise issues that would require premarket review or approval by FDA.

It is Monsanto's responsibility 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 canola line GT200.

Based on the information Monsanto has presented to FDA, we have no further questions concerning canola seeds and canola-based products derived from canola line GT200 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.

Sincerely yours,

Alan M. Rulis,Ph.D.
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition