U. S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
Office of Premarket Approval^*
November 3, 1998

Dear Drs. Dobert and Stein:

This letter is in regard to your genetically modified sugar beet, line 77, about which you initiated a consultation with the Agency in June of 1998. According to Monsanto and Novartis, this new sugar beet variety has been rendered tolerant to the non-selective herbicide glyphosate through the expression of the 5-enolpyruvylshikimate-3-phosphate synthase gene derived from Agrobacterium sp. strain CP4 (CP4 EPSPS).

You submitted a summary of your safety and nutritional assessment of the new sugar beet variety on June 5, 1998. This communication informed FDA of the steps taken by Monsanto and Novartis 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 and Novartis have concluded that the new sugar beet line is not materially different in composition, safety, or other relevant parameters from sugar beet 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 BNF0056 and that will be maintained in the Office of Premarket Approval.

Based on the information Monsanto and Novartis have presented to FDA, we have no further questions concerning the glyphosate-tolerant sugar beet, line 77, at this time. However. as you are aware, it is Monsanto's and Novartis's continued responsibility to ensure that foods the firms market are safe, wholesome, and in compliance with all applicable legal and regulatory requirements.

^* The Office of Premarket Approval became the Office of Food Additive Safety on June 18, 2001.