Biotechnology Consultation
Agency Response Letter
BNF No. 000090

Ronald W. Schneider
Monsanto Company; E3NB
800 N. Lindbergh Blvd.
St. Louis, MO 63167

Dear Mr. Schneider:

This is in regard to the consultation that Monsanto Company (Monsanto) and KWS SAAT AG (KWS) initiated with the Food and Drug Administration (FDA) (Center for Veterinary Medicine and Center for Food Safety and Applied Nutrition) on their genetically engineered sugar beet event H7-1. According to Monsanto and KWS, this new event is engineered to express one 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 0090. 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 KWS jointly submitted a summary of their safety and nutritional assessment of the genetically engineered sugar beet dated April 16, 2003. Monsanto and KWS submitted additional information in a submission dated December 4, 2003. These communications informed the FDA of the steps taken by Monsanto and KWS 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 KWS have conducted, it is our understanding that Monsanto and KWS have concluded that sugar beet brei (processed root) and tops from the new variety are not materially different in composition, safety, and other relevant parameters from sugar beet brei and tops currently on the market, and that the genetically engineered sugar beet does not raise issues that would require premarket review or approval by FDA.

It is the responsibility of Monsanto and KWS 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 sugar beet event H7-1.

Based on the information Monsanto and KWS have presented to FDA, we have no further questions concerning brei and tops from sugar beet event H7-1 at this time. However, as you are aware, it is Monsanto and KWS's continued responsibility to ensure that foods marketed by the firms are safe, wholesome, and in compliance with all applicable legal and regulatory requirements.

Sincerely yours,

/s/

Laura M. Tarantino, Ph.D.
Director
Office of Food Additive Safety
Center for Food Safety
    and Applied Nutrition