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U.S. Department of Health and Human Services

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Biotechnology Consultation Agency Response Letter BNF No. 000080

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. 000080 for further details

July 22, 2004

William P. Pilacinski, Ph.D.
Regulatory Affairs Manager
Monsanto Company
St. Louis, MO 63167

Dear Dr. Pilacinski:

This is in regard to Monsanto Company's (Monsanto) consultation with the Food and Drug Administration (FDA) (Center for Veterinary Medicine and Center for Food Safety and Applied Nutrition) on its genetically engineered wheat event MON 71800. According to Monsanto, this new line is engineered to express CP4 5-enolpyruvylshikimate-3-phosphate synthase (CP4 EPSPS) protein which confers tolerance to glyphosate herbicide. In a letter to FDA dated June 9, 2004, Monsanto states that the firm is deferring all further commercial development efforts to introduce glyphosate-tolerant wheat until such time that other wheat biotechnology traits are introduced. In its letter, Monsanto requests that FDA complete the consultation process for glyphosate-tolerant wheat event MON 71800. All materials relevant to this notification have been placed in a file designated BNF 0080. 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 wheat on June 28, 2002. Monsanto provided additional information in a submission dated April 25, 2003. 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 the wheat grain and forage derived from the new variety are not materially different in composition, safety, and other relevant parameters from wheat grain and forage currently on the market and that the genetically engineered wheat 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 genetically engineered wheat event MON 71800.

Based on the information Monsanto has presented to FDA, we have no further questions concerning grain and forage derived from glyphosate-tolerant wheat event MON 71800 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,


 

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