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U.S. Department of Health and Human Services

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Biotechnology Consultation Agency Response Letter BNF No. 000097

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. 000097 for further details

January 12, 2005

Ravinder S. Sidhu, Ph.D.
Regulatory Affairs Manager
Monsanto Company
800 North Lindbergh Boulevard
St. Louis, Missouri 63167

Dear Dr. Sidhu:

This is in regard to Monsanto Company's (Monsanto) consultation with the Food and Drug Administration (FDA) (Center for Food Safety and Applied Nutrition and Center for Veterinary Medicine) on genetically engineered corn line MON 88017. According to Monsanto, this new line is genetically engineered to express two new proteins, Cry3Bb1 and CP4 5-enolpyruvylshikimate 3-phosphate synthase (CP4 EPSPS). The Cry3Bb1 protein confers resistance to Coleopteran insects such as corn rootworm; CP4 EPSPS confers tolerance to glyphosate and is used as a selectable marker. All materials relevant to this notification have been placed in a file designated BNF 0097. 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 corn on March 30, 2004. Monsanto submitted additional information on May 18, June 22, and October 18, 2004. 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 corn grain and forage derived from the new variety are not materially different in composition, safety, and other relevant parameters from corn grain and forage currently on the market and that genetically engineered corn line MON 88017 does not raise issues that would require premarket review or approval by FDA.

Because the Environmental Protection Agency (EPA) regulates pesticidal substances and pesticidal inert ingredients, FDA has not evaluated the information related to the safety of the Cry3Bb1 and CP4 EPSPS proteins. It is Monsanto's responsibility to obtain all appropriate clearances, including those from the EPA and the United States Department of Agriculture, before marketing food or feed derived from corn line MON 88017.

Based on the information Monsanto has presented to FDA, we have no further questions concerning grain and forage derived from corn line MON 88017 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