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U.S. Department of Health and Human Services

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Biotechnology Consultation Agency Response Letter BNF No. 000119

See FDA's memo on BNF No. 000119 for further details

CFSAN/Office of Food Additive Safety

August 18, 2010

Qinghua Zhu, Ph.D.
Regulatory Affairs Manager
Monsanto Company
800 North Lindbergh Boulevard
St. Louis, Missouri 63167

Dear Dr. Zhu:

This is in regard to the 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 soybean line MON 87701. According to information Monsanto has provided, soybean line MON 87701 is genetically engineered to express the Cry1Ac protein. The protein is intended to confer resistance to targeted Lepidopteran pests. All materials relevant to this notification have been placed in a file designated BNF 0119. 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 soybean on May 28, 2009. Monsanto submitted additional information on December 16, 2009. These communications informed 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 food and feed derived from soybean line MON 87701 are not materially different in composition, safety, and other relevant parameters from soybean-derived food and feed currently on the market, and that genetically engineered soybean line MON 87701 does not raise issues that would require premarket review or approval by FDA.

The Environmental Protection Agency (EPA) regulates plant-incorporated protectants (PIP), which include both the active and inert ingredients. Soybean line 87701 contains a PIP, which is within the purview of EPA. 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 soybean line MON 87701.

Based on the information Monsanto has presented to FDA, we have no further questions concerning food and feed derived from soybean line MON 87701 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,

Mitchell A. Cheeseman, Ph.D.
Acting Director
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition