Biotechnology Consultation
Agency Response Letter
BNF No. 000087

Donald M. Lucas, Ph.D.
Regulatory Affairs Manager
Monsanto Company
800 North Lindbergh Boulevard
St. Louis, Missouri 63167

Dear Dr. Lucas:

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) regarding the genetically engineered maize event LY038. According to Monsanto, this new maize event is engineered to produce one new protein, dihydrodipicolinate synthase (cDHDPS). This enzyme is expressed primarily in the grain germ and results in an increased amount of free lysine in the grain. All materials relevant to this notification have been placed in a file designated BNF 0087. 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, on August 10, 2004, a summary of its safety and nutritional assessment of the genetically engineered maize (also known as corn). Monsanto submitted additional information on November 1, 2004, and February 22, 2005. 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 maize grain and forage derived from the new variety are not materially different in composition, safety, and other relevant parameters from maize grain and forage currently on the market, with the exception of the intentionally-increased lysine content in the grain. Further, Monsanto has concluded that the genetically engineered maize does not raise issues that would require premarket review or approval by FDA.

It is the responsibility of Monsanto 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 maize event LY038.

Based on the information Monsanto has presented to FDA, we have no further questions concerning grain and forage derived from maize event LY038 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