U. S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
Office of Food Additve Safety
July 18, 2002

Andrew J. Reed, Ph.D.
Monsanto Company
700 Chesterfield Parkway North
St. Louis, Missouri 63198

Dear Dr. Reed:

This is in regard to Monsanto's consultation with the Food and Drug Administration (FDA) (Center for Veterinary Medicine and Center of Food Safety and Applied Nutrition) on its genetically engineered Bollgard II cotton line 15985. According to Monsanto, this new line, 15985, is designed to express the modified Cry2Ab and beta-glucuronidase (GUS) proteins in addition to the Cry1Ac and neomycin phosphotransferase type II proteins already present in the host cotton variety DP50B. Cotton variety DP50B was derived from crossing the cotton line DP50 with the bioengineered Bollgard cotton line 531. Bollgard cotton line 531 was the subject of BNF 000013. The modified Cry2Ab protein confers additional resistance to lepidopteran pests, including cotton bollworm, tobacco budworm, and pink bollworm. The modified GUS protein is used as a scorable marker. All materials relevant to this notification have been placed in a file designated BNF 0074. 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 Bollgard II cotton, line 15985, dated June 29, 2000. Monsanto provided additional information in submissions dated December 18, 2000; August 10, 2001; February 4, 2002; and March 12, 2002. 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 cotton seed, refined oil, and toasted meal derived from this new variety, are not materially different in composition, safety, and other relevant parameters from cotton seed, refined oil, and toasted meal currently on the market and that the genetically engineered cotton 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 modified Cry2Ab and GUS proteins. It is Monsanto's responsibility to obtain all appropriate clearances, including those from EPA and the United States Department of Agriculture, before marketing food or feed derived from Bollgard II cotton line 15985.

Based on the information Monsanto has presented to FDA, we have no further questions concerning cotton seed, refined oil, and toasted meal derived from Bollgard II cotton line 15985 plant 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.