Biotechnology Consultation
Agency Response Letter
BNF No. 000004

Mr. Don Emlay
Vice President, Regulatory affairs
Calgene, Inc.
1920 Fifth Street
Davis, CA 95616

Dear Mr. Emlay:

This is in regard to your genetically modified bromoxynil tolerant cotton about which you initiated consultations with the agency in August 1992. The new cotton variety has been rendered tolerant to bromoxynil by expression of a nitrilase from Klebsiella ozaenae.

As part of bringing your consultation with FDA regarding this product to closure, you submitted a summary of your safety and nutritional assessment of the new cotton variety on June 14, 1994. On October 21, 1994, you also made a detailed oral presentation of the data that support your submission. It is our understanding that these communications were intended by Calgene to inform FDA of the steps taken to ensure that this product complies with those legal and regulatory requirements that fall within FDA's jurisdiction. Further, it is our understanding that, based on the safety and nutritional assessment you have conducted, you have concluded, in essence, that the new cotton variety is not significantly altered in composition, safety, or any other relevant parameter from cotton varieties currently on the market and that it does not raise issues that would require premarket review or approval by FDA. All materials relevant to this consultation have been placed in a file that has been designated BNF 0004 and that will be maintained in the Office of Premarket Approval.

Based on the description of the data and information presented during the consultations, the new cotton variety does not appear to be significantly altered within the meaning of 21 CFR 170.30(f)(2). We have no additional questions concerning this product at this time. However, as you are aware, it is Calgene's continued responsibility to ensure that foods the firm markets are safe, wholesome and in compliance with all applicable legal and regulatory requirements.