Biotechnology Consultation Agency Response Letter BNF No. 000003
Return to inventory: Completed Consultations on Foods from Genetically Engineered Plant Varieties
April 5, 1995
Ms. Anne Mueller
Regulatory and Public Affairs
Zeneca Plant Science
1800 Concord Pike
Wilmington, DE 19897
Dear Ms. Mueller:
This is in regard to your genetically modified processing tomato about which you initiated consultations with the agency in the Fall of 1992. The new tomato variety has been modified to inhibit production of the enzyme polygalacturonase (PG) by insertion of a fragment of the tomato PG gene.
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 tomato variety on September 6, 1994. On September 20, 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 Zeneca 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 that the new tomato variety is substantially equivalent in composition, safety, or any other relevant parameter to tomato 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 0003 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 tomato 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 Zeneca's continued responsibility to ensure that foods the firm markets are safe, wholesome and in compliance with all applicable legal and regulatory requirements.
Alan M. Rulis, Ph.D.
Office of Premarket Approval
Center for Food Safety and Applied Nutrition