NPC 000001: Agency Response Letter
CFSAN/Office of Food Additive Safety
February 10, 2009
Syngenta Seeds, Inc.
PO Box 12257
3054 East Cornwallis Road
Research Triangle Park, NC 27709-2257
Re: NPC 00001; AMY797E alpha-amylase
Dear Ms. Tuttle:
This letter is in response to Syngenta Seeds, Inc.’s (Syngenta) early food safety evaluation of the protein AMY797E alpha-amylase expressed in a new plant variety under development for food use, which you submitted to the Food and Drug Administration (FDA) on April 19, 2005, under FDA’s then draft guidance to industry, “Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use” (69 FR 68381-68383; Nov. 24, 2004). The agency issued final guidance on June 21, 2006, which is available on the Internet at http://www.cfsan.fda.gov/~dms/bioprgu2.html*. As used in the guidance and in this letter, the term "food" refers to both human food and animal feed. All materials relevant to this evaluation have been placed in a file designated NPC 00001. This file will be maintained in the Office of Food Additive Safety in the Center for Food Safety and Applied Nutrition.
Based on your early food safety evaluation, it is our understanding that you have concluded that the potential inadvertent presence in the food supply of low levels of AMY797E alpha-amylase protein would not raise food safety concerns. We have completed our evaluation of your submission, and we have no questions at this time regarding your conclusion.
Antonia Mattia, Ph.D.
Division of Biotechnology and GRAS Notice Review
Center for Food Safety and Applied Nutrition
*Note: The Internet reference in the letter above has changed. The final guidance document entitled "Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use" (71 FR 35688; June 21, 2006), is available on the FDA home page at http://www.fda.gov - follow the hyperlinks from the "Food" topic to the "Biotechnology" program area.