NPC 000012: Agency Response Letter
CFSAN/Office of Food Additive Safety
October 15, 2010
Regulatory Affairs Director
108 T.W. Alexander Drive
Research Triangle Park, NC 27709
Re: NPC 00012: EPSPS ACE5
This letter is in response to Athenix Corporation’s (Athenix) early food safety evaluation of the protein EPSPS ACE5, a 5-enolpyruvateshikimate-3 phosphate enzyme, expressed in a new plant variety under development for food use, which you submitted to the Food and Drug Administration (FDA) on October 7, 2009, under FDA’s guidance to industry, “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, and available on the FDA home page at http://www.fda.gov - follow the hyperlinks from the “Food” topic to the “Biotechnology” program area). 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 00012. This file will be maintained in the Office of Food Additive Safety in the Center for Food Safety and Applied Nutrition.
Based on Athenix’s early food safety evaluation, it is our understanding that Athenix has concluded that the potential inadvertent presence in the food supply of low levels of EPSPS ACE5 protein would not raise food safety concerns. We have completed our evaluation of your submission, and we have no questions at this time regarding Athenix’s conclusion.
Antonia Mattia, Ph.D.
Division of Biotechnology and GRAS Notice Review
Center for Food Safety and Applied Nutrition