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U.S. Department of Health and Human Services


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NPC 000012: Agency Response Letter

CFSAN/Office of Food Additive Safety

October 15, 2010


Lori Artim
Regulatory Affairs Director
Athenix Corporation
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.

In 1996, FDA issued guidance on consultation procedures for foods derived from new plant varieties (accessed by selecting the "Guidance Documents: Biotechnology Safety Assessments" link in the right panel of the Biotechnology section of the Food category in www.fda.gov). We anticipate that Athenix will continue to interact with us under those consultation procedures prior to marketing food derived from new plant varieties.



Sincerely yours

Antonia Mattia, Ph.D.
Division Director
Division of Biotechnology and GRAS Notice Review
Center for Food Safety and Applied Nutrition