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U.S. Department of Health and Human Services


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NPC 000006: Agency Response Letter

CFSAN/Office of Food Additive Safety

December 15, 2009


Ms. Tracy A. Rood
Sr. Registration Manager for North America
Pioneer Hi-Bred International, Inc.
2450 SE Oak Tree Court
Ankeny, IA 50021


Re: NPC 000006; modified maize acetolactate synthase, ZM-HRA

Dear Ms. Rood:

This letter is in response to Pioneer Hi-Bred International, Inc.’s (Pioneer) early food safety evaluation of the protein, a modified maize acetolactate synthase, ZM-HRA, expressed in a new plant variety under development for food use, which you submitted to the Food and Drug Administration (FDA) on February 13, 2007, 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 000006. This file will be maintained in the Office of Food Additive Safety in the Center for Food Safety and Applied Nutrition.

In cases of inadvertent low level presence in the food supply of a new food plant variety, FDA believes that any food or feed safety concern would be limited to the safety of the new protein(s) in that plant (generally, the potential allergenicity and toxicity of the new protein(s)). Based on Pioneer’s early food safety evaluation, it is our understanding that Pioneer has concluded that ZM-HRA would not raise food safety concerns when it is in a new food plant variety that is present at low levels in the food supply. We have completed our evaluation of your submission, and we have no questions at this time regarding Pioneer’s conclusion.


Sincerely yours,

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