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U.S. Department of Health and Human Services


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NPC 000011: Agency Response Letter

CFSAN/Office of Food Additive Safety

January 29, 2010

Ms. Natalie Weber
Registration Manager
Pioneer Hi-Bred International, Inc., a DuPont Company
DuPont Agriculture and Nutrition P.O. Box 80353
Wilmington, DE 19880-0353

Re: NPC 00011: modified maize alpha-amylase, ZM-AA1

Dear Ms. Weber:

This letter is in response to Pioneer Hi-Bred International, Inc.’s (Pioneer) early food safety evaluation of the protein, a modified maize alpha-amylase, ZM-AA1, expressed in a new plant variety under development for seed selection, which you submitted to the Food and Drug Administration (FDA) on June 23, 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 00011. 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-AA1 protein 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