NPC 000007: Agency Response Letter
CFSAN/Office of Food Additive Safety
December 22, 2009
Penny L. Hunst, Ph.D.
Global Trait Regulatory Leader - Biotech
Dow AgroSciences LLC
9330 Zionsville Road
Indianapolis, Indiana 46268
Re: New Protein Consultation 00007; aryloxyalkanoate dioxygenase protein (AAD1)
Dear Dr. Hunst:
This letter is in response to Dow AgroSciences LLC (Dow) early food safety evaluation of the protein aryloxyalkanoate dioxygenase (AAD1) expressed in a new plant variety under development for food use, which you submitted to the Food and Drug Administration (FDA) on March 20, 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 Internet at http://www.cfsan.fda.gov/~dms/bioprgu2.html)*.
Based on your letter of September 6, 2007, you requested that your submission be withdrawn from consideration without prejudice to a future submission. Given your letter, we ceased to evaluate your submission on the date that we received your letter.
Antonia Mattia, Ph.D.
Division of Biotechnology and GRAS Notice Review
Office of Food Additive Safety
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.