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U.S. Department of Health and Human Services


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Inventory of New Protein Consultations

In June 2006, FDA announced final guidance describing procedures for the early food safety evaluation of new non-pesticidal proteins  produced by new plant varieties that are intended for food (the early food safety evaluation guidance), such as proteins produced in bioengineered plants.  Submissions to the agency under the early food safety evaluation guidance are designated New Protein Consultations or NPCs.  The following inventory lists the submissions received by FDA by the assigned NPC number, with the name of the submitter of the NPC, the date received, the name of the protein and the date of FDA's response letter.  Hyperlinks in the column labeled "NPC Submission No." access the company's submission in pdf format; hyperlinks in the column labeled "Date of FDA's Response" access a copy of the text of the agency's response letter. 


Inventory of New Protein Consultations

NPC Submission No.

CompanyDate ReceivedProtein

Date of FDA's Response Letter

12Athenix Corporation10/07/20095-enolpyruvateshikimate-3 phosphate synthase (EPSPS ACE5)10/15/2010
11Pioneer Hi-Bred International, Inc.06/23/2009alpha-amylase ZM-AA101/29/2010
10Bayer CropScience LP06/05/2009p-hydroxyphenylpyruvate dioxygenase (HPPD)03/26/2010 *
9Dow AgroSciences LLC12/17/2008aryloxyalkanoate dioxygenase-12 (AAD-12)05/19/2010
8Dow AgroSciences LLC09/13/2007aryloxyalkanoate dioxygenase 1 (AAD 1)05/19/2010
7Dow Agrosciences LLC03/28/2007aryloxyalkanoate dioxygenase 1 (AAD 1)12/22/2009 *
6Pioneer Hi-Bred International, Inc02/20/2007modified corn acetolactate synthase, ZM-HRA12/15/2009
5Pioneer Hi-Bred International, Inc02/5/2007glyphosate N-acetyltransferase GAT462110/07/2009
4Pioneer Hi-Bred International, Inc.10/17/2006red fluorescent protein, DsRed201/29/2010
3Pioneer Hi-Bred International, Inc.06/19/2006glyphosate N-acetyltransferase GAT460103/25/2009
2Syngenta Seeds, Inc.04/21/2005phosphomannose isomerase (PMI)02/10/2009
1Syngenta Seeds, Inc.04/21/2005AMY797E alpha-amylase02/10/2009


*Withdrawn without prejudice to a future submission


Other Bioengineered Plant Food Submissions

Evaulation of Bioengineered New Plant Varieties: Other Submission Types