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U.S. Department of Health and Human Services

NPC - New Protein Consultations

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The inventory below lists all New Protein consultations completed under FDA’s 2006 Guidance to Industry: Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use6. For each completed consultation, the inventory contains:

  • the New Protein Consultation (NPC) Number
  • the name of the protein
  • the name of the developer
  • the date that FDA received the developer’s Early Food Safety Evaluation
  • the date of FDA’s response letter

To view the developer’s Early Food Safety Evaluation, click on the PDF hyperlink under the date it was received. To view FDA’s response letter, click on the hyperlink under the date completed.

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Records Found: 18 Page 1 of 1
NPC No.
(sorted Z-A)
Protein Developer Date Received
NPC Submission
Date Completed
Letter
18 AC1 glucanase Agrivida, Inc. Oct 5, 2017
NPC in PDF, 3.7 MB
Feb 21, 2018
FDA's response in PDF, 227 kB
17 isopentenyltransferase (IPT) Arcadia Biosciences, Inc. Apr 3, 2017
NPC in PDF, 8.1 MB
Jun 23, 2017
FDA's Response in PDF, 39 kB
16 homeobox domain HAHB4 protein (HAHB4) Verdeca, Inc. Apr 22, 2015
NPC in PDF, 568 kB
Aug 7, 2015
FDA's Response
15 modified Escherichia coli phytase (Phy02) Agrivida, Inc. Mar 25, 2015
NPC in PDF, 2.9 MB
Aug 7, 2015
FDA's Response
14 trypsin Applied Biotechnology Institute Mar 25, 2015
NPC in PDF, 148 kB
Sep 2, 2015
FDA's Response
13 alanine aminotransferase (AlaAT) Arcadia Biosciences, Inc. Jan 5, 2015
NPC in PDF, 2.2 MB
May 14, 2015
FDA's Response
12 5-enolpyruvateshikimate-3 phosphate synthase (EPSPS ACE5) Athenix Corporation Oct 7, 2009
NPC in PDF, 596 kB
Oct 15, 2010
FDA's Response
11 alpha-amylase ZM-AA1 Pioneer Hi-Bred International, Inc. Jun 23, 2009
NPC in PDF, 319 kB
Jan 29, 2010
FDA's Response
10 p-hydroxyphenylpyruvate dioxygenase (HPPD) Bayer CropScience LP Jun 5, 2009
NPC in PDF, 121 kB
Mar 26, 2010
FDA's Response
withdrawn*
9 aryloxyalkanoate dioxygenase-12 (AAD-12) Dow AgroSciences LLC Dec 17, 2008
NPC in PDF, 1384 kB
May 19, 2010
FDA's Response
8 aryloxyalkanoate dioxygenase 1 (AAD 1) Dow AgroSciences LLC Sep 13, 2007
NPC in PDF, 552 kB
May 19, 2010
FDA's Response
7 aryloxyalkanoate dioxygenase 1 (AAD 1) Dow Agrosciences LLC Mar 28, 2007
NPC in PDF, 27 kB
Dec 22, 2009
FDA's Response
withdrawn*
6 modified corn acetolactate synthase, ZM-HRA Pioneer Hi-Bred International, Inc Feb 20, 2007
NPC in PDF, 148 kB
Dec 15, 2009
FDA's Response
5 glyphosate N-acetyltransferase GAT4621 Pioneer Hi-Bred International, Inc Feb 5, 2007
NPC in PDF, 155 kB
Oct 7, 2009
FDA's Response
4 red fluorescent protein, DsRed2 Pioneer Hi-Bred International, Inc. Oct 17, 2006
NPC in PDF, 112 kB
Jan 29, 2010
FDA's Response
3 glyphosate N-acetyltransferase GAT4601 Pioneer Hi-Bred International, Inc. Jun 19, 2006
NPC in PDF, 252 kB
Mar 25, 2009
FDA's Response
2 phosphomannose isomerase (PMI) Syngenta Seeds, Inc. Apr 21, 2005
NPC in PDF, 1285 kB
Feb 10, 2009
FDA's Response
1 AMY797E alpha-amylase Syngenta Seeds, Inc. Apr 21, 2005
NPC in PDF, 1235 kB
Feb 10, 2009
FDA's Response

*"withdrawn" indicates that the developer requested that FDA cease its evaluation of the submission.
NPC No.
(sorted Z-A)
Protein Developer Date Received
NPC Submission
Date Completed
Letter

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