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U.S. Department of Health and Human Services

New Protein Consultations (Early Food Safety Evaluation)

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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 Use. 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 its date.
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Records Found: 18 Page 1 of 1
  NPC
Submission
   No

(sorted Z-A)
Protein Developer Date Received
Submission - file size
Date of FDA's
Response Letter
18 AC1 glucanase Agrivida, Inc. Oct 5, 2017
(3.7 MB)
Feb 21, 2018
(227 kB)
17 isopentenyltransferase (IPT) Arcadia Biosciences, Inc. Apr 3, 2017
(PDF, 8.1 MB)
Jun 23, 2017
(PDF, 39 kB)
16 homeobox domain HAHB4 protein (HAHB4) Verdeca, Inc. Apr 22, 2015
(PDF, 568 kB)
Aug 7, 2015
15 modified Escherichia coli phytase (Phy02) Agrivida, Inc. Mar 25, 2015
(PDF, 2.9 MB)
Aug 7, 2015
14 trypsin Applied Biotechnology Institute Mar 25, 2015
(PDF, 148 kB)
Sep 2, 2015
13 alanine aminotransferase (AlaAT) Arcadia Biosciences, Inc. Jan 5, 2015
(PDF, 2.2 MB)
May 14, 2015
12 5-enolpyruvateshikimate-3 phosphate synthase (EPSPS ACE5) Athenix Corporation Oct 7, 2009
(PDF, 596 kB)
Oct 15, 2010
11 alpha-amylase ZM-AA1 Pioneer Hi-Bred International, Inc. Jun 23, 2009
(PDF, 319 kB)
Jan 29, 2010
10 p-hydroxyphenylpyruvate dioxygenase (HPPD) Bayer CropScience LP Jun 5, 2009
(PDF, 121 kB)
Mar 26, 2010
(withdrawn*)
9 aryloxyalkanoate dioxygenase-12 (AAD-12) Dow AgroSciences LLC Dec 17, 2008
(PDF, 1384 kB)
May 19, 2010
8 aryloxyalkanoate dioxygenase 1 (AAD 1) Dow AgroSciences LLC Sep 13, 2007
(PDF, 552 kB)
May 19, 2010
7 aryloxyalkanoate dioxygenase 1 (AAD 1) Dow Agrosciences LLC Mar 28, 2007
(PDF, 27 kB)
Dec 22, 2009
(withdrawn*)
6 modified corn acetolactate synthase, ZM-HRA Pioneer Hi-Bred International, Inc Feb 20, 2007
(PDF, 148 kB)
Dec 15, 2009
5 glyphosate N-acetyltransferase GAT4621 Pioneer Hi-Bred International, Inc Feb 5, 2007
(PDF, 155 kB)
Oct 7, 2009
4 red fluorescent protein, DsRed2 Pioneer Hi-Bred International, Inc. Oct 17, 2006
(PDF, 112 kB)
Jan 29, 2010
3 glyphosate N-acetyltransferase GAT4601 Pioneer Hi-Bred International, Inc. Jun 19, 2006
(PDF, 252 kB)
Mar 25, 2009
2 phosphomannose isomerase (PMI) Syngenta Seeds, Inc. Apr 21, 2005
(PDF, 1285 kB)
Feb 10, 2009
1 AMY797E alpha-amylase Syngenta Seeds, Inc. Apr 21, 2005
(PDF, 1235 kB)
Feb 10, 2009

* Withdrawn without prejudice to a future submission.
  NPC
Submission
   No

(sorted Z-A)
Protein Developer Date Received
Submission - file size
Date of FDA's
Response Letter

679662  

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