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TSCA Biotechnology Notifications Status

On this page:

On other pages:

For a copy of the non-confidential version of a MCAN, please contact the TSCA Non-Confidential Information Center (NCIC) by phone at 202-566-0280, or by fax at 202-566-9744. 

For submissions prior to 1998, go to the Status Report of TSCA Biotechnology Submissions from Fiscal Year 1987 to Fiscal Year 1998.

The three Biotechnology Notifications Tables below list submissions received under the biotechnology regulation beginning in fiscal year 1998.

Key to Table Contents

The tracking codes in the "Case Number" column:

  • Letter J indicates the submission is an MCAN (Microbial Commercial Activity Notice).
  • Letter R indicates the submission is a TERA (TSCA Environmental Release Application).
  • First two numbers after the letter indicate the year in which EPA received the submission.
  • Numbers after the year indicate the order in which EPA received the submissions.

In the Microorganism, Company, or Use column:

  • The acronym CBI means Confidential Business Information.
  • The MCAN microorganism specific or generic identities displayed on this page are interim, because until a Notice of Commencement of Manufacture (NOC) is submitted, the Agency has yet to determine how the microorganisms will be listed on the TSCA Inventory.

In the Decision Column:

TERAs

TERAs do require approval from EPA. After review of the submission, the Agency may:

  • Deny the submission; or
  • Approve it with or without negotiated conditions.

MCANs

EPA does not "approve" MCANs -- they are reviewed. The Agency may determine that regulatory action is necessary. This action may include:

  • Restricting the manufacture, processing or use of the microorganisms; 
  • Requiring recordkeeping or reporting; or,
  • If necessary, an outright ban on commercialization of the microorganism.

If the Agency cannot conclude that there is an unreasonable risk to health or the environment, or a substantial or significant exposure, the submission is "dropped from review," and the company can begin commercialization after the review period has expired.

In the NOC Column:

  • The acronym "NOC" stands for "Notice of Commencement." Following review, companies must submit an NOC form for MCANs, indicating the date the microorganism is entered into commerce. TERAs do not require NOCs.

MCAN (Microbial Commercial Activity Notice) fiscal year 1998 to present

Case Number Date Received Microorganism Decision Decision Date NOC Received Date Company Use
J-98-0001 03/16/1998 Bacillus amyloliquefaciens strain MOL1350 Dropped from review 06/14/98   Novo Nordisk Biochem North America, Inc. The commercial biosynthesis of an alpha-amylase
J-98-0002 03/16/1998 Bacillus lentus strain PL2958 Dropped from review 06/14/98   Novo Nordisk Biochem North America, Inc. The commercial biosynthesis of a subtilisin protease
J-98-0003 07/09/1998 Pseudomonas flourescens strain CBI Dropped from review 10/06/98 02/16/99 Diversa Corporation The commercial biosynthesis of an enzyme for secondary oil recovery operations
J-99-0001 02/16/1999 Pseudomonas flourescens strain CBI Dropped from review 04/18/99 11/14/02 Diversa Corporation Biosynthesis of a thermostable beta-glucanase enzyme which will be used commercially as a high temperature viscosity breaker to enhance oil recovery operations
J-01-0001 11/14/2000 E. coli strain CBI Dropped from review 03/28/01 01/09/02 Third Wave Technologies Biomedical research and clinical diagnostics
J-01-0002 11/14/2000 E. coli strain CBI Dropped from review 03/28/01 06/10/02 Third Wave Technologies Biomedical research and clinical diagnostics
J-02-0001 11/19/2001 Escherichia coli strain BL21 Dropped from review 03/06/02   Third Wave Technologies Biomedical research and clinical diagnostics
J-03-0001 06/25/2003 Trichoderma reesei strain CBI Dropped from review 09/10/03   CBI company Used to produce enzymes for commercial use
J-03-0002 06/25/2003 Trichoderma reesei strain CBI Dropped from review 09/10/03 03/24/04 CBI company Used to produce enzymes for commercial use
J-04-0001 01/02/2004 Trichoderma reesei strain 34-6 Dropped from review 03/24/04   Genencor International Inc. Used to manufacture a glucoamylase enzyme for commercial use
J-04-0002 04/07/2004   Withdrawn by submitter        
J-04-0003 08/02/2004 DVSA-LAC-001 Dropped from review 10/27/04 05/25/05 Diversa Corporation Used to produce an enzyme for use as a processing aid in the production of fragrances and flavors with a citrus-like fragrance or essence
J-04-0004 08/05/2004 recombinant microorganism Dropped from review 10/27/04 12/14/05 CBI company Used to manufacture a chemical substance
J-04-0005 09/28/2004 Trichoderma reesei strain 23-1 Dropped from review 12/06/04 2/28/08 Genencor International Inc. The production of an alpha-amylase
J-05-0001 01/24/2005 Trichoderma reesei strain 3236 Dropped from review 03/31/05 08/29/06 Genencor International Inc. Used to produce a b-glucosidase preparation
J-05-0002 09/12/2005 Trichoderma reesei strain 3243 Dropped from review 12/08/05 08/28/06 Genencor International Inc. Used to produce an acid protease preparation
J-06-0001 03/24/2006 Trichoderma reesei strain 3260 Dropped from review 06/02/06 08/29/06 Genencor International Inc. Used to produce a glucoamylase enzyme preparation
J-07-0001 12/01/2006 Trichoderma reesei strain CBI Dropped from review 02/21/07 05/09/07 Novozymes, North America, Inc. The synthesis of a cellulose-degrading protein preparation
J-07-0002 05/28/2007 Trichoderma reesei strain 3277 Dropped from review 08/25/07 10/10/07 Danisco US (formerly Genencor International), Inc. The synthesis of phytase
J-07-0003 to -0008 08/17/2007 consolidated - six organic acid-producing organisms CBI Dropped from review 11/08/07 (J-07-0008 only) 02/20/08 CBI company The industrial manufacture of an organic acid
J-08-0001 05/14/2008 Escherichia coli strain BD26981 Dropped from review 08/08/08   Verenium Corporation The conversion of lignocellulosic biomass sugars to fuel grade ethanol
J-08-0002 05/14/2008 Klebsiella oxytoca strain BD26985 Dropped from review 08/08/08   Verenium Corporation The conversion of lignocellulosic biomass sugars to fuel grade ethanol
J-08-0003 07/11/2008 Biopolymer Producing Organism Dropped from review 12/01/08   CBI company The industrial manufacture of a biopolymer
J-09-0001 02/25/2009 Trichoderma reesei strain 3309 Dropped from review 05/25/09   Danisco US (formerly Genencor International), Inc. The synthesis of laccase
J-09-0002 02/27/2009 Trichoderma reesei strain CBI Dropped from review 06/15/09 09/18/09 Novozymes North America, Inc. Used to produce a cellulolytic protein preparation for ethanol production
J-09-0003 09/02/2009 Zymomonas mobilis strain ZW801 Dropped from review 11/30/09   DuPont de Nemours and Company Cellulosic fuel ethanol production
J-09-0004 09/03/2009 Trichoderma reesei strain CBI Dropped from review 12/01/09 10/21/10 Novozymes North America, Inc. Used to produce cellulose-degrading enzymes for ethanol production
J-10-0001 10/01/2009 Escherichia coli strain W-BD28512 Dropped from review 01/07/10   Verenium Corporation Used to ferment C5 sugars from lignocellulosic biomass to ethanol
J-10-0002 11/02/2009 Trichoderma reesei strain CBI Dropped from review, with SNUR 02/18/10 10/20/10 Danisco US (formerly Genencor International), Inc. Used to produce enzymes for ethanol production
J-10-0003 06/03/2010 Trichoderma reesei strain 3408 Dropped from review 08/31/10 10/20/10 Danisco US (formerly Genencor International), Inc. Used to produce enzymes for ethanol production
J-11-0001 10/26/2010 Saccharomyces cerevisiae modified Dropped from review 05/19/11   CBI company Ethanol production
J-11-0002 01/26/2011 Komagataella pastoris Dropped from review 06/24/11   ICx Agentase Used as a fermentation production organism for the manufacturing of the cholinesterase enzyme
J-11-0004 04/14/2011 Trichoderma reesei strain 3417 Dropped from review 08/04/11 03/10/12 Danisco US (formerly Genencor International), Inc. Biofuel production from cellulosic biomass
J-11-0005 08/04/2011 Trichoderma reesei strain CBI Dropped from review 12/12/11 07/19/12 Novozymes North America, Inc. Used to produce a cellulolytic protein preparation to be used for ethanol production
J-11-0006 08/15/2011 Trichoderma reesei strain CBI Dropped from review 12/12/11 07/19/12 Novozymes North America, Inc. The biosynthesis of cellulose-degrading enzymes to be used for ethanol production
J-12-0001 12/27/2011 Pichia pastoris (also known as Komagataella phaffii) strain X-33 Dropped from review 04/09/12   Kemin Industries, Inc. The biofuels industry and for animal feed
J-12-0002 12/06/2011 Zymomonas mobilis strain XA111 Dropped from review 03/01/12   DuPont de Nemours and Company The recipient microorganism was the Zymomonas mobilis wild type strain ZM4. Z. mobilis ZM4 was modified to produce the new organism Z. mobilis XA111. The new microorganism will be able to utilize both xylose and arabinose in ethanol producing fermentation processes.
J-12-0003 03/23/2012 modified microalgae, strain CBI Dropped from review 08/07/13   Solazyme, Inc. Chemical production
J-12-0004 04/26/2012 Saccharomyces cerevisiae strain CBI Dropped from review 07/19/12 11/5/2012 CBI company Ethanol production
J-12-0005 05/22/2012 Saccharomyces cerevisiae strain CBI Dropped from review 08/16/12 8/27/2012 Lallemand Specialties, Inc. Ethanol production
J-12-0006 07/11/2012 modified Synechococcus Regulated with a 5(e) Consent Order 07/23/13   J-oule Unlimited Technologies, Inc. Fuel ethanol production
J-12-0007 08/28/2012 Saccharomyces cerevisiae strain CBI Dropped from review 11/25/12   CBI company Ethanol production
J-13-0001 11/27/2012 Modified microorganism Dropped from review 04/04/13   CBI company Enzyme production
J-13-0003 to -0006 01/11/2013 Saccharomyces cerevisiae modified Dropped from review 04/04/13 04/18/13 (J-13-0003); 04/20/13 (J-13-0005) CBI company Enzyme production
J-13-0007 03/13/2013 Saccharomyces cerevisiae, strain CBI Dropped from review 06/12/13 7/25/2013 CBI company Enzyme production
J-13-0008 04/16/2013 Saccharomyces cerevisiae, strain CBI Dropped from review 07/08/13   Novozymes North America, Inc. Ethanol production
J-13-0009 05/15/2013 Modified microorganism Dropped from review 08/08/13   CBI company Enzyme production
J-13-0010 06/21/2013 Saccharomyces cerevisiae, strain CBI Dropped from review 09/05/13 11/10/13 Danisco US, Inc. Ethanol production
J-13-0030 08/16/2013 modified microalgae, strain CBI Dropped from review 12/14/13 04/10/14 Solazyme, Inc. Chemical production
J-13-0050 06/21/2013 Trichoderma reesei, strain CBI Dropped from review 12/02/13 4/29/2016 Danisco US, Inc. uUproduce α-amylase
J-14-0001 11/27/2013 Saccharomyces cerevisiae modified Dropped from review 02/24/14 5/20/2014 Lessafre Yeast Ethanol production
J-14-0002 11/29/2013 Modified microorganism Dropped from review 04/10/14   CBI company Chemical production
J-14-0003 to -0006 12/02/2013 Saccharomyces cerevisiae modified Dropped from review 02/27/14   DSM Nutritional Products, Inc. Ethanol production
J-14-0007 to -0009 01/08/2014 Enhanced algae Regulated with a 5(e) Consent Order 12/17/14   Algenol Biofuels, Inc. The production of biofuels and fuel intermediates
J-14-0010 02/28/2014 Trichoderma reesei, strain CBI Dropped from review 05/28/14 4/25/2015 Danisco US, Inc. Used to produce a ß-glucosidase enzyme
J-14-0011 to -0015 03/10/2014 Trichoderma reesei, strain CBI Dropped from review 06/05/14 8/17/2015 (J-14-0015) Novozymes North America, Inc. The biosynthesis of cellulose-degrading enzymes to be multiple industrial applications
J-14-0016 03/14/2014 Saccharomyces cerevisiae, CBI strain Dropped from review 06/11/14   CBI company Ethanol production
J-14-0017 04/01/2014 Modified microalgae Dropped from review 07/14/14 8/27/14 Solazyme, Inc. Chemical production
J-14-0018 06/03/2014 Trichoderma reesei, strain CBI Dropped from review 08/31/14   Novozymes North America, Inc. Multiple industrial applications
J-14-0019 07/05/2014 Trichoderma reesei, strain CBI Dropped from review 09/30/14   Danisco US, Inc. Used to produce a (hemi)cellulase complex
J-14-0020 07/07/2014 Modified microalgae Dropped from review 10/06/14 10/21/14 Solazyme, Inc. Chemical production
J-14-0021 09/30/2014 Saccharomyces cerevisiae, CBI strain Dropped from review 12/29/14   Novozymes North America, Inc. Commercial ethanol production.
J-15-0003 1/23/2015 Trichoderma reesei modified Dropped from review 4/2/2015   Novozymes North America, Inc. Enzyme production
J-15-0004 1/23/2015 Trichoderma reesei modified Dropped from review 4/2/2015   Novozymes North America, Inc. Enzyme production
J-15-0005 1/23/2015 Trichoderma reesei modified Dropped from review 4/2/2015   Novozymes North America, Inc. Enzyme production
J-15-0006 1/23/2015 Trichoderma reesei modified Dropped from review 4/2/2015   Novozymes North America, Inc. Enzyme production
J-15-0007 1/30/2015 Escherichia coli B834 GLO Ban pending up front testing 4/22/2015   Glowing Plant, Inc. broad variety of consumer products in both solid and liquid media
J-15-0008 3/18/2015 Saccharomyces cerevisiae modified Dropped from review 6/15/2015   Taurus Energy AB Ethanol production
J-15-0009 3/18/2015 Saccharomyces cerevisiae modified Dropped from review 6/15/2015   Taurus Energy AB Ethanol production
J-15-0010 3/18/2015 Saccharomyces cerevisiae modified Dropped from review 6/15/2015   Taurus Energy AB Ethanol production
J-15-0011 3/18/2015 Saccharomyces cerevisiae modified Dropped from review 6/15/2015   Taurus Energy AB Ethanol production
J-15-0012 3/18/2015 Saccharomyces cerevisiae modified Dropped from review 6/15/2015   Taurus Energy AB Ethanol production
J-15-0013 3/27/2015 Biofuel producing organism Dropped from review 6/19/2015   CBI Company production of biofuel
J-15-0014 3/27/2015 Biofuel producing organism Dropped from review 6/19/2015   CBI Company production of biofuel
J-15-0015 3/27/2015 Biofuel producing organism Dropped from review 6/19/2015   CBI Company production of biofuel
J-15-0016 3/27/2015 Biofuel producing organism Dropped from review 6/19/2015   CBI Company production of biofuel
J-15-0017 3/27/2015 Biofuel producing organism Dropped from review 6/19/2015   CBI Company production of biofuel
J-15-0018 3/27/2015 Biofuel producing organism Dropped from review 6/19/2015   CBI Company production of biofuel
J-15-0019 4/11/2015 Organic acid producing organism Dropped from review 7/9/2015   CBI Company Industrial manufacture of an organic acid
J-15-0020 4/11/2015 Organic acid producing organism Dropped from review 7/9/2015   CBI Company Industrial manufacture of an organic acid
J-15-0021 4/11/2015 Organic acid producing organism Dropped from review 7/9/2015   CBI Company Industrial manufacture of an organic acid
J-15-0022 4/11/2015 Organic acid producing organism Dropped from review 7/9/2015   CBI Company Industrial manufacture of an organic acid
J-15-0023 4/11/2015 Organic acid producing organism Dropped from review 7/9/2015   CBI Company Industrial manufacture of an organic acid
J-15-0024 4/30/2015 Trichoderma reesei modified Dropped from review 7/23/2015   Novozymes North America, Inc. Production of cellulose-degrading enzymes
J-15-0025 4/30/2015 Trichoderma reesei modified Dropped from review 7/23/2015   Novozymes North America, Inc. Production of cellulose-degrading enzymes
J-15-0026 5/1/2015 Trichoderma reesei modified Dropped from review 7/30/2015 10/7/2015 Danisco US, Inc. Production of glucoamylase
J-15-0027 5/4/2015 Saccharomyces cerevisiae modified Dropped from review 7/30/2015   DSM BioProducts & Services Ethanol production
J-15-0028 5/4/2015 Saccharomyces cerevisiae modified Dropped from review 7/30/2015   DSM BioProducts & Services Ethanol production
J-15-0029 5/4/2015 Saccharomyces cerevisiae modified Dropped from review 7/30/2015   DSM BioProducts & Services Ethanol production
J-15-0030 5/4/2015 Saccharomyces cerevisiae modified Dropped from review 7/30/2015   DSM BioProducts & Services Ethanol production
J-15-0031 5/29/2015 Saccharomyces cerevisiae modified Dropped from review 8/6/2015 10/17/2015 Danisco US, Inc. Ethanol production
J-15-0032 7/18/2015 Trichoderma reesei modified Dropped from review 10/8/2015   Danisco US, Inc. Enzyme production
J-15-0033 7/21/2015 Trichoderma reesei modified Dropped from review 10/8/2015   Danisco US, Inc. Enzyme production
J-15-0034 8/10/2015 Saccharomyces cerevisiae modified Dropped from review 11/5/2015 12/21/2015 CBI Company Ethanol production
J-15-0035 8/10/2015 Saccharomyces cerevisiae modified Dropped from review 11/5/2015   CBI Company Ethanol production
J-15-0036 9/4/2015 Zymomonas mobilis modified Dropped from review 11/30/2015   Danisco US, Inc. Ethanol production
J-16-0001 12/14/2015 Trichoderma reesei modified Dropped from review 3/10/2016   Novozymes North America, Inc. Enzyme production
J-16-0002 12/14/2015 Trichoderma reesei modified Dropped from review 3/10/2016   Novozymes North America, Inc. Enzyme production
J-16-0003 2/15/2016 Saccharomyces cerevisiae modified Dropped from review 5/12/2016   DSM BioProducts & Services Ethanol production
J-16-0004 2/24/2016 Saccharomyces cerevisiae modified Dropped from review 5/19/2016   Novozymes North America, Inc. Chemical production
J-16-0005 2/24/2016 Saccharomyces cerevisiae modified Dropped from review 5/19/2016   Novozymes North America, Inc. Chemical production
J-16-0006 3/31/2016 Trichoderma reesei modified Pending Standard Review 4/13/2016   Danisco US, Inc. Enzyme production

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TERA (TSCA Environmental Release Application) fiscal year 1998 to present

Case Number Date Received Microorganism Decision DECISION DATE Location Use
R98-0001 03/02/98 Bradyrhizobium japonicum strain Bj 5019 Approved 05/06/98    
R98-0002 03/02/98 Bradyrhizobium japonicum strain JH 359 Approved 05/06/98    
R98-0003 03/02/98 Bradyrhizobium japonicum strain TN 119 Approved 05/06/98    
R98-0004 07/21/98 Pseudomonas putida strain RB1500 Approved 10/02/98    
R98-0005 07/21/98 Pseudomonas putida strain RB1501 Approved 10/02/98    
R99-0002 04/02/99 Bradyrhizobium japonicum strain Bj 5019 Approved 03/02/99    
R99-0003 04/22/99 Bradyrhizobium japonicum strain TN 119 Approved 03/02/99    
R00-0001 04/12/00 Bradyrhizobium japonicum strain Bj 61A273KS Approved 05/17/00    
R00-0002 01/29/00 Pseudomonas putida strain CBI Approved 10/11/00    
R01-0001 01/03/01 Escherichia coli strain CBI Approved 03/27/02    
R01-0002 03/28/01 Pseudomonas putida strain CBI Approved 05/09/01    
R01-0003 04/25/01 Pseudomonas putida strain CBI Approved 05/30/01    
R01-0004 04/25/01 Pseudomonas putida strain CBI Approved 05/30/01    
R02-0001 06/05/02 Pseudomonas fluorescens strain HK44 Approved 07/31/02    
R03-0001 05/13/03 Alcaligenes xylosoxidans subspecies denitrificans strain AL6.1 Approved 06/25/03    
R04-0001 12/06/03 Pseudomonas flourescens strain HK44 Approved 02/11/04    
R04-0002 12/06/03 Pseudomonas flourescens strain 5RL Approved 02/11/04    
R04-0003 03/17/04 Alcaligenes xylosoxidans subspecies denitrificans strain AL6.1 Approved 04/21/04    
R05-0001 03/07/05 Alcaligenes xylosoxidans subspecies denitrificans strain AL6.1 Approved 05/26/05    
R06-0001 06/06/06   Suspended pending additional information      
R06-0002 08/09/06          
R06-0003 08/09/06   Invalid      
R07-0001 02/28/07 Pseudomonas putida strain TVA8 Approved 04/20/07    
R13-0001 04/24/13 Gordonia terrae, modified Approved 06/17/13 Hermiston, OR bioremediation
R13-0002 04/24/13 Rhodococcus jostii, modified Approved 06/17/13 Hermiston, OR bioremediation
R13-0003 08/01/13 Scenedesmus dimorphus, modified Approved 09/25/13 La Jolla, CA  
R13-0004 08/01/13 Scenedesmus dimorphus, modified Approved 09/25/13 La Jolla, CA  
R13-0005 08/01/13 Scenedesmus dimorphus, modified Approved 09/25/13 La Jolla, CA  
R13-0006 08/01/13 Scenedesmus dimorphus, modified Approved 09/25/13 La Jolla, CA  
R13-0007 08/01/13 Scenedesmus dimorphus, modified Approved 09/25/13 La Jolla, CA  
R15-0001 03/12/15 Bacillus thuringiensis subsp. Israelensis , modified Approved 04/28/15 Columbia, MO Enzyme production
R15-0002 03/12/15 Bacillus thuringiensis subsp. Israelensis, modified Approved 04/28/15 Columbia, MO Enzyme production
R15-0003 05/01/15 Saccharomyces cerevisiae , modified Approved 07/02/2015 Perry, GA Bioindicator

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TMEA (Test Market Exemption Application) fiscal year 1998 to present

Case Number Date Received Microorganism Decision Decision Date Manufacturer Use
T06-0009** 09/14/06 Organic acid producing organism Grant 12/21/06 CBI company industrial manufacture of an organic acid

** Note that TMEA Case Number is currently chronologically grouped with PMNs. In the future, a TMEA will be designated "O" rather than "T."