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Notifications, FY 1998 to Present

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MCAN (Microbial Commercial Activity Notice)

CASE NUMBER DATE RECEIVED MICROORGANISM DECISION DECISION DATE NOC RECEIVED DATE
J98-0001 03/16/98 Bacillus amyloliquefaciens strain MOL1350 Dropped from review 06/14/98  
J98-0002 03/16/98 Bacillus lentus strain PL2958 Dropped from review 06/14/98  
J98-0003 07/09/98 Pseudomonas flourescens strain CBI Dropped from review 10/06/98 02/16/99
J99-0001 02/16/99 Pseudomonas flourescens strain CBI Dropped from review 04/18/99 11/14/02
J01-0001 11/14/00 E. coli strain CBI Dropped from review 03/28/01 01/09/02
J01-0002 11/14/00 E. coli strain CBI Dropped from review 03/28/01 06/10/02
J02-0001 11/19/01 Escherichia coli strain BL21 Dropped from review 03/06/02  
J03-0001 06/25/03 Trichoderma reesei strain CBI Dropped from review 09/10/03 
J03-0002 06/25/03 Trichoderma reesei strain CBI Dropped from review 09/10/03 03/24/04
J04-0001 01/02/04 Trichoderma reesei strain 34-6 Dropped from review 03/24/04 
J04-0002 04/07/04 Withdrawn by submitter    
J04-0003 08/02/04 DVSA-LAC-001 Dropped from review 10/27/0405/25/05
J04-0004 08/05/04 recombinant microorganism Dropped from review 10/27/0412/14/05
J04-0005 09/28/04 Trichoderma reesei strain 23-1 Dropped from review 12/06/04 2/28/08
J05-0001 01/24/05 Trichoderma reesei strain 3236 Dropped from review 03/31/0508/29/06
J05-0002 09/12/05 Trichoderma reesei strain 3243 Dropped from review 12/08/0508/28/06
J06-0001 03/24/06 Trichoderma reesei strain 3260 Dropped from review 06/02/0608/29/06
J07-0001 12/01/06 Trichoderma reesei strain CBI Dropped from review 02/21/0705/09/07
J07-0002 05/28/07 Trichoderma reesei strain 3277 Dropped from review 08/25/0710/10/07
J07-0003 to -0008 08/17/07 consolidated - six organic acid-producing organisms CBI Dropped from review 11/08/07(J-07-0008 only) 02/20/08
J08-0001 05/14/08 Escherichia coli strain BD26981 Dropped from review 08/08/08 
J08-0002 05/14/08 Klebsiella oxytoca strain BD26985 Dropped from review 08/08/08 
J08-0003 07/11/08 Biopolymer Producing Organism Dropped from review 12/01/08 
J09-0001 02/25/09 Trichoderma reesei strain 3309 Dropped from review 05/25/09 
J09-0002 02/27/09 Trichoderma reesei strain CBI Dropped from review 6/15/09 09/18/09
J09-0003 09/02/09 Zymomonas mobilis strain ZW801 Dropped from review 11/30/09 
J09-0004 09/03/09 Trichoderma reesei strain CBI Dropped from review 12/01/09 
J10-0001 10/01/09 Escherichia coli strain W-BD28512 Dropped from review 01/07/10 
J10-0002 11/02/09 Trichoderma reesei strain CBI Dropped from review, with SNUR 02/18/10 
J10-0003 06/03/10 Trichoderma reesei strain 3408 Dropped from review 08/31/10 
J11-0001 10/26/10 Saccharomyces cerevisiae modified Dropped from review 05/19/11 
J11-0002 01/26/11 Komagataella pastoris Dropped from review 06/24/11 
J11-0004 04/14/11 Trichoderma reesei strain 3417 Dropped from review 08/4/11 
J11-0005 08/04/11 Trichoderma reesei strain CBI Dropped from review 12/12/11 
J11-0006 08/15/11 Trichoderma reesei strain CBI Dropped from review 12/12/11 
J12-0002 12/06/11 Zymomonas mobilis strain XA111 Dropped from review 03/01/12 


TERA (TSCA Environmental Release Application)

CASE NUMBER DATE RECEIVED MICROORGANISM DECISION DECISION DATE
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
R07-0001 02/28/07 Pseudomonas putida strain TVA8 Approved 04/20/07
  Invalid  
R06-0003 08/09/06   Invalid  
R07-0001 02/28/07 Pseudomonas putida strain TVA8 Approved 04/20/07


TMEA (Test Market Exemption Application)

CASE NUMBER DATE RECEIVED MICROORGANISM DECISION DECISION DATE
T06-0009** 09/14/06 Organic acid producing organism Grant 12/21/06

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

Selecting linked entries in the "Case Number" column will lead to summaries of each submission. Selecting the linked entries in the "Decision" column will lead to fact sheets on that decision. (NOTE: Factsheets are not prepared for all decisions and, therefore, not all decision entries are underlined.)

KEY:
The tracking codes in the "Case Number" column:

  • The letter J indicates the submission is an MCAN (Microbial Commercial ActivityNotice);
  • The letter R indicates the submission is a TERA (TSCA Environmental Release Application);
  • The first two numbers after the letter indicate the year in which the submission was received;
  • The numbers after the year indicate the order in which the submissions were received.

In the Microorganism 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:

  • 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 can not 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.

    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. Because all TERAs involve releases to the environment, fact sheets will be prepared for all decisions on TERAs.

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.


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