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TSCA Biotechnology Notifications, FY 1998 to Present
NOTE: At 640X480 screen resolution, you may need to scroll sideways to read the entire table.
The Biotechnology Notifications Table here lists only those submissions received under the biotechnology regulation, beginning in FY 1998. From this table you can link to a brief summary of each submission and, in many cases, to a fact sheet on the decision reached by OPPT. For submissions prior to 1998, go to the Status Report of TSCA Biotechnology Submissions from Fiscal Year 1987 to Fiscal Year 1998 (PDF) (31 pp, 72K, about PDF)
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: Fact sheets 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 Activity Notice);
- 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 EPA received the submission;
- The numbers after the year indicate the order in which EPA received the submissions.
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.
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 | ||||
| J04-0003 | 08/02/04 | DVSA-LAC-001 | Dropped from review | 10/27/04 | 05/25/05 |
| J04-0004 | 08/05/04 | recombinant microorganism | Dropped from review | 10/27/04 | 12/14/05 |
| 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 | 03/31/05 | 08/29/06 |
| J05-0002 | 09/12/05 | Trichoderma reesei strain 3243 | Dropped from review | 12/08/05 | 08/28/06 |
| J06-0001 | 03/24/06 | Trichoderma reesei strain 3260 | Dropped from review | 06/02/06 | 08/29/06 |
| J07-0001 | 12/01/06 | Trichoderma reesei strain CBI | Dropped from review | 02/21/07 | 05/09/07 |
| J07-0002 | 05/28/07 | Trichoderma reesei strain 3277 | Dropped from review | 08/25/07 | 10/10/07 |
| 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 | 06/15/09 | 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 | 10/21/10 |
| 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 | 10/20/10 |
| J10-0003 | 06/03/10 | Trichoderma reesei strain 3408 | Dropped from review | 08/31/10 | 10/20/10 |
| 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 | 08/04/11 | 03/10/12 |
| J11-0005 | 08/04/11 | Trichoderma reesei strain CBI | Dropped from review | 12/12/11 | 07/19/12 |
| J11-0006 | 08/15/11 | Trichoderma reesei strain CBI | Dropped from review | 12/12/11 | 07/19/12 |
| J12-0001 | 12/27/11 | Pichia pastoris (also known as Komagataella phaffii) strain X-33 | Dropped from review | 04/09/12 | |
| J12-0002 | 12/06/11 | Zymomonas mobilis strain XA111 | Dropped from review | 03/01/12 | |
| J12-0004 | 04/26/12 | Saccharomyces cerevisiae strain CBI | Dropped from review | 07/19/12 | |
| J12-0005 | 05/22/12 | Saccharomyces cerevisiae strain CBI | Dropped from review | 08/16/12 | |
| J12-0007 | 08/28/12 | Saccharomyces cerevisiae strain CBI | Dropped from review | 11/25/12 | |
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 | |||
| 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."