TSCA Biotechnology Notifications Status For Cases Reviewed Prior to June 22, 2016

This page describes the status of new biotechnology notice reviews conducted prior to passage of the Frank R. Lautenberg Chemical Safety for the 21^st Century Act on June 22, 2016. Biotechnology case reviews conducted after TSCA was amended can be viewed on the Microbial Commercial Activity Notices (MCANs) Table or the Exemptions Table found on the “Status of Pre-Manufacture Notices reviewed under Section 5 of TSCA” page.

On this page:

• Key to table
• Microbial Commercial Activity Notice (MCANs) fiscal year 1998 to present
• TSCA Environmental Release Application (TERAs) fiscal year 1998 to present

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

On other pages:

• TSCA biotechnology submissions fiscal year 1987 to 1998
• TSCA biotechnology submissions June 22, 2016 to present
• TSCA biotechnology overview
• TSCA biotechnology regulations
• Filing a biotechnology submission 

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 and reviewed prior to June 22, 2016.

The three Biotechnology Notifications Tables below list submissions received under the biotechnology regulation beginning in fiscal year 1998 and reviewed prior to June 22, 2016.

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

Prior to passage of the Frank R. Lautenberg Chemical Safety for the 21st Century Act on June 22, 2016, EPA did not "approve" MCANs -- they were reviewed. The Agency could determine that regulatory action was necessary. This action could 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 did not take regulatory action, the submission was "dropped from review," and the company could begin commercialization after the review period had 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 June 22, 2016

TERA (TSCA Environmental Release Application) fiscal year 1998 to June 22, 2016

TMEA (Test Market Exemption Application) fiscal year 1998 to June 22, 2016

** Note that TMEA Case Number is currently chronologically grouped with PMNs.