Reviewing New Chemicals under the Toxic Substances Control Act (TSCA)

Statistics for the New Chemicals Review Program under TSCA

Since the TSCA Inventory was established in 1979, EPA has reviewed more than 39,000 new chemical submissions (called Premanufacture Notices or PMNs) and an additional 15,000 PMN exemption notices. Here is a breakdown of the submissions and notices.

Type of Submission

Number Submitted Since 1979

FY 2015 FY 2014 FY 2013
New Chemicals Program Activities through September 30, 2015
Premanufacture Notices 39,962 589 657 637
Test Marketing Exemption Applications (TMEA) 883 15 4 24
Low Volume Exemptions (LVE) 12,919 399 434 399
Low Release/Low Exposure Exemption (LoRex) 104 2 6 7
Polymer Exemptions*        
Microbial Commercial Activity Notice (MCAN) 106 34 21 14
Significant New Use Notice (SNUN) 52 5 13 7
Total** 54,026 1,088 1,135 1,044
Notices of Commencement (NOC)*** 13,933 267 395 403
Regulatory Action on PMNs Total Number Issued FY 2015 FY 2014 FY 2013
Section 5(e) Consent Orders 1,710 48 20 30
SNURs following section 5(e),
Consent Orders - subset
(739) (28) (36) (40)
SNURs following PMN review 1,457 131 95 157
PMNs withdrawn in face of action 2,068 53 52 66

* Since May 30, 1995, individual reporting for exempt polymers has not been required; reporting is now on a yearly basis on January 31 of the following year.
** Total includes Exemption modifications
***The number of NOCs received during the listed Fiscal Year

Approximately 10 percent of the 39,000 total PMN submissions have resulted in issuance of section 5(e) consent orders that impose various restrictions and testing requirements, and notices withdrawn in the face of regulation. For exemption notices, EPA can grant or deny the notice, with or without certain conditions of use specified in the notice, to which the submitter is legally bound.

Section 5(e) Consent Orders

More than 1,700 of all new chemicals submitted as PMNs have been subject to consent orders under TSCA section 5(e). Such "section 5(e) consent orders" serve to limit the production, processing, distribution in commerce, use, and disposal of new chemical substances that raise health or environmental concerns, pending receipt of required information.

Significant New Use Rules (SNURS)

A subset of 739 of the above-mentioned consent orders have associated with them a SNUR, issued by EPA under TSCA section 5(a)(2). In general, these SNURs mimic the Consent Order to bind all other manufacturers and processors to the terms and conditions contained in the Consent Order. For such chemical substances, persons are required to submit a Significant New Use Notice (SNUN) to EPA at least 90 days before they manufacture, import, or process the substance for the use designated as significant. The required SNUN provides EPA with the opportunity to evaluate the intended use, and if necessary, to prohibit or limit that activity before it occurs.

In addition to these 739 SNURs, an additional 1,457  new chemical substances were regulated by EPA with SNURs which require notice to EPA for potential new uses of the chemical (other than those reviewed as part of the PMN) that may pose unreasonable risks.


In more than 2,000 cases, companies have withdrawn PMNs in the face of EPA concerns and likely regulatory requirements.