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||
||FY 2015||FY 2014||FY 2013|
|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|
|Microbial Commercial Activity Notice (MCAN)||106||34||21||14|
|Significant New Use Notice (SNUN)||52||5||13||7|
|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
|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|PMNs withdrawn in face of action||2,068||53||52||66|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in issuance of section 5(e) consent orders that impose various restrictions and testing requirements, and notices withdrawn in the face of regulation.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.