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

Statistics for the New Chemicals Review Program under TSCA

On June 22, 2016, the Frank R. Lautenberg Chemical Safety for the 21st Century Act amended the review of new chemical notices under section 5 of the Toxic Substances Control Act (TSCA). This page provides a summary of the submissions received and actions taken under TSCA before and after the date of enactment.

Statistics under Amended TSCA

EPA is moving swiftly to reduce the backlog of manufacturers’ new chemical requests or pre-manufacturing notices (PMNs) in the EPA review pipeline and to meet the required 90-day review period. To achieve this, EPA has added temporary new staffing to make the process more efficient and to improve manufacturers’ certainty in the process and timelines. EPA continues to work with manufacturers to ensure the Agency has all the information necessary to assess a new chemical’s safety.

At any one time, EPA typically has an average of 300 new chemical cases under review. As the Agency makes final determinations on chemicals already in the review process, decreasing the case load, new requests are being submitted which increases the case load. When the Frank R. Lautenberg Chemical Safety for the 21st Century Act passed on June 22, 2016, EPA had 334 new chemical cases under review. These cases needed to be reassessed under the new law, thus adding to the Agency’s average case load and creating a “backlog.”

EPA is adding new content below, which will be updated weekly, in an effort to be more transparent to the public on the status of the Agency's reviews and to allow submitters to determine the disposition of their cases as quickly as possible. EPA is committed to working with PMN submitters early in the process to provide more certainty and to begin any necessary discussions earlier in the process with the expectation that submitters and EPA can work together to decrease the time needed to complete each review.

Eliminating the Backlog: Actuals and Projected Progress*

Chart: Backlog Actuals and Projected Progress

*EPA reviews about 1,000 new chemicals per year, and must complete the review of each submission within a specified timeframe, resulting in about 300 chemicals under review at any given time.  By January 2017, the number under review had grown to about 600. EPA is working hard to get the number of submissions under review back to the typical baseline by the end of July 2017.

Pre-Manufacture Notices (PMNs), Microbial Commercial Activity Notices (MCANs), Significant New Use Notices (SNUNs), Low-Volume and other Exemptions (Exemptions)

Statistics from June 22, 2016 - June 20, 2017

Total Reviews Completed                                                                                                                                                                                     898
Cases Determined to be Invalid or Incomplete 83
Cases Under Review as of June 20, 2017 425**
Total Cases 1, 406

PMN/MCAN/SNUN Reviews Completed
Allowed to commercialize without restrictions
      - Not likely to present an unreasonable risk – TSCA Section 5(g) notice
87

Allowed to commercialize with restrictions

Possible determinations:

  • Insufficient information – TSCA Section 5(e) order and accompanying SNUR;
  • May present an unreasonable risk – TSCA Section 5(e) order and accompanying SNUR;
  • Exposure-based guidelines apply if production is greater than 100,000 kg/yr–
    TSCA Section 5(e) order requiring testing at a certain production volume [typically no SNUR].
203

Not allowed to commercialize pending development of information

Possible determinations:

  • May present an unreasonable risk – TSCA Section 5(e) order, testing required before commercialization; or
    Insufficient information – TSCA Section 5(e) order, testing required before commercialization
3

Banned

Determination:

Will present an unreasonable risk – TSCA Section 5(f); Section 5(f) order or Section 6(a) rule and accompanying SNUR
0
Cases withdrawn 119

Total PMN/MCAN/SNUN Reviews Completed

412

Low Volume Exemption (LVE) /Low Release and Low Exposure (LoREX) Exemption Reviews Completed
Exemptions Granted                                                                                                                                                                                                     387
Exemptions Denied 99
Total Exemption Reviews Completed 486

Notices of Commencement (NOCs) to Manufacture***
Number of NOCs Received                                                                                                                                                                                            264

Statistics Prior to June 22, 2016

Type of Submission


Number Submitted Since 1979

FY 2016****

FY 2015 FY 2014 FY 2013

New Chemicals Program Activities through June 21, 2016

Premanufacture Notices 40,151 189 589 657 637
Test Marketing Exemption Applications (TMEA) 900 17 15 4 24
Low Volume Exemptions (LVE) 13,267 348 >399 434 399
Low Release/Low Exposure Exemption (LoRex) 107 3 2 6 7
Polymer Exemptions*          
Microbial Commercial Activity Notice (MCAN) 111 5 34 21 14
Significant New Use Notice (SNUN) 56 4 5 13 7
Total** 54,592   1,088 1,135 1,044
Notices of Commencement (NOC)*** 14,206 273 267 395 403
Regulatory Action on PMNs Total Number Issued FY 2016**** FY 2015 FY 2014 FY 2013
Section 5(e) Consent Orders 1,729 19 48 20 30
SNURs following section 5(e),
Consent Orders - parentheses indicate
total is a subset of above
(764) (25) (28) (36) (40)
SNURs following PMN review 1,557 100 131 95 157
PMNs withdrawn in face of action 2,082 14 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
****Program Activities through June 21, 2016

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.

Withdrawals

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