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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 has successfully addressed the backlog of manufacturers’ new chemical requests or pre-manufacturing notices (PMNs) under review by the Agency so that the number of cases under review is back to historically typical levels. To achieve this, EPA deployed new staff and made other process changes to make the process faster and more efficient, while ensuring chemical safety. 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. With the new law's passage cases in the review pipeline on June 22, 2016 needed to be reassessed under the new statutory requirements, adding to the Agency’s average case load and creating a “backlog” which grew to almost 600 cases.

The current caseload of cases includes a number of cases in which submitters are developing information or conducting testing. If these cases are subtracted from the total, the number of new chemicals cases under active review by EPA is now consistent with the normal active workload of  cases for the new chemicals review program.

Overall, since the law’s passage, EPA has completed determinations on 1,731 new chemical cases. Details on the Agency’s determinations are displayed below. EPA will continue to add new content, on a weekly basis, 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

Backlog Progression Chart Backlog Progression Chart

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 - October 30, 2018

Total Cases 2,405
Total Reviews Completed                                                                                                                                                                                     1,731
Cases Determined to be Invalid or Incomplete 106
Cases Under Review as of October 30, 2018 568*

PMN/MCAN/SNUN Reviews Completed
Allowed to commercialize without restrictions
      - Not likely to present an unreasonable risk – TSCA Section 5(g) notice and, if applicable, accompanying SNUR
168

Allowed to commercialize with restrictions pending information development, if applicable

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];
  • Presents an unreasonable risk -TSCA Section 5(f) order and accompanying SNUR.
436

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
6

Banned

Determination:

  • Presents an unreasonable risk – TSCA Section 5(f); Section 5(f) order and accompanying SNUR or Section 6(a) rule
0
Cases withdrawn 213

Total PMN/MCAN/SNUN Reviews Completed

823

Low Volume Exemption (LVE) /Low Release and Low Exposure (LoREX) Exemption Reviews Completed
Exemptions Granted                                                                                                                                                                                                     737
Exemptions Denied 128
Exemptions cases withdrawn 43
Total Exemption Reviews Completed 908

Notices of Commencement (NOCs) to Manufacture**
Number of NOCs Received                                                                                                                                                                                            558

* The typical caseload under review is approximately 300 cases.
** Frequently, when a company is allowed to commercialize (with or without restrictions) the company does not immediately begin to manufacture.
When manufacture does commence, the submitter must provide a Notice of Commencement of Manufacture or Import Form (NOC) to EPA within 30 calendar days of the date
when the substance is first manufactured or imported for nonexempt commercial purposes.

Statistics Prior to June 22, 2016

Type of Submission


Number Submitted Since 1979

Through
June 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 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

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.