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

Statistics for the New Chemicals Review Program under TSCA

The Frank R. Lautenberg Chemical Safety for the 21 Century Act, signed into law on June 22, 2016, was the first substantive reform to TSCA. The law requires EPA to make an affirmative determination on whether a new chemical substance presents an unreasonable risk to human health or the environment under known, intended or reasonably foreseen conditions of use. This page contains information for chemical notices and regulatory actions before and after the date of enactment.

Statistics under Amended TSCA

Since the law’s passage, EPA has completed determinations on 2,314 new chemical cases*. Details on the Agency’s determinations are displayed in the tables below.

EPA will continue to add new content on a regular basis to provide more transparency to the review process for all stakeholders and to allow submitters to readily determine the disposition of their cases. EPA is committed to working with PMN submitters to provide more certainty in the review process and to complete the chemical review process.

*Includes PMN/SNUN/MCAN cases, exemption cases, and withdrawals.

Cases under Review by EPA

There are 396 PMN/SNUN/MCAN cases in the chemical review process; of these, approximately 17 cases are in the risk assessment phase, 149 cases are in the risk characterization phase, 149 cases are awaiting additional information from the submitter, 71 cases are in the regulatory decision and action development stage, and 10 cases are awaiting the submitter signature for an Order.

The graphic below describes the number of active cases (PMNs, SNUNs, MCANs) currently under review by EPA and their stage of review.

Active Cases under Review by EPA (PMN/SNUN/MCAN, as of 8/27/2019, 396 cases total)

^To be updated monthly.

To see a list of case numbers in each stage of the review process, click on the number link in the box for that stage.  This will open a new tab in your browser window.

 

What happens at each stage of the EPA review?

EPA’s new chemicals review process for active cases under review includes six key stages:

Pre-Submission – Companies are encouraged to contact EPA’s new chemicals program to set up a “pre-notice consultation” to discuss their new chemical submission and understand the Agency’s review process. EPA has developed a “Points to Consider When Preparing TSCA New Chemical Notifications” document to assist submitters with the preparation of their submissions. EPA's predictive tools and models are publicly available that are used to estimate releases to the environment, environmental fate, exposures to workers and the general population and hazards. These models and user manuals explain the procedures and provide the default parameters when notices do not provide specific information. Learn more.

Incoming Cases – A pre-screen occurs before risk assessment begins. During this step, submissions are reviewed for administrative completeness and to ensure that all required technical information concerning chemical identity has been submitted. EPA has issued regulations at 40 CFR 720.45 and 40 CFR 720.50 which describe the specific information that must be included in the notice form. EPA will check if the notice is required, is incomplete and/or contains errors pursuant to regulations at 40 CFR 720.62 and 40 CFR 720.65. Failure to include the specific information required by the regulations may result in EPA declaring the submission incomplete and suspending its review. EPA may declare a submission incomplete at any time during the review period where the circumstances warrant doing so under these regulations.

Risk Assessment – EPA conducts a full life-cycle risk assessment of the substance. Chemistry, environmental fate, exposure and hazard (human and ecological) assessments are performed and integrated to determine whether the chemical poses an unreasonable risk to human health or the environment under the conditions of use. The submission is included in the case count in the “Risk Assessment” box during this step.

Risk Characterization – EPA chemical program managers advise submitters of the initial risk assessment findings. Submitters may elect to provide clarifying information to EPA and/or to amend their PMN if risks have been identified in the risk assessment stage.  When this happens, a case may change status from Risk Characterization back to Risk Assessment.  EPA uses any additional information provided by submitters, where appropriate, to revise the initial risk assessment. For example, the initial risk assessment may reflect EPA default assumptions included in exposure models, and the submitter may provide the Agency with refined exposure information based on site specific data.  During this step, the submission is included in the case count in the “Risk Characterization” box if EPA is working on the assessment or is included in the “Awaiting Submitter Information” if EPA is waiting for submitter action.

Awaiting Submitter Information/Action – If EPA is waiting for information for more than 7 days, the submission will be included in the “Awaiting Submitter Information” box. This category includes, but is not limited to, cases for which the submitter is conducting toxicity testing or fate determinations, clarifying manufacturing or processing information, or conducting analytical measurements.

Regulatory Decision and Action Development – EPA makes an affirmative determination on whether the new chemical substance or use is likely to present an unreasonable risk to human health or the environment in the regulatory decision and action development stage. The decision is documented in the risk determination document for "Not likely to Present Unreasonable Risk" or an Order for all other cases.  This determination is made publicly available. The submission is included in the “Regulatory Decision and Action Development” box during this step.  In some instances, submitters may provide additional or clarifying information at this stage that could affect the regulatory decision, and a case may change status from Regulatory Decision and Action Development to Risk Characterization or Risk Assessment.

Awaiting Submitter Signature on Consent Order – EPA generally works with submitters to develop orders that protect human health and the environment and meet the statutory requirements of TSCA. 

Final Determination – EPA posts the final determination in the status tables for section 5 notices reviewed under TSCA.

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 - August 27, 2019

Total Cases 2,920
Total Reviews Completed*                                                                                                                                                                                    2,314
Cases Determined to be Invalid or Incomplete 210
PMN/MCAN/SNUN Cases Under Review as of August 27, 2019 396

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        
378

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.
491

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
8

Prohibited from commercializing

Possible determination:

  • Presents an unreasonable risk – TSCA Section 5(f); Section 5(f) order or proposed Section 6(a) rule
0

Cases withdrawn

  • Submitters may withdraw cases at any time in the review process for a variety of reasons, including in cases
    where regulatory action was indicated 
258

Total PMN/MCAN/SNUN Reviews Completed

1,135

Notices of Commencement (NOCs) to Manufacture**
Number of NOCs Received (6/22/2016 through 8/27/2019)                                                                                                                        718  

Low Volume Exemption (LVE) /Low Release and Low Exposure (LoREX) Exemption Reviews Completed
Exemptions Granted                                                                                                                                                                                                 983
Exemptions Denied 128
Exemptions cases withdrawn 68
Total Exemption Reviews Completed 1,179


* Total reviews completed includes PMN/MCAN/SNUN reviews and LVE/LoRex Exemption reviews.
** 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

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 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.