Statistics for the New Chemicals Program under TSCA

The Toxic Substances Control Act (TSCA) requires EPA to review the potential risks of new chemicals before they enter the U.S. market and, when necessary, put safeguards in place to protect human health and the environment from any risks. Learn more about EPA’s review process for new chemicals.

This webpage provides a general overview of EPA’s new chemicals workload, tracks the status of active cases currently under review by EPA, and illustrates general statistics for all new chemical submissions received since TSCA was amended on June 22, 2016. You can also view statistics related to new chemical submissions prior to the 2016 TSCA reauthorization, New Chemical Program Statistics Prior to June 22, 2016.

Prior to the 2016 amendments to TSCA, EPA issued risk determinations for approximately 20% of new chemical submissions. In 80% of cases, EPA “dropped” the chemical from further review and allowed it to go to market. Following the 2016 amendments to TSCA, EPA is required to make an affirmative risk determination on 100% of new chemical notices submitted under TSCA section 5. Because EPA only made determinations on around 20% of submissions under the pre-2016 law, the amendments resulted in an approximate 5-fold increase in workload for the agency.

Despite the increase in workload, the TSCA new chemicals program has been operating with insufficient resources to meet all the requirements under the amended law. To maximize the impacts of its limited resources, EPA takes into account a variety of factors in prioritizing new chemical submissions for review including:

  • The date of receipt of submission (e.g., EPA generally strives for a first-in-first-out approach, absent extenuating circumstances)
  • Statutory and regulatory deadlines
  • The extent to which the submitter has provided additional information DURING the review period – subsequent to the original submission - and the level of effort needed to potentially rework some or all of the risk assessment as a result
  • Consideration of whether the submission is for a chemical used in a sector supported by the Inflation Reduction Act’s climate goals.

In the last few years, EPA has received an average of about 500 TSCA section 5 notices and other applications each year. This includes premanufacture notices (PMNs), significant new use notices (SNUNs), and microbial commercial activity notices (MCANs) – all of which must be reviewed within 90 days. EPA’s total new chemicals workload also includes applications for exemptions from the full PMN review process (e.g., low volume (LVE), low release and low exposures (LoREX), test market (TME), etc.). These applications represent over 50% of annual applications, have between 30- and 60-day review periods, and are also reviewed by EPA using a robust risk assessment process. EPA review may indicate that an exemption can be granted only if the submitter amends the exemption request to include certain additional limitations on processing, use or disposal.  Grants for LVEs only apply to the LVE submitter, any other manufacturer is required to send a new chemical notice before manufacture.

Current Fiscal Year – Cases Completed by Month

TSCA Section 5 Submissions - Monthly Statistics
  FY25 Total
(to date)		 FY24 Q4 FY25 Q1
July
2024		 Aug.
2024		 Sept.
2024		 Oct.
2024		 Nov.
2024		 Dec.
2024
Newly submitted1  
Notices2 13 12 8 6 13    
Applications for Exemptions from Full PMN Review Process3 14 19 13 10 14    
Total 27 31 21 16 27    
Risk Assessments Completed  
Notices2 15 13 16 21 15    
Applications for Exemptions from Full PMN Review Process3 17 7 11 21 17    
Rework Assessments Completed4 10 2 5 7 10    
Total5 42 22 32 49 42    
Risk Management Completed6  
Notices2 18 35 16 13 18    
Applications for Exemptions from Full PMN Review Process3 23 18 14 17 23    
Total 41 53 30 30 41    
Consent Orders signed by EPA Awaiting Submitter Signature   13 12 16 8    
Total Cases Under EPA Review by Month 6/1/24 7/1/24 8/1/24 9/1/24 10/1/24 11/1/24
Notices2 444 447 424 421 415 411
Applications for Exemptions from Full PMN Review Process3 139 147 148 147 144 135
Total Cases Under EPA Review 583 594 572 568 559 546

1Monthly newly submitted case counts include cases that are deemed valid by the 1st of the following month. Additional submissions may subsequently be deemed valid, invalid, or incomplete during EPA’s prescreening and new chemical review process. Final totals of valid submissions received by fiscal year are provided in the “Valid Submissions Received by Fiscal Year” table on this webpage.
2Premanufacture (PMNs), significant new use (SNUNs), and microbial activity notices (MCANs).
3Low volume (LVEs), low release and exposures (LoREXs) (and modifications), and test market (TMEs); and TSCA environmental release application (TERA), and Tier 2 biotech exemptions.
4In June 2024, EPA started reporting  the number of rework assessments completed monthly beginning with January 2024 . Rework includes work that supplements completed initial risk assessments, e.g., evaluation of new information from the submitter and/or development of new assessment reports or memos in response to new information or questions. 
5Totals for Jan.- October 2024 have been updated to include Rework Assessments Completed.
6Includes consent orders, not-likely determinations, and withdrawals.

PMNs, SNUNs, and MCANs under Review by EPA (as of 11/1/2024 cases total)

  • Total Active Cases: 411
  • Total Active Cases with EPA: 320
  • Total Active Cases with Submitters: 91

There are 411 PMN/SNUN/MCAN cases in the chemical review process; of these, approximately 224 cases are in the risk assessment phase, 96 cases are in the risk management phase, 33 cases are awaiting additional information from the submitter, and 58 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.

 

LVEs, LoREXs, and TMEs under Review by EPA (as of 11/1/2024 cases total)

  • Total Active Cases: 135
  • Total Active Cases with EPA: 106
  • Total Active Cases with Submitters: 29

Under TSCA section 5(h)(4), EPA may, upon application and by rule, exempt a manufacturer of a new chemical substance from the standard PMN review process described under section 5 of TSCA  if the agency determines that the chemical will not present an unreasonable risk. EPA has established such regulations for a variety of circumstances. For example, under the LVE regulations at 40 Code of Federal Regulations (CFR) 723, EPA may grant an entity’s application to manufacture new chemicals produced at low volumes (production volume 10,000 kg/year or less) if EPA determines the new chemical will not present unreasonable risk. More information on exemption applications is available here.

There are 135 LVE/LoREX/TME cases in the chemical review process; of these, approximately 106 cases are in the risk assessment phase, 0 cases are in the risk management phase, and 29 cases are awaiting additional information from the submitter.

The graphic below describes the number of active cases (LVE/LoREX/TME) currently under review by EPA and their stage of review.

To see information about a specific case, look up the case number in the exemptions table here.

 


PMN/MCAN/SNUN Reviews by Fiscal Year

TSCA requires EPA to review submitters' Section 5 notices and make an affirmative finding on the safety of new chemical substances or significant new uses of chemicals (identified by EPA in rulemaking; Significant New Use Rule (SNUR))) submitted under section 5(a) of TSCA before they can proceed to the marketplace.  The law sets forth five possible determinations under Section 5 with related actions and these determinations can be broken up into three categories, including:
Allowed to commercialize without restrictions:

  • Not likely to present an unreasonable risk – TSCA Section 5(g) notice and, if applicable, accompanying SNUR

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;
  • Substantial production/exposure – TSCA Section 5(e) order; and
  • Presents an unreasonable risk -TSCA Section 5(f) order and accompanying SNUR.

Not allowed to commercialize pending development of information; and prohibited from commercialization:

Possible determinations:

  • May present an unreasonable risk – TSCA Section 5(e) order, testing required before commercialization; 
  • Insufficient information – TSCA Section 5(e) order, testing required before commercialization; and
  • Presents an unreasonable risk – TSCA Section 5(f) order or Section 6(a) rule.

The types of determinations made by EPA per fiscal year for Section 5 notices are provided in the table below.

  Total 20161 2017 2018 2019 2020 2021 2022 2023 2024 20252
Allowed to commercialize without restrictions 762 23 80 42 267 177 79 34 20 40 0
Allowed to commercialize with restrictions pending information development, if applicable 965 2 271 151 79 92 53 83 86 131 17
Not allowed to commercialize pending development of information;
and prohibited from commercialization		 23 0 6 0 2 1 4 0 0 10 0
Withdrawn 462 10 128 69 54 49 48 30 39 34 1
Total Completed 2212 35 485 262 402 319 184 147 145 215 18
Invalid or Incomplete 156 8 31 30 24 19 17 13 6 8 0

1Fiscal Year 2016 includes the cases in house at and after the time the Lautenberg Amendments to TSCA were passed but does not include the cases completed prior to the time the Lautenberg Amendments to TSCA were passed (June 22, 2016).
2As of November 1, 2024.

Exemption Reviews by Fiscal Year

  Total 20161 2017 2018 2019 2020 2021 2022 2023 2024 20252
Granted 1898 64 415 249 288 227 158 156 157 164 20
Denied 350 17 107 5 0 2 36 119 47 15 2
Withdrawn 172 3 33 13 21 12 47 29 2 11 1
Total Completed 2419 84 555 267 309 241 241 304 206 190 23
Invalid   
or Incomplete		 162 13 26 39 19 21 11 17 12 4 0

1Fiscal Year 2016 includes the cases in house at and after the time the Lautenberg Amendments to TSCA were passed but does not include the cases completed prior to the time the Lautenberg Amendments to TSCA were passed (June 22, 2016).
2As of November 1, 2024.
 

Valid Submissions Received by Fiscal Year

Submission Type Total 20161 2017 2018 2019 2020 2021 2022 2023 2024 20252
PMN 2329 454 416 371 178 174 196 192 169 167 12
MCAN 199 29 21 31 19 13 32 28 8 18 0
SNUN 95 10 13 11 5 7 9 9 23 7 1
Notices Total 2623 493 450 413 202 194 237 229 200 192 13
LVE3 2484 269 395 324 279 239 237 278 215 234 14
LoREX3 27 2 1 6 1 6 1 1 6 3 0
TME 18 1 12 3 0 0 0 1 0 1 0
TERA 13 0 2 1 1 1 3 2 2 1 0
Tier I 21 0 2 5 0 2 6 0 2 3 1
Tier II 10 3 2 1 0 0 2 2 0 0 0
Exemptions Total 2573 275 414 340 281 248 249 284 225 242 15
Notices of Commencement4 1374 50 289 224 167 190 114 117 85 124 14

1Fiscal Year 2016 includes the cases in house at and after the time the Lautenberg Amendments to TSCA were passed but does not include the cases completed prior to the time the Lautenberg Amendments to TSCA were passed (June 22, 2016).
2As of November 1, 2024.
3Includes Modifications of prior LVE & LoREX exemption notices.
4The number of Notices of Commencement to manufacture or import (NOCs) received during the listed Fiscal Year.
Note: the PMNs for which notices were received in one Fiscal Year were not necessarily reviewed by EPA in that Fiscal Year.

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Last updated on November 5, 2024