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.

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

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)		 FY25 Q2 FY25 Q3
Jan.
2025		 Feb.
2025		 Mar.
2025		 Apr.
2025		 May
2025		 Jun.
2025
Newly submitted1              
Notices2 91 13 5 10 6    
Applications for Exemptions from Full PMN Review Process3 119 19 10 19 23    
Total 210 32 15 29 29    
Risk Assessments Completed              
Notices2 105 27 16 13 11    
Applications for Exemptions from Full PMN Review Process3 123 13 16 13 39    
Rework Assessments Completed4 85 9 13 8 5    
Total 313 49 45 34 55    
Risk Management Completed5              
Notices2 85 13 10 9 13    
Applications for Exemptions from Full PMN Review Process3 123 15 15 19 20    
Total 208 28 25 28 33    
Consent Orders signed by EPA Awaiting Submitter Signature   5 15 17 9    
Total Cases Under EPA Review by Month 12/1/24 1/1/25 2/1/25 3/1/25 4/1/25 5/1/25
Notices2 409 432 432 427 429 421
Applications for Exemptions from Full PMN Review Process3 134 140 145 139 138 137
Total Cases Under EPA Review 543 572 577 566 567 558

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. 
5Includes consent orders, not-likely determinations, and withdrawals.

PMNs, SNUNs, and MCANs under Review by EPA (as of 5/1/2025 cases total)

  • Total Active Cases: 421
  • Total Active Cases with EPA: 274
  • Total Active Cases with Submitters: 147

There are 421 PMN/SNUN/MCAN cases in the chemical review process; of these, approximately 188 cases are in the risk assessment phase, 86 cases are in the risk management phase, 68 cases are awaiting additional information from the submitter, and 79 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 5/1/2025 cases total)

  • Total Active Cases: 137
  • Total Active Cases with EPA: 109
  • Total Active Cases with Submitters: 28

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 137 LVE/LoREX/TME cases in the chemical review process; of these, approximately 106 cases are in the risk assessment phase, 3 cases are in the risk management phase, and 28 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 784 23 80 42 267 177 79 34 20 40 22
Allowed to commercialize with restrictions pending information development, if applicable 1005 2 271 151 79 92 53 83 86 132 56
Not allowed to commercialize pending development of information;
and prohibited from commercialization		 23 0 6 0 2 1 4 0 0 103 0
Withdrawn 468 10 128 69 54 49 48 30 39 34 7
Total Completed 2280 35 485 262 402 319 184 147 145 216 85
Invalid or Incomplete 157 8 31 30 24 19 17 13 6 8 1

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 May 1, 2025.
3On March 21, 2024, the U.S. Court of Appeals for the Fifth Circuit vacated nine of these ten orders. A link to the vacated orders can be found here.

Exemption Reviews by Fiscal Year

  Total 20161 2017 2018 2019 2020 2021 2022 2023 2024 20252
Granted 1986 64 415 249 288 227 158 156 157 164 108
Denied 359 17 107 5 0 2 36 119 47 15 11
Withdrawn 175 3 33 13 21 12 47 29 2 11 4
Total Completed 2520 84 555 267 309 241 241 304 206 190 123
Invalid or Incomplete 171 13 26 39 19 21 11 17 12 4 9

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 May 1, 2025.
 

Valid Submissions Received by Fiscal Year

Submission Type Total 20161 2017 2018 2019 2020 2021 2022 2023 2024 20252
PMN 2391 454 416 371 178 174 196 192 169 167 74
MCAN 209 29 21 31 19 13 32 28 8 18 10
SNUN 101 10 13 11 5 7 9 9 23 7 7
Notices Total 2701 493 450 413 202 194 237 229 200 192 91
LVE3 2584 269 395 324 279 239 237 278 215 231 117
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 24 0 2 5 0 2 6 0 2 3 4
Tier II 12 3 2 1 0 0 2 2 0 0 2
Exemptions Total 2678 275 414 340 281 248 249 284 225 239 123
Notices of Commencement4 1434 50 289 224 167 190 114 117 85 124 74

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 May 1, 2025.
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 May 2, 2025