Modification of Significant New Use Rules of Certain Chemical Substances (23-1.M)

FederalRegulations

Ask Donna

How this section applies to your facts.

Federal Register › Vol. 90 › 90 FR 48717

This text was captured on Aug 14, 2026. It is a snapshot, not a live feed, so check the official code before relying on it.

Text

ENVIRONMENTAL PROTECTION AGENCY 40 CFR Parts 721 and 725 [EPA-HQ-OPPT-2022-0863; FRL-12967-01] RIN 2070-AB27 Modification of Significant New Use Rules of Certain Chemical Substances (23-1.M) AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Proposed rule.

SUMMARY:

EPA is proposing to amend the significant new use rules (SNURs) for certain chemical substances identified herein, which were the subject of one or more premanufacture notices (PMNs), a Microbial Commercial Activity Notice (MCAN) for one substance, and in some cases significant new use notices (SNUNs). This action would amend the SNURs to (1) allow certain new uses reported in the SNUNs or PMNs without additional notification requirements, (2) modify the significant new use notification requirements based on the actions and determinations for the SNUN or PMN submissions or based on the examination of new test data or other information, and (3) make technical amendments to several SNURs. EPA is proposing these amendments based on our review of new and existing data for the chemical substances.

DATES:

Comments must be received on or before November 28, 2025.

ADDRESSES:

Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2022-0863, online at https://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Additional instructions on commenting and visiting the docket, along with more information about dockets generally, is available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT:

For technical information: Brianna Godwin, New Chemicals Division (7405M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: (202) 565-0076; email address: godwin.brianna@epa.gov

re information about dockets generally, is available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT:

For general information on SNURs: William Wysong, New Chemicals Division (7405M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: (202) 564-4163; email address: wysong.william@epa.gov.

For general information on TSCA: The TSCA Assistance Information Service Hotline, Goodwill Vision Enterprises, 422 South Clinton Ave., Rochester, NY 14620; telephone number: (800) 471-7127 or (202) 554-1404; email address: TSCA-Hotline@epa.gov.

SUPPLEMENTARY INFORMATION:

I. Executive Summary

A. What is the Agency's authority for taking this action?

TSCA section 5(a)(2) (15 U.S.C. 2604(a)(2)) authorizes EPA to determine that a use of a chemical substance is a “significant new use.” EPA must make this determination by rule after considering all relevant factors, including the factors in TSCA section 5(a)(2) (see also the discussion in Unit II.). Procedures and criteria for modifying or revoking SNUR requirements appear at 40 CFR 721.185 or 725.984 (for microorganisms).

B. What action is the Agency taking?

EPA is proposing amendments to the SNURs for certain chemical substances in 40 CFR part 721, subpart E and part 725, subpart M (for microorganisms). A SNUR for a chemical substance designates certain activities as a significant new use. Persons who intend to manufacture or process the chemical substance for the significant new use must notify EPA at least 90 days before commencing that activity. The required notification ( i.e., a SNUN) initiates EPA's evaluation of the intended use

extent to which a use changes the type or form of exposure of human beings or the environment to a chemical substance.

• The extent to which a use increases the magnitude and duration of exposure of human beings or the environment to a chemical substance.

• The reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal of a chemical substance.

In determining whether and how to modify EPA's identification of significant new uses for the chemical substances that are the subject of these SNURs, EPA considered the four factors specifically identified in TSCA section 5(a)(2) and relevant information about the toxicity of the chemical substances, and potential human exposures and environmental releases that may be associated with the substances.

B. Rationale and Objectives of the SNURs

1. Rationale

Under TSCA, no person may manufacture a new chemical substance or manufacture or process a chemical substance for a significant new use until EPA makes a determination as described in TSCA section 5(a) and takes any required action. The issuance of a SNUR is not a risk determination itself, only a notification requirement for “significant new uses,” so that the Agency has the opportunity to review the SNUN for the significant new use and make a TSCA section 5(a)(3) risk determination.

In those instances where EPA is proposing to expand the scope of a significant new use or identify an additional significant new use, the Agency identified concerns, as discussed in Unit III.C, associated with certain potential new uses. EPA considered the factors discussed in Unit II.A, and EPA determined that uses of concern could result in changes in the type or form of exposure to the chemical substance, increased exposures to the chemical substance, and/or changes in the reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal of the chemical substance

potential new uses. EPA considered the factors discussed in Unit II.A, and EPA determined that uses of concern could result in changes in the type or form of exposure to the chemical substance, increased exposures to the chemical substance, and/or changes in the reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal of the chemical substance.

In those instances where EPA is proposing to narrow the scope of a significant new use, EPA has (1) received significant new use or premanufacture notices for some of the activities designated as significant new uses of the substance and, after reviewing such notices, concluded that there is no need to require additional notice from persons who propose to engage in identical or similar activities; or (2) received test data or other information that led the Agency to conclude that certain activities designated as significant new uses are not likely to present an unreasonable risk of injury to health or the environment.

2. Objectives

EPA proposes SNURs because the Agency has determined it is appropriate:

• To have an opportunity to review and evaluate data submitted in a SNUN before the submitter begins manufacturing or processing a listed chemical substance for the described significant new use.

• To be obligated to make a determination under TSCA section 5(a)(3) regarding the use described in the SNUN, under the conditions of use. The Agency will either determine under TSCA section 5(a)(3)(C) that the significant new use is not likely to present an unreasonable risk, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant by the Administrator under the conditions of use, or make a determination under TSCA section 5(a)(3)(A) or (B) and take the required regulatory action associated with the determination, before manufacture or processing for the significant new use of the chemical substance can occur

ble risk, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant by the Administrator under the conditions of use, or make a determination under TSCA section 5(a)(3)(A) or (B) and take the required regulatory action associated with the determination, before manufacture or processing for the significant new use of the chemical substance can occur.

Issuance of a SNUR for a chemical substance does not signify that the chemical substance is listed on the TSCA Chemical Substance Inventory (TSCA Inventory). Guidance on how to determine if a chemical substance is on the TSCA Inventory is available at https://www.epa.gov/tsca-inventory.

C. Significant New Uses Claimed as CBI

The SNURs that EPA is proposing to modify include certain significant new uses which have been claimed as CBI subject to Agency confidentiality regulations at 40 CFR part 2 and 40 CFR part 720, subpart E or 40 CFR part 725, subpart C (for microorganisms). Absent a final determination or other

Under these procedures a manufacturer or processor may request EPA to identify the confidential significant new use under the rule. The manufacturer or processor must show that it has a bona fide intent to manufacture or process the chemical substance. If EPA concludes that the person has shown a bona fide intent to manufacture or process the chemical substance, EPA will identify the confidential significant new use to that person. Since some of the specific chemical identities of the chemical substances subject to these SNURs are also CBI, manufacturers and processors may similarly request EPA to determine whether a chemical substance is subject to these SNURs, and can combine the bona fide submission for confidential significant new use and specific chemical identity under the procedure in 40 CFR 721.11 into a single step.

D. Applicability of General Provisions

General provisions for SNURs appear in 40 CFR part 721, subpart A and (for microorganisms) 40 CFR part 725, subpart L

EPA to determine whether a chemical substance is subject to these SNURs, and can combine the bona fide submission for confidential significant new use and specific chemical identity under the procedure in 40 CFR 721.11 into a single step.

D. Applicability of General Provisions

General provisions for SNURs appear in 40 CFR part 721, subpart A and (for microorganisms) 40 CFR part 725, subpart L. These provisions describe persons subject to SNURs, recordkeeping requirements, exemptions to reporting requirements, and applicability of the rule to uses occurring before the effective date of the rule. Pursuant to 40 CFR 721.1(c) or 725.900(b) (for microorganisms), persons subject to SNURs must comply with the same requirements and EPA regulatory procedures as submitters of PMNs (or MCANs) under TSCA section 5(a)(1)(A). In particular, these requirements include the information submission requirements of TSCA sections 5(b) and 5(d)(1), the exemptions authorized by TSCA sections 5(h)(1), 5(h)(2), 5(h)(3), and 5(h)(5) and the regulations at 40 CFR part 720 or part 725 (for microorganisms). In addition, provisions relating to user fees appear at 40 CFR part 700.

Once EPA receives a SNUN, EPA must either determine that the significant new use is not likely to present an unreasonable risk of injury under the conditions of use for the chemical substance or take such regulatory action as is associated with an alternative determination under TSCA section 5 before the manufacture (including import) or processing for the significant new use can commence. If EPA determines that the significant new use of the chemical substance is not likely to present an unreasonable risk, EPA is required under TSCA section 5(g) to make public, and submit for publication in the Federal Register , a statement of EPA's findings

proceed.

F. Important Information About SNUN Submissions

1. SNUN Submissions

SNUNs must be submitted on EPA Form No. 7710-25, generated using e-PMN software, and submitted to the Agency in accordance with the procedures set forth in 40 CFR 720.40 and 721.25. E-PMN software is available electronically at https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca.

2. Development and Submission of Information

EPA recognizes that TSCA section 5 does not require development of any particular new information ( e.g., generating test data) before submission of a SNUN. There is an exception: If a person is required to submit information for a chemical substance pursuant to a rule, order or consent agreement under TSCA section 4, then TSCA section 5(b)(1)(A) requires such information to be submitted to EPA at the time of submission of the SNUN.

In the absence of a rule, TSCA order, or consent agreement under TSCA section 4 covering the chemical substance, persons are required only to submit information in their possession or control and to describe any other information known to or reasonably ascertainable by them (see 40 CFR 720.50 or 40 CFR 725.160 [for microorganisms]). However, upon review of PMNs and SNUNs, the Agency has the authority to require appropriate testing. To assist with EPA's analysis of the SNUN, submitters are encouraged, but not required, to provide the potentially useful information identified for the chemical substance in Unit III.C.

EPA strongly encourages persons, before performing any testing, to consult https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/alternative-test-methods-and-strategies-reduce.

The potentially useful information described in Unit III. may not be the only means of providing information to evaluate the chemical substance associated with the significant new uses. However, submitting a SNUN without any test data may increase the likelihood that EPA will take action under TSCA sections 5(e) or 5(f)

anaging-chemicals-under-tsca/alternative-test-methods-and-strategies-reduce.

SNUN submitters should be aware that EPA will be better able to evaluate SNUNs which provide detailed information on the following:

• Human exposure and environmental release that may result from the significant new use of the chemical substances.

III. Chemical Substances Subject to These Significant New Use Rule Amendments and Proposed Changes

A. What is the designated cutoff date for determining whether the new use is ongoing for these chemical substances?

EPA designates October 28, 2025 as the cutoff date for determining whether the new use is ongoing. This designation is explained in more detail in Unit II.E.

B. What information is provided for each chemical substance?

For each chemical substance identified in Unit III.C., EPA provides the following information:

• CFR citation for the existing SNUR that EPA is proposing to amend.

• PMN (or MCAN) and SNUN number(s), as applicable.

• Chemical name (generic name, if the specific name is claimed as CBI).

• Chemical Abstracts Service Registry Number (CASRN) (if assigned for non-confidential chemical identities).

• Federal Register citation(s) for the previously issued final rules(s).

• Basis for the proposed amendment.

C. Which chemical substances are subject to the proposed amendments?

The substances subject to the proposed amendments presented in this document are as follows:

CFR citation: 40 CFR 721.1725.

PMN and SNUN number(s): P-82-438

amendment: P-05-309 states that the PMN substance will be used as an inkjet ink. Based on test data on the PMN substance and on analogous chemicals, EPA predicted concerns for developmental toxicity, liver toxicity, blood/immune system effects and possibly digestive tract and kidney effects. EPA did not determine that the proposed processing or use of the substance may present an unreasonable risk. EPA did determine, however, that domestic manufacture or use of the substance other than as described in the PMN may cause serious health effects. Based on this information, the PMN substance met the concern criteria at § 721.170(b)(1)(i)(C), (b)(3)(ii), and (b)(4)(ii). On September 19, 2007, EPA issued a SNUR for P-05-309 which included the following significant new uses: domestic manufacture and use other than the use in the PMN.

On January 30, 2013, EPA received SNUN S-13-4 for use as a fixing agent of ink for inkjet printers. EPA determined that the new use will not present an unreasonable risk of injury to human health. The proposed amendment to the SNUR would remove use as a fixing agent of ink for inkjet printers from the scope of the significant new use and would require notification for any uses not listed in the SNUR or PMN.

Potentially useful information: EPA has determined that certain information may be potentially useful if a manufacturer or processor is considering submitting a SNUN for a significant new use designated by this SNUR. EPA has determined that the results of developmental or chronic toxicity testing may be potentially useful to characterize the health effects of the substance.

CFR citation: 40 CFR 721.10471.

PMN and SNUN number(s): P-03-622, SN-17-5, SN-20-7, SN-21-4, SN-23-7.

Chemical name: 2-Propenoic acid, 1,1′-(3-methyl-1,5-pentanediyl) ester.

CASRN: 64194-22-5.

Final rule FR citation(s): September 21, 2012 (77 FR 58698) (FRL-9357-2)

ncentrations that exceed 1 part per billion (ppb);

• Use the substance only as a monomer for use in production of UV curable coatings and printing inks; and

• Manufacture of the substance only by import into the United States ( i.e., no domestic manufacture).

On July 21, 2020, EPA received SNUN SN-20-7 for domestic manufacturing and use as a component of UV curable coatings and printing inks. After review of SN-20-7, information available to EPA indicates that there is a potential for human or environmental exposure to the SNUN substance and that the SNUN substance may present a risk to workers exposed via the dermal route for local dermal effects and skin sensitization, may present a risk to workers exposed via the inhalation route for irritation, sensitization and respiratory effects, and may present risk to aquatic organisms from chronic exposure to the environment based on the chronic COC of 12 ppb being during use. Therefore, EPA determined according to TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I) that the new uses may present an unreasonable risk to human health and that an Order was required to protect against those risks. On September 18, 2023, EPA issued an Order for SN-20-7 under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health and the environment

xicity; irritation to eyes, skin, and respiratory tract; skin sensitization; systemic effects; and developmental effects. Based on physical/chemical properties of the substance, EPA also identified concerns for aspiration hazard. Based on the bifunctional reactive groups (terminal alkenes) indicating potential for protein crosslinking, EPA has also identified concerns for respiratory sensitization. Based on comparison to analogous acrylates and methacrylates, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 12 ppb. On August 16, 2022, EPA issued an Order for SN-21-4 under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health and the environment. The submitter of SN-21-4 is subject to the following Order requirements:

• Use of personal protective equipment where there is a potential for dermal exposure;

• Use of a NIOSH-certified respirator with an APF of at least 50 where there is a potential for inhalation exposure;

• No release of the substance resulting in surface water concentrations that exceed 12 ppb;

• No use of the substance in a consumer product;

• No use of the substance other than for the confidential use listed in the Order; and

• Establishment of a hazard communication program, including human health precautionary statements, on each label and in the SDS.

On January 9, 2023, EPA received SNUN SN-23-7 for use as a component of UV curable coatings and printing inks, manufacturing additive, adhesives, composites, 3D printing, and coating systems. Based on test data on the substance and information provided in the SDS, EPA has identified concerns for acute inhalation toxicity; irritation to eyes, skin, and respiratory tract; skin sensitization; systemic effects; and developmental effects. Based on analogous data, EPA also identified concerns for respiratory effects

entrations that exceed 11 ppb;

• No use of the substance in a consumer product;

• No use of the substance other than for use as a component of UV curable coatings and printing inks, additive manufacturing, adhesives, composites, 3D printing, and coating systems; and

• Establishment of a hazard communication program, including human health precautionary statements on each label and in the SDS.

The proposed amendment to the SNUR would remove domestic manufacture and use of the substance other than as described in PMN P-03-622 (including a confidential use) from the significant new uses, allowing these conditions of use to occur without notification to EPA. The proposed amendment would instead designate the following activities as significant new uses: (1) use without worker personal protective equipment for dermal protection; (2) use without worker PPE of a NIOSH-certified respirator with an APF of at least 50; (3) use of the chemical substance without establishing a hazard communication program; (4) release of the chemical substance to water resulting in surface water concentrations that exceed 11 ppb; (5) manufacture of the chemical substance in any manner that results in inhalation exposure; (6) use other than as a component of UV curable coatings and printing inks, additive manufacturing, adhesives, composites, 3D printing, and coating systems; and (7) use of the chemical substance in a consumer product. Additionally, the amendment would add an exemption from the SNUR requirements when the substance has been completely reacted or cured.

Potentially useful information: EPA has determined that certain information may be potentially useful if a manufacturer or processor is considering submitting a SNUN for a significant new use designated by this SNUR. EPA has determined that the results of aquatic toxicity testing may be potentially useful to characterize the environmental effects of the SNUN substance.

CFR citation: 40 CFR 721.10966.

PMN and SNUN number(s): P-14-260

determined that certain information may be potentially useful if a manufacturer or processor is considering submitting a SNUN for a significant new use designated by this SNUR. EPA has determined that the results of aquatic toxicity testing may be potentially useful to characterize the environmental effects of the SNUN substance.

CFR citation: 40 CFR 721.10966.

PMN and SNUN number(s): P-14-260.

Chemical name: 1-Propene, 2-bromo-3,3,3-trifluoro-.

CASRN: 1514-82-5.

Final rule FR citation(s): September 21, 2017 (82 FR 44093) (FRL-9959-81).

Basis for the proposed amendment: P-14-260 states that the substance will be used as a fire extinguishing agent for: portable extinguishers (onboard aviation and all nonresidential); niche systems (aircraft, normally unoccupied systems, self-contained automatic fire extinguishing systems); and streaming systems for aircraft rescue fire fighting vehicles. Based on test data on the PMN substance, EPA identified concerns for reproductive effects for unprotected workers from repeated inhalation exposures. An Order was issued under TSCA sections 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I), based on a finding that the substance may present an unreasonable risk of injury to human health and the environment. The submitter of P-14-260 was subject to the following Order requirements:

• Manufacture of the substance only by import into the United States ( i.e., no domestic manufacture);

• Use of personal protective equipment including a National Institute for Occupational Safety and Health (NIOSH)-certified respirator with an assigned protection factor (APF) of at least 10 or compliance with a new chemical exposure limit (NCEL) of 1.0 parts per million (ppm) as an 8-hour time-weighted average, when there is a potential for inhalation exposures;

• Establishment and use of a hazard communication program, including human health precautionary statements, on each label and in the Safety Data Sheet (SDS);

• Processing (including filling of hand-held fire extinguishers or fire extinguish

a new chemical exposure limit (NCEL) of 1.0 parts per million (ppm) as an 8-hour time-weighted average, when there is a potential for inhalation exposures;

• Establishment and use of a hazard communication program, including human health precautionary statements, on each label and in the Safety Data Sheet (SDS);

• Processing (including filling of hand-held fire extinguishers or fire extinguishing systems) of the PMN substance only in an enclosed process; and

• Use only as either (1) total flooding agent in unoccupied spaces, specifically engine nacelles and auxiliary power units (APUs) in aircraft; or (2) streaming fire extinguishing agent for use only in handheld extinguishers in aircraft.

On September 21, 2017, EPA issued a SNUR designating significant new uses based on and consistent with the Order requirements.

On April 20, 2018, EPA received a request from the PMN submitter to modify the Order to allow two additional uses: streaming in all non-residential uses (except for commercial home office and personal watercraft), and niche flooding application for unoccupied spaces, such as “not normally occupied volumes” up to 500 ft 3 ( e.g., large data storage rooms). EPA assessed exposures from the proposed new uses and determined that exposures and risk— i.e., acceptable risks, except for filling of canisters, which is controlled under the original Order—from the proposed new uses are the same as for the original uses identified in P-14-260. As a result, EPA modified the Order. Accordingly, the proposed amendment to the SNUR would reduce the scope of the significant new uses to exclude the two additional uses.

Potentially useful information: EPA has determined that certain information may be potentially useful if a manufacturer or processor is considering submitting a SNUN for a significant new use designated by this SNUR. EPA has determined that inhalation monitoring data, collected according to EPA's draft Inhalation

CFR citation: 40 CFR 721.11180.

PMN and SNUN number(s): P-17-283

ditional uses.

Potentially useful information: EPA has determined that certain information may be potentially useful if a manufacturer or processor is considering submitting a SNUN for a significant new use designated by this SNUR. EPA has determined that inhalation monitoring data, collected according to EPA's draft Inhalation

CFR citation: 40 CFR 721.11180.

PMN and SNUN number(s): P-17-283.

Chemical name: Arenesulfonic acid, alkyl derivatives, metal salts (generic).

CASRN: Not Available.

Final rule FR citation(s): December 5, 2019 (84 FR 66596) (FRL-10001-47).

Basis for the proposed amendment: P-17-283 states that the substance will be used as a lubricating oil additive for automotive engine oils. Based on analysis of test data on the substance, EPA identified a concern for corrosion to skin, eyes, mucous membranes, and lungs. There are also concerns for surfactant effects on the lung based on surfactant properties of the compounds and for acute toxicity, mutagenicity, irritation, and sensitization based on submitted analogue test data. An Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health and the environment. The Order was also issued under TSCA sections 5(a)(3)(B)(ii)(II) and 5(e)(1)(A)(ii)(II), based on a finding that the substance is or will be produced in substantial quantities and that the substance either enters or may reasonably be anticipated to enter the environment in substantial quantities, or there is or may be significant (or substantial) human exposure to the substance

onal OMB approval. If an entity were to submit a SNUN to the Agency, the annual burden is estimated to average between 30 and 170 hours per submission. This burden estimate includes the time needed to review instructions, search existing data sources, gather and maintain the data needed, and complete, review, and submit the required SNUN.

EPA always welcomes your feedback on the burden estimates. When submitting comments on these proposed SNURs, include comments about the accuracy of the burden estimate, and any suggested methods for improving the collection instruments or instruction or minimizing respondent burden, including through the use of automated collection techniques.

D. Regulatory Flexibility Act (RFA)

I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA (5 U.S.C. 601 et seq. ). The requirement to submit a SNUN applies to any person (including small or large entities) who intends to engage in any activity described in the final rule as a “significant new use.” Because these uses are “new,” based on all information currently available to EPA, EPA has concluded that no small or

A SNUR requires that any person who intends to engage in such activity in the future must first notify EPA by submitting a SNUN. Although some small entities may decide to pursue a significant new use in the future, EPA cannot presently determine how many, if any, there may be. However, EPA's experience to date is that, in response to the promulgation of SNURs covering over 1,000 chemicals, the Agency receives only a small number of notices per year. For example, the number of SNUNs received was 9 in fiscal year FY2022, 23 in FY2023, and 7 in FY2024, and only a fraction of these submissions was from small businesses.

In addition, the Agency currently offers relief to qualifying small businesses by reducing the SNUN submission fee from $37,000 to $6,480

overing over 1,000 chemicals, the Agency receives only a small number of notices per year. For example, the number of SNUNs received was 9 in fiscal year FY2022, 23 in FY2023, and 7 in FY2024, and only a fraction of these submissions was from small businesses.

In addition, the Agency currently offers relief to qualifying small businesses by reducing the SNUN submission fee from $37,000 to $6,480. This lower fee reduces the total reporting and recordkeeping cost of submitting a SNUN to about $14,500 per SNUN submission for qualifying small firms. Therefore, the potential economic impacts of complying with these proposed SNURs are not expected to be significant or adversely impact a substantial number of small entities. In a SNUR that published in the Federal Register of June 2, 1997 (62 FR 29684) (FRL-5597-1), the Agency presented its general determination that SNURs are not expected to have a significant economic impact on a substantial number of small entities, which was provided to the Chief Counsel for Advocacy of the Small Business Administration.

E. Unfunded Mandates Reform Act (UMRA)

This action does not contain an unfunded mandate of $100 million or more (in 1995 dollars) in any one year as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. Based on EPA's experience with proposing and finalizing SNURs, State, local, and Tribal governments have not been impacted by SNURs, and EPA does not have any reasons to believe that any State, local, or Tribal government will be impacted by these SNURs. In addition, the estimated costs of this action to the private sector do not exceed $183 million or more in any one year (the 1995 dollars are adjusted to 2023 dollars for inflation using the GDP implicit price deflator). The estimated costs for this action are discussed in Unit I.D.

es not have any reasons to believe that any State, local, or Tribal government will be impacted by these SNURs. In addition, the estimated costs of this action to the private sector do not exceed $183 million or more in any one year (the 1995 dollars are adjusted to 2023 dollars for inflation using the GDP implicit price deflator). The estimated costs for this action are discussed in Unit I.D.

F. Executive Order 13132: Federalism

This action will not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999), because it is not expected to have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, the requirements of Executive Order 13132 do not apply to this action.

G. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments

This action will not have Tribal implications as specified in Executive Order 13175 (65 FR 67249, November 9, 2000), because it is not expected to have substantial direct effects on Indian Tribes, significantly or uniquely affect the communities of Indian Tribal governments and does not involve or impose any requirements that affect Indian Tribes. Accordingly, the requirements of Executive Order 13175 do not apply to this action.

H. Executive Order 13045: Protection of Children From Environmental Health Risks and Safety Risks

175 do not apply to this action.

H. Executive Order 13045: Protection of Children From Environmental Health Risks and Safety Risks

This action is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997), because it does not concern an environmental health or safety risk. Since this action does not concern a human health risk, EPA's 2021 Policy on Children's Health also does not apply. Although the establishment of these SNURs do not address an existing children's environmental health concern because the chemical uses involved are not ongoing uses, SNURs require that persons notify EPA at least 90 days before commencing manufacture (defined by statute to include import) or processing of the identified chemical substances for an activity that is designated as a significant new use by the SNUR. This notification allows EPA to assess the intended uses to identify potential risks and take appropriate actions before the activities commence.

I. Executive Order 13211: Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use

This action is not a “significant energy action” as defined in Executive Order 13211 (66 FR 28355, May 22, 2001), because it is not likely to have a significant adverse effect on the supply, distribution, or use of energy.

J. National Technology Transfer and Advancement Act (NTTAA)

This action does not involve any technical standards subject to NTTAA section 12(d) (15 U.S.C. 272 note).

List of Subjects in 40 CFR Part 721 and 725

Environmental protection, Chemicals, Hazardous substances, Reporting and recordkeeping requirements.

Dated: October 21, 2025. Mary Elissa Reaves, Director, Office of Pollution Prevention and Toxics.

For the reasons stated in the preamble, EPA proposes to amend 40 CFR chapter I as follows:

PART 721—SIGNIFICANT NEW USES OF CHEMICAL SUBSTANCES

1. The authority citation for part 721 continues to read as follows:

Authority:

15 U.S.C. 2604, 2607, and 2625(c).

rdkeeping requirements.

Dated: October 21, 2025. Mary Elissa Reaves, Director, Office of Pollution Prevention and Toxics.

For the reasons stated in the preamble, EPA proposes to amend 40 CFR chapter I as follows:

PART 721—SIGNIFICANT NEW USES OF CHEMICAL SUBSTANCES

1. The authority citation for part 721 continues to read as follows:

Authority:

15 U.S.C. 2604, 2607, and 2625(c).

2. Amend § 721.1725 by revising paragraph (b) to read as follows:

§ 721.1725 Benzoic acid, 3,3′-methylenebis [6-amino-, di-2-propenyl ester. (a) * * *

(1) * * *

(2) * * *

(b) * * *

(1) Determining whether a specific use is subject to this rule. The provisions of § 721.11 apply to paragraph (a)(1) of this section and to chemical substances which are subject to a significant new use rule in subpart E of this part.

(2) * * *

3. Amend § 721.2076 by revising paragraph (a)(1) to read as follows:

§ 721.2076 D-Glucuronic acid, polymer with 6-deoxy-L-mannose and D-glucose, acetate, calcium magnesium potassium sodium salt. (a) * * *

(1) The chemical substance identified as D-glucuronic acid, polymer with 6-deoxy-L-mannose and D-glucose, acetate, calcium magnesium potassium sodium salt (PMN P-00-7; SNUNs S-05-1, S-06-4, S-07-03, and S-07-5; CAS No. 595585-15-2) is subject to reporting under this section for the significant new use described in paragraph (a)(2) of this section.

(2) * * *

(i) * * *

(ii) * * *

(b) * * *

(1) * * *

(2) * * *

4. Amend § 721.10070 by revising paragraphs (a)(1) and (a)(2)(i) to read as follows:

§ 721.10070 1,3-Butanediol, 3-methyl-. (a) * * *

(1) The chemical substance identified as 1,3-butanediol, 3-methyl- (PMN P-05-309; SNUN S-13-4; CAS No. 2568-33-4) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) * * *

.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures ( e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible. For purposes of § 721.63(a)(5), respirators must provide a National Institute for Occupational Safety and Health (NIOSH) assigned protection factor (APF) of at least 50.

(ii) Hazard communication. Requirements as specified in § 721.72(a) through (d), (f), (g)(1), (3)(iii), and (5). For purposes of § 721.72(g)(1), this substance may cause: acute toxicity (inhalation only), skin irritation, eye irritation, respiratory sensitization, skin sensitization, specific target organ toxicity, and aspiration hazard. Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.

(iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(o). It is a significant new use to manufacture the substance in any manner that results in inhalation exposure to the substance. It is a significant new use to use the substance other than as a component of UV curable coatings and printing inks, additive manufacturing, adhesives, composites, 3D printing, and coating systems.

(iv) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4) where N=11.

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (i) and (k) are applicable to manufacturers (including importers) and processors of this substance.

(2) Limitation or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

6. Amend § 721.10966 by revising paragraphs (a)(2)(iii) to read as follows:

§ 721.10966 1-Propene, 2-bromo-3,3,3-trifluoro-. (a) * * *

(1) * * *

(2) * * *

125(a) through (i) and (k) are applicable to manufacturers (including importers) and processors of this substance.

(2) Limitation or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

6. Amend § 721.10966 by revising paragraphs (a)(2)(iii) to read as follows:

§ 721.10966 1-Propene, 2-bromo-3,3,3-trifluoro-. (a) * * *

(1) * * *

(2) * * *

(i) * * *

(A) * * *

(1) * * *

(2) * * *

(3) * * *

(4) * * *

(5) * * *

(B) * * *

(ii) * * *

(iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(c) and (f). It is a significant new use to use the substance other than as a fire extinguishing agent as a total flooding agent in unoccupied spaces, specifically engine nacelles and auxiliary power units (APUs) in aircraft; as a streaming fire extinguishing agent for use only in handheld extinguishers in aircraft; streaming in all non-residential uses, except for commercial home office and personal watercraft; or niche flooding application for unoccupied spaces, such as “not normally occupied volumes” up to 500 ft 3 ( e.g., large data storage rooms).

(b) * * *

(1) * * *

(2) * * *

7. Amend § 721.11180 by revising paragraph (a)(2)(iii) to read as follows:

§ 721.11180 Arenesulfonic acid, alkyl derivatives, metal salts (generic). (a) * * *

(1) * * *

(2) * * *

(i) * * *

(ii) * * *

(iii) Industrial, commercial, and consumer activities. It is a significant new use to manufacture, process, or use the substance in any manner that results in the generation of a vapor, mist, spray, or aerosol.

(b) * * *

(1) * * *

(2) * * *

PART 725—SIGNIFICANT NEW USES OF MICROORGANISMS

8. The authority citation for part 725 continues to read as follows:

Authority:

15 U.S.C. 2604, 2607, 2613, and 2625.

9. Amend § 725.1080 by revising paragraphs (b)(1) and (2) to read as follows:

§ 725.1080 Trichoderma reesei (generic). (a) * * *

(1) * * *

(2) * * *

(i) * * *

(ii) * * *

This is a copy of a public record, reproduced as it was published. It is not legal advice, and it may not be the version a court would rely on. Check the official source before you cite it.