Significant New Use Rules on Certain Chemical Substances (26-1)
EPA is proposing significant new use rules (SNURs) under the Toxic Substances Control Act (TSCA) for certain chemical substances that were the subject of premanufacture notices ...
EPA is proposing significant new use rules (SNURs) under the Toxic Substances Control Act (TSCA) for certain chemical substances that were the subject of premanufacture notices (PMNs) and are also subject to an Order issued by EPA pursuant to TSCA. The SNURs require persons who intend to manufacture (defined by statute to include import) or process any of these chemical substances for an activity that is proposed as a significant new use by this rulemaking to notify EPA at least 90 days before commencing that activity. The required notification initiates EPA's evaluation of the conditions of that use for that chemical substance. In addition, the manufacture or processing for the significant new use may not commence until EPA has conducted a review of the required notification, made an appropriate determination regarding that notification, and taken such actions as required by that determination.
DATES:
Comments must be received on or before July 10, 2026.
ADDRESSES:
Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2026-0499, 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:
Jordan Garbin, New Chemicals Division (7405M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: (202) 564-4156; email address:
garbin.jordan@epa.gov.
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 of the Finger Lakes, 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.).
B. What action is the Agency taking?
EPA is proposing SNURs for the chemical substances discussed in Unit III. These SNURs, if finalized as proposed, would require persons who intend to manufacture or process any of these chemical substances for an activity that is designated as a significant new use to notify EPA at least 90 days before commencing that activity.
C. Does this action apply to me?
1. General Applicability
This action applies to you if you manufacture, process, or use the chemical substances contained in this proposed rule. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:
Manufacturers or processors of one or more subject chemical substances (NAICS codes 325 and 324110),e.g.,
chemical manufacturing and petroleum refineries.
Chemical importers are subject to TSCA section 13 (15 U.S.C. 2612), the requirements in 19 CFR 12.118 through 12.127, 19 CFR 127.28, and 40 CFR 707.20. Importers of chemical substances in bulk form, as part of a mixture, or as part of an article (if required by rule) must certify that the shipment of the chemical substance complies with all applicable rules and Orders under TSCA, including regulations issued under TSCA sections 5, 6, 7 and Title IV.
Pursuant to 40 CFR 721.20, any persons who export or intend to export a chemical substance that is the subject of this proposed rule on or after July 10, 2026 are subject to TSCA section 12(b) (15 U.S.C. 2611(b)) and must comply with the export notification requirements in 40 CFR part 707, subpart D.
D. What are the incremental economic impacts of this action?
EPA has evaluated the potential costs of establishing Significant New Use Notice (SNUN) reporting requirements for potential manufacturers (including importers) and processors of the chemical substances subject to these proposed SNURs. This analysis, which is available in the docket, is briefly summarized here.
1. Estimated Costs for SNUN Submissions
If a SNUN is submitted, costs are an estimated $45,496 per SNUN submission for large business submitters and $14,976 for small business submitters. These estimates include the cost to prepare and submit the SNUN (including registration for EPA's Central
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Data Exchange (CDX)), and the payment of a user fee. Businesses that submit a SNUN would be subject to either a $37,000 user fee required by 40 CFR 700.45(c)(2)(ii) and (d), or, if they are a small business as defined at 13 CFR 121.201, a reduced user fee of $6,480 (40 CFR 700.45(c)(1)(ii) and (d)). The costs of submission for SNUNs will not be incurred by any company unless a company decides to pursue a significant new use as defined in these SNURs. Additionally, these estimates reflect the costs and fees as they are known at the time of this rulemaking.
2. Estimated Costs for Export Notifications
EPA has also evaluated the potential costs associated with the export notification requirements under TSCA section 12(b) and the implementing regulations at 40 CFR part 707, subpart D. For persons exporting a substance that is the subject of a SNUR, a one-time notice to EPA must be provided for the first export or intended export to a particular country. The total costs of export notification will vary by chemical, depending on the number of required notifications (
i.e.,
the number of countries to which the chemical is exported). While EPA is unable to make any estimate of the likely number of export notifications for the chemical substances covered by these SNURs, as stated in the accompanying economic analysis, the estimated cost of the export notification requirement on a per-unit basis is approximately $106.
E. What should I consider as I prepare my comments for EPA?
TSCA section 5(a)(2) states that EPA's determination that a use of a chemical substance is a significant new use must be made after consideration of all relevant factors, including:
The projected volume of manufacturing and processing of a chemical substance.
The 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 what would constitute a significant new use for the chemical substances that are the subject of these SNURs, EPA considered relevant information about the toxicity of the chemical substances, and potential human exposures and environmental releases that may be associated with the substances, in the context of the four bulleted TSCA section 5(a)(2) factors listed in this Unit and discussed in Unit III.
These proposed SNURs are based on Orders issued to certain companies for substances that were the subject of PMN submissions. Those Orders were issued under TSCA section 5(e)(1)(A), as required by the determinations made under TSCA section 5(a)(3)(B). The TSCA Orders require protective measures to limit exposures or otherwise mitigate the potential unreasonable risk. The proposed SNURs extend those protective measures to any person intending to manufacture, process, use, distribute in commerce, or dispose of the new chemical substances subject to Orders and identify as significant new uses any manufacturing, processing, use, distribution in commerce, or disposal that does not conform to the restrictions imposed by the underlying TSCA Orders, consistent with TSCA section 5(f)(4).
B. Rationale and Objectives of the SNURs
1. Rationale
Under TSCA section 5(a)(1)(B), 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)(3) 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.
During review of the PMNs submitted that identify chemical substances subject to these proposed SNURs, EPA concluded that regulation was warranted under TSCA section 5(e), pending the development of information sufficient to make reasoned evaluations of the health or environmental effects of the chemical substances. Based on the findings outlined in Unit III., TSCA section 5(e) Orders requiring the use of appropriate exposure controls were negotiated with the PMN submitters. As a general matter, EPA believes it is necessary to follow a TSCA Order with a SNUR that identifies the absence of those protective measures as significant new uses to ensure that all manufacturers and processors, not just the party subject to a TSCA Order, are held to the same standard.
2. Objectives
EPA is proposing these SNURs because the Agency has determined it is appropriate:
To identify as significant new uses any manufacturing, processing, use, distribution in commerce, or disposal that does not conform to the restrictions imposed by the underlying TSCA Orders, consistent with TSCA section 5(f)(4).
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.
Issuance of a proposed 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
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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
EPA is proposing to establish certain significant new uses which have been claimed as CBI subject to Agency confidentiality regulations at 40 CFR parts 2 and 703. Absent a final determination or other disposition of the confidentiality claim under these regulations, EPA is required to keep this information confidential. EPA promulgated a procedure at 40 CFR 721.11 to deal with the situation where a specific significant new use is CBI. Under these procedures, a manufacturer or processor may ask EPA to identify the confidential significant new use subject to the SNUR. 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 most of the chemical identities of the chemical substances subject to these SNURs are also CBI, manufacturers and processors can combine the
bona fide
submission 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. 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), persons subject to SNURs must comply with the same requirements and EPA regulatory procedures as submitters of PMNs 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. 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.
As discussed in Unit I.C.2., persons who export or intend to export a chemical substance identified in a proposed or final SNUR are subject to the export notification provisions of TSCA section 12(b), and persons who import a chemical substance identified in a final SNUR are subject to the TSCA section 13 import certification requirements. See also
https://www.epa.gov/tsca-import-export-requirements.
E. Applicability of the Proposed SNURs to Uses Occurring Before the Effective Date of the Final Rule
To establish a significant new use, EPA must determine that the use is not ongoing. The chemical substances subject to this proposed rule have undergone premanufacture review and received determinations under TSCA section 5(a)(3)(C). TSCA Orders have been issued for these chemical substances and the PMN submitters are required by the TSCA Orders to submit a SNUN before undertaking activities that would be designated as significant new uses in these SNURs. Additionally, the identities of many of the chemical substances subject to this proposed rule have been claimed as confidential per 40 CFR 720.85, further reducing the likelihood that another party would manufacture or process the substances for an activity that would be designated as a significant new use. Based on this, the Agency believes that it is highly unlikely that any of the significant new uses identified in Unit III. are ongoing.
When the chemical substances identified in Unit III. are added to the TSCA Inventory, EPA recognizes that, before the rule is effective, other persons might engage in a use that has been identified as a significant new use. Persons who begin manufacture or processing of the chemical substances for a significant new use identified on or after the designated cutoff date specified in Unit III.A. would have to cease any such activity upon the effective date of the final rule. To resume their activities, these persons would have to first comply with all applicable SNUR notification requirements and EPA would have to take action under TSCA section 5 allowing manufacture or processing to proceed.
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). 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 as identified for the chemical substance in Unit III.C.
EPA strongly encourages persons, before performing any testing, to consult with the Agency pertaining to protocol selection. Furthermore, pursuant to TSCA section 4(h), which pertains to reduction of testing in vertebrate animals, EPA encourages consultation with the Agency on the use of alternative test methods and strategies (also called New Approach Methodologies, or NAMs), if available, to generate the recommended test data. EPA encourages dialog with Agency representatives to help determine how best the submitter can meet both the data needs and the objective of TSCA section 4(h). For more information on alternative test methods and strategies to reduce vertebrate animal testing, visit
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
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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). EPA recommends that potential SNUN submitters contact EPA early enough so that they will be able to conduct the appropriate tests.
SNUN submitters should be aware that EPA will be better able to evaluate SNUNs that provide detailed information about human exposure and environmental release that may result from the significant new use of the chemical substances.
III. Chemical Substances Subject to These Proposed SNURs
A. What is the designated cutoff date for ongoing uses?
EPA designates Error! Reference source not found. June 10, 2026 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:
PMN number (the proposed CFR citation assigned in the regulatory text section of this document).
Chemical name (generic name, if the specific name is claimed as CBI).
Chemical Abstracts Service Registry Number (CASRN) or Accession Number (if assigned for confidential chemical identities).
Basis for the SNUR (e.g.,
effective date of and basis for the corresponding TSCA Order).
Potentially useful information.
The regulatory text section of the proposed rule specifies the activities designated as significant new uses. Certain new uses, including production volume limits and other uses designated in the proposed rules, may be claimed as CBI.
These proposed SNURs include PMN substances that are subject to Orders issued under TSCA section 5(e)(1)(A), as required by the determinations made under TSCA section 5(a)(3)(B). Those TSCA Orders require protective measures to limit exposures or otherwise mitigate the potential unreasonable risk. The proposed SNURs identify as significant new uses any manufacturing, processing, use, distribution in commerce, or disposal that does not conform to the restrictions imposed by the underlying TSCA Orders, consistent with TSCA section 5(f)(4).
C. Which chemical substances are subject to these proposed SNURs?
The substances subject to the proposed SNURs in this document are as follows, listed by PMN number and with the proposed CFR citation:
Chemical Name:
6-Octen-1-ol, 3,7-dimethyl-, homopolymer, monoacetate.
CASRN:
2417284-25-2.
Effective Date of TSCA Order:
October 27, 2025.
Basis for TSCA Order:
The PMN states that the use will be as a solubilizer and rheology modifier for use in consumer products, including but not limited to laundry detergents, cleaners, fabric softeners, air fresheners, etc. Based on comparison to analogous chemical substances, EPA has identified concerns for systemic effects. The 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. To protect against these risks, the Order requires:
Manufacture, processing, or use of the PMN substance only in a manner that does not result in inhalation exposure to the PMN substance. This requirement does not apply to use in consumer products.
No release of the PMN substance, or any waste stream containing the PMN substance, resulting in surface water concentrations that exceed 669 parts per billion; and
Establishment of a hazard communication program, including human health and environmental precautionary statements on each label and in the Safety Data Sheet (SDS).
The proposed SNUR would designate as a “significant new use” the absence of these protective measures.
Potentially Useful Information:
EPA has determined that certain information may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of specific target organ toxicity testing may be potentially useful to characterize the health effects of the PMN substance. Although the Order does not require these tests, the Order's restrictions remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information.
Chemical Names:
Alkanedioic acid, di branched alkyl esters (generic) (P-21-104) and alkanedioic acid, di C11-14 isoalkyl esters (generic) (P-21-105).
Accession Nos.:
303674 (P-21-104) and 303663 (P-21-105).
Effective Date of TSCA Order:
December 1, 2025.
Basis for TSCA Order:
The PMNs state that the generic (non-confidential) uses will be as lubricants. Based on comparison to analogous chemical substances, EPA has identified concerns for skin irritation, eye irritation, and systemic effects. The 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 substances may present an unreasonable risk of injury to human health. To protect against these risks, the Order requires:
No manufacture, processing, or use of the PMN substances in any manner that results in inhalation exposure to the PMN substances;
No processing for use or use of the PMN substances in a consumer product;
Use of personal protective equipment where there is a potential for dermal exposure; and
Establishment of a hazard communication program, including human health and environmental precautionary statements on each label and in the SDS.
The proposed SNURs would designate as a “significant new use” the absence of these protective measures.
Potentially Useful Information:
EPA has determined that certain information may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of skin irritation, eye irritation, and specific target organ toxicity testing may be potentially useful to characterize the health effects of the PMN substances. Although the Order does not require these tests, the Order's restrictions remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information.
Chemical Name:
Siloxanes and Silicones, di-Me, [alkylpiperazinium-
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hydroxyalkoxy]alkyl group-terminated, arylsulfonates (salts) (generic).
CASRN or Accession No.:
Not available.
Effective Date of TSCA Order:
September 13, 2025.
Basis for TSCA Order:
The PMN states that the use will be as a textile softening agent. Based on comparison to analogous chemical substances, EPA has identified concerns for systemic and respiratory hazards and skin sensitization. Based on comparison to analogous polycationic polymers, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 9 parts per billion. The 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. To protect against these risks, the Order requires:
Use of personal protective equipment where there is a potential for dermal exposure;
Manufacture, processing, and use of the PMN substance only in a manner that does not result in inhalation exposure to the PMN substance;
Manufacture, processing, and use of the PMN substance only in the form of a liquid solution;
No processing for use or use of the PMN substance in a consumer product;
No release of the PMN substance, or any waste stream containing the PMN substance, resulting in surface water concentrations that exceed 9 parts per billion; and
Establishment of a hazard communication program, including human health and environmental precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a “significant new use” the absence of these protective measures.
Potentially Useful Information:
EPA has determined that certain information may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of skin sensitization, pulmonary effects, specific target organ toxicity, and aquatic toxicity testing may be potentially useful to characterize the health and environmental effects of the PMN substance. Although the Order does not require these tests, the Order's restrictions remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information.
Chemical Name:
Siloxanes and silicones, di-Me, [alkylpiperazinium-hydroxyalkoxy]alkyl group- and (hydroxyalkoxy)alkyl group-terminated, ethers with polyethylene glycol alkyl ethers, arylsulfonates (salts) (generic).
CASRN or Accession No.:
Not available.
Effective Date of TSCA Order:
September 13, 2025.
Basis for TSCA Order:
The PMN states that the use will be as a textile softening agent. Based on comparison to analogous chemical substances, EPA has identified concerns for systemic and respiratory hazards and skin sensitization. Based on comparison to analogous polycationic polymers, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 0.7 parts per billion. The 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. To protect against these risks, the Order requires:
Use of personal protective equipment where there is a potential for dermal exposure;
Manufacture, processing, and use of the PMN substance only in a manner that does not result in inhalation exposure to the PMN substance;
Manufacture, processing, and use of the PMN substance only in the form of a liquid solution;
No processing for use or use of the PMN substance in a consumer product;
No release of the PMN substance, or any waste stream containing the PMN substance, resulting in surface water concentrations that exceed 0.7 parts per billion; and
Establishment of a hazard communication program, including human health and environmental precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a “significant new use” the absence of these protective measures.
Potentially Useful Information:
EPA has determined that certain information may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of skin sensitization, pulmonary effects, specific target organ toxicity, and aquatic toxicity testing may be potentially useful to characterize the health and environmental effects of the PMN substance. Although the Order does not require these tests, the Order's restrictions remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information.
Chemical Name:
Soybean oil, polymer with diethylene glycol- and glycerol- and tetraethylene glycol- and triethylene glycol-depolymd. poly(ethylene terephthalate) waste plastics, 3-hydroxy-2-(hydroxymethyl)-2-methylpropanoic acid and phthalic anhydride.
CASRN:
2803562-50-5.
Effective Date of TSCA Order:
September 18, 2025.
Basis for TSCA Order:
The PMN states that the use will be as a polyester polyol which will be used in combination with other ingredients to make the B side of a spray polyurethane foam formulation (the A side (isocyanate) and B side are reacted together to produce a polyurethane foam that is used as insulation in buildings). Based on structure, EPA has identified concerns for lung effects (surfactant effects) and eye and respiratory tract irritation. Based on test data for metabolites/ester hydrolysis products and feedstock residuals, EPA has also identified concerns for skin irritation and systemic, neurotoxic, reproductive, and developmental effects. Based on comparison to analogous esters and submitted test data on the PMN substance, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 58 parts per billion. The 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. To protect against these risks, the Order requires:
Use of personal protective equipment where there is a potential for dermal exposure;
Use of a National Institute for Occupational Safety and Health (NIOSH)-certified respirator with an Assigned Protection Factor (APF) of at least 1,000 where there is a potential for inhalation exposure;
No processing for use or use of the PMN substance in a consumer product;
Use of the PMN substance only if all of the following are true: (1) The PMN substance is used in the B side (polyol) of a spray polyurethane foam
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formulation, (2) the concentration of the PMN substance does not exceed the confidential percentage by weight on the B side listed in the Order, and (3) the PMN substance is used in an application process designed to result in instant and complete reaction of the B side containing the PMN substance with the A side (isocyanate) such that there is no unreacted polyol present in any overspray;
No release of the PMN substance, or any waste stream containing the PMN substance, resulting in surface water concentrations that exceed 58 parts per billion; and
Establishment of a hazard communication program, including human health and environmental precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a “significant new use” the absence of these protective measures.
Potentially Useful Information:
EPA has determined that certain information may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of developmental toxicity, eye irritation, metabolism or pharmacokinetics, neurotoxicity, pulmonary effects, reproductive toxicity, skin irritation, and specific target organ toxicity testing may be potentially useful to characterize the health effects of the PMN substance. Although the Order does not require these tests, the Order's restrictions remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information.
Chemical Name:
Benzoicacid,2-([1,1′-biphenyl]-4-ylcarbonyl)-,2-ethylhexylester.
CASRN:
75005-95-7.
Effective Date of TSCA Order:
October 30, 2025.
Basis for TSCA Order:
The PMN states that the use of the PMN substance will be as a photoinitiator in cooperation with amine synergists or amine acrylates in overprint varnishes (OPV) and industrial coatings (pigmented systems like offset, flexo, and inkjets). Based on the physical/chemical properties of the PMN substance (as described in the New Chemical Program's persistent, bioaccumulative, and toxic (PBT) category at 64 FR 60194; November 1999) and in the absence of data, the PMN substance is potentially a PBT chemical. EPA estimates that the PMN substance will persist in the environment for more than six months and estimates a bioaccumulation factor of >1,000 and <5,000. Based on submitted test data on the PMN substance, EPA has identified concerns for skin sensitization. Based on submitted test data on the PMN substance and comparison to analogous esters, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 0.8 parts per billion. The 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 or the environment. To protect against these risks, the Order requires:
Use of personal protective equipment where there is a potential for dermal exposure;
No processing for use or use of the PMN substance in a consumer product;
Use of the PMN substance only if the concentration of the PMN substance does not exceed 5% by weight in formulation;
No release of the PMN substance, or any waste stream containing the PMN substance, to water; and
Establishment of a hazard communication program, including human health and environmental precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a “significant new use” the absence of these protective measures.
Potentially Useful Information:
EPA has determined that certain information may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of persistence, bioaccumulation, and aquatic toxicity testing may be potentially useful to characterize the fate and environmental effects of the PMN substance. Although the Order does not require these tests, the Order's restrictions remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information.
Basis for TSCA Order:
The PMN states that the generic (non-confidential) use will be as an additive in paints, coatings, and inks, wire coatings, and paint removal formulations. Based on submitted test data on the PMN substance, EPA has identified concerns for acute toxicity, serious eye damage, and systemic effects. The 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. To protect against these risks, the Order requires:
Use of personal protective equipment where there is a potential for dermal exposure;
No processing for use or use of the PMN substance in a consumer product;
No use of the PMN substance in spray applications unless in an enclosed process;
Disposal of the PMN substance, or waste streams containing the PMN substance, only by incineration;
No release of the PMN substance, or any waste stream containing the PMN substance, resulting in surface water concentrations that exceed 3143 parts per billion; and
Establishment of a hazard communication program, including human health and environmental precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a “significant new use” the absence of these protective measures.
Potentially Useful Information:
EPA has determined that certain information may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of exposure monitoring may be potentially useful to characterize human exposures to the PMN substance. Although the Order does not require these tests, the Order's restrictions remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information.
Chemical Name:
Substituted carbopolycyclic dicarboxylic acid dialkyl ester, polymer with alkanediol, carbopolycyclic bis(substituted carbopolycycle)bis[alkanol] and carbopolycyclic bis(substituted carbomonocycle)bis[alkanol] (generic).
CASRN or Accession No.:
Not available.
( printed page 35162)
Effective Date of TSCA Order:
September 2, 2025.
Basis for TSCA Order:
The PMN states that the generic (non-confidential) use will be as a component of lenses used in electronic applications. Based on the PMN substance being a high molecular weight >10,000 Daltons) insoluble polymer, EPA has identified concerns for lung overload. The 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. To protect against these risks, the Order requires:
Establishment of a hazard communication program, including human health and environmental precautionary statements on each label and in the SDS; and
Manufacture of the PMN substance only when at least one of the following is true: (1) the PMN substance has a mean particle size equal to or greater than 2.5 millimeters or (2) where the percentage of particles of the PMN substance with a diameter less than 1.4 millimeters is less than or equal to 0.01 percent by weight.
The proposed SNUR would designate as a “significant new use” the absence of these protective measures.
Potentially Useful Information:
EPA has determined that certain information may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of pulmonary effects testing may be potentially useful to characterize the health effects of the PMN substance. Although the Order does not require these tests, the Order's restrictions remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information.
Chemical Name:
Polymeric salt of propenoic acid, acrylamido-methylpropane sulfonic acid sodium salt, hydroxyethyl methacrylate, methyl methacrylate, propenoic acid, methyl-, phosphinicobis(oxy-ethanediyl) ester, sodium metabisulfite (generic).
CASRN or Accession No.:
Not available.
Effective Date of TSCA Order:
October 8, 2025.
Basis for TSCA Order:
The PMN states that the use will be as an oilfield production scale inhibitor for descaling processing equipment and oil field applications. Based on comparison to analogous polyanionic polymers (and monomers), EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 316 parts per billion. The 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 the environment. To protect against these risks, the Order requires:
No release of the PMN substance, or any waste stream containing the PMN substance, resulting in surface water concentrations that exceed 316 parts per billion; and
Establishment of a hazard communication program, including human health and environmental precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a “significant new use” the absence of these protective measures.
Potentially Useful Information:
EPA has determined that certain information may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be 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 PMN substance. Although the Order does not require these tests, the Order's restrictions remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information.
Chemical Name:
2-Propanamine, N,N′-(oxydi-2,1-ethanediyl)bis[N-methyl-.
CASRN:
2484716-03-0.
Effective Date of TSCA Order:
October 1, 2025.
Basis for TSCA Order:
The PMN states that the use will be as a catalyst in two-part polyurethane spray foam insulation applications. Based on submitted test data on the PMN substance, EPA has identified concerns for skin corrosion. Based on comparison to analogous chemical substances, EPA has also identified concerns for acute toxicity, eye corrosion, and systemic and developmental effects. Based on concerns for eye and skin corrosion, EPA has also identified concerns for respiratory corrosion. Based on comparison to analogous aliphatic amines and submitted test data on the PMN substance, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 89 parts per billion. The 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. To protect against these risks, the Order requires:
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 processing for use or use of the PMN substance in a consumer product;
Processing for use or use of the PMN substance only as a catalyst in two-part polyurethane spray foam insulation applications;
Processing for use or use of the PMN substance only if the concentration of the PMN substance does not exceed 3 percent by weight in formulation;
No release of the PMN substance, or any waste stream containing the PMN substance, resulting in surface water concentrations that exceed 89 parts per billion; and
Establishment of a hazard communication program, including human health and environmental precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a “significant new use” the absence of these protective measures.
Potentially Useful Information:
EPA has determined that certain information may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of eye corrosion, developmental toxicity, pulmonary effects, reproductive toxicity, and specific target organ toxicity testing may be potentially useful to characterize the health effects of the PMN substance. Although the Order does not require these tests, the Order's restrictions remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information.
Chemical Name:
Polyalkyl substituted amine, hydrolysis products with alkenyltrialkoxymetalloid and silica (generic).
( printed page 35163)
CASRN or Accession No.:
Not available.
Effective Date of TSCA Order:
September 5, 2025.
Basis for TSCA Order:
The PMN states that the generic (non-confidential) use will be as a component used in the manufacture of electronics. Based on physical/chemical properties and comparison to analogous respirable, poorly soluble particulates, EPA has identified concerns for lung effects (lung overload). Based on comparison to analogous chemical substances, EPA has also identified concerns for lung and respiratory tract effects. Due to insufficient information, EPA was unable to estimate the environmental hazard of the PMN substance. The 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. To protect against these risks, the Order requires:
Use of a NIOSH-certified respirator with an APF of at least 1,000 where there is a potential for inhalation exposure;
No processing for use or use of the PMN substance in a consumer product;
No exceedance of the confidential annual production volume listed in the Order;
No release of the PMN substance, or any waste stream containing the PMN substance, to water; and
Establishment of a hazard communication program, including human health and environmental precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a “significant new use” the absence of these protective measures.
Potentially Useful Information:
EPA has determined that certain information may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of pulmonary effects and aquatic toxicity testing may be potentially useful to characterize the health and environmental effects of the PMN substance. Although the Order does not require these tests, the Order's restrictions remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information.
Chemical Names:
Alkanol, alkoxyalkylimino, salt (generic) (P-24-46) and alkanol, nitrilo, salt (generic) (P-24-47).
CASRNs or Accession Nos.:
Not available.
Effective Date of TSCA Order:
November 24, 2025.
Basis for TSCA Order:
The PMNs state that the uses will be as grinding aids used in cement manufacture. Based on comparison to analogous chemical substances, EPA has identified concerns for eye corrosion, respiratory tract irritation, and systemic and developmental effects. Based on comparison to analogous aliphatic amines, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 101 parts per billion. The 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 substances may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the Order requires:
No manufacture, processing, or use of the PMN substances in any manner that results in inhalation exposure to the PMN substances;
Manufacture, processing, and use of the PMN substances only in liquid solution;
No processing for use or use of the PMN substances in a consumer product;
Use of personal protective equipment where there is a potential for dermal exposure;
No release of the PMN substances, or any waste stream containing the PMN substances, resulting in surface water concentrations that exceed 101 parts per billion of the P-24-46 and P-24-47 substances in aggregate; and
Establishment of a hazard communication program, including human health and environmental precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a “significant new use” the absence of these protective measures.
Potentially Useful Information:
EPA has determined that certain information may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of eye irritation/corrosion, specific target organ toxicity, pulmonary effects, developmental toxicity, and aquatic toxicity testing may be potentially useful to characterize the health and environmental effects of the PMN substances. Although the Order does not require these tests, the Order's restrictions remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information.
Chemical Name:
Aryl-dicarboxylic acid, polymer with alkanedioic acid, 2,2′-oxypoly[alkanol], polymethylenepolyphenylene isocyanate and alkane diol (generic).
CASRN or Accession No.:
Not available.
Effective Date of TSCA Order:
November 24, 2025.
Basis for TSCA Order:
The PMN states that the use will be as an adhesive sealant foam for use in construction. Based on comparison to analogous diisocyanates, EPA has identified concerns for acute toxicity, irritation to the skin, eyes, and respiratory tract, skin sensitization, respiratory sensitization, and pulmonary effects. The 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. To protect against these risks, the Order requires:
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 1,000 where there is a potential for inhalation exposure;
Manufacture of the PMN substance only by import in a liquid solution into the United States (i.e.,
no domestic manufacture);
Manufacture, processing, and use of the PMN substance only if the concentration of the PMN substance does not exceed the confidential percentage in solution by weight listed in the Order;
Manufacture, processing, and use of the PMN substance only if the proportion of the PMN substance below 1,000 Daltons does not exceed the confidential percentage by weight listed in the Order;
Manufacture, processing, and use of the PMN substance only if the concentration of the confidential residual feedstock listed in the Order does not exceed the confidential percentage by weight listed in the Order;
( printed page 35164)
No processing for use or use of the PMN substance in a consumer product;
Use of the PMN substance only for use as an adhesive sealant foam for use in construction; and
Establishment of a hazard communication program, including human health and environmental precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a “significant new use” the absence of these protective measures.
Potentially Useful Information:
EPA has determined that certain information may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of acute toxicity, eye irritation, pulmonary effects, skin irritation, skin sensitization, and specific target organ toxicity testing may be potentially useful to characterize the health effects of the PMN substance. Although the Order does not require these tests, the Order's restrictions remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information.
Chemical Name:
Carbonic acid diaryl ester with alkanediol (generic).
CASRN or Accession No.:
Not available.
Effective Date of TSCA Order:
January 7, 2026.
Basis for TSCA Order:
The PMN states that the generic (non-confidential) use will be as a raw material of polyurethane. Based on comparison to analogous chemical substances, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 22 parts per billion. The 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 the environment. To protect against these risks, the Order requires:
No processing for use or use of the PMN substance in a consumer product;
No release of the PMN substance, or any waste stream containing the PMN substance, resulting in surface water concentrations that exceed 22 parts per billion; and
Establishment of a hazard communication program, including human health and environmental precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a “significant new use” the absence of these protective measures.
Potentially Useful Information:
EPA has determined that certain information may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be 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 PMN substance. Although the Order does not require these tests, the Order's restrictions remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information.
Chemical Name:
1,3-Butanediol, 4,4,4-trifluoro-3-(trifluoromethyl)-.
CASRN:
21379-33-9.
Effective Date of TSCA Order:
December 16, 2025.
Basis for TSCA Order:
The PMN states that the generic (non-confidential) use will be as a chemical intermediate. Based on submitted test data on the PMN substance, EPA has identified concerns for skin corrosion. Based on comparison to analogous chemical substances, EPA has also identified concerns for acute (oral) toxicity, corrosion to the eyes and respiratory tract, and neurological, systemic, reproductive, and developmental effects. The 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. To protect against these risks, the Order requires:
Use of a NIOSH-certified respirator with an APF of at least 50 where there is a potential for inhalation exposure;
Use of personal protective equipment where there is a potential for dermal exposure;
Use of the PMN substance only 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.
The proposed SNUR would designate as a “significant new use” the absence of these protective measures.
Potentially Useful Information:
EPA has determined that certain information may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of inhalation exposure monitoring and acute toxicity, developmental toxicity, developmental neurotoxicity, eye irritation/corrosion, neurotoxicity, pulmonary effects, reproductive toxicity, and specific target organ toxicity testing may be potentially useful to characterize the health effects of the PMN substance. Although the Order does not require these tests, the Order's restrictions remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information.
Basis for TSCA Order:
The PMNs state that the generic (non-confidential) uses will be as components of photoresist. Based on the physical/chemical properties of the PMN substances (as described in the New Chemical Program's PBT category at 64 FR 60194; November 1999) and in the absence of data, the anion and cation of the PMN substances and the cation photodegradation product of the P-25-106 substance are potentially persistent, bioaccumulative, and toxic (PBT) chemicals. EPA estimates that the anions and cations of the PMN substances will persist in the environment for more than six months and that their potential to bioaccumulate is unknown. EPA estimates that the cation photodegradation products of the PMN substances will persist in the environment for more than six months. For the cation photodegradation product of the P-24-0106 substance, the potential to bioaccumulate is unknown. Based on comparison to analogous chemical substances, EPA has identified concerns for irritation to the skin and respiratory tract, eye corrosion, and neurological and systemic effects for the cation of the P-25-106 substance. Based on photoreactivity, EPA has also identified concerns for skin photosensitization for the P-25-106 substance. Based on comparison to analogous chemical substances, EPA has
( printed page 35165)
also identified concerns for skin irritation and eye corrosion for the P-25-106 substance. Based on submitted test data on the PMN substance, comparison to analogous chemical substances, and reactivity of the PMN substance, EPA has also identified concerns for acute toxicity (inhalation and dermal routes), irritation to the skin and respiratory tract, eye corrosion, skin sensitization and photosensitization, genetic toxicity, and neurological and systemic effects for the P-25-107 substance. Due to insufficient information, EPA was unable to estimate the environmental hazard of the PMN substances. The 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 substances may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the Order requires:
No manufacture of the PMN substances beyond the time limits specified in the Order without submittal to EPA of the results of certain testing described in the Testing section of the Order;
Use of personal protective equipment where there is a potential for dermal exposure;
Establishment of a hazard communication program, including human health and environmental precautionary statements on each label and in the SDS;
No processing of the PMN substances in any way that generates vapor, dust, mist, or aerosol in a non-enclosed process;
Use of the PMN substances only for the confidential use listed in the Order;
No domestic manufacture of the PMN substance (i.e.,
import only);
Import of the PMN substance only in solution, unless in sealed containers weighing 5 kilograms or less; and
No exceedance of the confidential annual importation volume listed the Order.
The proposed SNUR would designate as a “significant new use” the absence of these protective measures.
Potentially Useful Information:
EPA has determined that certain information about the physical/chemical properties, fate, bioaccumulation, environmental hazard, and human health effects of the PMN substances may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. The submitter has agreed not to exceed the time limits specified in the Order without performing the required Tier I and Tier II testing outlined in the Testing section of the Order.
This action proposes to establish SNURs for new chemical substances that were the subject of PMNs. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866 (58 FR 51735, October 4, 1993).
According to the PRA (44 U.S.C. 3501et seq.), an agency may not conduct or sponsor, and a person is not required to respond to a collection of information that requires OMB approval under PRA, unless it has been approved by OMB and displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in title 40 of the CFR, after appearing in the
Federal Register
, are listed in 40 CFR part 9, and included on the related collection instrument or form, if applicable.
The information collection requirements related to SNURs have already been approved by OMB pursuant to PRA under OMB control number 2070-0038 (EPA ICR No. 1188). This action does not impose any burden requiring additional 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. 601et 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 large entities presently engage in such activities.
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 23 in FY2023, 7 in FY2024, and 10 in FY2025, and only a fraction of these submissions were 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 $14,967 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
( printed page 35166)
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.
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
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).
Soybean oil, polymer with diethylene glycol- and glycerol- and tetraethylene glycol- and triethylene glycol-depolymd. poly(ethylene terephthalate) waste plastics, 3-hydroxy-2-(hydroxymethyl)-2-methylpropanoic acid and phthalic anhydride.
(a)
Chemical substance and significant new uses subject to reporting.
(1) The chemical substance identified as 6-octen-1-ol, 3,7-dimethyl-, homopolymer, monoacetate (PMN P-20-174; CASRN 2417284-25-2) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i)
Hazard communication.
Requirements as specified in § 721.72(a) through (d), (f), and (g)(1) and (5). For purposes of § 721.72(g)(1), this substance may cause: specific target organ toxicity. Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.
(ii)
Industrial, commercial, and consumer activities.
It is a significant new use to manufacture, process, or use the substance in any manner that results in worker inhalation exposure to the substance.
(iii)
Release to water.
Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4), where N=669.
( printed page 35167)
(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 (c), (f) through (i), and (k) are applicable to manufacturers, importers, and processors of this substance.
(2)
Limitation or revocation of certain notification requirements.
The provisions of § 721.185 apply to this section.
Alkanedioic acid, di branched alkyl esters (generic).
(a)
Chemical substance and significant new uses subject to reporting.
(1) The chemical substance identified generically as alkanedioic acid, di branched alkyl esters (PMN P-21-104; Accession No. 303674) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i)
Protection in the workplace.
Requirements as specified in § 721.63(a)(1) and (3) and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1), engineering control measures (
e.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.
(ii)
Hazard communication.
Requirements as specified in § 721.72(a) through (d), (f), and (g)(1) and (5). For purposes of § 721.72(g)(1), this substance may cause: skin irritation, eye irritation, and specific target organ toxicity. 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, process, or use the substance in any manner that results in inhalation exposure to the substance.
(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) are applicable to manufacturers, importers, and processors of this substance.
(2)
Limitation or revocation of certain notification requirements.
The provisions of § 721.185 apply to this section.
Alkanedioic acid, di C11-14 isoalkyl esters (generic).
(a)
Chemical substance and significant new uses subject to reporting.
(1) The chemical substance identified generically as alkanedioic acid, di C11-14 isoalkyl esters (PMN P-21-105; Accession No. 303663) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i)
Protection in the workplace.
Requirements as specified in § 721.63(a)(1) and (3) and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1), engineering control measures (
e.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.
(ii)
Hazard communication.
Requirements as specified in § 721.72(a) through (d), (f), and (g)(1) and (5). For purposes of § 721.72(g)(1), this substance may cause: skin irritation, eye irritation, and specific target organ toxicity. 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, process, or use the substance in any manner that results in inhalation exposure to the substance.
(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) are applicable to manufacturers, importers, and processors of this substance.
(2)
Limitation or revocation of certain notification requirements.
The provisions of § 721.185 apply to this section.
Siloxanes and silicones, di-Me, [alkylpiperazinium-hydroxyalkoxy]alkyl group-terminated, arylsulfonates (salts) (generic).
(a)
Chemical substance and significant new uses subject to reporting.
(1) The chemical substance identified generically as siloxanes and silicones, di-Me, [alkylpiperazinium-hydroxyalkoxy]alkyl group-terminated, arylsulfonates (salts) (PMN P-21-166) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance when contained in an article as defined at 40 CFR 720.3(c).
(2) The significant new uses are:
(i)
Protection in the workplace.
Requirements as specified in § 721.63(a)(1) and (3) and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1), engineering control measures (
e.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.
(ii)
Hazard communication.
Requirements as specified in § 721.72(a) through (d), (f), (g)(1), (g)(3)(iii), and (g)(5). For purposes of § 721.72(g)(1), this substance may cause: skin sensitization and specific target organ toxicity. 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, process, or use the substance other than in the form of a liquid solution. It is a significant new use to manufacture, process, or use the substance in any manner that results in inhalation exposure to the substance.
(iv)
Release to water.
Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4), where N=9. For purposes of § 721.91(a)(7), the control technology is primary and secondary wastewater treatment as defined in 40 CFR part 133 and the percentage removal of the substance resulting from use of the specified control technology is 90%.
(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, importers, and processors of this substance.
(2)
Limitation or revocation of certain notification requirements.
The provisions of § 721.185 apply to this section.
Siloxanes and silicones, di-Me, [alkylpiperazinium-hydroxyalkoxy]alkyl group- and (hydroxyalkoxy)alkyl group-terminated, ethers with polyethylene glycol alkyl ethers, arylsulfonates (salts) (generic).
(a)
Chemical substance and significant new uses subject to reporting.
(1) The chemical substance identified generically as siloxanes and silicones, di-Me, [alkylpiperazinium-hydroxyalkoxy]alkyl group- and (hydroxyalkoxy)alkyl group-terminated, ethers with polyethylene glycol alkyl ethers, arylsulfonates (salts) (PMN P-21-167) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance when contained in an article as defined at 40 CFR 720.3(c).
(2) The significant new uses are:
(i)
Protection in the workplace.
Requirements as specified in § 721.63(a)(1) and (3) and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1), engineering control measures (
e.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.
(ii)
Hazard communication.
Requirements as specified in § 721.72(a) through (d), (f), (g)(1), (g)(3)(iii), and (g)(5). For purposes of § 721.72(g)(1), this substance may cause: skin sensitization and specific target organ toxicity. 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, process, or use the substance other than in the form of a liquid solution. It is a significant new use to manufacture, process, or use the substance in any manner that results in inhalation exposure to the substance.
(iv)
Release to water.
Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4), where N=0.7. For purposes of § 721.91(a)(7), the control technology is primary and secondary wastewater treatment as defined in 40 CFR part 133 and the percentage removal of the substance resulting from use of the specified control technology is 90%.
(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, importers, and processors of this substance.
(2)
Limitation or revocation of certain notification requirements.
The provisions of § 721.185 apply to this section.
Soybean oil, polymer with diethylene glycol- and glycerol- and tetraethylene glycol- and triethylene glycol-depolymd. poly(ethylene terephthalate) waste plastics, 3-hydroxy-2-(hydroxymethyl)-2-methylpropanoic acid and phthalic anhydride.
(a)
Chemical substance and significant new uses subject to reporting.
(1) The chemical substance identified as soybean oil, polymer with diethylene glycol- and glycerol- and tetraethylene glycol- and triethylene glycol-depolymd. poly(ethylene terephthalate) waste plastics, 3-hydroxy-2-(hydroxymethyl)-2-methylpropanoic acid and phthalic anhydride (PMN P-23-78; CASRN 2803562-50-5) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely reacted or cured (
i.e.,
the substance has been reacted or cured to the extent that no release of the substance can be detected).
(2) The significant new uses are:
(i)
Protection in the workplace.
Requirements as specified in § 721.63(a)(1), (3) through (6), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1) and (4), engineering control measures (
e.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 1,000.
(ii)
Hazard communication.
Requirements as specified in § 721.72(a) through (d), (f), (g)(1), (g)(3)(iii), and (g)(5). For purposes of § 721.72(g)(1), this substance may cause: skin irritation, eye irritation, reproductive toxicity, and specific target organ toxicity. 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 use the substance unless all of the following are true: (1) the substance is used in the B side (polyol) of a spray polyurethane foam formulation, (2) the concentration of the substance on the B side does not exceed the confidential percentage by weight listed in the Order, and (3) the substance is used in an application process designed to result in instant and complete reaction of the B side containing the substance with the A side (isocyanate) such that there is no unreacted polyol present in any overspray.
(iv)
Release to water.
Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4), where N=58.
(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, importers, and processors of this substance.
(2)
Limitation or revocation of certain notification requirements.
The provisions of § 721.185 apply to this section.
(a)
Chemical substance and significant new uses subject to reporting.
(1) The chemical substance identified as benzoicacid,2-([1,1′-biphenyl]-4-ylcarbonyl)-,2-ethylhexylester (PMN P-23-138; CASRN 75005-95-7) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely reacted or cured (
i.e.,
the substance has been reacted or cured to the extent that no release of the substance can be detected).
(2) The significant new uses are:
(i)
Protection in the workplace.
Requirements as specified in § 721.63(a)(1) and (3) and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1), engineering control measures (
e.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.
(ii)
Hazard communication.
Requirements as specified in § 721.72(a)
( printed page 35169)
through (d), (f), (g)(1), g(3)(iii), and (g)(5). For purposes of § 721.72(g)(1), this substance may cause: skin sensitization. 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 use the substance at a concentration greater than 5% by weight in formulation.
(iv)
Release to water.
Requirements as specified in § 721.90(a)(1), (b)(1), and (c)(1).
(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, importers, and processors of this substance.
(2)
Limitation or revocation of certain notification requirements.
The provisions of § 721.185 apply to this section.
(a)
Chemical substance and significant new uses subject to reporting.
(1) The chemical substance identified generically as ethyl modified lactam (PMN P-23-183) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely reacted or cured (
i.e.,
the substance has been reacted or cured to the extent that no release of the substance can be detected).
(2) The significant new uses are:
(i)
Protection in the workplace.
Requirements as specified in § 721.63(a)(1) and (3) and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1), engineering control measures (
e.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.
(ii)
Hazard communication.
Requirements as specified in § 721.72(a) through (d), (f), and (g)(1) and (5). For purposes of § 721.72(g)(1), this substance may cause: acute toxicity, serious eye damage, and specific target organ toxicity. 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 use the substance in spray applications unless in an enclosed process.
(iv)
Disposal.
Requirements as specified in § 721.85(a)(1), (b)(1), and (c)(1).
(v)
Release to water.
Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4), where N=3143.
(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 (k) are applicable to manufacturers, importers, and processors of this substance.
(2)
Limitation or revocation of certain notification requirements.
The provisions of § 721.185 apply to this section.
Substituted carbopolycyclic dicarboxylic acid dialkyl ester, polymer with alkanediol, carbopolycyclic bis(substituted carbopolycycle)bis[alkanol] and carbopolycyclic bis(substituted carbomonocycle)bis[alkanol] (generic).
(a)
Chemical substance and significant new uses subject to reporting.
(1) The chemical substance identified generically as substituted carbopolycyclic dicarboxylic acid dialkyl ester, polymer with alkanediol, carbopolycyclic bis(substituted carbopolycycle)bis[alkanol] and carbopolycyclic bis(substituted carbomonocycle)bis[alkanol] (PMN P-23-193) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been incorporated into an article as defined at 40 CFR 720.3(c).
(2) The significant new uses are:
(i)
Hazard communication.
Requirements as specified in § 721.72(a) through (d), (f), and (g)(1) and (5). For purposes of § 721.72(g)(1), this substance may cause: specific target organ toxicity. Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.
(ii)
Industrial, commercial, and consumer activities.
It is a significant new use to manufacture the substance in any manner unless at least one of the following is true: (1) the substance has a mean particle size equal to or greater than 2.5 millimeters or (2) where the percentage of particles of the substance with a diameter less than 1.4 millimeters is less than or equal to 0.01 percent by weight.
(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 (c) and (f) through (i) are applicable to manufacturers, importers, and processors of this substance.
(2)
Limitation or revocation of certain notification requirements.
The provisions of § 721.185 apply to this section.
(a)
Chemical substance and significant new uses subject to reporting.
(1) The chemical substance identified generically as polymeric salt of propenoic acid, acrylamido-methylpropane sulfonic acid sodium salt, hydroxyethyl methacrylate, methyl methacrylate, propenoic acid, methyl-, phosphinicobis(oxy-ethanediyl) ester, sodium metabisulfite (PMN P-24-6;) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i)
Hazard communication.
Requirements as specified in § 721.72(a) through (d), (f), and (g)(3)(iii) and(5). Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.
(ii)
Release to water.
Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4), where N=316.
(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 (c), (f) through (h), and (k) are applicable to manufacturers, importers, and processors of this substance.
(2)
Limitation or revocation of certain notification requirements.
The provisions of § 721.185 apply to this section.
(a)
Chemical substance and significant new uses subject to reporting.
(1) The chemical substance identified as 2-propanamine, N,N′-(oxydi-2,1-ethanediyl)bis[N-methyl- (PMN P-24-16; CASRN 2484716-03-0) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely reacted or cured (
i.e.,
the substance has been reacted or cured to the extent that no release of the substance can be detected).
(2) The significant new uses are:
(i)
Protection in the workplace.
Requirements as specified in § 721.63(a)(1), (3) through (6), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1) and (4), engineering control measures (
e.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), (g)(3)(iii), and (g)(5). For purposes of § 721.72(g)(1), this substance may cause: acute toxicity, skin corrosion, serious eye damage, reproductive toxicity, and specific target organ toxicity. 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 process or use the substance other than as a catalyst in two-part polyurethane spray foam insulation applications. It is a significant new use to process or use the substance at a concentration greater than 3 percent by weight in formulation.
(iv)
Release to water.
Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4), where N=89.
(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, importers, and processors of this substance.
(2)
Limitation or revocation of certain notification requirements.
The provisions of § 721.185 apply to this section.
Polyalkyl substituted amine, hydrolysis products with alkenyltrialkoxymetalloid and silica (generic).
(a)
Chemical substance and significant new uses subject to reporting.
(1) The chemical substance identified generically as polyalkyl substituted amine, hydrolysis products with alkenyltrialkoxymetalloid and silica (PMN P-24-20) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely reacted or cured (
i.e.,
the substance has been reacted or cured to the extent that no release of the substance can be detected).
(2) The significant new uses are:
(i)
Protection in the workplace.
Requirements as specified in § 721.63(4) through (6), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(4), engineering control measures (
e.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 1,000.
(ii)
Hazard communication.
Requirements as specified in § 721.72(a) through (d), (f), (g)(1), (g)(3)(iii), and (g)(5). For purposes of § 721.72(g)(1), this substance may cause: specific target organ toxicity. 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 beyond the confidential annual production volume listed in the Order.
(iv)
Release to water.
Requirements as specified in § 721.90(a)(1), (b)(1), and (c)(1).
(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, importers, and processors of this substance.
(2)
Limitation or revocation of certain notification requirements.
The provisions of § 721.185 apply to this section.
(a)
Chemical substance and significant new uses subject to reporting.
(1) The chemical substance identified generically as alkanol, alkoxyalkylimino, salt (PMN P-24-46) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i)
Protection in the workplace.
Requirements as specified in § 721.63(a)(1) and (3) and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1), engineering control measures (
e.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.
(ii)
Hazard communication.
Requirements as specified in § 721.72(a) through (d), (f), (g)(1), (g)(3)(iii), and (g)(5). For purposes of § 721.72(g)(1), this substance may cause: serious eye damage and specific target organ toxicity. 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, process, or use the substance in any manner that results in inhalation exposure to the substance. It is a significant new use to manufacture, process, or use the substance other than in liquid solution.
(iv)
Release to water.
Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4) where N=101 in aggregate of P-24-46 and P-24-47.
(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
( printed page 35171)
applicable to manufacturers, importers, and processors of this substance.
(2)
Limitation or revocation of certain notification requirements.
The provisions of § 721.185 apply to this section.
(a)
Chemical substance and significant new uses subject to reporting.
(1) The chemical substance identified generically as alkanol, nitrilo, salt (PMN P-24-47) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i)
Protection in the workplace.
Requirements as specified in § 721.63(a)(1) and (3) and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1), engineering control measures (
e.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.
(ii)
Hazard communication.
Requirements as specified in § 721.72(a) through (d), (f), (g)(1), (g)(3)(iii), and (g)(5). For purposes of § 721.72(g)(1), this substance may cause: serious eye damage and specific target organ toxicity. 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, process, or use the substance in any manner that results in inhalation exposure to the substance. It is a significant new use to manufacture, process, or use the substance other than in liquid solution.
(iv)
Release to water.
Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4) where N=101 in aggregate of P-24-46 and P-24-47.
(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, importers, and processors of this substance.
(2)
Limitation or revocation of certain notification requirements.
The provisions of § 721.185 apply to this section.
Aryl-dicarboxylic acid, polymer with alkanedioic acid, 2,2′-oxypoly[alkanol], polymethylenepolyphenylene isocyanate and alkane diol (generic).
(a)
Chemical substance and significant new uses subject to reporting.
(1) The chemical substance identified generically as aryl-dicarboxylic acid, polymer with alkanedioic acid, 2,2′-oxypoly[alkanol], polymethylenepolyphenylene isocyanate and alkane diol (PMN P-24-70) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely reacted or cured (
i.e.,
the substance has been reacted or cured to the extent that no release of the substance can be detected).
(2) The significant new uses are:
(i)
Protection in the workplace.
Requirements as specified in § 721.63(a)(1), (3) through (6), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1) and (4), engineering control measures (
e.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 1,000.
(ii)
Hazard communication.
Requirements as specified in § 721.72(a) through (d), (f), and (g)(1) and (5). For purposes of § 721.72(g)(1), this substance may cause: acute toxicity, eye irritation, respiratory sensitization, skin irritation, skin sensitization, and specific target organ toxicity. 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 other than by import in a liquid solution into the United States (
i.e.,
no domestic manufacture). It is a significant new use to manufacture, process, or use the substance if the concentration of the substance in solution exceeds the confidential percentage by weight listed in the Order. It is a significant new use to manufacture, process, or use the substance if the proportion of the substance below 1,000 Daltons exceeds the confidential percentage by weight listed in the Order. It is a significant new use to manufacture, process, or use the substance if the concentration of the confidential residual feedstock exceeds the confidential percentage by weight listed in the Order. It is a significant new use to use the substance other than as an adhesive sealant foam for use in construction.
(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) are applicable to manufacturers, importers, and processors of this substance.
(2)
Limitation or revocation of certain notification requirements.
The provisions of § 721.185 apply to this section.
Carbonic acid diaryl ester with alkanediol (generic).
(a)
Chemical substance and significant new uses subject to reporting.
(1) The chemical substance identified generically as carbonic acid diaryl ester with alkanediol (PMN P-24-105) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i)
Hazard communication.
Requirements as specified in § 721.72(a) through (d), (f), and (g)(3)(iii) and (5). Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.
(ii)
Industrial, commercial, and consumer activities.
Requirements as specified in § 721.80(o).
(iii)
Release to water.
Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4), where N=22.
(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 (c), (f) through (i), and (k) are applicable to manufacturers, importers, and processors of this substance.
(2)
Limitation or revocation of certain notification requirements.
The provisions of § 721.185 apply to this section.
(a)
Chemical substance and significant new uses subject to reporting.
( printed page 35172)
(1) The chemical substance identified as 1,3-butanediol, 4,4,4-trifluoro-3-(trifluoromethyl)- (PMN P-24-114; CASRN 21379-33-9) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i)
Protection in the workplace.
Requirements as specified in § 721.63(a)(1), (3) through (6), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1) and (4), engineering control measures (
e.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), and (g)(1) and (5). For purposes of § 721.72(g)(1), this substance may cause: acute toxicity, skin corrosion, eye corrosion, reproductive toxicity, and specific target organ toxicity. 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(k).
(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) are applicable to manufacturers, importers, and processors of this substance.
(2)
Limitation or revocation of certain notification requirements.
The provisions of § 721.185 apply to this section.
(a)
Chemical substance and significant new uses subject to reporting.
(1) The chemical substance identified generically as sulfonium tris(substitutedcarbomonocycle) substituted oxatricycloalkyloxycarbonyl dihalo alkane sulfonate (PMN P-25-106) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely reacted or adhered (during photolithographic processes) onto a semiconductor wafer surface or similar manufactured article used in the production of semiconductor technologies.
(2) The significant new uses are:
(i)
Protection in the workplace.
Requirements as specified in § 721.63(a)(1), (a)(2)(i) and (iii), (a)(3), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1), engineering control measures (
e.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.
(ii)
Hazard communication.
Requirements as specified in § 721.72(a) through (f), (g)(1), (g)(2)(i) through (iii) and (v), (g)(3)(i) and (ii), and (g)(5). For purposes of § 721.72(e), the concentration is set at 1.0%. For purposes of § 721.72(g)(1), this substance may cause: acute toxicity, skin irritation, serious eye damage, skin sensitization, genetic toxicity, and specific target organ toxicity. 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(f), (k), and (t). It is a significant new use to import the substance other than in solution, unless in sealed containers weighing 5 kilograms or less. It is a significant new use to process the substance in any way that generates vapor, dust, mist, or aerosol in a non-enclosed process. It is a significant new use to manufacture the substance longer than 18 months.
(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) are applicable to manufacturers, importers, and processors of this substance.
(2)
Limitation or revocation of certain notification requirements.
The provisions of § 721.185 apply to this section.
(a)
Chemical substance and significant new uses subject to reporting.
(1) The chemical substance identified generically as heteromonocyclic alkylsubstituted carbomonocyclic carbopolycyclic heteromonocyclic dihalo sulfoacetate (PMN P-25-107) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely reacted or adhered (during photolithographic processes) onto a semiconductor wafer surface or similar manufactured article used in the production of semiconductor technologies.
(2) The significant new uses are:
(i)
Protection in the workplace.
Requirements as specified in § 721.63(a)(1), (a)(2)(i) and (iii), (a)(3), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1), engineering control measures (
e.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.
(ii)
Hazard communication.
Requirements as specified in § 721.72(a) through (f), (g)(1), (g)(2)(i) through (iii) and (v), (g)(3)(i) and (ii), and (g)(5). For purposes of § 721.72(e), the concentration is set at 1.0%. For purposes of § 721.72(g)(1), this substance may cause: acute toxicity, skin irritation, serious eye damage, skin sensitization, genetic toxicity, and specific target organ toxicity. 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(f), (k), and (t). It is a significant new use to import the substance other than in solution, unless in sealed containers weighing 5 kilograms or less. It is a significant new use to process the substance in any way that generates vapor, dust, mist, or aerosol in a non-enclosed process. It is a significant new use to manufacture the substance longer than 18 months.
(b)
Specific requirements.
The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).
( printed page 35173)
(1)
Recordkeeping.
Recordkeeping requirements as specified in § 721.125(a) through (i) are applicable to manufacturers, importers, and processors of this substance.
(2)
Limitation or revocation of certain notification requirements.
The provisions of § 721.185 apply to this section.
Use this for formal legal and research references to the published document.
91 FR 35156
Web Citation
Suggested Web Citation
Use this when citing the archival web version of the document.
“Significant New Use Rules on Certain Chemical Substances (26-1),” thefederalregister.org (June 10, 2026), https://thefederalregister.org/documents/2026-11593/significant-new-use-rules-on-certain-chemical-substances-26-1.