# 91 FR 22075: Significant New Use Rules on Certain Chemical Substances (26-2)

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/FR_PRORULE_2026-08012

## Section

- **Citation:** 91 FR 22075
- **Heading:** Significant New Use Rules on Certain Chemical Substances (26-2)
- **Jurisdiction:** Federal
- **Kind:** Regulations
- **Status:** In force
- **Text as of:** August 14, 2026
- **Source:** Compiled text
- **Location:** Federal Register / Vol. 91 / 91 FR 22075

## Text

ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 721 [EPA-HQ-OPPT-2025-2932; FRL-13085-01-OCSPP] RIN 2070-AB27 Significant New Use Rules on Certain Chemical Substances (26-2) AGENCY:
Environmental Protection Agency (EPA).

ACTION:
Proposed rule.

SUMMARY:
EPA is issuing 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 to notify EPA at least 90 days before commencing the manufacture (defined by statute to include import) or processing of any of these chemical substances for an activity that is designated as a significant new use in the SNUR. 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 May 26, 2026.

ADDRESSES:
Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2025-2932 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: James Yan, New Chemicals Division (7405M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave
losure 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: James Yan, New Chemicals Division (7405M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: (202) 564-2138; email address: yan.james@epa.gov.
For general information on SNURs: William Wysong, New Chemicals Division (7405M), Office of Pollution wysong.william@epa.gov.
For general information on TSCA: The TSCA Assistance Information Service Hotline, Goodwill Vision Enterprises, 422 South Clinton Ave., Rochester, NY 14620; telephone number: (800) 471-7127 or (202) 554-1404; email address: TSCA-Hotline@epa.gov.

SUPPLEMENTARY INFORMATION:
I. Executive Summary
A. What is the Agency's authority for taking this action?
TSCA section 5(a)(2) (15 U.S.C. 2604(a)(2)) authorizes EPA to determine that a use of a chemical substance is a “significant new use.” EPA must make this determination by rule after considering all relevant factors, including the factors in TSCA section 5(a)(2) (see also the discussion in Unit II.).
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
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 May 26, 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 SNUN reporting requirements for potential manufacturers (including importers) and processors of the chemical substances subject to SNURs, which applies to the chemical substances in this rulemaking. 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 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
. Additional consent orders with similar protective measures are outstanding for other PMNs submitted for the same chemical substances. Those other PMN numbers align with the SNURs in this proposed rule as follows:
• for 40 CFR 721.12219, the additional PMNs are P-23-120, P-25-93, P-25-125, P-25-135, and P-25-145.
• for 40 CFR 721.12220, the additional PMNs are P-23-122, P-24-180, and P-25-144.
The proposed SNURs extend the protective measures from the signed consent orders for P-25-73, P-25-152, P-25-137, and P-25-151 to any person intending to manufacture, process, use, distribute in commerce, or dispose of the same new chemical substances 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). Any person with an outstanding consent order as of April 24, 2026 for the same new chemical substance may sign it and manufacture, process, use, distribute in commerce, or dispose of the PMN substance consistent with the terms of that order. Any manufacturing, processing, use, distribution in commerce, or disposal of these new chemical substances that does not conform to a signed consent order or occurs in the absence of the protective measures of this SNUR is a significant new use. A SNUN is required prior to any significant new use.
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
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 and environmental release restrictions 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 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
t 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, although several PMNs have been submitted for these same chemical substances, the identities 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.
F. Important Information About SNUN Submissions
1. SNUN Submissions
SNUNs must be submitted on EPA Form No. 7710-25, generated using e-PMN software, and submitted to the Agency in accordance with the procedures set forth in 40 CFR 720.40 and 721.25. E-PMN software is available electronically at https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca.
2
proceed.
F. Important Information About SNUN Submissions
1. SNUN Submissions
SNUNs must be submitted on EPA Form No. 7710-25, generated using e-PMN software, and submitted to the Agency in accordance with the procedures set forth in 40 CFR 720.40 and 721.25. E-PMN software is available electronically at https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca.
2. Development and Submission of Information
EPA recognizes that TSCA section 5 does not require development of any particular new information ( e.g., generating test data) before submission of a SNUN. There is an exception: If a person is required to submit information for a chemical substance pursuant to a rule, order, or consent agreement under TSCA section 4, then TSCA section 5(b)(1)(A) requires such information to be submitted to EPA at the time of submission of the SNUN.
In the absence of a rule, TSCA order, or consent agreement under TSCA section 4 covering the chemical substance, persons are required only to submit information in their possession or control and to describe any other information known to or reasonably ascertainable by them (see 40 CFR 720.50). 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
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(s) (as well as the proposed CFR citation assigned in the regulatory text section of the proposed rule).
• 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
C. Which chemical substances are subject to these proposed SNURs?
The substances subject to the proposed SNURs in this document are identified below with the proposed CFR citation. For each chemical substance, EPA has identified PMNs that were submitted for the chemical substance, although the SNUR will apply to the chemical substance regardless of whether or not a PMN was submitted prior to the issuance of this proposed SNUR.
P-25-73 and P-25-152 (40 CFR 721.12219)
Chemical name: Cobalt lithium manganese nickel oxide, metals-doped (generic).
CASRN: Not available.
Effective date of TSCA Orders: March 16, 2026 (P-25-152) and April 9, 2026 (P-25-73).
Basis for the TSCA Orders: The PMNs state that the generic (non-confidential) use will be in batteries. Multiple PMNs were submitted due to the fact that review of the first PMN received had not yet been completed and the PMN substance was not yet on the inventory
m 3 , then manufacturing, processing, and use must cease;
• Use of personal protective equipment where there is a potential for dermal exposure;
• Use of engineering and administrative control measures to prevent exposure;
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” any use in 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 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.
P-25-137 and P-25-151 (40 CFR 721.12220)
Chemical name: Cobalt lithium manganese nickel oxide, metals-doped (generic).
CASRN: Not available.
Effective date of TSCA Orders: March 16, 2026 (P-25-151) and April 7, 2026 (P-25-137).
Basis for TSCA Orders: The PMNs state that the generic (non-confidential) use will be in batteries. Multiple PMNs were submitted due to the fact that review of the first PMN received had not yet been completed and the PMN substance was not yet on the inventory. The PMN substance is a type of mixed metal oxide that is covered by the analysis EPA conducted that is detailed in the following documents (which are available on thedocket): 1) U.S. EPA. Standardized Scientific Assessment for Mixed Metal Oxide (MMO) Cathode Active Material (CAM) in Battery Applications for Use in TSCA Section 5 New Chemical Reviews, 2026, 2) U.S. EPA
was not yet on the inventory. The PMN substance is a type of mixed metal oxide that is covered by the analysis EPA conducted that is detailed in the following documents (which are available on thedocket): 1) U.S. EPA. Standardized Scientific Assessment for Mixed Metal Oxide (MMO) Cathode Active Material (CAM) in Battery Applications for Use in TSCA Section 5 New Chemical Reviews, 2026, 2) U.S. EPA. Policy on Standardized Scientific Assessment for Mixed Metal Oxide (MMO) Cathode Active Material (CAM) in Battery Applications for Use in TSCA Section 5 New Chemical Review, 2026, and 3) U.S. EPA. Policy on Standardized Risk Management for Mixed Metal Oxide (MMO) Cathode Active Material (CAM) in Battery Applications for Use in TSCA Section 5 New Chemical Reviews), 2026. EPA identified concerns for carcinogenicity, reproductive toxicity, specific target organ toxicity, and dermal and respiratory sensitization, and EPA predicts that toxicity to aquatic organisms may occur at concentrations from 1-5 ppb. To protect against these risks, the Orders require:
• No use of the PMN substance other than in the manufacture of batteries;
• No use of the PMN substance without labeling the exterior of batteries or packaging containing multiple batteries. An example of the label text is as follows: “This battery contains substances that are subject to TSCA restrictions, including for recycling and reclamation activities. For details, contact the battery manufacturer or the EPA TSCA hotline.”;
• No manufacturing, processing (all processing includes recycling or reclaiming substances from batteries or other items containing the PMN substance) or use of the PMN substance except with the use of dust controls with an overall minimum combined capture and control efficiency of 99%;
• No release of the PMN substance to the air at a single site such that the rolling average concentration over 14 days at the property boundary would be more than a maximum of 1.3E-4 mg/m 3 of the PMN substance individually or in any combination ( i.e., in
nce) or use of the PMN substance except with the use of dust controls with an overall minimum combined capture and control efficiency of 99%;
• No release of the PMN substance to the air at a single site such that the rolling average concentration over 14 days at the property boundary would be more than a maximum of 1.3E-4 mg/m 3 of the PMN substance individually or in any combination ( i.e., in aggregate) with other cobalt containing mixed metal oxide (MMO) chemical substances;
• No manufacture or processing of the PMN substance for more than one year unless there is no air release of the PMN substance or the air release limit is updated;
• No manufacture or processing of the PMN substance for more than one year unless there is no inhalation exposure to the PMN substance or the Respiratory Protection Limits are updated;
• No disposal of the PMN substance, or any waste stream containing the PMN substance, other than by hazardous waste landfill in compliance with the Resource Conservation and Recovery Act Subtitle C or incineration if the incinerator ash is disposed of by hazardous waste landfill in compliance with the Resource Conservation and Recovery Act Subtitle C;
• No release of the PMN substance, or any waste stream containing the PMN substance, to water;
• Prior to worker exposure monitoring—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 to workers.
• Upon exposure monitoring results—use of a NIOSH-certified respirator with an APF in accordance with the below Respiratory Protection Limits, provided that an APF below 50 is only permitted when the PMN substance contains less than or equal to 3% cobalt by weight. If the 8-Hour Time Weighted Average (TWA) is less than 5.3E-4 mg/m 3 , no respiratory protection is required
on exposure to workers.
• Upon exposure monitoring results—use of a NIOSH-certified respirator with an APF in accordance with the below Respiratory Protection Limits, provided that an APF below 50 is only permitted when the PMN substance contains less than or equal to 3% cobalt by weight. If the 8-Hour Time Weighted Average (TWA) is less than 5.3E-4 mg/m 3 , no respiratory protection is required. If the 8-Hour TWA is more than or equal to 5.3E-4 mg/m 3 but less than 5.3E-3 mg/m 3 , respiratory protection with a minimum APF of 10 is required. If the 8-Hour TWA is more than or equal to 5.3E-3 mg/m 3 but less than 2.7E-2 mg/m 3 , respiratory protection with a minimum APF of 50 is required. If the 8-Hour TWA is more than or equal to 2.7E-2 mg/m 3 but less than 5.3E-1 mg/m 3 , respiratory protection with a minimum APF of 1000 is required. If the 8-Hour TWA is more than or equal to 5.3E-1 mg/m 3 but less than 5.3E+00 mg/m 3 , respiratory protection with a minimum APF of 10,000 is required. If the 8-Hour TWA exceeds 5.3E+00 mg/m 3 , then manufacturing, processing, and use must cease;
• Use of personal protective equipment where there is a potential for dermal exposure;
• Use of engineering and administrative control measures to prevent exposure; 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” any use in 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 substances
hat 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 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.
IV. Statutory and Executive Order Reviews
Additional information about these statutes and Executive orders can be found at https://www.epa.gov/laws-regulations/laws-and-executive-orders.
A. Executive Order 12866: Regulatory Planning and Review
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).
B. Executive Order 14192: Unleashing Prosperity Through Deregulation
Executive Order 14192 (90 FR 9065, February 6, 2025) does not apply because significant new use rules for new chemicals under TSCA section 5 are exempted from review under Executive Order 12866.
C. Paperwork Reduction Act (PRA)
According to the PRA (44 U.S.C. 3501 et 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
rson 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).
EPA always welcomes feedback on the burden estimates. When submitting comments on these proposed SNURs, include comments about the accuracy of the burden estimate, and any suggested methods for improving the collection instruments or instruction or minimizing respondent burden, including through the use of automated collection techniques.
D. Regulatory Flexibility Act (RFA)
I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA (5 U.S.C. 601 et seq. ). The requirement to submit a SNUN applies to any person (including small or large entities) who intends to engage in any activity described in the final rule as a “significant new use.” Because these uses are “new,” based on all information currently available to EPA, EPA has concluded that no small or 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
in such activity in the future must first notify EPA by submitting a SNUN. Although some small entities may decide to pursue a significant new use in the future, EPA cannot presently determine how many, if any, there may be. However, EPA's experience to date is that, in response to the promulgation of SNURs covering over 1,000 chemicals, the Agency receives only a small number of notices per year. For example, the number of SNUNs received was 9 in fiscal year FY2022, 23 in FY2023, and 7 in FY2024, and only a fraction of these submissions 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 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
ustrial, commercial, and consumer use section. The article exemption applies unless/until the article has been shredded or processed such that dust is generated. Once the article containing the substance is or has been shredded or otherwise handled such that there is potential for exposure to or release of the substance, the article exemption no longer applies.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(3) through (6), and (c). When determining whichpersons 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., workplacepolicies andprocedures) shall be considered and implemented toprevent exposure, where feasible. Forpurposes of § 721.63(a)(5), respirators mustprovide a National Institute for Occupational Safety and Health (NIOSH) assignedprotection factor (APF) of at least 1,000prior to the receipt of exposure monitoring results andin accordance withthe following Respiratory Protection Limits once exposure monitoring results are available. An APF below 50 is only permitted if the PMN substance contains less than or equal to 3% cobalt by weight. If the 8-Hour Time Weighted Average (TWA) is less than 5.3E-4 mg/m 3 , no respiratoryprotection isrequired. If the 8-Hour TWA is more than or equal to 5.3E-4 mg/m 3 but less than 5.3E-3 mg/m 3 , respiratory protection with a minimum APF of 10 isrequired. If the 8-Hour TWA is more than or equal to 5.3E-3 mg/m 3 but less than 2.7E-2 mg/m 3 , respiratoryprotection with a minimum APF of 50 isrequired. If the 8-Hour TWA is more than or equal to 2.7E-2 mg/m 3 but less than 5.3E-1 mg/m 3 , respiratoryprotection with a minimum APF of 1000 isrequired. If the 8-Hour TWA is more than or equal to 5.3E-1 mg/m 3 but less than 5.3E+00 mg/m 3 , respiratoryprotection with a minimum APF of 10,000 isrequired
5.3E-3 mg/m 3 but less than 2.7E-2 mg/m 3 , respiratoryprotection with a minimum APF of 50 isrequired. If the 8-Hour TWA is more than or equal to 2.7E-2 mg/m 3 but less than 5.3E-1 mg/m 3 , respiratoryprotection with a minimum APF of 1000 isrequired. If the 8-Hour TWA is more than or equal to 5.3E-1 mg/m 3 but less than 5.3E+00 mg/m 3 , respiratoryprotection with a minimum APF of 10,000 isrequired. If the 8-Hour TWA exceeds 5.3E+00 mg/m 3 , then manufacturing,processing, and use must cease.
(ii) Hazard communication. Requirements as specified in § 721.72(a) through (d), (f), (g)(1), (g)(3)(iii), and (g)(5). Forpurposes of § 721.72(g)(1), this substance may cause: carcinogenicity, genetic toxicity, skin sensitization, respiratory sensitization, reproductive toxicity, neurotoxicity, 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 use. It is a significant new use to manufacture or process the substance for more than one year if there is any release of the substance to air or inhalation exposure to workers. It is a significant new use to use the substance other than as a substance for use in the manufacture of batteries. It is a significant new use to manufacture, process (all processing includes recycling or reclaiming substances from batteries or other items containing the PMN substance), or use the substance, except with the use of dust controls with an overall minimum capture and control efficiency of 99%
ignificant new use to use the substance other than as a substance for use in the manufacture of batteries. It is a significant new use to manufacture, process (all processing includes recycling or reclaiming substances from batteries or other items containing the PMN substance), or use the substance, except with the use of dust controls with an overall minimum capture and control efficiency of 99%. It is a significant new use to use the substance without labeling the exterior of batteries or the exterior of packaging containing multiple batteries to indicate that they contain a substance that is subject to restrictions under TSCA, including during recycling, consistent with all of the following conditions:
(A) The battery label shall be placed directly on the visible exterior of the wrappings and packaging in which the battery is placed for sale, shipment, or storage. An example of the text on the battery label is as follows: “This battery contains substances that are subject to TSCA restrictions, including for recycling and reclamation activities. For details, contact the battery manufacturer or the EPA TSCA Hotline.”
(B) Any batteries distributed in commerce without packaging or wrapping must be labeled or tagged directly on the visible exterior surface.
(C) Battery labels must be sufficiently durable to equal or exceed the life of the battery and attached in such a manner that they cannot be removed without defacing or destroying them.
(D) Any battery repackaging must ensure that the battery label remains visible or that a new battery label or tag is placed on the visible exterior.
(iv) Disposal. It is a significant new use to dispose of the substance or waste streams containing the substance other than by hazardous waste landfill in compliance with the Resource Conservation and Recovery Act Subtitles C or incineration, where the incinerator ash must be disposed of by hazardous waste landfill in compliance with the Resource Conservation and Recovery Act Subtitle C.
and P-25-151) 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 the substance has been incorporated into an “article” as defined at 40 CFR 720.3, except as to the battery labeling requirements in the Industrial, commercial, and consumer use section. The article exemption applies unless/until the article has been shredded or processed such that dust is generated. Once the article containing the substance is or has been shredded or otherwise handled such that there is potential for exposure to or release of the substance, the article exemption no longer applies.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(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 prior to the receipt of exposure monitoring results and in accordance with the following Respiratory Protection Limits once exposure monitoring results are available. An APF below 50 is only permitted if the PMN substance contains less than or equal to 3% cobalt by weight. If the 8-Hour Time Weighted Average (TWA) is less than 5.3E-4 mg/m 3 , no respiratory protection is required. If the 8-Hour TWA is more than or equal to 5.3E-4 mg/m 3 but less than 5.3E-3 mg/m 3 , respiratory protection with a minimum APF of 10 is required
, (g)(1), (g)(3)(iii), and (g)(5). For purposes of § 721.72(g)(1), this substance may cause: carcinogenicity, genetic toxicity, skin sensitization, respiratory sensitization, reproductive toxicity, neurotoxicity, 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 use. It is a significant new use to manufacture or process the substance for more than one year if there is any release of the substance to air or inhalation exposure to workers. It is a significant new use to use the substance other than as a substance for use in the manufacture of batteries. It is a significant new use to manufacture, process (all processing includes recycling or reclaiming substances from batteries or other items containing the PMN substance), or use the substance, except with the use of dust controls with an overall minimum capture and control efficiency of 99%. It is a significant new use to use the substance without labeling the exterior of batteries or the exterior of packaging containing multiple batteries to indicate that they contain a substance that is subject to restrictions under TSCA, including during recycling, consistent with all of the following conditions:
(A) The battery label shall be placed directly on the visible exterior of the wrappings and packaging in which the battery is placed for sale, shipment, or storage. An example of the text on the battery label is as follows: “This battery contains substances that are subject to TSCA restrictions, including for recycling and reclamation activities. For details, contact the battery manufacturer or the EPA TSCA Hotline.”
(B) Any batteries distributed in commerce without packaging or wrapping must be labeled or tagged directly on the visible exterior surface

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/FR_PRORULE_2026-08012. Check the current official text before relying on it. Not legal advice.