[Federal Register Volume 91, Number 79 (Friday, April 24, 2026)]
[Proposed Rules]
[Pages 22075-22083]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2026-08012]
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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.
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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. NW, Washington, DC 20460-
0001; telephone number: (202) 564-2138; email address:
[email protected].
For general information on SNURs: William Wysong, New Chemicals
Division (7405M), Office of Pollution
[[Page 22076]]
Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number:
(202) 564-4163; email address: [email protected].
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: [email protected].
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.
2. Applicability to Importers and Exporters
This action may also apply to certain entities through pre-existing
import certification and export notification requirements under TSCA
(https://www.epa.gov/tsca-import-export-requirements).
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 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. 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?
1. Submitting CBI
Do not submit CBI to EPA through email or https://www.regulations.gov. If you wish to include CBI in your comment, please
follow the applicable instructions at https://www.epa.gov/dockets/commenting-epa-dockets#rules and clearly mark the information that you
claim to be CBI. Information so marked will not be disclosed except in
accordance with procedures set forth in 40 CFR parts 2 and 703.
2. Tips for Preparing Your Comments
When preparing and submitting your comments, see the commenting
tips at https://www.epa.gov//epa-dockets.
II. Background
This unit provides general information about SNURs. For additional
information about EPA's new chemical program go to https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca.
A. Significant New Use Determination Factors
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
[[Page 22077]]
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. 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.
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.
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 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.
[[Page 22078]]
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,
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. 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. 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 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 April 24, 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(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
[[Page 22079]]
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
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. 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 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. 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. 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).
[[Page 22080]]
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. 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 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. 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. 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.
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).
[[Page 22081]]
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 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. 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. In
addition, the estimated costs of this action to the private sector do
not exceed $183 million or more in any one year (the 1995 dollars are
adjusted to 2023 dollars for inflation using the GDP implicit price
deflator). The estimated costs for this action are discussed in Unit
I.D.
F. Executive Order 13132: Federalism
This action will not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999), because it is not
expected to have a substantial direct effect on States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. Accordingly, the requirements of Executive Order 13132 do
not apply to this action.
G. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments
This action will not have Tribal implications as specified in
Executive Order 13175 (65 FR 67249, November 9, 2000), because it is
not expected to have substantial direct effects on Indian Tribes,
significantly or uniquely affect the communities of Indian Tribal
governments and does not involve or impose any requirements that affect
Indian Tribes. Accordingly, the requirements of Executive Order 13175
do not apply to this action.
H. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks
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 2026 Policy on Children's Health also does not apply. Although
the establishment of these SNURs do not address an existing children's
environmental health concern because the chemical uses involved are not
ongoing uses, SNURs require that persons notify EPA at least 90 days
before commencing manufacture (defined by statute to include import) or
processing of the identified chemical substances for an activity that
is designated as a significant new use by the SNUR. This notification
allows EPA to assess the intended uses to identify potential risks and
take appropriate actions before the activities commence.
I. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use
This action is not a ``significant energy action'' as defined in
Executive Order 13211 (66 FR 28355, May 22, 2001), because it is not
likely to have a significant adverse effect on the supply,
distribution, or use of energy.
J. National Technology Transfer and Advancement Act (NTTAA)
This action does not involve any technical standards subject to
NTTAA section 12(d) (15 U.S.C. 272 note).
List of Subjects in 40 CFR part 721
Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.
Dated: April 21, 2026.
Mary Elissa Reaves,
Director, Office of Pollution Prevention and Toxics.
For the reasons stated in the preamble, EPA proposes to amend 40
CFR chapter I as follows:
PART 721--SIGNIFICANT NEW USES OF CHEMICAL SUBSTANCES
0
1. The authority citation for part 721 continues to read as follows:
Authority: 15 U.S.C. 2604, 2607, and 2625(c).
0
2. Add Sec. Sec. 721.12219 through 721.12220 to subpart E to read as
follows:
Subpart E--Significant New Uses for Specific Chemical Substances
* * * * *
Sec.
721.12219 Cobalt lithium manganese nickel oxide, metals-doped
(generic).
[[Page 22082]]
721.12220 Cobalt lithium manganese nickel oxide, metals-doped
(generic).
Sec. 721.12219 Cobalt lithium manganese nickel oxide, metals-doped
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as cobalt
lithium manganese nickel oxide, metals-doped (PMNs P-25-73 and P-25-
152) 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 Sec.
721.63(a)(1), (a)(3) through (6), and (c). When determining
whichpersons are reasonably likely to be exposed as required for Sec.
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 Sec. 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. 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 Sec.
721.72(a) through (d), (f), (g)(1), (g)(3)(iii), and (g)(5).
Forpurposes of Sec. 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.
(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.
(v) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1).
(vi) Release to air. It is a significant new use to release the
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 substance individually or in any
combination (i.e., in aggregate) with other cobalt containing mixed
metal oxide (MMO) chemical substances.
(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 Sec.
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 Sec. 721.185 apply to this section.
Sec. 721.12220 Metal cobalt lithium manganese nickel oxide, metals-
doped (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as metal
cobalt lithium manganese nickel oxide, metals-doped (PMNs P-25-137 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:
[[Page 22083]]
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(3) through (6), and (c). When determining which
persons are reasonably likely to be exposed as required for Sec.
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 Sec. 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. 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.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), (g)(3)(iii), and (g)(5). For
purposes of Sec. 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.
(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.
(v) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1).
(vi) Release to air.It is a significant new use to release the
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 substance individually or in any
combination (i.e., in aggregate) with other cobalt containing mixed
metal oxide (MMO) chemical substances.
(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 Sec.
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 Sec. 721.185 apply to this section.
[FR Doc. 2026-08012 Filed 4-23-26; 8:45 am]
BILLING CODE 6560-50-P