Proposed Rule2026-11319
Significant New Use Rules on Certain Chemical Substances (25-3.5e)
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
June 5, 2026
Issuing agencies
Environmental Protection Agency
Abstract
EPA is proposing significant new use rules (SNURs) under the Toxic Substances Control Act (TSCA) for certain chemical substances that were the subject of premanufacture notices (PMNs) and are also subject to an Order issued by EPA pursuant to TSCA. The SNURs require persons who intend to manufacture (defined by statute to include import) or process any of these chemical substances for an activity that is proposed as a significant new use by this rulemaking to notify EPA at least 90 days before commencing that activity. The required notification initiates EPA's evaluation of the conditions of that use for that chemical substance. In addition, the manufacture or processing for the significant new use may not commence until EPA has conducted a review of the required notification, made an appropriate determination regarding that notification, and taken such actions as required by that determination.
Full Text
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[Federal Register Volume 91, Number 108 (Friday, June 5, 2026)]
[Proposed Rules]
[Pages 34480-34509]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-11319]
[[Page 34479]]
Vol. 91
Friday,
No. 108
June 5, 2026
Part III
Environmental Protection Agency
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40 CFR Part 721
Significant New Use Rules on Certain Chemical Substances (25-3.5e);
Proposed Rule
Federal Register / Vol. 91 , No. 108 / Friday, June 5, 2026 /
Proposed Rules
[[Page 34480]]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[EPA-HQ-OPPT-2025-2169; FRL-13126-01-OCSPP]
RIN 2070-AB27
Significant New Use Rules on Certain Chemical Substances (25-
3.5e)
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: EPA is proposing significant new use rules (SNURs) under the
Toxic Substances Control Act (TSCA) for certain chemical substances
that were the subject of premanufacture notices (PMNs) and are also
subject to an Order issued by EPA pursuant to TSCA. The SNURs require
persons who intend to manufacture (defined by statute to include
import) or process any of these chemical substances for an activity
that is proposed as a significant new use by this rulemaking to notify
EPA at least 90 days before commencing that activity. The required
notification initiates EPA's evaluation of the conditions of that use
for that chemical substance. In addition, the manufacture or processing
for the significant new use may not commence until EPA has conducted a
review of the required notification, made an appropriate determination
regarding that notification, and taken such actions as required by that
determination.
DATES: Comments must be received on or before July 6, 2026.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2025-2169, online at <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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 <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
FOR FURTHER INFORMATION CONTACT: For technical information: Joseph
Said, New Chemicals Division (7405M), Office of Pollution Prevention
and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW,
Washington, DC 20460-0001; telephone number: (202) 566-0848; email
address: <a href="/cdn-cgi/l/email-protection#0c7f6d65682266637f697c644c697c6d226b637a"><span class="__cf_email__" data-cfemail="84f7e5ede0aaeeebf7e1f4ecc4e1f4e5aae3ebf2">[email protected]</span></a>.
For general information on SNURs: William Wysong, New Chemicals
Division (7405M), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; telephone number: (202) 564-4163; email address:
<a href="/cdn-cgi/l/email-protection#daada3a9b5b4bdf4adb3b6b6b3bbb79abfaabbf4bdb5ac"><span class="__cf_email__" data-cfemail="f6818f85999891d8819f9a9a9f979bb6938697d8919980">[email protected]</span></a>.
For general information on TSCA: The TSCA Assistance Information
Service Hotline, Goodwill of the Finger Lakes, 422 South Clinton Ave.,
Rochester, NY 14620; telephone number: (800) 471-7127 or (202) 554-
1404; email address: <a href="/cdn-cgi/l/email-protection#b9edeafaf894f1d6cdd5d0d7dcf9dcc9d897ded6cf"><span class="__cf_email__" data-cfemail="2c787f6f6d01644358404542496c495c4d024b435a">[email protected]</span></a>.
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:
<bullet> 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 Eexporters
This action may also apply to certain entities through pre-existing
import certification and export notification requirements under TSCA
(<a href="https://www.epa.gov/tsca-import-export-requirements">https://www.epa.gov/tsca-import-export-requirements</a>).
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 part 707, subpart B. Importers of chemical substances in bulk form,
as part of a mixture, or as part of an article (if required by rule)
must certify that the shipment of the chemical substance complies with
all applicable rules and Orders under TSCA, including regulations
issued under TSCA sections 5, 6, 7 and Title IV.
Pursuant to 40 CFR 721.20, any persons who export or intend to
export a chemical substance that is the subject of this proposed rule
on or after July 6, 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 these
proposed SNURs. This analysis, which is available in the docket, is
briefly summarized here.
1. Estimated Costs for SNUN Submissions
If a SNUN is submitted, costs are an estimated $45,496 per SNUN
submission for large business submitters and $14,976 for small business
submitters. These estimates include the cost to prepare and submit the
SNUN (including registration for EPA's Central 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 Ccosts 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
[[Page 34481]]
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. If you wish to include CBI in your comment, please
follow the applicable instructions at <a href="https://www.epa.gov/dockets/commenting-epa-dockets#rules">https://www.epa.gov/dockets/commenting-epa-dockets#rules</a> 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 <a href="https://www.epa.gov//epa-dockets">https://www.epa.gov//epa-dockets</a>.
II. Background
This unit provides general information about SNURs. For additional
information about EPA's new chemical program go to <a href="https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca">https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca</a>.
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:
<bullet> The projected volume of manufacturing and processing of a
chemical substance.
<bullet> The extent to which a use changes the type or form of
exposure of human beings or the environment to a chemical substance.
<bullet> The extent to which a use increases the magnitude and
duration of exposure of human beings or the environment to a chemical
substance.
<bullet> The reasonably anticipated manner and methods of
manufacturing, processing, distribution in commerce, and disposal of a
chemical substance.
In determining what would constitute a significant new use for the
chemical substances that are the subject of these SNURs, EPA considered
relevant information about the toxicity of the chemical substances, and
potential human exposures and environmental releases that may be
associated with the substances, in the context of the four bulleted
TSCA section 5(a)(2) factors listed in this unit and discussed in Unit
III.
These proposed SNURs include PMN substances that are subject to
Orders issued under TSCA section 5(e)(1)(A), as required by the
determinations made under TSCA section 5(a)(3)(B). The 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).
B. Rationale and Objectives of the SNURs
1. Rationale
Under TSCA, no person may manufacture a new chemical substance or
manufacture or process a chemical substance for a significant new use
until EPA makes a determination as described in TSCA section 5(a) and
takes any required action. The issuance of a SNUR is not a risk
determination itself, only a notification requirement for ``significant
new uses,'' so that the Agency has the opportunity to review the SNUN
for the significant new use and make a TSCA section 5(a)(3) risk
determination.
During review of the PMNs submitted that are subject to these
proposed SNURs, EPA concluded that regulation was warranted under TSCA
section 5(e), pending the development of information sufficient to make
reasoned evaluations of the health or environmental effects of the
chemical substances. Based on the findings outlined in Unit III., TSCA
section 5(e) Orders requiring the use of appropriate exposure controls
were negotiated with the PMN submitters. As a general matter, EPA
believes it is necessary to follow the TSCA Orders 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
original submitter--are held to the same standard.
2. Objectives
EPA is proposing these SNURs because the Agency has determined it
is appropriate:
<bullet> 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).
<bullet> 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.
<bullet> 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.
[[Page 34482]]
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), (2),
(3), and (5) and the regulations at 40 CFR part 720. In addition,
provisions relating to user fees appear at 40 CFR part 700.
Once EPA receives a SNUN, EPA must either determine that the
significant new use is not likely to present an unreasonable risk of
injury under the conditions of use for the chemical substance or take
such regulatory action as is associated with an alternative
determination under TSCA section 5 before the manufacture (including
import) or processing for the significant new use can commence. If EPA
determines that the significant new use of the chemical substance is
not likely to present an unreasonable risk, EPA is required under TSCA
section 5(g) to make public, and submit for publication in the Federal
Register, a statement of EPA's findings.
As discussed in Unit I.C.2., persons who export or intend to export
a chemical substance identified in a proposed or final SNUR are subject
to the export notification provisions of TSCA section 12(b), and
persons who import a chemical substance identified in a final SNUR are
subject to the TSCA section 13 import certification requirements. See
also <a href="https://www.epa.gov/tsca-import-export-requirements">https://www.epa.gov/tsca-import-export-requirements</a>.
E. Applicability of the Proposed SNURs to Uses Occurring Before the
Effective Date of the Final Rule
To establish a significant new use, EPA must determine that the use
is not ongoing. The chemical substances subject to this proposed rule
have undergone premanufacture review and received determinations under
TSCA section 5(a)(3)(C). TSCA Orders have been issued for these
chemical substances and the PMN submitters are required by the TSCA
Orders to submit a SNUN before undertaking activities that would be
designated as significant new uses in these SNURs. Additionally, the
identities of many of the chemical substances subject to this proposed
rule have been claimed as confidential per 40 CFR 720.85, further
reducing the likelihood that another party would manufacture or process
the substances for an activity that would be designated as a
significant new use. Based on this, the Agency believes that it is
highly unlikely that any of the significant new uses identified in Unit
III. are ongoing.
When the chemical substances identified in Unit III. are added to
the TSCA Inventory, EPA recognizes that, before the rule is effective,
other persons might engage in a use that has been identified as a
significant new use. Persons who begin manufacture or processing of the
chemical substances for a significant new use identified on or after
the designated cutoff date specified in Unit III.A. would have to cease
any such activity upon the effective date of the final rule. To resume
their activities, these persons would have to first comply with all
applicable SNUR notification requirements and EPA would have to take
action under TSCA section 5 allowing manufacture or processing to
proceed.
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 <a href="https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca">https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca</a>.
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 <a href="https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/alternative-test-methods-and-strategies-reduce">https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/alternative-test-methods-and-strategies-reduce</a>.
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 June 5, 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:
<bullet> PMN number (the proposed CFR citation assigned in the
regulatory text section of the proposed rule).
[[Page 34483]]
<bullet> Chemical name (generic name, if the specific name is
claimed as CBI).
<bullet> Chemical Abstracts Service Registry Number (CASRN) or
Accession Number (if assigned for confidential chemical identities).
<bullet> Basis for the SNUR (e.g., effective date of and basis for
the TSCA Order).
<bullet> Potentially useful information.
The regulatory text section of the proposed rule specifies the
activities designated as significant new uses. Certain new uses,
including production volume limits and other uses designated in the
proposed rules, may be claimed as CBI.
These proposed SNURs include PMN substances that are subject to
Orders issued under TSCA section 5(e)(1)(A), as required by the
determinations made under TSCA section 5(a)(3)(B). Those TSCA Orders
require protective measures to limit exposures or otherwise mitigate
the potential unreasonable risk. The proposed SNURs identify as
significant new uses any manufacturing, processing, use, distribution
in commerce, or disposal that does not conform to the restrictions
imposed by the underlying TSCA Orders, consistent with TSCA section
5(f)(4).
Where EPA determined that the PMN substance may present an
unreasonable risk of injury to human health via inhalation exposure,
the underlying TSCA Order usually requires that potentially exposed
employees wear specified respirators unless actual measurements of the
workplace air show that air-borne concentrations of the PMN substance
are below a New Chemical Exposure Limit (NCEL). The comprehensive NCELs
provisions in TSCA Orders include requirements addressing performance
criteria for sampling and analytical methods, periodic monitoring,
respiratory protection, and recordkeeping. No comparable NCEL
provisions currently exist for SNURs in 40 CFR part 721, subpart B.
Therefore, for these cases, the individual SNURs in 40 CFR part 721,
subpart E, will state that persons subject to the SNUR who wish to
pursue NCELs as an alternative to the 40 CFR 721.63 respirator
requirements may request to do so under 40 CFR 721.30. EPA expects that
persons whose 40 CFR 721.30 requests to use the NCELs approach for
SNURs that are approved by EPA will be required to comply with NCELs
provisions that are comparable to those contained in the corresponding
TSCA Order.
C. Which chemical substances are subject to these proposed SNURs?
The substances subject to the proposed SNURs in this document are
as follows, listed by PMN number and with the proposed CFR citation:
P-21-76 (40 CFR 721.12225)
Chemical Name: Alcohols, C16-18 and C18-unsatd., reaction products
with substituted alkyloxirane and alkyl acid (generic).
CASRN or Accession No.: Not available.
Effective Date of TSCA Order: August 26, 2025.
Basis for TSCA Order: The PMN states that the use will be as an
additive for fluids used in oil drilling operations. Based on submitted
test data on the PMN substance, EPA has identified concerns for skin
sensitization and systemic effects. The Order was issued under TSCA
sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding
that in the absence of sufficient information to permit a reasoned
evaluation, the substance may present an unreasonable risk of injury to
human health. To protect against these risks, the Order requires:
<bullet> Use of personal protective equipment where there is a
potential for dermal exposure;
<bullet> No manufacture, processing, or use of the PMN substance in
any manner that results in inhalation exposure;
<bullet> No use of the PMN substance in a consumer product; and
<bullet> Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of
systemic toxicity testing may be potentially useful to characterize the
health effects of the PMN substance. Although the Order does not
require these tests, the Order's restrictions remain in effect until
the Order is modified or revoked by EPA based on submission of this or
other relevant information.
P-22-40 (40 CFR 721.12226)
Chemical Name: Manganate(4-), hexakis(cyano-.kappa.C)-,
manganese(2+) sodium, (OC-6-11)-.
CASRN: 2073840-04-5.
Effective Date of TSCA Order: August 25, 2025.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as a component used in manufacture of high-
performance batteries. Based on comparison to analogous chemical
substances and information for other poorly soluble respirable
particles, EPA has identified concerns for lung effects (lung
overload). Based on comparison to analogous chemical substances and
components of the PMN substance, EPA has also identified concerns for
acute toxicity, skin sensitization, and reproductive and systemic
effects. Based on submitted test data on the PMN substance and
comparison to analogous chemical substances, EPA predicts toxicity to
aquatic organisms may occur at concentrations that exceed 0.2 ppb. The
Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and
5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient
information to permit a reasoned evaluation, the substance may present
an unreasonable risk of injury to human health and the environment. To
protect against these risks, the Order requires:
<bullet> Use of personal protective equipment where there is a
potential for dermal exposure;
<bullet> Use of a NIOSH-certified respirator with an APF of at
least 1000 where there is a potential for inhalation exposure;
<bullet> Manufacturing and processing of the PMN substance only in
an enclosed process. The process remains enclosed as long as the only
releases are from sampling, dust filter changes, loss of integrity, or
failure of the manufacturing process equipment or control systems;
<bullet> Dust filter changes may be performed no more than two
times a year;
<bullet> At each site that the PMN substance is manufactured that
has off-gas waste streams, all such waste streams must be captured and
routed through engineering controls that achieve a total combined
efficiency of 99.9% destruction of the PMN substance;
<bullet> Manufacture of the PMN substance only if the concentration
of manganese does not exceed the confidential percentage by weight
listed in the Order;
<bullet> No use of the PMN substance in any manner that results in
inhalation exposure to workers;
<bullet> Use of the PMN substance only as a component in
manufacture of high performance batteries;
<bullet> When the PMN substance is in solid form the PMN substance
may be disposed of by landfill. Landfill disposal
[[Page 34484]]
of the PMN substance must be at a hazardous waste landfill facility
that is in compliance with RCRA subtitle C and D. Otherwise the PMN
substance, or waste streams containing the PMN substance, must be
disposed of by incineration. Disposal of the PMN substance by
incineration must not exceed the confidential annual limit listed in
the Order however the limit does not apply to quantities sent for
incineration at a hazardous waste incineration facility that is
compliant with RCRA subtitle C;
<bullet> No release of the PMN substance, or any waste stream
containing the PMN substance, resulting in surface water concentrations
that exceed 0.2 ppb; and
<bullet> Establishment of a hazard communication program, including
human health and environmental precautionary statements on each label
and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of
specific target organ toxicity, pulmonary effects, reproductive
toxicity, neurotoxicity, and aquatic toxicity testing may be
potentially useful to characterize the health and environmental effects
of the PMN substance. Although the Order does not require these tests,
the Order's restrictions remain in effect until the Order is modified
or revoked by EPA based on submission of this or other relevant
information.
P-22-41 (40 CFR 721.12227)
Chemical Name: Ferrate(4-), hexakis(cyano-.kappa.C)-, iron(3+)
manganese(2+) sodium, (OC-6-11)-.
CASRN: 2073839-30-0.
Effective Date of TSCA Order: August 25, 2025.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as a component used in manufacture of high-
performance batteries. Based on comparison to analogous chemical
substances and information for other poorly soluble respirable
particles, EPA has identified concerns for lung effects (lung
overload). Based on comparison to analogous chemical substances, EPA
has also identified concerns for skin sensitization and acute,
reproductive, and systemic effects. Based on submitted test data on the
PMN substance and comparison to analogous chemical substances, EPA
predicts toxicity to aquatic organisms may occur at concentrations that
exceed 2 ppb. The Order was issued under TSCA sections
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the
absence of sufficient information to permit a reasoned evaluation, the
substance may present an unreasonable risk of injury to human health
and the environment. To protect against these risks, the Order
requires:
<bullet> Use of personal protective equipment where there is a
potential for dermal exposure;
<bullet> Use of a NIOSH-certified respirator with an APF of at
least 10 where there is a potential for inhalation exposure;
<bullet> Manufacturing and processing of the PMN substance only in
an enclosed process. The process remains enclosed as long as the only
releases are from sampling, dust filter changes, loss of integrity, or
failure of the manufacturing process equipment or control systems;
<bullet> Dust filter changes may be performed no more than two
times a year;
<bullet> At each site that the PMN substance is manufactured that
has off-gas waste streams, all such waste streams must be captured and
routed through engineering controls that achieve a total combined
efficiency of 99.9% destruction of the PMN substance;
<bullet> Manufacture of the PMN substance only if the concentration
of manganese does not exceed the confidential percentage by weight
listed in the Order;
<bullet> No use of the PMN substance in any manner that results in
inhalation exposure to workers;
<bullet> Use of the PMN substance only as a component in
manufacture of high performance batteries;
<bullet> When the PMN substance is in solid form the PMN substance
may be disposed of by landfill. Landfill disposal of the PMN substance
must be at a hazardous waste landfill facility that is in compliance
with RCRA subtitle C and D. Otherwise the PMN substance, or waste
streams containing the PMN substance, must be disposed of by
incineration. Disposal of the PMN substance by incineration must not
exceed the confidential annual limit listed in the Order however the
limit does not apply to quantities sent for incineration at a hazardous
waste incineration facility that is compliant with RCRA subtitle C;
<bullet> No release of the PMN substance, or any waste stream
containing the PMN substance, resulting in surface water concentrations
that exceed 2.0 ppb; and
<bullet> Establishment of a hazard communication program, including
human health and environmental precautionary statements on each label
and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of
specific target organ toxicity, pulmonary effects, reproductive
toxicity, neurotoxicity, and aquatic toxicity testing may be
potentially useful to characterize the health and environmental effects
of the PMN substance. Although the Order does not require these tests,
the Order's restrictions remain in effect until the Order is modified
or revoked by EPA based on submission of this or other relevant
information.
P-22-158 (40 CFR 721.12228)
Chemical Names: 1H,4H,14H,17H-2,16:3,15-Dimethano-
5H,6H,7H,8H,9H,10H,11H,12H,13H,18H,19H,20H,21H,22H,23H,24H,25H,26H-
2,3,4a,5a,6a,7a,8a,9a,10a,11a,12a,13a,15,16,17a,18a,19a,20a,21a,22a,23a,
24a,25a,26a-
tetracosaazabispentaleno[1''',6''':5',6',7']cycloocta[1'',2'',3'''':3',4
']pentaleno[1',6'':5,6'',7]cycloocta[1,2,3-gh:1',2',3'-
g'h']cycloocta[1,2,3-cd:5,6,7-c'd']dipentalene-
1,4,6,8,10,12,14,17,19,21,23,25-dodecone, dodecahydro-, stereoisomer;
2,18:3,17-Dimethano-
2,3,4a,5a,6a,7a,8a,9a,10a,11a,12a,13a,14a,15a,17,18,19a,20a,21a,22a,23a,
24a,25a,26a,27a,28a,29a,30a-
octacosaazabispentaleno[1''''',6''''':5'''',
6'''',7'''']cycloocta[1'''',2'''',3'''':3''',4''']pentaleno[1''',6''':5'
',6'',7'']cycloocta[1'',2'',3'':3',4']pentaleno[1',6':5,6,7]cycloocta[1,
2,3-cd:1',2',3'-gh]pentalene-1,4,6,8,10,12,14,16,19,21,23,25,27,29-
tetradecone, tetradecahydro-, stereoisomer; 2,20:3,19-Dimethano-
2,3,4a,5a,6a,7a,8a,9a,10a,11a,12a,13a,14a,15a,16a,17a,19,20,21a,22a,23a,
24a,25a,26a,27a,28a,29a,30a,31a,32a,33a,34a-
dotriacontaazabispentaleno[1''''',6''''':5'''',6'''',7'''']cycloocta[1''
'',2'''',3'''':3''',4''']pentaleno[1''',6''':5'',6'',7'']cycloocta[1'',2
'',3'':3',4']pentaleno[1',6':5,6,7]cycloocta[1,2,3-gh:1',2',3'-
g'h']cycloocta[1,2,3-cd:5,6,7-
[[Page 34485]]
c'd']dipentalene-1,4,6,8,10,12,14,16,18,21,23,25,27,29,31,33-
hexadecone, hexadecahydro-, stereoisomer.
CASRNs: 283175-97-3, 259886-50-5, and 259886-51-6.
Effective Date of TSCA Order: June 18, 2025.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as an additive used in consumer, commercial,
and industrial applications. Based on submitted test data on the PMN
substances, EPA predicts toxicity to aquatic organisms may occur at
concentrations that exceed 18 ppb. The Order was issued under TSCA
sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding
that in the absence of sufficient information to permit a reasoned
evaluation, the substances may present an unreasonable risk of injury
to the environment. To protect against these risks, the Order requires:
<bullet> No processing for use or use of the PMN substances in a
consumer product unless the concentration of the PMN substances
combined does not exceed 1.7% by weight in the consumer product;
<bullet> No release of the PMN substances, or any waste stream
containing the PMN substances, resulting in surface water
concentrations that exceed 18 ppb; and
<bullet> Establishment of a hazard communication program, including
human health and environmental precautionary statements on each label
and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of aquatic
toxicity testing may be potentially useful to characterize the
environmental effects of the PMN 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-22-163 (40 CFR 721.12229)
Chemical Name: Multi-walled carbon nanotubes.
CASRN or Accession No.: Not available.
Effective Date of TSCA Order: July 7, 2025.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as an additive used in battery manufacture.
Based on comparison to analogous chemical substances, EPA has
identified concerns for lung and systemic effects, lung
carcinogenicity, genetic toxicity, and eye and respiratory irritation.
Due to insufficient information, EPA was unable to estimate the
environmental hazard of the PMN substance. The Order was issued under
TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a
finding that in the absence of sufficient information to permit a
reasoned evaluation, the substance may present an unreasonable risk of
injury to human health and the environment. To protect against these
risks, the Order requires:
<bullet> Use of personal protective equipment where there is a
potential for dermal exposure;
<bullet> Personal breathing zone (PBZ) exposure monitoring in
accordance with the procedures and conditions described in the Order;
<bullet> The order requires exposure monitoring. Before the
required exposure monitoring occurs where there is a potential for
inhalation exposure: (1) use of a NIOSH-certified respirator with an
APF of at least 50 is required at the confidential site listed in the
Order, (2) use of a NIOSH-certified respirator with an APF of 50 is
required at sites where batteries or the other confidential items
listed in the Order containing the PMN substance are only recycled. or
(3) use of a NIOSH-certified respirator with an APF of at least 1,000
is required at all other sites.
After the required exposure monitoring occurs: (1) compliance with
a NCEL of 8.97E-05 mg/m\3\ as an 8-hour time-weighted average, or use
of a NIOSH-certified respirator with an APF in accordance with Table 2
in the Order (which lists required respiratory protection/action
corresponding to different exposures) is required, (2) use of a NIOSH-
certified respirator with an APF of 50 is permitted at sites where
batteries or the other confidential items listed in the Order
containing the PMN substance are only recycled.
<bullet> Manufacture of the PMN substance only by import into the
United States (i.e., no domestic manufacture);
<bullet> Processing of the PMN substance only with the use of
engineering controls with an overall minimum efficiency of 94%;
<bullet> Processing for use and use of the PMN substance in the
final battery only if the concentration of the PMN substance does not
exceed the confidential concentration listed in the Order;
<bullet> Use of the PMN substance only as an additive used in
battery manufacture;
<bullet> No release of the PMN substance, or any waste stream
containing the PMN substance, to water; and
<bullet> Establishment of a hazard communication program, including
human health and environmental precautionary statements on each label
and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of
carcinogenicity, eye irritation, specific target organ toxicity,
pulmonary effects, and aquatic toxicity testing may be potentially
useful to characterize the health and environmental effects of the PMN
substance. Although the Order does not require these tests, the Order's
restrictions remain in effect until the Order is modified or revoked by
EPA based on submission of this or other relevant information.
P-22-187 and P-24-88 (40 CFR 721.12230)
Chemical Name: Mixed metal oxide (generic) (P-22-187 and P-24-88).
Accession No.: 303027.
Effective Date of TSCA Orders: November 30, 2023 (P-22-187) and
October 4, 2024 (P-24-88).
Basis for action: PMN P-22-187 states that the generic (non-
confidential) use will be as a substance for use in the manufacture of
battery components. Based on test data on the PMN substance, EPA
identified concerns for developmental effects. Based on comparison to
analogous respirable, poorly soluble particulates, EPA also identified
concerns for lung effects (including lung overload). EPA issued an
Order under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I),
based on a finding that in the absence of sufficient information to
permit a reasoned evaluation, the substance may present an unreasonable
risk of injury to human health. To protect against these risks, the
Order for PMN P-22-187 required:
<bullet> Use of a NIOSH-certified particulate respirator with an
APF of at least 1000 where there is a potential for inhalation
exposure;
<bullet> Manufacture of the PMN substance only by import into the
United States (i.e., no domestic manufacture) with <10% respirable
particles (i.e., particle size <=10 microns);
[[Page 34486]]
<bullet> Manufacture, processing, and use of the PMN substance only
when using dust controls with a capture and control efficiency of >97%
when the PMN substance is in solid form;
<bullet> Processing for use and use of the PMN substance only for
the confidential use listed in the Order;
<bullet> Disposal of the PMN substance and waste streams containing
the PMN substance only by landfill or using hazardous waste
incineration with >99.9% removal efficiency;
<bullet> Use of personal protective equipment where there is a
potential for dermal exposure; and
<bullet> Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
On July 31, 2025, the submitter of PMN P-22-187. requested a
modification of their Order to allow the use of a NIOSH-certified
particulate respirator with an APF of at 10 to replace the then
currently required respirator with an APF of 1000. EPA performed a risk
assessment based on the new intended conditions of use, subsequently
modified the terms of the Order to mitigate any unreasonable risks to
human health and the environment, and issued a modified Order,
effective September 17, 2025. To protect against these risks, the
modified Order requires:
<bullet> Use of a NIOSH-certified particulate respirator with an
APF of at least 10 where there is a potential for inhalation exposure;
<bullet> Manufacture of the PMN substance only by import into the
United States (i.e., no domestic manufacture) with <10% respirable
particles (i.e., particle size <=10 microns);
<bullet> Manufacture, processing, and use of the PMN substance only
when using dust controls with a capture and control efficiency of >97%
when the PMN substance is in solid form;
<bullet> Processing for use and use of the PMN substance only for
the confidential use listed in the Order;
<bullet> Disposal of the PMN substance and waste streams containing
the PMN substance only by landfill or using hazardous waste
incineration with >99.9% removal efficiency;
<bullet> Use of personal protective equipment where there is a
potential for dermal exposure; and
<bullet> Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
On February 26, 2024, EPA received a second PMN, P-24-88, for the
same substance due to the fact that PMN P-22-187 had not been commenced
and the substance had not been added to the TSCA Inventory. PMN P-24-88
states that the generic (non-confidential) use will be in the
manufacture of battery components. Based on comparison to analogous
respirable, poorly soluble particulates, EPA has identified concerns
for lung effects and lung cancer. The Order was issued under TSCA
sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding
that in the absence of sufficient information to permit a reasoned
evaluation, the substance may present an unreasonable risk of injury to
human health. To protect against these risks, the Order for PMN P-24-88
requires:
<bullet> Manufacture, processing, or use of the PMN substance in
solid form only when using dust controls with a capture and control
efficiency of at least >97%;
<bullet> Use of a NIOSH-certified respirator with an APF of at
least 10 where there is a potential for inhalation exposure;
<bullet> Use of personal protective equipment where there is a
potential for dermal exposure; and
<bullet> Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures including engineering controls.
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
carcinogenicity and pulmonary effects testing may be potentially useful
to characterize the health effects of the PMN(s) substance. Although
the Order does not require these tests, the Order's restrictions remain
in effect until the Order is modified or revoked by EPA based on
submission of this or other relevant information. The proposed SNUR
would designate as a ``significant new use'' the absence of these
protective measures.
P-23-96 (40 CFR 721.12231)
Chemical Name: Rosin, fumarated, polymer with adipic acid and
glycerol.
CASRN: 2888640-13-7.
Effective Date of TSCA Order: May 19, 2025.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as an additive for the packaging industry.
Based on comparison to analogous chemical substances, EPA has
identified concerns for skin sensitization and eye irritation. Based on
comparison to analogous esters, EPA predicts toxicity to aquatic
organisms may occur at concentrations that exceed 330 ppb. The Order
was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I),
based on a finding that in the absence of sufficient information to
permit a reasoned evaluation, the substance may present an unreasonable
risk of injury to human health and the environment. To protect against
these risks, the Order requires:
<bullet> Use of personal protective equipment where there is a
potential for dermal exposure;
<bullet> No processing for use or use of the PMN substance in a
consumer product;
<bullet> No release of the PMN substance, or any waste stream
containing the PMN substance, resulting in surface water concentrations
that exceed 330 ppb; and
<bullet> Establishment of a hazard communication program, including
human health and environmental precautionary statements on each label
and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of eye
irritation, skin irritation, and aquatic toxicity testing may be
potentially useful to characterize the health and environmental effects
of the PMN substance. Although the Order does not require these tests,
the Order's restrictions remain in effect until the Order is modified
or revoked by EPA based on submission of this or other relevant
information.
P-23-99 (40 CFR 721.12232)
Chemical Name: Derivatives of fats and oils, plant based,
polycyclic acids functionalized, aromatic acids, polyester with diols
and triols (generic).
CASRN or Accession No.: Not available.
Effective Date of TSCA Order: July 3, 2025.
Basis for TSCA Order: The PMN states that the use will be in
polyisocyanurate (PIR) and polyurethane (PUR) rigid insulation
materials. Based on comparison to analogous chemical substances, EPA
has identified concerns for skin, eye, and respiratory irritation, skin
sensitization, systemic effects, reproductive/developmental effects,
and portal-of-entry GI effects. Based on comparison to analogous
esters, EPA
[[Page 34487]]
predicts toxicity to aquatic organisms may occur at concentrations that
exceed 21 ppb. The Order was issued under TSCA sections
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the
absence of sufficient information to permit a reasoned evaluation, the
substance may present an unreasonable risk of injury to human health
and the environment. To protect against these risks, the Order
requires:
<bullet> Use of personal protective equipment where there is a
potential for dermal exposure;
<bullet> Use of a NIOSH-certified respirator with an APF of at
least 10 where there is a potential for inhalation exposure;
<bullet> No processing for use or use of the PMN substance in a
consumer product;
<bullet> No use of the PMN substance in spray applications;
<bullet> No release of the PMN substance, or any waste stream
containing the PMN substance, resulting in surface water concentrations
that exceed 21 ppb; and
<bullet> Establishment of a hazard communication program, including
human health and environmental precautionary statements on each label
and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of skin
irritation, eye irritation, specific target organ toxicity,
reproductive/developmental toxicity, skin sensitization, and aquatic
toxicity testing may be potentially useful to characterize the health
and environmental effects of the PMN substance. Although the Order does
not require these tests, the Order's restrictions remain in effect
until the Order is modified or revoked by EPA based on submission of
this or other relevant information.
P-23-105 (40 CFR 721.12233)
Chemical Name: Multi-walled carbon nanotubes.
CASRN or Accession No.: Not available.
Effective Date of TSCA Order: July 9, 2025.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as a plastic and rubber additive. Based on
comparison to analogous chemical substances, EPA has identified
concerns for lung and systemic effects, lung carcinogenicity, genetic
toxicity, eye and respiratory irritation, skin and respiratory
sensitization, carcinogenicity, reproductive, developmental,
neurotoxic, and systemic effects. Due to insufficient information, EPA
was unable to estimate the environmental hazard of the PMN substance.
The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and
5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient
information to permit a reasoned evaluation, the substance may present
an unreasonable risk of injury to human health and the environment. To
protect against these risks, the Order requires:
<bullet> Use of personal protective equipment where there is a
potential for dermal exposure;
<bullet> Use of a NIOSH-certified respirator with an APF of at
least 1000 where there is a potential for inhalation exposure;
<bullet> No domestic manufacture of the PMN substance (i.e., import
only);
<bullet> Manufacture, processing, and use of the PMN substance in
solid form only when using engineering controls with a minimum
efficiency of 95% capture and 99% control. Engineering controls are not
needed when the PMN substance is in liquid solution or dispersion;
<bullet> Manufacture, process, or use of the PMN substance only
when the confidential residual listed in the Order is present at the
confidential limit listed in the Order or less by weight;
<bullet> No processing for use or use of the PMN substance in a
consumer product;
<bullet> Use of the PMN substance only for the confidential use
listed in the Order;
<bullet> Manufacture of the PMN substance only below the
confidential annual production volume listed in the Order;
<bullet> No release of the PMN substance, or any waste stream
containing the PMN substance, to water; and
<bullet> Establishment of a hazard communication program, including
human health and environmental precautionary statements on each label
and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of
carcinogenicity, eye irritation, specific target organ toxicity,
pulmonary effects, and aquatic toxicity testing may be potentially
useful to characterize the health and environmental effects of the PMN
substance. Although the Order does not require these tests, the Order's
restrictions remain in effect until the Order is modified or revoked by
EPA based on submission of this or other relevant information.
P-23-156 (40 CFR 721.12234)
Chemical Name: Polysubstitutedcarbocycle, polyhydroxy, polyalkyl
(generic).
CASRN or Accession No.: Not available.
Effective Date of TSCA Order: May 28, 2025.
Basis for TSCA Order: The PMN states that the use will be as an
additive (e.g., detergent, cleaning agent, dispersant, chelating agent,
sequestering agent) used in laundry products (e.g., pods, liquids).
Based on submitted test data on the PMN substance, EPA has identified
concerns for skin sensitization and GI and systemic effects. Based on
OECD Toolbox, EPA has also identified concerns for respiratory
sensitization. Based on submitted test data on the PMN substance, EPA
predicts toxicity to aquatic organisms may occur at concentrations that
exceed 19 ppb. The Order was issued under TSCA sections
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the
absence of sufficient information to permit a reasoned evaluation, the
substance may present an unreasonable risk of injury to human health
and the environment. To protect against these risks, the Order
requires:
<bullet> Use of personal protective equipment where there is a
potential for dermal exposure;
<bullet> Use of a NIOSH-certified respirator with an APF of at
least 50, or 1000 if spray applied, where there is a potential for
inhalation exposure;
<bullet> Manufacture of the PMN substance only by import into the
United States (i.e., no domestic manufacture);
<bullet> No processing for use or use of the PMN substance in a
consumer product where the concentration of the PMN substance is equal
to or exceeds the confidential percentage in formulation listed in the
Order;
<bullet> No release of the PMN substance, or any waste stream
containing the PMN substance, resulting in surface water concentrations
that exceed 19 ppb; and
<bullet> Establishment of a hazard communication program, including
human health and environmental precautionary statements on each label
and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
[[Page 34488]]
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
workplace exposure monitoring may be potentially useful to characterize
the health effects of the PMN substance. Although the Order does not
require these tests, the Order's restrictions remain in effect until
the Order is modified or revoked by EPA based on submission of this or
other relevant information.
P-24-45 (40 CFR 721.12235)
Chemical Name: Cashew, nutshell liq., polymer with epichlorohydrin
and glycol (generic).
CASRN or Accession No.: Not available.
Effective Date of TSCA Order: June 23, 2025.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be for coatings and adhesives. Based on
structure of the PMN substance, EPA has identified concerns for lung
effects (surfactancy). Based on comparison to analogous chemical
substances of the LMW fraction, EPA has identified concerns for skin,
eye, and respiratory tract irritation, and systemic, developmental, and
reproductive effects. The Order was issued under TSCA sections
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the
absence of sufficient information to permit a reasoned evaluation, the
substance may present an unreasonable risk of injury to human health.
To protect against these risks, the Order requires:
<bullet> Use of personal protective equipment where there is a
potential for dermal exposure;
<bullet> Use of a NIOSH-certified respirator with an APF of at
least 50 where there is a potential for inhalation exposure;
<bullet> No processing for use or use of the PMN substance in a
consumer product;
<bullet> No spray application of the PMN substance; and
<bullet> Establishment of a hazard communication program, including
human health and environmental precautionary statements on each label
and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of eye
irritation, pulmonary effects, skin irritation, reproductive/
developmental toxicity, and specific target organ toxicity testing may
be potentially useful to characterize the health effects of the PMN
substance. Although the Order does not require these tests, the Order's
restrictions remain in effect until the Order is modified or revoked by
EPA based on submission of this or other relevant information.
P-24-54 (40 CFR 721.12236), P-24-55 (40 CFR 721.12237), and P-24-56 (40
CFR 721.12238)
Chemical Names: Fatty acids, reaction products with alkene
polyamine (generic) (P-24-54, P-24-55, and P-24-56).
CASRNs or Accession Nos.: Not available.
Effective Date of TSCA Order: July 31, 2025.
Basis for TSCA Order: The PMNs state that the generic (non-
confidential) uses will be as additives in paving applications. Based
on comparison to analogous chemical substances, EPA has identified
concerns for corrosion to the eyes, skin and respiratory tract, skin
sensitization, portal-of-entry (GI) and systemic effects, and
identified lung toxicity based on structure and intended use. Based on
comparison to analogous aliphatic amines, EPA predicts toxicity to
aquatic organisms may occur at concentrations that exceed 0.4 ppb (P-
24-54), 0.1 ppb (P-24-55), and 1 ppb (P-24-56). The Order was issued
under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a
finding that in the absence of sufficient information to permit a
reasoned evaluation, the substances may present an unreasonable risk of
injury to human health and the environment. To protect against these
risks, the Order requires:
<bullet> No manufacture, processing, or use of the PMN substances
in any manner that results in inhalation exposure to the PMN
substances;
<bullet> No processing for use or use of the PMN substances in a
consumer product;
<bullet> No use of the PMN substances other than as chemical
intermediates;
<bullet> No release of the PMN substances, or any waste stream
containing the PMN substances, to water;
<bullet> Use of personal protective equipment where there is a
potential for dermal exposure; and
<bullet> Establishment of a hazard communication program, including
human health and environmental precautionary statements on each label
and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of eye
irritation/corrosion, pulmonary effects, skin irritation/corrosion,
skin sensitization, specific target organ toxicity, and aquatic
toxicity testing may be potentially useful to characterize the health
and environmental effects of the PMN substances. Although the Order
does not require these tests, the Order's restrictions remain in effect
until the Order is modified or revoked by EPA based on submission of
this or other relevant information.
P-24-58 (40 CFR 721.12239) and P-24-59 (40 CFR 721.12240)
Chemical Names: Functionalized fatty acids, reaction products with
alkene polyamines (generic) (P-24-58 and P-24-59).
CASRNs or Accession Nos.: Not available.
Effective Date of TSCA Order: July 31, 2025.
Basis for TSCA Order: The PMNs state that the generic (non-
confidential) uses will be as additives in paving applications. Based
on dispersible water solubility, structure, and repeated amine
moieties, EPA has identified concerns for lung effects (surfactancy and
cationic binding). Based on pH and comparison to analogous chemical
substances, EPA has also identified concerns for skin corrosion and
serious eye damage. Based on comparison to analogous chemical
substances, EPA has also identified concerns for acute toxicity, skin
sensitization, portal-of-entry effects, and systemic effects. Based on
comparison to analogous polycationic polymers, EPA predicts toxicity to
aquatic organisms may occur at concentrations that exceed 0.7 ppb for
the P-24-58 substance. Based on comparison to analogous aliphatic
amines, EPA predicts toxicity to aquatic organisms may occur at
concentrations that exceed 3.5 ppb for the P-24-59 substance. The Order
was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I),
based on a finding that in the absence of sufficient information to
permit a reasoned evaluation, the substances may present an
unreasonable risk of injury to human health and the
[[Page 34489]]
environment. To protect against these risks, the Order requires:
<bullet> No manufacture, processing, or use of the PMN substances
in any manner that results in inhalation exposure to the PMN
substances;
<bullet> No processing for use or use of the PMN substances in a
consumer product;
<bullet> No use of the PMN substances other than as chemical
intermediates;
<bullet> No release of the PMN substances, or any waste stream
containing the PMN substances, to water;
<bullet> Use of personal protective equipment where there is a
potential for dermal exposure; and
<bullet> Establishment of a hazard communication program, including
human health and environmental precautionary statements on each label
and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of acute
toxicity, eye corrosion, pulmonary effects, skin corrosion, skin
sensitization, specific target organ toxicity, and aquatic toxicity
testing may be potentially useful to characterize the health and
environmental effects of the PMN substances. Although the Order does
not require these tests, the Order's restrictions remain in effect
until the Order is modified or revoked by EPA based on submission of
this or other relevant information.
P-24-98 (40 CFR 721.12241), P-25-60 (40 CFR 721.12242), and P-25-64 (40
CFR 721.12243)
Chemical Names: Substitutedheterocyclic onium compound, salt with
fluoropolysubstitutedalkyl substitutedtricycloalkane carboxylate (1:1),
polymer with 4-ethenyl-2-methoxylphenol and
fluorosubstitutedaromaticalkyl 2-methyl-2-propenoate, di-Me 2,2'-(1,2-
diazenediyl)bis[2- methylpropanoate]-initiated (generic) (P-24-98),
Dibenzothiophenium, 5-phenyl-, salt with fluoroheterosubstitutedalkyl
heterosubstitutedhalosubstitutedaromatichydrocarboncarboxylate (1:1),
polymer with 3- ethenylphenol and fluorocarbomonocyclealkyl 2-methyl-2-
propenoate (generic) (P-25-60), and Dibenzothiophenium, 5-phenyl-, salt
with fluoroheterosubstitutedalkyl
heterosubstitutedhalosubstitutedaromatichydrocarboncarboxylate (1:1),
polymer with 3- ethenylphenol and alkylcycloalkyl 2-methyl-2-propenoate
(generic) (P-25-64).
CASRNs or Accession Nos.: Not available.
Effective Date of TSCA Order: June 27, 2025.
Basis for TSCA Order: The PMNs state that the generic (non-
confidential) use of the PMN substances will be for contained uses for
microlithography for electronic device manufacture. Based on the
physical/chemical properties of the PMN substances (as described in the
New Chemical Program's PBT category at 64 FR 60194; November 1999) and
in the absence of data, the anion and cation of the P-24-98 substance,
the cations of the P-25-60 and P-25-64 substances, and the cation
photodegradation products of the P-24-98, P-25-60, and P-25-64
substances are potentially persistent, bioaccumulative, and toxic (PBT)
chemicals. EPA estimates that the anion and cation of the P-24-98
substance and the cations of the P-25-60 and P-25-64 substances will
persist in the environment for more than six months and that their
potential to bioaccumulate is unknown. EPA estimates that the cation
photodegradation products of the P-24-98, P-25-60, and P-25-64
substances will persist in the environment for more than six months and
estimates a bioaccumulation factor of greater than or equal to 5,000.
Based on comparison to analogous chemical substances, EPA has
identified concerns for acute toxicity, irritation to the skin and
respiratory tract, eye corrosion, and neurological and systemic effects
for the cations of the P-24-98, P-25-60, and P-25-64 substances. Based
on photoreactivity, EPA has also identified concerns for
photosensitization for the P-24-98, P-25-60, and P-25-64 substances.
Based on the point of departure value, EPA has also identified concerns
for local, neurological, developmental, and systemic effects for a
representative incineration product of the P-24-98 substance. Based on
comparison to analogous chemical substances, EPA has also identified
concerns for genetic toxicity for the P-24-98, P-25-60, and P-25-64
substances. Due to insufficient information, EPA was unable to estimate
the environmental hazard of the PMN substances. The Order was issued
under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a
finding that in the absence of sufficient information to permit a
reasoned evaluation, the substances may present an unreasonable risk of
injury to human health or the environment. To protect against these
risks, the Order requires:
<bullet> No manufacture of the PMN substances beyond the time
limits specified in the Order without submittal to EPA the results of
certain testing described in the Testing section of the Order;
<bullet> Use of personal protective equipment where there is a
potential for dermal exposure;
<bullet> Establishment of a hazard communication program, including
human health and environmental precautionary statements on each label
and in the SDS;
<bullet> No processing of the PMN substances in any way that
generates vapor, dust, mist, or aerosol in a non-enclosed process;
<bullet> Use of the PMN substances only for the confidential use
listed in the Order;
<bullet> No domestic manufacture of the PMN substances (i.e.,
import only);
<bullet> Import of the PMN substance only in solution unless in
sealed containers weighing 5 kilograms or less; and
<bullet> No exceedance of the confidential annual importation
volume listed the Order.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information about the physical/chemical properties, fate,
bioaccumulation, environmental hazard, and human health effects of the
PMN substances may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. The submitter has agreed not to exceed the
time limits specified in the Order without performing the required Tier
I and Tier II testing outlined in the Testing section of the Order.
P-24-109 (40 CFR 721.12244)
Chemical Name: Lithium dihalo (oxalato)borate(1-) (generic).
CASRN or Accession No.: Not available.
Effective Date of TSCA Order: August 11, 2025.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as an electrolyte salt. Based on comparison
to analogous chemical substances and submitted test data on the PMN
substance, EPA has identified concerns for acute toxicity, skin
irritation, eye corrosion, respiratory irritation, skin sensitization,
systemic and developmental effects, and
[[Page 34490]]
neurotoxicity. Based on comparison to analogous boron compounds and
submitted test data on the PMN substance, EPA predicts toxicity to
aquatic organisms may occur at concentrations that exceed 1 ppb. The
Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and
5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient
information to permit a reasoned evaluation, the substance may present
an unreasonable risk of injury to human health and the environment. To
protect against these risks, the Order requires:
<bullet> Use of personal protective equipment where there is a
potential for dermal exposure;
<bullet> No processing for use or use of the PMN substance in a
consumer product;
<bullet> No manufacture, processing, or use of the PMN substance in
any manner that results in inhalation exposure to the PMN substance;
<bullet> Manufacture, processing, and use of the PMN substance only
in a liquid solution;
<bullet> No release of the PMN substance, or any waste stream
containing the PMN substance, resulting in surface water concentrations
that exceed 1 ppb; and
<bullet> Establishment of a hazard communication program, including
human health and environmental precautionary statements on each label
and in the SDS.
EPA has concluded, based on information available to the Agency,
that use in the absence of several of these protective measures is
ongoing. Thus, use in the absence of those protective measures cannot
be designated as significant new uses. Therefore, EPA proposes to
designate as a significant new use:
<bullet> Use without a NIOSH-certified respirator with an APF of at
least 10 where there is a potential for inhalation exposure;
<bullet> Use of personal protective equipment where there is a
potential for dermal exposure;
<bullet> Use without establishment of a hazard communication
program, including human health and environmental precautionary
statements on each label and in the SDS.
<bullet> Use of the PMN substance in a consumer product; and
<bullet> Release of the PMN substance, or any waste stream
containing the PMN substance, resulting in surface water concentrations
that exceed 1 ppb.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of
specific target organ toxicity, reproductive toxicity, developmental
toxicity, neurotoxicity, and skin sensitization testing may be
potentially useful to characterize the health effects of the PMN
substance. Although the Order does not require these tests, the Order's
restrictions remain in effect until the Order is modified or revoked by
EPA based on submission of this or other relevant information.
P-24-112 (40 CFR 721.12245)
Chemical Name: Carbamodithioic acid, N,N-bis(phenylmethyl)-, compd.
with 2,2'-dithiobis[ethanamine] (2:1).
CASRN: 239446-62-9.
Effective Date of TSCA Order: August 6, 2025.
Basis for TSCA Order: The PMN states that the use will be as a
rubber accelerator for the manufacture of rubber articles. Based on
submitted test data on the PMN substance, EPA has identified concerns
for acute toxicity, skin sensitization, and systemic effects. Based on
test data on hydrolysis products, EPA has also identified concerns for
acute toxicity, systemic effects, neurotoxicity, and reproductive and
developmental effects. Based on comparison to analogous
dithiocarbamates and submitted test data on the PMN substance, EPA
predicts toxicity to aquatic organisms may occur at concentrations that
exceed 0.6 ppb. The Order was issued under TSCA sections
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the
absence of sufficient information to permit a reasoned evaluation, the
substance may present an unreasonable risk of injury to human health or
the environment. To protect against these risks, the Order requires:
<bullet> No processing for use or use of the PMN substance in a
consumer product;
<bullet> Use of a NIOSH-certified respirator with an APF of at
least 10 where there is a potential for inhalation exposure;
<bullet> Use of personal protective equipment where there is a
potential for dermal exposure;
<bullet> Manufacture of the PMN substance only by import in a
pellet form into the United States (i.e., no domestic manufacture);
<bullet> No release of the PMN substance, or any waste stream
containing the PMN substance, to water; and
<bullet> Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of acute
toxicity, skin sensitization, neurotoxicity, reproductive toxicity,
developmental toxicity, specific target organ toxicity, and aquatic
toxicity testing may be potentially useful to characterize the health
and environmental effects of the PMN substance. Although the Order does
not require these tests, the Order's restrictions remain in effect
until the Order is modified or revoked by EPA based on submission of
this or other relevant information.
P-24-146 (40 CFR 721.12246)
Chemical Name: Benzene, [alkyl [polycycloalkyl]-yl] polyfluoro-
alkyl- (generic).
CASRN or Accession No.: Not available.
Effective Date of TSCA Order: July 18, 2025.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as display materials. Based on comparison to
analogous chemical substances, EPA has identified concerns for systemic
effects. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and
5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient
information to permit a reasoned evaluation, the substance may present
an unreasonable risk of injury to human health. To protect against
these risks, the Order requires:
<bullet> Use of personal protective equipment where there is a
potential for dermal exposure;
<bullet> Manufacture, processing, and use of the PMN substance only
in a liquid solution;
<bullet> Use of the PMN substance only for the confidential use
listed in the Order;
<bullet> No release of the PMN substance, or any waste stream
containing the PMN substance, to water; and
<bullet> Establishment of a hazard communication program, including
human health and environmental precautionary statements on each label
and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information
[[Page 34491]]
may be potentially useful in support of a request by the PMN submitter
to modify the Order, or if a manufacturer or processor is considering
submitting a SNUN for a significant new use that will be designated by
this SNUR. EPA has determined that the results of specific target organ
toxicity and reproductive toxicity testing may be potentially useful to
characterize the health effects of the PMN substance. Although the
Order does not require these tests, the Order's restrictions remain in
effect until the Order is modified or revoked by EPA based on
submission of this or other relevant information.
P-24-148 (40 CFR 721.12247), P-24-149 (40 CFR 721.12248), P-24-150 (40
CFR 721.12249), and P-24-151 (40 CFR 721.12250)
Chemical Names: Substituted polyphenyl, alkyl-fluoro-alky (generic)
(P-24-148), Substituted polyphenyl, alkyl-polyfluoro-alkyl- (generic)
(P-24-149), Substituted polyphenyl, alkyl-alkyl-polyfluoro- (generic)
(P-24-150) and Substituted polyphenyl, alkyl-alkyl-fluoro- (generic)
(P-24-151).
CASRNs or Accession Nos.: Not available.
Effective Date of TSCA Order: July 18, 2025.
Basis for TSCA Order: The PMNs state that the generic (non-
confidential) uses will be as display materials. Based on the physical/
chemical properties of the PMN substances (as described in the New
Chemical Program's PBT category at 64 FR 60194; November 1999) and in
the absence of data, the PMN substances are potentially persistent,
bioaccumulative, and toxic (PBT) chemicals. EPA estimates that the PMN
substances will persist in the environment for more than six months and
estimates a bioaccumulation factor of greater than or equal to 5,000.
Based on test data for P-24-149 and physical/chemical properties of the
other substances, EPA has identified concerns for systemic and
reproductive effects. The Order was issued under TSCA sections
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the
absence of sufficient information to permit a reasoned evaluation, the
substances may present an unreasonable risk of injury to human health.
To protect against these risks, the Order requires:
<bullet> No manufacture, processing, or use of the PMN substances
in any manner that generates a vapor, mist, dust, or aerosol containing
the PMN substances;
<bullet> No processing for use or use of the PMN substances in a
consumer product;
<bullet> No use of the PMN substances other than for the
confidential use listed in the Order;
<bullet> When the PMN substances, or waste streams containing the
PMN substances, are disposed of by incineration, hazardous waste
incineration in compliance with RCRA subtitle C, incineration above
1,000 degrees C for at least two seconds must be used;
<bullet> No release of the PMN substances, or any waste stream
containing the PMN substances, to water;
<bullet> Use of personal protective equipment where there is a
potential for dermal exposure; and
<bullet> Establishment of a hazard communication program, including
human health and environmental precautionary statements on each label
and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of
reproductive toxicity and specific target organ toxicity testing may be
potentially useful to characterize the health effects of the PMN
substances. Although the Order does not require these tests, the
Order's restrictions remain in effect until the Order is modified or
revoked by EPA based on submission of this or other relevant
information.
P-24-152 (40 CFR 721.12251), P-24-153 (40 CFR 721.12252), and P-24-154
(40 CFR 721.12253)
Chemical Names: Phenyl carboxylic acid, alkylcycloalkyl,
phenylalkanediyl ester (generic) (P-24-152), Fluoro substituted
polyphenyl alkyl (generic) (P-24-153), and Polyphenyl, ethoxy-
polyfluoro-alkyl- (generic) (P-;24-154).
CASRNs or Accession Nos.: Not available.
Effective Date of TSCA Order: July 18, 2025.
Basis for TSCA Order: The PMNs state that the generic (non-
confidential) uses will be as display materials. Based on the physical/
chemical properties of the PMN substances (as described in the New
Chemical Program's PBT category at 64 FR 60194; November 1999) and in
the absence of data, the P-24-153 and P-24-154 PMN substances are
potentially persistent, bioaccumulative, and toxic (PBT) chemicals. EPA
estimates that the P-24-153 and P-24-154 PMN substances will persist in
the environment for more than six months and estimates a
bioaccumulation factor of greater than or equal to 5,000. Based on
comparison to analogous chemical substances, EPA has identified
concerns for systemic effects for P-24-152, P-24-153, and P-24-154.
Based on comparison to analogous chemical substances, EPA has also
identified concerns for reproductive effects for P-24-153. Based on
submitted test data on the P-24-154 PMN substance and comparison to
analogous neutral organics, EPA predicts toxicity to aquatic organisms
may occur at concentrations that exceed 0.5 ppb for P-24-154. The Order
was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I),
based on a finding that in the absence of sufficient information to
permit a reasoned evaluation, the substances may present an
unreasonable risk of injury to human health and the environment. To
protect against these risks, the Order requires:
<bullet> No manufacture, processing, or use of the PMN substances
in any manner that generates a vapor, mist, dust, or aerosol containing
the PMN substances;
<bullet> No processing for use or use of the PMN substances in a
consumer product;
<bullet> No use of the PMN substances other than for the
confidential use listed in the Order;
<bullet> Disposal of the PMN substances by hazardous waste landfill
only at a facility that is in compliance with Resource Conservation and
Recovery Act (RCRA) Subtitle C;
<bullet> Disposal of the P-24-153 and P-24-154 PMN substances, or
waste streams containing the P-24-153 and P-24-154 PMN substances, by
incineration only when hazardous waste incineration in compliance with
RCRA Subtitle C, incineration above 1,000 degrees C for at least two
seconds is used;
<bullet> No release of the PMN substances, or any waste stream
containing the PMN substances, to water;
<bullet> Use of personal protective equipment where there is a
potential for dermal exposure; and
<bullet> Establishment of a hazard communication program, including
human health and environmental precautionary statements on each label
and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will
[[Page 34492]]
be designated by this SNUR. EPA has determined that the results of
toxicokinetics and specific target organ toxicity testing on the P-24-
152 PMN substance, bioaccumulation, reproductive toxicity, specific
target organ toxicity, and aquatic toxicity testing on the P-24-153 PMN
substance, and bioaccumulation and chronic aquatic toxicity testing on
the P-24-154 PMN substance may be potentially useful to characterize
the fate, health, and environmental effects of the PMN substances.
Although the Order does not require these tests, the Order's
restrictions remain in effect until the Order is modified or revoked by
EPA based on submission of this or other relevant information.
P-24-163 (40 CFR 721.12254)
Chemical Name: Transition metal polykis (heteroatom substituted
carbomonocycle), hydroxy- oxo- (generic).
CASRN or Accession No.: Not available.
Effective Date of TSCA Order: August 5, 2025.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be in gas adsorption cartridges and protective
garments. Based on structure and physical/chemical properties of the
PMN substance, EPA has identified concerns for lung effects (lung
overload). The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I)
and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of
sufficient information to permit a reasoned evaluation, the substance
may present an unreasonable risk of injury to human health. To protect
against these risks, the Order requires:
<bullet> Use of personal protective equipment where there is a
potential for dermal exposure;
<bullet> Use of a NIOSH-certified respirator with an APF of at
least 1000 when the proportion of the PMN substance with a particle
size less than 10 microns is >0.1% by weight where there is a potential
for inhalation exposure. When the proportion of the PMN substance with
a particle size less than 10 microns is <=0.1% (by weight), there are
no inhalation risks, and therefore the worker respirator requirement
does not apply;
<bullet> Use of the PMN substance only for the confidential use
listed in the Order; and
<bullet> Establishment of a hazard communication program, including
human health and environmental precautionary statements on each label
and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of
pulmonary effects testing may be potentially useful to characterize the
health effects of the PMN substance. Although the Order does not
require these tests, the Order's restrictions remain in effect until
the Order is modified or revoked by EPA based on submission of this or
other relevant information.
P-25-58 (40 CFR 721.12255)
Chemical Name: Heteromonocyclealkanol, homopolymer, monoalkyl ether
(generic).
CASRN or Accession No.: Not available.
Effective Date of TSCA Order: August 29, 2025.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as a component of a cleaner. Based on
structure, EPA has identified concerns for pulmonary effects. Based on
comparison to analogous chemical substances, EPA has also identified
concerns for skin irritation and systemic effects. Based on comparison
to analogous nonionic surfactants, EPA predicts toxicity to aquatic
organisms may occur at concentrations that exceed 140 ppb. The Order
was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I),
based on a finding that in the absence of sufficient information to
permit a reasoned evaluation, the substance may present an unreasonable
risk of injury to human health and the environment. To protect against
these risks, the Order requires:
<bullet> Use of personal protective equipment where there is a
potential for dermal exposure;
<bullet> Manufacture, processing, and use of the PMN substance only
in a manner that does not result in inhalation exposure to the PMN
substance;
<bullet> Processing for use and use of the PMN substance only for
the confidential use listed in the Order;
<bullet> No disposal of the PMN substance, or any waste stream
containing the PMN substance, other than by incineration, deep well
injection, or landfill. Disposal of the PMN substance, or waste steams
containing the PMN substance, by landfill must use a hazardous waste
landfill facility that is in compliance with RCRA subtitle C and D;
<bullet> No release of the PMN substance, or any waste stream
containing the PMN substance, resulting in surface water concentrations
that exceed 140 ppb; and
<bullet> Establishment of a hazard communication program, including
human health and environmental precautionary statements on each label
and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of skin
irritation, pulmonary effects, specific target organ toxicity, and
aquatic toxicity testing may be potentially useful to characterize the
health and environmental effects of the PMN substance. Although the
Order does not require these tests, the Order's restrictions remain in
effect until the Order is modified or revoked by EPA based on
submission of this or other relevant information.
P-25-66 (40 CFR 721.12256)
Chemical Name: Sulfonium, bis(dihalo
carbomonocycle)carbomonocycle-. salt with dihalo-sulfoalkyl
[(alkenylcarbomonocycle)substituted] trisubstituted benzoate, polymer
with alkenylcarbomonocycle and alkylcarbomonocycle alkyl alkenoate
(generic).
CASRN or Accession No.: 303323.
Effective Date of TSCA Order: June 23, 2025.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use of the PMN substance will be as an ingredient used in
the manufacture of photoresist. Based on the physical/chemical
properties of the PMN substance (as described in the New Chemical
Program's PBT category at 64 FR 60194; November 1999) and in the
absence of data, the cation of the PMN substance and the cation
photodegradation product are potentially persistent, bioaccumulative,
and toxic (PBT) chemicals. EPA estimates that the cation of the PMN
substance will persist in the environment for more than six months and
that its potential to bioaccumulate is unknown. EPA estimates that the
cation photodegradation product will persist in the environment for
more than
[[Page 34493]]
six months and estimates a bioaccumulation factor of greater than or
equal to 5,000. Based on analogy to sulfonium compounds, EPA has
identified concerns for acute toxicity, irritation to the skin, eyes,
and respiratory tract, eye corrosion, neurological, and systemic
effects for the sulfonium cation. Based on photoreactivity, EPA has
also identified concerns for photosensitization. Based on comparison to
analogous chemical substances, EPA has also identified concerns for
genetic toxicity. Due to insufficient information, EPA was unable to
estimate the environmental hazard of the PMN substance. The Order was
issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I),
based on a finding that in the absence of sufficient information to
permit a reasoned evaluation, the substance may present an unreasonable
risk of injury to human health or the environment. To protect against
these risks, the Order requires:
<bullet> No manufacture of the PMN substance beyond the time limits
specified in the Order without submittal to EPA the results of certain
testing described in the Testing section of the Order;
<bullet> Use of personal protective equipment where there is a
potential for dermal exposure;
<bullet> Establishment of a hazard communication program, including
human health and environmental precautionary statements on each label
and in the SDS;
<bullet> No processing of the PMN substance in any way that
generates vapor, dust, mist, or aerosol in a non-enclosed process;
<bullet> Use of the PMN substance only for the confidential use
listed in the Order;
<bullet> No domestic manufacture of the PMN substance (i.e., import
only);
<bullet> Import of the PMN substance only in solution unless in
sealed containers weighing 5 kilograms or less; and
<bullet> No exceedance of the confidential annual importation
volume listed the Order.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information about the physical/chemical properties, fate,
bioaccumulation, environmental hazard, and human health effects of the
PMN substance may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. The submitter has agreed not to exceed the
time limits specified in the Order without performing the required Tier
I and Tier II testing outlined in the Testing section of the Order.
P-25-70 (40 CFR 721.12257)
Chemical Name: Sulfonium, bis(dihalo carbomonocycle)(halo
carbomonocycle)-, salt with dihalo-sulfoalkyl
[(alkenylcarbomonocycle)substituted] trisubstituted benzoate, polymer
with alkenylcarbomonocycle and alkylcarbomonocycle alkyl alkenoate
(generic).
CASRN or Accession No.: Not available.
Effective Date of TSCA Order: July 25, 2025.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use of the PMN substance will be as an ingredient used in
the manufacture of photoresist. Based on the physical/chemical
properties of the PMN substance (as described in the New Chemical
Program's PBT category at 64 FR 60194; November 1999) and in the
absence of data, the cation of the PMN substance and the cation
photodegradation product are potentially persistent, bioaccumulative,
and toxic (PBT) chemicals. EPA estimates that the cation of the PMN
substance will persist in the environment for more than six months and
that its potential to bioaccumulate is unknown. EPA estimates that the
cation photodegradation product will persist in the environment for
more than six months and estimates a bioaccumulation factor of greater
than or equal to 5,000. Based on comparison to analogous chemical
substances, EPA has identified concerns for acute toxicity, irritation
to the skin and respiratory tract, eye corrosion, genetic toxicity, and
neurological and systemic effects for the sulfonium cation. Based on
photoreactivity, EPA has also identified concerns for
photosensitization. Due to insufficient information, EPA was unable to
estimate the environmental hazard of the PMN substance. The Order was
issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I),
based on a finding that in the absence of sufficient information to
permit a reasoned evaluation, the substance may present an unreasonable
risk of injury to human health or the environment. To protect against
these risks, the Order requires:
<bullet> No manufacture of the PMN substance beyond the time limits
specified in the Order without submittal to EPA the results of certain
testing described in the Testing section of the Order;
<bullet> Use of personal protective equipment where there is a
potential for dermal exposure;
<bullet> Establishment of a hazard communication program, including
human health and environmental precautionary statements on each label
and in the SDS;
<bullet> No processing of the PMN substance in any way that
generates vapor, dust, mist, or aerosol in a non-enclosed process;
<bullet> Use of the PMN substance only for the confidential use
listed in the Order;
<bullet> No domestic manufacture of the PMN substance (i.e., import
only);
<bullet> Import of the PMN substance only in solution unless in
sealed containers weighing 5 kilograms or less; and
<bullet> No exceedance of the confidential annual importation
volume listed the Order.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information about the physical/chemical properties, fate,
bioaccumulation, environmental hazard, and human health effects of the
PMN substance may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. The submitter has agreed not to exceed the
time limits specified in the Order without performing the required Tier
I and Tier II testing outlined in the Testing section of the Order.
P-25-71 (40 CFR 721.12258)
Chemical Name: Sulfonium, bis(dihalo
carbomonocycle)(halocarbomonocycle)-, salt with trihalobenzoate
(generic).
CASRN or Accession No.: Not available.
Effective Date of TSCA Order: July 28, 2025.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use of the PMN substance will be as an ingredient used in
the manufacture of photoresist. Based on the physical/chemical
properties of the PMN substance (as described in the New Chemical
Program's PBT category at 64 FR 60194; November 1999) and in the
absence of data, the anion and cation of the PMN substance and the
cation photodegradation product are potentially persistent,
bioaccumulative, and toxic (PBT) chemicals. EPA estimates that the
anion and cation of
[[Page 34494]]
the PMN substance will persist in the environment for more than six
months and that their potential to bioaccumulate is unknown. EPA
estimates that the cation photodegradation product will persist in the
environment for more than six months and estimates a bioaccumulation
factor of greater than or equal to 5,000. Based on comparison to
analogous chemical substances, EPA has identified concerns for acute
toxicity, irritation to the skin and respiratory tract, eye corrosion,
genetic toxicity, and neurological and systemic effects for the
sulfonium cation. Based on photoreactivity, EPA has also identified
concerns for photosensitization. Based on OECD QSAR Toolbox alert, EPA
has also identified concerns for skin sensitization for the anion. Due
to insufficient information, EPA was unable to estimate the
environmental hazard of the PMN substance. The Order was issued under
TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a
finding that in the absence of sufficient information to permit a
reasoned evaluation, the substance may present an unreasonable risk of
injury to human health or the environment. To protect against these
risks, the Order requires:
<bullet> No manufacture of the PMN substance beyond the time limits
specified in the Order without submittal to EPA the results of certain
testing described in the Testing section of the Order;
<bullet> Use of personal protective equipment where there is a
potential for dermal exposure;
<bullet> Establishment of a hazard communication program, including
human health and environmental precautionary statements on each label
and in the SDS;
<bullet> No processing of the PMN substance in any way that
generates vapor, dust, mist, or aerosol in a non-enclosed process;
<bullet> Use of the PMN substance only for the confidential use
listed in the Order;
<bullet> No domestic manufacture of the PMN substance (i.e., import
only);
<bullet> Import of the PMN substance only in solution unless in
sealed containers weighing 5 kilograms or less; and
<bullet> No exceedance of the confidential annual importation
volume listed the Order.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information about the physical/chemical properties, fate,
bioaccumulation, environmental hazard, and human health effects of the
PMN substance may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. The submitter has agreed not to exceed the
time limits specified in the Order without performing the required Tier
I and Tier II testing outlined in the Testing section of the Order.
P-25-97 (40 CFR 721.12259)
Chemical Name: Aromatic sulfonium tricyclo salt with
carbopolycycloalkyl ester polysubstitutedarylhetero-acid (generic).
CASRN or Accession No.: 30367.
Effective Date of TSCA Order: August 20, 2025.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use of the PMN substance will be for photoacid generator
use at customer sites. Based on the physical/chemical properties of the
PMN substance (as described in the New Chemical Program's PBT category
at 64 FR 60194; November 1999) and in the absence of data, the anion of
the PMN substance and the cation photodegradation product are
potentially persistent, bioaccumulative, and toxic (PBT) chemicals. EPA
estimates that the anion of the PMN substance will persist in the
environment for more than six months and that its potential to
bioaccumulate is unknown. EPA estimates that the cation
photodegradation product will persist in the environment for more than
six months and estimates a bioaccumulation factor of greater than or
equal to 5,000. Based on comparison to analogous chemical substances,
EPA has identified concerns for acute toxicity, irritation to the skin
and respiratory tract, eye corrosion, genetic toxicity, and
neurological and systemic effects for the sulfonium cation. Based on
photoreactivity, EPA has also identified concerns for
photosensitization. Due to insufficient information, EPA was unable to
assess the human health hazard of the anion of the PMN substance. Due
to insufficient information, EPA was unable to estimate the
environmental hazard of the PMN substance. The Order was issued under
TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a
finding that in the absence of sufficient information to permit a
reasoned evaluation, the substance may present an unreasonable risk of
injury to human health or the environment. To protect against these
risks, the Order requires:
<bullet> No manufacture of the PMN substance beyond the time limits
specified in the Order without submittal to EPA the results of certain
testing described in the Testing section of the Order;
<bullet> Use of personal protective equipment where there is a
potential for dermal exposure;
<bullet> Establishment of a hazard communication program, including
human health and environmental precautionary statements on each label
and in the SDS;
<bullet> No processing of the PMN substance in any way that
generates vapor, dust, mist, or aerosol in a non-enclosed process;
<bullet> Use of the PMN substance only for the confidential use
listed in the Order;
<bullet> No domestic manufacture of the PMN substance (i.e., import
only);
<bullet> Import of the PMN substance only in solution unless in
sealed containers weighing 5 kilograms or less; and
<bullet> No exceedance of the confidential annual importation
volume listed the Order.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information about the physical/chemical properties, fate,
bioaccumulation, environmental hazard, and human health effects of the
PMN substance may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. The submitter has agreed not to exceed the
time limits specified in the Order without performing the required Tier
I and Tier II testing outlined in the Testing section of the Order.
IV. Statutory and Executive Order Reviews
Additional information about these statutes and Executive orders
can be found at <a href="https://www.epa.gov/laws-regulations">https://www.epa.gov/laws-regulations</a>.
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).
[[Page 34495]]
B. Executive Order 14192: Unleashing Prosperity Through Deregulation
Executive Order 14192 (90 FR 9065, February 6, 2025) does not apply
because a significant new use rule for a new chemical under TSCA
section 5 is 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). This action does not impose any burden
requiring additional OMB approval. If an entity were to submit a SNUN
to the Agency, the annual burden is estimated to average between 30 and
170 hours per submission. This burden estimate includes the time needed
to review instructions, search existing data sources, gather and
maintain the data needed, and complete, review, and submit the required
SNUN.
EPA always welcomes your feedback on the burden estimates. When
submitting comments on these proposed SNURs, include comments about the
accuracy of the burden estimate, and any suggested methods for
improving the collection instruments or instruction or minimizing
respondent burden, including through the use of automated collection
techniques.
D. Regulatory Flexibility Act (RFA)
I certify that this action will not have a significant economic
impact on a substantial number of small entities under the RFA (5
U.S.C. 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 2021 Policy on Children's Health also does not apply. Although
the establishment of these SNURs do not address an existing children's
environmental health concern because the chemical uses involved are not
ongoing uses, SNURs require that persons notify EPA at least 90 days
before commencing manufacture (defined by statute to include import) or
processing of the identified chemical substances for an activity that
is designated as a significant new use by the SNUR. This notification
allows EPA to assess the intended uses to identify potential risks and
take appropriate actions before the activities commence.
I. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use
This action is not a ``significant energy action'' as defined in
Executive Order 13211 (66 FR 28355, May 22, 2001), because it is not
likely to have a significant adverse effect on the supply,
distribution, or use of energy.
J. National Technology Transfer and Advancement Act (NTTAA)
This action does not involve any technical standards subject to
NTTAA section 12(d) (15 U.S.C. 272 note).
[[Page 34496]]
List of Subjects in 40 CFR Part 721
Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.
Dated: June 1, 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. 721.12225 through 721.12259 to subpart E to read as
follows:
* * * * *
Sec.
721.12225 Alcohols, C16-18 and C18-unsatd., reaction products with
substituted alkyloxirane.
721.12226 Manganate(4-), hexakis(cyano-.kappa.C)-, manganese(2+)
sodium, (OC-6-11)-.
721.12227 Ferrate(4-), hexakis(cyano-.kappa.C)-, iron(3+)
manganese(2+) sodium, (OC-6-11)-.
721.12228 1H,4H,14H,17H-2,16:3,15-Dimethano-
5H,6H,7H,8H,9H,10H,11H,12H,13H,18H,19H,20H,21H,22H,23H,24H,25H,26H-
2,3,4a,5a,6a,7a,8a,9a,10a,11a,12a,13a,15,16,17a,18a,19a,20a,21a,22a,2
3a,24a,25a,26a-
tetracosaazabispentaleno[1''',6''':5'',6'',7'']cycloocta[1'',2'',3'':
3',4']pentaleno[1',6':5,6,7]cycloocta[1,2,3-gh:1',2',3'-
g'h']cycloocta[1,2,3-cd:5,6,7-c'd']dipentalene-
1,4,6,8,10,12,14,17,19,21,23,25-dodecone, dodecahydro-,
stereoisomer; 2,18:3,17-Dimethano-
2,3,4a,5a,6a,7a,8a,9a,10a,11a,12a,13a,14a,15a,17,18,19a,20a,21a,22a,2
3a,24a,25a,26a,27a,28a,29a,30a-
octacosaazabispentaleno[1''''',6''''':5'''',
6'''',7'''']cycloocta[1'''',2'''',3'''':3''',4''']pentaleno[1''',6'''
:5'',6'',7'']cycloocta[1'',2'',3'':3',4']pentaleno[1',6':5,6,7]cycloo
cta[1,2,3-cd:1',2',3'-gh]pentalene-
1,4,6,8,10,12,14,16,19,21,23,25,27,29-tetradecone, tetradecahydro-,
stereoisomer; 2,20:3,19-Dimethano-
2,3,4a,5a,6a,7a,8a,9a,10a,11a,12a,13a,14a,15a,16a,17a,19,20,21a,22a,2
3a,24a,25a,26a,27a,28a,29a,30a,31a,32a,33a,34a-
dotriacontaazabispentaleno[1''''',6''''':5'''',6'''',7'''']cycloocta[
1'''',2'''',3'''':3''',4''']pentaleno[1''',6''':5'',6'',7'']cycloocta
[1'',2'',3'':3',4']pentaleno[1',6':5,6,7]cycloocta[1,2,3-
gh:1',2',3'-g'h']cycloocta[1,2,3-cd:5,6,7-c'd']dipentalene-
1,4,6,8,10,12,14,16,18,21,23,25,27,29,31,33-hexadecone,
hexadecahydro-, stereoisomer).
721.12229 Multi-walled carbon nanotubes.
721.12230 Mixed metal oxide (generic).
721.12231 Rosin, fumarated, polymer with adipic acid and glycerol.
721.12232 Derivatives of fats and oils, plant based, polycyclic
acids functionalized, aromatic acids, polyester with diols and
triols (generic).
721.12233 Multi-walled carbon nanotubes.
721.12234 Polysubstitutedcarbocycle, polyhydroxy, polyalkyl
(generic).
721.12235 Cashew, nutshell liq., polymer with epichlorohydrin and
glycol (generic).
721.12236 Fatty acids, reaction products with alkene polyamine
(generic).
721.12237 Fatty acids, reaction products with alkene polyamine
(generic).
721.12238 Fatty acids, reaction products with alkene polyamine
(generic).
721.12239 Functionalized fatty acids, reaction products with alkene
polyamines (generic).
721.12240 Functionalized fatty acids, reaction products with alkene
polyamines (generic).
721.12241 Substitutedheterocyclic onium compound, salt with
fluoropolysubstitutedalkyl substitutedtricycloalkane carboxylate
(1:1), polymer with 4-ethenyl-2-methoxylphenol and
fluorosubstitutedaromaticalkyl 2-methyl-2-propenoate, di-Me 2,2'-
(1,2-diazenediyl)bis[2- methylpropanoate]-initiated (generic).
721.12242 Dibenzothiophenium, 5-phenyl-, salt with
fluoroheterosubstitutedalkyl
heterosubstitutedhalosubstitutedaromatichydrocarboncarboxylate
(1:1), polymer with 3- ethenylphenol and fluorocarbomonocyclealkyl
2-methyl-2-propenoate (generic).
721.12243 Dibenzothiophenium, 5-phenyl-, salt with
fluoroheterosubstitutedalkyl
heterosubstitutedhalosubstitutedaromatichydrocarboncarboxylate
(1:1), polymer with 3- ethenylphenol and alkylcycloalkyl 2-methyl-2-
propenoate (generic).
721.12244 Lithium dihalo (oxalato)borate(1-) (generic).
721.12245 Carbamodithioic acid, N,N-bis(phenylmethyl)-, compd. with
2,2'-dithiobis[ethanamine] (2:1).
721.12246 Benzene, [alkyl [polycycloalkyl]-yl] polyfluoro-alkyl-
(generic).
721.12247 Substituted polyphenyl, alkyl-fluoro-alky (generic).
721.12248 Substituted polyphenyl, alkyl-polyfluoro-alkyl- (generic).
721.12249 Substituted polyphenyl, alkyl-alkyl-polyfluoro- (generic).
721.12250 Substituted polyphenyl, alkyl-alkyl-fluoro- (generic).
721.12251 Phenyl carboxylic acid, alkylcycloalkyl, phenylalkanediyl
ester (generic).
721.12252 Fluoro substituted polyphenyl alkyl (generic).
721.12253 Polyphenyl, ethoxy-polyfluoro-alkyl- (generic).
721.12254 Transition metal polykis (heteroatom substituted
carbomonocycle), hydroxy- oxo- (generic).
721.12255 Heteromonocyclealkanol, homopolymer, monoalkyl ether
(generic).
721.12256 Sulfonium, bis(dihalo carbomonocycle)carbomonocycle-. salt
with dihalo-sulfoalkyl [(alkenylcarbomonocycle)substituted]
trisubstituted benzoate, polymer with alkenylcarbomonocycle and
alkylcarbomonocycle alkyl alkenoate (generic).
721.12257 Sulfonium, bis(dihalo carbomonocycle)(halo
carbomonocycle)-, salt with dihalo-sulfoalkyl
[(alkenylcarbomonocycle)substituted] trisubstituted benzoate,
polymer with alkenylcarbomonocycle and alkylcarbomonocycle alkyl
alkenoate (generic).
721.12258 Sulfonium, bis(dihalo carbomonocycle)(halocarbomonocycle)-
, salt with trihalobenzoate (generic).
721.12259 Aromatic sulfonium tricyclo salt with carbopolycycloalkyl
ester polysubstitutedarylhetero-acid (generic).
* * * * *
Sec. 721.12225 Alcohols, C16-18 and C18-unsatd., reaction products
with substituted alkyloxirane and alkyl acid (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
alcohols, C16-18 and C18-unsatd., reaction products with substituted
alkyloxirane and alkyl acid (PMN P-21-76) is subject to reporting under
this section for the significant new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), and (3), and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1) and (5). For purposes of Sec.
721.72(g)(1), this substance may cause: skin sensitization and specific
target organ toxicity. Alternative hazard and warning statements that
meet the criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o). It is a significant new use to
manufacture, process, or use the substance in any manner that results
in inhalation exposure.
[[Page 34497]]
(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 (i) 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. 721.12226 Manganate(4-), hexakis(cyano-.kappa.C)-, manganese(2+)
sodium, (OC-6-11)-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as manganate(4-),
hexakis(cyano-.kappa.C)-, manganese(2+) sodium, (OC-6-11)- (PMN P-22-
40; CAS No. 2073840-04-5) is subject to reporting under this section
for the significant new uses described in paragraph (a)(2) of this
section. The requirements of this section do not apply to quantities of
the substance after they have been incorporated into an article.
(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 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 1000.
(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: acute
toxicity, skin sensitization, reproductive toxicity, and specific
target organ toxicity. Alternative hazard and warning statements that
meet the criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(b) and (c). For purposes of Sec.
721.80(b) and (c), the process remains enclosed as long as the only
releases are from sampling, dust filter changes, loss of integrity or
failure of the manufacturing process equipment or control systems. It
is a significant new use to use the substance other than as a component
in manufacture of high-performance batteries. It is a significant new
use to use the substance in any manner that results in inhalation
exposure to workers. It is a significant new use to perform the dust
filter change more than two times a year. It is a significant new use
to manufacture the substance at a site that has off-gas waste streams
unless all such waste streams are captured and routed through
engineering controls that achieve a total combined efficiency of 99.9%
destruction of the substance. It is a significant new use to
manufacture the substance unless the concentration of manganese does
not exceed the confidential percentage by weight listed in the Order.
(iv) Disposal. It is a significant new use to dispose of the
substance, when not in solid form, by landfill. The substance may be
disposed of by landfill at hazardous waste landfill facilities that are
in compliance with RCRA subtitle C and D, when in solid form. The
substance or waste streams containing the substance must be disposed of
by incineration, when not in solid form. It is a significant new use to
exceed the confidential disposal by incineration limit listed in the
Order. This limit does not apply to quantities sent for incineration at
a hazardous waste incineration facility that is compliant with RCRA
subtitle C.
(v) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=0.2.
(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. 721.12227 Ferrate(4-), hexakis(cyano-.kappa.C)-, iron(3+)
manganese(2+) sodium, (OC-6-11)-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as ferrate(4-),
hexakis(cyano-.kappa.C)-, iron(3+) manganese(2+) sodium, (OC-6-11)-
(PMN P-22-41; CAS No. 2073839-30-0) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section. The requirements of this section do not apply to
quantities of the substance after they have been incorporated into an
article.
(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 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 10.
(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: acute
toxicity, skin sensitization, reproductive toxicity, and specific
target organ toxicity. Alternative hazard and warning statements that
meet the criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(b) and (c). For purposes of Sec.
721.80(b) and (c), the process remains enclosed as long as the only
releases are from sampling, dust filter changes, loss of integrity or
failure of the manufacturing process equipment or control systems. It
is a significant new use to use the substance other than as a component
in manufacture of high-performance batteries. It is a significant new
use to use the substance in any manner that results in inhalation
exposure to workers. It is a significant new use to perform the dust
filter change more than two times a year. It is a significant new use
to manufacture the substance at a site that has off-gas waste streams
unless all such waste streams are captured and routed through
engineering controls that achieve a total combined efficiency of 99.9%
destruction of the substance. It is a significant new use to
manufacture the substance unless the concentration of manganese does
not exceed the confidential percentage by weight listed in the Order.
(iv) Disposal. It is a significant new use to dispose of the
substance, when not in solid form, by landfill. The substance may be
disposed of by landfill at hazardous waste landfill at a facility that
is in compliance with RCRA subtitle C and D, when in solid form.
[[Page 34498]]
The substance or waste streams containing the substance must be
disposed of by incineration, when not in solid form. It is a
significant new use to exceed the confidential disposal by incineration
limit listed in the Order. This limit does not apply to quantities sent
for incineration at a hazardous waste incineration facility that is
compliant with RCRA subtitle C.
(v) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=2.0.
(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. 721.12228 1H,4H,14H,17H-2,16:3,15-Dimethano-
5H,6H,7H,8H,9H,10H,11H,12H,13H,18H,19H,20H,21H,22H,23H,24H,25H,26H-
2,3,4a,5a,6a,7a,8a,9a,10a,11a,12a,13a,15,16,17a,18a,19a,20a,21a,22a,23a,
24a,25a,26a-
tetracosaazabispentaleno[1''',6''':5'',6'',7'']cycloocta[1'',2'',3'':3',
4']pentaleno[1',6':5,6,7]cycloocta[1,2,3-gh:1',2',3'-
g'h']cycloocta[1,2,3-cd:5,6,7-c'd']dipentalene-
1,4,6,8,10,12,14,17,19,21,23,25-dodecone, dodecahydro-, stereoisomer;
2,18:3,17-Dimethano-
2,3,4a,5a,6a,7a,8a,9a,10a,11a,12a,13a,14a,15a,17,18,19a,20a,21a,22a,23a,
24a,25a,26a,27a,28a,29a,30a-
octacosaazabispentaleno[1''''',6''''':5'''',
6'''',7'''']cycloocta[1'''',2'''',3'''':3''',4''']pentaleno[1''',6''':5'
',6'',7'']cycloocta[1'',2'',3'':3',4']pentaleno[1',6':5,6,7]cycloocta[1,
2,3-cd:1',2',3'-gh]pentalene-1,4,6,8,10,12,14,16,19,21,23,25,27,29-
tetradecone, tetradecahydro-, stereoisomer; 2,20:3,19-Dimethano-
2,3,4a,5a,6a,7a,8a,9a,10a,11a,12a,13a,14a,15a,16a,17a,19,20,21a,22a,23a,
24a,25a,26a,27a,28a,29a,30a,31a,32a,33a,34a-
dotriacontaazabispentaleno[1''''',6''''':5'''',6'''',7'''']cycloocta[1''
'',2'''',3'''':3''',4''']pentaleno[1''',6''':5'',6'',7'']cycloocta[1'',2
'',3'':3',4']pentaleno[1',6':5,6,7]cycloocta[1,2,3-gh:1',2',3'-
g'h']cycloocta[1,2,3-cd:5,6,7-c'd']dipentalene-
1,4,6,8,10,12,14,16,18,21,23,25,27,29,31,33-hexadecone, hexadecahydro-,
stereoisomer).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified as 1H,4H,14H,17H-
2,16:3,15-dimethano-
5H,6H,7H,8H,9H,10H,11H,12H,13H,18H,19H,20H,21H,22H,23H,24H,25H,26H-
2,3,4a,5a,6a,7a,8a,9a,10a,11a,12a,13a,15,16,17a,18a,19a,20a,21a,22a,23a,
24a,25a,26a-
tetracosaazabispentaleno[1''',6''':5'',6'',7'']cycloocta[1'',2'',3'':3',
4']pentaleno[1',6':5,6,7]cycloocta[1,2,3-gh:1',2',3'-
g'h']cycloocta[1,2,3-cd:5,6,7-c'd']dipentalene-
1,4,6,8,10,12,14,17,19,21,23,25-dodecone, dodecahydro-, stereoisomer;
2,18:3,17-dimethano-
2,3,4a,5a,6a,7a,8a,9a,10a,11a,12a,13a,14a,15a,17,18,19a,20a,21a,22a,23a,
24a,25a,26a,27a,28a,29a,30a-
octacosaazabispentaleno[1''''',6''''':5'''',
6'''',7'''']cycloocta[1'''',2'''',3'''':3''',4''']pentaleno[1''',6''':5'
',6'',7'']cycloocta[1'',2'',3'':3',4']pentaleno[1',6':5,6,7]cycloocta[1,
2,3-cd:1',2',3'-gh]pentalene-1,4,6,8,10,12,14,16,19,21,23,25,27,29-
tetradecone, tetradecahydro-, stereoisomer; 2,20:3,19-dimethano-
2,3,4a,5a,6a,7a,8a,9a,10a,11a,12a,13a,14a,15a,16a,17a,19,20,21a,22a,23a,
24a,25a,26a,27a,28a,29a,30a,31a,32a,33a,34a-
dotriacontaazabispentaleno[1''''',6''''':5'''',6'''',7'''']cycloocta[1''
'',2'''',3'''':3''',4''']pentaleno[1''',6''':5'',6'',7'']cycloocta[1'',2
'',3'':3',4']pentaleno[1',6':5,6,7]cycloocta[1,2,3-gh:1',2',3'-
g'h']cycloocta[1,2,3-cd:5,6,7-c'd']dipentalene-
1,4,6,8,10,12,14,16,18,21,23,25,27,29,31,33-hexadecone, hexadecahydro-,
stereoisomer (PMN P-22-158; CASRNs 283175-97-3; 259886-50-5; 259886-51-
6) are 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 substances after they
have been incorporated into a polymer matrix, or when incorporated into
a consumer product at or below 1.7% by weight (calculated by the weight
of all three substances combined) and packaged as a consumer product.
(2) The significant new uses are:
(i) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(3)(iii), and (g)(5). Alternative hazard
and warning statements that meet the criteria of the Globally
Harmonized System and OSHA Hazard Communication Standard may be used.
(ii) Industrial, commercial, and consumer activities. It is a
significant new use to process for use or use the substances in a
consumer product unless the concentration of the substances combined
does not exceed 1.7% by weight in the consumer product.
(iii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N=18.
(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 (c), (f) through (i), and (k) are applicable to
manufacturers, importers, and processors of these substances.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12229 Multi-walled carbon nanotubes.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as multi-walled carbon
nanotubes (PMN P-22-163) is subject to reporting under this section for
the significant new uses described in paragraph (a)(2) of this section.
The requirements of this section do not apply to quantities of the
substance after they have been embedded or incorporated into a polymer
matrix that itself has been reacted (cured); when embedded in a
permanent solid polymer form that is not intended to undergo further
processing; or when incorporated into an article. These exemptions
apply unless/until the polymer matrix or article has been shredded or
processed such that dust containing the substance is generated. Once
the matrix or article containing the substance is shredded or processed
such that dust containing the substance is generated, the requirements
of this section apply.
(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 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 50 at the confidential
site listed in the Order or at sites where batteries or the other
confidential items listed in the Order containing the PMN substance are
only recycled, or an APF of at least 1,000 at all other sites, prior
[[Page 34499]]
to the receipt of exposure monitoring results, and in accordance with
Table 2 of the Order once exposure monitoring results are available.
(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: eye
irritation, genetic toxicity, carcinogenicity, and specific target
organ toxicity. Alternative hazard and warning statements that meet the
criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f). It is a significant new use to use the
substance other than as an additive used in battery manufacture. It is
a significant new use to process the substance without the use of
engineering controls with an overall minimum efficiency of 94%. It is a
significant new use to process for use or use the substance in the
final battery when the concentration of the substance exceeds the
confidential concentration listed in the Order.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i), and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12230 Mixed metal oxide (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as mixed
metal oxide (PMNs P-22-187 and P-24-88) is subject to reporting under
this section for the significant new uses described in paragraph (a)(2)
of this section. The requirements of this section do not apply to
quantities of the substance after they have been entrained in cured
coating.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(3) through (5), (b), 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 10.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), and (5). For purposes of Sec.
721.72(g)(1), this substance may cause: specific target organ toxicity
and carcinogenicity. Alternative hazard and warning statements that
meet the criteria of the Globally Harmonized System and Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the substance in a
solid form other than when using dust controls with a capture and
control efficiency of >97%.
(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 (j) 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. 721.12231 Rosin, fumarated, polymer with adipic acid and
glycerol.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as rosin, fumarated,
polymer with adipic acid and glycerol (PMN P-23-96; CASRN 2888640-13-7)
is subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (3), and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible.
(ii) Hazard communication. Requirements as specified in 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: eye
irritation and skin sensitization. Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System and
OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o).
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N=330.
(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 (i), and (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. 721.12232 Derivatives of fats and oils, plant based, polycyclic
acids functionalized, aromatic acids, polyester with diols and triols
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
derivatives of fats and oils, plant based, polycyclic acids
functionalized, aromatic acids, polyester with diols and triols (PMN P-
23-99) is subject to reporting under this section for the significant
new uses described in paragraph (a)(2) of this section. The
requirements of this section do not apply to quantities of the
substance after they have been completely reacted or cured.
(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 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 10.
(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: skin
irritation, eye irritation, skin
[[Page 34500]]
sensitization, reproductive toxicity, and specific target organ
toxicity. Alternative hazard and warning statements that meet the
criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o). It is a significant new use to use the
substance in spray applications.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=21. For purposes of
721.91(a)(7), the control technology is primary and secondary
wastewater treatment as defined in 40 CFR part 133 and the percentage
removal of the substance resulting from use of the specified control
technology is 90%.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i), and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12233 Multi-walled carbon nanotubes.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as multi-walled carbon
nanotubes (PMN P-23-105) is subject to reporting under this section for
the significant new uses described in paragraph (a)(2) of this section.
The requirements of this section do not apply to quantities of the
substance after they have been completely entrained or incorporated
into an article.
(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 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 1000.
(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: eye
irritation, skin sensitization, respiratory sensitization, specific
target organ toxicity, reproductive toxicity, genetic toxicity, and
carcinogenicity. Alternative hazard and warning statements that meet
the criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f), (k), (o), and (t). It is a significant
new use to manufacture, process, or use the substance in solid form
unless using engineering controls with a minimum efficiency of 95%
capture and 99% control. Engineering controls are not needed when the
substance is in liquid solution or dispersion. It is a significant new
use to manufacture, process, or use the substance unless the
confidential residual listed in the Order is present at the
confidential limit listed in the Order or less by weight.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i), and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12234 Polysubstitutedcarbocycle, polyhydroxy, polyalkyl
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
polysubstitutedcarbocycle, polyhydroxy, polyalkyl (PMN P-23-156) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in 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 50, or 1000 if spray
applied.
(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: respiratory
sensitization, skin sensitization, and specific target organ toxicity.
Alternative hazard and warning statements that meet the criteria of the
Globally Harmonized System and OSHA Hazard Communication Standard may
be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f). It is a significant new use to process
for use or use the substance in a consumer product where the
concentration of the substance is equal to or exceeds the confidential
percentage in formulation listed in the Order.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N=19.
(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 (i), and (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. 721.12235 Cashew, nutshell liq., polymer with epichlorohydrin
and glycol (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as cashew,
nutshell liq., polymer with epichlorohydrin and glycol (PMN P-24-45) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section. The requirements of this
section do not apply to quantities of the substance after they have
been completely reacted or cured.
(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 which
persons are reasonably likely to be exposed as
[[Page 34501]]
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 50.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), and (5). For purposes of Sec.
721.72(g)(1), this substance may cause: skin irritation, eye
irritation, reproductive toxicity, and specific target organ toxicity.
Alternative hazard and warning statements that meet the criteria of the
Globally Harmonized System and OSHA Hazard Communication Standard may
be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o). It is a significant new use to spray
apply the substance.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers, importers, and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12236 Fatty acids, reaction products with alkene polyamine
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as fatty
acids, reaction products with alkene polyamine (PMN P-24-54) is subject
to reporting under this section for the significant new uses described
in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(3), and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible.
(ii) Hazard communication. Requirements as specified in 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: eye corrosion, skin
corrosion, skin sensitization, and specific target organ toxicity.
Alternative hazard and warning statements that meet the criteria of the
Globally Harmonized System and OSHA Hazard Communication Standard may
be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(g) and (o). It is a significant new use to
manufacture, process, or use the substance in any manner that results
in inhalation exposure to the substance.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i), and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12237 Fatty acids, reaction products with alkene polyamine
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as fatty
acids, reaction products with alkene polyamine (PMN P-24-55) is subject
to reporting under this section for the significant new uses described
in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(3), and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible.
(ii) Hazard communication. Requirements as specified in 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: eye
corrosion, skin corrosion, skin sensitization, and specific target
organ toxicity. Alternative hazard and warning statements that meet the
criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(g) and (o). It is a significant new use to
manufacture, process, or use the substance in any manner that results
in inhalation exposure to the substance.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i), and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12238 Fatty acids, reaction products with alkene polyamine
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as fatty
acids, reaction products with alkene polyamine (PMN P-24-56) is subject
to reporting under this section for the significant new uses described
in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(3), and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible.
(ii) Hazard communication. Requirements as specified in 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: eye corrosion, skin
corrosion, skin sensitization, and specific target organ toxicity.
Alternative hazard and warning statements that meet the criteria of the
Globally Harmonized System and OSHA Hazard Communication Standard may
be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(g) and (o). It is a significant new use to
manufacture,
[[Page 34502]]
process, or use the substance in any manner that results in inhalation
exposure to the substance.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i), and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12239 Functionalized fatty acids, reaction products with
alkene polyamines (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
functionalized fatty acids, reaction products with alkene polyamines
(PMN P-24-58) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1) and (3) and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible.
(ii) Hazard communication. Requirements as specified in 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: acute
toxicity, serious eye damage, skin corrosion, skin sensitization, and
specific target organ toxicity. Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System and
OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(g) and (o). It is a significant new use to
manufacture, process, or use the substance in any manner that results
in inhalation exposure to the substance.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12240 Functionalized fatty acids, reaction products with
alkene polyamines (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
functionalized fatty acids, reaction products with alkene polyamines
(PMN P-24-59) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(3), and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible.
(ii) Hazard communication. Requirements as specified in 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: acute toxicity,
serious eye damage, skin corrosion, skin sensitization, and specific
target organ toxicity. Alternative hazard and warning statements that
meet the criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(g) and (o). It is a significant new use to
manufacture, process, or use the substance in any manner that results
in inhalation exposure to the substance.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12241 Substitutedheterocyclic onium compound, salt with
fluoropolysubstitutedalkyl substitutedtricycloalkane carboxylate (1:1),
polymer with 4-ethenyl-2-methoxylphenol and
fluorosubstitutedaromaticalkyl 2-methyl-2-propenoate, di-Me 2,2'-(1,2-
diazenediyl)bis[2-methylpropanoate]-initiated (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
substitutedheterocyclic onium compound, salt with
fluoropolysubstitutedalkyl substitutedtricycloalkane carboxylate (1:1),
polymer with 4-ethenyl-2-methoxylphenol and
fluorosubstitutedaromaticalkyl 2-methyl-2-propenoate, di-Me 2,2'-(1,2-
diazenediyl)bis[2-methylpropanoate]-initiated (PMN P-24-98) is subject
to reporting under this section for the significant new uses described
in paragraph (a)(2) of this section. The requirements of this section
do not apply to quantities of the substance after they have been
completely reacted or adhered (during photolithographic processes) onto
a semiconductor wafer surface or similar manufactured article used in
the production of semiconductor technologies.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i) and (iii), (a)(3), and (c). When determining
which persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(2)(i) through (iii) and (g)(v),
(g)(3)(i) and (ii), and (g)(5). For purposes of Sec. 721.72(e), the
concentration is set at 1.0% by weight or volume. For purposes of Sec.
721.72(g)(1), this substance may cause: acute toxicity, skin
irritation, serious eye damage, skin sensitization, genetic toxicity,
and specific target organ toxicity. Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System and
OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as
[[Page 34503]]
specified in Sec. 721.80(f), (k), and (t). It is a significant new use
to import the substance other than in solution unless in sealed
containers weighing 5 kilograms or less. It is a significant new use to
process the substance in any way that generates vapor, dust, mist, or
aerosol in a non-enclosed process. It is a significant new use to
manufacture the substance longer than 9 months.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers, importers, and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12242 Dibenzothiophenium, 5-phenyl-, salt with
fluoroheterosubstitutedalkyl
heterosubstitutedhalosubstitutedaromatichydrocarboncarboxylate (1:1),
polymer with 3- ethenylphenol and fluorocarbomonocyclealkyl 2-methyl-2-
propenoate (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
dibenzothiophenium, 5-phenyl-, salt with fluoroheterosubstitutedalkyl
heterosubstitutedhalosubstitutedaromatichydrocarboncarboxylate (1:1),
polymer with 3- ethenylphenol and fluorocarbomonocyclealkyl 2-methyl-2-
propenoate (PMN P-25-60) is subject to reporting under this section for
the significant new uses described in paragraph (a)(2) of this section.
The requirements of this section do not apply to quantities of the
substance after they have been completely reacted or adhered (during
photolithographic processes) onto a semiconductor wafer surface or
similar manufactured article used in the production of semiconductor
technologies.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i) and (iii), (a)(3), and (c). When determining
which persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(2)(i) through (iii) and (g)(v),
(g)(3)(i) and (ii), and (g)(5). For purposes of Sec. 721.72(e), the
concentration is set at 1.0% by weight or volume. For purposes of Sec.
721.72(g)(1), this substance may cause: acute toxicity, skin
irritation, serious eye damage, skin sensitization, genetic toxicity,
and specific target organ toxicity. Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System and
OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f), (k), and (t). It is a significant new
use to import the substance other than in solution unless in sealed
containers weighing 5 kilograms or less. It is a significant new use to
process the substance in any way that generates vapor, dust, mist, or
aerosol in a non-enclosed process. It is a significant new use to
manufacture the substance longer than 9 months.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers, importers, and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12243 Dibenzothiophenium, 5-phenyl-, salt with
fluoroheterosubstitutedalkyl
heterosubstitutedhalosubstitutedaromatichydrocarboncarboxylate (1:1),
polymer with 3- ethenylphenol and alkylcycloalkyl 2-methyl-2-propenoate
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
dibenzothiophenium, 5-phenyl-, salt with fluoroheterosubstitutedalkyl
heterosubstitutedhalosubstitutedaromatichydrocarboncarboxylate (1:1),
polymer with 3- ethenylphenol and alkylcycloalkyl 2-methyl-2-propenoate
(PMN P-25-64) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section. The
requirements of this section do not apply to quantities of the
substance after they have been completely reacted or adhered (during
photolithographic processes) onto a semiconductor wafer surface or
similar manufactured article used in the production of semiconductor
technologies.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i) and (iii), (a)(3), and (c). When determining
which persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(2)(i) through (iii) and (g)(v),
(g)(3)(i) and (ii), and (g)(5). For purposes of Sec. 721.72(e), the
concentration is set at 1.0% by weight or volume. For purposes of Sec.
721.72(g)(1), this substance may cause: acute toxicity, skin
irritation, serious eye damage, skin sensitization, genetic toxicity,
and specific target organ toxicity. Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System and
OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f), (k), and (t). It is a significant new
use to import the substance other than in solution unless in sealed
containers weighing 5 kilograms or less. It is a significant new use to
process the substance in any way that generates vapor, dust, mist, or
aerosol in a non-enclosed process. It is a significant new use to
manufacture the substance longer than 9 months.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers, importers, and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12244 Lithium dihalo (oxalato)borate(1-) (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as lithium
dihalo (oxalato)borate(1-) (PMN P-24-109) is subject to reporting under
this section for the significant new uses described in paragraph (a)(2)
of this section. The requirements of this section do not apply to
quantities of the substance after they have been sealed in a battery.
(2) The significant new uses are:
[[Page 34504]]
(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 10.
(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: acute
toxicity, skin irritation, skin sensitization, serious eye damage,
reproductive toxicity, and specific target organ toxicity. Alternative
hazard and warning statements that meet the criteria of the Globally
Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o).
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=1.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12245 Carbamodithioic acid, N,N-bis(phenylmethyl)-, compd.
with 2,2'-dithiobis[ethanamine] (2:1).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as carbamodithioic
acid, N,N-bis(phenylmethyl)-, compd. with 2,2'-dithiobis[ethanamine]
(2:1) (PMN P-24-112; CAS No. 239446-62-9) is subject to reporting under
this section for the significant new uses described in paragraph (a)(2)
of this section. The requirements of this section do not apply to
quantities of the substance when completely reacted or cured.
(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 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 10.
(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: acute
toxicity, skin sensitization, reproductive toxicity, and specific
target organ toxicity. Alternative hazard and warning statements that
meet the criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o). It is a significant new use to
manufacture the substance other than by import in a pellet form into
the United States (i.e., no domestic manufacture).
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) (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. 721.12246 Benzene, [alkyl [polycycloalkyl]-yl] polyfluoro-alkyl-
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
benzene, [alkyl [polycycloalkyl]-yl] polyfluoro-alkyl- (PMN P-24-146)
is subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section. The requirements of this
section do not apply to quantities of the substance when sealed inside
a display.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(3), and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), and (5). For purposes of Sec.
721.72(g)(1), this substance may cause: specific target organ toxicity.
Alternative hazard and warning statements that meet the criteria of the
Globally Harmonized System and OSHA Hazard Communication Standard may
be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k). It is a significant new use to
manufacture, process, or use the substance other than in a liquid
solution.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12247 Substituted polyphenyl, alkyl-fluoro-alky (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
substituted polyphenyl, alkyl-fluoro-alky (PMN P-24-148) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section. The requirements of this section do
not apply to quantities of the substance after they have been
incorporated into an article.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(3), and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
engineering control measures (e.g., enclosure or confinement of the
operation, general
[[Page 34505]]
and local ventilation) or administrative control measures (e.g.,
workplace policies and procedures) shall be considered and implemented
to prevent exposure, where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), and (5). For purposes of Sec.
721.72(g)(1), this substance may cause: reproductive toxicity and
specific target organ toxicity. Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System and
OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) and (o). It is a significant new use to
manufacture, process, or use the substance in any manner that generates
a vapor, mist, dust, or aerosol containing the substance.
(iv) Disposal. It is a significant new use to dispose of the
substance, or waste streams containing the substance, by incineration
other than by hazardous waste incineration in compliance with RCRA
subtitle C, incineration above 1,000 degrees C for at least two
seconds.
(v) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in 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. 721.12248 Substituted polyphenyl, alkyl-polyfluoro-alkyl-
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
substituted polyphenyl, alkyl-polyfluoro-alkyl (PMN P-24-149) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section. The requirements of this
section do not apply to quantities of the substance after they have
been incorporated into an article.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(3), and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), and (5). For purposes of Sec.
721.72(g)(1), this substance may cause: reproductive toxicity and
specific target organ toxicity. Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System and
OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) and (o). It is a significant new use to
manufacture, process, or use the substance in any manner that generates
a vapor, mist, dust, or aerosol containing the substance.
(iv) Disposal. It is a significant new use to dispose of the
substance, or waste streams containing the substance, by incineration
other than by hazardous waste incineration in compliance with RCRA
subtitle C, incineration above 1,000 degrees C for at least two
seconds.
(v) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in 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. 721.12249 Substituted polyphenyl, alkyl-alkyl-polyfluoro-
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
substituted polyphenyl, alkyl-alkyl-polyfluoro- (PMN P-24-150) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section. The requirements of this
section do not apply to quantities of the substance after they have
been incorporated into an article.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(3), and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), and (5). For purposes of Sec.
721.72(g)(1), this substance may cause: reproductive toxicity and
specific target organ toxicity. Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System and
OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) and (o). It is a significant new use to
manufacture, process, or use the substance in any manner that generates
a vapor, mist, dust, or aerosol containing the substance.
(iv) Disposal. It is a significant new use to dispose of the
substance, or waste streams containing the substance, by incineration
other than by hazardous waste incineration in compliance with RCRA
subtitle C, incineration above 1,000 degrees C for at least two
seconds.
(v) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in 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. 721.12250 Substituted polyphenyl, alkyl-alkyl-fluoro- (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
substituted polyphenyl, alkyl-alkyl-fluoro- (PMN P-24-151) 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 they have been
incorporated into an article.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in
[[Page 34506]]
Sec. 721.63(a)(1), (a)(3), and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), and (5). For purposes of Sec.
721.72(g)(1), this substance may cause: reproductive toxicity and
specific target organ toxicity. Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System and
OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) and (o). It is a significant new use to
manufacture, process, or use the substance in any manner that generates
a vapor, mist, dust, or aerosol containing the substance.
(iv) Disposal. It is a significant new use to dispose of the
substance, or waste streams containing the substance, by incineration
other than by hazardous waste incineration in compliance with RCRA
subtitle C, incineration above 1,000 degrees C for at least two
seconds.
(v) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in 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. 721.12251 Phenyl carboxylic acid, alkylcycloalkyl,
phenylalkanediyl ester (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as phenyl
carboxylic acid, alkylcycloalkyl, phenylalkanediyl ester (PMN P-24-152)
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 they have
been incorporated into an article.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(3), and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), and (5). For purposes of Sec.
721.72(g)(1), this substance may cause: specific target organ toxicity.
Alternative hazard and warning statements that meet the criteria of the
Globally Harmonized System and OSHA Hazard Communication Standard may
be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) and (o). It is a significant new use to
manufacture, process, or use the substance in any manner that generates
a vapor, mist, dust, or aerosol containing the substance.
(iv) Disposal. It is a significant new use to dispose of the
substance, or waste streams containing the substance, by hazardous
waste landfill other than at a facility that is in compliance with RCRA
Subtitle C.
(v) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in 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. 721.12252 Fluoro substituted polyphenyl alkyl (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as fluoro
substituted polyphenyl alkyl (PMN P-24-153) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section. The requirements of this section do not apply
to quantities of the substance after they have been incorporated into
an article.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(3), and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), and (5). For purposes of Sec.
721.72(g)(1), this substance may cause: reproductive toxicity and
specific target organ toxicity. Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System and
OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) and (o). It is a significant new use to
manufacture, process, or use the substance in any manner that generates
a vapor, mist, dust, or aerosol containing the substance.
(iv) Disposal. It is a significant new use to dispose of the
substance, or waste streams containing the substance, by incineration
unless hazardous waste incineration in compliance with RCRA Subtitle C,
incineration above 1,000 degrees C for at least two seconds is used.
(v) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in 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. 721.12253 Polyphenyl, ethoxy-polyfluoro-alkyl- (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
polyphenyl, ethoxy-polyfluoro-alkyl- (PMN P-24-154) 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
[[Page 34507]]
apply to quantities of the substance after they have been incorporated
into an article.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(3), and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible.
(ii) Hazard communication. Requirements as specified in 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: specific
target organ toxicity. Alternative hazard and warning statements that
meet the criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) and (o). It is a significant new use to
manufacture
[…truncated; see source link]Indexed from Federal Register on June 5, 2026.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.