Significant New Use Rules on Certain Chemical Substances (26-1)
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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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<title>Federal Register, Volume 91 Issue 111 (Wednesday, June 10, 2026)</title>
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<body><pre>
[Federal Register Volume 91, Number 111 (Wednesday, June 10, 2026)]
[Proposed Rules]
[Pages 35156-35173]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-11593]
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Proposed Rules
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
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Federal Register / Vol. 91, No. 111 / Wednesday, June 10, 2026 /
Proposed Rules
[[Page 35156]]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[EPA-HQ-OPPT-2026-0499; FRL-13317-01-OCSPP]
RIN 2070-AB27
Significant New Use Rules on Certain Chemical Substances (26-1)
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 10, 2026.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2026-0499, 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: Jordan Garbin, New Chemicals Division
(7405M), Office of Pollution Prevention and Toxics, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; telephone number: (202) 564-4156; email address:
<a href="/cdn-cgi/l/email-protection#eb8c8a99898285c58184998f8a85ab8e9b8ac58c849d"><span class="__cf_email__" data-cfemail="c7a0a6b5a5aea9e9ada8b5a3a6a987a2b7a6e9a0a8b1">[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#4d3a343e22232a633a242121242c200d283d2c632a223b"><span class="__cf_email__" data-cfemail="196e606a76777e376e707575707874597c6978377e766f">[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#491d1a0a086401263d2520272c092c3928672e263f"><span class="__cf_email__" data-cfemail="c195928280ec89aeb5ada8afa481a4b1a0efa6aeb7">[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 Exporters
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 707.20. Importers of chemical substances in bulk form, as part of a
mixture, or as part of an article (if required by rule) must certify
that the shipment of the chemical substance complies with all
applicable rules and Orders under TSCA, including regulations issued
under TSCA sections 5, 6, 7 and Title IV.
Pursuant to 40 CFR 721.20, any persons who export or intend to
export a chemical substance that is the subject of this proposed rule
on or after July 10, 2026 are subject to TSCA section 12(b) (15 U.S.C.
2611(b)) and must comply with the export notification requirements in
40 CFR part 707, subpart D.
D. What are the incremental economic impacts of this action?
EPA has evaluated the potential costs of establishing Significant
New Use Notice (SNUN) reporting requirements for potential
manufacturers (including importers) and processors of the chemical
substances subject to these proposed SNURs. This analysis, which is
available in the docket, is briefly summarized here.
1. Estimated Costs for SNUN Submissions
If a SNUN is submitted, costs are an estimated $45,496 per SNUN
submission for large business submitters and $14,976 for small business
submitters. These estimates include the cost to prepare and submit the
SNUN (including registration for EPA's Central
[[Page 35157]]
Data Exchange (CDX)), and the payment of a user fee. Businesses that
submit a SNUN would be subject to either a $37,000 user fee required by
40 CFR 700.45(c)(2)(ii) and (d), or, if they are a small business as
defined at 13 CFR 121.201, a reduced user fee of $6,480 (40 CFR
700.45(c)(1)(ii) and (d)). The costs of submission for SNUNs will not
be incurred by any company unless a company decides to pursue a
significant new use as defined in these SNURs. Additionally, these
estimates reflect the costs and fees as they are known at the time of
this rulemaking.
2. Estimated Costs for Export Notifications
EPA has also evaluated the potential costs associated with the
export notification requirements under TSCA section 12(b) and the
implementing regulations at 40 CFR part 707, subpart D. For persons
exporting a substance that is the subject of a SNUR, a one-time notice
to EPA must be provided for the first export or intended export to a
particular country. The total costs of export notification will vary by
chemical, depending on the number of required notifications (i.e., the
number of countries to which the chemical is exported). While EPA is
unable to make any estimate of the likely number of export
notifications for the chemical substances covered by these SNURs, as
stated in the accompanying economic analysis, the estimated cost of the
export notification requirement on a per-unit basis is approximately
$106.
E. What should I consider as I prepare my comments for EPA?
1. Submitting CBI
Do not submit CBI to EPA through email or <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/dockets/commenting-epa-dockets">https://www.epa.gov/dockets/commenting-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 are based on Orders issued to certain
companies for substances that were the subject of PMN submissions.
Those Orders were issued under TSCA section 5(e)(1)(A), as required by
the determinations made under TSCA section 5(a)(3)(B). The TSCA Orders
require protective measures to limit exposures or otherwise mitigate
the potential unreasonable risk. The proposed SNURs extend those
protective measures to any person intending to manufacture, process,
use, distribute in commerce, or dispose of the new chemical substances
subject to Orders and identify as significant new uses any
manufacturing, processing, use, distribution in commerce, or disposal
that does not conform to the restrictions imposed by the underlying
TSCA Orders, consistent with TSCA section 5(f)(4).
B. Rationale and Objectives of the SNURs
1. Rationale
Under TSCA section 5(a)(1)(B), no person may manufacture a new
chemical substance or manufacture or process a chemical substance for a
significant new use until EPA makes a determination as described in
TSCA section 5(a)(3) and takes any required action. The issuance of a
SNUR is not a risk determination itself, only a notification
requirement for ``significant new uses,'' so that the Agency has the
opportunity to review the SNUN for the significant new use and make a
TSCA section 5(a)(3) risk determination.
During review of the PMNs submitted that identify chemical
substances subject to these proposed SNURs, EPA concluded that
regulation was warranted under TSCA section 5(e), pending the
development of information sufficient to make reasoned evaluations of
the health or environmental effects of the chemical substances. Based
on the findings outlined in Unit III., TSCA section 5(e) Orders
requiring the use of appropriate exposure controls were negotiated with
the PMN submitters. As a general matter, EPA believes it is necessary
to follow a TSCA Order with a SNUR that identifies the absence of those
protective measures as significant new uses to ensure that all
manufacturers and processors, not just the party subject to a TSCA
Order, are held to the same standard.
2. Objectives
EPA is proposing these SNURs because the Agency has determined it
is appropriate:
<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
[[Page 35158]]
determine if a chemical substance is on the TSCA Inventory is available
at <a href="https://www.epa.gov/tsca-inventory">https://www.epa.gov/tsca-inventory</a>.
C. Significant New Uses Claimed as CBI
EPA is proposing to establish certain significant new uses which
have been claimed as CBI subject to Agency confidentiality regulations
at 40 CFR parts 2 and 703. Absent a final determination or other
disposition of the confidentiality claim under these regulations, EPA
is required to keep this information confidential. EPA promulgated a
procedure at 40 CFR 721.11 to deal with the situation where a specific
significant new use is CBI. Under these procedures, a manufacturer or
processor may ask EPA to identify the confidential significant new use
subject to the SNUR. The manufacturer or processor must show that it
has a bona fide intent to manufacture or process the chemical
substance. If EPA concludes that the person has shown a bona fide
intent to manufacture or process the chemical substance, EPA will
identify the confidential significant new use to that person. Since
most of the chemical identities of the chemical substances subject to
these SNURs are also CBI, manufacturers and processors can combine the
bona fide submission under the procedure in 40 CFR 721.11 into a single
step.
D. Applicability of General Provisions
General provisions for SNURs appear in 40 CFR part 721, subpart A.
These provisions describe persons subject to SNURs, recordkeeping
requirements, exemptions to reporting requirements, and applicability
of the rule to uses occurring before the effective date of the rule.
Pursuant to 40 CFR 721.1(c), persons subject to SNURs must comply with
the same requirements and EPA regulatory procedures as submitters of
PMNs under TSCA section 5(a)(1)(A). In particular, these requirements
include the information submission requirements of TSCA sections 5(b)
and 5(d)(1), the exemptions authorized by TSCA sections 5(h)(1),
5(h)(2), 5(h)(3), and 5(h)(5), and the regulations at 40 CFR part 720.
In addition, provisions relating to user fees appear at 40 CFR part
700.
Once EPA receives a SNUN, EPA must either determine that the
significant new use is not likely to present an unreasonable risk of
injury under the conditions of use for the chemical substance or take
such regulatory action as is associated with an alternative
determination under TSCA section 5 before the manufacture (including
import) or processing for the significant new use can commence. If EPA
determines that the significant new use of the chemical substance is
not likely to present an unreasonable risk, EPA is required under TSCA
section 5(g) to make public, and submit for publication in the Federal
Register, a statement of EPA's findings.
As discussed in Unit I.C.2., persons who export or intend to export
a chemical substance identified in a proposed or final SNUR are subject
to the export notification provisions of TSCA section 12(b), and
persons who import a chemical substance identified in a final SNUR are
subject to the TSCA section 13 import certification requirements. See
also <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
[[Page 35159]]
only means of providing information to evaluate the chemical substance
associated with the significant new uses. However, submitting a SNUN
without any test data may increase the likelihood that EPA will take
action under TSCA sections 5(e) or 5(f). EPA recommends that potential
SNUN submitters contact EPA early enough so that they will be able to
conduct the appropriate tests.
SNUN submitters should be aware that EPA will be better able to
evaluate SNUNs that provide detailed information about human exposure
and environmental release that may result from the significant new use
of the chemical substances.
III. Chemical Substances Subject to These Proposed SNURs
A. What is the designated cutoff date for ongoing uses?
EPA designates Error! Reference source not found. June 10, 2026 as
the cutoff date for determining whether the new use is ongoing. This
designation is explained in more detail in Unit II.E.
B. What information is provided for each chemical substance?
For each chemical substance identified in Unit III.C., EPA provides
the following information:
<bullet> PMN number (the proposed CFR citation assigned in the
regulatory text section of this document).
<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 corresponding 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).
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-20-174 (40 CFR 721.12260)
Chemical Name: 6-Octen-1-ol, 3,7-dimethyl-, homopolymer,
monoacetate.
CASRN: 2417284-25-2.
Effective Date of TSCA Order: October 27, 2025.
Basis for TSCA Order: The PMN states that the use will be as a
solubilizer and rheology modifier for use in consumer products,
including but not limited to laundry detergents, cleaners, fabric
softeners, air fresheners, etc. Based on comparison to analogous
chemical substances, EPA has identified concerns for systemic effects.
The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and
5(e)(1)(A)(ii)(I), based on a finding that, in the absence of
sufficient information to permit a reasoned evaluation, the substance
may present an unreasonable risk of injury to human health. To protect
against these risks, the Order requires:
<bullet> Manufacture, processing, or use of the PMN substance only
in a manner that does not result in inhalation exposure to the PMN
substance. This requirement does not apply to use in consumer products.
<bullet> No release of the PMN substance, or any waste stream
containing the PMN substance, resulting in surface water concentrations
that exceed 669 parts per billion; and
<bullet> Establishment of a hazard communication program, including
human health and environmental precautionary statements on each label
and in the Safety Data Sheet (SDS).
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of
specific target organ toxicity testing may be potentially useful to
characterize the health effects of the PMN substance. Although the
Order does not require these tests, the Order's restrictions remain in
effect until the Order is modified or revoked by EPA based on
submission of this or other relevant information.
P-21-104 (40 CFR 721.12261) and P-21-105 (40 CFR 721.12262)
Chemical Names: Alkanedioic acid, di branched alkyl esters
(generic) (P-21-104) and alkanedioic acid, di C11-14 isoalkyl esters
(generic) (P-21-105).
Accession Nos.: 303674 (P-21-104) and 303663 (P-21-105).
Effective Date of TSCA Order: December 1, 2025.
Basis for TSCA Order: The PMNs state that the generic (non-
confidential) uses will be as lubricants. Based on comparison to
analogous chemical substances, EPA has identified concerns for skin
irritation, eye irritation, and systemic effects. The Order was issued
under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a
finding that, in the absence of sufficient information to permit a
reasoned evaluation, the substances may present an unreasonable risk of
injury to human health. To protect against these risks, the Order
requires:
<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> 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 SNURs would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of skin
irritation, eye irritation, and specific target organ toxicity testing
may be potentially useful to characterize the health effects of the PMN
substances. Although the Order does not require these tests, the
Order's restrictions remain in effect until the Order is modified or
revoked by EPA based on submission of this or other relevant
information.
P-21-166 (40 CFR 721.12263)
Chemical Name: Siloxanes and Silicones, di-Me, [alkylpiperazinium-
[[Page 35160]]
hydroxyalkoxy]alkyl group-terminated, arylsulfonates (salts) (generic).
CASRN or Accession No.: Not available.
Effective Date of TSCA Order: September 13, 2025.
Basis for TSCA Order: The PMN states that the use will be as a
textile softening agent. Based on comparison to analogous chemical
substances, EPA has identified concerns for systemic and respiratory
hazards and skin sensitization. Based on comparison to analogous
polycationic polymers, EPA predicts toxicity to aquatic organisms may
occur at concentrations that exceed 9 parts per billion. The Order was
issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I),
based on a finding that, in the absence of sufficient information to
permit a reasoned evaluation, the substance may present an unreasonable
risk of injury to human health and the environment. To protect against
these risks, the Order requires:
<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> Manufacture, processing, and use of the PMN substance only
in the form of a liquid solution;
<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 9 parts per billion; 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
sensitization, pulmonary effects, specific target organ toxicity, and
aquatic toxicity testing may be potentially useful to characterize the
health and environmental effects of the PMN substance. Although the
Order does not require these tests, the Order's restrictions remain in
effect until the Order is modified or revoked by EPA based on
submission of this or other relevant information.
P-21-167 (40 CFR 721.12264)
Chemical Name: Siloxanes and silicones, di-Me, [alkylpiperazinium-
hydroxyalkoxy]alkyl group- and (hydroxyalkoxy)alkyl group-terminated,
ethers with polyethylene glycol alkyl ethers, arylsulfonates (salts)
(generic).
CASRN or Accession No.: Not available.
Effective Date of TSCA Order: September 13, 2025.
Basis for TSCA Order: The PMN states that the use will be as a
textile softening agent. Based on comparison to analogous chemical
substances, EPA has identified concerns for systemic and respiratory
hazards and skin sensitization. Based on comparison to analogous
polycationic polymers, EPA predicts toxicity to aquatic organisms may
occur at concentrations that exceed 0.7 parts per billion. The Order
was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I),
based on a finding that, in the absence of sufficient information to
permit a reasoned evaluation, the substance may present an unreasonable
risk of injury to human health and the environment. To protect against
these risks, the Order requires:
<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> Manufacture, processing, and use of the PMN substance only
in the form of a liquid solution;
<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 0.7 parts per billion; 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
sensitization, pulmonary effects, specific target organ toxicity, and
aquatic toxicity testing may be potentially useful to characterize the
health and environmental effects of the PMN substance. Although the
Order does not require these tests, the Order's restrictions remain in
effect until the Order is modified or revoked by EPA based on
submission of this or other relevant information.
P-23-78 (40 CFR 721.12265)
Chemical Name: Soybean oil, polymer with diethylene glycol- and
glycerol- and tetraethylene glycol- and triethylene glycol-depolymd.
poly(ethylene terephthalate) waste plastics, 3-hydroxy-2-
(hydroxymethyl)-2-methylpropanoic acid and phthalic anhydride.
CASRN: 2803562-50-5.
Effective Date of TSCA Order: September 18, 2025.
Basis for TSCA Order: The PMN states that the use will be as a
polyester polyol which will be used in combination with other
ingredients to make the B side of a spray polyurethane foam formulation
(the A side (isocyanate) and B side are reacted together to produce a
polyurethane foam that is used as insulation in buildings). Based on
structure, EPA has identified concerns for lung effects (surfactant
effects) and eye and respiratory tract irritation. Based on test data
for metabolites/ester hydrolysis products and feedstock residuals, EPA
has also identified concerns for skin irritation and systemic,
neurotoxic, reproductive, and developmental effects. Based on
comparison to analogous esters and submitted test data on the PMN
substance, EPA predicts toxicity to aquatic organisms may occur at
concentrations that exceed 58 parts per billion. The Order was issued
under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a
finding that, in the absence of sufficient information to permit a
reasoned evaluation, the substance may present an unreasonable risk of
injury to human health and the environment. To protect against these
risks, the Order requires:
<bullet> Use of personal protective equipment where there is a
potential for dermal exposure;
<bullet> Use of a National Institute for Occupational Safety and
Health (NIOSH)-certified respirator with an Assigned Protection Factor
(APF) of at least 1,000 where there is a potential for inhalation
exposure;
<bullet> No processing for use or use of the PMN substance in a
consumer product;
<bullet> Use of the PMN substance only if all of the following are
true: (1) The PMN substance is used in the B side (polyol) of a spray
polyurethane foam
[[Page 35161]]
formulation, (2) the concentration of the PMN substance does not exceed
the confidential percentage by weight on the B side listed in the
Order, and (3) the PMN substance is used in an application process
designed to result in instant and complete reaction of the B side
containing the PMN substance with the A side (isocyanate) such that
there is no unreacted polyol present in any overspray;
<bullet> No release of the PMN substance, or any waste stream
containing the PMN substance, resulting in surface water concentrations
that exceed 58 parts per billion; and
<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
developmental toxicity, eye irritation, metabolism or pharmacokinetics,
neurotoxicity, pulmonary effects, reproductive toxicity, skin
irritation, and specific target organ toxicity testing may be
potentially useful to characterize the health effects of the PMN
substance. Although the Order does not require these tests, the Order's
restrictions remain in effect until the Order is modified or revoked by
EPA based on submission of this or other relevant information.
P-23-138 (40 CFR 721.12266)
Chemical Name: Benzoicacid,2-([1,1'-biphenyl]-4-ylcarbonyl)-,2-
ethylhexylester.
CASRN: 75005-95-7.
Effective Date of TSCA Order: October 30, 2025.
Basis for TSCA Order: The PMN states that the use of the PMN
substance will be as a photoinitiator in cooperation with amine
synergists or amine acrylates in overprint varnishes (OPV) and
industrial coatings (pigmented systems like offset, flexo, and
inkjets). Based on the physical/chemical properties of the PMN
substance (as described in the New Chemical Program's persistent,
bioaccumulative, and toxic (PBT) category at 64 FR 60194; November
1999) and in the absence of data, the PMN substance is potentially a
PBT chemical. EPA estimates that the PMN substance will persist in the
environment for more than six months and estimates a bioaccumulation
factor of >1,000 and <5,000. Based on submitted test data on the PMN
substance, EPA has identified concerns for skin sensitization. Based on
submitted test data on the PMN substance and comparison to analogous
esters, EPA predicts toxicity to aquatic organisms may occur at
concentrations that exceed 0.8 parts per billion. The Order was issued
under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a
finding that, in the absence of sufficient information to permit a
reasoned evaluation, the substance may present an unreasonable risk of
injury to human health or the environment. To protect against these
risks, the Order requires:
<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> Use of the PMN substance only if the concentration of the
PMN substance does not exceed 5% by weight in formulation;
<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
persistence, bioaccumulation, and aquatic toxicity testing may be
potentially useful to characterize the fate and environmental effects
of the PMN substance. Although the Order does not require these tests,
the Order's restrictions remain in effect until the Order is modified
or revoked by EPA based on submission of this or other relevant
information.
P-23-183 (40 CFR 721.12267)
Chemical Name: Ethyl modified lactam (generic).
CASRN or Accession No.: Not available.
Effective Date of TSCA Order: November 12, 2025.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as an additive in paints, coatings, and inks,
wire coatings, and paint removal formulations. Based on submitted test
data on the PMN substance, EPA has identified concerns for acute
toxicity, serious eye damage, and systemic effects. The Order was
issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I),
based on a finding that, in the absence of sufficient information to
permit a reasoned evaluation, the substance may present an unreasonable
risk of injury to human health. To protect against these risks, the
Order requires:
<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 use of the PMN substance in spray applications unless
in an enclosed process;
<bullet> Disposal of the PMN substance, or waste streams containing
the PMN substance, only by incineration;
<bullet> No release of the PMN substance, or any waste stream
containing the PMN substance, resulting in surface water concentrations
that exceed 3143 parts per billion; and
<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
exposure monitoring may be potentially useful to characterize human
exposures to the PMN substance. Although the Order does not require
these tests, the Order's restrictions remain in effect until the Order
is modified or revoked by EPA based on submission of this or other
relevant information.
P-23-193 (40 CFR 721.12268)
Chemical Name: Substituted carbopolycyclic dicarboxylic acid
dialkyl ester, polymer with alkanediol, carbopolycyclic bis(substituted
carbopolycycle)bis[alkanol] and carbopolycyclic bis(substituted
carbomonocycle)bis[alkanol] (generic).
CASRN or Accession No.: Not available.
[[Page 35162]]
Effective Date of TSCA Order: September 2, 2025.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as a component of lenses used in electronic
applications. Based on the PMN substance being a high molecular weight
>10,000 Daltons) insoluble polymer, EPA has identified concerns for
lung overload. The Order was issued under TSCA sections
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that, in
the absence of sufficient information to permit a reasoned evaluation,
the substance may present an unreasonable risk of injury to human
health. To protect against these risks, the Order requires:
<bullet> Establishment of a hazard communication program, including
human health and environmental precautionary statements on each label
and in the SDS; and
<bullet> Manufacture of the PMN substance only when at least one of
the following is true: (1) the PMN substance has a mean particle size
equal to or greater than 2.5 millimeters or (2) where the percentage of
particles of the PMN substance with a diameter less than 1.4
millimeters is less than or equal to 0.01 percent by weight.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of
pulmonary effects testing may be potentially useful to characterize the
health effects of the PMN substance. Although the Order does not
require these tests, the Order's restrictions remain in effect until
the Order is modified or revoked by EPA based on submission of this or
other relevant information.
P-24-6 (40 CFR 721.12269)
Chemical Name: Polymeric salt of propenoic acid, acrylamido-
methylpropane sulfonic acid sodium salt, hydroxyethyl methacrylate,
methyl methacrylate, propenoic acid, methyl-, phosphinicobis(oxy-
ethanediyl) ester, sodium metabisulfite (generic).
CASRN or Accession No.: Not available.
Effective Date of TSCA Order: October 8, 2025.
Basis for TSCA Order: The PMN states that the use will be as an
oilfield production scale inhibitor for descaling processing equipment
and oil field applications. Based on comparison to analogous
polyanionic polymers (and monomers), EPA predicts toxicity to aquatic
organisms may occur at concentrations that exceed 316 parts per
billion. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and
5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient
information to permit a reasoned evaluation, the substance may present
an unreasonable risk of injury to the environment. To protect against
these risks, the Order requires:
<bullet> No release of the PMN substance, or any waste stream
containing the PMN substance, resulting in surface water concentrations
that exceed 316 parts per billion; and
<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 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-24-16 (40 CFR 721.12270)
Chemical Name: 2-Propanamine, N,N'-(oxydi-2,1-ethanediyl)bis[N-
methyl-.
CASRN: 2484716-03-0.
Effective Date of TSCA Order: October 1, 2025.
Basis for TSCA Order: The PMN states that the use will be as a
catalyst in two-part polyurethane spray foam insulation applications.
Based on submitted test data on the PMN substance, EPA has identified
concerns for skin corrosion. Based on comparison to analogous chemical
substances, EPA has also identified concerns for acute toxicity, eye
corrosion, and systemic and developmental effects. Based on concerns
for eye and skin corrosion, EPA has also identified concerns for
respiratory corrosion. Based on comparison to analogous aliphatic
amines and submitted test data on the PMN substance, EPA predicts
toxicity to aquatic organisms may occur at concentrations that exceed
89 parts per billion. The Order was issued under TSCA sections
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that, in
the absence of sufficient information to permit a reasoned evaluation,
the substance may present an unreasonable risk of injury to human
health and the environment. To protect against these risks, the Order
requires:
<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> Processing for use or use of the PMN substance only as a
catalyst in two-part polyurethane spray foam insulation applications;
<bullet> Processing for use or use of the PMN substance only if the
concentration of the PMN substance does not exceed 3 percent by weight
in formulation;
<bullet> No release of the PMN substance, or any waste stream
containing the PMN substance, resulting in surface water concentrations
that exceed 89 parts per billion; and
<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
corrosion, developmental toxicity, pulmonary effects, reproductive
toxicity, and specific target organ toxicity testing may be potentially
useful to characterize the health effects of the PMN substance.
Although the Order does not require these tests, the Order's
restrictions remain in effect until the Order is modified or revoked by
EPA based on submission of this or other relevant information.
P-24-20 (40 CFR 721.12271)
Chemical Name: Polyalkyl substituted amine, hydrolysis products
with alkenyltrialkoxymetalloid and silica (generic).
[[Page 35163]]
CASRN or Accession No.: Not available.
Effective Date of TSCA Order: September 5, 2025.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as a component used in the manufacture of
electronics. Based on physical/chemical properties and comparison to
analogous respirable, poorly soluble particulates, EPA has identified
concerns for lung effects (lung overload). Based on comparison to
analogous chemical substances, EPA has also identified concerns for
lung and respiratory tract effects. Due to insufficient information,
EPA was unable to estimate the environmental hazard of the PMN
substance. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I)
and 5(e)(1)(A)(ii)(I), based on a finding that, in the absence of
sufficient information to permit a reasoned evaluation, the substance
may present an unreasonable risk of injury to human health and the
environment. To protect against these risks, the Order requires:
<bullet> Use of a NIOSH-certified respirator with an APF of at
least 1,000 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 exceedance of 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
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-24-46 (40 CFR 721.12272) and P-24-47 (40 CFR 721.12273)
Chemical Names: Alkanol, alkoxyalkylimino, salt (generic) (P-24-46)
and alkanol, nitrilo, salt (generic) (P-24-47).
CASRNs or Accession Nos.: Not available.
Effective Date of TSCA Order: November 24, 2025.
Basis for TSCA Order: The PMNs state that the uses will be as
grinding aids used in cement manufacture. Based on comparison to
analogous chemical substances, EPA has identified concerns for eye
corrosion, respiratory tract irritation, and systemic and developmental
effects. Based on comparison to analogous aliphatic amines, EPA
predicts toxicity to aquatic organisms may occur at concentrations that
exceed 101 parts per billion. The Order was issued under TSCA sections
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that, in
the absence of sufficient information to permit a reasoned evaluation,
the substances may present an unreasonable risk of injury to human
health and the environment. To protect against these risks, the Order
requires:
<bullet> No manufacture, processing, or use of the PMN substances
in any manner that results in inhalation exposure to the PMN
substances;
<bullet> Manufacture, processing, and use of the PMN substances
only in liquid solution;
<bullet> No processing for use or use of the PMN substances in a
consumer product;
<bullet> Use of personal protective equipment where there is a
potential for dermal exposure;
<bullet> No release of the PMN substances, or any waste stream
containing the PMN substances, resulting in surface water
concentrations that exceed 101 parts per billion of the P-24-46 and P-
24-47 substances in aggregate; and
<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, specific target organ toxicity, pulmonary
effects, developmental toxicity, and aquatic toxicity testing may be
potentially useful to characterize the health and environmental effects
of the PMN substances. Although the Order does not require these tests,
the Order's restrictions remain in effect until the Order is modified
or revoked by EPA based on submission of this or other relevant
information.
P-24-70 (40 CFR 721.12274)
Chemical Name: Aryl-dicarboxylic acid, polymer with alkanedioic
acid, 2,2'-oxypoly[alkanol], polymethylenepolyphenylene isocyanate and
alkane diol (generic).
CASRN or Accession No.: Not available.
Effective Date of TSCA Order: November 24, 2025.
Basis for TSCA Order: The PMN states that the use will be as an
adhesive sealant foam for use in construction. Based on comparison to
analogous diisocyanates, EPA has identified concerns for acute
toxicity, irritation to the skin, eyes, and respiratory tract, skin
sensitization, respiratory sensitization, and pulmonary effects. The
Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and
5(e)(1)(A)(ii)(I), based on a finding that, in the absence of
sufficient information to permit a reasoned evaluation, the substance
may present an unreasonable risk of injury to human health. To protect
against these risks, the Order requires:
<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 1,000 where there is a potential for inhalation exposure;
<bullet> Manufacture of the PMN substance only by import in a
liquid solution into the United States (i.e., no domestic manufacture);
<bullet> Manufacture, processing, and use of the PMN substance only
if the concentration of the PMN substance does not exceed the
confidential percentage in solution by weight listed in the Order;
<bullet> Manufacture, processing, and use of the PMN substance only
if the proportion of the PMN substance below 1,000 Daltons does not
exceed the confidential percentage by weight listed in the Order;
<bullet> Manufacture, processing, and use of the PMN substance only
if the concentration of the confidential residual feedstock listed in
the Order does not exceed the confidential percentage by weight listed
in the Order;
[[Page 35164]]
<bullet> No processing for use or use of the PMN substance in a
consumer product;
<bullet> Use of the PMN substance only for use as an adhesive
sealant foam for use in construction; 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 irritation, pulmonary effects, skin irritation, skin
sensitization, and specific target organ toxicity testing may be
potentially useful to characterize the health effects of the PMN
substance. Although the Order does not require these tests, the Order's
restrictions remain in effect until the Order is modified or revoked by
EPA based on submission of this or other relevant information.
P-24-105 (40 CFR 721.12275)
Chemical Name: Carbonic acid diaryl ester with alkanediol
(generic).
CASRN or Accession No.: Not available.
Effective Date of TSCA Order: January 7, 2026.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as a raw material of polyurethane. Based on
comparison to analogous chemical substances, EPA predicts toxicity to
aquatic organisms may occur at concentrations that exceed 22 parts per
billion. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and
5(e)(1)(A)(ii)(I), based on a finding that, in the absence of
sufficient information to permit a reasoned evaluation, the substance
may present an unreasonable risk of injury to the environment. To
protect against these risks, the Order requires:
<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 22 parts per billion; 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 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-24-114 (40 CFR 721.12276)
Chemical Name: 1,3-Butanediol, 4,4,4-trifluoro-3-
(trifluoromethyl)-.
CASRN: 21379-33-9.
Effective Date of TSCA Order: December 16, 2025.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as a chemical intermediate. Based on
submitted test data on the PMN substance, EPA has identified concerns
for skin corrosion. Based on comparison to analogous chemical
substances, EPA has also identified concerns for acute (oral) toxicity,
corrosion to the eyes and respiratory tract, and neurological,
systemic, reproductive, and developmental effects. The Order was issued
under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a
finding that, in the absence of sufficient information to permit a
reasoned evaluation, the substance may present an unreasonable risk of
injury to human health. To protect against these risks, the Order
requires:
<bullet> Use of a NIOSH-certified respirator with an APF of at
least 50 where there is a potential for inhalation exposure;
<bullet> Use of personal protective equipment where there is a
potential for dermal exposure;
<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 precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of
inhalation exposure monitoring and acute toxicity, developmental
toxicity, developmental neurotoxicity, eye irritation/corrosion,
neurotoxicity, pulmonary effects, reproductive toxicity, and specific
target organ toxicity testing may be potentially useful to characterize
the health effects of the PMN substance. Although the Order does not
require these tests, the Order's restrictions remain in effect until
the Order is modified or revoked by EPA based on submission of this or
other relevant information.
P-25-106 (40 CFR 721.12277) and P-25-107 (40 CFR 721.12278)
Chemical Names: Sulfonium tris(substitutedcarbomonocycle)
substituted oxatricycloalkyloxycarbonyl dihalo alkane sulfonate
(generic) (P-25-106) and heteromonocyclic alkylsubstituted
carbomonocyclic carbopolycyclic heteromonocyclic dihalo sulfoacetate
(generic) (P-25-107).
CASRNs or Accession Nos.: Not available.
Effective Date of TSCA Order: October 22, 2025.
Basis for TSCA Order: The PMNs state that the generic (non-
confidential) uses will be as components of photoresist. Based on the
physical/chemical properties of the PMN substances (as described in the
New Chemical Program's PBT category at 64 FR 60194; November 1999) and
in the absence of data, the anion and cation of the PMN substances and
the cation photodegradation product of the P-25-106 substance are
potentially persistent, bioaccumulative, and toxic (PBT) chemicals. EPA
estimates that the anions and cations of the PMN substances will
persist in the environment for more than six months and that their
potential to bioaccumulate is unknown. EPA estimates that the cation
photodegradation products of the PMN substances will persist in the
environment for more than six months. For the cation photodegradation
product of the P-24-0106 substance, the potential to bioaccumulate is
unknown. Based on comparison to analogous chemical substances, EPA has
identified concerns for irritation to the skin and respiratory tract,
eye corrosion, and neurological and systemic effects for the cation of
the P-25-106 substance. Based on photoreactivity, EPA has also
identified concerns for skin photosensitization for the P-25-106
substance. Based on comparison to analogous chemical substances, EPA
has
[[Page 35165]]
also identified concerns for skin irritation and eye corrosion for the
P-25-106 substance. Based on submitted test data on the PMN substance,
comparison to analogous chemical substances, and reactivity of the PMN
substance, EPA has also identified concerns for acute toxicity
(inhalation and dermal routes), irritation to the skin and respiratory
tract, eye corrosion, skin sensitization and photosensitization,
genetic toxicity, and neurological and systemic effects for the P-25-
107 substance. Due to insufficient information, EPA was unable to
estimate the environmental hazard of the PMN substances. The Order was
issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I),
based on a finding that, in the absence of sufficient information to
permit a reasoned evaluation, the substances may present an
unreasonable risk of injury to human health and the environment. To
protect against these risks, the Order requires:
<bullet> No manufacture of the PMN substances beyond the time
limits specified in the Order without submittal to EPA of the results
of certain testing described in the Testing section of the Order;
<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 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 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.
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).
B. Executive Order 14192: Unleashing Prosperity Through Deregulation
Executive Order 14192 (90 FR 9065, February 6, 2025) does not apply
because significant new use rules for new chemicals under TSCA section
5 are exempted from review under Executive Order 12866.
C. Paperwork Reduction Act (PRA)
According to the PRA (44 U.S.C. 3501 et seq.), an agency may not
conduct or sponsor, and a person is not required to respond to a
collection of information that requires OMB approval under PRA, unless
it has been approved by OMB and displays a currently valid OMB control
number. The OMB control numbers for EPA's regulations in title 40 of
the CFR, after appearing in the Federal Register, are listed in 40 CFR
part 9, and included on the related collection instrument or form, if
applicable.
The information collection requirements related to SNURs have
already been approved by OMB pursuant to PRA under OMB control number
2070-0038 (EPA ICR No. 1188). 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 23 in FY2023, 7 in FY2024, and 10 in
FY2025, and only a fraction of these submissions were from small
businesses.
In addition, the Agency currently offers relief to qualifying small
businesses by reducing the SNUN submission fee from $37,000 to $6,480.
This lower fee reduces the total reporting and recordkeeping cost of
submitting a SNUN to about $14,967 per SNUN submission for qualifying
small firms. Therefore, the potential economic impacts of complying
with these proposed SNURs are not expected to be significant or
adversely impact a substantial number of small entities. In a SNUR that
published in the Federal Register of June 2, 1997 (62 FR 29684 (FRL-
5597-1)), the Agency presented its general determination that SNURs are
not expected to have a significant economic impact on a substantial
number of small entities, which was provided to the Chief Counsel for
Advocacy of the Small Business Administration.
E. Unfunded Mandates Reform Act (UMRA)
This action does not contain an unfunded mandate of $100 million or
more (in 1995 dollars) in any one year as described in UMRA, 2 U.S.C.
1531-1538, and does not significantly or
[[Page 35166]]
uniquely affect small governments. Based on EPA's experience with
proposing and finalizing SNURs, State, local, and Tribal governments
have not been impacted by SNURs, and EPA does not have any reasons to
believe that any State, local, or Tribal government will be impacted by
these SNURs. In addition, the estimated costs of this action to the
private sector do not exceed $183 million or more in any one year (the
1995 dollars are adjusted to 2023 dollars for inflation using the GDP
implicit price deflator). The estimated costs for this action are
discussed in Unit I.D.
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).
List of Subjects in 40 CFR Part 721
Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.
Dated: June 4, 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. 721.12260 through 721.12278 to subpart E to read as
follows:
* * * * *
Sec.
721.12260 6-Octen-1-ol, 3,7-dimethyl-, homopolymer, monoacetate.
721.12261 Alkanedioic acid, di branched alkyl esters (generic).
721.12262 Alkanedioic acid, di C11-14 isoalkyl esters (generic).
721.12263 Siloxanes and silicones, di-Me, [alkylpiperazinium-
hydroxyalkoxy]alkyl group-terminated, arylsulfonates (salts)
(generic).
721.12264 Siloxanes and silicones, di-Me, [alkylpiperazinium-
hydroxyalkoxy]alkyl group- and (hydroxyalkoxy)alkyl group-
terminated, ethers with polyethylene glycol alkyl ethers,
arylsulfonates (salts) (generic).
721.12265 Soybean oil, polymer with diethylene glycol- and glycerol-
and tetraethylene glycol- and triethylene glycol-depolymd.
poly(ethylene terephthalate) waste plastics, 3-hydroxy-2-
(hydroxymethyl)-2-methylpropanoic acid and phthalic anhydride.
721.12266 Benzoicacid,2-([1,1'-biphenyl]-4-ylcarbonyl)-,2-
ethylhexylester.
721.12267 Ethyl modified lactam (generic).
721.12268 Substituted carbopolycyclic dicarboxylic acid dialkyl
ester, polymer with alkanediol, carbopolycyclic bis(substituted
carbopolycycle)bis[alkanol] and carbopolycyclic bis(substituted
carbomonocycle)bis[alkanol] (generic).
721.12269 Polymeric salt of propenoic acid, acrylamido-methylpropane
sulfonic acid sodium salt, hydroxyethyl methacrylate, methyl
methacrylate, propenoic acid, methyl-, phosphinicobis(oxy-
ethanediyl) ester, sodium metabisulfite (generic).
721.12270 2-Propanamine, N,N'-(oxydi-2,1-ethanediyl)bis[N-methyl-.
721.12271 Polyalkyl substituted amine, hydrolysis products with
alkenyltrialkoxymetalloid and silica (generic).
721.12272 Alkanol, alkoxyalkylimino, salt (generic).
721.12273 Alkanol, nitrilo, salt (generic).
721.12274 Aryl-dicarboxylic acid, polymer with alkanedioic acid,
2,2'-oxypoly[alkanol], polymethylenepolyphenylene isocyanate and
alkane diol (generic).
721.12275 Carbonic acid diaryl ester with alkanediol (generic).
721.12276 1,3-Butanediol, 4,4,4-trifluoro-3-(trifluoromethyl)-.
721.12277 Sulfonium tris(substitutedcarbomonocycle) substituted
oxatricycloalkyloxycarbonyl dihalo alkane sulfonate (generic).
721.12278 Heteromonocyclic alkylsubstituted carbomonocyclic
carbopolycyclic heteromonocyclic dihalo sulfoacetate (generic).
* * * * *
Sec. 721.12260 6-Octen-1-ol, 3,7-dimethyl-, homopolymer, monoacetate.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 6-octen-1-ol, 3,7-
dimethyl-, homopolymer, monoacetate (PMN P-20-174; CASRN 2417284-25-2)
is subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), and (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.
(ii) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the substance in
any manner that results in worker inhalation exposure to the substance.
(iii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=669.
[[Page 35167]]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (f) through (i), and (k) are applicable to
manufacturers, importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12261 Alkanedioic acid, di branched alkyl esters (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
alkanedioic acid, di branched alkyl esters (PMN P-21-104; Accession No.
303674) is subject to reporting under this section for the significant
new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in 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), and (g)(1) and (5). For purposes of Sec.
721.72(g)(1), this substance may cause: skin irritation, eye
irritation, and specific target organ toxicity. Alternative hazard and
warning statements that meet the criteria of the Globally Harmonized
System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in 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 to the substance.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in 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. 721.12262 Alkanedioic acid, di C11-14 isoalkyl esters (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
alkanedioic acid, di C11-14 isoalkyl esters (PMN P-21-105; Accession
No. 303663) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in 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), and (g)(1) and (5). For purposes of Sec.
721.72(g)(1), this substance may cause: skin irritation, eye
irritation, and specific target organ toxicity. Alternative hazard and
warning statements that meet the criteria of the Globally Harmonized
System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in 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 to the substance.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in 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. 721.12263 Siloxanes and silicones, di-Me, [alkylpiperazinium-
hydroxyalkoxy]alkyl group-terminated, arylsulfonates (salts) (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
siloxanes and silicones, di-Me, [alkylpiperazinium-hydroxyalkoxy]alkyl
group-terminated, arylsulfonates (salts) (PMN P-21-166) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section. The requirements of this section do
not apply to quantities of the substance when contained in an article
as defined at 40 CFR 720.3(c).
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in 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: 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 other than in the form of a
liquid solution. It is a significant new use to manufacture, process,
or use the substance in any manner that results in inhalation exposure
to the substance.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=9. For purposes of Sec.
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.
[[Page 35168]]
Sec. 721.12264 Siloxanes and silicones, di-Me, [alkylpiperazinium-
hydroxyalkoxy]alkyl group- and (hydroxyalkoxy)alkyl group-terminated,
ethers with polyethylene glycol alkyl ethers, arylsulfonates (salts)
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
siloxanes and silicones, di-Me, [alkylpiperazinium-hydroxyalkoxy]alkyl
group- and (hydroxyalkoxy)alkyl group-terminated, ethers with
polyethylene glycol alkyl ethers, arylsulfonates (salts) (PMN P-21-167)
is subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section. The requirements of this
section do not apply to quantities of the substance when contained in
an article as defined at 40 CFR 720.3(c).
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in 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: 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 other than in the form of a
liquid solution. It is a significant new use to manufacture, process,
or use the substance in any manner that results in inhalation exposure
to the substance.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=0.7. For purposes of Sec.
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. 721.12265 Soybean oil, polymer with diethylene glycol- and
glycerol- and tetraethylene glycol- and triethylene glycol-depolymd.
poly(ethylene terephthalate) waste plastics, 3-hydroxy-2-
(hydroxymethyl)-2-methylpropanoic acid and phthalic anhydride.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as soybean oil,
polymer with diethylene glycol- and glycerol- and tetraethylene glycol-
and triethylene glycol-depolymd. poly(ethylene terephthalate) waste
plastics, 3-hydroxy-2-(hydroxymethyl)-2-methylpropanoic acid and
phthalic anhydride (PMN P-23-78; CASRN 2803562-50-5) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section. The requirements of this section do
not apply to quantities of the substance after they have been
completely reacted or cured (i.e., the substance has been reacted or
cured to the extent that no release of the substance can be detected).
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (3) through (6), and (c). When determining which persons
are reasonably likely to be exposed as required for Sec. 721.63(a)(1)
and (4), engineering control measures (e.g., enclosure or confinement
of the operation, general and local ventilation) or administrative
control measures (e.g., workplace policies and procedures) shall be
considered and implemented to prevent exposure, where feasible. For
purposes of Sec. 721.63(a)(5), respirators must provide a National
Institute for Occupational Safety and Health (NIOSH) assigned
protection factor (APF) of at least 1,000.
(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, 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 unless all of the following are true: (1) the substance is
used in the B side (polyol) of a spray polyurethane foam formulation,
(2) the concentration of the substance on the B side does not exceed
the confidential percentage by weight listed in the Order, and (3) the
substance is used in an application process designed to result in
instant and complete reaction of the B side containing the substance
with the A side (isocyanate) such that there is no unreacted polyol
present in any overspray.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=58.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in 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. 721.12266 Benzoicacid,2-([1,1'-biphenyl]-4-ylcarbonyl)-,2-
ethylhexylester.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as benzoicacid,2-
([1,1'-biphenyl]-4-ylcarbonyl)-,2-ethylhexylester (PMN P-23-138; CASRN
75005-95-7) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section. The
requirements of this section do not apply to quantities of the
substance after they have been completely reacted or cured (i.e., the
substance has been reacted or cured to the extent that no release of
the substance can be detected).
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in 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)
[[Page 35169]]
through (d), (f), (g)(1), g(3)(iii), and (g)(5). For purposes of Sec.
721.72(g)(1), this substance may cause: skin sensitization. Alternative
hazard and warning statements that meet the criteria of the Globally
Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o). It is a significant new use to use the
substance at a concentration greater than 5% by weight in formulation.
(iv) Release to water. Requirements as specified in 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. 721.12267 Ethyl modified lactam (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as ethyl
modified lactam (PMN P-23-183) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section. The requirements of this section do not apply to
quantities of the substance after they have been completely reacted or
cured (i.e., the substance has been reacted or cured to the extent that
no release of the substance can be detected).
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in 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), and (g)(1) and (5). For purposes of Sec.
721.72(g)(1), this substance may cause: acute toxicity, serious eye
damage, and specific target organ toxicity. Alternative hazard and
warning statements that meet the criteria of the Globally Harmonized
System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o). It is a significant new use to use the
substance in spray applications unless in an enclosed process.
(iv) Disposal. Requirements as specified in Sec. 721.85(a)(1),
(b)(1), and (c)(1).
(v) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=3143.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in 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. 721.12268 Substituted carbopolycyclic dicarboxylic acid dialkyl
ester, polymer with alkanediol, carbopolycyclic bis(substituted
carbopolycycle)bis[alkanol] and carbopolycyclic bis(substituted
carbomonocycle)bis[alkanol] (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
substituted carbopolycyclic dicarboxylic acid dialkyl ester, polymer
with alkanediol, carbopolycyclic bis(substituted
carbopolycycle)bis[alkanol] and carbopolycyclic bis(substituted
carbomonocycle)bis[alkanol] (PMN P-23-193) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section. The requirements of this section do not apply
to quantities of the substance after they have been incorporated into
an article as defined at 40 CFR 720.3(c).
(2) The significant new uses are:
(i) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), and (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.
(ii) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture the substance in any manner unless
at least one of the following is true: (1) the substance has a mean
particle size equal to or greater than 2.5 millimeters or (2) where the
percentage of particles of the substance with a diameter less than 1.4
millimeters is less than or equal to 0.01 percent by weight.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c) and (f) through (i) are applicable to
manufacturers, importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12269 Polymeric salt of propenoic acid, acrylamido-
methylpropane sulfonic acid sodium salt, hydroxyethyl methacrylate,
methyl methacrylate, propenoic acid, methyl-, phosphinicobis(oxy-
ethanediyl) ester, sodium metabisulfite (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
polymeric salt of propenoic acid, acrylamido-methylpropane sulfonic
acid sodium salt, hydroxyethyl methacrylate, methyl methacrylate,
propenoic acid, methyl-, phosphinicobis(oxy-ethanediyl) ester, sodium
metabisulfite (PMN P-24-6;) is subject to reporting under this section
for the significant new uses described in paragraph (a)(2) of this
section.
(2) The significant new uses are:
(i) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), and (g)(3)(iii) and(5). Alternative hazard
and warning statements that meet the criteria of the Globally
Harmonized System and OSHA Hazard Communication Standard may be used.
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=316.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (f) through (h), and (k) are applicable to
manufacturers, importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
[[Page 35170]]
Sec. 721.12270 2-Propanamine, N,N'-(oxydi-2,1-ethanediyl)bis[N-
methyl-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 2-propanamine,
N,N'-(oxydi-2,1-ethanediyl)bis[N-methyl- (PMN P-24-16; CASRN 2484716-
03-0) is subject to reporting under this section for the significant
new uses described in paragraph (a)(2) of this section. The
requirements of this section do not apply to quantities of the
substance after they have been completely reacted or cured (i.e., the
substance has been reacted or cured to the extent that no release of
the substance can be detected).
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (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.
(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 corrosion, serious eye damage, reproductive toxicity,
and specific target organ toxicity. Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System and
OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o). It is a significant new use to process
or use the substance other than as a catalyst in two-part polyurethane
spray foam insulation applications. It is a significant new use to
process or use the substance at a concentration greater than 3 percent
by weight in formulation.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=89.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in 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. 721.12271 Polyalkyl substituted amine, hydrolysis products with
alkenyltrialkoxymetalloid and silica (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
polyalkyl substituted amine, hydrolysis products with
alkenyltrialkoxymetalloid and silica (PMN P-24-20) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section. The requirements of this section do
not apply to quantities of the substance after they have been
completely reacted or cured (i.e., the substance has been reacted or
cured to the extent that no release of the substance can be detected).
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(4) through (6), and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(4),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible. For purposes of
Sec. 721.63(a)(5), respirators must provide a National Institute for
Occupational Safety and Health (NIOSH) assigned protection factor (APF)
of at least 1,000.
(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(o). It is a significant new use to
manufacture the substance beyond the confidential annual production
volume listed in the Order.
(iv) Release to water. Requirements as specified in 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. 721.12272 Alkanol, alkoxyalkylimino, salt (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
alkanol, alkoxyalkylimino, salt (PMN P-24-46) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in 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: serious eye
damage and specific target organ toxicity. Alternative hazard and
warning statements that meet the criteria of the Globally Harmonized
System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in 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 to the substance. It is a significant new use to
manufacture, process, or use the substance other than in liquid
solution.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N=101 in aggregate of P-24-46
and P-24-47.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i), and (k) are
[[Page 35171]]
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. 721.12273 Alkanol, nitrilo, salt (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
alkanol, nitrilo, salt (PMN P-24-47) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in 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: serious eye
damage and specific target organ toxicity. Alternative hazard and
warning statements that meet the criteria of the Globally Harmonized
System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in 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 to the substance. It is a significant new use to
manufacture, process, or use the substance other than in liquid
solution.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N=101 in aggregate of P-24-46
and P-24-47.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in 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. 721.12274 Aryl-dicarboxylic acid, polymer with alkanedioic acid,
2,2'-oxypoly[alkanol], polymethylenepolyphenylene isocyanate and alkane
diol (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as aryl-
dicarboxylic acid, polymer with alkanedioic acid, 2,2'-
oxypoly[alkanol], polymethylenepolyphenylene isocyanate and alkane diol
(PMN P-24-70) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section. The
requirements of this section do not apply to quantities of the
substance after they have been completely reacted or cured (i.e., the
substance has been reacted or cured to the extent that no release of
the substance can be detected).
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (3) through (6), and (c). When determining which persons
are reasonably likely to be exposed as required for Sec. 721.63(a)(1)
and (4), engineering control measures (e.g., enclosure or confinement
of the operation, general and local ventilation) or administrative
control measures (e.g., workplace policies and procedures) shall be
considered and implemented to prevent exposure, where feasible. For
purposes of Sec. 721.63(a)(5), respirators must provide a National
Institute for Occupational Safety and Health (NIOSH) assigned
protection factor (APF) of at least 1,000.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), and (g)(1) and (5). For purposes of Sec.
721.72(g)(1), this substance may cause: acute toxicity, eye irritation,
respiratory sensitization, skin irritation, skin sensitization, and
specific target organ toxicity. Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System and
OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o). It is a significant new use to
manufacture the substance other than by import in a liquid solution
into the United States (i.e., no domestic manufacture). It is a
significant new use to manufacture, process, or use the substance if
the concentration of the substance in solution exceeds the confidential
percentage by weight listed in the Order. It is a significant new use
to manufacture, process, or use the substance if the proportion of the
substance below 1,000 Daltons exceeds the confidential percentage by
weight listed in the Order. It is a significant new use to manufacture,
process, or use the substance if the concentration of the confidential
residual feedstock exceeds the confidential percentage by weight listed
in the Order. It is a significant new use to use the substance other
than as an adhesive sealant foam for use in construction.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in 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. 721.12275 Carbonic acid diaryl ester with alkanediol (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
carbonic acid diaryl ester with alkanediol (PMN P-24-105) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), and (g)(3)(iii) and (5). Alternative hazard
and warning statements that meet the criteria of the Globally
Harmonized System and OSHA Hazard Communication Standard may be used.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o).
(iii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=22.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (f) through (i), and (k) are applicable to
manufacturers, importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.12276 1,3-Butanediol, 4,4,4-trifluoro-3-(trifluoromethyl)-.
(a) Chemical substance and significant new uses subject to
reporting.
[[Page 35172]]
(1) The chemical substance identified as 1,3-butanediol, 4,4,4-
trifluoro-3-(trifluoromethyl)- (PMN P-24-114; CASRN 21379-33-9) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (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.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), and (g)(1) and (5). For purposes of Sec.
721.72(g)(1), this substance may cause: acute toxicity, skin corrosion,
eye corrosion, reproductive toxicity, and specific target organ
toxicity. Alternative hazard and warning statements that meet the
criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in 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. 721.12277 Sulfonium tris(substitutedcarbomonocycle) substituted
oxatricycloalkyloxycarbonyl dihalo alkane sulfonate (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
sulfonium tris(substitutedcarbomonocycle) substituted
oxatricycloalkyloxycarbonyl dihalo alkane sulfonate (PMN P-25-106) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section. The requirements of this
section do not apply to quantities of the substance after they have
been completely reacted or adhered (during photolithographic processes)
onto a semiconductor wafer surface or similar manufactured article used
in the production of semiconductor technologies.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in 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 (v),
(g)(3)(i) and (ii), and (g)(5). For purposes of Sec. 721.72(e), the
concentration is set at 1.0%. 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 18 months.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in 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. 721.12278 Heteromonocyclic alkylsubstituted carbomonocyclic
carbopolycyclic heteromonocyclic dihalo sulfoacetate (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
heteromonocyclic alkylsubstituted carbomonocyclic carbopolycyclic
heteromonocyclic dihalo sulfoacetate (PMN P-25-107) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section. The requirements of this section do
not apply to quantities of the substance after they have been
completely reacted or adhered (during photolithographic processes) onto
a semiconductor wafer surface or similar manufactured article used in
the production of semiconductor technologies.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in 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 (v),
(g)(3)(i) and (ii), and (g)(5). For purposes of Sec. 721.72(e), the
concentration is set at 1.0%. 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 18 months.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
[[Page 35173]]
(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.
[FR Doc. 2026-11593 Filed 6-9-26; 8:45 am]
BILLING CODE 6560-50-P
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</html>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.