Rule2026-21051
Significant New Use Rules on Certain Chemical Substances (26-1)
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
October 15, 2026
Effective
December 14, 2026
Issuing agencies
Environmental Protection Agency
Abstract
EPA is issuing significant new use rules (SNURs) under the Toxic Substances Control Act (TSCA) for certain chemical substances that were the subject of premanufacture notices (PMNs) and are also subject to an Order issued by EPA pursuant to TSCA. The SNURs require persons to notify EPA at least 90 days before commencing the manufacture (defined by statute to include import) or processing of any of these chemical substances for an activity that is designated as a significant new use in the SNUR. The required notification initiates EPA's evaluation of the conditions of that use for that chemical substance. In addition, the manufacture or processing for the significant new use may not commence until EPA has conducted a review of the required notification; made an appropriate determination regarding that notification; and taken such actions as required by that determination.
Full Text
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<title>Federal Register, Volume 91 Issue 198 (Thursday, October 15, 2026)</title>
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[Federal Register Volume 91, Number 198 (Thursday, October 15, 2026)]
[Rules and Regulations]
[Pages 65461-65471]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-21051]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[EPA-HQ-OPPT-2026-0499; FRL-13317-02-OCSPP]
RIN 2070-AB27
Significant New Use Rules on Certain Chemical Substances (26-1)
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: EPA is issuing significant new use rules (SNURs) under the
Toxic Substances Control Act (TSCA) for
[[Page 65462]]
certain chemical substances that were the subject of premanufacture
notices (PMNs) and are also subject to an Order issued by EPA pursuant
to TSCA. The SNURs require persons to notify EPA at least 90 days
before commencing the manufacture (defined by statute to include
import) or processing of any of these chemical substances for an
activity that is designated as a significant new use in the SNUR. The
required notification initiates EPA's evaluation of the conditions of
that use for that chemical substance. In addition, the manufacture or
processing for the significant new use may not commence until EPA has
conducted a review of the required notification; made an appropriate
determination regarding that notification; and taken such actions as
required by that determination.
DATES: This rule is effective on December 14, 2026. For purposes of
judicial review, this rule shall be promulgated at 1 p.m. (EST) on
October 29, 2026.
ADDRESSES: The docket for this action, identified under docket
identification (ID) number EPA-HQ-OPPT-2026-0499, is available online
at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or in person at the Office of Pollution
Prevention and Toxics Docket (OPPT Docket) in the Environmental
Protection Agency Docket Center (EPA/DC). Please review the visitor
instructions and additional information about the docket 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,
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#dbbcbaa9b9b2b5f5b1b4a9bfbab59bbeabbaf5bcb4ad"><span class="__cf_email__" data-cfemail="690e081b0b00074703061b0d0807290c1908470e061f">[email protected]</span></a>.
For general information on SNURs: Iliriana Mushkolaj, New Chemicals
Division, Office of Pollution Prevention and Toxics, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; telephone number: (202) 564-6877; email address:
<a href="/cdn-cgi/l/email-protection#7b160e08131014171a115512171209121a151a3b1e0b1a551c140d"><span class="__cf_email__" data-cfemail="107d6563787b7f7c717a3e797c796279717e71507560713e777f66">[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#a8fcfbebe985e0c7dcc4c1c6cde8cdd8c986cfc7de"><span class="__cf_email__" data-cfemail="6c383f2f2d41240318000502092c091c0d420b031a">[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).
B. What action is the Agency taking?
EPA is finalizing SNURs under TSCA section 5(a)(2) for the chemical
substances identified in this document. These chemical substances were
the subject of PMNs and are also subject to an Order issued by EPA
pursuant to TSCA section 5(e)(1)(A), as required by the determinations
made under TSCA section 5(a)(3)(B). The 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). The SNURs
require persons who intend to manufacture or process any of these
chemical substances for an activity that is designated as a significant
new use in the SNURs to notify EPA at least 90 days before commencing
that activity.
Previously, EPA proposed SNURs for these chemical substances in the
Federal Register of June 10, 2026 (91 FR 35156 (FRL-13317-01-OCSPP)).
The docket includes information considered by the Agency in developing
the proposed and final rules, including public comments and EPA's
responses to the comments received as discussed in Unit II.D.
C. Does this action apply to me?
1. General Applicability
This action applies to you if you manufacture, process, or use the
chemical substances identified in this document. 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 part 707, subpart B. Importers of chemical substances in bulk form,
as part of a mixture, or as part of an article (if required by rule)
must certify that the shipment of the chemical substance complies with
all applicable rules and orders under TSCA, including regulations
issued under TSCA sections 5, 6, 7 and Title IV.
Pursuant to 40 CFR 721.20, any persons who export or intend to
export a chemical substance identified in this document are subject to
the export notification provisions of TSCA section 12(b) (15 U.S.C.
2611(b)) and must comply with the export notification requirements in
40 CFR part 707, subpart D.
D. What are the incremental economic impacts of this action?
EPA has evaluated the potential costs of establishing SNUN
reporting requirements for potential manufacturers and processors of
the chemical substances identified in this document. This analysis,
which is available in the docket, is briefly summarized here.
1. Estimated Costs for SNUN Submissions
A SNUR requires that any person who intends to engage in such
activity in the future must first notify EPA by submitting a SNUN. If a
SNUN is submitted, costs are an estimated $45,000 per SNUN submission
for large business submitters and $14,500 for small business
submitters. These estimates include the cost to prepare and submit the
SNUN (including registration for EPA's Central Data Exchange (CDX)),
and the payment of a user fee. Businesses that submit a SNUN would be
subject to either a $37,000 user fee required by 40 CFR
700.45(c)(2)(ii) and (d), or, if they are a small business as defined
at 13 CFR 121.201, a reduced user fee of $6,480 (40 CFR
700.45(c)(1)(ii) and (d)). These estimates reflect the costs and fees
as they are known at the time of this rulemaking.
[[Page 65463]]
2. Estimated Costs for Export Notifications
EPA has also evaluated the potential costs associated with the pre-
existing 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.
II. Background
A. General Information About SNURs
Unit II. of the proposed rule provides general information about
SNURs, and additional information about EPA's new chemical program is
available 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>.
B. Applicability of the Significant New Use Designation
To establish a significant new use, EPA must determine that the use
is not ongoing. As discussed in Unit II.E. of the proposed rule, EPA
concluded that the proposed significant new uses were not ongoing. EPA
also stated that if EPA subsequently determined that such a use was
ongoing as of the date of publication of the proposed rule and did not
cease prior to issuance of the final rule, EPA would not designate that
use as a significant new use in the final rule. EPA has no information
to suggest that any of the significant new uses identified in this rule
meet this criterion.
As discussed in the Federal Register of April 24, 1990 (55 FR 17376
(FRL-3658-5)), EPA believes that the intent of TSCA section 5(a)(1)(B)
is best served by designating a use as a significant new use as of the
date of publication of the proposed rule rather than as of the
effective date of the final rule. The objective of EPA's approach is to
ensure that a person cannot impede finalization of a SNUR by initiating
a significant new use after publication of the proposed rule but before
the effective date of the final rule. Uses arising after the
publication of the proposed rule are distinguished from uses that are
identified in the final rule as having been ongoing on the date of
publication of the proposed rule. The former would be new uses, the
latter ongoing uses, except that uses that are identified as ongoing as
of the publication of the proposed rule would not be considered ongoing
uses if they have ceased by the date of issuance of a final rule.
In the unlikely event that before a final rule becomes effective a
person begins commercial manufacturing (including importing) or
processing of the chemical substances for a use that is designated as a
significant new use in that final rule, such a person 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 wait until all TSCA
prerequisites for the commencement of manufacture or processing have
been satisfied.
Issuance of a SNUR for a chemical substance does not signify that
the chemical substance is listed on the TSCA Chemical Substance
Inventory (TSCA Inventory). Guidance on how to determine if a chemical
substance is on the TSCA Inventory is available on the internet at
<a href="https://www.epa.gov/tsca-inventory">https://www.epa.gov/tsca-inventory</a>.
C. 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. of the proposed rule.
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. of the
proposed rule may not be the only means of providing information to
evaluate the chemical substance associated with the significant new
uses. However, submitting a SNUN without any test data may increase the
likelihood that EPA will take action under TSCA sections 5(e) or 5(f).
EPA recommends that potential SNUN submitters contact EPA early enough
so that they will be able to conduct the appropriate tests.
SNUN submitters should be aware that EPA will be better able to
evaluate SNUNs which provide detailed information about human exposure
and environmental release that may result from the significant new use
of the chemical substances.
D. Public Comments on Proposed Rule and EPA Responses
EPA received public comments on the proposed SNURs and prepared a
Response to Comment document that provides the Agency responses. The
comments and the Response to Comment document are available in the
docket; ID number EPA-HQ-OPPT-2026-0499. EPA is finalizing these SNURs
as proposed.
[[Page 65464]]
III. Chemical Substances Subject to These SNURs
A. What is the designated cutoff date for ongoing uses?
EPA designates the date of publication of the proposed rule as the
cutoff date for determining whether the new use is ongoing, i.e., June
10, 2026 (91 FR 35156 (FRL-13317-01-OCSPP)). This designation is
explained in more detail in Unit II.B.
B. What information was provided for each chemical substance?
In Unit III.C. of the proposed rule, EPA provided the following
information for each chemical substance subject to these SNURs:
<bullet> PMN number (the 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 TSCA Order).
<bullet> Potentially useful information.
The regulatory text section of this document specifies the chemical
substances and activities designated as significant new uses. Certain
new uses, including production volume limits and other uses designated,
may be claimed as CBI, as discussed in more detail in Unit II.C. of the
proposed rule.
In addition, as discussed in Unit III.B. of the proposed rule,
these 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. As such, the 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).
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 establishes 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 a significant new use rule for a new chemical under TSCA
section 5 is exempt 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.
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 7 in Federal fiscal year (FY) 2020, 9 in
FY2021, 9 in FY2022, 23 in FY2023, and 7 in FY2024, and only a fraction
of these submissions were from small businesses.
In addition, the Agency currently offers relief to qualifying small
businesses by reducing the SNUN submission fee from $37,000 to $6,480.
This lower fee reduces the total reporting and recordkeeping cost of
submitting a SNUN to about $14,500 per SNUN submission for qualifying
small firms. Therefore, the potential economic impacts of complying
with these proposed SNURs are not expected to be significant or
adversely impact a substantial number of small entities. In a SNUR that
published in the Federal Register of June 2, 1997 (62 FR 29684 (FRL-
5597-1)), the Agency presented its general determination that SNURs are
not expected to have a significant economic impact on a substantial
number of small entities, which was provided to the Chief Counsel for
Advocacy of the Small Business Administration.
E. Unfunded Mandates Reform Act (UMRA)
This action does not contain an unfunded mandate of $100 million or
more (in 1995 dollars) in any one year as described in UMRA, 2 U.S.C.
1531-1538, and does not significantly or uniquely affect small
governments. Based on EPA's experience with proposing and finalizing
SNURs, State, local, and Tribal governments have not been impacted by
SNURs, and EPA does not have any reasons to believe that any State,
local, or Tribal government will be impacted by these SNURs. In
addition, the estimated costs of this action to the private sector do
not exceed $183 million or more in any one year (the 1995 dollars are
adjusted to 2023 dollars for inflation using the GDP implicit price
deflator). The estimated costs for this action are discussed in Unit
I.D.
F. Executive Order 13132: Federalism
This action will not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999), because it is not
expected to have a substantial direct effect on States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various
[[Page 65465]]
levels of government. Accordingly, the requirements of Executive Order
13132 do not apply to this action.
G. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments
This action will not have Tribal implications as specified in
Executive Order 13175 (65 FR 67249, November 9, 2000), because it is
not expected to have substantial direct effects on Indian Tribes,
significantly or uniquely affect the communities of Indian Tribal
governments and does not involve or impose any requirements that affect
Indian Tribes. Accordingly, the requirements of Executive Order 13175
do not apply to this action.
H. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks
This action is not subject to Executive Order 13045 (62 FR 19885,
April 23, 1997), because it does not concern an environmental health or
safety risk. Since this action does not concern a human health risk,
EPA's 2026 Policy on Children's Health also does not apply. Although
the establishment of these SNURs does 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).
K. Congressional Review Act (CRA)
This action is subject to the CRA (5 U.S.C. 801 et seq.), and EPA
will submit a rule report to each House of the Congress and to the
Comptroller General of the United States. This action is not a ``major
rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 721
Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.
Dated: October 8, 2026.
Mary Elissa Reaves,
Director, Office of Pollution Prevention and Toxics.
For the reasons stated in the preamble, 40 CFR chapter I is amended
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 Benzoic acid,
2[hyphen]([1,1'[hyphen]biphenyl][hyphen]4[hyphen]ylcarbonyl)[hyphen],
2[hyphen]ethylhexyl ester.
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.
(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.
[[Page 65466]]
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.
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
[[Page 65467]]
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), (a)(3) through (6), and (c). When determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1) and (4), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible. For purposes of Sec. 721.63(a)(5), respirators must
provide a National Institute for Occupational Safety and Health (NIOSH)
assigned protection factor (APF) of at least 1,000.
(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 Benzoic acid, 2-([1,1'-biphenyl]-4-ylcarbonyl)-, 2-
ethylhexyl ester.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as benzoic acid, 2-
([1,1'-biphenyl]-4-ylcarbonyl)-, 2-ethylhexyl ester (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) 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
[[Page 65468]]
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; Accession No. 303721) 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 (g)(5). Alternative
hazard and warning statements that meet the criteria of the Globally
Harmonized System and OSHA Hazard Communication Standard may be used.
(ii) 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.
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
[[Page 65469]]
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), (a)(3) through (6), and (c). When determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1) and (4), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible. For purposes of Sec. 721.63(a)(5), respirators must
provide a National Institute for Occupational Safety and Health (NIOSH)
assigned protection factor (APF) of at least 50.
(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(a)(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 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 65470]]
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), (a)(3) through (6), and (c). When determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1) and (4), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible. For purposes of Sec. 721.63(a)(5), respirators must
provide a National Institute for Occupational Safety and Health (NIOSH)
assigned protection factor (APF) of at least 1,000.
(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 (g)(5). Alternative
hazard and warning statements that meet the criteria of the Globally
Harmonized System and OSHA Hazard Communication Standard may be used.
(ii) Industrial, commercial, and consumer activities. 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. (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.
[[Page 65471]]
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(3) through (6), and (c). When determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1) and (4), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible. For purposes of Sec. 721.63(a)(5), respirators must
provide a National Institute for Occupational Safety and Health (NIOSH)
assigned protection factor (APF) of at least 50.
(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 (g)(2)(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 (g)(2)(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.
[FR Doc. 2026-21051 Filed 10-14-26; 8:45 am]
BILLING CODE 6560-50-P
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</html>Indexed from Federal Register on October 15, 2026.
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