BILLING CODE 6560-50-P
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[EPA-HQ-OPPT-2023-0328; FRL-11825-01-OCSPP]
RIN 2070-AB27
Significant New Use Rules on Certain Chemical Substances (23-3.5e)
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
SUMMARY: EPA is proposing significant new use rules (SNURs) under the Toxic Substances
Control Act (TSCA) for chemical substances that were the subject of premanufacture notices
(PMNs) and are also subject to a TSCA Order. A SNUR requires persons who intend to
manufacture (defined by statute to include import) or process a particular chemical substance for
an activity that is identified as a significant new use in the SNUR to notify EPA at least 90 days
before commencing that activity. The required notification initiates EPA’s evaluation of the
conditions of use identified in the notification to EPA. 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 [INSERT DATE 30 DAYS AFTER DATE
OF PUBLICATION IN THE FEDERAL REGISTER].
ADDRESSES: Submit your comments, identified by docket identification (ID) number EPAHQ-OPPT- 2023-0328, online at https://www.regulations.gov. Follow the online instructions for
submitting comments. Do not submit electronically any information you consider to be
Confidential Business Information (CBI) or other information whose disclosure is restricted by
statute. Additional instructions on commenting and visiting the docket, along with more
information about dockets generally, is available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: For technical information: 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: wysong.william@epa.gov.
For general information: The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave.,
Rochester, NY 14620; telephone number: (202) 554-1404; email address: TSCAHotline@epa.gov.
SUPPLEMENTARY INFORMATION:
I. Executive Summary
A. What is the Agency's authority for taking this action?
TSCA section 5(a)(2) (15 U.S.C. 2604(a)(2)) authorizes EPA to determine that a use of a
chemical substance is a “significant new use.” EPA must make this determination by rule after
considering all relevant factors, including the factors in TSCA section 5(a)(2) (see also the
discussion in Unit II.).
B. What action is the Agency taking?
EPA is proposing SNURs for chemical substances that were the subject of PMNs as
discussed in Unit III. These SNURs, if finalized as proposed, would require persons who intend
to manufacture or process any of these chemical substances for an activity that is designated as a
significant new use to notify EPA at least 90 days before commencing that activity.
C. Does this action apply to me?
1. General applicability.
This action applies to you if you manufacture, process, or use the chemical substances
contained in this proposed rule. The following list of North American Industrial Classification
System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help
readers determine whether this document applies to them. Potentially affected entities may
include:

• Manufacturers or processors of one or more subject chemical substances (NAICS)
codes 325 and 324110, e.g., chemical manufacturing and petroleum refineries.
2. Applicability to importers and exporters.
This action may also apply to certain entities through pre-existing import certification and
export notification rules under TSCA (https://www.epa.gov/tsca-import-export-requirements).
Chemical importers are subject to the import provisions in TSCA section 13 (15 U.S.C.
2612), the requirements promulgated at 19 CFR 12.118 through 12.127 (see also 19 CFR
127.28), and the EPA policy in support of import certification at 40 CFR part 707, subpart B.
Chemical importers 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 TSCA 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 [INSERT DATE 30 DAYS
AFTER DATE OF PUBLICATION IN THE FEDERAL REGISTER] 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 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 $45,000 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)) per fiscal year 2022. The costs of submission for SNUNs will not be incurred by any
company unless a company decides to pursue a significant new use as defined in these SNURs.
Additionally, these estimates reflect the costs and fees as they are known at the time of this
rulemaking.
2. Estimated costs for export notifications.
EPA has also evaluated the potential costs associated with the export notification
requirements under TSCA section 12(b) and the implementing regulations at 40 CFR part 707,
subpart D. For persons exporting a substance that is the subject of a SNUR, a one-time notice to
EPA must be provided for the first export or intended export to a particular country. The total
costs of export notification will vary by chemical, depending on the number of required
notifications (i.e., the number of countries to which the chemical is exported). While EPA is
unable to make any estimate of the likely number of export notifications for the chemical
substances covered by these SNURs, as stated in the accompanying economic analysis, the
estimated cost of the export notification requirement on a per unit basis is approximately $106.
E. What should I consider as I prepare my comments for EPA?
1. Submitting CBI.
Do not submit CBI to EPA through email or https://www.regulations.gov. If you wish to
include CBI in your comment, please follow the applicable instructions at https://www.epa.gov/
dockets/commenting-epa-dockets#rules and clearly mark the information that you claim to be
CBI. Information so marked will not be disclosed except in accordance with procedures set forth
in 40 CFR parts 2 and 703.
2. Tips for preparing your comments.
When preparing and submitting your comments, see the commenting tips at
https://www.epa.gov/dockets/commenting-epa-dockets.

II. Background
This unit provides general information about SNURs. For additional information about
EPA’s new chemical program go to https://www.epa.gov/reviewing-new-chemicals-under-toxicsubstances-control-act-tsca.
A. Significant New Use Determination Factors
TSCA section 5(a)(2) states that EPA’s determination that a use of a chemical substance
is a significant new use must be made after consideration of all relevant factors, including:
• The projected volume of manufacturing and processing of a chemical substance.
• The extent to which a use changes the type or form of exposure of human beings or the
environment to a chemical substance.
• The extent to which a use increases the magnitude and duration of exposure of human
beings or the environment to a chemical substance.
• The reasonably anticipated manner and methods of manufacturing, processing,
distribution in commerce, and disposal of a chemical substance.
In determining what would constitute a significant new use for the chemical substances
that are the subject of these SNURs, EPA considered relevant information about the toxicity of
the chemical substances, and potential human exposures and environmental releases that may be
associated with the substances, in the context of the four bulleted TSCA section 5(a)(2) factors
listed in this unit and discussed in Unit III.
These proposed SNURs include PMN substances that are subject to Orders issued under
TSCA section 5(e)(1)(A), as required by the determinations made by EPA under TSCA section
5(a)(3)(B). The TSCA Orders require protective measures to limit exposures or otherwise
mitigate the potential unreasonable risk. The proposed SNURs identify as significant new uses
any manufacturing, processing, use, distribution in commerce, or disposal that does not conform
to the restrictions imposed by the underlying TSCA Orders, consistent with TSCA section
5(f)(4).

B. Rationale and Objectives of the SNURs
1. Rationale.
Under TSCA, no person may manufacture a new chemical substance or manufacture or
process a chemical substance for a significant new use until EPA makes a determination as
described in TSCA section 5(a) and takes any required action. The issuance of a SNUR is not a
risk determination itself, only a notification requirement for “significant new uses,” so that the
Agency has the opportunity to review the SNUN for the significant new use and make a TSCA
section 5(a)(3) risk determination.
During review of the PMNs submitted for the chemical substances, 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. The basis for such findings is outlined in Unit IV. Based on these findings, TSCA
section 5(e) Orders requiring the use of appropriate exposure controls were negotiated with the
PMN submitters. As a general matter, EPA believes it is necessary to follow the TSCA Orders
with a SNUR that identifies the absence of those protective measures as significant new uses to
ensure that all manufacturers and processors – not just the original submitter – are held to the
same standard.
2. Objectives.
EPA is proposing these SNURs because the Agency wants:
• To identify as significant new uses any manufacturing, processing, use, distribution in
commerce, or disposal that does not conform to the restrictions imposed by the underlying TSCA
Orders, consistent with TSCA section 5(f)(4).
• To have an opportunity to review and evaluate data submitted in a SNUN before the
submitter begins manufacturing or processing a listed chemical substance for the described
significant new use.
• To be obligated to make a determination under TSCA section 5(a)(3) regarding the use

described in the SNUN, under the conditions of use. The Agency will either determine under
TSCA section 5(a)(3)(C) that the significant new use is not likely to present an unreasonable
risk, including an unreasonable risk to a potentially exposed or susceptible subpopulation
identified as relevant by the Administrator under the conditions of use, or make a determination
under TSCA section 5(a)(3)(A) or (B) and take the required regulatory action associated with the
determination, before manufacture or processing for the significant new use of the chemical
substance can occur.
Issuance of a proposed SNUR for a chemical substance does not signify that the chemical
substance is listed on the TSCA Chemical Substance Inventory (TSCA) Inventory. Guidance on
how to determine if a chemical substance is on the TSCA Inventory is available at
https://www.epa.gov/tsca-inventory.
C. Significant New Uses Claimed as CBI.
EPA is proposing to establish certain significant new uses which have been claimed as
CBI subject to Agency confidentiality regulations at 40 CFR part 2 and 40 CFR part 720, subpart
E. Absent a final determination or other disposition of the confidentiality claim under 40 CFR
part 2 procedures, EPA is required to keep this information confidential. EPA promulgated a
procedure to deal with the situation where a specific significant new use is CBI, at 40 CFR
721.11.
Under these procedures a manufacturer or processor may request EPA to determine
whether a specific use would be a significant new use under the rule. The manufacturer or
processor must show that it has a bona fide intent to manufacture or process the chemical
substance and must identify the specific use for which it intends 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 tell the person whether the use
identified in the bona fide submission would be a significant new use under the rule. 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.
If EPA determines that the use identified in the bona fide submission would not be a
significant new use, i.e., the use does not meet the criteria specified in the rule for a significant
new use, that person can manufacture or process the chemical substance so long as the
significant new use trigger is not met. In the case of a production volume trigger, this means that
the aggregate annual production volume does not exceed that identified in the bona fide
submission to EPA. Because of confidentiality concerns, EPA does not typically disclose the
actual production volume that constitutes the use trigger. Thus, if the person later intends to
exceed that volume, a new bona fide submission would be necessary to determine whether that
higher volume would be a significant new use.
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 conditions of 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 conditions of use of the chemical substance is not

likely to present an unreasonable risk, EPA is required under TSCA section 5(g) to publish a
statement of EPA’s findings in the Federal Register.
As discussed in Unit I.C.2., persons who export or intend to export a chemical substance
identified in a proposed or final SNUR are subject to the export notification provisions of TSCA
section 12(b), and persons who import a chemical substance identified in a final SNUR are
subject to the TSCA section 13 import certification requirements. See also https://www.epa.gov/
tsca-import-export-requirements.
E. Applicability of the Proposed SNURs to Uses Occurring Before the Effective Date of the Final
Rule
To establish a significant new use, EPA must determine that the use is not ongoing.
The chemical substances subject to this proposed rule have undergone premanufacture review
and received determinations under TSCA section 5(a)(3)(C). TSCA Orders have been issued for
these substances and the PMN submitters are required by the TSCA Orders to submit a SNUN
before undertaking activities which 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 at https://www.epa.gov/reviewing-new-chemicals-undertoxic-substances-control-act-tsca.
2. Development and submission of information.
EPA recognizes that TSCA section 5 does not require development of any particular new
information (e.g., generating test data) before submission of a SNUN. There is an exception: If a
person is required to submit information for a chemical substance pursuant to a rule, order or
consent agreement under TSCA section 4, then TSCA section 5(b)(1)(A) requires such
information to be submitted to EPA at the time of submission of the SNUN.
In the absence of a rule, TSCA Order, or consent agreement under TSCA section 4
covering the chemical substance, persons are required only to submit information in their
possession or control and to describe any other information known to or reasonably ascertainable
by them (see 40 CFR 720.50). However, upon review of PMNs and SNUNs, the Agency has the
authority to require appropriate testing. To assist with EPA’s analysis of the SNUN, submitters
are encouraged, but not required, to provide the potentially useful information identified for the
chemical substance in Unit III.C.
EPA strongly encourages persons, before performing any testing, to consult with the
Agency pertaining to protocol selection. Furthermore, pursuant to TSCA section 4(h), which
pertains to reduction of testing in vertebrate animals, EPA encourages consultation with the
Agency on the use of alternative test methods and strategies (also called New Approach
Methodologies, or NAMs), if available, to generate the recommended test data. EPA encourages
dialog with Agency representatives to help determine how best the submitter can meet both the

data needs and the objective of TSCA section 4(h). For more information on alternative test
methods and strategies to reduce vertebrate animal testing, visit https://www.epa.gov/assessingand-managing-chemicals-under-tsca/alternative-test-methods-and-strategies-reduce.

The potentially useful information described in Unit III.C. for these chemical substances
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 information
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 to provide useful information with their SNUN submission.
SNUN submitters should be aware that EPA will be better able to evaluate SNUNs which
provide detailed information on the following:
• 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 [INSERT DATE OF PUBLICATION IN THE FEDERAL
REGISTER] as the cutoff date for determining whether the new use is ongoing. This designation
is explained in more detail in Unit II.D.
B. What information is provided for each chemical substance?
For each chemical substance identified in Unit III.C., EPA provides the following
information:
• PMN number (the proposed CFR citation assigned in the regulatory text section of this
document).
• Chemical name (generic name, if the specific name is claimed as CBI).
• Chemical Abstracts Service Registry Number (CASRN) (if assigned for non-

confidential chemical identities).
• Effective date of and basis for the TSCA Order.
• Potentially useful information.
The regulatory text section of the proposed rule specifies the activities designated as
significant new uses. Certain new uses, including production volume limits and other uses
designated in the proposed rules, may be claimed as CBI.
These proposed rules 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 the proposed SNURs in this document?
The substances subject to the proposed rules in this document are as follows:
PMN Number (proposed CFR citation): P-20-96 (40 CFR 721.11829).
Chemical Name: Unsaturated dicarboxylic acid polymer with 2-(dialkylamino)alkyl-alkylalkanoate, N,N-dialkyl-alkene amide, 2-propenamide and salt of alkyl-substituted alkene
sulfonate (generic).
CASRN: Not available.
Effective Date of TSCA Order: November 8, 2022.
Basis for TSCA Order: The PMN states that the generic (non-confidential) use will be in a
papermaking process. Based on a structural alert for aliphatic amines, the acid moieties, and a
confidential residual substance, EPA has identified concerns for skin, eye, and respiratory tract
irritation. Based on comparison to analogous polyamphoteric polymers, EPA predicts toxicity to
aquatic organisms may occur at concentrations that exceed 490 ppb. The Order was issued under

TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of
sufficient information to permit a reasoned evaluation, the substance may present an
unreasonable risk of injury to human health or the environment. To protect against these risks,
the Order requires:
• Use of personal protective equipment where there is a potential for dermal exposure;
• Use of a NIOSH-certified gas/vapor respirator with an APF of at least 10 where there is
a potential for inhalation exposure;
• No manufacture of the PMN substance unless the percentage of the confidential reactant
listed in the Order represents 10% or less (by weight) of the PMN substance;
• No release of the PMN substance resulting in surface water concentrations that exceed
490 ppb; and
• 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.
PMN Number (proposed CFR citation): P-21-2 (40 CFR 721.11830).
Chemical Name: Octadecanoic acid, 12-hydroxy-, polymer with aziridine, 2-oxepanone and
tetrahydro-2H-pyran-2-one, reaction products with disubstituted heteropolycycle (generic).
CASRN: Not available.

Effective Date of TSCA Order: October 4, 2022.
Basis for TSCA Order: The PMN states that the generic (non-confidential) use will be as a
polymer in coatings. Based on a structural alert for aliphatic amines, EPA has identified concerns
for lung effects (cationic binding) and irritation to the skin, eyes, and respiratory tract. Based on
comparison to analogous polycationic polymers, EPA predicts toxicity to aquatic organisms may
occur at concentrations that exceed 50 ppb. The Order was issued under TSCA sections
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient
information to permit a reasoned evaluation, the substance may present an unreasonable risk of
injury to human health or the environment. To protect against these risks, the Order requires:
• No use of the PMN substance in consumer products;
• No release of the PMN substance, or any waste stream containing the PMN substance,
in surface water concentrations that exceed 50 ppb;
• Use of personal protective equipment where there is a potential for dermal exposure;
• Use of a NIOSH-certified respirator with an APF of at least 50 where there is a potential
for inhalation exposure during non-spray applications;
• Use of a NIOSH-certified respirator with an APF of at least 10,000 where there is a
potential for inhalation exposure during spray applications;
• Establishment of a hazard communication program, including human health and
environmental precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a “significant new use” the absence of these
protective measures.
Potentially Useful Information: EPA has determined that certain information may be potentially
useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or
processor is considering submitting a SNUN for a significant new use that will be designated by
this SNUR. EPA has determined that the results of skin irritation, eye irritation/corrosion,
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.
PMN Number (proposed CFR citation): P-21-19 (40 CFR 721.11831).
Chemical Name: Ethyl 4-alkyl-2-oxocycloalkanecarboxylate (generic).
CASRN: Not available.
Effective Date of TSCA Order: November 17, 2022.
Basis for TSCA Order: The PMN states that the generic (non-confidential) use will be as a
fragrance ingredient. Based on submitted test data on PMN substance, EPA has identified
concerns for acute neurotoxicity and kidney effects, and EPA predicts toxicity to aquatic
organisms may occur at concentrations that exceed 460 ppb. The Order was issued under TSCA
sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient
information to permit a reasoned evaluation, the substance may present an unreasonable risk of
injury to human health or the environment. To protect against these risks, the Order requires:
• No use of the PMN substance other than as a fragrance ingredient for making fragrance
oils by blending (mixing) with other fragrance ingredients;
• No use of the PMN substance at a concentration of 0.5% (by weight) or greater in
consumer products;
• No domestic manufacture of the PMN substance (i.e., import only);
• Use of personal protective equipment where there is a potential for dermal exposure;
and
• Establishment of a hazard communication program, including human health and
environmental precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a “significant new use” the absence of these
protective measures.
Potentially Useful Information: EPA has determined that certain information may be potentially

useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or
processor is considering submitting a SNUN for a significant new use that will be designated by
this SNUR. EPA has determined that the results of aquatic toxicity testing may be potentially
useful to characterize the environmental effects of the PMN substances. Although the Order does
not require these tests, the Order’s restrictions remain in effect until the Order is modified or
revoked by EPA based on submission of this or other relevant information.
PMN Numbers (proposed CFR citations): P-21-48 (40 CFR 721.11832), P-21-130 (40 CFR
721.11833), P-21-131 (40 CFR 721.11834), P-21-177 (40 CFR 721.11835), P-21-204 (40 CFR
721.11836), and P-22-12 (40 CFR 721.11837).
Chemical Names: Sulfonium, tricarbocyclic-, polyfluoropolyhydro-2,2-dicarbocyclic -4,7methano-1,3-benzodioxole-5-alkanesulfonate (1:1) (generic) (P-21-48), Sulfonium,
tricarbocyclic-, 2-[3,5-bis(haloalkyl)phenyl]-.alpha., .alpha., .beta., .beta.-polyhalopolyhydro-2alkyl-4,7-alkano-1,3-heteropolycyclic-5-alkanesulfonate (1:1) (generic) (P-21-130), Sulfonium,
tricarbocyclic-, 2-(4-alkoxyhalocarbomonocyclic)-.alpha., .alpha., .beta., .beta.polyhalopolyhydro-4,7-methano-1,3-heteropolycyclic-5-alkanesulfonate (1:1) (generic) (P-21131), Sulfonium, monocarbocyclicbisarylpolyhaloalkyl, .alpha., .alpha., .beta., .beta.polyhalopolyhydro-2,2-diaryl-4,7-methano-1,3-heteropolycyclic-5-alkanesulfonate (1:1)
(generic) (P-21-177), Sulfonium, bis(3,4-polyhalocarbocyclic)aryl-, .alpha., .alpha., .beta., .beta.polyhalopolyhydro-2,2-diaryl-4,7-methano-1,3-heteropolycyclic-5-alkanesulfonate (1:1)
(generic) (P-21-204), and Sulfonium, tricarbocyclic-, 2-heteroatom-substituted-4(halocarbocyclic)carboxylate (1:1) (generic) (P-22-12).
CASRNs: Not available.
Effective Date of TSCA Order: December 22, 2022.
Basis for TSCA Order: The PMNs state that the generic (non-confidential) use of the PMN
substances will be for photolithography. Based on the physical/chemical properties of the PMN
substances (as described in the New Chemical Program’s PBT category at 64 FR 60194;

November 1999) and in the absence of data, the PMN substances and photolysis products are
potentially persistent, bioaccumulative, and toxic (PBT) chemicals. EPA estimates that the PMN
substances will persist in the environment for more than two months and that their potential to
bioaccumulate is unknown. EPA estimates that the photolysis products will persist in the
environment for more than two months and estimates a bioaccumulation factor of greater than or
equal to 1,000. Based on the reactivity of the PMN substances, EPA has identified concerns for
photosensitization. Based on information provided in the SDS and data on analogues, EPA has
also identified concerns for irritation to the skin, eyes, and respiratory tract. Based on data on
sulfonium compounds, EPA has also identified concerns for acute toxicity, irritation to the skin,
eyes, and respiratory tract, eye corrosion, ocular lethality, neurological effects, and systemic
effects for the sulfonium cation of the PMN substances. Based on comparison to analogous
substances, EPA has also identified concerns for mutagenicity. Based on analogue data, EPA has
also identified concerns for thyroid, liver, and reproductive (developmental) toxicity for the
anion for PMNs P-21-48, P-21-130, P-21-131, P-21-177, and P-21-204. Based on test data on
salicylic acid and sodium salicylate and a structural alert for phenols, EPA has also identified
concerns for acute toxicity, eye irritation, neurotoxicity, reproductive and developmental effects
for P-22-12. Based on protein binding alert for benzyl phenyl ethers, EPA has also identified
concerns for skin sensitization for P-22-12. Based on data on a potential incineration product,
EPA has identified concerns for local and systemic effects. Based on insufficient information,
the PMN substance has unknown toxicity to aquatic organisms. The Order was issued under
TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of
sufficient information to permit a reasoned evaluation, the substances may present an
unreasonable risk of injury to human health or the environment. To protect against these risks,
the Order requires:
• No manufacture of any of the PMN substances beyond the time limits specified in the
Order without submittal to EPA the results of certain testing described in the Testing section of

the Order;
• Use of personal protective equipment where there is a potential for dermal exposure;
• Establishment of a hazard communication program, including human health and
environmental precautionary statements on each label and in the SDS;
• No modification of the processing or use of the PMN substances in any way that
generates a vapor, dust, mist, or aerosol in a non-enclosed process;
• Use of the PMN substances only for the confidential use stated in the Order;
• No domestic manufacture of the PMN substances (i.e., import only);
• Import of the PMN substances only in solution, or in any form in sealed containers
weighing 5 kilograms or less; and
• No exceedance of the confidential annual importation volumes stated in 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.
PMN Number (proposed CFR citation): P-21-55 (40 CFR 721.11838).
Chemical Name: Fatty acids, reaction products with polyamine-polyacid polymer and fatty acid
(generic).
CASRN: Not available.
Effective Date of TSCA Order: March 29, 2022.
Basis for TSCA Order: The PMN states that the generic (non-confidential) use will be as an

adhesive used for coating formulations. Based on structural alert for aliphatic amines, EPA has
identified concerns for irritation to the skin, eyes, and respiratory tract. Based on a potential
metabolite and confidential residual, EPA has also identified concerns for systemic (body
weight, adrenal, and clinical chemistry), 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 or the environment. To protect against these risks,
the Order requires:
• Manufacture of the PMN substance only in a manner that results in an amine value of
no more than 127 mg KOH/g;
• Use of a NIOSH-certified particulate respirator with an APF of at least 10 where there
is a potential for inhalation exposure;
• Use of personal protective equipment where there is a potential for dermal exposure;
and
• 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 skin irritation, eye damage, 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.

PMN Numbers (proposed CFR citations): P-21-71 (40 CFR 721.11839) and P-21-72 (40
CFR 721.11840).
Chemical Names: Poly[oxy(methyl-1,2-ethandiyl)], .alpha.-(dithiocarboxy)-.omega.-(1methylethoxy)-, sodium salt (1:1) (P-21-71) and Poly[oxy(methyl-1,2-ethandiyl)], .alpha.(dithiocarboxy)-.omega.-butoxy-, sodium salt (1:1) (P-21-72).
CASRNs: 2304726-53-0 (P-21-71) and 2304726-56-3 (P-21-72).
Effective Date of TSCA Order: October 5, 2022.
Basis for TSCA Order: The PMNs state that the uses will be as flotation aids in sulfide ore
mining. Based on surfactant properties, EPA has identified concerns for lung effects and skin and
eye irritation. Based on data on carbon disulfide, EPA has also identified concerns for
neurotoxicity and systemic, reproductive, and developmental effects for the hydrolysis product.
Based on comparison to analogous esters, EPA predicts toxicity to aquatic organisms may occur
at concentrations that exceed 350 ppb (P-21-71) and 150 ppb (P-21-72). The Order was issued
under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence
of sufficient information to permit a reasoned evaluation, the substances may present an
unreasonable risk of injury to human health or the environment. To protect against these risks,
the Order requires:
• Use of personal protective equipment where there is a potential for dermal exposure;
• Use of a NIOSH-certified respirator with an APF of at least 10 where there is a potential
for inhalation exposure;
• Establishment of a hazard communication program, including human health and
environmental precautionary statements on each label and in the SDS;
• No use of the PMN substances other than as flotation aids in sulfide ore mining at mines
with valid permits (State, Federal, or Tribal) for operations and waste handling;
• No domestic manufacture of the PMN substances (i.e., import only); and
• No release of the PMN substances resulting in surface water concentrations that exceed

150 ppb.
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, developmental toxicity, eye
damage, neurotoxicity, reproductive toxicity, skin irritation, specific target organ toxicity, and
pulmonary effects 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.
PMN Number (proposed CFR citation): P-21-73 (40 CFR 721. 11841).
Chemical Name: 1,4-Cyclohexanedicarboxylic acid, 1,4-dinonyl ester, branched and linear.
CASRN: 2449089-78-3.
Effective Date of TSCA Order: September 1, 2022.
Basis for TSCA Order: The PMN states that the use will be as a plasticizer in PVC articles like
roofing membranes, flooring, or coated fabrics. Based on the potential hydrolysis product, EPA
has identified concerns for reproductive and developmental effects. Based on test data on the
PMN substance and comparison to neutral organic substances, EPA predicts the PMN substance
may be toxic to aquatic organisms and has unknown toxicity to sediment dwelling environmental
organisms. 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:
• Use of personal protective equipment where there is a potential for dermal exposure;

• No processing or use of the PMN substance in a consumer product;
• No processing or use of the PMN substance other than as a plasticizer in polyvinyl
chloride (PVC) articles;
• Establishment of a hazard communication program, including human health and
environmental precautionary statements on each label and in the SDS;
• No release of the PMN substance, or any waste stream containing the PMN substance,
into water or into any environmental media destined for water.
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 this test, 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.
PMN Number (proposed CFR citation): P-21-74 (40 CFR 721.11842).
Chemical Name: 1,3-Butadiene, homopolymer, hydrogenated, 2-(ethenyloxy)ethyl-terminated.
CASRN: 2511154-73-5.
Effective Date of TSCA Order: March 28, 2022.
Basis for TSCA Order: The PMN states that the generic (non-confidential) use will be as a resin
component of an adhesive formulation. Based on potential epoxidation of the terminal C=C
bonds, EPA has identified concerns for dermal and respiratory sensitization, reproductive and
developmental effects, genotoxicity, and carcinogenicity. 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:
• No use of the PMN substance in consumer products;
• No manufacture, processing, or use of the PMN substance in any manner that results in
inhalation exposure;
• Use of the PMN substance only for the confidential use listed in the Order;
• No release of the PMN substance, or any waste stream containing the PMN substance,
into waters of the United States;
• Use of personal protective equipment where there is a potential for dermal exposure;
• 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 sensitization, germ cell mutagenicity, specific
target organ toxicity, reproductive toxicity, and developmental 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.
PMN Numbers (proposed CFR citations): P-21-89 (40 CFR 721.11843) and P-21-90 (40
CFR 721.11844).
Chemical Names: Lignin, modified, reaction products with alkylamine by-products,
hydrochlorides (generic) (P-21-89) and Lignin, modified, reaction products with alkylamine byproducts (generic) (P-21-90).
CASRNs: Not available.

Effective Date of TSCA Order: July 25, 2022.
Basis for TSCA Order: The PMNs state that the generic (non-confidential) uses will be as an
emulsifier (P-21-89) and a component in paving formulations (P-21-90). Based on the cationic
binding of amines to lung membranes, EPA has identified concerns for lung effects. Based on
analogue data, EPA has also identified concerns for corrosion to the skin and eyes for P-21-90.
Based on comparison to analogous polycationic polymers, EPA predicts toxicity to aquatic
organisms may occur at concentrations that exceed 2 ppb (P-21-89). Based on comparison to
analogous polyamphoteric polymers, EPA predicts toxicity to aquatic organisms may occur at
concentrations that exceed 12 ppb (P-21-90). The Order was issued under TSCA sections
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient
information to permit a reasoned evaluation, the substances may present an unreasonable risk of
injury to human health or the environment. To protect against these risks, the Order requires:
• Use of personal protective equipment where there is a potential for dermal exposure to
P-21-90;
• Establishment of a hazard communication program, including human health and
environmental precautionary statements on each label and in the SDS;
• No manufacture, processing, or use in any manner that results in inhalation exposure;
• No manufacture, processing, or use in any manner that results in direct air releases to
the environment except during loading or unloading of transport containers;
• No release of PMN P-21-89 resulting in surface water concentrations that exceed 2 ppb;
and
• No release of PMN P-21-90 resulting in surface water concentrations that exceed 12
ppb.
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 and specific target organ
toxicity testing may be potentially useful to characterize the health and environmental effects of
the PMN substances. EPA has also determined that the results of skin corrosion and serious eye
damage testing may be potentially useful to characterize the health effects of P-21-90. 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.
PMN Number (proposed CFR citation): P-21-124 (40 CFR 721.11845).
Chemical Name: Sulfonium, triphenyl-, salt with fluoroalkyl 5-sulfobicyclo[2.2.1]heptane
carboxylate (1:1) (generic).
CASRN: Not available.
Effective Date of TSCA Order: December 22, 2022.
Basis for TSCA Order: The PMN states that the generic (non-confidential) use of the PMN
substance will be for photolithography. Based on the physical/chemical properties of the PMN
substance (as described in the New Chemical Program’s PBT category at 64 FR 60194;
November 1999) and in the absence of data, the PMN substance is a potentially persistent,
bioaccumulative, and toxic (PBT) chemical. EPA estimates that the PMN substance may
potentially persist in the environment for more than six months and estimates a bioaccumulation
factor of greater than or equal to 1,000. Based on the reactivity of the PMN substance, EPA has
identified concerns for photosensitization. Based on data on sulfonium compounds, EPA has also
identified concerns for acute toxicity, irritation to the skin, eyes, and respiratory tract, eye
corrosion, ocular lethality, neurological effects, and systemic effects for the sulfonium cation of
the PMN substance. Based on comparison to analogous substances, EPA has also identified
concerns for genetic toxicity. Based on perfluoro analogue data, EPA has also identified
concerns for thyroid, liver, and reproductive (developmental) toxicity for the anion. Based on

data on a potential incineration product, EPA has also identified concerns for local and systemic
effects. Based on insufficient information, the PMN substance has unknown toxicity to aquatic
organisms. 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:
• No manufacture of the PMN substance beyond the time limits specified in the Order
without submittal to EPA the results of certain testing described in the Testing section of the
Order;
• Use of personal protective equipment where there is a potential for dermal exposure;
• Establishment of a hazard communication program, including human health and
environmental precautionary statements on each label and in the SDS;
• No modification of the processing or use of the PMN substance in any way that
generates a vapor, dust, mist, or aerosol in a non-enclosed process;
• Use of the PMN substance only as an onium salt that generates strong or weak acid in
lithography process;
• No domestic manufacture of the PMN substance (i.e., import only);
• Import of the PMN substance only in solution, or in any form in sealed containers
weighing 5 kilograms or less; and
• No exceedance of the confidential annual importation volume listed in the Order.
The proposed SNUR would designate as a “significant new use” the absence of these
protective measures.
Potentially Useful Information: EPA has determined that certain information about the
physical/chemical properties, fate, bioaccumulation, environmental hazard, and human health
effects of the PMN substance may be potentially useful in support of a request by the PMN
submitter to modify the Order, or if a manufacturer or processor is considering submitting a

SNUN for a significant new use that will be designated by this SNUR. The submitter has agreed
not to exceed the time limits specified in the Order without performing the required Tier I and
Tier II testing outlined in the Testing section of the Order.
PMN Number (proposed CFR citation): P-21-137 (40 CFR 721.11846).
Chemical Name: Triazine-trione, tris(isocyanatoalkyl)-, polymer with substituted diisocyanato
alkylcarbomonocycle, hydro-hydroxypoly(oxyalkanediyl)and hydro-hydroxypoly[oxy(alkylalkanediyl)], aliphatic alkyl amine-blocked (generic).
CASRN: Not available.
Effective Date of TSCA Order: August 3, 2022.
Basis for TSCA Order: The PMN states that the generic (non-confidential) use will be as an
industrial additive. Based on information in the SDS, comparison to analogous chemical
substances, and test data on a residual, EPA has identified concerns for eye, skin, and respiratory
irritation, eye and skin corrosion, acute toxicity, acute neurotoxicity, systemic effects, portal-ofentry effects, mutagenicity, and reproductive effects. Based on the potential of the PMN
substance as a crosslinker, EPA has also identified concerns for skin sensitization. Based on
comparison to analogous substituted ureas, EPA predicts toxicity to aquatic organisms may
occur at concentrations that exceed 15 ppb. The Order was issued under TSCA sections
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient
information to permit a reasoned evaluation, the substance may present an unreasonable risk of
injury to human health or the environment. To protect against these risks, the Order requires:
• No use of the PMN substance in consumer products;
• No manufacture, processing, or use of the PMN substance in any manner that results in
inhalation exposure;
• No release of the PMN substance, or any waste stream containing the PMN substance,
in surface water concentrations that exceed 15 ppb;
• Use of personal protective equipment where there is a potential for dermal exposure;

• Establishment of a hazard communication program, including human health and
environmental precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a “significant new use” the absence of these
protective measures.
Potentially Useful Information: EPA has determined that certain information may be potentially
useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or
processor is considering submitting a SNUN for a significant new use that will be designated by
this SNUR. EPA has determined that the results of reproductive toxicity, 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.
PMN Number (proposed CFR citation): P-21-138 (40 CFR 721.11847).
Chemical Name: Lithium metal oxide (generic).
CASRN: Not available.
Effective Date of TSCA Order: October 31, 2022.
Basis for TSCA Order: The PMN states that the use will be as an electrode material for use in the
manufacture of batteries. Based on the physical/chemical properties of the PMN substance 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 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 or the environment. To protect against these risks,
the Order requires:
• Use of personal protective equipment where there is a potential for dermal exposure;

• Use of a NIOSH-certified particulate respirator with an APF of at least 1,000 if the dust
control capture and reduction rate is at less than 90% where there is a potential for inhalation
exposure;
• Use of a NIOSH-certified particulate respirator with an APF of at least 50 if the dust
control capture and reduction rate is at least 90% where there is a potential for inhalation
exposure;
• No domestic manufacture of the PMN substance (i.e., import only);
• No disposal of the PMN substance or waste streams containing the PMN substance
other than by landfill or incineration;
• No use of the PMN substance in a consumer product;
• No use of the PMN substance other than in the manufacture of batteries; and
• 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 pulmonary testing may be potentially useful
to characterize the health effects of the PMN substance. Although the Order does not require this
test, 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.
PMN Number (proposed CFR citation): P-21-140 (40 CFR 721.11848).
Chemical Name: Soybean oil, oleic acid-high, epoxidized.
CASRN: 2410202-82-1.
Effective Date of TSCA Order: September 1, 2022.

Basis for TSCA Order: The PMN states that the use will be as a chemical intermediate to prepare
acrylate-containing oil, which is subsequently polymerized to prepare a viscosity modifier for
asphalt. Based on analogous epoxides, EPA has identified concerns for reproductive effects and
carcinogenicity. Based on OECD QSAR Toolbox results and test data for a functional analogue,
4-vinylcyclohexene diepoxide, EPA has also identified concerns for carcinogenicity. Based on
test data for an analogue, epoxidized soybean oil, EPA has also identified concerns for systemic
effects and reproductive effects. Based on OECD QSAR Toolbox identification as a respiratory
sensitizer, the new chemical substance having bifunctional reactive groups which can crosslink
proteins, and the respiratory tract not having a stratum corneum protective layer like the skin to
inhibit absorption, EPA has also identified concerns for respiratory sensitization. Based on
insufficient information, toxicity to sediment-dwelling organisms is unknown. 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:
• Use of personal protective equipment where there is a potential for dermal exposure;
• No release of the PMN substance, or any waste steam containing the PMN substance,
into waters of the United States;
• No use of the PMN substance other than as a chemical intermediate to prepare acrylatecontaining oil, which is subsequently polymerized to prepare a viscosity modifier for asphalt;
• No manufacture, processing, or use of the PMN substance in any manner that results in
inhalation exposure; and
• Establishment of a hazard communication program, including human health and
environmental precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a “significant new use” the absence of these
protective measures.

Potentially Useful Information: EPA has determined that certain information may be potentially
useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or
processor is considering submitting a SNUN for a significant new use that will be designated by
this SNUR. EPA has determined that the results of specific target organ toxicity, skin irritation,
eye irritation/corrosion, reproductive toxicity, developmental toxicity, carcinogenicity, and
sediment organism 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.
PMN Number (proposed CFR citation): P-21-180 (40 CFR 721.11849).
Chemical Name: Sulfonium, (halocarbomonocycle)diphenyl-, salt with 1-heterosubstituted-2methylalkyl trihalobenzoate (1:1) (generic).
CASRN: Not available.
Effective Date of TSCA Order: December 20, 2022.
Basis for TSCA Order: The PMN states that the generic (non-confidential) use of the PMN
substance will be for microlithography for electronic device manufacturing. Based on the
physical/chemical properties of the PMN substance (as described in the New Chemical
Program’s PBT category at 64 FR 60194; November 1999) and the absence of data, the PMN
substance is a potentially persistent, bioaccumulative, and toxic (PBT) chemical. EPA estimates
that the PMN substance will persist in the environment for more than six months and the
bioaccumulation potential is unknown and that the cation photolysis product has the potential to
bioaccumulate and be persistent in the environment. Based on the reactivity of the PMN
substance, EPA has identified concerns for photosensitization. Based on data on sulfonium
compounds and information provided in the SDS, EPA has also identified concerns for acute
toxicity, irritation to the skin, eyes, and respiratory tract, eye corrosion, ocular lethality,
neurological effects, and systemic effects for the sulfonium cation of the PMN substance. Based

on comparison to analogous substances, EPA has also identified concerns for mutagenicity.
Based on analogue data and the OECD QSAR Toolbox, EPA has also identified concerns for
thyroid, liver, and reproductive (developmental) toxicity and skin sensitization for the anion.
Based on data on a potential incineration product, EPA has identified concerns for local and
systemic effects. Based on insufficient information, the PMN substance has unknown toxicity to
aquatic organisms. 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:
• No manufacture of the PMN substance beyond the time limits specified in the Order
without submittal to EPA the results of certain testing described in the Testing section of the
Order;
• Use of personal protective equipment where there is a potential for dermal exposure;
• Establishment of a hazard communication program, including human health and
environmental precautionary statements on each label and in the SDS;
• No modification of the processing or use of the PMN substance in any way that
generates a vapor, dust, mist, or aerosol in a non-enclosed process;
• Use of the PMN substance only for the confidential use stated in the Order;
• No domestic manufacture of the PMN substance (i.e., import only);
• Import of the PMN substance only in solution, or in any form in sealed containers
weighing 5 kilograms or less; and
• No exceedance of the confidential annual importation volume listed in the Order.
The proposed SNUR would designate as a “significant new use” the absence of these
protective measures.
Potentially Useful Information: EPA has determined that certain information about the
physical/chemical properties, fate, bioaccumulation, environmental hazard, and human health

effects of the PMN substance may be potentially useful in support of a request by the PMN
submitter to modify the Order, or if a manufacturer or processor is considering submitting a
SNUN for a significant new use that will be designated by this SNUR. The submitter has agreed
not to exceed the time limits specified in the Order without performing the required Tier I and
Tier II testing outlined in the Testing section of the Order.
PMN Number (proposed CFR citation): P-21-199 (40 CFR 721.11850).
Chemical Name: 1,6-Disubstituted hexane (generic).
CASRN: Not available.
Effective Date of TSCA Order: November 7, 2022.
Basis for TSCA Order: The PMN states that the generic (non-confidential) use will be as a
processing aid. Based on comparison to analogous chemical substances, EPA has identified
concerns for acute toxicity, irritation to the skin, eyes, and respiratory tract, respiratory and skin
sensitization, neurotoxicity, systemic effects, genotoxicity, reproductive, and developmental
effects. Based on structural alerts, EPA has also identified concerns for carcinogenicity. Based
on comparison to analogous chemical substances, EPA predicts toxicity to aquatic organisms
may occur at concentrations that exceed 23 ppb. The Order was issued under TSCA sections
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient
information to permit a reasoned evaluation, the substance may present an unreasonable risk of
injury to human health or the environment. To protect against these risks, the Order requires:
• Use of personal protective equipment where there is a potential for dermal exposure;
• No release of the PMN substance, or any waste steam containing the PMN substance,
into waters of the United States;
• No manufacture, processing, or use of the PMN substance in any manner that results in
inhalation exposure;
• No disposal of the PMN substance or waste streams containing the PMN substance
other than by hazardous waste incineration;

• No use of the PMN substance in a consumer product; and
• 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 damage, skin irritation,
pulmonary effects, skin sensitization, specific target organ toxicity, neurotoxicity, genetic
toxicity, reproductive toxicity, developmental toxicity, carcinogenicity, 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.
PMN Number (proposed CFR citation): P-21-201 (40 CFR 721.11851).
Chemical Name: 1,3-Propanediaminium, 2-hydroxy-N1,N1,N1,N3,N3-pentamethyl-N3tetradecyl-, chloride (1:2); 1,3-Propanediaminium, N1-hexadecyl-2-hydroxy-N1,N1,N3,N3,N3pentamethyl-, chloride (1:2); 1,3-Propanediaminium, 2-hydroxy-N1,N1,N1,N3,N3-pentamethylN3-octadecyl-, chloride (1:2); 1,3-Propanediaminium, 2-hydroxy-N1,N1,N1,N3,N3pentamethyl-N3-octadecen-1-yl, chloride (1:2).
CASRNs: 1622255-87-1; 63560-76-9; 197862-16-1; and 2748681-38-9.
Effective Date of TSCA Order: April 12, 2022.
Basis for TSCA Order: The PMN states that the use will be as a surfactant in a cationic latex
asphalt emulsion formulation. Based on the intended use and structure, EPA has identified
concerns for surfactant effects of the lung. Based on comparison to analogous chemical

substances, EPA also identified concerns for skin irritation/corrosion, eye irritation/corrosion,
mortality, systemic, and neurotoxic, and developmental effects. Based on comparison to
analogous cationic (quaternary ammonium) surfactants, EPA predicts toxicity to aquatic
organisms may occur at concentrations that exceed 21 ppb. The Order was issued under TSCA
sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient
information to permit a reasoned evaluation, the substance may present an unreasonable risk of
injury to human health or the environment. To protect against these risks, the Order requires:
• No use of the PMN substance in consumer products;
• No manufacture, processing, or use of the PMN substance in any manner or method that
results in inhalation exposure;
• No release of the PMN substance, or any waste stream containing the PMN substance,
in surface water concentrations that exceed 21 ppb;
• Use of personal protective equipment where there is a potential for dermal exposure;
and
• 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, acute toxicity, neurotoxicity,
specific target organ toxicity, pulmonary effects, developmental toxicity, skin irritation, skin
corrosion, and eye damage 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.
PMN Number (proposed CFR citation): P-21-206 (40 CFR 721.11852).
Chemical Name: Alkanes, branched and linear (generic).
CASRN: Not available.
Effective Date of TSCA Order: March 25, 2022.
Basis for TSCA Order: The PMN states that the generic (non-confidential) use of the PMN
substance will be as a component of gasoline. Based on data on analogous mixtures, EPA has
identified concerns for skin irritation, neurotoxicity, systemic toxicity, developmental toxicity,
portal-of-entry effects via the inhalation route, and carcinogenicity. Based on data on
representative constituents of the PMN substance, EPA has also identified concerns for eye
irritation, acute toxicity, acute neurotoxicity, reproductive toxicity, portal-of-entry effects via the
oral route, aspiration hazard, and genetic toxicity. Based on information provided in the SDS,
EPA has also identified concerns for aspiration hazard, flammability, skin irritation, eye
irritation, and acute neurotoxicity. Based on the chemical composition, EPA has also identified
hydrocarbon pneumonia/aspiration hazard. EPA also assumes respiratory tract irritation is a
hazard. Based on comparison to analogous neutral organic substances, EPA predicts toxicity to
aquatic organisms may occur at concentrations that exceed 3 ppb. The Order was issued under
TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of
sufficient information to permit a reasoned evaluation, the substance may present an
unreasonable risk of injury to human health or the environment. To protect against these risks,
the Order requires:
• No manufacture, processing, or use of the PMN substance other than for use as a fuel,
fuel additive, or regulated blendstock subject to 40 CFR part 79 or 1090, including as a
component of gasoline or ethanol base fuel (E85);
• Use of personal protective equipment where there is a potential for dermal exposure;
and

• Establishment of a hazard communication program.
The proposed SNUR would designate as a “significant new use” the absence of these
protective measures.
Potentially Useful Information: EPA has determined that certain information may be potentially
useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or
processor is considering submitting a SNUN for a significant new use that will be designated by
this SNUR. EPA has determined that the results of skin irritation, eye irritation, respiratory
depression/irritation, hydrocarbon pneumonia/aspiration hazard, reproductive developmental
toxicity, systemic toxicity, genetic toxicity, carcinogenicity, aquatic toxicity, and consumer
inhalation exposure at gas stations 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.
PMN Numbers (proposed CFR citations): P-22-29 (40 CFR 721.11853), P-22-30 (40 CFR
721.11854), and P-22-31 (40 CFR 721.11855).
Chemical Names: Polyester with 1,4-benzenedicarboxylic acid, 1,4- dimethyl 1,4benzenedicarboxylate, 2,2-dimethyl-1,3-propanediol, dodecanedioic acid, 1,2-ethanediol,
aliphatic polyester, 3- hydroxy-2,2-dimethylpropyl 3-hydroxy-2,2-dimethylpropanoate, 1,3isobenzofurandione and 1,1'-methylenebis[isocyanatobenzene] (generic) (P-22-29), Polyester
with 1,4-benzenedicarboxylic acid, 2,2-dimethyl-1,3-propanediol, dodecanedioic acid, 1,2ethanediol, aliphatic polyester, 3-hydroxy-2,2-dimethylpropyl 3- hydroxy-2,2dimethylpropanoate, 1,3-isobenzofurandione and 1,1'-methylenebis[4- isocyanatobenzene]
(generic) (P-22-30), and Polyester with 1,4-benzenedicarboxylic acid, 2,2-dimethyl-1,3propanediol, dodecanedioic acid, 1,2-ethanediol, aliphatic polyester, 3-hydroxy-2,2dimethylpropyl 3-hydroxy-2,2-dimethylpropanoate, 1,3-isobenzofurandione and 1,1'methylenebis[isocyanatobenzene] (generic) (P-22-31).

CASRNs: Not available.
Effective Date of TSCA Order: January 6, 2023.
Basis for TSCA Order: The PMNs state that the uses will be as industrial adhesives. Based on
comparison to analogous diisocyanates, EPA has identified concerns for irritation to skin, eyes,
and respiratory tract, skin and respiratory sensitization, and pulmonary toxicity for the low
molecular weight species present in 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 substance may present an unreasonable risk of
injury to human health or the environment. To protect against these risks, the Order requires:
• No manufacture, processing, or use of the PMN substances in any manner that results in
inhalation exposure;
• No use of the PMN substances in consumer products;
• Use of personal protective equipment where there is a potential for dermal exposure;
• 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 pulmonary effects, skin irritation, eye
irritation, skin sensitization, 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.
PMN Number (proposed CFR citation): P-22-55 (40 CFR 721.11856).

Chemical Name: Aromatic sulfonium tricyclo fluoroalkyl sulfonic acid salt (generic).
CASRN: Not available.
Effective Date of TSCA Order: October 31, 2022.
Basis for TSCA Order: The PMN states that the generic (non-confidential) use of the PMN
substance will be as a photoacid generator (PAG) for use in electronics industry. Based on the
physical/chemical properties of the PMN substance (as described in the New Chemical
Program’s PBT category at 64 FR 60194; November 1999) and in the absence of data, the PMN
substance is a potentially persistent, bioaccumulative, and toxic (PBT) chemical. EPA estimates
that the PMN substance will persist in the environment for more than six months and estimates a
bioaccumulation factor of greater than or equal to 1,000. Based on the reactivity of the PMN
substance, EPA has identified concerns for photosensitization. Based on test data on the PMN
substance and information provided in the SDS, EPA has also identified concerns for eye
irritation and corrosion, skin and eye corrosion, and corrosion to mucous membranes. Based on
data on sulfonium compounds, EPA has also identified concerns for acute toxicity, irritation to
the skin, eyes, and respiratory tract, eye corrosion, ocular lethality, neurological effects, and
systemic effects for the sulfonium cation of the PMN substance. Based on comparison to
analogous substances, EPA has also identified concerns for genetic and acute toxicity, eye
irritation and corrosion, and systemic effects. Based on perfluoro analogue data, EPA has also
identified concerns for thyroid, liver, and reproductive (developmental) toxicity for the anion of
the PMN substance. Based on data on a potential incineration product, EPA identified hazards
for local and systemic effects. EPA was unable to estimate the environmental hazard of this
substance. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I),
based on a finding that in the absence of sufficient information to permit a reasoned evaluation,
the substance may present an unreasonable risk of injury to human health or the environment. To
protect against these risks, the Order requires:
• No manufacture of the PMN substance beyond the time limits specified in the Order

without submittal to EPA the results of certain testing described in the Testing section of the
Order;
• Use of personal protective equipment where there is a potential for dermal exposure;
• Establishment of a hazard communication program, including human health and
environmental precautionary statements on each label and in the SDS;
• No modification of the processing or use of the PMN substance in any way that
generates a vapor, dust, mist, or aerosol in a non-enclosed process;
• Use of the PMN substance only as a photoacid generator;
• No domestic manufacture of the PMN substance (i.e., import only);
• Import of the PMN substance only in solution, or in any form in sealed containers
weighing 5 kilograms or less; and
• No exceedance of the confidential annual importation volume listed in the Order.
The proposed SNUR would designate as a “significant new use” the absence of these
protective measures.
Potentially Useful Information: EPA has determined that certain information about the
physical/chemical properties, fate, bioaccumulation, environmental hazard, and human health
effects of the PMN substance may be potentially useful in support of a request by the PMN
submitter to modify the Order, or if a manufacturer or processor is considering submitting a
SNUN for a significant new use that will be designated by this SNUR. The submitter has agreed
not to exceed the time limits specified in the Order without performing the required Tier I and
Tier II testing outlined in the Testing section of the Order.
PMN Number (proposed CFR citation): P-22-69 (40 CFR 721.11857).
Chemical Name: Fluoroheteroacid, metal salt (generic).
CASRN: Not available.
Effective Date of TSCA Order: November 24, 2022.
Basis for TSCA Order: The PMN states that the generic (non-confidential) use will be as a

component in batteries. Based on submitted test data on the PMN substance, EPA has identified
concerns for acute toxicity, skin, respiratory and eye corrosion, skin sensitization, and systemic
effects. Based on data on the hydrolysis product, EPA has also identified concerns for systemic,
reproductive, and developmental effects. Based on submitted test data on the PMN substance and
comparison to analogous chemical substances, EPA predicts toxicity to aquatic organisms may
occur at concentrations that exceed 380 ppb. The Order was issued under TSCA sections
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient
information to permit a reasoned evaluation, the substance may present an unreasonable risk of
injury to human health or the environment. To protect against these risks, the Order requires:
• Use of personal protective equipment where there is a potential for dermal exposure;
• Use of a NIOSH-certified particulate respirator with an APF of at least 50 where there
is a potential for inhalation exposure;
• No use of the PMN substance in a consumer product;
• No release of the PMN substance resulting in surface water concentrations that exceed
380 ppb; and
• 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, developmental effects,
specific target organ toxicity, and chronic fish 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.
PMN Number (proposed CFR citation): P-22-147 (40 CFR 721.11858).
Chemical Name: Hydrocarbons, C5-10.
CASRN: 2779559-23-6.
Effective Date of TSCA Order: November 2, 2022.
Basis for TSCA Order: The PMN states that the use will be as a feedstock for gasoline for racing
fuels. Based on comparison to analogous chemical mixtures and data on the worst case
constituents of the PMN substance, EPA has identified concerns for irritation to the skin, eye,
and respiratory tract, acute toxicity, developmental and reproductive effects, systemic effects,
aspiration hazard, genetic toxicity, and carcinogenicity. Based on data on constituents of the
mixture, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 25
ppb. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on
a finding that in the absence of sufficient information to permit a reasoned evaluation, the
substance may present an unreasonable risk of injury to human health and the environment. To
protect against these risks, the Order requires:
• Import, processing, and use of the PMN substance only as a feedstock for gasoline
containing no more than 64% of the PMN substance where the imported gasoline mixture is
regulated under applicable EPA regulations for fuels, fuel additives, and regulated blendstocks
(40 CFR part 1090), fuel additives, and regulated blendstocks (40 CFR part 1090), registration of
fuels and fuel additives (40 CFR part 79).
• No domestic manufacture of the PMN substance (i.e., import only);
• Use of personal protective equipment where there is a potential for dermal exposure;
and
• Establishment of a hazard communication program.
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, skin irritation, eye irritation,
reproductive/developmental toxicity, systemic toxicity, genetic toxicity, and carcinogenicity
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.
PMN Numbers (proposed CFR citations): P-22-150 (40 CFR 721.11859), P-22-152 (40 CFR
721.11860), P-22-161 (40 CFR 721.11861), and P-22-177 (40 CFR 721.11862).
Chemical Names: Sulfonium, tricarbocyclic-, alpha, alpha, beta, beta-polyhalopolyhydroheteropolycyclic-5-alkanesulfonate (1:1) (generic) (P-22-150), Sulfonium, tricarbocyclic-, 2heteroatom-substituted-4-alkylcarbomonocyclecarboxylate (1:1) (generic) (P-22-152),
Sulfonium, tricarbocyclic-, salt with [polyhydro-2-alkyl-5-(polyhalo-2-heteroalkyl)- alkano-1,3hetropolycyclic]alkyl polyhaloaryl ester (1:1) (generic) (P-22-161), and Sulfonium,
tricarbocyclic-, alpha, alpha, beta, beta-polyhalopolyhydro-heteropolycyclic-5-alkanesulfonate
(1:1) (generic) (P-22-177).
CASRNs: Not available.
Effective Date of TSCA Order: February 6, 2023.
Basis for TSCA Order: The PMNs state that the generic (non-confidential) use of the PMN
substances will be for photolithography. Based on the physical/chemical properties of the PMN
substances (as described in the New Chemical Program’s PBT category at 64 FR 60194;
November 1999) and in the absence of data, the PMN substances are potentially persistent,
bioaccumulative, and toxic (PBT) chemicals. EPA estimates that the PMN substances will persist
in the environment for more than six months and have unknown bioaccumulation potential. EPA

also estimates that the cation photodegradation products will persist in the environment for more
than two months and have bioaccumulation factors over 1000. Based on data on sulfonium
compounds, EPA has identified concerns for acute toxicity, irritation to the skin, eyes, and
respiratory tract, eye corrosion, ocular lethality, neurological effects, and systemic effects for the
sulfonium cations of the PMN substances. Based on the photoreactivity of the PMN substances,
EPA has also identified concerns for photosensitization. Based on the reactivity of the PMN
substances, EPA has also identified irritation to the skin, eyes, and respiratory tract. Based on
comparison to analogous substances, EPA has also identified concerns for mutagenicity. Based
on OECD QSAR Toolbox results, EPA has also identified hazards for skin sensitization for P22-150, P-22-161, and P-22-177, and carcinogenicity for P-22-161 and P-22-177, and skin
sensitization and carcinogenicity for the anion of P-22-161. Based on anion analogue data, EPA
has also identified concerns for acute toxicity, skin irritation, eye corrosion, GI tract irritation,
and systemic, reproductive and developmental effects for P-22-150, P-22-161, and P-22-177.
Based on data on a potential incineration by-product, EPA has also identified concerns for local,
neurotoxic, and systemic effects. EPA was unable to estimate the environmental hazard of these
substances. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I),
based on a finding that in the absence of sufficient information to permit a reasoned evaluation,
the substances may present an unreasonable risk of injury to human health or the environment.
To protect against these risks, the Order requires:
• No manufacture of any of the PMN substances beyond the time limits specified in the
Order without submittal to EPA the results of certain testing described in the Testing section of
the Order;
• Use of personal protective equipment where there is a potential for dermal exposure;
• Establishment of a hazard communication program, including human health and
environmental precautionary statements on each label and in the SDS;
• No processing of the PMN substances in any way that generates a vapor, dust, mist, or

aerosol in a non-enclosed process;
• Use of the PMN substances only for the confidential use stated in the Order;
• No domestic manufacture of the PMN substances (i.e., import only);
• Import of the PMN substances only in solution, or in any form in sealed containers
weighing 5 kilograms or less; and
• No exceedance of the confidential annual importation volumes listed in 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
https://www.epa.gov/laws-regulations-and-executive-orders.
A. Executive Order 12866: Regulatory Planning and Review and Executive Order 14094:
Modernizing Regulatory 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), as amended
by Executive Order 14094 (88 FR 21879, April 11, 2023).
B. 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. Send any 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.
C. 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 16 in Federal fiscal year (FY) FY2018, five in
FY2019, seven in FY2020, 13 in FY2021, 11 in FY2022, and 15 in FY2023, 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) (FRL5597-1), 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.
D. Unfunded Mandates Reform Act (UMRA)

This action does not contain an unfunded mandate of $100 million or more in any one
year (in 1995 dollars) 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. 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.
E. 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.
F. 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.
G. 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 human health, 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 any of these chemical substances for an activity that is
designated as a significant new use by this rulemaking. This notification allows EPA to assess
the conditions of use to identify potential risks and take appropriate actions before the activities
commence.
H. 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.

I. 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).
J. Executive Order 12898: Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations and Executive Order 14096: Revitalizing Our
Nation’s Commitment to Environmental Justice for All
This action does not concern human health or environmental conditions and therefore
cannot be evaluated with respect to the potential for disproportionate impacts on non-white and
low-income populations in accordance with Executive Order 12898 (59 FR 7629, February 16,
1994) and Executive Order 14096 (88 FR 25251, April 26, 2023). Although this action does not
concern human health or environmental conditions, the premanufacture notifications required by
these SNURs allow EPA to assess the conditions of use to identify potential disproportionate
risks and take appropriate actions before the activities commence.
List of Subjects in 40 CFR Part 721
Environmental protection, Chemicals, Hazardous substances, Reporting and
recordkeeping requirements.
Dated: June 4, 2024.
Mary Elissa Reaves,
Director, Office of Pollution Prevention and Toxics.

Therefore, 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
1. The authority citation for part 721 continues to read as follows:
Authority: 15 U.S.C. 2604, 2607, and 2625(c).
2. Add §§ 721.11829 through 721.11862 to subpart E to read as follows:
Subpart E–Significant New Uses for Specific Chemical Substances
Sec.
*

*

*

*

*

721.11829 Unsaturated dicarboxylic acid polymer with 2-(dialkylamino)alkyl-alkyl-alkanoate,
N,N-dialkyl-alkene amide, 2-propenamide and salt of alkyl-substituted alkene sulfonate
(generic).
721.11830 Octadecanoic acid, 12-hydroxy-, polymer with aziridine, 2-oxepanone and
tetrahydro-2H-pyran-2-one, reaction products with disubstituted heteropolycycle (generic).
721.11831 Ethyl 4-alkyl-2-oxocycloalkanecarboxylate (generic).
721.11832 Sulfonium, tricarbocyclic-, polyfluoropolyhydro-2,2-dicarbocyclic -4,7-methano- 1,3benzodioxole-5-alkanesulfonate (1:1) (generic).
721.11833 Sulfonium, tricarbocyclic-, 2-[3,5-bis(haloalkyl)phenyl]-.alpha., .alpha., .beta., .beta.polyhalopolyhydro-2-alkyl-4,7-alkano-1,3-heteropolycyclic-5-alkanesulfonate (1:1) generic).
721.11834 Sulfonium, tricarbocyclic-, 2-(4-alkoxyhalocarbomonocyclic)-.alpha., .alpha., .beta.,
.beta.-polyhalopolyhydro-4,7-methano-1,3-heteropolycyclic-5-alkanesulfonate (1:1) (generic).
721.11835 Sulfonium, monocarbocyclicbisarylpolyhaloalkyl, .alpha., .alpha., .beta., .beta.polyhalopolyhydro-2,2-diaryl-4,7-methano-1,3-heteropolycyclic-5-alkanesulfonate (1:1)
(generic).
721.11836 Sulfonium, bis(3,4-polyhalocarbocyclic)aryl-, .alpha., .alpha., .beta, .beta.polyhalopolyhydro-2,2-diaryl-4,7-methano-1,3-heteropolycyclic-5-alkanesulfonate (1:1)
(generic).
721.11837 Sulfonium, tricarbocyclic-, 2-heteroatom-substituted-4-(halocarbocyclic)carboxylate
(1:1) (generic).
721.11838 Fatty acids, reaction products with polyamine-polyacid polymer and fatty acid
(generic).
721.11839 Poly[oxy(methyl-1,2-ethandiyl)], .alpha.-(dithiocarboxy)-.omega.-(1-methylethoxy)-,
sodium salt (1:1).
721.11840 Poly[oxy(methyl-1,2-ethandiyl)], .alpha.-(dithiocarboxy)-.omega.-butoxy-, sodium
salt (1:1).
721.11841 1,4-Cyclohexanedicarboxylic acid, 1,4-dinonyl ester, branched and linear.
721.11842 1,3-Butadiene, homopolymer, hydrogenated, 2-(ethenyloxy)ethyl-terminated.
721.11843 Lignin, modified, reaction products with alkylamine by-products, hydrochlorides
(generic).
721.11844 Lignin, modified, reaction products with alkylamine by-products (generic).
721.11845 Sulfonium, triphenyl-, salt with fluoroalkyl 5-sulfobicyclo[2.2.1]heptane carboxylate
(1:1) (generic).
721.11846 Triazine-trione, tris(isocyanatoalkyl)-, polymer with substituted diisocyanato

alkylcarbomonocycle, hydro-hydroxypoly(oxyalkanediyl)and hydro-hydroxypoly[oxy(alkylalkanediyl)], aliphatic alkyl amine-blocked (generic).
721.11847 Lithium metal oxide (generic).
721.11848 Soybean oil, oleic acid-high, epoxidized.
721.11849 Sulfonium, (halocarbomonocycle)diphenyl-, salt with 1-heterosubstituted-2methylalkyl trihalobenzoate (1:1) (generic).
721.11850 1,6-Disubstituted hexane (generic).
721.11851 1,3-Propanediaminium, 2-hydroxy-N1,N1,N1,N3,N3-pentamethyl-N3-tetradecyl-,
chloride (1:2); 1,3-Propanediaminium, N1-hexadecyl-2-hydroxy-N1,N1,N3,N3,N3-pentamethyl, chloride (1:2); 1,3-Propanediaminium, 2-hydroxy-N1,N1,N1,N3,N3-pentamethyl-N3octadecyl-, chloride (1:2); 1,3-Propanediaminium, 2-hydroxy-N1,N1,N1,N3,N3-pentamethylN3-octadecen-1-yl, chloride (1:2).
721.11852 Alkanes, branched and linear (generic).
721.11853 Polyester with 1,4-benzenedicarboxylic acid, 1,4- dimethyl 1,4-benzenedicarboxylate,
2,2-dimethyl-1,3-propanediol, dodecanedioic acid, 1,2-ethanediol, aliphatic polyester, 3hydroxy-2,2-dimethylpropyl 3-hydroxy-2,2-dimethylpropanoate, 1,3-isobenzofurandione and
1,1'-methylenebis[isocyanatobenzene] (generic).
721.11854 Polyester with 1,4-benzenedicarboxylic acid, 2,2-dimethyl-1,3-propanediol,
dodecanedioic acid, 1,2-ethanediol, aliphatic polyester, 3-hydroxy-2,2-dimethylpropyl 3hydroxy-2,2-dimethylpropanoate, 1,3-isobenzofurandione and 1,1'-methylenebis[4isocyanatobenzene] (generic).
721.11855 Polyester with 1,4-benzenedicarboxylic acid, 2,2-dimethyl-1,3-propanediol,
dodecanedioic acid, 1,2-ethanediol, aliphatic polyester, 3-hydroxy-2,2-dimethylpropyl 3hydroxy-2,2-dimethylpropanoate, 1,3-isobenzofurandione and 1,1'methylenebis[isocyanatobenzene] (generic).
721.11856 Aromatic sulfonium tricyclo fluoroalkyl sulfonic acid salt (generic).
721.11857 Fluoroheteroacid, metal salt (generic).
721.11858 Hydrocarbons, C5-10.
721.11859 Sulfonium, tricarbocyclic-, alpha, alpha, beta, beta-polyhalopolyhydroheteropolycyclic-5-alkanesulfonate (1:1) (generic).
721.11860 Sulfonium, tricarbocyclic-, 2-heteroatom-substituted-4alkylcarbomonocyclecarboxylate (1:1) (generic).
721.11861 Sulfonium, tricarbocyclic-, salt with [polyhydro-2-alkyl-5-(polyhalo-2-heteroalkyl)alkano-1,3-hetropolycyclic]alkyl polyhaloaryl ester (1:1) (generic).
721.11862 Sulfonium, tricarbocyclic-, alpha, alpha, beta, beta-polyhalopolyhydroheteropolycyclic-5-alkanesulfonate (1:1) (generic).
*

*

*

*

*

§ 721.11829 Unsaturated dicarboxylic acid polymer with 2-(dialkylamino)alkyl-alkylalkanoate, N,N-dialkyl-alkene amide, 2-propenamide and salt of alkyl-substituted alkene
sulfonate (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical
substance identified generically as unsaturated dicarboxylic acid polymer with 2(dialkylamino)alkyl-alkyl-alkanoate, N,N-dialkyl-alkene amide, 2-propenamide and salt of alkylsubstituted alkene sulfonate (PMN P-20-96) 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 § 721.63(a)(1), (3) through
(5), (b), and (c). When determining which persons are reasonably likely to be exposed as
required for § 721.63(a)(1) and (4), engineering control measures (e.g., enclosure or confinement
of the operation, general and local ventilation) or administrative control measures (e.g.,
workplace policies and procedures) shall be considered and implemented to prevent exposure,
where feasible. For purposes of § 721.63(a)(5), respirators must provide a National Institute for
Occupational Safety and Health (NIOSH) assigned protection factor (APF) of at least 10. For
purposes of § 721.63(b), the concentration is set at 1.0%.
(ii) Hazard communication. Requirements as specified in § 721.72(a) through (f), (g)(1),
(3), and (5). For purposes of § 721.72(e), the concentration is set at 1.0%. For purposes of §
721.72(g)(1), this substance may cause: skin corrosion and eye irritation. For purposes of §
721.72(g)(3), this substance may be: toxic to aquatic life. Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System and Hazard Communication
Standard may be used.
(iii) Industrial, commercial, and consumer activities. It is a significant new use to
manufacture the substance unless the percentage of the confidential reactant listed in the Order
represents 10% or less (by weight) of the substance.
(iv) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4),
where N=490.
(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 § 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 §

721.185 apply to this section.
§ 721.11830 Octadecanoic acid, 12-hydroxy-, polymer with aziridine, 2-oxepanone and
tetrahydro-2H-pyran-2-one, reaction products with disubstituted heteropolycycle (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical
substance identified generically as octadecanoic acid, 12-hydroxy-, polymer with aziridine, 2oxepanone and tetrahydro-2H-pyran-2-one, reaction products with disubstituted heteropolycycle
(PMN P-21-2) is subject to reporting under this section for the significant new uses described in
paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the
substance after they have been completely reacted or cured.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (3) through
(5), (b), and (c). When determining which persons are reasonably likely to be exposed as
required for § 721.63(a)(1) and (4), engineering control measures (e.g., enclosure or confinement
of the operation, general and local ventilation) or administrative control measures (e.g.,
workplace policies and procedures) shall be considered and implemented to prevent exposure,
where feasible. For purposes of § 721.63(a)(5), respirators must provide a National Institute for
Occupational Safety and Health (NIOSH) assigned protection factor (APF) of at least 50 during
non-spray applications or 10,000 during spray applications. For purposes of § 721.63(b), the
concentration is set at 1.0%.
(ii) Hazard communication. Requirements as specified in § 721.72(a) through (f), (g)(1),
(3), and (5). For purposes of § 721.72(e), the concentration is set at 1.0%. For purposes of §
721.72(g)(1), this substance may cause: skin irritation, eye irritation, and specific target organ
toxicity. For purposes of § 721.72(g)(3), this substance may be: toxic to aquatic life. Alternative
hazard and warning statements that meet the criteria of the Globally Harmonized System and
Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer use. Requirements as specified in § 721.80(o).

(iv) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4),
where N=50.
(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 § 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 §
721.185 apply to this section.
§ 721.11831 Ethyl 4-alkyl-2-oxocycloalkanecarboxylate (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical
substance identified generically as ethyl 4-alkyl-2-oxocycloalkanecarboxylate (PMN P-21-19) 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
the substance is present at less than 0.5% in formulation.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1) and (3), (b),
and (c). When determining which persons are reasonably likely to be exposed as required for §
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. For
purposes of § 721.63(b), the concentration is set at 1.0%.
(ii) Hazard communication. Requirements as specified in § 721.72(a) through (f), (g)(1),
(3), and (5). For purposes of § 721.72(e), the concentration is set at 1.0%. For purposes of §
721.72(g)(1), this substance may cause: specific target organ toxicity. For purposes of §
721.72(g)(3), this substance may be: toxic to aquatic life. Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System and Hazard Communication

Standard may be used.
(iii) Industrial, commercial, and consumer use. Requirements as specified in § 721.80(f).
It is a significant new use to use the substance other than as a fragrance ingredient for making
fragrance oils by blending (mixing) with other fragrance ingredients. It is a significant new use
to use the substance at a concentration of 0.5% (by weight) or greater in consumer products.
(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 § 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 §
721.185 apply to this section.
§ 721.11832 Sulfonium, tricarbocyclic-, polyfluoropolyhydro-2,2-dicarbocyclic -4,7methano- 1,3-benzodioxole-5-alkanesulfonate (1:1) (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical
substance identified generically as sulfonium, tricarbocyclic-, polyfluoropolyhydro-2,2dicarbocyclic -4,7-methano- 1,3-benzodioxole-5-alkanesulfonate (1:1) (PMN P-21-48) 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 § 721.63(a)(1), (2)(i) and
(iii), (3), and (c). When determining which persons are reasonably likely to be exposed as
required for § 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 § 721.72(a) through (d), (f),
(g)(1), (2)(i) through (iii), (v), (3)(i) and (ii), and (5). For purposes of § 721.72(g)(1), this
substance may cause: acute toxicity, skin irritation, serious eye damage, skin sensitization,
genetic toxicity, 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 §
721.80(f), (k), and (t). It is a significant new use to import the substance other than in solution or
in sealed containers weighing 5 kilograms or less. It is a significant new use to process the
substance in any way that generates 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 § 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 §
721.185 apply to this section.
§ 721.11833 Sulfonium, tricarbocyclic-, 2-[3,5-bis(haloalkyl)phenyl]-.alpha., .alpha., .beta.,
.beta.-polyhalopolyhydro-2-alkyl-4,7-alkano-1,3-heteropolycyclic-5-alkanesulfonate (1:1)
(generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical
substance identified generically as sulfonium, tricarbocyclic-, 2-[3,5-bis(haloalkyl)phenyl].alpha., .alpha., .beta., .beta.-polyhalopolyhydro-2-alkyl-4,7-alkano-1,3-heteropolycyclic-5alkanesulfonate (1:1) (PMN P-21-130) 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 § 721.63(a)(1), (2)(i) and
(iii), (3), and (c). When determining which persons are reasonably likely to be exposed as
required for § 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 § 721.72(a) through (d), (f),
(g)(1), (2)(i) through (iii), (v), (3)(i) and (ii), and (5). For purposes of § 721.72(g)(1), this
substance may cause: eye irritation, acute toxicity, skin irritation, serious eye damage, skin
sensitization, genetic toxicity, 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 §
721.80(f), (k), and (t). It is a significant new use to import the substance other than in solution or
in sealed containers weighing 5 kilograms or less. It is a significant new use to process the
substance in any way that generates 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 § 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 §
721.185 apply to this section.
§ 721.11834 Sulfonium, tricarbocyclic-, 2-(4-alkoxyhalocarbomonocyclic)-.alpha., .alpha.,
.beta., .beta.-polyhalopolyhydro-4,7-methano-1,3-heteropolycyclic-5-alkanesulfonate (1:1)
(generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical
substance identified generically as sulfonium, tricarbocyclic-, 2-(4-alkoxyhalocarbomonocyclic).alpha., .alpha., .beta., .beta.-polyhalopolyhydro-4,7-methano-1,3-heteropolycyclic-5alkanesulfonate (1:1) (PMN P-21-131) 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 § 721.63(a)(1), (2)(i) and
(iii), (3), and (c). When determining which persons are reasonably likely to be exposed as
required for § 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 § 721.72(a) through (d), (f),
(g)(1), (2)(i) through (iii), (v), (3)(i) and (ii), and (5). For purposes of § 721.72(g)(1), this
substance may cause: acute toxicity, skin irritation, serious eye damage, skin sensitization,
genetic toxicity, 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 §
721.80(f), (k), and (t). It is a significant new use to import the substance other than in solution or
in sealed containers weighing 5 kilograms or less. It is a significant new use to process the
substance in any way that generates 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 § 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 §
721.185 apply to this section.
§ 721.11835 Sulfonium, monocarbocyclicbisarylpolyhaloalkyl, .alpha., .alpha., .beta., .beta.polyhalopolyhydro-2,2-diaryl-4,7-methano-1,3-heteropolycyclic-5-alkanesulfonate (1:1)
(generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical
substance identified generically as sulfonium, monocarbocyclicbisarylpolyhaloalkyl, .alpha.,
.alpha., .beta., .beta.-polyhalopolyhydro-2,2-diaryl-4,7-methano-1,3-heteropolycyclic-5alkanesulfonate (1:1) (PMN P-21-177) 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 § 721.63(a)(1), (2)(i) and
(iii), (3), and (c). When determining which persons are reasonably likely to be exposed as
required for § 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 § 721.72(a) through (d), (f),
(g)(1), (2)(i) through (iii), (v), (3)(i) and (ii), and (5). For purposes of § 721.72(g)(1), this
substance may cause: acute toxicity, skin irritation, serious eye damage, skin sensitization,
genetic toxicity, 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 §
721.80(f), (k), and (t). It is a significant new use to import the substance other than in solution or
in sealed containers weighing 5 kilograms or less. It is a significant new use to process the
substance in any way that generates 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 § 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 §
721.185 apply to this section.
§ 721.11836 Sulfonium, bis(3,4-polyhalocarbocyclic)aryl-, .alpha., .alpha., .beta., .beta.polyhalopolyhydro-2,2-diaryl-4,7-methano-1,3-heteropolycyclic-5-alkanesulfonate (1:1)
(generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical
substance identified generically as sulfonium, bis(3,4-polyhalocarbocyclic)aryl-, .alpha., .alpha.,
.beta., .beta.-polyhalopolyhydro-2,2-diaryl-4,7-methano-1,3-heteropolycyclic-5-alkanesulfonate

(1:1) (PMN P-21-204) 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 § 721.63(a)(1), (2)(i) and
(iii), (3), and (c). When determining which persons are reasonably likely to be exposed as
required for § 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 § 721.72(a) through (d), (f),
(g)(1), (2)(i) through (iii), (v), (3)(i) and (ii), and (5). For purposes of § 721.72(g)(1), this
substance may cause: acute toxicity, skin irritation, serious eye damage, skin sensitization,
genetic toxicity, 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 §
721.80(f), (k), and (t). It is a significant new use to import the substance other than in solution or
in sealed containers weighing 5 kilograms or less. It is a significant new use to process the
substance in any way that generates 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 § 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 §
721.185 apply to this section.
§ 721.11837 Sulfonium, tricarbocyclic-, 2-heteroatom-substituted-4(halocarbocyclic)carboxylate (1:1) (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical
substance identified generically as sulfonium, tricarbocyclic-, 2-heteroatom-substituted-4(halocarbocyclic)carboxylate (1:1) (PMN P-22-12) 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 § 721.63(a)(1), (2)(i) and
(iii), (3), and (c). When determining which persons are reasonably likely to be exposed as
required for § 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 § 721.72(a) through (d), (f),
(g)(1), (2)(i) through (iii), (v), (3)(i) and (ii), and (5). For purposes of § 721.72(g)(1), this
substance may cause: eye irritation, acute toxicity, skin irritation, serious eye damage, skin
sensitization, genetic toxicity, 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 §

721.80(f), (k), and (t). It is a significant new use to import the substance other than in solution or
in sealed containers weighing 5 kilograms or less. It is a significant new use to process the
substance in any way that generates 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 § 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 §
721.185 apply to this section.
§ 721.11838 Fatty acids, reaction products with polyamine-polyacid polymer and fatty acid
(generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical
substance identified generically as fatty acids, reaction products with polyamine-polyacid
polymer and fatty acid (PMN P-21-55) 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 they have been completely reacted
(cured).
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (3) through
(5), (b), and (c). When determining which persons are reasonably likely to be exposed as
required for § 721.63(a)(1) and (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 § 721.63(a)(5), respirators must provide a National
Institute for Occupational Safety and Health (NIOSH) assigned protection factor (APF) of at

least 10. For purposes of § 721.63(b), the concentration is set at 1.0%.
(ii) Hazard communication. Requirements as specified in § 721.72(a) through (f), (g)(1),
and (5). For purposes of § 721.72(e), the concentration is set at 1.0%. For purposes of §
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 Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer use. It is a significant new use to manufacture
the substance in a manner that results in an amine value of more than 127 mg KOH/g.
(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 § 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 §
721.185 apply to this section.
§ 721.11839 Poly[oxy(methyl-1,2-ethandiyl)], .alpha.-(dithiocarboxy)-.omega.-(1methylethoxy)-, sodium salt (1:1).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical
substance identified as poly[oxy(methyl-1,2-ethandiyl)], .alpha.-(dithiocarboxy)-.omega.-(1methylethoxy)-, sodium salt (1:1) (PMN P-21-71; CASRN 2304726-53-0) 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 § 721.63(a)(1), (3) through
(5), (b), and (c). When determining which persons are reasonably likely to be exposed as
required for § 721.63(a)(1) and (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 § 721.63(a)(5), respirators must provide a National
Institute for Occupational Safety and Health (NIOSH) assigned protection factor (APF) of at
least 10. For purposes of § 721.63(b), the concentration is set at 1.0%.
(ii) Hazard communication. Requirements as specified in § 721.72(a) through (f), (g)(1),
(3), and (5). For the purposes of § 721.72(e), the concentration is set at 1.0%. For purposes of §
721.72(g)(1), this substance may cause skin irritation, eye irritation, reproductive toxicity, and
specific target organ toxicity. For purposes of § 721.72(g)(3), this substance may be toxic to
aquatic life. Alternative hazard and warning statements that meet the criteria of the Globally
Harmonized System and Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer use. Requirements as specified in § 721.80 (f).
It is a significant new use to use the substance other than as a floatation aid in sulfide ore mining
at mines with valid permits (State, Federal, or Tribal) for operations and waste handling.
(iv) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4),
where N=150.
(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 § 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 §
721.185 apply to this section.
§ 721.11840 Poly[oxy(methyl-1,2-ethandiyl)], .alpha.-(dithiocarboxy)-.omega.-butoxy-,
sodium salt (1:1).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical
substance identified as poly[oxy(methyl-1,2-ethandiyl)], .alpha.-(dithiocarboxy)-.omega.-butoxy, sodium salt (1:1) (PMN P-21-72; CASRN 2304726-56-3) 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 § 721.63(a)(1), (3) through
(5), (b), and (c). When determining which persons are reasonably likely to be exposed as
required for § 721.63(a)(1) and (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 § 721.63(a)(5), respirators must provide a National
Institute for Occupational Safety and Health (NIOSH) assigned protection factor (APF) of at
least 10. For purposes of § 721.63(b), the concentration is set at 1.0%.
(ii) Hazard communication. Requirements as specified in § 721.72(a) through (f), (g)(1),
(3), and (5). For the purposes of § 721.72(e), the concentration is set at 1.0%. For purposes of §
721.72(g)(1), this substance may cause skin irritation, eye irritation, reproductive toxicity, and
specific target organ toxicity. For purposes of § 721.72(g)(3), this substance may be toxic to
aquatic life. Alternative hazard and warning statements that meet the criteria of the Globally
Harmonized System and Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer use. Requirements as specified in § 721.80(f).
It is a significant new use to use the substance other than as a floatation aid in sulfide ore mining
at mines with valid permits (State, Federal, or Tribal) for operations and waste handling.
(iv) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4),
where N=150.
(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 § 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 §
721.185 apply to this section.

§ 721.11841 1,4-Cyclohexanedicarboxylic acid, 1,4-dinonyl ester, branched and linear.
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical
substance identified as 1,4-cyclohexanedicarboxylic acid, 1,4-dinonyl ester, branched and linear
(PMN P-21-73; CASRN 2449089-78-3) 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 bound in a
PVC article.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (3), (b), and
(c). When determining which persons are reasonably likely to be exposed as required for §
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. For
purposes of § 721.63(b), the concentration is set at 1.0%.
(ii) Hazard communication. Requirements as specified in § 721.72(a) through (f), (g)(1),
(3), and (5). For the purposes of § 721.72(e) the concentration is set at 1.0%. For purposes of §
721.72(g)(1), this substance may cause: reproductive toxicity and specific target organ toxicity.
For the purposes of § 721.72(g)(3), this substance may be: toxic to aquatic life. Alternative
hazard and warning statements that meet the criteria of the Globally Harmonized System and
Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements as specified in §
721.80(o). It is a significant new use to process or use the substance other than as a plasticizer in
polyvinyl chloride (PVC) articles. It is a significant new use to process the substance for use in a
consumer product.
(iv) Release to water. Requirements as specified in § 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 § 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 §
721.185 apply to this section.
§ 721.11842 1,3-Butadiene, homopolymer, hydrogenated, 2-(ethenyloxy)ethyl-terminated.
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical
substance identified as 1,3-butadiene, homopolymer, hydrogenated, 2-(ethenyloxy)ethylterminated (PMN P-21-74; CASRN 2511154-73-5) 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.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (3), and (c).
When determining which persons are reasonably likely to be exposed as required for §
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 § 721.72(a) through (d), (f),
(g)(1), and (5). For purposes of § 721.72(g)(1), this substance may cause: respiratory
sensitization, skin sensitization, germ cell mutagenicity, specific target organ toxicity, and
reproductive toxicity. Alternative hazard and warning statements that meet the criteria of the
Globally Harmonized System and Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer use. Requirements as specified in § 721.80(k)
and (o). It is a significant new use to manufacture, process, or use the substance in any manner
that results in inhalation exposure.

(iv) Release to water. Requirements as specified in § 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 § 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 §
721.185 apply to this section.
§ 721.11843 Lignin, modified, reaction products with alkylamine by-products,
hydrochlorides (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical
substance identified generically as lignin, modified, reaction products with alkylamine byproducts, hydrochlorides (PMN P-21-89) 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 § 721.72(a) through (f), (g)(1),
(3), and (5). For the purposes of § 721.72(e), the concentration is set at 1.0%. For purposes of §
721.72(g)(1), this substance may cause specific target organ toxicity. For purposes of §
721.72(g)(3), this substance may be toxic to aquatic life. Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System and Hazard Communication
Standard may be used.
(ii) Industrial, commercial, and consumer use. It is a significant new use to manufacture,
process, or use the substance in any manner that results in inhalation exposure. It is a significant
new use to manufacture, process, or use the substance in any manner that results in direct air
releases to the environment except during loading or unloading of transport containers.
(iii) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4),
where N=2.

(b) Specific requirements. The provisions of subpart A of this part apply to this section
except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in § 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 §
721.185 apply to this section.
§ 721.11844 Lignin, modified, reaction products with alkylamine by-products (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical
substance identified generically as lignin, modified, reaction products with alkylamine byproducts (PMN P-21-90) 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 § 721.63(a)(1) and (3), (b),
and (c). When determining which persons are reasonably likely to be exposed as required for §
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. For
purposes of § 721.63(b), the concentration is set at 1.0%.
(ii) Hazard communication. Requirements as specified in § 721.72(a) through (f), and
(g)(1), (3) and (5). For the purposes of § 721.72(e), the concentration is set at 1.0%. For purposes
of § 721.72(g)(1), this substance may cause specific target organ toxicity. For purposes of §
721.72(g)(3), this substance may be toxic to aquatic life. Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System and Hazard Communication
Standard may be used.
(iii) Industrial, commercial, and consumer use. It is a significant new use to manufacture,

process, or use the substance in any manner that results in inhalation exposure. It is a significant
new use to manufacture, process, or use the substance in any manner that results in direct air
releases to the environment except during loading or unloading of transport containers.
(iv) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4),
where N=12.
(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 § 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 §
721.185 apply to this section.
§ 721.11845 Sulfonium, triphenyl-, salt with fluoroalkyl 5-sulfobicyclo[2.2.1]heptane
carboxylate (1:1) (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical
substance identified generically as sulfonium, triphenyl-, salt with fluoroalkyl 5sulfobicyclo[2.2.1]heptane carboxylate (1:1) (PMN P-21-124) 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 § 721.63(a)(1), (2)(i) and
(iii), (3), and (c). When determining which persons are reasonably likely to be exposed as
required for § 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 § 721.72(a) through (d), (f),
(g)(1), (2)(i) through (iii), (v), (3)(i) and (ii), and (5). For purposes of § 721.72(g)(1), this
substance may cause: acute toxicity, skin irritation, serious eye damage, skin sensitization,
genetic toxicity, 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 §
721.80(f) and (t). It is a significant new use to use the substance other than as an onium salt that
generates strong or weak acid in lithography process. It is a significant new use to import the
substance other than in solution or in sealed containers weighing 5 kilograms or less. It is a
significant new use to process the substance in any way that generates 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 § 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 §
721.185 apply to this section.
§ 721.11846 Triazine-trione, tris(isocyanatoalkyl)-, polymer with substituted diisocyanato
alkylcarbomonocycle, hydro-hydroxypoly(oxyalkanediyl)and hydrohydroxypoly[oxy(alkyl-alkanediyl)], aliphatic alkyl amine-blocked (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical
substance identified generically as triazine-trione, tris(isocyanatoalkyl)-, polymer with
substituted diisocyanato alkylcarbomonocycle, hydro-hydroxypoly(oxyalkanediyl)and hydro-

hydroxypoly[oxy(alkyl-alkanediyl)], aliphatic alkyl amine-blocked (PMN P-21-137) is subject to
reporting under this section for the significant new uses described in paragraph (a)(2) of this
section. The requirements of this section do not apply to quantities of the substance after they
have been completely reacted or cured.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1) and (3), and
(c). When determining which persons are reasonably likely to be exposed as required for §
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 § 721.72(a) through (d), (f), and
(g)(1), (3) and (5). For purposes of § 721.72(g)(1), this substance may cause: acute toxicity, skin
corrosion, skin irritation, skin sensitization, serious eye damage, eye irritation, genetic toxicity,
reproductive toxicity, specific target organ toxicity, and respiratory irritation. For purposes of §
721.72(g)(3), this substance may be: toxic to aquatic life. Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System and Hazard Communication
Standard may be used.
(iii) Industrial, commercial, and consumer use. Requirements as specified in § 721.80(o).
It is a significant new use to manufacture, process, or use the substance in any manner that
results in inhalation exposure.
(iv) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4),
where N=15.
(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 § 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 §
721.185 apply to this section.
§ 721.11847 Lithium metal oxide (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical
substance identified generically as lithium metal oxide (PMN P-21-138) 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 § 721.63(a)(1), (3) through
(5), (b), and (c). When determining which persons are reasonably likely to be exposed as
required for § 721.63(a)(1) and (4), engineering control measures (e.g., enclosure or confinement
of the operation, general and local ventilation) or administrative control measures (e.g.,
workplace policies and procedures) shall be considered and implemented to prevent exposure,
where feasible. For purposes of § 721.63(a)(5), respirators must provide a National Institute for
Occupational Safety and Health (NIOSH) assigned protection factor (APF) of at least 1,000 if
the dust control capture and reduction rate is at less than 90% or at least 50 if the dust control
capture and reduction rate is at least 90%. For purposes of § 721.63(b), the concentration is set at
1.0%.
(ii) Hazard communication. Requirements as specified in § 721.72(a) through (f), (g)(1),
and (5). For the purposes of § 721.72(e) the concentration is set at 1.0%. For purposes of §
721.72(g)(1), this substance may cause: reproductive toxicity and specific target organ toxicity.
Alternative hazard and warning statements that meet the criteria of the Globally Harmonized
System and Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements as specified in §
721.80(f) and (o). It is a significant new use to use the substance other than in the manufacture of
batteries.
(iv) Disposal. Requirements as specified in § 721.85(a)(1) and (2), (b)(1) and (2), and

(c)(1) and (2).
(b) Specific requirements. The provisions of subpart A of this part apply to this section
except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (j)
are applicable to manufacturers, importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements. The provisions of §
721.185 apply to this section.
§ 721.11848 Soybean oil, oleic acid-high, epoxidized.
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical
substance identified as soybean oil, oleic acid-high, epoxidized (PMN P-21-140; CASRN
2410202-82-1) 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 § 721.63(a)(1) and (3), (b),
and (c). When determining which persons are reasonably likely to be exposed as required for §
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. For
purposes of § 721.63(b), the concentration is set at 0.1%.
(ii) Hazard communication. Requirements as specified in § 721.72(a) through (f), (g)(1),
(3), and (5). For purposes of § 721.72(e), the concentration is set at 0.1%. For purposes of §
721.72(g)(1), this substance may cause: skin irritation, eye irritation, respiratory sensitization,
carcinogenicity, reproductive toxicity, and specific target organ toxicity. For purposes of §
721.72(g)(3), this substance may be: toxic to aquatic life. Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System and Hazard Communication
Standard may be used.

(iii) Industrial, commercial, and consumer activities. It is a significant new use to use the
substance other than as a chemical intermediate to prepare acrylate-containing oil, which is
subsequently polymerized to prepare a viscosity modifier for asphalt. It is a significant new use
to manufacture, process, or use the substance in any manner that results in inhalation exposure.
(iv) Release to water. Requirements as specified in § 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 § 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 §
721.185 apply to this section.
§ 721.11849 Sulfonium, (halocarbomonocycle)diphenyl-, salt with 1-heterosubstituted-2methylalkyl trihalobenzoate (1:1) (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical
substance identified generically as sulfonium, (halocarbomonocycle)diphenyl-, salt with 1heterosubstituted-2-methylalkyl trihalobenzoate (1:1) (PMN P-21-180) 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 § 721.63(a)(1), (2)(i) and
(iii), (3), and (c). When determining which persons are reasonably likely to be exposed as
required for § 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 § 721.72(a) through (d), (f),
(g)(1), (2)(i) through (iii), (v), (3)(i) and (ii), and (5). For purposes of § 721.72(g)(1), this
substance may cause: acute toxicity, skin irritation, serious eye damage, skin sensitization,
genetic toxicity, 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 §
721.80(f), (k), and (t). It is a significant new use to import the substance other than in solution or
in sealed containers weighing 5 kilograms or less. It is a significant new use to process the
substance in any way that generates 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 § 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 §
721.185 apply to this section.
§ 721.11850 1,6-Disubstituted hexane (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical
substance identified generically as 1,6-disubstituted hexane (PMN P-21-199) 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 reacted or destroyed.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1) and (3), and

(c). When determining which persons are reasonably likely to be exposed as required for §
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 § 721.72(a) through (d), (f),
(g)(1), (3), and (5). For purposes of § 721.72(g)(1), this substance may cause: acute toxicity, skin
irritation, eye irritation, respiratory sensitization, skin sensitization, genetic toxicity,
carcinogenicity, reproductive toxicity, and specific target organ toxicity. For the purposes of §
721.72(g)(3), this substance may be: toxic to aquatic life. Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System and Hazard Communication
Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements as specified in §
721.80(o). It is a significant new use to manufacture, process, or use the substance in any manner
that results in inhalation exposures.
(iv) Disposal. It is a significant new use to dispose of the substance other than by
hazardous waste incineration.
(v) Release to water. Requirements as specified in § 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 § 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 §
721.185 apply to this section.
§ 721.11851 1,3-Propanediaminium, 2-hydroxy-N1,N1,N1,N3,N3-pentamethyl-N3tetradecyl-, chloride (1:2); 1,3-Propanediaminium, N1-hexadecyl-2-hydroxyN1,N1,N3,N3,N3-pentamethyl-, chloride (1:2); 1,3-Propanediaminium, 2-hydroxy-

N1,N1,N1,N3,N3-pentamethyl-N3-octadecyl-, chloride (1:2); 1,3-Propanediaminium, 2hydroxy-N1,N1,N1,N3,N3-pentamethyl-N3-octadecen-1-yl, chloride (1:2).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical
substance identified as 1,3-propanediaminium, 2-hydroxy-N1,N1,N1,N3,N3-pentamethyl-N3tetradecyl-, chloride (1:2); 1,3-propanediaminium, N1-hexadecyl-2-hydroxy-N1,N1,N3,N3,N3pentamethyl-, chloride (1:2); 1,3-propanediaminium, 2-hydroxy-N1,N1,N1,N3,N3-pentamethylN3-octadecyl-, chloride (1:2); 1,3-propanediaminium, 2-hydroxy-N1,N1,N1,N3,N3pentamethyl-N3-octadecen-1-yl, chloride (1:2) (PMN P-21-201; CASRNs 1622255-87-1; 6356076-9; 197862-16-1; and 2748681-38-9) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section. The requirements of this
section do not apply to quantities of the substance after they have been completely reacted or
cured.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1) and (3), (b),
and (c). When determining which persons are reasonably likely to be exposed as required for §
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. For
purposes of § 721.63(b), the concentration is set at 0.1%.
(ii) Hazard communication. Requirements as specified in § 721.72(a) through (f), (g)(1),
(3), and (5). For purposes of § 721.72(e), the concentration is set at 1.0%. For purposes of §
721.72(g)(1), this substance may cause: acute toxicity, skin corrosion, skin irritation, serious eye
damage, eye irritation, reproductive toxicity, and specific target organ toxicity. For purposes of §
721.72(g)(3), this substance may be: toxic to aquatic life. Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System and Hazard Communication
Standard may be used.

(iii) Industrial, commercial, and consumer use. Requirements as specified in § 721.80(o).
It is a significant new use to manufacture, process, or use the substance in any manner or method
that results in inhalation exposure.
(iv) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4),
where N=21.
(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 § 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 §
721.185 apply to this section.
§ 721.11852 Alkanes, branched and linear (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical
substance identified generically as alkanes, branched and linear (PMN P-21-206) 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 a fuel.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1) and (3), (b)
and (c). When determining which persons are reasonably likely to be exposed as required for §
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. For
purposes of § 721.63(b), the concentration is set at 0.1%.
(ii) Hazard communication. Requirements as specified in § 721.72(a).
(iii) Industrial, commercial, and consumer use. It is a significant new use to manufacture,

process, or use the substance other than as a fuel, fuel additive, or regulated blendstock subject to
40 CFR parts 79 or 1090, including as a component of gasoline or ethanol base fuel (E85).
(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 § 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 §
721.185 apply to this section.
§ 721.11853 Polyester with 1,4-benzenedicarboxylic acid, 1,4- dimethyl 1,4benzenedicarboxylate, 2,2-dimethyl-1,3-propanediol, dodecanedioic acid, 1,2-ethanediol,
aliphatic polyester, 3- hydroxy-2,2-dimethylpropyl 3-hydroxy-2,2-dimethylpropanoate, 1,3isobenzofurandione and 1,1'-methylenebis[isocyanatobenzene] (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical
substance identified generically as polyester with 1,4-benzenedicarboxylic acid, 1,4- dimethyl
1,4-benzenedicarboxylate, 2,2-dimethyl-1,3-propanediol, dodecanedioic acid, 1,2-ethanediol,
aliphatic polyester, 3- hydroxy-2,2-dimethylpropyl 3-hydroxy-2,2-dimethylpropanoate, 1,3isobenzofurandione and 1,1'-methylenebis[isocyanatobenzene] (PMN P-22-29) is subject to
reporting under this section for the significant new uses described in paragraph (a)(2) of this
section. The requirements of this section do not apply to quantities of the substance after they
have been completely reacted or cured.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1) and (3), and
(c). When determining which persons are reasonably likely to be exposed as required for §
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 § 721.72(a) through (d), (f),
(g)(1), and (5). For purposes of § 721.72(g)(1), this substance may cause: skin irritation, eye
irritation, respiratory sensitization, skin sensitization, and specific target organ toxicity.
Alternative hazard and warning statements that meet the criteria of the Globally Harmonized
System and Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer use. Requirements as specified in § 721.80(o).
It is a significant new use to manufacture, process, or use the substance in any manner that
results in inhalation exposure.
(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 § 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 §
721.185 apply to this section.
§ 721.11854 Polyester with 1,4-benzenedicarboxylic acid, 2,2-dimethyl-1,3-propanediol,
dodecanedioic acid, 1,2-ethanediol, aliphatic polyester, 3-hydroxy-2,2-dimethylpropyl 3hydroxy-2,2-dimethylpropanoate, 1,3-isobenzofurandione and 1,1'-methylenebis[4isocyanatobenzene] (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical
substance identified generically as polyester with 1,4-benzenedicarboxylic acid, 2,2-dimethyl1,3-propanediol, dodecanedioic acid, 1,2-ethanediol, aliphatic polyester, 3-hydroxy-2,2dimethylpropyl 3- hydroxy-2,2-dimethylpropanoate, 1,3-isobenzofurandione and 1,1'methylenebis[4- isocyanatobenzene] (PMN P-22-30) is subject to reporting under this section for
the significant new uses described in paragraph (a)(2) of this section. The requirements of this
section do not apply to quantities of the substance after they have been completely reacted or
cured.

(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1) and (3), and
(c). When determining which persons are reasonably likely to be exposed as required for §
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 § 721.72(a) through (d), (f),
(g)(1), and (5). For purposes of § 721.72(g)(1), this substance may cause: skin irritation, eye
irritation, respiratory sensitization, skin sensitization, and specific target organ toxicity.
Alternative hazard and warning statements that meet the criteria of the Globally Harmonized
System and Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer use. Requirements as specified in § 721.80(o).
It is a significant new use to manufacture, process, or use the substance in any manner that
results in inhalation exposure.
(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 § 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 §
721.185 apply to this section.
§ 721.11855 Polyester with 1,4-benzenedicarboxylic acid, 2,2-dimethyl-1,3-propanediol,
dodecanedioic acid, 1,2-ethanediol, aliphatic polyester, 3-hydroxy-2,2-dimethylpropyl 3hydroxy-2,2-dimethylpropanoate, 1,3-isobenzofurandione and 1,1'methylenebis[isocyanatobenzene] (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical
substance identified generically as polyester with 1,4-benzenedicarboxylic acid, 2,2-dimethyl-

1,3-propanediol, dodecanedioic acid, 1,2-ethanediol, aliphatic polyester, 3-hydroxy-2,2dimethylpropyl 3-hydroxy-2,2-dimethylpropanoate, 1,3-isobenzofurandione and 1,1'methylenebis[isocyanatobenzene] (PMN P-22-31) is subject to reporting under this section for
the significant new uses described in paragraph (a)(2) of this section. The requirements of this
section do not apply to quantities of the substance after they have been completely reacted or
cured.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1) and (3), and
(c). When determining which persons are reasonably likely to be exposed as required for §
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 § 721.72(a) through (d), (f),
(g)(1), and (5). For purposes of § 721.72(g)(1), this substance may cause: skin irritation, eye
irritation, respiratory sensitization, skin sensitization, and specific target organ toxicity.
Alternative hazard and warning statements that meet the criteria of the Globally Harmonized
System and Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer use. Requirements as specified in § 721.80(o).
It is a significant new use to manufacture, process, or use the substance in any manner that
results in inhalation exposure.
(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 § 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 §
721.185 apply to this section.

§ 721.11856 Aromatic sulfonium tricyclo fluoroalkyl sulfonic acid salt (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical
substance identified generically as aromatic sulfonium tricyclo fluoroalkyl sulfonic acid salt
(PMN P-22-55) 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 § 721.63(a)(1), (2)(i) and
(iii), (3), and (c). When determining which persons are reasonably likely to be exposed as
required for § 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 § 721.72(a) through (d), (f),
(g)(1), (2)(i) through (iii), (v), (3)(i) and (ii), and (5). For purposes of § 721.72(g)(1), this
substance may cause: skin irritation, acute toxicity, skin corrosion, skin sensitization, eye
irritation, serious eye damage, specific target organ toxicity, genetic toxicity, and reproductive
(developmental) 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 §
721.80(f) and (t). It is a significant new use to use the substance other than as a photoacid
generator. 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 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 § 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 §
721.185 apply to this section.
§ 721.11857 Fluoroheteroacid, metal salt (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical
substance identified generically as fluoroheteroacid, metal salt (PMN P-22-69) is subject to
reporting under this section for the significant new uses described in paragraph (a)(2) of this
section. The requirements of this section do not apply to quantities of the substance after they
have been incorporated into an article.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (3) through
(5), and (c). When determining which persons are reasonably likely to be exposed as required for
§ 721.63(a)(1) and (4), engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control measures (e.g., workplace
policies and procedures) shall be considered and implemented to prevent exposure, where
feasible. For purposes of § 721.63(a)(5), respirators must provide a National Institute for
Occupational Safety and Health (NIOSH) assigned protection factor (APF) of at least 50.
(ii) Hazard communication. Requirements as specified in § 721.72(a) through (d), (f),
(g)(1), (3), and (5). For purposes of § 721.72(g)(1), this substance may cause: acute toxicity, skin
corrosion, serious eye damage, skin sensitization, reproductive toxicity, and specific target organ
toxicity. For purposes of § 721.72(g)(3), this substance may be: toxic to aquatic life. Alternative
hazard and warning statements that meet the criteria of the Globally Harmonized System and

Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements as specified in §
721.80(o).
(iv) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4),
where N=380.
(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 § 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 §
721.185 apply to this section.
§ 721.11858 Hydrocarbons, C5-10.
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical
substance identified as hydrocarbons, C5-10 (PMN P-22-147; CASRN 2779559-23-6) 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 gasoline.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1) and (3), (b),
and (c). When determining which persons are reasonably likely to be exposed as required for §
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. For
purposes of § 721.63(b), the concentration is set at 0.1%.
(ii) Hazard communication. Requirements as specified in § 721.72(a).
(iii) Industrial, commercial, and consumer use. Requirements as specified in § 721.80(f).

It is a significant new use to import, process, or use the substance other than as a feedstock for
gasoline containing no more than 64% of the substance where the imported gasoline mixture is
regulated under applicable EPA regulations for fuels, fuel additives, and regulated blendstocks
(40 CFR part 1090), fuel additives, and regulated blendstocks (40 CFR part 1090), registration of
fuels and fuel additives (40 CFR part 79).
(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 § 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 §
721.185 apply to this section.
§ 721.11859 Sulfonium, tricarbocyclic-, alpha, alpha, beta, beta-polyhalopolyhydroheteropolycyclic-5-alkanesulfonate (1:1) (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical
substance identified generically as sulfonium, tricarbocyclic-, alpha, alpha, beta, betapolyhalopolyhydro-heteropolycyclic-5-alkanesulfonate (1:1) (PMN P-22-150) is subject to
reporting under this section for the significant new uses described in paragraph (a)(2) of this
section. The requirements of this section do not apply to quantities of the substance after they
have been 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 § 721.63(a)(1), (2)(i) and
(iii), (3), and (c). When determining which persons are reasonably likely to be exposed as
required for § 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 § 721.72(a) through (d), (f),
(g)(1), (2)(i) through (iii), (v), (3)(i) and (ii), and (5). For purposes of § 721.72(g)(1), this
substance may cause: acute toxicity, skin irritation, serious eye damage, skin sensitization,
genetic toxicity, 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 §
721.80(f), (k), and (t). It is a significant new use to import the substance other than in solution or
in sealed containers weighing 5 kilograms or less. It is a significant new use to process the
substance in any way that generates dust, mist, or aerosol in a non-enclosed process. It is a
significant new use to manufacture the substance longer than 9 months.
(b) Specific requirements. The provisions of subpart A of this part apply to this section
except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in § 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 §
721.185 apply to this section.
§ 721.11860 Sulfonium, tricarbocyclic-, 2-heteroatom-substituted-4alkylcarbomonocyclecarboxylate (1:1) (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical
substance identified generically as sulfonium, tricarbocyclic-, 2-heteroatom-substituted-4alkylcarbomonocyclecarboxylate (1:1) (PMN P-22-152) is subject to reporting under this section
for the significant new uses described in paragraph (a)(2) of this section. The requirements of
this section do not apply to quantities of the substance after they have been 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 § 721.63(a)(1), (2)(i) and
(iii), (3), and (c). When determining which persons are reasonably likely to be exposed as
required for § 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 § 721.72(a) through (d), (f),
(g)(1), (2)(i) through (iii), (v), (3)(i) and (ii), and (5). For purposes of § 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 §
721.80(f), (k), and (t). It is a significant new use to import the substance other than in solution or
in sealed containers weighing 5 kilograms or less. It is a significant new use to process the
substance in any way that generates dust, mist, or aerosol in a non-enclosed process. It is a
significant new use to manufacture the substance longer than 9 months.
(b) Specific requirements. The provisions of subpart A of this part apply to this section
except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in § 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 §
721.185 apply to this section.

§ 721.11861 Sulfonium, tricarbocyclic-, salt with [polyhydro-2-alkyl-5-(polyhalo-2heteroalkyl)- alkano-1,3-hetropolycyclic]alkyl polyhaloaryl ester (1:1) (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical
substance identified generically as sulfonium, tricarbocyclic-, salt with [polyhydro-2-alkyl-5(polyhalo-2-heteroalkyl)- alkano-1,3-hetropolycyclic]alkyl polyhaloaryl ester (1:1) (PMN P-22161) 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 § 721.63(a)(1), (2)(i) and
(iii), (3), and (c). When determining which persons are reasonably likely to be exposed as
required for § 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 § 721.72(a) through (d), (f),
(g)(1), (2)(i) through (iii), (v), (3)(i) and (ii), and (5). For purposes of § 721.72(g)(1), this
substance may cause: acute toxicity, skin irritation, serious eye damage, skin sensitization,
genetic toxicity, reproductive toxicity, carcinogenicity, and specific target organ toxicity.
Alternative hazard and warning statements that meet the criteria of the Globally Harmonized
System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements as specified in §
721.80(f), (k), and (t). It is a significant new use to import the substance other than in solution or
in sealed containers weighing 5 kilograms or less. It is a significant new use to process the

substance in any way that generates dust, mist, or aerosol in a non-enclosed process. It is a
significant new use to manufacture the substance longer than 9 months.
(b) Specific requirements. The provisions of subpart A of this part apply to this section
except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in § 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 §
721.185 apply to this section.
§ 721.11862 Sulfonium, tricarbocyclic-, alpha, alpha, beta, beta-polyhalopolyhydroheteropolycyclic-5-alkanesulfonate (1:1) (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical
substance identified generically as sulfonium, tricarbocyclic-, alpha, alpha, beta, betapolyhalopolyhydro-heteropolycyclic-5-alkanesulfonate (1:1) (PMN P-22-177) 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 § 721.63(a)(1), (2)(i) and
(iii), (3), and (c). When determining which persons are reasonably likely to be exposed as
required for § 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 § 721.72(a) through (d), (f),

(g)(1), (2)(i) through (iii), (v), (3)(i) and (ii), and (5). For purposes of § 721.72(g)(1), this
substance may cause: acute toxicity, skin irritation, serious eye damage, skin sensitization,
genetic toxicity, 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 §
721.80(f), (k), and (t). It is a significant new use to import the substance other than in solution or
in sealed containers weighing 5 kilograms or less. It is a significant new use to process the
substance in any way that generates dust, mist, or aerosol in a non-enclosed process. It is a
significant new use to manufacture the substance longer than 9 months.
(b) Specific requirements. The provisions of subpart A of this part apply to this section
except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in § 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 §
721.185 apply to this section.

[FR Doc. 2024-12620 Filed: 6/10/2024 8:45 am; Publication Date: 6/11/2024]