[Federal Register Volume 89, Number 113 (Tuesday, June 11, 2024)]
[Proposed Rules]
[Pages 49770-49796]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-12620]



[[Page 49769]]

Vol. 89

Tuesday,

No. 113

June 11, 2024

Part V





Environmental Protection Agency





-----------------------------------------------------------------------





40 CFR Part 721





Significant New Use Rules on Certain Chemical Substances (23-3.5e); 
Proposed Rule

  Federal Register / Vol. 89 , No. 113 / Tuesday, June 11, 2024 / 
Proposed Rules  

[[Page 49770]]


-----------------------------------------------------------------------

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 July 11, 2024.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-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: 
[email protected].
    For general information: The TSCA-Hotline, ABVI-Goodwill, 422 South 
Clinton Ave., Rochester, NY 14620; telephone number: (202) 554-1404; 
email address: [email protected].

SUPPLEMENTARY INFORMATION:

I. Executive Summary

A. What is the Agency's authority for taking this action?

    TSCA section 5(a)(2) (15 U.S.C. 2604(a)(2)) authorizes EPA to 
determine that a use of a chemical substance is a ``significant new 
use.'' EPA must make this determination by rule after considering all 
relevant factors, including the factors in TSCA section 5(a)(2) (see 
also the discussion in Unit II.).

B. What action is the Agency taking?

    EPA is proposing SNURs for 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 July 11, 2024 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

[[Page 49771]]

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-toxic-substances-control-act-tsca.

A. Significant New Use Determination Factors

    TSCA section 5(a)(2) states that EPA's determination that a use of 
a chemical substance is a significant new use must be made after 
consideration of all relevant factors, including:
     The projected volume of manufacturing and processing of a 
chemical substance.
     The extent to which a use changes the type or form of 
exposure of human beings or the environment to a chemical substance.
     The extent to which a use increases the magnitude and 
duration of exposure of human beings or the environment to a chemical 
substance.
     The reasonably anticipated manner and methods of 
manufacturing, processing, distribution in commerce, and disposal of a 
chemical substance.
    In determining what would constitute a significant new use for the 
chemical substances that are the subject of these SNURs, EPA considered 
relevant 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.

[[Page 49772]]

    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-under-toxic-substances-control-act-tsca.
2. Development and Submission of Information
    EPA recognizes that TSCA section 5 does not require development of 
any particular new information (e.g., generating test data) before 
submission of a SNUN. There is an exception: If a person is required to 
submit information for a chemical substance pursuant to a rule, order 
or consent agreement under TSCA section 4, then TSCA section 5(b)(1)(A) 
requires such information to be submitted to EPA at the time of 
submission of the SNUN.
    In the absence of a rule, TSCA Order, or consent agreement under 
TSCA section 4 covering the chemical substance, persons are required 
only to submit information in their possession or control and to 
describe any other information known to or reasonably ascertainable by 
them (see 40 CFR 720.50). However, upon review of PMNs and SNUNs, the 
Agency has the authority to require appropriate testing. To assist with 
EPA's analysis of the SNUN, submitters are encouraged, but not 
required, to provide the potentially useful information identified for 
the chemical substance in Unit III.C.
    EPA strongly encourages persons, before performing any testing, to 
consult with the Agency pertaining to protocol selection. Furthermore, 
pursuant to TSCA section 4(h), which pertains to reduction of testing 
in vertebrate animals, EPA encourages consultation with the Agency on 
the use of alternative test methods and strategies (also called New 
Approach Methodologies, or NAMs), if available, to generate the 
recommended test data. EPA encourages dialog with Agency 
representatives to help determine how best the submitter can meet both 
the data needs and the objective of TSCA section 4(h). For more 
information on alternative test methods and strategies to reduce 
vertebrate animal testing, visit https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/alternative-test-methods-and-strategies-reduce.
    The potentially useful information described in Unit III.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

[[Page 49773]]

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 June 11, 2024 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-alkyl-alkanoate, 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

[[Page 49774]]

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 -4,7-methano-1,3-benzodioxole-5-alkanesulfonate (1:1) 
(generic) (P-21-48), 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) (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-21-131), 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);

[[Page 49775]]

     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.-(1-methylethoxy)-, 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

[[Page 49776]]

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 by-products (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-

[[Page 49777]]

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(alkyl-alkanediyl)], 
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-of-entry 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),

[[Page 49778]]

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 acrylate-containing 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-2-methylalkyl 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:

[[Page 49779]]

     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-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-N3-octadecyl-, 
chloride (1:2); 1,3-Propanediaminium, 2-hydroxy-N1,N1,N1,N3,N3-
pentamethyl-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

[[Page 49780]]

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 1,4-benzenedicarboxylate, 2,2-dimethyl-1,3-propanediol, 
dodecanedioic acid, 1,2-ethanediol, aliphatic polyester, 3- hydroxy-
2,2-dimethylpropyl 3-hydroxy-2,2-dimethylpropanoate, 1,3-
isobenzofurandione and 1,1'-methylenebis[isocyanatobenzene] (generic) 
(P-22-29), Polyester with 1,4-benzenedicarboxylic acid, 2,2-dimethyl-
1,3-propanediol, dodecanedioic acid, 1,2-ethanediol, aliphatic 
polyester, 3-hydroxy-2,2-dimethylpropyl 3- hydroxy-2,2-
dimethylpropanoate, 1,3-isobenzofurandione and 1,1'-methylenebis[4- 
isocyanatobenzene] (generic) (P-22-30), and Polyester with 1,4-
benzenedicarboxylic acid, 2,2-dimethyl-1,3-propanediol, dodecanedioic 
acid, 1,2-ethanediol, aliphatic polyester, 3-hydroxy-2,2-dimethylpropyl 
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

[[Page 49781]]

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

[[Page 49782]]

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-polyhalopolyhydro-heteropolycyclic-5-alkanesulfonate (1:1) 
(generic) (P-22-150), Sulfonium, tricarbocyclic-, 2-heteroatom-
substituted-4-alkylcarbomonocyclecarboxylate (1:1) (generic) (P-22-
152), Sulfonium, tricarbocyclic-, salt with [polyhydro-2-alkyl-5-
(polyhalo-2-heteroalkyl)- alkano-1,3-hetropolycyclic]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 P-22-150, 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

[[Page 49783]]

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) (FRL-
5597-1), the Agency presented its general determination that SNURs are 
not expected to have a significant economic impact on a substantial 
number of small entities, which was provided to the Chief Counsel for 
Advocacy of the Small Business Administration.

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.

[[Page 49784]]

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

0
1. The authority citation for part 721 continues to read as follows:

    Authority: 15 U.S.C. 2604, 2607, and 2625(c).

0
2. Add Sec. Sec.  721.11829 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- 1,3-benzodioxole-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(alkyl-
alkanediyl)], 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-2-methylalkyl 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-N3-
octadecyl-, chloride (1:2); 1,3-Propanediaminium, 2-hydroxy-
N1,N1,N1,N3,N3-pentamethyl-N3-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, 3- hydroxy-
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 3- hydroxy-2,2-
dimethylpropanoate, 1,3-isobenzofurandione and 1,1'-methylenebis[4- 
isocyanatobenzene] (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 3-hydroxy-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-
polyhalopolyhydro-heteropolycyclic-5-alkanesulfonate (1:1) 
(generic).
721.11860 Sulfonium, tricarbocyclic-, 2-heteroatom-substituted-4-
alkylcarbomonocyclecarboxylate (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-
polyhalopolyhydro-heteropolycyclic-5-alkanesulfonate (1:1) 
(generic).
* * * * *


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).

    (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 alkyl-
substituted 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 Sec.  
721.63(a)(1), (3) through (5), (b), and (c). When determining which 
persons are reasonably likely to be exposed as required for Sec.  
721.63(a)(1) and (4), engineering control measures (e.g., enclosure or 
confinement of the operation, general and local ventilation) or 
administrative control measures (e.g., workplace policies and 
procedures) shall be considered and implemented to prevent exposure, 
where feasible. For purposes of Sec.  721.63(a)(5), respirators must 
provide a National Institute for Occupational Safety and Health (NIOSH) 
assigned protection factor (APF) of at least 10. For purposes of Sec.  
721.63(b), the concentration is set at 1.0%.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (f), (g)(1), (3), and (5). For purposes of Sec.  
721.72(e), the concentration is set at 1.0%. For purposes of Sec.  
721.72(g)(1), this

[[Page 49785]]

substance may cause: skin corrosion and eye irritation. For purposes of 
Sec.  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 Sec.  
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 Sec.  
721.125(a) through (i), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11830  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, 2-oxepanone 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 Sec.  
721.63(a)(1), (3) through (5), (b), and (c). When determining which 
persons are reasonably likely to be exposed as required for Sec.  
721.63(a)(1) and (4), engineering control measures (e.g., enclosure or 
confinement of the operation, general and local ventilation) or 
administrative control measures (e.g., workplace policies and 
procedures) shall be considered and implemented to prevent exposure, 
where feasible. For purposes of Sec.  721.63(a)(5), respirators must 
provide a National Institute for Occupational Safety and Health (NIOSH) 
assigned protection factor (APF) of at least 50 during non-spray 
applications or 10,000 during spray applications. For purposes of Sec.  
721.63(b), the concentration is set at 1.0%.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (f), (g)(1), (3), and (5). For purposes of Sec.  
721.72(e), the concentration is set at 1.0%. For purposes of Sec.  
721.72(g)(1), this substance may cause: skin irritation, eye 
irritation, and specific target organ toxicity. For purposes of Sec.  
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 Sec.  721.80(o).
    (iv) Release to water. Requirements as specified in Sec.  
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 Sec.  
721.125(a) through (i), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11831  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 Sec.  
721.63(a)(1) and (3), (b), and (c). When determining which persons are 
reasonably likely to be exposed as required for Sec.  721.63(a)(1), 
engineering control measures (e.g., enclosure or confinement of the 
operation, general and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures) shall be considered 
and implemented to prevent exposure, where feasible. For purposes of 
Sec.  721.63(b), the concentration is set at 1.0%.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (f), (g)(1), (3), and (5). For purposes of Sec.  
721.72(e), the concentration is set at 1.0%. For purposes of Sec.  
721.72(g)(1), this substance may cause: specific target organ toxicity. 
For purposes of Sec.  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 Sec.  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 Sec.  
721.125(a) through (i) are applicable to manufacturers, importers, and 
processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11832  Sulfonium, tricarbocyclic-, polyfluoropolyhydro-2,2-
dicarbocyclic -4,7-methano- 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-2,2-dicarbocyclic -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 Sec.  
721.63(a)(1), (2)(i) and (iii), (3), and (c). When determining which 
persons are reasonably likely to be exposed as required for Sec.  
721.63(a)(1), engineering

[[Page 49786]]

control measures (e.g., enclosure or confinement of the operation, 
general and local ventilation) or administrative control measures 
(e.g., workplace policies and procedures) shall be considered and 
implemented to prevent exposure, where feasible.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (f), (g)(1), (2)(i) through (iii), (v), (3)(i) 
and (ii), and (5). For purposes of Sec.  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 Sec.  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 Sec.  
721.125(a) through (i) are applicable to manufacturers, importers, and 
processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11833  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-5-alkanesulfonate (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 Sec.  
721.63(a)(1), (2)(i) and (iii), (3), and (c). When determining which 
persons are reasonably likely to be exposed as required for Sec.  
721.63(a)(1), engineering control measures (e.g., enclosure or 
confinement of the operation, general and local ventilation) or 
administrative control measures (e.g., workplace policies and 
procedures) shall be considered and implemented to prevent exposure, 
where feasible.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (f), (g)(1), (2)(i) through (iii), (v), (3)(i) 
and (ii), and (5). For purposes of Sec.  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 Sec.  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 Sec.  
721.125(a) through (i) are applicable to manufacturers, importers, and 
processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11834  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-5-alkanesulfonate (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 Sec.  
721.63(a)(1), (2)(i) and (iii), (3), and (c). When determining which 
persons are reasonably likely to be exposed as required for Sec.  
721.63(a)(1), engineering control measures (e.g., enclosure or 
confinement of the operation, general and local ventilation) or 
administrative control measures (e.g., workplace policies and 
procedures) shall be considered and implemented to prevent exposure, 
where feasible.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (f), (g)(1), (2)(i) through (iii), (v), (3)(i) 
and (ii), and (5). For purposes of Sec.  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 Sec.  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 Sec.  
721.125(a) through (i) are applicable to manufacturers, importers, and 
processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

[[Page 49787]]

Sec.  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-5-alkanesulfonate (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 Sec.  
721.63(a)(1), (2)(i) and (iii), (3), and (c). When determining which 
persons are reasonably likely to be exposed as required for Sec.  
721.63(a)(1), engineering control measures (e.g., enclosure or 
confinement of the operation, general and local ventilation) or 
administrative control measures (e.g., workplace policies and 
procedures) shall be considered and implemented to prevent exposure, 
where feasible.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (f), (g)(1), (2)(i) through (iii), (v), (3)(i) 
and (ii), and (5). For purposes of Sec.  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 Sec.  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 Sec.  
721.125(a) through (i) are applicable to manufacturers, importers, and 
processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11836  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 Sec.  
721.63(a)(1), (2)(i) and (iii), (3), and (c). When determining which 
persons are reasonably likely to be exposed as required for Sec.  
721.63(a)(1), engineering control measures (e.g., enclosure or 
confinement of the operation, general and local ventilation) or 
administrative control measures (e.g., workplace policies and 
procedures) shall be considered and implemented to prevent exposure, 
where feasible.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (f), (g)(1), (2)(i) through (iii), (v), (3)(i) 
and (ii), and (5). For purposes of Sec.  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 Sec.  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 Sec.  
721.125(a) through (i) are applicable to manufacturers, importers, and 
processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11837  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 Sec.  
721.63(a)(1), (2)(i) and (iii), (3), and (c). When determining which 
persons are reasonably likely to be exposed as required for Sec.  
721.63(a)(1), engineering control measures (e.g., enclosure or 
confinement of the operation, general and local ventilation) or 
administrative control measures (e.g., workplace policies and 
procedures) shall be considered and implemented to prevent exposure, 
where feasible.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (f), (g)(1), (2)(i) through (iii), (v), (3)(i) 
and (ii), and (5). For purposes of Sec.  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

[[Page 49788]]

System and OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f), (k), and (t). It is a significant new 
use to import the substance other than in solution 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 Sec.  
721.125(a) through (i) are applicable to manufacturers, importers, and 
processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11838   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 Sec.  
721.63(a)(1), (3) through (5), (b), and (c). When determining which 
persons are reasonably likely to be exposed as required for Sec.  
721.63(a)(1) and (a)(4), engineering control measures (e.g., enclosure 
or confinement of the operation, general and local ventilation) or 
administrative control measures (e.g., workplace policies and 
procedures) shall be considered and implemented to prevent exposure, 
where feasible. For purposes of Sec.  721.63(a)(5), respirators must 
provide a National Institute for Occupational Safety and Health (NIOSH) 
assigned protection factor (APF) of at least 10. For purposes of Sec.  
721.63(b), the concentration is set at 1.0%.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (f), (g)(1), and (5). For purposes of Sec.  
721.72(e), the concentration is set at 1.0%. For purposes of Sec.  
721.72(g)(1), this substance may cause: 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 Sec.  
721.125(a) through (i) are applicable to manufacturers, importers, and 
processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11839  Poly[oxy(methyl-1,2-ethandiyl)], .alpha.-
(dithiocarboxy)-.omega.-(1-methylethoxy)-, 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.-(1-methylethoxy)-, 
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 Sec.  
721.63(a)(1), (3) through (5), (b), and (c). When determining which 
persons are reasonably likely to be exposed as required for Sec.  
721.63(a)(1) and (a)(4), engineering control measures (e.g., enclosure 
or confinement of the operation, general and local ventilation) or 
administrative control measures (e.g., workplace policies and 
procedures) shall be considered and implemented to prevent exposure, 
where feasible. For purposes of Sec.  721.63(a)(5), respirators must 
provide a National Institute for Occupational Safety and Health (NIOSH) 
assigned protection factor (APF) of at least 10. For purposes of Sec.  
721.63(b), the concentration is set at 1.0%.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (f), (g)(1), (3), and (5). For the purposes of Sec.  
721.72(e), the concentration is set at 1.0%. For purposes of Sec.  
721.72(g)(1), this substance may cause skin irritation, eye irritation, 
reproductive toxicity, and specific target organ toxicity. For purposes 
of Sec.  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 Sec.  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 Sec.  
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 Sec.  
721.125(a) through (i), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11840  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 Sec.  
721.63(a)(1), (3) through (5), (b), and (c). When determining which 
persons are reasonably likely to be exposed as required for Sec.  
721.63(a)(1) and (a)(4), engineering control measures (e.g., enclosure 
or confinement of the operation, general and local ventilation) or 
administrative control measures (e.g., workplace policies and 
procedures) shall be considered and implemented to prevent exposure, 
where feasible. For purposes of Sec.  721.63(a)(5), respirators must 
provide a National Institute for Occupational Safety and Health (NIOSH) 
assigned protection factor (APF) of at least 10. For purposes of Sec.  
721.63(b), the concentration is set at 1.0%.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a)

[[Page 49789]]

through (f), (g)(1), (3), and (5). For the purposes of Sec.  721.72(e), 
the concentration is set at 1.0%. For purposes of Sec.  721.72(g)(1), 
this substance may cause skin irritation, eye irritation, reproductive 
toxicity, and specific target organ toxicity. For purposes of Sec.  
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 Sec.  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 Sec.  
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 Sec.  
721.125(a) through (i), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11841  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 Sec.  
721.63(a)(1), (3), (b), and (c). When determining which persons are 
reasonably likely to be exposed as required for Sec.  721.63(a)(1), 
engineering control measures (e.g., enclosure or confinement of the 
operation, general and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures) shall be considered 
and implemented to prevent exposure, where feasible. For purposes of 
Sec.  721.63(b), the concentration is set at 1.0%.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (f), (g)(1), (3), and (5). For the purposes of Sec.  
721.72(e) the concentration is set at 1.0%. For purposes of Sec.  
721.72(g)(1), this substance may cause: reproductive toxicity and 
specific target organ toxicity. For the purposes of Sec.  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 Sec.  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 Sec.  
721.90(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11842  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)ethyl-terminated (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 Sec.  
721.63(a)(1), (3), and (c). When determining which persons are 
reasonably likely to be exposed as required for Sec.  721.63(a)(1), 
engineering control measures (e.g., enclosure or confinement of the 
operation, general and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures) shall be considered 
and implemented to prevent exposure, where feasible.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (f), (g)(1), and (5). For purposes of Sec.  
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 Sec.  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 Sec.  
721.90(a)(1, (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11843  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 by-products, 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 Sec.  
721.72(a) through (f), (g)(1), (3), and (5). For the purposes of Sec.  
721.72(e), the concentration is set at 1.0%. For purposes of Sec.  
721.72(g)(1), this substance may cause specific target organ toxicity. 
For purposes of Sec.  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.

[[Page 49790]]

    (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 Sec.  
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 Sec.  
721.125(a) through (c), (f) through (i), and (k) are applicable to 
manufacturers, importers, and processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11844   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 by-products (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 Sec.  
721.63(a)(1) and (3), (b), and (c). When determining which persons are 
reasonably likely to be exposed as required for Sec.  721.63(a)(1), 
engineering control measures (e.g., enclosure or confinement of the 
operation, general and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures) shall be considered 
and implemented to prevent exposure, where feasible. For purposes of 
Sec.  721.63(b), the concentration is set at 1.0%.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (f), and (g)(1), (3) and (5). For the purposes of 
Sec.  721.72(e), the concentration is set at 1.0%. For purposes of 
Sec.  721.72(g)(1), this substance may cause specific target organ 
toxicity. For purposes of Sec.  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 Sec.  
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 Sec.  
721.125(a) through (i), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11845  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 5-
sulfobicyclo[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 Sec.  
721.63(a)(1), (2)(i) and (iii), (3), and (c). When determining which 
persons are reasonably likely to be exposed as required for Sec.  
721.63(a)(1), engineering control measures (e.g., enclosure or 
confinement of the operation, general and local ventilation) or 
administrative control measures (e.g., workplace policies and 
procedures) shall be considered and implemented to prevent exposure, 
where feasible.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (f), (g)(1), (2)(i) through (iii), (v), (3)(i) 
and (ii), and (5). For purposes of Sec.  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 Sec.  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 Sec.  
721.125(a) through (i) are applicable to manufacturers, importers, and 
processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11846  Triazine-trione, tris(isocyanatoalkyl)-, polymer with 
substituted diisocyanato alkylcarbomonocycle, hydro-
hydroxypoly(oxyalkanediyl) and hydro-hydroxypoly[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 Sec.  
721.63(a)(1) and (3), and (c). When determining which persons are 
reasonably likely to be exposed as

[[Page 49791]]

required for Sec.  721.63(a)(1), engineering control measures (e.g., 
enclosure or confinement of the operation, general and local 
ventilation) or administrative control measures (e.g., workplace 
policies and procedures) shall be considered and implemented to prevent 
exposure, where feasible.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (f), and (g)(1), (3) and (5). For purposes of 
Sec.  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 Sec.  
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 Sec.  721.80(o). It is a significant new use to 
manufacture, process, or use the substance in any manner that results 
in inhalation exposure.
    (iv) Release to water. Requirements as specified in Sec.  
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 Sec.  
721.125(a) through (i), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11847  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 Sec.  
721.63(a)(1), (3) through (5), (b), and (c). When determining which 
persons are reasonably likely to be exposed as required for Sec.  
721.63(a)(1) and (4), engineering control measures (e.g., enclosure or 
confinement of the operation, general and local ventilation) or 
administrative control measures (e.g., workplace policies and 
procedures) shall be considered and implemented to prevent exposure, 
where feasible. For purposes of Sec.  721.63(a)(5), respirators must 
provide a National Institute for Occupational Safety and Health (NIOSH) 
assigned protection factor (APF) of at least 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 Sec.  721.63(b), the concentration is set at 1.0%.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (f), (g)(1), and (5). For the purposes of Sec.  
721.72(e) the concentration is set at 1.0%. For purposes of Sec.  
721.72(g)(1), this substance may cause: 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 Sec.  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 Sec.  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 Sec.  
721.125(a) through (j) are applicable to manufacturers, importers, and 
processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11848   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 Sec.  
721.63(a)(1) and (3), (b), and (c). When determining which persons are 
reasonably likely to be exposed as required for Sec.  721.63(a)(1), 
engineering control measures (e.g., enclosure or confinement of the 
operation, general and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures) shall be considered 
and implemented to prevent exposure, where feasible. For purposes of 
Sec.  721.63(b), the concentration is set at 0.1%.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (f), (g)(1), (3), and (5). For purposes of Sec.  
721.72(e), the concentration is set at 0.1%. For purposes of Sec.  
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 Sec.  
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 Sec.  
721.90(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11849  Sulfonium, (halocarbomonocycle)diphenyl-, salt with 1-
heterosubstituted-2-methylalkyl 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 1-
heterosubstituted-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

[[Page 49792]]

processes) onto a semiconductor wafer surface or similar manufactured 
article used in the production of semiconductor technologies.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (2)(i) and (iii), (3), and (c). When determining which 
persons are reasonably likely to be exposed as required for Sec.  
721.63(a)(1), engineering control measures (e.g., enclosure or 
confinement of the operation, general and local ventilation) or 
administrative control measures (e.g., workplace policies and 
procedures) shall be considered and implemented to prevent exposure, 
where feasible.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (f), (g)(1), (2)(i) through (iii), (v), (3)(i) 
and (ii), and (5). For purposes of Sec.  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 Sec.  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 Sec.  
721.125(a) through (i) are applicable to manufacturers, importers, and 
processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11850  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 Sec.  
721.63(a)(1) and (3), and (c). When determining which persons are 
reasonably likely to be exposed as required for Sec.  721.63(a)(1), 
engineering control measures (e.g., enclosure or confinement of the 
operation, general and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures) shall be considered 
and implemented to prevent exposure, where feasible.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (f), (g)(1), (3), and (5). For purposes of Sec.  
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 Sec.  
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 Sec.  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 Sec.  
721.90(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (k) are applicable to manufacturers, importers, and 
processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11851  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-N3-octadecyl-, 
chloride (1:2); 1,3-Propanediaminium, 2-hydroxy-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-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-N3-octadecyl-, chloride (1:2); 1,3-
propanediaminium, 2-hydroxy-N1,N1,N1,N3,N3-pentamethyl-N3-octadecen-1-
yl, chloride (1:2) (PMN P-21-201; CASRNs 1622255-87-1; 63560-76-9; 
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 Sec.  
721.63(a)(1) and (3), (b), and (c). When determining which persons are 
reasonably likely to be exposed as required for Sec.  721.63(a)(1), 
engineering control measures (e.g., enclosure or confinement of the 
operation, general and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures) shall be considered 
and implemented to prevent exposure, where feasible. For purposes of 
Sec.  721.63(b), the concentration is set at 0.1%.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (f), (g)(1), (3), and (5). For purposes of Sec.  
721.72(e), the concentration is set at 1.0%. For purposes of Sec.  
721.72(g)(1), this substance may cause: acute toxicity, skin corrosion, 
skin irritation, serious eye damage, eye irritation, reproductive 
toxicity, and specific target organ toxicity. For purposes of Sec.  
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 Sec.  721.80(o). It is a

[[Page 49793]]

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 Sec.  
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 Sec.  
721.125(a) through (i), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11852  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 Sec.  
721.63(a)(1) and (3), (b) and (c). When determining which persons are 
reasonably likely to be exposed as required for Sec.  721.63(a)(1), 
engineering control measures (e.g., enclosure or confinement of the 
operation, general and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures) shall be considered 
and implemented to prevent exposure, where feasible. For purposes of 
Sec.  721.63(b), the concentration is set at 0.1%.
    (ii) Hazard communication. Requirements as specified in Sec.  
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 Sec.  
721.125(a) through (i), are applicable to manufacturers, importers, and 
processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11853  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, 3- hydroxy-
2,2-dimethylpropyl 3-hydroxy-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, 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, 1,3-isobenzofurandione 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 Sec.  
721.63(a)(1) and (3), and (c). When determining which persons are 
reasonably likely to be exposed as required for Sec.  721.63(a)(1), 
engineering control measures (e.g., enclosure or confinement of the 
operation, general and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures) shall be considered 
and implemented to prevent exposure, where feasible.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (f), (g)(1), and (5). For purposes of Sec.  
721.72(g)(1), this substance may cause: skin 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 Sec.  721.80(o). It is a significant new use to 
manufacture, process, or use the substance in any manner that results 
in inhalation exposure.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i) are applicable to manufacturers, importers, and 
processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11854  Polyester with 1,4-benzenedicarboxylic acid, 2,2-
dimethyl-1,3-propanediol, dodecanedioic acid, 1,2-ethanediol, aliphatic 
polyester, 3-hydroxy-2,2-dimethylpropyl 3- hydroxy-2,2-
dimethylpropanoate, 1,3-isobenzofurandione and 1,1'-methylenebis[4- 
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-2,2-dimethylpropyl 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 Sec.  
721.63(a)(1) and (3), and (c). When determining which persons are 
reasonably likely to be exposed as required for Sec.  721.63(a)(1), 
engineering control measures (e.g., enclosure or confinement of the 
operation, general and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures) shall be considered 
and implemented to prevent exposure, where feasible.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (f), (g)(1), and (5). For purposes of Sec.  
721.72(g)(1), this substance may cause: skin 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 Sec.  721.80(o). It is a

[[Page 49794]]

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 Sec.  
721.125(a) through (i) are applicable to manufacturers, importers, and 
processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11855  Polyester with 1,4-benzenedicarboxylic acid, 2,2-
dimethyl-1,3-propanediol, dodecanedioic acid, 1,2-ethanediol, aliphatic 
polyester, 3-hydroxy-2,2-dimethylpropyl 3-hydroxy-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-2,2-dimethylpropyl 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 Sec.  
721.63(a)(1) and (3), and (c). When determining which persons are 
reasonably likely to be exposed as required for Sec.  721.63(a)(1), 
engineering control measures (e.g., enclosure or confinement of the 
operation, general and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures) shall be considered 
and implemented to prevent exposure, where feasible.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (f), (g)(1), and (5). For purposes of Sec.  
721.72(g)(1), this substance may cause: skin 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 Sec.  721.80(o). It is a significant new use to 
manufacture, process, or use the substance in any manner that results 
in inhalation exposure.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i) are applicable to manufacturers, importers, and 
processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11856  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 Sec.  
721.63(a)(1), (2)(i) and (iii), (3), and (c). When determining which 
persons are reasonably likely to be exposed as required for Sec.  
721.63(a)(1), engineering control measures (e.g., enclosure or 
confinement of the operation, general and local ventilation) or 
administrative control measures (e.g., workplace policies and 
procedures) shall be considered and implemented to prevent exposure, 
where feasible.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (f), (g)(1), (2)(i) through (iii), (v), (3)(i) 
and (ii), and (5). For purposes of Sec.  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 Sec.  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 Sec.  
721.125(a) through (i) are applicable to manufacturers, importers, and 
processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11857  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 Sec.  
721.63(a)(1), (3) through (5), and (c). When determining which persons 
are reasonably likely to be exposed as required for Sec.  721.63(a)(1) 
and (4), engineering control measures (e.g., enclosure or confinement 
of the operation, general and local ventilation) or administrative 
control measures (e.g., workplace policies and procedures) shall be 
considered and implemented to prevent exposure, where feasible. For 
purposes of Sec.  721.63(a)(5), respirators must provide a National 
Institute for Occupational Safety and Health (NIOSH) assigned 
protection factor (APF) of at least 50.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (f), (g)(1), (3), and (5). For purposes of Sec.  
721.72(g)(1), this substance may cause: acute toxicity, skin corrosion, 
serious eye damage, skin

[[Page 49795]]

sensitization, reproductive toxicity, and specific target organ 
toxicity. For purposes of Sec.  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 Sec.  721.80(o).
    (iv) Release to water. Requirements as specified in Sec.  
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 Sec.  
721.125(a) through (i), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11858   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 Sec.  
721.63(a)(1) and (3), (b), and (c). When determining which persons are 
reasonably likely to be exposed as required for Sec.  721.63(a)(1), 
engineering control measures (e.g., enclosure or confinement of the 
operation, general and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures) shall be considered 
and implemented to prevent exposure, where feasible. For purposes of 
Sec.  721.63(b), the concentration is set at 0.1%.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a).
    (iii) Industrial, commercial, and consumer use. Requirements as 
specified in Sec.  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 Sec.  
721.125(a) through (i), are applicable to manufacturers, importers, and 
processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11859  Sulfonium, tricarbocyclic-, alpha, alpha, beta, beta-
polyhalopolyhydro-heteropolycyclic-5-alkanesulfonate (1:1) (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
sulfonium, tricarbo- cyclic-, alpha, alpha, beta, beta-
polyhalopolyhydro-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 Sec.  
721.63(a)(1), (2)(i) and (iii), (3), and (c). When determining which 
persons are reasonably likely to be exposed as required for Sec.  
721.63(a)(1), engineering control measures (e.g., enclosure or 
confinement of the operation, general and local ventilation) or 
administrative control measures (e.g., workplace policies and 
procedures) shall be considered and implemented to prevent exposure, 
where feasible.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (f), (g)(1), (2)(i) through (iii), (v), (3)(i) 
and (ii), and (5). For purposes of Sec.  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 Sec.  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 Sec.  
721.125(a) through (i) are applicable to manufacturers, importers, and 
processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11860  Sulfonium, tricarbocyclic-, 2-heteroatom-substituted-
4-alkylcarbomonocyclecarboxylate (1:1) (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
sulfonium, tricarbo- cyclic-, 2-heteroatom-substituted-4-
alkylcarbomonocyclecarboxylate (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 Sec.  
721.63(a)(1), (2)(i) and (iii), (3), and (c). When determining which 
persons are reasonably likely to be exposed as required for Sec.  
721.63(a)(1), engineering control measures (e.g., enclosure or 
confinement of the operation, general and local ventilation) or 
administrative control measures (e.g., workplace policies and 
procedures) shall be considered and implemented to prevent exposure, 
where feasible.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (f), (g)(1), (2)(i) through (iii), (v), (3)(i) 
and (ii), and (5). For purposes of Sec.  721.72(g)(1), this substance 
may

[[Page 49796]]

cause: acute toxicity, skin irritation, serious eye damage, skin 
sensitization, genetic toxicity, and specific target organ toxicity. 
Alternative hazard and warning statements that meet the criteria of the 
Globally Harmonized System and OSHA Hazard Communication Standard may 
be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f), (k), and (t). It is a significant new 
use to import the substance other than in solution 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 Sec.  
721.125(a) through (i) are applicable to manufacturers, importers, and 
processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11861  Sulfonium, tricarbocyclic-, salt with [polyhydro-2-
alkyl-5-(polyhalo-2-heteroalkyl)- 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, tricarbo cyclic-, salt with [polyhydro-2-alkyl-5-(polyhalo-
2-heteroalkyl)- alkano-1,3-hetropolycyclic]alkyl polyhaloaryl ester 
(1:1) (PMN P-22-161) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section. The 
requirements of this section do not apply to quantities of the 
substance after they have been completely reacted or adhered (during 
photolithographic processes) onto a semiconductor wafer surface or 
similar manufactured article used in the production of semiconductor 
technologies.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (2)(i) and (iii), (3), and (c). When determining which 
persons are reasonably likely to be exposed as required for Sec.  
721.63(a)(1), engineering control measures (e.g., enclosure or 
confinement of the operation, general and local ventilation) or 
administrative control measures (e.g., workplace policies and 
procedures) shall be considered and implemented to prevent exposure, 
where feasible.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (f), (g)(1), (2)(i) through (iii), (v), (3)(i) 
and (ii), and (5). For purposes of Sec.  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 Sec.  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 Sec.  
721.125(a) through (i) are applicable to manufacturers, importers, and 
processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11862  Sulfonium, tricarbocyclic-, alpha, alpha, beta, beta-
polyhalopolyhydro-heteropolycyclic-5-alkanesulfonate (1:1) (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
sulfonium, tricarbo cyclic-, alpha, alpha, beta, beta-
polyhalopolyhydro-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 Sec.  
721.63(a)(1), (2)(i) and (iii), (3), and (c). When determining which 
persons are reasonably likely to be exposed as required for Sec.  
721.63(a)(1), engineering control measures (e.g., enclosure or 
confinement of the operation, general and local ventilation) or 
administrative control measures (e.g., workplace policies and 
procedures) shall be considered and implemented to prevent exposure, 
where feasible.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (f), (g)(1), (2)(i) through (iii), (v), (3)(i) 
and (ii), and (5). For purposes of Sec.  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 Sec.  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 Sec.  
721.125(a) through (i) are applicable to manufacturers, importers, and 
processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

[FR Doc. 2024-12620 Filed 6-10-24; 8:45 am]
BILLING CODE 6560-50-P