`[Federal Register Volume 89, Number 242 (Tuesday, December 17, 2024)]
[Proposed Rules]
[Pages 102046-102074]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-29275]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 721

[EPA-HQ-OPPT-2024-0079; FRL-12386-01-OCSPP]
RIN 2070-AB27


Significant New Use Rules on Certain Chemical Substances (24-
3.5e)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing significant new use rules (SNURs) under the 
Toxic Substances Control Act (TSCA) for certain chemical substances 
that were the subject of premanufacture notices (PMNs) and are also 
subject to an Order issued by EPA pursuant to TSCA. The SNURs require 
persons who intend to manufacture (defined by statute to include 
import) or process any of these chemical substances for an activity 
that is proposed as a significant new use by this rulemaking to notify 
EPA at least 90 days before commencing that activity. The required 
notification initiates EPA's evaluation of the conditions of that use 
for that chemical substance. In addition, the manufacture or processing 
for the significant new use may not commence until EPA has conducted a 
review of the required notification, made an appropriate determination 
regarding that notification, and taken such actions as required by that 
determination.

DATES: Comments must be received on or before January 16, 2025.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2024-0079, 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: Jordan Garbin, New Chemicals Division 
(7405M), Office of Pollution Prevention and Toxics, Environmental 
Protection

[[Page 102047]]

Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone 
number: (202) 564-4156; email address: [email protected].
    For general information on SNURs: William Wysong, New Chemicals 
Division (7405M), Office of Pollution Prevention and Toxics, 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, 
DC 20460-0001; telephone number: (202) 564-4163; email address: 
[email protected].
    For general information on TSCA: 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 the chemical substances discussed in 
Unit III. These SNURs, if finalized as proposed, would require persons 
who intend to manufacture or process any of these chemical substances 
for an activity that is designated as a significant new use to notify 
EPA at least 90 days before commencing that activity.

C. Does this action apply to me?

1. General Applicability
    This action applies to you if you manufacture, process, or use the 
chemical substances contained in this proposed rule. The following list 
of North American Industrial Classification System (NAICS) codes is not 
intended to be exhaustive, but rather provides a guide to help readers 
determine whether this document applies to them. Potentially affected 
entities may include:
     Manufacturers or processors of one or more subject 
chemical substances (NAICS codes 325 and 324110), e.g., chemical 
manufacturing and petroleum refineries.
2. Applicability to Importers and Exporters
    This action may also apply to certain entities through pre-existing 
import certification and export notification requirements under TSCA 
(https://www.epa.gov/tsca-import-export-requirements).
    Chemical importers are subject to TSCA section 13 (15 U.S.C. 2612), 
the requirements in 19 CFR 12.118 through 12.127, 19 CFR 127.28, and 
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 
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 January 16, 2025 are subject to TSCA section 12(b) (15 
U.S.C. 2611(b)) and must comply with the export notification 
requirements in 40 CFR part 707, subpart D.

D. What are the incremental economic impacts of this action?

    EPA has evaluated the potential costs of establishing SNUN 
reporting requirements for potential manufacturers (including 
importers) and processors of the chemical substances subject to these 
proposed SNURs. This analysis, which is available in the docket, is 
briefly summarized here.
1. Estimated Costs for SNUN Submissions
    If a SNUN is submitted, costs are an estimated $45,000 per SNUN 
submission for large business submitters and $14,500 for small business 
submitters. These estimates include the cost to prepare and submit the 
SNUN (including registration for EPA's Central Data Exchange (CDX)), 
and the payment of a user fee. Businesses that submit a SNUN would be 
subject to either a $37,000 user fee required by 40 CFR 
700.45(c)(2)(ii) and (d), or, if they are a small business as defined 
at 13 CFR 121.201, a reduced user fee of $6,480 (40 CFR 
700.45(c)(1)(ii) and (d)) per fiscal year 2022. The costs of submission 
for SNUNs will not be incurred by any company unless a company decides 
to pursue a significant new use as defined in these SNURs. 
Additionally, these estimates reflect the costs and fees as they are 
known at the time of this rulemaking.
2. Estimated Costs for Export Notifications
    EPA has also evaluated the potential costs associated with the 
export notification requirements under TSCA section 12(b) and the 
implementing regulations at 40 CFR part 707, subpart D. For persons 
exporting a substance that is the subject of a SNUR, a one-time notice 
to EPA must be provided for the first export or intended export to a 
particular country. The total costs of export notification will vary by 
chemical, depending on the number of required notifications (i.e., the 
number of countries to which the chemical is exported). While EPA is 
unable to make any estimate of the likely number of export 
notifications for the chemical substances covered by these SNURs, as 
stated in the accompanying economic analysis, the estimated cost of the 
export notification requirement on a per unit basis is approximately 
$106.

E. What should I consider as I prepare my comments for EPA?

1. Submitting CBI
    Do not submit CBI to EPA through email or https://www.regulations.gov. If you wish to include CBI in your comment, please 
follow the applicable instructions at https://www.epa.gov/dockets/commenting-epa-dockets#rules and clearly mark the information that you 
claim to be CBI. Information so marked will not be disclosed except in 
accordance with procedures set forth in 40 CFR parts 2 and 703.
2. Tips for Preparing Your Comments
    When preparing and submitting your comments, see the commenting 
tips at https://www.epa.gov/dockets/commenting-epa-dockets.

II. Background

    This unit provides general information about SNURs. For additional 
information about EPA's new chemical program go to https://www.epa.gov/reviewing-new-chemicals-under-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,

[[Page 102048]]

processing, distribution in commerce, and disposal of a chemical 
substance.
    In determining what would constitute a significant new use for the 
chemical substances that are the subject of these SNURs, EPA considered 
relevant information about the toxicity of the chemical substances, and 
potential human exposures and environmental releases that may be 
associated with the substances, in the context of the four bulleted 
TSCA section 5(a)(2) factors listed in this unit and discussed in Unit 
III.
    These proposed SNURs include PMN substances that are subject to 
orders issued under TSCA section 5(e)(1)(A), as required by the 
determinations made under TSCA section 5(a)(3)(B). The TSCA orders 
require protective measures to limit exposures or otherwise mitigate 
the potential unreasonable risk. The proposed SNURs identify as 
significant new uses any manufacturing, processing, use, distribution 
in commerce, or disposal that does not conform to the restrictions 
imposed by the underlying TSCA orders, consistent with TSCA section 
5(f)(4).

B. Rationale and Objectives of the SNURs

1. Rationale
    Under TSCA, no person may manufacture a new chemical substance or 
manufacture or process a chemical substance for a significant new use 
until EPA makes a determination as described in TSCA section 5(a) and 
takes any required action. The issuance of a SNUR is not a risk 
determination itself, only a notification requirement for ``significant 
new uses,'' so that the Agency has the opportunity to review the SNUN 
for the significant new use and make a TSCA section 5(a)(3) risk 
determination.
    During review of the PMNs submitted that are the subject to these 
proposed SNURs, EPA concluded that regulation was warranted under TSCA 
section 5(e), pending the development of information sufficient to make 
reasoned evaluations of the health or environmental effects of the 
chemical substances. Based on the findings outlined in Unit III., TSCA 
section 5(e) Orders requiring the use of appropriate exposure controls 
were negotiated with the PMN submitters. As a general matter, EPA 
believes it is necessary to follow the TSCA Orders with a SNUR that 
identifies the absence of those protective measures as significant new 
uses to ensure that all manufacturers and processors--not just the 
original submitter--are held to the same standard.
2. Objectives
    EPA is proposing these SNURs because the Agency 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 703. Absent a final determination or 
other disposition of the confidentiality claim under these regulations, 
EPA is required to keep this information confidential. EPA promulgated 
a procedure at 40 CFR 721.11 to deal with the situation where a 
specific significant new use is CBI. Under these procedures. a 
manufacturer or processor may request EPA to identify the confidential 
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. If EPA concludes that the person has shown a bona 
fide intent to manufacture or process the chemical substance, EPA will 
identify the confidential significant new use to that person. Since 
most of the chemical identities of the chemical substances subject to 
these SNURs are also CBI, manufacturers and processors can combine the 
bona fide submission under the procedure in 40 CFR 721.11 into a single 
step.

D. Applicability of General Provisions

    General provisions for SNURs appear in 40 CFR part 721, subpart A. 
These provisions describe persons subject to SNURs, recordkeeping 
requirements, exemptions to reporting requirements, and applicability 
of the rule to uses occurring before the effective date of the rule. 
Pursuant to 40 CFR 721.1(c), persons subject to SNURs must comply with 
the same requirements and EPA regulatory procedures as submitters of 
PMNs under TSCA section 5(a)(1)(A). In particular, these requirements 
include the information submission requirements of TSCA sections 5(b) 
and 5(d)(1), the exemptions authorized by TSCA sections 5(h)(1), 
5(h)(2), 5(h)(3), and 5(h)(5) and the regulations at 40 CFR part 720. 
In addition, provisions relating to user fees appear at 40 CFR part 
700.
    Once EPA receives a SNUN, EPA must either determine that the 
significant new use is not likely to present an unreasonable risk of 
injury under the conditions of use for the chemical substance or take 
such regulatory action as is associated with an alternative 
determination under TSCA section 5 before the manufacture (including 
import) or processing for the significant new use can commence. If EPA 
determines that the significant new use of the chemical substance is 
not likely to present an unreasonable risk, EPA is required under TSCA 
section 5(g) to make public, and submit for publication in the Federal 
Register, a statement of EPA's findings.
    As discussed in Unit I.C.2., persons who export or intend to export 
a chemical substance identified in a proposed or final SNUR are subject 
to the export notification provisions of TSCA section 12(b), and 
persons who import a chemical substance identified in a final SNUR are 
subject to the TSCA section 13 import certification requirements. See 
also 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

[[Page 102049]]

received determinations under TSCA section 5(a)(3)(C). TSCA Orders have 
been issued for these chemical substances and the PMN submitters are 
required by the TSCA Orders to submit a SNUN before undertaking 
activities that would be designated as significant new uses in these 
SNURs. Additionally, the identities of many of the chemical substances 
subject to this proposed rule have been claimed as confidential per 40 
CFR 720.85, further reducing the likelihood that another party would 
manufacture or process the substances for an activity that would be 
designated as a significant new use. Based on this, the Agency believes 
that it is highly unlikely that any of the significant new uses 
identified in Unit III. are ongoing.
    When the chemical substances identified in Unit III. are added to 
the TSCA Inventory, EPA recognizes that, before the rule is effective, 
other persons might engage in a use that has been identified as a 
significant new use. Persons who begin manufacture or processing of the 
chemical substances for a significant new use identified on or after 
the designated cutoff date specified in Unit III.A. would have to cease 
any such activity upon the effective date of the final rule. To resume 
their activities, these persons would have to first comply with all 
applicable SNUR notification requirements and EPA would have to take 
action under TSCA section 5 allowing manufacture or processing to 
proceed.

F. Important Information About SNUN Submissions

1. SNUN Submissions
    SNUNs must be submitted on EPA Form No. 7710-25, generated using e-
PMN software, and submitted to the Agency in accordance with the 
procedures set forth in 40 CFR 720.40 and 721.25. E-PMN software is 
available electronically at 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. may not 
be the only means of providing information to evaluate the chemical 
substance associated with the significant new uses. However, submitting 
a SNUN without any test data may increase the likelihood that EPA will 
take action under TSCA sections 5(e) or 5(f). EPA recommends that 
potential SNUN submitters contact EPA early enough so that they will be 
able to conduct the appropriate tests.
    SNUN submitters should be aware that EPA will be better able to 
evaluate SNUNs that provide detailed information on the 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 December 17, 2024 as the cutoff date for determining 
whether the new use is ongoing. This designation is explained in more 
detail in Unit II.E.

B. What information is provided for each chemical substance?

    For each chemical substance identified in Unit III.C., EPA provides 
the following information:
     PMN number (the proposed CFR citation assigned in the 
regulatory text section of the proposed rule).
     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).
     Basis for the action (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 these proposed rules?

    The substances subject to the proposed rules in this document are 
as follows:
PMN Number (Proposed CFR Citation): P-18-127 (40 CFR 721.12043)
    Chemical Name: Heptane, 2-methoxy-2-methyl-.
    CASRN: 76589-16-7.
    Effective Date of TSCA Order: December 15, 2023.
    Basis for TSCA Order: The PMN states that the use will be as a 
fragrance for household and consumer products, mainly laundry 
detergents. Based on submitted test data on the PMN substance, EPA has 
identified concerns for skin sensitization. Based on comparison to 
analogous chemical substances, EPA has also identified concerns for 
systemic and developmental effects. Based on submitted test data on the 
PMN substance, EPA predicts toxicity to

[[Page 102050]]

aquatic organisms may occur at concentrations that exceed 210 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:
     Manufacture of the PMN substance only by import into the 
United States in a solution of no greater than 5% by weight (i.e., no 
domestic manufacture);
     Processing of the PMN substance only in a solution of no 
greater than 5% by weight of the PMN substance;
     Processing for use or use of the PMN substance in consumer 
products only if the concentration of the PMN substance is less than 1% 
by weight;
     No release of the PMN substance, or any waste stream 
containing the PMN substance, in surface water concentrations that 
exceed 210 ppb;
     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 
developmental toxicity, specific target organ toxicity, and pulmonary 
effects 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-18-325 (40 CFR 721.12044)
    Chemical Name: Benzenesulfonic acid, alkyl-, compd. with 1,1'-
iminobis[2-propanol] (1:1) (generic).
    CASRN: Not available.
    Effective Date of TSCA Order: January 9, 2024.
    Basis for TSCA Order: The PMN states that the use will be as an 
industrial crosslinking catalyst. Based on the structure of the anion, 
EPA identified concerns for lung toxicity (surfactant effects). Based 
on test data for the neutral form of the cation and analogues for the 
anion, EPA also identified concerns for skin and eye irritation, and 
systemic and reproductive effects. Based on comparison to analogous 
anionic surfactants, EPA predicts toxicity to aquatic organisms may 
occur at concentrations that exceed 0.4 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:
     No manufacture, processing, or use of the PMN substance in 
any manner that results in inhalation exposure to the PMN substance;
     No processing for use or use of the PMN substance other 
than as an industrial cross-linking catalyst;
     No release of the PMN substances, or any waste stream 
containing the PMN substances, into waters of the United States;
     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/corrosion, eye irritation/corrosion, pulmonary effects, 
specific target organ toxicity, and aquatic toxicity testing may be 
potentially useful to characterize the health and environmental effects 
of the PMN substance. Although the Order does not require these tests, 
the Order's restrictions remain in effect until the Order is modified 
or revoked by EPA based on submission of this or other relevant 
information.
PMN Number (Proposed CFR Citation): P-20-14 (40 CFR 721.12045)
    Chemical Name: Sugars, polymer with alkanetriamine (generic).
    CASRN: Not available.
    Effective Date of TSCA Order: January 27, 2023.
    Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as a water resistant resin additive. Based on 
comparison to analogous chemical substances, EPA has identified 
concerns for systemic effects (body weight). Based on potential 
chelation to nutrient metals, EPA has also identified concerns for 
developmental and systemic effects. Based on submitted test data on the 
PMN substance, EPA predicts toxicity to aquatic organisms may occur at 
concentrations that exceed 191 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:
     No use of the PMN substance in a consumer product;
     No release of the PMN substance, or any waste stream 
containing the PMN substance, in surface water concentrations that 
exceed 191 ppb;
     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 
reproductive toxicity and specific target organ 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-21-86 (40 CFR 721.12046)
    Chemical Name: Isooctadecanamide, N,N-bis(2-ethylhexyl)-.
    CASRN: 1616494-50-8.
    Effective Date of TSCA Order: February 6, 2024.
    Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as an automotive engine

[[Page 102051]]

additive. Based on test data for the metabolite, EPA has identified 
concerns for systemic effects. The Order was issued under TSCA sections 
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the 
absence of sufficient information to permit a reasoned evaluation, the 
substance may present an unreasonable risk of injury to human health. 
To protect against these risks, the Order requires:
     No processing for use of the PMN substance in a consumer 
product where the concentration of the PMN substance in the consumer 
product formulation exceeds the confidential percentage listed in the 
Order;
     No use of the PMN substance in a consumer product where 
the concentration of the PMN substance exceeds the confidential 
percentage listed in the Order;
     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 
metabolism or pharmacokinetics 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 Number (Proposed CFR Citation): P-21-164 (40 CFR 721.12047)
    Chemical Name: 2-Butanone, oxime, reaction products with 
trimethoxymethylsilane.
    CASRN: 2639393-45-4.
    Effective Date of TSCA Order: November 13, 2023.
    Basis for TSCA Order: The PMN states that the use will be as a 
crosslinker for waterproofing. Based on comparison to analogous 
chemical substances, EPA has identified concerns for irritation to skin 
and eyes and systemic effects. Based on test data for hydrolysis 
products, EPA has also identified concerns for acute toxicity, skin 
irritation, eye corrosion, respiratory tract irritation and corrosion, 
skin sensitization, systemic effects, developmental effects, 
neurotoxicity and carcinogenicity. Based on test data for hydrolysis 
products, EPA predicts toxicity to aquatic organisms may occur at 
concentrations that exceed 102 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:
     No use of the PMN substance unless at 4% or less by weight 
in formulation;
     No loading or unloading of the PMN substance for 
manufacture, processing, or use unless under a gas (e.g., nitrogen) 
blanket;
     Application of the PMN substance for use only by roll, 
brush, or dip coating;
     Use of personal protective equipment where there is a 
potential for dermal exposure;
     Use of a NIOSH-certified combination particulate and gas/
vapor respirator with an APF of at least 50 where there is a potential 
for inhalation exposure;
     Disposal of the PMN substance, or waste streams containing 
the PMN substance, only by incineration;
     No release of the PMN substance, or any waste stream 
containing the PMN substance, into waters of the United States; 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 acute 
toxicity, carcinogenicity, eye damage, pulmonary effects, skin 
irritation, 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-21-170 (40 CFR 721.12048)
    Chemical Name: 2,6-Bis(dialkyl)-4-[2-(1-alkyl-4(1H)-
pyridinylidene)alkylidene]-2,5-cycloalkyladien-1-one (generic).
    CASRN: Not available.
    Effective Date of TSCA Order: January 27, 2024.
    Basis for TSCA Order: The PMN states that the use will be as a 
color indicator for frying oil breakdown. Based on comparison to 
analogous chemical substances, EPA has identified concerns for 
irritation to skin and eyes, skin sensitization, neurotoxicity, 
systemic effects (respiratory tract, lung, liver, kidney, spleen, and 
body weight effects), reproductive and developmental effects, 
genotoxicity, carcinogenicity, and acute toxicity (mortality). Based on 
OECD Toolbox results, EPA identified concerns for skin sensitization 
and based on information provided in the SDS, EPA has also identified 
concerns for acute toxicity and irritation to skin, eyes, and 
respiratory tract. Based on comparison to analogous chemical 
substances, EPA predicts toxicity to aquatic organisms may occur at 
concentrations that exceed 1 ppb. The Order was issued under TSCA 
sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding 
that in the absence of sufficient information to permit a reasoned 
evaluation, the substance may present an unreasonable risk of injury to 
human health and the environment. To protect against these risks, the 
Order requires:
     Manufacture of the PMN substance only below an annual 
volume of 10 kg;
     No manufacture, processing, or use of the PMN substance 
resulting in releases to air except with the use of a HEPA filtration 
system;
     No processing for use or use of the PMN substance other 
than as a color indicator for frying oil breakdown;
     No processing for use or use of the PMN substance where 
the concentration of the PMN substance in the final product exceeds 
0.008%;
     No release of the PMN substance, or any waste stream 
containing the PMN substance, into waters of the United States;
     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.

[[Page 102052]]

    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 
biodegradation, bioaccumulation, log P, and aquatic toxicity testing 
may be potentially useful to characterize the physical/chemical 
properties and environmental fate/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-21-184 (40 CFR 721.12049)
    Chemical Name: Fatty acids, soya, reaction products with ammonia-
ethanolamine reaction by-products.
    CASRN: 2378512-59-3.
    Effective Date of TSCA Order: November 16, 2023.
    Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be in asphalt emulsion applications. Based on 
comparison to analogous chemical substances, EPA has identified 
concerns for acute toxicity, skin and eye irritation/corrosion, skin 
sensitization, point-of-contact effects, lung effects, and systemic 
effects. Based on the surfactant-like properties of the PMN substance 
and its use as an emulsifier, EPA has also identified concerns for lung 
effects (surfactancy). Based on information in the SDS, EPA has also 
identified concerns for skin irritation, eye corrosion, and respiratory 
irritation. Based on comparison to analogous aliphatic amines, EPA 
predicts toxicity to aquatic organisms may occur at concentrations that 
exceed 2 ppb. The Order was issued under TSCA sections 
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the 
absence of sufficient information to permit a reasoned evaluation, the 
substance may present an unreasonable risk of injury to human health 
and the environment. To protect against these risks, the Order 
requires:
     No manufacture, processing, or use of the PMN substance in 
any manner that results in the generation of vapor, mist, dust, or 
aerosol;
     No processing for use or use of the PMN substance in a 
consumer product;
     Use of personal protective equipment where there is a 
potential for dermal exposure;
     No release of the PMN substance, or any waste stream 
containing the PMN substance, in surface water concentrations that 
exceed 2 ppb; 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 acute 
toxicity, specific target organ toxicity, pulmonary effects, skin 
irritation/corrosion, eye damage, neurotoxicity, skin sensitization, 
and aquatic toxicity testing may be potentially useful to characterize 
the health and environmental effects of the PMN substance. Although the 
Order does not require these tests, the Order's restrictions remain in 
effect until the Order is modified or revoked by EPA based on 
submission of this or other relevant information.
PMN Numbers (Proposed CFR Citations): P-22-3 (40 CFR 721.12050), P-22-4 
(40 CFR 721.12051), P-22-5 (40 CFR 721.12052), and P-22-6 (40 CFR 
721.12053)
    Chemical Names: 1,5-Pentanediamine, 2-methyl-, hydrochloride (1:2) 
(P-22-3), 1,5-Pentanediamine, 2-methyl-, hydrochloride (1:1) (P-22-4), 
Formic acid, compd. with 2-methyl-1,5- pentanediamine (2:1) (P-22-5), 
and Formic acid, compd. with 2-methyl-1,5-pentanediamine (1:1) (P-22-
6).
    CASRNs: 34813-63-3 (P-22-3), 1840915-04-9 (P-22-4), 1836131-73-7 
(P-22-5), and 1836131-75-9 (P-22-6).
    Effective Date of TSCA Order: December 4, 2023.
    Basis for TSCA Order: The PMNs state that the uses will be as clay 
stabilizers for oil and gas fracking. Based on submitted test data on 
the P-22-3 substance, comparison to analogous chemical substances, 
structure and expected acidity or basicity of components, physical/
chemical properties of components, and information provided in the SDS, 
EPA has identified concerns for acute toxicity, irritation or corrosion 
to skin, eyes, and respiratory tract, and systemic effects. Based on 
submitted test data for the P-22-3 substance, EPA predicts toxicity to 
aquatic organisms may occur at concentrations that exceed 570 ppb. The 
Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 
5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient 
information to permit a reasoned evaluation, the substances may present 
an unreasonable risk of injury to human health and the environment. To 
protect against these risks, the Order requires:
     No processing for use or use of the PMN substances in 
consumer products;
     No manufacture, processing, or use of the PMN substances 
in any manner that results in inhalation exposure to the PMN 
substances;
     Use of personal protective equipment where there is a 
potential for dermal exposure;
     No release of the PMN substances, or any waste stream 
containing the PMN substances, in surface water concentrations that 
exceed 570 ppb combined; 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 eye 
irritation/corrosion, skin irritation/corrosion, specific target organ 
toxicity, pulmonary effects, and aquatic toxicity testing may be 
potentially useful to characterize the health and environmental effects 
of the PMN substances. Although the Order does not require these tests, 
the Order's restrictions remain in effect until the Order is modified 
or revoked by EPA based on submission of this or other relevant 
information.
PMN Number (Proposed CFR Citation): P-22-11 (40 CFR 721.12054)
    Chemical Name: Alkadiene, homopolymer, hydroxy-terminated, bis[N-
[2-[(1-oxo-2-propen-1- yl)oxylethyl]carbamates] (generic).
    CASRN: Not available.
    Effective Date of TSCA Order: November 27, 2023.
    Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as a functionalized rubber in the resin side 
of two component epoxy

[[Page 102053]]

modified acrylic adhesive and as a functionalized rubber in the resin 
side of two component acrylic adhesive. Based on test data on one or 
both of the two components in the formulation, EPA has identified 
concerns for skin sensitization, and systemic, reproductive, and 
developmental effects. Based on the weight of the scientific evidence, 
EPA has also identified concerns for respiratory sensitization. Based 
on information in the SDS, EPA has also identified concerns for skin 
sensitization and reproductive toxicity. The Order was issued under 
TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a 
finding that in the absence of sufficient information to permit a 
reasoned evaluation, the substance may present an unreasonable risk of 
injury to human health. To protect against these risks, the Order 
requires:
     No use of the PMN substance in a consumer product;
     No manufacture, processing, or use of the PMN substance in 
any manner that results in 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 
sensitization, developmental toxicity, reproductive toxicity, and 
specific target organ toxicity testing may be potentially useful to 
characterize the health effects of the PMN substance. Although the 
Order does not require these tests, the Order's restrictions remain in 
effect until the Order is modified or revoked by EPA based on 
submission of this or other relevant information.
PMN Number (Proposed CFR Citation): P-22-25 (40 CFR 721.12055)
    Chemical Name: Oxirane, 2-(chloromethyl)-, homopolymer, ether with 
dialkyl-alkanediol (2:1) (generic).
    CASRN: Not available.
    Effective Date of TSCA Order: February 20, 2024.
    Basis for TSCA Order: The PMN states that the use will be as a 
chemical intermediate. Based on comparison to analogous chemical 
substances and structural alerts, EPA has identified concerns for acute 
toxicity, irritation to the respiratory tract, skin, and eyes, systemic 
effects, genetic toxicity, 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. To protect against these risks, the Order 
requires:
     No exceedance of the confidential annual production volume 
listed in the Order;
     No manufacture, processing, or use of the PMN substance in 
any manner that results in the generation of a vapor, mist, dust, or 
aerosol;
     Use of the PMN substance only as a chemical intermediate;
     Disposal of the PMN substance, or waste streams containing 
the PMN substance, only by hazardous waste incineration;
     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; 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 acute 
toxicity, specific target organ toxicity, pulmonary effects, eye 
irritation, skin irritation, genetic toxicity, and carcinogenicity 
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 Number (Proposed CFR Citation): P-22-49 (40 CFR 721.12056)
    Chemical Name: Aryl, polymer with formaldehyde, glycidyl ether, 
reaction products with amino alkyl-alkane diamine, cyclohexanediamine 
and alkylene (alkylcyclohexanamine) (generic).
    CASRN: Not available.
    Effective Date of TSCA Order: January 11, 2024.
    Basis for TSCA Order: The PMN states that the use will be as a 
hardener in coatings for oil and gas, power, and chemical/petrochemical 
industries for tank and pipe linings and for asset protection, in 
coatings in wastewater applications industries for tank and pipe 
linings and for asset protection, in coatings used in manufacturing 
industries for tank and pipe linings and for asset protection, and in 
OEM automotive and heavy industrial machinery coatings. Based on 
submitted test data on the PMN substance, EPA has identified concerns 
for acute toxicity. Based on residual data, EPA has also identified 
concerns for irritation to the skin, eye, and respiratory tract, skin 
and respiratory sensitization, systemic, developmental, and 
reproductive effects, corrosion to all tissues, and genetic toxicity. 
Based on submitted test data on the PMN substance and comparison to 
analogous polycationic polymers, EPA predicts toxicity to aquatic 
organisms may occur at concentrations that exceed 2 ppb. The Order was 
issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), 
based on a finding that in the absence of sufficient information to 
permit a reasoned evaluation, the substance may present an unreasonable 
risk of injury to human health or the environment. To protect against 
these risks, the Order requires:
     No release of the PMN substance, or any waste stream 
containing the PMN substance, in surface water concentrations that 
exceed 2 ppb;
     Use of a NIOSH-certified particulate respirator with an 
APF of at least 1,000 where there is a potential for inhalation 
exposure;
     No use of the PMN substance in a consumer product;
     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

[[Page 102054]]

determined that the results of skin irritation, skin corrosion, eye 
irritation, eye corrosion, specific target organ toxicity, pulmonary 
effects, and aquatic toxicity testing may be potentially useful to 
characterize the health and environmental effects of the PMN substance. 
Although the Order does not require these tests, the Order's 
restrictions remain in effect until the Order is modified or revoked by 
EPA based on submission of this or other relevant information.
PMN Number (Proposed CFR Citation): P-22-50 (40 CFR 721.12057)
    Chemical Name: Alkene, alkoxy-, polymer with alkoxyalkene 
(generic).
    CASRN: Not available.
    Effective Date of TSCA Order: January 8, 2024.
    Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as a lubricant. Based on comparison to 
analogous chemical substances, EPA has identified concerns for skin, 
eye, and respiratory tract irritation and systemic effects. Based on 
comparison to analogous neutral organics, EPA predicts toxicity to 
aquatic organisms may occur at concentrations that exceed 32 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:
     No processing for use or use of the PMN substance in a 
consumer product;
     No manufacture, processing, or use of the PMN substance in 
any manner that results in inhalation exposure to the PMN substance;
     No processing for use or use of the PMN substance other 
than 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; 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 
specific target organ toxicity, skin irritation, eye irritation, 
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-22-58 (40 CFR 721.12058)
    Chemical Name: Methanesulfonamide, 1,1,1-trifluoro-N-
[(trifluoromethyl)sulfonyl]-, sodium salt (1:1).
    CASRN: 91742-21-1.
    Effective Date of TSCA Order: February 13, 2024.
    Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as a process chemical. Based on submitted 
test data on the PMN substance, EPA has identified concerns for acute 
toxicity and serious eye damage. Based on comparison to analogous 
chemical substances, EPA has also identified concerns for respiratory 
tract and skin irritation, neurotoxicity, systemic, reproductive, and 
developmental effects. Based on comparison to analogous chemical 
substances, EPA has also identified concerns for respiratory, systemic, 
and neurological effects for the potential incineration product of the 
anion. Based on submitted test data on the PMN substance and comparison 
to analogous substances, EPA predicts toxicity to aquatic organisms may 
occur at concentrations that exceed 140 ppb. The Order was issued under 
TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a 
finding that in the absence of sufficient information to permit a 
reasoned evaluation, the substance may present an unreasonable risk of 
injury to human health and the environment. To protect against these 
risks, the Order requires:
     No manufacture of the PMN substance other than in an 
enclosed process;
     No processing or use of the PMN substance other than in a 
manner that does not generate a vapor, mist, dust, or aerosol that 
results in inhalation exposure to workers;
     No use of the PMN substance other than for the 
confidential use listed in the Order;
     No use of the PMN substance other than in the form of a 
liquid;
     No release of the PMN substance, or any waste stream 
containing the PMN substance, in surface water concentrations that 
exceed 100 ppb;
     Use of a NIOSH-certified combination particulate and gas/
vapor respirator with an APF of at least 50 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 
specific target organ toxicity, pulmonary effects, reproductive 
toxicity, developmental toxicity, neurotoxicity, sediment 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-22-75 (40 CFR 721.12059)
    Chemical Name: 1H-Isoindole-1,3(2H)-dione, 3a,4,7,7a-tetrahydro-2-
(2-hydroxyethyl)-.
    CASRN: 15458-48-7.
    Effective Date of TSCA Order: January 19, 2024.
    Basis for TSCA Order: The PMN states that the use will be as a 
monomer used to produce an unsaturated polyester resin. Based on 
comparison to analogous chemical substances, EPA has identified 
concerns for acute toxicity, skin and eye irritation, and systemic 
effects. Based on comparison to analogous imides, 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 and the environment. To 
protect against these risks, the Order requires:

[[Page 102055]]

     Manufacture of the PMN substance only at or below an 
annual volume of 3,000 kg;
     No domestic manufacture of the PMN substance (i.e., import 
only);
     No use of the PMN substance other than as a monomer used 
to produce an unsaturated polyester resin;
     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 acute 
toxicity, eye irritation, skin irritation, pulmonary effects, specific 
target organ toxicity, and aquatic toxicity testing may be potentially 
useful to characterize the health and environmental effects of the PMN 
substance. Although the Order does not require these tests, the Order's 
restrictions remain in effect until the Order is modified or revoked by 
EPA based on submission of this or other relevant information.
PMN Number (Proposed CFR Citation): P-22-78 (40 CFR 721.12060)
    Chemical Name: Oxirane, 2-methyl-, polymer with oxirane, mono-
isoalkyl ethers, phosphates, salt (generic).
    CASRN: Not available.
    Effective Date of TSCA Order: November 27, 2023.
    Basis for TSCA Order: The PMN states that the use will be as a 
dispersing agent for pesticide formulations. Based on structure, EPA 
has identified concerns for lung effects (surfactancy). Based on 
comparison to analogous chemical substances, EPA has also identified 
concerns for skin irritation and systemic effects. Based on comparison 
to analogous anionic surfactants, 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 and the environment. To protect against 
these risks, the Order requires:
     No processing for use or use of the PMN substance other 
than as a dispersing agent for pesticide formulations;
     No manufacture or processing of the PMN substance in any 
manner that results in the generation of a vapor, mist, dust, or 
aerosol;
     Use of personal protective equipment where there is a 
potential for dermal exposure;
     No release of the PMN substance, or any waste stream 
containing the PMN substance, in surface water concentrations that 
exceed 23 ppb; 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 effects, skin irritation, 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-22-80 (40 CFR 721.12061)
    Chemical Name: Poly(oxy-1,2-ethanediyl), .alpha.-(2-
aminoethyl)-.omega.-(2-aminoethoxy)- and Poly(oxy-1,2-ethanediyl), 
.alpha.,.alpha.',-(iminodi-2,1- ethanediyl)bis[.omega.-(2-
aminoethoxy)-.
    CASRNs: 24991-53-5 and 90350-34-8.
    Effective Date of TSCA Order: December 1, 2023.
    Basis for TSCA Order: The PMN states that the use will be as an 
industrial intermediate used in the manufacture of polyamides as a 
monomer. Based on the pH of the PMN substance, EPA has identified 
concerns for skin, eye, and respiratory tract corrosion. Based on 
comparison to analogous chemical substances, EPA has also identified 
concerns for acute toxicity and skin sensitization. Based on comparison 
to analogous polycationic polymers, EPA predicts toxicity to aquatic 
organisms may occur at concentrations that exceed 0.7 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:
     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 0.7 ppb;
     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 acute 
toxicity, skin corrosion, eye corrosion, pulmonary effects, skin 
sensitization, and aquatic toxicity testing may be potentially useful 
to characterize the health and environmental effects of the PMN 
substance. Although the Order does not require these tests, the Order's 
restrictions remain in effect until the Order is modified or revoked by 
EPA based on submission of this or other relevant information.
PMN Number (Proposed CFR Citation): P-22-82 (40 CFR 721.12062)
    Chemical Name: Alkenoic acid, alkyl, carbopolycyclic alkyl ester, 
polymer with trihalo (trihaloalkyl) alkyl alkyl alkenoate (generic).
    CASRN: Not available.
    Effective Date of TSCA Order: November 3, 2023.
    Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as a component of photoresist. Based on test 
data on the degradation product and an analogue of the degradation 
product, EPA has identified concerns for neurotoxicity, reproductive, 
developmental, and systemic effects. Based on the potential 
incineration product, EPA has also identified concerns for systemic 
effects, and neurotoxicity. The Order was issued under TSCA sections

[[Page 102056]]

5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the 
absence of sufficient information to permit a reasoned evaluation, the 
substance may present an unreasonable risk of injury to human health. 
To protect against these risks, the Order requires:
     No manufacture of the PMN substance other than by import 
into the United States (i.e., no domestic manufacture) in a liquid 
formulation;
     No processing or use of the PMN substance other than in a 
liquid formulation;
     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;
     Disposal of the PMN substance, or waste streams containing 
the PMN substance, only by incineration;
     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 
pulmonary effects, reproductive and developmental effects, and 
neurotoxicity 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 Number (Proposed CFR Citation): P-22-121 (40 CFR 721.12063)
    Chemical Name: Polychloroalkene (generic).
    CASRN: Not available.
    Effective Date of TSCA Order: February 6, 2024.
    Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as a process intermediate. Based on submitted 
test data on the PMN substance and information in the SDS, EPA has 
identified concerns for acute toxicity (oral) and skin sensitization. 
Based on test data for analogues, EPA identified concerns for acute 
toxicity (oral, inhalation), skin irritation, eye corrosion, 
respiratory irritation, genotoxicity, carcinogenicity, and systemic 
effects. Based on submitted acute test data and comparison to analogous 
chemical substances, EPA predicts toxicity to aquatic organisms may 
occur at concentrations that exceed 0.15 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 and the environment. To protect against these 
risks, the Order requires:
     No domestic manufacture of the PMN substance (i.e., import 
only);
     No processing, use, loading, or unloading of the PMN 
substance unless under a gas (e.g., nitrogen) blanket or in a closed 
system except that sampling may occur outside the closed system 
resulting in exposures;
     No use of the PMN substance other than for the 
confidential use listed in the Order;
     Use of a NIOSH-certified combination particulate and gas/
vapor respirator with an APF of at least 50 where there is a potential 
for inhalation exposure;
     Use of personal protective equipment where there is a 
potential for dermal exposure;
     No release of the PMN substance, or any waste stream 
containing the PMN substance, in surface water concentrations that 
exceed 0.15 ppb; 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 
carcinogenicity, eye irritation/corrosion, genetic toxicity, pulmonary 
effects, skin irritation, specific target organ toxicity, 
toxicokinetics, 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-22-145 (40 CFR 721.12064)
    Chemical Name: Alkanoic acid, trialkyl-, diester with 
carbomonocycle bis(alkyleneoxy)]bis[alkanediol] (generic).
    CASRN: Not available.
    Effective Date of TSCA Order: February 21, 2024.
    Basis for TSCA Order: The PMN states that the use will be as a 
reactive-diluent in a polyol component of a 2K (Isocyanate-Polyol) 
Urethane coating system for interior concrete floor sealant or 
interior/exterior paver sealer. 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 test data on 
structurally similar substances, the PMN substance is a potentially 
persistent, bioaccumulative, and toxic (PBT) chemical. EPA estimates 
that the PMN substance will persist in the environment for more than 
six months and estimates a bioconcentration factor of greater than or 
equal to 5,000. Based on test data for a potential hydrolysis product, 
EPA has identified concerns for acute toxicity and systemic, 
reproductive, and developmental effects. Based on comparison to 
analogous esters, EPA predicts toxicity to aquatic organisms may occur 
at concentrations that exceed 0.14 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:
     No use of the PMN substance in any manner that generates a 
spray, mist, vapor, or aerosol containing the PMN substance unless the 
concentration of the PMN substance is less than 5.7% by weight;
     No processing for use or use of the PMN substance in a 
consumer product;
     No release of the PMN substance, or any waste stream 
containing the PMN substance, into waters of the United States;
     Disposal of the PMN substance, or waste streams containing 
the PMN substance, only by incineration;
     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.

[[Page 102057]]

    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, reproductive toxicity, developmental toxicity, specific 
target organ toxicity, toxicokinetics, 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-22-175 (40 CFR 721.12065)
    Chemical Name: Modified Silsesquioxane, alkoxy-terminated 
(generic).
    CASRN: Not available.
    Effective Date of TSCA Order: January 30, 2024.
    Basis for TSCA Order: The PMN states that the use will be as a 
curable binder resin for composite stone articles (engineered stone). 
Based on comparison to analogous alkoxysilanes and other analogous 
chemical substances, EPA has identified concerns for lung toxicity. 
Based on the reactivity of the PMN substance and the low molecular 
weight fraction content, EPA has also identified concerns for 
irritation to the skin, eyes, and respiratory tract. Based on 
comparison with analogous chemical substances, EPA has also identified 
concerns for hematological effects (i.e., increased neutrophils, 
eosinophils, lymphocytes) associated with lung toxicity. Based on 
comparison to analogous alkoxysilanes, EPA predicts toxicity to aquatic 
organisms may occur at concentrations that exceed 7 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:
     No domestic manufacture of the PMN substance (i.e., import 
only);
     Use of the PMN substance only if the concentration of the 
PMN substance does not exceed 10% by weight in formulation;
     Use of a NIOSH-certified respirator with an APF of at 
least 10 where there is a potential for inhalation exposure;
     No release of the PMN substance, or any waste stream 
containing the PMN substance, in surface water concentrations that 
exceed 7 ppb;
     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 irritation, 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-23-18 (40 CFR 721.12066)
    Chemical Name: Vegetable oil, polymer with pimelin ketone, 
oxymethylene and polymethylenepolyphenylene isocyanate (generic).
    CASRN: Not applicable.
    Effective Date of TSCA Order: February 23, 2024.
    Basis for TSCA Order: The PMN states that the use will be as an 
industrial adhesive. Based on the weight of the scientific evidence, 
EPA has identified concerns for skin and respiratory sensitization and 
lung toxicity for the PMN substance and the low molecular weight 
fraction. Based on test data for residuals and comparison to analogous 
chemical substances of the residuals, EPA has also identified acute 
toxicity, irritation to the skin, eyes, and respiratory tract, skin 
sensitization, respiratory sensitization, neurotoxicity, lung effects, 
systemic effects, reproductive and developmental effects, genetic 
toxicity, and carcinogenicity for the residuals. The Order was issued 
under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a 
finding that in the absence of sufficient information to permit a 
reasoned evaluation, the substance may present an unreasonable risk of 
injury to human health. To protect against these risks, the Order 
requires:
     No manufacture, processing, or use of the PMN substance in 
any manner that results in inhalation exposure to the PMN substance;
     No processing for use or use of the PMN substance in a 
consumer product;
     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, skin sensitization, and pulmonary effects testing may be 
potentially useful to characterize the health effects of the PMN 
substance. Although the Order does not require these tests, the Order's 
restrictions remain in effect until the Order is modified or revoked by 
EPA based on submission of this or other relevant information.
PMN Number (Proposed CFR Citation): P-23-20 (40 CFR 721.12067)
    Chemical Name: Silsesquioxanes, 3-mercaptopropyl, polymers with 
silicic acid (H4SiO4) tetra-Et ester, [(trimethylsilyl)oxy]-terminated.
    CASRN: 2796383-42-9.
    Effective Date of TSCA Order: November 21, 2023.
    Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as an additive/intermediate. Based on 
comparison to analogous chemical substances and alkoxysilanes, EPA has 
identified concerns for lung effects. Based on analogue data for the 
hydrolysis product, EPA has also identified concerns for skin 
sensitization and systemic effects. Based on comparison to analogous 
alkoxysilanes and thiols, 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

[[Page 102058]]

present an unreasonable risk of injury to human health and the 
environment. To protect against these risks, the Order requires:
     Use of the PMN substance only for the confidential use 
listed in the Order;
     No manufacture, processing, or use of the PMN substance in 
any manner that results in inhalation exposure to the PMN substance;
     Use of personal protective equipment where there is a 
potential for dermal exposure;
     No release of the PMN substance, or any waste stream 
containing the PMN substance, in surface water concentrations that 
exceed 3 ppb; 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 
specific target organ toxicity, pulmonary effects, skin sensitization, 
and aquatic toxicity testing may be potentially useful to characterize 
the health and environmental effects of the PMN substance. Although the 
Order does not require these tests, the Order's restrictions remain in 
effect until the Order is modified or revoked by EPA based on 
submission of this or other relevant information.
PMN Number (Proposed CFR Citation): P-23-36 (40 CFR 721.12068).
    Chemical Name: Castor oil, polymer with dicyclopentadiene, maleic 
anhydride, 2-methyl-1,3-propanediol, 3a,4,7,7a-tetrahydro-2-(2-
hydroxyethyl)-1H-isoindole-1,3(2H)-dione and triethylene glycol.
    CASRN: 2794200-69-2.
    Effective Date of TSCA Order: January 19, 2024.
    Basis for TSCA Order: The PMN states that the use will be as a 
resin used in an electrical insulation coating to insulate electrical 
components (motors) in automobiles. Based on test data for the expected 
hydrolysis product and an analogue of the expected hydrolysis product, 
EPA has identified concerns for skin irritation, eye irritation, 
systemic effects, and reproductive/developmental effects. Based on 
comparison to analogous nonionic polymers, EPA predicts toxicity to 
aquatic organisms may occur at concentrations that exceed 27 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:
     No processing for use or use of the PMN substance in a 
consumer product;
     No manufacture, processing, or use of the PMN substance in 
any manner that generates a vapor, mist, dust, or aerosol;
     Use of personal protective equipment where there is a 
potential for dermal exposure;
     No release of the PMN substance, or any waste stream 
containing the PMN substance, in surface water concentrations that 
exceed 27 ppb; 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 irritation, specific target organ toxicity, 
toxicokinetics, 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 Numbers (Proposed CFR Citations): P-23-37 (40 CFR 721.12069), P-23-
44 (40 CFR 721.12070), P-23-80 (40 CFR 721.12071), and P-23-93 (40 CFR 
721.12072)
    Chemical Names: Monoaromatic cyclic alkylene sulfonium fluoroalkyl 
sulfonic acid salt (generic) (P-23-37 and P-23-44), Aromatic sulfonium 
tricyclo fluoroalkyl sulfonic acid salt (generic) (P-23-80), and 
Aromatic dibenzothiophenium fluoroalkyl carbopolycycle sulfonic acid 
salt (generic) (P-23-93).
    CASRNs: Not available.
    Effective Date of TSCA Order: December 22, 2023.
    Basis for TSCA Order: The PMNs state that the generic (non-
confidential) use of the PMN substances will be as photoacid generators 
(PAGs) for use in electronics industry. 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 test data on 
structurally similar substances, the PMN substance 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. Based on comparison to 
analogous chemical compounds, EPA has identified concerns for acute 
toxicity, irritation to the skin and respiratory tract, neurological 
effects, and systemic effects for the cation of the PMN substances, as 
well as eye corrosion for P-23-44, P-23-80, and P-23-93. Based on 
comparison to analogous chemical substances, EPA has also identified 
concerns for genetic toxicity for the PMN substances, and skin 
sensitization and portal-of-entry (respiratory) effects for P-23-93. 
Based on the photoreactivity of the PMN substances, EPA has also 
identified concerns for photosensitization. Based on comparison to 
analogous compounds, EPA has also identified concerns for systemic and 
reproductive effects for the anion of P-23-44 and P-23-93. Based on 
data on a potential incineration product, EPA identified concerns for 
local and systemic effects via inhalation exposure. Based on a lack of 
scientific data, there is 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 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 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;

[[Page 102059]]

     Use of the PMN substances only for the confidential uses 
listed in the Order;
     No domestic manufacture of the PMN substances (i.e., 
import only);
     Import of the PMN substances only in solution or in sealed 
containers weighing 5 kilograms or less; and
     No exceedance of the confidential annual importation 
volumes listed the Order.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially Useful Information: EPA has determined that certain 
information about the physical/chemical properties, fate, 
bioaccumulation, environmental hazard, and human health effects of the 
PMN substances may be potentially useful in support of a request by the 
PMN submitter to modify the Order, or if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that will be 
designated by this SNUR. The submitter has agreed not to exceed the 
time limits specified in the Order without performing the required Tier 
I and Tier II testing outlined in the Testing section of the Order.
PMN Number (Proposed CFR Citation): P-23-64 (40 CFR 721.12073)
    Chemical Name: Alkanediol, substituted, polymer with 
diisocyanatoalkane, substituted heterocycle-modified (generic).
    CASRN: Not available.
    Effective Date of TSCA Order: February 21, 2024.
    Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as a component in aerospace coatings. Based 
on comparison to analogous chemical substances, EPA has identified 
concerns for pulmonary effects, systemic effects, and skin 
sensitization. The Order was issued under TSCA sections 
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the 
absence of sufficient information to permit a reasoned evaluation, the 
substance may present an unreasonable risk of injury to human health. 
To protect against these risks, the Order requires:
     No processing for use or use of the PMN substance in 
consumer products;
     No manufacture, processing, or use of the PMN substance in 
any manner that results in the generation of a vapor, mist, dust, or 
aerosol;
     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 
pulmonary effects 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 Number (Proposed CFR Citation): P-23-72 (40 CFR 721.12074)
    Chemical Name: Halosubstituted carbopolycycle, polymer with 
substituted carbomonocycles and oxybis[alkanol] (generic).
    CASRN: Not available.
    Effective Date of TSCA Order: February 22, 2024.
    Basis for TSCA Order: The PMN states that the use will be as a UV 
resin for offset lithographic printing on plastic substrates. 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 test data on structurally similar substances, the PMN substance is 
a potentially persistent, bioaccumulative, and toxic (PBT) chemical. 
EPA estimates that the PMN substance will persist in the environment 
for more than six months and estimates a bioaccumulation factor of 
greater than or equal to 5,000. Based on test data for hydrolysis 
products of the low molecular weight fraction of the PMN substance, EPA 
has identified concerns for genetic toxicity, carcinogenicity, and 
systemic, reproductive, and developmental effects. Based on comparison 
to analogous esters, EPA predicts toxicity to aquatic organisms may 
occur at concentrations that exceed 0.4 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:
     No processing for use or use of the PMN substance in a 
consumer product;
     No processing for use or use of the PMN substance other 
than in an enclosed roll-coating lithographic printing machine;
     No processing for use or use of the PMN substance in a 
final coating formulation that exceeds 40% by weight;
     Disposal of the PMN substance only by landfill;
     No release of the PMN substance, or any waste stream 
containing the PMN substance, into waters of the United States;
     Use of a NIOSH-certified 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 
carcinogenicity, developmental toxicity, genetic toxicity, reproductive 
toxicity, specific target organ toxicity, toxicokinetics, 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-23-94 (40 CFR 721.12075)
    Chemical Name: Polymer of benzenedicarboxylic acid, substituted-
benzenedicarboxylic acid, branched-alkyldiol, alkyldiol and 
triisocyanate (generic).
    CASRN: Not available.
    Effective Date of TSCA Order: January 9, 2024.
    Basis for TSCA Order: The PMN states that the use will be as a 
reactive polymer for use in surface pre-treatment. Based on test data 
for the feedstock residual, EPA has identified concerns for lung 
effects for the residual. Based on OECD QSAR Toolbox results and the 
structural alert for diisocyanates, EPA has also identified

[[Page 102060]]

concerns for dermal and respiratory sensitization. The Order was issued 
under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a 
finding that in the absence of sufficient information to permit a 
reasoned evaluation, the substance may present an unreasonable risk of 
injury to human health. To protect against these risks, the Order 
requires:
     No processing for use or use of the PMN substance in a 
consumer product;
     No manufacture, processing, or use of the PMN substance in 
any manner that results in inhalation exposure to the PMN substance;
     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 
specific target organ toxicity, pulmonary effects, and skin 
sensitization testing may be potentially useful to characterize the 
health effects of the PMN substance. Although the Order does not 
require these tests, the Order's restrictions remain in effect until 
the Order is modified or revoked by EPA based on submission of this or 
other relevant information.
PMN Number (Proposed CFR Citation): P-23-172 (40 CFR 721.12076)
    Chemical Name: Sulfonium, tricarbocyclic-, alkylcarbomonocyclic-
polyfluoro-heteropolycyclic-alkyl sulfonate (1:1), polymer with 
alkylaryl and carbomonocyclic alkylalkanoate, di-Me 2,2'-(1,2-
diazenediyl)bis[2-alkylalkanoate]-initiated (generic).
    CASRN: Not available.
    Effective Date of TSCA Order: January 29, 2024.
    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 test data on structurally similar substances, the 
PMN substance is a potentially persistent, bioaccumulative, and toxic 
(PBT) chemical. EPA estimates that the PMN substance will persist in 
the environment for more than six months and estimates unknown 
bioaccumulation. Based on comparison to analogous sulfonium compounds, 
EPA has identified concerns for acute toxicity, irritation to the skin 
and respiratory tract, eye corrosion, neurological effects, and 
systemic effects for the sulfonium cation. Based on comparison to 
analogous chemical substances, EPA has also identified concerns for 
genetic toxicity. Based on the photoreactivity of the PMN substance, 
EPA has also identified concerns for photosensitization. Based on a 
potential incineration product (trifluroacetate), EPA has also 
identified concerns for local, neurological, developmental and systemic 
effects via inhalation exposure. 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 precautionary statements on each label and in the SDS;
     No modification of the processing 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 
listed in the Order;
     No domestic manufacture of the PMN substance (i.e., import 
only);
     Import of the PMN substance only in solution or in sealed 
containers weighing 5 kilograms or less; and
     No exceedance of the confidential annual importation 
volume listed the Order.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially Useful Information: EPA has determined that certain 
information about the physical/chemical properties, fate, 
bioaccumulation, environmental hazard, and human health effects of the 
PMN substance may be potentially useful in support of a request by the 
PMN submitter to modify the Order, or if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that will be 
designated by this SNUR. The submitter has agreed not to exceed the 
time limits specified in the Order without performing the required Tier 
I and Tier II testing outlined in the Testing section of the Order.

IV. Statutory and Executive Order Reviews

    Additional information about these statutes and Executive Orders 
can be found at https://www.epa.gov/laws-regulations-and-executive-orders.

A. Executive Order 12866: Regulatory Planning and Review and Executive 
Order 14094: Modernizing Regulatory Review

    This action proposes to establish SNURs for new chemical substances 
that were the subject of PMNs. The Office of Management and Budget 
(OMB) has exempted these types of actions from review under Executive 
Order 12866 (58 FR 51735, October 4, 1993), as amended by Executive 
Order 14094 (88 FR 21879, April 11, 2023).

B. Paperwork Reduction Act (PRA)

    According to the PRA (44 U.S.C. 3501 et seq.), an agency may not 
conduct or sponsor, and a person is not required to respond to a 
collection of information that requires OMB approval under PRA, unless 
it has been approved by OMB and displays a currently valid OMB control 
number. The OMB control numbers for EPA's regulations in title 40 of 
the CFR, after appearing in the Federal Register, are listed in 40 CFR 
part 9, and included on the related collection instrument or form, if 
applicable.
    The information collection requirements related to SNURs have 
already been approved by OMB pursuant to PRA under OMB control number 
2070-0038 (EPA ICR No. 1188). This action does not impose any burden 
requiring additional OMB approval. If an entity were to submit a SNUN 
to the Agency, the annual burden is estimated to average between 30 and 
170 hours per submission. This burden estimate includes the time needed 
to review instructions, search existing data sources, gather and 
maintain the data needed, and complete, review, and submit the required 
SNUN.
    EPA always welcomes your feedback on the burden estimates. Send any 
comments about the accuracy of the burden estimate, and any suggested 
methods for improving the collection instruments or instruction or 
minimizing respondent burden,

[[Page 102061]]

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 1995 dollars) in any one year as described in UMRA, 2 U.S.C. 
1531-1538, and does not significantly or uniquely affect small 
governments. Based on EPA's experience with proposing and finalizing 
SNURs, State, local, and Tribal governments have not been impacted by 
SNURs, and EPA does not have any reasons to believe that any State, 
local, or Tribal government will be impacted by these SNURs. In 
addition, the estimated costs of this action to the private sector do 
not exceed $183 million or more in any one year (the 1995 dollars are 
adjusted to 2023 dollars for inflation using the GDP implicit price 
deflator). The estimated costs for this action are discussed in Unit 
I.D.

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 a human health risk, 
EPA's 2021 Policy on Children's Health also does not apply. Although 
the establishment of these SNURs do not address an existing children's 
environmental health concern because the chemical uses involved are not 
ongoing uses, SNURs require that persons notify EPA at least 90 days 
before commencing manufacture (defined by statute to include import) or 
processing of 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 intended uses 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

    EPA believes that this type of action does not concern human health 
or environmental conditions and therefore cannot be evaluated with 
respect to the potentially disproportionate and adverse effects on 
communities with environmental justice concerns in accordance with 
Executive Orders 12898 (59 FR 7629, February 16, 1994) and 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 will allow EPA to assess the intended uses to 
identify potential disproportionate risks and take appropriate actions 
before the activities commence.

List of Subjects in 40 CFR part 721

    Environmental protection, Chemicals, Hazardous substances, 
Reporting and recordkeeping requirements.


Kevin DeBell,
Acting 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).


[[Page 102062]]


0
2. Add Sec. Sec.  721.12043 through 721.12076 to Subpart E to read as 
follows:

Subpart E--Significant New Uses for Specific Chemical Substances

Sec.
* * * * *
721.12043 Heptane, 2-methoxy-2-methyl-.
721.12044 Benzenesulfonic acid, alkyl-, compd. with 1,1'-iminobis[2-
propanol] (1:1) (generic).
721.12045 Sugars, polymer with alkanetriamine (generic).
721.12046 Isooctadecanamide, N,N-bis(2-ethylhexyl)-.
721.12047 2-Butanone, oxime, reaction products with 
trimethoxymethylsilane.
721.12048 2,6-Bis(dialkyl)-4-[2-(1-alkyl-4(1H)-
pyridinylidene)alkylidene]-2,5-cycloalkyladien-1-one (generic).
721.12049 Fatty acids, soya, reaction products with ammonia-
ethanolamine reaction by-products.
721.12050 1,5-Pentanediamine, 2-methyl-, hydrochloride (1:2).
721.12051 1,5-Pentanediamine, 2-methyl-, hydrochloride (1:1).
721.12052 Formic acid, compd. with 2-methyl-1,5- pentanediamine 
(2:1).
721.12053 Formic acid, compd. with 2-methyl-1,5-pentanediamine 
(1:1).
721.12054 Alkadiene, homopolymer, hydroxy-terminated, bis[N-[2-[(1-
oxo-2-propen-1-yl)oxylethyl]carbamates] (generic).
721.12055 Oxirane, 2-(chloromethyl)-, homopolymer, ether with 
dialkyl-alkanediol (2:1) (generic).
721.12056 Aryl, polymer with formaldehyde, glycidyl ether, reaction 
products with amino alkyl-alkane diamine, cyclohexanediamine and 
alkylene (alkylcyclohexanamine) (generic).
721.12057 Alkene, alkoxy-, polymer with alkoxyalkene (generic).
721.12058 Methanesulfonamide, 1,1,1-trifluoro-N-
[(trifluoromethyl)sulfonyl]-, sodium salt (1:1).
721.12059 1H-Isoindole-1,3(2H)-dione, 3a,4,7,7a-tetrahydro-2-(2-
hydroxyethyl).
721.12060 Oxirane, 2-methyl-, polymer with oxirane, mono-isoalkyl 
ethers, phosphates, salt (generic).
721.12061 Poly(oxy-1,2-ethanediyl), .alpha.-(2-aminoethyl)-.omega.-
(2-aminoethoxy)- and Poly(oxy-1,2-ethanediyl), .alpha.,.alpha.',-
(iminodi-2,1- ethanediyl)bis[.omega.-(2-aminoethoxy)-.
721.12062 Alkenoic acid, alkyl, carbopolycyclic alkyl ester, polymer 
with trihalo (trihaloalkyl) alkyl alkyl alkenoate (generic).
721.12063 Polychloroalkene (generic).
721.12064 Alkanoic acid, trialkyl-, diester with carbomonocycle 
bis(alkyleneoxy)]bis[alkanediol] (generic).
721.12065 Modified Silsesquioxane, alkoxy-terminated (generic).
721.12066 Vegetable oil, polymer with pimelin ketone, oxymethylene 
and polymethylenepolyphenylene isocyanate (generic).
721.12067 Silsesquioxanes, 3-mercaptopropyl, polymers with silicic 
acid (H4SiO4) tetra-Et ester, [(trimethylsilyl)oxy]-terminated.
721.12068 Castor oil, polymer with dicyclopentadiene, maleic 
anhydride, 2-methyl-1,3-propanediol, 3a,4,7,7a-tetrahydro-2-(2-
hydroxyethyl)-1H-isoindole-1,3(2H)-dione and triethylene glycol.
721.12069 Monoaromatic cyclic alkylene sulfonium fluoroalkyl 
sulfonic acid salt (generic).
721.12070 Monoaromatic cyclic alkylene sulfonium fluoroalkyl 
sulfonic acid salt (generic).
721.12071 Aromatic sulfonium tricyclo fluoroalkyl sulfonic acid salt 
(generic).
721.12072 Aromatic dibenzothiophenium fluoroalkyl carbopolycycle 
sulfonic acid salt (generic).
721.12073 Alkanediol, substituted, polymer with diisocyanatoalkane, 
substituted heterocycle-modified (generic).
721.12074 Halosubstituted carbopolycycle, polymer with substituted 
carbomonocycles and oxybis[alkanol] (generic).
721.12075 Polymer of benzenedicarboxylic acid, substituted-
benzenedicarboxylic acid, branched-alkyldiol, alkyldiol and 
triisocyanate (generic).
721.12076 Sulfonium, tricarbocyclic-, alkylcarbomonocyclic-
polyfluoro-heteropolycyclic-alkyl sulfonate (1:1), polymer with 
alkylaryl and carbomonocyclic alkylalkanoate, di-Me 2,2'-(1,2-
diazenediyl)bis[2-alkylalkanoate]-initiated (generic).
* * * * *


Sec.  721.12043  Heptane, 2-methoxy-2-methyl-.

    (a) Chemical substance and significant new uses subject to 
reporting.
    (1) The chemical substance identified as Heptane, 2-methoxy-2-
methyl- (PMN P-18-127; CASRN 76589-16-7) is subject to reporting under 
this section for the significant new uses described in paragraph (a)(2) 
of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (3), and (c). When determining which persons are 
reasonably likely to be exposed as required for Sec.  721.63(a)(1), 
engineering control measures (e.g., enclosure or confinement of the 
operation, general and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures) shall be considered 
and implemented to prevent exposure, where feasible.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (f), (g)(1), (3), and (5). For purposes of Sec.  
721.72(g)(1), this substance may cause: skin sensitization 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 
OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f). It is a significant new use to 
manufacture the substance unless by import into the United States in a 
solution of no greater than 5% by weight (i.e., no domestic 
manufacture). It is a significant new use to process the substance 
unless in a solution of no greater than 5% by weight of the substance. 
It is a significant new use to process for use or use the substance in 
consumer products unless the concentration of the substance is less 
than 1% by weight.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4), where N=210.
    (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.  721.12044  Benzenesulfonic acid, alkyl-, compd. with 1,1'-
iminobis[2-propanol] (1:1) (generic).

    (a) Chemical substance and significant new uses subject to 
reporting.
    (1) The chemical substance identified generically as 
benzenesulfonic acid, alkyl-, compd. with 1,1'-iminobis[2-propanol] 
(1:1) (PMN P-18-325) 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

[[Page 102063]]

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 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 OSHA Hazard Communication 
Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k). It is a significant new use to 
manufacture, process, or use the substance in any manner that results 
in inhalation exposure to the substance. It is a significant new use to 
process for use or use the substance other than as an industrial cross-
linking catalyst.
    (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.  721.12045  Sugars, polymer with alkanetriamine (generic).

    (a) Chemical substance and significant new uses subject to 
reporting.
    (1) The chemical substance identified generically as sugars, 
polymer with alkanetriamine (PMN P-20-14) 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 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: 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 OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(o).
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4), where N=191.
    (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.  721.12046  Isooctadecanamide, N,N-bis(2-ethylhexyl)-.

    (a) Chemical substance and significant new uses subject to 
reporting.
    (1) The chemical substance identified as isooctadecanamide, N,N-
bis(2-ethylhexyl)- (PMN P-21-86; CASRN 1616494-50-8) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section. The requirements of this section do 
not apply to quantities of the substance after they have been entrained 
in a polymer.
    (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), 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. 
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. It is a 
significant new use to process the substance for use in a consumer 
product where the concentration of the substance in the consumer 
product formulation exceeds the confidential percentage listed in the 
Order. It is a significant new use to use the substance in a consumer 
product where the concentration of the substance exceeds the 
confidential percentage listed in the Order.
    (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.  721.12047  2-Butanone, oxime, reaction products with 
trimethoxymethylsilane.

    (a) Chemical substance and significant new uses subject to 
reporting.
    (1) The chemical substance identified as 2-butanone, oxime, 
reaction products with trimethoxymethylsilane (PMN P-21-164; CASRN 
2639393-45-4) 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 (6), and (c). When determining which persons 
are reasonably likely to be exposed as required for Sec.  721.63(a)(1) 
and (4), engineering control measures (e.g., enclosure or confinement 
of the operation, general and local ventilation) or administrative 
control measures (e.g., workplace policies and procedures) shall be 
considered and implemented to prevent exposure, where feasible. For 
purposes of Sec.  721.63(a)(5), respirators must provide a National 
Institute for Occupational Safety and Health (NIOSH) assigned 
protection factor (APF) of at least 50.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a)

[[Page 102064]]

through (d), (f), (g)(1), (3), and (5). For purposes of Sec.  
721.72(g)(1), this substance may cause: acute toxicity, 
carcinogenicity, serious eye damage, reproductive toxicity, skin 
irritation, skin sensitization, 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 OSHA Hazard Communication 
Standard may be used.
    (iii) Industrial, commercial, and consumer activities. It is a 
significant new use to load or unload the substance for manufacture, 
processing, or use in any manner unless under a gas (e.g. nitrogen) 
blanket. It is a significant new use to use the substance unless at 4% 
or less by weight in formulation. It is a significant new use to apply 
the substance for use unless by roll, brush, or dip coating.
    (iv) Disposal. Requirements as specified in Sec.  721.85(a)(1), 
(b)(1), and (c)(1).
    (v) Release to water. Requirements as specified in Sec.  
721.90(a)(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.  721.12048  2,6-Bis(dialkyl)-4-[2-(1-alkyl-4(1H)-
pyridinylidene)alkylidene]-2,5-cycloalkyladien-1-one (generic).

    (a) Chemical substance and significant new uses subject to 
reporting.
    (1) The chemical substance identified generically as 2,6-
bis(dialkyl)-4-[2-(1-alkyl-4(1H)-pyridinylidene)alkylidene]-2,5-
cycloalkyladien-1-one (generic) (PMN P-21-170) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (3) through (6), and (c). When determining which persons 
are reasonably likely to be exposed as required for Sec.  721.63(a)(1) 
and (4), engineering control measures (e.g., enclosure or confinement 
of the operation, general and local ventilation) or administrative 
control measures (e.g., workplace policies and procedures) shall be 
considered and implemented to prevent exposure, where feasible. For 
purposes of Sec.  721.63(a)(5), respirators must provide a National 
Institute for Occupational Safety and Health (NIOSH) assigned 
protection factor (APF) of at least 10.
    (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, skin sensitization, genetic toxicity, 
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 OSHA Hazard 
Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k), (t). It is a significant new use to 
manufacture the substance in excess of an annual volume of 10 kg. It is 
a significant new use to process for use or use the substance other 
than as a color indicator for frying oil breakdown. It is a significant 
new use to manufacture, process, or use the substance in any manner 
that results in the release of the substance to air except with the use 
of a HEPA filtration system.
    (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.  721.12049  Fatty acids, soya, reaction products with ammonia-
ethanolamine reaction by-products.

    (a) Chemical substance and significant new uses subject to 
reporting.
    (1) The chemical substance identified as fatty acids, soya, 
reaction products with ammonia-ethanolamine reaction by-products (PMN 
P-21-184; CASRN 2378512-59-3) 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), 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 corrosion, 
skin irritation, serious eye damage, eye irritation, skin 
sensitization, 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 OSHA Hazard Communication Standard may 
be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(o), and (y)(1) and (2). It is a 
significant new use to manufacture, process, or use the substance in 
any manner that results in the generation of vapor, mist, aerosol, or 
dust.
    (iv) 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 (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.  721.12050  1,5-Pentanediamine, 2-methyl-, hydrochloride (1:2).

    (a) Chemical substance and significant new uses subject to 
reporting.
    (1) The chemical substance identified as 1,5-pentanediamine, 2-
methyl-, hydrochloride (1:2) (PMN P-22-3; CASRN 34813-63-3) 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), (b), and (c). When determining which persons are

[[Page 102065]]

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: acute toxicity, skin 
irritation, 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 OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(o). It is a significant new use to 
manufacture, process, or use the substance in any manner that results 
in inhalation exposure to the substance.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4), where N=570 of P-22-3, P-22-4, P-22-
5, and P-22-6 combined.
    (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.  721.12051  1,5-Pentanediamine, 2-methyl-, hydrochloride (1:1).

    (a) Chemical substance and significant new uses subject to 
reporting.
    (1) The chemical substance identified as 1,5-pentanediamine, 2-
methyl-, hydrochloride (1:1) (PMN P-22-4; CASRN 1840915-04-9) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (3), (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: acute toxicity, skin 
irritation, eye irritation, serious eye damage, skin corrosion, 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 OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(o). It is a significant new use to 
manufacture, process, or use the substance in any manner that results 
in inhalation exposure to the substance.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4), where N=570 of P-22-3, P-22-4, P-22-
5, and P-22-6 combined.
    (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.  721.12052  Formic acid, compd. with 2-methyl-1,5- pentanediamine 
(2:1).

    (a) Chemical substance and significant new uses subject to 
reporting.
    (1) The chemical substance identified as formic acid, compd. with 
2-methyl-1,5- pentanediamine (2:1) (PMN P-22-5; CASRN 1836131-73-7) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1) 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: acute toxicity, 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 OSHA Hazard Communication 
Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(o). It is a significant new use to 
manufacture, process, or use the substance in any manner that results 
in inhalation exposure to the substance.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4), where N=570 of P-22-3, P-22-4, P-22-
5, and P-22-6 combined.
    (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.  721.12053  Formic acid, compd. with 2-methyl-1,5-pentanediamine 
(1:1).

    (a) Chemical substance and significant new uses subject to 
reporting.
    (1) The chemical substance identified as formic acid, compd. with 
2-methyl-1,5-pentanediamine (1:1) (PMN P-22-6; CASRN 1836131-75-9) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1) 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

[[Page 102066]]

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: acute toxicity, skin corrosion, 
skin irritation, serious eye damage, 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 
OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(o). It is a significant new use to 
manufacture, process, or use the substance in any manner that results 
in inhalation exposure to the substance.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4), where N=570 of P-22-3, P-22-4, P-22-
5, and P-22-6 combined.
    (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.  721.12054  Alkadiene, homopolymer, hydroxy-terminated, bis[N-[2-
[(1-oxo-2-propen-1- yl)oxylethyl]carbamates] (generic).

    (a) Chemical substance and significant new uses subject to 
reporting.
    (1) The chemical substance identified generically as alkadiene, 
homopolymer, hydroxy-terminated, bis[N-[2-[(1-oxo-2-propen-1-
yl)oxylethyl]carbamates] (PMN P-22-11) is subject to reporting under 
this section for the significant new uses described in paragraph (a)(2) 
of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (3), and (c). When determining which persons are 
reasonably likely to be exposed as required for Sec.  721.63(a)(1), 
engineering control measures (e.g., enclosure or confinement of the 
operation, general and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures) shall be considered 
and implemented to prevent exposure, where feasible.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (f), (g)(1), and (5). For purposes of Sec.  
721.72(g)(1), this substance may cause: skin sensitization, respiratory 
sensitization, reproductive toxicity, and specific target organ 
toxicity. Alternative hazard and warning statements that meet the 
criteria of the Globally Harmonized System and OSHA Hazard 
Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(o). It is a significant new use to 
manufacture, process, or use the substance in any manner that results 
in inhalation exposure to the substance.
    (b) Specific requirements. The provisions of Subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i) are applicable to manufacturers, importers, and 
processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.12055  Oxirane, 2-(chloromethyl)-, homopolymer, ether with 
dialkyl-alkanediol (2:1) (generic).

    (a) Chemical substance and significant new uses subject to 
reporting.
    (1) The chemical substance identified generically as oxirane, 2-
(chloromethyl)-, homopolymer, ether with dialkyl-alkanediol (2:1) (PMN 
P-22-25) 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), (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), 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: acute toxicity, skin 
irritation, eye irritation, genetic toxicity, carcinogenicity, and 
specific target organ toxicity. Alternative hazard and warning 
statements that meet the criteria of the Globally Harmonized System and 
OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(g), (t), (y)(1), and (2). It is a 
significant new use to manufacture, process, or use the substance in 
any manner that generates a vapor, mist, aerosol, or dust.
    (iv) Disposal. It is a significant new use to dispose of the 
substance, or waste streams containing 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.  721.12056  Aryl, polymer with formaldehyde, glycidyl ether, 
reaction products with amino alkyl-alkane diamine, cyclohexanediamine 
and alkylene (alkylcyclohexanamine) (generic).

    (a) Chemical substance and significant new uses subject to 
reporting.
    (1) The chemical substance identified generically as aryl, polymer 
with formaldehyde, glycidyl ether, reaction products with amino alkyl-
alkane diamine, cyclohexanediamine and alkylene (alkylcyclohexanamine) 
(PMN P-22-49) 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 (6), and (c). When determining which persons 
are reasonably likely to be exposed as required for Sec.  721.63(a)(1) 
and (4), engineering control measures (e.g.,

[[Page 102067]]

enclosure or confinement of the operation, general and local 
ventilation) or administrative control measures (e.g., workplace 
policies and procedures) shall be considered and implemented to prevent 
exposure, where feasible. For purposes of Sec.  721.63(a)(5), 
respirators must provide a National Institute for Occupational Safety 
and Health (NIOSH) assigned protection factor (APF) of at least 1,000.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (f), (g)(1), (3), and (5). For purposes of Sec.  
721.72(g)(1), this substance may cause: acute toxicity, skin 
irritation, eye irritation, skin corrosion, serious eye damage, 
respiratory sensitization, skin sensitization, genetic toxicity, 
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 OSHA Hazard Communication Standard may 
be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(o).
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4), where N=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 (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.  721.12057  Alkene, alkoxy-, polymer with alkoxyalkene (generic).

    (a) Chemical substance and significant new uses subject to 
reporting.
    (1) The chemical substance identified generically as alkene, 
alkoxy-, polymer with alkoxyalkene (PMN P-22-50) 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), (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 OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k) and (o). It is a significant new use to 
manufacture, process, or use the substance in any manner that results 
in inhalation exposure to the substance.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of Subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.12058  Methanesulfonamide, 1,1,1-trifluoro-N-
[(trifluoromethyl)sulfonyl]-, sodium salt (1:1).

    (a) Chemical substance and significant new uses subject to 
reporting.
    (1) The chemical substance identified as Methanesulfonamide, 1,1,1-
trifluoro-N-[(trifluoromethyl)sulfonyl]-, sodium salt (1:1) (PMN P-22-
58; CASRN 91742-21-1) 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 (6), (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. 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: acute toxicity, serious eye 
damage, skin 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 OSHA 
Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(b), (k), (v)(2), and (y)(1) and (2). It is 
a significant new use to process the substance in a manner that 
generates a vapor, mist, aerosol, or dust that results in inhalation to 
workers.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4), where N=100.
    (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.  721.12059  1H-Isoindole-1,3(2H)-dione, 3a,4,7,7a-tetrahydro-2-(2-
hydroxyethyl)-.

    (a) Chemical substance and significant new uses subject to 
reporting.
    (1) The chemical substance identified as 1H-Isoindole-1,3(2H)-
dione, 3a,4,7,7a-tetrahydro-2-(2-hydroxyethyl)- (PMN P-22-75; CASRN 
15458-48-7) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section. The 
requirements of this section do not apply to quantities of the 
substance after they have been completely reacted or cured.
    (2) The significant new uses are:

[[Page 102068]]

    (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 purposes of Sec.  
721.72(e), the concentration is set at 1.0%. For purposes of Sec.  
721.72(g)(1), this substance may cause: acute toxicity, skin 
irritation, 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 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 manufacture the substance in excess of an annual volume of 3,000 
kg. It is a significant new use to use the substance other than as a 
monomer used to produce an unsaturated polyester resin.
    (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.  721.12060  Oxirane, 2-methyl-, polymer with oxirane, mono-
isoalkyl ethers, phosphates, salt (generic).

    (a) Chemical substance and significant new uses subject to 
reporting.
    (1) The chemical substance identified generically as oxirane, 2-
methyl-, polymer with oxirane, mono-isoalkyl ethers, phosphates, salt 
(PMN P-22-78) 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), (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 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 
OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k). It is a significant new use to 
manufacture or process the substance in a manner that generates a 
vapor, mist, aerosol, or dust. It is a significant new use to process 
for use or use the substance other than as a dispersing agent for 
pesticide formulations.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4), where N=23.
    (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.  721.12061  Poly(oxy-1,2-ethanediyl), .alpha.-(2-
aminoethyl)-.omega.-(2-aminoethoxy)- and Poly(oxy-1,2-ethanediyl), 
.alpha.,.alpha.',-(iminodi-2,1- ethanediyl)bis[.omega.-(2-
aminoethoxy)-.

    (a) Chemical substance and significant new uses subject to 
reporting.
    (1) The chemical substance identified as poly(oxy-1,2-ethanediyl), 
.alpha.-(2-aminoethyl)-.omega.-(2-aminoethoxy)- and poly(oxy-1,2-
ethanediyl), .alpha.,.alpha.',-(iminodi-2,1- ethanediyl)bis[.omega.-(2-
aminoethoxy)- (PMN P-22-80; CAS Nos. 24991-53-5 and 90350-34-8) 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 destroyed.
    (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), (3), and (5). For purposes of Sec.  
721.72(g)(1), this substance may cause: acute toxicity, skin corrosion, 
serious eye damage, and skin sensitization. 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 OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. It is a 
significant new use to manufacture, process, or use the substance in 
any manner that results in inhalation exposure to the substance.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4), where N=0.7.
    (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.  721.12062  Alkenoic acid, alkyl, carbopolycyclic alkyl ester, 
polymer with trihalo (trihaloalkyl) alkyl alkyl alkenoate (generic).

    (a) Chemical substance and significant new uses subject to 
reporting.
    (1) The chemical substance identified generically as alkenoic acid, 
alkyl, carbopolycyclic alkyl ester, polymer with trihalo (trihaloalkyl) 
alkyl alkyl alkenoate (PMN P-22-82) is subject to reporting under this 
section for the significant new uses described in

[[Page 102069]]

paragraph (a)(2) of this section. The requirements of this section do 
not apply to quantities of the substance after they have been entrained 
in dried photoresist.
    (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), 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: 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), (v)(1), (2) and (4), (w)(1), (2) 
and (4), and (x)(1), (2) and (4). It is a significant new use to 
manufacture the substance other than by import into the United States 
(i.e., no domestic manufacture) in a liquid formulation.
    (iv) Disposal. Requirements as specified in Sec.  721.85(a)(1), 
(b)(1), and (c)(1).
    (v) Release to water. Requirements as specified in Sec.  
721.90(a)(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.  721.12063  Polychloroalkene (generic).

    (a) Chemical substance and significant new uses subject to 
reporting.
    (1) The chemical substance identified generically as 
polychloroalkene (PMN P-22-121) 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.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (3) through (6), and (c). When determining which persons 
are reasonably likely to be exposed as required for Sec.  721.63(a)(1) 
and (4), engineering control measures (e.g., enclosure or confinement 
of the operation, general and local ventilation) or administrative 
control measures (e.g., workplace policies and procedures) shall be 
considered and implemented to prevent exposure, where feasible. For 
purposes of Sec.  721.63(a)(5), respirators must provide a National 
Institute for Occupational Safety and Health (NIOSH) assigned 
protection factor (APF) of at least 50.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (f), (g)(1), (3), 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, 
carcinogenicity, 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 OSHA Hazard Communication Standard may 
be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f) and (k). It is a significant new use to 
process, use, load, or unload the substance unless under a gas (e.g., 
nitrogen) blanket or in a closed system except that sampling may occur 
outside the closed system resulting in exposures.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4), where N=0.15.
    (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.  721.12064  Alkanoic acid, trialkyl-, diester with carbomonocycle 
bis(alkyleneoxy)]bis[alkanediol] (generic).

    (a) Chemical substance and significant new uses subject to 
reporting.
    (1) The chemical substance identified generically as alkanoic acid, 
trialkyl-, diester with carbomonocycle bis(alkyleneoxy)]bis[alkanediol] 
(PMN P-22-145) 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), (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: acute toxicity, 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 OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(o). It is a significant new use to use the 
substance in any manner that may generate a spray, mist, vapor, or 
aerosol containing the substance unless the concentration of the 
substance is less than 5.7% by weight.
    (iv) Disposal. Requirements as specified in Sec.  721.85(a)(1), 
(b)(1), and (c)(1).
    (v) Release to water. Requirements as specified in Sec.  
721.90(a)(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.

[[Page 102070]]

    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.12065  Modified Silsesquioxane, alkoxy-terminated (generic).

    (a) Chemical substance and significant new uses subject to 
reporting.
    (1) The chemical substance identified generically as modified 
silsesquioxane, alkoxy-terminated (PMN P-22-175) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (3) through (6), (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 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 OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f). It is a significant new use to use the 
substance unless the concentration of the substance does not exceed 10% 
by weight in formulation.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4), where N=7.
    (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.  721.12066  Vegetable oil, polymer with pimelin ketone, 
oxymethylene and polymethylenepolyphenylene isocyanate (generic).

    (a) Chemical substance and significant new uses subject to 
reporting.
    (1) The chemical substance identified generically as vegetable oil, 
polymer with pimelin ketone, oxymethylene and 
polymethylenepolyphenylene isocyanate (PMN P-23-18) 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: acute toxicity, skin 
irritation, eye irritation, respiratory sensitization, skin 
sensitization, genetic toxicity, carcinogenicity, reproductive 
toxicity, and specific target organ toxicity. Alternative hazard and 
warning statements that meet the criteria of the Globally Harmonized 
System and OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(o). It is a significant new use to 
manufacture, process, or use the substance in any manner that results 
in inhalation exposure to the substance.
    (b) Specific requirements. The provisions of Subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i) are applicable to manufacturers, importers, and 
processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.12067  Silsesquioxanes, 3-mercaptopropyl, polymers with 
silicic acid (H4SiO4) tetra-Et ester, [(trimethylsilyl)oxy]-terminated.

    (a) Chemical substance and significant new uses subject to 
reporting.
    (1) The chemical substance identified as silsesquioxanes, 3-
mercaptopropyl, polymers with silicic acid (H4SiO4) tetra-Et ester, 
[(trimethylsilyl)oxy]-terminated (PMN P-23-20; CASRN 2796383-42-9) 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), (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: skin sensitization 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 
OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k). It is a significant new use to 
manufacture, process, or use the substance in any manner that results 
inhalation exposure.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4), where N=3.
    (b) Specific requirements. The provisions of Subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

[[Page 102071]]

Sec.  721.12068  Castor oil, polymer with dicyclopentadiene, maleic 
anhydride, 2-methyl-1,3-propanediol, 3a,4,7,7a-tetrahydro-2-(2-
hydroxyethyl)-1H-isoindole-1,3(2H)-dione and triethylene glycol.

    (a) Chemical substance and significant new uses subject to 
reporting.
    (1) The chemical substance identified as castor oil, polymer with 
dicyclopentadiene, maleic anhydride, 2-methyl-1,3-propanediol, 
3a,4,7,7a-tetrahydro-2-(2-hydroxyethyl)-1H-isoindole-1,3(2H)-dione and 
triethylene glycol (PMN P-23-36; CASRN 2794200-69-2) 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), (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: 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 OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(o), (y)(1), and (2). It is a significant 
new use to manufacture or process the substance in a manner that 
generates a vapor, mist, aerosol, or dust.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4), where N=27.
    (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.  721.12069  Monoaromatic cyclic alkylene sulfonium fluoroalkyl 
sulfonic acid salt (generic).

    (a) Chemical substance and significant new uses subject to 
reporting.
    (1) The chemical substance identified generically as monoaromatic 
cyclic alkylene sulfonium fluoroalkyl sulfonic acid salt (PMN P-23-37) 
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, 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 
modify the processing or use of 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.  721.12070  Monoaromatic cyclic alkylene sulfonium fluoroalkyl 
sulfonic acid salt (generic).

    (a) Chemical substance and significant new uses subject to 
reporting.
    (1) The chemical substance identified generically as monoaromatic 
cyclic alkylene sulfonium fluoroalkyl sulfonic acid salt (PMN P-23-44) 
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, 
reproductive toxicity, 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 
modify the processing or use of the substance in any way that generates

[[Page 102072]]

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.  721.12071  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-23-80) 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, 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 
modify the processing or use of 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.  721.12072  Aromatic dibenzothiophenium fluoroalkyl carbopolycycle 
sulfonic acid salt (generic).

    (a) Chemical substance and significant new uses subject to 
reporting.
    (1) The chemical substance identified generically as aromatic 
dibenzothiophenium fluoroalkyl carbopolycycle sulfonic acid salt (PMN 
P-23-93) 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, 
reproductive toxicity, 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 
modify the processing or use of 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.  721.12073  Alkanediol, substituted, polymer with 
diisocyanatoalkane, substituted heterocycle-modified (generic).

    (a) Chemical substance and significant new uses subject to 
reporting.
    (1) The chemical substance identified generically as alkanediol, 
substituted, polymer with diisocyanatoalkane, substituted heterocycle-
modified (PMN P-23-64) is subject to reporting under this section for 
the significant new uses described in paragraph (a)(2) of this section. 
The requirements of this section do not apply to quantities of the 
substance after they have been completely reacted or 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: skin sensitization and specific 
target organ toxicity. Alternative hazard and warning statements that 
meet the criteria of the Globally Harmonized System and OSHA

[[Page 102073]]

Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(o), and (y)(1) and (2). It is a 
significant new use to manufacture or process the substance in a manner 
that generates a vapor, mist, aerosol, or dust.
    (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.  721.12074  Halosubstituted carbopolycycle, polymer with 
substituted carbomonocycles and oxybis[alkanol] (generic).

    (a) Chemical substance and significant new uses subject to 
reporting.
    (1) The chemical substance identified generically as 
halosubstituted carbopolycycle, polymer with substituted 
carbomonocycles and oxybis[alkanol] (PMN P-23-72) 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 (6), (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 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: genetic toxicity, 
carcinogenicity, 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 OSHA Hazard Communication Standard may 
be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(o). It is a significant new use to process 
for use or use the substance other than in an enclosed roll-coating 
lithographic printing machine. It is a significant new use to process 
for use or use the substance to a final formulation for coating 
application that exceeds 40% by weight.
    (iv) Disposal. Requirements as specified in Sec.  721.85(a)(2), 
(b)(2), and (c)(2).
    (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.  721.12075  Polymer of benzenedicarboxylic acid, substituted-
benzenedicarboxylic acid, branched-alkyldiol, alkyldiol and 
triisocyanate (generic).

    (a) Chemical substance and significant new uses subject to 
reporting.
    (1) The chemical substance identified generically as polymer of 
benzenedicarboxylic acid, substituted-benzenedicarboxylic acid, 
branched-alkyldiol, alkyldiol and triisocyanate (PMN P-23-94) 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: skin sensitization, respiratory 
sensitization, and specific target organ toxicity. Alternative hazard 
and warning statements that meet the criteria of the Globally 
Harmonized System and OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(o). It is a significant new use to 
manufacture, process, or use the substance in any manner that results 
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.  721.12076  Sulfonium, tricarbocyclic-, alkylcarbomonocyclic-
polyfluoro-heteropolycyclic-alkyl sulfonate (1:1), polymer with 
alkylaryl and carbomonocyclic alkylalkanoate, di-Me 2,2'-(1,2-
diazenediyl)bis[2-alkylalkanoate]-initiated (generic).

    (a) Chemical substance and significant new uses subject to 
reporting.
    (1) The chemical substance identified generically as sulfonium, 
tricarbocyclic-, alkylcarbomonocyclic-polyfluoro-heteropolycyclic-alkyl 
sulfonate (1:1), polymer with alkylaryl and carbomonocyclic 
alkylalkanoate, di-Me 2,2'-(1,2-diazenediyl)bis[2-alkylalkanoate]-
initiated (PMN P-23-172) 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

[[Page 102074]]

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 
modify the processing of 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.

[FR Doc. 2024-29275 Filed 12-16-24; 8:45 am]
BILLING CODE 6560-50-P`