`[Federal Register Volume 89, Number 231 (Monday, December 2, 2024)]
[Proposed Rules]
[Pages 95688-95716]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-27912]



[[Page 95687]]

Vol. 89

Monday,

No. 231

December 2, 2024

Part VI





Environmental Protection Agency





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40 CFR Part 721





Significant New Use Rules on Certain Chemical Substances (24-2.5e); 
Proposed Rule

  Federal Register / Vol. 89 , No. 231 / Monday, December 2, 2024 / 
Proposed Rules  

[[Page 95688]]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 721

[EPA-HQ-OPPT-2024-0077; FRL-12348-01-OCSPP]
RIN 2070-AB27


Significant New Use Rules on Certain Chemical Substances (24-
2.5e)

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 2, 2025.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2024-0077 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: Punam Tyagi, New Chemicals Division 
(7405M), Office of Pollution Prevention and Toxics, Environmental 
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; telephone number: (202) 566-1176; 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: The TSCA-Hotline, ABVI-Goodwill, 422 South 
Clinton Ave., Rochester, NY 14620; telephone number: (202) 554-1404; 
email address: [email protected].

SUPPLEMENTARY INFORMATION:

I. Executive Summary

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

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

B. What action is the Agency taking?

    EPA is proposing SNURs for chemical substances 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 promulgated at 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 2, 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

[[Page 95689]]

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, 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 720, subpart E. Absent a final 
determination or other disposition of the confidentiality claim under 
40 CFR part 2 procedures, EPA is required to keep this information 
confidential. EPA promulgated a procedure 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 for 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.

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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 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 following:
     Human exposure and environmental release that may result 
from the significant new use of the chemical substances.

III. Chemical Substances Subject to These Proposed SNURs

A. What is the designated cutoff date for determining whether the new 
use is ongoing for these chemical substances?

    EPA designates December 2, 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:

[[Page 95691]]

     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).
    Where EPA determined that the PMN substance may present an 
unreasonable risk of injury to human health via inhalation exposure, 
the underlying TSCA Order usually requires that potentially exposed 
employees wear specified respirators unless actual measurements of the 
workplace air show that air-borne concentrations of the PMN substance 
are below a New Chemical Exposure Limit (NCEL). The comprehensive NCELs 
provisions in TSCA Orders include requirements addressing performance 
criteria for sampling and analytical methods, periodic monitoring, 
respiratory protection, and recordkeeping. No comparable NCEL 
provisions currently exist in 40 CFR part 721, subpart B, for SNURs. 
Therefore, for these cases, the individual SNURs in 40 CFR part 721, 
subpart E, will state that persons subject to the SNUR who wish to 
pursue NCELs as an alternative to the 40 CFR 721.63 respirator 
requirements may request to do so under 40 CFR 721.30. EPA expects that 
persons whose 40 CFR 721.30 requests to use the NCELs approach for 
SNURs that are approved by EPA will be required to comply with NCELs 
provisions that are comparable to those contained in the corresponding 
TSCA Order.

C. Which chemical substances are subject to this proposed rule?

    The substances subject to the proposed rules in this document are 
as follows:
PMN Numbers (Proposed CFR Citations): P-16-377 (40 CFR 721.11960) and 
P-16-378 (40 CFR 721.11961)
    Chemical Names: Polyester polyol (generic).
    CASRN: Not available.
    Effective Date of TSCA Order: August 8, 2023.
    Basis for TSCA Order: The PMNs state that the generic (non-
confidential) uses will be as film components. Based on meeting the 
criteria of the PMN substances being insoluble in water, non-reactive, 
respirable, and being high molecular weight polymers, EPA has 
identified concerns for lung effects (lung overload). The Order was 
issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), 
based on a finding that in the absence of sufficient information to 
permit a reasoned evaluation, the substances 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 substances 
in a manner that would result in respirable particle sizes below 10 
microns; 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 testing may be potentially useful to 
characterize the health effects of the PMN substances. Although the 
Order does not require these tests, the Order's restrictions remain in 
effect until the Order is modified or revoked by EPA based on 
submission of this or other relevant information.
PMN Number (Proposed CFR Citation): P-18-346 (40 CFR 721.11962)
    Chemical Name: 2,4,8,10-Tetraoxa-3,9-diphosphaspiro[5.5]undecane, 
3,9-bis-[2-(1-methyl-1- phenylethyl)-4-(1,1,3,3-
tetramethylbutyl)phenoxy]-.
    CASRN: 1507339-21-0.
    Effective Date of TSCA Order: July 25, 2023.
    Basis for TSCA Order: The PMN states that the use will be as an 
antioxidant compounded into various polymers to be used in extrusion 
processes to fabricate articles. Based on submitted test data on the 
PMN substance, EPA has identified concerns for eye irritation and skin 
sensitization. Based on comparison to analogous chemical substances, 
EPA has also identified concerns for neurotoxicity, liver, spleen, 
reproductive, and developmental effects. Based on comparison to 
analogous neutral organic chemicals, EPA predicts toxicity to aquatic 
organisms may occur at concentrations that exceed 18 parts per billion 
(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 release of the PMN substance, or any waste stream 
containing the PMN substance, in surface water concentrations that 
exceed 18 ppb;
     Use of personal protective equipment where there is a 
potential for dermal exposure;
     Use of a NIOSH-certified respirator with an APF of at 
least 50 where there is a potential for inhalation exposure; 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 
neurotoxicity, specific target organ toxicity, reproductive toxicity, 
developmental 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.

[[Page 95692]]

PMN Number (Proposed CFR Citation): P-20-44 (40 CFR 721.11963)
    Chemical Name: 1-Propanamine, 3-methoxy-N,N-dimethyl-.
    CASRN: 20650-07-1.
    Effective Date of Modified TSCA Order: June 14, 2023.
    Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as a curing additive for automotive paint, an 
additive for industrial polyurethane dispersions, a solubilizer for 
high acid value styrene acrylic polymers for use in ink applications, 
for neutralization, solubilization, and stability in commercial 
waterborne and solvent borne coatings and varnishes used for wood, 
metal, composites, and other substrates. Based on submitted test data 
on the new chemical substance, EPA has identified concerns for skin and 
respiratory irritation and serious eye damage. Based on comparison to 
structurally analogous chemical substances, EPA has also identified 
concerns for systemic toxicity, respiratory tract effects, and 
reproductive/developmental toxicity. Based on comparison to analogous 
aliphatic amines, EPA predicts toxicity to aquatic organisms may occur 
at concentrations that exceed 1000 ppb. EPA issued an Order 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. The Order was also issued under TSCA 
sections 5(a)(3)(B)(ii)(II) and 5(e)(1)(A)(ii)(II), based on a finding 
that the substance is or will be produced in substantial quantities and 
that the substance either enters or may reasonably be anticipated to 
enter the environment in substantial quantities, or there is or may be 
significant (or substantial) human exposure to the substance. The 
Order, effective October 1, 2020, required the submitter of P-20-44 to 
submit to EPA the results of certain toxicity testing before any 
manufacturing (which includes import), processing, or use of the PMN 
substance. On May 25, 2021, the PMN submitter provided the results of 
three environmental toxicity studies in accordance with the 
requirements of the Order. EPA reviewed those studies and determined 
the studies to be valid. EPA subsequently modified the terms of the 
Order to mitigate any unreasonable risks to human health and the 
environment and issued a modified Order, effective June 14, 2023. To 
protect against these potential risks, the modified Order requires:
     No use of the PMN substance in consumer products;
     No release of the PMN substance, or any waste stream 
containing the PMN substance, in surface water concentrations that 
exceed 1000 ppb;
     Use of a NIOSH-certified gas/vapor particulate respirator 
with an APF of at least 1000 where there is a potential for inhalation 
exposure or compliance with a NCEL of 1.1388mg/m3 as an 8-hour time-
weighted average to prevent inhalation exposure;
     Use of personal protective equipment where there is a 
potential for dermal exposure; and
     Establishment of a hazard communication program, including 
human health precautionary statements on each label and in the SDS.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially Useful Information: EPA has determined that certain 
information may be potentially useful in support of a request by the 
PMN submitter to modify the Order, or if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that will be 
designated by this SNUR. EPA has determined that the results of skin 
irritation, serious eye damage, 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-21-21 (40 CFR 721.11964)
    Chemical Name: Soybean oil, mixed esters with diethylene glycol, 
phthalic acid and terephthalic acid.
    CASRN: Not available.
    Effective Date of TSCA Order: July 5, 2023.
    Basis for TSCA Order: The PMN states that use will be as a raw 
material to be blended into R-side components of the polyurethane and 
polyisocyanurate industry (specifically used in slabstock/bunstock 
processing of foam). Based on the acid groups, EPA has identified 
concerns for irritation to the skin, eyes, and respiratory tract. Based 
on test data for a feedstock and potential metabolite, diethylene 
glycol, EPA has also identified concerns for systemic (body weight, 
bladder, kidney) and developmental effects. The Order was issued under 
TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a 
finding that in the absence of sufficient information to permit a 
reasoned evaluation, the substance may present an unreasonable risk of 
injury to human health. To protect against these risks, the Order 
requires:
     No use of the PMN substance in consumer products;
     No manufacture, processing, or use of the PMN substance in 
any manner that results in inhalation exposure;
     No release of the PMN substance, or any waste stream 
containing the PMN substance, in surface water concentrations that 
exceed 3000 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, skin irritation, eye damage, and specific target 
organ toxicity testing may be potentially useful to characterize the 
health effects of the PMN substance. Although the Order does not 
require these tests, the Order's restrictions remain in effect until 
the Order is modified or revoked by EPA based on submission of this or 
other relevant information.
PMN Number (Proposed CFR Citation): P-21-151 (40 CFR 721.11965)
    Chemical Name: Soybean oil, epoxidized, polymer with bisphenol A, 
alkyl glycidyl ether, epichlorohydrin, polyethylene glycol and 
trihydroxyalkane (generic).
    CASRN: Not available.
    Effective Date of TSCA Order: August 16, 2023.
    Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be in polyurethane applications. Based on the 
surfactant properties of the PMN substance, EPA has identified concerns 
for lung effects (surfactancy) if inhaled. Based on the potential 
protein crosslinking of multifunctional reactive groups and epoxides 
present in the feedstocks, EPA has also identified concerns for dermal 
and respiratory sensitization. Based on comparison to analogous 
nonionic surfactants, EPA predicts toxicity to aquatic organisms

[[Page 95693]]

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 use of the PMN substance for use in a consumer product;
     No release of the PMN substance, or any waste stream 
containing the PMN substance, in surface water concentrations that 
exceed 140 ppb;
     No processing or use of the PMN substance in a spray 
application;
     Use of personal protective equipment where there is a 
potential for dermal exposure;
     Use of a NIOSH-certified respirator with an APF of at 
least 1,000 where there is a potential for inhalation 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, specific target organ toxicity, 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-21-168 (40 CFR 721.11966)
    Chemical Name: Metal, [heteropolycyclic]-, [[[(hydroxyalkyl)amino] 
sulfonyl]alkyl]sulfonyl(sulfoalkyl)sulfonyl derivs., ammonium sodium 
salts (generic).
    CASRN: Not available.
    Effective Date of TSCA Order: September 22, 2023.
    Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as a colorant. Based on submitted test data 
on the PMN substance, EPA predicts toxicity to aquatic organisms may 
occur at concentrations that exceed 178 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 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 178 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 chronic 
aquatic toxicity testing may be potentially useful to characterize the 
environmental effects of the PMN substance. Although the Order does not 
require these tests, the Order's restrictions remain in effect until 
the Order is modified or revoked by EPA based on submission of this or 
other relevant information.
PMN Number (Proposed CFR Citation): P-21-173 (40 CFR 721.11967)
    Chemical Name: Siloxanes and silicones polyether, polymer with 
aliphatic isocyanate, 2-dimethylaminoethanol and polyglycol ether 
(generic).
    CASRN: Not available.
    Effective Date of TSCA Order: June 29, 2023.
    Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as an additive for finishing of textiles/
fabrics. Based on structure, EPA has identified concerns for lung 
effects due to surfactancy. Based on comparison to analogous chemical 
substances, EPA has also identified concerns for developmental and 
systemic effects. Based on comparison to analogous polycationic 
polymers, 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:
     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;
     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 1 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 
developmental toxicity, 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-21-194 (40 CFR 721.11968)
    Chemical Name: Siloxanes and Silicones, di-Me, 
[gluconoylamino)alkyl]dialkylammonio]- hydroxyalkoxy]alkyl group-
terminated, (salts) (generic).
    CASRN: Not available.
    Effective Date of TSCA Order: September 15, 2023.
    Basis for TSCA Order: The PMN states that the use will be as a 
textile softening agent. Based on the siloxane moieties, EPA has 
identified concerns for lung waterproofing. Based on comparison to 
analogous chemical substances, EPA has also identified concerns for 
irritation to skin and eyes. Based on comparison to analogous 
polycationic polymers, EPA predicts toxicity to 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

[[Page 95694]]

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 as a 
consumer product;
     No release of the PMN substance, or any waste stream 
containing the PMN substance, in surface water concentrations that 
exceed 210 ppb;
     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 
metabolism or pharmacokinetics, skin irritation, eye 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 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-21-202 (40 CFR 721.11969)
    Chemical Name: Sulfonium, carbomonocycle 
bis((trihaloalkyl)carbomonocycle), substituted carbomonocyclic ester 
(generic).
    CASRN: Not available.
    Effective Date of TSCA Order: December 21, 2022.
    Basis for TSCA Order: The PMN states that the generic (non-
confidential) use of the PMN substance will be as an ingredient used in 
the manufacture of photoresist. 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's cation photolysis product will persist in the 
environment for more than six months and estimates a bioaccumulation 
factor of greater than or equal to 1,000. EPA also estimates that the 
PMN substance's cation will persist in the environment for more than 
six months and estimates an unknown bioaccumulation potential based on 
uncertainty about bioaccumulation. Based on the photoreactivity of the 
PMN substance, EPA has identified concerns for photosensitization for 
the cation of the PMN substance. Based on comparison to chemical 
substances analogous to the sulfonium cation of the PMN substance and 
supported by information provided in the SDS, EPA has also identified 
concerns for acute toxicity, irritation to the skin, eyes, and 
respiratory tract, eye corrosion, ocular lethality, neurological 
effects, and systemic effects for the cation. Based on information 
provided in the SDS, EPA has also identified concerns for irritation to 
the skin, eyes, and respiratory tract and neurotoxicity. Based on 
comparison to analogous chemical substances, EPA has also identified 
concerns for mutagenicity for the cation. Based on a potential 
incineration by-product, EPA has also identified concerns for both 
local and systemic effects via inhalation exposure. Based on test data 
for salicylic acid and sodium salicylate, EPA has also identified 
concerns for acute toxicity (mortality), eye irritation, neurotoxicity, 
and reproductive and developmental effects for the anion. Based on 
potential for chelation and irritation based on acid groups, EPA has 
also identified concerns for developmental effects for the anion. 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 or use of the PMN 
substance in any way that generates a vapor, dust, mist, or aerosol in 
a non-enclosed process;
     Use of the PMN substance only for the confidential use 
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 any 
form 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.
PMN Numbers (Proposed CFR Citations): P-21-208 (40 CFR 721.11970), P-
21-209 (40 CFR 721.11971), and P-21-210 (40 CFR 721.11972)
    Chemical Names: Aromatic diacids, polymer with alkyldiacids, 
alkyldiols, benzofurandione, caprolactone and 1,1'-methylenebis[4-
isocyanatobenzene] (generic) (P-21-208), Aromatic diacid, polymer with 
alkyldiacid, alkyldiols, polypropylene glycol, benzofurandione, 
caprolactone and 1,1'-methylenebis[4-isocyanatobenzene] (generic) (P-
21-209), and Aromatic diacids, polymer with alkyldiacids, alkyldiols, 
benzofurandione, polypropylene, alkylhydroxyacid glycolester, 
caprolactone and 1,1'-methylenebis[4- isocyanatobenzene] (generic) (P-
21-210).
    CASRN: Not available.
    Effective Date of TSCA Order: May 26, 2023.
    Basis for TSCA Order: The PMNs state that the generic (non-
confidential) uses will be as adhesives for profile wrapping. Based on 
the structure of the PMN substances, EPA has identified concerns for 
skin sensitization, respiratory sensitization, and genotoxicity. Based 
on test data for a feedstock residual, EPA has also identified concerns 
for acute toxicity, acute neurotoxicity, irritation to the skin, eyes, 
and respiratory tracts, skin sensitization, respiratory sensitization,

[[Page 95695]]

genotoxicity, carcinogenicity, and portal-of-entry systemic, 
reproductive, and developmental effects. Based on information provided 
in the SDSs for the feedstock residual, EPA also identified acute 
toxicity (inhalation), skin sensitization, respiratory sensitization, 
skin irritation, respiratory irritation, and eye corrosion. Based on 
Organisation for Economic Co-operation and Development (OECD Toolbox 
results for the feedstock residual, EPA also identified skin 
sensitization and respiratory sensitization. Based on test data for a 
hydrolysis product of feedstock residual, EPA also identified acute 
toxicity, genotoxicity, carcinogenicity, eye irritation, skin 
irritation, skin sensitization, and systemic and reproductive effects. 
The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 
5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient 
information to permit a reasoned evaluation, the substances may present 
an unreasonable risk of injury to human health. To protect against 
these risks, the Order requires:
     No manufacture, processing, or use of the PMN substances 
in any manner that results in inhalation exposure;
     No release of the PMN substances, or any waste stream 
containing the PMN substances, into waters of the United States;
     No processing for use or use of the PMN substances in 
consumer products;
     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, carcinogenicity, developmental toxicity, serious eye damage, 
genetic toxicity, reproductive toxicity, skin irritation, skin 
sensitization, pulmonary effects, and specific target organ toxicity 
testing may be potentially useful to characterize the health effects of 
the PMN substances. Although the Order does not require these tests, 
the Order's restrictions remain in effect until the Order is modified 
or revoked by EPA based on submission of this or other relevant 
information.
PMN Number (Proposed CFR Citation): P-21-212 (40 CFR 721.11973)
    Chemical Name: Diketone compound metal complex (generic).
    CASRN: Not available.
    Effective Date of TSCA Order: August 2, 2023.
    Basis for TSCA Order: The PMN states that the use will be as a 
luminescent material for security ink. Based on submitted test data, 
EPA has identified concerns for acute toxicity and neurotoxicity. Based 
on the structure as a europium complex, EPA has also identified 
concerns for chelation to nutrient metals. Based on test data for 
analogues of the cation, EPA has also identified concerns for eye 
irritation, irritation/hypersensitivity reactions, and systemic 
effects. Based on test data for analogues of the anion, EPA has also 
identified concerns for acute toxicity, neurotoxicity, and systemic and 
developmental effects. Based on test data for an incineration product, 
EPA has also identified concerns for neurotoxicity, portal-of-entry, 
and systemic effects. Based on comparison to analogous lanthanides or 
rare earth metals, EPA predicts toxicity to aquatic organisms may occur 
at concentrations that exceed 13 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 in exceedance of an 
annual volume of 1,000 kg/yr;
     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, in surface water concentrations that 
exceed 13 ppb;
     The PMN substance, or waste streams containing the PMN 
substance, must be disposed of by hazardous waste incineration;
     Use of personal protective equipment where there is a 
potential for dermal exposure;
     Use of a NIOSH-certified respirator with an APF of at 
least 10 where there is a potential for inhalation exposure; 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, skin irritation/corrosion, eye irritation, specific 
target organ toxicity, pulmonary effects, developmental toxicity, and 
aquatic toxicity testing may be potentially useful to characterize the 
health and environmental effects of the PMN 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-21-214 (40 CFR 721.11974)
    Chemical Name: Poly(oxy-1,2-ethanedlyl), 
.alpha.,.alpha.',.alpha.''-(trialkylamino)tris[omega-hydroxy-, alkyl 
(ester) (generic).
    CASRN: Not available.
    Effective Date of TSCA Order: June 29, 2023.
    Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as a textile finishing agent. Based on the 
structure and intended use as an emulsifier, EPA has identified 
concerns for lung toxicity (surfactant effects), and skin, eye, and 
respiratory tract irritation. Based on test data for alcohol 
ethoxylates, EPA has also identified concerns for developmental and 
systemic effects. Based on comparison to analogous aliphatic amines and 
polycationic polymers, EPA predicts toxicity to aquatic organisms may 
occur at concentrations that exceed 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 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;
     No release of the PMN substance, or any waste stream 
containing the PMN substance, in surface water concentrations that 
exceed 4 ppb; and

[[Page 95696]]

     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, skin irritation, eye irritation, 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-22-18 (40 CFR 721.11975)
    Chemical Name: Substituted polyalkylenepoly, reaction products with 
substituted heteromonocycle substituted heteromonocycle polyalkylene 
derivs. (generic).
    CASRN: Not available.
    Effective Date of TSCA Order: June 23, 2023.
    Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as a component of a lubricant. Based on the 
structure of the PMN substance, EPA has identified concerns for lung 
toxicity via cationic binding. Based on the use of the PMN substance, 
EPA has also identified concerns for surfactant effects on the lungs. 
Based on comparison to analogous chemical substances, EPA has also 
identified concerns for irritation. 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 at a concentration greater than 3%;
     No manufacture, processing, or use of the PMN substance in 
any manner that generates a dust, mist, or aerosol;
     Use of personal protective equipment where there is a 
potential for dermal exposure;
     No use of the PMN substance other than for the 
confidential use listed in the Order; 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 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-22-21 (40 CFR 721.11976)
    Chemical Name: Alkylphosphonic acid, calcium salt (generic).
    CASRN: Not available.
    Effective Date of TSCA Order: June 14, 2023.
    Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as a nucleating agent for polyolefins. Based 
on comparison to analogous chemical substances, EPA has identified 
concerns for systemic (decreased body weight and blood effects) and 
reproductive (male) 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 
and the environment. To protect against these risks, the Order 
requires:
     No use of the PMN substance in consumer products other 
than in plastic articles and other plastic parts;
     Use of personal protective equipment where there is a 
potential for dermal exposure;
     Use of a NIOSH-certified respirator with an APF of at 
least 10 where there is a potential for inhalation exposure; 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 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-22-32 (40 CFR 721.11977)
    Chemical Name: Isocyanic acid, polymethylenepolyphenylene ester, 
polymer with .alpha.-hydro-.omega.-hydroxypoly[oxy(alkanediyl)], 1,1'-
methylenebis[4-isocyanatobenzene] and .alpha.-alkane[.omega.-
hydroxypoly[oxy(alkanediyl)]] (generic).
    CASRN: Not available.
    Effective Date of TSCA Order: October 5, 2023.
    Basis for TSCA Order: The PMN states that the use will be as a 
reactive polymer for use in adhesives and sealants. Based on the weight 
of 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 
analogues of the residuals of the PMN substance, EPA has also 
identified concerns for acute toxicity, irritation to the skin, eyes, 
and respiratory tract, skin sensitization, respiratory sensitization, 
lung effects, systemic effects, reproductive and developmental 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 manufacture, processing, or use of the PMN substance in 
any manner that generates vapor, mist, aerosol, or dust;
     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

[[Page 95697]]

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 
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-22-33 (40 CFR 721.11978)
    Chemical Name: Alkylamine, alkoxysilyl-, hydrolyzed (generic).
    CASRN: Not available.
    Effective Date of TSCA Order: October 5, 2023.
    Basis for TSCA Order: The PMN states that the use will be as an 
adhesion promoter for use in industrial manufacturing operations. Based 
on the amine content, EPA has identified concerns for irritation to the 
skin, eye, and respiratory tract. Based on potential for cationic 
binding to lung membranes, waterproofing, and comparison to analogous 
alkoxysilanes, EPA has also identified concerns for lung effects. Based 
on the expected release of a hydrolysis product, EPA has also 
identified concerns for neurotoxicity and developmental effects. Based 
on comparison to analogous polycationic polymers, 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:
     No manufacture, processing, or use of the PMN substance in 
any manner that generates vapor, mist, aerosol, or dust;
     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;
     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, skin irritation/
corrosion, eye irritation/corrosion, reproductive/developmental 
toxicity, neurotoxicity, 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-22-34 (40 CFR 721.11979)
    Chemical Name: Alkylphosphonic acid, disodium salt (generic).
    CASRN: Not available.
    Effective Date of TSCA Order: June 14, 2023.
    Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as a precursor to a nucleating agent for 
polyolefins. Based on comparison to analogous chemical substances, EPA 
has identified concerns for systemic effects. The Order was issued 
under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a 
finding that in the absence of sufficient information to permit a 
reasoned evaluation, the substance may present an unreasonable risk of 
injury to human health and the environment. 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 
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-22-35 (40 CFR 721.11980)
    Chemical Name: Alkenoic acid, alkanediyl ester, polymer with 
bis(substituted alkyl)-alkanediol polymer with alkylene oxides 
alkenoate, and alkanamine (generic).
    CASRN: Not available.
    Effective Date of TSCA Order: June 1, 2023.
    Basis for TSCA Order: The PMN states that the use will be as a 
component of flexographic ink formulations to improve reactivity when 
cured under LED UV light. Based on comparison to analogous acrylates/
methacrylates and cross-linking potential, EPA has identified concerns 
for irritation to the skin, eyes and respiratory tract, and skin and 
respiratory sensitization. Based on the structure of the PMN substance, 
EPA has also identified concerns for lung effects (cationic binding). 
Based on comparison to analogues of both the low molecular weight 
fraction and the residual, EPA also identified concerns for acute 
toxicity, skin irritation/corrosion, eye irritation/corrosion, 
respiratory tract irritation/corrosion, skin sensitization, 
neurotoxicity, and systemic and reproductive (male) effects. Based on 
comparison to analogous polycationic polymers, 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

[[Page 95698]]

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 consumer products;
     No release of the PMN substance, or any waste stream 
containing the PMN substance, in surface water concentrations that 
exceed 3 ppb;
     Use of a NIOSH-certified particulate respirator with an 
APF of at least 1000 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 aquatic 
toxicity, specific target organ toxicity, pulmonary effects, 
reproductive/developmental toxicity, skin sensitization, skin 
irritation/corrosion, eye irritation/corrosion, acute toxicity, and 
neurotoxicity 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-22-38 (40 CFR 721.11981)
    Chemical Name: Siloxanes and silicones, di-Me, mixed (polyhydro-
substituted heterocyclic) alkyl group and 
[(polyalkylsilyl)substituted]-terminated (generic).
    CASRN: Not available.
    Effective Date of TSCA Order: September 29, 2023.
    Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as an additive. Based on comparison to 
analogous chemical substances, EPA has identified lung, reproductive, 
and systemic effects. The Order was issued under TSCA sections 
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the 
absence of sufficient information to permit a reasoned evaluation, the 
substance may present an unreasonable risk of injury to human health. 
To protect against these risks, the Order requires:
     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;
     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 
pulmonary effects, specific target organ toxicity, and reproductive 
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-22-94 (40 CFR 721.11982)
    Chemical Name: Cadmium tin oxide (Cd2Sn04).
    CASRN: 12185-56-7.
    Effective Date of TSCA Order: October 25, 2023.
    Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be for a contained use as a sputtering material. 
Based on comparison to analogous respirable, poorly soluble 
particulates, EPA has identified concerns for lung effects (lung 
overload and subsequent carcinogenicity). Based on test data for 
components and information provided in the SDS, EPA has also identified 
concerns for acute toxicity, irritation to the skin, eyes, and 
respiratory tract, systemic effects, reproductive and developmental 
effects, genotoxicity, and carcinogenicity. Based on comparison to 
analogous chemical substances, EPA predicts toxicity to aquatic 
organisms may occur at concentrations that exceed 0.2 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 domestic manufacture of the PMN substance (i.e., import 
only);
     No 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;
     No 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; 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 aquatic 
toxicity, sediment toxicity, specific target organ toxicity, acute 
toxicity, pulmonary effects, reproductive toxicity, developmental 
toxicity, skin irritation, eye damage, carcinogenicity, and genetic 
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-22-119 (40 CFR 721.11983) and 
P-22-120 (40 CFR 721.11984)
    Chemical Names: Polyhydroxyalkanoate (generic).
    CASRN: Not applicable.
    Effective Date of TSCA Order: September 29, 2023.
    Basis for TSCA Order: The PMNs state that the generic (non-
confidential) uses will be as resins for packaging materials and for 
use as binders. Based on comparison to analogous chemical substances, 
EPA has identified concerns

[[Page 95699]]

for skin, eye, and respiratory tract irritation. The Order was issued 
under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a 
finding that in the absence of sufficient information to permit a 
reasoned evaluation, the substances may present an unreasonable risk of 
injury to human health. To protect against these risks, the Order 
requires:
    Use of a NIOSH-certified particulate respirator with an APF of at 
least 10 where there is a potential for inhalation exposure;
     Use of personal protective equipment where there is a 
potential for dermal exposure; and
     Establishment of a hazard communication program, including 
human health precautionary statements on each label and in the SDS.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially Useful Information: EPA has determined that certain 
information may be potentially useful in support of a request by the 
PMN submitter to modify the Order, or if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that will be 
designated by this SNUR. EPA has determined that the results of eye 
irritation, pulmonary effects, and skin irritation testing may be 
potentially useful to characterize the health effects of the PMN 
substances. Although the Order does not require these tests, the 
Order's restrictions remain in effect until the Order is modified or 
revoked by EPA based on submission of this or other relevant 
information.
PMN Number (Proposed CFR Citation): P-22-151 (40 CFR 721.11985)
    Chemical Name: Glycolipids, sophorose-contg., yeast-fermented, from 
glycerides and carbohydrates (generic).
    CASRN: Not available.
    Effective Date of TSCA Order: August 29, 2023.
    Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as a surfactant for commercial applications. 
Based on the intended use of the new chemical substance as well as 
submitted surface tension data, EPA has identified concerns for lung 
effects (surfactancy). Based on test data for components and 
information provided in the SDS, EPA has identified concerns for eye 
and respiratory tract irritation and systemic effects. Based on 
comparison to analogous aliphatic amines, EPA predicts toxicity to 
aquatic organisms may occur at concentrations that exceed 550 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;
     No release of the PMN substance, or any waste stream 
containing the PMN substance, in surface water concentrations that 
exceed 550 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 
pulmonary effects, 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-22-178 (40 CFR 721.11986)
    Chemical Name: Aromatic diacid, polymer with alkyldiols, 
hexanedioic acid, benzofurandione, and 1,1'- methylenebis[4-
isocyanatobenzene] (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 an adhesive for lamination. Based on 
comparison to analogous diisocyanates, EPA has identified concerns for 
skin sensitization, respiratory sensitization, and pulmonary toxicity. 
Based on test data for the feedstock residual, EPA has also identified 
concerns for acute toxicity, skin and respiratory sensitization, 
irritation to the skin, eyes, and respiratory tract, and systemic, 
pulmonary, and developmental effects. Based on test data for a 
hydrolysis product of a residual, EPA has also identified concerns for 
genetic toxicity, carcinogenicity, and portal-of-entry, systemic, and 
reproductive 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 manufacture, processing, or use of the PMN substance in 
any manner that results in inhalation exposure;
     No manufacture, processing, or use of the PMN substance 
with residual MDI greater than 5% by weight;
     No processing for use or use of the PMN substance in 
consumer products;
     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, 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 
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-23-13 (40 CFR 721.11987)
    Chemical Name: Phenol, polymer with 4,4'- bis(chloromethyl)-1,1'-
biphenyl.
    CASRN: 208254-04-0.
    Effective Date of TSCA Order: November 2, 2023.
    Basis for TSCA Order: The PMN states that the use will be as an 
epoxy molding compound for electronic devices. Based on comparison to 
analogous chemical substances, EPA has identified concerns for portal-
of-entry effects (GI effects).

[[Page 95700]]

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:
     Manufacture of the PMN substance other than by import into 
the United States (i.e., no domestic manufacture) at concentrations 
equal to or less than the confidential concentration percentage listed 
in the Order;
     No release of the PMN substance, or any waste stream 
containing the PMN substance, in surface water concentrations that 
exceed 260 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 testing may be potentially useful to 
characterize the health effects of the PMN substance. Although the 
Order does not require these tests, the Order's restrictions remain in 
effect until the Order is modified or revoked by EPA based on 
submission of this or other relevant information.
PMN Numbers (Proposed CFR Citations): P-23-49 (40 CFR 721.11988) and P-
23-124 (40 CFR 721.11989)
    Chemical Names: Sulfonium, tricarbocyclic-, 2-aryl- 
polyfluoropolyhydro-alkano -heteropolycycle-alkanesulfonate (1:1), 
polymer with heteroatom substituted aryl and carbomonocyclic 2-alkyl-2-
alkanoate, di-Me 2,2-(1,2-diazenediyl)bis[2-methylpropanoate]-initiated 
(generic) (P-23-49) and Sulfonium, tricabocyclic-, 2-heteroatom-
substituted-(halocarbocyclic)carboxylate (1:1) (generic) (P-23-124).
    CASRN: Not available.
    Effective Date of TSCA Order: September 25, 2023.
    Basis for TSCA Order: The PMNs state that the generic (non-
confidential) use of the PMN substances will be for photolithography. 
Based on the physical/chemical properties of the PMN substances (as 
described in the New Chemical Program's PBT category at 64 FR 60194; 
November 1999) and 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 estimates a 
bioaccumulation factor of greater than or equal to 1,000. Based on the 
presence of 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 of 
the PMN substances. Based on comparison to analogous chemical 
substances, EPA has also identified concerns for genetic toxicity for 
the cation of the PMN substances. Based on the photoreactivity of the 
PMN substances, EPA has also identified concerns for photosensitization 
for the cation of the PMN substances. Based on a structural alert and 
OECD QSAR (Quantitative Structure-Activity Relationship) Toolbox 
results, EPA has also identified concerns for skin sensitization for 
the anion of P-23-124. Based on a potential incineration product, EPA 
has also identified concerns for local and systemic effects for the 
incineration product. 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 of the PMN substances in 
any way that generates a vapor, dust, mist, or aerosol in a non-
enclosed process;
     Use of the PMN substances only for the confidential 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-23-50 (40 CFR 721.11990)
    Chemical Name: Substitutedheterocyclic onium compound, salt with 
heteropolysubstitutedalkyl substitutedtricycloalkanecarboxylate (1:1), 
polymer with 3-ethenylphenol and heterosubstitutedaromaticalkyl 2-
methyl-2-propenoate, di-Me 2,2'-(1,2-diazenediyl)bis[2- 
methylpropanoate]-initiated (generic).
    CASRN: Not available.
    Effective Date of TSCA Order: September 20, 2023.
    Basis for TSCA Order: The PMN states that the generic (non-
confidential) use of the PMN substance will be for contained use for 
microlithography for electronic device manufacturing. Based on the 
physical/chemical properties of the PMN substance (as described in the 
New Chemical Program's PBT category at 64 FR 60194; November 1999) and 
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 1,000. Based on comparison to chemical substances 
analogous to the cation compounds of the PMN substance and supported by 
information provided in the SDS, EPA has identified concerns for acute 
toxicity, irritation to the skin and respiratory tract, eye corrosion, 
neurological effects, and systemic effects for the cation of the PMN 
substance. Based on comparison to analogous chemical substances, EPA 
has also identified concerns for genetic toxicity for the cation of the 
PMN substance. Based on the photoreactivity

[[Page 95701]]

of the PMN substance, EPA has also identified concerns for 
photosensitization for the cation of the PMN substance. Based on a 
potential incineration product, EPA has also identified concerns for 
local and systemic effects for the incineration product. 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 or use of the PMN 
substance in any way that generates a vapor, dust, mist, or aerosol in 
a non-enclosed process;
     Use of the PMN substance only for the confidential use 
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.
PMN Numbers (Proposed CFR Citations): P-23-83 (40 CFR 721.11991), P-23-
125 (40 CFR 721.11992), and P-23-147 (40 CFR 721.11993)
    Chemical Names: Sulfonium, tricarbocyclic-, [polyhydro-alkyl-
(polyfluoro-2-heteroatom substituted)- alkano-heteromonocyclic] alkyl 
ester (1:1) (generic) (P-23-83), Sulfonium, tricarbocyclic-, 
polyfluoropolyhydro-heteroatom substituted carbomonocyclic-2-heteroatom 
substituted carbomonocyclic heteropolycycle-5-alkanesulfonate (1:1) 
(generic) (P-23-125), and Sulfonium, tris(heteroatom-substituted 
carbomonocyclic), salt with polyhydro-polyfluoro-heteroatom-substituted 
alkyl heteropolycyclic-heteroatom-substituted aryl heteroatom-
substituted benzoate (1:1) (generic) (P-23-147).
    CASRN: Not available.
    Effective Date of TSCA Order: October 27, 2023.
    Basis for TSCA Order: The PMNs state that the generic (non-
confidential) use of the PMN substances will be for photolithography. 
Based on the physical/chemical properties of the PMN substances (as 
described in the New Chemical Program's PBT category at 64 FR 60194; 
November 1999) and test data on structurally similar substances, the 
PMN substances are potentially persistent, bioaccumulative, and toxic 
(PBT) chemicals. EPA estimates that the PMN substances will persist in 
the environment for more than six months and estimates a 
bioaccumulation factor of greater than or equal to 1,000. Based on the 
presence of 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 of 
the PMN substances. Based on comparison to analogous chemical 
substances, EPA has also identified concerns for genetic toxicity for 
the sulfonium cation of the PMN substances. Based on the 
photoreactivity of the PMN substances, EPA has also identified concerns 
for photosensitization for the sulfonium cation of the PMN substances. 
Based on comparison to analogous chemical substances, EPA has also 
identified concerns for systemic and developmental effects for the 
anion component of the PMN substances. Based on a potential 
incineration product, EPA has also identified concerns for local and 
systemic effects via inhalation exposure for the incineration product 
of the PMN substances. Based on OECD Toolbox results, EPA also 
identified concerns for skin sensitization for the anion component of 
P-23-147. 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 of the PMN substances in 
any way that generates a vapor, dust, mist, or aerosol in a non-
enclosed process;
     Use of the PMN substances only for the confidential 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-23-104 (40 CFR 721.11994)
    Chemical Name: Sulfonium, carbomonocycle 
bis[(trihaloalkyl)carbomonocycle], disubstituted carbomonocyclic ester 
(generic).
    CASRN: Not available.
    Effective Date of TSCA Order: September 29, 2023.

[[Page 95702]]

    Basis for TSCA Order: The PMN states that the generic (non-
confidential) use of the PMN substance will be an ingredient used in 
the manufacture of photoresist. 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 1,000. Based on the presence of 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 cation of the PMN substance. Based on comparison to 
analogous chemical substances, EPA has also identified concerns for 
genetic toxicity for the cation of the PMN substance. Based on the 
photoreactivity of the PMN substance, EPA has also identified concerns 
for photosensitization for the cation of the PMN substance. Based on a 
potential incineration product, EPA has also identified concerns for 
local and systemic effects for the incineration product. 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 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, 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

[[Page 95703]]

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 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.

    Dated: November 22, 2024.
Mary Elissa Reaves,
Director, Office of Pollution Prevention and Toxics.

    Therefore, for the reasons stated in the preamble, EPA proposes to 
amend 40 CFR chapter I as follows:

PART 721--SIGNIFICANT NEW USES OF CHEMICAL SUBSTANCES

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

    Authority: 15 U.S.C. 2604, 2607, and 2625(c).
0
2. Add Sec. Sec.  721.11960 through 721.11994 to Subpart E to read as 
follows:

Subpart E--Significant New Uses for Specific Chemical Substances

Sec.
* * * * *
721.11960 Polyester polyol (generic).
721.11961 Polyester polyol (generic).
721.11962 2,4,8,10-Tetraoxa-3,9-diphosphaspiro[5.5]undecane, 3,9-
bis-[2-(1-methyl-1- phenylethyl)-4-(1,1,3,3-
tetramethylbutyl)phenoxy]-.
721.11963 1-Propanamine, 3-methoxy-N,N-dimethyl-.
721.11964 Soybean oil, mixed esters with diethylene glycol, phthalic 
acid and terephthalic acid.
721.11965 Soybean oil, epoxidized, polymer with bisphenol A, alkyl 
glycidyl ether, epichlorohydrin, polyethylene glycol and 
trihydroxyalkane (generic).
721.11966 Metal, [heteropolycyclic]-, [[[(hydroxyalkyl)amino] 
sulfonyl]alkyl]sulfonyl(sulfoalkyl)sulfonyl derivs., ammonium sodium 
salts (generic).
721.11967 Siloxanes and silicones polyether, polymer with aliphatic 
isocyanate, 2-dimethylaminoethanol and polyglycol ether (generic).
721.11968 Siloxanes and Silicones, di-Me, 
[gluconoylamino)alkyl]dialkylammonio]- hydroxyalkoxy]alkyl group-
terminated, (salts) (generic).
721.11969 Sulfonium, carbomonocycle 
bis((trihaloalkyl)carbomonocycle), substituted carbomonocyclic ester 
(generic).
721.11970 Aromatic diacids, polymer with alkyldiacids, alkyldiols, 
benzofurandione, caprolactone and 1,1'-methylenebis[4-
isocyanatobenzene] (generic).
721.11971 Aromatic diacid, polymer with alkyldiacid, alkyldiols, 
polypropylene glycol, benzofurandione, caprolactone and 1,1'-
methylenebis[4-isocyanatobenzene] (generic).
721.11972 Aromatic diacids, polymer with alkyldiacids, alkyldiols, 
benzofurandione, polypropylene, alkylhydroxyacid glycolester, 
caprolactone and 1,1'-methylenebis[4- isocyanatobenzene] (generic).
721.11973 Diketone compound metal complex (generic).

[[Page 95704]]

721.11974 Poly(oxy-1,2-ethanedlyl), alpha,alpha'',alpha''-
(trialkylamino)tris[omega-hydroxy-, alkyl (ester) (generic).
721.11975 Substituted polyalkylenepoly, reaction products with 
substituted heteromonocycle substituted heteromonocycle polyalkylene 
derivs (generic).
721.11976 Alkylphosphonic acid, calcium salt (generic).
721.11977 Isocyanic acid, polymethylenepolyphenylene ester, polymer 
with .alpha.-hydro-.omega.w-hydroxypoly[oxy(alkanediyl)], 1,1'-
methylenebis[4-isocyanatobenzene] and .alpha.-alkane[.omega.w-
hydroxypoly[oxy(alkanediyl)]] (generic).
721.11978 Alkylamine, alkoxysilyl-, hydrolyzed (generic).
721.11979 Alkylphosphonic acid, disodium salt (generic).
721.11980 Alkenoic acid, alkanediyl ester, polymer with 
bis(substituted alkyl)-alkanediol polymer with alkylene oxides 
alkenoate, and alkanamine (generic).
721.11981 Siloxanes and silicones, di-Me, mixed (polyhydro-
substituted heterocyclic) alkyl group and 
[(polyalkylsilyl)substituted]-terminated (generic).
721.11982 Cadmium tin oxide (Cd2Sn04).
721.11983 Polyhydroxyalkanoate (generic).
721.11984 Polyhydroxyalkanoate (generic).
721.11985 Glycolipids, sophorose-contg., yeast-fermented, from 
glycerides and carbohydrates (generic).
721.11986 Aromatic diacid, polymer with alkyldiols, hexanedioic 
acid, benzofurandione, and 1,1'- methylenebis[4-isocyanatobenzene] 
(generic).
721.11987 Phenol, polymer with 4,4'- bis(chloromethyl)-1,1'-
biphenyl.
721.11988 Sulfonium, tricarbocyclic-, 2-aryl- polyfluoropolyhydro-
alkano -heteropolycycle-alkanesulfonate (1:1), polymer with 
heteroatom substituted aryl and carbomonocyclic 2-alkyl-2-alkanoate, 
di-Me 2,2-(1,2-diazenediyl)bis[2-methylpropanoate]-initiated 
(generic).
721.11989 Sulfonium, tricabocyclic-, 2-heteroatom-substituted-
(halocarbocyclic)carboxylate (1:1) (generic).
721.11990 Substitutedheterocyclic onium compound, salt with 
heteropolysubstitutedalkyl substitutedtricycloalkanecarboxylate 
(1:1), polymer with 3-ethenylphenol and 
heterosubstitutedaromaticalkyl 2-methyl-2-propenoate, di-Me 2,2'-
(1,2-diazenediyl)bis[2- methylpropanoate]-initiated (generic).
721.11991 Sulfonium, tricarbocyclic-, 2-aryl- polyfluoropolyhydro-
alkano -heteropolycycle-alkanesulfonate (1:1), polymer with 
heteroatom substituted aryl and carbomonocyclic 2-alkyl-2-alkanoate, 
di-Me 2,2-(1,2-diazenediyl)bis[2-methylpropanoate]-initiated 
(generic).
721.11992 Sulfonium, tricarbocyclic-, polyfluoropolyhydro-heteroatom 
substituted carbomonocyclic-2-heteroatom substituted carbomonocyclic 
heteropolycycle-5-alkanesulfonate (1:1) (generic).
721.11993 Sulfonium, tris(heteroatom-substituted carbomonocyclic), 
salt with polyhydro-polyfluoro-heteroatom-substituted alkyl 
heteropolycyclic-heteroatom-substituted aryl heteroatom-substituted 
benzoate (1:1) (generic).
721.11994 Sulfonium, carbomonocycle 
bis[(trihaloalkyl)carbomonocycle], disubstituted carbomonocyclic 
ester (generic).
* * * * *


Sec.  721.11960  Polyester polyol (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
polyester polyol (PMN P-16-377) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are:
    (i) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (f), and (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.
    (ii) Industrial, commercial, and consumer use. It is a significant 
new use to manufacture, process, or use the substance in any manner 
that would result in respirable particle sizes below 10 microns.
    (b) Specific requirements. The provisions of Subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c), and (f) through (i) are applicable to 
manufacturers, importers, and processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11961  Polyester polyol (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
polyester polyol (PMN P-16-378) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are:
    (i) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (f), and (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.
    (ii) Industrial, commercial, and consumer use. It is a significant 
new use to manufacture, process, or use the substance in any manner 
that would result in respirable particle sizes below 10 microns.
    (b) Specific requirements. The provisions of Subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c), and (f) through (i) are applicable to 
manufacturers, importers, and processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11962  2,4,8,10-Tetraoxa-3,9-diphosphaspiro[5.5]undecane, 
3,9-bis-[2-(1-methyl-1- phenylethyl)-4-(1,1,3,3-
tetramethylbutyl)phenoxy]-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 2,4,8,10-tetraoxa-
3,9-diphosphaspiro[5.5]undecane, 3,9-bis-[2-(1-methyl-1- phenylethyl)-
4-(1,1,3,3-tetramethylbutyl)phenoxy]- (PMN P-18-346; CASRN 1507339-21-
0) is subject to reporting under this section for the significant new 
uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (3) through (5), and (c). When determining which persons 
are reasonably likely to be exposed as required for Sec.  721.63(a)(1) 
and (4), engineering control measures (e.g., enclosure or confinement 
of the operation, general and local ventilation) or administrative 
control measures (e.g., workplace policies and procedures) shall be 
considered and implemented to prevent exposure, where feasible. For 
purposes of Sec.  721.63(a)(5), respirators must provide a National 
Institute for Occupational Safety and Health (NIOSH) assigned 
protection factor (APF) of at least 50.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (f), and (g)(1), (3), and (5). For purposes of 
Sec.  721.72(g)(1), this

[[Page 95705]]

substance may cause: skin sensitization, eye irritation, reproductive 
toxicity, and specific target organ toxicity. For purposes of Sec.  
721.72(g)(3), this substance may be: toxic to aquatic life. Alternative 
hazard and warning statements that meet the criteria of the Globally 
Harmonized System and OSHA Hazard Communication Standard may be used.
    (iii) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4), where N=18.
    (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 (h), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11963  1-Propanamine, 3-methoxy-N,N-dimethyl-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 1-propanamine, 3-
methoxy-N,N-dimethyl- (PMN P-20-44; CASRN 20650-07-1) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (3) through (5), (b), and (c). When determining which 
persons are reasonably likely to be exposed as required for Sec.  
721.63(a)(1) and (4), engineering control measures (e.g., enclosure or 
confinement of the operation, general and local ventilation) or 
administrative control measures (e.g., workplace policies and 
procedures) shall be considered and implemented to prevent exposure, 
where feasible. For purposes of Sec.  721.63(a)(5), respirators must 
provide a National Institute for Occupational Safety and Health (NIOSH) 
assigned protection factor (APF) of at least 1000. For purposes of 
Sec.  721.63(b), the concentration is set at 1.0%.
    (A) As an alternative to the respirator requirements in paragraph 
(a)(2)(i) of this section, a manufacturer or processor may choose to 
follow the new chemical exposure limit (NCEL) provision listed in the 
TSCA section 5(e) Order for this substance. The NCEL is 1.1388mg/m3 as 
an 8-hour time weighted average. Persons who wish to pursue NCELs as an 
alternative to Sec.  721.63 respirator requirements may request to do 
so under Sec.  721.30. Persons who Sec.  721.30 requests to use the 
NCELs approach are approved by EPA will be required to follow NCELs 
provisions comparable to those contained in the corresponding TSCA 
section 5(e) Order.
    (B) [Reserved]
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (f), and (g)(1) and (5). For purposes of Sec.  
721.72(e), the concentration is set at 1.0%. For purposes of Sec.  
721.72(g)(1), this substance may cause: skin irritation, serious eye 
damage, reproductive toxicity, and specific target organ toxicity. 
Alternative hazard and warning statements that meet the criteria of the 
Globally Harmonized System and OSHA Hazard Communication Standard may 
be used.
    (iii) Industrial, commercial, and consumer use. Requirements as 
specified in Sec.  721.80(o).
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4), where N=1000.
    (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.  721.11964  Soybean oil, mixed esters with diethylene glycol, 
phthalic acid and terephthalic acid.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as soybean oil, mixed 
esters with diethylene glycol, phthalic acid and terephthalic acid (PMN 
P-21-21) 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) 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) 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, 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 use. Requirements as 
specified in Sec.  721.80(o). It is a significant new use to 
manufacture, process, or use the substance in any manner that results 
in inhalation exposure.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4), where N=3000.
    (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.  721.11965  Soybean oil, epoxidized, polymer with bisphenol A, 
alkyl glycidyl ether, epichlorohydrin, polyethylene glycol and 
trihydroxyalkane (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as soybean 
oil, epoxidized, polymer with bisphenol A, alkyl glycidyl ether, 
epichlorohydrin, polyethylene glycol and trihydroxyalkane (PMN P-21-
151) is subject to reporting under this section for the significant new 
uses described in paragraph (a)(2) of this section. The requirements of 
this section do not apply to quantities of the substance when 
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) through (5), and (c). When determining which 
persons are reasonably likely to be exposed as required for Sec.  
721.63(a)(1) and (4), engineering control measures (e.g.,

[[Page 95706]]

enclosure or confinement of the operation, general and local 
ventilation) or administrative control measures (e.g., workplace 
policies and procedures) shall be considered and implemented to prevent 
exposure, where feasible. For purposes of Sec.  721.63(a)(5), 
respirators must provide a National Institute for Occupational Safety 
and Health (NIOSH) assigned protection factor (APF) of at least 1,000.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (f), and (g)(1) through (3), and (5). For 
purposes of Sec.  721.72(g)(1), this substance may cause: respiratory 
sensitization, skin sensitization, and specific target organ toxicity. 
For purposes of Sec.  721.72(g)(2), do not spray apply. 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 use. Requirements as 
specified in Sec.  721.80(o). It is a significant new use to process or 
use the substance in a spray application.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4), where N=140.
    (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.  721.11966  Metal, [heteropolycyclic]-, [[[(hydroxyalkyl)amino] 
sulfonyl]alkyl]sulfonyl(sulfoalkyl)sulfonyl derivs., ammonium sodium 
salts (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as metal, 
[heteropolycyclic]-, [[[(hydroxyalkyl)amino] 
sulfonyl]alkyl]sulfonyl(sulfoalkyl)sulfonyl derivs., ammonium sodium 
salts (PMN P-21-168) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (f), and (g)(3) and (5). For purposes of Sec.  
721.72(e), the concentration is set at 1.0%. 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.
    (ii) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4), where N=178.
    (b) Specific requirements. The provisions of Subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c), (f) through (h), and (k) are applicable to 
manufacturers, importers, and processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11967  Siloxanes and silicones polyether, polymer with 
aliphatic isocyanate, 2-dimethylaminoethanol and polyglycol ether 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
siloxanes and silicones polyether, polymer with aliphatic isocyanate, 
2-dimethylaminoethanol and polyglycol ether (PMN P-21-173) 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 
embedded into a textile fiber matrix.
    (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 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 use. Requirements as 
specified in Sec.  721.80(o). It is a significant new use to 
manufacture, process, or use the substance in any manner that results 
in inhalation exposure.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4), where N=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.  721.11968  Siloxanes and Silicones, di-Me, 
[gluconoylamino)alkyl]dialkylammonio]- hydroxyalkoxy]alkyl group-
terminated, (salts) (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
siloxanes and silicones, di-Me, [gluconoylamino)alkyl]dialkylammonio]- 
hydroxyalkoxy]alkyl group-terminated, (salts) (PMN P-21-194) is subject 
to reporting under this section for the significant new uses described 
in paragraph (a)(2) of this section. The requirements of this section 
do not apply to quantities of the substance when incorporated into a 
textile.
    (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 purposes of Sec.  
721.72(e), the concentration is set at 1.0%. For purposes of Sec.  
721.72(g)(1), this

[[Page 95707]]

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 use. Requirements as 
specified in Sec.  721.80(o). It is a significant new use to 
manufacture, process, or use the substance in any manner that results 
in the generation of a vapor, mist, dust, or aerosol.
    (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.  721.11969  Sulfonium, carbomonocycle 
bis((trihaloalkyl)carbomonocycle), substituted carbomonocyclic ester 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
sulfonium, carbomonocycle bis((trihaloalkyl)carbomonocycle), 
substituted carbomonocyclic ester (PMN P-21-202) 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), and (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, unless in sealed 
containers weighing 5 kilograms or less. It is a significant new use to 
process the substance in any way that generates dust, mist, or aerosol 
in a non-enclosed process. It is a significant new use to manufacture 
the substance longer than 9 months.
    (b) Specific requirements. The provisions of Subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i) are applicable to manufacturers, importers, and 
processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11970  Aromatic diacids, polymer with alkyldiacids, 
alkyldiols, benzofurandione, caprolactone and 1,1'-methylenebis[4-
isocyanatobenzene] (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
aromatic diacids, polymer with alkyldiacids, alkyldiols, 
benzofurandione, caprolactone and 1,1'-methylenebis[4-
isocyanatobenzene] (PMN P-21-208) 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), and (g)(1) and (5). For purposes of Sec.  
721.72(g)(1), this substance may cause: acute toxicity, skin 
irritation, serious eye damage, 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 use. Requirements as 
specified in Sec.  721.80(o). It is a significant new use to 
manufacture, process, or use the substance in any manner that results 
in inhalation exposure.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(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.  721.11971  Aromatic diacid, polymer with alkyldiacid, alkyldiols, 
polypropylene glycol, benzofurandione, caprolactone and 1,1'-
methylenebis[4-isocyanatobenzene] (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
aromatic diacid, polymer with alkyldiacid, alkyldiols, polypropylene 
glycol, benzofurandione, caprolactone and 1,1'-methylenebis[4-
isocyanatobenzene] (PMN P-21-209) 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

[[Page 95708]]

determining which persons are reasonably likely to be exposed as 
required for Sec.  721.63(a)(1), engineering control measures (e.g., 
enclosure or confinement of the operation, general and local 
ventilation) or administrative control measures (e.g., workplace 
policies and procedures) shall be considered and implemented to prevent 
exposure, where feasible.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (f), and (g)(1) and (5). For purposes of Sec.  
721.72(g)(1), this substance may cause: acute toxicity, skin 
irritation, serious eye damage, 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 use. Requirements as 
specified in Sec.  721.80(o). It is a significant new use to 
manufacture, process, or use the substance in any manner that results 
in inhalation exposure.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(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.  721.11972  Aromatic diacids, polymer with alkyldiacids, 
alkyldiols, benzofurandione, polypropylene, alkylhydroxyacid 
glycolester, caprolactone and 1,1'-methylenebis[4- isocyanatobenzene] 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
aromatic diacids, polymer with alkyldiacids, alkyldiols, 
benzofurandione, polypropylene, alkylhydroxyacid glycolester, 
caprolactone and 1,1'-methylenebis[4- isocyanatobenzene] (PMN P-21-210) 
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), and (f), and (g)(1) and (5). For purposes of 
Sec.  721.72(g)(1), this substance may cause: acute toxicity, skin 
irritation, serious eye damage, 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 use. Requirements as 
specified in Sec.  721.80(o). It is a significant new use to 
manufacture, process, or use the substance in any manner that results 
in inhalation exposure.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(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.  721.11973  Diketone compound metal complex (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
diketone compound metal complex (PMN P-21-212) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section. The requirements of this section do not apply 
to quantities of the substance when completely entrained in dried/cured 
ink.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (3) through (5), and (c). When determining which persons 
are reasonably likely to be exposed as required for Sec.  721.63(a)(1) 
and (4), engineering control measures (e.g., enclosure or confinement 
of the operation, general and local ventilation) or administrative 
control measures (e.g., workplace policies and procedures) shall be 
considered and implemented to prevent exposure, where feasible. For 
purposes of Sec.  721.63(a)(5), respirators must provide a National 
Institute for Occupational Safety and Health (NIOSH) assigned 
protection factor (APF) of at least 10.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (f), and (g)(1), (3), and (5). For purposes of 
Sec.  721.72(g)(1), this substance may cause: acute toxicity, skin 
corrosion, serious eye damage, skin irritation, eye irritation, skin 
sensitization, reproductive toxicity, and specific target organ 
toxicity. For purposes of Sec.  721.72(g)(3), this substance may be: 
toxic to aquatic life. Alternative hazard and warning statements that 
meet the criteria of the Globally Harmonized System and OSHA Hazard 
Communication Standard may be used.
    (iii) Industrial, commercial, and consumer use. Requirements as 
specified in Sec.  721.80(o) and (t). It is a significant new use to 
manufacture the substance in excess of an annual volume of 1,000 kg/yr.
    (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)(4), (b)(4), and (c)(4), where N=13.
    (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.  721.11974  Poly(oxy-1,2-ethanedlyl), alpha,alpha',alpha''-
(trialkylamino)tris[omega-hydroxy-, alkyl (ester) (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified

[[Page 95709]]

generically as poly(oxy-1,2-ethanedlyl), alpha,alpha',alpha''-
(trialkylamino)tris[omega-hydroxy-, alkyl (ester) (PMN P-21-214) 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 embedded into a textile fiber matrix.
    (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 purposes of Sec.  
721.72(e), the concentration is set at 1.0%. For purposes of Sec.  
721.72(g)(1), this substance may cause: skin irritation, eye 
irritation, reproductive toxicity, and specific target organ toxicity. 
For purposes of Sec.  721.72(g)(3), this substance may be: toxic to 
aquatic life. Alternative hazard and warning statements that meet the 
criteria of the Globally Harmonized System and OSHA Hazard 
Communication Standard may be used.
    (iii) Industrial, commercial, and consumer use. Requirements as 
specified in Sec.  721.80(o). It is a significant new use to 
manufacture, process, or use the substance in any manner that results 
in inhalation exposure.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4), where N=4.
    (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.  721.11975  Substituted polyalkylenepoly, reaction products with 
substituted heteromonocycle substituted heteromonocycle polyalkylene 
derivs (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
substituted polyalkylenepoly, reaction products with substituted 
heteromonocycle substituted heteromonocycle polyalkylene derivs. (PMN 
P-22-18) 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) 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. 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 use. Requirements as 
specified in Sec.  721.80(k). It is a significant new use to process 
for use or use the substance in consumer products at a concentration 
greater than 3%. It is a significant new use to manufacture, process, 
or use the substance in any manner that results in a dust, mist, or 
aerosol.
    (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.  721.11976  Alkylphosphonic acid, calcium salt (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
alkylphosphonic acid, calcium salt (PMN P-22-21) 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 fully 
reacted, cured, destroyed, or entrained in a polymer matrix.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (3) through (5), (b), and (c). When determining which 
persons are reasonably likely to be exposed as required for Sec.  
721.63(a)(1) and (4), engineering control measures (e.g., enclosure or 
confinement of the operation, general and local ventilation) or 
administrative control measures (e.g., workplace policies and 
procedures) shall be considered and implemented to prevent exposure, 
where feasible. For purposes of Sec.  721.63(a)(5), respirators must 
provide a National Institute for Occupational Safety and Health (NIOSH) 
assigned protection factor (APF) of at least 10. For purposes of Sec.  
721.63(b), the concentration is set at 1.0%.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (f), and (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 use. It is a significant 
new use to use the substance in consumer products other than in plastic 
articles and other plastic parts.
    (b) Specific requirements. The provisions of Subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i) are applicable to manufacturers, importers, and 
processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

[[Page 95710]]

Sec.  721.11977  Isocyanic acid, polymethylenepolyphenylene ester, 
polymer with .alpha.-hydro-.omega.- hydroxypoly[oxy(alkanediyl)], 1,1'-
methylenebis[4-isocyanatobenzene] and .alpha.-alkane[.omega.- 
hydroxypoly[oxy(alkanediyl)]] (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
isocyanic acid, polymethylenepolyphenylene ester, polymer with .alpha.-
hydro-.omega.-hydroxypoly[oxy(alkanediyl)], 1,1'-methylenebis[4-
isocyanatobenzene] and .alpha.-alkane[.omega.-
hydroxypoly[oxy(alkanediyl)]] (PMN P-22-32) 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), and (g)(1) and (5). For purposes of Sec.  
721.72(g)(1), this substance may cause: acute toxicity (residual), skin 
irritation (residual), eye irritation (residual), skin sensitization, 
respiratory sensitization, genetic toxicity (residual), carcinogenicity 
(residual), reproductive toxicity (residual), 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 use. Requirements as 
specified in Sec.  721.80(o). It is a significant new use to 
manufacture, process, or use the substance in any manner that results 
in a vapor, mist, aerosol, or dust.
    (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.  721.11978  Alkylamine, alkoxysilyl-, hydrolyzed (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
alkylamine, alkoxysilyl-, hydrolyzed (PMN P-22-33) 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), and (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, specific target organ toxicity, and reproductive 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 use. Requirements as 
specified in Sec.  721.80(o). It is a significant new use to 
manufacture, process, or use the substance in any manner that results 
in a vapor, mist, aerosol, or dust.
    (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.  721.11979  Alkylphosphonic acid, disodium salt (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
alkylphosphonic acid, disodium salt (PMN P-22-34) 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 fully 
reacted, cured, destroyed, or entrained in a polymer matrix.
    (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) 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 use. Requirements as 
specified in Sec.  721.80(o). It is a significant new use to 
manufacture, process, or use the substance in any manner that results 
in inhalation exposure.
    (b) Specific requirements. The provisions of Subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i) are applicable to manufacturers, importers, and 
processors of this substance.

[[Page 95711]]

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


Sec.  721.11980  Alkenoic acid, alkanediyl ester, polymer with 
bis(substituted alkyl)-alkanediol polymer with alkylene oxides 
alkenoate, and alkanamine (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
alkenoic acid, alkanediyl ester, polymer with bis(substituted alkyl)-
alkanediol polymer with alkylene oxides alkenoate, and alkanamine (PMN 
P-22-35) is subject to reporting under this section for the significant 
new uses described in paragraph (a)(2) of this section. The 
requirements of this section do not apply to quantities of the 
substance after they have been completely reacted or cured.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (3) through (5), 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 1000.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (f), and (g)(1), (3), and (5). For purposes of 
Sec.  721.72(g)(1), this substance may cause: acute toxicity, skin 
irritation, eye irritation, skin corrosion, serious eye damage, 
respiratory sensitization, skin sensitization, reproductive toxicity, 
and specific target organ toxicity. For purposes of Sec.  721.72(g)(3), 
this substance may be: toxic to aquatic life. Alternative hazard and 
warning statements that meet the criteria of the Globally Harmonized 
System and OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer use. Requirements as 
specified in Sec.  721.80(o).
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4), where N=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.


Sec.  721.11981  Siloxanes and silicones, di-Me, mixed (polyhydro-
substituted heterocyclic) alkyl group- and 
[(polyalkylsilyl)substituted]-terminated (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
siloxanes and silicones, di-Me, mixed (polyhydro-substituted 
heterocyclic) alkyl group- and [(polyalkylsilyl)substituted]-terminated 
(PMN P-22-38) 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), and (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 use. Requirements as 
specified in Sec.  721.80(o). It is a significant new use to 
manufacture, process, or use the substance in any manner that results 
in inhalation exposure.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(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.  721.11982  Cadmium tin oxide (Cd2Sn04).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as cadmium tin oxide 
(Cd2Sn04) (PMN P-22-94; CASRN 12185-56-7) 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.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1) and (3), (b), and (c). When determining which persons are 
reasonably likely to be exposed as required for Sec.  721.63(a)(1), 
engineering control measures (e.g., enclosure or confinement of the 
operation, general and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures) shall be considered 
and implemented to prevent exposure, where feasible. For purposes of 
Sec.  721.63(b), the concentration is set at 0.1%.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (f), and (g)(1), (3), and (5). For purposes of Sec.  
721.72(e), the concentration is set at 0.1%. For purposes of Sec.  
721.72(g)(1), this substance may cause: skin irritation, eye 
irritation, genetic toxicity, specific target organ toxicity, acute 
toxicity, reproductive toxicity, and carcinogenicity. For purposes of 
Sec.  721.72(g)(3), this substance may be: toxicity 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 use. Requirements as 
specified in Sec.  721.80(f) and (k). It is a significant new use to 
manufacture, process, or use the substance in any manner that results 
in inhalation exposure.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of Subpart A of this part

[[Page 95712]]

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.  721.11983  Polyhydroxyalkanoate (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
polyhydroxyalkanoate (PMN P-22-119) 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 plastic 
or when completely reacted or cured or when incorporated into an 
article.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (3) through (5), (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), and (g)(1) and (5). For purposes of Sec.  
721.72(e), the concentration is set at 1.0%. For purposes of Sec.  
721.72(g)(1), this substance may cause: skin irritation, eye 
irritation, and specific target organ toxicity. Alternative hazard and 
warning statements that meet the criteria of the Globally Harmonized 
System and OSHA Hazard Communication Standard may be used.
    (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 (h) 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.  721.11984  Polyhydroxyalkanoate (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
polyhydroxyalkanoate (PMN P-22-120) 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 plastic 
or when completely reacted or cured or when incorporated into an 
article.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (3) through (5), (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), and (g)(1) and (5). For purposes of Sec.  
721.72(e), the concentration is set at 1.0%. For purposes of Sec.  
721.72(g)(1), this substance may cause: skin irritation, eye 
irritation, and specific target organ toxicity. Alternative hazard and 
warning statements that meet the criteria of the Globally Harmonized 
System and OSHA Hazard Communication Standard may be used.
    (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 (h) 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.  721.11985  Glycolipids, sophorose-contg., yeast-fermented, from 
glycerides and carbohydrates (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
glycolipids, sophorose-contg., yeast-fermented, from glycerides and 
carbohydrates (PMN P-22-151) 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 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: 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 use. Requirements as 
specified in Sec.  721.80(o). It is a significant new use to 
manufacture, process, or use the substance in any manner that results 
in inhalation exposure.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4), where N=550.
    (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 95713]]

Sec.  721.11986  Aromatic diacid, polymer with alkyldiols, hexanedioic 
acid, benzofurandione, and 1,1'- methylenebis[4-isocyanatobenzene] 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
aromatic diacid, polymer with alkyldiols, hexanedioic acid, 
benzofurandione, and 1,1'- methylenebis[4-isocyanatobenzene] (PMN P-22-
178) 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), and (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 use. Requirements as 
specified in Sec.  721.80(o). It is a significant new use to 
manufacture, process, or use the substance in any manner that results 
in inhalation exposure. It is a significant new use to manufacture, 
process, or use the substance with residual MDI greater than 5% by 
weight.
    (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.  721.11987  Phenol, polymer with 4,4'- bis(chloromethyl)-1,1'-
biphenyl.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as phenol, polymer 
with 4,4'- bis(chloromethyl)-1,1'-biphenyl (PMN P-23-13; CASRN 208254-
04-0) is subject to reporting under this section for the significant 
new uses described in paragraph (a)(2) of this section. The 
requirements of this section do not apply to quantities of the 
substance after they have been completely reacted or cured.
    (2) The significant new uses are:
    (i) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (f), and (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.
    (ii) Industrial, commercial, and consumer use. It is a significant 
new use to manufacture the substance other than by import into the 
United States (i.e., no domestic manufacture) at concentrations equal 
to or greater than the confidential concentration percentage listed in 
the Order.
    (iii) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4), where N=260.
    (b) Specific requirements. The provisions of Subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c), (f) through (i), and (k) are applicable to 
manufacturers, importers, and processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11988  Sulfonium, tricarbocyclic-, 2-aryl- 
polyfluoropolyhydro-alkano -heteropolycycle-alkanesulfonate (1:1), 
polymer with heteroatom substituted aryl and carbomonocyclic 2-alkyl-2-
alkanoate, di-Me 2,2-(1,2-diazenediyl)bis[2-methylpropanoate]-initiated 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
sulfonium, tricarbocyclic-, 2-aryl- polyfluoropolyhydro-alkano -
heteropolycycle-alkanesulfonate (1:1), polymer with heteroatom 
substituted aryl and carbomonocyclic 2-alkyl-2-alkanoate, di-Me 2,2-
(1,2-diazenediyl)bis[2-methylpropanoate]-initiated (PMN P-23-49) 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 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 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

[[Page 95714]]

provisions of Sec.  721.185 apply to this section.


Sec.  721.11989  Sulfonium, tricabocyclic-, 2-heteroatom-substituted-
(halocarbocyclic)carboxylate (1:1) (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
sulfonium, tricabocyclic-, 2-heteroatom-substituted-
(halocarbocyclic)carboxylate (1:1) (generic) (PMN P-23-124) is subject 
to reporting under this section for the significant new uses described 
in paragraph (a)(2) of this section. The requirements of this section 
do not apply to quantities of the substance after they have been 
completely reacted or adhered (during photolithographic processes) onto 
a semiconductor wafer surface or similar manufactured article used in 
the production of semiconductor technologies.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (2)(i) and (iii), (3), and (c). When determining which 
persons are reasonably likely to be exposed as required for Sec.  
721.63(a)(1), engineering control measures (e.g., enclosure or 
confinement of the operation, general and local ventilation) or 
administrative control measures (e.g., workplace policies and 
procedures) shall be considered and implemented to prevent exposure, 
where feasible.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (f), and (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 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.  721.11990  Substitutedheterocyclic onium compound, salt with 
heteropolysubstitutedalkyl substitutedtricycloalkanecarboxylate (1:1), 
polymer with 3-ethenylphenol and heterosubstitutedaromaticalkyl 2-
methyl-2-propenoate, di-Me 2,2'-(1,2-diazenediyl)bis[2- 
methylpropanoate]-initiated (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
substitutedheterocyclic onium compound, salt with 
heteropolysubstitutedalkyl substitutedtricycloalkanecarboxylate (1:1), 
polymer with 3-ethenylphenol and heterosubstitutedaromaticalkyl 2-
methyl-2-propenoate, di-Me 2,2'-(1,2-diazenediyl)bis[2- 
methylpropanoate]-initiated (PMN P-23-50) 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), and (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 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.  721.11991  Sulfonium, tricarbocyclic-, 2-aryl- 
polyfluoropolyhydro-alkano -heteropolycycle-alkanesulfonate (1:1), 
polymer with heteroatom substituted aryl and carbomonocyclic 2-alkyl-2-
alkanoate, di-Me 2,2-(1,2-diazenediyl)bis[2-methylpropanoate]-initiated 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
sulfonium, tricarbocyclic-, 2-aryl- polyfluoropolyhydro-alkano -
heteropolycycle-alkanesulfonate (1:1), polymer with heteroatom 
substituted aryl and carbomonocyclic 2-alkyl-2-alkanoate, di-Me 2,2-
(1,2-diazenediyl)bis[2-methylpropanoate]-initiated (PMN P-23-83) 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

[[Page 95715]]

considered and implemented to prevent exposure, where feasible.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (f), and (g)(1), (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.


Sec.  721.11992  Sulfonium, tricarbocyclic-, polyfluoropolyhydro-
heteroatom substituted carbomonocyclic-2-heteroatom substituted 
carbomonocyclic heteropolycycle-5-alkanesulfonate (1:1) (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
sulfonium, tricarbocyclic-, polyfluoropolyhydro-heteroatom substituted 
carbomonocyclic-2-heteroatom substituted carbomonocyclic 
heteropolycycle-5-alkanesulfonate (1:1) (PMN P-23-125) 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), and (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.


Sec.  721.11993  Sulfonium, tris(heteroatom-substituted 
carbomonocyclic), salt with polyhydro-polyfluoro-heteroatom-substituted 
alkyl heteropolycyclic-heteroatom-substituted aryl heteroatom-
substituted benzoate (1:1) (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
sulfonium, tris(heteroatom-substituted carbomonocyclic), salt with 
polyhydro-polyfluoro-heteroatom-substituted alkyl heteropolycyclic-
heteroatom-substituted aryl heteroatom-substituted benzoate (1:1) (PMN 
P-23-147) 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), and (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.

[[Page 95716]]

Sec.  721.11994  Sulfonium, carbomonocycle 
bis[(trihaloalkyl)carbomonocycle], disubstituted carbomonocyclic ester 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
sulfonium, carbomonocycle bis[(trihaloalkyl)carbomonocycle], 
disubstituted carbomonocyclic ester (PMN P-23-104) 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), and (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 
process the substance in any way that generates dust, mist, or aerosol 
in a non-enclosed process. It is a significant new use to manufacture 
the substance longer than 9 months.
    (b) Specific requirements. The provisions of Subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i) are applicable to manufacturers, importers, and 
processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

[FR Doc. 2024-27912 Filed 11-29-24; 8:45 am]
BILLING CODE 6560-50-P`