
[Federal Register Volume 88, Number 241 (Monday, December 18, 2023)]
[Rules and Regulations]
[Pages 87346-87358]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-27653]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 9 and 721

[EPA-HQ-OPPT-2022-0462; FRL-10183-03-OCSPP]
RIN 2070-AB27


Significant New Use Rules on Certain Chemical Substances (22-
2.5e)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is issuing significant new use rules (SNURs) under the 
Toxic Substances Control Act (TSCA) for 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 designated as a significant new use by this rule to notify EPA 
at least 90 days before commencing that activity. The required 
notification initiates EPA's evaluation of the use, under the 
conditions of use for that chemical substance, within the applicable 
review period. Persons may not commence manufacture or processing for 
the significant new use until they have submitted a Significant New Use 
Notice (SNUN), and EPA has conducted a review of the notice, made an 
appropriate determination on the notice, and has taken such actions as 
are required by that determination.

DATES: This rule is effective on February 16, 2024. For purposes of 
judicial review, this rule shall be promulgated at 1 p.m. (EST) on 
January 2, 2024.

ADDRESSES: The docket for this action, identified under docket 
identification (ID) number EPA-HQ-OPPT-2022-0462, is available online 
at https://www.regulations.gov or in person at the Office of Pollution 
Prevention and Toxics Docket (OPPT Docket) in the Environmental 
Protection Agency Docket Center (EPA/DC). Please review the visitor 
instructions and additional information about the docket available at 
https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: 
    For technical information contact: 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 contact: 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 four TSCA section 5(a)(2) factors 
listed in Unit II.A.1.

B. What action is the Agency taking?

    EPA is finalizing these SNURs under TSCA section 5(a)(2) for 
certain chemical substances that were the subject of PMNs. This 
document addresses final rules for 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 final 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).
    Previously, EPA proposed SNURs for these chemical substances in the 
Federal Register of October 31, 2022 (87 FR 65548) (FRL-10183-02-
OCSPP). The docket includes information considered by the Agency in 
developing the proposed and final rules, including public comments and 
EPA's responses to the public comments received. The proposed SNURs for 
certain chemical substances not included in this Federal Register 
document will be addressed in a future Federal Register document.

C. Why is the Agency taking this action?

    The Agency is issuing these SNURs to ensure that EPA receives 
timely advanced notice of any future manufacturing (including 
importing) or processing of the chemical substances subject to these 
proposed SNURs for uses identified as significant new uses, and to 
ensure that an appropriate determination (relevant to the potential 
risks associated with such manufacturing (including importing), 
processing, distribution in commerce, use and disposal) has been issued 
prior to the commencement of such manufacturing (including importing) 
or processing. The SNURs are necessary to ensure that manufacturing 
(including import) or processing for significant new uses cannot 
proceed until EPA has responded to the planned new use circumstances by 
taking the required actions under TSCA sections 5(e) or 5(f) in the 
event that EPA determines that:
    (1) The significant new use presents an unreasonable risk under the 
conditions of use (without consideration of costs or other non-risk 
factors, and including an unreasonable risk to a potentially exposed or 
susceptible subpopulation (PESS) identified as relevant by EPA);
    (2) The information available to EPA is insufficient to permit a 
reasoned evaluation of the health and environmental effects of the 
significant new use;
    (3) In the absence of sufficient information, the manufacturing 
(including importing), processing, distribution in commerce, use, or 
disposal of the substance, or any combination of such activities, may 
present an unreasonable risk (without consideration of costs or other 
non-risk factors, and including an unreasonable risk to a PESS 
identified as relevant by EPA); or
    (4) There is substantial production and sufficient potential for 
environmental release or human exposure (as defined in TSCA section 
5(a)(3)(B)(ii)(II)).
    For manufacturing (including importing) or processing for the 
significant new use to proceed after EPA has made one of these four 
determinations, EPA must take actions under TSCA sections 5(e) or 5(f) 
to protect health and the environment. However, EPA may also determine 
that the significant new use is not likely to present an unreasonable 
risk under TSCA section 5(a)(3)(C), after which manufacturing 
(including importing) or

[[Page 87347]]

processing for the significant new use may proceed.
    The rationale and objectives for this SNUR are further explained in 
Unit II.B.

D. Does this action apply to me?

1. General Applicability
    This action may apply to you if you manufacture (defined by statute 
to include import), process, or use the chemical substances addressed 
in this Federal Register document. The following list of North American 
Industrial Classification System (NAICS) codes is not intended to be 
exhaustive, but rather provides a guide to help readers determine 
whether this document applies to them. Potentially affected entities 
may include:
     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 affect certain entities through pre-existing 
import certification and export notification rules under TSCA. Chemical 
importers are subject to the TSCA section 13 (15 U.S.C. 2612), import 
provisions promulgated at 19 CFR 12.118 through 12.127 (see also 19 CFR 
127.28), and the EPA policy in support of import certification at 40 
CFR part 707, subpart B. Chemical importers must certify that the 
shipment of the chemical substance complies with all applicable rules 
and Orders under TSCA, including regulations issued under TSCA sections 
5, 6, 7 and Title IV.
    In addition, pursuant to 40 CFR 721.20, this action may also apply 
to any persons who export or intend to export a chemical substance 
identified in this document is subject to the export notification 
provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) (see 40 CFR 
721.20), and must comply with the export notification requirements in 
40 CFR part 707, subpart D.

E. What are the estimated incremental impacts of this action?

    EPA has evaluated the potential costs of establishing SNUR 
reporting requirements for potential manufacturers (including 
importers) and processors of the chemical substances included in these 
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 $26,700 per SNUN 
submission for large business submitters and $11,000 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 $19,020 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 $3,300 (40 CFR 
700.45(c)(1)(ii) and (d)) per fiscal year 2022. The costs of submission 
for SNUNs will not be incurred by any company unless a company decides 
to pursue a significant new use as defined in these SNURs. 
Additionally, these estimates reflect the costs and fees as they are 
known at the time of this rulemaking.
2. Estimated Costs for Export Notifications
    EPA has also evaluated the potential costs associated with the 
export notification requirements under TSCA section 12(b) and the 
implementing regulations at 40 CFR part 707, subpart D. For persons 
exporting a substance that is the subject of a SNUR, a one-time notice 
to EPA must be provided for the first export or intended export to a 
particular country. The total costs of export notification will vary by 
chemical, depending on the number of required notifications (i.e., the 
number of countries to which the chemical is exported). While EPA is 
unable to make any estimate of the likely number of export 
notifications for the chemical substances covered by these SNURs, as 
stated in the accompanying economic analysis, the estimated cost of the 
export notification requirement on a per unit basis is approximately 
$106.

II. Background

A. Significant New Use Determination

1. 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 addition to the factors enumerated in TSCA section 5(a)(2), the 
statute authorizes EPA to consider any other relevant factors.
2. Scientific Standards, Evidence, and Available Information
    EPA has used reasonably available information, as well as technical 
procedures, measures, methods, protocols, methodologies, and models 
consistent with the best available science, as applicable. These 
information sources supply information relevant to whether a particular 
use would be a significant new use, based on relevant factors including 
those listed under TSCA section 5(a)(2).
    The clarity and completeness of the data, assumptions, methods, 
quality assurance, and analyses employed in EPA's decision are 
documented, as applicable and to the extent necessary for purposes of 
the proposed SNURs, in the references cited throughout the preamble of 
this proposed rule. The extent to which the various information, 
procedures, measures, methods, protocols, methodologies or models used 
in EPA's decision have been subject to independent verification or peer 
review is adequate to justify their use, collectively, in the record 
for a significant new use rule.
3. Determination for These Chemical Substances
    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 possible uses of these chemical substances, in the 
context of the four TSCA section 5(a)(2) factors listed in Unit II.A.1.
    These SNURs include PMN substances that are subject to Orders 
issued under TSCA section 5(e)(1)(A), as required by the determinations 
made under TSCA section 5(a)(3)(B). The TSCA Orders require protective 
measures to limit exposures or otherwise mitigate the potential 
unreasonable risk. The SNURs identify significant new uses as 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).

[[Page 87348]]

B. Rationale and Objectives

1. Rationale
    During review of the PMNs submitted for the chemical substances 
that are subject to these 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. The basis for such 
findings is outlined in Unit V. of the proposed rule for each chemical. 
Based on these findings, TSCA section 5(e) Orders requiring the use of 
appropriate exposure controls were negotiated with the PMN submitters. 
As a general matter, EPA believes it is necessary to follow the TSCA 
Orders with a SNUR that identifies the absence of those protective 
measures as significant new uses to ensure that all manufacturers and 
processors--not just the original submitter--are held to the same 
standard.
2. Objectives
    EPA is issuing these SNURs because the Agency wants to
     Receive notice of any person's intent to manufacture or 
process a listed chemical substance for the described significant new 
use before that activity begins.
     Have an opportunity to review and evaluate data submitted 
in a SNUN before the notice submitter begins manufacturing or 
processing a listed chemical substance for the described significant 
new use; and
     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 
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.

C. Applicability of General Provisions

    General provisions for SNURs appear in 40 CFR part 721, subpart A. 
These provisions describe persons required to submit a Significant New 
Use Notice (SNUN), recordkeeping requirements, and exemptions to 
reporting requirements, among other things.
    Provisions relating to user fees appear at 40 CFR part 700. 
Pursuant to 40 CFR 721.1(c), persons submitting a SNUN are subject to 
the same requirements and regulatory procedures as submitters of PMNs 
under TSCA section 5(a)(1)(A). These include the information submission 
requirements of TSCA sections 5(b) and 5(d)(1), the exemptions 
authorized by TSCA sections 5(h)(1), (h)(2), (h)(3), and (h)(5), and 
the regulations at 40 CFR part 720, except where modified in part 721.
    Once EPA receives a SNUN, and before the manufacture or processing 
for the significant new use can commence, EPA must either determine 
that the use addressed in the SNUN 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. If EPA determines that the use 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.

D. Applicability of the Significant New Use Designation

    Any use that EPA determines in the final rule was ongoing as of the 
date of publication of the proposal and did not cease prior to issuance 
of the final rule, will not be designated as a significant new use in 
the final rule. EPA has no information to suggest that any of the 
significant new uses identified in this rule are ongoing.
    Under the procedures in 40 CFR 721.11 a manufacturer or processor 
may request EPA to determine whether a specific use would be a 
significant new use under the rule. The manufacturer or processor must 
show that it has a bona fide intent to manufacture or process the 
chemical substance and must identify the specific use for which it 
intends to manufacture or process the chemical substance. If EPA 
concludes that the person has shown a bona fide intent to manufacture 
or process the chemical substance, EPA will identify any confidential 
significant new use designations under the rule. Since most of the 
chemical identities of the chemical substances subject to these SNURs 
are also CBI, manufacturers and processors can combine the bona fide 
submission under the procedure in 40 CFR 721.11 into a single step to 
identify if a chemical substance is subject to 40 CFR part 721 and if a 
specific use would be a significant new use under the rule.
    The chemical substances subject to this rule have undergone 
premanufacture review. In cases where EPA has not received a notice of 
commencement (NOC) and the chemical substance is not on the TSCA 
Inventory, no person may commence any activities without first 
submitting a PMN. Therefore, when EPA has received a PMN for a chemical 
substance but has not received a NOC for that same substance, the fact 
that a NOC has not been received is evidence that no manufacturing or 
processing of the chemical substance is occuring in the United States. 
When chemical substances identified in this rule 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. However, TSCA Orders have been issued for these chemical 
substances, and the PMN submitters are prohibited by the TSCA Orders 
from undertaking activities which would be designated as significant 
new uses. The identities of many of the chemical substances subject to 
these SNURs have been claimed as confidential per 40 CFR 720.85.
    As discussed in the Federal Register of April 24, 1990 (55 FR 17376 
(FRL-3658-5)), EPA has decided that the intent of TSCA section 
5(a)(1)(B) is best served by designating a use as a significant new use 
as of the date of publication of the proposed rule rather than as of 
the effective date of the final rule. The objective of EPA's approach 
is to ensure that a person cannot impede finalization of a SNUR by 
initiating a significant new use after publication of the proposed rule 
but before the effective date of the final rule. Uses arising after the 
publication of the proposed rule are distinguished from uses that are 
identified in the final rule as having been ongoing on the date of 
publication of the proposed rule. The former would be new uses, the 
latter ongoing uses, except that uses that are identified as ongoing as 
of the publication of the proposed rule would not be considered ongoing 
uses if they have ceased by the date of issuance of a final rule.
    In the unlikely event that before a final rule becomes effective a 
person begins commercial manufacturing (including importing) or 
processing of the chemical substances for a use that is designated as a 
significant new use in that final rule, such a person would have to 
cease any such activity upon the effective date of the final rule. To 
resume their activities, these persons would have to first comply with 
all applicable SNUR notification requirements and wait until all TSCA 
prerequisites for the commencement of

[[Page 87349]]

manufacture or processing have been satisfied.
    Issuance of a SNUR for a chemical substance does not signify that 
the chemical substance is listed on the TSCA Chemical Substance 
Inventory (TSCA Inventory). Guidance on how to determine if a chemical 
substance is on the TSCA Inventory is available on the internet at 
https://www.epa.gov/tsca-inventory.

E. Important Information About SNUN Submissions

1. SNUN Submissions
    According to 40 CFR 721.1(c), persons submitting a SNUN must comply 
with the same notification requirements and EPA regulatory procedures 
as persons submitting a PMN, including submission of test data on 
health and environmental effects as described in 40 CFR 720.50. 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. 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 With the SNUN
    EPA recognizes that TSCA section 5 does not require developing any 
particular new information (e.g., generating test data) before 
submission of a SNUN. There is an exception: If a person is otherwise 
required to submit information for a chemical substance subject to the 
SNUR pursuant to a rule, TSCA 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, 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 or reasonably ascertainable (see 40 CFR 
720.50). However, upon review of PMNs and SNUNs, the Agency may 
determine under TSCA section 5(e) that it is necessary to require 
appropriate testing. Unit IV. of the proposed rule lists potentially 
useful information for the SNURs listed in this document. Descriptions 
of this information is provided for informational purposes. The 
potentially useful information identified in Unit IV. of the proposed 
rule will be useful to EPA's evaluation in the event that someone 
submits a SNUN for the significant new use.
    EPA strongly encourages persons to consult with the Agency before 
performing any testing. Furthermore, pursuant to TSCA section 4(h), 
which pertains to reduction of testing in vertebrate animals, EPA 
encourages dialog 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 listed in Unit IV. of the 
proposed rule may not be the only means of addressing the potential 
risks of the chemical substance. However, submitting a SNUN without any 
test data or other information may increase the likelihood that EPA 
will take action under TSCA sections 5(e) or 5(f). EPA recommends that 
potential SNUN submitters contact EPA early enough so that they will be 
able to conduct the appropriate tests.
    SNUN submitters should be aware that EPA will be better able to 
evaluate SNUNs which provide detailed information on the following:
     Human exposure and environmental release that may result 
from the significant new use of the chemical substances.
     Information on risks posed by the chemical substances 
compared to risks posed by potential substitutes.

III. Public Comments on Proposed Rule and EPA Responses

    EPA received public comments on the proposed rules from seven 
identifying entities. The Agency's responses are presented in the 
Response to Public Comments document that is available in the docket 
for this rulemaking. EPA is not finalizing the SNUR applicable to PMN 
P-20-0105, which was proposed as 40 CFR 721.11764. As described in the 
response to comments EPA will re-propose and finalize that SNUR in a 
future action.

IV. Substances Subject to This Rule

    EPA is establishing significant new use and recordkeeping 
requirements for certain chemical substances in 40 CFR part 721, 
subpart E. In Unit V. of the proposed SNURs, EPA provided the following 
information for each chemical substance:
     PMN number.
     Chemical name (generic name, if the specific name is 
claimed as confidential business information (CBI)).
     Chemical Abstracts Service Registry Number (CAS RN) (if 
assigned for non-confidential chemical identities).
     Effective date of and basis for the TSCA Order.
     Potentially Useful Information. This is information 
identified by EPA that would help characterize the potential health 
and/or environmental effects of the chemical substances if a 
manufacturer or processor is considering submitting a SNUN for a 
significant new use designated by the SNUR.
     CFR citation assigned in the regulatory text section of 
these rules. The regulatory text specifies the activities designated as 
significant new uses. Certain new uses, including production volume 
limits and other uses designated in the rules, may be claimed as CBI. 
In cases where the rules 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.

V. 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 establishes SNURs for new chemical substances that were 
the subject of PMNs. The Office of Management and Budget (OMB) has 
exempted these types of actions from review under Executive Order 12866 
(58 FR 51735, October 4, 1993), 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

[[Page 87350]]

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 associated with SNURs have 
already been approved by OMB pursuant to the PRA under OMB control 
number 2070-0038 (EPA ICR No. 1188.13). 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 response. 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 is amending the table in 40 CFR part 9 to list the SNURs and 
OMB approval number for the information collection activities contained 
in this action. This listing of the OMB control numbers and their 
subsequent codification in the CFR satisfies the display requirements 
of PRA and OMB's implementing regulations at 5 CFR part 1320. The 
Information Collection Request (ICR) covering the SNUR activities was 
previously subject to public notice and comment prior to OMB approval, 
and given the technical nature of the table, EPA finds that further 
notice and comment to amend it is unnecessary. As a result, EPA finds 
that there is ``good cause'' under section 553(b)(3)(B) of the 
Administrative Procedure Act (5 U.S.C. 553(b)(3)(B)) to amend this 
table without further notice and comment.
    EPA always welcomes your feedback on the burden estimate. Send any 
comments about the accuracy of the burden estimate, and any suggested 
methods for minimizing respondent burden, including through the use of 
automated collection techniques, to the Director, Regulatory Support 
Division, Office of Mission Support (2822T), Environmental Protection 
Agency, 1200 Pennsylvania Ave., NW, Washington, DC 20460-0001. Please 
remember to include the OMB control number in any correspondence, but 
do not submit any completed forms to this address.

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 SNUNs per 
year. For example, the number of SNUNs received was 10 in Federal 
fiscal year (FY) FY2016, 14 in FY2017, 16 in FY2018, five in FY2019, 
seven in FY2020, and 13 in FY2021, and only a fraction of these were 
from small businesses.
    In addition, the Agency currently offers relief to qualifying small 
businesses by reducing the SNUN submission fee from $19,020 to $3,330. 
This lower fee reduces the total reporting and recordkeeping cost of 
submitting a SNUN to about $11,164 per SNUN submission for qualifying 
small firms. Therefore, the potential economic impacts of complying 
with this SNUR are not expected to be significant or adversely impact a 
substantial number of small entities. In a SNUR that published in the 
Federal Register of June 2, 1997 (62 FR 29684) (FRL-5597-1), the Agency 
presented its general determination that SNURs are not expected to have 
a significant economic impact on a substantial number of small 
entities, which was provided to the Chief Counsel for Advocacy of the 
Small Business Administration.

D. Unfunded Mandates Reform Act (UMRA)

    Based on EPA's experience with proposing and finalizing SNURs, 
State, local, and Tribal governments have not been impacted by these 
rulemakings, and EPA does not have any reasons to believe that any 
State, local, or Tribal government will be impacted by this action. As 
such, EPA has determined that this action does not impose any 
enforceable duty, contain any unfunded mandate, or otherwise have any 
effect on small governments subject to the requirements of UMRA 
sections 202, 203, 204, or 205 (2 U.S.C. 1501 et seq.).

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 
Tribe Governments

    This action does not have Tribal implications as specified in 
Executive Order 13175 (65 FR 67249, November 9, 2000), because it is 
not expected to have substantial direct effects on Indian Tribes, 
significantly or uniquely affect the communities of Indian Tribal 
governments, and does not involve or impose any requirements that 
affect Indian Tribes. Accordingly, the requirements of Executive Order 
13175 do not apply to this action.

G. Executive Order 13045: Protection of Children From Environmental 
Health Risks and Safety Risks

    This action is not subject to Executive Order 13045 (62 FR 19885, 
April 23, 1997), because it does not concern an environmental health or 
safety risk. Since this action does not concern human health, EPA's 
2021 Policy on Children's Health also does not apply. Although the 
establishment of these SNURs do not address an existing children's 
environmental health concern because the chemical uses involved are not 
ongoing uses, SNURs require that persons notify EPA at least 90 days 
before commencing manufacture (defined by statute to include import) or 
processing of any of these chemical substances for an activity that is 
designated as a significant new use by this rule. 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.

[[Page 87351]]

I. National Technology Transfer and Advancement Act (NTTAA)

    This action does not involve any technical standards subject to 
NTTAA section 12(d) (15 U.S.C. 272 note).

J. Executive Order 12898: Federal Actions To Address Environmental 
Justice in Minority Populations and Low-Income Populations and 
Executive Order 14096: Revitalizing Our Nation's Commitment to 
Environmental Justice for All

    This action does not concern human health or environmental 
conditions and therefore cannot be evaluated with respect to the 
potential for disproportionate impacts on non-white and low-income 
populations in accordance with Executive Order 12898 (59 FR 7629, 
February 16, 1994) and Executive Order 14096 (88 FR 25251, April 26, 
2023). Although this action does not concern human health or 
environmental conditions, the premanufacture notifications required by 
these SNURs allows EPA to assess the intended uses to identify 
potential disproportionate risks and take appropriate actions before 
the activities commence.

K. Congressional Review Act (CRA)

    This action is subject to the CRA (5 U.S.C. 801 et seq.), and EPA 
will submit a rule report to each House of the Congress and to the 
Comptroller General of the United States. This action is not a ``major 
rule'' as defined by 5 U.S.C. 804(2).

List of Subjects

40 CFR Part 9

    Environmental protection, Reporting and recordkeeping requirements.

40 CFR Part 721

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

    Dated: December 12, 2023.
Mary Elissa Reaves,
Director, Office of Pollution Prevention and Toxics.

    Therefore, for the reasons stated in the preamble, 40 CFR chapter I 
is amended as follows:

PART 9--OMB APPROVALS UNDER THE PAPERWORK REDUCTION ACT

0
1. The authority citation for part 9 continues to read as follows:

    Authority:  7 U.S.C. 135 et seq., 136-136y; 15 U.S.C. 2001, 
2003, 2005, 2006, 2601-2671; 21 U.S.C. 331j, 346a; 31 U.S.C. 9701; 
33 U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 1321, 1326, 1330, 
1342, 1344, 1345 (d) and (e), 1361; E.O. 11735, 38 FR 21243, 3 CFR, 
1971-1975 Comp. p. 973; 42 U.S.C. 241, 242b, 243, 246, 300f, 300g, 
300g-1, 300g-2, 300g-3, 300g-4, 300g-5, 300g-6, 300j-1, 300j-2, 
300j-3, 300j-4, 300j-9, 1857 et seq., 6901-6992k, 7401-7671q, 7542, 
9601-9657, 11023, 11048.

0
2. Amend the table in Sec.  9.1 by adding entries for Sec. Sec.  
721.11752 through 721.11763 and 721.11765 through 721.11776 in 
numerical order under the undesignated center heading ``Significant New 
Uses of Chemical Substances'' to read as follows:


Sec.  9.1 OMB   approvals under the Paperwork Reduction Act.

* * * * *

------------------------------------------------------------------------
                                                             OMB control
                      40 CFR citation                            No.
------------------------------------------------------------------------
 
                                * * * * *
------------------------------------------------------------------------
               Significant New Uses of Chemical Substances
------------------------------------------------------------------------
 
                                * * * * *
721.11752..................................................    2070-0038
721.11753..................................................    2070-0038
721.11754..................................................    2070-0038
721.11755..................................................    2070-0038
721.11756..................................................    2070-0038
721.11757..................................................    2070-0038
721.11758..................................................    2070-0038
721.11759..................................................    2070-0038
721.11760..................................................    2070-0038
721.11761..................................................    2070-0038
721.11762..................................................    2070-0038
721.11763..................................................    2070-0038
721.11765..................................................    2070-0038
721.11766..................................................    2070-0038
721.11767..................................................    2070-0038
721.11768..................................................    2070-0038
721.11769..................................................    2070-0038
721.11770..................................................    2070-0038
721.11771..................................................    2070-0038
721.11772..................................................    2070-0038
721.11773..................................................    2070-0038
721.11774..................................................    2070-0038
721.11775..................................................    2070-0038
721.11776..................................................    2070-0038
 
                                * * * * *
------------------------------------------------------------------------

* * * * *

PART 721--SIGNIFICANT NEW USES OF CHEMICAL SUBSTANCES

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

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

Subpart E--Significant New Uses for Specific Chemical Substances

0
4. Add Sec. Sec.  721.11752 through 721.11763 and 721.11765 through 
721.11776 in numerical order to subpart E to read as follows:
Sec
* * * * *
721.11752 Quaternary ammonium salt of polyisobutene succinic acid 
(generic).
721.11753 2-Propenoic acid, 2-alkyl-, 2-(dialkylamino)alkyl ester, 
polymer with .alpha.-(2-alkyl-1-oxo-2-alken-1-yl)-.omega.-
methoxypoly(oxy-1,2-alkanediyl) (generic).
721.11754 Alkanedioic acid, polymer with cycloalkyl dimethanol, 
alkyl and cycloalkyl diisocyanates, dimethyl-alkanediol, 
dihydroxyalkanoic acid methylenebis[isocyanatocyclohexane], 
hydroxyethyl acrylate- and polyalkyl glycol monoalkyl ether blocked 
(generic).
721.11755 Poly(oxy-1,4-butanediyl), .alpha.-hydro-.omega.-hydroxy-, 
polymer with 1,1'-methylenebis[4-isocyanatobenzene], caprolactam-
blocked.
721.11756 Tall-oil pitch, fraction, sterol-low (generic).
721.11757 Carboxylic acid, reaction products with metal hydroxide, 
inorganic dioxide and metal (generic).
721.11758 Multi-walled carbon nanotubes; closed; 4.4-12.8 nm 
diameter; bundle length 10.6-211.1 [micro]m; Grade: Jenotube 6.
721.11759 Multi-walled carbon nanotubes; closed; 5.1-11.6 nm 
diameter; bundle length 1.9-552.0 [micro]m; Grade: Jenotube 8.
721.11760 Multi-walled carbon nanotubes; closed; 7.9-14.2 nm 
diameter; bundle length 9.4-106.4 [micro]m; Grade: Jenotube 10.
721.11761 Multi-walled carbon nanotubes; closed; 17.0-34.7 nm 
diameter; globular shape; Grade: Jenotube 20.
721.11762 Nonanamide, N,N-dimethyl-.
721.11763 2-Propenoic acid, 2-methyl, 2-(dimethylamino)ethyl ester, 
polymers with 2-(C16-18-acylamino)ethyl acrylate and hydroxyalkyl 
acrylate, acetates (generic).
721.11765 2H-Pyran, tetrahydro-4-methyl.
721.11766 Organic acid ester, polymer with aliphatic diols and 1,1'-
methylenebis[4-isocyanatobenzene] (generic).
721.11767 4,4-Methylenebis (2,6-dimethyl phenol) polymer with 2-
(chloromethyl)oxirane, 1,4-benzenediol, 2-methyl-2-propenoic acid, 
mixed alkyl substituted 2-methyl 2-propenoate, and ethyl 2-
propenoate, reaction products with 2-(dimethylamino) ethanol 
(generic).
721.11768 Phenol, methylethylidene, polymer chloromethyl epoxide and 
methylethylidene bis-oxy, bis-amine (generic).
721.11769 Amine, methylethylidenebis(oxy) (generic).
721.11770 Carbamic acid, N-[3-(trialkoxysilyl)propyl]-, C,C'-
[2,2,4(or 2,4,4)-trimethyl-1,6-hexanediyl] ester (generic).
721.11771 Arylfurandione, [bis(trihaloalkyl)alkylidene]bis-, polymer 
with alkanediamine (generic).
721.11772 Phosphonic acid, dimethyl ester, reaction products with 
alkyl-alkyl-alkanediol and alkanediol (generic).
721.11773 Silane, halogenated (generic).
721.11774 Heteromonocycle, polymer, substituted aliphatic carbamate, 
[2-[(1-oxo-2-propen-1-yl)oxy]alkyl]ester (generic).

[[Page 87352]]

721.11775 Alkanes, C4-8-branched and linear.
721.11776 5H-1,2-Oxathiole, 2,2-dioxide.
* * * * *


Sec.  721.11752   Quaternary ammonium salt of polyisobutene succinic 
acid (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
quaternary ammonium salt of polyisobutene succinic acid (PMN P-16-349) 
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)(3), (6)(vii) and (7), (b) and (c). 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)(ix), (2)(i) and (v), and (5). For 
purposes of Sec.  721.72(e), the concentration is set at 1.0%. 
Alternative hazard and warning statements that meet the criteria of the 
Globally Harmonized System and OSHA Hazard Communication Standard may 
be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k). It is a significant new use to 
manufacture, process, or use the substance in any manner that results 
in inhalation exposure. It is a significant new use to use the 
substance in any consumer product to be added to gasoline or diesel 
fuels by the consumer.
    (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 and processors 
of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11753   2-Propenoic acid, 2-alkyl-, 2-(dialkylamino)alkyl 
ester, polymer with .alpha.-(2-alkyl-1-oxo-2-alken-1-yl)-.omega.-
methoxypoly(oxy-1,2-alkanediyl) (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 2-
propenoic acid, 2-alkyl-, 2-(dialkylamino)alkyl ester, polymer with 
.alpha.-(2-alkyl-1-oxo-2-alken-1-yl)-.omega.-methoxypoly(oxy-1,2-
alkanediyl) (PMN P-18-27) 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 (cured) or when 
present as an impurity at less than 1% by weight.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(3) and (5) through (8), and (c). 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 or of at least 1,000 during spray applications.
    (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: specific target organ toxicity; 
skin irritation; eye irritation; skin sensitization. Alternative hazard 
and warning statements that meet the criteria of the Globally 
Harmonized System and OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. It is a 
significant new use to use the substance in formulations at greater 
than 0.1% for spray applications.
    (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.  721.11754   Alkanedioic acid, polymer with cycloalkyl dimethanol, 
alkyl and cycloalkyl diisocyanates, dimethyl-alkanediol, 
dihydroxyalkanoic acid methylenebis[isocyanatocyclohexane], 
hydroxyethyl acrylate- and polyalkyl glycol monoalkyl ether blocked 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
alkanedioic acid, polymer with cycloalkyl dimethanol, alkyl and 
cycloalkyl diisocyanates, dimethyl-alkanediol, dihydroxyalkanoic acid 
methylenebis[isocyanatocyclohexane], hydroxyethyl acrylate- and 
polyalkyl glycol monoalkyl ether blocked (PMN P-18-301) 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)(3) and (7), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (f), and (g)(1) and (5). For purposes of Sec.  
721.72(g)(1), this substance may cause: skin irritation; skin 
sensitization; eye irritation; respiratory sensitization. Alternative 
hazard and warning statements that meet the criteria of the Globally 
Harmonized System and OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(o).
    (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.  721.11755   Poly(oxy-1,4-butanediyl), .alpha.-hydro-.omega.-
hydroxy-, polymer with 1,1'-methylenebis[4-isocyanatobenzene], 
caprolactam-blocked.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as poly(oxy-1,4-
butanediyl), .alpha.-hydro-.omega.-hydroxy-, polymer with 1,1'-
methylenebis[4-isocyanatobenzene], caprolactam-blocked (P-18-340; CAS 
RN 2247074-17-3) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section. The 
requirements of this section do not apply to quantities of the 
substance after they have been completely reacted (cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(3) and (7), and (c).
    (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: respiratory sensitization; skin 
sensitization; reproductive toxicity; specific target organ toxicity. 
Alternative hazard and warning statements that meet the criteria of the 
Globally Harmonized System and OSHA Hazard Communication Standard may 
be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(o). It is a significant new use to use the 
substance other than for one component thermoset elastomer manufacture. 
It is a significant

[[Page 87353]]

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 the substance without the use of a packed tower scrubber 
that removes at least 95 percent of the substance prior to release.
    (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.  721.11756   Tall-oil pitch, fraction, sterol-low (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as tall-
oil pitch, fraction, sterol-low (PMN P-19-165) 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 
(cured).
    (2) The significant new uses are:
    (i) 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 (c), 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.  721.11757   Carboxylic acid, reaction products with metal 
hydroxide, inorganic dioxide and metal (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
carboxylic acid, reaction products with metal hydroxide, inorganic 
dioxide and metal (PMN P-20-10) 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 
(cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(3), (5), (6)(vii), (7) and (8), and (c). 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, or an APF of 50 if dust controls are implemented 
that demonstrate an exposure reduction of at least 30%.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (f), and (g)(1), (3)(iii) and (5). For purposes 
of Sec.  721.72(g)(1), this substance may cause: skin sensitization; 
genetic toxicity; reproductive toxicity; 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) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4), where N=11.
    (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.  721.11758   Multi-walled carbon nanotubes; closed; 4.4-12.8 nm 
diameter; bundle length 10.6-211.1 [micro]m; Grade: Jenotube 6.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as multi-walled carbon 
nanotubes; closed; 4.4-12.8 nm diameter; bundle length 10.6-211.1 
[micro]m; Grade: Jenotube 6 (PMN P-20-62) 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 or incorporated into an article.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(3), (5), (6)(vii), (7) and (8), and (c). 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)(iii) and (5). For purposes 
of Sec.  721.72(g)(1), this substance may cause: skin sensitization; 
eye irritation; respiratory sensitization; carcinogenicity; 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). It is a significant new use to 
manufacture the substance with a maximum weight percent of cobalt oxide 
impurity in excess of 2.1%. It is a significant new use to process or 
use the substance other than as an electrically conductive material, a 
heat dissipation material, a heat generation material, an additive for 
weight reduction, an additive to improve physical or mechanical 
properties, an additive in batteries, energy storage, and electrode 
applications, or an additive in field emission applications. It is a 
significant new use to process or use the substance in application 
methods that do not generate a vapor, mist, dust, or aerosol unless 
such an application method occurs in an enclosed process.
    (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.  721.11759   Multi-walled carbon nanotubes; closed; 5.1-11.6 nm 
diameter; bundle length 1.9-552.0 [micro]m; Grade: Jenotube 8.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as multi-walled carbon 
nanotubes; closed; 5.1-11.6 nm diameter; bundle length 1.9-552.0 
[micro]m; Grade: Jenotube 8 (PMN P-20-63) 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 or incorporated into an article.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in

[[Page 87354]]

Sec.  721.63(a)(3), (5), (6)(vii), (7) and (8), and (c). 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)(iii) and (5). For purposes 
of Sec.  721.72(g)(1), this substance may cause: skin sensitization; 
eye irritation; respiratory sensitization; carcinogenicity; 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). It is a significant new use to 
manufacture the substance with a maximum weight percentage of cobalt 
oxide impurity in excess of 2.1%. It is a significant new use to 
process or use the substance other than as an electrically conductive 
material, a heat dissipation material, a heat generation material, an 
additive for weight reduction, an additive to improve physical or 
mechanical properties, an additive in batteries, energy storage, and 
electrode applications, or an additive in field emission applications. 
It is a significant new use to process or use the substance in 
application methods that do not generate a vapor, mist, dust, or 
aerosol unless such an application method occurs in an enclosed 
process.
    (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.  721.11760   Multi-walled carbon nanotubes; closed; 7.9-14.2 nm 
diameter; bundle length 9.4-106.4 [micro]m; Grade: Jenotube 10.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as multi-walled carbon 
nanotubes; closed; 7.9-14.2 nm diameter; bundle length 9.4-106.4 
[micro]m; Grade: Jenotube 10 (PMN P-20-64) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section. The requirements of this section do not apply 
to quantities of the substance after they have been completely reacted 
or cured or incorporated into an article.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(3), (5), (6)(vii), (7) and (8), and (c). 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)(iii) and (5). For purposes 
of Sec.  721.72(g)(1), this substance may cause: skin sensitization; 
eye irritation; respiratory sensitization; carcinogenicity; 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). It is a significant new use to 
manufacture the substance with a maximum weight percentage of cobalt 
oxide impurity in excess of 2.1%. It is a significant new use to 
process or use the substance other than as an electrically conductive 
material, a heat dissipation material, a heat generation material, an 
additive for weight reduction, an additive to improve physical or 
mechanical properties, an additive in batteries, energy storage, and 
electrode applications, or an additive in field emission applications. 
It is a significant new use to process or use the substance in 
application methods that do not generate a vapor, mist, dust, or 
aerosol unless such an application method occurs in an enclosed 
process.
    (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.  721.11761   Multi-walled carbon nanotubes; closed; 17.0-34.7 nm 
diameter; globular shape; Grade: Jenotube 20.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as multi-walled carbon 
nanotubes; closed; 17.0-34.7 nm diameter; globular shape; Grade: 
Jenotube 20 (PMN P-20-65) 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 or 
incorporated into an article.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(3), (5), (6)(vii), (7) and (8), and (c). 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)(iii) and (5). For purposes 
of Sec.  721.72(g)(1), this substance may cause: skin sensitization; 
eye irritation; respiratory sensitization; carcinogenicity; 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). It is a significant new use to 
manufacture the substance with a maximum weight percentage of cobalt 
oxide impurity in excess of 2.1%. It is a significant new use to 
process or use the substance other than as an electrically conductive 
material, a heat dissipation material, a heat generation material, an 
additive for weight reduction, an additive to improve physical or 
mechanical properties, an additive in batteries, energy storage, and 
electrode applications, or an additive in field emission applications. 
It is a significant new use to process or use the substance in 
application methods that do not generate a vapor, mist, dust, or 
aerosol unless such an application method occurs in an enclosed 
process.
    (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.

[[Page 87355]]

Sec.  721.11762   Nonanamide, N,N-dimethyl-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as nonanamide, N,N-
dimethyl- (PMN P-20-70; CAS RN 6225-08-7) is subject to reporting under 
this section for the significant new uses described in paragraph (a)(2) 
of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(3), (5), (6)(v) and (vi), (7) and (8), (b), and (c). For 
purposes of Sec.  721.63(b), the concentration is set at 1.0%. 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 (f), and (g)(1), (3)(iii) 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; reproductive toxicity; 
aspiration hazard. Alternative hazard and warning statements that meet 
the criteria of the Globally Harmonized System and OSHA Hazard 
Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. It is a 
significant new use to use the substance other than as a solvent for 
use in formulated pesticide products. It is a significant new use to 
manufacture the substance other than by import into the United States 
(i.e., no domestic manufacture) using 20,000 kg International 
Organization for Standardization tank containers (ISOtainers) or 1,000 
kg intermediate bulk containers (IBCs).
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4), where N=96.
    (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.  721.11763   2-Propenoic acid, 2-methyl, 2-(dimethylamino)ethyl 
ester, polymers with 2-(C16-18-acylamino)ethyl acrylate and 
hydroxyalkyl acrylate, acetates (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 2-
propenoic acid, 2-methyl, 2-(dimethylamino)ethyl ester, polymers with 
2-(C16-18-acylamino)ethyl acrylate and hydroxyalkyl acrylate, acetates 
(PMN P-20-84) 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 (cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(3) and (7), (b), and (c). 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; specific target organ toxicity. Alternative hazard and 
warning statements that meet the criteria of the Globally Harmonized 
System and OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(o). It is a significant new use to process 
or use the substance in any manner that results in inhalation exposure.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i) are applicable to manufacturers, importers, and 
processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11765   2H-Pyran, tetrahydro-4-methyl.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 2H-pyran, 
tetrahydro-4-methyl (PMN P-20-127; CAS RN 4717-96-8) 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)(3), (5), (6)(v) and (vi), (7) and (8), (b), and (c). For 
purposes of Sec.  721.63(a)(5), respirators must provide a National 
Institute for Occupational Safety and Health (NIOSH) assigned 
protection factor (APF) of at least 50. For purposes of Sec.  
721.63(b), the concentration is set at 1.0%.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (f), and (g)(1), (3)(iii) 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 corrosion; serious 
eye damage; specific target organ toxicity; aspiration hazard. 
Alternative hazard and warning statements that meet the criteria of the 
Globally Harmonized System and OSHA Hazard Communication Standard may 
be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(o).
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4), where N=540.
    (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.  721.11766   Organic acid ester, polymer with aliphatic diols and 
1,1'-methylenebis[4-isocyanatobenzene] (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as organic 
acid ester, polymer with aliphatic diols and 1,1'-methylenebis[4-
isocyanatobenzene] (PMN P-20-130) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section. The requirements of this section do not apply to 
quantities of the substance after they have been completely reacted 
(cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(3), (5), (6)(ix), (7) amd (8), and (c). For purposes of Sec.  
721.63(a)(5), respirators must provide a National Institute for 
Occupational Safety and Health (NIOSH) assigned protection factor (APF) 
of at least 50.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (f), and (g)(1) and (5). For purposes of Sec.  
721.72(g)(1), this substance may cause: acute toxicity; skin 
irritation; respiratory sensitization; skin sensitization; genetic 
toxicity;

[[Page 87356]]

carcinogenicity; reproductive toxicity; 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 use the 
substance in any manner or method that involves spray application.
    (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.  721.11767   4,4-Methylenebis (2,6-dimethyl phenol) polymer with 
2-(chloromethyl)oxirane, 1,4-benzenediol, 2-methyl-2-propenoic acid, 
mixed alkyl substituted 2-methyl 2-propenoate, and ethyl 2-propenoate, 
reaction products with 2-(dimethylamino) ethanol (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 4,4-
methylenebis (2,6-dimethyl phenol) polymer with 2-
(chloromethyl)oxirane, 1,4-benzenediol, 2-methyl-2-propenoic acid, 
mixed alkyl substituted 2-methyl 2-propenoate, and ethyl 2-propenoate, 
reaction products with 2-(dimethylamino) ethanol (PMN P-21-3) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section. The requirements of this 
section do not apply to quantities of the substance after they have 
been completely reacted (cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(3), (5), (6)(vii), (7) and (8), (b), and (c). 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(g)(1), this substance may cause: skin irritation; eye 
irritation. For purposes of Sec.  721.72(e), the concentration is set 
at 1.0%. Alternative hazard and warning statements that meet the 
criteria of the Globally Harmonized System and OSHA Hazard 
Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(o).
    (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.  721.11768   Phenol, methylethylidene, polymer chloromethyl 
epoxide and methylethylidene bis-oxy, bis-amine (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as phenol, 
methylethylidene, polymer chloromethyl epoxide and methylethylidene 
bis-oxy, bis-amine (PMN P-21-28) 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)(3), (5), (6)(vii), (7) and (8), and (c). 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 in non-spray applications and 1,000 in spray 
applications.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (f) and (g)(1), (3)(iii) and (5). For purposes 
of Sec.  721.72(g)(1), this substance may cause: acute toxicity; skin 
corrosion; skin irritation; serious eye damage; eye irritation; 
respiratory sensitization; skin sensitization; 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) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4), where N=100.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (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.  721.11769   Amine, methylethylidenebis(oxy) (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as amine, 
methylethylidenebis(oxy) (generic) (PMN P-21-29) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section. The requirements of this section do 
not apply to quantities of the substance after they have been 
completely reacted (cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(3), (5), (6)(vii), (7) and (8), and (c). 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 in non-spray applications and 1,000 in spray 
applications.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (f), and (g)(1), (3)(iii) and (5). For purposes 
of Sec.  721.72(g)(1), this substance may cause: acute toxicity; skin 
corrosion; skin irritation; serious eye damage; eye irritation; 
respiratory sensitization; skin sensitization; 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) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4), where N=840.
    (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.

[[Page 87357]]

Sec.  721.11770   Carbamic acid, N-[3-(trialkoxysilyl)propyl]-, C,C'-
[2,2,4(or 2,4,4)-trimethyl-1,6-hexanediyl] ester (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
carbamic acid, N-[3-(trialkoxysilyl)propyl]-, C,C'-[2,2,4(or 2,4,4)-
trimethyl-1,6-hexanediyl] ester (PMN P-21-34) 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 completely reacted 
(cured).
    (2) The significant new uses are:
    (i) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (f), and (g)(1), (3)(iii) 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) 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 (c), (f), 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.  721.11771   Arylfurandione, [bis(trihaloalkyl)alkylidene]bis-, 
polymer with alkanediamine (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
arylfurandione, [bis(trihaloalkyl)alkylidene]bis-, polymer with 
alkanediamine (PMN P-21-67) 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, cured, or formed 
into an article.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(3) and (7), (b), and (c). For purposes of Sec.  721.63(b), 
the concentration is set at 1.0%.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (f), (g)(1), and (5). For purposes of Sec.  
721.72(e), the concentration is set at 1.0%. For purposes of Sec.  
721.72(g)(1), this substance may cause: skin irritation; eye 
irritation; specific target organ toxicity. Alternative hazard and 
warning statements that meet the criteria of the Globally Harmonized 
System and OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. It is a 
significant new use to manufacture or process the substance unless at a 
particle size of 10 microns or greater.
    (iv) Disposal. It is a significant new use to dispose of the 
substance or waste streams containing the substance by incineration 
unless such incineration occurs at a minimum temperature of 870 degrees 
Celsius.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (j) are applicable to manufacturers, importers, and 
processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11772   Phosphonic acid, dimethyl ester, reaction products 
with alkyl-alkyl-alkanediol and alkanediol (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
phosphonic acid, dimethyl ester, reaction products with alkyl-alkyl-
alkanediol and alkanediol (PMN P-21-93) is subject to reporting under 
this section for the significant new uses described in paragraph (a)(2) 
of this section. The requirements of this section do not apply to 
quantities of the substance after they have been completely reacted 
(cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(3) and (7), (b), and (c). 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)(iii) 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 corrosion; serious 
eye damage; eye irritation; reproductive toxicity; specific target 
organ toxicity. Alternative hazard and warning statements that meet the 
criteria of the Globally Harmonized System and OSHA Hazard 
Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. It is a 
significant new use to manufacture, process, or use the substance in 
any manner that generates a dust, mist, particulate, or aerosol that 
results in inhalation exposure. It is a significant new use to use the 
substance in consumer products where the concentration of the substance 
equals or exceeds 3%.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4), where N=180.
    (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.  721.11773   Silane, halogenated (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as silane, 
halogenated (PMN P-21-94) is subject to reporting under this section 
for the significant new uses described in paragraph (a)(2) of this 
section. The requirements of this section do not apply to quantities of 
the substance after they have been completely reacted (cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(3), (5), (6)(vii), (7) and (8), (b), and (c). For purposes of 
Sec.  721.63(b), the concentration is set at 1.0%. 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.
    (A) As an alternative to the respirator requirements in paragraph 
(a)(2)(i) of this section, a manufacture or processor may choose to 
follow the new chemical exposure limit (NCEL) provision listed in the 
TSCA Order for this substance. The NCEL is 0.05 mg/m\3\ 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 whose Sec.  721.30 requests to use the 
NCELs approach are approved by EPA will be required to follow NCELs 
provisions comparable to those

[[Page 87358]]

contained in the corresponding TSCA Order.
    (B) [Reserved]
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (f), and (g)(1), (3)(iii) 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 corrosion; eye 
damage; specific target organ toxicity; pulmonary effects; 
developmental neurotoxicity. Alternative hazard and warning statements 
that meet the criteria of the Globally Harmonized System and OSHA 
Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. It is a 
significant new use to use the substance other than as a deposition 
precursor for the manufacture of electronic components.
    (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.  721.11774   Heteromonocycle, polymer, substituted aliphatic 
carbamate, [2-[(1-oxo-2-propen-1-yl)oxy]alkyl]ester (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
heteromonocycle, polymer, substituted aliphatic carbamate, [2-[(1-oxo-
2-propen-1-yl)oxy]alkyl]ester (PMN P-21-115) 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)(3), (5), (6)(vii), (7) and (8), and (c). 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 or of at least 1,000 during spray applications.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (f), and (g)(1) and (5). For purposes of Sec.  
721.72(g)(1), this substance may cause: skin irritation; eye 
irritation; skin sensitization; respiratory sensitization. Alternative 
hazard and warning statements that meet the criteria of the Globally 
Harmonized System and OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(o).
    (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.  721.11775   Alkanes, C4-8-branched and linear.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as alkanes, C4-8-
branched and linear (PMN P-21-141; CAS RN 2529890-37-5) 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)(3) and (7), (b), and (c). For purposes of Sec.  721.63(b), 
the concentration is set at 0.1%.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a).
    (iii) Industrial, commercial, and consumer activities. It is a 
significant new use to manufacture, process, or use the substance other 
than for use as a transportation fuel, refinery feedstock, or fuel 
blending additive.
    (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.  721.11776   5H-1,2-Oxathiole, 2,2-dioxide.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 5H-1,2-Oxathiole, 
2,2-dioxide (PMN P-21-196; CAS RN 21806-61-1) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section. The requirements of this section do not apply 
to quantities of the substance after they have been incorporated into 
an article.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(3), (5), (6)(v) and (vi), (7) and (8), (b), and (c). 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 0.1%.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (f), and (g)(1), (3)(iii) and (5). For purposes 
of Sec.  721.72(g)(1), this substance may cause: carcinogenicity, 
reproductive toxicity, skin sensitization; respiratory sensitization; 
genetic toxicity; 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). It is a significant new use to process 
or use the substance other than an enclosed system unless the worker 
personal protective equipment described in paragraph (a)(2)(i) is used.
    (iv) Disposal. Requirements as specified in Sec.  721.85(b)(1) and 
(2), and (c)(1) and (2). It is a significant new use to dispose of the 
substance by incineration unless the removal efficiency is at least 
99.9%.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (j) are applicable to manufacturers, importers, and 
processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

[FR Doc. 2023-27653 Filed 12-15-23; 8:45 am]
BILLING CODE 6560-50-P


