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[Federal Register Volume 90, Number 3 (Monday, January 6, 2025)]
[Rules and Regulations]
[Pages 567-573]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-30964]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 9 and 721

[EPA-HQ-OPPT-2019-0530; FRL-7645-02-OCSPP]
RIN 2070-AB27

Significant New Use Rules on Certain Chemical Substances (19-5.F)

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). The SNURs 
require persons to 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 in the SNUR. 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 any risk management actions as are 
required as a result of that determination.

DATES: This rule is effective on March 7, 2025. For purposes of 
judicial review, this rule shall be promulgated at 1 p.m. (EST) on 
January 21, 2025.

ADDRESSES: The docket for this action, identified under docket 
identification (ID) number EPA-HQ-OPPT-2019-0530, 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

[[Page 568]]

information about the docket available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: 
    For technical information: James Yan, New Chemicals Division 
(7405M), Office of Pollution Prevention and Toxics, Environmental 
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; telephone number: (202) 564-2138; email address: 
[email protected].
    For technical information: William Wysong, New Chemicals Division 
(7405M), Office of Pollution Prevention and Toxics, Environmental 
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; telephone number: (202) 564-4163; email address: 
[email protected].
    For general information: The TSCA-Hotline, ABVI-Goodwill, 422 South 
Clinton Ave., Rochester, NY 14620; telephone number: (202) 554-1404; 
email address: [email protected].

SUPPLEMENTARY INFORMATION:

I. Executive Summary

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

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

B. What action is the Agency taking?

    EPA is finalizing SNURs under TSCA section 5(a)(2) for chemical 
substances that were the subject of PMNs P-16-541, P-17-299, P-18-172, 
P-19-99, P-19-118, and P-19-120. The SNURs require persons who intend 
to manufacture or process any of these chemical substances for an 
activity that is designated as a significant new use in the SNURs to 
notify EPA at least 90 days before commencing that activity.
    Previously, in the Federal Register of December 6, 2019 (84 FR 
66855) (FRL-10001-48), EPA proposed SNURs for these chemical substances 
along with nineteen other SNURs. EPA finalized the proposed SNURs for 
P-17-393, P-19-86, P-19-87, P-19-89, P-19-90, P-19-91, P-19-92, P-19-
93, P-19-97, P-19-100, P-19-101, P-19-102, P-19-103, P-19-104, P-19-
105, P-19-106, P-19-107, P-19-108, and P-19-110 in a previous Federal 
Register notice of August 18, 2021 (86 FR 46133) (FRL-8000-02-OCSPP). 
EPA is not currently finalizing the SNURs for the chemical substances 
which were the subject of PMNs P-18-387 and P-18-388 and will address 
these SNURs in a future notice in order to consider new information 
about exposures. More information on the specific chemical substances 
subject to this final rule can be found in the Federal Register 
document proposing the SNURs. The docket includes information 
considered by the Agency in developing the proposed and final rules, 
including the public comments received on the proposed rules that are 
described in Unit II.

C. 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 requirements under TSCA. 
Chemical importers are subject to TSCA section 13 (15 U.S.C. 2612), the 
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. Importers of chemical substances in bulk 
form, as part of a mixture, or as part of an article (if required by 
rule) 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, any persons who export or 
intend to export a chemical substance identified in this document are 
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.

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

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

II. Background

    Unit II. of the proposed rule provides general information about 
SNURs, and additional information about EPA's new chemical program is 
available at https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca.

[[Page 569]]

A. Significant New Uses Claimed as Confidential Business Information 
(CBI)

    EPA is establishing certain significant new uses which have been 
claimed as CBI subject to Agency confidentiality regulations at 40 CFR 
part 2 and 40 CFR part 703. Absent a final determination or other 
disposition of the confidentiality claim under these regulations, EPA 
is required to keep this information confidential. EPA promulgated a 
procedure at 40 CFR 721.11 to deal with the situation where a specific 
significant new use is CBI.
    Under these procedures a manufacturer or processor may request EPA 
to identify the confidential significant new use under the rule. The 
manufacturer or processor must show that it has a bona fide intent to 
manufacture or process the chemical substance. If EPA concludes that 
the person has shown a bona fide intent to manufacture or process the 
chemical substance, EPA will identify the confidential significant new 
use to that person. Since most of the chemical identities of the 
chemical substances subject to these SNURs are also CBI, manufacturers 
and processors can combine the bona fide submission under the procedure 
in 40 CFR 721.11 into a single step.

B. 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 meet those criteria.
    As discussed in the Federal Register of April 24, 1990 (55 FR 17376 
(FRL-3658-5)), EPA believes 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 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.

C. Important Information About SNUN Submissions

1. SNUN Submissions
    SNUNs must be submitted on EPA Form No. 7710-25, generated using e-
PMN software, and submitted to the Agency in accordance with the 
procedures set forth in 40 CFR 720.40 and 721.25. E-PMN software is 
available electronically at https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca.
2. Development and Submission of Information
    EPA recognizes that TSCA section 5 does not require development of 
any particular new information (e.g., generating test data) before 
submission of a SNUN. There is an exception: If a person is required to 
submit information for a chemical substance pursuant to a rule, order 
or consent agreement under TSCA section 4, then TSCA section 5(b)(1)(A) 
requires such information to be submitted to EPA at the time of 
submission of the SNUN.
    In the absence of a rule, TSCA order, or consent agreement under 
TSCA section 4 covering the chemical substance, persons are required 
only to submit information in their possession or control and to 
describe any other information known to or reasonably ascertainable by 
them (see 40 CFR 720.50). However, upon review of PMNs and SNUNs, the 
Agency has the authority to require appropriate testing. To assist with 
EPA's analysis of the SNUN, submitters are encouraged, but not 
required, to provide the potentially useful information identified for 
the chemical substance in Unit IV of the proposed rule.
    EPA strongly encourages persons, before performing any testing, to 
consult with the Agency pertaining to protocol selection. Furthermore, 
pursuant to TSCA section 4(h), which pertains to reduction of testing 
in vertebrate animals, EPA encourages consultation with the Agency on 
the use of alternative test methods and strategies (also called New 
Approach Methodologies, or NAMs), if available, to generate the 
recommended test data. EPA encourages dialog with Agency 
representatives to help determine how best the submitter can meet both 
the data needs and the objective of TSCA section 4(h). For more 
information on alternative test methods and strategies to reduce 
vertebrate animal testing, visit https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/alternative-test-methods-and-strategies-reduce.
    The potentially useful information described in Unit IV of the 
proposed rule may not be the only means of providing information to 
evaluate the chemical substance associated with the significant new 
uses. However, submitting a SNUN without any test data may increase the 
likelihood that EPA will take action under TSCA sections 5(e) or 5(f). 
EPA recommends that potential SNUN submitters contact EPA early enough 
so that they will be able to conduct the appropriate tests.
    SNUN submitters should be aware that EPA will be better able to 
evaluate SNUNs which provide detailed information on the following:
     Human exposure and environmental release that may result 
from the significant new use of the chemical substances.

D. Public Comments on Proposed Rule and EPA Responses

    EPA received public comments from two identifying entities and two 
confidential entities pertaining to the SNURs that the Agency is 
finalizing with this rule. One comment was generally critical of the 
rule but did not identify specific changes or issues with the rule 
requirements; therefore, no response is required. Two of the comments 
identified ongoing uses of two different chemical substances in the 
proposed rule. As a result, EPA is issuing a modified final rule for 
those chemical substances that do not designate the ongoing uses as 
significant new uses. Specifically, for the chemical substance that was 
the subject of P-17-299, EPA will no longer designate as a

[[Page 570]]

significant new use the use of the chemical substance in a manner that 
generates a dust, mist, or aerosol. EPA is instead designating as a 
significant new use the use of the chemical substance by workers unless 
specific respiratory protection is provided. For the chemical substance 
that was the subject of P-18-172, EPA is not designating use of the 
chemical substance in architectural coatings that are consumer products 
as a significant new use. A summary of all of the comments and the 
Agency's responses to these comments are presented in the Response to 
Public Comments document. The comments and the Response to Public 
Comments are available in the docket for this rule.

III. Chemical Substances Subject to These SNURs

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

    EPA designates December 6, 2019, as the cutoff date for determining 
whether the new use is ongoing. This designation is explained in more 
detail in Unit VI of the proposed rule.

B. What information is provided for each chemical substance?

    In Unit IV. of the proposed rule, EPA provided the following 
information for each chemical substance subject to these SNURs:
     PMN number (the CFR citation assigned in the regulatory 
text section of this document).
     Chemical name (generic name, if the specific name is 
claimed as CBI).
     Chemical Abstracts Service Registry Number (CASRN) (if 
assigned for non-confidential chemical identities).
     Potentially useful information.
    The regulatory text section specifies the activities designated as 
significant new uses. Certain new uses, including exceeding production 
volume limits and other uses designated in the proposed rules, may be 
claimed as CBI.
    In addition, as discussed in Unit V.A. of the proposed rule, for 
the chemical substances that have undergone premanufacture review, EPA 
has identified certain conditions of use and other circumstances of use 
apart from those intended by the PMN submitter as significant new uses. 
All uses identified as significant new uses in this rule cannot occur 
without first going through a separate EPA review and determination 
process associated with a SNUN.

IV. Statutory and Executive Order Reviews

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

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

    This action 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 PRA, 44 U.S.C. 3501 et seq., an agency may not conduct 
or sponsor, and a person is not required to respond to a collection of 
information that requires OMB approval under PRA, unless it has been 
approved by OMB and displays a currently valid OMB control number. The 
OMB control numbers for EPA's regulations in title 40 of the CFR, after 
appearing in the Federal Register, are listed in 40 CFR part 9, and 
included on the related collection instrument or form, if applicable.
    The information collection requirements 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 submission. This burden estimate includes the time 
needed to review instructions, search existing data sources, gather and 
maintain the data needed, and complete, review, and submit the required 
SNUN.
    EPA always welcomes your feedback on the burden 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.

C. Regulatory Flexibility Act (RFA)

    I certify that this action will not have a significant economic 
impact on a substantial number of small entities under the RFA (5 
U.S.C. 601 et seq.). The requirement to submit a SNUN applies to any 
person (including small or large entities) who intends to engage in any 
activity described in the final rule as a ``significant new use.'' 
Because these uses are ``new,'' based on all information currently 
available to EPA, EPA has concluded that no small or large entities 
presently engage in such activities.
    A SNUR requires that any person who intends to engage in such 
activity in the future must first notify EPA by submitting a SNUN. 
Although some small entities may decide to pursue a significant new use 
in the future, EPA cannot presently determine how many, if any, there 
may be. However, EPA's experience to date is that, in response to the 
promulgation of SNURs covering over 1,000 chemicals, the Agency 
receives only a small number of notices per year. For example, the 
number of SNUNs received was 16 in Federal fiscal year (FY) FY2018, 
five in FY2019, seven in FY2020, 13 in FY2021, 11 in FY2022, and 15 in 
FY2023, and only a fraction of these submissions were from small 
businesses.
    In addition, the Agency currently offers relief to qualifying small 
businesses by reducing the SNUN submission fee from $37,000 to 6,480. 
This lower fee reduces the total reporting and recordkeeping cost of 
submitting a SNUN to about $14,500 per SNUN submission for qualifying 
small firms. Therefore, the potential economic impacts of complying 
with these SNURs are not expected to be significant or adversely impact 
a substantial number of small entities. In a SNUR that published in the 
Federal Register of June 2, 1997 (62 FR 29684) (FRL-5597-1), the Agency 
presented its general determination that SNURs are not expected to have 
a significant economic impact on a substantial number of small 
entities, which was provided to the Chief Counsel for Advocacy of the 
Small Business Administration.

D. Unfunded Mandates Reform Act (UMRA)

    This action does not contain an unfunded mandate of $100 million or 
more (in 1995 dollars) in any one year as described in UMRA, 2 U.S.C. 
1531-1538, and does not significantly or uniquely affect small 
governments. Based on EPA's experience with proposing and finalizing 
SNURs, State, local, and Tribal governments have not been impacted by 
SNURs, and EPA does not have any reasons to believe that any State, 
local, or Tribal government will be impacted by these SNURs. In 
addition, the estimated costs of this action to the private sector do 
not exceed $183 million or more in any one year (the 1995 dollars are 
adjusted to 2023 dollars for inflation using the GDP implicit price 
deflator). The estimated

[[Page 571]]

costs for this action are discussed in Unit I.D.

E. Executive Order 13132: Federalism

    This action will not have federalism implications as specified in 
Executive Order 13132 (64 FR 43255, August 10, 1999), because it is not 
expected to have a substantial direct effect on States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government. Accordingly, the requirements of Executive Order 13132 do 
not apply to this action.

F. Executive Order 13175: Consultation and Coordination With Indian 
Tribal Governments

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

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

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

I. National Technology Transfer and Advancement Act (NTTAA)

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

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

    This action does not concern human health or environmental 
conditions and therefore cannot be evaluated with respect to the 
potential for disproportionate impacts on non-white and low-income 
populations in accordance with Executive Order 12898 (59 FR 7629, 
February 16, 1994) and Executive Order 14096 (88 FR 25251, April 26, 
2023). Although this action does not concern human health or 
environmental conditions, the premanufacture notifications required by 
these SNURs allow EPA to assess the 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 20, 2024.
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.  
721.11420 and 721.11421, 721.11423, and 721.11444 through 721.11446 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.

* * * * *

------------------------------------------------------------------------
                   40 CFR citation                      OMB control No.
------------------------------------------------------------------------
 
                                * * * * *
------------------------------------------------------------------------
               Significant New Uses of Chemical Substances
------------------------------------------------------------------------
 
                                * * * * *
721.11420...........................................           2070-0012
721.11421...........................................           2070-0012
 
                                * * * * *
721.11423...........................................           2070-0012
 
                                * * * * *
721.11444...........................................           2070-0012
721.11445...........................................           2070-0012
721.11446...........................................           2070-0012
 
                                * * * * *
------------------------------------------------------------------------

* * * * *

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.  721.11420, 721.11421, 721.11423, and 721.11444 
through 721.11446 to Subpart E to read as follows:

Sec.

* * * * *
721.11420 Soybean meal, reaction products with phosphoric 
trichloride.
721.11421 2-propenoic acid, alkyl, polymers with alkyl acrylate and 
polyethylene glycol methacrylate alkyl ether (generic).

* * * * *

[[Page 572]]

721.11423 Calcium, carbonate 2-ethylhexanoate neodecanoate 
propionate complexes.

* * * * *
721.11444 Propanoic acid, 3-hydroxy-2-(hydroxymethyl)-2-methyl-, 
polymer with dimethyl carbonate, 1,2-ethanediamine, 2-ethyl-2-
(hydroxymethyl)-1,3-propanediol, 1,6-hexanediol and 1,1'-
methylenebis[4-isocyanatocyclohexane], compd. with N,N-
diethylethanamine.
721.11445 Substituted polyalkylenepoly, reaction products with 
alkene polymer (generic).
721.11446 Alkenoic acid, polymer with alkanediyl bis substituted 
alkylene bis heteromonocycle, substituted carbomonocycle and 
(alkylalkenyl) carbomonocycle, alkali metal salt (generic).
* * * * *

Sec.  721.11420   Soybean meal, reaction products with phosphoric 
trichloride.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as soybean meal, 
reaction products with phosphoric trichloride (PMN P-16-541, CASRN 
1962913-92-3) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4), where N=22.
    (ii) [Reserved]
    (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 and 
processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11421   2-propenoic acid, alkyl, polymers with alkyl acrylate 
and polyethylene glycol methacrylate alkyl ether (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 2-
propenoic acid, alkyl, polymers with alkyl acrylate and polyethylene 
glycol methacrylate alkyl ether (PMN P-17-299) 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)(4) through (6), and (c). When determining which persons are 
reasonably likely to be exposed as required for Sec.  721.63(4), 
engineering control measures (e.g., enclosure or confinement of the 
operation, general and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures) shall be considered 
and implemented to prevent exposure, where feasible. For purposes of 
Sec.  721.63(a)(5), respirators must provide a National Institute for 
Occupational Safety and Health (NIOSH) assigned protection factor (APF) 
of at least 1,000.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f). It is a significant new use to use the 
substance other than as a thickener in paint. It is a significant new 
use to use the substance in concentrations greater than 1% in 
formulated products.
    (b) Specific requirements. The provisions of Subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c), and (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.  721.11423   Calcium, carbonate 2-ethylhexanoate neodecanoate 
propionate complexes.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as calcium, carbonate 
2-ethylhexanoate neodecanoate propionate complexes (PMN P-18-172) 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) Industrial, commercial, and consumer activities. It is a 
significant new use to use the substance in a consumer product except 
for use in architectural coatings. It is a significant new use to use 
the substance other than as an auxiliary drier for architectural 
paints, industrial coatings and stains.
    (ii) [Reserved]
    (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 (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.  721.11444   Propanoic acid, 3-hydroxy-2-(hydroxymethyl)-2-methyl-
, polymer with dimethyl carbonate, 1,2-ethanediamine, 2-ethyl-2-
(hydroxymethyl)-1,3-propanediol, 1,6-hexanediol and 1,1'-
methylenebis[4-isocyanatocyclohexane], compd. with N,N-
diethylethanamine.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as propanoic acid, 3-
hydroxy-2-(hydroxymethyl)-2-methyl-, polymer with dimethyl carbonate, 
1,2-ethanediamine, 2-ethyl-2-(hydroxymethyl)-1,3-propanediol, 1,6-
hexanediol and 1,1'-methylenebis[4-isocyanatocyclohexane], compd. with 
N,N-diethylethanamine (PMN P-19-99, CASRN 1178511-46-0) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section. (2) The significant new uses are:
    (i) 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 as a clear coat for wood.
    (ii) [Reserved]
    (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 (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.  721.11445   Substituted polyalkylenepoly, reaction products with 
alkene polymer (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
substituted polyalkylenepoly, reaction products with alkene polymer 
(PMN P-19-118) 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) Industrial, commercial, and consumer activities. It is a 
significant new use to manufacture, process, or use the substance in 
any manner that results in inhalation exposure.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part

[[Page 573]]

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 (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.  721.11446   Alkenoic acid, polymer with alkanediyl bis 
substituted alkylene bis heteromonocycle, substituted carbomonocycle 
and (alkylalkenyl) carbomonocycle, alkali metal salt (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
alkenoic acid, polymer with alkanediyl bis substituted alkylene bis 
heteromonocycle, substituted carbomonocycle and (alkylalkenyl) 
carbomonocycle, alkali metal salt (PMN P-19-120) 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) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) where N=78.
    (ii) [Reserved]
    (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 and 
processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

[FR Doc. 2024-30964 Filed 1-3-25; 8:45 am]
BILLING CODE 6560-50-P
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