Notice2025-15726
Certain New Chemicals; Receipt and Status Information for June 2025
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
August 19, 2025
Issuing agencies
Environmental Protection Agency
Abstract
This document announces the Agency's receipt of new chemical submissions under the Toxic Substances Control Act (TSCA), including information about the receipt of a Premanufacture Notice (PMN), Significant New Use Notice (SNUN), Microbial Commercial Activity Notice (MCAN), and an amendment to a previously submitted notice; test information; a biotechnology exemption application; an application for a test marketing exemption (TME); and a notice of commencement of manufacture (defined by statute to include import) (NOC) for a new chemical substance. This document also provides a periodic status report on the new chemical substances that are currently under EPA review or have recently concluded review. EPA is hereby providing notice of receipt of this information, as required by TSCA, and an opportunity to comment. This document covers the period from 6/1/2025 to 6/30/2025.
Full Text
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<title>Federal Register, Volume 90 Issue 158 (Tuesday, August 19, 2025)</title>
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[Federal Register Volume 90, Number 158 (Tuesday, August 19, 2025)]
[Notices]
[Pages 40360-40364]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-15726]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2025-0067; FRL-12475-06-OCSPP]
Certain New Chemicals; Receipt and Status Information for June
2025
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice of receipt and request for comment.
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SUMMARY: This document announces the Agency's receipt of new chemical
submissions under the Toxic Substances Control Act (TSCA), including
information about the receipt of a Premanufacture Notice (PMN),
Significant New Use Notice (SNUN), Microbial Commercial Activity Notice
(MCAN), and an amendment to a
[[Page 40361]]
previously submitted notice; test information; a biotechnology
exemption application; an application for a test marketing exemption
(TME); and a notice of commencement of manufacture (defined by statute
to include import) (NOC) for a new chemical substance. This document
also provides a periodic status report on the new chemical substances
that are currently under EPA review or have recently concluded review.
EPA is hereby providing notice of receipt of this information, as
required by TSCA, and an opportunity to comment. This document covers
the period from 6/1/2025 to 6/30/2025.
DATES: Comments must be received on or before September 18, 2025.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2025-0067 and the specific case number provided
in this document for the chemical substance related to your comment,
online at <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Follow the online instructions
for submitting comments. Do not submit electronically any information
you consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Additional
instructions on commenting and visiting the docket, along with more
information about dockets generally, is available at <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
FOR FURTHER INFORMATION CONTACT:
For technical information: Jim Rahai, Project Management and
Operations Division (7407M), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; telephone number: (202) 564-8593; email address:
<a href="/cdn-cgi/l/email-protection#ea988b828b83c4808387aa8f9a8bc48d859c"><span class="__cf_email__" data-cfemail="c5b7a4ada4acebafaca885a0b5a4eba2aab3">[email protected]</span></a>.
For general information: The TSCA-Hotline, ABVI-Goodwill, 422 South
Clinton Ave., Rochester, NY 14620; telephone number: (202) 554-1404;
email address: <a href="/cdn-cgi/l/email-protection#085c5b4b492540677c6461666d486d7869266f677e"><span class="__cf_email__" data-cfemail="2b7f78686a0663445f4742454e6b4e5b4a054c445d">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Executive Summary
A. Does this action apply to me?
This action provides information that is directed to the public in
general.
B. What is the Agency's authority for taking this action?
EPA is publishing this document in the Federal Register as required
by sections 5 of the Toxic Substances Control Act (TSCA), 15 U.S.C.
2601 et seq., and corresponding EPA regulations.
Under TSCA, a chemical substance may be either an ``existing''
chemical substance or a ``new'' chemical substance, see <a href="https://www.epa.gov/chemicals-under-tsca">https://www.epa.gov/chemicals-under-tsca</a>. Any chemical substance that is not on
EPA's TSCA Inventory of Chemical Substances (TSCA Inventory) is
classified as a ``new chemical substance,'' while a chemical substance
that is listed on the TSCA Inventory is classified as an ``existing
chemical substance.'' See TSCA section 3(2) and (11). For more
information about the TSCA Inventory, see <a href="https://www.epa.gov/tsca-inventory">https://www.epa.gov/tsca-inventory</a>.
Any person who intends to manufacture (including import) a new
chemical substance for a non-exempt commercial purpose, or to
manufacture or process a chemical substance in a non-exempt manner for
a use that EPA has determined is a significant new use, is required by
TSCA section 5 to provide EPA with a PMN, MCAN, or SNUN, as
appropriate, before initiating the activity. EPA will review the
notice, make a risk determination on the new chemical substance or
significant new use, and take appropriate action as described in TSCA
section 5(a)(3).
TSCA section 5(h)(1) authorizes EPA to allow persons, upon
application and under appropriate restrictions, to manufacture a new
chemical substance, or manufacture or process a chemical substance
subject to a significant new use rule (SNUR) issued under TSCA section
5(a)(2), for ``test marketing'' purposes, upon a showing that the
manufacture, processing, distribution in commerce, use, and disposal of
the chemical substances will not present an unreasonable risk of injury
to health or the environment. This is referred to as a test marketing
exemption, or TME.
Premanufacture notification procedures for review of certain new
microbial products of biotechnology are established in 40 CFR part 725.
These pertain to MCANs and biotechnology exemptions, including TSCA
experimental release applications (TERAs), TMEs for microorganisms, and
Tier I and Tier II exemptions.
C. What action is the Agency taking?
This document provides notice of receipt and status reports for the
covered period and certain submissions under TSCA section 5 and
provides an opportunity to comment on this information. The Agency is
providing information about the receipt of PMNs, SNUNs, MCANs, and
amendments to a previously submitted notice; test information;
biotechnology exemption applications under 40 CFR part 725; TME
applications; NOCs for new chemical substances; and a periodic status
report on chemical substances that are currently under EPA review or
have recently concluded review.
D. What should I consider as I prepare my comments for EPA?
1. Submitting CBI. Do not submit CBI to EPA through <a href="https://www.regulations.gov">https://www.regulations.gov</a> or email. If you wish to include CBI in your
comment, please follow the instructions at <a href="https://www.epa.gov/dockets/commenting-epa-dockets#rules">https://www.epa.gov/dockets/commenting-epa-dockets#rules</a> and clearly mark the information that you
claim to be CBI. In addition to one complete version of the comment
that includes CBI, a copy of the comment without CBI must be submitted
for inclusion in the public docket. Information marked as CBI will not
be disclosed except in accordance with procedures set forth in 40 CFR
parts 2 and 703.
2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at <a href="https://www.epa.gov/dockets/commenting-epa-dockets">https://www.epa.gov/dockets/commenting-epa-dockets</a>.
II. Background
A. What information is being provided in this document?
The tables in this document provide the following information on
the TSCA section 5 submissions received by EPA during this period and
determined to be complete consistent with 40 CFR 720.70(a).
<bullet> Case number. The EPA number assigned to the TSCA section 5
submissions. Please note that a case number may be listed more than
once in the table when the submission involves a subsequent amendment.
<bullet> Chemical substance. Name of the chemical substance, or
generic name if the specific name is claimed as CBI.
<bullet> Manufacturer. Name of the submitting manufacturer, to the
extent that such information is not subject to a CBI claim. The term
``manufacturer'' is defined by statute to include importer.
<bullet> Use(s). Potential uses identified by the manufacturer.
<bullet> Received. Date the submission was received by EPA.
<bullet> Commencement. Date of commencement provided by the
submitter in the NOC.
<bullet> Test information. For test information received, the type
of test information submitted to EPA based on the attachment type and
subtype data selected by the submitter.
B. What do the acronyms mean that are used in the tables?
As used in each of the tables, the following explanations apply:
[[Page 40362]]
<bullet> (S) indicates that the information in the table is the
specific information provided by the submitter.
<bullet> (G) indicates that the information in the table is generic
information because the specific information provided by the submitter
was claimed as CBI.
C. How can I access other information about TSCA section 5 submissions?
EPA provides information on its website about cases reviewed under
TSCA section 5, including the PMNs, SNUNs, MCANs, and exemption
applications received; the date of receipt; the final EPA determination
on the submission; and the effective date of EPA's determination. See
<a href="https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/status-pre-manufacture-notices">https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/status-pre-manufacture-notices</a>. In addition,
information EPA receives about chemical substances under TSCA,
including non-CBI new chemical submissions, can be accessed in ChemView
at <a href="https://chemview.epa.gov/chemview">https://chemview.epa.gov/chemview</a>.
III. Receipt Reports
Table 1 provides non-CBI information for the PMNs, SNUNs and MCANs
received by EPA that have passed an initial screening and determined to
be complete consistent with 40 CFR 720.70(a) during this period.
Table 1--PMN/SNUN/MCANs Received and Under Review
----------------------------------------------------------------------------------------------------------------
Case No. Received date Manufacturer Use Chemical substance
----------------------------------------------------------------------------------------------------------------
P-21-0059........ 06/24/2025 CBI............. (G) Stabilizer.. (S) Methanesulfonic acid,1,1,1-trifluoro-
, ytterbium (3+) salt (3:1).
P-22-0158........ 06/18/2025 Aqdot........... (G) Additive (S) 1H,4H,14H,17H-2,16:3,15-Dimethano-
used in 5H,6H,7H,8H,9H,10H,11H,
consumer, 12H,13H,18H,19H,20H,21H,22H,23H,24H,25H,2
commercial, and 6H-2,3,4a,5a,6a,7a,8a,9a,10a,11a,
industrial 12a,13a,15,16,17a,18a,19a,20a,21a,22a,23a
applications. ,24a,25a,26a-
tetracosaazabispentaleno[1''',6''':
5'',6'',7'']cycloocta[1'',2'',3'':
3',4']pentaleno[1',6':5,6,7]cycloocta[1,2
,3-gh:1',2',3'-g'h']
cycloocta[1,2,3-cd:5,6,7-c'd']dipentalene-
1,4,6,8,10,12,14,17,19,21,23,
25-dodecone, dodecahydro-,
stereoisomer;2,18:3,17-Dimethano-
2,3,4a,5a,
6a,7a,8a,9a,10a,11a,12a,13a,14a,15a,17,18
,19a,20a,21a,22a,23a,24a,25a,
26a,27a,28a,29a,30aoctacosaazabispentalen
o[1''''',
6''''':5'''',6'''',7'''']
cycloocta[1'''',2'''',3'''':3''',
4''']pentaleno[1''',6''':5'',6'',7'']
cycloocta[1'',2'',3'':3',4']pentaleno[1',
6':5,6,7]cycloocta[1,
2,3-cd:1',2',3'-gh]pentalene-
1,4,6,8,10,12,14,16,19,21,23,25,27,29-
tetradecone,
tetradecahydro-, stereoisomer;2,20:3,19-
Dimethano-2,3,4a,5a,6a,7a,8a,
9a,10a,11a,12a,13a,14a,15a,16a,17a,19,20,
21a,22a,23a,24a,25a,26a,27a,28a,29a,
30a,31a,32a,33a,34adotriacontaazabispenta
leno[1''''',6'''''
:5'''',6'''',7'''']cycloocta[1'''',
2'''',3'''':3''',4''']pentaleno[1''',6'''
:5'',6'',7'']cycloocta[1'',2'',3'':3',4']
pentaleno
[1',6':5,6,7]cycloocta[1,2,3-gh:1',2',3'-
g'h']cycloocta[1,2,3-cd:5,6,7-c'd']
dipentalene-
1,4,6,8,10,12,14,16,18,21,23,25,27,29,31
,33-hexadecone,hexadecahydro-,
stereoisomer.
P-23-0081........ 05/30/2025 Ashland, Inc.... (S) Gas., (G) Alkyl glycidyl ether, polymer with
Polymer used as Poly(oxy-1,2-ethanediyl).
a non-ionic
surfactant in
water-based
separator
coatings used
in the
manufacture of
batteries
registered
pesticide
products.
P-24-0083........ 06/02/2025 CBI............. (G) Ingredient (G) Branched alcohol alkoxylate.
for cleaning
products,
Ingredient for
cleaning
products.
P-24-0186........ 06/26/2025 SGP Ventures, (S) Epoxy used (S) 2-Oxiranemethanamine, N-[2-methyl-4-
Inc. to fill holes (2-oxiranylmethoxy) phenyl]-N-(2-
in printed oxiranylmethyl)-.
circuit boards.
P-24-0191........ 06/10/2025 CBI............. (G) Conductive (S) Carbon nanotube, multi-walled in
agent. tubular shape.
P-25-0065........ 06/02/2025 Itaconix Corp... (S) Chemical (S) Butanedioic acid, 2-methylene-, 1,4-
intermediate in dimethyl ester; Butanedioic acid, 2-
polymer methylene-, 1-ethyl 4-methyl ester;
production. Butanedioic acid, 2-methylene-, 4-ethyl
1-methyl ester.
P-25-0098........ 05/29/2025 CBI............. (G) (G) Sulfonium, tricarbocyclic-, alpha,
Photolithograph alpha, beta, beta-polyfluoropolyhydro-2-
y. (haloheterocyclic)-4,7-methano-1,3-
heteropolycyclic-5-alkanesulfonate
(1:1).
P-25-0100........ 05/22/2025 CBI............. (G) Exported for (G) Aromatic sulfonium tricyclo salt with
use outside the alkyl carbomonocycle hetero acid.
US, Photoacid
generator use
at customer
sites.
P-25-0103........ 06/05/2025 CBI............. (G) Component of (G) Alkanedioic acid, polyhalo,
photoresist. carbomonocycle [[(alkyl-substituted
alkenyl) substituted] alkyl] ester,
homopolymer.
P-25-0105........ 05/29/2025 CBI............. (S) Treatment (G) Alkanamide, 2,2'-[(halo[1,1'-
agent for biphenyl]-4,4'-diyl) bis(2,1-
pigments. diazenediyl)] bis [3-oxo-, N,N'-
bis(heterocyclic aryl and di-substituted
aryl).
P-25-0106........ 05/30/2025 CBI............. (G) Component of (G) Sulfonium
photoresist. tris(substitutedcarbomonocycle)
substituted oxatricycloalkyloxycarbonyl
dihalo alkane sulfonate.
P-25-0107........ 05/30/2025 CBI............. (G) Component of (G) Heteromonocyclic alkylsubstituted
photoresist. carbomonocyclic carbopolycyclic
heteromonocyclic dihalo sulfoacetate.
P-25-0109........ 06/11/2025 CBI............. (S) Treatment (G) Alkanamide, 2,2-[(dihalo[1,1-
agent for biphenyl]-4,4-diyl) bis(2,1-
pigments., diazenediyl)] bis [3-oxo-, N,N-bis(halo-
Treatment agent alkoxy aryl and substituted aryl).
for pigments in
inks.
[[Page 40363]]
P-25-0110........ 06/11/2025 CBI............. (G) Ink (G) Quino[2,3-b] acridine-7,14-dione,
component. 5,12-dihydro-, (substituted
heteropolycyclic) alkyl and sulfo
derivs.
P-25-0111........ 06/12/2025 CBI............. (G) Photoacid (G) Haloaromatic iodonium dicyclo salt
generator use with polyfluoroalkyl carbomonocycle
at customer hetero acid.
sites.
P-25-0112........ 06/11/2025 CBI............. (G) Additive for (G) Haloaromatic iodonium dicyclo salt
use in with halogenated hydroxyaryl carboxylic
electronics acid.
industry.
P-25-0113........ 06/11/2025 Momentive (S) A co-monomer (G) Siloxanes and Silicones, di-Me, 2-
Performance in acrylic [hydroxy[(2-alkyl-1-oxo-2-propen-1-yl)
Materials. latex oxy] cyclohexyl] alkyl group-terminated.
production.
P-25-0113........ 06/18/2025 Momentive (S) A co-monomer (G) Siloxanes and Silicones, di-Me, 2-
Performance in acrylic [hydroxy[(2-alkyl-1-oxo-2-propen-1-yl)
Materials. latex oxy] cyclohexyl] alkyl group-terminated.
production.
P-25-0114........ 06/11/2025 Greene Tweed & (G) Polymer (G) Carbamic acid, N,N'-(diimino-
Company. additive. polyfluoroalkyl)bis-C,C'-bisalkyl ester.
P-25-0115........ 06/18/2025 CBI............. (G) Deposition (G) Silylamine.
material for
use in
electronics
industry.
P-25-0116........ 06/19/2025 Heraeus Epurio, (S) Use as a (S) Sulfonium, triphenyl-, salt with
LLC. photoacid tris[(trifluoromethyl)sulfonyl] methane
generator for (1:1).
photoresist
applications.
P-25-0117........ 06/26/2025 CBI............. (G) site-limited (G) Amino acid, N, N-bis(cyanoalkyl)-,
intermediate. sodium salt.
SN-23-0024....... 06/23/2025 CBI............. (G) Component in (S) Phosphoric acid, iron (2+) lithium
batteries. salt (1:1:1).
----------------------------------------------------------------------------------------------------------------
Table 2 provides non-CBI information on the NOCs received by EPA
that have passed an initial screening during this period.
Table 2--NOCs Received and Under Review
------------------------------------------------------------------------
Received Commencement
Case No. date date Chemical substance
------------------------------------------------------------------------
P-12-0106.......... 06/16/2025 06/04/2025 (G) Alkyl
methacrylate
polymer with
aromatic vinyl
monomer,
benzenedicarboxylic
acid anhydride and
alkyl
methacrylates,
dialkylalkanate,
peroxide-initiated.
P-15-0138.......... 06/10/2025 06/05/2025 (S) Titanium,
trichloromethoxy-,
(T-4)-.
P-19-0048.......... 06/30/2025 06/12/2025 (S) Poly(oxy-1,2-
ethanediyl), -hydro-
hydroxy-, mono-C12-
14-alkyl ethers,
phosphates, sodium
salts.
P-21-0088.......... 06/27/2025 06/03/2025 (G) Heterocyclic
epoxide polymer
with mixed
substituted glycols
and acid anhydride.
P-24-0004.......... 06/30/2025 06/15/2025 (S) L-Aspartic acid,
N-benzoyl-, sodium
salt (1:2).
------------------------------------------------------------------------
Table 3 provides non-CBI information on the test information that
has been received by EPA that have passed an initial screening during
this period.
Table 3--Test Information Received
----------------------------------------------------------------------------------------------------------------
Received
Case No. date Type of test information Chemical substance
----------------------------------------------------------------------------------------------------------------
P-14-0712...................... 06/11/2025 Polychlorinated Dibenzodioxins (G) Plastics, wastes, pyrolyzed,
and Polychlorinated bulk pyrolysate.
Dibenzofurans Testing.
P-14-0712...................... 06/12/2025 Dioxin Report................... (G) Plastics, wastes, pyrolyzed,
bulk pyrolysate.
P-21-0202...................... 06/11/2025 Water Solubility (Shake Flask (G) Sulfonium, carbomonocycle
Method) (OECD Test Guideline bis [(Tri haloalkyl)
105); Partition Coefficient (n- carbomonocycle], substituted
Octanol/Water): Shake Flask carbomonocyclic ester.
Method (OECD Test Guideline
107); Dissociation Constants in
Water (Conductometric Method)
(OECD Test Guideline 112).
P-22-0014...................... 06/13/2025 Study Report.................... (G) Sodium
bis(chloropropanediol)
phosphate.
P-22-0014...................... 06/27/2025 Ready Biodegradability (Closed (G) Sodium
Bottle) (OECD Test Guideline bis(chloropropanediol)
301D); Freshwater Alga and phosphate.
Cyanobacteria, Growth
Inhibition Test (OECD Test
Guideline 201).
P-23-0049...................... 06/13/2025 Water Solubility (Column Elution (G) Sulfonium, tricarboxylic-, 2-
Method) (OECD Test Guideline aryl-polyfluoro polyhydro-
105). alkano-heteropolycycle-
alkanesulfonate (1:1), polymer
with heteroatom substituted
aryl and carbomonocyclic 2-
alkyl-2-alkanoate, di-Me 2,2-
(1,2-diazenediyl) bis[2-
methylpropanoate]-initiated.
[[Page 40364]]
P-25-0067...................... 06/11/2025 Water Solubility (Shake Flask (G) Sulfonium, bis (dihalo
Method) (OECD Test Guideline carbomonocycle) carbomonocycle-
105); Partition Coefficient (n- , salt with trihalobenzoate.
Octanol/Water): Shake Flask
Method (OECD Test Guideline
107); Dissociation Constants in
Water (Conductometric Method)
(OECD Test Guideline 112).
P-25-0110...................... 06/12/2025 Estimation of the Adsorption (G) Quino[2,3-b] acridine-7,14-
Coefficient (Koc) on Soil and dione, 5,12-dihydro-,
on Sewage Sludge using High (substituted heteropolycyclic)
Performance Liquid alkyl and sulfo derivs.
Chromatography (HPLC) (OECD
Test Guideline 121); Daphnia
magna Reproduction Test (OECD
Test Guideline 211); in Vitro
Mammalian Cell Gene Mutation
Test Data; Prenatal Toxicity in
Rats Test Data; Repeated Dose
28-day Oral Toxicity Study in
Rodents (OECD Test Guideline
407); Melting Point/Melting
Range (OECD Test Guideline
102); Boiling Point (OECD Test
Guideline 103); Density of
Liquids and Solids (OECD Test
Guideline 109); Vapour Pressure
(OECD Test Guideline 104);
Determination of pH, Acidity
and Alkalinity (OECD Test
Guideline 122); Dissociation
Constants in Water (OECD Test
Guideline 112); Ready
Biodegradability, MITI (I)
(Ministry of International
Trade and Industry, Japan)
(OECD Test Guideline 301C);
Ready Biodegradability, CO2
Evolution (Modified Sturm Test)
(OECD Test Guideline 301B);
Fish Acute Toxicity Test (OECD
Test Guideline 203); Daphnia
sp. Acute Immobilization Test
(OECD Test Guideline 202);
Freshwater Alga and
Cyanobacteria, Growth
Inhibition Test (OECD Test
Guideline 201); Activated
Sludge, Respiration Inhibition
Test (Carbon Ammonium
Oxidation) (OECD Test Guideline
209); Acute Oral Toxicity--
Acute Toxic Class Method (OECD
Test Guideline 423); Acute
Dermal Irritation/Corrosion
(OECD Test Guideline 404);
Acute Eye Irritation/Corrosion
(OECD Test Guideline 405); Skin
Sensitization, Local Lymph Node
Assay: BrdU-ELISA or -FCM (OECD
Test Guideline 442B); Bacterial
Reverse Mutation Test (OECD
Test Guideline 471); in Vitro
Mammalian Chromosomal
Aberration Test (OECD Test
Guideline 473).
----------------------------------------------------------------------------------------------------------------
IV. Status Reports
Information about the TSCA section 5 PMNs, SNUNs, MCANs, and
exemption applications received, including the date of receipt, the
status of EPA's review, the final EPA determination, and the effective
date of EPA's determination, is available online at: <a href="https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/status-pre-manufacture-notices">https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/status-pre-manufacture-notices</a>.
Authority: 15 U.S.C. 2601 et seq.
Dated: August 14, 2025.
Mary Elissa Reaves,
Director, Office of Pollution Prevention and Toxics.
[FR Doc. 2025-15726 Filed 8-18-25; 8:45 am]
BILLING CODE 6560-50-P
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