Notice2024-27717
Certain New Chemicals; Receipt and Status Information for October 2024
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
November 27, 2024
Issuing agencies
Environmental Protection Agency
Abstract
EPA is required under the Toxic Substances Control Act (TSCA), as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act, to make information publicly available and to publish information in the Federal Register pertaining to submissions under TSCA section 5, including notice of receipt of a Premanufacture notice (PMN), Significant New Use Notice (SNUN) or Microbial Commercial Activity Notice (MCAN), including an amended notice or test information; an exemption application (Biotech exemption); an application for a test marketing exemption (TME), both pending and/or concluded; a notice of commencement (NOC) of manufacture (including import) for new chemical substances; and a periodic status report on new chemical substances that are currently under EPA review or have recently concluded review. This document covers the period from October 1, 2024 to October 31, 2024.
Full Text
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<title>Federal Register, Volume 89 Issue 229 (Wednesday, November 27, 2024)</title>
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[Federal Register Volume 89, Number 229 (Wednesday, November 27, 2024)]
[Notices]
[Pages 93576-93580]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-27717]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2024-0057; FRL-11683-10-OCSPP]
Certain New Chemicals; Receipt and Status Information for October
2024
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: EPA is required under the Toxic Substances Control Act (TSCA),
as amended by the Frank R. Lautenberg Chemical Safety for the 21st
Century Act, to make information publicly available and to publish
information in the Federal Register pertaining to submissions under
TSCA section 5, including notice of receipt of a Premanufacture notice
(PMN), Significant New Use Notice (SNUN) or Microbial Commercial
Activity Notice (MCAN), including an amended notice or test
information; an exemption application (Biotech exemption); an
application for a test marketing exemption (TME), both pending and/or
concluded; a notice of commencement (NOC) of manufacture (including
import) for new chemical substances; and a periodic status report on
new chemical substances that are currently under EPA review or have
recently concluded review. This document covers the period from October
1, 2024 to October 31, 2024.
DATES: Comments identified by the specific case number provided in this
document must be received on or before December 27, 2024.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2024-0057, through the Federal eRulemaking
Portal 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)
[[Page 93577]]
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 contact: Jim
Rahai, Project Management and Operations Division (MC 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#2f5d4e474e46014546426f4a5f4e01484059"><span class="__cf_email__" data-cfemail="b1c3d0d9d0d89fdbd8dcf1d4c1d09fd6dec7">[email protected]</span></a>. For general
information contact: 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#d084839391fd98bfa4bcb9beb590b5a0b1feb7bfa6"><span class="__cf_email__" data-cfemail="6a3e39292b4722051e0603040f2a0f1a0b440d051c">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Executive Summary
A. What action is the Agency taking?
This document provides the receipt and status reports for the
period from October 1, 2024 to October 31, 2024. The Agency is
providing notice of receipt of PMNs, SNUNs, and MCANs (including
amended notices and test information); an exemption application under
40 CFR part 725 (Biotech exemption); TMEs, both pending and/or
concluded; NOCs to manufacture a new chemical substance; and a periodic
status report on new chemical substances that are currently under EPA
review or have recently concluded review.
EPA is also providing information on its website about cases
reviewed under the amended TSCA, including the section 5 PMN/SNUN/MCAN
and exemption notices received, the date of receipt, the final EPA
determination on the notice, and the effective date of EPA's
determination for PMN/SNUN/MCAN notices on its website 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>. This information is updated on a
weekly basis.
B. What is the Agency's authority for taking this action?
Under the Toxic Substances Control Act (TSCA), 15 U.S.C. 2601 et
seq., a chemical substance may be either an ``existing'' chemical
substance or a ``new'' chemical substance. 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(11).) For more
information about the TSCA Inventory please go to: <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 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 or
process a new chemical substance, or 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
will not present an unreasonable risk of injury to health or the
environment. This is referred to as a test marketing exemption, or TME.
For more information about the requirements applicable to a new
chemical go to: <a href="https://www.epa.gov/chemicals-under-tsca">https://www.epa.gov/chemicals-under-tsca</a>.
Under TSCA sections 5 and 8 and EPA regulations, EPA is required to
publish in the Federal Register certain information, including notice
of receipt of a PMN/SNUN/MCAN (including amended notices and test
information); an exemption application under 40 CFR part 725 (biotech
exemption); an application for a TME, both pending and concluded; NOCs
to manufacture a new chemical substance; and a periodic status report
on the new chemical substances that are currently under EPA review or
have recently concluded review.
C. Does this action apply to me?
This action provides information that is directed to the public in
general.
D. Does this action have any incremental economic impacts or paperwork
burdens?
No.
E. What should I consider as I prepare my comments for EPA?
1. Submitting confidential business information (CBI). Do not
submit this information to EPA through <a href="http://regulations.gov">regulations.gov</a> or email.
Clearly mark the part or all of the information that you claim to be
CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark
the outside of the disk or CD-ROM as CBI and then identify
electronically within the disk or CD-ROM the specific information that
is claimed as CBI. In addition to one complete version of the comment
that includes information claimed as CBI, a copy of the comment that
does not contain the information claimed as CBI must be submitted for
inclusion in the public docket. Information so marked will not be
disclosed except in accordance with procedures set forth in 40 CFR part
2.
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. Status Reports
In the past, EPA has published individual notices reflecting the
status of TSCA section 5 filings received, pending, or concluded. In
1995, the Agency modified its approach and streamlined the information
published in the Federal Register after providing notice of such
changes to the public and an opportunity to comment (see the Federal
Register of May 12, 1995 (60 FR 25798) (FRL-4942-7)). Since the passage
of the Lautenberg amendments to TSCA in 2016, public interest in
information on the status of section 5 cases under EPA review and, in
particular, the final determination of such cases, has increased. In an
effort to be responsive to the regulated community, the users of this
information, and the general public, to comply with the requirements of
TSCA, to conserve EPA resources and to streamline the process and make
it more timely, EPA is providing information on its website about cases
reviewed under the amended TSCA, including the section 5 PMN/SNUN/MCAN
and exemption notices received, the date of receipt, the final EPA
determination on the notice, and the effective date of EPA's
determination for PMN/SNUN/MCAN notices on its website 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>. This information is updated on a
weekly basis.
III. Receipt Reports
For the PMN/SNUN/MCANs that have passed an initial screening by EPA
during this period, Table I provides the following information (to the
extent that such information is not subject to a CBI claim) on the
notices screened by EPA
[[Page 93578]]
during this period: The EPA case number assigned to the notice that
indicates whether the submission is an initial submission, or an
amendment, a notation of which version was received, the date the
notice was received by EPA, the submitting manufacturer (i.e., domestic
producer or importer), the potential uses identified by the
manufacturer in the notice, and the chemical substance identity.
As used in each of the tables in this unit, (S) indicates that the
information in the table is the specific information provided by the
submitter, and (G) indicates that this information in the table is
generic information because the specific information provided by the
submitter was claimed as CBI. Submissions which are initial submissions
will not have a letter following the case number. Submissions which are
amendments to previous submissions will have a case number followed by
the letter ``A'' (e.g. P-18-1234A). The version column designates
submissions in sequence as ``1'', ``2'', ``3'', etc. Note that in some
cases, an initial submission is not numbered as version 1; this is
because earlier version(s) were rejected as incomplete or invalid
submissions. Note also that future versions of the following tables may
adjust slightly as the Agency works to automate population of the data
in the tables.
Table I--PMN/SNUN/MCANs Approved * from 10/01/2024 to 10/31/2024
----------------------------------------------------------------------------------------------------------------
Received
Case No. Version date Manufacturer Use Chemical substance
----------------------------------------------------------------------------------------------------------------
P-18-0127A.............. 2 10/01/2024 Takasago.......... (S) Fragrance in (S) Heptane, 2-methoxy-
fine fragrance, 2-methyl-.
consumer
products,
household
products (laundry
detergent),
shower gels and
shampoos.
P-21-0007A.............. 2 10/25/2024 CBI............... (G) Catalyst...... (G) Reaction products
of Aluminoxanes, Me,
Me group-terminated
and
(alkylcycloalkenyl)
dialkylzirconium.
P-21-0008A.............. 2 10/25/2024 CBI............... (G) Catalyst...... (G) Reaction products
of Aluminoxanes, Me,
Me group-terminated
and cycloalkylene
dialkyl tetrahydro
indenyl zirconium.
P-22-0068A.............. 4 10/04/2024 Aditya Birla (S) An epoxy (S) 2-Propanamine, 1,1'-
Chemicals (USA), component used in [(1-
LLC. a reaction with methylethylidene)bis(o
other components xy)]bis-.
to produce an
epoxy article.
P-23-0014A.............. 2 10/25/2024 CBI............... (G) Intermediate (G) [Polyalkyl-
in production of methylenepolyhydro-
fragrance. polycyclic] alkyl
acetate.
P-23-0086A.............. 7 10/15/2024 CBI............... (G) Additive for (S) 1,2-
surfactant Benzisothiazole, 3-
performance methyl-,1,1-dioxide.
enhancement;
intermediate used
in the
manufacturing of
detergents.
P-24-0006A.............. 7 10/14/2024 CBI............... (S) Oilfield (G) Propenoic acid,
Production Scale methyl-
Inhibitor. [phosphinicobis(oxy-
ethanediyl)] ester,
telomer with methyl -
methyl-propenoate,
(phosphonooxy) ethyl
methyl-propenoate,
propenoic acid, sodium
methyl-[(oxo-propen-
yl) amino]-
propanesulfonate and
sodium sulfite, sodium
salt, peroxydisulfuric
acid sodium salt -
initiated.
P-24-0160A.............. 3 09/30/2024 CBI............... (G) Photoacid (G) Iodonium, bis
generator use at (dialkyl
customer sites. carbomonocycle) salt
with alkyl
carbomonocycle hetero
acid.
P-24-0186A.............. 4 10/21/2024 SGP Ventures, Inc. (S) Epoxy used to (S) 2-
fill holes in Oxiranemethanamine, N-
printed circuit [2-methyl-4-(2-
boards. oxiranylmethoxy)
phenyl]-N-(2-
oxiranylmethyl)-.
P-24-0193A.............. 2 10/10/2024 CBI............... (G) Dispersive use (G) Perfluorosulfonic
acid polymer, with
perfluoro dioxolane.
P-24-0196............... 1 09/30/2024 Toray Resin Co.... (S) Additives for (S) 2-Pyrrolidinone,
architectural polymer with 2-
paints oxepanone.
(elongation
improvers).
P-24-0196A.............. 2 10/15/2024 Toray Resin Co.... (S) Additives for (S) 2-Pyrrolidinone,
architectural polymer with 2-
paints oxepanone.
(elongation
improvers).
P-25-0001A.............. 2 10/21/2024 Polyfil, Inc...... (G) UV initiated (G) Alkoxy
crosslinker. benzophenone.
P-25-0001A.............. 3 10/28/2024 CBI............... (G) UV crosslinker (G) Alkoxy
initiator. benzophenone.
P-25-0003............... 1 10/24/2024 CBI............... (G) Contained use (G) Phenoxathiin ium,
for 10-phenyl-,
microlithography tricycloalkylcarbomono
for electronic cyclesulfonate (1:1).
device
manufacturing.
P-25-0004............... 1 10/25/2024 CBI............... (G) Contained use (G) Sulfonium,
for triphenyl-,
microlithography heteropolyclyclecarbox
for electronic ylate (1:1).
device
manufacturing.
P-25-0005............... 1 10/28/2024 CBI............... (G) For use in (G) Cashew, nutshell
coatings for liq., polymer with
metal parts. [(aminoalkyl)imino]
bis[alkanol],
bisphenol and
epichlorohydrin,
reaction products with
dialkanolamine, alkyl
carboxylates (salts)
alkanesulfonates
(salts).
P-25-0006............... 1 10/28/2024 CBI............... (G) For use in (G) Phenol, 4,4-(1-
coatings for alkylidene) bis-,
metal parts. polymer with
[(aminoalkyl)imino]
bis[alkanol] and 2-
(chloromethyl)
oxirane, 3-alkyloxy-2-
hydroxypropyl ethers,
reaction products with
dialkanolamine, alkyl
carboxylates (salts).
alkanesulfonates
(salts).
P-25-0007............... 1 10/28/2024 CBI............... (G) For use in (G) Phenol, 4,4-(1-
coatings for alkylidene) bis-,
metal parts. polymer with
[(aminoalkyl)imino]
bis[alkanol] and 2-
(chloromethyl)
oxirane, 4-alkylphenyl
ethers, reaction
products with
dialkanolamine, alkyl
carboxylates (salts)
alkanesulfonates
(salts).
[[Page 93579]]
P-25-0008............... 1 10/28/2024 CBI............... (G) For use in (G) Benzenediol,
coatings for polymer with
metal parts. [(aminoalkyl)imino]
bis[alkanol], 2-
(chloromethyl)oxirane
and 4,4-(1-alkylidene)
bis[phenol], 4-
alkylphenyl ethers,
reaction products with
dialkanolamine, alkyl
carboxylates (salts)
alkanesulfonates
(salts).
P-25-0009............... 1 10/28/2024 CBI............... (G) For use in (G) Cashew, nutshell
coatings for liq., polymer with
metal parts. [(aminoalkyl)imino]
bis[alkanol],
bisphenol,
epichlorohydrin and
benzenediol, reaction
products with
dialkanolamine, alkyl
carboxylates (salts)
alkanesulfonates
(salts).
P-25-0010............... 1 10/28/2024 CBI............... (G) For use in (G) Benzenediol,
coatings for polymer with
metal parts. [(aminoalkyl)imino]
bis[alkanol], 2-
(chloromethyl)oxirane
and 4,4-(1-alkylidene)
bis[phenol], 3-
alkyloxy-2-
hydroxypropyl ethers,
reaction products with
dialkanolamine, alkyl
carboxylates (salts)
alkanesulfonates
(salts).
P-25-0012............... 1 10/30/2024 Bedoukian (G) Site limited (G) Alkanoic acid, 4-
Research, Inc.. chemical bromo-, ethyl ester.
intermediate.
SN-22-0010A............. 4 10/24/2024 CBI............... (S) Monomer (S) 2-Oxazolidinone, 3-
chemical, ethenyl-5-methyl-.
reactive diluent
in UV coating
formulations
(existing use,
approved by PMN P-
18-0392, additive
in UV adhesive
formulations (new
use).
SN-25-0001.............. 1 10/16/2024 Ishihara (S) Black pigment (S) Calcium manganese
Corporation (USA). for architectural titanium oxide.
paint; Pigment
used for non-
spray
applications
(e.g., to make
articles such as
plastics, resins,
fabrics, and
textiles, use in
adhesives).
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In Table II of this unit, EPA provides the following information
(to the extent that such information is not claimed as CBI) on the NOCs
that have passed an initial screening by EPA during this period: The
EPA case number assigned to the NOC including whether the submission
was an initial or amended submission, the date the NOC was received by
EPA, the date of commencement provided by the submitter in the NOC, a
notation of the type of amendment (e.g., amendment to generic name,
specific name, technical contact information, etc.) and chemical
substance identity.
Table II--NOCs Approved * From 10/01/2024 to 10/31/2024
--------------------------------------------------------------------------------------------------------------------------------------------------------
If amendment, type of
Case No. Received date Commencement date amendment Chemical substance
--------------------------------------------------------------------------------------------------------------------------------------------------------
J-24-0016............................... 10/16/2024 09/24/2024 N........................... (G) Chromosomally modified Saccharomyces
cerevisiae.
J-24-0017............................... 10/16/2024 09/24/2024 N........................... (G) Chromosomally modified Saccharomyces
cerevisiae.
J-24-0018............................... 10/16/2024 09/24/2024 N........................... (G) Chromosomally modified Saccharomyces
cerevisiae.
J-24-0019............................... 10/16/2024 09/24/2024 N........................... (G) Chromosomally modified Saccharomyces
cerevisiae.
P-20-0183............................... 10/29/2024 10/05/2024 N........................... (G) Aryl ether epoxide, homopolymer, ether
with alkanolamine.
P-21-0181............................... 10/15/2024 09/17/2024 N........................... (S) 1,3-Benzenedicarboxamide, N1, N3-bis(3-
methylphenyl)-5-[[(3-methylphenyl) amino]
sulfonyl]-.
P-22-0095............................... 10/14/2024 10/13/2024 N........................... (G) Glycolipids.
P-22-0155............................... 10/23/2024 10/14/2024 N........................... (G) 2-alkyl-1,2-heteropolycycle-3-one.
P-23-0094............................... 10/08/2024 09/10/2024 N........................... (G) Polymer of benzenedicarboxylic acid,
substituted-benzenedicarboxylic acid,
branched-alkyldiol, alkyldiol and
triisocyanato.
P-23-0164............................... 10/07/2024 10/06/2024 N........................... (S) Bismuth, 1,1',1'',1'''-(1,2-
ethanediyldinitrilo) tetrakis[2-propanol]
2-(2-ethoxyethoxy) ethanol neodecanoate
polypropylene glycol complexes.
P-23-0167............................... 10/21/2024 09/22/2024 N........................... (G) Bisalkyldiacid fluorophosphate salt.
P-24-0131............................... 10/30/2024 10/28/2024 N........................... (S) Heptanoic acid, 2-octyldodecyl ester.
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In Table III of this unit, EPA provides the following information
(to the extent such information is not subject to a CBI claim) on the
test information that has been received during this time period: The
EPA case number assigned to the test information; the date the test
information was received by EPA, the type of test information
submitted, and chemical substance identity.
Table III--Test Information Received From 10/01/2024 to 10/31/2024
----------------------------------------------------------------------------------------------------------------
Received
Case No. date Type of test information Chemical substance
----------------------------------------------------------------------------------------------------------------
L-24-0191............................ 10/16/2024 Final Report................. (S) 1-Propene, 1-chloro-3,3,3-
trifluoro-, (1Z).
P-08-0200............................ 10/29/2024 Required Annual Reporting per (G) Partially fluorinated
Consent Order. amphiphilic condensation
polymer.
[[Page 93580]]
P-08-0643............................ 10/29/2024 Required Annual Reporting per (G) Fluorinated acrylic
Consent Order. copolymer.
P-08-0748............................ 10/29/2024 Required Annual Reporting per (G) Fluorinated acrylic
Consent Order. copolymer.
P-09-0245............................ 10/29/2024 Required Annual Reporting per (G) Partially fluorinated
Consent Order. alcohol, reaction products
with phosphorous oxide
(P2O5), ammonium salts.
P-10-0058............................ 10/29/2024 Required Annual Reporting per (G) Partially fluorinated
Consent Order. alcohol substituted glycol.
P-11-0091............................ 10/29/2024 Required Annual Reporting per (G) Fluorinated Acrylic
Consent Order. Alkylamino Copolymer.
P-11-0526............................ 10/29/2024 Required Annual Reporting per (G) Amphoteric fluorinated
Consent Order. surfactant.
P-12-0450............................ 10/29/2024 Required Annual Reporting per (G) Partially fluorinated
Consent Order. alcohol, reaction products
with phosphorus oxide
(P2O5), amine salts.
P-14-0712............................ 10/08/2024 Quarterly Testing of (S) Waste plastics,
Substance Using EPA Method pyrolyzed, C5-55 fraction.
8290A.
P-14-0712............................ 10/30/2024 Testing of Substance (S) Waste plastics,
Described Using EPA Method pyrolyzed, C5-55 fraction.
8290A.
P-16-0543............................ 10/01/2024 Exposure Monitoring Data..... (G) Halogenophosphoric acid
metal salt.
P-16-0543............................ 10/22/2024 Exposure Monitoring Data..... (G) Halogenophosphoric acid
metal salt.
P-22-0042............................ 10/02/2024 Bacterial Reverse Mutation (G) Alkanedione,
Test (OECD Test Guideline [[[(substituted)aryl] thio]
471). aryl]-, 2-(O-acetyloxime).
P-22-0042............................ 10/16/2024 The summary of range finding (G) Alkanedione,
study for OECD422 and [[[(substituted)aryl] thio]
protocol. aryl]-, 2-(O-acetyloxime).
P-22-0042............................ 10/18/2024 Notice of test scheduling.... (G) Alkanedione,
[[[(substituted)aryl] thio]
aryl]-, 2-(O-acetyloxime).
----------------------------------------------------------------------------------------------------------------
If you are interested in information that is not included in these
tables, you may contact EPA's technical information contact or general
information contact as described under FOR FURTHER INFORMATION CONTACT
to access additional non-CBI information that may be available.
Authority: 15 U.S.C. 2601 et seq.
Dated: November 21, 2024.
Pamela Myrick,
Director, Project Management and Operations Division, Office of
Pollution Prevention and Toxics.
[FR Doc. 2024-27717 Filed 11-26-24; 8:45 am]
BILLING CODE 6560-50-P
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