[Federal Register Volume 90, Number 35 (Monday, February 24, 2025)]
[Notices]
[Pages 10485-10489]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-02994]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2024-0057; FRL-11683-12-OCSPP]
Certain New Chemicals; Receipt and Status Information for
December 2024
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice and request for comment.
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SUMMARY: EPA is required under the Toxic Substances Control Act (TSCA)
to make information publicly available and to publish information in
the Federal Register pertaining to submissions under TSCA, 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 12/01/2024 to 12/31/2024.
DATES: Comments must be received on or before March 26, 2025.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2024-0057 and the specific case number provided
in this document for the chemical substance related to your comment,
online at https://www.regulations.gov. Follow the online instructions
for submitting comments. Do not submit electronically any information
you
[[Page 10486]]
consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Additional
instructions on commenting and visiting the docket, along with more
information about dockets generally, is available at https://www.epa.gov/.
FOR FURTHER INFORMATION CONTACT:
For technical information: 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: [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 action is the Agency taking?
This document provides the receipt and status reports for the
period from 12/01/2024 to 12/31/2024. 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: https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/status-pre-manufacture-notices.
B. What is the Agency's authority for taking this action?
Under 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: https://www.epa.gov/inventory.
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: https://www.epa.gov/under-tsca.
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 CBI. Do not submit CBI to EPA through https://www.regulations.gov or email. If you wish to include CBI in your
comment, please follow the instructions at https://www.epa.gov/dockets/commenting-epa-dockets#rules 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 https://www.epa.gov/dockets/commenting-epa-dockets.
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
particularly 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: https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/status-pre-manufacture-notices.
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 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
[[Page 10487]]
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 1--PMN/SNUN/MCANs Approved *
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Received
Case No. Version date Manufacturer Use Chemical substance
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J-25-0002............. 1 11/27/2024 Greenlight (G) To produce DNA (G) Strain of
Biosciences, Inc. for use in Escherichia coli
internal modified with
manufacturing. genetically stable,
plasmid-borne DNA for
the production of
plasmid-borne DNA.
J-25-0003............. 1 12/05/2024 Greenlight (G) To produce an (G) Strain of
Biosciences, Inc. enzyme for use in Escherichia coli
internal modified with
manufacturing. genetically stable,
plasmid-borne DNA for
the production of an
enzyme.
P-20-0184A............ 6 12/05/2024 P2 Science, Inc.... (S) For use in (S) 6-Octen-1-ol, 3,7-
fragrances for dimethyl-, homopolymer.
consumer products,
Specific functions
would be as
solubilizer,
rheology modifier
and fragrance oil.
P-22-0126A............ 4 12/16/2024 Takasago........... (S) This polymer (S) Cellulose, polymer
constitutes the with 1,1'-[2-ethyl-2-
wall of [(3-mercapto-1-
microcapsules oxopropoxy) methyl]-1,3-
containing propanediyl] bis(3-
fragrance that can mercaptopropanoate) and
be used in 1,2,3-propanetriol
different homecare bis(2-methyl-2-
and personal-care propenoate),
applications. peroxydisulfuric acid
([(HO)S(O)2]2O2)
ammonium salt (1:2)-
and sodium (disulfite)
(2:1)-initiated.
P-23-0035A............ 3 11/27/2024 CBI................ (G) Isolated (G) Aryl alkoxy ether.
intermediate.
P-23-0141A............ 3 12/12/2024 Hach Company....... (G) Buffer solution (S) 2-Butenedioic acid
for free chlorine (2Z)-, potassium salt
determination. (1:?).
P-24-0046A............ 3 12/05/2024 The Euclid Chemical (S) Grinding aid (G) Alkanol, alkoxyalkyl
Company. used in cement imino, salt.
manufacture.
P-24-0047A............ 3 12/05/2024 The Euclid Chemical (S) Grinding aid (G) Alkanol, nitrilo,
Company. used in cement salt
manufacture.
P-24-0123............. 3 11/29/2024 CBI................ (S) Resin raw (G) Plant oil,
material. microorganism-
fermented,
hydroxylalkenoic acid-
hydroxylalkenoic acid
polymer, Oils,
microorganism-
fermented,
hydroxylalkenoic acid-
hydroxylalkenoic acid
polymer.
P-25-0024............. 1 12/02/2024 Momentive (S) Intermediate... (S) Silane,
Performance chlorodimethyl(2,4,4-
Materials. trimethylpentyl)-.
P-25-0025............. 1 12/02/2024 CBI................ (G) (G) Carbomonocyclic
Photolithography. alcohol, 4,4- [[6-
(heteroatom-substituted
carbomonocycle)-
heteromonocycle-2,4-
diyl] heteroatom-
substituted] bis-.
P-25-0026............. 1 12/03/2024 Anderson (G) Additive in (G) Bi-heteromonocycle,
Development lithium-ion polyoxide.
Company. batteries.
P-25-0027............. 2 12/19/2024 Elemental Advanced (S) The CNOs (S) Graphene, Carbon
Materials, Inc. produced do not Nano-Onions.
require any
further treatment
for its
application on
concrete, resins,
batteries, paints,
asphalt,
polyurethanes,
etc. Additionally,
the CNOs are ready
to be combined
with other
nanostructures to
create 2nd
generation Li-Ion
batteries and
antimicrobial
materials or
composites.
P-25-0028............. 1 12/05/2024 CBI................ (G) Contained use (G) Heteroonium, tri
for (substituted aromatic
microlithography hydrocarbon)-, nitrate
for electronic (1:1).
device
manufacturing.
P-25-0029............. 2 12/11/2024 CBI................ (G) Functional (S) Graphene Oxide.
additive in
composite,
precursor for high-
value
nanomaterials.
P-25-0030............. 2 12/11/2024 CBI................ (G) precursor for (S) Graphene Oxide.
high-value
nanomaterials,
Functional
additive in
composite.
P-25-0031............. 1 12/06/2024 Bedoukian Research, (G) site limited (G) Bromoalkyl acetate.
Inc. chemical
intermediate.
P-25-0031A............ 2 12/11/2024 Bedoukian Research, (G) site limited (G) Bromoalkyl acetate.
Inc. chemical
intermediate.
P-25-0032............. 1 12/08/2024 Duksan Electera (S) Chemical (S) Carbonic acid,
America, Inc. substance will be methyl 2-propyn-1-yl
used as an ester.
additive in the
manufacture of
battery
electrolytes.
P-25-0033............. 2 12/13/2024 HPC Holdings, Inc.. (S) Use as a (S) Ethane, 1,1'-
cosolvent for the [methylenebis(osy)] bis
electrolyte in [2,2,2-trifluoro-.
sealed lithium-ion
battery cells;
Process solvent in
industrial closed
loop systems;
Industrial Carrier/
Cleaning solvent
(for vapor
cleaning, vapor
degreasing, and
vapor deposition).
[[Page 10488]]
P-25-0034............. 1 12/10/2024 Piedmont Chemical (S) Additive for UV (S) Benzenemethanamine,
Industries I, LLC. curing of road N, N-dimethyl-, N-oxide
markings, Additive Benzyldimethyllamine-N-
for UV curing of oxide.
adhesives of
coatings, Additive
for UV curing of
adhesives or
coatings.
P-25-0036............. 1 12/16/2024 Bedoukian Research, (S) site limited (G) 6-Alken-2-yne, 1-(1-
Inc. chemical ethoxyethoxy)-, (6Z)-.
intermediate.
P-25-0037............. 1 12/19/2024 Momentive (S) Intermediate... (S) Silane,
Performance dimethyl(2,4,4-
Materials. trimethylpentyl)-.
P-25-0040............. 1 12/20/2024 Motiva Enterprises, (G) Intermediate... (G) Gases, processed.
LLC.
P-25-0041............. 1 12/23/2024 Motiva Enterprises, (G) Additive for (G) Hydrocarbon,
LLC. consumer, processed.
commercial, and
industrial uses.
P-25-0042............. 1 12/23/2024 Motiva Enterprises, (G) Additive for (G) Hydrocarbon,
LLC. consumer, processed.
commercial, and
industrial uses.
P-25-0043............. 1 12/23/2024 Motiva Enterprises, (G) Additive for (G) Hydrocarbon,
LLC. consumer, processed.
commercial, and
industrial uses.
P-25-0044............. 1 12/23/2024 Motiva Enterprises, (G) Additive for (G) Hydrocarbon,
LLC. consumer, processed.
commercial, and
industrial uses.
P-25-0045............. 1 12/23/2024 Motiva Enterprises, (G) Additive for (G) Hydrocarbons, carbon
LLC. consumer, range.
commercial, and
industrial uses.
P-25-0046............. 1 12/23/2024 Motiva Enterprises, (G) Additive for (G) Hydrocarbon,
LLC. consumer, processed.
commercial, and
industrial uses.
P-25-0047............. 1 12/23/2024 Motiva Enterprises, (G) Intermediate... (G) Hydrocarbon,
LLC. processed.
P-25-0048............. 1 12/23/2024 Motiva Enterprises, (G) Intermediate... (G) Hydrocarbon,
LLC. processed.
P-25-0049............. 1 12/23/2024 Motiva Enterprises, (G) Intermediate... (G) Hydrocarbon,
LLC. processed.
P-25-0050............. 1 12/23/2024 Motiva Enterprises, (G) Additive for (G) Hydrocarbon,
LLC. consumer, processed.
commercial, and
industrial uses,
Intermediate.
P-25-0051............. 1 12/23/2024 Motiva Enterprises, (G) Additive for (G) Hydrocarbon,
LLC. consumer, processed.
commercial, and
industrial uses.
P-25-0052............. 1 12/23/2024 Motiva Enterprises, (G) Intermediate... (G) Hydrocarbon,
LLC. processed.
P-25-0053............. 1 12/23/2024 Motiva Enterprises, (G) Intermediate... (G) Hydrocarbon,
LLC. processed.
P-25-0054............. 1 12/23/2024 Motiva Enterprises, (G) Intermediate... (G) Hydrocarbon,
LLC. processed.
P-25-0055............. 1 12/23/2024 Motiva Enterprises, (G) Additive used (G) Hydrocarbon,
LLC. in industrial and processed.
commercial
applications.
P-25-0056............. 1 12/23/2024 Motiva Enterprises, (G) Intermediate... (G) Hydrocarbon,
LLC. processed.
P-25-0057............. 1 12/23/2024 Motiva Enterprises, (G) Intermediate... (G) Hydrocarbon,
LLC. processed.
SN-25-0002A........... 2 12/03/2024 CBI................ (G) Additive used (S) Cesium tungsten
in plastic panels. oxide.
SN-25-0003A........... 2 12/04/2024 CBI................ (S) Cathode Active (S) Phosphoric acid,
Material in iron (2+) lithium salt
Batteries. (1:1:1).
SN-25-0004............ 1 12/18/2024 CBI................ (G) Formulation (S) 1,3-Butanediol, (3R)-
into cosmetic .
products; Use as
monomer in polymer
industry.
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* The term `Approved' indicates that a submission has passed a quick initial screen ensuring all required
information and documents have been provided with the submission prior to the start of the 90-day review
period, and in no way reflects the final status of a complete submission review.
In Table 2 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, if applicable, of the type of amendment (e.g., amendment to
generic name, specific name, technical contact information, etc.); and
the chemical substance identity.
Table 2--NOCs Approved *
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Received Commencement If amendment, type
Case No. date date of amendment Chemical substance
----------------------------------------------------------------------------------------------------------------
P-13-0143A....................... 12/05/2024 03/11/2013 Submitter provided a (G) Alkanedioic acid,
new version due to polyisoalkylene
issues with first derivs., (alkylamino)
submission attempt alkyl esters.
in March 2013.
P-15-0046........................ 12/05/2024 11/19/2024 N/A................. (S) Propanol, oxybis-,
polymer with
bis(isocyanatomethyl)
cyclohexane and. alpha.
-hydro-. omega. -
hydroxypoly(oxy-1,4-
butanediyl).
P-18-0143........................ 11/27/2024 11/21/2024 N/A................. (S) Fatty acids, tall-
oil, polymers with N3-
(3-aminopropyl)-N1, N1-
dimethyl-1,3-
propanediamine,
polyethylenepolyamines
triethylenetetramine
fraction, and 2,4,6-
tris[(dimethylamino)met
hyl] phenol.
P-19-0148........................ 12/10/2024 11/11/2024 N/A................. (G) Iron, complexes with
ethylenediamine-4-
hydroxycarbomonocycle
hetero-acid-2-oxoacetic
acid reaction products,
potassium salts.
P-21-0180........................ 12/18/2024 12/16/2024 N/A................. (G) Sulfonium,
(heterosubstitutedpheny
l)diphenyl-, salt with
1-heterosubstituted-2-
methylalkyl
trisubstituted benzoate
(1:1).
[[Page 10489]]
P-24-0018........................ 12/03/2024 11/26/2024 N/A................. (S) 2-Propenoic acid, 2-
methyl-, butyl ester,
polymer with 2-
dodecylhexadecyl 2-
methyl-2-propenoate, 2-
oxepanonehomopolymer 2-
[(2-methyl-1-oxo-2-
propen-1-yl) oxy] ethyl
ester and 2-
tetradecyloctadecyl 2-
methyl-2-propenoate.
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* The term `Approved' indicates that a submission has passed a quick initial screen ensuring all required
information and documents have been provided with the submission.
In Table 3 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 3--Test Information Received
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Received
Case No. date Type of test information Chemical substance
----------------------------------------------------------------------------------------------------------------
P-10-0317; P-06-0494; P-09-0037; P-09- 12/31/2024 Measured amounts of C8 and (G) Fluoroalkyl acrylate
0511; P-06-0474; C10 impurities in copolymer; (G) Fluoroalkyl
P-06-0586; P-07-0447.................. representative samples. methacrylate copolymer; (G)
Fluoroalkyl methacrylate
copolymer; (G) Fluoroalkyl
acrylate copolymer; (G)
Fluoroalkyl acrylate
copolymer; (G) Fluoroalkyl
methacrylate co-polymer; (G)
Fluoroalkyl acrylate
copolymer.
P-13-0679; P-13-0646; P-13-0647; P-13- 12/31/2024 Measures amounts of (G) Fluoroalkyl acrylate
0648; P-13-0678; impurities in copolymer; (G) Fluoroalkyl
P-15-0154............................. representative samples. acrylate copolymer modified
with polysiloxanes; (G)
Fluoroalkyl acrylate
copolymer; (G) Fluoroalkyl
acrylate copolymer modified
with polysiloxanes; (G)
Fluoroalkyl methylacrylate
copolymer; (G) Perfluorinated
polymer with potential [C6]
ultimate degradant.
P-14-0712.............................. 12/13/2024 Polychlorinated (S) Waste plastics, pyrolyzed,
Dibenzodioxins and C5-55 fraction.
Polychlorinated
dibenzofurans Testing.
P-16-0543.............................. 12/18/2024 Exposure Monitoring Report (G) Halogenophosphoric acid
metal salt.
P-19-0166.............................. 12/12/2024 Determination of n-Octanol/ (G) Triarylsulfonium
Water Partition alkylestersulfonate.
Coefficient (Slow Stir
Method).
P-20-0174.............................. 12/05/2024 OECD 120 study (S) 6-Octen-1-ol, 3,7-dimethyl-
(Determination of , homopolymer, monoacetate.
Solution/Extraction
Behavior in Water).
P-25-0025.............................. 12/16/2024 Acute Oral Toxicity (AOT) (G) Carbomonocyclic alcohol,
(OECD Test Guideline 420). 4,4- [[6-(heteroatom-
substituted carbomonocycle)-
heteromonocycle-2,4-diyl]
heteroatom-substituted] bis-.
P-25-0026.............................. 12/10/2024 Study Report.............. (G) Bi-heteromonocycle,
polyoxide.
SN-24-0004............................. 12/05/2024 Oral Gavage in Vivo (S) Oxirane, 2,2'-[1,6-
Mutation Assay; Extended hexanediylbis(oxymethylene)]
One Generation bis-.
Reproductive Toxicity
Study in the Sprague
Dawley Rat by Oral Gavage
Administration with
Extension to F2
Generation.
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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: February 14, 2025.
Todd Holderman,
Deputy Director, Project Management and Operations Division, Office of
Pollution Prevention and Toxics.
[FR Doc. 2025-02994 Filed 2-21-25; 8:45 am]
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