Notice2024-00891
Certain New Chemicals; Receipt and Status Information for December 2023
Primary source
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Published
January 18, 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 12/01/ 2023 to 12/31/2023.
Full Text
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<title>Federal Register, Volume 89 Issue 12 (Thursday, January 18, 2024)</title>
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[Federal Register Volume 89, Number 12 (Thursday, January 18, 2024)]
[Notices]
[Pages 3397-3401]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-00891]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2023-0061; FRL-10581-12-OCSPP]
Certain New Chemicals; Receipt and Status Information for
December 2023
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 12/01/
2023 to 12/31/2023.
DATES: Comments identified by the specific case number provided in this
document must be received on or before February 20, 2024.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2023-0061, 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) 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#2b594a434a42054142466b4e5b4a054c445d"><span class="__cf_email__" data-cfemail="9fedfef7fef6b1f5f6f2dffaeffeb1f8f0e9">[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#792d2a3a385431160d1510171c391c0918571e160f"><span class="__cf_email__" data-cfemail="9ecacddddfb3d6f1eaf2f7f0fbdefbeeffb0f9f1e8">[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 12/01/2023 to 12/31/2023. 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);
[[Page 3398]]
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 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 12/01/2023 to 12/31/2023
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Case No. Version Received date Manufacturer Use Chemical substance
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J-24-0001......................... 1 12/13/2023 CBI.................. (G) Chemical (G) Chromosomally-modified
production. Saccharomyces cerevisiae.
J-24-0002......................... 1 12/13/2023 CBI.................. (G) Chemical (G) Chromosomally-modified
production. Saccharomyces cerevisiae.
P-16-0404A........................ 7 12/01/2023 CBI.................. (G) A colorant for (G) Alkyl ester, 2-({4-[2-
dyeing various (trisubstituted phenyl)azo]-5-
synthetic fibers and acetamido-2-
fabrics. Open, non- substitutedphenyl{time}
dispersive use. (substituted alkoxy)amino).
P-20-0092A........................ 9 12/01/2023 CBI.................. (G) Coloration of (G) Napthalenesulfonic acid,
fabric. amino-hydroxy-bis [sulfo-
[(sulfooxy)ethyl]sulfonyl]phen
yl]diazinyl]-,potassium sodium
salt.
P-22-0002A........................ 5 12/06/2023 Materion Advanced (G) This product is (G) Metal Oxide Chloride.
Chemicals. used for the
manufacturing of
electronic devices.
P-22-0011A........................ 6 12/20/2023 CBI.................. (G) Functionalized (G) Alkadiene, homopolymer,
rubber in resin side hydroxy-terminated, bis[N-[2-
of two component [(1-oxo-2-propen-1-
epoxy modified yl)oxylethyl]carbamates].
acrylic adhesive.
P-22-0113A........................ 6 12/12/2023 Solugen, Inc......... (G) Chemical (S) D-Glucaric acid.
intermediate,
Additive.
P-23-0148......................... 1 06/22/2023 CBI.................. (G) Inert component (G) Amylopectin, 2-
in Pesticides. hydroxypropyl ether, modified.
[[Page 3399]]
P-23-0172A........................ 3 12/18/2023 CBI.................. (G) Photolithography. (G) Sulfonium, tricarbocyclic-,
alkylcarbomonocyclic-
polyfluoro-heteropolycyclic-
alkyl sulfonate (1:1), polymer
with alkylaryl and
carbomonocyclic alkyl
alkanoate, di-Me 2,2'-(1,2-
diazenediyl)bis[2-
alkylalkanoate]-initiated.
P-24-0006......................... 2 12/19/2023 CBI.................. (S) Oilfield (G) Polymeric salt of Propenoic
Production Scale acid, Acrylamido-methylpropane
Inhibitor. sulfonic acid sodium salt,
Hydroxyethyl methacrylate,
Methyl methacrylate, Propenoic
acid, methyl-,
phosphinicobis(oxy-ethanediyl)
ester, Sodium Metabisulfite.
P-24-0016......................... 3 11/29/2023 Huntsman (S) Catalyst in 2- (S) 2-Propanamine, N ,N'-(oxydi-
International, LLC. part polyurethane 2,1-ethanediyl)bis[N-methyl-.
spray foam
insulation
application.
P-24-0034......................... 1 11/27/2023 Barentz North (S) Elcosol DM has (S) 2,5,7,10-Tetraoxaundecane,
America, LLC. widespread use as a 4,8-dimethyl-.
non-reactive
processing aid (no
inclusion into or
onto article), the
substance is not
included in the
final article as it
evaporates. There is
no intended consumer
use for this
application.
(S) In cleaning
products, Elcosol DM
has widespread use
as a non-reactive
processing aid (no
inclusion into or
onto article). The
substance is not
included in the
final article it is
recycled or
recuperated for
treatment/
appropriate
disposal; waters are
treated through a
biological sewage
treatment process
(STP). In consumer
products the NCS is
used as a solvent or
cosolvent.
(S) For use in
laboratories,
Elcosol DM is not
included in the
final article: it is
recycled or
recuperated for
treatment/
appropriate
disposal, waters are
treated through a
biological sewage
treatment process
(STP). There is no
consumer use of this
NCS for this
application.
(S) Elcosol DM is
used in consumer
cleaning products as
a solvent or
cosolvent. The use
of the substance by
consumers is
expected to fall
under do-it yourself
(DIY) cleaning
products such as
glue removers, paint
strippers, hard
stain removers.
P-24-0036......................... 3 12/18/2023 CBI.................. (G) Intermediate..... (G) Poly(oxy-alkylene), alpha-
alkenyl-omega-hydroxy-,.
P-24-0040......................... 2 12/15/2023 Sudoc, LLC........... (G) Additive for (G) Metal,
commercial aqua[(alkylnitrocarbocyclepoly
applications. heteropolyheterocyclopolyalkan
Additive for non- e-ketone)-polyoxidato]-,
spray commercial and metal.
consumer
applications.
P-24-0042......................... 1 12/15/2023 CBI.................. (G) An ingredient (G) Sulfonium,
used in the bis(dihalocarbomonocycle)carbo
manufacture of monocycle-, salt with (dihalo-
photoresist. sulfoalkyl) (halo-substituted
carbomonocycle)
carbopolycycle.
P-24-0043......................... 1 12/19/2023 Clariant Corporation. (S) Catalyst for use (S) Iron potassium oxide
in petrochemical (FeKO2).
operations.
P-24-0044......................... 1 12/21/2023 CBI.................. (G) Component in (G) Oxirane, 2-methyl-, polymer
polyurethane and with oxirane, ether with N-[4-
other thermoset [[4-[bis(2-
resins. hydroxyethyl)amino]phenyl](2-
substitutedphenyl)methylene]-
2,5-cyclohexadien-1-ylidene]-2-
hydroxy-N-(2-
hydroxyethyl)ethanaminium
inner salt (4:1).
P-24-0045......................... 1 12/21/2023 CBI.................. (G) Coating and (G) Cashew, nutshell liq.,
Adhesives. polymer with epichlorohydrin
and glycol.
SN-22-0007A....................... 6 12/29/2023 Braven Environmental, (G) Product of (S) Waste plastics, pyrolyzed,
LLC. Pyrolysis C5-12 fraction.
manufacturing.
SN-22-0008A....................... 6 12/29/2023 Braven Environmental, (G) Product of (S) Waste plastics, pyrolyzed,
LLC. Pyrolysis C20-55 fraction.
Manufacturing.
[[Page 3400]]
SN-22-0009A....................... 6 12/29/2023 Braven Environmental, (G) Product of (S) Waste plastics, pyrolyzed,
LLC. Pyrolysis C9-20 fraction.
Manufacturing.
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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 12/01/2023 to 12/31/2023
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Received Commencement If amendment, type
Case No. date date of amendment Chemical substance
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P-21-0168........................ 12/28/2023 12/04/2023 N................... (G) Metal,
[heteropolycyclic]-,
[[[(hydroxyalkyl)amino]
sulfonyl]alkyl]sulfonyl
(sulfoalkyl)sulfonyl
derivs., ammonium
sodium salts,.
P-22-0054........................ 12/19/2023 10/17/2023 N................... (G) Graphene
nanoplatelets.
P-22-0127........................ 12/14/2023 12/01/2023 N................... (S) Urea, n,n'-bis[3-
[[(4-
methylphenyl)sulfonyl]o
xy]phenyl]-.
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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 12/01/2023 to 12/31/2023
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Received
Case No. date Type of test information Chemical substance
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P-17-0339................................ 12/19/2023 Simulation Test--Aerobic (S) Poly(oxy-1,2-
Sewage Treatment--A: ethanedlyl)-alpha-(2-butyl
Activated Sludge Units (1-octyl \14\C))-omega-
(OECD Test Guideline 303A). hydroxy alcohol.
P-19-0166................................ 12/06/2023 Partition Coefficient (n- (G) Triarylsulfonium
octanol/water), Shake alkylestersulfonate,.
Flask Method (OECD Test
Guideline 107); Partition
Coefficient (n-octanol/
water), Estimation by
Liquid Chromatography
(OECD Test Guideline 117).
P-23-0165................................ 12/15/2023 Combined Repeated Dose (G) 2,3,3,3-tetrafluoro-2-
Toxicity with the [(polyfluoroalken-1-
Reproduction/Development yl)oxy]-propanoic acid
Toxicity Screening Test homopolymer.
(OECD Test Guideline 422).
P-10-0470................................ 12/19/2023 Analytical Information..... (G) Fluoro modified,
polyether modified and
alkyl modified
polymethylsiloxane.
P-10-0471................................ 12/19/2023 Analytical Information..... (G) Fluoro modified,
polyether modified
polyacrylate.
P-10-0472................................ 12/19/2023 Analytical Information..... (G) Fluoro modified,
polyether modified
polyacrylate.
P-20-0042, P-18-0016..................... 12/4/2023 Direct Photolysis Study (G) Sulfonium, trisaryl-,
Report. 7,7-dialkyl-2-
heteropolycyclic-1-
alkanesulfonate (1:1); (G)
Aromatic sulfonium
tricyclo fluoroalkyl
sulfonic acid salt.
P-18-0304, P-18-0316, P-18-0338, P-19- 12/12/2023 PAG 2 Direct Photolysis (G) Sulfonium,
0076, P-19-0115, P-19-0142, P-20-0120, P- Study Report. bis(dihalocarbomonocycle)
21-0027. carbomonocycle, salt with
substituted
heteropolycycle dihalo
sulfoalkanoate (1:1).
(G) Heteropolycycle,
alkylaromatic-, salt with
dihalo-substituted alkyl
carbopolycycle
carboxylate.
(G) Sulfonium, triaryl-,
salt with polyhalo-4-
sulfoalkyl polycarbocyclic
alkane-1-carboxylate
(1:1).
(G) Sulfonium,
bis(dihalocarbomonocycle)
carbomonocycle, salt with
dihalo substituted alkyl
carbopolycyclic
carboxylate (1:1).
(G) Sulfonium,
bis(dihalocarbomonocycle)
carbomonocycle,
substituted
carbomonocyclic ester.
(G) Heteropolycycle,
aromatic-, salt with
dihalo-substituted alkyl
carbopolycycle carboxylate
(1:1).
(G) Carbomonocyclic
sulfonium, salt with
trihalo-sulfoalkyl
hydroxycarbopolycyclic
carboxylate.
(G) Heteropolycyclic,
trihaloalkyl
carbomonocycle-, hydroxy
carbomonocyclic salt.
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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.
[[Page 3401]]
Dated: January 11, 2024.
Pamela Myrick,
Director, Project Management and Operations Division, Office of
Pollution Prevention and Toxics.
[FR Doc. 2024-00891 Filed 1-17-24; 8:45 am]
BILLING CODE 6560-50-P
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