Certain New Chemicals; Receipt and Status Information for July 2024, 68899-68902 [2024-19304]
Download as PDF
Federal Register / Vol. 89, No. 167 / Wednesday, August 28, 2024 / Notices
EPA as much time as possible to process
your request.
Lorraine Reddick,
Designated Federal Officer, Office of Air
Policy and Program Support.
[FR Doc. 2024–19326 Filed 8–27–24; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–OPPT–2024–0057; FRL–11683–
07–OCSPP]
Certain New Chemicals; Receipt and
Status Information for July 2024
I. Executive Summary
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
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 7/01/2024 to 7/
31/2024.
DATES: Comments identified by the
specific case number provided in this
document must be received on or before
September 27, 2024.
ADDRESSES: Submit your comments,
identified by docket identification (ID)
number EPA–HQ–OPPT–2024–0057,
through the Federal eRulemaking Portal
at https://www.regulations.gov. 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
https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: For
technical information contact: Jim
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
18:13 Aug 27, 2024
Jkt 262001
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: rahai.jim@
epa.gov. For general information
contact: The TSCA-Hotline, ABVIGoodwill, 422 South Clinton Ave.,
Rochester, NY 14620; telephone
number: (202) 554–1404; email address:
TSCA-Hotline@epa.gov.
SUPPLEMENTARY INFORMATION:
A. What action is the Agency taking?
This document provides the receipt
and status reports for the period from 7/
01/2024 to 7/31/2024. 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-chemicalsunder-toxic-substances-control-act-tsca/
status-pre-manufacture-notices. 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: https://
www.epa.gov/tsca-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
PO 00000
Frm 00051
Fmt 4703
Sfmt 4703
68899
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/chemicals-undertsca.
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
regulations.gov 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
E:\FR\FM\28AUN1.SGM
28AUN1
68900
Federal Register / Vol. 89, No. 167 / Wednesday, August 28, 2024 / Notices
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
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, 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: https://
www.epa.gov/reviewing-new-chemicalsunder-toxic-substances-control-act-tsca/
status-pre-manufacture-notices. 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 7/01/2024 TO 7/31/2024
khammond on DSKJM1Z7X2PROD with NOTICES
Case No.
Version
Received
date
Manufacturer
Use
Chemical substance
(G) Perfluorinated substituted 1,3-oxathiolane dioxide.
(G) Perfluorinated vinyl haloalkane sulfonate salt.
(G) Perfluorinated vinyl haloalkane sulfonyl halide.
(G) [Polyalkyl-methylenepolyhydro-polycyclic]alkyl
acetate.
(G) fatty acids, vegetable oil, reaction products with
diethylenetriamine.
(S) Fatty acids, C8-14, 2,3-diesters with rel-(2R,
3S)-2,3,4-trihydroxybutyl Beta-Dmannopyranoside acetate.
(G) Alkyated succinimide.
(G) Alkyated succinimide.
(G) carbomonocycle alkylamide, 3,5-bis(1,1-dialkyl)
-4-hydroxy-N-[2,5-dioxo-3-(polyalkylene)-1heteromonocyclic]-.
(G) Lithium dihalo (oxalato)borate(1-).
(G) Lithium dihalo (oxalato)borate(1-).
(G) poly(alkoxy)alkanol.
(S) Fats and glyceridic oils, camelina sativa. Extractives and their physically modified derivatives. It
consists primarily of the glycerides of the fatty
acids docosenoic, eicosenoic, linoleic, linolenic,
oleic, palmitic and stearic. (Camelina sativa).
(S) Fats and glyceridic oils, camelina sativa. Extractives and their physically modified derivatives. It
consists primarily of the glycerides of the fatty
acids docosenoic, eicosenoic, linoleic, linolenic,
oleic, palmitic and stearic. (Camelina sativa).
P–20–0031 .............
1
07/17/2024
CBI ...................................
(G) Intermediate ...........................
P–20–0033 .............
P–20–0034 .............
P–23–0014 .............
1
1
1
07/17/2024
07/17/2024
07/22/2024
CBI ...................................
CBI ...................................
CBI ...................................
(G) Intermediate ...........................
(G) Intermediate ...........................
.......................................................
P–23–0177A ..........
3
07/19/2024
Colonial Chemical, Inc .....
(G) Corrosion inhibitor ..................
P–24–0027A ..........
6
07/08/2024
Mikros Biochem ...............
(S) Surfactant for cleaners ...........
P–24–0079A ..........
P–24–0079A ..........
P–24–0104A ..........
4
5
5
07/12/2024
07/19/2024
07/17/2024
CBI ...................................
CBI ...................................
CBI ...................................
(G) Fuel Additive ..........................
(G) Fuel Additive ..........................
(G) Plastic Additive ......................
P–24–0109A
P–24–0109A
P–24–0130A
P–24–0161A
..........
..........
..........
..........
3
4
3
3
07/09/2024
07/10/2024
07/12/2024
06/27/2024
CBI ...................................
CBI ...................................
CBI ...................................
Cargill, Incorporated ........
(G) Electrolyte salt .......................
(G) Electrolyte salt .......................
(S) Sulfur Scavenger ....................
(S) Feedstock for production of
biofuel.
P–24–0161A ..........
4
07/08/2024
Cargill, Incorporated ........
(S) Feedstock for production of
biofuel.
VerDate Sep<11>2014
18:13 Aug 27, 2024
Jkt 262001
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
E:\FR\FM\28AUN1.SGM
28AUN1
Federal Register / Vol. 89, No. 167 / Wednesday, August 28, 2024 / Notices
68901
TABLE I—PMN/SNUN/MCANS APPROVED * FROM 7/01/2024 TO 7/31/2024—Continued
Case No.
Received
date
Version
Manufacturer
Use
(S) Increases strength of epoxy,
plastics, moulding compounds,
strength, modulus, tear resistance for polyurethane foam;
Improves the rutting behavior of
asphalt; Improves the capacity
and thermal and electrical conductivity for batteries, strength
of body armor and helmets,
drying time and antifouling for
paints.
(S) Intermediate in the production
of a catalyst.
(G) Making of air pollutants control parts in automobiles.
(G) Manufacturing of air pollutants control parts.
(G) For making air pollutant control parts in automobiles.
(G) Making air pollutants control
parts in automobiles.
(G) Air pollutants control parts in
automobiles.
(G) Making of air pollutants control parts in automobiles.
(G) Air pollutants control parts in
automobiles.
(G) Paints and coatings, home
and personal care, metal working fluids, electronics.
(G) Chemical intermediate ...........
P–24–0162A ..........
3
07/25/2024
Proton Power, Inc ............
P–24–0164A ..........
2
07/09/2024
P–24–0171A ..........
2
07/17/2024
Huntsman International,
LLC.
CBI ...................................
P–24–0172A ..........
2
07/17/2024
CBI ...................................
P–24–0173 .............
1
07/12/2024
CBI ...................................
P–24–0174 .............
1
07/12/2024
CBI ...................................
P–24–0175 .............
1
07/12/2024
CBI ...................................
P–24–0176 .............
1
07/12/2024
CBI ...................................
P–24–0177 .............
1
07/12/2024
CBI ...................................
P–24–0178 .............
1
07/15/2024
Advancion ........................
P–24–0183 .............
1
07/25/2024
HPC Holdings, Inc ...........
SN–24–0007A ........
2
07/22/2024
CBI ...................................
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
Chemical substance
(G) Additive for plastic, Intermediate.
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
(S) single and multilayer turbostratic graphene.
(S) 2-Propanamine, N,N′-(oxydi-2,1-ethanediyl)bis-.
(G) Metal and rare earth metal zirconium oxide.
(G) Metal and rare earth metal zirconium oxide.
(G) Rare earth doped zirconium oxide
(G) Rare earth doped zirconium oxide.
(G) Rare earth doped zirconium oxide.
(G) Rare earth doped zirconium oxide.
(G) Rare earth doped zirconium oxide.
(S) 2-Butanol, 3-amino-3-methyl.
(S) 1-Butanone, 4,4,4-trifluoro-3-hydroxyl-1-(2naphthalenyl)-3-(trifluoromethyl)-.
(G) Inorganic acid, metal salt, compd. with substituted aromatic heterocycle.
type of amendment (e.g., amendment to
generic name, specific name, technical
contact information, etc.) and chemical
substance identity.
TABLE II—NOCS APPROVED * FROM 7/01/2024 TO 7/31/2024
khammond on DSKJM1Z7X2PROD with NOTICES
Case No.
Received date
Commencement
date
If amendment,
type of
amendment
P–18–0172 .....
P–22–0005A ...
P–22–0083 .....
07/17/2024
07/22/2024
07/16/2024
08/28/2019
07/12/2024
07/04/2024
N .....................
N .....................
N .....................
P–22–0192 .....
06/27/2024
06/20/2024
N .....................
P–23–0124 .....
06/27/2024
06/20/2024
N .....................
P–23–0126 .....
P–23–0135 .....
P–23–0172 .....
07/15/2024
07/15/2024
06/27/2024
07/08/2024
07/08/2024
06/20/2024
N .....................
N .....................
N .....................
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
Chemical substance
(S) Calcium, carbonate 2-ethylhexanoate neodecanoate propionate complexes.
(S) Formic acid, compd. with 2-methyl-1,5-pentanediamine (2:1).
(S) Oils, sandalwood, santalene synthase-modified Rhodobacter sphaeroides-fermented, from D-Glucose, oxidized.
(G) Sulfonium, tricarbocyclic-, polyfluoro-heteroatom-substituted
polycarbocyclicalkanesulfonate (1:1).
(G) Sulfonium, tricabocyclic-, 2-heteroatom-substituted-(halocarbocyclic)carboxylate
(1:1).
(G) Alken-1-ol.
(G) Alken-1-ol, 1-acetate.
(G) Sulfonium, tricarbocyclic-, alkylcarbomocyclic-polyfluoro-heteropolycyclic-alkyl
sulfonate (1:1), polymer with alkylaryl and carbomonocyclic alkylalkanoate, di-Me 2,2′(1,2-diazenediyl)bis(2-alkylalkanoate)-initiated.
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 7/01/2024 TO 7/31/2024
Case No.
L–23–0173 .....................
VerDate Sep<11>2014
Received
date
07/09/2024
18:13 Aug 27, 2024
Jkt 262001
Type of test information
Chemical substance
Algal Toxicity (OECD Test Guideline 201) ............
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
(G) Cis-alkenoic acid.
E:\FR\FM\28AUN1.SGM
28AUN1
68902
Federal Register / Vol. 89, No. 167 / Wednesday, August 28, 2024 / Notices
TABLE III—TEST INFORMATION RECEIVED FROM 7/01/2024 TO 7/31/2024—Continued
Case No.
Received
date
P–14–0712 .....................
07/10/2024
P–18–0124 .....................
07/08/2024
P–21–0202, P–23–0104
07/23/2024
P–24–0154 .....................
07/12/2024
P–24–0154 .....................
07/12/2024
Type of test information
Polychlorinated Dibenzodioxins and Polychlorinated dibenzofurans Testing.
90-Day Inhalation Toxicity (OECD Test Guideline
413).
Determination of Dissociation Constant
(Conductometric Method; OECD Guideline 112
OPPTS 830.7370).
Melting Point/Melting Range (OECD Test Guideline 102); Boiling Point/Boiling Range (OECD
Test Guideline 103); Storage Stability (OECD
Test Guideline 113); Combined Repeated Dose
Toxicity with the Reproduction/Development
Toxicity Screening Test (OECD Test Guideline
422); Particle Size, Fiber Length, Diameter Distribution (OECD Test Guideline 110); Density/
Relative Density/Bulk Density (OECD Test
Guideline 109); In Vitro Skin Irritation Testing;
Primary Skin Irritation Testing in Rabbits.
Acute Oral Toxicity (OECD Test Guideline 423);
Acute Eye Irritation (OECD Test Guideline 405);
Bovine Corneal Opacity and Permeability Test
Method for Identifying i) Chemicals Inducing
Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage (OECD Test Guideline 437);
In Vitro Mammalian Chromosome Aberration
Test (OECD Test Guideline 473); Skin Sensitization (OECD Test Guideline 429); Flammability Testing; Bacterial Reverse Mutation Test
(OECD Test Guideline 471).
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: August 22, 2024.
Pamela Myrick,
Director, Project Management and Operations
Division, Office of Pollution Prevention and
Toxics.
[FR Doc. 2024–19304 Filed 8–27–24; 8:45 am]
BILLING CODE 6560–50–P
FEDERAL MARITIME COMMISSION
khammond on DSKJM1Z7X2PROD with NOTICES
Notice of Agreements Filed
The Commission hereby gives notice
of filing of the following agreement
under the Shipping Act of 1984.
Interested parties may submit
comments, relevant information, or
documents regarding the agreement to
the Secretary by email at Secretary@
fmc.gov, or by mail, Federal Maritime
Commission, 800 North Capitol Street,
Washington, DC 20573. Comments will
VerDate Sep<11>2014
18:13 Aug 27, 2024
Jkt 262001
Chemical substance
(S) Waste plastics, pyrolyzed, C5-55 fraction.
(S) Lithium nickel potassium oxide.
(G) Sulfonium, carbomonocycle
bis[(trihaloalkyl)carbomonocycle], substituted
carbomonocyclic ester; (G) Sulfonium,
carbomonocycle
bis[(trihaloalkyl)carbomonocycle], disubstituted
carbomonocyclic ester.
(G) Polyphenyl, ethoxy-polyfluoro-alkyl-.
(G) Polyphenyl, ethoxy-polyfluoro-alkyl-.
be most helpful to the Commission if
received within 12 days of the date this
notice appears in the Federal Register,
and the Commission requests that
comments be submitted within 7 days
on agreements that request expedited
review. Copies of agreement are
available through the Commission’s
website (www.fmc.gov) or by contacting
the Office of Agreements at (202)–523–
5793 or tradeanalysis@fmc.gov.
Agreement No.: 001941–005.
Agreement Name: Baltimore Marine
Terminal Association.
Parties: Balterm LLC; Mid-Atlantic
Terminal, LLC; Ports America
Baltimore, Inc.; Ports America
Chesapeake, LLC; SSA Atlantic, LLC.
Filing Party: Michael J. Collins; Law
Offices of Michael J. Collins, PC.
Synopsis: There are three
modifications. First, Ports America
Baltimore, Inc. (‘‘PAB’’) was
inadvertently omitted from the 2018
filing (it was included in the 2017
Agreement). The amendment corrects
this mistake. PAB has been a member
continuously included on the BMTA
tariff, notwithstanding the error in 2018
that deleted PAB. Second, SSA Atlantic,
LLC (‘‘SSA’’) acquired Ceres Terminals
Corporation (‘‘Ceres’’) and is the
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
surviving entity. Third, Ceres has been
removed as a member, and SSA has
been substituted as a member of the
BMTA. SSA has updated its FMC–1.
Proposed Effective Date: 10/03/2024.
Location: https://www2.fmc.gov/FMC.
Agreements.Web/Public/Agreement
History/2109.
Dated: August 23, 2024.
Alanna Beck,
Federal Register Alternate Liaison Officer.
[FR Doc. 2024–19346 Filed 8–27–24; 8:45 am]
BILLING CODE 6730–02–P
FEDERAL RESERVE SYSTEM
Change in Bank Control Notices;
Acquisitions of Shares of a Bank or
Bank Holding Company
The notificants listed below have
applied under the Change in Bank
Control Act (Act) (12 U.S.C. 1817(j)) and
§ 225.41 of the Board’s Regulation Y (12
CFR 225.41) to acquire shares of a bank
or bank holding company. The factors
that are considered in acting on the
applications are set forth in paragraph 7
of the Act (12 U.S.C. 1817(j)(7)).
E:\FR\FM\28AUN1.SGM
28AUN1
Agencies
[Federal Register Volume 89, Number 167 (Wednesday, August 28, 2024)]
[Notices]
[Pages 68899-68902]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-19304]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2024-0057; FRL-11683-07-OCSPP]
Certain New Chemicals; Receipt and Status Information for July
2024
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
-----------------------------------------------------------------------
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 7/01/
2024 to 7/31/2024.
DATES: Comments identified by the specific case number provided in this
document must be received on or before September 27, 2024.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2024-0057, through the Federal eRulemaking
Portal at https://www.regulations.gov. 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 https://www.epa.gov/dockets.
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: [email protected]. For general
information contact: 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 7/01/2024 to 7/31/2024. 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. 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: https://www.epa.gov/tsca-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/chemicals-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 confidential business information (CBI). Do not
submit this information to EPA through regulations.gov 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
[[Page 68900]]
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 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, 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: https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/status-pre-manufacture-notices. 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 7/01/2024 to 7/31/2024
----------------------------------------------------------------------------------------------------------------
Received
Case No. Version date Manufacturer Use Chemical substance
----------------------------------------------------------------------------------------------------------------
P-20-0031............... 1 07/17/2024 CBI............... (G) Intermediate.. (G) Perfluorinated
substituted 1,3-
oxathiolane dioxide.
P-20-0033............... 1 07/17/2024 CBI............... (G) Intermediate.. (G) Perfluorinated
vinyl haloalkane
sulfonate salt.
P-20-0034............... 1 07/17/2024 CBI............... (G) Intermediate.. (G) Perfluorinated
vinyl haloalkane
sulfonyl halide.
P-23-0014............... 1 07/22/2024 CBI............... .................. (G) [Polyalkyl-
methylenepolyhydro-
polycyclic]alkyl
acetate.
P-23-0177A.............. 3 07/19/2024 Colonial Chemical, (G) Corrosion (G) fatty acids,
Inc. inhibitor. vegetable oil,
reaction products with
diethylenetriamine.
P-24-0027A.............. 6 07/08/2024 Mikros Biochem.... (S) Surfactant for (S) Fatty acids, C8-14,
cleaners. 2,3-diesters with rel-
(2R, 3S)-2,3,4-
trihydroxybutyl Beta-D-
mannopyranoside
acetate.
P-24-0079A.............. 4 07/12/2024 CBI............... (G) Fuel Additive. (G) Alkyated
succinimide.
P-24-0079A.............. 5 07/19/2024 CBI............... (G) Fuel Additive. (G) Alkyated
succinimide.
P-24-0104A.............. 5 07/17/2024 CBI............... (G) Plastic (G) carbomonocycle
Additive. alkylamide, 3,5-
bis(1,1-dialkyl) -4-
hydroxy-N-[2,5-dioxo-3-
(polyalkylene)-1-
heteromonocyclic]-.
P-24-0109A.............. 3 07/09/2024 CBI............... (G) Electrolyte (G) Lithium dihalo
salt. (oxalato)borate(1-).
P-24-0109A.............. 4 07/10/2024 CBI............... (G) Electrolyte (G) Lithium dihalo
salt. (oxalato)borate(1-).
P-24-0130A.............. 3 07/12/2024 CBI............... (S) Sulfur (G)
Scavenger. poly(alkoxy)alkanol.
P-24-0161A.............. 3 06/27/2024 Cargill, (S) Feedstock for (S) Fats and glyceridic
Incorporated. production of oils, camelina sativa.
biofuel. Extractives and their
physically modified
derivatives. It
consists primarily of
the glycerides of the
fatty acids
docosenoic,
eicosenoic, linoleic,
linolenic, oleic,
palmitic and stearic.
(Camelina sativa).
P-24-0161A.............. 4 07/08/2024 Cargill, (S) Feedstock for (S) Fats and glyceridic
Incorporated. production of oils, camelina sativa.
biofuel. Extractives and their
physically modified
derivatives. It
consists primarily of
the glycerides of the
fatty acids
docosenoic,
eicosenoic, linoleic,
linolenic, oleic,
palmitic and stearic.
(Camelina sativa).
[[Page 68901]]
P-24-0162A.............. 3 07/25/2024 Proton Power, Inc. (S) Increases (S) single and
strength of multilayer
epoxy, plastics, turbostratic graphene.
moulding
compounds,
strength,
modulus, tear
resistance for
polyurethane
foam; Improves
the rutting
behavior of
asphalt; Improves
the capacity and
thermal and
electrical
conductivity for
batteries,
strength of body
armor and
helmets, drying
time and
antifouling for
paints.
P-24-0164A.............. 2 07/09/2024 Huntsman (S) Intermediate (S) 2-Propanamine, N,N'-
International, in the production (oxydi-2,1-
LLC. of a catalyst. ethanediyl)bis-.
P-24-0171A.............. 2 07/17/2024 CBI............... (G) Making of air (G) Metal and rare
pollutants earth metal zirconium
control parts in oxide.
automobiles.
P-24-0172A.............. 2 07/17/2024 CBI............... (G) Manufacturing (G) Metal and rare
of air pollutants earth metal zirconium
control parts. oxide.
P-24-0173............... 1 07/12/2024 CBI............... (G) For making air (G) Rare earth doped
pollutant control zirconium oxide
parts in
automobiles.
P-24-0174............... 1 07/12/2024 CBI............... (G) Making air (G) Rare earth doped
pollutants zirconium oxide.
control parts in
automobiles.
P-24-0175............... 1 07/12/2024 CBI............... (G) Air pollutants (G) Rare earth doped
control parts in zirconium oxide.
automobiles.
P-24-0176............... 1 07/12/2024 CBI............... (G) Making of air (G) Rare earth doped
pollutants zirconium oxide.
control parts in
automobiles.
P-24-0177............... 1 07/12/2024 CBI............... (G) Air pollutants (G) Rare earth doped
control parts in zirconium oxide.
automobiles.
P-24-0178............... 1 07/15/2024 Advancion......... (G) Paints and (S) 2-Butanol, 3-amino-
coatings, home 3-methyl.
and personal
care, metal
working fluids,
electronics.
P-24-0183............... 1 07/25/2024 HPC Holdings, Inc. (G) Chemical (S) 1-Butanone, 4,4,4-
intermediate. trifluoro-3-hydroxyl-1-
(2-naphthalenyl)-3-
(trifluoromethyl)-.
SN-24-0007A............. 2 07/22/2024 CBI............... (G) Additive for (G) Inorganic acid,
plastic, metal salt, compd.
Intermediate. with substituted
aromatic heterocycle.
----------------------------------------------------------------------------------------------------------------
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 7/01/2024 to 7/31/2024
--------------------------------------------------------------------------------------------------------------------------------------------------------
If amendment, type of
Case No. Received date Commencement date amendment Chemical substance
--------------------------------------------------------------------------------------------------------------------------------------------------------
P-18-0172............................... 07/17/2024 08/28/2019 N........................... (S) Calcium, carbonate 2-ethylhexanoate
neodecanoate propionate complexes.
P-22-0005A.............................. 07/22/2024 07/12/2024 N........................... (S) Formic acid, compd. with 2-methyl-1,5-
pentanediamine (2:1).
P-22-0083............................... 07/16/2024 07/04/2024 N........................... (S) Oils, sandalwood, santalene synthase-
modified Rhodobacter sphaeroides-
fermented, from D-Glucose, oxidized.
P-22-0192............................... 06/27/2024 06/20/2024 N........................... (G) Sulfonium, tricarbocyclic-, polyfluoro-
heteroatom-substituted
polycarbocyclicalkanesulfonate (1:1).
P-23-0124............................... 06/27/2024 06/20/2024 N........................... (G) Sulfonium, tricabocyclic-, 2-
heteroatom-substituted-
(halocarbocyclic)carboxylate (1:1).
P-23-0126............................... 07/15/2024 07/08/2024 N........................... (G) Alken-1-ol.
P-23-0135............................... 07/15/2024 07/08/2024 N........................... (G) Alken-1-ol, 1-acetate.
P-23-0172............................... 06/27/2024 06/20/2024 N........................... (G) Sulfonium, tricarbocyclic-,
alkylcarbomocyclic-polyfluoro-
heteropolycyclic-alkyl sulfonate (1:1),
polymer with alkylaryl and
carbomonocyclic alkylalkanoate, di-Me
2,2'-(1,2-diazenediyl)bis(2-
alkylalkanoate)-initiated.
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 7/01/2024 to 7/31/2024
----------------------------------------------------------------------------------------------------------------
Received
Case No. date Type of test information Chemical substance
----------------------------------------------------------------------------------------------------------------
L-23-0173............................ 07/09/2024 Algal Toxicity (OECD Test (G) Cis-alkenoic acid.
Guideline 201).
[[Page 68902]]
P-14-0712............................ 07/10/2024 Polychlorinated (S) Waste plastics,
Dibenzodioxins and pyrolyzed, C5-55 fraction.
Polychlorinated
dibenzofurans Testing.
P-18-0124............................ 07/08/2024 90-Day Inhalation Toxicity (S) Lithium nickel potassium
(OECD Test Guideline 413). oxide.
P-21-0202, P-23-0104................. 07/23/2024 Determination of Dissociation (G) Sulfonium, carbomonocycle
Constant (Conductometric bis[(trihaloalkyl)carbomonoc
Method; OECD Guideline 112 ycle], substituted
OPPTS 830.7370). carbomonocyclic ester; (G)
Sulfonium, carbomonocycle
bis[(trihaloalkyl)carbomonoc
ycle], disubstituted
carbomonocyclic ester.
P-24-0154............................ 07/12/2024 Melting Point/Melting Range (G) Polyphenyl, ethoxy-
(OECD Test Guideline 102); polyfluoro-alkyl-.
Boiling Point/Boiling Range
(OECD Test Guideline 103);
Storage Stability (OECD Test
Guideline 113); Combined
Repeated Dose Toxicity with
the Reproduction/Development
Toxicity Screening Test
(OECD Test Guideline 422);
Particle Size, Fiber Length,
Diameter Distribution (OECD
Test Guideline 110); Density/
Relative Density/Bulk
Density (OECD Test Guideline
109); In Vitro Skin
Irritation Testing; Primary
Skin Irritation Testing in
Rabbits.
P-24-0154............................ 07/12/2024 Acute Oral Toxicity (OECD (G) Polyphenyl, ethoxy-
Test Guideline 423); Acute polyfluoro-alkyl-.
Eye Irritation (OECD Test
Guideline 405); Bovine
Corneal Opacity and
Permeability Test Method for
Identifying i) Chemicals
Inducing Serious Eye Damage
and ii) Chemicals Not
Requiring Classification for
Eye Irritation or Serious
Eye Damage (OECD Test
Guideline 437); In Vitro
Mammalian Chromosome
Aberration Test (OECD Test
Guideline 473); Skin
Sensitization (OECD Test
Guideline 429); Flammability
Testing; Bacterial Reverse
Mutation Test (OECD Test
Guideline 471).
----------------------------------------------------------------------------------------------------------------
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: August 22, 2024.
Pamela Myrick,
Director, Project Management and Operations Division, Office of
Pollution Prevention and Toxics.
[FR Doc. 2024-19304 Filed 8-27-24; 8:45 am]
BILLING CODE 6560-50-P