Certain New Chemicals; Receipt and Status Information for May 2023, 40257-40261 [2023-13165]
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Federal Register / Vol. 88, No. 118 / Wednesday, June 21, 2023 / Notices
hours of operation, and special
arrangements should be made for
deliveries of boxed information.
Instructions: The EPA’s policy is that
all comments received will be included
in the public docket without change and
may be made available online at
www.regulations.gov including any
personal information provided unless
the comment includes information
claimed to be Confidential Business
Information (CBI) or other information
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know your identity or contact
information unless you provide it in the
body of your comment. If you send an
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without going through
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will be automatically captured and
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recommends that you include your
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EPA Docket Center homepage at https://
www.epa.gov/dockets/.
FOR FURTHER INFORMATION CONTACT: The
Designated Federal Officer (DFO), Tom
Tracy, via phone/voicemail at: 919–
541–4334; or via email at: tracy.tom@
epa.gov.
SUPPLEMENTARY INFORMATION:
General Information: The meeting is
open to the public. Any member of the
public interested in receiving a draft
agenda, attending the meeting, or
making a presentation at the meeting
may contact Tom Tracy, the Designated
Federal (DFO), via any of the contact
methods listed in the FOR FURTHER
INFORMATION CONTACT section above.
Individuals making an oral presentation
will be limited to a total of three
minutes.
For security purposes, all attendees
must provide their names to the DFO by
registering online at https://EPA-VOI_
July_meeting.eventbrite.com by July 21,
2023, and must go through a metal
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detector, sign in with the security desk,
and show REAL ID Act-compliant
government-issued photo identification
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encouraged to arrive at least 15 minutes
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enough time for security screening.
Proposed agenda items for the meeting
include but are not limited to the
following: Review of charge questions,
overview of the report outlining the case
study that uses VOI analysis to weigh
the public health and economic tradeoffs associated with the timeliness,
uncertainty, and costs of the draft EPA
Transcriptomic Assessment Product
(ETAP), and subcommittee
deliberations.
Information on Services for
Individuals with Disabilities: For
information on access or services for
individuals with disabilities, please
contact Tom Tracy (202) 564–6518 or
tracy.tom@epa.gov. To request
accommodation of a disability, please
contact Tom Tracy, preferably at least
ten days prior to the meeting, to give the
EPA as much time as possible to process
your request.
Mary Ross,
Director, Office of Science Advisor, Policy,
and Engagement.
[FR Doc. 2023–13188 Filed 6–20–23; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–OPPT–2023–0061; FRL–10581–
05–OCSPP]
Certain New Chemicals; Receipt and
Status Information for May 2023
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;
SUMMARY:
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40257
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 5/1/2023 to 5/31/
2023.
DATES: Comments identified by the
specific case number provided in this
document must be received on or before
July 21, 2023.
ADDRESSES: Submit your comments,
identified by docket identification (ID)
number EPA–HQ–OPPT–2023–0061,
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: rahai.jim@
epa.gov.
For general information contact: The
TSCA-Hotline, ABVI-Goodwill, 422
South Clinton Ave., Rochester, NY
14620; telephone number: (202) 554–
1404; email address: TSCA-Hotline@
epa.gov.
SUPPLEMENTARY INFORMATION:
I. Executive Summary
A. What action is the Agency taking?
This document provides the receipt
and status reports for the period from 5/
01/2023 to 5/31/2023. 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/
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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 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-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
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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
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
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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’’ (i.e., 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.
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Federal Register / Vol. 88, No. 118 / Wednesday, June 21, 2023 / Notices
40259
TABLE I—PMN/SNUN/MCANS APPROVED * FROM 05/01/2023 TO 05/31/2023
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Case No.
Version
Received
date
Manufacturer
Use
Chemical substance
(G) Metal, [heteropolycyclic]-,
[[[(hydroxyalkyl)amino]sulfonyl]alkyl]
sulfonyl(sulfoalkyl)sulfonyl derivs.,
ammonium sodium salts.
(G) Sodium bis(chloropropanediol)
phosphate.
(S) Ethanol, 2-amino-, compds. with
polyethylene glycol hydrogen sulfate
C10–16-alkyl ether.
(G) Oxirane, 2-methyl-, polymer with
oxirane, mono-isoalkyl ethers,
phosphates, salt.
(G) Glycolipids, sophorose-contg.,
yeast-fermented, from glycerides
and carbohydrates.
(G) Glycolipids, sophorose-contg.,
yeast-fermented, from glycerides
and carbohydrates.
(G) Glycolipids, sophorose-contg.,
yeast-fermented, from glycerides
and carbohydrates.
(G) Glycolipids, sophorose-contg.,
yeast-fermented, from glycerides
and carbohydrates.
(G) Glycolipids, sophorose-contg.,
yeast-fermented, from glycerides
and carbohydrates.
(G) Glycolipids, sophorose-contg.,
yeast-fermented, from glycerides
and carbohydrates.
(S) Maltodextrin, octanoate.
P–21–0168A
4
05/10/2023
CBI ........................
(G) Colorant .........................................
P–22–0014A
5
05/03/2023
(G) Precursor .......................................
P–22–0053A
4
05/11/2023
Colonial Chemical,
Inc.
CBI ........................
P–22–0078A
5
05/09/2023
CBI ........................
(S) Dispersing agent for pesticide formulators.
P–22–0095A
4
05/05/2023
Locus Fermentation Solutions.
(G) Surfactant for commercial, industrial, consumer applications.
P–22–0096A
4
05/05/2023
Locus Fermentation Solutions.
(G) Surfactant for commercial, industrial, consumer applications.
P–22–0097A
4
05/05/2023
Locus Fermentation Solutions.
(G) Surfactant for commercial, industrial, consumer applications.
P–22–0098A
4
05/05/2023
Locus Fermentation Solutions.
(G) Surfactant for commercial, industrial, consumer applications.
P–22–0099A
4
05/05/2023
Locus Fermentation Solutions.
(G) Surfactant for commercial, industrial, consumer applications.
P–22–0100A
4
05/05/2023
Locus Fermentation Solutions.
(G) Surfactant for commercial, industrial, consumer applications.
P–22–0130A
4
05/17/2023
Integrity Bio-chemical, LLC.
P–22–0131A
4
05/17/2023
Integrity Bio-chemical, LLC.
P–22–0132A
4
05/17/2023
Integrity Bio-chemical, LLC.
(S) Surfactant—surface tension reducing agent for use in production enhancement in oil wells (industrial),
emulsifier, surface reduction household and industrial detergents, emulsifier, wetting agent personal care,
cosmetic, and pet care grooming
products, wetting agent—agriculture,
surfactants—as raw materials for
use in the manufacture of industrial
products and consumer and household products.
(S) Surfactant—surface tension reducing agent for use in production enhancement in oil wells (industrial),
emulsifier, surface reduction household and industrial detergents, emulsifier, wetting agent personal care,
cosmetic, and pet care grooming
products, wetting agent—agriculture,
surfactants—as raw materials for
use in the manufacture of industrial
products and consumer and household products.
(S) Surfactant—surface tension reducing agent for use in production enhancement in oil wells (industrial),
emulsifier, surface reduction household and industrial detergents, emulsifier, wetting agent personal care,
cosmetic, and pet care grooming
products, wetting agent—agriculture,
surfactants—as raw materials for
use in the manufacture of industrial
products and consumer and household products.
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(G) Additive in agricultural formulations
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(S) Maltodextrin, hexadecanoate.
(S) Maltodextrin, decanoate.
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TABLE I—PMN/SNUN/MCANS APPROVED * FROM 05/01/2023 TO 05/31/2023—Continued
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Case No.
Version
Received
date
Manufacturer
Use
(S) Surfactant—surface tension reducing agent for use in production enhancement in oil wells (industrial),
emulsifier, surface reduction household and industrial detergents, emulsifier, wetting agent personal care,
cosmetic, and pet care grooming
products, wetting agent—agriculture,
surfactants—as raw materials for
use in the manufacture of industrial
products and consumer and household products.
(S) Surfactant—surface tension reducing agent for use in production enhancement in oil wells (industrial),
emulsifier, surface reduction household and industrial detergents, emulsifier, wetting agent personal care,
cosmetic, and pet care grooming
products, wetting agent—agriculture,
surfactants—as raw materials for
use in the manufacture of industrial
products and consumer and household products.
(S) Surfactant—surface tension reducing agent for use in production enhancement in oil wells (industrial),
emulsifier, surface reduction, household and industrial detergents, emulsifier, wetting agent personal care,
cosmetic, and pet care grooming
products, wetting agent—agriculture,
surfactants—as raw materials for
use in the manufacture of industrial
products and consumer and household products.
(G) Surfactant for commercial applications.
P–22–0133A
4
05/17/2023
Integrity Bio-chemical, LLC.
P–22–0134A
4
05/17/2023
Integrity Bio-chemical, LLC.
P–22–0135A
4
05/17/2023
Integrity Bio-chemical, LLC.
P–22–0151A
5
05/08/2023
CBI ........................
P–23–0070A
3
05/04/2023
CBI ........................
P–23–0079 ...
4
05/09/2023
Lawter ...................
P–23–0105A
3
05/02/2023
P–23–0118 ...
3
04/27/2023
Heebut Materials,
LLC.
CBI ........................
P–23–0127 ...
2
05/18/2023
CBI ........................
P–23–0128 ...
2
05/17/2023
CBI ........................
P–23–0129 ...
3
05/16/2023
Polymer Additives,
Inc.
P–23–0133 ...
1
05/08/2023
CBI ........................
(G) Used as an intermediate and will
be consumed internally by Valtris to
make the end product which is intended to market to customers.
(G) Component in asphalt ....................
P–23–0135 ...
P–23–0136 ...
1
1
05/12/2023
05/17/2023
CBI ........................
CBI ........................
(G) Destructive use ..............................
(G) Component in asphalt ....................
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(G) Surfactant for cleaning products,
pet shampoo, hand cleansing, laundry, and dishwasher detergent.
(G) Non-reactive resin to improve ink
performance Establishes a good
flow and disperse pigment and has
lithographic properties.
(G) Plastic and rubber additive ............
(G) Reactant .........................................
(S) Ingredient in laundry detergent that
is used for degradation of stains on
fabric.
(G) Textile softening applications ........
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Chemical substance
(S) Maltodextrin, octadecanoate.
(S) Maltodextrin, dodecanoate.
(S) Maltodextrin, tetradecanoate.
(G) Glycolipids, sophorose-contg.,
yeast-fermented, from glycerides
and carbohydrates.
(S) Fatty Acids, C8–14, methyl-2sulfoethyl esters, sodium salts.
(S) rosin, maleated, polymer with benzoic acid, glycerol, propylene glycol
and 3a,4,7,7a-tetrahydro-1,3isobenzofurandione.
(G) Multi-Walled Carbon Nanotube.
(G) Glycerides from fermentation of
genetically modified microorganism,
ethoxylated, reaction products with
ethanol, polycyclic isocyanate.
(G) Polysaccharide Lyase.
(S) Fatty acids, C16–18, reaction products with diethanolamine.
(G) Soy or rapeseed fatty acid, benzyl
esters.
(G) Fatty acids reaction products with
alcoholamine reaction by-products,
salts.
(G) Alken-1-ol, 1-acetate.
(G) Fatty acids, reaction products with
hexamethylenediamine and 12hydroxyoctadecanoic acid.
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TABLE I—PMN/SNUN/MCANS APPROVED * FROM 05/01/2023 TO 05/31/2023—Continued
Case No.
Version
Received
date
Manufacturer
Use
Chemical substance
P–23–0140 ...
2
05/23/2023
CBI ........................
(G) Additive for consumer and commercial products.
P–23–0141 ...
1
05/23/2023
Hach Company .....
SN–16–0013A
5
05/08/2023
CBI ........................
(G) Buffer solution for free chlorine determination.
(G) Surfactant .......................................
SN–20–0003A
10
05/08/2023
CBI ........................
SN–21–0011A
3
05/11/2023
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
(G) Polysaccharide,
(hydroxytrialkylammonio)alkyl ether,
chloride.
(S) 2-Butenedioic acid (2Z)-, potassium salt (1:?).
(G) Polyfluorinated alkyl quaternary
ammonium chloride.
(S) 1-Propanesulfonic acid, 2-methyl-2[[1-oxo-3-[(3,3,4,4,5,5,6,6,7,7,8,8,8tridecafluorooctyl)thio]propyl]amino]-,
sodium salt (1:1).
(S) An anionic fluorosurfactant used in
firefighting foam concentrates such
as AFFF (Aqueous Film Forming
Foam) and AR–AFFF (Alcohol Resistant Aqueous Fim Forming Foam).
(G) Solvent ........................................... (S) 2-Propanol, 1-[bis(2-hydroxyethyl)amino]-.
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 05/01/2023 TO 05/31/2023
Case No.
P–19–0185 ..
P–95–0224 ..
Received date
Commencement
date
If amendment,
type of
amendment
05/11/2023
05/16/2023
04/03/2023
04/28/1995
N
N
Chemical substance
(S) Benzoic acid, 2-chloro-3-methyl-, sodium salt (1:1).
(S) 2-propenoic acid,2-methyl-,2-(dimethylamino)ethyl ester, polymer with
1-ethenylhexahydro-2h-azepin-2-one & vinylpyrrolidone.
* 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 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 05/01/2023 TO 05/31/2023
Case No.
P–23–0124 ..
Received date
05/24/2023
Type of test information
Acute Oral Toxicity/Pathogenicity (OCSPP Test Guideline 885.3050); Bacterial Reverse Mutation Test
(OECD Test Guideline 471).
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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: June 14, 2023.
Pamela Myrick,
Director, Project Management and Operations
Division, Office of Pollution Prevention and
Toxics.
[FR Doc. 2023–13165 Filed 6–20–23; 8:45 am]
BILLING CODE 6560–50–P
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Chemical substance
Jkt 259001
(G) Sulfonium, tricabocyclic-, 2-heteroatom-substituted-(halocarbocyclic)carboxylate (1:1).
ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–ORD–2015–0765; FRL–10949–01–
ORD]
EPA Transcriptomic Assessment
Product (ETAP) Panel Under the Board
of Scientific Counselors (BOSC)—July
2023
Environmental Protection
Agency (EPA).
ACTION: Notice of public meeting.
AGENCY:
The U.S. Environmental
Protection Agency (EPA) has selected
SUMMARY:
PO 00000
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technical experts to serve as Special
Government Employees (SGEs) on a
review panel under the authority of the
Board of Scientific Counselors (BOSC),
a federal advisory committee to the
Office of Research and Development
(ORD). Selected experts will review
ORD’s draft documents detailing
scientific studies supporting the
development of transcriptomic-based
reference values and their
implementation as a new EPA
Transcriptomic Assessment Product
(ETAP). The ETAP is a proposed ORD
assessment product that utilizes a
standardized short-term in vivo study
E:\FR\FM\21JNN1.SGM
21JNN1
]]>Agencies
[Federal Register Volume 88, Number 118 (Wednesday, June 21, 2023)]
[Notices]
[Pages 40257-40261]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-13165]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2023-0061; FRL-10581-05-OCSPP]
Certain New Chemicals; Receipt and Status Information for May
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 5/1/
2023 to 5/31/2023.
DATES: Comments identified by the specific case number provided in this
document must be received on or before July 21, 2023.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2023-0061, 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 5/01/2023 to 5/31/2023. 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/
[[Page 40258]]
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 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 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'' (i.e., 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.
[[Page 40259]]
Table I--PMN/SNUN/MCANs Approved * From 05/01/2023 to 05/31/2023
----------------------------------------------------------------------------------------------------------------
Received
Case No. Version date Manufacturer Use Chemical substance
----------------------------------------------------------------------------------------------------------------
P-21-0168A......... 4 05/10/2023 CBI............... (G) Colorant........... (G) Metal,
[heteropolycyclic]-,
[[[(hydroxyalkyl)amino
]sulfonyl]alkyl]sulfon
yl(sulfoalkyl)sulfonyl
derivs., ammonium
sodium salts.
P-22-0014A......... 5 05/03/2023 Colonial Chemical, (G) Precursor.......... (G) Sodium
Inc. bis(chloropropanediol)
phosphate.
P-22-0053A......... 4 05/11/2023 CBI............... (G) Additive in (S) Ethanol, 2-amino-,
agricultural compds. with
formulations. polyethylene glycol
hydrogen sulfate C10-
16-alkyl ether.
P-22-0078A......... 5 05/09/2023 CBI............... (S) Dispersing agent (G) Oxirane, 2-methyl-,
for pesticide polymer with oxirane,
formulators. mono-isoalkyl ethers,
phosphates, salt.
P-22-0095A......... 4 05/05/2023 Locus Fermentation (G) Surfactant for (G) Glycolipids,
Solutions. commercial, sophorose-contg.,
industrial, consumer yeast-fermented, from
applications. glycerides and
carbohydrates.
P-22-0096A......... 4 05/05/2023 Locus Fermentation (G) Surfactant for (G) Glycolipids,
Solutions. commercial, sophorose-contg.,
industrial, consumer yeast-fermented, from
applications. glycerides and
carbohydrates.
P-22-0097A......... 4 05/05/2023 Locus Fermentation (G) Surfactant for (G) Glycolipids,
Solutions. commercial, sophorose-contg.,
industrial, consumer yeast-fermented, from
applications. glycerides and
carbohydrates.
P-22-0098A......... 4 05/05/2023 Locus Fermentation (G) Surfactant for (G) Glycolipids,
Solutions. commercial, sophorose-contg.,
industrial, consumer yeast-fermented, from
applications. glycerides and
carbohydrates.
P-22-0099A......... 4 05/05/2023 Locus Fermentation (G) Surfactant for (G) Glycolipids,
Solutions. commercial, sophorose-contg.,
industrial, consumer yeast-fermented, from
applications. glycerides and
carbohydrates.
P-22-0100A......... 4 05/05/2023 Locus Fermentation (G) Surfactant for (G) Glycolipids,
Solutions. commercial, sophorose-contg.,
industrial, consumer yeast-fermented, from
applications. glycerides and
carbohydrates.
P-22-0130A......... 4 05/17/2023 Integrity Bio- (S) Surfactant--surface (S) Maltodextrin,
chemical, LLC. tension reducing agent octanoate.
for use in production
enhancement in oil
wells (industrial),
emulsifier, surface
reduction household
and industrial
detergents,
emulsifier, wetting
agent personal care,
cosmetic, and pet care
grooming products,
wetting agent--
agriculture,
surfactants--as raw
materials for use in
the manufacture of
industrial products
and consumer and
household products.
P-22-0131A......... 4 05/17/2023 Integrity Bio- (S) Surfactant--surface (S) Maltodextrin,
chemical, LLC. tension reducing agent hexadecanoate.
for use in production
enhancement in oil
wells (industrial),
emulsifier, surface
reduction household
and industrial
detergents,
emulsifier, wetting
agent personal care,
cosmetic, and pet care
grooming products,
wetting agent--
agriculture,
surfactants--as raw
materials for use in
the manufacture of
industrial products
and consumer and
household products.
P-22-0132A......... 4 05/17/2023 Integrity Bio- (S) Surfactant--surface (S) Maltodextrin,
chemical, LLC. tension reducing agent decanoate.
for use in production
enhancement in oil
wells (industrial),
emulsifier, surface
reduction household
and industrial
detergents,
emulsifier, wetting
agent personal care,
cosmetic, and pet care
grooming products,
wetting agent--
agriculture,
surfactants--as raw
materials for use in
the manufacture of
industrial products
and consumer and
household products.
[[Page 40260]]
P-22-0133A......... 4 05/17/2023 Integrity Bio- (S) Surfactant--surface (S) Maltodextrin,
chemical, LLC. tension reducing agent octadecanoate.
for use in production
enhancement in oil
wells (industrial),
emulsifier, surface
reduction household
and industrial
detergents,
emulsifier, wetting
agent personal care,
cosmetic, and pet care
grooming products,
wetting agent--
agriculture,
surfactants--as raw
materials for use in
the manufacture of
industrial products
and consumer and
household products.
P-22-0134A......... 4 05/17/2023 Integrity Bio- (S) Surfactant--surface (S) Maltodextrin,
chemical, LLC. tension reducing agent dodecanoate.
for use in production
enhancement in oil
wells (industrial),
emulsifier, surface
reduction household
and industrial
detergents,
emulsifier, wetting
agent personal care,
cosmetic, and pet care
grooming products,
wetting agent--
agriculture,
surfactants--as raw
materials for use in
the manufacture of
industrial products
and consumer and
household products.
P-22-0135A......... 4 05/17/2023 Integrity Bio- (S) Surfactant--surface (S) Maltodextrin,
chemical, LLC. tension reducing agent tetradecanoate.
for use in production
enhancement in oil
wells (industrial),
emulsifier, surface
reduction, household
and industrial
detergents,
emulsifier, wetting
agent personal care,
cosmetic, and pet care
grooming products,
wetting agent--
agriculture,
surfactants--as raw
materials for use in
the manufacture of
industrial products
and consumer and
household products.
P-22-0151A......... 5 05/08/2023 CBI............... (G) Surfactant for (G) Glycolipids,
commercial sophorose-contg.,
applications. yeast-fermented, from
glycerides and
carbohydrates.
P-23-0070A......... 3 05/04/2023 CBI............... (G) Surfactant for (S) Fatty Acids, C8-14,
cleaning products, pet methyl-2-sulfoethyl
shampoo, hand esters, sodium salts.
cleansing, laundry,
and dishwasher
detergent.
P-23-0079.......... 4 05/09/2023 Lawter............ (G) Non-reactive resin (S) rosin, maleated,
to improve ink polymer with benzoic
performance acid, glycerol,
Establishes a good propylene glycol and
flow and disperse 3a,4,7,7a-tetrahydro-
pigment and has 1,3-
lithographic isobenzofurandione.
properties.
P-23-0105A......... 3 05/02/2023 Heebut Materials, (G) Plastic and rubber (G) Multi-Walled Carbon
LLC. additive. Nanotube.
P-23-0118.......... 3 04/27/2023 CBI............... (G) Reactant........... (G) Glycerides from
fermentation of
genetically modified
microorganism,
ethoxylated, reaction
products with ethanol,
polycyclic isocyanate.
P-23-0127.......... 2 05/18/2023 CBI............... (S) Ingredient in (G) Polysaccharide
laundry detergent that Lyase.
is used for
degradation of stains
on fabric.
P-23-0128.......... 2 05/17/2023 CBI............... (G) Textile softening (S) Fatty acids, C16-
applications. 18, reaction products
with diethanolamine.
P-23-0129.......... 3 05/16/2023 Polymer Additives, (G) Used as an (G) Soy or rapeseed
Inc. intermediate and will fatty acid, benzyl
be consumed internally esters.
by Valtris to make the
end product which is
intended to market to
customers.
P-23-0133.......... 1 05/08/2023 CBI............... (G) Component in (G) Fatty acids
asphalt. reaction products with
alcoholamine reaction
by-products, salts.
P-23-0135.......... 1 05/12/2023 CBI............... (G) Destructive use.... (G) Alken-1-ol, 1-
acetate.
P-23-0136.......... 1 05/17/2023 CBI............... (G) Component in (G) Fatty acids,
asphalt. reaction products with
hexamethylenediamine
and 12-
hydroxyoctadecanoic
acid.
[[Page 40261]]
P-23-0140.......... 2 05/23/2023 CBI............... (G) Additive for (G) Polysaccharide,
consumer and (hydroxytrialkylammoni
commercial products. o)alkyl ether,
chloride.
P-23-0141.......... 1 05/23/2023 Hach Company...... (G) Buffer solution for (S) 2-Butenedioic acid
free chlorine (2Z)-, potassium salt
determination. (1:?).
SN-16-0013A........ 5 05/08/2023 CBI............... (G) Surfactant......... (G) Polyfluorinated
alkyl quaternary
ammonium chloride.
SN-20-0003A........ 10 05/08/2023 CBI............... (S) An anionic (S) 1-Propanesulfonic
fluorosurfactant used acid, 2-methyl-2-[[1-
in firefighting foam oxo-3-
concentrates such as [(3,3,4,4,5,5,6,6,7,7,
AFFF (Aqueous Film 8,8,8-
Forming Foam) and AR- tridecafluorooctyl)thi
AFFF (Alcohol o]propyl]amino]-,
Resistant Aqueous Fim sodium salt (1:1).
Forming Foam).
SN-21-0011A........ 3 05/11/2023 CBI............... (G) Solvent............ (S) 2-Propanol, 1-
[bis(2-
hydroxyethyl)amino]-.
----------------------------------------------------------------------------------------------------------------
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 05/01/2023 to 05/31/2023
----------------------------------------------------------------------------------------------------------------
If amendment,
Case No. Received date Commencement type of Chemical substance
date amendment
----------------------------------------------------------------------------------------------------------------
P-19-0185................... 05/11/2023 04/03/2023 N (S) Benzoic acid, 2-chloro-3-
methyl-, sodium salt (1:1).
P-95-0224................... 05/16/2023 04/28/1995 N (S) 2-propenoic acid,2-methyl-,2-
(dimethylamino)ethyl ester,
polymer with 1-ethenylhexahydro-
2h-azepin-2-one &
vinylpyrrolidone.
----------------------------------------------------------------------------------------------------------------
* 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 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 05/01/2023 to 05/31/2023
----------------------------------------------------------------------------------------------------------------
Case No. Received date Type of test information Chemical substance
----------------------------------------------------------------------------------------------------------------
P-23-0124................... 05/24/2023 Acute Oral Toxicity/ (G) Sulfonium, tricabocyclic-, 2-
Pathogenicity (OCSPP Test heteroatom-substituted-
Guideline 885.3050); Bacterial (halocarbocyclic)carboxylate
Reverse Mutation Test (OECD (1:1).
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: June 14, 2023.
Pamela Myrick,
Director, Project Management and Operations Division, Office of
Pollution Prevention and Toxics.
[FR Doc. 2023-13165 Filed 6-20-23; 8:45 am]
BILLING CODE 6560-50-P
