Notice2023-13165
Certain New Chemicals; Receipt and Status Information for May 2023
Primary source
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Published
June 21, 2023
Issuing agencies
Environmental Protection Agency
Abstract
EPA is required under the Toxic Substances Control Act (TSCA), as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act, to make information publicly available and to publish information in the Federal Register pertaining to submissions under TSCA section 5, including notice of receipt of a Premanufacture notice (PMN), Significant New Use Notice (SNUN) or Microbial Commercial Activity Notice (MCAN), including an amended notice or test information; an exemption application (Biotech exemption); an application for a test marketing exemption (TME), both pending and/or concluded; a notice of commencement (NOC) of manufacture (including import) for new chemical substances; and a periodic status report on new chemical substances that are currently under EPA review or have recently concluded review. This document covers the period from 5/1/ 2023 to 5/31/2023.
Full Text
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<title>Federal Register, Volume 88 Issue 118 (Wednesday, June 21, 2023)</title>
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[Federal Register Volume 88, Number 118 (Wednesday, June 21, 2023)]
[Notices]
[Pages 40257-40261]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Follow the online instructions
for submitting comments. Do not submit electronically any information
you consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Additional
instructions on commenting and visiting the docket, along with more
information about dockets generally, is available at <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
FOR FURTHER INFORMATION CONTACT: For technical information contact: Jim
Rahai, Project Management and Operations Division (MC 7407M), Office of
Pollution Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number:
(202) 564-8593; email address: <a href="/cdn-cgi/l/email-protection#c6b4a7aea7afe8acafab86a3b6a7e8a1a9b0"><span class="__cf_email__" data-cfemail="82f0e3eae3ebace8ebefc2e7f2e3ace5edf4">[email protected]</span></a>.
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: <a href="/cdn-cgi/l/email-protection#03575040422e4b6c776f6a6d66436673622d646c75"><span class="__cf_email__" data-cfemail="fda9aebebcd0b5928991949398bd988d9cd39a928b">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Executive Summary
A. What action is the Agency taking?
This document provides the receipt and status reports for the
period from 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: <a href="https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/status-pre-manufacture-notices">https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/status-pre-manufacture-notices</a>. This information is updated on a weekly basis.
B. What is the Agency's authority for taking this action?
Under the TSCA, 15 U.S.C. 2601 et seq., a chemical substance may be
either an ``existing'' chemical substance or a ``new'' chemical
substance. Any chemical substance that is not on EPA's TSCA Inventory
of Chemical Substances (TSCA Inventory) is classified as a ``new
chemical substance,'' while a chemical substance that is listed on the
TSCA Inventory is classified as an ``existing chemical substance.''
(See TSCA section 3(11).) For more information about the TSCA Inventory
please go to: <a href="https://www.epa.gov/tsca-inventory">https://www.epa.gov/tsca-inventory</a>.
Any person who intends to manufacture (including import) a new
chemical substance for a non-exempt commercial purpose, or to
manufacture or process a chemical substance in a non-exempt manner for
a use that EPA has determined is a significant new use, is required by
TSCA section 5 to provide EPA with a PMN, MCAN, or SNUN, as
appropriate, before initiating the activity. EPA will review the
notice, make a risk determination on the chemical substance or
significant new use, and take appropriate action as described in TSCA
section 5(a)(3).
TSCA section 5(h)(1) authorizes EPA to allow persons, upon
application and under appropriate restrictions, to manufacture or
process a new chemical substance, or a chemical substance subject to a
significant new use rule (SNUR) issued under TSCA section 5(a)(2), for
``test marketing'' purposes, upon a showing that the manufacture,
processing, distribution in commerce, use, and disposal of the chemical
will not present an unreasonable risk of injury to health or the
environment. This is referred to as a test marketing exemption, or TME.
For more information about the requirements applicable to a new
chemical go to: <a href="https://www.epa.gov/chemicals-under-tsca">https://www.epa.gov/chemicals-under-tsca</a>.
Under TSCA sections 5 and 8 and EPA regulations, EPA is required to
publish in the Federal Register certain information, including notice
of receipt of a PMN/SNUN/MCAN (including amended notices and test
information); an exemption application under 40 CFR part 725 (biotech
exemption); an application for a TME, both pending and concluded; NOCs
to manufacture a new chemical substance; and a periodic status report
on the new chemical substances that are currently under EPA review or
have recently concluded review.
C. Does this action apply to me?
This action provides information that is directed to the public in
general.
D. Does this action have any incremental economic impacts or paperwork
burdens?
No.
E. What should I consider as I prepare my comments for EPA?
1. Submitting confidential business information (CBI). Do not
submit this information to EPA through <a href="http://regulations.gov">regulations.gov</a> or email.
Clearly mark the part or all of the information that you claim to be
CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark
the outside of the disk or CD-ROM as CBI and then identify
electronically within the disk or CD-ROM the specific information that
is claimed as CBI. In addition to one complete version of the comment
that includes information claimed as CBI, a copy of the comment that
does not contain the information claimed as CBI must be submitted for
inclusion in the public docket. Information so marked will not be
disclosed except in accordance with procedures set forth in 40 CFR part
2.
2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at <a href="https://www.epa.gov/dockets/commenting-epa-dockets">https://www.epa.gov/dockets/commenting-epa-dockets</a>.
II. Status Reports
In the past, EPA has published individual notices reflecting the
status of TSCA section 5 filings received, pending, or concluded. In
1995, the Agency modified its approach and streamlined the information
published in the Federal Register after providing notice of such
changes to the public and an opportunity to comment (see the Federal
Register of May 12, 1995 (60 FR 25798) (FRL-4942-7)). Since the passage
of the Lautenberg amendments to TSCA in 2016, public interest in
information on the status of section 5 cases under EPA review and, in
particular, the final determination of such cases, has increased. In an
effort to be responsive to the regulated community, the users of this
information, and the general public, to comply with the requirements of
TSCA, to conserve EPA resources and to streamline the process and make
it more timely, EPA is providing information on its website about cases
reviewed under the amended TSCA, including the section 5 PMN/SNUN/MCAN
and exemption notices received, the date of receipt, the final EPA
determination on the notice, and the effective date of EPA's
determination for PMN/SNUN/MCAN notices on its website at: <a href="https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/status-pre-manufacture-notices">https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/status-pre-manufacture-notices</a>. This information is updated on a
weekly basis.
III. Receipt Reports
For the PMN/SNUN/MCANs that have passed an initial screening by EPA
during this period, Table I provides the following information (to the
extent that such information is not subject to a CBI claim) on the
notices screened by EPA 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]-.
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In Table II of this unit, EPA provides the following information
(to the extent that such information is not claimed as CBI) on the NOCs
that have passed an initial screening by EPA during this period: The
EPA case number assigned to the NOC including whether the submission
was an initial or amended submission, the date the NOC was received by
EPA, the date of commencement provided by the submitter in the NOC, a
notation of the type of amendment (e.g., amendment to generic name,
specific name, technical contact information, etc.) and chemical
substance identity.
Table II--NOCs Approved * From 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
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