Certain New Chemicals; Receipt and Status Information for January 2023
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Issuing agencies
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 1/1/ 2023 to 1/31/2023.
Full Text
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<title>Federal Register, Volume 88 Issue 33 (Friday, February 17, 2023)</title>
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[Federal Register Volume 88, Number 33 (Friday, February 17, 2023)]
[Notices]
[Pages 10320-10325]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-03362]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2023-0061; FRL-10581-01-OCSPP]
Certain New Chemicals; Receipt and Status Information for January
2023
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: EPA is required under the Toxic Substances Control Act (TSCA),
[[Page 10321]]
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 1/1/
2023 to 1/31/2023.
DATES: Comments identified by the specific case number provided in this
document must be received on or before March 20, 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#9deffcf5fcf4b3f7f4f0ddf8edfcb3faf2eb"><span class="__cf_email__" data-cfemail="4032212821296e2a292d002530216e272f36">[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#b7e3e4f4f69affd8c3dbded9d2f7d2c7d699d0d8c1"><span class="__cf_email__" data-cfemail="f8acabbbb9d5b0978c9491969db89d8899d69f978e">[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 1/01/2023 to 1/31/2023. The Agency is providing notice of
receipt of PMNs, SNUNs, and MCANs (including amended notices and test
information); an exemption application under 40 CFR part 725 (Biotech
exemption); TMEs, both pending and/or concluded; NOCs to manufacture a
new chemical substance; and a periodic status report on new chemical
substances that are currently under EPA review or have recently
concluded review.
EPA is also providing information on its website about cases
reviewed under the amended TSCA, including the section 5 PMN/SNUN/MCAN
and exemption notices received, the date of receipt, the final EPA
determination on the notice, and the effective date of EPA's
determination for PMN/SNUN/MCAN notices on its website at: <a href="https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/status-pre-manufacture-notices">https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/status-pre-manufacture-notices</a>. This information is updated on a
weekly basis.
B. What is the Agency's authority for taking this action?
Under the Toxic Substances Control Act (TSCA), 15 U.S.C. 2601 et
seq., a chemical substance may be either an ``existing'' chemical
substance or a ``new'' chemical substance. Any chemical substance that
is not on EPA's TSCA Inventory of Chemical Substances (TSCA Inventory)
is classified as a ``new chemical substance,'' while a chemical
substance that is listed on the TSCA Inventory is classified as an
``existing chemical substance.'' (See TSCA section 3(11).) For more
information about the TSCA Inventory please go to: <a href="https://www.epa.gov/tsca-inventory">https://www.epa.gov/tsca-inventory</a>.
Any person who intends to manufacture (including import) a new
chemical substance for a non-exempt commercial purpose, or to
manufacture or process a chemical substance in a non-exempt manner for
a use that EPA has determined is a significant new use, is required by
TSCA section 5 to provide EPA with a PMN, MCAN, or SNUN, as
appropriate, before initiating the activity. EPA will review the
notice, make a risk determination on the chemical substance or
significant new use, and take appropriate action as described in TSCA
section 5(a)(3).
TSCA section 5(h)(1) authorizes EPA to allow persons, upon
application and under appropriate restrictions, to manufacture or
process a new chemical substance, or a chemical substance subject to a
significant new use rule (SNUR) issued under TSCA section 5(a)(2), for
``test marketing'' purposes, upon a showing that the manufacture,
processing, distribution in commerce, use, and disposal of the chemical
will not present an unreasonable risk of injury to health or the
environment. This is referred to as a test marketing exemption, or TME.
For more information about the requirements applicable to a new
chemical go to: <a href="https://www.epa.gov/under-tsca">https://www.epa.gov/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
[[Page 10322]]
an opportunity to comment (see the Federal Register of May 12, 1995 (60
FR 25798) (FRL-4942-7)). Since the passage of the Lautenberg amendments
to TSCA in 2016, public interest in information on the status of
section 5 cases under EPA review and, in particular, the final
determination of such cases, has increased. In an effort to be
responsive to the regulated community, the users of this information,
and the general public, to comply with the requirements of TSCA, to
conserve EPA resources and to streamline the process and make it more
timely, EPA is providing information on its website about cases
reviewed under the amended TSCA, including the section 5 PMN/SNUN/MCAN
and exemption notices received, the date of receipt, the final EPA
determination on the notice, and the effective date of EPA's
determination for PMN/SNUN/MCAN notices on its website at: <a href="https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/status-pre-manufacture-notices">https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/status-pre-manufacture-notices</a>. This information is updated on a
weekly basis.
III. Receipt Reports
For the PMN/SNUN/MCANs that have passed an initial screening by EPA
during this period, Table I provides the following information (to the
extent that such information is not subject to a CBI claim) on the
notices screened by EPA during this period: The EPA case number
assigned to the notice that indicates whether the submission is an
initial submission, or an amendment, a notation of which version was
received, the date the notice was received by EPA, the submitting
manufacturer (i.e., domestic producer or importer), the potential uses
identified by the manufacturer in the notice, and the chemical
substance identity.
As used in each of the tables in this unit, (S) indicates that the
information in the table is the specific information provided by the
submitter, and (G) indicates that this information in the table is
generic information because the specific information provided by the
submitter was claimed as CBI. Submissions which are initial submissions
will not have a letter following the case number. Submissions which are
amendments to previous submissions will have a case number followed by
the letter ``A'' (e.g., P-18-1234A). The version column designates
submissions in sequence as ``1'', ``2'', ``3'', etc. Note that in some
cases, an initial submission is not numbered as version 1; this is
because earlier version(s) were rejected as incomplete or invalid
submissions. Note also that future versions of the following tables may
adjust slightly as the Agency works to automate population of the data
in the tables.
Table I--PMN/SNUN/MCANs Approved * From 01/01/2023 to 01/31/2023
--------------------------------------------------------------------------------------------------------------------------------------------------------
Case No. Version Received date Manufacturer Use Chemical substance
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J-23-0001............................. 7 12/30/2022 Lesaffre Yeast (G) Ethanol production... (G) Saccharomyces
Corporation. cerevisiae, modified to
express glucoamylase
activity.
J-23-0003............................. 1 12/08/2022 CBI...................... (G) Production of an (G) Microorganism
enzyme mixture. expressing enzymes.
J-23-0003A............................ 2 01/20/2023 CBI...................... (G) Production of an (G) Microorganism
enzyme mixture. expressing enzymes.
J-23-0003A............................ 3 01/30/2023 CBI...................... (G) Production of an (G) Microorganism
enzyme mixture. expressing enzymes.
P-18-0365A............................ 5 01/09/2023 CBI...................... (G) Superabsorbent (G) Starch, carboxymethyl
polymer, (S) Manufacture ether, sodium salt,
for export only. polymer with
polycarboxylic acid.
P-18-0366A............................ 5 01/09/2023 CBI...................... (G) Superabsorbent (G) Starch, carboxymethyl
polymer, (S) Manufacture ether, sodium salt,
for export only. polymer with mixed
polycarboxylic acids.
P-19-0095A............................ 7 12/22/2022 CBI...................... (G) Consumer Disposables, (G) Poly hydroxy
Polymer Sheet, Durable alkanoate.
Goods.
P-22-0009A............................ 4 01/25/2023 CBI...................... (S) Gasoline blending (S) Alkanes, C4-C9-
component to reduce the branched and linear.
average carbon intensity
and subsequent CO2
emissions of fuel.
P-22-0054A............................ 2 01/05/2023 CBI...................... (G) Additive for paint (G) Graphene
and coatings. nanoplatelets.
P-22-0068A............................ 3 01/24/2023 Aditya Birla Chemicals (S) An epoxy component (S) 2-Propanamine, 1,1'-
(USA), LLC. used in a reaction with [(1-
other components to methylethylidene)bis(oxy)
produce an epoxy article. ]bis-.
P-22-0182............................. 6 01/16/2023 Goulston Technologies.... (G) Textile wear additive (G) Poly(ethylene
terephthalate)-co-
poly(propyl trimethylol
alkanoate).
P-23-0014A............................ 6 01/05/2023 CBI...................... (G) Intermediate in (G) [Polyalkyl-
production of fragrance. methylenepolyhydro-
polycyclic]alkyl acetate.
P-23-0036A............................ 3 01/10/2023 Elantas PDG, Inc......... (S) MF8044 Resin is an (S) Castor oil, polymer
unsaturated polyester with dicyclopentadiene,
resin used in an maleic anhydride, 2-
electrical insulation methyl-1,3-propanediol,
coating. The coating is 3a,4,7,7a-tetrahydro-2-(2-
used to insulate hydroxyethyl)-1H-
electrical components in isoindole-1,3(2H)-dione
automobiles. and triethylene glycol.
P-23-0042A............................ 2 01/10/2023 Clariant Corporation..... (S) Intermediate for use (G) Oxirane, alkyl-,
in producing polymers. polymer with oxirane,
monoethers with
polyethylene glycol
alkenyl ether.
P-23-0045............................. 3 01/05/2023 Colonial Chemical, Inc... (S) Water based (G) Carboxylic acid,
metalworking fluids, compound with 2,2',2''-
Metal cleaners, Metal nitrilotris[ethanol]
treating fluids. (1:1);(G) Carboxylic
acid, compound with 2-
aminoethanol (1:1).
P-23-0045A............................ 4 01/20/2023 Colonial Chemical, Inc... (S) Water based (G) Carboxylic acid,
metalworking fluids, compound with 2,2',2''-
Metal cleaners, Metal nitrilotris[ethanol]
treating fluids. (1:1);(G) Carboxylic
acid, compound with 2-
aminoethanol (1:1).
[[Page 10323]]
P-23-0048A............................ 3 12/28/2022 Dynax Corporation........ (G) Additive used in (G) Alkenoic acid,
industrial and reaction products with
commercial applications. polyalkenimine, poly-
mercapto alkanolester and
C6-fluoro haloalkane,
compds. with
alkanolamine.
P-23-0061............................. 1 12/29/2022 CBI...................... (G) Plastic resin........ (G) Alkanoic acid,
substituted, polymer with
substituted alkanoic
acid, from fermentation
of fermentable sugars.
P-23-0061A............................ 2 01/30/2023 CBI...................... (G) Plastic resin........ (G) Alkanoic acid,
substituted, polymer with
substituted alkanoic
acid, from fermentation
of fermentable sugars.
P-23-0064............................. 1 01/09/2023 CBI...................... (G) Component in (G) Alkanediol,
aerospace coatings. substituted, polymer with
diisocyanatoalkane,
substituted heterocycle-
modified.
P-23-0065............................. 1 01/11/2023 Cytec Industries, Inc.... (G) Industrial process (G) Alkyl acid, 2-hydroxy-
chemical. , methyl substituted
alkyl ester.
P-23-0066............................. 1 01/17/2023 CBI...................... (G) An antioxidant (G) alkylated phenyl-
additive. naphthalene amine.
P-23-0068............................. 4 01/30/2023 US Polymers Accurez, LLC. (S) Ingredient in (S) 1,3-
industrial primers and Isobenzofurandione,
topcoats. hexahydro-, polymer with
1,4-
cyclohexanedimethanol,
isononanoate.
P-23-0071............................. 1 01/18/2023 Colonial Chemical, Inc... (S) Water based (G) alkyl dicarboxylic
metalworking fluids, acid, compound with
Metal cleaner. 2,2',2''-
nitrilotris[ethanol]
(1:?).
P-23-0073............................. 1 01/24/2023 Heraeus Epurio, LLC...... (S) Use as a photoacid (S) Methanesulfonic acid,
generator for 1,1,1-trifluoro-, 1,3-
photoresist applications. dioxo-1H-
benz[de]isoquinolin-2(3H)-
yl ester.
P-23-0074............................. 1 01/24/2023 BASF Corporation......... (S) Monomer used in the (S) 2-Propenoic acid, 2-
production of polymers. methyl-, C13-15-branched
and linear alkyl esters.
P-23-0075............................. 1 01/25/2023 Colonial Chemical, Inc... (S) Lubricant additive, (G) Amides, vegetable oil,
water based cutting hydroxylated amine,
fluids, institutional amides, soya,
cleaning products, and hydroxylated amine.
cleaning in place
applications (G)
Surfactant used in
personal care products.
P-23-0076............................. 1 01/26/2023 CBI...................... (G) Dyestuff............. (G) 1,5-Carbopolycycle
disulfonic acid, 2-[2-[8-
[[4-chloro-6-
(ethylcarbomonocyclic
amino)-
heteromonocyclic]amino]-1-
hydroxy-3,6-disulfo-2-
carbopolycyclic]diazenyl]-
, sodium salt (1:4).
SN-23-0002............................ 2 12/30/2022 CBI...................... (G) The LCPFACs have no (S) Octanoic acid,
function or application. 2,2,3,3,4,4,5,5,6,6,7,7,8
,8,8-pentadecafluoro-.
SN-23-0003............................ 2 12/30/2022 CBI...................... (G) The LCPFACs have no (S) Dodecanoic acid,
function or application. 2,2,3,3,4,4,5,5,6,6,7,7,8
,8,9,9,10,10,11,11,12,12,
12-tricosafluoro-.
SN-23-0004............................ 2 12/30/2022 CBI...................... (G) The LCPFACs have no (S) Nonanoic acid,
function or application. 2,2,3,3,4,4,5,5,6,6,7,7,8
,8,9,9,9-heptadecafluoro-
.
SN-23-0005............................ 2 12/30/2022 CBI...................... (G) The LCPFACs have no (S) Decanoic acid,
function or application. 2,2,3,3,4,4,5,5,6,6,7,7,8
,8,9,9,10,10,10-
nonadecafluoro-.
SN-23-0006............................ 2 12/30/2022 CBI...................... (G) The LCPFACs have no (S) Undecanoic acid,
function or application. 2,2,3,3,4,4,5,5,6,6,7,7,8
,8,9,9,10,10,11,11,11-
heneicosafluoro-.
SN-23-0007............................ 3 01/09/2023 Allnex USA, Inc.......... (S) EBECRYL MPDDA is a (S) 2-Propenoic acid, 1,1'-
difunctional acrylated (3-methyl-1,5-
monomer which pentanediyl) ester.
polymerizes when exposed
to sources of free
radicals such as
application in UV/EB
cured inks, additive
manufacturing,
adhesives, composites,
3D printing and coatings
systems, and is used as
an additive where
improved elasticity,
weathering, and adhesion
are desired in
combination with an
excellent water
resistance.
SN-23-0008............................ 2 12/30/2022 CBI...................... (G) The LCPFACs have no (S) Tetradecanoic acid,
function or application. 2,2,3,3,4,4,5,5,6,6,7,7,8
,8,9,9,10,10,11,11,12,12,
13,13,14,14,14-
heptacosafluoro-.
SN-23-0009............................ 2 12/30/2022 CBI...................... (G) The LCPFACs have no (S) Tridecanoic acid,
function or application. 2,2,3,3,4,4,5,5,6,6,7,7,8
,8,9,9,10,10,11,11,12,12,
13,13,13-pentacosafluoro-
.
[[Page 10324]]
SN-23-0010............................ 2 12/30/2022 CBI...................... (G) The LCPFACs have no (S) Hexadecanoic acid,
function or application. 2,2,3,3,4,4,5,5,6,6,7,7,8
,8,9,9,10,10,11,11,12,12,
13,13,14,14,15,15,16,16,1
6-.hentriacontafluoro-
SN-23-0011............................ 2 12/30/2022 CBI...................... (G) The LCPFACs have no (S) Octadecanoic acid,
function or application. 2,2,3,3,4,4,5,5,6,6,7,7,8
,8,9,9,10,10,11,11,12,12,
13,13,14,14,15,15,16,16,1
7,17,18,18,18-
pentatriacontafluoro-.
SN-23-0012............................ 4 01/04/2023 Dynax Corporation........ (G) Additive used in (G) Polyfluorinated alkyl
industrial and polyamide.
commercial applications.
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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 01/01/2023 to 01/31/2023
----------------------------------------------------------------------------------------------------------------
Commencement If amendment, type of
Case No. Received date date amendment Chemical substance
----------------------------------------------------------------------------------------------------------------
J-22-0015.................. 01/09/2023 01/06/2023 N.................... (G) Modified yeast,
chromosomally and stably
modified to improve
fermentation performance.
P-15-0691A................. 01/24/2023 07/21/2022 Amended generic (G) Polyamidoamine with
chemical name. substituted
ethyleneamine, sodium
salt.
P-15-0734A................. 01/24/2023 08/01/2022 Amended generic (G) Polyamidoamine with
chemical name. substituted
ethyleneamine, n-
carbodithioate, sodium
salt.
P-17-0235.................. 01/11/2023 11/28/2022 N.................... (G) Amidoamine quaternary
ammonium salt.
P-19-0186.................. 01/18/2023 01/18/2023 N.................... (S) Benzoic acid, 2-chloro-
5-methyl-, sodium salt
(1:1).
P-21-0137.................. 01/09/2023 09/09/2022 N.................... (G) Triazine-trione,
tris(isocyanatoalkyl)-,
polymer with substituted
diisocyanato
alkylcarbomonocycle, ydro-
hydroxypoly(oxyalkanediyl
) and hydro-
hydroxypoly[oxy(alkyl-
alkanediyl)], aliphatic
alkyl amine-blocked.
P-21-0138.................. 01/30/2023 01/17/2023 N.................... (G) Lithium metal oxide.
P-21-0176.................. 01/30/2023 12/29/2022 N.................... (S) Dodecanedioic acid,
1,12-bis[2-[4-(4,6-
diphenyl-1,3,5-triazin-2-
yl)-3-
hydroxyphenoxy]ethyl]este
r.
P-97-0954.................. 01/13/2023 10/23/2020 N.................... (G) Polymeric, alcohol-
blocked aromatic
isocyanate.
----------------------------------------------------------------------------------------------------------------
* 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 01/01/2023 to 01/31/2023
----------------------------------------------------------------------------------------------------------------
Case No. Received date Type of test information Chemical substance
----------------------------------------------------------------------------------------------------------------
P-14-0712........................ 01/11/2023 Polychlorinated Dibenzodioxins (S) Waste plastics,
and Polychlorinated pyrolyzed, C5-55 fraction.
dibenzofurans Testing.
P-16-0543........................ 01/18/2023 Exposure Monitoring Report...... (G) Halogenophosphoric acid
metal salt.
P-16-0543........................ 01/06/2023 Exposure Monitoring Report...... (G) Halogenophosphoric acid
metal salt.
P-18-0168........................ 01/27/2023 Surface Tension Testing......... (G) Alkoxylated triaryl
methane.
----------------------------------------------------------------------------------------------------------------
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.
[[Page 10325]]
Authority: 15 U.S.C. 2601 et seq.
Dated: February 13, 2023.
Pamela Myrick,
Director, Project Management and Operations Division, Office of
Pollution Prevention and Toxics.
[FR Doc. 2023-03362 Filed 2-16-23; 8:45 am]
BILLING CODE 6560-50-P
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