Certain New Chemicals; Receipt and Status Information for September 2022
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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 9/1/ 2022 to 9/30/2022.
Full Text
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<title>Federal Register, Volume 87 Issue 205 (Tuesday, October 25, 2022)</title>
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[Federal Register Volume 87, Number 205 (Tuesday, October 25, 2022)]
[Notices]
[Pages 64477-64481]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-23188]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2022-0132; FRL-9411-09-OCSPP]
Certain New Chemicals; Receipt and Status Information for
September 2022
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 9/1/
2022 to 9/30/2022.
DATES: Comments identified by the specific case number provided in this
document must be received on or before November 25, 2022.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2022-0132, 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#285a4940494106424145684d5849064f475e"><span class="__cf_email__" data-cfemail="7f0d1e171e16511516123f1a0f1e51181009">[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#9ecacddddfb3d6f1eaf2f7f0fbdefbeeffb0f9f1e8"><span class="__cf_email__" data-cfemail="a9fdfaeae884e1c6ddc5c0c7cce9ccd9c887cec6df">[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 09/01/2022 to 09/30/2022. 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.
[[Page 64478]]
B. What is the Agency's authority for taking this action?
Under the Toxic Substances Control Act (TSCA), 15 U.S.C. 2601 et
seq., a chemical substance may be either an ``existing'' chemical
substance or a ``new'' chemical substance. Any chemical substance that
is not on EPA's TSCA Inventory of Chemical Substances (TSCA Inventory)
is classified as a ``new chemical substance,'' while a chemical
substance that is listed on the TSCA Inventory is classified as an
``existing chemical substance.'' (See TSCA section 3(11).) For more
information about the TSCA Inventory please go to: <a href="https://www.epa.gov/tsca-inventory">https://www.epa.gov/tsca-inventory</a>.
Any person who intends to manufacture (including import) a new
chemical substance for a non-exempt commercial purpose, or to
manufacture or process a chemical substance in a non-exempt manner for
a use that EPA has determined is a significant new use, is required by
TSCA section 5 to provide EPA with a PMN, MCAN, or SNUN, as
appropriate, before initiating the activity. EPA will review the
notice, make a risk determination on the chemical substance or
significant new use, and take appropriate action as described in TSCA
section 5(a)(3).
TSCA section 5(h)(1) authorizes EPA to allow persons, upon
application and under appropriate restrictions, to manufacture or
process a new chemical substance, or a chemical substance subject to a
significant new use rule (SNUR) issued under TSCA section 5(a)(2), for
``test marketing'' purposes, upon a showing that the manufacture,
processing, distribution in commerce, use, and disposal of the chemical
will not present an unreasonable risk of injury to health or the
environment. This is referred to as a test marketing exemption, or TME.
For more information about the requirements applicable to a new
chemical go to: <a href="https://www.epa.gov/chemicals-under-tsca">https://www.epa.gov/chemicals-under-tsca</a>.
Under TSCA sections 5 and 8 and EPA regulations, EPA is required to
publish in the Federal Register certain information, including notice
of receipt of a PMN/SNUN/MCAN (including amended notices and test
information); an exemption application under 40 CFR part 725 (biotech
exemption); an application for a TME, both pending and concluded; NOCs
to manufacture a new chemical substance; and a periodic status report
on the new chemical substances that are currently under EPA review or
have recently concluded review.
C. Does this action apply to me?
This action provides information that is directed to the public in
general.
D. Does this action have any incremental economic impacts or paperwork
burdens?
No.
E. What should I consider as I prepare my comments for EPA?
1. Submitting confidential business information (CBI). Do not
submit this information to EPA through <a href="http://regulations.gov">regulations.gov</a> or email.
Clearly mark the part or all of the information that you claim to be
CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark
the outside of the disk or CD-ROM as CBI and then identify
electronically within the disk or CD-ROM the specific information that
is claimed as CBI. In addition to one complete version of the comment
that includes information claimed as CBI, a copy of the comment that
does not contain the information claimed as CBI must be submitted for
inclusion in the public docket. Information so marked will not be
disclosed except in accordance with procedures set forth in 40 CFR part
2.
2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at <a href="https://www.epa.gov/dockets/commenting-epa-dockets">https://www.epa.gov/dockets/commenting-epa-dockets</a>.
II. Status Reports
In the past, EPA has published individual notices reflecting the
status of TSCA section 5 filings received, pending or concluded. In
1995, the Agency modified its approach and streamlined the information
published in the Federal Register after providing notice of such
changes to the public and an opportunity to comment (see the Federal
Register of May 12, 1995 (60 FR 25798) (FRL-4942-7)). Since the passage
of the Lautenberg amendments to TSCA in 2016, public interest in
information on the status of section 5 cases under EPA review and, in
particular, the final determination of such cases, has increased. In an
effort to be responsive to the regulated community, the users of this
information, and the general public, to comply with the requirements of
TSCA, to conserve EPA resources and to streamline the process and make
it more timely, EPA is providing information on its website about cases
reviewed under the amended TSCA, including the section 5 PMN/SNUN/MCAN
and exemption notices received, the date of receipt, the final EPA
determination on the notice, and the effective date of EPA's
determination for PMN/SNUN/MCAN notices on its website at: <a href="https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/status-pre-manufacture-notices">https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/status-pre-manufacture-notices</a>. This information is updated on a
weekly basis.
III. Receipt Reports
For the PMN/SNUN/MCANs that have passed an initial screening by EPA
during this period, Table I provides the following information (to the
extent that such information is not subject to a CBI claim) on the
notices screened by EPA during this period: The EPA case number
assigned to the notice that indicates whether the submission is an
initial submission, or an amendment, a notation of which version was
received, the date the notice was received by EPA, the submitting
manufacturer (i.e., domestic producer or importer), the potential uses
identified by the manufacturer in the notice, and the chemical
substance identity.
As used in each of the tables in this unit, (S) indicates that the
information in the table is the specific information provided by the
submitter, and (G) indicates that this information in the table is
generic information because the specific information provided by the
submitter was claimed as CBI. Submissions which are initial submissions
will not have a letter following the case number. Submissions which are
amendments to previous submissions will have a case number followed by
the letter ``A'' (e.g., P-18-1234A). The version column designates
submissions in sequence as ``1'', ``2'', ``3'', etc. Note that in some
cases, an initial submission is not numbered as version 1; this is
because earlier version(s) were rejected as incomplete or invalid
submissions. Note also that future versions of the following tables may
adjust slightly as the Agency works to automate population of the data
in the tables.
[[Page 64479]]
Table I--PMN/SNUN/MCANs Approved * From 9/1/2022 to 9/30/2022
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Received
Case No. Version date Manufacturer Use Chemical substance
----------------------------------------------------------------------------------------------------------------
J-22-0021.............. 1 9/7/2022 Danisco US, Inc.... (G) Production of a (G) genetically
new chemical modified
substance. microorganism for
the production of
a chemical
substance.
P-18-0056A............. 10 9/14/2022 CBI................ (S) Rubber Adhesion (S) Cobalt
promoter. Use in Neodecanoate
the manufacturing Propionate
process of tires. complexes.
Acts as an oxygen
scavenger in
various
applications.
Industrial Use-
Tire Manufacturing.
P-20-0003.............. 5 7/28/2022 CBI................ (S) Photoinitiator (S) 2H-
for printing (UV, 1517Benzopyran-2-
LED, flexo, screen one, 5,7-dimethoxy-
and inkjet ink). , 3-(4 -C10-13-sec
-alkylbenzoyl)
derivs.
P-21-0076A............. 3 9/20/2022 CBI................ (S) Additive for (G) Alcohols, C16-
fluids used in oil 18 and C18-
drilling unsatd., reaction
operations. products with
subsstituted
alkyloxirane and
alkyl acid.
P-21-0202A............. 2 9/13/2022 CBI................ (G) An ingredient (G) Sulfonium,
used in the carbomonocycle
manufacture of bis[(trihaloalkyl)
photoresist. carbomonocycle],
substituted
carbomonocyclic
ester.
P-22-0001A............. 2 9/12/2022 CBI................ (G) Raw material (G) Alkane,
for manufacturing disubstituted.
chemicals; Raw
material used in
chemical
manufacturing.
P-22-0011A............. 4 8/31/2022 Lord Corporation... (G) Functionalized (G) Alkadiene,
rubber in resin homopolymer,
side of two hydroxy-
component epoxy terminated, bis[N-
modified acrylic [2-[(1-oxo-2-
adhesive. propen-1-
yl)oxylethyl]carba
mates].
P-22-0050A............. 4 9/6/2022 CBI................ (G) Lubricant...... (G) Alkene, alkoxy-
, polymer with
alkoxyalkene.
P-22-0057A............. 2 9/27/2022 CBI................ (G) Additive in (G) Polysaccharide,
home care products. polymer with 2-
propenoic acid,
sodium salt.
P-22-0082A............. 2 9/20/2022 CBI................ (G) Component of (G) Alkenoic acid,
photoresist. alkyl,
carbopolycyclic
alkyl ester,
polymer with
trihalo
(trihaloalkyl)
alkyl alkyl
alkenoate.
P-22-0144A............. 3 9/15/2022 United Color (G) Intermediate... (G) Alkylated
Manufacturing. PhenylNaphthylamin
e.
P-22-0163.............. 2 9/22/2022 Cnano Technology (S) As an Additive (S) Multiwalled
USA, Inc. Used in Battery Carbon Nanotubes.
Manufacture.
P-22-0164.............. 2 9/1/2022 CBI................ (G) Reactive (S) Fatty acids,
intermediate C18-unsatd.,
polyester polyol, dimers, polymers
diluent. with 1,4:3,6-
dianhydro-D-
glucitol, 1,3-
propanediol and
succinic acid.
P-22-0164A............. 3 9/12/2022 Danimer (G) Reactive (S) Fatty acids,
Bioplastics, Inc. intermediate C18-unsatd.,
polyester polyol, dimers, polymers
diluent. with 1,4:3,6-
dianhydro-D-
glucitol, 1,3-
propanediol and
succinic acid.
P-22-0165.............. 3 9/2/2022 Cytec Industries, (G) Industrial (G) Alkyl acid, 2-
Inc. process chemical. hydroxy-
,substituted alkyl
ester.
P-22-0169.............. 3 9/12/2022 Solugen, Inc....... (G) Additive for (G) Polycarboxylic
consumer, acid, salt.
commercial, and
industrial
applications.
P-22-0170.............. 3 9/12/2022 Solugen, Inc....... (G) Additive used (G) Polycarboxylic
in consumer, acid, salt.
commercial, and
industrial
applications.
P-22-0171.............. 3 9/12/2022 Solugen, Inc....... (G) Additive used (G) Polycarboxylic
in consumer, acid, salt.
commercial, and
industrial
applications.
P-22-0172.............. 3 9/12/2022 Solugen, Inc....... (G) Additive used (G) Polycarboxylic
in consumer, acid, salt.
commercial, and
industrial
applications.
P-22-0173.............. 3 9/12/2022 Solugen, Inc....... (G) Additive used (G) Polycarboxylic
in consumer, acid, salt.
commercial, and
industrial
applications.
P-22-0174.............. 3 9/12/2022 Solugen, Inc....... (G) Additive used (G) Polycarboxylic
in consumer, acid, salt.
commercial, and
industrial
applications.
P-22-0176.............. 1 9/1/2022 Colonial Chemical, (G) Corrosion (G) 6-[(alkyl-1-
Inc. inhibitor. oxohexyl)amino]-
hexanoic acid,
compd. with
2,2',2''-
nitrilotris[ethano
l] (1:1).
P-22-0176A............. 2 9/7/2022 Colonial Chemical, (G) Corrosion (G) 6-[(alkyl-1-
Inc. inhibitor. oxohexyl)amino]-
hexanoic acid,
compd. with
2,2',2''-
nitrilotris[ethano
l] (1:1).
P-22-0177.............. 1 9/6/2022 CBI................ (G) (G) Sulfonium,
Photolithography. tricarbocyclic-,
alpha, alpha,
beta, beta-
polyhalopolyhydro-
heteropolycyclic-5-
alkanesulfonate
(1:1).
P-22-0178.............. 2 9/13/2022 CBI................ (G) Adhesive for (G) Aromatic
lamination. diacid, polymer
with alkyldiols,
hexanedioc acid,
benzofurandione,
and 1,1'-
methylenebis[4-
isocyanatobenzene]
.
P-22-0179.............. 1 9/8/2022 Shin-Etsu Microsi.. (G) Contained use (G) Sulfonium,
for (alkylsubstitutedp
microlithography henyl)diphenyl-,
for electronic salt with 1-
device (heterosubstituted
manufacturing. alkyl)-2,2,2-
triheterosubstitut
edalkyl
trisubstitutedbenz
oate (1:1).
P-22-0180.............. 1 9/8/2022 Shin-Etsu Microsi.. (G) Contained use (G)
for Dibenzothiophenium
microlithography , 5-phenyl-, 4-[1-
for electronic (heterosubstituted
device alkyl)-2,2,2-
manufacturing. triheterosubstitut
edalkoxy]-4-
oxoalkyl
trisubstitutedbenz
oate (1:1).
P-22-0181.............. 1 9/12/2022 CBI................ (G) biobased (G) Fatty acids,
building block for polymers with
polymer. polyethylene
glycol ether with
polyol.
P-22-0183.............. 1 9/14/2022 Solugen, Inc....... (G) Additive for (G) Polycarboxylic
consumer, acid, reaction
commercial, and products with
industrial metal oxide salt,
applications. salts.
[[Page 64480]]
P-22-0184.............. 3 9/22/2022 United Color (G) Colorant....... (G) Transition
Manufacturing. metal complex of
(alkylated
phenylamino-
naphthalenylazo)-
(methylphenylazo
substituted)phenol
and alkyl amine.
P-22-0185.............. 1 9/16/2022 CBI................ (S) Chemical (S) 1,3,5-
intermediate. Cycloheptatriene.
P-22-0186.............. 1 9/21/2022 CBI................ (G) Oil Additive... (G) Phosphoric
acid, dialkyl
ester, transition
metal salt.
P-22-0188.............. 1 9/27/2022 Solugen, Inc....... (G) Additive for (G) Polycarboxylic
consumer, acid, reaction
commercial, and products with
industrial acid, salts.
applications.
P-22-0189.............. 1 9/27/2022 Solugen, Inc....... (G) Additive for (G) Polycarboxylic
consumer, acid, reaction
commercial, and products with
industrial inorganic salt,
applications. salts.
P-22-0190.............. 1 9/27/2022 Solugen, Inc....... (G) Additive for (G) Polycarboxylic
consumer, acid, reaction
commercial, and products with
industrial inorganic salt,
applications. salts.
P-22-0191.............. 1 9/27/2022 Solugen, Inc....... (G) Additive for (G) Polycarboxylic
consumer, acid, reaction
commercial, and products with
industrial acid, salts.
applications.
SN-22-0004A............ 3 9/7/2022 HPC Holdings, Inc.. (S) Carrier Fluid (S) Propane,
for coating-type 1,1,1,3,3,3-
vapor degreaser, hexafluoro-2-
Process Solvent methoxy-.
(Closed Systems).
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* 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 prior to the start of the 90 day review
period, and in no way reflects the final status of a complete submission review.
In Table II. of this unit, EPA provides the following information
(to the extent that such information is not subject to a CBI claim) on
the TMEs and/or Biotech Exemptions received by EPA during this period:
The EPA case number assigned to the TME and/or Biotech Exemption, the
submission document type (initial or amended), the version number, the
date the TME and/or Biotech Exemption was received by EPA, the
submitting manufacturer (i.e., domestic producer or importer), the
potential uses identified by the manufacturer in the TME and/or Biotech
Exemption, and the chemical substance identity.
Table II--TMEs and Biotech Exemptions Received From 9/1/2022 to 9/30/2022
----------------------------------------------------------------------------------------------------------------
Case No. Version Received date Manufacturer Use Chemical substance
----------------------------------------------------------------------------------------------------------------
T-22-0001............ 1 9/14/2022 CBI.............. (G) Functional (G) Mica-group
mineral for minerals, reaction
plastics, products with
automotive triethoxysilyl
components. substituted-alkane.
T-22-0001A........... 2 9/26/2022 CBI.............. (G) Functional (G) Mica-group
mineral for minerals, reaction
plastics, products with
automotive triethoxysilyl
components. substituted-alkane.
----------------------------------------------------------------------------------------------------------------
In Table III 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 III--NOCs Approved * From 9/1/2022 to 9/30/2022
----------------------------------------------------------------------------------------------------------------
If amendment,
Case No. Received date Commencement type of Chemical substance
date amendment
----------------------------------------------------------------------------------------------------------------
P-10-0039...................... 9/12/2022 8/23/2022 N (S) Multi-wall carbon
nanotubes.
P-11-0224...................... 9/29/2022 8/29/2022 N (G) Fluoro ether.
P-17-0306...................... 9/29/2022 9/12/2022 N (G) Fatty acid modified
aromatic polyester polyol
(this is the generic name
published in the final snur
for this substance).
P-18-0211...................... 9/21/2022 9/20/2021 N (G) Alkaneamine, (aminoalkyl)-
, polymer with aziridine and
1,6-diisocyanatohexane,
polyethylene glycol alkyl
ether- and polyethylene-
polypropylene glycol
aminoalkyl alkyl ether- and
alkenyl benzenated
polyethylene glycol ph ether.
P-18-0398...................... 9/13/2022 8/17/2022 N (S) 1,2-ethanediamine, n-1-(1-
methylethyl)-n-2-[2-[(1-
methylethyl)amino]ethyl].
P-21-0187...................... 9/29/2022 9/14/2022 N (G) Glycerine, alkoxylated
alkyl acid esters.
----------------------------------------------------------------------------------------------------------------
* 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 IV 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.
[[Page 64481]]
Table IV--Test Information Received From 9/1/2022 to 9/30/2022
----------------------------------------------------------------------------------------------------------------
Case No. Received date Type of test information Chemical substance
----------------------------------------------------------------------------------------------------------------
P-16-0543........................ 9/1/2022 Industrial Hygiene Exposure (G) Halogenophosphoric acid
Report. metal salt.
P-21-0138........................ 9/12/2022 Product Identity and Composition (G) Lithium compound.
(OCSPP Tet Guideline 830.1550);
Particle Size, Fiber Length,
and Diameter Distribution
Testing (OECD Test Guideline
110); Sediment and Soil
Adsorption/Desorption Isotherm
Testing (OECD Test Guideline
106); Dissociation Constants in
Water (OECD Test Guideline
112); Fish Bioconcentration
Factor BCF Testing (OECD Test
Guideline 305); Chronic Fish
Testing; Freshwater and
Saltwater Fish Acute Toxicity
Testing (OECD Test Guideline
203); Modified Activated
Sludge, Respiration Inhibition
Testing (OCSPP Test Guideline
850.3300); Acute Dermal
Toxicity Testing (OECD Test
Guideline 402); Daphnid Chronic
Toxicity Testing (OECD Test
Guideline 211); Earthworm
Subchronic Toxicity Testing
(OCSPP Test Guideline
850.3100); Prenatal
Developmental Toxicity Study
(OECD Test Guideline 414).
----------------------------------------------------------------------------------------------------------------
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: October 18, 2022.
Todd Holderman,
Acting Director, Project Management and Operations Division, Office of
Pollution Prevention and Toxics.
[FR Doc. 2022-23188 Filed 10-24-22; 8:45 am]
BILLING CODE 6560-50-P
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