[Federal Register Volume 88, Number 221 (Friday, November 17, 2023)]
[Notices]
[Pages 80294-80298]
[FR Doc No: 2023-25437]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2023-0061; FRL-10581-10-OCSPP]

Certain New Chemicals; Receipt and Status Information for October
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 10/01/
2023 to 10/31/2023.

DATES: Comments identified by the specific case number provided in this
document must be received on or before December 18, 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/.

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 10/01/2023 to 10/31/2023. 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: https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/status-pre-manufacture-notices. This information is updated on a
weekly basis.

B. What is the Agency's authority for taking this action?

    Under the Toxic Substances Control Act (TSCA), 15 U.S.C. 2601 et
seq., a chemical substance may be either an ``existing'' chemical
substance or a ``new'' chemical substance. Any chemical substance that
is not on EPA's TSCA Inventory of Chemical Substances (TSCA Inventory)
is classified as a ``new chemical substance,'' while a chemical
substance that is listed on the TSCA Inventory is classified as an
``existing chemical substance.'' (See TSCA section 3(11).) For more
information about the TSCA Inventory please go to: https://www.epa.gov/tsca-inventory.
    Any person who intends to manufacture (including import) a new
chemical substance for a non-exempt commercial purpose, or to
manufacture or process a chemical substance in a non-exempt manner for
a use that EPA has determined is a significant new use, is required by
TSCA section 5 to provide EPA with a PMN, MCAN, or SNUN, as
appropriate, before initiating the activity. EPA will review the
notice, make a risk determination on the chemical substance or
significant new use, and take appropriate action as described in TSCA
section 5(a)(3).
    TSCA section 5(h)(1) authorizes EPA to allow persons, upon
application and under appropriate restrictions, to manufacture or
process a new chemical substance, or a chemical substance subject to a
significant new use rule (SNUR) issued under TSCA section 5(a)(2), for
``test marketing'' purposes, upon a showing that the manufacture,
processing, distribution in commerce, use, and disposal of the chemical
will not present an unreasonable risk of injury to health or the
environment. This is referred to as a test marketing exemption, or TME.
For more information about the requirements applicable to a new
chemical go to: https://www.epa.gov/chemicals-under-tsca.
    Under TSCA sections 5 and 8 and EPA regulations, EPA is required to
publish in the Federal Register certain information, including notice
of receipt of a PMN/SNUN/MCAN (including amended notices and test
information); an exemption application under 40 CFR part 725 (biotech
exemption); an application for a TME, both pending and concluded; NOCs
to manufacture a new chemical substance; and a periodic status report
on the new chemical

substances that are currently under EPA review or have recently
concluded review.

C. Does this action apply to me?

    This action provides information that is directed to the public in
general.

D. Does this action have any incremental economic impacts or paperwork
burdens?

    No.

E. What should I consider as I prepare my comments for EPA?

    1. Submitting confidential business information (CBI). Do not
submit this information to EPA through regulations.gov or email.
Clearly mark the part or all of the information that you claim to be
CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark
the outside of the disk or CD-ROM as CBI and then identify
electronically within the disk or CD-ROM the specific information that
is claimed as CBI. In addition to one complete version of the comment
that includes information claimed as CBI, a copy of the comment that
does not contain the information claimed as CBI must be submitted for
inclusion in the public docket. Information so marked will not be
disclosed except in accordance with procedures set forth in 40 CFR part
2.
    2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at https://www.epa.gov/dockets/commenting-epa-dockets.

II. Status Reports

    In the past, EPA has published individual notices reflecting the
status of TSCA section 5 filings received, pending, or concluded. In
1995, the Agency modified its approach and streamlined the information
published in the Federal Register after providing notice of such
changes to the public and an opportunity to comment (see the Federal
Register of May 12, 1995 (60 FR 25798) (FRL-4942-7)). Since the passage
of the Lautenberg amendments to TSCA in 2016, public interest in
information on the status of section 5 cases under EPA review and, in
particular, the final determination of such cases, has increased. In an
effort to be responsive to the regulated community, the users of this
information, and the general public, to comply with the requirements of
TSCA, to conserve EPA resources and to streamline the process and make
it more timely, EPA is providing information on its website about cases
reviewed under the amended TSCA, including the section 5 PMN/SNUN/MCAN
and exemption notices received, the date of receipt, the final EPA
determination on the notice, and the effective date of EPA's
determination for PMN/SNUN/MCAN notices on its website at: https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/status-pre-manufacture-notices. This information is updated on a
weekly basis.

III. Receipt Reports

    For the PMN/SNUN/MCANs that have passed an initial screening by EPA
during this period, Table I provides the following information (to the
extent that such information is not subject to a CBI claim) on the
notices screened by EPA during this period: The EPA case number
assigned to the notice that indicates whether the submission is an
initial submission, or an amendment, a notation of which version was
received, the date the notice was received by EPA, the submitting
manufacturer (i.e., domestic producer or importer), the potential uses
identified by the manufacturer in the notice, and the chemical
substance identity.
    As used in each of the tables in this unit, (S) indicates that the
information in the table is the specific information provided by the
submitter, and (G) indicates that this information in the table is
generic information because the specific information provided by the
submitter was claimed as CBI. Submissions which are initial submissions
will not have a letter following the case number. Submissions which are
amendments to previous submissions will have a case number followed by
the letter ``A'' (e.g. P-18-1234A). The version column designates
submissions in sequence as ``1'', ``2'', ``3'', etc. Note that in some
cases, an initial submission is not numbered as version 1; this is
because earlier version(s) were rejected as incomplete or invalid
submissions. Note also that future versions of the following tables may
adjust slightly as the Agency works to automate population of the data
in the tables.

                         Table I--PMN/SNUN/MCANs Approved* From 10/01/2023 to 10/31/2023
----------------------------------------------------------------------------------------------------------------
                                     Received
        Case No.          Version      date        Manufacturer           Use             Chemical substance
----------------------------------------------------------------------------------------------------------------
P-21-0165A.............         3   10/23/2023  Colonial           (S) Anionic        (S) D-Glucopyranose,
                                                 Chemical, Inc.     surfactant in      oligomeric, C10-16-alkyl
                                                                    cleaning           glycosides, 3-(3,4-
                                                                    products.          dicarboxy-3-hydroxy-1-
                                                                                oxobutoxy)-2-
                                                                                hydroxypropyl ethers,
                                                                                sodium salts.
P-22-0023A.............         2   09/28/2023  CBI..............  (G) Catalyst       (G) Alkyldioic acid,
                                                                    system component.  bis(alkylalkyl)-,
                                                                                polyalkyl ester.
P-22-0023A.............         3   10/13/2023  CBI..............  (G) Catalyst       (G) Alkyldioic acid,
                                                                    system component.  bis(alkylalkyl)-,
                                                                                polyalkyl ester.
P-22-0040A.............         4   10/16/2023  CBI..............  (G) Component      (S) Manganate(4-),
                                                                    used in            hexakis(cyano-.kappa.C)-,
                                                                    manufacture of     manganese (2+) sodium,
                                                                    high-              (OC-6-11)-.
                                                                    performance
                                                                    batteries.
P-22-0041A.............         4   10/16/2023  CBI..............  (G) A component    (S) Ferrate (-4),
                                                                    used in the        hexakis(cyano-.kappa.C)-,
                                                                    manufacture of     iron(3+) manganese(2+)
                                                                    batteries.         sodium, (OC-6-11)-.
P-22-0168A.............         4   10/11/2023  Colonial           (S) The product    (G) Amides, alkyl, N-[3-
                                                 Chemical, Inc.     is used as a       (dimethylamino)propyl].
                                                                    reaction
                                                                    intermediate to
                                                                    make surfactant
                                                                    end-products. It
                                                                    is not sold
                                                                    commercially or
                                                                    used outside of
                                                                    our
                                                                    manufacturing
                                                                    facility..

P-23-0134A.............         4   10/11/2023  CBI..............  (G)                (S) Poly[oxy(methyl-1,2-
                                                                    Photoinitiator     ethanediyl)],alpha-hydro-
                                                                    for UV curing of   omega-{[2-[(1-chloro-9-
                                                                    monomeric and      oxo-9H-thioxanthen-4-
                                                                    oligomeric         yl)oxy]acetyl]oxy{time} -
                                                                    acrylate-based     ,ether with 2,2-
                                                                    printing inks.     bis(hydroxymethyl)-1,3-
                                                                                propanediol (4:1).
P-23-0154A.............         4   10/04/2023  RWDC Industries..  (G) The primary    (G) Vegetable oils,
                                                                    application        genetically modified
                                                                    areas for PHA      Cupriavidus-fermented,
                                                                    are for food       polyhydroxyalkanoate
                                                                    packaging and      copolymer.
                                                                    other uses where
                                                                    its
                                                                    biodegradable
                                                                    properties
                                                                    provide
                                                                    nontraditional
                                                                    end-of-use
                                                                    options.
P-23-0165A.............         4   09/29/2023  CBI..............  (G) Production     (G) 2,3,3,3-tetrafluoro-2-
                                                                    aide for the       [(polyfluoroalken-1-
                                                                    manufacturing of   yl)oxy]-propanoic acid
                                                                    polymers.          homopolymer.
P-23-0168A.............         3   10/13/2023  Central Glass      (G) Battery        (G) Sulfamoyl halide
                                                 International,     production.        fluorophosphate salt.
                                                 Inc.
P-23-0192..............         1   09/27/2023  Colonial           (S) Metal working  (G) Amides, fatty acid,
                                                 Chemical, Inc.     applications.      N,N-bis(2-hydroxypropyl).
P-23-0193..............         1   09/27/2023  CBI..............  (G) Component of   (G) Substituted
                                                                    lenses used in     carbopolycyclic
                                                                    electronic         dicarboxylic acid dialkyl
                                                                    applications.      ester, polymer with
                                                                                alkanediol,
                                                                                carbopolycyclic
                                                                                bis(substituted
                                                                                carbopolycycle)bis[alkano
                                                                                l] and carbopolycyclic
                                                                                bis(substituted
                                                                                carbomonocycle)bis[alkano
                                                                                l].
P-23-0194..............         1   09/29/2023  CBI..............  (G) Lubricant      (G) Amines, alkyl and
                                                                    additive.          alkenyl, 2-ethylhexyl
                                                                                phosphates.
P-24-0004..............         1   10/05/2023  CBI..............  (G) Plastic        (G) Benzoylated amino acid
                                                                    production aid.    salt.
P-24-0005..............         3   10/24/2023  CBI..............  (G) Plastic        (G) Polycarbomonocyclic
                                                                    article            diol reaction products
                                                                    production.        with
                                                                                cycloalkylcarbomonocycle
                                                                                and polysubstituted
                                                                                heteromonocycle.
P-24-0005A.............         4   10/25/2023  CBI..............  (G) Plastic        (G) Polycarbomonocyclic
                                                                    article            diol reaction products
                                                                    production.        with
                                                                                cycloalkylcarbomonocycle
                                                                                and polysubstituted
                                                                                heteromonocycle.
P-24-0005A.............         5   10/25/2023  CBI..............  (G) Plastic        (G) Polycarbomonocyclic
                                                                    article            diol reaction products
                                                                    production.        with
                                                                                cycloalkylcarbomonocycle
                                                                                and polysubstituted
                                                                                heteromonocycle.
P-24-0009..............         1   10/19/2023  Chevron Phillips   (S) Heat transfer  (S) Eicosane, branched and
                                                 Chemical           agent for          linear.
                                                 Company, LP.       direct,
                                                                    immersive liquid
                                                                    cooling of
                                                                    electronic
                                                                    components; (S)
                                                                    Synthetic base
                                                                    oil for use in
                                                                    lubricants; (S)
                                                                    Lubricity
                                                                    additive for
                                                                    drilling fluids.
P-24-0011..............         1   10/24/2023  High Plains        (S) Used as a      (S) Alkanes, C5-11-
                                                 Bioenergy, LLC.    component of       branched and linear.
                                                                    fuels (e.g.,
                                                                    gasoline, E85)
                                                                    to increase the
                                                                    vapor pressure;
                                                                    (S) Chemical
                                                                    intermediate use
                                                                    (e.g.,
                                                                    petrochemical
                                                                    feedstock).
P-24-0013..............         1   10/26/2023  Momentive          (S) Resin/binder   (G) Siloxanes and
                                                 Performance        in paint           Silicones, di-Me, hydroxy-
                                                 Materials.         formulations for   terminated, polymers with
                                                                    industrial         3-[[3-alkoxy-1-
                                                                    coatings.          (alkoxycarbonyl)-3-
                                                                                oxoalkyl]heteroatom]propy
                                                                                l Me silsesquioxanes,
                                                                                alkoxy-terminated.

SN-21-0006A............         3   10/30/2023  Carbice..........  (S) For heat       (S) Multiwalled carbon
                                                                    transfer, heat     nanotubes grown
                                                                    storage, thermal   perpendicularly on an
                                                                    emission, and      aluminum foil substrate
                                                                    general            using Fe catalyst.
                                                                    temperature
                                                                    management in
                                                                    heat-generating
                                                                    systems such as
                                                                    electronics; (S)
                                                                    To improve
                                                                    mechanical
                                                                    properties or
                                                                    electrical
                                                                    conduciveness of
                                                                    other materials
                                                                    or products; (S)
                                                                    For light
                                                                    absorption
                                                                    properties; (S)
                                                                    Gap filling or
                                                                    sealing of
                                                                    opposing
                                                                    interfaces.
----------------------------------------------------------------------------------------------------------------

    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 10/01/2023 to 10/31/2023
----------------------------------------------------------------------------------------------------------------
                                                  Commencement     If amendment, type of
           Case No.              Received date        date               amendment          Chemical substance
----------------------------------------------------------------------------------------------------------------
P-13-0355.....................      10/10/2023        08/31/2023  N                       (S) Phenol, 2,6-
                                                                                dimethyl-,
                                                                                homopolymer, ether
                                                                                with 2,2'', 3,3'',
                                                                                5,5''-hexamethyl
                                                                                [1,1'-biphenol]-4,
                                                                                4''-diol (2:1).
P-22-0057.....................      10/30/2023        10/13/2023  N                       (G) Polysaccharide,
                                                                                polymer with 2-
                                                                                propenoic acid,
                                                                                sodium salt.
----------------------------------------------------------------------------------------------------------------

    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 10/01/2023 to 10/31/2023.
----------------------------------------------------------------------------------------------------------------
                                                                  Type of test
              Case No.                    Received date           information             Chemical substance
----------------------------------------------------------------------------------------------------------------
P[dash]14[dash]0712.................            10/12/2023  Polychlorinated          (S) Waste plastics,
                                                             Dibenzodioxins and       pyrolyzed, C5-55 fraction
                                                             Polychlorinated
                                                             dibenzofurans Testing.
P[dash]18[dash]0304.................            10/04/2023  PAG 2A Direct            (G) Sulfonium,
                                                             Photolysis Study         bis(dihalocarbomonocycle)
                                                             Report,.                 carbomonocycle, salt with
                                                            PAG 3A Direct             substituted
                                                             Photolysis Study         heteropolycycle dihalo
                                                             Report,.                 sulfoalkanoate (1:1).
                                                            PAG 5 Direct Photolysis
                                                             Study Report.
P[dash]19[dash]0079,                            10/06/2023  PAG 2A Direct            (G) Substituted
 P[dash]19[dash]0111,                                        Photolysis Study         heterocyclic onium
 P[dash]19[dash]0112,                                        Report,.                 compound, salt with 2,2,2-
 P[dash]19[dash]0114,                                       PAG 3A Direct             trifluoro-1-(sulfomethyl)-
 P[dash]19[dash]0133.                                        Photolysis Study         1-(trifluoromethyl)ethyl 3-
                                                             Report,.                 [(2-methyl-1-oxo-2-propen-
                                                            PAG 5 Direct Photolysis   1-
                                                             Study Report.            yl)oxy]tricyclo[<IP_ADDRESS>,7
                                                                                ]decane-1- carboxylate
                                                                                (1:1), polymer with
                                                                                acenaphthylene, 1-ethenyl-
                                                                                4-[[1-(1-
                                                                                methylethyl)cyclopentyl]ox
                                                                                y]benzene and 4-
                                                                                ethenylphenol, di-me 2,2'-
                                                                                (1,2-diazenediyl)bis[2-
                                                                                methylpropanoate]-
                                                                                initiated.

P[dash]20[dash]0122,                             10/6/2023  PAG 2A Direct            (S) 1-(4-tert-
 P[dash]20[dash]0139,                                        Photolysis Study         butylphenyl)tetrahydro[2-
 P[dash]20[dash]0140,                                        Report,.                 \14\C]thiophen-1-ium
 P[dash]20[dash]0141,                                       PAG 3A Direct             nonaflate; (S) (4-
 P[dash]20[dash]0142.                                        Photolysis Study         hydroxy[U-\14\C]phenyl)-
                                                             Report,.                 diphenyl-sulfonium
                                                            PAG 5 Direct Photolysis   trifluoromethanesulfonate;
                                                             Study Report.            (S) tris(4-tert-butyl[mono-
                                                                                U-\14\C]phenyl)sulfonium
                                                                                nonaflate.
P[dash]20[dash]0145,                             10/6/2023  PAG 2A Direct            (S) 1-(4-tert-
 P[dash]20[dash]0147,                                        Photolysis Study         butylphenyl)tetrahydro[2-
 P[dash]20[dash]0152,                                        Report,.                 \14\C]thiophen-1-ium
 P[dash]20[dash]0155,                                       PAG 3A Direct             nonaflate; (S) (4-
 P[dash]20[dash]0159.                                        Photolysis Study         hydroxy[U-\14\C]phenyl)-
                                                             Report,.                 diphenyl-sulfonium
                                                            PAG 5 Direct Photolysis   trifluoromethanesulfonate;
                                                             Study Report.            (S) tris(4-tert-butyl[mono-
                                                                                U-\14\C]phenyl)sulfonium
                                                                                nonaflate.
P[dash]17[dash]0178,                             10/6/2023  PAG 2A Direct            (S) 1-(4-tert-
 P[dash]18[dash]0013,                                        Photolysis Study         butylphenyl)tetrahydro[2-
 P[dash]18[dash]0014,                                        Report,.                 \14\C]thiophen-1-ium
 P[dash]18[dash]0037,                                       PAG 3A Direct             nonaflate; (S) (4-
 P[dash]19[dash]0078.                                        Photolysis Study         hydroxy[U-\14\C]phenyl)-
                                                             Report,.                 diphenyl-sulfonium
                                                            PAG 5 Direct Photolysis   trifluoromethanesulfonate;
                                                             Study Report.            (S) tris(4-tert-butyl[mono-
                                                                                U-\14\C]phenyl)sulfonium
                                                                                nonaflate.
P[dash]22[dash]0129,                             10/6/2023  PAG 2A Direct            (S) 1-(4-tert-
 P[dash]23[dash]0050.                                        Photolysis Study         butylphenyl)tetrahydro[2-
                                                             Report,.                 \14\C]thiophen-1-ium
                                                            PAG 3A Direct             nonaflate; (S) (4-
                                                             Photolysis Study         hydroxy[U-\14\C]phenyl)-
                                                             Report,.                 diphenyl-sulfonium
                                                            PAG 5 Direct Photolysis   trifluoromethanesulfonate;
                                                             Study Report.            (S) tris(4-tert-butyl[mono-
                                                                                U-\14\C]phenyl)sulfonium
                                                                                nonaflate.
P[dash]19[dash]0079,                            10/27/2023  PAG 2 Direct Photolysis  (S) tri[mono-U-
 P[dash]19[dash]0111,                                        Study Report.            \14\C]phenylsulfonium 2-
 P[dash]19[dash]0112,                                                                 (adamantane-1-
 P[dash]19[dash]0114,                                                                 carbonyloxy)-1,1-difluoro-
 P[dash]19[dash]0133.                                                                 ethanesulfonate.
P[dash]20[dash]0122,                            10/27/2023  PAG 2 Direct Photolysis  (S) tri[mono-U-
 P[dash]20[dash]0139,                                        Study Report.            \14\C]phenylsulfonium 2-
 P[dash]20[dash]0140,                                                                 (adamantane-1-
 P[dash]20[dash]0141,                                                                 carbonyloxy)-1,1-difluoro-
 P[dash]20[dash]0142.                                                                 ethanesulfonate
P[dash]20[dash]0145,                            10/27/2023  PAG 2A Direct            (S) tri[mono-U-
 P[dash]20[dash]0147,                                        Photolysis Study         \14\C]phenylsulfonium 2-
 P[dash]20[dash]0152,                                        Report.                  (adamantane-1-
 P[dash]20[dash]0155,                                                                 carbonyloxy)-1,1-difluoro-
 P[dash]20[dash]0159.                                                                 ethanesulfonate.
P[dash]22[dash]0129,                            10/27/2023  PAG 2 Direct Photolysis  (S) tri[mono-U-
 P[dash]23[dash]0050.                                        Study Report.            \14\C]phenylsulfonium 2-
                                                                                (adamantane-1-
                                                                                carbonyloxy)-1,1-difluoro-
                                                                                ethanesulfonate
P[dash]17[dash]0178,                            10/27/2023  PAG 2 Direct Photolysis  (S) tri[mono-U-
 P[dash]18[dash]0013,                                        Study Report.            \14\C]phenylsulfonium 2-
 P[dash]18[dash]0014,                                                                 (adamantane-1-
 P[dash]18[dash]0037,                                                                 carbonyloxy)-1,1-difluoro-
 P[dash]19[dash]0078.                                                                 ethanesulfonate.
P[dash]11[dash]0557.................            10/31/2023  Annual reporting of      (G) 2-Propenoic acid, 2-
                                                             Certificate of           methyl-, 2-hydroxyethyl
                                                             Analysis test data and   ester, telomers with C18-
                                                             import volumes.          26-alkyl acrylate, 1-
                                                                                dodecanethiol, N-
                                                                                (hydroxymethyl)-2-methyl-2-
                                                                                propenamide,
                                                                                polyfluorooctyl
                                                                                methacrylate and
                                                                                vinylidene chloride, 2,2'-
                                                                                [1 ,2-diazenediylbis(1-
                                                                                methylethylidene)bis[4,5-
                                                                                dihydro-1 H-imidazole]
                                                                                hydrochloride (1 :2)-
                                                                                initiated.
----------------------------------------------------------------------------------------------------------------

    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: November 13, 2023.
Pamela Myrick,
Director, Project Management and Operations Division, Office of
Pollution Prevention and Toxics.
[FR Doc. 2023-25437 Filed 11-16-23; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 74, Number 85 (Tuesday, May 5, 2009)]
[Notices]
[Pages 20778-20779]
[FR Doc No: E9-10340]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2006-26367]

Motor Carrier Safety Advisory Committee Public Meeting

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of Motor Carrier Safety Advisory Committee Meeting.

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SUMMARY: FMCSA announces that the Motor Carrier Safety Advisory
Committee (MCSAC) will hold a committee meeting. The meeting is open to
the public.

DATES: The MCSAC will hold two public sessions at its May meeting. The
first will be held on Monday, May 18, 2009, from 10-11 a.m. (EDT), and
will include a discussion between FMCSA management and the MCSAC
committee on Task 09-02. This task was assigned at the MCSAC meeting on
March 18 and asked the committee for suggestions on implementing a new
cross-border trucking program between the United States and Mexico. The
meeting will be held via conference call. Should you wish to
participate, please contact Shannon L. Watson at<PHONE_NUMBER> or via
e-mail at<EMAIL_ADDRESS>by Wednesday, May 13, to receive
information on how to access the call.
    The May 20, 2009, public meeting will be held from 1-4 p.m. (EDT).

ADDRESSES: The May 20 meeting will be held at the U.S. Department of
Transportation, Media Center, West Building, Ground Floor, 1200 New
Jersey Avenue, SE., Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Mr. Jeffrey K. Miller, Chief,
Strategic Planning and Program Evaluation Division, Office of Policy
Plans and Regulation, Federal Motor Carrier Safety Administration, U.S.
Department of Transportation, 1200 New Jersey Avenue, SE., Washington,
DC 20590,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    Section 4144 of the Safe, Accountable, Flexible, Efficient
Transportation Equity Act: A Legacy for Users (SAFETEA-LU, Pub. L. 109-
59) required the Secretary of the U.S. Department of Transportation to
establish a Motor Carrier Safety Advisory Committee in FMCSA. The
advisory committee provides advice and recommendations to the FMCSA
Administrator on motor carrier safety programs and motor carrier safety
regulations. The advisory committee operates in accordance with the
Federal Advisory Committee Act (5 U.S.C. App. 2). The Committee is
comprised of 15 members appointed by the Administrator.

II. Meeting Participation

    Both meetings are open to the public. FMCSA invites participation
by all interested parties, including motor carriers, drivers, and
representatives of motor carrier associations. Please note that
attendees for the May 20, 2009, meeting will need to be pre-cleared in
advance of the meeting in order to expedite entry into the building. By
May 13, 2009, please e-mail<EMAIL_ADDRESS>if you plan to attend the
meeting to facilitate the pre-clearance security process. For
information on facilities or services for individuals with disabilities
or to request special assistance at the meeting, please e-mail
<EMAIL_ADDRESS>by May 13, 2009.
    As a general matter, the Committee will allocate one hour for
public comments on, May 20, 2009, from 3 p.m. to 4 p.m.. Individuals
wishing to address the committee should send an

e-mail to<EMAIL_ADDRESS>by May 13, 2009. The time available will be
divided among those who have signed up to address the committee, but no
one will be allotted more than 15 minutes. For a copy of the agenda,
please send an e-mail to<EMAIL_ADDRESS>    Individuals with a desire to present written materials to the
committee should submit written comments identified by Federal Docket
Management System (FDMC) Docket Number FMCSA-2006-26367 using any of
the following methods:

     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the online instructions for submitting
comments.
     Fax:<PHONE_NUMBER>.
     Mail: Docket Management Facility; U.S. Department of
Transportation, 1200 New Jersey Avenue, SE., West Building, Room W12-
140, Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, 1200 New
Jersey Avenue, SE., Room W12-140, Washington, DC, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays.

    Issued on: April 30, 2009.
Larry W. Minor,
Associate Administrator for Policy and Program Development.
[FR Doc. E9-10340 Filed 5-4-09; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register Volume 77, Number 160 (Friday, August 17, 2012)]
[Notices]
[Pages 49856-49857]
[FR Doc No: 2012-20245]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

Environmental Impact Statement for the Salinas to San Luis Obispo
Portion of the Coast Corridor: Monterey and San Luis Obispo Counties,
CA

AGENCY: Federal Railroad Administration (FRA), U.S. Department of
Transportation (DOT).

ACTION: Notice of Intent to Prepare an Environmental Impact Statement.

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SUMMARY: FRA is issuing this notice to advise the public that FRA and
the California Department of Transportation (Caltrans) will jointly
prepare an Environmental Impact Statement (EIS)/Environmental Impact
Report (EIR) to study potential service upgrades and rail corridor
improvements to the Salinas to San Luis Obispo portion of the Coast
Corridor. The objective of the EIS/EIR is to evaluate alternatives and
present environmental analysis to help make decisions regarding the
type of service upgrades and rail improvements to be provided in the
corridor, including variations in train frequency, trip time, and on-
time performance. FRA is also issuing this notice to solicit public and
agency input into the development of the scope of the EIS/EIR, whether
to tier the environmental process, and to advise the public that public
and agency participation resulting from outreach activities conducted
by Caltrans and its representatives will be considered in the
preparation of the EIS/EIR.

DATES: Written comments on the scope of the EIS/EIR for the Salinas to
San Luis Obispo Portion of the Coast Corridor should be provided to
Caltrans no later than September 10, 2012. Public scoping meetings are
scheduled on August 28 and August 29, 2012 at the times and locations
identified in the Addresses section below.

ADDRESSES: Written comments on the scope of this study should be sent
to Ms. Emily Burstein, Division of Rail, Office of Planning and Policy,
California Department of Transportation, 1120 N Street, MS 74,
Sacramento, CA 95814 or via email to
<EMAIL_ADDRESS>Comments may also be
provided orally or in writing at the public scoping meetings scheduled
at the following locations:

Salinas

Tuesday, August 28, 2012, 3:30 p.m.-6:00 p.m., Transportation Authority
for Monterey County (TAMC), TAMC Conference Room, 55 Plaza Circle
B, Salinas, CA 93901.

San Luis Obispo

Wednesday, August 29, 2012, 3:30 p.m.-6:00 p.m., San Luis Obispo County
Library Community Room, 995 Palm Street, San Luis Obispo, CA 93401.

FOR FURTHER INFORMATION CONTACT: Regarding the environmental review
please contact: Ms. Emily Burstein, Division of Rail, Office of
Planning and Policy, California Department of Transportation, 1120 N
Street, MS 74, Sacramento, CA 95814 (telephone:<PHONE_NUMBER>) or Ms.
Stephanie Perez, Environmental Protection Specialist, Office of
Railroad Policy and Development, Federal Railroad Administration, 1200
New Jersey Avenue SE., Mail Stop 20, Washington, DC 20590 (telephone:
(202) 493-0388).

SUPPLEMENTARY INFORMATION:

Purpose and Need

    The greater Coast Corridor region from San Jose, California to Los
Angeles, California faces significant mobility challenges today. These
challenges are likely to continue in the future as continued growth in
population, employment, and tourism activity is expected to generate
increased travel demand. By 2040, statewide population is expected to
grow substantially, further straining the existing transportation
network. An effective rail system is necessary to meet the future
mobility needs of residents, businesses, and visitors. The Coast
Corridor faces continuing transportation challenges as evidenced by the
following:
     Constrained Travel Options--While the Coast Corridor is
served by a transportation system that includes air, highway, and rail
modes system access and capacity is insufficient to meet future travel
demand. Air access is limited for many residents because major airports
are located at a substantial distance outside the Salinas to San Luis
Obispo portion of the corridor. This portion of the corridor is served
by a single major highway--US 101--which experiences frequent
congestion and travel delays. Amtrak offers a single daily Coast
Starlight passenger service along the corridor and trains are often
delayed due to the primarily single-track rail system operating beyond
its design capacity.
     Significant Highway Congestion--While travel by automobile
is expected to meet the majority of future travel demand, this
increased use will result in worsening of existing congestion.
Congestion is particularly acute at the corridor's urban chokepoints
and is likely to worsen, making travel times unreliable. In addition,
space constraints limit the potential to expand the highway system.
     Constrained Rail System Capacity--Corridor rail service
could accommodate an increasing portion of projected travel demand
growth by providing an alternative mode to automobile travel, but rail
service is constrained by infrastructure that is significantly
undersized for the volumes it currently accommodates, much less future
service, without significant system improvements. Moreover, the
existing Coast Starlight service is often fully booked during peak
travel periods.
     Aging Rail Infrastructure--Investment in corridor rail
service has not kept pace with population and travel demand growth, and
many tracks, signals and bridges have not been upgraded or improved in
decades. Improvements would allow shorter travel times and greater
reliability, making rail a more attractive and competitive choice.
     Safety Concerns - Increasing potential for accidents in
congested rail chokepoints underscores the need for upgraded signaling
and infrastructure investments. Growing frequency of rail-related
collisions call for improved highway/rail crossings and new or upgraded
pedestrian crossings.
     Need for Increased Travel Capacity Without Impacting Air
Quality and Natural Resources--Highway capacity improvements can have
negative impacts on regional and local air quality as well as the
efficient use of natural resources. Simultaneously expanding travel
capacity while meeting federal and state air quality standards will
likely require reductions in total vehicle miles traveled. Rail system
improvements offer the opportunity to achieve air quality benefits with
minimal impact on natural resources.
    In light of the transportation challenges listed above, Caltrans
has identified rail improvements to the Coast Corridor as an
opportunity to

improve mobility and reliability in this congested part of the state's
rail system. The proposed improvements would allow for a more reliable,
safe, competitive, and attractive intercity travel option. These
improvements would provide additional capacity to relieve some of the
projected near- and long-term demand on the highway system, potentially
slowing the need to further expand highways and airports in this
portion of the corridor, or reduce the scale of those expansions,
including their associated cost and impacts on communities and the
environment. Rail improvements would augment the highway system,
creating an interconnected, multimodal solution, allowing for better
mobility throughout the corridor. Improved rail infrastructure would
contribute to the economic viability of the Coast Corridor and provide
connectivity with local transit systems.

Environmental Review Process

    The EIS/EIR will be developed in accordance with the National
Environmental Policy Act of 1969 (NEPA), 42 U.S.C. 4321 and the Council
on Environmental Quality (CEQ) regulations (40 CFR part 1500 et seq.)
implementing NEPA; the California Environmental Quality Act (CEQA),
Division 13, Public Resources Code; and FRA's Procedures for
Considering Environmental Impacts (64 FR 28545; May 26, 1999). FRA and
Caltrans intend to use a tiered process for the completion of the
environmental review of the Coast Corridor, as provided for in 40 CFR
1508.28 and FRA Procedures.
    FRA is considering the option of preparing a Tier 1 EIS/EIS.
``Tiering'' is a staged environmental review process often applied to
environmental reviews for complex transportation projects. If used, the
initial phase of a tiered process will address broad questions and
likely environmental effects for the Salinas to San Luis Obispo portion
of the Coast Corridor including, but not limited to, the type of
service(s) being proposed, major infrastructure components, and
identification of major facility capacity constraints. If tiering is
not used, the EIR/EIS will analyze, at a greater level of detail, site-
specific proposals that would otherwise be addressed in subsequent
phases or tiers based on the decisions made in a Tier 1 EIS/EIR.

Alternatives

    Alternatives to be evaluated and analyzed in the EIS/EIR include a
no-action (No-Project or No-Build) scenario and an action alternative
consisting of multiple options for the construction of various
passenger Coast Corridor improvements between Salinas and San Luis
Obispo. Possible environmental impacts from the action alternative
include displacement of commercial and residential properties;
disproportionate impacts to minority and low-income populations;
community and neighborhood disruption; increased noise and vibration
along the rail corridor; traffic impacts associated with stations;
effects to historic properties or archaeological sites; impacts to
parks and recreation resources; visual quality effects; exposure to
seismic and flood hazards; impacts to water resources, wetlands, and
sensitive biological species and habitat; land use compatibility
impacts; energy use; and impacts to agricultural lands.

No Action Alternative

    The no action alternative is defined to serve as the baseline for
comparison of all alternatives. This alternative represents
California's transportation system (highway, air, and rail) as it
exists, and as it would exist after completion of programs or projects
currently funded or being implemented. The no-action alternative would
draw upon the following sources of information:
    [ssquf] State Transportation Improvement Program (STIP).
    [ssquf] Regional Transportation Plans (RTPs) for all modes of
travel.
    [ssquf] Airport plans.
    [ssquf] Passenger rail plans.

Action Alternative

    This alternative would facilitate expanded passenger service along
the Coast Corridor. The Action Alternative will have ``options''
consisting of logical groupings of improvements that take into account
the likely timing of such improvements and possible funding scenarios.
The improvements to be analyzed in this alternative may include:
    [ssquf] Track upgrades.
    [ssquf] Curve realignments.
    [ssquf] Siding extensions and upgrades.
    [ssquf] Addition of second main track.
    [ssquf] Grade separations.
    [ssquf] New Stations.
    [ssquf] Station and platform upgrades.
    [ssquf] Installation of Centralized Traffic Control (CTC) and power
switches.
    [ssquf] New or upgraded pedestrian crossings.
Scoping and Comments
    FRA encourages broad participation in the EIS/EIR process during
scoping and subsequent review of the resulting environmental document.
Letters soliciting comments were sent to appropriate Federal, State,
and local agencies, and appropriate railroads. Comments and suggestions
are invited from all interested agencies and the public at large to
insure the full range of issues related to the proposed action and all
reasonable alternatives are addressed and all significant issues are
identified. In particular, FRA is interested in determining whether
there are areas of environmental concern where there might be the
potential for significant impacts identifiable at a program level.
Public agencies with jurisdiction are requested to advise the FRA and
Caltrans of the applicable permit and environmental review requirements
of each agency, and the scope and content of the environmental
information that is germane to the agency's statutory responsibilities
in connection with the proposed improvements.

    Issued in Washington, DC, on August 13, 2012.
Corey Hill,
Director, Rail Project Development and Delivery.
[FR Doc. 2012-20245 Filed 8-16-12; 8:45 am]
BILLING CODE 4910-06-P


[Federal Register Volume 83, Number 49 (Tuesday, March 13, 2018)]
[Rules and Regulations]
[Pages 10796-10800]
[FR Doc No: 2018-05057]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 52 and 81

[EPA-R05-OAR-2017-0256; FRL-9975-46-Region 5]

Air Plan Approval; Ohio; Redesignation of the Delta, Ohio Area to
Attainment of the 2008 Lead Standard

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is approving the
State of Ohio's request to redesignate the portion of Fulton County,
Ohio known as the Delta nonattainment area (Delta area) to attainment
of the 2008 National Ambient Air Quality Standards (NAAQS or standard)
for lead. EPA is also approving, as meeting Clean Air Act (CAA)
requirements, the maintenance plan and related elements of the
redesignation, reasonably available control measure (RACM)/reasonably
available control technology (RACT) measures and a comprehensive
emissions inventory. EPA is taking these actions in accordance with the
CAA and EPA's implementation regulations regarding the 2008 lead NAAQS.

DATES: This final rule is effective on March 13, 2018.

ADDRESSES: EPA has established a docket for this action under Docket ID
No. EPA-R05-OAR-2017-0256. All documents in the docket are listed on
the www.regulations.gov website. Although listed in the index, some
information is not publicly available, i.e., Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute. Certain other material, such as copyrighted material, is
not placed on the internet and will be publicly available only in hard
copy form. Publicly available docket materials are available either
through www.regulations.gov or at the Environmental Protection Agency,
Region 5, Air and Radiation Division, 77 West Jackson Boulevard,
Chicago, Illinois 60604. This facility is open from 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding Federal holidays. We recommend
that you telephone Matt Rau, Environmental Engineer at<PHONE_NUMBER>
before visiting the Region 5 office.

FOR FURTHER INFORMATION CONTACT: Matt Rau, Environmental Engineer,
Control Strategies Section, Air Programs Branch (AR-18J), Environmental
Protection

Agency, Region 5, 77 West Jackson Boulevard, Chicago, Illinois 60604,
(312) 886-6524, [email protected].

SUPPLEMENTARY INFORMATION: Throughout this document whenever ``we,''
``us,'' or ``our'' is used, we mean EPA. This supplementary information
section is arranged as follows:

I. What is the background?
II. What are EPA's responses to the comments?
III. What action is EPA taking?
IV. Statutory and Executive Order Reviews
V. Judicial Review

I. What is the background?

    On November 12, 2008 (73 FR 66964), EPA established the 2008
primary and secondary lead NAAQS at 0.15 micrograms per cubic meter
([mu]g/m\3\) based on a maximum arithmetic three-month mean
concentration for a three-year period. 40 CFR 50.16.
    On November 22, 2010 (75 FR 71033), EPA published its initial air
quality designations and classifications for the 2008 lead NAAQS based
upon air quality monitoring data for calendar years 2007-2009. These
designations became effective on December 31, 2010. The Delta area
portion of Fulton County was designated as nonattainment for lead,
specifically portions of Swan Creek and York Townships. 40 CFR 81.336.
On May 26, 2015 (80 FR 29964), EPA issued a Clean Data Determination,
which determined that the Delta area attained the 2008 lead NAAQS prior
to its attainment date of December 31, 2015.
    On April 27, 2017, Ohio requested EPA to redesignate the Delta area
to attainment of the 2008 lead NAAQS and provided documentation in
support of its request. On October 18, 2017 (82 FR 48442), EPA issued a
direct final rule approving Ohio's request to redesignate the Delta
area to attainment. However, since EPA received relevant adverse
comments on this action within the prescribed period, EPA withdrew the
direct final rule. EPA had also proposed to approve the request to
redesignate the Delta area to attainment of the 2008 lead NAAQS on
October 18, 2017 (82 FR 48474). This action is a final rule based on
the October 18, 2017 proposal.
    The requirements for redesignating an area from nonattainment to
attainment are found in CAA section 107 (d)(3)(E). There are five
criteria for redesignating an area. First, the Administrator must
determine that the area has attained the applicable NAAQS based on
current air quality data. Second, the Administrator must have fully
approved the applicable SIP for the area under CAA section 110(k). The
third criterion is for the Administrator to determine that the air
quality improvement is the result of permanent and enforceable emission
reductions. Fourth, the Administrator must have fully approved a
maintenance plan meeting the CAA section 175A requirements. The fifth
criterion is that the state has met all of the applicable requirements
of CAA section 110 and part D.
    The direct final rule published on October 18, 2017 (82 FR 48442)
details how the Delta area has met the requirements for redesignation
under section 107(d)(3)(E) of the CAA. In summary, EPA's approval of
the RACM/RACT measures satisfies section 172 (c)(1) of the CAA. EPA is
approving Ohio's 2013 emissions inventories for the Delta area as
meeting the requirement of section 172(c)(3) of the CAA. EPA finds that
the other requirements of CAA section 172(c) are not applicable because
the Delta area has monitored attainment of the 2008 lead NAAQS.
Further, EPA is approving Ohio's maintenance plan as it adequately
addresses the requirements of section 175A of the CAA.

II. What are EPA's responses to the comments?

    EPA received an anonymous comment on November 16, 2017. The comment
is discussed below along with a response from EPA.
    Comment: The commenter stated, ``In 2009 the areas [sic] design
value for lead was 0.18 and dropped significantly to 0.09 in 2012, but
in 2014 the design value increased significantly back up to 0.12. This
shows that the area hasn't maintained a consistent level that shows
attainment below 0.15.'' The commenter further stated that, ``EPA
shouldn't approve the re-designation request until the Fulton area
shows better improvement in the monitored lead design values. EPA
should wait until the lead levels become steady without increasing.''
The commenter further states, ``EPA needs to take lead violations
seriously.''
    Response: EPA disagrees with the commenter that the variability in
the area's design value prohibits a redesignation to attainment. The
statute does not require an area's design value to ``maintain a
consistent level'' at its lowest recorded value or ``become steady
without increasing,'' but rather requires that the air quality in the
area is attaining the standard. In this case, though there was a
fluctuation in the area's design values. Those values have remained
below the level of the 2008 NAAQS for the relevant period, and,
contrary to commenter's suggestion, has not violated the standard.
Since the Bunting Bearing Company's Delta, Ohio facility (Bunting),
identified by Ohio as the only point source of lead emissions in the
nonattainment area, improved its lead emission controls in 2012 by
adding required inspections, leak detection systems, corrective
actions, and recordkeeping, the area has been consistently attaining
the standard. Those controls are permanent and federally enforceable.
Thus EPA has reasonably determined that, in accordance with the
statute, the area is attaining and that the attainment is due to
permanent and enforceable measures.
    Comment: The commenter also asked, ``what happens if the area's
lead levels increase another 0.03?''
    Response: An increase from the 2014-2016 design value of 0.12
[micro]g/m\3\ to 0.15 [micro]g/m\3\ would mean that the area would
still be in attainment of the 2008 lead NAAQS and public health would
remain protected. More importantly, Ohio's maintenance plan for the
Delta area has contingency measures that help prevent NAAQS violations
and that address violations if they occur. As part of its contingency
measures, the state has committed that a ``warning'' level response is
triggered if the lead concentration reaches 0.135 [micro]g/m\3\ on a
three-month rolling average. If a warning level response is triggered,
Ohio will conduct a study to determine whether the lead values indicate
a trend toward exceeding the standard and what control measures would
be necessary to reverse the trend within 12 months of the conclusion of
the calendar year. An ``action'' level response is triggered if the
lead concentration reaches a level at or above 0.143 [micro]g/m\3\ on a
three-month rolling average. The action level response will require
Ohio to work with the entity found to be responsible for the ambient
concentration to evaluate and implement the needed control measures to
bring the area into attainment within 18 months of the conclusion of
the calendar year that triggered the response. Should the 2008 lead
NAAQS be violated during the maintenance period, Ohio will implement
one or more contingency measures. The contingency measures will be
considered based on the cause of the elevated lead levels. Potential
measures include improvements to existing control devices, the addition
of a secondary control device, and improvements to housekeeping and
maintenance. EPA has determined that the contingency measures are
adequate to promptly correct a violation of the ambient lead NAAQS.

III. What action is EPA taking?

    EPA is approving the request from Ohio to change the legal
designation of

the Delta area from nonattainment to attainment for the 2008 lead
NAAQS. EPA is approving Ohio's maintenance plan for the Delta area as a
revision to the Ohio SIP because we have determined that the plan meets
the requirements of section 175A of the CAA. EPA is approving the
emission controls in Air Pollution Permits-to-Install and Operate
P0108083, P0121822, P0120836, and P0121942 all issued to Bunting as
meeting the RACM/RACT requirements of CAA section 172(c)(1).
    Specifically, EPA is approving the necessary elements from the
permits, emission limits and Preventive Maintenance Plan conditions,
into the Ohio SIP rather than the entirety of the permits. The emission
limits are for units controlled with Baghouse A: 0.150 pounds per hour
combined limit, Baghouse B: 0.150 pounds per hour combined limit, and
Baghouse C: 0.075 pounds per hour combined limit. The approved specific
required elements of the Preventive Maintenance Plan are detailed on
pages 24 to 26 of Ohio's ``Redesignation Request and Maintenance Plan
for the Partial Fulton County, OH Annual Lead Nonattainment Area,''
submitted in April 2017. In summary, the required elements are five
elements of inspections, three elements of fabric filter leak detection
systems, three elements of corrective actions, and five elements of
records.
    EPA is approving the 2013 emissions inventory as meeting the
comprehensive emissions inventory requirements of section 172(c)(3) of
the CAA. EPA is taking these actions in accordance with the CAA and
EPA's implementation regulations regarding the 2008 lead NAAQS.
    In accordance with 5 U.S.C. 553(d), EPA finds there is good cause
for these actions to become effective immediately upon publication.
This is because a delayed effective date is unnecessary due to the
nature of a redesignation to attainment, which relieves the area from
certain CAA requirements that would otherwise apply to it. The
immediate effective date for this action is authorized under both 5
U.S.C. 553(d)(1), which provides that rulemaking actions may become
effective less than 30 days after publication if the rule ``grants or
recognizes an exemption or relieves a restriction,'' and section
553(d)(3), which allows an effective date less than 30 days after
publication ``as otherwise provided by the agency for good cause found
and published with the rule.'' The purpose of the 30-day waiting period
prescribed in section 553(d) is to give affected parties a reasonable
time to adjust their behavior and prepare before the final rule takes
effect. This rule, however, does not create any new regulatory
requirements such that affected parties would need time to prepare
before the rule takes effect. Rather, this rule relieves the state of
planning requirements for this lead nonattainment area. For these
reasons, EPA finds good cause under 5 U.S.C. 553(d)(1) and (3) for
these actions to become effective on the date of publication of these
actions.

IV. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the CAA and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely approves state law as meeting Federal requirements and
does not impose additional requirements beyond those imposed by state
law. For that reason, this action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     Is not an Executive Order 13771 (82 FR 9339, February 2,
2017) regulatory action because SIP approvals are exempted under
Executive Order 12866;
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, the SIP is not approved to apply on any Indian
reservation land or in any other area where EPA or an Indian tribe has
demonstrated that a tribe has jurisdiction. In those areas of Indian
country, the rule does not have tribal implications and will not impose
substantial direct costs on tribal governments or preempt tribal law as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).

V. Judicial Review

    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by May 14, 2018. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed, and shall not postpone the effectiveness of such rule or
action. This action may not be challenged later in proceedings to
enforce its requirements. (See section 307(b)(2)).

List of Subjects

40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Lead, Reporting and
recordkeeping requirements.

40 CFR Part 81

    Environmental protection, Administrative practice and procedure,
Air pollution control, Designations and classifications,
Intergovernmental relations, Lead, Reporting and recordkeeping
requirements.

    Dated: February 27, 2018.
Cathy Stepp,
Regional Administrator, Region 5.

    40 CFR parts 52 and 81 are amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for part 52 continues to read as follows:

    Authority: 42 U.S.C. 7401 et seq.

0
2. In Sec.  52.1870, the table in paragraph (e) is amended by adding
the entry ``Lead (2008)'' after the entry ``Lead (2008)'' (with the
State date of 6/29/2016) to read as follows:

Sec.  52.1870  Identification of plan.

* * * * *
    (e) * * *

                         EPA-Approved Ohio Nonregulatory and Quasi-Regulatory Provisions
----------------------------------------------------------------------------------------------------------------
                                  Applicable
           Title             geographical or non-    State date        EPA approval             Comments
                                attainment area
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                                 Summary of Criteria Pollutant Maintenance Plan
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Lead (2008)................  Delta (partial             4/27/2017  3/13/2018, [insert   Includes approval of the
                              Fulton County).                       Federal Register     2013 lead base year
                                                                    citation].           emissions inventory and
                                                                                Preventative
                                                                                Maintenance Plan as
                                                                                RACM/RACT for the
                                                                                Bunting Bearing LLC
                                                                                Delta facility.

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

0
3. Section 52.1893 is amended by adding paragraphs (f), (g), and (h) to
read as follows:

Sec.  52.1893  Control strategy: Lead (Pb).

* * * * *
    (f) Ohio's 2013 lead emissions inventory for the Delta area,
submitted on April 27, 2017, to meet the emission inventory
requirements of section 172(c)(3) of the Clean Air Act for the Delta
area.
    (g) Approval--The 2008 lead maintenance plan for the Delta, Ohio
nonattainment area, submitted on April 27, 2017.
    (h) Existing controls and maintenance provisions in the Air
Pollution Permits-to-Install and Operate P0108083, P0121822, P0120836,
and P0121942 for the Bunting Bearing LLC Delta facility including the
preventative maintenance plan as fulfilling the RACM/RACT 172(c)(1)
requirement. Permits P0120836, P0121822, and P0121942, all issued
February 28, 2017, require a combined limit of 0.150 pounds lead per
hour for units P006 to P011, P013, P020 to P025, P029 to P032, P035,
and P036. Permit P0108083, issued October 29, 2012, requires a combined
limit of 0.150 pounds lead per hour for units P014 to P019 and P028 and
a combined limit of 0.075 pounds lead per hour for unit P005.

PART 81--DESIGNATION OF AREAS FOR AIR QUALITY PLANNING PURPOSES

0
4. The authority citation for part 81 continues to read as follows:

    Authority: 42 U.S.C. 7401, et seq.

0
5. Section 81.336 is amended by revising the entry ``Delta, OH:'' in
the table entitled ``Ohio--2008 Lead NAAQS'' to read as follows:

Sec.  81.336  Ohio.

* * * * *

                          Ohio--2008 Lead NAAQS
------------------------------------------------------------------------
                                    Designation for the 2008 NAAQS \a\
         Designated area         ---------------------------------------
                                     Date \1\              Type
------------------------------------------------------------------------

                              * * * * * * *
Delta, OH:                             3/13/2018  Attainment.
    Fulton County (part)........
        The portions of Fulton
         County that are bounded
         by: sections 12 and 13
         of York Township and
         sections 7 and 18 of
         Swan Creek Township.

                              * * * * * * *
------------------------------------------------------------------------
\a\ Includes Indian Country located in each county or area, except as
  otherwise specified.
\1\ December 31, 2011 unless otherwise noted.

[FR Doc. 2018-05057 Filed 3-12-18; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 77, Number 49 (Tuesday, March 13, 2012)]
[Notices]
[Pages 14810-14811]
[FR Doc No: 2012-6039]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-P-0527]

Determination That DURANEST (Etidocaine Hydrochloride) Injection,
0.5%, and Five Other DURANEST Drug Products Were Not Withdrawn From
Sale for Reasons of Safety or Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) has determined that the
DURANEST (etidocaine hydrochloride) drug products listed in this
document were not withdrawn from sale for reasons of safety or
effectiveness. This determination will allow FDA to approve abbreviated
new drug applications (ANDAs) that refer to these drug products if all
other legal and regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: Rachel Bressler, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6302, Silver Spring, MD 20993-0002, 301-
796-4288.

SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products under an ANDA procedure. ANDA applicants
must, with certain exceptions, show that the drug for which they are
seeking approval contains the same active ingredient in the same
strength and dosage form as the ``listed drug,'' which is a version of
the drug that was previously approved. ANDA applicants do not have to
repeat the extensive clinical testing otherwise necessary to gain
approval of a new drug application (NDA). The only clinical data
required in an ANDA are data to show that the drug that is the subject
of the ANDA is bioequivalent to the listed drug.
    The 1984 amendments include what is now section 505(j)(7) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which
requires FDA to publish a list of all approved drugs. FDA publishes
this list as part of the ``Approved Drug Products With Therapeutic
Equivalence Evaluations,'' which is known generally as the ``Orange
Book.'' Under FDA regulations, drugs are removed from the list if the
Agency withdraws or suspends approval of the drug's NDA or ANDA for
reasons of safety or effectiveness or if FDA determines that the listed
drug was withdrawn from sale for reasons of safety or effectiveness (21
CFR 314.162).
    A person may petition the Agency to determine, or the Agency may
determine on its own initiative, whether a listed drug was withdrawn
from sale for reasons of safety or effectiveness. This determination
may be made at any time after the drug has been withdrawn from sale,
but must be made prior to approving an ANDA that refers to the listed
drug (Sec.  314.161 (21 CFR 314.161)). FDA may not approve an ANDA that
does not refer to a listed drug.
    The drug products listed in the table in this document are no
longer being marketed. DURANEST is indicated for infiltration
anesthesia, peripheral nerve blocks (e.g., brachial plexus, intercostal
retrobular, ulnar, inferior alveolar), and central nerve block (i.e.,
lumbar or caudal epidural blocks).

------------------------------------------------------------------------
                                                      Initial approval
 Application No.        Drug          Applicant             date
------------------------------------------------------------------------
NDA 17-751......  DURANEST         AstraZeneca      August 30, 1976.
                   (epinephrine     Pharmaceutical.
                   bitartrate;
                   etidocaine
                   hydrochloride)
                   Injection 1%.

Do..............  DURANEST         ......do.......   Do.
                   (epinephrine
                   bitartrate;
                   etidocaine
                   hydrochloride)
                   Injection 1.5%.
Do..............  DURANEST         ......do.......   Do.
                   (epinephrine;
                   etidocaine
                   hydrochloride)
                   Injection 0.5%.
Do..............  DURANEST         ......do.......   Do.
                   (etidocaine
                   hydrochloride)
                   Injection 0.5%.
Do..............  DURANEST         ......do.......   Do.
                   (etidocaine
                   hydrochloride)
                   Injection 1%.
NDA 21-384......  DURANEST         DENTSPLY          Do.
                   (epinephrine     Pharmaceutical.
                   bitartrate;
                   etidocaine
                   hydrochloride)
                   Injection 1.5%.
------------------------------------------------------------------------

    The drug products listed in the table in this document are
currently listed in the ``Discontinued Drug Product List'' section of
the Orange Book. Lachman Consultant Services, Inc. submitted a citizen
petition dated September 25, 2008 (Docket No. FDA-2008-P-0527), under
21 CFR 10.30, requesting that the Agency determine whether DURANEST
(etidocaine hydrochloride) Injection, 0.5% and 1%, were withdrawn from
sale for reasons of safety or effectiveness. Although the citizen
petition did not request a determination for the other DURANEST drug
products listed in the table in this document, those drug products have
also been discontinued. On our own initiative, we have also determined
whether those products were withdrawn for safety or effectiveness
reasons.
    After considering the citizen petition and reviewing Agency records
and based on the information we have at this time, FDA has determined
under Sec.  314.161 that the DURANEST drug products listed in the table
in this document were not withdrawn for reasons of safety or
effectiveness. The petitioner has identified no data or other
information suggesting that the DURANEST drug products were withdrawn
for reasons of safety or effectiveness. We have carefully reviewed our
files for records concerning the withdrawal of the DURANEST drug
products from sale. We have also independently evaluated relevant
literature and data for possible postmarketing adverse events. We have
reviewed the available evidence and determined that the products were
not withdrawn from sale for reasons of safety or effectiveness.
Accordingly, the Agency will continue to list the DURANEST drug
products listed in the ``Discontinued Drug Product List'' section of
the Orange Book. The ``Discontinued Drug Product List'' delineates,
among other items, drug products that have been discontinued from
marketing for reasons other than safety or effectiveness. ANDAs that
refer to any of the DURANEST drug products listed in the table in this
document may be approved by the Agency as long as they meet all other
legal and regulatory requirements for the approval of ANDAs. If FDA
determines that labeling for these drug products should be revised to
meet current standards, the Agency will advise ANDA applicants to
submit such labeling.

    Dated: March 8, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-6039 Filed 3-12-12; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 88, Number 127 (Wednesday, July 5, 2023)]
[Notices]
[Page 42933]
[FR Doc No: 2023-14191]

=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OLEM-2022-0967; FRL-10938-01-OLEM]

Variances From the Classification of Solid Waste for HVF Precious
Metals, LLC (Tucson, AZ)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of final decision.

-----------------------------------------------------------------------

SUMMARY: The Environmental Protection Agency (EPA) is granting a
petition for variances from the classification as solid waste for two
materials produced by HVF Precious Metals, LLC (HVF) at its facility in
Tucson, Arizona.

DATES: Date of publication is July 5, 2023.

FOR FURTHER INFORMATION CONTACT: For further information regarding the
Federal Register notice, contact Phoebe O'Connor, Office of Resource
Conservation and Recovery, Office of Land and Emergency Management,
(5304T), U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue
NW, Washington, DC 20460; telephone number:<PHONE_NUMBER>; email
address: [email protected].
    For further information regarding the incoming petition, Statement
of Basis, and any technical questions, contact Sharon Lin, RCRA Branch;
Land, Chemicals, and Redevelopment Division, U.S. Environmental
Protection Agency Region 9, 75 Hawthorne Street, (Mail code LND-4-2),
San Francisco, CA 94105; telephone number:<PHONE_NUMBER>; email
address: [email protected].

SUPPLEMENTARY INFORMATION:

Background

    Section 260.30(c) allows the EPA Administrator to determine on a
case-by-case basis that materials that have been reclaimed but must be
further reclaimed before the materials are fully recovered are not
solid wastes. The effect of a variance from the classification of solid
waste is to exempt the material from RCRA hazardous waste regulations.
The EPA, after providing for notice and comment (see 88 FR 9277), is
finalizing its response to a petition submitted by HVF on July 26, 2022
(HVF's Petition). HVF's Petition concerns two partially-reclaimed
materials (``Solution Sweeps'' and ``Filter Sweeps'') produced at its
Tucson, Arizona facility from precious metal-bearing waste from
cyanide-based electroplating operations. As explained in the
``Statement of Basis'' available in the docket [Docket ID EPA-HQ-OLEM-
2022-0967-0008], EPA's determination is that the two materials produced
by HVF are ``commodity-like'' under the criteria listed in Sec.
260.31(c) and are legitimately recycled, thus qualifying for variances
from classification as solid waste under Sec.  260.30(c). The EPA
published a proposed response to the petition on February 13, 2023 (88
FR 9277). The comment period for the proposed action closed on March
30, 2023. The EPA did not receive any comments on the proposed action
during the public comment period and is therefore finalizing the
variance as proposed.
    For information on the EPA's rationale for granting the petition,
see the ``Statement of Basis'' available in the docket [Docket ID EPA-
HQ-OLEM-2022-0967-0008]. EPA had previously provided a proposed
``Statement of Basis'' in the docket for the proposed variance
determination [Docket ID EPA-HQ-OLEM-2022-0967-0002], and now, with
this final variance determination, published in the July 5, 2023
Federal Register, EPA is also providing a final ``Statement of Basis''
in the docket for the final variance determination.

Michael S. Regan,
Administrator.
[FR Doc. 2023-14191 Filed 7-3-23; 8:45 am]
BILLING CODE 6560-50-P