[Federal Register Volume 87, Number 52 (Thursday, March 17, 2022)]
[Notices]
[Pages 15237-15240]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-05656]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2022-0132; FRL-9411-04-OSCPP]


Certain New Chemicals; Receipt and Status Information for 
February 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

[[Page 15238]]

concluded review. This document covers the period from 02/01/2022 to 
02/28/2022.

DATES: Comments identified by the specific case number provided in this 
document must be received on or before April 18, 2022.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2022-0132, and the specific case number for the 
chemical substance related to your comment, 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 or visiting the docket, along 
with more information about dockets generally, is available at https://www.epa.gov/dockets.
    Due to the public health concerns related to COVID-19, the EPA 
Docket Center (EPA/DC) and Reading Room is closed to visitors with 
limited exceptions. The staff continues to provide remote customer 
service via email, phone, and webform. For the latest status 
information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: 
    For technical information contact: Jim Rahai, Project Management 
and Operations Division (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

What action is the Agency taking?

    This document provides the receipt and status reports for the 
period from 02/01/2022 to 02/28/2022. 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: 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: http://www.epa.gov/oppt/newchems.
    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 http://www.epa.gov/dockets/comments.html.

I. 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

[[Page 15239]]

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 02/01/2022 to 02/28/2022
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                                    Received
       Case No.         Version       date        Manufacturer              Use             Chemical substance
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J-22-0008A...........          3   02/15/2022  CBI..............  (G) Manufacture of an   (G) Modified Yeast.
                                                                   alcohol.
J-22-0011A...........          2   01/28/2022  CBI..............  (G) Ethanol production  (G) Biofuel producing
                                                                                           Saccharomyces
                                                                                           cerevisiae modified,
                                                                                           genetically stable.
P-16-0218A...........          7   02/03/2022  CBI..............  (G) Reactant: Spray     (G) Acetoacetylated
                                                                   Foam Insulation,        Glycerin.
                                                                   Architectural Coating.
P-20-0124A...........          4   02/18/2022  CBI..............  (G) Additive in         (S) 5-octen-4-ol, 3,5-
                                                                   Household consumer      dimethyl-, (5E)-.
                                                                   products.
P-20-0126A...........          4   02/18/2022  CBI..............  (G) Additive in         (S) 4-Decenal, 5,9-
                                                                   household consumer      dimethyl-.
                                                                   products.
P-21-0011A...........          3   02/01/2022  CBI..............  (S) Crosslinking agent  (G) Hexane, 1,6-
                                                                   for inks and coatings.  diisocyanato-,
                                                                                           homopolymer, alkyl
                                                                                           epoxy ether- and
                                                                                           polyethylene glycol
                                                                                           mono-Me ether-
                                                                                           blocked, reaction
                                                                                           products with
                                                                                           propylenimine.
P-21-0082A...........          2   02/18/2022  CBI..............  (G) Additive in         (S) 1-Decen-4-yne.
                                                                   household consumer
                                                                   products.
P-21-0205A...........          2   02/18/2022  CBI..............  (G) Additive in         (S) Benzene, [2-[(2-
                                                                   household consumer      methyl-1-undecen-1-
                                                                   products.               yl{time} oxy]ethyl]-.
P-21-0206A...........          3   02/18/2022  HollyFrontier      (G) Component of        (G) Alkanes, branched
                                                Corporation.       gasoline.               and linear.
P-22-0017A...........          2   02/01/2022  Sasol Chemicals    (S) Paraffin wax        (S) 1-Eicosanol,
                                                (USA), LLC.        substitute for          manuf. of, distn.,
                                                                   candles, Alkylate for   residues.
                                                                   polymer esters.
P-22-0036............          2   02/07/2022  Torrecid USA, LLC  (S) coloring agent,     (S) chromium iron
                                                                   pigment for master      manganese oxide.
                                                                   batch.
P-22-0037............          1   02/03/2022  Allnex USA, Inc..  (S) Additol XL 186 is   (G) Polyphosphoric
                                                                   a specific, high        acids, esters with
                                                                   efficiency additive     heteromonocycle
                                                                   which improves the      homopolymer.
                                                                   adhesion to metal,
                                                                   especially under
                                                                   humid conditions.
P-22-0039............          2   02/25/2022  CBI..............  (S) Colorant for        (G) Poly(oxy-1,2-
                                                                   agricultural            ethanediyl),alpha,alp
                                                                   applications.           ha'-[[[4-(4-alkyl
                                                                                           heteroaryl)ene]aryl]i
                                                                                           mino]di-2,1-
                                                                                           ethanediyl]bis[omega-
                                                                                           hydroxy-].
P-22-0040............          1   02/07/2022  CBI..............  (G) Component used in   (S) Manganate(4-),
                                                                   manufacture of high     hexakis(cyano-
                                                                   performance batteries.  .kappa.C)-, manganese
                                                                                           (2+) sodium, (OC-6-
                                                                                           11)-.
P-22-0041............          1   02/07/2022  CBI..............  (G) A component used    (S) Ferrate (-4),
                                                                   in the manufacture of   hexakis(cyano-
                                                                   batteries.              .kappa.C)-, iron(3+)
                                                                                           manganese(2+) sodium,
                                                                                           (OC-6-11)-.
P-22-0042............          1   02/09/2022  CBI..............  (G) Photolithography..  (G) Alkanedione,
                                                                                           [[[(substituted)aryl]
                                                                                           thio]aryl]-, 2-(O-
                                                                                           acetyloxime).
P-22-0044............          1   02/15/2022  CBI..............  (G) Site Limited        (G) Silica gel,
                                                                   Intermediate.           reaction products
                                                                                           with alkyl metal
                                                                                           salt.
P-22-0045............          1   02/15/2022  AkzoNobel........  (G) Polymer used in     (G) Fatty acids,
                                                                   the manufacture of      polymer with modified
                                                                   paint.                  benzofuran-1,3-dione,
                                                                                           pentaerythritol and
                                                                                           aromatic acid
                                                                                           anhydride.
P-22-0047............          2   02/25/2022  CBI..............  (G) Epoxy additive....  (G) Alkyl substituted
                                                                                           carbopolycyclic acids
                                                                                           and heteromonocyclic
                                                                                           esters.
P-22-0048............          2   02/24/2022  Ashland, Inc.....  (S) Intermediate in     (G) halogenated
                                                                   film.                   dodecyl-acetylen.
SN-22-0001A..........          2   01/28/2022  CBI..............  (G) Component in        (S) Ethanol, 2,2',2''-
                                                                   polishing formulation.  nitrilotris-, compd.
                                                                                           with .alpha.-[2,4,6-
                                                                                           tris(1-
                                                                                           phenylethyl)phenyl]-
                                                                                           .omega.-
                                                                                           hydroxypoly(oxy-1,2-
                                                                                           ethanediyl)
                                                                                           phosphate.
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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.


[[Page 15240]]

    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 02/01/2022 to 02/28/2022
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                                                                   If amendment,
           Case No.              Received date    Commencement        type of            Chemical substance
                                                      date           amendment
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J-22-0001.....................      02/22/2022        02/15/2022               N   (G) Chromosomally-modified
                                                                                    saccharomyces cerevisiae.
J-22-0002.....................      02/22/2022        01/31/2022               N   (G) Chromosomally-modified
                                                                                    saccharomyces cerevisiae.
P-15-0694.....................      02/24/2022        02/21/2022               N   (S) Phenol, polymer with
                                                                                    formaldehyde, glycidyl
                                                                                    ether, polymers with 1,3-
                                                                                    benzenedimethanamine,
                                                                                    reaction products with 2-
                                                                                    [(c12-14-
                                                                                    alkyloxy)methyl]oxirane.
P-17-0198.....................      02/22/2022        02/07/2022               N   (S) Neodymium, chloro et
                                                                                    hydro iso-bu neodecanoate
                                                                                    polybutadiene aluminum
                                                                                    complexes.
P-18-0170.....................      02/23/2022        02/23/2022               N   (S) 1-propanaminium, n,n'-
                                                                                    (oxydi-2,1-ethanediyl)bis[3-
                                                                                    chloro-2-hydroxy-n,n-
                                                                                    dimethyl-, dichloride.
P-19-0010.....................      01/31/2022        01/27/2022               N   (G) Hydrogenated fatty acid
                                                                                    dimers, polymers with 1,1'-
                                                                                    methylenebis[4-
                                                                                    isocyanatobenzene],
                                                                                    polypropylene glycol,
                                                                                    polypropylene glycol ether
                                                                                    with trimethylolpropane
                                                                                    (3:1), and 1,3-propanediol,
                                                                                    propylene glycol
                                                                                    monomethacrylate-blocked.
P-19-0052.....................      02/03/2022        06/03/2020               N   (S) Poly(oxy-1,2-ethanediyl),
                                                                                    alpha-nonyl-omega-hydroxy-,
                                                                                    branched and linear.
P-19-0158.....................      02/15/2022        02/08/2022               N   (G) Alkenoic acid polymer
                                                                                    with 2-ethyl-2-
                                                                                    (hdroxymethyl)-1,3-
                                                                                    alkyldiol, 1,1'-
                                                                                    methylenebis(4-
                                                                                    isocyantocarbomonocycle) and
                                                                                    3-methyl-1,5-aklydiol.
P-21-0005.....................      02/11/2022        01/20/2022               N   (G) Carbonmonocyclic alkene
                                                                                    polymer with alkyl
                                                                                    alkenoate, alkyl alkenoate,
                                                                                    alkyl alkenoate and
                                                                                    polyalkyldiene alkenoate.
P-21-0094.....................      02/08/2022        01/22/2022               N   (G) Silane, halogenated.
P-21-0135.....................      02/09/2022        02/06/2022               N   (G) Alkenoic acid, allyl-,
                                                                                    (dialkylamino)alkyl ester,
                                                                                    polymer with dialkyl-
                                                                                    alkylene-
                                                                                    alkanediyl)bis[carbomoncycle
                                                                                    ], alkylalkyl alkyl-
                                                                                    alkenoate and alkanediol
                                                                                    mono(2-alkyl-alkenoate),
                                                                                    diazenediyl)bis[2-
                                                                                    alkylalkanenitrile]-
                                                                                    initiated.
P-21-0186.....................      02/09/2022        01/18/2022               N   (G) Glycerin, alkoxylated
                                                                                    alkyl acid esters.
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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.

    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 02/01/2022 to 02/28/2022
------------------------------------------------------------------------
                                         Type of test        Chemical
       Case No.         Received date     information       substance
------------------------------------------------------------------------
J-21-0020............      02/09/2022  Complete vector   (G) Sulfolobus
                                        sequence with     solfataricus-
                                        annotations in    strain cb1.
                                        FASTA format.
P-13-0021............      02/23/2022  Hexafor 6240      (G)
                                        polymer method    Perfluoroacryl
                                        validation of     ate polymer.
                                        TOP assay.
P-16-0289............      02/17/2022  Particle size     (G) Benzene
                                        distribution      dicarboxylic
                                        analysis.         acid, polymer
                                                          with alkane
                                                          dioic acid and
                                                          aliphatic
                                                          diamine.
P-16-0543............      02/16/2022  Exposure          (G)
                                        monitoring        Halogenophosph
                                        report.           oric acid
                                                          metal salt.
P-21-0176............      02/23/2022  Skin              (G) Alkane
                                        Sensitization     dioic acid,
                                        (OECD Test        bis (poly
                                        Guideline 406).   aromatic
                                                          triazine)
                                                          alkanoic ether
                                                          phenoxy ester.
------------------------------------------------------------------------

    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: March 14, 2022.
Pamela Myrick,
Director, Project Management and Operations Division, Office of 
Pollution Prevention and Toxics.
[FR Doc. 2022-05656 Filed 3-16-22; 8:45 am]
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