[Federal Register Volume 88, Number 118 (Wednesday, June 21, 2023)]
[Notices]
[Pages 40257-40261]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-13165]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2023-0061; FRL-10581-05-OCSPP]


Certain New Chemicals; Receipt and Status Information for May 
2023

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: EPA is required under the Toxic Substances Control Act (TSCA), 
as amended by the Frank R. Lautenberg Chemical Safety for the 21st 
Century Act, to make information publicly available and to publish 
information in the Federal Register pertaining to submissions under 
TSCA section 5, including notice of receipt of a Premanufacture notice 
(PMN), Significant New Use Notice (SNUN) or Microbial Commercial 
Activity Notice (MCAN), including an amended notice or test 
information; an exemption application (Biotech exemption); an 
application for a test marketing exemption (TME), both pending and/or 
concluded; a notice of commencement (NOC) of manufacture (including 
import) for new chemical substances; and a periodic status report on 
new chemical substances that are currently under EPA review or have 
recently concluded review. This document covers the period from 5/1/
2023 to 5/31/2023.

DATES: Comments identified by the specific case number provided in this 
document must be received on or before July 21, 2023.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2023-0061, through the Federal eRulemaking 
Portal at 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/dockets.

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 5/01/2023 to 5/31/2023. The Agency is providing notice of 
receipt of PMNs, SNUNs, and MCANs (including amended notices and test 
information); an exemption application under 40 CFR part 725 (Biotech 
exemption); TMEs, both pending and/or concluded; NOCs to manufacture a 
new chemical substance; and a periodic status report on new chemical 
substances that are currently under EPA review or have recently 
concluded review.
    EPA is also providing information on its website about cases 
reviewed under the amended TSCA, including the section 5 PMN/SNUN/MCAN 
and exemption notices received, the date of receipt, the final EPA 
determination on the notice, and the effective date of EPA's 
determination for PMN/SNUN/

[[Page 40258]]

MCAN notices on its website at: 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 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'' (i.e., P-18-1234A). The version column designates 
submissions in sequence as ``1'', ``2'', ``3'', etc. Note that in some 
cases, an initial submission is not numbered as version 1; this is 
because earlier version(s) were rejected as incomplete or invalid 
submissions. Note also that future versions of the following tables may 
adjust slightly as the Agency works to automate population of the data 
in the tables.

[[Page 40259]]



                        Table I--PMN/SNUN/MCANs Approved * From 05/01/2023 to 05/31/2023
----------------------------------------------------------------------------------------------------------------
                                 Received
      Case No.        Version      date        Manufacturer               Use               Chemical substance
----------------------------------------------------------------------------------------------------------------
P-21-0168A.........         4   05/10/2023  CBI...............  (G) Colorant...........  (G) Metal,
                                                                                          [heteropolycyclic]-,
                                                                                          [[[(hydroxyalkyl)amino
                                                                                          ]sulfonyl]alkyl]sulfon
                                                                                          yl(sulfoalkyl)sulfonyl
                                                                                          derivs., ammonium
                                                                                          sodium salts.
P-22-0014A.........         5   05/03/2023  Colonial Chemical,  (G) Precursor..........  (G) Sodium
                                             Inc.                                         bis(chloropropanediol)
                                                                                          phosphate.
P-22-0053A.........         4   05/11/2023  CBI...............  (G) Additive in          (S) Ethanol, 2-amino-,
                                                                 agricultural             compds. with
                                                                 formulations.            polyethylene glycol
                                                                                          hydrogen sulfate C10-
                                                                                          16-alkyl ether.
P-22-0078A.........         5   05/09/2023  CBI...............  (S) Dispersing agent     (G) Oxirane, 2-methyl-,
                                                                 for pesticide            polymer with oxirane,
                                                                 formulators.             mono-isoalkyl ethers,
                                                                                          phosphates, salt.
P-22-0095A.........         4   05/05/2023  Locus Fermentation  (G) Surfactant for       (G) Glycolipids,
                                             Solutions.          commercial,              sophorose-contg.,
                                                                 industrial, consumer     yeast-fermented, from
                                                                 applications.            glycerides and
                                                                                          carbohydrates.
P-22-0096A.........         4   05/05/2023  Locus Fermentation  (G) Surfactant for       (G) Glycolipids,
                                             Solutions.          commercial,              sophorose-contg.,
                                                                 industrial, consumer     yeast-fermented, from
                                                                 applications.            glycerides and
                                                                                          carbohydrates.
P-22-0097A.........         4   05/05/2023  Locus Fermentation  (G) Surfactant for       (G) Glycolipids,
                                             Solutions.          commercial,              sophorose-contg.,
                                                                 industrial, consumer     yeast-fermented, from
                                                                 applications.            glycerides and
                                                                                          carbohydrates.
P-22-0098A.........         4   05/05/2023  Locus Fermentation  (G) Surfactant for       (G) Glycolipids,
                                             Solutions.          commercial,              sophorose-contg.,
                                                                 industrial, consumer     yeast-fermented, from
                                                                 applications.            glycerides and
                                                                                          carbohydrates.
P-22-0099A.........         4   05/05/2023  Locus Fermentation  (G) Surfactant for       (G) Glycolipids,
                                             Solutions.          commercial,              sophorose-contg.,
                                                                 industrial, consumer     yeast-fermented, from
                                                                 applications.            glycerides and
                                                                                          carbohydrates.
P-22-0100A.........         4   05/05/2023  Locus Fermentation  (G) Surfactant for       (G) Glycolipids,
                                             Solutions.          commercial,              sophorose-contg.,
                                                                 industrial, consumer     yeast-fermented, from
                                                                 applications.            glycerides and
                                                                                          carbohydrates.
P-22-0130A.........         4   05/17/2023  Integrity Bio-      (S) Surfactant--surface  (S) Maltodextrin,
                                             chemical, LLC.      tension reducing agent   octanoate.
                                                                 for use in production
                                                                 enhancement in oil
                                                                 wells (industrial),
                                                                 emulsifier, surface
                                                                 reduction household
                                                                 and industrial
                                                                 detergents,
                                                                 emulsifier, wetting
                                                                 agent personal care,
                                                                 cosmetic, and pet care
                                                                 grooming products,
                                                                 wetting agent--
                                                                 agriculture,
                                                                 surfactants--as raw
                                                                 materials for use in
                                                                 the manufacture of
                                                                 industrial products
                                                                 and consumer and
                                                                 household products.
P-22-0131A.........         4   05/17/2023  Integrity Bio-      (S) Surfactant--surface  (S) Maltodextrin,
                                             chemical, LLC.      tension reducing agent   hexadecanoate.
                                                                 for use in production
                                                                 enhancement in oil
                                                                 wells (industrial),
                                                                 emulsifier, surface
                                                                 reduction household
                                                                 and industrial
                                                                 detergents,
                                                                 emulsifier, wetting
                                                                 agent personal care,
                                                                 cosmetic, and pet care
                                                                 grooming products,
                                                                 wetting agent--
                                                                 agriculture,
                                                                 surfactants--as raw
                                                                 materials for use in
                                                                 the manufacture of
                                                                 industrial products
                                                                 and consumer and
                                                                 household products.
P-22-0132A.........         4   05/17/2023  Integrity Bio-      (S) Surfactant--surface  (S) Maltodextrin,
                                             chemical, LLC.      tension reducing agent   decanoate.
                                                                 for use in production
                                                                 enhancement in oil
                                                                 wells (industrial),
                                                                 emulsifier, surface
                                                                 reduction household
                                                                 and industrial
                                                                 detergents,
                                                                 emulsifier, wetting
                                                                 agent personal care,
                                                                 cosmetic, and pet care
                                                                 grooming products,
                                                                 wetting agent--
                                                                 agriculture,
                                                                 surfactants--as raw
                                                                 materials for use in
                                                                 the manufacture of
                                                                 industrial products
                                                                 and consumer and
                                                                 household products.

[[Page 40260]]

 
P-22-0133A.........         4   05/17/2023  Integrity Bio-      (S) Surfactant--surface  (S) Maltodextrin,
                                             chemical, LLC.      tension reducing agent   octadecanoate.
                                                                 for use in production
                                                                 enhancement in oil
                                                                 wells (industrial),
                                                                 emulsifier, surface
                                                                 reduction household
                                                                 and industrial
                                                                 detergents,
                                                                 emulsifier, wetting
                                                                 agent personal care,
                                                                 cosmetic, and pet care
                                                                 grooming products,
                                                                 wetting agent--
                                                                 agriculture,
                                                                 surfactants--as raw
                                                                 materials for use in
                                                                 the manufacture of
                                                                 industrial products
                                                                 and consumer and
                                                                 household products.
P-22-0134A.........         4   05/17/2023  Integrity Bio-      (S) Surfactant--surface  (S) Maltodextrin,
                                             chemical, LLC.      tension reducing agent   dodecanoate.
                                                                 for use in production
                                                                 enhancement in oil
                                                                 wells (industrial),
                                                                 emulsifier, surface
                                                                 reduction household
                                                                 and industrial
                                                                 detergents,
                                                                 emulsifier, wetting
                                                                 agent personal care,
                                                                 cosmetic, and pet care
                                                                 grooming products,
                                                                 wetting agent--
                                                                 agriculture,
                                                                 surfactants--as raw
                                                                 materials for use in
                                                                 the manufacture of
                                                                 industrial products
                                                                 and consumer and
                                                                 household products.
P-22-0135A.........         4   05/17/2023  Integrity Bio-      (S) Surfactant--surface  (S) Maltodextrin,
                                             chemical, LLC.      tension reducing agent   tetradecanoate.
                                                                 for use in production
                                                                 enhancement in oil
                                                                 wells (industrial),
                                                                 emulsifier, surface
                                                                 reduction, household
                                                                 and industrial
                                                                 detergents,
                                                                 emulsifier, wetting
                                                                 agent personal care,
                                                                 cosmetic, and pet care
                                                                 grooming products,
                                                                 wetting agent--
                                                                 agriculture,
                                                                 surfactants--as raw
                                                                 materials for use in
                                                                 the manufacture of
                                                                 industrial products
                                                                 and consumer and
                                                                 household products.
P-22-0151A.........         5   05/08/2023  CBI...............  (G) Surfactant for       (G) Glycolipids,
                                                                 commercial               sophorose-contg.,
                                                                 applications.            yeast-fermented, from
                                                                                          glycerides and
                                                                                          carbohydrates.
P-23-0070A.........         3   05/04/2023  CBI...............  (G) Surfactant for       (S) Fatty Acids, C8-14,
                                                                 cleaning products, pet   methyl-2-sulfoethyl
                                                                 shampoo, hand            esters, sodium salts.
                                                                 cleansing, laundry,
                                                                 and dishwasher
                                                                 detergent.
P-23-0079..........         4   05/09/2023  Lawter............  (G) Non-reactive resin   (S) rosin, maleated,
                                                                 to improve ink           polymer with benzoic
                                                                 performance              acid, glycerol,
                                                                 Establishes a good       propylene glycol and
                                                                 flow and disperse        3a,4,7,7a-tetrahydro-
                                                                 pigment and has          1,3-
                                                                 lithographic             isobenzofurandione.
                                                                 properties.
P-23-0105A.........         3   05/02/2023  Heebut Materials,   (G) Plastic and rubber   (G) Multi-Walled Carbon
                                             LLC.                additive.                Nanotube.
P-23-0118..........         3   04/27/2023  CBI...............  (G) Reactant...........  (G) Glycerides from
                                                                                          fermentation of
                                                                                          genetically modified
                                                                                          microorganism,
                                                                                          ethoxylated, reaction
                                                                                          products with ethanol,
                                                                                          polycyclic isocyanate.
P-23-0127..........         2   05/18/2023  CBI...............  (S) Ingredient in        (G) Polysaccharide
                                                                 laundry detergent that   Lyase.
                                                                 is used for
                                                                 degradation of stains
                                                                 on fabric.
P-23-0128..........         2   05/17/2023  CBI...............  (G) Textile softening    (S) Fatty acids, C16-
                                                                 applications.            18, reaction products
                                                                                          with diethanolamine.
P-23-0129..........         3   05/16/2023  Polymer Additives,  (G) Used as an           (G) Soy or rapeseed
                                             Inc.                intermediate and will    fatty acid, benzyl
                                                                 be consumed internally   esters.
                                                                 by Valtris to make the
                                                                 end product which is
                                                                 intended to market to
                                                                 customers.
P-23-0133..........         1   05/08/2023  CBI...............  (G) Component in         (G) Fatty acids
                                                                 asphalt.                 reaction products with
                                                                                          alcoholamine reaction
                                                                                          by-products, salts.
P-23-0135..........         1   05/12/2023  CBI...............  (G) Destructive use....  (G) Alken-1-ol, 1-
                                                                                          acetate.
P-23-0136..........         1   05/17/2023  CBI...............  (G) Component in         (G) Fatty acids,
                                                                 asphalt.                 reaction products with
                                                                                          hexamethylenediamine
                                                                                          and 12-
                                                                                          hydroxyoctadecanoic
                                                                                          acid.

[[Page 40261]]

 
P-23-0140..........         2   05/23/2023  CBI...............  (G) Additive for         (G) Polysaccharide,
                                                                 consumer and             (hydroxytrialkylammoni
                                                                 commercial products.     o)alkyl ether,
                                                                                          chloride.
P-23-0141..........         1   05/23/2023  Hach Company......  (G) Buffer solution for  (S) 2-Butenedioic acid
                                                                 free chlorine            (2Z)-, potassium salt
                                                                 determination.           (1:?).
SN-16-0013A........         5   05/08/2023  CBI...............  (G) Surfactant.........  (G) Polyfluorinated
                                                                                          alkyl quaternary
                                                                                          ammonium chloride.
SN-20-0003A........        10   05/08/2023  CBI...............  (S) An anionic           (S) 1-Propanesulfonic
                                                                 fluorosurfactant used    acid, 2-methyl-2-[[1-
                                                                 in firefighting foam     oxo-3-
                                                                 concentrates such as     [(3,3,4,4,5,5,6,6,7,7,
                                                                 AFFF (Aqueous Film       8,8,8-
                                                                 Forming Foam) and AR-    tridecafluorooctyl)thi
                                                                 AFFF (Alcohol            o]propyl]amino]-,
                                                                 Resistant Aqueous Fim    sodium salt (1:1).
                                                                 Forming Foam).
SN-21-0011A........         3   05/11/2023  CBI...............  (G) Solvent............  (S) 2-Propanol, 1-
                                                                                          [bis(2-
                                                                                          hydroxyethyl)amino]-.
----------------------------------------------------------------------------------------------------------------

    In Table II of this unit, EPA provides the following information 
(to the extent that such information is not claimed as CBI) on the NOCs 
that have passed an initial screening by EPA during this period: The 
EPA case number assigned to the NOC including whether the submission 
was an initial or amended submission, the date the NOC was received by 
EPA, the date of commencement provided by the submitter in the NOC, a 
notation of the type of amendment (e.g., amendment to generic name, 
specific name, technical contact information, etc.) and chemical 
substance identity.

                             Table II--NOCs Approved * From 05/01/2023 to 05/31/2023
----------------------------------------------------------------------------------------------------------------
                                                                 If amendment,
          Case No.             Received date    Commencement        type of            Chemical substance
                                                    date           amendment
----------------------------------------------------------------------------------------------------------------
P-19-0185...................      05/11/2023        04/03/2023               N  (S) Benzoic acid, 2-chloro-3-
                                                                                 methyl-, sodium salt (1:1).
P-95-0224...................      05/16/2023        04/28/1995               N  (S) 2-propenoic acid,2-methyl-,2-
                                                                                 (dimethylamino)ethyl ester,
                                                                                 polymer with 1-ethenylhexahydro-
                                                                                 2h-azepin-2-one &
                                                                                 vinylpyrrolidone.
----------------------------------------------------------------------------------------------------------------
* The term `Approved' indicates that a submission has passed a quick initial screen ensuring all required
  information and documents have been provided with the submission.

    In Table III of this unit, EPA provides the following information 
(to the extent such information is not subject to a CBI claim) on the 
test information that has been received during this time period: The 
EPA case number assigned to the test information; the date the test 
information was received by EPA, the type of test information 
submitted, and chemical substance identity.

                       Table III--Test Information Received From 05/01/2023 to 05/31/2023
----------------------------------------------------------------------------------------------------------------
          Case No.             Received date      Type of test information             Chemical substance
----------------------------------------------------------------------------------------------------------------
P-23-0124...................      05/24/2023  Acute Oral Toxicity/              (G) Sulfonium, tricabocyclic-, 2-
                                               Pathogenicity (OCSPP Test         heteroatom-substituted-
                                               Guideline 885.3050); Bacterial    (halocarbocyclic)carboxylate
                                               Reverse Mutation Test (OECD       (1:1).
                                               Test Guideline 471).
----------------------------------------------------------------------------------------------------------------

    If you are interested in information that is not included in these 
tables, you may contact EPA's technical information contact or general 
information contact as described under FOR FURTHER INFORMATION CONTACT 
to access additional non-CBI information that may be available.
    Authority: 15 U.S.C. 2601 et seq.

    Dated: June 14, 2023.
Pamela Myrick,
Director, Project Management and Operations Division, Office of 
Pollution Prevention and Toxics.
[FR Doc. 2023-13165 Filed 6-20-23; 8:45 am]
BILLING CODE 6560-50-P


