[Federal Register Volume 87, Number 101 (Wednesday, May 25, 2022)]
[Notices]
[Pages 31882-31886]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-11184]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2022-0132; FRL-9411-02-OCSPP]


Certain New Chemicals; Receipt and Status Information for April 
2022

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: EPA is required under the Toxic Substances Control Act (TSCA), 
as amended by the Frank R. Lautenberg Chemical Safety for the 21st 
Century Act, to make information publicly available and to publish 
information in the Federal Register pertaining to submissions under 
TSCA Section 5, including notice of receipt of a Premanufacture notice 
(PMN), Significant New Use Notice (SNUN) or Microbial Commercial 
Activity Notice (MCAN), including an amended notice or test 
information; an exemption application (Biotech exemption); an 
application for a test marketing exemption (TME), both pending and/or 
concluded; a notice of commencement (NOC) of manufacture (including 
import) for new chemical substances; and a periodic status report on 
new chemical substances that are currently under EPA review or have 
recently concluded review. This document covers the period from 04/01/
2022 to 04/30/2022.

DATES: Comments identified by the specific case number provided in this 
document must be received on or before June 24, 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, by one of the following 
methods:
     Federal eRulemaking Portal: http://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.
     Mail: Document Control Office (7407M), Office of Pollution 
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 
Pennsylvania Ave. NW, Washington, DC 20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.html.
    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

[[Page 31883]]

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 04/01/2022 to 04/30/2022. The Agency is providing notice of 
receipt of PMNs, SNUNs, and MCANs (including amended notices and test 
information); an exemption application under 40 CFR part 725 (Biotech 
exemption); TMEs, both pending and/or concluded; NOCs to manufacture a 
new chemical substance; and a periodic status report on new chemical 
substances that are currently under EPA review or have recently 
concluded review.
    EPA is also providing information on its website about cases 
reviewed under the amended TSCA, including the section 5 PMN/SNUN/MCAN 
and exemption notices received, the date of receipt, the final EPA 
determination on the notice, and the effective date of EPA's 
determination for PMN/SNUN/MCAN notices on its website at: 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.

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.

[[Page 31884]]

    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 04/01/2022 to 04/30/2022
----------------------------------------------------------------------------------------------------------------
                                               Received                                             Chemical
           Case No.               Version        date        Manufacturer           Use             substance
----------------------------------------------------------------------------------------------------------------
J-22-0012.....................            1   04/01/2022  Danisco US, Inc..  (G) Production of  (G) Genetically
                                                                              a chemical         modified
                                                                              substance.         microorganism
                                                                                                 for the
                                                                                                 production of a
                                                                                                 chemical
                                                                                                 substance.
J-22-0012A....................            2   04/20/2022  Danisco US, Inc..  (G) Production of  (G) Genetically
                                                                              a chemical         modified
                                                                              substance.         microorganism
                                                                                                 for the
                                                                                                 production of a
                                                                                                 chemical
                                                                                                 substance.
J-22-0013.....................            1   04/01/2022  Danisco US, Inc..  (G) Production of  (G) Genetically
                                                                              a chemical         modified
                                                                              substance.         microorganism
                                                                                                 for the
                                                                                                 production of a
                                                                                                 chemical
                                                                                                 substance.
J-22-0013A....................            2   04/20/2022  Danisco US, Inc..  (G) Production of  (G) Genetically
                                                                              a chemical         modified
                                                                              substance.         microorganism
                                                                                                 for the
                                                                                                 production of a
                                                                                                 chemical
                                                                                                 substance.
P-21-0088.....................            4   04/18/2022  Solepoxy, Inc....  (G) Molding        (G) Heterocyclic
                                                                              compound.          epoxide polymer
                                                                                                 with mixed
                                                                                                 substituted
                                                                                                 glycols and
                                                                                                 acid anhydride.
P-21-0191A....................            3   04/11/2022  Santolubes         (S) This product   (S) Fatty acids,
                                                           Manufacturing,     will be used in    C18-unsatd.,
                                                           LLC.               gear oils &        dimers,
                                                                              greases, wind      hydrogenated,
                                                                              turbines, HX-1     polymers with
                                                                              (incidental food   polyethylene
                                                                              contact)           glycol,
                                                                              lubricants and     dihexanoates.
                                                                              EV (Electric
                                                                              Vehicle) motors.
                                                                              It will be used
                                                                              by OEMs in these
                                                                              applications as
                                                                              components in
                                                                              finished
                                                                              formulations.
                                                                              The intended use
                                                                              of these
                                                                              products is 100%
                                                                              industrial and
                                                                              not intended for
                                                                              use as consumer
                                                                              products.
P-21-0199A....................            5   04/18/2022  CBI..............  (G) Processing     (G) 1,6-
                                                                              aid.               Disubstituted
                                                                                                 hexane.
P-22-0059.....................            2   04/13/2022  CBI..............  (S) Use of enzyme  (S)
                                                                              in laundry and     Thermomycolin,
                                                                              dishwashing        fermented, from
                                                                              detergents.        a modified
                                                                                                 Trichoderma
                                                                                                 reesei.
P-22-0060.....................            1   03/31/2022  CBI..............  (G) Intermediate.  (G) Polyol allyl
                                                                                                 ether,
                                                                                                 homopolymer
                                                                                                 terpene ether.
P-22-0061.....................            1   03/31/2022  CBI..............  (G) Intermediate.  (G) Polyol allyl
                                                                                                 ether,
                                                                                                 homopolymer,
                                                                                                 alkyl ethers.
P-22-0062.....................            1   04/01/2022  Vertellus          (G) Fuel and Oil   (G) Alkene,
                                                           Specialties, Inc.  additive for       heterocycle.
                                                                              consumer,
                                                                              industrial, and
                                                                              commercial
                                                                              applications.
P-22-0063.....................            1   04/01/2022  Vertellus          (G) Fuel and Oil   (G) Alkene,
                                                           Specialties, Inc.  additive for       heterocycle.
                                                                              consumer,
                                                                              industrial, and
                                                                              commercial
                                                                              applications.
P-22-0064.....................            1   04/01/2022  CBI..............  (G) Intermediate.  (G) Polyol allyl
                                                                                                 ether, polymer
                                                                                                 with alkylene
                                                                                                 oxides, terpene
                                                                                                 ether.
P-22-0065.....................            1   04/01/2022  CBI..............  (G) Intermediate.  (G) Polyol allyl
                                                                                                 ether, polymer
                                                                                                 with alkylene
                                                                                                 oxides, alkyl
                                                                                                 ethers.
P-22-0066.....................            2   04/26/2022  CBI..............  (G) Additive for   (G) Polyol allyl
                                                                              adhesives and      ether, polymer
                                                                              coatings.          with alkylene
                                                                                                 oxides, terpene
                                                                                                 ether sulfate,
                                                                                                 ammonium salt.
P-22-0067.....................            2   04/26/2022  CBI..............  (G) Additive for   (G) Polyol allyl
                                                                              adhesives and      ether, polymer
                                                                              coatings.          with alkylene
                                                                                                 oxides, alkyl
                                                                                                 ether sulfate,
                                                                                                 ammonium salts.

[[Page 31885]]

 
P-22-0069.....................            1   04/08/2022  CBI..............  (G) Component in   (G)
                                                                              battery.           fluoroheteroaci
                                                                                                 d, metal salt.
P-22-0070.....................            2   04/20/2022  CBI..............  (G) Dispersant     (G)
                                                                              polymer for        Alkylaromatic
                                                                              coatings.          sulfonic acid,
                                                                                                 alkyl ester,
                                                                                                 compds. with
                                                                                                 phenol-
                                                                                                 formaldehyde
                                                                                                 polymer with
                                                                                                 amino-
                                                                                                 polyethylene-
                                                                                                 polypropylene
                                                                                                 glycol-oxirane
                                                                                                 copolymer and
                                                                                                 benzoates.
P-22-0071.....................            2   04/14/2022  Lamberti USA, Inc  (G) Industrial     (S) D-
                                                                              Surfactant.        Glucopyranose,
                                                                                                 oligomeric,
                                                                                                 maleates, C9-11-
                                                                                                 branched and
                                                                                                 linear alkyl
                                                                                                 glycosides,
                                                                                                 sulfonated,
                                                                                                 potassium
                                                                                                 salts.
P-22-0072.....................            2   04/14/2022  Lamberti USA, Inc  (G) Industrial     (S) D-
                                                                              Surfactant.        Glucopyranose,
                                                                                                 oligomeric,
                                                                                                 maleates, decyl
                                                                                                 octyl
                                                                                                 glycosides,
                                                                                                 sulfonated,
                                                                                                 potassium
                                                                                                 salts.
P-22-0073.....................            2   04/14/2022  Lamberti USA, Inc  (G) Industrial     (S) D-
                                                                              Surfactant.        Glucopyranose,
                                                                                                 oligomeric,
                                                                                                 maleates, C10-
                                                                                                 16-alkyl
                                                                                                 glycosides,
                                                                                                 sulfonated,
                                                                                                 potassium
                                                                                                 salts.
P-22-0076.....................            1   04/13/2022  Earth Science      (S) PABP-P will    (S) Phosphoric
                                                           Laboratories HQ.   be used as a       acid, ammonium
                                                                              carrier in         salt (1:?).
                                                                              agricultural
                                                                              (non-pesticide)
                                                                              micronutrient
                                                                              products. To
                                                                              formulate
                                                                              corrosion
                                                                              control products
                                                                              used to minimize
                                                                              corrosion of
                                                                              steel pipes in
                                                                              industrial water
                                                                              towers.
P-22-0082.....................            1   04/25/2022  CBI..............  (G) Component of   (G) Alkenoic
                                                                              photoresist.       acid, alkyl,
                                                                                                 carbopolycyclic
                                                                                                 alkyl ester,
                                                                                                 polymer with
                                                                                                 trihalo
                                                                                                 (trihaloalkyl)
                                                                                                 alkyl alkyl
                                                                                                 alkenoate.
----------------------------------------------------------------------------------------------------------------
* The term `Approved' indicates that a submission has passed a quick initial screen ensuring all required
  information and documents have been provided with the submission prior to the start of the 90 day review
  period, and in no way reflects the final status of a complete submission review.

    In Table II of this unit, EPA provides the following information 
(to the extent that such information is not 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 04/01/2022 to 04/30/2022
----------------------------------------------------------------------------------------------------------------
                                                     Commencement   If amendment, type of
             Case No.                Received date       date             amendment          Chemical substance
----------------------------------------------------------------------------------------------------------------
P-16-0150A........................      04/04/2022      11/29/2018  Revised generic name.  (G)
                                                                                            Chlorofluoroalkane.
P-16-0532A........................      03/30/2022      04/17/2019  Revised generic name.  (G) Carboxylic acid
                                                                                            substituted lactam.
P-18-0013A........................      04/21/2022      06/30/2021  Revised generic name.  (G) Sulfonium,
                                                                                            phenolcarbopolycycle
                                                                                            , inner salt.
P-18-0257.........................      04/22/2022      04/20/2022  N....................  (S) Phosphoric acid,
                                                                                            potassium salt
                                                                                            (2:3).
P-19-0147A........................      04/29/2022      01/29/2021  Revised generic name.  (G) Polyethylene
                                                                                            glycol alkyl ether,
                                                                                            alkyl ester.
P-19-0165.........................      04/12/2022      03/15/2022  N....................  (G) Tall-oil pitch,
                                                                                            fraction, sterol-
                                                                                            low.
P-20-0010.........................      04/08/2022      03/31/2022  N....................  (G) Thio organic
                                                                                            substituted metal
                                                                                            salt.
P-21-0201.........................      04/20/2022      04/19/2022  N....................  (G) Tetradecyl
                                                                                            diamine pentamethyl
                                                                                            dichloride.
P-21-0201.........................      04/20/2022      04/19/2022  N....................  (G) Oleyl diamine
                                                                                            pentamethyl
                                                                                            dichloride.

[[Page 31886]]

 
P-21-0201.........................      04/20/2022      04/19/2022  N....................  (G) Hexadecyl diamine
                                                                                            pentamethyl
                                                                                            dichloride.
P-21-0201.........................      04/20/2022      04/19/2022  N....................  (G) Octadecyl diamine
                                                                                            pentamethyl
                                                                                            dichloride.
P-21-0206.........................      04/22/2022      03/28/2022  N....................  (G) Alkanes, branched
                                                                                            and linear.
----------------------------------------------------------------------------------------------------------------
* 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 04/01/2022 to 04/30/2022
----------------------------------------------------------------------------------------------------------------
                Case No.                   Received date   Type of test information       Chemical substance
----------------------------------------------------------------------------------------------------------------
P-14-0712...............................      04/19/2022  Polychlorinated             (S) Waste plastics,
                                                           Dibenzodioxins and          pyrolyzed, C5-55
                                                           Polychlorinated             fraction.
                                                           dibenzofurans Testing.
P-16-0543...............................      04/19/2022  Exposure Monitoring Report  (G) Halogenophosphoric
                                                                                       acid metal salt.
P-20-0014...............................      04/04/2022  Acute Inhalation Toxicity   (G) Sugars, polymer with
                                                           Testing (OECD Test          alkanetriamine.
                                                           Guideline 403).
----------------------------------------------------------------------------------------------------------------

    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: May 18, 2022.
Pamela Myrick,
Director, Project Management and Operations Division, Office of 
Pollution Prevention and Toxics.
[FR Doc. 2022-11184 Filed 5-24-22; 8:45 am]
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