Document ID: EPA-HQ-OPPT-2021-0068-0010
Agency: epa
Document Type: Notice
Title: Certain New Chemicals: Receipt and Status Information for October 2021
Posted Date: 2021-11-22T05:00Z

[Federal Register Volume 86, Number 222 (Monday, November 22, 2021)]
[Notices]
[Pages 66296-66299]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-25422]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2021-0068; FRL-8732-05-OCSPP]

Certain New Chemicals; Receipt and Status Information for October 
2021

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: EPA is required under the Toxic Substances Control Act (TSCA) 
to make information publicly available and to publish information in 
the Federal Register pertaining to submissions under TSCA, including 
notice of receipt of a Premanufacture notice (PMN), Significant New Use 
Notice (SNUN) or Microbial Commercial Activity Notice (MCAN), including 
an amended notice or test information; an exemption application 
(Biotech exemption); an application for a test marketing exemption 
(TME), both pending and/or concluded; a notice of commencement (NOC) of 
manufacture (including import) for new chemical substances; and a 
periodic status report on new chemical substances that are currently 
under EPA review or have recently concluded review. This document 
covers the period from 10/01/2021 to 10/31/2021.

DATES: Comments identified by the specific case number provided in this 
document must be received on or before December 22, 2021.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2021-0068, and the specific case number for the 
chemical substance related to your comment, through the Federal 
eRulemaking Portal at 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. 
Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://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 (MC 7407M), Office of Pollution Prevention and 
Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, 
Washington, DC 20460-0001; telephone number: (202) 564-8593; email 
address: [email protected].
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: [email protected].

SUPPLEMENTARY INFORMATION:

I. Executive Summary

A. What action is the Agency taking?

    This document provides the receipt and status reports for the 
period from 10/01/2021 to 10/31/2021. The Agency is providing notice of 
receipt of PMNs, SNUNs and MCANs (including amended notices and test 
information);

[[Page 66297]]

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

    Given public interest in information on the status of TSCA 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 TSCA 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.

[[Page 66298]]

                        Table I--PMN/SNUN/MCANs Approved * From 10/01/2021 to 10/31/2021
----------------------------------------------------------------------------------------------------------------
        Case No.           Version    Received date      Manufacturer             Use         Chemical substance
----------------------------------------------------------------------------------------------------------------
P-18-0273A..............          8      10/06/2021  CBI................  (G) Used in         (S) 1,4-
                                                                           polymer             Cyclohexanedicarb
                                                                           manufacturing.      oxylic acid, 1,4-
                                                                                               bis(2-ethylhexyl)
                                                                                               ester
P-21-0137...............          5      10/22/2021  Lamberti USA Inc...  (G) Industrial      (G) Triazine-
                                                                           additive.           trione,
                                                                                               tris(isocyanatoal
                                                                                               kyl)-, polymer
                                                                                               with substituted
                                                                                               diisocyanato
                                                                                               alkylcarbomonocyc
                                                                                               le, hydro-
                                                                                               hydroxypoly(oxyal
                                                                                               kanediyl)and
                                                                                               hydro-
                                                                                               hydroxypoly[oxy(a
                                                                                               lkyl-
                                                                                               alkanediyl)],
                                                                                               aliphatic alkyl
                                                                                               amine-blocked
P-21-0181A..............          4      10/25/2021  CBI................  (G) Color           (G) 1,3-
                                                                           developer.          Benzenedicarboxam
                                                                                               ide, N1,N3-
                                                                                               bis(carbomonocycl
                                                                                               ic)-5-
                                                                                               [[(carbomonocycli
                                                                                               c)amino]sulfonyl]-
 
P-21-0201A..............          7      10/13/2021  The Lewis Chemical   (S) The intention   (S) 1,3-
                                                      Company.             is for this         Propanediaminium,
                                                                           product to be       2-hydroxy-
                                                                           used as an offset   N1,N1,N1,N3,N3-
                                                                           to N,N,N',N',N''-   pentamethyl-N3-9-
                                                                           Pentamethyl-N-      octadecen-1-yl,
                                                                           tallow alkyl1,3-    chloride (1:2);
                                                                           propanediammonium  (S) 1,3-
                                                                           chloride (CAS       Propanediaminium,
                                                                           #68607-29-4) in a   2-hydroxy-
                                                                           cationic latex      N1,N1,N1,N3,N3-
                                                                           asphalt emulsion    pentamethyl-N3-
                                                                           formulation.        octadecyl-,
                                                                                               chloride
                                                                                               (1:2);(S) 1,3-
                                                                                               Propanediaminium,
                                                                                               2-hydroxy-
                                                                                               N1,N1,N1,N3,N3-
                                                                                               pentamethyl-N3-
                                                                                               tetradecyl-,
                                                                                               chloride (1:2);
                                                                                              (S) 1,3-
                                                                                               Propanediaminium,
                                                                                               N-hexadecyl-2-
                                                                                               hydroxy-
                                                                                               N,N,N',N',N'-
                                                                                               pentamethyl-,
                                                                                               dichloride (2CI);
P-21-0207A..............          5      10/21/2021  CBI................  (G) Emulsifier....  (G) Carboxy ether;
                                                                                               branched and
                                                                                               linear
                                                                                               ethercarboxylate;
P-21-0211A..............          4      10/01/2021  CBI................  (G) Process aid...  (G) Polycyclic
                                                                                               Dioxolane.
P-21-0211A..............          5      10/21/2021  CBI................  (G) Process aid...  (G) Polycyclic
                                                                                               Dioxolane.
SN-22-0001..............          1      10/06/2021  CBI................  (G) Component in    (S) Ethanol,
                                                                           polishing           2,2',2''-
                                                                           formulation.        nitrilotris-,
                                                                                               compd. with
                                                                                               .alpha.-[2,4,6-
                                                                                               tris(1-
                                                                                               phenylethyl)pheny
                                                                                               l]-.omega.-
                                                                                               hydroxypoly(oxy-
                                                                                               1,2-ethanediyl)
                                                                                               phosphate
----------------------------------------------------------------------------------------------------------------
* 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 10/01/2021 to 10/31/2021
----------------------------------------------------------------------------------------------------------------
                                            Commencement       If Amendment, type of
        Case No.           Received date        date                 amendment              Chemical substance
----------------------------------------------------------------------------------------------------------------
J-20-0022...............      10/07/2021       10/06/2021  N...........................  (G) Modified
                                                                                          saccharomyces
                                                                                          cerevisiae.
P-15-0607A..............      10/27/2021       07/26/2021  Withdrew CBI claim..........  (S) 1,2,4,5,7,8-
                                                                                          hexoxonane, 3,6,9-
                                                                                          trimethyl-, 3,6,9-
                                                                                          tris(et and pr)derivs.
P-18-0023...............      10/13/2021       09/30/2021  N...........................  (G) Propanediol
                                                                                          phosphate.
P-18-0024...............      10/06/2021       10/06/2021  N...........................  (G) Phosphate
                                                                                          epichlorohydrin
                                                                                          polymer.
P-18-0073...............      10/13/2021       10/11/2021  N...........................  (S) Sulfuric acid,
                                                                                          ammonium salt (1:?).
P-19-0098...............      09/30/2021       09/15/2021  N...........................  (G) Phosphoric acid,
                                                                                          polymer with
                                                                                          (hydroxyalkyl)-
                                                                                          alkanediol and
                                                                                          alkanediol.
P-19-0098A..............      10/25/2021       09/15/2021  Withdrew CBI claim..........  (S) Phosphoric acid,
                                                                                          polymer with 2,2-
                                                                                          bis(hydroxymethyl)-1,3-
                                                                                          propanediol and 1,2-
                                                                                          ethanediol.
P-21-0095...............      10/04/2021       09/30/2021  N...........................  (S) 1-tetradecene,
                                                                                          homopolymer,
                                                                                          hydrogenated, by-
                                                                                          products from, c28-42
                                                                                          fraction.
P-21-0125...............      10/14/2021       09/23/2021  N...........................  (S) Nonane, branched.
P-96-1181...............      10/14/2021       10/12/2021  N...........................  (G) Inorganic acid,
                                                                                          compds. with
                                                                                          [(substituted-
                                                                                          propyl)imino]bis[alkan
                                                                                          ol]-bisphenol a-
                                                                                          epichlorohydrin-
                                                                                          hexahydro-1,3-
                                                                                          isobenzofurandione-
                                                                                          polyethylene glycol
                                                                                          ether with bisphenol a
                                                                                          (2:1) polymer-
                                                                                          alkanolamine reaction
                                                                                          products.
P-98-0179...............      10/26/2021       10/07/2021  N...........................  (G)
                                                                                          Trialkoxysilylalkylami
                                                                                          no-alkyldioate.
----------------------------------------------------------------------------------------------------------------
* 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 10/01/2021 to 10/31/2021
----------------------------------------------------------------------------------------------------------------
             Case No.               Received date      Type of test information           Chemical substance
----------------------------------------------------------------------------------------------------------------
P-14-0712........................      10/11/2021  Quarterly PCDD/F Test of PMN      (G) Plastics, wastes,
                                                    Substance using EPA Test Method   pyrolyzed, bulk
                                                    8290A.                            pyrolysate.
P-16-0150........................      10/19/2021  96-Hour Static Toxicity Test      (G) Chlorofluorocarbon.
                                                    with Marine Diatom (Skeletonema
                                                    Costatum), 96-Hour Static Acute
                                                    Toxicity Test with Sheepshead
                                                    Minnow (Cyprinodon Variegatus),
                                                    and 96-Hour Static Acute
                                                    Toxicity Test with Saltwater
                                                    Mysid (Americamysis Bahia).

[[Page 66299]]

 
P-18-0016........................      10/12/2021  Notice of Study Schedule........  (G) Aromatic sulfonium
                                                                                      tricyclo fluoroalkyl
                                                                                      sulfonic acid salt.
P-18-0124........................      10/01/2021  Draft Protocols for a 90-Day      (G) Alkali nickel oxide.
                                                    Inhalation Toxicity Study of
                                                    Lithium Nickel Potassium Oxide
                                                    (KDLNO) in Sprague Dawley Rats
                                                    with 8-Week Recovery Period and
                                                    a 4-Week Inhalation Toxicity
                                                    Study of Lithium Nickel
                                                    Potassium Oxide (KDLNO) in
                                                    Sprague Dawley Rats with a 2-
                                                    Week Recovery.
P-20-0014........................      10/21/2021  Fish Acute Toxicity Mitigated by  (G) Sugars, polymer with
                                                    Humic Acid (OCSPP Test            alkanetriamine.
                                                    Guidelines 850.1085).
P-20-0042........................      10/12/2021  Notice of Study Schedule........  (G) Sulfonium, trisaryl-,
                                                                                      7,7-dialkyl-2-
                                                                                      heteropolycyclic -1-
                                                                                      alkanesulfonic acid (1:1).
P-20-0174........................      09/30/2021  Partition Coefficient (n-Octanol/ (S) 6-octen-1-ol, 3,7-
                                                    Water) Estimation by Liquid       dimethyl-, homopolymer,
                                                    Chromatography (Test Guidelines   monoacetate.
                                                    OCSPP 830.7570).
P-20-0184........................      09/30/2021  Partition Coefficient (n-Octanol/ (S) 6-octen-1-ol, 3,7-
                                                    Water) Estimation by Liquid       dimethyl-, homopolymer.
                                                    Chromatography (Test Guidelines
                                                    OCSPP 830.7570) and Partition
                                                    Coefficient (n-octanol/water)
                                                    HPLC Method (Test Guidelines
                                                    OECD 117).
----------------------------------------------------------------------------------------------------------------

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

    Dated: November 9, 2021.
Pamela Myrick,
Director, Project Management and Operations Division, Office of 
Pollution Prevention and Toxics.
[FR Doc. 2021-25422 Filed 11-19-21; 8:45 am]
BILLING CODE 6560-50-P