[Federal Register Volume 86, Number 202 (Friday, October 22, 2021)]
[Notices]
[Pages 58658-58662]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-23085]


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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2021-0068; FRL-8732-04-OCSPP]


Certain New Chemicals; Receipt and Status Information for 
September 2021

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

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 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 09/01/2021 to 09/30/2021.

DATES: Comments identified by the specific case number provided in this 
document must be received on or before November 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 09/01/2021 to 09/30/2021. 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

[[Page 58659]]

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.
    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 09/01/2021 to 09/30/2021
--------------------------------------------------------------------------------------------------------------------------------------------------------
               Case No.                  Version     Received date        Manufacturer                     Use                   Chemical substance
--------------------------------------------------------------------------------------------------------------------------------------------------------
P-18-0049A...........................            8      09/28/2021  Solvay Fluorides LLC....  (G) Coating component/        (G) Mixed metal halide.
                                                                                               processing aid.
P-18-0128A...........................            6      09/14/2021  CBI.....................  (G) Surface modifier........  (S) Inulin, 2-hydroxy-3-
                                                                                                                             (trimethylammonio)propyl
                                                                                                                             ether, chloride.
P-20-0018A...........................            4      09/24/2021  CBI.....................  (G) Component in candles....  (G) Fatty acid dimers,
                                                                                                                             polymers with glycerol and
                                                                                                                             triglycerides.
P-20-0019A...........................            4      09/24/2021  CBI.....................  (G) Component in candles....  (G) Fatty acid dimers,
                                                                                                                             polymers with glycerol and
                                                                                                                             triglycerides.
P-20-0020A...........................            4      09/24/2021  CBI.....................  (G) Component in candles....  (G) Fatty acid dimers,
                                                                                                                             polymers with glycerol and
                                                                                                                             triglycerides.
P-20-0021A...........................            4      09/24/2021  CBI.....................  (G) Component in candles....  (G) Fatty acid dimers,
                                                                                                                             polymers with glycerol and
                                                                                                                             fatty acids.
P-20-0105A...........................            5      09/02/2021  Sound Agriculture         (S) To promote microbial      (S) 4H-Pyran-4-one, 3-[(2,5-
                                                                     Company.                  activity in the soil (for     dihydro-4-methyl-5-oxo-2-
                                                                                               use on commercial farming     furanyl)oxy]-2-methyl-.
                                                                                               operations).
P-21-0016A...........................            2      09/27/2021  CBI.....................  (G) Paint additive, Additive  (G) Alkanoic acid, dialkyl
                                                                                               in coating formulations,      ester.
                                                                                               Component in cleaning
                                                                                               agents.
P-21-0106A...........................            3      09/02/2021  Eastman Chemical          (S) Chemical additive for     (G) Distillates (petroleum),
                                                                     Company, Inc.             production of tire and non-   polymers with branched
                                                                                               tire rubber products.         alkene.
P-21-0107A...........................            3      09/02/2021  Eastman Chemical          (S) Chemical additive for     (G) Distillates (petroleum),
                                                                     Company, Inc.             production of tire and non-   polymers with branched
                                                                                               tire rubber products.         alkene, hydrogenated.
P-21-0172............................            4      08/31/2021  Silco, Inc..............  (S) Moisture reactive         (G) Siloxanes and Silicones,
                                                                                               polymer for use in sealants   di-Me, trimethoxysilyl
                                                                                               and coatings.                 group terminated.
P-21-0172A...........................            5      09/30/2021  Silco, Inc..............  (S) Moisture reactive         (G) Siloxanes and Silicones,
                                                                                               polymer for use in sealants   di-Me, trimethoxysilyl
                                                                                               and coatings.                 group terminated.

[[Page 58660]]

 
P-21-0178A...........................            3      09/10/2021  CBI.....................  (G) Coating additive........  (G) Bisphenol A, polymer
                                                                                                                             with aminoalkylalkyl-
                                                                                                                             aminoalkylalkyl-poly[(oxy-
                                                                                                                             alkyl-alkanepolyol)],
                                                                                                                             haloalkyl-epoxide, epoxy-
                                                                                                                             epoxyalkoxy-poly[(oxy-alkyl-
                                                                                                                             alkanepolyol)], sulfur-
                                                                                                                             based salt.
P-21-0179A...........................            3      09/10/2021  CBI.....................  (G) Coating additive........  (G) Substituted-alkanoic
                                                                                                                             acid, compd. with
                                                                                                                             aminoalkylalkyl-
                                                                                                                             aminoalkylalkyl-poly[(oxy-
                                                                                                                             alkyl-alkanepolyol)]
                                                                                                                             polymer with haloalkyl-
                                                                                                                             epoxide, bisphenol A,epoxy-
                                                                                                                             epoxyalkoxy-poly[(oxy-alkyl-
                                                                                                                             alkanepolyol)].
P-21-0181A...........................            3      09/02/2021  CBI.....................  (G) Color developer.........  (G) 1,3-
                                                                                                                             Benzenedicarboxamide, N1,N3-
                                                                                                                             bis(carbomonocyclic)-5-
                                                                                                                             [[(carbomonocyclic)amino]su
                                                                                                                             lfonyl]-.
P-21-0190A...........................            2      09/17/2021  Santolubes Manufacturing  (S) This product will be      (S) Poly(oxy-1,2-ethanediyl)-
                                                                     LLC.                      used in gear oils &           alpha-(1-oxohexyl)-omega-
                                                                                               greases, wind turbines, HX-   [(1-oxohexyl)oxy]-.
                                                                                               1 (incidental food contact)
                                                                                               lubricants and EV (Electric
                                                                                               Vehicle) motors.
P-21-0191A...........................            2      09/17/2021  Santolubes Manufacturing  (S) This product will be      (S) Fatty acids, C18-
                                                                     LLC.                      used in gear oils &           unsatd., dimers,
                                                                                               greases, wind turbines, HX-   hydrogenated, polymers with
                                                                                               1 (incidental food contact)   polyethylene glycol,
                                                                                               lubricants and EV (Electric   dihexanoates.
                                                                                               Vehicle) motors.
P-21-0192A...........................            2      09/17/2021  Santolubes Manufacturing  (S) This product will be      (S) Fatty acids, C18-
                                                                     LLC.                      used in gear oils &           unsatd., dimers,
                                                                                               greases, wind turbines, HX-   hydrogenated, polymers with
                                                                                               1 (incidental food contact)   polyethylene glycol,
                                                                                               lubricants and EV (Electric   diesters with C8-10 fatty
                                                                                               Vehicle) motors.              acids.
P-21-0193A...........................            3      09/17/2021  Santolubes Manufacturing  (S) This product will be      (S) Fatty acids, C8-10,
                                                                     LLC.                      used in gear oils &           diesters with polyethylene
                                                                                               greases, wind turbines, HX-   glycol.
                                                                                               1 (incidental food contact)
                                                                                               lubricants and EV (Electric
                                                                                               Vehicle) motors.
P-21-0199A...........................            4      09/22/2021  CBI.....................  (G) Processing aid..........  (G) 1,6-Disubstituted
                                                                                                                             hexane.
P-21-0201............................            5      08/30/2021  The Lewis Chemical        (S) The intention is for      (S) 1,3-Propanediaminium, 2-
                                                                     Company.                  this product to be used as    hydroxy-N1,N1,N1,N3,N3-
                                                                                               an offset to N,N,N',N',N''-   pentamethyl-N3-tetradecyl-,
                                                                                               Pentamethyl-N-tallow          chloride (1:2); 1,3-
                                                                                               alkyl1,3- propanediammonium   Propanediaminium, N-
                                                                                               chloride (CAS#68607-29-4)     hexadecyl-2-hydroxy-
                                                                                               in a cationic latex asphalt   N,N,N',N',N'-pentamethyl-,
                                                                                               emulsion formulation.         dichloride (2CI); 1,3-
                                                                                                                             Propanediaminium, 2-hydroxy-
                                                                                                                             N1,N1,N1,N3,N3-pentamethyl-
                                                                                                                             N3-octadecyl-, chloride
                                                                                                                             (1:2); 1,3-
                                                                                                                             Propanediaminium, 2-hydroxy-
                                                                                                                             N1,N1,N1,N3,N3-pentamethyl-
                                                                                                                             N3-9-octadecen-1-yl,
                                                                                                                             chloride (1:2).
P-21-0206A...........................            2      09/10/2021  HollyFrontier             (G) Component of gasoline...  (G) Alkanes, branched and
                                                                     Corporation.                                            linear.
P-21-0211............................            3      09/01/2021  CBI.....................  (G) process aid.............  (G) Polycyclic Dioxolane.
P-21-0212............................            2      09/06/2021  Orient Corporation of     (S) Luminescent material for  (G) Europium,
                                                                     America.                  security ink.                 tris[polyfluoro-1-(2-
                                                                                                                             carbopolycyclic)-1,3-
                                                                                                                             butanedionato-
                                                                                                                             .kappa.O1,.kappa.O3]-.
P-21-0214............................            1      08/31/2021  ICM Products Inc........  (G) Textile finishing agent.  (G) Poly(oxy-1,2-
                                                                                                                             ethanediyl),
                                                                                                                             alpha,alpha',alpha''-
                                                                                                                             (trialkylamino)tris[omega-
                                                                                                                             hydroxy-, alkyl (ester).

[[Page 58661]]

 
P-21-0215............................            1      09/10/2021  Coventya, Inc...........  (S) The PMN substance is      (S) Pyridinium, 3-carboxy-1-
                                                                                               used in a primarily aqueous   methyl-, inner salt.
                                                                                               alkaline electroplating
                                                                                               solution that produces a
                                                                                               nominal zinc (Zn) nickel
                                                                                               (Ni) alloy deposit on iron
                                                                                               bearing substrates. The PMN
                                                                                               substance is a secondary
                                                                                               brightening additive that
                                                                                               is used in instances where
                                                                                               the inherent specularity of
                                                                                               the plating deposit is
                                                                                               unsatisfactory.
P-21-0216............................            1      09/17/2021  CBI.....................  (G) Additive in electrode     (G) Multi-walled carbon
                                                                                               materials, Additive in        nanotubes.
                                                                                               plastics.
P-21-0217............................            1      09/17/2021  CBI.....................  (G) Additive in electrode     (G) Multi-walled carbon
                                                                                               materials, Component in       nanotubes.
                                                                                               electrodes, thermoplastics.
SN-21-0003A..........................            2      09/13/2021  Norquay Technology Inc..  (G) Intermediate............  (S) 1,1'-Biphenyl, 4,4'-
                                                                                                                             dibromo-.
SN-21-0008A..........................            3      09/30/2021  CBI.....................  (G) Test media, Specialty     (S) 2-Butene, 1,1,1,4,4,4-
                                                                                               fluid, Clean agent system,    hexafluoro-, (2Z)-.
                                                                                               (S) Heat transfer system,
                                                                                               Foam expansion agent.
SN-21-0009A..........................            3      09/30/2021  CBI.....................  (G) Not Applicable; Chemical  (S) 2-Butene, 1,1,1,4,4,4-
                                                                                               Withdrawn.                    hexafluoro-, (2E)-.
--------------------------------------------------------------------------------------------------------------------------------------------------------
* 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 09/01/2021 to 09/30/2021
----------------------------------------------------------------------------------------------------------------
                                                                        If amendment,
             Case No.                Received date     Commencement        type of         Chemical substance
                                                           date           amendment
----------------------------------------------------------------------------------------------------------------
P-18-0012........................        09/15/2021        08/31/2021               N   (G) Polyester polyol.
P-18-0126........................        09/21/2021        09/13/2021               N   (S) Calcium manganese
                                                                                         titanium oxide.
P-18-0154........................        09/02/2021        08/27/2021               N   (G) Isocyanic acid,
                                                                                         polyalkylenepolycycloal
                                                                                         kylene ester, 2-alkoxy
                                                                                         alkanol and 1-alkoxy
                                                                                         alkanol and alkylene
                                                                                         diol blocked.
P-19-0019........................        09/10/2021        08/21/2021               N   (G) Haloalkane.
P-19-0020........................        09/01/2021        08/27/2021               N   (G) Alkyl salicylate,
                                                                                         metal salts.
P-21-0087........................        09/17/2021        09/12/2021               N   (G) Syrups, hydrolyzed
                                                                                         starch, dehydrated,
                                                                                         polymers with
                                                                                         methacrylic acid and
                                                                                         alkenenylbenzene.
----------------------------------------------------------------------------------------------------------------
* 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 09/01/2021 to 09/30/2021
----------------------------------------------------------------------------------------------------------------
                                                                      Type of test
               Case No.                     Received date             information           Chemical substance
----------------------------------------------------------------------------------------------------------------
P-14-0712............................  09/22/2021.............  Quarterly PCDD/F Test    (G) Plastics, wastes,
                                                                 of PMN Substance using   pyrolyzed, bulk
                                                                 EPA Test Method 8290A.   pyrolysate.
P-16-0543............................  08/30/2021.............  Exposure Monitoring      (G) Halogenophosphoric
                                                                 Report.                  acid metal salt.

[[Page 58662]]

 
P-16-0543............................  09/23/2021.............  Exposure Monitoring      (G) Halogenophosphoric
                                                                 Report.                  acid metal salt.
P-19-0049............................  09/17/2021.............  Fish Acute Toxicity      (G) Fatty acids,
                                                                 Test with Humic Acid,    polymers with
                                                                 Daphnia Acute Toxicity   substituted
                                                                 Test, and Green Algae    carbomonocycles,
                                                                 96-Hour Toxicity Test.   dialkanolamine, alkyl
                                                                                          substituted
                                                                                          alkanediamine and halo-
                                                                                          substituted
                                                                                          heteromonocycle,
                                                                                          formates (salts).
----------------------------------------------------------------------------------------------------------------

    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: October 18, 2021.
Pamela Myrick,
Director, Project Management and Operations Division, Office of 
Pollution Prevention and Toxics.
[FR Doc. 2021-23085 Filed 10-21-21; 8:45 am]
BILLING CODE 6560-50-P


