[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]
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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.
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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 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
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Case No. Version Received date Manufacturer Use Chemical substance
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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)-.
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* The term `Approved' indicates that a submission has passed a quick initial screen ensuring all required information and documents have been provided
with the submission prior to the start of the 90 day review period, and in no way reflects the final status of a complete submission review.
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
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If amendment,
Case No. Received date Commencement type of Chemical substance
date amendment
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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.
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* The term `Approved' indicates that a submission has passed a quick initial screen ensuring all required
information and documents have been provided with the submission
In Table III of this unit, EPA provides the following information
(to the extent such information is not subject to a CBI claim) on the
test information that has been received during this time period: The
EPA case number assigned to the test information; the date the test
information was received by EPA, the type of test information
submitted, and chemical substance identity.
Table III--Test Information Received From 09/01/2021 to 09/30/2021
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Type of test
Case No. Received date information Chemical substance
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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).
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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]
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