Notice2021-25422
Certain New Chemicals; Receipt and Status Information for October 2021
Primary source
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Published
November 22, 2021
Issuing agencies
Environmental Protection Agency
Abstract
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.
Full Text
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<title>Federal Register, Volume 86 Issue 222 (Monday, November 22, 2021)</title>
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[Federal Register Volume 86, Number 222 (Monday, November 22, 2021)]
[Notices]
[Pages 66296-66299]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="http://www.regulations.gov">http://www.regulations.gov</a>. 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 <a href="http://www.epa.gov/dockets">http://www.epa.gov/dockets</a>.
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 <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
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: <a href="/cdn-cgi/l/email-protection#6e1c0f060f07400407032e0b1e0f40090118"><span class="__cf_email__" data-cfemail="6517040d040c4b0f0c08250015044b020a13">[email protected]</span></a>.
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: <a href="/cdn-cgi/l/email-protection#82d6d1c1c3afcaedf6eeebece7c2e7f2e3ace5edf4"><span class="__cf_email__" data-cfemail="4d191e0e0c60052239212423280d283d2c632a223b">[email protected]</span></a>.
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: <a href="https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/status-pre-manufacture-notices">https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/status-pre-manufacture-notices</a>. 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: <a href="https://www.epa.gov/tsca-inventory">https://www.epa.gov/tsca-inventory</a>.
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: <a href="http://www.epa.gov/oppt/newchems">http://www.epa.gov/oppt/newchems</a>.
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 <a href="http://regulations.gov">regulations.gov</a> 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 <a href="http://www.epa.gov/dockets/comments.html">http://www.epa.gov/dockets/comments.html</a>.
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: <a href="https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/status-pre-manufacture-notices">https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/status-pre-manufacture-notices</a>. 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
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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
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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 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.
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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 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).
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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).
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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: 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
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