Notice2022-11184
Certain New Chemicals; Receipt and Status Information for April 2022
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Published
May 25, 2022
Issuing agencies
Environmental Protection Agency
Abstract
EPA is required under the Toxic Substances Control Act (TSCA), as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act, to make information publicly available and to publish information in the Federal Register pertaining to submissions under TSCA Section 5, including notice of receipt of a Premanufacture notice (PMN), Significant New Use Notice (SNUN) or Microbial Commercial Activity Notice (MCAN), including an amended notice or test information; an exemption application (Biotech exemption); an application for a test marketing exemption (TME), both pending and/or concluded; a notice of commencement (NOC) of manufacture (including import) for new chemical substances; and a periodic status report on new chemical substances that are currently under EPA review or have recently concluded review. This document covers the period from 04/01/ 2022 to 04/30/2022.
Full Text
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<title>Federal Register, Volume 87 Issue 101 (Wednesday, May 25, 2022)</title>
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[Federal Register Volume 87, Number 101 (Wednesday, May 25, 2022)]
[Notices]
[Pages 31882-31886]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-11184]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2022-0132; FRL-9411-02-OCSPP]
Certain New Chemicals; Receipt and Status Information for April
2022
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: EPA is required under the Toxic Substances Control Act (TSCA),
as amended by the Frank R. Lautenberg Chemical Safety for the 21st
Century Act, to make information publicly available and to publish
information in the Federal Register pertaining to submissions under
TSCA Section 5, including notice of receipt of a Premanufacture notice
(PMN), Significant New Use Notice (SNUN) or Microbial Commercial
Activity Notice (MCAN), including an amended notice or test
information; an exemption application (Biotech exemption); an
application for a test marketing exemption (TME), both pending and/or
concluded; a notice of commencement (NOC) of manufacture (including
import) for new chemical substances; and a periodic status report on
new chemical substances that are currently under EPA review or have
recently concluded review. This document covers the period from 04/01/
2022 to 04/30/2022.
DATES: Comments identified by the specific case number provided in this
document must be received on or before June 24, 2022.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2022-0132, and the specific case number for the
chemical substance related to your comment, by one of the following
methods:
<bullet> Federal eRulemaking Portal: <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.
<bullet> Mail: Document Control Office (7407M), Office of Pollution
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC 20460-0001.
<bullet> Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at <a href="http://www.epa.gov/dockets/contacts.html">http://www.epa.gov/dockets/contacts.html</a>.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at <a href="https://www.epa.gov/dockets">https://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 (7407M), Office of
[[Page 31883]]
Pollution Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number:
(202) 564-8593; email address: <a href="/cdn-cgi/l/email-protection#1567747d747c3b7f7c78557065743b727a63"><span class="__cf_email__" data-cfemail="fb899a939a92d5919296bb9e8b9ad59c948d">[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#5400071715791c3b20383d3a31143124357a333b22"><span class="__cf_email__" data-cfemail="ebbfb8a8aac6a3849f8782858eab8e9b8ac58c849d">[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 04/01/2022 to 04/30/2022. The Agency is providing notice of
receipt of PMNs, SNUNs, and MCANs (including amended notices and test
information); an exemption application under 40 CFR part 725 (Biotech
exemption); TMEs, both pending and/or concluded; NOCs to manufacture a
new chemical substance; and a periodic status report on new chemical
substances that are currently under EPA review or have recently
concluded review.
EPA is also providing information on its website about cases
reviewed under the amended TSCA, including the section 5 PMN/SNUN/MCAN
and exemption notices received, the date of receipt, the final EPA
determination on the notice, and the effective date of EPA's
determination for PMN/SNUN/MCAN notices on its website at: <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
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: <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.
[[Page 31884]]
As used in each of the tables in this unit, (S) indicates that the
information in the table is the specific information provided by the
submitter, and (G) indicates that this information in the table is
generic information because the specific information provided by the
submitter was claimed as CBI. Submissions which are initial submissions
will not have a letter following the case number. Submissions which are
amendments to previous submissions will have a case number followed by
the letter ``A'' (e.g. P-18-1234A). The version column designates
submissions in sequence as ``1'', ``2'', ``3'', etc. Note that in some
cases, an initial submission is not numbered as version 1; this is
because earlier version(s) were rejected as incomplete or invalid
submissions. Note also that future versions of the following tables may
adjust slightly as the Agency works to automate population of the data
in the tables.
Table I--PMN/SNUN/MCANs Approved * From 04/01/2022 to 04/30/2022
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Received Chemical
Case No. Version date Manufacturer Use substance
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J-22-0012..................... 1 04/01/2022 Danisco US, Inc.. (G) Production of (G) Genetically
a chemical modified
substance. microorganism
for the
production of a
chemical
substance.
J-22-0012A.................... 2 04/20/2022 Danisco US, Inc.. (G) Production of (G) Genetically
a chemical modified
substance. microorganism
for the
production of a
chemical
substance.
J-22-0013..................... 1 04/01/2022 Danisco US, Inc.. (G) Production of (G) Genetically
a chemical modified
substance. microorganism
for the
production of a
chemical
substance.
J-22-0013A.................... 2 04/20/2022 Danisco US, Inc.. (G) Production of (G) Genetically
a chemical modified
substance. microorganism
for the
production of a
chemical
substance.
P-21-0088..................... 4 04/18/2022 Solepoxy, Inc.... (G) Molding (G) Heterocyclic
compound. epoxide polymer
with mixed
substituted
glycols and
acid anhydride.
P-21-0191A.................... 3 04/11/2022 Santolubes (S) This product (S) Fatty acids,
Manufacturing, will be used in C18-unsatd.,
LLC. gear oils & dimers,
greases, wind hydrogenated,
turbines, HX-1 polymers with
(incidental food polyethylene
contact) glycol,
lubricants and dihexanoates.
EV (Electric
Vehicle) motors.
It will be used
by OEMs in these
applications as
components in
finished
formulations.
The intended use
of these
products is 100%
industrial and
not intended for
use as consumer
products.
P-21-0199A.................... 5 04/18/2022 CBI.............. (G) Processing (G) 1,6-
aid. Disubstituted
hexane.
P-22-0059..................... 2 04/13/2022 CBI.............. (S) Use of enzyme (S)
in laundry and Thermomycolin,
dishwashing fermented, from
detergents. a modified
Trichoderma
reesei.
P-22-0060..................... 1 03/31/2022 CBI.............. (G) Intermediate. (G) Polyol allyl
ether,
homopolymer
terpene ether.
P-22-0061..................... 1 03/31/2022 CBI.............. (G) Intermediate. (G) Polyol allyl
ether,
homopolymer,
alkyl ethers.
P-22-0062..................... 1 04/01/2022 Vertellus (G) Fuel and Oil (G) Alkene,
Specialties, Inc. additive for heterocycle.
consumer,
industrial, and
commercial
applications.
P-22-0063..................... 1 04/01/2022 Vertellus (G) Fuel and Oil (G) Alkene,
Specialties, Inc. additive for heterocycle.
consumer,
industrial, and
commercial
applications.
P-22-0064..................... 1 04/01/2022 CBI.............. (G) Intermediate. (G) Polyol allyl
ether, polymer
with alkylene
oxides, terpene
ether.
P-22-0065..................... 1 04/01/2022 CBI.............. (G) Intermediate. (G) Polyol allyl
ether, polymer
with alkylene
oxides, alkyl
ethers.
P-22-0066..................... 2 04/26/2022 CBI.............. (G) Additive for (G) Polyol allyl
adhesives and ether, polymer
coatings. with alkylene
oxides, terpene
ether sulfate,
ammonium salt.
P-22-0067..................... 2 04/26/2022 CBI.............. (G) Additive for (G) Polyol allyl
adhesives and ether, polymer
coatings. with alkylene
oxides, alkyl
ether sulfate,
ammonium salts.
[[Page 31885]]
P-22-0069..................... 1 04/08/2022 CBI.............. (G) Component in (G)
battery. fluoroheteroaci
d, metal salt.
P-22-0070..................... 2 04/20/2022 CBI.............. (G) Dispersant (G)
polymer for Alkylaromatic
coatings. sulfonic acid,
alkyl ester,
compds. with
phenol-
formaldehyde
polymer with
amino-
polyethylene-
polypropylene
glycol-oxirane
copolymer and
benzoates.
P-22-0071..................... 2 04/14/2022 Lamberti USA, Inc (G) Industrial (S) D-
Surfactant. Glucopyranose,
oligomeric,
maleates, C9-11-
branched and
linear alkyl
glycosides,
sulfonated,
potassium
salts.
P-22-0072..................... 2 04/14/2022 Lamberti USA, Inc (G) Industrial (S) D-
Surfactant. Glucopyranose,
oligomeric,
maleates, decyl
octyl
glycosides,
sulfonated,
potassium
salts.
P-22-0073..................... 2 04/14/2022 Lamberti USA, Inc (G) Industrial (S) D-
Surfactant. Glucopyranose,
oligomeric,
maleates, C10-
16-alkyl
glycosides,
sulfonated,
potassium
salts.
P-22-0076..................... 1 04/13/2022 Earth Science (S) PABP-P will (S) Phosphoric
Laboratories HQ. be used as a acid, ammonium
carrier in salt (1:?).
agricultural
(non-pesticide)
micronutrient
products. To
formulate
corrosion
control products
used to minimize
corrosion of
steel pipes in
industrial water
towers.
P-22-0082..................... 1 04/25/2022 CBI.............. (G) Component of (G) Alkenoic
photoresist. acid, alkyl,
carbopolycyclic
alkyl ester,
polymer with
trihalo
(trihaloalkyl)
alkyl alkyl
alkenoate.
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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 04/01/2022 to 04/30/2022
----------------------------------------------------------------------------------------------------------------
Commencement If amendment, type of
Case No. Received date date amendment Chemical substance
----------------------------------------------------------------------------------------------------------------
P-16-0150A........................ 04/04/2022 11/29/2018 Revised generic name. (G)
Chlorofluoroalkane.
P-16-0532A........................ 03/30/2022 04/17/2019 Revised generic name. (G) Carboxylic acid
substituted lactam.
P-18-0013A........................ 04/21/2022 06/30/2021 Revised generic name. (G) Sulfonium,
phenolcarbopolycycle
, inner salt.
P-18-0257......................... 04/22/2022 04/20/2022 N.................... (S) Phosphoric acid,
potassium salt
(2:3).
P-19-0147A........................ 04/29/2022 01/29/2021 Revised generic name. (G) Polyethylene
glycol alkyl ether,
alkyl ester.
P-19-0165......................... 04/12/2022 03/15/2022 N.................... (G) Tall-oil pitch,
fraction, sterol-
low.
P-20-0010......................... 04/08/2022 03/31/2022 N.................... (G) Thio organic
substituted metal
salt.
P-21-0201......................... 04/20/2022 04/19/2022 N.................... (G) Tetradecyl
diamine pentamethyl
dichloride.
P-21-0201......................... 04/20/2022 04/19/2022 N.................... (G) Oleyl diamine
pentamethyl
dichloride.
[[Page 31886]]
P-21-0201......................... 04/20/2022 04/19/2022 N.................... (G) Hexadecyl diamine
pentamethyl
dichloride.
P-21-0201......................... 04/20/2022 04/19/2022 N.................... (G) Octadecyl diamine
pentamethyl
dichloride.
P-21-0206......................... 04/22/2022 03/28/2022 N.................... (G) Alkanes, branched
and linear.
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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 04/01/2022 to 04/30/2022
----------------------------------------------------------------------------------------------------------------
Case No. Received date Type of test information Chemical substance
----------------------------------------------------------------------------------------------------------------
P-14-0712............................... 04/19/2022 Polychlorinated (S) Waste plastics,
Dibenzodioxins and pyrolyzed, C5-55
Polychlorinated fraction.
dibenzofurans Testing.
P-16-0543............................... 04/19/2022 Exposure Monitoring Report (G) Halogenophosphoric
acid metal salt.
P-20-0014............................... 04/04/2022 Acute Inhalation Toxicity (G) Sugars, polymer with
Testing (OECD Test alkanetriamine.
Guideline 403).
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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: May 18, 2022.
Pamela Myrick,
Director, Project Management and Operations Division, Office of
Pollution Prevention and Toxics.
[FR Doc. 2022-11184 Filed 5-24-22; 8:45 am]
BILLING CODE 6560-50-P
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