Certain New Chemicals; Receipt and Status Information for February 2022
| Published date | 17 March 2022 |
| Citation | 87 FR 15237 |
| Record Number | 2022-05656 |
| Section | Notices |
| Court | Environmental Protection Agency |
Federal Register, Volume 87 Issue 52 (Thursday, March 17, 2022)
[Federal Register Volume 87, Number 52 (Thursday, March 17, 2022)]
[Notices]
[Pages 15237-15240]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-05656]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2022-0132; FRL-9411-04-OSCPP]
Certain New Chemicals; Receipt and Status Information for
February 2022
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
-----------------------------------------------------------------------
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
[[Page 15238]]
concluded review. This document covers the period from 02/01/2022 to
02/28/2022.
DATES: Comments identified by the specific case number provided in this
document must be received on or before April 18, 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, through the Federal
eRulemaking Portal at https://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 https://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 (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
What action is the Agency taking?
This document provides the receipt and status reports for the
period from 02/01/2022 to 02/28/2022. 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: https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/status-pre-manufacture-notices. This information is updated on a
weekly basis.
B. What is the Agency's authority for taking this action?
Under the Toxic Substances Control Act (TSCA), 15 U.S.C. 2601 et
seq., a chemical substance may be either an ``existing'' chemical
substance or a ``new'' chemical substance. Any chemical substance that
is not on EPA's TSCA Inventory of Chemical Substances (TSCA Inventory)
is classified as a ``new chemical substance,'' while a chemical
substance that is listed on the TSCA Inventory is classified as an
``existing chemical substance.'' (See TSCA section 3(11).) For more
information about the TSCA Inventory please go to: https://www.epa.gov/tsca-inventory.
Any person who intends to manufacture (including import) a new
chemical substance for a non-exempt commercial purpose, or to
manufacture or process a chemical substance in a non-exempt manner for
a use that EPA has determined is a significant new use, is required by
TSCA section 5 to provide EPA with a PMN, MCAN or SNUN, as appropriate,
before initiating the activity. EPA will review the notice, make a risk
determination on the chemical substance or significant new use, and
take appropriate action as described in TSCA section 5(a)(3).
TSCA section 5(h)(1) authorizes EPA to allow persons, upon
application and under appropriate restrictions, to manufacture or
process a new chemical substance, or a chemical substance subject to a
significant new use rule (SNUR) issued under TSCA section 5(a)(2), for
``test marketing'' purposes, upon a showing that the manufacture,
processing, distribution in commerce, use, and disposal of the chemical
will not present an unreasonable risk of injury to health or the
environment. This is referred to as a test marketing exemption, or TME.
For more information about the requirements applicable to a new
chemical go to: http://www.epa.gov/oppt/newchems.
Under TSCA sections 5 and 8 and EPA regulations, EPA is required to
publish in the Federal Register certain information, including notice
of receipt of a PMN/SNUN/MCAN (including amended notices and test
information); an exemption application under 40 CFR part 725 (biotech
exemption); an application for a TME, both pending and concluded; NOCs
to manufacture a new chemical substance; and a periodic status report
on the new chemical substances that are currently under EPA review or
have recently concluded review.
C. Does this action apply to me?
This action provides information that is directed to the public in
general.
D. Does this action have any incremental economic impacts or paperwork
burdens?
No.
E. What should I consider as I prepare my comments for EPA?
1. Submitting confidential business information (CBI). Do not
submit this information to EPA through regulations.gov or email.
Clearly mark the part or all of the information that you claim to be
CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark
the outside of the disk or CD-ROM as CBI and then identify
electronically within the disk or CD-ROM the specific information that
is claimed as CBI. In addition to one complete version of the comment
that includes information claimed as CBI, a copy of the comment that
does not contain the information claimed as CBI must be submitted for
inclusion in the public docket. Information so marked will not be
disclosed except in accordance with procedures set forth in 40 CFR part
2.
2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.
I. 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
[[Page 15239]]
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 02/01/2022 to 02/28/2022
----------------------------------------------------------------------------------------------------------------
Received
Case No. Version date Manufacturer Use Chemical substance
----------------------------------------------------------------------------------------------------------------
J-22-0008A........... 3 02/15/2022 CBI.............. (G) Manufacture of an (G) Modified Yeast.
alcohol.
J-22-0011A........... 2 01/28/2022 CBI.............. (G) Ethanol production (G) Biofuel producing
Saccharomyces
cerevisiae modified,
genetically stable.
P-16-0218A........... 7 02/03/2022 CBI.............. (G) Reactant: Spray (G) Acetoacetylated
Foam Insulation, Glycerin.
Architectural Coating.
P-20-0124A........... 4 02/18/2022 CBI.............. (G) Additive in (S) 5-octen-4-ol, 3,5-
Household consumer dimethyl-, (5E)-.
products.
P-20-0126A........... 4 02/18/2022 CBI.............. (G) Additive in (S) 4-Decenal, 5,9-
household consumer dimethyl-.
products.
P-21-0011A........... 3 02/01/2022 CBI.............. (S) Crosslinking agent (G) Hexane, 1,6-
for inks and coatings. diisocyanato-,
homopolymer, alkyl
epoxy ether- and
polyethylene glycol
mono-Me ether-
blocked, reaction
products with
propylenimine.
P-21-0082A........... 2 02/18/2022 CBI.............. (G) Additive in (S) 1-Decen-4-yne.
household consumer
products.
P-21-0205A........... 2 02/18/2022 CBI.............. (G) Additive in (S) Benzene, [2-[(2-
household consumer methyl-1-undecen-1-
products. yl{time} oxy]ethyl]-.
P-21-0206A........... 3 02/18/2022 HollyFrontier (G) Component of (G) Alkanes, branched
Corporation. gasoline. and linear.
P-22-0017A........... 2 02/01/2022 Sasol Chemicals (S) Paraffin wax (S) 1-Eicosanol,
(USA), LLC. substitute for manuf. of, distn.,
candles, Alkylate for residues.
polymer esters.
P-22-0036............ 2 02/07/2022 Torrecid USA, LLC (S) coloring agent, (S) chromium iron
pigment for master manganese oxide.
batch.
P-22-0037............ 1 02/03/2022 Allnex USA, Inc.. (S) Additol XL 186 is (G) Polyphosphoric
a specific, high acids, esters with
efficiency additive heteromonocycle
which improves the homopolymer.
adhesion to metal,
especially under
humid conditions.
P-22-0039............ 2 02/25/2022 CBI.............. (S) Colorant for (G) Poly(oxy-1,2-
agricultural ethanediyl),alpha,alp
applications. ha'-[[[4-(4-alkyl
heteroaryl)ene]aryl]i
mino]di-2,1-
ethanediyl]bis[omega-
hydroxy-].
P-22-0040............ 1 02/07/2022 CBI.............. (G) Component used in (S) Manganate(4-),
manufacture of high hexakis(cyano-
performance batteries. .kappa.C)-, manganese
(2+) sodium, (OC-6-
11)-.
P-22-0041............ 1 02/07/2022 CBI.............. (G) A component used (S) Ferrate (-4),
in the manufacture of hexakis(cyano-
batteries. .kappa.C)-, iron(3+)
manganese(2+) sodium,
(OC-6-11)-.
P-22-0042............ 1 02/09/2022 CBI.............. (G) Photolithography.. (G) Alkanedione,
[[[(substituted)aryl]
thio]aryl]-, 2-(O-
acetyloxime).
P-22-0044............ 1 02/15/2022 CBI.............. (G) Site Limited (G) Silica gel,
Intermediate. reaction products
with alkyl metal
salt.
P-22-0045............ 1 02/15/2022 AkzoNobel........ (G) Polymer used in (G) Fatty acids,
the manufacture of polymer with modified
paint. benzofuran-1,3-dione,
pentaerythritol and
aromatic acid
anhydride.
P-22-0047............ 2 02/25/2022 CBI.............. (G) Epoxy additive.... (G) Alkyl substituted
carbopolycyclic acids
and heteromonocyclic
esters.
P-22-0048............ 2 02/24/2022 Ashland, Inc..... (S) Intermediate in (G) halogenated
film. dodecyl-acetylen.
SN-22-0001A.......... 2 01/28/2022 CBI.............. (G) Component in (S) Ethanol, 2,2',2''-
polishing formulation. nitrilotris-, compd.
with .alpha.-[2,4,6-
tris(1-
phenylethyl)phenyl]-
.omega.-
hydroxypoly(oxy-1,2-
ethanediyl)
phosphate.
----------------------------------------------------------------------------------------------------------------
* The term `Approved' indicates that a submission has passed a quick initial screen ensuring all required
information and documents have been provided with the submission prior to the start of the 90 day review
period, and in no way reflects the final status of a complete submission review.
[[Page 15240]]
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 02/01/2022 to 02/28/2022
----------------------------------------------------------------------------------------------------------------
If amendment,
Case No. Received date Commencement type of Chemical substance
date amendment
----------------------------------------------------------------------------------------------------------------
J-22-0001..................... 02/22/2022 02/15/2022 N (G) Chromosomally-modified
saccharomyces cerevisiae.
J-22-0002..................... 02/22/2022 01/31/2022 N (G) Chromosomally-modified
saccharomyces cerevisiae.
P-15-0694..................... 02/24/2022 02/21/2022 N (S) Phenol, polymer with
formaldehyde, glycidyl
ether, polymers with 1,3-
benzenedimethanamine,
reaction products with 2-
[(c12-14-
alkyloxy)methyl]oxirane.
P-17-0198..................... 02/22/2022 02/07/2022 N (S) Neodymium, chloro et
hydro iso-bu neodecanoate
polybutadiene aluminum
complexes.
P-18-0170..................... 02/23/2022 02/23/2022 N (S) 1-propanaminium, n,n'-
(oxydi-2,1-ethanediyl)bis[3-
chloro-2-hydroxy-n,n-
dimethyl-, dichloride.
P-19-0010..................... 01/31/2022 01/27/2022 N (G) Hydrogenated fatty acid
dimers, polymers with 1,1'-
methylenebis[4-
isocyanatobenzene],
polypropylene glycol,
polypropylene glycol ether
with trimethylolpropane
(3:1), and 1,3-propanediol,
propylene glycol
monomethacrylate-blocked.
P-19-0052..................... 02/03/2022 06/03/2020 N (S) Poly(oxy-1,2-ethanediyl),
alpha-nonyl-omega-hydroxy-,
branched and linear.
P-19-0158..................... 02/15/2022 02/08/2022 N (G) Alkenoic acid polymer
with 2-ethyl-2-
(hdroxymethyl)-1,3-
alkyldiol, 1,1'-
methylenebis(4-
isocyantocarbomonocycle) and
3-methyl-1,5-aklydiol.
P-21-0005..................... 02/11/2022 01/20/2022 N (G) Carbonmonocyclic alkene
polymer with alkyl
alkenoate, alkyl alkenoate,
alkyl alkenoate and
polyalkyldiene alkenoate.
P-21-0094..................... 02/08/2022 01/22/2022 N (G) Silane, halogenated.
P-21-0135..................... 02/09/2022 02/06/2022 N (G) Alkenoic acid, allyl-,
(dialkylamino)alkyl ester,
polymer with dialkyl-
alkylene-
alkanediyl)bis[carbomoncycle
], alkylalkyl alkyl-
alkenoate and alkanediol
mono(2-alkyl-alkenoate),
diazenediyl)bis[2-
alkylalkanenitrile]-
initiated.
P-21-0186..................... 02/09/2022 01/18/2022 N (G) Glycerin, alkoxylated
alkyl acid esters.
----------------------------------------------------------------------------------------------------------------
* 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 02/01/2022 to 02/28/2022
------------------------------------------------------------------------
Type of test Chemical
Case No. Received date information substance
------------------------------------------------------------------------
J-21-0020............ 02/09/2022 Complete vector (G) Sulfolobus
sequence with solfataricus-
annotations in strain ccb1.
FASTA format.
P-13-0021............ 02/23/2022 Hexafor 6240 (G)
polymer method Perfluoroacryl
validation of ate polymer.
TOP assay.
P-16-0289............ 02/17/2022 Particle size (G) Benzene
distribution dicarboxylic
analysis. acid, polymer
with alkane
dioic acid and
aliphatic
diamine.
P-16-0543............ 02/16/2022 Exposure (G)
monitoring Halogenophosph
report. oric acid
metal salt.
P-21-0176............ 02/23/2022 Skin (G) Alkane
Sensitization dioic acid,
(OECD Test bis (poly
Guideline 406). aromatic
triazine)
alkanoic ether
phenoxy ester.
------------------------------------------------------------------------
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: March 14, 2022.
Pamela Myrick,
Director, Project Management and Operations Division, Office of
Pollution Prevention and Toxics.
[FR Doc. 2022-05656 Filed 3-16-22; 8:45 am]
BILLING CODE 6560-50-P
