Certain New Chemicals; Receipt and Status Information for February 2022

CourtEnvironmental Protection Agency
Record Number2022-05656
Published date17 March 2022
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]
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                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.
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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
                [[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
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                 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 cb1.
                 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
                

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