2021-20606. Certain New Chemicals; Receipt and Status Information for August 2021

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

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 08/01/2021 to 08/31/2021.

DATES:

Comments identified by the specific case number provided in this document must be received on or before October 25, 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, using 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: [phone]; email address: [e-mail].

For general information contact: The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone number: [phone]; email address: [e-mail].

SUPPLEMENTARY INFORMATION:

I. Executive Summary

A. What action is the Agency taking?

This document provides the receipt and status reports for the period from 08/01/2021 to 08/31/2021. 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 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.

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 08/01/2021 to 08/31/2021

Case No.	Version	Received date	Manufacturer	Use	Chemical substance
P-18-0289A	11	08/19/2021	Guard Products	(G) Gas scrubbing landfill deoderizing	(G) 2-(2(methylcaboxymonocyclic)amino)ethoxy)-alcohol.
P-18-0290A	11	08/19/2021	Guard Products	(G) Gas scrubbing, wastewater deoderizing	(G) Carbomonocylic-oxazolidine.
P-18-0326A	11	08/03/2021	CBI	(G) Chemical Intermediate	(G) Alkanoic acid, alkyl ester, manuf. of, byproducts from, distn. residues.
P-20-0058A	8	08/04/2021	CBI	(G) Additive for automatic dishwashing; Additive for hard surface cleaner	(G) Polysaccharide, polymer with unsaturated carboxylic acid and methacryloxyethyltrimethyl ammonium chloride, sodium salt, acid salt initiated.
P-21-0003A	4	08/30/2021	CBI	(G) Polymeric film former for coatings	(G) 4, 4 methylenebis (2, 6 dimethyl phenol) polymer with 2-(chloromethyl) oxirane, 1,4-benzene diol, 2-methyl-2-propenoic acid, mixed alkyl substituted 2-methyl 2-propenoate, and ethyl 2-propenoate, reaction products with 2-(dimthylamino) ethanol.
P-21-0049A	3	08/06/2021	CBI	(G) Monomer	(G) Alkanoic acid, polyhalo-(halo-oxo-alkenyl)oxyalkyl ester.
P-21-0049A	4	08/13/2021	CBI	(G) Monomer	(G) Alkanoic acid, polyhalo-(halo-oxo-alkenyl)oxyalkyl ester.
P-21-0050A	3	08/06/2021	CBI	(G) Monomer	(G) Alkenoic acid, halo-polylhaloalkyl ester.
P-21-0050A	4	08/13/2021	CBI	(G) Monomer	(G) Alkenoic acid, halo-polylhaloalkyl ester.
P-21-0056A	3	08/19/2021	CBI	(G) Component of coatings	(G) Isocyanic acid, polyalkylenepolyarylene ester, polymer with alkyl-hydroxyalkyl-alkanediol, alkoxyalcohol and alkoxylalkoxyalcohol-blocked.
P-21-0057A	3	08/19/2021	CBI	(G) Component in coatings	(G) Sulfur based acid, compound with aminoalkylalkyl-aminoalkylalkoxy-polyoxyalkylalkanediyl, polymer with haloalkyl-epoxide and alkylalkylidene-cycloarylalcohol.
P-21-0058A	3	08/19/2021	CBI	(G) Component in coatings	(G) Substituted alkanoic acid, compound with aminoalkylalkyl-aminoalkylalkoxy-polyoxyalkylalkanediyl, polymer with haloalkyl-epoxide and alkylalkylidene-cycloarylalcohol.
P-21-0060A	4	08/19/2021	CBI	(G) Isolated intermediate	(G) Bisphenol A epichlorohydrin polymer with alkylpolyalkene-polyarylene-hydroxypolyoxyalkyldiyl reaction products with alkylalkylidene-alkylalkylidene-aminoalkyl-alkanepolyamine and alkylaminoalkanol.
P-21-0061A	4	08/19/2021	CBI	(G) Component in coatings	(G) Sulfur based acid, compds. with modified bisphenol A-epichlorohydrin-polyalkylene polyol ether with bisphenol A polymer-N-dialkylalkylidene-N-(dialkylalklyidene)aminoalkyl-alkanepolyamine-alkylaminoalkanol reaction products.
P-21-0062A	4	08/19/2021	CBI	(G) Component in coatings	(G) Substituted-alkanoic acid, compds. with modified bisphenol A-epichlorohydrin-polyalkylene polyol ether with bisphenol A polymer-N-dialkylalkylidene-N-dialkylalkylideneaminoalkyl-alkanepolyamine-alkylaminoalkanol reaction products.
P-21-0078A	3	08/25/2021	Pinova, Inc.	(S) Tackifying additive used in tire manufacture; Tackifying additive used in hot melt adhesive applications (e.g., pressure sensitive adhesives, and graphic art applications such as bookbinding, magazine manufacture, and label making)	(G) Phenol, polymer with alkyl-(alkylalkylenyl)cyclohexene, mixed dialkylcyclohexadienes, mixed alkyl-(alkylalkylidene)cyclohexenes and 3,7,7-trimethylbicyclo[4.1.0]hept-3-ene.
P-21-0098A	4	08/26/2021	Hubergroup	(S) Co-initiator for the curing of UV printing inks	(G) Poly(oxy-1,2-ethanediyl), alpha-hydro-omega-[2(or 3)-[[substituted benzoyl]oxy]hydroxypropoxyl]-, alpha, alpha′, alpha″ -ether with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol (3:1).
P-21-0100A	2	08/17/2021	ENI Trading & Shipping Inc	(G) Used as a lubricant and lubricant additive (used in closed systems; non-dispersive use); Lubricant and lubricant additive (used in closed systems; non-dispersive use)	(G) Raffinates (petroleum), vacuum distillate solvent, solvent-dewaxed, hydrotreated.
P-21-0168A	2	08/10/2021	CBI	(G) Colorant	(G) Metal, [heteropolycyclic]-, [[[(hydroxyalkyl) amino]sulfonyl]alkyl]sulfonyl(sulfoalkyl)sulfonyl derivs., ammonium sodium salts.
P-21-0178	2	08/19/2021	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-21-0179	2	08/19/2021	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-21-0199	2	08/12/2021	Avery Dennison Mill Hall	(G) Processing aid	(G) 1,6-Disubstituted hexane.
P-21-0199A	3	08/18/2021	CBI	(G) Processing aid	(G) 1,6-Disubstituted hexane.
P-21-0200	1	08/02/2021	CBI	(G) Printing additive	(G) Saturated and unsaturated hydrocarbon waxes, oxidized, polymers with alkenoic acid, alkyl alkanoate, alkenedioic acid, polyalkylene glycol ether with substituted carbomonocycle (alkylidene)bis-, polyalkylene glycol ether with substituted carbomonocycle (alkylidene)bis-, substituted carbomonocycle, disubstituted carbomonocycle and substituted heteropolycycle, alkyl peroxide-initiated.
P-21-0202	1	08/04/2021	CBI	(G) An ingredient used in the manufacture of photoresist	(G) Sulfonium, carbomonocycle bis[(trihaloalkyl)carbomonocycle], substituted carbomonocyclic ester.
P-21-0203	3	08/10/2021	CBI	(G) Surfactant will be used in various applications in oil and gas industry	(G) Glycolipids, sophorose-contg., Starmerella bomicola-fermented, from sugar and vegetable oils.
P-21-0204	1	08/12/2021	CBI	(G) Photolithography	(G) Sulfonium, bis(3,4-polyhalocarbocyclic)aryl-, alpha, alpha, beta, beta-polyhalopolyhydro-2,2-diaryl-4,7-methano-1,3-heteropolycyclic-5-alkanesulfonate (1:1).
P-21-0205	1	08/13/2021	CBI	(G) Additive in household consumer products	(S) Benzene, [2-[(2-methyl-1-undecen-1-yl}oxy]ethyl]-.
P-21-0206	1	08/13/2021	HollyFrontier Corporation	(G) Component of gasoline	(G) Alkanes, branched and linear.
P-21-0207	2	08/18/2021	CBI	(G) Emulsifier	(G) Fatty alcohol ethoxylate, ethercarboxylate Branched and Linear, Fatty alcohol ethoxylate, ethercarboxylate.
P-21-0208	1	08/17/2021	CBI	(G) Adhesive for profile wrapping	(G) Aromatic diacids, polymer with alkyldiacids, alkyldiols, benzofurandione, caprolactone and 1,1′-methylenebis[4-isocyanatobenzene].
P-21-0209	1	08/17/2021	CBI	(G) Adhesive for profile wrapping	(G) Aromatic diacid, polymer with alkyldiacid, alkyldiols, polypropylene glycol, benzofurandione, caprolactone and 1,1′-methylenebis[4-isocyanatobenzene].
P-21-0210	1	08/17/2021	CBI	(G) Adhesive for profile wrapping	(G) Aromatic diacids, polymer with alkyldiacids, alkyldiols, benzofurandione, polypropylene, alkylhydroxyacid glycolester, caprolactone and 1,1′-methylenebis[4-isocyanatobenzene].
SN-21-0006	2	08/27/2021	Carbice	(S) For heat transfer, heat storage, thermal emission, and general temperature management in heat-generating systems such as electronics; Gap filling or sealing of opposing interfaces; For light absorption properties; To improve mechanical properties or electrical conductiveness of other materials or products	(S) Multiwalled carbon nanotubes grown perpendicularly on an aluminum foil substrate using Fe catalyst.
* 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 08/01/2021 to 08/31/2021

Case No.	Received date	Commencement date	If amendment, type of amendment	Chemical substance
P-08-0246	08/04/2021	06/13/2021	N	(S) Fatty acids, C8-10, mixed tetraesters with heptanoic acid, pentaerythritol, 3,5,5-trimethylhexanoic acid and valeric acid.
P-10-0495	08/20/2021	07/29/2021	N	(G) Poly(oxy-1,2-ethanediyl),. alpha., -monoalkyl ethers-.omega.-mono (hydrogen maleate)-.
P-11-0242	08/03/2021	07/09/2021	N	(G) Hydroxy-olefin.
P-15-0607	08/07/2021	07/26/2021	N	(G) 1,2,4,5,7,8-hexoxonane,3,6,9-trimethyl-,3,6,9-tris(alkyl) derivs.
P-17-0343A	08/19/2021	04/09/2018	Updated generic name	(G) Modified benzimidazole salt.
P-18-0267	08/24/2021	08/23/2021	N	(G) Branched alkanoic acid, epoxy ester, reaction products with monocyclicdialkanamine and polycyclic dialkanol ether polymer.
P-19-0028	08/18/2021	08/05/2021	N	(G) Alkyl salicylate, metal salts.
P-21-0051	08/25/2021	08/24/2021	N	(S) Fatty acids, C18-unsatd., dimers, hydrogenated, polymers with 2-hydroxyethyl-terminated hydrogenated polybutadiene, bis(2,5-dihydro-2,5-dioxo-1h-pyrrole-1-hexanoate).
P-21-0065	08/13/2021	08/12/2021	N	(G) Alkenoic acid, reaction products with alkylamine-alkanediyl diacrylate polymer and [oxybis(alkylene)]bis[alkyl-alkanediol].
P-21-0103	08/05/2021	08/02/2021	N	(S) Urea, N-[3-[[(4-methylphenyl)sulfonyl]oxy]phenyl]-N'-phenyl-.
* 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 08/01/2021 to 08/31/2021

Case No.	Received date	Type of test information	Chemical substance
P-14-0712	08/03/2021	Quarterly PCDD/F Test of PMN Substance using EPA Test Method 8290A	(G) Plastics, wastes, pyrolyzed, bulk pyrolysate.
P-18-0293	08/02/2021	Assessment of Acute Inhalation Toxicity with Dihexylmethylenemalonate in Wistar Han Rat (Nose Only) Study	(S) Propanedioic acid, 2-methylene-, 1,3-dihexyl ester.
P-21-0144	08/16/2021	Composition Data	(G) Naphtha, heavy catalytic cracked.
P-21-0148	08/16/2021	Composition Data	(G) Naphtha, light catalytic cracked.

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: September 17, 2021.

Pamela Myrick,

Director, Project Management and Operations Division, Office of Pollution Prevention and Toxics.