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 Environmental Protection Agency [EPA-HQ-OPPT-2020-0077; FRL-10016-83]
 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 
                        ( print page 81201)
                        under EPA review or have recently concluded review. This document covers the period from 10/01/2020 to 10/31/2020.
 DATES: Comments identified by the specific case number provided in this document must be received on or before January 14, 2021.
 ADDRESSES: Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2020-0077, and the specific case number for the chemical substance related to your comment, by one of the following methods: *Federal eRulemaking Portal: 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.
                    *Mail:*
                         Document Control Office (7407M), Office of Pollution Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001.
                    *Hand Delivery:*
                         To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at 
                        *http://www.epa.gov/​dockets/​contacts.html.* 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, Information Management 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: 
                        *rahai.jim@epa.gov.* *For general information contact:*
                         The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 554-1404; email address: 
                        *TSCA-Hotline@epa.gov.*


SUPPLEMENTARY INFORMATION: I. Executive Summary A. What action is the Agency taking? This document provides the receipt and status reports for the period from 10/01/2020 to 10/31/2020. 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*. 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 
                    ( print page 81202)
                    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 10/01/2020 to 10/31/2020
Case No.
Version
Received date
Manufacturer
Use
Chemical substanceP-17-0301A
5
10/06/2020
CBI
(G) Used as a surface drier in clear and pigmented coatings systems to replace other primary driers, particularly cobalt
(G) Manganese heterocyclic-amine carboxylate complexes.P-18-0175A
9
10/01/2020
Hexion Inc
(S) Food can coating Non-food contact can coating
(S) Formaldehyde, polymer with 4-(1,1-dimethylethyl)phenol and phenol, Bu ether.P-18-0301A
2
10/01/2020
CBI
(G) Coating component
(G) Alkanedioic acid, polymer with cycloalkyl dimethanol, alkyl and cycloalkyl diisocyanates, dimethyl-alkanediol, dihydroxyalkanoic acid methylenebis[isocyanatocyclohexane, hydroxyethyl acrylate- and polyalkyl glycol monoalkyl ether blocked.P-18-0349A
5
10/05/2020
Lanxess Solutions US, Inc
(S) Two component adhesives and protective coatings for marine, infrastructure, etc. The urethane prepolymer is designed to react with epoxy materials to create a flexible coating or adhesive
(S) Oxirane, 2-methyl-, polymer with oxirane, ether with 1,2,3-propanetriol (3:1), polymer with 2,4-diisocyanato-1-methylbenzene, branched 4-nonylphenol-blocked.P-18-0383A
4
10/01/2020
CBI
(G) Coatings and inks for commercial use
(G) Dialkyl-alkanediamine, polymer with [(oxo-alkenyl)oxy]poly(oxy-alkanediyl)ether with bis(hydroxyalkyl)-alkanediol.P-19-0011A
7
10/16/2020
Shin etsu Silicones of America
(G) Additive to the EPDM rubber compounds
(G) Polysulfides, bis[3-(trialkoxysilyl)propyl].P-19-0082A
4
10/06/2020
Bedoukian Research Inc
(S) Fragrance uses per FFDCA: Fine fragrance, creams, lotions, etc, Fragrance uses per TSCA: Scented papers, candles, detergents, cleaners, etc
(S) Heptanal, 6-hydroxy-2,6-dimethyl-.P-19-0167A
5
10/09/2020
Santolubes Manufacturing, LLC
(S) synthetic engine, gear and lubricating oils and greases
(S) Poly(oxy-1,4-butanediyl), alpha-hydro-omega-hydroxy-, hexanoate.P-20-0001A
5
10/09/2020
Santolubes Manufacturing, LLC
(S) Synthetic engine, gear & lubricating oils & greases
(S) Poly(oxy-1,4-butanediyl), alpha-hydro-w-hydroxy-, nonanoate.P-20-0010A
10
10/14/2020
CBI
(G) Polymerization auxiliary
(G) Carboxylic acid, reaction products with metal hydroxide, inorganic dioxide and metal.P-20-0014A
2
10/06/2020
McTron Technologies
(G) Water resistant resin additive, Heat resistant binder additive
(G) Sugars, polymer with alkanetriamine.P-20-0046A
5
10/07/2020
CBI
(G) Catalyst
(G) Reaction products of alkyl-terminated alkylalumuminoxanes and {[(pentaalkylphenyl-(pentaalkylphenyl)amino)alkyl]alkanediaminato}bis(aralkyl) transition metal coordination compound.P-20-0046A
6
10/27/2020
CBI
(G) Catalyst
(G) Reaction products of alkyl-terminated alkylalumuminoxanes and {[(pentaalkylphenyl-(pentaalkylphenyl)amino)alkyl]alkanediaminato}bis(aralkyl) transition metal coordination compound.P-20-0048A
5
10/07/2020
CBI
(G) Catalyst
(G) Reaction products of alkyl-terminated alkylaluminoxanes and dihalogeno(alkylcyclopentadienyl)(tetraalkylcyclopentadienyl)transition metal coordination compound.( print page 81203)P-20-0048A
6
10/27/2020
CBI
(G) Catalyst
(G) Reaction products of alkyl-terminated alkylaluminoxanes and dihalogeno(alkylcyclopentadienyl)(tetraalkylcyclopentadienyl)transition metal coordination compound.P-20-0049A
5
10/07/2020
CBI
(G) Catalyst
(G) Reaction products of alkyl-aluminoxanes and bis(alkylcyclodialkylene)dihalogenozirconium.P-20-0049A
6
10/27/2020
CBI
(G) Catalyst
(G) Reaction products of alkyl-aluminoxanes and bis(alkylcyclodialkylene)dihalogenozirconium.P-20-0061A
4
10/13/2020
Allnex USA Inc
(S) Coating resin crosslinking agent
(G) Formaldehyde, polymer with alkylphenols, alkyl ether.P-20-0085A
7
09/30/2020
Luna Innovations Incorporated
(S) Fluid resistant coatings
(G) Bis(triethoxysilylpropyl carbamate) perfluoropolyether.P-20-0098A
4
10/21/2020
CBI
(S) property modifier for polymers
(G) Calcium cycloalkylcarboxylate.P-20-0102A
3
10/01/2020
Novihum Technologies, Inc
(S) Fertilizer/Soil amendment
(S) Chemical Abstract (CA) index name: Coal, brown, ammoxidized.P-20-0102A
4
10/08/2020
Novihum Technologies, Inc
(S) Fertilizer/Soil amendment
(S) Chemical Abstract (CA) index name: Coal, brown, ammoxidized.P-20-0118A
3
10/26/2020
CBI
(G) Additive in household consumer products.
(S) Pyridine, 4-methyl-2-pentyl-P-20-0138
3
10/14/2020
Gurit (USA) Inc
(S) The substance is part of a mixture with other amines to act as a curative for a 2-part epoxy adhesive formulation. The new substance will be used within an adhesive formulation for use within an industrial setting primarily but not limited to industries such as marine, automotive and wind energy. The adhesive is “cured” at either ambient conditions or using heat and a chemical reaction occurs forming a solid composite structure
(G) Alkane diglycidy ether, polymer with alkyl-cycloalkane diamines.P-20-0143A
3
10/22/2020
CBI
(S) Binder for Thermoplastic Coatings, Binder or Ink/Adhesive
(S) Cyclohexanemethanamine, 5-amino-1,3,3-trimethyl-, polymer with a-hydro-w-hydroxypoly(oxy-1,4-butanediyl), 5-isocyanato-1-(isocyanatomethyl)-1,3,3-trimethylcyclohexane and 1,1-methylenebis[4-isocyanatobenzene].P-20-0167A
3
10/22/2020
W.R. Grace & CO.—Conn
(G) Catalyst
(G) Phenylene, alkyl and polycarbomonocycle substituted, 1,2-dicarboxylate.P-20-0174A
4
10/16/2020
P2 Science, Inc
(S) For use in consumer products, as well as direct addition to consumer products. Specific functions would be as solubilizer, rheology modifier and fragrance oil
(S) 6-Octen-1-ol, 3,7-dimethyl-, homopolymer, monoacetate.P-20-0184A
2
10/16/2020
P2 Science, Inc
(S) For use in fragrances for consumer products, as well as direct addition to consumer products. Specific functions would be as solubilizer, rheology modifier and fragrance oil
(S) 6-Octen-1-ol, 3,7-dimethyl-, homopolymer.P-20-0185
3
10/08/2020
Designer Molecules, Inc
(G) Dielectric film forming material for use in microelectronic assembly applications
(S) Amines, C36-alkylenedi-, polymers with bicyclo[2.2.1]heptanedimethanamine, [5,5'-biisobenzofuran]-1,1',3,3'-tetrone and 3a,4,5,7a-tetrahydro-7-methyl-5-(tetrahydro-2,5-dioxo-3-furanyl)-1,3-isobenzofurandione, maleated.P-21-0001
1
10/01/2020
CBI
(G) Flame retardant
(S) Phosphinic acid, aluminum salt (3:1).P-21-0002
2
10/08/2020
CBI
(G) Polymer in coatings and ink
(G) Octadecanoic acid, 12-hydroxy-, polymer with aziridine, 2-oxepanone and tetrahydro-2H-pyran-2-one, reaction products with disubstituted heteropolycycle.P-21-0006
1
10/21/2020
CBI
(G) The PMN Substance is used in froth flotation to treat rare earth minerals and to remove deleterious substances
(G) Naphthalene derivative.SN-19-0002A
6
10/14/2020
CBI
(G) Friction and wear stabilizer in certain solid composite articles
(G) Potassium Titanate.* 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.
                    ( print page 81204) Table II—NOCs Approved * From 10/01/2020 to 10/31/2020
Case No.
Received date
Commencement date
If amendment, type of amendment
Chemical substanceP-16-0449
10/01/2020
09/28/2020
N
(S) 2,7-decadienal, (2e,7z)-.P-16-0539
10/07/2020
09/17/2020
N
(G) Organic sulfonate compound.P-18-0234A
10/20/2020
12/09/2019
CBI Substantiation provided
(G) Alkenoic acid, reaction products with bis substituted alkane and ether polyol.P-18-0310
10/20/2020
10/12/2020
N
(S) Benzenepropanoic acid, 3-(2h-benzotriazol-2-yl)-5-(1,1-dimethylethyl)-4-hydroxy-, 2,2-bis(hydroxymethyl)butyl ester.P-18-0359
10/20/2020
10/14/2020
N
(S) Ethene, 1-[difluoro(trifluoromethoxy)methoxy]-1,2,2-trifluoro-, polymer with 1,1-difluoroethene.P-18-0376
10/26/2020
10/15/2020
N
(G) Thiosulfuric acid, aminoalkyl ester.P-18-0382
10/20/2020
10/06/2020
N
(G) Xanthylium, bis[dicarboxycyclic]sulfonylamino-alkylcyclicamino-disulfo-sulfocyclic-, inner salt, monocationic salt.P-18-0393
10/23/2020
10/22/2020
N
(G) Alkenoic acid, alkyl, alkyl ester, polymer with alkyl propenoate, vinyl carbomonocyle, substituted alkyl propenoate, alkyl 2-alkyl 2-propenoate, alkanediol mono(2-alkyl-2-propenoate) and bicarbomonocylo alkyl 2-alkyl-2-alkenoate, tertiary alkyl substituted alkane peroxoate initiated.P-18-0405
09/29/2020
09/27/2020
N
(S) Phenol, 4,4'-(1-methylethylidene)bis-, polymer with 3,6,9,12-tetraoxatetradeca-1,13-diene, glycidyl ether.P-20-0011
10/20/2020
10/12/2020
N
(G) Tetraoxaspiro[5.5]alkyl-3,9-diylbis(alkyl-2,1-diyl) bis(2-cyano-3-(3,4-dimethoxyphenyl)acrylate).P-20-0035
10/20/2020
10/06/2020
N
(G) Substituted aromatic, 3,3'-[[6-[(substituted alkyl amino)]-1,3,5-triazine-2,4-diyl]bis[imino[2-(substituted)-5-[substituted alkoxy]-4,1-phenylene]-2,1- diazenediyl]]bis[substituted, sodium salt].P-20-0061
10/27/2020
10/25/2020
N
(G) Formaldehyde, polymer with alkylphenols, alkyl ether.P-20-0066
10/29/2020
10/29/2020
N
(G) 2-propenoic acid, 2-hydroxyethyl ester, reaction products with dialkyl hydrogen heterosubstituted phosphate and dimethyl phosphonate.* 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 10/01/2020 to 10/31/2020
Case No.
Received date
Type of test information
Chemical substanceP-14-0712
10/02/2020
Quarterly PCDD/F Test of PMN Substance using EPA Test Method 8290A
(G) Plastics, wastes, pyrolyzed, bulk pyrolysate.P-16-0543
10/13/2020
Exposure Monitoring Report
(G) Halogenophosphoric acid metal salt.P-17-0345
10/08/2020
Physical Chemical Properties Report (OECD Test Guideline 104 and 122; EC Methods A.9, A.14, A.15 and A.21), Acute Dermal Irritation (OECD Test Guideline 404), Acute Eye Irritation (OECD Test Guideline 405), Skin Sensitization, LLNA (OECD Test Guideline 422B), Acute Oral Toxicity (OECD Test Guideline 423), and Bacterial Reverse Mutation Assay (OECD Test Guideline 471)
(G) Polyurethane, methacrylate blocked.P-18-0154
10/12/2020
Algal Toxicity (OECD Test Guideline 201), Acute Oral Toxicity Study in Rats (OECD Test guideline 423), and Water Extractability Study. All test submitted on analog data
(G) Isocyanic acid, polyalkylenepolycycloalkylene ester, 2-alkoxy alkanol and 1-alkoxy alkanol and alkylene diol blocked.P-20-0066
09/29/2020
Reproductive/development Toxicity Screening Study in the Han Wistar Rat by Oral Gavage Administration
(G) 2-propenoic acid, 2-hydroxyethyl ester, reaction products with dialkyl hydrogen heterosubstituted phosphate and dimethyl phosphonate.P-20-0162
10/07/2020
Acute Oral Toxicity Study in Rats (OCED Test Guideline 420) and Bacterial Reverse Mutation Test (Ames Assay, OECD Test Guideline 471)
(G) Substituted, triaryl-, 3-substituted-2-substituted alkyl tricycloalkane-1-carboxylate (1:1).P-20-0162
10/07/2020
Acute Oral Toxicity Study in Rats (OCED Test Guideline 420) and Bacterial Reverse Mutation Test (Ames Assay, OECD Test Guideline 471)
(G) Sulfonium, triaryl-, 3,3,3-trihalo-2-sulfoalkyl polycycloalkane-1-carboxylate (1:1).
 
 
 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 12, 2020. Pamela Myrick, Director, Information Management Division, Office of Pollution Prevention and Toxics.


[FR Doc. 2020-27540 Filed 12-14-20; 8:45 am] BILLING CODE 6560-50-P