Environmental Protection Agency (EPA).
EPA is required under the Toxic Substances Control Act (TSCA), as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act, to make information publicly available and to publish information in the Federal Register pertaining to submissions under TSCA Section 5, including notice of receipt of a Premanufacture notice (PMN), Significant New Use Notice (SNUN) or Microbial Commercial Activity Notice (MCAN), including an amended notice or test information; an exemption application (Biotech exemption); an application for a test marketing exemption (TME), both pending and/or concluded; a notice of commencement (NOC) of manufacture (including import) for new chemical substances; and a periodic status report on new chemical substances that are currently under EPA review or have recently concluded review. This document covers the period from 11/01/2020 to 11/30/2020.
Comments identified by the specific case number provided in this document must be received on or before March 11, 2021.
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 Start Printed Page 8787Protection 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.
Start Further Info
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: firstname.lastname@example.org.
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.
End Further Info
Start Supplemental Information
I. Executive Summary
A. What action is the Agency taking?
This document provides the receipt and status reports for the period from 11/01/2020 to 11/30/2020. 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?
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 Start Printed Page 8788EPA'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 11/01/2020 to 11/30/2020
|Case No.||Version||Received date||Manufacturer||Use||Chemical substance|
|J-20-0005||2||10/16/2020||CBI||(G) Ethanol production||(G) Saccharomyces cerevisiae modified.|
|J-20-0013||3||10/27/2020||Greenlight Biociences, Inc||(G) Production of enzymes for use in internal manufacturing||(G) Modified strains of Escherichia coli.|
|J-20-0014||3||10/27/2020||Greenlight Biociences, Inc||(G) Production of enzymes for use in internal manufacturing||(G) Modified strains of Escherichia coli.|
|J-20-0015||3||10/27/2020||Greenlight Biociences, Inc||(G) Production of enzymes for use in internal manufacturing||(G) Modified strains of Escherichia coli.|
|J-20-0016||3||10/27/2020||Greenlight Biociences, Inc||(G) Production of enzymes for use in internal manufacturing||(G) Modified strains of Escherichia coli.|
|J-20-0017||3||10/27/2020||Greenlight Biociences, Inc||(G) Production of enzymes for use in internal manufacturing||(G) Modified strains of Escherichia coli.|
|J-20-0018||3||10/27/2020||Greenlight Biociences, Inc||(G) Production of enzymes for use in internal manufacturing||(G) Modified strains of Escherichia coli.|
|J-20-0025||3||11/03/2020||CBI||(G) Ethanol production||(G) Biofuel producing Saccharomyces cerevisiae modified, genetically stable.|
|P-18-0057A||12||11/12/2020||CBI||(S) a drier accelerator that is used for superior drying performance in solvent-borne and waterborne air-dried paints, inks and coatings||(G) Vanadium Carboxylate.|
|P-18-0057A||13||11/18/2020||CBI||(S) a drier accelerator that is used for superior drying performance in solvent-borne and waterborne air-dried paints, inks and coatings||(G) Vanadium Carboxylate.|
|P-18-0057A||14||11/23/2020||CBI||(S) a drier accelerator that is used for superior drying performance in solvent-borne and waterborne air-dried paints, inks and coatings||(G) Vanadium Carboxylate.|
|P-18-0084A||9||11/23/2020||ShayoNano USA, Inc||(S) Additive for water-based paints and coatings||(S) silicon zinc oxide.|
|P-18-0256A||7||11/11/2020||CBI||(G) Chemical Intermediate||(S) Undecanol, branched.|
|P-18-0293A||6||11/17/2020||CBI||(S) Monomer for use in emulsion polymers, formulated industrial coatings, industrial adhesives||(S) Propanedioic acid, 2-methylene-, 1,3-dihexyl ester.|
|P-18-0293A||7||11/20/2020||CBI||(S) Monomer for use in emulsion polymers, formulated industrial coatings, industrial adhesives||(S) Propanedioic acid, 2-methylene-, 1,3-dihexyl ester.|
|P-18-0294A||6||11/17/2020||CBI||(S) Monomer for use in emulsion polymers, formulated industrial coatings, industrial adhesives||(S) Propanedioic acid, 2-methylene-, 1,3-dicyclohexyl ester.|
|P-18-0294A||7||11/20/2020||CBI||(S) Monomer for use in emulsion polymers, formulated industrial coatings, industrial adhesive||(S) Propanedioic acid, 2-methylene-, 1,3-dicyclohexyl ester.|
|P-18-0345A||3||11/24/2020||Chitec Technology Co., Ltd||(S) R-gen 990 is a liquid aminoketone-based photoinitator (PI) intended for use as an ultraviolet (UV) curing agent in highly pigmented inks, photoresists, and masks||(S) 1-Butanone, 2-(dimethylamino)-1-[4-(2-ethyl-2-methyl-3-oxazolidinyl)phenyl]-2-(phenylmethyl)-.|
|Start Printed Page 8789|
|P-19-0082A||5||11/12/2020||Bedoukian Research Inc||(S) Fragrance uses per FFDCA: Fine fragrance, creams, lotions, etc., TSCA: Scented papers, candles, detergents, cleaners, etc||(S) Heptanal, 6-hydroxy-2,6-dimethyl-.|
|P-20-0010A||11||11/04/2020||CBI||(G) Polymerization auxiliary||(G) Carboxylic acid, reaction products with metal hydroxide, inorganic dioxide and metal.|
|P-20-0031A||5||11/02/2020||CBI||(G) Intermediate||(G) Perfluorinated substituted 1,3-oxathiolane dioxide.|
|P-20-0070A||2||11/07/2020||Clariant Corporation||(S) Solvent for use in formulated pesticide products||(S) Nonanamide, N,N-dimethyl-.|
|P-20-0076A||4||11/04/2020||Cytec Industries Inc||(G) Mining chemical||(S) Glycine, reaction products with sodium O-iso-Pr carbonodithioate, sodium salts.|
|P-20-0077A||6||11/23/2020||CBI||(S) UV Curing Agent for use in Inks and Coatings||(G) 1-(dialkyl-diphenylene alkane)-2-alkyl-2-hydrooxazine-1-alkylketone.|
|P-20-0078A||2||11/11/2020||Ascend Performance Materials||(G) Stabilizer for industrial applications||(G) Dicarboxylic acid, compd. with aminoalkyl-alkyldiamine alkyldioate alkyldioate (1:2:1:1).|
|P-20-0079A||2||11/11/2020||Ascend Performance Materials||(G) Stabilizer for industrial applications||(G) Dicarboxylic acid, compd. with aminoalkyl-alkyldiamine (3:2).|
|P-20-0080A||5||11/11/2020||Ascend Performance Materials||(G) Stabilizer for industrial applications||(G) Alkyldiamine, aminoalkyl-, hydrochloride (1:3).|
|P-20-0081A||5||11/11/2020||Ascend Performance Materials||(G) A stabilizer for industrial applications||(G) Carboxylic acid, compd. with aminoalkyl-alkyldiamine (3:1).|
|P-20-0082A||5||11/11/2020||Ascend Performance Materials||(G) Stabilizer for industrial applications||(G) Alkyldiamine, aminoalkyl-, carboxylate (1:3).|
|P-20-0094A||3||11/12/2020||CBI||(S) Formulation component in UV/EB coatings, inks and 3D printing/stereolithography/additive and adhesive manufacturing||(G) Alkanedioic acid, polymer with tri-alkyl-isocyanatocarbomonocycle, dialkylglycols, ester with 2,3-dihydroxypropyl alkyl ester, 2-hydroxyethyl methacrylate-blocked.|
|P-20-0105A||3||11/25/2020||Sound Agriculture Company||(S) Maltol lactone is a compound that promotes microbial activity in the soil, resulting in increased availability of phosphorus for crops. This substance will be used on commercial farming operations||(S) 4H-Pyran-4-one, 3-[(2,5-dihydro-4-methyl-5-oxo-2-furanyl)oxy]-2-methyl-.|
|P-20-0127A||4||11/12/2020||Kuraray America, Inc||(S) Industrial Solvent||(S) 2H-Pyran, tetrahydro-4-methyl-.|
|P-20-0138A||4||11/20/2020||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||(G) Alkane diglycidy ether, polymer with alkyl-cycloalkane diamines.|
|P-20-0146A||2||11/06/2020||CBI||(G) Insulating material for electrical parts||(G) Alkanoic acid, alkyl, carbopolycyclic alkyl ester.|
|P-20-0148||2||11/12/2020||Solugen Inc||(G) Additive for consumer, industrial, and commercial uses||(G) Hydroxyalkanoic acid, salt, oxidized.|
|P-20-0149||2||11/12/2020||Solugen Inc||(G) Additive for consumer, industrial, and commercial uses||(G) Hydroxyalkanoic acid, salt, oxidized.|
|P-20-0150||2||11/12/2020||Solugen, Inc||(G) Additive for consumer, industrial, and commercial uses||(G) Hydroxyalkanoic acid, salt, oxidized.|
|P-20-0151||2||11/12/2020||Solugen, Inc||(G) Additive for consumer, industrial, and commercial uses||(G) Hydroxyalkanoic acid, salt, oxidized.|
|P-20-0153A||4||11/04/2020||CBI||(G) lubricant additive—dispersant||(G) Polyamines, reaction products with succinic anhydride polyalkenyl derivs., borates.|
|P-20-0154A||4||11/04/2020||CBI||(G) lubricant additive—dispersant||(G) Polyamines, reaction products with succinic anhydride polyalkenyl derivs., borates.|
|P-20-0161A||2||11/04/2020||Sirrus, Inc||(S) Film former or crosslinker additive used in coatings, waterborne emulsions, adhesives||(S) Propanedioic acid, 2-methylene-, 1,3-diethyl ester, polymer with 1,4-butanediol.|
|Start Printed Page 8790|
|P-20-0169||3||11/23/2020||CBI||(G) Battery Plastics and coatings applications, Conductive agent for conductive plastic and paint||(S) multiwalled carbon nanotube.|
|P-20-0183A||2||11/16/2020||CBI||(G) Intermediate||(G) Aryl ether epoxide, homopolymer, ether with alkanolamine.|
|P-21-0003||3||11/04/2020||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-21-0004||3||11/11/2020||CBI||(G) Surfactant||(G) Poly alkyl glycol alkyl ether.|
|P-21-0011||2||11/04/2020||CBI||(S) Crosslinking agent for inks and coatings||(G) Hexane, 1,6-diisocyanato-, homopolymer, alkyl epoxy ether- and polyethylene glycol mono-Me ether-blocked, reaction products with propylenimine.|
|P-21-0012||1||10/28/2020||CBI||(G) The notified substance will be used as a fragrance ingredient||(G) Multialkylbicycloalkenyl substituted propanenitrile.|
|P-21-0013||2||11/24/2020||Takasago||(S) Fragrance in fine fragrance, deodorants and cosmetics, household products such as laundry detergents and air fresheners, Shampoos and Body Washes||(G) methyl phenylethyl cyclopropanemethanol.|
|P-21-0014||2||11/06/2020||CBI||(G) oil and gas extraction||(G) Aliphatic alcohol, bis-tetra-alkyl ammonium, chloride salts.|
|P-21-0015||1||10/30/2020||Designer Molecules, Inc||(S) As a raw material in a Temporary Bonding Adhesive formulation||(S) Amines, C36-alkylenedi-, polymers with 5,5′-[(1-methylethylidene)bis(4,1-phenyleneoxy)]bis[1,3-isobenzofurandione] and 4,4′-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]bis[2-aminophenol].|
|P-21-0016||1||11/02/2020||CBI||(G) Paint additive, Additive in coating formulations, Component in cleaning agents||(G) Alkanoic acid, dialkyl ester.|
|P-21-0017||1||11/12/2020||Sumitomo Chemical Advanced Technologies LLC||(S) Substance used to improve physical properties in rubber products||(G) [(Substituted-carbomonocyclic) amino] oxoalkenoic acid, inorganic salt.|
|P-21-0018||1||11/12/2020||Shin-Etsu Microsi||(G) Contained use for microlithography for electronic device manufacturing||(G) Sulfonium, triphenyl-, heterocyclic compound-carboxylate (1:1).|
|P-21-0019||2||11/17/2020||CBI||(G) The notified substance will be used as a fragrance ingredient||(G) Ethyl 4-alkyl-2-oxocycloalkanecarboxylate.|
|P-21-0022||1||11/20/2020||CBI||(S) Flexographic water-based Ink & coating vehicle||(G) Rosin acid esters.|
|P-21-0023||1||11/23/2020||CBI||(G) Photolithography||(G) Sulfonium, carbocyclic-, salt with 1-(alkyl) 2-[4-[polyhydro-2-carbomonocyclic-5-(polyfluoro-2-sulfoalkyl)-4,7-methano-1,3-benzodioxol-2-yl]carbomonocyclic oxy]acetate (1:1).|
|P-21-0027||1||11/23/2020||CBI||(G) An ingredient used in the manufacture of photoresist||(G) Heteropolycyclic, trihaloalkyl carbomonocycle-, hydroxy carbomonocyclic salt.|
|SN-17-0006A||5||10/29/2020||CBI||(G) Physical characteristics modifier for industrial use 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 Start Printed Page 8791to 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 11/01/2020 to 11/30/2020
|Case No.||Received date||Commencement date||If amendment, type of amendment||Chemical substance|
|P-09-0492||10/30/2020||10/29/2020||N||(G) Isocyanate polymer, amine blocked.|
|P-17-0387||11/03/2020||10/22/2020||N||(G) Dicarboxylic acids, polymers with alkanoic acid, alkanediol, substituted-alkylalkanoic acid, substituted alkyl carbomonocyle, alkanedioic acid and alkanediol, alkanolamine blocked, compds. with alkanolamine.|
|P-18-0355||11/19/2020||11/10/2020||N||(G) Alkanediol, substituted alkyl, polymer with carbomonocyle, alkanedioate substituted carbomonocycle, ester with substituted alkanoate.|
|P-19-0038||11/23/2020||11/20/2020||N||(S) Fatty acids, coco, iso-bu esters.|
|P-20-0098||11/20/2020||11/13/2020||N||(G) Calcium cycloaklylcarboxylate.|
|P-20-0160||11/23/2020||11/18/2020||N||(S) Amines,c36-alkylenedi-, polymers with bicyclo[2.2.1]heptanedimethanamine, [5,5′-biisobenzofuran]-1,1′,3,3′-tetrone and 3a,4,4a,7a,8,8a-hexahydro-4,8-ethano1h,3h-benzo[1,2-c:4,5-c′]difuran-1,3,5,7-tetrone, maleated.|
|* 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 11/01/2020 to 11/30/2020
|Case No.||Received date||Type of test information||Chemical substance|
|P-20-0066||11/24/2020||Daphnia Magna Reproduction Study (OECD Test Guideline 211)||(G) 2-propenoic acid, 2-hydroxyethyl ester, reaction products with dialkyl hydrogen heterosubstituted phosphate and dimethyl phosphonate.|
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.
End Supplemental Information
Dated: January 5, 2021.
Director, Information Management Division, Office of Pollution Prevention and Toxics.
[FR Doc. 2021-02660 Filed 2-8-21; 8:45 am]
BILLING CODE 6560-50-P