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, 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 03/01/2021 to 03/31/2021.
DATES:
Comments identified by the specific case number provided in this document must be received on or before May 27, 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, through 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 emergency, 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: (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 03/01/2021 to 03/31/2021. 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 Toxic Substances Control Act (TSCA), including the TSCA 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 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 03/01/2021 to 03/31/2021
Case No. | Version | Received date | Manufacturer | Use | Chemical substance |
---|---|---|---|---|---|
J-21-0004 | 3 | 01/25/2021 | Danisco US, Inc | (G) Production of a chemical substance | (G) Genetically modified microorganism for the production of a chemical substance. |
J-21-0005A | 4 | 03/05/2021 | CBI | (G) Chemical production | (G) Modified Saccharomyces cerevisiae enhanced ethanol yield. |
J-21-0006A | 4 | 03/05/2021 | CBI | (G) Chemical production | (G) Modified Saccharomyces cerevisiae enhanced ethanol yield. |
P-16-0404A | 6 | 03/01/2021 | CBI | (G) A colorant for dyeing various synthetic fibers and fabrics. Open, non-dispersive use | (G) Alkyl ester, 2-({4-[2-(trisubstituted phenyl)azo]-5-acetamido-2-substitutedphenyl} (substituted alkoxy)amino). |
P-18-0281A | 5 | 03/26/2021 | CBI | (G) Electrolyte additive | (G) Cyclic sulfate. |
P-18-0301A | 4 | 03/31/2021 | 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-18-0326A | 10 | 03/29/2021 | CBI | (G) Chemical Intermediate | (G) Alkanoic acid, alkyl ester, manuf. of, byproducts from, distn. residues. |
P-18-0378A | 6 | 03/18/2021 | CBI | (G) Industrial coatings additive | (G) Acrylic and Methacrylic acids and esters, polymer with alkenylimidazole, alkyl polyalkylene glycol, alkenylbenzene, alkylbenzeneperoxoic acid ester initiated, compds. with Dialkylaminoalkanol. |
P-20-0058A | 6 | 03/18/2021 | 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-20-0058A | 7 | 03/19/2021 | 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-20-0078A | 7 | 03/24/2021 | Ascend Performance Materials | (G) Stabilizer for industrial applications | (G) Dicarboxylic acid, compd. with aminoalkyl-alkyldiamine alkyldioate alkyldioate (1:2:1:1). |
P-20-0079A | 7 | 03/24/2021 | Ascend Performance Materials | (G) Stabilizer for industrial applications | (G) Dicarboxylic acid, compd. with aminoalkyl-alkyldiamine (3:2). |
P-20-0080A | 10 | 03/24/2021 | Ascend Performance Materials | (G) Stabilizer for industrial applications | (G) Alkyldiamine, aminoalkyl-, hydrochloride (1:3). |
P-20-0081A | 10 | 03/24/2021 | Ascend Performance Materials | (G) A stabilizer for industrial applications | (G) Carboxylic acid, compd. with aminoalkyl-alkyldiamine (3:1). |
P-20-0082A | 10 | 03/24/2021 | Ascend Performance Materials | (G) Stabilizer for industrial applications | (G) Alkyldiamine, aminoalkyl-, carboxylate (1:3). |
P-20-0144A | 5 | 03/01/2021 | CBI | (G) Asphalt emulsion applications | (S) Fatty acids, soya, reaction products with polyethylenepolyamines. |
P-20-0148A | 6 | 03/15/2021 | Solugen Inc | (G) Additive for consumer, industrial, and commercial uses | (G) Hydroxyalkanoic acid, salt, oxidized. |
P-20-0148A | 7 | 03/22/2021 | Solugen Inc | (G) Additive for consumer, industrial, and commercial uses | (G) Hydroxyalkanoic acid, salt, oxidized. |
P-20-0149A | 6 | 03/15/2021 | Solugen Inc | (G) Additive for consumer, industrial, and commercial uses | (G) Hydroxyalkanoic acid, salt, oxidized. |
P-20-0149A | 7 | 03/22/2021 | Solugen Inc | (G) Additive for consumer, industrial, and commercial uses | (G) Hydroxyalkanoic acid, salt, oxidized. |
P-20-0150A | 6 | 03/15/2021 | Solugen Inc | (G) Additive for consumer, industrial, and commercial uses | (G) Hydroxyalkanoic acid, salt, oxidized. |
P-20-0150A | 7 | 03/22/2021 | Solugen Inc | (G) Additive for consumer, industrial, and commercial uses | (G) Hydroxyalkanoic acid, salt, oxidized. |
P-20-0151A | 6 | 03/15/2021 | Solugen Inc | (G) Additive for consumer, industrial, and commercial uses | (G) Hydroxyalkanoic acid, salt, oxidized. |
P-20-0151A | 7 | 03/22/2021 | Solugen Inc | (G) Additive for consumer, industrial, and commercial uses | (G) Hydroxyalkanoic acid, salt, oxidized. |
P-20-0169A | 6 | 03/15/2021 | CBI | (G) Battery Plastics and coatings applications, Conductive agent for conductive plastic and paint | (S) multiwalled carbon nanotube. |
P-20-0169A | 7 | 03/26/2021 | CBI | (G) Battery Plastics and coatings applications, Conductive agent for conductive plastic and paint | (S) multiwalled carbon nanotube. |
P-20-0174A | 5 | 03/16/2021 | 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 | 3 | 03/16/2021 | 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-21-0012A | 4 | 03/24/2021 | CBI | (G) The notified substance will be used as a fragrance ingredient | (G) Multialkylbicycloalkenyl substituted propanenitrile. |
P-21-0028 | 2 | 03/01/2021 | CBI | (G) Hardener for composite applications | (G) Phenol, methylethylidene, polymer chloromethyl epoxide and methylethylidene bis-oxy, bis-amine. |
P-21-0029 | 2 | 03/01/2021 | CBI | (G) Bulk formulated mixture for research and development purposes only | (G) Amine, methylethylidenebis(oxy). |
P-21-0066A | 5 | 03/02/2021 | L & L Products | (S) Blended or stand alone, epoxy curative (hardener) and foaming agent when blended with certain ingredients | (G) 1,2-alkanediol, 3 aryloxy, mono phosphate ester. |
P-21-0086 | 3 | 03/18/2021 | Croda Inc | (G) Marine engine oil additive, polymer additive, Greases, Refrigeration oil, Metal working fluid, Industrial drilling oil, Industrial Rolling oil, Compressor Oil, hydraulic oil, Inudstrial turbine oil, Industrial gear oil, Automotive engine oil additive, Automotive gear oil | (S) Isooctadecanamide, N,N-bis(2-ethylhexyl). |
P-21-0086A | 4 | 03/26/2021 | CRODA INC | (G) Automotive engine oil additive, polymer additive Greases, Refrigeration oil, Metal working fluid, Industrial drilling oil, Industrial Rolling oil, Compressor Oil, hydraulic oil, Inudstrial turbine oil, Industrial gear oil, Automotive gear oil, Marine engine oil additive | (S) Isooctadecanamide, N,N-bis(2-ethylhexyl). |
P-21-0090 | 3 | 03/02/2021 | CBI | (G) Component in paving formulations | (G) Lignin, modified, reaction products with alkylamine by-products. |
P-21-0091 | 3 | 03/12/2021 | CBI | (G) Laundry detergent additive/emulsifier., emulsifier—water treatment, Emulsifier, Industrial fluid, Coatings and Plastics | (G) Fatty acid esters polymer with Dicarboxylic Acid. |
P-21-0092 | 3 | 03/09/2021 | Miwon North America, Inc. | (S) thermoset composites, industrial coatings, 3D printing | (G) 2-Propenoic acid, (polyhydro-1,3-dioxo-2H-isoindol-2-yl)alkyl ester. |
P-21-0094 | 1 | 03/01/2021 | CBI | (S) Deposition precursor for the manufacture of electronic components | (G) Silane, halogenated. |
P-21-0095 | 4 | 03/16/2021 | CBI | (S) Crankcase Motor Oil applications, formulated transmission oils. Industrial applications (especially compressor and gear fluids) | (G) Alkene Homopolymer Hydrogenated. |
P-21-0095A | 5 | 03/30/2021 | CBI | (S) Crankcase Motor Oil applications, formulated transmission oils. Industrial applications (especially compressor and gear fluids) | (G) Alkene Homopolymer Hydrogenated. |
P-21-0097 | 1 | 03/05/2021 | CBI | (S) Plasticizer for use in dryblend applications (i.e.—injection molding, slush molding, extrusion, calendering), Component in lubricants and industrial oils, Plastisol in spread-coating applications. | (S) 1,2,4-Benzenetricarboxylic acid, trinonyl ester, branched and linear. |
P-21-0098 | 3 | 03/18/2021 | 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-21-0100 | 1 | 03/24/2021 | ENI Trading & Shipping Inc | (G) Used as a lubricant and lubricant additive, Lubricant and lubricant additive | (G) Raffinates (petroleum), vacuum distillate solvent, solvent-dewaxed, hydrotreated. |
P-21-0101 | 1 | 03/24/2021 | ENI Trading & Shipping Inc | (G) Used as a lubricant and lubricant additive, Lubricant and lubricant additive | (G) Benzenesulfonic acid, polyalkyl derivs., calcium salts. |
SN-20-0007A | 2 | 03/08/2021 | CBI | (S) A component of UV Curable Coatings and Printing Inks | (S) 2-Propenoic acid, 1,1′-(3-methyl-1,5-pentanediyl) ester. |
SN-21-0003 | 1 | 03/02/2021 | Norquay Technology Inc | (G) Intermediate | (S) 1,1′-Biphenyl, 4,4′-dibromo-. |
* 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 03/01/2021 to 03/31/2021
Case No. | Received date | Commencement date | If amendment, type of amendment | Chemical substance |
---|---|---|---|---|
P-01-0925 | 03/30/2021 | 04/16/2004 | N | (G) 1,2 ethanediamine, n-[3-trimethoxysilyl) propyl] reaction product with silanes. |
P-01-0926 | 03/30/2021 | 04/16/2004 | N | (G) 2-propenoic acid, 2-methyl-butyl ester polymer. |
P-17-0390 | 03/09/2021 | 02/27/2021 | N | (G) Carbomonocyclic dicarboxylic acid, polymer with alkenedioic acid, substituted heteropolycycle, substituted heteromonocycle, alkanediol, alkanedioic acid, alkoxylated substituted dicarbomonocycle, alkoxylated substituted dicarbomonocycle and alkanetriol, carbomonocyclic carboxylate alkanoate. |
P-18-0308 | 03/15/2021 | 02/23/2021 | N | (G) Bis[(hydroxyalkoxy)aryl]carbopolycyclic. |
P-20-0094 | 03/23/2021 | 03/17/2021 | N | (G) Aliphatic urethane methacrylate. |
P-20-0097 | 03/29/2021 | 03/24/2021 | N | (G) Butanedioic acid, monopolyisobutylene derivs., mixed dihydroxyalkyl and hydroxyalkoxyalkyl diesters. |
P-20-0185 | 03/12/2021 | 03/09/2021 | N | (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-benzofurandione, maleated. |
P-87-0115 | 03/05/2021 | 02/26/2021 | N | (G) Polyurethane prepolymer. |
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 03/01/2021 to 03/31/2021
Case No. | Received date | Type of test information | Chemical substance |
---|---|---|---|
L-21-0067 | 03/11/2021 | Fish Acute Toxicity Test and Earthworm Acute Toxicity Test | (G) Graphene nanoplatelet. |
L-21-0067 | 03/11/2021 | Fish Acute Toxicity Test and Earthworm Acute Toxicity Test | (G) Graphene nanoplatelets. |
P-16-0404A | 03/01/2021 | Fish Acute Toxicity Test, Freshwater, and Marine (OCSPP Test Guideline 850.1075) | (G) Alkyl ester, 2-({4-[2-(trisubstituted phenyl)azo]-5-acetamido-2-substitutedphenyl} (substituted alkoxy)amino). |
P-18-0294 | 03/10/2021 | Chemilian H4000 XP: ToxTracker ACE Assay | (S) Propanedioic acid, 2-methylene-, 1,3-dicyclohexyl ester. |
P-18-0350 | 03/08/2021 | Surface Tension of Aqueous Solutions (Test Guideline OECD 115) | (G) Aqueous methacrylamido modified polysiloxane. |
P-18-0374 | 03/08/2021 | Surface Tension of Aqueous Solutions (Test Guideline OECD 115) | (G) Cationic aminomodified alkylpolysiloxane. |
* 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. |
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: April 19, 2021.
Pamela Myrick,
Director, Project Management and Operations Division, Office of Pollution Prevention and Toxics.
[FR Doc. 2021-08756 Filed 4-26-21; 8:45 am]
BILLING CODE 6560-50-P