Skip to Content

We invite you to try out our new beta eCFR site at https://ecfr.federalregister.gov. We’ve made big changes to make the eCFR easier to use. Be sure to leave feedback using the 'Feedback' button on the bottom right of each page!

Notice

Certain New Chemicals; Receipt and Status Information for June 2021

This document has a comment period that ends in 21 days. (08/20/2021) Submit a formal comment

Thank you for taking the time to create a comment. Your input is important.

Once you have filled in the required fields below you can preview and/or submit your comment to the Environmental Protection Agency for review. All comments are considered public and will be posted online once the Environmental Protection Agency has reviewed them.

You can view alternative ways to comment or you may also comment via Regulations.gov at, https://www.regulations.gov/commenton/EPA-HQ-OPPT-2021-0068-0006.

  1. Note: You can attach your comment as a file and/or attach supporting documents to your comment. Attachment Requirements.


  2. this will NOT be posted on regulations.gov


  3. An Individual

    An Organization

    Anonymous




  1. Preview Comment
Please review the Regulations.gov privacy notice and user notice .
Document Details

Information about this document as published in the Federal Register.

Document Statistics
Document page views are updated periodically throughout the day and are cumulative counts for this document. Counts are subject to sampling, reprocessing and revision (up or down) throughout the day.
Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

Start Preamble

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 Start Printed Page 38476document covers the period from 06/01/2021 to 06/30/2021.

DATES:

Comments identified by the specific case number provided in this document must be received on or before August 20, 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, 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.

Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/​dockets.

Start Further Info

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.

End Further Info End Preamble Start Supplemental Information

SUPPLEMENTARY INFORMATION:

I. Executive Summary

A. What action is the Agency taking?

This document provides the receipt and status reports for the period from 06/01/2021 to 06/30/2021. 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 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 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 Start Printed Page 38477cases 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 06/01/2021 to 06/30/2021

Case No.VersionReceived dateManufacturerUseChemical substance
J-21-0010202/11/2021Danisco US, Inc(G) Production of a chemical substance(G) Genetically modified microorganism for the production of a chemical substance.
J-21-0011205/11/2021Lesaffre Yeast Corporation(G) Ethanol production(G) Saccharomyces cerevisiae fermenting C5 sugars, modified.
J-21-0011A306/22/2021Lesaffre Yeast Corporation(G) Ethanol production(G) Saccharomyces cerevisiae fermenting C5 sugars, modified.
P-18-0293A1306/23/2021Sirrus, Inc(S) Intermediate: Monomer used as a chemical intermediate in the manufacture of polymers(S) Propanedioic acid, 2-methylene-, 1,3-dihexyl ester.
(G) Coatings: Monomer used in the manufacture of industrial coatings (e.g., protective floor coatings)
(G) Adhesives: Monomer used in the manufacture (formulation) of adhesives (e.g., reactive, industrial structural adhesives or lamination). Adhesives are applied from a liquid form as a bead or film and are applied via static mixer, roller, brush, roll coater, or squeegee
P-18-0294A1306/23/2021Sirrus, Inc(S) Intermediate: Monomer used as a chemical intermediate in the manufacture of polymers(S) Propanedioic acid, 2-methylene-, 1,3-dicyclohexyl ester.
(G) Coatings: Monomer used in the manufacture of industrial coatings (e.g., protective floor coatings)
(G) Adhesives: Monomer used in the manufacture (formulation) of adhesives or lamination. Adhesives are applied from a liquid as a bead or film and are applied via static mixer, roller, brush, roll coater, or squeegee
P-20-0005A605/28/2021RMC Advanced Technologies Inc(G) Additive for plastics and resins(G) modified graphene.
P-20-0010A1306/09/2021CBI(G) Polymerization auxiliary(G) Carboxylic acid, reaction products with metal hydroxide, inorganic dioxide and metal.
P-20-0077A706/01/2021CBI(S) UV Curing Agent for use in Inks and Coatings(G) 1-(dialkyl-diphenylene alkane)-2-alkyl-2-hydrooxazine-1-alkylketone;.
P-21-0005A506/02/2021Evonik Corporation(S) Polymeric additive in gear oils(G) Carbonmonocyclic alkene polymer with alkyl alkenoate, alkyl alkenoate, alkyl alkenoate and polyalkyldiene alkenoate.
P-21-0020A406/03/2021Allnex USA Inc(S) Modifier for hardness development in paint formulations for metal applications(G) Alkanedioic acid, dialkyl ester, polymer with dialkyl-alkanediol, alkyl(substituted alkyl)-alkanediol and heteropolycycle.
P-21-0077A206/02/2021CBI(G) battery additive(G) Alkylene Sulfate.
P-21-0077A306/08/2021CBI(G) battery additive(G) Alkylene Sulfate.
P-21-0085A306/21/2021CBI(G) Used as an additive in the manufacture of tires to improve performance(S) 1-Propanethiol, 3-(triethoxysilyl)-, reaction products with polybutadiene.
Start Printed Page 38478
P-21-0133206/29/2021CBI(S) Chemical Intermediate(G) Distillation bottoms from manufacture of alkanoic acid by organic acid-producing organism, modified.
P-21-0138206/22/2021LG Energy Solution Michigan Inc(S) Electrode material for use in the manufacture of batteries(G) Lithium metal oxide.
P-21-0139105/28/2021Solvay Chemicals Inc(S) Stationary Energy Storage(S) Methanesulfonamide,1,1,1-trifluoro-N-[(trifluoromethyl)sulfonyl]-, sodium salt (1:1).
P-21-0140105/28/2021CHS Inc(G) Raw material for Viscosity Modifier(S) Soybean oil, oleic acid-high, epoxidized.
P-21-0141206/08/2021Valero Energy Corporation(S) Transportation Fuel(S) Alkanes, C4-8—Branched and Linear.
P-21-0141A306/14/2021Valero Energy Corporation(S) Transportation Fuel(S) Alkanes, C4-8—Branched and Linear.
P-21-0141A406/23/2021Valero Energy Corporation(S) Transportation Fuel(S) Alkanes, C4-8—Branched and Linear.
P-21-0142206/04/2021CBI(S) Resin/binder in paint formulations for industrial applications(G) Organic acid dimethyl ester, polymer with mixed alkanediolsand 5-isocyanato-1-(isocyanatomethyl)-1,3,3-trimethylcyclohexane, N-(trimethoxysilylalkyl)alkanamine blocked.
P-21-0143106/07/2021CBI(G) Coating ingredient, Adhesive ingredient(G) Aliphatic Diisocyanate, homopolymer, aliphatic alcohol blocked.
P-21-0143A206/18/2021CBI(G) Coating ingredient, Adhesive ingredient(G) Aliphatic Diisocyanate, homopolymer, aliphatic alcohol blocked.
P-21-0144106/07/2021Chevron(G) Gasoline(G) Naphtha, heavy catalytic cracked.
P-21-0145106/07/2021Chevron(G) Gasoline(G) Naphtha, heavy alkylate.
P-21-0146106/07/2021Chevron(G) gasoline(G) Naphtha, full range alkylate, butane-contg.
P-21-0147106/07/2021Chevron(G) Gasoline(G) Naphtha, hydrotreated heavy.
P-21-0148106/07/2021Chevron(G) Gasoline(G) Naphtha, light catalytic cracked.
P-21-0149106/07/2021Chevron(G) Aviation gasoline(G) Naphtha, light alkylate.
P-21-0150106/07/2021Chevron(G) Gasoline(G) Naphtha, hydrotreated light.
P-21-0151106/08/2021CBI(G) Polyurethane applications(G) Epoxidized Vegetable oil, polymer with bisphenol A, aryl glycidyl ether, epichlorohydrin, polyethylene glycol and trimethylolpropane.
P-21-0152306/14/2021Chevron(G) Marine fuel(G) Clarified oils, catalytic cracked.
P-21-0153306/14/2021Chevron(G) Chemical intermediate(G) Distillates, hydroteated heavy.
P-21-0154306/14/2021Chevron(G) chemical intermediate(G) Gas Oils hydrotreated vacuum.
P-21-0155106/08/2021Chevron(G) Diesel fuel(G) Distillates, light catalytic cracked.
P-21-0156106/08/2021Chevron(G) Jet fuel(G) Distillates, clay-treated middle.
P-21-0157106/08/2021Chevron(G) diesel fuel(G) Distillates, hydrotreated middle.
P-21-0158106/08/2021Chevron(G) jet fuel(G) Distillates, hydrotreated light.
P-21-0159306/14/2021Chevron(G) chemical intermediate(G) Gases, C3-C4.
P-21-0160306/14/2021Chevron(G) chemical intermediate(G) Gases, C4-rich.
P-21-0161306/14/2021Chevron(G) chemical intermediate(G) Gases, catalytic cracking.
P-21-0162306/14/2021Chevron(G) chemical intermediate(G) Residues, butane splitter bottoms.
P-21-0163306/14/2021Chevron(G) chemical intermediate(G) Tail gas, saturate gas plant mixed stream, C4-rich.
P-21-0164106/09/2021Polysi Research LLC(S) Crosslinker for waterproofing(S) 2-Butanone, oxime, reaction products with Trimethoxymethylsilane.
P-21-0165106/09/2021Colonial Chemical, Inc(S) anionic surfactant in cleaning products(S) DGlucopyranose, oligomeric, C1016alkyl glycosides, 3(3,4dicarboxy3hydroxy1oxobutoxy)2hydroxypropyl ethers, sodium salts.
P-21-0166106/11/2021Rudolf Venture Chemical(S) Textile softening agent(G) Siloxanes and Silicones, di-Me, [alkylpiperazinium-hydroxyalkoxy]alkyl group-terminated, arylsulfonates (salts).
P-21-0167106/11/2021Rudolf Venture Chemical(S) Textile softening agent(G) Siloxanes and Silicones, di-Me, [alkylpiperazinium-hydroxyalkoxy]alkyl group- and (hydroxyalkoxy)alkyl group-terminated, ethers with polyethylene glycol alkyl ethers, arylsulfonates (salts).
P-21-0174106/22/2021Marubeni America Corporation(G) Raw material for polyurethane(G) Carbonic acid, ester, polymer with alkanediol (C=4,5).
P-21-0175106/22/2021Marubeni America Corporation(G) Raw material of polyurethane(G) Carbonic acid, ester, polymer with alkanediol (C=4,10).
P-21-0176206/29/2021CBI(G) component in plastics(G) Alkane dioic acid, bis (poly aromatic triazine) alkanoic ether phenoxy ester.
SN-21-0010106/18/2021CBI(G) Additive used in coatings(G) 2-Oxepanone, reaction products with alkylenediamine-alkyleneimine polymer, 2-[[(2-alkyl)oxy]alkyl]oxirane and tetrahydro-2H-pyran-2-one.
* 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.Start Printed Page 38479

Table II—NOCs Approved * From 06/01/2021 to 06/30/2021

Case No.Received dateCommencement dateIf amendment, type of amendmentChemical substance
J-20-002506/04/202104/08/2021N(G) Biofuel producing saccharomyces cerevisiae modified, genetically stable.
J-21-0003A05/28/202104/16/2021Provided CBI substantiation(G) Genetically modified saccharomyces cerevisiae.
J-21-001005/25/202105/10/2021N(G) Genetically modified microorganism.
P-09-050606/03/202108/09/2010N(S) Hexanedioic acid, polymer with oxybis[propanol] and 1,2,3-propanetriol.
P-12-051806/22/202106/22/2021N(S) 1,2,3-propanetricarboxylic acid, 2-hydroxy-, titanium (4+) salt (5:2).
P-17-025906/17/202106/09/2021N(S) Benzenediamine, ar-chloro-ar,ar-diethyl-ar-methyl-.
P-19-011406/16/202105/23/2021N(G) Sulfonium, triphenyl-, trifluoro-hydroxy-(triheterosubstitutedalkyl)alkanoate (1:1),.
P-20-006805/27/202105/11/2021N(S) 1,3-propanediol, 2,2-dimethyl-, 1,3-diacetate.
P-20-006906/09/202105/10/2021N(S) 2-propenoic acid, 2-methyl-, polymer with 2-hydroxyethyl 2-methyl-2-propenoate phosphate and 2-propenoic acid, sodium salt, peroxydisulfuric acid ([(ho)s(o)2]2o2) sodium salt (1:2)- and sodium (disulfite) (2:1)-initiated.
P-20-010306/22/202102/01/2021N(G) Cycloalphatic amine formate.
P-20-014006/23/202106/19/2021N(G) N-substituted-beta-alanine, heterosubstituted-alkyl ester, ion(1-), triphenylsulfonium (1:1),.
P-20-014106/23/202106/19/2021N(G) Sulfonium, [4-(1,1-dimethylethyl)phenyl]diphenyl-, salt with heterosubstituted-alkyl tricycloalkane-carboxylate (1:1),.
P-20-016106/11/202105/14/2021N(S) Propanedioic acid, 2-methylene-, 1,3-diethyl ester, polymer with 1,4-butanediol.
P-20-016705/27/202105/03/2021N(G) Phenylene, alkyl and polycarbomonocycle substituted, 1,2-dicarboxylate.
P-94-049206/11/202105/27/2021N(S) 1,2,4-benzenetricarboxylic acid, trinonyl ester, branched and linear.
P-94-164706/10/202106/06/2021N(S) Isocyanic acid, polymethylenepolyphenylene ester, polymer with 2,2'-iminobis[ethanol] and 4-methyl-1,3-dioxolan-2-one, 2-hydroxyethyl methacrylate-blocked.
* 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 06/01/2021 to 06/30/2021

Case No.Received dateType of test informationChemical substance
P-18-040706/11/2021Acute Fish Toxicity (OECD Test Guidelines 203), Acute Fish Toxicity Phase Report Analysis, Hydrolysis as a Fucntion of pH (OECD Test Guidelines 111), Estimation of the Adsorption Coefficient (Koc) on Soil and on Sewage Sludge using High Performance Liquid Chromatography (HPLC) (OECD Test Guideline 121), and Modified Activated Sludge, Respiration Inhibition Test for sparingly Soluble Chemicals (OECD Test Guideline 209)(S) 1,2-ethanediamine, n,n-dimethyl-n-(1-methylethyl)-n-[2-[methyl(1-methylethyl)amino]ethyl]-.
P-20-001806/22/2021Freshwater Alga and Cyanobacteria, Growth Inhibition Test (OECD Test Guideline 201), and Fish, Early-Life Stage Toxicity Test (OECD Test Guideline 210)(G) Fatty acid dimers, polymers with glycerol and triglycerides.
P-12-024106/23/2021Annual Reporting of Certificate of Analysis(G) C6-2 Methacrylate.

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.

Start Signature

Dated: July 15, 2021.

Pamela Myrick,

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

End Signature End Supplemental Information

[FR Doc. 2021-15523 Filed 7-20-21; 8:45 am]

BILLING CODE 6560-50-P