89 FR 167 pgs. 68899-68902 - Certain New Chemicals; Receipt and Status Information for July 2024
Type: NOTICEVolume: 89Number: 167Pages: 68899 - 68902
Pages: 68899, 68900, 68901, 68902Docket number: [EPA-HQ-OPPT-2024-0057; FRL-11683-07-OCSPP]
FR document: [FR Doc. 2024-19304 Filed 8-27-24; 8:45 am]
Agency: Environmental Protection Agency
Official PDF Version: PDF Version
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2024-0057; FRL-11683-07-OCSPP]
Certain New Chemicals; Receipt and Status Information for July 2024
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 under EPA review or have recently concluded review. This document covers the period from 7/01/2024 to 7/31/2024.
DATES:
Comments identified by the specific case number provided in this document must be received on or before September 27, 2024.
ADDRESSES:
Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2024-0057, through the Federal eRulemaking Portal at https://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 and visiting the docket, along with more information about dockets generally, is available at 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 7/01/2024 to 7/31/2024. 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: https://www.epa.gov/chemicals-under-tsca .
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?
[top] 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
2. Tips for preparing your comments. When preparing and submitting your comments, see the commenting tips at https://www.epa.gov/dockets/commenting-epa-dockets .
II. Status Reports
In the past, EPA has published individual notices reflecting the status of TSCA section 5 filings received, pending or concluded. In 1995, the Agency modified its approach and streamlined the information published in the Federal Register after providing notice of such changes to the public and an opportunity to comment (see the Federal Register of May 12, 1995 (60 FR 25798) (FRL-4942-7)). Since the passage of the Lautenberg amendments to TSCA in 2016, public interest in information on the status of section 5 cases under EPA review and, in particular, the final determination of such cases, has increased. In an effort to be responsive to the regulated community, the users of this information, and the general public, to comply with the requirements of TSCA, to conserve EPA resources and to streamline the process and make it more timely, EPA is providing information on its website about cases reviewed under the amended TSCA, including the section 5 PMN/SNUN/MCAN and exemption notices received, the date of receipt, the final EPA determination on the notice, and the effective date of EPA's determination for PMN/SNUN/MCAN notices on its website at: https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/status-pre-manufacture-notices . This information is updated on a weekly basis.
III. Receipt Reports
For the PMN/SNUN/MCANs that have passed an initial screening by EPA during this period, Table I provides the following information (to the extent that such information is not subject to a CBI claim) on the notices screened by EPA during this period: The EPA case number assigned to the notice that indicates whether the submission is an initial submission, or an amendment, a notation of which version was received, the date the notice was received by EPA, the submitting manufacturer ( i.e., domestic producer or importer), the potential uses identified by the manufacturer in the notice, and the chemical substance identity.
As used in each of the tables in this unit, (S) indicates that the information in the table is the specific information provided by the submitter, and (G) indicates that this information in the table is generic information because the specific information provided by the submitter was claimed as CBI. Submissions which are initial submissions will not have a letter following the case number. Submissions which are amendments to previous submissions will have a case number followed by the letter "A" ( e.g. P-18-1234A). The version column designates submissions in sequence as "1", "2", "3", etc. Note that in some cases, an initial submission is not numbered as version 1; this is because earlier version(s) were rejected as incomplete or invalid submissions. Note also that future versions of the following tables may adjust slightly as the Agency works to automate population of the data in the tables.
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| Case No. | Version | Received date | Manufacturer | Use | Chemical substance |
|---|---|---|---|---|---|
| P-20-0031 | 1 | 07/17/2024 | CBI | (G) Intermediate | (G) Perfluorinated substituted 1,3-oxathiolane dioxide. |
| P-20-0033 | 1 | 07/17/2024 | CBI | (G) Intermediate | (G) Perfluorinated vinyl haloalkane sulfonate salt. |
| P-20-0034 | 1 | 07/17/2024 | CBI | (G) Intermediate | (G) Perfluorinated vinyl haloalkane sulfonyl halide. |
| P-23-0014 | 1 | 07/22/2024 | CBI | (G) [Polyalkyl-methylenepolyhydro-polycyclic]alkyl acetate. | |
| P-23-0177A | 3 | 07/19/2024 | Colonial Chemical, Inc | (G) Corrosion inhibitor | (G) fatty acids, vegetable oil, reaction products with diethylenetriamine. |
| P-24-0027A | 6 | 07/08/2024 | Mikros Biochem | (S) Surfactant for cleaners | (S) Fatty acids, C8-14, 2,3-diesters with rel-(2R, 3S)-2,3,4-trihydroxybutyl Beta-D-mannopyranoside acetate. |
| P-24-0079A | 4 | 07/12/2024 | CBI | (G) Fuel Additive | (G) Alkyated succinimide. |
| P-24-0079A | 5 | 07/19/2024 | CBI | (G) Fuel Additive | (G) Alkyated succinimide. |
| P-24-0104A | 5 | 07/17/2024 | CBI | (G) Plastic Additive | (G) carbomonocycle alkylamide, 3,5-bis(1,1-dialkyl) -4-hydroxy-N-[2,5-dioxo-3-(polyalkylene)-1- heteromonocyclic]-. |
| P-24-0109A | 3 | 07/09/2024 | CBI | (G) Electrolyte salt | (G) Lithium dihalo (oxalato)borate(1-). |
| P-24-0109A | 4 | 07/10/2024 | CBI | (G) Electrolyte salt | (G) Lithium dihalo (oxalato)borate(1-). |
| P-24-0130A | 3 | 07/12/2024 | CBI | (S) Sulfur Scavenger | (G) poly(alkoxy)alkanol. |
| P-24-0161A | 3 | 06/27/2024 | Cargill, Incorporated | (S) Feedstock for production of biofuel | (S) Fats and glyceridic oils, camelina sativa. Extractives and their physically modified derivatives. It consists primarily of the glycerides of the fatty acids docosenoic, eicosenoic, linoleic, linolenic, oleic, palmitic and stearic. (Camelina sativa). |
| P-24-0161A | 4 | 07/08/2024 | Cargill, Incorporated | (S) Feedstock for production of biofuel | (S) Fats and glyceridic oils, camelina sativa. Extractives and their physically modified derivatives. It consists primarily of the glycerides of the fatty acids docosenoic, eicosenoic, linoleic, linolenic, oleic, palmitic and stearic. (Camelina sativa). |
| P-24-0162A | 3 | 07/25/2024 | Proton Power, Inc | (S) Increases strength of epoxy, plastics, moulding compounds, strength, modulus, tear resistance for polyurethane foam; Improves the rutting behavior of asphalt; Improves the capacity and thermal and electrical conductivity for batteries, strength of body armor and helmets, drying time and antifouling for paints | (S) single and multilayer turbostratic graphene. |
| P-24-0164A | 2 | 07/09/2024 | Huntsman International, LLC | (S) Intermediate in the production of a catalyst | (S) 2-Propanamine, N,N'-(oxydi-2,1-ethanediyl)bis-. |
| P-24-0171A | 2 | 07/17/2024 | CBI | (G) Making of air pollutants control parts in automobiles | (G) Metal and rare earth metal zirconium oxide. |
| P-24-0172A | 2 | 07/17/2024 | CBI | (G) Manufacturing of air pollutants control parts | (G) Metal and rare earth metal zirconium oxide. |
| P-24-0173 | 1 | 07/12/2024 | CBI | (G) For making air pollutant control parts in automobiles | (G) Rare earth doped zirconium oxide |
| P-24-0174 | 1 | 07/12/2024 | CBI | (G) Making air pollutants control parts in automobiles | (G) Rare earth doped zirconium oxide. |
| P-24-0175 | 1 | 07/12/2024 | CBI | (G) Air pollutants control parts in automobiles | (G) Rare earth doped zirconium oxide. |
| P-24-0176 | 1 | 07/12/2024 | CBI | (G) Making of air pollutants control parts in automobiles | (G) Rare earth doped zirconium oxide. |
| P-24-0177 | 1 | 07/12/2024 | CBI | (G) Air pollutants control parts in automobiles | (G) Rare earth doped zirconium oxide. |
| P-24-0178 | 1 | 07/15/2024 | Advancion | (G) Paints and coatings, home and personal care, metal working fluids, electronics | (S) 2-Butanol, 3-amino-3-methyl. |
| P-24-0183 | 1 | 07/25/2024 | HPC Holdings, Inc | (G) Chemical intermediate | (S) 1-Butanone, 4,4,4-trifluoro-3-hydroxyl-1-(2-naphthalenyl)-3-(trifluoromethyl)-. |
| SN-24-0007A | 2 | 07/22/2024 | CBI | (G) Additive for plastic, Intermediate | (G) Inorganic acid, metal salt, compd. with substituted aromatic heterocycle. |
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.
| Case No. | Received date | Commencement date | If amendment, type of amendment | Chemical substance |
|---|---|---|---|---|
| P-18-0172 | 07/17/2024 | 08/28/2019 | N | (S) Calcium, carbonate 2-ethylhexanoate neodecanoate propionate complexes. |
| P-22-0005A | 07/22/2024 | 07/12/2024 | N | (S) Formic acid, compd. with 2-methyl-1,5-pentanediamine (2:1). |
| P-22-0083 | 07/16/2024 | 07/04/2024 | N | (S) Oils, sandalwood, santalene synthase-modified Rhodobacter sphaeroides-fermented, from D-Glucose, oxidized. |
| P-22-0192 | 06/27/2024 | 06/20/2024 | N | (G) Sulfonium, tricarbocyclic-, polyfluoro-heteroatom-substituted polycarbocyclicalkanesulfonate (1:1). |
| P-23-0124 | 06/27/2024 | 06/20/2024 | N | (G) Sulfonium, tricabocyclic-, 2-heteroatom-substituted-(halocarbocyclic)carboxylate (1:1). |
| P-23-0126 | 07/15/2024 | 07/08/2024 | N | (G) Alken-1-ol. |
| P-23-0135 | 07/15/2024 | 07/08/2024 | N | (G) Alken-1-ol, 1-acetate. |
| P-23-0172 | 06/27/2024 | 06/20/2024 | N | (G) Sulfonium, tricarbocyclic-, alkylcarbomocyclic-polyfluoro-heteropolycyclic-alkyl sulfonate (1:1), polymer with alkylaryl and carbomonocyclic alkylalkanoate, di-Me 2,2'-(1,2-diazenediyl)bis(2-alkylalkanoate)-initiated. |
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.
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| Case No. | Received date | Type of test information | Chemical substance |
|---|---|---|---|
| L-23-0173 | 07/09/2024 | Algal Toxicity (OECD Test Guideline 201) | (G) Cis-alkenoic acid. |
| P-14-0712 | 07/10/2024 | Polychlorinated Dibenzodioxins and Polychlorinated dibenzofurans Testing | (S) Waste plastics, pyrolyzed, C5-55 fraction. |
| P-18-0124 | 07/08/2024 | 90-Day Inhalation Toxicity (OECD Test Guideline 413) | (S) Lithium nickel potassium oxide. |
| P-21-0202, P-23-0104 | 07/23/2024 | Determination of Dissociation Constant (Conductometric Method; OECD Guideline 112 OPPTS 830.7370) | (G) Sulfonium, carbomonocycle bis[(trihaloalkyl)carbomonocycle], substituted carbomonocyclic ester; (G) Sulfonium, carbomonocycle bis[(trihaloalkyl)carbomonocycle], disubstituted carbomonocyclic ester. |
| P-24-0154 | 07/12/2024 | Melting Point/Melting Range (OECD Test Guideline 102); Boiling Point/Boiling Range (OECD Test Guideline 103); Storage Stability (OECD Test Guideline 113); Combined Repeated Dose Toxicity with the Reproduction/Development Toxicity Screening Test (OECD Test Guideline 422); Particle Size, Fiber Length, Diameter Distribution (OECD Test Guideline 110); Density/Relative Density/Bulk Density (OECD Test Guideline 109); In Vitro Skin Irritation Testing; Primary Skin Irritation Testing in Rabbits | (G) Polyphenyl, ethoxy-polyfluoro-alkyl-. |
| P-24-0154 | 07/12/2024 | Acute Oral Toxicity (OECD Test Guideline 423); Acute Eye Irritation (OECD Test Guideline 405); Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage (OECD Test Guideline 437); In Vitro Mammalian Chromosome Aberration Test (OECD Test Guideline 473); Skin Sensitization (OECD Test Guideline 429); Flammability Testing; Bacterial Reverse Mutation Test (OECD Test Guideline 471) | (G) Polyphenyl, ethoxy-polyfluoro-alkyl-. |
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: August 22, 2024.
Pamela Myrick,
Director, Project Management and Operations Division, Office of Pollution Prevention and Toxics.
[FR Doc. 2024-19304 Filed 8-27-24; 8:45 am]
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