89 FR 229 pgs. 93576-93580 - Certain New Chemicals; Receipt and Status Information for October 2024
Type: NOTICEVolume: 89Number: 229Pages: 93576 - 93580
Pages: 93576, 93577, 93578, 93579, 93580Docket number: [EPA-HQ-OPPT-2024-0057; FRL-11683-10-OCSPP]
FR document: [FR Doc. 2024-27717 Filed 11-26-24; 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-11683-10-OCSPP]
Certain New Chemicals; Receipt and Status Information for October 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 October 1, 2024 to October 31, 2024.
DATES:
Comments identified by the specific case number provided in this document must be received on or before December 27, 2024.
ADDRESSES:
[top] 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)
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 October 1, 2024 to October 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?
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 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
[top] 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
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-18-0127A | 2 | 10/01/2024 | Takasago | (S) Fragrance in fine fragrance, consumer products, household products (laundry detergent), shower gels and shampoos | (S) Heptane, 2-methoxy-2-methyl-. |
| P-21-0007A | 2 | 10/25/2024 | CBI | (G) Catalyst | (G) Reaction products of Aluminoxanes, Me, Me group-terminated and (alkylcycloalkenyl) dialkylzirconium. |
| P-21-0008A | 2 | 10/25/2024 | CBI | (G) Catalyst | (G) Reaction products of Aluminoxanes, Me, Me group-terminated and cycloalkylene dialkyl tetrahydro indenyl zirconium. |
| P-22-0068A | 4 | 10/04/2024 | Aditya Birla Chemicals (USA), LLC | (S) An epoxy component used in a reaction with other components to produce an epoxy article | (S) 2-Propanamine, 1,1'-[(1-methylethylidene)bis(oxy)]bis-. |
| P-23-0014A | 2 | 10/25/2024 | CBI | (G) Intermediate in production of fragrance | (G) [Polyalkyl-methylenepolyhydro-polycyclic] alkyl acetate. |
| P-23-0086A | 7 | 10/15/2024 | CBI | (G) Additive for surfactant performance enhancement; intermediate used in the manufacturing of detergents | (S) 1,2-Benzisothiazole, 3-methyl-,1,1-dioxide. |
| P-24-0006A | 7 | 10/14/2024 | CBI | (S) Oilfield Production Scale Inhibitor | (G) Propenoic acid, methyl- [phosphinicobis(oxy-ethanediyl)] ester, telomer with methyl -methyl-propenoate, (phosphonooxy) ethyl methyl-propenoate, propenoic acid, sodium methyl-[(oxo-propen-yl) amino]-propanesulfonate and sodium sulfite, sodium salt, peroxydisulfuric acid sodium salt -initiated. |
| P-24-0160A | 3 | 09/30/2024 | CBI | (G) Photoacid generator use at customer sites | (G) Iodonium, bis (dialkyl carbomonocycle) salt with alkyl carbomonocycle hetero acid. |
| P-24-0186A | 4 | 10/21/2024 | SGP Ventures, Inc. | (S) Epoxy used to fill holes in printed circuit boards | (S) 2-Oxiranemethanamine, N-[2-methyl-4-(2-oxiranylmethoxy) phenyl]-N-(2-oxiranylmethyl)-. |
| P-24-0193A | 2 | 10/10/2024 | CBI | (G) Dispersive use | (G) Perfluorosulfonic acid polymer, with perfluoro dioxolane. |
| P-24-0196 | 1 | 09/30/2024 | Toray Resin Co. | (S) Additives for architectural paints (elongation improvers) | (S) 2-Pyrrolidinone, polymer with 2-oxepanone. |
| P-24-0196A | 2 | 10/15/2024 | Toray Resin Co. | (S) Additives for architectural paints (elongation improvers) | (S) 2-Pyrrolidinone, polymer with 2-oxepanone. |
| P-25-0001A | 2 | 10/21/2024 | Polyfil, Inc. | (G) UV initiated crosslinker | (G) Alkoxy benzophenone. |
| P-25-0001A | 3 | 10/28/2024 | CBI | (G) UV crosslinker initiator | (G) Alkoxy benzophenone. |
| P-25-0003 | 1 | 10/24/2024 | CBI | (G) Contained use for microlithography for electronic device manufacturing | (G) Phenoxathiin ium, 10-phenyl-, tricycloalkylcarbomonocyclesulfonate (1:1). |
| P-25-0004 | 1 | 10/25/2024 | CBI | (G) Contained use for microlithography for electronic device manufacturing | (G) Sulfonium, triphenyl-, heteropolyclyclecarboxylate (1:1). |
| P-25-0005 | 1 | 10/28/2024 | CBI | (G) For use in coatings for metal parts | (G) Cashew, nutshell liq., polymer with [(aminoalkyl)imino] bis[alkanol], bisphenol and epichlorohydrin, reaction products with dialkanolamine, alkyl carboxylates (salts) alkanesulfonates (salts). |
| P-25-0006 | 1 | 10/28/2024 | CBI | (G) For use in coatings for metal parts | (G) Phenol, 4,4-(1-alkylidene) bis-, polymer with [(aminoalkyl)imino] bis[alkanol] and 2-(chloromethyl) oxirane, 3-alkyloxy-2-hydroxypropyl ethers, reaction products with dialkanolamine, alkyl carboxylates (salts). alkanesulfonates (salts). |
| P-25-0007 | 1 | 10/28/2024 | CBI | (G) For use in coatings for metal parts | (G) Phenol, 4,4-(1-alkylidene) bis-, polymer with [(aminoalkyl)imino] bis[alkanol] and 2-(chloromethyl) oxirane, 4-alkylphenyl ethers, reaction products with dialkanolamine, alkyl carboxylates (salts) alkanesulfonates (salts). |
| P-25-0008 | 1 | 10/28/2024 | CBI | (G) For use in coatings for metal parts | (G) Benzenediol, polymer with [(aminoalkyl)imino] bis[alkanol], 2- (chloromethyl)oxirane and 4,4-(1-alkylidene) bis[phenol], 4-alkylphenyl ethers, reaction products with dialkanolamine, alkyl carboxylates (salts) alkanesulfonates (salts). |
| P-25-0009 | 1 | 10/28/2024 | CBI | (G) For use in coatings for metal parts | (G) Cashew, nutshell liq., polymer with [(aminoalkyl)imino] bis[alkanol], bisphenol, epichlorohydrin and benzenediol, reaction products with dialkanolamine, alkyl carboxylates (salts) alkanesulfonates (salts). |
| P-25-0010 | 1 | 10/28/2024 | CBI | (G) For use in coatings for metal parts | (G) Benzenediol, polymer with [(aminoalkyl)imino] bis[alkanol], 2- (chloromethyl)oxirane and 4,4-(1-alkylidene) bis[phenol], 3-alkyloxy-2-hydroxypropyl ethers, reaction products with dialkanolamine, alkyl carboxylates (salts) alkanesulfonates (salts). |
| P-25-0012 | 1 | 10/30/2024 | Bedoukian Research, Inc. | (G) Site limited chemical intermediate | (G) Alkanoic acid, 4-bromo-, ethyl ester. |
| SN-22-0010A | 4 | 10/24/2024 | CBI | (S) Monomer chemical, reactive diluent in UV coating formulations (existing use, approved by PMN P-18-0392, additive in UV adhesive formulations (new use) | (S) 2-Oxazolidinone, 3-ethenyl-5-methyl-. |
| SN-25-0001 | 1 | 10/16/2024 | Ishihara Corporation (USA) | (S) Black pigment for architectural paint; Pigment used for non-spray applications (e.g., to make articles such as plastics, resins, fabrics, and textiles, use in adhesives) | (S) Calcium manganese titanium oxide. |
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 |
|---|---|---|---|---|
| J-24-0016 | 10/16/2024 | 09/24/2024 | N | (G) Chromosomally modified Saccharomyces cerevisiae. |
| J-24-0017 | 10/16/2024 | 09/24/2024 | N | (G) Chromosomally modified Saccharomyces cerevisiae. |
| J-24-0018 | 10/16/2024 | 09/24/2024 | N | (G) Chromosomally modified Saccharomyces cerevisiae. |
| J-24-0019 | 10/16/2024 | 09/24/2024 | N | (G) Chromosomally modified Saccharomyces cerevisiae. |
| P-20-0183 | 10/29/2024 | 10/05/2024 | N | (G) Aryl ether epoxide, homopolymer, ether with alkanolamine. |
| P-21-0181 | 10/15/2024 | 09/17/2024 | N | (S) 1,3-Benzenedicarboxamide, N1, N3-bis(3-methylphenyl)-5-[[(3-methylphenyl) amino] sulfonyl]-. |
| P-22-0095 | 10/14/2024 | 10/13/2024 | N | (G) Glycolipids. |
| P-22-0155 | 10/23/2024 | 10/14/2024 | N | (G) 2-alkyl-1,2-heteropolycycle-3-one. |
| P-23-0094 | 10/08/2024 | 09/10/2024 | N | (G) Polymer of benzenedicarboxylic acid, substituted-benzenedicarboxylic acid, branched-alkyldiol, alkyldiol and triisocyanato. |
| P-23-0164 | 10/07/2024 | 10/06/2024 | N | (S) Bismuth, 1,1',1?,1?'-(1,2-ethanediyldinitrilo) tetrakis[2-propanol] 2-(2-ethoxyethoxy) ethanol neodecanoate polypropylene glycol complexes. |
| P-23-0167 | 10/21/2024 | 09/22/2024 | N | (G) Bisalkyldiacid fluorophosphate salt. |
| P-24-0131 | 10/30/2024 | 10/28/2024 | N | (S) Heptanoic acid, 2-octyldodecyl ester. |
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-24-0191 | 10/16/2024 | Final Report | (S) 1-Propene, 1-chloro-3,3,3-trifluoro-, (1Z). |
| P-08-0200 | 10/29/2024 | Required Annual Reporting per Consent Order | (G) Partially fluorinated amphiphilic condensation polymer. |
| P-08-0643 | 10/29/2024 | Required Annual Reporting per Consent Order | (G) Fluorinated acrylic copolymer. |
| P-08-0748 | 10/29/2024 | Required Annual Reporting per Consent Order | (G) Fluorinated acrylic copolymer. |
| P-09-0245 | 10/29/2024 | Required Annual Reporting per Consent Order | (G) Partially fluorinated alcohol, reaction products with phosphorous oxide (P2O5), ammonium salts. |
| P-10-0058 | 10/29/2024 | Required Annual Reporting per Consent Order | (G) Partially fluorinated alcohol substituted glycol. |
| P-11-0091 | 10/29/2024 | Required Annual Reporting per Consent Order | (G) Fluorinated Acrylic Alkylamino Copolymer. |
| P-11-0526 | 10/29/2024 | Required Annual Reporting per Consent Order | (G) Amphoteric fluorinated surfactant. |
| P-12-0450 | 10/29/2024 | Required Annual Reporting per Consent Order | (G) Partially fluorinated alcohol, reaction products with phosphorus oxide (P2O5), amine salts. |
| P-14-0712 | 10/08/2024 | Quarterly Testing of Substance Using EPA Method 8290A | (S) Waste plastics, pyrolyzed, C5-55 fraction. |
| P-14-0712 | 10/30/2024 | Testing of Substance Described Using EPA Method 8290A | (S) Waste plastics, pyrolyzed, C5-55 fraction. |
| P-16-0543 | 10/01/2024 | Exposure Monitoring Data | (G) Halogenophosphoric acid metal salt. |
| P-16-0543 | 10/22/2024 | Exposure Monitoring Data | (G) Halogenophosphoric acid metal salt. |
| P-22-0042 | 10/02/2024 | Bacterial Reverse Mutation Test (OECD Test Guideline 471) | (G) Alkanedione, [[[(substituted)aryl] thio] aryl]-, 2-(O-acetyloxime). |
| P-22-0042 | 10/16/2024 | The summary of range finding study for OECD422 and protocol | (G) Alkanedione, [[[(substituted)aryl] thio] aryl]-, 2-(O-acetyloxime). |
| P-22-0042 | 10/18/2024 | Notice of test scheduling | (G) Alkanedione, [[[(substituted)aryl] thio] aryl]-, 2-(O-acetyloxime). |
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 21, 2024.
Pamela Myrick,
Director, Project Management and Operations Division, Office of Pollution Prevention and Toxics.
[FR Doc. 2024-27717 Filed 11-26-24; 8:45 am]
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