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 6/01/2024 to 6/30/2024.
DATES:
Comments identified by the specific case number provided in this document must be received on or before August 19, 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 6/01/2024 to 6/30/2024. 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
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 6/01/2024 to 6/30/2024
Case No. | Version | Received date | Manufacturer | Use | Chemical substance |
---|---|---|---|---|---|
P-22-0126A | 3 | 06/07/2024 | Takasago | (S) This polymer constitutes the wall of microcapsules containing fragrance that can be used in different homecare and personal-care applications | (S) Cellulose, polymer with 1,1′-[2-ethyl-2-[(3-mercapto-1-oxopropoxy)methyl]-1,3-propanediyl] bis(3-mercaptopropanoate) and 1,2,3-propanetriol bis(2-methyl-2-propenoate), peroxydisulfuric acid ([(HO)S(O)2]2O2) ammonium salt (1:2)- and sodium (disulfite) (2:1)-initiated. |
P-22-0149A | 4 | 06/14/2024 | Colonial Chemical, Inc. | (S) All-purpose hard surface cleaner, Low foam floor scrubber, Spray Metal Cleaning Concentrate | (S) Hexanoic acid, 3,5,5-trimethyl-, sodium salt (1:1). |
P-23-0150A | 6 | 06/19/2024 | CBI | (G) Industrial use for roll-on, brushing, and spray application | (G) Branched Glycidyl Ester and Bisphenol Glycidyl Ether polymer adduct with Aralkyl Diamine. |
P-24-0013A | 2 | 06/13/2024 | Momentive Performance Materials | (S) Resin/binder in paint formulations for industrial coatings | (G) Siloxanes and Silicones, di-Me, hydroxy-terminated, polymers with 3-[[3-alkoxy-1-(alkoxycarbonyl)-3-oxoalkyl]heteroatom] propyl Me silsesquioxanes, alkoxy-terminated. |
P-24-0040A | 3 | 06/20/2024 | Sudoc, LLC | (G) Additive for commercial, non-spray commercial and consumer applications | (G) Metal, aqua[(alkylnitrocarbocyclepolyheteropolyheterocyclopolyalkane-ketone)-polyoxidato]-, metal. |
P-24-0083A | 3 | 06/21/2024 | CBI | (G) Ingredient for cleaning products | (G) Branched alcohol alkoxylate. |
P-24-0085A | 3 | 06/04/2024 | Luna Labs | (S) Curative for polyurethane sealant | (S) Siloxanes and Silicones, di-Me, 3-[[[[4-[(4-isocyanantocyclohexyl)methyl] cyclohexyl] amino] carbonyl] oxy] propyl group terminated. |
P-24-0110A | 2 | 05/31/2024 | US Paint Corp. | (G) Component of coating | (G) Alkyl fatty acids, polymers with substituted alkene, heteromonocyclic alkenoate, substituted heteropolycyclic, substituted alkyl alkenoate, substituted alkanoic acid, carbomonocyclic dicarboxylic acid, alkyl alkenoate, alkyl alkenoate, alkenoic acid, substituted carbomonocycle, and trisubstituted alkyl, alkyl substituted alkyl alkanoate and substituted bis alkylalkanenitrile-initiated. |
P-24-0114A | 2 | 05/31/2024 | HPC Holdings, Inc. | (G) Chemical Intermediate | (S) 1,3-Butanediol, 4,4,4-trifluoro-3-(trifluoromethyl)-. |
P-24-0125 | 1 | 04/17/2024 | CBI | (G) Plasticizer Additive | (G) Dialkyl carbomonocyclodiate. |
P-24-0128A | 4 | 06/06/2024 | CBI | (S) Chemical intermediate | (G) Tetramethyldisiloxanediylbis[propylcarbonyl]. |
P-24-0132A | 2 | 06/11/2024 | CBI | (G) Sizing agent | (S) Sunflower oil, oleic acid-high, maleated. |
P-24-0137 | 1 | 04/19/2024 | KAO Specialties Americas, LLC | (G) Component of liquid detergent | (G) Alkene, reaction products with oxide, hydrolyzed, alkali metal salts. |
P-24-0160A | 2 | 06/05/2024 | CBI | (G) Photoacid generator use at customer sites | (G) Iodonium, bis(dialkyl carbomonocycle) salt with alkyl carbomonocycle hetero-acid. |
P-24-0163A | 2 | 06/13/2024 | CBI | (G) Gas adsorption cartridges. Protective Garments | (G) Transition metal polykis (heteroatom substituted carbomonocycle), hydroxy- oxo-. |
P-24-0164 | 1 | 06/13/2024 | Huntsman International, LLC | (S) Intermediate in the production of a catalyst | (S) 2-Propanamine, N ,N ′-(oxydi-2,1-ethanediyl)bis-. |
P-24-0166 | 1 | 06/24/2024 | Nagase America, LLC | (S) Heat transfer fluid in a cooling system for a reaction chamber | (S) Pentane, 1,1,2,2,3,3,4,4-octafluoro-5-(1,1,2,2-tetrafluoroethoxy)-. |
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 6/01/2024 to 6/30/2024
Case No. | Received date | Commencement date | If amendment, type of amendment | Chemical substance |
---|---|---|---|---|
J-24-0009 | 06/03/2024 | 05/30/2024 | N | (G) Chromosomally-modified saccharomyces cerevisiae. |
J-24-0010 | 06/03/2024 | 05/30/2024 | N | (G) Chromosomally modified saccharomyces cerevisiae. |
J-24-0011 | 06/03/2024 | 05/30/2024 | N | (G) Chromosomally modified saccharomyces cerevisiae. |
J-24-0012 | 06/03/2024 | 05/30/2024 | N | (G) Chromosomally-modified saccharomyces cerevisiae. |
J-24-0013 | 06/03/2024 | 05/30/2024 | N | (G) Chromosomally-modified saccharomyces cerevisiae. |
P-15-0446 | 06/10/2024 | 06/05/2024 | N | (G) Rare earth doped zirconium oxide. |
P-17-0235A | 05/31/2024 | 11/28/2022 | Amended the generic chemical name | (G) Fatty amidopropyl trialkyl ammonium alkyl sulfate. |
P-18-0226 | 05/31/2024 | 03/04/2024 | N | (G) Trialkylammonioethyl fatty-alkylate, alkyl sulfate. |
P-19-0166A | 06/14/2024 | 06/27/2022 | Amended the generic chemical name | (G) Triaryl sulfonium, multicycloalkylalkoxycarbonyloxymonofluoroalkylsulfonate. |
P-22-0025 | 06/19/2024 | 06/10/2024 | N | (G) Oxirane, 2-(chloromethyl)-, homopolymer, ether with dialkyl-alkanediol (2:1). |
P-22-0090 | 06/14/2024 | 05/21/2024 | N | (S) 4,8,11-dodecatrienal. |
P-22-0093 | 06/03/2024 | 05/24/2024 | N | (G) Alkenoic acid, alkyl-substituted alkyl ester, polymer with (polyalkylamino)alkyl alkylalkenoate, alkyl-substituted alkylalkenoate, alpha-(alkyl-oxoalkenyl)-omega-alkoxypoly(oxy-1,2-ethanediyl), [(alkoxy-alkyl-alkenyl)oxy]polyalkylsilane-initiated, compds. with polyethylene glycol phosphoric acid based alkyl ether. |
P-22-0175 | 06/06/2024 | 05/23/2024 | N | (G) Modified silsesquioxane, alkoxy-terminated. |
P-87-1177 | 06/20/2024 | 03/21/1990 | N | (G) Siloxanes and silicones, di-me, vinyl group-terminated, reaction products with trisiladioxadimethoxyalkanes. |
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 6/01/2024 to 6/30/2024
Case No. | Received date | Type of test information | Chemical substance |
---|---|---|---|
L-24-0235 | 06/20/2024 | Bioconcentration Factor Predictions; Bacterial Reverse Mutation Test (OECD Test Guideline 471); Prenatal Developmental Toxicity Study (OECD Test Guideline 414); Carcinogenicity (OECD Test Guideline 451); Acute Dermal Toxicity (OECD Test Guideline 402); Skin Sensitization (OECD Test Guideline 406); Acute Dermal Irritation (OECD Test Guideline 404); Acute Eye Irritation (OECD Test Guideline 405); Chromosomal Aberration Testing | (G) Diisopropyl imidazolium salt. |
P-12-0241 | 06/21/2024 | Analyte Reports | (G) [2-Propenoic acid, 2-methyl-, 2-hydroxyethyl esters, telomers with c18-26-alkyl acrylate, 1-dodecanethiol, N-(hydroxymethyl)-2-methyl-2- propenamide, 3,3,4,4,5,5,6,6,7,7,8,8,8-tridecaflourooctyl methacrylate, 2,2-[1,2 diazenedylbis(1-methylethylidene)]bis[4,5-dihydro-1Himidazole]hydrochloride (1:2)-initiated]. |
P-14-0712 | 06/27/2024 | Polychlorinated Dibenzodioxins and Polychlorinated dibenzofurans Testing | (S) Waste plastics, pyrolyzed, C5-55 fraction. |
P-16-0543 | 06/25/2024 | Exposure Monitoring Report | (G) Halogenophosphoric acid metal salt. |
P-21-0166 | 06/20/2024 | Gel Permeation Chromatography Testing | (G) Siloxanes and silicones, di-me, [alkylpiperazinium-hydroxyalkoxy]alkyl group-terminated, arylsulfonates (salts). |
P-21-0180, P-22-0086, P-22-0122, P-22-0179, P-22-0180, P-24-0097 | 6/20/2024 | Determination of Dissociation Constant (Conductometric Method) | (G) Sulfonium, (halocarbomonocycle)diphenyl-, salt with 1-heterosubstituted-2-methylalkyl trihalobenzoate (1:1); (G) Phenoxathiinium, 10-phenyl-, 5-alkyl-2-alkyl-4-(2,4,6-substituted tri- carbopolycycle, hetero-acid)benzenesulfonate (1:1); (G) Heterotrisubstituted-bile acid, 1-(difluorosulfomethyl)-2,2,2-trifluoroethyl ester, ion(1-), (5)-, 5-phenyldibenzothiophenium(1:1); (G) Sulfonium, (alkylsubstitutedphenyl)diphenyl-, salt with 1-(heterosubstitutedalkyl)-2,2,2-triheterosubstitutedalkyl trisubstitutedbenzoate (1:1); (G) Dibenzothiophenium, 5-phenyl-, 4-[1-(heterosubstitutedalkyl)-2,2,2-triheterosubstitutedalkoxy]-4-oxoalkyl trisubstitutedbenzoate (1:1); (G) Sulfonium, tris(4-fluorophenyl)-, (substitutedphenoxy)alkyl substitutedbenzoate (1:1). |
P-21-0202, P-23-0104 | 06/07/2024 | Determination of Water Solubility (Shake Flask Method) | (G) Sulfonium, carbomonocycle bis[(trihaloalkyl)carbomonocycle], substituted carbomonocyclic ester; (G) Sulfonium, carbomonocycle bis[(trihaloalkyl)carbomonocycle], disubstituted carbomonocyclic ester. |
P-22-0056 | 06/25/2024 | Determination of Tin in Dermal Penetration Media Samples Validation | (S) Tin, dioctylbis(2,4-pentanedionato-.kappa.o2,.kappa.o4)-. |
P-22-0086 | 06/20/2024 | Dissociation Constants in Water (OECD Test Guideline 112) | (G) Phenoxathiinium, 10-phenyl-, 5-alkyl-2-alkyl-4-(2,4,6-substituted tri- carbopolycycle, hetero-acid)benzenesulfonate (1:1). |
P-22-0122 | 06/20/2024 | Dissociation Constants in Water (OECD Test Guideline 112) | (G) Heterotrisubstituted-bile acid, 1-(difluorosulfomethyl)-2,2,2-trifluoroethyl ester, ion(1-), (5)-, 5-phenyldibenzothiophenium(1:1). |
P-24-0137 | 04/19/2024 | Acute Eye Irritation (OECD Test Guideline 405); Combined Repeated Dose Toxicity with the Reproduction/Development Toxicity Screening Test (OECD Test Guideline 422); Earthworm, Acute Toxicity Tests (OECD Test Guideline 207); Daphnia sp., Acute Immobilization Test (OECD Test Guideline 202); Daphnia magna Reproduction Test (OECD Test Guideline 211); Freshwater and Saltwater Fish Acute Toxicity Test (OECD Test Guideline 203); In Vitro Mammalian Cell Gene Mutation Test (OECD Test Guideline 476); Mammalian Spermatogonial Chromosomal Aberration Test (OECD Test Guideline 483); Prenatal Developmental Toxicity Study (OECD Test Guideline 414); | (G) Alkene, reaction products with oxide, hydrolyzed, alkali metal salts. |
Inherent Biodegradability—Concawe Test (OCSPP Test Guideline 835.3215); Ready Biodegradability (OECD Test Guideline 301); Fish Short-Term Reproduction (OECD Test Guideline 299); Seed Germination/Root Elongation Toxicity Test (OPPTS Test Guideline 850.4200); Sediment-Water Chironomid Toxicity Test Using Spiked Sediment (OECD Test Guideline 218); Skin Sensitization (OECD Test Guideline 406); 90-Day Oral Toxicity in Rodents (OECD Test Guideline 408); Modified Activated Sludge, Respiration Inhibition Test (OCSPP Test Guideline 850.3300); Acute Dermal Irritation (OECD Test Guideline 404); Acute Dermal Toxicity/Pathology (OCSPP Test Guideline 885.3100); Acute Oral Toxicity/Pathogenicity (OCSPP Test Guideline 885.3050); Algal Toxicity (OECD Test Guideline 201); Adsorption/Desorption (Batch Equilibrium) (OECD Test Guideline 106); Bacterial Reverse Mutation Test (OECD Test Guideline 471) |
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: July 15, 2024.
Pamela Myrick,
Director, Project Management and Operations Division, Office of Pollution Prevention and Toxics.
[FR Doc. 2024-15856 Filed 7-17-24; 8:45 am]
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