Environmental Protection Agency (EPA).
Section 5(g) of the Toxic Substances Control Act (TSCA) requires EPA to publish in the Federal Register a statement of its findings after its review of TSCA section 5(a) notices when EPA makes a finding that a new chemical substance or significant new use is not likely to present an unreasonable risk of injury to health or the environment. Such statements apply to premanufacture notices (PMNs), microbial commercial activity notices (MCANs), and significant new use notices (SNUNs) submitted to EPA under TSCA section 5. This document presents statements of findings made by EPA on TSCA section 5(a) notices during the period from August 1, 2019 to August 31, 2019.
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FOR FURTHER INFORMATION CONTACT:
For technical information contact: Rebecca Edelstein, Chemical Control Division (7405M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: 202-564-1667; email address: firstname.lastname@example.org.
For general information contact: The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 554-Start Printed Page 86291404; email address: TSCA-Hotline@epa.gov.
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I. General Information
A. Does this action apply to me?
This action is directed to the public in general. As such, the Agency has not attempted to describe the specific entities that this action may apply to. Although others may be affected, this action applies directly to the submitters of the PMNs addressed in this action.
B. How can I get copies of this document and other related information?
The docket for this action, identified by docket identification (ID) number EPA-HQ-OPPT-2019-0271, is available at http://www.regulations.gov or at the Office of Pollution Prevention and Toxics Docket (OPPT Docket), Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW, Washington, DC. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OPPT Docket is (202) 566-0280.
Due to the public health concerns related to COVID-19, 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.
II. What action is the Agency taking?
This document lists the statements of findings made by EPA after review of notices submitted under TSCA section 5(a) that certain new chemical substances or significant new uses are not likely to present an unreasonable risk of injury to health or the environment. This document presents statements of findings made by EPA during the period from August 1, 2019 to August 31, 2019.
III. What is the Agency's authority for taking this action?
TSCA section 5(a)(3) requires EPA to review a TSCA section 5(a) notice and make one of the following specific findings:
- The chemical substance or significant new use presents an unreasonable risk of injury to health or the environment;
- The information available to EPA is insufficient to permit a reasoned evaluation of the health and environmental effects of the chemical substance or significant new use;
- The information available to EPA is insufficient to permit a reasoned evaluation of the health and environmental effects and the chemical substance or significant new use may present an unreasonable risk of injury to health or the environment;
- The chemical substance is or will be produced in substantial quantities, and such substance either enters or may reasonably be anticipated to enter the environment in substantial quantities or there is or may be significant or substantial human exposure to the substance; or
- The chemical substance or significant new use is not likely to present an unreasonable risk of injury to health or the environment.
Unreasonable risk findings must be made without consideration of costs or other non-risk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant under the conditions of use. The term “conditions of use” is defined in TSCA section 3 to mean “the circumstances, as determined by the Administrator, under which a chemical substance is intended, known, or reasonably foreseen to be manufactured, processed, distributed in commerce, used, or disposed of.”
EPA is required under TSCA section 5(g) to publish in the Federal Register a statement of its findings after its review of TSCA section 5(a) notices (PMNs, MCANs and SNUNs) when EPA makes a finding that a new chemical substance or significant new use is not likely to present an unreasonable risk of injury to health or the environment.
Anyone who plans to manufacture (which includes import) a new chemical substance for a non-exempt commercial purpose and any manufacturer or processor wishing to engage in a use of a chemical substance designated by EPA as a significant new use must submit a notice to EPA at least 90 days before commencing manufacture or engaging in the significant new use.
The submitter of a notice to EPA for which EPA has made a finding of “not likely to present an unreasonable risk of injury to health or the environment” may commence manufacture of the chemical substance or manufacture or processing for the significant new use notwithstanding any remaining portion of the applicable review period.
IV. Statements of Administrator Findings Under TSCA Section 5(a)(3)(C)
In this unit, EPA provides the following information (to the extent that such information is not claimed as Confidential Business Information (CBI)) on the PMNs, MCANs and SNUNs for which, during this period, EPA has made findings under TSCA section 5(a)(3)(C) that the new chemical substances or significant new uses are not likely to present an unreasonable risk of injury to health or the environment:
- EPA case number assigned to the TSCA section 5(a) notice.
- Chemical identity (generic name, if the specific name is claimed as CBI).
- Website link to EPA's decision document describing the basis of the “not likely to present an unreasonable risk” finding made by EPA under TSCA section 5(a)(3)(C).
|EPA case No.||Chemical identity||Website link|
|P-19-0120||Alkenoic acid, polymer with alkanediyl bis substituted alkylene bis heteromonocycle, substituted carbomonocycle and (alkylalkenyl) carbomonocycle, alkali metal salt (generic name)||https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/tsca-section-5a3c-determination-293.|
|P-19-0118||Substituted polyalkylenepoly, reaction products with alkene polymer (generic name)||https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/tsca-section-5a3c-determination-292.|
|P-19-0099||Propanoic acid, 3-hydroxy-2-(hydroxymethyl)-2-methyl-, polymer with dimethyl carbonate, 1,2-ethanediamine, 2-ethyl-2-(hydroxymethyl)-1,3-propanediol, 1,6-hexanediol and 1,1'-methylenebis[4-isocyanatocyclohexane], compd. with N,N-diethylethanamine (CASRN: 1178511-46-0)||https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/tsca-section-5a3c-determination-291.|
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|P-19-0047||Propanoic acid, 3-hydroxy-2-(hydroxymethyl)-2-methyl-, polymer with 5-amino-1,3,3-trimethylcyclohexanemethanamine, .alpha.-hydro-.omega.-hydroxypoly(oxy-1,4-butanediyl), alpha.-hydro-.omega.-hydroxypoly[oxy(methyl-1,2-ethanediyl)], 5-isocyanato-1-(isocyanatomethyl)-1,3,3-trimethylcyclohexane and 1,1'-methylenebis[4-isocyanatobenzene], Pr alc.-blocked (CASRN: 2283318-90-9)||https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/tsca-section-5a3c-determination-290.|
|P-19-0024||Silsesquioxanes, 3-(dimethyloctadecylammonio)propyl Me Pr, polymers with silicic acid (H4Si04) tetra-Et ester, (2-hydroxyethoxy)- and methoxyterminated, chlorides (CASRN: 2231249-14-0)||https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/tsca-section-5a3c-determination-289.|
|P-18-0384||Lithium, isotope of mass 6 (CASRN: 14258-72-1)||https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/tsca-section-5a3c-determination-288.|
|P-18-0358||1H-Imidazole-1-propanenitrile, 2-ethyl-ar-methyl- (CASRN: 568591-00-4)||https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/tsca-section-5a3c-determination-287.|
|P-18-0276||Benzenesulfonamide, N-[2-[[(phenylamino)carbonyl]amino]phenyl]- (CASRN: 215917-77-4)||https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/tsca-section-5a3c-determination-286.|
|P-18-0197||Metal, alkylcarboxylate oxo complexes (generic name)||https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/tsca-section-5a3c-determination-285.|
|P-18-0172||Calcium, carbonate 2-ethylhexanoate neodecanoate propionate complex (specific name)||https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/tsca-section-5a3c-determination-284.|
|P-18-0109||2-Alkenoic acid, 2-alkyl-, alkyl ester, polymer with 2-(dialkylamino)alkyl 2-alkyl-2-alkenoate, alkyl 2-alkyl-2-alkenoate and a-(2-alkyl-1-oxo-2-alken-1-yl)-o-alkoxypoly(oxy-1,2-alkanediyl), [(1-alkoxy-2-alkyl-1-alken-1-yl)oxy]trialkylsilane-initiated (generic name)||https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/tsca-section-5a3c-determination-283.|
|P-17-0347, P-17-0348, P-17-0349, P-17-0350, P-17-0351, P-17-0352||(P-17-0347) Oxirane, 2-methyl-, polymer with oxirane, mono(2-butyloctyl) ether (CASRN:252756-20-0), (P-17-0348) oxirane, 2-methyl-, polymer with oxirane, mono(2-hexyldecyl) ether (CASRN: 125005-52-9), (P-17-0349) oxirane, 2-methyl-, polymer with oxirane, mono(2-octyldodecyl) ether (CASRN: 102640-44-8), (P-17-0350) oxirane, 2-methyl-, polymer with oxirane, mono(2-decyltetradecyl) ether (CASRN: 72484-69-6), (P-17-0351) oxirane, 2-methyl-, polymer with oxirane, mono(2-dodecylhexadecyl) ether (CASRN: 102640-42-6), (P-17-0352) oxirane, 2-methyl-, polymer with oxirane, mono(2-tetradecyloctadecyl) ether (CASRN: 102640-46-0)||https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/tsca-section-5a3c-determination-294.|
|P-16-0541||Specific: Soybean meal, reaction products with phosphoric trichloride (CASRN: 1962913-92-3)||https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/tsca-section-5a3c-determination-282.|
|P-18-0387, P-18-0388||(P-18-0387) Alkanal, reaction products with alkanediyl bis[alkyl-tris(alkyl-heterocycle)-1,3,5-triazine-2,4,6-triamine and hydrogen peroxide, (P-18-0388) 1,3,5-triazine-2,4,6-triamine, alkanediyl bis[alkyl-tris(alkyl-heterocycle)-, allyl derivs., oxidized, hydrogenated (generic names)||https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/tsca-section-5a3c-determination-281.|
|P-17-0299||2-Propenoic acid, alkyl-, polymers with alkyl acrylate and polyethylene glycol methacrylate alkyl ether (generic name)||https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/tsca-section-5a3c-determination-280.|
|P-18-0155, P-18-0156||(P-18-0155) Crosslinked polymer of alkyl acrylamides, acrylate esters, and alkyl acrylamide sulfonate salt, (P-18-0156) Crosslinked polymer of alkyl acrylamides, acrylate esters, and alkyl acrylamide sulfonic acid (generic names)||https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/tsca-section-5a3c-determination-279.|
|SN-19-0005||Functionalized multi-walled carbon nanotubes (generic name)||https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/tsca-section-5a3c-determination-278.|
|P-19-0085||Aliphatic hydrocarbons, C16-18-branched and linear (generic name)||https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/tsca-section-5a3c-determination-277.|
|P-18-0190, P-18-0191||(P-18-0190) 2,5-Furandione, polymer with ethenylbenzene, 4-hydroxy-substituted butyl amide, polymers with epichlorohydrin and trimethylolpropane, sodium salts, (P-18-0191) 2,5-Furandione, polymer with ethenylbenzene, 4-hydroxy-substituted butyl [3-[2-[1-[[(substituted phenyl)amino]carbonyl]-2-oxopropyl]diazenyl]phenyl]methyl amide, polymers with epichlorohydrin and trimthylolpropane, sodium salts (generic names)||https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/tsca-section-5a3c-determination-276.|
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Dated: October 30, 2020.
Director, New Chemicals Division, Office of Pollution Prevention and Toxics.
[FR Doc. 2021-02523 Filed 2-5-21; 8:45 am]
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