2021-02525. Certain New Chemicals or Significant New Uses; Statements of Findings for September Through December 2019

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

The Toxic Substances Control Act (TSCA) requires EPA to publish in the Federal Register a statement of its findings after its review of certain TSCA 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. This document presents statements of findings made by EPA on such submissions during the period from September 1, 2019 to December 31, 2019.

FOR FURTHER INFORMATION CONTACT:

For technical information contact: Rebecca Edelstein, New Chemicals 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: [e-mail].

For general information contact: The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone number: [phone]; email address: [e-mail].

SUPPLEMENTARY INFORMATION:

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 [phone], and the telephone number for the OPPT Docket is [phone].

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 September 1, 2019 to December 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 a TSCA section 5(a) notice 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 PMNs, MCANs, and SNUNs submitted to EPA under TSCA section 5.

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 of the new chemical substance or before 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 address 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 address
J-19-0024, J-19-0025	Biofuel producing Saccharomyces cerevisiae modified, genetically stable (generic name)	https://www.epa.gov/​reviewing-new-chemicals-under-toxic-substances-control-act-tsca/​tsca-section-5a3c-determination-296.
P-15-0632	Mixed amine salt (generic name)	https://www.epa.gov/​reviewing-new-chemicals-under-toxic-substances-control-act-tsca/​tsca-section-5a3c-determination-327.
P-16-0291	1,3-cyclohexanedimethanamine adduct (generic name)	https://www.epa.gov/​reviewing-new-chemicals-under-toxic-substances-control-act-tsca/​tsca-section-5a3c-determination-331.
P-16-0451	Reaction product of bisalkoxysilylalkylamine, alkoxy oxiranylalkoxyalkylsilane and silica (generic name)	https://www.epa.gov/​reviewing-new-chemicals-under-toxic-substances-control-act-tsca/​tsca-section-5a3c-determination-329.
P-16-0486	Polychloropropane (generic name)	https://www.epa.gov/​reviewing-new-chemicals-under-toxic-substances-control-act-tsca/​tsca-section-5a3c-determination-330.
P-17-0109	Alkyldiamine, aminoalkyl dimethylaminoalkyl dimethyl-(generic name)	https://www.epa.gov/​reviewing-new-chemicals-under-toxic-substances-control-act-tsca/​tsca-section-5a3c-determination-313.
P-17-0184	1-Propanaminium, 2-hydroxy-N,N-dimethyl-N-[3-[(1-oxooctyl)amino]propyl]-3-sulfo-, inner salt (CASRN 1612795-77-3)	https://www.epa.gov/​reviewing-new-chemicals-under-toxic-substances-control-act-tsca/​tsca-section-5a3c-determination-328.
P-17-0233	Oxyalkylene modified polyalkyl amine alkyl diacid polymer with 2-(chloromethyl)oxirane (generic name)	https://www.epa.gov/​reviewing-new-chemicals-under-toxic-substances-control-act-tsca/​tsca-section-5a3c-determination-352.
P-17-0234	Oxirane, 2-(chloromethyl)-, polymer with 2-methyloxirane polymer with oxirane bis(2-aminopropyl) ether (CASRN: 78390-60-0)	https://www.epa.gov/​reviewing-new-chemicals-under-toxic-substances-control-act-tsca/​tsca-section-5a3c-determination-351.
P-17-0298	Formaldehyde, homopolymer, reaction products with N-propyl-1-propanamine (CASRN: 1374859-50-3)	https://www.epa.gov/​reviewing-new-chemicals-under-toxic-substances-control-act-tsca/​tsca-section-5a3c-determination-340.
P-17-0325	2-Propenoic acid, polymer with 2-methyl-2-((1-oxo-2-propenyl)amino)-1-propanesulfonic acid (CASRN: 40623-75-4)	https://www.epa.gov/​reviewing-new-chemicals-under-toxic-substances-control-act-tsca/​tsca-section-5a3c-determination-342.
P-17-0360	2-Propanol, 1-amino-, compd. with .alpha.-sulfo-.omega.-(octyloxy)poly(oxy-1,2-ethanediyl) (1:1), CASRN 2098904-74-4; 2-Propanol, 1-amino-, compd. with .alpha.-sulfo- .omega.-(decyloxy)poly(oxy-1,2-ethanediyl) (1:1) (CASRN 2098904-80-2)	https://www.epa.gov/​reviewing-new-chemicals-under-toxic-substances-control-act-tsca/​tsca-section-5a3c-determination-315.
P-17-0396	Aminoalkylated imidazole (generic name)	https://www.epa.gov/​reviewing-new-chemicals-under-toxic-substances-control-act-tsca/​tsca-section-5a3c-determination-319.
P-17-0400	Terpolymer of vinylidene fluoride, tetrafluoroehylene and 2,3,3,3-tetrafluoropropene (generic name)	https://www.epa.gov/​reviewing-new-chemicals-under-toxic-substances-control-act-tsca/​tsca-section-5a3c-determination-337.
P-18-0019	Substituted Benzene, 4-[2-[2-hydroxy-3-[[(3-nitrophenyl)amino]carbonyl]-1-naphthalenyl]diazenyl]-, sodium salt (1:1) (generic name)	https://www.epa.gov/​reviewing-new-chemicals-under-toxic-substances-control-act-tsca/​tsca-section-5a3c-determination-317.
P-18-0029	Fatty acids and fatty acid unsatd., reaction products with ethyleneamines and maleic anhydride (generic name)	https://www.epa.gov/​reviewing-new-chemicals-under-toxic-substances-control-act-tsca/​tsca-section-5a3c-determination-318.
P-18-0034	Polyetheramine carboxylate salt (generic name)	https://www.epa.gov/​reviewing-new-chemicals-under-toxic-substances-control-act-tsca/​tsca-section-5a3c-determination-298.
P-18-0092	Phosphonium, tributylmethyl-, iodide (1:1) (CASRN: 1702-42-7)	https://www.epa.gov/​reviewing-new-chemicals-under-toxic-substances-control-act-tsca/​tsca-section-5a3c-determination-314.
P-18-0105	Phosphorous acid, triisotridecyl ester (CASRN: 77745-66-5)	https://www.epa.gov/​reviewing-new-chemicals-under-toxic-substances-control-act-tsca/​tsca-section-5a3c-determination-299.
P-18-0114	Propanoic acid, hydroxy- (hydroxyalkyl)-alkyl-, polymer with 1,6-diisocyanatoalkane and poly[oxy(alkyl-alkanediyl)] ether with alkyl-(hydroxyalkyl)-alkanediol, 2-propenoate (ester), lithium salt, glycerol monoacrylate 1-neodecanoate- and alkylene glycol monoacrylate-blocked (generic name)	https://www.epa.gov/​reviewing-new-chemicals-under-toxic-substances-control-act-tsca/​tsca-section-5a3c-determination-343.
P-18-0121	Benzene, 1,1′-oxybis-, branched eicosyl derivs. (CASRN 1800419-55-9)	https://www.epa.gov/​reviewing-new-chemicals-under-toxic-substances-control-act-tsca/​tsca-section-5a3c-determination-316.
P-18-0133	Polyol adduct of bisaldehyde (generic name)	https://www.epa.gov/​reviewing-new-chemicals-under-toxic-substances-control-act-tsca/​tsca-section-5a3c-determination-335.
P-18-0165, P-18-0166	(P-18-0165) 2,5-Furandione, polymer with ethenylbenzene, 4-hydroxy-substituted butyl amide, sodium salts; (P-18-0166) 2,5-Furandione, polymer with ethenylbenzene, 4-hydroxy-substituted butyl [3-[2-[1-[[(2-methoxyphenyl)amino]carbonyl]-2-oxopropyl]diazenyl]phenyl]substituted, sodium salts (generic names)	https://www.epa.gov/​reviewing-new-chemicals-under-toxic-substances-control-act-tsca/​tsca-section-5a3c-determination-321.
P-18-0167	Butanamide, 2-[2-[(substituted phenyl)diazenyl]-N-(2-methoxyphenyl)-3-oxo- (generic name)	https://www.epa.gov/​reviewing-new-chemicals-under-toxic-substances-control-act-tsca/​tsca-section-5a3c-determination-322.
P-18-0192	Benzenesulfonic acid, (alkenediyl)bis[[[(hydroxyalkyl)amino]-(phenylamino)-triazin-2-yl]amino]-, N-(hydroxyalkyl) derivs., salts, compds. with polyalkyl-substituted(alkanol) (generic name)	https://www.epa.gov/​reviewing-new-chemicals-under-toxic-substances-control-act-tsca/​tsca-section-5a3c-determination-297.
P-18-0207	Metal, oxo alkylcarboxylate complexes (generic name)	https://www.epa.gov/​reviewing-new-chemicals-under-toxic-substances-control-act-tsca/​tsca-section-5a3c-determination-311.
P-18-0213	1,3-Benzenedicarboxylic acid, 5-sulfo-, calcium salt (2:1) (CASRN 24806-09-5)	https://www.epa.gov/​reviewing-new-chemicals-under-toxic-substances-control-act-tsca/​tsca-section-5a3c-determination-323.
P-18-0214, P-18-0215, P-18-0216	(P-18-0214) Polycyclic substituted alkane, polymer with cyclicalkylamine, epoxide, and polycyclic epoxide ether, reaction products with dialkylamine substituted alkyl amine; (P-18-0215) Polycyclic alkane, polymer with monocyclic amine, polycyclic epoxide ether, reaction products with dialkylamine alkyl amine; (P-18-0216) Polycyclic substituted alkane, polymer with epoxide, reaction products with cyclicalkylamine and dialkylamine substituted alkyl amine (generic names)	https://www.epa.gov/​reviewing-new-chemicals-under-toxic-substances-control-act-tsca/​tsca-section-5a3c-determination-336.
P-18-0232	Polyol, reaction products with formaldehyde and methanol (generic name)	https://www.epa.gov/​reviewing-new-chemicals-under-toxic-substances-control-act-tsca/​tsca-section-5a3c-determination-341.
P-18-0258, P-18-0259	(P-18-0258) Dioic acids, polymers with caprolactam and alkyldiamines; (P-18-0259) Fatty acids, dimers, hydrogenated, polymers with caprolactam and alkyldiamine (generic names)	https://www.epa.gov/​reviewing-new-chemicals-under-toxic-substances-control-act-tsca/​tsca-section-5a3c-determination-320.
P-18-0264	Phosphonomethylated ether diamine (generic name)	https://www.epa.gov/​reviewing-new-chemicals-under-toxic-substances-control-act-tsca/​tsca-section-5a3c-determination-332.
P-18-0295	1,3-Butanediol, (3R)-(CASRN: 6290-03-5)	https://www.epa.gov/​reviewing-new-chemicals-under-toxic-substances-control-act-tsca/​tsca-section-5a3c-determination-300.
P-18-0299	Alkenoic acid, alkyl-, polymers with alkyl methacrylate, cycloalkyl methacrylate, alkylene dimethacrylate, and polyalkene glycol hydrogen sulfate [(branched alkyloxy)alkyl]-(alkenyloxy)alkyl ethers ammonium salts, metal salts (generic name)	https://www.epa.gov/​reviewing-new-chemicals-under-toxic-substances-control-act-tsca/​tsca-section-5a3c-determination-301.
P-18-0302	D-Glucaric acid, ammonium salt (1:1) (CASRN: 6614-39-7)	https://www.epa.gov/​reviewing-new-chemicals-under-toxic-substances-control-act-tsca/​tsca-section-5a3c-determination-310.
P-18-0329	Substituted carbopolycyclic dicarboxylic acid dialkyl ester, polymer with alkanediol and carbopolycyclic bis (substituted carbopolycycle) bisalkanol (generic name)	https://www.epa.gov/​reviewing-new-chemicals-under-toxic-substances-control-act-tsca/​tsca-section-5a3c-determination-344.
P-18-0341, P-18-0342, P-18-0343, P-18-0344	(P-18-0341) Alkane dicarboxylic acid, polymer with alkoxylated polyalcohol , alkyl polyglycol, alkyl dialcohol, and functionalized carboxylic acid; (P-18-0342) Alkane dicarboxylic acid, polymer with alkyl polyglycol, alkyl dialcohol, and functionalized carboxylic acid; (P-18-0343) Alkane dicarboxylic acid, polymer with alkoxylated polyalcohol, and alkyl dialcohol, (hydroxy alkyl) ester; (P-18-0344) Aromatic dicarboxylic acid, polymer with alkane dicarboxylic acid, alkoxylated polyalcohol, and alkyl dialcohol (generic names)	https://www.epa.gov/​reviewing-new-chemicals-under-toxic-substances-control-act-tsca/​tsca-section-5a3c-determination-345.
P-18-0385	D-Glucopyranose, oligomeric, Bu glycosides, polymers with epichlorohydrin, 2-hydroxy-3-sulfopropyl ethers, sodium salts (CASRN: 2139271-53-5)	https://www.epa.gov/​reviewing-new-chemicals-under-toxic-substances-control-act-tsca/​tsca-section-5a3c-determination-333.
P-18-0392	Heteromonocycle, alkenyl alkyl (generic name)	https://www.epa.gov/​reviewing-new-chemicals-under-toxic-substances-control-act-tsca/​tsca-section-5a3c-determination-334.
P-18-0393	Alkenoic acid, alkyl, alkyl ester, polymer with alkyl propenoate, vinyl carbomonocyle, substituted alkyl propenoate, alkyl 2-alkyl 2-propenoate, alkanediol mono(2-alkyl-2-propenoate) and bicarbomonocylo alkyl 2-alkyl-2-alkenoate, tertiary alkyl substituted alkane peroxoate initiated (polymer exemption flag) (generic name)	https://www.epa.gov/​reviewing-new-chemicals-under-toxic-substances-control-act-tsca/​tsca-section-5a3c-determination-346.
P-19-0058	Butanoic acid, 3-oxo-, 2-[(2-methyl-1-oxo-2-propen-1-yl)oxy]ethyl ester, polymer with butyl 2-propenoate, ethenylbenzene, methyl 2-methyl-2-propenoate and 2-methyl-2-popenoic acid, ammonium salt (CASRN 2131811-80-6) (polymer exemption flag)	https://www.epa.gov/​reviewing-new-chemicals-under-toxic-substances-control-act-tsca/​tsca-section-5a3c-determination-324.
P-19-0113	Metal oxide-chloro (generic name)	https://www.epa.gov/​reviewing-new-chemicals-under-toxic-substances-control-act-tsca/​tsca-section-5a3c-determination-302.
P-19-0117	Polycyclic amine, reaction products with polyalkylalkene, polymers (generic name)	https://www.epa.gov/​reviewing-new-chemicals-under-toxic-substances-control-act-tsca/​tsca-section-5a3c-determination-303.
P-19-0121	Plant based oils, polymer with 1,1′-methylenebis[4-isocyanatobenzene], pentaerythritol, phthalic esters, polypropylene glycol and polypropylene glycol ether with glycerol (3:1) (generic name)	https://www.epa.gov/​reviewing-new-chemicals-under-toxic-substances-control-act-tsca/​tsca-section-5a3c-determination-304.
P-19-0130	Aminohydroxy naphthalenesulfonic acid, coupled with diazotized[(aminophenyl) sulfonyl]ethyl hydrogen sulfate and diazotized amino[[(sulfooxy)ethyl]sulfonyl]benzenesulfonic acid, salts (generic name)	https://www.epa.gov/​reviewing-new-chemicals-under-toxic-substances-control-act-tsca/​tsca-section-5a3c-determination-305.
P-19-0132	Fatty acid, polymer with alkanedioic acid dialkyl ester, alkanoic acid, oxo alkyl ester, substituted carbomonocycle, alkyl substituted alkanediol, and alkylol substituted alkane (generic name)	https://www.epa.gov/​reviewing-new-chemicals-under-toxic-substances-control-act-tsca/​tsca-section-5a3c-determination-306.
P-19-0135	Alkyl polyoxyethylene ethers, carboxymethylated (generic name)	https://www.epa.gov/​reviewing-new-chemicals-under-toxic-substances-control-act-tsca/​tsca-section-5a3c-determination-347.
P-19-0137	Alkyl oligomeric reaction products (generic name)	https://www.epa.gov/​reviewing-new-chemicals-under-toxic-substances-control-act-tsca/​tsca-section-5a3c-determination-307.
P-19-0146	Modified dimethyl sulfoxide (generic name)	https://www.epa.gov/​reviewing-new-chemicals-under-toxic-substances-control-act-tsca/​tsca-section-5a3c-determination-325.
P-19-0148, P-19-0149, P-19-0150, P-19-0151	(P-19-0148) Iron, complexes with ethylenediamine-4-hydroxycarbomonocycle hetero-acid-2-oxoacetic acid reaction products, potassium salts; (P-19-0149) Iron, complexes with ethylenediamine-4-hydroxycarbomonocycle hetero-acid potassium salt (1:1)-potassium 2-oxoacetate (1:1) reaction products, potassium salts; (P-19-0150) Iron, complexes with ethylenediamine-4-hydroxycarbomonocycle hetero-acid-2-oxoacetic acid reaction products, sodium salts; (P-19-0151) Iron, complexes with ethylenediamine-4-hydroxycarbomonocycle hetero-acid sodium salt (1:1)-sodium 2-oxoacetate (1:1) reaction products, sodium salts (generic names)	https://www.epa.gov/​reviewing-new-chemicals-under-toxic-substances-control-act-tsca/​tsca-section-5a3c-determination-349.
P-19-0152	Alkaneic acid, dialkyl ester polymer with alkanediol, [[(isocyanatocarbomonocycle) alkyl]carbomonocycle]carbamate (generic name)	https://www.epa.gov/​reviewing-new-chemicals-under-toxic-substances-control-act-tsca/​tsca-section-5a3c-determination-326.
P-19-0155, P-19-0156, P-19-0157	(P-19-0155) Amides, from C8-18 and C18-unsatd. glycerides and diethylenetriamine, ethoxylated (CASRN: 2173332-72-2); (P-19-0156) Amides, from diethylenetriamine and palm kernel-oil, ethoxylated (CASRN: 2173332-69-7); (P-19-0157) Amides, from coconut oil and diethylenetriamine, ethoxylated (CASRN: 2173332-70-0)	https://www.epa.gov/​reviewing-new-chemicals-under-toxic-substances-control-act-tsca/​tsca-section-5a3c-determination-350.
P-20-0002	Fatty Acids, C18-unsatd., dimers, hydrogenated, polymers with .alpha-.hydro-.omega.-hydroxypoly(oxy-1,4-butanediyl) and nonanoic acid (CASRN 2359671-57-9)	https://www.epa.gov/​reviewing-new-chemicals-under-toxic-substances-control-act-tsca/​tsca-section-5a3c-determination-339.
P-20-0004	Fatty Acids, C18-unsatd., dimers, hydrogenated, polymers with hexanoic acid and .alpha.-hydro-.omega.hydroxypoly(oxy-1,4-butanediyl) (CASRN: 2359671-53-5)	https://www.epa.gov/​reviewing-new-chemicals-under-toxic-substances-control-act-tsca/​tsca-section-5a3c-determination-338.
SN-18-0005	Butanoic acid, 3-mercapto-,1,1′-[2-(hydroxymethyl)-2-[(3-mercapto-1-oxobutoxy)methyl]-1,3-propanediyl] ester; CASRN: 1027326-93-7; and Butanoic acid, 3-mercapto-,1,1′-[2,2-bis[(3-mercapto-1-oxobutoxy)methyl]-1,3-propanediyl] ester (CASRN: 31775-89-0)	https://www.epa.gov/​reviewing-new-chemicals-under-toxic-substances-control-act-tsca/​tsca-section-5a3c-determination-308.
SN-19-0004	Coke (coal), secondary pitch (CASRN: 94113-91-4)	https://www.epa.gov/​reviewing-new-chemicals-under-toxic-substances-control-act-tsca/​tsca-section-5a3c-determination-309.

(Authority: 15 U.S.C. 2601 et seq.)

Dated: November 6, 2020.

Madison Le,

Director, New Chemicals Division, Office of Pollution Prevention and Toxics.