# Certain New Chemicals or Significant New Uses; Statements of Findings for April 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 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 April 1, 2019 to April 30, 2019.
**FOR FURTHER INFORMATION CONTACT:**
*For technical information contact:* Greg Schweer, Chemical Control Division (7405M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: 202-564-8469; email address: *[email protected].*
*For general information contact:* The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 554-1404; email address: *[email protected].*
**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-2018-0097, 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. Please review the visitor instructions and additional information about the docket available at *http://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 April 1, 2019 to April 30, 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 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-19-0020 | Alkylphenol, reaction products with carbon dioxide, distn. residues from manuf. of alkylphenol derivs. and calcium alkylphenol derivs. (generic name) | |
| P-18-0247-0252 | (P-18-0247) Isocyanic acid, polymethylenepolyphenylene ester, polymer with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol, polyetherpolyol, .alpha.,alpha.′-[(1- methylethylidene)di-4,1-phenylene]bis[.omega.-hydroxypoly(oxy-1,2-ethanediyl)] and 1,2-propanediol, iso-Bu alc.- and 2-butoxyethanol- and 2-(2-butoxyethoxy)ethanol- and Et alc.- and methanol- and 1-methoxy-2-propanol-blocked (generic name), (P-18-248) Isocyanic acid, polymethylenepolyphenylene ester, polymer with polyetherpolyol, 2-butoxyethanol- and 2-(2-butoxyethoxy)ethanol- and methanol blocked (generic name), (P-18-249) Isocyanic acid, polymethylenepolyphenylene ester, polymer with polyetherpolyol, 2-butoxyethanol- and 2-(2-butoxyethoxy)ethanol- and methanol and 1-methoxy-2-propanol-blocked (generic name), (P-18-0250) Isocyanic acid, polymethylenepolyphenylene ester, polymer with polyetherpolyol, 2-butoxyethanol- and 2-(2-butoxyethoxy)ethanol- and 1(or2)-(2-methoxymethylethoxy)propanol-blocked (generic name), (P-18-0251) Isocyanic acid, polymethylenepolyphenylene ester, 2-butoxyethanol- and 2-(2-butoxyethoxy)ethanol- and methanol- and 1(or2)-(2-methoxymethylethoxy)propanol-blocked (specific name), (P-18-0252) Isocyanic acid, polymethylenepolyphenylene ester, 2-butoxyethanol- and 2-(2-butoxyethoxy)ethanol- and methanol- and 1-methoxy-2-propanol-blocked (specific name) | |
| P-17-0253 | Oxirane, 2-methyl-, polymer with oxirane, methyl 2-(substituted carbomonocycle isoquinolin-2(3H)-yl) propyl ether (generic name) | |
| P-17-0245 | Unsaturated polyfluoro ester (generic name) | |
| P-17-0152 | Poly-(2-methyl-1-oxo-2-propen-1-yl) ester with Ethanaminium, N,N,N-trialkyl, chloride and methoxypoly(oxy-1,2-ethanediyl) (generic name) | |
| P-16-0422 | 1,2-Cyclohexanedicarboxylic acid, 1-(phenylmethyl) ester, ester with 2,2,4-trimethyl-1,3-pentanediol mono(2-methylpropanoate) (CASRN: 1661012-65-2) | |
| P-14-0482 | Organic salt (generic name) | |
| P-19-0046 | 1,2,4-Benzenetricarboxylic acid, mixed decyl and octyl triesters (CASRN: 90218-76-1) | |
| P-18-0266 | Alkanes, C20-45 branched and linear (CASRN: 2133415-24-2) | |
| P-18-0305 | Alkenoic acid, alkyl-,alkyl ester, polymer with alkyl alkenoate, substituted heteromonocycycle, substituted carbomonocycle, substituted alkanediol and alkenoic acid, alkali metal salt (generic name) | |
| P-18-0186 | Polyolefin ester (generic name) | |
| J-19-0012-0015 | Biofuel producing
modified, genetically stable (generic name) | |
| J-19-0017 | Genetically modified microorganism for the production of a chemical substance (generic name) | |
| J-19-0011 | Genetically modified microorganism for the production of a chemical substance (generic name) | |
| P-19-0045 | Non-metal tetrakis (hydroxyalkyl)-, halide, polymer with amide oxidized (generic name) | |
| P-19-0032 | Carbonic dichloride, polymer with 4,4′-(1-methylethylidene)bis[phenol] ester, polymer with tetrol and polyether tetrol (generic name) | |
| P-19-0030 | Triethanolamine modified Phosphinicocarboxylates, sodium salts (generic name) | |
| P-18-0375 | Fats and Glyceridic oils, vegetable, sulfonated, sodium salts (CASRN: 97489-04-8) | |
| P-18-0312 | Formaldehyde, polymer with 2-phenoxyalkanol and .alpha.-phenyl-.omega. hydroxypoly(oxy-1,2-alkylnediyl), dihydrogen phosphate 2-phenoxyalkyl hydrogen phosphate, alkaline salt (generic name) | |
| P-18-0122 | Alkylamide, polymer with alkylamine, formaldehyde, and polycyanamide, alkyl acid salt (generic name) | |
| P-19-0040 | Alkyl bis(dialkylamino alkyl) amide (generic name) | |
| P-19-0010 | Hydrogenated fatty acid dimers, polymers with 1,1′-methylenebis[4-isocyanatobenzene], polypropylene glycol, polypropylene glycol ether with trimethylolpropane (3:1), and 1,3-propanediol, propylene glycol monomethacrylate-blocked (generic name) | |
| P-18-0222 | Silane, alkenylalkoxy-, polymer with alkene and alkene (generic name) | |
| P-18-0162 | Cashew nutshell liquid, polymer with diisocyanatoalkane, substituted-polyoxyalkyldiol and polyether polyol (generic name) | |
| P-17-0239 | Substituted carboxylic acid, polymer with 2,4-diisocyanato-1-methylbenzene, hexanedioic acid, alpha-hydro-omega-hydroxypoly[oxy(methyl-1,2- ethanediyl)], 1,1′-methylenebis[4-isocyanatobenzene], 2,2′-oxybis[ethanol], 1,1′-oxybis[2-propanol] and 1,2-propanediol. (generic name) | |
| P-18-0073 | Sulfuric acid, ammonium salt (1:?) | |
| P-18-0048 | Acetic acid, 2-(2-butoxyethoxy)- (CASRN: 82941-26-2) | |
| P-17-0284 | 2-Heptanone, 4-hydroxy- (CASRN: 25290-14-6) | |
| P-17-0285 | 4-Hepten-2-one (CASRN: 24332-22-7) | |
| P-19-0037 | D-Glucaric acid, mixed alkali metal salt (generic name) | |
| P-16-0602 | Carbonic acid, dialkyl ester, polymers with 5-amino-1,3,3-trimethylcycloalkanemethanamine, 2-ethyl-1-alcohol-blocked 1,6-diisocyanatoalkane homopolymer and 1,6-alkanediol and trimethylolakane (generic name) | |
| P-16-0446 | Fatty acids, reaction products with alkylamine, polymers with substituted carbomonocycle, substituted alkylamines, heteromonocycle and substituted alkanoate, lactates (salts) (generic name) | |
| P-19-0003 | Polyaromatic ether symmetrical dicarboxylic anhydride (generic name) | |
| P-18-0174 | Enzyme (generic name) | |
| P-19-0027 | Substituted carbomoncycle, polymer with haloalkyl substituted heteromonocycle,dialkyl-alkanediamine and hydro-hydroxypoly[oxy(alkylalkanediyl)], reaction products with metal oxide and dialkanolamine, acetates (salts) (generic name) | |
**Authority:**
15 U.S.C. 2601 *et seq.*
Dated: July 3, 2019.
Leo Schweer,
Chief, New Chemicals Management Branch, Chemical Control Division, Office of Pollution Prevention and Toxics.