[Federal Register Volume 84, Number 111 (Monday, June 10, 2019)] [Notices] [Pages 26871-26873] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 2019-12083] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OPPT-2019-0271; FRL-9994-26] Certain New Chemicals or Significant New Uses; Statements of Findings for January-March 2019 AGENCY: Environmental Protection Agency (EPA). ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: 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 January 1, 2019 to March 31, 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 January 1, 2019 to March 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 link to EPA's decision document describing the basis of the [[Page 26872]] ``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-19-0035................. Acetamide, 2-(4- https://www.epa.gov/ methylphenoxy)-N-1H- reviewing-new- pyrazol-3-yl-N-(2- chemicals-under- thienylmethyl)- toxic-substances- (CASRN: 1374760-95- control-act-tsca/ 8). tsca-section-5a3c- determination-180. P-18-0229................. Modified branched https://www.epa.gov/ alkenyl acid, alkyl reviewing-new- ester, homopolymer chemicals-under- (generic name). toxic-substances- control-act-tsca/ tsca-section-5a3c- determination-174. P-18-0179-0181............ (P-18-0179) Phenol, https://www.epa.gov/ polymer with reviewing-new- formaldehyde and chemicals-under- phenolic resin, toxic-substances- sodium salt, (P-18- control-act-tsca/ 0180) Phenol, tsca-section-5a3c- polymer with determination-173. formaldehyde and phenolic resin, potassium salt, (P- 18-0181) Phenol, polymer with formaldehyde and phenolic resin, potassium sodium salt (generic names). P-17-0191................. Alkyldiamine, https://www.epa.gov/ aminoalkyl reviewing-new- dimethylaminoalkyl chemicals-under- dimethyl-, reaction toxic-substances- products with control-act-tsca/ propylene oxide tsca-section-5a3c- (generic name). determination-172. P-18-0085................. Fatty acids reaction https://www.epa.gov/ products with reviewing-new- ethyleneamines and chemicals-under- dialkyl ester toxic-substances- (generic name). control-act-tsca/ tsca-section-5a3c- determination-170. P-18-0101................. Pentaerythritol, https://www.epa.gov/ mixed esters with reviewing-new- linear and branched chemicals-under- fatty acids (generic toxic-substances- name). control-act-tsca/ tsca-section-5a3c- determination-169. P-17-0220................. 2-Oxepanone, reaction https://www.epa.gov/ products with reviewing-new- alkylenediamine- chemicals-under- alkyleneimine toxic-substances- polymer, 2-[[(2- control-act-tsca/ alkyl)oxy]alkyl]oxir tsca-section-5a3c- ane and tetrahydro- determination-168. 2H-pyran-2-one (generic name). P-19-0026................. Alkanoic acid, https://www.epa.gov/ compounds with reviewing-new- substituted chemicals-under- carbomonocycle- toxic-substances- dialkyl- control-act-tsca/ alkanediaminehalosub tsca-section-5a3c- stitued determination-167. heteromonocycle- polyalkylene glycol polymerdialkanolamin e reaction products (generic name). P-18-0307................. Alkyl alkenoic acid, https://www.epa.gov/ alkyl ester, telomer reviewing-new- with alkyl chemicals-under- alkenoate, toxic-substances- substituted alkyl control-act-tsca/ alkyl alkenoate, tsca-section-5a3c- alkylthiol, determination-166. substituted carbomonocycle, hydroxyalkyl alkyl alkenoate and alkyl alkyl alkenoate (generic name). P-19-0009................. Carbonmonocycles, https://www.epa.gov/ polymer with reviewing-new- haloalkyl chemicals-under- substituted toxic-substances- heteromonocycle and control-act-tsca/ hydro- tsca-section-5a3c- hydroxypoly[oxy(alky determination-165. l-alkanediyl)], dialkyl- alkanediaminetermina ted, hydroxyalkylated, acetates (salts) (generic name). P-18-0284................. Inorganic acid, https://www.epa.gov/ reaction products reviewing-new- with alkyl alcohol chemicals-under- (generic name). toxic-substances- control-act-tsca/ tsca-section-5a3c- determination-164. P-18-0278................. Isophthalic acid, https://www.epa.gov/ polymer with reviewing-new- terephthalic acid chemicals-under- and C4 and C6 toxic-substances- dialkyl amines control-act-tsca/ (generic name). tsca-section-5a3c- determination-163. J-19-0006-0008............ Genetically modified https://www.epa.gov/ microorganism for reviewing-new- the production of a chemicals-under- chemical substance toxic-substances- (generic name). control-act-tsca/ tsca-section-5a3c- determination-162. P-19-0025................. 11-Docosene (CASRN: https://www.epa.gov/ 62978-77-2). reviewing-new- chemicals-under- toxic-substances- control-act-tsca/ tsca-section-5a3c- determination-161. P-19-0021-0022............ (P-19-0021) https://www.epa.gov/ Hydroxyalkyl reviewing-new- carboxylic acid, chemicals-under- polymer with toxic-substances- alkylamine, alkylene control-act-tsca/ carbonate, tsca-section-5a3c- alkanediol, determination-160. isocyanate, compd. with alkylamine, (P- 19-0022) Hydroxyalkyl carboxylic acid, polymer with alkylamine, alkyl carbonate, alkanediol, isocyanate, compd. with alkylamine (generic names). P-19-0002................. Polyaromatic https://www.epa.gov/ symmetrical reviewing-new- tetracarboxylic acid chemicals-under- (generic name). toxic-substances- control-act-tsca/ tsca-section-5a3c- determination-159. P-18-0272................. Metal, https://www.epa.gov/ alkylcarboxylate oxo reviewing-new- complexes (generic chemicals-under- name). toxic-substances- control-act-tsca/ tsca-section-5a3c- determination-158. P-18-0169................. Propanoic acid, 3- https://www.epa.gov/ hydroxy-2- reviewing-new- (hydroxymethyl)-2- chemicals-under- methyl-, polymer toxic-substances- with dimethyl control-act-tsca/ carbonate, 1,6- tsca-section-5a3c- hexanediol, diamine determination-157. and 1,1'- methylenebis[4- isocyanatocyclohexan e], acrylate- blocked, compds. with triethylamine (generic name). P-17-0119................. Alkyl alkenoic acid, https://www.epa.gov/ alkoxyalkyl ester, reviewing-new- polymer with alkyl chemicals-under- alkenoate, alkyl toxic-substances- alkyl alkenoate and control-act-tsca/ tris alkyl silyl tsca-section-5a3c- alkyl alkenaote determination-156. (generic name). P-18-0077................. Urea, reaction https://www.epa.gov/ products with N- reviewing-new- butylphosphorothioic chemicals-under- triamide and toxic-substances- formaldehyde (CASRN: control-act-tsca/ 2093385-47-6). tsca-section-5a3c- determination-155. [[Page 26873]] P-18-0132................. Substituted benzene, https://www.epa.gov/ 4-methoxy-2-nitro-5- reviewing-new- [2-[(1E)-1-[[(2- chemicals-under- methoxyphenyl)amino] toxic-substances- carbonyl]-2- control-act-tsca/ oxopropylidene]hydra tsca-section-5a3c- zinyl]-, sodium salt determination-154. (1:1) (generic name). P-18-0118-0119............ (P-18-0118) Oxirane, https://www.epa.gov/ 2-methyl-, polymer reviewing-new- with methoxirane chemicals-under- homopolymer, 1,1'- toxic-substances- methylenebis[4- control-act-tsca/ isocyanatobenzene], tsca-section-5a3c- and glycerol- determination-153. propylene oxide polymer, (P-18-0119) Oxirane, 2-methyl-, polymer with methoxirane homopolymer, 1,1'- methylenebis[isocyan atobenzene], and glycerol-propylene oxide polymer (generic names). P-18-0107................. Alcohol capped https://www.epa.gov/ polycarbodiimide reviewing-new- from chemicals-under- diethyldiisocyanatob toxic-substances- enzene (generic control-act-tsca/ name). tsca-section-5a3c- determination-152. P-18-0379................. Cashew nutshell https://www.epa.gov/ liquid polymer with reviewing-new- Epichlorohydrin, chemicals-under- formaldehyde, toxic-substances- phenol, amines and control-act-tsca/ glycol (generic tsca-section-5a3c- name). determination-151. P-18-0277................. Poly[2- https://www.epa.gov/ (Dimethylamino)ethyl reviewing-new- acrylate chloride chemicals-under- salt, vinyl acetate, toxic-substances- methacrylic acid and control-act-tsca/ alkyl acrylates] tsca-section-5a3c- (generic name). determination-150. P-19-0007................. Alkenoic acid, alkyl- https://www.epa.gov/ , hydroxyalkyl reviewing-new- ester, polymer with chemicals-under- alkyl-alkenoate, toxic-substances- alkenylcarbomonocycl control-act-tsca/ e, hydroxyalkyl- tsca-section-5a3c- alkenoate, alkyl determination-149. substituted alkenoate and heteromonocycle, alkyl substituted peroxoate-initiated, polymers with [substituted alkanenitrile]- initiated acrylic acid-alkane acrylates-alkyl substituted carbomoncycle polymer; polymer exemption flag (generic name). P-17-0387-0388............ Dicarboxylic acids, https://www.epa.gov/ polymers with reviewing-new- alkanoic acid, chemicals-under- alkanediol, toxic-substances- susbtituted- control-act-tsca/ alkylalkanoic acid, tsca-section-5a3c- substituted alkyl determination-148. carbomonocyle, alkanedioic acid and alkanediol, alkanolamine blocked compds with alkanolamine (generic name). P-19-0008................. Substituted https://www.epa.gov/ polyalkylenepolycarb reviewing-new- omonocycle ester, chemicals-under- polymer with toxic-substances- dialkanolamine, control-act-tsca/ (hydroxyalkoxy)carbo tsca-section-5a3c- nyl] derivs., determination-147. (alkoxyalkoxy) alkanol blocked (generic name). P-18-0238................. Saccharide reaction https://www.epa.gov/ products with acid reviewing-new- anhydride, chemicals-under- etherified (generic toxic-substances- name). control-act-tsca/ tsca-section-5a3c- determination-146. P-18-0020................. Butanedioic acid, https://www.epa.gov/ polymer with 2-ethyl- reviewing-new- 2-(hydroxymethyl)- chemicals-under- 1,3-propanediol, 2,5- toxic-substances- furandione and 1,3- control-act-tsca/ propanediol, tsca-section-5a3c- 3a,4,5,6,7,7a- determination-144. hexahydro-4,7- methano-1H-inden- 5(or 6)-yl ester. ------------------------------------------------------------------------ Authority: 15 U.S.C. 2601 et seq. Dated: June 3, 2019. Leo Schweer, Chief, New Chemicals Management Branch, Chemical Control Division, Office of Pollution Prevention and Toxics. [FR Doc. 2019-12083 Filed 6-7-19; 8:45 am] BILLING CODE 6560-50-P