[Federal Register Volume 86, Number 24 (Monday, February 8, 2021)]
[Notices]
[Pages 8628-8631]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-02523]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2019-0271; FRL-10000-99]


Certain New Chemicals or Significant New Uses; Statements of 
Findings for August 2019

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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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 August 1, 2019 to August 31, 2019.

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: 
[email protected].
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-

[[Page 8629]]

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-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       https://www.epa.gov/
                                      substituted alkylene bis heteromonocycle,        reviewing-new-chemicals-
                                      substituted carbomonocycle and (alkylalkenyl)    under-toxic-substances-
                                      carbomonocycle, alkali metal salt (generic       control-act-tsca/tsca-
                                      name).                                           section-5a3c-
                                                                                       determination-293.
P-19-0118..........................  Substituted polyalkylenepoly, reaction products  https://www.epa.gov/
                                      with alkene polymer (generic name).              reviewing-new-chemicals-
                                                                                       under-toxic-substances-
                                                                                       control-act-tsca/tsca-
                                                                                       section-5a3c-
                                                                                       determination-292.
P-19-0099..........................  Propanoic acid, 3-hydroxy-2-(hydroxymethyl)-2-   https://www.epa.gov/
                                      methyl-, polymer with dimethyl carbonate, 1,2-   reviewing-new-chemicals-
                                      ethanediamine, 2-ethyl-2-(hydroxymethyl)-1,3-    under-toxic-substances-
                                      propanediol, 1,6-hexanediol and 1,1'-            control-act-tsca/tsca-
                                      methylenebis[4-isocyanatocyclohexane], compd.    section-5a3c-
                                      with N,N-diethylethanamine (CASRN: 1178511-46-   determination-291.
                                      0).

[[Page 8630]]

 
P-19-0047..........................  Propanoic acid, 3-hydroxy-2-(hydroxymethyl)-2-   https://www.epa.gov/
                                      methyl-, polymer with 5-amino-1,3,3-             reviewing-new-chemicals-
                                      trimethylcyclohexanemethanamine, .alpha.-hydro-  under-toxic-substances-
                                      .omega.-hydroxypoly(oxy-1,4-butanediyl),         control-act-tsca/tsca-
                                      alpha.-hydro-.omega.-hydroxypoly[oxy(methyl-     section-5a3c-
                                      1,2-ethanediyl)], 5-isocyanato-1-                determination-290.
                                      (isocyanatomethyl)-1,3,3-trimethylcyclohexane
                                      and 1,1'-methylenebis[4-isocyanatobenzene], Pr
                                      alc.-blocked (CASRN: 2283318-90-9).
P-19-0024..........................  Silsesquioxanes, 3-                              https://www.epa.gov/
                                      (dimethyloctadecylammonio)propyl Me Pr,          reviewing-new-chemicals-
                                      polymers with silicic acid (H4Si04) tetra-Et     under-toxic-substances-
                                      ester, (2-hydroxyethoxy)- and                    control-act-tsca/tsca-
                                      methoxyterminated, chlorides (CASRN: 2231249-    section-5a3c-
                                      14-0).                                           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-       https://www.epa.gov/
                                      methyl- (CASRN: 568591-00-4).                    reviewing-new-chemicals-
                                                                                       under-toxic-substances-
                                                                                       control-act-tsca/tsca-
                                                                                       section-5a3c-
                                                                                       determination-287.
P-18-0276..........................  Benzenesulfonamide, N-[2-                        https://www.epa.gov/
                                      [[(phenylamino)carbonyl]amino]phenyl]- (CASRN:   reviewing-new-chemicals-
                                      215917-77-4).                                    under-toxic-substances-
                                                                                       control-act-tsca/tsca-
                                                                                       section-5a3c-
                                                                                       determination-286.
P-18-0197..........................  Metal, alkylcarboxylate oxo complexes (generic   https://www.epa.gov/
                                      name).                                           reviewing-new-chemicals-
                                                                                       under-toxic-substances-
                                                                                       control-act-tsca/tsca-
                                                                                       section-5a3c-
                                                                                       determination-285.
P-18-0172..........................  Calcium, carbonate 2-ethylhexanoate              https://www.epa.gov/
                                      neodecanoate propionate complex (specific        reviewing-new-chemicals-
                                      name).                                           under-toxic-substances-
                                                                                       control-act-tsca/tsca-
                                                                                       section-5a3c-
                                                                                       determination-284.
P-18-0109..........................  2-Alkenoic acid, 2-alkyl-, alkyl ester, polymer  https://www.epa.gov/
                                      with 2-(dialkylamino)alkyl 2-alkyl-2-            reviewing-new-chemicals-
                                      alkenoate, alkyl 2-alkyl-2-alkenoate and a-(2-   under-toxic-substances-
                                      alkyl-1-oxo-2-alken-1-yl)-o-alkoxypoly(oxy-1,2-  control-act-tsca/tsca-
                                      alkanediyl), [(1-alkoxy-2-alkyl-1-alken-1-       section-5a3c-
                                      yl)oxy]trialkylsilane-initiated (generic name).  determination-283.
P-17-0347, P-17-0348, P-17-0349, P-  (P-17-0347) Oxirane, 2-methyl-, polymer with     https://www.epa.gov/
 17-0350, P-17-0351, P-17-0352.       oxirane, mono(2-butyloctyl) ether                reviewing-new-chemicals-
                                      (CASRN:252756-20-0), (P-17-0348) oxirane, 2-     under-toxic-substances-
                                      methyl-, polymer with oxirane, mono(2-           control-act-tsca/tsca-
                                      hexyldecyl) ether (CASRN: 125005-52-9), (P-17-   section-5a3c-
                                      0349) oxirane, 2-methyl-, polymer with           determination-294.
                                      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).
P-16-0541..........................  Specific: Soybean meal, reaction products with   https://www.epa.gov/
                                      phosphoric trichloride (CASRN: 1962913-92-3).    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      https://www.epa.gov/
                                      alkanediyl bis[alkyl-tris(alkyl-heterocycle)-    reviewing-new-chemicals-
                                      1,3,5-triazine-2,4,6-triamine and hydrogen       under-toxic-substances-
                                      peroxide, (P-18-0388) 1,3,5-triazine-2,4,6-      control-act-tsca/tsca-
                                      triamine, alkanediyl bis[alkyl-tris(alkyl-       section-5a3c-
                                      heterocycle)-, allyl derivs., oxidized,          determination-281.
                                      hydrogenated (generic names).
P-17-0299..........................  2-Propenoic acid, alkyl-, polymers with alkyl    https://www.epa.gov/
                                      acrylate and polyethylene glycol methacrylate    reviewing-new-chemicals-
                                      alkyl ether (generic name).                      under-toxic-substances-
                                                                                       control-act-tsca/tsca-
                                                                                       section-5a3c-
                                                                                       determination-280.
P-18-0155, P-18-0156...............  (P-18-0155) Crosslinked polymer of alkyl         https://www.epa.gov/
                                      acrylamides, acrylate esters, and alkyl          reviewing-new-chemicals-
                                      acrylamide sulfonate salt, (P-18-0156)           under-toxic-substances-
                                      Crosslinked polymer of alkyl acrylamides,        control-act-tsca/tsca-
                                      acrylate esters, and alkyl acrylamide sulfonic   section-5a3c-
                                      acid (generic names).                            determination-279.
SN-19-0005.........................  Functionalized multi-walled carbon nanotubes     https://www.epa.gov/
                                      (generic name).                                  reviewing-new-chemicals-
                                                                                       under-toxic-substances-
                                                                                       control-act-tsca/tsca-
                                                                                       section-5a3c-
                                                                                       determination-278.
P-19-0085..........................  Aliphatic hydrocarbons, C16-18-branched and      https://www.epa.gov/
                                      linear (generic name).                           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         https://www.epa.gov/
                                      ethenylbenzene, 4-hydroxy-substituted butyl      reviewing-new-chemicals-
                                      amide, polymers with epichlorohydrin and         under-toxic-substances-
                                      trimethylolpropane, sodium salts, (P-18-0191)    control-act-tsca/tsca-
                                      2,5-Furandione, polymer with ethenylbenzene, 4-  section-5a3c-
                                      hydroxy-substituted butyl [3-[2-[1-              determination-276.
                                      [[(substituted phenyl)amino]carbonyl]-2-
                                      oxopropyl]diazenyl]phenyl]methyl amide,
                                      polymers with epichlorohydrin and
                                      trimthylolpropane, sodium salts (generic
                                      names).
----------------------------------------------------------------------------------------------------------------



[[Page 8631]]

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

    Dated: October 30, 2020.
Madison Le,
Director, New Chemicals Division, Office of Pollution Prevention and 
Toxics.
[FR Doc. 2021-02523 Filed 2-5-21; 8:45 am]
BILLING CODE 6560-50-P