[Federal Register Volume 84, Number 136 (Tuesday, July 16, 2019)]
[Notices]
[Pages 33935-33937]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-15004]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2019-0271; FRL-9995-62]


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

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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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:

[[Page 33936]]

     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
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P-19-0020................  Alkylphenol, reaction   https://www.epa.gov/
                            products with carbon    reviewing-new-
                            dioxide, distn.         chemicals-under-
                            residues from manuf.    toxic-substances-
                            of alkylphenol          control-act-tsca/
                            derivs. and calcium     tsca-section-5a3c-
                            alkylphenol derivs.     determination-227.
                            (generic name).
P-18-0247-0252...........  (P-18-0247) Isocyanic   https://www.epa.gov/
                            acid,                   reviewing-new-
                            polymethylenepolyphen   chemicals-under-
                            ylene ester, polymer    toxic-substances-
                            with 2-ethyl-2-         control-act-tsca/
                            (hydroxymethyl)-1,3-    tsca-section-5a3c-
                            propanediol,            determination-222.
                            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,
                            polymethylenepolyphen
                            ylene ester, polymer
                            with polyetherpolyol,
                            2-butoxyethanol- and
                            2-(2-
                            butoxyethoxy)ethanol-
                            and methanol blocked
                            (generic name), (P-18-
                            249) Isocyanic acid,
                            polymethylenepolyphen
                            ylene 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,
                            polymethylenepolyphen
                            ylene ester, polymer
                            with polyetherpolyol,
                            2-butoxyethanol- and
                            2-(2-
                            butoxyethoxy)ethanol-
                            and 1(or2)-(2-
                            methoxymethylethoxy)p
                            ropanol-blocked
                            (generic name), (P-18-
                            0251) Isocyanic acid,
                            polymethylenepolyphen
                            ylene ester, 2-
                            butoxyethanol- and 2-
                            (2-
                            butoxyethoxy)ethanol-
                            and methanol- and
                            1(or2)-(2-
                            methoxymethylethoxy)p
                            ropanol-blocked
                            (specific name), (P-
                            18-0252) Isocyanic
                            acid,
                            polymethylenepolyphen
                            ylene ester, 2-
                            butoxyethanol- and 2-
                            (2-
                            butoxyethoxy)ethanol-
                            and methanol- and 1-
                            methoxy-2-propanol-
                            blocked (specific
                            name).
P-17-0253................  Oxirane, 2-methyl-,     https://www.epa.gov/
                            polymer with oxirane,   reviewing-new-
                            methyl 2-(substituted   chemicals-under-
                            carbomonocycle          toxic-substances-
                            isoquinolin-2(3H)-yl)   control-act-tsca/
                            propyl ether (generic   tsca-section-5a3c-
                            name).                  determination-218.
P-17-0245................  Unsaturated polyfluoro  https://www.epa.gov/
                            ester (generic name).   reviewing-new-
                                                    chemicals-under-
                                                    toxic-substances-
                                                    control-act-tsca/
                                                    tsca-section-5a3c-
                                                    determination-208.
P-17-0152................  Poly-(2-methyl-1-oxo-2- https://www.epa.gov/
                            propen-1-yl) ester      reviewing-new-
                            with Ethanaminium,      chemicals-under-
                            N,N,N-trialkyl,         toxic-substances-
                            chloride and            control-act-tsca/
                            methoxypoly(oxy-1,2-    tsca-section-5a3c-
                            ethanediyl) (generic    determination-207.
                            name).
P-16-0422................  1,2-                    https://www.epa.gov/
                            Cyclohexanedicarboxyl   reviewing-new-
                            ic acid, 1-             chemicals-under-
                            (phenylmethyl) ester,   toxic-substances-
                            ester with 2,2,4-       control-act-tsca/
                            trimethyl-1,3-          tsca-section-5a3c-
                            pentanediol mono(2-     determination-206.
                            methylpropanoate)
                            (CASRN: 1661012-65-2).
P-14-0482................  Organic salt (generic   https://www.epa.gov/
                            name).                  reviewing-new-
                                                    chemicals-under-
                                                    toxic-substances-
                                                    control-act-tsca/
                                                    tsca-section-5a3c-
                                                    determination-205.
P-19-0046................  1,2,4-                  https://www.epa.gov/
                            Benzenetricarboxylic    reviewing-new-
                            acid, mixed decyl and   chemicals-under-
                            octyl triesters         toxic-substances-
                            (CASRN: 90218-76-1).    control-act-tsca/
                                                    tsca-section-5a3c-
                                                    determination-204.

[[Page 33937]]

 
P-18-0266................  Alkanes, C20-45         https://www.epa.gov/
                            branched and linear     reviewing-new-
                            (CASRN: 2133415-24-2).  chemicals-under-
                                                    toxic-substances-
                                                    control-act-tsca/
                                                    tsca-section-5a3c-
                                                    determination-203.
P-18-0305................  Alkenoic acid, alkyl-   https://www.epa.gov/
                            ,alkyl ester, polymer   reviewing-new-
                            with alkyl alkenoate,   chemicals-under-
                            substituted             toxic-substances-
                            heteromonocycycle,      control-act-tsca/
                            substituted             tsca-section-5a3c-
                            carbomonocycle,         determination-200.
                            substituted
                            alkanediol and
                            alkenoic acid, alkali
                            metal salt (generic
                            name).
P-18-0186................  Polyolefin ester        https://www.epa.gov/
                            (generic name).         reviewing-new-
                                                    chemicals-under-
                                                    toxic-substances-
                                                    control-act-tsca/
                                                    tsca-section-5a3c-
                                                    determination-199.
J-19-0012-0015...........  Biofuel producing       https://www.epa.gov/
                            Saccharomyces           reviewing-new-
                            cerevisiae modified,    chemicals-under-
                            genetically stable      toxic-substances-
                            (generic name).         control-act-tsca/
                                                    tsca-section-5a3c-
                                                    determination-198.
J-19-0017................  Genetically modified    https://www.epa.gov/
                            microorganism for the   reviewing-new-
                            production of a         chemicals-under-
                            chemical substance      toxic-substances-
                            (generic name).         control-act-tsca/
                                                    tsca-section-5a3c-
                                                    determination-197.
J-19-0011................  Genetically modified    https://www.epa.gov/
                            microorganism for the   reviewing-new-
                            production of a         chemicals-under-
                            chemical substance      toxic-substances-
                            (generic name).         control-act-tsca/
                                                    tsca-section-5a3c-
                                                    determination-196.
P-19-0045................  Non-metal tetrakis      https://www.epa.gov/
                            (hydroxyalkyl)-,        reviewing-new-
                            halide, polymer with    chemicals-under-
                            amide oxidized          toxic-substances-
                            (generic name).         control-act-tsca/
                                                    tsca-section-5a3c-
                                                    determination-195.
P-19-0032................  Carbonic dichloride,    https://www.epa.gov/
                            polymer with 4,4'-(1-   reviewing-new-
                            methylethylidene)bis[   chemicals-under-
                            phenol] ester,          toxic-substances-
                            polymer with tetrol     control-act-tsca/
                            and polyether tetrol    tsca-section-5a3c-
                            (generic name).         determination-194.
P-19-0030................  Triethanolamine         https://www.epa.gov/
                            modified                reviewing-new-
                            Phosphinicocarboxylat   chemicals-under-
                            es, sodium salts        toxic-substances-
                            (generic name).         control-act-tsca/
                                                    tsca-section-5a3c-
                                                    determination-193.
P-18-0375................  Fats and Glyceridic     https://www.epa.gov/
                            oils, vegetable,        reviewing-new-
                            sulfonated, sodium      chemicals-under-
                            salts (CASRN: 97489-    toxic-substances-
                            04-8).                  control-act-tsca/
                                                    tsca-section-5a3c-
                                                    determination-192.
P-18-0312................  Formaldehyde, polymer   https://www.epa.gov/
                            with 2-phenoxyalkanol   reviewing-new-
                            and .alpha.-phenyl-     chemicals-under-
                            .omega.                 toxic-substances-
                            hydroxypoly(oxy-1,2-    control-act-tsca/
                            alkylnediyl),           tsca-section-5a3c-
                            dihydrogen phosphate    determination-191.
                            2-phenoxyalkyl
                            hydrogen phosphate,
                            alkaline salt
                            (generic name).
P-18-0122................  Alkylamide, polymer     https://www.epa.gov/
                            with alkylamine,        reviewing-new-
                            formaldehyde, and       chemicals-under-
                            polycyanamide, alkyl    toxic-substances-
                            acid salt (generic      control-act-tsca/
                            name).                  tsca-section-5a3c-
                                                    determination-190.
P-19-0040................  Alkyl bis(dialkylamino  https://www.epa.gov/
                            alkyl) amide (generic   reviewing-new-
                            name).                  chemicals-under-
                                                    toxic-substances-
                                                    control-act-tsca/
                                                    tsca-section-5a3c-
                                                    determination-189.
P-19-0010................  Hydrogenated fatty      https://www.epa.gov/
                            acid dimers, polymers   reviewing-new-
                            with 1,1'-              chemicals-under-
                            methylenebis[4-         toxic-substances-
                            isocyanatobenzene],     control-act-tsca/
                            polypropylene glycol,   tsca-section-5a3c-
                            polypropylene glycol    determination-188.
                            ether with
                            trimethylolpropane
                            (3:1), and 1,3-
                            propanediol,
                            propylene glycol
                            monomethacrylate-
                            blocked (generic
                            name).
P-18-0222................  Silane, alkenylalkoxy-  https://www.epa.gov/
                            , polymer with alkene   reviewing-new-
                            and alkene (generic     chemicals-under-
                            name).                  toxic-substances-
                                                    control-act-tsca/
                                                    tsca-section-5a3c-
                                                    determination-187.
P-18-0162................  Cashew nutshell         https://www.epa.gov/
                            liquid, polymer with    reviewing-new-
                            diisocyanatoalkane,     chemicals-under-
                            substituted-            toxic-substances-
                            polyoxyalkyldiol and    control-act-tsca/
                            polyether polyol        tsca-section-5a3c-
                            (generic name).         determination-186.
P-17-0239................  Substituted carboxylic  https://www.epa.gov/
                            acid, polymer with      reviewing-new-
                            2,4-diisocyanato-1-     chemicals-under-
                            methylbenzene,          toxic-substances-
                            hexanedioic acid,       control-act-tsca/
                            alpha-hydro-omega-      tsca-section-5a3c-
                            hydroxypoly[oxy(methy   determination-185.
                            l-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,          https://www.epa.gov/
                            ammonium salt (1:?).    reviewing-new-
                                                    chemicals-under-
                                                    toxic-substances-
                                                    control-act-tsca/
                                                    tsca-section-5a3c-
                                                    determination-184.
P-18-0048................  Acetic acid, 2-(2-      https://www.epa.gov/
                            butoxyethoxy)-          reviewing-new-
                            (CASRN: 82941-26-2).    chemicals-under-
                                                    toxic-substances-
                                                    control-act-tsca/
                                                    tsca-section-5a3c-
                                                    determination-183.
P-17-0284................  2-Heptanone, 4-hydroxy- https://www.epa.gov/
                             (CASRN: 25290-14-6).   reviewing-new-
                                                    chemicals-under-
                                                    toxic-substances-
                                                    control-act-tsca/
                                                    tsca-section-5a3c-
                                                    determination-182.
P-17-0285................  4-Hepten-2-one (CASRN:  https://www.epa.gov/
                            24332-22-7).            reviewing-new-
                                                    chemicals-under-
                                                    toxic-substances-
                                                    control-act-tsca/
                                                    tsca-section-5a3c-
                                                    determination-181.
P-19-0037................  D-Glucaric acid, mixed  https://www.epa.gov/
                            alkali metal salt       reviewing-new-
                            (generic name).         chemicals-under-
                                                    toxic-substances-
                                                    control-act-tsca/
                                                    tsca-section-5a3c-
                                                    determination-179.
P-16-0602................  Carbonic acid, dialkyl  https://www.epa.gov/
                            ester, polymers with    reviewing-new-
                            5-amino-1,3,3-          chemicals-under-
                            trimethylcycloalkanem   toxic-substances-
                            ethanamine, 2-ethyl-1-  control-act-tsca/
                            alcohol-blocked 1,6-    tsca-section-5a3c-
                            diisocyanatoalkane      determination-178.
                            homopolymer and 1,6-
                            alkanediol and
                            trimethylolakane
                            (generic name).
P-16-0446................  Fatty acids, reaction   https://www.epa.gov/
                            products with           reviewing-new-
                            alkylamine, polymers    chemicals-under-
                            with substituted        toxic-substances-
                            carbomonocycle,         control-act-tsca/
                            substituted             tsca-section-5a3c-
                            alkylamines,            determination-177.
                            heteromonocycle and
                            substituted
                            alkanoate, lactates
                            (salts) (generic
                            name).
P-19-0003................  Polyaromatic ether      https://www.epa.gov/
                            symmetrical             reviewing-new-
                            dicarboxylic            chemicals-under-
                            anhydride (generic      toxic-substances-
                            name).                  control-act-tsca/
                                                    tsca-section-5a3c-
                                                    determination-176.
P-18-0174................  Enzyme (generic name).  https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/tsca-section-5a3c-determination-175.
P-19-0027................  Substituted             https://www.epa.gov/
                            carbomoncycle,          reviewing-new-
                            polymer with            chemicals-under-
                            haloalkyl substituted   toxic-substances-
                            heteromonocycle,dialk   control-act-tsca/
                            yl-alkanediamine and    tsca-section-5a3c-
                            hydro-                  determination-171.
                            hydroxypoly[oxy(alkyl
                            alkanediyl)],
                            reaction products
                            with metal oxide and
                            dialkanolamine,
                            acetates (salts)
                            (generic name).
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    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.
[FR Doc. 2019-15004 Filed 7-15-19; 8:45 am]
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