Document ID: EPA-HQ-OPPT-2018-0097-0006
Agency: epa
Document Type: Notice
Title: Certain New Chemicals or Significant New Uses: Statements of Findings for November and December 2018
Posted Date: 2019-06-10T04:00Z

[Federal Register Volume 84, Number 111 (Monday, June 10, 2019)]
[Notices]
[Pages 26866-26868]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-12080]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2018-0097; FRL-9991-65]

Certain New Chemicals or Significant New Uses; Statements of 
Findings for November and December 2018

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 November 1, 2018 to December 31, 2018.

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: 
schweer.greg@epa.gov.
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: TSCA-Hotline@epa.gov.

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 November 1, 2018 to December 31, 2018.

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

[[Page 26867]]

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-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.
P-16-0400.................  Alkanes, C11-16-       https://www.epa.gov/
                             branched and linear    reviewing-new-
                             (CASRN: 1809170-78-    chemicals-under-
                             2).                    toxic-substances-
                                                    control-act-tsca/
                                                    tsca-section-5a3c-
                                                    determination-145.
J-18-0045.................  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-143.
J-18-0046-0047............  Genetically modified   https://www.epa.gov/
                             microorganism          reviewing-new-
                             (generic name).        chemicals-under-
                                                    toxic-substances-
                                                    control-act-tsca/
                                                    tsca-section-5a3c-
                                                    determination-142.
J-19-0002-0004............  Genetically modified   https://www.epa.gov/
                             microorganism          reviewing-new-
                             (generic name).        chemicals-under-
                                                    toxic-substances-
                                                    control-act-tsca/
                                                    tsca-section-5a3c-
                                                    determination-141.
P-18-0221.................  Polyglycerol reaction  https://www.epa.gov/
                             product with acid      reviewing-new-
                             anhydride,             chemicals-under-
                             etherified (generic    toxic-substances-
                             name).                 control-act-tsca/
                                                    tsca-section-5a3c-
                                                    determination-139.
P-18-0324.................  Organic acid dimethyl  https://www.epa.gov/
                             ester, polymer with    reviewing-new-
                             mixed alkanediols      chemicals-under-
                             and 5-isocyanato-1-    toxic-substances-
                             (isocyanatomethyl)-    control-act-tsca/
                             1,3,3-                 tsca-section-5a3c-
                             trimethylcyclohexane   determination-138.
                             ,
                             trimethoxysilylalkyl
                             alkanamine-blocked
                             (generic name).
P-19-0006.................  Diisocyanate polymer   https://www.epa.gov/
                             blocked with           reviewing-new-
                             alkoxyamine (generic   chemicals-under-
                             name).                 toxic-substances-
                                                    control-act-tsca/
                                                    tsca-section-5a3c-
                                                    determination-137.
P-17-0281.................  Polysiloxane-          https://www.epa.gov/
                             polyester polyol       reviewing-new-
                             carboxylate (generic   chemicals-under-
                             name).                 toxic-substances-
                                                    control-act-tsca/
                                                    tsca-section-5a3c-
                                                    determination-136.
P-18-0007-0008............  (P-18-0007)            https://www.epa.gov/
                             Glycerides, soya       reviewing-new-
                             mono- and di-,         chemicals-under-
                             epoxidized, acetates   toxic-substances-
                             (CASRN: 2097734-14-    control-act-tsca/
                             8), (P-18-0008)        tsca-section-5a3c-
                             Glycerides, C16-18     determination-135.
                             and C18-unsatd. mono-
                              and di-,
                             epoxidized, acetates
                             (CASRN: 2097734-15-
                             9).
P-18-0212.................  Substituted            https://www.epa.gov/
                             carbomonocycle,        reviewing-new-
                             polymer with alkyl     chemicals-under-
                             alkenoate, alkenyl     toxic-substances-
                             substituted            control-act-tsca/
                             carbomonocycle,        tsca-section-5a3c-
                             substituted            determination-134.
                             alkanediol,
                             heteropolycycle,
                             alkylene glycol and
                             alkenoic acid,
                             compd. with
                             alkylamino alkanol;
                             polymer exemption
                             flag (generic name).
SN-15-0009................  Fatty acid amide       https://www.epa.gov/
                             (generic name).        reviewing-new-
                                                    chemicals-under-
                                                    toxic-substances-
                                                    control-act-tsca/
                                                    tsca-section-5a3-
                                                    determination.
P-18-0219.................  Polythioether, short   https://www.epa.gov/
                             chain diol polymer     reviewing-new-
                             terminated with        chemicals-under-
                             aliphatic              toxic-substances-
                             diisocyanate           control-act-tsca/
                             (generic name).        tsca-section-5a3c-
                                                    determination-133.
P-18-0068.................  Metal, oxo             https://www.epa.gov/
                             alkylcarboxylate       reviewing-new-
                             complexes (generic     chemicals-under-
                             name).                 toxic-substances-
                                                    control-act-tsca/
                                                    tsca-section-5a3c-
                                                    determination-132.
J-18-0042-0043............  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-131.
P-18-0319.................  Plant oil fatty        https://www.epa.gov/
                             acids, alkyl esters    reviewing-new-
                             (generic name).        chemicals-under-
                                                    toxic-substances-
                                                    control-act-tsca/
                                                    tsca-section-5a3c-
                                                    determination-129.
P-18-0152.................  Hydrolyzed             https://www.epa.gov/
                             functionalized di-     reviewing-new-
                             amino silanol          chemicals-under-
                             polymer (generic       toxic-substances-
                             name).                 control-act-tsca/
                                                    tsca-section-5a3c-
                                                    determination-128.
P-18-0147.................  Phenol, 4-ethenyl-, 1- https://www.epa.gov/
                             substituted, polymer   reviewing-new-
                             with 1-(1,1-           chemicals-under-
                             substituted)-4-        toxic-substances-
                             ethenylbenzene and     control-act-tsca/
                             ethenylbenzene, 2,     tsca-section-5a3c-
                             2'-(1,2-               determination-126.
                             diazenediyl)bis[2-
                             substituted]-
                             initiated,
                             hydrolyzed (generic
                             name).

[[Page 26868]]

 
P-18-0279.................  Substituted            https://www.epa.gov/
                             heteromonocycle,       reviewing-new-
                             polymer with           chemicals-under-
                             substituted            toxic-substances-
                             alkanediol and         control-act-tsca/
                             diisocyanate           tsca-section-5a3c-
                             substituted            determination-127.
                             carbomonocyle,
                             alkylene glycol
                             acrylate-blocked
                             (generic name).
P-18-0136.................  1-Butanaminium, N,N,N- https://www.epa.gov/
                             tributyl-, 2(or5)-     reviewing-new-
                             [[benzoyldihydrodiox   chemicals-under-
                             o[(sulfophenyl)amino   toxic-substances-
                             ]heteropolycycle]oxy   control-act-tsca/
                             ]-5(or 2)-(1,1-        tsca-section-5a3c-
                             dimethylpropyl)benze   determination-125.
                             nesulfonate (2:1)
                             (generic name).
P-17-0382.................  Amides, tallow, N,N-   https://www.epa.gov/
                             bis(2-hydroxypropyl)   reviewing-new-
                             (CASRN 1454803-04-3).  chemicals-under-
                                                    toxic-substances-
                                                    control-act-tsca/
                                                    tsca-section-5a3c-
                                                    determination-124.
P-18-0054.................  2-Alkenoic acid, 2-    https://www.epa.gov/
                             alkyl-, 2-alkyl        reviewing-new-
                             ester, polymer with    chemicals-under-
                             alkyl 2-alkenoate, 2-  toxic-substances-
                             substitutedalkyl 2-    control-act-tsca/
                             alkenoate and 2-       tsca-section-5a3c-
                             substitutedalkyl 2-    determination-123.
                             alkyl-2-alkenoate,
                             esters with
                             carboxylic acids,
                             tert alkylperoxoate
                             initiated; polymer
                             exemption flag
                             (generic name).
P-18-0078.................  2-Alkenoic acid, 2-    https://www.epa.gov/
                             alkyl-, 2-alkyl        reviewing-new-
                             ester, polymer with    chemicals-under-
                             alkyl 2-alkenoate, 2-  toxic-substances-
                             substitutedalkyl 2-    control-act-tsca/
                             alkenoate and 2-       tsca-section-5a3c-
                             substitutedalkyl 2-    determination-122.
                             alkyl-2-alkenoate,
                             tert alkylperoxoate
                             initiated; polymer
                             exemption flag
                             (generic name).
P-18-0261.................  Metal,                 https://www.epa.gov/
                             alkylcarboxylate oxo   reviewing-new-
                             complexes (generic     chemicals-under-
                             name).                 toxic-substances-
                                                    control-act-tsca/
                                                    tsca-section-5a3c-
                                                    determination-121.
J-18-0044.................  Saccharomyces          https://www.epa.gov/
                             cerevisiae NE095.      reviewing-new-
                                                    chemicals-under-
                                                    toxic-substances-
                                                    control-act-tsca/
                                                    tsca-section-5a3c-
                                                    determination-120.
J-18-0041.................  E. coli K-12 C003,     https://www.epa.gov/
                             arsenic detecting      reviewing-new-
                             strain of E. coli      chemicals-under-
                             with extra-            toxic-substances-
                             chromosomal            control-act-tsca/
                             elements, including    tsca-section-5a3c-
                             an intergeneric        determination-119.
                             screening marker
                             (generic name).
P-18-0233.................  Alkyl alkenoic acid,   https://www.epa.gov/
                             alkyl ester, telomer   reviewing-new-
                             with alkylthiol,       chemicals-under-
                             substituted            toxic-substances-
                             carbomonocycle,        control-act-tsca/
                             substituted alkyl      tsca-section-5a3c-
                             alkyl alkenoate and    determination-118.
                             hydroxyalkyl
                             alkenoate, tert-
                             butyl alkyl
                             peroxoate-initiated
                             (generic name).
------------------------------------------------------------------------

    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. 2019-12080 Filed 6-7-19; 8:45 am]
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