Certain New Chemicals or Significant New Uses; Statements of Findings for October 2018, 26868-26871 [2019-12081]
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26868
Federal Register / Vol. 84, No. 111 / Monday, June 10, 2019 / Notices
EPA case No.
P–18–0279 ..............
P–18–0136 ..............
P–17–0382 ..............
P–18–0054 ..............
Chemical identity
Substituted heteromonocycle, polymer with substituted
alkanediol and diisocyanate substituted carbomonocyle,
alkylene glycol acrylate-blocked (generic name).
1-Butanaminium, N,N,N-tributyl-, 2(or5)- [[benzoyl
dihydrodioxo[(sulfophenyl)amino]heteropolycycle]oxy]5(or 2)-(1,1- dimethylpropyl)benzenesulfonate (2:1) (generic name).
Amides, tallow, N,N-bis(2-hydroxypropyl) (CASRN
1454803–04–3).
P–18–0261 ..............
2-Alkenoic acid, 2-alkyl-, 2-alkyl ester, polymer with alkyl 2alkenoate, 2-substitutedalkyl 2-alkenoate and 2substitutedalkyl 2-alkyl-2-alkenoate, esters with carboxylic acids, tert alkylperoxoate initiated; polymer exemption flag (generic name).
2-Alkenoic acid, 2-alkyl-, 2-alkyl ester, polymer with alkyl 2alkenoate, 2-substitutedalkyl 2-alkenoate and 2substitutedalkyl 2-alkyl-2-alkenoate, tert alkylperoxoate
initiated; polymer exemption flag (generic name).
Metal, alkylcarboxylate oxo complexes (generic name) .......
J–18–0044 ...............
Saccharomyces cerevisiae NE095 ........................................
J–18–0041 ...............
E. coli K-12 C003, arsenic detecting strain of E. coli with
extra-chromosomal elements, including an intergeneric
screening marker (generic name).
Alkyl alkenoic acid, alkyl ester, telomer with alkylthiol, substituted carbomonocycle, substituted alkyl alkyl alkenoate
and hydroxyalkyl alkenoate, tert-butyl alkyl peroxoate-initiated (generic name).
P–18–0078 ..............
P–18–0233 ..............
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]
ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–OPPT–2018–0097; FRL–9991–67]
Certain New Chemicals or Significant
New Uses; Statements of Findings for
October 2018
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
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
SUMMARY:
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https://www.epa.gov/reviewing-new-chemicals-under-toxicsubstances-control-act-tsca/tsca-section-5a3c-determination-127.
https://www.epa.gov/reviewing-new-chemicals-under-toxicsubstances-control-act-tsca/tsca-section-5a3c-determination-125.
https://www.epa.gov/reviewing-new-chemicals-under-toxicsubstances-control-act-tsca/tsca-section-5a3c-determination-124.
https://www.epa.gov/reviewing-new-chemicals-under-toxicsubstances-control-act-tsca/tsca-section-5a3c-determination-123.
https://www.epa.gov/reviewing-new-chemicals-under-toxicsubstances-control-act-tsca/tsca-section-5a3c-determination-122.
https://www.epa.gov/reviewing-new-chemicals-under-toxicsubstances-control-act-tsca/tsca-section-5a3c-determination-121.
https://www.epa.gov/reviewing-new-chemicals-under-toxicsubstances-control-act-tsca/tsca-section-5a3c-determination-120.
https://www.epa.gov/reviewing-new-chemicals-under-toxicsubstances-control-act-tsca/tsca-section-5a3c-determination-119.
https://www.epa.gov/reviewing-new-chemicals-under-toxicsubstances-control-act-tsca/tsca-section-5a3c-determination-118.
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 October 1, 2018
to October 31, 2018.
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.
FOR FURTHER INFORMATION CONTACT:
BILLING CODE 6560–50–P
khammond on DSKBBV9HB2PROD with NOTICES
Website link
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.
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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 https://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 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 October 1, 2018
to October 31, 2018.
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Federal Register / Vol. 84, No. 111 / Monday, June 10, 2019 / Notices
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.
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–18–0224–0225 ....
(P–18–0224) Alkenoic acid, polymer with
alkenylcarbomonocycle,
[alkanediylbis(substitutedalkylene)] bis[heteromonocycle]
and (alkylalkenyl) aromatic, salt (generic name) and (P–
18–0225) Alkenoic acid, polymer with substituted
alkyloxirane, alkenylcarbomonocycle, alkyl substituted
alkyl alkanediol and (alkylalkenyl) aromatic salt (generic
name).
Poly[oxy(methyl-alkylendiyl)], a,a′,a″-1,2,3-alkanetriyltris[whydroxy-, polymer with 1,1′-alkylenebis[4isocyanatocarbomonocycle], 2-substituted ethyl acrylateand 2-substituted ethyl methacrylate-blocked (generic
name).
Genetically modified microorganism (generic name) ............
https://www.epa.gov/reviewing-new-chemicals-under-toxicsubstances-control-act-tsca/tsca-section-5a3c-determination-117.
P–18–0030 ..............
J–18–0019–0021 .....
J–18–0026–0027 .....
Biopolymer producing modified microorganism(s) with
chromosomally-borne modifications (generic name).
P–18–0041 ..............
2,5-Furandione, polymer with 2-ethyl-2-(hydroxymethyl)-1,3propanediol, 3a,4,5,6,7,7a-hexahydro-4,7-methano-1Hinden-5(or 6)-yl ester, ester with 2,3-dihydroxypropyl
neodecanoate.
alpha 1,3-polysaccharide (generic name) .............................
P–16–0581 ..............
khammond on DSKBBV9HB2PROD with NOTICES
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
26869
P–16–0575 ..............
P–16–0483–0484 ....
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Glucosyltransferase (International Union of Biochemistry
and Molecular Biology (IUBMB) enzyme nomenclature
recommendations: IUBMB Number 2.4.1.5).
(P–16–0483) Inorganic acids, metal salts, compds. with
modified heteroaromatics (generic name) and (P–16–
0484) inorganic acid, metal salt, compd. with substituted
aromatic heterocycle (generic name).
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https://www.epa.gov/reviewing-new-chemicals-under-toxicsubstances-control-act-tsca/tsca-section-5a3c-determination-116.
https://www.epa.gov/reviewing-new-chemicals-under-toxicsubstances-control-act-tsca/tsca-section-5a3c-determination-115.
https://www.epa.gov/reviewing-new-chemicals-under-toxicsubstances-control-act-tsca/tsca-section-5a3c-determination-114.
https://www.epa.gov/reviewing-new-chemicals-under-toxicsubstances-control-act-tsca/tsca-section-5a3c-determination-113.
https://www.epa.gov/reviewing-new-chemicals-under-toxicsubstances-control-act-tsca/tsca-section-5a3c-determination-112.
https://www.epa.gov/reviewing-new-chemicals-under-toxicsubstances-control-act-tsca/tsca-section-5a3c-determination-111.
https://www.epa.gov/reviewing-new-chemicals-under-toxicsubstances-control-act-tsca/tsca-section-5a3c-determination-110.
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26870
Federal Register / Vol. 84, No. 111 / Monday, June 10, 2019 / Notices
EPA case No.
Chemical identity
Website link
P–16–0380–0385 ....
https://www.epa.gov/reviewing-new-chemicals-under-toxicsubstances-control-act-tsca/tsca-section-5a3c-determination-109.
P–16–0354–0355 ....
(P–16–0380) Formic acid, compounds with hydrolyzed
bisphenol A-epichlorohydrin-polyethylene glycol ether
with bisphenol A (2:1) polymer-N1-(1,3dimethylbutylidene)-N2-[2-[(1, 3dimethylbutylidene)amino]ethyl]-1,2-ethanediaminedialdehyde-2-(methylamino)ethanol reaction products
acetates (salts) (generic name), (P–16–0381) propanoic
acid, 2-hydroxy-, compounds with hydrolyzed bisphenol
A-epichlorohydrin-polyethylene glycol ether with
bisphenol A (2:1) polymer-N1-(1,3-dimethylbutylidene)N2-[2-[(1, 3-dimethylbutylidene)amino]ethyl]-1,2ethanediamine-dialdehyde-2-(methylamino)ethanol reaction products formates (salts) (generic name), (P–16–
0382) formic acid, compounds with hydrolyzed bisphenol
A-epichlorohydrin-polyethylene glycol ether with
bisphenol A (2:1) polymer-N1-(1,3-dimethylbutylidene)N2-[2-[(1, 3-dimethylbutylidene)amino]ethyl]-1,2ethanediamine-dialdehyde-2-(methylamino)ethanol reaction products sulfamates(salts) (generic name), (P–16–
0383) formic acid, compounds with hydrolyzed bisphenol
A-epichlorohydrin-polyethylene glycol ether with
bisphenol A (2:1) polymer-N1-(1,3-dimethylbutylidene)N2-[2-[(1, 3-dimethylbutylidene)amino]ethyl]-1,2ethanediamine-dialdehyde-2-(methylamino)ethanol reaction products acetates (salts) (generic name), (P–16–
0384) propanoic acid, 2-hydroxy-, compds. with
hydrolyzed bisphenol A-epichlorohydrin-polyethylene glycol ether with bisphenol A (2:1) polymer-N1-(1,3dimethylbutylidene)-N2-[2-[(1, 3dimethylbutylidene)amino]ethyl]-1,2-ethanediaminedialdehyde-2-(methylamino)ethanol reaction products formates (salts) (generic name), and (P–16–0385) formic
acid, compounds with hydrolyzed bisphenol Aepichlorohydrin-polyethylene glycol ether with bisphenol
A (2:1) polymer-N1-(1,3-dimethylbutylidene)-N2-[2-[(1,3dimethylbutylidene)amino]ethyl]-1,2-ethanediaminedialdehyde-2-(methylamino)ethanol reaction products
sulfamates(salts) (generic name).
Esteramine (generic names) .................................................
P–16–0192 ..............
Silanized amorphous silica (generic name) ..........................
P–18–0227 ..............
D-Glucaric acid (CASRN: 87–73–0) ......................................
P–18–0137 ..............
Alkylsilsesquioxane, ethoxy-terminated (generic name) .......
P–18–0116 ..............
Fatty acid oil reaction product with fatty acid oil (generic
name).
P–18–0100 ..............
Substituted alkanoic acid polymer with alkylcarbonate,
alkanediols and isocyanate substituted carbomonocycles,
sodium salt, alkenoic acid substituted polyol reaction
products-blocked (generic name).
Alkenoic acid, ester with [oxybis(alkylene)]bis[alkyl-substituted alkanediol], polymer with alkylcarbonate,
alkanediols, substituted alkanoic acid and isocyanate and
alkyl substituted carbomonocycle, sodium salt (generic
name).
Waste plastics, polyester, depolymd. with glycols, polymers
with dicarboxylic acids (generic name).
P–18–0102 ..............
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P–18–0070 ..............
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https://www.epa.gov/reviewing-new-chemicals-under-toxicsubstances-control-act-tsca/tsca-section-5a3c-determination-108.
https://www.epa.gov/reviewing-new-chemicals-under-toxicsubstances-control-act-tsca/tsca-section-5a3c-determination-107.
https://www.epa.gov/reviewing-new-chemicals-under-toxicsubstances-control-act-tsca/tsca-section-5a3c-determination-106.
https://www.epa.gov/reviewing-new-chemicals-under-toxicsubstances-control-act-tsca/tsca-section-5a3c-determination-105.
https://www.epa.gov/reviewing-new-chemicals-under-toxicsubstances-control-act-tsca/tsca-section-5a3c-determination-104.
https://www.epa.gov/reviewing-new-chemicals-under-toxicsubstances-control-act-tsca/tsca-section-5a3c-determination-103.
https://www.epa.gov/reviewing-new-chemicals-under-toxicsubstances-control-act-tsca/tsca-section-5a3c-determination-103.
https://www.epa.gov/reviewing-new-chemicals-under-toxicsubstances-control-act-tsca/tsca-section-5a3c-determination-102.
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Federal Register / Vol. 84, No. 111 / Monday, June 10, 2019 / Notices
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. 2019–12081 Filed 6–7–19; 8:45 am]
BILLING CODE 6560–50–P
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
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
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:
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.
SUMMARY:
SUPPLEMENTARY INFORMATION:
khammond on DSKBBV9HB2PROD with NOTICES
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.
VerDate Sep<11>2014
16:45 Jun 07, 2019
Jkt 247001
26871
B. How can I get copies of this document present an unreasonable risk of injury to
health or the environment.
and other related information?
Unreasonable risk findings must be
The docket for this action, identified
made without consideration of costs or
by docket identification (ID) number
other non-risk factors, including an
EPA–HQ–OPPT–2018–0097, is available
unreasonable risk to a potentially
at https://www.regulations.gov or at the
exposed or susceptible subpopulation
Office of Pollution Prevention and
identified as relevant under the
Toxics Docket (OPPT Docket),
conditions of use. The term ‘‘conditions
Environmental Protection Agency
of use’’ is defined in TSCA section 3 to
Docket Center (EPA/DC), West William
mean ‘‘the circumstances, as determined
Jefferson Clinton Bldg., Rm. 3334, 1301
by the Administrator, under which a
Constitution Ave, NW, Washington, DC.
chemical substance is intended, known,
The Public Reading Room is open from
or reasonably foreseen to be
8:30 a.m. to 4:30 p.m., Monday through
manufactured, processed, distributed in
Friday, excluding legal holidays. The
commerce, used, or disposed of.’’
telephone number for the Public
EPA is required under TSCA section
Reading Room is (202) 566–1744, and
5(g) to publish in the Federal Register
the telephone number for the OPPT
a statement of its findings after its
Docket is (202) 566–0280. Please review review of a TSCA section 5(a) notice
the visitor instructions and additional
when EPA makes a finding that a new
information about the docket available
chemical substance or significant new
at https://www.epa.gov/dockets.
use is not likely to present an
unreasonable risk of injury to health or
II. What action is the Agency taking?
the environment. Such statements apply
This document lists the statements of
to PMNs, MCANs, and SNUNs
findings made by EPA after review of
submitted to EPA under TSCA section
notices submitted under TSCA section
5.
5(a) that certain new chemical
Anyone who plans to manufacture
substances or significant new uses are
(which includes import) a new chemical
not likely to present an unreasonable
substance for a non-exempt commercial
risk of injury to health or the
purpose and any manufacturer or
environment. This document presents
processor wishing to engage in a use of
statements of findings made by EPA
a chemical substance designated by EPA
during the period from January 1, 2019
as a significant new use must submit a
to March 31, 2019.
notice to EPA at least 90 days before
commencing manufacture of the new
III. What is the Agency’s authority for
chemical substance or before engaging
taking this action?
in the significant new use.
TSCA section 5(a)(3) requires EPA to
The submitter of a notice to EPA for
review a TSCA section 5(a) notice and
which EPA has made a finding of ‘‘not
make one of the following specific
likely to present an unreasonable risk of
findings:
injury to health or the environment’’
• The chemical substance or
may commence manufacture of the
significant new use presents an
chemical substance or manufacture or
unreasonable risk of injury to health or
processing for the significant new use
the environment;
notwithstanding any remaining portion
• The information available to EPA is of the applicable review period.
insufficient to permit a reasoned
IV. Statements of Administrator
evaluation of the health and
Findings Under TSCA Section 5(a)(3)(C)
environmental effects of the chemical
substance or significant new use;
In this unit, EPA provides the
• The information available to EPA is following information (to the extent that
insufficient to permit a reasoned
such information is not claimed as
evaluation of the health and
Confidential Business Information
environmental effects and the chemical
(CBI)) on the PMNs, MCANs and
substance or significant new use may
SNUNs for which, during this period,
present an unreasonable risk of injury to EPA has made findings under TSCA
health or the environment;
section 5(a)(3)(C) that the new chemical
• The chemical substance is or will
substances or significant new uses are
be produced in substantial quantities,
not likely to present an unreasonable
and such substance either enters or may risk of injury to health or the
reasonably be anticipated to enter the
environment:
environment in substantial quantities or
• EPA case number assigned to the
there is or may be significant or
TSCA section 5(a) notice.
substantial human exposure to the
• Chemical identity (generic name, if
substance; or
the specific name is claimed as CBI).
• Website link to EPA’s decision
• The chemical substance or
document describing the basis of the
significant new use is not likely to
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]]>Agencies
[Federal Register Volume 84, Number 111 (Monday, June 10, 2019)]
[Notices]
[Pages 26868-26871]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-12081]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2018-0097; FRL-9991-67]
Certain New Chemicals or Significant New Uses; Statements of
Findings for October 2018
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 October 1, 2018 to October 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: [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 https://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 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 October 1, 2018 to October 31, 2018.
[[Page 26869]]
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-18-0224-0225............ (P-18-0224) Alkenoic https://www.epa.gov/
acid, polymer with reviewing-new-
alkenylcarbomonocycl chemicals-under-
e, toxic-substances-
[alkanediylbis(subst control-act-tsca/
itutedalkylene)] tsca-section-5a3c-
bis[heteromonocycle] determination-117.
and (alkylalkenyl)
aromatic, salt
(generic name) and
(P-18-0225) Alkenoic
acid, polymer with
substituted
alkyloxirane,
alkenylcarbomonocycl
e, alkyl substituted
alkyl alkanediol and
(alkylalkenyl)
aromatic salt
(generic name).
P-18-0030................. Poly[oxy(methyl- https://www.epa.gov/
alkylendiyl)], reviewing-new-
a,a',a''-1,2,3- chemicals-under-
alkanetriyltris[w- toxic-substances-
hydroxy-, polymer control-act-tsca/
with 1,1'- tsca-section-5a3c-
alkylenebis[4- determination-116.
isocyanatocarbomonoc
ycle], 2-substituted
ethyl acrylate- and
2-substituted ethyl
methacrylate-blocked
(generic name).
J-18-0019-0021............ Genetically modified https://www.epa.gov/
microorganism reviewing-new-
(generic name). chemicals-under-
toxic-substances-
control-act-tsca/
tsca-section-5a3c-
determination-115.
J-18-0026-0027............ Biopolymer producing https://www.epa.gov/
modified reviewing-new-
microorganism(s) chemicals-under-
with chromosomally- toxic-substances-
borne modifications control-act-tsca/
(generic name). tsca-section-5a3c-
determination-114.
P-18-0041................. 2,5-Furandione, https://www.epa.gov/
polymer with 2-ethyl- reviewing-new-
2-(hydroxymethyl)- chemicals-under-
1,3-propanediol, toxic-substances-
3a,4,5,6,7,7a- control-act-tsca/
hexahydro-4,7- tsca-section-5a3c-
methano-1H-inden- determination-113.
5(or 6)-yl ester,
ester with 2,3-
dihydroxypropyl
neodecanoate.
P-16-0581................. alpha 1,3- https://www.epa.gov/
polysaccharide reviewing-new-
(generic name). chemicals-under-
toxic-substances-
control-act-tsca/
tsca-section-5a3c-
determination-112.
P-16-0575................. Glucosyltransferase https://www.epa.gov/
(International Union reviewing-new-
of Biochemistry and chemicals-under-
Molecular Biology toxic-substances-
(IUBMB) enzyme control-act-tsca/
nomenclature tsca-section-5a3c-
recommendations: determination-111.
IUBMB Number
2.4.1.5).
P-16-0483-0484............ (P-16-0483) Inorganic https://www.epa.gov/
acids, metal salts, reviewing-new-
compds. with chemicals-under-
modified toxic-substances-
heteroaromatics control-act-tsca/
(generic name) and tsca-section-5a3c-
(P-16-0484) determination-110.
inorganic acid,
metal salt, compd.
with substituted
aromatic heterocycle
(generic name).
[[Page 26870]]
P-16-0380-0385............ (P-16-0380) Formic https://www.epa.gov/
acid, compounds with reviewing-new-
hydrolyzed bisphenol chemicals-under-
A-epichlorohydrin- toxic-substances-
polyethylene glycol control-act-tsca/
ether with bisphenol tsca-section-5a3c-
A (2:1) polymer-N1- determination-109.
(1,3-
dimethylbutylidene)-
N2-[2-[(1, 3-
dimethylbutylidene)a
mino]ethyl]-1,2-
ethanediamine-
dialdehyde-2-
(methylamino)ethanol
reaction products
acetates (salts)
(generic name), (P-
16-0381) propanoic
acid, 2-hydroxy-,
compounds with
hydrolyzed bisphenol
A-epichlorohydrin-
polyethylene glycol
ether with bisphenol
A (2:1) polymer-N1-
(1,3-
dimethylbutylidene)-
N2-[2-[(1, 3-
dimethylbutylidene)a
mino]ethyl]-1,2-
ethanediamine-
dialdehyde-2-
(methylamino)ethanol
reaction products
formates (salts)
(generic name), (P-
16-0382) formic
acid, compounds with
hydrolyzed bisphenol
A-epichlorohydrin-
polyethylene glycol
ether with bisphenol
A (2:1) polymer-N1-
(1,3-
dimethylbutylidene)-
N2-[2-[(1, 3-
dimethylbutylidene)a
mino]ethyl]-1,2-
ethanediamine-
dialdehyde-2-
(methylamino)ethanol
reaction products
sulfamates(salts)
(generic name), (P-
16-0383) formic
acid, compounds with
hydrolyzed bisphenol
A-epichlorohydrin-
polyethylene glycol
ether with bisphenol
A (2:1) polymer-N1-
(1,3-
dimethylbutylidene)-
N2-[2-[(1, 3-
dimethylbutylidene)a
mino]ethyl]-1,2-
ethanediamine-
dialdehyde-2-
(methylamino)ethanol
reaction products
acetates (salts)
(generic name), (P-
16-0384) propanoic
acid, 2-hydroxy-,
compds. with
hydrolyzed bisphenol
A-epichlorohydrin-
polyethylene glycol
ether with bisphenol
A (2:1) polymer-N1-
(1,3-
dimethylbutylidene)-
N2-[2-[(1, 3-
dimethylbutylidene)a
mino]ethyl]-1,2-
ethanediamine-
dialdehyde-2-
(methylamino)ethanol
reaction products
formates (salts)
(generic name), and
(P-16-0385) formic
acid, compounds with
hydrolyzed bisphenol
A-epichlorohydrin-
polyethylene glycol
ether with bisphenol
A (2:1) polymer-N1-
(1,3-
dimethylbutylidene)-
N2-[2-[(1,3-
dimethylbutylidene)a
mino]ethyl]-1,2-
ethanediamine-
dialdehyde-2-
(methylamino)ethanol
reaction products
sulfamates(salts)
(generic name).
P-16-0354-0355............ Esteramine (generic https://www.epa.gov/
names). reviewing-new-
chemicals-under-
toxic-substances-
control-act-tsca/
tsca-section-5a3c-
determination-108.
P-16-0192................. Silanized amorphous https://www.epa.gov/
silica (generic reviewing-new-
name). chemicals-under-
toxic-substances-
control-act-tsca/
tsca-section-5a3c-
determination-107.
P-18-0227................. D-Glucaric acid https://www.epa.gov/
(CASRN: 87-73-0). reviewing-new-
chemicals-under-
toxic-substances-
control-act-tsca/
tsca-section-5a3c-
determination-106.
P-18-0137................. Alkylsilsesquioxane, https://www.epa.gov/
ethoxy-terminated reviewing-new-
(generic name). chemicals-under-
toxic-substances-
control-act-tsca/
tsca-section-5a3c-
determination-105.
P-18-0116................. Fatty acid oil https://www.epa.gov/
reaction product reviewing-new-
with fatty acid oil chemicals-under-
(generic name). toxic-substances-
control-act-tsca/
tsca-section-5a3c-
determination-104.
P-18-0100................. Substituted alkanoic https://www.epa.gov/
acid polymer with reviewing-new-
alkylcarbonate, chemicals-under-
alkanediols and toxic-substances-
isocyanate control-act-tsca/
substituted tsca-section-5a3c-
carbomonocycles, determination-103.
sodium salt,
alkenoic acid
substituted polyol
reaction products-
blocked (generic
name).
P-18-0102................. Alkenoic acid, ester https://www.epa.gov/
with reviewing-new-
[oxybis(alkylene)]bi chemicals-under-
s[alkyl-substituted toxic-substances-
alkanediol], polymer control-act-tsca/
with alkylcarbonate, tsca-section-5a3c-
alkanediols, determination-103.
substituted alkanoic
acid and isocyanate
and alkyl
substituted
carbomonocycle,
sodium salt (generic
name).
P-18-0070................. Waste plastics, https://www.epa.gov/
polyester, depolymd. reviewing-new-
with glycols, chemicals-under-
polymers with toxic-substances-
dicarboxylic acids control-act-tsca/
(generic name). tsca-section-5a3c-
determination-102.
------------------------------------------------------------------------
[[Page 26871]]
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. 2019-12081 Filed 6-7-19; 8:45 am]
BILLING CODE 6560-50-P
