Certain New Chemicals or Significant New Uses; Statements of Findings for November and December 2018
| Citation | 84 FR 26866 |
| Record Number | 2019-12080 |
| Published date | 10 June 2019 |
| Section | Notices |
| Court | Environmental Protection Agency |
Federal Register, Volume 84 Issue 111 (Monday, June 10, 2019)
[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:
[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 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).
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EPA case No. Chemical identity Website link
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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).
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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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