[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).
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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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