Certain New Chemicals or Significant New Uses; Statements of Findings for July 2019
| Citation | 84 FR 57414 |
| Record Number | 2019-23370 |
| Published date | 25 October 2019 |
| Section | Notices |
| Court | Environmental Protection Agency |
Federal Register, Volume 84 Issue 207 (Friday, October 25, 2019)
[Federal Register Volume 84, Number 207 (Friday, October 25, 2019)]
[Notices]
[Pages 57414-57416]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-23370]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2019-0271; FRL-9999-46]
Certain New Chemicals or Significant New Uses; Statements of
Findings for July 2019
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 July 1, 2019 to July 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:
[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-2019-0271, 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 July 1, 2019 to July 31, 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:
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
[[Page 57415]]
(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-18-0035................... Methacrylic acid https://www.epa.gov/
heterocyclic alkyl reviewing-new-
ester (generic chemicals-under-
name). toxic-substances-
control-act-tsca/
tsca-section-5a3c-
determination-275.
P-18-0009................... Phosphonic acid, https://www.epa.gov/
dimethyl ester, reviewing-new-
polymer with alkyl chemicals-under-
diols (generic toxic-substances-
name). control-act-tsca/
tsca-section-5a3c-
determination-274.
P-17-0395................... Alkyl tri https://www.epa.gov/
dithiocarbmate tri reviewing-new-
salt (generic name). chemicals-under-
toxic-substances-
control-act-tsca/
tsca-section-5a3c-
determination-273.
P-17-0346................... Phosphonium, https://www.epa.gov/
triphenylpropyl-, reviewing-new-
bromide (CASRN: chemicals-under-
6228-47-3). toxic-substances-
control-act-tsca/
tsca-section-5a3c-
determination-272.
P-17-0312, P-17-0313, P-17- (P-17-0312) Organic https://www.epa.gov/
0314, P-17-0315, P-17-0316, acid, compds. with reviewing-new-
P-17-0317. bisphenol A- chemicals-under-
epichlorohydrin- toxic-substances-
polypropylene control-act-tsca/
glycol diglycidyl tsca-section-5a3c-
ether polymer- determination-271.
disubstituted amine-
disubstituted
polypropylene
glycol reaction
products; (P-17-
0313) Phenol, 4,4'-
(1-
methylethylidene)
bis-, polymer with
2-
(chloromethyl)oxira
ne and alpha-(2-
oxiranylmethyl)-
omega-(2-
oxiranylmethoxy)pol
y[oxy(methyl-1,2-
ethanediyl)],
reaction products
with disubstituted
amine and
disubstituted
polypropylene
glycol, organic
acid salts; (P-17-
0314) Organic acid,
2-substituted-,
compds. with
bisphenol A-
epichlorohydrin-
polypropylene
glycol diglycidyl
ether polymer-
disubstituted
aminedisubstituted
polypropylene
glycol reaction
products; (P-17-
0315) Phenol, 4,4'-
(1-
methylethylidene)bi
s-, polymer with
alpha-(2-
substituted-
methylethyl)-omega-
(2-substituted-
methylethoxy)poly[o
xy (methyl-1,2-
ethanediyl)], 2-
(chloromethyl)oxira
ne and alpha-(2-
oxiranylmethyl)-
omega-(2-
oxiranylmethoxy)pol
y[oxy(methyl-1,2-
ethanediyl)],
alkylphenyl ethers,
reaction products
with disubstituted
amine, organic acid
salts; (P-17-0316)
Organic acid,
compds. with
bisphenol A-
epichlorohydrin-
disubstituted
polypropylene
glycol-
polypropylene
glycol diglycidyl
ether polymer
alkylphenyl ethers-
disubstituted amine
reaction products;
(P-17-0317) Organic
acid, compds. with
bisphenol A-
epichlorohydrin-
polypropylene
glycol diglycidyl
ether polymer-
disubstituted
polypropylene
glycol reaction
products (generic
names).
P-19-0096................... Benzofuranone, https://www.epa.gov/
bis(branched alkyl)- reviewing-new-
[dialkyl[tetrakis(b chemicals-under-
ranched alkyl)- toxic-substances-
alkyl-dibenzo- control-act-tsca/
substitutedphosphit tsca-section-5a3c-
e-yl] phenyl]- determination-270.
(generic name).
P-19-0062................... Hydrochlorofluoroole https://www.epa.gov/
fin (generic name). reviewing-new-
chemicals-under-
toxic-substances-
control-act-tsca/
tsca-section-5a3c-
determination-269.
P-19-0029................... Phosphonium, https://www.epa.gov/
tributylethyl-, reviewing-new-
diethyl phosphate chemicals-under-
(1:1) (CASRN: 20445- toxic-substances-
94-7). control-act-tsca/
tsca-section-5a3c-
determination-268.
P-18-0394................... Substituted benzylic https://www.epa.gov/
ether polyethylene reviewing-new-
glycol alkyl ether chemicals-under-
derivative (generic toxic-substances-
name). control-act-tsca/
tsca-section-5a3c-
determination-267.
P-18-0300................... Heteromonocycle, https://www.epa.gov/
alkenoic 1:1 salt, reviewing-new-
polymer with alpha- chemicals-under-
(2-methyl-1-oxo-2- toxic-substances-
propen-1-y)l- control-act-tsca/
omegamethoxypoly(ox tsca-section-5a3c-
y-1,2-ethanediyl) determination-266.
and methylalkenoic
acid (generic name).
P-18-0286................... Propane, 1,1,1,3,3,3- https://www.epa.gov/
hexafluoro-2- reviewing-new-
methoxy- (CASRN: chemicals-under-
13171-18-1). toxic-substances-
control-act-tsca/
tsca-section-5a3c-
determination-265.
P-18-0257................... Phosphoric acid, https://www.epa.gov/
potassium salt reviewing-new-
(2:3) (CASRN: 66923- chemicals-under-
00-0). toxic-substances-
control-act-tsca/
tsca-section-5a3c-
determination-264.
P-18-0103................... Alkylnitrile https://www.epa.gov/
imidazole (generic reviewing-new-
name). chemicals-under-
toxic-substances-
control-act-tsca/
tsca-section-5a3c-
determination-263.
P-16-0442, P-16-0443, P-16- (P-16-0442) https://www.epa.gov/
0444, P-16-0445. Carboxylic acids, reviewing-new-
unsaturated, chemicals-under-
polymers with toxic-substances-
disubstituted control-act-tsca/
amine, alkanediol, tsca-section-5a3c-
substituted determination-262.
alkylpropanoic
acid, alkanedioic
acid and
substituted
isocyanatocycloalka
ne, compds with
alkylamine; (P-16-
0443) Carboxylic
acids, unsaturated,
hydrogenated
polymers with
disubstituted
amine, alkanediol,
substituted
alkylpropanoic
acid, alkanedioic
acid and
substituted
isocyanatocycloalka
ne, compds with
alkylamine; (P-16-
0444) Carboxylic
acids, unsaturated,
polymers with
substituted
alkanediamine,
alkanediol,
substituted
alkylpropanoic
acid, alkanedioic
acid and
substituted
isocyanatocycloalka
ne, compds with
alkylamineAmine
salted
polyurethane; (P-16-
0445) Carboxylic
acids, unsaturated,
hydrogenated
polymers with
substituted
alkanediamine,
alkanediol,
substituted
alkylpropanoic
acid, alkanedioic
acid and
substituted
isocyanatocycloalka
ne, compds with
alkylamine (generic
names).
P-16-0092................... Polymeric polyamine https://www.epa.gov/
(generic name). reviewing-new-
chemicals-under-
toxic-substances-
control-act-tsca/
tsca-section-5a3c-
determination-261.
P-18-0401................... Glycerides, C16-18 https://www.epa.gov/
and CI8-unsatd. reviewing-new-
mono- and di-, chemicals-under-
citrates (CASRN: toxic-substances-
91052-16-3). control-act-tsca/
tsca-section-5a3c-
determination-260.
P-18-0177................... Waxes and Waxy https://www.epa.gov/
substances, rice reviewing-new-
bran, oxidized chemicals-under-
(CASRN: 1883583-80- toxic-substances-
9). control-act-tsca/
tsca-section-5a3c-
determination-259.
P-17-0362................... Aliphatic phosphoric https://www.epa.gov/
amide ester reviewing-new-
(generic name). chemicals-under-
toxic-substances-
control-act-tsca/
tsca-section-5a3c-
determination-258.
[[Page 57416]]
P-19-0081................... 2-Propenoic acid, https://www.epa.gov/
alkyl ester, reviewing-new-
reaction products chemicals-under-
with mixed toxic-substances-
substituted alkyl control-act-tsca/
esters of tsca-section-5a3c-
phosphorodithioic determination-257.
acid and propylene
oxide (generic
name).
P-18-0185................... Fatty acid, polymer https://www.epa.gov/
with alkanedioic reviewing-new-
acid dialkyl ester, chemicals-under-
hydroxyl alkyl toxic-substances-
substituted control-act-tsca/
alkanediol, tsca-section-5a3c-
substituted determination-256.
carbomonocycle and
alkylol substituted
alkane (generic
name); polymer
exemption flag.
P-18-0285................... Specific: https://www.epa.gov/
Butanedioic acid, 2- reviewing-new-
methylene-, polymer chemicals-under-
with 2-methyl-2-[(1- toxic-substances-
oxo-2-propen-1- control-act-tsca/
yl)amino]-1- tsca-section-5a3c-
propanesulfonic determination-255.
acid, sodium zinc
salt (CASRN:
2220235-78-7).
P-18-0223................... Alkane, https://www.epa.gov/
bis(alkoxymethyl)- reviewing-new-
dimethyl- (generic chemicals-under-
name). toxic-substances-
control-act-tsca/
tsca-section-5a3c-
determination-254.
P-19-0068................... 1,4- https://www.epa.gov/
benzenedicarboxylic reviewing-new-
acid, polymer with chemicals-under-
diol, 5-amino-1,3,3- toxic-substances-
trimethylcyclohexan control-act-tsca/
emethanamine, 1,2- tsca-section-5a3c-
ethanediol and urea determination-253.
(generic name).
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Authority: 15 U.S.C. 2601 et seq.
Dated: October 3, 2019.
Leo Schweer,
Chief, New Chemicals Management Branch, Chemical Control Division,
Office of Pollution Prevention and Toxics.
[FR Doc. 2019-23370 Filed 10-24-19; 8:45 am]
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