Certain New Chemicals; Receipt and Status Information for December 2018, 14368-14372 [2019-07094]
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14368
Federal Register / Vol. 84, No. 69 / Wednesday, April 10, 2019 / Notices
If you are interested in information
that is not included in these tables, you
may contact EPA’s technical
information contact or general
information contact as described under
FOR FURTHER INFORMATION CONTACT to
access additional non-CBI information
that may be available.
Authority: 15 U.S.C. 2601 et seq.
Dated: March 19, 2019.
Pamela Myrick,
Director, Information Management Division,
Office of Pollution Prevention and Toxics.
[FR Doc. 2019–07082 Filed 4–9–19; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–OPPT–2018–0411; FRL–9990–59]
Certain New Chemicals; Receipt and
Status Information for December 2018
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
EPA is required under the
Toxic Substances Control Act (TSCA),
as amended by the Frank R. Lautenberg
Chemical Safety for the 21st Century
Act, to make information publicly
available and to publish information in
the Federal Register pertaining to
submissions under TSCA Section 5,
including notice of receipt of a
Premanufacture notice (PMN),
Significant New Use Notice (SNUN) or
Microbial Commercial Activity Notice
(MCAN), including an amended notice
or test information; an exemption
application (Biotech exemption); an
application for a test marketing
exemption (TME), both pending and/or
concluded; a notice of commencement
(NOC) of manufacture (including
import) for new chemical substances;
and a periodic status report on new
chemical substances that are currently
under EPA review or have recently
concluded review. This document
covers the period from 12/01/2018 to
12/31/2018.
DATES: Comments identified by the
specific case number provided in this
document must be received on or before
May 10, 2019.
ADDRESSES: Submit your comments,
identified by docket identification (ID)
number EPA–HQ–OPPT–2018–0411,
and the specific case number for the
chemical substance related to your
comment, by one of the following
methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the online
instructions for submitting comments.
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SUMMARY:
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Do not submit electronically any
information you consider to be
Confidential Business Information (CBI)
or other information whose disclosure is
restricted by statute.
• Mail: Document Control Office
(7407M), Office of Pollution Prevention
and Toxics (OPPT), Environmental
Protection Agency, 1200 Pennsylvania
Ave. NW, Washington, DC 20460–0001.
• Hand Delivery: To make special
arrangements for hand delivery or
delivery of boxed information, please
follow the instructions at https://
www.epa.gov/dockets/contacts.html.
Additional instructions on
commenting or visiting the docket,
along with more information about
dockets generally, is available at https://
www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: For
technical information contact: Jim
Rahai, Information Management
Division (7407M), Office of Pollution
Prevention and Toxics, Environmental
Protection Agency, 1200 Pennsylvania
Ave. NW, Washington, DC 20460–0001;
telephone number: (202) 564–8593;
email address: rahai.jim@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. Executive Summary
A. What action is the Agency taking?
This document provides the receipt
and status reports for the period from
12/01/2018 to 12/31/2018. The Agency
is providing notice of receipt of PMNs,
SNUNs and MCANs (including
amended notices and test information);
an exemption application under 40 CFR
part 725 (Biotech exemption); TMEs,
both pending and/or concluded; NOCs
to manufacture a new chemical
substance; and a periodic status report
on new chemical substances that are
currently under EPA review or have
recently concluded review.
EPA is also providing information on
its website about cases reviewed under
the amended TSCA, including the
section 5 PMN/SNUN/MCAN and
exemption notices received, the date of
receipt, the final EPA determination on
the notice, and the effective date of
EPA’s determination for PMN/SNUN/
MCAN notices on its website at: https://
www.epa.gov/reviewing-new-chemicalsunder-toxic-substances-control-act-tsca/
status-pre-manufacture-notices. This
information is updated on a weekly
basis.
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B. What is the Agency’s authority for
taking this action?
Under the TSCA, 15 U.S.C. 2601 et
seq., a chemical substance may be either
an ‘‘existing’’ chemical substance or a
‘‘new’’ chemical substance. Any
chemical substance that is not on EPA’s
TSCA Inventory of Chemical Substances
(TSCA Inventory) is classified as a ‘‘new
chemical substance,’’ while a chemical
substance that is listed on the TSCA
Inventory is classified as an ‘‘existing
chemical substance.’’ (See TSCA section
3(11).) For more information about the
TSCA Inventory go to: https://
www.epa.gov/tsca-inventory.
Any person who intends to
manufacture (including import) a new
chemical substance for a non-exempt
commercial purpose, or to manufacture
or process a chemical substance in a
non-exempt manner for a use that EPA
has determined is a significant new use,
is required by TSCA section 5 to
provide EPA with a PMN, MCAN or
SNUN, as appropriate, before initiating
the activity. EPA will review the notice,
make a risk determination on the
chemical substance or significant new
use, and take appropriate action as
described in TSCA section 5(a)(3).
TSCA section 5(h)(1) authorizes EPA
to allow persons, upon application and
under appropriate restrictions, to
manufacture or process a new chemical
substance, or a chemical substance
subject to a significant new use rule
(SNUR) issued under TSCA section
5(a)(2), for ‘‘test marketing’’ purposes,
upon a showing that the manufacture,
processing, distribution in commerce,
use, and disposal of the chemical will
not present an unreasonable risk of
injury to health or the environment.
This is referred to as a test marketing
exemption, or TME. For more
information about the requirements
applicable to a new chemical go to:
https://www.epa.gov/oppt/newchems.
Under TSCA sections 5 and 8 and
EPA regulations, EPA is required to
publish in the Federal Register certain
information, including notice of receipt
of a PMN/SNUN/MCAN (including
amended notices and test information);
an exemption application under 40 CFR
part 725 (biotech exemption); an
application for a TME, both pending
and concluded; NOCs to manufacture a
new chemical substance; and a periodic
status report on the new chemical
substances that are currently under EPA
review or have recently concluded
review.
C. Does this action apply to me?
This action provides information that
is directed to the public in general.
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Federal Register / Vol. 84, No. 69 / Wednesday, April 10, 2019 / Notices
1. Submitting confidential business
information (CBI). Do not submit this
information to EPA through
regulations.gov or email. Clearly mark
the part or all of the information that
you claim to be CBI. For CBI
information in a disk or CD–ROM that
you mail to EPA, mark the outside of the
disk or CD–ROM as CBI and then
identify electronically within the disk or
CD–ROM the specific information that
is claimed as CBI. In addition to one
complete version of the comment that
includes information claimed as CBI, a
copy of the comment that does not
contain the information claimed as CBI
must be submitted for inclusion in the
public docket. Information so marked
will not be disclosed except in
accordance with procedures set forth in
40 CFR part 2.
2. Tips for preparing your comments.
When preparing and submitting your
comments, see the commenting tips at
https://www.epa.gov/dockets/
comments.html.
pending or concluded. In 1995, the
Agency modified its approach and
streamlined the information published
in the Federal Register after providing
notice of such changes to the public and
an opportunity to comment (See the
Federal Register of May 12, 1995 (60 FR
25798) (FRL–4942–7). Since the passage
of the Lautenberg amendments to TSCA
in 2016, public interest in information
on the status of section 5 cases under
EPA review and, in particular, the final
determination of such cases, has
increased. In an effort to be responsive
to the regulated community, the users of
this information, and the general public,
to comply with the requirements of
TSCA, to conserve EPA resources and to
streamline the process and make it more
timely, EPA is providing information on
its website about cases reviewed under
the amended TSCA, including the
section 5 PMN/SNUN/MCAN and
exemption notices received, the date of
receipt, the final EPA determination on
the notice, and the effective date of
EPA’s determination for PMN/SNUN/
MCAN notices on its website at: https://
www.epa.gov/reviewing-new-chemicalsunder-toxic-substances-control-act-tsca/
status-pre-manufacture-notices. This
information is updated on a weekly
basis.
II. Status Reports
III. Receipt Reports
In the past, EPA has published
individual notices reflecting the status
of TSCA section 5 filings received,
For the PMN/SNUN/MCANs received
by EPA during this period, Table I
provides the following information (to
D. Does this action have any
incremental economic impacts or
paperwork burdens?
No.
E. What should I consider as I prepare
my comments for EPA?
14369
the extent that such information is not
subject to a CBI claim) on the notices
received by EPA during this period: The
EPA case number assigned to the notice
that indicates whether the submission is
an initial submission, or an amendment,
a notation of which version was
received, the date the notice was
received by EPA, the submitting
manufacturer (i.e., domestic producer or
importer), the potential uses identified
by the manufacturer in the notice, and
the chemical substance identity.
As used in each of the tables in this
unit, (S) indicates that the information
in the table is the specific information
provided by the submitter, and (G)
indicates that this information in the
table is generic information because the
specific information provided by the
submitter was claimed as CBI.
Submissions which are initial
submissions will not have a letter
following the case number. Submissions
which are amendments to previous
submissions will have a case number
followed by the letter ‘‘A’’ (e.g., P–18–
1234A). The version column designates
submissions in sequence as ‘‘1’’, ‘‘2’’,
‘‘3’’, etc. Note that in some cases, an
initial submission is not numbered as
version 1; this is because earlier
versions were rejected as incomplete or
invalid submissions. Note also that
future versions of the following tables
may adjust slightly as the Agency works
to automate population of the data in
the tables.
TABLE I—PMN/SNUN/MCANS RECEIVED FROM 12/01/2018 TO 12/31/2018
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Case No.
Received
date
Version
Manufacturer
Use
Chemical substance
J–19–0011 ....................
1
12/23/2018
Danisco US, Inc ...........
(G) Production of a chemical
substance.
P–19–0011 ...................
4
12/20/2018
P–19–0030 ...................
2
12/18/2018
Shin etsu Silicones of
America.
CBI ...............................
(G) Additive to the EPDM
rubber compounds.
(G) Water Systems ................
P–19–0031 ...................
2
12/28/2018
CBI ...............................
(S) Curing agent for epoxy
coating systems.
P–19–0034 ...................
1
12/6/2018
CBI ...............................
(G) Contained use as a component of tires.
P–19–0035 ...................
3
12/10/2018
Firmenich, Inc ..............
(G) Fragrance ........................
P–19–0036 ...................
1
12/10/2018
Ethox Chemicals, LLC
(S) As an additive to polymers for improvement in
gas barrier performance.
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(G) Genetically modified
microorganism for the production of a chemical substance.
(G) Polysulfides, bis[3(trialkoxysilyl)propyl].
(G) Triethanolamine modified
Phosphinicocarboxylates,
sodium salts.
(G) Phenol, 4,4’-(1methylethylidene)bis-, polymer with formaldehyde, 2(chloromethyl)oxirane,
alpha-hydro-omegahydroxypoly(oxy-1,2ethanediyl), and
polyamines.
(G) Metal, bis(2,4pentanedionato-kO2,kO4)-,
(T–4)-.
(S) Acetamide, 2-(4methylphenoxy)-N–1Hpyrazol-3-yl-N-(2thienylmethyl)-.
(S) 1,4-Benzenedicarboxylic
acid, 1,4-bis(2phenoxyethyl) ester.
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Federal Register / Vol. 84, No. 69 / Wednesday, April 10, 2019 / Notices
TABLE I—PMN/SNUN/MCANS RECEIVED FROM 12/01/2018 TO 12/31/2018—Continued
Case No.
Received
date
Version
Manufacturer
Use
Chemical substance
(G) D-Glucaric acid, mixed alkali metal salt.
(S) Fatty acids, coco, iso-Bu
esters.
(G) Alkyl bis(dialkylamino
alkyl) amide.
(G) Alkyl diester, polymer with
(dialkylamino alkyl) amine
and bis(halogenated alkyl)
ether.
(G) Alkyl diester, polymer with
(dialkylamino alkyl) amine
and bis(halogenated alkyl)
ether.
(G) Alkyl dicarboxylic acid,
polymer with (dialkylamino
alkyl) amine and
bis(halogenated alkyl)
ether.
(G) Alkyl bis(dialkylamino
alkyl) amide polymer with
bis(halogenated alkyl)
ether.
(G) Non-metal tetrakis
(hydroxyalkyl)-, halide,
polymer with amide
oxidized.
(G) Potassium Titanate.
P–19–0037 ...................
1
12/11/2018
CBI ...............................
(G) Chemical intermediate ....
P–19–0038 ...................
2
12/14/2018
P–19–0040 ...................
1
12/20/2018
Allan Chemical Corporation.
CBI ...............................
(S) Ink carrier for the ceramic
industries.
(G) Intermediate ....................
P–19–0041 ...................
1
12/20/2018
CBI ...............................
(G) Oil water separation ........
P–19–0042 ...................
1
12/20/2018
CBI ...............................
(G) Oil water separation ........
P–19–0043 ...................
1
12/20/2018
CBI ...............................
(G) Oil water separation ........
P–19–0044 ...................
1
12/20/2018
CBI ...............................
(G) Oil water separation ........
P–19–0045 ...................
1
12/21/2018
CBI ...............................
(G) Component of textile
coating.
SN–19–0002 .................
2
12/20/2018
Otsuka Chemical America, Inc.
(G) Friction and wear stabilizer in certain solid composite articles.
In Table II. of this unit, EPA provides
the following information (to the extent
that such information is not claimed as
CBI) on the NOCs received by EPA
during this period: The EPA case
number assigned to the NOC including
whether the submission was an initial
or amended submission, the date the
NOC was received by EPA, the date of
commencement provided by the
submitter in the NOC, a notation of the
type of amendment (e.g., amendment to
generic name, specific name, technical
contact information, etc.) and chemical
substance identity.
TABLE II—NOCS RECEIVED FROM 12/01/2018 TO 12/31/2018
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Case No.
Received date
Commencement date
If amendment, type of
amendment
J–16–0021 .................
J–18–0026 .................
12/04/2018
12/21/2018
12/04/2018
11/30/2018
........................................
........................................
J–18–0027 .................
12/21/2018
12/07/2018
........................................
J–18–0044 .................
P–12–0168 ................
12/21/2018
12/13/2018
11/26/2018
12/07/2018
........................................
........................................
P–16–0150 ................
P–16–0173A ..............
12/20/2018
12/20/2018
11/29/2018
06/06/2016
P–16–0221 ................
P–17–0330 ................
12/14/2018
12/11/2018
12/13/2018
12/03/2018
........................................
Updated CBI substantiation
for importing site and update to generic chemical
name.
........................................
........................................
P–17–0332 ................
12/14/2018
11/20/2018
........................................
P–18–0002 ................
P–18–0147 ................
12/05/2018
12/13/2018
12/05/2018
11/29/2018
........................................
........................................
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Chemical substance
(G) Modified trichoderma reesei.
(G) Biopolymer producing modified microorganism(s),
with chromosomally-borne modifications.
(G) Biopolymer producing modified microorganism(s),
with chromosomally-borne modifications.
(S) Saccharomyces cerevisae NE095.
(S) 1,3,5-Triazine-2,4,6-triamine, N-(4,6-diamino-1,3,5triazin-2-yl)-.
(G) Chlorofluorocarbon.
(G) Aminoalkyl alaninate sodium salt (1:1), polymer
with alkyldiol, dialkyl-alkanediol, alkyldioic acid,
alkyldiol,
polyol,
cycloaliphatic
diisocyanate,
polyalkylene glycol mono-alkyl ether-blocked.
(G) Fluorinated organopolysilazane.
(G) Hexanedioic acid, polymer with trifuntional polyol,
1,1′-methylenebis [isocyanatobenzene], and 2,2′oxybis [ethanol].
(G)
Benzenesulfonic
acid,
(alkenediyl)bis[[[(hydroxyalkyl)amino]- (phenylamino)triazin-2-yl]amino]-, N-(hydroxyalkyl) derivs., salts.
(S) Phosphinic acid, P,P-diethyl-, sodium salt (1:1).
(G) Phenol, 4-ethenyl-, 1-substituted, polymer with 1(1,1-substituted)-4-ethenylbenzene
and
ethenylbenzene, 2, 2′-(1,2-diazenediyl)bis[2-substituted]-initiated, hydrolyzed.
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Federal Register / Vol. 84, No. 69 / Wednesday, April 10, 2019 / Notices
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TABLE II—NOCS RECEIVED FROM 12/01/2018 TO 12/31/2018—Continued
Case No.
Commencement date
Received date
If amendment, type of
amendment
P–18–0212 ................
12/11/2018
12/07/2018
........................................
P–18–0261 ................
P–18–0279 ................
12/06/2018
12/17/2018
12/05/2018
12/14/2018
........................................
........................................
In Table III. of this unit, EPA provides
the following information (to the extent
such information is not subject to a CBI
claim) on the test information received
Chemical substance
(G) Substituted carbomonocycle, polymer with alkyl
alkenoate, alkenyl substituted carbomonocycle, substituted alkanediol, heteropolycycle, alkylene glycol
and alkenoic acid, compd. with alkylamino alkanol.
(G) Metal, alkylcarboxylate oxo complexes.
(G) Substituted heteromonocycle, polymer with substituted alkanediol and diisocyanate substituted
carbomonocyle, alkylene glycol acrylate-blocked.
by EPA during this time period: The
EPA case number assigned to the test
information; the date the test
information was received by EPA, the
type of test information submitted, and
chemical substance identity.
TABLE III—TEST INFORMATION RECEIVED FROM 12/01/2018 TO 12/31/2018
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Case No.
Received date
Type of test information
Chemical substance
Fish Acute Toxicity (OECD 203) Invertebrate Acute Toxicity
(Fathead minnows), Algae Toxcitiy (Raphidocelis subcapitata).
Whole Body (Inhalation) 2 Generation Reproductive Toxicity
Study and Work Place Air Monitoring and Exposure Modeling
Study.
QSAR Assessment Report on Vinyl Laurate; Skin Sensitization:
Local Lymph Node Assay (OECD TG 429); Repeated Does
90-Day Oral Toxicity in Rodents (OECD TG 408); Repeated
Dose Toxicity and Repro/Devel Toxicity Screening (OECD TG
422); Chromosome Aberration Test (OECD TG 473); Gene
Mutation Assay (OECD TG 476); Micronucleus Test (OECD
TG 474); Prenatal Developmental Toxicity Study (OECD TG
414); Aquatic Toxicity—Daphnia (OECD TG 202); Aquatic
Toxicity—Daphnia Reproductive (OECD TG 211); Aquatic
Toxicity—Algal
Growth
(OECD
TG
201);
Ready
Biodegradability (OECD TG 301); Dermal Irritation/Corrosion
(OECD TG 404); Bacterial Reverse Mutation Assay—Ames
Test (OECD 471); Fish Acute Toxicity (OECD TG 203); Activated Sludge Test (OECD TG 209); Acute Oral Toxicity
(OECD TG 401); Acute Eye Irritation (OECD TG 405); Acute
Dermal Toxicity (OECD TG 402). Note: There are no additional processing and use requests beyond the original PMN,
except for allowing our site limited use as a monomer in polymer production. Added commentary on EPA Risk Assessment.
Routine/Annual Testing and Reporting: Certifications of Analysis
Routine/Annual Testing and Reporting: Certifications of Analysis
Routine/Annual Testing and Reporting: Certifications of Analysis
Routine/Annual Testing and Reporting: Certifications of Analysis
Routine/Annual Testing and Reporting: Certifications of Analysis
Routine/Annual Testing and Reporting: Certifications of Analysis
Routine/Annual Testing and Reporting: Certifications of Analysis
Routine/Annual Testing and Reporting: Certifications of Analysis
Routine/Annual Testing and Reporting: Certifications of Analysis
Routine/Annual Testing and Reporting: Certifications of Analysis
Routine/Annual Testing and Reporting: Certifications of Analysis
(G) Alkarylsulfonic acid, sodium
salts.
(G) Polyfluorohydrocarbon.
P–00–0281 ......................
12/4/2018
SN–17–0011 ....................
12/4/2018
P–87–1436 ......................
12/6/2018
P–11–0483
P–11–0484
P–11–0487
P–11–0527
P–11–0528
P–11–0529
P–11–0530
P–11–0532
P–11–0533
P–11–0534
P–11–0543
......................
......................
......................
......................
......................
......................
......................
......................
......................
......................
......................
12/7/2018
12/7/2018
12/7/2018
12/7/2018
12/7/2018
12/7/2018
12/7/2018
12/7/2018
12/7/2018
12/7/2018
12/7/2018
P–17–0115 ......................
12/11/2018
P–17–0337 ......................
12/12/2018
Skin Sensitization: Local Lymph Node Assay (OECD Test
Guideline 429).
Industrial Hygiene Monitoring Report ............................................
P–18–0382 ......................
12/10/2018
Consumer Exposure Data .............................................................
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(S) Dodecanoic acid, ethenyl
ester.
(G) Alkyl thiol.
(G) Alkyl sulfate salt.
(G) Alkyl polyamide.
(G) Substituted fluoroalkane.
(G) Fluorinated thiol.
(G) Fluorinated monomer.
(G) Fluoropolyacrylamide.
(G) Polyfluoroalkyl amine.
(G) Non-ionic fluorosurfactant.
(G) Anionic fluorosurfactant.
(G) Polyfluorinated alkyl quaternary amine chloride.
(G) Aminoalkyl alkoxysilane.
(S) Aluminum cobalt lithium
nickel oxide.
(G)
Xanthylium,
bis[dicarboxycyclic]
sulfonylaminoalkylcyclicamino-disulfosulfocyclic-,
inner
salt,
monocationic salt.
14372
Federal Register / Vol. 84, No. 69 / Wednesday, April 10, 2019 / Notices
If you are interested in information
that is not included in these tables, you
may contact EPA’s technical
information contact or general
information contact as described under
FOR FURTHER INFORMATION CONTACT to
access additional non-CBI information
that may be available.
Authority: 15 U.S.C. 2601 et seq.
Dated: March 7, 2019.
Pamela Myrick,
Director, Information Management Division,
Office of Pollution Prevention and Toxics.
[FR Doc. 2019–07094 Filed 4–9–19; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
[FRL–9991–78–OLEM]
Access to Confidential Business
Information by Eastern Research
Group (ERG)
Environmental Protection
Agency (EPA).
ACTION: Notice of access to data and
request for comments.
AGENCY:
The Environmental Protection
Agency (EPA) will authorize its
contractor, Eastern Research Group
(ERG) to access Confidential Business
Information (CBI) which has been
submitted to EPA under the authority of
all sections of the Resource
Conservation and Recovery Act (RCRA)
of 1976, as amended. EPA has issued
regulations that outline business
confidentiality provisions for the
Agency and require all EPA Offices that
receive information designated by the
submitter as CBI to abide by these
provisions.
SUMMARY:
Access to confidential data
submitted to EPA will occur no sooner
than April 22, 2019.
FOR FURTHER INFORMATION CONTACT:
LaShan Haynes, Document Control
Officer, Office of Resource Conservation
and Recovery, (5305P), U.S.
Environmental Protection Agency, 1200
Pennsylvania Avenue NW, Washington,
DC 20460, 703–605–0516.
SUPPLEMENTARY INFORMATION:
DATES:
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Access to Confidential Business
Information
Under EPA Contract EP–W–10–055,
entitled ‘‘Advancing Sustainable
Materials Management (SMM): Waste
Facts and Figures and Related Tasks,’’
the Eastern Research Group (ERG) will
assist the Office of Resource
Conservation and Recovery, Resource
Conservation and Sustainability
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Division in collecting and analyzing
municipal solid waste (MSW)
information. The contract addresses
MSW and other waste such as
construction and demolition debris,
however, the confidential business
information (CBI) only relates to the
MSW information collected and
analyzed in the contract. The contract
period is from March 2019 through
September 30, 2020. Some of the data
collected from industry are claimed by
industry to contain trade secrets or CBI.
In accordance with the provisions of 40
CFR part 2, subpart B, ORCR has
established policies and procedures for
handling information collected from
industry, under the authority of RCRA,
including RCRA Confidential Business
Information Security Manuals.
Eastern Research Group (ERG), shall
protect from unauthorized disclosure all
information designated as confidential
and shall abide by all RCRA CBI
requirements, including procedures
outlined in the RCRA CBI Security
Manual.
The U.S. Environmental Protection
Agency has issued regulations (40 CFR
part 2, subpart B) that outline business
confidentiality provisions for the
Agency and require all EPA Offices that
receive information designated by the
submitter as CBI to abide by these
provisions. ERG will be authorized to
have access to RCRA CBI under the EPA
‘‘Contractor Requirements for the
Control and Security of RCRA
Confidential Business Information
Security Manual.’’
EPA is issuing this notice to inform
all submitters of information under all
sections of RCRA that EPA will provide
Eastern Research Group access to the
CBI records located in the RCRA
Confidential Business Information
Center. Access to RCRA CBI under this
contract will take place at Eastern
Research Group and EPA Headquarters
only. Contractor personnel will be
required to sign non-disclosure
agreements and will be briefed on
appropriate security procedures before
they are permitted access to confidential
information.
Dated: March 22, 2019.
Barnes Johnson,
Director, Office of Resource Conservation &
Recovery.
[FR Doc. 2019–07113 Filed 4–9–19; 8:45 am]
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ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–OAR–2003–0033; FRL–9992–02–
OAR]
Proposed Information Collection
Request; Comment Request;
Information Collection Activities
Associated With EPA’s ENERGY
STAR® Product Labeling (Renewal)
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
The Environmental Protection
Agency (EPA) is planning to submit an
information collection request (ICR),
‘‘EPA’s ENERGY STAR Product
Labeling’’ (EPA ICR No. 2078.07, OMB
Control No. 2060–0528), to the Office of
Management and Budget (OMB) for
review and approval in accordance with
the Paperwork Reduction Act (44 U.S.C.
3501 et seq.). Before doing so, EPA is
soliciting public comments on specific
aspects of the proposed information
collection as described below. This is a
proposed extension of the ICR, which is
currently approved through September
30, 2019. An Agency may not conduct
or sponsor and a person is not required
to respond to a collection of information
unless it displays a currently valid OMB
control number.
DATES: Comments must be submitted on
or before June 10, 2019.
ADDRESSES: Submit your comments,
referencing Docket ID No. EPA–HQ–
OAR–2003–0033, online using
www.regulation.gov (our preferred
method), by email to a-and-r-Docket@
epa.gov, or by mail to: EPA Docket
Center, Environmental Protection
Agency, Mail Code 28221T, 1200
Pennsylvania Ave. NW, Washington, DC
20460.
EPA’s policy is that all comments
received will be included in the public
docket without change including any
personal information provided, unless
the comment includes profanity, threats,
information claimed to be Confidential
Business Information (CBI) or other
information whose disclosure is
restricted by statute.
FOR FURTHER INFORMATION CONTACT:
James Kwon, Climate Protection
Partnerships Division, Office of Air and
Radiation, Mailcode 6202A,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC
20460; telephone number: 202–564–
8538; fax number: 202–343–2200 email
address: kwon.james@epa.gov.
SUPPLEMENTARY INFORMATION:
Supporting documents which explain in
detail the information that the EPA will
SUMMARY:
E:\FR\FM\10APN1.SGM
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]]>Agencies
[Federal Register Volume 84, Number 69 (Wednesday, April 10, 2019)]
[Notices]
[Pages 14368-14372]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-07094]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2018-0411; FRL-9990-59]
Certain New Chemicals; Receipt and Status Information for
December 2018
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: EPA is required under the Toxic Substances Control Act (TSCA),
as amended by the Frank R. Lautenberg Chemical Safety for the 21st
Century Act, to make information publicly available and to publish
information in the Federal Register pertaining to submissions under
TSCA Section 5, including notice of receipt of a Premanufacture notice
(PMN), Significant New Use Notice (SNUN) or Microbial Commercial
Activity Notice (MCAN), including an amended notice or test
information; an exemption application (Biotech exemption); an
application for a test marketing exemption (TME), both pending and/or
concluded; a notice of commencement (NOC) of manufacture (including
import) for new chemical substances; and a periodic status report on
new chemical substances that are currently under EPA review or have
recently concluded review. This document covers the period from 12/01/
2018 to 12/31/2018.
DATES: Comments identified by the specific case number provided in this
document must be received on or before May 10, 2019.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2018-0411, and the specific case number for the
chemical substance related to your comment, by one of the following
methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
Mail: Document Control Office (7407M), Office of Pollution
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC 20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at https://www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: For technical information contact: Jim
Rahai, Information Management Division (7407M), Office of Pollution
Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number:
(202) 564-8593; 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. Executive Summary
A. What action is the Agency taking?
This document provides the receipt and status reports for the
period from 12/01/2018 to 12/31/2018. The Agency is providing notice of
receipt of PMNs, SNUNs and MCANs (including amended notices and test
information); an exemption application under 40 CFR part 725 (Biotech
exemption); TMEs, both pending and/or concluded; NOCs to manufacture a
new chemical substance; and a periodic status report on new chemical
substances that are currently under EPA review or have recently
concluded review.
EPA is also providing information on its website about cases
reviewed under the amended TSCA, including the section 5 PMN/SNUN/MCAN
and exemption notices received, the date of receipt, the final EPA
determination on the notice, and the effective date of EPA's
determination for PMN/SNUN/MCAN notices on its website at: https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/status-pre-manufacture-notices. This information is updated on a
weekly basis.
B. What is the Agency's authority for taking this action?
Under the TSCA, 15 U.S.C. 2601 et seq., a chemical substance may be
either an ``existing'' chemical substance or a ``new'' chemical
substance. Any chemical substance that is not on EPA's TSCA Inventory
of Chemical Substances (TSCA Inventory) is classified as a ``new
chemical substance,'' while a chemical substance that is listed on the
TSCA Inventory is classified as an ``existing chemical substance.''
(See TSCA section 3(11).) For more information about the TSCA Inventory
go to: https://www.epa.gov/tsca-inventory.
Any person who intends to manufacture (including import) a new
chemical substance for a non-exempt commercial purpose, or to
manufacture or process a chemical substance in a non-exempt manner for
a use that EPA has determined is a significant new use, is required by
TSCA section 5 to provide EPA with a PMN, MCAN or SNUN, as appropriate,
before initiating the activity. EPA will review the notice, make a risk
determination on the chemical substance or significant new use, and
take appropriate action as described in TSCA section 5(a)(3).
TSCA section 5(h)(1) authorizes EPA to allow persons, upon
application and under appropriate restrictions, to manufacture or
process a new chemical substance, or a chemical substance subject to a
significant new use rule (SNUR) issued under TSCA section 5(a)(2), for
``test marketing'' purposes, upon a showing that the manufacture,
processing, distribution in commerce, use, and disposal of the chemical
will not present an unreasonable risk of injury to health or the
environment. This is referred to as a test marketing exemption, or TME.
For more information about the requirements applicable to a new
chemical go to: https://www.epa.gov/oppt/newchems.
Under TSCA sections 5 and 8 and EPA regulations, EPA is required to
publish in the Federal Register certain information, including notice
of receipt of a PMN/SNUN/MCAN (including amended notices and test
information); an exemption application under 40 CFR part 725 (biotech
exemption); an application for a TME, both pending and concluded; NOCs
to manufacture a new chemical substance; and a periodic status report
on the new chemical substances that are currently under EPA review or
have recently concluded review.
C. Does this action apply to me?
This action provides information that is directed to the public in
general.
[[Page 14369]]
D. Does this action have any incremental economic impacts or paperwork
burdens?
No.
E. What should I consider as I prepare my comments for EPA?
1. Submitting confidential business information (CBI). Do not
submit this information to EPA through regulations.gov or email.
Clearly mark the part or all of the information that you claim to be
CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark
the outside of the disk or CD-ROM as CBI and then identify
electronically within the disk or CD-ROM the specific information that
is claimed as CBI. In addition to one complete version of the comment
that includes information claimed as CBI, a copy of the comment that
does not contain the information claimed as CBI must be submitted for
inclusion in the public docket. Information so marked will not be
disclosed except in accordance with procedures set forth in 40 CFR part
2.
2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at https://www.epa.gov/dockets/comments.html.
II. Status Reports
In the past, EPA has published individual notices reflecting the
status of TSCA section 5 filings received, pending or concluded. In
1995, the Agency modified its approach and streamlined the information
published in the Federal Register after providing notice of such
changes to the public and an opportunity to comment (See the Federal
Register of May 12, 1995 (60 FR 25798) (FRL-4942-7). Since the passage
of the Lautenberg amendments to TSCA in 2016, public interest in
information on the status of section 5 cases under EPA review and, in
particular, the final determination of such cases, has increased. In an
effort to be responsive to the regulated community, the users of this
information, and the general public, to comply with the requirements of
TSCA, to conserve EPA resources and to streamline the process and make
it more timely, EPA is providing information on its website about cases
reviewed under the amended TSCA, including the section 5 PMN/SNUN/MCAN
and exemption notices received, the date of receipt, the final EPA
determination on the notice, and the effective date of EPA's
determination for PMN/SNUN/MCAN notices on its website at: https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/status-pre-manufacture-notices. This information is updated on a
weekly basis.
III. Receipt Reports
For the PMN/SNUN/MCANs received by EPA during this period, Table I
provides the following information (to the extent that such information
is not subject to a CBI claim) on the notices received by EPA during
this period: The EPA case number assigned to the notice that indicates
whether the submission is an initial submission, or an amendment, a
notation of which version was received, the date the notice was
received by EPA, the submitting manufacturer (i.e., domestic producer
or importer), the potential uses identified by the manufacturer in the
notice, and the chemical substance identity.
As used in each of the tables in this unit, (S) indicates that the
information in the table is the specific information provided by the
submitter, and (G) indicates that this information in the table is
generic information because the specific information provided by the
submitter was claimed as CBI. Submissions which are initial submissions
will not have a letter following the case number. Submissions which are
amendments to previous submissions will have a case number followed by
the letter ``A'' (e.g., P-18-1234A). The version column designates
submissions in sequence as ``1'', ``2'', ``3'', etc. Note that in some
cases, an initial submission is not numbered as version 1; this is
because earlier versions were rejected as incomplete or invalid
submissions. Note also that future versions of the following tables may
adjust slightly as the Agency works to automate population of the data
in the tables.
Table I--PMN/SNUN/MCANs Received From 12/01/2018 to 12/31/2018
----------------------------------------------------------------------------------------------------------------
Chemical
Case No. Version Received date Manufacturer Use substance
----------------------------------------------------------------------------------------------------------------
J-19-0011..................... 1 12/23/2018 Danisco US, Inc.. (G) Production (G) Genetically
of a chemical modified
substance. microorganism
for the
production of a
chemical
substance.
P-19-0011..................... 4 12/20/2018 Shin etsu (G) Additive to (G)
Silicones of the EPDM rubber Polysulfides,
America. compounds. bis[3-
(trialkoxysilyl
)propyl].
P-19-0030..................... 2 12/18/2018 CBI.............. (G) Water (G)
Systems. Triethanolamine
modified
Phosphinicocarb
oxylates,
sodium salts.
P-19-0031..................... 2 12/28/2018 CBI.............. (S) Curing agent (G) Phenol, 4,4'-
for epoxy (1-
coating systems. methylethyliden
e)bis-, polymer
with
formaldehyde, 2-
(chloromethyl)o
xirane, alpha-
hydro-omega-
hydroxypoly(oxy-
1,2-
ethanediyl),
and polyamines.
P-19-0034..................... 1 12/6/2018 CBI.............. (G) Contained (G) Metal,
use as a bis(2,4-
component of pentanedionato-
tires. kO2,kO4)-, (T-
4)-.
P-19-0035..................... 3 12/10/2018 Firmenich, Inc... (G) Fragrance... (S) Acetamide, 2-
(4-
methylphenoxy)-
N-1H-pyrazol-3-
yl-N-(2-
thienylmethyl)-
.
P-19-0036..................... 1 12/10/2018 Ethox Chemicals, (S) As an (S) 1,4-
LLC. additive to Benzenedicarbox
polymers for ylic acid, 1,4-
improvement in bis(2-
gas barrier phenoxyethyl)
performance. ester.
[[Page 14370]]
P-19-0037..................... 1 12/11/2018 CBI.............. (G) Chemical (G) D-Glucaric
intermediate. acid, mixed
alkali metal
salt.
P-19-0038..................... 2 12/14/2018 Allan Chemical (S) Ink carrier (S) Fatty acids,
Corporation. for the ceramic coco, iso-Bu
industries. esters.
P-19-0040..................... 1 12/20/2018 CBI.............. (G) Intermediate (G) Alkyl
bis(dialkylamin
o alkyl) amide.
P-19-0041..................... 1 12/20/2018 CBI.............. (G) Oil water (G) Alkyl
separation. diester,
polymer with
(dialkylamino
alkyl) amine
and
bis(halogenated
alkyl) ether.
P-19-0042..................... 1 12/20/2018 CBI.............. (G) Oil water (G) Alkyl
separation. diester,
polymer with
(dialkylamino
alkyl) amine
and
bis(halogenated
alkyl) ether.
P-19-0043..................... 1 12/20/2018 CBI.............. (G) Oil water (G) Alkyl
separation. dicarboxylic
acid, polymer
with
(dialkylamino
alkyl) amine
and
bis(halogenated
alkyl) ether.
P-19-0044..................... 1 12/20/2018 CBI.............. (G) Oil water (G) Alkyl
separation. bis(dialkylamin
o alkyl) amide
polymer with
bis(halogenated
alkyl) ether.
P-19-0045..................... 1 12/21/2018 CBI.............. (G) Component of (G) Non-metal
textile coating. tetrakis
(hydroxyalkyl)-
, halide,
polymer with
amide oxidized.
SN-19-0002.................... 2 12/20/2018 Otsuka Chemical (G) Friction and (G) Potassium
America, Inc. wear stabilizer Titanate.
in certain
solid composite
articles.
----------------------------------------------------------------------------------------------------------------
In Table II. of this unit, EPA provides the following information
(to the extent that such information is not claimed as CBI) on the NOCs
received by EPA during this period: The EPA case number assigned to the
NOC including whether the submission was an initial or amended
submission, the date the NOC was received by EPA, the date of
commencement provided by the submitter in the NOC, a notation of the
type of amendment (e.g., amendment to generic name, specific name,
technical contact information, etc.) and chemical substance identity.
Table II--NOCs Received From 12/01/2018 to 12/31/2018
----------------------------------------------------------------------------------------------------------------
Commencement If amendment, type of
Case No. Received date date amendment Chemical substance
----------------------------------------------------------------------------------------------------------------
J-16-0021......................... 12/04/2018 12/04/2018 ..................... (G) Modified
trichoderma reesei.
J-18-0026......................... 12/21/2018 11/30/2018 ..................... (G) Biopolymer
producing modified
microorganism(s),
with chromosomally-
borne modifications.
J-18-0027......................... 12/21/2018 12/07/2018 ..................... (G) Biopolymer
producing modified
microorganism(s),
with chromosomally-
borne modifications.
J-18-0044......................... 12/21/2018 11/26/2018 ..................... (S) Saccharomyces
cerevisae NE095.
P-12-0168......................... 12/13/2018 12/07/2018 ..................... (S) 1,3,5-Triazine-
2,4,6-triamine, N-
(4,6-diamino-1,3,5-
triazin-2-yl)-.
P-16-0150......................... 12/20/2018 11/29/2018 ..................... (G)
Chlorofluorocarbon.
P-16-0173A........................ 12/20/2018 06/06/2016 Updated CBI (G) Aminoalkyl
substantiation for alaninate sodium
importing site and salt (1:1), polymer
update to generic with alkyldiol,
chemical name. dialkyl-alkanediol,
alkyldioic acid,
alkyldiol, polyol,
cycloaliphatic
diisocyanate,
polyalkylene glycol
mono-alkyl ether-
blocked.
P-16-0221......................... 12/14/2018 12/13/2018 ..................... (G) Fluorinated
organopolysilazane.
P-17-0330......................... 12/11/2018 12/03/2018 ..................... (G) Hexanedioic acid,
polymer with
trifuntional polyol,
1,1'-methylenebis
[isocyanatobenzene],
and 2,2'-oxybis
[ethanol].
P-17-0332......................... 12/14/2018 11/20/2018 ..................... (G) Benzenesulfonic
acid,
(alkenediyl)bis[[[(h
ydroxyalkyl)amino]-
(phenylamino)-
triazin-2-yl]amino]-
, N-(hydroxyalkyl)
derivs., salts.
P-18-0002......................... 12/05/2018 12/05/2018 ..................... (S) Phosphinic acid,
P,P-diethyl-, sodium
salt (1:1).
P-18-0147......................... 12/13/2018 11/29/2018 ..................... (G) Phenol, 4-ethenyl-
, 1-substituted,
polymer with 1-(1,1-
substituted)-4-
ethenylbenzene and
ethenylbenzene, 2,
2'-(1,2-
diazenediyl)bis[2-
substituted]-
initiated,
hydrolyzed.
[[Page 14371]]
P-18-0212......................... 12/11/2018 12/07/2018 ..................... (G) Substituted
carbomonocycle,
polymer with alkyl
alkenoate, alkenyl
substituted
carbomonocycle,
substituted
alkanediol,
heteropolycycle,
alkylene glycol and
alkenoic acid,
compd. with
alkylamino alkanol.
P-18-0261......................... 12/06/2018 12/05/2018 ..................... (G) Metal,
alkylcarboxylate oxo
complexes.
P-18-0279......................... 12/17/2018 12/14/2018 ..................... (G) Substituted
heteromonocycle,
polymer with
substituted
alkanediol and
diisocyanate
substituted
carbomonocyle,
alkylene glycol
acrylate-blocked.
----------------------------------------------------------------------------------------------------------------
In Table III. of this unit, EPA provides the following information
(to the extent such information is not subject to a CBI claim) on the
test information received by EPA during this time period: The EPA case
number assigned to the test information; the date the test information
was received by EPA, the type of test information submitted, and
chemical substance identity.
Table III--Test Information Received From 12/01/2018 to 12/31/2018
----------------------------------------------------------------------------------------------------------------
Case No. Received date Type of test information Chemical substance
----------------------------------------------------------------------------------------------------------------
P-00-0281............................... 12/4/2018 Fish Acute Toxicity (OECD (G) Alkarylsulfonic acid,
203) Invertebrate Acute sodium salts.
Toxicity (Fathead
minnows), Algae Toxcitiy
(Raphidocelis
subcapitata).
SN-17-0011.............................. 12/4/2018 Whole Body (Inhalation) 2 (G) Polyfluorohydrocarbon.
Generation Reproductive
Toxicity Study and Work
Place Air Monitoring and
Exposure Modeling Study.
P-87-1436............................... 12/6/2018 QSAR Assessment Report on (S) Dodecanoic acid,
Vinyl Laurate; Skin ethenyl ester.
Sensitization: Local
Lymph Node Assay (OECD TG
429); Repeated Does 90-
Day Oral Toxicity in
Rodents (OECD TG 408);
Repeated Dose Toxicity
and Repro/Devel Toxicity
Screening (OECD TG 422);
Chromosome Aberration
Test (OECD TG 473); Gene
Mutation Assay (OECD TG
476); Micronucleus Test
(OECD TG 474); Prenatal
Developmental Toxicity
Study (OECD TG 414);
Aquatic Toxicity--Daphnia
(OECD TG 202); Aquatic
Toxicity--Daphnia
Reproductive (OECD TG
211); Aquatic Toxicity--
Algal Growth (OECD TG
201); Ready
Biodegradability (OECD TG
301); Dermal Irritation/
Corrosion (OECD TG 404);
Bacterial Reverse
Mutation Assay--Ames Test
(OECD 471); Fish Acute
Toxicity (OECD TG 203);
Activated Sludge Test
(OECD TG 209); Acute Oral
Toxicity (OECD TG 401);
Acute Eye Irritation
(OECD TG 405); Acute
Dermal Toxicity (OECD TG
402). Note: There are no
additional processing and
use requests beyond the
original PMN, except for
allowing our site limited
use as a monomer in
polymer production. Added
commentary on EPA Risk
Assessment.
P-11-0483............................... 12/7/2018 Routine/Annual Testing and (G) Alkyl thiol.
Reporting: Certifications
of Analysis.
P-11-0484............................... 12/7/2018 Routine/Annual Testing and (G) Alkyl sulfate salt.
Reporting: Certifications
of Analysis.
P-11-0487............................... 12/7/2018 Routine/Annual Testing and (G) Alkyl polyamide.
Reporting: Certifications
of Analysis.
P-11-0527............................... 12/7/2018 Routine/Annual Testing and (G) Substituted
Reporting: Certifications fluoroalkane.
of Analysis.
P-11-0528............................... 12/7/2018 Routine/Annual Testing and (G) Fluorinated thiol.
Reporting: Certifications
of Analysis.
P-11-0529............................... 12/7/2018 Routine/Annual Testing and (G) Fluorinated monomer.
Reporting: Certifications
of Analysis.
P-11-0530............................... 12/7/2018 Routine/Annual Testing and (G) Fluoropolyacrylamide.
Reporting: Certifications
of Analysis.
P-11-0532............................... 12/7/2018 Routine/Annual Testing and (G) Polyfluoroalkyl amine.
Reporting: Certifications
of Analysis.
P-11-0533............................... 12/7/2018 Routine/Annual Testing and (G) Non-ionic
Reporting: Certifications fluorosurfactant.
of Analysis.
P-11-0534............................... 12/7/2018 Routine/Annual Testing and (G) Anionic
Reporting: Certifications fluorosurfactant.
of Analysis.
P-11-0543............................... 12/7/2018 Routine/Annual Testing and (G) Polyfluorinated alkyl
Reporting: Certifications quaternary amine
of Analysis. chloride.
P-17-0115............................... 12/11/2018 Skin Sensitization: Local (G) Aminoalkyl
Lymph Node Assay (OECD alkoxysilane.
Test Guideline 429).
P-17-0337............................... 12/12/2018 Industrial Hygiene (S) Aluminum cobalt
Monitoring Report. lithium nickel oxide.
P-18-0382............................... 12/10/2018 Consumer Exposure Data.... (G) Xanthylium,
bis[dicarboxycyclic]
sulfonylamino-
alkylcyclicamino-disulfo-
sulfocyclic-, inner salt,
monocationic salt.
----------------------------------------------------------------------------------------------------------------
[[Page 14372]]
If you are interested in information that is not included in these
tables, you may contact EPA's technical information contact or general
information contact as described under FOR FURTHER INFORMATION CONTACT
to access additional non-CBI information that may be available.
Authority: 15 U.S.C. 2601 et seq.
Dated: March 7, 2019.
Pamela Myrick,
Director, Information Management Division, Office of Pollution
Prevention and Toxics.
[FR Doc. 2019-07094 Filed 4-9-19; 8:45 am]
BILLING CODE 6560-50-P
