Certain New Chemical Substances; Receipt and Status Information for March 2018
Federal Register, Volume 83 Issue 125 (Thursday, June 28, 2018)
Federal Register Volume 83, Number 125 (Thursday, June 28, 2018)
Notices
Pages 30438-30442
From the Federal Register Online via the Government Publishing Office www.gpo.gov
FR Doc No: 2018-13944
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ENVIRONMENTAL PROTECTION AGENCY
EPA-HQ-OPPT-2017-0717; FRL-9979-14
Certain New Chemical Substances; Receipt and Status Information for March 2018
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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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
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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 March 1, 2018 to March 31, 2018.
DATES: Comments identified by the specific case number provided in this document must be received on or before July 30, 2018.
ADDRESSES: Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2017-0717, and the specific case number for the chemical substance related to your comment, by one of the following methods:
Federal eRulemaking Portal: http://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 http://www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: For technical information contact: Jim Rahai, Information Management Division (MC 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:
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Executive Summary
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What action is the Agency taking?
This document provides the receipt and status reports for the period from March 1, 2018 to March 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.
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What is the Agency's authority for taking this action?
Under the Toxic Substances Control Act (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: http://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.
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Does this action apply to me?
This action provides information that is directed to the public in general.
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Does this action have any incremental economic impacts or paperwork burdens?
No.
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What should I consider as I prepare my comments for EPA?
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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.
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Tips for preparing your comments. When preparing and submitting your comments, see the commenting tips at
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http://www.epa.gov/dockets/comments.html.
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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.
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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 version(s) 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 3/1/2018 to 3/31/2018
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Received
Case No. Version date Manufacturer Use Chemical substance
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P-16-0509A............ 10 3/2/2018 CBI.................. (G) For packaging (G) Modified
application. ethylene-vinyl
alcohol copolymer.
P-17-0235A............ 3 3/28/2018 CBI.................. (G) Anti-agglomerate. (G) Amidoamino
quaternary ammonium
salt.
P-17-0288A............ 7 3/27/2018 SK Chemicals America, (G) All-purpose (G)
Inc. packaging. Carbomonocyclicdica
rboxylic acid,
polymer with
cycloalkane(C=5~8)
alkanol,
alkanediol(C=1~5),
4-
(hydroxymethyl)cycl
ohexylmethyl 4-
(hydroxymethyl)cycl
ohexanecarboxylate,
substitutedalkanol(
C=1~5) and 4,4'-
oxybis(methylene)
bis
cyclohexanemethano
l.
P-17-0346A............ 5 03/19/2018 CBI.................. (G) Destructive use.. (G) Triarylalkyl
phosphonium halide
salt.
P-17-0398A............ 5 3/30/2018 Nexus Fuels.......... (G) Wax-Component of (G) Branched Cyclic
complex formulations and Linear
for various uses. Hydrocarbons from
Plastic
Depolymerization.
P-17-0399A............ 5 3/30/2018 Nexus Fuels.......... (G) Stock use........ (G) Alkane, Alkene,
Styrenic Compounds
Derived from
Plastic
Depolymerization.
P-18-0104............. 2 03/01/2018 CBI.................. (S) Halogen free (G) Heteroaromatic
flame retardant in substituted
thermoplastic alkanoic acid, 2,
polymers. 2-bis (1-oxo-2-
propen-1-
yl)oxymethyl-1,3-
propanediyl ester,
dioxide
homopolymer.
P-18-0117............. 2 03/02/2018 Mane USA............. (S) Fragrance to be (S)
put into a Fine Cyclopentaneacetoni
Fragrance, Personal trile, 2 , 4 , 4 -
Care Products such trimethyl -a-
as shampoo, body methylene-.
washes and lotions,
Consumer Care
Products such as
laundry detergents,
toilet bowl cleaners
and air fresheners.
P-18-0117A............ 3 03/12/2018 Mane USA............. (S) Fragrance to be (S)
put into a Fine Cyclopentaneacetoni
Fragrance, Personal trile, 2 , 4 , 4 -
Care Products such trimethyl -a-
as shampoo, body methylene-.
washes and lotions,
Consumer Care
Products such as
laundry detergents,
toilet bowl cleaners
and air fresheners.
P-18-0122............. 2 03/01/2018 CBI.................. (G) Paper additive... (G) Alkylamide,
polymer with
alkylamine,
formaldehyde, and
polycyanamide,
alkyl acid salt.
P-18-0123............. 1 03/02/2018 Duracell US Operation (S) Chemical (G) Alkali nickel
Inc. intermediate used in oxide.
the production of a
substance used in
battery.
P-18-0124............. 1 03/02/2018 Duracell US Operation (S) Used in the (G) Alkali nickel
Inc. production of oxide.
battery electrodes.
P-18-0125............. 1 03/07/2018 Noltex L.L.C......... (G) Reagent in (G)
coating material. Oxoalkylcarboxylic
acid, sodium salt.
P-18-0126............. 1 03/09/2018 Ishihara Corporation (S) Black pigment for (S) Calcium
(USA). architectural paint manganese titanium
(e.g. roof and walls oxide.
of buildings).
P-18-0127............. 1 03/12/2018 Takasago............. (S) Fragrance in fine (S) Heptane, 2-
fragrance (S) methoxy-2-methyl-.
Fragrance in
household products
(laundry detergent),
(S) Fragrance in
other consumer
products, (S)
Fragrance in shower
gels and shampoos.
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P-18-0128............. 1 03/12/2018 Cosun Biobased (G) Surface modifier. (S) Inulin, 2-
Products. hydroxy-3-
(trimethylammonio)p
ropyl ether,
chloride.
P-18-0082A............ 3 03/12/2018 Cytec Industries Inc. (S) Isolated (G) Aspartic acid,
intermediate used in tallow modified
the manufacture of a diester.
surface-active agent.
P-18-0097A............ 2 03/12/2018 Mane USA............. (S) Maderal is a (S) 1,3-Dioxane, 2-
fragrance that will (3,3-dimethyl-1-
be added to Personal cyclohexen-1-yl)-
Care Products, (S) 2,5,5-trimethly-.
Maderal is a
fragrance that will
be added to Consumer
Care Products, (S)
Maderal is a
fragrance that will
be added to Fine
Fragrances.
P-18-0129............. 1 03/13/2018 CBI.................. (G) Intermediate used (S) 2,2-dimethyl-3-
for chemical (3-
production. methylphenyl)propan
al,.
P-18-0129A............ 3 03/20/2018 CBI.................. (G) Intermediate used (S) Benzenepropanal,
for chemical alpha, alpha, 3-
production. trimethyl-.
P-18-0116A............ 2 03/13/2018 CBI.................. (G) Intermediate for (G) Fatty acid oil
industrial chemical. reaction product
with fatty acid
oil.
P-18-0130............. 1 03/15/2018 Allnex USA Inc....... (S) Adhesion promoter (G) Substituted
alkanediol, polymer
with
heteromonocycles,
alkenoate, metal
complexes.
P-18-0130A............ 3 03/30/2018 Allnex USA Inc....... (S) Adhesion promoter (G) Substituted
alkanediol, polymer
with
heteromonocycles,
alkenoate, metal
complexes.
P-18-0131............. 1 03/16/2018 Coim USA Inc......... (S) Polyester foam (G) Soybean oil,
applications. polymer with mixed
difunctional
glycols, glycerol,
melamine, phthalic
anhydride,
polyethylene
glycol, and
terephathalic acid.
P-18-0131A............ 2 03/27/2018 Coim USA Inc......... (S) Polyester foam (G) Soybean oil,
applications. polymer with mixed
difunctional
glycols, glycerol,
melamine, phthalic
anhydride,
polyethylene
glycol, and
terephathalic acid.
P-18-0132............. 1 03/20/2018 Cabot Corporation.... (S) Pigment (G) Substituted
dispersing aid. benzene, 4-methoxy-
2-nitro-5-2-(1e)-
1-(2-
methoxyphenyl)amino
carbonyl-2-
oxopropylidenehydr
azinyl-, sodium
salt (1:1).
P-18-0133............. 1 03/20/2018 CBI.................. (G) Component in (G) Polyol adduct of
hydraulic fracturing bisaldehyde.
fluids.
P-18-0134............. 1 03/21/2018 CBI.................. (G) Used for chemical (S) Benzene, 1-
production. (chloromethyl)-3-
methyl-.
P-18-0135............. 3 03/23/2018 CBI.................. (G) Ingredient for (S) 1,2-decanediol.
household products.
P-17-0393A............ 3 03/22/2018 Allnex USA Inc....... (G) Ultra violet (UV) (G) Alkanediamine,
Curable Coating dialkyl-, polymer
Resin. with a-hydro-w-(1-
oxo-2-propen-1-
yl)oxypoly(oxy-1,2-
ethanediyl) ether
with substituted
alkyl-
substitutedalkanedi
ol, reaction
products with alkyl-
alkanamine.
P-18-0137............. 1 03/23/2018 Wacker Chemical (S) For improved (G)
Corporation. water protection of Alkylsilsesquioxane
construction , ethoxy-
materials, like terminated.
cement fiber board.
P-18-0138............. 1 03/26/2018 CBI.................. (S) Compounding, (S) (G) Cyclo aromatic
Injection molding of dicarboxylic acid,
special applications. polymer with
hexacyclo aromatic
dicarboxylic acid,
alkanediamine and
dicycloalkanediamin
e.
P-18-0139............. 1 03/26/2018 Dayglo Color Corp.... (G) Pigment for Paint (G) Rare-earth
substituted
aluminum strontium
oxide, doped.
P-18-0140............. 2 03/27/2018 AdvanSix Inc......... (S) Export, (G) (G) Methyl modified
Agricultural lactam.
solvent, (G) Solvent
in coatings.
P-18-0141............. 2 03/27/2018 AdvanSix Inc......... (G) Solvent in (G) Ethyl modified
coatings, (S) lactam.
Export, (G)
Agricultural solvent.
P-18-0142............. 1 03/27/2018 Allnex USA Inc....... (S) Binder for (G) Alkanoic acid,
Topcoat coating. alkyl-, alkyl
ester, polymer with
substituted
alkenoates,
alkenoic acid,
alkyl peroxoate-
initiated.
P-18-0027A............ 3 03/29/2018 CBI.................. (G) The polymer will (G) 2-Propenoic
be used as an acid, 2-alkyl-, 2-
additive in coatings. (dialkylamino)alkyl
ester, polymer with
alpha-(2-alkyl-1-
oxo-2-alken-1-yl)-
omega-
methoxypoly(oxy-1,2-
alkanediyl).
P-18-0143............. 1 03/29/2018 Huntsman (S) Customers will (G) Tofa polymer
International LLC. further formulate with amines.
the product
containing the PMN
substance to make a
product that is used
in Industrial
applications as an
anti-corrosive
primer coating on
metal, (S) Customers
will further
formulate the
product containing
the PMN substance to
make a product that
is used as a primer
on concrete.
P-18-0144............. 1 03/29/2018 CBI.................. (G) Coating.......... (G) Formaldehyde,
polymer with an
amine and phenol.
P-18-0145............. 2 03/30/2018 CBI.................. (S) Plastic coatings, (G) Dialkanediol,
(S) Parquet polymer with 5-
coatings, (S) Metal isocyanato-1-
coatings, (S) Wood (isocyanatoalkyl)-
coatings, (S) 1,3,3-
Furniture coatings. trialkylcycloalkane
, bisn-3-
(trialkoxysilyl)alk
ylcarbamate(ester
).
P-18-0028A............ 2 3/30/2018 Nexus Fuels.......... (G) Blending stock... (G) Branched cyclic
and linear
hydrocarbons from
plastic
depolymerization.
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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
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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 3/1/2018 to 3/31/2018
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Commencement If amendment, type of
Case No. Received date date amendment Chemical substance
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P-00-0546A............. 03/23/2018 08/15/2000 Substantiated CBI............. (G) Alkyloxy-
hydroxypropyl,
trialkylamine,
ammonium chloride.
P-12-0084.............. 03/27/2018 02/15/2018 .............................. (G) Acrylic modified
polyolefin.
P-12-0289.............. 03/13/2018 01/26/2015 .............................. (G) Decanedioic acid,
polymer with
alcohol,
isooctadecanoate.
P-12-0351.............. 03/26/2018 03/22/2018 .............................. (G) Siloxanes and
silicones, alkyl,
alkyl propoxy ethyl,
methyl octyl, alkyl
polyfluorooctyl.
P-16-0278.............. 03/01/2018 02/16/2018 .............................. (G) 2-
(chloromethyl)oxiran
e and 4,4'-
methylenebisalkylph
enol polymer with
diphenol, reaction
products with 2-
propenoic acid, 2-
methyl-,
ethenylbenzene,
ethyl 2-propenoate
and 2-
(dimethylamino)ethan
ol.
P-16-0370.............. 03/20/2018 02/28/2018 .............................. (G) Methoxy-
terminated
polysiloxane.
P-17-0153.............. 03/19/2018 03/13/2018 .............................. (S) D-glucitol,1-
deoxy-1-
(dimethylamino)-.
P-17-0176.............. 03/22/2018 02/21/2018 .............................. (G) Carbonic acid,
alkyl
carbomonocyclic
ester,.
P-17-0283.............. 03/15/2018 02/15/2018 .............................. (G) Arenesulfonic
acid, alkyl
derivatives, metal
salts.
P-17-0337.............. 03/06/2018 03/06/2018 .............................. (S) Aluminum boron
cobalt lithium
nickel oxide.
P-17-0338.............. 03/06/2018 03/06/2018 .............................. (S) Aluminum boron
cobalt lithium
magnesium nickel
oxide.
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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 3/1/2018 to 3/31/2018
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Type of test Chemical
Case No. Received date information substance
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J-18-0001......... 3/6/2018 Data validating (G) Modified
microorganism Corynebacterium
inactivation. glutamicum.
P-16-0593......... 3/16/2018 Acute Inhalation (S) Carboxylic
Toxicity Study Acids, C6-18 and
of EP-730 in C5-15-di-,
Rats (OECD 403 polymers with
and OCSPP diethylene
870.1300). glycol,
glycerol,
sorbitol and
terephthalic
acid.
P-16-0225......... 3/19/2018 Direct Peptide (S) Isomer
Reactivity mixture of
Assay; Cyclohexanol, 4-
KeratinoSens ethylidene-2-
Study Report; propoxy- (CAS
DEREK Prediction 1631145-48-6)
Report; HRIPT (35-45%) and
Study Report.. Cyclohexanol, 5-
ethylidene-2-
propoxy (CAS
1631145-49-7)
(45-55%).
P-15-0353......... 3/21/2018 Acute Toxicity to (G) Chlorinated
Zebra Fish Complex Ester.
(Danio rerio) in
a 96-hour
Screening Test
(OECD 203);
Acute Toxicity
to Daphnia magna
in a 48-hour
Screening
Test(OECD 202);
and Anaerobic
Biodegradation
of Chlorinated
Fatty Acid
Methyl Esters in
Sediment (OECD
311).
P-18-0130......... 3/23/2018 Gel Permeation (G) Substituted
Chromatography alkanediol,
Analysis. polymer with
heteromonocycles
, alkenoate,
metal complexes.
P-12-0351......... 3/26/2018 Analytical (G) Siloxanes and
Report--Impuriti Silicones,
es. alkyl, alkyl
propoxy ethyl,
methyl octyl,
alkyl
polyfluorooctyl.
P-13-0658......... 3/26/2018 Repeated Dose 90- (G) Lithium Metal
day Inhalation Phosphate.
Toxicity Study
in Wistar Rats
Dust Aerosol
Exposure (OECD
413).
P-16-0543......... 3/27/2018 Exposure (G)
Monitoring Halogenophosphor
Report. ic acid metal
salt.
SN-15-0009........ 3/29/2018 Fish Early Life (G) Fatty Acid
Stage; amide.
Determination of
Effects in
Sediment on
Emergence of the
Midge,
Chironomus
riparius; and
Analytical
Method
Validation in
Sediment and
Surface Water
used in
Chironomid
Studies.
P-16-0577......... 3/29/2018 Two-Generation (G) Alkyl
Reproduction and Polyamine.
90-day Toxicity
Study in Rats by
Dietary
Administration.
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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: June 19, 2018.
Pamela Myrick,
Director, Information Management Division, Office of Pollution Prevention and Toxics.
FR Doc. 2018-13944 Filed 6-27-18; 8:45 am
BILLING CODE 6560-50-P
