[Federal Register Volume 84, Number 69 (Wednesday, April 10, 2019)]
[Notices]
[Pages 14360-14365]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-07078]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2018-0410; FRL-9990-58]
Certain New Chemicals; Receipt and Status Information for
November 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 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
[[Page 14361]]
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 11/01/2018 to 11/30/2018.
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-2018-0410, 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 (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 11/01/2018 to 11/30/2018. 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: 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.
C. Does this action apply to me?
This action provides information that is directed to the public in
general.
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 http://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
[[Page 14362]]
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 11/01/2018 to 11/30/2018
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Received
Case No. Version date Manufacturer Use Chemical substance
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J-19-0006................ 1 11/16/2018 Danisco US, Inc.... (G) Production of a (G) Genetically
chemical substance. modified
microorganism for
the production of
a chemical
substance.
J-19-0007................ 1 11/16/2018 Danisco US, Inc.... (G) Production of a (G) Genetically
chemical substance. modified
microorganism for
the production of
a chemical
substance.
J-19-0008................ 1 11/16/2018 Danisco US, Inc.... (G) Production of a (G) Genetically
chemical substance. modified
microorganism for
the production of
a chemical
substance.
J-19-0009................ 3 11/21/2018 CBI................ (G) Production of (G) Microorganism
basic nitrogen- producing basic
containing acid. nitrogen-
containing acid.
J-19-0010................ 3 11/21/2018 CBI................ (G) Production of (G) Microorganism
basic nitrogen- producing basic
containing acid. nitrogen-
containing acid.
P-18-0377................ 3 11/16/2018 CBI................ (G) microelectronic (G) N,N-Bis
use. (haloalkylsubstitu
ted) sulfamide.
P-18-0385................ 2 11/14/2018 Colonial Chemical, (S) Liquid Laundry. (S) D-
Inc. Glucopyranose,
oligomeric, Bu
glycosides,
polymers with
epichlorohydrin, 2-
hydroxy-3-
sulfopropyl
ethers, sodium
salts.
P-19-0001................ 2 11/1/2018 Burgess Pigment (G) Filler for (G) Aluminum
Company. plastic. silicate clay
treated with
siloxane (vinyl
functionality).
P-19-0012................ 4 11/8/2018 CBI................ (S) Resin component (G)
for the Benzenedicarboxyli
polyisocyanurate c acid, polymer
(S) Resin with
component in isobenzofurandione
specialty and oxybis
polyurethane kits [ethanol].
and systems for
aerospace and
military
applications.
P-19-0012................ 5 11/26/2018 CBI................ (S) Resin component (G)
for the Benzenedicarboxyli
polyisocyanurate. c acid, polymer
(S) Resin component with
in specialty isobenzofurandione
polyurethane kits and oxybis
and systems for [ethanol].
aerospace and
military
applications.
P-19-0013................ 2 11/15/2018 CBI................ (S) Surfactant for (G) Alkyl Cyclic
use in asphalt Amide.
emulsions.
P-19-0014................ 2 11/5/2018 CBI................ (S) Emulsifier for (G) Alkyl Cyclic
use in asphalt Amide Chloride.
applications.
P-19-0015................ 2 11/15/2018 CBI................ (S) Emulsifier for (G) Alkyl Cyclic
use in asphalt Amide.
applications.
P-19-0016................ 2 11/15/2018 CBI................ (S) Emulsifier for (G) Alkyl Cyclic
use in asphalt Amide Chloride.
applications.
P-19-0017................ 2 11/15/2018 CBI................ (S) Emulsifier for (G) Alkyl Amide
use in asphalt Alcohol.
applications.
P-19-0018................ 2 11/15/2018 CBI................ (S) Emulsifier for (G) Alkyl Amide
use in asphalt Alcohol Chloride.
applications.
P-19-0019................ 1 11/8/2018 CBI................ (G) Intermediate... (G) Haloalkane.
[[Page 14363]]
P-19-0020................ 1 11/8/2018 CBI................ (G) Lubricating oil (G) Alkylphenol,
additive. reaction products
with carbon
dioxide, distn.
residues from
manuf. of
alkylphenol
derivs. and
calcium
alkylphenol
derivs.
P-19-0021................ 1 11/9/2018 Nippon Kayaku (G) Pigment ink.... (G) Hydroxyalkyl
America, Inc. carboxylic acid,
polymer with
alkylamine,
alkylene
carbonate,
alkanediol,
isocyanate, compd.
with alkylamine.
P-19-0022................ 1 11/9/2018 Nippon Kayaku (G) Pigment ink.... (G) Hydroxyalkyl
America, Inc. carboxylic acid,
polymer with
alkylamine, alkyl
carbonate,
alkanediol,
isocyanate, compd.
with alkylamine.
P-19-0023................ 1 11/16/2018 Allnex USA, Inc.... (S) Powder coating (G) Substituted
resin for carbomonocyle,
industrial polymer with
application. substituted
carbomonocycles,
dialkyl-
alkanediol, alkyl-
hydroxyalkyl-
alkanediol and
alkanedioic acid.
P-19-0024................ 1 11/16/2018 Sales and (S) Hot Mix Asphalt (S) 1-
Distribution Application, (S) Octadecanaminium,
Services, Inc. Waterproofing N,N-dimethyl-N-[3-
Application, (S) (trimethoxysilyl)p
Asphalt Emulsion ropyl]-, chloride
Application. (1:1) , reaction
products with
water,
Trimethoxy(propyl)
silane,
Trimethoxy(methyl)
silane, Tetraethyl
orthosilicate and
ethane-1,2-diol.
P-19-0025................ 1 11/19/2018 Bercen, Inc........ (G) Hydrophobe (S) 11-Docosene.
formulation.
P-19-0026................ 1 11/27/2018 Allnex USA, Inc.... (S) The PMN (G) Alkanoic acid,
substance is an compds. with
isolated substituted
intermediate carbomonocycle-
incorporated as a dialkyl-
component in alkanediamine-
several allnex halosubstitued
coating resin heteromonocycle-
products used as polyalkylene
additives for glycol polymer-
corrosion dialkanolamine
protection. reaction products.
P-19-0027................ 1 11/28/2018 Allnex USA, Inc.... (S) The PMN (G) Substituted
substance is a Carbomoncycle,
component in polymer with
several allnex haloalkyl
coating resin substituted
products used as heteromonocycle,
additives for dialkyl-
corrosion alkanediamine and
protection. hydro-
hydroxypoly[oxy(al
kyl-alkanediyl)],
reaction products
with metal oxide
and
dialkanolamine,
acetates (salts).
P-19-0028................ 3 11/30/2018 CBI................ (G) Lubricating oil (G) Alkyl
additive. salicylate, metal
salts.
P-19-0029................ 1 11/29/2018 Cytec Industries, (G) Catalyst....... (S) Phosphonium,
Inc. tributylethyl-,
diethyl phosphate
(1:1).
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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 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 11/01/2018 to 11/30/2018
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Commencement If Amendment, type of
Case No. Received date date amendment Chemical substance
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P-08-0175.................. 11/06/2018 05/17/2008 ...................... (S) Hexanedioic acid,
polymer with 1,4-
butanediol, dimethyl
carbonate, 1,2-ethanediol,
1,6-hexanediol and 1,1'-
methylenebis[4-
isocyanatobenzene]*.
P-11-0069.................. 11/06/2018 06/06/2011 ...................... (G) Dispersible isocyanate
crosslinker.
P-13-0231.................. 11/08/2018 10/16/2018 ...................... (G) Alkylmethacrylate
polymer, with alkyl
acrylate, aromatic vinyl
monomer and alkyl
acrylate.
P-14-0510.................. 11/26/2018 05/15/2015 ...................... (S) Amides, vegetable-oil,
n,n-bis(hydroxyethyl),
reaction products with
maleic anhydride and
sodium sulfite (2:1).
P-16-0462A................. 11/02/2018 07/26/2018 To submit a revised (G) Ash (residues),
generic name. reaction products with
tetraethoxydioxa-
polyheteroatom-
disilaalkane.
P-16-0484.................. 11/06/2018 10/17/2018 ...................... (G) Phosphoric acid, metal
salt, cmpd. w/substituted
aromatic heterocycle.
P-17-0215.................. 11/21/2018 11/19/2018 ...................... (S) 2-butenedioic acid (2z)-
, 1,4-dibutyl ester,
polymer with 1-hexadecene
and 1-tetradecene.
[[Page 14364]]
P-17-0270.................. 11/14/2018 10/19/2018 ...................... (G) Alkyl perfluorinated
acryloyl ester.
P-17-0278.................. 11/06/2018 10/25/2018 ...................... (G) Fatty acid derived
imidazoline salts.
P-18-0070.................. 11/08/2018 11/05/2018 ...................... (G) Waste plastics,
polyester, depolymd. with
glycols, polymers with
dicarboxylic acids.
P-18-0102.................. 11/09/2018 11/08/2018 ...................... (G) Alkenoic acid, ester
with
[oxybis(alkylene)]bis[alky
l-substituted alkanediol],
polymer with
alkylcarbonate,
alkanediols, substituted
alkanoic acid and
isocyanate and alkyl
substituted
carbomonocycle, sodium
salt.
P-18-0134.................. 11/09/2018 11/07/2018 ...................... (S) Benzene, 1-
(chloromethyl)-3-methyl-.
P-18-0231.................. 11/11/2018 11/09/2018 ...................... (G) Alkanoic acid,
substituted alkyl-,
polymer with
isocyanatoalkane, alkyl
carbonate, alkanediol and
polyalkylene glycol ether
with alkyl(substituted
alkyl) alkanediol
alkenoate, glycerol
monoacrylate alkanoate-
blocked.
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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 11/01/2018 to 11/30/2018
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Type of test Chemical
Case No. Received date information substance
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P-18-0293............ 11/01/2018 In vitro (S)
mammalian propanedioic
chromosome acid, 2-
aberration test methylene-,
(OECD 473). 1,3-dihexyl
ester.
P-18-0294............ 11/01/2018 In vitro (S)
mammalian propanedioic
chromosome acid, 2-
aberration test methylene-,
(OECD 473). 1,3-
dicyclohexyl
ester.
P-11-0483............ 11/02/2018 Avian (G) alkyl
reproduction thiol.
test (OECD 206).
P-18-0128............ 11/02/2018 Acute dermal (S) inulin, 2-
irritation test hydroxy-3-
(OECD 404), (trimethylammo
Acute eye nio)propyl
irritation test ether,
(OECD 405), chloride.
Inherent
biodegradation
test (OECD
302C).
P-18-0350............ 11/05/2018 NMR test........ (G) aqueous
methacrylamido
modified
polysiloxane.
P-11-0557............ 11/05/2018 Annual import (G) 2-propenoic
volume acid, 2-methyl-
(Certificate of , 2-
Analysis). hydroxyethyl
ester,
telomers with
C18-26-alkyl
acrylate, 1-
dodecanethiol,
N-
(hydroxymethyl
)-2-methyl-2-
propenamide,
polyfluoroocty
l methacrylate
and vinylidene
chloride, 2,2'-
[1 ,2-
diazenediylbis
(1-
methylethylide
ne)bis[4,5-
dihydro-1 H-
imidazole]
hydrochloride
(1 :2)-
initiated.
P-12-0242............ 11/05/2018 Annual import (G) 2-propenoic
volume acid, 2-methyl-
(Certificate of , 2-
Analysis). hydroxyethyl
ester,
telomers with
C18-26-alkyl
acrylate, 1-
dodecanethiol,
N-
(hydroxymethyl
)-2-methyl-2-
propenamide,
polyfluoroocty
l
methacrylate,
2,2'-[1,2-
diazenediylbis
(1-
methylethylide
ne)]-bis[4,5-
dihydro-1H-
imidazole]
hydrochloride
(1:2)-
initiated.
P-16-0446............ 11/07/2018 Acute inhalation (G) fatty
irritation acids,
(OECD 403). reaction
products with
alkylamine,
polymers with
substituted
carbomonocycle
, substituted
alkylamines,
heteromonocycl
e and
substituted
alkanoate,
lactates
(salts).
SN-17-0011........... 11/08/2018 Reproductive and (G)
fertility polyfluorohydr
effects test ocarbon.
(OECD 416).
P-16-0543............ 11/14/2018 Exposure (G)
monitoring halogenophosph
report. oric acid
metal salt.
P-17-0253............ 11/15/2018 Tier 2 (G) oxirane, 2-
inhalation methyl-,
toxicology test polymer with
(OECD 412). oxirane,
methyl 2-
(substituted
carbomonocycle
isoquinolin-
2(3H)-yl)
propyl ether.
P-19-0019............ 11/20/2018 Bacterial (G) haloalkane.
reverse
mutation test
(OECD 471).
P-11-0063............ 11/23/2018 Anaerobic (G)
Transformation perfluoroalkyl
in Soil (OECD acryalte
307). copolymer.
P-14-0712............ 11/26/2018 PCCD/F EPA Test (G) plastics,
Method 8290A. wastes,
pyrolyzed, C5-
55 fraction.
P-17-0195............ 11/28/2018 Combined (G) 1,3-
Repeated Dose Propanediol, 2-
Toxicity Study methylene-
(OECD 422), substituted.
Unscheduled DNA
Synthesis (OECD
486).
P-17-0345............ 11/28/2018 Bovine Corneal (G)
Opacity and Polyurethane,
Permeability methacrylate
(BCOP) (OECD blocked.
437).
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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.
[[Page 14365]]
Dated: March 7, 2019.
Pamela Myrick,
Director, Information Management Division, Office of Pollution
Prevention and Toxics.
[FR Doc. 2019-07078 Filed 4-9-19; 8:45 am]
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