Certain New Chemicals; Receipt and Status Information for January 2019, 14365-14368 [2019-07082]
Download as PDF
<![CDATA[
Federal Register / Vol. 84, No. 69 / Wednesday, April 10, 2019 / Notices
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]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–OPPT–2019–0075; FRL–9991–20]
Certain New Chemicals; Receipt and
Status Information for January 2019
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 01/01/2019 to
01/31/2019.
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–2019–0075,
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
jbell on DSK30RV082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
20:36 Apr 09, 2019
Jkt 247001
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
01/01/2019 to 12/31/2019. 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.
B. 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
PO 00000
Frm 00027
Fmt 4703
Sfmt 4703
14365
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.
D. Does this action have any
incremental economic impacts or
paperwork burdens?
No.
E:\FR\FM\10APN1.SGM
10APN1
14366
Federal Register / Vol. 84, No. 69 / Wednesday, April 10, 2019 / Notices
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,
inparticular, 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.
III. Receipt Reports
For the PMN/SNUN/MCANs that
have passed an initial screening 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 screened 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 APPROVED* FROM 01/01/2019 TO 01/31/2019
jbell on DSK30RV082PROD with NOTICES
Case No.
Version
Received date
Manufacturer
Use
Chemical substance
(G) Biofuel producing Saccharomyces
cerevisiae modified, genetically stable.
(G) Biofuel producing Saccharomyces
cerevisiae modified, genetically stable.
(G) Biofuel producing Saccharomyces
cerevisiae modified, genetically stable.
(G) Biofuel producing Saccharomyces
cerevisiae modified, genetically stable.
(G) Phenol, 4,4’-(1-methylethylidene)bis-,
polymer with formaldehyde, 2(chloromethyl)oxirane, alpha-hydroomega-hydroxypoly(oxy-1,2-ethanediyl),
and polyamines.
(G) Carbonic dichloride, polymer with 4,4’(1-methylethylidene)bis[phenol] ester,
polymer with tetrol and polyether tetrol.
(G) Non-metal tetrakis (hydroxyalkyl)-, halide, polymer with amide oxidized.
(G) Aromatic polycarboxylic acid, alkyl (C8C10) esters.
(S) Propanoic acid, 3-hydroxy-2(hydroxymethyl)-2-methyl-, polymer with
5-amino-1,3,3trimethylcyclohexanemethanamine,
alpha-hydro-omega-hydroxypoly(oxy-1,4butanediyl), alpha-hydro-omegahydroxypoly[oxy(methyl-1,2-ethanediyl)],
5-isocyanato-1-(isocyanatomethyl)-1,3,3trimethylcyclohexane and 1,1’methylenebis[4-isocyanatobenzene].
J–19–0012 ..............
1
1/14/2019
CBI ...........................
(G) Ethanol Production ...............................
J–19–0013 ..............
1
1/14/2019
CBI ...........................
(G) Ethanol Production ...............................
J–19–0014 ..............
1
1/14/2019
CBI ...........................
(G) Ethanol Production ...............................
J–19–0015 ..............
1
1/14/2019
CBI ...........................
(G) Ethanol Production ...............................
P–19–0031 .............
2
12/28/2018
CBI ...........................
(S) Curing agent for epoxy coating systems
P–19–0032 .............
3
12/19/2018
Presidium USA, Inc.
P–19–0045 .............
1
12/21/2018
CBI ...........................
(G) Polyol used in the manufacture of articles made of a polyurethane thermoset
material.
(G) Component of textile coating ................
P–19–0046 .............
1
1/2/2019
P–19–0047 .............
1
1/2/2019
Kluber Lubrication
North America L.P.
US Polymers
Accurez LLC.
(G) Lubricating agent ..................................
(S) Binder for Thermoplastic Coatings .......
* The term ‘Approved’ indicates that a submission has passed a quick initial screen ensuring all required information and documents have been provided with the
submission prior to the start of the 90 day review period, and in no way reflects the final status of a complete submission review.
VerDate Sep<11>2014
20:36 Apr 09, 2019
Jkt 247001
PO 00000
Frm 00028
Fmt 4703
Sfmt 4703
E:\FR\FM\10APN1.SGM
10APN1
Federal Register / Vol. 84, No. 69 / Wednesday, April 10, 2019 / Notices
In Table II. 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
14367
type of test information submitted, and
chemical substance identity.
TABLE II—TEST INFORMATION RECEIVED FROM 01/01/2019 TO 01/31/2019
jbell on DSK30RV082PROD with NOTICES
Case No.
Received date
P–00–0281 ....
12/4/2018
SN–17–0011 ..
12/4/2018
P–87–1436 ....
12/6/2018
P–11–0483 ....
12/7/2018
P–11–0484 ....
12/7/2018
P–11–0487 ....
12/7/2018
P–11–0527 ....
12/7/2018
P–11–0528 ....
12/7/2018
P–11–0529 ....
12/7/2018
P–11–0530 ....
12/7/2018
P–11–0532 ....
12/7/2018
P–11–0533 ....
12/7/2018
P–11–0534 ....
12/7/2018
P–11–0543 ....
12/7/2018
P–18–0382 ....
12/10/2018
P–17–0115 ....
12/11/2018
P–17–0337 ....
12/12/2018
VerDate Sep<11>2014
20:36 Apr 09, 2019
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.
Consumer Exposure Data ............................................
Skin Sensitization: Local Lymph Node Assay (OECD
Test Guideline 429).
Industrial Hygiene Monitoring Report ...........................
Jkt 247001
PO 00000
Frm 00029
Fmt 4703
Sfmt 4703
(G) Alkarylsulfonic acid, sodium salts.
(G) Polyfluorohydrocarbon.
(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) Xanthylium, bis[dicarboxycyclic] sulfonylaminoalkylcyclicamino- disulfo-sulfocyclic-, inner salt,
monocationic salt.
(G) Aminoalkyl alkoxysilane.
(S) Aluminum cobalt lithium nickel oxide.
E:\FR\FM\10APN1.SGM
10APN1
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.
jbell on DSK30RV082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
20:36 Apr 09, 2019
Jkt 247001
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.
PO 00000
Frm 00030
Fmt 4703
Sfmt 4703
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.
E:\FR\FM\10APN1.SGM
10APN1
]]>Agencies
[Federal Register Volume 84, Number 69 (Wednesday, April 10, 2019)]
[Notices]
[Pages 14365-14368]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-07082]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2019-0075; FRL-9991-20]
Certain New Chemicals; Receipt and Status Information for January
2019
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 01/01/
2019 to 01/31/2019.
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-2019-0075, 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 01/01/2019 to 12/31/2019. 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 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: 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.
D. Does this action have any incremental economic impacts or paperwork
burdens?
No.
[[Page 14366]]
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,
inparticular, 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 that have passed an initial screening 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 screened 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 Approved* From 01/01/2019 to 01/31/2019
----------------------------------------------------------------------------------------------------------------
Case No. Version Received date Manufacturer Use Chemical substance
----------------------------------------------------------------------------------------------------------------
J-19-0012............ 1 1/14/2019 CBI............. (G) Ethanol (G) Biofuel producing
Production. Saccharomyces
cerevisiae modified,
genetically stable.
J-19-0013............ 1 1/14/2019 CBI............. (G) Ethanol (G) Biofuel producing
Production. Saccharomyces
cerevisiae modified,
genetically stable.
J-19-0014............ 1 1/14/2019 CBI............. (G) Ethanol (G) Biofuel producing
Production. Saccharomyces
cerevisiae modified,
genetically stable.
J-19-0015............ 1 1/14/2019 CBI............. (G) Ethanol (G) Biofuel producing
Production. Saccharomyces
cerevisiae modified,
genetically stable.
P-19-0031............ 2 12/28/2018 CBI............. (S) Curing agent for (G) Phenol, 4,4'-(1-
epoxy coating methylethylidene)bis-
systems. , polymer with
formaldehyde, 2-
(chloromethyl)oxiran
e, alpha-hydro-omega-
hydroxypoly(oxy-1,2-
ethanediyl), and
polyamines.
P-19-0032............ 3 12/19/2018 Presidium USA, (G) Polyol used in (G) Carbonic
Inc.. the manufacture of dichloride, polymer
articles made of a with 4,4'-(1-
polyurethane methylethylidene)bis
thermoset material. [phenol] ester,
polymer with tetrol
and polyether
tetrol.
P-19-0045............ 1 12/21/2018 CBI............. (G) Component of (G) Non-metal
textile coating. tetrakis
(hydroxyalkyl)-,
halide, polymer with
amide oxidized.
P-19-0046............ 1 1/2/2019 Kluber (G) Lubricating agent (G) Aromatic
Lubrication polycarboxylic acid,
North America alkyl (C8-C10)
L.P. esters.
P-19-0047............ 1 1/2/2019 US Polymers (S) Binder for (S) Propanoic acid, 3-
Accurez LLC. Thermoplastic hydroxy-2-
Coatings. (hydroxymethyl)-2-
methyl-, polymer
with 5-amino-1,3,3-
trimethylcyclohexane
methanamine, alpha-
hydro-omega-
hydroxypoly(oxy-1,4-
butanediyl), alpha-
hydro-omega-
hydroxypoly[oxy(meth
yl-1,2-ethanediyl)],
5-isocyanato-1-
(isocyanatomethyl)-
1,3,3-
trimethylcyclohexane
and 1,1'-
methylenebis[4-
isocyanatobenzene].
----------------------------------------------------------------------------------------------------------------
* The term `Approved' indicates that a submission has passed a quick initial screen ensuring all required
information and documents have been provided with the submission prior to the start of the 90 day review
period, and in no way reflects the final status of a complete submission review.
[[Page 14367]]
In Table II. 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 II--Test Information Received From 01/01/2019 to 01/31/2019
----------------------------------------------------------------------------------------------------------------
Case No. Received date Type of test information Chemical substance
----------------------------------------------------------------------------------------------------------------
P-00-0281................... 12/4/2018 Fish Acute Toxicity (OECD 203).. (G) Alkarylsulfonic acid, sodium
Invertebrate Acute Toxicity salts.
(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 Vinyl (S) Dodecanoic acid, ethenyl
Laurate; Skin Sensitization: ester.
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 fluoroalkane.
Reporting: Certifications 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 fluorosurfactant.
Reporting: Certifications of
Analysis.
P-11-0534................... 12/7/2018 Routine/Annual Testing and (G) Anionic fluorosurfactant.
Reporting: Certifications of
Analysis.
P-11-0543................... 12/7/2018 Routine/Annual Testing and (G) Polyfluorinated alkyl
Reporting: Certifications of quaternary amine chloride.
Analysis.
P-18-0382................... 12/10/2018 Consumer Exposure Data.......... (G) Xanthylium,
bis[dicarboxycyclic]
sulfonylamino-alkylcyclicamino-
disulfo-sulfocyclic-, inner
salt, monocationic salt.
P-17-0115................... 12/11/2018 Skin Sensitization: Local Lymph (G) Aminoalkyl alkoxysilane.
Node Assay (OECD Test Guideline
429).
P-17-0337................... 12/12/2018 Industrial Hygiene Monitoring (S) Aluminum cobalt lithium
Report. nickel oxide.
----------------------------------------------------------------------------------------------------------------
[[Page 14368]]
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
