[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]


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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.

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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 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: 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 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: 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.

[[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 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 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


