[Federal Register Volume 85, Number 241 (Tuesday, December 15, 2020)]
[Notices]
[Pages 81200-81205]
[FR Doc No: 2020-27540]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2020-0077; FRL-10016-83]

Certain New Chemicals; Receipt and Status Information for October
2020

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 10/01/2020 to 10/31/2020.

DATES: Comments identified by the specific case number provided in this
document must be received on or before January 14, 2021.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2020-0077, 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.
    Due to the public health concerns related to COVID-19, the EPA
Docket Center (EPA/DC) and Reading Room is closed to visitors with
limited exceptions. The staff continues to provide remote customer
service via email, phone, and webform. For the latest status
information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: For technical information contact: Jim
Rahai, Information Management Division (MC 7407M), Office of Pollution
Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number:
(202) 564-8593; email address<EMAIL_ADDRESS>    For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Executive Summary

A. What action is the Agency taking?

    This document provides the receipt and status reports for the
period from 10/01/2020 to 10/31/2020. 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 please 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 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 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 by EPA during this period: The EPA case number
assigned to the notice that indicates whether the submission is an
initial submission, or an amendment, a notation of which version was
received, the date the notice was received by EPA, the submitting
manufacturer (i.e., domestic producer or importer), the potential uses
identified by the manufacturer in the notice, and the chemical
substance identity.
    As used in each of the tables in this unit, (S) indicates that the
information in the table is the specific information provided by the
submitter, and (G) indicates that this information in the table is
generic information because the specific information provided by the
submitter was claimed as CBI. Submissions which are initial submissions
will not have a letter following the case number. Submissions which are
amendments to previous submissions will have a case number followed by
the letter ``A'' (e.g. P-18-1234A). The version column designates
submissions in sequence as ``1'', ``2'', ``3'', etc. Note that in some
cases, an initial submission is not numbered as version 1; this is
because earlier version(s) were rejected as incomplete or invalid
submissions. Note also that future versions of the following tables may
adjust slightly as the Agency works to automate population of the data
in the tables.

                        Table I--PMN/SNUN/MCANs Approved * From 10/01/2020 to 10/31/2020
----------------------------------------------------------------------------------------------------------------
                            Received
    Case No.      Version     date            Manufacturer                   Use             Chemical substance
----------------------------------------------------------------------------------------------------------------
P-17-0301A......        5  10/06/2020  CBI.......................  (G) Used as a surface   (G) Manganese
                                                                    drier in clear and      heterocyclic-amine
                                                                    pigmented coatings      carboxylate
                                                                    systems to replace      complexes.
                                                                    other primary driers,
                                                                    particularly cobalt.
P-18-0175A......        9  10/01/2020  Hexion Inc................  (S) Food can coating    (S) Formaldehyde,
                                                                    Non-food contact can    polymer with 4-(1,1-
                                                                    coating.                dimethylethyl)phenol
                                                                                and phenol, Bu
                                                                                ether.
P-18-0301A......        2  10/01/2020  CBI.......................  (G) Coating component.  (G) Alkanedioic acid,
                                                                                polymer with
                                                                                cycloalkyl
                                                                                dimethanol, alkyl
                                                                                and cycloalkyl
                                                                                diisocyanates,
                                                                                dimethyl-alkanediol,
                                                                                dihydroxyalkanoic
                                                                                acid
                                                                                methylenebis[isocyan
                                                                                atocyclohexane,
                                                                                hydroxyethyl
                                                                                acrylate- and
                                                                                polyalkyl glycol
                                                                                monoalkyl ether
                                                                                blocked.
P-18-0349A......        5  10/05/2020  Lanxess Solutions US, Inc.  (S) Two component       (S) Oxirane, 2-methyl-
                                                                    adhesives and           , polymer with
                                                                    protective coatings     oxirane, ether with
                                                                    for marine,             1,2,3-propanetriol
                                                                    infrastructure, etc.    (3:1), polymer with
                                                                    The urethane            2,4-diisocyanato-1-
                                                                    prepolymer is           methylbenzene,
                                                                    designed to react       branched 4-
                                                                    with epoxy materials    nonylphenol-blocked.
                                                                    to create a flexible
                                                                    coating or adhesive.
P-18-0383A......        4  10/01/2020  CBI.......................  (G) Coatings and inks   (G) Dialkyl-
                                                                    for commercial use.     alkanediamine,
                                                                                polymer with [(oxo-
                                                                                alkenyl)oxy]poly(oxy-
                                                                                alkanediyl)ether
                                                                                with
                                                                                bis(hydroxyalkyl)-
                                                                                alkanediol.
P-19-0011A......        7  10/16/2020  Shin etsu Silicones of      (G) Additive to the     (G) Polysulfides,
                                        America.                    EPDM rubber compounds.  bis[3-
                                                                                (trialkoxysilyl)prop
                                                                                yl].
P-19-0082A......        4  10/06/2020  Bedoukian Research Inc....  (S) Fragrance uses per  (S) Heptanal, 6-
                                                                    FFDCA: Fine             hydroxy-2,6-dimethyl-
                                                                    fragrance, creams,      .
                                                                    lotions, etc,
                                                                    Fragrance uses per
                                                                    TSCA: Scented papers,
                                                                    candles, detergents,
                                                                    cleaners, etc.
P-19-0167A......        5  10/09/2020  Santolubes Manufacturing,   (S) synthetic engine,   (S) Poly(oxy-1,4-
                                        LLC.                        gear and lubricating    butanediyl), alpha-
                                                                    oils and greases.       hydro-omega-hydroxy-
                                                                                , hexanoate.
P-20-0001A......        5  10/09/2020  Santolubes Manufacturing,   (S) Synthetic engine,   (S) Poly(oxy-1,4-
                                        LLC.                        gear & lubricating      butanediyl), alpha-
                                                                    oils & greases.         hydro-w-hydroxy-,
                                                                                nonanoate.
P-20-0010A......       10  10/14/2020  CBI.......................  (G) Polymerization      (G) Carboxylic acid,
                                                                    auxiliary.              reaction products
                                                                                with metal
                                                                                hydroxide, inorganic
                                                                                dioxide and metal.
P-20-0014A......        2  10/06/2020  McTron Technologies.......  (G) Water resistant     (G) Sugars, polymer
                                                                    resin additive, Heat    with alkanetriamine.
                                                                    resistant binder
                                                                    additive.
P-20-0046A......        5  10/07/2020  CBI.......................  (G) Catalyst..........  (G) Reaction products
                                                                                of alkyl-terminated
                                                                                alkylalumuminoxanes
                                                                                and
                                                                                {[(pentaalkylphenyl-
                                                                                (pentaalkylphenyl)am
                                                                                ino)alkyl]alkanediam
                                                                                inato{time} bis(aral
                                                                                kyl) transition
                                                                                metal coordination
                                                                                compound.
P-20-0046A......        6  10/27/2020  CBI.......................  (G) Catalyst..........  (G) Reaction products
                                                                                of alkyl-terminated
                                                                                alkylalumuminoxanes
                                                                                and
                                                                                {[(pentaalkylphenyl-
                                                                                (pentaalkylphenyl)am
                                                                                ino)alkyl]alkanediam
                                                                                inato{time} bis(aral
                                                                                kyl) transition
                                                                                metal coordination
                                                                                compound.
P-20-0048A......        5  10/07/2020  CBI.......................  (G) Catalyst..........  (G) Reaction products
                                                                                of alkyl-terminated
                                                                                alkylaluminoxanes
                                                                                and
                                                                                dihalogeno(alkylcycl
                                                                                opentadienyl)(tetraa
                                                                                lkylcyclopentadienyl
                                                                                )transition metal
                                                                                coordination
                                                                                compound.

P-20-0048A......        6  10/27/2020  CBI.......................  (G) Catalyst..........  (G) Reaction products
                                                                                of alkyl-terminated
                                                                                alkylaluminoxanes
                                                                                and
                                                                                dihalogeno(alkylcycl
                                                                                opentadienyl)(tetraa
                                                                                lkylcyclopentadienyl
                                                                                )transition metal
                                                                                coordination
                                                                                compound.
P-20-0049A......        5  10/07/2020  CBI.......................  (G) Catalyst..........  (G) Reaction products
                                                                                of alkyl-
                                                                                aluminoxanes and
                                                                                bis(alkylcyclodialky
                                                                                lene)dihalogenozirco
                                                                                nium.
P-20-0049A......        6  10/27/2020  CBI.......................  (G) Catalyst..........  (G) Reaction products
                                                                                of alkyl-
                                                                                aluminoxanes and
                                                                                bis(alkylcyclodialky
                                                                                lene)dihalogenozirco
                                                                                nium.
P-20-0061A......        4  10/13/2020  Allnex USA Inc............  (S) Coating resin       (G) Formaldehyde,
                                                                    crosslinking agent.     polymer with
                                                                                alkylphenols, alkyl
                                                                                ether.
P-20-0085A......        7  09/30/2020  Luna Innovations            (S) Fluid resistant     (G)
                                        Incorporated.               coatings.               Bis(triethoxysilylpr
                                                                                opyl carbamate)
                                                                                perfluoropolyether.
P-20-0098A......        4  10/21/2020  CBI.......................  (S) property modifier   (G) Calcium
                                                                    for polymers.           cycloalkylcarboxylat
                                                                                e.
P-20-0102A......        3  10/01/2020  Novihum Technologies, Inc.  (S) Fertilizer/Soil     (S) Chemical Abstract
                                                                    amendment.              (CA) index name:
                                                                                Coal, brown,
                                                                                ammoxidized.
P-20-0102A......        4  10/08/2020  Novihum Technologies, Inc.  (S) Fertilizer/Soil     (S) Chemical Abstract
                                                                    amendment.              (CA) index name:
                                                                                Coal, brown,
                                                                                ammoxidized.
P-20-0118A......        3  10/26/2020  CBI.......................  (G) Additive in         (S) Pyridine, 4-
                                                                    household consumer      methyl-2-pentyl-
                                                                    products..
P-20-0138.......        3  10/14/2020  Gurit (USA) Inc...........  (S) The substance is    (G) Alkane diglycidy
                                                                    part of a mixture       ether, polymer with
                                                                    with other amines to    alkyl-cycloalkane
                                                                    act as a curative for   diamines.
                                                                    a 2-part epoxy
                                                                    adhesive formulation.
                                                                    The new substance
                                                                    will be used within
                                                                    an adhesive
                                                                    formulation for use
                                                                    within an industrial
                                                                    setting primarily but
                                                                    not limited to
                                                                    industries such as
                                                                    marine, automotive
                                                                    and wind energy. The
                                                                    adhesive is ``cured''
                                                                    at either ambient
                                                                    conditions or using
                                                                    heat and a chemical
                                                                    reaction occurs
                                                                    forming a solid
                                                                    composite structure.
P-20-0143A......        3  10/22/2020  CBI.......................  (S) Binder for          (S)
                                                                    Thermoplastic           Cyclohexanemethanami
                                                                    Coatings, Binder or     ne, 5-amino-1,3,3-
                                                                    Ink/Adhesive.           trimethyl-, polymer
                                                                                with a-hydro-w-
                                                                                hydroxypoly(oxy-1,4-
                                                                                butanediyl), 5-
                                                                                isocyanato-1-
                                                                                (isocyanatomethyl)-
                                                                                1,3,3-
                                                                                trimethylcyclohexane
                                                                                and 1,1-
                                                                                methylenebis[4-
                                                                                isocyanatobenzene].
P-20-0167A......        3  10/22/2020  W.R. Grace & CO.--Conn....  (G) Catalyst..........  (G) Phenylene, alkyl
                                                                                and
                                                                                polycarbomonocycle
                                                                                substituted, 1,2-
                                                                                dicarboxylate.
P-20-0174A......        4  10/16/2020  P2 Science, Inc...........  (S) For use in          (S) 6-Octen-1-ol, 3,7-
                                                                    consumer products, as   dimethyl-,
                                                                    well as direct          homopolymer,
                                                                    addition to consumer    monoacetate.
                                                                    products. Specific
                                                                    functions would be as
                                                                    solubilizer, rheology
                                                                    modifier and
                                                                    fragrance oil.
P-20-0184A......        2  10/16/2020  P2 Science, Inc...........  (S) For use in          (S) 6-Octen-1-ol, 3,7-
                                                                    fragrances for          dimethyl-,
                                                                    consumer products, as   homopolymer.
                                                                    well as direct
                                                                    addition to consumer
                                                                    products. Specific
                                                                    functions would be as
                                                                    solubilizer, rheology
                                                                    modifier and
                                                                    fragrance oil.
P-20-0185.......        3  10/08/2020  Designer Molecules, Inc...  (G) Dielectric film     (S) Amines, C36-
                                                                    forming material for    alkylenedi-,
                                                                    use in                  polymers with
                                                                    microelectronic         bicyclo[2.2.1]heptan
                                                                    assembly applications.  edimethanamine,
                                                                                [5,5'-
                                                                                biisobenzofuran]-
                                                                                1,1',3,3'-tetrone
                                                                                and 3a,4,5,7a-
                                                                                tetrahydro-7-methyl-
                                                                                5-(tetrahydro-2,5-
                                                                                dioxo-3-furanyl)-1,3-
                                                                                isobenzofurandione,
                                                                                maleated.
P-21-0001.......        1  10/01/2020  CBI.......................  (G) Flame retardant...  (S) Phosphinic acid,
                                                                                aluminum salt (3:1).
P-21-0002.......        2  10/08/2020  CBI.......................  (G) Polymer in          (G) Octadecanoic
                                                                    coatings and ink.       acid, 12-hydroxy-,
                                                                                polymer with
                                                                                aziridine, 2-
                                                                                oxepanone and
                                                                                tetrahydro-2H-pyran-
                                                                                2-one, reaction
                                                                                products with
                                                                                disubstituted
                                                                                heteropolycycle.
P-21-0006.......        1  10/21/2020  CBI.......................  (G) The PMN Substance   (G) Naphthalene
                                                                    is used in froth        derivative.
                                                                    flotation to treat
                                                                    rare earth minerals
                                                                    and to remove
                                                                    deleterious
                                                                    substances.
SN-19-0002A.....        6  10/14/2020  CBI.......................  (G) Friction and wear   (G) Potassium
                                                                    stabilizer in certain   Titanate.
                                                                    solid composite
                                                                    articles.
----------------------------------------------------------------------------------------------------------------
* 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.

    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
that have passed an initial screening 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 Approved * From 10/01/2020 to 10/31/2020
----------------------------------------------------------------------------------------------------------------
                               Received     Commencement     If amendment, type of
          Case No.               date           date               amendment              Chemical substance
----------------------------------------------------------------------------------------------------------------
P-16-0449...................  10/01/2020        09/28/2020  N......................  (S) 2,7-decadienal, (2e,7z)-
                                                                                .
P-16-0539...................  10/07/2020        09/17/2020  N......................  (G) Organic sulfonate
                                                                                compound.
P-18-0234A..................  10/20/2020        12/09/2019  CBI Substantiation       (G) Alkenoic acid, reaction
                                                             provided.                products with bis
                                                                                substituted alkane and
                                                                                ether polyol.
P-18-0310...................  10/20/2020        10/12/2020  N......................  (S) Benzenepropanoic acid,
                                                                                3-(2h-benzotriazol-2-yl)-5-
                                                                                (1,1-dimethylethyl)-4-
                                                                                hydroxy-, 2,2-
                                                                                bis(hydroxymethyl)butyl
                                                                                ester.
P-18-0359...................  10/20/2020        10/14/2020  N......................  (S) Ethene, 1-
                                                                                [difluoro(trifluoromethoxy
                                                                                )methoxy]-1,2,2-trifluoro-
                                                                                , polymer with 1,1-
                                                                                difluoroethene.
P-18-0376...................  10/26/2020        10/15/2020  N......................  (G) Thiosulfuric acid,
                                                                                aminoalkyl ester.
P-18-0382...................  10/20/2020        10/06/2020  N......................  (G) Xanthylium,
                                                                                bis[dicarboxycyclic]sulfon
                                                                                ylamino-alkylcyclicamino-
                                                                                disulfo-sulfocyclic-,
                                                                                inner salt, monocationic
                                                                                salt.
P-18-0393...................  10/23/2020        10/22/2020  N......................  (G) Alkenoic acid, alkyl,
                                                                                alkyl ester, polymer with
                                                                                alkyl propenoate, vinyl
                                                                                carbomonocyle, substituted
                                                                                alkyl propenoate, alkyl 2-
                                                                                alkyl 2-propenoate,
                                                                                alkanediol mono(2-alkyl-2-
                                                                                propenoate) and
                                                                                bicarbomonocylo alkyl 2-
                                                                                alkyl-2-alkenoate,
                                                                                tertiary alkyl substituted
                                                                                alkane peroxoate
                                                                                initiated.
P-18-0405...................  09/29/2020        09/27/2020  N......................  (S) Phenol, 4,4'-(1-
                                                                                methylethylidene)bis-,
                                                                                polymer with 3,6,9,12-
                                                                                tetraoxatetradeca-1,13-
                                                                                diene, glycidyl ether.
P-20-0011...................  10/20/2020        10/12/2020  N......................  (G) Tetraoxaspiro[5.5]alkyl-
                                                                                3,9-diylbis(alkyl-2,1-
                                                                                diyl) bis(2-cyano-3-(3,4-
                                                                                dimethoxyphenyl)acrylate).
P-20-0035...................  10/20/2020        10/06/2020  N......................  (G) Substituted aromatic,
                                                                                3,3'-[[6-[(substituted
                                                                                alkyl amino)]-1,3,5-
                                                                                triazine-2,4-
                                                                                diyl]bis[imino[2-
                                                                                (substituted)-5-
                                                                                [substituted alkoxy]-4,1-
                                                                                phenylene]-2,1-
                                                                                diazenediyl]]bis[substitut
                                                                                ed, sodium salt].
P-20-0061...................  10/27/2020        10/25/2020  N......................  (G) Formaldehyde, polymer
                                                                                with alkylphenols, alkyl
                                                                                ether.
P-20-0066...................  10/29/2020        10/29/2020  N......................  (G) 2-propenoic acid, 2-
                                                                                hydroxyethyl ester,
                                                                                reaction products with
                                                                                dialkyl hydrogen
                                                                                heterosubstituted
                                                                                phosphate and dimethyl
                                                                                phosphonate.
----------------------------------------------------------------------------------------------------------------
* 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.

    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 that has been received 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 10/01/2020 to 10/31/2020
----------------------------------------------------------------------------------------------------------------
            Case No.              Received date      Type of test information           Chemical substance
----------------------------------------------------------------------------------------------------------------
P-14-0712......................      10/02/2020  Quarterly PCDD/F Test of PMN     (G) Plastics, wastes,
                                                  Substance using EPA Test         pyrolyzed, bulk pyrolysate.
                                                  Method 8290A.
P-16-0543......................      10/13/2020  Exposure Monitoring Report.....  (G) Halogenophosphoric acid
                                                                                metal salt.
P-17-0345......................      10/08/2020  Physical Chemical Properties     (G) Polyurethane, methacrylate
                                                  Report (OECD Test Guideline      blocked.
                                                  104 and 122; EC Methods A.9,
                                                  A.14, A.15 and A.21), Acute
                                                  Dermal Irritation (OECD Test
                                                  Guideline 404), Acute Eye
                                                  Irritation (OECD Test
                                                  Guideline 405), Skin
                                                  Sensitization, LLNA (OECD Test
                                                  Guideline 422B), Acute Oral
                                                  Toxicity (OECD Test Guideline
                                                  423), and Bacterial Reverse
                                                  Mutation Assay (OECD Test
                                                  Guideline 471).
P-18-0154......................      10/12/2020  Algal Toxicity (OECD Test        (G) Isocyanic acid,
                                                  Guideline 201), Acute Oral       polyalkylenepolycycloalkylene
                                                  Toxicity Study in Rats (OECD     ester, 2-alkoxy alkanol and 1-
                                                  Test guideline 423), and Water   alkoxy alkanol and alkylene
                                                  Extractability Study. All test   diol blocked.
                                                  submitted on analog data.
P-20-0066......................      09/29/2020  Reproductive/development         (G) 2-propenoic acid, 2-
                                                  Toxicity Screening Study in      hydroxyethyl ester, reaction
                                                  the Han Wistar Rat by Oral       products with dialkyl
                                                  Gavage Administration.           hydrogen heterosubstituted
                                                                                phosphate and dimethyl
                                                                                phosphonate.
P-20-0162......................      10/07/2020  Acute Oral Toxicity Study in     (G) Substituted, triaryl-, 3-
                                                  Rats (OCED Test Guideline 420)   substituted-2-substituted
                                                  and Bacterial Reverse Mutation   alkyl tricycloalkane-1-
                                                  Test (Ames Assay, OECD Test      carboxylate (1:1).
                                                  Guideline 471).
P-20-0162......................      10/07/2020  Acute Oral Toxicity Study in     (G) Sulfonium, triaryl-, 3,3,3-
                                                  Rats (OCED Test Guideline 420)   trihalo-2-sulfoalkyl
                                                  and Bacterial Reverse Mutation   polycycloalkane-1-carboxylate
                                                  Test (Ames Assay, OECD Test      (1:1).
                                                  Guideline 471).
----------------------------------------------------------------------------------------------------------------

    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: November 12, 2020.
Pamela Myrick,
Director, Information Management Division, Office of Pollution
Prevention and Toxics.
[FR Doc. 2020-27540 Filed 12-14-20; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 80, Number 144 (Tuesday, July 28, 2015)]
[Notices]
[Pages 44971-44973]
[FR Doc No: 2015-18410]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0386]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Registration and
Product Listing for Owners and Operators of Domestic Tobacco Product
Establishments and Listing of Ingredients in Tobacco Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by August
27, 2015.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0650.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Registration and Product Listing for Owners and Operators of Domestic
Tobacco Product Establishments and Listing of Ingredients in Tobacco
Products--OMB Control Number 0910-0650--Extension

    On June 22, 2009, the President signed the Tobacco Control Act
(Pub. L. 111-31) into law. The Tobacco Control Act amended the Federal
Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 301 et seq.) by,
among other things, adding a chapter granting FDA important authority
to regulate the manufacture, marketing, and distribution of tobacco
products to protect the public health generally and to reduce tobacco
use by minors.
    Section 905(b) of the FD&C Act (21 U.S.C. 387e(b)), as amended by
the Tobacco Control Act, requires that ``every person who owns or
operates any establishment in any State engaged in the manufacture,
preparation, compounding, or processing of a tobacco product or tobacco
products . . .'' register with FDA the name, places of business, and
all establishments owned or operated by that person. Every person must
register by December 31 of each year. Section 905(c) of the FD&C Act
requires that first-time persons ``engaging in the manufacture,
preparation, compounding, or processing of a tobacco product or tobacco
products shall register with the Secretary the name, places of
business, and all such establishments of that person.'' Section 905(d)
states that persons required to register under section 905(b) or (c)
shall register any additional establishment that they own or operate in
any State which begins the manufacture, preparation, compounding, or
processing of a tobacco product or tobacco products. Section 905(h)

addresses foreign establishment registration requirements, which will
go into effect when regulations are issued by the Secretary. Section
905(i)(1) of the FD&C Act, as amended by the Tobacco Control Act,
requires that all registrants ``shall, at the time of registration
under any such subsection, file with [FDA] a list of all tobacco
products which are being manufactured, prepared, compounded, or
processed by that person for commercial distribution,'' along with
certain accompanying consumer information, such as all labeling and a
representative sampling of advertisements. Section 904(a)(1) of the
FD&C Act (21 U.S.C. 387d(a)(1)), as amended by the Tobacco Control Act,
requires each tobacco product manufacturer or importer, or agent
thereof, to submit ``a listing of all ingredients, including tobacco,
substances, compounds, and additives that are * * * added by the
manufacturer to the tobacco, paper, filter, or other part of each
tobacco product by brand or by quantity in each brand and subbrand.''
Since the Tobacco Control Act was enacted on June 22, 2009, the
information required under section 904(a)(1) must be submitted to FDA
by December 22, 2009, and include the ingredients added as of the date
of submission. Section 904(c) of the FD&C Act also requires submission
of information whenever additives, or the quantities of additives, are
changed.
    FDA issued guidance documents on both: (1) Registration and Product
Listing for Owners and Operators of Domestic Tobacco Product
Establishments and (2) listing of Ingredients in Tobacco Products to
assist persons making such submissions to FDA under the Tobacco Control
Act. While electronic submission of registration and product listing
information and ingredient listing information are not required, FDA is
strongly encouraging electronic submission to facilitate efficiency and
timeliness of data management and collection. To that end, FDA designed
electronic submission applications to streamline the data entry process
for registration and product listing and for ingredient listing. These
tools allow for importation of large quantities of structured data,
attachment of files (e.g., in portable document format (PDFs) and
certain media files), and automatic acknowledgement of FDA's receipt of
submissions.
    FDA also developed paper forms (Form FDA 3741--Registration and
Listing for Owners and Operators of Domestic Tobacco Product
Establishments, and Form FDA 3742--Listing of Ingredients in Tobacco
Products) as an alternative submission tool. Both the electronic
submission application and the paper forms can be accessed at http://www.fda.gov/tobacco.
    In the Federal Register of April 21, 2015 (80 FR 22202), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as
follows:

                                                       Table 1--Estimated Annual Reporting Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Total
                                                   Number of       Number of     Total annual                                     Total    operating and
         FDA Form/activity/TCA section            respondents    responses per     responses          Hours per  response         hours     maintenance
                                                                  respondent                                                                   costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Tobacco Product Establishment Initial                      135               1             135  2..............................      270           $0.66
 Registration and Listing; Form FDA 3741
 Registration and Product Listing for Owners
 and Operators of Domestic Establishments
 (Electronic and Paper submissions); Section
 905(b), (c), (d), (h), or (i).
Tobacco Product Establishment Renewal                      135               1             135  0.20 (12 minutes)..............       27            0.66
 Registration and Listing; Form FDA 3741
 Registration and Product Listing for Owners
 and Operators of Domestic Establishments
 (Electronic and Paper submissions); Section
 905(b), (c), (d), (h), or (i).
Tobacco Product Initial Ingredient Listing;                135               1             135  2..............................      270            0.66
 Form FDA 3742 Listing of Ingredients
 (Electronic and Paper submissions); Section
 904(a)(1) or (c).
Tobacco Product Renewal Ingredient Listing;                135               2             270  0.40 (24 minutes)..............      108            1.32
 Form FDA 3742 Listing of Ingredients
 (Electronic and Paper submissions); Section
 904(a)(1) or (c).
Obtaining a Dun and Bradstreet D-U-N-S Number.               8               1               8  0.5............................        4  ..............
Tobacco Product Ingredient Listing Electronic              135               1             135  3..............................      405            0.66
 and Paper submission.
                                               ---------------------------------------------------------------------------------------------------------
    Total.....................................  ..............  ..............  ..............  ...............................    1,084            3.96
--------------------------------------------------------------------------------------------------------------------------------------------------------

    On April 21, 2015, the FDA published a 60-day notice (80 FR 22202)
requesting public comments in the Federal Register. In this notice, the
total amount of burden hours for this collection was incorrectly listed
as 1,354 hours. After an internal review of burden for this collection,
FDA realized that the burden in the 60-day Federal Register notice did
not take into account new information from another Federal Agency
(which revised the number of respondents slightly upward), and the use
of a new electronic registration and product listing submission system.
To correct this oversight, FDA is revising the number of respondents
upward, from 125 to 135 respondents. FDA also has incorporated the use
of a new electronic system into this collection, so the total hours
were revised from 1,354 hours to 1,084 hours in table 1.
    The burden estimates have been updated to fully incorporate the use
of FDA's new electronic system known as FURLS for submitting
registration and product listing information to FDA. This system allows
companies to enter information quickly and easily. For example, product
label pictures can be uploaded directly into the system and FDA
anticipates that most, if not all companies already have electronic
versions of their labels for printing, sales, or marketing purposes.
FDA anticipates that the initial entry registration and initial product
listing will each take 2 hours per entity.
    Under section 905, once information is entered into FURLS, the
twice yearly conformation or updates to product lists are expected to
be simplified as all information previously entered is maintained and
visible in the system. Therefore, FDA expects that ongoing maintenance
of the product listing information will take 30 minutes twice a year,
or a total of 1 hour annually. This is broken down into 12 minutes for
recurring Registration and Listing each year, and 24 minutes twice a
year for recurring Product Ingredient Listings, or a total of 48
minutes annually.

    Based on data shared by another Federal Agency, FDA estimates that
135 establishments will initially submit one report, and then will
submit confirmation or update reports on a semiannual basis.
    FDA estimates that the confirmation or updating of registration
information as required by section 905 will take 12 minutes annually
per confirmation or update per establishment.
    FDA estimates that the submission of product listings required by
section 905 for each establishment will take 2 hours initially. FDA
also estimates that the confirmation or updating of product listing
information required by section 905 will take 48 minutes annually for
two confirmations or updates per establishment.
    FDA estimates that obtaining an optional Dun and Bradstreet D-U-N-S
number will take 0.5 hours, and that 8 respondents (1 percent x 135 =
1.35 of establishments required to register under section 905, and 5
percent x 135 = 6.75 of submitters required to list ingredients under
section 904) will not already have a Dun and Bradstreet D-U-N-S number.
    FDA estimates that the submission of ingredient listing information
as required by section 904 of the act will take 3 hours per tobacco
product.

    Dated: July 22, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-18410 Filed 7-27-15; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 76, Number 121 (Thursday, June 23, 2011)]
[Notices]
[Pages 36947-36949]
[FR Doc No: 2011-15674]

-----------------------------------------------------------------------

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-64700; File No. SR-NASDAQ-2010-134]

Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Order
Disapproving Proposed Rule Change To Adopt Additional Criteria for
Listing Companies That Have Indicated Their Business Plan Is To Buy and
Hold Commodities

 June 17, 2011.

I. Introduction

    On October 15, 2010, The NASDAQ Stock Market LLC (``Nasdaq'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change to adopt additional criteria for listing companies
that have indicated their business plan is to buy and hold commodities.
The proposed rule change was published for comment in the Federal
Register on November 3, 2010.\3\ On December 9, 2010, the Commission
extended the time period in which to either approve the proposed rule
change or to institute proceedings to determine whether to disapprove
the proposed rule change, to February 1, 2011.\4\ The Commission
received one comment letter on the proposal.\5\ On January 31, 2011,
the Commission issued an order instituting proceedings to determine
whether to disapprove the proposed rule change (``Order Instituting
Disapproval Proceedings'').\6\ The Commission received no comments on
the proceedings to determine whether to disapprove the proposed rule
change, and Nasdaq did not provide a response to the Commission's
grounds for disapproval under consideration as set forth in the Order
Instituting Disapproval Proceedings. On April 8, 2011, the Commission
extended the time period for Commission action on the proceedings to
determine whether to disapprove the proposed rule change, to July 1,
2011.\7\ This order disapproves the proposed rule change.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 63207 (October 28,
2010), 75 FR 67788.
    \4\ See Securities Exchange Act Release No. 63508 (December 9,
2010), 75 FR 78300 (December 15, 2010).
    \5\ See Letter from Edward H. Smith, Jr. to Florence E. Harmon,
Deputy Secretary, Commission, dated January 18, 2011.
    \6\ See Securities Exchange Act Release No. 63804 (January 31,
2011), 76 FR 6506 (February 4, 2011).
    \7\ See Securities Exchange Act Release No. 64259 (April 8,
2011), 76 FR 20760 (April 13, 2011).
---------------------------------------------------------------------------

II. Description of the Proposal

    The Exchange proposes to adopt additional listing standards for
companies that have indicated that their business plan is to purchase
and stockpile raw materials or other commodities (``commodity
stockpiling companies''). Under the proposal, such companies are
required to meet all other applicable Nasdaq initial listing
requirements, as well as the following additional listing standards.
First, within 18 months of the effectiveness of its initial public
offering registration statement, or such shorter period as the company
specifies in the registration statement, the company would be required
to invest at least 85% of the net proceeds of the initial public
offering in the raw material or commodity identified in the
registration statement, or return the unused amount pro rata to its
shareholders.\8\
---------------------------------------------------------------------------

    \8\ See proposed Nasdaq IM-5101-3(a).
---------------------------------------------------------------------------

    Second, the company would be required to publish, or facilitate
access to, at no cost and in an easily accessible manner, regular
pricing information regarding the raw material or other commodity from
a reliable, independent source, at least as frequently as current
industry practice but no less than twice per week.\9\
---------------------------------------------------------------------------

    \9\ See proposed Nasdaq IM-5101-3(b).
---------------------------------------------------------------------------

    Third, the company would be required to publish its net market
value on a daily basis, or where pricing information for the raw
material or other commodity is not available on a daily basis, no less
frequently than twice per week.\10\ If the spot price of the raw
material or commodity fluctuates by more than 5%, the company shall
publish the net market value within one business day of the
fluctuation.
---------------------------------------------------------------------------

    \10\ See proposed Nasdaq IM-5101-3(d). Net market value would be
determined by multiplying the volume of the raw material or
commodity held in inventory by the last spot price published or
otherwise relied upon by the company, plus cash and other assets,
less any liabilities.
---------------------------------------------------------------------------

    Fourth, the company would be required to publish the quantity of
the raw material or other commodity held in inventory, the average
price paid, and the company's net market value within two business days
of any change in inventory held.\11\ Where the company contracts to
purchase or sell a material quantity of the raw material or commodity,
such information would be required to be disclosed in a Form 8-K filing
within four business days.
---------------------------------------------------------------------------

    \11\ See proposed Nasdaq IM-5101-3(c).
---------------------------------------------------------------------------

    Fifth, the company would be required to employ the services of one
or more independent third party storage facilities to safeguard the
physical holdings of the raw material or commodity.\12\ Finally, the
company would be required to create a committee comprised solely of
independent directors who shall consider, at least quarterly, whether
the company's purchasing activities have had a measurable impact on the
market price of the raw material or other commodity and shall report
such determinations and make subsequent recommendations to the
company's board of directors.\13\
---------------------------------------------------------------------------

    \12\ See proposed Nasdaq IM-5101-3(e). Under the proposed rule
language, the facility ``should provide services consistent with
those provided by custodians and these must include: storage and
safeguarding; insurance; transfer of the raw material or other
commodity in and out of the facility; visual inspections, spot
checks and assays; confirmation of deliveries to supplier packing
lists; and reporting of transfers and of inventory to the [commodity
stockpiling company] and its auditors.'' The company must oversee
the third party storage facility with its committee of independent
directors.
    \13\ See proposed Nasdaq IM-5101-3(f). The independent directors
may rely upon and shall have the authority to engage and pay an
industry expert in conducting this review. If the company's board of
directors disagrees with or does not accept the recommendations of
the committee, the company will be required to file a Form 8-K with
the Commission outlining the relevant events, the committee's
determinations and recommendations, and the rationale for the board
of directors' determination.
---------------------------------------------------------------------------

    Nasdaq also is proposing to adopt additional audit committee
requirements applicable to commodity stockpiling companies. In addition
to the existing audit committee requirements in Nasdaq rules, audit
committees for commodity stockpiling companies would be required to
establish procedures for the identification and management of potential
conflicts of interest, and would be required to review and approve any
transactions where such

potential conflicts have been identified.\14\
---------------------------------------------------------------------------

    \14\ See proposed Nasdaq Rule 5605(c)(3) and IM-5605. Under the
proposal, the procedures should include any material amendment to
the management agreement, including any change with respect to the
compensation of the manager.
---------------------------------------------------------------------------

III. Comment Letter

    The Commission received one comment letter on the proposal.\15\ The
commenter, a shareholder in SMG Indium Resources Ltd. (``SMG''),
supported the proposal and stated, among other things, that approval of
the proposal would ``support making the market for commodities, such as
[i]ndium, more efficient and transparent by providing investors * * *
with an easier and more cost-effective alternative for investing in
such commodities.'' This commenter further noted that, unlike
commodity-based trust shares, which are designed along the lines of an
exchange-traded fund (``ETF'') structure and offer exposure to very
liquid and actively-traded commodities, commodity stockpiling companies
``provide investment exposure to select strategic and commercial
commodities which do not have substantial liquid and active trading
markets nor extensive and well developed derivative and/or spot markets
and pricing mechanisms.'' The commenter explained his view that the
proposed listing standards would assure appropriate investor protection
in connection with the listing of commodity stockpiling companies, and
cited particular aspects of the proposal, including the frequency and
source of pricing information, the requirement to calculate and
disseminate net market value, and the use of third-party storage
facilities.
---------------------------------------------------------------------------

    \15\ See, note 5, supra.
---------------------------------------------------------------------------

IV. Discussion

    Under Section 19(b)(2)(C) of the Act, the Commission shall approve
a proposed rule change of a self-regulatory organization if the
Commission finds that such proposed rule change is consistent with the
requirements of the Act, and the rules and regulations thereunder that
are applicable to such organization.\16\ The Commission shall
disapprove a proposed rule change if it does not make such a
finding.\17\ The Commission's Rules of Practice, under Rule 700(b)(3),
state that the ``burden to demonstrate that a proposed rule change is
consistent with the [Act] * * * is on the self-regulatory organization
that proposed the rule change'' and that a ``mere assertion that the
proposed rule change is consistent with those requirements * * * is not
sufficient.'' \18\
---------------------------------------------------------------------------

    \16\ 15 U.S.C. 78s(b)(2)(C)(i).
    \17\ 15 U.S.C. 78s(b)(2)(C)(ii); see also 17 CFR 201.700(b)(3)
and note 18 infra, and accompanying text.
    \18\ 17 CFR 201.700(b)(3). The description of a proposed rule
change, its purpose and operation, its effect, and a legal analysis
of its consistency with applicable requirements must all be
sufficiently detailed and specific to support an affirmative
Commission finding. See id. Any failure of a self-regulatory
organization to provide the information solicited by Form 19b-4 may
result in the Commission not having a sufficient basis to make an
affirmative finding that a proposed rule change is consistent with
the [Act] and the rules and regulations issued thereunder that are
applicable to the self-regulatory organization. Id.
---------------------------------------------------------------------------

    After careful consideration, the Commission does not find that the
proposed rule change is consistent with the requirements of the Act and
the rules and regulations thereunder applicable to a national
securities exchange.\19\ In particular, the Commission does not find
that the proposed rule change is consistent with Section 6(b)(5) of the
Act,\20\ which requires that the rules of a national securities
exchange be designed, among other things, to prevent fraudulent and
manipulative acts and practices, to promote just and equitable
principles of trade, to remove impediments to and perfect the mechanism
of a free and open market and a national market system, and to protect
investors and the public interest.
---------------------------------------------------------------------------

    \19\ In disapproving the proposed rule change, the Commission
has considered the proposed rule's impact on efficiency,
competition, and capital formation. 15 U.S.C. 78c(f).
    \20\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The development and enforcement of appropriate standards governing
the initial and continued listing of securities on an exchange is an
activity of critical importance to financial markets and the investing
public.\21\ Listing standards, among other things, serve as a means for
an exchange to screen issuers and to provide listed status only to bona
fide companies that have or, in the case of an initial public offering,
will have sufficient public float, investor base, and trading interest
to provide the depth and liquidity necessary to promote fair and
orderly markets. Adequate listing standards are especially important
given the expectations of investors that exchanges will appropriately
vet listed companies and effectively monitor the fairness and
efficiency of trading in the securities of listed companies on the
exchange. A critical aspect of assuring fair and efficient exchange
trading is the widespread availability of timely and reliable
information that will directly impact the price of the listed security.
This is particularly true for derivatives and other similar securities,
where the price of the listed security is highly correlated with the
price of the underlying securities or commodities.\22\ Further, the
rules of the exchange should provide appropriate mechanisms to assure
effective surveillance of trading in listed companies to deter and
detect manipulation, fraud or other illegal practices.
---------------------------------------------------------------------------

    \21\ See, e.g., Securities Exchange Release Act No. 58228 (July
25, 2008), 73 FR 44794 (July 31, 2008).
    \22\ See, e.g., Securities Exchange Act Release No. 50603
(October 28, 2004), 69 FR 64614 (November 5, 2004) (SR-NYSE-2004-22)
(approving the New York Stock Exchange's (``NYSE'') proposal for the
listing and trading of streetTRACKS Gold Shares (``Gold Shares'')).
In its approval order, the Commission noted that the gold spot
market is extremely deep and liquid, and that reliable gold price
information is available to investors in the Gold Shares. Further,
the trustee for the Gold Shares agreed to provide on its public Web
site continuously updated information, from an unaffiliated source,
with respect to the spot price of gold, as well as the intraday
indicative value (the estimated net asset value) of a Gold Share on
an essentially real-time basis. In its approval order, the
Commission found that the dissemination of this information would
facilitate transparency with respect to the Gold Shares and diminish
the risk of manipulation or unfair informational advantage. The
Commission also found that the unique liquidity and depth of the
gold market, together with an intermarket surveillance sharing
agreement with a futures market related to gold financial
instruments and the adoption of specific NYSE rules to address and
monitor dealings by Gold Share market makers and their member firms
in the underlying gold market, would create the basis for NYSE to
monitor for fraudulent and manipulative practices in the trading of
the Gold Shares. Id.
---------------------------------------------------------------------------

    Nasdaq's proposal would authorize a national securities exchange,
for the first time, to list the securities of an operating company that
simply plans to buy and hold a commodity or other raw material. A
liquid market may not exist for the underlying commodity or other raw
material to be held by the commodity stockpiling company. Indeed, the
commenter, an SMG shareholder, noted that commodity stockpiling
companies ``provide investment exposure to select strategic and
commercial commodities which do not have substantial liquid and active
trading markets nor extensive and well developed derivative and/or spot
markets and pricing mechanisms,'' but believed that the proposed
listing standards would provide adequate investor protections.
    In the Order Instituting Disapproval Proceedings, however, the
Commission noted several concerns that raised questions as to whether
the Nasdaq proposal is consistent with the requirements of Section
6(b)(5) of the Act, including whether the nature of the required
pricing information, and the frequency and manner of its dissemination,
would prevent manipulation, promote just and

equitable principles of trade, perfect the mechanism of a free and open
market and the national market system, or protect investors and the
public interest.\23\ Specifically, the Commission stated that the
proposal raises issues as to: (1) Whether the dissemination of up-to-
date pricing information twice per week about the sole asset of an
operating company would be sufficient to support the fair and efficient
exchange trading of its securities; (2) in the absence of a liquid and
transparent market for the commodity or other raw material held by the
company, whether the pricing information from the ``independent
source'' would in fact have sufficient reliability and integrity, or
whether there are risks that information could be manipulated; (3)
whether there would be risks such pricing information may be available
to some market participants sooner than others, thereby giving the
former an unfair trading advantage; and (4) whether Nasdaq's proposal
adequately addresses any special risks to investors that might be
presented by the exchange trading of an operating company in the
business solely of stockpiling an illiquid commodity.
---------------------------------------------------------------------------

    \23\ See supra note 6.
---------------------------------------------------------------------------

    The Commission invited interested persons to submit written views
with respect to these or other concerns with the Nasdaq proposal.
Neither Nasdaq nor any other person submitted comments in response to
the Commission's request.
    The Commission remains concerned about the issues raised in the
Order Instituting Disapproval Proceedings. Under the Nasdaq proposal,
the business plan of a ``commodity stockpiling company'' that could be
listed on Nasdaq would simply be to purchase and stockpile raw
materials or other commodities, with the result that the sole asset of
the listed company could be a relatively illiquid commodity.
Accordingly, the value of the equity securities of the commodity
stockpiling company would depend almost exclusively on the value of the
underlying commodity.
    The Commission is concerned that Nasdaq's proposal, to permit
dissemination of up-to-date pricing information on the commodity
stockpiled as infrequently as twice per week, would be inadequate for
market participants to fairly and efficiently assess the value of the
listed company and trade its securities on the exchange.\24\ In
addition, the Commission is concerned that, if the market for the
commodity stockpiled is illiquid and opaque, the pricing information
disseminated at least biweekly by the ``independent source'' may in
fact not be reliable, despite the best efforts of the pricing service.
The Commission notes that the proposal does not define what would
constitute a ``reliable, independent source'' and does not set forth
any standards to ensure the reliability and integrity of the pricing
information of the underlying commodity or other raw material. Finally,
the Commission is concerned that, because of the potential infrequency
and irregularity of pricing information on the underlying commodity,
and its consequent importance, there is a risk that some market
participants--perhaps those party to, or with knowledge of, the
transaction in the underlying commodity--would have access to price-
moving market information before it is reported to the pricing service
and publicly disseminated in accordance with the Nasdaq proposal. This
could provide an opportunity for an unfair trading advantage in the
securities of the commodity stockpiling company to those with advance
access to any information that affects pricing. In addition, there
might be the potential for manipulation through the reporting of false
or misleading transaction information to the pricing service. This type
of activity could be facilitated by the fact that transactions in
illiquid markets are infrequent and often self-reported by the parties
in the trade. The incentive to utilize an unfair trading advantage or
to manipulate prices in this way could be magnified by the exchange
listing of an investment vehicle that allowed someone to profit from
such an advantage or manipulation.
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    \24\ The sole comment letter stated that Nasdaq's proposal would
allow companies such as SMG to list its securities on Nasdaq. The
commenter states that indium does not ``have substantial liquid and
active trading markets nor extensive and well developed derivative
and/or spot markets and pricing mechanisms.'' See note 5, supra. The
commenter notes that SMG has engaged Metal Bulletin PLC to be the
pricing source of indium. According to the commenter, Metal Bulletin
publishes indium prices twice per week, on Wednesdays and Fridays,
and the source of the price information can be any entity regularly
involved in buying or selling indium (currently five producers, four
consumers, and three large traders). The commenter notes that Metal
Bulletin requests trade information from these sources (such as
price, quantity, date of transactions and location or origin of
material), and then publishes the final price after adjustment for
outliers, provided that a minimum of six sources provided trading
information.
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    Because of these issues with respect to the nature of the required
pricing information, and the frequency and manner of its dissemination,
the Commission is concerned the proposal is not designed, among other
things, to prevent manipulation, promote just and equitable principles
of trade, perfect the mechanism of a free and open market and a
national market system, and to protect investors and the public
interest, as required by Section 6(b)(5) of the Exchange Act. Nasdaq
did not respond to, or otherwise address, any of these concerns, which
were articulated by the Commission in the Order Instituting Disapproval
Proceedings. As noted above, Rule 700(b)(3) of the Commission's Rules
of Practice states that the ``burden to demonstrate that a proposed
rule change is consistent with the [Act] * * * is on the self-
regulatory organization that proposed the rule change'' and that a
``mere assertion that the proposed rule change is consistent with those
requirements * * * is not sufficient.'' \25\
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    \25\ 17 CFR 201.700(b)(3).
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    For the reasons set forth above, the Commission does not believe
that the Exchange has met its burden to demonstrate that the proposed
rule change is consistent with the requirements of the Act and the
rules and regulations thereunder.

V. Conclusion

    For the foregoing reasons, the Commission does not find that the
proposed rule change is consistent with the requirements of the Act and
the rules and regulations thereunder applicable to a national
securities exchange, and in particular, Section 6(b)(5) of the Act.
    It Is Therefore Ordered, pursuant to Section 19(b)(2) of the Act,
that the proposed rule change (SR-NASDAQ-2010-134) be, and it hereby
is, disapproved.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\26\
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    \26\ 17 CFR 200.30-3(a)(12).
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Cathy H. Ahn,
Deputy Secretary.
[FR Doc. 2011-15674 Filed 6-22-11; 8:45 am]
BILLING CODE 8011-01-P