[Federal Register Volume 80, Number 15 (Friday, January 23, 2015)]
[Notices]
[Pages 3685-3687]
[FR Doc No: 2015-01069]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-74083; File No. SR-NYSEMKT-2015-01]

Self-Regulatory Organizations; NYSE MKT LLC; Notice of Filing and
Immediate Effectiveness of Proposed Rule Change Amending Sections 140
and 141 of The NYSE MKT Company Guide To Adopt A New Flat Annual Fee of
$5,000 for Listed Warrants

January 16, 2015.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby
given that, on January 2, 2015, NYSE MKT LLC (the ``Exchange'' or
``NYSE MKT'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been prepared by the Exchange. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend Sections 140 and 141 of the NYSE MKT
Company Guide (the ``Company Guide'') to adopt a new flat annual fee of
$5,000 for listed warrants with effect from January 1, 2015. The
Exchange also proposes to amend Section 140 of the Company Guide to
make clear that the initial fee waiver for securities transferring from
another national securities exchange or dual listing on the Exchange
are applicable to all categories of securities. The text of the
proposed rule change is available on the Exchange's Web site at
www.nyse.com, at the principal office of the Exchange, and at the
Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the self-regulatory organization
included statements concerning the purpose of, and basis for, the
proposed rule change and discussed any comments it received on the
proposed rule change. The text of those statements may be examined at
the places specified in Item IV below. The Exchange has prepared
summaries, set forth in sections A, B, and C below, of the most
significant parts of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange proposes to amend Sections 140 and 141 of the Company
Guide to adopt a new flat annual fee of $5,000 for listed warrants with
effect from January 1, 2015. The Exchange also proposes to amend
Section 140 of the Company Guide to make clear that the initial fee
waiver for securities transferring from another national securities
exchange or dual listing on the Exchange are applicable to all
categories of securities.
    Currently, Section 140 of the Company Guide provides that listed
warrants are subject to the same initial and annual fees as common
stock. The Exchange proposes to eliminate the reference to the annual
fees for warrants in Section 140 and to add a new subparagraph of
Section 141 which will establish a flat annual fee for warrants of
$5,000 with effect from January 1, 2015. The Exchange notes that
Section 105 of the Company Guide, which establishes initial listing
standards for warrants, provides that warrants qualify for listing only
if the common stock for which the warrants are exercisable are listed
on the Exchange or another national securities exchange. Currently, the
common stock into which all warrants listed on the Exchange are
exercisable is listed either on the Exchange itself or on the NYSE and
(while Section 105 would permit the listing of warrants exercisable for
common stock listed on any national securities exchange, including
those unaffiliated to NYSE MKT) the Exchange anticipates this will
generally remain the case going forward. NYSE Regulation is responsible
for all oversight of the compliance with applicable listing rules by
issuers and securities listed on both the Exchange and the NYSE. Almost
all regulatory obligations imposed upon listed issuers in connection
with a warrant listing, including with respect director independence,
also arise in connection with the issuer's common stock listing.
Accordingly, because NYSE Regulation is already conducting almost all
of the regulatory oversight necessary in connection with a warrant
listing because the issuers listing warrants on the Exchange also have
their common stock listed on the Exchange or the NYSE, the incremental
resources

devoted to the regulation of the listed warrants are very limited and
the Exchange therefore believes it is reasonable to charge only a
modest fixed annual fee for the listing of warrants.
    Section 140 of the Company Guide provides a waiver of the initial
listing fees to companies transferring their securities from another
national securities exchange or dual listing their securities on the
Exchange that remain listed on another national securities exchange.
The Exchange has always interpreted this waiver as applying to all
categories of securities listed on the Exchange and not just to common
stocks or common stock equivalents. The Exchange proposes to amend the
language of the rule to make this consistent interpretation more
transparent.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) of the Act,\4\ in general, and furthers the
objectives of Sections 6(b)(4) \5\ of the Act, in particular, in that
it is designed to provide for the equitable allocation of reasonable
dues, fees, and other charges among its members and issuers and other
persons using its facilities. The Exchange also believes that the
proposed rule change is consistent with Section 6(b)(5) \6\ of the Act
in that it is not designed to permit unfair discrimination between
customers, issuers, brokers, or dealers.
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    \4\ 15 U.S.C. 78f(b).
    \5\ 15 U.S.C. 78f(b)(4).
    \6\ 15 U.S.C. 78f(b)(5).
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    The Exchange believes that amending Section 141 of the Company
Guide to provide a modest flat annual fee for listed warrants is
reasonable because the resulting fees would better reflect the
Exchange's costs related to such listing. In this regard, the Exchange
notes that all issuers currently listing warrants on the Exchange also
list their common stock on the Exchange itself or on the NYSE. The
Exchange further notes that the majority of costs associated with
providing services to these issuers as well as the Exchange's
regulatory burden arise as a result of their common stock listing and
there is only a minimal incremental cost as a result of their warrant
listings. Accordingly, the Exchange believes it is appropriate to
charge a modest flat fee for warrant listings. The Exchange further
believes that the proposed annual fees are equitably allocated because
all issuers will be subject to the same $5,000. The amendment to
Section 140 to clarify the treatment for initial listing fee purposes
of warrants transferred from another national securities exchange or
dual listed on the Exchange simply makes the existing interpretation of
the rule more transparent and does not affect in any way the amount of
fees collected.

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act. The proposed rule change is
designed to ensure that the fees charged by the Exchange accurately
reflect the services provided and benefits realized by listed
companies. The proposed fee increases will apply to all issuers listed
on the Exchange, therefore they will be equitably allocated amongst all
issuers and will not be unfairly discriminatory towards an individual
issuer or class of issuers. Further, because issuers have the option to
list their securities on a different national securities exchange, the
Exchange does not believe that the proposed fee changes impose a burden
on competition.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    No written comments were solicited or received with respect to the
proposed rule change.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    The foregoing rule change is effective upon filing pursuant to
Section 19(b)(3)(A) \7\ of the Act and subparagraph (f)(2) of Rule 19b-
4 \8\ thereunder, because it establishes a due, fee, or other charge
imposed by the Exchange.
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    \7\ 15 U.S.C. 78s(b)(3)(A).
    \8\ 17 CFR 240.19b-4(f)(2).
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    At any time within 60 days of the filing of such proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings under
Section 19(b)(2)(B) \9\ of the Act to determine whether the proposed
rule change should be approved or disapproved.
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    \9\ 15 U.S.C. 78s(b)(2)(B).
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IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-NYSEMKT-2015-01 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.

All submissions should refer to File Number SR-NYSEMKT-2015-01. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of the filing also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-NYSEMKT-2015-01 and should
be submitted on or before February 13, 2015.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\10\
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    \10\ 17 CFR 200.30-3(a)(12).
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Brent J. Fields,
Secretary.
[FR Doc. 2015-01069 Filed 1-22-15; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 81, Number 238 (Monday, December 12, 2016)]
[Notices]
[Pages 89559-89562]
[FR Doc No: 2016-29649]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-79477; File No. SR-NYSE-2016-83]

Self-Regulatory Organizations; New York Stock Exchange LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change
Amending Rule 67 To Modify the Web site Data Publication Requirements
Relating to the Regulation NMS Plan To Implement a Tick Size Pilot
Program

December 6, 2016.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby
given that on November 30, 2016, New York Stock Exchange LLC (``NYSE''
or the ``Exchange'') filed with the Securities and Exchange Commission
(the ``Commission'') the proposed rule change as described in Items I
and II below, which Items have been prepared by the self-regulatory
organization. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend Rule 67 to modify the Web site data
publication requirements relating to the Regulation NMS Plan to
Implement a Tick Size Pilot Program (``Plan''). The proposed rule
change is available on the Exchange's Web site at www.nyse.com, at the
principal office of the Exchange, and at the Commission's Public
Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the self-regulatory organization
included statements concerning the purpose of, and basis for, the
proposed rule change and discussed any comments it received on the
proposed rule change. The text of those statements may be examined at
the places specified in Item IV below. The Exchange has prepared
summaries, set forth in sections A, B, and C below, of the most
significant parts of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    On August 25, 2014, NYSE Group, Inc., on behalf of the Exchange,
NYSE MKT LLC, NYSE Arca, Inc., the Bats BZX Exchange, Inc. f/k/a BATS
Exchange, Inc. (``BZX''), BATS BYX Exchange, Inc. f/k/a BATS Y-
Exchange, Inc. (``BYX''), Bats EDGA Exchange, Inc., Bats EDGX Exchange,
Inc., Chicago Stock Exchange, Inc., Financial Industry Regulatory
Authority, Inc. (``FINRA''), NASDAQ OMX BX, Inc., NASDAQ OMX PHLX LLC,
and the Nasdaq Stock Market LLC (collectively ``Participants'') filed
with the Commission, pursuant to Section 11A of the Act \4\ and Rule
608 of Regulation NMS thereunder,\5\ the Plan to Implement a Tick Size
Pilot Program.\6\ The Participants filed the Plan to comply with an
order issued by the Commission on June 24, 2014.\7\ The Plan was
published for comment in the Federal Register on November 7, 2014, and
approved by the Commission, as modified, on May 6, 2015.\8\ The
Commission approved the Pilot on a two-year basis, with implementation
to begin no later than May 6, 2016.\9\ On November 6, 2015, the SEC
exempted the Participants from implementing the Pilot until October 3,
2016.\10\ Under the revised Pilot implementation date, the Pre-Pilot
data collection period commenced on April 4, 2016. On September 13,
2016, the SEC exempted the Participants from the requirement to fully
implement the Pilot on October 3, 2016, to permit the Participants to
implement the pilot on a phased-in basis, as described in the
Participants' exemptive request.\11\
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    \4\ 15 U.S.C. 78k-1.
    \5\ 17 CFR 242.608.
    \6\ See Letter from Brendon J. Weiss, Vice President,
Intercontinental Exchange, Inc., to Secretary, Commission, dated
August 25, 2014.
    \7\ See Securities Exchange Act Release No 72460 (June 24,
2014), 79 FR 36840 (June 30, 2014).
    \8\ See Securities Exchange Act Release No. 74892 (May 6, 2015),
80 FR 27513 (May 13, 2015) (``Approval Order'').
    \9\ See Approval Order at 27533 and 27545.
    \10\ See Securities Exchange Act Release No. 76382 (November 6,
2015), 80 FR 70284 (November 13, 2015).
    \11\ See Letter from David S. Shillman, Associate Director,
Division of Trading and Markets, Commission, to Eric Swanson, EVP,
General Counsel and Secretary, Bats Global Markets, Inc., dated
September 13, 2016; see also Letter from Eric Swanson, EVP, General
Counsel and Secretary, Bats Global Markets, Inc., to Brent J.
Fields, Secretary, Commission, dated September 9, 2016.
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    The Plan is designed to allow the Commission, market participants,
and the public to study and assess the impact of increment conventions
on the liquidity and trading of the common stock of small-
capitalization companies. Each Participant is required to comply, and
to enforce compliance by its member organizations, as applicable, with
the provisions of the Plan.
    The Exchange adopted rule amendments to implement the requirements
of the Plan, including relating to the Plan's data collection
requirements and requirements relating to Web site data
publication.\12\ Specifically, with respect to the Web site data
publication requirements pursuant to Section VII and Appendices B and C
to the Plan, Rule 67(b)(2) provides, among other things, that the
Exchange shall make the data required by Items I and II of Appendix B
to the Plan, and collected pursuant to paragraph (b)(2) of Rule 67,
publicly available on the Exchange's Web site on a monthly basis at no
charge and shall not identify the Trading Center that generated the
data. Rule 67(b)(3)(C), provides, among other things, that the Exchange
shall make the data required by Item IV of Appendix B to the Plan, and
collected pursuant to paragraph (b)(3)(A) of Rule 67, publicly
available on the Exchange's Web site on a monthly basis at no charge
and shall not identify the Trading Center that generated the data.
Supplementary Material .70 to Rule 67 provides, among other things,
that the requirement that the Exchange or their DEA make certain data
publicly available on the Exchange's or DEA's Web site pursuant to
Appendix B and C to the Plan shall commence at the beginning of the
Pilot Period.
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    \12\ See Securities Exchange Act Release No. 77468 (March 29,
2016), 81 FR 19269 (April 4, 2016) (Immediate Effectiveness of
Proposed Rule Change Adopting Requirements for the Collection and
Transmission of Data Pursuant to Appendices B and C of Regulation
NMS Plan to Implement a Tick Size Pilot Program) (SR-NYSE-2016-27);
see also Securities Exchange Act Release No. 78813 (September 12,
2016), 81 FR 63825 (September 16, 2016) (Immediate Effectiveness of
Proposed Rule Change to Amend Rule 67 to Modify Certain Data
Collection Requirements of the Regulation NMS Plan to Implement a
Tick Size Pilot Program) (SR-NYSE-2016-63); see also Letter from
John C. Roeser, Associate Director, Division of Trading and Markets,
Commission, to Sherry Sandler, Associate General Counsel, NYSE,
dated April 4, 2016.
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    The Exchange is proposing amendments to Rule 67(b)(2) (regarding
Appendix B.I and B.II data) and Rule 67(b)(3)(C) (regarding Appendix
B.IV data), to provide that data required to be made available on the
Exchange's Web site be published within 120 calendar days following
month end. In addition, the proposed amendments to Supplementary
Material .70 to Rule 67 would provide that, notwithstanding the
provisions of paragraphs (b)(2), (b)(3)(C) and (b)(5), the Exchange
shall make data for the Pre-Pilot period publicly available on the
Exchange's or DEA's Web site pursuant to Appendix B and C to the Plan
by February 28, 2017.\13\
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    \13\ With respect to data for the Pilot Period, the requirement
that the Exchange or their DEA make data publicly available on the
Exchange's or DEA's Web site pursuant to Appendix B and C to the
Plan shall continue to commence at the beginning of the Pilot
Period. Thus, the first Web site publication date for Pilot Period
data (covering October 2016) would be published on the Exchange's or
DEA's Web site by February 28, 2017, which is 120 days following the
end of October 2016.
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    The purpose of delaying the publication of the Web site data is to
address confidentiality concerns by providing for the passage of
additional time between the market information reflected in the data
and the public availability of such information.\14\
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    \14\ See supra note 11.
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    Finally, the Exchange is proposing an amendment to Rule 67(b)(5)
(regarding data described in Item III of Appendix B) to add a provision
identical to Rule 67(b)(2) (as amended above pursuant to the proposed
changes described above to such Rule), which shall require the Exchange
to make the data described in Item III of Appendix B publicly available
on the Exchange Web site within 120 calendar days following month end
at no charge and shall not identify the member organization that
generated the data. The Exchange is proposing such an amendment in
order to add a provision in its rules to comply with such requirement
and provision in the Plan.\15\
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    \15\ See Section VII of the Plan.
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    As noted in Item 2 of this filing, the Exchange has filed the
proposed rule change for immediate effectiveness and has requested that
the Commission waive the 30-day operative delay. If the Commission
waives the 30-day operative delay, the operative date of the proposed
rule change will be the date of filing.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\16\ in general, and furthers the objectives of Section
6(b)(5) of the Act,\17\ in particular, in that it is designed 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, in general, to protect investors and the public interest.
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    \16\ 15 U.S.C. 78f(b).
    \17\ 15 U.S.C. 78f(b)(5).

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

    The Exchange believes that this proposal is consistent with the Act
because it is designed to assist the Participants in meeting their
regulatory obligations pursuant to the Plan and is in furtherance of
the objectives of the Plan, as identified by the SEC. The Exchange
believes that the instant proposal is consistent with the Act in that
it is designed to address confidentiality concerns by permitting the
Exchange to delay Web site publication to provide for passage of
additional time between the market information reflected in the data
and the public availability of such information.

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
result in any burden on competition that is not necessary or
appropriate in furtherance of the purposes of the Act. The Exchange
notes that the proposed rule change implements the provisions of the
Plan, and is designed to assist the Participants in meeting their
regulatory obligations pursuant to the Plan.
    The proposal is intended to address confidentiality concerns that
may adversely impact competition, especially for Pilot Securities that
may have a relatively small number of designated Market Makers, by
permitting the Exchange to delay Web site publication to provide for
passage of additional time between the market information reflected in
the data and the public availability of such information. The Exchange
notes that the proposal does not alter the information required to be
submitted to the SEC.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    No written comments were solicited or received with respect to the
proposed rule change.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A) \18\ of the Act and Rule 19b-
4(f)(6) thereunder.\19\
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    \18\ 15 U.S.C. 78s(b)(3)(A).
    \19\ 17 CFR 240.19b-4(f)(6).
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    A proposed rule change filed under Rule 19b-4(f)(6) \20\ normally
does not become operative prior to 30 days after the date of the
filing. However, pursuant to Rule 19b-4(f)(6)(iii),\21\ the Commission
may designate a shorter time if such action is consistent with the
protection of investors and the public interest. The Exchange has filed
the proposed rule change for immediate effectiveness and has requested
that the Commission waive the requirement that the proposed rule change
not become operative for 30 days after the date of the filing so that
it may become operative immediately.
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    \20\ 17 CFR 240.19b-4(f)(6).
    \21\ 17 CFR 240.19b-4(f)(6)(iii).
---------------------------------------------------------------------------

    The Exchange notes that the proposed rule change implements the
provisions of the Plan, and is designed to assist the Participants in
meeting their regulatory obligations pursuant to the Plan. The proposal
is intended to address confidentiality concerns by permitting the
Exchange to delay Web site publication to provide for passage of
additional time between the market information reflected in the data
and the public availability of such information. The proposal also does
not alter the information required to be submitted to the SEC.
    The Commission believes that waiving the 30-day operative delay is
consistent with the protection of investors and the public interest
because it will allow the Exchange to implement proposed changes that
are intended to address confidentiality concerns. The Commission notes
that some Pilot data was scheduled to be published on November 30,
2016. Therefore, the Commission hereby waives the 30-day operative
delay and designates the proposed rule change to be operative as of
November 30, 2016.\22\
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    \22\ For purposes only of waiving the operative delay for this
proposal, the Commission has considered the proposed rule's impact
on efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act.\23\ If the
Commission takes such action, the Commission shall institute
proceedings to determine whether the proposed rule should be approved
or disapproved.
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    \23\ 15 U.S.C. 78s(b)(3)(C).
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IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-NYSE-2016-83 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.

All submissions should refer to File Number SR-NYSE-2016-83. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of the filing also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-NYSE-2016-83, and should be
submitted on or before January 3, 2017.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\24\
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    \24\ 17 CFR 200.30-3(a)(12).
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Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2016-29649 Filed 12-9-16; 8:45 am]
 BILLING CODE 8011-01-P


Overview of 2,4 DB Risk Assessment Introduction This document summarizes EPA's human health, environmental fate and transport, and ecological risk findings for the pesticide 2,4 DB, as presented fully in the documents:

" 2,4 DB and 2,4 DB DMAS   Report of the Hazard Identification Assessment Review Committee," dated June 13, 2003

" 2,4 DB and 2,4 DMA Toxicology Chapter for RED," dated July 20, 2004

" Environmental Fate and Effects Division Preliminary Risk Assessment for 2,4 DB and 2,4 DB DMAS Reregistration Eligibility Document," dated July 20, 2004

" 2,4 DB and 2,4 DB Dimethylamine Salt: Revised Product Chemistry and Residue Chemistry Summary Documents for the RED," dated July 19, 2004

" 2,4 DB Acute and Chronic Dietary Exposure Assessments for the Reregistration Eligibility Decision," dated July 13, 2004

" 2,4 DB: Revised Occupational and Residential Exposure and Risk Assessments for the RED Document," dated July 19, 2004

" 2,4 DB and 2,4 DB DMAS Human Health Risk Assessment," dated July 19, 2004.

The purpose of this overview is to help the reader understand the conclusions reached in the risk assessments by identifying the key features and findings of the assessments. References to relevant sections in the complete documents are provided to allow the reader to find the place in these assessments where a more detailed explanation is provided.

Risks summarized in this document are those that result only from the use of 2,4 DB. The Food Quality Protection Act ( FQPA) requires that the Agency consider available information concerning the cumulative effects of a particular pesticide's residues and other substances that have a common mechanism of toxicity. The reason for consideration of other substances is due to the possibility that low level exposures to multiple chemical substances that cause a common toxic effect by a common toxic mechanism could lead to the same adverse health effect that would occur at a higher level of exposure to any of the substances individually. Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding for 2,4 DB and any other substances and 2,4 DB does not appear to produce a toxic metabolite produced by 2 other substances. For the purposes of this action, therefore, EPA has assumed that 2,4 DB does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the policy statements released by EPA's Office of Pesticide Programs concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA's website at http:// www. epa. gov/ pesticides/ cumulative.

These 2,4 DB risk assessments and additional supporting documents, are posted on EPA's Internet website http:// docket. epa. gov/ edkpub/ index. jsp and are available in the Pesticide Docket for public viewing. The Agency has determined 2,4 DB will go through a modified 4 phase public participation process because of the availability of highly refined risk assessments. Meetings with stakeholders ( i. e., growers, extension officials, commodity group representatives and other government officials) will be held to discuss the risk assessments, the identified risks and to solicit input on risk mitigation strategies, if needed. This feedback will be used to complete the Reregistration Eligibility Decision ( RED) document, which will include the resulting risk management decisions. The Agency plans to conduct a close out conference call with interested stakeholders to describe the regulatory decisions presented in the RED.

Use Profile ° Herbicide ( systemic): Registered for use on alfalfa, clover, soybean, peanuts, peppermint, spearmint, and trefoil. 2,4 DB and 2,4 DB DMAS are chlorophenoxy herbicides which function by mimicking the action of auxins, plant growth hormones.

° Formulations: 2,4 DB is manufactured as an acid and the dimethylamine salt, 2,4 DBDMAS End use products are formulated either as soluble, emulsifiable, or flowable concentrates.

° Methods of Application: 2,4 DB and its dimethylamine salt ( 2,4 DB DMAS) can be applied either as a broadcast application early season, or a directed spray late season. Ground or aerial applications may be made.

° Use Rates: Maximum label application rates for food/ feed crops range from 0.25 lb ae ( acid equivalents)/ Acre to 1.5 lb ae/ Acre.

° Annual Poundage: Total annual domestic usage is approximately 375,000 pounds active ingredient.

° Tolerances in Use Profile: Currently there are 7 listed tolerances, 4 of which are to be revoked. The Agency is proposing that a total of 14 tolerances need to be completed for 3 the risk assessment. ( A table of tolerances is located on page 40 of the Product Chemistry Summary Document)

° Technical Registrants: Aceto Agricultural Chemicals Corporation, A. H. Marks & Company, Limited, Atanor S. A., Drexel Chemical Company, Makhteshim Agan of North America, Inc.

Hazard Characterization ( For a complete discussion, see section 1.0 of the 2,4 DB Toxicology Chapter and section 3.0 of the 2,4 DB Human Health Risk Assessment)

Data show that 2,4 DB DMAS dissociates to 2,4 DB in rats, after which they share the same metabolic pathway. The toxicity and LOAELs of 2,4 DB and 2,4 DB DMAS were similar in the studies which were conducted with both chemicals. For the above reasons, the same endpoints were selected for both 2,4 DB and 2,4 DB DMAS from an adequate toxicity database. These endpoints are listed below in Tables 1 and 2.

Similarities in the toxicity of 2,4 DB and 2,4 DMAS include:

Forms of both liver and kidney toxicity were noted in subchronic and chronic toxicity studies submitted to the Agency.

Other forms of toxicity included decreased hematological parameters in studies conducted with rats and dogs, and both developmental and offspring toxicity in studies with rats.

Although neurotoxicity has been noted in other phenoxy herbicides, clinical signs suggestive of neurotoxicity with 2,4 DB and 2,4 DB DMAS only occurred at lethal doses.

EPA is required under the Federal Food Drug and Cosmetic Act ( FFDCA), as amended by FQPA, to develop a screening program to determine whether certain substances ( including all pesticide active and other ingredients) " may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen, or other such endocrine effects as the Administrator may designate. 2,4 DB has properties that could indicate Endocrine Disrupting Chemical ( EDC) properties. These include decreased body weights and altered liver function in mice exposed to this herbicide. When the appropriate screening and/ or testing protocols being considered under the Agency's Endocrine Disrupting Screening Program ( EDSP) have been developed, 2,4 DB may be subjected to additional screening and/ or 4 testing to better characterize effects related to endocrine disruption.

Toxicity endpoints and doses were selected from rat studies, rather than dog studies, because of differences in the elimination of phenoxyacetic compounds in dogs compared to other mammalian species. The dog is more sensitive to toxicity from 2,4 DB than is the rat or human, as is the case for 2,4 DB. Although absorption and distribution of chlorophenoxy herbicides and other organic acids is similar across all species evaluated, the half life of elimination for dogs is significantly longer than for all other species considered. Consequently, effects are seen at lower dose levels in dog than in rat. In the case of 2,4 DB, the Agency believes it is appropriate to use endpoints from the rat studies to determine the effects on humans to prevent an overemphasis of risk.

Differences in toxicity were, however noted and include:

2,4 DB DMAS was more irritating than 2,4 DB.

Table 1. Toxicological Endpoints for 2,4 DB ( Dietary)

Exposure Scenario Dose for Risk Assessment and Uncertainty Factor Special FQPA Safety Factor and Level of Concern Study and Toxicological Effects Acute Dietary ( Females 13 50 years of age) NOAEL = 62.5 mg/ kg/ day UF = 100 Acute RfD = 0.6 mg/ kg/ day FQPA SF = 1X aPAD = acute RfD FQPA SF = 0.6 mg/ kg/ day Rat developmental toxicity. LOAEL = 125 mg/ kg/ day based on skeletal variations/ malformations, microphthalmia, post implantation loss Acute Dietary ( General population including infants and children) None N/ A No appropriate endpoint attributable to a single dose from oral toxicity studies was identified.

Chronic Dietary ( All populations) NOAEL= 3 mg/ kg/ day UF = 100 Chronic RfD = 0.03 mg/ kg/ day FQPA SF = 1X cPAD = chronic RfD FQPA SF = 0.03 mg/ kg/ day Chronic/ carcinogenicity study in rats. LOAEL = 30 mg/ kg/ day based on decreased body weight gain and food consumption in females.

UF = uncertainty factor, FQPA SF = Special FQPA safety factor, NOAEL = no observed adverse effect level, LOAEL = lowest observed adverse effect level, PAD = population adjusted dose, ( a = acute, c = chronic) RfD = reference dose, NA = Not Applicable Table 2. Toxicological Endpoints for 2,4 DB ( Non dietary) 5 Exposure Scenario Dose for Risk Assessment and Uncertainty Factor Special FQPA Safety Factor and Level of Concern Study and Toxicological Effects Short Term Dermal ( 1 to 30 days) None N/ A Quantization not required. No systemic toxicity via the dermal route and there are no developmental concerns.

Intermediate Term Dermal ( 1 to 6 months) Oral NOAEL = 15.8 mg/ kg/ day ( dermal absorption = 23%) Residential LOC for MOE = 100 Occupational = 100 Subchronic rat toxicity ( 2,4 DB study) LOAEL = 50 mg/ kg/ day based on decreased body weight gain, increased relative liver/ kidney weight, and microscopic changes Long Term Dermal (> 6 months) Oral NOAEL = 3 mg/ kg/ day ( dermal absorption = 23%) Residential LOC for MOE = 100 Occupational LOC for MOE = 100 Chronic/ carcinogenicity study in rats. LOAEL = 30 mg/ kg/ day based on decreased body weight gain and food consumption in females.

Short Term Inhalation ( 1 to 30 days) Oral NOAEL = 31 mg/ kg/ day ( inhalation absorption = 100%) Residential LOC for MOE = 100 Occupational LOC for MOE = 100 Rat developmental toxicity. LOAEL = 62.5 mg/ kg/ day based on decreased maternal body weight, body weight gain, and food consumption, and clinical signs ( emaciation, few feces)

Intermediate Term Inhalation ( 1 to 6 months) Oral NOAEL = 15.8 mg/ kg/ day ( inhalation absorption = 100%) Residential LOC for MOE = 100 Occupational LOC for MOE = 100 Subchronic rat toxicity ( 2,4 DB study). LOAEL = 50 mg/ kg/ day based on decreased body weight gain, increased relative liver/ kidney weight, and microscopic changes Long Term Inhalation (> 6 months) Oral NOAEL = 3 mg/ kg/ day ( inhalation absorption = 100%) Residential LOC for MOE = 100 Occupational LOC for MOE = 100 Chronic/ carcinogenicity study in rats. LOAEL = 30 mg/ kg/ day based on decreased body weight gain and food consumption in females.

Cancer None N/ A Classified " not likely to be a human carcinogen".

UF = uncertainty factor, FQPA SF = Special FQPA safety factor, NOAEL = no observed adverse effect level, LOAEL = lowest observed adverse effect level, PAD = population adjusted dose, ( a = acute, c = chronic) RfD = reference dose, MOE = margin of exposure, LOC = level of concern, NA = Not Applicable 6 Human Health Risk Assessment Dietary Risk ( Food)

( For a complete discussion, see the Acute and Chronic Dietary Exposure Assessment for 2,4 DB)

Dietary risk assessment incorporates both exposure to and toxicity of a given pesticide. The risk is expressed as a percentage of a maximum acceptable dose ( i. e., the dose which will result in no unreasonable adverse health effects). This dose is referred to as the population adjusted dose ( PAD). The PAD is equivalent to the Reference Dose ( RfD) divided by the special FQPA Safety Factor. EPA is concerned when estimated dietary risk exceeds 100% of the PAD.

The magnitude of the residue data for processed commodities of food/ feed crops that are from presently registered use sites have been evaluated and deemed adequate by the Agency. Based on the submitted studies, a processing factor of 0.72x was used for peanut oil in the dietary assessment and 1x processing factor was used for mint oil and soybean oil.

2,4 DB acute and chronic dietary exposure assessments were conducted using the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database ( DEEMFCIDTM Version 1.30), which incorporates consumption data from USDA's Continuing Surveys of Food Intakes by Individuals ( CSFII), 1994 1996 and 1998.

Acute and chronic dietary exposure estimates were also conducted using the LifelineTM model ( Version 2.0). These LifelineTM assessments were conducted using the same consumption data as the DEEM FCIDTM.

For acute exposure estimates, individual one day food consumption data are used on an individual by individual basis. The reported consumption amounts of each food item can be multiplied by a residue point estimate and summed to obtain a total daily pesticide exposure for a deterministic exposure assessment. The resulting distribution of exposures is expressed as risk as a percentage of the acute PAD ( aPAD).

For chronic dietary exposure assessment, an estimate of the residue level in each food or food form on the food commodity residue list is multiplied by the average daily consumption estimate for that food/ food form. The resulting residue consumption estimate is summed with the residue consumption estimates for all other food/ food forms on the commodity residue list to arrive at the total average estimated exposure. Exposure is expressed in mg/ kg body weight/ day and risk is expressed as a percent of the chronic PAD ( cPAD).

An unrefined dietary risk assessment ( which assumed tolerance level residues and 100% crop treated) was conducted for all supported 2,4 DB food uses for both acute and chronic dietary risk as a screen to determine if more refined analyses were needed. 7 Acute Dietary Risk ( Food)

Acute dietary risk estimates are provided for females 13 49 years old, the only population subgroup of concern. The results using the DEEM FCID and Lifeline models based on conservative residue estimates which showed risk estimates at the 95th percentile of exposure to be < 1% of the aPAD regardless of the model used and were therefore not of concern. Based on the results of the assessment, further refinements are not warranted.

Table 3. Acute Dietary Exposure and Risk Population Subgroup Acute Dietary ( 95th Percentile)

DEEM FCID Lifeline Dietary Exposure ( mg/ kg/ day) % aPAD Dietary Exposure ( mg/ kg/ day) % aPAD Females 13 49 years old 0.000467 0.08 0.000614 0.102 Chronic Dietary Risk ( Food)

The chronic risk estimates presented in Table 4 are below the Agency's level of concern for the general U. S. population (< 1% of the cPAD) and all the population subgroups (  2.2% cPAD). The most highly exposed population subgroup was all infants (< 1 years old).

This assessment was based on conservative residue estimates. Based on the results of the assessment, further refinements are not warranted. 8 Table 4. Chronic Dietary Exposure and Risk Population Subgroup* Chronic Dietary DEEM FCID Lifeline Dietary Exposure ( mg/ kg/ day) % cPAD Dietary Exposure ( mg/ kg/ day) % cPAD General U. S. Population 0.000242 0.8 0.000232 0.8 All Infants (< 1 year old) 0.000661 2.2 0.000554 1.8 Children 1 2 years old 0.000548 1.8 0.000539 1.8 Children 3 5 years old 0.000535 1.8 0.000505 1.7 Children 6 12 years old 0.000373 1.2 0.000346 1.2 Youth 13 19 years old 0.000238 0.8 0.000224 0.7 Adults 20 49 years old 0.000197 0.7 0.000198 0.7 Adults 50+ years old 0.000153 0.5 0.000191 0.6 Females 13 49 years old 0.000185 0.6 0.000228 0.8 * * The values for the highest exposed population for each type of risk assessment are bolded.

Drinking Water Dietary Risk ( For a complete discussion, see section 4.3 of the 2,4 DB Human Health Risk Assessment)

Drinking water exposure to pesticides can occur through groundwater and surface water contamination. EPA considers both acute ( one day) and chronic ( lifetime) drinking water risks and uses either modeling or actual monitoring data, if available, to estimate those risks. To determine the maximum allowable contribution of treated water allowed in the diet, EPA first looks at how much of the overall allowable risk is contributed by food, then calculates a " drinking water level of comparison" ( DWLOC) to determine whether modeled or monitoring levels exceed this level.

The Agency uses a DWLOC as a surrogate to capture risk associated with exposure from pesticides in drinking water. The DWLOCs represent the maximum contribution to the human diet ( in ppb or µ g/ L) that may be attributed to residues of a pesticide in drinking water after food 9 exposure is subtracted from the aPAD or cPAD. Risks from drinking water are assessed by comparing the DWLOCs to the estimated environmental concentrations ( EECs) in surface water and groundwater. Drinking water modeling provides high end to bounding estimates of pesticide concentrations in groundwater and surface water used as drinking water prior to treatment.

The mobility of 2,4 DB in mineral soils was classified as very mobile to moderately mobile. The half life of 2,4 DB in terrestrial field dissipation studies was 2 to 6.7 days. The primary route of dissipation was by transformation, major transformation products being 2,4 dichlorophenoxyacetic acid ( 2,4 D acid, 5.0 15% of the applied) and 2,4 D Phenol ( 5.0 27.3% of the applied). 2,4 D acid was identified as the major degradate degradate in the aerobic and anaerobic soil metabolism studies.

There were monitoring data for 2,4 DB from the United States Geological Survey ( USGS) and the USEPA. Frequency of detections were not sufficient to calculate time weighted means.

Modeling of surface water concentrations of 2,4 DB was performed using the PRZM/ EXAMS model, using alfalfa, peanuts, and soybean applications. Estimated concentrations of 2,4 DB in surface drinking water were the highest from the Texas alfalfa scenario as follows: 318.68  g ae/ L for the 1 in 10 year peak ( acute) 72.40  g ae/ L for the 1 in 10 year annual daily average concentration ( chronicnon cancer) 39.85  g ae/ L for the 36 year annual daily average concentration ( chronic cancer)

No degradation products of 2,4 DB were included in this assessment. The major degradate of 2,4 DB is 2,4 D. According to data from the US Geographical Survey reported in the EFED water memo, 2,4 D is used in virtually the entire country, whereas 2,4 DB use is in discrete areas of the country, which overlap areas of 2,4 D use. Since 2,4 DB accounts for a small percentage of 2,4 D water exposure, both in terms of usage and environmental transformation, water exposure to 2,4 D will be addressed in the 2,4 D RED.

The SCI GROW model estimated the concentration of 2,4 DB in drinking water from shallow ground water sources to be 0.51  g ae/ L. This concentration can be used for both acute and chronic exposure Residential Risk There are no residential uses for 2,4 DB. 10 Aggregate Risk ( For a complete discussion, see section 4.5 of the Human Health Risk Assessment)

Aggregate exposure to a pesticide combines exposure from food, drinking water, and residential sources of exposure. Since there are no residential uses for 2,4 DB, aggregate assessments included exposure via food and drinking water.

Drinking water levels of comparison ( DWLOCs) were calculated for acute and chronic exposures. The DWLOC is the maximum potential concentration that may be present in drinking water without exceeding the level of concern when exposure from food and water were considered together.

An acute DWLOC was calculated only for females 13 49 years of age because this was the only population subgroup for which an endpoint was selected. The concentration of 2,4 DB estimated in water was less than the DWLOC; and therefore EPA has no concern for acute aggregate exposure.

Table 5. DWLOCs for Acute Exposure to 2,4 DB Population Subgroup Acute PAD mg/ kg/ day Food Exposure mg/ kg/ day Target Max Water Exposure mg/ kg/ day Ground Water EEC

g/ L Surface Water EEC

g/ L DWLOC

g/ L Females 13 49 years 0.6 mg/ kg 0.000467 0.600 0.51 318.68 18,000

For chronic aggregate risk, most highly exposed population subgroup was all infants < 1 year old. The concentration of 2,4 DB estimated in water was less than the DWLOC; and therefore EPA has no concern for chronic aggregate exposure.

Table 6. DWLOCs for Chronic Exposure Population Subgroup Chronic PAD mg/ kg/ day Food Exposure mg/ kg/ day Target Max Water Exposure mg/ kg/ day Ground Water EEC

g/ L Surface Water EEC

g/ L DWLOC

g/ L U. S. Population ( total) 0.03 0.000242 0.030 0.51 72.40 1050 All infants (< 1 year) 0.03 0.000661 0.029 0.51 72.40 290 11 Occupational Risk ( For a complete discussion, see section 4.6 of the 2,4 DB Human Health Risk Assessment)

People can be exposed to a pesticide while working through handling, mixing, loading, or applying a pesticide, and reentering a treated site. Handler and worker risks are measured by a Margin of Exposure ( MOE) which determines how close the occupational exposure comes to a No Observed Adverse Effect Level ( NOAEL) taken from animal studies. Generally, MOEs greater than 100 do not exceed the Agency's level of concern. For workers entering a treated site, Restricted Entry Intervals ( REIs) are calculated to determine the minimum length of time required until MOEs exceed 100 and workers can safely re enter.

Occupational Handler Summary

Exposure analyses were performed using the Pesticide Handlers Exposure Database ( PHED).

The target Margin of Exposure ( MOE) for occupational populations is 100, which includes the standard safety factors of 10X for intraspecies variability ( i. e. differences among humans) and 10X for interspecies variability ( differences between humans and animals)

The MOEs for occupational exposures were calculated for short term inhalation exposure and for intermediate term combined dermal and inhalation exposures and are summarized in Tables 7 and 8. All of the short term inhalation MOEs exceed 100 at baseline and respiratory protection is not needed. All of the intermediate term mixer/ loader combined MOEs exceed 100 if single layer PPE ( i. e. baseline clothing and chemical resistant gloves) is worn. The intermediate term MOEs for applicators exceed 100 with baseline PPE. 12 Table 7. 2,4 DB Short Term MOEs for Handlers Exposure Scenario Crop Label Application Rate ( lb ae/ acre) Acres/ Day Baseline Inhalation MOE Mix/ Load Liquids for Aerial Alfalfa, Clover Mint Peanuts ( SW), Soybeans Peanuts ( SE) 1.5 0.75 0.4 0.25 1200 1200 1200 1200 1,000 2,000 3,800 6,000 Mix/ Load Liquids for Groundboom Alfalfa, Clover, CRPA Mint Peanuts ( SW), Soybeans Peanuts ( SE) 1.5 0.75 0.4 0.25 200 200 200 200 6,000 12,000 23,000 36,000 Aerial Application Alfalfa, Clover Mint Peanuts ( SW), Soybeans Peanuts ( SE) 1.5 0.75 0.4 0.25 1200 1200 1200 1200 18,000 35,000 66,000 110,000 Groundboom Application Alfalfa, Clover, CRPA Mint Peanuts ( SW), Soybeans Peanuts ( SE) 1.5 0.75 0.4 0.25 200 200 200 200 9,800 20,000 37,000 59,000 Flag Aerial Application Alfalfa, Clover Mint Peanuts ( SW), Soybeans Peanuts ( SE) 1.5 0.75 0.4 0.25 1200 1200 1200 1200 3,400 6,900 13,000 21,000 13 Table 8. 2,4 DB Intermediate Term MOEs for Handlers Exposure Scenario Crop Average Application Rate ( lb ae/ acre) Acres/ Day Baseline Combined Dermal/ Inhal ation MOE Single Layer Combined MOE Mix/ Load Liquids for Aerial Alfalfa, Clover Mint Peanuts Soybeans 0.55 0.75 0.24 0.13 1200 1200 1200 1200 2.5 1.8 5.7 11 260 190 590 1100 Mix/ Load Liquids for Groundboom Alfalfa, Clover Mint Peanuts Soybeans 0.55 0.75 0.24 0.13 200 200 200 200 15 11 34 64 1500 1100 3600 6600 Aerial Application Alfalfa, Clover Mint Peanuts Soybeans 0.55 0.75 0.24 0.13 1200 1200 1200 1200 1400 1000 3200 5800 NA NA NA NA Groundboom Application Alfalfa, Clover Mint Peanuts Soybeans 0.55 0.75 0.24 0.13 200 200 200 200 2500 1900 5800 11000 2500 1900 5800 11000 Flag Aerial Application Alfalfa, Clover Mint Peanuts Soybeans 0.55 0.75 0.24 0.13 1200 1200 1200 1200 580 430 1300 2500 540 400 1200 2300

Intermediate term handler exposures are less likely to occur because 2,4 DB is applied only once or twice per season. Metabolism studies in rats also indicated that most of the 2,4 DB dose is excreted within 24 hours through the urine and feces.

The amine salt form of 2,4 DB is a severe eye irritant and eye protection is recommended.

Post Application Occupational Risk Post application 2,4 DB exposures can occur in the agricultural environment when workers enter fields recently treated with 2,4 DB to conduct tasks such as scouting and irrigation. Post application exposure to re entry workers is possible because 2,4 DB can be broadcast applied.

Because 2,4 DB is typically applied once or twice per season it is anticipated that 2,4 Db exposure will be primarily short term. Because there is no endpoint for short term dermal exposures, short term post application risks were not assessed. 14

There were no chemical specific worker exposure data submitted for 2,4 DB, therefore, standard values and assumptions were used as discussed below. The following assumptions were made regarding occupational post application:

The average application rates were used because it is highly unlikely workers would be exposed to residues shortly after application for more that thirty consecutive days.

The risks for alfalfa, peanuts and soybeans were assessed using average rates as reported in the QUA report. The risks for mint were assessed at the maximum label rate of 0.75 lb ai/ acre which is slightly less than the rate of 0.8 lb ai/ acre reported in the QUA report.

The initial percent of application rate as Dislodgeable Foliar Residue ( DFR) was assumed to be 20% for all crops.

The post application risk estimates are highly conservative because they are based upon an intermediate term endpoint. Intermediate term exposures are unlikely to occur because 2,4 DB is applied only once or twice per season. Turf Transferable residue data for the other phenoxy herbicides such as 2,4 D and MCPA have indicated that the dissipation is fairly rapid.

Table 9. 2,4 DB Post Application Worker Risks Crop Transfer Coefficient Group Application Rate ( lb a. i./ acre) Intermediate term MOE on Day 0 Low Exposure Scenarios* Medium Exposure Scenarios* High Exposure Scenarios*

Alfalfa Field/ row crop, low/ medium 0.55 4900 325 NA Mint Field/ row crop, low/ medium 0.75 3600 240 NA Peanuts Field/ row crop, low/ medium 0.24 11000 740 NA Soybeans Field/ row crop, low/ medium 0.13 22000 1500 NA * Task descriptions for each crop and exposure scenario are included in Table 10 of the Occupational and Residential Risk Assessment 15 Ecological Risk Environmental Fate and Transport Although this action is for reregistration of the active ingredients 2,4 DB and 2,4 DBDMAS risks were assessed only for 2,4 DB since 2,4 DB DMAS is highly unstable in moist soils and aquatic environments. Consequently, application rates are expressed in pounds of acid equivalents ( ae) rather than pounds of active ingredients ( ai) per acre. Bridging data were submitted by the registrant demonstrating that 2,4 DB DMAS, a salt, rapidly dissociates when exposed to moisture to form 2,4 DB and dimethylamine. It is very important to note, however, that 2,4 DB DMAS could persist under dry soil conditions.

The dissipation of 2,4 DB in soil environments appears to be dependent on leaching and on oxidative microbial mediated degradation. Photodegradation appears to be the main path of dissipation of 2,4 DB in aquatic environments. The mobility of 2,4 DB was classified as very mobile to moderately mobile.

The major degradate of 2,4 DB, 2,4 D, has been shown to be non persistent and mobile in aerobic terrestrial and aquatic environments. Under anaerobic conditions, however, 2,4 D is more persistent. The dissipation of 2,4 D appears to be dependent on oxidative microbial mediated mineralization, photodegradation in water, and leaching.

To estimate potential ecological risk, EPA integrates the results of exposure and ecotoxicity studies using the quotient method. Risk quotients ( RQs) are calculated by dividing exposure estimates by ecotoxicity values, both acute and chronic, for various wildlife species. RQs are then compared to levels of concern ( LOCs). Generally, the higher the RQ, the greater the potential risk. Risk characterization provides further information on the likelihood of adverse effect occurring by considering the fate of the chemical in the environment, communities and species potentially at risk, their spatial and temporal distributions and the nature of the effects observed in studies.

Terrestrial Organism Risk

The greatest potential for risks is to terrestrial non targeted plants from 2,4 DB spray drift and runoff to areas adjacent to or near treated fields. Spray drift may potentially damage plants through direct contact or through soil deposition during seedling emergence. Potential effects on non target terrestrial plants are most likely to occur as a result of spray drift from aerial and ground applications of the liquid formulation.

The non targeted terrestrial plant LOCs for acute risks and endangered species have been exceeded using the highest application rate for alfalfa ( for aerially/ ground applied at a rate of 1.7 lbs ae/ A, 2 times per year with a 30 day interval). The LOCs for acute endangered and non endangered terrestrial plants were exceeded in the following categories: 16 Table 10. Summarized Terrestrial Plant Risk Quotients for Technical 2,4 DB based on seedling emergence for dicots ( carrots) at an application rate of 1.7lbs ae/ acre to alfalfa Scenario Acute Endangered RQs Acute Non endangered RQs adjacent to treated sites semi aquatic areas adjacent to treated sites semi aquatic areas Ground application Dicot 113.33 793.33 8.64 60.51 Aerial application Dicot 234.22 642.22 17.86 48.98 Table 11. Summarized Terrestrial Plant Risk Quotients for Technical 2,4 DB based on vegetative vigor for monocots ( onions) for an application rate of 1.7lbs ae/ acre to alfalfa Scenario Acute Endangered RQs Acute Non endangered RQs Ground application Monocot 1.42 0.21 Aerial application Monocot 7.08 1.05

Acute terrestrial plant LOCs are exceeded for the following categories when average application rates are used for alfalfa, exceedances for all other crop uses were lower:

Table 12. Summarized Terrestrial Plant Risk Quotients for Technical 2,4 DB based on seedling emergence for dicots ( carrots) at an application rate of 0.55 lbs ae/ acre to alfalfa Scenario Acute Endangered RQs Acute Non endangered RQs adjacent to treated sites semi aquatic areas adjacent to treated sites semi aquatic areas Ground application Dicot 36.67 256.67 2.80 19.58 Aerial application Dicot 75.78 207.78 5.78 5.85 Table 13. Summarized Terrestrial Plant Risk Quotients for Technical 2,4 DB based on vegetative vigor for 17 monocots ( onions) for an application rate of 0.55lbs ae/ acre to alfalfa Scenario Acute Endangered RQs Acute Non endangered RQs Ground application Monocot 0.46 0.07 Aerial application Monocot 2.29 0.34

Acute avian LOCs were exceeded for small birds feeding exclusively on short grass and endangered species LOCs were exceeded for small and medium birds feeding on short grass, tall grass, and broadleaf plants/ insects. Based on the acute toxicity studies submitted for birds, there is a large differential between the acute toxicity studies administered as a single gavage dose or when mixed in the feed. This disparity in mortality between the two types of studies suggests that the dietary matrix may have a lowering effect of the toxicity of 2,4 DB.

Quantitative chronic risks to birds were not assessed due to a lack of avian reproduction data.

Predicted residues from the application of 2,4 DB from all uses do not result in exceedances of the acute LOC for mammals. Exceedances of the restricted use and endangered species LOCs for small and medium size mammals do occur for certain food items when using the alfalfa application scenario. When using the soybean and peanut application scenario, endangered species LOCs are exceeded for small mammals feeding exclusively on short grass. Complete tables listing LOC exceedances are located in Appendix D, Tables 5 to 16 of the Environmental Fate and Effects Division Preliminary Risk Assessment.

Chronic mammalian LOCs are exceeded for the maximum residues and two applications for small mammals feeding on short grass, tall grass and broadleaf plants and insects, and medium size mammals feeding on short grass. For a single application at the same rate and the maximum residues, the chronic LOC for small mammals feeding on short grass is exceeded. At one or two applications and using the mean residue values, acute endangered species LOCs are exceeded for two applications of 2,4 DB to alfalfa for small and medium size mammals feeding on short grass.

When assessing the potential chronic risks from the average application rates of 2,4 DB, no mammalian chronic levels of concern are expected to be exceeded for any of the crop scenarios modeled in this risk assessment based on linear extrapolation.

The screening level risk assessment relies on labeled maximum application rates to calculate wildlife dietary exposures. When using average labeled application rates aerially 18 applied at one and two applications ( from BEAD's Quantitative Analysis Report) to any of the crop scenarios modeled, acute levels of concern would not likely be exceeded for mammals. When assessing the potential chronic risks from average application rates of 2,4 DB, no mammalian chronic levels of concern are expected to be exceeded for any of the crop scenarios modeled in the risk assessment.

Since 2,4 DB was practically non toxic to honey bees, the potential for 2,4 DB to have adverse effects on pollinators and other beneficial insects is low.

Aquatic Organism Risk

Although 2,4 DB is classified as practically non toxic to slightly toxic to freshwater fish, simulations of alfalfa scenarios indicate an exceedances of the acute endangered freshwater fish species LOC based on the 1 in 10 year peak estimated by modeling. This exceedance is likely caused by the high runoff vulnerability of the alfalfa scenario coupled with the highest use rate. Factors contributing to runoff vulnerability can be attributed to the pesticide fate properties, soil type, site location, and rainfall patterns and amounts relative to pesticide application.

Freshwater invertebrates are not expected to be at risk for application scenarios examined in the risk assessment.

2,4 DB rapidly degrades to 2,4 D in aquatic environments, and is characterized as slightly toxic to freshwater fish. The potential for risks from 2,4 DB's degradation to 2,4 D in the environment is summarized and addressed in 2,4 D's Registration Eligibility Decision Science Chapter: Endangered Species Assessment.

Risk to Endangered Species The preliminary risk assessment for endangered species indicates that 2,4 DB exceeds the endangered species LOCs for the following scenarios:

( For a complete discussion of LOC exceedances refer to the Environmental Fate and Effects Division revised risk assessment)

Freshwater fish Levels of Concern using the Texas Alfalfa scenario were exceeded in aquatic environments through drift and runoff.

Small mammals feeding on short grass, tall grass, and broadleaf plants/ insects when single or multiple aerial applications are made to alfalfa.

Medium size mammals feeding on short grass, tall grass and broadleaf plants/ insects when multiple aerial applications are made to alfalfa and short grass and broadleaf plants/ insects when a single application is made to alfalfa. 19

Small and medium size birds feeding on short grass, tall grass, and broadleaf plants/ insects when multiple aerial applications are made to alfalfa.

Non target terrestrial plants at the highest application rate.

There are a number of areas of uncertainty in the terrestrial and aquatic organism risk assessments that could potentially lead to an over or under estimate of risk. For a complete discussion refer to Section V of the Environmental Fate and Effects Division Preliminary Risk Assessment.

Data Requirements Toxicology Data Gap: A 28 day inhalation study is required because the use pattern indicates potential repeated exposure via this route. This study should be conducted with 2,4 DB DMAS because of the irritancy from this compound.

Residue Chemistry Deficiencies: Labels that only prohibit the grazing of forage or feeding of hay within 60 days of the application of a tank mix with Lorax 50W application should be against feeding/ grazing soybean forage and harvesting hay for 60 days following any 2,4 DB application.

The submitted plant analytical methods are adequate for data collection but must be adequately validated for each study for which it was used. If any of the submitted analytical methods for plant commodities are proposed as a 2,4 DB tolerance enforcement method then the method should be modified determination of free and conjugated 2,4 DB. An ILV should be performed.

The submitted methods for livestock commodities are adequate for data collection. If the submitted method is proposed as the enforcement method for determining 2,4 DB in livestock commodities then an ILV of the method should be performed.

Additional field trials on clover forage and hay are required at the maximum label rate ( 1.3 lb ae/ A) with a 60 day PHI to reassess the 2,4 DB tolerances. Ten additional trials are recommended in the following regions: 1 ( Region 1), 1 ( Region 2), 1 ( Region 4), 3 ( Region 5), 1 ( Region 6), 1 ( Region 7), 1 ( Region 8), 1 ( Region 9).

Analytical reference standards must be supplied as requested by the EPA National Pesticide Standards Repository for 2,4 DB.

Product Chemistry Deficiencies: There are a number of product chemistry deficiencies for various registrants. Registrants should also submit required data for dibenzo p dioxins and dibenzofurans, and either certify that the suppliers of beginning materials and the manufacturing process for the 2,4 DB products have not 20 changed since the last comprehensive product chemistry review or submit a complete updated product chemistry data package.

Environmental Fate Data:

Bioconcentration in Fish Study

Laboratory Volatility Study

Droplet Size Spectrum Study

Drift Field Evaluation Ecological Effects:

The ecotoxicity database does not contain all the studies needed to perform a complete risk assessment. The following studies are requested:

Seedling Emergence: EFED is requesting the entire seedling emergence and vegetative vigor toxicity studies be conducted using the TEP, in accordance with current policy. Toxicity tests conducted with the TEP would allow for the development of a more appropriate description of the actual risk to non target terrestrial plants.

Aquatic Plant Toxicity Test using 2,4 DB DMAS/ 2,4 DB ( preferably using the Lemna gibba).

Chronic Reproductive Toxicity Study for birds using 2,4 DB or 2,4 DB DMAS.

Estuarine/ marine Fish Acute Toxicity test using 2,4 DB or 2,4 DB DMAS.

Acute Estuarine/ marine Invertebrate test using 2,4 DB or 2,4 DB DMAS.


[Federal Register: October 3, 2007 (Volume 72, Number 191)]
[Notices]
[Page 56407-56409]
[DOCID:fr03oc07-108]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-56552; File No. SR-DTC-2007-10]

Self-Regulatory Organizations; The Depository Trust Company;
Notice of Filing of Proposed Rule Change To Implement the New Issue
Information Dissemination Service for Municipal Securities

September 27, 2007.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder \2\ notice is hereby given that
on August 16, 2007, The Depository Trust Company (``DTC'') filed with
the Securities and Exchange Commission (``Commission'') and on
September 12, 2007, amended \3\ the proposed rule change described in
Items I, II, and III below, which items have been prepared primarily by
DTC. The Commission is publishing this notice to solicit comments on
the proposed rule change from interested parties.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ The amendment changed a misplaced word in a footnote.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The proposed rule change seeks approval to implement the New Issue
Information Dissemination System (``NIIDS'') for municipal securities.
NIIDS is an automated system developed by DTC at the request of the
Securities Industry and Financial Markets Association (``SIFMA'') \4\
in order to improve the mechanism for disseminating new issue
information regarding municipal securities.
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    \4\ The request originated from The Bond Market Association
(``BMA''), which has since merged with the Securities Industry
Association to form SIFMA.
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II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, DTC included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. DTC has prepared summaries, set forth in sections (A),
(B), and (C) below, of the most significant aspects of these
statements.\5\
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    \5\ The Commission has modified the text of the summaries
prepared by DTC.
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(A) Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    Currently, Municipal Securities Rulemaking Board (``MSRB'') Rule G-
14 generally requires municipal securities dealers to report municipal
securities transactions to the MSRB within 15 minutes of the time of
the trade.\6\ Inter-dealer trades eligible for comparison by a clearing
agency are required to be submitted through NSCC's Real Time Trade
Matching System (``RTTM'') within the time frame in Rule G-14. They are
subsequently reported to the MSRB by NSCC. NSCC requires certain
securities information in order to process and report transactions
involving those securities. Therefore, it is necessary that dealers
trading newly issued municipal securities have the securities
information needed for trade submission by the time the trade reporting
is required.
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    \6\ MSRB Rule G-14 RTRS Procedures (a)(ii).
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    Pursuant to current practice in the municipal securities market,
each information vendor works separately to obtain information from
offering documents and underwriters. Each information vendor's success
depends in large part upon the voluntary cooperation of the
underwriters. It is not unusual for information vendors to have
inconsistent information or for some information vendors to receive
information before others. Consequently, critical new issue information
may be missing or inaccurate in the automated trade processing systems
used by dealers to report the initial trades in new issues. This can
result in late trade reports or trade reports that must be canceled and
resubmitted or amended because they contain with inaccurate data.
    NIIDS is designed to improve the process by which new issue
information is provided by underwriters to information vendors by
collecting information about a new issue from underwriters or their
representatives in an electronic format and making that data available
immediately to information vendors. NIIDS is designed to ensure that
information is disseminated as quickly and efficiently as possible
after the information is made available by the underwriters.
    To address concerns that dealers often lack timely access to
electronically formatted securities information necessary to process
and report municipal securities transactions in real-time, MSRB Rule G-
14 includes a three-hour exemption available to dealers transacting in
``when, as, and if issued'' municipal securities that are not syndicate
managers or members, that have not traded the issue, and that do not
have the CUSIP information or indicative data for that issue in their
securities master file (``Reporting Exemption'').\7\ The Reporting
Exemption will expire on December 31, 2007. In order to prepare for the
Reporting Exemption's expiration, SIFMA asked DTC to incorporate a
centralized automated mechanism for the collection and dissemination on
a real-time basis of the required information as part of the planned
reengineering of DTC's underwriting system. DTC built NIIDS to help
make

the collection and dissemination of new issue information with respect
to municipal securities more efficient for the industry.
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    \7\ MSRB Rule G-14 RTRS Procedures (a)(ii)(C).
---------------------------------------------------------------------------

    An industry working group of municipal securities dealers, SIFMA
members, the MSRB, and DTC have identified key data elements required
for the reporting, comparison, confirmation, and settlement of trades
in municipal securities (``NIIDS Data Elements'').
    Initially, DTC is proposing to make NIIDS available to the
municipal securities industry on an optional basis to allow dealers to
have some experience with NIIDS before the MSRB mandates its use. Only
DTC participants or those entities specifically authorized by a
participant (``Correspondent'') may input information on NIIDS.\8\
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    \8\ Participants will be required to identify an authorized
party at the Correspondent with whom DTC may interact.
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    To commence the process, the dissemination agent (``Dissemination
Agent'') for a new issue must input the NIIDS Data Elements thereby
requesting that DTC make the information available to the industry
through NIIDS. DTC will not confirm the NIIDS Data Elements but rather
will act as a conduit to pass along such information to data
vendors.\9\ DTC anticipates the data vendors will then disseminate the
information to the industry thereby allowing dealers to make timely
reporting of their municipal trades. DTC will record the name of the
Dissemination Agent who inputs the Data Elements and the time such
information is submitted. DTC will begin disseminating the data when it
has received authorization from the Dissemination Agent through NIIDS.
In addition, NIIDS will contain the contact information for the
Dissemination Agent that populated the NIIDS Data Elements for a
particular issue to enable users of the data to contact them with
questions or comments.
---------------------------------------------------------------------------

    \9\ Data vendors or others that wish to receive NIIDS Data
Elements must register in advance with DTC.
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    DTC is proposing to provide NIIDS to the industry in order to
facilitate the collection and dissemination of new issue information in
relation to municipal securities. As DTC is only a conduit of the
information and does not confirm the validity of any of the NIIDS Data
Elements, use of NIIDS will constitute an agreement that DTC shall not
be liable for any loss in relation to the dissemination of NIIDS Data
Elements. In the event that inaccurate information is input into NIIDS,
the Dissemination Agent shall bear any and all liability related to
such inaccuracies.
Optional Use of NIIDS
    The MSRB would like dealers to be able to use NIIDS before
requiring them to so by rule.\10\ DTC anticipates that once the
industry is able to use NIIDS, the MSRB will finalize the MSRB proposal
that will effect the expiration of the Reporting Exemption (``Final
MSRB Proposal'') and will file it with the Commission for approval.
Concurrently, DTC plans to collaborate with the MSRB to conform NIIDS
to the Final MSRB Proposal and will seek an approval order from the
Commission to make use of NIIDS a prerequisite for municipal securities
to be DTC-eligible. DTC intends to mandate the use of NIIDS for
municipal securities in April 2008. DTC believes that members of the
municipal securities industry will be using NIIDS during the period
NIIDS is optional (``Test Period'') to become accustomed to using it.
This may result in Dissemination Agents inputting incomplete NIIDS Data
Elements while getting acquainted with NIIDS. Therefore, no one should
rely on the accuracy of the NIIDS Data Elements during the Test Period
but rather must continue to use existing authorized sources of such
information.
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    \10\ The MSRB received comment on proposed rules that would
require underwriters of municipal securities to participate in
NIIDS. See MSRB Notice 2007-10 (March 5, 2007) at http://www.msrb.org.

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    DTC will not charge a service fee to underwriters that input or
receive information through NIIDS. Additionally, DTC will not charge a
service fee to information vendors that will receive information for
further dissemination through NIIDS.\11\
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    \11\ DTC will charge a connectivity fee to underwriters, service
providers, and information vendors that use NIIDS.
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    DTC believes that the proposed rule change is consistent with the
requirements of Section 17A of the Act \12\ and the rules and
regulations thereunder because the proposed changes promote the prompt
and accurate clearance and settlement of securities transactions by
streamlining the collection and dissemination of new issue information
for municipal securities throughout the industry.
---------------------------------------------------------------------------

    \12\ 15 U.S.C. 78q-1.
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(B) Self-Regulatory Organization's Statement on Burden on Competition

    DTC does not believe that the proposed rule change will have any
impact or impose any burden on competition.

(C) Self-Regulatory Organization's Statement on Comments on the
Proposed Rule Change Received From Members, Participants, or Others

    Written comments relating to the proposed rule change have not been
solicited or received. DTC will notify the Commission of any written
comments received by DTC.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Within thirty-five days of the date of publication of this notice
in the Federal Register or within such longer period: (i) As the
Commission may designate up to ninety days of such date if it finds
such longer period to be appropriate and publishes its reasons for so
finding or (ii) as to which the self-regulatory organization consents,
the Commission will:
    (A) By order approve such proposed rule change or
    (B) Institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml.
 ) or     Send an e-mail to<EMAIL_ADDRESS>Please include

File Number SR-DTC-2007-10 on the subject line.

Paper Comments

     Send paper comments in triplicate to Nancy M. Morris,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-DTC-2007-10. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml

). Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written

communications relating to the proposed rule change between the
Commission and any person, other than those that may be withheld from
the public in accordance with the provisions of 5 U.S.C. 552, will be
available for inspection and copying in the Commission's Public
Reference Section, 100 F Street, NE., Washington, DC 20549, on official
business days between the hours of 10 a.m. and 3 p.m. Copies of such
filings also will be available for inspection and copying at the
principal office of DTC and on DTC's Web site at http://www.dtcc.com/downloads/legal/rule_filings/2007/dtc/2007-10.pdf and http://

ttp://

amendment.pdf. All comments received will be posted without change; the
Commission does not edit personal identifying information from
submissions. You should submit only information that you wish to make
available publicly. All submissions should refer to File Number SR-DTC-
2007-10 and should be submitted on or before October 18, 2007.

    For the Commission by the Division of Market Regulation,
pursuant to delegated authority.\13\
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    \13\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
 [FR Doc. E7-19489 Filed 10-2-07; 8:45 am]

BILLING CODE 8011-01-P