[Federal Register Volume 81, Number 72 (Thursday, April 14, 2016)]
[Notices]
[Pages 22140-22143]
[FR Doc No: 2016-08556]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-77569; File No. SR-ISEMercury-2016-07]

Self-Regulatory Organizations; ISE Mercury, LLC; Notice of Filing
of Proposed Rule Change Related to Market Wide Risk Protection

April 8, 2016.
    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 March 29, 2016, ISE Mercury, LLC (the ``Exchange'' or ``ISE
Mercury'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change, as described in Items I, II,
and III 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.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 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 introduce new activity based order
protections as described in more detail below. The text of the proposed
rule change is available on the Exchange's Web site (http://www.ise.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 these statements may be examined at
the places specified in Item IV below. The self-regulatory organization
has prepared summaries, set forth in sections A, B and C below, of the
most significant aspects of such statements.

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

1. Purpose
    The purpose of the proposed rule change is to introduce new risk
protections for orders designed to aid members in their risk management
by supplementing current price reasonability checks with activity based
order protections.\3\ In particular, the Exchange proposes to introduce
two activity based risk protections that will be mandatory for all
members: (1) the ``Order Entry Rate Protection,'' which protects
members against entering orders at a rate that exceeds predefined
thresholds,\4\ and (2) the ``Order Execution Rate Protection,'' which
protects members against executing orders at a rate that exceeds their
predefined risk settings. Both of these risk protections are detailed
in Proposed Rule 714(d), ``Market Wide Risk Protection.'' \5\ The
Exchange will announce the implementation date of the Market Wide Risk
Protection in a circular to be distributed to members prior to
implementation.
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    \3\ The Exchange provides members with limit order price
protections designed to prevent erroneous executions by rejecting
orders priced too far through the market. See Rule 714(b)(2).
    \4\ The Exchange will determine when to initiate the Order Entry
Rate Protection pre-open to allow members time to load their orders
without inadvertently triggering the protection. The precise time
will be established by the Exchange and communicated to members via
circular prior to implementation.
    \5\ The term ``Market Wide Risk Protection'' includes both the
``Order Entry Rate Protection'' and the ``Order Execution Rate
Protection.''
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    Pursuant to the proposed Market Wide Risk Protection rule, the
Exchange's trading system (the ``System'') will maintain one or more
counting programs on behalf of each member that will count the number
of orders entered, and the number of contracts traded on ISE
Mercury.\6\ Members can use multiple counting programs to separate risk
protections for different groups established within the member.\7\ The
counting programs will maintain separate counts, over rolling time
periods specified by the member for each count, of: (1) the total
number of orders entered; and (2) the total number of contracts
traded.\8\ Contracts executed on the agency and contra-side of a two-
sided crossing order will be counted separately for the Order Execution
Rate Protection.
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    \6\ Like the Market Wide Speed Bump functionality offered on the
Exchange pursuant to Rule 804(g)(2), the Market Wide Risk Protection
for ISE Mercury will not apply cross-market to other affiliated
exchanges.
    \7\ The Exchange will explain how members can go about setting
up risk protections for different groups (e.g., business units) in a
circular issued to members.
    \8\ The member's allowable order rate for the Order Entry Rate
Protection is comprised of the parameter defined in (1), while the
allowable contract execution rate for the Order Execution Rate
Protection is comprised of the parameter defined in (2).
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    Members will have discretion to establish the applicable time
period for each of the counts maintained under the Market Wide Risk
Protection, provided that the selected period must be within minimum
and maximum parameters established by the Exchange and announced via
circular.\9\ While the Market Wide Risk Protection is mandatory for all
members, the Exchange is not proposing to establish minimum or maximum
values for the order entry and execution parameters described in (1)
and (2) above. The Exchange believes that this approach will give
members the flexibility needed to appropriately tailor the Market Wide
Risk Protection to their respective risk management needs. In this
regard, the Exchange notes that each member is in the best position to
determine risk settings appropriate for their firm based on the
member's trading activity and business needs. In the interest of
maintaining a fair and orderly market, however, the Exchange will
establish default values for the applicable time period and order entry
and execution parameters in a circular to be distributed to members.
Default values established by the Exchange will apply only to members
that do not submit their own parameters for the Market Wide Risk
Protection.
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    \9\ The Exchange anticipates that the minimum and maximum values
for the applicable time period will be initially set at one second
and a full trading day, respectively.
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    The System will trigger the Market Wide Risk Protection when the
counting program has determined that the member has either (1) entered
during the specified time period a number of orders exceeding its
designated allowable order rate, or (2) executed during the specified
time period a number of contracts exceeding its designated allowable
contract execution rate. In particular, after a member enters an order,
or a member's order is executed, the System will look back over the
specified time period to determine whether the member has exceeded the
threshold that it has set for the total number of orders entered or the
total number of contracts traded, as applicable. If the member's
threshold has been exceeded, the Market Wide Risk Protection will be
triggered and the System will automatically reject all subsequent
incoming orders entered by the member on ISE Mercury. In addition, if
the member has opted in to this functionality, the System will
automatically cancel all of the member's existing orders. The Market
Wide Risk Protection will remain engaged until the member manually
(e.g., via email) notifies the Exchange to enable the acceptance of new
orders; however, the System will still allow members to interact with
existing orders entered before the protection was triggered, including
sending cancel order messages and receiving trade executions for those
orders.
    The Exchange believes that the proposed Market Wide Risk Protection
will assist members in better managing their risk when trading on ISE
Mercury. In particular, the proposed rule change provides functionality
that allows members to set risk management thresholds for the number of
orders entered or contracts executed on the Exchange during a specified
period. This is similar to how other options exchanges have implemented
activity-based risk management protections,\10\ and the Exchange
believes this functionality will likewise be beneficial for ISE Mercury
members.
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    \10\ See Securities Exchange Act Release Nos. 74118 (January 22,
2015), 80 FR 4605 (January 28, 2015) (Notice); 74496 (March 13,
2015), 80 FR 14421 (March 19, 2015) (Approval) (SR-MIAX-2015-03).
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    The examples below illustrate how the Market Wide Risk Protection
would work both for order entry and order execution protections:

    Example 1, Order Entry Rate Protection: Broker Dealer 1
(``BD1'') designates an allowable order rate of 499 orders/1 second.
    @0 milliseconds, BD1 enters 200 orders. (Order total: 200
orders)
    @450 milliseconds, BD1 enters 250 orders. (Order total: 450
orders)
    @950 milliseconds, BD1 enters 50 orders. (Order total: 500
orders)

    Market Wide Risk Protection is triggered on ISE Mercury due to
exceeding 499 orders in 1 second. All subsequent orders are
rejected, and if BD1 has opted in to this functionality, all
existing orders are cancelled. BD1 must contact Market Operations to
resume trading.
    Example 2, Order Execution Rate Protection: BD1 designates an
allowable execution rate of 15,000 contracts/2 seconds.
    @0 milliseconds, BD1 receives executions for 5,000 contracts.
(Execution total: 5,000 contracts)
    @600 milliseconds, BD1 receives executions for 10,000 contracts.
(Execution total: 15,000 contracts)
    @1550 milliseconds, BD1 receives executions for 2,000 contracts.
(Execution total: 17,000 contracts)
    Market Wide Risk Protection is triggered on ISE Mercury due to
exceeding 15,000 contracts in 2 seconds. All subsequent orders are
rejected, and if BD1 has opted in to this functionality, all
existing orders are cancelled. BD1 must contact Market Operations to
resume trading.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the requirements of the Act and the rules and regulations
thereunder that are applicable to a national securities exchange, and,
in particular, with the requirements of Section 6(b) of the Act.\11\
Specifically, the proposed rule change is consistent with Section
6(b)(5) of the Act,\12\ because it is designed to promote just and
equitable principles of trade, remove impediments to and perfect the
mechanisms 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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    \11\ 15 U.S.C. 78f(b).
    \12\ 15 U.S.C. 78f(b)(5).
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    The Exchange believes that the proposed rule change would assist
with the maintenance of a fair and orderly market by establishing new
activity based risk protections for orders. The Exchange currently
offers a risk protection mechanism for market maker quotes that removes
the member's quotes if a specified number of curtailment events occur
during a set time period (``Market Wide Speed Bump'').\13\ The Exchange
believes that this Market Wide Speed Bump functionality has been
successful in reducing market maker risk and now proposes to adopt risk
protections for orders that would allow other members to properly
manage their exposure to excessive risk. In particular, the proposed
rule change would implement two new risk protections based on the rate
of order entry and order execution, respectively. The Exchange believes
that both of these new protections, which together encompass the
proposed Market Wide Risk Protection, would enable members to better
manage their risk when trading options on the Exchange by limiting the
member's risk exposure when systems or other issues result in orders
being entered or executed at a rate that exceeds predefined thresholds.
In today's market the Exchange believes that robust risk management is
becoming increasingly more important for all members. The proposed rule
change would provide an additional layer of risk protection for market
participants that trade on the Exchange.
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    \13\ See Rule 804(g)(2).
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    The proposed Market Wide Risk Protection is similar to risk
management functionality provided by other options exchanges,
including, for example, the MIAX Options Exchange (``MIAX''), which
recently received Commission approval for its ``Risk Protection
Monitor'' for orders.\14\ In particular, the Market Wide Risk
Protection is designed to reduce risk associated with system errors or
market events that may cause members to send a large number of orders,
or receive multiple, automatic executions, before they can adjust their
exposure in the market. Without adequate risk management tools, such as
those proposed in this filing, members could reduce the amount of order
flow and liquidity that they provide. Such actions may undermine the
quality of the markets available to customers and other market
participants. Accordingly, the proposed rule change is designed to
encourage members to submit additional order flow and liquidity to the
Exchange, thereby removing impediments to and perfect [sic] the
mechanisms of a free and open market and a national market system and,
in general, protecting investors and the public interest. In addition,
providing members with more tools for managing risk will facilitate
transactions in securities because, as noted above, the members will
have more confidence that protections are in place that reduce the
risks from potential system errors and market events. As a result, the
new functionality has the potential to promote just and equitable
principles of trade.
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    \14\ See supra note 10.
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B. Self-Regulatory Organization's Statement on Burden on Competition

    In accordance with Section 6(b)(8) of the Act,\15\ the Exchange
does not believe that the proposed rule change would impose any burden
on intermarket or intramarket competition that is not necessary or
appropriate in furtherance of the purposes of the Act. The proposed
Market Wide Risk Protection is similar to risk protections already
available on other options exchanges,\16\ and is designed to be a
competitive offering that would mitigate the risk associated with
trading on the Exchange. Market makers already benefit from Market Wide
Speed Bump functionality available for quotes. The proposed change
would extend new risk protections to orders so that additional market
participants can benefit from risk mitigating functionality. In
addition, the proposed functionality would be mandatory for all
members, and would be made available on an equal and non-discriminatory
basis. As such, the Exchange does not believe that the proposed rule
change would impose any unnecessary burden on competition.
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    \15\ 15 U.S.C. 78f(b)(8).
    \16\ See supra notes 10 and 14.
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C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    The Exchange has not solicited, and does not intend to solicit,
comments on this proposed rule change. The Exchange has not received
any unsolicited written comments from members or other interested
parties.

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

    Within 45 days of the publication date of this notice or within
such longer period (1) as the Commission may designate up to 45 days of
such date if it finds such longer period to be appropriate and
publishes its reasons for so finding or (2) as to which the self-
regulatory organization consents, the Commission will:
    (a) by order approve or disapprove 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 email to<EMAIL_ADDRESS>Please include
File Number SR-

ISEMercury-2016-07 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-ISEMercury-2016-07. 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-ISEMercury-2016-07 and
should be submitted on or before May 5, 2016.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\17\
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    \17\ 17 CFR 200.30-3(a)(12).
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Robert W. Errett,
Deputy Secretary.
[FR Doc. 2016-08556 Filed 4-13-16; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 83, Number 50 (Wednesday, March 14, 2018)]
[Notices]
[Pages 11228-11232]
[FR Doc No: 2018-05180]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2018-0002; Internal Agency Docket No. FEMA-B-1810]

Changes in Flood Hazard Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice lists communities where the addition or
modification of Base Flood Elevations (BFEs), base flood depths,
Special Flood Hazard Area (SFHA) boundaries or zone designations, or
the regulatory floodway (hereinafter referred to as flood hazard
determinations), as shown on the Flood Insurance Rate Maps (FIRMs), and
where applicable, in the supporting Flood Insurance Study (FIS)
reports, prepared by the Federal Emergency Management Agency (FEMA) for
each community, is appropriate because of new scientific or technical
data. The FIRM, and where applicable, portions of the FIS report, have
been revised to reflect these flood hazard determinations through
issuance of a Letter of Map Revision (LOMR). The LOMR will be used by
insurance agents and others to calculate appropriate flood insurance
premium rates for new buildings and the contents of those buildings.
For rating purposes, the currently effective community number is shown
in the table below and must be used for all new policies and renewals.

DATES: These flood hazard determinations will be finalized on the dates
listed in the table below and revise the FIRM panels and FIS report in
effect prior to this determination for the listed communities.
    From the date of the second publication of notification of these
changes in a newspaper of local circulation, any person has 90 days in
which to request through the community that the Deputy Associate
Administrator for Insurance and Mitigation reconsider the changes. The
flood hazard determination information may be changed during the 90-day
period.

ADDRESSES: The affected communities are listed in the table below.
Revised flood hazard information for each community is available for
inspection at both the online location and the respective community map
repository address listed in the table below. Additionally, the current
effective FIRM and FIS report for each community are accessible online
through the FEMA Map Service Center at https://msc.fema.gov for
comparison.

    Submit comments and/or appeals to the Chief Executive Officer of
the community as listed in the table below.

FOR FURTHER INFORMATION CONTACT: Rick Sacbibit, Chief, Engineering
Services Branch, Federal Insurance and Mitigation Administration, FEMA,
400 C Street SW, Washington, DC 20472,<PHONE_NUMBER>, or (email)
[email protected]; or visit the FEMA Map Information
eXchange (FMIX) online at https://www.floodmaps.fema.gov/fhm/fmx_main.html.

SUPPLEMENTARY INFORMATION: The specific flood hazard determinations are
not described for each community in this notice. However, the online
location and local community map repository address where the flood
hazard determination information is available for inspection is
provided.
    Any request for reconsideration of flood hazard determinations must
be submitted to the Chief Executive Officer of the community as listed
in the table below.
    The modifications are made pursuant to section 201 of the Flood
Disaster Protection Act of 1973, 42 U.S.C. 4105, and are in accordance
with the National Flood Insurance Act of 1968, 42 U.S.C. 4001 et seq.,
and with 44 CFR part 65.
    The FIRM and FIS report are the basis of the floodplain management
measures that the community is required either to adopt or to show
evidence of having in effect in order to qualify or remain qualified
for participation in the National Flood Insurance Program (NFIP).
    These flood hazard determinations, together with the floodplain
management criteria required by 44 CFR 60.3, are the minimum that are
required. They should not be construed to mean that the community must
change any existing ordinances that are more stringent in their
floodplain management requirements. The community may at any time enact
stricter requirements of its own or pursuant to policies established by
other Federal, State, or regional entities. The flood hazard
determinations are in accordance with 44 CFR 65.4.
    The affected communities are listed in the following table. Flood
hazard determination information for each community is available for
inspection at both the online location and the respective community map
repository address listed in the table below. Additionally, the current
effective FIRM and FIS report for each community are accessible online
through the FEMA Map Service Center at https://msc.fema.gov for
comparison.

(Catalog of Federal Domestic Assistance No. 97.022, ``Flood
Insurance.'')

    Dated: February 23, 2018.
Roy E. Wright,
Deputy Associate Administrator for Insurance and Mitigation, Department
of Homeland Security, Federal Emergency Management Agency.

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                         Chief executive                         Online location of
        State and county           Location and case       officer of         Community map        letter of map       Date of modification   Community
                                          No.               community          repository             revision                                   No.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Arkansas: Benton................  City of Rogers (17-  The Honorable Greg  City Hall, 301      https://msc.fema.gov/  May 14, 2018.........       050013
                                   06-4054P).           Hines, Mayor,       West Chestnut       portal/advanceSearch.
                                                        City of Rogers,     Street, Rogers,
                                                        301 West Chestnut   AR 72756.
                                                        Street, Rogers,
                                                        AR 72756.
Colorado:
    Boulder.....................  City of Boulder,     Ms. Jane S.         City Hall, 1739     https://msc.fema.gov/  May 31, 2018.........       080024
                                   (17-08-0797P).       Brautigam,          Broadway, 3rd       portal/advanceSearch.
                                                        Manager, City of    Floor, Boulder,
                                                        Boulder, P.O. Box   CO 80306.
                                                        791, Boulder, CO
                                                        80306.
    Broomfield..................  City and County of   The Honorable       Community           https://msc.fema.gov/  May 4, 2018..........       085073
                                   Broomfield, (17-08-  Randy Ahrens,       Development         portal/advanceSearch.
                                   0870P).              Mayor, City and     Department, 1
                                                        County of           DesCombes Drive,
                                                        Broomfield, 1       Broomfield, CO
                                                        DesCombes Drive,    80020.
                                                        Broomfield, CO
                                                        80020.
    Douglas.....................  Town of Parker, (17- The Honorable Mike  Town Hall, 20120    https://msc.fema.gov/  May 18, 2018.........       080310
                                   08-1041P).           Waid, Mayor, Town   East Main Street,   portal/advanceSearch.
                                                        of Parker, 20120    Parker, CO 80138.
                                                        East Main Street,
                                                        Parker, CO 80138.
    Douglas.....................  Unincorporated       The Honorable       Douglas County      https://msc.fema.gov/  May 18, 2018.........       080049
                                   areas of Douglas     Roger Partridge,    Planning            portal/advanceSearch.
                                   County, (17-08-      Chairman, Douglas   Division, 100 3rd
                                   1041P).              County Board of     Street, Castle
                                                        Commissioners,      Rock, CO 80104.
                                                        100 3rd Street,
                                                        Castle Rock, CO
                                                        80104.
    El Paso.....................  City of Colorado     The Honorable John  City Hall, 30       https://msc.fema.gov/  May 17, 2018.........       080060
                                   Springs, (17-08-     Suthers, Mayor,     South Nevada        portal/advanceSearch.
                                   1081P).              City of Colorado    Avenue, Colorado
                                                        Springs, 30 South   Springs, CO 80903.
                                                        Nevada Avenue,
                                                        Suite 601,
                                                        Colorado Springs,
                                                        CO 80903.
    Jefferson...................  City of              The Honorable Herb  City Hall, 4800     https://msc.fema.gov/  May 4, 2018..........       080008
                                   Westminster, (17-    Atchison, Mayor,    West 92nd Avenue,   portal/advanceSearch.
                                   08-0870P).           City of             Westminster, CO
                                                        Westminster, 4800   80031.
                                                        West 92nd Avenue,
                                                        Westminster, CO
                                                        80031.
    Teller......................  City of Woodland     The Honorable Neil  City Hall, 220      https://msc.fema.gov/  Apr. 19, 2018........       080175
                                   Park, (17-08-        Levy, Mayor, City   West South          portal/advanceSearch.
                                   0477P).              of Woodland Park,   Avenue, Woodland
                                                        P.O. Box 9007,      Park, CO 80866.
                                                        Woodland Park, CO
                                                        80866.
    Teller......................  Unincorporated       The Honorable Dave  Teller County       https://msc.fema.gov/  Apr. 19, 2018........       080173
                                   areas of Teller      Paul, Chairman,     Planning            portal/advanceSearch.
                                   County, (17-08-      Teller County,      Department, 800
                                   0477P).              Board of            Research Drive,
                                                        Commissioners,      Woodland Park, CO
                                                        P.O. Box 959,       80866.
                                                        Cripple Creek, CO
                                                        80813.

Delaware: Kent..................  City of Dover, (17-  The Honorable       Department of       https://msc.fema.gov/  Jun. 4, 2018.........       100006
                                   03-0901P).           Robin R.            Planning and        portal/advanceSearch.
                                                        Christiansen,       Inspection, 15
                                                        Mayor, City of      Lookerman Plaza,
                                                        Dover, P.O. Box     Dover, DE 19901.
                                                        475, Dover, DE
                                                        19903.
Florida:
    Charlotte...................  Unincorporated       The Honorable Bill  Charlotte County    https://msc.fema.gov/  Apr. 26, 2018........       120061
                                   areas of Charlotte   Truex, Chairman,    Community           portal/advanceSearch.
                                   County, (17-04-      Charlotte County    Development
                                   7978P).              Board of            Department, 18500
                                                        Commissioners,      Murdock Circle,
                                                        18500 Murdock       Port Charlotte,
                                                        Circle, Suite       FL 33948.
                                                        536, Port
                                                        Charlotte, FL
                                                        33948.
    Hillsborough................  Unincorporated       The Honorable       Hillsborough        https://msc.fema.gov/  May 21, 2018.........       120112
                                   areas of             Sandra Murman,      County Building     portal/advanceSearch.
                                   Hillsborough         Chair,              Services
                                   County, (17-04-      Hillsborough        Division, 601
                                   5216P).              County Board of     East Kennedy
                                                        Commissioners,      Boulevard, Tampa,
                                                        601 East Kennedy    FL 33602.
                                                        Boulevard, Tampa,
                                                        FL 33602.
    Lee.........................  City of Sanibel,     The Honorable       Planning and Code   https://msc.fema.gov/  May 10, 2018.........       120402
                                   (17-04-6485P).       Kevin Ruane,        Enforcement         portal/advanceSearch.
                                                        Mayor, City of      Department, 800
                                                        Sanibel, 800        Dunlop Road,
                                                        Dunlop Road,        Sanibel, FL 33957.
                                                        Sanibel, FL 33957.
    Orange......................  City of Orlando,     The Honorable       City Hall, 400      https://msc.fema.gov/  May 16, 2018.........       120186
                                   (17-04-3609P).       Buddy Dyer,         South Orange        portal/advanceSearch.
                                                        Mayor, City of      Avenue, Orlando,
                                                        Orlando, P.O. Box   FL 32801.
                                                        4990, Orlando, FL
                                                        32802.
    Palm Beach..................  City of Riviera      The Honorable       Department of       https://msc.fema.gov/  May 4, 2018..........       125142
                                   Beach, (17-04-       Thomas A.           Community           portal/advanceSearch.
                                   6959P).              Masters, Mayor,     Development, 600
                                                        City of Riviera     West Blue Heron
                                                        Beach, 600 West     Boulevard,
                                                        Blue Heron          Riviera Beach, FL
                                                        Boulevard,          33404.
                                                        Riviera Beach, FL
                                                        33404.
    Palm Beach..................  Unincorporated       The Honorable       Palm Beach County   https://msc.fema.gov/  May 4, 2018..........       120192
                                   areas of Palm        Melissa McKinlay,   Building            portal/advanceSearch.
                                   Beach County, (17-   Mayor, Palm Beach   Department, 2300
                                   04-6959P).           County, 301 North   North Jog Road,
                                                        Olive Avenue,       West Palm Beach,
                                                        Suite 1201, West    FL 33411.
                                                        Palm Beach, FL
                                                        33401.
    Polk........................  City of Lakeland,    The Honorable       Public Works        https://msc.fema.gov/  May 31, 2018.........       120267
                                   (17-04-7441P).       William Mutz,       Department, 407     portal/advanceSearch.
                                                        Mayor, City of      Fairway Avenue,
                                                        Lakeland, 228       Lakeland, FL
                                                        South               33801.
                                                        Massachusetts
                                                        Avenue, Lakeland,
                                                        FL 33801.
Georgia:
    Floyd.......................  City of Cave         The Honorable       City Hall, 10       https://msc.fema.gov/  May 11, 2018.........       130080
                                   Spring, (17-04-      Dennis Shoaf,       Georgia Avenue,     portal/advanceSearch.
                                   3382P).              Mayor, City of      Cave Spring, GA
                                                        Cave Spring, 10     30124.
                                                        Georgia Avenue,
                                                        Cave Spring, GA
                                                        30124.
    Floyd.......................  Unincorporated       The Honorable       Floyd County        https://msc.fema.gov/  May 11, 2018.........       130079
                                   areas of Floyd       Rhonda Wallace,     Building            portal/advanceSearch.
                                   County, (17-04-      Chair, Floyd        Inspections
                                   3382P).              County Board of     Department, 12
                                                        Commissioners, 12   East 4th Avenue,
                                                        East 4th Avenue,    Rome, GA 30161.
                                                        Rome, GA 30161.
    Gwinnett....................  Unincorporated       The Honorable       Gwinnett County     https://msc.fema.gov/  Mar. 19, 2018........       130322
                                   areas of Gwinnett    Charlotte E.        Planning and        portal/advanceSearch.
                                   County, (17-04-      Nash, Chair,        Development
                                   5175P).              Gwinnett County     Department, 446
                                                        Board of            West Crogan
                                                        Commissioners, 75   Street,
                                                        Langley Drive,      Lawrenceville, GA
                                                        Lawrenceville, GA   30046.
                                                        30046.
    Gwinnett....................  Unincorporated       The Honorable       Gwinnett County     https://msc.fema.gov/  Mar. 22, 2018........       130322
                                   areas of Gwinnett    Charlotte E.        Planning and        portal/advanceSearch.
                                   County, (17-04-      Nash, Chair,        Development
                                   7249P).              Gwinnett County     Department, 446
                                                        Board of            West Crogan
                                                        Commissioners, 75   Street
                                                        Langley Drive,      Lawrenceville, GA
                                                        Lawrenceville, GA   30046.
                                                        30046.
Kentucky: Fayette...............  Lexington-Fayette    The Honorable Jim   Planning Division,  https://msc.fema.gov/  May 16, 2018.........       210067
                                   Urban County         Gray, Mayor,        101 East Vine       portal/advanceSearch.
                                   Government, (17-04-  Lexington-Fayette   Street,
                                   5322P).              Urban County        Lexington, KY
                                                        Government, 200     40507.
                                                        East Main Street,
                                                        Lexington, KY
                                                        40507.
Louisiana: Tangipahoa...........  Unincorporated       The Honorable       Tangipahoa Parish   https://msc.fema.gov/  Mar. 15, 2018........       220206
                                   areas of             Robby Miller,       Department of       portal/advanceSearch.
                                   Tangipahoa Parish,   President,          Public Works,
                                   (17-06-1567P).       Tangipahoa          44512 West
                                                        Parish, P.O. Box    Pleasant Ridge
                                                        215, Amite, LA      Road, Hammond, LA
                                                        70422.              70401.

Maine:
    Knox........................  Town of Isle au      The Honorable       Town Hall, 1 Main   https://msc.fema.gov/  Apr. 6, 2018.........       230227
                                   Haut, (17-01-        Peggi Stevens,      Street, Isle au     portal/advanceSearch.
                                   1368P).              Chair, Town of      Haut, ME 04645.
                                                        Isle au Haut
                                                        Board of
                                                        Selectmen, P.O.
                                                        Box 71, Isle au
                                                        Haut, ME 04645.
    Oxford......................  Town of Hartford,    The Honorable Lee   Town Hall, 1196     https://msc.fema.gov/  May 10, 2018.........       230334
                                   (18-01-0057P).       Holman, Chair,      Main Street,        portal/advanceSearch.
                                                        Town of Hartford    Hartford, ME
                                                        Board of            04220.
                                                        Selectmen, 1196
                                                        Main Street,
                                                        Hartford, ME
                                                        04220.
Massachusetts: Plymouth.........  Town of Wareham,     Mr. Derek           Town Hall, 54       https://msc.fema.gov/  Mar. 23, 2018........       255223
                                   (17-01-0909P).       Sullivan,           Marion Road,        portal/advanceSearch.
                                                        Administrator,      Wareham, MA 02571.
                                                        Town of Wareham,
                                                        54 Marion Road,
                                                        Wareham, MA 02571.
Montana:
    Big Horn....................  Unincorporated       The Honorable Chad  Big Horn County     https://msc.fema.gov/  Jun. 1, 2018.........       300143
                                   areas of Big Horn    Fenner, Chairman,   Health              portal/advanceSearch.
                                   County, (17-08-      Big Horn County     Department, 809
                                   0336P).              Board of            North Custer
                                                        Commissioners,      Avenue, Hardin,
                                                        P.O. Box 908,       MT 59034.
                                                        Hardin, MT 59034.
    Ravalli.....................  Unincorporated       The Honorable Greg  Ravalli County      https://msc.fema.gov/  May 14, 2018.........       300061
                                   areas of Ravalli     Chilcott,           Planning            portal/advanceSearch.
                                   County, (17-08-      Chairman, Ravalli   Department, 215 S
                                   0795P).              County Board of     4th Street, Suite
                                                        Commissioners,      F, Hamilton, MT
                                                        215 South 4th       59840.
                                                        Street, Suite A,
                                                        Hamilton, MT
                                                        59840.
North Carolina:
    Mecklenburg.................  Town of              The Honorable John  Planning            https://msc.fema.gov/  May 4, 2018..........       370478
                                   Huntersville, (17-   Aneralla, Mayor,    Department, 105     portal/advanceSearch.
                                   04-6263P).           Town of             Gilead Road, 3rd
                                                        Huntersville,       Floor,
                                                        P.O. Box 664,       Huntersville, NC
                                                        Huntersville, NC    28078.
                                                        28070.
    Mecklenburg.................  Town of              The Honorable John  Planning            https://msc.fema.gov/  May 18, 2018.........       370478
                                   Huntersville, (17-   Aneralla, Mayor,    Department, 105     portal/advanceSearch.
                                   04-6264P).           Town of             Gilead Road, 3rd
                                                        Huntersville,       Floor,
                                                        P.O. Box 664,       Huntersville, NC
                                                        Huntersville, NC    28078.
                                                        28070.
Rhode Island: Providence          City of Providence,  The Honorable       Department of       https://msc.fema.gov/  Mar. 16, 2018........       445406
                                   (17-01-1322P).       Jorge O. Elorza,    Inspection and      portal/advanceSearch.
                                                        Mayor, City of      Standards, 444
                                                        Providence, 25      Westminster
                                                        Dorrance Street,    Street,
                                                        Providence, RI      Providence, RI
                                                        02903.              02903.
Tennessee:
    Wilson......................  City of Lebanon,     The Honorable       Engineering         https://msc.fema.gov/  May 4, 2018..........       470208
                                   (17-04-4038P).       Bernie Ash,         Department, 200     portal/advanceSearch.
                                                        Mayor, City of      North Castle
                                                        Lebanon, 200        Heights Avenue,
                                                        North Castle        Suite 300,
                                                        Heights Avenue,     Lebanon, TN 37087.
                                                        Suite 100,
                                                        Lebanon, TN 37087.
    Wilson......................  Unincorporated       The Honorable       Wilson County       https://msc.fema.gov/  May 4, 2018..........       470207
                                   areas of Wilson      Randall Hutto,      Planning            portal/advanceSearch.
                                   County, (17-04-      Mayor, Wilson       Department, 228
                                   4038P).              County, 228 East    East Main Street
                                                        Main Street         Lebanon, TN 37087.
                                                        Lebanon, TN 37087.
Texas:
    Collin......................  City of Anna, (17-   The Honorable Nate  City Hall, 120      https://msc.fema.gov/  Apr. 16, 2018........       480132
                                   06-1736P).           Pike, Mayor, City   West 4th Street,    portal/advanceSearch.
                                                        of Anna, P.O. Box   Anna, TX 75409.
                                                        776, Anna, TX
                                                        75409.
    Collin......................  City of Murphy, (17- Mr. Mike Castro,    City Hall, 206      https://msc.fema.gov/  Apr. 6, 2018.........       480137
                                   06-1778P).           Ph.D., Manager,     North Murphy        portal/advanceSearch.
                                                        City of Murphy,     Road, Murphy, TX
                                                        206 North Murphy    75094.
                                                        Road, Murphy, TX
                                                        75094.
    Collin......................  Unincorporated       The Honorable       Collin County       https://msc.fema.gov/  Apr. 16, 2018........       480130
                                   areas of Collin      Keith Self,         Engineering         portal/advanceSearch.
                                   County, (17-06-      Collin County       Department, 4690
                                   1736P).              Judge, 2300         Community Avenue,
                                                        Bloomdale Road,     Suite 200,
                                                        Suite 4192,         McKinney, TX
                                                        McKinney, TX        75071.
                                                        75071.
    Dallas......................  City of Dallas, (17- The Honorable       Engineering         https://msc.fema.gov/  Mar. 26, 2018........       480171
                                   06-2978P).           Michael S.          Department, 320     portal/advanceSearch.
                                                        Rawlings, Mayor,    East Jefferson
                                                        City of Dallas,     Boulevard, Room
                                                        1500 Marilla        200, Dallas, TX
                                                        Street, Suite       75203.
                                                        5EN, Dallas, TX
                                                        75201.

    Denton......................  City of Carrollton,  The Honorable       City Hall, 1945     https://msc.fema.gov/  May 10, 2018.........       480167
                                   (17-06-2506P).       Kevin Falconer,     East Jackson        portal/advanceSearch.
                                                        Mayor, City of      Street,
                                                        Carrollton, P.O.    Carrollton, TX
                                                        Box 110535,         75006.
                                                        Carrollton, TX
                                                        75011.
    Denton......................  City of The Colony,  The Honorable Joe   City Hall, 6800     https://msc.fema.gov/  May 10, 2018.........       481581
                                   (17-06-2506P).       McCourry, Mayor,    Main Street, The    portal/advanceSearch.
                                                        City of The         Colony, TX 75056.
                                                        Colony, 6800 Main
                                                        Street, The
                                                        Colony, TX 75056.
    Harris and Montgomery.......  City of Houston,     The Honorable       Department of       https://msc.fema.gov/  Apr. 9, 2018.........       480296
                                   (17-06-2680P).       Sylvester Turner,   Public Works and    portal/advanceSearch.
                                                        Mayor, City of      Engineering, 1002
                                                        Houston, P.O. Box   Washington
                                                        1562, Houston, TX   Avenue, 3rd
                                                        77251.              Floor, Houston,
                                                                            TX 77002.
    Montgomery..................  City of Conroe, (17- The Honorable Toby  Engineering         https://msc.fema.gov/  Apr. 9, 2018.........       480484
                                   06-2100P).           Powell, Mayor,      Department, 300     portal/advanceSearch.
                                                        City of Conroe,     West Davis
                                                        300 West Davis      Street, Conroe,
                                                        Street, Conroe,     TX 77301.
                                                        TX 77301.
    Montgomery..................  City of Panorama     The Honorable Lynn  City Hall, 99       https://msc.fema.gov/  Apr. 9, 2018.........       481263
                                   Village, (17-06-     Scott, Mayor,       Hiwon Drive,        portal/advanceSearch.
                                   2100P).              City of Panorama    Panorama Village,
                                                        Village, 99 Hiwon   TX 77304.
                                                        Drive, Panorama
                                                        Village, TX 77304.
    Montgomery..................  Unincorporated       The Honorable       Montgomery County,  https://msc.fema.gov/  Apr. 9, 2018.........       480483
                                   areas of             Craig B. Doyal,     Permit              portal/advanceSearch.
                                   Montgomery County,   Montgomery County   Department, 501
                                   (17-06-2680P).       Judge, 501 North    North Thompson
                                                        Thompson Street,    Street, Suite
                                                        Suite 401,          100, Conroe, TX
                                                        Conroe, TX 77301.   77301.
    Rockwall....................  City of Rockwall,    The Honorable Jim   Public Works        https://msc.fema.gov/  May 14, 2018.........       480547
                                   (17-06-3552P).       Pruitt, Mayor,      Department, 385     portal/advanceSearch.
                                                        City of Rockwall,   South Goliad
                                                        385 South Goliad    Street, Rockwall,
                                                        Street, Rockwall,   TX 75087.
                                                        TX 75087.
    Smith.......................  City of Tyler, (17-  The Honorable       Development         https://msc.fema.gov/  May 10, 2018.........       480571
                                   06-1762P).           Martin Heines,      Services            portal/advanceSearch.
                                                        Mayor, City of      Department, 423
                                                        Tyler, P.O. Box     West Ferguson
                                                        2039, Tyler, TX     Street, Tyler, TX
                                                        75710.              75702.
    Tarrant.....................  City of Fort Worth,  The Honorable       Department of       https://msc.fema.gov/  May 17, 2018.........       480596
                                   (17-06-2261P).       Betsy Price,        Transportation      portal/advanceSearch.
                                                        Mayor, City of      and Public Works,
                                                        Fort Worth, 200     200 Texas Street,
                                                        Texas Street,       Fort Worth, TX
                                                        Fort Worth, TX      76102.
                                                        76102.
    Tarrant.....................  City of Fort Worth,  The Honorable       Department of       https://msc.fema.gov/  May 24, 2018.........       480596
                                   (17-06-4076P).       Betsy Price,        Transportation      portal/advanceSearch.
                                                        Mayor, City of      and Public Works,
                                                        Fort Worth, 200     200 Texas Street,
                                                        Texas Street,       Fort Worth, TX
                                                        Fort Worth, TX      76102.
                                                        76102.
    Tarrant.....................  City of Fort Worth,  The Honorable       Department of       https://msc.fema.gov/  May 24, 2018.........       480596
                                   (17-06-4079P).       Betsy Price,        Transportation      portal/advanceSearch.
                                                        Mayor, City of      and Public Works,
                                                        Fort Worth, 200     200 Texas Street,
                                                        Texas Street,       Fort Worth, TX
                                                        Fort Worth, TX      76102.
                                                        76102.
    Tarrant.....................  City of Haltom       The Honorable       Public Works        https://msc.fema.gov/  May 14, 2018.........       480599
                                   City, (17-06-        David Averitt,      Services            portal/advanceSearch.
                                   4081P).              Mayor, City of      Department, 4200
                                                        Haltom City, 5024   Hollis Street,
                                                        Broadway Avenue,    Haltom City, TX
                                                        Haltom City, TX     76111.
                                                        76117.
Utah: Washington................  City of St. George,  The Honorable Jon   City Hall, 175      https://msc.fema.gov/  May 25, 2018.........       490177
                                   (17-08-0793P).       Pike, Mayor, City   East 200 North,     portal/advanceSearch.
                                                        of St. George,      St. George, UT
                                                        175 East 200        84770.
                                                        North, St.
                                                        George, UT 84770.
Virginia: Stafford..............  Unincorporated       Mr. Thomas C.       Stafford County     https://msc.fema.gov/  May 31, 2018.........       510154
                                   areas of Stafford    Foley, Stafford     Department of       portal/advanceSearch.
                                   County, (17-03-      County              Planning and
                                   2308P).              Administrator,      Zoning, 1300
                                                        P.O. Box 339,       Courthouse Road,
                                                        Stafford, VA        Stafford, VA
                                                        22555.              22554.
--------------------------------------------------------------------------------------------------------------------------------------------------------

[FR Doc. 2018-05180 Filed 3-13-18; 8:45 am]
 BILLING CODE 9110-12-P


            EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR
             PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER

          EPA Registration Division contact: PV Shah,<PHONE_NUMBER>

Ecolab Inc.
IN-11113

EPA has received a pesticide petition (IN-11113) from Ecolab Inc., 655 Lone Oak Drive, Eagan, MN 55121 proposing, pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180.

to establish an exemption from the requirement of a tolerance for

      lactic acid (CAS Reg. No. 50-21-5) when used as an acidifier under 40 CFR 180.940(a) in pesticide formulations applied to food-contact surfaces in public eating places, dairy processing equipment, food-processing equipment and utensils at 10,000 parts per million (ppm). EPA has determined that the petition contains data or information regarding the elements set forth in section 408 (d)(2) of FDDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data supports granting of the petition. Additional data may be needed before EPA rules on the petition.

A. Residue Chemistry NA-Remove

      1. Plant metabolism.
      2. Analytical method. [NA-Remove]
      3. Magnitude of residues. [NA-Remove]

B. Toxicological Profile
Lactic acid is practically non-toxic to mammals, apart from irritation stemming from its
low pH. It is an endogenous compound produced in the mammalian system. L-lactic acid (lactate) is a product of fermentation in the muscles produced from pyruvate via lactate
dehydrogenase. Lactate is also generated from glucose under aerobic conditions in some tissues and cell types. L-Lactic acid is normally found in the blood and interstitial fluid of humans. In addition, lactic acid occurs naturally in several foods, primarily found in fermented milk products such as sour milk, cheese, buttermilk and yogurt. It also occurs naturally in meats,  fruits, tomato juice, beer, wine, molasses, blood and muscles of animals, and in the soil.

      1. Acute toxicity. The acute oral LD50 for -lactic acid was 3543  -  4936 mg/kg-bw for male and female Charles River rats, which places it in Acute Toxicity Category III for this endpoint. Clinical signs included lethargy, ataxia, prostration, irregular breathing, piloerection, squinting, lacrimation, salivation, crusty eyes and muzzle, loose stools, damp or yellow/brown stained fur and moribund. US EPA considered lactic acid Acute Toxicity Category III for dermal toxicity. The acute dermal LD50 of lactic acid in male and female New Zealand white rabbits was >2000 mg/kg bw following a 2-hour exposure to L(+)-lactic acid. No mortality or clinical signs of toxicity were seen. US EPA considered lactic acid Acute Toxicity Category IV for inhalation toxicity. The acute (4-hour) inhalation LC50 of lactic acid in male and female Fischer rats was >7.9 mg/L. Rats exposed via nose only demonstrated lethargy, rapid breathing, lacrimation, hunched posture, ruffled fur and unkempt appeared with soiled fur. By 24 hours, most animals appeared to have recovered from lethargy and unkempt fur although females (4/5) had ruffled and ungroomed fur until post-treatment day 4. One exposed female died on the 8[th] day post-treatment. No gross lesions were observed at necropsy.

      2. Genotoxicity. There is no evidence that lactic acid is genotoxic. The Cosmetic Ingredient Review (CIR) Expert Panel reviewed 15 mutagenicity and clastogenicity studies on lactic acid and ammonium, calcium, and sodium lactate. Results in all of these were negative. For example, in an Ames test in S. typhimurium strains TA92, TA1535, TA100, TA98, TA1537, and TA94, at a concentration of <10 mg/plate, 90.5% pure lactic acid did not induce reverse mutations with and without metabolic activation. In an in vitro chromosomal aberration study, Chinese hamster ovary K1 cells were exposed to 8-35 mM lactic acid in the presence or absence of metabolic activation. Lactic acid was not clastogenic with or without metabolic activation when the medium was neutralized to physiological pH 6.4 or when medium contained 30 mM HEPES as buffer. When the pH was not neutralized pseudo-positive reactions were observed. Cytotoxicity was noted at 14-35 mM, when pH was <5.8.

      3. Reproductive and developmental toxicity. Lactic acid was neither toxic to dams nor offspring when administered to pregnant Swiss mice via gavage at doses of 0 or 570 mg/kg bw/day during days 6-15 of gestation. Live fetuses were sexed, weighed and examined for morphological defects. The NOAEL for maternal and developmental toxicity was >570 mg/kg bw.

      4. Subchronic toxicity. The first in a series of three toxicity studies of lactic acid was a drinking water study in which F344 rats (5/sex/dose) received doses of 0.3%-5%, equivalent to approximately 0, 30, 60, 125, 250 or 500 mg/kg-bw/day, for 13 weeks. Effects reported were a slightly decreased body weight gain (<10%) at all doses compared to control group. Some changes in hematological and biochemical parameters were observed but no severe toxicological findings were reported in the histological examination in any dose group. The NOAEL was >500 mg/kg bw/day.

In the second study, F344 rats (5/sex/dose) received a synthetic diet containing 0, 5, 10, 20, or 30% calcium lactate. Body weight gain was decreased at the highest dose compared to control rats. The histological exam showed calcium salt deposition in the kidneys (nephrocalcinosis) in all groups including the controls; the degree of calcification was dose dependent, and was attributed to the low calcium/phosphorus ratio of the synthetic diet.

In the third study, rats were given either the basic or synthetic diet for 8 weeks. Calcium deposits in kidneys were observed only in the group given the synthetic diet and it was concluded that this effect was due to low Ca/P ratio (less than 1) of that diet.

A 14-week study was carried out in 8 male and 7 female Syrian hamsters per group. Group 1, the control group, received Diet 1: 20% sucrose plus pure water to drink. Group 2 received Diet 1 with 0.057 mL of 80%-pure lactic acid per 100 g of feed and pure water to drink. Group 3 received Diet 1, and drinking water containing 0.05% v/v 80%-pure lactic acid. Animals of groups 2 & 3 ingested the same amount lactic acid. After exposure, animals were sacrificed and autopsied. There were no differences in appearance or growth rate between the groups, and no gross changes were observed at necropsy.

No overt toxic effects were observed in pigs given approximately 3600 -18,000 mg/kg lactic acid in feed or water for up to 5 months. No further information was available on this study.

A group of white rats was fed 4 mL of 10% lactic acid mixed with 20 g of feed each day for 90 days. This dose was approximately 2042 mg/kg/day. A concurrent control received no lactic acid. No differences in appearance, gross observations at necropsy, or organ weights were observed between the test and control animals. Changes in blood carbon dioxide were slight.

F344 rats (50/sex/dose) received calcium lactate in the drinking water at levels of 0, 2.5 or 5% for 2 years. According to the Joint FAO/WHO Expert Committee on Food Additives, this provided doses of 0, 2500, and 5000 mg/kg bw per day, respectively, of calcium lactate. Rats were then given distilled water for a recovery period of 9 weeks. At week 113, all surviving animals were killed and autopsied. Gross and microscopic examinations were carried out for presence of non-neoplastic and neoplastic lesions. High-dose male and female rats showed a significant reduction (13%) in mean body weight gain. A significant dose-dependent increase was observed in the relative brain weights of both male and female rats without accompanying histological change. Study authors concluded this effect was a result of the decrease in body weight gain. There was no further evidence of organ-specific toxicity and there was no evidence of carcinogenicity. Based on body weight gain reduction, the NOAEL of this study is 2500 mg/kg bw/day calcium lactate, which is equivalent to 1032 mg/kg bw/day lactic acid.

      5. Chronic toxicity. The authors of the 90-day study described in the previous paragraph found no evidence of carcinogenicity in F355 rats in the 2-year drinking water study at doses up to 5000 mg/kg/day. Furthermore, lactic acid is an endogenous compound produced in the mammalian system and lactate is a product of anaerobic and aerobic respiration. It is not likely to be carcinogenic.

      6. Animal metabolism. Animals readily absorb both isomers of lactic acid or lactate from the gastrointestinal tract and have the capacity to completely metabolize both. In rats intubated with DL- sodium lactate containing radiolabeled C in the carboxyl position, an average of 20% of the administered radioactivity was expired as CO2 during the 2.5 hours following administration. Lactic acid/lactate is a product of fermentation in the muscles produced from pyruvate via lactate dehydrogenase. Lactic acid produced during anaerobic metabolism enters the lactic acid (Cori) cycle, diffusing into blood and then to the liver where it is converted back into pyruvate by lactic acid dehydrogenase. Lactate is also generated from glucose under aerobic conditions in some tissues and cell types.

      7. Metabolite toxicology. NA Remove

      8. Endocrine disruption. Toxicity related to endocrine disruption was not observed in the lactic acid database. As the scientific knowledge develops, screening of additional compounds may be added to the Endocrine Disruptor Screening Program (EDSP). When additional screening and/or testing is conducted lactic acid may be the focus of screening and/or testing to better characterize effects related to endocrine disruption.

C. Aggregate Exposure

      1. Dietary exposure. The estimated dietary exposure to lactic acid was determined using the FDA method in Sanitizing Solutions: Chemistry Guidelines for Food Additive Petitions, which is recommended for estimating dietary exposure to components of food contact sanitizing solution formulations intended for uses described under section 180.940a. Assumptions made in this model are:
:: 1 mg/cm² of product residue is present on the surface
:: The surface work area is 2000 cm2
:: 100% of residues transfer from the surface into food consumed by each individual daily
:: 100% of food contacts treated surfaces
:: Body weight default is 70 kg (adult) and 12.6 kg (1-2 yr old child)

The Estimated Daily Intake (EDI; mg/kg bw/day) was calculated to be 0.286 mg/kg bw/day for an adult and 1.59 mg/kg bw/day for a 1-2 year old child. This is 0.29% of the chronic population adjusted dose (cPAD) for an adult and 1.6% for a 1-2 year old child.

      i. Food. The approximate concentration of lactic acid in the American diet is 20.8 mg/kg/day.

      ii. Drinking water. Lactic acid is not expected to be present in drinking water.

      2. Non-dietary exposure. Lactic acid is a component of cosmetics.

D. Cumulative Effects Section 408(b)(2)(D) (9v) of the FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, 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." EPA has not made a common mechanism of toxicity finding as to lactic acid and other compounds. Lactic acid does not produce toxic metabolites in common with other substances.

E. Safety Determination

      1. U.S. population. There is a reasonable certainty that no harm to humans will result from the use of lactic acid as an inert ingredient in antimicrobial pesticide products. The limit dose NOAEL of 1000 mg/kg/day was used to represent a substance that is essentially nontoxic because lactic acid is endogenous and has been consumed by people for centuries as part of the diet. This value was used to derive the chronic population adjusted dose (cPAD) along with a safety factor of 10 to account for sensitivity in the population. The resulting cPAD is 100 mg/kg/day. The estimated dietary exposure from food to lactic acid, assuming 100% of residues transfer from the surface into food and 100% of food contacts treated surfaces, is 0.29% of the cPAD for a 70-lb adult, well below any level of potential concern.

      2. Infants and children. There is a reasonable certainty that no harm to infants and children will result from the use of lactic acid as an inert ingredient in antimicrobial pesticide products. Lactic acid was not toxic to the development of mice when gestating mothers received 570 mg/kg bw/day lactic acid during gestation days 6-15. Thus at this time there is no concern for potential sensitivity to infants and children, and therefore the default 10X FQPA safety factor may be reduced to 1X.

F. International Tolerances

NA-Remove


[Federal Register: November 24, 2008 (Volume 73, Number 227)]
[Notices]
[Page 71082-71083]
[DOCID:fr24no08-154]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-58968; File No. SR-NYSEArca-2008-111]

Self-Regulatory Organizations; NYSE Arca, Inc.; Order Granting
Accelerated Approval of Proposed Rule Change To Amend NYSE Arca
Equities Rule 5.2(j)(6)(v) in Order To Add the CBOE Volatility
Index[reg] (``VIX[reg]'') Futures (``VIX Futures'') to the Definition
of Futures Reference Asset

November 17, 2008.
    On October 17, 2008, NYSE Arca, Inc. (``NYSE Arca'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') a proposed rule change pursuant to Section 19(b)(1) of
the Securities Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 \2\
thereunder to amend NYSE Arca Equities Rule 5.2(j)(6)(v) to add the
CBOE Volatility Index[reg] (``VIX[reg]'') Futures (``VIX Futures'') to
the definition of ``Futures Reference Asset.'' The proposed rule change
was published for comment in the Federal Register on October 30, 2008
for a 15-day comment period.\3\ The Commission received no comment
letters regarding the proposal. This order approves 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. 58855 (October 24,
2008), 73 FR 64647 (``Notice'').
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    The Commission has previously approved the listing and trading,
pursuant to NYSE Arca Equities Rule 5.2(j)(6), including listing
pursuant to Rule 19b-4(e) under the Act (``Rule 19b-4(e)''), of Index-
Linked Securities, which term currently is defined in NYSE Arca
Equities Rule 5.2(j)(6) to encompass Equity Index-Linked Securities,
Commodity-Linked Securities, Currency-Linked Securities, Fixed Income
Index-Linked Securities, Futures-Linked Securities and Multifactor
Index-Linked Securities.\4\ The Exchange proposes to amend NYSE Arca
Equities Rule 5.2(j)(6)(v) to add the VIX Futures as an underlying
financial instrument of a Futures-Linked Security and include VIX
Futures within the definition of a Futures Reference Asset.\5\
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    \4\ See Securities Exchange Act Release Nos. 56637 (October 10,
2007), 72 FR 58704 (October 16, 2007) (SR-NYSEArca-2007-92) and
57505 (March 14, 2008), 73 FR 15550 (March 24, 2008) (SR-NYSEArca-
2008-20).
    \5\ For more details on the VIX and VIX Futures, see Notice,
supra note 3.
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    After careful consideration, the Commission finds 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
\6\ and, in particular, the requirements of Section 6 of the Act.\7\
Specifically, the Commission finds that the proposed rule change is
consistent with Section 6(b)(5) of the Act,\8\ which requires, among
other things, that the rules of a national securities exchange be
designed to prevent fraudulent and manipulative acts and practices, to
promote just and equitable principles of trade, to foster cooperation
and coordination with persons engaged in facilitating transactions in
securities, to remove impediments to and perfect the mechanisms 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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    \6\ In approving this proposed rule change, the Commission has
considered the proposed rule's impact on efficiency, competition,
and capital formation. 15 U.S.C. 78c(f).
    \7\ 15 U.S.C. 78f.
    \8\ 15 U.S.C. 78f(b)(5).
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    The Commission notes that it has previously approved NYSE Arca
Equities Rule 5.2(j)(6) to list and trade Index-Linked Securities,
including Futures-Linked Securities on the Exchange pursuant to Rule
19b-4(e).\9\ The Exchange represented that any securities it would list
and/or trade pursuant to proposed amended NYSE Arca Equities Rule
5.2(j)(6) would continue to comply with all Exchange rules applicable
to the listing and trading of Index Linked Securities. Therefore, the
Commission does not believe that the proposed rule change raises any
novel regulatory issues and hereby approves the proposed rule change.
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    \9\ See, supra, note 4.
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    In addition, the Commission finds good cause, pursuant to Section
19(b)(2) of the Act,\10\ for approving the proposed rule change prior
to the thirtieth day after the date of publication of notice in the
Federal Register. The Commission believes that accelerating approval of
the proposed rule change would facilitate the listing and trading of
additional Futures-Linked Securities, offering greater choices to
market participants, while still protecting investors. For the reasons
discussed above, the Commission does not believe that the proposed rule
change raises any new regulatory issues.
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    \10\ 15 U.S.C. 78s(b)(2).
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    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\11\ that the proposed rule change (SR-NYSEArca2008-111) is hereby
approved on an accelerated basis.
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    \11\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\12\
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    \12\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Acting Secretary.
[FR Doc. E8-27883 Filed 11-21-08; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register: April 24, 2007 (Volume 72, Number 78)]
[Notices]
[Page 20395-20396]
[DOCID:fr24ap07-113]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-55642; File No. SR-NASDAQ-2006-032]

Self-Regulatory Organizations; The NASDAQ Stock Market LLC;
Notice of Filing of Amendment No. 3 and Order Granting Accelerated
Approval of a Proposed Rule Change, as Modified by Amendments No. 1, 2,
and 3 Thereto, To Revise The Nasdaq Capital Market Listing Requirements

April 18, 2007.

I. Introduction

    On August 23, 2006, 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 revise certain listing requirements applicable
to the Nasdaq Capital Market (``NCM''). On August 28, 2006, Nasdaq
filed Amendment No. 1 (``Amendment No. 1'') to the proposed rule
change.\3\ The proposed rule change, as amended by Amendment No. 1, was
published for comment in the Federal Register on September 5, 2006.\4\
The Commission received no comments on the proposal, as amended by
Amendment No. 1. On December 4, 2006, Nasdaq filed Amendment No. 2
(``Amendment No. 2'') to the proposed rule change.\5\ On February 15,
2007, Nasdaq filed Amendment No. 3 (``Amendment No. 3'') to the
proposed rule change.\6\ This order provides notice of Amendment No. 3
and approves the proposed rule change on an accelerated basis, as
amended.
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    \1\15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b 4.
    \3\ In Amendment No. 1, Nasdaq made clarifying changes to the
rule text in the NCM convertible debt listing standards. Nasdaq also
made clarifying changes to the purpose section regarding convertible
debt, rights and warrants, and non-Canadian foreign securities and
American Depository Receipts.
    \4\ See Securities Exchange Act Release No. 54378 (August 28,
2006), 71 FR 52351 (September 5, 2006) (``Notice'').
    \5\ In Amendment No. 2, Nasdaq made minor clarifying changes to
the purpose section to explain the application of the new NCM
listing standards as they relate to the grace period for non-
compliance with the bid requirement pursuant to Nasdaq Rules
4310(c)(8)(D), 4320(e)(2)(E)(ii), and 4450(i). This is a technical
amendment and is not subject to notice and comment.
    \6\ In Amendment No. 3, Nasdaq amended its initial and
continuing listing standards for convertible debt to require that
current last sale information be available in the United States for
the underlying security into which a convertible debt issue is
convertible.
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II. Discussion

    Nasdaq proposes to increase the initial and continued listing
requirements for companies seeking to list, or that are already listed,
on the NCM, as set forth in Nasdaq Rule 4310 (for domestic and Canadian
securities) and Nasdaq Rule 4320 (for non-Canadian foreign securities
and American Depositary Receipts).\7\
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    \7\ For a full description of the proposed rule change, see
Notice, supra note 4 and Amendments No. 2 and 3, supra notes 5 and
6.
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    The Commission finds that these proposed changes are consistent
with Section 6(b) of the Act,\8\ and the rules and regulations
thereunder applicable to a national securities exchange.\9\ In
particular, the Commission finds that these proposed rule changes are
consistent with Section 6(b)(5) of the Act,\10\ which requires, among
other things, that the Exchange's rules be designed 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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    \8\ 15 U.S.C. 78f(b).
    \9\ In approving this proposal, as amended, the Commission has
considered the proposed rule's impact on efficiency, competition,
and capital formation. 15 U.S.C. 78c(f).
    \10\ 15 U.S.C. 78f(b)(5).
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    The development and enforcement of adequate standards governing the
initial listing and maintenance of listing of securities is an activity
of critical importance to financial markets and the investing public.
Listing standards serve as a means for a marketplace to screen issuers
and to provide listed status only to bona fide companies with
sufficient float, investor base, and trading interest to maintain fair
and orderly markets. Once an issuer has been approved for initial
listing, the maintenance criteria allow a marketplace to monitor the
status and trading characteristics of that issuer to ensure that it
continues to meet standards for market depth and liquidity.
    The changes to the continued listing requirements will be effective
30 days after the proposed rule change is approved by the Commission.
Nasdaq represents that as of February 9, 2006, it is not aware of any
issuer currently listing on NCM that would fail to meet the new
continued listing requirements.\11\ In the case of

companies applying for initial listing, the new requirements will be
effective immediately upon Commission approval of this proposed rule
change for companies that applied after August 23, 2006, the date this
proposed rule change was filed with the Commission. Companies that
applied for listing prior to August 23, 2006 would be allowed to
qualify under the prior standards, provided that they complete the
listing process not later than 30 days after the proposed rule change
is approved by the Commission. The Commission believes this
implementation schedule is reasonable, and provided adequate notice to
prospective applicants for listing.
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    \11\ See letter from Arnold Golub, Associate General Counsel,
Nasdaq, to Elizabeth K. King, Associate Director, Division
(``Division''), Commission on February 12, 2007; see also letter
from Arnold Golub, Associate General Counsel, Nasdaq, to Elizabeth
K. King, Associate Director, Division, Commission on November 7,
2006.
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III. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning Amendment No. 3, including whether Amendment No. 3
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 No. SR-NASDAQ-2006-032 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NASDAQ-2006-032. 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 Room. Copies of such
filing also will be available for inspection and copying at the
principal office of the Nasdaq. 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-NASDAQ-2006-032 and should be submitted on or before May
15, 2007.

IV. Accelerated Approval

    Pursuant to Section 19(b)(2) of the Act,\12\ the Commission finds
good cause to approve the proposal, as amended, prior to the thirtieth
day after the amended proposal is published for comment in the Federal
Register. Amendment No. 3 requires that convertible debt securities
listed on the NCM have current last sale information available in the
United States for the underlying security into which a convertible debt
issue is convertible. Accelerating approval of the proposal, as
modified by Amendment No. 3, would avoid delay in strengthening the
initial and continued listing standards of the NCM, thereby benefiting
investors and the public. Accordingly, the Commission finds good cause
to accelerate approval of the amended proposal prior to the thirtieth
day after publication in the Federal Register.
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    \12\ 15 U.S.C. 78s(b)(2).
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V. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\13\ that the proposed rule change (SR-NASDAQ-2006-032), as
modified by Amendments No. 1, 2, and 3, is approved on an accelerated
basis.
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    \13\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\14\
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    \14\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
 [FR Doc. E7-7729 Filed 4-23-07; 8:45 am]

BILLING CODE 8010-01-P