[Federal Register: February 4, 2009 (Volume 74, Number 22)]
[Rules and Regulations]
[Page 5984]
[DOCID:fr04fe09-3]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2008-1256]

Drawbridge Operation Regulation: Upper Mississippi River, Keokuk,
IA, Activity Identifier; Repair and Maintenance

AGENCY: Coast Guard, DHS.

ACTION: Notice of temporary deviation from regulations.

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SUMMARY: The Commander, Eighth Coast Guard District has issued a
temporary deviation from the regulation governing the operation of the
Keokuk Drawbridge, across the Upper Mississippi River, mile 364.0, at
Keokuk, Iowa. The deviation is necessary to allow time for performing
needed maintenance and repairs to the bridge. This deviation allows the
bridge to open on signal if at least 24 hours advance notice is given
from 12:01 a.m., January 12, 2009 until 9 a.m., February 8, 2009.

DATES: This temporary deviation is effective from 12:01 a.m., January
12, 2009 until 9 a.m., February 8, 2009.

ADDRESSES: Documents indicated in this preamble as being available in
the docket are part of docket USCG-2008-1256 and are available online
at www.regulations.gov. They are also available for inspection or
copying at two locations: The Docket Management Facility (M-30), U.S.
Department of Transportation, West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays, and the Robert A.
Young Federal Building, Room 2.107F, 1222 Spruce Street, St. Louis, MO
63103-2832, between 8 a.m. and 4 p.m., Monday through Friday, except
Federal holidays.

FOR FURTHER INFORMATION CONTACT: Roger K. Wiebusch, Bridge
Administrator,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The City of Keokuk, Iowa requested a
temporary deviation for the Keokuk Drawbridge, across the Upper
Mississippi, mile 364.0, at Keokuk, Iowa to open on signal if at least
24 hours advance notice is given in order to facilitate needed bridge
maintenance and repairs. The Keokuk Drawbridge currently operates in
accordance with 33 CFR 117.5, which states the general requirement that
drawbridges shall open promptly and fully for the passage of vessels
when a request to open is given in accordance with the subpart. In
order to facilitate the needed bridge work, the drawbridge must be kept
in the closed-to-navigation position. This deviation allows the bridge
to open on signal if at least 24 hours advance notice is given from
12:01 a.m., January 12, 2009 until 9 a.m., February 8, 2009.
    There are no alternate routes for vessels transiting this section
of the Upper Mississippi River.
    The Keokuk Drawbridge, in the closed-to-navigation position,
provides a vertical clearance of 25.2 feet above normal pool.
Navigation on the waterway consists primarily of commercial tows and
recreational watercraft. This temporary deviation has been coordinated
with waterway users. No objections were received.
    In accordance with 33 CFR 117.35(e), the drawbridge must return to
its regular operating schedule immediately at the end of the designated
time period. This deviation from the operating regulations is
authorized under 33 CFR 117.35.

    Dated: January 7, 2009.
Roger K. Wiebusch,
Bridge Administrator.
[FR Doc. E9-2316 Filed 2-3-09; 8:45 am]

BILLING CODE 4910-15-P


[Federal Register Volume 82, Number 181 (Wednesday, September 20, 2017)]
[Rules and Regulations]
[Pages 43840-43842]
[FR Doc No: 2017-19950]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 95

[Docket No. 31156; Amdt. No. 535]

IFR Altitudes; Miscellaneous Amendments

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: This rule adopts miscellaneous amendments to the required IFR
(instrument flight rules) altitudes and changeover points for certain
Federal airways, jet routes, or direct routes for which a minimum or
maximum en route authorized IFR altitude is prescribed. This regulatory
action is needed because of changes occurring in the National Airspace
System. These changes are designed to provide for the safe and
efficient use of the navigable airspace under instrument conditions in
the affected areas.

DATES: Effective 0901 UTC, October 12, 2017.

FOR FURTHER INFORMATION CONTACT: Thomas J Nichols, Flight Procedure
Standards Branch (AMCAFS-420), Flight Technologies and Programs
Division, Flight Standards Service, Federal Aviation Administration,
Mike Monroney Aeronautical Center, 6500 South MacArthur Blvd., Oklahoma
City, OK 73169 (Mail Address: P.O. Box 25082 Oklahoma City, OK 73125)
telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: This amendment to part 95 of the Federal
Aviation Regulations (14 CFR part 95) amends, suspends, or revokes IFR
altitudes governing the operation of all aircraft in flight over a
specified route or any portion of that route, as well as the changeover
points (COPs) for Federal airways, jet routes, or direct routes as
prescribed in part 95.

The Rule

    The specified IFR altitudes, when used in conjunction with the
prescribed changeover points for those routes, ensure navigation aid
coverage that is adequate for safe flight operations and free of
frequency interference. The reasons and circumstances that create the
need for this amendment involve matters of flight safety and
operational efficiency in the National Airspace System, are related to
published aeronautical charts that are essential to the user, and
provide for the safe and efficient use of the navigable airspace. In
addition, those various reasons or circumstances require making this
amendment effective before the next scheduled charting and publication
date of the flight information to assure its timely availability to the
user. The effective date of this amendment reflects those
considerations. In view of the close and immediate relationship between
these regulatory changes and safety in air commerce, I find that notice
and public procedure before adopting this amendment are impracticable
and contrary to the public interest and that good cause exists for
making the amendment effective in less than 30 days.

Conclusion

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore--(1) is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a regulatory evaluation as the
anticipated impact is so minimal. For the same reason, the FAA
certifies that this amendment will not have a significant economic
impact on a substantial number of small entities under the criteria of
the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 95

    Airspace, Navigation (air).

    Issued in Washington, DC, on September 8, 2017.
John Duncan,
Director, Flight Standards Service.

Adoption of the Amendment

    Accordingly, pursuant to the authority delegated to me by the
Administrator, part 95 of the Federal Aviation Regulations (14 CFR part
95) is amended as follows effective at 0901 UTC, October 12, 2017.

0
1. The authority citation for part 95 continues to read as follows:

     Authority: 49 U.S.C. 106(g), 40103, 40106, 40113, 40114, 40120,
44502, 44514, 44719, 44721.

0
2. Part 95 is amended to read as follows:

                                  Revisions to IFR Altitudes & Changeover Point
                                [Amendment 535 Effective Date, October 12, 2017]
----------------------------------------------------------------------------------------------------------------
                     From                                         To                        MEA          MAA
----------------------------------------------------------------------------------------------------------------
                                    Sec.   95.4000 High Altitude RNAV Routes
                                          Sec.   95.4039 RNAV Route Q39
----------------------------------------------------------------------------------------------------------------
             Is Amended By Adding

CLAWD, NC WP..................................  TARCI, WV FIX.........................      * 18000        45000
    * 18000-GNSS MEA
    * DME/DME/IRU MEA
TARCI, WV FIX                                   ASERY, WV WP..........................      * 18000        45000
    * 18000-GNSS MEA
    * DME/DME/IRU MEA

             Is Amended to Delete

CLAWD, NC WP..................................  WISTA, WV WP..........................      * 18000        45000
    * 18000-GNSS MEA
    * DME/DME/IRU MEA
----------------------------------------------------------------------------------------------------------------
                                          Sec.   95.4067 RNAV Route Q67
----------------------------------------------------------------------------------------------------------------
             Is Amended by Adding

JONEN, KY WP..................................  DARYN, WV WP..........................      * 18000        45000
    * 18000-GNSS MEA
    * DME/DME/IRU MEA
             Is Amended to Delete

JONEN, KY WP..................................  COLTZ, OH FIX.........................      * 18000        45000
    * 18000-GNSS MEA
    * DME/DME/IRU MEA
----------------------------------------------------------------------------------------------------------------

               From                           To                 MEA
------------------------------------------------------------------------
                     Sec.   95.6001 Victor Routes-U.S
     Sec.   95.6006 VOR Federal Airway V6 Is Amended to Read in Part
------------------------------------------------------------------------
IOWA CITY, IA VOR/DME............  DAVENPORT, IA VORTAC....         2700
------------------------------------------------------------------------
        Sec.   95.6007 VOR Federal Airway V7 Is Amended to Delete
------------------------------------------------------------------------
MUSCLE SHOALS, AL VORTAC.........  GILLE, AL FIX...........         2500
GILLE, AL FIX....................  GRAHAM, TN VORTAC.......       * 3000
    * 2400-MOCA
GRAHAM, TN VORTAC................  VALER, TN FIX...........         3000
VALER, TN FIX....................  CENTRAL CITY, KY VORTAC.       * 3000
    * 2200-MOCA
------------------------------------------------------------------------
    Sec.   95.6028 VOR Federal Airway V28 Is Amended to Read in Part
------------------------------------------------------------------------
HAIRE, CA FIX....................  * LINDEN, CA VOR/DME....      ** 3000
    * 4000-MCA...................  LINDEN, CA VOR/DME, NE
                                    BND
    ** 2100-MOCA
SPOOK, CA FIX....................  RICHY, CA FIX...........      * 15000
    * 12000-MOCA
------------------------------------------------------------------------
    Sec.   95.6059 VOR Federal Airway V59 Is Amended to Read in Part
------------------------------------------------------------------------
WARDO, WV FIX....................  * EDSOE, WV FIX.........         3000
    * 3500-MRA
    * EDSOE, WV FIX                PARKERSBURG, WV VORTAC..         3000
    * 3500-MRA
------------------------------------------------------------------------
       Sec.   95.6067 VOR Federal Airway V67 Is Amended to Delete
------------------------------------------------------------------------
SHELBYVILLE, TN VOR/DME..........  GRAHAM, TN VORTAC.......       * 4000
    * 2500-MOCA
GRAHAM, TN VORTAC................  LANKY, TN FIX...........       * 4000
    * 2200-MOCA
LANKY, TN FIX....................  CUNNINGHAM, KY VOR/DME..       * 3000
    * 2200-MOCA
------------------------------------------------------------------------
    Sec.   95.6088 VOR Federal Airway V88 Is Amended to Read in Part
------------------------------------------------------------------------
WACCO, MO FIX....................  * QUALM, MO FIX.........      ** 3700
    * 3700-MCA                     QUALM, MO FIX, W BND
    ** 3000-MOCA
------------------------------------------------------------------------
    Sec.   95.6113 VOR Federal Airway V113 Is Amended to Read in Part
------------------------------------------------------------------------
MODESTO, CA VOR/DME..............  * LINDEN, CA VOR/DME....         2000
    * 4000-MCA...................  LINDEN, CA VOR/DME, NE
                                    BND
KATSO, CA FIX....................  * SPOOK, CA FIX.........     ** 13000
    * 15000-MCA..................  SPOOK, CA FIX, N BND
    ** 12100-MOCA................  SPOOK, CA FIX; RICHY, CA      * 15000
                                    FIX.
    * 12000-MOCA
------------------------------------------------------------------------

    Sec.   95.6115 VOR Federal Airway V115 Is Amended to Read in Part
------------------------------------------------------------------------
CHARLESTON, WV VORTAC............  PARKERSBURG, WV VORTAC..         3000
------------------------------------------------------------------------
    Sec.   95.6119 VOR Federal Airway V119 Is Amended to Read in Part
------------------------------------------------------------------------
HENDERSON, WV VORTAC.............  * JACEE, WV FIX.........         2700
    * 3800-MRA
------------------------------------------------------------------------
    Sec.   95.6190 VOR Federal Airway V190 Is Amended to Read in Part
------------------------------------------------------------------------
WACCO, MO FIX....................  QUALM, MO FIX...........      ** 3700
    * 3700-MCA...................  QUALM, MO FIX, W BND
    ** 3000-MOCA
------------------------------------------------------------------------
    Sec.   95.6195 VOR Federal Airway V195 Is Amended to Read in Part
------------------------------------------------------------------------
* TOMAD, CA FIX..................  ** YAGER, CA FIX........    *** 11000
    * 7000-MRA
    ** 7700-MCA..................  YAGER, CA FIX, E BND
    ** 8300-MOCA
------------------------------------------------------------------------
    Sec.   95.6216 VOR Federal Airway V216 Is Amended to Read in Part
------------------------------------------------------------------------
IOWA CITY, IA VOR/DME............  LOTTE, IA FIX...........       * 3500
    * 2600-MOCA
------------------------------------------------------------------------
    Sec.   95.6513 VOR Federal Airway V513 Is Amended to Read in Part
------------------------------------------------------------------------
NEW HOPE, KY VOR/DME.............  LOUISVILLE, KY VORTAC...         2700
------------------------------------------------------------------------

[FR Doc. 2017-19950 Filed 9-19-17; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 76, Number 225 (Tuesday, November 22, 2011)]
[Notices]
[Pages 72231-72233]
[FR Doc No: 2011-30057]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-65763; File No. SR-BX-2011-077]

Self-Regulatory Organizations; NASDAQ OMX BX, Inc.; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change To Add Good-
Till-Cancelled and Discretionary Orders

November 16,2011.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 \2\ thereunder, notice is hereby given
that on November 10, 2011, NASDAQ OMX BX, Inc. (``Exchange'' or ``BX'')
filed with the Securities and Exchange Commission (``SEC'' or
``Commission'') the proposed rule change as described in Items I and
II, 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\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

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

    BX is filing with the Commission a proposed rule change to adopt
the following two new Time in Force conditions in Rule 4751(h): System
Hours Good-till-Cancelled (``SGTC'') and Market Hours GTC (``MGTC''),
as described below. BX also proposes to amend Rules 4751(f), 4755,
Order Entry Parameters, and 4756, Entry and Display of Quotes and
Orders, to add Discretionary Orders.
    The text of the proposed rule change is available at http://nasdaqomxbx.cchwallstreet.com/, at BX's principal office, 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 Exchange 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 Exchange 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, Proposed Rule Change

1. Purpose
    The purpose of the proposed rule change is to add some new features
to the BX Equities Market, as described below.
Time in Force
    Currently, Rule 4751(h) provides that the term ``Time in Force''
means the period of time that the System will hold an order for
potential execution. Time in force conditions, which are listed in Rule
4755(a)(1)(A), currently include System Hours Expire Time (``SHEX''),
System Hours Day (``SDAY''), System Hours Immediate or Cancel
(``SIOC''), or Good-til-Market Close ``GTMC'').
    At this time, two new designations are being added. First, BX
proposes to adopt in Rule 4751(h)(3) [sic] to state that ``System Hours
Good-till-Cancelled'' or ``SGTC'' shall mean, for orders so designated,
that if after entry into the System, the order is not fully executed,
the order (or unexecuted portion thereof) shall remain available for
potential display and/or execution from 7 a.m. until 7 p.m. Eastern
Time unless cancelled by the entering party, or until 1 year after
entry, whichever comes first.
    Second, BX proposes to adopt, as Rule 4751(h)(7), ``Market Hours
GTC'' or ``MGTC,'' which shall mean for orders so designated, that if
after entry into System, the order is not fully executed, the order (or
unexecuted portion thereof) shall remain available for potential
display and/or execution unless cancelled by the entering party, or
until 1 year after entry, whichever comes first. MGTC Orders shall be
available for entry from 7 a.m. until 7 p.m. Eastern Time and for
potential execution from 9:30 a.m. until 4 p.m. Eastern Time.
    BX also proposes to amend Rule 4755(a)(1)(A) to add SGTC and MGTC
designations to this rule, which lists the various Time in Force
designations available. BX proposes to delete the sentence in Rule
4755(a)(1)(B) that provides that, in addition to such other
designations as may be chosen by a participant, all System orders must
be entered with a Time in Force of System Hours Immediate or Cancel or
designated as a Pegged Order, an Intermarket Sweep Order, a Price to
Comply order, or a Price to Comply Post order. With the addition of two
GTC designations, this provision is obsolete.
    BX believes that these two new Time in Force designations should be
useful to BX participants and may attract additional business to BX.
Discretionary Orders
    BX also proposes to adopt a new order type, Discretionary Orders,
which are orders that have a displayed price and size, as well as a
non-displayed discretionary price range, at which the entering party,
if necessary, is also willing to buy or sell. The non-displayed trading
interest is not entered into the System book but is, along with the
displayed size, converted to an IOC buy (sell) order priced at the
highest (lowest) price in the discretionary price range when displayed
shares become available or an execution takes place at any price within
the discretionary price range. The generation of this IOC order is
triggered by the cancellation of the open shares of the Discretionary
Order. If more than one Discretionary Order is available for conversion
to an IOC order, the system will convert all such orders at the same
time and priority will be given to the first IOC order(s) that reaches
the trading interest on the other side of the market. If an IOC order
is not executed in full, the unexecuted portion of the order is
automatically re-posted and displayed in the System book with a new
time stamp, at its original displayed price, and with its non-displayed
discretionary price range.
    For example, the market on the BX is $10.00 x $10.05 and Order A is
entered as a bid for 1,000 shares at $10.00 with a discretionary price
of $10.03. It posts on the book at $10.00. Order B is an offer for 500
shares at $10.03 which posts on the book. Order A is cancelled by the
system and a 500 share IOC (Order C) is sent into the system to take
out Order B at $10.03. Orders C and B trade at $10.03, after which the
remaining 500 shares of the original discretionary order (Order A) post
on the book at $10.00.
    The Exchange proposes to adopt the definition of Discretionary
Orders as Rule 4751(f)(1) in the Definitions section where order types
are defined. In addition, the Exchange proposes to add Discretionary
Orders to Rule 4755(a)(1)(B), which lists various order types, and Rule
4756(c)(3)(B), which governs the display of orders. With respect to the
display of orders, Rule 4756 generally states that the System will
display the aggregate size of all quotes and orders at the best price
to buy and sell resident in the System. Discretionary Orders will be
added as an exception, similar to Reserve Size, because Discretionary
Orders, by definition, have a non-displayed discretionary price range.
    BX believes that Discretionary Orders are useful to market
participants, because this order type enables participants to provide
price improvement beyond the price at which they are willing to submit
an order today; when the price of an order is displayed, the result may
be that the market has moved, reflecting that order. Some market
participants prefer not to advertise their order but are willing to
provide price improvement.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the provisions of Section 6 of the Act,\3\ in general, and with
Sections 6(b)(5) of the Act,\4\ in particular, in that the proposal is
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 regulating, clearing,
settling, processing information with respect to, and facilitating
transactions in securities, 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, because it
offers BX participants an additional Time in Force to better manage
their orders and risk, which should, in turn, attract additional orders
to BX and enhance the Exchange's competitive position. Furthermore,
Discretionary Orders should enable participants to provide price
improvement beyond the price at which they are willing to submit an
order today, consistent with just and equitable principles of trade,
removing impediments to and perfecting the mechanism of a free and open
market and a national market system, and, in general, protecting
investors and the public interest.
---------------------------------------------------------------------------

    \3\ 15 U.S.C. 78f.
    \4\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

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

    BX does not believe that the proposed rule change will impose any
burden on competition not necessary or appropriate in furtherance of
the purposes of the Act.

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

    No written comments were either solicited or received.

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 after the date of the filing, or such
shorter time as the Commission may designate, it has become effective
pursuant to 19(b)(3)(A) of the Act \5\ and Rule 19b-4(f)(6) \6\
thereunder.
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78s(b)(3)(A).
    \6\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b4(f)(6)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change at
least five business days prior to the date of filing of the proposed
rule change, or such shorter time as designated by the Commission.
The Exchange has satisfied this requirement.
---------------------------------------------------------------------------

    The Exchange has requested that the Commission waive the 30-day
operative delay so that the proposed rule change may become effective
and operative upon filing with the Commission. The Commission believes
waiver of the 30-day operative delay is in the interest of investors
because it will expedite the introduction of new features to the BX
equities market. The features are currently available on other
exchanges, and the Commission sees no reason to delay their
introduction at the Exchange. Therefore, the Commission designates the
proposal to be operative upon filing.\7\
---------------------------------------------------------------------------

    \7\ For purposes only of waiving the 30-day operative delay, 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.

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-BX-2011-077 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-BX-2011-077. 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
a.m. and 3 p.m. Copies of such 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-BX-2011-077 and should be
submitted on or before December 13, 2011.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\8\
---------------------------------------------------------------------------

    \8\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2011-30057 Filed 11-21-11; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 83, Number 111 (Friday, June 8, 2018)]
[Notices]
[Pages 26731-26732]
[FR Doc No: 2018-12323]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-83372; File No. SR-ICEEU-2018-008]

Self-Regulatory Organizations; ICE Clear Europe Limited; Notice
of Filing and Immediate Effectiveness of a Proposed Rule Change
Relating to Amendments to the ICE Clear Europe Delivery Procedures

June 4, 2018.
    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 May 29, 2018, ICE Clear Europe Limited (``ICE Clear Europe'' or the
``Clearing House'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change described in Items I, II and
III below, which Items have been prepared by ICE Clear Europe. 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\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Clearing Agency's Statement of the Terms of Substance of the
Proposed Rule Change, Security-Based Swap Submission, or Advance Notice

    The principal purpose of the proposed amendments is for ICE Clear
Europe to amend its Delivery Procedures (the ``Delivery Procedures'')
\3\ with respect to the delivery terms relating to the ICE Futures
Europe (``IFEU'') Robusta Coffee Futures Contract.
---------------------------------------------------------------------------

    \3\ Capitalized terms used but not defined herein have the
meanings specified in the ICE Clear Europe Delivery Procedures.
---------------------------------------------------------------------------

II. Clearing Agency's Statement of the Purpose of, and Statutory Basis
for, the Proposed Rule Change, Security-Based Swap Submission or
Advance Notice

    In its filing with the Commission, ICE Clear Europe 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. ICE Clear Europe has prepared summaries,
set forth in sections (A), (B), and (C) below, of the most significant
aspects of such statements.

(A) Clearing Agency's Statement of the Purpose of, and Statutory Basis
for, the Proposed Rule Change, Security-Based Swap Submission or
Advance Notice

(a) Purpose
    ICE Clear Europe is amending its Delivery Procedures to make
certain modifications and clarifications to the delivery terms relating
to the IFEU Robusta Coffee Futures Contract. The amendments also remove
outdated references, correct typographical errors, insert references to
current ICE systems and align naming conventions used throughout the
Delivery Procedures.
    The changes are intended to be consistent with changes made to the
IFEU contract specifications for the Robusta Coffee Futures Contract.
In particular, the amendments to the Delivery Procedures will shorten
the delivery period from the delivery notice to the final settlement
day from 14 calendar days to 4 calendar days to reflect suggestions
from market participants that the current period was unnecessarily
long. A shorter period also more closely aligns with other similar
futures contracts, including the ICE Futures US Coffee Futures
Contract.
    As a result of this change, the amendments also remove the existing
``Early Take Up'' concept as this is no longer necessary given the
shorter settlement period.
    The changes also remove the Delivery Documentation Summary section,
because this simply repeats what is set out in the Delivery Procedures
above and is therefore, unnecessary.
(b) Statutory Basis
    Section 17A(b)(3)(F) of the Act \4\ requires, among other things,
that the rules of a clearing agency be designed to promote the prompt
and accurate clearance and settlement of securities transactions and,
to the extent applicable, derivative agreements, contracts, and
transactions, the safeguarding of securities and funds in the custody
or control of the clearing agency or for which it is responsible, and
the protection of investors and the public interest. The proposed
amendments shorten the delivery period for the Robusta Coffee Futures
Contracts, and make certain related

improvements to the delivery process, consistent with market feedback,
recent changes to relevant IFEU rules and other similar futures
contracts, such as the ICE Futures US Coffee Futures Contract. The
changes thus facilitate prompt and accurate clearance and settlement of
the Robusta Coffee Futures Contracts.
---------------------------------------------------------------------------

    \4\ 15 U.S.C. 78q-1(b)(3)(F).
---------------------------------------------------------------------------

    In addition, Rule 17Ad-22(e)(10) \5\ requires that each covered
clearing agency establish, implement, maintain and enforce written
policies and procedures reasonably designed to establish and maintain
written standards that state its obligations with respect to the
delivery of physical instruments. As discussed above, ICE Clear Europe
is updating its Delivery Procedures to reflect the shortened delivery
period, to remove the ``Early Take Up'' concept which is no longer
necessary in light of that shorter period, and to make certain other
clarifications and updates, consistent with the delivery terms set out
in the IFEU contract specifications.
---------------------------------------------------------------------------

    \5\ 17 CFR 240.17Ad-22(e)(10).
---------------------------------------------------------------------------

(B) Clearing Agency's Statement on Burden on Competition

    ICE Clear Europe does not believe the proposed rule changes would
have any impact, or impose any burden, on competition not necessary or
appropriate in furtherance of the purposes of the Act. The changes are
being proposed in order to update the Delivery Procedures for the IFEU
Robusta Coffee Futures Contract specifications, as discussed above. ICE
Clear Europe does not believe the amendments would adversely affect
Clearing Members, materially affect the cost of clearing, adversely
affect access to clearing in Robusta Coffee Futures Contract for
Clearing Members or their customers, or otherwise adversely affect
competition in clearing services. Accordingly, ICE Clear Europe does
not believe that the amendments would impose any impact or burden on
competition that is not appropriate in furtherance of the purpose of
the Act.

(C) Clearing Agency's Statement on Comments on the Proposed Rule Change
Received From Members, Participants or Others

    Written comments relating to the proposed amendments have not been
solicited or received by ICE Clear Europe. ICE Clear Europe will notify
the Commission of any comments received with respect to the proposed
amendments.

III. Date of Effectiveness of the Proposed Rule Change, Security-Based
Swap Submission and Advance Notice and Timing for Commission Action

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A) of the Act \6\ and paragraph (f) of Rule 19b-4 \7\
thereunder. 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.
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78s(b)(3)(A).
    \7\ 17 CFR 240.19b-4(f).
---------------------------------------------------------------------------

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change, security-based swap submission or advance notice 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 protected]. Please include
File Number SR-ICEEU-2018-008 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-ICEEU-2018-008. 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 website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change, security-based
swap submission or advance notice that are filed with the Commission,
and all written communications relating to the proposed rule change,
security-based swap submission or advance notice 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 website 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
ICE Clear Europe and on ICE Clear Europe's website at https://www.theice.com/publicdocs/regulatory_filings/19b-4_2018_008_ICEU.pdf.
All comments received will be posted without change. Persons submitting
comments are cautioned that we do not redact or edit personal
identifying information from comment submissions. You should submit
only information that you wish to make available publicly. All
submissions should refer to File Number SR-ICEEU-2018-008 and should be
submitted on or before June 29, 2018.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\8\
---------------------------------------------------------------------------

    \8\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2018-12323 Filed 6-7-18; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 77, Number 154 (Thursday, August 9, 2012)]
[Rules and Regulations]
[Pages 47539-47544]
[FR Doc No: 2012-19320]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2010-0637; FRL-9357-1]

Paraquat Dichloride; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes tolerances for residues of
paraquat dichloride (hereafter in this document referred to solely as
paraquat) in or on multiple commodities which are identified and
discussed later in this document. Interregional Research Project Number
4 (IR-4) requested these tolerances under the Federal Food, Drug, and
Cosmetic Act (FFDCA).

DATES: This regulation is effective August 9, 2012. Objections and
requests for hearings must be received on or before October 9, 2012,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2010-0637, is available at http://www.regulations.gov or at the OPP Docket in the Environmental
Protection Agency Docket Center (EPA/DC), located in EPA West, Rm.
3334, 1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Andrew Ertman, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to those
engaged in the following activities:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather to
provide a guide for readers regarding entities likely to be affected by
this action. Other types of entities not listed in this unit could also
be affected. The North American Industrial Classification System
(NAICS) codes have been provided to assist you and others in
determining whether this action might apply to certain entities. If you
have any questions regarding the applicability of this action to a
particular entity, consult the person listed under FOR FURTHER
INFORMATION CONTACT.

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2010-0637 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
October 9, 2012. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket. Information not marked confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA without prior notice. Submit a copy of
your non-CBI objection or hearing request, identified by docket ID
number EPA-HQ-OPP-2010-0637, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), Mail Code: 28221T, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.htm.

    Additional instructions on commenting or visiting the docket,

along with more information about dockets generally, is available at
http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of October 27, 2010 (75 FR 66092) (FRL-
9218-2), EPA issued a notice pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
0E7748) by IR-4 Project Headquarters, Rutgers, the State University of
New Jersey, 500 College Road East, Suite 201 W, Princeton, NJ 08540.
The petition requested that 40 CFR 180.205 be amended by establishing
tolerances for residues of the dessicant, defoliant, and herbicide
paraquat dichloride, (1,1'-dimethyl-4,4'-bipyridinium-ion) derived from
application of either the bis(methyl sulfate) or the dichloride salt
(both calculated as the cation), in or on the following perennial
tropical and subtropical fruit trees: Sugar apple, cherimoya, atemoya,
custard apple, ilama, soursop, biriba, lychee, longan, Spanish lime,
rambutan, pulasan, star apple, black sapote, mango, sapodilla,
canistel, mamey sapote, feijoa, jaboticaba, wax jambu, starfruit
(carambola), pawpaw, pomegranate, and white sapote at 0.05 parts per
million (ppm). That notice referenced a summary of the petition
prepared by Syngenta, the registrant, which is available in the docket,
http://www.regulations.gov. There were no comments received in response
to the notice of filing.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. * *
*''
    Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for paraquat including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with paraquat follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children.
    Paraquat is severely toxic following acute exposure via the dermal
and inhalation routes and only slightly less toxic by the oral route of
exposure. It is a dermal and ocular irritant but is not a skin
sensitizer.
    The primary target organ of paraquat is the lung. Evidence of lung
inflammation, scarring, and compromised lung function in response to
paraquat are observed throughout the toxicity database in different
species (rats, mice, and dogs). Effects in the respiratory tract are
observed after acute, subchronic, and chronic exposures regardless of
the route of exposure (oral or inhalation). However, inhalation was a
more sensitive route of exposure than the oral route. With increasing
durations of exposure, effects of paraquat in other organ systems are
observed. These effects include liver inflammation and necrosis in rats
and inflammation and necrosis of the kidneys in rats and mice.
Lenticular changes in the eyes of rats were also observed with
increasing durations of exposure. Importantly, the lung effects occur
at doses lower than effects in these other organs systems, and so
protecting for lung effects protects for all other adverse effects of
paraquat.
    The effects of paraquat in lungs are considered systemic effects.
There are no dermal toxicity studies suitable for evaluation of
systemic lung effects in the toxicity database for paraquat. Therefore,
the Agency is using a dermal absorption factor of 0.3%, which was
derived from dermal absorption studies conducted in humans and monkeys
and an oral endpoint for dermal risk assessments.
    Paraquat does not cause reproductive toxicity. Developmental
toxicity in response to paraquat, when observed, always occurred in the
presence of maternal toxicity. Four developmental toxicity studies (two
in rats and two in mice) are available. Since effects in the offspring
(e.g., reduced body weight/gain and delayed skeletal ossification),
when present, were lesser in severity than those observed in maternal
animals (e.g., respiratory distress, reduced body weight, lesions in
the lungs and kidneys) and were also consistent with those commonly
observed as secondary to maternal toxicity, the Agency has concluded
that there was no evidence of qualitative susceptibility in the young.
    Previously, the Agency had required that a developmental toxicity
study in rabbits be conducted for paraquat. As a result, the Food
Quality Protection Act (FQPA) Safety Factor (SF) had been retained as a
3X database uncertainty factor for Females 13-39 years old for the
acute dietary risk assessment only. The Agency recently reviewed the
toxicity database for paraquat and concluded that a developmental
toxicity study in rabbits was not likely to add information that would
impact the paraquat risk assessment. Therefore, this study is no longer
required and the FQPA Safety Factor has been reduced to 1X for this
population.
    No evidence of neurotoxicity was observed in acute and subchronic
neurotoxicity studies conducted with paraquat up to the doses at which
respiratory effects were observed (e.g. the maximum tolerated dose).
There was also no evidence of immunotoxicity in response to paraquat.
    Based on the lack of evidence of carcinogenicity in mice and rats,
the Agency has concluded that there is no concern for the carcinogenic
potential of paraquat. Paraquat was not mutagenic in the Salmonella
typhimurium assay, was not genotoxic in the unscheduled DNA synthesis
assay in vitro or in vivo, was negative for chromosomal aberration in
the bone marrow test, and no evidence was found for suppressed
fertility or dominant lethal mutagenicity in mice. Conversely, paraquat
was found to be weakly positive in the mouse lymphoma assay and human
lymphocyte cytogenetic assay, and was positive in the sister chromatid
exchange assay.
    Specific information on the studies received and the nature of the
adverse effects caused by paraquat as well as the no-observed-adverse-
effect-level (NOAEL) and the lowest-observed-adverse-effect-level
(LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document ``Paraquat Dichloride. Human Health

Risk Assessment for the Request to Add Uses on Perennial Tropical and
Sub-Tropical Fruit Trees'' on pps. 31-35 in docket ID number EPA-HQ-
OPP-2010-0637.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern (LOC) to use in evaluating the risk posed by human exposure to
the pesticide. For hazards that have a threshold below which there is
no appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for paraquat used for
human risk assessment is shown in the following table.

    Table--Summary of Toxicological Doses and Endpoints for Paraquat for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                    Point of departure    RfD, PAD, LOC for
        Exposure/Scenario            and uncertainty/      risk assessment      Study and toxicological effects
                                      safety factors        (in mg/kg/day)
----------------------------------------------------------------------------------------------------------------
Acute dietary (all populations)..  NOAEL = 1.25 mg/kg/   aRfD = 0.0125......  Multi-generation rat study.
                                    day.                 aPAD = .0125.......  LOAEL = 3.75 mg/kg/day, based on
                                   UFA = 10xUFH =                              increased incidences of alveolar
                                    10xFQPA.                                   histiocytes in both sexes.
                                   SF = 1x.............
Chronic dietary (All populations)  NOAEL = 0.45 mg/kg/   cRfD = 0.0045......  Chronic toxicity in dogs.
                                    day.                 cPAD = .0045.......  LOAEL = 0.93 mg/kg/day, based on
                                   UFA = 10x...........                        increased severity of chronic
                                   UFH = 10x...........                        pneumonitis and gross lung
                                   FQPA SF = 1x........                        lesions in both sexes, and focal
                                                                               pulmonary granulomas in males.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
  level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
  UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
  members of the human population (intraspecies).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to paraquat, EPA considered exposure under the petitioned-for
tolerances as well as all existing paraquat tolerances in 40 CFR
180.205. EPA assessed dietary exposures from paraquat in food as
follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure.
    Such effects were identified for paraquat. In estimating acute
dietary exposure, EPA used food consumption information from the United
States Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide
Continuing Surveys of Food Intake by Individuals (CSFII). As to residue
levels in food, the acute analysis assumed a distribution of residues
based on tolerance level residues. Empirical and Dietary Exposure
Evaluation Model (DEEM) default processing factors were used to modify
the field trial data. Maximum screening-level percent crop treated
(PCT) estimates were used for commodities for which data were
available. If no PCT data were available, 100 PCT was assumed.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 1994-1996
and 1998 CSFII. As to residue levels in food, EPA assumed tolerance
level residues and average estimates of PCT.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that paraquat does not pose a cancer risk to humans.
Therefore, a dietary exposure assessment for the purpose of assessing
cancer risk is unnecessary.
    iv. Anticipated residue and PCT information. Section 408(b)(2)(F)
of FFDCA states that the Agency may use data on the actual percent of
food treated for assessing chronic dietary risk only if:
     Condition a: The data used are reliable and provide a
valid basis to show what percentage of the food derived from such crop
is likely to contain the pesticide residue.
     Condition b: The exposure estimate does not underestimate
exposure for any significant subpopulation group.
     Condition c: Data are available on pesticide use and food
consumption in a particular area, the exposure estimate does not
understate exposure for the population in such area. In addition, the
Agency must provide for periodic evaluation of any estimates used. To
provide for the periodic evaluation of the estimate of PCT as required
by FFDCA section 408(b)(2)(F), EPA may require registrants to submit
data on PCT.
    The Agency estimated the PCT in the chronic dietary risk assessment
for existing uses as follows: Alfalfa, 1%; almonds, 25%; apples, 20%;
apricots, 10%; artichokes, 25%; asparagus, 10%; avocados, 2.5%; barley,
1%; green beans, 1%; blackberries, 30%; blueberries, 10%; broccoli, 1%;
cabbage, 2.5%; caneberries, 45%; cantaloupes, 5%; carrots, 2.5%;
celery, 1%; cherries, 20%; corn, 2.5%; cotton, 15%; cucumbers, 5%; dry
beans/peas, 2.5%; summer fallow, 1%; garlic, 1%; grapefruit, 2.5%;
grapes, 20%; kiwifruit, 30%; lemons, 2.5%; lettuce, 1%;

nectarines, 10%; olives, 5%; onions, 5%; oranges, 5%; pasture, 1%;
pastureland, 1%; peaches, 30%; peanuts, 20%; pears, 10%; green peas,
1%; pecans, 5%; peppers, 10%; pistachios, 25%; plums, 15%; potatoes,
5%; prunes, 10%; pumpkins, 5%; raspberries, 70%; rice, 1%; sorghum, 1%;
soybeans, 1%; spinach, 5%; squash, 5%; strawberries, 10%; sugar beets,
1%; sugarcane, 5%; sunflowers, 1%; sweet corn, 2.5%; tangelos, 10%;
tangerines, 10%; tobacco, 1%; tomatoes, 5%; walnuts, 15%; watermelons,
5%; wheat, 1%.
    In most cases, EPA uses available data from USDA/National
Agricultural Statistics Service (NASS), proprietary market surveys, and
the National Pesticide Use Database for the chemical/crop combination
for the most recent 6-7 years. EPA uses an average PCT for chronic
dietary risk analysis. The average PCT figure for each existing use is
derived by combining available public and private market survey data
for that use, averaging across all observations, and rounding to the
nearest 5%, except for those situations in which the average PCT is
less than one. In those cases, 1% is used as the average PCT and 2.5%
is used as the maximum PCT. EPA uses a maximum PCT for acute dietary
risk analysis. The maximum PCT figure is the highest observed maximum
value reported within the recent 6 years of available public and
private market survey data for the existing use and rounded up to the
nearest multiple of 5%.
    The Agency believes that the three conditions discussed in Unit
III.C.1.iv. have been met. With respect to Condition a, PCT estimates
are derived from Federal and private market survey data, which are
reliable and have a valid basis. The Agency is reasonably certain that
the percentage of the food treated is not likely to be an
underestimation. As to Conditions b and c, regional consumption
information and consumption information for significant subpopulations
is taken into account through EPA's computer-based model for evaluating
the exposure of significant subpopulations including several regional
groups. Use of this consumption information in EPA's risk assessment
process ensures that EPA's exposure estimate does not understate
exposure for any significant subpopulation group and allows the Agency
to be reasonably certain that no regional population is exposed to
residue levels higher than those estimated by the Agency. Other than
the data available through national food consumption surveys, EPA does
not have available reliable information on the regional consumption of
food to which may be applied in a particular area.
    2. Dietary exposure from drinking water. In the past the EPA has
concluded that though paraquat undergoes minimal degradation in the
environment, and thus is very persistent (as parent), paraquat residues
are not expected in surface or ground water. Paraquat has a very high
propensity to bind to solids, particularly clay, which makes it very
immobile. In addition, paraquat does not readily appear to desorb from
clay. The greatest cause for concern is likely to be erosion of
contaminated sediments off-site and subsequent redeposition onto non-
target areas (especially surface water bodies). Because of its very low
mobility and strong tendency to bind tightly to soils, paraquat
contamination of drinking water supplies derived from groundwater is
expected to be highly unlikely. In addition, the strong binding
characteristics of paraquat dichloride are likely to render most
residues in raw drinking water sources removable through sedimentation
processes, which are typically included as part of standard drinking
water treatments.
    Because of its strong cation-exchange sorption to soils, modeling
is not appropriate for paraquat. In most circumstances, the levels of
paraquat residues in surface or ground water are expected to be
insignificant. Because it should sorb to suspended sediment,
coagulation and flocculation processes in drinking water treatment
plants are likely to remove any paraquat dichloride residues present in
the raw water. Residues of paraquat dichloride in drinking water
derived from surface supplies can therefore be assumed to be
negligible.
    In order to determine the most appropriate and realistic drinking
water numbers to use in the human health risk assessment, the Agency
reviewed a non-guideline supplemental mobility study that was conducted
to evaluate the effects of traditional water treatment processes on
paraquat and to determine the mobility of paraquat through soil
filtration column. \14\C-paraquat, spiked at ~30 parts per billion
(ppb) into the raw surface water samples from five representative U.S.
community water supply facilities, was effectively removed by a
combination of typical water treatment processes conducted on a
laboratory-scale: The ``laboratory jar test'' (coagulation using alum
with either lime or soda ash, flocculation and sedimentation), followed
by duel media filtration (anthracite atop of filtering sand). The
combination process was able to reduce the level of \14\C-paraquat to
approximate or below the limit of detection of approximately 0.15
microgram/per liter ([mu]g/L) ppb. The level of paraquat in the
finished water of 0.15 ppb was used in both the acute and chronic
assessments.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
    Paraquat is not registered for any specific use patterns that would
result in residential exposure.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of 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 found paraquat to share a common mechanism of toxicity
with any other substances, and paraquat does not appear to produce a
toxic metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed that paraquat 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 EPA's Web site at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA SF. In
applying this provision, EPA either retains the default value of 10X,
or uses a different additional safety factor when reliable data
available to EPA support the choice of a different factor.
    2. Prenatal and postnatal sensitivity. Prenatal developmental
studies in rats and mice show that developmental effects only occur in
the presence of maternal toxicity. No effect on

reproduction was observed. Fetal effects were limited to delayed
ossification and decreased body weights. There was no indication from
these studies that paraquat dichloride is involved in endocrine
disruption.
    3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X. That decision is based on the following
findings:
    i. The toxicity database for paraquat is complete.
    ii. There is no indication that paraquat is a neurotoxic chemical
and there is no need for a developmental neurotoxicity study or
additional UFs to account for neurotoxicity.
    iii. There is no evidence that paraquat results in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study.
    iv. There are no residual uncertainties identified in the exposure
databases. The acute dietary exposure analysis is based on tolerance
level residues and maximum estimates of PCT. The chronic analysis is
based on tolerance level residues and average estimates of percent crop
treated. For estimating levels of paraquat in drinking water, the
Agency relied on a study that evaluated the effects of traditional
water treatment processes on paraquat. These assessments will not
underestimate the exposure and risks posed by paraquat.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
    1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to paraquat will occupy 21% of the aPAD for children 1-2 years old, the
population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
paraquat from food and water will utilize 14% of the cPAD for children
1-2 years old, the population group receiving the greatest exposure.
There are no residential uses for paraquat.
    3. Short- and Intermediate-term risk. Short- and intermediate-term
aggregate exposure takes into account short- and intermediate-term
residential exposure plus chronic exposure to food and water
(considered to be a background exposure level). A short- and
intermediate-term adverse effect was identified; however, paraquat is
not registered for any use patterns that would result in short- and/or
intermediate-term residential exposure. Short- and intermediate-term
risk is assessed based on short- and intermediate-term residential
exposure plus chronic dietary exposure. Because there is no short- and
intermediate-term residential exposure and chronic dietary exposure has
already been assessed under the appropriately protective cPAD (which is
at least as protective as the POD used to assess short- and
intermediate-term risk), no further assessment of short- and
intermediate-term risk is necessary, and EPA relies on the chronic
dietary risk assessment for evaluating short- and intermediate-term
risk for paraquat.
    4. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, paraquat is not expected to pose a cancer risk to humans.
    5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population or to infants and children from aggregate
exposure to paraquat residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    An adequate spectrophotometric method, Method I of the Pesticide
Analytical Manual (PAM) Vol. II, is available for enforcing tolerances
for residues of paraquat in/on plant commodities.
    The methods may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
    The Codex has established MRLs for paraquat in or on assorted
tropical and subtropical fruits-inedible peel (includes all except
atemoya, biriba, jaboticaba, starfruit, and wax jambu) at 0.01 ppm.
These MRLs are different from the tolerances being established for
paraquat in the United States. The Agency cannot harmonize with the
Codex MRL because there were residues greater than 0.01 ppm in some of
the data on which the proposed U.S tolerances are based.

V. Conclusion

    Therefore, tolerances are established for residues of paraquat
dichloride, (1,1'-dimethyl-4,4'-bipyridinium-ion) derived from
application of either the bis(methylsulfate) or the dichloride salt
(both calculated as the cation), in or on the following: Sugar apple,
cherimoya, atemoya, custard apple, ilama, soursop, biriba, lychee,
longan, Spanish lime, rambutan, pulasan, star apple, black sapote,
mango, sapodilla, canistel, mamey sapote, feijoa, jaboticaba, wax
jambu, starfruit (carambola), pawpaw, pomegranate, and white sapote at
0.05 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under FFDCA section 408(d)
in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this final rule has
been exempted from review under Executive Order 12866, this final rule
is not subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885,

April 23, 1997). This final rule does not contain any information
collections subject to OMB approval under the Paperwork Reduction Act
(PRA), 44 U.S.C. 3501 et seq., nor does it require any special
considerations under Executive Order 12898, entitled ``Federal Actions
To Address Environmental Justice in Minority Populations and Low-Income
Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
    This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Pub. L. 104-4).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: July 27, 2012.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. Section 180.205 is amended by alphabetically adding the following
new entries to the table in paragraph (a) to read as follows:

Sec.  180.205  Paraquat; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------

                                * * * * *
Atemoya.....................................................        0.05

                                * * * * *
Biriba......................................................        0.05

                                * * * * *
Canistel....................................................        0.05

                                * * * * *
Cherimoya...................................................        0.05

                                * * * * *
Custard apple...............................................        0.05

                                * * * * *
Feijoa......................................................        0.05

                                * * * * *
Ilama.......................................................        0.05
Jaboticaba..................................................        0.05

                                * * * * *
Longan......................................................        0.05
Lychee......................................................        0.05
Mango.......................................................        0.05

                                * * * * *
Pawpaw......................................................        0.05

                                * * * * *
Pomegranate.................................................        0.05

                                * * * * *
Pulasan.....................................................        0.05
Rambutan....................................................        0.05

                                * * * * *
Sapodilla...................................................        0.05
Sapote, black...............................................        0.05
Sapote, mamey...............................................        0.05
Sapote, white...............................................        0.05

                                * * * * *
Soursop.....................................................        0.05

                                * * * * *
Spanish lime................................................        0.05

                                * * * * *
Star apple..................................................        0.05
Starfruit...................................................        0.05

                                * * * * *
Sugar apple.................................................        0.05

                                * * * * *
Wax jambu...................................................        0.05
------------------------------------------------------------------------

* * * * *
[FR Doc. 2012-19320 Filed 8-8-12; 8:45 am]
BILLING CODE 6560-50-P