[Federal Register Volume 77, Number 69 (Tuesday, April 10, 2012)]
[Rules and Regulations]
[Pages 21471-21476]
[FR Doc No: 2012-8568]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

44 CFR Part 67

[Docket ID FEMA-2012-0003]

Final Flood Elevation Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Final rule.

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

SUMMARY: Base (1% annual-chance) Flood Elevations (BFEs) and modified
BFEs are made final for the communities listed below. The BFEs and
modified BFEs are the basis for the floodplain management measures that
each community is required either to adopt or to show evidence of being
already in effect in order to qualify or remain qualified for
participation in the National Flood Insurance Program (NFIP).

DATES: Effective dates: The date of issuance of the Flood Insurance
Rate Map (FIRM) showing BFEs and modified BFEs for each community. This
date may be obtained by contacting the office where the maps are
available for inspection as indicated in the table below.

ADDRESSES: The final BFEs for each community are available for
inspection at the office of the Chief Executive Officer of each
community. The respective addresses are listed in the table below.

FOR FURTHER INFORMATION CONTACT: Luis Rodriguez, Chief, Engineering
Management Branch, Federal Insurance and Mitigation Administration,
Federal Emergency Management Agency, 500 C Street SW., Washington, DC
20472,

(202) 646-4064, or (email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Federal Emergency Management Agency
(FEMA) makes the final determinations listed below for the modified
BFEs for each community listed. These modified elevations have been
published in newspapers of local circulation and ninety (90) days have
elapsed since that publication. The Deputy Associate Administrator for
Mitigation has resolved any appeals resulting from this notification.
    This final rule is issued in accordance with section 110 of the
Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR part
67. FEMA has developed criteria for floodplain management in floodprone
areas in accordance with 44 CFR part 60.
    Interested lessees and owners of real property are encouraged to
review the proof Flood Insurance Study and FIRM available at the
address cited below for each community. The BFEs and modified BFEs are
made final in the communities listed below. Elevations at selected
locations in each community are shown.
    National Environmental Policy Act. This final rule is categorically
excluded from the requirements of 44 CFR part 10, Environmental
Consideration. An environmental impact assessment has not been
prepared.
    Regulatory Flexibility Act. As flood elevation determinations are
not within the scope of the Regulatory Flexibility Act, 5 U.S.C. 601-
612, a regulatory flexibility analysis is not required.
    Regulatory Classification. This final rule is not a significant
regulatory action under the criteria of section 3(f) of Executive Order
12866 of September 30, 1993, Regulatory Planning and Review, 58 FR
51735.
    Executive Order 13132, Federalism. This final rule involves no
policies that have federalism implications under Executive Order 13132.
    Executive Order 12988, Civil Justice Reform. This final rule meets
the applicable standards of Executive Order 12988.

List of Subjects in 44 CFR Part 67

    Administrative practice and procedure, Flood insurance, Reporting
and recordkeeping requirements.
    Accordingly, 44 CFR part 67 is amended as follows:

PART 67--[AMENDED]

0
1. The authority citation for part 67 continues to read as follows:

    Authority:  42 U.S.C. 4001 et seq.; Reorganization Plan No. 3 of
1978, 3 CFR, 1978 Comp., p. 329; E.O. 12127, 44 FR 19367, 3 CFR,
1979 Comp., p. 376.

Sec.  67.11  [Amended]

0
2. The tables published under the authority of Sec.  67.11 are amended
as follows:

----------------------------------------------------------------------------------------------------------------
                                                                        * Elevation in
                                                                        feet (NGVD) +
                                                                      Elevation in feet
                                                                       (NAVD)
          Flooding source(s)               Location of referenced       Depth in feet      Communities affected
                                                 elevation               above ground
                                                                      [caret] Elevation
                                                                       in meters (MSL)
                                                                           Modified
----------------------------------------------------------------------------------------------------------------
                                 Gilmer County, Georgia, and Incorporated Areas
                                             Docket No.: FEMA-B-1155
----------------------------------------------------------------------------------------------------------------
Cartecay River.......................  Approximately 1.12 miles                   +1290  Unincorporated Areas of
                                        upstream of Holt Bridge Road.                     Gilmer County.
                                       Approximately 0.24 mile                    +1519
                                        upstream of the Owltown
                                        Creek confluence.
----------------------------------------------------------------------------------------------------------------
* National Geodetic Vertical Datum.
+ North American Vertical Datum.
 Depth in feet above ground.
[caret] Mean Sea Level, rounded to the nearest 0.1 meter.

                                                    ADDRESSES

                                      Unincorporated Areas of Gilmer County
Maps are available for inspection at the Gilmer County Courthouse, 1 Broad Street, Ellijay, GA 30540.
----------------------------------------------------------------------------------------------------------------
                                Chisago County, Minnesota, and Incorporated Areas
                                             Docket No.: FEMA-B-1134
----------------------------------------------------------------------------------------------------------------
Lake Ellen...........................  Entire shoreline.............               +895  City of Chisago City.
Skogman Lake.........................  Entire shoreline within                     +950  Unincorporated Areas of
                                        Chisago County.                                   Chisago County.
----------------------------------------------------------------------------------------------------------------
* National Geodetic Vertical Datum.
+ North American Vertical Datum.
 Depth in feet above ground.
[caret] Mean Sea Level, rounded to the nearest 0.1 meter.

                                                    ADDRESSES

City of Chisago City
Maps are available for inspection at City Hall, 10625 Railroad Avenue, Chisago City, MN 55013.

                                     Unincorporated Areas of Chisago County
Maps are available for inspection at the Chisago County Government Center, 313 North Main Street, Center City,
 MN 55012.
----------------------------------------------------------------------------------------------------------------

                                 Clay County, Minnesota, and Incorporated Areas
                                             Docket No.: FEMA-B-1078
----------------------------------------------------------------------------------------------------------------
Buffalo River........................  At the confluence with the                  +883  City of Georgetown,
                                        Red River of the North.                           Unincorporated Areas
                                                                                of Clay County.
                                       Just downstream of U.S. Route               +948
                                        10 (1st crossing).
Oakport Coulee.......................  At the convergence with the                 +893  Unincorporated Areas of
                                        Red River of the North.                           Clay County.
                                       Approximately 2,500 feet                    +896
                                        downstream of Wall Street
                                        Avenue North/County Highway
                                        22.
County Ditch No. 20 (Lower Reach)....  At the convergence with the                 +888  Unincorporated Areas of
                                        Red River of the North.                           Clay County.
                                       At the divergence from County               +893
                                        Ditch No. 20 (Connecting
                                        Reach/Upper Reach).
County Ditch No. 41..................  Approximately 5,645 feet                    +908  City of Moorhead,
                                        downstream of Main Street                         Unincorporated Areas
                                        South/County Highway 78.                          of Clay County.
                                       At the divergence of County                 +910
                                        Ditch No. 41 Lateral No. 1.
County Ditch No. 41 Lateral No. 1....  At 34th Street North.........               +906  City of Dilworth,
                                                                                Unincorporated Areas
                                                                                of Clay County.
                                       At the divergence of County                 +910
                                        Ditch No. 41.
County Ditch No. 50..................  At 34th Street North.........               +905  City of Dilworth.
                                       Approximately 1,700 feet                    +910
                                        upstream of U.S. Route 10/
                                        Center Avenue East.
County Drain No. 51..................  At the confluence with the                  +891  Unincorporated Areas of
                                        Buffalo River.                                    Clay County.
                                       Approximately 3,900 feet                    +902
                                        upstream of 90th Avenue
                                        North/County Highway 26.
Glyndon Tributary....................  Approximately 1,700 feet                    +916  City of Glyndon,
                                        downstream of U.S. Route 10/                      Unincorporated Areas
                                        State Street.                                     of Clay County.
                                       At 110th Street South/County                +926
                                        Highway 71.
Red River of the North...............  At the Norman County boundary               +879  City of Georgetown,
                                                                                City of Moorhead,
                                                                                Unincorporated Areas
                                                                                of Clay County.
                                       At the Wilkin County boundary               +919
South Branch Buffalo River...........  At the confluence with the                  +915  Unincorporated Areas of
                                        Buffalo River.                                    Clay County.
                                       Approximately 200 feet                      +942
                                        downstream of 180th Avenue
                                        South.
South Branch Wild Rice River.........  Backwater area approximately               +1119  City of Ulen.
                                        1,450 feet downstream of
                                        Burlington Northern & Santa
                                        Fe Railway/State Highway 32.
Stony Creek..........................  At the confluence with South                +924  Unincorporated Areas of
                                        Branch Buffalo River.                             Clay County.
                                       Approximately 100 feet                      +924
                                        upstream of the confluence
                                        with South Branch Buffalo
                                        River.
Unnamed Tributary to Whisky Creek....  At 165th Avenue South........               +993  Unincorporated Areas of
                                                                                Clay County.
                                       Approximately 3,110 feet                   +1030
                                        upstream of Front Street
                                        South/County Highway 52.
----------------------------------------------------------------------------------------------------------------
* National Geodetic Vertical Datum.
+ North American Vertical Datum.
 Depth in feet above ground.
[caret] Mean Sea Level, rounded to the nearest 0.1 meter.

                                                    ADDRESSES

City of Dilworth
Maps are available for inspection at 21st Avenue Southeast, Dilworth, MN 56529.

City of Georgetown
Maps are available for inspection at 127 Main Street, Georgetown, MN 56546.

City of Glyndon
Maps are available for inspection at 36 3rd Street Southeast, Glyndon, MN 56547.

City of Moorhead
Maps are available for inspection at 500 Center Avenue, Moorhead, MN 56561.

City of Ulen
Maps are available for inspection at 201 1st Street Northwest, Ulen, MN 56585.

                                       Unincorporated Areas of Clay County
Maps are available for inspection at 807 11th Street North, Moorhead, MN 56560.
----------------------------------------------------------------------------------------------------------------
                                   Tioga County, New York (All Jurisdictions)
                                             Docket No.: FEMA-B-1089
----------------------------------------------------------------------------------------------------------------
Apalachin Creek......................  At the confluence with the                  +826  Town of Owego.
                                        Susquehanna River.
                                       Approximately 1,729 feet                    +826
                                        upstream of Main Street.
Owego Creek..........................  At the confluence with the                  +813  Town of Tioga, Village
                                        Susquehanna River.                                of Owego.
                                       Approximately 3,529 feet                    +813
                                        upstream of Waverly Road/
                                        West Main Street.
Susquehanna River....................  Approximately 2.3 miles                     +781  Town of Barton, Town of
                                        upstream of State Route 17.                       Nichols, Town of
                                                                                Owego, Town of Tioga,
                                                                                Village of Nichols,
                                                                                Village of Owego.
                                       Approximately 2.4 miles                     +829
                                        upstream of Valley View
                                        Drive.
West Branch Owego Creek..............  Approximately 2.86 miles                   +1028  Town of Berkshire.
                                        upstream of West Newark
                                        Cross Road.
                                       Approximately 2.95 miles                   +1029
                                        upstream of West Newark
                                        Cross Road.
----------------------------------------------------------------------------------------------------------------
* National Geodetic Vertical Datum.
+ North American Vertical Datum.
 Depth in feet above ground.
[caret] Mean Sea Level, rounded to the nearest 0.1 meter.

                                                    ADDRESSES

Town of Barton
Maps are available for inspection at the Barton Town Hall, 304 State Route 17C, Waverly, NY 14892.

Town of Berkshire
Maps are available for inspection at the Town Hall, 18 Railroad Avenue, Berkshire, NY 13736.

Town of Nichols
Maps are available for inspection at the Nichols Town Hall, 54 East River Road, Nichols, NY 13812.

Town of Owego
Maps are available for inspection at the Owego Town Hall, 2354 State Route 434, Apalachin, NY 13812.

Town of Tioga
Maps are available for inspection at the Tioga Town Hall, 54 5th Avenue, Tioga Center, NY 13845.

Village of Nichols
Maps are available for inspection at the Nichols Town Hall, 54 East River Road, Nichols, NY 13812.

Village of Owego
Maps are available for inspection at the Owego Village Municipal Building, Old Jail, 178 Main Street, Owego, NY
 13827.
----------------------------------------------------------------------------------------------------------------
                                Wagoner County, Oklahoma, and Incorporated Areas
                                    Docket Nos.: FEMA-B-1022 and FEMA-B-1112
----------------------------------------------------------------------------------------------------------------
Adams Creek..........................  Approximately 717 feet                      +600  Town of Fair Oaks.
                                        downstream of the confluence
                                        with School Creek.
                                       Approximately 0.61 mile                     +605
                                        upstream of the confluence
                                        with School Creek.
Arkansas River.......................  Approximately 6,809 feet from               +516  Unincorporated Areas of
                                        U.S. Route 69 upstream to                         Wagoner County.
                                        the limit of detailed study.
                                       Approximately 15,526 feet                   +523
                                        from U.S. Route 69
                                        downstream to the limit of
                                        detailed study.
Arkansas River (Corp of Engineers)...  Approximately 10,354 feet                   +551  Unincorporated Areas of
                                        from State Highway 104                            Wagoner County.
                                        downstream to the limit of
                                        detailed study.
                                       Limit of detailed study at                  +582
                                        Tulsa County boundary.
East Coal Creek......................  Approximately 386 feet                      +561  City of Wagoner.
                                        upstream from River Park
                                        Avenue.
                                       Approximately 213 feet                      +570
                                        upstream of Railroad Culvert.
Salt Creek...........................  Approximately 0.60 mile                     +557  Town of Fair Oaks.
                                        downstream of 305th Avenue.

                                       Approximately 365 feet                      +607
                                        upstream of 257th Avenue.
Verdigris River......................  Approximately 245 feet                      +516  Town of Okay.
                                        downstream of 72nd Street.
                                       Approximately 0.45 mile                     +516
                                        upstream of 72nd Street.
----------------------------------------------------------------------------------------------------------------
* National Geodetic Vertical Datum.
+ North American Vertical Datum.
 Depth in feet above ground.
[caret] Mean Sea Level, rounded to the nearest 0.1 meter.

                                                    ADDRESSES

Town of Fair Oaks
Maps are available for inspection at the Rogers County Commissioners Office, 219 South Missouri Street,
 Claremore, OK 74017.

Town of Okay
Maps are available for inspection at the Wagoner County Commissioners Office, 306 East Cherokee Street, Wagoner,
 OK 74107.

City of Wagoner
Maps are available for inspection at the Wagoner County Commissioners Office, 306 East Cherokee Street, Wagoner,
 OK 74107.

                                     Unincorporated Areas of Wagoner County
Maps are available for inspection at the Wagoner County Commissioners Office, 306 East Cherokee Street, Wagoner,
 OK 74107.
----------------------------------------------------------------------------------------------------------------
                              Lawrence County, South Dakota, and Incorporated Areas
                                             Docket No.: FEMA-B-1069
----------------------------------------------------------------------------------------------------------------
Hungry Hollow Gulch..................  Approximately 350 feet                     +3632  City of Spearfish.
                                        downstream of Ames Avenue.
                                       Approximately 645 feet                     +3699
                                        upstream of Saint Joe Street.
Ice House Creek......................  Approximately 25 feet                      +3658  City of Spearfish.
                                        upstream of Grant Street.
                                       Approximately 50 feet                      +3686
                                        upstream of State Street.
Ice House Creek Tributary A..........  Approximately 73 feet                      +3663  City of Spearfish.
                                        downstream of 8th Street.
                                       Approximately 150 feet                     +3671
                                        downstream of State Street.
Riggs Gulch..........................  Approximately 200 feet                     +3764  City of Spearfish.
                                        downstream of U.S. Route 14A.
                                       Approximately 920 feet                     +3843
                                        upstream of Colorado
                                        Boulevard.
Spearfish Creek......................  Just downstream of Utah                    +3570  City of Spearfish,
                                        Boulevard.                                        Unincorporated Areas
                                                                                of Lawrence County.
                                       Approximately 1,300 feet                   +3726
                                        upstream of Winterville
                                        Drive.
Unnamed Tributary to Higgins Gulch...  Approximately 4,430 feet                   +3440  City of Spearfish.
                                        downstream of the I-90 West
                                        ramp.
                                       Approximately 1,500 feet                   +3491
                                        downstream of the I-90 West
                                        ramp.
----------------------------------------------------------------------------------------------------------------
* National Geodetic Vertical Datum.
+ North American Vertical Datum.
 Depth in feet above ground.
[caret] Mean Sea Level, rounded to the nearest 0.1 meter.

                                                    ADDRESSES

City of Spearfish
Maps are available for inspection at 625 5th Street, Spearfish, SD 57783.

                                     Unincorporated Areas of Lawrence County
Maps are available for inspection at 90 Sherman Street, Deadwood, SD 57732.
----------------------------------------------------------------------------------------------------------------
                                Sumner County, Tennessee, and Incorporated Areas
                                             Docket No.: FEMA-B-1185
----------------------------------------------------------------------------------------------------------------
East Camp Creek......................  Approximately 1,110 feet                    +453  City of Gallatin.
                                        downstream of U.S. Route 31.
                                       At the downstream side of                   +486
                                        State Route 25.
North Donoho Branch..................  At the upstream side of the                 +794  City of Portland.
                                        railroad.
                                       Approximately 0.6 mile                      +794
                                        upstream of the railroad.
Sink Hole Creek......................  At the downstream side of                   +475  City of Gallatin,
                                        Newton Lane.                                      Unincorporated Areas
                                                                                of Sumner County.
                                       Approximately 0.4 mile                      +571
                                        upstream of Airport Driveway.
Sink Hole Creek Tributary............  Approximately 320 feet                      +498  City of Gallatin,
                                        upstream of the Sink Hole                         Unincorporated Areas
                                        Creek confluence.                                 of Sumner County.
                                       Approximately 580 feet                      +547
                                        upstream of Airport Road.

Station Camp Creek...................  At the upstream side of Lower               +452  City of Gallatin, City
                                        Station Camp Road.                                of Hendersonville,
                                                                                Unincorporated Areas
                                                                                of Sumner County.
                                       Approximately 0.8 mile                      +554
                                        downstream of the Strother
                                        Branch confluence.
----------------------------------------------------------------------------------------------------------------
* National Geodetic Vertical Datum.
+ North American Vertical Datum.
 Depth in feet above ground.
[caret] Mean Sea Level, rounded to the nearest 0.1 meter.

                                                    ADDRESSES

City of Gallatin
Maps are available for inspection at City Hall, 132 West Main Street, Gallatin, TN 37066.

City of Hendersonville
Maps are available for inspection at City Hall, Planning and Zoning, 1 Executive Park Drive, Hendersonville, TN
 37075.

City of Portland
Maps are available for inspection at City Hall, 100 South Russell Street, Portland, TN 37148.

                                      Unincorporated Areas of Sumner County
Maps are available for inspection at the Sumner County Building Department, 355 North Belvedere Drive, Room 202,
 Gallatin, TN 37066.
----------------------------------------------------------------------------------------------------------------

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

    Dated: March 22, 2012.
Sandra K. Knight,
Deputy Associate Administrator for Mitigation, Department of Homeland
Security, Federal Emergency Management Agency.
[FR Doc. 2012-8568 Filed 4-9-12; 8:45 am]
BILLING CODE 9110-12-P


BEFORE THE

DEPARTMENT OF TRANSPORTATION

WASHINGTON, D.C.

__________________________________________

Applications of					)

							)

	CORPORATE AIRLINES, INC.		)

	OZARK AIRLINES, INC.			)

	   d/b/a GREAT PLAINS AIRLINES	)

	AMERICAN TRANS AIR, INC.		)

	MIDWEST EXPRESS AIRLINES, INC.	)		Docket OST-2000-7182

	AIRTRAN AIRWAYS, INC.		)

	US AIRWAYS, INC.				)

							)

For exemptions from 14 C.F.R. Part 93,		)

Subparts K and S, pursuant to 49 U.S.C.		)

§ 41718(b), Special Rules for Ronald Reagan	)

Washington National Airport (within-perimeter	)

slot exemptions)					)

__________________________________________)

AIRTRAN AIRWAYS, INC. NOTIFICATION TO THE DOCKET

Communications with respect to this document should be addressed to:

Richard P. Magurno					Edward P. Faberman

Senior Vice President & General Counsel 		Ungaretti & Harris

AirTran Airways					1500 K Street NW, Suite 250

9955 AirTran Boulevard				Washington, DC 20005-1714

Orlando, FL 32827					Tel:<PHONE_NUMBER>

							Fax:<PHONE_NUMBER>

Kevin P. Healy

Vice President-Planning				Counsel for AirTran Airways

AirTran Airways, Inc.

9955 AirTran Boulevard

Orlando, FL 32827

October 13, 2003

BEFORE THE

DEPARTMENT OF TRANSPORTATION

WASHINGTON, D.C.

__________________________________________

Applications of					)

							)

	CORPORATE AIRLINES, INC.		)

	OZARK AIRLINES, INC.			)

	   d/b/a GREAT PLAINS AIRLINES	)

	AMERICAN TRANS AIR, INC.		)

	MIDWEST EXPRESS AIRLINES, INC.	)		Docket OST-2000-7182

	AIRTRAN AIRWAYS, INC.		)

	US AIRWAYS, INC.				)

							)

For exemptions from 14 C.F.R. Part 93,		)

Subparts K and S, pursuant to 49 U.S.C.		)

§ 41718(b), Special Rules for Ronald Reagan	)

Washington National Airport (within-perimeter	)

slot exemptions)					)

__________________________________________)

AIRTRAN AIRWAYS, INC. NOTIFICATION TO THE DOCKET

	On August 20, 2003, AirTran Airways, Inc. (“AirTran”) notified US
Airways, Inc. and all parties that it would initiate service with the
four (4) Ronald Reagan Washington National Airport (“DCA”) slots
allocated to it under the Department of Transportation (“DOT”) Order
2003-1-16.

On August 19, 2003, AirTran announced that it would launch one (1) daily
nonstop flight between DCA and Ft. Lauderdale (“FLL”) and one (1)
daily nonstop flight between DCA and Fort Myers (“RSW”) on October
23, 2003.

Consistent with Order 2003-1-16, on December 4, 2003, AirTran will
initiate DCA service to West Palm Beach while ending DCA service to Ft.
Lauderdale.  Therefore, effective December 4, 2003, AirTran will operate
one roundtrip (two slots) to West Palm Beach in addition to one
roundtrip (two slots) to Fort Myers.  AirTran’s flights to/from DCA
will operate using new Boeing 717 aircraft, the most modern, quiet and
environmentally friendly aircraft flying today.

					Respectfully submitted,

Edward P. Faberman

						UNGARETTI & HARRIS

						1500 K Street, N.W., Suite 250

						Washington, D.C. 20005-1714

						Tel:<PHONE_NUMBER>

						Fax:<PHONE_NUMBER>

						Counsel for AirTran Airways

October 13, 2003

CERTIFICATE OF SERVICE

I hereby certify that a copy of the AirTran Airways, Inc. Notification
to the Docket was served on October 13, 2003 to the following listed
below.

						__________________________________

						Sonia S. Pak

The Honorable Mark R. Warner

Governor

Commonwealth of Virginia

State Capitol, 3rd Floor

Richmond, VA 23219

Christopher Brown

Airport Manager

Ronald Reagan Washington National Airport

Washington, DC 20001

Bruce V. Pelly

Director, Palm Beach County

Department of Airports

Building 846

Pal Beach International Airport

West Palm Beach, FL 33406

  HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>
  HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>
  HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>
  HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>
  HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>
  HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>
  HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>
  HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>
  HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>
  HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>
  HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>
  HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>
  HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>
  HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>
  HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>
  HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>
  HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>
  HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>
  HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>

  PAGE  3


[Federal Register Volume 77, Number 38 (Monday, February 27, 2012)]
[Notices]
[Pages 11554-11555]
[FR Doc No: 2012-4424]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0621]

Final Decision on Withdrawal of Breast Cancer Indication for
AVASTIN (Bevacizumab) Following Public Hearing; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the final decision withdrawing approval of the breast
cancer indication for AVASTIN (Bevacizumab). The Commissioner of Food
and Drugs (the Commissioner) issued the decision following a June 2011
public hearing on a proposal to withdraw the approval.

DATES: Withdrawal of AVASTIN's breast cancer indication was effective
November 18, 2011.

ADDRESSES: Submit written requests for single copies of the decision to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 2201, Silver Spring, MD 20993-0002. The final decision, hearing
transcript, and other documents may be seen in the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1601, Rockville, MD 20852. See the SUPPLEMENTARY INFORMATION
section for electronic access to the decision and related documents.

FOR FURTHER INFORMATION CONTACT: Sharon Sickafuse, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    On February 22, 2008, FDA's Center for Drug Evaluation and Research
(CDER) approved a supplemental biologics license application (sBLA
125085/91) submitted by Genentech, Inc. (Genentech), for the use of
AVASTIN in combination with paclitaxel for patients who have not
received chemotherapy for treatment of HER2-negative metastatic breast
cancer (MBC). This approval was issued under the Agency's accelerated
approval regulations for biological products, 21 CFR part 601, subpart
E. Consistent with those regulations, the approval was

subject to the requirement that the product be studied further to
verify and describe its clinical benefit. On November 16, 2009,
Genentech submitted the results of two clinical trials intended to
satisfy this requirement. CDER determined that these trials failed to
verify AVASTIN's clinical benefit in the treatment of MBC and on
December 16, 2010, issued a notice of opportunity for a hearing to
Genentech proposing to withdraw approval of AVASTIN's MBC indication.
Genentech submitted a hearing request dated December 23, 2010, followed
by a submission of data and information on which it would rely at a
hearing. The Agency granted Genentech's hearing request and published a
notice of hearing on May 11, 2011 (76 FR 27332). The hearing was held
on June 28 and 29, 2011. Following the hearing, on November 18, 2011,
the Commissioner issued a final decision withdrawing approval of
AVASTIN's MBC indication.

II. Electronic Access

    Persons with access to the Internet may obtain the final decision
at http://www.fda.gov/downloads/NewsEvents/Newsroom/UCM280546.pdf. The
final decision, a transcript of the hearing, and other documents
pertaining to the withdrawal of Avastin's MBC indication are available
at http://www.regulations.gov under the docket number found in brackets
in the heading of this document.

    Dated: February 21, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-4424 Filed 2-24-12; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 78, Number 232 (Tuesday, December 3, 2013)]
[Notices]
[Page 72668]
[FR Doc No: 2013-28899]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 13728-002]

Goodwin Power, LLC; Notice of Preliminary Permit Application
Accepted for Filing and Soliciting Comments, Motions To Intervene, and
Competing Applications

    On November 8, 2013, Goodwin Power, LLC filed an application for a
successive preliminary permit, pursuant to section 4(f) of the Federal
Power Act (FPA), proposing to study the feasibility proposing to study
the feasibility of the Goodwin Dam Project, located on the Stanislaus
River in Tuolumne and Calaveras counties, California. The sole purpose
of a preliminary permit, if issued, is to grant the permit holder
priority to file a license application during the permit term. A
preliminary permit does not authorize the permit holder to perform any
land-disturbing activities or otherwise enter upon lands or waters
owned by others without the owners' express permission.
    The proposed project would be located at the existing Goodwin Dam
\1\ and would harness water that currently flows over the spillway of
the Goodwin Dam. The proposed project would consist of: (1) A 15-foot-
wide by 7-foot-high siphon intake and guard; (2) four 150-foot-long, 48
inch diameter penstocks; (3) four inline turbines and associated
generators, each having an installed capacity of 1.24 megawatts; (4)
four 48-inch-wide draft tube tunnels; (5) a 33-foot-long by 25-foot-
wide concrete foundation; (6) a 50-foot-long by 20-foot-wide tailrace
canal extending from the powerhouse to the river bed; (7) a new
switchyard and 400-foot-long, 17 kV transmission overhead line or a
buried cable connecting to PG&E[acute]s transmission lines at Goodwin
Dam; and (8) appurtenant facilities.
---------------------------------------------------------------------------

    \1\ The existing Goodwin Dam is owned by the Oakdale Irrigation
District and San Joaquin Irrigation District.
---------------------------------------------------------------------------

    Applicant Contact: Magn[uacute]s J[oacute]hannesson, America
Renewables, LLC; 46-E Peninsula Center, Palos Verdes Estates, CA 90274;
<EMAIL_ADDRESS>    FERC Contact: Jennifer Adams,<PHONE_NUMBER>;
<EMAIL_ADDRESS>    Deadline for filing comments, motions to intervene, competing
applications (without notices of intent), or notices of intent to file
competing applications: 60 days from the issuance of this notice.
Competing applications and notices of intent must meet the requirements
of 18 CFR 4.36. Comments, motions to intervene, notices of intent, and
competing applications may be filed electronically via the Internet.
See 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's
Web site http://www.ferc.gov/docs-filing/efiling.asp. Commenters can
submit brief comments up to 6,000 characters, without prior
registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact information
at the end of your comments. For assistance, please contact FERC Online
Support at<EMAIL_ADDRESS>or toll free at 1-866-208-3676,
or for TTY,<PHONE_NUMBER>. Although the Commission strongly encourages
electronic filing, documents may also be paper-filed. To paper-file,
mail an original and five copies to: Kimberly D. Bose, Secretary,
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426.
    More information about this project, including a copy of the
application, can be viewed or printed on the ``eLibrary'' link of the
Commission's Web site at http://www.ferc.gov/docs-filing/elibrary.asp.
Enter the docket number (P-13728) in the docket number field to access
the document. For assistance, contact FERC Online Support.

    Dated: November 26, 2013.
 Kimberly D. Bose,
 Secretary.
[FR Doc. 2013-28899 Filed 12-2-13; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: May 3, 2010 (Volume 75, Number 84)]
[Notices]
[Page 23311]
[DOCID:fr03my10-95]

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

SECURITIES AND EXCHANGE COMMISSION

[Rule 19d-1; SEC File No. 270-242; OMB Control No. 3235-0206]

Proposed Collection; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of Investor Education and Advocacy, Washington, DC
20549-0213.

    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.) the Securities and Exchange Commission
(``Commission'') is soliciting comments on the existing collection of
information provided for in Rule 19d-1 (17 CFR 240.19d-1)--Notices by
Self-Regulatory Organizations of Final Disciplinary Actions, Denials
Bars, or Limitations Respecting Membership, Association, or Access to
Services, and Summary Suspensions. The Commission plans to submit this
existing collection of information to the Office of Management and
Budget for extension and approval.
    Rule 19d-1 (``Rule'') under the Securities Exchange Act of 1934 (17
U.S.C. 78a et seq.) prescribes the form and content of notices to be
filed with the Commission by self-regulatory organizations (``SROs'')
for which the Commission is the appropriate regulatory agency
concerning the following final SRO actions: (1) Disciplinary sanctions
(including summary suspensions); (2) denials of membership,
participation or association with a member; and (3) prohibitions or
limitations on access to SRO services.
    The Rule enables the Commission to obtain reports from the SROs
containing information regarding SRO determinations to discipline
members or associated persons of members, deny membership or
participation or association with a member, and similar adjudicated
findings. The Rule requires that such actions be promptly reported to
the Commission. The Rule also requires that the reports and notices
supply sufficient information regarding the background, factual basis
and issues involved in the proceeding to enable the Commission: (1) To
determine whether the matter should be called up for review on the
Commission's own motion; and (2) to ascertain generally whether the SRO
has adequately carried out its responsibilities under the Exchange Act.
    It is estimated that 10 respondents will utilize this application
procedure annually, with a total burden of 1,175 hours, based upon past
submissions. This figure is based on 10 respondents, spending
approximately 117.5 hours each per year. Each respondent submitted
approximately 235 responses. The staff estimates that the average
number of hours necessary to comply with the requirements of Rule 19d-1
for each submission is 0.5 hours. The average cost per hour, per each
submission is approximately $101. Therefore, the total cost of
compliance for all the respondents is $118,675. (10 respondents x 235
responses per respondent x .5 hrs per response x $101 per hour).
    Written comments are invited on: (a) Whether the proposed
collection of information is necessary for the proper performance of
the functions of the Commission, including whether the information
shall have practical utility; (b) the accuracy of the Commission's
estimates of the burden of the proposed collection of information; (c)
ways to enhance the quality, utility and clarity of the information to
be collected; and (d) ways to minimize the burden of the collection of
information on respondents, including through the use of automated
collection techniques or other forms of information technology.
Consideration will be given to comments and suggestions submitted in
writing within 60 days of this publication.
    Direct your written comments to Charles Boucher, Director/Chief
Information Officer, Securities and Exchange Commission, c/o Shirley
Martinson, 6432 General Green Way, Alexandria, VA 22312 or send an e-
mail to<EMAIL_ADDRESS>
    Dated: April 26, 2010.
Florence E. Harmon,
Deputy Secretary.
[FR Doc. 2010-10215 Filed 4-30-10; 8:45 am]
BILLING CODE 8010-01-P


[Federal Register: March 28, 2007 (Volume 72, Number 59)]
[Notices]
[Page 14628-14629]
[DOCID:fr28mr07-139]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-55505; File No. 4-523]

Program for Allocation of Regulatory Responsibilities Pursuant to
Rule 17d-2; Notice of Filing and Order Approving and Declaring
Effective a Revised Plan for Allocation of Regulatory Responsibilities
Between NYSE Arca, Inc. and the National Association of Securities
Dealers, Inc.

March 22, 2007.
    Pursuant to Sections 17(d) \1\ and 11A(a)(3)(B) \2\ of the
Securities Exchange Act of 1934 (``Act''), the Securities and Exchange
Commission (``Commission'') is hereby providing notice of filing and
issuing an order granting approval and declaring effective a revised
plan for the allocation of regulatory responsibilities dated February
9, 2007 (``Revised Plan'') that was filed pursuant to Rule 17d-2 under
the Act\3\ by NYSE Arca, Inc. (``NYSE Arca'') and the National
Association of Securities Dealers, Inc. (``NASD'') (together with the
NYSE Arca, the ``Parties''). The Revised Plan replaces and supersedes
the agreement entered into between the Parties on July 25, 2006 (``July
2006 Plan'')\4\ in its entirety. The Revised Plan, which makes minor
changes to the July 2006 Plan, does not fundamentally alter the
allocation of regulatory responsibilities between the Parties.\5\
Accordingly, in addition to the regulatory responsibility it has under
the Act, NASD shall retain the regulatory responsibilities allocated to
it under the Revised Plan. At the same time, NYSE Arca continues to be
relieved of those regulatory responsibilities allocated to NASD under
the Revised Plan.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78q(d).
    \2\ 15 U.S.C. 78k-1(a)(3)(B).
    \3\ 17 CFR 240.17d-2.
    \4\ See Securities Exchange Act Release Nos. 54224 (July 27,
2006), 71 FR 43823 (August 2, 2006) (notice) and 54394 (August 31,
2006), 71 FR 52827 (September 7, 2006) (order).
    \5\ The text of the Revised Plan is available at the principal
offices of NYSE Arca and NASD and at the Commission's Public
Reference Room.
---------------------------------------------------------------------------

I. Introduction

    Section 19(g)(1) of the Act,\6\ among other things, requires every
self-regulatory organization (``SRO'') registered as either a national
securities exchange or registered securities association to examine
for, and enforce compliance by, its members and persons associated with
its members with the Act, the rules and regulations thereunder, and the
SRO's own rules, unless the SRO is relieved of this

responsibility pursuant to Section 17(d) \7\ or 19(g)(2) \8\ of the
Act. Section 17(d)(1) of the Act\9\ was intended, in part, to eliminate
unnecessary multiple examinations and regulatory duplication for those
broker-dealers that maintain memberships in more than one SRO (``common
members'').\10\ With respect to a common member, Section 17(d)(1)
authorizes the Commission, by rule or order, to relieve an SRO of the
responsibility to receive regulatory reports, to examine for and
enforce compliance with applicable statutes, rules, and regulations, or
to perform other specified regulatory functions.
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78s(g)(1).
    \7\ 15 U.S.C. 78q(d).
    \8\ 15 U.S.C. 78s(g)(2).
    \9\ 15 U.S.C. 78q(d)(1).
    \10\ See Securities Act Amendments of 1975, Report of the Senate
Committee on Banking, Housing, and Urban Affairs to Accompany S.
249, S. Rep. No. 94-75, 94th Cong., 1st Session 32 (1975).
---------------------------------------------------------------------------

    To implement Section 17(d)(1), the Commission adopted two rules:
Rule 17d-1\11\ and Rule 17d-2 under the Act.\12\ Rule 17d-2 permits
SROs to propose joint plans for the allocation of regulatory
responsibilities, other than financial responsibility rules, with
respect to their common members. Under paragraph (c) of Rule 17d-2, the
Commission may declare such a plan effective if, after providing for
appropriate notice and comment, it determines that the plan is
necessary or appropriate in the public interest and for the protection
of investors, to foster cooperation and coordination among the SROs, to
remove impediments to, and foster the development of, a national market
system and a national clearance and settlement system, and is in
conformity with the factors set forth in Section 17(d) of the Act. Upon
effectiveness of a plan filed pursuant to Rule 17d-2, an SRO is
relieved of those regulatory responsibilities for common members that
are allocated by the plan to another SRO.
---------------------------------------------------------------------------

    \11\ 17 CFR 240.17d-1. Rule 17d-1 authorizes the Commission to
name a single SRO as the designated examining authority (``DEA'') to
examine common members for compliance with the financial
responsibility requirements imposed by the Act, or by Commission or
SRO rules.
    \12\ 17 CFR 240.17d-2.
---------------------------------------------------------------------------

    The Revised Plan, which makes minor changes to the July 2006 Plan
(and replaces and supersedes the July 2006 Plan in its entirety), is
intended to reduce regulatory duplication for firms that are common
members of NYSE Arca and NASD. Except as noted immediately below, the
Revised Plan retains the same allocation of regulatory responsibilities
among the Parties with respect to common members as the July 2006 Plan.
In particular, the Revised Plan: (1) Eliminates paragraph 11 of the
July 2006 Plan that allocated to NASD the responsibility to receive and
act upon requests for extension of time pursuant to Federal Reserve
Regulation T and Rule 15c3-3 under the Act, since the monitoring of
such requirements is the obligation of a member's DEA as provided by
Rule 17d-1 under the Act; \13\ (2) changes from ``monthly'' to ``upon
request'' the obligation of NASD to share information with NYSE Arca
regarding notice of changes in allied members, partners, officers,
registered personnel and other persons, and the opening, address
change, and termination of main and branch offices and the names of
branch office managers; \14\ and (3) makes other technical and
formatting changes, such as renumbering paragraphs and reformatting
headings.
---------------------------------------------------------------------------

    \13\ 17 CFR 240.17d-1. Further, NYSE Arca represents that it
currently does not serve as the DEA for any firms that hold or carry
customer accounts, and therefore does not currently perform any
duties pursuant to Regulation T and Rule 15c3-3 with respect to
considering requests for extension of time. See Telephone
conversation between Greg O'Connor, Director, NYSE Group, Inc., and
Richard Holley III, Special Counsel, Division of Market Regulation,
Commission, on March 16, 2007. Additionally, Paragraph 2(c) of the
July 2006 Plan, as well as the Revised Plan, provides that NYSE Arca
retains full responsibility for the discharge of its DEA duties and
obligations. Accordingly, NASD did not undertake any
responsibilities pursuant to paragraph 11 of the July 2006 Plan and
the Parties consider the deletion of paragraph 11 to be a non-
material change. See id.
    \14\ See Paragraph 7 of the Revised Plan.
---------------------------------------------------------------------------

    Included in the Revised Plan is an attachment (``NYSE Arca Rules
Certification for 17d-2 Agreement with NASD,'' referred to herein as
the ``Certification'') that lists every NYSE Arca rule and federal
securities law, rule and regulation thereunder for which, under the
Revised Plan, NASD would bear responsibility for examining, and
enforcing compliance by, common members. No changes to the
Certification are proposed in the Revised Plan.

II. Discussion

    The Commission finds that the Revised Plan is consistent with the
factors set forth in Section 17(d) of the Act \15\ and Rule 17d-2(c)
thereunder \16\ in that the Revised Plan is necessary or appropriate in
the public interest and for the protection of investors, fosters
cooperation and coordination among SROs, and removes impediments to and
fosters the development of the national market system. In particular,
the Revised Plan makes minor changes to the July 2006 Plan and does not
fundamentally alter the allocation of regulatory responsibilities
between the Parties that was contained in the July 2006 Plan.
Additionally, no changes to the Certification are proposed in the
Revised Plan.
---------------------------------------------------------------------------

    \15\ 15 U.S.C. 78q(d).
    \16\ 17 CFR 240.17d 2(c).
---------------------------------------------------------------------------

    As was the case for the July 2006 Plan, the Commission continues to
believe that the Revised Plan could reduce unnecessary regulatory
duplication by allocating to NASD certain responsibilities for common
members that would otherwise be performed by both NYSE Arca and NASD.
Accordingly, the Revised Plan should promote efficiency by reducing
costs to common members. Furthermore, because NYSE Arca and NASD will
coordinate their regulatory functions in accordance with the Revised
Plan, the Revised Plan should promote investor protection.
    The Commission is hereby declaring effective and approving a plan
that, among other things, allocates regulatory responsibility to NASD
for the oversight and enforcement of all NYSE Arca rules that are
substantially similar to the rules of the NASD for common members of
NYSE Arca and NASD.

III. Conclusion

    This Order gives effect to the Revised Plan filed with the
Commission in File No. 4-523. The Parties shall notify all members
affected by the Revised Plan of their rights and obligations under the
Revised Plan.
    It is therefore ordered, pursuant to Sections 17(d) and
11A(a)(3)(B) of the Act, that the Revised Plan in File No. 4-523,
between NYSE Arca and NASD, filed pursuant to Rule 17d-2 under the Act,
is approved and declared effective.
    It is therefore ordered that NYSE Arca is relieved of those
responsibilities allocated to NASD under the Revised Plan in File No.
4-523.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority. \17\
---------------------------------------------------------------------------

    \17\ 17 CFR 200.30-3(a)(34).
---------------------------------------------------------------------------

Florence E. Harmon,
Deputy Secretary.
[FR Doc. E7-5637 Filed 3-27-07; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 84, Number 97 (Monday, May 20, 2019)]
[Notices]
[Pages 22916-22919]
[FR Doc No: 2019-10352]

=======================================================================
-----------------------------------------------------------------------

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-85855; File No. SR-C2-2019-010]

Self-Regulatory Organizations; Cboe C2 Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of a Proposed Rule Change To Add
Certain Fees Related to the Listing and Trading of Options Contracts on
the Dow Jones Industrial Average Index (``DJX'')

May 14, 2019.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the

``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on May 7, 2019, Cboe C2 Exchange, Inc. (the ``Exchange'' or ``C2'')
filed with the Securities and Exchange Commission (the ``Commission'')
the proposed rule change as described in Items I, II, and III below,
which Items have been prepared by the Exchange. The Commission is
publishing this notice to solicit comments on the proposed rule change
from interested persons.
---------------------------------------------------------------------------

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

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

    Cboe C2 Exchange, Inc. (the ``Exchange'' or ``C2'') proposes to add
certain fees related to the listing and trading of options contracts on
the Dow Jones Industrial Average Index (``DJX''). The text of the
proposed rule change is provided in Exhibit 5.
    The text of the proposed rule change is also available on the
Exchange's website (http://markets.cboe.com/us/options/regulation/rule_filings/ctwo/), at the Exchange's Office of the Secretary, 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, the Proposed Rule Change

1. Purpose
    On May 8, 2019, the Exchange will begin listing DJX options for
trading.\3\ Accordingly, the Exchange proposes to amend its Fee
Schedule to codify standard transaction fees for DJX transactions. The
proposed changes will be effective May 8, 2019.
---------------------------------------------------------------------------

    \3\ See Interpretation and Policy .01 to Rule 24.
---------------------------------------------------------------------------

    Specifically, the Exchange proposes to add various fee codes for
executions and linkage routing in DJX options. The proposed rates
applicable to each proposed fee code for executions and for linkage
routing correspond to the rates that currently apply to the same
execution and linkage routing types in the Russell 2000 Index options
(``RUT''). The Exchange also proposes to amend the Index License
Surcharge fees that apply to all non-Public Customer transactions to
include a fee for DJX.
    Regarding executions in DJX options, fee code DC will be appended
to all Public Customer orders executed in DJX options, and will result
in a rate of $0.15 per contract. Fee code DM will be appended to all C2
Market-Maker orders executed in DJX options, and will result in a rate
of $0.35 per contract. Fee code DN will be appended to Non-Customer and
Non-Market-Maker orders executed in DJX options, and will result in a
rate of $0.55 per contract. Fee code DO will be appended to trades
executed on the open in DJX options, and will be free. The proposed
fees assessed are the same for corresponding execution types in RUT.
    Regarding linkage routing fees for orders routed away to another
exchange in DJX, fee code FC will be appended to all routed Customer
orders in DJX options, and will result in a fee of $0.85. Fee code FM
will be appended to all routed Market-Marker orders in DJX options, and
will result in a fee of $1.05. Fee code FN will be appended to all
routed Non-Customer and Non-Market-Maker orders in DJX options, and
will result in a fee of $1.25. Fee code FO will be appended to all
order routed at the open in DJX, and will be free. The proposed fees
assessed are the same for corresponding linkage routing types in RUT.
    As stated, the Exchange also proposes to amend the Index License
Surcharge fee, which is applicable to all non-Public Customer
transactions, to include a fee of $0.10 per contract assessed for
transactions in DJX options. The Exchange proposes to assess a
Surcharge of $0.10 per contract in order to recoup the costs associated
with the DJX license.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the Section 6 of the Act,\4\ in general, and Section 6(b)(4),\5\
in particular, as it is designed to provide for the equitable
allocation of reasonable dues, fees and other charges among its Trading
Permit Holders (``TPHs'') and other persons using its facilities.
---------------------------------------------------------------------------

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

    Specifically, the Exchange believes it is reasonable to charge
different fee amounts to different user types for executions and
linkage routing in DJX options in the manner proposed because the
proposed fees are consistent with the price differentiation and type of
TPH transactions that exists today on the Exchange for another index
option product, RUT, as well as on its affiliated exchange, Cboe
Exchange, Inc. (``Cboe Options'') for index option products, which
includes DJX options.\6\ Additionally, the Exchange believes the
proposed fee amounts for DJX executions and linkage routing are
reasonable because the proposed fee amounts correspond to the fee
amounts charged for executions and linkage routing in RUT on the
Exchange today. In addition to this, the Exchange believes that the
proposed surcharge for DJX options is reasonable because a similar
surcharge exists on the Exchange today for RUT options (which is higher
than the proposed surcharge for DJX). The Exchange also notes that Cboe
Options currently assesses a $0.10 surcharge fee for DJX options.\7\
Furthermore, the Exchange believes that the proposed fees for the newly
listed DJX options on C2 are reasonable as the Exchange's affiliated
exchange, Cboe BZX Exchange, Inc. (``BZX Options'') recently added
comparable execution, linkage routing and surcharge fees for a newly
listed index option product, RUT.\8\ The Exchange believes these types
of fee codes for newly or recently listed index options are reasonable
because they promote and encourage trading in such products.
---------------------------------------------------------------------------

    \6\ See Cboe Options Fees Schedule, Index Options Rate Table.
    \7\ Id.
    \8\ See Securities Exchange Act Release No. 84401 (October, 11,
2018), 83 FR 52591 (October 17, 2018) (Notice of Filing and
Immediate Effectiveness of a Proposed Rule Change Related to Fees on
Cboe BZX Exchange, Inc.) (SR-CboeBZX-2018-075).
---------------------------------------------------------------------------

    The Exchange also believes that it is equitable and not unfairly
discriminatory to assess lower fees for executions and linkage routing
to Customers (including Public Customers) as compared to other market
participants because Customer order flow enhances liquidity on the
Exchange for the benefit of all market participants. Specifically,
Customer liquidity benefits all market participants by providing more
trading opportunities, which attracts Market-Makers. An increase in the
activity of these market participants in turn facilitates tighter
spreads, which may cause an additional corresponding increase in order
flow from other market participants. Moreover, the options industry has
a long history of providing preferential pricing to Customers, and the
Exchange's current Fee Schedule

currently does so in many places, as do the fees structures of multiple
other exchanges.\9\ The Exchange notes that all fee amounts applicable
to Customers will be applied equally to all Customers, i.e. all
Customers will be assessed the same amount.
---------------------------------------------------------------------------

    \9\ See e.g. supra note 6. See also BZX Options Fee Schedule,
Fee Codes and Associated Fees.
---------------------------------------------------------------------------

    Additionally, the Exchange believes that it is equitable and not
unfairly discriminatory to assess lower fees for executions and linkage
routing to Market-Makers as compared to other market participants,
other than Customers, because Market-Makers, unlike other market
participants, take on a number of obligations, including quoting
obligations, which other market participants do not have. Further,
these lower fees offered to Market-Makers are intended to incent
Market-Makers to quote and trade more on C2 Options, thereby providing
more trading opportunities for all market participants. The Exchange
notes that all fee amounts applicable to Market-Makers will be applied
equally to all Market-Makers, i.e. all Market-Makers will be assessed
the same amount. Similarly, the Exchange notes that the DJX fee amounts
for each separate type of other market participant will be assessed
equally to all such market participants, i.e. all Non-Customer and Non-
Market-Maker orders will be assessed the same amount.
    The Exchange believes its proposed fees for DJX orders that are
routed away from the Exchange are reasonable taking into account
routing costs and also notes that the proposed fees are in line with
amounts assessed by other exchanges.\10\ For the reasons described
above, the Exchange also believes that it is equitable and not unfairly
discriminatory to assess lower routing fees to Customers as compared to
other market participants. The Exchange notes that routing through the
Exchange is voluntary and market participants can readily direct order
flow to another exchange if they deem Exchange fee levels to be
excessive.
---------------------------------------------------------------------------

    \10\ See supra note 9.
---------------------------------------------------------------------------

    Finally, the Exchange believes that it is reasonable to asses an
Index License Surcharge fee to all non-Public Customer transactions
because the surcharge helps recoup some of the costs associated with
the license for DJX. As previously stated, the Exchange notes that the
surcharge amount is the same as the amount assessed on other exchanges
and lower than the amount assessed for RUT options on the Exchange. The
proposed Surcharge is also equitable and not unfairly discriminatory
because the amount will be assessed to all market participants to whom
the Surcharge applies. Not applying the DJX License Surcharge fee to
Public Customer orders is equitable and not unfairly discriminatory
because this is designed to attract Customer DJX option orders, which
increases liquidity and provides greater trading opportunities to all
market participants.

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

    The Exchange believes the proposed amendments to its Fee Schedule
will not impose any burden on competition that is not necessary or
appropriate in furtherance of the purposes of the Act. The Exchange
does not believe that the proposed rule change will impose any burden
on intramarket competition that is not necessary or appropriate in
furtherance of the purposes of the Act because the DJX fee amounts for
each separate type of market participant will be assessed equally to
all such market participants. While different fees are assessed to
different market participants in some circumstances, the obligations
and circumstances between these market participants differ, as
discussed above. For example, Market-Makers have quoting obligations
that are not applicable to other market participants. Further, the
proposed fees structure for DJX is intended to encourage more trading
of DJX, which brings liquidity to the Exchange and benefits all market
participants.
    The Exchange also does not believe that the proposed rule changes
will impose any burden on intermarket competition that is not necessary
or appropriate in furtherance of the purposes of the Act because the
proposed DJX fees are in line with amounts assessed for index option
products by other exchanges. The Exchange notes that to the extent that
the proposed fee rates and rebates for certain orders in DJX options
make the Exchange a more attractive venue for market participants than
other exchanges, market participants are welcome to become TPHs and
execute such orders on the Exchange. Also, as stated, market
participants are free to direct order flow to other competing venues if
they deem the Exchange's fees excessive.

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 written comments from TPHs or other interested parties.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A) of the Act \11\ and paragraph (f) of Rule 19b-4 \12\
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. If the Commission
takes such action, the Commission will institute proceedings to
determine whether the proposed rule change should be approved or
disapproved.
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78s(b)(3)(A).
    \12\ 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 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-C2-2019-010 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-C2-2019-010. 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 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 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 the Exchange. 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-C2-2019-010 and should be
submitted on or before June 10, 2019.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\13\
---------------------------------------------------------------------------

    \13\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Eduardo A. Aleman,
Deputy Secretary.
[FR Doc. 2019-10352 Filed 5-17-19; 8:45 am]
 BILLING CODE 8011-01-P


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

EPA Registration Division contact: Susan Lewis;<PHONE_NUMBER>

Interregional Research Project Number 4 (IR-4)

Petition 4E8337

	EPA has received a pesticide petition (4E8337) from Interregional
Research Project No. 4 (IR-4), 500 College Road East, Suite 201 W,
Princeton, NJ 08540 requesting, 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 by establishing a tolerance for residues of
carfentrazone-ethyl
(ethyl--2-dichloro-5-[4-(difluoromethyl)-4,5-dihydro-3-methyl-5-oxo-1
H-1,2,4-triazol-1-yl]-4-fluorobenzene-propanoate) and the metabolite
carfentrazone-ethyl chloropropionic acid (α,
2-dichloro-5-[4-(difluoromethyl)-4,5-dihydro-3-methyl-5-oxo-1H-1,2,4-tri
azol-1-yl]-4-fluorobenzenepropanoic acid)] in or on the raw agricultural
commodity artichoke at 0.1 parts per million (ppm); asparagus at 0.25
ppm; peppermint, tops at 0.25 ppm; spearmint, tops at 0.25 ppm; teff,
grain at 0.25 ppm; teff, forage at 1.00 ppm; teff, hay at 0.30 ppm;
teff, straw at 0.10 ppm; vegetable, bulb, group 3-07 at 0.10 ppm;
vegetable, fruiting, group 8-10 at 0.10 ppm; fruit, citrus, group 10-10
at 0.10 ppm; fruit, pome, group 11-10 at 0.10 ppm; fruit, stone, group
12-12 at 0.10 ppm; caneberry subgroup 13-07A at 0.10 ppm; bushberry
subgroup 13-07B at 0.10 ppm; fruit, small vine climbing, subgroup
13-07F, except fuzzy kiwi fruit at 0.10 ppm; berry, low growing,
subgroup 13-07G at 0.10 ppm; nut, tree, group 14-12 at 0.10 ppm; oilseed
group 20 at 0.20 ppm; grain, cereal forage group 16 at 1.0 ppm; grain,
cereal, hay, group 16 at 0.30 ppm; grain cereal, stover, group 16 at
0.80 ppm; and grain, cereal, straw, group 16 at 3.0 ppm.

In addition, upon approval of the aforementioned tolerances, IR-4
requests 1) to modify the existing tolerance for banana from 0.20 ppm to
0.10 ppm and 2) to remove the following established tolerances:
vegetable, bulb group 3 at 0.10 ppm; vegetable, fruiting, group 8 at
0.10 ppm; fruit, citrus, group 10 at 0.10 ppm; fruit, pome, group 11 at
0.10 ppm; fruit, stone, group 12 at 0.10 ppm; berry group 13 at 0.10
ppm; borage at 0.10 ppm; grape at 0.10 ppm; caneberry subgroup 13A at
0.10 ppm; nut, tree group 14 at 0.10 ppm; pistachio at 0.10 ppm; pummelo
at 0.10 ppm; kiwi fruit at 0.10 ppm; canola at 0.10 ppm; crambe, seed at
0.10 ppm; flax, seed at 0.10 ppm; rapeseed, seed at 0.10 ppm;; okra at
0.10 ppm; safflower seed at 0.10 ppm; salal at 0.10 ppm; cotton,
undelinted seed at 0.20 ppm; sunflower seed at 0.10 ppm; strawberry at
0.10 ppm; juneberry at 0.10 ppm; lingonberry at 0.10 ppm; mustard, seed
at 0.10 ppm; barley bran at 0.80 ppm; barley, flour at 0.80 ppm; corn,
field, forage at 0.20 ppm; corn, sweet, forage at 0.20 ppm, corn, sweet,
kernel plus cob with husk removed at 0.10 ppm; grain, cereal, forage,
fodder and straw group 16, except corn and sorghum; forage at 1.0 ppm;
grain, cereal, forage, fodder and straw, group 16, hay at 0.30 ppm;
grain, cereal, forage, fodder and straw, group 16, stover at 0.30 ppm;
grain, cereal, forage, fodder and straw, group 16, except rice; straw at
0.10 ppm; grain, cereal, group 15 at 0.10 ppm; grain, cereal, stover at
0.80 ppm; grain, cereal, straw at 3.0 ppm; millet, flour at 0.80 ppm;
oat, flour at 0.80 ppm; rice, straw at 1.0 ppm; rye, bran at 0.80 ppm;
rye, flour at 0.80 ppm; sorghum, forage at 0.20 ppm; sorghum, sweet at
0.10 ppm; wheat, bran at 0.80 ppm; wheat, flour at 0.80 ppm; wheat, germ
at 0.80 ppm; wheat, middlings at 0.80 ppm; and wheat, shorts at 0.80
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

	1. Plant metabolism. The metabolism of carfentrazone-ethyl in plants is
adequately understood.  Corn, wheat, radish and soybean metabolism
studies with carfentrazone-ethyl have shown uptake of material into
plant tissue with no significant movement into grain, root or seeds.
All four plants extensively metabolized carfentrazone-ethyl and
exhibited a similar metabolic pathway.  The residues of concern are the
combined residues of carfentrazone-ethyl and carfentrazone-ethyl-
chloropropionic acid.

	2. Analytical method. There is a practical analytical method for
detecting and measuring levels of carfentrazone-ethyl and its metabolite
in or on food with a limit of quantitation that allows monitoring of
food with residues at or above the levels set or proposed in the
tolerances.  The analytical enforcement method for carfentrazone-ethyl
was used with minor modification that eliminated several clean-up and
derivatization steps that was required for GC/MSD but not for
LC/MS/MS.  The analytical method for carfentrazone-ethyl involves
separate analyses for parent and its metabolite.  The parent is
analyzed by evaporation and reconstitution of the sample prior to
analysis by LC/MS/MS GC/ECD.  The metabolite samples were refluxed in
the presence of acid and cleaned up with solid phase extraction prior to
analysis by LC/MS/MS.

	3. Magnitude of residues. The magnitude of the residue of
carfentrazone-ethyl and its major metabolites in/on asparagus treated
with 2 broadcast application to the soil (after clean harvest) at an
interval of 20 (± 2) days with the last application 5 days before
harvesting emergent spears.  Carfentrazone-ethyl formulated as Aim EC or
Aim EW Herbicide was applied at 0.03 lbs ai/A per application using a
spray solution of approximately 10 to 40 gallons of water per acre.

The magnitude of the residue of carfentrazone-ethyl and its major
metabolites in/on mint treated with one broadcast application to emerged
weeds before mint break dormancy.  Carfentrazone-ethyl formulated as Aim
EC or Aim EW Herbicide was applied at 0.015 lbs ai/A to 0.03 lbs ai/A
using a spray solution of approximately 10 to 40 gallons of water per
acre.

RAC for each crop, crop group or subgroup were harvested at the
appropriate time and subsequent analyses determined that the residues of
carfentrazone-ethyl and its metabolites would not exceed the proposed
tolerances.

B. Toxicological Profile

	1. Acute toxicity.  Carfentrazone-ethyl demonstrates low oral, dermal
and inhalation toxicity.  The acute oral LD50 value in the rat was
greater than 5000 mg/kg, the acute dermal LD50 value in the rat was
greater than 4000 mg/kg and the acute inhalation LC50 value in the rat
was greater than 5.09 mg/L/4h.  Carfentrazone-ethyl is non-irritating to
rabbit skin and minimally irritating to rabbit eyes.  It did not cause
skin sensitization in guinea pigs.  An acute neurotoxicity study in the
rat had a systemic NOAEL of 500 mg/kg based on clinical signs and
decreased motor activity levels; the NOAEL for neurotoxicity was greater
than 2000 mg/kg (highest dose tested) based on the lack of neurotoxic
clinical signs or effects on neuropathology.

	2. Genotoxicty. Carfentrazone-ethyl did not cause mutations in the Ames
assay with or without metabolic activation.  There was a positive
response in the Chromosome Aberration assay without activation but a
negative response with activation.  The Mouse Micronucleus assay (an in
vivo test which also measures chromosome damage), the CHO/HGPRT forward
mutation assay and the Unscheduled DNA Synthesis assay were negative.
The overwhelming weight of the evidence supports the conclusion that
Carfentrazone-ethyl is not Genotoxic.

	3. Reproductive and developmental toxicity. Carfentrazone-ethyl is not
considered to be a reproductive or a developmental toxicant.  In the
2-generation reproduction study, the NOEL for reproductive toxicity was
greater than 4000 ppm (greater than 323 to greater than 409 mg/kg/day).
In the developmental toxicity studies, the rat and rabbit maternal NOELs
were 100 mg/kg/day and 150 mg/kg/day, respectively.  The developmental
NOEL for the rabbit was greater than 300 mg/kg /day, which were the
highest dose, tested and for the rat the NOEL was 600 mg/kg/day based on
increased litter incidences of thickened and wavy ribs at 1250
mg/kg/day.  These two findings (thickened and wavy ribs) are not
considered adverse effects of treatment but related delays in rib
development which are generally believed to be reversible.

	4. Subchronic toxicity. Ninety-day feeding studies were conducted in
mice, rats and dogs with Carfentrazone-ethyl.  The NOEL for the mouse
study was 4000 ppm (571 mg/kg/day), for the rat study was 1000 ppm (57.9
mg/kg/day for males; 72.4 mg/kg/day for females) and for dogs was 150
mg/kg/day.  A 90-day subchronic neurotoxicity study in the rat had a
systemic NOEL of 1000 ppm (59.0 mg/kg/day for males; 70.7 mg/kg/day for
females) based on decreases in body weights, body weight gains and food
consumption at 10,000 ppm; the neurotoxicity NOEL was greater than
20,000 ppm (1178.3 mg/kg/day for males; 1433.5 mg/kg/day for females)
which was the highest dose tested.

	5. Chronic toxicity. Carfentrazone-ethyl is not carcinogenic to rats or
mice.  A 2-Year Combined Chronic Toxicity/Oncogenicity study in the rat
was negative for carcinogenicity and had a chronic toxicity NOEL of 200
ppm (9 mg/kg/day) for males and 50 ppm (3 mg/kg/day) for females based
on red fluorescent granules consistent with porphyrin deposits in the
liver at the 500 and 200 ppm levels, respectively.  An 18 Month
Oncogenicity study in the mouse had a carcinogenic NOEL that was greater
than 7000 ppm (>1090 mg/kg/day for males; >1296 mg/kg/day for females)
based on no evidence of carcinogenicity at the highest dose tested.  A
1-Year Oral Toxicity study in the dog had a NOEL of 50 mg/kg/day based
on isolated increases in urine porphyrins in the 150 mg/kg/day group
(this finding was not considered adverse).

Using the Guidelines for Carcinogen Risk Assessment, carfentrazone-ethyl
should be classified as Group AE@ for carcinogenicity -- no evidence of
carcinogenicity -- based on the results of carcinogenicity studies in
two species.  There was no evidence of carcinogenicity in an 18-month
feeding study in mice and a 2-year feeding study in rats at the dosage
levels tested.  The doses tested are adequate for identifying a cancer
risk.  Thus, a cancer risk assessment is not necessary.

	6. Animal metabolism. The metabolism of carfentrazone-ethyl in animals
is adequately understood. Carfentrazone-ethyl was extensively
metabolized and readily eliminated following oral administration to
rats, goats, and poultry via excreta.  All three animals exhibited a
similar metabolic pathway.  As in plants, the parent chemical was
metabolized by hydrolytic mechanisms to predominantly form
carfentrazone-ethyl-chloropropionic acid, which was readily excreted.

	7. Metabolite toxicology. NA - Remove.

	8. Endocrine disruption. An evaluation of the potential effects on the
endocrine systems of mammals has not been determined; however, no
evidence of such effects was reported in the subchronic, chronic or
reproductive toxicology studies described above.  There was no observed
pathology of the endocrine organs in these studies.  There is no
evidence at this time that carfentrazone-ethyl causes endocrine effect.

C. Aggregate Exposure

	1. Dietary exposure. Based on the available toxicity data, the EPA has
established an acute Reference Dose (RfD) for carfentrazone-ethyl of 5
mg/kg/day. The acute RfD is based on acute neurotoxicity study in rats
with a threshold NOEL of 500 mg/kg/day and an uncertainty factor of 100.
A chronic RfD for carfentrazone-ethyl was established at 0.03 mg/kg/day.
 This is based on a 2-year chronic toxicity/carcinogenicity study in
rats with a threshold No-Observed Effect Level (NOEL) of 3 mg/kg/day and
an uncertainty factor of 100.  In support of the proposed harvest-aid
application the Agency conducted acute and chronic dietary risk
assessments using DEEM-FCID, ver 3.16 which incorporates consumption
data from the USDA NHANES/WWEIA; 2003-2008.  For both analysis 100%
crop-treated, DEEM default processing factors and modeled drinking water
estimates resulting from the highest registered proposed application
rate of 0.46 lbs ai/acre, tolerance- level residues for livestock, fish,
shellfish, cereal grains and cotton commodities were made.  Using the
above assumptions, the resulting acute and chronic exposure estimates
were aPAD <1% and cPAD <49% respectively for the most sensitive
sub-population (non-nursing infants <1 year old).

	i. Food. The registered tolerances (40CFR 180.515) and the tolerances
proposed by IR-4 Project subject to this petition (AMENDS 40CFT180.515)
were used as dietary exposure.

Acute dietary exposure: The most conservative acute exposure estimate
was for the population subgroup of non-nursing infants (< 1 year old),
which utilized <1% of the aPAD at the 95th percentile for
carfentrazone-ethyl. The acute drinking water residue of 160 ppb (using
groundwater as the most conservative estimate) was used in the
assessment.   The results show that for all populations, the estimated
exposures are below the Agency's level of concern (< 100% aPAD).

Chronic dietary exposure: The highest chronic exposure estimate was for
the population subgroup of non-nursing infants (<1 year old), which
utilized 49% of the cPAD for carfentrazone-ethyl. The chronic drinking
water residue of 128 ppb (using groundwater as the most conservative
estimate) was used in the assessment.   The results show that for all
populations, the exposures are below the Agency’s level of concern (<
100% cPAD).

Dietary exposure from the proposed harvest-aid application accounts for
1.0% or less of the aPAD in subpopulations (including infants and
children).  Dietary exposure from all uses would accounts for 49% or
less of the cPAD in subpopulations (including infants and children).

	ii. Drinking water. Groundwater estimates of 160 ppb (highest daily
value) and 128 ppb (post-breakthrough average) using the Tier I/II
ground water exposure model, PRZM-GW, exceeded the surface water
estimates (DP Barcode 389083) of 126 ppb (peak exposure) and 48 ppb
(annual average). Therefore, groundwater estimates from PRZM-GW were
incorporated directly into the a  SEQ CHAPTER \h \r 1 cute and chronic
dietary risk assessment to provide a conservative estimate.

	2. Non-dietary exposure. Non-occupational exposures to
carfentrazone-ethyl are anticipated from the lawn, turf and aquatic
applications.  The resulting MOEs were calculated to be >500,000.

D. Cumulative Effects

	EPA is also required to consider the potential for cumulative effects
of carfentrazone-ethyl and other substances that have a common mechanism
of toxicity.  EPA consideration of a common mechanism of toxicity is not
appropriate at this time since EPA does not have information to indicate
that toxic effects produced by carfentrazone-ethyl would be cumulative
with those of any other chemical compounds; thus only the potential
risks of carfentrazone-ethyl are considered in this exposure assessment.

E. Safety Determination

	1. U.S. population. Using the conservative exposure assumptions
described and based on the completeness and reliability of the toxicity
data, the aggregate exposure to carfentrazone-ethyl will utilize less
than 1% of the aPAD and 17% of the cPAD for the general US population.
EPA generally has no concern for exposures below 100 percent of the aPAD
or cPAD.  Therefore, based on the completeness and reliability of the
toxicity data and the conservative exposure assessment, there is a
reasonable certainty that no harm will result from aggregate exposure to
residues of carfentrazone-ethyl, including all anticipated dietary
exposure and all other non-occupational exposures.

	2. Infants and children. In assessing the potential for additional
sensitivity of infants and children to residues of carfentrazone-ethyl,
EPA considers data from developmental toxicity studies in the rat and
rabbit and the two-generation reproduction study in the rat.  The
developmental toxicity studies are designed to evaluate adverse effects
on the developing organism resulting from pesticide exposure during
prenatal development.  Reproduction studies provide information relating
to effects on the reproductive capacity of males and females exposed to
the pesticide.  Developmental toxicity was not observed in developmental
toxicity studies using rats and rabbits.  In these studies, the rat and
rabbit maternal NOELs were 100 mg/kg/day and 150 mg/kg/day,
respectively.  The developmental NOEL for the rabbit was greater than
300 mg/kg/day, which was the highest dose, tested and for the rat was
600 mg/kg/day based on increased litter incidences of thickened and wavy
ribs.  These two findings are not considered adverse effects of
treatment but related delays in rib development, which are generally
believed to be reversible.

In a two-generation reproduction study in rats, no reproductive toxicity
was observed under the conditions of the study at 4000 ppm, which was
the highest dose tested.

FFDCA section 408 provides that EPA may apply an additional safety
factor for infants and children in the case of threshold effects to
account for pre- and post-natal toxicity and the completeness of the
database.  Based on the current toxicological data requirements, the
database relative to pre- and post-natal effects for children is
complete and an additional uncertainty factor is not warranted.
Therefore at this time, the cRfD of 0.03 mg/kg/day is appropriate (cRfD
= cPAD) for assessing aggregate risk to infants and children.

Using the conservative exposure assumptions described above (Tier I
dietary assessment), the percent of the PAD that will be utilized by
aggregate exposure to residues of carfentrazone-ethyl for non-nursing
infants (<1 year old) would be <1% (aPAD) and 49% (cPAD), which
represent the most conservative exposure in all subpopulations.  Based
on the completeness and reliability of the toxicity data and the
conservative exposure assessment, there is a reasonable certainty that
no harm will result to infants and children from aggregate exposure to
the residues of carfentrazone-ethyl including all anticipated dietary
exposure.

F. International Tolerances

h÷d

h÷d

h÷d

%There are no established Codex Alimentarius Commission (Codex) Maximum
Residue Levels (MRLs) for carfentrazone-ethyl, in/on the proposed
commodities.

 PAGE

 PAGE   7