[Federal Register Volume 76, Number 141 (Friday, July 22, 2011)]
[Notices]
[Page 44027]
[FR Doc No: 2011-18459]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-1981-DR; Docket ID FEMA-2011-0001]

North Dakota; Amendment No. 6 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the State of North Dakota (FEMA-1981-DR), dated May 10, 2011, and
related determinations.

DATES: Effective Date: July 13, 2011.

FOR FURTHER INFORMATION CONTACT: Peggy Miller, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street, SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the State of North Dakota is hereby amended to include the
following areas among those areas determined to have been adversely
affected by the event declared a major disaster by the President in his
declaration of May 10, 2011.

    Barnes, Ramsey, and Richland Counties, and the Spirit Lake
Nation for Individual Assistance (already designated for Public
Assistance).

    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households In Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050, Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2011-18459 Filed 7-21-11; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register: April 9, 2010 (Volume 75, Number 68)]
[Rules and Regulations]
[Page 18076-18079]
[DOCID:fr09ap10-15]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

44 CFR Part 65

[Docket ID FEMA-2010-0003]

Changes in Flood Elevation Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Final rule.

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SUMMARY: Modified Base (1% annual-chance) Flood Elevations (BFEs) are
finalized for the communities listed below. These modified BFEs will be
used to calculate flood insurance premium rates for new buildings and
their contents.

DATES: The effective dates for these modified BFEs are indicated on the
following table and revise the Flood Insurance Rate Maps (FIRMs) in
effect for the listed communities prior to this date.

ADDRESSES: The modified 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: Kevin C. Long, Acting Chief,
Engineering Management Branch, Mitigation Directorate, Federal
Emergency Management Agency, 500 C Street, SW., Washington, DC 20472,
(202) 646-2820, or (e-mail<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 BFEs have been published
in newspapers of local circulation and ninety (90) days have elapsed
since that publication. The Deputy Federal Insurance and Mitigation
Administrator has resolved any appeals resulting from this
notification.
    The modified BFEs are not listed for each community in this notice.
However, this final rule includes the address of the Chief Executive
Officer of the community where the modified BFE determinations are
available for inspection.
    The modified BFEs are made pursuant to section 206 of the Flood
Disaster Protection Act of 1973, 42 U.S.C. 4105, and are in accordance
with the National Flood Insurance Act of 1968, 42 U.S.C. 4001 et seq.,
and with 44 CFR part 65.
    For rating purposes, the currently effective community number is
shown and must be used for all new policies and renewals.
    The modified BFEs are the basis for the floodplain management
measures that the community is required either to adopt or to show
evidence of being already in effect in order to qualify or to remain
qualified for participation in the National Flood Insurance Program
(NFIP).
    These modified BFEs, together with the floodplain management
criteria required by 44 CFR 60.3, are the minimum that are required.
They should not be construed to mean that the community must change any
existing ordinances that are more stringent in their floodplain
management requirements. The community may at any time enact stricter
requirements of its own or pursuant to policies established by other
Federal, State, or regional entities.
    These modified BFEs are used to meet the floodplain management
requirements of the NFIP and are also used to calculate the appropriate
flood insurance premium rates for new buildings built after these
elevations are made final, and for the contents in these buildings. The
changes in BFEs are in accordance with 44 CFR 65.4.
    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,
Federalism.
    Executive Order 12988, Civil Justice Reform. This final rule meets
the applicable standards of Executive Order 12988.

List of Subjects in 44 CFR Part 65

    Flood insurance, Floodplains, Reporting and recordkeeping
requirements.

0
Accordingly, 44 CFR part 65 is amended to read as follows:

PART 65--[AMENDED]

0
1. The authority citation for part 65 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.  65.4  [Amended]

0
2. The tables published under the authority of Sec.  65.4 are amended
as follows:

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                                                             Date and name of
         State and county           Location and case No.     newspaper where     Chief executive officer   Effective date of  modification   Community
                                                           notice was published         of community                                             No.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Alabama:
    Autauga (FEMA Docket No: B-     City of Prattville     February 28, 2009;    The Honorable Jim Byard,   February 20, 2009..............       010002
     1046).                          (07-04-6309P).         March 7, 2009;        Jr., Mayor, City of
                                                            Prattville Progress.  Prattville, 101 West
                                                                                Main Street, Prattville,
                                                                                AL 36067.
    Madison (FEMA Docket No: B-     Unincorporated areas   February 6, 2009;     The Honorable Mike         June 15, 2009..................       010151
     1042).                          of Madison County      February 13, 2009;    Gillespie, Chairman,
                                     (09-04-0502P).         Madison County        Madison County
                                                            Record.               Commission, 6994
                                                                                Courthouse, Room 700,
                                                                                100 Northside Square,
                                                                                Huntsville, AL 35801.
Arizona:
    Coconino (FEMA Docket No: B-    Unincorporated areas   February 20, 2009;    The Honorable Deb Hill,    June 29, 2009..................       040019
     1046).                          of Coconino County     February 27, 2009;    Chairman, Coconino
                                     (08-09-1418P).         Arizona Daily Sun.    County Board of
                                                                                Supervisors, 219 East
                                                                                Cherry Avenue,
                                                                                Flagstaff, AZ 86001.
    Maricopa (FEMA Docket No: B-    City of Avondale (08-  March 5, 2009; March  The Honorable Marie        July 10, 2009..................       040038
     1046).                          09-0655P).             12, 2009; Arizona     Lopez, Mayor, City of
                                                            Business Gazette.     Avondale, 11465 West
                                                                                Civic Center Drive,
                                                                                Suite 280, Avondale, AZ
                                                                                85323.
    Maricopa (FEMA Docket No: B-    Unincorporated areas   March 5, 2009; March  The Honorable Andrew       July 10, 2009..................       040037
     1046).                          of Maricopa County     12, 2009; Arizona     Kunasek, Chairman,
                                     (08-09-0655P).         Business Gazette.     Maricopa County Board of
                                                                                Supervisors, 301 West
                                                                                Jefferson Street, 10th
                                                                                Floor, Phoenix, AZ 85003.
    Maricopa (FEMA Docket No: B-    City of Tolleson (08-  March 5, 2009; March  The Honorable Adolfo F.    July 10, 2009..................       040055
     1046).                          09-0655P).             12, 2009; Arizona     Gamez, Mayor, City of
                                                            Business Gazette.     Tolleson, 9555 West Van
                                                                                Buren Street, Tolleson,
                                                                                AZ 85353.
    Maricopa (FEMA Docket No: B-    Town of Cave Creek     February 11, 2009;    The Honorable Vincent      June 18, 2009..................       040129
     1052).                          (09-09-0129P).         February 18, 2009;    Francia, Mayor, Town of
                                                            Sonoran News.         Cave Creek, 37622 North
                                                                                Cave Creek Road, Cave
                                                                                Creek, AZ 85331.
California:
    San Bernardino (FEMA Docket     Town of Apple Valley   February 13, 2009;    The Honorable Mark Shoup,  June 19, 2009..................       060752
     No: B-1044).                    (08-09-1552P).         February 20, 2009;    Mayor, City of Apple
                                                            Apple Valley News.    Valley, 14955 Dale Evans
                                                                                Parkway, Apple Valley,
                                                                                CA 92307.
    San Bernardino (FEMA Docket     City of Hesperia (08-  February 12, 2009;    The Honorable Tad          June 19, 2009..................       060733
     No: B-1044).                    09-1552P).             February 19, 2009;    Honeycutt, Mayor, City
                                                            Hesperia Resorter.    of Hesperia, 9700 7th
                                                                                Avenue, Hesperia, CA
                                                                                92345.
    San Bernardino (FEMA Docket     Unincorporated areas   February 13, 2009;    The Honorable Paul Biane,  June 19, 2009..................       060270
     No: B-1044).                    of San Bernardino      February 20, 2009;    Chairman, San Bernardino
                                     County (08-09-1552P).  San Bernardino        County Board of
                                                            Bulletin.             Supervisors, 385 North
                                                                                Arrowhead Avenue, 5th
                                                                                Floor, San Bernardino,
                                                                                CA 92415.
    San Diego (FEMA Docket No: B-   City of National City  March 3, 2009; March  The Honorable Ron          July 8, 2009...................       060293
     1046).                          (08-09-1802P).         10, 2009; San Diego   Morrison, Mayor,
                                                            Union-Tribune.        National City, 1243
                                                                                National City Boulevard,
                                                                                National City, CA 91950.
    Shasta (FEMA Docket No: B-      City of Redding (08-   March 9, 2009; March  The Honorable Rick         March 30, 2009.................       060360
     1052).                          09-0964P).             16, 2009; Record      Bosetti, Mayor, City of
                                                            Searchlight.          Redding, P.O. Box
                                                                                496071, Redding, CA
                                                                                96001.
Colorado:
    Jefferson (FEMA Docket No: B-   City of Golden (09-08- March 5, 2009; March  The Honorable Jacob        February 27, 2009..............       080090
     1046).                          0184P).                12, 2009; Golden      Smith, Mayor, City of
                                                            Transcript.           Golden, 911 10th Street,
                                                                                Golden, CO 80401.
    Teller (FEMA Docket No: B-      Unincorporated areas   March 11, 2009;       The Honorable James        July 16, 2009..................       080173
     1048).                          of Teller County (08-  March 18, 2009;       Ignatius, Chairman,
                                     08-0921P).             Pikes Peak Courier    Teller County Board of
                                                            View.                 Commissioners, 112 North
                                                                                A Street, Cripple Creek,
                                                                                CO 80813.
    Teller (FEMA Docket No: B-      Town of Woodland Park  March 11, 2009;       The Honorable Steve        July 16, 2009..................       080175
     1048).                          (08-08-0921P).         March 18, 2009;       Randolph, Mayor, City of
                                                            Pikes Peak Courier    Woodland Park, 220 West
                                                            View.                 South Avenue, Woodland
                                                                                Park, CO 80866.
    Weld (FEMA Docket No: B-1052).  Town of Severance (08- February 20, 2009;    The Honorable Pierre De    June 29, 2009..................       080317
                                     08-0702X).             February 27, 2009;    Milt, Mayor, Town of
                                                            Greeley Tribune.      Severance, 231 West 4th
                                                                                Avenue, Severance, CO
                                                                                80546.
    Weld (FEMA Docket No: B-1052).  Unincorporated areas   February 20, 2009;    The Honorable David E.     June 29, 2009..................       080266
                                     of Weld County (08-    February 27, 2009;    Long, Chairman, Weld
                                     08-0702X).             Greeley Tribune.      County Board of
                                                                                Commissioners, P.O. Box
                                                                                758, Greeley, CO 80632.
Florida: Seminole (FEMA Docket No:  Unincorporated areas   March 6, 2009; March  The Honorable Bob          February 25, 2009..............       120289
 B-1046).                            of Seminole County     13, 2009; Orlando     Dallari, Chairman,
                                     (08-04-6702P).         Sentinel.             Seminole County Board of
                                                                                Commissioners, 1101 East
                                                                                1st Street, Sanford, FL
                                                                                32771.

Georgia: Columbia (FEMA Docket No:  Unincorporated areas   March 1, 2009; March  The Honorable Ron C.       July 6, 2009...................       130059
 B-1046).                            of Columbia County     8, 2009; Columbia     Cross, Chairman,
                                     (07-04-4253P).         County News Times.    Columbia County Board of
                                                                                Commissioners, P.O. Box
                                                                                498, Evans, GA 30809.
Idaho:
    Ada (FEMA Docket No: B-1042)..  Unincorporated areas   February 6, 2009;     The Honorable Fred         June 15, 2009..................       160001
                                     of Ada County (08-10-  February 13, 2009;    Tilman, Chairman, Ada
                                     0658P).                Idaho Statesman.      County Board of
                                                                                Commissioners, 200 West
                                                                                Front Street, Boise, ID
                                                                                83702.
    Ada (FEMA Docket No: B-1042)..  City of Meridian (08-  February 6, 2009;     The Honorable Tammy de     June 15, 2009..................       160180
                                     10-0658P).             February 13, 2009;    Weerd, Mayor, City of
                                                            Idaho Statesman.      Meridian, Meridian City
                                                                                Hall, Suite 300, 33 East
                                                                                Broadway Avenue,
                                                                                Meridian, ID 83702.
    Blaine (FEMA Docket No: B-      Unincorporated areas   March 11, 2009;       The Honorable Tom Bowman,  February 27, 2009..............       165167
     1046).                          of Blaine County (09-  March 18, 2009;       Chairman, Blaine County
                                     10-0141P).             Idaho Mountain        Board of Commissioners,
                                                            Express.              206 First Avenue South,
                                                                                Suite 300, Hailey, ID
                                                                                83333.
    Blaine (FEMA Docket No: B-      City of Hailey (09-10- March 11, 2009;       The Honorable Rick Davis,  February 27, 2009..............       160022
     1046).                          0141P).                March 18, 2009;       Mayor, City of Hailey,
                                                            Idaho Mountain        115 Main Street South,
                                                            Express.              Suite H, Hailey, ID
                                                                                83333.
Indiana: Hamilton (FEMA Docket No:  City of Carmel (08-05- February 26, 2009;    The Honorable James        July 6, 2009...................       180081
 B-1044).                            5476P).                March 5, 2009;        Brainard, Mayor, City of
                                                            Noblesville Ledger.   Carmel, One Civic
                                                                                Square, Carmel, IN 46032.
Iowa: Dubuque (FEMA Docket No: B-   Unincorporated areas   February 6, 2009;     The Honorable Donna        June 15, 2009..................       190534
 1042).                              of Dubuque County      February 13, 2009;    Smith, Supervisor,
                                     (08-07-0804P).         Telegraph Herald.     Dubuque County Board of
                                                                                Supervisors, 720 Central
                                                                                Avenue, Dubuque, IA
                                                                                52001.
Louisiana:
    East Baton Rouge (FEMA Docket   Unincorporated areas   February 11, 2009;    The Honorable Melvin       June 18, 2009..................       220058
     No: B-1046).                    of East Baton Rouge    February 18, 2009;    Holden, Mayor, East
                                     Parish (08-06-2569P).  The Advocate.         Baton Rouge Parish, 222
                                                                                Saint Louis Street, 3rd
                                                                                Floor, Baton Rouge, LA
                                                                                70802.
    East Baton Rouge (FEMA Docket   City of Zachary (08-   February 12, 2009;    The Honorable Henry J.     June 18, 2009..................       220061
     No: B-1046).                    06-2569P).             February 19, 2009;    Martinez, Mayor, City of
                                                            Zachary Plainsman.    Zachary, 4700 Main
                                                                                Street, Zachary, LA
                                                                                70791.
Maine: Cumberland (FEMA Docket No:  Town of Falmouth (09-  February 6, 2009;     The Honorable William      June 15, 2009..................       230045
 B-1042).                            01-0124P).             February 13, 2009;    Armitage, Chair,
                                                            Portland Press        Falmouth Town Council,
                                                            Herald.               271 Falmouth Road,
                                                                                Falmouth, ME 04105.
Missouri: Clay, Platte, and         City of Kansas City    February 12, 2009;    The Honorable Mark W.      June 19, 2009..................       290173
 Jackson (FEMA Docket No: B-1042).   (08-07-0725P).         February 19, 2009;    Funkhouser, Mayor, City
                                                            The Daily Record.     of Kansas City, City
                                                                                Hall, 29th Floor, 414
                                                                                East 12th Street, Kansas
                                                                                City, MO 64106.
Nevada: Clark (FEMA Docket No: B-   Unincorporated areas   February 20, 2009;    The Honorable Rory Reid,   June 29, 2009..................       320003
 1044).                              of Clark County (09-   February 27, 2009;    Chair, Clark County
                                     09-0318P).             Las Vegas Review-     Board of Commissioners,
                                                            Journal.              500 South Grand Central
                                                                                Parkway, Las Vegas, NV
                                                                                89106.
New Mexico: Sandoval (FEMA Docket   City of Rio Rancho     February 6, 2009;     The Honorable Thomas E.    June 15, 2009..................       350146
 No: B-1042).                        (08-06-3060P).         February 13, 2009;    Swisstack, Mayor, City
                                                            The Albuquerque       of Rio Rancho, 3200
                                                            Journal.              Civic Center Circle
                                                                                Northeast, Rio Rancho,
                                                                                NM 87144.
Montana: Stillwater (FEMA Docket    Unincorporated areas   July 17, 2008; July   The Honorable Dennis R.    November 24, 2008..............       300078
 No: B-1055).                        of Stillwater County   24, 2008;             Hoyem, Chairman,
                                     (07-08-0854P).         Stillwater County     Stillwater County Board
                                                            News.                 of Commissioners, P.O.
                                                                                Box 970, Columbus, MT
                                                                                59019.
North Carolina: Guilford (FEMA      City of Greensboro     March 6, 2009; March  The Honorable Yvonne J.    July 13, 2009..................       375351
 Docket No: B-1046).                 (09-04-0087P).         13, 2009;             Johnson, Mayor, City of
                                                            Greensboro News &     Greensboro, P.O. Box
                                                            Record.               3136, Greensboro, NC
                                                                                27402.
Ohio: Lorain (FEMA Docket No: B-    City of Avon Lake (08- March 12, 2009;       The Honorable Karl J.      February 27, 2009..............       390602
 1048).                              05-5004P).             March 19, 2009;       Zuber, Mayor, City of
                                                            Morning Journal.      Avon Lake, 150 Avon
                                                                                Belden Road, Avon Lake,
                                                                                OH 44012.
South Carolina: Jasper (FEMA        Unincorporated areas   March 4, 2009; March  The Honorable Dr. George   July 9, 2009...................       450112
 Docket No: B-1046).                 of Jasper County (08-  11, 2009; Jasper      Hood, Chairman, Jasper
                                     04-5295P).             County Sun.           County Council, P.O. Box
                                                                                1149, Ridgeland, SC
                                                                                29936.
Tennessee: Nashville and Davidson   Metropolitan           February 6, 2009;     The Honorable Karl Dean,   June 16, 2009..................       470040
 (FEMA Docket No: B-1044).           Government of          February 13, 2009;    Mayor, Metropolitan
                                     Nashville and          The Tennessean.       Government of Nashville
                                     Davidson County (08-                         and Davidson County, 100
                                     04-5048P).                                   Metro Courthouse,
                                                                                Nashville, TN 37201.
Texas:
    Bexar (FEMA Docket No: B-1046)  Unincorporated areas   March 6, 2009; March  The Honorable Nelson W.    July 13, 2009..................       480035
                                     of Bexar County (09-   13, 2009; Daily       Wolff, Bexar County
                                     06-0762P).             Commercial Recorder.  Judge, 100 Dolorosa
                                                                                Street, Suite 120, San
                                                                                Antonio, TX 78205.
    Brazos (FEMA Docket No: B-      City of Bryan (08-06-  February 12, 2009;    The Honorable Mark         June 19, 2009..................       480082
     1042).                          2045P).                February 19, 2009;    Conlee, Mayor, City of
                                                            Bryan-College         Bryan, 300 South Texas
                                                            Station Eagle.        Avenue, Bryan, TX 77803.
    Collin (FEMA Docket No: B-      City of Frisco (09-06- February 6, 2009;     The Honorable Maher Maso,  June 15, 2009..................       480134
     1042).                          0212P).                February 13, 2009;    Mayor, City of Frisco,
                                                            Frisco Enterprise.    6101 Frisco Square
                                                                                Boulevard, Frisco, TX
                                                                                75034.

    Denton (FEMA Docket No: B-      Town of Copper Canyon  March 2, 2009; March  The Honorable Sue Tejml,   February 25, 2009..............       481508
     1046).                          (09-06-0214P).         9, 2009; Denton       Mayor, Town of Copper
                                                            Record-Chronicle.     Canyon, 400 Woodland
                                                                                Drive, Copper Canyon, TX
                                                                                75077.
    Guadalupe (FEMA Docket No: B-   City of Cibolo (08-06- February 12, 2009;    The Honorable Johnny       June 18, 2009..................       480267
     1042).                          2221P).                February 19, 2009;    Sutton, Mayor, City of
                                                            Seguin Gazette-       Cibolo, P.O. Box 826,
                                                            Enterprise.           Cibolo, TX 78108.
    Guadalupe (FEMA Docket No: B-   Unincorporated areas   February 12, 2009;    The Honorable Mike         June 18, 2009..................       480266
     1042).                          of Guadalupe County    February 19, 2009;    Wiggins, Guadalupe
                                     (08-06-2221P).         Seguin Gazette-       County Judge, 307 West
                                                            Enterprise.           Court Street, Seguin, TX
                                                                                78155.
    Tarrant (FEMA Docket No: B-     City of Fort Worth     March 3, 2009; March  The Honorable Michael J.   February 23, 2009..............       480596
     1052).                          (09-06-0411P).         10, 2009; Fort        Moncrief, Mayor, City of
                                                            Worth Star-Telegram.  Fort Worth, 1000
                                                                                Throckmorton Street,
                                                                                Fort Worth, TX 76102.
    Tarrant (FEMA Docket No: B-     City of Southlake (09- March 3, 2009; March  The Honorable Andy         February 20, 2009..............       480612
     1052).                          06-0528P).             10, 2009; Fort        Wambsganss, Mayor, City
                                                            Worth Star-Telegram.  of Southlake, 1400 Main
                                                                                Street, Suite 270,
                                                                                Southlake, TX 76092.
    Webb (FEMA Docket No: B-1044).  City of Laredo (08-06- February 6, 2009;     The Honorable Raul G.      June 15, 2009..................       480651
                                     2454P).                February 13, 2009;    Salinas, Mayor, City of
                                                            Laredo Morning        Laredo, 1110 Houston
                                                            Times.                Street, Laredo, TX 78040.
    Webb (FEMA Docket No: B-1044).  Unincorporated areas   February 6, 2009;     The Honorable Danny        June 15, 2009..................       481059
                                     of Webb County (08-    February 13, 2009;    Valdez, Webb County
                                     06-2740P).             Laredo Morning        Judge, Webb County
                                                            Times.                Courthouse, 1000 Houston
                                                                                Street, 3rd Floor,
                                                                                Laredo, TX 78040.
Utah:
    Salt Lake (FEMA Docket No: B-   City of Riverton (08-  February 12, 2009;    The Honorable Bill         June 19, 2009..................       490104
     1044).                          08-0716P).             February 19, 2009;    Applegarth, Mayor, City
                                                            Salt Lake Tribune.    of Riverton, 12765 South
                                                                                1400 West, Riverton, UT
                                                                                84065.
    Salt Lake (FEMA Docket No: B-   City of South Jordan   February 12, 2009;    The Honorable William      June 19, 2009..................       490107
     1044).                          (08-08-0716P).         February 19, 2009;    Kent Money, Mayor, City
                                                            Salt Lake Tribune.    of South Jordan, 1600
                                                                                West Towne Center Drive,
                                                                                South Jordan, UT 84095.
Virginia: Fauquier (FEMA Docket     Unincorporated areas   March 5, 2009; March  The Honorable R. Holder    July 10, 2009..................       510055
 No: B-1046).                        of Fauquier County     12, 2009; Fauquier    Trumbo, Jr., Chairman,
                                     (08-03-1792P).         Times-Democrat.       Board of Supervisors, 10
                                                                                Hotel Street, Suite 208,
                                                                                Warrenton, VA 20186.
Wisconsin:
    Dane (FEMA Docket No: B-1046).  City of Sun Prairie    March 12, 2009;       The Honorable Joe Chase,   February 27, 2009..............       550573
                                     (08-05-1760P).         March 19, 2009; The   Mayor, City of Sun
                                                            Star.                 Prairie, 300 East Main
                                                                                Street, Sun Prairie, WI
                                                                                53590.
    Waukesha (FEMA Docket No: B-    Unincorporated areas   February 12, 2009;    The Honorable James T.     June 19, 2009..................       550476
     1044).                          of Waukesha County     February 19, 2009;    Dwyer, Chairman,
                                     (08-05-4338P).         Waukesha Freeman.     Waukesha County Board of
                                                                                Supervisors, 515 West
                                                                                Moreland Boulevard,
                                                                                Waukesha, WI 53188.
--------------------------------------------------------------------------------------------------------------------------------------------------------

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

    Dated: March 18, 2010.
Edward L. Connor,
Acting Federal Insurance and Mitigation Administrator, Mitigation,
Department of Homeland Security, Federal Emergency Management Agency.
[FR Doc. 2010-8085 Filed 4-8-10; 8:45 am]
BILLING CODE 9110-12-P


Sec.  507.49  Verification of implementation and effectiveness.

    (a) You must verify that the preventive controls are consistently
implemented and are effectively and significantly minimizing or
preventing the hazards. To do so, you must conduct activities that
include the following, as appropriate to the facility, the animal food,
and the nature of the preventive control and its role in the facility's
food safety system:
    (1) Calibration of process monitoring and verification instruments
(or checking them for accuracy);
    (2) Product testing for a pathogen (or appropriate indicator
organism) or other hazard;
    (3) Environmental monitoring, for an environmental pathogen or for
an appropriate indicator organism, if contamination of an animal food
with an environmental pathogen is a hazard requiring a preventive
control, by collecting and testing environmental samples; and
    (4) Review of the following records within the specified
timeframes, by (or under the oversight of) a preventive controls
qualified individual, to ensure the records are complete, the
activities reflected in the records occurred in accordance with the
food safety plan, the preventive controls are effective, and
appropriate decisions were made about corrective actions:
    (i) Monitoring and corrective action records within 7-working days
after the records are created or within a reasonable timeframe,
provided that the preventive controls qualified individual prepares (or
oversees the preparation of) a written justification for a timeframe
that exceeds 7-working days; and
    (ii) Records of calibration, testing (e.g., product testing,
environmental monitoring), and supplier and supply-chain verification
activities, and other verification activities within a reasonable time
after the records are created; and
    (5) Other activities appropriate for verification of implementation
and effectiveness.
    (b) As appropriate to the facility, the food, the nature of the
preventive control, and the role of the preventive control in the
facility's food safety system, you must establish and implement written
procedures for the following activities:
    (1) The method and frequency of calibrating process monitoring
instruments and verification instruments (or checking them for
accuracy) as required by paragraph (a)(1) of this section;
    (2) Product testing as required by paragraph (a)(2) of this
section. Procedures for product testing must:
    (i) Be scientifically valid;
    (ii) Identify the test microorganism(s) or other analyte(s);
    (iii) Specify the procedures for identifying samples, including
their relationship to specific lots of product;
    (iv) Include the procedures for sampling, including the number of
samples and the sampling frequency;
    (v) Identify the test(s) conducted, including the analytical
method(s) used;
    (vi) Identify the laboratory conducting the testing; and
    (vii) Include the corrective action procedures required by Sec.
507.42(a)(1).
    (3) Environmental monitoring as required by paragraph (a)(3) of
this section. Procedures for environmental monitoring must:
    (i) Be scientifically valid;
    (ii) Identify the test microorganism(s);
    (iii) Identify the locations from which samples will be collected
and the number of sites to be tested during routine environmental
monitoring. The number and location of sampling sites must be adequate
to determine whether preventive controls are effective;
    (iv) Identify the timing and frequency for collecting and testing
samples. The timing and frequency for collecting and testing samples
must be adequate to determine whether preventive controls are
effective;
    (v) Identify the test(s) conducted, including the analytical
method(s) used;
    (vi) Identify the laboratory conducting the testing; and
    (vii) Include the corrective action procedures required by Sec.
507.42(a)(1)(ii).

Sec.  507.50  Reanalysis.

    (a) You must conduct a reanalysis of the food safety plan as a
whole at least once every 3 years.
    (b) You must conduct a reanalysis of the food safety plan as a
whole, or the applicable portion of the food safety plan:
    (1) Whenever a significant change in the activities conducted at
your facility creates a reasonable potential for a new hazard or
creates a significant increase in a previously identified hazard;
    (2) Whenever you become aware of new information about potential
hazards associated with the animal food;
    (3) Whenever appropriate after an unanticipated animal food safety
problem in accordance with Sec.  507.42(b); and

    (4) Whenever you find that a preventive control, combination of
preventive controls, or the food safety plan as a whole is ineffective.
    (c) You must complete the reanalysis required by paragraphs (a) and
(b) of this section and validate, as appropriate to the nature of the
preventive control and its role in the facility's food safety system,
any additional preventive controls needed to address the hazard
identified:
    (1) Before any change in activities (including any change in
preventive control) at the facility is operative; or,
    (2) When necessary to demonstrate the control measures can be
implemented as designed:
    (i) Within 90 calendar days after production of the applicable
animal food first begins; or
    (ii) Within a reasonable timeframe, provided that the preventive
controls qualified individual prepares (or oversees the preparation of)
a written justification for a timeframe that exceeds 90 calendar days
after production of the applicable animal food first begins.
    (d) You must revise the written food safety plan if a significant
change in the activities conducted at your facility creates a
reasonable potential for a new hazard or a significant increase in a
previously identified hazard, or document the basis for the conclusion
that no revisions are needed.
    (e) A preventive controls qualified individual must perform (or
oversee) the reanalysis.
    (f) You must conduct a reanalysis of the food safety plan when FDA
determines it is necessary to respond to new hazards and developments
in scientific understanding.

Sec.  507.51  Modified requirements that apply to a facility solely
engaged in the storage of unexposed packaged animal food.

    (a) If a facility that is solely engaged in the storage of
unexposed packaged animal food stores any such refrigerated packaged
animal food that requires time/temperature control to significantly
minimize or prevent the growth of, or toxin formation by pathogens, the
facility must conduct the following activities as appropriate to ensure
the effectiveness of the temperature controls:
    (1) Establish and implement temperature controls adequate to
significantly minimize or prevent the growth of, or toxin formation by,
pathogens;
    (2) Monitor the temperature controls with adequate frequency to
provide assurance that the temperature controls are consistently
performed;
    (3) If there is a loss of temperature control that may impact the
safety of such refrigerated packaged animal food, take appropriate
corrective actions to:
    (i) Correct the problem and reduce the likelihood that the problem
will recur;
    (ii) Evaluate all affected animal food for safety; and
    (iii) Prevent the animal food from entering commerce, if you cannot
ensure the affected animal food is not adulterated under section 402 of
the Federal Food, Drug, and Cosmetic Act;
    (4) Verify that temperature controls are consistently implemented
by:
    (i) Calibrating temperature monitoring and recording devices (or
checking them for accuracy);
    (ii) Reviewing records of calibration within a reasonable time
after the records are created; and
    (iii) Reviewing records of monitoring and corrective actions taken
to correct a problem with the control of temperature within 7-working
days after the records are created or within a reasonable timeframe,
provided that the preventive controls qualified individual prepares (or
oversees the preparation of) a written justification for a timeframe
that exceeds 7-working days;
    (5) Establish and maintain the following records:
    (i) Records (whether affirmative records demonstrating temperature
is controlled or exception records demonstrating loss of temperature
control) documenting the monitoring of temperature controls for any
such refrigerated packaged animal food;
    (ii) Records of corrective actions taken when there is a loss of
temperature control that may impact the safety of any such refrigerated
packaged animal food; and
    (iii) Records documenting the verification activities.
    (b) The records that a facility must establish and maintain under
paragraph (a)(5) of this section are subject to the requirements of
subpart F of this part.

Sec.  507.53  Requirements applicable to a preventive controls
qualified individual and a qualified auditor.

    (a) One or more preventive controls qualified individuals must do
or oversee the following:
    (1) Preparation of the food safety plan (Sec.  507.31(b));
    (2) Validation of the preventive controls (Sec.  507.47(b)(1));
    (3) Written justification for validation to be performed in a
timeframe that exceeds the first 90 calendar days of production of the
applicable animal food;
    (4) Determination that validation is not required (Sec.
507.47(c)(4));
    (5) Review of records (Sec.  507.49(a)(4));
    (6) Written justification for review of records of monitoring and
corrective actions within a timeframe that exceeds 7-working days;
    (7) Reanalysis of the food safety plan (Sec.  507.50(d)); and
    (8) Determination that reanalysis can be completed, and additional
preventive controls validated, as appropriate to the nature of the
preventive control and its role in the facility's food safety system,
in a timeframe that exceeds the first 90 calendar days of production of
the applicable animal food.
    (b) A qualified auditor must conduct an onsite audit (Sec.
507.135(a)).
    (c)(1) To be a preventive controls qualified individual, the
individual must have successfully completed training in the development
and application of risk-based preventive controls at least equivalent
to that received under a standardized curriculum recognized as adequate
by FDA or be otherwise qualified through job experience to develop and
apply a food safety system. Job experience may qualify an individual to
perform these functions if such experience has provided an individual
with knowledge at least equivalent to that provided through the
standardized curriculum. This individual may be, but is not required to
be, an employee of the facility; and
    (2) To be a qualified auditor, a qualified individual must have
technical expertise obtained through education, training, or experience
(or a combination thereof) necessary to perform the auditing function.
    (d) All applicable training in the development and application of
risk-based preventive controls must be documented in records, including
the date of the training, the type of training, and the person(s)
trained.

Sec.  507.55  Implementation records required for this subpart.

    (a) You must establish and maintain the following records
documenting implementation of the food safety plan:
    (1) Documentation, as required by Sec.  507.36(b), of the basis for
not establishing a preventive control in accordance with Sec.
507.36(a);
    (2) Records that document the monitoring of preventive controls;
    (3) Records that document corrective actions;
    (4) Records that document verification, including, as applicable,
those related to:
    (i) Validation;
    (ii) Verification of monitoring;
    (iii) Verification of corrective actions;
    (iv) Calibration of process monitoring and verification
instruments;

    (v) Product testing;
    (vi) Environmental monitoring;
    (vii) Records review; and
    (viii) Reanalysis;
    (5) Records that document the supply-chain program; and
    (6) Records that document applicable training for the preventive
controls qualified individual and the qualified auditor.
    (b) The records that you must establish and maintain are subject to
the requirements of subpart F of this part.

Subpart D--Withdrawal of a Qualified Facility Exemption

Sec.  507.60  Circumstances that may lead FDA to withdraw a qualified
facility exemption.

    (a) FDA may withdraw a qualified facility exemption under Sec.
507.5(d):
    (1) In the event of an active investigation of a foodborne illness
outbreak that is directly linked to the qualified facility; or
    (2) If FDA determines that it is necessary to protect the public
(human or animal) health and prevent or mitigate a foodborne illness
outbreak based on conditions or conduct associated with the qualified
facility that are material to the safety of the animal food
manufactured, processed, packed, or held at such facility.
    (b) Before FDA issues an order to withdraw a qualified facility
exemption, FDA:
    (1) May consider one or more other actions to protect the public
(human or animal) health or mitigate a foodborne illness outbreak,
including, a warning letter, recall, administrative detention,
suspension of registration, refusal of animal food offered for import,
seizure, and injunction;
    (2) Must notify the owner, operator, or agent in charge of the
facility, in writing of circumstances that may lead FDA to withdraw the
exemption, and provide an opportunity for the owner, operator, or agent
in charge of the facility to respond in writing, within 15 calendar
days of the date of receipt of the notification, to FDA's notification;
and
    (3) Must consider the actions taken by the facility to address the
circumstances that may lead FDA to withdraw the exemption.

Sec.  507.62  Issuance of an order to withdraw a qualified facility
exemption.

    (a) An FDA District Director in whose district the qualified
facility is located (or, in the case of a foreign facility, the
Director of the Division of Compliance in the Center for Veterinary
Medicine), or an FDA official senior to either such Director, must
approve an order to withdraw the exemption before the order is issued.
    (b) Any officer or qualified employee of FDA may issue an order to
withdraw the exemption after it has been approved in accordance with
paragraph (a) of this section.
    (c) FDA must issue an order to withdraw the exemption to the owner,
operator, or agent in charge of the facility.
    (d) FDA must issue an order to withdraw the exemption in writing,
signed and dated by the officer or qualified employee of FDA who is
issuing the order.

Sec.  507.65  Contents of an order to withdraw a qualified facility
exemption.

    An order to withdraw a qualified facility exemption under Sec.
507.5(d) must include the following information:
    (a) The date of the order;
    (b) The name, address, and location of the qualified facility;
    (c) A brief, general statement of the reasons for the order,
including information relevant to one or both of the following
circumstances that leads FDA to issue the order:
    (1) An active investigation of a foodborne illness outbreak that is
directly linked to the facility; or
    (2) Conditions or conduct associated with a qualified facility that
are material to the safety of the animal food manufactured, processed,
packed, or held at such facility.
    (d) A statement that the facility must either:
    (1) Comply with subparts C and E of this part on the date that is
120 calendar days after the date of receipt of the order or within a
reasonable timeframe, agreed to by FDA, based on a written
justification, submitted to FDA, for a timeframe that exceeds 120
calendar days from the date of receipt of the order; or
    (2) Appeal the order within 15 calendar days of the date of receipt
of the order in accordance with the requirements of Sec.  507.69.
    (e) A statement that a facility may request that FDA reinstate an
exemption that was withdrawn by following the procedures in Sec.
507.85.
    (f) The text of section 418(l) of the Federal Food, Drug, and
Cosmetic Act and of this subpart;
    (g) A statement that any informal hearing on an appeal of the order
must be conducted as a regulatory hearing under part 16 of this
chapter, with certain exceptions described in Sec.  507.73;
    (h) The mailing address, telephone number, email address, and
facsimile number of the FDA district office and the name of the FDA
District Director in whose district the facility is located (or, in the
case of a foreign facility, the same information for the Director of
the Division of Compliance in the Center for Veterinary Medicine); and
    (i) The name and the title of the FDA representative who approved
the order.

Sec.  507.67  Compliance with, or appeal of, an order to withdraw a
qualified facility exemption.

    (a) If you receive an order under Sec.  507.65 to withdraw a
qualified facility exemption, you must either:
    (1) Comply with applicable requirements of this part within 120
calendar days of the date of receipt of the order, or within a
reasonable timeframe, agreed to by FDA, based on a written
justification, submitted to FDA, for a timeframe that exceeds 120
calendar days from the date of receipt of the order; or
    (2) Appeal the order within 15 calendar days of the date of receipt
of the order in accordance with the requirements of Sec.  507.69.
    (b) Submission of an appeal, including submission of a request for
an informal hearing, will not operate to delay or stay any
administrative action, including enforcement action by FDA, unless the
Commissioner of Food and Drugs, as a matter of discretion, determines
that delay or a stay is in the public interest.
    (c) If you appeal the order, and FDA confirms the order:
    (1) You must comply with applicable requirements of this part
within 120 calendar days of the date of receipt of the order, or within
a reasonable timeframe, agreed to by FDA, based on a written
justification, submitted to FDA, for a timeframe that exceeds 120
calendar days from the date of receipt of the order; and
    (2) You are no longer subject to the requirements in Sec.  507.7.

Sec.  507.69  Procedure for submitting an appeal.

    (a) To appeal an order to withdraw a qualified facility exemption,
you must:
    (1) Submit the appeal in writing to the FDA District Director in
whose district the facility is located (or, in the case of a foreign
facility, the Director of the Division of Compliance in the Center for
Veterinary Medicine), at the mailing address, email address, or
facsimile number identified in the order within 15 calendar days of the
date of receipt of confirmation of the order;
    (2) Respond with particularity to the facts and issues contained in
the order, including any supporting documentation upon which you rely.
    (b) In a written appeal of the order withdrawing an exemption
provided under Sec.  507.5(d), you may include a

written request for an informal hearing as provided in Sec.  507.71.

Sec.  507.71  Procedure for requesting an informal hearing.

    (a) If you appeal the order, you:
    (1) May request an informal hearing; and
    (2) Must submit any request for an informal hearing together with
your written appeal submitted in accordance with Sec.  507.69 within 15
calendar days of the date of receipt of the order.
    (b) A request for an informal hearing may be denied, in whole or in
part, if the presiding officer determines that no genuine and
substantial issue of material fact has been raised by the material
submitted. If the presiding officer determines that a hearing is not
justified, written notice of the determination will be given to you
explaining the reason for the denial.

Sec.  507.73  Requirements applicable to an informal hearing.

    If you request an informal hearing, and FDA grants the request:
    (a) The hearing will be held within 15 calendar days after the date
the appeal is filed or, if applicable, within a timeframe agreed upon
in writing by you and FDA.
    (b) The presiding officer may require that a hearing conducted
under this subpart be completed within 1 calendar day, as appropriate.
    (c) FDA must conduct the hearing in accordance with part 16 of this
chapter, except that:
    (1) The order withdrawing an exemption under Sec. Sec.  507.62 and
507.65, rather than the notice under Sec.  16.22(a) of this chapter,
provides notice of opportunity for a hearing under this section and is
part of the administrative record of the regulatory hearing under Sec.
16.80(a) of this chapter.
    (2) A request for a hearing under this subpart must be addressed to
the FDA District Director (or, in the case of a foreign facility, the
Director of the Division of Compliance in the Center for Veterinary
Medicine) as provided in the order withdrawing an exemption.
    (3) Section 507.75, rather than Sec.  16.42(a) of this chapter,
describes the FDA employees who preside at hearings under this subpart.
    (4) Section 16.60(e) and (f) of this chapter does not apply to a
hearing under this subpart. The presiding officer must prepare a
written report of the hearing. All written material presented at the
hearing will be attached to the report. The presiding officer must
include as part of the report of the hearing a finding on the
credibility of witnesses (other than expert witnesses) whenever
credibility is a material issue, and must include a proposed decision,
with a statement of reasons. The hearing participant may review and
comment on the presiding officer's report within 2 calendar days of
issuance of the report. The presiding officer will then issue the final
decision.
    (5) Section 16.80(a)(4) of this chapter does not apply to a
regulatory hearing under this subpart. The presiding officer's report
of the hearing and any comments on the report by the hearing
participant under paragraph (c)(4) of this section are part of the
administrative record.
    (6) No party shall have the right, under Sec.  16.119 of this
chapter to petition the Commissioner of Food and Drugs for
reconsideration or a stay of the presiding officer's final decision.
    (7) If FDA grants a request for an informal hearing on an appeal of
an order withdrawing an exemption, the hearing must be conducted as a
regulatory hearing under a regulation in accordance with part 16 of
this chapter, except that Sec.  16.95(b) does not apply to a hearing
under this subpart. With respect to a regulatory hearing under this
subpart, the administrative record of the hearing specified in
Sec. Sec.  16.80(a)(1) through (3), and (a)(5), of this chapter, and
507.73(c)(5) constitutes the exclusive record for the presiding
officer's final decision. For purposes of judicial review under Sec.
10.45 of this chapter, the record of the administrative proceeding
consists of the record of the hearing and the presiding officer's final
decision.

Sec.  507.75  Presiding officer for an appeal and for an informal
hearing.

    The presiding officer for an appeal, and for an informal hearing,
must be an FDA Regional Food and Drug Director or another FDA official
senior to an FDA District Director.

Sec.  507.77  Timeframe for issuing a decision on an appeal.

    (a) If you appeal the order without requesting a hearing, the
presiding officer must issue a written report that includes a final
decision confirming or revoking the withdrawal by the 10th calendar day
after the appeal is filed.
    (b) If you appeal the order and request an informal hearing:
    (1) If FDA grants the request for a hearing and the hearing is
held, the presiding officer must provide a 2 calendar day opportunity
for the hearing participants to review and submit comments on the
report of the hearing under Sec.  507.73(c)(4), and must issue a final
decision within 10 calendar days after the hearing is held; or
    (2) If FDA denies the request for a hearing, the presiding officer
must issue a final decision on the appeal confirming or revoking the
withdrawal within 10 calendar days after the date the appeal is filed.

Sec.  507.80  Revocation of an order to withdraw a qualified facility
exemption.

    An order to withdraw a qualified facility exemption is revoked if:
    (a) You appeal the order and request an informal hearing, FDA
grants the request for an informal hearing, and the presiding officer
does not confirm the order within the 10 calendar days after the
hearing, or issues a decision revoking the order within that time; or
    (b) You appeal the order and request an informal hearing, FDA
denies the request for an informal hearing, and FDA does not confirm
the order within the 10 calendar days after the appeal is filed, or
issues a decision revoking the order within that time; or
    (c) You appeal the order without requesting an informal hearing,
and FDA does not confirm the order within the 10 calendar days after
the appeal is filed, or issues a decision revoking the order within
that time.

Sec.  507.83  Final agency action.

    Confirmation of a withdrawal order by the presiding officer is
considered a final agency action for purposes of 5 U.S.C. 702.

Sec.  507.85  Reinstatement of a qualified facility exemption that was
withdrawn.

    (a) If the FDA District Director in whose district your facility is
located (or, in the case of a foreign facility, the Director of the
Division of Compliance in the Center for Veterinary Medicine)
determines that a facility has adequately resolved any problems with
the conditions and conduct that are material to the safety of the
animal food manufactured, processed, packed, or held at the facility
and that continued withdrawal of the exemption is not necessary to
protect public (human and animal) health and prevent or mitigate a
foodborne illness outbreak, the FDA District Director in whose district
your facility is located (or, in the case of a foreign facility, the
Director of the Division of Compliance in the Center for Veterinary
Medicine) will, on his own initiative or on the request of a facility,
reinstate the exemption.
    (b) You may ask FDA to reinstate an exemption that has been
withdrawn under the procedures of this subpart as follows:
    (1) Submit a request, in writing, to the FDA District Director in
whose district your facility is located (or, in the case

of a foreign facility, the Director of the Division of Compliance in
the Center for Veterinary Medicine); and
    (2) Present data and information to demonstrate that you have
adequately resolved any problems with the conditions and conduct that
are material to the safety of the animal food manufactured, processed,
packed, or held at your facility, such that continued withdrawal of the
exemption is not necessary to protect public (human and animal) health
and prevent or mitigate a foodborne illness outbreak.
    (c) If your exemption was withdrawn under Sec.  507.60(a)(1) and
FDA later determines, after finishing the active investigation of a
foodborne illness outbreak, that the outbreak is not directly linked to
your facility, FDA will reinstate your exemption under Sec.  507.5(d),
and FDA will notify you in writing that your exempt status has been
reinstated.
    (d) If your exemption was withdrawn under both Sec.  507.60(a)(1)
and (2) and FDA later determines, after finishing the active
investigation of a foodborne illness outbreak, that the outbreak is not
directly linked to your facility, FDA will inform you of this finding
and you may ask FDA to reinstate your exemption under Sec.  507.5(d) in
accordance with the requirements of paragraph (b) of this section.

Subpart E--Supply-Chain Program

Sec.  507.105  Requirement to establish and implement a supply-chain
program.

    (a)(1) Except as provided by paragraphs (a)(2) and (3) of this
section, the receiving facility must establish and implement a risk-
based supply-chain program for those raw materials and other
ingredients for which the receiving facility has identified a hazard
requiring a supply-chain-applied control.
    (2) A receiving facility that is an importer, is in compliance with
the foreign supplier verification requirements under part 1, subpart L
of this chapter, and has documentation of verification activities
conducted under Sec.  1.506(e) of this chapter (which provides
assurance that the hazards requiring a supply-chain-applied control for
the raw material or other ingredient have been significantly minimized
or prevented) need not conduct supplier verification activities for
that raw material or other ingredient.
    (3) The requirements in this subpart do not apply to animal food
that is supplied for research or evaluation use, provided that such
animal food:
    (i) Is not intended for retail sale and is not sold or distributed
to the public;
    (ii) Is labeled with the statement ``Animal food for research or
evaluation use'';
    (iii) Is supplied in a small quantity that is consistent with a
research, analysis, or quality assurance purpose, the animal food is
used only for this purpose, and any unused quantity is properly
disposed of; and
    (iv) Is accompanied with documents, in accordance with the practice
of the trade, stating that the animal food will be used for research or
evaluation purposes and cannot be sold or distributed to the public.
    (b) The supply-chain program must be written.
    (c) When a supply-chain-applied control is applied by an entity
other than the receiving facility's supplier (e.g., when a non-supplier
applies controls to certain produce (i.e., produce covered by part 112
of this chapter), because growing, harvesting, and packing activities
are under different management), the receiving facility must:
    (1) Verify the supply-chain-applied control; or
    (2) Obtain documentation of an appropriate verification activity
from another entity, review and assess the entity's applicable
documentation, and document that review and assessment.

Sec.  507.110  General requirements applicable to a supply-chain
program.

    (a) The supply-chain program must include:
    (1) Using approved suppliers as required by Sec.  507.120;
    (2) Determining appropriate supplier verification activities
(including determining the frequency of conducting the activity) as
required by Sec.  507.125;
    (3) Conducting supplier verification activities as required by
Sec. Sec.  507.130 and 507.135;
    (4) Documenting supplier verification activities as required by
Sec.  507.175; and
    (5) When applicable, verifying a supply-chain-applied control
applied by an entity other than the receiving facility's supplier and
documenting that verification as required by Sec.  507.175, or
obtaining documentation of an appropriate verification activity from
another entity, reviewing and assessing that documentation, and
documenting the review and assessment as required by Sec.  507.175.
    (b) The following are appropriate supplier verification activities
for raw materials and other ingredients:
    (1) Onsite audits;
    (2) Sampling and testing of the raw material or other ingredient;
    (3) Review of the supplier's relevant food safety records; and
    (4) Other appropriate supplier verification activities based on
supplier performance and the risk associated with the raw material or
other ingredient.
    (c) The supply-chain program must provide assurance that a hazard
requiring a supply-chain-applied control has been significantly
minimized or prevented.
    (d)(1) Except as provided by paragraph (d)(2) of this section, in
approving suppliers and determining the appropriate supplier
verification activities and the frequency with which they are
conducted, the following must be considered:
    (i) The hazard analysis of the animal food, including the nature of
the hazard controlled before receipt of the raw material or other
ingredient, applicable to the raw material and other ingredients;
    (ii) The entity or entities that will be applying controls for the
hazards requiring a supply-chain-applied control;
    (iii) Supplier performance, including:
    (A) The supplier's procedures, processes, and practices related to
the safety of the raw material and other ingredients;
    (B) Applicable FDA food safety regulations and information relevant
to the supplier's compliance with those regulations, including an FDA
warning letter or import alert relating to the safety of animal food
and other FDA compliance actions related to animal food safety (or,
when applicable, relevant laws and regulations of a country whose food
safety system FDA has officially recognized as comparable or has
determined to be equivalent to that of the United States, and
information relevant to the supplier's compliance with those laws and
regulations); and
    (C) The supplier's food safety history relevant to the raw
materials or other ingredients that the receiving facility receives
from the supplier, including available information about results from
testing raw materials or other ingredients for hazards, audit results
relating to the safety of the animal food, and responsiveness of the
supplier in correcting problems; and
    (iv) Any other factors as appropriate and necessary, such as
storage and transportation practices.
    (2) Considering supplier performance can be limited to the
supplier's compliance history as required by paragraph (d)(1)(iii)(B)
of this section, if the supplier is:
    (i) A qualified facility as defined by Sec.  507.3;

    (ii) A farm that grows produce and is not a covered farm under part
112 of this chapter in accordance with Sec.  112.4(a), or in accordance
with Sec. Sec.  112.4(b) and 112.5; or
    (iii) A shell egg producer that is not subject to the requirements
of part 118 of this chapter because it has less than 3,000 laying hens.
    (e) If the owner, operator, or agent in charge of a receiving
facility determines through auditing, verification testing, document
review, relevant consumer, customer, or other complaints, or otherwise
that the supplier is not controlling hazards that the receiving
facility has identified as requiring a supply-chain-applied control,
the receiving facility must take and document prompt action in
accordance with Sec.  507.42 to ensure that raw materials or other
ingredients from the supplier do not cause animal food that is
manufactured or processed by the receiving facility to be adulterated
under section 402 of the Federal Food, Drug, and Cosmetic Act.

Sec.  507.115  Responsibilities of the receiving facility.

    (a)(1) The receiving facility must approve suppliers.
    (2) Except as provided by paragraphs (a)(3) and (4) of this
section, the receiving facility must determine and conduct appropriate
supplier verification activities, and satisfy all documentation
requirements of this subpart.
    (3) An entity other than the receiving facility may do any of the
following, provided that the receiving facility reviews and assesses
the entity's applicable documentation, and documents that review and
assessment:
    (i) Establish written procedures for receiving raw materials and
other ingredients by the entity;
    (ii) Document that written procedures for receiving raw materials
and other ingredients are being followed by the entity; and
    (iii) Determine, conduct, or both determine and conduct, the
appropriate supplier verification activities, with appropriate
documentation.
    (4) The supplier may conduct and document sampling and testing of
raw materials and other ingredients, for the hazard controlled by the
supplier, as a supplier verification activity for a particular lot of
product and provide such documentation to the receiving facility,
provided that the receiving facility reviews and assesses that
documentation, and documents that review and assessment.
    (b) For the purposes of this subpart, a receiving facility may not
accept any of the following as a supplier verification activity:
    (1) A determination by its supplier of the appropriate supplier
verification activities for that supplier;
    (2) An audit conducted by its supplier;
    (3) A review by its supplier of that supplier's own relevant food
safety records; or
    (4) The conduct by its supplier of other appropriate supplier
verification activities for that supplier within the meaning of Sec.
507.110(b)(4).
    (c) The requirements of this section do not prohibit a receiving
facility from relying on an audit provided by its supplier when the
audit of the supplier was conducted by a third-party qualified auditor
in accordance with Sec. Sec.  507.130(f) and 507.135.

Sec.  507.120  Using approved suppliers.

    (a) The receiving facility must approve suppliers in accordance
with the requirements of Sec.  507.110(d), and document that approval,
before receiving raw materials and other ingredients received from
those suppliers;
    (b)(1) Written procedures for receiving raw materials and other
ingredients must be established and followed;
    (2) The written procedures for receiving raw materials and other
ingredients must ensure that raw materials and other ingredients are
received only from approved suppliers (or, when necessary and
appropriate, on a temporary basis from unapproved suppliers whose raw
materials or other ingredients are subjected to adequate verification
activities before acceptance for use); and
    (3) Use of the written procedures for receiving raw materials and
other ingredients must be documented.

Sec.  507.125  Determining appropriate supplier verification activities
(including determining the frequency of conducting the activity).

    Appropriate supplier verification activities (including the
frequency of conducting the activity) must be determined in accordance
with the requirements of Sec.  507.110(d).

Sec.  507.130  Conducting supplier verification activities for raw
materials and other ingredients.

    (a) Except as provided by paragraphs (c), (d), or (e) of this
section, one or more of the supplier verification activities specified
in Sec.  507.110(b), as determined under Sec.  507.110(d), must be
conducted for each supplier before using the raw material or other
ingredient from that supplier and periodically thereafter.
    (b)(1) Except as provided by paragraph (b)(2) of this section, when
a hazard in a raw material or other ingredient will be controlled by
the supplier and is one for which there is a reasonable probability
that exposure to the hazard will result in serious adverse health
consequences or death to humans or animals:
    (i) The appropriate supplier verification activity is an onsite
audit of the supplier; and
    (ii) The audit must be conducted before using the raw material or
other ingredient from the supplier and at least annually thereafter.
    (2) The requirements of paragraph (b)(1) of this section do not
apply if there is a written determination that other verification
activities and/or less frequent onsite auditing of the supplier provide
adequate assurance that the hazards are controlled.
    (c) If a supplier is a qualified facility as defined by Sec.
507.3, the receiving facility does not need to comply with paragraphs
(a) and (b) of this section if the receiving facility:
    (1) Obtains written assurance that the supplier is a qualified
facility as defined by Sec.  507.3:
    (i) Before first approving the supplier for an applicable calendar
year; and
    (ii) On an annual basis thereafter, by December 31 of each calendar
year, for the following calendar year; and
    (2) Obtains written assurance, at least every 2 years, that the
supplier is producing the raw material or other ingredient in
compliance with applicable FDA food safety regulations (or, when
applicable, relevant laws and regulations of a country whose food
safety system FDA has officially recognized as comparable or has
determined to be equivalent to that of the United States). The written
assurance must include either:
    (i) A brief description of the preventive controls that the
supplier is implementing to control the applicable hazard in the animal
food; or
    (ii) A statement that the facility is in compliance with State,
local, county, tribal or other applicable non-Federal food safety laws,
including relevant laws and regulations of foreign counties.
    (d) If a supplier is a farm that grows produce and is not a covered
farm under part 112 of this chapter in accordance with Sec.  112.4(a),
or in accordance with Sec. Sec.  112.4(b) and 112.5, the receiving
facility does not need to comply with paragraphs (a) and (b) of this
section for produce that the receiving facility receives from the farm
as a raw material or other ingredient if the receiving facility:

    (1) Obtains written assurance that the raw material or other
ingredient provided by the supplier is not subject to part 112 of this
chapter in accordance with Sec.  112.4(a), or in accordance with
Sec. Sec.  112.4(b) and 112.5:
    (i) Before first approving the supplier for an applicable calendar
year; and
    (ii) On an annual basis thereafter, by December 31 of each calendar
year, for the following calendar year; and
    (2) Obtains written assurance, at least every 2 years, that the
farm acknowledges that its food is subject to section 402 of the
Federal Food, Drug, and Cosmetic Act (or, when applicable, that its
food is subject to relevant laws and regulations of a country whose
food safety system FDA has officially recognized as comparable or has
determined to be equivalent to that of the United States).
    (e) If a supplier is a shell egg producer that is not subject to
the requirements of part 118 of this chapter because it has less than
3,000 laying hens, the receiving facility does not need to comply with
paragraphs (a) and (b) of this section if the receiving facility:
    (1) Obtains written assurance that the shell eggs produced by the
supplier are not subject to part 118 because the shell egg producer has
less than 3,000 laying hens:
    (i) Before first approving the supplier for an applicable calendar
year; and
    (ii) On an annual basis thereafter, by December 31 of each calendar
year, for the following calendar year; and
    (2) Obtains written assurance, at least every 2 years, that the
shell egg producer acknowledges that its food is subject to section 402
of the Federal Food, Drug, and Cosmetic Act (or, when applicable, that
its food is subject to relevant laws and regulations of a country whose
food safety system FDA has officially recognized as comparable or has
determined to be equivalent to that of the United States).
    (f) There must not be any financial conflicts of interest that
influence the results of the verification activities listed in Sec.
507.110(b) and payment must not be related to the results of the
activity.

Sec.  507.135  Onsite audit.

    (a) An onsite audit of a supplier must be performed by a qualified
auditor.
    (b) If the raw material or other ingredient at the supplier is
subject to one or more FDA food safety regulations, an onsite audit
must consider such regulations and include a review of the supplier's
written plan (e.g., Hazard Analysis and Critical Control Point (HACCP)
plan or other food safety plan), if any, and its implementation, for
the hazard being controlled (or, when applicable, an onsite audit may
consider relevant laws and regulations of a country whose food safety
system FDA has officially recognized as comparable or has determined to
be equivalent to that of the United States).
    (c)(1) The following may be substituted for an onsite audit,
provided that the inspection was conducted within 1 year of the date
that the onsite audit would have been required to be conducted:
    (i) The written results of an appropriate inspection of the
supplier for compliance with applicable FDA food safety regulations by
FDA, by representatives of other Federal Agencies (such as the United
States Department of Agriculture), or by representatives of State,
local, tribal, or territorial agencies; or
    (ii) For a foreign supplier, the written results of an inspection
by FDA or the food safety authority of a country whose food safety
system FDA has officially recognized as comparable or has determined to
be equivalent to that of the United States.
    (2) For inspections conducted by the food safety authority of a
country whose food safety system FDA has officially recognized as
comparable or determined to be equivalent, the animal food that is the
subject of the onsite audit must be within the scope of the official
recognition or equivalence determination, and the foreign supplier must
be in, and under the regulatory oversight of, such country.
    (d) If the onsite audit is solely conducted to meet the
requirements of this subpart by an audit agent of a certification body
that is accredited in accordance with regulations in part 1, subpart M
of this chapter, the audit is not subject to the requirements in those
regulations.

Sec.  507.175  Records documenting the supply-chain program.

    (a) The records documenting the supply-chain program are subject to
the requirements of subpart F of this part.
    (b) The receiving facility must review the records listed in
paragraph (c) of this section in accordance with Sec.  507.49(a)(4).
    (c) The receiving facility must document the following in records
as applicable to its supply-chain program:
    (1) The written supply-chain program;
    (2) Documentation that a receiving facility that is an importer is
in compliance with the foreign supplier verification program
requirements under part 1, subpart L of this chapter, including
documentation of verification activities conducted under Sec.  1.506(e)
of this chapter;
    (3) Documentation of the approval of a supplier;
    (4) Written procedures for receiving raw materials and other
ingredients;
    (5) Documentation demonstrating use of the written procedures for
receiving raw materials and other ingredients;
    (6) Documentation of the determination of the appropriate supplier
verification activities for raw materials and other ingredients;
    (7) Documentation of the conduct of an onsite audit. This
documentation must include:
    (i) The name of the supplier subject to the onsite audit;
    (ii) Documentation of audit procedures;
    (iii) The dates the audit was conducted;
    (iv) The conclusions of the audit;
    (v) Corrective actions taken in response to significant
deficiencies identified during the audit; and
    (vi) Documentation that the audit was conducted by a qualified
auditor;
    (8) Documentation of sampling and testing conducted as a supplier
verification activity. This documentation must include:
    (i) Identification of the raw material or other ingredient tested
(including lot number, as appropriate) and the number of samples
tested;
    (ii) Identification of the test(s) conducted, including the
analytical method(s) used;
    (iii) The date(s) on which the test(s) were conducted and the date
of the report;
    (iv) The results of the testing;
    (v) Corrective actions taken in response to detection of hazards;
and
    (vi) Information identifying the laboratory conducting the testing;
    (9) Documentation of the review of the supplier's relevant food
safety records. This documentation must include:
    (i) The name of the supplier whose records were reviewed;
    (ii) The date(s) of review;
    (iii) The general nature of the records reviewed;
    (iv) The conclusions of the review; and
    (v) Corrective actions taken in response to significant
deficiencies identified during the review;
    (10) Documentation of other appropriate supplier verification
activities based on the supplier performance and the risk associated
with the raw material or other ingredient;
    (11) Documentation of any determination that verification
activities

other than an onsite audit, and/or less frequent onsite auditing of a
supplier, provide adequate assurance that the hazards are controlled
when a hazard in a raw material or other ingredient will be controlled
by the supplier and is one for which there is a reasonable probability
that exposure to the hazard will result in serious adverse health
consequences or death to humans or animals;
    (12) The following documentation of an alternative verification
activity for a supplier that is a qualified facility:
    (i) The written assurance that the supplier is a qualified facility
as defined by Sec.  507.3; and
    (ii) The written assurance that the supplier is producing the raw
material or other ingredient in compliance with applicable FDA food
safety regulations (or, when applicable, relevant laws and regulations
of a country whose food safety system FDA has officially recognized as
comparable or has determined to be equivalent to that of the United
States);
    (13) The following documentation of an alternative verification
activity for a supplier that is a farm that supplies a raw material or
other ingredient and is not a covered farm under part 112 of this
chapter:
    (i) The written assurance that supplier is not a covered farm under
part 112 of this chapter in accordance with Sec.  112.4(a), or in
accordance with Sec. Sec.  112.4(b) and 112.5; and
    (ii) The written assurance that the farm acknowledges that its food
is subject to section 402 of the Federal Food, Drug, and Cosmetic Act
(or, when applicable, that its food is subject to relevant laws and
regulations of a country whose food safety system FDA has officially
recognized as comparable or has determined to be equivalent to that of
the United States);
    (14) The following documentation of an alternative verification
activity for a supplier that is a shell egg producer that is not
subject to the requirements established in part 118 of this chapter
because it has less than 3,000 laying hens:
    (i) The written assurance that the shell eggs provided by the
supplier are not subject to part 118 of this chapter because the
supplier has less than 3,000 laying hens; and
    (ii) The written assurance that the shell egg producer acknowledges
that its food is subject to section 402 of the Federal Food, Drug, and
Cosmetic Act (or, when applicable, that its food is subject to relevant
laws and regulations of a country whose safety system FDA has
officially recognized as comparable or has determined to be equivalent
to that of the United States);
    (15) The written results of an appropriate inspection of the
supplier for compliance with applicable FDA food safety regulations by
FDA, by representatives of other Federal Agencies (such as the United
States Department of Agriculture), or by representatives from State,
local, tribal, or territorial agencies, or the food safety authority of
another country when the results of such an inspection is substituted
for an onsite audit;
    (16) Documentation of actions taken with respect to supplier non-
conformance;
    (17) Documentation of verification of a supply-chain-applied
control applied by an entity other than the receiving facility's
supplier; and
    (18) When applicable, documentation of the receiving facility's
review and assessment of:
    (i) Applicable documentation from an entity other than the
receiving facility that written procedures for receiving raw materials
and other ingredients are being followed;
    (ii) Applicable documentation, from an entity other than the
receiving facility, of the determination of the appropriate supplier
verification activities for raw materials and other ingredients;
    (iii) Applicable documentation, from an entity other than the
receiving facility, of conducting the appropriate supplier verification
activities for raw materials and other ingredients;
    (iv) Applicable documentation, from its supplier, of:
    (A) The results of sampling and testing conducted by the supplier;
or
    (B) The results of an audit conducted by a third-party qualified
auditor in accordance with Sec. Sec.  507.130(f) and 507.135; and
    (v) Applicable documentation, from an entity other than the
receiving facility, of verification activities when a supply-chain-
applied control is applied by an entity other than the receiving
facility's supplier.

Subpart F--Requirements Applying to Records That Must Be
Established and Maintained

Sec.  507.200  Records subject to the requirements of this subpart.

    (a) Except as provided by paragraphs (d) and (e) of this section,
all records required by this part are subject to all requirements of
this subpart.
    (b) Records obtained by FDA in accordance with this part are
subject to the disclosure requirements under part 20 of this chapter.
    (c) All records required by this part must be made promptly
available to a duly authorized representative of the Secretary of
Health and Human Services for official review and copying upon oral or
written request.
    (d) The requirements of Sec.  507.206 apply only to the written
food safety plan.
    (e) The requirements of Sec.  507.202(a)(2), (4), and (5) and (b)
do not apply to the records required by Sec.  507.7.

Sec.  507.202  General requirements applying to records.

    (a) Records must:
    (1) Be kept as original records, true copies (such as photocopies,
pictures, scanned copies, microfilm, microfiche, or other accurate
reproductions of the original records), or electronic records;
    (2) Contain the actual values and observations obtained during
monitoring and as appropriate, during verification activities;
    (3) Be accurate, indelible, and legible;
    (4) Be created concurrently with performance of the activity
documented; and
    (5) Be as detailed as necessary to provide history of work
performed.
    (b) All records must include:
    (1) Information adequate to identify the plant or facility (e.g.,
the name, and when necessary, the location of the plant or facility);
    (2) The date and, when appropriate, the time of the activity
documented;
    (3) The signature or initials of the person performing the
activity; and
    (4) Where appropriate, the identity of the product and the lot
code, if any.
    (c) Records that are established or maintained to satisfy the
requirements of this part and that meet the definition of electronic
records in Sec.  11.3(b)(6) of this chapter are exempt from the
requirements of part 11 of this chapter. Records that satisfy the
requirements of this part, but that also are required under other
applicable statutory provisions or regulations, remain subject to part
11 of this chapter.

Sec.  507.206  Additional requirements applying to the food safety
plan.

    The owner, operator, or agent in charge of the facility must sign
and date the food safety plan upon initial completion and upon any
modification.

Sec.  507.208  Requirements for record retention.

    (a)(1) All records required by this part must be retained at the
plant or facility for at least 2 years after the date they were
prepared.
    (2) Records that a facility relies on during the 3-year period
preceding the

applicable calendar year to support its status as a qualified facility
must be retained at the facility as long as necessary to support the
status of a facility as a qualified facility during the applicable
calendar year.
    (b) Records that relate to the general adequacy of the equipment or
processes being used by a facility, including the results of scientific
studies and evaluations, must be retained by the facility for at least
2 years after their use is discontinued (e.g., because the facility has
updated the written food safety plan (Sec.  507.31) or records that
document validation of the written food safety plan (Sec.  507.45(b))).
    (c) Except for the food safety plan, offsite storage of records is
permitted if such records can be retrieved and provided onsite within
24 hours of request for official review. The food safety plan must
remain onsite. Electronic records are considered to be onsite if they
are accessible from an onsite location.
    (d) If the plant or facility is closed for a prolonged period, the
food safety plan may be transferred to some other reasonably accessible
location but must be returned to the plant or facility within 24 hours
for official review upon request.

Sec.  507.212  Use of existing records.

    (a) Existing records (e.g., records that are kept to comply with
other Federal, State, or local regulations, or for any other reason) do
not need to be duplicated if they contain all of the required
information and satisfy the requirements of this subpart. Existing
records may be supplemented as necessary to include all of the required
information and satisfy the requirements of this subpart.
    (b) The information required by this part does not need to be kept
in one set of records. If existing records contain some of the required
information, any new information required by this part may be kept
either separately or combined with the existing records.

Sec.  507.215  Special requirements applicable to a written assurance.

    (a) Any written assurance required by this part must contain the
following elements:
    (1) Effective date;
    (2) Printed names and signatures of authorized officials;
    (3) The applicable assurance under:
    (i) Sec.  507.36(a)(2);
    (ii) Sec.  507.36(a)(3);
    (iii) Sec.  507.36(a)(4);
    (iv) Sec.  507.130(c)(2);
    (v) Sec.  507.130(d)(2); or
    (vi) Sec.  507.130(e)(2).
    (b) A written assurance required under Sec.  507.36(a)(2), (3) or
(4) must include:
    (1) Acknowledgement that the facility that provides the written
assurance assumes legal responsibility to act consistently with the
assurance and document its actions taken to satisfy the written
assurance; and
    (2) Provision that if the assurance is terminated in writing by
either entity, responsibility for compliance with the applicable
provisions of this part reverts to the manufacturer/processor as of the
date of termination.

PART 579--IRRADIATION IN THE PRODUCTION, PROCESSING, AND HANDLING
OF ANIMAL FEED AND PET FOOD

0
10. The authority citation for 21 CFR part 579 continues to read as
follows:

    Authority: 21 U.S.C. 321, 342, 343, 348, 371.

0
11. In Sec.  579.12, add the following sentence to the end of the
paragraph to read as follows:

Sec.  579.12  Incorporation of regulations in part 179.

    * * * Any facility that treats animal feed and pet food with
ionizing radiation must comply with the requirements of part 507 of
this chapter and other applicable regulations.

    Dated:August 31, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-21921 Filed 9-10-15; 8:45 am]
 BILLING CODE 4164-01-P