[Federal Register Volume 82, Number 24 (Tuesday, February 7, 2017)]
[Notices]
[Pages 9586-9590]
[FR Doc No: 2017-02410]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2016-0002]

Changes in Flood Hazard Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Final notice.

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SUMMARY: New or modified Base (1-percent annual chance) Flood
Elevations (BFEs), base flood depths, Special Flood Hazard Area (SFHA)
boundaries or zone designations, and/or regulatory floodways
(hereinafter referred to as flood hazard determinations) as shown on
the indicated Letter of Map Revision (LOMR) for each of the communities
listed in the table below are finalized. Each LOMR revises the Flood
Insurance Rate Maps (FIRMs), and in some cases the Flood Insurance
Study (FIS) reports, currently in effect for the listed communities.
The flood hazard determinations modified by each LOMR will be used to
calculate flood insurance premium rates for new buildings and their
contents.

DATES: The effective date for each LOMR is indicated in the table
below.

ADDRESSES: Each LOMR is available for inspection at both the respective
Community Map Repository address listed in the table below and online

through the FEMA Map Service Center at www.msc.fema.gov.

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

SUPPLEMENTARY INFORMATION: The Federal Emergency Management Agency
(FEMA) makes the final flood hazard determinations as shown in the
LOMRs for each community listed in the table below. Notice of these
modified flood hazard determinations has been published in newspapers
of local circulation and 90 days have elapsed since that publication.
The Deputy Associate Administrator for Insurance and Mitigation has
resolved any appeals resulting from this notification.
    The modified flood hazard determinations 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 new or modified flood hazard information is 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 remain
qualified for participation in the National Flood Insurance Program
(NFIP).
    This new or modified flood hazard information, 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.
    This new or modified flood hazard determinations are used to meet
the floodplain management requirements of the NFIP and also are used to
calculate the appropriate flood insurance premium rates for new
buildings, and for the contents in those buildings. The changes in
flood hazard determinations are in accordance with 44 CFR 65.4.
    Interested lessees and owners of real property are encouraged to
review the final flood hazard information available at the address
cited below for each community or online through the FEMA Map Service
Center at www.msc.fema.gov.

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

    Date: December 21, 2016.
Roy E. Wright,
Deputy Associate Administrator for Insurance and Mitigation, Department
of Homeland Security, Federal Emergency Management Agency.

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                                                            Chief executive officer       Community map                                       Community
         State and county           Location and case No.         of community             repository        Effective date of modification      No.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Alabama:
    Etowah (FEMA Docket No.: B-     City of Gadsden (16-   The Honorable Sherman      City Hall, 90 Broad   October 6, 2016................       010080
     1645).                          04-2081P).             Guyton, Mayor, City of     Street, Gadsden, AL
                                                            Gadsden, 90 Broad          35902.
                                                            Street, Gadsden, AL
                                                            35902.
    Etowah (FEMA Docket No.: B-     City of Rainbow City   The Honorable Terry J.     City Hall, 3700       October 6, 2016................       010351
     1645).                          (16-04-2081P).         Calhoun, Mayor, City of    Rainbow Drive,
                                                            Rainbow City, 3700         Rainbow City, AL
                                                            Rainbow Drive, Rainbow     35906.
                                                            City, AL 35906.
    Etowah (FEMA Docket No.: B-     Unincorporated areas   The Honorable Lewis        Etowah County         October 6, 2016................       010077
     1645).                          of Etowah County (16-  Fuller, President,         Courthouse, 800
                                     04-2081P).             Etowah County              Forrest Avenue,
                                                            Commission, 800 Forrest    Suite 3, Gadsden,
                                                            Avenue, Suite 113,         AL 35901.
                                                            Gadsden, AL 35901.
    Jefferson (FEMA Docket No.: B-  City of Trussville     The Honorable Eugene       City Hall, 131 Main   September 29, 2016.............       010133
     1645).                          (15-04-A460P).         Melton, Mayor, City of     Street, Trussville,
                                                            Trussville, 131 Main       AL 35173.
                                                            Street, Trussville, AL
                                                            35173.
    Jefferson (FEMA Docket No.: B-  Unincorporated areas   The Honorable James A.     Jefferson County      September 29, 2016.............       010217
     1645).                          of Jefferson County    Stephens, Chairman,        Land Development
                                     (15-04-A460P).         Jefferson County           Department, 716
                                                            Commission, 716 Richard    Richard Arrington
                                                            Arrington Jr. Boulevard    Jr. Boulevard
                                                            North, Birmingham, AL      North, Birmingham,
                                                            35203.                     AL 35203.
Arkansas:
    Pulaski (FEMA Docket No.: B-    City of North Little   The Honorable Joe Smith,   Planning Department,  September 23, 2016.............       050182
     1637).                          Rock (15-06-4244P).    Mayor, City of North       120 Main Street,
                                                            Little Rock, P.O. Box      North Little Rock,
                                                            5757, North Little Rock,   AR 72114.
                                                            AR 72119.
    Pulaski (FEMA Docket No.: B-    City of Sherwood (15-  The Honorable Virginia     Engineering, Permit   September 23, 2016.............       050235
     1637).                          06-4244P).             Hillman Young, Mayor,      and Planning
                                                            City of Sherwood, P.O.     Department, 2199
                                                            Box 6256, Sherwood, AR     East Kiehl Avenue,
                                                            72120.                     Sherwood, AR 72124.
    Sebastian (FEMA Docket No.: B-  City of Fort Smith     Mr. Jeff Dingman, Acting   City Hall, 623        October 6, 2016................       055013
     1645).                          (15-06-0085P).         Administrator, City of     Garrison Avenue,
                                                            Fort Smith, P.O. Box       Fort Smith, AR
                                                            1908, Fort Smith, AR       72901.
                                                            72902.
Colorado:
    Denver (FEMA Docket No.: B-     City and County of     The Honorable Michael B.   Department of Public  September 29, 2016.............       080046
     1637).                          Denver (16-08-0657P).  Hancock, Mayor, City and   Works, 201 West
                                                            County of Denver, 1437     Colfax Avenue,
                                                            Bannock Street, Suite      Denver, CO 80202.
                                                            350, Denver, CO 80202.
    El Paso (FEMA Docket No.: B-    City of Fountain (16-  The Honorable Gabriel      Planning Division,    September 29, 2016.............       080061
     1637).                          08-0082P).             Ortega, Mayor, City of     116 South Main
                                                            Fountain, 116 South Main   Street, Fountain,
                                                            Street, Fountain, CO       CO 80817.
                                                            80817.
    El Paso (FEMA Docket No.: B-    Unincorporated areas   The Honorable Amy Lathen,  El Paso County        September 29, 2016.............       080059
     1637).                          of El Paso County      Chair, El Paso County      Regional
                                     (16-08-0082P).         Board of Commissioners,    Development Center,
                                                            200 South Cascade          2880 International
                                                            Avenue, Suite 100,         Circle, Colorado
                                                            Colorado Springs, CO       Springs, CO 80910.
                                                            80903.

    Jefferson (FEMA Docket No.: B-  Unincorporated areas   The Honorable Libby        Jefferson County      October 7, 2016................       080087
     1645).                          of Jefferson County    Szabo, Chair, Jefferson    Planning and Zoning
                                     (15-08-0549P).         County Board of            Division, 100
                                                            Commissioners, 100         Jefferson County
                                                            Jefferson County           Parkway, Golden, CO
                                                            Parkway, Golden, CO        80419.
                                                            80419.
Connecticut:
    Fairfield (FEMA Docket No.: B-  Town of Trumbull (16-  The Honorable Timothy M.   Town Hall, 5866 Main  September 23, 2016.............       090017
     1637).                          01-0265P).             Herbst, First Selectman,   Street, Trumbull,
                                                            Town of Trumbull Board     CT 06611.
                                                            of Selectmen, 5866 Main
                                                            Street, Trumbull, CT
                                                            06611.
    Middlesex (FEMA Docket No.: B-  Town of Old Saybrook   The Honorable Carl P.      Town Hall, 302 Main   October 7, 2016................       090069
     1645).                          (16-01-0590P).         Fortuna, Jr., First        Street, Old
                                                            Selectman, Town of Old     Saybrook, CT 06475.
                                                            Saybrook Board of
                                                            Selectmen, 302 Main
                                                            Street, Old Saybrook, CT
                                                            06475.
Florida:
    Collier (FEMA Docket No.: B-    City of Marco Island   The Honorable Bob Brown,   City Hall, 50 Bald    October 7, 2016................       120426
     1645).                          (16-04-2785P).         Chairman, City of Marco    Eagle Drive, Marco
                                                            Island Council, 50 Bald    Island, FL 34145.
                                                            Eagle Drive, Marco
                                                            Island, FL 34145.
    Flagler (FEMA Docket No.: B-    City of Bunnell (16-   The Honorable Catherine    City Hall, 201 West   September 22, 2016.............       120086
     1637).                          04-2729P).             Robinson, Mayor, City of   Moody Boulevard,
                                                            Bunnell, P.O. Box 756,     Bunnell, FL 32110.
                                                            Bunnell, FL 32110.
    Flagler (FEMA Docket No.: B-    City of Palm Coast     The Honorable Jon Netts,   City Hall, 160 Lake   September 22, 2016.............       120684
     1637).                          (16[dash]04[dash]272   Mayor, City of Palm        Avenue, Palm Coast,
                                     9P).                   Coast, 160 Lake Avenue,    FL 32164.
                                                            Palm Coast, FL 32164.
    Hillsborough (FEMA Docket No.:  Unincorporated areas   Mr. Mike Merrill,          Hillsborough County   September 26, 2016.............       120112
     B-1637).                        of Hillsborough        Hillsborough County        Administrator's
                                     County (16-04-3005P).  Administrator, P.O. Box    Office, 601 East
                                                            1110, Tampa, FL 33601.     Kennedy Boulevard,
                                                                                26th Floor, Tampa,
                                                                                FL 33602.
    Orange (FEMA Docket No.: B-     Unincorporated areas   The Honorable Teresa       Orange County         September 19, 2016.............       120179
     1637).                          of Orange County (16-  Jacobs, Mayor, Orange      Government Office,
                                     04-4432X).             County, 201 South          201 South Rosalind
                                                            Rosalind Avenue, 5th       Avenue, 1st Floor,
                                                            Floor, Orlando, FL 32801.  Orlando, FL 32801.
    Volusia (FEMA Docket No.: B-    City of DeBary (16-04- The Honorable Clint        City Hall, 16         October 5, 2016................       130322
     1645).                          4470P).                Johnson, Mayor, City of    Colomba Road,
                                                            DeBary, 16 Colomba Road,   DeBary, FL 32713.
                                                            DeBary, FL 32713.
Georgia:
    Grady (FEMA Docket No.: B-      Unincorporated areas   The Honorable Charlie      Grady County Code     September 29, 2016.............       130096
     1637).                          of Grady County (16-   Norton, Chairman, Grady    Enforcement
                                     04-4551X).             County Board of            Division, 250 North
                                                            Commissioners, 250 North   Broad Street,
                                                            Broad Street, Cairo, GA    Cairo, GA 39828.
                                                            39828.
    Gwinnett (FEMA Docket No.: B-   Unincorporated areas   The Honorable Charlotte    Gwinnett County       October 11, 2016...............       130322
     1645).                          of Gwinnett County     J. Nash, Chair, Gwinnett   Stormwater
                                     (16-04-2468P).         County Board of            Management
                                                            Commissioners, 75          Division, 684
                                                            Langley Drive,             Winder Highway,
                                                            Lawrenceville, GA 30046.   Lawrenceville, GA
                                                                                30045.
    Lee (FEMA Docket No.: B-1645).  City of Leesburg (16-  The Honorable Jim Quinn,   City Hall, 107        October 13, 2016...............       130348
                                     04-3621P).             Mayor, City of Leesburg,   Walnut Avenue
                                                            P.O. Box 890, Leesburg,    South, Leesburg, GA
                                                            GA 31763.                  31763.
    Lee (FEMA Docket No.: B-1645).  Unincorporated areas   The Honorable Rick         Lee County            October 13, 2016...............       130122
                                     of Lee County (16-04-  Muggridge, Chairman, Lee   Administration
                                     3621P).                County Board of            Building, 110
                                                            Commissioners, 110         Starksville Avenue
                                                            Starksville Avenue         North, Leesburg, GA
                                                            North, Leesburg, GA        31763.
                                                            31763.
Kentucky:
    Hardin (FEMA Docket No.: B-     City of Elizabethtown  The Honorable Edna         City Hall, 200 West   September 19, 2016.............       210095
     1637).                          (15-04-8215P).         Berger, Mayor, City of     Dixie Avenue,
                                                            Elizabethtown, P.O. Box    Elizabethtown, KY
                                                            550, Elizabethtown, KY     42701.
                                                            42702.
    Hardin (FEMA Docket No.: B-     Unincorporated areas   The Honorable Harry L.     Hardin County         September 19, 2016.............       210094
     1637).                          of Hardin County (15-  Berry, Hardin County       Government
                                     04-8215P).             Judge/Executive, P.O.      Building, 150 North
                                                            Box 568, Elizabethtown,    Provident Way,
                                                            KY 42702.                  Elizabethtown, KY
                                                                                42701.
Maine: Knox (FEMA Docket No.: B-    Town of Owls Head (16- The Honorable Linda Post,  Town Hall, 224 Ash    September 23, 2016.............       230075
 1637).                              01-1529P).             Chair, Town of Owls Head   Point Drive, Owls
                                                            Board of Selectmen, P.O.   Head, ME 04854.
                                                            Box 128, Owls Head, ME
                                                            04854.
Massachusetts:
    Norfolk (FEMA Docket No.: B-    Town of Weymouth (15-  The Honorable Robert L.    City Hall, 75 Middle  September 29, 2016.............       250257
     1645).                          01-2574P).             Hedlund, Mayor, Town of    Street, Weymouth,
                                                            Weymouth, 75 Middle        MA 02189.
                                                            Street, Weymouth, MA
                                                            02189.
    Worcester (FEMA Docket No.: B-  City of Fitchburg (15- The Honorable Stephen L.   Community             October 6, 2016................       250304
     1645).                          01-2126P).             DiNatale, Mayor, City of   Development
                                                            Fitchburg, 166 Boulder     Department,
                                                            Drive, Suite 108,          Planning Division,
                                                            Fitchburg, MA 01420.       301 Broad Street,
                                                                                Fitchburg, MA 01420.
    Worcester (FEMA Docket No.: B-  City of Leominster     The Honorable Dean J.      Office of Emergency   October 6, 2016................       250314
     1645).                          (15-01-2126P).         Mazzarella, Mayor, City    Management, 37
                                                            of Leominster, 25 West     Carter Street,
                                                            Street, Leominster, MA     Leominster, MA
                                                            01453.                     01453.
Oklahoma:
    Oklahoma (FEMA Docket No.: B-   City of The Village    The Honorable Hutch        Building and Code     October 10, 2016...............       400420
     1637).                          (14-06-4742P).         Hibbard, Mayor, City of    Department, 2304
                                                            The Village, 2304          Manchester Drive,
                                                            Manchester Drive, The      The Village, OK
                                                            Village, OK 73120.         73120.
    Tulsa (FEMA Docket No.: B-      City of Broken Arrow   The Honorable Craig        Operations Building,  October 3, 2016................       400236
     1637).                          (14-06-4075P).         Thurmond, Mayor, City of   485 North Poplar
                                                            Broken Arrow, 220 South    Avenue, Broken
                                                            1st Street, Broken         Arrow, OK 74012.
                                                            Arrow, OK 74012.

    Wagoner (FEMA Docket No.: B-    Unincorporated areas   The Honorable Chris        Wagoner County        October 3, 2016................       400215
     1637).                          of Wagoner County      Edwards, Chairman,         Courthouse, 307
                                     (14-06-4075P).         Wagoner County Board of    East Cherokee
                                                            Commissioners, P.O. Box    Street, Wagoner, OK
                                                            156, Wagoner, OK 74477.    74467.
South Carolina:
    Charleston (FEMA Docket No.: B- Town of Mount          The Honorable Linda Page,  Planning Department,  October 3, 2016................       455417
     1637).                          Pleasant (16-04-       Mayor, Town of Mount       100 Ann Edwards
                                     3547P).                Pleasant, 100 Ann          Lane, Mount
                                                            Edwards Lane, Mount        Pleasant, SC 29464.
                                                            Pleasant, SC 29464.
    Charleston (FEMA Docket No.: B- Unincorporated areas   The Honorable J. Elliott   Charleston County     October 3, 2016................       455413
     1637).                          of Charleston County   Summey, Chairman,          Building Inspection
                                     (16-04-3547P).         Charleston County Board    Services
                                                            of Commissioners, 4045     Department, 4045
                                                            Bridge View Drive, North   Bridge View Drive,
                                                            Charleston, SC 29405.      North Charleston,
                                                                                SC 29405.
    Horry (FEMA Docket No.: B-      City of Myrtle Beach   The Honorable John T.      Construction          September 26, 2016.............       450109
     1645).                          (16-04-2072P).         Rhodes, Mayor, City of     Services
                                                            Myrtle Beach, P.O. Box     Department, 921
                                                            2468, Myrtle Beach, SC     North Oak Street,
                                                            29577.                     Myrtle Beach, SC
                                                                                29577.
South Dakota:
    Minnehaha (FEMA Docket No.: B-  City of Hartford (16-  The Honorable Bill         City Hall, 125 North  September 23, 2016.............       460180
     1637).                          08-0101P).             Campbell, Mayor, City of   Main Avenue,
                                                            Hartford, 125 North Main   Hartford, SD 57033.
                                                            Avenue, Hartford, SD
                                                            57033.
    Minnehaha (FEMA Docket No.: B-  Unincorporated areas   The Honorable Cindy        Minnehaha County      September 23, 2016.............       460057
     1637).                          of Minnehaha County    Heiberger, Chair,          Administration
                                     (16-08-0101P).         Minnehaha County Board     Building, 415 North
                                                            of Commissioners, 415      Dakota Avenue,
                                                            North Dakota Avenue,       Sioux Falls, SD
                                                            Sioux Falls, SD 57104.     57104.
Tennessee:
    Washington (FEMA Docket No.: B- City of Johnson City   The Honorable Clayton      Public Works          September 29, 2016.............       480582
     1637).                          (16-04-1191P).         Stout, Mayor, City of      Department, 601
                                                            Johnson City, 601 East     East Main Street,
                                                            Main Street, Johnson       Johnson City, TN
                                                            City, TN 37601.            37601.
    Washington (FEMA Docket No.: B- Unincorporated areas   The Honorable Dan          Washington County     September 29, 2016.............       470265
     1637).                          of Washington County   Eldridge, Mayor,           Zoning Department,
                                     (16-04-1191P).         Washington County, 100     100 East Main
                                                            East Main Street,          Street,
                                                            Jonesborough, TN 37659.    Jonesborough, TN
                                                                                37659.
    Williamson (FEMA Docket No.: B- City of Franklin (15-  The Honorable Ken Moore,   City Hall, 109 3rd    September 30, 2016.............       470206
     1645).                          04-8778P).             Mayor, City of Franklin,   Avenue South,
                                                            109 3rd Avenue South,      Franklin, TN 37064.
                                                            Franklin, TN 37064.
Texas:
    Collin (FEMA Docket No.: B-     City of Frisco (16-06- The Honorable Maher Maso,  Engineering Services  September 19, 2016.............       480134
     1637).                          0556P).                Mayor, City of Frisco,     Department, 6101
                                                            6101 Frisco Square         Frisco Square
                                                            Boulevard, Frisco, TX      Boulevard, Frisco,
                                                            75034.                     TX 75034.
    Collin (FEMA Docket No.: B-     City of McKinney (16-  The Honorable Brian        Engineering           October 3, 2016................       480135
     1637).                          06-0082P).             Loughmiller, Mayor, City   Department, 221
                                                            of McKinney, P.O. Box      North Tennessee
                                                            517, McKinney, TX 75070.   Street, McKinney,
                                                                                TX 75069.
    Collin (FEMA Docket No.: B-     City of McKinney (16-  The Honorable Brian        Engineering           September 12, 2016.............       480135
     1637).                          06-0593P).             Loughmiller, Mayor, City   Department, 221
                                                            of McKinney, P.O. Box      North Tennessee
                                                            517, McKinney, TX 75070.   Street, McKinney,
                                                                                TX 75069.
    Collin (FEMA Docket No.: B-     City of McKinney (16-  The Honorable Brian        Engineering           October 10, 2016...............       480135
     1645).                          06-0922P).             Loughmiller, Mayor, City   Department, 221
                                                            of McKinney, P.O. Box      North Tennessee
                                                            517, McKinney, TX 75070.   Street, McKinney,
                                                                                TX 75069.
    Collin (FEMA Docket No.: B-     City of Melissa (16-   Mr. Jason Little,          City Hall, 3411       October 10, 2016...............       481626
     1645).                          06-0922P).             Manager, City of           Barker Avenue,
                                                            Melissa, 3411 Barker       Melissa, TX 75454.
                                                            Avenue, Melissa, TX
                                                            75454.
    Collin (FEMA Docket No.: B-     Unincorporated areas   The Honorable Keith Self,  Collin County         October 10, 2016...............       480130
     1645).                          of Collin County (16-  Collin County Judge,       Engineering
                                     06-0922P).             2300 Bloomdale Road,       Department, 4690
                                                            Suite 4192, McKinney, TX   Community Avenue,
                                                            75071.                     Suite 200,
                                                                                McKinney, TX 75071.
    Dallas (FEMA Docket No.: B-     City of Coppell (16-   The Honorable Karen Hunt,  Engineering           October 3, 2016................       480170
     1637).                          06-0213P).             Mayor, City of Coppell,    Department, 265
                                                            P.O. Box 9478, Coppell,    Parkway Boulevard,
                                                            TX 75019.                  Coppell, TX 75019.
    Fort Bend (FEMA Docket No.: B-  Unincorporated areas   The Honorable Robert       Fort Bend County      September 30, 2016.............       480228
     1637).                          of Fort Bend County    Hebert, Fort Bend County   Engineering
                                     (16-06-0935P).         Judge, 401 Jackson         Department, 401
                                                            Street, Richmond, TX       Jackson Street,
                                                            77469.                     Richmond, TX 77469.
    Kendall (FEMA Docket No.: B-    Unincorporated areas   The Honorable Darrel L.    Kendall County        October 5, 2016................       480417
     1645).                          of Kendall County      Lux, Kendall County        Engineering
                                     (16-06-0702P).         Judge, 201 East San        Department, 201
                                                            Antonio Avenue, Suite      East San Antonio
                                                            122, Boerne, TX 78006.     Avenue, Suite 101,
                                                                                Boerne, TX 78006.
    Waller (FEMA Docket No.: B-     Unincorporated areas   The Honorable Carbett      Waller County Annex   September 30, 2016.............       480640
     1637).                          of Waller County (16-  ``Trey'' Duhon III,        Building, 775
                                     06-0935P).             Waller County Judge, 836   Business Highway
                                                            Austin Street, Suite       290 East,
                                                            203, Hempstead, TX 77445.  Hempstead, TX 77445.
Utah:
    Salt Lake (FEMA Docket No.: B-  Town of Herriman (16-  The Honorable Carmen       Town Hall, 13011      October 12, 2016...............       490252
     1645).                          08-0214P).             Freeman, Mayor, Town of    South Pioneer
                                                            Herriman, 13011 South      Street, Herriman,
                                                            Pioneer Street,            UT 84096.
                                                            Herriman, UT 84096.
    Tooele (FEMA Docket No.: B-     City of Tooele (16-08- The Honorable Patrick      Town Hall, 90 North   September 28, 2016.............       490145
     1645).                          0138P).                Dunlavy, Mayor, City of    Main Street,
                                                            Tooele, 90 North Main      Tooele, UT 84074.
                                                            Street, Tooele, UT 84074.

Virginia: Prince William (FEMA      Unincorporated areas   Mr. Christopher E.         Prince William        October 6, 2016................       510119
 Docket No.: B-1645)                 of Prince William      Martino, Acting Prince     County Department
                                     County (16-03-0170P).  William County             of Public Works, 5
                                                            Executive, 1 County        County Complex
                                                            Complex Court, Prince      Court, Prince
                                                            William, VA 22192.         William, VA 22192.
West Virginia:
    Harrison (FEMA Docket No.: B-   City of Bridgeport     The Honorable Robert       Engineering           October 11, 2016...............       540055
     1645).                          (15-03-0999P).         Greer, Mayor, City of      Department, 515
                                                            Bridgeport, 515 West       West Main Street,
                                                            Main Street, Bridgeport,   Bridgeport, WV
                                                            WV 26330.                  26330.
    Harrison (FEMA Docket No.: B-   Unincorporated areas   The Honorable Ronald       Harrison County       October 11, 2016...............       540053
     1645).                          of Harrison County     Watson, President,         Planning
                                     (15-03-0999P).         Harrison County            Department, 301
                                                            Commission, 301 West       West Main Street,
                                                            Main Street, Clarksburg,   Clarksburg, WV
                                                            WV 26301.                  26301.
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[FR Doc. 2017-02410 Filed 2-6-17; 8:45 am]
 BILLING CODE 9110-12-P


2
•
Certain information on the package
label, specifically: Lot number,
information on the preservative, number
of containers, recommended storage
temperature, certain instructions for
use, recommended individual dose,
route of administration, known
sensitizing substances, type and amount
of added antibiotics, inactive
ingredients, adjuvant, source of product,
identity of microorganisms used in
manufacture, and minimum potency
(§610.61(c) and (e) through (r));
•
Requirements relating to the
position and prominence of the proper
name on the package label as well as
requirements relating to size and type of
characters (21 CFR 610.62);
•
The placement on the container and
package label of the name, address, and
license information of each
manufacturer participating in the
manufacture of a biological product, if
two or more manufacturers participate
in manufacturing (21 CFR 610.63);
•
The name and address of the
distributor, and the required identifying
phrases on the label (21 CFR 610.64);
and
•
Label requirements relating to
products for export (21 CFR 610.65)
3. Medical Devices (§801.128(f))
For medical devices, the appropriate
FDA Center Director may grant a request
for an exception or alternative to certain
labeling requirements in parts 801 and
812 (21 CFR parts 801 and 812), except
to the extent that they are explicitly
required by statute:
•
Criteria for the statement of the
place of business (§801.1(d));
•
Labeling information on the
principal display panel of over-the-
counter devices in package form, i.e.,
the part of a label that is most likely to
be displayed, presented, shown, or
examined under customary conditions
of display for retail sale (§801.60);
•
Requirements related to an accurate
statement of principal intended action
and format of a statement of identity for
an over-the-counter device in package
form (§801.61);
•
Requirements related to the
declaration of net quantity of contents
on the label of an over-the-counter
device in package form (§801.62);
•
Warning statement for over-the-
counter devices containing or
manufactured with chlorofluorocarbons
and other class I ozone-depleting
substances (§801.63);
•
Labeling requirements for
prescription devices (§801.109);
•
Labeling requirements for specific
devices including dentures and hearing
aids (part 801, subpart H);
•
The prescribed statement for
investigational devices limiting the
device to investigational use (§812.5(a));
and
•
The prescribed statement for
investigational devices used solely on
research animals limiting the device to
investigational use in laboratory animals
(§812.5(c)).
4. In Vitro Diagnostic Products
(§809.11(f))
The appropriate FDA Center Director
may grant a request for an exception or
alternative to the following
requirements pertaining to IVDs in parts
809 (21 CFR part 809) and 812, except
to the extent that they are explicitly
required by statute.
•
Certain label information for IVDs,
i.e., the proprietary name; the intended
use or uses of the product; for a reagent,
the declaration of the established name,
if any, the quantity, proportion, and
concentration of each reactive
ingredient, and the source and activity
if derived from a biological material;
statement of warnings or precautions;
for a reagent, appropriate storage
instructions adequate to protect the
stability of the product; for a reagent, a
means by which the user may be
ensured that the product meets
appropriate standards of identity,
strength, quality and purity at the time
of use; and a lot or control number
(§809.10(a)(1) through (a)(6) and (a)(9));
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3
Section 3 of the Project BioShield Act of 2004
(section 319F–2 of the PHS Act (42 U.S.C. 247d–
6b)).
•
Labeling accompanying each IVD,
including reagents and instruments, i.e.,
such information as proprietary name,
intended use or uses, summary and
explanation of the test, a statement of
warnings or precautions for users,
information regarding specimen
collection and preparation for analysis,
outline of recommended procedures,
information regarding results, limitation
of the procedure, expected values,
specific performance characteristics,
and bibliography (§809.10(b));
•
The prescribed statements for
investigational IVDs that are not subject
to part 812 (§809.10(c)(2));
•
The label of general purpose
laboratory reagents, i.e., the proprietary
name; the quantity, proportion, or
concentration of the reagent ingredient;
and for a reagent derived from biological
material, the source and measure of
activity; statement of purity and quality
of the reagent; statement of warnings or
precautions; appropriate storage
instructions adequate to protect the
stability of the product; and a lot or
control number (§809.10(d)(1)(i)
through (d)(1)(v) and (d)(1)(viii));
•
Labeling of general purpose
laboratory equipment, i.e., description
of the product, its composition, and
physical characteristics if necessary for
use (§809.10(d)(2)); and
•
Labeling for analyte specific
reagents, i.e., the proprietary name; the
quantity, proportion, or concentration of
the reagent ingredient; and for a reagent
derived from biological material, the
source and measure of activity;
statement of purity and quality of the
reagent; statement of warnings or
precautions for users; date of
manufacture and appropriate storage
instructions adequate to protect the
stability of the product; a lot or control
number; prescribed statements
regarding analytical and performance
characteristics specific to class I, II, and
III analyte specific reagents
(§809.10(e)(1)(i) through (e)(1)(vi) and
(e)(1)(ix) through (e)(1)(xi)).
IV. Legal Authority
In this interim final rule, FDA is
amending regulations pertaining to the
content and format of medical product
labeling. The provisions of this rule will
allow FDA to grant exceptions or
alternatives to certain of those labeling
requirements. The labeling regulations
to which exceptions or alternatives will
be permitted were issued by FDA under
authority of the FFD&C Act and the PHS
Act to mandate particular ways that
firms must satisfy the broad
requirements and prohibitions in those
statutes, such as the prohibition on false
and misleading drug and device
labeling. As described in section II of
this document, FDA has determined
that circumstances may arise in which
compliance with those regulatory
mandates could adversely affect the
safety, effectiveness, or availability of
certain medical products that are or will
be included in the SNS. Moreover, due
to the unique nature of the SNS, those
products could deviate from particular
mandates of existing labeling
regulations without violating the broad
statutory requirements and prohibitions
in the FFD&C Act and the PHS Act. For
those reasons, FDA is exercising its
authority to regulate labeling by
modifying the existing regulations in a
way that will allow exceptions or
alternatives for medical products that
are or will be included in the SNS.
FDA has various sources of authority
to issue labeling regulations. For
example, under section 502(a) of the
FFD&C Act, a drug (including biological
products) or device is misbranded if its
labeling is false or misleading in any
particular. In determining whether a
product’s labeling is misleading, FDA
may consider not only representations
or suggestions made in the labeling, but
also whether the labeling fails to reveal
material facts in light of those
representations or suggestions or with
respect to consequences which may
result from the use of the product under
customary or usual conditions of use
(section 201(n) of the FFD&C Act (21
U.S.C. 321(n))). By authority delegated
under section 701(a) of the FFD&C Act
(21 U.S.C. 371(a)), FDA is authorized to
issue regulations for the efficient
enforcement of the FFD&C Act. Existing
FDA regulations mandating specific
labeling content and format for drugs
and devices satisfy those general
statutory standards. For example, many
labeling regulations are designed to
ensure that nothing in the labeling is
false or misleading in any particular, to
ensure that the labeling reveals all
material facts in light of the
representations or suggestions in the
labeling, and to ensure that FDA may
efficiently enforce those statutory
requirements as well as other
requirements of the FFD&C Act and the
PHS Act.
Because biological products are also
drugs as defined within the FFD&C Act,
the authority discussed previously
extends to regulations prescribing
content and format requirements for
biological product labeling. There is,
however, additional legal authority in
the PHS Act for this rule’s requirements
with respect to biological products
generally. For example, section
351(a)(1)(A) of the PHS Act provides
that no person may introduce or deliver
for introduction into interstate
commerce any biological product unless
a biologics license is in effect for the
product. By authority delegated under
section 351(a)(2)(A) of the PHS Act,
FDA is required to establish, by
regulation, requirements for the
approval, suspension, and revocation of
biologics licenses.
Because the SNS is intended ‘‘to
provide for the emergency health
security of the United States * * * in the
event of a bioterrorist attack or other
public health emergency,’’ the SNS
3
may contain products that would
otherwise not be available for
widespread distribution. For example,
the ASPR (exercising the Secretary’s
authority), in collaboration with the
Director of the CDC and in coordination
with the Department of Homeland
Security, may determine that it is
appropriate to include certain
investigational medical products in the
SNS. As described in section II of this
document, some of these products
require storage at extremely low
temperatures and cannot be temporarily
removed from storage for relabeling
without compromising their integrity.
Moreover, shipping products from SNS
storage sites to relabelers or back to
manufacturers for relabeling could
increase the potential for sabotage and
diversion, as well as increase exposure
to conditions affecting product quality,
such as temperature deviations. As a
result, removing these investigational
products from storage for relabeling at
the time of approval and then returning
them to storage could undermine their
safety, effectiveness, or availability and,
in some cases, would be impracticable.
Compliance with the FDA regulations
that would require such relabeling
could discourage SNS procurement of
these products and thereby limit
available countermeasures in the event
of a bioterrorist attack or other public
health emergency.
To address this concern, FDA is
creating a mechanism to allow
exceptions or alternatives to the labeling
regulations specified in this rule to help
ensure the safety, effectiveness, and
availability of medical products that are
or will be included in the SNS. FDA has
concluded that exceptions or
alternatives granted under this rule will
not render products misbranded due to
the additional safeguards and
conditions that may be required when
an exception or alternative is granted, as
well as the unique storage, deployment,
and distribution considerations
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essential to the SNS. As explained in
section III.D of this document, a grant of
an exception or alternative under this
rule may include additional safeguards
or conditions so that the labeling of
products subject to the exception or
alternative includes information needed
for safe and effective use under the
anticipated circumstances of use.
Moreover, products intended for use in
certain public health emergencies are
likely to be administered to large
numbers of people within confined
geographic areas, such as in the case of
a natural disaster. These SNS products
may therefore be packaged in large
quantities to facilitate rapid distribution
on extremely short notice.
Consequently, their packaging and
distribution may differ from that of non-
SNS products. Moreover, HHS may
establish special mechanisms to provide
product information, collect adverse
event information, and track the
product’s distribution.
This rule does not create exemptions
from express statutory requirements or
prohibitions regarding medical product
labeling. The FFD&C Act and the PHS
Act set forth certain types of
information that must appear in the
labeling for medical products. For
example, section 351(a)(1)(B) of the PHS
Act provides that each package of a
biological product must be marked with
the proper name of the biological
product; the name, address, and
applicable license number of the
manufacturer of the biological product;
and the expiration date of the biological
product. Drugs (including biological
products) and medical devices in
package form must bear labels
containing the name and place of
business of the manufacturer, packer, or
distributor (section 502(b)(1) of the
FFD&C Act). This interim final rule does
not permit exceptions or alternatives to
any of those requirements. In addition,
the FFD&C Act and the PHS Act both
prohibit false labeling (section 502(a) of
the FFD&C Act); section 351(b) of the
PHS Act). This interim final rule does
not allow false information to appear in
medical product labeling.
As noted previously, this rule does
not limit FDA’s ability to exercise
enforcement discretion with respect to
statutory and regulatory requirements,
including those involving medical
product labeling (
see Heckler
v.
Chaney
,
470 U.S. 821 (1985)).
To the extent that a State requires
labeling that directly conflicts with, is
different from, or is in addition, to any
exceptions or alternatives granted under
this rule, the State-required labeling
would be subject to implied conflict
preemption and, in some cases, express
preemption. FDA restated its
longstanding views on preemption in
the preamble to the recently
promulgated final rule entitled
‘‘Requirements on Content and Format
of Labeling for Human Prescription
Drug and Biological Products’’ (see 71
FR 3922 at 3933 through 3936 and 3967
through 3969; January 24, 2006), and
that discussion reflects the agency’s
current position on this issue.
Under the principles of implied
conflict preemption, courts have found
State law preempted where it is
impossible to comply with both Federal
and State law or where the State law
‘‘stands as an obstacle to the
accomplishment and execution of the
full purposes and objectives of
Congress.’’
See English
v.
General
Electric Co.
, 496 U.S. 72, 79 (1990);
Florida Lime & Avocado Growers, Inc.
,
373 U.S. 132, 142–143 (1963);
Hines
v.
Davidowitz
, 312 U.S. 52, 67 (1941).
Consistent with this case law, section
4(a) of Executive Order 13132 states that
‘‘[a]gencies shall construe * * * a
Federal statute to preempt State law
only where the statute contains an
express preemption provision or there is
some other clear evidence that the
Congress intended preemption of State
law, or where the exercise of State
authority conflicts with the exercise of
Federal authority under the Federal
statute.’’
As explained previously, this interim
final rule will facilitate the safety,
effectiveness, and availability of
appropriate medical countermeasures in
the event of a public health emergency.
Because Congress authorized the SNS to
‘‘provide for the emergency health
security of the United States * * * in the
event of a bioterrorist attack or other
public health emergency,’’ products
held in the SNS should be ready for
deployment at all times. In an
emergency, it is critical that State
requirements regarding the content and
format of labeling do not interfere with
the safety, effectiveness, or availability
of SNS products. FDA believes that
State-required labeling requirements
different from or in addition to FDA
requirements would ‘‘stand as an
obstacle to the accomplishment and
execution of the full purposes and
objectives of Congress.’’ See Hines, 312
U.S. at 67. Moreover, these State
requirements would ‘‘conflict with the
exercise of Federal authority under
[PHS Act section 319F–2, 42 U.S.C.
247d–6b].’’ See Executive Order 13132.
Additionally, under section 751 of the
FFD&C Act (21 U.S.C. 379r), State or
local requirements that are different
from or in addition to exceptions or
alternatives granted under this rule, and
relate to the regulation of
nonprescription drugs, are expressly
preempted. Similarly, in accordance
with section 521 of the FFD&C Act (21
U.S.C. 360k), State or local requirements
that are different from, or in addition to,
exceptions or alternatives granted under
this rule with respect to approved


[Federal Register Volume 86, Number 32 (Friday, February 19, 2021)]
[Rules and Regulations]
[Pages 10178-10180]
[FR Doc No: 2021-03362]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2020-0146; FRL-10018-54]

Complex Polymeric Polyhydroxy Acids (CPPA); Amendment to the
Exemption From the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation amends the existing tolerance exemption for
residues of Complex Polymeric Polyhydroxy Acids (CPPA) in or on all
food commodities as a plant growth regulator to add use as a nematicide
in pesticide formulations. FBSciences, Inc. submitted a petition to EPA
under the Federal Food, Drug, and Cosmetic Act (FFDCA) requesting this
amendment. This regulation adds use as a nematicide to the existing
tolerance exemption of CPPA under FFDCA.

DATES: This regulation is effective February 19, 2021. Objections and
requests for hearings must be received on or before April 20, 2021, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2020-0146, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>.
    Due to the public health concerns related to COVID-19, the EPA
Docket Center (EPA/DC) and Reading Room is closed to visitors with
limited exceptions. The staff continues to provide remote customer
service via email, phone, and webform. For the latest status
information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Charles Smith, Biopesticides and
Pollution Prevention Division (7511P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; main telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

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

    You may access a frequently updated electronic version of 40 CFR
part 180 through the Government Publishing Office's e-CFR site at
http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

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

    Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file
an objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2020-0146 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing and must be received by the Hearing Clerk on or before
April 20, 2021. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2020-0146, by one of
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, is available at http://www.epa.gov/dockets.

II. Background

    In the Federal Register of May 05, 2020 (85 FR 26684) (FRL-10008-
46), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance
petition (PP 0F8822) by FBSciences, Inc., 153 N. Main Street, Ste. 100,
Collierville, TN 38017-2691. The petition requested that 40 CFR
180.1321 be amended by the addition of use as a nematicide to the
already established exemption from the requirement of a tolerance for
residues of Complex Polymeric Polyhydroxy Acids (CPPA). That document
referenced a summary of the petition prepared by the petitioner
FBSciences, Inc., which is available in the docket for this action at
http://www.regulations.gov. Although comments were received on the
notice of filing, none were relevant to this tolerance rulemaking.
    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement of a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the exemption is ``safe.'' Section 408(c)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is reasonable certainty that no harm will
result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and in residential settings but does not include
occupational exposure. Pursuant to FFDCA section 408(c)(2)(B), in
making a determination to establish or maintain in effect an exemption
from the

requirement of a tolerance, EPA must take into account the factors set
forth in FFDCA section 408(b)(2)(C), which require EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance to ``ensure that there is
a reasonable certainty that no harm will result to infants and children
from aggregate exposure to the pesticide chemical residue. . . .''
Additionally, FFDCA section 408(b)(2)(D) requires that the Agency
consider ``available information concerning the cumulative effects of
such residues and other substances that have a common mechanism of
toxicity. . . .''
    EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. First, EPA determines the
toxicity of pesticides. Second, EPA examines exposure to the pesticide
through food, drinking water, and through other exposures that occur as
a result of pesticide use in residential settings.

II. Toxicological Profile

    Consistent with FFDCA section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action and considered its risk. EPA has also considered available
information concerning the variability of the sensitivities of major
identifiable subgroups of consumers, including infants and children.

A. Overview of Complex Polymeric Polyhydroxy Acids

    Complex Polymeric Polyhydroxy Acids (CPPA) is a complex mixture of
naturally occurring organic substances found in dead plant materials.
The components of CPPA are widespread in nature, being found in soils
and fresh and saltwater environments as a result of decaying plant
materials and are used to condition agricultural soils. Its major
components are humic acid, fulvic acid, and tannins, and their relative
concentrations in soil and water systems are influenced by
environmental conditions, such as climate, soil types, vegetation, and
hydrology. CPPA is made by concentrating the organic substances from
water leached through forest soil using a proprietary manufacturing
process.

B. Biochemical Pesticide Toxicology Data Requirements

    All applicable mammalian toxicology data requirements supporting
the existing tolerance exemption for residues of CPPA in or on all food
commodities as a plant growth regulator have been fulfilled. The
mammalian toxicology data requirements supporting the addition of
nematicide use to the existing tolerance exemption have also been
fulfilled as EPA has relied upon the same mammalian toxicology data
that supported the existing tolerance exemption for CPPA. No acute,
subchronic, or chronic toxicity endpoints were identified in guideline
studies or in data obtained from open technical literature. Moreover,
CPPA is not a mutagen, and is not a developmental toxicant. There are
no known effects on endocrine systems via oral, dermal, or inhalation
exposure. A more in-depth synopsis of the data upon which EPA relied
and its human health risk assessment based on that data can be found in
the document ``Biopesticides Registration Action Document, Complex
Polymeric Polyhydroxy Acids (CPPA),'' which is available in Docket
Number EPA-HQ-OPP-2009-0917-0011, as well as the docket for this
action, via www.regulations.gov as described under ADDRESSES.

IV. Aggregate Exposures

    In examining aggregate exposure, FFDCA section 408 directs EPA to
consider available information concerning exposures from the pesticide
residue in food and all other non-occupational exposures, including
drinking water from ground water or surface water and exposure through
pesticide use in gardens, lawns, or buildings (residential and other
indoor uses).

A. Dietary Exposure

    The proposed use pattern may result in dietary exposure with
possible residues in or on agricultural commodities. No significant
exposure via drinking water is expected beyond what is already present,
when CPPA is used according to the product label directions, because
the active ingredient biodegrades rapidly (half-life = 25.7 days) in
the environment, is applied at low application rates, and is not
directly applied to water. Should exposure occur, however, minimal to
no risk is expected for the general population, including infants and
children, due to low toxicity of CPPA and its components as
demonstrated in the data submitted and evaluated by the Agency. In
addition, the lack of reported incidents in spite of the exposure from
use in commercial agriculture for years to condition soils and its
abundance in nature support a conclusion that minimal to no risk is
expected.

B. Other Non-Occupational Exposure

    Non-occupational exposure is not expected because CPPA will be
applied as a plant growth regulator and nematicide for agricultural
purposes only and there are no residential uses.

V. Cumulative Effects From Substances With a Common Mechanism of
Toxicity

    Section 408(b)(2)(D)(v) of FFDCA requires that, in establishing a
tolerance or tolerance exemption for a pesticide chemical residue, the
Agency consider ``available information concerning the cumulative
effects of such residues and other substances that have a common
mechanism of toxicity. . . .'' EPA has determined CPPA to have a non-
toxic mode of action; therefore, 408(b)(2)(D)(v) does not apply.

VI. Determination of Safety for U.S. Population, Infants and Children

    FFDCA section 408(b)(2)(C) provides that, in establishing a
tolerance or tolerance exemption for a pesticide chemical residue, EPA
shall assess the available information about consumption patterns among
infants and children, special susceptibility of infants and children to
pesticide chemical residues, and the cumulative effects on infants and
children of the residues and other substances with a common mechanism
of toxicity. In addition, FFDCA section 408(b)(2)(C) provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure, unless EPA determines that a different margin of safety
will be safe for infants and children. This additional margin of safety
is commonly referred to as the Food Quality Protection Act Safety
Factor. In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data are available to support the choice of a different safety
factor. As part of its qualitative assessment, EPA evaluated the
available toxicity and exposure data on CPPA and considered its
validity, completeness, and reliability, as well as the relationship of
this information to human risk. EPA considers the toxicity database to
be complete and has identified no residual uncertainty with regard to
prenatal and postnatal toxicity or exposure. No hazard was identified
based on the available studies. Based upon its evaluation, EPA
concludes that there are no threshold effects of concern to infants,
children, or adults when CPPA

is applied as a plant growth regulator or nematicide and used in
accordance with label directions and good agricultural practices. As a
result, EPA concludes that no additional margin of exposure (safety) is
necessary.

VII. Other Considerations

A. Analytical Enforcement Methodology

    An analytical method is not required for Complex Polymeric
Polyhydroxy Acids (CPPA) because EPA is amending an exemption from the
requirement of a tolerance without any numerical limitation.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). Codex is a joint United Nations Food and Agriculture
Organization/World Health Organization food standards program, and it
is recognized as an international food safety standards-setting
organization in trade agreements to which the United States is a party.
EPA may establish a tolerance that is different from a Codex MRL;
however, FFDCA section 408(b)(4) requires that EPA explain the reasons
for departing from the Codex level. The Codex has not established an
MRL for CPPA.

VIII. Conclusion

    EPA concludes that there is a reasonable certainty that no harm
will result to the U.S. population, including infants and children,
from aggregate exposure to residues of CPPA. Therefore, EPA is
establishing an exemption from the requirement of a tolerance for
residues of CPPA in or on all food commodities when applied as a
nematicide and used in accordance with good agricultural practices.

IX. Statutory and Executive Order Reviews

    This action establishes a tolerance exemption under FFDCA section
408(d) in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997), nor is it considered a
regulatory action under Executive Order 13771, entitled ``Reducing
Regulations and Controlling Regulatory Costs'' (82 FR 9339, February 3,
2017). This action does not contain any information collections subject
to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501
et seq., nor does it require any special considerations under Executive
Order 12898, entitled ``Federal Actions to Address Environmental
Justice in Minority Populations and Low-Income Populations'' (59 FR
7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance
exemption in this final rule, do not require the issuance of a proposed
rule, the requirements of the Regulatory Flexibility Act (RFA) (5
U.S.C. 601 et seq.), do not apply.
    This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.). This action does not involve any
technical standards that would require Agency consideration of
voluntary consensus standards pursuant to section 12(d) of the National
Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note).

X. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

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

    Dated: February 16, 2021.
Charles Smith,
Acting Director, Biopesticides and Pollution Prevention Division,
Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES
IN FOOD

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

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

0
2. Revise Sec.  180.1321 to read as follows:

Sec.  180.1321  Complex Polymeric Polyhydroxy Acids; exemption from the
requirement of a tolerance.

    (a) An exemption from the requirement of a tolerance is established
for the residues of complex polymeric polyhydroxy acids in or on all
food commodities when applied as a plant growth regulator and used in
accordance with good agricultural practices.
    (b) An exemption from the requirement of a tolerance is established
for the residues of complex polymeric polyhydroxy acids in or on all
food commodities when applied as a nematicide and used in accordance
with good agricultural practices.

[FR Doc. 2021-03362 Filed 2-18-21; 8:45 am]
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[Federal Register Volume 81, Number 154 (Wednesday, August 10, 2016)]
[Notices]
[Pages 52955-52956]
[FR Doc No: 2016-19010]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket No. FRA-2000-7257, Notice No. 82]

Railroad Safety Advisory Committee; Notice of Meeting

AGENCY: Federal Railroad Administration (FRA), Department of
Transportation.

ACTION: Announcement of Railroad Safety Advisory Committee (RSAC)
meeting.

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SUMMARY: FRA announces the fifty-sixth meeting of the RSAC, a Federal
Advisory Committee that develops railroad safety regulations through a
consensus process. The RSAC meeting topics will include opening remarks
from the FRA Administrator and the Associate Administrator for Railroad
Safety and Chief Safety Officer. The Remote Control Locomotive, Track
Standards, Hazardous Materials Issues, and Rail Integrity Working
Groups, and Engineering Task Force will provide status reports.
Informational presentations will be provided on the high-speed
passenger rail equipment (Tier III) rulemaking; the System Safety Plan
rulemaking; the status of Positive Train Control implementation; the
Maintenance-of-Way, Drug and Alcohol, and Roadway Worker Protection
final rules; and the potential certification of dispatchers and signal
maintainers. This agenda is subject to change, including the adding
more proposed tasks.

DATES: The RSAC meeting is scheduled to commence at 9:30 a.m. on
Thursday, September 15, 2016, and will adjourn by 4:30 p.m.

ADDRESSES: The RSAC meeting will be held at the National Association of
Home Builders, National Housing Center, located at 1201 15th Street
NW., Washington, DC 20005. The meeting is open to the public on a
first-come, first-served basis, and is accessible to individuals with
disabilities. Sign and oral interpretation can be made available if
requested 10 calendar days before the meeting.

FOR FURTHER INFORMATION CONTACT: Kenton Kilgore, RSAC Administrative
Officer/Coordinator, FRA, 1200 New Jersey Avenue SE., Mailstop 25,
Washington, DC 20590,<PHONE_NUMBER>; or Robert Lauby, Associate
Administrator for Railroad Safety and Chief Safety Officer, FRA, 1200
New Jersey Avenue SE., Mailstop 25, Washington, DC 20590, (202) 493-
6474.

SUPPLEMENTARY INFORMATION: Under Section 10(a)(2) of the Federal
Advisory Committee Act (Pub. L. 92-463), FRA is giving notice of a
meeting of the RSAC. The RSAC was established to provide advice and
recommendations to FRA on railroad safety matters. The RSAC is composed
of 59 voting representatives from 38 member organizations, representing
various rail industry perspectives. In addition, there are non-voting
advisory representatives from the agencies with railroad safety
regulatory responsibility in Canada and Mexico, the National
Transportation Safety Board, and the Federal Transit Administration.
The diversity of the RSAC ensures the requisite range of views and
expertise necessary to discharge its responsibilities. See the RSAC Web
site for details on prior RSAC activities and pending tasks at http://rsac.fra.dot.gov/. Please refer to the notice published in the Federal

Register on March 11, 1996 (61 FR 9740), for additional information
about the RSAC.

    Issued in Washington, DC, on August 2, 2016.
Robert C. Lauby,
Associate Administrator for Railroad Safety, Chief Safety Officer.
[FR Doc. 2016-19010 Filed 8-9-16; 8:45 am]
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