97-23948. Mediterranean Fruit Fly; Additions to Quarantined Areas and Treatments  

  • [Federal Register Volume 62, Number 175 (Wednesday, September 10, 1997)]
    [Rules and Regulations]
    [Pages 47553-47558]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 97-23948]
    
    
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    DEPARTMENT OF AGRICULTURE
    
    Animal and Plant Health Inspection Service
    
    7 CFR Part 301
    
    [Docket No. 97-056-5]
    
    
    Mediterranean Fruit Fly; Additions to Quarantined Areas and 
    Treatments
    
    AGENCY: Animal and Plant Health Inspection Service, USDA.
    
    ACTION: Interim rule and request for comments.
    
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    SUMMARY: We are amending the Mediterranean fruit fly regulations by 
    adding a portion of Sarasota County, FL, to the list of quarantined 
    areas and by expanding the boundaries of the quarantined area in Polk 
    County, FL, due to the detection of Mediterranean fruit fly 
    infestations in those new areas. This action is necessary on an 
    emergency basis to prevent the spread of the Mediterranean fruit fly 
    into noninfested areas of the United States. We are also amending the 
    regulations to provide for the use of irradiation as a treatment for 
    berries, fruits, nuts, and vegetables that are regulated articles. This 
    action will provide an additional option for qualifying those regulated 
    articles for movement from quarantined areas.
    
    DATES: This interim rule is effective September 4, 1997. Consideration 
    will be given only to comments received on or before November 10, 1997.
    
    ADDRESSES: Please send an original and three copies of your comments to 
    Docket No. 97-056-5, Regulatory Analysis and Development, PPD, APHIS, 
    suite 3C03, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please 
    state that your comments refer to Docket No. 97-056-5. Comments 
    received may be inspected at USDA, room 1141, South Building, 14th 
    Street and Independence Avenue SW., Washington, DC, between 8 a.m. and 
    4:30 p.m., Monday through Friday, except holidays. Persons wishing to 
    inspect comments are requested to call ahead on (202) 690-2817 to 
    facilitate entry into the comment reading room.
    
    FOR FURTHER INFORMATION CONTACT: Mr. Michael B. Stefan, Operations 
    Officer, Domestic and Emergency Programs, PPQ, APHIS, 4700 River Road 
    Unit 134, Riverdale, MD 20737-1236, (301) 734-8247; or e-mail: 
    mstefan@aphis.usda.gov.
    
    SUPPLEMENTARY INFORMATION:
    
    Background
    
        The Mediterranean fruit fly, Ceratitis capitata (Wiedemann), is one 
    of the world's most destructive pests of numerous fruits and 
    vegetables. The Mediterranean fruit fly (Medfly) can cause serious 
    economic losses. Heavy infestations can cause complete loss of crops, 
    and losses of 25 to 50 percent are not uncommon. The short life cycle 
    of this pest permits the rapid development of serious outbreaks.
        The Mediterranean fruit fly regulations (7 CFR 301.78 through 
    301.78-10, referred to below as the regulations) restrict the 
    interstate movement of regulated articles from quarantined areas to 
    prevent the spread of Medfly to noninfested areas of the United States.
        In an interim rule effective on June 16, 1997, and published in the 
    Federal Register on June 20, 1997 (62 FR 33537-33539, Docket No. 97-
    056-2), we added a portion of Hillsborough County, FL, to the list of 
    quarantined areas and restricted the interstate movement of regulated 
    articles from that quarantined area, and added eggplant, other than 
    commercially produced eggplant, to the list of regulated articles. In a 
    second interim rule effective on July 3, 1997, and published in the 
    Federal Register on July 10, 1997 (62 FR 36976-36978, Docket No. 97-
    056-3), we expanded the quarantined area in Hillsborough County, FL, 
    and added areas in Manatee and Polk Counties, FL, to the list of 
    quarantined areas. In a third interim rule effective on August 7, 1997, 
    and published in the Federal Register on August 13, 1997 (62 FR 43269-
    43272, Docket No. 97-056-4), we further expanded the quarantined area 
    by adding new areas of Hillsborough County, FL, and an area in Orange 
    County, FL, to the list of quarantined areas. In that third interim 
    rule, we also revised the entry for Manatee County, FL, to make the 
    boundary lines of the quarantined area more accurate.
        Recent trapping surveys by inspectors of Florida State and county 
    agencies and by inspectors of the Animal and Plant Health Inspection 
    Service (APHIS) have revealed that infestations of Medfly have occurred 
    in an additional area in Polk County and in a portion of Sarasota 
    County, FL.
        The regulations in Sec. 301.78-3 provide that the Administrator of 
    APHIS will list as a quarantined area each State, or each portion of a 
    State, in which the Medfly has been found by an inspector, in which the 
    Administrator has reason to believe that the Medfly is present, or that 
    the Administrator considers necessary to regulate because of its 
    inseparability for quarantine enforcement purposes from localities in 
    which the Medfly has been found.
        Less than an entire State will be designated as a quarantined area 
    only if the Administrator determines that the State has adopted and is 
    enforcing restrictions on the intrastate movement of the regulated 
    articles that are equivalent to those imposed on the interstate 
    movement of regulated articles, and the designation of less than the 
    entire State as a quarantined area will prevent the interstate spread 
    of the Medfly. The boundary lines for a portion of a State being 
    designated as quarantined are set up approximately 4.5 miles from the 
    detection sites. The boundary lines may vary due to factors such as the 
    location of Medfly host material, the location of transportation 
    centers such as bus stations and airports, the pattern of persons 
    moving in that State, the number and patterns of distribution of the 
    Medfly, and the use of clearly identifiable lines for the boundaries.
        In accordance with those criteria and the recent Medfly findings 
    described above, we are quarantining a new area in Polk County, FL, and 
    an area in Sarasota County, FL. Those new areas are included in the 
    description of quarantined areas contained in Sec. 301.78-3 in the rule 
    portion of this document. We have also changed the manner in which the 
    previously quarantined areas in Hillsborough and Polk Counties are 
    described. Those areas had been described in two entries, one for 
    ``Hillsborough County'' and one for ``Hillsborough and Polk Counties.'' 
    The joint ``Hillsborough and Polk Counties'' entry has been eliminated 
    and the quarantined areas that had been described in that entry have 
    been incorporated into the appropriate entry for Hillsborough County or 
    Polk County.
    
    Irradiation Treatment
    
        We are also amending the Medfly regulations to include irradiation 
    as a treatment for those berries, fruits, nuts, and vegetables that are 
    listed as regulated articles in Sec. 301.78-2(a) of the regulations. 
    Without irradiation, the only treatments made available by the 
    regulations have been vapor heat for bell peppers, fumigation or vapor 
    heat for tomatoes, and fumigation, fumigation
    
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    plus refrigeration, or cold treatment for regulated citrus fruit that 
    has been harvested. The addition of irradiation provides a treatment 
    option for use on those commodities as well as all other regulated 
    berries, fruits, nuts, and vegetables grown in a quarantined area.
        To accommodate the inclusion of irradiation as an authorized 
    treatment under the Medfly regulations, we are amending Sec. 301.78-10, 
    ``Treatments,'' by redesignating paragraphs (c) and (d) of that 
    section, which pertain to treating premises and soil, respectively, as 
    paragraphs (d) and (e), and adding the irradiation provisions as a new 
    paragraph (c).
        The provisions we are adding to the Medfly regulations for the use 
    of irradiation as a treatment are, for all practical purposes, the same 
    as those provided in Sec. 318.13-4f of ``Subpart--Hawaiian Fruits and 
    Vegetables'' (7 CFR 318.13 through 318.13-17), which provides for the 
    use of irradiation as a treatment for carambola, litchi, and papaya 
    grown in Hawaii. The irradiation provisions we have added to the Medfly 
    regulations differ from those of Sec. 318.13-4f in only three 
    substantive respects: (1) The number of commodities and pests for which 
    irradiation is an approved treatment, (2) the prescribed irradiation 
    dose rate, and (3) the location of approved facilities and the 
    conditions governing the interstate movement of treated and untreated 
    commodities. These three differences are discussed below.
        With respect to the first difference cited above--the number of 
    commodities and pests for which the Medlfy regulations authorize 
    irradiation as a treatment--the irradiation provisions of the Medlfy 
    regulations expand the number of commodities from the 3 listed in 
    Sec. 318.13-4f (i.e., carambola, litchi, and papaya) to the 54 berries, 
    fruits, nuts, and vegetables listed as regulated articles in 
    Sec. 301.78-2(a). As discussed above, the Medlfy regulations did not 
    provide treatments for commodities other than bell pepper, tomato, and 
    harvested citrus fruit. As noted in APHIS' policy statement regarding 
    the application of irradiation to phytosanitary problems (published in 
    the Federal Register on May 15, 1996, 61 FR 24433-24439, Docket No. 95-
    088-1), the U.S. Department of Agriculture's (USDA's) Agricultural 
    Research Service (ARS) conducted exhaustive research to determine 
    commodity-generic irradiation dose rates that will provide an 
    acceptable level of quarantine security with regard to certain pests. 
    Given that a commodity-generic dose rate has been established for 
    Medfly, we believe that it is appropriate to provide the prescribed 
    irradiation treatment as an option for growers of any of the 54 
    different berries, fruits, nuts, and vegetables listed as regulated 
    articles who wish to obtain certification for the interstate movement 
    of their commodities on the basis of treatment.
        The second difference cited above pertains to the prescribed 
    irradiation dose rate. The commodity-generic dose rate established by 
    ARS for Medfly is 225 Gray (22.5 krad), so we have established 225 Gray 
    as the prescribed dose rate in the Medfly regulations, rather than the 
    250 Gray (25 krad) prescribed in Sec. 318.13-4f of ``Subpart--Hawaiian 
    Fruits and Vegetables.'' Although Medlfy is among the pests of concern 
    in Hawaii, the focus of the treatments in Sec. 318.13-4f is on what is 
    referred to as the ``Trifly complex,'' which consists of Medfly, 
    Oriental fruit fly (Bactrocera dorsalis), and the melon fly (Bactrocera 
    cucurbitae). Of the three, the Oriental fruit fly is the species most 
    resistant to irradiation, requiring a dose rate of 250 Gray, so it was 
    necessary for the irradiation protocol prescribed in Sec. 318.13-4f to 
    require that higher dose rate in order to provide quarantine security 
    against all three pests of the Trifly complex. Because the Oriental 
    fruit fly is not a pest of concern in the Medfly regulations, we have 
    set 225 Gray as the prescribed dose rate in Sec. 301.78-10.
        The third and final difference cited above pertains to the location 
    of approved facilities and the conditions governing the interstate 
    movement of treated and untreated commodities. Section 318.13-4f of 
    ``Subpart--Hawaiian Fruits and Vegetables'' provides for interstate 
    movement of carambola, litchi, and papaya from Hawaii and the 
    application of irradiation treatment either in Hawaii or, under certain 
    conditions, at approved facilities on the mainland. Those provisions 
    relate to treatment in Hawaii, the movement of treated and untreated 
    fruits and vegetables to the mainland, and restrictions on the mainland 
    States where an approved facility for the treatment of carambola, 
    litchi, and papaya from Hawaii may be located, as well as a prohibition 
    against the movement of litchi into Florida. The regulations pertaining 
    to the location of approved facilities in Hawaii and the mainland, as 
    well as the restrictions on the movement of litchi, are not relevant to 
    the Medlfy regulations and were, therefore, not included. Further, in 
    adding irradiation as a treatment in the Medfly regulations, we did not 
    believe it was necessary to include similar interstate movement 
    conditions in the section describing the treatment (Sec. 301.78-10) 
    because the Medlfy regulations in Sec. 301.78-4 already address the 
    conditions governing the interstate movement of regulated articles from 
    a quarantined area, including regulated articles that have been treated 
    in accordance with Sec. 301.78-10.
        The remaining provisions of Sec. 318.13-4f of ``Subpart--Hawaiian 
    Fruits and Vegetables''--i.e., those provisions regarding approved 
    facilities, treatment monitoring, packaging, dosimetry systems, 
    certification based on treatment, recordkeeping, requests for approval 
    and inspection of facilities, denial and withdrawal of approval, and 
    the USDA's non-responsibility for loss or damage resulting from 
    treatment--have been reproduced in the Medfly regulations and serve the 
    same purpose as in Sec. 318.13-4f.
    
    Miscellaneous
    
        We have amended the introductory text of Sec. 310.78-10 to remove 
    an outdated reference to the kinds of regulated articles for which 
    treatments are provided in that section. The last sentence of that 
    introductory text, which stated ``The following treatment may be used 
    for bell pepper, tomato, and soil,'' should have been updated 
    previously to reflect the inclusion in the regulations of treatments 
    for regulated citrus fruit that has been harvested and for premises 
    within a quarantined area. To correct that omission, and to reflect the 
    inclusion of the irradiation treatments discussed above, we have 
    changed that final sentence to read ``The following treatments may be 
    used for the regulated articles indicated.''
        We have amended Sec. 301.78-1 to add a definition of the term 
    ``core area.'' That term is used in Sec. 301.78-10 with regard to the 
    treatment of premises in a quarantined area, but is not defined. We 
    have defined ``core area'' as ``The 1 square mile area surrounding each 
    property where Mediterranean fruit fly has been detected.'' Except for 
    the specific reference to Medfly, the definition is the same as the 
    definition provided for the same term in our domestic quarantine 
    regulations for Mexican fruit fly (7 CFR 301.64 through 301.64-10) and 
    Oriental fruit fly (7 CFR 301.93 through 301.93-10). We have also made 
    a minor editorial correction in two places in the regulations.
    
    Emergency Action
    
        The Administrator of the Animal and Plant Health Inspection Service 
    has determined that an emergency exists that warrants publication of 
    this interim rule without prior opportunity for
    
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    public comment. Immediate action is necessary to prevent the Medfly 
    from spreading to noninfested areas of the United States.
        Because prior notice and other public procedures with respect to 
    this action are impracticable and contrary to the public interest under 
    these conditions, we find good cause under 5 U.S.C. 553 to make it 
    effective upon signature. We will consider comments that are received 
    within 60 days of publication of this rule in the Federal Register. 
    After the comment period closes, we will publish another document in 
    the Federal Register. It will include a discussion of any comments we 
    receive and any amendments we are making to the rule as a result of the 
    comments.
    
    Executive Order 12866 and Regulatory Flexibility Act
    
        This rule has been reviewed under Executive Order 12866. For this 
    action, the Office of Management and Budget has waived its review 
    process required by Executive Order 12866.
        This interim rule amends the Medfly regulations by adding a portion 
    of Sarasota County, FL, to the list of quarantined areas and by 
    expanding the boundaries of the quarantined area in Polk County, FL, 
    due to the detection of Mediterranean fruit fly infestations in those 
    new areas. This action is necessary on an emergency basis to prevent 
    the spread of the Mediterranean fruit fly into noninfested areas of the 
    United States. This interim rule also amends the regulations to provide 
    for the use of irradiation as a treatment for berries, fruits, nuts, 
    and vegetables that are regulated articles. This action will provide an 
    additional option for qualifying those regulated articles for movement 
    from quarantined areas.
        This interim rule is the fourth in a series of interim rules that 
    have designated certain areas of Florida as quarantined areas for 
    Medfly. The three previous interim rules were published in the Federal 
    Register on June 20, 1997 (62 FR 33537-33539, Docket No. 97-056-2), 
    July 10, 1997 (62 FR 36976-36978, Docket No. 97-056-3), and August 13, 
    1997 (62 FR 43269-43272, Docket No. 97-056-4). In each of those interim 
    rules, we stated that the emergency situation with respect to Medfly 
    made compliance with section 603 and timely compliance with section 604 
    of the Regulatory Flexibility Act (5 U.S.C. 601 et seq.) impracticable. 
    We further stated that, if we determined that those rules would have a 
    significant economic impact on a substantial number of small entities, 
    we would discuss the issues raised by section 604 of the Regulatory 
    Flexibility Act in our Final Regulatory Flexibility Analysis. For this 
    interim rule, we have prepared a regulatory flexibility analysis that 
    examines the potential economic impacts on small entities of this 
    interim rule, as well as of the three previous interim rules.
        We estimate that there are 1,062 entities in the quarantined areas 
    of Hillsborough, Manatee, Polk, Orange, and Sarasota Counties that 
    sell, process, handle, or move regulated articles; that estimate 
    considers 13 transportation terminals, 295 fruit stands, 64 flea 
    markets, 4 processing plants, 64 farmers markets, 189 nurseries 
    (primarily retail), 149 mobile produce vendors, 256 food stores, 2 
    fruit shippers, 3 commercial growers, 21 garbage service firms, 1 
    vegetable packinghouse, and 1 hauler/harvester. The number of these 
    entities that meet the U.S. Small Business Administration's (SBA's) 
    definition of a small entity is unknown, since the information needed 
    to make that determination (i.e., each entity's gross receipts or 
    number of employees) is not currently available. However, it is 
    reasonable to assume that most of the 1,062 entities are small in size, 
    since the overwhelming majority of businesses in central Florida, as 
    well as the rest of the United States, are small entities by SBA 
    standards. As an example, there were 1,099 grocery stores in the Tampa 
    metropolitan area in 1992. The per-store average sales for all 1,099 
    stores was $2.9 million, well below the SBA's current small entity size 
    standard of $20.0 million for those types of stores. Similarly, the 
    1992 per-store average sales for all 115 retail nursery and lawn and 
    garden supply stores in the Tampa metropolitan area was $0.5 million, 
    well below the SBA's current small entity size standard of $5.0 million 
    for those types of stores.
        Few, if any, of the 1,062 entities will be significantly affected 
    by the quarantine actions taken in the four interim rules because 
    virtually all of those entities do not typically move regulated 
    articles outside the State of Florida during the normal course of their 
    business. Nor do consumers of products purchased from those entities 
    generally move those products interstate. Fruit stands, flea markets, 
    farmers markets, retail nurseries, mobile produce vendors, and food 
    stores comprise, on a combined basis, 1,017 (or about 96 percent) of 
    the 1,062 entities in the quarantined area that sell or handle 
    regulated articles, and the operations of those entities are 
    essentially local in nature. The fruits and vegetables sold by grocery 
    stores and other retail food outlets are generally sold locally for 
    local consumption. Retail nurseries also market their products locally, 
    for local consumption. The interim rules, because they restrict the 
    interstate movement of regulated articles, will have little or no 
    impact on the vast majority of entities in the quarantined area.
        The 12 transportation terminals, 4 processing plants, and 2 fruit 
    shippers comprise the remaining 4 percent of the 1,062 entities in the 
    quarantined area who sell or handle regulated articles. The processors 
    will be largely unaffected by the rule change because any regulated 
    articles they might use are typically used to produce fruit juices and 
    fruit parts, products that are not regulated articles and, as a 
    consequence, are not restricted as to their interstate movement. The 
    transportation terminals are comprised primarily of airports and 
    distribution centers such as U.S. Postal Service facilities and package 
    delivery centers. Most of the terminals derive the bulk of their 
    revenues from activities other than the interstate movement of 
    regulated articles, so the impact of the interim rules on them should 
    be minimal. The two fruit shippers have the potential to be 
    significantly affected, since they would be expected to generate at 
    least some of their revenues from the interstate shipment of fruit. The 
    commercial growers, garbage service firms, vegetable packinghouse, and 
    hauler/harvester also have the potential to be significantly affected. 
    However, the effect on those few small entities that do move regulated 
    articles interstate from the quarantined areas will be minimized by the 
    availability of various treatments that, in most cases, will allow 
    those small entities to move regulated articles interstate with very 
    little additional cost. Also, many of those small entities sell other 
    items in addition to regulated articles, so the effect, if any, of the 
    interim rules should be minimal.
        Finally, the addition of noncommercial eggplant to the list of 
    articles regulated for the Medfly should have minimal impact on small 
    entities. This is because small entities are comprised primarily of 
    small businesses, and most small businesses in the regulated area sell 
    or handle only commercially produced eggplant.
        Under these circumstances, the Administrator of the Animal and 
    Plant Health Inspection Service has determined that this action will 
    not have a significant economic impact on a substantial number of small 
    entities.
    
    Executive Order 12372
    
        This program/activity is listed in the Catalog of Federal Domestic 
    Assistance
    
    [[Page 47556]]
    
    under No. 10.025 and is subject to Executive Order 12372, which 
    requires intergovernmental consultation with State and local officials. 
    (See 7 CFR part 3015, subpart V).
    
    Executive Order 12988
    
        This rule has been reviewed under Executive Order 12988, Civil 
    Justice Reform. This rule: (1) Preempts all State and local laws and 
    regulations that are inconsistent with this rule; (2) has no 
    retroactive effect; and (3) does not require administrative proceedings 
    before parties may file suit in court challenging this rule.
    
    National Environmental Policy Act
    
        An environmental assessment and finding of no significant impact 
    have been prepared for this rule. The site specific environmental 
    assessment and programmatic Medfly environmental impact statement 
    provide a basis for our conclusion that implementation of integrated 
    pest management to achieve eradication of the Medfly would not have a 
    significant impact on human health and the natural environment. Based 
    on the finding of no significant impact, the Administrator of the 
    Animal and Plant Health Inspection Service has determined that an 
    environmental impact statement need not be prepared.
        The environmental assessment and finding of no significant impact 
    were prepared in accordance with: (1) The National Environmental Policy 
    Act of 1969, as amended (NEPA) (42 U.S.C. 4321 et seq.), (2) 
    Regulations of the Council on Environmental Quality for implementing 
    the procedural provisions of NEPA (40 CFR parts 1500-1508), (3) USDA 
    regulations implementing NEPA (7 CFR part 1b), and (4) APHIS' NEPA 
    Implementing Procedures (7 CFR part 372).
        Copies of the environmental assessment and finding of no 
    significant impact are available for public inspection at USDA, room 
    1141, South Building, 14th Street and Independence Avenue SW., 
    Washington, DC, between 8 a.m. and 4:30 p.m., Monday through Friday, 
    except holidays. Persons wishing to inspect copies are requested to 
    call ahead on (202) 690-2817 to facilitate entry into the reading room. 
    In addition, copies may be obtained by writing to the individual listed 
    under FOR FURTHER INFORMATION CONTACT.
    
    Paperwork Reduction Act
    
        This rule contains no information collection or recordkeeping 
    requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 
    et seq.).
    
    List of Subjects in 7 CFR Part 301
    
        Agricultural commodities, Incorporation by reference, Plant 
    diseases and pests, Quarantine, Reporting and recordkeeping 
    requirements, Transportation.
    
        Accordingly, 7 CFR part 301 is amended as follows:
    
    PART 301--DOMESTIC QUARANTINE NOTICES
    
        1. The authority citation for part 301 continues to read as 
    follows:
    
        Authority: 7 U.S.C. 147a, 150bb, 150dd, 150ee, 150ff, 161, 162, 
    and 164-167; 7 CFR 2.22, 2.80, and 371.2(c).
    
        2. In Sec. 301.78-1, the defined term Commercially-produced is 
    revised to read Commercially produced, and a definition of Core area is 
    added, in alphabetical order, to read as follows:
    
    
    Sec. 301.78-1  Definitions.
    
    * * * * *
        Core area. The 1 square mile area surrounding each property where 
    Mediterranean fruit fly has been detected.
    * * * * *
    
    
    Sec. 301.78-2  [Amended]
    
        3. In Sec. 301.78-2, paragraph (a), the entry ``Eggplant (Solanum 
    melongena L.), other than commercially-produced eggplant'' is amended 
    by removing the words ``commercially-produced'' and adding the words 
    ``commercially produced'' in their place.
        4. In Sec. 301.78-3, paragraph (c), the entry for Florida is 
    amended by removing the entry for Hillsborough and Polk Counties, and 
    by revising the entry for Hillsborough County and adding entries for 
    Polk County and Sarasota County to read as follows:
    
    
    Sec. 301.78-3  Quarantined areas.
    
    * * * * *
        (c) * * *
    FLORIDA
        Hillsborough County. Beginning at the intersection of the 
    Hillsborough/Polk County line and the section line dividing secs. 25 
    and 36, T. 27 S., R. 22 E.; then west along the section line dividing 
    secs. 25 and 36, T. 27 S., R. 22 E. to the Hillsborough River; then 
    west along the Hillsborough River to I-75; then north along I-75 to the 
    Hillsborough/Pasco County line; then west along the Hillsborough/Pasco 
    County line to the section line dividing secs. 5 and 6, T. 27 S., R. 18 
    E.; then south along the section line dividing secs. 5 and 6, T. 27 S., 
    R. 18 E., to Veterans Expressway; then south along Veterans Expressway 
    to Erhlich Road; then west along Erhlich Road to Gunn Highway; then 
    north along Gunn Highway to Mobley Road; then west along Mobley Road to 
    Racetrack Road; then south and west along Racetrack Road to the 
    Hillsborough County line; then south along the Hillsborough County line 
    to I-275; then east along I-275 to the westernmost land mass at the 
    eastern end of the Howard Franklin Bridge; then south, east, and north 
    along the shoreline of Old Tampa Bay, Tampa Bay, and Hillsborough Bay 
    (including the Interbay Peninsula, Davis Island, Harbour Island, 
    Hooker's Point, and Port Sutton) to the shoreline of the Alafia River's 
    extension; then east along the shoreline of the Alafia River's 
    extension to U.S. Highway 301; then south along U.S. Highway 301 to 
    Balm-Riverview Road; then south and east along Balm-Riverview Road to 
    Rhodine Road; then east along Rhodine Road to Boyette Road; then south, 
    east, and north along Boyette Road to Dorman Road; then east along 
    Dorman Road to Browning Road; then north along Browning Road to Lithia-
    Pinecrest Road; then east along Lithia-Pinecrest Road to Bryant Road; 
    then north along Bryant Road to the Alafia River; then east along the 
    Alafia River to the North Prong Alafia River; then north and west along 
    the North Prong Alafia River to Poley Creek; then east and north along 
    Poley Creek to Hillsborough County line; then north along the county 
    line to the point of beginning.
        The following portion of Hillsborough County is also a quarantined 
    area: Beginning at the mouth of Cockroach Creek in Cockroach Bay; then 
    south along the shoreline of the Cockroach Creek to Valroy Road; then 
    east along Valroy Road to I-75; then north along I-75 to the Little 
    Manatee River; then east along the shoreline of the Little Manatee 
    River to the section line dividing secs. 26 and 27, T. 32 S., R. 19 E.; 
    then north along the section line dividing secs. 26 and 27, T. 32 S., 
    R. 19 E., to the section line dividing secs. 22 and 23, T. 32 S., R. 19 
    E. (also known as SE. 36th Street); then north along the section line 
    dividing secs. 22 and 23, T. 32 S., R. 19 E., (also known as SE. 36th 
    Street)to the section line dividing secs. 14 and 15, T. 32 S., R. 19 
    E.; then north along the section line dividing secs. 14 and 15, T. 32 
    S., R. 19 E. to I-75; then north along I-75 to NE. 19th Avenue; then 
    west along NE. 19th Avenue to the section line dividing secs. 34 and 
    35, T. 31 S., R. 19 E.; then north along the section line dividing 
    secs. 34 and 35, T. 31 S., R. 19 E., through sections 26 and 27, secs. 
    22 and 23, and secs. 14 and 15, T. 31 S., R. 19 E., to U.S. Highway 41; 
    then
    
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    north along U.S. Highway 41 to Big Bend Road (State Road 672); then 
    west along Big Bend Road (State Road 672) to its end; then west along 
    an imaginary line to the shoreline of Tampa Bay; then south and west 
    along the shoreline of Tampa Bay (including all land masses to the east 
    of Tampa Bay) to the shoreline of Cockroach Bay; then south and east 
    along the shoreline of Cockroach Bay to the point of beginning.
    * * * * *
        Polk County. Beginning at the Hillsborough/Polk County line and 
    Poley Creek; then northeast on Poley Creek to State Highway 60; then 
    east along State Highway 60 until it becomes Van Fleet Drive in the 
    city of Bartow; then east along Van Fleet Drive to its intersection 
    with U.S. Highway 17; then north along U.S. Highway 17 to the section 
    line dividing secs. 27 and 28 of T. 29 S., R. 25 E.; then north along 
    the section line dividing secs. 27 and 28 of T. 29 S., R. 25 E. to 
    Thornhill Road; then north along Thornhill Road to State Highway 540; 
    then west along State Highway 540 to the section line dividing secs. 31 
    and 32 of T. 28 S., R. 25 E; then north on the section line dividing 
    secs. 31 and 32 of T. 28 S., R. 25 E., to the section line dividing 
    secs. 30 and 31 of T. 27 S., R. 25 E.; then west along the section line 
    dividing secs. 30 and 31 of T. 27 S., R. 25 E., to the intersection of 
    I-4 and Highway 582; then southwest along I-4 to the section line 
    dividing secs. 9 and 16, T. 28 S., R. 23 E. (corner of Swindell Road 
    and Sutton Road); then west along the section line dividing secs. 9 and 
    16, T. 28 S., R. 23 E., to the Hillsborough/Polk County line (County 
    Line Road); then south along the county line to the point of beginning.
    * * * * *
        Sarasota County. Beginning at the water's edge of Sarasota Bay and 
    Virginia Drive; then west on Virginia Drive to U.S. Highway 41 (Tamiami 
    Trail); then east across U.S. 41 on Martin Luther King Drive and 27th 
    Street (Highway 683) to Lockwood Ridge Road; then south along Lockwood 
    Ridge Road to 17th Street; then east along 17th Street to Honore 
    Avenue; then south along Honore Avenue to State Highway 780 (Fruitville 
    Road); then east along State Highway 780 to I-75; then south along I-75 
    to State Highway 72 (Clark Road); then west along State Highway 72 to 
    State Highway 773 (Beneva Road); then south along State Highway 773 to 
    U.S. Highway 41 (Tamiami Trail); then south across U.S. Highway 41 
    along Vamo Road to Livingstone Street; then west along Livingstone 
    Street to the water's edge of Little Sarasota Bay; then north along the 
    shoreline to the point of beginning. In addition, all islands and keys 
    of Sarasota County from New Pass south to the point where Turtle Beach 
    Drive meets Midnight Pass Road are part of the area regulated for 
    Medfly in Sarasota County.
        5. In Sec. 301.78-10, in the introductory text of the section, the 
    last sentence is amended by removing the words ``treatment may be used 
    for bell pepper, tomato, and soil'' and by adding in their place the 
    words ``treatments may be used for the regulated articles indicated''.
        6. In Sec. 301.78-10, paragraphs (c) and (d) are redesignated as 
    paragraphs (d) and (e), respectively, and a new paragraph (c) is added 
    to read as follows:
    
    
    Sec. 301.78-10  Treatments.
    
    * * * * *
        (c) Approved irradiation treatment. Irradiation, carried out in 
    accordance with the provisions of this paragraph, is approved as a 
    treatment for any berry, fruit, nut, or vegetable listed as a regulated 
    article in Sec. 301.78-2(a) of this subpart.
        (1) Approved facility. The irradiation treatment facility and 
    treatment protocol must be approved by the Animal and Plant Health 
    Inspection Service. In order to be approved, a facility must:
        (i) Be capable of administering a minimum absorbed ionizing 
    radiation dose of 225 Gray (22.5 krad) to the fruits and vegetables; 
    8
    ---------------------------------------------------------------------------
    
        \8\ The maximum absorbed ionizing radiation dose and the 
    irradiation of food is regulated by the Food and Drug Administration 
    under 21 CFR part 179.
    ---------------------------------------------------------------------------
    
        (ii) Be constructed so as to provide physically separate locations 
    for treated and untreated fruits and vegetables, except that fruits and 
    vegetables traveling by conveyor directly into the irradiation chamber 
    may pass through an area that would otherwise be separated. The 
    locations must be separated by a permanent physical barrier such as a 
    wall or chain link fence 6 or more feet high to prevent transfer of 
    cartons;
        (iii) Complete a compliance agreement with the Animal and Plant 
    Health Inspection Service as provided in Sec. 301.78-6 of this subpart; 
    and
        (iv) Be certified by Plant Protection and Quarantine for initial 
    use and annually for subsequent use. Recertification is required in the 
    event that an increase or decrease in radioisotope or a major 
    modification to equipment that affects the delivered dose. 
    Recertification may be required in cases where a significant variance 
    in dose delivery is indicated.
        (2) Treatment monitoring. Treatment must be carried out under the 
    monitoring of an inspector. This monitoring must include inspection of 
    treatment records and unannounced inspection visits to the facility by 
    an inspector. Facilities that carry out continual irradiation 
    operations must notify an inspector at least 24 hours before the date 
    of operations. Facilities that carry out periodic irradiation 
    operations must notify an inspector of scheduled operations at least 24 
    hours before scheduled operations.9
    ---------------------------------------------------------------------------
    
        \9\ Inspectors are assigned to local offices of the Animal and 
    Plant Health Inspection Service, which are listed in telephone 
    directories.
    ---------------------------------------------------------------------------
    
        (3) Packaging. Fruits and vegetables that are treated within a 
    quarantined area must be packaged in the following manner:
        (i) The cartons must have no openings that will allow the entry of 
    fruit flies and must be sealed with seals that will visually indicate 
    if the cartons have been opened. They may be constructed of any 
    material that prevents the entry of fruit flies and prevents 
    oviposition by fruit flies into the fruit in the carton.10
    ---------------------------------------------------------------------------
    
        \10\ If there is a question as to the adequacy of a carton, send 
    a request for approval of the carton, together with a sample carton, 
    to the Animal and Plant Health Inspection Service, Plant Protection 
    and Quarantine, Phytosanitary Issues Management Team, 4700 River 
    Road Unit 140, Riverdale, Maryland 20737-1236.
    ---------------------------------------------------------------------------
    
        (ii) The pallet-load of cartons must be wrapped before it leaves 
    the irradiation facility in one of the following ways:
        (A) With polyethylene sheet wrap;
        (B) With net wrapping; or
        (C) With strapping so that each carton on an outside row of the 
    pallet load is constrained by a metal or plastic strap.
        (iii) Packaging must be labeled with treatment lot numbers, packing 
    and treatment facility identification and location, and dates of 
    packing and treatment.
        (4) Dosage. The fruits and vegetables must receive a minimum 
    absorbed ionizing radiation dose of 225 Gray (22.5 krad).11
    ---------------------------------------------------------------------------
    
        \11\ See footnote 8.
    ---------------------------------------------------------------------------
    
        (5) Dosimetry systems. (i) Dosimetry must demonstrate that the 
    absorbed dose, including areas of minimum and maximum dose, is mapped, 
    controlled, and recorded.
        (ii) Absorbed dose must be measured using a dosimeter that can 
    accurately measure an absorbed dose of 225 Gray (22.5 krad).
        (iii) The number and placement of dosimeters used must be in 
    accordance with American Society for Testing and Materials (ASTM) 
    standards.12
    ---------------------------------------------------------------------------
    
        \12\ Designation E 1261, ``Standard Guide for Selection and 
    Calibration of Dosimetry Systems for Radiation Processing,'' 
    American Society for Testing and Materials, Annual Book of ASTM 
    Standards.
    
    ---------------------------------------------------------------------------
    
    [[Page 47558]]
    
        (6) Records. Records or invoices for each treated lot must be made 
    available for inspection by an inspector during normal business hours 
    (8 a.m. to 4:30 p.m., Monday through Friday, except holidays). An 
    irradiation processor must maintain records as specified in this 
    section for a period of time that exceeds the shelf life of the 
    irradiated food product by 1 year, and must make these records 
    available for inspection by an inspector. These records must include 
    the lot identification, scheduled process, evidence of compliance with 
    the scheduled process, ionizing energy source, source calibration, 
    dosimetry, dose distribution in the product, and the date of 
    irradiation.
        (7) Request for approval and inspection of facility. Persons 
    requesting approval of an irradiation treatment facility and treatment 
    protocol must submit the request for approval in writing to the Animal 
    and Plant Health Inspection Service, Plant Protection and Quarantine, 
    Oxford Plant Protection Center, 901 Hillsboro St., Oxford, NC 27565. 
    Before the Administrator determines whether an irradiation facility is 
    eligible for approval, an inspector will make a personal inspection of 
    the facility to determine whether it complies with the standards of 
    paragraph (c)(1) of this section.
        (8) Denial and withdrawal of approval. (i) The Administrator will 
    withdraw the approval of any irradiation treatment facility when the 
    irradiation processor requests in writing the withdrawal of approval.
        (ii) The Administrator will deny or withdraw approval of an 
    irradiation treatment facility when any provision of this section is 
    not met. Before withdrawing or denying approval, the Administrator will 
    inform the irradiation processor in writing of the reasons for the 
    proposed action and provide the irradiation processor with an 
    opportunity to respond. The Administrator will give the irradiation 
    processor an opportunity for a hearing regarding any dispute of a 
    material fact, in accordance with rules of practice that will be 
    adopted for the proceeding. However, the Administrator will suspend 
    approval pending final determination in the proceeding, if he or she 
    determines that suspension is necessary to prevent the spread of any 
    dangerous insect infestation. The suspension will be effective upon 
    oral or written notification, whichever is earlier, to the irradiation 
    processor. In the event of oral notification, written confirmation will 
    be given to the irradiation processor within 10 days of the oral 
    notification. The suspension will continue in effect pending completion 
    of the proceeding and any judicial review of the proceeding.
        (9) Department not responsible for damage. This treatment is 
    approved to assure quarantine security against Mediterranean fruit fly. 
    From the literature available, the fruits and vegetables authorized for 
    treatment under this section are believed tolerant to the treatment; 
    however, the facility operator and shipper are responsible for 
    determination of tolerance. The Department of Agriculture and its 
    inspectors assume no responsibility for any loss or damage resulting 
    from any treatment prescribed or supervised. Additionally, the Nuclear 
    Regulatory Commission is responsible for ensuring that irradiation 
    facilities are constructed and operated in a safe manner. Further, the 
    Food and Drug Administration is responsible for ensuring that 
    irradiated foods are safe and wholesome for human consumption.
    * * * * *
        Done in Washington, DC, this 4th day of September 1997.
    Craig A. Reed,
    Acting Administrator, Animal and Plant Health Inspection Service.
    [FR Doc. 97-23948 Filed 9-9-97; 8:45 am]
    BILLING CODE 3410-34-P
    
    
    

Document Information

Effective Date:
9/4/1997
Published:
09/10/1997
Department:
Animal and Plant Health Inspection Service
Entry Type:
Rule
Action:
Interim rule and request for comments.
Document Number:
97-23948
Dates:
This interim rule is effective September 4, 1997. Consideration will be given only to comments received on or before November 10, 1997.
Pages:
47553-47558 (6 pages)
Docket Numbers:
Docket No. 97-056-5
PDF File:
97-23948.pdf
CFR: (6)
7 CFR 301.78-2(a)
7 CFR 301.78-1
7 CFR 301.78-2
7 CFR 301.78-3
7 CFR 301.78-10
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