[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: 
<a href="/cdn-cgi/l/email-protection#137e60677675727d5372637b7a603d666077723d747c65"><span class="__cf_email__" data-cfemail="b4d9c7c0d1d2d5daf4d5c4dcddc79ac1c7d0d59ad3dbc2">[email protected]</span></a>.

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

[[Page 47554]]

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

[[Page 47555]]

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

[[Page 47557]]

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; 
<SUP>8</SUP>
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    \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.<SUP>9</SUP>
---------------------------------------------------------------------------

    \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.<SUP>10</SUP>
---------------------------------------------------------------------------

    \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).<SUP>11</SUP>
---------------------------------------------------------------------------

    \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.<SUP>12</SUP>
---------------------------------------------------------------------------

    \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.

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[[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


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