[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
[[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;
8
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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.
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(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
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\9\ Inspectors are assigned to local offices of the Animal and
Plant Health Inspection Service, which are listed in telephone
directories.
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(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
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\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.
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(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
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\11\ See footnote 8.
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(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
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\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
