Mediterranean Fruit Fly; Additions to Quarantined Areas and Treatments

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:

[email protected].

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

[[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

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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

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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