Federal Register / Vol. 62, No. 175 / Wednesday, September 10, 1997 / Rules and Regulations 47553

northeast along Gateway Boulevard to

the point of beginning.

Done in Washington, DC, this 4th day of

September 1997.

Craig A. Reed,

Acting Administrator, Animal and Plant

Health Inspection Service.

[FR Doc. 97–23949 Filed 9–9–97; 8:45 am]

BILLING CODE 3410–34–U

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.

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 § 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

§ 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 § 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
47554 Federal Register / Vol. 62, No. 175 / Wednesday, September 10, 1997 / Rules and Regulations

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 § 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 § 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 § 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 § 318.13–4f (i.e.,

carambola, litchi, and papaya) to the 54

berries, fruits, nuts, and vegetables

listed as regulated articles in § 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 § 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 § 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

§ 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

§ 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

(§ 301.78–10) because the Medlfy

regulations in § 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

§ 301.78–10.

The remaining provisions of § 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 § 318.13–4f.

Miscellaneous

We have amended the introductory

text of § 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 § 301.78–1 to add

a definition of the term ‘‘core area.’’

That term is used in § 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
Federal Register / Vol. 62, No. 175 / Wednesday, September 10, 1997 / Rules and Regulations 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
47556 Federal Register / Vol. 62, No. 175 / Wednesday, September 10, 1997 / Rules and Regulations

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 § 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:

§ 301.78–1 Definitions.

* * * * *

Core area. The 1 square mile area

surrounding each property where

Mediterranean fruit fly has been

detected.

* * * * *

§ 301.78–2 [Amended]

3. In § 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 § 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:

§ 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 BalmRiverview 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
Federal Register / Vol. 62, No. 175 / Wednesday, September 10, 1997 / Rules and Regulations 47557

8The maximum absorbed ionizing radiation dose

and the irradiation of food is regulated by the Food

and Drug Administration under 21 CFR part 179.

9 Inspectors are assigned to local offices of the

Animal and Plant Health Inspection Service, which

are listed in telephone directories.

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.

11See footnote 8.

12 Designation E 1261, ‘‘Standard Guide for

Selection and Calibration of Dosimetry Systems for

Continued

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 § 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 § 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:

§ 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 § 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

(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 § 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

(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

(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

(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
47558 Federal Register / Vol. 62, No. 175 / Wednesday, September 10, 1997 / Rules and Regulations

Radiation Processing,’’ American Society for

Testing and Materials, Annual Book of ASTM

Standards.

(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

POSTAL SERVICE

39 CFR Part 20

Implementation of Global Package Link

Service

AGENCY: Postal Service.

ACTION: Interim rules with request for

comments.

SUMMARY: Global Package Link is an

international mail service designed for

companies sending merchandise to

other countries. To implement an

agreement previously entered into with

the postal administration of France, that

country is now being added as a

destination country. This action is

consistent with the Postal Service’s

original plan to add destination

countries as customer needs dictate (59

FR 65961; December 22, 1994). Global

Package Link Service has previously

been made available to Brazil, Canada,

Chile, China, Germany, Japan, Mexico,

Singapore, and the United Kingdom. To

use Global Package Link (GPL) service,

a customer must mail at least 10,000

GPL packages a year and agree to link

its information systems with those of

the Postal Service, so that the Postal

Service can extract certain information

about the contents of the customer’s

packages for customs clearance and

other purposes. Initially, the Postal

Service will offer one Standard delivery

option in France. A second, Premium

Service, is under development and will

be available in the next year. Interim

regulations have been developed, and

are set forth below for comment and

suggested revision prior to adoption in

final form.

DATES: The interim regulations take

effect September 10, 1997. Comments

must be received on or before October

10, 1997.

ADDRESSES: Written comments should

be mailed or delivered to Global

Package Link Service, U.S. Postal

Service, 475 L’Enfant Plaza SW, Room

370 IBU, Washington, DC 20260–6500.

Copies of all written comments will be

available for public inspection and

photocopying at the above address

between 9 a.m. and 4 p.m., Monday

through Friday.

FOR FURTHER INFORMATION CONTACT:

Robert Michelson at the above address.

Telephone: (202) 268–5731.

SUPPLEMENTARY INFORMATION:

I. Introduction

One of the most important goals of the

Postal Service’s international mission is

the development of services that

enhance the ability of U.S. companies to

do business in other countries. This

responsibility was delineated in 39

U.S.C. 403(b)(2), which makes it the

obligation of the Postal Service ‘‘to

provide types of mail service to meet the

needs of different categories of mail and

mail users.’’ Global Package Link is

designed to more closely meet the needs

of customers who send merchandise

packages from the United States to

multiple international addresses by

simplifying the process companies use

to prepare their packages for mailing

and by reducing the costs those

companies incur in mailing

merchandise to other countries. Global

Package Link makes it easier and more

economical for businesses in the United

States to export their products to

international markets.

In late 1994, with implementation of

International Package Consignment

Service, later renamed Global Package

Link, to Japan (59 FR 65961; December

22, 1994), the Postal Service announced

that, when feasible, it would expand the

service to other destination countries

based on customer requests. The Postal

Service later expanded GPL by adding

Canada, the United Kingdom, Brazil,

Chile, China, Germany, Mexico, and