Papaya, Carambola, and Litchi From Hawaii

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

7 CFR Parts 300 and 318

[Docket No. 95-069-2]

Papaya, Carambola, and Litchi From Hawaii

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: We are increasing the irradiation treatment dose required for

papayas intended for interstate movement from Hawaii and allowing

carambolas to be moved interstate from Hawaii with irradiation

treatment. We are also allowing litchis to be moved interstate from

Hawaii if they are inspected and found free of the litchi fruit moth

and other plant pests and undergo irradiation or hot water treatment

for fruit flies. We are allowing papayas, carambolas, and litchis from

Hawaii to undergo irradiation treatment either in Hawaii or in non-

fruit fly supporting areas of the mainland United States. In addition,

we are making several amendments to the requirements for irradiation

procedures and facilities and the handling of treated and untreated

fruits and vegetables. Finally, we are amending the definition for

inspector to include State plant regulatory officials designated by the

Administrator of the Animal and Plant Health Inspection Service, U.S.

Department of Agriculture. These actions will facilitate the interstate

movement of papayas, carambolas, and litchis from Hawaii while

continuing to provide protection against the spread of injurious plant

pests from Hawaii to other parts of the United States.

EFFECTIVE DATE: July 10, 1997. The incorporation by reference of

certain publications listed in the regulations is approved by the

Director of the Federal Register as of July 10, 1997.

FOR FURTHER INFORMATION CONTACT: Mr. Peter M. Grosser, Senior Staff

Officer, Port Operations, PPQ, APHIS, 4700 River Road Unit 139,

Riverdale, MD 20737-1236, (301) 734-6799.

SUPPLEMENTARY INFORMATION:

Background

The Hawaiian Fruits and Vegetables regulations, contained in 7 CFR

318.13 through 318.13-17 (referred to below as the regulations),

govern, among other things, the interstate movement of fruits and

vegetables, including papayas, from Hawaii. Regulation is necessary to

prevent the spread of the Mediterranean fruit fly (Ceratitis capitata),

the melon fly (Bactrocera cucurbitae), and the Oriental fruit fly

(Bactrocera dorsalis), which occur in Hawaii. These types of fruit

flies are collectively referred to in this document as Trifly.

The regulations allow papayas to be moved interstate from Hawaii to

any destination in the United States if, among other things, they have

been treated for Trifly. One approved treatment for Trifly in papayas

is irradiation. Prior to the effective date of this final rule,

Sec. 318.13-4f provided for irradiation of papayas, but no other

fruits, at an approved facility in Hawaii at an irradiation dose of 150

Gray (15 krad).

On July 23, 1996, we published in the Federal Register (61 FR

38108-38114, Docket No. 95-069-1) a proposal to amend the regulations

by increasing the irradiation treatment dose required for papayas

intended for interstate movement from Hawaii; allowing carambolas to be

moved interstate from Hawaii with irradiation treatment; allowing

litchis to be moved interstate from Hawaii if they are inspected and

found free of the litchi fruit moth and undergo irradiation or hot

water treatment for fruit flies; allowing papayas, carambolas, and

litchis from Hawaii to undergo irradiation treatment either in Hawaii

or in non-fruit fly supporting areas of the mainland United States;

making several amendments to the requirements for irradiation

procedures and facilities and the handling of treated and untreated

fruits and vegetables; and amending the definition of inspector to

include State plant regulatory officials designated by the

Administrator of the Animal and Plant Health Inspection Service

(APHIS), U.S. Department of Agriculture.

We solicited comments concerning our proposal for 30 days ending

August 22, 1996. We received 45 comments by that date. They were from

growers, producers, university personnel, and representatives of

industry, irradiation associations, and State governments. One

commenter supported the proposed rule in its entirety. The remaining 44

commenters had concerns about portions of the proposed rule. Their

concerns are discussed below.

Comment: APHIS should not allow Trifly host fruit from Hawaii to be

shipped to the mainland United States for treatment. Treatments should

be conducted before the fruit leaves Hawaii. Arrival of untreated

Trifly host material on the mainland United States, even in non-fruit

fly supporting areas, would present too great a risk of Trifly being

introduced into susceptible States. Factors contributing to this risk

include misrouting, diversion of shipments, and repackaging and

redistribution prior to treatment; the possibility of planes carrying

untreated fruit crashing in susceptible States; and the possible

establishment of Trifly in northern States during the summer months,

with subsequent movement of infected host material into susceptible

States.

Response: With the careful growing practices of Hawaii's commercial

growers, such as administering pre-harvest chemical controls and

keeping production fields clear of fallen fruit during harvest, we

believe that occurrence of Trifly in cartons of untreated fruit from

Hawaii will be rare. We believe that the packaging and movement

provisions established by this rule for shipments of papaya, carambola,

and litchi moving interstate to the mainland United States from Hawaii

for treatment will further protect the mainland United States from the

introduction of Trifly.

Specifically, untreated carambola, litchi, and papaya moving

interstate to the mainland United States for treatment may not be moved

with treated fruits or vegetables. This will prevent treated

commodities from becoming infested with Trifly, and help ensure that

untreated fruit is not inadvertently distributed in the United States

with treated fruit. Although our rule allows untreated fruit bound for

[[Page 36968]]

treatment on the mainland United States to be packaged in either non-

vented or vented cartons, any Trifly that might be present in the

shipment would most likely be eggs and larvae, and it is unlikely that

eggs and larvae would escape from normal vented packaging.

In addition, in the unlikely event that a shipment of untreated

papaya, carambola, or litchi from Hawaii contains an injurious plant

pest that escapes from a carton after arriving on the mainland United

States, the areas into which shipments of untreated fruit from Hawaii

may move are limited to those where Trifly would not be able to sustain

a reproducing population. Irradiation treatment on the mainland United

States may not be conducted in Alabama, Arizona, California, Florida,

Georgia, Kentucky, Louisiana, Mississippi, Nevada, New Mexico, North

Carolina, South Carolina, Tennessee, Texas, or Virginia. Prior to

treatment, the papaya, carambola, and litchi may not move into or

through Alabama, Arizona, California, Florida, Georgia, Kentucky,

Louisiana, Mississippi, Nevada, New Mexico, North Carolina, South

Carolina, Tennessee, Texas, or Virginia, except that Dallas/Fort Worth,

Texas, is an authorized stop for air cargo and a transloading location

for shipments that arrive by air but that are subsequently transloaded

into trucks for overland movement from Dallas/Fort Worth into an

authorized State by the shortest route. In addition, both treated and

untreated litchi from Hawaii may not be moved into or distributed in

the State of Florida.

Apart from restricting the movement into Florida of litchi from

Hawaii, we are establishing these movement restrictions because cooler

climates will not support the establishment of successive generations

of fruit flies. All three species of fruit fly identified in this

document are distributed around the world but only establish

reproducing populations in tropical, subtropical, and Mediterranean

climates. For example, these species of fruit fly have had ample

opportunity to establish reproducing populations in more northern

countries such as Canada, Germany, and The Netherlands, where untreated

host material has been imported from countries with climates suitable

for fruit fly establishment for many years; however, the cold climates

of these three northern countries have prevented the establishment of

successive populations of fruit flies. We are confident that these

three species of fruit fly do not have a life stage that can survive

the cold winters of our northern tier States. Additionally, we have

been cold treating fruit fly host material from foreign countries in

the northern United States for many years, and we have not recorded an

established population of fruit flies in any northern State, during

either the summer months or at any other time during the year, as a

result of these imports. Therefore, we do not believe that the

interstate movement of Hawaiian fruit for treatment on the mainland

United States presents a risk of establishing Trifly in States into

which Hawaiian fruit may move prior to treatment during the summer

months or at other times during the year, and we, therefore, do not

expect infested host material to move from northern States into more

susceptible southern States prior to treatment for fruit flies.

Also, papaya, carambola, and litchi moved from Hawaii to the

mainland United States for treatment must be treated prior to

distribution on the mainland United States. The irradiation treatment

for fruit flies, as well as the other treatments outlined in our

proposal, meets probit 9 quarantine security. Probit 9 security means

that no more than 32 per 1,000,000 treated individuals (such as fruit

flies) will pass through treatment and still emerge as adults. Since it

is extremely unlikely that a consignment of fruit from Hawaii could be

infested at such a high rate, a probit 9 level treatment assures that

essentially all target pests will be effectively treated so as to

prevent their adult emergence. Probit 9 is a longstanding APHIS policy.

We believe that probit 9 treatment procedures are sufficient to prevent

the introduction and establishment of plant pests on the mainland

United States.

We acknowledge that there is always the risk of misrouting,

diversion of shipments, or a plane crash, but this risk is negligible.

Further, in order to prevent the accidental misrouting or deliberate

diversion of shipments of untreated fruit from Hawaii bound for

treatment facilities on the mainland United States, each shipment of

fruit from Hawaii requiring treatment on the mainland United States

must move under limited permit. The limited permit will be issued by

inspectors in Hawaii, who will notify APHIS personnel on the mainland

United States of the issuance of the limited permit. The shipment of

untreated fruit will then move interstate to a port staffed by APHIS

personnel on the mainland United States. Therefore, at all points

during the interstate movement, authorized personnel will be on hand to

help prevent accidental misrouting, deliberate diversion, or

repackaging and redistribution of untreated Hawaiian fruit.

Therefore, we are making no changes to the proposed rule in

response to this comment.

Comment: In the absence of an irradiation facility in Hawaii, APHIS

should require other treatments, such as cold or heat treatments,

before fruit from Hawaii is moved interstate to the mainland United

States.

Response: We feel that such cold or heat treatments of papaya,

carambola, and litchi from Hawaii are not necessary because, combined

with the packaging and movement requirements proposed for fruit from

Hawaii, the proposed irradiation treatment for papaya, carambola, and

litchi from Hawaii is sufficient to mitigate the risk of the

introduction and establishment of Trifly and other injurious plant

pests on the mainland United States. Additionally, for some time, we

have permitted the untreated fruit fly host material of a number of

foreign countries to undergo treatment on the mainland United States.

We do not believe that there is cause to ask more of Hawaii than we do

of those foreign countries. Therefore, we are making no changes to the

proposed rule in response to this comment.

Comment: APHIS should require litchis from Hawaii to be cold

treated prior to arrival on the mainland United States. Cold treatment

is now required for litchis imported from foreign countries, such as

Taiwan.

Response: We require cold treatment for litchis imported from

Taiwan because of Oriental fruit fly (Bactrocera dorsalis) and litchi

fruit borer (Conopomorpha sinensis). Though litchi from Hawaii also

must be treated for Oriental fruit fly, as well as other pests, we do

not believe that cold treatment is necessary for Hawaiian litchi. The

hot water and irradiation treatments for litchi provided by this rule,

combined with the movement restrictions discussed previously and the

required inspection for litchi fruit moth and other plant pests, are

sufficient to prevent the introduction of Trifly, litchi rust mite, and

other injurious plant pests into the United States. In the future, we

will consider any request to allow the cold treatment of Hawaiian

litchi as an alternative to irradiation or hot water treatment. At this

time, however, we are making no changes to the proposed rule in

response to this comment.

Comment: APHIS should prohibit litchis from moving into either

Florida or California unless the risk of introducing litchi rust mite,

litchi fruit moth, Koa seedworm (also known as Macadamia nut borer),

and light brown apple moth can be addressed. Regulations and stamps

prohibiting the

[[Page 36969]]

movement of litchis into Florida will not keep infested fruit out of

Florida.

Response: Because of Florida's commercial production of litchi,

litchi from Hawaii will not be allowed to move into or be distributed

in Florida, and cartons of litchi from Hawaii will be stamped with that

information so that they are not inadvertently shipped to Florida.

Though we do not currently have sufficient data to judge the effect

on litchi rust mite (Eriophyes litchi) of the irradiation dose adopted

in this final rule for Trifly (250 Gray), we do expect, based on the

available information, some deleterious effect on any litchi rust mites

in a shipment of litchi that undergoes an irradiation treatment

according to the provisions outlined in the proposal. Yet APHIS is not

relying upon irradiation treatment as the primary means of reducing the

risk associated with the litchi rust mite. We have determined that

there is little chance that a litchi rust mite will stay on a litchi

fruit throughout the growth, harvest, and packing of the litchi fruit.

Litchi rust mite is most closely associated with the leaves and other

plant parts of the litchi. Because we are only allowing the fruit of

the litchi to be moved interstate from Hawaii, we believe that there is

only a remote chance that litchi rust mite will be associated with

fruit that is packed in a shipment of litchi moving interstate from

Hawaii. We believe that the inspection, movement, and treatment

provisions established for litchi by this rule will prevent litchi rust

mite from being introduced into the mainland United States. However, as

an added precaution to ensure protection of Florida's litchi industry,

APHIS is prohibiting movement of Hawaiian litchi into Florida.

Further, we believe that litchi moved interstate from Hawaii under

this rule will present a negligible risk of introducing litchi fruit

moth (Cryptophlebia ombrodelta), Koa seedworm (Cryptophlebia illepida

[Butler]), or light brown apple moth (Epiphyas postvittana) anywhere on

the mainland United States.

The cultural practices employed by Hawaiian tree fruit growers,

such as administering pre-harvest chemical controls, keeping production

fields clear of fallen fruit during harvest, and keeping field borders

clear of hale koa (favored host of Cryptophlebia spp.), greatly reduce

the possibility that litchi fruit moth, Koa seedworm, or light brown

apple moth will be associated with Hawaiian litchi moving to the

mainland United States. However, we are not depending on those growing

practices alone to mitigate the risk of the introduction of these pests

on the mainland United States. Our rule also requires litchi from

Hawaii to be inspected and found free of litchi fruit moth and other

pests (including Koa seedworm and light brown apple moth) prior to

treatment in Hawaii or prior to interstate movement if the litchi will

be treated on the mainland United States. Each of these pests is

readily detectable by inspection. We believe that the control and

suppression measures used by Hawaiian commercial growers and the

inspection of the litchi will mitigate the risk of the introduction of

these pests onto the mainland United States.

In the preamble of our proposal, we stated that each shipment of

litchi, whether treated in Hawaii or moving to the mainland United

States for treatment, would be inspected in Hawaii prior to treatment

or interstate movement for litchi fruit moth and other pests of

concern. However, in the rule portion of our proposal, we did not make

the inspection provisions clear for litchi undergoing irradiation

treatment. Therefore, we have revised Sec. 318.13-4f(b)(7)(i) and (ii)

to clarify that all litchi from Hawaii must be inspected in Hawaii and

found free of litchi fruit moth and other pests of concern prior to

treatment or interstate movement.

Comment: APHIS should require untreated fruit, as well as treated

fruit, to be packaged in a pest-proof carton, and the carton to be

sealed before the fruit is to be moved from Hawaii. This would provide

additional quarantine security.

Response: We proposed that all treated carambola, litchi, and

papaya be packaged in pest-proof cartons to protect the fruit from re-

infestation by Trifly. We proposed to allow untreated carambola,

litchi, and papaya moving interstate to the mainland United States to

move in either non-vented or in vented cartons. We proposed this

flexibility for the packaging of untreated fruit because prevention of

reinfestation is not an issue and because, as explained earlier in this

document, any Trifly that might be present in the shipment would most

likely be eggs and larvae, and it is unlikely that eggs and larvae

could escape from normal vented packaging. Additionally, if Trifly eggs

and larvae were present in the shipment, and if they reached maturity

and escaped, it is unlikely that they could establish a reproducing

population in the areas in which movement of untreated fruit will be

authorized under the regulations because of either the relatively cool

climate or the lack of suitable commercial host material in those

areas. Untreated carambola, litchi, and papaya must be treated before

being distributed outside these areas.

We agree with the commenter that seals are a good way to help

ensure the proper handling of shipments. Under our proposal, each

carton of fruit treated in Hawaii that moves interstate to the mainland

United States would be required to be sealed with seals that visually

indicate if the cartons have been opened. However, we did not propose

to require seals for cartons of untreated fruit. In response to this

comment, we are requiring seals for shipping containers of untreated

fruit moving interstate from Hawaii, as well as cartons of fruit

treated in Hawaii. Because cartons of untreated Hawaiian fruit will be

placed in sealed shipping containers prior to interstate movement to

the mainland United States, we have determined that it is not necessary

to seal each carton of untreated fruit. This provision would help

ensure that no cartons within the sealed shipping container have been

tampered with or removed. Therefore, we are amending Sec. 301.13-

4f(b)(4)(i) to require that shipping containers of untreated papaya,

litchi, and carambola from Hawaii be sealed prior to interstate

movement with seals that will visually indicate if the shipping

containers have been opened.

Comment: The requirement that each carton of treated fruit be

stamped ``Treated--USDA, APHIS'' should be retained to ensure product

differentiation at the treatment facility and in the distribution

channels afterward.

Response: In order to ensure that no cartons are added to or

removed from a pallet load of cartons of Hawaiian fruit moving to the

mainland United States, we proposed that pallet loads be wrapped in one

of the following ways: With polyethylene sheet wrap, with net wrapping,

or with strapping so that each carton on an outside row of the pallet

load is constrained by a metal or plastic strap. We further proposed to

require that pallet loads of treated carambola, litchi, and papaya be

marked with treatment lot numbers, packing and treatment facility

identification and locations, and dates of packing and treatment so

that an inspector could identify the treatment lots of shipments and

trace shipments back to the facilities where they were packed and

treated. We proposed this method of labeling to replace the requirement

that individual cartons be marked with a ``Treated'USDA, APHIS'' stamp.

We believe that our proposed method will offer more information than

our current method about a shipment or shipments

[[Page 36970]]

of fruit from Hawaii if an infestation is detected on the mainland

United States. Therefore, we are making no changes to the proposed rule

in response to this comment.

Comment: Only fruit treated in Hawaii should be required to be

packaged in pest-proof cartons.

Response: We agree. Under our proposal, only carambola, litchi, and

papaya from Hawaii that are treated in Hawaii will have to move in

pest-proof cartons, in accordance with Sec. 318.13-4f(b)(4)(i)(A).

Carambola, litchi, and papaya from Hawaii that are treated on the

mainland United States, and carambola, litchi, and papaya moving to the

mainland United States for treatment, will not have to move in pest-

proof cartons. Carambola, litchi, and papaya from Hawaii that are

treated on the mainland United States will not be subject to further

possible invasion by pests of concern after treatment, so we do not

believe that cartons carrying these treated fruits need to be pest-

proof. Fruit moving to the mainland United States for treatment also

does not need to be shipped in pest-proof cartons for reasons explained

earlier in this document. Therefore, we are making no changes to the

proposed rule in response to this comment.

Comment: If fruit is allowed to move to the mainland United States

from Hawaii for treatment, the production areas in Hawaii should be

required to undergo malathion bait spray treatments, beginning 30 days

before harvest begins and continuing until harvest ends.

Response: Treating production areas with bait spray, consisting of

95 percent malathion ULV mixed with a protein hydrolyzate applied at

the rate of 2.4 ounces of malathion mixed with 9.6 ounces of protein

hydrolyzate per acre, applied at 7 to 10 day intervals, with treatments

commencing 30 days prior to harvest and continuing until harvest is

complete, was a common practice in APHIS' eradication of the

Mediterranean fruit fly (Medfly) in California in the 1980s. Bait spray

treatments would be effective in suppressing the fruit fly population

in production areas of Hawaii; however, it does not seem necessary to

require bait spray treatments in addition to the treatment and other

procedures required by this rule, because we believe these procedures

provide security against the introduction and establishment of fruit

flies and other pests on the mainland United States. Therefore, we are

making no changes to the proposal in response to this comment.

Comment: It is important that an inspector be physically present at

the time of treatment either in Hawaii or on the mainland United

States; therefore, the description of irradiation treatment procedures

should include the phrase ``under the supervision of an inspector.''

Response: Regarding the phrase ``under the supervision of an

inspector'' in relation to irradiation treatment, each and every

irradiation treatment conducted on the mainland United States is not

required to be directly supervised by an APHIS inspector. Instead, it

is our intent to certify the irradiation facility and its operators

initially and renew that certification every year. This certification,

coupled with the placement of dosimeters, in accordance with ASTM

standards, helps to ensure that the irradiation treatment process is

completed carefully and accurately. Therefore, we are making no changes

to the proposed rule in response to this comment.

Comment: If there are no dose indicators on a shipment, what will

you do to be sure records will allow traceback?

Response: This rule requires a treatment facility to have

dosimeters to accurately measure the absorbed irradiation dose for each

lot of fruit treated at the facility. After the treatment is conducted,

the shipment must be marked with its treatment lot number, packing and

treatment facility identification and location, and date of packing and

treatment so that an inspector can identify the treatment lot of the

shipment and trace the shipment back to the facility where it was

packed and treated. At the irradiation facility where the treatment

took place, the records of irradiation treatment and the measurements

of the dosimeters must be available for APHIS review and verification.

Comment: What is your rationale for increasing the irradiation dose

from 150 Grays to 250 Grays?

Response: USDA scientists have done exhaustive reviews of the

published research related to irradiation treatments for fruit flies.

These scientists also have conducted research to prove the efficacy of

quarantine treatments, including irradiation treatments. APHIS'

adoption of 250 Gray as the minimum dose for the fruit flies of concern

from Hawaii is based on the recommendation of these scientists after

considering the level of quarantine security required by APHIS, the

species of flies to be treated, and the level of confidence provided by

current information.

Quarantine security involves defining two primary variables, the

required endpoint and the level of efficacy. The endpoint for most

quarantine treatments is mortality. However, an advantage associated

with irradiation is the opportunity to select from a range of endpoints

including mortality, the inability to mature, and the inability for

pests to reproduce (sterility). The endpoint adopted by APHIS for fruit

flies is ``preventing adult emergence.'' Mortality is deemed to be an

excessive requirement that would result in significantly higher doses

that are also more likely to cause damage to the commodity. Sterility

as an endpoint provides quarantine security and is likely to require a

lower dose, but it causes regulatory problems because the milder dose

allows live flies to emerge from fruit. If detected, these flies could

trigger regulatory actions because there is not currently a practical

means to distinguish sterile flies from fertile flies. Therefore, the

appropriate endpoint has been determined by APHIS to be ``preventing

adult emergence.''

The level of efficacy required by APHIS is probit 9. As discussed

above, a probit 9 level treatment assures that essentially all target

pests will be effectively sterilized or destroyed.

The target pests for the treatment of Hawaiian fruit are the Trifly

group, including the Oriental fruit fly, the Medfly, and the melon fly.

The dose of 250 Gray has been determined by APHIS to be necessary to

achieve quarantine security for the Oriental fruit fly. A dose of 225

Gray has been adopted by APHIS for Medfly, and a dose of 210 Gray has

been adopted by APHIS for the treatment of melon fly (see a notice

published in the Federal Register on Wednesday, May 15, 1996, 61 FR

24433-24439, Docket No. 95-088-1). Since any of the three species may

be present in fruit for treatment from Hawaii, APHIS is requiring the

dose for the most resistant species, the Oriental fruit fly.

A dose of 150 Gray has been widely recommended as a generic dose

for all fruit flies. After consultation with USDA and other scientists,

and careful review of the research, APHIS has determined that 150 Gray

is an appropriate dose for several other species of fruit flies,

including four species of Anastrepha and three other species of

Bactrocera. However, we do not believe that the available information

is adequate to support the adoption of 150 Gray as a generic dose for

all fruit flies, given the level of quarantine security required by

APHIS.

APHIS is hopeful that additional research and better information

can be provided to support the adoption of lower doses, possibly below

150 Gray. Information of this nature will be considered by APHIS as it

becomes

[[Page 36971]]

available, and treatment requirements will be adjusted to reflect the

lowest possible effective dose that is deemed to be both operationally

practical and scientifically supportable for the level of quarantine

security required by APHIS for the pests of concern, including fruit

flies. However, at this time, we have determined that, based on

research, quarantine security requires an irradiation dosage of 250

Gray as an appropriate dose to achieve probit 9 efficacy. Therefore, we

are making no changes to the proposed rule in response to this comment.

Comment: The increased irradiation dose of 250 Gray will not kill

all fruit fly larvae in shipments of fruit from Hawaii and is not in

line with the Notice of Policy, The Application of Irradiation to

Phytosanitary Problems, as published in the Federal Register on May 15,

1996 (61 FR 24433-24439, Docket No. 95-088-1).

Response: We agree that a dose of 250 Gray will not kill all Trifly

larvae in the shipments, but research and test treatments under

commercial conditions demonstrate that a high percentage of larvae will

in fact be killed when treated with a 250 Gray minimum dose. This is

because, under commercial conditions, most of the treated lot will

receive a dose two to three times the minimum in order to ensure that

the low point in the load receives the minimum dose. However, the

endpoint for quarantine security that has been adopted by APHIS is not

larval mortality, but the inability of adults to emerge from fruit. We

are confident that the research adequately supports 250 Gray as an

appropriate dose to achieve probit 9 efficacy.

Regarding a possible contradiction of one or more of the policy

statements contained in the Notice of Policy, The Application of

Irradiation to Phytosanitary Problems, the policy notice referred to by

the commenter states the intent of the Agency is to avoid regulatory

overlap, conflict, and ambiguity through cooperation and by harmonizing

requirements across agency, domestic, and international lines of

authority. This is in recognition of the range of authorities involved

with irradiation and the complexity of requirements placed on the

irradiation industry. APHIS remains committed to this policy in the

subject rule and as a standard for regulatory initiatives in general.

For example, the role of the Food and Drug Administration and Nuclear

Regulatory Commission is acknowledged and well-integrated into the

authorization for the irradiation of Hawaiian fruits and vegetables

(see Sec. 318.13-4f(e)).

The issue of quarantine security, however, is clearly central to

the charge and authority of APHIS. It is in this regard that the

decision concerning dose becomes a function of APHIS' positions on the

desired level of protection and the degree of confidence placed on

information used to support various proposals. The primary principles

to consider in this respect are consistency, equivalency, and the risk

basis for requirements. However, the doses adopted by APHIS in some

instances may vary from those adopted by other countries or the

recommendations of international organizations when APHIS determines

that there is a high risk which justifies and supports an increased

level of protection. APHIS' doses are believed to be consistent with

the level of quarantine security and the quality of supporting data

used for similar treatment situations. APHIS remains open to any new

information that may lead to lower dose levels and greater

harmonization. However, at this time, we are making no changes to the

proposed rule in response to this comment.

Comment: Technical corrections need to be made regarding the

irradiation terminology (ASTM) in the proposal.

Response: We agree that technical corrections, including the

replacement of the term ``dose indicator'' with the term ``dosimeter''

in Sec. 318.13-4f(b)(6)(ii) and the amendment of footnote 6 of the rule

portion of this document, need to be made in our irradiation

terminology. Accordingly, we are amending Sec. 318.13-4f(b)(6)(ii) to

read ``dosimeter'' instead of ``dose indicator,'' and footnote 6 to

read ``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.''

Comment: Only fruit (no leaves or stems) from Hawaii should be

allowed to enter the mainland United States because fruit flies and

other plant pests may hide in leaves and stems.

Response: We are only allowing the fruit of carambola, litchi, and

papaya from Hawaii to move interstate to the mainland United States. It

is customary in shipping such fruits that only the fruit, without

leaves, stems, or other plant parts, be packaged in a shipment.

Therefore, we are making no changes to the proposed rule in response to

this comment.

Comment: Will you allow non-fruit fly host material, such as

pineapples, in the same shipment as treated fruit?

Response: Untreated fruit, whether fruit fly host material or not,

must not be packed in the same carton as treated fruit (see

Sec. 318.13-4f(b)(2)(ii)). Non-fruit fly host material may be moved in

the same pallet load as treated fruit because there is negligible risk

that non-fruit fly host material would contain fruit flies that could

re-infest treated fruit and because treated fruit must move to the

mainland United States in pest-proof cartons.

Comment: The criteria for the locations of future mainland

irradiation treatment facilities should be in line with the criteria

for locations of cold treatment facilities to prevent the introduction

and establishment of fruit flies on the mainland United States.

Response: We believe that fruit fly host material moving to the

mainland United States from Hawaii for irradiation treatment should be

allowed to be treated only at those locations that will not support the

establishment of successive generations of fruit flies. At this time,

we are limiting the areas where irradiation treatment may be conducted

on the mainland United States to States other than Alabama, Arizona,

California, Florida, Georgia, Kentucky, Louisiana, Mississippi, Nevada,

New Mexico, North Carolina, South Carolina, Tennessee, Texas, or

Virginia. However, we are considering the possibility of allowing

irradiation facilities to operate in other locations on the mainland

United States where cold treatment of fruit flies has been approved.

Comment: Changing the definition of ``inspector'' will reduce the

standard of inspection.

Response: Our proposed revision to the definition of ``inspector''

will allow State cooperators to inspect and issue limited permits for

fruit moving interstate from Hawaii under our regulations. To be

eligible for designation as an inspector under the regulations, a State

plant regulatory official must have a bachelor's degree in the

biological sciences, a minimum of 2 years' experience in State plant

regulatory activities, and a minimum of 2 years' experience in

recognizing and identifying plant pests known to occur within Hawaii.

Six years' experience in State plant regulatory activities may be

substituted for the degree requirement. As explained in our proposed

rule, these requirements are based on the qualifications in 7 CFR 353

for State plant regulatory officials who provide phytosanitary

certification for plants and plant products exported from the United

States. We believe our expanded definition of ``inspector'' will

facilitate the inspection process while continuing to provide

protection against the spread of injurious plant pests from Hawaii to

other parts of the United States.

[[Page 36972]]

Therefore, we are making no changes to the proposed rule in response to

this comment.

We are also making nonsubstantive editorial changes for clarity.

We feel confident that with the provisions outlined in our proposal

and in this document, carambola, litchi, and papaya can move interstate

from Hawaii to the mainland United States without presenting a

significant risk of pest introduction or establishment on the mainland

United States.

Therefore, based on the rationale set forth in the proposed rule

and in this document, we are adopting the provisions of the proposal as

a final rule with the changes discussed above.

Effective Date

Though this rule does change certain irradiation dosage and

packaging requirements for papaya treated in Hawaii, there are

currently no irradiation facilities in Hawaii to treat papaya;

therefore, no one will be adversely affected by this rule. The other

provisions contained in this rule relieve restrictions on the

interstate movement of papaya, carambola, and litchi from Hawaii to the

mainland United States. As such, this is a substantive rule that

relieves restrictions and, pursuant to the provisions of 5 U.S.C. 553,

may be made effective less than 30 days after publication in the

Federal Register. Immediate implementation of this rule is necessary to

provide relief to those persons who are adversely affected by

restrictions we no longer find warranted. The shipping season for

litchi from Hawaii began in May and continues through August. Making

this rule effective immediately will allow interested producers and

others in the marketing chain to benefit during this year's shipping

season. Therefore, the Administrator of the Animal and Plant Health

Inspection Service has determined that this rule should be effective

upon publication in the Federal Register.

Executive Order 12866 and Regulatory Flexibility Act

This rule has been reviewed under Executive Order 12866. The rule

has been determined to be not significant for purposes of Executive

Order 12866 and, therefore, has not been reviewed by the Office of

Management and Budget.

In accordance with 5 U.S.C. 604, we have performed a Final

Regulatory Flexibility Analysis, which is set out below, regarding the

impact of this final rule on small entities.

In accordance with 7 U.S.C. 162, the Secretary of Agriculture is

authorized to promulgate regulations governing the interstate movement

of plants and plant products from a State or territory of the United

States to prevent the spread of a dangerous plant disease or insect

infestation new to or not widely prevalent or distributed within or

throughout the United States.

This rule amends the regulations by increasing the irradiation

treatment dose required for papayas intended for interstate movement

from Hawaii, by allowing carambolas to be moved interstate from Hawaii

with irradiation treatment, and by allowing litchis to be moved

interstate from Hawaii if they are inspected and found free of the

litchi fruit moth and other plant pests and undergo irradiation or hot

water treatment for fruit flies. We are allowing papayas, carambolas,

and litchis from Hawaii to undergo irradiation treatment either in

Hawaii or in non-fruit fly supporting areas of the mainland United

States. In addition, we are making several amendments to the

requirements for irradiation procedures and facilities and the handling

of treated and untreated fruits and vegetables. Finally, this rule

amends the definition for inspector to include State plant regulatory

officials designated by the Administrator of the Animal and Plant

Health Inspection Service, U.S. Department of Agriculture. These

actions will facilitate the interstate movement of papayas, carambolas,

and litchis from Hawaii while continuing to provide protection against

the spread of injurious plant pests from Hawaii to other parts of the

United States. Economic impacts associated with this rulemaking will

largely be the result of untreated papayas, carambolas, or litchis

being allowed to move to the mainland United States for irradiation

treatment.

In our proposal, we solicited comments on the potential effects of

the proposed action on small entities. In particular, we sought data

and other information to determine the number and kind of small

entities that may incur benefits or costs from the implementation of

the proposed rule. We received one comment on the Initial Regulatory

Flexibility Analysis contained in the proposed rule. The commenter said

that our determination that the proposal was not economically

significant was incorrect; the commenter remarked that the provisions

of the proposal are economically significant, particularly if, after

the adoption of the proposal, a pest eradication program must commence.

We believe that the treatment and other procedures established in

this rule for the interstate movement of carambola, litchi, and papaya

will mitigate the risk of pest introduction and establishment on the

mainland United States. Therefore, we do not believe that a pest

eradication program will be necessary as a result of this rule, or that

the rule will otherwise have a significant economic impact on U.S.

entities, large or small. As discussed below, Hawaii produces a small

quantity of carambola and litchi when compared to the production of

these commodities in the rest of the United States, and Hawaiian papaya

shipments to the mainland United States totaled less than half of the

quantity of papaya that the United States imported from foreign nations

in 1994.

Papayas

Papayas are produced commercially on about 340 farms in Hawaii.

Nearly 65 percent of those farms are owned by individuals whose major

occupation is not farming, while the balance are operated by

individuals whose major occupation is farming.

Papaya farms with average annual revenues of less than $500,000 are

considered small. All papaya farms in Hawaii are therefore considered

small.

In 1994, Hawaii produced 62 million pounds of papaya (valued at $15

million). Fresh papaya comprised 56.2 million pounds of this total.

During that year, Hawaii shipped about 37.8 million pounds of papaya.

Shipment of fresh papaya to the mainland totaled about 19.4 million

pounds, and the remainder was exported to other countries. Of the

approximately 19.4 million pounds of fresh papayas shipped from Hawaii

to the mainland in 1994, most went to the West Coast. Seventy-five

percent of them were sold directly to retailers, and the rest were sold

to wholesalers.

The United States imported about 41.2 million pounds of fresh

papaya (valued at $10.9 million) in 1994. Most of the imported papayas

came from Mexico (80 percent), Belize (9.6 percent), Jamaica (6.3

percent), and the Dominican Republic (1.9 percent). The United States

exported 18.4 million pounds of fresh papayas (valued at $15.4 million)

in 1994. The major importers were Japan (66.8 percent) and Canada (27.1

percent). Almost all United States exports of papayas go out of Hawaii,

while all imports come into the mainland United States.

There are five firms currently operating nine papaya treatment

facilities in the State of Hawaii. Four firms use the vapor-heat

treatment method and one uses the dry heat (or high-temperature forced

air) method. The total capacity of these treatment chambers is 85,000

pounds per run.

[[Page 36973]]

Both heat treatment methods have the potential to damage the

papayas. They require the center of each papaya fruit to reach about 47

deg.C (about 117 deg.F), a temperature sufficient to kill fruit fly

eggs and larvae. Because of variation in fruit size and ripeness, the

papayas may not be uniformly heated. This may result in the fruit

becoming lumpy and losing flavor. For both methods, careful control of

the uniformity of fruit size and ripeness is necessary for effective

treatment. In addition, both methods require between 4 and 6 hours of

treatment. Efforts to speed up the process result in fruit which is

either scalded externally or hardened on the inside. The cost of

treatment for both methods ranges from 9 to 23 cents per pound.

Although the regulations currently allow papayas to be treated by

irradiation in Hawaii, there are no irradiation facilities in that

State. Allowing irradiation to be performed on the mainland appears to

be an attractive option. The subsequent diversion of untreated papayas

from Hawaii to the mainland would likely result in loss of business to

the existing vapor heat and dry heat facilities. This could result in

lay-offs and possibly the shut-down of some of these facilities.

However, if papaya producers respond by producing more papayas,

continuing traditional treatment for some and shipping others for

irradiation, this will not necessarily occur.

Carambolas

The United States produced about 6 million pounds of carambola in

1994, with a total value of approximately $4 million to $4.5 million.

In the United States, carambola is grown on about 100 farms. All of

these farms have a market value of less than $500,000 and are thus

considered to be small businesses according to the Small Business

Administration's size standards.

In 1994, Hawaii produced only about 50,700 pounds of carambola,

valued at approximately $38,000, on 30 farms. The provisions proposed

in this rule concerning irradiation treatment of carambola fruits by

the mainland facilities are expected to stimulate growth of the

carambola industry in Hawaii and provide greater access to the larger

mainland market.

No economic impact on mainland carambola growers is anticipated,

since the total Hawaii production of carambola is less than one percent

of the mainland production. Therefore, even in the unlikely event that

Hawaii could ship 100 percent of its production to the mainland, supply

would only increase by less than one percent. However, mainland

consumers would likely benefit from increased seasonal and regional

availability, as well as from the increased variety of fresh carambola.

Additionally, carambola growers in Hawaii would benefit from the

opportunity to sell their product in a larger and more diverse market.

This rule will enable carambola from Hawaii to be irradiated at an

existing irradiation facility on the mainland and is not expected to

impose additional costs on carambola producers in Hawaii. We expect

that carambola producers in Hawaii will benefit from the proposed

irradiation treatment because this treatment can deliver better product

quality, extended shelf life of the fruit, and cost effective treatment

of the fruit. However, the overall impact of the carambola provisions

of the proposed rule is expected to be insignificant.

Litchis

Litchis are produced commercially on 55 farms in Hawaii. In 1993,

the United States produced about 770,000 pounds of litchi. Of that

total, approximately 85,000 pounds was produced in Hawaii.

Litchi farms with average annual revenues of less than $500,000 are

considered small. All litchi farms in Hawaii are considered small.

The litchi industry in Hawaii has been constrained by the lack of

an approved treatment for fruit flies since the cancellation of

ethylene dibromide in 1984. Approving irradiation treatment of litchis

on the mainland is expected to stimulate growth of the industry and

provide access to the larger mainland market. No information is

available on the effect of approving inspection and hot water treatment

as an alternative method for moving litchis interstate.

The United States is a net importer of fresh litchi, with a total

import of about 165,000 pounds in 1994. In 1994, nearly 70 percent of

imported litchi came from Mexico; the remainder came from Israel. The

total supply of litchi on the mainland is about 850,000 pounds.

Wholesale prices of litchi range between $1.00 per pound and $4.50 per

pound.

The economic impact on mainland litchi growers and prices on the

mainland will not be significant. Even in the unlikely event that

Hawaii shipped 25 percent of its production to the mainland, supply

will increase by only about 2.3 percent. However, mainland consumers

will benefit from increased seasonal and regional availability, an

increased variety of fresh litchi, and stable prices. Additionally,

litchi growers in Hawaii will benefit from the increased opportunity to

sell their product in a larger and more diverse market.

According to recent research conducted by the ARS, irradiation

appears to be an effective treatment option that does not require

control of either fruit size or ripeness. Irradiation typically

requires only 40 minutes for treatment. The irradiation method may be

more cost effective depending on volume treated, because it costs only

about 5 to 12 cents per pound.

This rule is expected to benefit producers, since irradiation

appears to offer a number of advantages over current treatment options,

including greater flexibility of fruit size and ripeness, reduction in

treatment time, improved effectiveness against pest infestation, better

product quality, extended shelf life, and improved cost effectiveness.

Consumers also may benefit from a better quality product. The overall

impact upon supply, price, and competitiveness is expected to be

insignificant.

This rule contains information collection requirements. These were

described in detail in the proposed rule as required by the Paperwork

Reduction Act of 1995. Further, as required by that Act, we solicited

public comment on the proposed information collection requirements and

submitted them to the Office of Management and Budget for approval. See

the statement in this document under the heading ``Paperwork Reduction

Act.''

The alternative to this rule is to take no action. We do not

consider taking no action a reasonable alternative. Papayas may move

interstate to the mainland United States only with thermal treatment,

and carambolas and litchis are not currently moved interstate from

Hawaii because of a lack of suitable treatment options. This rule will

facilitate the interstate movement of papayas, carambolas, and litchis

from Hawaii while continuing to provide protection against the spread

of injurious plant pests from Hawaii to other parts of the United

States.

Executive Order 12372

This program/activity is listed in the Catalog of Federal Domestic

Assistance 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. State and local laws and regulations that are

inconsistent with this rule will be preempted. No

[[Page 36974]]

retroactive effect will be given to this rule. Administrative

proceedings will not be required before parties may file suit in court

challenging this rule.

Paperwork Reduction Act

In accordance with section 3507(d) of the Paperwork Reduction Act

of 1995 (44 U.S.C. 3501 et seq.), the information collection or

recordkeeping requirements included in this final rule have been

approved by the Office of Management and Budget (OMB). The assigned OMB

control number is 0579-0123.

List of Subjects

7 CFR Part 300

Incorporation by reference, Plant diseases and pests, Quarantine.

7 CFR Part 318

Cotton, Cottonseeds, Fruits, Guam, Hawaii, Incorporation by

reference, Plant diseases and pests, Puerto Rico, Quarantine,

Transportation, Vegetables, Virgin Islands.

Accordingly, 7 CFR parts 300 and 318 are amended as follows:

PART 300--INCORPORATION BY REFERENCE

1. The authority citation continues to read as follows:

Authority: 7 U.S.C. 150ee, 154, 161, 162, and 167; 7 CFR 2.22,

2.80, and 371.2(c).

2. In Sec. 300.1, paragraph (a), the introductory text is revised

to read as follows:

Sec. 300.1 Materials incorporated by reference; availability.

(a) Plant Protection and Quarantine Treatment Manual. The Plant

Protection and Quarantine Treatment Manual, which was reprinted on

November 30, 1992, and includes all revisions through April 1997, has

been approved for incorporation by reference in 7 CFR chapter III by

the Director of the Office of the Federal Register in accordance with 5

U.S.C. 552(a) and 1 CFR part 51.

* * * * *

PART 318--HAWAIIAN AND TERRITORIAL QUARANTINE NOTICES

3. The authority citation for part 318 continues to read as

follows:

Authority: 7 U.S.C. 150bb, 150dd, 150ee, 150ff, 161, 162, 164a,

and 167; 7 CFR 2.22, 2.80, and 371.2(c).

4. In Sec. 318.13-1, the definition for Inspector is amended to

read as follows:

Sec. 318.13-1 Definitions.

* * * * *

Inspector. An employee of Plant Protection and Quarantine, or a

State plant regulatory official designated by the Administrator to

inspect and certify to shippers and other interested parties, as to the

condition of the products inspected. To be eligible for designation, a

State plant regulatory official must have a bachelor's degree in the

biological sciences, a minimum of 2 years' experience in State plant

regulatory activities, and a minimum of 2 years' experience in

recognizing and identifying plant pests known to occur within Hawaii.

Six years' experience in State plant regulatory activities may be

substituted for the degree requirement.

* * * * *

5. In Sec. 318.13-3, a new paragraph (b)(3) is added to read as

follows:

Sec. 318.13-3 Conditions of movement.

* * * * *

(b) * * *

(3) Untreated fruits and vegetables from Hawaii may be moved

interstate for irradiation treatment on the mainland United States if

the provisions of Sec. 318.13-4f are met and if the fruits and

vegetables are accompanied by a limited permit issued by an inspector

in accordance with Sec. 318.13-4(c). The limited permit will be issued

only if the inspector examines the shipment and determines that the

shipment has been prepared in compliance with the provisions of this

subpart.

* * * * *

6. A new Sec. 318.13-4e is added to read as follows:

Sec. 318.13-4e Administrative instructions governing the movement of

litchis from Hawaii to other States.

(a) Litchis may be moved interstate from Hawaii only in accordance

with this section or Sec. 318.13-4f and all other applicable provisions

of this part.

(b) To be eligible for interstate movement under this section,

litchi must be inspected and found free of the litchi fruit moth

(Cryptophlebia spp.) and other plant pests by an inspector and then

treated for fruit flies under the supervision of an inspector with a

treatment listed in the Plant Protection and Quarantine Treatment

Manual, which is incorporated by reference at Sec. 300.1 of this

chapter.

(c) Litchi from Hawaii may not be moved interstate into Florida.

All cartons in which litchi from Hawaii are packed must be stamped

``Not for importation into or distribution in FL.''

7. Section 318.13-4f is revised to read as follows:

Sec. 318.13-4f Administrative instructions prescribing methods for

irradiation treatment of certain fruits and vegetables from Hawaii.

(a) Approved irradiation treatment. Irradiation, carried out in

accordance with the provisions of this section, is approved as a

treatment for the following fruits and vegetables: carambola, litchi,

and papaya.

(b) Conditions of movement. Fruits and vegetables from Hawaii may

be authorized for movement in accordance with this section only if the

following conditions are met:

(1) Location. The irradiation treatment must be carried out at an

approved facility in Hawaii or on the mainland United States. Fruits

and vegetables authorized under this section for treatment on the

mainland may be treated in any State on the mainland United States

except Alabama, Arizona, California, Florida, Georgia, Kentucky,

Louisiana, Mississippi, Nevada, New Mexico, North Carolina, South

Carolina, Tennessee, Texas, or Virginia. Prior to treatment, the fruits

and vegetables may not move into or through Alabama, Arizona,

California, Florida, Georgia, Kentucky, Louisiana, Mississippi, Nevada,

New Mexico, North Carolina, South Carolina, Tennessee, Texas, or

Virginia, except that movement is allowed through Dallas/Fort Worth,

Texas, as an authorized stop for air cargo, or as a transloading

location for shipments that arrive by air but that are subsequently

transloaded into trucks for overland movement from Dallas/Fort Worth

into an authorized State by the shortest route.

(2) 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 250 Gray (25 krad) to the fruits and

vegetables;2

---------------------------------------------------------------------------

\2\ The maximum absorbed ionizing radiation dose and the

irradiation of food is regulated by the Food and Drug Administration

under 21 CFR part 179.

---------------------------------------------------------------------------

(ii) Be constructed so as to provide physically separate locations

for treated and untreated fruits and vegetables, except that fruits and

vegetables traveling by conveyor directly into the irradiation chamber

may pass through an area that would otherwise be separated. The

locations must be separated by a permanent physical barrier such as a

wall or chain link fence six or more feet high to prevent transfer of

cartons. Untreated fruits and vegetables shipped to the mainland United

States from Hawaii in

[[Page 36975]]

accordance with this section may not be packaged for shipment in a

carton with treated fruits and vegetables;

(iii) Complete a compliance agreement with the Animal and Plant

Health Inspection Service as provided in Sec. 318.13-4(d) 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.

(3) Treatment monitoring. Treatment must be carried out under the

monitoring of an inspector. This monitoring must include inspection of

treatment records and unannounced inspectional 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.\3\

---------------------------------------------------------------------------

\3\ Inspectors are assigned to local offices of the Animal and

Plant Health Inspection Service, which are listed in telephone

directories.

---------------------------------------------------------------------------

(4) Packaging. (i) Fruits and vegetables that are treated in Hawaii

must be packaged in the following manner:

(A) 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.4

---------------------------------------------------------------------------

\4\ 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.

---------------------------------------------------------------------------

(B) The pallet-load of cartons must be wrapped before it leaves the

irradiation facility in one of the following ways:

(1) With polyethylene sheet wrap;

(2) With net wrapping; or

(3) With strapping so that each carton on an outside row of the

pallet load is constrained by a metal or plastic strap.

(C) Packaging must be labeled with treatment lot numbers, packing

and treatment facility identification and location, and dates of

packing and treatment.

(ii) Cartons of untreated fruits and vegetables that are moving to

the mainland United States for treatment must be shipped in shipping

containers sealed prior to interstate movement with seals that will

visually indicate if the shipping containers have been opened.

(iii) Litchi from Hawaii may not be moved interstate into Florida.

All cartons in which litchi from Hawaii are packed must be stamped

``Not for importation into or distribution in FL.''

(5) Dosage. The fruits and vegetables must receive a minimum

absorbed ionizing radiation dose of 250 Gray (25 krad).5

---------------------------------------------------------------------------

\5\ See footnote 2.

---------------------------------------------------------------------------

(6) 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 250 Gray (25 krad).

(iii) The number and placement of dosimeters used must be in

accordance with American Society for Testing and Materials (ASTM)

standards.6

---------------------------------------------------------------------------

\6\ 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.

---------------------------------------------------------------------------

(7)(i) Certification on basis of treatment. A certificate shall be

issued by an inspector for the movement of fruits and vegetables from

Hawaii that have been treated and handled in Hawaii in accordance with

this section. To be certified for interstate movement under this

section, litchi from Hawaii must be inspected in Hawaii and found free

of the litchi fruit moth (Cryptophlebia spp.) and other plant pests by

an inspector before undergoing irradiation treatment in Hawaii for

fruit flies.

(ii) Limited permit. A limited permit shall be issued by an

inspector for the interstate movement of untreated fruits and

vegetables from Hawaii for treatment on the mainland United States in

accordance with this section. To be eligible for a limited permit under

this section, untreated litchi from Hawaii must be inspected in Hawaii

and found free of the litchi fruit moth (Cryptophlebia spp.) and other

plant pests by an inspector.

(8) Records. Records or invoices for each treated lot must be made

available for inspection by an inspector during normal business hours

(8:00 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.

(c) 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 (b)(2) of this section.

(d) Denial and withdrawal of approval. (1) The Administrator will

withdraw the approval of any irradiation treatment facility when the

irradiation processor requests in writing the withdrawal of approval.

(2) 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.

(e) Department not responsible for damage. This treatment is

approved to assure quarantine security against the Trifly complex. From

the literature available, the fruits and vegetables authorized for

treatment under this section are believed tolerant to the treatment;

however, the facility operator

[[Page 36976]]

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 30th day of June 1997.

Terry L. Medley,

Administrator, Animal and Plant Health Inspection Service.

[FR Doc. 97-17672 Filed 7-9-97; 8:45 am]

BILLING CODE 3410-34-U