This section of the FEDERAL REGISTER

contains notices to the public of the proposed

issuance of rules and regulations. The

purpose of these notices is to give interested

persons an opportunity to participate in the

rule making prior to the adoption of the final

rules.

Proposed Rules Federal Register

34113

Vol. 65, No. 103

Friday, May 26, 2000

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection

Service

7 CFR Parts 305 and 319

[Docket No. 98–030–1]

RIN 0579–AA97

Irradiation Phytosanitary Treatment of

Imported Fruits and Vegetables

AGENCY: Animal and Plant Health

Inspection Service, USDA.

ACTION: Proposed rule.

SUMMARY: We are proposing to establish

regulations providing for use of

irradiation as a phytosanitary treatment

for fruits and vegetables imported into

the United States. The irradiation

treatment would provide protection

against fruit flies and the mango seed

weevil. This proposal would provide an

alternative to the currently approved

treatments (various fumigation, cold,

and heat treatments, and systems

approaches employing techniques such

as greenhouse growing) against fruit

flies and the mango seed weevil in fruits

and vegetables.

DATES: We invite you to comment on

this docket. We will consider all

comments that we receive by July 25,

2000.

ADDRESSES: To submit a comment by

postal mail, please send your comment

and three copies to Docket No. 98–030–

1, 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. 98–030–

1.

You may also file comments on this

docket electronically, and review

comments filed electronically, at the

World Wide Web site http://

comments.aphis.usda.gov.

You may read any comments that we

receive by postal mail in our reading

room. The reading room is located in

room 1141 of the USDA 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: For

general program and phytosanitary

issues, contact Donna L. West, Import

Specialist, Phytosanitary Issues

Management, PPQ, APHIS, 4700 River

Road Unit 140, Riverdale MD 20737–

1236; (301) 734–6799. For technical

irradiation issues, contact Dr. Arnold

Foudin, Assistant Director, Scientific

Services, PPQ, APHIS, 4700 River Road

Unit 147, Riverdale, MD 20737–1237;

(301) 734–7710.

SUPPLEMENTARY INFORMATION: 

Background

I. Introduction

II. Critical Control Points: Dose, Dosimetry,

Safeguards

III. Irradiation Doses to Control Fruit Flies

and Seed Weevils in Fruits and Vegetables

IV. Dosimetry and Dose Control Issues

V. Safeguards for Different Irradiation

Situations

VI. Proposed Regulatory Framework for

Irradiation Treatments

VII. Proposed Changes to Fruits and

Vegetables Import Regulations

VIII. Compliance With Executive Orders,

Regulatory Flexibility Act, National

Environmental Policy Act, and Paperwork

Reduction Act

I. Introduction

The Animal and Plant Health

Inspection Service (APHIS) is aware of

growing commercial interest in the use

of irradiation as a treatment for

agricultural products, both for food

safety purposes (to kill pathogens and

retard spoilage) and for phytosanitary

purposes (to destroy plant pests). At

least 38 countries have approved

irradiation treatment of more than 40

foods or groups of related foods. In

Europe more than 28 billion pounds of

food are irradiated annually. With

regard to phytosanitary irradiation

treatments to control plant pests, the

World Health Organization, the

International Plant Protection

Convention, and the North American

Plant Protection Organization have

endorsed the technology as effective and

safe.

In anticipation of requests to allow

the use of irradiation in APHIS’

regulatory programs, we have been

developing policies for evaluating

irradiation methods and have been

evaluating research on the efficacy of

irradiation.

To set a framework for developing

APHIS’ irradiation policy, we published

a notice entitled ‘‘The Application of

Irradiation to Phytosanitary Problems’’

in the Federal Register on May 15, 1996

(61 FR 24433–24439, Docket No. 95–

088–1). Among other things, the notice

discussed how APHIS, in collaboration

with the Agricultural Research Service

(ARS), would evaluate scientific

research to determine the minimum

irradiation doses necessary to kill or

render sterile particular pests associated

with particular articles. The notice

emphasized that minimum dose levels

are important and necessary, but that

dose levels by themselves do not

constitute a complete treatment

schedule or an adequate regulatory

framework. Treatment schedules, in

addition to specifying minimum doses,

may employ irradiation as a single

treatment, as part of a multiple

treatment, or as a component of a

systems approach combined with other

pest mitigation measures. The

regulatory framework for employing

irradiation treatments must also address

system integrity or quality control

issues, including methods to ensure that

the irradiation is properly conducted so

that the specified dose is achieved, and

must address matters such as packaging

or safeguarding of the treated articles to

prevent reinfestation.

This proposed rule discusses these

various issues and how they must be

integrated to achieve effective

irradiation treatments, and then

proposes specific standards for an

irradiation treatment for fruit flies and

the mango seed weevil in imported

fruits and vegetables.

II. Critical Control Points: Dose,

Dosimetry, Safeguards

We have identified three critical

control points in the activities involved

in irradiating imported fruits and

vegetables to prevent the spread of fruit

flies and the mango seed weevil. These

are points where errors will definitely

reduce the long-term effectiveness of the

treatment and where, on the other hand,

correct procedure will ensure effective

treatments.

The three critical control points are:

Dose: The dose of ionizing radiation,

calculated in Gray, must be sufficient to

34114 Federal Register / Vol. 65, No. 103 / Friday, May 26, 2000 / Proposed Rules

1 ‘‘Recommendation Irradiation Dose to Provide

Quarantine Security for Commodities Infested with

Certain Fruit Fly Species,’’ Agricultural Research

Service, April 7, 1995, and corollary APHIS

memoranda. You may request these documents

from the person identified above under FOR

FURTHER INFORMATION CONTACT, or download them

from http://www.aphis.usda.gov/ppd/irrad.

2Reports from many of the researchers cited in

this document are available in a single compilation,

‘‘Proceedings of the Final Research Coordination

Meeting on Use of Irradiation as a Quarantine

Treatment of Food and Agricultural Commodities,

August 27–31 1990’’; published by the International

Atomic Energy Agency; U.S. distributor UNIPUB,

Lanham, MD. Parties interested in irradiation

research reports may also be interested in a huge

bibliography on agricultural irradiation assembled

by the Federal Research Center for Nutrition in

Germany, and available on their Web site at http:/

/www.dainet.de/bfe/english/thmliste.htm.

prevent adult emergence of each species

of fruit fly in fruits and vegetables. Each

dose is set at the lowest level that

achieves this effect; the dose will not

necessarily kill larvae immediately after

treatment. These doses are based on

research conducted by ARS and others,

as discussed below.

It is important that the dose be set at

the lowest effective level for regulatory,

economic, and product quality reasons.

The Food and Drug Administration has

issued regulations providing that fruits

and vegetables may receive up to 1

kiloGray (=1,000 Gray) of irradiation (21

CFR 179.26). This current limit of 1

kiloGray for fruits and vegetables is

significant because industry irradiation

methods can only ensure that all articles

in an irradiated lot receive a guaranteed

minimum dose, at the cost of having

some articles in the lot subjected to two

or three times the minimum dose.

Therefore, to achieve a minimum

absorbed dose of 250 Gray, some articles

in a lot may be subjected to a dose of

750 Gray or more. Obviously, this

encourages us to set the dose at the

minimum effective level to avoid the

possibility of any articles being

subjected to a dose above 1 kiloGray.

Also, the higher the dose, the greater the

cost of the irradiation treatment. Finally,

irradiation causes many fruits and

vegetables to suffer changes in color and

texture that increase at higher doses.

Dosimetry: If establishing the required

dose correctly is the first critical control

point, delivering the expected dose

accurately and consistently is the

second critical control point. Accurate

dosimetry ensures that this happens. An

effective dosimetry system is necessary

to ensure that irradiated articles do in

fact receive the minimum required dose

of ionizing radiation. An inaccurate

dosimetry system that records received

doses as higher than they actually are

could allow survival of fruit flies or

mango seed weevils in treated articles.

An inaccurate dosimetry system that

records received doses as lower than

they actually are could result in doses

exceeding the 1 kiloGray limit, as well

as unacceptable changes in the color

and texture of the fruits and vegetables.

Safeguards: The third critical control

point, safeguards, addresses the

movement and identification of articles

before and after they are irradiated.

There is always a risk that treated

articles may become reinfested with

pests after treatment, and safeguards are

necessary to control this risk. If the

fruits and vegetables are irradiated after

arriving in the United States, safeguards

must also be employed to ensure that

pests do not escape from articles en

route through the United States to the

irradiation facility. Finally, internal

safeguards, such as recordkeeping,

labeling, and monitoring and

enforcement of regulatory requirements,

are necessary to ensure that articles are

not accidentally or intentionally

presented as properly irradiated when

they have not been.

III. Irradiation Doses To Control Fruit

Flies and Seed Weevils in Imported

Fruits and Vegetables

APHIS is now prepared to propose

regulations providing for the use of

irradiation as a phytosanitary treatment

to control 11 species of fruit flies and

one species of seed weevil in imported

fruits and vegetables. Based on

evaluation of research that is

summarized in documents available

upon request,1 APHIS is proposing

irradiation for each species as follows:

FRUIT FLIES AND SEED WEEVILS IN IMPORTED FRUITS AND VEGETABLES

Scientific name Common name Dose (gray)

Bactrocera dorsalis ..................................................................... Oriental fruit fly ........................................................................... 250

Ceratitis capitata ......................................................................... Mediterranean fruit fly ................................................................ 225

Bactrocera cucurbitae ................................................................. Melon fly ..................................................................................... 210

Anastrepha fraterculus ................................................................ South American fruit fly ............................................................. 150

Anastrepha suspensa ................................................................. Caribbean fruit fly ....................................................................... 150

Anastrepha ludens ...................................................................... Mexican fruit fly .......................................................................... 150

Anastrepha obliqua ..................................................................... West Indian fruit fly .................................................................... 150

Anastrepha serpentina ................................................................ Sapote fruit fly ............................................................................ 150

Bactrocera tryoni ......................................................................... Queensland fruit fly .................................................................... 150

Bactrocera jarvisi ........................................................................ (No common name) ................................................................... 150

Bactrocera latifrons ..................................................................... Malaysian fruit fly ....................................................................... 150

Cryptorhynchus mangiferae ........................................................ Mango seed weevil .................................................................... 100

ARS recommended these doses based

on review of available literature,

participation in workshops and

meetings, discussions among ARS

scientists, and verbal and written

comments from numerous stakeholders

and interested parties.

The recommended doses are

sufficient to ensure probit 9 efficacy (a

statistical estimation of 99.99683

percent mortality or sterility,

corresponding to a survival rate of 32

fertile flies or weevils per million). The

doses will almost entirely prevent

emergence of live adults from irradiated

fruits and vegetables.

ARS found sufficient data in its

review of research2 to recommend

irradiation doses for 11 species of

tephritid fruit flies and one species of

seed weevil.

In 1986, minimum doses of 150 and

300 Gray were internationally proposed

for quarantine security of tephritid fruit

flies and all other arthropods,

respectively (Loaharanu 1992). It was

concluded that the dose of 150 Gray

should prevent development of adult

tephritid fruit flies capable of flight

when eggs and larvae are irradiated,

while 300 Gray should cause sterility to

all stages of other insects and mites.

The first calculated estimates of doses

to provide probit 9 security against fruit

fly adult emergence were made by

Balock et al. (1966). The probit 9

Federal Register / Vol. 65, No. 103 / Friday, May 26, 2000 / Proposed Rules 34115

estimate of the irradiation dose that

would prevent the emergence from fruit

of adult Oriental fruit fly, Bactrocera

dorsalis (Hendel), varied from 206 Gray

in papaya to 280 Gray in a combination

of eight different fruits. The fruits tested

in this research ranged in size from

Barbados cherry to tangerine and were

infested with immature stages of the

fruit fly ranging from egg to third instar.

For melon fly, Bactrocera cucurbitae

(Coquillett), combined data on

irradiation of eggs through third instars

in papaya, tomato, and cucumber gave

a probit 9 estimate of 156 Gray. Two

adult Mediterranean fruit flies, Ceratitis

capitata (Wiedemann), emerged from

approximately 1,300 early instar larvae

in papayas treated at 100 Gray.

However, the study’s authors believed

that these two flies resulted from posttreatment infestation because no adults

emerged from papayas infested with

approximately 19,000 early instars and

treated with 25–75 Gray. No estimate of

probit 9 security for C. capitata was

offered. No tests using large numbers of

B. dorsalis or B. cucurbitae were

conducted at the estimated probit 9

doses; therefore, accuracy of these

estimates was not confirmed.

Seo et al. (1973) subjected large

numbers of fruit fly immatures inside

fruits to irradiation doses ranging from

209 to 291 Gray. Doses as high as 244

Gray allowed some B. dorsalis to emerge

as adults; it was not stated whether

these adults were capable of flight. No

irradiated B. cucurbitae immatures

emerged as adults even at doses as low

as 209 Gray. Two adult C. capitata

emerged from an estimated 110,772 C.

capitata immatures irradiated at 225

Gray. It was not mentioned whether

either adult was capable of flight. Based

on this study, Burditt and Seo (1971)

recommended a dose of 210–250 Gray to

prevent adult emergence of these three

flies infesting tropical fruits in Hawaii.

Other studies dealt with irradiation of

fruits infested with B. dorsalis and C.

capitata. Although no adults emerged

from an estimated 18,000 B. dorsalis

third instars irradiated with 150 Gray in

carambolas, emergence was less than 10

percent in the untreated control,

indicating that the pupae were exposed

to severe mortality factors unrelated to

irradiation (Vijaysegaran et al. (1992)).

A dose of 100 Gray prevented adult

emergence of an estimated 131,148, 5- to

6-day-old B. dorsalis immatures

irradiated in 250–300 gram ‘‘Carabao’’

mangoes (Manoto et al. (1992)). Komson

et al. (1992) irradiated an estimated

173,042, 5-day-old B. dorsalis larvae

reared at 27 (+/¥2)°C in ‘‘Nang

Klangwan’’ mangoes with 150 Gray with

one adult survivor. Although no C.

capitata adults emerged from an

estimated 100,854 third instars in

mangoes exposed to 150 Gray, 5 adults

emerged from an estimated 5,268 larvae

irradiated at that same dose in a

previous test (Bustos et al. (1992)).

Bustos et al. (1993) felt that 250 Gray

was required to prevent development of

adult C. capitata from irradiated larvae.

In Australia, various researchers have

irradiated, at 50–100 Gray, a wide

variety of fruits infested with large

numbers of all immature stages of

Queensland fruit fly, Bactrocera tryoni

(Froggatt), with no apparently normal

adult survivors. An estimated total of

566,714 ‘‘old larvae’’ were subjected to

75 Gray in five different fruits with no

normal adult survivors. Heather et al.

(1991) irradiated an estimated 110,935

eggs and 153,814 third instars of

Bactrocera jarvisi (Tryon) in

‘‘Kensington’’ mangoes with 74–100

Gray and obtained no normal adult

survivors.

Large numbers of five species of

Anastrepha in fruits have been

irradiated with doses of 50–150 Gray

with no apparently normal adult

survivors. However, von Windeguth

(1986) found one apparently normal

adult A. suspensa from an estimated

25,363 third instars in mangoes

irradiated with 55 Gray.

Cherries infested with western cherry

fruit fly, Rhagoletis indifferens Curran,

were irradiated with a mean dose of 97

Gray, and one adult with vestigial wings

emerged out of an estimated 15,812

immatures (Burditt and Hungate (1988)).

APHIS bases its proposed irradiation

doses on the pertinent literature. The

doses vary according to species, because

the resistance of species varies. We

propose to require a minimum dose of

250 Gray for B. dorsalis based on the

study of Seo et al. (1973), who obtained

17 adults from a total of 490,289 larvae

in papaya irradiated at a minimum dose

of 244–252 Gray. At lower doses (214–

225 Gray) in papaya, 5 of a total of

306,431 immatures developed to adults.

Given the data of Seo et al. (1973), a

dose of 250 Gray for B. dorsalis appears

marginally effective at producing probit

9 security. However, it seems that the

high survival rate at a dose of 244 Gray

was atypical (17 adults emerged from

130,156 immature forms irradiated with

244 Gray), given that the study showed

that fewer adults emerged at lower

doses. No adults emerged when 155,903

immature forms in papayas were

irradiated with 214 Gray. The only other

large-scale studies with B. dorsalis used

very high infestation levels and

included few third instars, which may

have reduced tolerance of the insects to

irradiation (Komson et al. (1992);

Manoto et al. (1992)).

We propose a minimum dose of 225

Gray for C. capitata. At 225 Gray, 2 of

an estimated 110,772 C. capitata larvae

completed development to the adult

stage (Seo et al. (1973)). Furthermore,

although no larvae of an estimated

100,854 third instar C. capitata in

mangoes irradiated with 150 Gray

became adults, the fact that 5 of 5,268

larvae did in an earlier test cannot be

ignored (Bustos et al. (1992)).

We propose a minimum dose of 210

Gray for B. cucurbitae because at a dose

of 209 Gray no B. cucurbitae larvae of

an estimated 169,903 in bell peppers

reached the adult stage (Seo et al.

(1973)). The study’s authors did not test

lower doses, and no other studies using

large numbers of B. cucurbitae have

been conducted.

We propose a minimum dose of 150

Gray for eight other tephritid fruit flies:

B. tryoni, B. jarvisi, B. latifrons, A.

fraterculus, A. suspensa, A. serpentina,

A. ludens, and A. obliqua. Although the

research evidence shows that lower

doses might suffice, a dose of 150 Gray

should pose no greater problem to

irradiation-tolerant commodities

compared with lower doses, and it

provides greater security.

We propose a minimum dose of 100

Gray for the mango seed weevil,

Cryptorhynchus mangiferae, because

research by ARS (Follett, 1999) has

demonstrated that the weevils are

effectively killed or sterilized at this

dose.

IV. Dosimetry and Dose Control Issues

It is critical to ensure that articles

actually receive the required dose

during irradiation, since lower doses

could allow pests to survive.

Fortunately, the irradiation industry and

researchers have spent decades

developing and documenting effective

systems for dosimetry. We are confident

that facilities that correctly apply

dosimetry guidance published by the

American Society for Testing and

Materials (ASTM) will be able to

reliably measure the doses regulated

articles receive.

The basic product delivered by

businesses engaged in irradiation is an

accurately measured dose of ionizing

radiation, within the range requested by

the customer, delivered to articles

provided by the customer. Therefore,

dosimetry is an integral part of these

businesses’ procedures, and APHIS does

not need to address dosimetry in detail

in this proposal, other than to require

that the businesses follow good

dosimetry practices to map, control, and

record the radiation dose. Guidance and

34116 Federal Register / Vol. 65, No. 103 / Friday, May 26, 2000 / Proposed Rules

requirements for dosimetry by ASTM,

the U.S. Department of Energy, and

APHIS, and supervision by responsible

national agencies in foreign countries,

establish the degree of dosimetry

reliability needed to make this proposal

work.

V. Safeguards for Different Irradiation

Situations

Safeguards reduce risk by controlling

the movement and identification of

articles before and after they are

irradiated. Safeguards include such

matters as packaging, labeling, records,

and irradiation facility construction and

procedures. The types of safeguards

needed to reduce risks will change with

changing conditions. Certain safeguards

are needed if the irradiation facility is

located in an area infested with fruit

flies, or if irradiated commodities

leaving the facility en route to the

United States will transit such an area

where the risk is high that flies could

oviposit in fruit after it is irradiated.

These identical safeguards would not be

needed if the irradiation takes place in

an area not infested with fruit flies.

The actual safeguards needed for

different situations are discussed below

under ‘‘Proposed Regulatory Framework

for Irradiation Treatments.’’ The goal of

the safeguards is to address risks that

are not fully addressed by the technical

irradiation components of this proposal.

Such risks include misidentification of

articles so that untreated cartons are

delivered labeled as treated,

reinfestation of treated articles after

treatment, and escape of fruit flies from

articles in the United States prior to

treatment.

Most of the safeguards we are

proposing are based on previous

operational experience that shows these

safeguards to be effective when required

to import fruits and vegetables that are

subject to a variety of treatments under

our regulations (e.g., fumigation, hot

water dips, cold treatments). For

instance, many existing treatments

require the treated articles to be packed

in insect proof cartons after treatment,

and require labeling to distinguish

treated from untreated cartons. The

proposed safeguards concerning the

allowed locations of irradiation facilities

in the United States, and the routes

untreated articles may follow to these

facilities, are based on operational

experience showing that the pests of

concern cannot become established in

the climate prevailing in the States

where irradiation facilities would be

allowed. The safeguards concerning

records that irradiation facilities would

have to keep (concerning 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) are based on

procedures the irradiation industry has

endorsed and found effective in

documenting that various irradiated

articles (e.g., medical supplies) receive

the required dose of irradiation.

VI. Proposed Regulatory Framework

for Irradiation Treatments

As discussed above, we have

proposed, based on research data, the

doses of radiation for imported fruits

and vegetables that effectively prevent

the emergence of living adult forms of

11 species of fruit flies and one species

of seed weevil. The above discussion

also explains how we propose to

measure and verify delivery of the

effective doses and that safeguards may

be needed to prevent pest escape from

products before treatment and

reinfestation after treatment. These

elements of irradiation treatment fit into

the existing APHIS regulatory structure

as follows.

First, we propose to establish a new

part 305 in title 7 of the Code of Federal

Regulations. The new part 305 would be

titled ‘‘Phytosanitary Treatments.’’ At

this time, this part would contain only

the irradiation treatment schedules and

procedures for treatment for 11 species

of fruit flies and one species of seed

weevil in fruits and vegetables. In the

future, APHIS may add more of its

existing and new treatments to part 305

to make it easier for customers to find

treatments and to simplify crossreferences in our regulations.

In addition to establishing a new part

305 to contain the irradiation treatment

schedules, we also propose to make

changes to ‘‘Subpart—Fruits and

Vegetables’’ (7 CFR 319.56 through

319.56–8) to authorize the importation

of articles irradiated in accordance with

the new part 305.

New part 305 would also specify

requirements for irradiation facilities

performing the irradiation. These

requirements would include procedures

for approving the facility, monitoring

facility operations, recordkeeping,

dosimetry, and packaging of fruits and

vegetables treated at the facility. These

requirements in the new part 305 would

be similar to existing APHIS regulations

concerning irradiation treatments. These

include regulations for moving

regulated articles interstate from

Mediterranean fruit fly quarantined

areas (7 CFR 301.78–10), and

regulations for moving certain fruits and

vegetables interstate from Hawaii (7 CFR

318.13–4f).

Proposed § 305.1 would set forth

definitions of the terms Administrator,

APHIS, Dose mapping, Dosimetry, and

Dosimetry system. The first two terms

would use the same definitions

commonly in use in other APHIS

regulations. The final three terms would

use definitions consistent with accepted

nuclear industry use of those terms.

Proposed § 305.2(a) would set forth

the common and scientific names of the

fruit flies and seed weevil for which

irradiation treatment is authorized and

the dose in Gray required for each

species.

Proposed § 305.2(b) would allow

irradiation to be conducted prior to the

arrival of articles in the United States,

or after arrival, but would limit the

location of facilities in the United States

to certain northern States where the

climate would preclude the successful

establishment of the targeted fruit flies,

i.e., 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, and Virginia. We

propose this location restriction as a

safeguard against the possibility that,

despite container and movement

restrictions designed to prevent this

possibility, fruit flies could escape from

regulated articles in the United States

prior to treatment. Paragraph (b) also

would provide that fruits and vegetables

to be irradiated may not move into or

through the States listed above prior to

treatment, except that Dallas/Fort

Worth, TX, would be an authorized stop

for air cargo or 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. Dallas/Fort Worth would

be an exception because the

transloading facility at the airport is

under USDA supervision, and both the

facility procedures and the climate and

host material in the immediate area

minimize the risk that fruit flies could

escape and become established.

This geographic restriction of

irradiation facilities to States where fruit

flies would not survive the winter may

be reevaluated later if evidence from

irradiation operations shows the risk of

fruit fly escape and spread from the

facilities to be insignificant.

Proposed § 305.2(c) and (d) would

require that facilities conducting

authorized irradiation treatments, and

importers moving articles to such

facilities in the United States, must do

so under a compliance agreement with

APHIS.

Federal Register / Vol. 65, No. 103 / Friday, May 26, 2000 / Proposed Rules 34117

Proposed § 305.2(e) would require

that facilities conducting irradiation

treatments be certified by the

Administrator of APHIS. Certification

would not expire after a fixed time;

however, a facility would have to be

recertified after an increase or decrease

in radioisotope, natural deterioration of

the radioisotope, a major modification

to equipment that affects the delivered

dose, or a change in the owner or

manager of the facility. Recertification

also may be required in cases where a

significant variance in dose delivery has

been measured by the dosimetry system.

In order to be certified, a facility

would have to be capable of

administering the minimum absorbed

ionizing radiation doses and be

constructed according to specified

standards so that treated and untreated

fruits and vegetables are kept in separate

locations with a physical barrier

between them to prevent the transfer of

cartons. Treated and untreated fruits

and vegetables could be separated with

barriers such as a 6-foot wall or chain

link fence to minimize interference with

facility operations and visibility.

It might seem that an insect proof

barrier should separate the areas for

untreated and treated articles.

Obviously, a chain link barrier would

not prevent flies from emerging from

fruits on the untreated side, flying to the

treated side, and leaving the facility in

fruit that has been irradiated. However,

we believe an insect proof barrier in the

facility is unnecessary because it is

extremely unlikely that fruit and

vegetable shipments, moved by air

freight and irradiated on speedy

industrial schedules, would be around

long enough prior to treatment for fruit

flies to hatch, emerge, and spread to the

untreated side of the facility. Larvae and

pupae, if any are present in the articles,

are not mobile enough to move from

untreated cartons to treated cartons.

Adult flies are unlikely to be present

with commercial fruit, which is usually

shipped before it is fully ripe. Therefore,

an insect proof barrier separating the

facility areas for treated and untreated

articles is not needed.

Another safeguard in proposed

§ 305.2(e) provides that a facility in the

United States would only be approved

to irradiate imported regulated articles if

the Administrator determines that

regulated articles would be safely

transported to the facility from the port

of arrival without diversion to any other

destination, and without significant risk

that plant pests will escape in transit or

while the regulated articles are at the

facility. The compliance agreement for a

facility located in the United States

would require the facility to comply

with additional requirements to prevent

escape of plant pests from the articles

prior to their treatment. One of these

requirements would be prompt

irradiation of the fruits and vegetables to

minimize the risk that fruit flies could

emerge from the articles and spread to

treated articles and reinfest them.

Proposed § 305.2(f) concerns

monitoring of treatments. Treatment in

U.S. and foreign facilities would have to

be monitored by an APHIS inspector,

who would also inspect treatment

records and make unannounced

inspections of the facility. We propose

to require facilities that carry out

continual irradiation operations to

notify an inspector at least 24 hours

before the date operations commence.

Facilities that carry out periodic

irradiation operations would have to

notify an inspector at least 24 hours

before scheduled operations.

We believe this level of monitoring is

necessary to ensure that irradiation is

effectively conducted. Monitoring and

verification are extremely important to

ensure the integrity of the entire system

for irradiating imported fruits and

vegetables. This is because there is no

practical way for an inspector to

determine, based on physical evidence

from the commodity itself, that a

commodity has been irradiated.

Irradiation leaves no residue and

usually causes no discernable change to

the commodity’s color or texture. In

addition, an effective irradiation

treatment may not kill all larvae, but

instead might prevent adult emergence.

In cases where an inspector at the port

of arrival encounters live larvae of the

target pest in a shipment that is

documented as irradiated, it is

extremely important that the

documentation and procedures of the

irradiation treatment system allow the

inspector to determine with full

confidence that the commodity was

properly treated according to APHIS

requirements.

Proposed § 305.2(g) prescribes

requirements for the packaging of

irradiated fruits and vegetables.

First, all irradiated fruits and

vegetables must be shipped in the same

cartons in which they are irradiated,

and no irradiated fruits or vegetables

may be shipped in the same carton with

nonirradiated fruits and vegetables. This

is to prevent confusion as to the

treatment status of the articles.

In addition, fruits and vegetables

irradiated before arrival in the United

States would have to be packaged as

follows:

The cartons must be insect proof

unless the treated fruits and vegetables

are stored in an insect proof room after

irradiation and are wrapped on their

pallets in insect proof polyethylene,

shrink wrap, or fine netting before being

shipped to the United States. If insect

proof cartons are employed, they may

have no openings that could allow the

entry of fruit flies, and must be sealed

with seals that will visually indicate if

the cartons have been opened. The

cartons may be constructed of any

material that prevents the entry of fruit

flies and prevents oviposition by fruit

flies into the articles in the carton.

We also propose the following pallet

security requirement for articles

irradiated prior to arrival in the United

States, regardless of whether insect

proof cartons are employed. In order to

ensure that no cartons are added to or

removed from a pallet load of cartons

containing irradiated fruits or

vegetables, pallet loads would have to

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 propose to require that

pallet loads of irradiated fruits and

vegetables be marked with irradiation

lot numbers, packing and irradiation

facility identification and locations, and

dates of packing and irradiation. If the

pallet load is broken down into smaller

units before or during the process of

entering the United States, the

individual cartons would have to be

labeled with this information. This

information would allow an inspector to

identify the irradiation lots and trace

them back to the packing and irradiation

facilities. While this labeling imposes

some burden on the importer, some of

the information, e.g., identification of

the packer, is already normally required

for imported fruits and vegetables, and

irradiation facilities routinely label

treated articles with the identity of the

irradiation facility, the lot number, and

the treatment date upon request. This

labeling is normally done for each

pallet, but other arrangements may be

made if the pallet is to be broken into

smaller units prior to entry into

commerce in the United States.

Irradiation facilities have indicated that

they can work with customers to

minimize the cost and inconvenience of

such labeling, e.g., by providing

customers with preassigned lot numbers

so they can be printed on the cartons

along with the packer’s name.

We are not proposing any special

packaging requirements for articles to be

irradiated in facilities in the United

States. Untreated fruits and vegetables

imported for irradiation in the United

States may be packed in ventilated

34118 Federal Register / Vol. 65, No. 103 / Friday, May 26, 2000 / Proposed Rules

3 Kader, A.A., 1986. ‘‘Potential Applications of

Ionizing Radiation in Postharvest Handling of Fresh

Fruits and Vegetables,’’ Food Technology, v. 40, no.

6, June 1986.

cartons that are not insect-proof. The

cartons will generally be imported in

shipping containers that are not opened

until they reach the facility, and

importers must sign compliance

agreements with APHIS that will ensure

against diversion of the shipment to a

destination other than treatment, and

against possible releases of fruit flies en

route. No additional packing

requirements appear necessary because

the articles are destined for irradiation

facilities in States where fruit flies

cannot become established and spread.

Proposed § 305.2(h) concerns

dosimetry requirements. We propose to

require that absorbed dose be measured

at the treatment facility using a

dosimetry system that can accurately

measure a minimum absorbed dose of

150, 210, 225, and 250 Gray, to match

the required doses for the relevant

species of fruit fly. We would require

that the dosimetry system, including the

number and placement of dosimeters

used at the facility to measure the

absorbed dose, be in accordance with

standards of the American Society for

Testing and Materials (ASTM). (See

Designation E 1261–94, ‘‘Standard

Guide for Selection and Calibration of

Dosimetry Systems for Radiation

Processing,’’ American Society for

Testing and Materials, Annual Book of

ASTM Standards.)

We considered proposing to require

that each carton or other container of

fruits or vegetables contain a radiation

indicator that is placed in the carton or

other container prior to irradiation and

remains in place until after the fruits

and vegetables have entered the United

States. Such indicators, in the form of

chemically impregnated stickers that

change color after exposure to specified

levels of ionizing radiation, are

inexpensive and are in common use on

cartons of medical supplies irradiated

for sterility. This requirement would

assist our inspectors by providing them

with a tool to determine that a particular

carton has been irradiated. Using such

an indicator would also be a safeguard

against fraudulent representations in

paperwork that articles had been

irradiated when they had not.

However, we have decided not to

propose such a requirement at this time,

for the following reasons. There are no

indicator stickers currently on the

market that change color in the 150–250

Gray range proposed in this document;

the medical products indicators

mentioned above react in the 1 kiloGray

range. Also, such indicators are not

accurate dosimeters and may in fact

change color when exposed to

conditions other than irradiation

treatment (e.g., intense sunlight or

temperature changes). While further

developments may eventually make

such indicators useful for monitoring

compliance with irradiation

requirements for fruits and vegetables,

we do not believe they would be useful

now.

Proposed § 305.2(i) would require the

treatment facility to maintain records of

treatment for 1 year after each lot is

treated. We would require the records to

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. All records would

have to be available for review by

APHIS inspectors during normal

business hours. These detailed records

are necessary to ensure system integrity

for irradiation treatments and for

successful enforcement of the

regulations and identification of

fraudulent documents or other

violations. We believe that all of these

records are already kept by irradiation

facilities, either as normal business

practice or as required by the Nuclear

Regulatory Commission or State

agencies.

Proposed § 305.2(j) and (k) describe

how a person would request

certification by APHIS of an irradiation

facility, and how such certification

could be denied or withdrawn by the

Administrator.

Proposed § 305.2(l) states that the

Department of Agriculture and its

inspectors assume no responsibility for

any loss or damage resulting from

irradiation treatment. From the

literature available, we believe the fruits

and vegetables authorized for treatment

under this section are tolerant to the

minimum absorbed dose required by the

treatment. However, the facility operator

and shipper would be responsible for

determination of tolerance. This

paragraph also briefly describes the

responsibilities of the Nuclear

Regulatory Commission and the Food

and Drug Administration in regulating

irradiation facilities.

Damage to treated commodities is a

significant issue for importers. In fact,

one reason there is interest in

irradiation treatments is that the

treatment is effective against fruit flies

in a number of tropical fruits and other

articles that do not survive other

treatments well; e.g., papaya, rambutan,

carambola, litchi. Some research has

shown changes to fruit color and texture

when they are irradiated at several times

the required minimum dosage. This

could be a problem because some

irradiation facilities may subject the

articles to two to three times the

required minimum dose—either to

ensure that all articles in a treated lot

(both those nearest to and farthest from

the radiation source) receive at least the

required minimum dose, or because it is

simply infeasible to expose the articles

to the radiation source and then remove

them quickly enough to achieve only

the minimum required dose.

To illustrate this dose range problem,

consider that, in a typical irradiation

facility fruits may be treated while they

are stacked in cartons on 4-by-4 foot

pallets. When these stacks are exposed

to the radiation source, an exposure

long enough to result in the minimum

required dose for the fruit in the center

of the stack will result in a significantly

higher dose for fruit on the outside of

the stack, even if the stacks are rotated

during irradiation. Also, some minimum

required doses are so small that an

entire stack of pallets need be exposed

to the radiation source for 1 minute or

less, but it is very difficult to move the

stack of pallets through the irradiation

chamber quickly enough to achieve only

the minimum dose.

Therefore, persons using irradiation

treatments on their commodities should

pay close attention to the studies of

effects on commodity quality of

radiation doses over the level required

by APHIS, and should understand the

procedures employed by the irradiation

facility and work with the facility to

avoid doses that might negatively affect

quality.

The following table 3 is presented to

give some idea of the relative tolerances

to irradiation of different fruits and

vegetables.

IRRADIATION DOSES BELOW 1 KILOGRAY.—RELATIVE TOLERANCES OF FRUITS AND VEGETABLES

High .................................... Apple, cherry, date, guava, longan, muskmelon, nectarine, papaya, peach, rambutan, raspberry, strawberry,

tamarillo, tomato.

Federal Register / Vol. 65, No. 103 / Friday, May 26, 2000 / Proposed Rules 34119

IRRADIATION DOSES BELOW 1 KILOGRAY.—RELATIVE TOLERANCES OF FRUITS AND VEGETABLES—Continued

Medium ............................... Apricot, banana, cherimoya, fig, grapefruit, kumquat, loquat, litchi, orange, passion fruit, pear, pineapple, plum,

tangelo, tangerine.

Low ..................................... Avocado, cucumber, grape, green bean, lemon, lime, olive, pepper, sapodilla, soursop, summer squash, leafy

vegetables, broccoli, cauliflower.

This table should not be considered

authoritative, as many variables affect

radiation tolerance. For example,

although grapes are considered to have

low tolerance, in the past year grapes

have been irradiated and moved from

the Medfly-quarantined area in Florida,

in accordance with § 301.78–10, without

apparent effects on the quality of the

fruit.

VII. Proposed Changes to the Fruits and

Vegetables Import Regulations

As discussed above, in addition to

establishing a new part 305 to contain

the irradiation treatment requirements,

this proposal would also make changes

to the regulations to authorize the

importation of fruits and vegetables

using those treatments.

Regulations for importing fruits and

vegetables are contained in ‘‘Subpart—

Fruits and Vegetables’’ (7 CFR 319.56

through 319.56–8).

APHIS intends that irradiation, where

available, may be substituted for, or

used in conjunction with, any other

treatment or special growing and

handling conditions (systems approach)

required by ‘‘Subpart—Fruits and

Vegetables’’ or the Plant Protection and

Quarantine Treatment Manual to

mitigate the risk associated with any of

the 11 species of fruit flies and one

species of seed weevil named in this

proposal. The fruits and vegetables

regulations cover a large number of

importation scenarios, and the

requirements of the regulations depend

on the risks presented by the particular

article being imported. Fruits or

vegetables imported from an area with

no significant pests of concern may be

imported without any treatment, subject

only to inspection upon arrival. At the

other extreme, fruits or vegetables

imported from an area with several

significant pests might have to undergo

several different treatments to be

eligible for importation.

‘‘Subpart—Fruits and Vegetables’’

contains a number of administrative

instructions in §§ 319.56–2a through

319.56–2ee that specify unique

combinations of treatments, procedures,

and other tailored requirements to allow

the safe importation of various articles.

However, in recent years our policy has

been to list most articles under one of

two sections. Section 319.56–2t lists

articles that may be imported from

various foreign locations without any

required treatment, subject to inspection

and other activities at the port of arrival.

Section 319.56–2x lists articles that may

be imported from various foreign

locations only if they have been treated

in accordance with the Plant Protection

and Quarantine (PPQ) Treatment

Manual, which is incorporated into the

regulations by reference at 7 CFR 300.1.

The PPQ Treatment Manual includes

a number of fumigation, cold, and heat

treatments to control the 11 species of

fruit flies and one species of seed weevil

that APHIS has determined can be

controlled by irradiation of fruits and

vegetables. Therefore, we propose to

amend § 319.56–2x to state that the

listed articles may be imported only if

they have been either: (1) Treated in

accordance with the PPQ Treatment

Manual, or (2) treated by irradiation in

accordance with 7 CFR part 305 if

treatment is required by the PPQ

Treatment Manual for one or more of

the 11 species of fruit flies and one

species of seed weevil listed in part 305.

There are also sections of ‘‘Subpart—

Fruits and Vegetables’’ other than

§ 319.56–2x that require that some fruits

and vegetables be treated or subjected to

special growing and handling

conditions (a systems approach) for fruit

flies. For example, § 319.56–2h requires

fumigation of grapes from Australia for

several pests, including two fruit flies.

Section 319.56–2k prescribes fumigation

of grapes from many countries, and the

pests of concern for this section are

often fruit flies. Therefore, we also

propose to add a new paragraph (k) to

§ 319.56–2 to allow substitution of

irradiation for fruit fly treatments or

systems approaches that are required by

any section in ‘‘Subpart—Fruits and

Vegetables.’’ New paragraph (k) would

read ‘‘Any fruit or vegetable that is

required by this subpart or the Plant

Protection and Quarantine Treatment

Manual to be treated or subjected to

other growing or inspection

requirements to control one or more of

the 11 species of fruit flies and one

species of seed weevil listed in

§ 305.2(a) of this chapter as a condition

of entry into the United States may

instead be treated by irradiation in

accordance with part 305 of this

chapter.’’

For example, § 319.56–2x currently

allows importation of grapefruit and

oranges from Mexico if they are treated

in accordance with the PPQ Treatment

Manual, which requires a cold treatment

(T107) of these commodities for several

species of fruit fly that attack grapefruit

and oranges in Mexico. Because these

species of fruit fly are among the 11

species listed in proposed part 305,

grapefruit and oranges from Mexico

could be imported subject to irradiation

treatment instead of the cold treatment.

Another example where irradiation

treatment could be substituted would be

kiwis and tangerines from Greece.

Currently, the PPQ Treatment Manual

requires either a cold treatment

(T107(a)) or fumigation plus

refrigeration (T108(a)) to control fruit

flies in these articles from Greece. An

example of a scenario where treatment

for fruit flies is required by a different

section of ‘‘Subpart—Fruits and

Vegetables’’ would be grapes imported

from Algeria under § 319.56–2k; if fruit

flies are the only pest in that country

requiring precooling and fumigation

under § 319.56–2k, the grapes would be

allowed to enter the United States if

they receive an irradiation treatment

instead. Another scenario under which

the proposed irradiation treatment

could be used in lieu of current

regulatory requirements would be the

current importation of pink or red

tomatoes from Spain in accordance with

§ 319.56–2dd. To prevent the

introduction of Mediterranean fruit fly,

§ 319.56–2dd imposes various

requirements including greenhouse

growing of the tomatoes, fruit fly

trapping surveys in the greenhouse area,

and shipping only during winter and

early spring months. If this proposal is

adopted, shippers of pink and red

tomatoes from Spain could choose to

irradiate them rather than meet the

requirements of § 319.56–2dd.

These are examples of the simplest

scenario under the present proposal,

i.e., importing articles when the only

pests of concern are one or more of the

11 species of fruit flies. However,

sometimes other pests that attack the

articles will be present in the place of

origin. If the regulations or the PPQ

Treatment Manual require the article to

be treated for these additional pests, the

articles must receive any additional

required treatment, in addition to

irradiation for fruit flies or mango seed

weevils.

34120 Federal Register / Vol. 65, No. 103 / Friday, May 26, 2000 / Proposed Rules

4 ‘‘Costs and Benefits of Irradiation Versus Methyl

Bromide Fumigation for Disinfestation of U.S. Fruit

and Vegetable Imports,’’ by Kenneth W. Forsythe,

Jr. and Phylo Evangelou, ERS Staff Report No.

AGES 9412, March 1994.

The proposed irradiation doses are

specific to the identified species of fruit

fly or seed weevil but generic for the

commodity. Any fruit or vegetable may

be treated at the dose prescribed for the

fruit fly of concern. The treatment for

the fruit fly requiring the highest dose

would be required when more than one

species of fruit fly is a pest of concern.

VIII. Compliance With Executive

Orders, Regulatory Flexibility Act,

National Environmental Policy Act, and

Paperwork Reduction Act

Executive Order 12866 and Regulatory

Flexibility Act

This proposed rule has been reviewed

under Executive Order 12866. The rule

has been determined to be significant

for the purposes of Executive Order

12866 and, therefore, has been reviewed

by the Office of Management and

Budget.

The economic analysis for the

changes proposed in this document is

set forth below. It provides a costbenefit analysis as required by

Executive Order 12866 and an analysis

of the potential economic effects on

small entities as required by the

Regulatory Flexibility Act.

In accordance with 5 U.S.C. 603, we

have performed an initial regulatory

flexibility analysis regarding the effect

of this proposed rule on small entities.

Because we do not currently have all the

data necessary for a comprehensive

analysis of the effects of this rule on

small entities, we are inviting comments

concerning potential effects. In

particular, we are interested in

determining the number and kind of

small entities that may incur benefits or

costs from implementation of this

proposed rule.

Under the Federal Plant Pest Act (7

U.S.C. 150aa–150jj) and the Plant

Quarantine Act (7 U.S.C. 151–165 and

167), the Secretary of Agriculture is

authorized to regulate the importation of

plants, plant products, and other articles

to prevent the introduction of injurious

plant pests.

This proposed rule would permit the

treatment of imported fruit and

vegetables by irradiation, in place of or

in conjunction with existing

phytosanitary treatments or other

protocols, for 11 species of fruit flies

and one species of seed weevil.

Irradiation could take place prior to

shipment to the United States or after

arrival. There would be requirements for

certification of the facilities, treatment

monitoring, pallet security, and

recordkeeping for irradiation at all

facilities, and packaging and labeling

requirements for articles irradiated

before arrival in the United States.

Irradiation facilities would have to use

an approved dosimetry system during

treatment and keep records to verify

effective irradiation. For irradiation after

arrival, compliance agreements would

impose requirements on the transit from

ports to irradiation facilities, to ensure

all shipments requiring irradiation are

delivered to the facility and are not

rerouted to sale prior to treatment.

Firms in the United States primarily

affected by this proposed rule would be

ones conducting the irradiation

treatments. They could be variously

classified by the Small Business

Administration, depending on each

one’s particular business enterprises. A

firm providing irradiation services

strictly for the treatment of crops,

including imported fruits and

vegetables, would be included in the

Standard Industry Classification (SIC)

category 0723 (Crop Preparation

Services, except Cotton Ginning). A firm

would qualify as a small entity if it had

annual revenues of $5 million or less. If

a firm that imports or wholesales fruits

and vegetables were to perform the

irradiation itself, it would be included

in SIC 5148 (Fresh Fruits and

Vegetables), since its principal activity

would remain importing or wholesaling.

In this case, the firm would be

designated as a small entity if it had 100

or fewer employees.

Firms expected to benefit most

immediately from this proposed rule,

however, would not belong in either of

these SIC categories. They would be

companies that currently provide

irradiation services on contract for

decontamination or sterilization

purposes and could readily adapt to

perform phytosanitary irradiation. They

are classified within SIC 2099 (Food

Preparations, N.E.C.) or SIC 2842

(Specialty Cleaning, Polishing, and

Sanitation). The former category

includes firms that irradiate food items,

such as spices, seeds, culinary herbs,

vegetable seasoning, and poultry, to

destroy harmful pathogens. Included in

SIC 2842 are firms that primarily

provide irradiation services for the

sterilization of medical devices,

pharmaceutical preparations, and raw

materials used in cosmetic products.

Four firms with SIC 2099 or 2842

designations have been identified that

provide irradiation services on contract.

For both categories, employment of 500

or fewer persons qualifies a firm as a

small entity. Three of the four firms are

considered small. (The fourth one had

been a small entity until last year, when

it was purchased by another

corporation.)

Of these four companies, the one that

is not a small entity is the only one

engaged at present in phytosanitary

irradiation. This firm treats papayas,

carambolas, litchis, and other tropical

fruits from Hawaii that are moved

interstate to the mainland United States.

Irradiation of the fruit in accordance

with 7 CFR 318.13–4f, performed at

facilities in Illinois, removes the risk of

Mediterranean, Oriental, and melon

fruit fly introduction, while also

lengthening the shelf life of the fruit.

Treatment of the Hawaiian fruit,

however, is a small part of the firm’s

business; irradiation services are mainly

provided for sterilization purposes

through a network of facilities in nine

States and Canada.

Similarly, the second of the four firms

has 12 facilities throughout the United

States, 8 of which are used for medical

sterilizations and 4 for other purposes.

One of the 12 facilities, located in

southern California, has been adapted

for irradiation of fruits and vegetables

for the purpose of lengthening shelf life.

The other two firms that provide

irradiation services are single-facility

businesses. One, in Maryland,

principally conducts medical and

pharmaceutical sterilizations, and the

other, in Florida, has been irradiating

poultry products for the retail market

and hospitals since 1993.

In addition to these four firms,

companies that use irradiation to

sterilize their own products could also

benefit from this proposed rule by

contracting their irradiation facilities for

phytosanitary purposes. Location,

throughput capacity, the irradiating

processes used, and other characteristics

of the facilities would help determine

whether the cost of their services would

be competitive in comparison to the cost

of alternative methods of treatments.

While these firms are technologically

capable of taking advantage of treatment

opportunities afforded by this proposed

rule, any economic effects on them will

ultimately depend on the cost

effectiveness of irradiation when

compared to alternative phytosanitary

treatments. A 1994 study sheds light on

the benefits and costs of irradiation

versus methyl bromide (MB) fumigation

for the treatment of imported fruits and

vegetables.4 Economic benefits in this

study were estimated in terms of

preventing potential economic losses in

U.S. fruit and vegetable markets that

would result from discontinuation of

MB as a fumigant for imports. In fiscal

Federal Register / Vol. 65, No. 103 / Friday, May 26, 2000 / Proposed Rules 34121

5 ‘‘Quarantine Uses of Methyl Bromide by the

United States, Fiscal Year 1996’’ (Draft), APHISPPD-PAD, April 1997; available in the APHIS

reading room (see ADDRESSES).

6To adjust irradiation unit costs estimated in the

1994 study from 1987 dollars to 1998 dollars,

values are multiplied by a factor of 1.23 (producer

price index for capital equipment, series ID:

WPSSOP3200, Bureau of Labor Statistics, U.S. Dept.

of Labor).

7Ten percent of methyl bromide used annually in

agriculture in the United States is for commodity

and quarantine treatment, compared to 85 percent

for soil fumigation and 5 percent for structural

fumigation. The 1999 Omnibus Consolidated and

Emergency Supplemental Appropriations Act

(Public Law 105–277) made specific changes to the

Clean Air Act, to harmonize the U.S. phaseout of

methyl bromide with the Montreal Protocol

phaseout schedule for developed countries. This

schedule requires U.S. methyl bromide production

and importation reductions (from 1991 levels) of 25

percent in 1999, 50 percent in 2001, 70 percent in

2003, and 100 percent in 2005; exempted from this

phaseout schedule are critical agricultural,

emergency, and preshipment and quarantine uses.

With respect to traded commodities, the

amendment states that ‘‘the [EPA] Administrator

shall exempt the production, importation, and

consumption of methyl bromide to fumigate

commodities entering or leaving the United States

or any State (or political subdivision thereof) for

purposes of compliance with Animal and Plant

Health Inspection Service requirements * * * ’’

(www.epa.gov/ozone/mbr/mbrqa.html).

8The 11 fruits are apricot, banana/plantain,

grapefruit, orange, papaya, peach/nectarine,

pineapple, plum, strawberry, tangerine, and tomato.

The combined weight of import shipments of these

fruits that were fumigated with MB in fiscal year

1996 was approximately 78.3 million pounds. This

represented only 2.43 percent, by weight, of total

imports of these 11 fruits (see, op. cit., ‘‘Quarantine

Uses of Methyl Bromide by the United States, Fiscal

Year 1996’’ [Draft], Table 1). The range of costs is

probably underestimated, since it assumes

economies of size would be captured in all cases.

year 1996, 14 percent of imported fruits,

nuts, and vegetables, valued at about

$345 million, were treated with MB, 80

percent at U.S. ports and 20 percent in

preclearance programs in foreign

locations.5 Although temperaturemodifying treatments are possible

alternatives for some fruits and

vegetables, MB fumigation is the

principal, and sometimes sole,

phytosanitary treatment available for

many commodities.

The 1994 study focused on short-and

medium-term costs and benefits of

irradiation treatment in off-season U.S.

import markets for grapes, nectarines,

okra, peaches, and plums. Grapes

comprise over 80 percent, by value, of

imported fruits and vegetables

fumigated with MB, but they have a low

tolerance for irradiation. When grapes

were included in the analysis,

irradiation treatment costs, in 1998

dollars, ranged from 1.6 to 3.9 cents per

pound. Excluding grapes, irradiation

cost estimates ranged from 3.4 to 3.9

cents per pound.6 These unit costs

reflect the substantial economies of size

that could be captured by irradiation

facilities, due to the concentration of

imported fruit at certain ports of arrival.

Preshipment and quarantine uses of

MB, along with critical agricultural and

emergency uses, are exempted from the

MB phaseout required by the Clean Air

Act.7 These exemptions essentially

segment the MB market into restricted

and unrestricted parts. Demand for MB

used for exempted purposes is expected

to remain unaffected as its use as a soil

fumigant is restricted. However,

reduced production due to the phaseout

may cause the price of MB used for

phytosanitary purposes to rise, due to

an increase in the unit cost of

production. Most MB in the world is

manufactured by only three companies,

two in the United States and one in

Israel. Whether their economies of

production can be maintained will

depend on the demand for MB for

exempted purposes in the United States

and other developed countries, and

overall demand in developing countries

(where final phaseout is scheduled

under the Montreal Protocol for 2015).

The demand for irradiation as a

treatment alternative will be influenced

by product quality and phytotoxicity

issues. Product shelf life can be

extended by irradiation. Moreover, some

fruits and vegetables that are damaged

by fumigation or temperature-modifying

treatments are tolerant of irradiation. On

the other hand, as indicated above for

grapes, some fruits and vegetables are

considered not very tolerant of

irradiation. Assuming consumers accept

irradiation as a phytosanitary treatment,

its use will be determined not only by

the availability of alternative treatments

and relative costs but also by its

enhancing or diminishing effects on

product quality.

When the latter range of unit costs

(3.4 to 3.9 cents per pound) are applied

to fumigated quantities of 11 varieties of

fruits imported in fiscal year 1996 that

have a high or medium tolerance of

irradiation, costs of irradiation

treatment range, in 1998 dollars,

between $2.7 million and $3.1 million.8

Applying MB fumigation costs assumed

in the 1994 study, 0.6 to 1.2 cents per

pound in 1998 dollars, yields a total

treatment cost of $0.5 million to $0.9

million for this same set of imports. It

is apparent that the use of irradiation for

phytosanitary purposes is probably not

a cost-competitive alternative to MB

fumigation at present. However, the

phaseout of MB as a soil fumigant may

result in an increase in its unit cost of

production, thereby making the cost of

irradiation and other treatment

alternatives more competitive.

Adopting this rule would broaden the

choices among phytosanitary treatment

alternatives for U.S. fruit and vegetable

importers. No net societal gains and

losses other than small price-related

changes are expected from this

proposed rule if irradiation is used only

to treat fruits and vegetables that would

have been imported otherwise using an

alternative treatment. Income earned by

firms providing the irradiation services

would be income forgone by the

displaced fumigators or other treatment

providers. But if irradiation enables

importations that would not otherwise

occur, then societal gains (increased

imports) could be attributed to its

phytosanitary use. Irradiation treatment

most likely will both serve as an

alternative treatment for a fraction of

current imports and stimulate

additional imports for certain fruits and

vegetables, such as papaya, that need to

be treated for fruit flies and have a high

tolerance for irradiation.

Allowing irradiation to be used as a

phytosanitary treatment for 11 fruit fly

species and one seed weevil species

would most immediately benefit four

firms, three of which are small entities,

that currently provide irradiation

services on contract for sterilization and

decontamination purposes.

Participation of these firms, and entry of

other firms, in the treatment of imported

fruits and vegetables will depend upon

the demand that develops for irradiation

in relation to alternative treatments.

The major alternative to this proposed

rule would be to not allow these

irradiation treatments. In that case,

importers and irradiation businesses

would not accrue the benefits described

above, and firms providing existing

treatment alternatives would continue

operating as at present (with MB

fumigation becoming less competitive as

its supply is constrained).

This proposed rule contains various

recordkeeping and reporting

requirements. These requirements are

described in this document under the

heading ‘‘Paperwork Reduction Act.’’

Executive Order 12988

This proposed rule has been reviewed

under Executive Order 12988, Civil

Justice Reform. If this proposed rule is

adopted: (1) All State and local laws and

regulations that are inconsistent with

this rule will be preempted; (2) no

retroactive effect will be given to this

rule; and (3) administrative proceedings

will not be required before parties may

file suit in court challenging this rule.

National Environmental Policy Act

An environmental assessment and

finding of no significant impact have

34122 Federal Register / Vol. 65, No. 103 / Friday, May 26, 2000 / Proposed Rules

been prepared for this proposed rule.

The assessment provides a basis for the

conclusion that the irradiation methods

proposed in this rule would not present

a risk of introducing or disseminating

plant pests and would not have a

significant impact on the quality of the

human 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

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 proposed

rule have been submitted for approval to

the Office of Management and Budget

(OMB). Please send written comments

to the Office of Information and

Regulatory Affairs, OMB, Attention:

Desk Officer for APHIS, Washington, DC

20503. Please state that your comments

refer to Docket No. 98–030–1. Please

send a copy of your comments to: (1)

Docket No. 98–030–1, Regulatory

Analysis and Development, PPD,

APHIS, suite 3C03, 4700 River Road

Unit 118, Riverdale, MD 20737–1238,

and (2) Clearance Officer, OCIO, USDA,

room 404–W, 14th Street and

Independence Avenue, SW.,

Washington, DC 20250. A comment to

OMB is best assured of having its full

effect if OMB receives it within 30 days

of publication of this proposed rule.

We are proposing to authorize

irradiation as a treatment for 11 species

of fruit flies and one species of seed

weevil in imported fruits and

vegetables. This proposal would

facilitate the importation of fruits and

vegetables by giving importers another

alternative to currently approved

treatments required for articles attacked

by these species of fruit flies and mango

seed weevils.

Implementing this rule would

necessitate the use of seven new

paperwork collection activities (in the

form of a compliance agreement, 24-

hour notification, labeling requirements,

dosimetry recordings, requests for

dosimetry device approval,

recordkeeping requirements, and

requests for facility approval).

Labeling requirements represent a

substantial part of the paperwork

burden. The proposed rule would

require that pallet loads of irradiated

fruits and vegetables be marked by

irradiation facility personnel or by the

shipper with treatment lot numbers,

packing and treatment facility

identification and locations, and dates

of packing and treatment. This

information would allow an inspector to

identify the treatment lots and trace

them back to the packing and treatment

facilities. The burden of this marking

requirement would increase for

importers who arrange to have pallet

loads broken apart into individual

cartons before entry into the United

States, because, in such cases,

individual cartons would have to bear

the required information to allow

successful traceback.

We are soliciting comments from the

public (as well as affected agencies)

concerning our proposed information

collection and recordkeeping

requirements. These comments will

help us:

(1) Evaluate whether the proposed

information collection is necessary for

the proper performance of our agency’s

functions, including whether the

information will have practical utility;

(2) Evaluate the accuracy of our

estimate of the burden of the proposed

information collection, including the

validity of the methodology and

assumptions used;

(3) Enhance the quality, utility, and

clarity of the information to be

collected; and

(4) Minimize the burden of the

information collection on those who are

to respond, such as through the use of

appropriate automated, electronic,

mechanical, or other technological

collection techniques or other forms of

information technology, e.g., permitting

electronic submission of responses.

Estimate of burden: Public reporting

burden for this collection of information

is estimated to average .0825 hours per

response.

Respondents: Irradiation facilities and

shippers.

Estimated annual number of

respondents: 125.

Estimated annual number of

responses per respondent: 999.

Estimated annual number of

responses: 124,885.

Estimated total annual burden on

respondents: 10,305.

Copies of this information collection

can be obtained from: Clearance Officer,

OCIO, USDA, Room 404–W, 14th Street

and Independence Avenue SW.,

Washington, DC 20250.

List of Subjects

7 CFR Part 305

Irradiation, Phytosanitary treatment,

Plant diseases and pests, Quarantine,

Reporting and recordkeeping

requirements.

7 CFR Part 319

Bees, Coffee, Cotton, Fruits, Honey,

Imports, Logs, Nursery Stock, Plant

diseases and pests, Quarantine,

Reporting and recordkeeping

requirements, Rice, Vegetables.

Accordingly, we propose to amend

title 7, chapter III, of the Code of Federal

Regulations as follows:

1. A new part 305 would be added to

read as follows:

PART 305—PHYTOSANITARY

TREATMENTS

Sec.

305.1 Definitions.

305.2 Irradiation treatment of imported

fruits and vegetables for certain fruit flies

and mango seed weevils.

Authority: 7 U.S.C. 150dd, 150ee, 150ff,

151–167, 450, 2803, and 2809; 21 U.S.C. 136

and 136a; 7 CFR 2.22, 2.80, and 371.2(c).

§ 305.1 Definitions.

The following definitions apply for

the purposes of this part:

Administrator. The Administrator,

Animal and Plant Health Inspection

Service, United States Department of

Agriculture, or any person delegated to

act for the Administrator in matters

affecting this part.

APHIS. The Animal and Plant Health

Inspection Service, United States

Department of Agriculture.

Dose mapping. Measurement of

absorbed-dose within a process load

using dosimeters placed at specified

locations to produce a one-, two-, or

three-dimensional distribution of

absorbed dose, thus rendering a map of

absorbed-dose values.

Dosimeter. A device that, when

irradiated, exhibits a quantifiable

Federal Register / Vol. 65, No. 103 / Friday, May 26, 2000 / Proposed Rules 34123

1The maximum absorbed ionizing radiation dose

and the irradiation of food is regulated by the Food

and Drug Administration under 21 CFR part 179.

2 Inspector means any employee of the Animal

and Plant Health Inspection Service, or other

person, authorized by the Administrator in

accordance with law to enforce the provisions of

the regulations of this part. Inspectors are assigned

to local offices of the Animal and Plant Health

Inspection Service, which are listed in telephone

directories.

change in some property of the device

that can be related to absorbed dose in

a given material using appropriate

analytical instrumentation and

techniques. Dosimetry system. A system used for

determining absorbed dose, consisting

of dosimeters, measurement instruments

and their associated reference standards,

and procedures for the system’s use.

§ 305.2 Irradiation treatment of imported

fruits and vegetables for certain fruit flies

and mango seed weevils.

(a) Approved doses. Irradiation at the

following doses for the specified fruit

flies and seed weevils, carried out in

accordance with the provisions of this

section, is approved as a treatment for

all fruits and vegetables:

IRRADIATION FOR FRUIT FLIES AND SEED WEEVILS IN IMPORTED FRUITS AND VEGETABLES

Scientific name Common name Dose (gray)

Bactrocera dorsalis ..................................................................... Oriental fruit fly ........................................................................... 250

Ceratitis capital ........................................................................... Mediterranean fruit fly ................................................................ 225

Bactrocera cucurbitae ................................................................. Melon fly ..................................................................................... 210

Anastrepha fraterculus ................................................................ South American fruit fly ............................................................. 150

Anastrepha suspensa ................................................................. Caribbean fruit fly ....................................................................... 150

Anastrepha ludens ...................................................................... Mexican fruit fly .......................................................................... 150

Anastrepha obliqua ..................................................................... West Indian fruit fly .................................................................... 150

Anastrepha serpentina ................................................................ Sapote fruit fly ............................................................................ 150

Bactrocera tryoni ......................................................................... Queensland fruit fly .................................................................... 150

Bactrocera jarvisi ........................................................................ (No common name) ................................................................... 150

Bactrocera latifrons ..................................................................... Malaysian fruit fly ....................................................................... 150

Cryptorhynchus mangiferae ........................................................ Mango seed weevil .................................................................... 100

(b) Location of facilities. Where

certified irradiation facilities are

available, an approved irradiation

treatment may be conducted for any

fruit or vegetable either prior to

shipment to the United States or in the

United States. Irradiation facilities

certified under this section may be

located 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, and Virginia. Prior to

treatment, the fruits and vegetables to be

irradiated may not move into or through

any of the States listed in this

paragraph, 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.

(c) Compliance agreement with

importers and facility operators for

irradiation in the United States. If

irradiation is conducted in the United

States, both the importer and the

operator of the irradiation facility must

sign compliance agreements with the

Administrator. In the facility

compliance agreement, the facility

operator must agree to comply with any

additional requirements found

necessary by the Administrator to

prevent the escape, prior to irradiation,

of any fruit flies that may be associated

with the articles to be irradiated. In the

importer compliance agreement, the

importer must agree to comply with any

additional requirements found

necessary by the Administrator to

ensure the shipment is not diverted to

a destination other than treatment and

to prevent escape of plant pests from the

articles to be irradiated during their

transit from the port of first arrival to

the irradiation facility in the United

States.

(d) Compliance agreement with

irradiation facilities outside the United

States. If irradiation is conducted

outside the United States, the operator

of the irradiation facility must sign a

compliance agreement with the

Administrator and the plant protection

service of the country in which the

facility is located. In this agreement, the

facility operator must agree to comply

with the requirements of this section,

and the plant protection service of the

country in which the facility is located

must agree to monitor that compliance

and to inform the Administrator of any

noncompliance. (e) Certified facility. The irradiation

treatment facility must be certified by

the Administrator. Recertification is

required in the event of an increase or

decrease in radioisotope, a major

modification to equipment that affects

the delivered dose, or a change in the

owner or managing entity of the facility.

Recertification also may be required in

cases where a significant variance in

dose delivery has been measured by the

dosimetry system. In order to be

certified, a facility must: (1) Be capable of administering the

minimum absorbed ionizing radiation

doses specified in paragraph (a) of this

section to the fruits and vegetables; 1

(2) 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.

(3) If the facility is located in the

United States, the facility will only be

certified if the Administrator determines

that regulated articles will be safely

transported to the facility from the port

of arrival without significant risk that

plant pests will escape in transit or

while the regulated articles are at the

facility.

(f) Treatment monitoring. Treatment

must be monitored by an inspector. This

monitoring must include inspection of

treatment records and unannounced

inspections of the facility by an

inspector. Facilities that carry out

continual irradiation operations must

notify an inspector at least 24 hours

before the date operations commence.2

Facilities that carry out periodic

irradiation operations must notify an

inspector of scheduled operations at

least 24 hours before scheduled

operations.

(g) Packaging. Fruits and vegetables

that are irradiated in accordance with

34124 Federal Register / Vol. 65, No. 103 / Friday, May 26, 2000 / Proposed Rules

3 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, Oxford Plant Protection Center,

901 Hillsboro Street, Oxford, NC 27565.

4 Designation E 1261–94, ‘‘Standard Guide for

Selection and Calibration of Dosimetry Systems for

Radiation Processing,’’ American Society for

Testing and Materials, Annual Book of ASTM

Standards.

this section must be packaged in cartons

in the following manner:

(1) All irradiated fruits and vegetables

must be shipped in the same cartons in

which they are irradiated. Irradiated

fruits and vegetables may not be

packaged for shipment in a carton with

nonirradiated fruits and vegetables.

(2) For all fruits and vegetables

irradiated prior to arrival in the United

States:

(i) The fruits and vegetables to be

irradiated must be packaged either:

(A) In insect-proof cartons that have

no openings that will allow the entry of

fruit flies. The cartons must be sealed

with seals that will visually indicate if

the cartons have been opened. The

cartons may be constructed of any

material that prevents the entry of fruit

flies and prevents oviposition by fruit

flies into the articles in the carton; 3 or

(B) In noninsect-proof cartons that are

stored immediately after irradiation in a

room completely enclosed by walls or

screening that completely precludes

access by fruit flies. If stored in

noninsect-proof cartons in a room that

precludes access by fruit flies, prior to

leaving the room each pallet of cartons

must be completely enclosed in

polyethylene, shrink-wrap, or another

solid or netting covering that completely

precludes access to the cartons by fruit

flies.

(ii) To preserve the identity of treated

lots, each pallet-load of cartons

containing the fruits and vegetables

must be wrapped before leaving the

irradiation facility in one of the

following ways:

(A) With polyethylene shrink 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. Pallets that remain intact as

one unit until entry into the United

States may have one such label per

pallet. Pallets that are broken apart into

smaller units prior to or during entry

into the United States must have the

required label information on each

individual carton.

(h) Dosimetry systems at the

irradiation facility. (1) Dosimetry

mapping must indicate the doses

needed to ensure that all the commodity

will receive the minimum dose

prescribed.

(2) Absorbed dose must be measured

using an accurate dosimetry system that

ensures that the absorbed dose meets or

exceeds the absorbed dose required by

paragraph (a) of this section (150, 210,

225, or 250 Gray, depending on the

target species of fruit fly).

(3) The utilization of the dosimetry

system, including the number and

placement of dosimeters used, must be

in accordance with American Society

for Testing and Materials (ASTM)

standards.4

(i) Records. An irradiation processor

must maintain records of each treated

lot for 1 year following the treatment

date and must make these records

available for inspection by an inspector

during normal business hours (8 a.m. to

4:30 p.m., Monday through Friday,

except holidays). 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.

(j) Request for certification and

inspection of facility. Persons requesting

certification of an irradiation treatment

facility 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 Street,

Oxford, NC 27565. The initial request

must identify the owner, location, and

radiation source of the facility, and the

applicant must supply additional

information about the facility

construction, treatment protocols, and

operations upon request by APHIS if

APHIS requires additional information

to evaluate the request. Before the

Administrator determines whether an

irradiation facility is eligible for

certification, an inspector will make a

personal inspection of the facility to

determine whether it complies with the

standards of this section.

(k) Denial and withdrawal of

certification. (1) The Administrator will

withdraw the certification of any

irradiation treatment facility upon

written request from the irradiation

processor.

(2) The Administrator will deny or

withdraw certification of an irradiation

treatment facility when any provision of

this section is not met. Before

withdrawing or denying certification,

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 certification pending final

determination in the proceeding if he or

she determines that suspension is

necessary to prevent the spread of any

dangerous insect. 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.

(l) Department not responsible for

damage. This treatment is approved to

assure quarantine security against the

listed fruit flies. 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 monitored.

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.

PART 319—FOREIGN QUARANTINE

NOTICES

2. The authority citation for part 319

would continue to read as follows:

Authority: 7 U.S.C. 150dd, 150ee, 150ff,

151–167, 450, 2803, and 2809; 21 U.S.C. 136

and 136a; 7 CFR 2.22, 2.80, and 371.2(c).

3. In § 319.56–2, a new paragraph (k)

would be added to read as follows:

§ 319.56–2 Restrictions on entry of fruits

and vegetables.

* * * * *

(k) Any fruit or vegetable that is

required by this subpart or the Plant

Protection and Quarantine Treatment

Manual to be treated or subjected to

other growing or inspection

requirements to control one or more of

the 11 species of fruit flies and one

Federal Register / Vol. 65, No. 103 / Friday, May 26, 2000 / Proposed Rules 34125

species of seed weevil listed in

§ 305.2(a) of this chapter as a condition

of entry into the United States may

instead be treated by irradiation in

accordance with part 305 of this

chapter.

4. In § 319.56–2x, paragraph (a), the

introductory text preceding the table

would be revised to read as follows:

§ 319.56–2x Administrative instructions;

conditions governing the entry of certain

fruits and vegetables for which treatment is

required.

(a) The following fruits and vegetables

may be imported into the United States

only if they have been treated in

accordance with the Plant Protection

and Quarantine (PPQ) Treatment

Manual, which is incorporated by

reference at § 300.1 of this chapter.

Treatment by irradiation in accordance

with part 305 of this chapter may be

substituted for treatments in the PPQ

Treatment Manual for the mango seed

weevil Cryptorhynchus mangiferae or

for one or more of the following 11

species of fruit flies: Anastrepha ludens,

Anastrepha obliqua, Anastrepha

serpentina, Anastrepha suspensa,

Bactrocera cucurbitae, Bactrocera

dorsalis, Bactrocera tryoni, Bactrocera

jarvisi, Bactrocera latifrons, and

Ceratitis capitata.

* * * * *

Done in Washington, DC, this 23rd day of

May 2000.

Craig A. Reed,

Administrator, Animal and Plant Health

Inspection Service.

[FR Doc. 00–13291 Filed 5–25–00; 8:45 am]

BILLING CODE 3410–34–U

DEPARTMENT OF AGRICULTURE

Rural Utilities Service

7 CFR Part 1792

RIN 0572–AB47

Seismic Safety

AGENCY: Rural Utilities Service, USDA.

ACTION: Proposed rule.

SUMMARY: The Rural Utilities Service

(RUS) proposes to amend its regulations

to update and simplify the requirements

of the agency. This revised rule would

provide RUS borrowers, grant

recipients, Rural Telephone Bank (RTB)

borrowers and the public with updated

rules for compliance with seismic safety

requirements for new building

construction using RUS or RTB loan,

grant or guaranteed funds or funds

provided through lien accommodations

or subordinations approved by RUS or

RTB. The proposed revision would

identify model codes and standards

found to provide a required level of

seismic safety.

DATES: Written comments must be

received by RUS on or before July 25,

2000.

ADDRESSES: Written comments should

be addressed to George J. Bagnall,

Director, Electric Staff Division, U.S.

Department of Agriculture, Rural

Utilities Service, Room 1246 South

Building, Stop 1569, 14th &

Independence Ave., SW., Washington,

DC 20250–1569. Telephone 202–720–

1900. RUS requests a signed original

and three copies of all comments (7 CFR

1700.4). Comments will be available for

public inspection during regular

business hours (7 CFR 1.27(b)).

FOR FURTHER INFORMATION CONTACT: Mr.

Donald Heald, Structural Engineer,

Transmission Branch, Electric Staff

Division, Rural Utilities Service, U.S.

Department of Agriculture, 1400

Independence Avenue, SW, STOP 1569,

Washington, DC 20250–1569.

Telephone: (202) 720–9102. Fax: (202)

720–7491.

SUPPLEMENTARY INFORMATION:

Executive Order 12866

This proposed 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

(OMB).

Executive Order 12372

This proposed rule is excluded from

the scope of Executive Order 12372,

Intergovernmental Consultation, which

may require consultation with State and

local offices. See the final rule related

notice entitled ‘‘Department Programs

and Activities Excluded from Executive

Order 12372’’ (50 FR 47034).

Executive Order 12988

This proposed rule has been reviewed

in accordance with Executive Order

12988, Civil Justice Reform. RUS has

determined that this proposed rule

meets the applicable standards provided

in section 3 of the Executive Order. In

addition, all State and local laws and

regulations that are in conflict with this

rule will be preempted; no retroactive

effect will be given to this rule; and, in

accordance with section 212(e) of the

Department of Agriculture

Reorganization Act of 1994 (7 U.S.C.

6912(e)) administrative appeal

procedures, if any are required, must be

exhausted prior to initiating litigation

against the Department or its agencies.

Regulatory Flexibility Act Certification

The Administrator of RUS has

determined that this rule will not have

significant economic impact on a

substantial number of small entities as

defined in the Regulatory Flexibility Act

(5 U.S.C. 601 et seq.). The RUS and RTB

loan programs provide borrowers with

loans at interest rates and terms that are

more favorable than those generally

available from the private sector.

Borrowers, as a result of obtaining

federal financing, receive economic

benefits that exceed any direct cost

associated with RUS regulations and

requirements.

Information Collection and

Recordkeeping Requirements

In accordance with the Paperwork

Reduction Act of 1995 (44 U.S.C.

chapter 35), RUS invites comments on

this information collection for which

RUS intends to request approval from

the Office of Management and Budget

(OMB).

Comments on this notice must be

received by July 25, 2000.

Comments are invited on (a) whether

the collection of information is

necessary for the proper performance of

the functions of the agency, including

whether the information will have

practical utility; (b) the accuracy of the

agency’s estimate of burden including

the validity of the methodology and

assumption used; (c) ways to enhance

the quality, utility and clarity of the

information to be collected; and (d)

ways to minimize the burden of the

collection of information on those who

are to respond, including through the

use of appropriate automated,

electronic, mechanical, or other

technological collection techniques on

other forms of information technology.

Comments may be sent to F. Lamont

Heppe, Jr., Director, Program

Development and Regulatory Analysis,

Rural Utilities Service, U.S. Department

of Agriculture, 1400 Independence Ave.,

SW., Stop 1522, Room 4034 South

Building, Washington, D.C. 20250–1522.

For further information contact Mr.

Donald Heald, Structural Engineer,

Transmission Branch, Electric Staff

Division, Rural Utilities Service, U.S.

Department of Agriculture, 1400

Independence Avenue, SW, STOP 1569,

Washington, DC 20250–1569.

Telephone: (202) 720–9102. Fax: (202)

720–7491.

Title: Seismic Safety of New Building

Construction.

OMB Control Number: 0572–0099.

Type of Request: Revision of a

currently approved collection.

Abstract: The Earthquake Hazards

Reduction Act of 1977 (42 U.S.C. 7701