[Federal Register Volume 65, Number 103 (Friday, May 26, 2000)]
[Proposed Rules]
[Pages 34113-34125]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-13291]


 ========================================================================
 Proposed Rules
                                                 Federal Register
 ________________________________________________________________________
 
 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.
 
 ========================================================================
 

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

[[Page 34113]]



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

[[Page 34114]]

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:
---------------------------------------------------------------------------

    \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.

     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                150
                                  fly.
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 research\2\ to recommend 
irradiation doses for 11 species of tephritid fruit flies and one 
species of seed weevil.
---------------------------------------------------------------------------

    \2\ Reports 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.
---------------------------------------------------------------------------

    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

[[Page 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 post-treatment 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) deg.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

[[Page 34116]]

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 cross-references 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 Sec. 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 Sec. 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 Sec. 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 Sec. 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.

[[Page 34117]]

    Proposed Sec. 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 Sec. 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 Sec. 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 Sec. 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

[[Page 34118]]

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 Sec. 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 Sec. 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 Sec. 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 Sec. 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.
---------------------------------------------------------------------------

    \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.

 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.

[[Page 34119]]

 
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 Sec. 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 Secs. 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 
Sec. 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 Sec. 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, Sec. 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 
Sec. 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 
Sec. 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, Sec. 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 Sec. 319.56-2k; if fruit flies are the only pest in 
that country requiring precooling and fumigation under Sec. 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 Sec. 319.56-2dd. To prevent the 
introduction of Mediterranean fruit fly, Sec. 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 Sec. 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.

[[Page 34120]]

    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 cost-benefit 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

[[Page 34121]]

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 temperature-modifying treatments are possible alternatives for 
some fruits and vegetables, MB fumigation is the principal, and 
sometimes sole, phytosanitary treatment available for many commodities.
---------------------------------------------------------------------------

    \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.
    \5\ ``Quarantine Uses of Methyl Bromide by the United States, 
Fiscal Year 1996'' (Draft), APHIS-PPD-PAD, April 1997; available in 
the APHIS reading room (see ADDRESSES).
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \6\ To 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).
---------------------------------------------------------------------------

    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).
---------------------------------------------------------------------------

    \7\ Ten 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).
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \8\ The 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.
---------------------------------------------------------------------------

    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

[[Page 34122]]

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).


Sec. 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

[[Page 34123]]

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.


Sec. 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                150
                                  fly.
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\
---------------------------------------------------------------------------

    \1\ The maximum absorbed ionizing radiation dose and the 
irradiation of food is regulated by the Food and Drug Administration 
under 21 CFR part 179.
---------------------------------------------------------------------------

    (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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    (g) Packaging. Fruits and vegetables that are irradiated in 
accordance with

[[Page 34124]]

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

    \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.
---------------------------------------------------------------------------

    (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\
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    (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 Sec. 319.56-2, a new paragraph (k) would be added to read as 
follows:


Sec. 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

[[Page 34125]]

species of seed weevil listed in Sec. 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 Sec. 319.56-2x, paragraph (a), the introductory text 
preceding the table would be revised to read as follows:


Sec. 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 Sec. 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