[Federal Register Volume 62, Number 132 (Thursday, July 10, 1997)]
[Rules and Regulations]
[Pages 36967-36976]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-17672]



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  Federal Register / Vol. 62, No. 132 / Thursday, July 10, 1997 / Rules 
and Regulations  

[[Page 36967]]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

7 CFR Parts 300 and 318

[Docket No. 95-069-2]


Papaya, Carambola, and Litchi From Hawaii

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Final rule.

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SUMMARY: We are increasing the irradiation treatment dose required for 
papayas intended for interstate movement from Hawaii and allowing 
carambolas to be moved interstate from Hawaii with irradiation 
treatment. We are also allowing litchis to be moved interstate from 
Hawaii if they are inspected and found free of the litchi fruit moth 
and other plant pests and undergo irradiation or hot water treatment 
for fruit flies. We are allowing papayas, carambolas, and litchis from 
Hawaii to undergo irradiation treatment either in Hawaii or in non-
fruit fly supporting areas of the mainland United States. In addition, 
we are making several amendments to the requirements for irradiation 
procedures and facilities and the handling of treated and untreated 
fruits and vegetables. Finally, we are amending the definition for 
inspector to include State plant regulatory officials designated by the 
Administrator of the Animal and Plant Health Inspection Service, U.S. 
Department of Agriculture. These actions will facilitate the interstate 
movement of papayas, carambolas, and litchis from Hawaii while 
continuing to provide protection against the spread of injurious plant 
pests from Hawaii to other parts of the United States.

EFFECTIVE DATE: July 10, 1997. The incorporation by reference of 
certain publications listed in the regulations is approved by the 
Director of the Federal Register as of July 10, 1997.

FOR FURTHER INFORMATION CONTACT: Mr. Peter M. Grosser, Senior Staff 
Officer, Port Operations, PPQ, APHIS, 4700 River Road Unit 139, 
Riverdale, MD 20737-1236, (301) 734-6799.

SUPPLEMENTARY INFORMATION:

Background

    The Hawaiian Fruits and Vegetables regulations, contained in 7 CFR 
318.13 through 318.13-17 (referred to below as the regulations), 
govern, among other things, the interstate movement of fruits and 
vegetables, including papayas, from Hawaii. Regulation is necessary to 
prevent the spread of the Mediterranean fruit fly (Ceratitis capitata), 
the melon fly (Bactrocera cucurbitae), and the Oriental fruit fly 
(Bactrocera dorsalis), which occur in Hawaii. These types of fruit 
flies are collectively referred to in this document as Trifly.
    The regulations allow papayas to be moved interstate from Hawaii to 
any destination in the United States if, among other things, they have 
been treated for Trifly. One approved treatment for Trifly in papayas 
is irradiation. Prior to the effective date of this final rule, 
Sec. 318.13-4f provided for irradiation of papayas, but no other 
fruits, at an approved facility in Hawaii at an irradiation dose of 150 
Gray (15 krad).
    On July 23, 1996, we published in the Federal Register (61 FR 
38108-38114, Docket No. 95-069-1) a proposal to amend the regulations 
by increasing the irradiation treatment dose required for papayas 
intended for interstate movement from Hawaii; allowing carambolas to be 
moved interstate from Hawaii with irradiation treatment; allowing 
litchis to be moved interstate from Hawaii if they are inspected and 
found free of the litchi fruit moth and undergo irradiation or hot 
water treatment for fruit flies; allowing papayas, carambolas, and 
litchis from Hawaii to undergo irradiation treatment either in Hawaii 
or in non-fruit fly supporting areas of the mainland United States; 
making several amendments to the requirements for irradiation 
procedures and facilities and the handling of treated and untreated 
fruits and vegetables; and amending the definition of inspector to 
include State plant regulatory officials designated by the 
Administrator of the Animal and Plant Health Inspection Service 
(APHIS), U.S. Department of Agriculture.
    We solicited comments concerning our proposal for 30 days ending 
August 22, 1996. We received 45 comments by that date. They were from 
growers, producers, university personnel, and representatives of 
industry, irradiation associations, and State governments. One 
commenter supported the proposed rule in its entirety. The remaining 44 
commenters had concerns about portions of the proposed rule. Their 
concerns are discussed below.
    Comment: APHIS should not allow Trifly host fruit from Hawaii to be 
shipped to the mainland United States for treatment. Treatments should 
be conducted before the fruit leaves Hawaii. Arrival of untreated 
Trifly host material on the mainland United States, even in non-fruit 
fly supporting areas, would present too great a risk of Trifly being 
introduced into susceptible States. Factors contributing to this risk 
include misrouting, diversion of shipments, and repackaging and 
redistribution prior to treatment; the possibility of planes carrying 
untreated fruit crashing in susceptible States; and the possible 
establishment of Trifly in northern States during the summer months, 
with subsequent movement of infected host material into susceptible 
States.
    Response: With the careful growing practices of Hawaii's commercial 
growers, such as administering pre-harvest chemical controls and 
keeping production fields clear of fallen fruit during harvest, we 
believe that occurrence of Trifly in cartons of untreated fruit from 
Hawaii will be rare. We believe that the packaging and movement 
provisions established by this rule for shipments of papaya, carambola, 
and litchi moving interstate to the mainland United States from Hawaii 
for treatment will further protect the mainland United States from the 
introduction of Trifly.
    Specifically, untreated carambola, litchi, and papaya moving 
interstate to the mainland United States for treatment may not be moved 
with treated fruits or vegetables. This will prevent treated 
commodities from becoming infested with Trifly, and help ensure that 
untreated fruit is not inadvertently distributed in the United States 
with treated fruit. Although our rule allows untreated fruit bound for

[[Page 36968]]

treatment on the mainland United States to be packaged in either non-
vented or vented cartons, any Trifly that might be present in the 
shipment would most likely be eggs and larvae, and it is unlikely that 
eggs and larvae would escape from normal vented packaging.
    In addition, in the unlikely event that a shipment of untreated 
papaya, carambola, or litchi from Hawaii contains an injurious plant 
pest that escapes from a carton after arriving on the mainland United 
States, the areas into which shipments of untreated fruit from Hawaii 
may move are limited to those where Trifly would not be able to sustain 
a reproducing population. Irradiation treatment on the mainland United 
States may not be conducted in Alabama, Arizona, California, Florida, 
Georgia, Kentucky, Louisiana, Mississippi, Nevada, New Mexico, North 
Carolina, South Carolina, Tennessee, Texas, or Virginia. Prior to 
treatment, the papaya, carambola, and litchi may not move into or 
through Alabama, Arizona, California, Florida, Georgia, Kentucky, 
Louisiana, Mississippi, Nevada, New Mexico, North Carolina, South 
Carolina, Tennessee, Texas, or Virginia, except that Dallas/Fort Worth, 
Texas, is an authorized stop for air cargo and a transloading location 
for shipments that arrive by air but that are subsequently transloaded 
into trucks for overland movement from Dallas/Fort Worth into an 
authorized State by the shortest route. In addition, both treated and 
untreated litchi from Hawaii may not be moved into or distributed in 
the State of Florida.
    Apart from restricting the movement into Florida of litchi from 
Hawaii, we are establishing these movement restrictions because cooler 
climates will not support the establishment of successive generations 
of fruit flies. All three species of fruit fly identified in this 
document are distributed around the world but only establish 
reproducing populations in tropical, subtropical, and Mediterranean 
climates. For example, these species of fruit fly have had ample 
opportunity to establish reproducing populations in more northern 
countries such as Canada, Germany, and The Netherlands, where untreated 
host material has been imported from countries with climates suitable 
for fruit fly establishment for many years; however, the cold climates 
of these three northern countries have prevented the establishment of 
successive populations of fruit flies. We are confident that these 
three species of fruit fly do not have a life stage that can survive 
the cold winters of our northern tier States. Additionally, we have 
been cold treating fruit fly host material from foreign countries in 
the northern United States for many years, and we have not recorded an 
established population of fruit flies in any northern State, during 
either the summer months or at any other time during the year, as a 
result of these imports. Therefore, we do not believe that the 
interstate movement of Hawaiian fruit for treatment on the mainland 
United States presents a risk of establishing Trifly in States into 
which Hawaiian fruit may move prior to treatment during the summer 
months or at other times during the year, and we, therefore, do not 
expect infested host material to move from northern States into more 
susceptible southern States prior to treatment for fruit flies.
    Also, papaya, carambola, and litchi moved from Hawaii to the 
mainland United States for treatment must be treated prior to 
distribution on the mainland United States. The irradiation treatment 
for fruit flies, as well as the other treatments outlined in our 
proposal, meets probit 9 quarantine security. Probit 9 security means 
that no more than 32 per 1,000,000 treated individuals (such as fruit 
flies) will pass through treatment and still emerge as adults. Since it 
is extremely unlikely that a consignment of fruit from Hawaii could be 
infested at such a high rate, a probit 9 level treatment assures that 
essentially all target pests will be effectively treated so as to 
prevent their adult emergence. Probit 9 is a longstanding APHIS policy. 
We believe that probit 9 treatment procedures are sufficient to prevent 
the introduction and establishment of plant pests on the mainland 
United States.
    We acknowledge that there is always the risk of misrouting, 
diversion of shipments, or a plane crash, but this risk is negligible. 
Further, in order to prevent the accidental misrouting or deliberate 
diversion of shipments of untreated fruit from Hawaii bound for 
treatment facilities on the mainland United States, each shipment of 
fruit from Hawaii requiring treatment on the mainland United States 
must move under limited permit. The limited permit will be issued by 
inspectors in Hawaii, who will notify APHIS personnel on the mainland 
United States of the issuance of the limited permit. The shipment of 
untreated fruit will then move interstate to a port staffed by APHIS 
personnel on the mainland United States. Therefore, at all points 
during the interstate movement, authorized personnel will be on hand to 
help prevent accidental misrouting, deliberate diversion, or 
repackaging and redistribution of untreated Hawaiian fruit.
    Therefore, we are making no changes to the proposed rule in 
response to this comment.
    Comment: In the absence of an irradiation facility in Hawaii, APHIS 
should require other treatments, such as cold or heat treatments, 
before fruit from Hawaii is moved interstate to the mainland United 
States.
    Response: We feel that such cold or heat treatments of papaya, 
carambola, and litchi from Hawaii are not necessary because, combined 
with the packaging and movement requirements proposed for fruit from 
Hawaii, the proposed irradiation treatment for papaya, carambola, and 
litchi from Hawaii is sufficient to mitigate the risk of the 
introduction and establishment of Trifly and other injurious plant 
pests on the mainland United States. Additionally, for some time, we 
have permitted the untreated fruit fly host material of a number of 
foreign countries to undergo treatment on the mainland United States. 
We do not believe that there is cause to ask more of Hawaii than we do 
of those foreign countries. Therefore, we are making no changes to the 
proposed rule in response to this comment.
    Comment: APHIS should require litchis from Hawaii to be cold 
treated prior to arrival on the mainland United States. Cold treatment 
is now required for litchis imported from foreign countries, such as 
Taiwan.
    Response: We require cold treatment for litchis imported from 
Taiwan because of Oriental fruit fly (Bactrocera dorsalis) and litchi 
fruit borer (Conopomorpha sinensis). Though litchi from Hawaii also 
must be treated for Oriental fruit fly, as well as other pests, we do 
not believe that cold treatment is necessary for Hawaiian litchi. The 
hot water and irradiation treatments for litchi provided by this rule, 
combined with the movement restrictions discussed previously and the 
required inspection for litchi fruit moth and other plant pests, are 
sufficient to prevent the introduction of Trifly, litchi rust mite, and 
other injurious plant pests into the United States. In the future, we 
will consider any request to allow the cold treatment of Hawaiian 
litchi as an alternative to irradiation or hot water treatment. At this 
time, however, we are making no changes to the proposed rule in 
response to this comment.
    Comment: APHIS should prohibit litchis from moving into either 
Florida or California unless the risk of introducing litchi rust mite, 
litchi fruit moth, Koa seedworm (also known as Macadamia nut borer), 
and light brown apple moth can be addressed. Regulations and stamps 
prohibiting the

[[Page 36969]]

movement of litchis into Florida will not keep infested fruit out of 
Florida.
    Response: Because of Florida's commercial production of litchi, 
litchi from Hawaii will not be allowed to move into or be distributed 
in Florida, and cartons of litchi from Hawaii will be stamped with that 
information so that they are not inadvertently shipped to Florida.
    Though we do not currently have sufficient data to judge the effect 
on litchi rust mite (Eriophyes litchi) of the irradiation dose adopted 
in this final rule for Trifly (250 Gray), we do expect, based on the 
available information, some deleterious effect on any litchi rust mites 
in a shipment of litchi that undergoes an irradiation treatment 
according to the provisions outlined in the proposal. Yet APHIS is not 
relying upon irradiation treatment as the primary means of reducing the 
risk associated with the litchi rust mite. We have determined that 
there is little chance that a litchi rust mite will stay on a litchi 
fruit throughout the growth, harvest, and packing of the litchi fruit. 
Litchi rust mite is most closely associated with the leaves and other 
plant parts of the litchi. Because we are only allowing the fruit of 
the litchi to be moved interstate from Hawaii, we believe that there is 
only a remote chance that litchi rust mite will be associated with 
fruit that is packed in a shipment of litchi moving interstate from 
Hawaii. We believe that the inspection, movement, and treatment 
provisions established for litchi by this rule will prevent litchi rust 
mite from being introduced into the mainland United States. However, as 
an added precaution to ensure protection of Florida's litchi industry, 
APHIS is prohibiting movement of Hawaiian litchi into Florida.
    Further, we believe that litchi moved interstate from Hawaii under 
this rule will present a negligible risk of introducing litchi fruit 
moth (Cryptophlebia ombrodelta), Koa seedworm (Cryptophlebia illepida 
[Butler]), or light brown apple moth (Epiphyas postvittana) anywhere on 
the mainland United States.
    The cultural practices employed by Hawaiian tree fruit growers, 
such as administering pre-harvest chemical controls, keeping production 
fields clear of fallen fruit during harvest, and keeping field borders 
clear of hale koa (favored host of Cryptophlebia spp.), greatly reduce 
the possibility that litchi fruit moth, Koa seedworm, or light brown 
apple moth will be associated with Hawaiian litchi moving to the 
mainland United States. However, we are not depending on those growing 
practices alone to mitigate the risk of the introduction of these pests 
on the mainland United States. Our rule also requires litchi from 
Hawaii to be inspected and found free of litchi fruit moth and other 
pests (including Koa seedworm and light brown apple moth) prior to 
treatment in Hawaii or prior to interstate movement if the litchi will 
be treated on the mainland United States. Each of these pests is 
readily detectable by inspection. We believe that the control and 
suppression measures used by Hawaiian commercial growers and the 
inspection of the litchi will mitigate the risk of the introduction of 
these pests onto the mainland United States.
    In the preamble of our proposal, we stated that each shipment of 
litchi, whether treated in Hawaii or moving to the mainland United 
States for treatment, would be inspected in Hawaii prior to treatment 
or interstate movement for litchi fruit moth and other pests of 
concern. However, in the rule portion of our proposal, we did not make 
the inspection provisions clear for litchi undergoing irradiation 
treatment. Therefore, we have revised Sec. 318.13-4f(b)(7)(i) and (ii) 
to clarify that all litchi from Hawaii must be inspected in Hawaii and 
found free of litchi fruit moth and other pests of concern prior to 
treatment or interstate movement.
    Comment: APHIS should require untreated fruit, as well as treated 
fruit, to be packaged in a pest-proof carton, and the carton to be 
sealed before the fruit is to be moved from Hawaii. This would provide 
additional quarantine security.
    Response: We proposed that all treated carambola, litchi, and 
papaya be packaged in pest-proof cartons to protect the fruit from re-
infestation by Trifly. We proposed to allow untreated carambola, 
litchi, and papaya moving interstate to the mainland United States to 
move in either non-vented or in vented cartons. We proposed this 
flexibility for the packaging of untreated fruit because prevention of 
reinfestation is not an issue and because, as explained earlier in this 
document, any Trifly that might be present in the shipment would most 
likely be eggs and larvae, and it is unlikely that eggs and larvae 
could escape from normal vented packaging. Additionally, if Trifly eggs 
and larvae were present in the shipment, and if they reached maturity 
and escaped, it is unlikely that they could establish a reproducing 
population in the areas in which movement of untreated fruit will be 
authorized under the regulations because of either the relatively cool 
climate or the lack of suitable commercial host material in those 
areas. Untreated carambola, litchi, and papaya must be treated before 
being distributed outside these areas.
    We agree with the commenter that seals are a good way to help 
ensure the proper handling of shipments. Under our proposal, each 
carton of fruit treated in Hawaii that moves interstate to the mainland 
United States would be required to be sealed with seals that visually 
indicate if the cartons have been opened. However, we did not propose 
to require seals for cartons of untreated fruit. In response to this 
comment, we are requiring seals for shipping containers of untreated 
fruit moving interstate from Hawaii, as well as cartons of fruit 
treated in Hawaii. Because cartons of untreated Hawaiian fruit will be 
placed in sealed shipping containers prior to interstate movement to 
the mainland United States, we have determined that it is not necessary 
to seal each carton of untreated fruit. This provision would help 
ensure that no cartons within the sealed shipping container have been 
tampered with or removed. Therefore, we are amending Sec. 301.13-
4f(b)(4)(i) to require that shipping containers of untreated papaya, 
litchi, and carambola from Hawaii be sealed prior to interstate 
movement with seals that will visually indicate if the shipping 
containers have been opened.
    Comment: The requirement that each carton of treated fruit be 
stamped ``Treated--USDA, APHIS'' should be retained to ensure product 
differentiation at the treatment facility and in the distribution 
channels afterward.
    Response: In order to ensure that no cartons are added to or 
removed from a pallet load of cartons of Hawaiian fruit moving to the 
mainland United States, we proposed that pallet loads be wrapped in one 
of the following ways: With polyethylene sheet wrap, with net wrapping, 
or with strapping so that each carton on an outside row of the pallet 
load is constrained by a metal or plastic strap. We further proposed to 
require that pallet loads of treated carambola, litchi, and papaya be 
marked with treatment lot numbers, packing and treatment facility 
identification and locations, and dates of packing and treatment so 
that an inspector could identify the treatment lots of shipments and 
trace shipments back to the facilities where they were packed and 
treated. We proposed this method of labeling to replace the requirement 
that individual cartons be marked with a ``Treated'USDA, APHIS'' stamp. 
We believe that our proposed method will offer more information than 
our current method about a shipment or shipments

[[Page 36970]]

of fruit from Hawaii if an infestation is detected on the mainland 
United States. Therefore, we are making no changes to the proposed rule 
in response to this comment.
    Comment: Only fruit treated in Hawaii should be required to be 
packaged in pest-proof cartons.
    Response: We agree. Under our proposal, only carambola, litchi, and 
papaya from Hawaii that are treated in Hawaii will have to move in 
pest-proof cartons, in accordance with Sec. 318.13-4f(b)(4)(i)(A). 
Carambola, litchi, and papaya from Hawaii that are treated on the 
mainland United States, and carambola, litchi, and papaya moving to the 
mainland United States for treatment, will not have to move in pest-
proof cartons. Carambola, litchi, and papaya from Hawaii that are 
treated on the mainland United States will not be subject to further 
possible invasion by pests of concern after treatment, so we do not 
believe that cartons carrying these treated fruits need to be pest-
proof. Fruit moving to the mainland United States for treatment also 
does not need to be shipped in pest-proof cartons for reasons explained 
earlier in this document. Therefore, we are making no changes to the 
proposed rule in response to this comment.
    Comment: If fruit is allowed to move to the mainland United States 
from Hawaii for treatment, the production areas in Hawaii should be 
required to undergo malathion bait spray treatments, beginning 30 days 
before harvest begins and continuing until harvest ends.
    Response: Treating production areas with bait spray, consisting of 
95 percent malathion ULV mixed with a protein hydrolyzate applied at 
the rate of 2.4 ounces of malathion mixed with 9.6 ounces of protein 
hydrolyzate per acre, applied at 7 to 10 day intervals, with treatments 
commencing 30 days prior to harvest and continuing until harvest is 
complete, was a common practice in APHIS' eradication of the 
Mediterranean fruit fly (Medfly) in California in the 1980s. Bait spray 
treatments would be effective in suppressing the fruit fly population 
in production areas of Hawaii; however, it does not seem necessary to 
require bait spray treatments in addition to the treatment and other 
procedures required by this rule, because we believe these procedures 
provide security against the introduction and establishment of fruit 
flies and other pests on the mainland United States. Therefore, we are 
making no changes to the proposal in response to this comment.
    Comment: It is important that an inspector be physically present at 
the time of treatment either in Hawaii or on the mainland United 
States; therefore, the description of irradiation treatment procedures 
should include the phrase ``under the supervision of an inspector.''
    Response: Regarding the phrase ``under the supervision of an 
inspector'' in relation to irradiation treatment, each and every 
irradiation treatment conducted on the mainland United States is not 
required to be directly supervised by an APHIS inspector. Instead, it 
is our intent to certify the irradiation facility and its operators 
initially and renew that certification every year. This certification, 
coupled with the placement of dosimeters, in accordance with ASTM 
standards, helps to ensure that the irradiation treatment process is 
completed carefully and accurately. Therefore, we are making no changes 
to the proposed rule in response to this comment.
    Comment: If there are no dose indicators on a shipment, what will 
you do to be sure records will allow traceback?
    Response: This rule requires a treatment facility to have 
dosimeters to accurately measure the absorbed irradiation dose for each 
lot of fruit treated at the facility. After the treatment is conducted, 
the shipment must be marked with its treatment lot number, packing and 
treatment facility identification and location, and date of packing and 
treatment so that an inspector can identify the treatment lot of the 
shipment and trace the shipment back to the facility where it was 
packed and treated. At the irradiation facility where the treatment 
took place, the records of irradiation treatment and the measurements 
of the dosimeters must be available for APHIS review and verification.
    Comment: What is your rationale for increasing the irradiation dose 
from 150 Grays to 250 Grays?
    Response: USDA scientists have done exhaustive reviews of the 
published research related to irradiation treatments for fruit flies. 
These scientists also have conducted research to prove the efficacy of 
quarantine treatments, including irradiation treatments. APHIS' 
adoption of 250 Gray as the minimum dose for the fruit flies of concern 
from Hawaii is based on the recommendation of these scientists after 
considering the level of quarantine security required by APHIS, the 
species of flies to be treated, and the level of confidence provided by 
current information.
    Quarantine security involves defining two primary variables, the 
required endpoint and the level of efficacy. The endpoint for most 
quarantine treatments is mortality. However, an advantage associated 
with irradiation is the opportunity to select from a range of endpoints 
including mortality, the inability to mature, and the inability for 
pests to reproduce (sterility). The endpoint adopted by APHIS for fruit 
flies is ``preventing adult emergence.'' Mortality is deemed to be an 
excessive requirement that would result in significantly higher doses 
that are also more likely to cause damage to the commodity. Sterility 
as an endpoint provides quarantine security and is likely to require a 
lower dose, but it causes regulatory problems because the milder dose 
allows live flies to emerge from fruit. If detected, these flies could 
trigger regulatory actions because there is not currently a practical 
means to distinguish sterile flies from fertile flies. Therefore, the 
appropriate endpoint has been determined by APHIS to be ``preventing 
adult emergence.''
    The level of efficacy required by APHIS is probit 9. As discussed 
above, a probit 9 level treatment assures that essentially all target 
pests will be effectively sterilized or destroyed.
    The target pests for the treatment of Hawaiian fruit are the Trifly 
group, including the Oriental fruit fly, the Medfly, and the melon fly. 
The dose of 250 Gray has been determined by APHIS to be necessary to 
achieve quarantine security for the Oriental fruit fly. A dose of 225 
Gray has been adopted by APHIS for Medfly, and a dose of 210 Gray has 
been adopted by APHIS for the treatment of melon fly (see a notice 
published in the Federal Register on Wednesday, May 15, 1996, 61 FR 
24433-24439, Docket No. 95-088-1). Since any of the three species may 
be present in fruit for treatment from Hawaii, APHIS is requiring the 
dose for the most resistant species, the Oriental fruit fly.
    A dose of 150 Gray has been widely recommended as a generic dose 
for all fruit flies. After consultation with USDA and other scientists, 
and careful review of the research, APHIS has determined that 150 Gray 
is an appropriate dose for several other species of fruit flies, 
including four species of Anastrepha and three other species of 
Bactrocera. However, we do not believe that the available information 
is adequate to support the adoption of 150 Gray as a generic dose for 
all fruit flies, given the level of quarantine security required by 
APHIS.
    APHIS is hopeful that additional research and better information 
can be provided to support the adoption of lower doses, possibly below 
150 Gray. Information of this nature will be considered by APHIS as it 
becomes

[[Page 36971]]

available, and treatment requirements will be adjusted to reflect the 
lowest possible effective dose that is deemed to be both operationally 
practical and scientifically supportable for the level of quarantine 
security required by APHIS for the pests of concern, including fruit 
flies. However, at this time, we have determined that, based on 
research, quarantine security requires an irradiation dosage of 250 
Gray as an appropriate dose to achieve probit 9 efficacy. Therefore, we 
are making no changes to the proposed rule in response to this comment.
    Comment: The increased irradiation dose of 250 Gray will not kill 
all fruit fly larvae in shipments of fruit from Hawaii and is not in 
line with the Notice of Policy, The Application of Irradiation to 
Phytosanitary Problems, as published in the Federal Register on May 15, 
1996 (61 FR 24433-24439, Docket No. 95-088-1).
    Response: We agree that a dose of 250 Gray will not kill all Trifly 
larvae in the shipments, but research and test treatments under 
commercial conditions demonstrate that a high percentage of larvae will 
in fact be killed when treated with a 250 Gray minimum dose. This is 
because, under commercial conditions, most of the treated lot will 
receive a dose two to three times the minimum in order to ensure that 
the low point in the load receives the minimum dose. However, the 
endpoint for quarantine security that has been adopted by APHIS is not 
larval mortality, but the inability of adults to emerge from fruit. We 
are confident that the research adequately supports 250 Gray as an 
appropriate dose to achieve probit 9 efficacy.
    Regarding a possible contradiction of one or more of the policy 
statements contained in the Notice of Policy, The Application of 
Irradiation to Phytosanitary Problems, the policy notice referred to by 
the commenter states the intent of the Agency is to avoid regulatory 
overlap, conflict, and ambiguity through cooperation and by harmonizing 
requirements across agency, domestic, and international lines of 
authority. This is in recognition of the range of authorities involved 
with irradiation and the complexity of requirements placed on the 
irradiation industry. APHIS remains committed to this policy in the 
subject rule and as a standard for regulatory initiatives in general. 
For example, the role of the Food and Drug Administration and Nuclear 
Regulatory Commission is acknowledged and well-integrated into the 
authorization for the irradiation of Hawaiian fruits and vegetables 
(see Sec. 318.13-4f(e)).
    The issue of quarantine security, however, is clearly central to 
the charge and authority of APHIS. It is in this regard that the 
decision concerning dose becomes a function of APHIS' positions on the 
desired level of protection and the degree of confidence placed on 
information used to support various proposals. The primary principles 
to consider in this respect are consistency, equivalency, and the risk 
basis for requirements. However, the doses adopted by APHIS in some 
instances may vary from those adopted by other countries or the 
recommendations of international organizations when APHIS determines 
that there is a high risk which justifies and supports an increased 
level of protection. APHIS' doses are believed to be consistent with 
the level of quarantine security and the quality of supporting data 
used for similar treatment situations. APHIS remains open to any new 
information that may lead to lower dose levels and greater 
harmonization. However, at this time, we are making no changes to the 
proposed rule in response to this comment.
    Comment: Technical corrections need to be made regarding the 
irradiation terminology (ASTM) in the proposal.
    Response: We agree that technical corrections, including the 
replacement of the term ``dose indicator'' with the term ``dosimeter'' 
in Sec. 318.13-4f(b)(6)(ii) and the amendment of footnote 6 of the rule 
portion of this document, need to be made in our irradiation 
terminology. Accordingly, we are amending Sec. 318.13-4f(b)(6)(ii) to 
read ``dosimeter'' instead of ``dose indicator,'' and footnote 6 to 
read ``Designation E 1261, `Standard Guide for Selection and 
Calibration of Dosimetry Systems for Radiation Processing,' American 
Society for Testing and Materials, Annual Book of ASTM Standards.''
    Comment: Only fruit (no leaves or stems) from Hawaii should be 
allowed to enter the mainland United States because fruit flies and 
other plant pests may hide in leaves and stems.
    Response: We are only allowing the fruit of carambola, litchi, and 
papaya from Hawaii to move interstate to the mainland United States. It 
is customary in shipping such fruits that only the fruit, without 
leaves, stems, or other plant parts, be packaged in a shipment. 
Therefore, we are making no changes to the proposed rule in response to 
this comment.
    Comment: Will you allow non-fruit fly host material, such as 
pineapples, in the same shipment as treated fruit?
    Response: Untreated fruit, whether fruit fly host material or not, 
must not be packed in the same carton as treated fruit (see 
Sec. 318.13-4f(b)(2)(ii)). Non-fruit fly host material may be moved in 
the same pallet load as treated fruit because there is negligible risk 
that non-fruit fly host material would contain fruit flies that could 
re-infest treated fruit and because treated fruit must move to the 
mainland United States in pest-proof cartons.
    Comment: The criteria for the locations of future mainland 
irradiation treatment facilities should be in line with the criteria 
for locations of cold treatment facilities to prevent the introduction 
and establishment of fruit flies on the mainland United States.
    Response: We believe that fruit fly host material moving to the 
mainland United States from Hawaii for irradiation treatment should be 
allowed to be treated only at those locations that will not support the 
establishment of successive generations of fruit flies. At this time, 
we are limiting the areas where irradiation treatment may be conducted 
on the mainland United States to States other than Alabama, Arizona, 
California, Florida, Georgia, Kentucky, Louisiana, Mississippi, Nevada, 
New Mexico, North Carolina, South Carolina, Tennessee, Texas, or 
Virginia. However, we are considering the possibility of allowing 
irradiation facilities to operate in other locations on the mainland 
United States where cold treatment of fruit flies has been approved.
    Comment: Changing the definition of ``inspector'' will reduce the 
standard of inspection.
    Response: Our proposed revision to the definition of ``inspector'' 
will allow State cooperators to inspect and issue limited permits for 
fruit moving interstate from Hawaii under our regulations. To be 
eligible for designation as an inspector under the regulations, a State 
plant regulatory official must have a bachelor's degree in the 
biological sciences, a minimum of 2 years' experience in State plant 
regulatory activities, and a minimum of 2 years' experience in 
recognizing and identifying plant pests known to occur within Hawaii. 
Six years' experience in State plant regulatory activities may be 
substituted for the degree requirement. As explained in our proposed 
rule, these requirements are based on the qualifications in 7 CFR 353 
for State plant regulatory officials who provide phytosanitary 
certification for plants and plant products exported from the United 
States. We believe our expanded definition of ``inspector'' will 
facilitate the inspection process while continuing to provide 
protection against the spread of injurious plant pests from Hawaii to 
other parts of the United States.

[[Page 36972]]

Therefore, we are making no changes to the proposed rule in response to 
this comment.
    We are also making nonsubstantive editorial changes for clarity.
    We feel confident that with the provisions outlined in our proposal 
and in this document, carambola, litchi, and papaya can move interstate 
from Hawaii to the mainland United States without presenting a 
significant risk of pest introduction or establishment on the mainland 
United States.
    Therefore, based on the rationale set forth in the proposed rule 
and in this document, we are adopting the provisions of the proposal as 
a final rule with the changes discussed above.

Effective Date

    Though this rule does change certain irradiation dosage and 
packaging requirements for papaya treated in Hawaii, there are 
currently no irradiation facilities in Hawaii to treat papaya; 
therefore, no one will be adversely affected by this rule. The other 
provisions contained in this rule relieve restrictions on the 
interstate movement of papaya, carambola, and litchi from Hawaii to the 
mainland United States. As such, this is a substantive rule that 
relieves restrictions and, pursuant to the provisions of 5 U.S.C. 553, 
may be made effective less than 30 days after publication in the 
Federal Register. Immediate implementation of this rule is necessary to 
provide relief to those persons who are adversely affected by 
restrictions we no longer find warranted. The shipping season for 
litchi from Hawaii began in May and continues through August. Making 
this rule effective immediately will allow interested producers and 
others in the marketing chain to benefit during this year's shipping 
season. Therefore, the Administrator of the Animal and Plant Health 
Inspection Service has determined that this rule should be effective 
upon publication in the Federal Register.

Executive Order 12866 and Regulatory Flexibility Act

    This rule has been reviewed under Executive Order 12866. The rule 
has been determined to be not significant for purposes of Executive 
Order 12866 and, therefore, has not been reviewed by the Office of 
Management and Budget.
    In accordance with 5 U.S.C. 604, we have performed a Final 
Regulatory Flexibility Analysis, which is set out below, regarding the 
impact of this final rule on small entities.
    In accordance with 7 U.S.C. 162, the Secretary of Agriculture is 
authorized to promulgate regulations governing the interstate movement 
of plants and plant products from a State or territory of the United 
States to prevent the spread of a dangerous plant disease or insect 
infestation new to or not widely prevalent or distributed within or 
throughout the United States.
    This rule amends the regulations by increasing the irradiation 
treatment dose required for papayas intended for interstate movement 
from Hawaii, by allowing carambolas to be moved interstate from Hawaii 
with irradiation treatment, and by allowing litchis to be moved 
interstate from Hawaii if they are inspected and found free of the 
litchi fruit moth and other plant pests and undergo irradiation or hot 
water treatment for fruit flies. We are allowing papayas, carambolas, 
and litchis from Hawaii to undergo irradiation treatment either in 
Hawaii or in non-fruit fly supporting areas of the mainland United 
States. In addition, we are making several amendments to the 
requirements for irradiation procedures and facilities and the handling 
of treated and untreated fruits and vegetables. Finally, this rule 
amends the definition for inspector to include State plant regulatory 
officials designated by the Administrator of the Animal and Plant 
Health Inspection Service, U.S. Department of Agriculture. These 
actions will facilitate the interstate movement of papayas, carambolas, 
and litchis from Hawaii while continuing to provide protection against 
the spread of injurious plant pests from Hawaii to other parts of the 
United States. Economic impacts associated with this rulemaking will 
largely be the result of untreated papayas, carambolas, or litchis 
being allowed to move to the mainland United States for irradiation 
treatment.
    In our proposal, we solicited comments on the potential effects of 
the proposed action on small entities. In particular, we sought data 
and other information to determine the number and kind of small 
entities that may incur benefits or costs from the implementation of 
the proposed rule. We received one comment on the Initial Regulatory 
Flexibility Analysis contained in the proposed rule. The commenter said 
that our determination that the proposal was not economically 
significant was incorrect; the commenter remarked that the provisions 
of the proposal are economically significant, particularly if, after 
the adoption of the proposal, a pest eradication program must commence.
    We believe that the treatment and other procedures established in 
this rule for the interstate movement of carambola, litchi, and papaya 
will mitigate the risk of pest introduction and establishment on the 
mainland United States. Therefore, we do not believe that a pest 
eradication program will be necessary as a result of this rule, or that 
the rule will otherwise have a significant economic impact on U.S. 
entities, large or small. As discussed below, Hawaii produces a small 
quantity of carambola and litchi when compared to the production of 
these commodities in the rest of the United States, and Hawaiian papaya 
shipments to the mainland United States totaled less than half of the 
quantity of papaya that the United States imported from foreign nations 
in 1994.

Papayas

    Papayas are produced commercially on about 340 farms in Hawaii. 
Nearly 65 percent of those farms are owned by individuals whose major 
occupation is not farming, while the balance are operated by 
individuals whose major occupation is farming.
    Papaya farms with average annual revenues of less than $500,000 are 
considered small. All papaya farms in Hawaii are therefore considered 
small.
    In 1994, Hawaii produced 62 million pounds of papaya (valued at $15 
million). Fresh papaya comprised 56.2 million pounds of this total. 
During that year, Hawaii shipped about 37.8 million pounds of papaya. 
Shipment of fresh papaya to the mainland totaled about 19.4 million 
pounds, and the remainder was exported to other countries. Of the 
approximately 19.4 million pounds of fresh papayas shipped from Hawaii 
to the mainland in 1994, most went to the West Coast. Seventy-five 
percent of them were sold directly to retailers, and the rest were sold 
to wholesalers.
    The United States imported about 41.2 million pounds of fresh 
papaya (valued at $10.9 million) in 1994. Most of the imported papayas 
came from Mexico (80 percent), Belize (9.6 percent), Jamaica (6.3 
percent), and the Dominican Republic (1.9 percent). The United States 
exported 18.4 million pounds of fresh papayas (valued at $15.4 million) 
in 1994. The major importers were Japan (66.8 percent) and Canada (27.1 
percent). Almost all United States exports of papayas go out of Hawaii, 
while all imports come into the mainland United States.
    There are five firms currently operating nine papaya treatment 
facilities in the State of Hawaii. Four firms use the vapor-heat 
treatment method and one uses the dry heat (or high-temperature forced 
air) method. The total capacity of these treatment chambers is 85,000 
pounds per run.

[[Page 36973]]

    Both heat treatment methods have the potential to damage the 
papayas. They require the center of each papaya fruit to reach about 47 
 deg.C (about 117  deg.F), a temperature sufficient to kill fruit fly 
eggs and larvae. Because of variation in fruit size and ripeness, the 
papayas may not be uniformly heated. This may result in the fruit 
becoming lumpy and losing flavor. For both methods, careful control of 
the uniformity of fruit size and ripeness is necessary for effective 
treatment. In addition, both methods require between 4 and 6 hours of 
treatment. Efforts to speed up the process result in fruit which is 
either scalded externally or hardened on the inside. The cost of 
treatment for both methods ranges from 9 to 23 cents per pound.
    Although the regulations currently allow papayas to be treated by 
irradiation in Hawaii, there are no irradiation facilities in that 
State. Allowing irradiation to be performed on the mainland appears to 
be an attractive option. The subsequent diversion of untreated papayas 
from Hawaii to the mainland would likely result in loss of business to 
the existing vapor heat and dry heat facilities. This could result in 
lay-offs and possibly the shut-down of some of these facilities. 
However, if papaya producers respond by producing more papayas, 
continuing traditional treatment for some and shipping others for 
irradiation, this will not necessarily occur.

Carambolas

    The United States produced about 6 million pounds of carambola in 
1994, with a total value of approximately $4 million to $4.5 million. 
In the United States, carambola is grown on about 100 farms. All of 
these farms have a market value of less than $500,000 and are thus 
considered to be small businesses according to the Small Business 
Administration's size standards.
    In 1994, Hawaii produced only about 50,700 pounds of carambola, 
valued at approximately $38,000, on 30 farms. The provisions proposed 
in this rule concerning irradiation treatment of carambola fruits by 
the mainland facilities are expected to stimulate growth of the 
carambola industry in Hawaii and provide greater access to the larger 
mainland market.
    No economic impact on mainland carambola growers is anticipated, 
since the total Hawaii production of carambola is less than one percent 
of the mainland production. Therefore, even in the unlikely event that 
Hawaii could ship 100 percent of its production to the mainland, supply 
would only increase by less than one percent. However, mainland 
consumers would likely benefit from increased seasonal and regional 
availability, as well as from the increased variety of fresh carambola. 
Additionally, carambola growers in Hawaii would benefit from the 
opportunity to sell their product in a larger and more diverse market.
    This rule will enable carambola from Hawaii to be irradiated at an 
existing irradiation facility on the mainland and is not expected to 
impose additional costs on carambola producers in Hawaii. We expect 
that carambola producers in Hawaii will benefit from the proposed 
irradiation treatment because this treatment can deliver better product 
quality, extended shelf life of the fruit, and cost effective treatment 
of the fruit. However, the overall impact of the carambola provisions 
of the proposed rule is expected to be insignificant.

Litchis

    Litchis are produced commercially on 55 farms in Hawaii. In 1993, 
the United States produced about 770,000 pounds of litchi. Of that 
total, approximately 85,000 pounds was produced in Hawaii.
    Litchi farms with average annual revenues of less than $500,000 are 
considered small. All litchi farms in Hawaii are considered small.
    The litchi industry in Hawaii has been constrained by the lack of 
an approved treatment for fruit flies since the cancellation of 
ethylene dibromide in 1984. Approving irradiation treatment of litchis 
on the mainland is expected to stimulate growth of the industry and 
provide access to the larger mainland market. No information is 
available on the effect of approving inspection and hot water treatment 
as an alternative method for moving litchis interstate.
    The United States is a net importer of fresh litchi, with a total 
import of about 165,000 pounds in 1994. In 1994, nearly 70 percent of 
imported litchi came from Mexico; the remainder came from Israel. The 
total supply of litchi on the mainland is about 850,000 pounds. 
Wholesale prices of litchi range between $1.00 per pound and $4.50 per 
pound.
    The economic impact on mainland litchi growers and prices on the 
mainland will not be significant. Even in the unlikely event that 
Hawaii shipped 25 percent of its production to the mainland, supply 
will increase by only about 2.3 percent. However, mainland consumers 
will benefit from increased seasonal and regional availability, an 
increased variety of fresh litchi, and stable prices. Additionally, 
litchi growers in Hawaii will benefit from the increased opportunity to 
sell their product in a larger and more diverse market.
    According to recent research conducted by the ARS, irradiation 
appears to be an effective treatment option that does not require 
control of either fruit size or ripeness. Irradiation typically 
requires only 40 minutes for treatment. The irradiation method may be 
more cost effective depending on volume treated, because it costs only 
about 5 to 12 cents per pound.
    This rule is expected to benefit producers, since irradiation 
appears to offer a number of advantages over current treatment options, 
including greater flexibility of fruit size and ripeness, reduction in 
treatment time, improved effectiveness against pest infestation, better 
product quality, extended shelf life, and improved cost effectiveness. 
Consumers also may benefit from a better quality product. The overall 
impact upon supply, price, and competitiveness is expected to be 
insignificant.
    This rule contains information collection requirements. These were 
described in detail in the proposed rule as required by the Paperwork 
Reduction Act of 1995. Further, as required by that Act, we solicited 
public comment on the proposed information collection requirements and 
submitted them to the Office of Management and Budget for approval. See 
the statement in this document under the heading ``Paperwork Reduction 
Act.''
    The alternative to this rule is to take no action. We do not 
consider taking no action a reasonable alternative. Papayas may move 
interstate to the mainland United States only with thermal treatment, 
and carambolas and litchis are not currently moved interstate from 
Hawaii because of a lack of suitable treatment options. This rule will 
facilitate the interstate movement of papayas, carambolas, and litchis 
from Hawaii while continuing to provide protection against the spread 
of injurious plant pests from Hawaii to other parts of the United 
States.

Executive Order 12372

    This program/activity is listed in the Catalog of Federal Domestic 
Assistance under No. 10.025 and is subject to Executive Order 12372, 
which requires intergovernmental consultation with State and local 
officials. (See 7 CFR part 3015, subpart V.)

Executive Order 12988

    This rule has been reviewed under Executive Order 12988, Civil 
Justice Reform. State and local laws and regulations that are 
inconsistent with this rule will be preempted. No

[[Page 36974]]

retroactive effect will be given to this rule. Administrative 
proceedings will not be required before parties may file suit in court 
challenging this rule.

Paperwork Reduction Act

    In accordance with section 3507(d) of the Paperwork Reduction Act 
of 1995 (44 U.S.C. 3501 et seq.), the information collection or 
recordkeeping requirements included in this final rule have been 
approved by the Office of Management and Budget (OMB). The assigned OMB 
control number is 0579-0123.

List of Subjects

7 CFR Part 300

    Incorporation by reference, Plant diseases and pests, Quarantine.

7 CFR Part 318

    Cotton, Cottonseeds, Fruits, Guam, Hawaii, Incorporation by 
reference, Plant diseases and pests, Puerto Rico, Quarantine, 
Transportation, Vegetables, Virgin Islands.

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

PART 300--INCORPORATION BY REFERENCE

    1. The authority citation continues to read as follows:

    Authority: 7 U.S.C. 150ee, 154, 161, 162, and 167; 7 CFR 2.22, 
2.80, and 371.2(c).

    2. In Sec. 300.1, paragraph (a), the introductory text is revised 
to read as follows:


Sec. 300.1  Materials incorporated by reference; availability.

    (a) Plant Protection and Quarantine Treatment Manual. The Plant 
Protection and Quarantine Treatment Manual, which was reprinted on 
November 30, 1992, and includes all revisions through April 1997, has 
been approved for incorporation by reference in 7 CFR chapter III by 
the Director of the Office of the Federal Register in accordance with 5 
U.S.C. 552(a) and 1 CFR part 51.
* * * * *

PART 318--HAWAIIAN AND TERRITORIAL QUARANTINE NOTICES

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

    Authority: 7 U.S.C. 150bb, 150dd, 150ee, 150ff, 161, 162, 164a, 
and 167; 7 CFR 2.22, 2.80, and 371.2(c).

    4. In Sec. 318.13-1, the definition for Inspector is amended to 
read as follows:


Sec. 318.13-1  Definitions.

* * * * *
    Inspector. An employee of Plant Protection and Quarantine, or a 
State plant regulatory official designated by the Administrator to 
inspect and certify to shippers and other interested parties, as to the 
condition of the products inspected. To be eligible for designation, a 
State plant regulatory official must have a bachelor's degree in the 
biological sciences, a minimum of 2 years' experience in State plant 
regulatory activities, and a minimum of 2 years' experience in 
recognizing and identifying plant pests known to occur within Hawaii. 
Six years' experience in State plant regulatory activities may be 
substituted for the degree requirement.
* * * * *
    5. In Sec. 318.13-3, a new paragraph (b)(3) is added to read as 
follows:


Sec. 318.13-3  Conditions of movement.

* * * * *
    (b) * * *
    (3) Untreated fruits and vegetables from Hawaii may be moved 
interstate for irradiation treatment on the mainland United States if 
the provisions of Sec. 318.13-4f are met and if the fruits and 
vegetables are accompanied by a limited permit issued by an inspector 
in accordance with Sec. 318.13-4(c). The limited permit will be issued 
only if the inspector examines the shipment and determines that the 
shipment has been prepared in compliance with the provisions of this 
subpart.
* * * * *
    6. A new Sec. 318.13-4e is added to read as follows:


Sec. 318.13-4e  Administrative instructions governing the movement of 
litchis from Hawaii to other States.

    (a) Litchis may be moved interstate from Hawaii only in accordance 
with this section or Sec. 318.13-4f and all other applicable provisions 
of this part.
    (b) To be eligible for interstate movement under this section, 
litchi must be inspected and found free of the litchi fruit moth 
(Cryptophlebia spp.) and other plant pests by an inspector and then 
treated for fruit flies under the supervision of an inspector with a 
treatment listed in the Plant Protection and Quarantine Treatment 
Manual, which is incorporated by reference at Sec. 300.1 of this 
chapter.
    (c) Litchi from Hawaii may not be moved interstate into Florida. 
All cartons in which litchi from Hawaii are packed must be stamped 
``Not for importation into or distribution in FL.''
    7. Section 318.13-4f is revised to read as follows:


Sec. 318.13-4f  Administrative instructions prescribing methods for 
irradiation treatment of certain fruits and vegetables from Hawaii.

    (a) Approved irradiation treatment. Irradiation, carried out in 
accordance with the provisions of this section, is approved as a 
treatment for the following fruits and vegetables: carambola, litchi, 
and papaya.
    (b) Conditions of movement. Fruits and vegetables from Hawaii may 
be authorized for movement in accordance with this section only if the 
following conditions are met:
    (1) Location. The irradiation treatment must be carried out at an 
approved facility in Hawaii or on the mainland United States. Fruits 
and vegetables authorized under this section for treatment on the 
mainland may be treated in any State on the mainland United States 
except Alabama, Arizona, California, Florida, Georgia, Kentucky, 
Louisiana, Mississippi, Nevada, New Mexico, North Carolina, South 
Carolina, Tennessee, Texas, or Virginia. Prior to treatment, the fruits 
and vegetables may not move into or through Alabama, Arizona, 
California, Florida, Georgia, Kentucky, Louisiana, Mississippi, Nevada, 
New Mexico, North Carolina, South Carolina, Tennessee, Texas, or 
Virginia, except that movement is allowed through Dallas/Fort Worth, 
Texas, as an authorized stop for air cargo, or as a transloading 
location for shipments that arrive by air but that are subsequently 
transloaded into trucks for overland movement from Dallas/Fort Worth 
into an authorized State by the shortest route.
    (2) Approved facility. The irradiation treatment facility and 
treatment protocol must be approved by the Animal and Plant Health 
Inspection Service. In order to be approved, a facility must:
    (i) Be capable of administering a minimum absorbed ionizing 
radiation dose of 250 Gray (25 krad) to the fruits and 
vegetables;2
---------------------------------------------------------------------------

    \2\ The maximum absorbed ionizing radiation dose and the 
irradiation of food is regulated by the Food and Drug Administration 
under 21 CFR part 179.
---------------------------------------------------------------------------

    (ii) Be constructed so as to provide physically separate locations 
for treated and untreated fruits and vegetables, except that fruits and 
vegetables traveling by conveyor directly into the irradiation chamber 
may pass through an area that would otherwise be separated. The 
locations must be separated by a permanent physical barrier such as a 
wall or chain link fence six or more feet high to prevent transfer of 
cartons. Untreated fruits and vegetables shipped to the mainland United 
States from Hawaii in

[[Page 36975]]

accordance with this section may not be packaged for shipment in a 
carton with treated fruits and vegetables;
    (iii) Complete a compliance agreement with the Animal and Plant 
Health Inspection Service as provided in Sec. 318.13-4(d) of this 
subpart; and
    (iv) Be certified by Plant Protection and Quarantine for initial 
use and annually for subsequent use. Recertification is required in the 
event that an increase or decrease in radioisotope or a major 
modification to equipment that affects the delivered dose. 
Recertification may be required in cases where a significant variance 
in dose delivery is indicated.
    (3) Treatment monitoring. Treatment must be carried out under the 
monitoring of an inspector. This monitoring must include inspection of 
treatment records and unannounced inspectional visits to the facility 
by an inspector. Facilities that carry out continual irradiation 
operations must notify an inspector at least 24 hours before the date 
of operations. Facilities that carry out periodic irradiation 
operations must notify an inspector of scheduled operations at least 24 
hours before scheduled operations.\3\
---------------------------------------------------------------------------

    \3\ Inspectors are assigned to local offices of the Animal and 
Plant Health Inspection Service, which are listed in telephone 
directories.
---------------------------------------------------------------------------

    (4) Packaging. (i) Fruits and vegetables that are treated in Hawaii 
must be packaged in the following manner:
    (A) The cartons must have no openings that will allow the entry of 
fruit flies and must be sealed with seals that will visually indicate 
if the cartons have been opened. They may be constructed of any 
material that prevents the entry of fruit flies and prevents 
oviposition by fruit flies into the fruit in the carton.4
---------------------------------------------------------------------------

    \4\ If there is a question as to the adequacy of a carton, send 
a request for approval of the carton, together with a sample carton, 
to the Animal and Plant Health Inspection Service, Plant Protection 
and Quarantine, Phytosanitary Issues Management Team, 4700 River 
Road Unit 140, Riverdale, Maryland 20737-1236.
---------------------------------------------------------------------------

    (B) The pallet-load of cartons must be wrapped before it leaves the 
irradiation facility in one of the following ways:
    (1) With polyethylene sheet wrap;
    (2) With net wrapping; or
    (3) With strapping so that each carton on an outside row of the 
pallet load is constrained by a metal or plastic strap.
    (C) Packaging must be labeled with treatment lot numbers, packing 
and treatment facility identification and location, and dates of 
packing and treatment.
    (ii) Cartons of untreated fruits and vegetables that are moving to 
the mainland United States for treatment must be shipped in shipping 
containers sealed prior to interstate movement with seals that will 
visually indicate if the shipping containers have been opened.
    (iii) Litchi from Hawaii may not be moved interstate into Florida. 
All cartons in which litchi from Hawaii are packed must be stamped 
``Not for importation into or distribution in FL.''
    (5) Dosage. The fruits and vegetables must receive a minimum 
absorbed ionizing radiation dose of 250 Gray (25 krad).5
---------------------------------------------------------------------------

    \5\ See footnote 2.
---------------------------------------------------------------------------

    (6) Dosimetry systems. (i) Dosimetry must demonstrate that the 
absorbed dose, including areas of minimum and maximum dose, is mapped, 
controlled, and recorded.
    (ii) Absorbed dose must be measured using a dosimeter that can 
accurately measure an absorbed dose of 250 Gray (25 krad).
    (iii) The number and placement of dosimeters used must be in 
accordance with American Society for Testing and Materials (ASTM) 
standards.6
---------------------------------------------------------------------------

    \6\ Designation E 1261, ``Standard Guide for Selection and 
Calibration of Dosimetry Systems for Radiation Processing,'' 
American Society for Testing and Materials, Annual Book of ASTM 
Standards.
---------------------------------------------------------------------------

    (7)(i) Certification on basis of treatment. A certificate shall be 
issued by an inspector for the movement of fruits and vegetables from 
Hawaii that have been treated and handled in Hawaii in accordance with 
this section. To be certified for interstate movement under this 
section, litchi from Hawaii must be inspected in Hawaii and found free 
of the litchi fruit moth (Cryptophlebia spp.) and other plant pests by 
an inspector before undergoing irradiation treatment in Hawaii for 
fruit flies.
    (ii) Limited permit. A limited permit shall be issued by an 
inspector for the interstate movement of untreated fruits and 
vegetables from Hawaii for treatment on the mainland United States in 
accordance with this section. To be eligible for a limited permit under 
this section, untreated litchi from Hawaii must be inspected in Hawaii 
and found free of the litchi fruit moth (Cryptophlebia spp.) and other 
plant pests by an inspector.
    (8) Records. Records or invoices for each treated lot must be made 
available for inspection by an inspector during normal business hours 
(8:00 a.m. to 4:30 p.m., Monday through Friday, except holidays). An 
irradiation processor must maintain records as specified in this 
section for a period of time that exceeds the shelf life of the 
irradiated food product by 1 year, and must make these records 
available for inspection by an inspector. These records must include 
the lot identification, scheduled process, evidence of compliance with 
the scheduled process, ionizing energy source, source calibration, 
dosimetry, dose distribution in the product, and the date of 
irradiation.
    (c) Request for approval and inspection of facility. Persons 
requesting approval of an irradiation treatment facility and treatment 
protocol must submit the request for approval in writing to the Animal 
and Plant Health Inspection Service, Plant Protection and Quarantine, 
Oxford Plant Protection Center, 901 Hillsboro St., Oxford, NC 27565. 
Before the Administrator determines whether an irradiation facility is 
eligible for approval, an inspector will make a personal inspection of 
the facility to determine whether it complies with the standards of 
paragraph (b)(2) of this section.
    (d) Denial and withdrawal of approval. (1) The Administrator will 
withdraw the approval of any irradiation treatment facility when the 
irradiation processor requests in writing the withdrawal of approval.
    (2) The Administrator will deny or withdraw approval of an 
irradiation treatment facility when any provision of this section is 
not met. Before withdrawing or denying approval, the Administrator will 
inform the irradiation processor in writing of the reasons for the 
proposed action and provide the irradiation processor with an 
opportunity to respond. The Administrator will give the irradiation 
processor an opportunity for a hearing regarding any dispute of a 
material fact, in accordance with rules of practice that will be 
adopted for the proceeding. However, the Administrator will suspend 
approval pending final determination in the proceeding, if he or she 
determines that suspension is necessary to prevent the spread of any 
dangerous insect infestation. The suspension will be effective upon 
oral or written notification, whichever is earlier, to the irradiation 
processor. In the event of oral notification, written confirmation will 
be given to the irradiation processor within 10 days of the oral 
notification. The suspension will continue in effect pending completion 
of the proceeding and any judicial review of the proceeding.
    (e) Department not responsible for damage. This treatment is 
approved to assure quarantine security against the Trifly complex. From 
the literature available, the fruits and vegetables authorized for 
treatment under this section are believed tolerant to the treatment; 
however, the facility operator

[[Page 36976]]

and shipper are responsible for determination of tolerance. The 
Department of Agriculture and its inspectors assume no responsibility 
for any loss or damage resulting from any treatment prescribed or 
supervised. Additionally, the Nuclear Regulatory Commission is 
responsible for ensuring that irradiation facilities are constructed 
and operated in a safe manner. Further, the Food and Drug 
Administration is responsible for ensuring that irradiated foods are 
safe and wholesome for human consumption.

    Done in Washington, DC, this 30th day of June 1997.
Terry L. Medley,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 97-17672 Filed 7-9-97; 8:45 am]
BILLING CODE 3410-34-U