[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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Rules and Regulations
Federal Register
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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