[Federal Register: February 5, 2003 (Volume 68, Number 24)]
[Rules and Regulations]
[Page 5796-5800]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05fe03-3]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
7 CFR Part 318
[Docket No. 00-052-2]
Fruits and Vegetables From Hawaii
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Final rule.
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SUMMARY: We are amending the regulations to allow bell peppers,
eggplant, mangoes, pineapple (other than smooth Cayenne), Italian
squash, and tomatoes to be moved interstate from Hawaii if the fruits
and vegetables undergo irradiation treatment at an approved facility.
Treatment may be conducted either in Hawaii or in areas of the mainland
United States where tropical fruit flies are not likely to become
established. The fruits and vegetables will also have to meet certain
additional requirements, including packaging requirements. This action
relieves restrictions on the movement of these fruits and vegetables
from Hawaii while continuing to provide protection against the spread
of plant pests from Hawaii to other parts of the United States.
EFFECTIVE DATE: February 5, 2003.
FOR FURTHER INFORMATION CONTACT: Mr. Hesham A. Abuelnaga, Import
Specialist, Phytosanitary Issues Management Team, PPQ, APHIS, 4700
River Road Unit 140, Riverdale, MD 20737-1236; (301) 734-5334.
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 from Hawaii. Regulation is necessary to prevent the spread
of dangerous plant diseases and pests that occur in Hawaii.
The regulations in Sec. 318.13-4f allow abiu, atemoya, carambola,
litchi, longan, papaya, rambutan, and sapodilla to be moved interstate
from Hawaii if, among other things, the fruits and vegetables undergo
irradiation treatment in accordance with that section.
On May 22, 2002, we published in the Federal Register (67 FR 35932-
35936, Docket No. 00-052-1) a proposal to amend the regulations to
allow bell peppers, eggplant, mangoes, pineapple (other than smooth
Cayenne), Italian squash, and tomatoes to be moved interstate from
Hawaii if treated with irradiation in accordance with the requirements
in Sec. 318.13-4f. The proposal was prompted by research by the
Department's Agricultural Research Service (ARS) that showed that this
irradiation treatment could eliminate infestations of fruit flies and
other pests in those commodities. In that same document, we also
proposed to amend the irradiation regulations to require cartons of
fruits and vegetables that are being moved interstate in accordance
with the regulations to be marked with irradiation indicators.
We solicited comments concerning our proposal for 60 days ending
July 22, 2002. We received six comments by that date. The comments were
from researchers, a manufacturer of irradiation equipment, and
representatives of a State government. The commenters generally
supported the proposal. However, four commenters expressed concern over
the proposed requirement for the use of
[[Page 5797]]
irradiation indicators. Also, another commenter raised concerns about
including mangoes on the list of fruits approved for movement from
Hawaii if treated with irradiation. These comments are discussed below
by topic.
Irradiation Indicators
We proposed to amend the irradiation provisions in Sec. 318.13-4f
to require cartons of fruits and vegetables being moved interstate in
accordance with the regulations to be marked with irradiation
indicators. Specifically, we had proposed to add a new Sec. 318.13-
4f(b)(7) to read as follows: ``Indicators. Each carton of fruits and
vegetables must bear an indicator device, securely attached prior to
irradiation, that changes color or provides another clear visual change
when it is exposed to radiation in the dose range required by this
section for the pests for which the articles are being treated.'' Four
commenters opposed this proposed requirement for numerous technical,
operational, and cost-benefit reasons.
One commenter referred to several studies that deal with the
limitations of available radiation-sensitive indicators.\1\
Specifically, the commenter stated that dose fluctuations resulting
from density variations caused by the arrangement, size, and weight of
individual fruit within the subunits of a pallet would make irradiation
indicators impractical and unreliable.
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\1\ Ehlermann, D.A.E. (Federal Research Centre for Nutrition,
Karlsruhe (Germany). Inst. of Process Engineering), ``Validation of
a label dosimeter for food irradiation applications by subjective
and objective means,'' Appl. Radiat. Isot.; v. 48(9), p. 1197-1201;
1997.
International Atomic Energy Agency, ``Standardized methods to
verify absorbed dose in irradiated food for insect control,'' IAEA,
Vienna, 2001, IAEA-TECDOC-1201.
Razem, D. (Ruder Boskovic Inst., Zagreb (Croatia)), ``Dosimetric
performance of and environmental effects on sterin irradiation
indicator labels,'' Radiat. Phys. Chem.; v.49(4), p. 491-495.
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Another commenter stated that the indicators that are currently
available have not undergone adequate testing and standard development,
and, therefore, their reliability is questionable. In addition, the
commenter suggested that the added labor costs for the additional
handling must be taken into account, offsetting the low cost of the
production of the indicators themselves.
One comment, which was reviewed and submitted by several
researchers, offered detailed discussion of several issues related to
the use of irradiation indicators. The comment referred to American
Society for Testing and Materials (ASTM) Standard E 1539-98, ``Standard
Guide for the Use of Radiation-Sensitive Indicators.'' Section 7.3 of
that document states: ``Some irradiation or storage conditions may
result in false positive or negative observations. For these reasons,
indicators should not be used as a criterion for product release. Also,
external environmental influences may make the interpretation of the
indicators meaningless outside the irradiation facility unless
appropriate controls are used.'' The commenter indicated that, for
several technical reasons, irradiation indicators can only be used
effectively to show that products have been exposed to ``some''
radiation, and not to show the exact dose of radiation that a product
has received.
We have carefully analyzed all the data and opinions submitted
recommending against the proposed indicator requirement and have
decided to omit that requirement from this final rule. While we believe
that an indicator could be employed as a useful ``cross check'' when
Animal and Plant Health Inspection Service (APHIS) inspectors are
correlating the required interstate movement certificates with the
cartons referred to in those documents to offer additional protection
against the introduction of plant pests into the mainland United States
from Hawaii, apparently there is no such indicator that is: (1)
Currently available at low cost; (2) validated to be sensitive and
reliable in the appropriate dose ranges; and (3) validated to be
resistant to false positives and false negatives caused by
environmental effects. Therefore, we have omitted proposed Sec.
318.13-4f(b)(7) from this final rule.
Dosage Recommendations
One commenter noted that there are only two studies to date that
examine the relationship between radiation dose and fertility in the
adult mango seed weevil (Sternochetus mangiferae (Fabricus), formerly
known as Cryptorhynchus mangiferae). The commenter stated that these
studies do not provide adequate support for the proposed dose of 100 Gy
(10 krad), which was recommended by ARS research findings as a
sufficient quarantine treatment for mango seed weevil. The commenter
suggested that, based on the limited amount of research that has been
done, Hawaiian mangoes should be subjected to higher doses of radiation
than 100 Gy (10 krad). We had proposed a minimum ionizing irradiation
dose of 250 Gy (25 krad) for mangoes, which we indicated would be
effective in eliminating both fruit flies and the mango seed weevil.
We have carefully analyzed the data and conducted a review of the
available literature on this topic and have determined that a higher
dose of irradiation for mango seed weevil is appropriate. Based on
research by ARS (Follett, 1999) and by the International Consultative
Group on Food Irradiation of the Food and Agriculture Organization of
the United Nations,\2\ we are setting an irradiation dose level of 300
Gy (30 krad) for mango seed weevil in this final rule. We believe that
there is enough research and evidence to support this dose level as an
effective quarantine treatment for mango seed weevil.
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\2\ ``Irradiation as a Quarantine Treatment of Fresh Fruits and
Vegetables,'' ICGFI, 1991. This publication also cited two other
studies, (Heather and Corcoran, 1990) and (Jessup and Rigney, 1990),
that supported an irradiation dose level of 300 Gy (30 krad) for
mango seed weevil.
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The same commenter also stated that a dose of 250 Gy is excessive
for fruit flies. He indicated that ``recent research and analyses have
demonstrated that studies finding that doses 150 Gy were
needed most likely are in error,'' but did not identify specific
studies or analyses. He asked when APHIS would consider lower doses.
The research supporting this comment may have merit, but such
research must be carefully evaluated and verified before we lower doses
below the proposed level, which we know is effective. APHIS, in
cooperation with ARS and others, will evaluate the lower doses
recommended by this commenter. If we determine that lower doses are
effective for fruit flies, we will initiate rulemaking in the future to
reduce the doses. However, this evaluation process will take time, so
in this final rule we are utilizing the dose of 250 Gy for fruit flies
so that irradiation treatments may occur while this evaluation is
underway.
The same commenter also stated that there should be a range of time
given for irradiation treatment the way that a time range is given for
vapor heat treatment in the comparison table (see Table 3) in the
proposed rule. The commenter also asked if the comparison table
compared values for the same amount of fruit in both treatments.
The comparison table was offered in the proposed rule's economic
analysis to illustrate the relative cost and time-saving benefits of
irradiation treatments when compared to the presently available vapor
heat treatment, not to set specific values for the two treatments.
Although the same amount of fruit was used in both treatments, it was
not possible to give a time range for irradiation treatment comparable
to the time range given for the heat vapor treatment because of the
number of
[[Page 5798]]
variables involved in the irradiation process. The irradiation exposure
times that are necessary to ensure that the specified dose has been
delivered and absorbed vary widely by commodity and by equipment, which
is available from several different manufacturers of irradiation
equipment. The Plant Protection and Quarantine Treatment Manual, which
is incorporated by reference in 7 CFR Sec. 300.1, states that
irradiation facilities must use ASTM Standard E 1261, ``Guide for
Selection and Calibration of Dosimetry Systems for Radiation'' (or an
equivalent international standard) as a guide for selection and
calibration of an appropriate dosimetry system that matches the
dosimeter requirements specific to their needs, and that irradiation
exposure times must be evaluated for each commodity. The necessary
dosage levels vary from 150 Gy (15 krad) to 300 Gy (30 krad) based on
commodity, and each piece of equipment varies in the amount of time it
takes to ensure that these dosage levels have been delivered and
absorbed. Any time range given would not be able to take into account
all of these possibilities and would therefore be inaccurate. We are
not making any changes to the rule based on this comment.
Miscellaneous
The regulations in Sec. 318.13-4f currently specify 250 Gy (25
krad) as the minimum absorbed dose for all treated commodities.
Because, as noted above, we are setting the minimum absorbed dose for
mangoes at 300 Gy (30 krad), we have amended several paragraphs in
Sec. 318.13-4f so that they refer to ``the specified dose'' rather
than to 250 Gy (25 krad).
Therefore, for the reasons given in the proposed rule and in this
document, we are adopting the proposed rule as a final rule, with the
changes discussed in this document.
Effective Date
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.
This rule relieves restrictions on the interstate movement of bell
peppers, eggplant, mangoes, pineapple (other than smooth Cayenne),
Italian squash, and tomatoes from Hawaii to the mainland United States.
Making this rule effective immediately will allow interested producers,
as well as manufacturers of the irradiation equipment that will be used
to treat these articles, to benefit from trade as soon as possible.
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 the purposes of Executive
Order 12866 and, therefore, has not been reviewed by the Office of
Management and Budget.
We are amending the Hawaiian Fruits and Vegetables regulations to
allow bell peppers, eggplant, mangoes, pineapple (other than smooth
Cayenne), Italian squash, and tomatoes to be moved interstate from
Hawaii if they are treated with irradiation in accordance with the
regulations in Sec. 318.13-4f. Irradiation at certain dosages
eliminates infestations of pests in fruits and vegetables. Irradiation
also eliminates bacterial or fungal growth that can otherwise cause
accelerated spoilage and result in illness. Bacterial contamination can
come from soil, insects, bird or rodent droppings, or the water used in
processing.
Effects on Producers and Shippers of Fruits and Vegetables
Since 1995, the amount of land used for commercial production of
mangoes in Hawaii has nearly tripled, and more than 7,500 new mango
trees have been planted. However, producers in Hawaii have not been
able to ship mangoes to the mainland United States due to the presence
of the mango seed weevil in Hawaii (the mango seed weevil is not
present in the mainland United States).\3\ The irradiation treatment in
this final rule provides an effective quarantine treatment for the
mango seed weevil that will protect against the introduction and
dissemination of this pest into the mainland United States from Hawaii.
This final rule opens the mainland U.S. mango market to Hawaiian
mangoes.
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\3\ The mango seed weevil attacks mango seeds, but rarely the
fruit, and may cause slight fruit drop in production areas. The
mango seed weevil poses no threat to other crops or flora. It is
strictly monophagous.
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U.S. production of mangoes has primarily been in southern Florida,
with a smaller quantity grown in Hawaii and a negligible amount
produced in California. According to the 1997 Census of Agriculture,
there were 218 mango farms in Florida, 171 in Hawaii, and 2 in
California. The total domestic harvest that year was about 2,829 metric
tons, of which about 97 percent was produced in Florida and about 3
percent (approximately 85 metric tons) produced in Hawaii. According to
National Agricultural Statistics Service data, Hawaii produced
approximately 72 metric tons of mangoes in 1999. It is unlikely that
this final rule will result in a significant amount of mangoes being
moved from Hawaii to the mainland United States because it is expected
that nearly all mangoes produced in Hawaii will continue to be consumed
within the State. Further, given that the United States imported
219,000 metric tons of mangoes between September 1998 and August 1999,
any movements of Hawaii-grown mangoes to the mainland United States
will be insignificant in contrast to the volume of annual imports.
Bell peppers, eggplant, pineapple (other than smooth Cayenne),
Italian squash, and tomatoes are currently allowed to move interstate
from Hawaii if they are first treated for Mediterranean fruit fly,
oriental fruit fly, and melon fly with vapor heat in accordance with
Sec. 318.13-4b. Tomatoes may also be moved interstate from Hawaii if
they are treated with methyl bromide in accordance with Sec. 318.13-
4c. This rule provides for an alternative means of treating bell
peppers, eggplant, pineapple (other than smooth Cayenne), Italian
squash, and tomatoes from Hawaii for fruit flies and other pests.
Since 1995, Hawaii's production of bell peppers, eggplant, Italian
squash, and tomatoes has increased in value and volume (see tables 1
and 2). Hawaii's production of pineapples (other than smooth Cayenne)
has decreased by 4 percent, but its value has increased by 6 percent.
[[Page 5799]]
Table 1.--Production of Selected Vegetables in Hawaii
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Year
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1995 1996 1997 1998
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Bell Peppers
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Volume (fresh weight in lbs.)....... 2,400,000 2,600,000 2,000,000 3,000,000
Value............................... $1,392,000 $1,248,000 $980,000 $1,500,000
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Eggplant
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Volume (fresh weight in lbs.)....... 1,200,000 1,300,000 1,500,000 1,300,000
Value............................... $984,000 $949,000 $1,185,000 $1,053,000
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Pineapples (other than smooth Cayenne)
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Volume (fresh weight in lbs.)....... 760,594,590 765,003,834 714,297,528 731,934,504
Value............................... $87,360,000 $95,914,000 $91,721,000 $92,776,000
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Italian Squash
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Volume (fresh weight in lbs.)....... 620,000 700,000 1,400,000 1,500,000
Value............................... $316,000 $336,000 $700,000 $735,000
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Tomatoes
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Volume (fresh weight in lbs.)....... 6,000,000 7,000,000 10,200,000 10,200,000
Value............................... $2,910,000 $3,710,000 $5,508,000 $5,610,000
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Table 2.--Change in Production of Selected Vegetables in Hawaii Between
1995 and 1998
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Volume (percent) Value (percent)
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Bell peppers...................... -4 +6
Eggplant.......................... +70 +93
Pineapples (other than smooth +25 +8
Cayenne).........................
Italian squash.................... +8 +7
Tomatoes.......................... +142 +96
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According to the Hawaii Agricultural Census, there were 27 farms
growing pineapples for commercial sale in 1997. Twenty-two (or 82
percent) of those farms harvested between 1 and 14 acres of pineapple.
During the same year, 74 farms produced tomatoes for commercial sale (a
total of 388 acres harvested). There are no official data with respect
to the number of farms in Hawaii producing bell peppers, eggplant, and
Italian squash during the same year. However, considering that in 1997
there were 657 farms in Hawaii that harvested fruits and vegetables for
sale (90 percent of which had less than 14 acres of crops planted), we
believe that the majority of farms producing bell peppers, eggplant,
and Italian squash for sale were small according to Small Business
Administration (SBA) criteria. It is also likely that the majority of
firms shipping bell peppers, eggplant, and Italian squash interstate
from Hawaii are small according to SBA criteria.
Regardless of their size, Hawaii's fruit and vegetable producers
and shippers who move fruits and vegetables interstate from Hawaii will
benefit from the availability of an additional treatment alternative,
especially since this treatment is less time-consuming than the
presently available vapor heat treatment (see Table 3).
Table 3.--Comparison of Irradiation and Vapor Heat Treatments
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Irradiation Vapor heat
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Cost.......................... $0.22 to $0.33/kg $0.20 to $0.50/
(treatment cost). kg
Treatment Time................ 40 minutes............ 1.5 to 7 hours
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Effects on Treatment Facilities
The irradiation treatments for bell peppers, eggplants, mangoes,
pineapples (other than smooth Cayenne), Italian squash, and tomatoes
will take place mostly at a new facility that was recently built in
Hawaii. However, it is possible that some of these fruits and
vegetables could be shipped to the mainland United States and treated
with irradiation at facilities in Illinois or New Jersey. At present,
various other tropical fruits, such as papaya, litchi, rambutan,
carambola, and atemoya are shipped from Hawaii to a facility in
Illinois for cobalt irradiation treatment.
On August 1, 2000, a new x-ray irradiation facility in Hawaii began
treating papayas, which, after their x-ray treatment, are commercially
shipped to the mainland United States. This facility treats between 500
to 1,000 boxes of papayas per day, 4 days per week.
This facility will be the primary irradiation facility to treat
Hawaii-grown
[[Page 5800]]
bell peppers, eggplants, mangoes, pineapples (other than smooth
Cayenne), Italian squash, and tomatoes before they are moved
interstate. However, if there is not enough capacity at the Hawaiian
plant for the fruits to be irradiated, the fruits can be sent for
treatment to any of the three irradiation treatment facilities on the
mainland United States.
According to SBA criteria, the facility in Hawaii mentioned in the
previous paragraphs is a small entity (i.e., an entity with annual
sales of less than $5 million). Another firm that provides irradiation
treatments for fruits and vegetables owns two irradiation facilities in
Illinois and one facility in New Jersey. This other firm, which
primarily provides irradiation treatment to sanitize medical devices,
is not a small entity according to SBA criteria.
This final rule benefits the Hawaiian treatment facility, and may
benefit the mainland facilities if the Hawaiian facility cannot keep up
with demand for treatment of fruits and vegetables moving interstate
from Hawaii. The final rule could also potentially benefit U.S.
mainland consumers by increasing the mainland's supply of those fruits
and vegetables that will now be eligible for interstate movement with
irradiation treatment.
Under these circumstances, the Administrator of the Animal and
Plant Health Inspection Service has determined that this action will
not have a significant economic impact on a substantial number of small
entities.
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 final rule has been reviewed under Executive Order 12988,
Civil Justice Reform. This rule: (1) Preempts all State and local laws
and regulations that are inconsistent with this rule; (2) has no
retroactive effect; and (3) does not require administrative proceedings
before parties may file suit in court challenging this rule.
Paperwork Reduction Act
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C.
3501 et seq.), the information collection or recordkeeping requirements
included in this rule have been approved by the Office of Management
and Budget (OMB) under OMB control number 0579-0198. Government
Paperwork Elimination Act Compliance
The Animal and Plant Health Inspection Service is committed to
compliance with the Government Paperwork Elimination Act (GPEA), which
requires Government agencies in general to provide the public the
option of submitting information or transacting business electronically
to the maximum extent possible. For information pertinent to GPEA
compliance related to this rule, please contact Mrs. Celeste Sickles,
APHIS'' Information Collection Coordinator, at (301) 734-7477.
List of Subjects in 7 CFR Part 318
Cotton, Cottonseeds, Fruits, Guam, Hawaii, Plant diseases and
pests, Puerto Rico, Quarantine, Transportation, Vegetables, Virgin
Islands.
Accordingly, we are amending 7 CFR part 318 as follows:
PART 318--HAWAIIAN AND TERRITORIAL QUARANTINE NOTICES
1. The authority citation for part 318 continues to read as
follows:
Authority: 7 U.S.C. 7711, 7712, 7714, 7731, 7754, and 7756; 7
CFR 2.22, 2.80, and 371.3.
2. Section 318.13-4f is amended as follows:
a. By revising paragraphs (a), (b)(2)(i), (b)(5), and (b)(6)(ii) to
read as set forth below.
b. By adding, at the end of the section, the following: ``(Approved
by the Office of Management and Budget under control number 0579-
0198)''.
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 at the specified dose
levels:
Irradiation for Fruit Flies and Seed Weevils in Hawaiian Fruits and
Vegetables
------------------------------------------------------------------------
Dose
Fruit (gray)
------------------------------------------------------------------------
Abiu........................................................... 250
Atemoya........................................................ 250
Bell pepper.................................................... 250
Carambola...................................................... 250
Eggplant....................................................... 250
Litchi......................................................... 250
Longan......................................................... 250
Mango.......................................................... 300
Papaya......................................................... 250
Pineapple (other than smooth Cayenne).......................... 250
Rambutan....................................................... 250
Sapodilla...................................................... 250
Italian squash................................................. 250
Tomato......................................................... 250
------------------------------------------------------------------------
* * * * *
(b) * * *
(2) * * *
(i) Be capable of administering the minimum absorbed ionizing
radiation doses specified in paragraph (a) of this section to the
fruits and vegetables; \2\
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\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.
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* * * * *
(5) Dosage. The fruits and vegetables must receive the minimum
absorbed ionizing radiation dose specified in paragraph (a) of this
section.\5\
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\5\ See footnote 2.
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(6) * * *
(ii) Absorbed dose must be measured using a dosimeter that can
accurately measure the absorbed doses specified in paragraph (a) of
this section.
* * * * *
Done in Washington, DC this 30th day of January 2003.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 03-2681 Filed 2-4-03; 8:45 am]
BILLING CODE 3410-34-P