[Title 7 CFR 305.2]
[Code of Federal Regulations (annual edition) - January 1, 2003 Edition]
[Title 7 - AGRICULTURE]
[Subtitle B - Regulations of the Department of Agriculture (Continued)]
[Chapter III - ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF]
[Part 305 - PHYTOSANITARY TREATMENTS]
[Sec. 305.2 - Irradiation treatment of imported fruits and vegetables for certain fruit flies and mango seed weevils.]
[From the U.S. Government Printing Office]
7AGRICULTURE52003-01-012003-01-01falseIrradiation treatment of imported fruits and vegetables for certain fruit flies and mango seed weevils.305.2Sec. 305.2AGRICULTURERegulations of the Department of Agriculture (Continued)ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OFPHYTOSANITARY TREATMENTS
Sec. 305.2 Irradiation treatment of imported fruits and vegetables for certain fruit flies and mango seed weevils.
(a) Approved doses. Irradiation at the following doses for the
specified fruit flies and seed weevils, carried out in accordance with
the provisions of this section, is approved as a treatment for all
fruits and vegetables:
Irradiation for Fruit Flies and Seed Weevils in Imported Fruits and
Vegetables
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Scientific name Common name Dose (gray)
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(1) Bactrocera dorsalis........ Oriental fruit fly..... 250
(2) Ceratitis capitata......... Mediterranean fruit fly 225
(3) Bactrocera cucurbitae...... Melon fly.............. 210
(4) Anastrepha fraterculus..... South American fruit 150
fly.
(5) Anastrepha suspensa........ Caribbean fruit fly.... 150
(6) Anastrepha ludens.......... Mexican fruit fly...... 150
(7) Anastrepha obliqua......... West Indian fruit fly.. 150
(8) Anastrepha serpentina...... Sapote fruit fly....... 150
(9) Bactrocera tryoni.......... Queensland fruit fly... 150
(10) Bactrocera jarvisi........ (No common name)....... 150
(11) Bactrocera latifrons...... Malaysian fruit fly.... 150
(12) Sternochetus mangiferae Mango seed weevil...... 300
(Fabricus).
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(b) Location of facilities. Where certified irradiation facilities
are available, an approved irradiation treatment may be conducted for
any fruit or vegetable either prior to shipment to the United States or
in the United States. Irradiation facilities certified under this
section may be located in any State on the mainland United States except
Alabama, Arizona, California, Florida, Georgia\1\, Kentucky, Louisiana,
Mississippi\1\, Nevada, New Mexico, North Carolina\1\, South Carolina,
Tennessee, Texas, and Virginia. Prior to treatment, the fruits and
vegetables to be irradiated may not move into or through any of the
States listed in this paragraph, except that movement is allowed through
Dallas/Fort Worth, Texas, as an authorized stop for air cargo, or as a
transloading location for shipments that arrive by air but that are
subsequently transloaded into trucks for overland movement from Dallas/
Fort Worth into an authorized State by the shortest route.
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\1\ Irradiation facilities may be located at the maritime ports of
Gulfport, MS, or Wilmington, NC, or the airport of Atlanta, GA, if the
following special conditions are met: The articles to be irradiated must
be imported packaged in accordance with paragraph (g)(2)(i)(A) of this
section; the irradiation facility and APHIS must agree in advance on the
route by which shipments are allowed to move between the vessel on which
they arrive and the irradiation facility; untreated articles may not be
removed from their packaging prior to treatment under any circumstances;
blacklight or sticky paper must be used within the irradiation facility,
and other trapping methods, including Jackson/methyl eugenol and McPhail
traps, must be used within the 4 square miles surrounding the facility;
and the facility must have contingency plans, approved by APHIS, for
safely destroying or disposing of fruit.
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(c) Compliance agreement with importers and facility operators for
irradiation in the United States. If irradiation is conducted in the
United States, both the importer and the operator of the irradiation
facility must sign compliance agreements with the Administrator. In the
facility compliance agreement, the facility operator must agree to
comply with any additional requirements found necessary by the
Administrator to prevent the escape, prior to irradiation, of any fruit
flies that may be associated with the articles to be irradiated. In the
importer compliance agreement, the importer must agree to comply with
any additional requirements found necessary by the Administrator to
ensure the shipment is not diverted to a destination
[[Page 167]]
other than treatment and to prevent escape of plant pests from the
articles to be irradiated during their transit from the port of first
arrival to the irradiation facility in the United States.
(d) Compliance agreement with irradiation facilities outside the
United States. If irradiation is conducted outside the United States,
the operator of the irradiation facility must sign a compliance
agreement with the Administrator and the plant protection service of the
country in which the facility is located. In this agreement, the
facility operator must agree to comply with the requirements of this
section, and the plant protection service of the country in which the
facility is located must agree to monitor that compliance and to inform
the Administrator of any noncompliance.
(e) Certified facility. The irradiation treatment facility must be
certified by the Administrator. Recertification is required in the event
of an increase or decrease in the amount of radioisotope, a major
modification to equipment that affects the delivered dose, or a change
in the owner or managing entity of the facility. Recertification also
may be required in cases where a significant variance in dose delivery
has been measured by the dosimetry system. In order to be certified, a
facility must:
(1) Be capable of administering the minimum absorbed ionizing
radiation doses specified in paragraph (a) of this section to the fruits
and vegetables;\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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(2) Be constructed so as to provide physically separate locations
for treated and untreated fruits and vegetables, except that fruits and
vegetables traveling by conveyor directly into the irradiation chamber
may pass through an area that would otherwise be separated. The
locations must be separated by a permanent physical barrier such as a
wall or chain link fence 6 or more feet high to prevent transfer of
cartons, or some other means approved during certification to prevent
reinfestation of articles and spread of pests;
(3) If the facility is located in the United States, the facility
will only be certified if the Administrator determines that regulated
articles will be safely transported to the facility from the port of
arrival without significant risk that plant pests will escape in transit
or while the regulated articles are at the facility.
(f) Monitoring and interagency agreements. Treatment must be
monitored by an inspector. This monitoring will include inspection of
treatment records and unannounced inspections of the facility by an
inspector, and may include inspection of articles prior to or after
irradiation. Facilities that carry out irradiation operations must
notify the Director of Preclearance, PPQ, APHIS, 4700 River Road Unit
140, Riverdale, MD 20737-1236, of scheduled operations at least 30 days
before operations commence, except where otherwise provided in the
facility preclearance work plan. To ensure the appropriate level of
monitoring, before articles may be imported in accordance with this
section, the following agreements must be signed:
(1) Irradiation treatment framework equivalency work plan. The plant
protection service of a country from which articles are to be imported
into the United States in accordance with this section must sign a
framework equivalency work plan with APHIS. In this plan, both the
foreign plant protection service and APHIS will specify the following
items for their respective countries:
(i) Citations for any requirements that apply to the importation of
irradiated fruits and vegetables;
(ii) The type and amount of inspection, monitoring, or other
activities that will be required in connection with allowing the
importation of irradiated fruits and vegetables into that country; and
(iii) Any other conditions that must be met to allow the importation
of irradiated fruits and vegetables into that country.
(2) Facility preclearance work plan. Prior to commencing importation
into the United States of articles treated at a foreign irradiation
facility, APHIS and the plant protection service of the country from
which articles are to be
[[Page 168]]
imported must jointly develop a preclearance work plan that details the
activities that APHIS and the foreign plant protection service will
carry out in connection with each irradiation facility to verify the
facility's compliance with the requirements of this section. Typical
activities to be described in this work plan may include frequency of
visits to the facility by APHIS and foreign plant protection inspectors,
methods for reviewing facility records, and methods for verifying that
facilities are in compliance with the requirements for separation of
articles, packaging, labeling, and other requirements of this section.
This facility preclearance work plan will be reviewed and renewed by
APHIS and the foreign plant protection service on an annual basis.
(3) Trust fund agreement. Irradiated articles may be imported into
the United States in accordance with this section only if the plant
protection service of the country in which the irradiation facility is
located has entered into a trust fund agreement with APHIS. That
agreement requires the plant protection service to pay, in advance of
each shipping season, all costs that APHIS estimates it will incur in
providing inspection and treatment monitoring services at the
irradiation facility during that shipping season. Those costs include
administrative expenses and all salaries (including overtime and the
Federal share of employee benefits), travel expenses (including per diem
expenses), and other incidental expenses incurred by APHIS in performing
these services. The agreement will describe the general nature and scope
of APHIS services provided at irradiation facilities covered by the
agreement, such as whether APHIS inspectors will monitor operations
continuously or intermittently, and will generally describe the extent
of inspections APHIS will perform on articles prior to and after
irradiation. The agreement requires the plant protection service to
deposit a certified or cashier's check with APHIS for the amount of
those costs, as estimated by APHIS. If the deposit is not sufficient to
meet all costs incurred by APHIS, the agreement further requires the
plant protection service to deposit with APHIS a certified or cashier's
check for the amount of the remaining costs, as determined by APHIS,
before any more articles irradiated in that country may be imported into
the United States. After a final audit at the conclusion of each
shipping season, any overpayment of funds would be returned to the plant
protection service or held on account until needed, at the option of the
plant protection service.
(g) Packaging. Fruits and vegetables that are irradiated in
accordance with this section must be packaged in cartons in the
following manner:
(1) All fruits and vegetables treated with irradiation must be
shipped in the same cartons in which they are treated. Irradiated fruits
and vegetables may not be packaged for shipment in a carton with
nonirradiated fruits and vegetables.
(2) For all fruits and vegetables irradiated prior to arrival in the
United States:
(i) The fruits and vegetables to be irradiated must be packaged
either:
(A) In insect-proof cartons that have no openings that will allow
the entry of fruit flies. The cartons must be sealed with seals that
will visually indicate if the cartons have been opened. The cartons may
be constructed of any material that prevents the entry of fruit flies
and prevents oviposition by fruit flies into the articles in the carton;
\3\ or
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\3\ If there is a question as to the adequacy of a carton, send a
request for approval of the carton, together with a sample carton, to
the Animal and Plant Health Inspection Service, Plant Protection and
Quarantine, Oxford Plant Protection Center, 901 Hillsboro Street,
Oxford, NC 27565.
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(B) In noninsect-proof cartons that are stored immediately after
irradiation in a room completely enclosed by walls or screening that
completely precludes access by fruit flies. If stored in noninsect-proof
cartons in a room that precludes access by fruit flies, prior to leaving
the room each pallet of cartons must be completely enclosed in
polyethylene, shrink-wrap, or another solid or netting covering that
completely precludes access to the cartons by fruit flies.
[[Page 169]]
(ii) To preserve the identity of treated lots, each pallet-load of
cartons containing the fruits and vegetables must be wrapped before
leaving the irradiation facility in one of the following ways:
(A) With polyethylene shrink wrap;
(B) With net wrapping; or
(C) With strapping so that each carton on an outside row of the
pallet load is constrained by a metal or plastic strap.
(iii) Packaging must be labeled with treatment lot numbers, packing
and treatment facility identification and location, and dates of packing
and treatment. Pallets that remain intact as one unit until entry into
the United States may have one such label per pallet. Pallets that are
broken apart into smaller units prior to or during entry into the United
States must have the required label information on each individual
carton.
(h) Dosimetry systems at the irradiation facility. (1) Dosimetry
mapping must indicate the doses needed to ensure that all the commodity
will receive the minimum dose prescribed.
(2) Absorbed dose must be measured using an accurate dosimetry
system that ensures that the absorbed dose meets or exceeds the absorbed
dose required by paragraph (a) of this section (150, 210, 225, 250, or
300 gray, depending on the target species of fruit fly or seed weevil).
(3) When designing the facility's dosimetry system and procedures
for its operation, the facility operator must address guidance and
principles from American Society for Testing and Materials (ASTM)
standards \4\ or an equivalent standard recognized by the Administrator.
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\4\ Designation ISO/ASTM 51261-2002(E) , ``Standard Guide for
Selection and Calibration of Dosimetry Systems for Radiation
Processing,'' American Society for Testing and Materials, Annual Book of
ASTM Standards.
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(i) Records. An irradiation processor must maintain records of each
treated lot for 1 year following the treatment date and must make these
records available for inspection by an inspector during normal business
hours (8 a.m. to 4:30 p.m., Monday through Friday, except holidays).
These records must include the lot identification, scheduled process,
evidence of compliance with the scheduled process, ionizing energy
source, source calibration, dosimetry, dose distribution in the product,
and the date of irradiation.
(j) Request for certification and inspection of facility. Persons
requesting certification of an irradiation treatment facility must
submit the request for approval in writing to the Animal and Plant
Health Inspection Service, Plant Protection and Quarantine, Oxford Plant
Protection Center, 901 Hillsboro Street, Oxford, NC 27565. The initial
request must identify the owner, location, and radiation source of the
facility, and the applicant must supply additional information about the
facility construction, treatment protocols, and operations upon request
by APHIS if APHIS requires additional information to evaluate the
request. Before the Administrator determines whether an irradiation
facility is eligible for certification, an inspector will make a
personal inspection of the facility to determine whether it complies
with the standards of this section.
(k) Denial and withdrawal of certification. (1) The Administrator
will withdraw the certification of any irradiation treatment facility
upon written request from the irradiation processor.
(2) The Administrator will deny or withdraw certification of an
irradiation treatment facility when any provision of this section is not
met. Before withdrawing or denying certification, the Administrator will
inform the irradiation processor in writing of the reasons for the
proposed action and provide the irradiation processor with an
opportunity to respond. The Administrator will give the irradiation
processor an opportunity for a hearing regarding any dispute of a
material fact, in accordance with rules of practice that will be adopted
for the proceeding. However, the Administrator will suspend
certification pending final determination in the proceeding if he or she
determines that suspension is necessary to prevent the spread of any
dangerous insect. The suspension will be effective upon oral or written
notification, whichever is earlier, to the irradiation processor. In the
event of oral notification, written confirmation
[[Page 170]]
will be given to the irradiation processor within 10 days of the oral
notification. The suspension will continue in effect pending completion
of the proceeding and any judicial review of the proceeding.
(l) Department not responsible for damage. This treatment is
approved to assure quarantine security against the listed fruit flies.
From the literature available, the fruits and vegetables authorized for
treatment under this section are believed tolerant to the treatment;
however, the facility operator and shipper are responsible for
determination of tolerance. The Department of Agriculture and its
inspectors assume no responsibility for any loss or damage resulting
from any treatment prescribed or monitored. Additionally, the Nuclear
Regulatory Commission is responsible for ensuring that irradiation
facilities are constructed and operated in a safe manner. Further, the
Food and Drug Administration is responsible for ensuring that irradiated
foods are safe and wholesome for human consumption.
(Approved by the Office of Management and Budget under control number
0579-0155)