[Code of Federal Regulations] [Title 7, Volume 5] [Revised as of January 1, 2003] From the U.S. Government Printing Office via GPO Access [CITE: 7CFR318.13-4f] [Page 178-181] TITLE 7--AGRICULTURE CHAPTER III--ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE PART 318--HAWAIIAN AND TERRITORIAL QUARANTINE NOTICES--Table of Contents Subpart--Hawaiian Fruits and Vegetables 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: Abiu, atemoya, carambola, litchi, longan, papaya, rambutan, and sapodilla. (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 [[Page 179]] 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 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 and longan from Hawaii may not be moved interstate into Florida. All cartons in which litchi or longan are packed must be stamped ``Not for importation into or distribution in FL.'' [[Page 180]] (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 [[Page 181]] 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 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. [62 FR 36974, July 10, 1997, as amended at 63 FR 65648, Nov. 30, 1998]