PART 305—PHYTOSANITARY TREATMENTS Authority: 7 U.S.C. 7701-7772 and 7781-7786; 21 U.S.C. 136 and 136a; 7 CFR 2.22, 2.80, and 371.3. Source: 75 FR 4241, Jan. 26, 2010, unless otherwise noted. § 305.1 Definitions. Administrator. APHIS. Cold treatment. Dose mapping. Dosimeter. Dosimetry system. Fumigant. Fumigation. Inspector. Irradiation. Methyl bromide. Neutralize. Plant Protection and Quarantine (PPQ). PPQ Treatment Manual. https://acir.aphis.usda.gov/s/treatment-hub, Quick freeze. Section 18 of Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Treatment facility. Vacuum fumigation. [75 FR 4241, Jan. 26, 2010, as amended at 76 FR 60360, Sept. 29, 2011; 83 FR 5876, Feb. 12, 2018; 89 FR 79734, Oct. 1, 2024] § 305.2 Approved treatments. (a) Certain commodities or articles require treatment, or are subject to treatment, prior to interstate movement within the United States or importation or entry into the United States. Treatment is required as indicated in parts 301, 318, and 319 of this chapter, on a permit, or by an inspector. (b) Treatments may only be administered in accordance with the requirements of this part and in accordance with treatment schedules approved by the Administrator as effective at neutralizing quarantine pests. The treatment schedules found in the PPQ Treatment Manual have been approved by the Administrator. Treatment schedules may be added to the PPQ Treatment Manual in accordance with § 305.3. Treatment schedules may also be approved by the Administrator in accordance with paragraph (c) of this section. (c) Persons who wish to have a treatment schedule approved by the Administrator as effective at neutralizing a quarantine pest or pests may apply for approval by submitting the treatment schedule, along with any supporting information and data, to the Animal and Plant Health Inspection Service, Plant Protection and Quarantine, Center for Plant Health Science and Technology, 1730 Varsity Drive, Suite 400, Raleigh, NC 27606-5202. Upon receipt of such an application, the Administrator will review the schedule and the supporting information and data and respond with approval or denial of the treatment schedule. If the Administrator determines the treatment schedule to be of potential general use, the Administrator may add the new treatment schedule to the PPQ Treatment Manual or revise an existing schedule, as appropriate, in accordance with § 305.3. (d) APHIS is not responsible for losses or damages incurred during treatment and recommends that a sample be treated first before deciding whether to treat the entire shipment. [75 FR 4241, Jan. 26, 2010, as amended at 76 FR 60360, Sept. 29, 2011] § 305.3 Processes for adding, revising, or removing treatment schedules in the PPQ Treatment Manual. (a) Normal process for adding, revising, or removing treatment schedules. (1) Notice of change to treatment schedule. Federal Register (2) Response to comments. (A) No comments were received on the notice; (B) The comments on the notice supported our action; or (C) The comments on the notice were evaluated but did not change our determination that it is necessary to add, revise, or remove the treatment schedule, as described in the notice. (ii) If the notice issued after the close of the public comment period indicates that a change will be made to the PPQ Treatment Manual, APHIS will make available a new version of the PPQ Treatment Manual that reflects the addition, revision, or removal of the particular treatment schedule. (iii) If comments present information that causes us to determine that the change described in the notice is not appropriate, APHIS will issue a notice informing the public of this determination after the close of the comment period. (b) Process for immediately adding, revising, or removing treatment schedules. (1) Circumstances in which the immediate process may be used. (i) PPQ has determined that an approved treatment schedule is ineffective at neutralizing the targeted plant pest(s); (ii) PPQ has determined that, in order to neutralize the targeted plant pest(s), the treatment schedule must be administered using a different process than was previously used; (iii) PPQ has determined that a new treatment schedule is effective, based on efficacy data, and that ongoing trade in an article or articles may be adversely impacted unless the new treatment schedule is approved for use; or (iv) The use of a treatment schedule is no longer authorized by the U.S. Environmental Protection Agency or by any other Federal entity. (2) Process for immediate change to treatment schedules. Federal Register (3) Response to comments. (A) No comments were received on the notice; (B) The comments on the notice supported our action; or (C) The comments on the notice were evaluated but did not change our determination that it was necessary to add, revise, or remove the treatment schedule, as described in the notice. (ii) If the notice issued after the close of the public comment period indicates that the initial change to the PPQ Treatment Manual is affirmed, APHIS will make available a new version of the PPQ Treatment Manual that will reflect the addition, revision, or removal of the particular treatment schedule in the main body of the PPQ Treatment Manual. (iii) If comments present information that causes us to determine that it is necessary to change a treatment schedule added to the PPQ Treatment Manual under this process or to further revise a treatment schedule that was revised under this process, APHIS will publish a notice in the Federal Register (iv) If comments present information that causes us to determine that the change described in the initial notice was not appropriate, APHIS will publish a notice in the Federal Register § 305.4 Monitoring and certification of treatments. (a) All treatments approved under part 305 are subject to monitoring and verification by APHIS. (b) Any treatment performed outside the United States must be monitored and certified by an inspector or an official authorized by APHIS. During the entire interval between treatment and export, the consignment must be stored and handled in a manner that prevents any infestation by pests and noxious weeds. § 305.5 Chemical treatment requirements. (a) Certified facility. (1) Be capable of administering the required dosage range for the required duration and at the appropriate temperature, as specified in the treatment schedules in the PPQ Treatment Manual or in another treatment schedule approved in accordance with § 305.2. (2) Be adequate to contain the fumigant and be constructed from material that is not reactive to the fumigant. (3) For vacuum fumigation facilities, be constructed to withstand required negative pressure. (b) Monitoring. (c) Compliance agreements. (1) Fumigation treatment facilities treating imported articles; compliance agreements with facility operators for fumigation in the United States. (2) Fumigation treatment facilities treating articles moved interstate from Hawaii and U.S. territories. (3) Fumigation treatment facilities treating articles moved interstate from areas quarantined for fruit flies. (4) Fumigation treatment facilities treating articles moved interstate from areas quarantined for Asian citrus psyllid. (d) Treatment procedures. (2) Temperature/concentration readings must be taken for items known to be sorptive or whose sorptive properties are unknown when treatment is administered in chambers at normal atmospheric pressure. (3) Unless otherwise specified in the PPQ Treatment Manual or in another approved treatment schedule, the volume of the commodity stacked inside the treatment enclosure must not exceed 2/3 (4) Recording and measuring equipment must be adequate to accurately monitor the gas concentration, to ensure the correct amount of gas reaches the pests, and to detect any leaks in the enclosure. At least three sampling tubes or monitoring lines must be used in the treatment enclosure. (5) An adequate number of blowers or fans must be used inside of the treatment enclosure to uniformly distribute gas throughout the enclosure. The circulation system must be able to recirculate the entire volume of gas in the enclosure in 3 minutes or less. (6) The exposure period begins after all gas has been introduced. (7) For vacuum fumigation: The vacuum pump must be able to reduce pressure in the treatment enclosure to 1-2 inches of mercury in 15 minutes or less. (Approved by the Office of Management and Budget under control number 0579-0450) [75 FR 4241, Jan. 26, 2010, as amended at 76 FR 60361, Sept. 29, 2011; 83 FR 5876, Feb. 12, 2018] § 305.6 Cold treatment requirements. (a) Certification of treatment facilities. (1) Be capable of keeping treated and untreated fruits, vegetables, or other articles separate so as to prevent reinfestation of articles and spread of pests; (2) Be capable of preventing the escape and spread of pests while regulated articles are at the facility; and (3) Have equipment that is adequate to effectively perform cold treatment. (b)(1) Location of facilities. (i) Prospective facility operators must submit a detailed layout of the facility site and its location to APHIS. APHIS will evaluate plant health risks based on the proposed location and layout of the facility site. APHIS will only approve a proposed facility if the Administrator determines that regulated articles can be safely transported to the facility from the port of entry or points of origin in the United States. (ii) The government of the State in which the facility is to be located must concur in writing with the location of the facility or, if it does not concur, must provide a written explanation of concern based on pest risks. In instances where the State government does not concur with the proposed facility location, and provides a written explanation of concern based on pest risks, APHIS and the State must agree on a strategy to resolve the pest risk concerns prior to APHIS approval. If the State does not provide a written explanation of concern based on pest risks, then State concurrence will not be required before APHIS approves the facility location. (iii) Untreated articles may not be removed from their packaging prior to treatment under any circumstances. (iv) The facility must have contingency plans, approved by APHIS, for safely destroying or disposing of regulated articles if the facility is unable to properly treat a shipment. (v) The facility may only treat articles approved by APHIS for treatment at the facility. Approved articles will be listed in the compliance agreement required in paragraph (f) of this section. (vi) Arrangements for treatment must be made before the departure of a consignment from its port of entry or points of origin in the United States. APHIS and the facility must agree on all parameters, such as time, routing, and conveyance, by which the consignment will move from the port of entry or points of origin in the United States to the treatment facility. If APHIS and the facility cannot reach agreement in advance on these parameters then no consignments may be moved to that facility until an agreement has been reached. (vii) Regulated articles must be conveyed to the facility in a refrigerated (via motorized refrigeration equipment) conveyance at a temperature that minimizes the mobility of the pests of concern for the article. (viii) The facility must apply all post-treatment safeguards required for certification under paragraph (a) of this section before releasing the articles. (ix) The facility must remain locked when not in operation. (x) The facility must maintain and provide APHIS with an updated map identifying places where horticultural or other crops are grown within 4 square miles of the facility. Proximity of host material to the facility will necessitate trapping or other pest monitoring activities, funded by the facility, to help prevent establishment of any escaped pests of concern, as approved by APHIS; these activities will be listed in the compliance agreement required in paragraph (f) of this section. The treatment facility must have a pest management plan within the facility. (xi) The facility must comply with any additional requirements including, but not limited to, the use of pest-proof packaging and container seals, that APHIS may require to prevent the escape of plant pests during transport to and from the cold treatment facility itself, for a particular facility based on local conditions, and for any other risk factors of concern. These activities will be listed in the compliance agreement required in paragraph (f) of this section. (2) For articles that are moved interstate from areas quarantined for fruit flies, cold treatment facilities may be located either within or outside of the quarantined area. If the articles are treated outside the quarantined area, they must be accompanied to the facility by a limited permit issued in accordance with § 301.32-5(b) of this chapter and must be moved in accordance with any safeguards determined to be appropriate by APHIS. (c) Cold treatment enclosures. (1) Be capable of maintaining the highest temperature of the treatment schedule under which the fruit will be treated specified in the PPQ Treatment Manual or in another approved treatment schedule before the treatment begins and holding fruit at or below the treatment temperature during the treatment. (2) Maintain fruit pulp temperatures according to treatment schedules with no more than a 0.39 °C (0.7 °F) variation in temperature between two consecutive hourly readings. (3) Be structurally sound and adequate to maintain required temperatures. (d) Treatment procedures. (2) Refrigeration must be completed in the container, compartment, or room in which it is begun. (3) Fruit that may be cold treated must be safeguarded to prevent cross-contamination or mixing with other infested fruit. (4) Fruit intended for in-transit cold treatment must be precooled to no more than the highest temperature of the treatment schedule under which the fruit will be treated prior to beginning treatment. The in-transit treatment enclosure may not be used for precooling unless an official authorized by APHIS approves the loading of the fruit in the treatment enclosure as adequate to allow for fruit pulp temperatures to be taken prior to beginning treatment. If the fruit is precooled outside the treatment enclosure, an official authorized by APHIS will take pulp temperatures manually from a sample of the fruit as the fruit is loaded for in-transit cold treatment to verify that precooling was completed. If the pulp temperatures for the sample are 0.28 °C (0.5 °F) or more above the highest temperature of the treatment schedule under which the fruit will be treated, the pallet from which the sample was taken will be rejected and returned for additional precooling until the fruit reaches the highest temperature of the treatment schedule under which the fruit will be treated. If fruit is precooled in the treatment enclosure, or if treatment is conducted at a cold treatment facility in the United States, the fruit must be precooled to the highest temperature of the treatment schedule under which the fruit will be treated, as verified by an official authorized by APHIS, prior to beginning treatment. (5) Breaks, damage, etc., in the treatment enclosure that preclude maintaining correct temperatures must be repaired before the enclosure is used. An official authorized by APHIS must approve loading of compartment, number and placement of temperature probes or sensors, and initial fruit temperature readings before beginning the treatment. Hanging decks and hatch coamings within vessels may not be used as enclosures for in-transit cold treatment without prior written approval from APHIS. Double-stacking of pallets is not allowed. (6) Only the same type of fruit in the same type of package may be treated together in a container; no mixture of fruits in containers may be treated. A numbered seal must be placed on the doors of the loaded container and may be removed only at the port of destination by an official authorized by APHIS. (7) Temperature recording devices used during treatment must be secured using measures approved by APHIS as adequate to ensure the security and integrity of cold treatment data. The devices must be able to record the date, time, and sensor number and automatic and continuous records of the temperature during all calibrations and during treatment. Recording devices must be capable of generating temperature charts for verification by an inspector. If records of calibrations or treatments are found to have been manipulated, the vessel or container in which the treatment is performed may be suspended from conducting cold treatments until proper equipment is installed and an official authorized by APHIS has recertified it. APHIS' decision to recertify a vessel or container will take into account the severity of the infraction that led to suspension. (8) A minimum of four temperature probes or sensors is required for vessel holds used as treatment enclosures. A minimum of three temperature probes or sensors is required for other treatment enclosures. An official authorized by APHIS will have the option to require that additional temperature probes or sensors be used, depending on the size of the treatment enclosure. (9) Fruit pulp temperatures must be maintained at the temperature specified in the treatment schedule with no more than a 0.39 °C (0.7 °F) variation in temperature between two consecutive hourly readings. Failure to comply with this requirement will result in invalidation of the treatment unless an official authorized by APHIS can verify that the pulp temperature was maintained at or below the treatment temperature for the duration of the treatment. (10) The time required to complete the treatment begins when all temperature probes reach the prescribed cold treatment schedule temperature. Refrigeration continues until the vessel arrives at the port of destination and the fruit is released for unloading by an inspector even though this may prolong the period required for the cold treatment. (11) Temperatures must be recorded at intervals no longer than 1 hour apart. Gaps of longer than 1 hour will invalidate the treatment or indicate treatment failure unless an official authorized by APHIS can verify that the pulp temperature was maintained at or below the treatment temperature for the duration of the treatment. (12) Cold treatment is not completed until so declared by an official authorized by APHIS or the certifying official of the foreign country; consignments of treated commodities may not be discharged until APHIS clearance has been fully completed, including review and approval of treatment record charts. (13) Cold treatment of fruits in break bulk vessels or containers must be initiated by an official authorized by APHIS if there is not a treatment technician who has been trained to initiate cold treatments for either break bulk vessels or containers. (14) An official authorized by APHIS may perform audits to ensure that the treatment procedures comply with the regulations in this section and that the treatment is administered in accordance with the treatment schedules in the PPQ Treatment Manual or in accordance with another approved treatment schedule. The official authorized by APHIS must be given the appropriate materials and access to the facility, container, or vessel necessary to perform the audits. (15) An inspector will sample and cut fruit from each consignment after it has been cold treated to monitor treatment effectiveness. If a single live pest of concern in any stage of development is found, the consignment will be held until an investigation is completed and appropriate remedial actions have been implemented. If APHIS determines at any time that the safeguards contained in this section do not appear to be effective against the pests of concern, APHIS may suspend the importation of fruits from the originating country and conduct an investigation into the cause of the deficiency. APHIS may waive the sampling and cutting requirement of paragraph (d)(15) of this section, provided that the national plant protection organization (NPPO) of the exporting country has conducted such sampling and cutting in the exporting country as part of a biometric sampling protocol approved by APHIS. (16) The cold treatments required for the entry of fruit are considered necessary for the elimination of plant pests, and no liability shall attach to the U.S. Department of Agriculture or to any officer or representative of that Department in the event injury results to fruit offered for entry in accordance with these instructions. In prescribing cold treatments of certain fruits, it should be emphasized that inexactness and carelessness in applying the treatments may result in injury to the fruit or its rejection for entry. (e) Monitoring. (f) Compliance agreements. (1) Compliance agreements with importers and facility operators for cold treatment in the United States. (2) Compliance agreements with cold treatment facilities outside the United States. (3) Cold treatment facilities treating articles moved interstate from Hawaii and U.S. territories. (Approved by the Office of Management and Budget under control number 0579-0450) [75 FR 4241, Jan. 26, 2010, as amended at 75 FR 52217, Aug. 25, 2010; 76 FR 60361, Sept. 29, 2011; 78 FR 63374, Oct. 24, 2013; 83 FR 5876, Feb. 12, 2018] § 305.7 Quick freeze treatment requirements. Quick freeze treatment for fruits and vegetables imported into the United States or moved interstate from Hawaii or Puerto Rico must be conducted in accordance with §§ 319.56-12 or 318.13-13, respectively, of this chapter. The PPQ Treatment Manual indicates fruits and vegetables for which quick freeze is an authorized treatment. Requests to authorize quick freeze as a treatment for other fruits and vegetables may be made in accordance with § 305.2(c). [75 FR 4241, Jan. 26, 2010, as amended at 76 FR 60361, Sept. 29, 2011] § 305.8 Heat treatment requirements. (a) Certified facility. (1) Have equipment that is capable of adequately circulating air or water (as relevant to the treatment), changing the temperature, and maintaining the changed temperature sufficient to meet the treatment schedule parameters in the PPQ Treatment Manual or in another treatment schedule approved in accordance with § 305.2. (2) Have equipment used to record, monitor, or sense temperature, maintained in proper working order. (3) Keep treated and untreated fruits, vegetables, or articles separate so as to prevent reinfestation and spread of pests. (b) Monitoring. (c) Compliance agreements. (d) Workplans. (e) Treatment procedures. (2) Sensor equipment must be adequate to monitor the treatment, its type and placement must be approved by an official authorized by APHIS, and the equipment must be tested by an official authorized by APHIS prior to beginning the treatment. Sensor equipment must be locked before each treatment to prevent tampering. (3) Fruits, vegetables, or articles of substantially different sizes must be treated separately; oversized fruit may be rejected by an official authorized by APHIS. (4) The treatment period begins when the temperature specified by the treatment schedule has been reached. An official authorized by APHIS may abort the treatment if the facility requires an unreasonably long time to achieve the required temperature. [75 FR 4241, Jan. 26, 2010, as amended at 76 FR 60361, Sept. 29, 2011] § 305.9 Irradiation treatment requirements. Irradiation, carried out in accordance with the provisions of this section, is approved as a treatment for any imported regulated article (i.e., fruits, vegetables, cut flowers, and foliage); for any regulated article moved interstate from Hawaii, Puerto Rico, the U.S. Virgin Islands, Guam, and the Commonwealth of the Northern Marianas Islands (referred to collectively, in this section, as Hawaii and U.S. territories); for any berry, fruit, nut, or vegetable listed as a regulated article in § 301.32-2(a) of this chapter; and for any regulated article listed in 301.76-2 of this chapter and intended for consumption, as apparel or as a similar personal accessory, or for decorative use. (a) Location of facilities. (i) Prospective facility operators must submit a detailed layout of the facility site and its location to APHIS. APHIS will evaluate plant health risks based on the proposed location and layout of the facility site. APHIS will only approve a proposed facility if the Administrator determines that regulated articles can be safely transported to the facility from port of entry or points of origin in the United States. (ii) The government of the State in which the facility is to be located must concur in writing with the location of the facility or, if it does not concur, must provide a written explanation of concern based on pest risks. In instances where the State government does not concur with the proposed facility location, and provides a written explanation of concern based on pest risks, APHIS and the State must agree on a strategy to resolve the pest risk concerns prior to APHIS approval. If the State does not provide a written explanation of concern based on pest risks, then State concurrence will not be required before APHIS approves the facility location. (iii) Untreated articles may not be removed from their packaging prior to treatment under any circumstances. (iv) The facility must have contingency plans, approved by APHIS, for safely destroying or disposing of regulated articles if the facility is unable to properly treat a shipment. (v) The facility may only treat articles approved by APHIS for treatment at the facility. Approved articles will be listed in the compliance agreement required in paragraph (c)(1)(i) of this section. (vi) Arrangements for treatment must be made before the departure of a consignment from its port of entry or points of origin in the United States. APHIS and the facility must agree on all parameters, such as time, routing, and conveyance, by which the consignment will move from the port of entry or points of origin in the United States to the treatment facility. If APHIS and the facility cannot reach agreement in advance on these parameters then no consignments may be moved to that facility until an agreement has been reached. (vii) Regulated articles must be conveyed to the facility in a refrigerated (via motorized refrigeration equipment or other methods including ice or insulation) or air-conditioned conveyance at a temperature that minimizes the mobility of the pests of concern for the article. (viii) The facility must maintain and provide APHIS with an updated map identifying places where horticultural or other crops are grown within 4 square miles of the facility. Proximity of host material to the facility will necessitate trapping or other pest monitoring activities to help prevent establishment of any escaped pests of concern, as approved by APHIS; these activities will be listed in the compliance agreement required in paragraph (c)(1)(i) of this section. The treatment facility must have a pest management plan within the facility. (ix) The facility must comply with any additional requirements that APHIS may require to prevent the escape of plant pests during transport to and from the irradiation facility itself, for a particular facility based on local conditions, and for any other risk factors of concern. These activities will be listed in the compliance agreement required in paragraph (c)(1)(i) of this section. (2) For articles that are moved interstate from areas quarantined for fruit flies, irradiation facilities may be located either within or outside of the quarantined area. If the articles are treated outside the quarantined area, they must be accompanied to the facility by a limited permit issued in accordance with § 301.32-5(b) of this chapter and must be moved in accordance with any safeguards determined to be appropriate by APHIS. (3) For articles that are moved interstate from areas quarantined only for Asian citrus psyllid, and not for citrus greening, irradiation facilities must be located within an area that is not quarantined for citrus greening. (b) Approved facilities. (c) Compliance agreements. Irradiation facilities treating imported articles. Compliance agreements with importers and facility operators for irradiation in the United States. (ii) Compliance agreement with irradiation facilities outside the United States. (2) Irradiation facilities treating articles moved interstate from Hawaii and U.S. territories. (3) Irradiation facilities treating articles moved interstate from areas quarantined for fruit flies. (4) Irradiation facilities treating articles moved interstate from areas quarantined only for Asian citrus psyllid, and not for citrus greening, must complete a compliance agreement with APHIS as provided in § 301.76-8 of this chapter. (d) Certified facility. (1) Be capable of administering the minimum absorbed ionizing radiation doses specified in the PPQ Treatment Manual or in another treatment schedule approved in accordance with § 305.2 to the regulated articles; 1 1 (2) Be constructed so as to provide physically separate locations for treated and untreated articles, except that articles 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 to be used to treat imported articles and is located in the United States, the facility will only be certified if APHIS 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. (e) Monitoring and interagency agreements. (1) Irradiation facilities treating imported articles; irradiation treatment framework equivalency workplan. (A) Citations for any requirements that apply to the importation of irradiated fruits and vegetables; (B) 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 (C) Any other conditions that must be met to allow the importation of irradiated fruits and vegetables into that country. (2) Irradiation facilities located in foreign countries. (i) Facility preclearance workplan. (ii) Trust fund agreement. (3) Irradiation facilities located within the United States. 2 2 (f) Packaging. (1) Irradiated articles may not be packaged for shipment in a carton with nonirradiated articles. (2) For all imported articles irradiated prior to arrival in the United States, all articles moved interstate from Hawaii or U.S. territories and irradiated prior to arrival in the mainland United States, and all regulated articles to be moved interstate from an area quarantined for fruit flies or Asian citrus psyllid that are treated within the quarantined area: (i) The fruits and vegetables must be packaged either: (A) In insect-proof cartons that have no openings that will allow the entry of the pests of concern. 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 entry or oviposition (if applicable) by the pests of concern into the articles in the carton; 3 3 (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 the pests of concern. If stored in noninsect-proof cartons in a room that precludes access by the pests of concern, 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 the pests of concern. (ii) To preserve the integrity of treated lots, each pallet-load of cartons containing the fruits and vegetables must be secured before leaving the irradiation facility in one of the following ways: (A) With polyethylene shrink wrap; (B) With net wrapping; or (C) With strapping. (iii) Packaging must be labeled in a manner that allows an inspector to determine treatment lot numbers, packing and treatment facility identification and location, and dates of packing and treatment. (A) For imported articles that are treated prior to arrival in the United States, 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, or that will be broken apart into smaller units after entry into the United States, must have the required label information on each individual carton. (B) For articles moved interstate from Hawaii or U.S. territories that are treated prior to arrival in the mainland United States, pallets that remain intact as one unit until entry into the mainland United States may have one such label per pallet. Pallets that are broken apart into smaller units prior to or during entry into the mainland United States, or that will be broken apart into smaller units after entry into the mainland United States, must have the required label information on each individual carton. (3) For all articles imported to be irradiated upon arrival in the United States, moved interstate from Hawaii or U.S. territories to be irradiated upon arrival in the mainland United States, or moved interstate from areas quarantined for fruit flies or Asian citrus psyllid to be irradiated outside the quarantined area, the articles must be packed in cartons that have no openings that will allow the exit of the pests of concern and that are sealed with seals that will visually indicate if the cartons have been opened. They may be constructed of any material that prevents the pests of concern from exiting the carton. Cartons of untreated articles must be shipped in shipping containers sealed prior to their shipment with seals that will visually indicate if the shipping containers have been opened. (g) Containers or vans. (h) Certification of treatment for articles treated outside the United States. (i) Dosage. (j) Dosimetry systems at the irradiation facility. (2) The absorbed dose, as measured using an accurate dosimetry system, must meet or exceed the absorbed dose for the pest(s) of concern required by the PPQ Treatment Manual or by another approved treatment schedule. (3) When designing the facility's dosimetry system and procedures for its operation, the facility operator must address guidance and principles from the International Standards Organization/American Society for Testing and Materials standard 4 4 Annual Book of ASTM Standards. (k) Records. (l) Request for initial certification and inspection of facility. (m) Denial and withdrawal of certification. (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 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. (n) Department not responsible for damage. (o) Substitution of irradiation for other treatments. (Approved by the Office of Management and Budget under control numbers 0579-0155, 0579-0215, and 0579-0198, 0579-0383) [75 FR 4241, Jan. 26, 2010, as amended at 75 FR 34336, June 17, 2010; 76 FR 60361, Sept. 29, 2011; 77 FR 42624, July 20, 2012; 83 FR 5878, Feb. 12, 2018]