Phytosanitary Treatments (7 CFR 305.1-305-9)

170 7 CFR Ch. III (1–1–17 Edition) Pt. 302 approved PCR or other molecular test must be conducted, as provided in para graph (b)(1) of this section. (1) PCR or other molecular tests—(i) Negative results. If the results of PCR or other molecular tests are negative for all samples in a nursery, no further testing is required. The nursery may be considered free of evidence of Phytophthora ramorum and plants in the nursery are eligible for interstate movement under certificate in accord ance with § 301.92–5. (ii) Positive results. If any samples tested using PCR or other molecular tests return positive results for Phytophthora ramorum, the nursery from which they originate is prohibited from moving plants interstate. The nursery will be eligible to ship certain plants interstate when an inspector de termines that those plants are free of evidence of Phytophthora ramorum. (2) Culture Test—(i) Negative results. If the results of culture tests are other than positive for any samples taken from a single nursery, plants in the nursery must continue to be withheld from shipment in accordance with § 301.92–11 and each plant sample must be tested again using a PCR or other molecular test, as described in this sec tion. (ii) Positive results. If any culture tests return positive results for Phytophthora ramorum, the nursery from which they originate is prohibited from moving plants interstate as di rected by an inspector. The nursery will be eligible to ship certain plants interstate when an inspector deter mines that those plants are free of evi dence of Phytophthora ramorum. (c) Other test methods. Other test methods may be acceptable if approved by APHIS. PART 302—DISTRICT OF COLUMBIA; MOVEMENT OF PLANTS AND PLANT PRODUCTS Sec. 302.1 Definitions. 302.2 Movement of plants and plant prod ucts. AUTHORITY: 7 U.S.C. 7701–7772 and 7781–7786; 7 CFR 2.22, 2.80, and 371.3. SOURCE: 66 FR 1016, Jan. 5, 2001, unless oth erwise noted. § 302.1 Definitions. Inspector. Any employee of the Ani mal and Plant Health Inspection Serv ice or other person authorized by the Administrator to inspect and certify the plant health status of plants and products under this part. Interstate. From any State into or through any other State. State. The District of Columbia, Puer to Rico, the Northern Mariana Islands, or any State, territory, or possession of the United States. § 302.2 Movement of plants and plant products. Inspection or documentation of the plant health status of plants or plant products to be moved interstate from the District of Columbia may be ob tained by contacting the State Plant Health Director, Plant Protection and Quarantine, APHIS, Wayne A. Cawley, Jr. Building, Room 350, 50 Harry S. Truman Parkway, Annapolis, MD 21401–7080; phone: (410) 224–3452; fax: (410) 224–1142. [66 FR 54641, Oct. 30, 2001] PART 305—PHYTOSANITARY TREATMENTS Sec. 305.1 Definitions. 305.2 Approved treatments. 305.3 Processes for adding, revising, or re moving treatment schedules in the PPQ Treatment Manual. 305.4 Monitoring and certification of treat ments. 305.5 Chemical treatment requirements. 305.6 Cold treatment requirements. 305.7 Quick freeze treatment requirements. 305.8 Heat treatment requirements. 305.9 Irradiation treatment requirements. 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. The Administrator, Animal and Plant Health Inspection Service, United States Department of Agriculture, or any person delegated to act for the Administrator in matters affecting this part. VerDate Sep<11>2014 11:19 Mar 20, 2017 Jkt 241016 PO 00000 Frm 00180 Fmt 8010 Sfmt 8010 Y:\SGML\241016.XXX 241016pm a n g ru m o n D S K 4 S P T V N 1 P R O D w ith C F R 171 Animal and Plant Health Inspection Service, USDA § 305.2 APHIS. The Animal and Plant Health Inspection Service, United States De partment of Agriculture. Cold treatment. Exposure of a com modity to a specified cold temperature that is sustained for a specific time pe riod to kill targeted pests, especially fruit flies. Dose mapping. Measurement of ab sorbed dose within a process load using dosimeters placed at specified loca tions to produce a one-, two-, or three dimensional distribution of absorbed dose, thus rendering a map of absorbed dose values. Dosimeter. A device that, when irradi ated, exhibits a quantifiable change in some property of the device that can be related to absorbed dose in a given ma terial using appropriate analytical in strumentation and techniques. Dosimetry system. A system used for determining absorbed dose, consisting of dosimeters, measurement instru ments and their associated reference standards, and procedures for the sys tem’s use. Fumigant. A gaseous chemical that easily diffuses and disperses in air and is toxic to the target organism. Fumigation. Releasing and dispersing a toxic chemical in the air so that it reaches the target organism in a gas eous state. Inspector. Any individual authorized by the Administrator of APHIS or the Commissioner of Customs and Border Protection, Department of Homeland Security, to enforce the regulations in this part. Irradiation. Treatment with any type of ionizing radiation. Methyl bromide. A colorless, odorless biocide used to fumigate a wide range of commodities. Neutralize. To prevent the establish ment of a plant pest by killing it, steri lizing it, preventing its development from an immature stage, or preventing its emergence from its host. Plant Protection and Quarantine (PPQ). The Plant Protection and Quar antine program of APHIS. PPQ Treatment Manual. A document that contains treatment schedules that are approved by the Administrator for use under this part. The Treatment Manual is available on the Internet at (http://www.aphis.usda.gov/ importlexport/plants/manuals/ index.shtml) or by contacting the Ani mal and Plant Health Inspection Serv ice, Plant Protection and Quarantine, Manuals Unit, 92 Thomas Johnson Drive, Suite 200, Frederick, MD 21702. Quick freeze. A commercially accept able method of quick freezing at sub zero temperatures with subsequent storage and transportation at not high er than 20 °F. Methods that accomplish this are known as quick freezing, sharp freezing, cold pack, or frozen pack, but may be any equivalent commercially acceptable freezing method. Section 18 of Federal Insecticide, Fun gicide, and Rodenticide Act (FIFRA). An emergency exemption granted by the U.S. Environmental Protection Agency to Federal or State agencies author izing an unregistered use of a pesticide for a limited time. Vacuum fumigation. Fumigation per formed in a gas-tight enclosure. Most air in the enclosure is removed and re placed with a small amount of fumi gant. The reduction in pressure reduces the required duration of the treatment. [75 FR 4241, Jan. 26, 2010, as amended at 76 FR 60360, Sept. 29, 2011] § 305.2 Approved treatments. (a) Certain commodities or articles require treatment, or are subject to treatment, prior to interstate move ment within the United States or im portation or entry into the United States. Treatment is required as indi cated in parts 301, 318, and 319 of this chapter, on a permit, or by an inspec tor. (b) Treatments may only be adminis tered in accordance with the require ments of this part and in accordance with treatment schedules approved by the Administrator as effective at neu tralizing quarantine pests. The treat ment 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 treat ment schedule approved by the Admin istrator as effective at neutralizing a VerDate Sep<11>2014 11:19 Mar 20, 2017 Jkt 241016 PO 00000 Frm 00181 Fmt 8010 Sfmt 8010 Y:\SGML\241016.XXX 241016pm a n g ru m o n D S K 4 S P T V N 1 P R O D w ith C F R 172 7 CFR Ch. III (1–1–17 Edition) § 305.3 quarantine pest or pests may apply for approval by submitting the treatment schedule, along with any supporting in formation 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 re view the schedule and the supporting information and data and respond with approval or denial of the treatment schedule. If the Administrator deter mines the treatment schedule to be of potential general use, the Adminis trator may add the new treatment schedule to the PPQ Treatment Man ual 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 sam ple 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. Unless there is a need to immediately add, re vise, or remove a treatment schedule, as provided in paragraph (b)(1) of this section, a treatment schedule may be added to the PPQ Treatment Manual, revised, or removed from the PPQ Treatment Manual as follows: (1) Notice of change to treatment sched ule. APHIS will publish in the FEDERAL REGISTER a notice describing the rea sons we have determined that it is nec essary to add, revise, or remove a treatment schedule and, if necessary, making available the new or revised treatment schedule as it would be added to the PPQ Treatment Manual. In our notice, we will provide for a pub lic comment period on the new or re vised treatment schedule or on the re moval of the treatment schedule from the PPQ Treatment Manual. (2) Response to comments. (i) APHIS will issue a notice after the close of the public comment period indicating that the treatment schedule specified in the initial notice will be added to the PPQ Treatment Manual, revised as de scribed in the notice, or removed from the PPQ Treatment Manual if: (A) No comments were received on the notice; (B) The comments on the notice sup ported our action; or (C) The comments on the notice were evaluated but did not change our deter mination that it is necessary to add, revise, or remove the treatment sched ule, 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 ad dition, revision, or removal of the par ticular 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 determina tion after the close of the comment pe riod. (b) Process for immediately adding, re vising, or removing treatment schedules. Treatment schedules may be imme diately added to the PPQ Treatment Manual, revised, or removed from the PPQ Treatment Manual under the cir cumstances described in paragraph (b)(1) of this section and in accordance with the process described in para graphs (b)(2) and (b)(3) of this section. (1) Circumstances in which the imme diate process may be used. Treatment schedules may be immediately added to the PPQ Treatment Manual, revised, or removed from the PPQ Treatment Manual if any of the following cir cumstances apply: (i) PPQ has determined that an ap proved treatment schedule is ineffec tive 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 VerDate Sep<11>2014 11:19 Mar 20, 2017 Jkt 241016 PO 00000 Frm 00182 Fmt 8010 Sfmt 8010 Y:\SGML\241016.XXX 241016pm a n g ru m o n D S K 4 S P T V N 1 P R O D w ith C F R 173 Animal and Plant Health Inspection Service, USDA § 305.5 treatment schedule is approved for use; or (iv) The use of a treatment schedule is no longer authorized by the U.S. En vironmental Protection Agency or by any other Federal entity. (2) Process for immediate change to treatment schedules. If PPQ determines that one or more of the circumstances in paragraph (b)(1) of this section ap plies and that it is necessary to take immediate action, APHIS will publish in the FEDERAL REGISTER a notice de scribing the reasons we have deter mined that it is necessary to imme diately add, revise, or remove a treat ment schedule and, if necessary, mak ing available the new or revised treat ment schedule as it has been added to the PPQ Treatment Manual. Treat ment schedules that have been added to the PPQ Treatment Manual or re vised under this process will be identi fied in the PPQ Treatment Manual as having been added or revised through the immediate process described in this paragraph (b). The PPQ Treatment Manual will indicate that these treat ment schedules are subject to change or removal based on public comment. In our notice, we will provide for a pub lic comment period on the new or re vised treatment schedule or on the re moval of the treatment schedule from the PPQ Treatment Manual. (3) Response to comments. (i) APHIS will issue a notice after the close of the public comment period affirming the action described in the initial notice if: (A) No comments were received on the notice; (B) The comments on the notice sup ported our action; or (C) The comments on the notice were evaluated but did not change our deter mination that it was necessary to add, revise, or remove the treatment sched ule, 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 re moval 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 sched ule added to the PPQ Treatment Man ual under this process or to further re vise a treatment schedule that was re vised under this process, APHIS will publish a notice in the FEDERAL REG ISTER informing the public of this de termination after the close of the com ment period and will revise the treat ment schedule accordingly. (iv) If comments present information that causes us to determine that the change described in the initial notice was not appropriate, APHIS will pub lish a notice in the FEDERAL REGISTER informing the public of this determina tion after the close of the comment pe riod and will, if necessary, remove the new or revised treatment schedule from the separate section of the PPQ Treatment Manual. § 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 offi cial 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 require ments. (a) Certified facility. The fumigation treatment facility must be certified by APHIS. Facilities are required to be in spected and recertified annually, or as often as APHIS directs, depending upon treatments performed, commodities handled, and operations conducted at the facility. In order to be certified, a fumigation facility must: (1) Be capable of administering the required dosage range for the required duration and at the appropriate tem perature, as specified in the treatment schedules in the PPQ Treatment Man ual or in another treatment schedule approved in accordance with § 305.2. VerDate Sep<11>2014 11:19 Mar 20, 2017 Jkt 241016 PO 00000 Frm 00183 Fmt 8010 Sfmt 8010 Y:\SGML\241016.XXX 241016pm a n g ru m o n D S K 4 S P T V N 1 P R O D w ith C F R 174 7 CFR Ch. III (1–1–17 Edition) § 305.6 (2) Be adequate to contain the fumi gant 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. Treatment must be monitored by an official authorized by APHIS to ensure proper administration of the treatment, including that the correct amount of gas reaches the tar get organism and that an adequate number and placement of blowers, fans, sampling tubes, or monitoring lines are used in the treatment enclosure. An of ficial authorized by APHIS approves, adjusts, or rejects the treatment. (c) Treatment procedures. (1) To kill the pest, all chemical applications must be administered in accordance with an Environmental Protection Agency (EPA) approved pesticide label and the APHIS-approved treatment schedule prescribed in the PPQ Treat ment Manual or in another treatment schedule approved in accordance with § 305.2. If EPA cancels approval for the use of a pesticide on a commodity, then the treatment schedule prescribed in the PPQ Treatment Manual or ap proved in accordance with § 305.2 is no longer authorized for that commodity. If the commodity is not listed on the pesticide label and/or included in a Federal quarantine or crisis exemption in accordance with FIFRA section 18, then no chemical treatment is avail able. (2) Temperature/concentration read ings must be taken for items known to be sorptive or whose sorptive prop erties 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 vol ume of the commodity stacked inside the treatment enclosure must not ex ceed 2⁄3 of the volume of the enclosure. Stacking must be approved by an offi cial authorized by APHIS before treat ment begins. All commodities under going treatment must be listed on the label or authorized under Section 18 of FIFRA. (4) Recording and measuring equip ment must be adequate to accurately monitor the gas concentration, to en sure 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 treat ment enclosure to uniformly distribute gas throughout the enclosure. The cir culation system must be able to recir culate 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 vac uum pump must be able to reduce pres sure in the treatment enclosure to 1-2 inches of mercury in 15 minutes or less. [75 FR 4241, Jan. 26, 2010, as amended at 76 FR 60361, Sept. 29, 2011] § 305.6 Cold treatment requirements. (a) Certification of treatment facilities. All facilities or locations used for re frigerating fruits or vegetables in ac cordance with the cold treatment schedules in the PPQ Treatment Man ual or in another treatment schedule approved in accordance with § 305.2 must be certified by APHIS. Recertifi cation of the facility or carrier is re quired every 3 years, or as often as APHIS directs, depending on treat ments performed, commodities han dled, and operations conducted at the facility. In order to be certified, facili ties and carriers must: (1) Be capable of keeping treated and untreated fruits, vegetables, or other articles separate so as to prevent re infestation of articles and spread of pests; (2) Have equipment that is adequate to effectively perform cold treatment. (b) Places of treatment; ports of entry. Precooling and refrigeration may be performed prior to, or upon arrival of fruits and vegetables in the United States, provided treatments are per formed in accordance with applicable requirements of this section. Fruits and vegetables that are not treated prior to arrival in the United States must be treated after arrival only in cold storage warehouses approved by the Administrator and located in the area north of 39° latitude and east of 104° longitude or at one of the following VerDate Sep<11>2014 11:19 Mar 20, 2017 Jkt 241016 PO 00000 Frm 00184 Fmt 8010 Sfmt 8010 Y:\SGML\241016.XXX 241016pm a n g ru m o n D S K 4 S P T V N 1 P R O D w ith C F R 175 Animal and Plant Health Inspection Service, USDA § 305.6 ports: The maritime ports of Wil mington, NC; Seattle, WA; Corpus Christi, TX; and Gulfport, MS; Seattle Tacoma International Airport, Seattle, WA; MidAmerica St. Louis Airport, Mascoutah, IL; and Hartsfield-Atlanta International Airport, Atlanta, GA. (c) Cold treatment enclosures. All en closures, in which cold treatment is performed, including refrigerated con tainers, must: (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 treat ment schedule before the treatment be gins 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 consecu tive hourly readings. (3) Be structurally sound and ade quate to maintain required tempera tures. (d) Treatment procedures. (1) All mate rial, labor, and equipment for cold treatment performed on a vessel must be provided by the vessel or vessel agent. An official authorized by APHIS monitors, manages, and advises in order to ensure that the treatment pro cedures are followed. (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 in fested 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 begin ning treatment. The in-transit treat ment enclosure may not be used for precooling unless an official authorized by APHIS approves the loading of the fruit in the treatment enclosure as ade quate to allow for fruit pulp tempera tures to be taken prior to beginning treatment. If the fruit is precooled out side the treatment enclosure, an offi cial authorized by APHIS will take pulp temperatures manually from a sample of the fruit as the fruit is load ed 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 sam ple was taken will be rejected and re turned for additional precooling until the fruit reaches the highest tempera ture of the treatment schedule under which the fruit will be treated. If fruit is precooled in the treatment enclo sure, 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 treat ment schedule under which the fruit will be treated, as verified by an offi cial authorized by APHIS, prior to be ginning treatment. (5) Breaks, damage, etc., in the treat ment enclosure that preclude main taining correct temperatures must be repaired before the enclosure is used. An official authorized by APHIS must approve loading of compartment, num ber and placement of temperature probes or sensors, and initial fruit tem perature 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 ap proval 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 destina tion 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 in tegrity of cold treatment data. The de vices must be able to record the date, time, and sensor number and auto matic and continuous records of the temperature during all calibrations and during treatment. Recording de vices must be capable of generating temperature charts for verification by an inspector. If records of calibrations VerDate Sep<11>2014 11:19 Mar 20, 2017 Jkt 241016 PO 00000 Frm 00185 Fmt 8010 Sfmt 8010 Y:\SGML\241016.XXX 241016pm a n g ru m o n D S K 4 S P T V N 1 P R O D w ith C F R 176 7 CFR Ch. III (1–1–17 Edition) § 305.6 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’ deci sion 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 treat ment enclosures. An official authorized by APHIS will have the option to re quire 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 speci fied 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 in validation of the treatment unless an official authorized by APHIS can verify that the pulp temperature was main tained at or below the treatment tem perature for the duration of the treat ment. (10) The time required to complete the treatment begins when all tem perature probes reach the prescribed cold treatment schedule temperature. Refrigeration continues until the ves sel 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 au thorized 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 author ized by APHIS or the certifying official of the foreign country; consignments of treated commodities may not be dis charged 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 ini tiated by an official authorized by APHIS if there is not a treatment tech nician 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 accord ance with the treatment schedules in the PPQ Treatment Manual or in ac cordance with another approved treat ment schedule. The official authorized by APHIS must be given the appro priate materials and access to the fa cility, container, or vessel necessary to perform the audits. (15) An inspector will sample and cut fruit from each consignment cold treated for Mediterranean fruit fly (Medfly) to monitor treatment effec tiveness. If a single live Medfly in any stage of development is found, the con signment will be held until an inves tigation is completed and appropriate remedial actions have been imple mented. If APHIS determines at any time that the safeguards contained in this section do not appear to be effec tive against the Medfly, APHIS may suspend the importation of fruits from the originating country and conduct an investigation into the cause of the defi ciency. (16) The cold treatments required for the entry of fruit are considered nec essary 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 treat ments may result in injury to the fruit or its rejection for entry. (e) Monitoring. Treatment must be monitored by an inspector to ensure proper administration of the treat ment. An inspector must also approve the recording devices and sensors used to monitor temperatures and conduct VerDate Sep<11>2014 11:19 Mar 20, 2017 Jkt 241016 PO 00000 Frm 00186 Fmt 8010 Sfmt 8010 Y:\SGML\241016.XXX 241016pm a n g ru m o n D S K 4 S P T V N 1 P R O D w ith C F R 177 Animal and Plant Health Inspection Service, USDA § 305.6 an operational check of the equipment before each use and ensure sensors are calibrated. An inspector may approve, adjust, or reject the treatment. (f) Compliance agreements. Facilities located in the United States must oper ate under a compliance agreement with APHIS. The compliance agreement must be signed by a representative of the cold treatment facility and APHIS. The compliance agreement must con tain requirements for equipment, tem perature, circulation, and other oper ational requirements for performing cold treatment to ensure that treat ments are administered properly. Com pliance agreements must allow offi cials of APHIS to inspect the facility to monitor compliance with the regula tions. (g) Workplans. Facilities located out side the United States may operate in accordance with a bilateral workplan. The workplan, if and when required, must be signed by a representative of the cold treatment facility, the na tional plant protection organization (NPPO) of the country of origin, and APHIS. The workplans must contain requirements for equipment, tempera ture, circulation, and other operational requirements for performing cold treatment to ensure that cold treat ments are administered properly. Workplans for facilities outside the United States may also include trust fund agreement information regarding payment of the salaries and expenses of APHIS employees on site. Workplans must allow officials of the NPPO and APHIS to inspect the facility to mon itor compliance with APHIS regula tions. (h) Additional requirements for treat ments performed after arrival in the United States. (1) Maritime port of Wilmington, NC. Consignments of fruit arriving at the maritime port of Wilmington, NC, for cold treatment, in addition to meeting all other applicable requirements of this section, must meet the following special conditions: (i) Bulk consignments (those consign ments which are stowed and unloaded by the case or bin) of fruit must arrive in fruit fly-proof packaging that pre vents the escape of adult, larval, or pupal fruit flies. (ii) Bulk and containerized consign ments of fruit must be cold-treated within the area over which the U.S. De partment of Homeland Security is as signed the authority to accept entries of merchandise, to collect duties, and to enforce the various provisions of the customs and navigation laws in force. (iii) Advance reservations for cold treatment space must be made prior to the departure of a consignment from its port of origin. (iv) The cold treatment facility must remain locked during non-working hours. (2) Maritime port of Seattle, WA. Con signments of fruit arriving at the mari time port of Seattle, WA, for cold treatment, in addition to meeting all other applicable requirements of this section, must meet the following spe cial conditions: (i) Bulk consignments (those consign ments which are stowed and unloaded by the case or bin) of fruit must arrive in fruit fly-proof packaging that pre vents the escape of adult, larval, or pupal fruit flies. (ii) Bulk and containerized consign ments of fruit must be cold treated within the area over which the U.S. De partment of Homeland Security is as signed the authority to accept entries of merchandise, to collect duties, and to enforce the various provisions of the customs and navigation laws in force. (iii) Advance reservations for cold treatment space must be made prior to the departure of a consignment from its port of origin. (iv) The cold treatment facility must remain locked during non-working hours. (v) Black light or sticky paper must be used within the cold treatment fa cility, and other trapping methods, in cluding APHIS-approved fruit fly traps, must be used within the 4 square miles surrounding the cold treatment facil ity. (vi) The cold treatment facility must have contingency plans, approved by the Administrator, for safely destroy ing or disposing of fruit. (3) Airports of Atlanta, GA, and Seattle, WA. Consignments of fruit arriving at VerDate Sep<11>2014 11:19 Mar 20, 2017 Jkt 241016 PO 00000 Frm 00187 Fmt 8010 Sfmt 8010 Y:\SGML\241016.XXX 241016pm a n g ru m o n D S K 4 S P T V N 1 P R O D w ith C F R 178 7 CFR Ch. III (1–1–17 Edition) § 305.6 the airports of Atlanta, GA, and Se attle, WA, for cold treatment, in addi tion to meeting all other applicable re quirements of this section, must meet the following special conditions: (i) Bulk and containerized consign ments of fruit must arrive in fruit fly proof packaging that prevents the es cape of adult, larval, or pupal fruit flies. (ii) Bulk and containerized consign ments of fruit arriving for cold treat ment must be cold treated within the area over which the U.S. Department of Homeland Security is assigned the authority to accept entries of merchan dise, to collect duties, and to enforce the various provisions of the customs and navigation laws in force. (iii) The cold treatment facility and APHIS must agree in advance on the route by which consignments are al lowed to move between the aircraft on which they arrived at the airport and the cold treatment facility. The move ment of consignments from aircraft to a cold treatment facility will not be al lowed until an acceptable route has been agreed upon. (iv) Advance reservations for cold treatment space must be made prior to the departure of a consignment from its port of origin. (v) The cold treatment facility must remain locked during non-working hours. (vi) Black light or sticky paper must be used within the cold treatment fa cility, and other trapping methods, in cluding APHIS-approved fruit fly traps, must be used within the 4 square miles surrounding the cold treatment facil ity. (vii) The cold treatment facility must have contingency plans, approved by the Administrator, for safely de stroying or disposing of fruit. (4) Maritime ports of Gulfport, MS, and Corpus Christi, TX. Consignments of fruit arriving at the ports of Gulfport, MS, and Corpus Christi, TX, for cold treatment, in addition to meeting all other applicable requirements of this section, must meet the following spe cial conditions: (i) All fruit entering the port for cold treatment must move in maritime con tainers. No bulk consignments (those consignments which are stowed and un loaded by the case or bin) are per mitted. (ii) Within the container, the fruit in tended for cold treatment must be en closed in fruit fly-proof packaging that prevents the escape of adult, larval, or pupal fruit flies. (iii) All consignments of fruit arriv ing at the port for cold treatment must be cold treated within the area over which the U.S. Department of Home land Security is assigned the authority to accept entries of merchandise, to collect duties, and to enforce the var ious provisions of the customs and navigation laws in force. (iv) The cold treatment facility and APHIS must agree in advance on the route by which consignments are al lowed to move between the vessel on which they arrived at the port and the cold treatment facility. The movement of consignments from vessel to cold treatment facility will not be allowed until an acceptable route has been agreed upon. (v) Advance reservations for cold treatment space at the port must be made prior to the departure of a con signment from its port of origin. (vi) Devanning, the unloading of fruit from containers into the cold treat ment facility, must adhere to the fol lowing requirements: (A) All containers must be unloaded within the cold treatment facility; and (B) Untreated fruit may not be ex posed to the outdoors under any cir cumstances. (vii) The cold treatment facility must remain locked during non-work ing hours. (viii) Black lights or sticky paper must be used within the cold treatment facility, and other trapping methods, including APHIS-approved fruit fly traps, must be used within the 4 square miles surrounding the cold treatment facility at the maritime port of Gulf port, MS, and within the 5 square miles surrounding the cold treatment facility at the maritime port of Corpus Christi, TX. (ix) During cold treatment, a backup system must be available to cold treat the consignments of fruit should the primary system malfunction. The facil ity must also have one or more reefers (cold holding rooms) and methods of VerDate Sep<11>2014 11:19 Mar 20, 2017 Jkt 241016 PO 00000 Frm 00188 Fmt 8010 Sfmt 8010 Y:\SGML\241016.XXX 241016pm a n g ru m o n D S K 4 S P T V N 1 P R O D w ith C F R 179 Animal and Plant Health Inspection Service, USDA § 305.8 identifying lots of treated and un treated fruits. (x) The cold treatment facility must have the ability to conduct methyl bro mide fumigations on site. (xi) The cold treatment facility must have contingency plans, approved by the Administrator, for safely destroy ing or disposing of fruit. (5) Airport of Mascoutah, IL. Consign ments of fruits or vegetables arriving at the MidAmerica St. Louis Airport, Mascoutah, IL, for cold treatment, in addition to meeting all other applica ble requirements of this section, must meet the following special conditions: (i) Bulk and containerized consign ments of fruits or vegetables arriving for cold treatment must be cold treated within the area over which the U.S. De partment of Homeland Security is as signed the authority to accept entries of merchandise, to collect duties, and to enforce the various provisions of the customs and navigation laws in force. (ii) APHIS will evaluate facility safe guards in light of the plant health risks involved and approve the oper ation of a facility in that location sub ject to the following conditions to be agreed upon by the involved parties and included in the compliance agree ment required in § 305.6(f): (A) The facility will only be certified if the Administrator determines that the regulated articles could be safely transported to the facility from the point of entry or origin without signifi cant risk that plant pests will escape in transit to the facility or while the regulated articles are at the facility. (B) Bulk consignments (those con signments which are stowed and un loaded by the case or bin) of fruit must arrive in pest-proof packaging that pre vents the escape of the pests of con cern. (C) The facility must ensure that the pest-proof cartons are off-loaded from containers in a safeguarded environ ment and at no time are the articles to be removed from the cartons prior to treatment. (D) 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. The cold treatment facility and APHIS must agree in advance on the route by which consignments are allowed to move between the aircraft on which they arrived at the airport and the cold treatment facility. The movement of consignments from aircraft to a cold treatment facility will not be allowed until an acceptable route has been agreed upon. (E) The facility must have contin gency plans, approved by the Adminis trator, for safely destroying or dis posing of fruits or vegetables. (F) The facility must maintain phys ical separation of treated articles from untreated articles and apply all re quired safeguards (e.g., larger consign ments are broken up into smaller boxes following treatment and those treated articles are required to be packaged in pest-proof containers per an agreement between the treatment facility and the importer) before releasing to local markets or for movement to other States. [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] § 305.7 Quick freeze treatment require ments. Quick freeze treatment for fruits and vegetables imported into the United States or moved interstate from Ha waii 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. Re quests to authorize quick freeze as a treatment for other fruits and vegeta bles 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. The treatment fa cility must be certified by APHIS. Re certification is required annually, or as often as APHIS directs, depending upon treatments performed, commodities handled, and operations conducted at the facility. In order to be certified, a heat treatment facility must: (1) Have equipment that is capable of adequately circulating air or water (as relevant to the treatment), changing the temperature, and maintaining the VerDate Sep<11>2014 11:19 Mar 20, 2017 Jkt 241016 PO 00000 Frm 00189 Fmt 8010 Sfmt 8010 Y:\SGML\241016.XXX 241016pm a n g ru m o n D S K 4 S P T V N 1 P R O D w ith C F R 180 7 CFR Ch. III (1–1–17 Edition) § 305.9 changed temperature sufficient to meet the treatment schedule param eters in the PPQ Treatment Manual or in another treatment schedule ap proved in accordance with § 305.2. (2) Have equipment used to record, monitor, or sense temperature, main tained 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. Treatment must be monitored by an official authorized by APHIS to ensure proper administration of the treatment. An official author ized by APHIS approves, adjusts, or re jects the treatment. (c) Compliance agreements. Facilities located in the United States must oper ate under a compliance agreement with APHIS. The compliance agreement must be signed by a representative of the heat treatment facilities located in the United States and APHIS. The compliance agreement must contain requirements for equipment, tempera ture, water quality, circulation, and other measures for performing heat treatments to ensure that treatments are administered properly. Compliance agreements must allow officials of APHIS to inspect the facility to mon itor compliance with the regulations. (d) Workplans. Facilities located out side the United States must operate in accordance with a workplan. The workplan must be signed by a rep resentative of the heat treatment fa cilities located outside the United States, the national plant protection organization of the country of origin (NPPO), and APHIS. The workplan must contain requirements for equip ment, temperature, water quality, cir culation, and other measures to ensure that heat treatments are administered properly. Workplans for facilities out side the United States must include trust fund agreement information re garding payment of the salaries and ex penses of APHIS employees on site. Workplans must allow officials of the NPPO and APHIS to inspect the facil ity to monitor compliance with APHIS regulations. (e) Treatment procedures. (1) Before each treatment can begin, an official authorized by APHIS must approve the loading of the commodity in the treat ment container. (2) Sensor equipment must be ade quate 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 treat ment schedule has been reached. An of ficial 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 require ments. Irradiation, carried out in accordance with the provisions of this section, is approved as a treatment for any im ported regulated article (i.e., fruits, vegetables, cut flowers, and foliage); for any regulated article moved inter state from Hawaii, Puerto Rico, the U.S. Virgin Islands, Guam, and the Commonwealth of the Northern Mari anas Islands (referred to collectively, in this section, as Hawaii and U.S. ter ritories); 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 con sumption, as apparel or as a similar personal accessory, or for decorative use. (a) Location of facilities. (1) Where cer tified irradiation facilities are avail able, an approved irradiation treat ment may be conducted for any im ported regulated article either prior to shipment to the United States or in the United States. For any regulated arti cle moved interstate from Hawaii or U.S. territories, irradiation treatment may be conducted either prior to move ment to the mainland United States or VerDate Sep<11>2014 11:19 Mar 20, 2017 Jkt 241016 PO 00000 Frm 00190 Fmt 8010 Sfmt 8010 Y:\SGML\241016.XXX 241016pm a n g ru m o n D S K 4 S P T V N 1 P R O D w ith C F R 181 Animal and Plant Health Inspection Service, USDA § 305.9 in the mainland United States. Irradia tion facilities may be located in any State on the mainland United States. For irradiation facilities located in the States of Alabama, Arizona, California, Florida, Georgia, Kentucky, Louisiana, Mississippi, Nevada, New Mexico, North Carolina, South Carolina, Ten nessee, Texas, and Virginia, the fol lowing additional conditions must be met: (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 lay out of the facility site. APHIS will only approve a proposed facility if the Administrator determines that regu lated 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 establish ment of the facility or, if it does not concur, must provide a written expla nation of concern based on pest risks. In instances where the State govern ment does not concur with the pro posed facility location, APHIS and the State will agree on a strategy to re solve the pest risk concerns prior to APHIS approval. (iii) Untreated articles may not be removed from their packaging prior to treatment under any circumstances. (iv) The facility must have contin gency plans, approved by APHIS, for safely destroying or disposing of regu lated articles if the facility is unable to properly treat a shipment. (v) The facility may only treat arti cles 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 consign ment will move from the port of entry or points of origin in the United States to the treatment facility. (vii) Regulated articles must be con veyed to the facility in a refrigerated (via motorized refrigeration equipment or other methods including ice or insu lation) 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 ne cessitate trapping or other pest moni toring activities to help prevent estab lishment of any escaped pests of con cern, as approved by APHIS; these ac tivities 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 es cape 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 fac tors of concern. These activities will be listed in the compliance agreement re quired in paragraph (c)(1)(i) of this sec tion. (2) For articles that are moved inter state from areas quarantined for fruit flies, irradiation facilities may be lo cated either within or outside of the quarantined area. If the articles are treated outside the quarantined area, they must be accompanied to the facil ity by a limited permit issued in ac cordance with § 301.32-5(b) of this chap ter and must be moved in accordance with any safeguards determined to be appropriate by APHIS. (3) For articles that are moved inter state from areas quarantined only for Asian citrus psyllid, and not for citrus greening, irradiation facilities must be located within an area that is not quar antined for citrus greening. (b) Approved facilities. The irradiation treatment facility must be approved by APHIS. Other agencies that have regu latory oversight and requirements must concur in writing with the estab lishment of the facility prior to APHIS VerDate Sep<11>2014 11:19 Mar 20, 2017 Jkt 241016 PO 00000 Frm 00191 Fmt 8010 Sfmt 8010 Y:\SGML\241016.XXX 241016pm a n g ru m o n D S K 4 S P T V N 1 P R O D w ith C F R 182 7 CFR Ch. III (1–1–17 Edition) § 305.9 1 The maximum absorbed ionizing radi ation dose and the irradiation of food is reg ulated by the Food and Drug Administration under 21 CFR part 179. approval. In order to be approved, a fa cility must fulfill the requirements in paragraphs (c) and (d) of this section. (c) Compliance agreements. Compli ance agreements for facilities located in States listed in paragraph (a)(1) of this section may also contain addi tional provisions as described in para graphs (a)(1)(i) through (a)(1)(ix) of this section. (1) Irradiation facilities treating imported articles. (i) Compliance agree ments with importers and facility opera tors for irradiation in the United States. If irradiation of imported articles is con ducted in the United States, both the importer and the operator of the irra diation facility must sign compliance agreements with APHIS. In the facility compliance agreement, the facility op erator must agree to comply with any additional requirements found nec essary by APHIS to prevent the escape, prior to irradiation, of any pests of concern that may be associated with the articles to be irradiated. In the im porter compliance agreement, the im porter must agree to comply with any additional requirements found nec essary by APHIS to ensure the ship ment is not diverted to a destination other than an approved treatment fa cility 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. (ii) Compliance agreement with irradia tion facilities outside the United States. If irradiation of imported articles is con ducted outside the United States, the operator of the irradiation facility must sign a compliance agreement with APHIS and the national plant protection organization (NPPO) of the country in which the facility is lo cated. In this agreement, the facility operator must agree to comply with the requirements of this section, and the NPPO of the country in which the facility is located must agree to mon itor that compliance and to inform the Administrator of any noncompliance. (2) Irradiation facilities treating articles moved interstate from Hawaii and U.S. territories. Irradiation facilities treat ing articles moved interstate from Ha waii and U.S. territories must com plete a compliance agreement with APHIS as provided in § 318.13-3(d) of this chapter. (3) Irradiation facilities treating articles moved interstate from areas quarantined for fruit flies. Irradiation facilities treating articles moved interstate from areas quarantined for fruit flies must complete a compliance agreement with APHIS as provided in § 301.32-6 of this chapter. (4) Irradiation facilities treating arti cles moved interstate from areas quar antined only for Asian citrus psyllid, and not for citrus greening, must com plete a compliance agreement with APHIS as provided in § 301.76-8 of this chapter. (d) Certified facility. The irradiation treatment facility must be certified by APHIS. Recertification is required in the event of an increase in the amount of radioisotope, a decrease in the amount of radioisotope for a reason other than natural decay, a major modification to equipment that affects the delivered dose, or a change in the owner or managing entity of the facil ity. Recertification also may be re quired 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 the PPQ Treatment Manual or in another treatment sched ule approved in accordance with § 305.2 to the regulated articles;1 (2) Be constructed so as to provide physically separate locations for treat ed 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 bar rier such as a wall or chain link fence 6 or more feet high to prevent transfer of cartons, or some other means ap proved 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 VerDate Sep<11>2014 11:19 Mar 20, 2017 Jkt 241016 PO 00000 Frm 00192 Fmt 8010 Sfmt 8010 Y:\SGML\241016.XXX 241016pm a n g ru m o n D S K 4 S P T V N 1 P R O D w ith C F R 183 Animal and Plant Health Inspection Service, USDA § 305.9 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 agree ments. Treatment must be monitored by an inspector. This monitoring will include inspection of treatment records and unannounced inspections of the fa cility by an inspector, and may include inspection of articles prior to or after irradiation. Facilities must be located within the local commuting area for APHIS employees for inspection pur poses. (1) Irradiation facilities treating im ported articles; irradiation treatment framework equivalency workplan. Facili ties shall be located within an area over which the U.S. Department of Homeland Security is assigned author ity to accept entries of merchandise, to collect duties, and to enforce the provi sions of the customs and navigation laws in force. The NPPO of a country from which articles are to be imported into the United States in accordance with this section must sign a frame work equivalency workplan with APHIS. In this plan, both the NPPO and APHIS will specify the following items for their respective countries: (A) Citations for any requirements that apply to the importation of irradi ated fruits and vegetables; (B) The type and amount of inspec tion, monitoring, or other activities that will be required in connection with allowing the importation of irra diated fruits and vegetables into that country; and (C) Any other conditions that must be met to allow the importation of ir radiated fruits and vegetables into that country. (2) Irradiation facilities located in for eign countries. Facilities in foreign countries that carry out irradiation op erations 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, ex cept where otherwise provided in the facility preclearance workplan. To en sure the appropriate level of moni toring, before articles may be imported in accordance with this section, the following agreements must be signed, in addition to the irradiation treat ment framework equivalency workplan required in paragraph (e)(1) of this sec tion: (i) Facility preclearance workplan. Prior to commencing importation into the United States of articles treated at a foreign irradiation facility, APHIS and the NPPO of the country from which articles are to be imported must jointly develop a preclearance workplan that details the activities that APHIS and the foreign NPPO will carry out in connection with each irra diation facility to verify the facility’s compliance with the requirements of this section. Typical activities to be described in this workplan may include frequency of visits to the facility by APHIS and foreign plant protection in spectors, methods for reviewing facil ity records, and methods for verifying that facilities are in compliance with the requirements for separation of arti cles, packaging, labeling, and other re quirements of this section. This facil ity preclearance workplan will be re viewed and renewed by APHIS and the foreign NPPO on an annual basis. (ii) Trust fund agreement. Irradiated articles may be imported into the United States in accordance with this section only if the NPPO of the coun try in which the irradiation facility is located or a private export group has entered into a trust fund agreement with APHIS. That agreement requires the NPPO or the private export group to pay, in advance of each shipping sea son, all costs that APHIS estimates it will incur in providing inspection and treatment monitoring services at the irradiation facility during that ship ping season. Those costs include ad ministrative expenses and all salaries (including overtime and the Federal share of employee benefits), travel ex penses (including per diem expenses), and other incidental expenses incurred by APHIS in performing these services. The agreement will describe the gen eral nature and scope of APHIS serv ices provided at irradiation facilities covered by the agreement, such as whether APHIS inspectors will monitor VerDate Sep<11>2014 11:19 Mar 20, 2017 Jkt 241016 PO 00000 Frm 00193 Fmt 8010 Sfmt 8010 Y:\SGML\241016.XXX 241016pm a n g ru m o n D S K 4 S P T V N 1 P R O D w ith C F R 184 7 CFR Ch. III (1–1–17 Edition) § 305.9 2 Inspectors are assigned to local offices of the Animal and Plant Health Inspection Service, which are listed in telephone direc tories. 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, Center for Plant Health Inspection and Tech nology, 1730 Varsity Drive, Suite 400, Ra leigh, NC 27606-5202. operations continuously or intermit tently, and will generally describe the extent of inspections APHIS will per form on articles prior to and after irra diation. The agreement requires the NPPO or private export group to de posit 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 in curred by APHIS, the agreement fur ther requires the NPPO or the private export group to deposit with APHIS a certified or cashier’s check for the amount of the remaining costs, as de termined 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 NPPO or the private export group or held on account until needed, at the option of the NPPO or the private ex port group. (3) Irradiation facilities located within the United States. Facilities located within the United States must notify an inspector at least 24 hours (exclud ing Saturday, Sunday, and Federal holidays) before scheduled operations. 2 If the facility will be used to treat im ported articles, the NPPO of the coun try from which the articles are to be imported into the United States in ac cordance with this section must also sign the irradiation treatment frame work equivalency workplan required in paragraph (e)(1) of this section. (f) Packaging. Articles that are irradi ated in accordance with this section must be packaged in cartons in the fol lowing manner: (1) Irradiated articles may not be packaged for shipment in a carton with nonirradiated articles. (2) For all imported articles irradi ated prior to arrival in the United States, all articles moved interstate from Hawaii or U.S. territories and ir radiated prior to arrival in the main land 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 vis ually indicate if the cartons have been opened. The cartons may be con structed of any material that prevents entry or oviposition (if applicable) by the pests of concern into the articles in the carton;3 or (B) In noninsect-proof cartons that are stored immediately after irradia tion in a room completely enclosed by walls or screening that completely pre cludes 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 com pletely enclosed in polyethylene shrink wrap, or another solid or netting cov ering that completely precludes access to the cartons by the pests of concern. (ii) To preserve the integrity of treat ed lots, each pallet-load of cartons con taining the fruits and vegetables must be secured before leaving the irradia tion 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 de termine treatment lot numbers, pack ing and treatment facility identifica tion 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 pal let. 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 VerDate Sep<11>2014 11:19 Mar 20, 2017 Jkt 241016 PO 00000 Frm 00194 Fmt 8010 Sfmt 8010 Y:\SGML\241016.XXX 241016pm a n g ru m o n D S K 4 S P T V N 1 P R O D w ith C F R 185 Animal and Plant Health Inspection Service, USDA § 305.9 4 Designation ISO/ASTM 51261-2002(E), ‘‘Standard Guide for Selection and Calibra tion of Dosimetry Systems for Radiation Processing,’’ American Society for Testing and Materials, Annual Book of ASTM Stand ards. 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 informa tion on each individual carton. (3) For all articles imported to be ir radiated 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 cit rus psyllid to be irradiated outside the quarantined area, the articles must be packed in cartons that have no open ings 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 un treated articles must be shipped in shipping containers sealed prior to their shipment with seals that will vis ually indicate if the shipping con tainers have been opened. (g) Containers or vans. Containers or vans that will transport treated arti cles must be free of pests of concern prior to loading the treated articles. (h) Certification of treatment for articles treated outside the United States. For each consignment treated in an irra diation facility outside the United States, a phytosanitary certificate, with the treatment section completed and issued by the NPPO, must accom pany the consignment. (i) Dosage. The regulated articles must receive the minimum absorbed ionizing radiation dose specified in the PPQ Treatment Manual or in another approved treatment schedule. (j) Dosimetry systems at the irradiation facility. (1) Dosimetry must indicate the doses needed to ensure that all the articles will receive the minimum dose prescribed. (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 an other approved treatment schedule. (3) When designing the facility’s do simetry system and procedures for its operation, the facility operator must address guidance and principles from the International Standards Organiza tion/American Society for Testing and Materials standard 4 or an equivalent standard recognized by APHIS. (k) 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, ex cept holidays). These records must in clude 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. (l) Request for initial certification and inspection of facility. Persons requesting initial certification of an irradiation treatment facility must submit the re quest for approval in writing to the Animal and Plant Health Inspection Service, Plant Protection and Quar antine, Center for Plant Health Inspec tion and Technology, 1730 Varsity Drive, Suite 400, Raleigh, NC 27606-5202. 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 eligi ble for certification, an inspector will VerDate Sep<11>2014 11:19 Mar 20, 2017 Jkt 241016 PO 00000 Frm 00195 Fmt 8010 Sfmt 8010 Y:\SGML\241016.XXX 241016pm a n g ru m o n D S K 4 S P T V N 1 P R O D w ith C F R 186 7 CFR Ch. III (1–1–17 Edition) Pt. 318 make a personal inspection of the facil ity to determine whether it complies with the standards of this section. (m) Denial and withdrawal of certifi cation. (1) The Administrator will with draw the certification of any irradia tion treatment facility upon written request from the irradiation processor. (2) The Administrator will deny or withdraw certification of an irradia tion treatment facility when any provi sion of this section is not met. Before withdrawing or denying certification, the Administrator will inform the irra diation processor in writing of the rea sons for the proposed action and pro vide the irradiation processor with an opportunity to respond. The Adminis trator will give the irradiation proc essor an opportunity for a hearing re garding any dispute of a material fact, in accordance with rules of practice that will be adopted for the proceeding. However, the Administrator will sus pend certification pending final deter mination in the proceeding if he or she determines that suspension is nec essary to prevent the spread of any dangerous insect. The suspension will be effective upon oral or written notifi cation, whichever is earlier, to the ir radiation processor. In the event of oral notification, written confirmation will be given to the irradiation proc essor within 10 days of the oral notifi cation. The suspension will continue in effect pending completion of the pro ceeding and any judicial review of the proceeding. (n) Department not responsible for dam age. This treatment is approved to as sure quarantine security against the plant pests listed in the PPQ Treat ment Manual or the plant pests for which another treatment schedule is approved in accordance with § 305.2. From the literature available, the arti cles 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 De partment of Agriculture and its inspec tors assume no responsibility for any loss or damage resulting from any treatment prescribed or monitored. Ad ditionally, the Nuclear Regulatory Commission is responsible for ensuring that irradiation facilities are con structed and operated in a safe manner. Further, the Food and Drug Adminis tration is responsible for ensuring that irradiated foods are safe and whole some for human consumption. (o) Substitution of irradiation for other treatments. Treatment of fruits and vegetables that are from foreign local ities, from Hawaii, Puerto Rico, and the U.S. Virgin Islands, or from domes tic areas under quarantine with irra diation in accordance with this section may be substituted for other approved treatments if the target pests of the other approved treatments are ap proved for treatment with irradiation in the PPQ Treatment Manual or ap proved for treatment with irradiation in accordance with § 305.2. (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] PART 318—STATE OF HAWAII AND TERRITORIES QUARANTINE NOTICES Subpart—Regulated Articles From Hawaii and the Territories Sec. 318.13–1 Notice of quarantine. 318.13–2 Definitions. 318.13–3 General requirements for all regu lated articles. 318.13–4 Approval of certain fruits and vege tables for interstate movement. 318.13–5 Pest-free areas. 318.13–6 Transit of regulated articles from Hawaii or the territories into or through the continental United States. 318.13–7 Products as ships’ stores or in the possession of passengers or crew. 318.13–8 Articles and persons subject to in spection. 318.13–9 Inspection and disinfection of means of conveyance. 318.13–10 Inspection of baggage, other per sonal effects, and cargo. 318.13–11 Posting of warning notice and dis tribution of baggage declarations. 318.13–12 Movement by the U.S. Department of Agriculture. 318.13–13 Movement of frozen fruits and vegetables. 318.13–14 Movement of processed fruits, vegetables, and other products. 318.13–15 Parcel post inspection. 318.13–16 Regulated articles allowed inter state movement subject to specified con ditions. VerDate Sep<11>2014 11:19 Mar 20, 2017 Jkt 241016 PO 00000 Frm 00196 Fmt 8010 Sfmt 8010 Y:\SGML\241016.XXX 241016pm a n g ru m o n D S K 4 S P T V N 1 P R O D w ith C F R