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the interstate movement of any regulated article from an area temporarily designated as a quarantined area is subject to this subpart. As soon as practicable, this area will be added to the list in paragraph (c) of this section or the designation shall be terminated by the Administrator or an inspector. The owner or person in possession of an area for which designation is terminated will be given notice of the termination as soon as practicable.

(c) There are no areas in the continental United States quarantined because of the Mediterranean fruit fly. (56 FR 57576, Nov. 13, 1991]

EDITORIAL NOTE: For FEDERAL REGISTER citations affecting $301.78–3, see the List of CFR Sections Affected in the Finding Aids section of this volume.

moved through (without stopping except for refueling, or for traffic conditions, such as traffic lights or stop signs) the quarantined area in an enclosed vehicle or is completely enclosed by a covering adequate to prevent access by Mediterranean fruit flies (such as canvas, plastic, or other closely woven cloth) while moving through the quarantined area; and

(2) The point of origin of the regulated article is indicated on the waybill, and the enclosed vehicle or the enclosure that contains the regulated article is not opened, unpacked, or unloaded in the quarantined area.

(d) Without a certificate or limited permit if the regulated article is moved:

(1) By the United States Department of Agriculture for experimental or scientific purposes;

(2) Pursuant to a permit issued by the Administrator for the regulated article;

(3) Under conditions specified on the permit and found by the Administrator to be adequate to prevent the spread of Mediterranean fruit fly; and

(4) With a tag or label bearing the number of the permit issued for the regulated article attached to the outside of the container of the regulated article or attached to the regulated article itself if not in a container. (Approved by the Office of Management and Budget under control number 0579 0088)

8301.784 Conditions governing the

interstate movement of regulated

articles from quarantined areas. Any regulated article may be moved interstate from a quarantined area 2 only if moved under the following conditions:

(a) With a certificate or limited permit issued and attached in accordance with $$ 301.78–5 and 301.78–8 of this subpart;

(b) Without a certificate or limited permit, if:

(1) The regulated article is moving as air cargo or as a meal intended for inflight consumption, and is transiting Los Angeles International Airport, California;

(2) The regulated article originated outside the quarantined area and is either moved in an enclosed vehicle or is completely enclosed by a covering adequate to prevent access by Mediterranean fruit flies (such as canvas, plastic, or other closely woven cloth) while moving through the quarantined area; and

(3) The point of origin of the regulated article is indicated on the waybill.

(c) Without a certificate or limited permit, if:

(1) The regulated article originated outside any quarantined area and is

[56 FR 57576, Nov. 13, 1991, as amended at 57 FR 54169, Nov. 17, 1992]

8 301.785 Issuance and cancellation of

certificates and limited permits. (a) A certificate shall be issued by an inspector3 for the interstate movement of a regulated article if the inspector determines that:

3 Services of an inspector may be requested by contacting local offices of Plant Protection and Quarantine, which are listed in telephone directories. The addresses and telephone numbers of local offices may also be obtained from the Animal and Plant Health Inspection Service, Plant Protection and Quarantine, Domestic and Emergency Operations, 4700 River Road Unit 134, Riverdale, Maryland 20737–1236.

2 Requirements under all other applicable Federal domestic plant quarantines and regulations must also be met.

(1)(i) The regulated article has been treated under the direction of an inspector in accordance with 8301.78–10 of this subpart; or

(ii) Based on inspection of the premises of origin, that the premises are free from the Mediterranean fruit fly; or

(iii) Based on inspection of the regulated article, that it is free of Mediterranean fruit fly; and

(2) The regulated article will be moved through the quarantined area in an enclosed vehicle or is completely enclosed by a covering adequate to prevent access by Mediterranean fruit fly; and

(3) The regulated article is to be moved in compliance with any additional emergency conditions the Administrator may impose, under section 105 of the Federal Plant Pest Act (7 U.S.C. 150dd),4 to prevent the spread of the Mediterranean fruit fly; and

(4) The regulated articles is eligible for unrestricted movement under all other Federal domestic plant quarantines and regulations applicable to the regulated articles.

(b) An inspector 5 will issue a limited permit for the interstate movement of a regulated article if the inspector determines that,

(1) The regulated article is to be moved interstate to a specified destination for specified handling, processing,

utilization (the destination and other conditions to be listed in the limited permit), and this interstate movement will not result in the spread of the Mediterranean fruit fly because life stages of the Mediterranean fruit fly will be destroyed by the specified handling, processing, or utilization;

(2) The regulated article is to be moved in compliance with any additional emergency conditions the Administrator may impose, under section 105 of the Federal Plant Pest Act (7

U.S.C. 150dd), to prevent the spread of the Mediterranean fruit fly; and

(3) The regulated article is eligible for interstate movement under all other Federal domestic plant quarantines and regulations applicable to the regulated article.

(c) Certificates and limited permits for use for interstate movement of regulated articles may be issued by an inspector or person operating under a compliance agreement. A person operating under a compliance agreement may issue a certificate for the interstate movement of a regulated article if an inspector has determined that the regulated article is otherwise eligible for a certificate in accordance with paragraph (a) of this section. A person operating under a compliance agreement may issue a limited permit for interstate movement of a regulated article when an inspector has determined that the regulated article is eligible for a limited permit in accordance with paragraph (b) of this section.

(d) Any certificate or limited permit that has been issued may be withdrawn by an inspector orally or in writing, if he or she determines that the holder of the certificate or limited permit has not complied with all conditions under this subpart for the use of the certificate or limited permit. If the withdrawal is oral, the withdrawal and the reasons for the withdrawal shall be confirmed in writing as promptly as circumstances allow. Any person whose certificate or limited permit has been withdrawn may appeal the decision in writing to the Administrator within 10 days after receiving the written notification of the withdrawal. The appeal must state all of the facts and reasons upon which the person relies to show that the certificate or limited permit was wrongfully withdrawn. As promptly as circumstances allow, the Administrator will grant or deny the appeal, in writing, stating the reasons for the decision. A hearing will be held to resolve any conflict as to any material fact. Rules of practice concerning a hearing will be adopted by the Administrator. (Approved by the Office of Management and Budget under control number 0579-0088) (56 FR 57576, Nov. 13, 1991, as amended at 59 FR 67608, Dec. 30, 1994]

or

4 Section 105 of the Federal Plant Pest Act (7 U.S.C. 150dd) provides that the Secretary of Agriculture may—under certain conditions—seize, quarantine, treat, destroy, or apply other remedial measures to articles that the Administrator has reason to believe are infested or infected by or contain plan pests.

5 See footnote 3 to 8 301.78–5(a).

(but no less than 48 hours before the desired interstate movement).

(b) The regulated article must be assembled at the place and in the manner the inspector designates as necessary to comply with this subpart.

8301.78 6 Compliance agreements and

cancellation. (a) Any person engaged in growing, handling, or moving regulated articles may enter into a compliance agreement when an inspector determines that the person understands this subpart.6

(b) Any compliance agreement may be canceled orally or in writing by an inspector whenever the inspector finds that the person who has entered into the compliance agreement has failed to comply with this subpart. If the cancellation is oral, the cancellation and the reasons for the cancellation shall be confirmed in writing as promptly as circumstances allow. Any person whose compliance agreement has been canceled may appeal the decision, in writing, within 10 days after receiving written notification of the cancellation. The appeal must state all of the facts and reasons upon which the person relies to show that the compliance agreement

wrongfully canceled. As promptly as circumstances allow, the Administrator will grant or deny the appeal, in ing, stating the reasons for the decision. A hearing will be held to resolve any conflict as to any material fact. Rules of practice concerning a hearing will be adopted by the Administrator.

8301.78-8 Attachment and disposition

of certificates and limited permits. (a) A certificate or limited permit required for the interstate movement of a regulated article, at all times during the interstate movement, must be attached to the outside of the container containing the regulated article, attached to the regulated article itself if not in a container, or attached to the consignee's copy of the accompanying waybill: Provided however, that the requirements of this section may be met by attaching the certificate or limited permit to the consignee's copy of the waybill only if the regulated article is sufficiently described on the certificate or limited permit and on the waybill to identify the regulated article.

(b) The certificate or limited permit for the interstate movement of a regulated article must be furnished by the carrier to the consignee at the destination of the regulated article. (Approved by the Office of Management and Budget under control number 0579-0088)

was

[56 FR 57576, Nov. 13, 1991, as amended at 59 FR 67609, Dec. 30, 1994]

8301.78–7 Assembly and inspection of

regulated articles. (a) Any person (other than a person authorized to issue certificates or limited permits under $301.78–5(c)), who desires to move a regulated article interstate accompanied by a certificate or limited permit must notify an inspector,? as far in advance of the desired interstate movement as possible

8301.789 Costs and charges.

The services of the inspector during normal business hours (8 a.m. to 4:30 p.m., Monday through Friday, except holidays) will be furnished without cost. The user will be responsible for all costs and charges arising from inspection and other services provided outside of normal business hours.

6 Compliance agreement forms are available without charge from the Animal and Plant Health Inspection Service, Plant Protection and Quarantine, Domestic and Emergency Operations, 4700 River Road Unit 134, Riverdale, Maryland 20737–1236, and from local offices of the Plant Protection and Quarantine, which are listed in telephone directories.

7 See footnote 3 to 8 301.78–5(a).

8301.78–10 Treatments.

Treatment schedules listed in the Plant Protection and Quarantine Treatment Manual to destroy Mediterranean fruit fly are authorized for use on regulated articles. The Plant Protection and Quarantine Treatment Manual is incorporated by reference. For the full identification of this standard, see $300.1 of this chapter, “Materials incorporated by reference." The following treatments may be used for the regulated articles indicated:

(a) Fruits and vegetables.

(1) Bell Pepper—(i) Vapor Heat. Heat by saturated water vapor at 44.4°C. (112 °F.) until approximate center of bell pepper reaches 44.4 °C. (112 °F.). Maintain at 44.4 °C. (112 °F.) for 83/4 hours, then immediately cool.

(2) Tomato—(i) Fumigation. Fumigate with methyl bromide at normal atmospheric pressure with 32 g/m3 (2 lb/1000 ft3) for 31/2 hours at 21 °C. (70 °F.) or above.

(ii) Vapor heat. Heat by saturated water vapor at 44.4 °C. (112 °F.) until approximate center of tomato reaches 44.4 °C. (112 °F.). Maintain at 44.4 °C. (112 °F.) for 83/4 hours, then immediately cool.

NOTE: Commodities should be tested by the shipper to determine each commodity's tolerance to the treatment before commercial shipments are attempted. The USDA is not liable for damages caused by this quarantine.

(b) Regulated citrus fruit that has been harvested. (1) Fumigation with methyl bromide at normal atmospheric pressure with 32 g/m3 (2 pounds per 1000 cubic feet) for 372 hours at 21 °C. (70 °F.) or above.

NOTE: Some varieties of fruit may be injured by methyl bromide exposure. Shippers should test treat before making commercial shipments.

(2) Fumigation plus refrigeration: Fumigation with methyl bromide at normal atmospheric pressure with 32 g/ m3 (2 pounds per 1000 cubic feet) at 21 °C. (70 °F.) or above.

or below: 14 days at 1.66 °C. (35 °F.) or below; or 16 days at 2.22 °C. (36 °F.) or below.

(c) Approved irradiation treatment. Irradiation, carried out in accordance with the provisions of this paragraph, is approved as a treatment for any berry, fruit, nut, or vegetable listed as a regulated article in $ 301.78–2(a) of this subpart.

(1) Approved facility. The irradiation treatment facility and treatment protocol must be approved by the Animal and Plant Health Inspection Service. In order to be approved, a facility must:

(i) Be capable of administering a minimum absorbed ionizing radiation dose of 225 Gray (22.5 krad) to the fruits and vegetables; 8

(ii) Be constructed so as to provide physically separate locations for treated and untreated fruits and vegetables, except that fruits and vegetables traveling by conveyor directly into the irradiation chamber may pass through an area that would otherwise be separated. The locations must be separated by a permanent physical barrier such as a wall or chain link fence 6 or more feet high to prevent transfer of cartons;

(iii) Complete a compliance agreement with the Animal and Plant Health Inspection Service as provided in 8 301.78–6 of this subpart; and

(iv) Be certified by Plant Protection and Quarantine for initial use and annually for subsequent use. Recertification is required in the event that an increase or decrease in radioisotope or a major modification to equipment that affects the delivered dose. Recertification may be required in cases where a significant variance in dose delivery is indicated.

(2) Treatment monitoring. Treatment must be carried out under the monitoring of an inspector. This monitoring must include inspection of treatment records and unannounced inspection visits to the facility by an inspector. Facilities that carry out continual irradiation operations must notify an inspector at least 24 hours before the

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2 hours

21/2 hours

4 days at 0.55 to 0.7 °C. (33 to 37 °F.); or

11 days at 3.33 to 8.3 °C. (38 to 47 °F.). 4 days at 1.11 to 4.44 °C. (34 to 40 °F.); or

6 days at 5.0 to 8.33 °C. (41 to 47 °F.); or 10 days at 8.88 to 13.33 °C. (48 to 56

°F.). 3 days at 6.11 to 8.33 °C. (43 to 47 °F.); or

6 days at 9.88 to 13.33 °C. (48 to 56 °F.).

3 hours

NOTE: Some varieties of fruit may be injured by methyl bromide exposure. Shippers should test treat before making commercial shipments.

Time lapse between fumigation and start of cooling not to exceed 24 hours. Chamber load not to exceed 80 percent of volume.

(3) Cold treatment: 10 days at 0 °C. (32 °F.) or below; or 11 days at 0.55 °C. (33 °F.) or below; 12 days at 1.11 °C (34 °F.)

8 The maximum absorbed ionizing radiation dose and the irradiation of food is regulated by the Food and Drug Administration under 21 CFR part 179.

date of operations. Facilities that carry out periodic irradiation operations must notify an inspector of scheduled operations at least 24 hours before scheduled operations.

(3) Packaging. Fruits and vegetables that are treated within a quarantined area must be packaged in the following manner:

(i) The cartons must have no openings that will allow the entry of fruit flies and must be sealed with seals that will visually indicate if the cartons have been opened. They may be constructed of any material that prevents the entry of fruit flies and prevents oviposition by fruit flies into the fruit in the carton. 10

(ii) The pallet-load of cartons must be wrapped before it leaves the irradiation facility in one of the following ways:

(A) With polyethylene sheet wrap; (B) With net wrapping; or

(C) With strapping so that each carton on an outside row of the pallet load is constrained by a metal or plastic strap.

(iii) Packaging must be labeled with treatment lot numbers, packing and treatment facility identification and location, and dates of packing and treatment.

(4) Dosage. The fruits and vegetables must receive a minimum absorbed ionizing radiation dose of 225 Gray (22.5 krad).11

(5) Dosimetry systems. (i) Dosimetry must demonstrate that the absorbed dose, including areas of minimum and maximum dose, is mapped, controlled, and recorded.

(ii) Absorbed dose must be measured using a dosimeter that can accurately measure an absorbed dose of 225 Gray (22.5 krad).

(iii) The number and placement of dosimeters used must be in accordance with American Society for Testing and Materials (ASTM) standards. 12

(6) Records. Records or invoices for each treated lot must be made available for inspection by an inspector during normal business hours (8 a.m. to 4:30 p.m., Monday through Friday, except holidays). An irradiation processor must maintain records as specified in this section for a period of time that exceeds the shelf life of the irradiated food product by 1 year, and must make these records available for inspection by an inspector. These records must include the lot identification, scheduled process, evidence of compliance with the scheduled process, ionizing energy source, source calibration, dosimetry, dose distribution in the product, and the date of irradiation.

(7) Request for approval and inspection of facility. Persons requesting approval of an irradiation treatment facility and treatment protocol must submit the request for approval in writing to the Animal and Plant Health Inspection Service, Plant Protection and Quarantine, Oxford Plant Protection Center, 901 Hillsboro St., Oxford, NC 27565. Before the Administrator determines whether an irradiation facility is eligible for approval, an inspector will make a personal inspection of the facility to determine whether it complies with the standards of paragraph (c)(1) of this section.

(8) Denial and withdrawal of approval. (i) The Administrator will withdraw the approval of any irradiation treatment facility when the irradiation processor requests in writing the withdrawal of approval.

(ii) The Administrator will deny or withdraw approval of an irradiation treatment facility when any provision of this section is not met. Before withdrawing or denying approval, the Administrator will inform the irradiation processor in writing of the reasons for the proposed action and provide the irradiation processor with opportunity to respond. The Administrator

an

9 Inspectors are assigned to local offices of the Animal and Plant Health Inspection Service, which are listed in telephone directories.

10 If there is a question as to the adequacy of a carton, send a request for approval of the carton, together with a sample carton, to the Animal and Plant Health Inspection Service, Plant Protection and Quarantine, Phytosanitary Issues Management Team, 4700 River Road Unit 140, Riverdale, Maryland 20737–1236.

11 See footnote 8.

12 Designation E 1261, “Standard Guide for Selection and Calibration of Dosimetry Systems for Radiation Processing,” American Society for Testing and Materials, Annual Book of ASTM Standards.

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