section_id,title_number,title_name,chapter,subchapter,part_number,part_name,subpart,subpart_name,section_number,section_heading,agency,authority,source_citation,amendment_citations,full_text 7:7:5.1.1.1.5.1.19.1,7,Agriculture,III,,318,PART 318—STATE OF HAWAII AND TERRITORIES QUARANTINE NOTICES,A,Subpart A—Regulated Articles From Hawaii and the Territories,,§ 318.13-1 Notice of quarantine.,APHIS,,,"[74 FR 2775, Jan. 16, 2009, as amended at 74 FR 15641, Apr. 7, 2009; 84 FR 2428, Feb. 7, 2019]","(a) Under the authority of section 412 of the Plant Protection Act, the Secretary of Agriculture may prohibit or restrict the movement in interstate commerce of any plant or plant product if the Secretary determines that the prohibition or restriction is necessary to prevent the introduction into the United States or the dissemination within the United States of a plant pest or noxious weed. (b) The Secretary has determined that it is necessary to prohibit the interstate movement of cut flowers and fruits and vegetables and plants and portions of plants from Hawaii, Puerto Rico, the U.S. Virgin Islands, Guam, and the Commonwealth of the Northern Mariana Islands except as provided in this subpart or as provided in “Subpart B—Territorial Cotton, Cottonseed, and Cottonseed Products” and “Subpart C—Sand, Soil, or Earth, with Plants from Territories and Districts” in this part." 7:7:5.1.1.1.5.1.19.10,7,Agriculture,III,,318,PART 318—STATE OF HAWAII AND TERRITORIES QUARANTINE NOTICES,A,Subpart A—Regulated Articles From Hawaii and the Territories,,"§ 318.13-10 Inspection of baggage, other personal effects, and cargo.",APHIS,,,,"(a) Offer for inspection by aircraft passengers. Passengers destined for movement by aircraft from Hawaii, Puerto Rico, Guam, the Commonwealth of the Northern Mariana Islands, or the U.S. Virgin Islands to any other State shall offer their carry-on baggage and other personal effects for inspection at the place marked for agricultural inspections, which will be located at the airport security checkpoint or the aircraft boarding gate, at the time they pass through the checkpoint or the gate. Passengers shall offer their check-in baggage for inspection at agricultural inspection stations prior to submitting their baggage to the check-in baggage facility. When an inspector has inspected and passed such baggage or personal effects, he or she shall apply a U.S. Department of Agriculture stamp, inspection sticker, or other identification to such baggage or personal effects to indicate that such baggage or personal effects have been inspected and passed as required. Passengers shall disclose any fruits, vegetables, plants, plant products, or other articles that are requested to be disclosed by the inspector. When an inspection of a passenger's baggage or personal effects discloses an article in violation of the regulations in this part, the inspector shall seize the article. The passenger shall state his or her name and address to the inspector, and provide the inspector with corroborative identification. The inspector shall record the name and address of the passenger, the nature of the identification presented for corroboration, the nature of the violation, the types of articles involved, and the date, time, and place of the violation. (b) Offer for inspection by aircraft crew. Aircraft crew members destined for movement by aircraft from Hawaii, Puerto Rico, Guam, the Commonwealth of the Northern Mariana Islands, or the U.S. Virgin Islands to any other State, shall offer their baggage and personal effects for inspection at the inspection station designated for the employing airline not less than 20 minutes prior to the scheduled departure time of the aircraft or the rescheduled departure time as posted in the public areas of the airport. When an inspector has inspected and passed such baggage or personal effects, he or she shall apply a U.S. Department of Agriculture stamp, inspection sticker, or other identification to the baggage or personal effects to indicate that such baggage or personal effects have been inspected and passed as required. Aircraft crew members shall disclose any fruits, vegetables, plants, plant products, or other articles that are requested to be disclosed by the inspector. When an inspection of a crew member's baggage or personal effects discloses an article in violation of the regulations in this part, the inspector shall seize the article. The crew member shall state his or her name and address to the inspector, and provide the inspector with corroborative identification. The inspector shall record the name and address of the crew member, the nature of the identification presented for corroboration, the nature of the violation, the types of articles involved, and the date, time, and place of the violation. (c) Baggage inspection for persons traveling to Guam on aircraft. No person who has moved from Hawaii, Puerto Rico, or the U.S. Virgin Islands to Guam on an aircraft shall remove or attempt to remove any baggage or other personal effects from the area secured for customs inspections before the person has offered to an inspector, and has had passed by the inspector, his or her baggage and other personal effects. Persons shall disclose any fruits, vegetables, plants, plant products, or other articles that are requested to be disclosed by the inspector. When an inspection of a person's baggage or personal effects discloses an article in violation of the regulations in this part, the inspector shall seize the article. The person shall state his or her name and address to the inspector, and provide the inspector with corroborative identification. The inspector shall record the name and address of the person, the nature of the identification presented for corroboration, the nature of the violation, the types of articles involved, and the date, time, and place of the violation. (d) Baggage acceptance and loading on aircraft. No person shall accept or load any check-in aircraft baggage destined for movement from Hawaii, Puerto Rico, Guam, the Commonwealth of the Northern Mariana Islands, or the U.S. Virgin Islands to any other State unless the baggage bears a U.S. Department of Agriculture stamp, inspection sticker, or other indication applied by an inspector representing that the baggage has been inspected and certified. (e) Offer for inspection by persons moving by ship. No person who has moved on any ship or other oceangoing craft from Hawaii, Puerto Rico, Guam, the Commonwealth of the Northern Mariana Islands, or the U.S. Virgin Islands to any other territory, State, or District of the United States, shall remove or attempt to remove any baggage or other personal effects from the designated inspection area as provided in paragraph (h) of this section on or off the ship or other oceangoing craft unless the person has offered to an inspector for inspection, and has had passed by the inspector, the baggage and other personal effects. Persons shall disclose any fruits, vegetables, plants, plant products, or other articles that are requested to be disclosed by the inspector. When an inspection of a person's baggage or personal effects discloses an article in violation of the regulations in this part, the inspector shall seize the article. The person shall state his or her name and address to the inspector, and provide the inspector with corroborative identification. The inspector shall record the name and address of the person, the nature of the identification presented for corroboration, the nature of the violation, the types of articles involved, and the date, time, and place of the violation. (f) Loading of certain cargoes. (1) Except as otherwise provided in paragraph (f)(2) of this section, no person shall present to any common carrier or contract carrier for movement, and no common carrier or contract carrier shall load, any cargo containing fruits, vegetables, or other articles regulated under this subpart that are destined for movement from Hawaii, Puerto Rico, Guam, or the U.S. Virgin Islands to any other State unless the cargo has been offered for inspection, passed by an inspector, and bears a U.S. Department of Agriculture stamp or inspection sticker, or unless a limited permit is attached to the cargo as specified in § 318.13-3(e). (2) Cargo designated may be loaded without a U.S. Department of Agriculture stamp or inspection sticker attached to the cargo or a limited permit attached to the cargo if the cargo is moved: (i) As containerized cargo on ships or other oceangoing craft or as air cargo; (ii) The carrier has on file documentary evidence that a valid limited permit was issued for the movement or that the cargo was certified; and (iii) A notation of the existence of these documents is made by the carrier on the waybill, manifest, or bill of lading that accompanies the consignment. (3) Cargo moved in accordance with § 318.13-6(b) that does not have a limited permit attached to the cargo must have a limited permit attached to the waybill, manifest, or bill of lading accompanying the consignment. (g) R emoval of certain cargoes in Guam. No person shall remove or attempt to remove from a designated inspection area as provided in paragraph (h) of this section, on or off the means of conveyance, any cargo moved from Hawaii, Puerto Rico, the Commonwealth of the Northern Mariana Islands, or the U.S. Virgin Islands to Guam containing fruits, vegetables, or other articles regulated under this subpart, unless the cargo has been inspected and passed by an inspector in Guam. (h) Space and facilities for baggage and cargo inspection. Baggage and cargo inspection will not be performed until the person in charge or possession of the ship, other oceangoing craft, or aircraft provides space and facilities on the means of conveyance, pier, or airport that are adequate, in the inspector's judgment, for the performance of inspection." 7:7:5.1.1.1.5.1.19.11,7,Agriculture,III,,318,PART 318—STATE OF HAWAII AND TERRITORIES QUARANTINE NOTICES,A,Subpart A—Regulated Articles From Hawaii and the Territories,,§ 318.13-11 Posting of warning notice and distribution of baggage declarations.,APHIS,,,,"(a) Before any aircraft or any ship, vessel, or other surface craft moving to Guam, the Commonwealth of Northern Mariana Islands, or American Samoa from Hawaii or any other territory or possession of the United States arrives in Guam, the Commonwealth of Northern Mariana Islands, or American Samoa, a baggage declaration, to be furnished by the U.S. Department of Agriculture, calling attention to the provisions of the Plant Protection Act and the quarantine and regulations in this subpart, must be distributed to each adult passenger. These baggage declarations shall be executed and signed by the passengers and shall be collected and delivered by the master or other responsible officer of the aircraft, ship, vessel, or other surface craft to the inspector on arrival at the quarantine or inspection area. (b) Every person owning or controlling any dock, harbor, or landing field in Hawaii, Puerto Rico, Guam, the Commonwealth of Northern Mariana Islands, or the U.S. Virgin Islands from which ships, vessels, other surface craft, or aircraft leave for ports in any other State shall post, and keep posted at all times, in one or more conspicuous places in passenger waiting rooms on or in said dock, harbor, or landing field a warning notice directing attention to the quarantine and regulations in this subpart. Every master, or other responsible officer of any ship, vessel, other surface craft, or aircraft leaving Hawaii, Puerto Rico, Guam, the Commonwealth of the Northern Mariana Islands, or the U.S. Virgin Islands destined to a port in any other State, shall similarly post, and keep posted at all times, such a warning notice in the ship, vessel, other surface craft, or aircraft under his charge." 7:7:5.1.1.1.5.1.19.12,7,Agriculture,III,,318,PART 318—STATE OF HAWAII AND TERRITORIES QUARANTINE NOTICES,A,Subpart A—Regulated Articles From Hawaii and the Territories,,§ 318.13-12 Movement by the U.S. Department of Agriculture.,APHIS,,,,"Notwithstanding any other restrictions of this subpart, regulated articles may be moved if they are moved by the U.S. Department of Agriculture for experimental or scientific purposes and are moved under conditions found by the Administrator to be adequate to prevent the spread of plant pests and diseases." 7:7:5.1.1.1.5.1.19.13,7,Agriculture,III,,318,PART 318—STATE OF HAWAII AND TERRITORIES QUARANTINE NOTICES,A,Subpart A—Regulated Articles From Hawaii and the Territories,,§ 318.13-13 Movement of frozen fruits and vegetables.,APHIS,,,"[74 FR 2775, Jan 16, 2009, as amended at 83 FR 46638, Sept. 14, 2018]","Frozen fruits and vegetables may be certified for movement from Hawaii, Puerto Rico, Guam, the Commonwealth of the Northern Mariana Islands, or the U.S. Virgin Islands, into or through any other territory, State, or District of the United States in accordance with § 318.13-3. Such fruits and vegetables must be held at a temperature not higher than 20 °F during shipping and upon arrival in the continental United States, and in accordance with the requirements for the interstate movement of frozen fruits and vegetables in part 305 of this chapter." 7:7:5.1.1.1.5.1.19.14,7,Agriculture,III,,318,PART 318—STATE OF HAWAII AND TERRITORIES QUARANTINE NOTICES,A,Subpart A—Regulated Articles From Hawaii and the Territories,,"§ 318.13-14 Movement of processed fruits, vegetables, and other products.",APHIS,,,,"(a) Fruits, vegetables, and other products that are processed sufficiently as to preclude the survival of any live pests can be moved interstate from Hawaii, Puerto Rico, the U.S. Virgin Islands, Guam, and the Commonwealth of the Northern Mariana Islands. Those processed products which are approved for interstate movement from those States can be found in the fruits and vegetables manuals for those States. These manuals are available on the Internet at http://www.aphis.usda.gov/import_export/plants/manuals/ports/downloads/hawaii.pdf and http://www.aphis.usda.gov/import_export/plants/manuals/ports/downloads/puerto_rico.pdf. (b) Consignments of processed fruits, vegetables, or other products that have not been processed sufficiently as to be incapable of harboring fruit flies are subject to the interstate movement requirements which apply to the fruit, vegetable, or other product in its unprocessed state." 7:7:5.1.1.1.5.1.19.15,7,Agriculture,III,,318,PART 318—STATE OF HAWAII AND TERRITORIES QUARANTINE NOTICES,A,Subpart A—Regulated Articles From Hawaii and the Territories,,§ 318.13-15 Parcel post inspection.,APHIS,,,,"Inspectors are authorized to inspect, with the cooperation of the U.S. Postal Service, parcel post packages placed in the mails in Hawaii, Puerto Rico, Guam, the Commonwealth of the Northern Mariana Islands, or the U.S. Virgin Islands to determine whether such packages contain products whose movement is not authorized under this subpart, to examine any such products that are found for insect infestation, and to notify the postmaster in writing of any violations of this subpart that are found as a result of an inspection." 7:7:5.1.1.1.5.1.19.16,7,Agriculture,III,,318,PART 318—STATE OF HAWAII AND TERRITORIES QUARANTINE NOTICES,A,Subpart A—Regulated Articles From Hawaii and the Territories,,§ 318.13-16 Regulated articles from Guam.,APHIS,,,"[74 FR 2775, Jan 16, 2009. Redeisgnated and amended at 83 FR 46638, Sept. 14, 2018]","(a)(1) Regulated articles, other than soil, may be moved from Guam into or through any other State only if they meet the strictest plant quarantine requirements in accordance with part 319 of this chapter for similar articles offered for entry into such States from the countries of East and Southeast Asia, including Cambodia, India, Japan, Korea, Laos, the northeastern provinces of Manchuria, the Philippines, Taiwan, and Vietnam, or the islands of the Central and South Pacific, including Micronesia, Melanesia, and Polynesia, as well as Australia, New Zealand, and the Malay Archipelago, except requirements for permits, phytosanitary certificates, notices of arrival, and notices of consignment from port of arrival. Soil must meet the requirements of § 330.300 of this chapter. (2) Regulated articles that do not meet the requirements of paragraph (a)(1) of this section are prohibited movement from Guam into or through any other State. (b)(1) Regulated articles moved from Guam into or through any other State shall be subject to inspection at the port of first arrival in another part of the United States to determine whether they are free of plant pests and otherwise meet the requirements applicable to them under this subpart, and shall be subject to release, in accordance with § 330.105(a) of this chapter as if they were foreign arrivals. Such articles shall be released only if they meet all applicable requirements under this subpart. (2) A release shall be issued in writing unless the inspection involves small quantities of regulated articles, in which case a release may be issued orally by the inspector." 7:7:5.1.1.1.5.1.19.17,7,Agriculture,III,,318,PART 318—STATE OF HAWAII AND TERRITORIES QUARANTINE NOTICES,A,Subpart A—Regulated Articles From Hawaii and the Territories,,§ 318.13-17 Cut flowers from Hawaii.,APHIS,,,"[74 FR 2775, Jan 16, 2009. Redesignated at 83 FR 46638, Sept. 14, 2018]","(a) Except for cut blooms and leis of mauna loa and jade vine and except for cut blooms of gardenia not grown in accordance with paragraph (b) of this section, cut flowers may be moved interstate from Hawaii under limited permit, to a destination specified in the permit, directly from an establishment operated in accordance with the terms of a compliance agreement executed by the operator of the establishment, if the articles have not been exposed to infestation and they are not accompanied by any articles prohibited interstate movement under this subpart. (b) Cut blooms of gardenia may be moved interstate from Hawaii if grown and inspected in accordance with the provisions of this section. 4 4 Cut blooms of gardenia are also eligible for interstate movement with treatment in accordance with part 305 of this chapter. (1) The grower's production area must be inspected annually by an inspector and found free of green scale. If green scale is found during an inspection, a 2-month ban will be placed on the interstate movement of cut blooms of gardenia from that production area. Near the end of the 2 months, an inspector will reinspect the grower's production area to determine whether green scale is present. If reinspection determines that the production area is free of green scale, shipping may resume. If reinspection determines that green scale is still present in the production area, another 2-month ban on shipping will be placed on the interstate movement of gardenia from that production area. Each ban will be followed by reinspection in the manner specified, and the production area must be found free of green scale prior to interstate movement. (2) The grower must establish a buffer area surrounding gardenia production areas. The buffer area must extend 20 feet from the edge of the production area. Within the buffer area, the growing of gardenias and the following green scale host plants is prohibited: Ixora, ginger ( Alpinia purpurata ), plumeria, coffee, rambutan, litchi, guava, citrus, anthurium, avocado, banana, cocoa, macadamia, celery, Pluchea indica, mango, orchids, and annona. (3) An inspector must visually inspect the cut blooms of gardenias in each consignment prior to interstate movement from Hawaii to the mainland United States. If the inspector does not detect green scale in the consignment, the inspector will certify the consignment in accordance with § 318.13-3(b). If the inspector finds green scale in a consignment, that consignment will be ineligible for interstate movement from Hawaii." 7:7:5.1.1.1.5.1.19.2,7,Agriculture,III,,318,PART 318—STATE OF HAWAII AND TERRITORIES QUARANTINE NOTICES,A,Subpart A—Regulated Articles From Hawaii and the Territories,,§ 318.13-2 Definitions.,APHIS,,,"[74 FR 2775, Jan 16, 2009, as amended at 83 FR 46637, Sept. 14, 2018]","Administrator. The Administrator of the Animal and Plant Health Inspection Service (APHIS), U.S. Department of Agriculture, or any other employee of APHIS to whom authority has been delegated to act in the Administrator's stead. Animal and Plant Health Inspection Service. The Animal and Plant Health Inspection Service (APHIS) of the U.S. Department of Agriculture. Certification (certified). A type of authorization, issued by an inspector, evidencing freedom from infestation, to allow the movement of certain regulated articles in accordance with the regulations in this subpart. “Certified” shall be construed accordingly. Commercial consignment. A lot of fruits or vegetables that an inspector identifies as having been produced for sale or distribution in mass markets. Such identification will be based on a variety of indicators, including, but not limited to: Quantity of produce, type of packaging, identification of grower and packinghouse on the packaging, and documents consigning the fruits or vegetables to a wholesaler or retailer. Compliance agreement. Any agreement to comply with stipulated conditions as prescribed under § 318.13-3 or § 318.13-4 or § 305.34 of this chapter, executed by any person to facilitate the interstate movement of regulated articles under this subpart. Consignment. A quantity of plants, plant products, and/or other articles, including fruits or vegetables, being moved from one country to another and covered, when required, by a single certificate or limited permit (a consignment may be composed of one or more commodities or lots). Continental United States. The 48 contiguous States, Alaska, and the District of Columbia. Cut flower. Any cut blooms, fresh foliage, and dried decorative plant material customarily used in the florist trade and not for planting; and being the severed portion of a plant, including the inflorescence, and any parts of the plant attached thereto, in a fresh state. Disinfection (disinfect and disinfected). The application to parts or all of a ship, vessel, other surface craft, or aircraft of a treatment that may be designated by the inspector as effective against such plant pests as may be present. (“Disinfect” and “disinfected” shall be construed accordingly.) Fruits and vegetables. A commodity class for fresh parts of plants intended for consumption or processing and not planting. Inspector. A State agricultural inspector or 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 subpart. Interstate. From one State into or through any other State; or within the District of Columbia, Guam, the Virgin Islands of the United States, or any other territory or possession of the United States. Limited permit. A document issued by an inspector or a person operating under a compliance agreement for the interstate movement of regulated articles to a specified destination for: (1) Consumption, limited utilization or processing, or treatment; or (2) Movement into or through the continental United States in conformity with a transit permit. Lot. A number of units of a single commodity, identifiable by its homogeneity of composition and origin, forming all or part of a consignment. Means of conveyance. A ship, truck, aircraft, or railcar. Moved (move and movement). Shipped, offered for shipment to a common carrier, received for transportation or transported by a common carrier, or carried, transported, moved, or allowed to be moved, directly or indirectly, from Hawaii, Puerto Rico, Guam, the Commonwealth of the Northern Marina Islands, or the U.S. Virgin Islands into or through the continental United States or any other State or territory of the United States (or from or into or through other places as specified in this subpart). “Move” and “movement” shall be construed accordingly. Packing materials. Any plant or plant product, soil, or other substance associated with or accompanying any commodity or consignment to serve for filling, wrapping, ties, lining, mats, moisture retention, protection, or any other auxiliary purpose. The word “packing,” as used in the expression “packing materials,” includes the presence of such materials within, in contact with, or accompanying a consignment. Person. Any individual, partnership, corporation, association, joint venture, or other legal entity. Plant debris. Detached leaves, twigs, or other portions of plants, or plant litter or rubbish as distinguished from approved parts of clean fruits and vegetables, or other commercial articles. Plant pests. Any living stage of any of the following that can directly or indirectly injure, cause damage to, or cause disease in any plant or plant product: A protozoan, nonhuman animal, parasitic plant, bacterium, fungus, virus or viroid, infectious agent or other pathogen, or any article similar to or allied with any of those articles. Plant Protection and Quarantine (PPQ). The Plant Protection and Quarantine program of APHIS. Regulated articles. Fruits or vegetables in the raw or unprocessed state; cut flowers; seeds; and plants or plant products for nonpropagative or propagative use. Sealed (sealable) container. A completely enclosed container designed for the storage and/or transportation of commercial air, sea, rail, or truck cargo, and constructed of metal or fiberglass, or other similarly sturdy and impenetrable material, providing an enclosure accessed through doors that are closed and secured with a lock or seal. Sealed (sealable) containers used for sea consignments are distinct and separable from the means of conveyance carrying them when arriving in and in transit through the continental United States. Sealed (sealable) containers used for air consigments are distinct and separable from the means of conveyance carrying them before any transloading in the continental United States. Sealed (sealable) containers used for air consignments after transloading in the continental United States or for overland consignments in the continental United States may either be distinct and separable from the means of conveyance carrying them, or be the means of conveyance itself. Soil. The loose surface material of the earth in which plants grow, in most cases consisting of disintegrated rock with an admixture of organic material and soluble salts. State. Any of the several States of the United States, the Commonwealth of the Northern Mariana Islands, the Commonwealth of Puerto Rico, the District of Columbia, Guam, the Virgin Islands of the United States, or any other territory or possession of the United States. Transit permit. A written authorization issued by the Administrator for the movement of fruits and vegetables en route to a foreign destination that are otherwise prohibited movement by this subpart into the continental United States. Transit permits authorize one or more consignments over a designated period of time. Transloading. The transfer of cargo from one sealable container to another, from one means of conveyance to another, or from a sealable container directly into a means of conveyance. United States. All of the States." 7:7:5.1.1.1.5.1.19.3,7,Agriculture,III,,318,PART 318—STATE OF HAWAII AND TERRITORIES QUARANTINE NOTICES,A,Subpart A—Regulated Articles From Hawaii and the Territories,,§ 318.13-3 General requirements for all regulated articles.,APHIS,,,"[74 FR 2775, Jan. 16, 2009, as amended at 75 FR 4249, Jan. 26, 2010]","All regulated articles that are allowed movement under this subpart must be moved in accordance with the following requirements, except as specifically provided otherwise in this subpart. (a) Freedom from plant debris. All regulated articles moved under this subpart must be free from plant debris. (b) Certification. Certification may be issued for the movement of regulated articles under the following conditions: (1) Certification on basis of inspection or nature of lot involved. Regulated articles may be certified when they have been inspected by an inspector and found apparently free from infestation and infection, or without such inspection when the inspector determines that the lot for consignment is of such a nature that no danger of infestation or infection is involved. (i) Persons intending to move any articles that may be certified must contact the local Plant Protection and Quarantine office as far as possible in advance of the contemplated date of shipment in order to request an inspection. (ii) Persons intending to move any articles that may be certified must prepare, handle, and safeguard such articles from infestation or reinfestation, and assemble them at such points as the inspector may designate, placing them so that inspection may be readily made. (2) Certification on basis of treatment. (i) Regulated articles for which treatments are approved underpart 305 of this chapter may be certified if such treatments have been applied in accordance with part 305 of this chapter and if the articles were handled after such treatment in accordance with a compliance agreement executed by the applicant for certification or under the supervision of an inspector. (ii) Regulated articles certified after treatment in accordance with part 305 of this chapter that are taken aboard any ship, vessel, other surface craft, or aircraft must be segregated and protected in a manner as required by the inspector. (c) Limited permits. (1) Limited permits 1 may be issued by an inspector for the movement of certain noncertified regulated articles to restricted destinations. 1 Limited permits can be obtained from each State or territory's local Plant Protection and Quarantine office. (2) Limited permits may be issued by an inspector for the movement of regulated articles that would otherwise be prohibited movement under this subpart, if the articles are to be moved in accordance with § 318.13-6. (3) Except when the regulations specify that an inspector must issue the limited permit, limited permits may be issued by a person operating under a compliance agreement. (d) Compliance agreements. As a condition for the movement of regulated articles for which a compliance agreement is required, the person entering the compliance agreement must agree to the following: (1) That he or she will use any permit or certification issued to him or her in accordance with the provisions in the permit, the requirements in this subpart, and the compliance agreement; (2) That he or she will maintain at his or her establishment such safeguards against the establishment and spread of infestation and infection and comply with such conditions as to the maintenance of identity, handling (including post-treatment handling), and interstate movement of regulated articles and the cleaning and treatment of means of conveyance and containers used in such movement of the articles, as may be required by the inspector in each specific case to prevent the spread of infestation or infection; and (3) That he or she will allow inspectors to inspect the establishment and its operations. (e) Attachment of limited permit or verification of certification. Except as otherwise provided for certain air cargo and containerized cargo on ships moved in accordance with § 318.13-10, each box, bale, crate, or other container of regulated articles moved under certification or limited permit shall have the limited permit attached to the outside of the container or bear a U.S. Department of Agriculture stamp or inspection sticker verifying that the consignment has been certified in accordance with paragraph (b) of this section: Provided , That if a limited permit or certification is issued for a consignment of more than one container or for bulk products, certification shall be stamped on or the limited permit shall be attached to the accompanying waybill, manifest, or bill of lading. (f) Withdrawal of certification, transit permits, limited permits, or compliance agreements. Any certification, transit permit, limited permit, or compliance agreement which has been issued or authorized may be withdrawn by an inspector orally or in writing, if such inspector determines that the holder thereof has not complied with all conditions under the regulations for the use of such document. If the cancellation is oral, the decision and the reasons for the withdrawal shall be confirmed in writing as promptly as circumstances allow. Any person whose certification, transit permit, limited permit, or compliance agreement 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 shall state all of the facts and reasons upon which the person relies to show that the certification, transit permit, limited permit, or compliance agreement was wrongfully withdrawn. The Administrator shall grant or deny the appeal, in writing, stating the reasons for such decision, as promptly as circumstances allow. If there is a conflict as to any material fact, a hearing shall be held to resolve such conflict. Rules of practice concerning such a hearing will be adopted by the Administrator. (g) Container marking and identity. Except as provided in § 318.13-6(c), consignments of regulated articles moved in accordance with this subpart must have the following information clearly marked on each container or on the waybill, manifest, or bill of lading accompanying the articles: Nature and quantity of contents; name and address of shipper, owner, or person shipping or forwarding the articles; name and address of consignee; shipper's identifying mark and number; and the certification stamp or number of the limited permit authorizing movement, if one was issued. (h) Refusal of movement. An inspector may refuse to allow the interstate movement of a regulated article if the inspector finds that the regulated article is prohibited, is not accompanied by required documentation, is so infested with a plant pest or noxious weed that, in the judgment of the inspector, it cannot be cleaned or treated, or contains soil or other prohibited contaminants. (i) Costs and charges. Services of the inspector during regularly assigned hours of duty at the usual places of duty shall be furnished without cost to the one requesting such services. APHIS will not assume responsibility for any costs or charges, other than those indicated in this section, in connection with the inspection, treatment, conditioning, storage, forwarding, or any other operation of any character incidental to the physical movement of regulated articles or plant pests. (j) APHIS not responsible for damage. APHIS assumes no responsibility for any damage to regulated articles that results from the application of treatment or other measures required under this subpart (or under part 305 of this chapter) to protect against the dissemination of plant pests within the United States." 7:7:5.1.1.1.5.1.19.4,7,Agriculture,III,,318,PART 318—STATE OF HAWAII AND TERRITORIES QUARANTINE NOTICES,A,Subpart A—Regulated Articles From Hawaii and the Territories,,§ 318.13-4 Authorization of certain fruits and vegetables for interstate movement.,APHIS,,,"[83 FR 46637, Sept. 14, 2018]","(a) Determination by the Administrator. No fruit or vegetable is authorized for interstate movement from Hawaii or the territories unless the Administrator has determined that the risk posed by each quarantine pest associated with the fruit or vegetable can be reasonably mitigated by the application of one or more phytosanitary measures designated by the Administrator. (b) Designated phytosanitary measures. (1) The fruits and vegetables are subject to phytosanitary treatments, which could include, but are not limited to, pest control treatments in the field or growing site, and post-harvest treatments. (2) The fruits and vegetables are subject to growing area pest mitigations, which could include, but are not limited to, detection surveys, trapping requirements, pest exclusionary structures, and field inspections. (3) The fruits and vegetables are subject to safeguarding and movement mitigations, which could include, but are not limited to, safeguarded transport, box labeling, limited distribution, insect-proof boxes, and importation as commercial consignments only. (4) The fruits and vegetables are subject to administrative mitigations, which could include, but are not limited to, registered fields or orchards, registered growing sites, registered packinghouses, inspection in the State of origin by an inspector, and operational workplan monitoring. (5) The fruits and vegetables are subject to any other measures deemed appropriate by the Administrator. (c) Authorized fruits and vegetables —(1) Comprehensive list. The name and origin of all fruits and vegetables authorized for interstate movement under this section, as well as the applicable requirements for their movement, may be found on the internet at https://www.aphis.usda.gov/aphis/ourfocus/planthealth/complete-list-of-electronic-manuals. (2) Fruits and vegetables authorized for interstate movement prior to October 15, 2018. Fruits and vegetables that were authorized for interstate movement under this subpart as of October 15, 2018 may continue to be moved interstate under the same requirements that applied before October 15, 2018, except as provided in paragraph (c)(4) of this section. (3) Other fruits and vegetables. Fruits and vegetables not already authorized for interstate movement as described in paragraph (c)(2) of this section may be authorized for interstate movement only after: (i) APHIS has analyzed the pest risk posed by the interstate movement of a fruit or vegetable and has determined that the risk posed by each quarantine pest associated with the fruit or vegetable can be reasonably mitigated by the application of one or more phytosanitary measures; (ii) APHIS has made its pest risk analysis and determination available for public comment for at least 60 days through a notice published in the Federal Register ; and (iii) The Administrator has announced his or her decision in a subsequent Federal Register notice to begin allowing interstate movement of the fruit or vegetable subject to the phytosanitary measures specified in the notice. (4) Changes to phytosanitary measures. (i) If the Administrator determines that the phytosanitary measures required for a fruit or vegetable that has been authorized interstate movement under this subpart are no longer sufficient to reasonably mitigate the pest risk posed by the fruit or vegetable, APHIS will prohibit or further restrict interstate movement of the fruit or vegetable. APHIS will also publish a notice in the Federal Register advising the public of its finding. The notice will specify the amended interstate movement requirements, provide an effective date for the change, and invite public comment on the subject. (ii) If the Administrator determines that any of the phytosanitary measures required for a fruit or vegetable that has been authorized interstate movement under this subpart are no longer necessary to reasonably mitigate the pest risk posed by the fruit or vegetable, APHIS will make new pest risk documentation available for public comment, in accordance with paragraph (c)(3) of this section, prior to allowing interstate movement of the fruit or vegetable subject to the phytosanitary measures specified in the notice." 7:7:5.1.1.1.5.1.19.5,7,Agriculture,III,,318,PART 318—STATE OF HAWAII AND TERRITORIES QUARANTINE NOTICES,A,Subpart A—Regulated Articles From Hawaii and the Territories,,§ 318.13-5 Pest-free areas.,APHIS,,,,"Certain fruits or vegetables may be moved interstate provided that the fruits or vegetables originate from an area that is free of a specific pest or pests. In some cases, fruits or vegetables may only be moved interstate if the area of origin is free of all plant pests that attack the fruits or vegetables. In other cases, fruits or vegetables may be moved interstate if the area of origin is free of one or more plant pests that attack the fruit or vegetable and the risk posed by the remaining plant pests that attack the fruit or vegetable is mitigated by other specific phytosanitary measures contained in the regulations in this subpart. (a) Application of standards for pest-free areas. APHIS will make a determination of an area's pest-free status based on information provided by the State. The information used to make this determination will include trapping and surveillance data, survey protocols, and protocols for actions to be performed upon detection of a pest. (b) Survey protocols. APHIS must approve the survey protocol used to determine and maintain pest-free status, as well as protocols for actions to be performed upon detection of a pest. Pest-free areas are subject to audit by APHIS to verify their status. (c) Determination of pest freedom. (1) For an area to be considered free of a specified pest for the purposes of this subpart, the Administrator must determine, and announce in a notice published in the Federal Register for a public comment period of 60 days, that the area meets the criteria of paragraphs (a) and (b) of this section. (2) The Administrator will announce his or her decision in a subsequent Federal Register notice. If appropriate, APHIS will allow movement of the regulated article from a pest-free area because: (i) No comments were received on the notice or (ii) The comments on the notice did not affect the overall conclusions of the notice and the Administrator's determination of risk. (d) Decertification of pest-free areas; reinstatement. If a pest is detected in an area that is designated as free of that pest, APHIS will publish in the Federal Register a notice announcing that the pest-free status of the area in question has been withdrawn and that interstate movement of host crops for the pest in question is subject to application of an approved treatment for the pest. If a treatment for the pest is not available, interstate movement of the host crops would be prohibited. In order for a decertified pest-free area to be reinstated, it would have to meet the criteria of paragraphs (a) through (c) of this section. (e) General requirements for the interstate movement of regulated articles from pest-free areas —(1) Labeling. Each box of fruits or vegetables that is moved interstate from a pest-free area under this subpart must be clearly labeled with: (i) The name of the orchard or grove of origin, or the name of the grower; and (ii) The name of the municipality and State or territory in which the fruits or vegetables were produced; and (iii) The type and amount of fruits or vegetables the box contains. (2) Compliance agreement. Persons wishing to move fruits or vegetables from a pest-free area in Hawaii, Puerto Rico, Guam, the Commonwealth of the Northern Mariana Islands, or the U.S. Virgin Islands must enter into a compliance agreement with APHIS in accordance with § 318.13-3(d). (3) Safeguarding. If fruits or vegetables are moved from a pest-free area into or through an area that is not free of that pest, the fruits or vegetables must be safeguarded during the time they are present in a non-pest-free area by being covered with insect-proof mesh screens or plastic tarpaulins, including while in transit to the packinghouse and while awaiting packaging. If fruits or vegetables are moved through an area that is not free of that pest during transit to a port, they must be packed in insect-proof cartons or containers or be covered by insect-proof mesh or plastic tarpaulins during transit to the port and subsequent movement into or through the United States. These safeguards described in this section must remain intact until the fruits or vegetables reach their final destination." 7:7:5.1.1.1.5.1.19.6,7,Agriculture,III,,318,PART 318—STATE OF HAWAII AND TERRITORIES QUARANTINE NOTICES,A,Subpart A—Regulated Articles From Hawaii and the Territories,,§ 318.13-6 Transit of fruits and vegetables from Hawaii or the territories into or through the continental United States.,APHIS,,,"[74 FR 2775, Jan 16, 2009, as amended at 84 FR 2428, Feb. 7, 2019]","Fruits and vegetables from Hawaii, Puerto Rico, Guam, the Commonwealth of the Northern Mariana Islands, or the U.S. Virgin Islands that are otherwise prohibited interstate movement into the continental United States by this subpart may transit the continental United States en route to a foreign destination when moved in accordance with this section. (a) Transit permit. (1) A transit permit is required for the arrival, unloading, and movement through the continental United States of fruits and vegetables otherwise prohibited by this subpart from being moved through the continental United States from Hawaii, Puerto Rico, Guam, the Commonwealth of the Northern Mariana Islands, or the U.S. Virgin Islands. Application for a transit permit may be made in writing or with PPQ Form 586. 2 The transit permit application must include the following information: 2 PPQ Form 586 can be obtained from PPQ Permit Services or at http://www.aphis.usda.gov/plant_health/permits/transit.shtml . Applications for transit permits should be submitted to USDA, APHIS, PPQ Permit Services, 4700 River Road Unit 136, Riverdale, MD 20737 or through e-permits http://www.aphis.usda.gov/permits/learn_epermits.shtml. (i) The specific types of fruits and vegetables to be shipped (only scientific or English common names are acceptable); (ii) The means of conveyance to be used to transport the fruit or vegetable through the continental United States; (iii) The port of arrival in the continental United States, and the location of any subsequent stop; (iv) The location of, and the time needed for, any storage in the continental United States; (v) Any location in the continental United States where the fruits or vegetables are to be transloaded; (vi) The means of conveyance to be used for transporting the fruits or vegetables from the port of arrival in the continental United States to the port of export; (vii) The estimated time necessary to accomplish exportation, from arrival at the port of arrival in the continental United States to exit at the port of export; (viii) The port of export; and (ix) The name and address of the applicant and, if the applicant's address is not within the territorial limits of the continental United States, the name and address in the continental United States of an agent whom the applicant names for acceptance of service of process. (2) A transit permit will be issued only if the following conditions are met: (i) APHIS inspectors are available at the port of arrival, port of export, and any locations at which transloading of cargo will take place and, in the case of air consignments, at any interim stop in the continental United States, as indicated on the application for the transit permit; (ii) The application indicates that the proposed movement would comply with the provisions in this section applicable to the transit permit; and (iii) During the 12 months prior to receipt of the application by APHIS, the applicant has not had a transit permit withdrawn under § 318.13-3(f), unless the transit permit has been reinstated upon appeal. (b) Limited permit. Fruits or vegetables shipped from Hawaii, Puerto Rico, Guam, the Commonwealth of the Northern Mariana Islands, or the U.S. Virgin Islands through the continental United States under this section must be accompanied by a limited permit, a copy of which must be presented to an inspector at the port of arrival and the port of export in the continental United States, and at any other location in the continental United States where an air consignment is authorized to stop or where overland consignments change means of conveyance. An inspector will issue a limited permit if the following conditions are met: (1) The inspector determines that the specific type and quantity of the fruits or vegetables being shipped are accurately described by accompanying documentation, such as the accompanying manifest, waybill, and bill of lading. (Only scientific or English common names are acceptable.) The fruits or vegetables shall be assembled at whatever point and in whatever manner the inspector designates as necessary to comply with the requirements of this section; and (2) The inspector establishes that the consignment of fruits or vegetables has been prepared in compliance with the provisions of this section. (c) Marking requirements. Each of the smallest units, including each of the smallest bags, crates, or cartons, containing regulated articles for transit through the continental United States under this section must be conspicuously marked, prior to the locking and sealing of the container in the State of origin, with a printed label that includes a description of the specific type and quantity of the fruits or vegetables (only scientific or English common names are acceptable), the transit permit number under which the regulated articles are to be shipped, and, in English, the State in which they were grown and the statement “Distribution in the United States is Prohibited.” (d) Handling of fruits and vegetables. Fruits or vegetables shipped through the United States from Hawaii, Puerto Rico, Guam, the Commonwealth of the Northern Mariana Islands, or the U.S. Virgin Islands in accordance with this section may not be commingled in the same sealed container with fruits or vegetables that are intended for entry and distribution in the United States. The fruits or vegetables must be kept in sealed containers from the time the limited permit required by paragraph (b) of this section is issued, until the fruits or vegetables exit the United States, except as otherwise provided in the regulations in this section. Transloading must be carried out in accordance with the requirements of paragraphs (a), (h), and (i) of this section. (e) Area of movement. The port of arrival, the port of export, ports for air stops, and overland movement within the continental United States of fruits or vegetables shipped under this section is limited to a corridor that includes all States of the continental United States except Alabama, Arizona, California, Florida, Georgia, Kentucky, Louisiana, Mississippi, Nevada, New Mexico, North Carolina, South Carolina, Tennessee, Texas, and Virginia, except that movement is allowed through Dallas/Fort Worth, TX, as an authorized stop for air cargo, or as a transloading location for consignments that arrive by air but that are subsequently transloaded into trucks for overland movement from Dallas/Fort Worth, TX, into the designated corridor by the shortest route. Movement through the United States must begin and end at locations staffed by APHIS inspectors. (f) Movement of regulated articles. Transportation through the continental United States shall be by the most direct route to the final destination of the consignment in the country to which it is exported, as determined by APHIS based on commercial shipping routes and timetables and set forth in the transit permit. No change in the quantity of the original consignment from that described in the limited permit is allowed. No remarking is allowed. No diversion or delay of the consignment from the itinerary described in the transit permit and limited permit is allowed unless authorized by an APHIS inspector upon determination by the inspector that the change will not significantly increase the risk of plant pests or diseases in the United States, and unless each port to which the consignment is diverted is staffed by APHIS inspectors. (g) Notification in case of emergency. In the case of an emergency such as an accident, a mechanical breakdown of the means of conveyance, or an unavoidable deviation from the prescribed route, the person in charge of the means of conveyance must, as soon as practicable, notify the APHIS office at the port where the cargo arrived in the United States. (h) Consignments by sea. Except as authorized by this paragraph, consignments arriving in the United States by sea from Hawaii, Puerto Rico, Guam, the Commonwealth of the Northern Mariana Islands, or the U.S. Virgin Islands may be transloaded once from a ship to another ship or, alternatively, once to a truck or railcar at the port of arrival and once from a truck or railcar to a ship at the port of export, and must remain in the original sealed container, except under extenuating circumstances and when authorized by an inspector upon determination by the inspector that the transloading would not significantly increase the risk of the introduction of plant pests or diseases into the United States, and provided that APHIS inspectors are available to provide supervision. No other transloading of the consignment is allowed, except under extenuating circumstances ( e.g. , equipment breakdown) and when authorized by an inspector upon determination by the inspector that the transloading would not significantly increase the risk of the introduction of plant pests or diseases into the continental United States, and provided that APHIS inspectors are available to provide supervision. (i) Consignments by air. (1) Consignments arriving in the United States by air from Hawaii, Puerto Rico, Guam, the Commonwealth of the Northern Mariana Islands, or the U.S. Virgin Islands may be transloaded only once in the United States. Transloading of air consignments must be carried out in the presence of an APHIS inspector. Consignments arriving by air that are transloaded may be transloaded either into another aircraft or into a truck trailer for export by the most direct route to the final destination of the consignment through the designated corridor set forth in paragraph (e) of this section. This may be done at either the port of arrival in the United States or at the second air stop within the designated corridor, as authorized in the transit permit and as provided in paragraph (i)(2) of this section. No other transloading of the consignment is allowed, except under extenuating circumstances ( e.g. , equipment breakdown) and when authorized by an APHIS inspector upon determination by the inspector that the transloading would not significantly increase the risk of the introduction of plant pests or diseases into the United States, and provided that APHIS inspectors are available to provide supervision. Transloading of air consignments will be authorized only if the following conditions are met: (i) The transloading is done into sealable containers; (ii) The transloading is carried out within the secure area of the airport ( i.e. , that area of the airport that is open only to personnel authorized by the airport security authorities); (iii) The area used for any storage is within the secure area of the airport; and (iv) APHIS inspectors are available to provide the supervision required by paragraph (i)(1) of this section. (2) Except as authorized by paragraph (f) of this section, consignments that continue by air from the port of arrival in the continental United States may be authorized by APHIS for only one additional stop in the continental United States, provided the second stop is within the designated corridor set forth in paragraph (e) of this section and is staffed by APHIS inspectors. As an alternative to transloading a consignment arriving in the United States into another aircraft, consignments that arrive by air may be transloaded into a truck trailer for export by the most direct route to the final destination of the consignment through the designated corridor set forth in paragraph (e) of this section. This may be done at either the port of arrival in the United States or at the second authorized air stop within the designated corridor. No other transloading of the consignment is allowed, except under extenuating circumstances ( e.g. , equipment breakdown) and when authorized by an APHIS inspector upon determination by the inspector that the transloading would not significantly increase the risk of the introduction of plant pests or diseases into the United States, and provided that APHIS inspectors are available to provide supervision. (j) Duration and location of storage. Any storage in the United States of fruits or vegetables shipped under this section must be for a duration and in a location authorized in the transit permit required by paragraph (a) of this section. Areas where such fruits or vegetables are stored must be either locked or guarded at all times the fruits and vegetables are present. Cargo shipped under this section must be kept in a sealed container while stored in the continental United States. (k) Temperature requirement. Except for time spent on aircraft and except during storage and transloading of air consignments, the temperature in the sealed containers containing fruits and vegetables moved under this section must be 60 °F or lower from the time the regulated articles leave Hawaii, Puerto Rico, Guam, the Commonwealth of the Northern Mariana Islands, the U.S. Virgin Islands, or any other territory or possession of the United States until they exit the United States. (l) Prohibited materials. (1) The person in charge of or in possession of a sealed container used for movement into or through the United States under this section must ensure that the sealed container is carrying only those fruits or vegetables authorized by the transit permit required under paragraph (a) of this section; and (2) The person in charge of or in possession of any means of conveyance or container returned to the United States without being reloaded after being used to export fruits or vegetables from the United States under this section must ensure that the means of conveyance or container is free of materials prohibited importation into the United States under this chapter. (m) Authorization by APHIS of the movement of fruits or vegetables through the United States under this section does not imply that such fruits or vegetables are enterable into the destination country. Consignments returned to the United States from the destination country shall be subject to all applicable regulations, including “Subpart L—Fruits and Vegetables ” of part 319 and “Plant Quarantine Safeguard Regulations” of part 352 of this chapter. (n) Any restrictions and requirements with respect to the arrival, temporary stay, unloading, transloading, transiting, exportation, or other movement or possession in the United States of any fruits or vegetables under this section shall apply to any person who brings into, maintains, unloads, transloads, transports, exports, or otherwise moves or possesses in the United States such fruits or vegetables, whether or not that person is the one who was required to have a transit permit or limited permit for the fruits or vegetables or is a subsequent custodian of the fruits or vegetables. Failure to comply with all applicable restrictions and requirements under this section by such a person shall be deemed to be a violation of this section." 7:7:5.1.1.1.5.1.19.7,7,Agriculture,III,,318,PART 318—STATE OF HAWAII AND TERRITORIES QUARANTINE NOTICES,A,Subpart A—Regulated Articles From Hawaii and the Territories,,§ 318.13-7 Products as ships' stores or in the possession of passengers or crew.,APHIS,,,,"(a) In the possession of passengers or crew members. Small quantities of fruits, vegetables, or cut flowers subject to the quarantine and regulations in this subpart, when loose and free of packing materials, may be taken aboard any ship, vessel, or other surface craft by passengers or members of the crew without inspection and certification in the State of origin. However, if such articles are not eligible for certification under § 318.13-3, they must be entirely consumed or disposed of before arrival within the territorial waters of the continental United States, Hawaii, Puerto Rico, Guam, the Commonwealth of the Northern Mariana Islands, or the U.S. Virgin Islands. (b) As ships' stores or decorations. Fruits, vegetables, or cut flowers subject to the quarantine and regulations in this subpart may be taken aboard a ship, vessel, or other surface craft in Hawaii, Puerto Rico, Guam, the Commonwealth of the Northern Mariana Islands, or the U.S. Virgin Islands without inspection or certification. Fruits, vegetables, and cut flowers that are so taken aboard such a carrier must be either: (1) Entirely consumed or removed from the ship, vessel, or other surface craft before arrival within the territorial waters of the continental United States, Hawaii, Puerto Rico, Guam, the Commonwealth of the Northern Mariana Islands, the U.S. Virgin Islands, or any other territory or possession of the United States; or (2) In the case of a surface carrier, retained aboard such carrier under seal or otherwise disposed of subject to safeguards equivalent to those imposed on other prohibited or restricted products by paragraphs (b) and (c) of § 352.10 of this chapter." 7:7:5.1.1.1.5.1.19.8,7,Agriculture,III,,318,PART 318—STATE OF HAWAII AND TERRITORIES QUARANTINE NOTICES,A,Subpart A—Regulated Articles From Hawaii and the Territories,,§ 318.13-8 Articles and persons subject to inspection.,APHIS,,,,"In addition to the inspection requirements in §§ 318.13-9 and 318.13-10, persons, means of conveyance (including ships, other oceangoing craft, and aircraft), baggage, cargo, and any other articles, that are destined for movement, are moving, or have been moved from Hawaii, Puerto Rico, Guam, the Commonwealth of the Northern Mariana Islands, or the U.S. Virgin Islands to a destination elsewhere in the United States are subject to agricultural inspection at the port of departure, the port of arrival, or any other authorized port. If an inspector finds any article prohibited movement by the quarantine and regulations of this subpart, he or she, taking the least drastic action, shall order the return of the article to the place of origin, or the exportation of the article, under safeguards satisfactory to him or her, or otherwise dispose of it, in whole or part, to comply with the quarantine and regulations of this subpart." 7:7:5.1.1.1.5.1.19.9,7,Agriculture,III,,318,PART 318—STATE OF HAWAII AND TERRITORIES QUARANTINE NOTICES,A,Subpart A—Regulated Articles From Hawaii and the Territories,,§ 318.13-9 Inspection and disinfection of means of conveyance.,APHIS,,,,"(a) Inspection of aircraft prior to departure. No person shall move any aircraft from Hawaii, Puerto Rico, Guam, the Commonwealth of the Northern Mariana Islands, or the U.S. Virgin Islands to any other State unless the person moving the aircraft has contacted an inspector and offered the inspector the opportunity to inspect the aircraft prior to departure and the inspector has informed the person proposing to move the aircraft that the aircraft may depart. (b) Inspection of aircraft moving to Guam. Any person who has moved an aircraft from Hawaii, Puerto Rico, the Commonwealth of the Northern Mariana Islands, or the U.S. Virgin Islands to Guam shall contact an inspector and offer the inspector the opportunity to inspect the aircraft upon the aircraft's arrival in Guam. (c) Inspection of ships upon arrival. Any person who has moved a ship or other oceangoing craft from Hawaii, Puerto Rico, Guam, the Commonwealth of the Northern Mariana Islands, or the U.S. Virgin Islands to any other State shall contact an inspector and offer the inspector the opportunity to inspect the ship or other oceangoing craft upon its arrival. (d) Disinfection of means of conveyance. If an inspector finds that a means of conveyance is infested with or contains plant pests, and the inspector orders disinfection of the means of conveyance, then the person in charge or in possession of the means of conveyance shall disinfect the means of conveyance and its cargo in accordance with an approved method contained in part 305 of this chapter under the supervision of an inspector and in a manner prescribed by the inspector, prior to any movement of the means of conveyance or its cargo." 7:7:5.1.1.1.5.2.19.1,7,Agriculture,III,,318,PART 318—STATE OF HAWAII AND TERRITORIES QUARANTINE NOTICES,B,"Subpart B—Territorial Cotton, Cottonseed, and Cottonseed Products",,§ 318.47 Notice of quarantine.,APHIS,,,"[24 FR 10777, Dec. 29, 1959, as amended at 66 FR 21054, Apr. 27, 2001]","(a) The Secretary of Agriculture having previously quarantined Hawaii and Puerto Rico on account of the pink bollworm of cotton (Pectinophora gossypiella Saunders) and the cotton blister mite (Eriophyes gossypii Banks), insect pests new to and not widely prevalent or distributed within and throughout the United States, now determines that it is necessary to extend the quarantine to prevent the spread of these insects from the Virgin Islands of the United States, where they are known to occur. (b) Under the authority of sections 411, 412, 414, and 434 of the Plant Protection Act (7 U.S.C. 7711, 7712, 7714, and 7754), Hawaii, Puerto Rico, and the Virgin Islands of the United States are quarantined to prevent the spread of the aforementioned insect pests. (c) All parts and products of plants of the genus Gossypium, such as seeds including seed cotton; cottonseed; cotton lint, linters, and other forms of cotton fiber; cottonseed hulls, cake, meal, and other cottonseed products, except oil; cotton waste; and all other unmanufactured parts of cotton plants; and all second-hand burlap and other fabric which have been used, or are of the kinds ordinarily used, for wrapping or containing cotton, are hereby prohibited movement from the Hawaii, Puerto Rico, and the Virgin Islands of the United States into or through any other State, Territory or District of the United States, in manner or method or under conditions other than those prescribed in the regulations hereinafter made or amendments thereto: Provided, That whenever the Deputy Administrator of the Plant Protection and Quarantine Programs shall find that existing conditions as to the pest risk involved in the movement of the articles to which the regulations supplemental hereto apply, make it safe to modify, by making less stringent, the restrictions contained in any such regulations, he shall set forth and publish such findings in administrative instructions, specifying the manner in which the regulations should be made less stringent, whereupon such modification shall become effective. (d) As used in this subpart, unless the context otherwise requires, the term State, Territory, or District of the United States means State, the District of Columbia, Alaska, Guam, Hawaii, Puerto Rico, or the Virgin Islands of the United States." 7:7:5.1.1.1.5.2.19.2,7,Agriculture,III,,318,PART 318—STATE OF HAWAII AND TERRITORIES QUARANTINE NOTICES,B,"Subpart B—Territorial Cotton, Cottonseed, and Cottonseed Products",,§ 318.47a Administrative instructions relating to Guam.,APHIS,,,,"The plants, products and articles specified in § 318.47(c) may be moved from Hawaii into or through Guam without restriction under this subpart." 7:7:5.1.1.1.5.2.21.3,7,Agriculture,III,,318,PART 318—STATE OF HAWAII AND TERRITORIES QUARANTINE NOTICES,B,"Subpart B—Territorial Cotton, Cottonseed, and Cottonseed Products",,§ 318.47-1 Definitions.,APHIS,,,,"For the purpose of the regulations in this subpart the following words, names, and terms shall be construed, respectively, to mean: (a) Cotton. Parts and products of plants of the genus Gossypium, including seed cotton; cottonseed; cotton lint, linters and other forms of cotton fiber; cottonseed hulls, cake, meal, and other cottonseed products, except oil; cotton waste; and all other unmanufactured parts of cotton plants; and second-hand burlap and other fabric which have been used, or are of the kinds ordinarily used, for wrapping or containing cotton. (b) Seed cotton. The unginned lint and seed admixture, just as it is picked from the cotton boll. (c) Cottonseed. The seed of the cotton plant, either separated from the lint or as a component part of seed cotton. (d) Lint. All forms of raw or unmanufactured ginned cotton, either baled or unbaled, including all cotton fiber, except linters, which has not been woven or spun, or otherwise manufactured. (e) Linters. All forms of unmanufactured cotton fiber separated from cottonseed after the lint has been removed, including that form referred to as “hull fiber.” (f) Waste. All forms of cotton waste derived from the manufacture of cotton lint, in any form or under any trade designation, including gin waste; and waste products derived from the milling of cottonseed. (g) Seedy waste. Picker waste, gin waste, and oil mill waste, and any other cotton by-products capable of carrying a high percentage of cottonseed. (h) Clean waste. Wastes derived from the processing of lint in machines after the card machine, including card strips but not card fly. (i) Bale covers. Second-hand burlap and other second-hand fabric by whatever trade designation, which have been used, or are of the kinds ordinarily used, for wrapping or otherwise containing cotton. Burlap and other fabric of the kinds ordinarily used for wrapping cotton, when new or unused, are excluded from this definition. (j) Certificate ( certification, certified ). A type of authorization, evidencing freedom from infestation, issued by the Deputy Administrator of the Plant Protection and Quarantine Programs to allow the movement of lint, linters, waste, seed cotton, cottonseed, cottonseed hulls, cake, and meal, and bale covers in accordance with the regulations in this subpart. “Certification” and “certified” shall be construed accordingly. (k) Permit. A type of general authorization issued by the Deputy Administrator of the Plant Protection and Quarantine Programs to allow the movement of lint, linters, waste other than seedy waste, cottonseed cake and meal, and bale covers in accordance with the regulations in this subpart. (l) Fumigated. Fumigated under the supervision of an inspector of the Plant Protection and Quarantine Programs in a fumigation plant approved by the Deputy Administrator of said Programs and in accordance with methods approved by him. (m) Moved ( movement, move ). Shipped, offered for shipment to a common carrier, received for transportation or transported by a common carrier, or carried, transported, moved, or allowed to be moved, directly or indirectly, from Hawaii, Puerto Rico, or the Virgin Islands of the United States, into or through any other State, Territory, or District of the United States. “Movement” and “move” shall be construed accordingly." 7:7:5.1.1.1.5.2.21.4,7,Agriculture,III,,318,PART 318—STATE OF HAWAII AND TERRITORIES QUARANTINE NOTICES,B,"Subpart B—Territorial Cotton, Cottonseed, and Cottonseed Products",,§ 318.47-2 Articles the movement of which is prohibited or regulated.,APHIS,,,,"(a) Articles prohibited movement. The movement of seed cotton, cottonseed, and seedy waste, when unfumigated, is prohibited except as provided in § 318.47-3(b)(2). (b) Articles the movement of which is regulated. Lint; linters; waste; seed cotton; cottonseed; cottonseed hulls, cake, and meal; and bale covers may be moved upon compliance with the conditions prescribed in § 318.47-3." 7:7:5.1.1.1.5.2.21.5,7,Agriculture,III,,318,PART 318—STATE OF HAWAII AND TERRITORIES QUARANTINE NOTICES,B,"Subpart B—Territorial Cotton, Cottonseed, and Cottonseed Products",,§ 318.47-3 Conditions governing the issuance of certificates and permits.,APHIS,,,"[24 FR 10777, Dec. 29, 1959, as amended at 75 FR 4251, Jan. 26, 2010]","(a) Fumigated lint; linters; waste; seed cotton; cottonseed; cottonseed hulls, cake, and meal; and bale covers. Lint; linters; waste; seed cotton; cottonseed; cottonseed hulls, cake, and meal; and bale covers, fumigated in the Territory or District of origin in accordance with part 305 of this chapter and so certified, are allowed unrestricted movement to any port. (b) Unfumigated lint, linters, waste, and bale covers. (1) Unfumigated Hawaiian, Puerto Rican, or Virgin Islands of the United States lint, linters, waste other than seedy waste, and bale covers will be allowed to move under permit, by all-water route, for entry only at the ports of Norfolk, Baltimore, New York, Boston, San Francisco, and Seattle, or other port of arrival designated in the permit, and at such designated port of arrival shall become subject to the regulations governing the handling of cotton imported from foreign countries. (2) Fumigation may be waived and certificates issued for lint, linters, and waste which have been determined by an inspector of the Plant Protection and Quarantine Programs to have been so manufactured or processed by bleaching, dyeing, or other means, as to have removed all seeds, or to have destroyed all insect life therein. (c) Cottonseed cake and meal. (1) Cottonseed cake and meal which have been inspected in the Territory or District of origin and certified by an inspector of the Plant Protection and Quarantine Programs as being free from contamination with whole, uncrushed cottonseed, will be allowed unrestricted movement to any port. (2) Hawaiian, Puerto Rican, and Virgin Islands of the United States cottonseed cake and meal, when neither fumigated nor inspected in accordance with the provisions of this section, will be allowed entry under permit through any port at which the services of an inspector are available, subject to examination by an inspector for freedom from contamination with uncrushed cottonseed. If found to be free from such contamination, the cottonseed cake or meal may be released from further entry restrictions. Cottonseed cake or meal found to be contaminated shall be refused entry or subjected as a condition of entry and release to such safeguards as may be prescribed by the inspector from such administratively approved methods as will, in his judgment, be necessary to eliminate infestations of the pink bollworm or cotton blister mite." 7:7:5.1.1.1.5.2.21.6,7,Agriculture,III,,318,PART 318—STATE OF HAWAII AND TERRITORIES QUARANTINE NOTICES,B,"Subpart B—Territorial Cotton, Cottonseed, and Cottonseed Products",,§ 318.47-4 Shipments by the Department of Agriculture.,APHIS,,,,"Cotton may be moved by the Department of Agriculture for experimental or scientific purposes under such conditions as may be prescribed by the Deputy Administrator of the Plant Protection and Quarantine Programs, which conditions may include clearance through the New Crops Research Branch of the Plant Science Research Division, Agricultural Research Service." 7:7:5.1.1.1.5.3.21.1,7,Agriculture,III,,318,PART 318—STATE OF HAWAII AND TERRITORIES QUARANTINE NOTICES,C,"Subpart C—Sand, Soil, or Earth, with Plants from Territories and Districts",,§ 318.60 Notice of quarantine.,APHIS,,,"[24 FR 10777, Dec. 29, 1959, as amended at 66 FR 21054, Apr. 27, 2001; 83 FR 11855, Mar. 19, 2018; 84 FR 29957, June 25, 2019]","(a) The Secretary of Agriculture, having previously quarantined Hawaii and Puerto Rico to prevent the spread to other parts of the United States, by means of sand, soil, or earth about the roots of plants, of immature stages of certain dangerous insects, including Phyllophaga spp. (White grubs), Phytalus sp., and Adoretus sp., and of several species of termites or white ants, new to and not heretofore widely prevalent or distributed within and throughout the United States, now determines that it is necessary also to quarantine the Virgin Islands of the United States to prevent the spread of such dangerous insects from said Virgin Islands. (b) Under the authority of sections 411, 412, 414, and 434 of the Plant Protection Act (7 U.S.C. 7711, 7712, 7714, and 7754), Hawaii, Puerto Rico, and the Virgin Islands of the United States are quarantined to prevent the spread of the aforementioned dangerous insects. (c) Sand (other than clean ocean sand), soil, or earth around the roots of plants must not be shipped, offered for shipment to a common carrier, received for transportation or transported by a common carrier, or carried, transported, moved, or allowed to be moved by any person from Hawaii, Puerto Rico, or the Virgin Islands of the United States into or through any other State, Territory, or District of the United States: Provided, That the prohibitions in this paragraph (c) do not apply to the movement of soil from Hawaii, Puerto Rico, and the Virgin Islands other than that soil around the roots of plants; movement of soil that is not around the roots of plants is regulated under part 330 of this chapter: Provided further, That the prohibitions of this section shall not apply to the movement of such products in either direction between Puerto Rico and the Virgin Islands of the United States: Provided further, That such prohibitions shall not prohibit the movement of such products by the United States Department of Agriculture for scientific or experimental purposes, nor prohibit the movement of sand, soil, or earth around the roots of plants which are carried, for ornamental purposes, on vessels into mainland ports of the United States and which are not intended to be landed thereat, when evidence is presented satisfactory to the inspector of the Plant Protection and Quarantine Programs of the Department of Agriculture that such sand, soil, or earth has been so processed or is of such nature that no pest risk is involved, or that the plants with sand, soil, or earth around them are maintained on board under such safeguards as will preclude pest escape: And provided further, That such prohibitions shall not prohibit the movement of plant cuttings or plants that have been— (1) Freed from sand, soil, and earth; (2) Subsequently potted and established in sphagnum moss or other packing material approved under § 319.37-11 of this chapter that had been stored under shelter and had not been previously used for growing or packing plants; (3) Grown thereafter in a manner satisfactory to an inspector of the Plant Protection and Quarantine Programs to prevent infestation through contact with sand, soil, or earth; and (4) Certified by an inspector of the Plant Protection and Quarantine Programs as meeting the requirements of paragraphs (c)(1) through (3) of this section. (d) As used in this section, the term State, Territory, or District of the United States means “Guam, Hawaii, Puerto Rico, the Virgin Islands of the United States, or the continental United States.”" 9:9:2.0.2.1.19.1.7.1,9,Animals and Animal Products,III,A,318,PART 318—ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND PREPARATION OF PRODUCTS,A,Subpart A—General,,§ 318.1 Products and other articles entering official establishments.,FSIS,,,"[35 FR 15586, Oct. 3, 1970, as amended at 36 FR 11639, June 17, 1971; 38 FR 5152, Feb. 26, 1973; 48 FR 6091, Feb. 10, 1983; 49 FR 32055, Aug. 10, 1984; 64 FR 72174, Dec. 23, 1999; 90 FR 27226, June 26, 2025]","(a) Except as otherwise provided in paragraphs (g) and (h) of this section or § 318.12, no product shall be brought into an official establishment unless it has been prepared only in an official establishment and previously inspected and passed by a Program employee, and is identified by an official inspection legend as so inspected and passed. Notwithstanding the foregoing provisions of this subparagraph, product imported in accordance with part 327 of this subchapter and not prepared in the United States outside an official establishment, may enter any official establishment subject in other respects to the same restrictions as apply to domestic product. Products received in an official establishment during the Program employees absence shall be identified and maintained in a manner acceptable to such employee. Product entering any official establishment shall not be used or prepared thereat until it has been reinspected in accordance with § 318.2. Any product originally prepared at any official establishment may not be returned into any part of such establishment, except the receiving area approved under § 318.3, until it has been reinspected by the inspector. (b) No slaughtered poultry or poultry product shall be brought into an official establishment unless it has been (1) previously inspected and passed and is identified as such in accordance with the requirements of the Poultry Products Inspection Act (21 U.S.C. 451 et seq. ) and the regulations thereunder, and has not been prepared other than in an establishment inspected under said Act, or (2) has been inspected and passed and is identified as such in accordance with the requirements of a State law. (c) Every article for use as an ingredient in the preparation of meat food products, when entering any official establishment and at all times while it is in such establishment, shall bear a label showing the name of the article, the amount or percentage therein of any substances restricted by this part or part 317 of this subchapter, and a list of ingredients in the article if composed of two or more ingredients: Provided, That in the case of articles received in tank car lots, only one such label shall be used to identify each lot. In addition, the label must show the name and address of the shipper. (d) To ensure the safe use of preparations used in hog scalding water or in the denuding of tripe, the label or labeling on containers of such preparations shall bear adequate directions to ensure use in compliance with any limitations prescribed in 21 CFR Chapter I, Subchapter A or Subchapter B, or 9 CFR Chapter III, Subchapter A or Subchapter E. (e) Dyes, chemicals, or other substances the use of which is restricted to certain products may be brought into or kept in an official establishment only if such products are prepared thereat. No prohibited dye, chemical, preservative, or other substance shall be brought into or kept in an official establishment. (f) [Reserved] (g) Glands and organs, such as cotyledons, ovaries, prostate glands, tonsils, spinal cords, and detached lymphatic, pineal, pituitary, parathyroid, suprarenal, pancreatic and thyroid glands, used in preparing pharmaceutical, organotherapeutic, or technical products and which are not used as human food (whether or not prepared at official establishments) may be brought into and stored in edible product departments of inspected establishments if packaged in suitable containers so that the presence of such glands and organ will in no way interfere with the maintenance of sanitary conditions or constitute an interference with inspection. Glands or organs which are regarded as human food products, such as livers, testicles, and thymus glands, may be brought into official establishments for pharmaceutical, organotherapeutic or technical purposes, only if U.S. inspected and passed and so identified. Lungs and lung lobes derived from livestock slaughtered in any establishment may not be brought into any official establishment except as provided in § 318.12(a). (h)(1) Carcasses of game animals, and carcasses derived from the slaughter by any person of livestock of his own raising in accordance with the exemption provisions of paragraph 23(a) of the Act, and parts of such carcasses, may be brought into an official establishment for preparation, packaging, and storing in accordance with the provisions of § 303.1(a)(2) of this subchapter. (2) Meat, meat byproducts, and meat food products bearing official marks showing that they were inspected and passed under State inspection in any State not designated under section 301(c) of the Act may be received by official establishments for storage and distribution solely in intrastate commerce. The presence of such State inspected products must not create any unsanitary condition or otherwise result in adulteration of any products at the official establishment or interfere with the conduct of inspection under this subchapter. In addition, such State inspected products must be stored separately and apart from the federally inspected products in the official establishment. (i) The operator of the official establishment shall furnish such information as is necessary to determine the origin of any product or other article entering the official establishment. Such information shall include, but is not limited to, the name and address of the seller or supplier, transportation company, agent, or broker involved in the sale or delivery of the product or article in question. (j) Any product or any poultry or poultry product or other article that is brought into an official establishment contrary to any provision of this section may be required by the Administrator to be removed immediately from such establishment by the operator thereof, and failure to comply with such requirement shall be deemed a violation of this regulation. If any slaughtered poultry or poultry products or other articles are received at an official establishment and are suspected of being adulterated or misbranded under the Poultry Products Inspection Act or the Federal Food, Drug, and Cosmetic Act, or applicable State laws, the appropriate governmental authorities will be notified." 9:9:2.0.2.1.19.1.7.10,9,Animals and Animal Products,III,A,318,PART 318—ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND PREPARATION OF PRODUCTS,A,Subpart A—General,,§ 318.11 [Reserved],FSIS,,,, 9:9:2.0.2.1.19.1.7.11,9,Animals and Animal Products,III,A,318,PART 318—ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND PREPARATION OF PRODUCTS,A,Subpart A—General,,"§ 318.12 Manufacture of uninspected, inedible products at official establishments.",FSIS,,,"[84 FR 40227, Aug. 14, 2019]","(a) Official establishments may manufacture pet food or similar uninspected, inedible products in areas where edible products also are produced, provided that the manufacture of uninspected, inedible products does not: (1) Adulterate edible products; (2) Create insanitary conditions in the official establishment whereby edible products may be adulterated; or (3) Prevent or interfere with inspection or other program tasks performed by FSIS personnel in the official establishment. (b) Pet food and similar uninspected, inedible products must be distinguished from edible products so as to avoid their distribution as human food. Pet food or similar uninspected, inedible products must be labeled or otherwise identified in accordance with § 325.11(d) of this subchapter." 9:9:2.0.2.1.19.1.7.12,9,Animals and Animal Products,III,A,318,PART 318—ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND PREPARATION OF PRODUCTS,A,Subpart A—General,,§ 318.13 Mixtures containing product but not amendable to the Act.,FSIS,,,"[35 FR 15586, Oct. 3, 1970, as amended at 38 FR 29215, Oct. 23, 1973]","Mixtures containing product but not classed as a meat food product under the Act shall not bear the inspection legend or any abbreviation or representation thereof unless manufactured under the food inspection service provided for in part 350 of subchapter B of this chapter. When such mixtures are manufactured in any part of an official establishment, the sanitation of that part of the establishment shall be supervised by Program employees, and the manufacture of such mixtures shall not cause any deviation from the requirement of § 318.1." 9:9:2.0.2.1.19.1.7.13,9,Animals and Animal Products,III,A,318,PART 318—ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND PREPARATION OF PRODUCTS,A,Subpart A—General,,§ 318.14 Adulteration of product by polluted water; procedure for handling.,FSIS,,,"[35 FR 15586, Oct. 3, 1970, as amended at 38 FR 34455, Dec. 14, 1973]","(a) In the event there is polluted water (including but not limited to flood water) in an official establishment, all products and ingredients for use in the preparation of such products that have been rendered adulterated by the water shall be condemned. (b) After the polluted water has receded from an official establishment, all walls, ceilings, posts, and floors of the rooms and compartments involved, including the equipment therein, shall, under the supervision of an inspector, be cleaned thoroughly by the official establishment personnel. An adequate supply of hot water under pressure is essential to make such cleaning effective. After cleaning, a solution of sodium hypochlorite containing approximately one-half of 1 percent available chlorine (5,000 p/m) or other equivalent disinfectant approved by the Administrator 1 shall be applied to the surface of the rooms and equipment and rinsed with potable water before use. (c) Hermetically sealed containers of product which have been contaminated by polluted water shall be examined promptly by the official establishment under supervision of an inspector and rehandled as follows: (1) Separate and condemn all product in damaged or extensively rusted containers. (2) Remove paper labels and wash the remaining containers in warm soapy water, using a brush where necessary to remove rust or other foreign material. Disinfect these containers by either of the following methods: (i) Immerse in a solution of sodium hypochlorite containing not less than 100 p/m of available chlorine or other equivalent disinfectant approved by the Administrator, 1 rinse in potable water, and dry thoroughly; or 1 A list of approved disinfectants is available upon request to Scientific Services, Meat and Poultry Inspection Program, Food Safety and Inspection Service, U.S. Department of Agriculture, Washington, DC 20250. (ii) Immerse in 212 °F. water, bring temperature of the water back to 212 °F. and maintain the temperature at 212 °F. for 5 minutes, then remove containers from water and cool them to 95 °F. and dry thoroughly. (3) After handling as described in paragraph (c)(2) of this section, the containers may be relacquered, if necessary, and then relabeled with approved labels applicable to the product therein. (4) The identity of the canned product shall be maintained throughout all stages of the rehandling operations to insure correct labeling of the containers." 9:9:2.0.2.1.19.1.7.14,9,Animals and Animal Products,III,A,318,PART 318—ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND PREPARATION OF PRODUCTS,A,Subpart A—General,,"§ 318.15 Tagging chemicals, preservatives, cereals, spices, etc., “U.S. retained.”",FSIS,,,,"When any chemical, preservative, cereal, spice, or other substance is intended for use in an official establishment, it shall be examined by a Program employee and if found to be unfit or otherwise unacceptable for the use intended, or if final decision regarding acceptance is deferred pending laboratory or other examination, the employee shall attach a “U.S. retained” tag to the substance or container thereof. The substance so tagged shall be kept separate from other substances as the circuit supervisor may require and shall not be used until the tag is removed, and such removal shall be made only by a Program employee after a finding that the substance can be accepted, or, in the case of an unacceptable substance, when it is removed from the establishment." 9:9:2.0.2.1.19.1.7.15,9,Animals and Animal Products,III,A,318,PART 318—ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND PREPARATION OF PRODUCTS,A,Subpart A—General,,§ 318.16 Pesticide chemicals and other residues in products.,FSIS,,,,"(a) Nonmeat ingredients. Residues of pesticide chemicals, food additives and color additives or other substances in or on ingredients (other than meat, meat byproducts, and meat food products) used in the formulation of products shall not exceed the levels permitted under the Federal Food, Drug, and Cosmetic Act, and such nonmeat ingredients must otherwise be in compliance with the requirements under that Act. (b) Products, and meat, meat byproduct, or other meat food product ingredients. Products, and products used as ingredients of products, shall not bear or contain any pesticide chemical, food additives, or color additive residue in excess of the level permitted under the Federal Food, Drug, and Cosmetic Act and the regulations in this subchapter, or any other substance that is prohibited by such regulations or that otherwise makes the products adulterated. (c) Standards and procedures. Instructions specifying the standards and procedures for determining when ingredients of finished products are in compliance with this section shall be issued to the inspectors by the Administrator. Copies of such instructions will be made available to interested persons upon request made to the Administrator." 9:9:2.0.2.1.19.1.7.16,9,Animals and Animal Products,III,A,318,PART 318—ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND PREPARATION OF PRODUCTS,A,Subpart A—General,,"§ 318.17 Requirements for the production of cooked beef, roast beef, and cooked corned beef products.",FSIS,,,"[64 FR 744, Jan. 6, 1999]","(a) Cooked beef, roast beef, and cooked corned beef products must be produced using processes ensuring that the products meet the following performance standards: (1) Lethality. A 6.5-log 10 reduction of Salmonella or an alternative lethality that achieves an equivalent probability that no viable Salmonella organisms remain in the finished product, as well as the reduction of other pathogens and their toxins or toxic metabolites necessary to prevent adulteration, must be demonstrated to be achieved throughout the product. The lethality process must include a cooking step. Controlled intermediate step(s) applied to raw product may form part of the basis for the equivalency. (2) Stabilization. There can be no multiplication of toxigenic microorganisms such as Clostridium botulinum, and no more than 1-log 10 multiplication of Clostridium perfringens within the product. (b) For each product produced using a process other than one conducted in accordance with the Hazard Analysis and Critical Control Point (HACCP) system requirements in part 417 of this chapter, an establishment must develop and have on file and available to FSIS, a process schedule, as defined in § 301.2 of this chapter. Each process schedule must be approved in writing by a process authority for safety and efficacy in meeting the performance standards established for the product in question. A process authority must have access to the establishment in order to evaluate and approve the safety and efficacy of each process schedule. (c) Under the auspices of a processing authority, an establishment must validate new or altered process schedules by scientifically supportable means, such as information gleaned from the literature or by challenge studies conducted outside the plant." 9:9:2.0.2.1.19.1.7.17,9,Animals and Animal Products,III,A,318,PART 318—ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND PREPARATION OF PRODUCTS,A,Subpart A—General,,§ 318.18 Handling of certain material for mechanical processing.,FSIS,,,"[43 FR 26423, June 20, 1978, as amended at 47 FR 28256, June 29, 1982]","Material to be processed into “Mechanically Separated (Species)” shall be so processed within 1 hour from the time it is cut or separated from carcasses or parts of carcasses, except that such product may be held for no more than 72 hours at 40 °F. (4 °C.) or less, or held indefinitely at 0 °F. (−18 °C.) or less. “Mechanically Separated (Species)” shall, directly after being processed, be used as an ingredient in a meat food product except that it may be held prior to such use for no more than 72 hours at 40 °F. (4 °C.) or less or indefinitely at 0 °F. (−18 °C.) or less." 9:9:2.0.2.1.19.1.7.18,9,Animals and Animal Products,III,A,318,PART 318—ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND PREPARATION OF PRODUCTS,A,Subpart A—General,,§ 318.19 Compliance procedure for cured pork products.,FSIS,,,"[49 FR 14877, Apr. 13, 1984; 49 FR 33434, Aug. 23, 1984, as amended at 59 FR 33642, June 30, 1994; 60 FR 10304, Feb. 24, 1995; 62 FR 45025, Aug. 25, 1997]","(a) Definitions. For the purposes of this section: (1) A product is that cured pork article which is contained within one Group as defined in paragraph (a)(2) of this section and which purports to meet the criteria for a single product designated under the heading “Product Name and Qualifying Statements” in the chart in § 319.104 or the chart in § 319.105. (2) A Product Group or a Group means one of the following: Group I, consisting of cured pork products which have been cooked while imperviously encased. Any product which fits into the Group will be placed in this Group regardless of any other considerations. Group II, consisting of cured pork products which have been water cooked. Any product which does not fit into Group I but does fit into Group II will be placed into Group II regardless of any other considerations. Group III, consisting of boneless smokehouse heated cured pork products. Any boneless product that does not fit into Group I or Group II shall be placed in Group III. Group IV, consisting of bone-in or semi-boneless smokehouse heated cured pork products. Any product that is not completely boneless or still contains all the bone which is traditional for bone-in product, and does not fit into Group I, Group II, or Group III shall be placed in this Group. Group I, consisting of cured pork products which have been cooked while imperviously encased. Any product which fits into the Group will be placed in this Group regardless of any other considerations. Group II, consisting of cured pork products which have been water cooked. Any product which does not fit into Group I but does fit into Group II will be placed into Group II regardless of any other considerations. Group III, consisting of boneless smokehouse heated cured pork products. Any boneless product that does not fit into Group I or Group II shall be placed in Group III. Group IV, consisting of bone-in or semi-boneless smokehouse heated cured pork products. Any product that is not completely boneless or still contains all the bone which is traditional for bone-in product, and does not fit into Group I, Group II, or Group III shall be placed in this Group. (3) A lot is that product from one production shift. (4) A production rate is frequency of production, expressed in days per week. (5) Protein fat free percentage, protein fat free content, PFF percentage, PFF content or PFF of a product means the meat protein (indigenous to the raw, unprocessed pork cut) content expressed as a percent of the non-fat portion of the finished product. (b) Normal Compliance Procedures. The Department shall collect samples of cured pork products and analyze them for their PFF content. Analyses shall be conducted in accordance with the “Official Methods of Analysis of the Association of Official Analytical Chemists §§ 950.46, and 928.08 (Chapter 39). 1 The “Official Methods of Analysis of the Association of Official Analytical Chemists,” 15th edition, 1990, is incorporated by reference with the approval of the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Each analytical result shall be recorded and evaluated to determine whether future sampling of product Groups within an official establishment shall be periodic or daily under the provisions of paragraph (b)(1) of this section, and if the affected lot and subsequent production of like product shall be U.S. retained, or administratively detained, as appropriate, as provided in paragraph (b)(2) of this section. 2 1 A copy of the “Official Methods of Analysis of the Association of Official Analytical Chemists,” 15th edition, 1990, is on file with the Director, Office of the Federal Register, and may be purchased from the Association of Official Analytical Chemists, Inc., 2200 Wilson Boulevard, Suite 400, Arlington, Virginia 22201. 2 Rules for Rounding: 1. Laboratory results for percent meat protein and fat will be reported to the second decimal place (hundredths). 2. PFF and Sample Values for charting purposes will be calculated from the reported laboratory results to the second decimal place. Rounding of calculations to reach two decimal places will be done by the following rule: All values of five-thousandths (0.005) or more will be rounded up to the next highest hundredth. All values of less than five-thousandths (0.005) will be dropped. 3. For compliance with the Absolute Minimum PFF requirements, the PFF will be rounded to the first decimal place (tenths). Rounding of calculations to reach one decimal place will be done by the following rule: All PFF values of five-hundredths (0.05) or more will be rounded up to the next highest tenth. All PFF values of less than five-hundredths (0.05) will be dropped. 4. For product disposition (pass-fail of a minimum PFF standard for retained product) the average PFF calculation will be rounded to the first decimal place. Individual PFF Values will be calculated to the nearest hundredth as in (2) above. The average, however, will be rounded to the nearest tenth as in (3) above. (1) Criteria to determine sampling frequency of Product Groups. For each official plant preparing cured pork products, Product Groups shall be sampled periodically or daily. Analytical results shall be evaluated and the sampling frequency determined as follows: (i) Determine the difference between the individual PFF analysis and the applicable minimum PFF percentage requirement of § 319.104 or § 319.105. The resulting figure shall be negative when the individual sample result is less than the applicable minimum PFF percentage requirement and shall be positive when the individual sample result is greater than the applicable minimum PFF percentage requirement. (ii) Divide the resulting number by the standard deviation assigned to the Product Group represented by the sample to find the Standardized Difference. The standard deviation assigned to Groups I and II is 0.75 and to Groups III and IV is 0.91. (iii) Add 0.25 to the Standardized Difference to find the Adjusted Standardized Difference. (iv) Use the lesser of 1.90 and the Adjusted Standardized Difference as the Sample Value. (v) Cumulatively total Sample Values to determine the Group Value. The first Sample Value in a Group shall be the Group Value, and each succeeding Group Value shall be determined by adding the most recent Sample Value to the existing Group Value; provided, however, that in no event shall the Group Value exceed 1.00. When calculation of a Group Value results in a figure greater than 1.00, the Group Value shall be 1.00 and all previous Sample Values shall be ignored in determining future Group Values. (vi) The frequency of sampling of a Group shall be periodic when the Group Value is greater than −1.40 (e.g., −1.39, −1.14, 0, 0.50, etc.) and shall be daily when the Group Value is −1.40 or less (e.g., −1.40, −1.45, −1.50, etc.); provided, however, that once daily sampling has been initiated, it shall continue until the Group Value is 0.00 or greater, and each of the last seven Sample Values is −1.65 or greater (e.g., −1.63, −1.50, etc.), and there is no other product within the affected Group being U.S. retained as produced, under provisions of paragraph (b)(2) or (c). (2) Criteria for U.S. retention or administrative detention of cured pork products for further analysis. Cured prok products shall be U.S. retained, or administratively detained, as appropriate, when prescribed by paragraphs (b)(2) (i) or (ii) of this section as follows: (i) Absolute Minimum PFF Requirement. In the event that an analysis of an individual sample indicates a PFF content below the applicable minimum requirement of § 319.104 or § 319.105 by 2.3 or more percentage points for a Group I or II product, or 2.7 or more percentage points for a Group III or IV product, the lot from which the sample was collected shall be U.S. retained if in an official establishment and shall be subject to administrative detention if not in an official establishment unless returned to an official establishment and there U.S. retained. Any subsequently produced lots of like product and any lots of like product for which production dates cannot be established shall be U.S. retained or subject to administrative detention. Such administratively detained product shall be handled in accordance with part 329 of this subchapter, or shall be returned to an official establishment and subjected to the provisions of paragraph (c)(1) (i) or (ii) of this section, or shall be relabeled in compliance with the applicable standard, under the supervision of a program employee, at the expense of the product owner. Disposition of such U.S. retained product shall be in accordance with paragraph (c) of this section. (ii) Product Value requirement. The Department shall maintain, for each product prepared in an official establishment, a Product Value. Except as provided in paragraph (c)(2) of this section, calculation of the Product Value and its use to determine if a product shall be U.S. retained shall be as follows: (A) Determine the difference between the individual PFF analysis and applicable minimum PFF percentage requirement of § 319.104 and § 319.105. The resulting figure shall be negative when the individual sample result is less than the applicable minimum PFF percentage requirement and shall be positive when the individual sample result is greater than the applicable minimum PFF percentage requirement. (B) Divide the difference determined in paragraph (b)(2)(ii)(A) of this section by the standard deviation assigned to the product's Group in paragraph (b)(1)(ii) of this section to find the standardized difference. (C) Use the lesser of 1.65 and the standardized difference as the Sample Value. (D) Cumulatively total Sample Values to determine the Product Value. The first Sample Value of a product shall be the Product Value, and each succeeding Product Value shall be determined by adding the most recent Sample Value to the existing Product Value; provided, however, that in no event shall the Product Value exceed 1.15. When calculation of a Product Value results in a figure greater than 1.15, the Product Value shall be 1.15, and all previous Sample Values shall be ignored in determining future Product Values. (E) Provided daily group sampling is in effect pursuant to the provisions of paragraph (b)(1) of this section, and provided further the Product Value is −1.65 or less (e.g., −1.66), the affected lot (if within the official establishment) and all subsequent lots of like product prepared by and still within the official establishment shall be U.S. retained and further evaluated under paragraph (c) of this section. Except for release of individual lot pursuant to paragraph (c)(1), subsequently produced lots of like product shall continue to be U.S. retained until discontinued pursuant to paragraph (c)(2) of this section. (c) Compliance procedure during product retention. When a product lot is U.S. retained under the provisions of paragraph (b)(2) of this section, the Department shall collect three randomly selected samples from each such lot and analyze them individually for PFF content. The PFF content of the three samples shall be evaluated to determine disposition of the lot as provided in paragraph (c)(1) of this section and the action to be taken on subsequently produced lots of like product as provided in paragraph (c)(2) of this section. 3 3 If the processor does not wish to have the product evaluated in this manner, alternate sampling plans may be used provided such plans have been formulated by the processor and approved by the Administrator prior to evaluation by the three-sample criteria, and provided the analyses specified in such plans are performed at the expense of the processor. (1) A product lot which is U.S. retained under the provisions of paragraph (b)(2) of this section may be released for entry into commerce provided one of the following conditions is met: (i) The average PFF content of the three samples randomly selected from the lot is equal to or greater than the applicable minimum PFF percentage required by § 319.104 or § 319.105. Further processing to remove moisture for the purpose of meeting this provision is permissible. In lieu of further analysis to determine the effects of such processing, each 0.37 percent weight reduction due to moisture loss resulting from the processing may be considered the equivalent of a 0.1 percent PFF gain. (ii) The lot of the product is relabeled to conform to the provisions of § 319.104 or § 319.105, under the supervision of a program employee. (iii) The lot is one that has been prepared subsequent to preparation of the lot which, under the provisions of paragraph (c)(2) of this section, resulted in discontinuance of U.S. retention of new lots of like product. Such lot may be released for entry into commerce prior to receipt of analytical results for which sampling has been conducted. Upon receipt of such results, they shall be subjected to the provisions of paragraphs (b)(2)(i) and (c)(2) of this section. (2) The PFF content of three randomly selected samples from each U.S. retained lot shall be used to maintain the Product Value described in paragraph (c)(2)(ii). The manner and effect of such maintenance shall be as follows: (i) Find the average PFF content of the three samples. (ii) Determine the difference between that average and the applicable minimum PFF percentage requirement of § 319.104 or § 319.105. The resulting figure shall be negative when the average of the sample results is less than the applicable minimum PFF percentage requirement and shall be positive when the average of the sample results is greater than the applicable minimum PFF requirements. (iii) Divide the resulting figure by the standard deviation assigned to the product's Group in paragraph (b)(1)(ii) of this section, to find the standardized difference. (iv) Use the lesser of 1.30 and the standardized difference as the Sample Value. (v) Add the first Sample Value thus calculated to the latest Product Value calculated under the provisions of paragraph (c)(2)(ii) of this section to find the new Product Value. To find each succeeding Product Value, add the most recent Sample Value to the existing Product Value; provided, however, that in no event shall the Product Value exceed 1.15. When the addition of a Sample Value to an existing Product Value results in a figure greater than 1.15, the Product Value shall be 1.15 and all previous Sample Values shall be ignored in determining future Product Values. (vi) New lots of like product shall continue to be retained pending disposition in accordance with paragraph (c)(1) of this section until, after 5 days of production, the Product Value is 0.00 or greater, and the PFF content of no individual sample from a U.S. retained lot is less than the Absolute Minimum PFF requirement specified in paragraph (b)(2)(i) of this section. Should an individual sample fail to meet its Absolute Minimum PFF requirement, the 5-day count shall begin anew. (vii) When U.S. retention of new lots is discontinued under the above provisions, maintenance of the Product Value shall revert to the provisions of paragraph (b)(2)(ii) of this section. (3) For purposes of this section, the plant owner or operator shall have the option of temporarily removing a product from its Product Group, provided product lots are being U.S. retained, as produced, and provided further that the average production rate of the product, over the 8-week period preceding the week in which the first U.S. retained lot was prepared, is not greater than 20 percent of the production rate of its Group. When a product is thus removed from its Group, analytical results of product samples shall not cause daily sampling of the Group. When pursuant to paragraph (c)(2)(vi) of this section, new lots of the product are no longer being U.S. retained, the product shall again be considered with its Group. (d) Adulterated and misbranded products. Products not meeting specified PFF requirements, determined according to procedures set forth in this section, may be deemed adulterated under section 1(m)(8) of the Act (21 U.S.C. 601(m)(8)) and misbranded under section 1(n) of the Act (21 U.S.C. 601(n)). (e) Quality control. Cured pork products bearing on their labeling the statement “X% of Weight is Added Ingredients” shall be prepared only under a quality control system or program in accordance with § 318.4 of this subchapter. With respect to any other cured pork product, official establishments may institute quality control procedures under § 318.4 of this subchapter. Cured pork products produced in such establishments may be exempt from the requirements of this section, provided in plant quality control procedures are shown to attain the same or higher degree of compliance as the procedures set forth in this section; provided, however, that all cured pork products produced shall be subject to the applicable Absolute Minimum PFF content requirement, regardless of any quality control procedures in effect." 9:9:2.0.2.1.19.1.7.19,9,Animals and Animal Products,III,A,318,PART 318—ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND PREPARATION OF PRODUCTS,A,Subpart A—General,,§ 318.20 Use of animal drugs.,FSIS,,,"[50 FR 32165, Aug. 9, 1985]","Animal drug residues are permitted in meat and meat food products if such residues are from drugs which have been approved by the Food and Drug Administration and any such drug residues are within tolerance levels approved by the Food and Drug Administration, unless otherwise determined by the Administrator and listed herein." 9:9:2.0.2.1.19.1.7.2,9,Animals and Animal Products,III,A,318,PART 318—ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND PREPARATION OF PRODUCTS,A,Subpart A—General,,"§ 318.2 Reinspection, retention, and disposal of meat and poultry products at official establishments.",FSIS,,,"[35 FR 15586, Oct. 3, 1970; 36 FR 11903, June 23, 1971]","(a) All products and all slaughtered poultry and poultry products brought into any official establishment shall be identified by the operator of the official establishment at the time of receipt at the official establishment and shall be subject to reinspection by a Program employee at the official establishment in such manner and at such times as may be deemed necessary to assure compliance with the regulations in this subchapter. (b) All products, whether fresh, cured, or otherwise prepared, even though previously inspected and passed, shall be reinspected by Program employees as often as they may deem necessary in order to ascertain that they are not adulterated or misbranded at the time they enter or leave official establishments and that the requirements of the regulations in this subchapter are complied with. (c) Reinspection may be accomplished through use of statistically sound sampling plans that assure a high level of confidence. The circuit supervisor shall designate the type of plan and the program employee shall select the specific plan to be used in accordance with instructions issued by the Administrator. 1 1 Further information concerning sampling plans which have been adopted for specific products may be obtained from the Circuit Supervisors of Program circuits. These sampling plans are developed for individual products by the Washington staff and will be distributed for field use as they are developed. The type of plan applicable depends on factors such as whether the product is in containers, stage of preparation, and procedures followed by the establishment operator. The specific plan applicable depends on the kind of product involved, such as liver, oxtails, etc. (d) A U.S. retained tag shall be placed by a Program employee at the time of reinspection at any official establishment on all products which are suspected on such reinspection of being adulterated or misbranded, and such products shall be held for further inspection. Such tags shall be removed only by authorized Program employees. When further inspection is made, if the product is found to be adulterated, all official inspection legends or other official marks for which the product is found to be ineligible under the regulations in this subchapter, shall be removed or defaced and the product will be subject to condemnation and disposal in accordance with part 314 of this subchapter, except that a determination regarding adulteration may be deferred if a product has become soiled or unclean by falling on the floor or in any other accidental way or if the product is affected with any other condition which the inspector deems capable of correction, in which case the product shall be cleaned (including trimming if necessary) or otherwise handled in a manner approved by the inspector to assure that it will not be adulterated or misbranded and shall then be presented for reinspection and disposal in accordance with this section. If upon final inspection, the product is found to be neither adulterated nor misbranded, the inspector shall remove the U.S. retained tag. If a product is found upon reinspection to be misbranded, it shall be held under a U.S. retained tag, or a U.S. detention tag as provided in part 329 of this subchapter, pending correction of the misbranding or issuance of an order under section 7 of the Act to withhold from use the labeling or container of the product, or the institution of a judicial seizure action under section 403 of Act or other appropriate action. The inspector shall make a complete record of each transaction under this paragraph and shall report his action to the area supervisor." 9:9:2.0.2.1.19.1.7.20,9,Animals and Animal Products,III,A,318,PART 318—ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND PREPARATION OF PRODUCTS,A,Subpart A—General,,§ 318.21 [Reserved],FSIS,,,, 9:9:2.0.2.1.19.1.7.21,9,Animals and Animal Products,III,A,318,PART 318—ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND PREPARATION OF PRODUCTS,A,Subpart A—General,,§ 318.22 Determination of added water in cooked sausages.,FSIS,,,"[55 FR 7299, Mar. 1, 1990]","(a) For purposes of this section, the following definitions apply. (1) Cooked sausage. Cooked sausage is any product described in § 319.140 and §§ 319.180-319.182 of this chapter. (2) Group 1 Protein-Contributing Ingredients. Ingredients of livestock or poultry origin from muscle tissue which is skeletal or which is found in the edible organs, with or without the accompanying and overlying fat, and the portions of bone, skin, sinew, nerve, and blood vessels which normally accompany the muscle tissue and which are not separated from it in the process of dressing; meat byproducts; mechanically separated (species); and poultry products; except those ingredients processed by hydrolysis, extraction, concentrating or drying. (3) Group 2 Protein-Contributing Ingredients. Ingredients from Gorup 1 protein-contributing ingredients processed by hydrolysis, extraction, concentrating, or drying, or any other ingredient which contributes protein. (b) The amount of added water in cooked sausage is calculated by: (1) Determining by laboratory analysis the total percentage of water contained in the cooked sausage; and (2) Determining by laboratory analysis the total percentage of protein contained in the cooked sausage; and (3) Calculating the percentage of protein in the cooked sausage contributed by the Group 2 protein-contributing ingredients; and (4) Subtracting one pecent from the total percentage of protein calculated in (b)(3)); and (5) Subtracting the remaining percentage of protein calculated in (b)(3) from the total protein content determined in (b)(2); and (6) Calculating the percentage of indigenous water in the cooked sausage by multiplying the percentage of protein determined in (b)(5) by 4, (This amount is the percentage of water attributable to Group 1 protein-contributing ingredients and one percent of Group 2 protein-contributing ingredients in a cooked sausage.); and (7) Subtracting the percentage of water calculated in (b)(6) from the total percentage of water determined in (b)(1). (This amount is the percentage of added water in a cooked sausage.) 1 1 The equation for the narrative description of the calculation for added water is as follows: AW = TW-(TP-(P-1.0))4, Where AW = Added Water, TW-Total Water Determined by Laboratory Analysis, TP = Total Protein Determined by Laboratory Analysis, P = Protein Contributed by Group 2 Protein-Contributing Ingredients, 1.0 = Percent Allowance for Group 2 Protein-Contributing Ingredients, 4 = Moisture-Protein Ratio for Cooked Sausage." 9:9:2.0.2.1.19.1.7.22,9,Animals and Animal Products,III,A,318,PART 318—ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND PREPARATION OF PRODUCTS,A,Subpart A—General,,§ 318.23 Heat-processing and stabilization requirements for uncured meat patties.,FSIS,,,"[64 FR 744, Jan. 6, 1999]","(a) Definitions. For purposes of this section, the following definitions shall apply: (1) Patty. A shaped and formed, comminuted, flattened cake of meat food product. (2) Comminuted. A processing term describing the reduction in size of pieces of meat, including chopping, flaking, grinding, or mincing, but not including chunking or sectioning. (3) Partially-cooked patties. Meat patties that have been heat processed for less time or using lower internal temperatures than are prescribed by paragraph (b)(1) of this section. (4) Char-marked patties. Meat patties that have been marked by a heat source and that have been heat processed for less time or using lower internal temperatures than are prescribed by paragraph (b)(1) of this section. (b) Heat-processing procedures for fully-cooked patties. (1) Official establishments which manufacture fully-cooked patties shall use one of the following heat-processing procedures: Permitted Heat-Processing Temperature/Time Combinations for Fully-Cooked Patties (2) The official establishment shall measure the holding time and temperature of at least one fully-cooked patty from each production line each hour of production to assure control of the heat process. The temperature measuring device shall be accurate within 1 degree F. (3) Requirements for handling heating deviations. (i) If for any reason a heating deviation has occurred, the official establishment shall investigate and identify the cause; take steps to assure that the deviation will not recur; and place on file in the official establishment, available to any duly authorized FSIS program employee, a report of the investigation, the cause of the deviation, and the steps taken to prevent recurrence. (ii) In addition, in the case of a heating deviation, the official establishment may reprocess the affected product, using one of the methods in paragraph (b)(1) in this section; use the affected product as an ingredient in another product processed to one of the temperature and time combinations in paragraph (b)(1) in this section, provided this does not violate the final product's standard of composition, upset the order of predominance of ingredients, or perceptibly affect the normal product characteristics; or relabel the affected product as a partially-cooked patty product, if it meets the stabilization requirements in paragraph (c) of this section. (c) Stabilization. (1) Fully cooked, partially cooked, and char-marked meat patties must be produced using processes ensuring no multiplication of toxigenic microorganisms such as Clostridium botulinum, and no more than a 1 log 10 multiplication of Clostridium perfringens, within the product. (2) For each meat patty product produced using a stabilization process other than one conducted in accordance with the Hazard Analysis and Critical Control Point (HACCP) system requirements in part 417 of this chapter, an establishment must develop and have on file, available to FSIS, a process schedule, as defined in § 301.2 of this chapter. Each process schedule must be approved in writing by a process authority for safety and efficacy in meeting the performance standards established for the product in question. A process authority must have access to an establishment in order to evaluate and approve the safety and efficacy of each process schedule. (3) Under the auspices of a processing authority, an establishment must validate new or altered process schedules by scientifically supportable means, such as information gleaned from the literature or by challenge studies conducted outside the plant. (4) Partially cooked patties must bear the labeling statement “Partially cooked: For Safety Cook Until Well Done (Internal Meat Temperature 160 degrees F.).” The labeling statement must be adjacent to the product name, and prominently placed with such conspicuousness (as compared with other words, statements, designs or devices in the labeling) as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use. (5) Char-marked patties must bear the labeling statement “Uncooked, Char-marked: For Safety, Cook Until Well Done (Internal Meat Temperature 160 degrees F.).” The labeling statement shall be adjacent to the product name, at least one-half the size of the largest letter in the product name, and prominently placed with such conspicuousness (as compared with other words, statements, designs or devices in the labeling) as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use." 9:9:2.0.2.1.19.1.7.23,9,Animals and Animal Products,III,A,318,PART 318—ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND PREPARATION OF PRODUCTS,A,Subpart A—General,,§ 318.24 Product prepared using advanced meat/bone separation machinery; process control.,FSIS,,,"[69 FR 1884, Jan. 12, 2004]","(a) General. Meat, as defined in § 301.2 of this subchapter, may be derived by mechanically separating skeletal muscle tissue from the bones of livestock, other than skulls or vertebral column bones of cattle 30 months of age and older as provided in § 310.22 of this subchapter, using advances in mechanical meat/bone separation machinery ( i.e., AMR systems) that, in accordance with this section, recover meat— (1) Without significant incorporation of bone solids or bone marrow as measured by the presence of calcium and iron in excess of the requirements in this section, and (2) Without the presence of any brain, trigeminal ganglia, spinal cord, or dorsal root ganglia (DRG). (b) Process control. As a prerequisite to labeling or using product as meat derived by the mechanical separation of skeletal muscle tissue from livestock bones, the operator of an establishment must develop, implement, and maintain procedures that ensure that the establishment's production process is in control. (1) The production process is not in control if the skulls entering the AMR system contain any brain or trigeminal ganglia tissue, if the vertebral column bones entering the AMR system contain any spinal cord, if the recovered product fails otherwise under any provision of paragraph (c)(1), if the product is not properly labeled under the provisions of paragraph (c)(2), or if the spent bone materials are not properly handled under the provisions of paragraph (c)(3) of this section. (2) The establishment must document its production process controls in writing. The program must be designed to ensure the on-going effectiveness of the process controls. If the establishment processes cattle, the program must be in its HACCP plan, its Sanitation SOP, or other prerequisite program. The program shall describe the on-going verification activities that will be performed, including the observation of the bones entering the AMR system for brain, trigeminal ganglia, and spinal cord; the testing of the product exiting the AMR system for bone solids, bone marrow, spinal cord, and DRG as prescribed in paragraph (c)(1) of this section; the use of the product and spent bone materials exiting the AMR system; and the frequency with which these activities will be performed. (3) The establishment shall maintain records on a daily basis sufficient to document the implementation and verification of its production process. (4) The establishment shall make available to inspection program personnel the documentation described in paragraphs (b)(2) and (b)(3) of this section and any other data generated using these procedures. (c) Noncomplying product. (1) Notwithstanding any other provision of this section, product that is recovered using advanced meat/bone separation machinery is not meat under any one or more of the following circumstances: (i) Bone solids. The product's calcium content, measured by individual samples and rounded to the nearest 10th, is more than 130.0 mg per 100 g. (ii) Bone marrow. The product's added iron content, measured by duplicate analyses on individual samples and rounded to the nearest 10th, is more than 3.5 mg per 100 g. 1 1 The excessive iron (ExcFe) measurement for an analyzed sample is equal to the obtained iron (Fe) result expressed in mg/100 g measured and rounded to the nearest 100th or more for that sample, minus the product of three factors: (1) The iron to protein ratio (IPR) factor associated with corresponding hand-deboned product; (2) the obtained protein (P) result (%) for that sample; and (3) a constant factor of 1.10. In formula, this can be written as: ExcFe = mFe − IPR × Protein × 1.10, where ExcFe represents the excess iron, expressed in units of mg/100 g; mFe represents the measured level of iron (Fe, mg/100 g), IPR is the iron to protein ratio for the appropriate hand-deboned product, and “Protein” is the measured level of protein rounded to the nearest 100th and expressed as a percentage of the total weight of the sample. In lieu of data demonstrating otherwise, the values of IPR to be used in the above formula are as follows: For beef products the value of IPR is equal to 0.104, except for any combination of bones that include any beef neckbone product, for which the value of 0.138 is to be used; for pork product, the IPR value is 0.052. Other IPR values can be used provided that the operator of an establishment has verified and documented the ratio of iron content to protein content in the skeletal muscle tissue attached to bones prior to their entering the AMR system, based on analyses of hand-deboned samples, and the documented value is to be substituted for the IPR value (as applicable) in the above formula with respect to product that the establishment mechanically separates from those bones. (iii) Brain or trigeminal ganglia. Skulls that enter the AMR system have tissues of brain or trigeminal ganglia. (iv) Spinal cord. Vertebral column bones that enter the AMR system have tissues of spinal cord, or the product that exits the AMR system contains spinal cord. (v) DRG. The product that exits the AMR system contains DRG. (2) If product that may not be labeled or used as “meat” under this section meets the requirements of § 319.5 of this subchapter, it may bear the name “Mechanically Separated (Species)” except as follows: (i) If skulls or vertebral column bones of cattle younger than 30 months of age that enter the AMR system have tissues of brain, trigeminal ganglia, or spinal cord, the product that exits the AMR system shall not be used as an ingredient of a meat food product. (ii) If product that exits the AMR system contains spinal cord or DRG from bones of cattle younger than 30 months of age, it shall not be used as an ingredient of a meat food product. (iii) If product derived from any bones of cattle of any age does not comply with (c)(1)(i) or (ii), it may bear a common or usual name that is not false or misleading, except that the product may not bear the name “Mechanically Separated (Beef).” (3) Spent skulls or vertebral column bone materials from cattle younger than 30 months of age that exit the AMR system shall not be used as an ingredient of a meat food product." 9:9:2.0.2.1.19.1.7.3,9,Animals and Animal Products,III,A,318,PART 318—ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND PREPARATION OF PRODUCTS,A,Subpart A—General,,§ 318.3 Designation of places of receipt of products and other articles for reinspection.,FSIS,,,,"Every official establishment shall designate, with the approval of the circuit supervisor, a dock or place at which products and other articles subject to reinspection under § 318.2 shall be received, and such products and articles shall be received only at such dock or place." 9:9:2.0.2.1.19.1.7.4,9,Animals and Animal Products,III,A,318,PART 318—ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND PREPARATION OF PRODUCTS,A,Subpart A—General,,§ 318.4 Preparation of products to be officially supervised; responsibilities of official establishments; plant operated quality control.,FSIS,,,"[35 FR 15586, Oct. 3, 1970, as amended at 36 FR 12003, June 24, 1971; 45 FR 54322, Aug. 15, 1980; 51 FR 32304, Sept. 11, 1986; 62 FR 45024, Aug. 25, 1997; 62 FR 54759, Oct. 22, 1997; 65 FR 34389, May 30, 2000; 78 FR 66837, Nov. 7, 2013]","(a) All processes used in curing, pickling, rendering, canning, or otherwise preparing any product in official establishments shall be supervised by Program employees unless such preparation is conducted as a custom operation exempted from inspection under § 303.1(a)(2) of this subchapter in any official establishment or consists of operations that are exempted from inspection under § 303.1(d) of this subchapter and are conducted in a retail store in an establishment subject to inspection only because the State or Territory in which the establishment is located is designated under paragraph 301(c) of the Act. No fixtures or appliances, such as tables, trucks, trays, tanks, vats, machines, implements, cans, or containers of any kind, shall be used unless they are of such materials and construction as will not contaminate or otherwise adulterate the product and are clean and sanitary. All steps in the preparation of edible products shall be conducted carefully and with strict cleanliness in rooms or compartments separate from those used for inedible products. (b) It shall be the responsibility of the operator of every official establishment to comply with the Act and the regulations in this subchapter. In order to carry out this responsibility effectively, the operator of the establishment shall institute appropriate measures to assure the maintenance of the establishment and the preparation, marking, labeling, packaging and other handling of its products strictly in accordance with the sanitary and other requirements of this subchapter. The effectiveness of such measures will be subject to review by the Department. (c) Applying for Total Plant Quality Control. Any owner or operator of an official establishment preparing meat food product who has a total plant quality control system or plan for controlling such product, after ante-mortem and post-mortem inspection, through all stages of preparation, may request the Administrator to evaluate it to determine whether or not that system is adequate to result in product being in compliance with the requirements of the Act and therefore qualify as a U.S. Department of Agriculture (USDA) Total Plant Quality Control Establishment. Such a request shall, as a minimum, include: (1) A letter to the Administrator from the establishment owner of operator stating the company's basis and purpose for seeking an approved quality control system and willingness to adhere to the requirements of the system as approved by the Department; that all the establishment's data, analyses, and information generated by its quality control system will be maintained to enable the Department to monitor compliance and available to Department personnel; that plant quality control personnel will have authority to halt production or shipping of product in cases where the submitted quality control system requires it; and that the owner or operator (or his/her designee) will be available for consultation at any time Department personnel consider it necessary. (2) In the case of an establishment having one or more full-time persons whose primary duties are related to the quality control system, an organizational chart showing that such people ultimately report to an establishment official whose quality control responsibilities are independent of or not predominantly production responsibilities. In the case of an establishment which does not have full-time quality control personnel, information indicating the nature of the duties and responsibilities of the person who will be responsible for the quality control system. (3) A list identifying those parts and sections of the Federal meat inspection regulations which are applicable to the operations of the establishment applying for approval of a quality control system. This list shall also identify which part of the quality control system will serve to maintain compliance with the applicable regulations. (4) Detailed information concerning the manner in which the system will function. Such information should include, but not necessarily be limited to, questions of raw material control, the critical check or control points, the nature and frequency of tests to be made, the nature of charts and other records that will be used, the length of time such charts and records will be maintained in the custody of the official establishment, the nature of deficiencies the quality control system is designed to identify and control, the parameters or limits which will be used, and the points at which corrective action will occur and the nature of such corrective action—ranging from least to most severe: Provided, That, subsequent to approval of the total plant quality control system by the Administrator, the official establishment may produce a new product for test marketing provided labeling for the product has been approved by the Administrator, the inspector in charge has determined that the procedures for preparing the product will assure that all Federal requirements are met, and the production for test marketing does not exceed 6 months. Such new product shall not be produced at that establishment after the 6-month period unless approval of the quality control system for that product has been received from the Administrator. (d) [Reserved] (e) Evaluation and Approval of Total Plant Quality Control. (1) The Administrator shall evaluate the material presented in accordance with the provisions of paragraph (c) of this section. If it is determined by the Administrator, on the basis of the evaluation, that the total quality control system will result in finished products controlled in this manner being in full compliance with the requirements of the Act and regulations thereunder, the total quality control system will be approved and plans will be made for implementation under departmental supervision. (2) In any situation where the system is found by the Administrator to be unacceptable, formal notification shall be given to the applicant of the basis for the denial. The applicant will be afforded an opportunity to modify the system in accordance with the notification. The applicant shall also be afforded an opportunity to submit a written statement in response to this notification of denial and a right to request a hearing with respect to the merits or validity of the denial. If the applicant requests a hearing and the Administrator, after review of the answer, determines the initial determination to be correct, he shall file with the Hearing Clerk of the Department the notification, answer and the request for hearing, which shall constitute the complaint and answer in the proceeding, which shall thereafter be conducted in accordance with Rules of Practice which shall be adopted for this proceeding. (3) The establishment owner or operator shall be responsible for the effective operation of the approved total plant quality control system to assure compliance with the requirements of the Act and regulations thereunder. The Secretary shall continue to provide the Federal inspection necessary to carry out his responsibilities under the Act. (f) Labeling Logo. Owners and operators of official establishments having a total plant quality control system approved under the provisions of paragraph (c) of this section may only use, as a part of any label, the following logo. (g) Termination of Total Plant Quality Control. (1) The approval of a total plant quality control system may be terminated at any time by the owner or operator of the official establishment upon written notice to the Administrator. (2) The approval of a total plant quality control system may be terminated upon the establishment's receipt of a written notice from the Administrator under the following conditions: (i) If adulterated or misbranded meat food product is found by the Administrator to have been prepared for or distributed in commerce by the subject establishment. In such case, opportunity will be provided to the establishment owner or operator to present views to the Administrator within 30 days of the date of terminating the approval. In those instances where there is conflict of facts, a hearing, under applicable Rules of Practice, will be provided to the establishment owner or operator to resolve the conflict. The Administrator's termination of approval shall remain in effect pending the final determination of the proceeding. (ii) If the establishment fails to comply with the quality control system or program to which it has agreed after being notified by letter from the Administrator or his designee. Prior to such termination, opportunity will be provided to the establishment owner or operator to present views to the Administrator within 30 days of the date of the letter. In those instances where there is a conflict of facts, a hearing, under applicable Rules of Practice, will be provided to the establishment owner or operator to resolve the conflict. The Administrator's termination of quality control approval shall remain in effect pending the final determination of the proceeding. (3) If approval of the total establishment quality control system has been terminated in accordance with the provisions of this section, an application and request for approval of the same or a modified total establishment quality control system will not be evaluated by the Administrator for at least 6 months from the termination date. (h)(1) Operating Schedule Under Total Plant Quality Control. An official establishment with an approved total plant quality control system may request approval for an operating schedule of up to 12 consecutive hours per shift. Permission will be granted provided that: (i) The official establishment has satisfactorily operated under a total plant quality control system for at least 1 year. (ii) All products prepared and packaged, or processed after the end of 8 hours of inspection shall only be a continuation of the processing monitored by the inspector and being conducted during the last hour of inspection. (iii) All immediate containers of products prepared and packaged shall bear code marks that are unique to any period of production beyond the 8 hours of inspection. The form of such code marks will remain constant from day to day, and a facsimile of the code marks and their meaning shall be provided to the inspector. (2) Application. Applications shall be submitted to the Regional Director and shall specify how the conditions in § 318.4(h)(1) have been or will be met. (3) Monitoring by Inspectors. In order to verify that an establishment is preparing and shipping product in accordance with the approved total plant quality control system and the Act and regulations after the 8 hours of inspection, the official establishment may be provided overtime inspection services at the discretion of the circuit supervisor and charged for such services." 9:9:2.0.2.1.19.1.7.5,9,Animals and Animal Products,III,A,318,PART 318—ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND PREPARATION OF PRODUCTS,A,Subpart A—General,,§ 318.5 Requirements concerning procedures.,FSIS,,,"[35 FR 15586, Oct. 3, 1970; 36 FR 11903, June 23, 1971]","(a)(1) Care shall be taken to assure that product is not adulterated when placed in freezers. If there is doubt as to the soundness of any frozen product, the inspector will require the defrosting and reinspection of a sufficient quantity thereof to determine its actual condition. (2) Frozen product may be defrosted in water or pickle in a manner and with the use of facilities which are acceptable to the inspector. Before such product is defrosted, a careful examination shall be made to determine its condition. If necessary, this examination shall include defrosting of representative samples by means other than in water or pickle. (b) Product, such as pork tenderloins, brains, sweetbreads, stew, or chop suey, shall not be packed in hermetically sealed metal or glass containers, unless subsequently heat processed or otherwise treated to preserve the product in a manner approved by the Administrator in specific cases. (c) Care shall be taken to remove bones and parts of bones from product which is intended for chopping. (d) Heads for use in the preparation of meat food products shall be split and the bodies of the teeth, the turbinated and ethmoid bones, ear tubes, and horn butts removed, and the heads then thoroughly cleaned. (e) Kidneys for use in the preparation of meat food products shall first be freely sectioned and then thoroughly soaked and washed. All detached kidneys, including beef kidneys with detached kidney fat, shall be inspected before being used in or shipped from the official establishment. (f) Cattle paunches and hog stomachs for use in the preparation of meat food products shall be thoroughly cleaned on all surfaces and parts immediately after being emptied of their contents, which shall follow promptly their removal from the carcasses. (g) Clotted blood shall be removed from hog hearts before they are shipped from the official establishment or used in the preparation of meat food products. (h) Beef rounds, beef bungs, beef middles, beef bladders, calf rounds, hog bungs, hog middles, and hog stomachs which are to be used as containers of any meat food product shall be presented for inspection, turned with the fat surface exposed. (i) Portions of casings which show infection with Oesophagostomum or other nodule-producing parasite, and weasands infected with the larvae of Hypoderma lineatum, shall be rejected, except that when the infestation is slight and the nodules and larvae are removed, the casing or weasand may be passed." 9:9:2.0.2.1.19.1.7.6,9,Animals and Animal Products,III,A,318,PART 318—ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND PREPARATION OF PRODUCTS,A,Subpart A—General,,§ 318.6 Requirements concerning ingredients and other articles used in preparation of products.,FSIS,,,"[35 FR 15586, Oct. 3, 1970, as amended at 38 FR 14368, June 1, 1973; 38 FR 29214, Oct. 23, 1973; 39 FR 1973, Jan. 16, 1974; 41 FR 23702, June 11, 1976; 49 FR 19623, May 9, 1984; 50 FR 6, Jan. 2, 1985; 60 FR 55982, Nov. 3, 1995; 69 FR 1874, Jan. 12, 2004; 70 FR 53050, Sept. 7, 2005; 72 FR 38730, July 13, 2007]","(a) All ingredients and other articles used in the preparation of any product shall be clean, sound, healthful, wholesome, and otherwise such as will not result in the product being adulterated. Official establishments shall furnish inspectors accurate information on all procedures involved in product preparation including product composition and any changes in such procedures essential for inspectional control of the product. (b)(1) The only animal casings that may be used as containers of product are those from sheep, swine, or goats. Casings from cattle may be used as containers of products. However, if casings from cattle are derived from the small intestine, the small intestine must comply with the requirements in 9 CFR 310.22(d). Establishments that use casings derived from the small intestine of cattle as containers for products must demonstrate, through documentation, that the small intestine from which the casing was derived complies with the requirements in 9 CFR 310.22(d). (2) Casings for products shall be carefully inspected by Program employees. Only those casings which have been carefully washed and thoroughly flushed with clean water immediately before stuffing and are suitable for containers, are clean, and are passed on such inspection shall be used, except that preflushed animal casings packed in salt or salt and glycerine solution or other approved medium may be used without additional flushing provided they are found to be clean and otherwise acceptable and are thoroughly rinsed before use. (3) Hog and sheep casings intended for use as containers of product may be treated by soaking in or applying thereto sound, fresh pineapple juice or papain or bromelin or pancreatic extract to permit the enzymes contained in these substances to act on the casings to make them less resistant. The casings shall be handled in a clean and sanitary manner throughout and the treatment shall be followed by washing and flushing the casings with water sufficiently to effectively remove the substance used and terminate the enzymatic action. (4) On account of the invariable presence of bone splinters, detached spinal cords shall not be used in the preparation of edible product other than for rendering where they constitute a suitable raw material. Detached spinal cords from cattle 30 months of age and older shall not be used as raw materials for edible rendering. (5) Testicles if handled as an edible product may be shipped from the official establishment as such, but they shall not be used as an ingredient of a meat food product. (6) Tonsils shall be removed and shall not be used as ingredients of meat food products. (7) Blood from livestock prepared in accordance with § 310.20 of this subchapter may be used as an ingredient of a meat food product for which a standard is prescribed in part 319 of this subchapter, if permitted by such standard, and may be used in any meat food product for which no such standard is prescribed in part 319 of this subchapter if it is a common and usual ingredient of such product. (8) Intestines shall not be used as ingredients in any meat food product for which a standard is prescribed in part 319 of this subchapter and shall not be used in other products unless the products are labeled in accordance with § 317.8(b)(3) of this subchapter. When small intestine from cattle is used in a meat food product or for edible rendering, it must comply with the requirements in 9 CFR 310.22(d). (9) Poultry products and egg products (other than shell eggs) which are intended for use as ingredients of meat food products shall be considered acceptable for such use only when identified as having been inspected and passed for wholesomeness by the Department under the regulations in 7 CFR part 59 or 9 CFR part 362 or 381 and when found to be sound and otherwise acceptable when presented for use. Poultry products and egg products (other than shell eggs) which have not been so inspected and passed for wholesomeness shall not be used in the preparation of such meat food products. (10) Dry milk products which are intended for use as ingredients of meat food products shall be considered acceptable for such use only when produced in a plant approved by the Department under the regulations in 7 CFR part 58, and when found to be sound and otherwise acceptable when presented for use. Dry milk products prepared in a plant not so approved shall not be used in the preparation of such meat food products. (11) [Reserved] (12) Ingredients for use in any product may not bear or contain any pesticide chemical or other residues in excess of level permitted in § 318.16. (13) Use of “Mechanically Separated (Kind of Poultry),” as defined in § 381.173 of this chapter, in the preparation of meat food products shall accord with § 381.174 and all other applicable provisions of this subchapter." 9:9:2.0.2.1.19.1.7.7,9,Animals and Animal Products,III,A,318,PART 318—ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND PREPARATION OF PRODUCTS,A,Subpart A—General,,§ 318.8 Preservatives and other substances permitted in product for export only; handling; such product not to be used for domestic food purposes.,FSIS,,,"[35 FR 15586, Oct. 3, 1970; 36 FR 11903, June 23, 1971, as amended at 38 FR 29214, Oct. 23, 1973]","(a) Preservatives and other substances not permitted in domestic product under the regulations in this subchapter may be used in the preparation and packing of product intended for export provided the product (1) accords to the specifications or directions of the foreign purchaser; (2) is not in conflict with the laws of the country to which it is intended for export; and (3) is labeled on the outside container to show that it is intended for export, and is otherwise labeled as required by this subchapter for such export product. (b) The preparation and packing of export product as provided for in paragraph (a) of this section shall be done in a manner acceptable to the inspector in charge so that the identity of the export product is maintained conclusively and the preparation of domestic product is adequately protected. The preservatives and other substances not permitted in domestic product shall be stored in a room or compartment separate from areas used to store other supplies and shall be held under Program lock. Use of the preservatives or other substances shall be under the direct supervision of a Program employee. (c) The packing of all articles under paragraph (a) of this section shall be conducted under the direct supervision of a Program employee. (d) No article prepared or packed for export under paragraph (a) of this section shall be sold or offered for sale for domestic use or consumption, but unless exported shall be destroyed for food purposes under the direct supervision of a Program employee. (e) The contents of the container of any article prepared or packed for export under paragraph (a) of this section shall not be removed, in whole or in part, from such container prior to exportation, except under the supervision of a Program employee. If such contents are removed prior to exportation, then the article shall be either repacked, in accordance with the provisions of paragraphs (b) and (c) of this section, or destroyed for food purposes under the direct supervision of a Program employee. (f) Permission must be obtained from the Administrator before meats packed in borax are shipped from one official establishment to another or to an unofficial establishment for storage, except such meat prepared for the account of Federal agencies. (g) At all times, the identity of meat to which borax has been added shall be effectively maintained. In no case shall such meat, nor any trimmings or fat derived from such meat, whether unwashed or washed, or otherwise treated, be diverted to domestic use. (h) Salt used for bulking meat previously packed in borax may not again be used in an edible products department other than in connection with the packing of meat in borax. Only metal equipment should be used for handling such meat. Particularly effective cleansing will be required if wooden equipment such as trucks, washing vats, etc., is used. Boxes from which boraxed meat has been removed may be used for repacking meat in borax, but their use as containers for other meat will be dependent upon the effective removal of all traces of borax. (i) The following instructions pertain to export cured pork packed in borax for the account of Federal agencies. The meat may be packed in borax in a room in which there is borax-free meat, provided proper care is taken to see that the borax-free meat is not affected by the borax. Under the same condition, meat packed in borax may be received, unpacked, defrosted, soaked, washed, smoked, and repacked in a room where there is other meat. However, meat originally packed in borax shall at all times be subject to the restrictions of meat so packed, even though repacked without borax. After packing or repacking, borax packed meat may be stored in a room with meat not packed in borax, provided a reasonable degree of separation is maintained between the two classes of product." 9:9:2.0.2.1.19.1.7.8,9,Animals and Animal Products,III,A,318,PART 318—ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND PREPARATION OF PRODUCTS,A,Subpart A—General,,"§ 318.9 Samples of products, water, dyes, chemicals, etc., to be taken for examination.",FSIS,,,,"Samples of products, water, dyes, chemicals, preservatives, spices, or other articles in any official establishment shall be taken, without cost to the Program, for examination, as often as may be deemed necessary for the efficient conduct of the inspection." 9:9:2.0.2.1.19.1.7.9,9,Animals and Animal Products,III,A,318,PART 318—ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND PREPARATION OF PRODUCTS,A,Subpart A—General,,§ 318.10 [Reserved],FSIS,,,,