As used in this part, the following terms shall have the meanings set forth in this section.

Administrator. The Administrator, Animal and Plant Health Inspection Service, or any person authorized to act for the Administrator.

Animal and Plant Health Inspection Service. The Animal and Plant Health Inspection Service, of the United States Department of Agriculture (APHIS.)

APHIS-defined European CSF region. A single region of Europe recognized by APHIS as low risk for classical swine fever.

(1) A list of areas included in the region is maintained on the APHIS website at https://www.aphis.usda.gov/animalhealth/disease-status-of-regions. Copies of the list are also available via postal mail or email upon request to Regionalization Evaluation Services, Strategy and Policy, Veterinary Services, Animal and Plant Health Inspection Service, 4700 River Road, Unit 38, Riverdale, Maryland 20737; [email protected].

(2) APHIS will add an area to the region after it conducts an evaluation of the area to be added in accordance with § 92.2 of this subchapter and finds that the risk profile for the area is equivalent with respect to classical swine fever to the risk profile for the region it is joining.

APHIS-defined European Poultry Trade Region. A single region consisting of Austria, Belgium, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Great Britain (England, Scotland, and Wales), Greece, Hungary, Ireland (Republic of), Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Northern Ireland, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, and Sweden.

APHIS representative. An individual employed by Animal and Plant Health Inspection Service, United States Department of Agriculture, who is authorized to perform the function involved.

Approved establishment means an establishment authorized by Veterinary Services for the receipt and handling of restricted imported animal carcasses, products, and byproducts.

Authorized inspector. Any individual authorized by the Administrator of APHIS or the Commissioner of Customs and Border Protection, Department of Homeland Security, to enforce the regulations in this part.

Birds. All members of the class Aves (other than poultry or game birds).

Bovine. Bos taurus, Bos indicus, and Bison bison.

Bovine spongiform encephalopathy (BSE) minimal-risk region. A region that:

(1) Maintains, and, in the case of regions where BSE was detected, had in place prior to the detection of BSE in an indigenous ruminant, risk mitigation measures adequate to prevent widespread exposure and/or establishment of the disease. Such measures include the following:

(i) Restrictions on the importation of animals sufficient to minimize the possibility of infected ruminants being imported into the region, and on the importation of animal products and animal feed containing ruminant protein sufficient to minimize the possibility of ruminants in the region being exposed to BSE;

(ii) Surveillance for BSE at levels that meet or exceed recommendations of the World Organization for Animal Health (Office International des Epizooties) for surveillance for BSE; and

(iii) A ruminant-to-ruminant feed ban that is in place and is effectively enforced.

(2) In regions where BSE was detected, conducted an epidemiological investigation following detection of BSE sufficient to confirm the adequacy of measures to prevent the further introduction or spread of BSE, and continues to take such measures.

(3) In regions where BSE was detected, took additional risk mitigation measures, as necessary, following the BSE outbreak based on risk analysis of the outbreak, and continues to take such measures.

Cold spot. The area in a flexible plastic cooking tube or other type of container loaded with meat product, or the areas at various points along the belt in an oven chamber, slowest to reach the required temperature during the cooking process. The cold spot(s) for each container is experimentally determined before the cooking process begins, and once identified, remains constant.

Commercial birds. Birds that are imported for resale, breeding, public display, or any other purpose, except pet birds, zoological birds, research birds, or performing or theatrical birds.

Commercial poultry. Chickens, doves, ducks, geese, grouse, guinea fowl, partridges, pea fowl, pheasants, pigeons, quail, swans, and turkeys (including eggs for hatching) which are imported for resale, breeding, public display, or any other commercial purpose.

Contact. Known or potential commingling of products during processing or storage, or while being transported from any point to any other point. Contact includes the simultaneous processing in the same room, locker, or container, but not necessarily the same storage facility or conveyance, as long as adequate security measures are taken to prevent commingling, as determined by an authorized APHIS representative.

Container. For the purposes of § 94.1(c) and § 94.16(c), this term means a receptacle, sometimes refrigerated, which is designed to be filled with cargo, sealed, and then moved, without unsealing or unloading, aboard a variety of different transporting carriers.

Department. The United States Department of Agriculture (USDA, Department).

Direct transloading. The transfer of cargo directly from one means of conveyance to another.

Exporting region. A region from which shipments are sent to the United States.

Farm equipment. Equipment used in the production of livestock or crops, including, but not limited to, mowers, harvesters, loaders, slaughter machinery, agricultural tractors, farm engines, farm trailers, farm carts, and farm wagons, but excluding automobiles and trucks.

Flock of origin. The flock in which the eggs were produced.

Food Safety and Inspection Service. The Food Safety and Inspection Service (FSIS) of the United States Department of Agriculture.

FSIS inspector. An individual authorized by the Administrator, Food Safety and Inspection Service, United States Department of Agriculture, to perform the function involved.

Game birds. Migratory birds, including certain ducks, geese, pigeons, and doves (“migratory” refers to seasonal flight to and from the United States); free-flying quail, wild grouse, wild pheasants (as opposed to those that are commercial, domestic, or pen-raised).

Highly pathogenic avian influenza (HPAI). Highly pathogenic avian influenza is defined as follows:

(1) Any influenza virus that kills at least 75 percent of eight 4- to 6-week-old susceptible chickens within 10 days following intravenous inoculation with 0.2 mL of a 1:10 dilution of a bacteria-free, infectious allantoic fluid or inoculation of 10 susceptible 4- to 8-week-old chickens resulting in an intravenous pathogenicity index (IVPI) of greater than 1.2;

(2) Any H5 or H7 virus that does not meet the criteria in paragraph (1) of this definition, but has an amino acid sequence at the haemagglutinin cleavage site that is compatible with highly pathogenic avian influenza viruses; or

(3) Any influenza virus that is not an H5 or H7 subtype and that kills one to five out of eight inoculated chickens and grows in cell culture in the absence of trypsin within 10 days.

House. A structure, enclosed by walls and a roof, in which poultry are raised.

Immediate export. The period of time determined by APHIS, based on shipping routes and timetables, to be the shortest practicable interval of time between the arrival in the United States of an incoming carrier and the departure from the United States of an outgoing carrier, to transport a consignment of products.

Import (imported, importation) into the United States. To bring into the territorial limits of the United States.

Indicator piece. A cube or slice of meat to be used for the pink juice test, required to meet minimum size specifications.

Mechanically separated meat. A finely comminuted product resulting from the mechanical separation and removal of most of the bone from attached skeletal muscle of bovine carcasses that meets the FSIS specifications contained in 9 CFR 319.5.

Newcastle disease. Newcastle disease is an acute, rapidly spreading, and usually fatal viral infection of poultry caused by an avian paramyxovirus serotype 1 that meets one of the following criteria for virulence: The virus has an intracerebral pathogenicity index (ICPI) in day-old chicks (Gallus gallus) of 0.7 or greater; or multiple basic amino acids have been demonstrated in the virus (either directly or by deduction) at the C-terminus of the F2 protein and phenylalanine at residue 117, which is the N-terminus of the F1 protein. The term “multiple basic amino acids” refers to at least three arginine or lysine residues between residues 113 and 116. In this definition, amino acid residues are numbered from the N-terminus of the amino acid sequence deduced from the nucleotide sequence of the F0 gene; 113-116 corresponds to residues −4 to −1 from the cleavage site. Failure to demonstrate the characteristic pattern of amino acid residues as described above may require characterization of the isolated virus by an ICPI test. A failure to detect a cleavage site that is consistent with virulent strains does not confirm the absence of a virulent virus.

Operator. The operator responsible for the day-to-day operations of a facility.

Personal use. Only for personal consumption or display and not distributed further or sold.

Pink juice test. Determination of whether meat has been thoroughly cooked by observation of whether the flesh and juices have lost all red and pink color.

Port of arrival. Any place in the United States at which a product or article arrives, unless the product or article remains on the means of conveyance on which it arrived within the territorial limits of the United States.

Positive for a transmissible spongiform encephalopathy. A sheep or goat for which a diagnosis of a transmissible spongiform encephalopathy has been made.

Poultry. Chickens, turkeys, swans, partridges, guinea fowl, pea fowl; nonmigratory ducks, geese, pigeons, and doves; commercial, domestic, or pen-raised grouse, pheasants, and quail.

Processed animal protein. Meat meal, bone meal, meat-and-bone meal, blood meal, dried plasma and other blood products, hydrolyzed protein, hoof meal, horn meal, poultry meal, feather meal, fish meal, and any other similar products.

Premises of origin. The premises where the flock of origin is kept.

Region. Any defined geographic land area identifiable by geological, political, or surveyed boundaries. A region may consist of any of the following:

(1) A national entity (country);

(2) Part of a national entity (zone, county, department, municipality, parish, Province, State, etc.)

(3) Parts of several national entities combined into an area; or

(4) A group of national entities (countries) combined into a single area.

Region of origin. For meat and meat products, the region in which the animal from which the meat or meat products were derived was born, raised and slaughtered; and for eggs, the region in which the eggs were laid.

Restricted zone for classical swine fever. An area, delineated by the relevant competent veterinary authorities of the region in which the area is located, that surrounds and includes the location of an outbreak of classical swine fever in domestic swine or detection of the disease in wild boar, and from which the movement of domestic swine is prohibited.

Ruminants. All animals that chew the cud, such as cattle, buffaloes, sheep, goats, deer, antelopes, camels, llamas and giraffes.

Sentinel bird. A chicken that has been raised in an environment free of pathogens that cause communicable diseases of poultry and that has not been infected with, exposed to, or immunized with any strain of virus that causes Newcastle disease.

Specified risk materials (SRMs) from regions of controlled risk for BSE. Those bovine parts considered to be at particular risk of containing the BSE agent in infected animals, as listed in the FSIS regulations at 9 CFR 310.22(a).

Specified risk materials (SRMs) from regions of undetermined risk for BSE. Those bovine parts considered to be at particular risk of containing the BSE agent in infected animals, as listed in the FSIS regulations at 9 CFR 310.22(a), except that the following bovine parts from regions of undetermined risk for BSE are considered SRMs if they are derived from bovines over 12 months of age: Brain, skull, eyes, trigeminal ganglia, spinal cord, vertebral column (excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum), and the dorsal root ganglia.

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.

Suspect for a transmissible spongiform encephalopathy. (1) A sheep or goat that has tested positive for a transmissible spongiform encephalopathy or for the proteinase resistant protein associated with a transmissible spongiform encephalopathy, unless the animal is designated as positive for a transmissible spongiform encephalopathy; or

(2) A sheep or goat that exhibits any of the following signs and that has been determined to be suspicious for a transmissible spongiform encephalopathy by a veterinarian: Weight loss despite retention of appetite; behavior abnormalities; pruritus (itching); wool pulling; biting at legs or side; lip smacking; motor abnormalities such as incoordination, high stepping gait of forelimbs, bunny hop movement of rear legs, or swaying of back end; increased sensitivity to noise and sudden movement; tremor, “star gazing,” head pressing, recumbency, or other signs of neurological disease or chronic wasting.

Temperature indicator device (TID). A precalibrated temperature-measuring instrument containing a chemical compound activated at a specific temperature (the melting point of the chemical compound) identical to the processing temperature that must be reached by the meat being cooked. The Administrator will approve a TID for use after determining that the chemical compound in the device is activated at the specific temperature required.

Thoroughly cooked. Heated sufficiently to inactivate any pathogen that may be present, as indicated by the required TID or pink juice test.

United States. All of the States.

Veterinarian in Charge. The veterinary official of the Animal and Plant Health Inspection Service, United States Department of Agriculture, who is assigned by the Administrator to supervise and perform the official animal health work of the Animal and Plant Health Inspection Service in the State or area concerned.

Wild swine. Any swine which are allowed to roam outside an enclosure.

(a) APHIS considers foot-and-mouth disease to exist in all regions of the world except those declared free of the disease by APHIS.

(1) A list of regions that APHIS has declared free of foot-and-mouth disease is maintained on the APHIS website at https://www.aphis.usda.gov/animalhealth/disease-status-of-regions. Copies of the list can be obtained via postal mail upon request to Regionalization Evaluation Services, Strategy and Policy, Veterinary Services, Animal and Plant Health Inspection Service, 4700 River Road, Unit 38, Riverdale, Maryland 20737; [email protected].

(2) APHIS will add a region to the list of those it has declared free of foot-and-mouth disease after it conducts an evaluation of the region in accordance with § 92.2 of this subchapter and finds that the disease is not present. In the case of a region formerly on this list that is removed due to an outbreak, the region may be returned to the list in accordance with the procedures for reestablishment of a region's disease-free status in § 92.4 of this subchapter. APHIS will remove a region from the list of those it has declared free of foot-and-mouth disease upon determining that the disease exists in the region based on reports APHIS receives of outbreaks of the disease from veterinary officials of the exporting country, from the World Organization for Animal Health (OIE), or from other sources the Administrator determines to be reliable.

(b) The importation of any ruminant or swine or any fresh (chilled or frozen) meat of any ruminant or swine 1 that originates in any region where foot-and-mouth disease exists, as designated in paragraph (a) of this section, or that enters a port in or otherwise transits a region in which foot-and-mouth disease exists, is prohibited:

(1) Except as provided in part 93 of this chapter for wild ruminants and wild swine;

(2) Except as provided in paragraph (d) of this section for fresh (chilled or frozen) meat of ruminants or swine that is otherwise eligible for importation under this part but that enters a port or otherwise transits a region where foot-and-mouth disease exists; and

(3) Except as provided in § 94.4 of this part for cooked or cured meat from regions where foot-and-mouth disease exists.

(4) Except as provided in § 94.29 for fresh (chilled or frozen) beef and ovine meat.

(c) The importation of any used farm equipment that originates in any region where foot-and-mouth disease exists, as designated in paragraph (a) of this section, is prohibited, unless the equipment is accompanied by an original certificate signed by an authorized official of the national animal health service of the exporting region that states that the equipment, after its last use and prior to export, was steam-cleaned free of all exposed dirt and other particulate matter. Such farm equipment is subject to APHIS inspection at the port of arrival. If it is found during such inspection to contain any exposed dirt or other particulate matter, it will be denied entry into the United States, unless, in the judgment of the APHIS inspector, the amount of exposed soil is minimal enough to allow cleaning at the port of arrival, and there are adequate facilities and personnel at the port to conduct such cleaning without risk of disease contamination.

(d) Except as otherwise provided in this part, fresh (chilled or frozen) meat of ruminants or swine raised and slaughtered in a region free of foot-and-mouth disease, as designated in paragraph (a) of this section, and fresh (chilled or frozen) beef and ovine meat exported in accordance with § 94.29, which during shipment to the United States enters a port or otherwise transits a region where foot-and-mouth disease exists, may be imported provided that all of the following conditions are met:

(1) The meat is accompanied by the foreign meat inspection certificate required by § 327.4 of this title and, upon arrival of the meat in the United States, the foreign meat inspection certificate is presented to an authorized inspector at the port of arrival;

(2) The meat is placed in the transporting carrier in a hold, compartment, or, if the meat is containerized, in a container that which was sealed in the region of origin by an official of such region with serially numbered seals approved by APHIS, so as to prevent contact of the meat with any other cargo, handling of the meat after the hold, compartment, or container is sealed, and the loading of any cargo into and the removal of any cargo from the sealed hold, compartment, or container en route to the United States;

(3) If any foreign official breaks a seal applied in the region of origin in order to inspect the meat, he or she then reseals the hold, compartment, or container with a new serially numbered seal; and, if any member of a ship's crew breaks a seal, the serial number of the seal, the location of the seal, and the reason for breaking the seal are recorded in the ship's log.

(4) The serial numbers of the seals used to seal the hold, compartment, or container are recorded on the foreign meat inspection certificate which accompanies the meat;

(5) Upon arrival of the carrier in the United States port of arrival, the seals are found by an APHIS representative to be intact, and the representative finds that there is no evidence indicating that any seal has been tampered with; Provided that, if the representative finds that any seal has been broken or has a different number than is recorded on the foreign meat inspection certificate, then the meat may remain eligible for entry into the United States only if APHIS personnel are available to inspect the hold, compartment, or container, the packages of meat, and all accompanying documentation; and the importer furnishes additional documentation (either copies of pages from the ship's log signed by the officer-in-charge, or certification from a foreign government that the original seal was removed and the new seal applied by officials of that government) that demonstrates to the satisfaction of the Administrator that the meat was not contaminated or exposed to contamination during movement from the region of origin to the United States; and

(6) The meat is found by an authorized inspector to be as represented on the foreign meat inspection certificate.

(a) The importation of fresh (chilled or frozen) products (other than meat and milk and milk products) derived from ruminants or swine, originating in, shipped from, or transiting any region designated in § 94.1(a) as a region affected with foot-and-mouth disease is prohibited, except as provided in § 94.3 and parts 95 and 96 of this chapter.

(b) The importation of milk and milk products of ruminants and swine originating in, shipped from, or transiting any region designated in § 94.1(a) as a region affected with foot-and-mouth disease is prohibited, except as provided in § 94.16.

The importation of fresh (chilled or frozen) organs, glands, extracts, or secretions derived from ruminants or swine, originating in any region where foot-and-mouth disease exists, as designated in § 94.1, except for pharmaceutical or biological purposes under conditions prescribed by the Administrator in each instance, is prohibited.

(a) The importation of cured meats derived from ruminants or swine, originating in any region where foot-and-mouth disease exists, as designated in § 94.1, is prohibited unless the following conditions have been fulfilled:

(1) All bones shall have been completely removed in the region of origin.

(2) The meat shall have been held in an unfrozen, fresh condition for at least 3 days immediately following the slaughter of the animals from which it was derived.

(3)(i) The meat shall have been thoroughly cured and fully dried in such manner that it may be stored and handled without refrigeration, as in the case of salami and other summer sausages, tasajo, xarque, or jerked beef, bouillon cubes, dried beef, and Westphalia, Italian and similar type hams. The term “fully dried” as used in this paragraph means dried to the extent that the water-protein ratio in the wettest portion of the product does not exceed 2.25 to 1.

(ii) Laboratory analysis of samples to determine the water-protein ratios will not be made in the case of all shipments of cured and dried meats. However, in any case in which the inspector is uncertain whether the meat complies with the requirements of paragraph (a)(3)(i) of this section, he will send a sample of the meat representative of the wettest portion to the Meat Inspection Division for analysis of the water-protein ratio. Pending such analysis the meat shall not be released or removed from the port of arrival.

(4) The cured meat shall be accompanied by a certificate issued by an official of the national government of the region of origin who is authorized to issue the foreign meat inspection certificate required by § 327.4 of this title, stating that such meat has been prepared in accordance with paragraphs (a)(1), (a)(2) and (a)(3)(i) of this section. Upon arrival of the cured meat in the United States, the certificate must be presented to an authorized inspector at the port of arrival.

(b) The importation of cooked meats from ruminants or swine originating in any region where foot-and-mouth disease exists, as designated in § 94.1, is prohibited, except as provided in this section.

(1) The cooked meat must be boneless and must be thoroughly cooked.

(2) The cooked meat must have been prepared in an establishment that is eligible to have its products imported into the United States under the Federal Meat Inspection Act (21 U.S.C. 601 et seq.) and the regulations in 9 CFR 327.2; must meet all other applicable requirements of the Federal Meat Inspection Act and regulations thereunder (9 CFR Chapter III); and must have been approved by the Administrator in accordance with paragraph (c) of this section.

(3) Canned product (canned meat), as defined in part 431 of this title, is exempt from the requirements in this section.

(4) Ground meat cooked in an oven. Ground meat must be shaped into patties no larger than 5 inches in diameter and 1-inch thick. Each patty must weigh no more than 115 grams, with fat content no greater than 30 percent. These patties must be broiled at 210 °C for at least 133 seconds, then cooked in moist heat (steam heat) in a continuous, belt-fed oven for not less than 20 minutes, to yield an internal exit temperature of at least 99.7 °C, as measured by temperature indicator devices (TID's) placed in temperature monitor patties positioned, before the belt starts moving through the oven, on each of the predetermined cold spots along the oven belt. TID's must be used at the beginning of each processing run.

(5) Meat cooked in tubes. Ground meat (which must not include cardiac muscle), cubes of meat, slices of meat, or anatomical cuts of meat (cuts taken from the skeletal muscle tissue) weighing no more than 5 kg (11.05 lbs) must be loaded into a flexible or semiflexible cooking tube constructed of plastic or other material approved by the U.S. Food and Drug Administration. The meat must then be cooked in either boiling water or in a steam-fed oven, in either a batch cooker or a continuous cooker, to reach a minimum internal temperature of 79.4 °C (175 °F) at the cold spot after cooking for at least 1.75 hours. Thoroughness of cooking must be determined by a TID registering the target temperature at the cold spot, or by the pink juice test as follows:

(i) Cubes of meat and ground meat. For cubes of meat, at least 50 percent of meat pieces per tube must be 3.8 cm (1.5 in) or larger in each dimension after cooking or, if more than 50 percent of the cubes of meat pieces per tube are smaller than 3.8 cm (1.5 in) in any dimension after cooking, or if the meat is ground meat, an indicator piece consisting of a single piece of meat of sufficient size for a pink juice test to be performed (3.8 cm (1.5 in) or larger in each dimension after cooking) must have been placed at the cold spot of the tube.

(ii) Slices of meat. At least 50 percent of the slices of meat must be 3.8 cm (1.5 in) or larger in each dimension after cooking or, if more than 50 percent of meat pieces are smaller than 3.8 cm (1.5 in) in any dimension after cooking, an indicator piece of sufficient size for a pink juice test to be performed (3.8 cm (1.5 in) or larger in each dimension after cooking) must be placed at the cold spot of the tube.

(iii) Anatomical cuts of meat. An indicator piece removed from an anatomical cut of meat after cooking must be removed from the center of the cut, farthest from all exterior points and be 3.8 cm (1.5 in) or larger in each dimension for performance of the pink juice test.

(6) Further processing of meat cooked in tubes. Cubes of meat, slices of meat, or anatomical cuts of meat (cuts taken from the skeletal muscle tissue) cooked in tubes in accordance with paragraph (b)(5) of this section may be processed further after cooking if the following provisions are met:

(i) For meat that is cooked and is intended for further processing, up to two tubes from each batch per cooker must be randomly selected by the official of the National Government of the region of origin who is authorized to issue the meat inspection certificate required by § 327.4 of this title. If a TID is not used, a cylindrical or square piece of at least 3.8 cm (1.5 in) in each dimension must be cut from the cold spot of each tube. The cylindrical or square piece will be the indicator piece for the pink juice test. The indicator piece or piece containing the TID must be sealed in plastic or other material approved by the U.S. Food and Drug Administration, and be accompanied by a certificate issued by the official who selected the tube. The certificate must provide the date the tube was cooked and the cooker and batch number, and the date the tube was selected for sampling. Each batch per cooker must have at least one but no more than two indicator pieces or pieces containing TID's. All indicator pieces and pieces containing TID's must be individually sealed, properly labeled, and enclosed together in one sealed box that accompanies the shipment. Any indicator pieces or pieces containing TID's that are not used to accompany a shipment to the United States must be destroyed following loading of the batch into a container; and

(ii) After removing the indicator piece or piece containing a TID, all remaining meat from the same batch may be cut into smaller cubes and sealed in plastic or other material approved by the U.S. Food and Drug Administration. After being processed into smaller cubes once, the meat may not be further processed before shipment to the United States. The cubes of meat and the indicator piece or piece containing a TID must be accompanied to the United States by a certificate as provided in paragraph (b)(8) of this section.

(7) Any TID used in accordance with paragraph (b)(4) or (b)(5) of this section must remain in the meat, as originally inserted, and must accompany the cooked meat whose temperature it has gauged when that meat is shipped to the United States.

(8) Pork rind pellets (pork skins). Pork rind pellets (pork skins) must be cooked in one of the following ways:

(i) One-step process. The pork skins must be cooked in oil for at least 80 minutes when oil temperature is consistently maintained at a minimum of 114 °C.

(ii) Two-step process. The pork skins must be dry-cooked at 260 °C for approximately 210 minutes after which they must be cooked in hot oil (deep-fried) at 104 °C for an additional 150 minutes.

(9) Certificate. (i) The cooked meat must be accompanied by a certificate issued by an official of the National Government of the region of origin who is authorized to issue the foreign meat inspection certificate required under § 327.4 of this title, stating: “This cooked meat produced for export to the United States meets the requirements of title 9, Code of Federal Regulations, § 94.4(b).” Upon arrival of the cooked meat in the United States, the certificate must be presented to an authorized inspector at the port of arrival.

(ii) For cooked meat that is further processed in accordance with paragraph (b)(6) of this section, the certificate must include the following statement, in addition to the certification required under paragraph (b)(9)(i) of this section: “No more than two tubes were randomly selected per batch per cooker for cutting an indicator piece or obtaining a piece containing a TID. The indicator piece or piece containing a TID represents a shipment of (describe form of processed product—e.g., diced cubes of a particular size). A piece containing a TID or a piece 3.8 cm (1.5 in) or larger in each dimension was cut from the cold spot of the tube, and was sealed and marked with the following cooking date, cooker, and batch: __________ and the following date of selection of the tube__________. The total number of indicator pieces or pieces containing TID's enclosed in a sealed box is__________.”

(10) The meat is inspected by an FSIS inspector at a port of arrival in a defrost facility approved by the Administrator 2 and the meat is found to be thoroughly cooked.

(i) Request for approval of any defrost facility must be made to the Administrator. The Administrator will approve a defrost facility only under the following conditions:

(A) The defrost facility has equipment and procedures that permit FSIS inspectors to determine whether meat is thoroughly cooked;

(B) The defrost facility is located at a port of arrival; and

(C) The defrost facility is approved by the Food Safety and Inspection Service, United States Department of Agriculture. 3

(ii) The Administrator may deny approval of any defrost facility if the Administrator determines that the defrost facility does not meet the conditions for approval. If approval is denied, the operator of the defrost facility will be informed of the reasons for denial and be given an opportunity to respond. The operator will be afforded an opportunity for a hearing with respect to any disputed issues of fact. The hearing will be conducted in accordance with rules of practice that will be adopted for the proceeding.

(iii) The Administrator may withdraw approval of any defrost facility as follows: (A) When the operator of the defrost facility notifies the Administrator in writing that the defrost facility no longer performs the required services; or (B) when the Administrator determines that the defrost facility does not meet the conditions for approval. Before the Administrator withdraws approval from any defrost facility, the operator of the defrost facility will be informed of the reasons for the proposed withdrawal and given an opportunity to respond. The operator will be afforded a hearing with respect to any disputed issues of fact. The hearing will be conducted in accordance with rules of practice that will be adopted for the proceeding. If approval of a defrost facility is withdrawn, the Administrator will remove its name from the list of approved defrost facilities.

(c) Meat processing establishment; standards. (1) Before the Administrator will approve a meat processing establishment for export shipment of cooked meat to the United States, the Administrator must determine:

(i) That the meat processing establishment has furnished APHIS with a description of the process used to inactivate FMD virus that may be present in meat intended for export to the United States, and with blueprints of the facilities where this meat is cooked and packaged;

(ii) That an APHIS representative has inspected the establishment and found that it meets the standards set forth in paragraph (c)(2) of this section;

(iii) That the operator of the establishment has signed a cooperative service agreement with APHIS, stating:

(A) That all cooked meat processed for importation into the United States will be processed in accordance with the requirements of this part;

(B) that a full-time, salaried meat inspection official of the National Government of the exporting region will supervise the processing (including certification of the cold spot) and examination of the product, and certify that it has been processed in accordance with this section; and

(C) that APHIS personnel or other persons authorized by the Administrator may enter the establishment, unannounced, to inspect the establishment and its records; and

(iv) That the operator of the establishment has entered into a trust fund agreement with APHIS and is current in paying all costs for an APHIS representative to inspect the establishment for initial evaluation, and periodically thereafter, including travel, salary, subsistence, administrative overhead, and other incidental expenses (including an excess baggage provision up to 150 pounds). In accordance with the terms of the trust fund agreement, before the APHIS representative's site inspection, the operator of the processing establishment must deposit with the Administrator an amount equal to the approximate cost of one inspection by an APHIS representative, including travel, salary, subsistence, administrative overhead, and other incidental expenses (including an excess baggage provision up to 150 pounds). As funds from that amount are obligated, a bill for costs incurred based on official accounting records will be issued, to restore the deposit to the original level, revised as necessary to allow for inflation or other changes in estimated costs. To be current, bills must be paid within 14 days of receipt.

(2) Establishment. An APHIS representative will conduct an on-site evaluation, and subsequent inspections, as provided in § 94.4(c)(1), to determine whether the following conditions are met:

(i) The facilities used for processing cooked meat in the meat processing establishment are separate from the facilities used for processing raw meat (precooking, boning, preparation, and curing), with only the through-the-wall cooking system through which the meat product is delivered at the end of the cooking cycle connecting them; and there is at all times a positive air flow from the cooked to the raw product side;

(ii) The cooking equipment has the capacity to cook all meat pieces in accordance with § 94.4(b)(4) or (b)(5);

(iii) Workers who process cooked meat are at all times kept separate from workers who process raw meat, and have, for their exclusive use: A separate entrance, dining area, toilets, lavatories with cold and hot water, soap, disinfectants, paper towels, clothes hampers and waste baskets for disposal, and changing rooms stocked with the clean clothing and rubber boots into which all persons must change upon entering the establishment. Workers and all other persons entering the establishment must wash their hands and change into the clean clothing and boots provided in the changing rooms before entering the cooking facilities, and must leave this clothing for laundering and disinfecting before exiting from the establishment, regardless of the amount of time spent inside or away from the establishment;

(iv) Original records identifying the slaughtering facility from which the meat was obtained and the date the meat entered the meat processing establishment, and original certification (including temperature recording charts and graphs), must be kept for all cooked meat by the full-time salaried meat inspection official of the National Government of the exporting region assigned to the establishment, and must be retained for 2 years.

(a) General restrictions—(1) Interstate movements of garbage from Hawaii and U.S. territories and possessions to the continental United States. Hawaii, Puerto Rico, American Samoa, the Commonwealth of the Northern Mariana Islands, the Federated States of Micronesia, Guam, the U.S. Virgin Islands, Republic of the Marshall Islands, and the Republic of Palau are hereby quarantined, and the movement of garbage therefrom to any other State is hereby prohibited except as provided in this section in order to prevent the introduction and spread of exotic plant pests and diseases.

(2) Imports of garbage. In order to protect against the introduction of exotic animal and plant pests, the importation of garbage from all foreign countries except Canada is prohibited except as provided in paragraph (c)(2) of this section.

(b) Definitions—Agricultural waste. Byproducts generated by the rearing of animals and the production and harvest of crops or trees. Animal waste, a large component of agricultural waste, includes waste (e.g., feed waste, bedding and litter, and feedlot and paddock runoff) from livestock, dairy, and other animal-related agricultural and farming practices.

Approved facility. A facility approved by the Administrator, Animal and Plant Health Inspection Service, upon his determination that it has equipment and uses procedures that are adequate to prevent the dissemination of plant pests and livestock or poultry diseases, and that it is certified by an appropriate Government official as currently complying with the applicable laws for environmental protection.

Approved sewage system. A sewage system approved by the Administrator, Animal and Plant Health Inspection Service, upon his determination that the system is designed and operated in such a way as to preclude the discharge of sewage effluents onto land surfaces or into lagoons or other stationary waters, and otherwise is adequate to prevent the dissemination of plant pests and livestock or poultry diseases, and that is certified by an appropriate Government official as currently complying with the applicable laws for environmental protection.

Carrier. The principal operator of a means of conveyance.

Continental United States. The 49 States located on the continent of North America and the District of Columbia.

Garbage. All waste material that is derived in whole or in part from fruits, vegetables, meats, or other plant or animal (including poultry) material, and other refuse of any character whatsoever that has been associated with any such material.

Incineration. To reduce garbage to ash by burning.

Inspector. A properly identified employee of the U.S. Department of Agriculture or other person authorized by the Department to enforce the provisions of applicable statutes, quarantines, and regulations.

Interstate. From one State into or through any other State.

Person. Any individual, corporation, company, association, firm, partnership, society, or joint stock company.

Shelf-stable. The condition achieved in a product, by application of heat, alone or in combination with other ingredients and/or other treatments, of being rendered free of microorganisms capable of growing in the product under nonrefrigerated conditions (over 50 °F or 10 °C).

Sterilization. Cooking garbage at an internal temperature of 212 °F for 30 minutes.

Stores. The food, supplies, and other provisions carried for the day-to-day operation of a conveyance and the care and feeding of its operators.

Yard waste. Solid waste composed predominantly of grass clippings, leaves, twigs, branches, and other garden refuse.

(c) Garbage generated onboard a conveyance—(1) Applicability. This section applies to garbage generated onboard any means of conveyance during international or interstate movements as provided in this section and includes food scraps, table refuse, galley refuse, food wrappers or packaging materials, and other waste material from stores, food preparation areas, passengers' or crews' quarters, dining rooms, or any other areas on the means of conveyance. This section also applies to meals and other food that were available for consumption by passengers and crew on an aircraft but were not consumed.

(i) Not all garbage generated onboard a means of conveyance is regulated for the purposes of this section. Garbage regulated for the purposes of this section is defined as “regulated garbage” in paragraphs (c)(2) and (c)(3) of this section.

(ii) Garbage that is commingled with regulated garbage is also regulated garbage.

(2) Garbage regulated because of movements outside the United States or Canada. For purposes of this section, garbage on or removed from a means of conveyance is regulated garbage, if, when the garbage is on or removed from the means of conveyance, the means of conveyance has been in any port outside the United States and Canada within the previous 2-year period. There are, however, two exceptions to this provision. These exceptions are as follows:

(i) Exception 1: Aircraft. Garbage on or removed from an aircraft is exempt from requirements under paragraph (c)(4) of this section if the following conditions are met when the garbage is on or removed from the aircraft:

(A) The aircraft had previously been cleared of all garbage and of all meats and meat products, whatever the country of origin, except meats that are shelf-stable; all fresh and condensed milk and cream from countries designated in § 94.1 as those in which foot-and-mouth disease exists; all fresh fruits and vegetables; and all eggs; and the items previously cleared from the aircraft as prescribed by this paragraph have been disposed of according to the procedures for disposing of regulated garbage, as specified in paragraphs (c)(4)(ii) and (c)(4)(iii) of this section.

(B) After the garbage and stores referred to in paragraph (c)(2)(i)(A) of this section were removed, the aircraft has not been in a non-Canadian foreign port.

(ii) Exception 2: Other conveyances. Garbage on or removed in the United States from a means of conveyance other than an aircraft is exempt from requirements under paragraph (c)(4) of this section if the following conditions are met when the garbage is on or removed from the means of conveyance:

(A) The means of conveyance is accompanied by a certificate from an inspector stating the following:

(1) That the means of conveyance had previously been cleared of all garbage and of all meats and meat products, whatever the country of origin, except meats that are shelf-stable; all fresh and condensed milk and cream from countries designated in § 94.1 as those in which foot-and-mouth disease exists; all fresh fruits and vegetables; and all eggs; and the items previously cleared from the means of conveyance as prescribed by this paragraph have been disposed of according to the procedures for disposing of regulated garbage, as specified in paragraphs (c)(4)(ii) and (c)(4)(iii) of this section.

(2) That the means of conveyance had then been cleaned and disinfected in the presence of the inspector; and

(B) Since being cleaned and disinfected, the means of conveyance has not been in a non-Canadian foreign port.

(3) Garbage regulated because of certain movements to or from Hawaii, territories, or possessions. For purposes of this section, garbage on or removed from a means of conveyance is regulated garbage, if at the time the garbage is on or removed from the means of conveyance, the means of conveyance has moved during the previous 1-year period, either directly or indirectly, to the continental United States from any territory or possession or from Hawaii, to any territory or possession from any other territory or possession or from Hawaii, or to Hawaii from any territory or possession. There are, however, two exceptions to this provision. These exceptions are as follows:

(i) Exception 1: Aircraft. Garbage on or removed from an aircraft is exempt from requirements under paragraph (c)(4) of this section if the following two conditions are met when the garbage is on or removed from the aircraft:

(A) The aircraft had been previously cleared of all garbage and all fresh fruits and vegetables, and the items previously cleared from the aircraft as prescribed by this paragraph have been disposed of according to the procedures for disposing of regulated garbage, as specified in paragraphs (c)(4)(ii) and (c)(4)(iii) of this section.

(B) After the garbage and stores referred to in paragraph (c)(3)(i)(A) of this section were removed, the aircraft has not moved to the continental United States from any territory or possession or from Hawaii, to any territory or possession from any other territory or possession or from Hawaii, or to Hawaii from any territory or possession.

(ii) Exception 2: Other conveyances. Garbage on or removed from a means of conveyance other than an aircraft is exempt from requirements under paragraph (c)(4) of this section if the following two conditions are met when the garbage is on or removed from the means of conveyance:

(A) The means of conveyance is accompanied by a certificate from an inspector stating that the means of conveyance had been cleared of all garbage and all fresh fruits and vegetables, and the items previously cleared from the means of conveyance as prescribed by this paragraph have been disposed of according to the procedures for disposing of regulated garbage, as specified in paragraphs (c)(4)(ii) and (c)(4)(iii) of this section.

(B) After being cleared of the garbage and stores referred to in paragraph (c)(3)(ii)(A) of this section, the means of conveyance has not moved to the continental United States from any territory or possession or from Hawaii; to any territory or possession from any other territory or possession or from Hawaii; or to Hawaii from any territory or possession.

(4) Restrictions on regulated garbage. (i) Regulated garbage may not be disposed of, placed on, or removed from a means of conveyance except in accordance with this section.

(ii) Regulated garbage is subject to general surveillance for compliance with this section by inspectors and to disposal measures authorized by the Plant Protection Act and the Animal Health Protection Act to prevent the introduction and dissemination of pests and diseases of plants and livestock.

(iii) All regulated garbage must be contained in tight, covered, leak-proof receptacles during storage on board a means of conveyance while in the territorial waters, or while otherwise within the territory of the United States. All such receptacles shall be contained inside the guard rail if on a watercraft. Such regulated garbage shall not be unloaded from such means of conveyance in the United States unless such regulated garbage is removed in tight, covered, leak-proof receptacles under the direction of an inspector to an approved facility for incineration, sterilization, or grinding into an approved sewage system, under direct supervision by such an inspector, or such regulated garbage is removed for other handling in such manner and under such supervision as may, upon request in specific cases, be approved by the Administrator as adequate to prevent the introduction and dissemination of plant pests and animal diseases and sufficient to ensure compliance with applicable laws for environmental protection. Provided that, a cruise ship may dispose of regulated garbage in landfills at Alaskan ports only, if and only if the cruise ship does not have prohibited or restricted meat or animal products on board at the time it enters Alaskan waters for the cruise season, and only if the cruise ship, except for incidental travel through international waters necessary to navigate safely between ports, remains in Canadian and U.S. waters off the west coast of North America, and calls only at continental U.S. and Canadian ports during the entire cruise season.

(A) Application for approval of a facility or sewage system may be made in writing by the authorized representative of any carrier or by the official having jurisdiction over the port or place of arrival of the means of conveyance to the Administrator, Animal and Plant Health Inspection Service, U.S. Department of Agriculture, Washington, DC 20250. The application must be endorsed by the operator of the facility or sewage system.

(B) Approval will be granted if the Administrator determines that the requirements set forth in this section are met. Approval may be denied or withdrawn at any time, if the Administrator determines that such requirements are not met, after notice of the proposed denial or withdrawal of the approval and the reasons therefor, and an opportunity to demonstrate or achieve compliance with such requirements, has been afforded to the operator of the facility or sewage system and to the applicant for approval. However, approval may also be withdrawn without such prior procedure in any case in which the public health, interest, or safety requires immediate action, and in such case, the operator of the facility or sewage system and the applicant for approval shall promptly thereafter be given notice of the withdrawal and the reasons therefore and an opportunity to show cause why the approval should be reinstated.

(iv) The Plant Protection and Quarantine Programs and Veterinary Services, Animal, and Plant Health Inspection Service, will cooperate with other Federal, State, and local agencies responsible for enforcing other statutes and regulations governing disposal of the regulated garbage to the end that such disposal shall be adequate to prevent the dissemination of plant pests and livestock or poultry diseases and comply with applicable laws for environmental protection. The inspectors, in maintaining surveillance over regulated garbage movements and disposal, shall coordinate their activities with the activities of representatives of the U.S. Environmental Protection Agency and other Federal, State, and local agencies also having jurisdiction over such regulated garbage.

(d) Garbage generated in Hawaii—(1) Applicability. This section applies to garbage generated in households, commercial establishments, institutions, and businesses prior to interstate movement from Hawaii, and includes used paper, discarded cans and bottles, and food scraps. Such garbage includes, and is commonly known as, municipal solid waste.

(i) Industrial process wastes, mining wastes, sewage sludge, incinerator ash, or other wastes from Hawaii that the Administrator determines do not pose risks of introducing animal or plant pests or diseases into the continental United States are not regulated under this section.

(ii) The interstate movement from Hawaii to the continental United States of agricultural wastes and yard waste (other than incidental amounts (less than 3 percent) that may be present in municipal solid waste despite reasonable efforts to maintain source separation) is prohibited.

(iii) Garbage generated onboard any means of conveyance during interstate movement from Hawaii is regulated under paragraph (c) of this section.

(2) Restrictions on interstate movement of garbage. The interstate movement of garbage generated in Hawaii to the continental United States is regulated as provided in this section.

(i) The garbage must be processed, packaged, safeguarded, and disposed of using a methodology that the Administrator has determined is adequate to prevent the introduction and dissemination of plant pests into noninfested areas of the United States.

(ii) The garbage must be moved under a compliance agreement in accordance with paragraph (e) of this section. APHIS will only enter into a compliance agreement when the Administrator is satisfied that the Agency has first satisfied all its obligations under the National Environmental Policy Act and all applicable Federal and State statutes to fully assess the impacts associated with the movement of garbage under the compliance agreement.

(iii) All such garbage moved interstate from Hawaii to any of the continental United States must be moved in compliance with all applicable laws for environmental protection.

(e) Compliance agreement and cancellation—(1) Any person engaged in the business of handling or disposing of garbage in accordance with this section must first enter into a compliance agreement with the Animal and Plant Health Inspection Service (APHIS). Compliance agreement forms (PPQ Form 519) are available without charge from local USDA/APHIS/Plant Protection and Quarantine offices, which are listed in telephone directories.

(2) A person who enters into a compliance agreement, and employees or agents of that person, must comply with the following conditions and any supplemental conditions which are listed in the compliance agreement, as deemed by the Administrator to be necessary to prevent the introduction and dissemination into or within the United States of plant pests and livestock or poultry diseases:

(i) Comply with all applicable provisions of this section;

(ii) Allow inspectors access to all records maintained by the person regarding handling or disposal of garbage, and to all areas where handling or disposal of garbage occurs;

(iii)(A) If the garbage is regulated under paragraph (c) of this section, remove garbage from a means of conveyance only in tight, covered, leak-proof receptacles;

(B) If the garbage is regulated under paragraph (d) of this section, transport garbage interstate in sealed, leak-proof packaging approved by the Administrator;

(iv) Move the garbage only to a facility approved by the Administrator; and

(v) At the approved facility, dispose of the garbage in a manner approved by the Administrator and described in the compliance agreement.

(3) Approval for a compliance agreement may be denied at any time if the Administrator determines that the applicant has not met or is unable to meet the requirements set forth in this section. Prior to denying any application for a compliance agreement, APHIS will provide notice to the applicant thereof, and will provide the applicant with an opportunity to demonstrate or achieve compliance with requirements.

(4) Any compliance agreement may be canceled, either orally or in writing, by an inspector whenever the inspector finds that the person who has entered into the compliance agreement has failed to comply with this section. If the cancellation is oral, the cancellation and the reasons for the cancellation will be confirmed in writing as promptly as circumstances allow. Any person whose compliance agreement has been canceled may appeal the decision, in writing, within 10 days after receiving written notification of the cancellation. The appeal must state all of the facts and reasons upon which the person relies to show that the compliance agreement was wrongfully canceled. As promptly as circumstances allow, the Administrator will grant or deny the appeal, in writing, stating the reasons for the decision. A hearing will be held to resolve any conflict as to any material fact. Rules of practice concerning a hearing will be adopted by the Administrator. This administrative remedy must be exhausted before a person can file suit in court challenging the cancellation of a compliance agreement.

(5) Where a compliance agreement is denied or canceled, the person who entered into or applied for the compliance agreement may be prohibited, at the discretion of the Administrator, from handling or disposing of regulated garbage.

(a) Disease status of regions for Newcastle disease and highly pathogenic avian influenza (HPAI)—(1) Regions in which Newcastle disease is not considered to exist. (i) A list of free regions is maintained on the APHIS website at https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/animal-and-animal-product-import-information/animal-health-status-of-regions. Copies of the list are also available via postal mail upon request to Regionalization Evaluation Services, Strategy and Policy, Veterinary Services, Animal and Plant Health Inspection Service, 4700 River Road, Unit 38, Riverdale, Maryland 20737; [email protected].

(ii) APHIS will remove a region from the list referenced in paragraph (a)(1)(i) of this section upon determining that Newcastle disease exists there based on reports APHIS receives of outbreaks of the disease in commercial birds or poultry from veterinary officials of the exporting country, from the World Organization for Animal Health (OIE), or from other sources the Administrator determines to be reliable. APHIS will add a region to this list after it conducts an evaluation of the region and finds that Newcastle disease is not likely to be present in its commercial bird or poultry populations. In the case of a region formerly on this list that is removed due to an outbreak, the region may be returned to the list in accordance with the procedures for reestablishment of a region's disease-free status in § 92.4 of this subchapter.

(2) Regions in which HPAI is considered to exist. (i) A list of affected regions is maintained on the APHIS website at https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/animal-and-animal-product-import-information/animal-health-status-of-regions. Copies of the list can be obtained via postal mail upon request to Regionalization Evaluation Services, Strategy and Policy, Veterinary Services, Animal and Plant Health Inspection Service, 4700 River Road, Unit 38, Riverdale, Maryland 20737; [email protected].

(ii) APHIS will consider a region to have HPAI and add it to this list referenced in paragraph (a)(2)(i) of this section upon determining that HPAI exists in commercial birds or poultry in the region based on reports APHIS receives of outbreaks of the disease from veterinary officials of the exporting country, from the OIE, or from other sources the Administrator determines to be reliable. APHIS will remove a region from this list only after it conducts an evaluation of the region and finds that HPAI is not likely to be present in its commercial bird or poultry populations.

(b) Carcasses, and parts or products of carcasses, including meat, from regions where Newcastle disease or HPAI is considered to exist. This paragraph applies to carcasses, and parts or products of carcasses, 4 including meat, of poultry, game birds, or other birds that were raised or slaughtered in any region where Newcastle disease or any subtype of HPAI is considered to exist (see paragraph (a) of this section); are imported from any such region; or are moved into or through any such region at any time before importation or during shipment to the United States.

(1) Carcasses of game birds, if eviscerated with heads and feet removed, may be imported from regions where Newcastle disease is considered to exist. Carcasses of game birds may not be imported from regions where any subtype of HPAI is considered to exist. Viscera, heads, and feet removed from game birds in any of these regions are ineligible for entry into the United States.

(2) Carcasses, or parts or products of carcasses, of poultry, game birds, and other birds from regions where Newcastle disease or HPAI are considered to exist may be imported for consignment to any museum, educational institution or other establishment which has provided the Administrator with evidence that it has the equipment, facilities, and capabilities to store, handle, process, or disinfect such articles so as to prevent the introduction or dissemination of Newcastle disease or HPAI into the United States, and which is approved by the Administrator. 5

(3) Carcasses, or parts or products of carcasses, including meat, of poultry, game birds, or other birds, may be imported if packed in hermetically sealed containers and if cooked by a commercial method after such packing to produce articles that are shelf stable without refrigeration.

(4) Carcasses and parts or products of carcasses, including meat, of poultry, game birds, or other birds, may be imported if they are accompanied by a certificate that is signed by a full-time, salaried veterinarian of the government agency responsible for animal health in the region and that specifies that the articles were cooked throughout to reach a minimum internal temperature of 74 °C (165 °F).

(5) Carcasses, and parts or products of carcasses, including meat, of poultry, game birds, or other birds, that originated in a region considered to be free of Newcastle disease and any subtype of HPAI, and that are processed (cut, packaged, or other processing) in a region where Newcastle disease or HPAI is considered to exist, may be imported under the following conditions:

(i) Shipment to processing establishments. All poultry, game bird, or other bird products from such regions shall be shipped from the Newcastle disease and HPAI-free region where they originated to a processing establishment 6 in the region where Newcastle disease or HPAI is considered to exist in closed containers sealed with serially numbered seals applied by an official of the national government of that region. They must be accompanied by a certificate that is signed by a full-time, salaried veterinarian of the government agency responsible for animal health in the region and that specifies the products' region of origin, the processing establishment to which the carcasses or parts or products are consigned, and the numbers of the seals applied to the shipping containers.

(A) The poultry, game bird, or other bird carcasses or parts or products may be removed from containers at the processing establishment in the region where Newcastle disease or HPAI is considered to exist only after an official of the national government has determined that the seals are intact and free of any evidence of tampering. The official must attest to this fact by signing the certificate accompanying the shipment.

(B) [Reserved]

(ii) Handling of poultry, game bird, or other bird carcasses or parts or products. Establishments in regions where Newcastle disease or HPAI is considered to exist that process poultry, game bird, or other bird carcasses or parts or products for export to the United States:

(A) May not receive or handle any live poultry or birds.

(B) Must keep any records required by this section on file at the facility for a period of at least 2 years after export of processed products to the United States, and must make those records available to USDA inspectors during inspections.

(C) May process carcasses or parts or products that originate in any region, provided that:

(1) All areas, utensils, and equipment likely to contact the carcasses or parts or products to be processed, including skinning, deboning, cutting, and packing areas, are cleaned and disinfected between processing carcasses or parts or products from regions where Newcastle disease or HPAI is considered to exist and processing those from Newcastle disease and HPAI-free regions.

(2) Carcasses or parts or products intended for export to the United States are not handled, cut, or otherwise processed at the same time as any carcasses or parts or products not eligible for export to the United States.

(3) Carcasses or parts or products intended for export to the United States are packed in clean new packaging that is clearly distinguishable from that containing any carcasses or parts or products not eligible for export to the United States.

(4) Carcasses or parts or products are stored in a manner that ensures that no cross-contamination occurs.

(iii) Cooperative service agreement. Operators of processing establishments must enter into a cooperative service agreement with APHIS to pay all expenses incurred by APHIS in inspecting the establishment. APHIS anticipates that such inspections will occur once a year. The cooperative service account must always contain a balance that is at least equal to the cost of one inspection. APHIS will charge the cooperative service account for travel, salary, and subsistence of APHIS employees, as well as administrative overhead and other incidental expenses (including excess baggage charges up to 150 pounds).

(iv) Shipment to the United States. Poultry, game bird, or other bird carcasses or parts or products to be imported into the United States must be shipped from the region where they were processed in closed containers sealed with serially numbered seals applied by an official of the national government of that region. The shipments must be accompanied by a certificate signed by an official of the national government of the region where articles were processed that lists the numbers of the seals applied and states that all of the conditions of this section have been met. A copy of this certificate must be kept on file at the processing establishment for at least 2 years.

(6) Poultry, game bird, or other bird carcasses or parts or products that do not otherwise qualify for importation under paragraphs (b)(1) through (5) of this section may be imported only if the importer applies to, and is granted a permit by, the Administrator, authorizing such importation. A permit will be given only when the Administrator determines that such importation will not constitute a risk of introduction or dissemination of Newcastle disease or HPAI into the United States. Application for a permit may be made in accordance with paragraph (d) of this section.

(c) Eggs (other than hatching eggs) from regions where Newcastle disease or HPAI is considered to exist. Eggs (other than hatching eggs 7 ) from poultry, game birds, or other birds may be imported only in accordance with this section if they: Are laid by poultry, game birds, or other birds that are raised in any region where Newcastle disease or HPAI is considered to exist (see paragraph (a) of this section); are imported from any region where Newcastle disease or HPAI is considered to exist; or are moved into or through any region where Newcastle disease or HPAI is considered to exist at any time before importation or during shipment to the United States.

(1) With a certificate. The eggs may be imported if they are accompanied by a certificate signed by a salaried veterinary officer of the national government of the region of origin or, if exported from Mexico, accompanied either by such a certificate or by a certificate issued by a veterinarian accredited by the national government of Mexico and endorsed by a full-time salaried veterinary officer of the national government of Mexico, thereby representing that the veterinarian issuing the certificate was authorized to do so, and:

(i) The eggs are imported in cases marked with the identity of the flock of origin and sealed with the seal of the national government of the region of origin.

(ii) The certificate accompanying the eggs is presented to an authorized inspector when the eggs reach the port of arrival in the United States.

(iii) The certificate identifies the flock of origin and shows the region of origin, the port of embarkation, the port of arrival, the name and address of the exporter and importer, the total number of eggs, and cases of eggs, shipped with the certificate, and the date the certificate was signed.

(iv) The certificate states that the eggs qualify for importation in accordance with this section.

(v) The certificate states that no more than 90 days before the certificate was signed, a salaried veterinary officer of the national government of the region of origin or, if exported from Mexico, by a veterinarian accredited by the national government of Mexico, inspected the flock of origin and found no evidence of communicable diseases of poultry.

(vi) The eggs were washed, to remove foreign material from the surface of the shells, and sanitized on the premises of origin with a hypochlorite solution of from 100 ppm to 200 ppm available chlorine.

(vii) The eggs were packed on the premises of origin in previously unused cases.

(viii) Before leaving the premises of origin, the cases in which the eggs were packed were sealed with a seal of the national government of the region of origin by the salaried veterinarian of the national government of the region of origin who signed the certificate or, if exported from Mexico, by the veterinarian accredited by the national government of Mexico who signed the certificate.

(ix) In addition, if the eggs were laid in any region where Newcastle disease or HPAI is considered to exist (see paragraph (a) of this section), the certificate must also state:

(A) No Newcastle disease or HPAI occurred on the premises of origin or on adjoining premises during the 90 days before the certificate was signed.

(B) There is no evidence that the flock of origin was exposed to Newcastle disease or HPAI during the 90 days before the certificate was signed.

(C) The eggs are from a region free of HPAI, or from a flock of origin found free of Newcastle disease as follows: On the seventh and fourteenth days of the 21-day period before the certificate is signed, at least 1 cull bird (a sick or dead bird, not a healthy bird that was killed) for each 10,000 live birds occupying each poultry house certified for exporting table eggs was tested for Newcastle disease virus using embryonated egg inoculation technique. The weekly cull rate of birds of every exporting poultry house within the exporting farm does not exceed 0.1 percent. The tests present no clinical or immunological evidence of Newcastle disease by embryonated egg inoculation technique from tissues of birds that were culled and have been collected by a salaried veterinary officer of the national government of the region of origin or by a veterinarian accredited by the national government of Mexico. All examinations and embryonated egg inoculation tests were conducted in a laboratory located in the region of origin, and the laboratory was approved to conduct the examinations and tests by the veterinary services organization of the national government of that region. All results were negative for Newcastle disease.

(D) Egg drop syndrome is notifiable in the region of origin and there have been no reports of egg drop syndrome in the flocks of origin of the eggs, or within a 50 kilometer radius of the flock of origin, for the 90 days prior to the issuance of the certificate.

(2) To an approved establishment for breaking and pasteurization. The eggs may be imported if they are moved from the port of arrival in the United States, under seal of the United States Department of Agriculture, to an approved establishment for breaking and pasteurization. Establishments will be approved when the Administrator determines that pasteurization and sanitation procedures for handling the eggs, and for disposing of egg shells, cases, and packing materials, are adequate to prevent the introduction of Newcastle disease and HPAI into the United States.

(3) For scientific, educational, or research purposes. The eggs may be imported if they are imported for scientific, educational, or research purposes and the Administrator has determined that the importation can be made under conditions that will prevent the introduction of Newcastle disease and HPAI into the United States. The eggs must be accompanied by a permit obtained from APHIS prior to the importation in accordance with paragraph (d) of this section, and they must be moved and handled as specified on the permit to prevent the introduction of Newcastle disease and HPAI into the United States.

(4) Other. The eggs may be imported when the Administrator determines that the eggs have been cooked or processed or will be handled in a manner that will prevent the introduction of Newcastle disease and HPAI into the United States. The eggs must be accompanied by a permit obtained from APHIS prior to the importation in accordance with paragraph (d) of this section, and they must be moved and handled as specified on the permit to prevent the introduction of Newcastle disease and HPAI into the United States.

(d) To apply for a permit, contact Strategy and Policy, Veterinary Services, Animal and Plant Health Inspection Service, 4700 River Road, Riverdale, Maryland 20737, or visit https://efile.aphis.usda.gov/s/vs-permitting-assistant.

(a) Ruminants and swine, and fresh (chilled or frozen) meats, prohibited importation under §§ 94.1, 94.8, 94.9, 94.10, 94.12, 94.14, or 94.18, which come into the United States by ocean vessel and are offered for entry and refused admission into this country, shall be destroyed or otherwise disposed of as the Administrator may direct, unless they are exported by the consignee within 48 hours, and meanwhile are retained under such isolation and other safeguards as the Administrator may require to prevent the introduction or dissemination of livestock diseases into the United States.

(b) Ruminants and swine, and fresh (chilled or frozen) meats, prohibited importation under §§ 94.1, 94.8, 94.9, 94.10, 94.12, 94.14, or 94.18, which come into the United States aboard an airplane or railroad car and are offered for entry and refused admission into this country, shall be destroyed or otherwise disposed of as the Administrator may direct, unless they are exported by the consignee within 24 hours, and meanwhile are retained under such isolation and other safeguards as the Administrator may require to prevent the introduction or dissemination of livestock diseases into the United States.

(c) Ruminants and swine, and fresh (chilled or frozen) meats, prohibited importation under §§ 94.1, 94.8, 94.9, 94.10, 94.12, 94.14, or 94.18, which come into the United States by any means other than ocean vessel, airplane, or railroad car and are offered for entry and refused admission into this country, shall be destroyed or otherwise disposed of as the Administrator may direct, unless they are exported by the consignee within 8 hours, and meanwhile are retained under such isolation and other safeguards as the Administrator may require to prevent the introduction or dissemination of livestock diseases into the United States.

(d) Ruminants and swine, and fresh (chilled or frozen) meats, prohibited importation under §§ 94.1, 94.8, 94.9, 94.10, 94.12, 94.14, or 94.18, which come into the United States by any means but are not offered for entry into this country, and other animals, meats, and other articles prohibited importation under other sections of this part, which come into the United States by any means, whether they are offered for entry into this country or not, shall be immediately destroyed or otherwise disposed of as the Administrator may direct at any time.

(a) African swine fever exists or the Administrator has reason to believe that African swine fever exists in the regions listed under paragraph (a)(2) of this section.

(1) The Administrator bases the reason to believe African swine fever exists in a region on the following factors:

(i) When a region allows the importation of host animals, pork or pork products, or vectors of African swine fever from a region in which African swine fever exists under conditions which the Administrator has determined are less stringent than those prescribed by this chapter for importing host animals, pork or pork products, or vectors of African swine fever into the United States from a region in which African swine fever exists; or

(ii) When a region allows the importation or use of African swine fever virus or cultures under conditions which the Administrator has determined are less stringent than those prescribed by this chapter for the importation or use of African swine fever virus or cultures into or within the United States; or

(iii) When a region has a contiguous border with, or is subject to commercial exchange or natural spread of African swine fever host animals, host materials, or vectors with, another region with known outbreaks of African swine fever; or

(iv) A region's lack of a disease detection, control, or reporting system capable of detecting or controlling African swine fever and reporting it to the United States in time to allow the United States to take appropriate action to prevent the introduction of African swine fever into the United States; or

(v) Any other fact or circumstance found to exist which constitutes a risk of introduction of African swine fever into the United States.

(2) A list of regions where African swine fever exists or the Administrator has reason to believe that African swine fever exists is maintained on the APHIS website at https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/animal-and-animal-product-import-information/animal-health-status-of-regions. Copies of the list are also available via postal mail upon request to Regionalization Evaluation Services, Strategy and Policy, Veterinary Services, Animal and Plant Health Inspection Service, 4700 River Road, Unit 38, Riverdale, Maryland 20737; [email protected].

(3) APHIS will add a region to the list upon determining that the disease exists in the region based on reports APHIS receives of outbreaks of the disease from veterinary officials of the exporting country, from the World Organization for Animal Health (OIE), or from other sources the Administrator determines to be reliable, or upon determining that there is reason to believe the disease exists in the region. APHIS will remove a region from the list after conducting an evaluation of the region in accordance with § 92.2 of this subchapter and finding that the disease is not present and that there is no reason to believe the disease is present. In the case of a region formerly not on this list that is added due to an outbreak, the region may be removed from the list in accordance with the procedures for reestablishment of a region's disease-free status in § 92.4 of this subchapter.

(b) No pork or pork products may be imported into the United States from any region listed in this section unless:

(1) Such pork or pork product has been fully cooked by a commercial method in a container hermetically sealed promptly after filling but before such cooking, so that such cooking and sealing produced a fully-sterilized product which is shelf-stable without refrigeration; or

(2) Such pork or pork product is not otherwise prohibited importation under this part and is consigned directly from the port of arrival in the United States to a meat processing establishment operating under Federal meat inspection, approved by the Administrator, for further processing of such pork or pork product by heat.

(3) Such pork or pork product:

(i) Was processed in a single establishment that meets the requirements in paragraph (b)(5) of this section.

(ii) Was heated by other than a flash-heating method to an internal temperature of at least 69 °C. (156 °F.) throughout after the bones had been removed.

(iii) Is accompanied to the United States by an original certificate stating that all of the requirements of this section have been met. The certificate must be written in English. The certificate must be issued by an official of the national government of the region in which the processing establishment is located. The official must be authorized to issue the foreign meat inspection certificate required by part 327 of chapter III of this title. Upon arrival of the pork or pork products in the United States, the certificate must be presented to an authorized inspector at the port of arrival.

(4) The pork product is pork rind pellets (pork skins) that were cooked in one of the following ways in an establishment that meets the requirements in paragraph (b)(5) of this section:

(i) One-step process. The pork skins must be cooked in oil for at least 80 minutes when oil temperature is consistently maintained at a minimum of 114 °C.

(ii) Two-step process. The pork skins must be dry-cooked at a minimum of 260 °C for approximately 210 minutes after which they must be cooked in hot oil (deep-fried) at a minimum of 104 °C for an additional 150 minutes.

(5) The processing establishment 8 in a region listed in this section must comply with the following requirements:

(i) All areas, utensils, and equipment likely to contact the pork or pork products to be processed, including skinning, deboning, cutting, and packing areas, and related utensils and equipment, must be cleaned and disinfected after processing pork or pork products not eligible for export to the United States and before processing any pork or pork products eligible for export to the United States.

(ii) Pork or pork products eligible for export to the United States may not be handled, cut, or otherwise processed at the same time as any pork or pork products not eligible for export to the United States.

(iii) Pork or pork products eligible for export to the United States must be packed in clean new packaging that is clearly distinguishable from that containing any pork or pork products not eligible for export to the United States.

(c) Pork or pork products consigned from the port of arrival to an approved establishment under the provisions of paragraph (b)(2) of this section shall be moved from the port of arrival to the approved establishment under Customs seals or seals of the Administrator, and shall be otherwise handled as the Administrator, may direct in order to guard against the introduction and dissemination of the contagion of African swine fever. Seals applied under this section shall not be broken except by persons authorized to do so by the Administrator.

(d) Pork or pork products imported into the United States from a region listed in this section which do not meet the requirements specified in this section shall be seized, quarantined, and disposed of as the Administrator, may direct in order to guard against the introduction and dissemination of the contagion of the disease.

(a) APHIS considers classical swine fever to exist in all regions of the world except those declared free of the disease by APHIS.

(1) A list of regions that APHIS has declared free of classical swine fever is maintained on the APHIS website at https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/animal-and-animal-product-import-information/animal-health-status-of-regions. Copies of the list are also available via postal mail upon request to Regionalization Evaluation Services, Strategy and Policy, Veterinary Services, Animal and Plant Health Inspection Service, 4700 River Road, Unit 38, Riverdale, Maryland 20737; [email protected].

(2) APHIS will add a region to the list of those it has declared free of classical swine fever after it conducts an evaluation of the region in accordance with § 92.2 of this subchapter and finds that the disease is not present. In the case of a region formerly on this list that is removed due to an outbreak, the region may be returned to the list in accordance with the procedures for reestablishment of a region's disease-free status in § 92.4 of this subchapter. APHIS will remove a region from the list of those it has declared free of classical swine fever upon determining that the disease exists in the region based on reports APHIS receives of outbreaks of the disease from veterinary officials of the exporting country, from the World Organization for Animal Health (OIE), or from other sources the Administrator determines to be reliable.

(b) The APHIS-defined European CSF region is a single region of low-risk for CSF.

(c) Except as provided in § 94.31 for the APHIS-defined European CSF region, no fresh pork or pork product may be imported into the United States from any region where classical swine fever is known to exist unless it complies with the following requirements: 9

(1) Such pork or pork product has been treated in accordance with one of the following procedures:

(i) Such pork and pork product has been fully cooked by a commercial method in a container hermetically sealed promptly after filling but before such cooking, so that such cooking and sealing produced a fully sterilized product which is shelf-stable without refrigeration;

(ii) Such pork or pork product is in compliance with the following requirements:

(A) All bones were completely removed prior to cooking; and

(B) Such pork or pork product was heated by other than a flash-heating method to an internal temperature of 69 °C. (156 °F.) throughout;

(iii) Such pork or pork product is in compliance with the following requirements:

(A) All bones have been completely removed in the region of origin, and

(B) The meat has been held in an unfrozen, fresh condition for at least 3 days immediately following the slaughter of the animals from which it was derived, and

(C) The meat has been thoroughly cured and fully dried for a period of not less than 90 days so that the product is shelf stable without refrigeration: Provided, That the period of curing and drying shall be 45 days if the pork or pork product is accompanied to the processing establishment by a certificate of an official of the national government of a classical swine fever free region which specifies that:

(1) The pork involved originated in that region and the pork or pork product was consigned to a processing establishment in ____________ (a region not listed under paragraph (a) of this section as free of classical swine fever), in a closed container sealed by the national veterinary authorities of the classical swine fever free region by seals of a serially numbered type; and

(2) The numbers of the seals used were entered on the meat inspection certificate of the classical swine fever free region which accompanied the shipment from such free region: And, provided further, That the certificate required by paragraph (c)(3) of this section also states that: The container seals specified in paragraph (c)(1)(iii)(C)(1) of this section were found intact and free of any evidence of tampering on arrival at the processing establishment by a national veterinary inspector; and the processing establishment from which the pork or pork product is shipped to the United States does not receive or process any live swine, and uses only pork or pork product which originates in regions listed under paragraph (a) of this section as free of classical swine fever and processes all such pork or pork products in accordance with paragraph (c)(1)(i), (ii), or (iii) of this section; or

(iv) Pork rind pellets (pork skins) originating in regions where classical swine fever is known to exist may be imported into the United States provided they have been cooked in one of the following ways:

(A) One-step process. The pork skins must be cooked in oil for at least 80 minutes when oil temperature is consistently maintained at a minimum of 114 °C.

(B) Two-step process. The pork skins must be dry-cooked at a minimum of 260 °C for approximately 210 minutes after which they must be cooked in hot oil (deep-fried) at a minimum of 104 °C for an additional 150 minutes.

(2) Articles under paragraph (c)(1)(ii), (iii), or (iv) of this section were prepared in an inspected establishment that is eligible to have its products imported into the United States under the Federal Meat Inspection Act and § 327.2 of this title; and,

(3) In addition to the foreign meat inspection certificate required by § 327.4 of this title, pork and pork products prepared under paragraph (c)(1)(ii), (iii), or (iv) of this section shall be accompanied by a certificate that states that the provisions of paragraph (c)(1)(ii), (iii), or (iv) of this section have been met. This certificate shall be issued by an official of the national government of the region of origin who is authorized to issue the foreign meat inspection certificate required by § 327.4 of this title. 10 Upon arrival of the pork or pork products in the United States, the certificate must be presented to an authorized inspector at the port of arrival.

(4) Small amounts of pork or pork product, subject to the restrictions in this section, may in specific cases be imported for purposes of examination, testing, or analysis if the importer applies for and receives written approval for such importation from the Administrator. Approval will be granted only when the Administrator determines that the articles have been processed by heat in a manner so that such importation will not endanger the livestock of the United States.

(d) Thoroughly cured and fully dried pork and pork products from regions where both classical swine fever and swine vesicular disease are known or considered to exist need not comply with paragraph (c)(1)(iii) of this section if they are in compliance with the provisions of § 94.12(b)(1)(iii) of this part.

(e) Uncooked pork or pork products that originated in a region considered to be free of classical swine fever (CSF) and are processed in a region where CSF exists may be imported into the United States under the following conditions:

(1) Shipment to approved establishments. (i) The uncooked pork or pork products must be shipped from the CSF-free region of origin in closed containers sealed with serially numbered seals applied by an official of the national government of that region. They must be accompanied by a certificate that is signed by an official of that region's national government and that specifies the product's region of origin, the name and number of the establishment of origin, and the processing establishment to which the uncooked pork or pork products are consigned, and the numbers of the seals applied to the shipping containers.

(ii) The uncooked pork or pork products may be removed from containers at the processing establishment in the region where CSF is considered to exist only after an official of that region's national government has determined that the seals are intact and free of any evidence of tampering.

(2) Handling of uncooked pork and pork products. Establishments 11 in regions where CSF is considered to exist that process uncooked pork or pork products for export to the United States:

(i) May not receive or handle any live swine;

(ii) May not receive, handle, or process uncooked pork or pork products that originate in regions affected with CSF;

(iii) Must keep the certificate required by paragraph (e)(1)(i) of this section on file at the facility for a period of at least 2 years after export of processed products to the United States, and must make those records available to USDA inspectors during inspections; and

(iv) Must be evaluated and approved by APHIS through a site inspection.

(3) Compliance agreement. The operators of the processing establishment must sign a compliance agreement with APHIS, stating that:

(i) All meat processed for importation to the United States will be processed in accordance with the requirements of this part; and

(ii) A full-time, salaried meat inspection official of the national government of the region in which the processing facility is located will supervise the processing and examination of the product, and certify that it has been processed in accordance with this section; and

(iii) APHIS personnel or other persons authorized by the Administrator may enter the establishment, unannounced, to inspect the establishment and its records.

(4) Cooperative service agreement. The processing establishment, or a party on its behalf, must enter into a cooperative service agreement with APHIS to pay all expenses incurred by APHIS for the initial evaluation of the processing establishment and periodically thereafter, including travel, salary, subsistence, administrative overhead, and other incidental expenses, including excess baggage up to 150 pounds. In accordance with the terms of the cooperative service agreement, before the APHIS representative's site inspection, the operator of the processing establishment or the party acting on their behalf must deposit with the Administrator an amount equal to the approximate cost of one inspection by an APHIS representative, including travel, salary, subsistence, administrative overhead, and other incidental expenses, including excess baggage up to 150 pounds. As funds from that amount are obligated, a bill for costs incurred based on official accounting records will be issued to restore the deposit to the original level, revised as necessary to allow for inflation or other changes in estimated costs. To be current, bills must be paid within 14 days of receipt.

(5) Shipment to the United States. Uncooked pork or pork products to be imported into the United States must be shipped from the region where they were processed in closed containers sealed with serially numbered seals applied by an official of the national government of that region. The shipments must be accompanied by a certificate signed by an official of the national government of the region where the pork or pork products were processed that lists the numbers of the seals applied and states that all of the conditions of this paragraph (e) have been met. The certificate shall also state that the container seals specified in paragraph (e)(1)(i) and (ii) of this section were found by an official of the region's national government to be intact and free of any evidence of tampering on arrival at the processing establishment in the CSF-affected region. A copy of this certificate must be kept on file at the processing establishment for at least 2 years.

(a) APHIS considers classical swine fever to exist in all regions of the world except those declared free of the disease by APHIS.

(1) A list of regions that APHIS has declared free of classical swine fever is maintained on the APHIS website at https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/animal-and-animal-product-import-information/animal-health-status-of-regions. Copies of the list are also available via postal mail upon request to Regionalization Evaluation Services, Strategy and Policy, Veterinary Services, Animal and Plant Health Inspection Service, 4700 River Road, Unit 38, Riverdale, Maryland 20737; [email protected].

(2) APHIS will add a region to the list of those it has declared free of classical swine fever after it conducts an evaluation of the region in accordance with § 92.2 of this subchapter and finds that the disease is not present. In the case of a region formerly on this list that is removed due to an outbreak, the region may be returned to the list in accordance with the procedures for reestablishment of a region's disease-free status in § 92.4 of this subchapter. APHIS will remove a region from the list of those it has declared free of classical swine fever upon determining that the disease exists in the region based on reports APHIS receives of outbreaks of the disease from veterinary officials of the exporting country, from the World Organization for Animal Health (OIE), or from other sources the Administrator determines to be reliable.

(b) The APHIS-defined European CSF region is a single region of low-risk for CSF.

(c) Except as provided in § 94.31 for the APHIS-defined European CSF region, no swine that are moved from or transit any region where classical swine fever is known to exist may be imported into the United States, except for wild swine imported into the United States in accordance with paragraph (d) of this section.

(d) Wild swine may be allowed importation into the United States by the Administrator upon request in specific cases under § 93.501 or § 93.504(c) of this chapter.

(a) The meat of ruminants or swine, and other animal products, and ship stores, airplane meals, and baggage containing such meat or animal products originating in any region listed as provided in paragraph (a)(2) of this section may not be imported into the United States unless the requirements in this section, in addition to other applicable requirements of chapter III of this title, are met. However, meat and meat products that meet the requirements of § 94.4 do not have to comply with the requirements of this section. As used in this section, the term “other animal product” means all parts of the carcass of any ruminant or swine, other than meat and articles regulated under part 95 or part 96 of this chapter.

(1) The regions listed under paragraph (a)(2) of this section have been declared free of foot-and-mouth disease by APHIS as provided in § 94.1(a) but supplement their national meat supply by the importation of fresh (chilled or frozen) meat of ruminants or swine from regions that APHIS considers to be affected with foot-and-mouth disease as provided in § 94.1(a); or have a common land border with regions considered to be affected with foot-and-mouth disease; or import ruminants or swine from regions considered to be affected with foot-and-mouth disease under conditions less restrictive than would be acceptable for importation into the United States. Thus, the meat may be commingled with the fresh (chilled or frozen) meat of animals from an affected region, resulting in an undue risk of introducing foot-and-mouth disease into the United States.

(2) A list of regions whose products are regulated under this section is maintained on the APHIS website at https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/animal-and-animal-product-import-information/animal-health-status-of-regions. Copies of the list are also available via postal mail upon request to Regionalization Evaluation Services, Strategy and Policy, Veterinary Services, Animal and Plant Health Inspection Service, 4700 River Road, Unit 38, Riverdale, Maryland 20737; [email protected].

(3) APHIS will add a region to the list of those whose products are regulated under this section after conducting an evaluation of the region and determining that one or more of the circumstances described in paragraph (a)(1) of this section exists. APHIS will remove a region from the list upon conducting an evaluation of the region and determining that the circumstances in paragraph (a)(1) of this section no longer exist or upon determining that foot-and-mouth disease exists in the region.

(b) All meat or other animal product from such regions, whether in personal-use amounts or commercial lots (except that which has been fully cooked by a commercial method in a container hermetically sealed promptly after filling but before such cooking and sealing produced a fully sterilized product which is shelf-stable without refrigeration) shall have been prepared only in an inspected establishment that is eligible to have its products imported into the United States under the Federal Meat Inspection Act (21 U.S.C. 601 et seq.) and the regulations in § 327.2, chapter III of this title, issued thereunder, and shall be accompanied by a Department-approved meat inspection certificate prescribed in § 327.4 in chapter III of this title, or similar certificate approved by the Administrator, as adequate to effectuate the purposes of this section, regardless of the purpose or amount of product in the shipment.

(c) Additional certification. Meat of ruminants or swine or other animal products from any region listed under paragraph (a)(2) of this section must be accompanied by additional certification by a full-time salaried veterinary official of the agency in the national government that is responsible for the health of the animals within that region. Upon arrival of the meat of ruminants or swine or other animal product in the United States, the certification must be presented to an authorized inspector at the port of arrival. The certification must give the name and official establishment number of the establishment where the animals were slaughtered, and shall state that:

(1) The slaughtering establishment is not permitted to receive animals that originated in, or have ever been in, or that have been aboard a means of conveyance at the time such means of conveyance called at or landed at a port in, a region designated under § 94.1(a) as a region where foot-and-mouth disease exists;

(2) The slaughtering establishment is not permitted to receive meat or other animal products derived from ruminants or swine which originated in such a foot-and-mouth disease affected region, or meat or other animal products from a foot-and-mouth disease free region transported through a foot-and-mouth disease affected region except in containers sealed with serially numbered seals of the National Government of the noninfected region of origin;

(3) The meat or other animal product covered by the certificate was derived from animals born and raised in a region listed under § 94.1(a) as free of foot-and-mouth disease and the meat or other animal product has never been in any region in which foot-and-mouth disease existed;

(4) The meat or other animal product has been processed, stored, and transported to the means of conveyance that will bring the article to the United States in a manner to preclude its being commingled or otherwise in contact with meat or other animal products that do not comply with the conditions contained in this certificate.

(a) APHIS considers swine vesicular disease to exist in all regions of the world except those declared free of the disease by APHIS.

(1) A list of regions that APHIS has declared free of swine vesicular disease is maintained on the APHIS website at https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/animal-and-animal-product-import-information/animal-health-status-of-regions. Copies of the list are also available via postal mail upon request to Regionalization Evaluation Services, Strategy and Policy, Veterinary Services, Animal and Plant Health Inspection Service, 4700 River Road, Unit 38, Riverdale, Maryland 20737; [email protected].

(2) APHIS will add a region to the list of those it has declared free of swine vesicular disease after it conducts an evaluation of the region in accordance with § 92.2 of this subchapter and finds that the disease is not present. In the case of a region formerly on this list that is removed due to an outbreak, the region may be returned to the list in accordance with the procedures for reestablishment of a region's disease-free status in § 92.4 of this subchapter. APHIS will remove a region from the list of those it has declared free of swine vesicular disease upon determining that the disease exists in the region based on reports APHIS receives of outbreaks of the disease from veterinary officials of the exporting country, from the World Organization for Animal Health (OIE), or from other sources the Administrator determines to be reliable.

(b) No pork or pork product may be imported into the United States from any region where swine vesicular disease is known to exist unless it complies with the following requirements and it is not otherwise prohibited importation into the United States under this part:

(1) Such pork or pork product has been treated in accordance with one of the following procedures:

(i) Such pork or pork product has been fully cooked by a commercial method in a container hermetically sealed promptly after filling, but before such cooking, so that such cooking and sealing produced a fully sterilized product which is shelf-stable without refrigeration.

(ii) Such pork or pork product is in compliance with the following requirements:

(A) All bones were completely removed prior to cooking; and

(B) Such pork or pork product received heat treatment in a commercially accepted manner used for perishable canned pork products so that it reached an internal temperature of 69 °C. (156 °F.) throughout.

(iii) Such pork or pork product if cured and dried is in compliance with the following requirements:

(A) All bones have been completely removed in the region of origin, and

(B) Such pork or pork products shall be consigned directly from the port of entry in the United States to a meat processing establishment operating under Federal meat inspection and approved by the Administrator, 12 for heating to an internal temperature of 166 °F. During movement from the port of entry to the meat processing establishment, the pork or pork products must be moved under Department seals or seals of the U.S. Customs Service, and shall be otherwise handled as the Administrator may direct in order to guard against the introduction and dissemination of swine vesicular disease. Seals applied under this section may not be broken except by persons authorized by the Administrator to do so.

(iv) Such pork or pork product, if it originated in a swine vesicular disease free region, has been cured and dried and is in compliance with the following requirements:

(A) All bones have been completely removed, either in the region of origin or in the region where the pork or pork products are processed; and

(B)(1) Such pork or pork product is accompanied from the swine vesicular disease free region of origin to the processing establishment in the swine vesicular disease affected region by a certificate signed by an official of the National Government of the swine vesicular disease free region of origin specifying that the pork or pork product involved originated in that region and the pork or pork product was consigned to a processing establishment in ____________ (a region not listed under paragraph (a)(1) of this section as free of swine vesicular disease), in a closed container sealed by the national veterinary authorities of the swine vesicular disease free region of origin by seals of a serially numbered type. The numbers of these seals shall be entered on this certificate; and

(2) The certificate required by paragraph (b)(3) of this section shall also state that:

(i) The container seals specified in paragraph (b)(1)(iv)(B)(1) of this section were found intact and free of any evidence of tampering on arrival at the processing establishment in the swine vesicular disease affected region by a national veterinary inspector of that region,

(ii) The processing establishment from which the pork or pork product was shipped to the United States does not receive or process any live swine, and uses only pork or pork products which originate in regions listed under paragraph (a)(1) of this section as free of swine vesicular disease; and

(iii) That such establishment processes all such pork or pork products in accordance with paragraph (b)(1)(i), (ii), (iii) or (iv) of this section.

(v) Such pork or pork product is in compliance with the following requirements:

(A) All bones were completely removed prior to cooking; and

(B) Such pork or pork product received continual heat treatment in an oven for a minimum of 10 hours so that it reached an internal temperature of 65 °C. (149 °F.) throughout. The oven temperature started at a minimum of 62 °C. (143.6 °F.) and reached at least 85 °C. (185 °F.).

(vi) Pork rind pellets (pork skins) must be cooked in one of the following ways:

(A) One-step process. The pork skins must be cooked in oil for at least 80 minutes when oil temperature is consistently maintained at a minimum of 114 °C.

(B) Two-step process. The pork skins must be dry-cooked at a minimum of 260 °C for approximately 210 minutes after which they must be cooked in hot oil (deep-fried) at a minimum of 104 °C for an additional 150 minutes.

(2) Articles under paragraph (b)(1)(ii), (iii) or (iv) of this section were prepared in an inspected establishment that is eligible to have its products imported into the United States under the Federal Meat Inspection Act and the regulations in § 327.2 in chapter III of this title.

(3) In addition to the foreign meat inspection certificate required in § 327.4 of this title, pork or pork products prepared under paragraph (b)(1)(ii), (iii) or (iv) of this section shall be accompanied by certification that paragraph (b)(1)(ii), (b)(1)(iii)(A), or (b)(1)(iv)(B)(2) of this section has been met. The certification shall be issued by an official of the national government of the region of origin who is authorized to issue the foreign meat inspection certificate required by § 327.4 of this title. 13 Upon arrival of the pork or pork products in the United States, the certificate must be presented to an authorized inspector at the port of arrival.

(4) Small amounts of pork or pork product subject to the restrictions of this section, may in specific cases be imported for purposes of examination, testing, or analysis, if the importer applies for and receives written approval for such importation from the Administrator, authorizing such importation. Approval will be granted only when the Administrator determines that the articles have been processed by heat in a manner so that such importation will not endanger the livestock of the United States.

(c) Requirements for pork-filled pasta products from regions affected with swine vesicular disease. (1) Pork-filled pasta products processed for export to the United States may only be filled with pork or pork products that are otherwise eligible to be exported to the United States and that meet the requirements of paragraph (b)(1)(i), (ii), or (v) of this section or of § 94.17.

(2) The operator of the pork-filled pasta processing facility must have signed a cooperative service agreement with APHIS prior to receipt of the pork intended to be used in pork-filled pasta products, stating that all such pork will be processed only in accordance with § 94.12 or § 94.17. Pursuant to the cooperative service agreement, the establishment must allow the unannounced entry into the establishment of APHIS representatives, or other persons authorized by the Administrator, for the purpose of inspecting the facilities, operations, and records of the establishment. The establishment must be current in paying all costs for such inspections (it is anticipated that such inspections will occur up to four times per year). These costs include travel, salary, subsistence, administrative overhead, and other incidental expenses (including an excess baggage provision up to 150 pounds). In accordance with the terms of the cooperative service agreement, the operator of the processing establishment must deposit with the Administrator an amount equal to the approximate costs for APHIS to inspect the establishment one time, including travel, salary, subsistence, administrative overhead and other incidental expenses (including an excess baggage provision up to 150 pounds), and, as funds from that amount are obligated, bills for costs incurred based on official accounting records will be issued to restore the deposit to its original level. Amounts to restore the deposit to its original level must be paid within 14 days of receipt of such bills.

(3) At the pasta processing establishment, pork intended to be used for pork-filled pasta products for export to the United States must be stored apart from any meat or meat products not eligible for export to the United States, either in a separate storage room or facility or in a separate area of the same storage room. Any storage room area reserved for pork or pork products eligible for export to the United States must be separated by at least 1 meter from any storage room area where meat or meat products ineligible for export to the United States are stored and must be marked by signs and by having its borders outlined on the floor.

(4) Prior to handling pork used for pork-filled pasta products intended for export to the United States, workers at the processing facility who handle pork or pork products in the facility must shower and put on a full set of clean clothes, or wait 24 hours after handling pork or pork products that are not eligible for importation into the United States.

(5) All equipment and machinery that will come in contact with the pork or other ingredients of pork-filled pasta products intended for export to the United States must be cleaned and disinfected before each use.

(6) Processing lines working with pork-filled pasta products for export to the United States must be totally dedicated to the production of such products for the time needed to complete a given lot. When any processing line in a facility is working with pork-filled pasta products intended for export to the United States, no other processing lines in the same facility may work on products using meat that is not eligible for export to the United States.

(7) Processing facilities that are completely dedicated to producing only pork-filled pasta products for export to the United States and do not receive, handle, or process any animal product not intended for export to the United States are exempt from the requirements of paragraphs (c)(3) through (c)(6) of this section.

(8) During processing, the pork-filled pasta must be steam-heated to a minimum internal temperature of 90 °C, then dried, cooled, and packed to make the product shelf stable without refrigeration.

(9) The processing facility must maintain under lock and key, for a minimum of 2 years, an original record of each lot of pork or pork products used for pork-filled pasta products for export to the United States. Each record must include the following:

(i) The date that the cooked or dry-cured pork product was received in the processing facility;

(ii) The number of packages, the number of hams or cooked pork products per package, and the weight of each package;

(iii) A lot number or other identification marks;

(iv) The health certificate that accompanied the cooked or dry-cured pork product from the slaughter/processing facility to the meat-filled pasta product processing facility; and

(v) The date that the pork or pork product used in the pasta started dry curing (if the product used is a dry-cured ham) or the date that the product was cooked (if the product used is a cooked pork product).

(10) The pork-filled pasta must be accompanied by a certificate issued by an official of the National Government of the region in which the pasta product is processed who is authorized to issue the foreign meat inspection certificate required under § 327.4 of this title, stating that the pork-filled pasta product has been processed in accordance with the requirements of this section.

Upon arrival of the pork-filled pasta in the United States, the certificate must be presented to an inspector at the port of arrival.

(a) Pork or pork products and ship's stores, airplane meals, and baggage containing pork or pork products, other than those articles regulated under part 95 or part 96 of this chapter, produced in any region listed under paragraph (a)(2) of this section may not be imported into the United States unless the requirements of this section, in addition to other applicable requirements of part 327 of this title, are met.

(1) The regions listed under paragraph (a)(2) of this section have been declared free of swine vesicular disease as provided in § 94.12(a) but supplement their national pork supply by the importation of fresh (chilled or frozen) meat of animals from regions where swine vesicular disease is considered to exist, or have a common border with such regions, or have trade practices that are less restrictive than are acceptable to the United States. Thus, the pork or pork products may be commingled with fresh (chilled or frozen) meat of animals from a region where swine vesicular disease is considered to exist, resulting in an undue risk of swine vesicular disease introduction into the United States.

(2) A list of regions whose products are regulated under this section is maintained on the APHIS website at https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/animal-and-animal-product-import-information/animal-health-status-of-regions. Copies of the list are also available via postal mail upon request to Regionalization Evaluation Services, Strategy and Policy, Veterinary Services, Animal and Plant Health Inspection Service, 4700 River Road, Unit 38, Riverdale, Maryland 20737; [email protected].

(3) APHIS will add a region to the list of those whose products are regulated under this section after conducting an evaluation of the region and determining that one or more of the circumstances listed in paragraph (a)(1) of this section exists. APHIS will remove a region from the list upon conducting an evaluation of the region and determining that the circumstances in paragraph (a)(1) of this section no longer exist or upon determining that swine vesicular disease exists in the region.

(b) All such pork or pork products, except those treated in accordance with § 94.12(b)(1)(i) of this part, shall have been prepared only in inspected establishments that are eligible to have their products imported into the United States under the Federal Meat Inspection Act (21 U.S.C. 601 et seq.) and under § 327.2 of this title and shall be accompanied by the foreign meat inspection certificate required by § 327.4 of this title. Upon arrival of the pork or pork products in the United States, the foreign meat inspection certificate must be presented to an authorized inspector at the port of arrival.

(c) Unless such pork or pork products are treated according to one of the procedures described in § 94.12(b) of this part, the pork or pork products must be accompanied by an additional certificate issued by a full-time salaried veterinary official of the agency in the national government responsible for the health of the animals within that region. Upon arrival of the pork or pork products in the United States, the certificate must be presented to an authorized inspector at the port of arrival. The certificate shall state the name and official establishment number of the establishment where the swine involved were slaughtered and the pork was processed. The certificate shall also state that:

(1) The slaughtering establishment is not permitted to receive animals that originated in a region considered to have swine vesicular disease or that have ever been in a region in which swine vesicular disease existed.

(2) The slaughtering establishment is not permitted to receive pork derived from swine which originated in such a region or pork from swine from a swine vesicular disease free region which has been transported through a region where swine vesicular disease is considered to exist except pork which was transported in containers sealed with serially numbered seals of the National Government of a region of origin listed under § 94.12(a) as a region considered free of the disease.

(3) The pork has been processed, stored, and transported to the means of conveyance that will bring the article to the United States in a manner that precludes its being commingled or otherwise coming in contact with pork or pork products that have not been handled in accordance with the requirements of this section.

(a) Swine vesicular disease is known to exist in all regions of the world except those listed under § 94.12(a) of this part. No swine which are moved from or transit any region in which swine vesicular disease is known to exist may be imported into the United States except wild swine imported in accordance with paragraph (b) of this section.

(b) Wild swine may be allowed importation into the United States by the Administrator upon request in specific cases under § 93.501 or § 93.504(c) of this chapter.

(a) Any meat or other animal product or material (excluding materials that are required to be consigned to USDA-approved establishments for further processing) eligible for entry into the United States, as provided in this part or in part 95 of this subchapter, may transit the United States by air and ocean ports and overland transportation if the articles are accompanied by the required documentation specified in this part and in part 95.

(b) Any meat or other animal product or material not eligible for entry into the United States, as provided in this part or in part 95 of this subchapter, may transit air and ocean ports only, with no overland movement outside the airport terminal area or dock area of the maritime port, in the United States for immediate export if the conditions of paragraphs (b)(1) through (4) of this section are met.

(1) The articles must be sealed in leakproof containers bearing serial numbers during transit. Each container must remain under either Customs seal or foreign government seal during the entire time that it is in the United States.

(2) Before transit, the person moving the articles must notify, in writing, the authorized Customs inspector at both the place in the United States where the articles will arrive and the port of export. The notification must include the:

(i) Times and dates of arrival in the United States;

(ii) Times and dates of exportation from the United States;

(iii) Mode of transportation; and

(iv) Serial numbers of the sealed containers.

(3) The articles must transit the United States under Customs bond.

(4) The shipment is exported from the United States within 7 days of its entry.

(c) Pork and pork products from Baja California, Baja California Sur, Campeche, Chihuahua, Coahuila, Nuevo Leon, Quintana Roo, Sinaloa, Sonora, and Yucatan, Mexico, that are not eligible for entry into the United States in accordance with this part may transit the United States via land border ports for immediate export if the following conditions of paragraphs (c)(1) through (4) of this section are met:

(1) The person moving the pork and pork products must obtain a United States Veterinary Permit for Importation and Transportation of Controlled Materials and Organisms and Vectors. To apply for a permit, file a permit application on VS Form 16-3 (available from APHIS, Veterinary Services, Strategy and Policy, 4700 River Road Unit 38, Riverdale, MD 20737-1231, or electronically at https://www.aphis.usda.gov/animal_health/permits/).

(2) The pork or pork products are packaged at a Tipo Inspección Federal plant in Baja California, Baja California Sur, Campeche, Chihuahua, Coahuila, Nuevo Leon, Quintana Roo, Sinaloa, Sonora, or Yucatan, Mexico, in leakproof containers and sealed with serially numbered seals of the Government of Mexico, and the containers remain sealed during the entire time they are in transit across Mexico and the United States.

(3) The person moving the pork and pork products through the United States notifies, in writing, the authorized Customs inspector at the United States port of arrival prior to such transiting. The notification must include the following information regarding the pork and pork products:

(i) Permit number;

(ii) Times and dates of arrival in the United States;

(iii) Time schedule and route to be followed through the United States; and

(iv) Serial numbers of the seals on the containers.

(4) The pork and pork products must transit the United States under Customs bond and must be exported from the United States within the time limit specified on the permit. Any pork or pork products that have not been exported within the time limit specified on the permit or that have not been transited in accordance with the permit or applicable requirements of this part will be destroyed or otherwise disposed of as the Administrator may direct pursuant to the Animal Health Protection Act (7 U.S.C. 8301 et seq.).

(d) Poultry carcasses, parts, or products (except eggs and egg products) from Baja California, Baja California Sur, Campeche, Chihuahua, Nuevo Leon, Quintana Roo, Sinaloa, Sonora, Tamaulipas, or Yucatan, Mexico, that are not eligible for entry into the United States in accordance with the regulations in this part may transit the United States via land ports for immediate export if the following conditions of paragraphs (d)(1) through (4) of this section are met:

(1) The person moving the poultry carcasses, parts, or products through the United States must obtain a United States Veterinary Permit for Importation and Transportation of Controlled Materials and Organisms and Vectors. To apply for a permit, file a permit application on VS Form 16-3 (available from APHIS, Veterinary Services, Strategy and Policy, 4700 River Road Unit 38, Riverdale, MD 20737-1231, or electronically at https://www.aphis.usda.gov/animal_health/permits/).

(2) The poultry carcasses, parts, or products are packaged at a Tipo Inspección Federal plant in Baja California, Baja California Sur, Campeche, Chihuahua, Nuevo Leon, Quintana Roo, Sinaloa, Sonora, Tamaulipas, or Yucatan, Mexico, in leakproof containers with serially numbered seals of the Government of Mexico, and the containers remain sealed during the entire time they are in transit through Mexico and the United States.

(3) The person moving the poultry carcasses, parts, or products through the United States must notify, in writing, the authorized U.S. Customs and Border Protection (CBP) inspector at the United States port of arrival prior to such transiting. The notification must include the following information regarding the poultry to transit the United States:

(i) Permit number;

(ii) Times and dates of arrival in the United States;

(iii) Time schedule and route to be followed through the United States; and

(iv) Serial numbers of the seals on the containers.

(4) The poultry carcasses, parts, or products must transit the United States under U.S. Customs bond and must be exported from the United States within the time limit specified on the permit. Any poultry carcasses, parts, or products that have not been exported within the time limit specified on the permit or that have not transited in accordance with the permit or applicable requirements of this part will be destroyed or otherwise disposed of as the Administrator may direct pursuant to the Animal Health Protection Act (7 U.S.C. 8301 et seq.).

(e) Meat and other products of ruminants or swine from regions listed in § 94.11(a) and pork and pork products from regions listed in § 94.13 that do not meet the requirements of § 94.11(b) or § 94.13(a) may transit through the United States for immediate export, provided the provisions of paragraph (b) of this section are met, and provided all other applicable provisions of this part are met.

(a) The following milk products are exempt from the provisions of this part:

(1) Cheese, but not including cheese with liquid and not including cheese containing any item that is regulated by other sections of this part, unless such item is independently eligible for importation into the United States under this part;

(2) Butter; and

(3) Butteroil.

(b) Milk and milk products originating in, or shipped from, any region where foot-and-mouth disease is considered to exist under § 94.1(a) may be imported into the United States if they meet the requirements of paragraphs (b)(1), (2), or (3) of this section:

(1) They are in a concentrated liquid form and have been processed by heat by a commercial method in a container hermetically sealed promptly after filling but before such heating, so as to be shelf stable without refrigeration.

(2) They are dry milk or dry milk products, including dry whole milk, nonfat dry milk, dried whey, dried buttermilk, and formulations which contain any such dry milk products, and are consigned directly to an approved establishment 14 for further processing in a manner approved by the Administrator, as adequate to prevent the introduction or dissemination of livestock diseases into the United States. However, in specific cases, upon request by the importer to the Administrator, and approval by the Administrator, they may be stored for a temporary period in an approved warehouse 14 under the supervision of an inspector of the Animal and Plant Health Inspection Service pending movement to an approved establishment. Such products shall be transported from the United States port of first arrival to an approved establishment 14 or an approved warehouse, 14 and from an approved warehouse 14 to an approved establishment 14 only under Department seals or seals of the U.S. Customs Service. Such seals shall be broken only by such an inspector or other person authorized to do so by the Administrator. Such products shall not be removed from the approved warehouse 14 or approved establishment 14 except upon special permission by the Administrator, and upon compliance with all the conditions and requirements specified by him for such movement in each specific case.

(3) Milk and milk products not exempted under paragraph (a) and not of classes included within the provisions of paragraphs (b)(1) or (2) of this section may be imported if the importer first applies to and receives written permission from the Administrator, authorizing such importation. Permission will be granted only when the Administrator determines that such action will not endanger the health of the livestock of the United States. Products subject to this provision include but are not limited to condensed milk, long-life milks such as sterilized milk, casein and caseinates, lactose, and lactalbumin.

(4) Small amounts of milk and milk products subject to the restrictions of this part may in specific cases be imported for purposes of examination, testing, or analysis, if the importer applies to and receives written approval for such importation from the Administrator. Approval will be granted only when the Administrator determines that such action will not endanger the health of the livestock of the United States.

(c) Milk and milk products originating in and shipped from regions listed under § 94.1(a) as free of foot-and-mouth disease but which have entered a port or otherwise transited a region where APHIS considers the disease to exist may not be imported into the United States unless:

(1) The product was transported under serially numbered official seals applied at the point of origin of the shipment by an authorized representative of the region of such origin; except that, if any seal applied at the point of origin was broken by any foreign official to inspect the shipment, an authorized representative of that region applied a new serially numbered official seal to the hold, compartment, or container in which the milk or milk products were transported; and if any member of a ship's crew broke a seal, the serial number of the seal, the location of the seal, and the reason for breaking the seal were recorded in the ship's log.

(2) The numbers of such seals are listed on, or are on a list attached to, the bill of lading or similar document accompanying the shipment.

(3) Upon arrival of the carrier at the United States port, an inspector of the Animal and Plant Health Inspection Service determines that the seals are intact and that their numbers are in agreement with the numbers appearing on the accompanying document; Provided, That, if the representative finds that any seal has been broken or has a different number than is recorded on the accompanying document, then the milk or milk products may remain eligible for entry into the United States only if APHIS personnel are available to inspect the hold, compartment, or container, the cartons or other containers of milk or milk products, and all accompanying documentation; and the importer furnishes additional documentation (either copies of pages from the ship's log signed by the officer-in-charge, or certification from a foreign government that the original seal was removed and the new seal applied by officials of the government) that demonstrates to the satisfaction of the Administrator that the milk or milk products were not contaminated or exposed to contamination during movement from the region of origin to the United States.

(d) Except for milk and milk products imported from Canada, and except as provided in this paragraph, milk or milk products imported from a region listed under § 94.1(a) as free of foot-and-mouth disease must be accompanied by a certificate endorsed by a full-time, salaried veterinarian employed by the region of export. The certificate must state that the milk was produced and processed in a region listed under § 94.1(a) as free of foot-and-mouth disease, or that the milk product was processed in one such region from milk produced in another such region. The certificate must name the region in which the milk was produced and the region in which the milk or milk product was processed. Further, the certificate must state that, except for movement under seal as described in § 94.16(c), the milk or milk product has never been in a region in which foot-and-mouth disease exists. Milk or milk products from a region listed under § 94.1(a) as free of foot-and-mouth disease and that were processed in whole or in part from milk or milk products from a region not listed under § 94.1(a) as free of foot-and-mouth disease may be imported into the United States only in accordance with paragraph (b)(3) of this section.

Notwithstanding any other provisions in this part, dry-cured ham, pork shoulder, or pork loin, whether whole or sliced and packaged, shall not be prohibited from being imported into the United States if it meets the following conditions:

(a) Except for Italian-type hams, Serrano hams, Iberian hams, Iberian pork shoulders, and Iberian pork loins that have been processed in accordance with paragraph (i) of this section, the dry-cured ham, pork shoulder, or pork loin came from a swine that was never out of the region in which the dry-cured ham, pork shoulder, or pork loin was processed;

(b) The ham, pork shoulder, or pork loin came from a region determined by the Administrator, to have and to enforce laws requiring the immediate reporting to the national veterinary services in that region any premises found to have any animal infected with foot-and-mouth disease, African Swine fever, classical swine fever, or swine vesicular disease;

(c) The ham, pork shoulder, or pork loin came from a swine that was not on any premises where foot-and-mouth disease, African swine fever, classical swine fever, or swine vesicular disease exists or had existed within 60 days prior to slaughter;

(d) The whole ham, pork shoulder, or pork loin was accompanied from the slaughtering facility to the processing establishment by a numbered certificate issued by a person authorized by the government of the region of origin stating that the provisions of paragraphs (a) and (c) of this section have been met;

(e) The ham, pork shoulder, or pork loin was processed whole as set forth in paragraph (i) of this section in only one processing establishment; 15

(f) The ham, pork shoulder, or pork loin was processed whole in a processing establishment that prior to the processing of any hams, pork shoulders, or pork loins in accordance with this section, was inspected by a veterinarian of APHIS and determined by the Administrator, to be capable of meeting the provisions of this section for processing hams, pork shoulders, or pork loins for importation into the United States;

(g) The ham, pork shoulder, or pork loin was processed whole in a processing establishment for which the operator of the establishment has signed an agreement with APHIS prior to receipt of the hams, pork shoulders, or pork loins for processing, stating that all hams, pork shoulders, or pork loins processed for importation into the United States will be processed only in accordance with the provisions of this part;

(h) Workers who handle fresh pork in the processing establishment where the dry-cured ham, pork shoulder, or pork loin was processed whole are required to shower and put on a full set of clean clothes, or to wait 24 hours after handling fresh pork, before handling hams, pork shoulders, or pork loins that have progressed in the aging/curing process as follows:

(1) In the case of Italian-type hams processed in accordance with paragraph (i)(1) of this section, those that have progressed beyond the final wash stage;

(2) In the case of Serrano hams or Iberian hams or pork shoulders processed in accordance with paragraphs (i)(2), (i)(3), or (i)(4) of this section, those that have progressed beyond salting; and

(3) In the case of Iberian pork loins processed in accordance with paragraph (i)(5) of this section, those that have progressed beyond being placed in a casing.

(i) The dry-cured ham, pork shoulder, or pork loin was processed whole in accordance with this paragraph. Except for pork fat treated to at least 76 °C (168.8 °F), which may have been placed over the meat during curing, the dry-cured pork product must have had no contact with any other meat or animal product during processing.

(1) Italian-type hams. The ham was processed for a period of not less than 400 days in accordance with the following conditions: after slaughter the ham was held at a temperature of 0-3 °C. (32-34.7 °F) for a minimum of 72 hours during which time the “aitch” bone and the foot was removed and the blood vessels at the end of the femur were massaged to remove any remaining blood; thereafter the ham was covered with an amount of salt equal to 4-6 percent of the weight of the ham, with a sufficient amount of water added to ensure that the salt had adhered to the ham; thereafter the ham was placed for 5-7 days on racks in a chamber maintained at a temperature of 0-4 °C. (32-39.2 °F) and at a relative humidity of 70-85 percent; thereafter the ham was covered with an amount of salt equal to 4-6 percent of the weight of the ham, with a sufficient amount of water added to ensure that the salt had adhered to the ham; thereafter the ham was placed for 21 days in a chamber maintained at a temperature of 0-4 °C. (32-39.2 °F.) and at a relative humidity of 70-85 percent; thereafter the salt was brushed off the ham; thereafter the ham was placed in a chamber maintained at a temperature of 1-6 °C. (33.8-42.8 °F.) and at a relative humidity of 65-80 percent for between 52 and 72 days; thereafter the ham was brushed and rinsed with water; thereafter the ham was placed in a chamber for 5-7 days at a temperature of 15-23 °C. (59-73.4 °F.) and a relative humidity of 55-85 percent; thereafter the ham was placed for curing in a chamber maintained for a minimum of 314 days at a temperature of 15-20 °C. (59-68 °F.) and at a relative humidity of 65-80 percent at the beginning and increased by 5 percent every 2 1/2 months until a relative humidity of 85 percent was reached.

(2) Serrano hams. Serrano hams were processed as follows (190-day minimum curing process):

(i) If the ham is received frozen, it was thawed in a chamber with relative humidity between 70 and 80 percent, with room temperature maintained at 12 °C to 13 °C (53.6 °F to 55.4 °F) for the first 24 hours, then at 13 °C to 14 °C (55.4 °F to 57.2 °F) until the internal temperature of the ham reached 3 °C to 4 °C (37.4 °F to 39.2 °F), at which point the blood vessels at the end of the femur were massaged to remove any remaining blood.

(ii) The ham was covered in salt and placed in a chamber maintained at a temperature from 0 °C to 4 °C (32 °F to 39.2 °F), with relative humidity between 75 and 95 percent, for a period no less than 0.65 days per kg and no more than 2 days per kg of the weight of the ham.

(iii) The ham was rinsed with water and/or brushed to remove any remaining surface salt.

(iv) The ham was placed in a chamber maintained at a temperature of 0 °C to 6 °C (32 °F to 42.8 °F), with a relative humidity of 70 to 95 percent, for no less than 40 and no more than 60 days;

(v) The ham was placed for curing in a chamber with a relative humidity of 60 to 80 percent and a temperature gradually raised in 3 phases, as follows:

(A) A temperature of 6 °C to 16 °C (42.8 °F to 60.8 °F), maintained for a minimum of 45 days;

(B) A temperature of 16 °C to 24 °C (60.8 °F to 75.2 °F), maintained for a minimum of 35 days;

(C) A temperature of 24 °C to 34 °C (75.2 °F to 93.2 °F), maintained for a minimum of 30 days;

(vi) Finally, with the relative humidity unchanged at 60 to 80 percent, the temperature was lowered to 12 °C to 20 °C (53.6 °F to 68 °F) and maintained at that level for a minimum of 35 days, until at least 190 days after the start of the curing process; Except that: In a region where swine vesicular disease exists, the ham must be maintained at that level an additional 370 days, until at least 560 days after the start of the curing process.

(3) Iberian hams. Iberian hams were processed as follows (365-day minimum curing process):

(i) If the ham is received frozen, it was thawed in a chamber with relative humidity between 70 and 80 percent, with room temperature maintained at 5.5 °C to 6.5 °C (41.9 °F to 43.7 °F) for the first 24 hours, then at 9.5 °C to 10.5 °C (49.1 °F to 50.9 °F) until the internal temperature of the ham reached 3 °C to 4 °C (37.4 °F to 39.2 °F), at which point the blood vessels at the end of the femur were massaged to remove any remaining blood.

(ii) The ham was covered in salt and placed in a chamber maintained at a temperature from 0 °C to 4 °C (32 °F to 39.2 °F), with relative humidity between 75 and 95 percent, and kept in the chamber for a period no less than 0.65 days per kg and no more than 2 days per kg of the weight of the ham;

(iii) The ham was rinsed with water and/or brushed to remove any remaining surface salt.

(iv) The ham was placed in a chamber maintained at a temperature of 0 °C to 6 °C (32 °F to 42.8 °F), with relative humidity of 70 to 95 percent, for no less than 40 and no more than 60 days.

(v) The ham was placed for curing in a chamber with a temperature of 6 °C to 16 °C (42.8 °F to 60.8 °F) and relative humidity of 60 to 80 percent for a minimum of 90 days.

(vi) The temperature was raised to 16 °C to 26 °C (60.8 °F to 78.8 °F) and the relative humidity reduced to 55 to 85 percent, for a minimum of 90 days.

(vii) Finally, with the relative humidity raised to 60 to 90 percent, the temperature was lowered to 12 °C to 22 °C (53.6 °F to 71.6 °F) and maintained at that level for a minimum of 115 days, until at least 365 days after the start of the curing process; Except that: In a region where swine vesicular disease exists, the ham must be maintained at that level an additional 195 days, until at least 560 days after the start of the curing process.

(4) Iberian pork shoulders. Iberian pork shoulders were processed as follows (240-day minimum curing process):

(i) If the pork shoulder is received frozen, it was thawed at a room temperature of 12 °C to 13 °C (53.6 °F to 55.4 °F), with the relative humidity between 75 and 85 percent, for approximately 24 hours, until the internal temperature reached 3 °C to 4 °C (37.4 °F to 39.2 °F), at which point the blood vessels in the scapular region were massaged to remove any remaining blood.

(ii) The pork shoulder was covered in salt and placed in a chamber maintained at a temperature of 0 °C to 4 °C (32 °F to 39.2 °F) with the relative humidity between 75 and 95 percent, for a period of no less than 0.65 days per kg and no more than 2 days per kg of the weight of the pork shoulder.

(iii) The pork shoulder was rinsed with water and/or brushed to remove any remaining surface salt.

(iv) The pork shoulder was placed in a chamber maintained at a temperature of 0 °C to 6 °C (32 °F to 42.8 °F) and a relative humidity of 70 to 95 percent for not less than 40 days and not more than 60 days.

(v) The pork shoulder was placed for curing in a chamber at a temperature of 6 °C to 16 °C (42.8 °F to 60.8 °F) and a relative humidity of 60 to 80 percent for a minimum of 90 days.

(vi) The temperature was raised to 16 °C to 26 °C (60.8 °F to 78.8 °F) and the relative humidity was changed to 55 to 85 percent, and those levels were maintained for a minimum of 90 days.

(vii) Finally, the temperature was reduced to 12 °C to 22 °C (53.6 °F to 71.6 °F) and the relative humidity was raised to 60 to 90 percent for a minimum of 45 days, until at least 240 days after the start of the curing process.

(5) Iberian pork loins. Iberian pork loins were processed as follows (130-day minimum curing process):

(i) If the pork loin is received frozen, it was thawed at a room temperature maintained at 11 °C to 12 °C (51.8 °F to 53.6 °F), with the relative humidity between 70 and 80 per cent for the first 24 hours, then between 75 and 85 percent, until the loin's internal temperature reached 3 °C to 4 °C (37.4 °F to 39.2 °F), at which point the external fat, aponeurosis, and tendons were cleaned from the loin.

(ii) The pork loin was covered in a pickle preparation (25-30 grams of salt for each kilogram of pork loin) and placed in a chamber where it was maintained at a relative humidity of 75 to 95 percent and a temperature of 3 °C to 4 °C (37.4 °F to 39.2 °F) for 72 hours.

(iii) The pork loin was removed from the pickle preparation (25-30 grams of salt for each kilogram of pork loin), externally cleaned (brushed or rinsed), placed in an artificial casing, and fastened shut with a metal clip.

(iv) The pork loin was placed for curing in a chamber with a relative humidity of 60 to 90 percent and a temperature gradually raised in 3 phases, as follows:

(A) A temperature of 2 °C to 6 °C (35.6 °F to 42.8 °F), maintained for a minimum of 20 days;

(B) A temperature of 6 °C to 15 °C (42.8 °F to 59.0 °F), maintained for a minimum of 20 days;

(C) A temperature of 15 °C to 25 °C (59.0 °F to 77.0 °F), maintained for a minimum of 40 days;

(v) Finally, with the relative humidity unchanged at 60 to 80 percent and the temperature lowered to 0 °C to 5 °C (32.0 °F to 41.0 °F), the pork loin was vacuum-packed and maintained under those conditions for a minimum of 15 days, until at least 130 days after the start of the curing process.

(j)(1) The whole ham, if it is Italian-type ham processed in accordance with paragraph (i)(1) of this section, bears a hot iron brand or an ink seal (with the identifying number of the slaughtering establishment) which was placed thereon at the slaughtering establishment under the direct supervision of a person authorized to supervise such activity by the veterinary services of the national government of the region of origin, bears a button seal (approved by the Administrator, as being tamper-proof) on the hock that states the month and year the ham entered the processing establishment and a hot iron brand (with the identifying number of the processing establishment and the date salting began) which were placed thereon at the processing establishment immediately prior to salting, under the supervision of a person authorized to supervise such activity by the veterinary services of the national government of the region of origin;

(2) The whole dry-cured ham, if it is processed in accordance with paragraphs (i)(2) or (i)(3) of this section, or the whole dry-cured pork shoulder, if it is processed in accordance with paragraph (i)(4) of this section, bears an ink seal (with the identifying number of the slaughtering establishment) which was placed thereon at the slaughtering establishment under the direct supervision of a person authorized to supervise such activity by the veterinary services of the national government of the region of origin, and an ink seal (with the identifying number of the processing establishment and the date the salting began) which was placed thereon at the processing establishment, immediately prior to salting, under the supervision of a person authorized to supervise such activity by the veterinary services of the national government of the region of origin; or

(3) The whole dry-cured pork loin, if it is processed in accordance with paragraph (i)(5) of this section, is packaged with material that bears a seal of the government of the region of origin which was placed thereon at the slaughtering establishment under the direct supervision of a person authorized to supervise such activity by the veterinary services of the national government of the region of origin, and bears a tamper-proof plastic tag, securely attached to the pork loin itself, that states the identifying number of the slaughtering establishment and the date the pork loin was placed in the pickle preparation under the supervision of a person authorized to supervise such activity by the veterinary service of the national government of the region of origin.

(k) The whole dry-cured ham, pork shoulder, or pork loin came from an establishment where a person authorized by the veterinary services of the national government of the region of origin to conduct activities under this paragraph, maintained original records (which shall be kept for a minimum of two years) identifying the dry-cured ham, pork shoulder, or pork loin by the date it entered the processing establishment, by the slaughtering facility from which it came, and by the number of the certificate which accompanied the dry-cured ham, pork shoulder, or pork loin from the slaughtering facility to the processing establishment, and where such original records are maintained under lock and key by such person, with access to such original records restricted to officials of the government of the region of origin, officials of the United States Government, and such person maintaining the records;

(l) The whole dry-cured ham, pork shoulder, or pork loin came from a processing establishment which allows the unannounced entry into the establishment of APHIS personnel, or other persons authorized by the Administrator, for the purpose of inspecting the establishment and records of the establishment;

(m) The dry-cured ham, pork shoulder, or pork loin was processed in accordance with one of the following criteria:

(1) The ham, if it is an Italian-type ham processed in accordance with paragraph (i)(1) of this section, was processed in a region which has submitted, through its veterinary services, to the Administrator, a written statement stating that it conducts a program to authorize persons to supervise activities specified under this section;

(2) The Serrano ham, processed in accordance with paragraph (i)(2) of this section, and came from any breed of large, white swine, including but not limited to Landrace, Pietrain, Duroc, Jersey, Hampshire, and Yorkshire breeds, and crosses of such breeds;

(3) The Iberian ham, processed in accordance with paragraph (i)(3) of this section, and came from a swine of the Iberico breed of pigs;

(4) The Iberian pork shoulder, processed in accordance with paragraph (i)(4) of this section, and came from a swine of the Iberico breed of pigs;

(5) The Iberian pork loin, if processed in accordance with paragraph (i)(5) of this section, and came from a swine of the Iberico breed of pigs.

(n) The whole dry-cured ham, pork shoulder, or pork loin came from a processing establishment that has entered into a cooperative service agreement executed by the operator of the establishment or a representative of the establishment and APHIS, and that pursuant to the cooperative service agreement is current in paying all costs for a veterinarian of APHIS to inspect the establishment (it is anticipated that such inspections will occur up to four times per year), including travel, salary, subsistence, administrative overhead, and other incidental expenses (including an excess baggage provision up to 150 pounds). In accordance with the terms of the cooperative service agreement, the operator of the processing establishment shall deposit with the Administrator, an amount equal to the approximate costs for a veterinarian to inspect the establishment one time, including travel, salary, subsistence, administrative overhead and other incidental expenses (including an excess baggage provision up to 150 pounds), and as funds from that amount are obligated, bills for costs incurred based on official accounting records will be issued to restore the deposit to its original level. Amounts to restore the deposit to its original level shall be paid within 14 days of receipt of such bills.

(o) The dry-cured ham, pork shoulder, or pork loin is accompanied at the time of importation into the United States by a certificate issued by a person authorized to issue such certificates by the veterinary services of the national government of the region of origin, stating:

(1) That all the provisions of this section have been complied with, including paragraphs (i) and (m) of this section;

(2) The paragraph of this section under which the dry-cured ham, pork shoulder, or pork loin was processed; and stating further that, if the product covered by the certificate:

(i) Is an Italian-type ham processed under paragraph (i)(1) of this section, it was processed for a minimum of 400 days;

(ii) Is a Serrano ham processed under paragraph (i)(2) of this section, it was:

(A) Processed for a minimum of 190 days in a region free of swine vesicular disease, in a facility authorized by the veterinary services of the national government of that region to process only meat from regions free of swine vesicular disease; or,

(B) Processed for a minimum of 560 days in any region, in a facility that may also process meat from regions where swine vesicular disease exists;

(iii) Is an Iberian ham processed under paragraph (i)(3) of this section, it was:

(A) Processed for a minimum of 365 days in a region free of swine vesicular disease, in a facility authorized by the veterinary services of the national government of that region to process only meat from regions free of swine vesicular disease; or,

(B) Processed for a minimum of 560 days in any region, in a facility that may also process meat from regions where swine vesicular disease exists;

(iv) Is a dry-cured pork shoulder, it was processed in accordance with paragraph (i)(4) of this section for a minimum of 240 days; or

(v) Is a dry-cured pork loin, it was processed in accordance with paragraph (i)(5) of this section for a minimum of 130 days.

(p) Whole hams, pork shoulders, and pork loins that have been dry-cured in accordance with paragraph (i) of this section may be transported to a facility in the same region for slicing and packaging in accordance with this paragraph.

(1) The slicing/packaging facility. (i) The slicing/packaging facility 16 must be inspected, prior to slicing and packaging any hams, pork shoulders, or pork loins in accordance with this paragraph, by an APHIS representative and determined by the Administrator to be capable of meeting the provisions of this paragraph.

(ii) The slicing/packaging facility must be either in a separate, physically detached building, or in a separate room in the facility where the whole ham, pork shoulder, or pork loin was dry-cured in accordance with paragraph (i) of this section. If the slicing/packaging facility is in a separate room, the room must have no direct access to areas in the facility where pork is cured and dried and it must be capable of being closed off from the rest of the facility so unauthorized individuals cannot enter.

(iii) The slicing/packaging facility, including all equipment used to handle pork and pork products, such as containers, work surfaces, slicing machines, and packaging equipment, must be cleaned and disinfected after sliced and packaged pork products that are not eligible for export to the United States leave the facility, and before whole dry-cured hams, pork shoulders, or pork intended for importation into the United States enter the facility for slicing and packaging. Cleaning and disinfecting must be adequate to ensure that disease agents of concern are killed or inactivated and that pork products intended for importation into the United States are not contaminated.

(iv) The slicing/packaging facility must maintain under lock and key for a minimum of 2 years, original records on each lot of whole dry-cured hams, pork shoulders, and pork loins entering the facility for slicing and packaging under this section, including:

(A) The approval number of the facility where the whole ham, shoulder, or loin was dry-cured in accordance with paragraph (i) of this section;

(B) The date the whole ham, shoulder, or loin started dry-curing;

(C) The date the whole ham, shoulder, or loin completed dry-curing;

(D) The date the whole ham, shoulder, or loin was sliced and packaged; and

(E) A copy of all certifications required under paragraph (p) of this section.

(v) Access to records required to be maintained under paragraph (p) of this section must be restricted to officials of the national government of the region of origin, representatives of the United States Government, and persons maintaining the records.

(vi) The operator of the slicing/packaging facility must have signed a cooperative service agreement with APHIS prior to receipt of the whole dry-cured hams, pork shoulders, or pork loins for slicing and packaging, stating that all hams, pork shoulders, or pork loins sliced and packaged at the facility for importation into the United States will be sliced and packaged only in accordance with this section.

(vii) The operator of the slicing/packaging facility must be current, in accordance with the terms of the cooperative service agreement signed with APHIS, in paying all costs for an APHIS representative to inspect the establishment, including travel, salary, subsistence, administrative overhead, and other incidental expenses.

(viii) The slicing/packaging facility must allow the unannounced entry into the establishment of APHIS representatives, or other persons authorized by the Administrator, for the purpose of inspecting the establishment and records of the establishment.

(ix) Workers at the slicing/packaging facility who handle pork or pork products in the facility must shower and put on a full set of clean clothes, or wait 24 hours after handling pork or pork products that are not eligible for importation into the United States, before handling dry-cured hams, pork shoulders, or pork loins in the slicing/packaging facility that are intended for importation into the United States.

(x) Pork products intended for importation into the United States may not be in the slicing/packaging facility at the same time as pork products not intended for exportation to the United States.

(2) Slicing and packaging and labeling procedures. (i) A full-time salaried veterinarian employed by the national government of the region of origin must inspect each lot of whole dry-cured hams, pork shoulders, and pork loins at the slicing/packaging facility, before slicing is begun, and must certify in English that it is eligible for importation into the United States in accordance with this section; and

(ii) Either a full-time salaried veterinarian employed by the national government of the region of origin, or, if the national government of the region of origin recognizes a local consortium as responsible for product quality, a representative of that local consortium, must certify in English that he or she personally supervised the entire process of slicing and packaging each lot of dry-cured hams, pork shoulders, and pork loins at the slicing/packaging facility; that each lot of dry-cured hams, pork shoulders, and pork loins was sliced and packaged in accordance with the requirements of this paragraph; and that the sliced and packaged pork ham, shoulder, or loin is the same dry-cured ham, pork shoulder, or pork loin certified under paragraph (p)(2)(i).

(iii) The sliced and packaged dry-cured pork ham, pork shoulder, or pork loin must be labeled with the date that processing of the meat under paragraph (i) of this section began, and with the date the meat was sliced and packaged.

(a) The importation of meat, meat products, and other edible products derived from bovines is prohibited with regard to BSE, except as provided in this section and in §§ 94.19, 94.20, 94.21, 94.22, and 94.23.

(b) The following commodities derived from bovines may be imported into the United States without restriction regarding BSE, provided that all other applicable requirements of this part are met:

(1) Milk and milk products;

(2) Boneless skeletal muscle meat (excluding mechanically separated meat) that:

(i) Is derived from bovines that were not, prior to slaughter, subjected to a pithing process or to stunning with a device injecting compressed air or gas into the cranial cavity, and that passed ante-mortem and post-mortem inspection;

(ii) Has been prepared in a manner to prevent contamination with SRMs; and

(iii) Is accompanied to the United States by an original certificate stating that the conditions of paragraphs (b)(2)(i) and (b)(2)(ii) of this section have been met. The certificate must be issued and signed by a full-time salaried veterinary officer of the national government of the exporting region or signed by a person authorized to issue such certificates by the veterinary services of the national government of the exporting region.

Meat, meat byproducts, and meat food products, as defined by FSIS in 9 CFR 301.2-except that those terms as applied to bison shall have a meaning comparable to those provided in 9 CFR 301.2 with regard to cattle, and other than boneless skeletal meat that meets the conditions of § 94.18(b)(2)—may be imported from a region of negligible risk for BSE, as defined in § 92.1 of this subchapter, if the following conditions and all other applicable requirements of this part are met:

(a) The commodities were exported from a region of negligible risk for BSE.

(b) If BSE has been diagnosed in one or more indigenous bovines in the region of negligible risk, the commodities were derived from bovines subject to a ban on the feeding to ruminants of meat-and-bone meal or greaves derived from ruminants.

(c) The commodities were derived from bovines that passed ante-mortem and post-mortem inspections.

(d) The commodities are accompanied by an original certificate stating that the exporting region is classified by APHIS as a region of negligible risk for BSE and that the conditions of paragraphs (a) through (c) of this section, as applicable, have been met. The certificate must be issued and signed by a full-time salaried veterinary officer of the national government of the exporting region, or signed by a person authorized to issue such certificates by the veterinary services of the national government of the exporting region.

Meat, meat byproducts, and meat food products, as defined by FSIS in 9 CFR 301.2—except that those terms as applied to bison shall have a meaning comparable to those provided in 9 CFR 301.2 with regard to cattle, and other than boneless skeletal meat that meets the conditions of § 94.18(b)(2)—may be imported from a region of controlled risk for BSE, as defined in § 92.1 of this subchapter, if the following conditions and all other applicable requirements of this part are met:

(a) The commodities were exported from a region of controlled risk for BSE.

(b) The commodities were derived from bovines that passed ante-mortem and post-mortem inspections.

(c) The commodities were derived from bovines that were not subjected to a stunning process, prior to slaughter, with a device injecting compressed air or gas into the cranial cavity, or to a pithing process.

(d) The commodities were produced and handled in a manner that ensured that such commodities do not contain and are not contaminated with either of the following:

(1) SRMs from regions of controlled risk for BSE; or

(2) Mechanically separated meat from the skull and vertebral column from bovines 30 months of age or older.

(e) The commodities are accompanied by an original certificate stating that the exporting region is classified by APHIS as a region of controlled risk for BSE, and that the conditions of this section have been met. The certificate must be issued and signed by a full-time salaried veterinary officer of the national government of the exporting region, or signed by a person authorized to issue such certificates by the veterinary services of the national government of the exporting region.

Meat, meat byproducts, and meat food products, as defined by FSIS in 9 CFR 301.2-except that those terms as applied to bison shall have a meaning comparable to those provided in 9 CFR 301.2 with regard to cattle, and other than boneless skeletal meat that meets the conditions of § 94.18(b)(2)—may be imported from regions of undetermined risk for BSE, as defined in § 92.1 of this subchapter, if the following conditions and all other applicable requirements of this part are met:

(a) The commodities were derived from bovines that have never been fed meat-and-bone meal or greaves derived from ruminants.

(b) The commodities were derived from bovines that passed ante-mortem and post-mortem inspections.

(c) The commodities were derived from bovines that were not subjected to a stunning process, prior to slaughter, with a device injecting compressed air or gas into the cranial cavity, or to a pithing process.

(d) The commodities were produced and handled in a manner that ensured that such commodities do not contain and are not contaminated with any of the following:

(1) SRMs from regions of undetermined risk for BSE; or

(2) Mechanically separated meat from the skull and vertebral column from bovines over 12 months of age.

(e) The commodities are accompanied by an original certificate stating that the exporting region is a region of undetermined risk for BSE and that the conditions of this section have been met. The certificate must be issued and signed by a full-time salaried veterinary officer of the national government of the exporting region, or signed by a person authorized to issue such certificates by the veterinary services of the national government of the exporting region.

The meat or dressed carcass (eviscerated and the head is removed) is derived from a wild bovine that has been legally harvested in the wild, as verified by proof such as a hunting license, tag, or the equivalent that the hunter must show to the authorized inspector.

(a) The importation of gelatin derived from bovines is prohibited because of BSE, unless:

(1) The gelatin meets the requirements of either paragraph (b), (c), or (d), as well as the requirements of paragraph (e) of this section and all other applicable requirements of this part; or

(2) The gelatin is authorized importation under paragraph (f) of this section and meets all other applicable requirements of this part.

(b) The gelatin is derived from hides and skins, provided the gelatin has not been commingled with materials ineligible for entry into the United States.

(c) The gelatin is derived from the bones of bovines and originates in a region of negligible risk for BSE.

(d) The gelatin is derived from the bones of bovines, originates in a region of controlled risk or undetermined risk for BSE, and meets the requirements of paragraphs (d)(1) through (d)(4) of this section:

(1) The bones from which the gelatin was derived were derived from bovines that passed ante-mortem and post-mortem inspection.

(2) The bones from which the gelatin was derived did not include the skulls of bovines or the vertebral column of bovines 30 months of age or older.

(3) The bones were subjected to a process that includes all of the following steps, or to a process at least as effective in reducing BSE infectivity:

(i) Degreasing;

(ii) Acid demineralization;

(iii) Acid or alkaline treatment;

(iv) Filtration; and

(v) Sterilization at 138 °C (280.4 °F) or greater for a minimum of 4 seconds; and

(4) The gelatin has not been commingled with materials ineligible for entry into the United States.

(e) The gelatin is accompanied to the United States by an original certificate signed by a full-time salaried veterinary officer of the national government of the exporting region, or issued by a veterinarian designated by the national government of the exporting region and endorsed by a full-time salaried veterinary officer of the national government of the exporting region, representing that the veterinarian issuing the certificate was authorized to do so. The certificate must state that the requirements of paragraph (b), (c), or (d) of this section, as applicable, have been met and, for gelatin other than that described in paragraph (b) of this section, must indicate the BSE risk classification of the exporting region.

(f) The Administrator determines that the gelatin will not come into contact with ruminants in the United States and can be imported under conditions that will prevent the introduction of BSE into the United States, and the person importing the gelatin has obtained a United States Veterinary Permit for Importation and Transportation of Controlled Materials and Organisms and Vectors. To apply for a permit, file a permit application on VS Form 16-3 (available from Strategy and Policy, Veterinary Services, APHIS, 4700 River Road, Unit 38, Riverdale, MD 20737-1231, or electronically at https://efile.aphis.usda.gov/s/vs-permitting-assistant). The application for such a permit must state the intended use of the gelatin and name and address of the consignee in the United States.

Gelatin derived from horses, swine, or non-bovine ruminants must be accompanied at the time of importation into the United States by an official certificate issued by a veterinarian employed by the national government of the region of origin. The official certificate must state the species of animal from which the gelatin is derived.

(a) Poultry meat and products. In addition to meeting all other applicable provisions of this part, poultry meat and poultry products, including eggs and egg products (other than hatching eggs) imported from the APHIS-defined European Poultry Trade Region must meet the following conditions:

(1) The poultry meat and products must not have been derived from birds and poultry that were in any of the following regions or zones, unless the birds and poultry were slaughtered after the periods described, or unless the poultry meat and products are accompanied by a certificate specifying that the articles were cooked and processed in accordance with the regulations in § 94.6(b)(3) or (b)(4):

(i) Any region when the region was classified in § 94.6(a)(1)(i) as one in which Newcastle disease is considered to exist, or any region when the region was listed in accordance with § 94.6(a)(2)(i) as one in which HPAI is considered to exist, except for the APHIS-defined European Poultry Trade Region;

(ii) A restricted zone in the APHIS-defined European Poultry Trade Region established because of detection of Newcastle disease or HPAI in commercial poultry, from the time of detection until the designation of the zone as a restricted zone is removed by the competent veterinary authority of the country or until 3 months (90 days) following depopulation of the poultry on affected premises in the restricted zone and the cleaning and disinfection of the last affected premises in the zone, whichever is later; or

(iii) A restricted zone in the APHIS-defined European Poultry Trade Region established because of detection of Newcastle disease or HPAI in racing pigeons, backyard flocks, or wild birds, from the time of detection until the designation of the zone as a restricted zone is removed by the competent veterinary authority of the country.

(2) The poultry meat and products must not have been commingled with poultry meat and products derived from other birds and poultry that were in any of the regions or zones described in paragraphs (a)(1)(i) through (a)(1)(iii) of this section. Additionally, the poultry meat and products must not have been derived from poultry that were commingled with other poultry that were in any of the regions or zones described in paragraphs (a)(1)(i) through (a)(1)(iii) of this section.

(3) No equipment or materials used in transporting the birds or poultry from which the poultry meat and products were derived from the farm of origin to the slaughtering establishment may have been used previously for transporting live birds or poultry that do not meet the requirements of § 94.28(b), unless the equipment and materials have first been cleaned and disinfected.

(4) The poultry meat and products, including eggs and egg products (other than hatching eggs) must be accompanied by a certificate issued by an official of the competent veterinary authority of the APHIS-defined European Poultry Trade Region country who is authorized to issue the inspection certificate required by § 93.205 of this subchapter, stating that the applicable provisions of paragraphs (a)(1) through (a)(3) of this section have been met. The certification for poultry meat and products may be placed on the foreign meat inspection certificate required by § 381.196 of this title or may be contained in a separate document.

(b) Live birds and poultry. In addition to meeting all other applicable provisions of this title, live birds and poultry, except hatching eggs, imported from the APHIS-defined European Poultry Trade Region must meet the following conditions:

(1) The birds and poultry must not have been in any of the following regions or zones, unless the birds and poultry are exported to the United States after the periods described.

(i) Any region when the region was classified in § 94.6(a)(1)(i) as one in which Newcastle disease is considered to exist, or any region when the region was listed in accordance with § 94.6(a)(2)(i) as one in which HPAI is considered to exist, except for the APHIS-defined European Poultry Trade Region;

(ii) A restricted zone in the APHIS-defined European Poultry Trade Region established because of detection of Newcastle disease or HPAI in commercial poultry, from the time of detection until the designation of the zone as a restricted zone is removed by the competent veterinary authority of the country or until 3 months (90 days) following depopulation of the poultry on affected premises in the restricted zone and the cleaning and disinfection of the last affected premises in the zone, whichever is later; or

(iii) A restricted zone in the APHIS-defined European Poultry Trade Region established because of detection of Newcastle disease or HPAI in racing pigeons, backyard flocks, and wild birds, from the time of detection until the designation of the zone as a restricted zone is removed by the competent veterinary authority of the country.

(2) The birds and poultry must not have been commingled with other birds or poultry that have at any time been in any of the regions or zones described in paragraphs (b)(1)(i) through (b)(1)(iii) of this section.

(3) No equipment or materials used in transporting the birds and poultry may have been used previously for transporting birds or poultry that do not meet the requirements of this paragraph, unless the equipment and materials have first been cleaned and disinfected.

(4) The birds and poultry must be accompanied by a certificate issued by an official of the competent veterinary authority of the country who is authorized to issue the inspection certificate required by § 93.205 of this subchapter, stating that the applicable provisions of paragraphs (b)(1) through (b)(3) of this section have been met. The certification may be placed on the foreign meat inspection certificate required by § 381.196 of this title or may be contained in a separate document.

(c) Hatching eggs. Hatching eggs intended for import from the APHIS-defined European Poultry Trade Region are subject to all applicable provisions of paragraph (b) of this section, except that such hatching eggs may be moved through zones established because of detection of HPAI within the APHIS-defined European Poultry Trade Region provided that the hatching eggs are transported under official seal and accompanied by a certificate as indicated in paragraph (b)(4) of this section stating that the applicable provisions of paragraph (b) have been met. The import permit will require the seal number to be listed on the health certificate that accompanies the shipment and the veterinarian who places the seal will be required to sign his or her name under the seal number. Seals must not be broken until the shipment reaches its U.S. port of entry. Hatching egg shipment with seals that are not intact will be rejected upon inspection at the U.S. port of entry.

(d) Presentation of certificates. The certificates required by paragraphs (a)(4), (b)(4), and (c) of this section must be presented by the importer to an authorized inspector at the port of arrival, upon arrival of the birds, poultry, hatching eggs, or poultry meat and products at the port.

Notwithstanding any other provisions of this part, fresh (chilled or frozen) beef from a region in Argentina located north of Patagonia South and Patagonia North B, referred to as Northern Argentina (the region sometimes referred to as Patagonia North A is included in Northern Argentina); fresh (chilled or frozen) beef from a region in Brazil composed of the States of Bahia, Distrito Federal, Espírito Santo, Goiás, Mato Grosso, Mato Grosso do Sul, Minas Gerais, Paraná, Rio Grande do Sul, Rio de Janeiro, Rondônia, São Paulo, Sergipe, and Tocantins; fresh (chilled or frozen) beef from Paraguay; and fresh (chilled or frozen) beef and ovine meat from Uruguay may be exported to the United States under the following conditions:

(a) The meat is:

(1) Beef from animals that have been born, raised, and slaughtered in the exporting regions of Argentina or Brazil or in Paraguay; or

(2) Beef or ovine meat from Uruguay derived from animals that have been born, raised, and slaughtered in Uruguay.

(b) Foot-and-mouth disease has not been diagnosed in the exporting region of Argentina (for beef from Argentina), the exporting region of Brazil (for beef from Brazil), in Paraguay (for beef from Paraguay), or in Uruguay (for beef or ovine meat from Uruguay) within the previous 12 months.

(c) The meat comes from bovines or sheep that originated from premises where foot-and-mouth disease has not been present during the lifetime of any bovines and sheep slaughtered for the export of beef and ovine meat to the United States.

(d) The meat comes from bovines or sheep that were moved directly from the premises of origin to the slaughtering establishment without any contact with other animals.

(e) The meat comes from bovines or sheep that received ante-mortem and post-mortem veterinary inspections, paying particular attention to the head and feet, at the slaughtering establishment, with no evidence found of vesicular disease.

(f) The meat consists only of bovine parts or ovine parts that are, by standard practice, part of the animal's carcass that is placed in a chiller for maturation after slaughter and before removal of any bone, blood clots, or lymphoid tissue. The bovine and ovine parts that may not be imported include all parts of the head, feet, hump, hooves, and internal organs.

(g) All bone and visually identifiable blood clots and lymphoid tissue have been removed from the meat; except that bone-in ovine meat from Uruguay may be exported to the United States under the following conditions:

(1) The meat must be derived from select lambs that have never been vaccinated for FMD;

(2) The select lambs must be maintained in a program approved by the Administrator. Lambs in the program must:

(i) Be segregated from other FMD-susceptible livestock at a select lamb facility operated under the authority of the national veterinary authority of Uruguay;

(ii) Be subjected to an FMD testing scheme approved by the Administrator; and

(iii) Be individually identified with official unique identification that is part of a national traceability system sufficient to ensure that only the products of select lambs meeting all required criteria are exempt from the deboning requirement.

(3) Select lambs and their products must not be commingled with other animals and their products within the slaughter facility.

(h) The meat has not been in contact with meat from regions other than those listed in § 94.1(a).

(i) The meat came from carcasses that were allowed to maturate at 40 to 50 °F (4 to 10 °C) for a minimum of 24 hours after slaughter and that reached a pH below 6.0 in the loin muscle at the end of the maturation period. Measurements for pH must be taken at the middle of both longissimus dorsi muscles. Any carcass in which the pH does not reach less than 6.0 may be allowed to maturate an additional 24 hours and be retested, and, if the carcass still has not reached a pH of less than 6.0 after 48 hours, the meat from the carcass may not be exported to the United States.

(j) An authorized veterinary official of the government of the exporting region certifies on the foreign meat inspection certificate that the above conditions have been met.

(k) The establishment in which the bovines and sheep are slaughtered allows periodic on-site evaluation and subsequent inspection of its facilities, records, and operations by an APHIS representative.

Notwithstanding any other provisions of this part, poultry meat and other poultry products from the States of Sinaloa and Sonora, Mexico, may be imported into the United States under the following conditions:

(a) The poultry meat or other poultry products are derived from poultry born and raised in Sinaloa or Sonora and slaughtered in Sinaloa or Sonora at a federally inspected slaughter plant under the direct supervision of a full-time salaried veterinarian of the Government of Mexico, and the slaughter plant must be approved to export poultry meat and other poultry products to the United States in accordance with 9 CFR 381.196.

(b) If processed, the poultry meat or other poultry products were processed in either Sinaloa or Sonora, Mexico, in a federally inspected processing plant that is under the direct supervision of a full-time salaried veterinarian of the Government of Mexico.

(c) The poultry meat or other poultry products have not been in contact with poultry from any State in Mexico other than Sinaloa or Sonora or with poultry from any other region not listed in § 94.6 as a region where Newcastle disease is not known to exist.

(d) The foreign meat inspection certificate accompanying the poultry meat or other poultry products (required by 9 CFR 381.197) includes statements certifying that the requirements in paragraphs (a), (b), and (c) of this section have been met and, if applicable, listing the numbers of the seals required by paragraph (e)(1) of this section.

(e) The shipment of poultry meat or other poultry products has not been in any State in Mexico other than Sinaloa or Sonora or in any other region not listed in § 94.6 as a region where Newcastle disease is not known to exist, unless:

(1) The poultry meat or other poultry products arrive at the U.S. port of entry in shipping containers bearing intact, serially numbered seals that were applied at the federally inspected slaughter plant by a full-time salaried veterinarian of the Government of Mexico, and the seal numbers correspond with the seal numbers listed on the foreign meat inspection certificate; or

(2) The poultry meat or other poultry products arrive at the U.S. port of entry in shipping containers bearing seals that have different numbers than the seal numbers on the foreign meat inspection certificate, but, upon inspection of the hold, compartment, or container and all accompanying documentation, an APHIS representative is satisfied that the poultry containers were opened and resealed en route by an appropriate official of the Government of Mexico and the poultry meat or other poultry products were not contaminated or exposed to contamination during movement from Sinaloa or Sonora to the United States.

(a) Pork and pork products. In addition to meeting all other applicable provisions of this part, fresh pork and pork products imported from the APHIS-defined European CSF region must meet the following conditions:

(1) The pork or pork products must not have been derived from swine that were in any of the following regions or zones, unless the swine were slaughtered after the periods described:

(i) Any region when the region was classified under §§ 94.9(a) and 94.10(a) as a region in which classical swine fever is known to exist, except for the APHIS-defined European CSF region;

(ii) A restricted zone in the APHIS-defined European CSF region established because of detection of classical swine fever in domestic swine, from the time of detection until the designation of the zone as a restricted zone is removed by the competent veterinary authority or until 6 months following depopulation of the swine on affected premises in the restricted zone and the cleaning and disinfection of the last affected premises in the zone, whichever is later; or

(iii) A restricted zone in the APHIS-defined European CSF region established because of the detection of classical swine fever in wild boar, from the time of detection until the designation of the zone as a restricted zone is removed by the competent veterinary authority.

(2) The pork and pork products must not have been commingled with pork or pork products derived from other swine that were in any of the regions or zones described in paragraphs (a)(1)(i) through (a)(1)(iii) of this section, unless the other swine were slaughtered after the periods described. Additionally, the pork and pork products must not have been derived from swine that were commingled with other swine that were in any of the regions or zones described in paragraphs (a)(1)(i) through (a)(1)(iii) of this section, unless the swine from which the pork or pork products were derived were slaughtered after the periods described.

(3) The swine from which the pork or pork products were derived must not have transited any region or zone described in paragraphs (a)(1)(i) through (a)(1)(iii) of this section, unless the swine were moved directly through the region or zone in a sealed means of conveyance with the seal determined to be intact upon arrival at the point of destination, or unless the swine were slaughtered after the periods described.

(4) No equipment or materials used in transporting the swine from which the pork or pork products were derived from the farm of origin to the slaughtering establishment may have been used previously for transporting swine that do not meet the requirements of this section, unless the equipment and materials have first been cleaned and disinfected.

(5) The pork and pork products must be accompanied by a certificate issued by an official of the competent veterinary authority who is authorized to issue the foreign meat inspection certificate required by § 327.4 of this title, stating that the applicable provisions of paragraphs (a)(1) through (a)(4) of this section have been met. 19

(b) Live swine. In addition to meeting all other applicable provisions of this title, live swine imported from the APHIS-defined European CSF region must meet the following conditions:

(1) The swine must be breeding swine.

(2) The swine must not have been in any of the following regions or zones, unless the swine are exported to the United States after the periods described:

(i) Any region when the region was classified under §§ 94.9(a) and 94.10(a) as a region in which classical swine fever is known to exist, except for the APHIS-defined European CSF region;

(ii) A restricted zone in the APHIS-defined European CSF region established because of the detection of classical swine fever in domestic swine, from the time of detection until the designation of the zone as a restricted zone is removed by the competent veterinary authority or until 6 months following depopulation of the swine on affected premises in the restricted zone and the cleaning and disinfection of the last affected premises in the zone, whichever is later; or

(iii) A restricted zone in the APHIS-defined European CSF region established because of the detection of classical swine fever in wild boar, from the time of detection until the designation of the zone as a restricted zone is removed by the competent veterinary authority.

(3) The swine must not have been commingled with other swine that have at any time been in any of the regions or zones described in paragraphs (b)(2)(i) through (b)(2)(iii) of this section, unless the swine are exported after the periods described.

(4) The swine must not have transited any region or zone described in paragraphs (b)(2)(i) through (b)(2)(iii) of this section, unless the swine were moved directly through the region or zone in a sealed means of conveyance with the seal determined to be intact upon arrival at the point of destination, or unless the swine are exported after the periods described;

(5) No equipment or materials used in transporting the swine may have been used previously for transporting swine that do not meet the requirements of this section, unless the equipment and materials have first been cleaned and disinfected.

(6) The swine must be accompanied by a certificate issued by a salaried veterinary officer of the competent veterinary authority, stating that the conditions of paragraphs (b)(1) through (b)(5) of this section have been met. 20

(c) The certificates required by paragraphs (a)(5) and (b)(6) of this section must be presented by the importer to an authorized inspector at the port of arrival, upon arrival of the swine, pork, or pork products at the port.

(a) Live swine, pork, or pork products and ship stores, airplane meals, and baggage containing pork or pork products, other than those articles regulated under part 95 or part 96 of this chapter, may not be imported into the United States from a region listed under paragraph (a)(2) of this section unless the requirements in this section, in addition to other applicable requirements of part 93 of this chapter and part 327 of this title, are met.

(1) The regions listed under paragraph (a)(2) of this section have been declared free of classical swine fever (CSF) by APHIS in accordance with §§ 94.9(a) and 94.10(a) but either supplement their pork supplies with fresh (chilled or frozen) pork imported from regions considered to be affected by CSF, or supplement their pork supplies with pork from CSF-affected regions that is not processed in accordance with the requirements of this part, or share a common land border with CSF-affected regions, or import live swine from CSF-affected regions under conditions less restrictive than would be acceptable for importation into the United States. Thus, the live swine, pork, or pork products from those regions may be commingled with live swine, pork, or pork products from CSF-affected regions, resulting in a risk of CSF introduction into the United States.

(2) A list of regions whose live swine, pork, and pork products are regulated under this section is maintained on the APHIS website at https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/animal-and-animal-product-import-information/animal-health-status-of-regions. Copies of the list are also available via postal mail upon request to Regionalization Evaluation Services, Strategy and Policy, Veterinary Services, Animal and Plant Health Inspection Service, 4700 River Road, Unit 38, Riverdale, Maryland 20737; [email protected].

(3) APHIS will add a region to the list of those whose live swine, pork, and pork products are regulated under this section after conducting an evaluation of the region and determining that one or more of the circumstances described in paragraph (a)(1) of this section exists. APHIS will remove a region from the list upon conducting an evaluation of the region and determining that the circumstances in paragraph (a)(1) of this section no longer exist or upon determining that classical swine fever exists in the region.

(b) Live swine. The swine must be accompanied by a certification issued by a full-time salaried veterinary officer of the national government of the region of export. Upon arrival of the swine in the United States, the certification must be presented to an authorized inspector at the port of arrival. The certification must identify both the exporting region and the region of origin as a region listed under §§ 94.9 and 94.10 as free of CSF at the time the swine were in the region and must state that:

(1) The swine have not lived in a region classified under §§ 94.9 and 94.10 as a region in which CSF is known to exist;

(2) The swine have never been commingled with swine that have been in a region that is classified under §§ 94.9 and 94.10 as a region in which CSF is known to exist;

(3) The swine have not transited a region classified under §§ 94.9 and 94.10 as a region in which CSF is known to exist unless moved directly through the region to their destination in a sealed means of conveyance with the seal intact upon arrival at the point of destination; and

(4) The conveyances or materials used in transporting the swine, if previously used for transporting swine, have been cleaned and disinfected in accordance with the requirements of § 93.502 of this chapter.

(c) Pork or pork products. The pork or pork products must be accompanied by a certification issued by a full-time salaried veterinary officer of the national government of the region of export. Upon arrival of the pork or pork products in the United States, the certification must be presented to an authorized inspector at the port of arrival. The certification must identify both the exporting region and the region of origin of the pork or pork products as a region listed under §§ 94.9 and 94.10 as free of CSF at the time the pork or pork products were in the region and must state that:

(1) The pork or pork products were derived from swine that were born and raised in a region listed under §§ 94.9 and 94.10 as free of CSF and were slaughtered in such a region at a federally inspected slaughter plant that is under the direct supervision of a full-time salaried veterinarian of the national government of that region and that is eligible to have its products imported into the United States under the Federal Meat Inspection Act (21 U.S.C. 601 et seq.) and the regulations in § 327.2 of this title;

(2) The pork or pork products were derived from swine that have not lived in a region classified under §§ 94.9 and 94.10 as a region in which CSF is known to exist;

(3) The pork or pork products have never been commingled with pork or pork products that have been in a region that is classified under §§ 94.9 and 94.10 as a region in which CSF is known to exist;

(4) The pork or pork products have not transited through a region classified under §§ 94.9 and 94.10 as a region in which CSF is known to exist unless moved directly through the region to their destination in a sealed means of conveyance with the seal intact upon arrival at the point of destination; and

(5) If processed, the pork or pork products were processed in a region listed under §§ 94.9 and 94.10 as free of CSF in a federally inspected processing plant that is under the direct supervision of a full-time salaried veterinary official of the national government of that region.

Argentina and the Mexican States of Campeche, Quintana Roo, and Yucatan, which are declared in § 94.6(a)(1) to be free of Newcastle disease, supplement their meat supply by the importation of fresh (chilled or frozen) poultry meat from regions designated in § 94.6(a) as regions where Newcastle disease is considered to exist, have a common land border with regions where Newcastle disease is considered to exist, or import live poultry from regions where Newcastle disease is considered to exist under conditions less restrictive than would be acceptable for importation into the United States. Thus, even though the Department has declared such regions to be free of Newcastle disease, live poultry originating in such free regions may be commingled with live poultry originating in an Newcastle disease-affected region and the meat and other animal products produced in such free regions may be commingled with the fresh (chilled or frozen) meat of animals from an Newcastle disease-affected region, resulting in an undue risk of introducing Newcastle disease into the United States. Therefore, live poultry, poultry meat and other poultry products, and ship stores, airplane meals, and baggage containing such meat or animal products originating in the free regions listed in this section may not be imported into the United States unless the following requirements, in addition to all other applicable requirements of part 93 of this chapter and of chapter III of this title, are met:

(a) Additional certification. Live poultry, poultry meat, and other poultry products from any region designated in this section must be accompanied by an additional certification by a full-time salaried veterinary officer of the national Government of the exporting region. Upon arrival of the live poultry, poultry meat, or other poultry product in the United States, the certification must be presented to an authorized inspector at the port of arrival.

(b) Live poultry. The certification accompanying live poultry must identify the exporting region of the poultry as a region designated in § 94.6(a) as free of Newcastle disease and highly pathogenic avian influenza at the time the poultry were in the region and must state that:

(1) The poultry have not been in contact with poultry or poultry products from any region where Newcastle disease is considered to exist;

(2) The poultry have not lived in a region where Newcastle disease is considered to exist; and

(3) The poultry have not transited through a region where Newcastle disease is considered to exist unless moved directly through the region in a sealed means of conveyance with the seal intact upon arrival at the point of destination.

(c) Poultry meat or other poultry products. The certification accompanying poultry meat or other poultry products must state that:

(1) The poultry meat or other poultry products are derived from poultry that meet all requirements of this section and that have been slaughtered in a region designated in § 94.6(a) as free of Newcastle disease and highly pathogenic avian influenza at a federally inspected slaughter plant that is under the direct supervision of a full-time salaried veterinarian of the national Government of the exporting region and that is approved to export poultry meat and other poultry products to the United States in accordance with § 381.196 of this title;

(2) The poultry meat or other poultry products have not been in contact with poultry meat or other poultry products from any region where Newcastle disease is considered to exist;

(3) The poultry meat or other poultry products have not transited through a region where Newcastle disease is considered to exist unless moved directly through the region in a sealed means of conveyance with the seal intact upon arrival at the point of destination; and

(4) If processed, the poultry meat or other poultry products were processed in a region designated in § 94.6(a) as free of Newcastle disease and highly pathogenic avian influenza in a federally inspected processing plant that is under the direct supervision of a full-time salaried veterinarian of the national Government of the exporting region.