For purposes of this part, the following terms mean:

Accredited veterinarian. A veterinarian approved by the Administrator in accordance with the provisions of part 161 of this title to perform functions specified in parts 1, 2, 3, and 11 of subchapter A, and subchapters B, C, and D of this chapter, and to perform functions required by cooperative state-federal disease control and eradication programs.

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

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

Approved differential pseudorabies test. Any test for the diagnosis of pseudorabies that: (a) Can distinguish vaccinated swine from infected swine; (b) Is produced under license from the Secretary of Agriculture under the Virus-Serum-Toxin Act of March 4, 1913, and subsequent amendments (21 U.S.C. 151 et seq.) with indications for use in the Cooperative State-Federal Pseudorabies Eradication Program; and (c) Is conducted in a laboratory approved by the Administrator.1

Approved livestock market. A stockyard, livestock market, buying station, concentration point or any other premises under State or Federal veterinary supervision where swine are assembled for sale or sale purposes, and which has been approved by the Administrator under §71.20 of this chapter.2 3

Certificate. An official document issued by an Animal and Plant Health Inspection Service representative, State representative, or accredited veterinarian for and prior to the interstate movement of swine that are not known to be infected with or exposed to pseudorabies, and are not pseudorabies vaccinates, except for official gene-altered pseudorabies vaccinates vaccinated with a glycoprotein I (gpI) deleted gene-altered pseudorabies vaccine or from a qualified negative gene-altered vaccinated herd. The document must state: (a) The number and description of the swine to be moved; (b) That the swine to be moved are not known to be infected with or exposed to pseudorabies; (c) The purpose for which the swine are to be moved; (d) The points of origin and destination; (e) The consignor and consignee; and (f) Any additional information required by this part.

Common ground. The ground, areas, buildings or equipment communally shared by any specific group or groups of livestock.

Contact. Direct access to other swine, their excrement, or discharges; or sharing a building with a common ventilation system with other swine, or being within ten feet of other swine if not sharing a building with a common ventilation system.

Exposed livestock. Any livestock that has been in contact with an animal infected with pseudorabies, including all livestock in a known infected herd; except that livestock, other than swine, that have not been exposed to a clinical case of the disease for a period of 10 consecutive days shall no longer be considered to be exposed livestock.

Exposed swine. Any swine that has been in contact with an animal infected with pseudorabies, including all swine in a known infected herd.

Farm of origin. A farm where the swine were born, or on which they have resided for at least 90 consecutive days immediately prior to the interstate shipment.

Feedlot. A premises where swine are fed physically separated from swine kept for breeding or other purposes and from which such swine are moved directly to a recognized slaughtering establishment or directly through one or more slaughter markets and then directly to a recognized slaughtering establishment, quarantined herd, or quarantined feedlot.

Herd. Any group of livestock maintained on common ground for any purpose, or two or more groups of livestock under common ownership or supervision, geographically separated, but which have an interchange or movement of animals without regard to whether the animals are infected with or exposed to pseudorabies.

Infected livestock. Any livestock determined to be infected with pseudorabies by an official pseudorabies test, or diagnosed by an official pseudorabies epidemiologist as having pseudorabies.

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

Isolation. Separation of swine by a physical barrier in such a manner that other swine do not have access to the isolated swine's body, excrement, or discharges; not allowing the isolated swine to share a building with a common ventilation system with other swine; and not allowing the isolated swine to be within ten feet of other swine if not sharing a building with a common ventilation system.

Known infected herd. Any herd in which any livestock has been determined to be infected with pseudorabies by an official pseudorabies test, an approved differential pseudorabies test, or diagnosed by an official pseudorabies epidemiologist as having pseudorabies.

(a) A herd of livestock, other than swine, shall no longer be classified as a known infected herd after 10 days since the last clinical case of pseudorabies in the herd.

(b) A herd of swine which has been released from pseudorabies quarantine in accordance with the following provisions shall no longer be classified as a known infected herd if:

(1) All swine positive to an official pseudorabies test have been removed from the premises; all swine which remain in the herd, except swine nursing from their mothers, are subjected to an official pseudorabies serologic test and found negative 30 days or more after removal of swine positive to an official pseudorabies test; and no livestock on the permises have shown clinical signs of pseudorabies after removal of the postive swine; or

(2) All swine have been depopulated for 30 days and the herd premises have been cleaned and disinfected in accordance with §85.13; or

(3) In a herd of swine in which swine are positive to an official pseudorabies serologic test but no swine are postive at titers greater than 1:8, all titered swine are subjected to another official pseudorabies serologic test and found negative; and all other swine in the herd which an epidemiologist, approved by the State animal health official and the Veterinarian in Charge, requires to be subjected to an official pseudorabies serologic test are tested and found negative.4

(4) In a herd of swine containing official gene-altered pseudorabies vaccinates:

(i) All vaccinates have been vaccinated with the same official gene-altered pseudorabies vaccine; and

(ii) All swine positive to an approved differential pseudorabies test have been gone from the herd for at least 60 days; and

(iii) No livestock on the same premises as the herd have shown clinical signs of pseudorabies since removal of the positive swine; and

(iv) The herd has been tested for pseudorabies and found negative in accordance with one of the following two provisions:

(A) All swine in the herd, except suckling swine, are tested with an approved differential pseudorabies test. If all tested swine are found negative, no further testing is required. If any swine test positive, they may be retested with an approved differential pseudorabies test within 30 days of the first test if they are isolated from the remainder of the herd until the retest shows them to be negative.

(B) All swine in the herd over 6 months of age and a random sample of 30 or more swine in each segregated group of swine in the herd between 2 and 6 months of age are tested with an approved differential pseudorabies test. Not less than 30 days nor more than 60 days after this first test, another random sample of 30 or more swine in each segregated group of swine in the herd between 2 and 6 months of age is tested with an approved differential pseudorabies test. If all swine are negative on these tests, no further testing is required. If any swine test positive on either of these tests, the positive swine may be retested with an approved differential test within 30 days of the initial test if they are isolated from the remainder of the herd until the retest shows them to be negative.

Livestock. Swine, cattle, sheep or goats.

Moved. Shipped, transported, or otherwise moved, or delivered or received for movement by land, water, or air.

Official gene-altered pseudorabies vaccinate. Swine vaccinated with an official gene-altered pseudorabies vaccine, in accordance with directions on the label.

Official gene-altered pseudorabies vaccine. Any official pseudorabies vaccine for which there is an approved differential pseudorabies test.

Official pseudorabies epidemiologist. A state or federally employed veterinarian designated by the State animal health official and the veterinarian in charge to investigate and diagnose pseudorabies in livestock.

Official pseudorabies serologic test. An official pseudorabies test, as defined in this section, conducted on swine serum to detect the presence or absence of pseudorabies antibodies.

Official pseudorabies test. Any test for the diagnosis of pseudorabies approved by the Administrator conducted in a laboratory approved by the Administrator as listed in a Veterinary Services Notice listing such laboratories.5 The following tests for the diagnosis of pseudorabies have been approved by the Administrator: 1. Microtitration Serum-Virus Neutralization Test; 2. Virus Isolation and Identification Test; 3. Fluorescent Antibody Tissue Section Test; 4. Enzyme-Linked Immunosorbent Assay (ELISA) Test, except for approved differential pseudorabies tests other than the glycoprotein I (gpI) ELISA test; 5. Latex Agglutination Test (LAT); and 6. Particle Concentration Fluorescence Immunoassay (PCFIA) Test, including the gpI PCFIA test.6 State, Federal, and University laboratories will be approved by the Administrator following the determination by him that the laboratory: (a) Has personnel trained at the Veterinary Services Diagnostic Laboratory, Ames, Iowa, assigned to supervise the test, (b) follows standard test protocol, (c) meets check test proficiency requirements, and (d) will report all test results to State and Federal animal health officials.7

Official pseudorabies vaccine. Any pseudorabies virus vaccine produced under license from the Secretary of Agriculture under the Virus, Serum and Toxin Act of March 4, 1913, and any legislation amendatory thereof (21 U.S.C. 151 et seq.).

Official vaccinate. Any swine which have been: (a) Vaccinated with an official pseudorabies vaccine by an accredited veterinarian or a State or Federal veterinarian in accordance with recommendations on the vaccine label and the laws and regulations of the State in which the swine are vaccinated; (b) identified by a numbered pink eartag approved by the State in which such swine are vaccinated;8 and (c) reported as official vaccinates at the time of vaccination to the State animal health official.

Owner-shipper statement. A statement signed by the owner or shipper of swine which states: (a) The number of swine to be moved; (b) the points of origin and destination; (c) the consignor and consignee; and (d) any additional information required by this part.

Permit. An official document issued for and prior to the interstate movement of pseudorabies infected, exposed or vaccinated swine under this part by an Animal and Plant Health Inspection Service representative, State representative, or an accredited veterinarian which states: (a) The number of swine to be moved; (b) the purpose for which the swine are to be moved; (c) the points of origin and destination; (d) the consignor and the consignee; and (e) any additional information required by this part.

Pseudorabies. The contagious, infectious, and communicable disease of livestock and other animals also known as Aujeszky's disease, mad itch, or infectious bulbar paralysis.

Pseudorabies controlled vaccinated herd. (a) Pseudorabies controlled vaccinated herd status is attained by subjecting all swine over 6 months of age to an official pseudorabies serologic test and finding all swine so tested negative. The herd must not have been a known infected herd within the past 30 days. Any swine in the herd over 6 months of age may be vaccinated for pseudorabies within 15 days after being subjected to an official pseudorabies serologic test and found negative.1

(b) If on the qualifying official pseudorabies serologic test or any subsequent official pseudorabies test, any swine so tested are positive, pseudorabies controlled vaccinated herd status is attained or regained by: removing all positive swine; cleaning and disinfecting the herd premises in accordance with §85.13; subjecting all swine in the herd, except swine nursing from their mothers, to an official pseudorabies serologic test 30 days or more after removal of the positive swine and finding all swine so tested negative; and, after an interval of 30 to 60 days after the first such negative official pseudorabies serologic herd test, subjecting all swine in the herd over 6 months of age to another official pseudorabies serologic test and finding all swine so tested negative.

(c)

(1) Pseudorabies controlled vaccinated herd status is maintained by: subjecting 25 percent of all the offspring to an official pseudorabies serologic test when they are between 16 and 20 weeks of age and finding all swine so tested negative, or by leaving 10 percent of the swine over 6 months of age in the herd unvaccinated and subjecting all such unvaccinated swine to an official pseudorabies serologic test every 80-105 days and finding all swine so tested negative.

(2) Any swine in the herd over 6 months of age may be vaccinated for pseudorabies within 15 days after being subjected to an official pseudorabies serologic test and found negative; Provided That, if pseudorabies controlled vaccinated herd status is to be maintained by testing unvaccinated swine over 6 months of age, at least 10 percent of the swine in the herd over 6 months of age shall remain unvaccinated.

(3) All swine intended to be added to a pseudorabies controlled vaccinated herd shall be isolated until the swine have been found negative to an official pseudorabies serologic test conducted 30 days or more after the swine have been placed in isolation. Not more than 90 percent of the swine over 6 months of age added to the herd may be vaccinated for pseudorabies. All additions to the herd which are to be vaccinated for pseudorabies shall be vaccinated within 15 days after being subjected to such official pseudorabies serologic test. All additions to the herd shall be added to the herd within 30 days after such official pseudorabies serologic test.

(4) Swine which have not been vaccinated for pseudorabies and which are to be tested to maintain pseudorabies controlled vaccinated herd status shall be maintained in the herd so that the pseudorabies vaccinates can physically touch nonvaccinates or so that the pseudorabies vaccinates are within 10 feet of nonvaccinates while sharing a direct common ventilation system with such nonvaccinates.

Pseudorabies vaccinate. Any swine that have been vaccinated with any product containing antigens for pseudorabies.

Qualified negative gene-altered vaccinated herd. (a) Any herd in which no swine are known to be infected with or exposed to pseudorabies, and in which no swine are vaccinated for pseudorabies, may achieve status as a qualified negative gene-altered vaccinated herd under the following conditions:

(1) All swine in the herd over 6 months of age must be tested with an official pseudorabies serologic test. For a minimum of 30 days before the test, the herd must not have been a known infected herd. During the 90 days before the test, at least 90 percent of the swine in the herd either must have been on the premises and a part of the herd, or must have entered the herd directly from a qualified pseudorabies negative herd. If any of the tested swine are found positive on this or any other official pseudorabies test prior to vaccination with the official gene-altered pseudorabies vaccine, the requirements in paragraph (a)(2) must be met.

(2) All swine that are positive on an official pseudorabies test must be removed from the herd, or must be isolated until another official pseudorabies test conducted within 30 days of the first test shows them to be negative. If the results of the second test are negative, no additional testing is required before the herd may be vaccinated in accordance with paragraph (a)(3). If the results of the second test are positive, all swine that tested positive must be removed from the herd. Not less than 30 days after any positive swine are removed from the herd, all remaining swine in the herd, except suckling swine, must be tested with an official pseudorabies serologic test and found negative. Not less than 30 days after this negative test, the herd must be tested again in accordance with paragraph (a)(1).

(3) Not more than 30 days after test results show the herd to be negative for pseudorabies in accordance with paragraph (a)(1), all swine in the herd over 6 months of age must be vaccinated with an official gene-altered pseudorabies vaccine. Only one official gene-altered pseudorabies vaccine may be used in the herd.

(b) Any herd designated as a qualified pseudorabies negative herd may achieve new status as a qualified negative gene-altered vaccinated herd if all swine in the herd over 6 months of age are vaccinated with an official gene-altered pseudorabies vaccine. Only one official gene-altered pseudorabies vaccine may be used in the herd.

(c) Any herd in which no swine are known to be infected with or exposed to pseudorabies, and in which the only swine vaccinated for pseudorabies are official gene-altered pseudorabies vaccinates, may achieve status as a qualified negative gene-altered vaccinated herd under the following conditions:

(1) Only one official gene-altered pseudorabies vaccine may be used in the herd.

(2) All swine in the herd over 6 months of age must be tested with an approved differential pseudorabies test. For a minimum of 60 days before the test, the herd must not have been a known infected herd. During the 90 days before the test, at least 90 percent of the swine in the herd either must have been on the premises and a part of the herd or must have entered the herd directly from a qualified pseudorabies negative herd or a qualified negative gene-altered vaccinated herd. If any of the tested swine are found positive on this test, the requirements in paragraph (c)(3) must be met.

(3) All swine positive on an approved differential pseudorabies test must be removed from the herd, or must be isolated until another approved differential pseudorabies test conducted within 30 days of the first test shows them to be negative. If the results of the second test are negative, no additional testing is required before the herd may be vaccinated in accordance with paragraph (c)(4). If the results of the second test are positive, all swine that tested positive must be removed from the herd. No less than 30 days after any negative swine are removed from the herd, all remaining swine in the herd, except suckling swine, must be tested with an approved differential pseudorabies test and found negative. No less than 30 days after this negative test, the herd must be tested again in accordance with paragraph (c)(2).

(4) No more than 30 days after test results show the herd to be negative for pseudorabies in accordance with paragraph (c)(2), all swine in the herd over 6 months of age that are not already official gene-altered pseudorabies vaccinates must be vaccinated with an official gene-altered pseudorabies vaccine. Only one official gene-altered pseudorabies vaccine may be used in the herd.

(d) Qualified negative gene-altered vaccinated herd status is maintained under the following conditions:

(1) All swine over 6 months of age in the herd must be official gene-altered pseudorabies vaccinates, and only one official gene-altered pseudorabies vaccine may be used in the herd.

(2) All swine over 6 months of age in the herd must be tested at least once a year with an approved differential pseudorabies test and found negative; except that, if any swine are positive, the herd may maintain its status if the positive swine are isolated from the rest of the herd until they are found negative to a second approved differential pseudorabies test conducted within 30 days of the first. The requirement for annual testing of all swine in the herd over 6 months of age may be met by testing 25 percent of the swine over 6 months of age every 80-105 days, or by testing 10 percent of the swine over 6 months of age each month. No swine may be tested twice in 1 year to comply with the 25 percent requirement, or twice in 10 months to comply with the 10 percent requirement.

(3) Swine may be added to a qualified negative gene-altered vaccinated herd only under one of the following conditions:

(i) The swine are moved to the qualified negative gene-altered vaccinated herd from another qualified negative gene-altered vaccinated herd, or from a qualified pseudorabies negative herd, without having any contact en route with swine other than those from a qualified negative gene-altered vaccinated herd or a qualified pseudorabies negative herd.

(ii) The swine are moved to the qualified negative gene-altered vaccinated herd from a qualified pseudorabies negative herd, have contact en route with swine other than those from a qualified negative gene-altered vaccinated herd or a qualified pseudorabies negative herd, and, before being added, are isolated until they are found negative to an official pseudorabies serologic test conducted 30 days or more after the swine are isolated.

(iii) The swine are moved to the qualified negative gene-altered vaccinated herd from another qualified negative gene-altered vaccinated herd, have contact en route with swine other than those from a qualified negative gene-altered vaccinated herd or a qualified pseudorabies negative herd, and, before being added, are isolated until they are found negative to an approved differential pseudorabies test conducted 30 days or more after the swine are isolated.

(iv) The swine are removed to the qualified negative gene-altered vaccinated herd from a herd other than a qualified negative gene-altered vaccinated herd or a qualified pseudorabies negative herd, and, before being added, are isolated until they are found negative to two official pseudorabies serologic tests, one conducted at the time the swine are isolated, and the second conducted 30 days or more after the swine are isolated.

Qualified pseudorabies negative herd. (a) Qualified pseudorabies negative herd status is attained by subjecting all swine over 6 months of age to an official pseudorabies serologic test and finding all swine so tested negative. The herd must not have been a known infected herd within the past 30 days. A minimum of 90 percent of the swine in the herd must have been on the premises and a part of the herd for at least 90 days prior to the qualifying official pseudorabies serologic test or have entered directly from another qualified pseudorabies negative herd.

(b)

(1) If on a qualifying official pseudorabies serologic test or any subsequent official pseudorabies test, any swine so tested are positive, qualified pseudorabies negative herd status is attained or regained by: Removing all positive swine and cleaning and disinfecting the herd premises in accordance with §85.13; subjecting all swine in the herd, except swine nursing from their mothers, to an official pseudorabies serologic test 30 days or more after removal of the positive swine and finding all swine so tested negative; and, after an interval of 30 to 60 days after the first such negative official pseudorabies serologic herd test, subjecting all swine in the herd over 6 months of age to another official pseudorabies serologic test and finding all swine so tested negative; or

(2) If on any qualifying official pseudorabies serologic test or any subsequent official pseudorabies serologic test, any swine so tested are positive, but no swine are positive at titers greater than 1:8, qualified pseudorabies negative herd status is attained or regained by: Subjecting all titered swine and all other swine required to be tested by an epidemiologist, approved by the State animal health official and the Veterinarian in Charge, to an official pseudorabies serologic test and finding all such swine negative.1

(c) Qualified pseudorabies negative herd status is maintained by subjecting all swine over 6 months of age in the herd to an official pseudorabies serologic test at least once each year (this must be accomplished by testing 25 percent of swine over 6 months of age every 80-105 days and finding all swine so tested negative, or by testing 10 percent of the swine over 6 months of age each month and finding all swine so tested negative; no swine shall be tested twice in 1 year to comply with the 25 percent requirement or twice in 10 months to comply with the 10 percent requirement). All swine intended to be added to a qualified pseudorabies negative herd shall be isolated until the swine have been found negative to two official pseudorabies serologic tests, one conducted 30 days or more after the swine have been placed in isolation, the second test being conducted 30 days or more after the first test; except (1) swine intended to be added to a qualified pseudorabies negative herd directly from another qualified pseudorabies negative herd may be added without isolation or testing; (2) swine intended to be added to a qualified pseudorabies negative herd from another qualified pseudorabies negative herd, but with interim contact with swine other than those from a single qualified pseudorabies negative herd, shall be isolated until the swine have been found negative to an official pseudorabies serologic test, conducted 30 days or more after the swine have been placed in isolation; (3) swine returned to the herd after contact with swine other than those from a single qualified pseudorabies negative herd shall be isolated until the swine have been found negative to an official pseudorabies serologic test conducted 30 days or more after the swine have been placed in isolation.

Quarantined feedlot. A premises where pseudorabies infected or exposed swine are fed under the supervision and control of the State animal health official, and from which such swine are moved directly to a recognized slaughtering establishment or directly through one or more slaughter markets and then directly to a recognized slaughtering establishment in accordance with the provisions of this part.

Quarantined herd. A herd in which pseudorabies infected or exposed swine are bred, reared, and fed under the supervision and control of the State animal health official, and from which such swine are moved interstate directly to a recognized slaughtering establishment or directly through one or more slaughter markets and then directly to a recognized slaughtering establishment, or from which exposed officially vaccinated swine which were negative to an official pseudorabies serologic test may be moved only to a quarantined herd or quarantined feedlot.

Recognized slaughtering establishment. A slaughtering establishment operated under the provisions of the Federal Meat Inspection Act (21 U.S.C. 601 et seq.) or a State inspected slaughtering establishment.

Slaughter market. A livestock market approved in accordance with §71.20 of this chapter, at which swine for sale and shipment for slaughter are handled only on days when no swine are handled for sale and shipment for feeding or breeding purposes unless facilities are provided to keep slaughter swine physically separated from feeder and breeder swine, and feeder and breeder swine use no facilities previously used by slaughter swine on the day these classes of swine are at the market. The facilities used by slaughter swine shall be cleaned and disinfected in accordance with the requirements of this part before being used for feeding or breeding swine.9 10

State. Any State or Territory of the United States, the District of Columbia, Puerto Rico, Guam or the Northern Mariana Islands.

State animal health official. The State animal health official who is responsible for the livestock and poultry disease control and eradication programs in the official's State or his designated representative.

State representative. A person regularly employed in animal health work of a State and who is authorized by such State to perform the function involved under a Cooperative Agreement with the United States Department of Agriculture.

Swine not known to be infected with or exposed to pseudorabies. Any swine from a herd of swine in which no animal has been classified as a reactor to an official pseudorabies test, or has been diagnosed as having pseudorabies or suspected of having pseudorabies by a veterinarian; or any swine from a herd of swine which has been released from quarantine or has met the requirements of release from quarantine in accordance with the definition of known infected herd in §85.1.

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

Veterinary Services. Veterinary Services, Animal and Plant Health Inspection Service, United States Department of Agriculture.

Veterinary Services representative. A person employed by Veterinary Services, Animal and Plant Health Inspection Service, United States Department of Agriculture, who is authorized to perform the function involved.

(Approved by the Office of Management and Budget under control number 0579-0069)

[44 FR 10309, Feb. 16, 1979]