§ 145.43 Terminology and classification; flocks and products. Participating flocks, and the eggs and poults produced from them, which have met the respective requirements specified in this section may be designated by the following terms and the corresponding designs illustrated in § 145.10: ( a ) [Reserved]
( b ) *U.S. Pullorum-Typhoid Clean.* A flock in which freedom from pullorum and typhoid has been demonstrated to the official State agency under the criteria in one of the following paragraphs (b)(1) through (5) of this section: *Provided,* That a flock qualifying by means of a blood test shall be tested within the past 12 months, except that the retesting of a participating flock which is retained for more than 12 months shall be conducted a minimum of 4 weeks after the induction of molt. (See § 145.14 relating to the official blood test where applicable.) ( 1 ) It has been officially blood tested with either no reactors or reactors that, upon further bacteriological examination conducted in accordance with part 147 of this subchapter, fail to isolate *S. pullorum* or *S. gallinarum.*
( 2 ) It is a multiplier breeding flock, or a breeding flock composed of progeny of a primary breeding flock which is intended solely for the production of multiplier breeding flocks, and meets the following specifications as determined by the Official State Agency and the Service: ( i ) The flock is located in a State where all persons performing poultry disease diagnostic services within the State are required to report to the Official State Agency within 48 hours the source of all poultry specimens from which S. pullorum or S. gallinarum is isolated;
( ii ) The flock is composed entirely of birds that originated from U.S. Pullorum-Typhoid Clean breeding flocks or from flocks that met equivalent requirements under official supervision; and
( iii ) The flock is located on a premises where a flock not classified as U.S. Pullorum-Typhoid Clean was located the previous year; *Provided,* That an Authorized Testing Agent must blood test up to 300 birds per flock, as described in § 145.14, if the Official State Agency determines that the flock has been exposed to pullorum-typhoid. In making determinations of exposure and setting the number of birds to be blood tested, the Official State Agency shall evaluate the results of any blood tests, described in § 145.14(a)(1), that were performed on an unclassified flock located on the premises during the previous year; the origins of the unclassified flock; and the probability of contacts between the flock for which qualification is being sought and (a) infected wild birds, (b) contaminated feed or waste, or (c) birds, equipment, supplies, or personnel from flocks infected with pullorum-typhoid.
( 3 ) It is a multiplier breeding flock, or a breeding flock composed of progeny of a primary breeding flock which is intended solely for the production of multiplier breeding flocks, that originated from U.S. Pullorum-Typhoid Clean breeding flocks or from flocks that met equivalent requirements under official supervision, and is located in a State in which it has been determined by the Service that: ( i ) All turkey hatcheries within the State are qualified as “National Plan Hatcheries” or have met equivalent requirements for pullorum-typhoid control under official supervision;
( ii ) All turkey hatchery supply flocks within the State are qualified as U.S. Pullorum-Typhoid Clean or have met equivalent requirements for pullorum-typhoid control under official supervision: *Provided,* That if other domesticated fowl, except waterfowl, are maintained on the same premises as the participating flock, freedom from pullorum-typhoid infection shall be demonstrated by an official blood test of each of these fowl;
( iii ) All shipments of products other than U.S. Pullorum-Typhoid Clean, or equivalent, into the State are prohibited;
( iv ) All persons performing poultry disease diagnostic services within the State are required to report to the Official State Agency within 48 hours the source of all poultry specimens from which S. pullorum or S. gallinarum is isolated;
( v ) All reports of any disease outbreak involving a disease covered under the Plan are promptly followed by an investigation by the Official State Agency to determine the origin of the infection; *Provided,* That if the origin of the infection involves another State, or if there is exposure to poultry in another State from the infected flock, then the National Poultry Improvement Plan will conduct an investigation;
( vi ) All flocks found to be infected with pullorum or typhoid are quarantined until marketed or destroyed under the supervision of the Official State Agency, or until subsequently blood tested, following the procedure for reacting flocks as contained in § 145.14(a)(5), and all birds fail to demonstrate pullorum or typhoid infection;
( vii ) [Reserved]
( viii ) Discontinuation of any of the conditions or procedures described in paragraphs (b)(3)(i), (ii), (iii), (iv), (v), and (vi) of this section, or the occurrence of repeated outbreaks of pullorum or typhoid in turkey breeding flocks within or originating within the State shall be grounds for the Service to revoke its determination that such conditions and procedures have been met or complied with. Such action shall not be taken until a thorough investigation has been made by the Service and the Official State Agency has been given an opportunity to present its views.
( 4 ) It is a multiplier breeding flock located in a State which has been determined by the Service to be in compliance with the provisions of paragraph (b)(3) of this section and in which pullorum disease or fowl typhoid is not known to exist nor to have existed in turkey hatchery supply flocks within the State during the preceding 24 months.
( 5 ) It is a primary breeding flock located in a State determined to be in compliance with the provisions of paragraph (b)(4) of this section and in which a sample of 300 birds from flocks of more than 300, and each bird in flocks of 300 or less, has been officially tested for pullorum-typhoid with either no reactors or reactors that, upon further bacteriological examination conducted in accordance with part 147 of this subchapter, fail to isolate *S. pullorum* or *S. gallinarum: Provided,* That a bacteriological examination monitoring program acceptable to the Official State Agency and approved by APHIS may be used in lieu of blood testing.
( c ) *U.S. M. Gallisepticum Clean.* ( 1 ) A flock maintained in accordance with part 147 of this subchapter with respect to Mycoplasma isolation, sanitation, and management, and in which no reactors are found when a random sample of at least 10 percent of the birds in the flock, or 300 birds in flocks of more than 300 and each bird in flocks of 300 or less, is tested when more than 12 weeks of age, in accordance with the procedures described in § 145.14(b): *Provided,* That to retain this classification, a minimum of 30 samples from male flocks and 60 samples from female flocks shall be retested at 28-30 weeks of age and at 4-6 week intervals thereafter.
( 2 ) A flock qualified as U.S. M. Gallisepticum Clean may retain the classification through its first egg-laying cycle, provided it is maintained in isolation and no evidence of *M. gallisepticum* infection is revealed. A flock which is molted following completion of an egg-laying cycle and subsequently brought back into production, shall be retested within 2 weeks prior to production, as described in paragraph (c)(1) of this section. A State inspector shall visit with the owner or manager of each flock at least once during each laying cycle to discuss and ascertain whether the flock is being maintained in accordance with part 147 of this subchapter with respect to Mycoplasma isolation, sanitation, and management. If a flock proves to be infected with *M. gallisepticum,* it shall lose this classification.
( 3 ) In order to sell hatching eggs or poults of this classification, all hatching eggs and poults handled by the participant must be of this classification.
( d ) *U.S. M. Meleagridis Clean.* ( 1 ) A flock in which freedom from *M. meleagridis* has been demonstrated under the following criteria: ( i ) A sample of 100 birds from each flock has been tested for *M. meleagridis* when more than 12 weeks of age: *Provided,* That to retain this classification, a minimum of 30 samples from male flocks and 60 samples from female flocks shall be retested at 28-30 weeks of age and at 4-6 week intervals thereafter.
( 2 ) - ( 3 ) [Reserved]
( 4 ) When reactors to the official test are found and can be identified, 10 tracheal swabs and/or vaginal or phallus swabs and their corresponding blood samples shall be submitted to a laboratory for serological and cultural examination. If reactors cannot be identified, at least 30 tracheal swabs and/or vaginal or phallus swabs and their corresponding blood samples shall be submitted. In a flock with a low reactor rate (less than 5 reactors) the reactors may be submitted to the laboratory within 10 days for serology, necropsy, and thorough bacteriological examination.
( 5 ) If a mycoplasma is isolated, the organism must be serotyped. If *M. meleagridis* is isolated, the block shall be considered infected.
( e ) *U.S. M. Synoviae Clean.* ( 1 ) All birds, or a sample of at least 100 birds from flocks of more than 100 and each bird in flocks of 100 or less, have been tested for *M. synoviae* when more than 12 weeks of age in accordance with the procedures in § 145.14(b): *Provided,* That to retain this classification a minimum of 30 samples from male flocks and 60 samples from female flocks shall be retested at 28-30 weeks of age and at 4-6 week intervals thereafter. It is recommended that any birds that are showing clinical signs of *M. synoviae* infection be included in samples taken.
( 2 ) When reactors to the official test are found and can be identified, tracheal swabs and their corresponding blood samples from 10 (all if fewer than 10) reacting birds shall be submitted to an authorized laboratory for serological and cultural examination. If reactors cannot be identified, at least 30 tracheal swabs and their corresponding blood samples shall be submitted. In a flock with a low reactor rate (less than five reactors) the reactors may be submitted to the laboratory within 10 days for serology, necropsy, and thorough bacteriological examination. When reactors to the official test are found, the procedures outlined in part 147 of this subchapter will be used to determine the status of the flock.
( f ) *U.S. Sanitation Monitored, Turkeys.* A flock or hatchery whose owner is controlling or reducing the level of salmonella through compliance with sanitation and management practices in accordance with part 147 of this subchapter, and where the following monitoring, testing, and management practices are conducted: ( 1 ) Hatchery debris (dead germ hatching eggs, fluff, and meconium collected by sexors), swabs collected from hatch debris in hatcher trays, a sample of all the poults that died within 10 days after hatching up to 10 poults, or a combination of 2 or all 3 of the above, from each hatch or a candidate breeding flock produced by a primary breeder, are examined bacteriologically at an authorized laboratory for *Salmonella.*
( 2 ) The poults for the candidate breeding flock are placed in a building that has been cleaned and disinfected. An Authorized Agent must collect environmental samples from the building and submit them to an authorized laboratory for a bacteriological examination for the presence of *Salmonella,* in accordance with part 147 of this subchapter.
( 3 ) Feed for turkeys in the candidate and breeding flock should meet the following requirements: ( i ) All feed manufactured in pellet form must have a maximum moisture content of 13.5 percent upon delivery to the farm. It should have been preconditioned to the minimum of one of the following parameters before pelleting: ( A ) Feed is to reach a minimum temperature of 185 °F for a minimum of 6 minutes of retention in the conditioning chamber. The conditioned mash feed moisture must be a minimum of 16 percent during the conditioning process. This method utilizes time retention to allow permeation to the center core of each feed particle; or
( B ) The feed is to be pressurized in order to expedite the transfer of the heat and moisture to the core of each feed particle. The feed should be conditioned to the parameters of a minimum of 16 percent moisture and 200 °F; or
( C ) The feed should be submitted to pressurization to the extent that the initial feed temperature rises to 235 °F for 4 seconds; or
( D ) The feed should be submitted to an equivalent thermal lethality treatment; or
( E ) A Food and Drug Administration (FDA)-approved product for *Salmonella* control should be added to the finished pellets.
( ii ) Mash feed should be treated with an FDA-approved *Salmonella* control product.
( iii ) All feed is to be stored and transported in such a manner as to prevent possible contamination with pathogenic bacteria.
( iv ) FDA-approved products for *Salmonella* control may be added to either unfinished or finished feed.
( 4 ) Environmental samples shall be taken by an Authorized Agent, in accordance with part 147 of this subchapter, from each flock at 12-20 weeks of age and examined bacteriologically at an authorized laboratory for Salmonella.
( 5 ) Owners of flocks found infected with a paratyphoid Salmonella may vaccinate these flocks with an autogenous bacterin with a potentiating agent.[5]
( 6 ) Environmental samples shall be taken by an Authorized Agent, in accordance with part 147 of this subchapter, from each flock at 35-50 weeks of age and from each molted flock at midlay, and examined bacteriologically at an authorized laboratory for Salmonella.
( 7 ) Hatchery debris (dead germ hatching eggs, fluff, and meconium collected by sexors), swabs collected from hatch debris in hatcher trays, a sample of all the poults that died within 10 days after hatching up to 10 poults, or a combination of 2 or all 3 of the above, shall be cultured as a means of evaluating the effectiveness of the control procedures.
( g ) *U.S. H5/H7 Avian Influenza Clean.* This program is intended to be the basis from which the turkey breeding industry may conduct a program for the prevention and control of the H5/H7 subtypes of avian influenza. It is intended to determine the presence of the H5/H7 subtypes of avian influenza in breeding turkeys through routine surveillance of each participating breeding flock. A flock, and the hatching eggs and poults produced from it, will qualify for this classification when the Official State Agency determines that it has met one of the following requirements: ( 1 ) It is a primary breeding flock in which a minimum of 30 birds have been tested negative to the H5/H7 subtypes of avian influenza as provided in § 145.14(d) when more than 4 months of age and prior to the onset of egg production. To retain this classification: ( i ) A sample of at least 30 birds must be tested negative at intervals of 90 days; or
( ii ) A sample of fewer than 30 birds may be tested, and found to be negative, at any one time if all pens are equally represented and a total of 30 birds are tested within each 90-day period.
( 2 ) It is a multiplier breeding flock in which a minimum of 30 birds have been tested negative for antibodies for avian influenza to the H5/H7 subtypes of avian influenza as provided in § 145.14(d) when more than 4 months of age and prior to the onset of egg production. To retain this classification: ( i ) A sample of at least 30 birds must be tested negative at intervals of 90 days; or
( ii ) A sample of fewer than 30 birds may be tested, and found to be negative, at any one time if all pens are equally represented and a total of 30 birds are tested within each 90-day period.
( 3 ) All spent fowl being marketed for meat from flocks that have been tested as required by this paragraph shall be tested at a rate of 6 birds per flock within 21 days prior to movement to slaughter.
( 4 ) For both primary and multiplier breeding flocks, if a killed influenza vaccine against avian influenza subtypes other than H5 and H7 is used, then the hemagglutinin and the neuraminidase subtypes of the vaccine must be reported to the Official State Agency for laboratory and reporting purposes.
( h ) *U.S. Newcastle Disease Clean.* The program in this paragraph (h) is intended to be the basis from which the breeding-hatchery industry may conduct a program for the prevention and control of Newcastle disease. It is intended to determine the presence of Newcastle disease in primary breeding turkeys through vaccination and/or monitoring of each participating breeding flock. A flock and the hatching eggs and poults produced from it will qualify for classification in this paragraph (h) when the Official State Agency determines that they have met the following requirements: ( 1 ) It is a primary breeding flock that is either: ( i ) Vaccinated for Newcastle disease using USDA-licensed vaccines and response to vaccination is serologically monitored using an approved test as described in § 145.14 when more than 4 months of age, and meets the criteria in paragraph (h)(2) of this section to retain classification; or
( ii ) Unvaccinated for Newcastle disease, in which a minimum of 30 birds have tested negative to ND using an approved test as described in § 145.14 when more than 4 months of age and meets criteria in paragraph (h)(3) of this section to retain classification.
( 2 ) To retain the classification in this paragraph (h) for vaccinated flocks: ( i ) Vaccines for ND must be USDA-licensed vaccines administered during early stages of development through rearing, and inactivated vaccines as final vaccination prior to the onset of egg production; and
( ii ) The flock has been monitored for antibody response using approved serological tests as listed in § 145.14 and the results are compatible with immunological response against ND vaccination; and
( iii ) Testing must include a minimum of 30 birds with a serologic monitoring program when more than 4 months of age and prior to the onset of production and not longer than every 90 days thereafter.
( 3 ) To retain the classification in this paragraph (h) for unvaccinated flocks: ( i ) A minimum of 30 birds per flock must test negative using an approved test in § 145.14 at intervals of 90 days; or
( ii ) A sample of fewer than 30 birds may be tested, and found negative, at any one time if all pens are equally represented and a total of 30 birds is tested within each 90-day period; and
( iii ) During each 90-day period, all primary spent fowl, up to a maximum of 30, must test negative to ND within 21 days prior to movement to slaughter.
( 4 ) Newcastle disease must be a disease reportable to the responsible State authority (State veterinarian, etc.) by all licensed veterinarians. To accomplish this, all laboratories (private, State, and university laboratories) that perform diagnostic procedures on poultry must examine all submitted cases of unexplained respiratory disease, egg production drops, and mortality for ND.
(Approved by the Office of Management and Budget under control numbers 0579-0007 and 0579-0474) [36 FR 23112, Dec. 3, 1971] Editorial Note
Editorial Note: For Federal Register citations affecting § 145.43, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at *www.govinfo.gov .*
Footnotes -
145.43
[5] Preparation and use of this type of vaccine may be regulated by state statutes.