§ 145.83 Terminology and classification; flocks and products. Participating flocks, and the eggs and chicks 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 paragraph (b)(1) or (b)(2) 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 primary breeding flock that meets the following criteria: ( i ) The primary breeding flock is located in a State in which pullorum disease or fowl typhoid is not known to exist nor to have existed in hatchery supply flocks within the State during the preceding 12 months and in which it has been determined by the Service that: ( A ) All hatcheries within the State are qualified as “National Plan Hatcheries” or have met equivalent requirements for pullorum-typhoid control under official supervision;
( B ) All 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;
( C ) All shipments of products other than U.S. Pullorum-Typhoid Clean, or equivalent, into the State are prohibited;
( D ) 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;
( E ) 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 officials administering the National Poultry Improvement Plan will conduct an investigation;
( F ) 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) of this subchapter, and all birds fail to demonstrate pullorum or typhoid infection;
( G ) All poultry, including exhibition, exotic, and game birds, but excluding waterfowl, going to public exhibition shall come from U.S. Pullorum-Typhoid Clean or equivalent flocks, or have had a negative pullorum-typhoid test within 90 days of going to public exhibition; and
( H ) Discontinuation of any of the conditions or procedures described in paragraphs (b)(2)(i)(A) through (b)(2)(i)(G) of this section, or the occurrence of repeated outbreaks of pullorum or typhoid in poultry 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; and
( ii ) In the primary breeding flock, 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 freedom from *M. gallisepticum* has been demonstrated under the criteria specified in paragraph (c)(1)(i) of this section. ( i ) It is a flock in which all birds or a sample of at least 300 birds has been tested for *M. gallisepticum* as provided in § 145.14(b) of this subchapter when more than 4 months of age: *Provided,* That to retain this classification, a minimum of 40 birds shall be tested at intervals of not more than 28 days, and a total of at least 150 birds shall be tested within each 90-day period.
( ii ) [Reserved]
( 2 ) A participant handling U.S. M. Gallisepticum Clean products must handle only products of equivalent status.
( 3 ) U.S. M. Gallisepticum Clean chicks shall be boxed in clean boxes and delivered in trucks that have been cleaned and disinfected in accordance with part 147 of this subchapter.
( d ) *U.S. M. Synoviae Clean.* ( 1 ) A flock maintained in accordance with part 147 of this subchapter with respect to Mycoplasma isolation, sanitation, and management and in which freedom from *M. synoviae* has been demonstrated under the criteria specified in paragraph (d)(1)(i) of this section. ( i ) It is a flock in which all birds or a sample of at least 300 birds has been tested for *M. synoviae* as provided in § 145.14(b) of this subchapter when more than 4 months of age: *Provided,* That to retain this classification, a sample of at least 40 birds shall be tested at intervals of not more than 28 days, and a total of at least 150 birds shall be tested within each 90-day period.
( ii ) [Reserved]
( 2 ) A participant handling U.S. M. Synoviae Clean products shall handle only products of equivalent status.
( 3 ) U.S. M. Synoviae Clean chicks shall be boxed in clean boxes and delivered in trucks that have been cleaned and disinfected in accordance with part 147 of this subchapter.
( e ) *U.S. S. Enteritidis Clean.* This classification is intended for primary meat-type breeders wishing to assure their customers that the chicks produced are certified free of *Salmonella enteritidis.* ( 1 ) A flock and the hatching eggs and chicks produced from it shall be eligible for this classification if they meet the following requirements, as determined by the Official State Agency: ( i ) The flock originated from a U.S. S. Enteritidis Clean flock, or one of the following samples has been examined bacteriologically for *S. enteritidis* at an authorized laboratory in accordance with part 147 of this subchapter and any group D Salmonella samples have been serotyped: ( A ) A sample of chick papers, hatcher tray swabs, or fluff collected and cultured in accordance with part 147 of this subchapter; and
( B ) Samples of intestinal and liver or spleen tissues from a minimum of 30 chicks that died within 7 days after hatching and have been preserved daily by freezing prior to shipment to an authorized laboratory.
( ii ) The flock is maintained in compliance with isolation, sanitation, and management procedures for Salmonella in accordance with part 147 of this subchapter.
( iii ) Environmental samples are collected from the flock by or under the supervision of an Authorized Agent, in accordance with part 147 of this subchapter, when the flock reaches 4 months of age and every 30 days thereafter. Once the flock is in egg production and chicks are hatching from it, the samples must include at least 4 individual test assay results every 30 days in flocks of more than 500 birds or 2 individual assays per month in flocks of 500 birds or fewer. One of these results must come from samples collected from hatched chicks at a participating hatchery derived from said flock. These individual test assays may be derived from pooled samples from the farm or hatchery in accordance with part 147 of this subchapter, but must be run as separate test assays in the laboratory. The environmental samples shall be examined bacteriologically for group D Salmonella at an authorized laboratory, and cultures from group D positive samples shall be serotyped.
( iv ) Hatching eggs produced by the flock are collected as quickly as possible and their sanitation is maintained in accordance with part 147 of this subchapter.
( v ) Hatching eggs produced by the flock are incubated in a hatchery whose sanitation is maintained in accordance with part 147 of this subchapter, and the hatchery must have been sanitized either by a procedure approved by the Official State Agency or by fumigation in accordance with part 147 of this subchapter.
( 2 ) If *Salmonella enteritidis* serotype *enteritidis* (SE) is isolated from a specimen taken from a bird in the flock, except as provided in paragraph (e)(3) of this section, the flock shall not be eligible for this classification.
( 3 ) If SE is isolated from an environmental sample collected from the flock in accordance with paragraph (e)(1)(iii) of this section, an additional environmental sampling and 25 live cull birds or fresh dead birds (if present), or other randomly selected live birds if fewer than 25 culls can be found in the flock, must be bacteriologically examined for SE in accordance with part 147 of this subchapter. If only 1 bird from the 25-bird sample is found positive for SE., the participant may request bacteriological examination of a second 25-bird sample from the flock. In addition, if the flock with the SE isolation is in egg production and eggs are under incubation, the next four consecutive hatches shall be examined bacteriologically in accordance with part 147 of this subchapter. Samples shall be collected from all of the hatching unit's chick trays and basket trays of hatching eggs, or from all chick box papers from the flock, and tested, pooling the samples into a minimum of 10 separate assays. Any followup hatchery-positive SE isolations shall result in discontinuation of subsequent hatches until the flock status is determined by bird culture. The flock will be disqualified for the U.S. S. Enteritidis Clean classification if a bird or subsequent flock environmental assay results in isolation of SE.
( 4 ) In order for a hatchery to sell products of this classification, all products handled by the hatchery must meet the requirements of this paragraph.
( 5 ) This classification may be revoked by the Official State Agency if the participant fails to follow recommended corrective measures. The Official State Agency shall not revoke the participant's classification until the participant has been given an opportunity for a hearing in accordance with rules of practice adopted by the Official State Agency.
( 6 ) A pedigree, experimental, great-grandparent, or grandparent flock that is removed from the U.S. S. Enteritidis Clean program may be reinstated whenever the following conditions are met: ( i ) The owner attests that corrective measures have been implemented, which may include one or more of the following: ( A ) Test and slaughter infected birds based on blood tests of every bird in the flock, with either pullorum antigen or by a federally licensed *Salmonella enteritidis* enzyme-linked immunosorbent assay (ELISA) test when the flock is more than 4 months of age.
( B ) Perform other corrective actions including, but not limited to, vaccination, medication, cleaning and disinfection of houses, rodent control, and movement of uninfected birds to premises that have been determined to be environmentally negative for *S. enteritidis* in accordance with par 147 of this subchapter.
( C ) One hundred percent of blood samples from the birds moved to the clean premises are tested negative for *Salmonella pullorum* and group D *Salmonella.* All birds with positive or inconclusive reactions, up to a maximum of 25 birds, shall be submitted to an authorized laboratory and examined for the presence of group D *Salmonella,* in accordance with part 147 of this subchapter. Cultures from positive samples shall be serotyped.
( D ) Two consecutive environmental drag swabs taken at the clean premises collected in accordance with part 147 of this subchapter 4 weeks apart are negative for *S. enteritidis.*
( E ) Other corrective measures at the discretion of the Official State Agency.
( ii ) Following reinstatement, a flock will remain eligible for this classification if the flock is tested in accordance with paragraph (e)(1)(v) of this section every 30 days and no positive samples are found and the flock meets the requirements set forth in § 145.83(e).
( f ) *U.S. Salmonella Monitored.* This program is intended to be the basis from which the breeding-hatching industry may conduct a program for the prevention and control of salmonellosis. It is intended to reduce the incidence of *Salmonella* organisms in hatching eggs and chicks through an effective and practical sanitation program at the breeder farm and in the hatchery. This will afford other segments of the poultry industry an opportunity to reduce the incidence of *Salmonella* in their products. ( 1 ) A flock and the hatching eggs and chicks produced from it that have met the following requirements, as determined by the Official State Agency. ( i ) Measures shall be implemented to control *Salmonella* challenge through feed, feed storage, and feed transport.
( ii ) Chicks shall be hatched in a hatchery whose sanitation is maintained in accordance with part 147 of this subchapter and sanitized or fumigated in accordance with part 147 of this subchapter.
( iii ) An Authorized Agent shall take environmental samples from the hatchery every 30 days; *i.e.*, meconium or chick papers. An authorized laboratory for *Salmonella* shall examine the samples bacteriologically;
( iv ) An Authorized Agent shall take environmental samples in accordance with part 147 of this subchapter from each flock at 4 months of age and every 30 days thereafter. An authorized laboratory for *Salmonella* shall examine the environmental samples bacteriologically. All *Salmonella* isolates from a flock shall be serogrouped and shall be reported to the Official State Agency on a monthly basis;
( v ) Owners of flocks may vaccinate with a paratyphoid vaccine: *Provided,* That a sample of 350 birds, which will be banded for identification, shall remain unvaccinated until the flock reaches at least 4 months of age to allow for the serological testing required under paragraph (f)(1)(iv) of this section.
( vi ) Any flock entering the production period that is in compliance with all the requirements of § 145.83(f) with no history of *Salmonella* isolations shall be considered “*Salmonella* negative” and may retain this definition as long as no environmental or bird *Salmonella* isolations are identified and confirmed from the flock or flock environment by sampling on 4 separate collection dates over a minimum of a 2-week period. Sampling and testing must be performed as described in paragraph (f)(1)(iv) of this section. An unconfirmed environmental *Salmonella* isolation shall not change this *Salmonella* negative status.
( 2 ) The Official State Agency may monitor the effectiveness of the sanitation practices in accordance with part 147 of this subchapter.
( 3 ) In order for a hatchery to sell products of paragraphs (f)(1)(i) through (f)(1)(vi) of this section, all products handled shall meet the requirements of the classification.
( 4 ) This classification may be revoked by the Official State Agency if the participant fails to follow recommended corrective measures.
( g ) *U.S. Avian Influenza Clean.* This program is intended to be the basis from which the breeding-hatchery industry may conduct a program for the prevention and control of avian influenza. It is intended to determine the presence of avian influenza in primary breeding chickens through routine surveillance of each participating breeding flock. A flock and the hatching eggs and chicks produced from it will qualify for this classification when the Official State Agency determines that they have met the following requirements: ( 1 ) It is a primary breeding flock in which a minimum of 30 birds have been tested negative for antibodies to avian influenza using an approved test as described in § 145.14 when more than 4 months of age. 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 is tested within each 90-day period; or
( iii ) The flock is tested as provided in § 145.14(d) at intervals of 30 days or less and found to be negative, and a total of 30 samples are collected and tested within each 90-day period; and
( 2 ) During each 90-day period, all primary spent fowl, up to a maximum of 30, must be tested serologically and found negative for antibodies for avian influenza within 21 days prior to movement to slaughter.
( h ) *U.S. Newcastle Disease (ND) 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 chickens through vaccination and/or monitoring of each participating breeding flock. A flock and the hatching eggs and chicks produced from it will qualify for the 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 described 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 as described 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 number 0579-0474) [72 FR 1422, Jan. 12, 2007, as amended at 76 FR 15794, Mar. 22, 2011; 79 FR 38762, July 9, 2014; 79 FR 71624, Dec. 3, 2014; 81 FR 53250, Aug. 12, 2016; 83 FR 28354, June 19, 2018; 85 FR 62568, Oct. 5, 2020]