9 CFR Part 145 — National Poultry Improvement Plan for Breeding Poultry

PART 145—NATIONAL POULTRY IMPROVEMENT PLAN FOR BREEDING POULTRY Authority: 7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4. Source: 36 FR 23112, Dec. 3, 1971, unless otherwise noted. Redesignated at 44 FR 61586, Oct. 26, 1979. Editorial Note: Nomenclature changes to part 145 appear at 90 FR 46745, Sept. 30, 2025. Subpart A—General Provisions § 145.1 Definitions. Words used in this part in the singular form shall be deemed to import the plural, and vice versa, as the case may demand. Except where the context otherwise requires, for the purposes of this part the following terms shall be construed, respectively, to mean: Administrator. Affiliated flockowner. Animal and Plant Health Inspection Service. Authorized agent. Authorized laboratory. Authorized testing agent. Avian influenza. Baby poultry. Colon bacilli. Dealer. Department. Domesticated. Equivalent or equivalent requirements. Exposed (Exposure). Flock As applied to breeding. (2) As applied to disease control. Fluff sample. Fowl typhoid or typhoid. Salmonella enterica enterica Salmonella Franchise breeder. Franchise hatchery. H5/H7 low pathogenic avian influenza (LPAI). Hatchery. Independent flock. Infected flock. Midlay. Multiplier breeding flock. Newcastle disease. (1) The virus has an intracerebral pathogenicity index (ICPI) in day-old chicks (Gallusgallus) of 0.7 or greater; or (2) 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. Failure to demonstrate the characteristic pattern of amino acid residues as described in the preceding sentences would require characterization of the isolated virus by an ICPI test. NPIP Program Standards. http://www.poultryimprovement.org/ NPIP Technical Committee. Official State Agency. Official supervision As applied to Plan programs. (2) As applied to non-Plan but equivalent State poultry improvement programs. Person. Plan. Poultry. Primary breeding flock. Products. Program. Public exhibition. Pullorum disease or pullorum. Salmonella enterica enterica Salmonella Reactor. Salmonella. Salmonella Enteritidis. Salmonella enterica enterica Sanitize. Senior Coordinator. (1) Serving as executive secretary of the General Conference Committee; (2) Serving as chairperson of the Plan Conference described in § 147.47; (3) Planning, organizing, and conducting the Plan Conference; (4) Reviewing NPIP authorized laboratories as described in § 147.52; (5) Coordinating the State administration of the NPIP through periodic reviews of the administrative procedures of the Official State Agencies, according to the applicable provisions of the Plan and the Memorandum of Understanding; (6) Coordinating rulemaking to incorporate the proposed changes of the provisions approved at the Plan conference into the regulations in parts 145, 146, and 147 of this subchapter; (7) Directing the production of official NPIP publications; (8) Proposing an annual budget for plan activities and the General Conference Committee; and (9) Providing overall administration of the NPIP. Service. Serial. Sexual maturity. Started poultry. State. State Inspector. Stock. Strain. Succeeding flock. Suspect flock. Trade name or number. [36 FR 23112, Dec. 3, 1971. Redesignated at 44 FR 61586, Oct. 26, 1979] Editorial Note: For Federal Register www.govinfo.gov. § 145.2 Administration. (a) The Department cooperates through a Memorandum of Understanding with Official State Agencies in the administration of the Plan. In the Memorandum of Understanding, the Official State Agency must designate a contact representative to serve as a liaison between the Service and the Official State Agency. (b) The administrative procedures and decisions of the Official State Agency are subject to review by the Service. The Official State Agency shall carry out the administration of the Plan within the State according to the applicable provisions of the Plan and the Memorandum of Understanding. (c) An Official State Agency may accept for participation an affiliated flock located in another State under a mutual understanding and agreement, in writing, between the two Official State Agencies regarding conditions of participation and supervision. (d) The Official State Agency of any State may, except as limited by § 145.3(f), adopt regulations applicable to the administration of the Plan in such State further defining the provisions of the Plan or establishing higher standards compatible with the Plan. (e) An authorized laboratory of the National Poultry Improvement Plan will conduct tests in accordance with part 147 of this subchapter when determining the status of a participating flock with respect to an official Plan classification. (Approved by the Office of Management and Budget under control number 0579-0007) [36 FR 23112, Dec. 3, 1971. Redesignated at 44 FR 61586, Oct. 26, 1979, and amended at 48 FR 57473, Dec. 30, 1983; 67 FR 8468, Feb. 25, 2002; 74 FR 14714, Apr. 1, 2009; 79 FR 38754, July 9, 2014; 81 FR 53249, Aug. 12, 2016; 90 FR 46745, Sept. 30, 2025] § 145.3 Participation. (a) The National Poultry Improvement Plan is a cooperative Federal-State-Industry program through which new or existing diagnostic technology can be effectively applied to improve poultry and poultry products by controlling or eliminating specific poultry diseases. The Plan consists of programs that identify States, flocks, hatcheries, dealers, and slaughter plants that meet specific disease control standards specified in the Plan. Participants shall maintain records to demonstrate that they adhere to the disease control programs in which they participate. (b) Any person producing or dealing in products may participate in the Plan when he has demonstrated, to the satisfaction of the Official State Agency, that his facilities, personnel, and practices are adequate for carrying out the applicable provisions of the Plan, and has signed an agreement with the Official State Agency to comply with the general and the applicable specific provisions of the Plan and any regulations of the Official State Agency under § 145.2. Affiliated flockowners may participate without signing an agreement with the Official State Agency. (c) Each participant shall comply with the Plan throughout the operating year of the Official State Agency, or until released by such Agency. (d) A participant in any State shall participate with all of his poultry hatching egg supply flocks and hatchery operations within such State. The participant shall report to the Official State Agency on VS Form 9-2 (formerly NPIP Form 3B) or through other appropriate means each breeding flock before the birds reach 24 weeks of age or, in the case of ostriches, emus, rheas, and cassowaries, before the birds reach 20 months of age. This report will include: (1) Name and address of flockowner; (2) Flock location and designation; (3) Type: Primary or Multiplier; (4) Breed, variety, strain, or trade name of stock; (5) Source of males; (6) Source of females; (7) Number of birds in the flock; and (8) Intended classification of flock. (e) To ensure that Plan diseases are not spread, flocks must be qualified for their intended Plan classifications before being moved into breeder production facilities. (f) No person shall be compelled by the Official State Agency to qualify products for any of the other classifications described in § 145.10 as a condition of qualification for the U.S. Pullorum-Typhoid Clean classification. (g) Participation in the Plan shall entitle the participant to use the Plan emblem reproduced below: (Approved by the Office of Management and Budget under control number 0579-0007) [36 FR 23112, Dec. 3, 1971, as amended at 40 FR 1500, Jan. 8, 1975. Redesignated at 44 FR 61586, Oct. 26, 1979 and amended at 48 FR 57473, Dec. 30, 1983; 57 FR 57341, Dec. 4, 1992; 63 FR 40010, July 27, 1998; 65 FR 8016, Feb. 17, 2000; 79 FR 38754, July 9, 2014; 81 FR 53249, Aug. 12, 2016] § 145.4 General provisions for all participants. (a) Records of purchases and sales and the identity of products handled shall be maintained in a manner satisfactory to the Official State Agency. (b) Products, records of sales and purchase of products, and material used to advertise products shall be subject to inspection by the Official State Agency at any time. (c) Advertising must be in accordance with the Plan, and applicable rules and regulations of the Official State Agency and the Federal Trade Commission. A participant advertising products as being of any official classification may include in his advertising reference to associated or franchised hatcheries only when such hatcheries produce the same kind of products of the same classification. (d) Except as provided by this paragraph, participants in the Plan may not buy or receive products for any purpose from nonparticipants unless they are part of an equivalent program, as determined by the Official State Agency. Participants in the Plan may buy or receive products from flocks that are neither participants nor part of an equivalent program, for use in breeding flocks or for experimental purposes, under the following conditions only: (1) With the permission of the Official State Agency and the concurrence of the Service; and (2) By segregation of all birds before introduction into the breeding flock. Upon reaching sexual maturity, the segregated birds must be tested and found negative for pullorum-typhoid and any other disease for which the flock into which the birds are being introduced holds a disease classification. The Official State Agency may require a second test at its discretion. (e) Each participant shall be assigned a permanent approval number by the Service. This number, prefaced by the numerical code of the State, will be the official approval number of the participant and may be used on each certificate, invoice, shipping label, or other document used by the participant in the sale of his products. Each Official State Agency which requires an approval or permit number for out-of-State participants to ship into its State should honor this number. The approval number shall be withdrawn when the participant no longer qualifies for participation in the Plan. (Approved by the Office of Management and Budget under control number 0579-0057) [36 FR 23112, Dec. 3, 1971, as amended at 38 FR 13706, May 24, 1973; 41 FR 48723, Nov. 5, 1976. Redesignated at 44 FR 61586, Oct. 26, 1979, as amended at 47 FR 21991, May 20, 1982; 48 FR 57473, Dec. 30, 1983; 57 FR 57341, Dec. 4, 1992; 83 FR 28352, June 19, 2018] § 145.5 Specific provisions for participating flocks. (a) Poultry equipment, and poultry houses and the land in the immediate vicinity thereof, shall be kept in sanitary condition in accordance with part 147 of this subchapter. The participating flock, its eggs, and all equipment used in connection with the flock shall be separated from nonparticipating flocks, in a manner acceptable to the Official State Agency. (b) All flocks shall consist of healthy, normal individuals characteristic of the breed, variety, cross, or other combination which they are stated to represent. (c) A flock shall be deemed to be a participating flock at any time only if it has qualified for the U.S. Pullorum-Typhoid Clean classification, as prescribed in subparts B, C, D, E, F, G, H, I, or J of this part. (d) Each bird shall be identified with a sealed and numbered band obtained through or approved by the Official State Agency: Provided, [36 FR 23112, Dec. 3, 1971, as amended at 38 FR 13706, May 24, 1973. Redesignated at 44 FR 61586, Oct. 26, 1979, as amended at 63 FR 40010, July 27, 1998; 79 FR 38754, July 9, 2014; 90 FR 46745, Sept. 30, 2025] § 145.6 Specific provisions for participating hatcheries. (a) Hatcheries must be kept in sanitary condition, acceptable to the Official State Agency. The sanitary procedures outlined in the NPIP Program Standards, or other procedures approved by the Administrator in accordance with § 147.53(d), will be considered as a guide in determining compliance with this provision. The minimum requirements with respect to sanitation include the following: (1) Egg room walls, ceilings, floors, air filters, drains, and humidifiers should be cleaned and disinfected at least two times per week. Cleaning and disinfection procedures should be in accordance with part 147 of this subchapter. (2) Incubator room walls, ceilings, floors, doors, fan grills, vents, and ducts should be cleaned and disinfected after each set or transfer. Incubator rooms should not be used for storage. Plenums should be cleaned at least weekly. Egg trays and buggies should be cleaned and disinfected after each transfer. Cleaning and disinfection procedures should be in accordance with part 147 of this subchapter. (3) Hatcher walls, ceilings, floors, doors, fans, vents, and ducts should be cleaned and disinfected after each hatch. Hatcher rooms should be cleaned and disinfected after each hatch and should not be used for storage. Plenums should be cleaned after each hatch. Cleaning and disinfection procedures should be in accordance with part 147 of this subchapter. (4) Chick/poult processing equipment and rooms should be thoroughly cleaned and disinfected after each hatch. Chick/poult boxes should be cleaned and disinfected before being reused. Vaccination equipment should be cleaned and disinfected after each use. Cleaning and disinfection procedures should be in accordance with part 147 of this subchapter. (5) Hatchery residue, such as chick/poult down, eggshells, infertile eggs, and dead germs, should be disposed of promptly and in a manner satisfactory to the Official State Agency. (6) The entire hatchery should be kept in a neat, orderly condition and cleaned and disinfected after each hatch. (7) Effective insect and rodent control programs should be implemented. (b) A hatchery that keeps started poultry must keep such poultry separated from the incubator room in a manner satisfactory to the Official State Agency. (c) All baby and started poultry offered for sale under Plan terminology should be normal and typical of the breed, variety, cross, or other combination represented. (d) Eggs incubated should be sound in shell, typical for the breed, variety, strain, or cross thereof and reasonably uniform in shape. Hatching eggs should be trayed and the baby poultry boxed with a view to uniformity of size. (e) Any nutritive material provided to baby poultry must be free of the avian pathogens that are officially represented in the Plan disease classifications listed in § 145.10. (f) If a person is responsibly connected with more than one hatchery, all of such hatcheries must participate in the Plan if any of them participate. A person is deemed to be responsibly connected with a hatchery if he or she is a partner, officer, director, holder, owner of 10 percent or more of the voting stock, or an employee in a managerial or executive capacity. [36 FR 23112, Dec. 3, 1971. Redesignated at 44 FR 61586, Oct. 26, 1979, and amended at 49 FR 19802, May 10, 1984; 65 FR 8016, Feb. 17, 2000; 67 FR 8468, Feb. 25, 2002; 79 FR 38754, July 9, 2014] § 145.7 Specific provisions for participating dealers. Dealers in hatching eggs, newly hatched poultry, or started poultry shall comply with the provisions in this part (within the NPIP Program Standards document, Program Standard C applies to hatcheries; alternatives to the program standards may also be approved by the Administrator under § 147.53 of this subchapter). [85 FR 62564, Oct. 5, 2020] § 145.8 Terminology and classification; general. (a) The official classification terms defined in §§ 145.9 and 145.10 and the various designs illustrative of the official classifications reproduced in § 145.10 may be used only by participants and to describe products that have met all the specific requirements of such classifications. (b) Products produced under the Plan shall lose their identity under Plan terminology when they are purchased for resale by or consigned to nonparticipants. (c) Participating flocks, their eggs, and the baby and started poultry produced from them may be designated by their strain or trade name. When a breeder's trade name or strain designation is used, the participant shall be able by records to substantiate that the products so designated are from flocks that are composed of either birds hatched from eggs produced under the direct supervision of the breeder of such strain, or stock multiplied by persons designated and so reported by the breeder to each Official State Agency concerned. § 145.9 Terminology and classification; hatcheries and dealers. Participating hatcheries and dealers shall be designated as “National Plan Hatchery” and “National Plan Dealer”, respectively. All Official State Agencies shall be notified by the Service of additions, withdrawals, and changes in classification. [36 FR 23112, Dec. 3, 1971. Redesignated at 44 FR 61586, Oct. 26, 1979, and amended at 47 FR 21991, May 20, 1982] § 145.10 Terminology and classification; flocks, products, and States. Participating flocks, products produced from them, and States that have met the requirements of a classification in this part may be designated by the corresponding illustrative design in this section. (a) [Reserved] (b) U.S. Pullorum-Typhoid Clean. (c) U.S. M. Gallisepticum Clean. (d) U.S. Sanitation Monitored. (e) U.S. M. Synoviae Clean. (f) U.S. M. Meleagridis Clean (g) U.S. Pullorum-Typhoid Clean State. (h) U.S. Pullorum-Typhoid Clean State, Turkeys. (i) U.S.M. Gallisepticum Clean State, Turkeys. (j) U.S. M. Gallisepticum Clean State, Meat-Type Chickens. (k) U.S. Sanitation Monitored, Turkeys. Figure 12 (l) [Reserved] (m) U.S. S. Enteritidis Clean. (n) U.S. M. Synoviae Clean State, Turkeys. (o) U.S. Salmonella Monitored. (p) U.S. M. Gallisepticum Monitored. (q) U.S. M. Synoviae Monitored. (r) U.S. Avian Influenza Clean. (s) U.S. M. Meleagridis Clean State, Turkeys. (t) U.S. H5/H7 Avian Influenza Clean. (u) U.S. Newcastle Clean. Figure 22 (v) U.S. Avian Influenza Clean Compartment. Figure 23 (w) U.S. Newcastle Disease Clean Compartment. (See §§ 145.45, 145.74, and 145.84.) Figure 24 [38 FR 13706, May 24, 1973. Redesignated at 44 FR 61586, Oct. 26, 1979] Editorial Note: For Federal Register www.govinfo.gov. § 145.11 Supervision. (a) The Official State Agency may designate qualified persons as Authorized Agents to do the sample collecting provided for in § 145.14 and may designate qualified persons as Authorized Testing Agents to do the sample collecting and blood testing provided for in § 145.14. (b) The Official State Agency shall employ or authorize qualified persons as State Inspectors to perform the qualification testing of participating flocks, and to perform the official inspections necessary to verify compliance with the requirements of the Plan. (c) Authorities issued under the provisions of this section shall be subject to cancellation by the official State agency on the grounds of incompetence or failure to comply with the provisions of the Plan or regulations of the official State agency. Such actions shall not be taken until a thorough investigation has been made by the official State agency and the authorized person has been given notice of the proposed action and the basis therefor and an opportunity to present his views. [36 FR 23112, Dec. 3, 1971, as amended at 38 FR 13706, May 24, 1973; 41 FR 48723, Nov. 5, 1976. Redesignated at 44 FR 61586, Oct. 26, 1979, as amended at 72 FR 1418, Jan. 12, 2007] § 145.12 Inspections. (a) Each participating hatchery shall be audited at least one time annually or a sufficient number of times each year to satisfy the Official State Agency that the operations of the hatchery are in compliance with the provisions of the Plan. (b) The records of all flocks maintained primarily for production of hatching eggs shall be made available to and examined annually by a State Inspector. Records shall include VS Form 9-2, “Flock Selecting and Testing Report”; VS Form 9-3, “Report of Sales of Hatching Eggs, Chicks, and Poults”; set and hatch records; egg receipts; and egg/chick orders or invoices. Records shall be maintained for 3 years. On-site inspections of flocks and premises will be conducted if the State Inspector determines that a breach of sanitation, blood testing, or other provisions has occurred for Plan programs for which the flocks have or are being qualified. [36 FR 23112, Dec. 3, 1971, as amended at 40 FR 1501, Jan. 8, 1975. Redesignated at 44 FR 61586, Oct. 26, 1979, and amended at 54 FR 23955, June 5, 1989; 59 FR 12798, Mar. 18, 1994; 72 FR 1418, Jan. 12, 2007; 81 FR 53249, Aug. 12, 2016] § 145.13 Debarment from participation. Participants in the Plan, who after investigation by the Official State Agency or its representative, are notified in writing of their apparent noncompliance with the Plan provisions or regulations of the Official State Agency, shall be afforded a reasonable time, as specified by the Official State Agency, within which to demonstrate or achieve compliance. If compliance is not demonstrated or achieved within the specified time, the Official State Agency may debar the participant from further participation in the Plan for such period, or indefinitely, as the Agency may deem appropriate. The debarred participant shall be afforded notice of the bases for the debarment and opportunity to present his views with respect to the debarment in accordance with procedures adopted by the Official State Agency. The Official State Agency shall thereupon decide whether the debarment order shall continue in effect. Such decision shall be final unless the debarred participant, within 30 days after the issuance of the debarment order, requests the Administrator to determine the eligibility of the debarred participant for participation in the Plan. In such event the Administrator shall determine the matter de novo in accordance with the rules of practice in 7 CFR part 50, which are hereby made applicable to proceedings before the Administrator under this section. The definitions in 7 CFR 50.10 and the following definitions shall apply with respect to terms used in such rules of practice: (a) Administrator [36 FR 23112, Dec. 3, 1971, as amended at 38 FR 3038, Feb. 1, 1973. Redesignated at 44 FR 61586, Oct. 26, 1979, and amended at 47 FR 21991, May 20, 1982; 67 FR 8468, Feb. 25, 2002] § 145.14 Testing. Poultry must be more than 4 months of age when tested for an official classification with the following exceptions: Turkey candidates under subpart D of this part may be tested at more than 12 weeks of age; game bird candidates under subpart E or subpart J of this part may be tested when more than 4 months of age or upon reaching sexual maturity, whichever comes first; and ostrich, emu, rhea, and cassowary candidates under subpart F of this part may be tested when more than 12 months of age. Samples for official tests shall be collected by an Authorized Agent, Authorized Testing Agent, or State Inspector and tested by an authorized laboratory, except that the stained antigen, rapid whole-blood test for pullorum-typhoid may be conducted by an Authorized Testing Agent or State Inspector. Testing must be conducted as specified within the Subpart Plan program, with at least 1 bird tested from each pen and unit in the house and a minimum of 30 birds tested per house. The ratio of samples collected from male and female birds must be representative of birds throughout the house and flock. In houses containing fewer than 30 birds other than ostriches, emus, rheas, and cassowaries, all birds in the house must be tested, unless otherwise specified within the Plan program. (a) For Pullorum-Typhoid. 1 1 (2) [Reserved] (3) There shall be an interval of at least 21 days between any official blood test and any previous test with pullorum-typhoid antigen. (4) [Reserved] (5) The official blood test shall include the testing of a sample of blood from each bird in the flock: Provided, That under specified conditions (see applicable provisions of §§ 145.23, 145.33, 145.43, 145.53, 145.63, 145.73, 145.83, 145.93, and 145.103) the testing of a portion or sample of the birds may be used in lieu of testing each bird. (6) Poultry from flocks undergoing qualification testing for participation in the Plan that have a positive reaction to an official blood test named in paragraph (a)(1) of this section shall be evaluated for pullorum-typhoid as follows: (i) Serum samples that react on rapid serum test or enzyme-labeled immunosorbent assay test (ELISA), or blood from birds that react on the stained antigen, rapid whole-blood test for all birds except turkeys, shall be tested with either the standard tube agglutination test or the microagglutination test. (ii) Reactors to the standard tube agglutination test (in dilutions of 1:50 or greater) or the microagglutination test (in dilutions of 1:40 or greater) shall be submitted to an authorized laboratory for bacteriological examination. If there are more than four reactors in a flock, a minimum of four reactors shall be submitted to the authorized laboratory; if the flock has four or fewer reactors, all of the reactors must be submitted. Bacteriological examination must be conducted in accordance with part 147 of this subchapter (within the Program Standards document, Program Standard B addresses bacteriological examination procedures; alternatives to the program standards may also be approved by the Administrator under § 145.73). When reactors are submitted to the authorized laboratory within 10 days of the date of reading an official blood test named in paragraph (a)(6)(i) of this section, and the bacteriological examination fails to demonstrate pullorum-typhoid infection, the Official State Agency shall presume that the flock is determined not to be infected with Salmonella Salmonella (iii) If a flock owner does not wish to submit reactors for bacteriological examination, then the reactors shall be isolated and retested within 30 days using an official blood test named in paragraph (a)(1) of this section. If this retest is positive, additional examination of the reactors and flock will be performed in accordance with paragraph (a)(6)(ii) of this section. During this 30-day period, the flock must be maintained under a security system, specified or approved by the Official State Agency, that will prevent physical contact with other birds and assure that personnel, equipment, and supplies that could be a source of pullorum-typhoid spread are sanitized. (7) When Salmonella Salmonella Salmonella Salmonella 2 2 Salmonella Salmonella (i) The taking of blood samples—performed by or in the presence of a State Inspector—from all birds on premises exposed to birds, equipment, supplies, or personnel from the primary breeding flock during the period when the State Inspector determined that exposure to Salmonella Salmonella 2 (ii) The banding of all birds of these premises—performed or physically supervised by a State Inspector—in order to identify any bird that tests positive; and (iii) The testing of blood samples at an authorized laboratory using an official blood test named in paragraph (a)(1) of this section. (8) All domesticated fowl, except waterfowl, on the farm of the participant shall either be properly tested to meet the same standards as the participating flock or these birds and their eggs shall be separated from the participating flock and its eggs. (9) All tests for pullorum-typhoid in flocks participating in or candidates for participation in the Plan shall be reported to the Official State Agency within 10 days following the completion of such tests. All reactors shall be considered in determining the classification of the flock. (10) Any drug, for which there is scientific evidence of masking the test reaction or hindering the bacteriological recovery of Salmonella organisms, shall not be fed or administered to poultry within 3 weeks prior to a test or bacteriological examination upon which a Salmonella classification is based. (11) When suitable evidence, as determined by the Official State Agency or the State Animal Disease Control Official, indicates that baby or started poultry produced by participating hatcheries are infected with organisms for which the parent flock received an official control classification and this evidence indicates that the infection was transmitted from the parent flock, the Official State Agency may, at its discretion, require additional testing of the flock involved. If infection is found in the parent flock, its classification shall be suspended until the flock is requalified under the requirements for the classification. Furthermore, the Official State Agency may require that the hatching eggs from such flocks be removed from the incubator and destroyed prior to hatching. When Salmonella organisms are isolated from a specimen which originated in a participating hatchery, the Official State Agency shall attempt to locate the source of the infection. The results of the investigation and the action taken to eliminate the infection shall be reported by the Official State Agency to the Service. (b) For Mycoplasma gallisepticum, M. meleagridis, and M. synoviae. M. gallisepticum, M. meleagridis, M. synoviae 3 3 A.A. Ansari, R.F. Taylor, T.S. Chang, “Application of Enzyme-Linked Immunosorbent Assay for Detecting Antibody to Mycoplasma gallisepticum Infections in Poultry,” Avian Diseases, H.M. Opitz, J.B. Duplessis, and M.J. Cyr, “Indirect Micro-Enzyme-Linked Immunosorbent Assay for the Detection of Antibodies to Mycoplasma synoviae and M. gallisepticum,” Avian Diseases, H.B. Ortmayer and R. Yamamoto, “Mycoplasma Meleagridis Antibody Detection by Enzyme-Linked Immunosorbent Assay (ELISA),” Proceedings, 30th Western Poultry Disease Conference, (2) The serological tests shall be conducted using M. gallisepticum M. meleagridis, M. synoviae (3) When reactors to the test for which the flock was tested are submitted to a laboratory as prescribed by the Official State Agency, the final status of the flock will be determined in accordance with part 147 of this subchapter. (4) Any drug, for which there is scientific evidence of masking the test reaction or hindering the bacteriological recovery of mycoplasma organisms, shall not be fed or administered to poultry within three weeks prior to a test or bacteriological examination upon which a Mycoplasma classification is based. (5) The official molecular examination procedures for M. gallisepticum M. synoviae (c) [Reserved] (d) For avian influenza. (1) Antibody detection tests Enzyme-linked immunosorbent assay (ELISA) test. (B) When positive ELISA samples are identified, an AGID test must be conducted within 48 hours. (ii) Agar gel immunodiffusion (AGID) test. (B) The AGID test for avian influenza must be conducted in accordance with this section (within the NPIP Program Standards document, Program Standard A applies to blood and yolk testing procedures; alternatives to the program standards may also be approved by the Administrator under § 147.53 of this subchapter) for the avian influenza agar gel immunodiffusion (AGID) test. The test can be conducted on egg yolk or blood samples. The AGID test is not recommended for use in waterfowl. (C) Positive tests for the AGID must be further tested by Federal Reference Laboratories using appropriate tests for confirmation. Final judgment may be based upon further sampling and appropriate tests for confirmation. (2) Agent detection tests. (i) The real time reverse transcriptase/polymerase chain reaction (RRT-PCR) assay. ( 1 ( 2 ( 3 ( 4 ( 5 (B) Positive results from the RRT-PCR must be further tested by Federal Reference Laboratories using appropriate tests for confirmation. Final judgment may be based upon further sampling and appropriate tests for confirmation. (ii) USDA-licensed type A influenza antigen capture immunoassay (ACIA). (B) Chicken and turkey flocks that test positive on the ACIA must be further tested using the RRT-PCR or virus isolation. Positive results from the RRT-PCR or virus isolation must be further tested by Federal Reference Laboratories using appropriate tests for confirmation. Final judgment may be based upon further sampling and appropriate tests for confirmation. (3) The official determination of a flock as positive for the H5 or H7 subtypes of avian influenza may be made only by NVSL. (e) For Newcastle Disease (ND). (Approved by the Office of Management and Budget under control number 0579-0007) [36 FR 23112, Dec. 3, 1971] Editorial Note: For Federal Register www.govinfo.gov. § 145.15 Diagnostic surveillance program for low pathogenic avian influenza. (a) The Official State Agency must develop a diagnostic surveillance program for H5/H7 low pathogenic avian influenza for all poultry in the State. The exact provisions of the program are at the discretion of the States. The Service will use the standards in paragraph (b) of this section in assessing individual State plans for adequacy, including the specific provisions that the State developed. The standards should be used by States in developing those plans. (b) Avian influenza 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 avian influenza by both an approved serological test and an approved antigen detection test. Memoranda of understanding or other means must be used to establish testing and reporting criteria (including criteria that provide for reporting H5 and H7 low pathogenic avian influenza directly to the Service) and approved testing methods. In addition, States should conduct outreach to poultry producers, especially owners of smaller flocks, regarding the importance of prompt reporting of clinical symptoms consistent with avian influenza. [74 FR 14715, Apr. 1, 2009] Subpart B—Special Provisions for Multiplier Egg-Type Chicken Breeding Flocks and Products § 145.21 Definitions. Except where the context otherwise requires, for the purposes of this subpart the following terms shall be construed, respectively, to mean: Chicks. Egg type chicken breeding flocks. Started chickens. [36 FR 23112, Dec. 3, 1971, as amended at 38 FR 13707, May 24, 1973; 41 FR 48723, Nov. 5, 1976. Redesignated at 44 FR 61586, Oct. 26, 1979, and amended at 59 FR 12798, Mar. 18, 1994; 65 FR 8017, Feb. 17, 2000] § 145.22 Participation. Participating flocks of multiplier egg type chickens, and the eggs and chicks produced from them, shall comply with the applicable general provisions of subpart A of this part and the special provisions of this subpart B. (a) Started chickens shall lose their identity under Plan terminology when not maintained by Plan participants under the conditions prescribed in § 145.5(a). (b) Hatching eggs produced by multiplier breeding flocks should be nest clean. They may be fumigated in accordance with part 147 of this subchapter or otherwise sanitized. (c) Any nutritive material provided to chicks must be free of the avian pathogens that are officially represented in the Plan disease classifications listed in § 145.10. [36 FR 23112, Dec. 3, 1971, as amended at 40 FR 1501, Jan. 8, 1975. Redesignated at 44 FR 61586, Oct. 26, 1979, and amended at 49 FR 19802, May 10, 1984; 57 FR 57341, Dec. 4, 1992; 65 FR 8017, Feb. 17, 2000; 68 FR 64510, Nov. 14, 2003; 72 FR 1419, Jan. 12, 2007; 79 FR 38755, July 9, 2014] § 145.23 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. Provided, (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 Salmonella Salmonella (2) It is a multiplier breeding flock 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, (3) It is a multiplier breeding flock 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 hatcheries within the State are qualified as “National Plan Hatcheries” or have met equivalent requirements for pullorum-typhoid control under official supervision; (ii) 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, (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, (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) 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; (viii) Discontinuation of any of the conditions or procedures described in paragraphs (b)(3)(i), (ii), (iii), (iv), (v), (vi), and (vii) 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. (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 (b)(3) of this section, and 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. (c) U.S. M. Gallisepticum Clean. M. gallisepticum (i) [Reserved] (ii) It is a multiplier breeding flock which originated as U.S. M. Gallisepticum Clean chicks from primary breeding flocks and from which a sample comprised of a minimum of 150 birds per flock has been tested for M. gallisepticum Provided, (A) At intervals of not more than 90 days, 75 birds from the flock shall be tested, Provided, (B) At intervals of not more than 30 days, a sample of 25 cull chicks produced from the flock shall be subjected to laboratory procedures acceptable to the Official State Agency and approved by the Service, for the detection and recovery of M. gallisepticum (C) At intervals of not more than 30 days, egg yolk testing shall be conducted in accordance with part 147 of this subchapter. (2) A participant handling U.S. M. Gallisepticum Clean products shall keep these products separate from other products in a manner satisfactory to the Official State Agency. (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. S. Enteritidis Clean. Salmonella enteritidis. (1) A flock and the hatching eggs and chicks produced from it which have met the following requirements as determined by the Official State Agency: (i) The flock originated from a U.S. Salmonella (ii) All feed fed to the flock shall meet the following requirements: (A) Pelletized feed shall contain either no animal protein or only animal protein products produced under the Animal Protein Products Industry (APPI) Salmonella (B) Mash feed may contain no animal protein other than an APPI animal protein product supplement manufactured in pellet form and crumbled: Provided, (iii) Feed shall be stored and transported in such a manner as to prevent possible contamination; (iv) The flock is maintained in accordance with part 147 of this subchapter with respect to flock sanitation, cleaning and disinfection, and Salmonella isolation, sanitation, and management. Rodents and other pests should be effectively controlled; (v) Environmental samples shall be collected from the flock by an Authorized Agent, in accordance with part 147 of this subchapter, when the flock is 2 to 4 weeks of age. The samples shall be examined bacteriologically for group D salmonella at an authorized laboratory. Cultures from positive samples shall be serotyped. The authorized agent shall also collect samples every 30 days after the first sample has been collected. (vi) Hatching eggs are collected as quickly as possible, and their sanitation is maintained in accordance with part 147 of this subchapter. (vii) Hatching eggs produced by the flock are incubated in a hatchery whose sanitation is maintained in accordance with part 147 of this subchapter and sanitized either by a procedure approved by the Official State Agency or in accordance with part 147 of this subchapter. (2) A flock shall not be eligible for this classification if Salmonella (3) In order for a hatchery to sell products of this classification, 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. (e) U.S.M. Synoviae Clean. M. synoviae (i) [Reserved] (ii) It is a multiplier breeding flock which originated as U.S. M. Synoviae Clean chicks from primary breeding flocks and from which a sample comprised of a minimum of 150 birds has been tested for M. synoviae Provided, (A) At intervals of not more than 90 days, 75 birds from the flock shall be tested: Provided, (B) At intervals of not more than 30 days, egg yolk testing shall be conducted in accordance with part 147 of this subchapter. (2) A participant handling U.S. M. Synoviae Clean products shall keep these products separate from other products in a manner satisfactory to the Official State Agency. (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. (f) U.S. M. Gallisepticum Clean Started Poultry. (2) All other poultry on the premises of the candidate flock must originate from U.S. M. Gallisepticum Clean sources. (3) The flock is maintained in accordance with part 147 of this subchapter with respect to Mycoplasma isolation, sanitation, and management. (4) The flock's freedom from M. Gallisepticum (5) Started poultry shall be delivered to and from the farm premises in crates and vehicles which have been cleaned and disinfected in accordance with part 147 of this subchapter. (g) U.S. M. Synoviae Clean Started Poultry. (2) All other poultry on the premises of the candidate flock must originate from U.S. M. Synoviae Clean sources. (3) The flock is maintained in accordance with part 147 of this subchapter with respect to Mycoplasma isolation, sanitation, and management. (4) The flock's freedom from M. synoviae (5) Started poultry shall be delivered to and from the farm premises in crates and vehicles which have been cleaned and disinfected in accordance with part 147 of this subchapter. (h) U.S. Avian Influenza Clean. (1) It is a multiplier breeding flock in which a minimum of 30 birds have been tested and found negative to avian influenza 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) A sample of at least 11 birds must be tested and found negative to avian influenza within 21 days prior to slaughter. (Approved by the Office of Management and Budget under control number 0579-0007) [36 FR 23112, Dec. 3, 1971] Editorial Note: For Federal Register www.govinfo.gov. § 145.24 Terminology and classification; States. (a) U.S. Pullorum-Typhoid Clean State. (i) The State is in compliance with the provisions contained in §§ 145.23(b)(3)(i) through (vii), 145.33(b)(3)(i) through (vii), 145.43(b)(3)(i) through (vi), 145.53(b)(3)(i) through (vii), 145.73(b)(2)(i), 145.83(b)(2)(i), 145.93(b)(3)(i) through (vii), and 145.103(b)(3)(i) through (ix). (ii) No pullorum disease or fowl typhoid is known to exist nor to have existed in hatchery supply flocks within the State during the preceding 12 months: Provided, (2) Discontinuation of any of the conditions described in paragraph (a)(1)(i) of this section, or repeated outbreaks of pullorum or typhoid occur in hatchery supply flocks described in paragraph (a)(1)(ii) of this section, or if an infection spreads from the originating premises, the Service shall have grounds to revoke its determination that the State is entitled to this classification. 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 for a hearing in accordance with rules of practice adopted by the Administrator. (b) [Reserved] [40 FR 1502, Jan. 8, 1975. Redesignated at 44 FR 61586, Oct. 26, 1979, and amended at 54 FR 23957, June 5, 1989; 67 FR 8469, Feb. 25, 2002; 72 FR 1419, Jan. 12, 2007; 76 FR 15793, Mar. 22, 2011; 85 FR 62565, Oct. 5, 2020] Subpart C—Special Provisions for Multiplier Meat-Type Chicken Breeding Flocks and Products § 145.31 Definitions. Except where the context otherwise requires, for the purposes of this subpart the following terms shall be construed, respectively, to mean: Chicks. Meat type chicken breeding flocks. Started chickens. [36 FR 23112, Dec. 3, 1971, as amended at 41 FR 48724, Nov. 5, 1976. Redesignated at 44 FR 61586, Oct. 26, 1979, and amended at 59 FR 12799, Mar. 18, 1994; 65 FR 8018, Feb. 17, 2000] § 145.32 Participation. Participating flocks of multiplier meat type chickens, and the eggs and chicks produced from them, shall comply with the applicable general provisions of subpart A of this part and the special provisions of this subpart C. (a) Started chickens shall lose their identity under Plan terminology when not maintained by Plan participants under the conditions prescribed in § 145.5(a). (b) Hatching eggs produced by multiplier breeding flocks should be nest clean. They may be fumigated in accordance with part 147 of this subchapter or otherwise sanitized. (c) Any nutritive material provided to chicks must be free of the avian pathogens that are officially represented in the Plan disease classifications listed in § 145.10. [36 FR 23112, Dec. 3, 1971, as amended at 40 FR 1502, Jan. 8, 1975; 41 FR 48724, Nov. 5, 1976. Redesignated at 44 FR 61586, Oct. 26, 1979, and amended at 49 FR 19802, May 10, 1984; 57 FR 57341, Dec. 4, 1992; 65 FR 8018, Feb. 17, 2000; 68 FR 64510, Nov. 14, 2003; 72 FR 1419, Jan. 12, 2007; 79 FR 38756, July 9, 2014] § 145.33 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. Provided, (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 Salmonella Salmonella (2) It is a multiplier breeding flock 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, (3) It is a multiplier breeding flock 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 hatcheries within the State are qualified as “National Plan Hatcheries” or have met equivalent requirements for pullorum-typhoid control under official supervision; (ii) 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, (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, (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) 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; (viii) Discontinuation of any of the conditions or procedures described in paragraphs (b)(3)(i), (ii), (iii), (iv), (v), (vi), and (vii) 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. (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 hatchery supply flocks within the State during the preceding 12 months. (c) U.S. M. Gallisepticum Clean. M. gallisepticum (i) [Reserved] (ii) It is a multiplier breeding flock which originated as U.S. M. Gallisepticum Clean chicks from primary breeding flocks and from which a sample comprised of a minimum of 150 birds per flock has been tested for M. gallisepticum Provided, (A) At intervals of not more than 90 days, 75 birds from the flock shall be tested, Provided, (B) At intervals of not more than 30 days, a sample of 25 cull chicks produced from the flock shall be subjected to laboratory procedures acceptable to the Official State Agency and approved by the Service, for the detection and recovery of M. gallisepticum (C) At intervals of not more than 30 days, egg yolk testing shall be conducted in accordance with part 147 of this subchapter. (2) A participant handling U.S. M. Gallisepticum Clean products must keep these products separate from other products through the use of separate hatchers and incubators, separate hatch days, and proper hatchery sanitation and biosecurity in a manner satisfactory to the Official State Agency and in accordance with part 147 of this subchapter. (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. (4) Before male breeding birds may be added to a participating multiplier breeding flock, a sample of at least 30 birds to be added, with a minimum of 10 birds per pen, shall be tested for M. gallisepticum M. gallisepticum, (d) U.S. Sanitation Monitored. (1) A flock and the hatching eggs and chicks produced from it which have met the following requirements as determined by the Official State Agency: (i) The flock shall originate from a source where sanitation and management practices, as outlined in § 145.33(d)(1) of this paragraph, are conducted; (ii) The flock is maintained in accordance with part 147 of this subchapter with respect to flock sanitation, cleaning and disinfection, and Salmonella isolation, sanitation, and management; (iii) If pelletized feed contains animal protein, the protein products shall be purchased from participants in the Animal Protein Products Industry (APPI) Salmonella (iv) If mash feed contains animal protein, the protein products shall be purchased from participants in the Animal Protein Products Industry (APPI) Salmonella (v) Feed shall be stored and transported in such a manner as to prevent possible contamination; (vi) 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; (vii) 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 90 days thereafter. An authorized laboratory for Salmonella (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 this classification, 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. (e) U.S. M. Synoviae Clean. M. synoviae (i) [Reserved] (ii) It is a multiplier breeding flock which originated as U.S. M. Synoviae Clean chicks from primary breeding flocks and from which a sample comprised of a minimum of 150 birds has been tested for M. synoviae Provided, (A) At intervals of not more than 90 days, 75 birds from the flock shall be tested: Provided, (B) At intervals of not more than 30 days, egg yolk testing shall be conducted in accordance with part 147 of this subchapter. (2) A participant handling U.S. M. Synoviae Clean products shall keep these products separate from other products in a manner satisfactory to the official State Agency. (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. (4) Before male breeding birds may be added to a participating multiplier breeding flock, a sample of at least 30 birds to be added, with a minimum of 10 birds per pen, shall be tested for M. synoviae M. synoviae, (f) U.S. M. Gallisepticum Clean Started Poultry. (2) All other poultry on the premises of the candidate flock must originate from U.S. M. Gallisepticum Clean sources. (3) The flock is maintained in accordance with part 147 of this subchapter with respect to Mycoplasma isolation, sanitation, and management. (4) The flock's freedom from M. gallisepticum (5) Started poultry shall be delivered to and from the farm premises in crates and vehicles which have been cleaned and disinfected in accordance with part 147 of this subchapter. (g) U.S. M. Synoviae Clean Started Poultry. (2) All other poultry on the premises of the candidate flock must originate from U.S. M. Synoviae Clean sources. (3) The flock is maintained in accordance with part 147 of this subchapter with respect to Mycoplasma isolation, sanitation, and management. (4) The flock's freedom from M. synoviae (5) Started poultry shall be delivered to and from the farm premises in crates and vehicles which have been cleaned and disinfected in accordance with part 147 of this subchapter. (h)-(i) [Reserved] (j) U.S. M. Gallisepticum Monitored. M. gallisepticum Provided, And provided further, (2) A participant handling U.S. M. Gallisepticum Monitored products shall keep these products separate from other products in a manner satisfactory to the Official State Agency: Provided, (3) U.S. M. Gallisepticum Monitored 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. (k) U.S. M. Synoviae Monitored. M. synoviae Provided, And provided further, (2) A participant handling U.S. M. Synoviae Monitored products shall keep these products separate from other products in a manner satisfactory to the Official State Agency: Provided, (3) U.S. M. Synoviae Monitored 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. (l) U.S. Avian Influenza Clean. (1) It is a multiplier 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 15 birds must be tested negative at intervals of 90 days; or (ii) A sample of fewer than 15 birds may be tested, and found to be negative, at any one time if all pens are equally represented and a total of 15 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 15 samples are collected and tested within each 90-day period; and (iv) Fifteen (15) birds are tested and found negative for avian influenza within 21 days prior to movement to slaughter regardless of the date of the previous test. (2) [Reserved] (m) U.S. Salmonella Enteritidis Monitored. 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 primary meat-type breeding flock. (ii) The flock is maintained in accordance with part 147 of this subchapter with respect to Salmonella isolation, sanitation, and management. (iii) Environmental samples are collected from the flock in accordance with part 147 of this subchapter at 16-18 and 40-45 weeks of age. The samples shall be examined bacteriologically for group D Salmonella at an authorized laboratory, and cultures from group D positive samples shall be serotyped. (2) The following actions must be taken with respect to the test results that are generated from this Salmonella (i) If Salmonella (ii)-(iv) [Reserved] (3) This classification may be revoked by the Official State Agency if the participant fails to comply with the requirements of this classification. 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. (Approved by the Office of Management and Budget under control number 0579-0007) [36 FR 23112, Dec. 3, 1971] Editorial Note: For Federal Register www.govinfo.gov. § 145.34 Terminology and classification; States. (a) U.S. Pullorum-Typhoid-Clean State. (i) The State is in compliance with the provisions contained in §§ 145.23(b)(3)(i) through (vii), 145.33(b)(3)(i) through (vii), 145.43(b)(3)(i) through (vi), 145.53(b)(3)(i) through (vii), 145.73(b)(2)(i), 145.83(b)(2)(i), 145.93(b)(3)(i) through (vii), and 145.103(b)(3)(i) through (ix). (ii) No pullorum disease or fowl typhoid is known to exist nor to have existed in hatchery supply flocks within the State during the preceding 12 months: Provided, (2) Discontinuation of any of the conditions described in paragraph (a)(1)(i) of this section, or repeated outbreaks of pullorum or typhoid occur in hatchery supply flocks described in paragraph (a)(1)(ii) of this section, or if an infection spreads from the originating premises, the Service shall have grounds to revoke its determination that the State is entitled to this classification. 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 for a hearing in accordance with rules of practice adopted by the Administrator. (b) U.S. M. Gallisepticum Clean State, Meat-Type Chickens. (i) No M. gallisepticum (ii) All meat-type chicken breeding flocks in production are classified as U.S. M. Gallisepticum Clean in accordance with §§ 145.33(c) and 145.83(c) or have met equivalent requirements for M. gallisepticum (iii) All hatcheries within the State which handle products from meat-type chicken breeding flocks only handle products which are classified as U.S. M. Gallisepticum Clean or have met equivalent requirements for M. gallisepticum (iv) All shipments of products from meat-type chicken breeding flocks other than those classified as U.S. M. Gallisepticum Clean, or equivalent, into the State are prohibited; (v) 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 specimens from chickens from meat-type chicken breeding flocks that have been identified as being infected with M. gallisepticum (vi) All reports of M. gallisepticum (vii) All chickens from meat-type chicken breeding flocks found to be infected with M. gallisepticum (2) Discontinuation of any of the conditions described in paragraph (b)(1) of this section, or if repeated outbreaks of M. gallisepticum [40 FR 1503, Jan. 8, 1975. Redesignated at 44 FR 61586, Oct. 26, 1979, and amended at 50 FR 19899, May 13, 1985; 54 FR 23957, June 5, 1989; 67 FR 8469, Feb. 25, 2002; 72 FR 1419, Jan. 12, 2007; 76 FR 15793, Mar. 22, 2011; 85 FR 62565, Oct. 5, 2020] Subpart D—Special Provisions for Turkey Breeding Flocks and Products § 145.41 Definitions. Except where the context otherwise requires, for the purposes of this subpart the following terms shall be construed, respectively, to mean: Poults. [36 FR 23112, Dec. 3, 1971, as amended at 41 FR 48725, Nov. 5, 1976. Redesignated at 44 FR 61586, Oct. 26, 1979, and amended at 59 FR 12799, Mar. 18, 1994; 65 FR 8018, Feb. 17, 2000] § 145.42 Participation. (a) Participating turkey flocks, and the eggs and poults produced from them, shall comply with the applicable general provisions of subpart A of this part and the special provisions of this subpart D. (b) Hatching eggs should be nest clean. They may be fumigated in accordance with part 147 of this subchapter or otherwise sanitized. (c) Any nutritive material provided to poults must be free of the avian pathogens that are officially represented in the Plan disease classifications listed in § 145.10. [36 FR 23112, Dec. 3, 1971, as amended at 38 FR 13707, May 24, 1973; 40 FR 1503, Jan. 8, 1975. Redesignated at 44 FR 61586, Oct. 26, 1979, and amended at 49 FR 19802, May 10, 1984; 57 FR 57341, Dec. 4, 1992; 65 FR 8018, Feb. 17, 2000; 68 FR 64511, Nov. 14, 2003; 79 FR 38757, July 9, 2014; 81 FR 53249, Aug. 12, 2016] § 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. Provided, (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 Salmonella Salmonella (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, (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, (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, (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 Salmonella Salmonella Provided, (c) U.S. M. Gallisepticum Clean. M. Gallisepticum (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 M. gallisepticum, (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. M. meleagridis (i) A sample of 100 birds from each flock has been tested for M. meleagridis Provided, (ii) [Reserved] (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 (e) U.S. M. Synoviae Clean. M. synoviae Provided, M. synoviae (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. (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, (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 (ii) Mash feed should be treated with an FDA-approved Salmonella (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 (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) 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. (6) 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. (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. (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 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 (ii) 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 0579-0007) [36 FR 23112, Dec. 3, 1971] Editorial Note: For Federal Register www.govinfo.gov. § 145.44 Terminology and classification; States. (a) U.S. Pullorum-Typhoid Clean State. (i) The State is in compliance with the provisions contained in §§ 145.23(b)(3)(i) through (vii), 145.33(b)(3)(i) through (vii), 145.43(b)(3)(i) through (vi), 145.53(b)(3)(i) through (vii), 145.73(b)(2)(i), § 145.83(b)(2)(i), 145.93(b)(3)(i) through (vii), and 145.103(b)(3)(i) through (ix). (ii) No pullorum disease or fowl typhoid is known to exist nor to have existed in hatchery supply flocks within the State during the preceding 12 months: Provided, (2) Discontinuation of any of the conditions described in paragraph (a)(1)(i) of this section, or repeated outbreaks of pullorum or typhoid occur in hatchery supply flocks described in paragraph (a)(1)(ii) of this section, or if an infection spreads from the originating premises, the Service shall have grounds to revoke its determination that the State is entitled to this classification. 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 for a hearing in accordance with rules of practice adopted by the Administrator. (b) U.S. Pullorum-Typhoid Clean State, Turkeys. (i) The State is in compliance with the provisions contained in § 145.43(b)(3)(i) through (vi). (ii) No pullorum disease or fowl typhoid is known to exist nor to have existed in turkey hatchery supply flocks within the State during the preceding 24 months. (2) Discontinuation of any of the conditions described in paragraph (b)(1)(i) of this section, or repeated outbreaks of pullorum or typhoid occur in hatchery supply flocks described in paragraph (b)(1)(ii) of this section, or if an infection spreads from the originating premises, Service shall have grounds to revoke its determination that the State is entitled to this classification. 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 for a hearing in accordance with rules of practice adopted by the Administrator. (c) U.S. M. Gallisepticum Clean State, Turkeys. (i) No M. gallisepticum (ii) All turkey breeding flocks in production are classified as U.S. M. Gallisepticum Clean or have met equivalent requirements for M. gallisepticum (iii) All turkey hatcheries within the State handle products which are classified as U.S. M. Gallisepticum Clean or have met equivalent requirements for M. gallisepticum (iv) All shipments of turkey products other than those classified as U.S. M. Gallisepticum Clean, or equivalent, into the State are prohibited. (v) 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 turkey specimens that have been identified as being infected with M. gallisepticum. (vi) All reports of M. gallisepticum (vii) All turkey flocks found to be infected with M. gallisepticum (2) Discontinuation of any of the conditions described in paragraph (c)(1) of this section, or if repeated outbreaks of M. gallisepticum (3) If a State retains this status for 2 or more years, individual breeding flocks in the State may qualify for an M. gallisepticum (d) U.S. M. Synoviae Clean State, Turkeys. (i) No Mycoplasma synoviae (ii) All turkey breeding flocks in production are tested and classified as U.S. M. Synoviae Clean or have met equivalent requirements for M. synoviae (iii) All turkey hatcheries within the State only handle products that are classified as U.S. M. Synoviae Clean or have met equivalent requirements for M. synoviae (iv) All shipments of products from turkey breeding flocks other than those classified as U.S. M. Synoviae Clean, or equivalent, into the State are prohibited; (v) 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 turkey specimens that have been identified as being infected with M. synoviae; (vi) All reports of M. synoviae (vii) All turkey breeding flocks found to be infected with M. synoviae (2) The Service may revoke the State's classification as a U.S. M. Synoviae Clean State, Turkeys, if any of the conditions described in paragraph (d)(1) of this section are discontinued. The Service shall not revoke the State's classification as a U.S. M. Synoviae Clean State, Turkeys, until it has conducted an investigation and the Official State Agency has been given an opportunity for a hearing in accordance with rules of practice adopted by the Administrator of the Service. (e) U.S. M. Meleagridis Clean State, Turkeys. (i) No Mycoplasma meleagridis (ii) All turkey breeding flocks in production are tested and classified as U.S. M. Meleagridis Clean or have met equivalent requirements for M. meleagridis (iii) All turkey hatcheries within the State only handle products that are classified as U.S. M. Meleagridis Clean or have met equivalent requirements for M. meleagridis (iv) All shipments of products from turkey breeding flocks other than those classified as U.S. M. Meleagridis Clean, or equivalent, into the State are prohibited; (v) 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 turkey specimens that have been identified as being infected with M. meleagridis; (vi) All reports of M. meleagridis (vii) All turkey breeding flocks found to be infected with M. meleagridis (2) The Service may revoke the State's classification as a U.S. M. Meleagridis Clean State, Turkeys, if any of the conditions described in paragraph (d)(1) of this section are discontinued. The Service will not revoke the State's classification as a U.S. M. Meleagridis Clean State, Turkeys, until it has conducted an investigation and the Official State Agency has been given an opportunity for a hearing in accordance with rules of practice adopted by the Administrator. (Approved by the Office of Management and Budget under control number 0579-0007) [40 FR 1503, Jan. 8, 1975. Redesignated at 44 FR 61586, Oct. 26, 1979, and amended at 45 FR 10316, Feb. 15, 1980; 48 FR 57473, Dec. 30, 1983; 49 FR 19803, May 10, 1984; 54 FR 23957, June 5, 1989; 61 FR 11521, Mar. 21, 1996; 65 FR 8018, Feb. 17, 2000; 67 FR 8469, Feb. 25, 2002; 76 FR 15793, Mar. 22, 2011; 85 FR 62565, Oct. 5, 2020] § 145.45 Terminology and classification; compartments. (a) US H5/H7 AI and ND Clean Compartment. (1) Definition of the compartment. (i) Definition and description of the subpopulation of birds and their health status. (ii) Description of animal identification and traceability processes. (iii) Definition and description of the physical components or establishments of the defined compartment. (A) The physical and spatial factors that separate the compartment from surrounding bird populations and affect the biosecurity status of the compartment. (B) Relevant environmental factors that may affect exposure of the birds to AI and ND. (C) The functional boundary and fencing that are used to control access to the compartment. (D) Facilities and procedures to prevent access by wild birds and to provide separation from other relevant hosts. (E) The relevant infrastructural factors that may affect exposure to AI and ND, including the construction and design of buildings or physical components, cleaning and disinfection of buildings and physical components between production groups with quality assurance verification, cleaning and disinfection of equipment, and introduction of equipment or material into the compartment. (iv) Definition and description of the functional relationships between components of the defined compartment. (A) Requirements that company employees and contract growers limit their contact with live birds outside the compartment. (B) An education and training program for company employees and contractors. (C) Standard operating procedures for company employees, contractors, and outside maintenance personnel. (D) Requirements for company employees and non-company personnel who visit any premises within the compartment. (E) Company veterinary infrastructure to ensure flock monitoring and disease diagnosis and control measures. (F) Policies for management of vehicles and equipment used within the compartment to connect the various premises. (G) Farm site requirements (location, layout, and construction). (H) Pest management program. (I) Cleaning and disinfection process. (J) Requirements for litter and dead bird removal and/or disposal. (v) Description of other factors important for maintaining the compartment. (vi) Approval or denial. (2) Company activities for maintenance of the compartment. (ii) Veterinary staff from the Official State Agency and NPIP staff will work in partnership with licensed, accredited veterinarians to train and certify auditors through Service-approved workshops. The trained auditors will conduct biosecurity and operational audits at least once every 2 years to ensure the integrity of the compartment. These audits will include evaluation of the critical control points and standard operating practices within the compartment, verification of the health status of the flock(s) contained within the compartment, and examination of the biosecurity and management system of the integrated components of the compartment. (iii) In addition, the company must demonstrate compliance with paragraph (a)(1) of this section for remaining in the U.S. H5/H7 Avian Influenza and ND Clean classifications, surveillance for H5/H7 AI and ND within the compartment, and conducting tests in State or Federal laboratories or in NPIP authorized laboratories. Accredited veterinarians are responsible for the enforcement of active and passive surveillance of H5/H7 AI and ND in primary breeder flocks. Baseline health status must be maintained for all flocks or subpopulations within the compartment, indicating the dates and negative results of all avian influenza and ND surveillance and monitoring testing, the dates and history of last disease occurrence (if any), the number of outbreaks, and the methods of disease control that were applied. (iv) Documentation will be maintained in the company's database and will be verified as required by the Service and/or the Official State Agency. (3) Service and Official State Agency activities for maintenance of the compartment. (i) Oversight of the establishment and management of compartments; (ii) Establishment of effective partnerships between the Service, the Plan, and the primary breeder industry; (iii) Approval or denial of classification of compartments as U.S. H5/H7 Avian Influenza and ND Clean Compartments under paragraph (a)(1) of this section; (iv) Official certification of the health status of the compartment, and commodities that may be traded from it through participation in the Plan for avian diseases, including the U.S. H5/H7 Avian Influenza Clean program as described in § 145.43(g) and ND Clean program as described in § 145.43(h) and diagnostic surveillance for H5/H7 low pathogenicity AI as described in § 145.15; (v) Conducting audits of compartments at least once every 2 years to: (A) Confirm that the primary breeding company's establishments are epidemiologically distinct and pathways for the introduction of disease into the compartment are closed through routine operational procedures; and (B) Evaluate and assess the management and husbandry practices relating to biosecurity to determine whether they are in compliance with hygiene and biosecurity procedures for poultry primary breeding flocks and hatcheries in accordance with part 147 of this subchapter; (vi) Providing, upon request, model plans for management and husbandry practices relating to biosecurity in accordance with part 147 of this subchapter, risk evaluations in conjunction with the primary breeder industry (including disease surveillance such as VS Form 9-4, “Summary of Breeding Flock Participation”), and diagnostic capability summaries and systems for initial State response and containment plans in accordance with § 56.10 of this chapter; and (vii) Publicizing and sharing compartment information with international trading partners, upon request, to establish approval and recognition of the compartment, including timeliness and accuracy of disease reporting and surveillance measures as described in §§ 145.15 and 145.43(g) and (h). (4) Emergency response and notification. (b) [Reserved] (Approved by the Office of Management and Budget under control number 0579-0007) [79 FR 38757, July 9, 2014, as amended at 83 FR 28352, June 19, 2018; 85 FR 62566, Oct. 5, 2020; 90 FR 46747, Sept. 30, 2025] Subpart E—Special Provisions for Hobbyist and Exhibition Poultry, and Raised-for-Release Waterfowl Breeding Flocks and Products § 145.51 Definitions. Except where the context otherwise requires, for the purposes of this subpart the following terms shall be construed, respectively, to mean: Exhibition Poultry. Hobbyist poultry. Raised-for-release waterfowl. [36 FR 23112, Dec. 3, 1971. Redesignated at 44 FR 61586, Oct. 26, 1979, and amended at 59 FR 12799, Mar. 18, 1994; 85 FR 62566, Oct. 5, 2020] § 145.52 Participation. Participating flocks of hobbyist and exhibition poultry, raised-for-release waterfowl, and the eggs, chicks, started, and mature poultry produced from them shall comply with the applicable general provisions of subpart A of this part and the special provisions of this subpart. The special provisions that apply to meat-type waterfowl flocks are found in subpart I of this part. The special provisions that apply to game bird flocks are found in subpart J of this part. (a) Started poultry shall lose their identity under Plan terminology when not maintained by Plan participants under the conditions prescribed in § 145.5(a). (b) Hatching eggs produced by primary breeding flocks shall be fumigated or otherwise sanitized in accordance with part 147 of this subchapter. (c) It is recommended that waterfowl flocks and gallinaceous flocks be kept separate. (d) Subject to the approval of the Service and the Official State Agencies in the importing and exporting States, participating flocks may report poultry sales to importing States by using either VS Form 9-3, “Report of Sales of Hatching Eggs, Chicks, and Poults,” or by using a hatchery invoice form (9-3I) approved by the Official State Agency and the Service to identify poultry sales to clients. If the selling hatchery uses the 9-3I form, the following information must be included on the form: (1) The form number “9-3I”, printed or stamped on the invoice; (2) The hatchery name and address; (3) The date of shipment; (4) The hatchery invoice number; (5) The purchaser name and address; (6) The quantity of products sold; (7) The NPIP hatchery approval number of the shipping hatchery; (8) Identification of the products by bird variety or by NPIP stock code as listed in the NPIP APHIS 91-55-078 appendix; and (9) The appropriate NPIP illustrative design in § 145.10. One of the designs in § 145.10(b) or (g) must be used. The following information must be provided in or near the NPIP design: (i) The NPIP State number and NPIP hatchery approval number; and (ii) The NPIP classification for which product is qualified (e.g., U.S. Pullorum-Typhoid Clean). (e) Any nutritive material provided to baby poultry must be free of the avian pathogens that are officially represented in the Plan disease classifications listed in § 145.10. (f) All participating raised-for-release waterfowl flocks, regardless of whether they are breeders or non-breeders, shall be enrolled under this subpart. [36 FR 23112, Dec. 3, 1971. Redesignated at 44 FR 61586, Oct. 26, 1979, and amended at 49 FR 19803, May 10, 1984; 57 FR 57341, Dec. 4, 1992; 61 FR 11521, Mar. 21, 1996; 65 FR 8019, Feb. 17, 2000; 74 FR 14715, Apr. 1, 2009; 76 FR 15793, Mar. 22, 2011; 79 FR 38759, July 9, 2014; 83 FR 28353, June 19, 2018; 85 FR 62566, Oct. 5, 2020] § 145.53 Terminology and classification; flocks and products. Participating flocks, and the eggs, chicks, started, and mature poultry 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. (1) It has been officially blood tested within the past 12 months with either no reactors or reactors that, upon further bacteriological examination conducted in accordance with part 147 of this subchapter, fail to isolate Salmonella Salmonella (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, (3) It is a multiplier breeding flock 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 hatcheries within the State are qualified as “National Plan Hatcheries” or have met equivalent requirements for pullorum-typhoid control under official supervision; (ii) 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, (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, (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) 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; (viii) Discontinuation of any of the conditions or procedures described in paragraphs (b)(3)(i), (ii), (iii), (iv), (v), (vi), and (vii) 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. (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 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 within the past 12 months with either no reactors or reactors that, upon further bacteriological examination conducted in accordance with part 147 of this subchapter, fail to isolate Salmonella Salmonella Provided, And Provided further, (c) U.S. M. Gallisepticum Clean. (i) It is a flock in which all birds or a sample of at least 300 birds has been tested for M. gallisepticum Provided, And provided further, (ii) It is a multiplier breeding flock which originated as U.S. M. Gallisepticum Clean baby poultry from primary breeding flocks and from which a random sample of birds has been tested for M. gallisepticum Provided, (A) At intervals of not more than 90 days, a random sample of serum or egg yolk or a targeted bird sample of the trachea or choanal cleft using appropriate swabs from all the birds in the flock if flock size is less than 30, but at least 30 birds, shall be tested; or (B) At intervals of not more than 30 days, a sample of 25 cull baby poultry produced from the flock shall be subjected to laboratory procedures acceptable to the Official State Agency and approved by the Service, for the detection and recovery of M. gallisepticum. (2) A participant handling U.S. M. Gallisepticum Clean products shall keep these products separate from other products in a manner satisfactory to the Official State Agency: Provided, (3) U.S. M. Gallisepticum Clean baby poultry 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. Mycoplasma synoviae (i) It is a flock in which all birds or a sample of at least 300 birds has been tested for M. synoviae Provided, And provided further, (ii) It is a multiplier breeding flock that originated as U.S. M. Synoviae Clean chicks from primary breeding flocks and from which a random sample of birds has been tested for M. synoviae Provided, (A) At intervals of not more than 90 days, a random sample of serum or egg yolk or a targeted bird sample of the trachea or choanal cleft using appropriate swabs from all the birds in the flock if the flock size is less than 30, but at least 30 birds shall be tested: Provided, (B) At intervals of not more than 30 days, egg yolk testing shall be conducted in accordance with part 147 of this subchapter. (2) A participant handling U.S. M. Synoviae Clean products shall keep those products separate from other products in a manner satisfactory to the Official State Agency: Provided, (3) U.S. M. Synoviae Clean chicks shall be boxed in clean boxes and delivered in trucks that have been cleaned and disinfected as described in in accordance with part 147 of this subchapter. (e) U.S. H5/H7 Avian Influenza Clean. (1) It is a primary breeding flock in which a minimum of 30 birds has been tested negative to the H5 and H7 subtypes of avian influenza as provided in § 145.14(d) when more than 4 months of age; Provided, (i) A sample of at least 30 birds must be tested negative at intervals of 180 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 180-day period. (2) It is a multiplier breeding flock in which a minimum of 30 birds has been tested negative to the H5 and H7 subtypes of avian influenza as provided in § 145.14(d) when more than 4 months of age; Provided, (i) A sample of at least 30 birds must be tested negative at intervals of 180 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 180-day period. (3) A sample of at least 30 birds must be tested and found negative to H5/H7 avian influenza within 21 days prior to movement to slaughter. (f) U.S. Salmonella Monitored. Salmonella (1) Hatcheries must be kept in a sanitary condition as applicable and as outlined in § 145.6 (within the NPIP Program Standards document, Program Standard C applies to hatcheries; alternatives to the program standards may also be approved by the Administrator under § 147.53 of this subchapter). (2) An Authorized Agent shall collect and submit to an authorized laboratory: (i) A minimum of five samples from the hatchery at least every 30 days while in operation. These samples may include: Hatchery debris, swabs from hatchers, setters, hatchery environment, hatchery equipment, sexing tables and belts, meconium, chick box papers, hatching trays, or chick transfer devices. Samples will be examined bacteriologically at an authorized laboratory for Salmonella (ii) Annual environmental samples from each pullet and breeder farm in accordance with this section (within the NPIP Program Standards document, Program Standard B applies to bacteriological examination procedures; alternatives to the program standards may also be approved by the Administrator under § 147.53 of this subchapter). Samples will be examined bacteriologically at an authorized laboratory for Salmonella. (3) If Salmonella (i) A qualified poultry health professional knowledgeable with the operation will be consulted and will: (A) Review test results to evaluate the Salmonella (B) Use the Salmonella Salmonella (ii) [Reserved] (4) To claim products are of the classification in this paragraph (f), all products shall be derived from a farm or hatchery that meets the requirements of the classification. (Approved by the Office of Management and Budget under control number 0579-0007) [36 FR 23112, Dec. 3, 1971. Redesignated at 44 FR 61586, Oct. 26, 1979] Editorial Note: For Federal Register www.govinfo.gov. § 145.54 Terminology and classification; States. (a) U.S. Pullorum-Typhoid Clean State. (i) The State is in compliance with the provisions contained in §§ 145.23(b)(3)(i) through (vii), 145.33(b)(3)(i) through (vii), 145.43(b)(3)(i) through (vi), 145.53(b)(3)(i) through (vii), 145.73(b)(2)(i), 145.83(b)(2)(i), 145.93(b)(3)(i) through (vii), and 145.103(b)(3)(i) through (ix). (ii) No pullorum disease or fowl typhoid is known to exist nor to have existed in hatchery supply flocks within the State during the preceding 12 months: Provided, (2) Discontinuation of any of the conditions described in paragraph (a)(1)(i) of this section, or repeated outbreaks of pullorum or typhoid occur in hatchery supply flocks described in paragraph (a)(1)(ii) of this section, or if an infection spreads from the originating premises, the Service shall have grounds to revoke its determination that the State is entitled to this classification. 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 for a hearing in accordance with rules of practice adopted by the Administrator. [40 FR 1504, Jan. 8, 1975. Redesignated at 44 FR 61586, Oct. 26, 1979, and amended at 54 FR 23957, June 5, 1989; 67 FR 8469, Feb. 25, 2002; 76 FR 15794, Mar. 22, 2011; 85 FR 62567, Oct. 5, 2020] Subpart F—Special Provisions for Ostrich, Emu, Rhea, and Cassowary Breeding Flocks and Products Source: 63 FR 40010, July 27, 1998, unless otherwise noted. § 145.61 Definitions. Except where the context otherwise requires, for the purposes of this subpart the following terms shall be construed, respectively, to mean: Chicks. Ostrich. Struthio camelus, [63 FR 40010, July 27, 1998, as amended at 65 FR 8019, Feb. 17, 2000] § 145.62 Participation. Participating flocks of ostriches, emus, rheas, and cassowaries, and the eggs and chicks produced from them, shall comply with the applicable general provisions of subpart A of this part and the special provisions of this subpart. (a) Started poultry shall lose their identity under Plan terminology when not maintained by Plan participants under the conditions prescribed in § 145.5(a). (b) Hatching eggs produced by primary breeding flocks shall be fumigated or otherwise sanitized in accordance with part 147 of this subchapter. (c) Any nutritive material provided to chicks must be free of the avian pathogens that are officially represented in the Plan disease classifications listed in § 145.10. [63 FR 40010, July 27, 1998, as amended at 65 FR 8019, Feb. 17, 2000; 79 FR 38759, July 9, 2014] § 145.63 Terminology and classification; flocks and products. Participating flocks, and the eggs and baby poultry produced from them, that have met the respective requirements specified in this section may be designated by the following terms and their corresponding designs illustrated in § 145.10. (a) U.S. Pullorum-Typhoid Clean. (1) It has been officially blood tested within the past 12 months with either no reactors or reactors that, upon further bacteriological examination conducted in accordance with part 147 of this subchapter, fail to isolate Salmonella Salmonella (2) It is a breeding flock that meets one of the following criteria: (i)(A) It is a multiplier or primary breeding flock of fewer than 300 birds in which a sample of 10 percent of the birds in a flock or at least 1 bird from each pen, whichever is more, has been officially tested for pullorum-typhoid within the past 12 months with either no reactors or reactors that, upon further bacteriological examination conducted in accordance with part 147 of this subchapter, fail to isolate Salmonella Salmonella (B) It is a multiplier or primary breeding flock of 300 birds or more in which a sample of a minimum of 30 birds has been officially tested for pullorum-typhoid within the past 12 months with either no reactors or reactors that, upon further bacteriological examination conducted in accordance with part 147 of this subchapter, fail to isolate Salmonella Salmonella (ii) It is a flock that has already been designated U.S. Pullorum-Typhoid Clean and uses a subsequent bacteriological examination monitoring program of hatcher debris or eggs for ostriches, emus, rheas, or cassowaries acceptable to the Official State Agency and approved by the Service in lieu of annual blood testing. (iii) It is a multiplier breeding flock located in a State that has been deemed to be a U.S. Pullorum-Typhoid Clean State for the past 3 years, and during which time no isolation of pullorum or typhoid has been made that can be traced to a source in that State, that uses a bacteriological examination monitoring program of hatcher debris or eggs or a serological examination monitoring program acceptable to the Official State Agency and approved by the Service in lieu of annual blood testing. (b) U.S. Avian Influenza Clean. (1) It is a primary breeding flock in which 10 percent of the flock, up to a maximum of 30 birds, has been tested negative for type A influenza virus with all pens represented equally and when the tested birds are more than 4 months of age. Positive samples shall be further tested by an authorized laboratory. To retain this classification: (i) A sample of at least 30 birds must be tested negative at intervals of 180 days, or (ii) A sample of less than 10 percent of the birds, up to a maximum of 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 180-day period. (2) It is a multiplier breeding flock in which a minimum of 30 birds has been tested negative to type A influenza virus with all pens represented equally and when the tested birds are more than 4 months of age. Positive samples shall be further tested by an authorized laboratory. To retain this classification: (i) A sample of at least 30 birds must be tested negative at intervals of 180 days, or (ii) A sample of at least 10 percent of birds from each pen with all pens being represented must be tested negative at intervals of 180 days; or (iii) A sample of less than 10 percent of the birds may be tested, and found to be negative, at any one time if all pens are equally represented and a total of 10 percent of the birds are tested within each 180-day period. [63 FR 40010, July 27, 1998, as amended at 65 FR 8019, Feb. 17, 2000; 72 FR 1420, Jan. 12, 2007; 74 FR 14715, Apr. 1, 2009; 83 FR 28353, June 19, 2018] Subpart G—Special Provisions for Primary Egg-Type Chicken Breeding Flocks and Products Source: 72 FR 1420, Jan. 12, 2007, unless otherwise noted. § 145.71 Definitions. Except where the context otherwise requires, for the purposes of this subpart the following terms shall be construed, respectively, to mean: Chicks. Primary egg-type chicken breeding flocks. Started chickens. § 145.72 Participation. Participating flocks of primary egg-type chickens, and the eggs and chicks produced from them, shall comply with the applicable general provisions of subpart A of this part and the special provisions of this subpart G. (a) Started chickens shall lose their identity under Plan terminology when not maintained by Plan participants under the conditions prescribed in § 145.5(a). (b) Hatching eggs produced by primary breeding flocks should be nest clean. They may be fumigated in accordance with part 147 of this subchapter or otherwise sanitized. (c) Any nutritive material provided to chicks must be free of the avian pathogens that are officially represented in the Plan disease classifications listed in § 145.10. [72 FR 1420, Jan. 12, 2007, as amended at 79 FR 38759, July 9, 2014] § 145.73 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. Provided, (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 Salmonella Salmonella (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 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, (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 Salmonella Salmonella (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, (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), 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 Salmonella Salmonella Provided, (c) U.S. M. Gallisepticum Clean. M. gallisepticum (i) It is a flock in which all birds or a sample of at least 300 birds has been tested for M. gallisepticum Provided, And provided further, (ii) [Reserved] (2) A participant handling U.S. M. Gallisepticum Clean products shall 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. (d) U.S. Salmonella Enteritidis Clean. Salmonella enteritidis. (1) A flock and the hatching eggs and chicks produced from it which have met the following requirements as determined by the Official State Agency: (i) The flock originated from a U.S. S. Enteritidis Clean flock, or meconium from the chick boxes and a sample of chicks that died within 7 days after hatching are examined bacteriologically for salmonella at an authorized laboratory. Cultures from serogroup D positive samples shall be serotyped. (ii) All feed fed to the flock shall meet the following requirements: (A) Pelletized feed shall contain either no animal protein or only animal protein products produced under the Animal Protein Products Industry (APPI) Salmonella (B) Mash feed may contain no animal protein other than an APPI animal protein product supplement manufactured in pellet form and crumbled: Provided, (iii) Feed shall be stored and transported in such a manner as to prevent possible contamination; (iv) The flock is maintained in accordance with part 147 of this subchapter with respect to flock sanitation, cleaning and disinfection, and Salmonella isolation, sanitation, and management. Rodents and other pests should be effectively controlled; (v) Environmental samples shall be collected from the flock by an Authorized Agent, in accordance with part 147 of this subchapter, when the flock is 2 to 4 weeks of age. The samples shall be examined bacteriologically for group D salmonella at an authorized laboratory. Cultures from positive samples shall be serotyped. The Authorized Agent shall also collect samples every 30 days after the first sample has been collected. (vi) Hatching eggs are collected as quickly as possible and are handled as described in § 147.22 of this subchapter and are sanitized or fumigated (see § 147.25 of this subchapter). (vii) Hatching eggs produced by the flock are incubated in a hatchery whose sanitation is maintained in accordance with part 147 of this subchapter and sanitized either by a procedure approved by the Official State Agency or in accordance with part 147 of this subchapter. (2) A flock shall not be eligible for this classification if Salmonella enteritidis enteritidis (3) In order for a hatchery to sell products of this classification, 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. 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. (e) U.S. M. Synoviae Clean. M. synoviae (i) It is a flock in which a minimum of 300 birds has been tested for M. synoviae Provided, And provided further, (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. (f) U.S. Avian Influenza Clean. (1) It is a primary breeding flock in which a minimum of 30 birds have been tested and found negative for avian influenza 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) A sample of at least 11 birds must be tested and found negative for avian influenza within 21 days prior to movement to slaughter. (g) U.S. Salmonella Monitored. (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) The flock is maintained in accordance with part 147 of this subchapter with respect to flock sanitation, cleaning and disinfection, and Salmonella isolation, sanitation, and management. (ii) Measures shall be implemented to control Salmonella challenge through feed, feed storage, and feed transport. (iii) 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. (iv) An Authorized Agent shall take environmental samples from the hatchery every 30 days; i.e., (v) 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. Owners of flocks shall report the presence or absence of Salmonella in their flocks on a monthly basis to the Official State Agency. (vi) Owners of flocks may vaccinate with a paratyphoid vaccine: Provided, (vii) Any flock entering the production period that is in compliance with all the requirements of this paragraph (g) 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 four separate collection dates over a minimum of a 2-week period. Sampling and testing must be performed as described in paragraph (g)(1)(vi) 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 (g)(1)(i) through (vii) 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. (h) U.S. Newcastle Disease Clean. (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 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 (ii) 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 0579-0007) [72 FR 1420, Jan. 12, 2007, as amended at 76 FR 15794, Mar. 22, 2011; 79 FR 38759, July 9, 2014; 83 FR 28353, June 19, 2018; 85 FR 62567, Oct. 5, 2020; 90 FR 46747, Sept. 30, 2025] § 145.74 Terminology and classification; compartments. (a) U.S. Avian Influenza and Newcastle Disease Clean Compartment. (1) Definition of the compartment. (i) Definition and description of the subpopulation of birds and their health status. (ii) Description of animal identification and traceability processes. (iii) Definition and description of the physical components or establishments of the defined compartment. (A) The physical and spatial factors that separate the compartment from surrounding bird populations and affect the biosecurity status of the compartment. (B) Relevant environmental factors that may affect exposure of the birds to AI and ND. (C) The functional boundary and fencing that are used to control access to the compartment. (D) Facilities and procedures to prevent access by wild birds and to provide separation from other relevant hosts. (E) The relevant infrastructural factors that may affect exposure to AI and ND, including the construction and design of buildings or physical components, cleaning and disinfection of buildings and physical components between production groups with quality assurance verification, cleaning and disinfection of equipment, and introduction of equipment or material into the compartment. (iv) Definition and description of the functional relationships between components of the defined compartment. (A) Requirements that company employees and contract growers limit their contact with live birds outside the compartment. (B) An education and training program for company employees and contractors. (C) Standard operating procedures for company employees, contractors, and outside maintenance personnel. (D) Requirements for company employees and non-company personnel who visit any premises within the compartment. (E) Company veterinary infrastructure to ensure flock monitoring and disease diagnosis and control measures. (F) Policies for management of vehicles and equipment used within the compartment to connect the various premises. (G) Farm site requirements (location, layout, and construction). (H) Pest management program. (I) Cleaning and disinfection process. (J) Requirements for litter and dead bird removal and/or disposal. (v) Description of other factors important for maintaining the compartment. (vi) Approval or denial. (2) Company activities for maintenance of the compartment. (ii) Veterinary staff from the Official State Agency and NPIP staff will work in partnership with licensed, accredited veterinarians to train and certify auditors through Service-approved workshops. The trained auditors will conduct biosecurity and operational audits at least once every 2 years to ensure the integrity of the compartment. These audits will include evaluation of the critical control points and standard operating practices within the compartment, verification of the health status of the flock(s) contained within the compartment, and examination of the biosecurity and management system of the integrated components of the compartment. (iii) In addition, the company must demonstrate compliance with paragraph (a)(1) of this section for remaining in the U.S. Avian Influenza and ND Clean classifications, surveillance for H5/H7 AI and ND within the compartment, and conducting tests in State or Federal laboratories or in NPIP authorized laboratories. Accredited veterinarians are responsible for the enforcement of active and passive surveillance of H5/H7 AI and ND in primary breeder flocks. Baseline health status must be maintained for all flocks or subpopulations within the compartment, indicating the dates and negative results of all avian influenza and ND surveillance and monitoring testing, the dates and history of last disease occurrence (if any), the number of outbreaks, and the methods of disease control that were applied. (iv) Documentation will be maintained in the company's database and will be verified as required by the Service and/or the Official State Agency. (3) Service and Official State Agency activities for maintenance of the compartment. (i) Oversight of the establishment and management of compartments; (ii) Establishment of effective partnerships between the Service, the Plan, and the primary breeder industry; (iii) Approval or denial of classification of compartments as U.S. Avian Influenza and ND Clean Compartments under paragraph (a)(1) of this section; (iv) Official certification of the health status of the compartment, and commodities that may be traded from it through participation in the Plan for avian diseases, including the U.S. Avian Influenza Clean program as described in § 145.73(f) and ND Clean program as described in § 145.73(h) and diagnostic surveillance for H5/H7 low pathogenicity AI as described in § 145.15; (v) Conducting audits of compartments at least once every 2 years to: (A) Confirm that the primary breeding company's establishments are epidemiologically distinct and pathways for the introduction of disease into the compartment are closed through routine operational procedures; and (B) Evaluate and assess the management and husbandry practices relating to biosecurity to determine whether they are in compliance with hygiene and biosecurity procedures for poultry primary breeding flocks and hatcheries in accordance with part 147 of this subchapter; (vi) Providing, upon request, model plans for management and husbandry practices relating to biosecurity in accordance with part 147 of this subchapter, risk evaluations in conjunction with the primary breeder industry (including disease surveillance such as VS Form 9-4, “Summary of Breeding Flock Participation”), and diagnostic capability summaries and systems for initial State response and containment plans in accordance with § 56.10 of this chapter; and (vii) Publicizing and sharing compartment information with international trading partners, upon request, to establish approval and recognition of the compartment, including timeliness and accuracy of disease reporting and surveillance measures as described in §§ 145.15, 145.73(f), and 145.73(h). (4) Emergency response and notification. (b) [Reserved] (Approved by the Office of Management and Budget under control number 0579-0007) [79 FR 38760, July 9, 2014, as amended at 83 FR 28354, June 19, 2018; 85 FR 62567, Oct. 5, 2020; 90 FR 46747, Sept. 30, 2025] Subpart H—Special Provisions for Primary Meat-Type Chicken Breeding Flocks and Products Source: 72 FR 1422, Jan. 12, 2007, unless otherwise noted. § 145.81 Definitions. Except where the context otherwise requires, for the purposes of this subpart the following terms shall be construed, respectively, to mean: Chicks. Primary meat-type chicken breeding flocks. Started chickens. § 145.82 Participation. Participating flocks of primary meat-type chickens, and the eggs and chicks produced from them, shall comply with the applicable general provisions of subpart A of this part and the special provisions of this subpart H. (a) Started chickens shall lose their identity under Plan terminology when not maintained by Plan participants under the conditions prescribed in § 145.5(a). (b) Hatching eggs produced by primary breeding flocks should be nest clean. They may be fumigated in accordance with part 147 of this subchapter or otherwise sanitized. (c) Any nutritive material provided to chicks must be free of the avian pathogens that are officially represented in the Plan disease classifications listed in § 145.10. (d) Poultry must be protected from vectors known to be in the wild and thus must be housed in enclosed structures during brooding, rearing, grow-out, or laying periods with no intentional access to the outdoors, creatures found in the wild, or raised on open range or pasture, or be provided with untreated open source water such as that directly from a pond, stream, or spring that wild birds or vermin have access to for usage for drinking water, as a cooling agent, or during a wash down/clean out process. [72 FR 1422, Jan. 12, 2007, as amended at 79 FR 38762, July 9, 2014; 83 FR 28354, June 19, 2018] § 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. Provided, (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 Salmonella Salmonella (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, (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 Salmonella Salmonella (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, (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 Salmonella Salmonella Provided, (c) U.S. M. Gallisepticum Clean. M. gallisepticum (i) It is a flock in which all birds or a sample of at least 300 birds has been tested for M. gallisepticum Provided, (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. M. synoviae (i) It is a flock in which all birds or a sample of at least 300 birds has been tested for M. synoviae Provided, (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. Salmonella Enteritidis Clean. 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 Salmonella (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 enteritidis (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 (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 Salmonella (C) One hundred percent of blood samples from the birds moved to the clean premises are tested negative for Salmonella Salmonella. Salmonella, (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 Salmonella (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. Salmonella Salmonella (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 (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. Salmonella (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 Salmonella Salmonella (v) Owners of flocks may vaccinate with a paratyphoid vaccine: Provided, (vi) Any flock entering the production period that is in compliance with all the requirements of § 145.83(f) with no history of Salmonella Salmonella Salmonella Salmonella Salmonella (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. (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. (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 in § 145.14 at intervals of 90 days or 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 (ii) 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 0579-0007) [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; 90 FR 46747, Sept. 30, 2025] § 145.84 Terminology and classification; compartments. (a) U.S. Avian Influenza and Newcastle Disease Clean Compartment. (1) Definition of the compartment. (i) Definition and description of the subpopulation of birds and their health status. (ii) Description of animal identification and traceability processes. (iii) Definition and description of the physical components or establishments of the defined compartment. (A) The physical and spatial factors that separate the compartment from surrounding bird populations and affect the biosecurity status of the compartment. (B) Relevant environmental factors that may affect exposure of the birds to AI and ND. (C) The functional boundary and fencing that are used to control access to the compartment. (D) Facilities and procedures to prevent access by wild birds and to provide separation from other relevant hosts. (E) The relevant infrastructural factors that may affect exposure to AI and ND, including the construction and design of buildings or physical components, cleaning and disinfection of buildings and physical components between production groups with quality assurance verification, cleaning and disinfection of equipment, and introduction of equipment or material into the compartment. (iv) Definition and description of the functional relationships between components of the defined compartment. (A) Requirements that company employees and contract growers limit their contact with live birds outside the compartment. (B) An education and training program for company employees and contractors. (C) Standard operating procedures for company employees, contractors, and outside maintenance personnel. (D) Requirements for company employees and non-company personnel who visit any premises within the compartment. (E) Company veterinary infrastructure to ensure flock monitoring and disease diagnosis and control measures. (F) Policies for management of vehicles and equipment used within the compartment to connect the various premises. (G) Farm site requirements (location, layout, and construction). (H) Pest management program. (I) Cleaning and disinfection process. (J) Requirements for litter and dead bird removal and/or disposal. (v) Description of other factors important for maintaining the compartment. (vi) Approval or denial. (2) Company activities for maintenance of the compartment. (ii) Veterinary staff from the Official State Agency and NPIP staff will work in partnership with licensed, accredited veterinarians to train and certify auditors through Service-approved workshops. The trained auditors will conduct biosecurity and operational audits at least once every 2 years to ensure the integrity of the compartment. These audits will include evaluation of the critical control points and standard operating practices within the compartment, verification of the health status of the flock(s) contained within the compartment, and examination of the biosecurity and management system of the integrated components of the compartment. (iii) In addition, the company must demonstrate compliance with paragraph (a)(1) of this section for remaining in the U.S. Avian Influenza and ND Clean classifications, surveillance for H5/H7 AI and ND within the compartment, and conducting tests in State or Federal laboratories or in NPIP authorized laboratories. Accredited veterinarians are responsible for the enforcement of active and passive surveillance of H5/H7 AI and ND in primary breeder flocks. Baseline health status must be maintained for all flocks or subpopulations within the compartment, indicating the dates and negative results of all avian influenza and ND surveillance and monitoring testing, the dates and history of last disease occurrence (if any), the number of outbreaks, and the methods of disease control that were applied. (iv) Documentation will be maintained in the company's database and will be verified as required by the Service and/or the Official State Agency. (3) Service and Official State Agency activities for maintenance of the compartment. (i) Oversight of the establishment and management of compartments; (ii) Establishment of effective partnerships between the Service, the Plan, and the primary breeder industry; (iii) Approval or denial of classification of compartments as U.S. Avian Influenza Clean and/or ND Clean Compartments under paragraph (a)(1) of this section; (iv) Official certification of the health status of the compartment, and commodities that may be traded from it through participation in the Plan for avian diseases, including the U.S. Avian Influenza Clean program as described in § 145.83(g) and ND Clean program as described in § 145.83(h) and diagnostic surveillance for H5/H7 low pathogenicity AI as described in § 145.15; (v) Conducting audits of compartments at least once every 2 years to: (A) Confirm that the primary breeding company's establishments are epidemiologically distinct and pathways for the introduction of disease into the compartment are closed through routine operational procedures; and (B) Evaluate and assess the management and husbandry practices relating to biosecurity to determine whether they are in compliance with hygiene and biosecurity procedures for poultry primary breeding flocks and hatcheries in accordance with part 147 of this subchapter; (vi) Providing, upon request, model plans for management and husbandry practices relating to biosecurity in accordance with part 147 of this subchapter, risk evaluations in conjunction with the primary breeder industry (including disease surveillance such as VS Form 9-4, “Summary of Breeding Flock Participation”), and diagnostic capability summaries and systems for initial State response and containment plans in accordance with § 56.10 of this chapter; and (vii) Publicizing and sharing compartment information with international trading partners, upon request, to establish approval and recognition of the compartment, including timeliness and accuracy of disease reporting and surveillance measures as described in §§ 145.15 and 145.83(g) and (h). (4) Emergency response and notification. (b) [Reserved] (Approved by the Office of Management and Budget under control number 0579-0007) [79 FR 38763, July 9, 2014, as amended at 83 FR 28354, June 19, 2018; 85 FR 62568, Oct. 5, 2020; 90 FR 46747, Sept. 30, 2025] Subpart I—Special Provisions for Meat-Type Waterfowl Breeding Flocks and Products Source: 76 FR 15794, Mar. 22, 2011, unless otherwise noted. § 145.91 Definitions. Except where the context otherwise requires, for the purposes of this subpart the following term shall be construed to mean: Meat-type waterfowl breeding flocks. § 145.92 Participation. Participating flocks of meat-type waterfowl and the eggs and baby poultry produced from them shall comply with the applicable general provisions of subpart A of this part and the special provisions of this subpart I. (a) Started poultry shall lose their identity under Plan terminology when not maintained by Plan participants under the conditions prescribed in § 145.5(a). (b) Hatching eggs produced by primary and multiplier breeding flocks should be nest clean. They may be fumigated in accordance with part 147 of this subchapter or otherwise sanitized. (c) Any nutritive material provided to baby poultry must be free of the avian pathogens that are officially represented in the Plan disease classifications listed in § 145.10. [76 FR 15794, Mar. 22, 2011, as amended at 79 FR 38764, July 9, 2014; 81 FR 53250, Aug. 12, 2016] § 145.93 Terminology and classification; flocks and products. Participating flocks, and the eggs and baby poultry produced from them, that 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. See (1) It has been officially blood tested within the past 12 months with either no reactors or reactors that, upon further bacteriological examination conducted in accordance with part 147 of this subchapter, fail to isolate Salmonella Salmonella (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 Salmonella Salmonella (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, (3) It is a multiplier breeding flock 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 hatcheries within the State are qualified as “National Plan Hatcheries” or have met equivalent requirements for pullorum-typhoid control under official supervision; (ii) 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, (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 Salmonella Salmonella (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, (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) 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; (viii) Discontinuation of any of the conditions or procedures described in paragraphs (b)(3)(i), (ii), (iii), (iv), (v), (vi), and (vii) 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. (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 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 provisions of paragraph (b)(3) 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 within the past 12 months with either no reactors or reactors that, upon further bacteriological examination conducted in accordance with part 147 of this subchapter, fail to isolate Salmonella Salmonella Provided, (c) U.S. H5/H7 Avian Influenza Clean. (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. To retain this classification: (i) A sample of at least 30 birds must be tested and found to be 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 to the H5/H7 subtypes of avian influenza as provided in § 145.14(d) 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 180 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 180-day period. (3) A sample of at least 11 birds must be tested and found negative to H5/H7 avian influenza within 21 days prior to movement to slaughter. (d) U.S. Salmonella Monitored. Salmonella (1) A flock and the hatching eggs and day-old waterfowl produced from it must meet the following requirements, as determined by the Official State Agency, to be eligible for this classification: (i) The flock is maintained in compliance with isolation, sanitation, and management procedures for Salmonella in accordance with part 147 of this subchapter. (ii) If feed contains animal protein, the protein products must have been heated throughout to a minimum temperature of 190 °F or above, or to a minimum temperature of 165 °F for at least 20 minutes, or to a minimum temperature of 184 °F under 70 lbs. pressure during the manufacturing process. (iii) Feed shall be stored and transported in a manner that prevents contamination. (iv) Waterfowl 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. (v) An Authorized Agent shall take environmental samples from the hatchery every 30 days, i.e., meconium or box liner paper. An authorized laboratory for Salmonella shall examine the samples bacteriologically. (vi) 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. (vii) Flocks may be vaccinated with a paratyphoid vaccine: Provided, (2) The Official State Agency may monitor the effectiveness of the egg sanitation practices in accordance with part 147 of this subchapter. (3) To claim products are of this classification, all products shall be derived from a hatchery and flock that 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. [76 FR 15794, Mar. 22, 2011, as amended at 79 FR 38764, July 9, 2014; 81 FR 53250, Aug. 12, 2016; 83 FR 28355, June 19, 2018] § 145.94 Terminology and classification; States. (a) U.S. Pullorum-Typhoid Clean State. (i) The State is in compliance with the provisions contained in §§ 145.23(b)(3)(i) through (vii), 145.33(b)(3)(i) through (vii), 145.43(b)(3)(i) through (vi), 145.53(b)(3)(i) through (vii), 145.73(b)(2)(i), 145.83(b)(2)(i), 145.93(b)(3)(i) through (vii), and 145.103(b)(3)(i) through (ix). (ii) No pullorum disease or fowl typhoid is known to exist nor to have existed in hatchery supply flocks within the State during the preceding 12 months: Provided, (2) Discontinuation of any of the conditions described in paragraph (a)(1)(i) of this section, or repeated outbreaks of pullorum or typhoid occur in hatchery supply flocks described in paragraph (a)(1)(ii) of this section, or if an infection spreads from the originating premises, the Service shall have grounds to revoke its determination that the State is entitled to this classification. 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 for a hearing in accordance with rules of practice adopted by the Administrator. (b) [Reserved] [76 FR 15794, Mar. 22, 2011, as amended at 85 FR 62568, Oct. 5, 2020] Subpart J—Special Provisions for Egg/Meat-Type Game Bird and Raised-for-Release Game Bird Breeding Flocks and Products Source: 85 FR 62568, Oct. 5, 2020, unless otherwise noted. § 145.101 Definitions. Except where the context otherwise requires, for the purposes of this subpart the following terms shall be construed, respectively, to mean: Egg/meat-type bird. Game birds. Raised-for-release bird. § 145.102 Participation. Participating flocks of egg/meat-type game birds, raised-for-release game birds, and the products produced from them shall comply with the applicable general provisions of subpart A of this part and the special provisions of this subpart. Participation is broken into the following categories of operation and products: (a) The categories for operation are: (1) Breeder. (2) Hatchery. (3) Grower. (4) Dealer. (b) The categories for products are: (1) Egg. (2) Chick. (3) Started bird. (4) Mature bird. (c) Products shall lose their identity under Plan terminology when not maintained by Plan participants under the conditions prescribed in § 145.5(a). (d) Hatching eggs produced by breeding flocks shall be nest clean, fumigated, or otherwise sanitized in accordance with part 147 of this subchapter. (e) Under this subpart, gallinaceous flocks and waterfowl flocks may not be raised on the same premises. If they are on the same premises, they must be registered under subpart E of this part. (f) Any nutritive material provided to baby poultry must be free of the avian pathogens that are officially represented in the Plan disease classifications listed in § 145.10. (g) A flock of game birds that are not breeders, but are located on the same premise as game bird breeders, shall be covered under the same NPIP hatchery approval number as long as the appropriate testing requirements have been met. (h) All participating raised-for-release game bird flocks, regardless of whether they are breeders or non-breeders, shall be enrolled under this subpart. (i) A breeder, hatchery, or grower may also be a dealer without being categorized as a dealer. To resell products under the assigned NPIP number and avoid losing NPIP flock classifications, products must be purchased from an NPIP participant with equal or greater classifications or from a flock with equivalent or greater testing requirements under official supervision. (j) Subject to the approval of the Service and the Official State Agencies in the importing and exporting States, participating flocks may report poultry sales to importing States by using either VS Form 9-3, “Report of Sales of Hatching Eggs, Chicks, and Poults,” or by using an invoice form (9-3I) approved by the Official State Agency and the Service to identify poultry sales to clients. If the 9-3I form is used, the following information must be included on the form: (1) The form number “9-3I”, printed or stamped on the invoice; (2) The seller name and address; (3) The date of shipment; (4) The invoice number; (5) The purchaser name and address; (6) The quantity of products sold; (7) Identification of the products by bird variety or by NPIP stock code as listed in the NPIP APHIS 91-55-078 appendix; and (8) The appropriate NPIP illustrative design in § 145.10. One of the designs in § 145.10(b) or (g) must be used. The following information must be provided in or near the NPIP design: (i) The NPIP State number and NPIP approval number; and (ii) The NPIP classification for which product is qualified ( e.g., [85 FR 62568, Oct. 5, 2020, as amended at 90 FR 46747, Sept. 30, 2025] § 145.103 Terminology and classification; flocks and products. Participating flocks, and the eggs, chicks, started, and mature birds 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. (1) It has been officially blood tested within the past 12 months with either no reactors or reactors that, upon further bacteriological examination conducted in accordance with part 147 of this subchapter, fail to isolate Salmonella Salmonella (2) It is a started or mature bird flock that 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 Salmonella Salmonella (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, (3) It is a breeding flock that originated from U.S. Pullorum-Typhoid Clean breeding flocks or from flocks that met equivalent requirements under official supervision, 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 no reactors or reactors that upon bacteriologic examination fail to reveal Pullorum-Typhoid: Provided, And provided further, (i) All hatcheries within the State are qualified as “National Plan Hatcheries” or have met equivalent requirements for pullorum-typhoid control under official supervision; (ii) 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, (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 Salmonella Salmonella (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, (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) 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 (viii) The 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 24 months. (ix) Discontinuation of any of the conditions or procedures described in paragraphs (b)(3)(i) through (viii) 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. (c) U.S. H5/H7 Avian Influenza Clean. (1) It is a flock in which a minimum of 30 birds has been tested negative to the H5 and H7 subtypes of avian influenza as provided in § 145.14(d) when more than 4 months of age. To retain the classification in this paragraph (c): (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) For participants with non-breeding flocks retained for raised-for-release or other purposes on the same premises as a breeding flock, a representative sample of at least 30 birds from the participating premises must be tested negative to the H5 and H7 subtypes of avian influenza as provided in § 145.14(d) when more than 4 months of age, every 90 days. (d) U.S. Salmonella Monitored. Salmonella Salmonella (1) An Authorized Agent shall collect a minimum of five environmental samples, e.g., (2) To claim products are of the classification in this paragraph (d), all products shall be derived from a hatchery that meets the requirements of the classification. (3) The classification in this paragraph (d) may be revoked by the Official State Agency if the participant fails to follow recommended corrective measures. [85 FR 62568, Oct. 5, 2020, as amended at 90 FR 46747, Sept. 30, 2025] § 145.104 Terminology and classification; States. (a) U.S. Pullorum-Typhoid Clean State. (i) The State is in compliance with the provisions contained in §§ 145.23(b)(3)(i) through (vii), 145.33(b)(3)(i) through (vii), 145.43(b)(3)(i) through (vi), 145.53(b)(3)(i) through (vii), 145.73(b)(2)(i), 145.83(b)(2)(i), 145.93(b)(3)(i) through (vii), and 145.103(b)(3)(i) through (ix). (ii) No pullorum disease or fowl typhoid is known to exist nor to have existed in hatchery supply flocks within the State during the preceding 12 months: Provided, (2) If there is discontinuation of any of the conditions described in paragraph (a)(1)(i) of this section, or repeated outbreaks of pullorum or typhoid occur in hatchery supply flocks described in paragraph (a)(1)(ii) of this section, or if an infection spreads from the originating premises, the Service shall have grounds to revoke its determination that the State is entitled to this classification in this paragraph (a). 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 for a hearing in accordance with rules of practice adopted by the Administrator. (b) [Reserved]

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