9 C.F.R. PART 145—NATIONAL POULTRY IMPROVEMENT PLAN
Title 9 - Animals and Animal Products
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.
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. The Administrator, Animal and Plant Health Inspection Service, or any person authorized to act for the Administrator. Affiliated flockowner. A flockowner who is participating in the Plan through an agreement with a participating hatchery. Animal and Plant Health Inspection Service. The Animal and Plant Health Inspection Service of the U.S. Department of Agriculture. Authorized Agent. Any person designated under §145.11(a) to perform functions under this part. Authorized laboratory. A laboratory designated by an Official State Agency, subject to review by the Service, to perform the blood testing and bacteriological examinations provided for in this part. The Service's review will include, but will not necessarily be limited to, checking records, laboratory protocol, check-test proficiency, periodic duplicate samples, and peer review. A satisfactory review will result in the authorized laboratory being recognized by the Service as a nationally approved laboratory qualified to perform the blood testing and bacteriological examinations provided for in this part. Baby poultry. Newly hatched poultry (chicks, poults, ducklings, goslings, keets, etc.). Colon bacilli. For the purpose of this chapter, those organisms which are gram negative, non spore-forming bacilli, which ferment lactose with gas formation, and serve as an index of fecal contamination. Dealer. An individual or business that deals in commerce in hatching eggs, newly-hatched poultry, and started poultry obtained from breeding flocks and hatcheries. This does not include an individual or business that deals in commerce in buying and selling poultry for slaughter only. Department. The U.S. Department of Agriculture. Domesticated. Propagated and maintained under the control of a person. Equivalent or equivalent requirements. Requirements which are equal to the program, conditions, criteria, or classifications with which compared, as determined by the Official State Agency and with the concurrence of the Service. Exposed (Exposure). Contact with birds, equipment, personnel, supplies, or any article infected with, or contaminated by, communicable poultry disease organisms. Flock—(1) As applied to breeding. All poultry of one kind of mating (breed and variety or combination of stocks) and of one classification on one farm; (2) As applied to disease control. All of the poultry on one farm except that, at the discretion of the Official State Agency, any group of poultry which is segregated from another group and has been so segregated for a period of at least 21 days may be considered as a separate flock. Fluff sample. Feathers, shell membrane, and other debris resulting from the hatching of poultry. Fowl typhoid or typhoid. A disease of poultry caused by Salmonella gallinarum. Franchise breeder. A breeder who normally sells products under a specific strain or trade name and who authorizes other hatcheries to produce and sell products under this same strain or trade name. Franchise hatchery. A hatchery which has been authorized by a franchise breeder to produce and sell products under the breeder's strain or trade name. Hatchery. Hatchery equipment on one premises operated or controlled by any person for the production of baby poultry. Independent flock. A flock that produces hatching eggs and that has no ownership affiliation with a specific hatchery. Infected flock. A flock in which an authorized laboratory has discovered one or more birds infected with a communicable poultry disease for which a program has been established under the Plan. Midlay. Approximately 2–3 months after a flock begins to lay or after a molted flock is put back into production. Multiplier breeding flock. A flock that is intended for the production of hatching eggs used for the purpose of producing progeny for commercial egg or meat production or for other nonbreeding purposes. Official State Agency. The State authority recognized by the Department to cooperate in the administration of the Plan. Official supervision—(1) As applied to Plan programs. The direction, inspection, and critical evaluation by the Official State Agency of compliance with the provisions of the Plan; (2) As applied to non-Plan but equivalent State poultry improvement programs. The direction, inspection, and critical evaluation by an officer or agency of a State government, of compliance with a publicly announced State poultry improvement program. Person. A natural person, firm, or corporation. Plan. The provisions of the National Poultry Improvement Plan contained in this part. Poultry. Domesticated fowl, including chickens, turkeys, ostriches, emus, rheas, cassowaries, waterfowl, and game birds, except doves and pigeons, which are bred for the primary purpose of producing eggs or meat. Primary breeding flock. A flock composed of one or more generations that is maintained for the purpose of establishing, continuing, or improving parent lines. Products. Poultry breeding stock and hatching eggs, baby poultry, and started poultry. Program. Management, sanitation, testing, and monitoring procedures which, if complied with, will qualify, and maintain qualification for, designation of a flock, products produced from the flock, or a state by an official Plan classification and illustrative design, as described in §145.10 of this part. Public exhibition. A public show of poultry. Pullorum disease or pullorum. A disease of poultry caused by Salmonella pullorum. Reactor. A bird that has a positive reaction to a test, required or recommended in parts 145 or 147 of this chapter, for any poultry disease for which a program has been established under the Plan. Salmonella. Any bacteria belonging to the genus Salmonella, including the arizona group. Sanitize. To treat with a product which is registered by the Environmental Protection Agency as germicidal, fungicidal, pseudomonocidal, or tuberculocidal, in accordance with the specifications for use as shown on the label of each product. The Official State Agency, with the concurrence of the Service, shall approve each product or procedure according to its specified usage. Service. The Animal and Plant Health Inspection Service, Veterinary Services, of the Department. Serial. The total quantity of completed product which has been thoroughly mixed in a single container and identified by a serial number. Sexual Maturity. The average age at which a species of poultry is biologically capable of reproduction. Started poultry. Young poultry (chicks, pullets, cockerels, capons, poults, ducklings, goslings, keets, etc.) that have been fed and watered and are less than 6 months of age. State. Any State, the District of Columbia, or Puerto Rico. State Inspector. Any person employed or authorized under §145.11(b) to perform functions under this part. Stock. A term used to identify the progeny of a specific breeding combination within a species of poultry. These breeding combinations may include pure strains, strain crosses, breed crosses, or combinations thereof. Strain. Poultry breeding stock bearing a given name produced by a breeder through at least five generations of closed flock breeding. Succeeding flock. A flock brought onto a premises during the 12 months following removal of an infected flock. Suspect flock. A flock shall be considered, for the purposes of the Plan, to be a suspect flock if any evidence exists that it has been exposed to a communicable poultry disease. Trade name or number. A name or number compatible with State and Federal laws and regulations applied to a specified stock or product thereof. [36 FR 23112, Dec. 3, 1971, as amended at 38 FR 13706, May 24, 1973; 41 FR 14256, Apr. 2, 1976; 41 FR 48723, Nov. 5, 1976. Redesignated at 44 FR 61586, Oct. 26, 1979, and amended at 47 FR 21991, May 20, 1982; 49 FR 19802, May 10, 1984; 50 FR 19898, May 13, 1985; 54 FR 23954, June 5, 1989; 57 FR 57340, Dec. 4, 1992; 59 FR 12798, Mar. 18, 1994; 63 FR 40009, July 27, 1998; 65 FR 8016, Feb. 17, 2000; 67 FR 8468, Feb. 25, 2002] (a) The Department cooperates through a Memorandum of Understanding with Official State Agencies in the administration of the Plan. (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(d), 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 follow the laboratory protocols outlined in part 147 of this chapter when determining the status of a participating flock with respect to an official Plan classification. [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] (a) 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. (b) Each participant shall comply with the Plan throughout the operating year of the Official State Agency, or until released by such Agency. (c) A participant in any State shall participate with all of his poultry hatching egg supply flocks and hatchery operations within such State. He 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, 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. (d) 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. (e) Participation in the Plan shall entitle the participant to use the Plan emblem reproduced below: [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] (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. 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. [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] (a) Poultry equipment, and poultry houses and the land in the immediate vicinity thereof, shall be kept in sanitary condition as recommended in §§147.21 and 147.22 (a) and (e) of this chapter. 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, or F 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, That exception may be made at the discretion of the Official State Agency. [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] (a) Hatcheries must be kept in sanitary condition, acceptable to the Official State Agency. The procedures outlined in §§147.22 through 147.25 of this chapter 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 as outlined in §147.24 of this chapter. (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 as outlined in §147.24 of this chapter. (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 as outlined in §147.24 of this chapter. (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 as outlined in §147.24 of this chapter. (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] Dealers in poultry breeding stock, hatching eggs, or baby or started poultry shall comply with all provisions in this part which apply to their operations. (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. 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] Participating flocks, products produced from them, and States which have met the respective requirements specified in part 145 subpart B, C, D, E, or F may be designated by the following terms or illustrative designs: (a) [Reserved] (b) U.S. Pullorum-Typhoid Clean. (See §145.23(b), §145.33(b), §145.43(b), §§145.53(b), and 145.63(a).) (c) U.S. M. Gallisepticum Clean. (See §145.23(c), §145.23(f), §145.33(c), §145.33(f), §145.43(c), and §145.53(c).) (d) U.S. Sanitation Monitored. (See §145.33(d).) (e) U.S. M. Synoviae Clean. (See §145.23(e), §145.23(g), §145.33(e), §145.33(g), §145.43(e), and §145.53(d)). (f) U.S. M. Meleagridis Clean—(See §145.43(d)). (g) U.S. Pullorum-Typhoid Clean State. (See §145.24(a), §145.34(a), §145.44(a), and §145.54(a).) (h) U.S. Pullorum-Typhoid Clean State, Turkeys. (See §145.44(b).) (i) U.S.M. Gallisepticum Clean State, Turkeys. (See §145.44(c).) (j) U.S. M. Gallisepticum Clean State, Meat-Type Chickens. (See §145.34(b).) (k) U.S. Sanitation Monitored, Turkeys. (See §145.43(f).) (l) [Reserved] (m) U.S. S. Enteritidis Clean. (See §145.23(d) and §145.33(h).) (n) U.S. M. Synoviae Clean State, Turkeys. (See §145.44(d).) (o) U.S. Salmonella Monitored. (See §145.33(i).) (p) U.S. M. Gallisepticum Monitored. (See §145.33(j).) (q) U.S. M. Synoviae Monitored. (See §145.33(k).) (r) U.S. Avian Influenza Clean. (See §§145.23(h), 145.33(l), and 145.53(e).) (s) U.S. M. Meleagridis Clean State, Turkeys. (See §145.44(e).) (t) U.S. H5/H7 Avian Influenza Clean. (See §145.43(g).) [38 FR 13706, May 24, 1973, as amended at 40 FR 1500, Jan. 8, 1975; 41 FR 48723, Nov. 5, 1976. Redesignated at 44 FR 61586, Oct. 26, 1979, and amended at 45 FR 10315, Feb. 15, 1980; 47 FR 21991, May 20, 1982; 50 FR 19898, May 13, 1985; 54 FR 23955, June 5, 1989; 57 FR 57341, Dec. 4, 1992; 59 FR 12798, Mar. 18, 1994; 61 FR 11517, Mar. 21, 1996; 62 FR 44068, Aug. 19, 1997; 63 FR 40010, July 27, 1998; 65 FR 8016, Feb. 17, 2000; 67 FR 8468, Feb. 25, 2002; 68 FR 64509, Nov. 14, 2003] (a) The Official State Agency may designate qualified persons as Authorized Agents to do the sample collecting and blood testing provided for in §145.14 and the selecting required for the U.S. Approved classification provided for in §145.53(a). (b) The Official State Agency shall employ or authorize qualified persons as State Inspectors to perform or supervise the performance of the selecting and 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] (a) Each participating hatchery shall be inspected 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 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] 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 means the Administrator, Animal and Plant Health Inspection Service of the U.S. Department of Agriculture or any officer or employee to whom authority has heretofore been delegated or to whom authority may hereafter be delegated to act in his stead. [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] Poultry must be more than 4 months of age when blood tested for an official classification: Provided, That turkey candidates under subpart D of this part may be blood tested at more than 12 weeks of age; game bird candidates under subpart E of this part may be blood 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 blood tested when more than 12 months of age. Blood samples for official tests shall be drawn by an Authorized 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 Agent or State Inspector. For Plan programs in which a representative sample may be tested in lieu of an entire flock, the minimum number tested shall be 30 birds per house, with at least 1 bird taken from each pen and unit in the house. The ratio of male to female birds in representative samples of birds from meat-type chicken, waterfowl, exhibition poultry, and game bird flocks must be the same as the ratio of male to female birds in the flock. In houses containing fewer than 30 birds, all birds in the house must be tested. (a) For Pullorum-Typhoid. (1) The official blood tests for pullorum-typhoid shall be the standard tube agglutination test, the microagglutination test, the enzyme-linked immunosorbent assay test (ELISA), or the rapid serum test for all poultry; and the stained antigen, rapid whole-blood test for all poultry except turkeys. The procedures for conducting official blood tests are set forth in §§147.1, 147.2, 147.3, and 147.5 of this chapter and referenced in footnote 3 of this section or in literature provided by the producer. Only antigens approved by the Department and of the polyvalent type shall be used for the rapid whole-blood and tube agglutination tests. Each serial of tube antigen shall be submitted by the antigen producer to the Department for approval upon manufacture and once a year thereafter as long as antigen from that serial continues to be made available for use. All microtest antigens and enzyme-linked immunosorbent assay reagents shall also be approved by the Department.1 1 The criteria and procedures for Department approval of antigens and reagents may be obtained from the Animal and Plant Health Inspection Service, Veterinary Services, Center for Veterinary Biologics, 510 South 17th Street, Suite 104, Ames, IA 50010–8197. (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 and 145.63) 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. The approved procedure for bacteriological examination is set forth in §147.11 of this chapter. 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 has no pullorum-typhoid reactors. (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 S. pullorum or S. gallinarum organisms are isolated by an authorized laboratory from baby poultry, or from fluff samples produced by hatching eggs, the infected flock shall qualify for participation in the Plan with two consecutive negative results to an official blood test named in paragraph (a)(1) of this section. A succeeding flock must be qualified for participation in the Plan's pullorum-typhoid program with a negative result to an official blood test named in paragraph (a)(1) of this section. Testing to qualify flocks for Plan participation must include the testing of all birds in infected flocks and succeeding flocks for a 12-month period, and shall be performed or physically supervised by a State Inspector; Provided, That at the discretion of the Official State Agency, a sample of at least 500 birds, rather than all birds in the flock, may be tested by the State Inspector if it is agreed upon by the Official State Agency, the flockowner, and the Administrator. If the State Inspector determines that a primary breeding flock has been exposed to S. pullorum or S. gallinarum,2 2 In making determinations of exposure, the State Inspector shall evaluate both evidence proving that exposure occurred and circumstances indicating a high probability of contacts with: infected wild birds; contaminated feed or waste; or birds, equipment, supplies, or persons from or exposed to flocks infected with S. pullorum or S. gallinarum. (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 S. pullorum or S. gallinarum occurred.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 M. gallisepticum and M. synoviae: (1) The official blood tests for M. gallisepticum and M. synoviae shall be the serum plate agglutination test, the tube agglutination test, the hemagglutination inhibition (HI) test, the microhemagglutination inhibition test, the enzyme-linked immunosorbent assay (ELISA) test 3 3 Procedures for the enzyme-linked immunosorbent assay (ELISA) test are set forth in the following publications: 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, Vol. 27, No. 1, pp. 21–35, January-March 1983; and 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, Vol. 27, No. 3, pp. 773–786, July-September 1983; and H.B. Ortmayer and R. Yamamoto, “Mycoplasma Meleagridis Antibody Detection by Enzyme-Linked Immunosorbent Assay (ELISA),” Proceedings, 30th Western Poultry Disease Conference, pp. 63–66, March 1981. (2) The tests shall be conducted using M. gallisepticum or M. synoviae antigens approved by the Department or the Official State Agency and shall be performed in accordance with the recommendations of the producer of the antigen. (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 criteria found in §147.6 of this chapter shall be used in determining the final status of the flock. (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. (c) For M. meleagridis. The official blood tests for M. meleagridis are specified in §145.43(d)(2). (d) For avian influenza. The official blood tests for avian influenza are the agar gel immunodiffusion (AGID) test and the enzyme-linked immunosorbent assay (ELISA). (1) The AGID test must be conducted on all ELISA-positive samples. Positive tests by AGID or ELISA must be further tested by Federal Reference Laboratories. Final judgment may be based upon further sampling or culture results. (2) The tests must be conducted using antigens or test kits approved by the Department and the Official State Agency and must be performed in accordance with the recommendations of the producer or manufacturer. [36 FR 23112, Dec. 3, 1971] Editorial Note: For Except where the context otherwise requires, for the purposes of this subpart the following terms shall be construed, respectively, to mean: Chicks. Newly hatched chickens. Egg type chicken breeding flocks. Flocks that are composed of stock that has been developed for egg production and are maintained for the principal purpose of producing chicks for the ultimate production of eggs for human consumption. Started chickens. Young chickens (chicks, pullets, cockerels, capons) which have been fed and watered and are less than 6 months of age. [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] Participating flocks of 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 primary breeding flocks shall be fumigated (see §147.25 of this chapter) 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] Participating flocks, and the eggs and chicks produced from them, which have met the respective requirements specified in this section may be designated by the following terms and the corresponding designs illustrated in §145.10: (a) [Reserved] (b) U.S. Pullorum-Typhoid Clean. A flock in which freedom from pullorum and typhoid has been demonstrated to the official State agency under the criteria in one of the following paragraphs (b)(1) through (5) of this section: Provided, That a flock qualifying by means of a blood test shall be tested within the past 12 months, except that the retesting of a participating flock which is retained for more than 12 months shall be conducted a minimum of 4 weeks after the induction of molt. (See §145.14 relating to the official blood test where applicable.) (1) It has been officially blood tested with no reactors. (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 either no poultry or a flock not classified as U.S. Pullorum-Typhoid Clean were located the previous year; Provided, That an Authorized Agent must blood test up to 300 birds per flock, as described in §145.14, if the Official State Agency determines that the flock has been exposed to pullorum-typhoid. In making determinations of exposure and setting the number of birds to be blood tested, the Official State Agency shall evaluate the results of any blood tests, described in §145.14(a)(1) that were performed on an unclassified flock located on the premises during the previous year; the origins of the unclassified flock; and the probability of contacts between the flock for which qualification is being sought and (a) infected wild birds, (b) contaminated feed or waste, or (c) birds, equipment, supplies, or personnel from flocks infected with pullorum-typhoid. (3) It is a multiplier breeding flock 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, That if other domesticated fowl, except waterfowl, are maintained on the same premises as the participating flock, freedom from pullorum-typhoid infection shall be demonstrated by an official blood test of each of these fowl; (iii) All shipments of products other than U.S. Pullorum-Typhoid Clean, or equivalent, into the State are prohibited; (iv) All persons performing poultry disease diagnostic services within the State are required to report to the Official State Agency within 48 hours the source of all poultry specimens from which S. pullorum or S. gallinarum is isolated; (v) All reports of any disease outbreak involving a disease covered under the Plan are promptly followed by an investigation by the Official State Agency to determine the origin of the infection; Provided, That if the origin of the infection involves another State, or if there is exposure to poultry in another State from the infected flock, then the National Poultry Improvement Plan will conduct an investigation; (vi) All flocks found to be infected with pullorum or typhoid are quarantined until marketed or destroyed under the supervision of the Official State Agency, or until subsequently blood tested, following the procedure for reacting flocks as contained in §145.14(a)(5), and all birds fail to demonstrate pullorum or typhoid infection; (vii) 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. (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 no reactors: Provided, That a bacteriological examination monitoring program acceptable to the Official State Agency and approved by the Service may be used in lieu of blood testing. (c) U.S. M. Gallisepticum Clean. (1) A flock maintained in compliance with the provisions of §147.26 of this chapter and in which freedom from M. gallisepticum has been demonstrated under the criteria specified in paragraph (c)(1)(i) or (ii) of this section. (i) It is a flock in which all birds or a sample of at least 300 birds has been tested for M. gallisepticum as provided in §145.14(b) when more than 4 months of age: Provided, That to retain this classification, a minimum of 150 birds shall be tested at intervals of not more than 90 days: And provided further, That a sample comprised of less than 150 birds may be tested at any one time, if all pens are equally represented and a total of 150 birds is tested within each 90-day period; or (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 as provided in §145.14(b) when more than 4 months of age: Provided, That to retain this classification, the flock shall be subjected to one of the following procedures: (A) At intervals of not more than 90 days, 75 birds from the flock shall be tested, Provided, that fewer than 75 birds from the flock may be tested at any one time if all pens are equally represented and a total of at least 75 birds from the flock is tested within each 90-day period; or (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; or (C) At intervals of not more than 30 days, egg yolk testing shall be conducted in accordance with §147.8 of this chapter. (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, That U.S. M. Gallisepticum Clean chicks from primary breeding flocks shall be produced in incubators and hatchers in which only eggs from flocks qualified under paragraph (c)(1)(i) of this section are set. (3) U.S. M. Gallisepticum Clean chicks shall be boxed in clean boxes and delivered in trucks that have been cleaned and disinfected as described in §147.24(a) of this chapter. (d) U.S. S. Enteritidis Clean. This classification is intended for egg-type breeders wishing to assure their customers that the hatching eggs and chicks produced are certified free of 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 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 Education/Reduction Program. The protein products must have a minimum moisture content of 14.5 percent and 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. (B) Mash feed may contain no animal protein other than an APPI animal protein product supplement manufactured in pellet form and crumbled: Provided, that mash feed may contain nonpelleted APPI animal protein product supplements if the finished feed is treated with a salmonella control product approved by the Food and Drug Administration. (iii) Feed shall be stored and transported in such a manner as to prevent possible contamination; (iv) The flock is maintained in compliance with §§147.21, 147.24(a), and 147.26 of this chapter. Rodents and other pests should be effectively controlled; (v) Environmental samples shall be collected from the flock by an Authorized Agent, as described in §147.12 of this chapter, 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) If a Salmonella vaccine is used that causes positive reactions with pullorum-typhoid antigen, one of the following options must be utilized: (A) Administer the vaccine after the pullorum-typhoid testing is done as described in paragraph (d)(1)(vii) of this section. (B) If an injectable bacterin or live vaccine that does not spread is used, keep a sample of 350 birds unvaccinated and banded for identification until the flock reaches at least 4 months of age. Following negative serological and bacteriological examinations as described in paragraph (d)(1)(vii) of this section, vaccinate the banded, non-vaccinated birds. (vii) Blood samples from 300 non-vaccinated birds as described in paragraph (d)(1)(vi) of this section shall be tested with either pullorum antigen or by a federally licensed Salmonella enteritidis enzyme-linked immunosorbent assay (ELISA) test when the flock is more than 4 months of age. All birds with positive or inconclusive reactions, up to a maximum of 25 birds, shall be submitted to an authorized laboratory and examined for the presence of group D salmonella, as described in §147.11 of this chapter. Cultures from positive samples shall be serotyped. (viii) Hatching eggs are collected as quickly as possible and are handled as described in §147.22 of this chapter and are sanitized or fumigated (see §147.25 of this chapter). (ix) Hatching eggs produced by the flock are incubated in a hatchery that is in compliance with the recommendations in §§147.23 and 147.24(b) of this chapter, and sanitized either by a procedure approved by the Official State Agency or fumigated (see §147.25 of this chapter). (2) A flock shall not be eligible for this classification if Salmonella enteritidis ser enteritidis (SE) is isolated from a specimen taken from a bird in the flock. Isolation of SE from an environmental or other specimen, as described in paragraph (d)(1)(v) of this section, will require bacteriological examination for SE in an authorized laboratory, as described in §147.11(a) of this chapter, of a random sample of 60 live birds from a flock of 5,000 birds or more, or 30 live birds from a flock with fewer than 5,000 birds. If only one specimen is found positive for SE, the participant may request bacteriological examination of a second sample, equal in size to the first sample, from the flock. If no SE is recovered from any of the specimens in the second sample, the flock will be eligible for the classification. (3) A non-vaccinated flock shall be eligible for this classification if Salmonella enteritidis (S. enteritidis ser Enteritidis) is isolated from an environmental sample collected from the flock in accordance with paragraph (d)(1)(v) of this section: Provided, That testing is conducted in accordance with paragraph (d)(1)(vii) of this section each 30 days and no positive samples are found. (4) In order for a hatchery to sell products of this classification, all products handled shall meet the requirements of the classification. (5) 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. (1) A flock maintained in compliance with the provisions of §147.26 of this chapter and in which freedom from M. synoviae has been demonstrated under the criteria specified in paragraph (e)(1)(i) or (ii) of this section. (i) It is a flock in which a minimum of 300 birds has been tested for M. synoviae as provided in §145.14(b) when more than 4 months of age: Provided, That to retain this classification, a sample of at least 150 birds shall be tested at intervals of not more than 90 days: And provided further, That a sample comprised of less than 150 birds may be tested at any one time if all pens are equally represented and a total of 150 birds is tested within each 90-day period; or (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 as provided in §145.14(b) when more than 4 months of age: Provided, That to retain this classification, the flock shall be subjected to one of the following procedures: (A) At intervals of not more than 90 days, 75 birds from the flock shall be tested: Provided, That fewer than 75 birds from the flock may be tested at any one time if all pens are equally represented and a total of at least 75 birds from the flock is tested within each 90-day period; or (B) At intervals of not more than 30 days, egg yolk testing shall be conducted in accordance with §147.8 of this chapter. (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: Provided, That U.S. M. Synoviae Clean chicks from primary breeding flocks shall be produced in incubators and hatchers in which only eggs from flocks qualified under paragraph (e)(1)(i) or (ii) of this section are set. (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 §147.24(a) of this chapter. (f) U.S. M. Gallisepticum Clean Started Poultry. (1) A flock which originated from U.S. M. Gallisepticum Clean breeding flocks and was hatched in a hatchery approved by the Official State Agency for the production of U.S. M. Gallisepticum Clean chicks. (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 compliance with the provisions of §147.26 of this chapter. (4) The flock's freedom from M. Gallisepticum is demonstrated by a negative blood test, as provided in §145.14(b), of a sample of 75 birds, with a minimum of 50 birds per poultry house, between 15–20 days prior to the flock being moved to laying quarters. (5) Started poultry shall be delivered to and from the farm premises in crates and vehicles which have been cleaned and disinfected as described in §147.24(a) of this chapter. (g) U.S. M. Synoviae Clean Started Poultry. (1) A flock which originated from U.S. M. Synoviae Clean breeding flocks and was hatched in a hatchery approved by the Official State Agency for production of U.S. M. Synoviae Clean chicks. (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 compliance with the provisions of §147.26 of this chapter. (4) The flocks's freedom from M. synoviae is demonstrated by a negative blood test, as provided in §145.14(b), of a sample of 75 birds, with a minimum of 50 birds per poultry house, between 15–20 days prior to the flock being moved to laying quarters. (5) Started poultry shall be delivered to and from the farm premises in crates and vehicles which have been cleaned and disinfected as described in §147.24(a) of this chapter. (h) U.S. Avian Influenza Clean. This program is intended to be the basis from which the breeding-hatchery industry may conduct a program for the prevention and control of avian influenza. It is intended to determine the presence of avian influenza in breeding chickens through routine serological surveillance of each participating breeding flock. A flock and the hatching eggs and chicks produced from it will qualify for this classification when the Official State Agency determines that they have met one of the following requirements: (1) It is a primary breeding flock in which a minimum of 30 birds have been tested negative for antibodies to avian influenza 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. (2) It is a multiplier breeding flock in which a minimum of 30 birds have been tested negative for antibodies 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 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 is tested within each 180-day period. [36 FR 23112, Dec. 3, 1971] Editorial Note: For (a) U.S. Pullorum-Typhoid Clean State. (1) A State will be declared a U.S. Pullorum-Typhoid Clean State when it has been determined by the Service that: (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), and §145.53(b)(3)(i) through (vii). (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, That pullorum disease or fowl typhoid found within the preceding 24 months in waterfowl, exhibition poultry, and game bird breeding flocks will not prevent a State, which is otherwise eligible, from qualifying. (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 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] Except where the context otherwise requires, for the purposes of this subpart the following terms shall be construed, respectively, to mean: Chicks. Newly hatched chickens. Meat type chicken breeding flocks. Flocks that are composed of stock that has been developed for meat production and are maintained for the principal purpose of producing chicks for the ultimate production of meat. Started chickens. Young chickens (chicks, pullets, cockerels, capons) which have been fed and watered and are less than 6 months of age. [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] Participating flocks of 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 primary breeding flocks shall be fumigated (see §147.25 of this chapter) 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] Participating flocks, and the eggs and chicks produced from them, which have met the respective requirements specified in this section may be designated by the following terms and the corresponding designs illustrated in §145.10: (a) [Reserved] (b) U.S. Pullorum-Typhoid Clean. A flock in which freedom from pullorum and typhoid has been demonstrated to the official State agency under the criteria in one of paragraphs (b)(1) through (5) of this section: Provided, That a flock qualifying by means of a blood test shall be tested within the past 12 months, except that the retesting of a participating flock which is retained for more than 12 months shall be conducted a minimum of 4 weeks after the induction of molt. (See §145.14 relating to the official blood test where applicable.) (1) It has been officially blood tested with no reactors. (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 either no poultry or a flock not classified as U.S. Pullorum-Typhoid Clean were located the previous year; Provided, That an Authorized Agent must blood test up to 300 birds per flock, as described in §145.14, if the Official State Agency determines that the flock has been exposed to pullorum-typhoid. In making determinations of exposure and setting the number of birds to be blood tested, the Official State Agency shall evaluate the results of any blood tests, described in §145.14(a)(1), that were performed on an unclassified flock located on the premises during the previous year; the origins of the unclassified flock; and the probability of contacts between the flock for which qualification is being sought and (a) infected wild birds, (b) contaminated feed or waste, or (c) birds, equipment, supplies, or personnel from flocks infected with pullorum-typhoid. (3) It is a multiplier breeding flock 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, That if other domesticated fowl, except waterfowl, are maintained on the same premises as the participating flock, freedom from pullorum-typhoid infection shall be demonstrated by an official blood test of each of these fowl; (iii) All shipments of products other than U.S. Pullorum-Typhoid Clean, or equivalent, into the State are prohibited; (iv) All persons performing poultry disease diagnostic services within the State are required to report to the Official State Agency within 48 hours the source of all poultry specimens from which S. pullorum or S. gallinarum is isolated; (v) All reports of any disease outbreak involving a disease covered under the Plan are promptly followed by an investigation by the Official State Agency to determine the origin of the infection; Provided, That if the origin of the infection involves another State, or if there is exposure to poultry in another State from the infected flock, then the National Poultry Improvement Plan will conduct an investigation; (vi) All flocks found to be infected with pullorum or typhoid are quarantined until marketed or destroyed under the supervision of the Official State Agency, or until subsequently blood tested following the procedure for reacting flocks as contained in §145.14(a)(5), and all birds fail to demonstrate pullorum or typhoid infection; (vii) 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. (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 no reactors: Provided, That a bacteriological examination monitoring program acceptable to the Official State Agency and approved by the Service may be used in lieu of blood testing. (c) U.S. M. Gallisepticum Clean. (1) A flock maintained in compliance with the provisions of §147.26 of this chapter and in which freedom from M. gallisepticum has been demonstrated under the criteria specified in paragraph (c)(1)(i) or (ii) of this section. (i) It is a flock in which all birds or a sample of at least 300 birds has been tested for M. gallisepticum as provided in §145.14(b) when more than 4 months of age: Provided, That to retain this classification, a minimum of 150 birds shall be tested at intervals of not more than 90 days: And provided further, That a sample comprised of less than 150 birds may be tested at any one time, if all pens are equally represented and a total 150 birds is tested within each 90-day period; or (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 as provided in §145.14(b) when more than 4 months of age: Provided, That to retain this classification, the flock shall be subjected to one of the following procedures: (A) At intervals of not more than 90 days, 75 birds from the flock shall be tested, Provided, That fewer than 75 birds from the flock may be tested at any one time if all pens are equally represented and a total of at least 75 birds from the flock is tested within each 90-day period; or (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; or (C) At intervals of not more than 30 days, egg yolk testing shall be conducted in accordance with §147.8 of this chapter. (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 (see §§147.22, 147.23, and 147.24) in a manner satisfactory to the Official State Agency: Provided, That U.S. M. Gallisepticum Clean chicks from primary breeding flocks must be produced in incubators and hatchers in which only eggs from flocks qualified under paragraph (c)(1)(i) of this section are set. (3) U.S. M. Gallisepticum Clean chicks shall be boxed in clean boxes and delivered in trucks that have been cleaned and disinfected as described in §147.24(a) of this chapter. (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 as provided in §145.14(b), or by a polymerase chain reaction (PCR)-based procedure approved by the Department. If fewer than 30 male breeding birds are being added, all the birds shall be tested as described above. The male birds shall be tested no more than 14 days prior to their intended introduction into the flock. If the serologic testing of the birds yields hemagglutination inhibition titers of 1:40 or higher as provided in §145.14(b), or if the PCR testing is positive for M. gallisepticum, the male birds may not be added to the flock and must be either retested or destroyed. (d) U.S. Sanitation Monitored. This program is intended to be the basis from which the breeding-hatching industry may conduct a program for the prevention and control of Salmonellosis. It is intended to reduce the incidence of Salmonella organisms in hatching eggs and chicks through an effective and practical sanitation program at the breeder farm and in the hatchery. This will afford other segments of the poultry industry an opportunity to reduce the incidence of Salmonella in their products. (1) A flock and the hatching eggs and chicks produced from it 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 compliance with §§147.21, 147.24(a), and 147.26 of this chapter; (iii) If pelletized feed contains animal protein, the protein products shall be purchased from participants in the Animal Protein Products Industry (APPI) Salmonella Education/Reduction Program or the Fishmeal Inspection Program of the National Marine Fisheries Service. The protein products must have a minimum moisture content of 14.5 percent and 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; (iv) If mash feed contains animal protein, the protein products shall be purchased from participants in the Animal Protein Products Industry (APPI) Salmonella Education/Reduction Program or the Fishmeal Inspection Program of the National Marine Fisheries Service; (v) Feed shall be stored and transported in such a manner as to prevent possible contamination; (vi) Chicks shall be hatched in a hatchery meeting the requirements of §§147.23 and 147.24(b) of this chapter and sanitized or fumigated (see §147.25 of this chapter); (vii) An Authorized Agent shall take environmental samples, as described in §147.12 of this chapter, from each flock at 4 months of age and every 90 days thereafter. An authorized laboratory for Salmonella shall examine the environmental samples bacteriologically; (viii) Owners of flocks found infected with a paratyphoid Salmonella may vaccinate these flocks with an autogenous bacterin with a potentiating agent.4 4 Preparation and use of this type of vaccine may be regulated by State statutes. (2) The Official State Agency may use the procedures described in §147.14 of this chapter to monitor the effectiveness of the sanitation practices. (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. (1) A flock maintained in compliance with the provisions of §147.26 of this chapter and in which freedom from M. synoviae has been demonstrated under the criteria specified in paragraph (e)(1)(i) or (ii) of this section. (i) It is a flock in which a minimum of 300 birds has been tested for M. synoviae as provided in §145.14(b) when more than 4 months of age: Provided, That to retain this classification, a sample of at least 150 birds shall be tested at intervals of not more than 90 days: And provided further, That a sample comprised of less than 150 birds may be tested at any one time if all pens are equally represented and a total of 150 birds is tested within each 90-day period; or (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 as provided in §145.14(b) when more than 4 months of age: Provided, That to retain this classification, the flock shall be subjected to one of the following procedures: (A) At intervals of not more than 90 days, 75 birds from the flock shall be tested: Provided, That fewer than 75 birds from the flock may be tested at any one time if all pens are equally represented and a total of at least 75 birds from the flock is tested within each 90-day period; or (B) At intervals of not more than 30 days, egg yolk testing shall be conducted in accordance with §147.8 of this chapter. (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: Provided, That U.S. M. Synoviae Clean chicks from primary breeding flocks shall be produced in incubators and hatchers in which only eggs from flocks qualified under paragraph (e)(1)(i) or (ii) of this section are set. (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 §147.24(a) of this chapter. (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 as provided in §145.14(b) or by a polymerase chain reaction (PCR)-based procedure approved by the Department. If fewer than 30 male breeding birds are being added, all the birds shall be tested as described above. The male birds shall be tested no more than 14 days prior to their intended introduction into the flock. If the serologic testing of the birds yields hemagglutination inhibition titers of 1:40 or higher as provided in §145.14(b), or if the PCR testing is positive for M. synoviae, the male birds may not be added to the flock and must be either retested or destroyed. (f) U.S. M. Gallisepticum Clean Started Poultry. (1) A flock which originated from U.S. M. Gallisepticum Clean breeding flocks and was hatched in a hatchery approved by the Official State Agency for the production of U.S. M. Gallisepticum Clean chicks. (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 compliance with the provisions of §147.26 of this chapter. (4) The flock's freedom from M. gallisepticum is demonstrated by a negative blood test, as provided in §145.14(b), of a sample of 75 birds, with a minimum of 50 birds per poultry house, between 15–20 days prior to the flock being moved to laying quarters. (5) Started poultry shall be delivered to and from the farm premises in crates and vehicles which have been cleaned and disinfected as described in §147.24(a) of this chapter. (g) U.S. M. Synoviae Clean Started Poultry. (1) A flock which originated from U.S. M. Synoviae Clean breeding flocks and was hatched in a hatchery approved by the Official State Agency for the production of U.S. M. Synoviae Clean chicks. (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 compliance with the provisions of §147.26 of this chapter. (4) The flock's freedom from M. synoviae is demonstrated by a negative blood test, as provided in §145.14(b), of a sample of 75 birds, with a minimum of 50 birds per poultry house, between 15–20 days prior to the flock being moved to laying quarters. (5) Started poultry shall be delivered to and from the farm premises in crates and vehicles which have been cleaned and disinfected as described in §147.24(a) of this chapter. (h) U.S. S. Enteritidis Clean. This classification is intended for meat-type breeders wishing to assure their customers that the chicks produced are certified free of Salmonella enteritidis. (1) A flock and the hatching eggs and chicks produced from it shall be eligible for this classification if they meet the following requirements, as determined by the Official State Agency: (i) The flock originated from a U.S. S. Enteritidis Clean flock, or one of the following samples has been examined bacteriologically for S. enteritidis at an authorized laboratory and any group D Salmonella samples have been serotyped: (A) A 25-gram sample of meconium from the chicks in the flock collected and cultured as described in §147.12(a)(5) of this chapter; or (B) A sample of chick papers collected and cultured as described in §147.12(c) of this chapter; or (C) A sample of 10 chicks that died within 7 days after hatching. (ii) All feed fed to the flock meets the following requirements: (A) Pelletized feed must have a minimum moisture content of 14.5 percent and must have been heated throughout to a minimum temperature of 190 °F, or to a minimum temperature of 165 °F for at least 20 minutes, or to a minimum temperature of 184 °F under 70 lb pressure during the manufacturing process; (B) Mash feed may contain animal protein if the finished feed is treated with a salmonella control product approved by the Food and Drug Administration. (C) All feed is stored and transported in such a manner as to prevent possible contamination. (iii) The flock is maintained in compliance with §§147.21, 147.24(a), and 147.26 of this chapter. (iv) Environmental samples, as described in §147.12 of this chapter, are collected from the flock by or under the supervision of an Authorized Agent when the flock reaches 4 months of age and every 30 days thereafter. 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. (v) Blood samples from 300 birds from the flock are officially tested with pullorum antigen when the flock is at least 4 months of age. All birds with positive or inconclusive reactions, up to a maximum of 25 birds, shall be submitted to an authorized laboratory and examined for the presence of group D salmonella in accordance with §§147.10 and 147.11 of this chapter. Cultures from group D positive samples shall be serotyped. (vi) Hatching eggs produced by the flock are collected as quickly as possible and are handled as described in §147.22 of this chapter. (vii) Hatching eggs produced by the flock are incubated in a hatchery that is in compliance with the recommendations in §§147.23 and 147.24(b) of this chapter, and the hatchery must have been sanitized either by a procedure approved by the Official State Agency or by fumigation. (2) If Salmonella enteritidis serotype Enteritidis (SE) is isolated from a specimen taken from a bird in the flock, except as provided in paragraph (h)(3) of this section, the flock shall not be eligible for this classification. (3) If SE is isolated from an environmental sample collected from the flock in accordance with paragraph (h)(1)(iv) of this section, 25 randomly selected live birds from the flock and/or 500 cloacal swabs collected in accordance with §147.12(a)(2) of this chapter must be bacteriologically examined for SE as described in §147.11 of this chapter. If only one 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. If no SE is recovered from any of the specimens in the second sample, the flock will be eligible for the classification and will remain eligible for this classification if the flock is tested in accordance with paragraph (h)(1)(v) of this section each 30 days and no positive samples are found. (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, or great-grandparent flock that is removed from the U.S. S. Enteritidis Clean program may be reinstated whenever the following conditions are met: (i) The owner attests that corrective measures have been implemented, which may include one or more of the following: (A) Test and slaughter infected birds based on blood tests of every bird in the flock, with either pullorum antigen or by a federally licensed Salmonella enteritidis enzyme-linked immunosorbent assay (ELISA) test when the flock is more than 4 months of age. (B) Perform other corrective actions including, but not limited to, vaccination, medication, cleaning and disinfection of houses, rodent control, and movement of uninfected birds to premises that have been determined to be environmentally negative for S. enteritidis as described in §147.12(a) of this chapter. (C) One hundred percent of blood samples from the birds moved to the clean premises are tested negative for Salmonella pullorum and group D Salmonella. All birds with positive or inconclusive reactions, up to a maximum of 25 birds, shall be submitted to an authorized laboratory and examined for the presence of group D Salmonella, as described in §147.11 of this chapter. Cultures from positive samples shall be serotyped. (D) Two consecutive environmental drag swabs taken at the clean premises collected as specified in §147.12(a) of this chapter 4 weeks apart are negative for S. enteritidis. (E) Other corrective measures at the discretion of the Official State Agency. (ii) Following reinstatement, a flock will remain eligible for this classification if the flock is tested in accordance with paragraph (h)(1)(v) of this section every 30 days and no positive samples are found and the flock meets the requirements set forth in §145.33(h). (i) U.S. Salmonella Monitored. This program is intended to be the basis from which the breeding-hatching industry may conduct a program for the prevention and control of Salmonellosis. It is intended to reduce the incidence of Salmonella organisms in hatching eggs and chicks through an effective and practical sanitation program at the breeder farm and in the hatchery. This will afford other segments of the poultry industry an opportunity to reduce the incidence of Salmonella in their products. (1) A flock and the hatching eggs and chicks produced from it that have met the following requirements, as determined by the Official State Agency: (i) The flock shall originate from a source where sanitation and management practices, as outlined in §145.33(d)(1), are conducted; (ii) The flock is maintained in compliance with §§147.21, 147.24(a), and 147.26 of this chapter; (iii) If feed contains animal protein, the protein products must have a minimum moisture content of 14.5 percent and 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 lb pressure during the manufacturing process; (iv) Feed shall be stored and transported in a manner to prevent possible contamination; (v) Chicks shall be hatched in a hatchery meeting the requirements of §§147.23 and 147.24(b) of this chapter and sanitized or fumigated (see §147.25 of this chapter). (vi) An Authorized Agent shall take environmental samples from the hatchery every 30 days; i.e., meconium or chick papers. An authorized laboratory for Salmonella shall examine the samples bacteriologically; (vii) An Authorized Agent shall take environmental samples as described in §147.12 of this chapter from each flock at 4 months of age and every 30 days thereafter. An authorized laboratory for Salmonella shall examine the environmental samples bacteriologically; (viii) Owners of flocks may vaccinate with a paratyphoid vaccine: Provided, That a sample of 350 birds, which will be banded for identification, shall remain unvaccinated until the flock reaches at least 4 months of age. (2) The Official State Agency may use the procedures described in §147.14 of this chapter to monitor the effectiveness of the egg sanitation practices. (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. (j) U.S. M. Gallisepticum Monitored. (1) A multiplier breeding flock in which all birds or a sample of at least 30 birds per house has been tested for M. gallisepticum as provided in §145.14(b) when more than 4 months of age: Provided, That to retain this classification, a minimum of 30 birds per house shall be tested again at 36 to 38 weeks and at 48 to 50 weeks at a minimum: And provided further, That each 30-bird sample should come from 2 locations within the house (15 from the front half of the house and 15 from the back half of the house). A representative sample of males and females should be sampled. The samples shall be marked “male” or “female.” (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, That U.S. M. Gallisepticum Monitored chicks from multiplier breeding flocks shall be produced in incubators and hatchers in which only eggs from flocks qualified under paragraph (j)(1) of this section are set. Eggs from U.S. M. Gallisepticum Monitored multiplier breeding flocks shall not be set in hatchers or incubators in which eggs from U.S. M. Gallisepticum Clean primary breeding flocks qualified under paragraph (c)(1)(i) of this section are set. (3) U.S. M. Gallisepticum Monitored chicks shall be boxed in clean boxes and delivered in trucks that have been cleaned and disinfected as described in §147.24(a) of this chapter. (k) U.S. M. Synoviae Monitored. (1) A multiplier breeding flock in which all birds or a sample of at least 30 birds per house has been tested for M. synoviae as provided in §145.14(b) when more than 4 months of age: Provided, That to retain this classification, a minimum of 30 birds per house shall be tested again at 36 to 38 weeks and at 48 to 50 weeks at a minimum: And provided further, That each 30-bird sample should come from 2 locations within the house (15 from the front half of the house and 15 from the back half of the house). A representative sample of males and females should be sampled. The samples shall be marked “male” or “female.” (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, That U.S. M. Synoviae Monitored chicks from multiplier breeding flocks shall be produced in incubators and hatchers in which only eggs from flocks qualified under paragraph (k)(1) of this section are set. Eggs from U.S. M. Synoviae Monitored multiplier breeding flocks shall not be set in hatchers or incubators in which eggs from U.S. M. Synoviae Clean primary breeding flocks qualified under paragraph (e)(1)(i) of this section are set. (3) U.S. M. Synoviae Monitored chicks shall be boxed in clean boxes and delivered in trucks that have been cleaned and disinfected as described in §147.24(a) of this chapter. (l) U.S. Avian Influenza Clean. This program is intended to be the basis from which the breeding-hatchery industry may conduct a program for the prevention and control of avian influenza. It is intended to determine the presence of avian influenza in primary breeding chickens through routine serological surveillance of each participating breeding flock. A flock and the hatching eggs and chicks produced from it will qualify for this classification when the Official State Agency determines that they have met one of the following requirements: (1) It is a primary breeding flock in which a minimum of 30 birds have been tested negative for antibodies to avian influenza 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. (2) It is a multiplier breeding flock in which a minimum of 30 birds have been tested negative for antibodies 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 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 is tested within each 180-day period. [36 FR 23112, Dec. 3, 1971] Editorial Note: For (a) U.S. Pullorum-Typhoid-Clean State. (1) A State will be declared a U.S. Pullorum-Typhoid Clean State when it has been determined by the Service that: (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), and §145.53(b)(3)(i) through (vii). (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, That pullorum disease or fowl typhoid found within the preceding 24 months in waterfowl, exhibition poultry, and game bird breeding flocks will not prevent a State, which is otherwise eligible from qualifying. (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. (1) A State will be declared a U.S. M. Gallisepticum Clean State, Meat-Type Chickens, when it has been determined by the Service that: (i) No M. gallisepticum is known to exist nor to have existed in meat-type chicken breeding flocks in production within the State during the preceding 12 months; (ii) All meat-type chicken breeding flocks in production are classified as U.S. M. Gallisepticum Clean or have met equivalent requirements for M. gallisepticum control under official supervision; (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 control under official supervision; (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 infection in chickens from meat-type chicken breeding flocks are promptly followed by an investigation by the Official State Agency to determine the origin of the infection; (vii) All chickens from meat-type chicken breeding flocks found to be infected with M. gallisepticum are quarantined until marketed under supervision of the Official State Agency. (2) Discontinuation of any of the conditions described in paragraph (b)(1) of this section, or if repeated outbreaks of M. gallisepticum occur in meat-type chicken breeding flocks described in paragraph (b)(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 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] Except where the context otherwise requires, for the purposes of this subpart the following terms shall be construed, respectively, to mean: Poults. Newly hatched turkeys. [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] (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 shall be fumigated (see §147.25 of this chapter) 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] Participating flocks, and the eggs and poults produced from them, which have met the respective requirements specified in this section may be designated by the following terms and the corresponding designs illustrated in §145.10: (a) [Reserved] (b) U.S. Pullorum-Typhoid Clean. A flock in which freedom from pullorum and typhoid has been demonstrated to the official State agency under the criteria in one of the following paragraphs (b)(1) through (5) of this section: Provided, That a flock qualifying by means of a blood test shall be tested within the past 12 months, except that the retesting of a participating flock which is retained for more than 12 months shall be conducted a minimum of 4 weeks after the induction of molt. (See §145.14 relating to the official blood test where applicable.) (1) It has been officially blood tested with no reactors. (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 either no poultry or a flock not classified as U.S. Pullorum-Typhoid Clean were located the previous year; Provided, That an Authorized Agent must blood test up to 300 birds per flock, as described in §145.14, if the Official State Agency determines that the flock has been exposed to pullorum-typhoid. In making determinations of exposure and setting the number of birds to be blood tested, the Official State Agency shall evaluate the results of any blood tests, described in §145.14(a)(1), that were performed on an unclassified flock located on the premises during the previous year; the origins of the unclassified flock; and the probability of contacts between the flock for which qualification is being sought and (a) infected wild birds, (b) contaminated feed or waste, or (c) birds, equipment, supplies, or personnel from flocks infected with pullorum-typhoid. (3) It is a multiplier breeding flock, or a breeding flock composed of progeny of a primary breeding flock which is intended solely for the production of multiplier breeding flocks, that originated from U.S. Pullorum-Typhoid Clean breeding flocks or from flocks that met equivalent requirements under official supervision, and is located in a State in which it has been determined by the Service that: (i) All turkey hatcheries within the State are qualified as “National Plan Hatcheries” or have met equivalent requirements for pullorum-typhoid control under official supervision; (ii) All turkey hatchery supply flocks within the State are qualified as U.S. Pullorum-Typhoid Clean or have met equivalent requirements for pullorum-typhoid control under official supervision: Provided, That if other domesticated fowl, except waterfowl, are maintained on the same premises as the participating flock, freedom from pullorum-typhoid infection shall be demonstrated by an official blood test of each of these fowl; (iii) All shipments of products other than U.S. Pullorum-Typhoid Clean, or equivalent, into the State are prohibited; (iv) All persons performing poultry disease diagnostic services within the State are required to report to the Official State Agency within 48 hours the source of all poultry specimens from which S. pullorum or S. gallinarum is isolated; (v) All reports of any disease outbreak involving a disease covered under the Plan are promptly followed by an investigation by the Official State Agency to determine the origin of the infection; Provided, That if the origin of the infection involves another State, or if there is exposure to poultry in another State from the infected flock, then the National Poultry Improvement Plan will conduct an investigation; (vi) All flocks found to be infected with pullorum or typhoid are quarantined until marketed or destroyed under the supervision of the Official State Agency, or until subsequently blood tested, following the procedure for reacting flocks as contained in §145.14(a)(5), and all birds fail to demonstrate pullorum or typhoid infection; (vii) [Reserved] (viii) Discontinuation of any of the conditions or procedures described in paragraphs (b)(3)(i), (ii), (iii), (iv), (v), and (vi) of this section, or the occurrence of repeated outbreaks of pullorum or typhoid in turkey breeding flocks within or originating within the State shall be grounds for the Service to revoke its determination that such conditions and procedures have been met or complied with. Such action shall not be taken until a thorough investigation has been made by the Service and the Official State Agency has been given an opportunity to present its views. (4) It is a multiplier breeding flock located in a State which has been determined by the Service to be in compliance with the provisions of paragraph (b)(3) of this section and in which pullorum disease or fowl typhoid is not known to exist nor to have existed in turkey hatchery supply flocks within the State during the preceding 24 months. (5) It is a primary breeding flock located in a State determined to be in compliance with the provisions of paragraph (b)(4), of this section and in which a sample of 300 birds from flocks of more than 300, and each bird in flocks of 300 or less, has been officially tested for pullorum-typhoid with no reactors: Provided, That a bacteriological examination monitoring program acceptable to the Official State Agency and approved by the Service may be used in lieu of blood testing. (c) U.S. M. Gallisepticum Clean. (1) A flock maintained in accordance with the conditions and procedures described in §147.26 of this chapter, and in which no reactors are found when a random sample of at least 10 percent of the birds in the flock, or 300 birds in flocks of more than 300 and each bird in flocks of 300 or less, is tested when more than 12 weeks of age, in accordance with the procedures described in §145.14(b): Provided, That to retain this classification, a minimum of 30 samples from male flocks and 60 samples from female flocks shall be retested at 28–30 weeks of age and at 4–6 week intervals thereafter. (2) A flock qualified as U.S. M. Gallisepticum Clean may retain the classification through its first egg-laying cycle, provided it is maintained in isolation and no evidence of M. gallisepticum infection is revealed. A flock which is molted following completion of an egg-laying cycle and subsequently brought back into production, shall be retested within 2 weeks prior to production, as described in paragraph (c)(1) of this section. A State inspector shall visit with the owner or manager of each flock at least once during each laying cycle to discuss and ascertain whether the applicable conditions outlined in §147.26 of this chapter are being met. If a flock proves to be infected with M. gallisepticum, it shall lose this classification. (3) In order to sell hatching eggs or poults of this classification, all hatching eggs and poults handled by the participant must be of this classification. (d) U.S. M. Meleagridis Clean. (1) A flock in which freedom from M. meleagridis has been demonstrated under the following criteria: (i) A sample of 100 birds from each flock has been tested for M. meleagridis when more than 12 weeks of age: Provided, That to retain this classification, a minimum of 30 samples from male flocks and 60 samples from female flocks shall be retested at 28–30 weeks of age and at 4–6 week intervals thereafter. (2) The official blood tests for M. meleagridis shall be the serum plate agglutination test, the tube agglutination test, or the microagglutination test. The hemagglutination inhibition (HI) test, microhemagglutination inhibition test, serum plate dilution test, microagglutination test and the enzyme-linked immunosorbent assay (ELISA)5 5 See footnote 3 to §145.14(b)(1). (3) The tests shall be conducted using M. meleagridis antigens and the protocols for testing approved by the Department or the Official State Agency. (4) When reactors to the official test are found and can be identified, 10 tracheal swabs and/or vaginal or phallus swabs and their corresponding blood samples shall be submitted to a laboratory for serological and cultural examination. If reactors cannot be identified, at least 30 tracheal swabs and/or vaginal or phallus swabs and their corresponding blood samples shall be submitted. In a flock with a low reactor rate (less than 5 reactors) the reactors may be submitted to the laboratory within 10 days for serology, necropsy, and thorough bacteriological examination. (5) If a mycoplasma is isolated, the organism must be serotyped. If M. meleagridis is isolated, the block shall be considered infected. (e) U.S. M. Synoviae Clean. (1) All birds, or a sample of at least 100 birds from flocks of more than 100 and each bird in flocks of 100 or less, have been tested for M. synoviae when more than 12 weeks of age in accordance with the procedures in §145.14(b): Provided, That to retain this classification a minimum of 30 samples from male flocks and 60 samples from female flocks shall be retested at 28–30 weeks of age and at 4–6 week intervals thereafter. (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 §147.6 of this chapter will be used to determine the status of the flock. (3) Flocks located on premises which, during 3 consecutive years, have contained breeding flocks qualified as U.S. M. Synoviae Clean, as described in paragraph (e)(1) above, may qualify for this classification by a negative blood test of at least 100 birds from flocks of more than 100 and each bird in flocks of 100 or less, when more than 12 weeks of age, and by testing a minimum of 30 samples from male flocks and 60 samples from female flocks at 28–30 weeks of age and at 45 weeks of age. (f) U.S. Sanitation Monitored, Turkeys. A flock or hatchery whose owner is controlling or reducing the level of salmonella through compliance with sanitation and management practices as described in subpart C of part 147 of this chapter, and where the following monitoring, testing, and management practices are conducted: (1) Hatchery debris (dead germ hatching eggs, fluff, and meconium collected by sexors), a sample of the poults that died within 10 days after hatching, or both, from each 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, disinfected, and examined bacteriologically for the presence of Salmonella by an Authorized Agent, as described in §147.12 of this chapter. (3) Feed for turkeys in the candidate and breeding flock should meet the following requirements: (i) All feed manufactured in pellet form must have a maximum moisture content of 13.5 percent upon delivery to the farm. It should have been preconditioned to the minimum of one of the following parameters before pelleting: (A) Feed is to reach a minimum temperature of 185 °F for a minimum of 6 minutes of retention in the conditioning chamber. The conditioned mash feed moisture must be a minimum of 16 percent during the conditioning process. This method utilizes time retention to allow permeation to the center core of each feed particle; or (B) The feed is to be pressurized in order to expedite the transfer of the heat and moisture to the core of each feed particle. The feed should be conditioned to the parameters of a minimum of 16 percent moisture and 200 °F; or (C) The feed should be submitted to pressurization to the extent that the initial feed temperature rises to 235 °F for 4 seconds; or (D) The feed should be submitted to an equivalent thermal lethality treatment; or (E) A Food and Drug Administration (FDA)-approved product for Salmonella control should be added to the finished pellets. (ii) Mash feed should be treated with an FDA-approved Salmonella control product. (iii) All feed is to be stored and transported in such a manner as to prevent possible contamination with pathogenic bacteria. (iv) FDA-approved products for Salmonella control may be added to either unfinished or finished feed. (4) Environmental samples shall be taken by an Authorized Agent, as described in §147.12 of this chapter, from each flock at 12–20 weeks of age and examined bacteriologically at an authorized laboratory for Salmonella. (5) Owners of flocks found infected with a paratyphoid Salmonella may vaccinate these flocks with an autogenous bacterin with a potentiating agent.6 6 Preparation and use of this type of vaccine may be regulated by state statutes. (6) Environmental samples shall be taken by an Authorized Agent, as described in §147.12 of this chapter, from each flock at 35–50 weeks of age and from each molted flock at midlay, and examined bacteriologically at an authorized laboratory for Salmonella. (7) Hatchery debris (dead germ hatching eggs, fluff, and meconium collected by sexors), a sample of the poults that died within 10 days after hatching, or both shall be cultured from poults produced from hatching eggs from each flock, as a means of evaluating the effectiveness of the control procedures. (g) U.S. H5/H7 Avian Influenza Clean. This program is intended to be the basis from which the turkey breeding industry may conduct a program for the prevention and control of the H5 and H7 subtypes of avian influenza. It is intended to determine the presence of the H5 and H7 subtypes of avian influenza in breeding turkeys through routine serological surveillance of each participating breeding flock. A flock, and the hatching eggs and poults produced from it, will qualify for this classification when the Official State Agency determines that it has met one of the following requirements: (1) It is a primary breeding flock in which a minimum of 30 birds has been tested negative for antibodies to the H5 and H7 subtypes of avian influenza by the agar gel immunodiffusion test specified in §147.9 of this chapter 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 are tested within each 90-day period. (2) It is a multiplier breeding flock in which a minimum of 30 birds has been tested negative for antibodies to the H5 and H7 subtypes of avian influenza by the agar gel immunodiffusion test specified in §147.9 of this chapter 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) 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. [36 FR 23112, Dec. 3, 1971] Editorial Note: For (a) U.S. Pullorum-Typhoid Clean State. (1) A State will be declared a U.S. Pullorum-Typhoid Clean State when it has been determined by the Service that: (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), and §145.53(b)(3)(i) through (vii). (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, That pullorum disease or fowl typhoid found within the preceding 24 months in waterfowl, exhibition poultry, and game bird breeding flocks will not prevent a State, which is otherwise eligible, from qualifying. (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. (1) A State will be declared a U.S. Pullorum-Typhoid Clean State, Turkeys, when it has been determined by the Service that: (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. (1) A State will be declared a U.S. M. Gallisepticum Clean State, Turkeys when it has been determined by the Service that: (i) No M. gallisepticum is known to exist nor to have existed in turkey breeding flocks in production within the State during the preceding 12 months. (ii) All turkey breeding flocks in production are classified as U.S. M. Gallisepticum Clean or have met equivalent requirements for M. gallisepticum control under official supervision. (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 control under official supervision. (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 infection in turkeys are promptly followed by an investigation by the Official State Agency to determine the origin of the infection. (vii) All turkey flocks found to be infected with M. gallisepticum are quarantined until marketed under supervision of the Official State Agency. (2) Discontinuation of any of the conditions described in paragraph (c)(1) of this section, or if repeated outbreaks of M. gallisepticum occur in turkey breeding flocks described in paragraph (c)(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. (3) If a State retains this status for 2 or more years, individual breeding flocks in the State may qualify for an M. gallisepticum classification based on a negative test of a sample of 100 birds. (d) U.S. M. Synoviae Clean State, Turkeys. (1) A State will be declared a U.S. M. Synoviae Clean State, Turkeys, if the Service determines that: (i) No Mycoplasma synoviae is known to exist nor to have existed in turkey breeding flocks in production within the State during the preceding 12 months; (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 control under official supervision; (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 control under official supervision; (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 infection in turkeys are promptly followed by an investigation by the Official State Agency to determine the origin of the infection; and (vii) All turkey breeding flocks found to be infected with M. synoviae are quarantined until marketed under supervision of the Official State Agency. (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. (1) A State will be declared a U.S. M. Meleagridis Clean State, Turkeys, if the Service determines that: (i) No Mycoplasma meleagridis is known to exist nor to have existed in turkey breeding flocks in production within the State during the preceding 12 months; (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 control under official supervision; (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 control under official supervision; (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 infection in turkeys are promptly followed by an investigation by the Official State Agency to determine the origin of the infection; and (vii) All turkey breeding flocks found to be infected with M. meleagridis are quarantined until marketed under supervision of the Official State Agency. (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. [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] Except where the context otherwise requires, for the purposes of this subpart the following terms shall be construed, respectively, to mean: Exhibition Poultry. Domesticated fowl which are bred for the combined purposes of meat or egg production and competitive showing. Game birds. Domesticated fowl such as pheasants, partridge, quail, grouse, and guineas, but not doves and pigeons. Waterfowl. Domesticated fowl that normally swim, such as ducks and geese. [36 FR 23112, Dec. 3, 1971. Redesignated at 44 FR 61586, Oct. 26, 1979, and amended at 59 FR 12799, Mar. 18, 1994] Participating flocks of waterfowl, exhibition poultry, and game birds, 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 E. (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 (see §147.25 of this chapter) or otherwise sanitized. (c) 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 printouts of computerized monthly shipping and receiving reports in lieu of VS Form 9–3, “Report of Sales of Hatching Eggs, Chicks, and Poults.” (d) 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. [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] Participating flocks, and the eggs and baby 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. A flock in which freedom from pullorum and typhoid has been demonstrated to the Official State Agency under the criteria in one of the following paragraphs (b)(1) through (5) of this section (See §145.14 relating to the official blood test where applicable.): (1) It has been officially blood tested within the past 12 months with no reactors. (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 either no poultry or a flock not classified as U.S. Pullorum-Typhoid Clean were located the previous year; Provided, That an Authorized Agent must blood test up to 300 birds per flock, as described in §145.14, if the Official State Agency determines that the flock has been exposed to pullorum-typhoid. In making determinations of exposure and setting the number of birds to be blood tested, the Official State Agency shall evaluate the results of any blood tests, described in §145.14(a)(1), that were performed on an unclassified flock located on the premises during the previous year; the origins of the unclassified flock; and the probability of contacts between the flock for which qualification is being sought and (a) infected wild birds, (b) contaminated feed or waste, or (c) birds, equipment, supplies, or personnel from flocks infected with pullorum-typhoid. (3) It is a multiplier breeding flock 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, That if other domesticated fowl, except waterfowl, are maintained on the same premises as the participating flock, freedom from pullorum-typhoid infection shall be demonstrated by an official blood test of each of these fowl; (iii) All shipments of products other than U.S. Pullorum-Typhoid Clean, or equivalent, into the State are prohibited; (iv) All persons performing poultry disease diagnostic services within the State are required to report to the Official State Agency within 48 hours the source of all poultry specimens from which S. pullorum or S. gallinarum is isolated; (v) All reports of any disease outbreak involving a disease covered under the Plan are promptly followed by an investigation by the Official State Agency to determine the origin of the infection; Provided, That if the origin of the infection involves another State, or if there is exposure to poultry in another State from the infected flock, then the National Poultry Improvement Plan will conduct an investigation; (vi) All flocks found to be infected with pullorum or typhoid are quarantined until marketed or destroyed under the supervision of the Official State Agency, or until subsequently blood tested, following the procedure for reacting flocks as contained in §145.14(a)(5), and all birds fail to demonstrate pullorum or typhoid infection; (vii) 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 no reactors: Provided, That a bacteriological examination monitoring program or serological examination monitoring program for game birds acceptable to the Official State Agency and approved by the Service may be used in lieu of annual blood testing: And Provided further, That when a flock is a waterfowl or exhibition poultry primary breeding flock located in a State which has been deemed to be a U.S. Pullorum-Typhoid Clean State for the past three years, and during which time no isolation of pullorum or typhoid has been made that can be traced to a source in that State, a bacteriological examination monitoring program or a serological examination monitoring program acceptable to the Official State Agency and approved by the Service may be used in lieu of annual blood testing. (c) U.S. M. Gallisepticum Clean. (1) A flock maintained in compliance with the provisions of §147 .26 of this chapter and in which freedom from M. gallisepticum has been demonstrated under the criteria specified in paragraph (c)(1)(i) or (ii) of this section. (i) It is a flock in which all birds or a sample of at least 300 birds has been tested for M. gallisepticum as provided in §145.14(b) when more than 4 months of age or upon reaching sexual maturity: Provided, That to retain this classification, a random sample of serum or egg yolk from at least 5 percent of the birds in the flock, but at least 30 birds, shall be tested at intervals of not more than 90 days: And provided further, That a sample comprised of less than 5 percent may be tested at any one time, with the approval of the Official State Agency and the concurrence of the Service, provided that a total of at least 5 percent of the birds in the flock, but at least 30 birds, is tested within each 90–day period; or (ii) It is a multiplier breeding flock which originated as U.S. M. Gallisepticum Clean baby poultry from primary breeding flocks and a random sample comprised of 50 percent of the birds in the flock, with a maximum of 200 birds and a minimum of 30 birds per flock, has been tested for M. gallisepticum as provided in §145.14(b) when more than 4 months of age or upon reaching sexual maturity: Provided, That to retain this classification, the flock shall be subjected to one of the following procedures: (A) At intervals of not more than 90 days, a random sample of serum or egg yolk from at least 2 percent of the birds in the flock, with a minimum of 30 birds per pen, 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, That U.S. M. Gallisepticum Clean baby poultry from primary breeding flocks shall be produced in incubators and hatchers in which only eggs from flocks qualified under paragraph (c)(1)(i) of this section are set. (3) U.S. M. Gallisepticum Clean baby poultry shall be boxed in clean boxes and delivered in trucks that have been cleaned and disinfected as described in §147.24(a) of this chapter. (d) U.S. M. Synoviae Clean. (1) A flock maintained in compliance with the provisions of §147.26 of this chapter and in which freedom from Mycoplasma synoviae has been demonstrated under the criteria specified in paragraph (d)(1)(i) or (d)(1)(ii) of this section. (i) It is a flock in which a minimum of 300 birds has been tested for M. synoviae as provided in §145.14(b) when more than 4 months of age: Provided, That to retain this classification, a sample of at least 150 birds shall be tested at intervals of not more than 90 days: And provided further, That a sample comprised of fewer than 150 birds may be tested at any one time with the approval of the Official State Agency and the concurrence of the Service, provided that a minimum of 150 birds is tested within each 90-day period; or (ii) It is a multiplier breeding flock that originated as U.S. M. Synoviae Clean chicks from primary breeding flocks and from which a sample comprised of a minimum of 75 birds has been tested for M. synoviae as provided in §145.14(b) when more than 4 months of age: Provided, That to retain this classification, the flock shall be subjected to one of the following procedures: (A) At intervals of not more than 90 days, a sample of 50 birds shall be tested: Provided, That a sample of fewer than 50 birds may be tested at any one time, provided that a minimum of 30 birds per flock with a minimum of 15 birds per pen, whichever is greater, is tested each time and a total of at least 50 birds is tested within each 90-day period; or (B) At intervals of not more than 30 days, egg yolk testing shall be conducted in accordance with §147.8 of this chapter. (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, That U.S. M. Synoviae Clean chicks from primary breeding flocks shall be produced in incubators and hatchers in which only eggs from flocks qualified under paragraph (d)(1)(i) or (d)(1)(ii) of this section are set. (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 §147.24(a) of this chapter. (e) U.S. Avian Influenza Clean. This program is intended to be the basis from which the breeding-hatchery industry may conduct a program for the prevention and control of avian influenza. It is intended to determine the presence of avian influenza in waterfowl, exhibition poultry, and game bird breeding flocks through routine serological surveillance of each participating breeding flock. A flock, and the hatching eggs and chicks produced from it, will qualify for this classification when the Official State Agency determines that it has met one of the following requirements: (1) It is a primary breeding flock in which a minimum of 30 birds has been tested negative for antibodies to avian influenza by the agar gel immunodiffusion test specified in §147.9 of this chapter 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 are tested within each 90-day period. (2) It is a multiplier breeding flock in which a minimum of 30 birds has been tested negative for antibodies to avian influenza by the agar gel immunodiffusion test specified in §147.9 of this chapter 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. [36 FR 23112, Dec. 3, 1971, as amended at 40 FR 1503, Jan. 8, 1975; 41 FR 48725, Nov. 5, 1976. Redesignated at 44 FR 61586, Oct. 26, 1979, and amended at 47 FR 21993, May 29, 1982; 48 FR 57473, Dec. 30, 1983; 50 FR 19900, May 13, 1985; 54 FR 23956, 23957, June 5, 1989; 57 FR 57342, Dec. 4, 1992; 59 FR 12799, Mar. 18, 1994; 62 FR 44070, Aug. 19, 1997; 63 FR 3, Jan. 2, 1998; 65 FR 8019, Feb. 17, 2000; 67 FR 8469, Feb. 25, 2002; 68 FR 64512, Nov. 14, 2003; 69 FR 7680, Feb. 19, 2004] (a) U.S. Pullorum-Typhoid Clean State. (1) A State will be declared a U.S. Pullorum-Typhoid Clean State when it has been determined by the Service that: (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), and §145.53(b)(3)(i) through (vii). (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, That pullorum disease or fowl typhoid found within the preceding 24 months in waterfowl, exhibition poultry, and game bird breeding flocks will not prevent a State, which is otherwise eligible, from qualifying. (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] Source: 63 FR 40010, July 27, 1998, unless otherwise noted.
Except where the context otherwise requires, for the purposes of this subpart the following terms shall be construed, respectively, to mean: Chicks. Newly hatched ostriches, emus, rheas, or cassowaries. Ostrich. Birds of the species Struthio camelus, including all subspecies and subspecies hybrids. [63 FR 40010, July 27, 1998, as amended at 65 FR 8019, Feb. 17, 2000] 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 (see §147.22 of this chapter). (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] 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. A flock in which freedom from pullorum and typhoid has been demonstrated to the Official State Agency under the criteria in paragraph (a)(1) or (a)(2) of this section. (See §145.14(a) relating to the official blood test for pullorum-typhoid where applicable.) (1) It has been officially blood tested within the past 12 months with no reactors. (2) It is a multiplier or primary breeding flock in which a sample of each bird in flocks of 30 or fewer birds, a minimum of 30 birds from flocks up to 300 birds, or 10 percent of all birds from flocks exceeding 300 birds has been officially tested for pullorum-typhoid within the past 12 months with no reactors: Provided, That a bacteriological examination monitoring program for ostriches, emus, rheas, or cassowaries acceptable to the Official State Agency and approved by the Service may be used in lieu of annual blood testing: And provided further, That when a flock is a multiplier breeding flock located in a State which 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, a bacteriological examination monitoring program or a serological examination monitoring program acceptable to the Official State Agency and approved by the Service may be used in lieu of annual blood testing. (b) [Reserved] [63 FR 40010, July 27, 1998, as amended at 65 FR 8019, Feb. 17, 2000]
Title 9: Animals and Animal Products
PART 145—NATIONAL POULTRY IMPROVEMENT PLAN
Section Contents
§ 145.1 Definitions.
§ 145.2 Administration.
§ 145.3 Participation.
§ 145.4 General provisions for all participants.
§ 145.5 Specific provisions for participating flocks.
§ 145.6 Specific provisions for participating hatcheries.
§ 145.7 Specific provisions for participating dealers.
§ 145.8 Terminology and classification; general.
§ 145.9 Terminology and classification; hatcheries and dealers.
§ 145.10 Terminology and classification; flocks, products, and States.
§ 145.11 Supervision.
§ 145.12 Inspections.
§ 145.13 Debarment from participation.
§ 145.14 Blood testing.
§ 145.21 Definitions.
§ 145.22 Participation.
§ 145.23 Terminology and classification; flocks and products.
§ 145.24 Terminology and classification; States.
§ 145.31 Definitions.
§ 145.32 Participation.
§ 145.33 Terminology and classification; flocks and products.
§ 145.34 Terminology and classification; States.
§ 145.41 Definitions.
§ 145.42 Participation.
§ 145.43 Terminology and classification; flocks and products.
§ 145.44 Terminology and classification; States.
§ 145.51 Definitions.
§ 145.52 Participation.
§ 145.53 Terminology and classification; flocks and products.
§ 145.54 Terminology and classification; States.
§ 145.61 Definitions.
§ 145.62 Participation.
§ 145.63 Terminology and classification; flocks and products.
Subpart A—General Provisions
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§ 145.1 Definitions.
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§ 145.2 Administration.
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§ 145.3 Participation.
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§ 145.4 General provisions for all participants.
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§ 145.5 Specific provisions for participating flocks.
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§ 145.6 Specific provisions for participating hatcheries.
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§ 145.7 Specific provisions for participating dealers.
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§ 145.8 Terminology and classification; general.
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§ 145.9 Terminology and classification; hatcheries and dealers.
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§ 145.10 Terminology and classification; flocks, products, and States.
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§ 145.11 Supervision.
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§ 145.12 Inspections.
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§ 145.13 Debarment from participation.
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§ 145.14 Blood testing.
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Subpart B—Special Provisions for Egg Type Chicken Breeding Flocks and Products
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§ 145.21 Definitions.
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§ 145.22 Participation.
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§ 145.23 Terminology and classification; flocks and products.
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§ 145.24 Terminology and classification; States.
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Subpart C—Special Provisions for Meat Type Chicken Breeding Flocks and Products
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§ 145.31 Definitions.
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§ 145.32 Participation.
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§ 145.33 Terminology and classification; flocks and products.
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§ 145.34 Terminology and classification; States.
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Subpart D—Special Provisions for Turkey Breeding Flocks and Products
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§ 145.41 Definitions.
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§ 145.42 Participation.
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§ 145.43 Terminology and classification; flocks and products.
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§ 145.44 Terminology and classification; States.
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Subpart E—Special Provisions for Waterfowl, Exhibition Poultry, and Game Bird Breeding Flocks and Products
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§ 145.51 Definitions.
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§ 145.52 Participation.
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§ 145.53 Terminology and classification; flocks and products.
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§ 145.54 Terminology and classification; States.
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Subpart F—Special Provisions for Ostrich, Emu, Rhea, and Cassowary Breeding Flocks and Products
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§ 145.61 Definitions.
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§ 145.62 Participation.
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§ 145.63 Terminology and classification; flocks and products.
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