9 C.F.R. Subpart A—General Provisions
Title 9 - Animals and Animal Products
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
Title 9: Animals and Animal Products
PART 145—NATIONAL POULTRY IMPROVEMENT PLAN
Subpart A—General Provisions
§ 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.
