Livestock Improvement (9 CFR 145.1-149.9)

885 SUBCHAPTER G—LIVESTOCK IMPROVEMENT PART 145—NATIONAL POULTRY IM PROVEMENT PLAN FOR BREED ING POULTRY Subpart A—General Provisions Sec. 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; gen eral. 145.9 Terminology and classification; hatch eries and dealers. 145.10 Terminology and classification; flocks, products, and States. 145.11 Supervision. 145.12 Inspections. 145.13 Debarment from participation. 145.14 Testing. 145.15 Diagnostic surveillance program for low pathogenic avian influenza. Subpart B—Special Provisions for Multiplier Egg-Type Chicken Breeding Flocks and Products 145.21 Definitions. 145.22 Participation. 145.23 Terminology and classification; flocks and products. 145.24 Terminology and classification; States. Subpart C—Special Provisions for Multiplier Meat-Type Chicken Breeding Flocks and Products 145.31 Definitions. 145.32 Participation. 145.33 Terminology and classification; flocks and products. 145.34 Terminology and classification; States. Subpart D—Special Provisions for Turkey Breeding Flocks and Products 145.41 Definitions. 145.42 Participation. 145.43 Terminology and classification; flocks and products. 145.44 Terminology and classification; States. 145.45 Terminology and classification; com partments. Subpart E—Special Provisions for Hobbyist and Exhibition Waterfowl, Exhibition Poultry, and Game Bird Breeding Flocks and Products 145.51 Definitions. 145.52 Participation. 145.53 Terminology and classification; flocks and products. 145.54 Terminology and classification; States. Subpart F—Special Provisions for Ostrich, Emu, Rhea, and Cassowary Breeding Flocks and Products 145.61 Definitions. 145.62 Participation. 145.63 Terminology and classification; flocks and products. Subpart G—Special Provisions for Primary Egg-Type Chicken Breeding Flocks and Products 145.71 Definitions. 145.72 Participation. 145.73 Terminology and classification; flocks and products. 145.74 Terminology and classification; com partments. Subpart H—Special Provisions for Primary Meat-Type Chicken Breeding Flocks and Products 145.81 Definitions. 145.82 Participation. 145.83 Terminology and classification; flocks and products. 145.84 Terminology and classification; com partments. Subpart I—Special Provisions for Meat Type Waterfowl Breeding Flocks and Products 145.91 Definitions. 145.92 Participation. 145.93 Terminology and classification; flocks and products. 145.94 Terminology and classification; States. 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. VerDate Sep<11>2014 13:56 Feb 14, 2018 Jkt 244028 PO 00000 Frm 00895 Fmt 8010 Sfmt 8010 Q:\09\9V1.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 886 9 CFR Ch. I (1–1–18 Edition) § 145.1 Subpart A—General Provisions § 145.1 Definitions. Words used in this part in the sin gular 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 partici pating hatchery. Animal and Plant Health Inspection Service. The Animal and Plant Health Inspection Service of the U.S. Depart ment of Agriculture. Authorized agent. Any person des ignated under § 145.11(a) to collect offi cial samples for submission to an au thorized laboratory in accordance with part 147 of this subchapter. Authorized laboratory. An authorized laboratory is a laboratory that meets the requirements of § 147.52 and is thus qualified to perform assays in accord ance with part 147 of this subchapter. Authorized testing agent. Any person designated under § 145.11(a) to collect official samples for submission to an authorized laboratory in accordance with part 147 of this subchapter and to perform the stained antigen, rapid whole blood test for pullorum typhoid. Avian influenza. An infection or dis ease of poultry caused by viruses in the family Orthomyxoviridae, genus Influenzavirus A. 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 ba cilli, 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 poul try for slaughter only. Department. The U.S. Department of Agriculture. Domesticated. Propagated and main tained under the control of a person. Equivalent or equivalent requirements. Requirements which are equal to or ex ceed the program, conditions, criteria, or classifications with which they are compared, as determined by the Offi cial State Agency and with the concur rence of the Service. Exposed (Exposure). Contact with birds, equipment, personnel, supplies, or any article infected with, or con taminated 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 mem brane, 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 nor mally sells products under a specific strain or trade name and who author izes 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. H5/H7 low pathogenic avian influenza (LPAI). An infection of poultry caused by an influenza A virus of H5 or H7 subtype that has an intravenous patho genicity index in 6-week-old chickens less than or equal to 1.2 or causes less than 75 percent mortality in 4- to 8 week-old chickens infected intra venously, or an infection with influ enza A viruses of H5 or H7 subtype with a cleavage site that is not consistent VerDate Sep<11>2014 13:56 Feb 14, 2018 Jkt 244028 PO 00000 Frm 00896 Fmt 8010 Sfmt 8010 Q:\09\9V1.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 887 Animal and Plant Health Inspection Service, USDA § 145.1 with a previously identified highly pathogenic avian influenza virus. Hatchery. Hatchery equipment on one premises operated or controlled by any person for the production of baby poul try. Independent flock. A flock that pro duces hatching eggs and that has no ownership affiliation with a specific hatchery. Infected flock. A flock in which an au thorized laboratory has discovered one or more birds infected with a commu nicable poultry disease for which a pro gram 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 produc tion. Multiplier breeding flock. A flock that is intended for the production of hatch ing eggs used for the purpose of pro ducing progeny for commercial egg or meat production or for other non breeding purposes. NPIP Program Standards. A document that contains tests and sanitation pro cedures approved by the Administrator in accordance with § 147.53 of this sub chapter for use under this subchapter. This document may be obtained from the NPIP Web site at http:// www.aphis.usda.gov/animallhealth/ animalldislspec/poultry/ or by writing to the Service at National Poultry Im provement Plan, APHIS, USDA, 1506 Klondike Road, Suite 101, Conyers, GA 30094. NPIP Technical Committee. A com mittee made up of technical experts on poultry health, biosecurity, surveil lance, and diagnostics. The committee consists of representatives from the poultry and egg industries, univer sities, and State and Federal govern ments and is appointed by the Senior Coordinator and approved by the Gen eral Conference Committee. Official State Agency. The State au thority recognized by the Department to cooperate in the administration of the Plan. Official supervision—(1) As applied to Plan programs. The direction, inspec tion, and critical evaluation by the Of ficial State Agency of compliance with the provisions of the Plan; (2) As applied to non-Plan but equiva lent 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 im provement 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 com posed of one or more generations that is maintained for the purpose of estab lishing, continuing, or improving par ent lines. Products. Poultry breeding stock and hatching eggs, baby poultry, and start ed poultry. Program. Management, sanitation, testing, and monitoring procedures which, if complied with, will qualify, and maintain qualification for, des ignation of a flock, products produced from the flock, or a state by an official Plan classification and illustrative de sign, as described in § 145.10 of this part. Public exhibition. A public show of poultry. Pullorum disease or pullorum. A dis ease of poultry caused by Salmonella pullorum. Reactor. A bird that has a positive re action to a test, required or rec ommended in this part or in accord ance with part 147 of this subchapter, for any poultry disease for which a pro gram has been established under the Plan. Salmonella. Any bacteria belonging to the genus Salmonella, including the ar izona group. Sanitize. To treat with a product which is registered by the Environ mental Protection Agency as germi cidal, 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 VerDate Sep<11>2014 13:56 Feb 14, 2018 Jkt 244028 PO 00000 Frm 00897 Fmt 8010 Sfmt 8010 Q:\09\9V1.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 888 9 CFR Ch. I (1–1–18 Edition) § 145.2 or procedure according to its specified usage. Senior Coordinator. An employee of the Service whose duties may include, but will not necessarily be limited to: (1) Serving as executive secretary of the General Conference Committee; (2) Serving as chairperson of the Plan Conference described in § 147.47; (3) Planning, organizing, and con ducting the Plan Conference; (4) Reviewing NPIP authorized lab oratories as described in § 147.52; (5) Coordinating the State adminis tration of the NPIP through periodic reviews of the administrative proce dures of the Official State Agencies, according to the applicable provisions of the Plan and the Memorandum of Understanding; (6) Coordinating rulemaking to incor porate the proposed changes of the pro visions approved at the Plan con ference into the regulations in parts 145, 146, and 147 of this subchapter; (7) Directing the production of offi cial NPIP publications; (8) Proposing an annual budget for plan activities and the General Con ference Committee; and (9) Providing overall administration of the NPIP. Service. The Animal and Plant Health Inspection Service, Veterinary Serv ices, of the Department. Serial. The total quantity of com pleted product which has been thor oughly mixed in a single container and identified by a serial number. Sexual maturity. The average age at which a species of poultry is bio logically 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 Co lumbia, or Puerto Rico. State Inspector. Any person employed or authorized under § 145.11(b) to per form functions under this part. Stock. A term used to identify the progeny of a specific breeding combina tion within a species of poultry. These breeding combinations may include pure strains, strain crosses, breed crosses, or combinations thereof. Strain. Poultry breeding stock bear ing 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 fol lowing removal of an infected flock. Suspect flock. A flock shall be consid ered, for the purposes of the Plan, to be a suspect flock if any evidence exists that it has been exposed to a commu nicable 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. Redesignated at 44 FR 61586, Oct. 26, 1979] EDITORIAL NOTE: For FEDERAL REGISTER ci tations affecting § 145.1, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.fdsys.gov. § 145.2 Administration. (a) The Department cooperates through a Memorandum of Under standing with Official State Agencies in the administration of the Plan. In the Memorandum of Understanding, the Official State Agency must des ignate a contact representative to serve as a liaison between the Service and the Official State Agency. (b) The administrative procedures and decisions of the Official State Agency are subject to review by the Service. The Official State Agency shall carry out the administration of the Plan within the State according to the applicable provisions of the Plan and the Memorandum of Under standing. (c) An Official State Agency may ac cept 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(e), adopt regulations applicable to the administration of the Plan in such State further defining the provi sions of the Plan or establishing higher standards compatible with the Plan. (e) An authorized laboratory of the National Poultry Improvement Plan VerDate Sep<11>2014 13:56 Feb 14, 2018 Jkt 244028 PO 00000 Frm 00898 Fmt 8010 Sfmt 8010 Q:\09\9V1.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 889 Animal and Plant Health Inspection Service, USDA § 145.3 will conduct tests in accordance with part 147 of this subchapter when deter mining the status of a participating flock with respect to an official Plan classification. (Approved by the Office of Management and Budget under control number 0579–0007) [36 FR 23112, Dec. 3, 1971. Redesignated at 44 FR 61586, Oct. 26, 1979, and amended at 48 FR 57473, Dec. 30, 1983; 67 FR 8468, Feb. 25, 2002; 74 FR 14714, Apr. 1, 2009; 79 FR 38754, July 9, 2014; 81 FR 53249, Aug. 12, 2016] § 145.3 Participation. (a) The National Poultry Improve ment Plan is a cooperative Federal State-Industry program through which new or existing diagnostic technology can be effectively applied to improve poultry and poultry products by con trolling or eliminating specific poultry diseases. The Plan consists of programs that identify States, flocks, hatcheries, dealers, and slaughter plants that meet specific disease control standards spec ified in the Plan. Participants shall maintain records to demonstrate that they adhere to the disease control pro grams in which they participate. (b) Any person producing or dealing in products may participate in the Plan when he has demonstrated, to the satisfaction of the Official State Agen cy, 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 regula tions of the Official State Agency under § 145.2. Affiliated flockowners may participate without signing an agreement with the Official State Agency. (c) Each participant shall comply with the Plan throughout the oper ating year of the Official State Agency, or until released by such Agency. (d) A participant in any State shall participate with all of his poultry hatching egg supply flocks and hatch ery operations within such State. The participant shall report to the Official State Agency on VS Form 9–2 (for merly NPIP Form 3B) or through other appropriate means each breeding flock before the birds reach 24 weeks of age or, in the case of ostriches, emus, rheas, and cassowaries, before the birds reach 20 months of age. This report will include: (1) Name and address of flockowner; (2) Flock location and designation; (3) Type: Primary or Multiplier; (4) Breed, variety, strain, or trade name of stock; (5) Source of males; (6) Source of females; (7) Number of birds in the flock; and (8) Intended classification of flock. (e) To ensure that Plan diseases are not spread, flocks must be qualified for their intended Plan classifications be fore being moved into breeder produc tion facilities. (f) No person shall be compelled by the Official State Agency to qualify products for any of the other classifica tions described in § 145.10 as a condition of qualification for the U.S. Pullorum Typhoid Clean classification. (g) Participation in the Plan shall en title the participant to use the Plan emblem reproduced below: VerDate Sep<11>2014 13:56 Feb 14, 2018 Jkt 244028 PO 00000 Frm 00899 Fmt 8010 Sfmt 8010 Q:\09\9V1.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 890 9 CFR Ch. I (1–1–18 Edition) § 145.4 (Approved by the Office of Management and Budget under control number 0579–0007) [36 FR 23112, Dec. 3, 1971, as amended at 40 FR 1500, Jan. 8, 1975. Redesignated at 44 FR 61586, Oct. 26, 1979 and amended at 48 FR 57473, Dec. 30, 1983; 57 FR 57341, Dec. 4, 1992; 63 FR 40010, July 27, 1998; 65 FR 8016, Feb. 17, 2000; 79 FR 38754, July 9, 2014; 81 FR 53249, Aug. 12, 2016] § 145.4 General provisions for all par ticipants. (a) Records of purchases and sales and the identity of products handled shall be maintained in a manner satis factory to the Official State Agency. (b) Products, records of sales and pur chase 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 Agen cy 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 clas sification. (d) Except as provided by this para graph, 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 condi tions only: (1) With the permission of the Offi cial 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 partici pant and may be used on each certifi cate, invoice, shipping label, or other document used by the participant in the sale of his products. Each Official State Agency which requires an ap proval 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 quali fies for participation in the Plan. (Approved by the Office of Management and Budget under control number 0579–0057) [36 FR 23112, Dec. 3, 1971, as amended at 38 FR 13706, May 24, 1973; 41 FR 48723, Nov. 5, 1976. Redesignated at 44 FR 61586, Oct. 26, 1979, as amended at 47 FR 21991, May 20, 1982; 48 FR 57473, Dec. 30, 1983; 57 FR 57341, Dec. 4, 1992] § 145.5 Specific provisions for partici pating flocks. (a) Poultry equipment, and poultry houses and the land in the immediate vicinity thereof, shall be kept in sani tary condition in accordance with part 147 of this subchapter. The partici pating flock, its eggs, and all equip ment used in connection with the flock shall be separated from nonpartici pating flocks, in a manner acceptable to the Official State Agency. (b) All flocks shall consist of healthy, normal individuals characteristic of VerDate Sep<11>2014 13:56 Feb 14, 2018 Jkt 244028 PO 00000 Frm 00900 Fmt 8010 Sfmt 8010 Q:\09\9V1.TXT 31 EC 1 0 S E 9 1 .0 0 0 < /G P H > kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 891 Animal and Plant Health Inspection Service, USDA § 145.6 the breed, variety, cross, or other com bination which they are stated to rep resent. (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 pre scribed in Subparts B, C, D, E, F, G, H, or I 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; 79 FR 38754, July 9, 2014] § 145.6 Specific provisions for partici pating hatcheries. (a) Hatcheries must be kept in sani tary condition, acceptable to the Offi cial State Agency. The sanitary proce dures outlined in the NPIP Program Standards, or other procedures ap proved by the Administrator in accord ance with § 147.53(d), will be considered as a guide in determining compliance with this provision. The minimum re quirements with respect to sanitation include the following: (1) Egg room walls, ceilings, floors, air filters, drains, and humidifiers should be cleaned and disinfected at least two times per week. Cleaning and disinfection procedures should be in ac cordance with part 147 of this sub 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 pro cedures should be in accordance with part 147 of this subchapter. (3) Hatcher walls, ceilings, floors, doors, fans, vents, and ducts should be cleaned and disinfected after each hatch. Hatcher rooms should be cleaned and disinfected after each hatch and should not be used for stor age. Plenums should be cleaned after each hatch. Cleaning and disinfection procedures should be in accordance with part 147 of this subchapter. (4) Chick/poult processing equipment and rooms should be thoroughly cleaned and disinfected after each hatch. Chick/poult boxes should be cleaned and disinfected before being re used. Vaccination equipment should be cleaned and disinfected after each use. Cleaning and disinfection procedures should be in accordance with part 147 of this subchapter. (5) Hatchery residue, such as chick/ poult down, eggshells, infertile eggs, and dead germs, should be disposed of promptly and in a manner satisfactory to the Official State Agency. (6) The entire hatchery should be kept in a neat, orderly condition and cleaned and disinfected after each hatch. (7) Effective insect and rodent con trol programs should be implemented. (b) A hatchery that keeps started poultry must keep such poultry sepa rated from the incubator room in a manner satisfactory to the Official State Agency. (c) All baby and started poultry of fered for sale under Plan terminology should be normal and typical of the breed, variety, cross, or other combina tion 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 rep resented in the Plan disease classifica tions listed in § 145.10. (f) If a person is responsibly con nected 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 vot ing stock, or an employee in a manage rial or executive capacity. [36 FR 23112, Dec. 3, 1971. Redesignated at 44 FR 61586, Oct. 26, 1979, and amended at 49 FR 19802, May 10, 1984; 65 FR 8016, Feb. 17, 2000; 67 FR 8468, Feb. 25, 2002; 79 FR 38754, July 9, 2014] VerDate Sep<11>2014 13:56 Feb 14, 2018 Jkt 244028 PO 00000 Frm 00901 Fmt 8010 Sfmt 8010 Q:\09\9V1.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 892 9 CFR Ch. I (1–1–18 Edition) § 145.7 § 145.7 Specific provisions for partici pating dealers. Dealers in poultry breeding stock, hatching eggs, or baby or started poul try shall comply with all provisions in this part which apply to their oper ations. § 145.8 Terminology and classification; general. (a) The official classification terms defined in §§ 145.9 and 145.10 and the various designs illustrative of the offi cial classifications reproduced in § 145.10 may be used only by partici pants 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 ter minology when they are purchased for resale by or consigned to nonpartici pants. (c) Participating flocks, their eggs, and the baby and started poultry pro duced from them may be designated by their strain or trade name. When a breeder’s trade name or strain designa tion 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 multi plied by persons designated and so re ported by the breeder to each Official State Agency concerned. § 145.9 Terminology and classification; hatcheries and dealers. Participating hatcheries and dealers shall be designated as ‘‘National Plan Hatchery’’ and ‘‘National Plan Deal er’’, respectively. All Official State Agencies shall be notified by the Serv ice of additions, withdrawals, and changes in classification. [36 FR 23112, Dec. 3, 1971. Redesignated at 44 FR 61586, Oct. 26, 1979, and amended at 47 FR 21991, May 20, 1982] § 145.10 Terminology and classifica tion; flocks, products, and States. Participating flocks, products pro duced from them, and States that have met the requirements of a classifica tion in this part may be designated by the corresponding illustrative design in this section. (a) [Reserved] (b) U.S. Pullorum-Typhoid Clean. (See § 145.23(b), § 145.33(b), § 145.43(b), §§ 145.53(b), 145.63(a), 145.73(b), 145.83(b), and 145.93(b).) (c) U.S. M. Gallisepticum Clean. (See §§ 145.23(c), 145.23(f), 145.33(c), 145.33(f), 145.43(c), 145.53(c), 145.73(c), and 145.83(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)). VerDate Sep<11>2014 13:56 Feb 14, 2018 Jkt 244028 PO 00000 Frm 00902 Fmt 8010 Sfmt 8010 Q:\09\9V1.TXT 31 EC 1 0 S E 9 1 .0 0 2 < /G P H > E C 1 0 S E 9 1 .0 0 3 < /G P H > E C 1 0 S E 9 1 .0 0 4 < /G P H > kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 893 Animal and Plant Health Inspection Service, USDA § 145.10 (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), 145.54(a), and 145.94(a).) (h) U.S. Pullorum-Typhoid Clean State, Turkeys. (See § 145.44(b).) VerDate Sep<11>2014 13:56 Feb 14, 2018 Jkt 244028 PO 00000 Frm 00903 Fmt 8010 Sfmt 8010 Q:\09\9V1.TXT 31 EC 1 0 S E 9 1 .0 0 5 < /G P H > E C 1 0 S E 9 1 .0 0 6 < /G P H > E R 2 1 M R 9 6 .0 0 0 < /G P H > kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 894 9 CFR Ch. I (1–1–18 Edition) § 145.10 (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).) VerDate Sep<11>2014 13:56 Feb 14, 2018 Jkt 244028 PO 00000 Frm 00904 Fmt 8010 Sfmt 8010 Q:\09\9V1.TXT 31 ER 2 1 M R 9 6 .0 0 1 < /G P H > E C 1 0 S E 9 1 .0 0 9 < /G P H > E C 1 0 S E 9 1 .0 1 0 < /G P H > kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 895 Animal and Plant Health Inspection Service, USDA § 145.10 FIGURE 12 (l) [Reserved] (m) U.S. S. Enteritidis Clean. (See §§ 145.23(d), 145.73(d), and 145.83(e).) (n) U.S. M. Synoviae Clean State, Tur keys. (See § 145.44(d).) (o) U.S. Salmonella Monitored. (See §§ 145.53(f), 145.83(f), and 145.93(d).) (p) U.S. M. Gallisepticum Monitored. (See § 145.33(j).) VerDate Sep<11>2014 13:56 Feb 14, 2018 Jkt 244028 PO 00000 Frm 00905 Fmt 8010 Sfmt 8010 Q:\09\9V1.TXT 31 EC 1 0 S E 9 1 .0 1 1 E R 2 1 M R 9 6 .0 0 2 < /G P H > E R 2 1 M R 9 6 .0 0 3 < /G P H > E R 1 9 A U 9 7 .0 0 0 < /G P H > kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 896 9 CFR Ch. I (1–1–18 Edition) § 145.10 (q) U.S. M. Synoviae Monitored. (See § 145.33(k).) (r) U.S. Avian Influenza Clean. (See §§ 145.23(h), 145.33(l), 145.63(b), 145.73(f), and 145.83(g).) (s) U.S. M. Meleagridis Clean State, Turkeys. (See § 145.44(e).) VerDate Sep<11>2014 13:56 Feb 14, 2018 Jkt 244028 PO 00000 Frm 00906 Fmt 8010 Sfmt 8010 Q:\09\9V1.TXT 31 ER 1 9 A U 9 7 .0 0 1 < /G P H > E R 1 9 A U 9 7 .0 0 2 < /G P H > E R 1 7 F E 0 0 .0 1 3 < /G P H > kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 897 Animal and Plant Health Inspection Service, USDA § 145.10 VerDate Sep<11>2014 13:56 Feb 14, 2018 Jkt 244028 PO 00000 Frm 00907 Fmt 8010 Sfmt 8010 Q:\09\9V1.TXT 31 ER 1 7 F E 0 0 .0 0 8 < /G P H > kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 898 9 CFR Ch. I (1–1–18 Edition) § 145.11 (t) U.S. H5/H7 Avian Influenza Clean. (See §§ 145.43(g), 145.53(e), and 145.93(c).) [38 FR 13706, May 24, 1973. Redesignated at 44 FR 61586, Oct. 26, 1979] EDITORIAL NOTE: For FEDERAL REGISTER ci tations affecting § 145.10, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.fdsys.gov. § 145.11 Supervision. (a) The Official State Agency may designate qualified persons as Author ized Agents to do the sample collecting provided for in § 145.14 and may des ignate qualified persons as Authorized Testing Agents to do the sample col lecting and blood testing provided for in § 145.14. (b) The Official State Agency shall employ or authorize qualified persons as State Inspectors to perform the qualification testing of participating flocks, and to perform the official in spections necessary to verify compli ance with the requirements of the Plan. (c) Authorities issued under the pro visions of this section shall be subject to cancellation by the official State agency on the grounds of incompetence or failure to comply with the provi sions of the Plan or regulations of the official State agency. Such actions shall not be taken until a thorough in vestigation has been made by the offi cial State agency and the authorized person has been given notice of the pro posed action and the basis therefor and an opportunity to present his views. [36 FR 23112, Dec. 3, 1971, as amended at 38 FR 13706, May 24, 1973; 41 FR 48723, Nov. 5, 1976. Redesignated at 44 FR 61586, Oct. 26, 1979, as amended at 72 FR 1418, Jan. 12, 2007] § 145.12 Inspections. (a) Each participating hatchery shall be audited at least one time annually or a sufficient number of times each year to satisfy the Official State Agen cy that the operations of the hatchery are in compliance with the provisions of the Plan. (b) The records of all flocks main tained primarily for production of hatching eggs shall be made available to and examined annually by a State Inspector. Records shall include VS Form 9–2, ‘‘Flock Selecting and Test ing Report’’; VS Form 9–3, ‘‘Report of Sales of Hatching Eggs, Chicks, and Poults’’; set and hatch records; egg re ceipts; and egg/chick orders or in voices. Records shall be maintained for 3 years. On-site inspections of flocks and premises will be conducted if the State Inspector determines that a breach of sanitation, blood testing, or other provisions has occurred for Plan programs for which the flocks have or are being qualified. [36 FR 23112, Dec. 3, 1971, as amended at 40 FR 1501, Jan. 8, 1975. Redesignated at 44 FR 61586, Oct. 26, 1979, and amended at 54 FR 23955, June 5, 1989; 59 FR 12798, Mar. 18, 1994; 72 FR 1418, Jan. 12, 2007; 81 FR 53249, Aug. 12, 2016] § 145.13 Debarment from participation. Participants in the Plan, who after investigation by the Official State Agency or its representative, are noti fied in writing of their apparent non compliance with the Plan provisions or regulations of the Official State Agen cy, shall be afforded a reasonable time, as specified by the Official State Agen cy, 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 VerDate Sep<11>2014 13:56 Feb 14, 2018 Jkt 244028 PO 00000 Frm 00908 Fmt 8010 Sfmt 8010 Q:\09\9V1.TXT 31 ER 1 4 N O 0 3 .0 0 0 < /G P H > kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 899 Animal and Plant Health Inspection Service, USDA § 145.14 1 The criteria and procedures for Depart ment approval of antigens and reagents may be obtained from the Animal and Plant Health Inspection Service, Veterinary Serv ices, Center for Veterinary Biologics, 510 South 17th Street, Suite 104, Ames, IA 50010– 8197. notice of the bases for the debarment and opportunity to present his views with respect to the debarment in ac cordance with procedures adopted by the Official State Agency. The Official State Agency shall thereupon decide whether the debarment order shall con tinue in effect. Such decision shall be final unless the debarred participant, within 30 days after the issuance of the debarment order, requests the Admin istrator to determine the eligibility of the debarred participant for participa tion in the Plan. In such event the Ad ministrator 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 Adminis trator, Animal and Plant Health In spection Service of the U.S. Depart ment of Agriculture or any officer or employee to whom authority has here tofore been delegated or to whom au thority 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] § 145.14 Testing. Poultry must be more than 4 months of age when tested for an official clas sification: Provided, That turkey can didates under subpart D of this part may be tested at more than 12 weeks of age; game bird candidates under sub part E of this part may be tested when more than 4 months of age or upon reaching sexual maturity, whichever comes first; and ostrich, emu, rhea, and cassowary candidates under subpart F of this part may be tested when more than 12 months of age. Samples for offi cial tests shall be collected by an Au thorized Agent, Authorized Testing Agent, or State Inspector and tested by an authorized laboratory, except that the stained antigen, rapid whole-blood test for pullorum-typhoid may be con ducted by an Authorized Testing Agent or State Inspector. For Plan programs in which a representative sample may be tested in lieu of an entire flock, ex cept the ostrich, emu, rhea, and casso wary program in § 145.63(a), the min imum 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, exhi bition 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 other than ostriches, emus, rheas, and casso waries, all birds in the house must be tested. (a) For Pullorum-Typhoid. (1) The offi cial blood tests for pullorum-typhoid shall be the standard tube agglutina tion 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. Official blood tests must be conducted in accordance with part 147 of this subchapter or ac cording to 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 there after as long as antigen from that se rial continues to be made available for use. All microtest antigens and en zyme-linked immunosorbent assay re agents shall also be approved by the Department. 1 (2) [Reserved] (3) There shall be an interval of at least 21 days between any official blood test and any previous test with pul lorum-typhoid antigen. (4) [Reserved] (5) The official blood test shall in clude the testing of a sample of blood from each bird in the flock: Provided, That under specified conditions (see VerDate Sep<11>2014 13:56 Feb 14, 2018 Jkt 244028 PO 00000 Frm 00909 Fmt 8010 Sfmt 8010 Q:\09\9V1.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 900 9 CFR Ch. I (1–1–18 Edition) § 145.14 2 In making determinations of exposure, the State Inspector shall evaluate both evi dence proving that exposure occurred and circumstances indicating a high probability of contacts with: infected wild birds; con taminated feed or waste; or birds, equip ment, supplies, or persons from or exposed to flocks infected with S. pullorum or S. gallinarum. applicable provisions of §§ 145.23, 145.33, 145.43, 145.53, 145.63, 145.73, 145.83, and 145.93) the testing of a portion or sam ple 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 reac tion to an official blood test named in paragraph (a)(1) of this section shall be evaluated for pullorum-typhoid as fol lows: (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 microaggluti nation test. (ii) Reactors to the standard tube ag glutination 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 labora tory; if the flock has four or fewer re actors, all of the reactors must be sub mitted. Bacteriological examination must be conducted in accordance with part 147 of this subchapter. When reac tors 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 in fection, the Official State Agency shall presume that the flock has no pul lorum-typhoid reactors. (iii) If a flock owner does not wish to submit reactors for bacteriological ex amination, 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 examina tion of the reactors and flock will be performed in accordance with para graph (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 phys ical contact with other birds and as sure that personnel, equipment, and supplies that could be a source of pul lorum-typhoid spread are sanitized. (7) When S. pullorum or S. gallinarum organisms are isolated by an author ized laboratory from baby poultry, or from fluff samples produced by hatch ing eggs, the infected flock shall qual ify 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 participa tion 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 in clude 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 In spector; Provided, That at the discre tion 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 ex posed to S. pullorum or S. gallinarum, 2 the Official State Agency shall require: (i) The taking of blood samples—per formed 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 su pervised 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 offi cial blood test named in paragraph (a)(1) of this section. VerDate Sep<11>2014 13:56 Feb 14, 2018 Jkt 244028 PO 00000 Frm 00910 Fmt 8010 Sfmt 8010 Q:\09\9V1.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 901 Animal and Plant Health Inspection Service, USDA § 145.14 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, ‘‘Ap plication of Enzyme-Linked Immunosorbent Assay for Detecting Antibody to Myco plasma gallisepticum Infections in Poultry,’’ Avian Diseases, Vol. 27, No. 1, pp. 21–35, Janu ary-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, ‘‘Myco plasma Meleagridis Antibody Detection by Enzyme-Linked Immunosorbent Assay (ELISA),’’ Proceedings, 30th Western Poultry Disease Conference, pp. 63–66, March 1981. (8) All domesticated fowl, except wa terfowl, on the farm of the participant shall either be properly tested to meet the same standards as the partici pating flock or these birds and their eggs shall be separated from the par ticipating 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 comple tion of such tests. All reactors shall be considered in determining the classi fication of the flock. (10) Any drug, for which there is sci entific evidence of masking the test re action 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 deter mined by the Official State Agency or the State Animal Disease Control Offi cial, 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 re qualified under the requirements for the classification. Furthermore, the Of ficial State Agency may require that the hatching eggs from such flocks be removed from the incubator and de stroyed prior to hatching. When Sal monella organisms are isolated from a specimen which originated in a partici pating 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 re ported by the Official State Agency to the Service. (b) For Mycoplasma gallisepticum, M. meleagridis, and M. synoviae. (1) The of ficial tests for M. gallisepticum, M. meleagridis, and M. synoviae shall be the serum plate agglutination test, the hemagglutination inhibition (HI) test, the enzyme-linked immunosorbent assay (ELISA) test,3 or a molecular based test. The HI test or molecular based test shall be used to confirm the positive results of other serological screening tests. HI titers of 1:40 or more may be interpreted as suspicious, and final judgment must be based on further samplings and/or culture of re actors. Tests must be conducted in ac cordance with this paragraph (b) and in accordance with part 147 of this sub chapter. (2) The serological tests shall be con ducted using M. gallisepticum, M. meleagridis, or M. synoviae antigens ap proved by the Department or the Offi cial State Agency and shall be per formed in accordance with the rec ommendations of the producer of the antigen. (3) When reactors to the test for which the flock was tested are sub mitted to a laboratory as prescribed by the Official State Agency, the final status of the flock will be determined in accordance with part 147 of this sub chapter. (4) Any drug, for which there is sci entific evidence of masking the test re action 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 classifica tion is based. (5) The official molecular examina tion procedures for M. gallisepticum are VerDate Sep<11>2014 13:56 Feb 14, 2018 Jkt 244028 PO 00000 Frm 00911 Fmt 8010 Sfmt 8010 Q:\09\9V1.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 902 9 CFR Ch. I (1–1–18 Edition) § 145.15 the PCR test described in § 147.30 of this subchapter and the real-time PCR test described in § 147.31 of this subchapter. The official molecular examination procedure for M. synoviae is the PCR test described in § 147.30 of this sub chapter. (c) [Reserved] (d) For avian influenza. The official tests for avian influenza are described in paragraphs (d)(1) and (d)(2) of this section. (1) Antibody detection tests—(i) En zyme-linked immunosorbent assay (ELISA). ELISA must be conducted using test kits approved by the Depart ment and the Official State Agency and must be conducted in accordance with the recommendations of the producer or manufacturer. (ii) The agar gel immunodiffusion (AGID) test. (A) The AGID test must be conducted on all ELISA-positive sam ples. (B) The AGID test must be conducted using reagents approved by the Depart ment and the Official State Agency. (C) The AGID test for avian influenza must be conducted in accordance with part 147 of this subchapter. The test can be conducted on egg yolk or blood samples. The AGID test is not rec ommended for use in waterfowl. (D) Positive tests for the AGID must be further tested by Federal Reference Laboratories using appropriate tests for confirmation. Final judgment may be based upon further sampling and ap propriate tests for confirmation. (2) Agent detection tests. Agent detec tion tests may be used to detect influ enza A matrix gene or protein but not to determine hemagglutinin or neuraminidase subtypes. Samples for agent detection testing should be col lected from naturally occurring flock mortality or clinically ill birds. (i) The real time reverse transcriptase/ polymerase chain reaction (RRT–PCR) assay. (A) The RRT–PCR tests must be conducted using reagents approved by the Department and the Official State Agency. The RRT–PCR must be con ducted using the National Veterinary Services Laboratories (NVSL) official protocol for RRT–PCR and must be conducted by personnel who have passed an NVSL proficiency test. (B) Positive results from the RRT– PCR must be further tested by Federal Reference Laboratories using appro priate tests for confirmation. Final judgment may be based upon further sampling and appropriate tests for con firmation. (ii) USDA-licensed type A influenza antigen capture immunoassay (ACIA). (A) The USDA-licensed type A influenza ACIA must be conducted using test kits approved by the Department and the Official State Agency and must be conducted in accordance with the rec ommendations of the producer or man ufacturer. (B) Chicken and turkey flocks that test positive on the ACIA must be fur ther tested using the RRT–PCR or virus isolation. Positive results from the RRT–PCR or virus isolation must be further tested by Federal Reference Laboratories using appropriate tests for confirmation. Final judgment may be based upon further sampling and ap propriate tests for confirmation. (3) The official determination of a flock as positive for the H5 or H7 subtypes of avian influenza may be made only by NVSL. (Approved by the Office of Management and Budget under control number 0579–0007) [36 FR 23112, Dec. 3, 1971] EDITORIAL NOTE: For FEDERAL REGISTER ci tations affecting § 145.14, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.fdsys.gov. § 145.15 Diagnostic surveillance pro gram for low pathogenic avian in fluenza. (a) The Official State Agency must develop a diagnostic surveillance pro gram for H5/H7 low pathogenic avian influenza for all poultry in the State. The exact provisions of the program are at the discretion of the States. The Service will use the standards in para graph (b) of this section in assessing in dividual State plans for adequacy, in cluding the specific provisions that the State developed. The standards should be used by States in developing those plans. (b) Avian influenza must be a disease reportable to the responsible State au thority (State veterinarian, etc.) by all licensed veterinarians. To accomplish VerDate Sep<11>2014 13:56 Feb 14, 2018 Jkt 244028 PO 00000 Frm 00912 Fmt 8010 Sfmt 8010 Q:\09\9V1.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 903 Animal and Plant Health Inspection Service, USDA § 145.23 this, all laboratories (private, State, and university laboratories) that per form diagnostic procedures on poultry must examine all submitted cases of unexplained respiratory disease, egg production drops, and mortality for avian influenza by both an approved se rological test and an approved antigen detection test. Memoranda of under standing or other means must be used to establish testing and reporting cri teria (including criteria that provide for reporting H5 and H7 low pathogenic avian influenza directly to the Service) and approved testing methods. In addi tion, States should conduct outreach to poultry producers, especially owners of smaller flocks, regarding the impor tance of prompt reporting of clinical symptoms consistent with avian influ enza. [74 FR 14715, Apr. 1, 2009] Subpart B—Special Provisions for Multiplier Egg-Type Chicken Breeding Flocks and Prod ucts § 145.21 Definitions. Except where the context otherwise requires, for the purposes of this sub part the following terms shall be con strued, 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 ul timate 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] § 145.22 Participation. Participating flocks of multiplier egg type chickens, and the eggs and chicks produced from them, shall comply with the applicable general provisions of subpart A of this part and the special provisions of this subpart B. (a) Started chickens shall lose their identity under Plan terminology when not maintained by Plan participants under the conditions prescribed in § 145.5(a). (b) Hatching eggs produced by multi plier breeding flocks should be nest clean. They may be fumigated in ac cordance with part 147 of this sub chapter or otherwise sanitized. (c) Any nutritive material provided to chicks must be free of the avian pathogens that are officially rep resented in the Plan disease classifica tions listed in § 145.10. [36 FR 23112, Dec. 3, 1971, as amended at 40 FR 1501, Jan. 8, 1975. Redesignated at 44 FR 61586, Oct. 26, 1979, and amended at 49 FR 19802, May 10, 1984; 57 FR 57341, Dec. 4, 1992; 65 FR 8017, Feb. 17, 2000; 68 FR 64510, Nov. 14, 2003; 72 FR 1419, Jan. 12, 2007; 79 FR 38755, July 9, 2014] § 145.23 Terminology and classifica tion; flocks and products. Participating flocks, and the eggs and chicks produced from them, which have met the respective requirements specified in this section may be des ignated 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 cri teria in one of the following paragraphs (b)(1) through (4) of this section: Pro vided, That a flock qualifying by means of a blood test shall be tested within the past 12 months, except that the re testing 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 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 Offi cial State Agency within 48 hours the VerDate Sep<11>2014 13:56 Feb 14, 2018 Jkt 244028 PO 00000 Frm 00913 Fmt 8010 Sfmt 8010 Q:\09\9V1.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 904 9 CFR Ch. I (1–1–18 Edition) § 145.23 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. Pul lorum-Typhoid Clean breeding flocks or from flocks that met equivalent re quirements under official supervision; and (iii) The flock is located on a prem ises where a flock not classified as U.S. Pullorum-Typhoid Clean was located the previous year; Provided, That an Authorized Testing Agent must blood test up to 300 birds per flock, as de scribed 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 per formed 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 qualifica tion 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 require ments 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 Hatch eries’’ or have met equivalent require ments for pullorum-typhoid control under official supervision; (ii) All hatchery supply flocks within the State, are qualified as U.S. Pul lorum-Typhoid Clean or have met equivalent requirements for pullorum typhoid control under official super vision: Provided, That if other domes ticated 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 prohib ited; (iv) All persons performing poultry disease diagnostic services within the State are required to report to the Offi cial 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 out break 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 Im provement Plan will conduct an inves tigation; (vi) All flocks found to be infected with pullorum or typhoid are quar antined 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 dem onstrate pullorum or typhoid infection; (vii) All poultry, including exhi bition, exotic, and game birds, but ex cluding waterfowl, going to public ex hibition shall come from U.S. Pul lorum-Typhoid Clean or equivalent flocks, or have had a negative pul lorum-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 oc currence of repeated outbreaks of pul lorum 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 in vestigation has been made by the Serv ice 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 de termined by the Service to be in com pliance with the provisions of (b)(3) of this section, and in which pullorum VerDate Sep<11>2014 13:56 Feb 14, 2018 Jkt 244028 PO 00000 Frm 00914 Fmt 8010 Sfmt 8010 Q:\09\9V1.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 905 Animal and Plant Health Inspection Service, USDA § 145.23 disease or fowl typhoid is not known to exist nor to have existed in hatchery supply flocks within the State during the preceding 12 months. (c) U.S. M. Gallisepticum Clean. (1) A flock maintained in accordance with part 147 of this subchapter with respect to Mycoplasma isolation, sanitation, and management and in which freedom from M. gallisepticum has been dem onstrated under the criteria specified in paragraph (c)(1)(i) or (ii) of this sec tion. (i) [Reserved] (ii) It is a multiplier breeding flock which originated as U.S. M. Gallisepticum Clean chicks from pri mary 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: Pro vided, That to retain this classifica tion, 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 pro duced 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 con ducted in accordance with part 147 of this subchapter. (2) A participant handling U.S. M. Gallisepticum Clean products shall keep these products separate from other products in a manner satisfac tory to the Official State Agency. (3) U.S. M. Gallisepticum Clean chicks shall be boxed in clean boxes and delivered in trucks that have been cleaned and disinfected in accordance with part 147 of this subchapter. (d) U.S. S. Enteritidis Clean. This clas sification is intended for egg-type breeders wishing to assure their cus tomers 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 de termined 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 bacterio logically for salmonella at an author ized 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 ei ther 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 manufac tured in pellet form and crumbled: Pro vided, that mash feed may contain nonpelleted APPI animal protein prod uct supplements if the finished feed is treated with a salmonella control prod uct approved by the Food and Drug Ad ministration. (iii) Feed shall be stored and trans ported in such a manner as to prevent possible contamination; (iv) The flock is maintained in ac cordance with part 147 of this sub chapter with respect to flock sanita tion, cleaning and disinfection, and Salmonella isolation, sanitation, and management. Rodents and other pests should be effectively controlled; (v) Environmental samples shall be collected from the flock by an Author ized Agent, in accordance with part 147 of this subchapter, when the flock is 2 to 4 weeks of age. The samples shall be examined bacteriologically for group D salmonella at an authorized labora tory. Cultures from positive samples shall be serotyped. The authorized VerDate Sep<11>2014 13:56 Feb 14, 2018 Jkt 244028 PO 00000 Frm 00915 Fmt 8010 Sfmt 8010 Q:\09\9V1.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 906 9 CFR Ch. I (1–1–18 Edition) § 145.23 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 pul lorum-typhoid antigen, one of the fol lowing options must be utilized: (A) Administer the vaccine after the pullorum-typhoid testing is done as de scribed 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 de scribed in paragraph (d)(1)(vii) of this section, vaccinate the banded, non-vac cinated birds. (vii) Blood samples from 300 non-vac cinated 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 incon clusive reactions, up to a maximum of 25 birds, shall be submitted to an au thorized laboratory and examined for the presence of group D salmonella, in accordance with part 147 of this sub chapter. Cultures from positive sam ples shall be serotyped. (viii) Hatching eggs are collected as quickly as possible, and their sanita tion is maintained in accordance with part 147 of this subchapter. (ix) Hatching eggs produced by the flock are incubated in a hatchery whose sanitation is maintained in ac cordance with part 147 of this sub chapter and sanitized either by a proce dure approved by the Official State Agency or in accordance with part 147 of this subchapter. (2) A flock shall not be eligible for this classification if Salmonella enteritidis ser enteritidis (SE) is isolated from a specimen taken from a bird in the flock. Isolation of SE from an envi ronmental or other specimen, as de scribed in paragraph (d)(1)(v) of this section, will require bacteriological ex amination for SE in an authorized lab oratory, in accordance with part 147 of this subchapter, 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 bacterio logical examination of a second sam ple, equal in size to the first sample, from the flock. If no SE is recovered from any of the specimens in the sec ond sample, the flock will be eligible for the classification. (3) A non-vaccinated flock shall be el igible for this classification if Sal monella enteritidis (S. enteritidis ser Enteritidis) is isolated from an envi ronmental 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 prod ucts handled shall meet the require ments of the classification. (5) This classification may be re voked by the Official State Agency if the participant fails to follow rec ommended corrective measures. (e) U.S.M. Synoviae Clean. (1) A flock maintained in accordance with part 147 of this subchapter with respect to Mycoplasma isolation, sanitation, and management and in which freedom from M. synoviae has been dem onstrated under the criteria specified in paragraph (e)(1)(i) or (ii) of this sec tion. (i) [Reserved] (ii) It is a multiplier breeding flock which originated as U.S. M. Synoviae Clean chicks from primary breeding flocks and from which a sample com prised 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 sub jected to one of the following proce dures: (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 VerDate Sep<11>2014 13:56 Feb 14, 2018 Jkt 244028 PO 00000 Frm 00916 Fmt 8010 Sfmt 8010 Q:\09\9V1.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 907 Animal and Plant Health Inspection Service, USDA § 145.23 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 con ducted in accordance with part 147 of this subchapter. (2) A participant handling U.S. M. Synoviae Clean products shall keep these products separate from other products in a manner satisfactory to the Official State Agency. (3) U.S. M. Synoviae Clean chicks shall be boxed in clean boxes and deliv ered in trucks that have been cleaned and disinfected in accordance with part 147 of this subchapter. (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 accord ance with part 147 of this subchapter with respect to Mycoplasma isolation, sanitation, and management. (4) The flock’s freedom from M. Gallisepticum is demonstrated by a neg ative 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 in accordance with part 147 of this subchapter. (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 accord ance with part 147 of this subchapter with respect to Mycoplasma isolation, sanitation, and management. (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 in accordance with part 147 of this subchapter. (h) U.S. Avian Influenza Clean. This program is intended to be the basis from which the breeding-hatchery in dustry may conduct a program for the prevention and control of avian influ enza. It is intended to determine the presence of avian influenza in breeding chickens through routine surveillance of each participating breeding flock. A flock and the hatching eggs and chicks produced from it will qualify for this classification when the Official State Agency determines that they have met the following requirements: (1) It is a multiplier breeding flock in which a minimum of 30 birds have been tested and found negative to avian in fluenza 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 nega tive, at any one time if all pens are equally represented and a total of 30 birds is tested within each 90-day pe riod; or (iii) The flock is tested as provided in § 145.14(d) at intervals of 30 days or less and found to be negative, and a total of 30 samples are collected and tested within each 90-day period; and (2) A sample of at least 11 birds must be tested and found negative to avian influenza within 21 days prior to slaughter. (Approved by the Office of Management and Budget under control number 0579–0007) [36 FR 23112, Dec. 3, 1971] EDITORIAL NOTE: For FEDERAL REGISTER ci tations affecting § 145.23, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.fdsys.gov. VerDate Sep<11>2014 13:56 Feb 14, 2018 Jkt 244028 PO 00000 Frm 00917 Fmt 8010 Sfmt 8010 Q:\09\9V1.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 908 9 CFR Ch. I (1–1–18 Edition) § 145.24 § 145.24 Terminology and classifica tion; States. (a) U.S. Pullorum-Typhoid Clean State. (1) A State will be declared a U.S. Pul lorum-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), § 145.53(b)(3)(i) through (vii), § 145.73(b)(2)(i), § 145.83(b)(2)(i), and § 145.93(b)(3)(i) through (vii). (ii) No pullorum disease or fowl ty phoid is known to exist nor to have ex isted in hatchery supply flocks within the State during the preceding 12 months: Provided, That pullorum dis ease or fowl typhoid found within the preceding 24 months in waterfowl, exhi bition poultry, and game bird breeding flocks will not prevent a State, which is otherwise eligible, from qualifying. (2) Discontinuation of any of the con ditions described in paragraph (a)(1)(i) of this section, or repeated outbreaks of pullorum or typhoid occur in hatch ery supply flocks described in para graph (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 classi fication. 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 accord ance with rules of practice adopted by the Administrator. (b) [Reserved] [40 FR 1502, Jan. 8, 1975. Redesignated at 44 FR 61586, Oct. 26, 1979, and amended at 54 FR 23957, June 5, 1989; 67 FR 8469, Feb. 25, 2002; 72 FR 1419, Jan. 12, 2007; 76 FR 15793, Mar. 22, 2011] Subpart C—Special Provisions for Multiplier Meat-Type Chicken Breeding Flocks and Prod ucts § 145.31 Definitions. Except where the context otherwise requires, for the purposes of this sub part the following terms shall be con strued, 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 ul timate 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] § 145.32 Participation. Participating flocks of multiplier meat type chickens, and the eggs and chicks produced from them, shall com ply with the applicable general provi sions 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 multi plier breeding flocks should be nest clean. They may be fumigated in ac cordance with part 147 of this sub chapter or otherwise sanitized. (c) Any nutritive material provided to chicks must be free of the avian pathogens that are officially rep resented in the Plan disease classifica tions listed in § 145.10. [36 FR 23112, Dec. 3, 1971, as amended at 40 FR 1502, Jan. 8, 1975; 41 FR 48724, Nov. 5, 1976. Redesignated at 44 FR 61586, Oct. 26, 1979, and amended at 49 FR 19802, May 10, 1984; 57 FR 57341, Dec. 4, 1992; 65 FR 8018, Feb. 17, 2000; 68 FR 64510, Nov. 14, 2003; 72 FR 1419, Jan. 12, 2007; 79 FR 38756, July 9, 2014] § 145.33 Terminology and classifica tion; flocks and products. Participating flocks, and the eggs and chicks produced from them, which have met the respective requirements specified in this section may be des ignated 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 VerDate Sep<11>2014 13:56 Feb 14, 2018 Jkt 244028 PO 00000 Frm 00918 Fmt 8010 Sfmt 8010 Q:\09\9V1.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 909 Animal and Plant Health Inspection Service, USDA § 145.33 the official State agency under the cri teria in one of paragraphs (b)(1) through (4) 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 re testing 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 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 Offi cial 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. Pul lorum-Typhoid Clean breeding flocks or from flocks that met equivalent re quirements under official supervision; and (iii) The flock is located on a prem ises where a flock not classified as U.S. Pullorum-Typhoid Clean was located the previous year; Provided, That an Authorized Testing Agent must blood test up to 300 birds per flock, as de scribed 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 per formed 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 qualifica tion 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 require ments 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 Hatch eries’’ or have met equivalent require ments for pullorum-typhoid control under official supervision; (ii) All hatchery supply flocks within the State, are qualified as U.S. Pul lorum-Typhoid Clean or have met equivalent requirements for pullorum typhoid control under official super vision: Provided, That if other domes ticated 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 prohib ited; (iv) All persons performing poultry disease diagnostic services within the State are required to report to the Offi cial 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 out break 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 Im provement Plan will conduct an inves tigation; (vi) All flocks found to be infected with pullorum or typhoid are quar antined 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 dem onstrate pullorum or typhoid infection; (vii) All poultry, including exhi bition, exotic, and game birds, but ex cluding waterfowl, going to public ex hibition shall come from U.S. Pul lorum-Typhoid Clean or equivalent VerDate Sep<11>2014 13:56 Feb 14, 2018 Jkt 244028 PO 00000 Frm 00919 Fmt 8010 Sfmt 8010 Q:\09\9V1.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 910 9 CFR Ch. I (1–1–18 Edition) § 145.33 flocks, or have had a negative pul lorum-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 oc currence of repeated outbreaks of pul lorum 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 in vestigation has been made by the Serv ice 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 de termined by the Service to be in com pliance with the provisions of para graph (b)(3) of this section, and in which pullorum disease or fowl typhoid is not known to exist nor to have ex isted in hatchery supply flocks within the State during the preceding 12 months. (c) U.S. M. Gallisepticum Clean. (1) A flock maintained in accordance with part 147 of this subchapter with respect to Mycoplasma isolation, sanitation, and management and in which freedom from M. gallisepticum has been dem onstrated under the criteria specified in paragraph (c)(1)(i) or (ii) of this sec tion. (i) [Reserved] (ii) It is a multiplier breeding flock which originated as U.S. M. Gallisepticum Clean chicks from pri mary 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: Pro vided, That to retain this classifica tion, 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 pro duced 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 con ducted in accordance with part 147 of this subchapter. (2) A participant handling U.S. M. Gallisepticum Clean products must keep these products separate from other products through the use of sepa rate hatchers and incubators, separate hatch days, and proper hatchery sani tation and biosecurity in a manner sat isfactory to the Official State Agency and in accordance with part 147 of this subchapter. (3) U.S. M. Gallisepticum Clean chicks shall be boxed in clean boxes and delivered in trucks that have been cleaned and disinfected in accordance with part 147 of this subchapter. (4) Before male breeding birds may be added to a participating multiplier breeding flock, a sample of at least 30 birds to be added, with a minimum of 10 birds per pen, shall be tested for M. gallisepticum as provided in § 145.14(b), or by a polymerase chain reaction (PCR)-based procedure in accordance with part 147 of this subchapter. If fewer than 30 male breeding birds are being added, all the birds shall be test ed 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 de stroyed. (d) U.S. Sanitation Monitored. This program is intended to be the basis from which the breeding-hatching in dustry may conduct a program for the prevention and control of Salmonel losis. It is intended to reduce the inci dence of Salmonella organisms in hatching eggs and chicks through an effective and practical sanitation pro gram at the breeder farm and in the VerDate Sep<11>2014 13:56 Feb 14, 2018 Jkt 244028 PO 00000 Frm 00920 Fmt 8010 Sfmt 8010 Q:\09\9V1.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 911 Animal and Plant Health Inspection Service, USDA § 145.33 4 Preparation and use of this type of vac cine may be regulated by State statutes. hatchery. This will afford other seg ments of the poultry industry an op portunity 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 de termined by the Official State Agency: (i) The flock shall originate from a source where sanitation and manage ment practices, as outlined in § 145.33(d)(1) of this paragraph, are con ducted; (ii) The flock is maintained in ac cordance with part 147 of this sub chapter with respect to flock sanita tion, cleaning and disinfection, and Salmonella isolation, sanitation, and management; (iii) If pelletized feed contains animal protein, the protein products shall be purchased from participants in the Animal Protein Products Industry (APPI) Salmonella Education/Reduction Program or the Fishmeal Inspection Program of the National Marine Fish eries Service. The protein products must have a minimum moisture con tent of 14.5 percent and must have been heated throughout to a minimum tem perature of 190 °F. or above, or to a minimum temperature of 165 °F. for at least 20 minutes, or to a minimum tem perature of 184 °F. under 70 lbs. pres sure during the manufacturing process; (iv) If mash feed contains animal pro tein, the protein products shall be pur chased from participants in the Animal Protein Products Industry (APPI) Sal monella Education/Reduction Program or the Fishmeal Inspection Program of the National Marine Fisheries Service; (v) Feed shall be stored and trans ported in such a manner as to prevent possible contamination; (vi) Chicks shall be hatched in a hatchery whose sanitation is main tained in accordance with part 147 of this subchapter and sanitized or fumi gated in accordance with part 147 of this subchapter; (vii) An Authorized Agent shall take environmental samples, in accordance with part 147 of this subchapter, from each flock at 4 months of age and every 90 days thereafter. An authorized lab oratory for Salmonella shall examine the environmental samples bacterio logically; (viii) Owners of flocks found infected with a paratyphoid Salmonella may vac cinate these flocks with an autogenous bacterin with a potentiating agent. 4 (2) The Official State Agency may monitor the effectiveness of the sanita tion practices in accordance with part 147 of this subchapter. (3) In order for a hatchery to sell products of this classification, all prod ucts handled shall meet the require ments of the classification. (4) This classification may be re voked by the Official State Agency if the participant fails to follow rec ommended corrective measures. (e) U.S. M. Synoviae Clean. (1) A flock maintained in accordance with part 147 of this subchapter with respect to Mycoplasma isolation, sanitation, and management and in which freedom from M. synoviae has been dem onstrated under the criteria specified in paragraph (e)(1)(i) or (ii) of this sec tion. (i) [Reserved] (ii) It is a multiplier breeding flock which originated as U.S. M. Synoviae Clean chicks from primary breeding flocks and from which a sample com prised 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 sub jected to one of the following proce dures: (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 con ducted in accordance with part 147 of this subchapter. (2) A participant handling U.S. M. Synoviae Clean products shall keep these products separate from other products in a manner satisfactory to the official State Agency. VerDate Sep<11>2014 13:56 Feb 14, 2018 Jkt 244028 PO 00000 Frm 00921 Fmt 8010 Sfmt 8010 Q:\09\9V1.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 912 9 CFR Ch. I (1–1–18 Edition) § 145.33 (3) U.S. M. Synoviae Clean chicks shall be boxed in clean boxes and deliv ered in trucks that have been cleaned and disinfected in accordance with part 147 of this subchapter. (4) Before male breeding birds may be added to a participating multiplier breeding flock, a sample of at least 30 birds to be added, with a minimum of 10 birds per pen, shall be tested for M. synoviae as provided in § 145.14(b) or by a polymerase chain reaction (PCR) based procedure in accordance with part 147 of this subchapter. 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 inhibi tion 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 accord ance with part 147 of this subchapter with respect to Mycoplasma isolation, sanitation, and management. (4) The flock’s freedom from M. gallisepticum is demonstrated by a neg ative 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 in accordance with part 147 of this subchapter. (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 accord ance with part 147 of this subchapter with respect to Mycoplasma isolation, sanitation, and management. (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 in accordance with part 147 of this subchapter. (h)–(i) [Reserved] (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: Pro vided, That to retain this classifica tion, 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 sam pled. 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 satis factory to the Official State Agency: Provided, That U.S. M. Gallisepticum Monitored chicks from multiplier breeding flocks shall be produced in in cubators and hatchers in which only eggs from flocks qualified under para graph (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 § 145.83(c)(1)(i) are set. (3) U.S. M. Gallisepticum Monitored chicks shall be boxed in clean boxes VerDate Sep<11>2014 13:56 Feb 14, 2018 Jkt 244028 PO 00000 Frm 00922 Fmt 8010 Sfmt 8010 Q:\09\9V1.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 913 Animal and Plant Health Inspection Service, USDA § 145.33 and delivered in trucks that have been cleaned and disinfected in accordance with part 147 of this subchapter. (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 pro vided 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 satisfac tory to the Official State Agency: Pro vided, That U.S. M. Synoviae Mon itored 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 § 145.83(d)(1)(i) 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 in accordance with part 147 of this subchapter. (l) U.S. Avian Influenza Clean. This program is intended to be the basis from which the breeding-hatchery in dustry may conduct a program for the prevention and control of avian influ enza. It is intended to determine the presence of avian influenza in multi plier breeding chickens through rou tine surveillance of each participating breeding flock. A flock and the hatch ing eggs and chicks produced from it will qualify for this classification when the Official State Agency determines that they have met the following re quirements: (1) It is a multiplier breeding flock in which a minimum of 30 birds have been tested negative for antibodies to avian influenza using an approved test as de scribed in § 145.14 when more than 4 months of age. To retain this classi fication: (i) A sample of at least 15 birds must be tested negative at intervals of 90 days; or (ii) A sample of fewer than 15 birds may be tested, and found to be nega tive, at any one time if all pens are equally represented and a total of 30 birds is tested within each 90-day pe riod; or (iii) The flock is tested as provided in § 145.14(d) at intervals of 30 days or less and found to be negative, and a total of 15 samples are collected and tested within each 90-day period; and (2) During each 90-day period, all multiplier spent fowl, up to a max imum of 30, must be tested serologi cally and found negative for antibodies for avian influenza within 21 days prior to movement to slaughter. (m) U.S. Salmonella Enteritidis Mon itored. This classification is intended for multiplier meat-type breeders wish ing to monitor their breeding flocks for Salmonella enteritidis. (1) A flock and the hatching eggs and chicks produced from it shall be eligi ble for this classification if they meet the following requirements, as deter mined by the Official State Agency: (i) The flock originated from a U.S. S. Enteritidis Clean primary meat-type breeding flock. (ii) The flock is maintained in ac cordance with part 147 of this sub chapter with respect to Salmonella iso lation, sanitation, and management. (iii) Environmental samples are col lected from the flock in accordance with part 147 of this subchapter at 16– 18 and 40–45 weeks of age. The samples shall be examined bacteriologically for group D Salmonella at an authorized laboratory, and cultures from group D positive samples shall be serotyped. (2) The following actions must be taken with respect to the test results that are generated from this S. enteritidis monitoring program: (i) If S. enteritidis is isolated from an environmental sample collected from the flock in accordance with paragraph VerDate Sep<11>2014 13:56 Feb 14, 2018 Jkt 244028 PO 00000 Frm 00923 Fmt 8010 Sfmt 8010 Q:\09\9V1.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 914 9 CFR Ch. I (1–1–18 Edition) § 145.34 (m)(1)(iii) of this section, a thorough evaluation of the practices and pro grams associated with the sampled flock shall be conducted with the goal of ascertaining the reason(s) for the positive finding. (ii) The test results and the results of any evaluations performed in accord ance with paragraph (m)(2)(i) of this section will be reported on a quarterly basis to the Official State Agency and the NPIP Senior Coordinator. (iii) Participating broiler integrators shall combine their respective test re sults (and the results of any associated evaluations) to help guide their deci sionmaking regarding programs and practices to implement or maintain to address S. enteritidis. (iv) Aggregate data regarding the prevalence of S. enteritidis in partici pating U.S. meat-type parent breeding flocks shall be made available to the U.S. Poultry and Egg Association and the National Chicken Council. (3) This classification may be re voked by the Official State Agency if the participant fails to comply with the requirements of this classification. The Official State Agency shall not re voke the participant’s classification until the participant has been given an opportunity for a hearing in accord ance with rules of practice adopted by the Official State Agency. (Approved by the Office of Management and Budget under control number 0579–0007) [36 FR 23112, Dec. 3, 1971] EDITORIAL NOTE: For FEDERAL REGISTER ci tations affecting § 145.33, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.fdsys.gov. § 145.34 Terminology and classifica tion; States. (a) U.S. Pullorum-Typhoid-Clean State. (1) A State will be declared a U.S. Pul lorum-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), § 145.53(b)(3)(i) through (vii), § 145.73(b)(2)(i), § 145.83(b)(2)(i), and § 145.93(b)(3)(i) through (vii). (ii) No pullorum disease or fowl ty phoid is known to exist nor to have ex isted in hatchery supply flocks within the State during the preceding 12 months: Provided, That pullorum dis ease or fowl typhoid found within the preceding 24 months in waterfowl, exhi bition poultry, and game bird breeding flocks will not prevent a State, which is otherwise eligible from qualifying. (2) Discontinuation of any of the con ditions described in paragraph (a)(1)(i) of this section, or repeated outbreaks of pullorum or typhoid occur in hatch ery supply flocks described in para graph (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 classi fication. 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 accord ance 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 in accord ance with §§ 145.33(c) and 145.83(c) 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 equiv alent 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 VerDate Sep<11>2014 13:56 Feb 14, 2018 Jkt 244028 PO 00000 Frm 00924 Fmt 8010 Sfmt 8010 Q:\09\9V1.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 915 Animal and Plant Health Inspection Service, USDA § 145.43 State are required to report to the Offi cial 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 in fection in chickens from meat-type chicken breeding flocks are promptly followed by an investigation by the Of ficial State Agency to determine the origin of the infection; (vii) All chickens from meat-type chicken breeding flocks found to be in fected with M. gallisepticum are quar antined until marketed under super vision of the Official State Agency. (2) Discontinuation of any of the con ditions 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 origi nating premises, the Service shall have grounds to revoke its determination that the State is entitled to this classi fication. 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 accord ance 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; 72 FR 1419, Jan. 12, 2007; 76 FR 15793, Mar. 22, 2011] Subpart D—Special Provisions for Turkey Breeding Flocks and Products § 145.41 Definitions. Except where the context otherwise requires, for the purposes of this sub part the following terms shall be con strued, 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] § 145.42 Participation. (a) Participating turkey flocks, and the eggs and poults produced from them, shall comply with the applicable general provisions of subpart A of this part and the special provisions of this subpart D. (b) Hatching eggs should be nest clean. They may be fumigated in ac cordance with part 147 of this sub chapter or otherwise sanitized. (c) Any nutritive material provided to poults must be free of the avian pathogens that are officially rep resented in the Plan disease classifica tions listed in § 145.10. [36 FR 23112, Dec. 3, 1971, as amended at 38 FR 13707, May 24, 1973; 40 FR 1503, Jan. 8, 1975. Redesignated at 44 FR 61586, Oct. 26, 1979, and amended at 49 FR 19802, May 10, 1984; 57 FR 57341, Dec. 4, 1992; 65 FR 8018, Feb. 17, 2000; 68 FR 64511, Nov. 14, 2003; 79 FR 38757, July 9, 2014; 81 FR 53249, Aug. 12, 2016] § 145.43 Terminology and classifica tion; flocks and products. Participating flocks, and the eggs and poults produced from them, which have met the respective requirements specified in this section may be des ignated 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 cri teria in one of the following paragraphs (b)(1) through (5) of this section: Pro vided, That a flock qualifying by means of a blood test shall be tested within the past 12 months, except that the re testing 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 prog eny of a primary breeding flock which is intended solely for the production of multiplier breeding flocks, and meets the following specifications as deter mined 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 VerDate Sep<11>2014 13:56 Feb 14, 2018 Jkt 244028 PO 00000 Frm 00925 Fmt 8010 Sfmt 8010 Q:\09\9V1.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 916 9 CFR Ch. I (1–1–18 Edition) § 145.43 State are required to report to the Offi cial 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. Pul lorum-Typhoid Clean breeding flocks or from flocks that met equivalent re quirements under official supervision; and (iii) The flock is located on a prem ises where a flock not classified as U.S. Pullorum-Typhoid Clean was located the previous year; Provided, That an Authorized Testing Agent must blood test up to 300 birds per flock, as de scribed 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 per formed 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 qualifica tion 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 prog eny of a primary breeding flock which is intended solely for the production of multiplier breeding flocks, that origi nated from U.S. Pullorum-Typhoid Clean breeding flocks or from flocks that met equivalent requirements under official supervision, and is lo cated 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 re quirements for pullorum-typhoid con trol 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 super vision: Provided, That if other domes ticated 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 prohib ited; (iv) All persons performing poultry disease diagnostic services within the State are required to report to the Offi cial 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 out break 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 Im provement Plan will conduct an inves tigation; (vi) All flocks found to be infected with pullorum or typhoid are quar antined 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 dem onstrate 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 occur rence of repeated outbreaks of pul lorum 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 in vestigation has been made by the Serv ice 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 de termined by the Service to be in com pliance with the provisions of para graph (b)(3) of this section and in which pullorum disease or fowl typhoid is not VerDate Sep<11>2014 13:56 Feb 14, 2018 Jkt 244028 PO 00000 Frm 00926 Fmt 8010 Sfmt 8010 Q:\09\9V1.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 917 Animal and Plant Health Inspection Service, USDA § 145.43 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 lo cated in a State determined to be in compliance with the provisions of para graph (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 re actors: Provided, That a bacteriological examination monitoring program ac ceptable 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 part 147 of this subchapter with respect to Mycoplasma isolation, sanitation, and management, and in which no re actors 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): Pro vided, That to retain this classifica tion, 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 there after. (2) A flock qualified as U.S. M. Gallisepticum Clean may retain the classification through its first egg-lay ing cycle, provided it is maintained in isolation and no evidence of M. gallisepticum infection is revealed. A flock which is molted following com pletion of an egg-laying cycle and sub sequently brought back into produc tion, shall be retested within 2 weeks prior to production, as described in paragraph (c)(1) of this section. A State inspector shall visit with the owner or manager of each flock at least once during each laying cycle to discuss and ascertain whether the flock is being maintained in accordance with part 147 of this subchapter with respect to Mycoplasma isolation, sanitation, and management. If a flock proves to be in fected with M. gallisepticum, it shall lose this classification. (3) In order to sell hatching eggs or poults of this classification, all hatch ing eggs and poults handled by the par ticipant 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: Pro vided, That to retain this classifica tion, 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 there after. (2)–(3) [Reserved] (4) When reactors to the official test are found and can be identified, 10 tra cheal swabs and/or vaginal or phallus swabs and their corresponding blood samples shall be submitted to a labora tory for serological and cultural exam ination. If reactors cannot be identi fied, at least 30 tracheal swabs and/or vaginal or phallus swabs and their cor responding blood samples shall be sub mitted. 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 examina tion. (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 re tested at 28–30 weeks of age and at 4–6 week intervals thereafter. It is rec ommended that any birds that are showing clinical signs of M. synoviae infection be included in samples taken. (2) When reactors to the official test are found and can be identified, tra cheal swabs and their corresponding blood samples from 10 (all if fewer than 10) reacting birds shall be submitted to an authorized laboratory for sero logical and cultural examination. If re actors cannot be identified, at least 30 VerDate Sep<11>2014 13:56 Feb 14, 2018 Jkt 244028 PO 00000 Frm 00927 Fmt 8010 Sfmt 8010 Q:\09\9V1.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 918 9 CFR Ch. I (1–1–18 Edition) § 145.43 5 Preparation and use of this type of vac cine may be regulated by state statutes. 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 sub mitted to the laboratory within 10 days for serology, necropsy, and thorough bacteriological examination. When re actors to the official test are found, the procedures outlined in part 147 of this subchapter will be used to determine the status of the flock. (f) U.S. Sanitation Monitored, Turkeys. A flock or hatchery whose owner is controlling or reducing the level of sal monella through compliance with sani tation and management practices in accordance with part 147 of this sub chapter, and where the following moni toring, testing, and management prac tices are conducted: (1) Hatchery debris (dead germ hatch ing eggs, fluff, and meconium collected by sexors), swabs collected from hatch debris in hatcher trays, a sample of all the poults that died within 10 days after hatching up to 10 poults, or a combination of 2 or all 3 of the above, from each hatch or a candidate breed ing flock produced by a primary breed er, are examined bacteriologically at an authorized laboratory for Sal monella. (2) The poults for the candidate breeding flock are placed in a building that has been cleaned and disinfected. An Authorized Agent must collect en vironmental samples from the building and submit them to an authorized lab oratory for a bacteriological examina tion for the presence of Salmonella, in accordance with part 147 of this sub chapter. (3) Feed for turkeys in the candidate and breeding flock should meet the fol lowing 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 tem perature of 185 °F for a minimum of 6 minutes of retention in the condi tioning chamber. The conditioned mash feed moisture must be a min imum of 16 percent during the condi tioning 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 condi tioned 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 treat ment; 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 trans ported in such a manner as to prevent possible contamination with patho genic bacteria. (iv) FDA-approved products for Sal monella control may be added to either unfinished or finished feed. (4) Environmental samples shall be taken by an Authorized Agent, in ac cordance with part 147 of this sub chapter, from each flock at 12–20 weeks of age and examined bacteriologically at an authorized laboratory for Sal monella. (5) Owners of flocks found infected with a paratyphoid Salmonella may vaccinate these flocks with an autog enous bacterin with a potentiating agent. 5 (6) Environmental samples shall be taken by an Authorized Agent, in ac cordance with part 147 of this sub 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 Sal monella. (7) Hatchery debris (dead germ hatch ing eggs, fluff, and meconium collected by sexors), swabs collected from hatch debris in hatcher trays, a sample of all the poults that died within 10 days after hatching up to 10 poults, or a combination of 2 or all 3 of the above, VerDate Sep<11>2014 13:56 Feb 14, 2018 Jkt 244028 PO 00000 Frm 00928 Fmt 8010 Sfmt 8010 Q:\09\9V1.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 919 Animal and Plant Health Inspection Service, USDA § 145.44 shall be cultured as a means of evalu ating the effectiveness of the control procedures. (g) U.S. H5/H7 Avian Influenza Clean. This program is intended to be the basis from which the turkey breeding industry may conduct a program for the prevention and control of the H5/H7 subtypes of avian influenza. It is in tended to determine the presence of the H5/H7 subtypes of avian influenza in breeding turkeys through routine sur veillance of each participating breed ing 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 require ments: (1) It is a primary breeding flock in which a minimum of 30 birds have been tested negative to the H5/H7 subtypes of avian influenza as provided in § 145.14(d) when more than 4 months of age and prior to the onset of egg pro duction. 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 nega tive, at any one time if all pens are equally represented and a total of 30 birds are tested within each 90-day pe riod. (2) It is a multiplier breeding flock in which a minimum of 30 birds have been tested negative for antibodies for avian influenza to the H5/H7 subtypes of avian influenza as provided in § 145.14(d) when more than 4 months of age and prior to the onset of egg production. To retain this classification: (i) A sample of at least 30 birds must be tested negative at intervals of 90 days; or (ii) A sample of fewer than 30 birds may be tested, and found to be nega tive, at any one time if all pens are equally represented and a total of 30 birds are tested within each 90-day pe riod. (3) All spent fowl being marketed for meat from flocks that have been tested as required by this paragraph shall be tested at a rate of 6 birds per flock within 21 days prior to movement to slaughter. (4) For both primary and multiplier breeding flocks, if a killed influenza vaccine against avian influenza subtypes other than H5 and H7 is used, then the hemagglutinin and the neuraminidase subtypes of the vaccine must be reported to the Official State Agency for laboratory and reporting purposes. (Approved by the Office of Management and Budget under control number 0579–0007) [36 FR 23112, Dec. 3, 1971] EDITORIAL NOTE: For FEDERAL REGISTER ci tations affecting § 145.43, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.fdsys.gov. § 145.44 Terminology and classifica tion; States. (a) U.S. Pullorum-Typhoid Clean State. (1) A State will be declared a U.S. Pul lorum-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), § 145.53(b)(3)(i) through (vii), § 145.73(b)(2)(i), § 145.83(b)(2)(i), and § 145.93(b)(3)(i) through (vii). (ii) No pullorum disease or fowl ty phoid is known to exist nor to have ex isted in hatchery supply flocks within the State during the preceding 12 months: Provided, That pullorum dis ease or fowl typhoid found within the preceding 24 months in waterfowl, exhi bition poultry, and game bird breeding flocks will not prevent a State, which is otherwise eligible, from qualifying. (2) Discontinuation of any of the con ditions described in paragraph (a)(1)(i) of this section, or repeated outbreaks of pullorum or typhoid occur in hatch ery supply flocks described in para graph (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 classi fication. 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 accord ance with rules of practice adopted by the Administrator. VerDate Sep<11>2014 13:56 Feb 14, 2018 Jkt 244028 PO 00000 Frm 00929 Fmt 8010 Sfmt 8010 Q:\09\9V1.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 920 9 CFR Ch. I (1–1–18 Edition) § 145.44 (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 ty phoid is known to exist nor to have ex isted in turkey hatchery supply flocks within the State during the preceding 24 months. (2) Discontinuation of any of the con ditions described in paragraph (b)(1)(i) of this section, or repeated outbreaks of pullorum or typhoid occur in hatch ery supply flocks described in para graph (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 Adminis trator. (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 pro duction are classified as U.S. M. Gallisepticum Clean or have met equiv alent requirements for M. gallisepticum control under official supervision. (iii) All turkey hatcheries within the State handle products which are classi fied 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 Offi cial 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 in fection in turkeys are promptly fol lowed by an investigation by the Offi cial State Agency to determine the ori gin of the infection. (vii) All turkey flocks found to be in fected with M. gallisepticum are quar antined until marketed under super vision of the Official State Agency. (2) Discontinuation of any of the con ditions described in paragraph (c)(1) of this section, or if repeated outbreaks of M. gallisepticum occur in turkey breed ing flocks described in paragraph (c)(1)(ii) of this section, or if an infec tion spreads from the originating premises, the Service shall have grounds to revoke its determination that the State is entitled to this classi fication. 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 accord ance 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, Tur keys. (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 pro duction are tested and classified as U.S. M. Synoviae Clean or have met equivalent requirements for M. synoviae control under official super vision; (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 su pervision; (iv) All shipments of products from turkey breeding flocks other than those classified as U.S. M. Synoviae VerDate Sep<11>2014 13:56 Feb 14, 2018 Jkt 244028 PO 00000 Frm 00930 Fmt 8010 Sfmt 8010 Q:\09\9V1.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 921 Animal and Plant Health Inspection Service, USDA § 145.45 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 Offi cial 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 infec tion 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 su pervision 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 para graph (d)(1) of this section are discon tinued. 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 accord ance 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, Tur keys, 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 pro duction are tested and classified as U.S. M. Meleagridis Clean or have met equivalent requirements for M. meleagridis control under official super vision; (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 Offi cial 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 in fection in turkeys are promptly fol lowed by an investigation by the Offi cial State Agency to determine the ori gin of the infection; and (vii) All turkey breeding flocks found to be infected with M. meleagridis are quarantined until marketed under su pervision 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 para graph (d)(1) of this section are discon tinued. The Service will not revoke the State’s classification as a U.S. M. Meleagridis Clean State, Turkeys, until it has conducted an investigation and the Official State Agency has been given an opportunity for a hearing in accordance with rules of practice adopted by the Administrator. (Approved by the Office of Management and Budget under control number 0579–0007) [40 FR 1503, Jan. 8, 1975. Redesignated at 44 FR 61586, Oct. 26, 1979, and amended at 45 FR 10316, Feb. 15, 1980; 48 FR 57473, Dec. 30, 1983; 49 FR 19803, May 10, 1984; 54 FR 23957, June 5, 1989; 61 FR 11521, Mar. 21, 1996; 65 FR 8018, Feb. 17, 2000; 67 FR 8469, Feb. 25, 2002; 76 FR 15793, Mar. 22, 2011] § 145.45 Terminology and classifica tion; compartments. (a) U.S. H5/H7 Avian Influenza Clean Compartment. This program is intended to be the basis from which the primary turkey breeding-hatchery industry may demonstrate the existence and im plementation of a program that has been approved by the Official State Agency and the Service to establish a compartment consisting of a primary breeding-hatchery company that is free of H5/H7 avian influenza (AI), also re ferred to as notifiable avian influenza (NAI). This compartment has the pur pose of protecting the defined sub population and avoiding the introduc tion and spread of NAI within that sub population by prohibiting contact with other commercial poultry operations, other domestic and wild birds, and VerDate Sep<11>2014 13:56 Feb 14, 2018 Jkt 244028 PO 00000 Frm 00931 Fmt 8010 Sfmt 8010 Q:\09\9V1.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 922 9 CFR Ch. I (1–1–18 Edition) § 145.45 other intensive animal operations. The program shall consist of the following: (1) Definition of the compartment. Based on the guidelines established by the World Organization for Animal Health (OIE) in the Terrestrial Animal Health Code and the guidelines in this paragraph (a), the primary breeder company will define the compartment with respect to NAI. Specifically, the company will use a comprehensive bio security program to define the com partment as a subpopulation of poultry with a health status for NAI that is separate from birds and poultry outside the compartment. The Official State Agency and the Service must approve all documentation submitted to sub stantiate the defined compartment as adequate to qualify for epidemiological separation from other potential sources of infection of NAI. Guidelines for the definition of the compartment include: (i) Definition and description of the subpopulation of birds and their health status. All birds included in the com partment must be U.S. H5/H7 Avian In fluenza Clean in accordance with § 145.43(g). The poultry must also be lo cated in a State that has an initial State response and containment plan approved by APHIS under § 56.10 of this chapter and that participates in the di agnostic surveillance program for H5/ H7 low pathogenicity AI as described in § 145.15. Within the compartment, all official tests for AI, as described in § 145.14(d), must be conducted in State or Federal laboratories or in NPIP au thorized laboratories that meet the minimum standards described in § 147.52 of this subchapter. In addition, the company must provide to the Serv ice upon request any relevant histor ical and current NAI-related data for reference regarding surveillance for the disease within the compartment. Upon request, the Official State Agency may provide such data for other commercial poultry populations located in the State. (ii) Description of animal identification and traceability processes. The primary breeder company must also include a description of its animal identification and traceability records, including ex amples of Veterinary Services (VS) Form 9–5, ‘‘Report of Hatcheries, Deal ers and Independent Flocks’’; VS Form 9–2, ‘‘Flock Selection and Testing Re port’’; VS Form 9–3, ‘‘Report of Sales of Hatching Eggs, Chicks and Poults’’; VS Form 9–9, ’’ Hatchery Inspection Re port’’; set and hatch records; egg re ceipts; and egg/chick invoices for the subpopulation. Documentation must also include breed identification (NPIP stock code). The Service should ensure that an effective flock identification system and traceability system are in place. (iii) Definition and description of the physical components or establishments of the defined compartment. The primary breeder company must provide docu mentation establishing that the de fined compartment is epidemiologically separated from other poultry and bird populations. The doc umentation must be approved by the Official State Agency and the Service as indicating adequate epidemiological separation to maintain the compart ment’s separate health status with re spect to NAI. The documentation should include descriptions of: (A) The physical and spatial factors that separate the compartment from surrounding bird populations and affect the biosecurity status of the compart ment. (B) Relevant environmental factors that may affect exposure of the birds to AI. (C) The functional boundary and fencing that are used to control access to the compartment. (D) Facilities and procedures to pre vent access by wild birds and to pro vide separation from other relevant hosts. (E) The relevant infrastructural fac tors that may affect exposure to AI, in cluding the construction and design of buildings or physical components, cleaning and disinfection of buildings and physical components between pro duction groups with quality assurance verification, cleaning and disinfection of equipment, and introduction of equipment or material into the com partment. VerDate Sep<11>2014 13:56 Feb 14, 2018 Jkt 244028 PO 00000 Frm 00932 Fmt 8010 Sfmt 8010 Q:\09\9V1.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 923 Animal and Plant Health Inspection Service, USDA § 145.45 (iv) Definition and description of the functional relationships between compo nents of the defined compartment. Func tional relationships between compo nents of the compartment include traf fic movement and flow at and among premises, personnel movement at and among premises, exposure to live bird populations, and any other factors that could affect biosecurity of the com partment. All physical components of the compartment must be maintained in compliance with hygiene and bio security procedures for poultry pri mary breeding flocks and hatcheries in accordance with part 147 of this sub chapter. In addition, the company must provide a biosecurity plan for the compartment and all included compo nents. The biosecurity plan should in clude: (A) Requirements that company em ployees and contract growers limit their contact with live birds outside the compartment. (B) An education and training pro gram for company employees and con tractors. (C) Standard operating procedures for company employees, contractors, and outside maintenance personnel. (D) Requirements for company em ployees and non-company personnel who visit any premises within the com partment. (E) Company veterinary infrastruc ture to ensure flock monitoring and disease diagnosis and control measures. (F) Policies for management of vehi cles and equipment used within the compartment to connect the various premises. (G) Farm site requirements (location, layout, and construction). (H) Pest management program. (I) Cleaning and disinfection process. (J) Requirements for litter and dead bird removal and/or disposal. (v) Description of other factors impor tant for maintaining the compartment. The company veterinary infrastructure will assess sanitary measures, environ mental risk factors, and management and husbandry practices that relate to the separation of the compartment and the health status of the birds contained within the compartment that may af fect risk of exposure to NAI. This as sessment must include a description of internal monitoring and auditing sys tems (e.g., quality assurance and qual ity control programs) to demonstrate the effectiveness of the compartment. Upon request, the Service will provide the company with information on the epidemiology of NAI and the associated risk pathways in which the compo nents of the compartment are located. (vi) Approval or denial. Based on this documentation provided under this paragraph (a)(1), as well as any other information the Service and the Offi cial State Agency determine to be nec essary, the Service and the Official State Agency will approve or deny the classification of the compartment as U.S. H5/H7 Avian Influenza Clean. (2) Company activities for maintenance of the compartment. (i) The primary breeder company’s management of bio security, surveillance, and disease con trol efforts must be uniform and equiv alent among all components that are a part of the compartment. Oversight and inspection of these management practices must be conducted by the company’s licensed, accredited veteri narians. (ii) Veterinary staff from the Official State Agency and NPIP staff will work in partnership with licensed, accred ited veterinarians to train and certify auditors through Service-approved workshops. The trained auditors will conduct biosecurity and operational audits at least once every 2 years to ensure the integrity of the compart ment. These audits will include evalua tion of the critical control points and standard operating practices within the compartment, verification of the health status of the flock(s) contained within the compartment, and examina tion of the biosecurity and manage ment system of the integrated compo nents of the compartment. (iii) In addition, the company must demonstrate compliance with para graph (a)(1) of this section for remain ing in the U.S. H5/H7 Avian Influenza Clean classification, surveillance for NAI within the compartment, and con ducting tests in State or Federal lab oratories or in NPIP authorized labora tories. Accredited veterinarians are re sponsible for the enforcement of active and passive surveillance of NAI in pri mary breeder flocks. Baseline health VerDate Sep<11>2014 13:56 Feb 14, 2018 Jkt 244028 PO 00000 Frm 00933 Fmt 8010 Sfmt 8010 Q:\09\9V1.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 924 9 CFR Ch. I (1–1–18 Edition) § 145.51 status must be maintained for all flocks or subpopulations within the compartment, indicating the dates and negative results of all avian influenza surveillance and monitoring testing, the dates and history of last disease oc currence (if any), the number of out breaks, and the methods of disease con trol that were applied. (iv) Documentation will be main tained in the company’s database and will be verified as required by the Serv ice and/or the Official State Agency. (3) Service and Official State Agency activities for maintenance of the compart ment. The Service will work in coopera tion with the Official State Agencies to ensure the continued integrity of any recognized compartments. Activities will include: (i) Oversight of the establishment and management of compartments; (ii) Establishment of effective part nerships between the Service, the Plan, and the primary breeder industry; (iii) Approval or denial of classifica tion of compartments as U.S. H5/H7 Avian Influenza Clean Compartments under paragraph (a)(1) of this section; (iv) Official certification of the health status of the compartment, and commodities that may be traded from it through participation in the Plan for avian diseases, including the U.S. H5/ H7 Avian Influenza Clean program as described in § 145.43(g) and diagnostic surveillance for H5/H7 low pathoge nicity AI as described in § 145.15; (v) Conducting audits of compart ments at least once every 2 years to: (A) Confirm that the primary breed ing company’s establishments are epidemiologically distinct and path ways for the introduction of disease into the compartment are closed through routine operational proce dures; and (B) Evaluate and assess the manage ment and husbandry practices relating to biosecurity to determine whether they are in compliance with hygiene and biosecurity procedures for poultry primary breeding flocks and hatcheries in accordance with part 147 of this sub chapter; (vi) Providing, upon request, model plans for management and husbandry practices relating to biosecurity in ac cordance with part 147 of this sub chapter, risk evaluations in conjunc tion with the primary breeder industry (including disease surveillance such as VS Form 9–4, ‘‘Summary of Breeding Flock Participation’’), and diagnostic capability summaries and systems for initial State response and containment plans in accordance with § 56.10 of this chapter; and (vii) Publicizing and sharing com partment information with inter national trading partners, upon re quest, to establish approval and rec ognition of the compartment, including timeliness and accuracy of disease re porting and surveillance measures as described in §§ 145.15 and 145.43(g). (4) Emergency response and notifica tion. In the case of a confirmed positive of NAI in the subpopulation of the compartment, the management of the compartment must notify the Service. The Service will immediately suspend the status of the compartment. A com partment will be eligible to resume trade with importing countries only after the compartment has adopted the necessary measures to reestablish the biosecurity level and confirm that NAI is not present in the compartment and the Service has reevaluated the man agement and biosecurity measures of the compartment and approved said compartment for trade. (b) [Reserved] [79 FR 38757, July 9, 2014] Subpart E—Special Provisions for Hobbyist and Exhibition Wa terfowl, Exhibition Poultry, and Game Bird Breeding Flocks and Products § 145.51 Definitions. Except where the context otherwise requires, for the purposes of this sub part the following terms shall be con strued, respectively, to mean: Exhibition Poultry. Domesticated fowl which are bred for the combined pur poses 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. VerDate Sep<11>2014 13:56 Feb 14, 2018 Jkt 244028 PO 00000 Frm 00934 Fmt 8010 Sfmt 8010 Q:\09\9V1.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 925 Animal and Plant Health Inspection Service, USDA § 145.53 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] § 145.52 Participation. Participating flocks of hobbyist and exhibition waterfowl, exhibition poul try, 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. The special provisions that apply to meat-type waterfowl flocks are found in subpart I of this part. (a) Started poultry shall lose their identity under Plan terminology when not maintained by Plan participants under the conditions prescribed in § 145.5(a). (b) Hatching eggs produced by pri mary breeding flocks shall be fumi gated or otherwise sanitized in accord ance with part 147 of this subchapter. (c) It is recommended that waterfowl flocks and gallinaceous flocks in open air facilities be kept separate. (d) Subject to the approval of the Service and the Official State Agencies in the importing and exporting States, participating flocks may report poul try sales to importing States by using either VS Form 9–3, ‘‘Report of Sales of Hatching Eggs, Chicks, and Poults,’’ or by using a hatchery invoice form (9–3I) approved by the Official State Agency and the Service to identify poultry sales to clients. If the selling hatchery uses the 9–3I form, the following infor mation must be included on the form: (1) The form number ‘‘9–3I’’, printed or stamped on the invoice; (2) The hatchery name and address; (3) The date of shipment; (4) The hatchery invoice number; (5) The purchaser name and address; (6) The quantity of products sold; (7) Identification of the products by bird variety or by NPIP stock code as listed in the NPIP APHIS 91–55–078 ap pendix; and (8) The appropriate NPIP illustrative design in § 145.10. One of the designs in § 145.10(b) or (g) must be used. The fol lowing information must be provided in or near the NPIP design: (i) The NPIP State number and NPIP hatchery approval number; and (ii) The NPIP classification for which product is qualified (e.g., U.S. Pul lorum-Typhoid Clean). (e) Any nutritive material provided to baby poultry must be free of the avian pathogens that are officially rep resented in the Plan disease classifica tions 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; 74 FR 14715, Apr. 1, 2009; 76 FR 15793, Mar. 22, 2011; 79 FR 38759, July 9, 2014] § 145.53 Terminology and classifica tion; flocks and products. Participating flocks, and the eggs and baby poultry produced from them, which have met the respective require ments 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 para graphs (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 reac tors. (2) It is a multiplier breeding flock, or a breeding flock composed of prog eny of a primary breeding flock which is intended solely for the production of multiplier breeding flocks, and meets the following specifications as deter mined 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 Offi cial 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. Pul lorum-Typhoid Clean breeding flocks VerDate Sep<11>2014 13:56 Feb 14, 2018 Jkt 244028 PO 00000 Frm 00935 Fmt 8010 Sfmt 8010 Q:\09\9V1.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 926 9 CFR Ch. I (1–1–18 Edition) § 145.53 or from flocks that met equivalent re quirements under official supervision; and (iii) The flock is located on a prem ises where a flock not classified as U.S. Pullorum-Typhoid Clean was located the previous year; Provided, That an Authorized Testing Agent must blood test up to 300 birds per flock, as de scribed 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 per formed 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 qualifica tion 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 require ments 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 Hatch eries’’ or have met equivalent require ments for pullorum-typhoid control under official supervision; (ii) All hatchery supply flocks within the State, are qualified as U.S. Pul lorum-Typhoid Clean or have met equivalent requirements for pullorum typhoid control under official super vision: Provided, That if other domes ticated 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 prohib ited; (iv) All persons performing poultry disease diagnostic services within the State are required to report to the Offi cial 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 out break 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 Im provement Plan will conduct an inves tigation; (vi) All flocks found to be infected with pullorum or typhoid are quar antined 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 dem onstrate pullorum or typhoid infection; (vii) All poultry, including exhi bition, exotic, and game birds, but ex cluding waterfowl, going to public ex hibition shall come from U.S. Pul lorum-Typhoid Clean or equivalent flocks, or have had a negative pul lorum-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 oc currence of repeated outbreaks of pul lorum 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 in vestigation has been made by the Serv ice 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 de termined by the Service to be in com pliance with the provisions of para graph (b)(3) of this section, and in which pullorum disease or fowl typhoid is not known to exist nor to have ex isted in hatchery supply flocks within the State during the preceding 24 months. VerDate Sep<11>2014 13:56 Feb 14, 2018 Jkt 244028 PO 00000 Frm 00936 Fmt 8010 Sfmt 8010 Q:\09\9V1.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 927 Animal and Plant Health Inspection Service, USDA § 145.53 (5) It is a primary breeding flock lo cated in a State determined to be in compliance with the provisions of para graph (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: Pro vided, That a bacteriological examina tion 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 hobbyist or ex hibition waterfowl or exhibition poul try 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 ty phoid has been made that can be traced to a source in that State, a bacterio logical examination monitoring pro gram or a serological examination monitoring program acceptable to the Official State Agency and approved by the Service may be used in lieu of an nual blood testing. (c) U.S. M. Gallisepticum Clean. (1) A flock maintained in accordance with part 147 of this subchapter with respect to Mycoplasma isolation, sanitation, and management and in which freedom from M. gallisepticum has been dem onstrated under the criteria specified in paragraph (c)(1)(i) or (ii) of this sec tion. (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 matu rity: Provided, That to retain this clas sification, a random sample of serum or egg yolk or a targeted bird sample of the choanal palatine cleft/fissure area using appropriate swabs from all the birds in the flock if the flock size is less than 30, but at least 30 birds, shall be tested at intervals of not more than 90 days: And provided further, That a sample comprised of less than 30 birds may be tested at any one time, with the approval of the Official State Agen cy and the concurrence of the Service, provided that a total of at least 30 birds, or all birds in the flock if flock size is less than 30, 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 or all birds in the flock if the flock size is less than 30 birds, has been tested for M. gallisepticum as provided in § 145.14(b) when more than 4 months of age or upon reaching sexual matu rity: Provided, That to retain this clas sification, 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 or a targeted bird sample of the choanal palatine cleft/fissure area using appropriate swabs from all the birds in the flock if flock size is less than 30, but at least 30 birds, shall be tested; or (B) At intervals of not more than 30 days, a sample of 25 cull baby poultry produced from the flock shall be sub jected to laboratory procedures accept able to the Official State Agency and approved by the Service, for the detec tion 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 satisfac tory to the Official State Agency: Pro vided, That U.S. M. Gallisepticum Clean baby poultry from primary breeding flocks shall be produced in in cubators and hatchers in which only eggs from flocks qualified under para graph (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 in accordance with part 147 of this subchapter. (d) U.S. M. Synoviae Clean. (1) A flock maintained in accordance with part 147 of this subchapter with respect to Mycoplasma isolation, sanitation, and management and in which freedom from Mycoplasma synoviae has been demonstrated under the criteria speci fied in paragraph (d)(1)(i) or (d)(1)(ii) of this section. VerDate Sep<11>2014 13:56 Feb 14, 2018 Jkt 244028 PO 00000 Frm 00937 Fmt 8010 Sfmt 8010 Q:\09\9V1.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 928 9 CFR Ch. I (1–1–18 Edition) § 145.53 (i) It is a flock in which all birds or a sample of at least 300 birds has been tested for M. synoviae as provided in § 145.14(b) when more than 4 months of age or upon reaching sexual maturity: Provided, That to retain this classifica tion, a random sample of serum or egg yolk or a targeted bird sample of the choanal palatine cleft/fissure area using appropriate swabs (C.P. swabs) from all the birds in the flock if flock size is less than 30, 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 30 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 total of at least 30 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 random sam ple comprised of 50 percent of the birds in the flock, with a maximum of 200 birds and a minimum of 30 birds per flock or all birds in the flock if the flock is less than 30 birds, has been tested for M. synoviae as provided in § 145.14(b) when more than 4 months of age or upon reaching sexual maturity: Provided, That to retain this classifica tion, 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 or a targeted bird sample of the choanal palantine cleft/fissure area using appropriate swabs from all the birds in the flock if the flock size is less than 30, but at least 30 birds shall be tested: Provided, That a sample of fewer than 30 birds may be tested at any one time with the approval of the Official State Agency and the concur rence of the Service, provided that a total of at least 30 birds, or the entire flock if flock size is less than 30, is tested each time and a total of at least 30 birds is tested within each 90-day pe riod; or (B) At intervals of not more than 30 days, egg yolk testing shall be con ducted in accordance with part 147 of this subchapter. (2) A participant handling U.S. M. Synoviae Clean products shall keep those products separate from other products in a manner satisfactory to the Official State Agency: Provided, 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 deliv ered in trucks that have been cleaned and disinfected as described in in ac cordance with part 147 of this sub chapter. (e) U.S. H5/H7 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 the H5 and H7 subtypes of avian influenza. It is intended to determine the presence of the H5 and H7 subtypes of avian in fluenza in hobbyist or exhibition wa terfowl, exhibition poultry, and game bird breeding flocks through routine surveillance of each participating breeding flock. A flock, and the hatch ing 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 re quirements: (1) It is a primary breeding flock in which a minimum of 30 birds has been tested negative to the H5 and H7 subtypes of avian influenza as provided in § 145.14(d) when more than 4 months of age; Provided, that waterfowl flocks may test a minimum of 30 cloacal swabs for virus isolation. 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 nega tive, at any one time if all pens are equally represented and a total of 30 birds are tested within each 180-day pe riod. (2) It is a multiplier breeding flock in which a minimum of 30 birds has been tested negative to the H5 and H7 subtypes of avian influenza as provided in § 145.14(d) when more than 4 months of age; Provided, that waterfowl flocks may test a minimum of 30 cloacal VerDate Sep<11>2014 13:56 Feb 14, 2018 Jkt 244028 PO 00000 Frm 00938 Fmt 8010 Sfmt 8010 Q:\09\9V1.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 929 Animal and Plant Health Inspection Service, USDA § 145.61 swabs for virus isolation. 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 nega tive, at any one time if all pens are equally represented and a total of 30 birds are tested within each 180-day pe riod. (3) A sample of at least 30 birds must be tested and found negative to H5/H7 avian influenza within 21 days prior to movement to slaughter. (f) U.S. Salmonella Monitored. This program is intended to be the basis from which the hatching industry may conduct a program for the prevention and control of salmonellosis. It is in tended to reduce the incidence of Sal monella organisms in day-old poultry through an effective and practical sani tation program in the hatchery. This will afford other segments of the poul try industry an opportunity to reduce the incidence of Salmonella in their products. The following requirements must be met for a flock to be of this classification: (1) An Authorized Agent shall collect a minimum of five environmental sam ples, e.g., chick papers, hatching trays, and chick transfer devices, from the hatchery at least every 30 days. Test ing must be performed at an authorized laboratory. (2) To claim products are of this clas sification, all products shall be derived from a hatchery that meets the re quirements of the classification. (3) This classification may be re voked by the Official State Agency if the participant fails to follow rec ommended corrective measures. (Approved by the Office of Management and Budget under control number 0579–0007) [36 FR 23112, Dec. 3, 1971. Redesignated at 44 FR 61586, Oct. 26, 1979] EDITORIAL NOTE: For FEDERAL REGISTER ci tations affecting § 145.53, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.fdsys.gov. § 145.54 Terminology and classifica tion; States. (a) U.S. Pullorum-Typhoid Clean State. (1) A State will be declared a U.S. Pul lorum-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), § 145.53(b)(3)(i) through (vii), § 145.73(b)(2)(i), § 145.83(b)(2)(i), and § 145.93(b)(3)(i) through (vii). (ii) No pullorum disease or fowl ty phoid is known to exist nor to have ex isted in hatchery supply flocks within the State during the preceding 12 months: Provided, That pullorum dis ease or fowl typhoid found within the preceding 24 months in waterfowl, exhi bition poultry, and game bird breeding flocks will not prevent a State, which is otherwise eligible, from qualifying. (2) Discontinuation of any of the con ditions described in paragraph (a)(1)(i) of this section, or repeated outbreaks of pullorum or typhoid occur in hatch ery supply flocks described in para graph (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 classi fication. 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 accord ance with rules of practice adopted by the Administrator. [40 FR 1504, Jan. 8, 1975. Redesignated at 44 FR 61586, Oct. 26, 1979, and amended at 54 FR 23957, June 5, 1989; 67 FR 8469, Feb. 25, 2002; 76 FR 15794, Mar. 22, 2011] Subpart F—Special Provisions for Ostrich, Emu, Rhea, and Cas sowary Breeding Flocks and Products SOURCE: 63 FR 40010, July 27, 1998, unless otherwise noted. § 145.61 Definitions. Except where the context otherwise requires, for the purposes of this sub part the following terms shall be con strued, respectively, to mean: Chicks. Newly hatched ostriches, emus, rheas, or cassowaries. VerDate Sep<11>2014 13:56 Feb 14, 2018 Jkt 244028 PO 00000 Frm 00939 Fmt 8010 Sfmt 8010 Q:\09\9V1.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 930 9 CFR Ch. I (1–1–18 Edition) § 145.62 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] § 145.62 Participation. Participating flocks of ostriches, emus, rheas, and cassowaries, and the eggs and chicks produced from them, shall comply with the applicable gen eral provisions of subpart A of this part and the special provisions of this sub part. (a) Started poultry shall lose their identity under Plan terminology when not maintained by Plan participants under the conditions prescribed in § 145.5(a). (b) Hatching eggs produced by pri mary breeding flocks shall be fumi gated or otherwise sanitized in accord ance with part 147 of this subchapter. (c) Any nutritive material provided to chicks must be free of the avian pathogens that are officially rep resented in the Plan disease classifica tions listed in § 145.10. [63 FR 40010, July 27, 1998, as amended at 65 FR 8019, Feb. 17, 2000; 79 FR 38759, July 9, 2014] § 145.63 Terminology and classifica tion; flocks and products. Participating flocks, and the eggs and baby poultry produced from them, that have met the respective require ments 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-ty phoid where applicable.) (1) It has been officially blood tested within the past 12 months with no reac tors. (2) It is a breeding flock that meets one of the following criteria: (i)(A) It is a multiplier or primary breeding flock of fewer than 300 birds in which a sample of 10 percent of the birds in a flock or at least 1 bird from each pen, whichever is more, has been officially tested for pullorum-typhoid within the past 12 months with no reac tors; or (B) It is a multiplier or primary breeding flock of 300 birds or more in which a sample of a minimum of 30 birds has been officially tested for pul lorum-typhoid within the past 12 months with no reactors. (ii) It is a flock that has already been designated U.S. Pullorum-Typhoid Clean and uses a subsequent bacterio logical examination monitoring pro gram of hatcher debris or eggs for os triches, emus, rheas, or cassowaries ac ceptable to the Official State Agency and approved by the Service in lieu of annual blood testing. (iii) It is a multiplier breeding flock located in a State that has been deemed to be a U.S. Pullorum-Typhoid Clean State for the past 3 years, and during which time no isolation of pul lorum or typhoid has been made that can be traced to a source in that State, that uses a bacteriological examina tion monitoring program of hatcher de bris or eggs or a serological examina tion monitoring program acceptable to the Official State Agency and approved by the Service in lieu of annual blood testing. (b) U.S. Avian Influenza Clean. This program is intended to be the basis from which the breeding-hatchery in dustry may conduct a program for the prevention and control of avian influ enza. It is intended to determine the presence of avian influenza in all os trich, emu, rhea, and cassowary breed ing flocks through routine serological surveillance of each participating breeding flock. Acceptable tests in clude antigen and antibody detection tests, as approved by the Official State Agency. A flock, and the hatching eggs and chicks produced from it, will qual ify for this classification when the Offi cial State Agency determines that it has met one of the following require ments: (1) It is a primary breeding flock in which 10 percent of the flock, up to a maximum of 30 birds, has been tested negative for type A influenza virus with all pens represented equally and when the tested birds are more than 4 months of age. Positive samples shall VerDate Sep<11>2014 13:56 Feb 14, 2018 Jkt 244028 PO 00000 Frm 00940 Fmt 8010 Sfmt 8010 Q:\09\9V1.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 931 Animal and Plant Health Inspection Service, USDA § 145.73 be further tested by an authorized lab oratory. To retain this classification: (i) A sample of at least 30 birds must be tested negative at intervals of 180 days, or (ii) A sample of less than 10 percent of the birds, up to a maximum of 30 birds, may be tested and found to be negative at any one time if all pens are equally represented and a total of 30 birds are tested within each 180-day pe riod. (2) It is a multiplier breeding flock in which a minimum of 30 birds has been tested negative to type A influenza virus with all pens represented equally and when the tested birds are more than 4 months of age. Positive samples shall be further tested by an authorized laboratory. To retain this classifica tion: (i) A sample of at least 30 birds must be tested negative at intervals of 180 days, or (ii) A sample of at least 10 percent of birds from each pen with all pens being represented must be tested negative at intervals of 180 days; or (iii) A sample of less than 10 percent of the birds may be tested, and found to be negative, at any one time if all pens are equally represented and a total of 10 percent of the birds are test ed within each 180-day period. [63 FR 40010, July 27, 1998, as amended at 65 FR 8019, Feb. 17, 2000; 72 FR 1420, Jan. 12, 2007; 74 FR 14715, Apr. 1, 2009] Subpart G—Special Provisions for Primary Egg-Type Chicken Breeding Flocks and Prod ucts SOURCE: 72 FR 1420, Jan. 12, 2007, unless otherwise noted. § 145.71 Definitions. Except where the context otherwise requires, for the purposes of this sub part the following terms shall be con strued, respectively, to mean: Chicks. Newly hatched chickens. Primary egg-type chicken breeding flocks. Foundation flocks that are com posed of pedigree, great-grandparent, and grandparent stock that has been developed for egg production and are maintained for the principal purpose of producing multiplier breeding chicks used to produce table egg layers. Started chickens. Young chickens (chicks, pullets, cockerels, capons) which have been fed and watered and are less than 6 months of age. § 145.72 Participation. Participating flocks of primary egg type chickens, and the eggs and chicks produced from them, shall comply with the applicable general provisions of subpart A of this part and the special provisions of this subpart G. (a) Started chickens shall lose their identity under Plan terminology when not maintained by Plan participants under the conditions prescribed in § 145.5(a). (b) Hatching eggs produced by pri mary breeding flocks should be nest clean. They may be fumigated in ac cordance with part 147 of this sub chapter or otherwise sanitized. (c) Any nutritive material provided to chicks must be free of the avian pathogens that are officially rep resented in the Plan disease classifica tions listed in § 145.10. [72 FR 1420, Jan. 12, 2007, as amended at 79 FR 38759, July 9, 2014] § 145.73 Terminology and classifica tion; flocks and products. Participating flocks, and the eggs and chicks produced from them, which have met the respective requirements specified in this section, may be des ignated by the following terms and the corresponding designs illustrated in § 145.10: (a) [Reserved] (b) U.S. Pullorum-Typhoid Clean. A flock in which freedom from pullorum and typhoid has been demonstrated to the Official State Agency under the criteria in paragraph (b)(1) or (b)(2) of this section: Provided, That a flock qualifying by means of a blood test shall be tested within the past 12 months, except that the retesting of a participating flock which is retained for more than 12 months shall be con ducted a minimum of 4 weeks after the induction of molt. (See § 145.14 relating to the official blood test where applica ble.) (1) It has been officially blood tested with no reactors. VerDate Sep<11>2014 13:56 Feb 14, 2018 Jkt 244028 PO 00000 Frm 00941 Fmt 8010 Sfmt 8010 Q:\09\9V1.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 932 9 CFR Ch. I (1–1–18 Edition) § 145.73 (2) It is a primary breeding flock that meets the following criteria: (i) The primary breeding flock is lo cated in a State in which pullorum dis ease or fowl typhoid is not known to exist nor to have existed in hatchery supply flocks during the preceding 12 months and in which it has been deter mined by the Service that: (A) All hatcheries within the State are qualified as ‘‘National Plan Hatch eries’’ or have met equivalent require ments for pullorum-typhoid control under official supervision; (B) All hatchery supply flocks within the State are qualified as U.S. Pul lorum-Typhoid Clean or have met equivalent requirements for pullorum typhoid control under official super vision: Provided, That if other domes ticated fowl, except waterfowl, are maintained on the same premises as the participating flock, freedom from pullorum-typhoid infection shall be demonstrated by an official blood test of each of these fowl; (C) All shipments of products other than U.S. Pullorum-Typhoid Clean, or equivalent, into the State are prohib ited; (D) All persons performing poultry disease diagnostic services within the State are required to report to the Offi cial State Agency within 48 hours the source of all poultry specimens from which S. pullorum or S. gallinarum is isolated; (E) All reports of any disease out break involving a disease covered under the Plan are promptly followed by an investigation by the Official State Agency to determine the origin of the infection; Provided, That if the origin of the infection involves another State, or if there is exposure to poultry in another State from the infected flock, then officials administering the National Poultry Improvement Plan will conduct an investigation; (F) All flocks found to be infected with pullorum or typhoid are quar antined 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 dem onstrate pullorum or typhoid infection; (G) All poultry, including exhibition, exotic, and game birds, but excluding waterfowl, going to public exhibition shall come from U.S. Pullorum-Ty phoid Clean or equivalent flocks, or have had a negative pullorum-typhoid test within 90 days of going to public exhibition; and (H) Discontinuation of any of the conditions or procedures described in paragraphs (b)(2)(i)(A) through (b)(2)(i)(G) of this section, or the occur rence of repeated outbreaks of pul lorum 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 in vestigation has been made by the Serv ice and the Official State Agency has been given an opportunity to present its views; and (ii) In the primary breeding flock, a sample of 300 birds from flocks of more than 300, and each bird in flocks of 300 or less, has been officially tested for pullorum-typhoid with no reactors: Provided, That a bacteriological exam ination monitoring program acceptable to the Official State Agency and ap proved by the Service may be used in lieu of blood testing. (c) U.S. M. Gallisepticum Clean. (1) A flock maintained in accordance with part 147 of this subchapter with respect to Mycoplasma isolation, sanitation, and management and in which freedom from M. gallisepticum has been dem onstrated under the criteria specified in paragraph (c)(1)(i) of this section. (i) It is a flock in which all birds or a sample of at least 300 birds has been tested for M. gallisepticum as provided in § 145.14(b) 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 fewer 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. (ii) [Reserved] (2) A participant handling U.S. M. Gallisepticum Clean products shall VerDate Sep<11>2014 13:56 Feb 14, 2018 Jkt 244028 PO 00000 Frm 00942 Fmt 8010 Sfmt 8010 Q:\09\9V1.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 933 Animal and Plant Health Inspection Service, USDA § 145.73 handle only products of equivalent sta tus. (3) U.S. M. Gallisepticum Clean chicks shall be boxed in clean boxes and delivered in trucks that have been cleaned and disinfected in accordance with part 147. (d) U.S. S. Enteritidis Clean. This clas sification is intended for primary egg type breeders wishing to assure their customers that the hatching eggs and multiplier chicks produced are cer tified free of Salmonella enteritidis. (1) A flock and the hatching eggs and chicks produced from it which have met the following requirements as de termined by the Official State Agency: (i) The flock originated from a U.S. S. Enteritidis Clean flock, or meco nium from the chick boxes and a sam ple of chicks that died within 7 days after hatching are examined bacterio logically for salmonella at an author ized 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 ei ther 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 manufac tured in pellet form and crumbled: Pro vided, That mash feed may contain nonpelleted APPI animal protein prod uct supplements if the finished feed is treated with a salmonella control prod uct approved by the U.S. Food and Drug Administration. (iii) Feed shall be stored and trans ported in such a manner as to prevent possible contamination; (iv) The flock is maintained in ac cordance with part 147 of this sub chapter with respect to flock sanita tion, cleaning and disinfection, and Salmonella isolation, sanitation, and management. Rodents and other pests should be effectively controlled; (v) Environmental samples shall be collected from the flock by an Author ized Agent, in accordance with part 147 of this subchapter, when the flock is 2 to 4 weeks of age. The samples shall be examined bacteriologically for group D salmonella at an authorized labora tory. 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 pul lorum-typhoid antigen, one of the fol lowing options must be utilized. (A) Administer the vaccine after the pullorum-typhoid testing is done as de scribed 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 de scribed in paragraph (d)(1)(vii) of this section, vaccinate the banded, non-vac cinated birds. (vii) Blood samples from 300 non-vac cinated 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 sub mitted to an authorized laboratory and examined for the presence of group D salmonella, in accordance with part 147 of this subchapter. Cultures from posi tive samples shall be serotyped. (viii) Hatching eggs are collected as quickly as possible and are handled as described in § 147.22 of this subchapter and are sanitized or fumigated (see § 147.25 of this subchapter). (ix) Hatching eggs produced by the flock are incubated in a hatchery whose sanitation is maintained in ac cordance with part 147 of this sub chapter and sanitized either by a proce dure approved by the Official State VerDate Sep<11>2014 13:56 Feb 14, 2018 Jkt 244028 PO 00000 Frm 00943 Fmt 8010 Sfmt 8010 Q:\09\9V1.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 934 9 CFR Ch. I (1–1–18 Edition) § 145.73 Agency or in accordance with part 147 of this subchapter. (2) A flock shall not be eligible for this classification if Salmonella enteritidis serotype 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 ex amination for SE in an authorized lab oratory, in accordance with part 147 of this subchapter, 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 bacterio logical examination of a second sam ple, equal in size to the first sample, from the flock. If no SE is recovered from any of the specimens in the sec ond sample, the flock will be eligible for the classification. (3) A non-vaccinated flock shall be el igible for this classification if SE 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 posi tive samples are found. (4) In order for a hatchery to sell products of this classification, all prod ucts handled shall meet the require ments of the classification. (5) This classification may be re voked by the Official State Agency if the participant fails to follow rec ommended corrective measures. The Official State Agency shall not revoke the participant’s classification until the participant has been given an op portunity for a hearing in accordance with rules of practice adopted by the Official State Agency. (e) U.S. M. Synoviae Clean. (1) A flock maintained in accordance with part 147 of this subchapter with respect to Mycoplasma isolation, sanitation, and management and in which freedom from M. synoviae has been dem onstrated under the criteria specified in paragraph (e)(1)(i) 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 sam ple comprised of fewer 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. (ii) [Reserved] (2) A participant handling U.S. M. Synoviae Clean products shall handle only products of equivalent status. (3) U.S. M. Synoviae Clean chicks shall be boxed in clean boxes and deliv ered in trucks that have been cleaned and disinfected in accordance with part 147 of this subchapter. (f) U.S. Avian Influenza Clean. This program is intended to be the basis from which the breeding-hatchery in dustry may conduct a program for the prevention and control of avian influ enza. It is intended to determine the presence of avian influenza in primary breeding chickens through routine sur veillance of each participating breed ing flock. A flock and the hatching eggs and chicks produced from it will qualify for this classification when the Official State Agency determines that they have met the following require ments: (1) It is a primary breeding flock in which a minimum of 30 birds have been tested and found negative for avian in fluenza 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 nega tive, at any one time if all pens are equally represented and a total of 30 birds is tested within each 90-day pe riod; or (iii) The flock is tested as provided in § 145.14(d) at intervals of 30 days or less and found to be negative, and a total of 30 samples are collected and tested within each 90-day period; and (2) A sample of at least 11 birds must be tested and found negative for avian influenza within 21 days prior to move ment to slaughter. [72 FR 1420, Jan. 12, 2007, as amended at 76 FR 15794, Mar. 22, 2011; 79 FR 38759, July 9, 2014] VerDate Sep<11>2014 13:56 Feb 14, 2018 Jkt 244028 PO 00000 Frm 00944 Fmt 8010 Sfmt 8010 Q:\09\9V1.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 935 Animal and Plant Health Inspection Service, USDA § 145.74 § 145.74 Terminology and classifica tion; compartments. (a) U.S. Avian Influenza Clean Com partment. This program is intended to be the basis from which the primary egg-type chicken breeding-hatchery in dustry may demonstrate the existence and implementation of a program that has been approved by the Official State Agency and the Service to establish a compartment consisting of a primary breeding-hatchery company that is free of H5/H7 avian influenza (AI), also re ferred to as notifiable avian influenza (NAI). This compartment has the pur pose of protecting the defined sub population and avoiding the introduc tion and spread of NAI within that sub population by prohibiting contact with other commercial poultry operations, other domestic and wild birds, and other intensive animal operations. The program shall consist of the following: (1) Definition of the compartment. Based on the guidelines established by the World Organization for Animal Health (OIE) in the Terrestrial Animal Health Code and the guidelines in this paragraph (a), the primary breeder company will define the compartment with respect to NAI. Specifically, the company will use a comprehensive bio security program to define the com partment as a subpopulation of poultry with a health status for NAI that is separate from birds and poultry outside the compartment. The Official State Agency and the Service must first ap prove all documentation submitted by the company to substantiate the de fined compartment as adequate to qualify for epidemiological separation from other potential sources of infec tion of NAI. Guidelines for the defini tion of the compartment include: (i) Definition and description of the subpopulation of birds and their health status. All birds included in the com partment must be U.S. Avian Influenza Clean in accordance with § 145.73(f). The poultry must also be located in a State that has an initial State response and containment plan approved by APHIS under § 56.10 of this chapter and that participates in the diagnostic surveil lance program for H5/H7 low pathoge nicity AI as described in § 145.15. Within the compartment, all official tests for AI, as described in § 145.14(d), must be conducted in State or Federal labora tories or in NPIP authorized labora tories that meet the minimum stand ards described in § 147.52 of this sub chapter. In addition, the company must provide to the Service upon re quest any relevant historical and cur rent NAI-related data for reference re garding surveillance for the disease within the compartment. Upon request, the Official State Agency may provide such data for other commercial poultry populations located in the State. (ii) Description of animal identification and traceability processes. The primary breeder company must also include a description of its animal identification and traceability records, including ex amples of Veterinary Services (VS) Form 9–5, ‘‘Report of Hatcheries, Deal ers and Independent Flocks’’; VS Form 9–2, ‘‘Flock Selection and Testing Re port’’; VS Form 9–3, ‘‘Report of Sales of Hatching Eggs, Chicks and Poults’’; VS Form 9–9, ’’ Hatchery Inspection Re port’’; set and hatch records; egg re ceipts; and egg/chick invoices for the subpopulation. Documentation must also include breed identification (NPIP stock code). The Service should ensure that an effective flock identification system and traceability system are in place. (iii) Definition and description of the physical components or establishments of the defined compartment. The primary breeder company must provide docu mentation establishing that the de fined compartment is epidemiologically separated from other poultry and bird populations. The doc umentation must be approved by the Official State Agency and the Service as indicating adequate epidemiological separation to maintain the compart ment’s separate health status with re spect to NAI. The documentation should include descriptions of: (A) The physical and spatial factors that separate the compartment from surrounding bird populations and affect the biosecurity status of the compart ment. (B) Relevant environmental factors that may affect exposure of the birds to AI. (C) The functional boundary and fencing that are used to control access to the compartment. VerDate Sep<11>2014 13:56 Feb 14, 2018 Jkt 244028 PO 00000 Frm 00945 Fmt 8010 Sfmt 8010 Q:\09\9V1.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 936 9 CFR Ch. I (1–1–18 Edition) § 145.74 (D) Facilities and procedures to pre vent access by wild birds and to pro vide separation from other relevant hosts. (E) The relevant infrastructural fac tors that may affect exposure to AI, in cluding the construction and design of buildings or physical components, cleaning and disinfection of buildings and physical components between pro duction groups with quality assurance verification, cleaning and disinfection of equipment, and introduction of equipment or material into the com partment. (iv) Definition and description of the functional relationships between compo nents of the defined compartment. Func tional relationships between compo nents of the compartment include traf fic movement and flow at and among premises, personnel movement at and among premises, exposure to live bird populations, and any other factors that could affect biosecurity of the com partment. All physical components of the compartment must be maintained in compliance with hygiene and bio security procedures for poultry pri mary breeding flocks and hatcheries in accordance with part 147 of this sub chapter. In addition, the company must provide a biosecurity plan for the compartment and all included compo nents. The biosecurity plan should in clude but not be limited to: (A) Requirements that company em ployees and contract growers limit their contact with live birds outside the compartment. (B) An education and training pro gram for company employees and con tractors. (C) Standard operating procedures for company employees, contractors, and outside maintenance personnel. (D) Requirements for company em ployees and non-company personnel who visit any premises within the com partment. (E) Company veterinary infrastruc ture to ensure flock monitoring and disease diagnosis and control measures. (F) Policies for management of vehi cles and equipment used within the compartment to connect the various premises. (G) Farm site requirements (location, layout, and construction). (H) Pest management program. (I) Cleaning and disinfection process. (J) Requirements for litter and dead bird removal and/or disposal. (v) Description of other factors impor tant for maintaining the compartment. The company veterinary infrastructure will assess sanitary measures, environ mental risk factors, and management and husbandry practices that relate to the separation of the compartment and the health status of the birds contained within the compartment that may af fect risk of exposure to NAI. This as sessment must include a description of internal monitoring and auditing sys tems (e.g., quality assurance and qual ity control programs) to demonstrate the effectiveness of the compartment. Upon request, the Service will provide the company with information on the epidemiology of NAI and the associated risk pathways in which the compo nents of the compartment are located. (vi) Approval or denial. Based on the documentation provided under this paragraph (a)(1), as well as any other information the Service and the Offi cial State Agency determine to be nec essary, the Service and the Official State Agency will approve or deny the classification of the compartment as U.S. Avian Influenza Clean. (2) Company activities for maintenance of the compartment. (i) The primary breeder company’s management of bio security, surveillance, and disease con trol efforts must be uniform and equiv alent among all components that are a part of the compartment. Oversight and inspection of these management practices must be conducted by the company’s licensed, accredited veteri narians. (ii) Veterinary staff from the Official State Agency and NPIP staff will work in partnership with licensed, accred ited veterinarians to train and certify auditors through Service-approved workshops. The trained auditors will conduct biosecurity and operational audits at least once every 2 years to ensure the integrity of the compart ment. These audits will include evalua tion of the critical control points and standard operating practices within the compartment, verification of the health status of the flock(s) contained VerDate Sep<11>2014 13:56 Feb 14, 2018 Jkt 244028 PO 00000 Frm 00946 Fmt 8010 Sfmt 8010 Q:\09\9V1.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 937 Animal and Plant Health Inspection Service, USDA § 145.74 within the compartment, and examina tion of the biosecurity and manage ment system of the integrated compo nents of the compartment. (iii) In addition, the company must demonstrate compliance with para graph (a)(1) of this section for remain ing in the U.S. Avian Influenza Clean classification, surveillance for NAI within the compartment, and con ducting tests in State or Federal lab oratories or in NPIP authorized labora tories. Accredited veterinarians are re sponsible for the enforcement of active and passive surveillance of NAI in pri mary breeder flocks. Baseline health status must be maintained for all flocks or subpopulations within the compartment, indicating the dates and negative results of all avian influenza surveillance and monitoring testing, the dates and history of last disease oc currence (if any), the number of out breaks, and the methods of disease con trol that were applied. (iv) Documentation will be main tained in the company’s database and will be verified as required by the Serv ice and/or the Official State Agency. (3) Service and Official State Agency activities for maintenance of the compart ment. The Service will work in coopera tion with the Official State Agencies to ensure the continued integrity of any recognized compartments. Activities include: (i) Oversight of the establishment and management of compartments; (ii) Establishment of effective part nerships between the Service, the Plan, and the primary breeder industry; (iii) Approval or denial of classifica tion of compartments as U.S. Avian In fluenza Clean Compartments under paragraph (a)(1) of this section; (iv) Official certification of the health status of the compartment, and commodities that may be traded from it through participation in the Plan for avian diseases, including the U.S. Avian Influenza Clean program as de scribed in § 145.73(f) and diagnostic sur veillance for H5/H7 low pathogenicity AI as described in § 145.15; (v) Conducting audits of compart ments at least once every 2 years to: (A) Confirm that the primary breed ing company’s establishments are epidemiologically distinct and path ways for the introduction of disease into the compartment are closed through routine operational proce dures; and (B) Evaluate and assess the manage ment and husbandry practices relating to biosecurity to determine whether they are in compliance with hygiene and biosecurity procedures for poultry primary breeding flocks and hatcheries in accordance with part 147 of this sub chapter; (vi) Providing, upon request, model plans for management and husbandry practices relating to biosecurity in ac cordance with part 147 of this sub chapter, risk evaluations in conjunc tion with the primary breeder industry (including disease surveillance such as VS Form 9–4, ‘‘Summary of Breeding Flock Participation’’), and diagnostic capability summaries and systems for initial State response and containment plans in accordance with § 56.10 of this chapter; and (vii) Publicizing and sharing com partment information with inter national trading partners, upon re quest, to establish approval and rec ognition of the compartment, including timeliness and accuracy of disease re porting and surveillance measures as described in §§ 145.15 and 145.73(f). (4) Emergency response and notifica tion. In the case of a confirmed positive of NAI in the subpopulation of the compartment, the management of the compartment must notify the Service. The Service will immediately suspend the status of the compartment. A com partment will be eligible to resume trade with importing countries only after the compartment has adopted the necessary measures to reestablish the biosecurity level and confirm that NAI is not present in the compartment and the Service has reevaluated the man agement and biosecurity measures of the compartment and approved said compartment for trade. (b) [Reserved] [79 FR 38760, July 9, 2014] VerDate Sep<11>2014 13:56 Feb 14, 2018 Jkt 244028 PO 00000 Frm 00947 Fmt 8010 Sfmt 8010 Q:\09\9V1.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 938 9 CFR Ch. I (1–1–18 Edition) § 145.81 Subpart H—Special Provisions for Primary Meat-Type Chicken Breeding Flocks and Prod ucts SOURCE: 72 FR 1422, Jan. 12, 2007, unless otherwise noted. § 145.81 Definitions. Except where the context otherwise requires, for the purposes of this sub part the following terms shall be con strued, respectively, to mean: Chicks. Newly hatched chickens. Primary meat-type chicken breeding flocks. Foundation flocks that are com posed of pedigree, great-grandparent, and grandparent stock that has been developed for meat production and are maintained for the principal purpose of producing multiplier breeding chicks used to produce commercial broilers. Started chickens. Young chickens (chicks, pullets, cockerels, capons) which have been fed and watered and are less than 6 months of age. § 145.82 Participation. Participating flocks of primary meat-type chickens, and the eggs and chicks produced from them, shall com ply with the applicable general provi sions of subpart A of this part and the special provisions of this subpart H. (a) Started chickens shall lose their identity under Plan terminology when not maintained by Plan participants under the conditions prescribed in § 145.5(a). (b) Hatching eggs produced by pri mary breeding flocks should be nest clean. They may be fumigated in ac cordance with part 147 of this sub chapter or otherwise sanitized. (c) Any nutritive material provided to chicks must be free of the avian pathogens that are officially rep resented in the Plan disease classifica tions listed in § 145.10. [72 FR 1422, Jan. 12, 2007, as amended at 79 FR 38762, July 9, 2014] § 145.83 Terminology and classifica tion; flocks and products. Participating flocks, and the eggs and chicks produced from them, which have met the respective requirements specified in this section, may be des ignated by the following terms and the corresponding designs illustrated in § 145.10: (a) [Reserved] (b) U.S. Pullorum-Typhoid Clean. A flock in which freedom from pullorum and typhoid has been demonstrated to the Official State Agency under the criteria in paragraph (b)(1) or (b)(2) of this section: Provided, That a flock qualifying by means of a blood test shall be tested within the past 12 months, except that the retesting of a participating flock which is retained for more than 12 months shall be con ducted a minimum of 4 weeks after the induction of molt. (See § 145.14 relating to the official blood test where applica ble.) (1) It has been officially blood tested with no reactors. (2) It is a primary breeding flock that meets the following criteria: (i) The primary breeding flock is lo cated in a State in which pullorum dis ease or fowl typhoid is not known to exist nor to have existed in hatchery supply flocks within the State during the preceding 12 months and in which it has been determined by the Service that: (A) All hatcheries within the State are qualified as ‘‘National Plan Hatch eries’’ or have met equivalent require ments for pullorum-typhoid control under official supervision; (B) All hatchery supply flocks within the State are qualified as U.S. Pul lorum-Typhoid Clean or have met equivalent requirements for pullorum typhoid control under official super vision: Provided, That if other domes ticated fowl, except waterfowl, are maintained on the same premises as the participating flock, freedom from pullorum-typhoid infection shall be demonstrated by an official blood test of each of these fowl; (C) All shipments of products other than U.S. Pullorum-Typhoid Clean, or equivalent, into the State are prohib ited; (D) All persons performing poultry disease diagnostic services within the State are required to report to the Offi cial State Agency within 48 hours the source of all poultry specimens from which S. pullorum or S. gallinarum is isolated; VerDate Sep<11>2014 13:56 Feb 14, 2018 Jkt 244028 PO 00000 Frm 00948 Fmt 8010 Sfmt 8010 Q:\09\9V1.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 939 Animal and Plant Health Inspection Service, USDA § 145.83 (E) All reports of any disease out break involving a disease covered under the Plan are promptly followed by an investigation by the Official State Agency to determine the origin of the infection; Provided, That if the origin of the infection involves another State, or if there is exposure to poultry in another State from the infected flock, then officials administering the National Poultry Improvement Plan will conduct an investigation; (F) All flocks found to be infected with pullorum or typhoid are quar antined until marketed or destroyed under the supervision of the Official State Agency, or until subsequently blood tested following the procedure for reacting flocks as contained in § 145.14(a)(5) of this subchapter, and all birds fail to demonstrate pullorum or typhoid infection; (G) All poultry, including exhibition, exotic, and game birds, but excluding waterfowl, going to public exhibition shall come from U.S. Pullorum-Ty phoid Clean or equivalent flocks, or have had a negative pullorum-typhoid test within 90 days of going to public exhibition; and (H) Discontinuation of any of the conditions or procedures described in paragraphs (b)(2)(i)(A) through (b)(2)(i)(G) of this section, or the occur rence of repeated outbreaks of pul lorum 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 in vestigation has been made by the Serv ice and the Official State Agency has been given an opportunity to present its views; and (ii) In the primary breeding flock, a sample of 300 birds from flocks of more than 300, and each bird in flocks of 300 or less, has been officially tested for pullorum-typhoid with no reactors: Provided, That a bacteriological exam ination monitoring program acceptable to the Official State Agency and ap proved by the Service may be used in lieu of blood testing. (c) U.S. M. Gallisepticum Clean. (1) A flock maintained in accordance with part 147 of this subchapter with respect to Mycoplasma isolation, sanitation, and management and in which freedom from M. gallisepticum has been dem onstrated under the criteria specified in paragraph (c)(1)(i) of this section. (i) It is a flock in which all birds or a sample of at least 300 birds has been tested for M. gallisepticum as provided in § 145.14(b) of this subchapter when more than 4 months of age: Provided, That to retain this classification, a minimum of 40 birds shall be tested at intervals of not more than 28 days, and a total of at least 150 birds shall be tested within each 90-day period. (ii) [Reserved] (2) A participant handling U.S. M. Gallisepticum Clean products must handle only products of equivalent sta tus. (3) U.S. M. Gallisepticum Clean chicks shall be boxed in clean boxes and delivered in trucks that have been cleaned and disinfected in accordance with part 147 of this subchapter. (d) U.S. M. Synoviae Clean. (1) A flock maintained in accordance with part 147 of this subchapter with respect to Mycoplasma isolation, sanitation, and management and in which freedom from M. synoviae has been dem onstrated under the criteria specified in paragraph (d)(1)(i) of this section. (i) It is a flock in which all birds or a sample of at least 300 birds has been tested for M. synoviae as provided in § 145.14(b) of this subchapter when more than 4 months of age: Provided, That to retain this classification, a sample of at least 40 birds shall be tested at in tervals of not more than 28 days, and a total of at least 150 birds shall be test ed within each 90-day period. (ii) [Reserved] (2) A participant handling U.S. M. Synoviae Clean products shall handle only products of equivalent status. (3) U.S. M. Synoviae Clean chicks shall be boxed in clean boxes and deliv ered in trucks that have been cleaned and disinfected in accordance with part 147 of this subchapter. (e) U.S. S. Enteritidis Clean. This clas sification is intended for primary meat-type breeders wishing to assure their customers that the chicks pro duced are certified free of Salmonella enteritidis. VerDate Sep<11>2014 13:56 Feb 14, 2018 Jkt 244028 PO 00000 Frm 00949 Fmt 8010 Sfmt 8010 Q:\09\9V1.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 940 9 CFR Ch. I (1–1–18 Edition) § 145.83 (1) A flock and the hatching eggs and chicks produced from it shall be eligi ble for this classification if they meet the following requirements, as deter mined by the Official State Agency: (i) The flock originated from a U.S. S. Enteritidis Clean flock, or one of the following samples has been examined bacteriologically for S. enteritidis at an authorized laboratory in accordance with part 147 of this subchapter and any group D Salmonella samples have been serotyped: (A) A sample of chick papers, hatcher tray swabs, or fluff collected and cul tured in accordance with part 147 of this subchapter; and (B) Samples of intestinal and liver or spleen tissues from a minimum of 30 chicks that died within 7 days after hatching and have been preserved daily by freezing prior to shipment to an au thorized laboratory. (ii) The flock is maintained in com pliance with isolation, sanitation, and management procedures for Sal monella in accordance with part 147 of this subchapter. (iii) Environmental samples are col lected from the flock by or under the supervision of an Authorized Agent, in accordance with part 147 of this sub chapter, when the flock reaches 4 months of age and every 30 days there after. Once the flock is in egg produc tion and chicks are hatching from it, the samples must include at least 4 in dividual test assay results every 30 days in flocks of more than 500 birds or 2 individual assays per month in flocks of 500 birds or fewer. One of these re sults must come from samples col lected from hatched chicks at a par ticipating hatchery derived from said flock. These individual test assays may be derived from pooled samples from the farm or hatchery in accordance with part 147 of this subchapter, but must be run as separate test assays in the laboratory. The environmental samples shall be examined bacterio logically for group D Salmonella at an authorized laboratory, and cultures from group D positive samples shall be serotyped. (iv) 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 part 147 of this subchapter. Cultures from group D positive samples shall be serotyped. (v) Hatching eggs produced by the flock are collected as quickly as pos sible and their sanitation is main tained in accordance with part 147 of this subchapter. (vi) Hatching eggs produced by the flock are incubated in a hatchery whose sanitation is maintained in ac cordance with part 147 of this sub chapter, and the hatchery must have been sanitized either by a procedure approved by the Official State Agency or by fumigation in accordance with part 147 of this subchapter. (2) If Salmonella enteritidis serotype enteritidis (SE) is isolated from a speci men taken from a bird in the flock, ex cept as provided in paragraph (e)(3) of this section, the flock shall not be eli gible for this classification. (3) If SE is isolated from an environ mental sample collected from the flock in accordance with paragraph (e)(1)(iii) of this section, an additional environ mental sampling and 25 live cull birds or fresh dead birds (if present), or other randomly selected live birds if fewer than 25 culls can be found in the flock, must be bacteriologically examined for SE in accordance with part 147 of this subchapter. If only 1 bird from the 25 bird sample is found positive for SE., the participant may request bacterio logical examination of a second 25-bird sample from the flock. In addition, if the flock with the SE isolation is in egg production and eggs are under in cubation, the next four consecutive hatches shall be examined bacterio logically in accordance with part 147 of this subchapter. Samples shall be col lected from all of the hatching unit’s chick trays and basket trays of hatch ing eggs, or from all chick box papers from the flock, and tested, pooling the samples into a minimum of 10 separate assays. Any followup hatchery-positive SE isolations shall result in dis continuation of subsequent hatches until the flock status is determined by VerDate Sep<11>2014 13:56 Feb 14, 2018 Jkt 244028 PO 00000 Frm 00950 Fmt 8010 Sfmt 8010 Q:\09\9V1.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 941 Animal and Plant Health Inspection Service, USDA § 145.83 bird culture. The flock will be disquali fied for the U.S. S. Enteritidis Clean classification if a bird or subsequent flock environmental assay results in isolation of SE. (4) In order for a hatchery to sell products of this classification, all prod ucts handled by the hatchery must meet the requirements of this para graph. (5) This classification may be re voked by the Official State Agency if the participant fails to follow rec ommended corrective measures. The Official State Agency shall not revoke the participant’s classification until the participant has been given an op portunity for a hearing in accordance with rules of practice adopted by the Official State Agency. (6) A pedigree, experimental, great grandparent, or grandparent flock that is removed from the U.S. S. Enteritidis Clean program may be reinstated whenever the following conditions are met: (i) The owner attests that corrective measures have been implemented, which may include one or more of the following: (A) Test and slaughter infected birds based on blood tests of every bird in the flock, with either pullorum antigen or by a federally licensed Salmonella enteritidis enzyme-linked immunosorbent assay (ELISA) test when the flock is more than 4 months of age. (B) Perform other corrective actions including, but not limited to, vaccina tion, medication, cleaning and disinfec tion of houses, rodent control, and movement of uninfected birds to prem ises that have been determined to be environmentally negative for S. enteritidis in accordance with par 147 of this subchapter. (C) One hundred percent of blood samples from the birds moved to the clean premises are tested negative for Salmonella pullorum and group D Sal monella. All birds with positive or in conclusive reactions, up to a maximum of 25 birds, shall be submitted to an au thorized laboratory and examined for the presence of group D Salmonella, in accordance with part 147 of this sub chapter. Cultures from positive sam ples shall be serotyped. (D) Two consecutive environmental drag swabs taken at the clean premises collected in accordance with part 147 of this subchapter 4 weeks apart are nega tive 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 classifica tion if the flock is tested in accordance with paragraph (e)(1)(v) of this section every 30 days and no positive samples are found and the flock meets the re quirements set forth in § 145.83(e). (f) U.S. Salmonella Monitored. This program is intended to be the basis from which the breeding-hatching in dustry may conduct a program for the prevention and control of salmonel losis. It is intended to reduce the inci dence of Salmonella organisms in hatch ing eggs and chicks through an effec tive and practical sanitation program at the breeder farm and in the hatch ery. 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 deter mined by the Official State Agency. (i) Measures shall be implemented to control Salmonella challenge through feed, feed storage, and feed transport. (ii) Chicks shall be hatched in a hatchery whose sanitation is main tained in accordance with part 147 of this subchapter and sanitized or fumi gated in accordance with part 147 of this subchapter. (iii) An Authorized Agent shall take environmental samples from the hatch ery every 30 days; i.e., meconium or chick papers. An authorized laboratory for Salmonella shall examine the sam ples bacteriologically; (iv) An Authorized Agent shall take environmental samples in accordance with part 147 of this subchapter from each flock at 4 months of age and every 30 days thereafter. An authorized lab oratory for Salmonella shall examine the environmental samples bacterio logically. All Salmonella isolates from a flock shall be serogrouped and shall be reported to the Official State Agency on a monthly basis; VerDate Sep<11>2014 13:56 Feb 14, 2018 Jkt 244028 PO 00000 Frm 00951 Fmt 8010 Sfmt 8010 Q:\09\9V1.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 942 9 CFR Ch. I (1–1–18 Edition) § 145.84 (v) Owners of flocks may vaccinate with a paratyphoid vaccine: Provided, That a sample of 350 birds, which will be banded for identification, shall re main unvaccinated until the flock reaches at least 4 months of age to allow for the serological testing re quired under paragraph (f)(1)(iv) of this section. (vi) Any flock entering the produc tion period that is in compliance with all the requirements of § 145.83(f) with no history of Salmonella isolations shall be considered ‘‘Salmonella negative’’ and may retain this definition as long as no environmental or bird Salmonella isolations are identified and confirmed from the flock or flock environment by sampling on 4 separate collection dates over a minimum of a 2-week period. Sampling and testing must be per formed as described in paragraph (f)(1)(iv) of this section. An unconfirmed environmental Salmonella isolation shall not change this Sal monella negative status. (2) The Official State Agency may monitor the effectiveness of the sanita tion practices in accordance with part 147 of this subchapter. (3) In order for a hatchery to sell products of paragraphs (f)(1)(i) through (f)(1)(vi) of this section, all products handled shall meet the requirements of the classification. (4) This classification may be re voked by the Official State Agency if the participant fails to follow rec ommended corrective measures. (g) U.S. Avian Influenza Clean. This program is intended to be the basis from which the breeding-hatchery in dustry may conduct a program for the prevention and control of avian influ enza. It is intended to determine the presence of avian influenza in primary breeding chickens through routine sur veillance of each participating breed ing flock. A flock and the hatching eggs and chicks produced from it will qualify for this classification when the Official State Agency determines that they have met the following require ments: (1) It is a primary breeding flock in which a minimum of 30 birds have been tested negative for antibodies to avian influenza using an approved test as de scribed in § 145.14 when more than 4 months of age. To retain this classi fication: (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 nega tive, at any one time if all pens are equally represented and a total of 30 birds is tested within each 90-day pe riod; or (iii) The flock is tested as provided in § 145.14(d) at intervals of 30 days or less and found to be negative, and a total of 30 samples are collected and tested within each 90-day period; and (2) During each 90-day period, all pri mary spent fowl, up to a maximum of 30, must be tested serologically and found negative for antibodies for avian influenza within 21 days prior to move ment to slaughter. [72 FR 1422, Jan. 12, 2007, as amended at 76 FR 15794, Mar. 22, 2011; 79 FR 38762, July 9, 2014; 79 FR 71624, Dec. 3, 2014; 81 FR 53250, Aug. 12, 2016] § 145.84 Terminology and classifica tion; compartments. (a) U.S. Avian Influenza Clean Com partment. This program is intended to be the basis from which the primary meat-type chicken breeding-hatchery industry may demonstrate the exist ence and implementation of a program that has been approved by the Official State Agency and the Service to estab lish a compartment consisting of a pri mary breeding-hatchery company that is free of H5/H7 avian influenza (AI), also referred to as notifiable avian in fluenza (NAI). This compartment has the purpose of protecting the defined subpopulation and avoiding the intro duction and spread of NAI within that subpopulation by prohibiting contact with other commercial poultry oper ations, other domestic and wild birds, and other intensive animal operations. The program shall consist of the fol lowing: (1) Definition of the compartment. Based on the guidelines established by the World Organization for Animal Health (OIE) in the Terrestrial Animal Health Code and the guidelines in this paragraph (a), the primary breeder company will define the compartment with respect to NAI. Specifically, the VerDate Sep<11>2014 13:56 Feb 14, 2018 Jkt 244028 PO 00000 Frm 00952 Fmt 8010 Sfmt 8010 Q:\09\9V1.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 943 Animal and Plant Health Inspection Service, USDA § 145.84 company will use a comprehensive bio security program to define the com partment as a subpopulation of poultry with a health status for NAI that is separate from birds and poultry outside the compartment. The Official State Agency and the Service must first ap prove all documentation submitted by the company to substantiate the de fined compartment as adequate to qualify for epidemiological separation from other potential sources of infec tion of NAI. Guidelines for the defini tion of the compartment include: (i) Definition and description of the subpopulation of birds and their health status. All birds included in the com partment must be U.S. Avian Influenza Clean in accordance with § 145.83(g). The poultry must also be located in a State that has an initial State re sponse and containment plan approved by APHIS under § 56.10 of this chapter and that participates in the diagnostic surveillance program for H5/H7 low pathogenicity AI as described in § 145.15. Within the compartment, all official tests for AI, as described in § 145.14(d), must be conducted in State or Federal laboratories or in NPIP au thorized laboratories that meet the minimum standards described in § 147.52 of this subchapter. In addition, the company must provide to the Serv ice upon request any relevant histor ical and current NAI-related data for reference regarding surveillance for the disease and the health status of the compartment. Upon request, the Offi cial State Agency may provide such data for other commercial poultry pop ulations located in the State. (ii) Description of animal identification and traceability processes. The primary breeder company must also include a description of its animal identification and traceability records, including ex amples of Veterinary Services (VS) Form 9–5, ‘‘Report of Hatcheries, Deal ers and Independent Flocks’’; VS Form 9–2, ‘‘Flock Selection and Testing Re port’’; VS Form 9–3, ‘‘Report of Sales of Hatching Eggs, Chicks and Poults’’; VS Form 9–9, ’’ Hatchery Inspection Re port’’; set and hatch records; egg re ceipts; and egg/chick invoices for the subpopulation. Documentation must also include breed identification (NPIP stock code). The Service should ensure that an effective flock identification system and traceability system are in place. (iii) Definition and description of the physical components or establishments of the defined compartment. The primary breeder company must provide docu mentation establishing that the de fined compartment is epidemiologically separated from other poultry and bird populations. The doc umentation must be approved by the Official State Agency and the Service as indicating adequate epidemiological separation to maintain the compart ment’s separate health status with re spect to NAI. The documentation should include descriptions of: (A) The physical and spatial factors that separate the compartment from surrounding bird populations and affect the biosecurity status of the compart ment. (B) Relevant environmental factors that may affect exposure of the birds to AI. (C) The functional boundary and fencing that are used to control access to the compartment. (D) Facilities and procedures to pre vent access by wild birds and to pro vide separation from other relevant hosts. (E) The relevant infrastructural fac tors that may affect exposure to AI, in cluding the construction and design of buildings or physical components, cleaning and disinfection of buildings and physical components between pro duction groups with quality assurance verification, cleaning and disinfection of equipment, and introduction of equipment or material into the com partment. (iv) Definition and description of the functional relationships between compo nents of the defined compartment. Func tional relationships between compo nents of the compartment include traf fic movement and flow at and among premises, personnel movement at and among premises, exposure to live bird populations, and any other factors that could affect biosecurity of the com partment. All physical components of the compartment must be maintained in compliance with hygiene and bio security procedures for poultry pri mary breeding flocks and hatcheries in VerDate Sep<11>2014 13:56 Feb 14, 2018 Jkt 244028 PO 00000 Frm 00953 Fmt 8010 Sfmt 8010 Q:\09\9V1.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 944 9 CFR Ch. I (1–1–18 Edition) § 145.84 accordance with part 147 of this sub chapter. In addition, the company must provide a biosecurity plan for the compartment and all included compo nents. The biosecurity plan should in clude but not be limited to: (A) Requirements that company em ployees and contract growers limit their contact with live birds outside the compartment. (B) An education and training pro gram for company employees and con tractors. (C) Standard operating procedures for company employees, contractors, and outside maintenance personnel. (D) Requirements for company em ployees and non-company personnel who visit any premises within the com partment. (E) Company veterinary infrastruc ture to ensure flock monitoring and disease diagnosis and control measures. (F) Policies for management of vehi cles and equipment used within the compartment to connect the various premises. (G) Farm site requirements (location, layout, and construction). (H) Pest management program. (I) Cleaning and disinfection process. (J) Requirements for litter and dead bird removal and/or disposal. (v) Description of other factors impor tant for maintaining the compartment. The company veterinary infrastructure will assess sanitary measures, environ mental risk factors, and management and husbandry practices that relate to the separation of the compartment and the health status of the birds contained within the compartment that may af fect risk of exposure to NAI. This as sessment must include a description of internal monitoring and auditing sys tems (e.g., quality assurance and qual ity control programs) to demonstrate the effectiveness of the compartment. Upon request, the Service will provide the company with information on the epidemiology of NAI and the associated risk pathways in which the compo nents of the compartment are located. (vi) Approval or denial. Based on the documentation provided under this paragraph (a)(1), as well as any other information the Service and the Offi cial State Agency determine to be nec essary, the Service and the Official State Agency will approve or deny the classification of the compartment as U.S. Avian Influenza Clean. (2) Company activities for maintenance of the compartment. (i) The primary breeder company’s management of bio security, surveillance, and disease con trol efforts must be uniform and equiv alent among all components that are a part of the compartment. Oversight and inspection of these management practices must be conducted by the company’s licensed, accredited veteri narians. (ii) Veterinary staff from the Official State Agency and NPIP staff will work in partnership with licensed, accred ited veterinarians to train and certify auditors through Service-approved workshops. The trained auditors will conduct biosecurity and operational audits at least once every 2 years to ensure the integrity of the compart ment. These audits will include evalua tion of the critical control points and standard operating practices within the compartment, verification of the health status of the flock(s) contained within the compartment, and examina tion of the biosecurity and manage ment system of the integrated compo nents of the compartment. (iii) In addition, the company must demonstrate compliance with para graph (a)(1) of this section for remain ing in the U.S. Avian Influenza Clean classification, surveillance for NAI within the compartment, and con ducting tests in State or Federal lab oratories or in NPIP authorized labora tories. Accredited veterinarians are re sponsible for the enforcement of active and passive surveillance of NAI in pri mary breeder flocks. Baseline health status must be maintained for all flocks or subpopulations within the compartment, indicating the dates and negative results of all avian influenza surveillance and monitoring testing, the dates and history of last disease oc currence (if any), the number of out breaks, and the methods of disease con trol that were applied. (iv) Documentation will be main tained in the company’s database and will be verified as required by the Serv ice and/or the Official State Agency. VerDate Sep<11>2014 13:56 Feb 14, 2018 Jkt 244028 PO 00000 Frm 00954 Fmt 8010 Sfmt 8010 Q:\09\9V1.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 945 Animal and Plant Health Inspection Service, USDA § 145.92 (3) Service and Official State Agency activities for maintenance of the compart ment. The Service will work in coopera tion with the Official State Agencies to ensure the continued integrity of any recognized compartments. Activities include: (i) Oversight of the establishment and management of compartments; (ii) Establishment of effective part nerships between the Service, the Plan, and the primary breeder industry; (iii) Approval or denial of classifica tion of compartments as U.S. Avian In fluenza Clean Compartments under paragraph (a)(1) of this section; (iv) Official certification of the health status of the compartment, and commodities that may be traded from it through participation in the Plan for avian diseases, including the U.S. Avian Influenza Clean program as de scribed in § 145.83(g) and diagnostic sur veillance for H5/H7 low pathogenicity AI as described in § 145.15; (v) Conducting audits of compart ments at least once every 2 years to: (A) Confirm that the primary breed ing company’s establishments are epidemiologically distinct and path ways for the introduction of disease into the compartment are closed through routine operational proce dures; and (B) Evaluate and assess the manage ment and husbandry practices relating to biosecurity to determine whether they are in compliance with hygiene and biosecurity procedures for poultry primary breeding flocks and hatcheries in accordance with part 147 of this sub chapter; (vi) Providing, upon request, model plans for management and husbandry practices relating to biosecurity in ac cordance with part 147 of this sub chapter, risk evaluations in conjunc tion with the primary breeder industry (including disease surveillance such as VS Form 9–4, ‘‘Summary of Breeding Flock Participation’’), and diagnostic capability summaries and systems for initial State response and containment plans in accordance with § 56.10 of this chapter; and (vii) Publicizing and sharing com partment information with inter national trading partners, upon re quest, to establish approval and rec ognition of the compartment, including timeliness and accuracy of disease re porting and surveillance measures as described in §§ 145.15 and 145.83(g). (4) Emergency response and notifica tion. In the case of a confirmed positive of NAI in the subpopulation of the compartment, the management of the compartment must notify the Service. The Service will immediately suspend the status of the compartment. A com partment would be eligible to resume trade with importing countries only after the compartment has adopted the necessary measures to reestablish the biosecurity level and confirm that NAI is not present in the compartment and the Service has reevaluated the man agement and biosecurity measures of the compartment and approved said compartment for trade. (b) [Reserved] [79 FR 38763, July 9, 2014] Subpart I—Special Provisions for Meat-Type Waterfowl Breed ing Flocks and Products SOURCE: 76 FR 15794, Mar. 22, 2011, unless otherwise noted. § 145.91 Definitions. Except where the context otherwise requires, for the purposes of this sub part the following term shall be con strued to mean: Meat-type waterfowl breeding flocks. Flocks of domesticated duck or goose that are composed of stock that has been developed and is maintained for the primary purpose of producing baby poultry that will be raised under con finement for the primary purpose of producing meat for human consump tion. § 145.92 Participation. Participating flocks of meat-type wa terfowl and the eggs and baby poultry produced from them shall comply with the applicable general provisions of subpart A of this part and the special provisions of this subpart I. (a) Started poultry shall lose their identity under Plan terminology when not maintained by Plan participants under the conditions prescribed in § 145.5(a). VerDate Sep<11>2014 13:56 Feb 14, 2018 Jkt 244028 PO 00000 Frm 00955 Fmt 8010 Sfmt 8010 Q:\09\9V1.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 946 9 CFR Ch. I (1–1–18 Edition) § 145.93 (b) Hatching eggs produced by pri mary and multiplier breeding flocks should be nest clean. They may be fu migated in accordance with part 147 of this subchapter or otherwise sanitized. (c) Any nutritive material provided to baby poultry must be free of the avian pathogens that are officially rep resented in the Plan disease classifica tions listed in § 145.10. [76 FR 15794, Mar. 22, 2011, as amended at 79 FR 38764, July 9, 2014; 81 FR 53250, Aug. 12, 2016] § 145.93 Terminology and classifica tion; flocks and products. Participating flocks, and the eggs and baby poultry produced from them, that have met the respective require ments 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 para graphs (b)(1) through (b)(5) of this sec tion (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 reac tors. (2) It is a multiplier breeding flock, or a breeding flock composed of prog eny of a primary breeding flock which is intended solely for the production of multiplier breeding flocks, and meets the following specifications as deter mined 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 Offi cial 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. Pul lorum-Typhoid Clean breeding flocks or from flocks that met equivalent re quirements under official supervision; and (iii) The flock is located on a prem ises where a flock not classified as U.S. Pullorum-Typhoid Clean was located the previous year; Provided, that an Authorized Testing Agent must blood test up to 300 birds per flock, as de scribed 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 per formed 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 qualifica tion is being sought and infected wild birds, contaminated feed or waste, or birds, equipment, supplies, or personnel from flocks infected with pullorum-ty phoid. (3) It is a multiplier breeding flock that originated from U.S. Pullorum Typhoid Clean breeding flocks or from flocks that met equivalent require ments 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 Hatch eries’’ or have met equivalent require ments for pullorum-typhoid control under official supervision; (ii) All hatchery supply flocks within the State are qualified as U.S. Pul lorum-Typhoid Clean or have met equivalent requirements for pullorum typhoid control under official super vision: Provided, That if other domes ticated fowl 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 prohib ited; (iv) All persons performing poultry disease diagnostic services within the State are required to report to the Offi cial 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 out break involving a disease covered under the Plan are promptly followed VerDate Sep<11>2014 13:56 Feb 14, 2018 Jkt 244028 PO 00000 Frm 00956 Fmt 8010 Sfmt 8010 Q:\09\9V1.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 947 Animal and Plant Health Inspection Service, USDA § 145.93 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 Im provement Plan will conduct an inves tigation; (vi) All flocks found to be infected with pullorum or typhoid are quar antined 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 dem onstrate pullorum or typhoid infection; (vii) All poultry, including exhi bition, exotic, and game birds, but ex cluding waterfowl, going to public ex hibition shall come from U.S. Pul lorum-Typhoid Clean or equivalent flocks, or have had a negative pul lorum-typhoid test within 90 days of going to public exhibition; (viii) Discontinuation of any of the conditions or procedures described in paragraphs (a)(3)(i), (ii), (iii), (iv), (v), (vi), and (vii) of this section, or the oc currence of repeated outbreaks of pul lorum 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 in vestigation has been made by the Serv ice 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 de termined by the Service to be in com pliance with the provisions of para graph (a)(3) of this section, and in which pullorum disease or fowl typhoid is not known to exist nor to have ex isted in hatchery supply flocks within the State during the preceding 24 months. (5) It is a primary breeding flock lo cated in a State determined to be in compliance with the provisions of para graph (a)(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: Pro vided, That when a flock is a primary 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 isola tion of pullorum or typhoid has been made that can be traced to a source in that State, a bacteriological examina tion monitoring program or a sero logical examination monitoring pro gram acceptable to the Official State Agency and approved by the Service may be used in lieu of annual blood testing. (c) U.S. H5/H7 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 the H5/H7 subtypes of avian influenza. It is in tended to determine the presence of the H5/H7 subtypes of avian influenza in meat-type waterfowl breeding flocks through routine surveillance of each participating breeding flock. A flock, and the hatching eggs and baby poultry produced from it, will qualify for this classification when the Official State Agency determines that it has met one of the following requirements: (1) It is a primary breeding flock in which a minimum of 30 birds have been tested negative to the H5/H7 subtypes of avian influenza as provided in § 145.14(d) when more than 4 months of age. To retain this classification: (i) A sample of at least 30 birds must be tested and found to be negative at intervals of 90 days; or (ii) A sample of fewer than 30 birds may be tested, and found to be nega tive, at any one time if all pens are equally represented and a total of 30 birds are tested within each 90-day pe riod. (2) It is a multiplier breeding flock in which a minimum of 30 birds have been tested negative to the H5/H7 subtypes of avian influenza as provided in § 145.14(d) when more than 4 months of age. To retain this classification: (i) A sample of at least 30 birds must be tested negative at intervals of 180 days; or (ii) A sample of fewer than 30 birds may be tested, and found to be nega tive, at any one time if all pens are VerDate Sep<11>2014 13:56 Feb 14, 2018 Jkt 244028 PO 00000 Frm 00957 Fmt 8010 Sfmt 8010 Q:\09\9V1.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 948 9 CFR Ch. I (1–1–18 Edition) § 145.94 equally represented and a total of 30 birds are tested within each 180-day pe riod. (3) A sample of at least 11 birds must be tested and found negative to H5/H7 avian influenza within 21 days prior to movement to slaughter. (d) U.S. Salmonella Monitored. This program is intended to be the basis from which the breeding-hatching in dustry may conduct a program for the prevention and control of salmonel losis. It is intended to reduce the inci dence of Salmonella organisms in hatch ing eggs and day-old waterfowl through an effective and practical sanitation program at the breeder farm and in the hatchery. This will afford other seg ments of the poultry industry an op portunity to reduce the incidence of Salmonella in their products. (1) A flock and the hatching eggs and day-old waterfowl produced from it must meet the following requirements, as determined by the Official State Agency, to be eligible for this classi fication: (i) The flock is maintained in compli ance with isolation, sanitation, and management procedures for Sal monella in accordance with part 147 of this subchapter. (ii) If feed contains animal protein, the protein products must have been heated throughout to a minimum tem perature of 190 °F or above, or to a min imum temperature of 165 °F for at least 20 minutes, or to a minimum tempera ture of 184 °F under 70 lbs. pressure dur ing the manufacturing process. (iii) Feed shall be stored and trans ported in a manner that prevents con tamination. (iv) Waterfowl shall be hatched in a hatchery whose sanitation is main tained in accordance with part 147 of this subchapter and sanitized or fumi gated in accordance with part 147 of this subchapter. (v) An Authorized Agent shall take environmental samples from the hatch ery every 30 days, i.e., meconium or box liner paper. An authorized labora tory for Salmonella shall examine the samples bacteriologically. (vi) An Authorized Agent shall take environmental samples in accordance with part 147 of this subchapter from each flock at 4 months of age and every 30 days thereafter. An authorized lab oratory for Salmonella shall examine the environmental samples bacterio logically. (vii) Flocks may be vaccinated with a paratyphoid vaccine: Provided, that a sample of at least 100 birds will be seg regated and shall remain unvaccinated until the flock reaches at least 4 months of age. (2) The Official State Agency may monitor the effectiveness of the egg sanitation practices in accordance with part 147 of this subchapter. (3) To claim products are of this clas sification, all products shall be derived from a hatchery and flock that meet the requirements of the classification. (4) This classification may be re voked by the Official State Agency if the participant fails to follow rec ommended corrective measures. [76 FR 15794, Mar. 22, 2011, as amended at 79 FR 38764, July 9, 2014; 81 FR 53250, Aug. 12, 2016] § 145.94 Terminology and classifica tion; States. (a) U.S. Pullorum-Typhoid Clean State. (1) A State will be declared a U.S. Pul lorum-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), 145.53(b)(3)(i) through (vii), 145.73(b)(2)(i), 145.83(b)(2)(i), and 145.93(b)(3)(i) through (vii). (ii) No pullorum disease or fowl ty phoid is known to exist nor to have ex isted in hatchery supply flocks within the State during the preceding 12 months: Provided, That pullorum dis ease or fowl typhoid found within the preceding 24 months in waterfowl, exhi bition poultry, and game bird breeding flocks will not prevent a State that is otherwise eligible from qualifying. (2) Discontinuation of any of the con ditions described in paragraph (a)(1)(i) of this section, or repeated outbreaks of pullorum or typhoid occur in hatch ery supply flocks described in para graph (a)(1)(ii) of this section, or if an infection spreads from the originating premises, the Service shall have grounds to revoke its determination VerDate Sep<11>2014 13:56 Feb 14, 2018 Jkt 244028 PO 00000 Frm 00958 Fmt 8010 Sfmt 8010 Q:\09\9V1.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 949 Animal and Plant Health Inspection Service, USDA § 146.1 that the State is entitled to this classi fication. 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 accord ance with rules of practice adopted by the Administrator. (b) [Reserved] PART 146—NATIONAL POULTRY IM PROVEMENT PLAN FOR COM MERCIAL POULTRY Subpart A—General Provisions Sec. 146.1 Definitions. 146.2 Administration. 146.3 Participation. 146.4 General provisions for all partici pating flocks and slaughter plants. 146.5 Specific provisions for all partici pating flocks. 146.6 Specific provisions for participating slaughter plants. 146.7 Terminology and classification; gen eral. 146.8 Terminology and classification; slaughter plants. 146.9 Terminology and classification; flocks, products, and States. 146.10 Supervision. 146.11 Inspections. 146.12 Debarment from participation. 146.13 Testing. 146.14 Diagnostic surveillance program for H5/H7 low pathogenic avian influenza. Subpart B—Special Provisions for Commercial Table-Egg Layer Flocks 146.21 Definitions. 146.22 Participation. 146.23 Terminology and classification; flocks and products. 146.24 Terminology and classification; States. Subpart C—Special Provisions for Meat Type Chicken Slaughter Plants 146.31 Definitions. 146.32 Participation. 146.33 Terminology and classification; meat-type chicken slaughter plants. Subpart D—Special Provisions for Meat Type Turkey Slaughter Plants 146.41 Definitions. 146.42 Participation. 146.43 Terminology and classification; meat-type turkey slaughter plants. 146.44 Terminology and classification; States. Subpart E—Special Provisions for Commer cial Upland Game Birds, Commercial Waterfowl, Raised-for-Release Upland Game Birds, and Raised-for-Release Waterfowl 146.51 Definitions. 146.52 Participation. 146.53 Terminology and classification; slaughter plants and premises. AUTHORITY: 7 U.S.C. 8301–8317; 7 CFR 2.22, 2.80, and 371.4. SOURCE: 71 FR 56328, Sept. 26, 2006, unless otherwise noted. Subpart A—General Provisions § 146.1 Definitions. Except where the context otherwise requires, for the purposes of this sub part the following terms shall be con strued, respectively, to mean: Administrator. The Administrator, Animal and Plant Health Inspection Service, or any person authorized to act for the Administrator. Affiliated flock. A meat-type flock that is owned by or has an agreement to participate in the Plan with a slaughter plant and that participates in the Plan through that slaughter plant. Animal and Plant Health Inspection Service (APHIS). The Animal and Plant Health Inspection Service of the U.S. Department of Agriculture. Authorized Agent. Any person des ignated under § 146.10(a) to perform functions under this part. Authorized laboratory. An authorized laboratory is a laboratory that meets the requirements of § 147.52 and is thus qualified to perform the assays in ac cordance with part 147 of this sub chapter. Classification. A designation earned by participation in a Plan program. Commercial meat-type flock. All of the meat-type chickens, spent fowl, meat type turkeys, commercial upland game birds, or commercial waterfowl on one farm. However, at the discretion of the Official State Agency, any group of poultry which is segregated from an other group in a manner sufficient to prevent the transmission of H5/H7 LPAI and has been so segregated for a VerDate Sep<11>2014 13:56 Feb 14, 2018 Jkt 244028 PO 00000 Frm 00959 Fmt 8010 Sfmt 8010 Q:\09\9V1.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 950 9 CFR Ch. I (1–1–18 Edition) § 146.1 period of at least 21 days may be con sidered as a separate flock. Commercial table-egg layer flock. All table-egg layers of common age or pul let source on one premises. Commercial table-egg layer premises. A farm containing contiguous flocks of commercial table-egg layers under common ownership. Commercial table-egg layer pullet flock. A table-egg layer flock prior to the onset of egg production. Cooperating State Agency. Any State authority recognized by the Depart ment to cooperate in the administra tion of the provisions of part 56 of this chapter. This may include the State animal health authority or the Official State Agency. Department. The U.S. Department of Agriculture. Domesticated. Propagated and main tained under the control of a person. Equivalent. Requirements which are equal to or exceed the program, condi tions, criteria, or classifications with which they are compared, as deter mined by the Official State Agency and with the concurrence of the Service. H5/H7 low pathogenic avian influenza (LPAI). An infection of poultry caused by an influenza A virus of H5 or H7 subtype that has an intravenous patho genicity index in 6-week-old chickens less than or equal to 1.2 or causes less than 75 percent mortality in 4- to 8 week-old chickens infected intra venously, or an infection with influ enza A viruses of H5 or H7 subtype with a cleavage site that is not consistent with a previously identified highly pathogenic avian influenza virus. H5/H7 LPAI virus infection (infected). (1) Poultry will be considered to be in fected with H5/H7 LPAI for the pur poses of this part if: (i) H5/H7 LPAI virus has been iso lated and identified as such from poul try; or (ii) Viral antigen or viral RNA spe cific to the H5 or H7 subtype of AI virus has been detected in poultry; or (iii) Antibodies to the H5 or H7 subtype of the AI virus that are not a consequence of vaccination have been detected in poultry. If vaccine is used, methods should be used to distinguish vaccinated birds from birds that are both vaccinated and infected. In the case of isolated serological positive re sults, H5/H7 LPAI infection may be ruled out on the basis of a thorough ep idemiological investigation that does not demonstrate further evidence of H5/H7 LPAI infection, as determined by the Cooperating State Agency, the Of ficial State Agency, and APHIS. (2) The official determination that H5/H7 LPAI virus has been isolated and identified, viral antigen or viral RNA specific to the H5 or H7 subtype of AI virus has been detected, or antibodies to the H5 or H7 subtype of AI virus have been detected may only be made by the National Veterinary Services Laboratories. Official State Agency. The State au thority recognized by the Department to cooperate in the administration of the Plan. 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, waterfowl, and game birds, except doves and pigeons, that are bred for the primary purpose of producing eggs or meat. Program. Management, sanitation, testing, and monitoring procedures which, if complied with, will qualify, and maintain qualification for, des ignation of a flock, a slaughter plant, or a State by an official Plan classi fication and illustrative design, as de scribed in § 146.9 of this part. Service. The Animal and Plant Health Inspection Service of the U.S. Depart ment of Agriculture. State. Any of the States, the District of Columbia, the Commonwealth of Puerto Rico, Guam, the Common wealth of the Northern Mariana Is lands, the Virgin Islands of the United States, or any territory or possession of the United States. State Inspector. Any person employed or authorized under § 146.10(b) to per form functions under this part. United States. All of the States. [71 FR 56328, Sept. 26, 2006, as amended at 74 FR 14715, Apr. 1, 2009; 75 FR 10658, Mar. 9, 2010; 76 FR 15796, Mar. 22, 2011; 79 FR 38765, July 9, 2014; 81 FR 53250, Aug. 12, 2016] VerDate Sep<11>2014 13:56 Feb 14, 2018 Jkt 244028 PO 00000 Frm 00960 Fmt 8010 Sfmt 8010 Q:\09\9V1.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 951 Animal and Plant Health Inspection Service, USDA § 146.3 § 146.2 Administration. (a) The Department cooperates through a Memorandum of Under standing with the Official State Agen cy in the administration of the Plan. In the Memorandum of Understanding, the Official State Agency must des ignate a contact representative to serve as a liaison between the Service and the Official State Agency. (b) The administrative procedures and decisions of the Official State Agency are subject to review by the Service. The Official State Agency shall carry out the administration of the Plan within the State according to the applicable provisions of the Plan and the Memorandum of Under standing. (c)(1) An Official State Agency may accept for participation a commercial table-egg layer pullet flock, commer cial table-egg layer flock, or a commer cial meat-type flock (including an af filiated flock) located in another par ticipating State under a mutual under standing and agreement, in writing, be tween the two Official State Agencies regarding conditions of participation and supervision. (2) An Official State Agency may ac cept for participation a commercial table-egg layer pullet flock, commer cial table-egg layer flock, or a commer cial meat-type flock (including an af filiated flock) located in a State that does not participate in the Plan under a mutual understanding and agree ment, in writing, between the owner of the flock and the Official State Agency regarding conditions of participation and supervision. (d) The Official State Agency of any State may adopt regulations applicable to the administration of the Plan in such State further defining the provi sions of the Plan or establishing higher standards, compatible with the Plan. (e) An authorized laboratory will conduct tests in accordance with part 147 of this subchapter when deter mining the status of a participating flock with respect to an official Plan classification. (f) Cooperating State Agencies will be responsible for making the deter mination to request Federal assistance under part 56 of this chapter in the event of an outbreak of H5/H7 LPAI. [71 FR 56328, Sept. 26, 2006, as amended at 74 FR 14716, Apr. 1, 2009; 75 FR 10658, Mar. 9, 2010; 79 FR 38765, July 9, 2014; 81 FR 53250, Aug. 12, 2016] § 146.3 Participation. (a) Any commercial table-egg layer pullet flock, table-egg producer, raised for-release upland game bird premises, and raised-for-release waterfowl prem ises and any commercial upland game bird, commercial waterfowl, meat-type chicken or meat-type turkey slaughter plant, including its affiliated flocks, may participate in the Plan when the producer or plant has demonstrated, to the satisfaction of the Official State Agency, that its facilities, personnel, and practices are adequate for carrying out the relevant special provisions of this part and has signed an agreement with the Official State Agency to com ply with the relevant special provisions of this part. (b) Each participant shall comply with the Plan throughout the oper ating year, or until released by the Of ficial State Agency. (c) A participating slaughter plant shall participate with all of the com mercial upland game bird, commercial waterfowl, meat-type chicken, spent fowl, and/or meat-type turkey flocks that are processed at the facility, in cluding affiliated flocks. Affiliated flocks must participate through a writ ten agreement with a participating slaughter plant that is approved by the Official State Agency. (d) Participation in the Plan shall en title the participant to use the Plan emblem reproduced as follows: VerDate Sep<11>2014 13:56 Feb 14, 2018 Jkt 244028 PO 00000 Frm 00961 Fmt 8010 Sfmt 8010 Q:\09\9V1.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 952 9 CFR Ch. I (1–1–18 Edition) § 146.4 [71 FR 56328, Sept. 26, 2006, as amended at 74 FR 14716, Apr. 1, 2009; 79 FR 38765, July 9, 2014; 81 FR 53250, Aug. 12, 2016] § 146.4 General provisions for all par ticipating flocks and slaughter plants. (a) Records that establish the iden tity of products handled shall be main tained in a manner satisfactory to the Official State Agency. (b) Material that is 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 Agen cy and the Federal Trade Commission. A participant advertising products as being of any official classification may include in their advertising reference to associated or franchised slaughter or production facilities only when such fa cilities produce products of the same classification. (d) 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 partici pant and may be used on each certifi cate, invoice, shipping label, or other document used by the participant in the sale of the participant’s products. Each Official State Agency which re quires an approval number for out-of State participants to ship into its State shall honor this number. (Approved by the Office of Management and Budget under control number 0579–0007) [71 FR 56328, Sept. 26, 2006, as amended at 75 FR 10658, Mar. 9, 2010] § 146.5 Specific provisions for all par ticipating flocks. (a) Participating flocks, and all equipment used in connection with the flocks, shall be separated from non participating flocks in a manner ac ceptable to the Official State Agency. (b) Poultry equipment, and poultry houses and the land in the immediate vicinity thereof, shall be kept in sani tary condition in accordance with part 147 of this subchapter. [71 FR 56328, Sept. 26, 2006, as amended at 79 FR 38765, July 9, 2014] § 146.6 Specific provisions for partici pating slaughter plants. (a) Only commercial upland game bird, commercial waterfowl, meat-type chicken, and meat-type turkey slaugh ter plants that are under continuous inspection by the Food Safety and In spection Service of the Department or under State inspection that the Food Safety and Inspection Service has rec ognized as equivalent to Federal in spection may participate in the Plan. (b) To participate in the Plan, meat type chicken, meat-type turkey, and commercial upland game bird and com mercial waterfowl slaughter plants must follow the relevant special provi sions in §§ 146.33(a), 146.43(a), and 146.53(a), respectively, for sample col lection and flock monitoring, unless they are exempted from the special provisions under §§ 146.32(b), 146.42(b), or 146.52(b), respectively. [74 FR 14716, Apr. 1, 2009] § 146.7 Terminology and classification; general. The official classification terms de fined in §§ 146.8 and 146.9 and the var ious designs illustrative of the official classifications reproduced in § 146.9 may be used only by participants and to describe products that have met all VerDate Sep<11>2014 13:56 Feb 14, 2018 Jkt 244028 PO 00000 Frm 00962 Fmt 8010 Sfmt 8010 Q:\09\9V1.TXT 31 ER 2 6 S E 0 6 .0 0 0 < /G P H > kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 953 Animal and Plant Health Inspection Service, USDA § 146.10 of the specific requirements of such classifications. § 146.8 Terminology and classification; slaughter plants. Participating slaughter plants shall be designated as ‘‘U.S. H5/H7 Avian In fluenza Monitored.’’ All Official State Agencies shall be notified by the Serv ice of additions, withdrawals, and changes in classification. § 146.9 Terminology and classification; flocks, products, and States. Participating flocks, products pro duced from them, and States that have met the requirements of a classifica tion in this part may be designated by the corresponding illustrative design in this section. (a) U.S. H5/H7 Avian Influenza Mon itored. (See §§ 146.23(a), 146.33(a), 146.43(a), and 146.53(a) and (b).) (b) U.S. H5/H7 Avian Influenza Mon itored State, Layers. (See § 146.24.) (c) U.S. H5/H7 Avian Influenza Mon itored State, Turkeys. (See § 146.44.) [71 FR 56328, Sept. 26, 2006, as amended at 74 FR 14716, Apr. 1, 2009; 76 FR 15796, Mar. 22, 2011] § 146.10 Supervision. (a) The Official State Agency may designate qualified persons as Author ized Agents to do the sample collecting provided for in § 146.13 of this part. (b) The Official State Agency shall employ or authorize qualified persons as State Inspectors to perform the se lecting and testing of participating flocks and to perform the official in spections necessary to verify compli ance with the requirements of the Plan. VerDate Sep<11>2014 13:56 Feb 14, 2018 Jkt 244028 PO 00000 Frm 00963 Fmt 8010 Sfmt 8010 Q:\09\9V1.TXT 31 ER 2 6 S E 0 6 .0 0 1 < /G P H > E R 2 6 S E 0 6 .0 0 2 < /G P H > E R 2 6 S E 0 6 .0 0 3 < /G P H > kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 954 9 CFR Ch. I (1–1–18 Edition) § 146.11 (c) Authorities issued to Authorized Agents or State Inspectors under the provisions of this section shall be sub ject to cancellation by the Official State Agency on the grounds of incom petence or failure to comply with the provisions of the Plan or regulations of the Official State Agency. Such actions shall not be taken until thorough in vestigation has been made by the Offi cial State Agency and the authorized person has been given notice of the pro posed action and the basis thereof and an opportunity to present his or her views. § 146.11 Inspections. (a) Each participating slaughter plant shall be audited at least once an nually or a sufficient number of times each year to satisfy the Official State Agency that the participating slaugh ter plant is in compliance with the pro visions of this part. The yearly audit will consist of an evaluation of 2 weeks’ worth of records, selected at random, of the following data: (1) The actual flock slaughter date for each flock. This information must come from a verifiable source. Verifiable sources include electronic record systems that have oversight from the Department’s Grain Inspec tors, Packers and Stockyards Adminis tration or Food Safety and Inspection Service (FSIS) documents such as FSIS Form 9061–2. (2) Laboratory test results for each flock slaughtered with the sample col lection date and test result. The test must be NPIP-approved and performed in an authorized laboratory of the NPIP. (b) A flock will be considered to be conforming to protocol if it meets the requirements as described in § 146.33(a), § 146.43(a), or § 146.53(a). (c) Two or more flocks that are found to be not conforming to protocol in the yearly audit for a slaughter plant shall be cause for a deficiency rating for that plant. However, if the root cause for the deficiency was identified, cor rected, and documented, the plant will be eligible for an immediate reevalua tion of 2 additional weeks’ worth of records, again selected at random. If no more than one missed flock is identi fied in this reevaluation, the plant will be considered in compliance and no fur ther action will be required. Plants found to be deficient must provide a written corrective action plan to the auditor within 2 weeks of receipt of the deficiency rating. A followup audit on the information in paragraphs (a)(1) and (a)(2) of this section will occur within 90 days from the receipt of the corrective action plan. Slaughter plants will retain their classification and may continue to use the Plan em blem in § 146.9(a) during this process. A failure on the followup audit may re sult in disbarment from participation according to the procedures in § 146.12. (d) On-site inspections of any partici pating flocks and premises will be con ducted if a State Inspector determines that a breach of testing has occurred for the Plan programs for which the flocks are certified. (e) The official H5/H7 LPAI testing records of all participating flocks and slaughter plants shall be examined an nually by a State Inspector. Official H5/H7 LPAI testing records shall be maintained for 3 years. (Approved by the Office of Management and Budget under control number 0579–0007) [71 FR 56328, Sept. 26, 2006, as amended at 74 FR 14716, Apr. 1, 2009; 75 FR 10658, Mar. 9, 2010; 81 FR 53250, Aug. 12, 2016] § 146.12 Debarment from participation. Participants in the Plan who, after investigation by the Official State Agency or its representative, are noti fied in writing of their apparent non compliance with the Plan provisions or regulations of the Official State Agen cy shall be afforded a reasonable time, as specified by the Official State Agen cy, 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 Offi cial State Agency may deem appro priate. The debarred participant shall be afforded notice of the bases for the debarment and opportunity to present his or her views with respect to the de barment in accordance with procedures adopted by the Official State Agency. The Official State Agency shall there upon decide whether the debarment VerDate Sep<11>2014 13:56 Feb 14, 2018 Jkt 244028 PO 00000 Frm 00964 Fmt 8010 Sfmt 8010 Q:\09\9V1.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 955 Animal and Plant Health Inspection Service, USDA § 146.13 order shall continue in effect. Such de cision shall be final unless the debarred participant, within 30 days after the issuance of the debarment order, re quests the Administrator to determine the eligibility of the debarred partici pant for participation in the Plan. In such an event, the Administrator shall determine the matter de novo in ac cordance 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 fol lowing definitions shall apply with re spect to terms used in such rules of practice: (a) Administrator means the Adminis trator, Animal and Plant Health In spection Service of the U.S. Depart ment of Agriculture, or any officer or employee to whom authority has here tofore been delegated or to who author ity may hereafter be delegated to act in his or her stead. (b) [Reserved] § 146.13 Testing. (a) Samples. Either egg or blood sam ples may be used for testing. Samples must be collected in accordance with the following requirements: (1) Egg samples. Egg samples must be collected and prepared in accordance with part 147 of this subchapter. (2) Blood samples. Blood samples ob tained in the slaughter plant should be collected after the kill cut with birds remaining on the kill line. Hold an open 1.5 mL snap cap micro-centrifuge tube under the neck of the bird directly after the kill cut and collect drips of blood until the tube is half full. Keep the blood tubes at room temperature for the clot to form, which should re quire a minimum of 4 hours and a max imum of 12 hours. Refrigerate the tube after the clot has formed. Put tubes in a container and label it with plant name, date, shift (A.M. or Day, P.M. or Night), and flock number. After the clot is formed, the clot should be re moved by the Authorized Agent in order to ensure good-quality sera. Pre pare a laboratory submission form and ship samples with submission forms to the laboratory in a polystyrene foam cooler with frozen ice packs. Submis sion forms and the manner of submis sion must be approved by the Official State Agency and the authorized lab oratory to ensure that there is suffi cient information to identify the sam ples and that the samples are received in an acceptable condition for further tests to be reliably performed. Blood samples should be shipped routinely to the laboratory. Special arrangements should be developed for samples held over the weekend to ensure that the samples can be reliably tested. Blood samples for official tests shall be drawn by an Authorized Agent or State Inspector. (b) Avian influenza. The official tests for avian influenza are described in paragraphs (b)(1) and (b)(2) of this sec tion: (1) Antibody detection tests—(i) En zyme-linked immunosorbent assay (ELISA). ELISA must be conducted using test kits approved by the Depart ment and the Official State Agency and must be conducted in accordance with the recommendations of the producer or manufacturer. (ii) The agar gel immunodiffusion (AGID) test. (A) The AGID test must be conducted on all ELISA-positive sam ples. (B) The AGID test must be conducted using reagents approved by the Depart ment and the Official State Agency. (C) The AGID test for avian influenza must be conducted in accordance with part 147 of this subchapter. The test can be conducted on egg yolk or blood samples. The AGID test is not rec ommended for use in waterfowl. (D) Positive tests for the AGID must be further tested by Federal Reference Laboratories using appropriate tests for confirmation. Final judgment may be based upon further sampling and ap propriate tests for confirmation. (2) Agent detection tests. Agent detec tion tests may be used to detect influ enza A matrix gene or protein but not to determine hemagglutinin or neuraminidase subtypes. Samples for this testing should be collected from naturally occurring flock mortality or clinically ill birds. (i) The real time reverse transcriptase/ polymerase chain reaction (RRT–PCR) assay. (A) The RRT–PCR tests must be conducted using reagents approved by the Department and the Official State VerDate Sep<11>2014 13:56 Feb 14, 2018 Jkt 244028 PO 00000 Frm 00965 Fmt 8010 Sfmt 8010 Q:\09\9V1.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 956 9 CFR Ch. I (1–1–18 Edition) § 146.14 Agency. The RRT–PCR must be con ducted using the National Veterinary Services Laboratories (NVSL) official protocol for RRT–PCR and must be conducted by personnel who have passed an NVSL proficiency test. (B) Positive results from the RRT– PCR must be further tested by Federal Reference Laboratories using appro priate tests for confirmation. Final judgment may be based upon further sampling and appropriate tests for con firmation. (ii) USDA-licensed type A influenza antigen capture immunoassay (ACIA). (A) The USDA-licensed type A influenza ACIA must be conducted using test kits approved by the Department and the Official State Agency and must be conducted in accordance with the rec ommendations of the producer or man ufacturer. (B) Chicken and turkey flocks that test positive on the ACIA must be re tested using the RRT–PCR or virus iso lation. Positive results from the RRT– PCR or virus isolation must be further tested by Federal Reference Labora tories using appropriate tests for con firmation. Final judgment may be based upon further sampling and appro priate tests for confirmation. (3) The official determination of a flock as positive for the H5 or H7 subtypes avian influenza may be made only by NVSL. (Approved by the Office of Management and Budget under control number 0579–0007) [71 FR 56328, Sept. 26, 2006, as amended at 74 FR 14716, Apr. 1, 2009; 75 FR 10658, Mar. 9, 2010; 79 FR 38765, July 9, 2014] § 146.14 Diagnostic surveillance pro gram for H5/H7 low pathogenic avian influenza. (a) The Official State Agency must develop a diagnostic surveillance pro gram for H5/H7 low pathogenic avian influenza for all poultry in the State. The exact provisions of the program are at the discretion of the States. The Service will use the standards in para graph (b) of this section in assessing in dividual State plans for adequacy, in cluding the specific provisions that the State developed. The standards should be used by States in developing those plans. (b) Avian influenza must be a disease reportable to the responsible State au thority (State veterinarian, etc.) by all licensed veterinarians. To accomplish this, all laboratories (private, State, and university laboratories) that per form diagnostic procedures on poultry must examine all submitted cases of unexplained respiratory disease, egg production drops, and mortality for avian influenza by both an approved se rological test and an approved antigen detection test. Memoranda of under standing or other means must be used to establish testing and reporting cri teria (including criteria that provide for reporting H5 and H7 low pathogenic avian influenza directly to the Service) and approved testing methods. In addi tion, States should conduct outreach to poultry producers, especially owners of smaller flocks, regarding the impor tance of prompt reporting of clinical symptoms consistent with avian influ enza. (Approved by the Office of Management and Budget under control number 0579–0007) [71 FR 56328, Sept. 26, 2006, as amended at 75 FR 10658, Mar. 9, 2010] Subpart B—Special Provisions for Commercial Table-Egg Layer Flocks § 146.21 Definitions. Table-egg layer. A domesticated chicken grown for the primary purpose of producing eggs for human consump tion. Table-egg layer pullet. A sexually im mature domesticated chicken grown for the primary purpose of producing eggs for human consumption. [71 FR 56328, Sept. 26, 2006, as amended at 76 FR 15796, Mar. 22, 2011] § 146.22 Participation. (a) Participating commercial table egg layer flocks shall comply with the applicable general provisions of sub part A of this part and the special pro visions of subpart B of this part. (b) Commercial table-egg laying premises with fewer than 75,000 birds are exempt from the special provisions of subpart B of this part. VerDate Sep<11>2014 13:56 Feb 14, 2018 Jkt 244028 PO 00000 Frm 00966 Fmt 8010 Sfmt 8010 Q:\09\9V1.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 957 Animal and Plant Health Inspection Service, USDA § 146.24 § 146.23 Terminology and classifica tion; flocks and products. Participating flocks which have met the respective requirements specified in this section may be designated by the following terms and the cor responding designs illustrated in § 146.9 of this part: (a) U.S. H5/H7 Avian Influenza Mon itored—(1) Table-egg layer pullet flocks. This program is intended to be the basis from which the table-egg layer industry may conduct a program to monitor for the H5/H7 subtypes of avian influenza. It is intended to deter mine the presence of the H5/H7 subtypes of avian influenza in table-egg layer pullets through routine surveil lance of each participating commercial table-egg layer pullet flock. A flock will qualify for this classification when the Official State Agency determines that it has met one of the following re quirements: (i) It is a commercial table-egg layer pullet flock in which a minimum of 11 birds have been tested negative to the H5/H7 subtypes of avian influenza as provided in § 146.13(b) within 30 days prior to movement; or (ii) It is a commercial table-egg layer pullet flock that has an ongoing active and diagnostic surveillance program for the H5/H7 subtypes of avian influ enza in which the number of birds test ed is equivalent to the number required in paragraph (a)(1)(i) of this section and that is approved by the Official State Agency and the Service. (2) Table-egg layer flocks. This pro gram is intended to be the basis from which the table-egg layer industry may conduct a program to monitor for the H5/H7 subtypes of avian influenza. It is intended to determine the presence of the H5/H7 subtypes of avian influenza in table-egg layer through routine sur veillance of each participating com mercial table-egg layer flock. A flock will qualify for this classification when the Official State Agency determines that it has met the following require ments: (i) It is a commercial table-egg layer flock in which a minimum of 11 birds have been tested negative to the H5/H7 subtypes of avian influenza as provided in § 146.13(b) within 30 days prior to dis posal; and either (ii) It is a commercial table-egg layer flock in which a minimum of 11 birds have been tested negative for the H5/H7 subtypes of avian influenza as provided in § 146.13(b) within a 12-month period; or (iii) It is a commercial table-egg layer flock that has an ongoing active and diagnostic surveillance program for the H5/H7 subtypes of avian influ enza in which the number of birds test ed is equivalent to the number required in paragraph (a)(2)(i) or paragraph (a)(2)(ii) of this section and that is ap proved by the Official State Agency and the Service. (b) [Reserved] [71 FR 56328, Sept. 26, 2006, as amended at 76 FR 15796, Mar. 22, 2011; 79 FR 38765, July 9, 2014; 79 FR 71624, Dec. 3, 2014] § 146.24 Terminology and classifica tion; States. (a) U.S. H5/H7 Avian Influenza Mon itored State, Layers. (1) A State will be declared a U.S. H5/H7 Avian Influenza Monitored State, Layers when it has been determined by the Service that: (i) All commercial table-egg layer flocks and all commercial table-egg layer pullet flocks that supply those flocks in production within the State that are not exempt from the special provisions of this subpart B under § 146.22 are classified as U.S. H5/H7 Avian Influenza Monitored under § 146.23(a) of this part; (ii) All egg-type chicken breeding flocks in production within the State are classified as U.S. Avian Influenza Clean under § 145.23(h) of this sub chapter; (iii) All persons performing poultry disease diagnostic services within the State are required to report to the Offi cial State Agency, within 24 hours, the source of all table-egg layer and table egg layer pullet specimens that were deemed positive on an official test for avian influenza, as designated in § 146.13(a) of this chapter; (iv) All table-egg layer and table-egg layer pullet specimens that were deemed positive on an official test for avian influenza, as designated in § 146.13(a) of this chapter, are sent to an authorized laboratory for subtyping; and VerDate Sep<11>2014 13:56 Feb 14, 2018 Jkt 244028 PO 00000 Frm 00967 Fmt 8010 Sfmt 8010 Q:\09\9V1.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 958 9 CFR Ch. I (1–1–18 Edition) § 146.31 (v) All table-egg layer and table-egg layer pullet flocks within the State that are found to be infected with the H5/H7 subtypes of avian influenza are quarantined, in accordance with an ini tial State response and containment plan as described in part 56 of this chapter and under the supervision of the Official State Agency. (2) If there is a discontinuation of any of the conditions described in para graph (a)(1) of this section, or if re peated outbreaks of the H5/H7 subtypes of avian influenza occur in commercial table-egg layer flocks as described in paragraph (a)(1)(i) of this section, or if an infection spreads from the origi nating premises, the Service shall have grounds to revoke its determination that the State is entitled to this classi fication. 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 accord ance with rules of practice adopted by the Administrator. (b) [Reserved] (Approved by the Office of Management and Budget under control number 0579–0007) [71 FR 56328, Sept. 26, 2006, as amended at 75 FR 10658, Mar. 9, 2010; 76 FR 15797, Mar. 22, 2011] Subpart C—Special Provisions for Meat-Type Chicken Slaughter Plants § 146.31 Definitions. Meat-type chicken. A domesticated chicken grown for the primary purpose of producing meat, including but not limited to broilers, roasters, fryers, and cornish. Meat-type chicken slaughter plant. A meat-type chicken slaughter plant that is federally inspected or under State inspection that the Food Safety Inspec tion Service has recognized as equiva lent to federal inspection. Shift. The working period of a group of employees who are on duty at the same time. Spent fowl. Domesticated poultry that were in production of hatching eggs or commercial table eggs and have been removed from such production. [71 FR 56328, Sept. 26, 2006, as amended at 79 FR 38766, July 9, 2014] § 146.32 Participation. (a) Participating meat-type chicken slaughter plants shall comply with ap plicable general provisions of subpart A of this part and the special provisions of this subpart C. (b) Meat-type chicken slaughter plants that slaughter fewer than 200,000 meat-type chickens in an operating week are exempt from the special pro visions of this subpart C. (c) If spent fowl are slaughtered at meat-type chicken slaughter plants that participate in the Plan, they may participate in the Plan through the provisions of this subpart C. [71 FR 56328, Sept. 26, 2006, as amended at 79 FR 38766, July 9, 2014] § 146.33 Terminology and classifica tion; meat-type chicken slaughter plants. Participating meat-type chicken slaughter plants that have met the re spective requirements specified in this section may be designated by the fol lowing terms and the corresponding de signs illustrated in § 146.9 of this part: (a) U.S. H5/H7 Avian Influenza Mon itored. This program is intended to be the basis from which the meat-type chicken industry may conduct a pro gram to monitor for the H5/H7 subtypes of avian influenza. It is intended to de termine the presence of the H5/H7 subtypes of avian influenza in meat type chickens through routine surveil lance of each participating meat-type chicken slaughter plant. A meat-type chicken slaughter plant will qualify for this classification when the Official State Agency determines that it has met one of the following requirements: (1) It is a meat-type chicken slaugh ter plant where a minimum of 11 birds per shift are tested negative for the H5/ H7 subtypes of avian influenza, as pro vided in § 146.13(b), at slaughter; Pro vided, that with the approval of the Of ficial State Agency, fewer than 11 birds per shift may be tested on any given shift if the total number of birds tested during the operating month is equiva lent to testing 11 birds per shift; or VerDate Sep<11>2014 13:56 Feb 14, 2018 Jkt 244028 PO 00000 Frm 00968 Fmt 8010 Sfmt 8010 Q:\09\9V1.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 959 Animal and Plant Health Inspection Service, USDA § 146.44 (2) It is a meat-type chicken slaugh ter plant which accepts only meat-type chickens from flocks where a minimum of 11 birds have been tested negative for antibodies to the H5/H7 subtypes of avian influenza, as provided in § 146.13(b), no more than 21 days prior to slaughter; or (3) It is a meat-type chicken slaugh ter plant that has an ongoing active and diagnostic surveillance program for the H5/H7 subtypes of avian influ enza in which the number of birds test ed is equivalent to the number required in paragraph (a)(1) or (a)(2) and that is approved by the Official State Agency and the Service. (b) [Reserved] [71 FR 56328, Sept. 26, 2006, as amended at 76 FR 15797, Mar. 22, 2011; 79 FR 38766, July 9, 2014] Subpart D—Special Provisions for Meat-Type Turkey Slaughter Plants § 146.41 Definitions. Meat-type turkey. A domesticated tur key grown for the primary purpose of producing meat. Meat-type turkey slaughter plant. A meat-type turkey slaughter plant that is federally inspected or under State inspection that the Food Safety Inspec tion Service has recognized as equiva lent to federal inspection. § 146.42 Participation. (a) Participating meat-type turkey slaughter plants shall comply with ap plicable general provisions of subpart A of this part and the special provisions of this subpart D. (b) Meat-type turkey slaughter plants that slaughter fewer than 2 mil lion meat-type turkeys in a 12-month period are exempt from the special pro visions of this subpart D. § 146.43 Terminology and classifica tion; meat-type turkey slaughter plants. Participating meat-type turkey slaughter plants which have met the respective requirements specified in this section may be designated by the following terms and the corresponding designs illustrated in § 146.9 of this part: (a) U.S. H5/H7 Avian Influenza Mon itored. This program is intended to be the basis from which the meat-type turkey industry may conduct a pro gram to monitor for the H5/H7 subtypes of avian influenza. It is intended to de termine the presence of avian influenza in meat-type turkeys through routine surveillance of each participating meat-type turkey slaughter plant. A participating meat-type turkey slaugh ter plant will qualify for this classi fication when the Official State Agen cy determines that it has met one of the following requirements: (1) It is a meat-type turkey slaughter plant that accepts only meat-type tur keys from flocks where a minimum of 6 samples per flock have been collected no more than 21 days prior to move ment to slaughter and tested negative with an approved test for type A avian influenza, as provided in § 146.13(b). It is recommended that samples be col lected from flocks over 10 weeks of age with respiratory signs such as coughing, sneezing, snicking, sinusitis, or rales; depression; or decreases in food or water intake. (2) It is a meat-type turkey slaughter plant that has an ongoing active and diagnostic surveillance program for the H5/H7 subtypes of avian influenza in which the number of birds tested is equivalent to the number required in paragraph (a)(1) and that is approved by the Official State Agency and the Service. (b) [Reserved] [71 FR 56328, Sept. 26, 2006, as amended at 74 FR 14717, Apr. 1, 2009; 76 FR 15797, Mar. 22, 2011; 79 FR 38766, July 9, 2014] § 146.44 Terminology and classifica tion; States. (a) U.S. H5/H7 Avian Influenza Mon itored State, Turkeys. (1) A State will be declared a U.S. H5/H7 Avian Influenza Monitored State, Turkeys when it has been determined by the Service that: (i) All meat-type turkey slaughter plants within the State that are not exempt from the special provisions of this subpart D under § 146.42 are classi fied as U.S. H5/H7 Avian Influenza Mon itored under § 146.43(a) of this part; (ii) All turkey breeding flocks in pro duction within the State are classified VerDate Sep<11>2014 13:56 Feb 14, 2018 Jkt 244028 PO 00000 Frm 00969 Fmt 8010 Sfmt 8010 Q:\09\9V1.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 960 9 CFR Ch. I (1–1–18 Edition) § 146.51 as U.S. H5/H7 Avian Influenza Clean under § 145.43(g) of this subchapter; (iii) All persons performing poultry disease diagnostic services within the State are required to report to the Offi cial State Agency, within 24 hours, the source of all meat-type turkey speci mens that were deemed positive on an official test for avian influenza, as des ignated in § 146.13(a) of this chapter; (iv) All meat-type turkey specimens that were deemed positive on an offi cial test for avian influenza, as des ignated in § 146.13(a) of this chapter, are sent to an authorized laboratory for subtyping; and (v) All meat-type turkey flocks with in the State that are found to be in fected with the H5/H7 subtypes of avian influenza are quarantined, in accord ance with an initial State response and containment plan as described in part 56 of this chapter, and under the super vision of the Official State Agency. (2) If there is a discontinuation of any of the conditions described in para graph (a)(1) of this section, or if re peated outbreaks of the H5/H7 subtypes of avian influenza occur in meat-type turkey flocks as described in paragraph (a)(1)(i) of this section, or if an infec tion spreads from the originating premises, the Service shall have grounds to revoke its determination that the State is entitled to this classi fication. 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 accord ance with rules of practice adopted by the Administrator. (Approved by the Office of Management and Budget under control number 0579–0007) [71 FR 56328, Sept. 26, 2006, as amended at 75 FR 10658, Mar. 9, 2010] Subpart E—Special Provisions for Commercial Upland Game Birds, Commercial Waterfowl, Raised-for-Release Upland Game Birds, and Raised-for Release Waterfowl SOURCE: 74 FR 14717, Apr. 1, 2009, unless otherwise noted. § 146.51 Definitions. Commercial upland game bird slaughter plant. A commercial upland game bird slaughter plant that is federally in spected or under State inspection that the U.S. Department of Agriculture’s Food Safety and Inspection Service has recognized as equivalent to Federal in spection. Commercial upland game birds. Upland game bird pheasants, quail, or par tridges grown under confinement for the primary purposes of producing eggs and/or meat for human consumption. Commercial waterfowl. Domesticated ducks or geese grown under confine ment for the primary purposes of pro ducing eggs and/or meat for human consumption. Commercial waterfowl slaughter plant. A commercial waterfowl slaughter plant that is federally inspected or under State inspection that the U.S. Department of Agriculture’s Food Safety and Inspection Service has rec ognized as equivalent to Federal in spection. Raised-for-release upland game birds. Pheasants, quail, and partridge that are raised under confinement for re lease in game preserves and are not breeding stock. Raised-for-release waterfowl. Water fowl that are raised under confinement for release in game preserves and are not breeding stock. Shift. The working period of a group of employees who are on duty at the same time. [74 FR 14717, Apr. 1, 2009, as amended at 81 FR 53250, Aug. 12, 2016] § 146.52 Participation. (a) Participating commercial upland game bird slaughter plants, commer cial waterfowl slaughter plants, raised for-release upland game bird premises, raised-for-release waterfowl premises, and commercial upland game bird and commercial waterfowl producing eggs for human consumption premises shall comply with the applicable general provisions of subpart A of this part and the special provisions of this subpart E. (b) Commercial waterfowl and com mercial upland game bird slaughter plants that slaughter fewer than 50,000 VerDate Sep<11>2014 13:56 Feb 14, 2018 Jkt 244028 PO 00000 Frm 00970 Fmt 8010 Sfmt 8010 Q:\09\9V1.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 961 Animal and Plant Health Inspection Service, USDA Pt. 147 birds annually are exempt from the special provisions of this subpart E. (c) Raised-for-release upland game bird premises, raised-for-release water fowl premises, and commercial upland game bird and commercial waterfowl producing eggs for human consumption premises that raise fewer than 25,000 birds annually are exempt from the special provisions of this subpart E. [74 FR 14717, Apr. 1, 2009, as amended at 81 FR 53250, Aug. 12, 2016] § 146.53 Terminology and classifica tion; slaughter plants and premises. Participating flocks which have met the respective requirements specified in this section may be designated by the following terms and the cor responding designs illustrated in § 146.9 of this part: (a) U.S. H5/H7 Avian Influenza Mon itored. This program is intended to be the basis from which the commercial waterfowl and commercial upland game bird industry may conduct a pro gram to monitor for the H5/H7 subtypes of avian influenza. It is intended to de termine the presence of the H5/H7 subtypes of avian influenza in commer cial waterfowl and commercial upland game birds through routine surveil lance of each participating slaughter plant or, in the case of egg-producing flocks, the regular surveillance of these flocks. A slaughter plant will qualify for this classification when the Official State Agency determines that it has met one of the following require ments: (1) It is a commercial upland game bird slaughter plant or commercial wa terfowl slaughter plant where a min imum of 11 birds per shift are tested negative for the H5/H7 subtypes of avian influenza, as provided in § 146.13(b), at slaughter; (2) It is a commercial upland game bird slaughter plant or commercial wa terfowl slaughter plant that only ac cepts commercial upland game birds or commercial waterfowl from flocks where a minimum of 11 birds per flock have been tested negative for the H5/H7 subtypes of avian influenza, as pro vided in § 146.13(b), no more than 21 days prior to slaughter; or (3) It is a commercial upland game bird slaughter plant or commercial wa terfowl slaughter plant that has an on going active and passive surveillance program for H5/H7 subtypes of avian in fluenza that is approved by the Official State Agency and the Service. (4) It is a commercial upland game bird or waterfowl flock that produces eggs for human consumption where a minimum of 11 birds per flock have been tested negative to the H5/H7 subtypes of avian influenza as provided in § 146.13(b) within 30 days of disposal or within a 12 month period. (5) It is a commercial upland game bird or waterfowl flock that has an on going active and passive surveillance program for H5/H7 subtypes of avian in fluenza that is approved by the Official State Agency and the Service. (b) U.S. H5/H7 Avian Influenza Mon itored. This program is intended to be the basis from which the raised-for-re lease upland game bird and raised-for release waterfowl industries may con duct a program to monitor for the H5/ H7 subtypes of avian influenza. It is in tended to determine the presence of the H5/H7 subtypes of avian influenza through routine surveillance of each participating premises. A premises will qualify for the classification when the Official State Agency determines that a representative sample of 30 birds from the participating premises has been tested with negative results for the H5/H7 subtypes of avian influenza, as provided in § 146.13(b), every 90 days. [74 FR 14717, Apr. 1, 2009, as amended at 76 FR 15797, Mar. 22, 2011; 81 FR 53250, Aug. 12, 2016] PART 147—AUXILIARY PROVISIONS ON NATIONAL POULTRY IM PROVEMENT PLAN Subpart A—Blood Testing Procedures Sec. 147.1 Blood testing procedures. 147.2–147.9 [Reserved] Subpart B—Bacteriological Examination Procedure 147.10 Bacteriological examination proce dures. 147.11–147.17 [Reserved] Subpart C—Sanitation Procedures 147.21 Sanitation procedures. VerDate Sep<11>2014 13:56 Feb 14, 2018 Jkt 244028 PO 00000 Frm 00971 Fmt 8010 Sfmt 8010 Q:\09\9V1.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 962 9 CFR Ch. I (1–1–18 Edition) § 147.1 147.22–147.27 [Reserved] Subpart D—Molecular Examination Procedures 147.30 Molecular examination procedures. 147.31 [Reserved] Subpart E—Procedure for Changing National Poultry Improvement Plan 147.41 Definitions. 147.42 General. 147.43 General Conference Committee. 147.44 Submitting, compiling, and distrib uting proposed changes. 147.45 Official delegates. 147.46 Committee consideration of proposed changes. 147.47 Conference consideration of proposed changes. 147.48 Approval of conference recommenda tions by the Department. Subpart F—Authorized Laboratories and Approved Tests and Sanitation Procedures 147.51 Definitions. 147.52 Authorized laboratories. 147.53 Approved tests and sanitation proce dures. 147.54 Approval of diagnostic test kits not licensed by the Service. AUTHORITY: 7 U.S.C. 8301–8317; 7 CFR 2.22, 2.80, and 371.4. SOURCE: 36 FR 23121, Dec. 3, 1971, unless otherwise noted. Redesignated at 44 FR 61586, Oct. 26, 1979. Subpart A—Blood Testing Procedures § 147.1 Blood testing procedures. Blood testing must be conducted in a manner approved by the Adminis trator. Approved blood testing proce dures are listed in the NPIP Program Standards, as defined in § 147.51. Blood testing procedures may also be ap proved by the Administrator in accord ance with § 147.53(d)(1). (Approved by the Office of Management and Budget under control number 0579–0007) [79 FR 38766, July 9, 2014] §§ 147.2–147.9 [Reserved] Subpart B—Bacteriological Examination Procedure § 147.10 Bacteriological examination procedures. Bacteriological examination must be conducted in a manner approved by the Administrator. Approved bacterio logical examination procedures are listed in the NPIP Program Standards, as defined in § 147.51. Bacteriological examination procedures may also be approved by the Administrator in ac cordance with § 147.53(d)(1). [79 FR 38766, July 9, 2014] §§ 147.11–147.17 [Reserved] Subpart C—Sanitation Procedures § 147.21 Sanitation procedures. Sanitation must be maintained in a manner approved by the Adminis trator. Approved procedures for main taining sanitation are listed in the NPIP Program Standards, as defined in § 147.51. Sanitation procedures may also be approved by the Administrator in accordance with § 147.53(d)(2). (Approved by the Office of Management and Budget under control number 0579–0007) [79 FR 38766, July 9, 2014; 79 FR 44263, July 31, 2014] §§ 147.22–147.27 [Reserved] Subpart D—Molecular Examination Procedures SOURCE: 72 FR 1425, Jan. 12, 2007, unless otherwise noted. § 147.30 Molecular examination proce dures. Molecular examination must be con ducted in a manner approved by the Administrator. Approved molecular ex amination procedures are listed in the NPIP Program Standards, as defined in § 147.51. Molecular examination proce dures may also be approved by the Ad ministrator in accordance with § 147.53(d)(1). [79 FR 38766, July 9, 2014] VerDate Sep<11>2014 13:56 Feb 14, 2018 Jkt 244028 PO 00000 Frm 00972 Fmt 8010 Sfmt 8010 Q:\09\9V1.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 963 Animal and Plant Health Inspection Service, USDA § 147.43 § 147.31 [Reserved] Subpart E—Procedure for Chang ing National Poultry Improve ment Plan § 147.41 Definitions. Except where the context otherwise requires, for the purposes of this sub part the following terms shall be con strued, respectively, to mean: Department. The U.S. Department of Agriculture. Egg type chickens. Chickens bred for the primary purpose of producing eggs for human consumption. Exhibition Poultry. Domesticated fowl which are bred for the combined pur poses 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. Meat type chickens. Chickens bred for the primary purpose of producing meat. NPIP Technical Committee. A com mittee made up of technical experts on poultry health, biosecurity, surveil lance, and diagnostics. The committee consists of representatives from the poultry and egg industries, univer sities, and State and Federal govern ments and is appointed by the Senior Coordinator and approved by the Gen eral Conference Committee. Plan Conference. A meeting convened for the purpose of recommending changes in the provisions of the Plan. Plan or NPIP. The National Poultry Improvement Plan. Service. The Animal and Plant Health Inspection Service, Veterinary Serv ices, of the Department. State. Any State, the District of Co lumbia, or Puerto Rico. Waterfowl. Domesticated fowl that normally swim, such as ducks and geese. [36 FR 23121, Dec. 3, 1971, as amended at 38 FR 3038, Feb. 1, 1973. Redesignated at 44 FR 61586, Oct. 26, 1979; 59 FR 12805, Mar. 18, 1994, as amended at 79 FR 38766, July 9, 2014] § 147.42 General. Changes in this subchapter shall be made in accordance with the procedure described in this subpart: Provided, That the Department reserves the right to make changes in this sub chapter without observance of such procedure when such action is deemed necessary in the public interest. § 147.43 General Conference Com mittee. (a) The General Conference Com mittee Chairperson and the Vice Chair person shall be elected by the members of the General Conference Committee. A representative of the Animal and Plant Health Inspection Service will serve as Executive Secretary and will provide the necessary staff support for the General Conference Committee. The General Conference Committee shall consist of one member-at-large who is a participant in the National Poultry Improvement Plan and one member to be elected, as provided in paragraph (b) of this section, from each of the following regions: (1) North Atlantic: Maine, New Hampshire, Vermont, Massachusetts, Rhode Island, Connecticut, New York, New Jersey, and Pennsylvania. (2) East North Central: Ohio, Indiana, Illinois, Michigan, and Wisconsin. (3) West North Central: Minnesota, Iowa, Missouri, North Dakota, South Dakota, Nebraska, and Kansas. (4) South Atlantic: Delaware, Dis trict of Columbia, Maryland, Virginia, West Virginia, North Carolina, South Carolina, Georgia, Florida, and Puerto Rico. (5) South Central: Kentucky, Ten nessee, Alabama, Mississippi, Arkan sas, Louisiana, Oklahoma, and Texas. (6) Western: Montana, Idaho, Wyo ming, Colorado, New Mexico, Arizona, Utah, Nevada, Washington, Oregon, California, Alaska, and Hawaii. (b) The regional committee members and their alternates will be elected by the official delegates of their respec tive regions, and the member-at-large will be elected by all official delegates. There must be at least two nominees for each position, the voting will be by secret ballot, and the results will be re corded. At least one nominee from each region must be from an underrep resented group (minorities, women, or persons with disabilities). The process for soliciting nominations for regional committee members will include, but VerDate Sep<11>2014 13:56 Feb 14, 2018 Jkt 244028 PO 00000 Frm 00973 Fmt 8010 Sfmt 8010 Q:\09\9V1.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 964 9 CFR Ch. I (1–1–18 Edition) § 147.44 not be limited to: Advertisements in at least two industry journals, such as the newsletters of the American Associa tion of Avian Pathologists, the Na tional Chicken Council, the United Egg Producers, and the National Turkey Federation; a FEDERAL REGISTER an nouncement; and special inquiries for nominations from universities or col leges with minority/disability enroll ments and faculty members in poultry science or veterinary science. (c) Three regional members shall be elected at each Plan Conference. All members shall serve for a period of 4 years, subject to the continuation of the Committee by the Secretary of Ag riculture, and may not succeed them selves: Provided, That an alternate member who assumed a Committee member vacancy following mid-term would be eligible for re-election to a full term. When there is a vacancy for the member-at-large position, the Gen eral Conference Committee shall make an interim appointment and the ap pointee shall serve until the next Plan Conference at which time an election will be held. If a vacancy occurs due to both a regional member and alternate being unable to serve, the vacant posi tion will be filled by an election at the earliest regularly scheduled national or regional Plan Conference, where members of the affected region have assembled. (d) The duties and functions of the General Conference Committee shall be as follows: (1) Advise and make recommenda tions to the Department on the rel ative importance of maintaining, at all times, adequate departmental funding for the NPIP to enable the Senior Coor dinator and staff to fully administer the provisions of the Plan. (2) Advise and make yearly rec ommendations to the Department with respect to the NPIP budget well in ad vance of the start of the budgetary process. (3) Assist the Department in plan ning, organizing, and conducting the biennial National Poultry Improve ment Plan Conference. (4) Consider each proposal submitted as provided in § 147.44 and make rec ommendations to subpart Committees and the Conference. Meet jointly with the NPIP Technical Committee and consider the technical aspects and ac curacy of each proposal. Recommend whether new proposals (i.e., proposals that have not been submitted as pro vided in § 147.44) should be considered by the delegates to the Plan Con ference. (5) During the interim between Plan Conferences, represent the cooperating States in: (i) Advising the Department with re spect to administrative procedures and interpretations of the Plan provisions as contained in 9 CFR. (ii) Assisting the Department in eval uating comments received from inter ested persons concerning proposed amendments to the Plan provisions. (iii) Recommending to the Secretary of Agriculture any changes in the pro visions of the Plan as may be neces sitated by unforeseen conditions when postponement until the next Plan Con ference would seriously impair the op eration of the program. Such rec ommendations shall remain in effect only until confirmed or rejected by the next Plan Conference, or until re scinded by the committee. (6) Serve as an official advisory com mittee for the study of problems relat ing to poultry health and as the need arises, to make specific recommenda tions to the Secretary of Agriculture concerning ways in which the Depart ment may assist the industry in solv ing these problems. (7) Serve as a direct liaison between the NPIP and the United States Ani mal Health Association. (8) Advise and make recommenda tions to the Department regarding NPIP involvement or representation at poultry industry functions and activi ties as deemed necessary or advisable for the purposes of the NPIP. [36 FR 23121, Dec. 3, 1971, as amended at 40 FR 1505, Jan. 8, 1975. Redesignated at 44 FR 61586, Oct. 26, 1979, and amended at 45 FR 10316, Feb. 15, 1980; 47 FR 21996, May 20, 1982; 50 FR 19900, May 13, 1985; 59 FR 12805, Mar. 18, 1994; 61 FR 11525, Mar. 21, 1996; 65 FR 8023, Feb. 17, 2000; 67 FR 8475, Feb. 25, 2002; 74 FR 14718, Apr. 1, 2009] § 147.44 Submitting, compiling, and distributing proposed changes. (a) Changes in this subchapter may be proposed by any participant, Official VerDate Sep<11>2014 13:56 Feb 14, 2018 Jkt 244028 PO 00000 Frm 00974 Fmt 8010 Sfmt 8010 Q:\09\9V1.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 965 Animal and Plant Health Inspection Service, USDA § 147.46 State Agency, the Department, or other interested person or industry or ganization. (b) Except as provided in § 147.43(d)(4), proposed changes shall be submitted in writing so as to reach the Service not later than 150 days prior to the opening date of the Plan Conference, and par ticipants in the Plan shall submit their proposed changes through their Official State Agency. (c) The name of the proponent shall be indicated on each proposed change when submitted. Each proposal should be accompanied by a brief supporting statement. (d) The Service will notify all persons on the NPIP mailing lists concerning the dates and general procedure of the conference. Hatchery and dealer par ticipants will be reminded of their privilege to submit proposed changes and to request copies of all the pub lished proposed changes. (e) The proposed changes, together with the names of the proponents and supporting statements, will be com piled by the Service and issued in proc essed form. When two or more similar changes are submitted, the Service will endeavor to unify them into one pro posal acceptable to each proponent. Copies will be distributed to officials of the Official State Agencies cooperating in the NPIP. Additional copies will be made available for meeting individual requests. [36 FR 23121, Dec. 3, 1971. Redesignated at 44 FR 61586, Oct. 26, 1979, and amended at 49 FR 19807, May 10, 1984; 79 FR 38766, July 9, 2014] § 147.45 Official delegates. Each cooperating State shall be enti tled to one official delegate for each of the programs prescribed in parts 145 and 146 of this chapter in which it has one or more participants at the time of the Conference. The official delegates shall be elected by a representative group of participating industry mem bers and be certified by the Official State Agency. It is recommended but not required that the official delegates be Plan participants. Each official del egate shall endeavor to obtain, prior to the Conference, the recommendations of industry members of his State with respect to each proposed change. [41 FR 48727, Nov. 5, 1976. Redesignated at 44 FR 61586, Oct. 26, 1979, and amended at 45 FR 10317, Feb. 15, 1980; 65 FR 8023, Feb. 17, 2000; 71 FR 56333, Sept. 26, 2006; 74 FR 14718, Apr. 1, 2009; 76 FR 15797, Mar. 22, 2011] § 147.46 Committee consideration of proposed changes. (a) The following committees shall be established to give preliminary consid eration to the proposed changes falling in their respective fields: (1) Egg-type breeding chickens. (2) Meat-type breeding chickens. (3) Breeding turkeys. (4) Breeding waterfowl, exhibition poultry, and game birds. (5) Breeding ostriches, emus, rheas, and cassowaries. (6) Egg-type commercial chickens. (7) Meat-type commercial chickens. (8) Meat-type commercial turkeys. (9) Commercial upland game birds and waterfowl and raised-for-release upland game birds and waterfowl. (b) Each official delegate shall be ap pointed a voting member in one of the committees specified in paragraph (a) of this section. (c) Since several of the proposals may be interrelated, the committees shall consider them as they may relate to others, and feel free to discuss re lated proposals with other committees. (d) The committees shall make rec ommendations to the conference as a whole concerning each proposal. The committee report shall show any pro posed change in wording and the record of the vote on each proposal, and sug gest an effective date for each proposal recommended for adoption. The indi vidual committee reports shall be sub mitted to the chairman of the con ference, who will combine them into one report showing, in numerical se quence, the committee recommenda tions on each proposal. (e) The committee meetings shall be open to any interested person. Advo cates for or against any proposal VerDate Sep<11>2014 13:56 Feb 14, 2018 Jkt 244028 PO 00000 Frm 00975 Fmt 8010 Sfmt 8010 Q:\09\9V1.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 966 9 CFR Ch. I (1–1–18 Edition) § 147.47 should feel free to appear before the ap propriate committee and present their views. [36 FR 23121, Dec. 3, 1971, as amended at 41 FR 48727, Nov. 5, 1976. Redesignated at 44 FR 61586, Oct. 26, 1979, as amended at 65 FR 8023, Feb. 17, 2000; 71 FR 56333, Sept. 26, 2006; 74 FR 14718, Apr. 1, 2009] § 147.47 Conference consideration of proposed changes. (a) The chairman of the conference shall be a representative of the Depart ment. (b) At the time designated for voting on proposed changes by the official del egates, the chairman of the General Conference Committee and the four committee chairmen shall sit at the speaker’s table and assist the chairman of the conference. (c) Each committee chairman shall present the proposals which his com mittee approves or recommends for adoption as follows: ‘‘Mr. Chairman. The committee for Egg-type chickens recommends the adoption of Proposal No. lll, for the following reasons (stating the reasons): I move the adop tion of Proposal No. lll.’’ A second will then be called for. If the rec ommendation is seconded, discussion and a formal vote will follow. (d) Each committee chairman shall present the proposals which his com mittee does not approve as follows: ‘‘Mr. Chairman. The Committee for Egg-type chickens does not approve Proposal No. lll.’’ The chairman will then ask if any official delegate wishes to move for the adoption of the proposal. If moved and seconded, the proposal is subject to discussion and voted. If there is no motion for ap proval, or if moved but not seconded, there can be no discussion or vote. (e) Discussion on any motion must be withheld until the motion has been properly seconded, except that the del egate making the motion is privileged, if he desires, to give reasons for his mo tion at the time of making it. To gain the floor for a motion or for discussion on a motion, the official delegate in the case of a motion, or anyone in case of discussion on a motion, shall rise, address the chair, give his name and State, and be recognized by the chair before proceeding further. While it is proper to accept motions only from of ficial delegates and to limit voting only to such delegates, it is, however, equally proper to accept discussion from anyone interested. To conserve time, discussion should be pointed and limited to the pertinent features of the motion. (f) Proposals that have not been sub mitted in accordance with § 147.44 will be considered by the conference only with the unanimous consent of the General Conference Committee. Any such proposals must be referred to the appropriate committee for consider ation before being presented for action by the conference. (g) Voting will be by States, and each official delegate, as determined by § 147.45, will be allowed one vote on each proposal pertaining to the pro gram prescribed by the subpart which he represents. (h) A roll call of States for a recorded vote will be used when requested by a delegate or at the discretion of the chairman. (i) All motions on proposed changes shall be for adoption. (j) Proposed changes shall be adopted by a majority vote of the official dele gates present and voting. (k) The conference shall be open to any interested person. [36 FR 23121, Dec. 3, 1971, as amended at 41 FR 48727, Nov. 5, 1976. Redesignated at 44 FR 61586, Oct. 26, 1979] § 147.48 Approval of conference rec ommendations by the Department. Proposals adopted by the official del egates will be recommended to the De partment for incorporation into the provisions of the NPIP. The Depart ment reserves the right to approve or disapprove the recommendations of the conference as an integral part of its sponsorship of the National Poultry Improvement Plan. Subpart F—Authorized Labora tories and Approved Tests and Sanitation Procedures SOURCE: 79 FR 38766, July 9, 2014, unless otherwise noted. VerDate Sep<11>2014 13:56 Feb 14, 2018 Jkt 244028 PO 00000 Frm 00976 Fmt 8010 Sfmt 8010 Q:\09\9V1.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 967 Animal and Plant Health Inspection Service, USDA § 147.53 § 147.51 Definitions. The following definitions apply in this subpart: Administrator. The Administrator, Animal and Plant Health Inspection Service, or any other employee of the Animal and Plant Health Inspection Service delegated to act in the Admin istrator’s stead. Animal and Plant Health Inspection Service (APHIS, the Service). The Animal and Plant Health Inspection Service of the U.S. Department of Agriculture. NPIP or Plan. The National Poultry Improvement Plan. NPIP Program Standards. A document that contains tests and sanitation pro cedures approved by the Administrator under § 147.53 for use under this sub chapter. This document may be ob tained from the NPIP Web site at http:// www.poultryimprovement.org/ or by writ ing to the Service at National Poultry Improvement Plan, APHIS, USDA, 1506 Klondike Road, Suite 101, Conyers, GA 30094. NPIP Technical Committee. A com mittee made up of technical experts on poultry health, biosecurity, surveil lance, and diagnostics. The committee consists of representatives from the poultry and egg industries, univer sities, and State and Federal govern ments and is appointed by the Senior Coordinator and approved by the Gen eral Conference Committee. § 147.52 Authorized laboratories. These minimum requirements are in tended to be the basis on which an au thorized laboratory of the Plan can be evaluated to ensure that official Plan assays are performed in accordance with the NPIP Program Standards or other procedures approved by the Ad ministrator in accordance with § 147.53(d)(1) and reported as described in paragraph (f) of this section. A satis factory evaluation will result in the laboratory being recognized by the NPIP office of the Service as an au thorized laboratory qualified to per form the assays provided for in this part. (a) Check-test proficiency. The NPIP will serve as the lead agency for the co ordination of available check tests from the National Veterinary Services Laboratories. The authorized labora tory must use a regularly scheduled check test for each assay that it per forms. (b) Trained technicians. The testing procedures at the laboratory must be run or overseen by a laboratory techni cian who has attended and satisfac torily completed Service-approved lab oratory workshops for Plan-specific diseases within the past 4 years. (c) Laboratory protocol. Official Plan assays must be performed and reported as described in the NPIP Program Standards or in accordance with other procedures approved by the Adminis trator in accordance with § 147.53(d)(1). Assays must be performed using con trol reagents approved by the Plan or the reagent manufacturer. (d) State site visit. The Official State Agency will conduct a site visit and recordkeeping audit at least once every 2 years. This will include, but may not be limited to, review of technician training records, check test pro ficiency, and test results. The informa tion from the site visit and record keeping audit will be made available to the NPIP upon request. (e) Service review. Authorized labora tories will be reviewed by the Service (NPIP staff) every 3 years. The Serv ice’s review may include, but will not necessarily be limited to, checking records, laboratory protocol, check test proficiency, technician training, and peer review. (f) Reporting. (1) A memorandum of understanding or other means shall be used to establish testing and reporting criteria to the Official State Agency, including criteria that provide for re porting H5 and H7 low pathogenic avian influenza directly to the Service. (2) Salmonella pullorum and Myco plasma Plan disease reactors must be reported to the Official State Agency within 48 hours. (g) Verification. Random samples may also be required to be submitted for verification as specified by the Official State Agency. [79 FR 38766, July 9, 2014, as amended at 81 FR 53251, Aug. 12, 2016]] § 147.53 Approved tests and sanitation procedures. (a)(1) All tests that are used to qual ify flocks for NPIP classifications must VerDate Sep<11>2014 13:56 Feb 14, 2018 Jkt 244028 PO 00000 Frm 00977 Fmt 8010 Sfmt 8010 Q:\09\9V1.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 968 9 CFR Ch. I (1–1–18 Edition) § 147.53 be approved by the Administrator as effective and accurate at determining whether a disease is present in a poul try flock or in the environment. (2) All sanitation procedures per formed as part of qualifying for an NPIP classification must be approved by the Administrator as effective at re ducing the risk of incidence of disease in a poultry flock or hatchery. (b) Tests and sanitation procedures that have been approved by the Admin istrator may be found in the NPIP Pro gram Standards. In addition, all tests that use veterinary biologics (e.g., antiserum and other products of bio logical origin) that are licensed or pro duced by the Service and used as de scribed in the NPIP Program Stand ards are approved for use in the NPIP. (c) New tests and sanitation proce dures, or changes to existing tests and sanitation procedures, that have been approved by the NPIP in accordance with the process described in subpart E of this part are subject to approval by the Administrator. NPIP participants may submit new tests and sanitation procedures, or changes to current tests and sanitation procedures, through that process. (d)(1) Persons who wish to have a test approved by the Administrator as ef fective and accurate at determining whether a disease is present in a flock or in the environment may apply for approval by submitting the test, along with any supporting information and data, to the National Poultry Improve ment Plan, APHIS, USDA, 1506 Klon dike Road, Suite 101, Conyers, GA 30094. Upon receipt of such an applica tion, the NPIP Technical Committee will review the test and any supporting information and data supplied with the application. If the NPIP Technical Committee determines the test to be of potential general use, the test will be submitted for consideration by the General Conference Committee of the NPIP in accordance with subpart E of this part, and the Administrator will respond with approval or denial of the test. (2) Persons who wish to have a sani tation procedure approved by the Ad ministrator as effective at reducing the risk of incidence of disease in a poultry flock or hatchery may apply for ap proval by submitting the sanitation procedure, along with any supporting information and data, to the National Poultry Improvement Plan, APHIS, USDA, 1506 Klondike Road, Suite 101, Conyers, GA 30094. Upon receipt of such an application, the NPIP Technical Committee will review the sanitation procedure and any supporting informa tion and data supplied with the appli cation. If the NPIP Technical Com mittee determines the sanitation pro cedure to be of potential general use, the sanitation procedure will be sub mitted for consideration by the Gen eral Conference Committee of the NPIP in accordance with subpart E of this part, and the Administrator will respond with approval or denial of the test. (e)(1) When the Administrator ap proves a new test or sanitation proce dure or a change to an existing test or sanitation procedure, APHIS will pub lish a notice in the FEDERAL REGISTER making available the test or sanitation procedure. The notice will also provide for a public comment period. (2)(i) After the close of the public comment period, APHIS will publish a notice in the FEDERAL REGISTER indi cating that the test or sanitation pro cedure will be added to the NPIP Pro gram Standards, or that the NPIP Pro gram Standards will be updated to re flect changes to an existing test or sanitation procedure, if: (A) No comments were received on the notice; (B) The comments on the notice sup ported the action described in the no tice; or (C) The comments on the notice were evaluated but did not change the Ad ministrator’s determination that ap proval of the test or sanitation proce dure is appropriate based on the stand ards in paragraph (a) of this section. (ii) If comments indicate that changes should be made to the test or sanitation procedure as it was made available in the initial notice, APHIS will publish a notice in the FEDERAL REGISTER indicating that changes were made to the initial test or sanitation procedure. (iii) Whenever APHIS adds or makes changes to tests or sanitation proce dures, APHIS will make available a VerDate Sep<11>2014 13:56 Feb 14, 2018 Jkt 244028 PO 00000 Frm 00978 Fmt 8010 Sfmt 8010 Q:\09\9V1.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 969 Animal and Plant Health Inspection Service, USDA § 147.54 new version of the NPIP Program Standards that reflects the additions or changes. (iv) If comments present information that causes the Administrator to deter mine that approval of the test or sani tation procedure would not be appro priate, APHIS will publish a notice in forming the public of this determina tion after the close of the comment pe riod. § 147.54 Approval of diagnostic test kits not licensed by the Service. (a) Diagnostic test kits that are not licensed by the Service (e.g., bacterio logical culturing kits) may be approved through the following procedure: (1) The sensitivity of the kit will be evaluated in at least three NPIP au thorized laboratories by testing known positive samples, as determined by the official NPIP procedures found in the NPIP Program Standards or through other procedures approved by the Ad ministrator. Field samples for which the presence or absence of the target organism or analyte has been deter mined by the current NPIP test should be used, not spiked samples or pure cultures. Samples from a variety of field cases representing a range of low, medium, and high analyte concentra tions should be used. In some cases it may be necessary to utilize samples from experimentally infected animals. Spiked samples (clinical sample matrix with a known amount of pure culture added) should only be used in the event that no other sample types are avail able. Pure cultures should never be used. Additionally, laboratories should be selected for their experience with testing for the target organism or analyte with the current NPIP ap proved test. If certain conditions or interfering substances are known to af fect the performance of the kit, appro priate samples will be included so that the magnitude and significance of the effect(s) can be evaluated. (2) The specificity of the kit will be evaluated in at least three NPIP au thorized laboratories by testing known negative samples, as determined by tests conducted in accordance with the NPIP Program Standards or other pro cedures approved by the Administrator in accordance with § 147.53(d)(1). If cer tain conditions or interfering sub stances are known to affect the per formance of the kit, appropriate sam ples will be included so that the mag nitude and significance of the effect(s) can be evaluated. (3) The kit will be provided to the co operating laboratories in its final form and include the instructions for use. The cooperating laboratories must per form the assay exactly as stated in the supplied instructions. Each laboratory must test a panel of at least 25 known positive samples. In addition, each lab oratory will be asked to test at least 50 known negative samples obtained from several sources, to provide a represent ative sampling of the general popu lation. The cooperating laboratories must perform a current NPIP proce dure or NPIP approved test on the sam ples alongside the test kit for compari son. (4) Cooperating laboratories will sub mit to the kit manufacturer all raw data regarding the assay response. Each sample tested will be reported as positive or negative, and the official NPIP procedure used to classify the sample must be submitted in addition to the assay response value. A com pleted worksheet for diagnostic test evaluation is required to be submitted with the raw data and may be obtained by contacting the NPIP Senior Coordi nator. Raw data and the completed worksheet for diagnostic test evalua tion must be submitted to the NPIP Senior Coordinator 4 months prior to the next scheduled General Conference Committee meeting, which is when ap proval will be sought. (5) The findings of the cooperating laboratories will be evaluated by the NPIP Technical Committee, and the Technical Committee will make a ma jority recommendation whether to ap prove the test kit to the General Con ference Committee at the next sched uled General Conference Committee meeting. If the Technical Committee recommends approval, the final ap proval will be granted in accordance with the procedures described in §§ 147.46, 147.47, and 147.48. (6) Diagnostic test kits that are not licensed by the Service (e.g., bacterio logical culturing kits) and that have been approved for use in the NPIP in VerDate Sep<11>2014 13:56 Feb 14, 2018 Jkt 244028 PO 00000 Frm 00979 Fmt 8010 Sfmt 8010 Q:\09\9V1.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 970 9 CFR Ch. I (1–1–18 Edition) Pt. 149 accordance with this section are listed in the NPIP Program Standards. (b) Approved tests modification and re moval. (1) The specific data required for modifications of previously approved tests will be taken on a case-by-case basis by the technical committee. (2) If the Technical Committee deter mines that only additional field data is needed at the time of submission for a modification of a previously approved test, allow for a conditional approval for 60 days for data collection side-by side with a current test. The submit ting party must provide complete pro tocol and study design, including cri teria for pass/fail to the Technical Committee. The Technical Committee must review the data prior to final ap proval. This would only apply to the specific situation where a modified test needs additional field data with poul try to be approved. (3) Approved diagnostic tests may be removed from the Plan by submission of a proposed change from a partici pant, Official State Agency, the De partment, or other interested person or industry organization. The data in sup port of removing an approved test will be compiled and evaluated by the NPIP Technical Committee, and the Tech nical Committee will make a majority recommendation whether to remove the test kit to the General Conference Committee at the next scheduled Gen eral Conference Committee meeting. If the Technical Committee recommends removal, the final decision to remove the test will be granted in accordance with the procedures described in §§ 147.46, 147.47, and 147.48. [81 FR 53251, Aug. 12, 2016] PART 149—VOLUNTARY TRICHINAE CERTIFICATION PROGRAM Sec. 149.0 Purpose and scope. 149.1 Definitions. 149.2 Program participation. 149.3 Site audit. 149.4 Spot audit. 149.5 Offsite identification and segregation of certified swine. 149.6 Slaughter facilities. 149.7 Recordkeeping at site. 149.8 Program fees and charges. 149.9 Pilot program sites. AUTHORITY: 7 U.S.C. 1622 and 8301–8317; 21 U.S.C. 136a; 7 CFR 2.22, 2.80, and 371.4. SOURCE: 73 FR 60479, Oct. 10, 2008, unless otherwise noted. § 149.0 Purpose and scope. The Trichinae Certification Program described in this part is intended to en hance the ability of swine producers, as well as slaughter facilities and other persons that handle or process swine from pork production sites that have been certified under the program, to export fresh pork and pork products to foreign markets. § 149.1 Definitions. Accredited veterinarian. A veteri narian approved by the APHIS Admin istrator in accordance with part 161 of this chapter to perform functions spec ified in subchapters B, C, D, and G of this chapter. Agricultural Marketing Service (AMS). The Agricultural Marketing Service of the United States Department of Agri culture. AMS Administrator. The Adminis trator, Agricultural Marketing Serv ice, or any person authorized to act for the AMS Administrator. AMS representative. Any individual employed by or acting as an agent on behalf of the Agricultural Marketing Service who is authorized by the AMS Administrator to perform services re quired by this part. Animal and Plant Health Inspection Service (APHIS). The Animal and Plant Health Inspection Service of the United States Department of Agriculture. Animal disposal plan. A written docu ment that describes methods for the re moval and disposal of dead swine or swine remains from a pork production site. Animal movement record. A written record of the movement of swine into or from a pork production site. APHIS Administrator. The Adminis trator, Animal and Plant Health In spection Service, or any person author ized to act for the APHIS Adminis trator. APHIS representative. Any individual employed by or acting as an agent on behalf of the Animal and Plant Health Inspection Service who is authorized VerDate Sep<11>2014 13:56 Feb 14, 2018 Jkt 244028 PO 00000 Frm 00980 Fmt 8010 Sfmt 8010 Q:\09\9V1.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 971 Animal and Plant Health Inspection Service, USDA § 149.1 1 The labeling of all certified pork or pork products leaving a slaughter or processing facility must comply with 9 CFR 317.4 and all other applicable FSIS labeling regulations. by the APHIS Administrator to per form the services required by this part. Approved laboratory. A non-Federal laboratory approved by the Agricul tural Marketing Service and recog nized by the APHIS Administrator or FSIS Administrator for performing validated tests to determine the pres ence of trichinae infection in reference to the Trichinae Certification Pro gram. Audit. An inspection process, as pro vided in this part, that generates a written record documenting a pork production site’s adherence to the re quired good production practices. Auditor. A qualified accredited veteri narian (QAV) or a qualified veterinary medical officer (QVMO) who is trained and authorized by APHIS to perform auditing activities under the Trichinae Certification Program. Certification (certified). A designation given by the APHIS Administrator to a pork production site for compliance with good production practices and other program requirements of the Trichinae Certification Program as provided in this part. Certified pork. Pork products origi nating from certified swine from a cer tified production site with identity of such animals or carcasses maintained throughout receiving, handling, and processing. 1 Certified production site. A pork pro duction site that has attained a pro gram status of Stage II or higher, based on adherence to good production practices and other program require ments as provided in this part. Certified swine. Swine produced under the Trichinae Certification Program on a certified production site. Confinement unit. A structure on a pork production site in which swine are housed and fed that is totally roofed and that is constructed in such a man ner as to prevent swine from being ex posed to free-flying birds and other wildlife, and from coming into contact with the carrion of free-flying birds or other wildlife. Decertification (decertified). Removal of the certified status of a production site by the APHIS Administrator when it has been determined that the cri teria of the Trichinae Certification Program are not being met or main tained. Enzyme-linked immunosorbent assay (ELISA). A method of testing swine for the presence of trichinae infection by looking for antibodies to Trichinella spp. in the sera, plasma, whole blood, tissue fluid, or meat juice of swine. EPA. The United States Environ mental Protection Agency. Feed mill quality assurance affidavit. A written statement signed by the feed mill representative and the producer that documents the quality and safety of feed or feed ingredients delivered from the feed mill to the pork produc tion site. Food Safety and Inspection Service (FSIS). The Food Safety and Inspection Service of the United States Depart ment of Agriculture. FSIS Administrator. The Adminis trator, Food Safety and Inspection Service, or any person authorized to act for the Administrator. FSIS program employee. Any indi vidual employed by or acting as an agent on behalf of the Food Safety and Inspection Service who is authorized by the FSIS Administrator to perform the services required by this part. Good manufacturing practices. Feed manufacturing practices that reduce, eliminate, or avoid the risk of exposure of swine to Trichinella spp. Good production practices. Pork pro duction management practices that re duce, eliminate, or avoid the risk of ex posure of swine to Trichinella spp. Harborage. Any object, debris, clut ter, or area that could serve as shelter or refuge for rodents or wildlife. Laboratory approval audit. An audit performed by AMS representatives to determine if a laboratory meets min imum requirements for approval, as es tablished by AMS, for performing vali dated tests under this part. National Trichinae Certified Herd. All swine raised on certified production sites in the United States. Person. Any individual, corporation, company, association, firm, partner ship, society, joint stock company, or other legal entity. VerDate Sep<11>2014 13:56 Feb 14, 2018 Jkt 244028 PO 00000 Frm 00981 Fmt 8010 Sfmt 8010 Q:\09\9V1.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 972 9 CFR Ch. I (1–1–18 Edition) § 149.1 2 Accredited veterinarians interested in ob taining program certification related to the Trichinae Certification Program should con tact APHIS’ National Trichinae Coordinator at (515) 284–4122 or write to: USDA, APHIS, Veterinary Services, Trichinae Certification Program, 210 Walnut St., Room 891, Des Moines, IA 50309. Pest control operator. A person trained and State-licensed in the control of pests and vermin (particularly ro dents). Pooled sample digestion method (diges tion method). A method of testing swine for trichinae infection by identifying the presence of Trichinella spp. from a sample of the animal’s muscle tissue. Pork production site (site). A geo graphically definable area that in cludes pork production facilities and ancillary structures under common ownership or management systems and the surrounding space within a 100-foot perimeter of the confinement unit. Positive test result. Outcome of a vali dated test indicating the presence of Trichinella spp. Premises Identification Number (PIN). A number assigned to a pork produc tion site by the APHIS Administrator. Process-verification testing. Testing of a statistically valid sample of swine belonging to the National Trichinae Certified Herd at the time of slaughter using a validated test to verify that the adherence to good manufacturing practices and good production prac tices is resulting in the absence of Trichinella spp. infection in swine from that herd. Producer. An individual or entity that owns or controls the production or management of swine. Qualified accredited veterinarian (QAV). An accredited veterinarian who has been granted a program certifi cation by the APHIS Administrator pursuant to § 161.5 of this chapter based on completion of an APHIS-approved training program in good production practices in swine management, and who is authorized by the APHIS Ad ministrator to perform site audits and other specified program services re quired by this part. 2 Qualified veterinary medical officer (QVMO). A VMO of the State or Fed eral Government who is trained in good production practices and is authorized by the APHIS Administrator to per form site audits, spot audits, and other specified program services required by this part. Rodent control logbook. A written record that documents a rodent control program for a pork production site. Site audit. An audit, performed by a QAV or a QVMO, to determine the trichinae risk factor status of a pork production site based on the site’s ad herence to all of the required good pro duction practices that reduce, elimi nate, or avoid the risk of exposure of swine to Trichinella spp. Slaughter facility. A slaughtering es tablishment operating under the Fed eral Meat Inspection Act (21 U.S.C. 601 et seq.) or a State meat inspection act that receives certified swine under the Trichinae Certification Program. Slaughter facility representative. Any individual employed by, or acting as an agent on behalf of, a slaughter facility who is authorized by the slaughter fa cility to perform the specified program services required by this part. Spot audit. An audit of a certified pork production site performed by a QVMO to ensure program integrity and consistency. Stage I enrolled. Preliminary program status of a pork production site at tained when the APHIS Administrator approves the outcome of an initial site audit. Stage II certified. Program status at tained upon APHIS approval of a site audit of a Stage I enrolled site. Stage III certified. Program status at tained upon APHIS approval of a site audit of a Stage II certified site and maintained upon APHIS approval of subsequent site audits for renewal of Stage III certified status. Sterile zone. An open area imme diately adjacent to and surrounding the confinement unit that serves as both a buffer and detection zone for ro dent and wildlife activity. Temporary withdrawal. The voluntary withdrawal of a certified production site from the Trichinae Certification Program at the request of the producer for a period not to exceed 180 days. Trichinae. A generic term that refers to Trichinella spp. Trichinae Certification Program (pro gram). A voluntary pre-harvest pork VerDate Sep<11>2014 13:56 Feb 14, 2018 Jkt 244028 PO 00000 Frm 00982 Fmt 8010 Sfmt 8010 Q:\09\9V1.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 973 Animal and Plant Health Inspection Service, USDA § 149.2 safety program in which APHIS cer tifies pork production sites that follow all of the required good production practices that reduce, eliminate, or avoid the risk of exposure of swine from their sites to Trichinella spp. Trichinella spp. Parasitic nematodes (roundworms) capable of infecting many warm-blooded carnivores and omnivores, including swine. USDA. The United States Depart ment of Agriculture. Validated test. An analytical method licensed by APHIS or accepted by AMS for the diagnosis of Trichinella spp. in swine. Veterinary medical officer (VMO). A veterinarian employed by the State or Federal Government who is authorized to perform official animal health ac tivities on their behalf. [73 FR 60479, Oct. 10, 2008, as amended at 74 FR 65010, Dec. 9, 2009] § 149.2 Program participation. A producer’s initial enrollment and continued participation in the Trichinae Certification Program re quires that the producer adhere to all of the good production practices, as confirmed by periodic site audits, and comply with other recordkeeping and program requirements provided in this part. Pork production sites accepted into the program by APHIS will par ticipate under one of the following three program stages: (a) Stage I enrolled status. (1) Stage I enrolled status signifies that the site has met good production practices and other recordkeeping and program re quirements provided in this part. (2) Swine from a Stage I enrolled site cannot be identified as products from a certified production site. (3) A Stage I enrolled site must com plete a site audit for Stage II certified status in accordance with § 149.3(d). Under § 149.3(d), the site audit must be performed no sooner than 150 days from the date the site was awarded Stage I enrolled status, and must be com pleted, with the audit form and pay ment submitted to APHIS, no later than 210 days from the date the site was awarded Stage I enrolled status. (4) A Stage I enrolled site that is found not to be adhering to one or more good production practices as a re sult of a site audit or spot audit, or that fails to follow the prescribed time table for completing a site audit and submitting the completed audit form and payment for consideration as a Stage II certified site, will be subject to a review by APHIS to consider the nature of the infraction(s), and may lose its status as a Stage I enrolled site. (b) Stage II certified status. (1) Stage II certified status signifies that the site is adhering to all of the required good production practices and other record keeping and program requirements pro vided in this part. (2) An APHIS-issued certificate or letter indicating the site’s status as a Stage II certified site must be filed at the site and be readily available for in spection. (3) Swine from a Stage II certified site may be identified as certified prod ucts from a certified production site. (4) A Stage II certified site must complete a site audit for Stage III cer tified status in accordance with § 149.3(e). Under § 149.3(e), the site audit must be performed no sooner than 240 days from the date the site was award ed Stage II certified status, and must be completed, with the audit form and payment submitted to APHIS, no later than 300 days from the date the site was awarded Stage II certified status. (5) A Stage II certified site that is found not to be adhering to one or more good production practices as a re sult of a site audit or spot audit, or that fails to meet the Stage III site audit requirements of § 149.3(e) within the prescribed timetable, will be sub ject to a review by APHIS to consider the nature of the infraction(s) and de termine whether to decertify the site, as provided in paragraph (e)(1) of this section. During the time a site is decer tified, swine from that site cannot be identified as certified products from a certified production site. (c) Stage III certified status. (1) Stage III certified status signifies that the site is adhering to all of the required good production practices and other recordkeeping and program require ments provided in this part. (2) An APHIS-issued certificate or letter indicating the site’s status as a Stage III certified site must be filed at VerDate Sep<11>2014 13:56 Feb 14, 2018 Jkt 244028 PO 00000 Frm 00983 Fmt 8010 Sfmt 8010 Q:\09\9V1.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 974 9 CFR Ch. I (1–1–18 Edition) § 149.2 the site and be readily available for in spection. (3) Swine from a Stage III certified site may be identified as certified prod ucts from a certified production site. (4) In order to maintain Stage III cer tified status, sites must arrange for site audits to renew such status ac cording to the timetable set forth in § 149.3(f). Under § 149.3(f), the site audit must be performed no sooner than 14 months from the date the site was awarded Stage III certified status or the date that status was last renewed, and must be completed, with the audit form and payment submitted to APHIS, no later than 16 months from either the date the site was awarded Stage III certified status or the date that status was last renewed. (5) A Stage III certified site that is found not to be adhering to one or more good production practices as a re sult of a site audit or spot audit, or that fails to follow the prescribed time table for completing a site audit and submitting the completed audit form and payment to determine its contin ued participation as a Stage III cer tified site, will be subject to a review by APHIS to consider the nature of the infraction(s) and determine whether to decertify the site, as provided in para graph (e)(1) of this section. During the time a site is decertified, swine from that site cannot be identified as cer tified products from a certified produc tion site. (d) Change of ownership—(1) Stage I enrolled site. If there is a change in ownership in a Stage I enrolled site, and the new ownership wishes to re main in the program, then the Stage I enrolled site will remain on the same timetable as under the previous owner ship for purposes of completing a site audit for Stage II certified status. No additional site audit is necessary as a result of the change of ownership of the site. (2) Stage II or Stage III certified sites. When a change of ownership occurs at a Stage II or Stage III certified site, the previous owner of the site must no tify APHIS of this change as soon as the transaction is finalized. Within 60 days of this notification, a site audit must be performed in order for the site to maintain its certified status. It is the new ownership’s responsibility that a site audit be performed within 60 days of this notification, otherwise the site may be subject to decertification, in accordance with paragraph (e)(1) of this section. If the site audit is satis factory, then the Stage II or Stage III certified site will continue in the pro gram, initially as a Stage II certified site. However, a new program anniver sary date for that site will be estab lished based on the date the site was audited to continue in the program as a Stage II certified site, and the pro ducer of the site must arrange for a site audit to gain (or regain) Stage III certified status based on that new an niversary date and according to the timetable prescribed in § 149.3(e). If the results of the site audit do not meet program requirements, the Stage II or Stage III site will be subject to a re view by APHIS to consider the nature of the infraction(s) and determine whether to decertify the site, as pro vided in paragraph (e)(1) of this sec tion. Once a site is decertified by APHIS, either because the new owner ship fails to arrange for a site audit to be performed within the allotted 60-day time period, or because the site is found not to meet program require ments, a producer wishing to partici pate in the program again must follow the procedures for requesting an initial audit for Stage I enrolled status. If a decertified site is reenrolled after a successful Stage I site audit, a new pro gram anniversary date for that site will be established based on the date of reenrollment. (e) Site decertification and program withdrawal—(1) Decertification by APHIS. (i) A Stage II or Stage III cer tified site that is found not to be ad hering to one or more of the good pro duction practices as a result of a site audit, or that fails to follow the pre scribed timetable for completing a site audit and submitting the completed audit form and payment to continue participation in the program, will be subject to a review by APHIS to con sider the nature of the infraction(s) and to determine whether the site should be decertified. Decertification will result from infraction(s) that APHIS determines to be substantive, VerDate Sep<11>2014 13:56 Feb 14, 2018 Jkt 244028 PO 00000 Frm 00984 Fmt 8010 Sfmt 8010 Q:\09\9V1.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 975 Animal and Plant Health Inspection Service, USDA § 149.2 prolonged, and/or repeated as a result of this review. (ii) During the time a site is decerti fied, swine from such sites cannot be identified as certified products from a certified production site. (iii) Once a site is decertified by APHIS, a producer wishing to partici pate in the program again must follow the procedures for requesting a site audit for Stage I enrolled status. If a decertified site is reenrolled after a successful Stage I site audit, a new pro gram anniversary date for that site will be established based on the date of recertification. If a decertified site is recertified after a successful Stage II site audit, a new program anniversary date for that site will be established based on the date of recertification. (2) Temporary withdrawal by producer. (i) A producer may request that one or more certified production sites be tem porarily withdrawn. A producer’s re quest must be made in writing and is subject to the APHIS Administrator’s approval. (ii) Each certified production site can be temporarily withdrawn no more than once every 2 years for a period not to exceed 180 days. (iii) During the time a site is tempo rarily withdrawn: (A) Swine from such sites cannot be identified as certified products from a certified production site; and (B) The producer must continue to adhere to all good production practices and other recordkeeping and program requirements provided in this part, in cluding documentation in the animal movement record of the arrival and de parture of all swine from this site, as well as whether the swine arriving at the site are from certified or noncer tified sources, unless a program re quirement is specifically waived by the Administrator. (iv) If granted a waiver by the Ad ministrator, a producer may receive swine 5 weeks of age or older origi nating from a noncertified source dur ing the period of withdrawal. (v) Before being reinstated as a cer tified production site, the temporarily withdrawn site must pass a site audit to indicate that it is now adhering to all good production practices (includ ing any practices waived by the Admin istrator at the beginning of the period of withdrawal) as follows: (A) The site audit must be performed while the site is still under temporary withdrawal status. If swine 5 weeks of age or older originating from a noncer tified source have been received at the site during the time of withdrawal, then the site audit for reinstatement must be performed within 30 days of the date the last swine from a noncer tified source was removed from the site, but no later than 180 days from the date the site was granted tem porary withdrawal status. (B) If the results of the site audit are satisfactory and it is determined that the site is now adhering to good pro duction practices and other program requirements provided in this part, then the withdrawn site will be rein stated as a Stage II certified site. The timetable for performing future site audits for attaining and renewing Stage III certified status will be based on the date the site was reinstated as a Stage II certified site. (C) If the results of the site audit are not satisfactory, or, if the period of temporary withdrawal has exceeded 180 days, then the site will be subject to a review by APHIS to consider the na ture of the infraction(s) and to deter mine whether to decertify the site, as provided in paragraph (e)(1) of this sec tion. Once the site is decertified by APHIS, the producer must follow the procedures for requesting an initial site audit for Stage I enrolled status in order for the site to be reenrolled in the program. If a site is decertified by APHIS and then reenrolled after a suc cessful Stage I site audit, a new pro gram anniversary date for that site will be established based on the date of enrollment. (3) Program withdrawal. (i) If a pro ducer decides to withdraw one or more of pork production sites from the pro gram, then it is the producer’s respon sibility to notify the APHIS Adminis trator in writing of this intent. When this is done, the site will be removed from the program. (ii) If at a later date the producer re quests that a site be reinstated in the program, then the producer must fol low the procedures for requesting an VerDate Sep<11>2014 13:56 Feb 14, 2018 Jkt 244028 PO 00000 Frm 00985 Fmt 8010 Sfmt 8010 Q:\09\9V1.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 976 9 CFR Ch. I (1–1–18 Edition) § 149.3 initial audit for Stage I enrolled sta tus. If a withdrawn site is reenrolled after a successful Stage I site audit, then a new program anniversary date for that site will be established based on the date of reenrollment. (f) Request for review. If there is a con flict as to any material fact relating to the results of a site audit, spot audit, or other determination affecting a pro ducer’s program status or ability to participate in the program, the pro ducer may submit a written request for review to the Administrator. The pro ducer must include in the request the reasons, including any supporting doc umentation, why the audit result or other determination should be dif ferent than the result or determination made by the Administrator. The initial audit result or other determination will remain in force pending the com pletion of the Administrator’s review. The decision by the Administrator upon reviewing the producer’s written request will be final. § 149.3 Site audit. (a) General. (1) The producer must contact a QAV or QVMO to request a site audit. A list of available QAVs may be obtained by accessing the Trichinae Certification Program Web site on the Internet at http:// www.aphis.usda.gov/vs/trichinae. If a QAV is not available to perform a site audit, the producer must then contact the APHIS area office to request that a QVMO perform the site audit. The site audit is to be arranged at a mutually agreed-upon time. (2) The producer or the producer’s designated representative will accom pany the auditor during the site audit. (3) During the site audit, the auditor will record whether the producer is ad hering to all of the required good pro duction practices at the site, as pro vided in paragraph (b) of this section, in order to reduce, eliminate, or avoid the risk of exposure of swine to Trichinella spp. (4) The auditor will use APHIS-ap proved audit forms in performing the site audit. After the auditor has com pleted all sections of the audit form, the producer or the producer’s des ignated representative must sign the audit form attesting to the accuracy of the information obtained during the site audit and to evidence his or her in tent to continue adhering to the good production practices and other pro gram requirements, as provided in this part. The auditor also must sign the audit form at this time. (5) If a QVMO performs the site audit, then the producer will pay the QVMO at the time the site audit is performed in accordance with the rate and other conditions set by the QVMO’s govern mental employer. If an APHIS-em ployed QVMO performs the site audit, then the producer will pay APHIS by certified check or U.S. money order for this service at a rate determined in ac cordance with § 149.8. (6) In addition to the possible cost of the site audit, the producer is also re sponsible for paying a separate pro gram fee in an amount specified in § 149.8 to cover APHIS’ administrative costs in processing the audit and oper ating the program. This program fee, payable to APHIS by certified check or U.S. money order, must be remitted to the auditor at the time each site audit is performed. (7) The auditor will submit the com pleted audit form, program fee, and payment for the services of an APHIS employed QVMO, if applicable, to the nearest APHIS area office. If a QAV performs the site audit, the producer will be responsible for ensuring that the QAV submits the completed audit form and program fee to APHIS in a timely manner. (8) Upon receipt of the completed audit form and payment, APHIS will determine the initial enrollment or certification status for the site based on an evaluation of the site audit. APHIS will provide the producer with written notification of the audit re sults. Pork production sites that meet all good production practices as pro vided in paragraph (b) of this section, as well as other program requirements provided in this part, will be issued program status at the appropriate pro gram stage. (9) If the site audit shows that the site does not substantively meet all good production practices or other pro gram requirements, APHIS will provide the producer with written notification VerDate Sep<11>2014 13:56 Feb 14, 2018 Jkt 244028 PO 00000 Frm 00986 Fmt 8010 Sfmt 8010 Q:\09\9V1.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 977 Animal and Plant Health Inspection Service, USDA § 149.3 that includes documentation of the de ficiencies that prevented the site from being conferred program status. (b) Good production practices. In a site audit, the auditor will determine whether all of the required good pro duction practices are being carried out at the site to reduce, eliminate, or avoid the risk of exposure of swine to Trichinella spp. as follows: (1) The movement of all non-breeding swine 5 weeks of age or older into or from the pork production site must be documented in an animal movement record, as provided in § 149.7, that en sures that all such swine moved into or from the site can be subsequently traced back to that site, or to any pre vious site (if applicable). (2) All non-breeding swine entering a site must have originated from another certified production site, except that non-breeding swine less than 5 weeks of age may have originated from either a certified or noncertified production site. The animal movement record must include the PIN of the certified production site from which the swine originated. If the swine are less than 5 weeks of age and come from a noncer tified site, then the animal movement record must provide the name and full address of the noncertified site where the swine originated. (3) Feed or feed ingredients from off site sources that are used at the site must meet good manufacturing prac tices or other quality assurance stand ards recognized by the feed industry. The adherence to good manufacturing practices or other quality assurance standards must be documented in a feed mill quality assurance affidavit, as provided in § 149.7. (4) Swine at the site must be housed and fed in a confinement unit. The con finement unit, feed preparation and storage areas, and office areas and con necting hallways at the site must be inspected regularly and found free of signs of rodent and wildlife activity (evidence of rodent activity consists of fresh rodent droppings, fresh gnawing marks, new structural damage, rodent urine, rodent blood, rodent smear marks (body oil), rodent tracks, or re cent burrowing or burrow use. Evi dence of wildlife activity consists of wildlife feces, footprints, fur, or hair observed in or near the stored feed or feed ingredients, dead or live wildlife observed in or near the stored feed or feed ingredients, or wildlife burrows or nests observed in or near the stored feed or feed ingredients). Any movable harborage (exterior or interior) on the site that is not necessary to the day to-day operation of the site must be re moved. Harborage that cannot be re moved or is movable but necessary to the day-to-day operation of the site (e.g., equipment) must be checked for signs of rodent or wildlife activity. In addition, domesticated animals, in cluding pets such as dogs and cats, must be excluded from the confinement unit and feed preparation and storage areas at the site. Exterior rodent bait stations and/or traps must be placed around the perimeter of the confine ment unit. Exterior rodent bait sta tions and/or traps also must be placed around areas of potential rodent entry into the confinement unit (i.e., door ways, vent openings, loading chutes, cool cells, etc.). Interior rodent bait stations and/or traps must be placed near high-risk rodent zones such as entryways, hallways, office areas, swine load-out areas, vents, cool cells, storage areas, utility rooms, cabinets, locker rooms, bathrooms, and break rooms, and systematically maintained. Interior rodent bait stations and/or traps must be placed so that swine will not come in contact with the bait or trap. Rodent bait stations and/or traps also must be placed near exterior or in terior harborage on the site that can not be removed or that is movable but necessary to the day-to-day operation of the site. In all instances, rodent bait stations must be intact, systematically maintained, and contain fresh bait that consists of an EPA-registered rodenticide formulation that is applied according to its label. In addition, a sterile zone must be maintained around the perimeter of the confinement unit. The sterile zone must be devoid of any harborage or feed or water sources that could attract rodents or wildlife, but must contain rodent bait stations and/ or rodent traps. The sterile zone also must be devoid of any vegetation un less it is decorative vegetation that is well maintained (i.e., residential height VerDate Sep<11>2014 13:56 Feb 14, 2018 Jkt 244028 PO 00000 Frm 00987 Fmt 8010 Sfmt 8010 Q:\09\9V1.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 978 9 CFR Ch. I (1–1–18 Edition) § 149.3 3 The pre-audit information packet may be obtained from a qualified accredited veteri narian (QAV), State or Federal animal health offices, or the National Pork Board, or by writing to: USDA, APHIS, Veterinary Services, Trichinae Certification Program, 210 Walnut St., Room 891, Des Moines, IA 50309. A pre-audit packet also may be re quested electronically through the program Web site on the Internet at http:// www.aphis.usda.gov/vs/trichinae. grass, flowers, shrubs, or trees). A ster ile zone with decorative vegetation will require increased rodent control meas ures. The producer must provide docu mentation of rodent control practices by maintaining at the site an up-to date rodent control logbook with a site diagram and other recordkeeping evi dencing implementation of rodent con trol measures, which can include docu ments provided by a pest control oper ator, as provided in § 149.7. (5) Feed or feed ingredients stored at the site must be prepared, maintained, and handled in a manner that protects the feed or feed ingredients from pos sible exposure to or contamination by rodents or wildlife. Any movable har borage in the immediate vicinity of feed production and feed storage areas that is not necessary to the day-to-day operation of the site must be removed. Harborage that cannot be removed or harborage that is movable but nec essary to the day-to-day operation of the site (e.g., equipment, etc.) must be checked for signs of rodent or wildlife activity. Rodent bait stations and/or traps must be placed around (and in, if applicable) all feed preparation and storage areas, as well as near any har borage in the vicinity that cannot be removed or that is movable but nec essary to the day-to-day operation of the site. Rodent bait stations must be intact, systematically maintained, and contain fresh bait that consists of an EPA-registered rodenticide formula tion that is applied according to its label. In addition, feed or feed ingredi ents that are stored in paper bags must be elevated off the floor and be a suffi cient distance away from the walls to allow for inspection, baiting, and/or trapping. The rodent control logbook, as provided in § 149.7, must document that adequate rodent control proce dures have been implemented in the feed production and feed storage areas. (6) Swine must not have access to dead or live wildlife at the site. Dead or live wildlife must not be intentionally fed to swine. (7) Swine at the site must not be fed waste that contains meat. (8) Procedures must be in place and carried out for the prompt removal and proper disposal of dead swine or swine remains found in pens in order to eliminate the opportunity for canni balism, as well as to prevent the at traction of rodents or wildlife. Such procedures must be documented in the animal disposal plan, as provided in § 149.7. (9) General hygiene and sanitation of the site must be maintained at all times to prevent the attraction of ro dents and wildlife. Solid non-fecal waste (facility refuse) must be placed in covered receptacles and be regularly removed from the site. Spilled feed also must be regularly removed and prop erly disposed of. (10) All records required under § 149.7 must be kept up to date and readily available for inspection at the site. (c) Initial site audit for Stage I enrolled status. (1) Producers interested in par ticipating in the program should re quest and review a pre-audit informa tion packet prepared by APHIS that discusses the program, as well as the steps in preparing for and requesting an initial site audit. 3 When the pro ducer and the producer’s herd health personnel believe that a site meets pro gram standards, the producer must ar range for an initial site audit, as pro vided in paragraph (a) of this section. (2) Upon completion of the initial site audit and submission of the com pleted audit form and payment, APHIS will review the completed audit form and make a determination within 30 days as to enrollment of the site in the program. A pork production site that is found to meet all good production prac tices and other program requirements in this part will be awarded Stage I en rolled status. (d) Site audit for Stage II certified sta tus. (1) A producer of a Stage I enrolled site must arrange for another site audit for Stage II certified status. The site audit must be performed no sooner than 150 days (i.e., approximately 5 VerDate Sep<11>2014 13:56 Feb 14, 2018 Jkt 244028 PO 00000 Frm 00988 Fmt 8010 Sfmt 8010 Q:\09\9V1.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 979 Animal and Plant Health Inspection Service, USDA § 149.4 months) from the date the site was awarded Stage I enrolled status, and must be completed, with the audit form and payment submitted to APHIS, no later than 210 days (i.e., ap proximately 7 months) from the date the site was awarded Stage I enrolled status. (2) APHIS will review the completed audit form and make a determination as to Stage II certified status within 7 days of receipt of the audit form and payment. (i) A Stage I enrolled site that is found to meet all good production prac tices and other program requirements in this part will be awarded Stage II certified status. (ii) A Stage I enrolled site that is found, during a site audit, not to be ad hering to one or more good production practices, or that fails to follow the prescribed timetable for completing a site audit and submitting the com pleted audit form and payment, will be subject to a review by APHIS to con sider the nature of the infraction(s), and may lose its status as a Stage I site. (e) Site audit for Stage III certified sta tus. (1) A producer of a Stage II en rolled site must arrange for another site audit for Stage III certified status. The site audit must be performed no sooner than 240 days (i.e., approxi mately 8 months) from the date the site was awarded Stage II certified sta tus, and must be completed, with the audit form and payment submitted to APHIS, no later than 300 days (i.e., ap proximately 10 months) from the date the site was awarded Stage II certified status. (2) APHIS will review the completed audit form and make a determination as to Stage III certified status within 30 days of receipt of the audit form and payment. (i) A Stage II certified site that is found to meet all good production prac tices and other program requirements in this part will be awarded Stage III certified status. (ii) A Stage II certified site that is found, during a site audit, not to be ad hering to one or more good production practices, or that fails to follow the prescribed timetable for completing a site audit and submitting the com pleted audit form and payment, will be subject to a review by APHIS to con sider the nature of the infraction(s) and determine whether to decertify the site, as provided in § 149.2(e)(1). (f) Site audit for renewal of Stage III certified status. (1) A producer seeking to renew a site’s Stage III certified sta tus must arrange for another site audit. The site audit must be per formed no sooner than 14 months from the date the site was awarded Stage III certified status or the date that status was last renewed, and must be com pleted, with the audit form and pay ment submitted to APHIS, no later than 16 months from either the date the site was awarded Stage III certified status or the date the that status was last renewed. (2) APHIS will review the completed audit form and make a determination as to renewing the site’s Stage III cer tified status within 30 days of receipt of the audit form and payment. (i) A Stage III certified site that is found to meet all good production prac tices and other program requirements in this part will have its status as a Stage III certified site renewed. (ii) A Stage III certified site that is found, during a site audit, not to be ad hering to one or more good production practices, or that fails to follow the prescribed timetable for completing a site audit and submitting the com pleted audit form and payment, will be subject to a review by APHIS to con sider the nature of the infraction(s) and determine whether to decertify the site, as provided in § 149.2(e)(1). (Approved by the Office of Management and Budget under control number 0579–0323) § 149.4 Spot audit. (a) In addition to regularly scheduled site audits, certified production sites will be subject to spot audits. (1) Random spot audit. Certified pro duction sites will be selected by the APHIS Administrator at random for a spot audit in order to: (i) Ensure the integrity of the audit process; (ii) Verify that the audit process is performed in a consistent manner across the program; and VerDate Sep<11>2014 13:56 Feb 14, 2018 Jkt 244028 PO 00000 Frm 00989 Fmt 8010 Sfmt 8010 Q:\09\9V1.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 980 9 CFR Ch. I (1–1–18 Edition) § 149.5 (iii) Verify that all required good production practices are being main tained between regularly scheduled site audits. (2) Spot audit for cause. A certified production site may be subject to a spot audit to trace back and inves tigate any positive test results as a re sult of testing of certified swine from that site at the slaughter facility. (b) All spot audits will be performed by a QVMO. The producer of the cer tified production site subject to spot audit will not be charged for the spot audit. APHIS will provide the producer with written notification of the results of the spot audit, including documenta tion of any deficiencies noted during the audit. If the site is found not to be adhering to one or more of the required good production practices, then the site will be subject to a review by APHIS to consider the nature of the in fraction and to determine whether to decertify the site, as provided in § 149.2(e)(1). Unless a spot audit results in decertification, it does not otherwise affect the timetables for the comple tion of site audits set forth in para graphs (e) and (f) of § 149.3. § 149.5 Offsite identification and seg regation of certified swine. Certified swine moved from a cer tified production site to another loca tion, whether to another certified pro duction site, buying station, collection point, or slaughter facility, must re main segregated from noncertified swine at all times and otherwise main tain their identity as certified swine in such a way that they could be readily traced back to the certified production site from which they came. Informa tion relating to the identification of the certified swine must be docu mented in the animal movement record maintained by the producer. Failure to properly segregate or maintain the identity of certified swine from noncer tified swine after leaving the certified production site will result in the loss of certified status for that shipment of swine. § 149.6 Slaughter facilities. Only slaughter facilities that are under continuous inspection by the Food Safety and Inspection Service or under State inspection that the Food Safety and Inspection Service has rec ognized as equivalent to Federal in spection may participate in the pro gram. To participate in the program, slaughter facilities must follow the rel evant provisions of this section relat ing to verification, segregation, test ing, and recordkeeping. Participating slaughter facilities that fail to comply with any of the applicable require ments of this section will not be al lowed to continue to participate in the Trichinae Certification Program and the pork or pork products prepared by the facility will not be eligible for a certificate of export that identifies the product as meeting the standards of the Trichinae Certification Program. (a) Verification of certification. A slaughter facility receiving certified swine must verify the current certifi cation status of the pork production site from which the animals came. The current certification status may be verified by maintaining dated certifi cation documentation on file or by ac cessing the Trichinae Certification Program Web site on the Internet at http://www.aphis.usda.gov/vs/trichinae. If the slaughter facility is unable to verify a site’s certification status through documentation on file or through the program Web site, the slaughter facility then should contact the APHIS area office in the State where the site is located. (b) Maintaining identity and segrega tion of certified swine and pork products. For certified swine to be identified as certified pork, certified swine and edi ble pork products derived from cer tified swine must remain segregated from swine and edible pork products from noncertified sites throughout re ceiving, handling, and processing at the slaughter facility, as well as while awaiting shipment from the facility. The slaughter facility must maintain the identity of the certified swine or pork in a manner that allows the cer tified swine or pork to be traced back to the certified production site from which it came. A slaughter facility’s failure to properly segregate or main tain the identity of certified swine and edible pork products derived from the certified swine will result in the loss of certified status for that shipment of VerDate Sep<11>2014 13:56 Feb 14, 2018 Jkt 244028 PO 00000 Frm 00990 Fmt 8010 Sfmt 8010 Q:\09\9V1.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 981 Animal and Plant Health Inspection Service, USDA § 149.6 4 A copy of the testing methods and check list for conducting validated tests may be obtained by contacting the AMS Trichinae Analyst and Laboratory Certification Pro gram Manager, USDA, AMS, Science and Technology Programs, Technical Services Branch, 1400 Independence Ave., SW., Mail Stop 0272, Washington, DC 20250–0272. The manager may be contacted by phone at (202) 690–0621. 5 A copy of the AMS Trichinae Accredited Laboratory Program Requirements may be obtained by contacting the AMS Trichinae Analyst and Laboratory Certification Pro gram Manager (see footnote 4). 6 More information regarding sampling sizes may be obtained by writing to USDA, APHIS, Veterinary Services, Trichinae Cer tification Program, 210 Walnut St., Room 891, Des Moines, IA 50309. swine, as well as the edible pork prod ucts derived from those animals. (c) Process-verification testing. A slaughter facility processing certified swine is responsible for performing process-verification testing to deter mine the Trichinella spp. infection sta tus of certified swine under its control as follows: (1) Validated tests. Process verification testing must be performed by using a validated test. When testing involves meat, the sample used for such testing must be at least 20 grams. 4 (2) Laboratory approval. Process verification testing must be performed in an approved laboratory that has been approved for trichinae testing by the Agricultural Marketing Service (AMS). 5 The approved laboratory may be maintained and operated by the slaughter facility or by another busi ness entity either on the premises of the slaughter facility or at another lo cation. Laboratory staff performing process-verification testing must be ac credited by AMS to perform this pro gram function. For purposes of quality assurance, all laboratory staff ap proved to perform process-verification testing will receive periodic pro ficiency test panels from AMS that must be analyzed correctly in order to maintain their approval status. (3) Testing sample size and frequency. Process-verification testing must meet the following minimum requirements relating to sample size and frequency: (i) Slaughter facility representatives shall determine the yearly processing capacity of the slaughter facility for the next 12 months. Officials may use the processing capacity over the pre vious 12 months if this period is rep resentative of a typical processing year. (ii) Slaughter facility representatives shall estimate the percentage of swine processed that are likely to come from certified production sites considering all swine expected to be processed at the slaughter facility during the se lected 12-month period. Swine that come from certified production sites are considered the eligible population to be sampled. (iii) Slaughter facility representa tives shall use the Trichinae Certifi cation Slaughter Facility Sample Size Determination Table on the Internet at http://www.aphis.usda.gov/vs/trichinae to find the number of samples to collect from the population of swine from cer tified production sites. 6 If the eligible population is not listed in that table, the next largest number will be used to determine the number of samples to collect. Select the number of samples to collect from the column on that table that reflects a 99 percent con fidence level of detecting a positive carcass in a population with a preva lence rate of 0.013 percent. The number selected from the table will be the total number of samples that slaughter facility representatives must collect and test per year and per month during the selected 12-month period. (iv) For each sample collected, slaughter facility representatives must maintain the identity of the sample using the PIN of the certified produc tion site that was the source of the swine from which the sample was taken. (v) FSIS program employees at the slaughter facility will review and verify that an adequate number of sam ples have been collected and that prop er frequency of collection is main tained. FSIS will report this informa tion to APHIS. (vi) AMS representatives will verify through a laboratory approval audit that the laboratory performing proc ess-verification testing is correctly fol lowing written procedures relating to the receipt, handling, identification, VerDate Sep<11>2014 13:56 Feb 14, 2018 Jkt 244028 PO 00000 Frm 00991 Fmt 8010 Sfmt 8010 Q:\09\9V1.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 982 9 CFR Ch. I (1–1–18 Edition) § 149.6 and testing of samples. These written procedures must be maintained by the laboratory in a quality assurance man ual, as provided in paragraph (c)(6) of this section. In addition, a laboratory that performs process-verification test ing at a location other than the slaugh ter facility must include a declaration of methodology used to test samples when providing test results. (vii) The APHIS Administrator may, at APHIS’ expense, periodically re quest that testing be performed on swine brought to the slaughter facility from specific certified production sites. Requests to test swine from specific certified production sites will count to wards the slaughter facility’s total monthly testing requirement. (4) Results of testing. (i) The results of all process-verification testing relating to certified swine handled at the slaughter facility must be retained in a separate file or notebook as written records at the slaughter facility and must be readily available for inspec tion by FSIS program employees. (ii) FSIS will report to APHIS the re sults of all process-verification testing. (iii) In the event of a positive test re sult, the slaughter facility representa tive must notify the FSIS program em ployee designated by the FSIS Admin istrator immediately, who in turn will report the PIN of the certified produc tion site that was the source of the swine from which the sample was taken and the test results of the af fected sample to the respective APHIS area office. The following sequence of events must take place following a positive test result: (A) If a test sample yields a positive test result based on the digestion method, the certified production site that was the source of the swine from which the sample was taken will be de certified. (B) If a test sample yields a positive test result based on an ELISA method and is confirmed positive by further testing using the digestion method, the certified production site that was the source of the swine from which the sample was taken will be decertified. (C) If a test sample yields a positive test result based on an ELISA method, but is not confirmed positive by fur ther testing using the digestion meth od, then the certified production site that was the source of the swine from which the sample was taken will be in vestigated by APHIS. (1) The investigation may include a spot audit of the affected site. Further testing of animals or carcasses from the affected site also may be performed as part of the investigation. This inves tigation would determine if the produc tion facility has sufficient safeguards and is following good production prac tices. (2) While the affected site is under in vestigation, its program status as a certified production site will be sus pended. While the site is under suspen sion, the producer must continue to ad here to all of the required good produc tion practices and other recordkeeping and program requirements provided in this part. During this suspension, swine at the site may be sent to slaughter; however, swine from the suspended site cannot be identified as product from a certified production site. The Adminis trator will determine the program sta tus of the affected site within 30 days of the initiation of the suspension. (3) A finding that risk factors are in adequately addressed in the site inves tigation or the finding of additional positive test results based on samples from animals or carcasses from the af fected site will be grounds for APHIS decertification of the site. (5) Slaughter facility recordkeeping. (i) All slaughter facilities that receive certified swine must maintain records relating to such animals, including the number of certified swine processed, the source of the certified swine, in cluding the PIN of the certified produc tion site from which the swine came from, and all test results relating to process-verification testing. Records relating to certified swine must be re tained at the slaughter facility for a period of at least 3 years following the processing of such animals. (ii) All slaughter facilities must have documented procedures on how cer tified swine under its control, and edi ble pork products derived from cer tified swine, will remain segregated from swine and edible pork products from noncertified sites throughout re ceiving, handling, and processing at the facility, as well as while awaiting VerDate Sep<11>2014 13:56 Feb 14, 2018 Jkt 244028 PO 00000 Frm 00992 Fmt 8010 Sfmt 8010 Q:\09\9V1.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 983 Animal and Plant Health Inspection Service, USDA § 149.7 shipment from the facility. The slaugh ter facility must also have documented procedures for maintaining the iden tity of the certified swine or pork with respect to the certified production site from which it came. (iii) All such records and other docu mentation required to be maintained by slaughter facilities under this part must be readily available for inspec tion by FSIS program employees. (6) Approved laboratory recordkeeping. Approved laboratories must have writ ten procedures that specify standards for sample size, sample handling, sam ple identification, and sample test methods used in process-verification testing. All such written procedures must be maintained in a laboratory quality assurance manual specifically for this program, or as a separate sec tion of an existing laboratory quality assurance manual, and must be re tained at the approved laboratory throughout the time the approved lab oratory is performing process verification testing under this pro gram. All such written procedures re lating to process-verification testing must be readily available for inspec tion by FSIS program employees or AMS representatives. (7) Slaughter facility overall responsi bility for process-verification testing. The slaughter facility is responsible for ob taining testable samples and for ensur ing that the correct number of testable samples are sent to the testing labora tory. Once the slaughtering facility re ceives the test results, it is responsible for reporting those results in its facil ity trichinae testing record. Moreover, the slaughter facility is responsible for ensuring that process-verification test ing is carried out in accordance with this part, including the reporting of test results, regardless of whether it is performed at the slaughter facility or another location, and regardless of whether the testing is performed by slaughter facility personnel or other persons. § 149.7 Recordkeeping at site. (a) Stage I enrolled sites, Stage II or Stage III certified sites, and any site that has been suspended or voluntarily decertified must maintain the fol lowing program records: Animal dis posal plan, animal movement record, feed mill quality assurance affidavit (if applicable), and rodent control log book. All such records must be readily available for inspection at the pork production site at the time of an audit by a QAV or QVMO, or by other APHIS representatives during normal business hours. (1) Animal disposal plan. The animal disposal plan must meet the following minimum requirements: (i) It must provide for the removal of all dead swine or swine remains from swine pens immediately upon detec tion. Inspections for purposes of detect ing dead animals must occur at least once every 24 hours. (ii) It must specify how often and at what intervals the swine pens are ob served each day. (iii) It must provide for the proper storage of dead swine or swine remains in accordance with local, State, and Federal laws and regulations. If the carcass storage facility or composting facility is located on the site, then the animal disposal plan must provide for a storage or composting facility that precludes rodent or wildlife contact with dead swine or swine remains being stored or composted. (iv) It must provide for the disposal of swine and other mammals by ren dering, incineration, composting, bur ial, or other means, as allowed by and in accordance with local, State, and Federal laws and regulations. For sites that use rendering services, the animal disposal plan also must include the name, address, and phone number of the renderer. (v) It must be updated as animal dis posal practices are changed at the site. (vi) It must be signed and dated by the producer, as well as the caretaker of the site (if the caretaker is a dif ferent person than the producer). (vii) It may be valid for a period no longer than 2 years after the date of signature by the producer and (if appli cable) the site caretaker. (2) Animal movement record. The ani mal movement record must meet the following minimum requirements: (i) It must be filled out completely and properly, accounting for the move ment of all non-breeding swine into and from the pork production site. VerDate Sep<11>2014 13:56 Feb 14, 2018 Jkt 244028 PO 00000 Frm 00993 Fmt 8010 Sfmt 8010 Q:\09\9V1.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 984 9 CFR Ch. I (1–1–18 Edition) § 149.8 (ii) In the case of non-breeding swine coming into the site, it must include the date and number of arriving ani mals, as well as the PIN of the certified production site where the animals originated, or alternatively, if the swine are less than 5 weeks of age and originated from a noncertified site, the name and full address of the noncer tified site where the animals origi nated. The animal movement record must clearly document that all non breeding swine 5 weeks of age or older arriving at the site originated from an other certified production site. (iii) In the case of non-breeding swine leaving the site, it must include the date and number of departing animals, and their destination. (iv) It must document the number of dead non-breeding swine that are re moved from the site, as well as the number of dead non-breeding swine that are buried or composted at the site, if swine burial or composting is permitted in that State or locality. (v) All entries to the animal move ment record must be signed or initialed and dated by the producer or other site caretaker making the entry. (3) Rodent control logbook. The rodent control logbook, which may include records from a pest control operator, must meet the following minimum re quirements: (i) It must include a rodent control diagram for the site indicating the lo cation of all rodent bait stations and rodent traps at the site. The diagram must be updated whenever bait sta tions are added, moved, or removed. (ii) It must document the number of rodent traps set (if applicable), the number of new rodent bait stations set, and how often bait is refreshed. (iii) It must document the disposal method for all unused bait that is re placed. (iv) It must document the brand name and active ingredient of bait, which must be EPA-registered and ap plied according to its label, as well as the quantity of bait used (number of pounds). (v) If possible, it should document the number of rodents caught or killed and indicate how many were rats. (vi) If possible, it should document the number of rats sighted monthly. (vii) All entries to the rodent control logbook must be signed or initialed, as well as dated by the producer or other site caretaker making the entry. It must be updated at least monthly. (4) Feed mill quality assurance affi davit. The feed mill quality assurance affidavit, to be used in conjunction with feed or feed ingredients delivered to the pork production site, must meet the following minimum requirements: (i) It must include the name of the producer and the identity of the site, including the PIN if it has been issued, and the site address, as well as the name and address of the feed mill and the name and title of the feed mill rep resentative. (ii) It must provide information that the feed mill is following good manu facturing practices, and further speci fy, as evidence of these good manufac turing practices, the following: (A) That the feed mill has a rodent control system that is maintained by the feed mill itself or by a pest control firm (include name and address of pest control firm). (B) The frequency with which such rodent control system is maintained (i.e., on a weekly basis, etc.); and (C) That the feed mill maintains records of pest management practices or has records generated by a pest con trol operator, which must be made available to the producer upon request. (iii) It must be signed by the feed mill representative and by the pro ducer or the producer’s designated rep resentative, to remain in effect for a period of 2 years. (b) All such records and other docu mentation required under this section must be retained at the pork produc tion site for a period of 2 years. (c) All such records and other docu mentation required under this section must be readily available for inspec tion at the pork production site at the time of an audit by a QAV or QVMO, or by other APHIS representatives during normal business hours. (Approved by the Office of Management and Budget under control number 0579–0323) § 149.8 Program fees and charges. (a) Site audit. If a QVMO performs the site audit, then the producer will pay the QVMO at the time the site audit is VerDate Sep<11>2014 13:56 Feb 14, 2018 Jkt 244028 PO 00000 Frm 00994 Fmt 8010 Sfmt 8010 Q:\09\9V1.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 985 Animal and Plant Health Inspection Service, USDA § 149.9 performed in accordance with the rate and other conditions set by the QVMO’s governmental employer. Fur ther, if the QVMO who performs the site audit is employed by APHIS, then the producer will pay APHIS for this service at the hourly rate listed in table 1 for each employee required to perform the service. If the APHIS-em ployed QVMO performs the site audit on a Sunday, on a holiday, or at any time outside the normal tour of duty of that employee, then the producer will pay APHIS for this service at the hour ly rate listed in table 2 for each em ployee required to perform the service. Payment to APHIS for the services of an APHIS-employed QVMO, by cer tified check or U.S. money order, must be remitted to the QVMO at the time the site audit is performed. TABLE 1—RATES FOR SERVICES OF QVMO Hourly rate: Per hour ......................... $84.00 Per quarter hour ............. 21.00 Per service minimum fee .............. 25.00 TABLE 2—OVERTIME RATES FOR SERVICES OF QVMO (OUTSIDE THE EMPLOYEE’S NORMAL TOUR OF DUTY) Premium hourly rate Monday through Saturday and holidays: Per hour ......................... $100.00 TABLE 2—OVERTIME RATES FOR SERVICES OF QVMO (OUTSIDE THE EMPLOYEE’S NORMAL TOUR OF DUTY)—Continued Per quarter hour ............. 25.00 Premium hourly rate for Sundays: Per hour ......................... 112.00 Per quarter hour ............. 28.00 (b) Program fee. The producer must pay APHIS a program fee at the time of each site audit in the amount of $51 to cover APHIS’ administrative costs in processing the audit and operating the program. This program fee, payable to APHIS by certified check or U.S. money order, is due at the time of sub mitting the completed site audit form for APHIS evaluation. (c) A producer will not be charged for the cost of having a spot audit per formed at the pork production site. § 149.9 Pilot program sites. Pork production sites participating in an APHIS-approved trichinae pilot program at the time of implementation of the Trichinae Certification Program on November 10, 2008 will maintain their same program status as either a Stage I enrolled, Stage II certified, or Stage III certified site, as well as their same program anniversary date for purposes of completing a site audit and submitting the completed audit form and payment. VerDate Sep<11>2014 13:56 Feb 14, 2018 Jkt 244028 PO 00000 Frm 00995 Fmt 8010 Sfmt 8010 Q:\09\9V1.TXT 31kp a yn e o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B