Words used in this part in the singular form shall be deemed to import the plural, and vice versa, as the case may demand. Except where the context otherwise requires, for the purposes of this part the following terms shall be construed, respectively, to mean:

Administrator. The Administrator, Animal and Plant Health Inspection Service, or any person authorized to act for the Administrator.

Affiliated flockowner. A flockowner who is participating in the Plan through an agreement with a participating hatchery.

Animal and Plant Health Inspection Service. The Animal and Plant Health Inspection Service of the U.S. Department of Agriculture.

Authorized agent. Any person designated under § 145.11(a) to collect official samples for submission to an authorized 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 accordance 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. Avian influenza is defined as an infection of poultry caused by any influenza A virus of the H5 or H7 subtypes or by any influenza A virus with an intravenous pathogenicity index (IVPI) greater than 1.2 (or as an alternative at least 75 percent mortality).

Baby poultry. Newly hatched poultry (chicks, poults, ducklings, goslings, keets, etc.).

Colon bacilli. For the purpose of this chapter, those organisms which are gram negative, non spore-forming bacilli, which ferment lactose with gas formation, and serve as an index of fecal contamination.

Dealer. An individual or business that deals in commerce in hatching eggs, newly-hatched poultry, and started poultry obtained from breeding flocks and hatcheries. This does not include an individual or business that deals in commerce in buying and selling poultry for slaughter only.

Department. The U.S. Department of Agriculture.

Domesticated. Propagated and maintained under the control of a person.

Equivalent or equivalent requirements. Requirements which are equal to or exceed the program, conditions, criteria, or classifications with which they are compared, as determined by the Official State Agency and with the concurrence of the Service.

Exposed (Exposure). Contact with birds, equipment, personnel, supplies, or any article infected with, or contaminated by, communicable poultry disease organisms.

Flock—(1) As applied to breeding. All poultry of one kind of mating (breed and variety or combination of stocks) and of one classification on one farm;

(2) As applied to disease control. All of the poultry on one farm except that, at the discretion of the Official State Agency, any group of poultry which is segregated from another group and has been so segregated for a period of at least 21 days may be considered as a separate flock.

Fluff sample. Feathers, shell membrane, and other debris resulting from the hatching of poultry.

Fowl typhoid or typhoid. A disease of poultry caused by Salmonella gallinarum.

Franchise breeder. A breeder who normally sells products under a specific strain or trade name and who authorizes other hatcheries to produce and sell products under this same strain or trade name.

Franchise hatchery. A hatchery which has been authorized by a franchise breeder to produce and sell products under the breeder's strain or trade name.

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 pathogenicity 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 intravenously, or an infection with influenza A viruses of H5 or H7 subtype with a cleavage site that is not consistent 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 poultry.

Independent flock. A flock that produces hatching eggs and that has no ownership affiliation with a specific hatchery.

Infected flock. A flock in which an authorized laboratory has discovered one or more birds infected with a communicable poultry disease for which a program has been established under the Plan.

Midlay. Approximately 2-3 months after a flock begins to lay or after a molted flock is put back into production.

Multiplier breeding flock. A flock that is intended for the production of hatching eggs used for the purpose of producing progeny for commercial egg or meat production or for other nonbreeding purposes.

Newcastle disease. Newcastle disease (ND) is defined as an infection of poultry caused by Newcastle disease virus (NDV), which is an avian paramyxovirus serotype 1 (APMV-1) that meets one of the following criteria for virulence:

(1) The virus has an intracerebral pathogenicity index (ICPI) in day-old chicks (Gallusgallus) of 0.7 or greater; or

(2) Multiple basic amino acids have been demonstrated in the virus (either directly or by deduction) at the C-terminus of the F2 protein and phenylalanine at residue 117, which is the N-terminus of the F1 protein. The term 'multiple basic amino acids' refers to at least three arginine or lysine residues between residues 113 and 116. Failure to demonstrate the characteristic pattern of amino acid residues as described in the preceding sentences would require characterization of the isolated virus by an ICPI test.

NPIP Program Standards. A document that contains tests and sanitation procedures approved by the Administrator in accordance with § 147.53 of this subchapter for use under this subchapter. This document may be obtained from the National Poultry Improvement Plan (NPIP) website at http://www.poultryimprovement.org/ or by writing to the Service at National Poultry Improvement Plan, APHIS, USDA, 1506 Klondike Road, Suite 101, Conyers, GA 30094.

NPIP Technical Committee. A committee made up of technical experts on poultry health, biosecurity, surveillance, and diagnostics. The committee consists of representatives from the poultry and egg industries, universities, and State and Federal governments and is appointed by the Senior Coordinator and approved by the General Conference Committee. The NPIP Technical Committee is divided into three subcommittees (Mycoplasma, Salmonella, and Avian Influenza). NPIP Technical Committee Members may serve on one, two, or all three subcommittees. The committee will evaluate proposed changes to the Provisions and Program Standards of the Plan which include, but are not limited to, tests and sanitation procedures, and provide recommendations to the Delegates of the National Plan Conference as to whether they are scientifically or technically sound.

Official State Agency. The State authority recognized by the Department to cooperate in the administration of the Plan.

Official supervision—(1) As applied to Plan programs. The direction, inspection, and critical evaluation by the Official State Agency of compliance with the provisions of the Plan;

(2) As applied to non-Plan but equivalent State poultry improvement programs. The direction, inspection, and critical evaluation by an officer or agency of a State government, of compliance with a publicly announced State poultry improvement program.

Person. A natural person, firm, or corporation.

Plan. The provisions of the National Poultry Improvement Plan contained in this part.

Poultry. Domesticated fowl, including chickens, turkeys, ostriches, emus, rheas, cassowaries, waterfowl, and game birds, except doves and pigeons, which are bred for the primary purpose of producing eggs or meat.

Primary breeding flock. A flock composed of one or more generations that is maintained for the purpose of establishing, continuing, or improving parent lines.

Products. Poultry breeding stock and hatching eggs, baby poultry, and started poultry.

Program. Management, sanitation, testing, and monitoring procedures which, if complied with, will qualify, and maintain qualification for, designation of a flock, products produced from the flock, or a state by an official Plan classification and illustrative design, as described in § 145.10 of this part.

Public exhibition. A public show of poultry.

Pullorum disease or pullorum. A disease of poultry caused by Salmonella pullorum.

Reactor. A bird that has a positive reaction to a test, required or recommended in this part or in accordance with part 147 of this subchapter, for any poultry disease for which a program has been established under the Plan.

Salmonella. Any bacteria belonging to the genus Salmonella, including the arizona group.

Sanitize. To treat with a product which is registered by the Environmental Protection Agency as germicidal, fungicidal, pseudomonocidal, or tuberculocidal, in accordance with the specifications for use as shown on the label of each product. The Official State Agency, with the concurrence of the Service, shall approve each product or procedure according to its specified usage.

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 conducting the Plan Conference;

(4) Reviewing NPIP authorized laboratories as described in § 147.52;

(5) Coordinating the State administration of the NPIP through periodic reviews of the administrative procedures of the Official State Agencies, according to the applicable provisions of the Plan and the Memorandum of Understanding;

(6) Coordinating rulemaking to incorporate the proposed changes of the provisions approved at the Plan conference into the regulations in parts 145, 146, and 147 of this subchapter;

(7) Directing the production of official NPIP publications;

(8) Proposing an annual budget for plan activities and the General Conference Committee; and

(9) Providing overall administration of the NPIP.

Service. The Animal and Plant Health Inspection Service, Veterinary Services, of the Department.

Serial. The total quantity of completed product which has been thoroughly mixed in a single container and identified by a serial number.

Sexual maturity. The average age at which a species of poultry is biologically capable of reproduction.

Started poultry. Young poultry (chicks, pullets, cockerels, capons, poults, ducklings, goslings, keets, etc.) that have been fed and watered and are less than 6 months of age.

State. Any State, the District of Columbia, or Puerto Rico.

State Inspector. Any person employed or authorized under § 145.11(b) to perform functions under this part.

Stock. A term used to identify the progeny of a specific breeding combination within a species of poultry. These breeding combinations may include pure strains, strain crosses, breed crosses, or combinations thereof.

Strain. Poultry breeding stock bearing a given name produced by a breeder through at least five generations of closed flock breeding.

Succeeding flock. A flock brought onto a premises during the 12 months following removal of an infected flock.

Suspect flock. A flock shall be considered, for the purposes of the Plan, to be a suspect flock if any evidence exists that it has been exposed to a communicable poultry disease.

Trade name or number. A name or number compatible with State and Federal laws and regulations applied to a specified stock or product thereof.

(a) The Department cooperates through a Memorandum of Understanding with Official State Agencies in the administration of the Plan. In the Memorandum of Understanding, the Official State Agency must designate a contact representative to serve as a liaison between the Service and the Official State Agency.

(b) The administrative procedures and decisions of the Official State Agency are subject to review by the Service. The Official State Agency shall carry out the administration of the Plan within the State according to the applicable provisions of the Plan and the Memorandum of Understanding.

(c) An Official State Agency may accept for participation an affiliated flock located in another State under a mutual understanding and agreement, in writing, between the two Official State Agencies regarding conditions of participation and supervision.

(d) The Official State Agency of any State may, except as limited by § 145.3(e), adopt regulations applicable to the administration of the Plan in such State further defining the provisions of the Plan or establishing higher standards compatible with the Plan.

(e) An authorized laboratory of the National Poultry Improvement Plan will conduct tests in accordance with part 147 of this subchapter when determining the status of a participating flock with respect to an official Plan classification.

(a) The National Poultry Improvement Plan is a cooperative Federal-State-Industry program through which new or existing diagnostic technology can be effectively applied to improve poultry and poultry products by controlling or eliminating specific poultry diseases. The Plan consists of programs that identify States, flocks, hatcheries, dealers, and slaughter plants that meet specific disease control standards specified in the Plan. Participants shall maintain records to demonstrate that they adhere to the disease control programs in which they participate.

(b) Any person producing or dealing in products may participate in the Plan when he has demonstrated, to the satisfaction of the Official State Agency, that his facilities, personnel, and practices are adequate for carrying out the applicable provisions of the Plan, and has signed an agreement with the Official State Agency to comply with the general and the applicable specific provisions of the Plan and any regulations of the Official State Agency under § 145.2. Affiliated flockowners may participate without signing an agreement with the Official State Agency.

(c) Each participant shall comply with the Plan throughout the operating year of the Official State Agency, or until released by such Agency.

(d) A participant in any State shall participate with all of his poultry hatching egg supply flocks and hatchery operations within such State. The participant shall report to the Official State Agency on VS Form 9-2 (formerly NPIP Form 3B) or through other appropriate means each breeding flock before the birds reach 24 weeks of age or, in the case of ostriches, emus, rheas, and cassowaries, before the birds reach 20 months of age. This report will include:

(1) Name and address of flockowner;

(2) Flock location and designation;

(3) Type: Primary or Multiplier;

(4) Breed, variety, strain, or trade name of stock;

(5) Source of males;

(6) Source of females;

(7) Number of birds in the flock; and

(8) Intended classification of flock.

(e) To ensure that Plan diseases are not spread, flocks must be qualified for their intended Plan classifications before being moved into breeder production facilities.

(f) No person shall be compelled by the Official State Agency to qualify products for any of the other classifications described in § 145.10 as a condition of qualification for the U.S. Pullorum-Typhoid Clean classification.

(g) Participation in the Plan shall entitle the participant to use the Plan emblem reproduced below:

(a) Records of purchases and sales and the identity of products handled shall be maintained in a manner satisfactory to the Official State Agency.

(b) Products, records of sales and purchase of products, and material used to advertise products shall be subject to inspection by the Official State Agency at any time.

(c) Advertising must be in accordance with the Plan, and applicable rules and regulations of the Official State Agency and the Federal Trade Commission. A participant advertising products as being of any official classification may include in his advertising reference to associated or franchised hatcheries only when such hatcheries produce the same kind of products of the same classification.

(d) Except as provided by this paragraph, participants in the Plan may not buy or receive products for any purpose from nonparticipants unless they are part of an equivalent program, as determined by the Official State Agency. Participants in the Plan may buy or receive products from flocks that are neither participants nor part of an equivalent program, for use in breeding flocks or for experimental purposes, under the following conditions only:

(1) With the permission of the Official State Agency and the concurrence of the Service; and

(2) By segregation of all birds before introduction into the breeding flock. Upon reaching sexual maturity, the segregated birds must be tested and found negative for pullorum-typhoid and any other disease for which the flock into which the birds are being introduced holds a disease classification. The Official State Agency may require a second test at its discretion.

(e) Each participant shall be assigned a permanent approval number by the Service. This number, prefaced by the numerical code of the State, will be the official approval number of the participant and may be used on each certificate, invoice, shipping label, or other document used by the participant in the sale of his products. Each Official State Agency which requires an approval or permit number for out-of-State participants to ship into its State should honor this number. The approval number shall be withdrawn when the participant no longer qualifies for participation in the Plan.

(a) Poultry equipment, and poultry houses and the land in the immediate vicinity thereof, shall be kept in sanitary condition in accordance with part 147 of this subchapter. The participating flock, its eggs, and all equipment used in connection with the flock shall be separated from nonparticipating flocks, in a manner acceptable to the Official State Agency.

(b) All flocks shall consist of healthy, normal individuals characteristic of the breed, variety, cross, or other combination which they are stated to represent.

(c) A flock shall be deemed to be a participating flock at any time only if it has qualified for the U.S. Pullorum-Typhoid Clean classification, as prescribed in Subparts B, C, D, E, F, G, H, 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.

(a) Hatcheries must be kept in sanitary condition, acceptable to the Official State Agency. The sanitary procedures outlined in the NPIP Program Standards, or other procedures approved by the Administrator in accordance with § 147.53(d), will be considered as a guide in determining compliance with this provision. The minimum requirements with respect to sanitation include the following:

(1) Egg room walls, ceilings, floors, air filters, drains, and humidifiers should be cleaned and disinfected at least two times per week. Cleaning and disinfection procedures should be in accordance with part 147 of this subchapter.

(2) Incubator room walls, ceilings, floors, doors, fan grills, vents, and ducts should be cleaned and disinfected after each set or transfer. Incubator rooms should not be used for storage. Plenums should be cleaned at least weekly. Egg trays and buggies should be cleaned and disinfected after each transfer. Cleaning and disinfection procedures should be in accordance with part 147 of this subchapter.

(3) Hatcher walls, ceilings, floors, doors, fans, vents, and ducts should be cleaned and disinfected after each hatch. Hatcher rooms should be cleaned and disinfected after each hatch and should not be used for storage. Plenums should be cleaned after each hatch. Cleaning and disinfection procedures should be in accordance with part 147 of this subchapter.

(4) Chick/poult processing equipment and rooms should be thoroughly cleaned and disinfected after each hatch. Chick/poult boxes should be cleaned and disinfected before being reused. Vaccination equipment should be cleaned and disinfected after each use. Cleaning and disinfection procedures should be in accordance with part 147 of this subchapter.

(5) Hatchery residue, such as chick/poult down, eggshells, infertile eggs, and dead germs, should be disposed of promptly and in a manner satisfactory to the Official State Agency.

(6) The entire hatchery should be kept in a neat, orderly condition and cleaned and disinfected after each hatch.

(7) Effective insect and rodent control programs should be implemented.

(b) A hatchery that keeps started poultry must keep such poultry separated from the incubator room in a manner satisfactory to the Official State Agency.

(c) All baby and started poultry offered for sale under Plan terminology should be normal and typical of the breed, variety, cross, or other combination represented.

(d) Eggs incubated should be sound in shell, typical for the breed, variety, strain, or cross thereof and reasonably uniform in shape. Hatching eggs should be trayed and the baby poultry boxed with a view to uniformity of size.

(e) Any nutritive material provided to baby poultry must be free of the avian pathogens that are officially represented in the Plan disease classifications listed in § 145.10.

(f) If a person is responsibly connected with more than one hatchery, all of such hatcheries must participate in the Plan if any of them participate. A person is deemed to be responsibly connected with a hatchery if he or she is a partner, officer, director, holder, owner of 10 percent or more of the voting stock, or an employee in a managerial or executive capacity.

Dealers in hatching eggs, newly hatched poultry, or started poultry shall comply with the provisions in this part (within the NPIP Program Standards document, Program Standard C applies to hatcheries; alternatives to the program standards may also be approved by the Administrator under § 147.53 of this subchapter).

(a) The official classification terms defined in §§ 145.9 and 145.10 and the various designs illustrative of the official classifications reproduced in § 145.10 may be used only by participants and to describe products that have met all the specific requirements of such classifications.

(b) Products produced under the Plan shall lose their identity under Plan terminology when they are purchased for resale by or consigned to nonparticipants.

(c) Participating flocks, their eggs, and the baby and started poultry produced from them may be designated by their strain or trade name. When a breeder's trade name or strain designation is used, the participant shall be able by records to substantiate that the products so designated are from flocks that are composed of either birds hatched from eggs produced under the direct supervision of the breeder of such strain, or stock multiplied by persons designated and so reported by the breeder to each Official State Agency concerned.

Participating hatcheries and dealers shall be designated as “National Plan Hatchery” and “National Plan Dealer”, respectively. All Official State Agencies shall be notified by the Service of additions, withdrawals, and changes in classification.

Participating flocks, products produced from them, and States that have met the requirements of a classification in this part may be designated by the corresponding illustrative design in this section.

(a) [Reserved]

(b) U.S. Pullorum-Typhoid Clean. (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)).

(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).)

(i) U.S.M. Gallisepticum Clean State, Turkeys. (See § 145.44(c).)

(j) U.S. M. Gallisepticum Clean State, Meat-Type Chickens. (See § 145.34(b).)

(k) U.S. Sanitation Monitored, Turkeys. (See § 145.43(f).)

(l) [Reserved]

(m) U.S. S. Enteritidis Clean. (See §§ 145.23(d), 145.73(d), and 145.83(e).)

(n) U.S. M. Synoviae Clean State, Turkeys. (See § 145.44(d).)

(o) U.S. Salmonella Monitored. (See §§ 145.53(f), 145.73(g), 145.83(f), and 145.93(d).)

(p) U.S. M. Gallisepticum Monitored. (See § 145.33(j).)

(q) U.S. M. Synoviae Monitored. (See § 145.33(k).)

(r) U.S. Avian Influenza Clean. (See §§ 145.23(h), 145.33(l), 145.63(b), 145.73(f), and 145.83(g).)

(s) U.S. M. Meleagridis Clean State, Turkeys. (See § 145.44(e).)

(t) U.S. H5/H7 Avian Influenza Clean. (See §§ 145.43(g), 145.53(e), and 145.93(c).)

(a) The Official State Agency may designate qualified persons as Authorized Agents to do the sample collecting provided for in § 145.14 and may designate qualified persons as Authorized Testing Agents to do the sample collecting and blood testing provided for in § 145.14.

(b) The Official State Agency shall employ or authorize qualified persons as State Inspectors to perform the qualification testing of participating flocks, and to perform the official inspections necessary to verify compliance with the requirements of the Plan.

(c) Authorities issued under the provisions of this section shall be subject to cancellation by the official State agency on the grounds of incompetence or failure to comply with the provisions of the Plan or regulations of the official State agency. Such actions shall not be taken until a thorough investigation has been made by the official State agency and the authorized person has been given notice of the proposed action and the basis therefor and an opportunity to present his views.

(a) Each participating hatchery shall be audited at least one time annually or a sufficient number of times each year to satisfy the Official State Agency that the operations of the hatchery are in compliance with the provisions of the Plan.

(b) The records of all flocks maintained primarily for production of hatching eggs shall be made available to and examined annually by a State Inspector. Records shall include VS Form 9-2, “Flock Selecting and Testing Report”; VS Form 9-3, “Report of Sales of Hatching Eggs, Chicks, and Poults”; set and hatch records; egg receipts; and egg/chick orders or invoices. Records shall be maintained for 3 years. On-site inspections of flocks and premises will be conducted if the State Inspector determines that a breach of sanitation, blood testing, or other provisions has occurred for Plan programs for which the flocks have or are being qualified.

Participants in the Plan, who after investigation by the Official State Agency or its representative, are notified in writing of their apparent noncompliance with the Plan provisions or regulations of the Official State Agency, shall be afforded a reasonable time, as specified by the Official State Agency, within which to demonstrate or achieve compliance. If compliance is not demonstrated or achieved within the specified time, the Official State Agency may debar the participant from further participation in the Plan for such period, or indefinitely, as the Agency may deem appropriate. The debarred participant shall be afforded notice of the bases for the debarment and opportunity to present his views with respect to the debarment in accordance with procedures adopted by the Official State Agency. The Official State Agency shall thereupon decide whether the debarment order shall continue in effect. Such decision shall be final unless the debarred participant, within 30 days after the issuance of the debarment order, requests the Administrator to determine the eligibility of the debarred participant for participation in the Plan. In such event the Administrator shall determine the matter de novo in accordance with the rules of practice in 7 CFR part 50, which are hereby made applicable to proceedings before the Administrator under this section. The definitions in 7 CFR 50.10 and the following definitions shall apply with respect to terms used in such rules of practice:

(a) Administrator means the Administrator, Animal and Plant Health Inspection Service of the U.S. Department of Agriculture or any officer or employee to whom authority has heretofore been delegated or to whom authority may hereafter be delegated to act in his stead.

Poultry must be more than 4 months of age when tested for an official classification: Provided, That turkey candidates under subpart D of this part may be tested at more than 12 weeks of age; game bird candidates under subpart 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 official tests shall be collected by an Authorized Agent, Authorized Testing Agent, or State Inspector and tested by an authorized laboratory, except that the stained antigen, rapid whole-blood test for pullorum-typhoid may be conducted by an Authorized Testing Agent or State Inspector. For Plan programs in which a representative sample may be tested in lieu of an entire flock, except the ostrich, emu, rhea, and cassowary program in § 145.63(a), the minimum number tested shall be 30 birds per house, unless otherwise specified within the Plan program, with at least 1 bird taken from each pen and unit in the house. The ratio of male to female birds in representative samples of birds from meat-type chicken, waterfowl, exhibition poultry, and game bird flocks must be the same as the ratio of male to female birds in the flock. In houses containing fewer than 30 birds other than ostriches, emus, rheas, and cassowaries, all birds in the house must be tested, unless otherwise specified within the Plan program.

(a) For Pullorum-Typhoid. (1) The official blood tests for pullorum-typhoid shall be the standard tube agglutination test, the microagglutination test, the enzyme-linked immunosorbent assay test (ELISA), or the rapid serum test for all poultry; and the stained antigen, rapid whole-blood test for all poultry except turkeys. Official blood tests must be conducted in accordance with part 147 of this subchapter or according 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 thereafter as long as antigen from that serial continues to be made available for use. All microtest antigens and enzyme-linked immunosorbent assay reagents shall also be approved by the Department. 1

(2) [Reserved]

(3) There shall be an interval of at least 21 days between any official blood test and any previous test with pullorum-typhoid antigen.

(4) [Reserved]

(5) The official blood test shall include the testing of a sample of blood from each bird in the flock: Provided, That under specified conditions (see applicable provisions of §§ 145.23, 145.33, 145.43, 145.53, 145.63, 145.73, 145.83, and 145.93) the testing of a portion or sample of the birds may be used in lieu of testing each bird.

(6) Poultry from flocks undergoing qualification testing for participation in the Plan that have a positive reaction to an official blood test named in paragraph (a)(1) of this section shall be evaluated for pullorum-typhoid as follows:

(i) Serum samples that react on rapid serum test or enzyme-labeled immunosorbent assay test (ELISA), or blood from birds that react on the stained antigen, rapid whole-blood test for all birds except turkeys, shall be tested with either the standard tube agglutination test or the microagglutination test.

(ii) Reactors to the standard tube agglutination test (in dilutions of 1:50 or greater) or the microagglutination test (in dilutions of 1:40 or greater) shall be submitted to an authorized laboratory for bacteriological examination. If there are more than four reactors in a flock, a minimum of four reactors shall be submitted to the authorized laboratory; if the flock has four or fewer reactors, all of the reactors must be submitted. Bacteriological examination must be conducted in accordance with part 147 of this subchapter. When reactors are submitted to the authorized laboratory within 10 days of the date of reading an official blood test named in paragraph (a)(6)(i) of this section, and the bacteriological examination fails to demonstrate pullorum-typhoid infection, the Official State Agency shall presume that the flock has no pullorum-typhoid reactors.

(iii) If a flock owner does not wish to submit reactors for bacteriological examination, then the reactors shall be isolated and retested within 30 days using an official blood test named in paragraph (a)(1) of this section. If this retest is positive, additional examination of the reactors and flock will be performed in accordance with paragraph (a)(6)(ii) of this section. During this 30-day period, the flock must be maintained under a security system, specified or approved by the Official State Agency, that will prevent physical contact with other birds and assure that personnel, equipment, and supplies that could be a source of pullorum-typhoid spread are sanitized.

(7) When S. pullorum or S. gallinarum organisms are isolated by an authorized laboratory from baby poultry, or from fluff samples produced by hatching eggs, the infected flock shall qualify for participation in the Plan with two consecutive negative results to an official blood test named in paragraph (a)(1) of this section. A succeeding flock must be qualified for participation in the Plan's pullorum-typhoid program with a negative result to an official blood test named in paragraph (a)(1) of this section. Testing to qualify flocks for Plan participation must include the testing of all birds in infected flocks and succeeding flocks for a 12-month period, and shall be performed or physically supervised by a State Inspector; Provided, That at the discretion of the Official State Agency, a sample of at least 500 birds, rather than all birds in the flock, may be tested by the State Inspector if it is agreed upon by the Official State Agency, the flockowner, and the Administrator. If the State Inspector determines that a primary breeding flock has been exposed to S. pullorum or S. gallinarum, 2 the Official State Agency shall require:

(i) The taking of blood samples—performed by or in the presence of a State Inspector—from all birds on premises exposed to birds, equipment, supplies, or personnel from the primary breeding flock during the period when the State Inspector determined that exposure to S. pullorum or S. gallinarum occurred. 2

(ii) The banding of all birds of these premises—performed or physically supervised by a State Inspector—in order to identify any bird that tests positive; and

(iii) The testing of blood samples at an authorized laboratory using an official blood test named in paragraph (a)(1) of this section.

(8) All domesticated fowl, except waterfowl, on the farm of the participant shall either be properly tested to meet the same standards as the participating flock or these birds and their eggs shall be separated from the participating flock and its eggs.

(9) All tests for pullorum-typhoid in flocks participating in or candidates for participation in the Plan shall be reported to the Official State Agency within 10 days following the completion of such tests. All reactors shall be considered in determining the classification of the flock.

(10) Any drug, for which there is scientific evidence of masking the test reaction or hindering the bacteriological recovery of Salmonella organisms, shall not be fed or administered to poultry within 3 weeks prior to a test or bacteriological examination upon which a Salmonella classification is based.

(11) When suitable evidence, as determined by the Official State Agency or the State Animal Disease Control Official, indicates that baby or started poultry produced by participating hatcheries are infected with organisms for which the parent flock received an official control classification and this evidence indicates that the infection was transmitted from the parent flock, the Official State Agency may, at its discretion, require additional testing of the flock involved. If infection is found in the parent flock, its classification shall be suspended until the flock is requalified under the requirements for the classification. Furthermore, the Official State Agency may require that the hatching eggs from such flocks be removed from the incubator and destroyed prior to hatching. When Salmonella organisms are isolated from a specimen which originated in a participating hatchery, the Official State Agency shall attempt to locate the source of the infection. The results of the investigation and the action taken to eliminate the infection shall be reported by the Official State Agency to the Service.

(b) For Mycoplasma gallisepticum, M. meleagridis, and M. synoviae. (1) The official 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 reactors. Tests must be conducted in accordance with this paragraph (b) and in accordance with part 147 of this subchapter.

(2) The serological tests shall be conducted using M. gallisepticum, M. meleagridis, or M. synoviae antigens approved by the Department or the Official State Agency and shall be performed in accordance with the recommendations of the producer of the antigen.

(3) When reactors to the test for which the flock was tested are submitted to a laboratory as prescribed by the Official State Agency, the final status of the flock will be determined in accordance with part 147 of this subchapter.

(4) Any drug, for which there is scientific evidence of masking the test reaction or hindering the bacteriological recovery of mycoplasma organisms, shall not be fed or administered to poultry within three weeks prior to a test or bacteriological examination upon which a Mycoplasma classification is based.

(5) The official molecular examination procedures for M. gallisepticum are 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 subchapter.

(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) Enzyme-linked immunosorbent assay (ELISA) test. (A) The ELISA test must be conducted using test kits approved by the Department and the Official State Agency and must be conducted in accordance with the recommendations of the producer or manufacturer.

(B) When positive ELISA samples are identified, an AGID test must be conducted within 48 hours.

(ii) Agar gel immunodiffusion (AGID) test. (A) The AGID test must be conducted using reagents approved by the Department and the Official State Agency.

(B) The AGID test for avian influenza must be conducted in accordance with this section (within the NPIP Program Standards document, Program Standard A applies to blood and yolk testing procedures; alternatives to the program standards may also be approved by the Administrator under § 147.53 of this subchapter) for the avian influenza agar gel immunodiffusion (AGID) test. The test can be conducted on egg yolk or blood samples. The AGID test is not recommended for use in waterfowl.

(C) Positive tests for the AGID must be further tested by Federal Reference Laboratories using appropriate tests for confirmation. Final judgment may be based upon further sampling and appropriate tests for confirmation.

(2) Agent detection tests. Agent detection tests may be used to detect influenza A virus but not to determine hemagglutinin or neuraminidase subtypes. Samples for agent detection 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 Agency. The RRT-PCR must be conducted using the National Veterinary Services Laboratories (NVSL) official protocol for RRT-PCR or a test kit licensed by the Department and approved by the Official State Agency and the State Animal Health Official, and must be conducted by personnel who have passed an NVSL proficiency test. For non-National Animal Health Laboratory Network (NAHLN) authorized laboratories:

(1) RRT-PCR testing may be used by primary breeder company authorized laboratories.

(2) RRT-PCR testing can only be performed on their own breeding flocks and only used for routine surveillance.

(3) The authorized laboratory must have a quality system that is accredited as ISO/IEC 17025 or equivalent to perform the avian influenza RRT-PCR assay.

(4) The use of the RRT-PCR test by the authorized laboratory must be approved in the memorandum of understanding (MOU) between the authorized laboratory, the Official State Agency, and the State Animal Health Official(s) of both the location of the authorized laboratory and the location where the breeding flocks reside.

(5) Split samples for testing must occur between the authorized laboratory and a NAHLN laboratory at a frequency designated in the MOU.

(B) Positive results from the RRT-PCR must be further tested by Federal Reference Laboratories using appropriate tests for confirmation. Final judgment may be based upon further sampling and appropriate tests for confirmation.

(ii) USDA-licensed type A influenza antigen capture immunoassay (ACIA). (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 recommendations of the producer or manufacturer.

(B) Chicken and turkey flocks that test positive on the ACIA must be further tested using the RRT-PCR or virus isolation. Positive results from the RRT-PCR or virus isolation must be further tested by Federal Reference Laboratories using appropriate tests for confirmation. Final judgment may be based upon further sampling and appropriate tests for confirmation.

(3) The official determination of a flock as positive for the H5 or H7 subtypes of avian influenza may be made only by NVSL.

(e) For Newcastle Disease (ND). The official tests for ND are serological tests for antibody detection or molecular-based tests for antigen detection.

(a) The Official State Agency must develop a diagnostic surveillance program for H5/H7 low pathogenic avian influenza for all poultry in the State. The exact provisions of the program are at the discretion of the States. The Service will use the standards in paragraph (b) of this section in assessing individual State plans for adequacy, including the specific provisions that the State developed. The standards should be used by States in developing those plans.

(b) Avian influenza must be a disease reportable to the responsible State authority (State veterinarian, etc.) by all licensed veterinarians. To accomplish this, all laboratories (private, State, and university laboratories) that perform diagnostic procedures on poultry must examine all submitted cases of unexplained respiratory disease, egg production drops, and mortality for avian influenza by both an approved serological test and an approved antigen detection test. Memoranda of understanding or other means must be used to establish testing and reporting criteria (including criteria that provide for reporting H5 and H7 low pathogenic avian influenza directly to the Service) and approved testing methods. In addition, States should conduct outreach to poultry producers, especially owners of smaller flocks, regarding the importance of prompt reporting of clinical symptoms consistent with avian influenza.