National Poultry Improvement Plan and Auxiliary Provisions, 66631-66647 [2019-23973]

Download as PDF 66631 Proposed Rules Federal Register Vol. 84, No. 234 Thursday, December 5, 2019 This section of the FEDERAL REGISTER contains notices to the public of the proposed issuance of rules and regulations. The purpose of these notices is to give interested persons an opportunity to participate in the rule making prior to the adoption of the final rules. DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service 9 CFR Parts 56, 145, 146, and 147 [Docket No. APHIS-2018-0062] RIN 0579–AE49 National Poultry Improvement Plan and Auxiliary Provisions Animal and Plant Health Inspection Service, USDA. ACTION: Proposed rule. AGENCY: We are proposing to amend the regulations governing the National Poultry Improvement Plan (NPIP). These amendments would establish a U.S. Newcastle Disease Clean program within the NPIP, create an NPIP subpart specific to game birds, revise testing requirements, and clarify existing provisions of the regulations. We are also proposing to amend the regulations concerning the payment of indemnity and compensation for low pathogenic avian influenza to reflect current policy and operational practices, and to allow NPIP voting delegates to represent multiple States during the Biennial Conferences. These proposed changes were voted on and approved by the voting delegates at the NPIP’s 2018 National Plan Conference. DATES: We will consider all comments that we receive on or before February 3, 2020. ADDRESSES: You may submit comments by either of the following methods: • Federal eRulemaking Portal: Go to http://www.regulations.gov/#! docketDetail;D=APHIS-2018-0062. • Postal Mail/Commercial Delivery: Send your comment to Docket No. APHIS-2018-0062, Regulatory Analysis and Development, PPD, APHIS, Station 3A–03.8, 4700 River Road, Unit 118, Riverdale, MD 20737–1238. Supporting documents and any comments we receive on this docket may be viewed at http:// www.regulations.gov/#!docketDetail; jbell on DSKJLSW7X2PROD with PROPOSALS SUMMARY: VerDate Sep<11>2014 17:13 Dec 04, 2019 Jkt 250001 D=APHIS-2018-0062 or in our reading room, which is located in Room 1141 of the USDA South Building, 14th Street and Independence Avenue SW, Washington, DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through Friday, except holidays. To be sure someone is there to help you, please call (202) 799–7039 before coming. FOR FURTHER INFORMATION CONTACT: Dr. Elena Behnke, DVM, Senior Coordinator, National Poultry Improvement Plan, VS, APHIS, USDA, 1506 Klondike Road, Suite 101, Conyers, GA 30094–5104; (770) 922– 3496. SUPPLEMENTARY INFORMATION: Background The National Poultry Improvement Plan (NPIP, also referred to below as ‘‘the Plan’’) is a cooperative FederalState-industry mechanism for controlling certain poultry diseases. The Plan consists of a variety of programs intended to prevent and control poultry diseases. Participation in all Plan programs is voluntary, but breeding flocks, hatcheries, and dealers must first qualify as ‘‘U.S. Pullorum-Typhoid Clean’’ as a condition for participating in the other Plan programs. The Plan identifies States, independent flocks, hatcheries, dealers, and slaughter plants that meet certain disease control standards specified in the Plan’s various programs. As a result, customers can buy poultry that has tested clean of certain diseases or that has been produced under diseaseprevention conditions. The regulations in 9 CFR parts 56, 145, 146, and 147 (referred to below as the regulations) contain the provisions of the Plan. The Animal and Plant Health Inspection Service (APHIS) amends these provisions from time to time to incorporate new scientific information and technologies within the Plan, and to ensure the plan reflects changes to the poultry industry itself. The changes we are proposing, which are discussed below, were approved by the voting delegates at the Plan’s 2018 Biennial Conference. Participants and voting delegates at the Biennial Conference represented the poultry industry, flock owners, breeders, hatchery men, slaughter plants, poultry veterinarians, diagnostic laboratory personnel, Official State PO 00000 Frm 00001 Fmt 4702 Sfmt 4702 Agencies from cooperating States, and other poultry industry affiliates. The proposed amendments are discussed in the order they would appear in the regulations. Proposed Amendments to Part 56 Definitions The terms H5/H7 LPAI exposed and H5/H7 LPAI infection (infected) are currently defined in § 56.1 of the regulations in a manner that describes the risks or effects of poultry being exposed to or contracting the virus. The current definition of H5/H7 LPAI exposed provides that all birds or poultry associated with H5/H7 infected birds or poultry, whether it is via excrement or other materials, are automatically placed in the exposed category. This could be construed to suggest that an exposed flock is potentially infectious because the birds in the flock have had contact with the virus in some manner. However, this is not the case. Although ‘‘exposed’’ birds have been exposed to the virus, they are no longer shedding the virus and no longer considered to be potentially infectious. As such, they can go to slaughter to be controlled marketed, instead of being depopulated. Therefore, we are proposing to amend the terms and definitions of H5/H7 LPAI infection (infected) and H5/H7 LPAI exposed. The new terms would be H5/H7 LPAI virus exposed (non-infectious) and H5/ H7 LPAI virus actively infected (infectious). We are proposing to define H5/H7 LPAI virus exposed (noninfectious) in the following way. Poultry would be considered to be exposed (non-infectious) to H5/H7 LPAI for purposes of the regulations if: • Antibodies to the H5 or H7 subtype of the AI virus that are not a consequence of vaccination have been detected in poultry, and • Samples collected from the flock using real-time reverse transcription polymerase chain reaction (RT–PCR) or virus isolation are determined to be not infectious for H5/H7 LPAI. The definition would also provide that the official determination that H5/ H7 LPAI virus exposure has occurred is by the identification of antibodies to the H5 or H7 subtype of AI virus detected and may only be made by APHIS’ National Veterinary Services Laboratories (NVSL). E:\FR\FM\05DEP1.SGM 05DEP1 jbell on DSKJLSW7X2PROD with PROPOSALS 66632 Federal Register / Vol. 84, No. 234 / Thursday, December 5, 2019 / Proposed Rules We are proposing to define H5/H7 LPAI virus actively infected (infectious) in the following way. Poultry would be considered to be infected with H5/H7 LPAI for purposes of the regulations if: • H5/H7 LPAI virus has been isolated and identified as such from poultry; or • Viral antigen or viral RNA specific to the H5 or H7 subtype of AI virus has been detected in poultry. The definition would also provide that the official determination that H5/ H7 LPAI virus has been isolated and identified, or viral antigen or viral RNA specific to the H5 or H7 subtype of AI virus has been detected, may only be made by NVSL. We would also revise references to H5/H7 LPAI) infection (infected) and H5/H7 LPAI exposed throughout part 56 of the regulations to these two new terms instead. We believe the revised terms better clarify the distinction between exposed and infected poultry. We are also proposing to add definitions for cleaning, compensation, disinfection, indemnity, and virus elimination (VE) to § 56.1 of the regulations. We would define cleaning as the removal of gross contamination, organic material, and debris from the premises or respective structures, via mechanical means like sweeping (dry cleaning) and/ or the use of water and soap or detergent (wet cleaning), in order to minimize organic material to prepare for effective disinfection. We would define disinfection as methods used on surfaces to destroy or eliminate H5/H7 LPAI virus through physical (e.g., heat) or chemical (e.g., disinfectant) means, and would further specify that a combination of methods may be required. Section 56.3 of the regulations provides that APHIS may indemnify persons for cleaning and disinfection of premises, conveyances, and materials infected with or exposed to LPAI. While we believe it is clear from context that § 56.3 pertains only to cleaning and disinfection associated with elimination of LPAI virus, rather than any cleaning and disinfection activities whatsoever that may be conducted on an affected premises, adding definitions of the terms to the regulations would further clarify our intent. For a similar reason, we are proposing to add the term virus elimination after every reference to cleaning and disinfection in part 56 of the regulations. Virus elimination is the term used in many foreign countries for cleaning and disinfection measures conducted to destroy or eliminate all virus on an affected premises; we would VerDate Sep<11>2014 17:13 Dec 04, 2019 Jkt 250001 define it in that way in § 56.1. This would also underscore the restrictive sense in which cleaning and disinfection is being used within part 56. The term compensation would also be new to part 56. We would define compensation in § 56.1 as reimbursement for the activities associated with the depopulation of infected or exposed poultry, including the disposal of contaminated carcasses and materials and the cleaning and disinfection of premises, conveyances, and materials that came into contact with infected or exposed poultry. The definition would further provide that, in the case of contaminated materials, if the cost of cleaning and disinfection would exceed the value of the materials, or cleaning and disinfection would be impracticable for any reason, APHIS would base compensation on the fair market value (depreciated value) of those materials. Finally, the definition would specify that compensation does not include payment for depopulated birds or eggs destroyed, as those payments would constitute indemnity. We would define indemnity as payments representing the fair market value of destroyed birds and eggs. Indemnity would not include reimbursements for depopulation (by which we mean the act of depopulation, rather than the depopulated poultry), or for disposal, destroyed materials, or cleaning and disinfection (virus elimination) activities, as these would be covered under the definition of compensation. Currently, the regulations in part 56 refer only to indemnity, regardless of the activity for which APHIS is providing reimbursement. However, the procedures for the payment of indemnity for destroyed birds or eggs differ significantly from those for the payment of indemnity for cleaning and disinfection. As a result, APHIS’ Veterinary Services (VS) program, in conjunction with State departments of agriculture, has developed a guidance document, VS Guidance document 8601.2 that clarifies how the two processes differ.1 The guidance document makes the distinction between compensation and indemnity that we are proposing to codify in the regulations themselves. We would also amend part 56 throughout to change references to ‘‘indemnity’’ that pertain to reimbursement for activities, rather than the destroyed poultry or eggs themselves, to ‘‘compensation.’’ 1 See http://poultryimprovement.org/documents/ ISRCPGuidanceDocument.pdf. PO 00000 Frm 00002 Fmt 4702 Sfmt 4702 Payment of Indemnity The regulations in § 56.3 describe conditions for the payment of indemnity for H5/H7 LPAI. Paragraph (a) of the section lists activities that may be eligible for indemnity for H5/H7 LPAI: The destruction and disposal of infected poultry, the destruction of any eggs during outbreak testing, and disinfection of areas and materials that have come in contact with infected poultry. Paragraph (b) describes the percentage of costs that are eligible for indemnity for the listed activities, depending on certain criteria. Currently, paragraph (b) provides that, if poultry meet the definition of commercial, but does not participate in their respective NPIP Avian Influenza program, the maximum amount of indemnity that may be paid for eligible activities is 25 percent. Commercial poultry that do participate in Plan AI programs, however, may receive up to 100 percent indemnity. This paragraph currently does not reflect the fact that the NPIP regulations themselves specifically exempt poultry operations that fall below certain size thresholds from having to participate in the NPIP AI programs. The exemption numbers are currently listed in 9 CFR part 146. We are proposing to amend paragraph (b) to clarify that poultry operations that are exempted by the Plan regulations from having to participate in Plan AI programs because of their size may still receive up to 100 percent indemnity and/or compensation for eligible activities. Determination of Indemnity The current regulations in § 56.4 describe how APHIS determines fair market value regarding the destruction of infected or exposed poultry; this includes determining indemnity for cleaning and disinfection procedures. The regulations currently state that APHIS will use an appraisal by an APHIS official appraiser and State official appraiser, or, in instances when APHIS and State authorities agree, either the APHIS appraiser or State appraiser alone, to determine fair market value for indemnity for destroyed poultry and eggs. However, we have discontinued use of appraisers in favor of an indemnity calculator drawn from multiple data points in order to determine fair market value for destroyed birds and eggs. We are therefore proposing to amend § 56.4 to indicate that appraisal calculator values will be used to determine the amount of indemnity paid for destroyed birds and eggs. E:\FR\FM\05DEP1.SGM 05DEP1 Federal Register / Vol. 84, No. 234 / Thursday, December 5, 2019 / Proposed Rules Section 56.4 also describes how reimbursement may be paid for disposal activities. Currently, as a precondition for submitting a claim, the claimant, Cooperating State Agency, and APHIS must jointly enter into a cooperative agreement. However, State Agencies have stated that their participation in the cooperative agreement is not necessary. We are proposing to amend the regulations accordingly. Finally, § 56.4 describes how indemnity may be paid for cleaning and disinfection activities. Currently, we require the claimant, the Cooperating State Agency, and APHIS to enter into a compliance agreement. The claimant then submits receipts or other documentation regarding the activities, and APHIS evaluates them against the cleaning and disinfection procedures in § 56.5 of the regulations and the initial State response and containment plan, the requirements for which are found in § 56.10 of the regulations. To streamline reimbursement for cleaning and disinfection activities, we have developed a calculator for cleaning and disinfection as well, the APHIS flatrate virus elimination (VE) calculator. The calculator provides a per-squarefoot rate for premises with floor-raised birds and per-cubic-foot rate for premises with caged birds for cleaning and disinfection activities that we have previously determined to fall within the scope of the regulations as reimbursable activities. While the VE calculator covers the majority of production types and VE scenarios, it does not cover every possibility. In such instances, the existing procedures for claiming compensation for cleaning and disinfection would apply. The floorraised rates would be used by APHIS as the baseline for compensation in such instances, and the claimant would be afforded the opportunity to demonstrate through receipts or other documentation the uniqueness of his or her situation. jbell on DSKJLSW7X2PROD with PROPOSALS NPIP Certifications for Poultry Moved for Controlled Marketing Section 56.5 provides that, at the discretion of APHIS and the Cooperating State Agency, poultry that has been infected with or exposed to H5/H7 LPAI may be moved for controlled marketing rather than depopulated. We are proposing to amend the section to indicate that poultry moved for controlled marketing maintain their current NPIP certifications. This amendment would help provide assurances to slaughtering facilities that receive such flocks. VerDate Sep<11>2014 17:13 Dec 04, 2019 Jkt 250001 Revisions to Part 145 Definitions Section 145.1 of the regulations provides general definitions of terms used within the NPIP regulations. We are proposing to add a definition for the term Newcastle disease, and to revise the existing definition for avian influenza. Both the new definition and the revised definition would be modeled on the definitions of these terms found in the World Organization for Animal Health’s (OIE’s) Terrestrial Animal Health Code, to which the United States is a signatory.2 Specific Provisions for Participating Dealers Section 145.7 of the regulations requires participating dealers to follow all applicable provisions in part 145. However, the section refers to dealers in ‘‘poultry breeding stock, hatching eggs, or baby or started poultry’’ while the definition of dealer in § 145.1 refers to dealers as individuals or businesses that deal in commerce with hatching eggs, newly-hatched poultry, and/or started poultry. We are proposing to revise § 145.7 so that it refers to dealers using the same term as in the definition in § 145.1. The revised section would also indicate that dealers must comply with the regulations in the relevant part of the NPIP regulations. It would also specify the NPIP Program Standards that are applicable to such dealers, as well as the provisions of the NPIP regulations that provide for approval of alternatives to those standards. Testing The regulations in §§ 145.14 and 146.13 discuss the official avian influenza (AI) antibody detection tests, the enzyme-linked immunosorbent assay (ELISA) test and agar gel immunodiffusion (AGID) test, in regard to poultry testing requirements within the NPIP. We are proposing to require that, when ELISA test samples are positive for AI, an AGID test must be conducted within 48 hours. This is because the AGID test is used as a confirmatory test on presumptive positives using the ELISA test. Timely corroboratory testing is therefore necessary in order to determine the disease status of the tested flock. Additionally, the AGID test must comply with the relevant NPIP requirements and would specify the relevant NPIP Program Standards, as well as provide a citation to the 2 To view the Code, go to https://www.oie.int/ standard-setting/terrestrial-code/access-online/. PO 00000 Frm 00003 Fmt 4702 Sfmt 4702 66633 provisions for approval of alternate standards. Additionally, these sections currently provide that agent detection tests for AI may be used to detect influenza A matrix gene or protein. We are proposing to amend these sections to provide that agent detection tests may be used to detect influenza A virus rather than specifically influenza A matrix gene or protein. The existing limitation imposes an unnecessary technical restriction on test design and precludes the use of lateral flow antigen immunoassays that target the influenza nucleoprotein and still reliably indicate the presence or absence of AI in a test sample. For reasons that we discuss below, we are also proposing to add provisions regarding official tests for Newcastle disease (ND) to these two sections. The regulations would say that the official ND tests are serological tests for antibody detection and molecular-based tests for antigen detection that are listed in the Program Standards document as determined by APHIS to reliably detect ND infection. The Program Standards document would indicate that the approved serological tests for ND are currently the ELISA and hemagglutination inhibition (HI) tests, and the approved molecular-based test for ND is PCR. Proposed Newcastle Disease Clean Program The regulations in § 145.43 provide disease-free, or Clean, classifications that may be applied to turkey breeding flocks, and eggs and poults from turkey breeding flocks, provided that they meet certain requirements demonstrating freedom from that disease. Similar classification systems exist in § 145.45 for compartments within the turkey breeding-hatchery industry; § 145.73 for egg-type chicken breeding flocks, as well as their eggs and chicks; § 145.74 for compartments within the egg-type chicken breeding-hatchery industry; § 145.83 for meat-type chicken breeding flocks, as well as their eggs and chicks; and § 145.84 for compartments within the meat-type chicken breedinghatchery industry. We are proposing to amend each of these sections to establish an ND Clean program. The ND Clean program is intended to allow the turkey breedinghatchery, egg-type chicken breedinghatchery, and meat-type chicken breeding-hatchery industries, as well as compartments within those industries, to demonstrate freedom from ND based on vaccination and/or monitoring of each participating breeding flock. Lastly, in regards to this paragraph’s E:\FR\FM\05DEP1.SGM 05DEP1 jbell on DSKJLSW7X2PROD with PROPOSALS 66634 Federal Register / Vol. 84, No. 234 / Thursday, December 5, 2019 / Proposed Rules language, we note that the original voting resolution in § 145.43 stated ‘‘vaccination and monitoring of each participating breeding flock;’’ however, given that vaccination is optional, we have replaced ‘‘and’’ with ‘‘and/or’’ to accurately reflect the intended requirements. For a flock to gain ND Clean status, the Official State Agency (OSA) would have to determine that the flock is a primary breeding flock that either (1) has been vaccinated for ND using USDA-licensed vaccines and response to vaccination is serologically monitored using an approved serological ND test when the birds are more than 4 months of age; or (2) is unvaccinated for ND, in which a minimum of 30 birds have tested negative to ND using an approved test when more than 4 months of age. We would require serological testing for vaccinated flocks because it indicates the increased presence of antibodies in vaccinated birds. To retain ND Clean classification for a vaccinated flock, the vaccine would have to be a USDA-licensed vaccine administered during the early stages of development through rearing, and an inactivated vaccine as final vaccination prior to the onset of egg production; the flock would have to be have been monitored for antibody response using an approved serological test (again, currently the ELISA or HI test) and the results would have to be compatible with immunological response against ND vaccination; and testing would have to include a minimum of 30 birds with a serologic monitoring program when the birds are more than 4 months of age and prior to the onset of production and not longer than every 90 days thereafter. To retain ND Clean classification for unvaccinated flocks, during each 90-day period, all primary spent fowl, up to a maximum of 30, would have to test negative to ND within 21 days prior to movement to slaughter; and either a minimum of 30 birds for flock would have to test negative using an approved ND test (either serological or molecularbased) at intervals of 90 days, or a sample of fewer than 30 birds could be tested, provided that all pens are equally represented and a total of 30 birds is tested within each 90 day period. Finally, for an ND Clean program for flocks to exist within a State, ND would have to be a disease reportable to the responsible State authority by all licensed veterinarians within the State. To accomplish this, all laboratories (including private, State, and university laboratories) that perform diagnostic procedures on poultry would have to VerDate Sep<11>2014 17:13 Dec 04, 2019 Jkt 250001 examine all submitted cases of unexplained respiratory disease, egg production drops, and mortality for ND. In § 145.15 of the regulations, as a general NPIP requirement, we require diagnostic surveillance for LPAI within participating States. Part of this diagnostic surveillance must include LPAI being a reportable disease. This requirement for the ND Clean program is modeled on that existing requirement for LPAI surveillance. The requirements for ND Clean compartments would be similar to the existing requirements for AI Clean compartments, and we would accordingly revise sections of the regulations regarding the establishment and maintenance of AI Clean compartments so that they would also apply to the establishment and maintenance of ND Clean Compartments. Removal of the Pullorum Typhoid Agglutination Test for S. Enteritidis Clean Classifications The regulations in §§ 145.23(d), 145.73(d), and 145.83(d) contain requirements for S. Enteritidis Clean classifications in the multiplier egg-type chicken breeding industry, primary eggtype chicken breeding industry, and primary meat-type chicken breeding industry, respectively. We are proposing to remove testing using the pullorumtyphoid (PT) agglutination test from the U.S. S. Enteritidis Clean classification requirements. The PT agglutination test was adopted as a test for S. enteritidis in the 1980s based on similarities between the two diseases, and on the presumption that it could be used for both diseases. However, the test has since proven to be unreliable in detecting the presence of S. enteritidis. It would, however, continue to be used for testing for PT, for which it is reliable. Revisions to Testing Protocols for AI in the Multiplier Meat-Type Chicken Breeding Industry Section 145.33 contains, among other things, requirements for determining a participating multiplier meat-type chicken breeding flock is free of AI for purposes of a Clean classification. Paragraph (l)(1) of that section provides three different possible testing protocols for a flock to retain Clean status. While the first option states at least 15 birds must test negative at intervals of 90 days, and the third option requires a total of 15 samples collected and tested within a 90 day period, the second option requires 30 birds to be tested within each 90 day testing period. Our intent has always been that a total of 15 PO 00000 Frm 00004 Fmt 4702 Sfmt 4702 birds must be tested in each of the three options to retain the AI Clean classification; the discrepancy in the second option is the result of a drafting error. We are proposing to revise the second option to correct this error. The section also currently requires serological tests for testing of multiplier spent fowl. This limitation is not warranted because molecular-based tests such as PCR are also reliable for such testing. We are proposing to revise the section so that any AI test approved in accordance with § 145.14 may be used. Proposed Revisions to NPIP Provisions for Hobbyist and Exhibition Waterfowl, Exhibition Poultry and Raised-forRelease Waterfowl Breeding Flocks and Products Subpart E of part 145, ‘‘Special Provisions for Hobbyist and Exhibition Waterfowl, Exhibition Poultry, and Game Bird Breeding Flocks and Products’’ (§§ 145.51–145.54), contains Plan requirements specific to the hobbyist, exhibition, and game bird industries. We are proposing several changes to this subpart. First, we are proposing to remove all references to game birds from subpart E due to the addition of proposed subpart J to part 145. The game bird industry has grown rapidly and has become more complex since its inception, and the terminology, production methods, and end uses in the industry are now significantly different than those in other poultry industries. Currently, subpart E does not have specific requirements for any one group of birds covered by its provisions, and subpart J would add testing regimes, terminology, and programs specifically designed for the game bird industry. In addition to the removal of game bird references, we would revise all references to ‘‘waterfowl’’ within the subpart to instead refer to ‘‘raised-forrelease waterfowl,’’ and would remove the definition for waterfowl from § 145.51 of the regulations, and add a definition for raised-for-release waterfowl in its place. We are proposing to define raised-for-release waterfowl as domesticated fowl that normally swim, such as ducks and geese, grown under confinement for the primary purpose of producing eggs, chicks, started, or mature birds for release on game preserves or in the wild. Waterfowl is currently defined in § 145.51 as domesticated fowl that normally swim, such as ducks and geese, and it is only apparent from subsequent sections of subpart E that the subpart does not apply to meat-type waterfowl, which are instead covered by E:\FR\FM\05DEP1.SGM 05DEP1 Federal Register / Vol. 84, No. 234 / Thursday, December 5, 2019 / Proposed Rules jbell on DSKJLSW7X2PROD with PROPOSALS the provisions of a separate subpart I. These revisions would help to further clarify the scope of subpart E. We are also proposing to add a definition for hobbyist poultry. We would define hobbyist poultry as domesticated fowl which are bred for the purposes of meat and/or egg production on a small scale as determined by the Official State Agency. This would also help clarify the scope of subpart E. Section 145.52 contains requirements that flocks of hobbyist and exhibition waterfowl, exhibition poultry, and game bird breeding flocks, and the eggs and baby poultry produced from them, must meet in order to participate in the Plan. We are proposing to amend the introductory text of the section to remove the term ‘‘baby poultry’’ and instead indicate that it applies to chicks, started, and mature poultry. This will provide more clarity regarding the applicability of the section and align it with the terminology used elsewhere in part 145 of the regulations. We are also proposing revisions to the introductory text that reflect the usage the term ‘‘raised-for-release waterfowl’’ throughout the subpart and the creation of a new subpart J for gamebirds. Paragraph (c) of § 145.52 currently recommends that waterfowl and gallinaceous flocks in open-air facilities be kept separate. However, it is a best practice not to commingle waterfowl, which can act as asymptomatic vectors of disease, and gallinaceous flocks, regardless of whether they are kept in contained or open-air facilities. We are proposing to amend paragraph (c) accordingly. Finally, we are proposing to add a paragraph (f) to the section to indicate that all participating raised-for-release waterfowl flocks, whether breeders or non-breeders, will be considered to be enrolled under subpart E of part 145 of the regulations. While provisions for non-breeding raised-for-release flocks are contained in part 146 of the regulations, rather than part 145, the testing requirements are identical. This will afford Plan participants some discretion in revising the intended use of a particular flock without jeopardizing the flock’s status. Terminology and Classification; Flocks and Products Section 145.53 of the regulations provide Clean classifications that may be applied to participating hobbyist and exhibition waterfowl, exhibition poultry, and game bird breeding flocks, and the eggs and baby poultry produced from them, provided that they meet certain requirements demonstrating VerDate Sep<11>2014 17:13 Dec 04, 2019 Jkt 250001 freedom from that disease. We are proposing several changes to this section. This section would also discuss that hatcheries should be kept in sanitary conditions according to their relevant subpart and would specify the applicable part of the NPIP Program Standards that pertains to such hatcheries. In paragraph (b)(5), we are proposing to remove the term ‘‘exhibition waterfowl’’ and use the term ‘‘exhibition poultry.’’ Additionally, paragraph (f) of § 145.53 contains requirements for a Salmonella Monitored classification. The Salmonella program currently only contains Salmonella testing and interventions at the hatchery level, and calls for five environmental samples from a hatchery every 30 days performed at an authorized laboratory in order for breeders to claims their products are monitored for Salmonella. We are proposing to add requirements for representative sampling of pullets and breeder farms. Hatched chicks transferred to farms are still at risk of contracting Salmonella. Special Provisions for Egg/Meat-Type Game Bird and Raised-for-Release Game Bird Breeding Flocks and Products As we mentioned above, we are proposing to establish a new subpart J for the game bird industry. We are amending §§ 145.24, 145.34, 145.44, 145.54, and 145.94 to align them with the rest of the section regarding testing. The separation of the game bird industry from hobby and exhibition poultry in subpart E is necessary because the current definitions and provisions do not match the production methods and end uses for the game bird industry. Subpart J would consist of four sections: §§ 145.101 for definitions, 145.102 for participation, 145.103 for terminology and classification of flocks and products, and 145.104 for terminology and classification of States. The requirements in proposed subpart J are drawn from the existing requirements in subpart E; however, some of the definitions, terms, and provisions would be unique to subpart J, and reflect the unique nature of the game bird industry. Key differences between subpart E and subpart J include the following: • In subpart J, we are proposing to allow breeders to also hatch and/or grow out birds and still meet the definition of breeder. This will have the effect of allowing premises with breeding and ‘‘grow out’’ birds to be covered under one NPIP number, and PO 00000 Frm 00005 Fmt 4702 Sfmt 4702 66635 will account for a common production model in the game bird industry. • We are proposing definitions for the terms dealer, grower, and hatchery. Subpart E relies on the general definition for dealer in § 145.1 of the regulations, and does not contain definitions for growers or hatcheries. However, in order for NPIP to accurately register game bird operations, definitions of these three terms are warranted within subpart J. • The terms chick, egg, mature bird, and started bird, and raised-for-release bird would be defined within subpart J. Definitions are warranted in order to characterize these products within the game bird industry. • While subpart E requires hatching eggs produced by breeding flocks to be fumigated or otherwise sanitized, subpart J would provide a third option in addition to fumigation or sanitization, ‘‘nest cleaning.’’ ‘‘Nest clean’’ eggs are produced within the game bird industry on wire or otherwise away from the litter. • We are proposing to allow a breeder, hatchery, or grower to also be a dealer without being categorized as a dealer, provided that, when reselling products, the breeder, hatchery, or grower has purchased those products from an NPIP participant with equal or greater classifications or from a flock with equivalent or greater testing requirements under official supervision. This allowance would simplify the registration and recordkeeping process for Plan participants within the game bird industry. • The Pullorum-Typhoid Clean classification requirements reflect the terminology and production methods in the game bird industry. Proposed Amendments to Part 146 Part 146, subpart E, contains definitions and requirements for Plan participants within the game bird, commercial waterfowl, and raised-forrelease waterfowl industries who produce meat- or egg-type flocks. We are proposing to update the terminology in subpart E to match the other subparts within part 146 by replacing the term ‘‘commercial’’ with ‘‘egg/meat-type.’’ Additionally, we are proposing to eliminate all provisions related to ‘‘grow-out’’ production from part 146; such poultry would be included in subpart E and our proposed subpart J within part 145. Proposed Amendments to Part 147 Official Delegates Section 147.45 provides requirements regarding delegation and voter E:\FR\FM\05DEP1.SGM 05DEP1 66636 Federal Register / Vol. 84, No. 234 / Thursday, December 5, 2019 / Proposed Rules representation for the NPIP’s Biennial Conferences. The text currently states that each cooperating State is entitled to one official delegate for each of the programs in parts 145 and 146. We are proposing to allow a single, participating delegate to represent multiple States. Companies often have operations in various States, and this change would help those companies save money by appointing a single individual to represent all of the States where the company has operations. Approval of Conference Recommendations by the Department Section 147.48 discusses the incorporation of recommendations from the NPIP Biennial Conferences into the NPIP provisions. The regulations do not currently have an established timeframe for the publication of NPIP Biennial Conference proposed changes; therefore, we are proposing to establish that we would publish a proposed rule to amend the regulations in the Federal Register within 14 months of the Biennial Conference. This will help ensure that, when a Biennial Conference is reviewing recommendations for amendments to the regulations, the regulations are up-to-date at the time of the Conference. Authorized Laboratories jbell on DSKJLSW7X2PROD with PROPOSALS In § 147.52, the regulations state the minimum requirements for an APHIS authorized laboratory evaluation to ensure that they are in compliance with NPIP regulations. Within § 147.52, paragraph (b) contains requirements to be a trained laboratory technician. Currently, testing procedures may only be overseen by technicians who successfully complete Service-approved laboratory workshops for Plan-specific diseases within the past 4 years. We are proposing to amend § 147.52(b) by removing the word ‘‘within’’ and replacing it with the word ‘‘every.’’ Technicians should attend a workshop for an individual Plan at 4year intervals versus any time during a 4-year span. We are also proposing a minor editorial change to the paragraph which will indicate that ‘‘all authorized laboratories’’ must be overseen by a technician who meets the aforementioned criteria. Executive Orders 12866 and 13771 and Regulatory Flexibility Act This proposed rule has been determined to be not significant for the purposes of Executive Order 12866 and, therefore, has not been reviewed by the Office of Management and Budget. Further, because this rule is not VerDate Sep<11>2014 17:13 Dec 04, 2019 Jkt 250001 significant, it is not a regulatory action under Executive Order 13771. In accordance with the Regulatory Flexibility Act, we have analyzed the potential economic effects of this action on small entities. The analysis is summarized below. Copies of the full analysis are available by contacting the person listed under FOR FURTHER INFORMATION CONTACT or on the Regulations.gov website (see ADDRESSES above for instructions for accessing Regulations.gov). This rulemaking would result in various changes to regulations in 9 CFR parts 56 and 145 through 147, modifying provisions of the NPIP. The modifications are recommended by the NPIP General Conference Committee (GCC), which represents cooperating State agencies and poultry industry members and advises the Secretary on issues pertaining to poultry health. The proposed rule would, among other changes, remove the Pullorum-Typhoid agglutination test as a test under which a flock can achieve Salmonella enteritidis clean classification, due to its unreliability; propose a Newcastle Disease Clean Program; specify that ELISA-positive samples for Avian Influenza (AI) must be sent for corroboratory testing within 48 hours; and broaden the criteria under which AI detection tests can be approved, while still requiring that the tests reliably detect AI virus. In addition, the proposed rule would clarify the testing period for AI tests to maintain AI Clean classification by correcting an editorial error; clarify that flocks that have been designated exposed to HPAI are not considered infectious; clarify when indemnity may be paid to breeders within the NPIP program; clarify the types of poultry in commerce; and clarify that NPIP dealers must follow the Program Standards in addition to the regulations. The proposal would create NPIP provisions specific to the game bird breeders industry and would set forth Salmonella testing for breeders, in addition to hatchers, relative to Salmonella Monitored status. These changes would align the regulations with international standards and make them more transparent to APHIS stakeholders and the general public. The changes included in this rule were voted on and approved by the voting delegates at the Plan’s 2018 Biennial Conference. The establishments that would be affected by the rule—principally entities engaged in poultry production and processing—are predominantly small by Small Business Administration standards. In those instances in which an addition or modification could PO 00000 Frm 00006 Fmt 4702 Sfmt 4702 potentially result in a cost to certain entities, we do not expect the costs to be significant. This rule embodies changes decided upon by the NPIP GCC on behalf of Plan members, that is, changes recognized by the poultry industry as in their interest. We note that NPIP membership is voluntary. Under these circumstances, the Administrator of the Animal and Plant Health Inspection Service has determined that this action, if promulgated, will not have a significant economic impact on a substantial number of small entities. Executive Order 12372 This program/activity is listed in the Catalog of Federal Domestic Assistance under No. 10.025 and is subject to Executive Order 12372, which requires intergovernmental consultation with State and local officials. (See 2 CFR chapter IV.) Executive Order 12988 This proposed rule has been reviewed under Executive Order 12988, Civil Justice Reform. If this proposed rule is adopted: (1) All State and local laws and regulations that are in conflict with this rule will be preempted; (2) no retroactive effect will be given to this rule; and (3) administrative proceedings will not be required before parties may file suit in court challenging this rule. Paperwork Reduction Act In accordance with Section 3507(d) of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.), the reporting, recordkeeping, and third-party disclosure requirements included in this proposed rule have been submitted for approval to the Office of Management and Budget (OMB). Please send comments on the Information Collection Request (ICR) to OMB’s Office of Information and Regulatory Affairs via email to oira_submissions@ omb.eop.gov, Attention: Desk Officer for APHIS, Washington, DC 20503. Please state that your comments refer to Docket No. APHIS–2018–0062. Please send a copy of your comments to the USDA using one of the methods described under ADDRESSES at the beginning of this document. APHIS is proposing to amend the National Poultry Improvement Program regulations to establish a U.S. Newcastle Disease Clean program within NPIP. The Newcastle Disease Clean program is intended to allow the turkey breedinghatchery, egg-type chicken breedinghatchery, and meat-type chicken breeding-hatchery industries, as well as compartments within those industries, to demonstrate freedom from ND based E:\FR\FM\05DEP1.SGM 05DEP1 jbell on DSKJLSW7X2PROD with PROPOSALS Federal Register / Vol. 84, No. 234 / Thursday, December 5, 2019 / Proposed Rules on vaccination and/or monitoring of each participating breeding flock. APHIS intends to determine the presence of Newcastle disease virus through vaccination and monitoring of each participating breeding flock. Implementing this rule will require information collection activities such as a revised flock selecting and testing reports; applications for U.S. Avian Flu and Newcastle Disease clean compartment, clean compartment component registrations, and compartment component removal; component audits; compliance statements; compliance agreements; description of business processes; biosecurity plans; appraisal and indemnity claims; response and containment plans; and recordkeeping. We are soliciting comments from the public (as well as affected agencies) concerning our proposed information collection requirements. These comments will help us: (1) Evaluate whether the proposed information collection is necessary for the proper performance of our agency’s functions, including whether the information will have practical utility; (2) Evaluate the accuracy of our estimate of the burden of the proposed information collection, including the validity of the methodology and assumptions used; (3) Enhance the quality, utility, and clarity of the information to be collected; and (4) Minimize the burden of the information collection on those who are to respond (such as through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology; e.g., permitting electronic submission of responses). Estimate of burden: Public burden for this collection of information is estimated to average 1.84 hours per response. Respondents: Commercial poultry producers and State agricultural officials. Estimated annual number of respondents: 1,361. Estimated annual number of responses per respondent: 18. Estimated annual number of responses: 23,857. Estimated total annual burden on respondents: 43,810 hours. (Due to averaging, the total annual burden hours may not equal the product of the annual number of responses multiplied by the reporting burden per response.) A copy of the information collection may be viewed on the Regulations.gov website or in our reading room. (A link to Regulations.gov and information on VerDate Sep<11>2014 17:13 Dec 04, 2019 Jkt 250001 the location and hours of the reading room are provided under the heading ADDRESSES at the beginning of this proposed rule.) Copies can also be obtained from Mr. Joseph Moxey, APHIS’ Information Collection Coordinator, at (301) 851–2483. APHIS will respond to any ICR-related comments in the final rule. All comments will also become a matter of public record. E-Government Act Compliance The Animal and Plant Health Inspection Service is committed to compliance with the E-Government Act to promote the use of the internet and other information technologies, to provide increased opportunities for citizen access to Government information and services, and for other purposes. For information pertinent to E-Government Act compliance related to this proposed rule, please contact Mr. Joseph Moxey, APHIS’ Information Collection Coordinator, at (301) 851– 2483. List of Subjects 9 CFR Part 56 Animal diseases, Indemnity payments, Low pathogenic avian influenza, Poultry. 9 CFR Parts 145, 146, and 147 Animal diseases, Poultry and poultry products, Reporting and recordkeeping requirements. Accordingly, we propose to amend 9 CFR parts 56, 145, 146, and 147 as follows: PART 56—CONTROL OF H5/H7 LOW PATHOGENIC AVIAN INFLUENZA 1. The authority citation for part 56 continues to read as follows: ■ Authority: 7 U.S.C. 8301–8317; 7 CFR 2.22, 2.80, and 371.4. 2. Section 56.1 is amended as follows: a. By adding, in alphabetical order, definitions for Cleaning, Compensation, and Disinfection; ■ b. By removing the definitions for H5/ H7 LPAI exposed and H5/H7 LPAI infection (infected); and ■ c. By adding, in alphabetical order, definitions for H5/H7 LPAI virus actively infected (infectious), H5/H7 LPAI virus exposed (non-infectious), Indemnity, and Virus elimination (VE). The additions read as follows: ■ ■ § 56.1 Definitions. * * * * * Cleaning. The removal of gross contamination, organic material, and debris from the premises or respective PO 00000 Frm 00007 Fmt 4702 Sfmt 4702 66637 structures, via mechanical means like sweeping (dry cleaning) and/or the use of water and soap or detergent (wet cleaning), in order to minimize organic material to prepare for effective disinfection. * * * * * Compensation. In the case of H5/H7 LPAI detection, compensation specifically refers to reimbursement for the activities associated with the depopulation of infected or exposed poultry, including the disposal of contaminated carcasses and materials and the cleaning and disinfection of premises, conveyances, and materials that came into contact with infected or exposed poultry. In the case of contaminated materials, if the cost of cleaning and disinfection would exceed the value of the materials, or cleaning and disinfection would be impracticable for any reason, APHIS will base compensation on the fair market value (depreciated value) of those materials. Compensation does not include payment for depopulated birds or eggs destroyed (see definition of Indemnity in this section). * * * * * Disinfection. Methods used on surfaces to destroy or eliminate H5/H7 LPAI virus through physical (e.g., heat) or chemical (e.g., disinfectant) means. A combination of methods may be required. * * * * * H5/H7 LPAI virus actively infected (infectious). (1) Poultry will be considered to be infected with H5/H7 LPAI for the purposes of this part if: (i) H5/H7 LPAI virus has been isolated and identified as such from poultry; or (ii) Viral antigen or viral RNA specific to the H5 or H7 subtype of AI virus has been detected in poultry. (2) The official determination that H5/ H7 LPAI virus has been isolated and identified, or viral antigen or viral RNA specific to the H5 or H7 subtype of AI virus has been detected, may only be made by the National Veterinary Services Laboratories. H5/H7 LPAI virus exposed (noninfectious). (1) Poultry will be considered to be exposed (noninfectious) to H5/H7 LPAI for the purposes of this part if: (i) Antibodies to the H5 or H7 subtype of the AI virus that are not a consequence of vaccination have been detected in poultry; and (ii) Samples collected from the flock using real-time reverse transcription polymerase chain reaction (RT–PCR) or virus isolation are determined to be not infectious for H5/H7 LPAI. E:\FR\FM\05DEP1.SGM 05DEP1 66638 Federal Register / Vol. 84, No. 234 / Thursday, December 5, 2019 / Proposed Rules (2) The official determination that H5/ H7 LPAI virus exposure has occurred is by the identification of antibodies to the H5 or H7 subtype of AI virus detected and may only be made by the National Veterinary Services Laboratories. Indemnity. Payments representing the fair market value of destroyed birds and eggs. Indemnity does not include reimbursements for depopulation, disposal, destroyed materials, or cleaning and disinfection (virus elimination) activities (see definition of Compensation in this section). * * * * * Virus elimination (VE). Cleaning and disinfection measures conducted to destroy or eliminate all AI virus on an affected premises. ■ 3. Section 56.3 is amended by revising the section heading and paragraphs (a) introductory text and (b) and (c) to read as follows: jbell on DSKJLSW7X2PROD with PROPOSALS § 56.3 Payment of indemnity and/or compensation. (a) Activities eligible for indemnity and/or compensation. The Administrator may pay indemnity and/ or compensation for the activities listed in this paragraph (a), as provided in paragraph (b) of this section: * * * * * (b) Percentage of costs eligible for indemnity. Except for poultry that are described by the categories in this paragraph (b), the Administrator is authorized to pay 100 percent of the costs and/or compensation, as determined in accordance with § 56.4, of the activities described in paragraphs (a)(1) through (3) of this section, regardless of whether the infected or exposed poultry participate in the Plan. For infected or exposed poultry that are described by the categories in this paragraph (b), the Administrator is authorized to pay 25 percent of the costs of the activities described in paragraphs (a)(1) through (3) of this section: (1)(i) The poultry are from a breeding flock, commercial flock, or slaughter plant that participates in any Plan program in part 145 or 146 of this chapter but that does not participate in the U.S. Avian Influenza Clean, U.S. H5/H7 Avian Influenza Clean, or U.S. H5/H7 Avian Influenza Monitored program of the Plan available to the flock in part 145 or 146 of this chapter; and (ii) The poultry are from: (A) A commercial table-egg laying premises with at least 75,000 birds; or (B) A meat-type chicken slaughter plant that slaughters at least 200,000 meat-type chickens in an operating week; or VerDate Sep<11>2014 17:13 Dec 04, 2019 Jkt 250001 (C) A meat-type turkey slaughter plant that slaughters at least 2 million meattype turkeys in a 12 month period; or (D) A commercial waterfowl and commercial upland game bird slaughter plant that slaughters at least 50,000 birds annually; or (E) A raised-for-release upland game bird premises, raised-for-release waterfowl premises, and commercial upland game bird or commercial waterfowl producing eggs for human consumption premises that raise at least 25,000 birds annually; or (F) A breeder flock premises with at least 5,000 birds. (2) The poultry are located in a State that does not participate in the diagnostic surveillance program for H5/ H7 LPAI, as described in § 146.14 of this chapter, or that does not have an initial State response and containment plan for H5/H7 LPAI that is approved by APHIS under § 56.10, unless such poultry participate in the Plan with another State that does participate in the diagnostic surveillance program for H5/ H7 LPAI, as described in § 146.14 of this chapter, and has an initial State response and containment plan for H5/ H7 LPAI that is approved by APHIS under § 56.10. (c) Other sources of payment. If the recipient of indemnity and/or compensation for any of the activities listed in paragraphs (a)(1) through (3) of this section also receives payment for any of those activities from a State or from other sources, the indemnity and/ or compensation provided under this part may be reduced by the total amount of payment received from the State or other sources to the extent that total payments do not exceed 100 percent of total reimbursable indemnity and/or compensation amounts. ■ 4. Section 56.4 is revised to read as follows: § 56.4 Determination of indemnity and/or compensation amounts. (a) Destruction and disposal of poultry. (1) Indemnity for the destruction of poultry and/or eggs infected with or exposed to H5/H7 LPAI will be based on the fair market value of the poultry and/or eggs, as determined by an appraisal. The appraisal will use the current APHIS appraisal calculator values; if no such calculator value exists, an APHIS official appraiser will provide an appraisal of fair market value. An indemnity request form must be signed by the owners and grower (if applicable) of the poultry and received by APHIS prior to the destruction of the poultry and eggs, unless the owners, grower, APHIS, and the Cooperating State PO 00000 Frm 00008 Fmt 4702 Sfmt 4702 Agency agree in writing that the poultry may be destroyed immediately. Reports of appraisals must show the number of birds and the value per head. Complete inventory records of all birds and/or eggs on the premises must be provided to APHIS prior to the start of depopulation. (2) Compensation for disposal of poultry and/or eggs infected with or exposed to H5/H7 LPAI will be based on receipts or other documentation maintained by the claimant verifying expenditures for disposal activities authorized by this part. Any disposal of poultry infected with or exposed to H5/ H7 LPAI for which compensation is requested must be performed under a compliance agreement between the claimant and APHIS. APHIS will review claims for compensation for disposal to ensure that all expenditures relate directly to activities described in § 56.5 and in the initial State response and containment plan described in § 56.10. If disposal is performed by the Cooperating State Agency, APHIS will compensate the Cooperating State Agency for disposal under a cooperative agreement. (3) The destruction and disposal of the poultry and/or eggs must be conducted in accordance with the initial State response and containment plan for H5/H7 LPAI, as described in § 56.10. (b) Cleaning and disinfection (virus elimination). (1) Compensation for cleaning and disinfection (virus elimination) of premises, conveyances, and materials that came into contact with poultry that are infected with or exposed to H5/H7 LPAI will be determined using the current APHIS flat-rate virus elimination (VE) calculator in effect at the time of the infection. (2) For premises types for which a flat-rate VE calculator is not available, reimbursement will be based on receipts or other documentation maintained by the claimant verifying expenditures for cleaning and disinfection (virus elimination) activities authorized by this part. Any cleaning and disinfection (virus elimination) of premises, conveyances, and materials for which compensation is requested must be performed under a compliance agreement between the claimant, the Cooperating State Agency, and APHIS. APHIS will review claims for compensation for cleaning and disinfection (virus elimination) to ensure that all expenditures relate directly to activities described in § 56.5 and in the initial State response and containment plan described in § 56.10. (i) In the case of materials, if the cost of cleaning and disinfection (virus E:\FR\FM\05DEP1.SGM 05DEP1 jbell on DSKJLSW7X2PROD with PROPOSALS Federal Register / Vol. 84, No. 234 / Thursday, December 5, 2019 / Proposed Rules elimination) would exceed the value of the materials or cleaning and disinfection (virus elimination) would be impracticable for any reason, compensation for the destruction of the materials will be based on the fair market value (depreciated value) of those materials, as determined by an appraisal. Materials will be appraised by an APHIS official appraiser. Compensation for disposal of the materials will be based on receipts or other documentation maintained by the claimant verifying expenditures for disposal activities authorized by this part. Appraisals of materials must be reported on forms furnished by APHIS and must be signed by the appraisers and by the owners of the materials to indicate agreement with the appraisal amount. Appraisals of materials must be signed and received by APHIS prior to the disassembly or destruction of the materials, unless the owners, APHIS, and the Cooperating State Agency agree in writing that the materials may be disassembled and/or destroyed immediately. Any disposal of materials for which compensation is requested must be performed under a compliance agreement between the claimant, the Cooperating State Agency, and APHIS. APHIS will review claims for compensation for disposal to ensure that all expenditures relate directly to activities described in § 56.5 and in the initial State response and containment plan described in § 56.10. (ii) [Reserved] (c) Requirements for compliance agreements. The compliance agreement is a comprehensive document that describes the depopulation, disposal, and cleaning and disinfection (virus elimination) plans for poultry that were infected with or exposed to H5/H7 LPAI, or a premises that contained such poultry. The compliance agreement must set out cost estimates that include labor, materials, supplies, equipment, personal protective equipment, and any additional information deemed necessary by APHIS. A compliance agreement must indicate what tasks will be completed, who will be responsible for each task, and how much the work is expected to cost. Once work associated with the compliance agreement is completed, receipts and documentation detailing the activities specified in the agreement should be forwarded to APHIS for review, approval, and final payment. This documentation should be submitted to APHIS no later than 30 days after the quarantine release of the affected or exposed premises. VerDate Sep<11>2014 17:13 Dec 04, 2019 Jkt 250001 (Approved by the Office of Management and Budget under control number 0579–0007) 5. Section 56.5 is amended as follows: a. By revising the section heading; b. In paragraph (c)(1) introductory text, by adding the words ‘‘and maintain their current National Poultry Improvement Plan (NPIP) certifications’’ after the words ‘‘controlled marketing’’; and ■ c. By revising paragraphs (c)(2) and (d). The revisions read as follows: ■ ■ ■ § 56.5 Destruction and disposal of poultry and cleaning and disinfection (virus elimination) of premises, conveyances, and materials. * * * * * (c) * * * (2) Poultry moved for controlled marketing will not be eligible for indemnity under § 56.3. However, any costs related to cleaning and disinfection (virus elimination) of premises, conveyances, and materials that came into contact with poultry that are moved for controlled marketing will be eligible for compensation under § 56.3. (d) Cleaning and disinfection (virus elimination) of premises, conveyances, and materials. Premises, conveyances, and materials that came into contact with poultry infected with or exposed to H5/H7 LPAI must be cleaned and disinfected; Provided, that materials for which the cost of cleaning and disinfection would exceed the value of the materials or for which cleaning and disinfection would be impracticable for any reason may be destroyed and disposed. Cleaning and disinfection must be performed in accordance with the initial State response and containment plan described in § 56.10, which must be approved by APHIS. Cleaning and disinfection must also be performed in accordance with any applicable State and local environmental regulations. ■ 6. Section 56.6 is amended as follows: ■ a. By revising the section heading; ■ b. In paragraph (a), by removing the word ‘‘Compensation’’ and adding the word ‘‘Indemnity’’ in its place; ■ c. By revising paragraph (b); and ■ d. In paragraph (c), by adding the words ‘‘(virus elimination)’’ after the word ‘‘disinfection’’ each time it appears. The revisions read as follows: § 56.6 Presentation of claims for indemnity and/or compensation. * * * * * (b) Indemnity for the value of eggs to be destroyed due to infection or exposure to H5/H7 LPAI; and * * * * * PO 00000 Frm 00009 Fmt 4702 Sfmt 4702 66639 7. Section 56.8 is amended as follows: a. In paragraph (a) introductory text, by removing the word ‘‘may’’ and adding the word ‘‘shall’’ in its place; and ■ b. By revising paragraph (b). The revision reads as follows: ■ ■ § 56.8 Conditions for payment. * * * * * (b)(1) If indemnity for the destroyed poultry or eggs is being provided for 100 percent of eligible costs under § 56.3(b), the Administrator may pay contractors eligible for indemnity under this section 100 percent of the amount determined in paragraph (a) of this section. (2) If indemnity for the destroyed poultry or eggs is being provided for 25 percent of eligible costs under § 56.3(b), the Administrator may pay contractors eligible for indemnity 25 percent of the amount determined in paragraph (a) of this section. * * * * * § 56.9 [Amended] 8. Section 56.9 is amended as follows: a. In paragraph (a), by removing the citation ‘‘§ 56.4(a)(1)’’ and adding the citation ‘‘§ 56.4(a)’’ in its place; and ■ b. In paragraph (b), by adding the words ‘‘and/or compensation’’ after the word ‘‘indemnity’’ both times it appears. ■ ■ § 56.10 [Amended] 9. In § 56.10, paragraph (a) introductory text is amended by adding the words ‘‘and/or compensation’’ after the word ‘‘indemnity’’. ■ PART 145—NATIONAL POULTRY IMPROVEMENT PLAN FOR BREEDING POULTRY 10. The authority citation for part 145 continues to read as follows: ■ Authority: 7 U.S.C. 8301–8317; 7 CFR 2.22, 2.80, and 371.4. 11. Section 145.1 is amended as follows: ■ a. By revising the definition for Avian influenza; ■ b. By adding a definition for Newcastle disease in alphabetical order; and ■ c. By revising the definition for NPIP Program Standards. The revisions and addition read as follows: ■ § 145.1 Definitions. * * * * * 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 E:\FR\FM\05DEP1.SGM 05DEP1 66640 Federal Register / Vol. 84, No. 234 / Thursday, December 5, 2019 / Proposed Rules pathogenicity index (IVPI) greater than 1.2 (or as an alternative at least 75 percent mortality). * * * * * 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 Cterminus 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 above 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. * * * * * ■ 12. Section 145.7 is revised to read as follows: jbell on DSKJLSW7X2PROD with PROPOSALS § 145.7 Specific provisions for participating dealers. Dealers in hatching eggs, newly hatched poultry, or started poultry shall comply with the provisions in this part (within the NPIP Program Standards document, Program Standard C applies to hatcheries; alternatives to the program standards may also be approved by the Administrator under § 147.53). ■ 13. Section 145.14 is amended as follows: ■ a. By revising paragraphs (d)(1) and (2) introductory text; and ■ b. By adding paragraph (e). The revisions and addition read as follows: § 145.14 Testing. * * * * * (d) * * * (1) Antibody detection tests—(i) ELISA test. (A) The ELISA test must be VerDate Sep<11>2014 17:13 Dec 04, 2019 Jkt 250001 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) 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. * * * * * (e) For Newcastle Disease (ND). The official tests for ND are serological tests for antibody detection or molecularbased tests for antigen detection. * * * * * § 145.23 [Amended] 14. Section 145.23 is amended as follows: ■ a. By removing paragraphs (d)(1)(vi) and (vii) and redesignating paragraphs (d)(1)(viii) and (ix) as paragraphs (d)(1)(vi) and (vii), respectively; and ■ b. By removing paragraph (d)(3) and redesignating paragraphs (d)(4) and (5) as paragraphs (d)(3) and (4), respectively. ■ § 145.24 [Amended] 15. In § 145.24, paragraph (a)(1)(i) is amended by removing ‘‘§ 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)’’ and adding ‘‘§§ 145.23(b)(3)(i) through (vii), 145.33(b)(3)(i) through (vii), ■ PO 00000 Frm 00010 Fmt 4702 Sfmt 4702 145.43(b)(3)(i) through (vi), 145.53(b)(3)(i) through (vii), 145.73(b)(2)(i), 145.83(b)(2)(i), 145.93(b)(3)(i) through (vii), and 145.103(b)(3)(i) through (ix)’’ in its place. ■ 16. Section 145.33 is amended as follows: ■ a. In paragraph (l)(1)(ii), by removing the number ‘‘30’’ and adding the number ‘‘15’’ in its place; and ■ b. By revising paragraph (l)(2). The revision reads as follows: § 145.33 Terminology and classification; flocks and products. * * * * * (l) * * * (2) During each 90-day period, all multiplier spent fowl, up to a maximum of 30, must be tested and found negative for avian influenza within 21 days prior to movement to slaughter. * * * * * § 145.34 [Amended] 17. In § 145.34, paragraph (a)(1)(i) is amended by removing ‘‘§ 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)’’ and adding ‘‘§§ 145.23(b)(3)(i) through (vii), 145.33(b)(3)(i) through (vii), 145.43(b)(3)(i) through (vi), 145.53(b)(3)(i) through (vii), 145.73(b)(2)(i), 145.83(b)(2)(i), 145.93(b)(3)(i) through (vii), and 145.103 (b)(3)(i) through (ix)’’ in its place. ■ 18. Section 145.43 is amended by adding paragraph (h) to read as follows: ■ § 145.43 Terminology and classification; flocks and products. * * * * * (h) U.S. Newcastle Disease Clean. The program in this paragraph (h) is intended to be the basis from which the breeding-hatchery industry may conduct a program for the prevention and control of Newcastle disease. It is intended to determine the presence of Newcastle disease in primary breeding turkeys through vaccination and/or monitoring of each participating breeding flock. A flock and the hatching eggs and poults produced from it will qualify for the classification in this paragraph (h) when the Official State Agency determines that they have met the following requirements: (1) It is a primary breeding flock that is either: (i) Vaccinated for Newcastle disease using USDA-licensed vaccines and response to vaccination is serologically monitored using an approved test as E:\FR\FM\05DEP1.SGM 05DEP1 jbell on DSKJLSW7X2PROD with PROPOSALS Federal Register / Vol. 84, No. 234 / Thursday, December 5, 2019 / Proposed Rules 66641 described in § 145.14 when more than 4 months of age, and meets the criteria in paragraph (h)(2) of this section to retain classification; or (ii) Unvaccinated for Newcastle disease, in which a minimum of 30 birds have tested negative to ND using an approved test as described in § 145.14 when more than 4 months of age and meets the criteria in paragraph (h)(3) of this section to retain classification. (2) To retain the classification in this paragraph (h), for vaccinated flocks: (i) Vaccines for ND must be USDAlicensed vaccines administered during early stages of development through rearing, and inactivated vaccines as final vaccination prior to the onset of egg production; and (ii) The flock has been monitored for antibody response using approved serological tests as listed in § 145.14 and the results are compatible with immunological response against ND vaccination; and (iii) Testing must include a minimum of 30 birds with a serologic monitoring program when more than 4 months of age and prior to the onset of production and not longer than every 90 days thereafter. (3) To retain the classification in this paragraph (h) for unvaccinated flocks: (i) A minimum of 30 birds per flock must test negative using an approved test in § 145.14 at intervals of 90 days; or (ii) A sample of fewer than 30 birds may be tested, and found negative, at any one time if all pens are equally represented and a total of 30 birds is tested within each 90-day period; and (iii) During each 90-day period, all primary spent fowl, up to a maximum of 30, must test negative to ND within 21 days prior to movement to slaughter. (4) Newcastle disease must be a disease reportable to the responsible State authority (State veterinarian, etc.) by all licensed veterinarians. To accomplish this, all laboratories (private, State, and university laboratories) that perform diagnostic procedures on poultry must examine all submitted cases of unexplained respiratory disease, egg production drops, and mortality for ND. * * * * * 145.33(b)(3)(i) through (vii), 145.43(b)(3)(i) through (vi), 145.53(b)(3)(i) through (vii), 145.73(b)(2)(i), § 145.83(b)(2)(i), 145.93(b)(3)(i) through (vii), and 145.103(b)(3)(i) through (ix)’’ in this place. ■ 20. Section 145.45 is amended as follows: ■ a. By revising paragraph (a) introductory text; ■ b. In paragraph (a)(1) introductory text, by adding the words ‘‘and ND’’ after the word ‘‘AI’’ each time it appears; ■ c. In paragraph (a)(1)(i): ■ i. By adding the words ‘‘and ND Clean in accordance with § 145.43(h)’’ after the citation ‘‘§ 145.43(g)’’; ■ ii. By adding the words ‘‘and ND’’ after the words ‘‘official tests for AI’’ and adding the words ‘‘and (e)’’ after the citation ‘‘§ 145.14(d)’’; and ■ iii. By removing the word ‘‘AIrelated’’ and adding the words ‘‘AI and ND-related’’ in its place; ■ d. In paragraphs (a)(1)(iii) introductory text, (a)(1)(iii)(B) and (E), and (a)(1)(v), by adding the words ‘‘and ND’’ after the word ‘‘AI’’ each time it appears; ■ e. In paragraph (a)(1)(vi), by adding the words ‘‘and ND’’ after the word ‘‘Influenza’’; ■ f. In paragraph (a)(2)(iii): ■ i. By removing the words ‘‘Clean classification’’ and adding the words ‘‘and ND Clean classifications’’ in their place; ■ ii. By adding the words ‘‘and ND’’ after the word ‘‘AI’’ both times it appears; and ■ iii. By removing the words ‘‘avian influenza surveillance’’ and adding the words ‘‘avian influenza and ND surveillance’’ in their place; ■ g. In paragraph (a)(3)(iii), by adding the words ‘‘and ND’’ after the word ‘‘Influenza’’; ■ h. In paragraph (a)(3)(iv), by adding the words ‘‘and ND Clean program as described in § 145.43(h)’’ after the citation ‘‘§ 145.43(g)’’; and ■ i. In paragraph (a)(3)(vii), by adding the words ‘‘and (h)’’ after the citation ‘‘145.43(g)’’. The revision reads as follows: primary breeding-hatchery company that is free of H5/H7 avian influenza (AI) and ND. This compartment has the purpose of protecting the defined subpopulation and avoiding the introduction and spread of H5/H7 AI and ND within that subpopulation 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: * * * * * ■ 21. The heading for subpart E, consisting of §§ 145.51 through 146.54, is revised to read as follows: § 145.45 Terminology and classification; compartments. § 145.44 (a) US H5/H7 AI and ND Clean Compartment. The program in this section is intended to be the basis from which the primary turkey breedinghatchery industry may demonstrate the existence and implementation of a program that has been approved by the Official State Agency and APHIS to establish a compartment consisting of a Participating flocks of hobbyist and exhibition poultry, raised-for-release waterfowl, and the eggs, chicks, started, and mature poultry produced from them shall comply with the applicable general provisions of subpart A of this part and the special provisions of this subpart. The special provisions that apply to meat-type waterfowl flocks are found in subpart I of this part. The special provisions that apply to game [Amended] 19. In § 145.44, paragraph (a)(1)(i) is amended by removing ‘‘§ 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)’’ and adding ‘‘§§ 145.23(b)(3)(i) through (vii), ■ VerDate Sep<11>2014 17:13 Dec 04, 2019 Jkt 250001 PO 00000 Frm 00011 Fmt 4702 Sfmt 4702 Subpart E—Special Provisions for Hobbyist and Exhibition Poultry, and Raised-for-Release Waterfowl Breeding Flocks and Products 22. Section 145.51 is amended as follows: ■ a. By removing the definition for Game birds; ■ b. By adding, in alphabetical order, definitions for Hobbyist poultry and Raised-for-release waterfowl; and ■ c. By removing the definition for Waterfowl. The additions read as follows: ■ § 145.51 Definitions. * * * * * Hobbyist poultry. Domesticated fowl which are bred for the purposes of meat and/or egg production on a small scale as determined by the Official State Agency. Raised-for-release waterfowl. Domesticated fowl that normally swim, such as ducks and geese, grown under confinement for the primary purpose of producing eggs, chicks, started, or mature birds for release on game preserves or in the wild. ■ 23. Section 145.52 is amended as follows: ■ a. By revising the introductory text; ■ b. In paragraph (c), by removing the words ‘‘in open air facilities’’; and ■ c. By adding paragraph (f). The revision and addition read as follows: § 145.52 E:\FR\FM\05DEP1.SGM Participation. 05DEP1 66642 Federal Register / Vol. 84, No. 234 / Thursday, December 5, 2019 / Proposed Rules bird flocks are found in subpart J of this part. * * * * * (f) All participating raised-for-release waterfowl flocks, regardless of whether they are breeders or non-breeders, shall be enrolled under this subpart. ■ 24. Section 145.53 is amended as follows: ■ a. In paragraph (b)(5), by removing the words ‘‘exhibition waterfowl or’’; and ■ b. By revising paragraph (f). The revision reads as follows: § 145.53 Terminology and classification; flocks and products. jbell on DSKJLSW7X2PROD with PROPOSALS * * * * * (f) U.S. Salmonella Monitored. The program in this paragraph (f) is intended to be the basis from which the breedinghatching industry may conduct a program for the prevention and control of salmonellosis. It is intended to reduce the incidence of Salmonella organisms in hatching eggs and day-old poultry through an effective and practical sanitation and testing program at the breeder farm and in the hatchery. This will afford other segments of the poultry industry an opportunity to reduce the incidence of Salmonella in their products. The following requirements must be met for a flock or hatchery to be eligible for the classification in this paragraph (f) as determined by the Official State Agency: (1) Hatcheries must be kept in a sanitary condition as applicable and as outlined in § 145.6 (within the NPIP Program Standards document, Program Standard C applies to hatcheries; alternatives to the program standards may also be approved by the Administrator under § 147.53). (2) An Authorized Agent shall collect and submit to an authorized laboratory: (i) A minimum of five samples from the hatchery at least every 30 days while in operation. These samples may include: Hatchery debris, swabs from hatchers, setters, hatchery environment, hatchery equipment, sexing tables and belts, meconium, chick box papers, hatching trays, or chick transfer devices. Samples will be examined bacteriologically at an authorized laboratory for Salmonella; and (ii) Annual environmental samples from each pullet and breeder farm in accordance with this section (within the NPIP Program Standards document, Program Standard B applies to bacteriological examination procedures; alternatives to the program standards may also be approved by the Administrator under § 147.53). Samples will be examined bacteriologically at an authorized laboratory for Salmonella. VerDate Sep<11>2014 17:13 Dec 04, 2019 Jkt 250001 (3) If Salmonella is identified through this testing: (i) A qualified poultry health professional knowledgeable with the operation will be consulted and will: (A) Review test results to evaluate the Salmonella monitoring program. (B) Use the Salmonella monitoring program test results to develop appropriate and practical Salmonella intervention measures. (ii) [Reserved] (4) To claim products are of the classification in this paragraph (f), all products shall be derived from a farm or hatchery that meets the requirements of the classification. * * * * * § 145.54 [Amended] 25. In § 145.54, paragraph (a)(1)(i) is amended by removing ‘‘§ 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)’’ and adding ‘‘§§ 145.23(b)(3)(i) through (vii), 145.33(b)(3)(i) through (vii), 145.43(b)(3)(i) through (vi), 145.53(b)(3)(i) through (vii), 145.73(b)(2)(i), 145.83(b)(2)(i), 145.93(b)(3)(i) through (vii), and 145.103(b)(3)(i) through (ix)’’ in its place. ■ 26. Section 145.73 is amended as follows: ■ a. By removing paragraphs (d)(1)(vi) and (vii) and redesignating paragraphs (d)(1)(viii) and (ix) as paragraphs (d)(1)(vi) and (vii), respectively; ■ b. By removing paragraph (d)(3) and redesignating paragraphs (d)(4) and (5) as paragraphs (d)(3) and (4), respectively; and ■ c. By adding paragraph (h). The addition reads as follows: ■ § 145.73 Terminology and classification; flocks and products. * * * * * (h) U.S. Newcastle Disease Clean. The program in this paragraph (h) is intended to be the basis from which the breeding-hatchery industry may conduct a program for the prevention and control of Newcastle disease. It is intended to determine the presence of Newcastle disease in primary breeding chickens through vaccination and/or monitoring of each participating breeding flock. A flock and the hatching eggs and chicks produced from it will qualify for the classification in this paragraph (h) when the Official State Agency determines that they have met the following requirements: (1) It is a primary breeding flock that is either: PO 00000 Frm 00012 Fmt 4702 Sfmt 4702 (i) Vaccinated for Newcastle disease using USDA-licensed vaccines and response to vaccination is serologically monitored using an approved test as described in § 145.14 when more than 4 months of age and meets the criteria in paragraph (h)(2) of this section to retain classification; or (ii) Unvaccinated for Newcastle disease, in which a minimum of 30 birds have tested negative to ND using an approved test as described in § 145.14 when more than 4 months of age and meets criteria in paragraph (h)(3) of this section to retain classification. (2) To retain the classification in this paragraph (h), for vaccinated flocks: (i) Vaccines for ND must be USDAlicensed vaccines administered during early stages of development through rearing, and inactivated vaccines as final vaccination prior to the onset of egg production; and (ii) The flock has been monitored for antibody response using approved serological tests as listed in § 145.14 and the results are compatible with immunological response against ND vaccination; and (iii) Testing must include a minimum of 30 birds with a serologic monitoring program when more than 4 months of age and prior to the onset of production and not longer than every 90 days thereafter. (3) To retain the classification in this paragraph (h) for unvaccinated flocks: (i) A minimum of 30 birds per flock must test negative using an approved test as described in § 145.14 at intervals of 90 days; or (ii) A sample of fewer than 30 birds may be tested, and found negative, at any one time if all pens are equally represented and a total of 30 birds is tested within each 90-day period; and (iii) During each 90-day period, all primary spent fowl, up to a maximum of 30, must test negative to ND within 21 days prior to movement to slaughter. (4) Newcastle disease must be a disease reportable to the responsible State authority (State veterinarian, etc.) by all licensed veterinarians. To accomplish this, all laboratories (private, State, and university laboratories) that perform diagnostic procedures on poultry must examine all submitted cases of unexplained respiratory disease, egg production drops, and mortality for ND. ■ 27. Section 145.74 is amended as follows: ■ a. In paragraph (a) introductory text, by revising the paragraph heading, adding the words ‘‘and Newcastle disease (ND)’’ after the word ‘‘(AI)’’, and E:\FR\FM\05DEP1.SGM 05DEP1 Federal Register / Vol. 84, No. 234 / Thursday, December 5, 2019 / Proposed Rules adding the words ‘‘and ND’’ after the word ‘‘AI’’; ■ b. In paragraph (a)(1) introductory text, by adding the words ‘‘and ND’’ after the word ‘‘AI’’ each time it appears; ■ c. In paragraph (a)(1)(i): ■ i. By adding the words ‘‘and ND Clean in accordance with § 145.73(h)’’ after the words ‘‘in accordance with § 145.73(f)’’; ■ ii. By adding the words ‘‘and ND’’ after the words ‘‘official tests for AI’’ and adding the words ‘‘and (e)’’ after the citation ‘‘§ 145.14(d)’’; and ■ iii. By removing the word ‘‘AIrelated’’ and adding the words ‘‘AI and ND-related’’ in its place; ■ d. In paragraphs (a)(1)(iii), (a)(1)(iii)(B) and (E), and (a)(1)(v), by adding the words ‘‘and ND’’ after the word ‘‘AI’’ each time it appears; ■ e. In paragraph (a)(1)(vi), by adding the words ‘‘and ND’’ after the word ‘‘Influenza’’; ■ f. In paragraph (a)(2)(iii): ■ i. By removing the words ‘‘Clean classification’’ and adding the words ‘‘and ND Clean classifications’’ in their place; ■ ii. By adding the words ‘‘and ND’’ after the word ‘‘AI’’ both times it appears; and ■ iii. By removing the words ‘‘avian influenza surveillance’’ and adding the words ‘‘avian influenza and ND surveillance’’ in their place; ■ g. In paragraph (a)(3)(iii), by adding the words ‘‘and ND’’ after the word ‘‘Influenza’’; ■ h. In paragraph (a)(3)(iv), by adding the words ‘‘and ND Clean program as described in § 145.73(h)’’ after the citation ‘‘§ 145.73(f)’’; ■ i. In paragraph (a)(3)(vii), by adding the words ‘‘and (h)’’ after the citation ‘‘145.73(f); and ■ j. In paragraph (a)(4), by adding the words ‘‘and/or ND’’ after the word ‘‘AI’’ both times it appears. The revision reads as follows: jbell on DSKJLSW7X2PROD with PROPOSALS § 145.74 Terminology and classification; compartments. (a) U.S. Avian Influenza and Newcastle Disease Clean Compartment. * * * * * * * * ■ 28. Section 145.83 is amended as follows: ■ a. By removing paragraph (e)(1)(iv) and redesignating paragraphs (e)(1)(v) and (vi) as paragraphs (e)(1)(iv) and (v), respectively; and ■ b. By adding paragraph (h). The addition reads as follows: § 145.83 Terminology and classification; flocks and products. * * * VerDate Sep<11>2014 * * 17:13 Dec 04, 2019 Jkt 250001 (h) U.S. Newcastle Disease (ND) Clean. The program in this paragraph (h) is intended to be the basis from which the breeding-hatchery industry may conduct a program for the prevention and control of Newcastle disease. It is intended to determine the presence of Newcastle disease in primary breeding chickens through vaccination and/or monitoring of each participating breeding flock. A flock and the hatching eggs and chicks produced from it will qualify for the classification in this paragraph (h) when the Official State Agency determines that they have met the following requirements: (1) It is a primary breeding flock that is either: (i) Vaccinated for Newcastle disease using USDA-licensed vaccines and response to vaccination is serologically monitored using an approved test as described in § 145.14 when more than 4 months of age and meets the criteria in paragraph (h)(2) of this section to retain classification; or (ii) Unvaccinated for Newcastle disease, in which a minimum of 30 birds have tested negative to ND using an approved test as described in § 145.14 when more than 4 months of age and meets criteria in paragraph (h)(3) of this section to retain classification. (2) To retain the classification in this paragraph (h), for vaccinated flocks: (i) Vaccines for ND must be USDAlicensed vaccines administered during early stages of development through rearing, and inactivated vaccines as final vaccination prior to the onset of egg production; and (ii) The flock has been monitored for antibody response using approved serological tests as described in § 145.14 and the results are compatible with immunological response against ND vaccination; and (iii) Testing must include a minimum of 30 birds with a serologic monitoring program when more than 4 months of age and prior to the onset of production, and not longer than every 90 days thereafter. (3) To retain the classification in this paragraph (h) for unvaccinated flocks: (i) A minimum of 30 birds per flock must test negative using an approved test as described in § 145.14 at intervals of 90 days; or (ii) A sample of fewer than 30 birds may be tested, and found negative, at any one time if all pens are equally represented and a total of 30 birds is tested within each 90-day period; and (iii) During each 90-day period, all primary spent fowl, up to a maximum of 30, must test negative to ND within 21 days prior to movement to slaughter. PO 00000 Frm 00013 Fmt 4702 Sfmt 4702 66643 (4) Newcastle disease must be a disease reportable to the responsible State authority (State veterinarian, etc.) by all licensed veterinarians. To accomplish this, all laboratories (private, State, and university laboratories) that perform diagnostic procedures on poultry must examine all submitted cases of unexplained respiratory disease, egg production drops, and mortality for ND. ■ 29. Section 145.84 is amended as follows: ■ a. In paragraph (a) introductory text, by revising the heading, adding the words ‘‘and Newcastle disease (ND)’’ after the words ‘‘influenza (AI)’’, and adding the words ‘‘and ND’’ after the words ‘‘H5/H7 AI’’; ■ b. In paragraph (a)(1) introductory text, by adding the words ‘‘and ND’’ after the word ‘‘AI’’ each time it appears; ■ c. By revising paragraph (a)(1)(i); ■ d. In paragraphs (a)(1)(iii) introductory text, (a)(1)(iii)(B) and (E), and (a)(1)(v), by adding the words ‘‘and ND’’ after the word ‘‘AI’’ each time it appears; ■ e. In paragraph (a)(1)(vi), by adding the words ‘‘and ND’’ after the word ‘‘Influenza’’; ■ f. In paragraph (a)(2)(iii): ■ i. Removing the words ‘‘Clean classification’’ and adding the words ‘‘and ND Clean classifications’’ in their place; ■ ii. Adding the words ‘‘and ND’’ after the word ‘‘AI’’ both times it appears; and ■ iii. Removing the words ‘‘avian influenza surveillance’’ and adding the words ‘‘avian influenza and ND surveillance’’ in their place; ■ g. In paragraph (a)(3)(iv), by adding the words ‘‘and ND Clean program as described in § 145.83(h)’’ after the citation ‘‘§ 145.83(g)’’; and ■ h. In paragraph (a)(3)(vii), by adding the words ’’ and (h)’’ after the citation ‘‘145.83(g)’’. The revisions read as follows: § 145.84 Terminology and classification; compartments. (a) U.S. Avian Influenza and Newcastle Disease Clean Compartment. * * * (1) * * * (i) Definition and description of the subpopulation of birds and their health status. All birds included in the compartment must be U.S. Avian Influenza Clean in accordance with § 145.83(g) and ND Clean in accordance with § 145.83(h). 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 E:\FR\FM\05DEP1.SGM 05DEP1 66644 Federal Register / Vol. 84, No. 234 / Thursday, December 5, 2019 / Proposed Rules 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 and ND, as described in § 145.14(d) and (e), must be conducted in State or Federal laboratories or in NPIP authorized laboratories that meet the minimum standards described in § 147.52 of this subchapter. In addition, the company must provide to the Service upon request any relevant historical and current H5/H7 AI and ND-related data for reference regarding surveillance for the disease and the health status of the compartment. Upon request, the Official State Agency may provide such data for other commercial poultry populations located in the State. * * * * * § 145.94 [Amended] 30. In § 145.94, paragraph (a)(1)(i) is amended by removing the word ‘‘and’’ and adding the words ‘‘, and 145.103(b)(3)(i) through (ix)’’ after the words ‘‘145.93(b)(3)(i) through (vii)’’. ■ 31. Subpart J, consisting of §§ 145.101 through 145.104, is added to read as follows: ■ Subpart J—Special Provisions for Egg/ Meat-Type Game Bird and Raised-forRelease Game Bird Breeding Flocks and Products Sec. 145.101 Definitions. 145.102 Participation. 145.103 Terminology and classification; flocks and products. 145.104 Terminology and classification; States. Subpart J—Special Provisions for Egg/ Meat-Type Game Bird and Raised-forRelease Game Bird Breeding Flocks and Products jbell on DSKJLSW7X2PROD with PROPOSALS § 145.101 Definitions. Except where the context otherwise requires, for the purposes of this subpart the following terms shall be construed, respectively, to mean: Egg/meat-type bird. Birds grown under confinement for the primary purpose of producing eggs and/or meat for human consumption. Game birds. Domesticated fowl such as pheasants, partridge, quail, grouse, and guineas, but not doves and pigeons. Raised-for-release bird. Birds grown under confinement for the primary purpose of producing eggs, chicks, started, or mature birds for release on game preserves or in the wild. § 145.102 Participation. Participating flocks of egg/meat-type game birds, raised-for-release game birds, and the products produced from VerDate Sep<11>2014 17:13 Dec 04, 2019 Jkt 250001 them shall comply with the applicable general provisions of subpart A of this part and the special provisions of this subpart. Participation is broken into the following categories of operation and products: (a) The categories for operation are: (1) Breeder. An individual or business that maintains a breeding flock for the purpose of producing eggs, chicks, started, or mature birds. A breeder that is also a hatchery and/or grower shall be categorized as a breeder. (2) Hatchery. A category of operations in which an individual or business does not have a breeding flock, but hatches eggs for the purpose of producing chicks, started, or mature birds. A hatchery that is also a grower shall be categorized as a hatchery. (3) Grower. A category of operations in which an individual or business does not have a breeding flock or hatchery, but raises birds for the purpose of selling started or mature birds. (4) Dealer. An individual or business that resells eggs, chicks, started, or mature birds. Products a dealer handles are typically resold within 30 days or less. (b) The categories for products are: (1) Egg. An egg laid by a female bird for the purpose of hatching a chick. (2) Chick. A bird that is newly hatched from an egg. (3) Started Bird. A bird that is between the age of a newly hatched chick and a mature bird. (4) Mature Bird. A bird that is fully colored and has reached the average maximum size specific to each species. (c) Products shall lose their identity under Plan terminology when not maintained by Plan participants under the conditions prescribed in § 145.5(a). (d) Hatching eggs produced by breeding flocks shall be nest clean, fumigated, or otherwise sanitized in accordance with part 147 of this subchapter. (e) It is recommended that gallinaceous flocks and waterfowl flocks be kept separate. (f) Any nutritive material provided to baby poultry must be free of the avian pathogens that are officially represented in the Plan disease classifications listed in § 145.10. (g) A flock of game birds that are not breeders, but are located on the same premise as game bird breeders, shall be covered under the same NPIP hatchery approval number as long as the appropriate testing requirements have been met. (h) All participating raised-for-release game bird flocks, regardless of whether they are breeders or non-breeders, shall be enrolled under this subpart. PO 00000 Frm 00014 Fmt 4702 Sfmt 4702 (i) A breeder, hatchery, or grower may also be a dealer without being categorized as a dealer. To resell products under the assigned NPIP number and avoid losing NPIP flock classifications, products must be purchased from an NPIP participant with equal or greater classifications or from a flock with equivalent or greater testing requirements under official supervision. (j) Subject to the approval of the Service and the Official State Agencies in the importing and exporting States, participating flocks may report poultry sales to importing States by using either VS Form 9–3, ‘‘Report of Sales of Hatching Eggs, Chicks, and Poults,’’ or by using an invoice form (9–3I) approved by the Official State Agency and the Service to identify poultry sales to clients. If the 9–3I form is used, the following information must be included on the form: (1) The form number ‘‘9–3I’’, printed or stamped on the invoice; (2) The seller name and address; (3) The date of shipment; (4) The invoice number; (5) The purchaser name and address; (6) The quantity of products sold; (7) Identification of the products by bird variety or by NPIP stock code as listed in the NPIP APHIS 91–55–078 appendix; and (8) The appropriate NPIP illustrative design in § 145.10. One of the designs in § 145.10(b) or (g) must be used. The following information must be provided in or near the NPIP design: (i) The NPIP State number and NPIP approval number; and (ii) The NPIP classification for which product is qualified (e.g., U.S. PullorumTyphoid Clean). § 145.103 Terminology and classification; flocks and products. Participating flocks, and the eggs, chicks, started, and mature birds produced from them, which have met the respective requirements specified in this section may be designated by the following terms and the corresponding designs illustrated in § 145.10. (a) [Reserved] (b) U.S. Pullorum-Typhoid Clean. A flock in which freedom from pullorum and typhoid has been demonstrated to the Official State Agency under the criteria in this paragraph (b). (See § 145.14 relating to the official blood test where applicable.): (1) It has been officially blood tested with either no reactors or reactors that, upon further bacteriological examination conducted in accordance with part 147 of this subchapter, fail to isolate S. pullorum or S. gallinarum. E:\FR\FM\05DEP1.SGM 05DEP1 jbell on DSKJLSW7X2PROD with PROPOSALS Federal Register / Vol. 84, No. 234 / Thursday, December 5, 2019 / Proposed Rules (2) It is a started or mature bird flock that meets the following specifications as determined by the Official State Agency and the Service: (i) The flock is located in a State where all persons performing poultry disease diagnostic services within the State are required to report to the Official State Agency within 48 hours the source of all poultry specimens from which S. pullorum or S. gallinarum is isolated; (ii) The flock is composed entirely of birds that originated from U.S. Pullorum-Typhoid Clean breeding flocks or from flocks that met equivalent requirements under official supervision; and (iii) The flock is located on a premises where a flock not classified as U.S. Pullorum-Typhoid Clean was located the previous year; Provided, That an Authorized Testing Agent must blood test up to 300 birds per flock, as described in § 145.14, if the Official State Agency determines that the flock has been exposed to pullorum-typhoid. In making determinations of exposure and setting the number of birds to be blood tested, the Official State Agency shall evaluate the results of any blood tests, described in § 145.14(a)(1), that were performed on an unclassified flock located on the premises during the previous year; the origins of the unclassified flock; and the probability of contacts between the flock for which qualification is being sought and infected wild birds, contaminated feed or waste, or birds, equipment, supplies, or personnel from flocks infected with pullorum-typhoid. (3) It is a breeding flock that originated from U.S. Pullorum-Typhoid Clean breeding flocks or from flocks that met equivalent requirements under official supervision, and in which a sample of 300 birds from flocks of more than 300, and each bird in flocks of 300 or less, has been officially tested for pullorum-typhoid: Provided, That a bacteriological examination monitoring program or serological examination monitoring program for game birds acceptable to the Official State Agency and approved by the Service may be used in lieu of annual blood testing: And provided further, That it is located in a State in which it has been determined by the Service that: (i) All hatcheries within the State are qualified as ‘‘National Plan Hatcheries’’ or have met equivalent requirements for pullorum-typhoid control under official supervision; (ii) All hatchery supply flocks within the State, are qualified as U.S. Pullorum-Typhoid Clean or have met equivalent requirements for pullorum- VerDate Sep<11>2014 17:13 Dec 04, 2019 Jkt 250001 typhoid control under official supervision: Provided, That if other domesticated fowl, except waterfowl, are maintained on the same premises as the participating flock, freedom from pullorum-typhoid infection shall be demonstrated by an official blood test of each of these fowl; (iii) All shipments of products other than U.S. Pullorum-Typhoid Clean, or equivalent, into the State are prohibited; (iv) All persons performing poultry disease diagnostic services within the State are required to report to the Official State Agency within 48 hours the source of all poultry specimens from which S. pullorum or S. gallinarum is isolated; (v) All reports of any disease outbreak involving a disease covered under the Plan are promptly followed by an investigation by the Official State Agency to determine the origin of the infection; Provided, That if the origin of the infection involves another State, or if there is exposure to poultry in another State from the infected flock, then the National Poultry Improvement Plan will conduct an investigation; (vi) All flocks found to be infected with pullorum or typhoid are quarantined until marketed or destroyed under the supervision of the Official State Agency, or until subsequently blood tested, following the procedure for reacting flocks as contained in § 145.14(a)(5), and all birds fail to demonstrate pullorum or typhoid infection; (vii) All poultry, including exhibition, exotic, and game birds, but excluding waterfowl, going to public exhibition shall come from U.S. Pullorum-Typhoid Clean or equivalent flocks, or have had a negative pullorum-typhoid test within 90 days of going to public exhibition; and (viii) The flock is located in a State in which pullorum disease or fowl typhoid is not known to exist nor to have existed in hatchery supply flocks within the State during the preceding 24 months. (ix) Discontinuation of any of the conditions or procedures described in paragraphs (b)(3)(i) through (viii) of this section, or the occurrence of repeated outbreaks of pullorum or typhoid in poultry breeding flocks within or originating within the State shall be grounds for the Service to revoke its determination that such conditions and procedures have been met or complied with. Such action shall not be taken until a thorough investigation has been made by the Service and the Official State Agency has been given an opportunity to present its views. (c) U.S. H5/H7 Avian Influenza Clean. The program in this paragraph (c) is PO 00000 Frm 00015 Fmt 4702 Sfmt 4702 66645 intended to be the basis from which the game bird industry may conduct a program for the prevention and control of the H5 and H7 subtypes of avian influenza. It is intended to determine the presence of the H5 and H7 subtypes of avian influenza in game bird flocks through routine surveillance of each participating flock. A flock or premise, and the hatching eggs, chicks, started, and mature birds produced from it, will qualify for the classification in this paragraph (c) when the Official State Agency determines that it has met the following requirements: (1) It is a flock in which a minimum of 30 birds has been tested negative to the H5 and H7 subtypes of avian influenza as provided in § 145.14(d) when more than 4 months of age. To retain the classification in this paragraph (c): (i) A sample of at least 30 birds must be tested negative at intervals of 90 days; or (ii) A sample of fewer than 30 birds may be tested, and found to be negative, at any one time if all pens are equally represented and a total of 30 birds are tested within each 90-day period. (2) For participants with non-breeding flocks retained for raised-for-release or other purposes on the same premises as a breeding flock, a representative sample of at least 30 birds from the participating premise must be tested negative to the H5 and H7 subtypes of avian influenza as provided in § 145.14(d) when more than 4 months of age, every 90 days. (d) U.S. Salmonella Monitored. The program in this paragraph (d) is intended to be the basis from which the game bird industry may conduct a program for the prevention and control of salmonellosis. It is intended to reduce the incidence of Salmonella organisms in day-old poultry through an effective and practical sanitation program in the hatchery. This will afford other segments of the poultry industry an opportunity to reduce the incidence of Salmonella in their products. The following requirements must be met for a flock to be of the classification in this paragraph (d): (1) An Authorized Agent shall collect a minimum of five environmental samples, e.g., chick papers, hatching trays, and chick transfer devices, from the hatchery at least every 30 days. Testing must be performed at an authorized laboratory. (2) To claim products are of the classification in this paragraph (d), all products shall be derived from a hatchery that meets the requirements of the classification. E:\FR\FM\05DEP1.SGM 05DEP1 66646 Federal Register / Vol. 84, No. 234 / Thursday, December 5, 2019 / Proposed Rules (3) The classification in this paragraph (d) may be revoked by the Official State Agency if the participant fails to follow recommended corrective measures. § 145.104 States. Terminology and classification; (a) U.S. Pullorum-Typhoid Clean State. (1) A State will be declared a U.S. Pullorum-Typhoid Clean State when it has been determined by the Service that: (i) The State is in compliance with the provisions contained in §§ 145.23(b)(3)(i) through (vii), 145.33(b)(3)(i) through (vii), 145.43(b)(3)(i) through (vi), 145.53(b)(3)(i) through (vii), 145.73(b)(2)(i), 145.83(b)(2)(i), 145.93(b)(3)(i) through (vii), and 145.103(b)(3)(i) through (ix). (ii) No pullorum disease or fowl typhoid is known to exist nor to have existed in hatchery supply flocks within the State during the preceding 12 months: Provided, That pullorum disease or fowl typhoid found within the preceding 24 months in waterfowl, exhibition poultry, and game bird breeding flocks will not prevent a State, which is otherwise eligible, from qualifying. (2) Discontinuation of any of the conditions described in paragraph (a)(1)(i) of this section, or repeated outbreaks of pullorum or typhoid occur in hatchery supply flocks described in paragraph (a)(1)(ii) of this section, or if an infection spreads from the originating premises, the Service shall have grounds to revoke its determination that the State is entitled to the classification in this paragraph (a). Such action shall not be taken until a thorough investigation has been made by the Service and the Official State Agency has been given an opportunity for a hearing in accordance with rules of practice adopted by the Administrator. (b) [Reserved] PART 146—NATIONAL POULTRY IMPROVEMENT PLAN FOR COMMERCIAL POULTRY 32. The authority citation for part 146 continues to read as follows: ■ jbell on DSKJLSW7X2PROD with PROPOSALS Authority: 7 U.S.C. 8301–8317; 7 CFR 2.22, 2.80, and 371.4. 33. Section 146.13 is amended as follows: ■ a. By revising paragraph (b)(1); and ■ b. In paragraph (b)(2) introductory text, by removing the words ‘‘matrix gene or protein’’ and adding the word ‘‘virus’’ in their place. The revision reads as follows: ■ VerDate Sep<11>2014 17:13 Dec 04, 2019 Jkt 250001 § 146.13 Testing. * * * * * (b) * * * (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, 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) 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. * * * * * ■ 34. Section 146.51 is revised to read as follows: § 146.51 Definitions. Except where the context otherwise requires, for the purposes of this subpart the following terms shall be construed, respectively, to mean: Egg/meat-type game birds. Domesticated fowl such as pheasants, partridge, quail, grouse, and guineas, but not doves and pigeons grown under confinement for the primary purposes of producing eggs and/or meat for human consumption. Egg/meat-type waterfowl. Domesticated ducks or geese grown under confinement for the primary purposes of producing eggs and/or meat for human consumption. Meat-type game bird slaughter plant. A meat-type game bird slaughter plant that is federally inspected or under State inspection that the U.S. Department of Agriculture’s Food Safety and Inspection Service has recognized as equivalent to Federal inspection. Meat-type waterfowl slaughter plant. A meat-type waterfowl slaughter plant that is federally inspected or under State PO 00000 Frm 00016 Fmt 4702 Sfmt 4702 inspection that the U.S. Department of Agriculture’s Food Safety and Inspection Service has recognized as equivalent to Federal inspection. Shift. The working period of a group of employees who are on duty at the same time. ■ 35. Section 146.52 is revised to read as follows: § 146.52 Participation. (a) Participating meat-type game bird slaughter plants, meat-type waterfowl slaughter plants, and egg-type game bird and egg-type waterfowl premises producing eggs for human consumption shall comply with the applicable general provisions of subpart A of this part and the special provisions of this subpart. (b) Meat-type game bird slaughter plants and Meat-type waterfowl slaughter plants that slaughter fewer than 50,000 birds annually are exempt from the special provisions of this subpart. (c) Egg-type game bird and egg-type waterfowl premises with fewer than 25,000 birds are exempt from the special provisions of this subpart. ■ 36. Section 146.53 is amended as follows: ■ a. In the introductory text, by adding the words ‘‘slaughter plants and’’ after the word ‘‘participating’’; ■ b. By revising paragraph (a) introductory text; ■ c. In paragraph (a)(1), by removing the words ‘‘commercial upland’’ and adding the word ‘‘meat-type’’ in their place and by removing the word ‘‘commercial’’ and adding the word ‘‘meat-type’’ in its place; ■ d. By revising paragraph (a)(2); ■ e. In paragraph (a)(3), by removing the words ‘‘commercial upland’’ and adding the word ‘‘meat-type’’ in their place and by removing the word ‘‘commercial’’ and adding the word ‘‘meat-type’’ in its place; ■ f. In paragraph (a)(4), by removing the words ‘‘a commercial upland’’ and adding the words ‘‘an egg-type’’ in their place and by adding the word ‘‘eggtype’’ after the words ‘‘game bird or’’. ■ g. In paragraph (a)(5), by removing the words ‘‘a commercial upland’’ and adding the words ‘‘an egg-type’’ in their place and by adding the word ‘‘eggtype’’ after the words ‘‘game bird or’’. ■ h. By removing and reserving paragraph (b). The revisions read as follows: § 146.53 Terminology and classification; slaughter plants and premises. * * * * * (a) U.S. H5/H7 Avian Influenza Monitored. The program in this E:\FR\FM\05DEP1.SGM 05DEP1 Federal Register / Vol. 84, No. 234 / Thursday, December 5, 2019 / Proposed Rules paragraph (a) is intended to be the basis from which the egg/meat-type game bird and egg/meat-type waterfowl 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 egg/meat-type game birds and egg/meat-type waterfowl through routine surveillance of each participating slaughter plant or, in the case of egg-producing flocks, the regular surveillance of these flocks. A slaughter plant or flock will qualify for the classification in this paragraph (a) when the Official State Agency determines that it has met one of the following requirements: * * * * * (2) It is a meat-type game bird slaughter plant or meat-type waterfowl slaughter plant that only accepts egg/ meat-type game birds or egg/meat-type waterfowl from flocks where a minimum of 11 birds per flock have been tested negative for the H5/H7 subtypes of avian influenza, as provided in § 146.13(b), no more than 21 days prior to slaughter; * * * * * § 147.48 Approval of conference recommendations by the Department. Proposals adopted by the official delegates will be recommended to the Department for incorporation into the provisions of the National Poultry Improvement Plan (NPIP) in parts 56, 145, and 146 of this chapter and this subpart. The Department 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. The Department will publish the recommendations in the Federal Register within 14 months following the NPIP Biennial Conference. ■ 40. In § 147.52, paragraph (b) is revised to read as follows: § 147.52 Authorized laboratories. * * * * * (b) Trained technicians. Testing procedures at all authorized laboratories must be run or overseen by a laboratory technician who every 4 years has attended, and satisfactorily completed, Service-approved laboratory workshops for Plan-specific diseases. * * * * * PART 147—AUXILIARY PROVISIONS ON NATIONAL POULTRY IMPROVEMENT PLAN Done in Washington, DC, this 28th day of October 2019. Kevin Shea, Administrator, Animal and Plant Health Inspection Service. 37. The authority citation for part 147 continues to read as follows: [FR Doc. 2019–23973 Filed 12–4–19; 8:45 am] ■ BILLING CODE 3410–34–P Authority: 7 U.S.C. 8301–8317; 7 CFR 2.22, 2.80, and 371.4. 38. Section 147.45 is revised to read as follows: SMALL BUSINESS ADMINISTRATION ■ jbell on DSKJLSW7X2PROD with PROPOSALS § 147.45 13 CFR Part 124 Official delegates. Each cooperating State shall be entitled to one official delegate for each of the programs prescribed in parts 145 and 146 of this subchapter 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 members and be certified by the Official State Agency. It is recommended but not required that the official delegates be Plan participants. Individuals may be allowed to be an official delegate or alternate delegate for up to three States in which that delegate has flocks or is a plan participant with acknowledgement and approval of the Official State Agencies. Each official delegate shall endeavor to obtain, prior to the Conference, the recommendations of industry members of their State with respect to each proposed change. ■ 39. Section 147.48 is revised to read as follows: VerDate Sep<11>2014 17:13 Dec 04, 2019 Jkt 250001 Tribal Consultations for Consolidation of Mentor Prote´ge´ Programs and Other Government Contracting Amendments (RIN 3245–AG94) U.S. Small Business Administration. ACTION: Notice of tribal consultation meetings. AGENCY: The U.S. Small Business Administration (SBA) announces that it is holding tribal consultation meetings in Minneapolis, Minnesota, Anchorage, Alaska, Albuquerque, New Mexico, and Oklahoma City, Oklahoma concerning the proposed revisions to the 8(a) Business Development (BD) program regulations. Testimony presented at these tribal consultations will become part of the administrative record for SBA’s consideration when the Agency deliberates on approaches to changes in the regulations pertaining to the 8(a) BD program. SUMMARY: PO 00000 Frm 00017 Fmt 4702 Sfmt 4702 66647 The Tribal Consultation meeting dates are as follows: 1. Tuesday, December 10, 2019, 10:00 a.m. to 2:00 p.m. (CST), Minneapolis, Minnesota. The pre-registration deadline for this Tribal Consultation meeting is December 6, 2019. 2. Wednesday, January 8, 2020, 10:00 a.m. to 4:00 p.m. (AKST), Anchorage, Alaska. The pre-registration deadline for this Tribal Consultation meeting is January 2, 2020. 3. Tuesday, January 14, 2020, 10:00 a.m. to 2:00 p.m. (MST), Albuquerque, New Mexico. The pre-registration deadline for this Tribal Consultation meeting is January 7, 2020. 4. Thursday, January 16, 2020, 10:00 a.m. to 2:00 p.m. (CST), Oklahoma City, Oklahoma. The pre-registration deadline for this Tribal Consultation meeting is January 9, 2020. ADDRESSES: 1. The Tribal Consultation meeting in Minneapolis, Minnesota will be held at the SBA Minnesota District Office, Training Center, 330 Second Avenue South, Minneapolis, MN 55401. 2. The Tribal Consultation meeting in Anchorage, Alaska will be held at the Z.J. Loussac Public Library, 3600 Denali Street, Anchorage, AK 99503. 3. The Tribal Consultation meeting in Albuquerque, New Mexico will be held at the Indian Pueblo Cultural Center, 2401 12th Street NW, Albuquerque, New Mexico 87104. 4. The Tribal Consultation meeting in Oklahoma City, Oklahoma will be held at the Francis Tuttle Technology Center, Corporate Training Center Building, 12777 North Rockwell Avenue, Oklahoma City, OK 73142. 5. Send pre-registration requests to attend and/or testify to Chequita Carter of SBA’s Office of Native American Affairs, U.S. Small Business Administration, 409 3rd Street SW, Washington, DC 20416; Chequita.Carter@sba.gov; or Facsimile to (202) 481–2177. 6. You may submit comments, identified by RIN 3245–AG94, by any of the following methods: • Federal eRulemaking Portal: http:// www.regulations.gov and follow the instructions for submitting comments. • Mail (for paper, disk, or CD–ROM submissions): To Brenda Fernandez, Office of Procurement Policy and Liaison, U.S. Small Business Administration, 409 3rd Street SW, Washington, DC 20416; or Brenda.Fernandez@sba.gov. Instructions: All submissions received must include the agency name and docket number or Regulatory Information Number (RIN) for this DATES: E:\FR\FM\05DEP1.SGM 05DEP1

Agencies

[Federal Register Volume 84, Number 234 (Thursday, December 5, 2019)]
[Proposed Rules]
[Pages 66631-66647]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-23973]


========================================================================
Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of 
the proposed issuance of rules and regulations. The purpose of these 
notices is to give interested persons an opportunity to participate in 
the rule making prior to the adoption of the final rules.

========================================================================


Federal Register / Vol. 84, No. 234 / Thursday, December 5, 2019 / 
Proposed Rules

[[Page 66631]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Parts 56, 145, 146, and 147

[Docket No. APHIS-2018-0062]
RIN 0579-AE49


National Poultry Improvement Plan and Auxiliary Provisions

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Proposed rule.

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SUMMARY: We are proposing to amend the regulations governing the 
National Poultry Improvement Plan (NPIP). These amendments would 
establish a U.S. Newcastle Disease Clean program within the NPIP, 
create an NPIP subpart specific to game birds, revise testing 
requirements, and clarify existing provisions of the regulations. We 
are also proposing to amend the regulations concerning the payment of 
indemnity and compensation for low pathogenic avian influenza to 
reflect current policy and operational practices, and to allow NPIP 
voting delegates to represent multiple States during the Biennial 
Conferences. These proposed changes were voted on and approved by the 
voting delegates at the NPIP's 2018 National Plan Conference.

DATES: We will consider all comments that we receive on or before 
February 3, 2020.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2018-0062.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2018-0062, Regulatory Analysis and Development, PPD, 
APHIS, Station 3A-03.8, 4700 River Road, Unit 118, Riverdale, MD 20737-
1238.
    Supporting documents and any comments we receive on this docket may 
be viewed at http://www.regulations.gov/#!docketDetail;D=APHIS-2018-
0062 or in our reading room, which is located in Room 1141 of the USDA 
South Building, 14th Street and Independence Avenue SW, Washington, DC. 
Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through 
Friday, except holidays. To be sure someone is there to help you, 
please call (202) 799-7039 before coming.

FOR FURTHER INFORMATION CONTACT: Dr. Elena Behnke, DVM, Senior 
Coordinator, National Poultry Improvement Plan, VS, APHIS, USDA, 1506 
Klondike Road, Suite 101, Conyers, GA 30094-5104; (770) 922-3496.

SUPPLEMENTARY INFORMATION:

Background

    The National Poultry Improvement Plan (NPIP, also referred to below 
as ``the Plan'') is a cooperative Federal-State-industry mechanism for 
controlling certain poultry diseases. The Plan consists of a variety of 
programs intended to prevent and control poultry diseases. 
Participation in all Plan programs is voluntary, but breeding flocks, 
hatcheries, and dealers must first qualify as ``U.S. Pullorum-Typhoid 
Clean'' as a condition for participating in the other Plan programs.
    The Plan identifies States, independent flocks, hatcheries, 
dealers, and slaughter plants that meet certain disease control 
standards specified in the Plan's various programs. As a result, 
customers can buy poultry that has tested clean of certain diseases or 
that has been produced under disease-prevention conditions.
    The regulations in 9 CFR parts 56, 145, 146, and 147 (referred to 
below as the regulations) contain the provisions of the Plan. The 
Animal and Plant Health Inspection Service (APHIS) amends these 
provisions from time to time to incorporate new scientific information 
and technologies within the Plan, and to ensure the plan reflects 
changes to the poultry industry itself. The changes we are proposing, 
which are discussed below, were approved by the voting delegates at the 
Plan's 2018 Biennial Conference.
    Participants and voting delegates at the Biennial Conference 
represented the poultry industry, flock owners, breeders, hatchery men, 
slaughter plants, poultry veterinarians, diagnostic laboratory 
personnel, Official State Agencies from cooperating States, and other 
poultry industry affiliates. The proposed amendments are discussed in 
the order they would appear in the regulations.

Proposed Amendments to Part 56

Definitions

    The terms H5/H7 LPAI exposed and H5/H7 LPAI infection (infected) 
are currently defined in Sec.  56.1 of the regulations in a manner that 
describes the risks or effects of poultry being exposed to or 
contracting the virus.
    The current definition of H5/H7 LPAI exposed provides that all 
birds or poultry associated with H5/H7 infected birds or poultry, 
whether it is via excrement or other materials, are automatically 
placed in the exposed category. This could be construed to suggest that 
an exposed flock is potentially infectious because the birds in the 
flock have had contact with the virus in some manner. However, this is 
not the case. Although ``exposed'' birds have been exposed to the 
virus, they are no longer shedding the virus and no longer considered 
to be potentially infectious. As such, they can go to slaughter to be 
controlled marketed, instead of being depopulated. Therefore, we are 
proposing to amend the terms and definitions of H5/H7 LPAI infection 
(infected) and H5/H7 LPAI exposed.
    The new terms would be H5/H7 LPAI virus exposed (non-infectious) 
and H5/H7 LPAI virus actively infected (infectious). We are proposing 
to define H5/H7 LPAI virus exposed (non-infectious) in the following 
way. Poultry would be considered to be exposed (non-infectious) to H5/
H7 LPAI for purposes of the regulations if:
     Antibodies to the H5 or H7 subtype of the AI virus that 
are not a consequence of vaccination have been detected in poultry, and
     Samples collected from the flock using real-time reverse 
transcription polymerase chain reaction (RT-PCR) or virus isolation are 
determined to be not infectious for H5/H7 LPAI.
    The definition would also provide that the official determination 
that H5/H7 LPAI virus exposure has occurred is by the identification of 
antibodies to the H5 or H7 subtype of AI virus detected and may only be 
made by APHIS' National Veterinary Services Laboratories (NVSL).

[[Page 66632]]

    We are proposing to define H5/H7 LPAI virus actively infected 
(infectious) in the following way. Poultry would be considered to be 
infected with H5/H7 LPAI for purposes of the regulations if:
     H5/H7 LPAI virus has been isolated and identified as such 
from poultry; or
     Viral antigen or viral RNA specific to the H5 or H7 
subtype of AI virus has been detected in poultry.
    The definition would also provide that the official determination 
that H5/H7 LPAI virus has been isolated and identified, or viral 
antigen or viral RNA specific to the H5 or H7 subtype of AI virus has 
been detected, may only be made by NVSL.
    We would also revise references to H5/H7 LPAI) infection (infected) 
and H5/H7 LPAI exposed throughout part 56 of the regulations to these 
two new terms instead.
    We believe the revised terms better clarify the distinction between 
exposed and infected poultry.
    We are also proposing to add definitions for cleaning, 
compensation, disinfection, indemnity, and virus elimination (VE) to 
Sec.  56.1 of the regulations.
    We would define cleaning as the removal of gross contamination, 
organic material, and debris from the premises or respective 
structures, via mechanical means like sweeping (dry cleaning) and/or 
the use of water and soap or detergent (wet cleaning), in order to 
minimize organic material to prepare for effective disinfection.
    We would define disinfection as methods used on surfaces to destroy 
or eliminate H5/H7 LPAI virus through physical (e.g., heat) or chemical 
(e.g., disinfectant) means, and would further specify that a 
combination of methods may be required.
    Section 56.3 of the regulations provides that APHIS may indemnify 
persons for cleaning and disinfection of premises, conveyances, and 
materials infected with or exposed to LPAI. While we believe it is 
clear from context that Sec.  56.3 pertains only to cleaning and 
disinfection associated with elimination of LPAI virus, rather than any 
cleaning and disinfection activities whatsoever that may be conducted 
on an affected premises, adding definitions of the terms to the 
regulations would further clarify our intent.
    For a similar reason, we are proposing to add the term virus 
elimination after every reference to cleaning and disinfection in part 
56 of the regulations. Virus elimination is the term used in many 
foreign countries for cleaning and disinfection measures conducted to 
destroy or eliminate all virus on an affected premises; we would define 
it in that way in Sec.  56.1. This would also underscore the 
restrictive sense in which cleaning and disinfection is being used 
within part 56.
    The term compensation would also be new to part 56. We would define 
compensation in Sec.  56.1 as reimbursement for the activities 
associated with the depopulation of infected or exposed poultry, 
including the disposal of contaminated carcasses and materials and the 
cleaning and disinfection of premises, conveyances, and materials that 
came into contact with infected or exposed poultry. The definition 
would further provide that, in the case of contaminated materials, if 
the cost of cleaning and disinfection would exceed the value of the 
materials, or cleaning and disinfection would be impracticable for any 
reason, APHIS would base compensation on the fair market value 
(depreciated value) of those materials. Finally, the definition would 
specify that compensation does not include payment for depopulated 
birds or eggs destroyed, as those payments would constitute indemnity.
    We would define indemnity as payments representing the fair market 
value of destroyed birds and eggs. Indemnity would not include 
reimbursements for depopulation (by which we mean the act of 
depopulation, rather than the depopulated poultry), or for disposal, 
destroyed materials, or cleaning and disinfection (virus elimination) 
activities, as these would be covered under the definition of 
compensation.
    Currently, the regulations in part 56 refer only to indemnity, 
regardless of the activity for which APHIS is providing reimbursement. 
However, the procedures for the payment of indemnity for destroyed 
birds or eggs differ significantly from those for the payment of 
indemnity for cleaning and disinfection. As a result, APHIS' Veterinary 
Services (VS) program, in conjunction with State departments of 
agriculture, has developed a guidance document, VS Guidance document 
8601.2 that clarifies how the two processes differ.\1\ The guidance 
document makes the distinction between compensation and indemnity that 
we are proposing to codify in the regulations themselves. We would also 
amend part 56 throughout to change references to ``indemnity'' that 
pertain to reimbursement for activities, rather than the destroyed 
poultry or eggs themselves, to ``compensation.''
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    \1\ See http://poultryimprovement.org/documents/ISRCPGuidanceDocument.pdf.
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Payment of Indemnity

    The regulations in Sec.  56.3 describe conditions for the payment 
of indemnity for H5/H7 LPAI. Paragraph (a) of the section lists 
activities that may be eligible for indemnity for H5/H7 LPAI: The 
destruction and disposal of infected poultry, the destruction of any 
eggs during outbreak testing, and disinfection of areas and materials 
that have come in contact with infected poultry. Paragraph (b) 
describes the percentage of costs that are eligible for indemnity for 
the listed activities, depending on certain criteria.
    Currently, paragraph (b) provides that, if poultry meet the 
definition of commercial, but does not participate in their respective 
NPIP Avian Influenza program, the maximum amount of indemnity that may 
be paid for eligible activities is 25 percent. Commercial poultry that 
do participate in Plan AI programs, however, may receive up to 100 
percent indemnity.
    This paragraph currently does not reflect the fact that the NPIP 
regulations themselves specifically exempt poultry operations that fall 
below certain size thresholds from having to participate in the NPIP AI 
programs. The exemption numbers are currently listed in 9 CFR part 146. 
We are proposing to amend paragraph (b) to clarify that poultry 
operations that are exempted by the Plan regulations from having to 
participate in Plan AI programs because of their size may still receive 
up to 100 percent indemnity and/or compensation for eligible 
activities.

Determination of Indemnity

    The current regulations in Sec.  56.4 describe how APHIS determines 
fair market value regarding the destruction of infected or exposed 
poultry; this includes determining indemnity for cleaning and 
disinfection procedures. The regulations currently state that APHIS 
will use an appraisal by an APHIS official appraiser and State official 
appraiser, or, in instances when APHIS and State authorities agree, 
either the APHIS appraiser or State appraiser alone, to determine fair 
market value for indemnity for destroyed poultry and eggs. However, we 
have discontinued use of appraisers in favor of an indemnity calculator 
drawn from multiple data points in order to determine fair market value 
for destroyed birds and eggs. We are therefore proposing to amend Sec.  
56.4 to indicate that appraisal calculator values will be used to 
determine the amount of indemnity paid for destroyed birds and eggs.

[[Page 66633]]

    Section 56.4 also describes how reimbursement may be paid for 
disposal activities. Currently, as a precondition for submitting a 
claim, the claimant, Cooperating State Agency, and APHIS must jointly 
enter into a cooperative agreement. However, State Agencies have stated 
that their participation in the cooperative agreement is not necessary. 
We are proposing to amend the regulations accordingly.
    Finally, Sec.  56.4 describes how indemnity may be paid for 
cleaning and disinfection activities. Currently, we require the 
claimant, the Cooperating State Agency, and APHIS to enter into a 
compliance agreement. The claimant then submits receipts or other 
documentation regarding the activities, and APHIS evaluates them 
against the cleaning and disinfection procedures in Sec.  56.5 of the 
regulations and the initial State response and containment plan, the 
requirements for which are found in Sec.  56.10 of the regulations.
    To streamline reimbursement for cleaning and disinfection 
activities, we have developed a calculator for cleaning and 
disinfection as well, the APHIS flat-rate virus elimination (VE) 
calculator. The calculator provides a per-square-foot rate for premises 
with floor-raised birds and per-cubic-foot rate for premises with caged 
birds for cleaning and disinfection activities that we have previously 
determined to fall within the scope of the regulations as reimbursable 
activities.
    While the VE calculator covers the majority of production types and 
VE scenarios, it does not cover every possibility. In such instances, 
the existing procedures for claiming compensation for cleaning and 
disinfection would apply. The floor-raised rates would be used by APHIS 
as the baseline for compensation in such instances, and the claimant 
would be afforded the opportunity to demonstrate through receipts or 
other documentation the uniqueness of his or her situation.

NPIP Certifications for Poultry Moved for Controlled Marketing

    Section 56.5 provides that, at the discretion of APHIS and the 
Cooperating State Agency, poultry that has been infected with or 
exposed to H5/H7 LPAI may be moved for controlled marketing rather than 
depopulated. We are proposing to amend the section to indicate that 
poultry moved for controlled marketing maintain their current NPIP 
certifications. This amendment would help provide assurances to 
slaughtering facilities that receive such flocks.

Revisions to Part 145

Definitions

    Section 145.1 of the regulations provides general definitions of 
terms used within the NPIP regulations. We are proposing to add a 
definition for the term Newcastle disease, and to revise the existing 
definition for avian influenza. Both the new definition and the revised 
definition would be modeled on the definitions of these terms found in 
the World Organization for Animal Health's (OIE's) Terrestrial Animal 
Health Code, to which the United States is a signatory.\2\
---------------------------------------------------------------------------

    \2\ To view the Code, go to https://www.oie.int/standard-setting/terrestrial-code/access-online/.
---------------------------------------------------------------------------

Specific Provisions for Participating Dealers

    Section 145.7 of the regulations requires participating dealers to 
follow all applicable provisions in part 145. However, the section 
refers to dealers in ``poultry breeding stock, hatching eggs, or baby 
or started poultry'' while the definition of dealer in Sec.  145.1 
refers to dealers as individuals or businesses that deal in commerce 
with hatching eggs, newly-hatched poultry, and/or started poultry. We 
are proposing to revise Sec.  145.7 so that it refers to dealers using 
the same term as in the definition in Sec.  145.1. The revised section 
would also indicate that dealers must comply with the regulations in 
the relevant part of the NPIP regulations. It would also specify the 
NPIP Program Standards that are applicable to such dealers, as well as 
the provisions of the NPIP regulations that provide for approval of 
alternatives to those standards.

Testing

    The regulations in Sec. Sec.  145.14 and 146.13 discuss the 
official avian influenza (AI) antibody detection tests, the enzyme-
linked immunosorbent assay (ELISA) test and agar gel immunodiffusion 
(AGID) test, in regard to poultry testing requirements within the NPIP.
    We are proposing to require that, when ELISA test samples are 
positive for AI, an AGID test must be conducted within 48 hours. This 
is because the AGID test is used as a confirmatory test on presumptive 
positives using the ELISA test. Timely corroboratory testing is 
therefore necessary in order to determine the disease status of the 
tested flock. Additionally, the AGID test must comply with the relevant 
NPIP requirements and would specify the relevant NPIP Program 
Standards, as well as provide a citation to the provisions for approval 
of alternate standards.
    Additionally, these sections currently provide that agent detection 
tests for AI may be used to detect influenza A matrix gene or protein. 
We are proposing to amend these sections to provide that agent 
detection tests may be used to detect influenza A virus rather than 
specifically influenza A matrix gene or protein. The existing 
limitation imposes an unnecessary technical restriction on test design 
and precludes the use of lateral flow antigen immunoassays that target 
the influenza nucleoprotein and still reliably indicate the presence or 
absence of AI in a test sample.
    For reasons that we discuss below, we are also proposing to add 
provisions regarding official tests for Newcastle disease (ND) to these 
two sections. The regulations would say that the official ND tests are 
serological tests for antibody detection and molecular-based tests for 
antigen detection that are listed in the Program Standards document as 
determined by APHIS to reliably detect ND infection. The Program 
Standards document would indicate that the approved serological tests 
for ND are currently the ELISA and hemagglutination inhibition (HI) 
tests, and the approved molecular-based test for ND is PCR.

Proposed Newcastle Disease Clean Program

    The regulations in Sec.  145.43 provide disease-free, or Clean, 
classifications that may be applied to turkey breeding flocks, and eggs 
and poults from turkey breeding flocks, provided that they meet certain 
requirements demonstrating freedom from that disease. Similar 
classification systems exist in Sec.  145.45 for compartments within 
the turkey breeding-hatchery industry; Sec.  145.73 for egg-type 
chicken breeding flocks, as well as their eggs and chicks; Sec.  145.74 
for compartments within the egg-type chicken breeding-hatchery 
industry; Sec.  145.83 for meat-type chicken breeding flocks, as well 
as their eggs and chicks; and Sec.  145.84 for compartments within the 
meat-type chicken breeding-hatchery industry.
    We are proposing to amend each of these sections to establish an ND 
Clean program. The ND Clean program is intended to allow the turkey 
breeding-hatchery, egg-type chicken breeding-hatchery, and meat-type 
chicken breeding-hatchery industries, as well as compartments within 
those industries, to demonstrate freedom from ND based on vaccination 
and/or monitoring of each participating breeding flock. Lastly, in 
regards to this paragraph's

[[Page 66634]]

language, we note that the original voting resolution in Sec.  145.43 
stated ``vaccination and monitoring of each participating breeding 
flock;'' however, given that vaccination is optional, we have replaced 
``and'' with ``and/or'' to accurately reflect the intended 
requirements.
    For a flock to gain ND Clean status, the Official State Agency 
(OSA) would have to determine that the flock is a primary breeding 
flock that either (1) has been vaccinated for ND using USDA-licensed 
vaccines and response to vaccination is serologically monitored using 
an approved serological ND test when the birds are more than 4 months 
of age; or (2) is unvaccinated for ND, in which a minimum of 30 birds 
have tested negative to ND using an approved test when more than 4 
months of age. We would require serological testing for vaccinated 
flocks because it indicates the increased presence of antibodies in 
vaccinated birds.
    To retain ND Clean classification for a vaccinated flock, the 
vaccine would have to be a USDA-licensed vaccine administered during 
the early stages of development through rearing, and an inactivated 
vaccine as final vaccination prior to the onset of egg production; the 
flock would have to be have been monitored for antibody response using 
an approved serological test (again, currently the ELISA or HI test) 
and the results would have to be compatible with immunological response 
against ND vaccination; and testing would have to include a minimum of 
30 birds with a serologic monitoring program when the birds are more 
than 4 months of age and prior to the onset of production and not 
longer than every 90 days thereafter.
    To retain ND Clean classification for unvaccinated flocks, during 
each 90-day period, all primary spent fowl, up to a maximum of 30, 
would have to test negative to ND within 21 days prior to movement to 
slaughter; and either a minimum of 30 birds for flock would have to 
test negative using an approved ND test (either serological or 
molecular-based) at intervals of 90 days, or a sample of fewer than 30 
birds could be tested, provided that all pens are equally represented 
and a total of 30 birds is tested within each 90 day period.
    Finally, for an ND Clean program for flocks to exist within a 
State, ND would have to be a disease reportable to the responsible 
State authority by all licensed veterinarians within the State. To 
accomplish this, all laboratories (including private, State, and 
university laboratories) that perform diagnostic procedures on poultry 
would have to examine all submitted cases of unexplained respiratory 
disease, egg production drops, and mortality for ND. In Sec.  145.15 of 
the regulations, as a general NPIP requirement, we require diagnostic 
surveillance for LPAI within participating States. Part of this 
diagnostic surveillance must include LPAI being a reportable disease. 
This requirement for the ND Clean program is modeled on that existing 
requirement for LPAI surveillance.
    The requirements for ND Clean compartments would be similar to the 
existing requirements for AI Clean compartments, and we would 
accordingly revise sections of the regulations regarding the 
establishment and maintenance of AI Clean compartments so that they 
would also apply to the establishment and maintenance of ND Clean 
Compartments.

Removal of the Pullorum Typhoid Agglutination Test for S. Enteritidis 
Clean Classifications

    The regulations in Sec. Sec.  145.23(d), 145.73(d), and 145.83(d) 
contain requirements for S. Enteritidis Clean classifications in the 
multiplier egg-type chicken breeding industry, primary egg-type chicken 
breeding industry, and primary meat-type chicken breeding industry, 
respectively. We are proposing to remove testing using the pullorum-
typhoid (PT) agglutination test from the U.S. S. Enteritidis Clean 
classification requirements.
    The PT agglutination test was adopted as a test for S. enteritidis 
in the 1980s based on similarities between the two diseases, and on the 
presumption that it could be used for both diseases. However, the test 
has since proven to be unreliable in detecting the presence of S. 
enteritidis. It would, however, continue to be used for testing for PT, 
for which it is reliable.

Revisions to Testing Protocols for AI in the Multiplier Meat-Type 
Chicken Breeding Industry

    Section 145.33 contains, among other things, requirements for 
determining a participating multiplier meat-type chicken breeding flock 
is free of AI for purposes of a Clean classification. Paragraph (l)(1) 
of that section provides three different possible testing protocols for 
a flock to retain Clean status.
    While the first option states at least 15 birds must test negative 
at intervals of 90 days, and the third option requires a total of 15 
samples collected and tested within a 90 day period, the second option 
requires 30 birds to be tested within each 90 day testing period. Our 
intent has always been that a total of 15 birds must be tested in each 
of the three options to retain the AI Clean classification; the 
discrepancy in the second option is the result of a drafting error. We 
are proposing to revise the second option to correct this error.
    The section also currently requires serological tests for testing 
of multiplier spent fowl. This limitation is not warranted because 
molecular-based tests such as PCR are also reliable for such testing. 
We are proposing to revise the section so that any AI test approved in 
accordance with Sec.  145.14 may be used.

Proposed Revisions to NPIP Provisions for Hobbyist and Exhibition 
Waterfowl, Exhibition Poultry and Raised-for-Release Waterfowl Breeding 
Flocks and Products

    Subpart E of part 145, ``Special Provisions for Hobbyist and 
Exhibition Waterfowl, Exhibition Poultry, and Game Bird Breeding Flocks 
and Products'' (Sec. Sec.  145.51-145.54), contains Plan requirements 
specific to the hobbyist, exhibition, and game bird industries. We are 
proposing several changes to this subpart.
    First, we are proposing to remove all references to game birds from 
subpart E due to the addition of proposed subpart J to part 145. The 
game bird industry has grown rapidly and has become more complex since 
its inception, and the terminology, production methods, and end uses in 
the industry are now significantly different than those in other 
poultry industries. Currently, subpart E does not have specific 
requirements for any one group of birds covered by its provisions, and 
subpart J would add testing regimes, terminology, and programs 
specifically designed for the game bird industry.
    In addition to the removal of game bird references, we would revise 
all references to ``waterfowl'' within the subpart to instead refer to 
``raised-for-release waterfowl,'' and would remove the definition for 
waterfowl from Sec.  145.51 of the regulations, and add a definition 
for raised-for-release waterfowl in its place. We are proposing to 
define raised-for-release waterfowl as domesticated fowl that normally 
swim, such as ducks and geese, grown under confinement for the primary 
purpose of producing eggs, chicks, started, or mature birds for release 
on game preserves or in the wild.
    Waterfowl is currently defined in Sec.  145.51 as domesticated fowl 
that normally swim, such as ducks and geese, and it is only apparent 
from subsequent sections of subpart E that the subpart does not apply 
to meat-type waterfowl, which are instead covered by

[[Page 66635]]

the provisions of a separate subpart I. These revisions would help to 
further clarify the scope of subpart E.
    We are also proposing to add a definition for hobbyist poultry. We 
would define hobbyist poultry as domesticated fowl which are bred for 
the purposes of meat and/or egg production on a small scale as 
determined by the Official State Agency. This would also help clarify 
the scope of subpart E.
    Section 145.52 contains requirements that flocks of hobbyist and 
exhibition waterfowl, exhibition poultry, and game bird breeding 
flocks, and the eggs and baby poultry produced from them, must meet in 
order to participate in the Plan.
    We are proposing to amend the introductory text of the section to 
remove the term ``baby poultry'' and instead indicate that it applies 
to chicks, started, and mature poultry. This will provide more clarity 
regarding the applicability of the section and align it with the 
terminology used elsewhere in part 145 of the regulations. We are also 
proposing revisions to the introductory text that reflect the usage the 
term ``raised-for-release waterfowl'' throughout the subpart and the 
creation of a new subpart J for gamebirds.
    Paragraph (c) of Sec.  145.52 currently recommends that waterfowl 
and gallinaceous flocks in open-air facilities be kept separate. 
However, it is a best practice not to commingle waterfowl, which can 
act as asymptomatic vectors of disease, and gallinaceous flocks, 
regardless of whether they are kept in contained or open-air 
facilities. We are proposing to amend paragraph (c) accordingly.
    Finally, we are proposing to add a paragraph (f) to the section to 
indicate that all participating raised-for-release waterfowl flocks, 
whether breeders or non-breeders, will be considered to be enrolled 
under subpart E of part 145 of the regulations. While provisions for 
non-breeding raised-for-release flocks are contained in part 146 of the 
regulations, rather than part 145, the testing requirements are 
identical. This will afford Plan participants some discretion in 
revising the intended use of a particular flock without jeopardizing 
the flock's status.

Terminology and Classification; Flocks and Products

    Section 145.53 of the regulations provide Clean classifications 
that may be applied to participating hobbyist and exhibition waterfowl, 
exhibition poultry, and game bird breeding flocks, and the eggs and 
baby poultry produced from them, provided that they meet certain 
requirements demonstrating freedom from that disease. We are proposing 
several changes to this section. This section would also discuss that 
hatcheries should be kept in sanitary conditions according to their 
relevant subpart and would specify the applicable part of the NPIP 
Program Standards that pertains to such hatcheries.
    In paragraph (b)(5), we are proposing to remove the term 
``exhibition waterfowl'' and use the term ``exhibition poultry.''
    Additionally, paragraph (f) of Sec.  145.53 contains requirements 
for a Salmonella Monitored classification. The Salmonella program 
currently only contains Salmonella testing and interventions at the 
hatchery level, and calls for five environmental samples from a 
hatchery every 30 days performed at an authorized laboratory in order 
for breeders to claims their products are monitored for Salmonella. We 
are proposing to add requirements for representative sampling of 
pullets and breeder farms. Hatched chicks transferred to farms are 
still at risk of contracting Salmonella.

Special Provisions for Egg/Meat-Type Game Bird and Raised-for-Release 
Game Bird Breeding Flocks and Products

    As we mentioned above, we are proposing to establish a new subpart 
J for the game bird industry. We are amending Sec. Sec.  145.24, 
145.34, 145.44, 145.54, and 145.94 to align them with the rest of the 
section regarding testing. The separation of the game bird industry 
from hobby and exhibition poultry in subpart E is necessary because the 
current definitions and provisions do not match the production methods 
and end uses for the game bird industry.
    Subpart J would consist of four sections: Sec. Sec.  145.101 for 
definitions, 145.102 for participation, 145.103 for terminology and 
classification of flocks and products, and 145.104 for terminology and 
classification of States.
    The requirements in proposed subpart J are drawn from the existing 
requirements in subpart E; however, some of the definitions, terms, and 
provisions would be unique to subpart J, and reflect the unique nature 
of the game bird industry. Key differences between subpart E and 
subpart J include the following:
     In subpart J, we are proposing to allow breeders to also 
hatch and/or grow out birds and still meet the definition of breeder. 
This will have the effect of allowing premises with breeding and ``grow 
out'' birds to be covered under one NPIP number, and will account for a 
common production model in the game bird industry.
     We are proposing definitions for the terms dealer, grower, 
and hatchery. Subpart E relies on the general definition for dealer in 
Sec.  145.1 of the regulations, and does not contain definitions for 
growers or hatcheries. However, in order for NPIP to accurately 
register game bird operations, definitions of these three terms are 
warranted within subpart J.
     The terms chick, egg, mature bird, and started bird, and 
raised-for-release bird would be defined within subpart J. Definitions 
are warranted in order to characterize these products within the game 
bird industry.
     While subpart E requires hatching eggs produced by 
breeding flocks to be fumigated or otherwise sanitized, subpart J would 
provide a third option in addition to fumigation or sanitization, 
``nest cleaning.'' ``Nest clean'' eggs are produced within the game 
bird industry on wire or otherwise away from the litter.
     We are proposing to allow a breeder, hatchery, or grower 
to also be a dealer without being categorized as a dealer, provided 
that, when reselling products, the breeder, hatchery, or grower has 
purchased those products from an NPIP participant with equal or greater 
classifications or from a flock with equivalent or greater testing 
requirements under official supervision. This allowance would simplify 
the registration and recordkeeping process for Plan participants within 
the game bird industry.
     The Pullorum-Typhoid Clean classification requirements 
reflect the terminology and production methods in the game bird 
industry.

Proposed Amendments to Part 146

    Part 146, subpart E, contains definitions and requirements for Plan 
participants within the game bird, commercial waterfowl, and raised-
for-release waterfowl industries who produce meat- or egg-type flocks.
    We are proposing to update the terminology in subpart E to match 
the other subparts within part 146 by replacing the term ``commercial'' 
with ``egg/meat-type.''
    Additionally, we are proposing to eliminate all provisions related 
to ``grow-out'' production from part 146; such poultry would be 
included in subpart E and our proposed subpart J within part 145.

Proposed Amendments to Part 147

Official Delegates

    Section 147.45 provides requirements regarding delegation and voter

[[Page 66636]]

representation for the NPIP's Biennial Conferences. The text currently 
states that each cooperating State is entitled to one official delegate 
for each of the programs in parts 145 and 146.
    We are proposing to allow a single, participating delegate to 
represent multiple States. Companies often have operations in various 
States, and this change would help those companies save money by 
appointing a single individual to represent all of the States where the 
company has operations.

Approval of Conference Recommendations by the Department

    Section 147.48 discusses the incorporation of recommendations from 
the NPIP Biennial Conferences into the NPIP provisions. The regulations 
do not currently have an established timeframe for the publication of 
NPIP Biennial Conference proposed changes; therefore, we are proposing 
to establish that we would publish a proposed rule to amend the 
regulations in the Federal Register within 14 months of the Biennial 
Conference. This will help ensure that, when a Biennial Conference is 
reviewing recommendations for amendments to the regulations, the 
regulations are up-to-date at the time of the Conference.

Authorized Laboratories

    In Sec.  147.52, the regulations state the minimum requirements for 
an APHIS authorized laboratory evaluation to ensure that they are in 
compliance with NPIP regulations. Within Sec.  147.52, paragraph (b) 
contains requirements to be a trained laboratory technician. Currently, 
testing procedures may only be overseen by technicians who successfully 
complete Service-approved laboratory workshops for Plan-specific 
diseases within the past 4 years.
    We are proposing to amend Sec.  147.52(b) by removing the word 
``within'' and replacing it with the word ``every.'' Technicians should 
attend a workshop for an individual Plan at 4-year intervals versus any 
time during a 4-year span. We are also proposing a minor editorial 
change to the paragraph which will indicate that ``all authorized 
laboratories'' must be overseen by a technician who meets the 
aforementioned criteria.

Executive Orders 12866 and 13771 and Regulatory Flexibility Act

    This proposed rule has been determined to be not significant for 
the purposes of Executive Order 12866 and, therefore, has not been 
reviewed by the Office of Management and Budget. Further, because this 
rule is not significant, it is not a regulatory action under Executive 
Order 13771.
    In accordance with the Regulatory Flexibility Act, we have analyzed 
the potential economic effects of this action on small entities. The 
analysis is summarized below. Copies of the full analysis are available 
by contacting the person listed under FOR FURTHER INFORMATION CONTACT 
or on the Regulations.gov website (see ADDRESSES above for instructions 
for accessing Regulations.gov).
    This rulemaking would result in various changes to regulations in 9 
CFR parts 56 and 145 through 147, modifying provisions of the NPIP. The 
modifications are recommended by the NPIP General Conference Committee 
(GCC), which represents cooperating State agencies and poultry industry 
members and advises the Secretary on issues pertaining to poultry 
health. The proposed rule would, among other changes, remove the 
Pullorum-Typhoid agglutination test as a test under which a flock can 
achieve Salmonella enteritidis clean classification, due to its 
unreliability; propose a Newcastle Disease Clean Program; specify that 
ELISA-positive samples for Avian Influenza (AI) must be sent for 
corroboratory testing within 48 hours; and broaden the criteria under 
which AI detection tests can be approved, while still requiring that 
the tests reliably detect AI virus. In addition, the proposed rule 
would clarify the testing period for AI tests to maintain AI Clean 
classification by correcting an editorial error; clarify that flocks 
that have been designated exposed to HPAI are not considered 
infectious; clarify when indemnity may be paid to breeders within the 
NPIP program; clarify the types of poultry in commerce; and clarify 
that NPIP dealers must follow the Program Standards in addition to the 
regulations. The proposal would create NPIP provisions specific to the 
game bird breeders industry and would set forth Salmonella testing for 
breeders, in addition to hatchers, relative to Salmonella Monitored 
status.
    These changes would align the regulations with international 
standards and make them more transparent to APHIS stakeholders and the 
general public. The changes included in this rule were voted on and 
approved by the voting delegates at the Plan's 2018 Biennial 
Conference.
    The establishments that would be affected by the rule--principally 
entities engaged in poultry production and processing--are 
predominantly small by Small Business Administration standards. In 
those instances in which an addition or modification could potentially 
result in a cost to certain entities, we do not expect the costs to be 
significant. This rule embodies changes decided upon by the NPIP GCC on 
behalf of Plan members, that is, changes recognized by the poultry 
industry as in their interest. We note that NPIP membership is 
voluntary. Under these circumstances, the Administrator of the Animal 
and Plant Health Inspection Service has determined that this action, if 
promulgated, will not have a significant economic impact on a 
substantial number of small entities.

Executive Order 12372

    This program/activity is listed in the Catalog of Federal Domestic 
Assistance under No. 10.025 and is subject to Executive Order 12372, 
which requires intergovernmental consultation with State and local 
officials. (See 2 CFR chapter IV.)

Executive Order 12988

    This proposed rule has been reviewed under Executive Order 12988, 
Civil Justice Reform. If this proposed rule is adopted: (1) All State 
and local laws and regulations that are in conflict with this rule will 
be preempted; (2) no retroactive effect will be given to this rule; and 
(3) administrative proceedings will not be required before parties may 
file suit in court challenging this rule.

Paperwork Reduction Act

    In accordance with Section 3507(d) of the Paperwork Reduction Act 
of 1995 (44 U.S.C. 3501 et seq.), the reporting, recordkeeping, and 
third-party disclosure requirements included in this proposed rule have 
been submitted for approval to the Office of Management and Budget 
(OMB). Please send comments on the Information Collection Request (ICR) 
to OMB's Office of Information and Regulatory Affairs via email to 
[email protected], Attention: Desk Officer for APHIS, 
Washington, DC 20503. Please state that your comments refer to Docket 
No. APHIS-2018-0062. Please send a copy of your comments to the USDA 
using one of the methods described under ADDRESSES at the beginning of 
this document.
    APHIS is proposing to amend the National Poultry Improvement 
Program regulations to establish a U.S. Newcastle Disease Clean program 
within NPIP. The Newcastle Disease Clean program is intended to allow 
the turkey breeding-hatchery, egg-type chicken breeding-hatchery, and 
meat-type chicken breeding-hatchery industries, as well as compartments 
within those industries, to demonstrate freedom from ND based

[[Page 66637]]

on vaccination and/or monitoring of each participating breeding flock. 
APHIS intends to determine the presence of Newcastle disease virus 
through vaccination and monitoring of each participating breeding 
flock. Implementing this rule will require information collection 
activities such as a revised flock selecting and testing reports; 
applications for U.S. Avian Flu and Newcastle Disease clean 
compartment, clean compartment component registrations, and compartment 
component removal; component audits; compliance statements; compliance 
agreements; description of business processes; biosecurity plans; 
appraisal and indemnity claims; response and containment plans; and 
recordkeeping.
    We are soliciting comments from the public (as well as affected 
agencies) concerning our proposed information collection requirements. 
These comments will help us:
    (1) Evaluate whether the proposed information collection is 
necessary for the proper performance of our agency's functions, 
including whether the information will have practical utility;
    (2) Evaluate the accuracy of our estimate of the burden of the 
proposed information collection, including the validity of the 
methodology and assumptions used;
    (3) Enhance the quality, utility, and clarity of the information to 
be collected; and
    (4) Minimize the burden of the information collection on those who 
are to respond (such as through the use of appropriate automated, 
electronic, mechanical, or other technological collection techniques or 
other forms of information technology; e.g., permitting electronic 
submission of responses).
    Estimate of burden: Public burden for this collection of 
information is estimated to average 1.84 hours per response.
    Respondents: Commercial poultry producers and State agricultural 
officials.
    Estimated annual number of respondents: 1,361.
    Estimated annual number of responses per respondent: 18.
    Estimated annual number of responses: 23,857.
    Estimated total annual burden on respondents: 43,810 hours. (Due to 
averaging, the total annual burden hours may not equal the product of 
the annual number of responses multiplied by the reporting burden per 
response.)
    A copy of the information collection may be viewed on the 
Regulations.gov website or in our reading room. (A link to 
Regulations.gov and information on the location and hours of the 
reading room are provided under the heading ADDRESSES at the beginning 
of this proposed rule.) Copies can also be obtained from Mr. Joseph 
Moxey, APHIS' Information Collection Coordinator, at (301) 851-2483. 
APHIS will respond to any ICR-related comments in the final rule. All 
comments will also become a matter of public record.

E-Government Act Compliance

    The Animal and Plant Health Inspection Service is committed to 
compliance with the E-Government Act to promote the use of the internet 
and other information technologies, to provide increased opportunities 
for citizen access to Government information and services, and for 
other purposes. For information pertinent to E-Government Act 
compliance related to this proposed rule, please contact Mr. Joseph 
Moxey, APHIS' Information Collection Coordinator, at (301) 851-2483.

List of Subjects

9 CFR Part 56

    Animal diseases, Indemnity payments, Low pathogenic avian 
influenza, Poultry.

9 CFR Parts 145, 146, and 147

    Animal diseases, Poultry and poultry products, Reporting and 
recordkeeping requirements.

    Accordingly, we propose to amend 9 CFR parts 56, 145, 146, and 147 
as follows:

PART 56--CONTROL OF H5/H7 LOW PATHOGENIC AVIAN INFLUENZA

0
1. The authority citation for part 56 continues to read as follows:

    Authority: 7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4.

0
2. Section 56.1 is amended as follows:
0
a. By adding, in alphabetical order, definitions for Cleaning, 
Compensation, and Disinfection;
0
b. By removing the definitions for H5/H7 LPAI exposed and H5/H7 LPAI 
infection (infected); and
0
c. By adding, in alphabetical order, definitions for H5/H7 LPAI virus 
actively infected (infectious), H5/H7 LPAI virus exposed (non-
infectious), Indemnity, and Virus elimination (VE).
    The additions read as follows:


Sec.  56.1  Definitions.

* * * * *
    Cleaning. The removal of gross contamination, organic material, and 
debris from the premises or respective structures, via mechanical means 
like sweeping (dry cleaning) and/or the use of water and soap or 
detergent (wet cleaning), in order to minimize organic material to 
prepare for effective disinfection.
* * * * *
    Compensation. In the case of H5/H7 LPAI detection, compensation 
specifically refers to reimbursement for the activities associated with 
the depopulation of infected or exposed poultry, including the disposal 
of contaminated carcasses and materials and the cleaning and 
disinfection of premises, conveyances, and materials that came into 
contact with infected or exposed poultry. In the case of contaminated 
materials, if the cost of cleaning and disinfection would exceed the 
value of the materials, or cleaning and disinfection would be 
impracticable for any reason, APHIS will base compensation on the fair 
market value (depreciated value) of those materials. Compensation does 
not include payment for depopulated birds or eggs destroyed (see 
definition of Indemnity in this section).
* * * * *
    Disinfection. Methods used on surfaces to destroy or eliminate H5/
H7 LPAI virus through physical (e.g., heat) or chemical (e.g., 
disinfectant) means. A combination of methods may be required.
* * * * *
    H5/H7 LPAI virus actively infected (infectious). (1) Poultry will 
be considered to be infected with H5/H7 LPAI for the purposes of this 
part if:
    (i) H5/H7 LPAI virus has been isolated and identified as such from 
poultry; or
    (ii) Viral antigen or viral RNA specific to the H5 or H7 subtype of 
AI virus has been detected in poultry.
    (2) The official determination that H5/H7 LPAI virus has been 
isolated and identified, or viral antigen or viral RNA specific to the 
H5 or H7 subtype of AI virus has been detected, may only be made by the 
National Veterinary Services Laboratories.
    H5/H7 LPAI virus exposed (non-infectious). (1) Poultry will be 
considered to be exposed (non-infectious) to H5/H7 LPAI for the 
purposes of this part if:
    (i) Antibodies to the H5 or H7 subtype of the AI virus that are not 
a consequence of vaccination have been detected in poultry; and
    (ii) Samples collected from the flock using real-time reverse 
transcription polymerase chain reaction (RT-PCR) or virus isolation are 
determined to be not infectious for H5/H7 LPAI.

[[Page 66638]]

    (2) The official determination that H5/H7 LPAI virus exposure has 
occurred is by the identification of antibodies to the H5 or H7 subtype 
of AI virus detected and may only be made by the National Veterinary 
Services Laboratories.
    Indemnity. Payments representing the fair market value of destroyed 
birds and eggs. Indemnity does not include reimbursements for 
depopulation, disposal, destroyed materials, or cleaning and 
disinfection (virus elimination) activities (see definition of 
Compensation in this section).
* * * * *
    Virus elimination (VE). Cleaning and disinfection measures 
conducted to destroy or eliminate all AI virus on an affected premises.
0
3. Section 56.3 is amended by revising the section heading and 
paragraphs (a) introductory text and (b) and (c) to read as follows:


Sec.  56.3  Payment of indemnity and/or compensation.

    (a) Activities eligible for indemnity and/or compensation. The 
Administrator may pay indemnity and/or compensation for the activities 
listed in this paragraph (a), as provided in paragraph (b) of this 
section:
* * * * *
    (b) Percentage of costs eligible for indemnity. Except for poultry 
that are described by the categories in this paragraph (b), the 
Administrator is authorized to pay 100 percent of the costs and/or 
compensation, as determined in accordance with Sec.  56.4, of the 
activities described in paragraphs (a)(1) through (3) of this section, 
regardless of whether the infected or exposed poultry participate in 
the Plan. For infected or exposed poultry that are described by the 
categories in this paragraph (b), the Administrator is authorized to 
pay 25 percent of the costs of the activities described in paragraphs 
(a)(1) through (3) of this section:
    (1)(i) The poultry are from a breeding flock, commercial flock, or 
slaughter plant that participates in any Plan program in part 145 or 
146 of this chapter but that does not participate in the U.S. Avian 
Influenza Clean, U.S. H5/H7 Avian Influenza Clean, or U.S. H5/H7 Avian 
Influenza Monitored program of the Plan available to the flock in part 
145 or 146 of this chapter; and
    (ii) The poultry are from:
    (A) A commercial table-egg laying premises with at least 75,000 
birds; or
    (B) A meat-type chicken slaughter plant that slaughters at least 
200,000 meat-type chickens in an operating week; or
    (C) A meat-type turkey slaughter plant that slaughters at least 2 
million meat-type turkeys in a 12 month period; or
    (D) A commercial waterfowl and commercial upland game bird 
slaughter plant that slaughters at least 50,000 birds annually; or
    (E) A raised-for-release upland game bird premises, raised-for-
release waterfowl premises, and commercial upland game bird or 
commercial waterfowl producing eggs for human consumption premises that 
raise at least 25,000 birds annually; or
    (F) A breeder flock premises with at least 5,000 birds.
    (2) The poultry are located in a State that does not participate in 
the diagnostic surveillance program for H5/H7 LPAI, as described in 
Sec.  146.14 of this chapter, or that does not have an initial State 
response and containment plan for H5/H7 LPAI that is approved by APHIS 
under Sec.  56.10, unless such poultry participate in the Plan with 
another State that does participate in the diagnostic surveillance 
program for H5/H7 LPAI, as described in Sec.  146.14 of this chapter, 
and has an initial State response and containment plan for H5/H7 LPAI 
that is approved by APHIS under Sec.  56.10.
    (c) Other sources of payment. If the recipient of indemnity and/or 
compensation for any of the activities listed in paragraphs (a)(1) 
through (3) of this section also receives payment for any of those 
activities from a State or from other sources, the indemnity and/or 
compensation provided under this part may be reduced by the total 
amount of payment received from the State or other sources to the 
extent that total payments do not exceed 100 percent of total 
reimbursable indemnity and/or compensation amounts.
0
4. Section 56.4 is revised to read as follows:


Sec.  56.4  Determination of indemnity and/or compensation amounts.

    (a) Destruction and disposal of poultry. (1) Indemnity for the 
destruction of poultry and/or eggs infected with or exposed to H5/H7 
LPAI will be based on the fair market value of the poultry and/or eggs, 
as determined by an appraisal. The appraisal will use the current APHIS 
appraisal calculator values; if no such calculator value exists, an 
APHIS official appraiser will provide an appraisal of fair market 
value. An indemnity request form must be signed by the owners and 
grower (if applicable) of the poultry and received by APHIS prior to 
the destruction of the poultry and eggs, unless the owners, grower, 
APHIS, and the Cooperating State Agency agree in writing that the 
poultry may be destroyed immediately. Reports of appraisals must show 
the number of birds and the value per head. Complete inventory records 
of all birds and/or eggs on the premises must be provided to APHIS 
prior to the start of depopulation.
    (2) Compensation for disposal of poultry and/or eggs infected with 
or exposed to H5/H7 LPAI will be based on receipts or other 
documentation maintained by the claimant verifying expenditures for 
disposal activities authorized by this part. Any disposal of poultry 
infected with or exposed to H5/H7 LPAI for which compensation is 
requested must be performed under a compliance agreement between the 
claimant and APHIS. APHIS will review claims for compensation for 
disposal to ensure that all expenditures relate directly to activities 
described in Sec.  56.5 and in the initial State response and 
containment plan described in Sec.  56.10. If disposal is performed by 
the Cooperating State Agency, APHIS will compensate the Cooperating 
State Agency for disposal under a cooperative agreement.
    (3) The destruction and disposal of the poultry and/or eggs must be 
conducted in accordance with the initial State response and containment 
plan for H5/H7 LPAI, as described in Sec.  56.10.
    (b) Cleaning and disinfection (virus elimination). (1) Compensation 
for cleaning and disinfection (virus elimination) of premises, 
conveyances, and materials that came into contact with poultry that are 
infected with or exposed to H5/H7 LPAI will be determined using the 
current APHIS flat-rate virus elimination (VE) calculator in effect at 
the time of the infection.
    (2) For premises types for which a flat-rate VE calculator is not 
available, reimbursement will be based on receipts or other 
documentation maintained by the claimant verifying expenditures for 
cleaning and disinfection (virus elimination) activities authorized by 
this part. Any cleaning and disinfection (virus elimination) of 
premises, conveyances, and materials for which compensation is 
requested must be performed under a compliance agreement between the 
claimant, the Cooperating State Agency, and APHIS. APHIS will review 
claims for compensation for cleaning and disinfection (virus 
elimination) to ensure that all expenditures relate directly to 
activities described in Sec.  56.5 and in the initial State response 
and containment plan described in Sec.  56.10.
    (i) In the case of materials, if the cost of cleaning and 
disinfection (virus

[[Page 66639]]

elimination) would exceed the value of the materials or cleaning and 
disinfection (virus elimination) would be impracticable for any reason, 
compensation for the destruction of the materials will be based on the 
fair market value (depreciated value) of those materials, as determined 
by an appraisal. Materials will be appraised by an APHIS official 
appraiser. Compensation for disposal of the materials will be based on 
receipts or other documentation maintained by the claimant verifying 
expenditures for disposal activities authorized by this part. 
Appraisals of materials must be reported on forms furnished by APHIS 
and must be signed by the appraisers and by the owners of the materials 
to indicate agreement with the appraisal amount. Appraisals of 
materials must be signed and received by APHIS prior to the disassembly 
or destruction of the materials, unless the owners, APHIS, and the 
Cooperating State Agency agree in writing that the materials may be 
disassembled and/or destroyed immediately. Any disposal of materials 
for which compensation is requested must be performed under a 
compliance agreement between the claimant, the Cooperating State 
Agency, and APHIS. APHIS will review claims for compensation for 
disposal to ensure that all expenditures relate directly to activities 
described in Sec.  56.5 and in the initial State response and 
containment plan described in Sec.  56.10.
    (ii) [Reserved]
    (c) Requirements for compliance agreements. The compliance 
agreement is a comprehensive document that describes the depopulation, 
disposal, and cleaning and disinfection (virus elimination) plans for 
poultry that were infected with or exposed to H5/H7 LPAI, or a premises 
that contained such poultry. The compliance agreement must set out cost 
estimates that include labor, materials, supplies, equipment, personal 
protective equipment, and any additional information deemed necessary 
by APHIS. A compliance agreement must indicate what tasks will be 
completed, who will be responsible for each task, and how much the work 
is expected to cost. Once work associated with the compliance agreement 
is completed, receipts and documentation detailing the activities 
specified in the agreement should be forwarded to APHIS for review, 
approval, and final payment. This documentation should be submitted to 
APHIS no later than 30 days after the quarantine release of the 
affected or exposed premises.

(Approved by the Office of Management and Budget under control 
number 0579-0007)

0
5. Section 56.5 is amended as follows:
0
a. By revising the section heading;
0
b. In paragraph (c)(1) introductory text, by adding the words ``and 
maintain their current National Poultry Improvement Plan (NPIP) 
certifications'' after the words ``controlled marketing''; and
0
c. By revising paragraphs (c)(2) and (d).
    The revisions read as follows:


Sec.  56.5  Destruction and disposal of poultry and cleaning and 
disinfection (virus elimination) of premises, conveyances, and 
materials.

* * * * *
    (c) * * *
    (2) Poultry moved for controlled marketing will not be eligible for 
indemnity under Sec.  56.3. However, any costs related to cleaning and 
disinfection (virus elimination) of premises, conveyances, and 
materials that came into contact with poultry that are moved for 
controlled marketing will be eligible for compensation under Sec.  
56.3.
    (d) Cleaning and disinfection (virus elimination) of premises, 
conveyances, and materials. Premises, conveyances, and materials that 
came into contact with poultry infected with or exposed to H5/H7 LPAI 
must be cleaned and disinfected; Provided, that materials for which the 
cost of cleaning and disinfection would exceed the value of the 
materials or for which cleaning and disinfection would be impracticable 
for any reason may be destroyed and disposed. Cleaning and disinfection 
must be performed in accordance with the initial State response and 
containment plan described in Sec.  56.10, which must be approved by 
APHIS. Cleaning and disinfection must also be performed in accordance 
with any applicable State and local environmental regulations.
0
6. Section 56.6 is amended as follows:
0
a. By revising the section heading;
0
b. In paragraph (a), by removing the word ``Compensation'' and adding 
the word ``Indemnity'' in its place;
0
c. By revising paragraph (b); and
0
d. In paragraph (c), by adding the words ``(virus elimination)'' after 
the word ``disinfection'' each time it appears.
    The revisions read as follows:


Sec.  56.6  Presentation of claims for indemnity and/or compensation.

* * * * *
    (b) Indemnity for the value of eggs to be destroyed due to 
infection or exposure to H5/H7 LPAI; and
* * * * *
0
7. Section 56.8 is amended as follows:
0
a. In paragraph (a) introductory text, by removing the word ``may'' and 
adding the word ``shall'' in its place; and
0
b. By revising paragraph (b).
    The revision reads as follows:


Sec.  56.8  Conditions for payment.

* * * * *
    (b)(1) If indemnity for the destroyed poultry or eggs is being 
provided for 100 percent of eligible costs under Sec.  56.3(b), the 
Administrator may pay contractors eligible for indemnity under this 
section 100 percent of the amount determined in paragraph (a) of this 
section.
    (2) If indemnity for the destroyed poultry or eggs is being 
provided for 25 percent of eligible costs under Sec.  56.3(b), the 
Administrator may pay contractors eligible for indemnity 25 percent of 
the amount determined in paragraph (a) of this section.
* * * * *


Sec.  56.9   [Amended]

0
8. Section 56.9 is amended as follows:
0
a. In paragraph (a), by removing the citation ``Sec.  56.4(a)(1)'' and 
adding the citation ``Sec.  56.4(a)'' in its place; and
0
b. In paragraph (b), by adding the words ``and/or compensation'' after 
the word ``indemnity'' both times it appears.


Sec.  56.10   [Amended]

0
9. In Sec.  56.10, paragraph (a) introductory text is amended by adding 
the words ``and/or compensation'' after the word ``indemnity''.

PART 145--NATIONAL POULTRY IMPROVEMENT PLAN FOR BREEDING POULTRY

0
10. The authority citation for part 145 continues to read as follows:

    Authority: 7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4.

0
11. Section 145.1 is amended as follows:
0
a. By revising the definition for Avian influenza;
0
b. By adding a definition for Newcastle disease in alphabetical order; 
and
0
c. By revising the definition for NPIP Program Standards.
    The revisions and addition read as follows:


Sec.  145.1  Definitions.

* * * * *
    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

[[Page 66640]]

pathogenicity index (IVPI) greater than 1.2 (or as an alternative at 
least 75 percent mortality).
* * * * *
    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 above 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 
Sec.  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.
* * * * *
0
12. Section 145.7 is revised to read as follows:


Sec.  145.7  Specific provisions for participating dealers.

    Dealers in hatching eggs, newly hatched poultry, or started poultry 
shall comply with the provisions in this part (within the NPIP Program 
Standards document, Program Standard C applies to hatcheries; 
alternatives to the program standards may also be approved by the 
Administrator under Sec.  147.53).
0
13. Section 145.14 is amended as follows:
0
a. By revising paragraphs (d)(1) and (2) introductory text; and
0
b. By adding paragraph (e).
    The revisions and addition read as follows:


Sec.  145.14  Testing.

* * * * *
    (d) * * *
    (1) Antibody detection tests--(i) 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 Sec.  147.53) 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.
* * * * *
    (e) For Newcastle Disease (ND). The official tests for ND are 
serological tests for antibody detection or molecular-based tests for 
antigen detection.
* * * * *


Sec.  145.23   [Amended]

0
14. Section 145.23 is amended as follows:
0
a. By removing paragraphs (d)(1)(vi) and (vii) and redesignating 
paragraphs (d)(1)(viii) and (ix) as paragraphs (d)(1)(vi) and (vii), 
respectively; and
0
b. By removing paragraph (d)(3) and redesignating paragraphs (d)(4) and 
(5) as paragraphs (d)(3) and (4), respectively.


Sec.  145.24   [Amended]

0
15. In Sec.  145.24, paragraph (a)(1)(i) is amended by removing ``Sec.  
145.23(b)(3)(i) through (vii), Sec.  145.33(b)(3)(i) through (vii), 
Sec.  145.43(b)(3)(i) through (vi), Sec.  145.53(b)(3)(i) through 
(vii), Sec.  145.73(b)(2)(i), Sec.  145.83(b)(2)(i), and Sec.  
145.93(b)(3)(i) through (vii)'' and adding ``Sec. Sec.  145.23(b)(3)(i) 
through (vii), 145.33(b)(3)(i) through (vii), 145.43(b)(3)(i) through 
(vi), 145.53(b)(3)(i) through (vii), 145.73(b)(2)(i), 145.83(b)(2)(i), 
145.93(b)(3)(i) through (vii), and 145.103(b)(3)(i) through (ix)'' in 
its place.
0
16. Section 145.33 is amended as follows:
0
a. In paragraph (l)(1)(ii), by removing the number ``30'' and adding 
the number ``15'' in its place; and
0
b. By revising paragraph (l)(2).
    The revision reads as follows:


Sec.  145.33  Terminology and classification; flocks and products.

* * * * *
    (l) * * *
    (2) During each 90-day period, all multiplier spent fowl, up to a 
maximum of 30, must be tested and found negative for avian influenza 
within 21 days prior to movement to slaughter.
* * * * *


Sec.  145.34   [Amended]

0
17. In Sec.  145.34, paragraph (a)(1)(i) is amended by removing ``Sec.  
145.23(b)(3)(i) through (vii), Sec.  145.33(b)(3)(i) through (vii), 
Sec.  145.43(b)(3)(i) through (vi), Sec.  145.53(b)(3)(i) through 
(vii), Sec.  145.73(b)(2)(i), Sec.  145.83(b)(2)(i), and Sec.  
145.93(b)(3)(i) through (vii)'' and adding ``Sec. Sec.  145.23(b)(3)(i) 
through (vii), 145.33(b)(3)(i) through (vii), 145.43(b)(3)(i) through 
(vi), 145.53(b)(3)(i) through (vii), 145.73(b)(2)(i), 145.83(b)(2)(i), 
145.93(b)(3)(i) through (vii), and 145.103 (b)(3)(i) through (ix)'' in 
its place.
0
18. Section 145.43 is amended by adding paragraph (h) to read as 
follows:


Sec.  145.43  Terminology and classification; flocks and products.

* * * * *
    (h) U.S. Newcastle Disease Clean. The program in this paragraph (h) 
is intended to be the basis from which the breeding-hatchery industry 
may conduct a program for the prevention and control of Newcastle 
disease. It is intended to determine the presence of Newcastle disease 
in primary breeding turkeys through vaccination and/or monitoring of 
each participating breeding flock. A flock and the hatching eggs and 
poults produced from it will qualify for the classification in this 
paragraph (h) when the Official State Agency determines that they have 
met the following requirements:
    (1) It is a primary breeding flock that is either:
    (i) Vaccinated for Newcastle disease using USDA-licensed vaccines 
and response to vaccination is serologically monitored using an 
approved test as

[[Page 66641]]

described in Sec.  145.14 when more than 4 months of age, and meets the 
criteria in paragraph (h)(2) of this section to retain classification; 
or
    (ii) Unvaccinated for Newcastle disease, in which a minimum of 30 
birds have tested negative to ND using an approved test as described in 
Sec.  145.14 when more than 4 months of age and meets the criteria in 
paragraph (h)(3) of this section to retain classification.
    (2) To retain the classification in this paragraph (h), for 
vaccinated flocks:
    (i) Vaccines for ND must be USDA-licensed vaccines administered 
during early stages of development through rearing, and inactivated 
vaccines as final vaccination prior to the onset of egg production; and
    (ii) The flock has been monitored for antibody response using 
approved serological tests as listed in Sec.  145.14 and the results 
are compatible with immunological response against ND vaccination; and
    (iii) Testing must include a minimum of 30 birds with a serologic 
monitoring program when more than 4 months of age and prior to the 
onset of production and not longer than every 90 days thereafter.
    (3) To retain the classification in this paragraph (h) for 
unvaccinated flocks:
    (i) A minimum of 30 birds per flock must test negative using an 
approved test in Sec.  145.14 at intervals of 90 days; or
    (ii) A sample of fewer than 30 birds may be tested, and found 
negative, at any one time if all pens are equally represented and a 
total of 30 birds is tested within each 90-day period; and
    (iii) During each 90-day period, all primary spent fowl, up to a 
maximum of 30, must test negative to ND within 21 days prior to 
movement to slaughter.
    (4) Newcastle disease must be a disease reportable to the 
responsible State authority (State veterinarian, etc.) by all licensed 
veterinarians. To accomplish this, all laboratories (private, State, 
and university laboratories) that perform diagnostic procedures on 
poultry must examine all submitted cases of unexplained respiratory 
disease, egg production drops, and mortality for ND.
* * * * *


Sec.  145.44   [Amended]

0
19. In Sec.  145.44, paragraph (a)(1)(i) is amended by removing ``Sec.  
145.23(b)(3)(i) through (vii), Sec.  145.33(b)(3)(i) through (vii), 
Sec.  145.43(b)(3)(i) through (vi), Sec.  145.53(b)(3)(i) through 
(vii), Sec.  145.73(b)(2)(i), Sec.  145.83(b)(2)(i), and Sec.  
145.93(b)(3)(i) through (vii)'' and adding ``Sec. Sec.  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), Sec.  
145.83(b)(2)(i), 145.93(b)(3)(i) through (vii), and 145.103(b)(3)(i) 
through (ix)'' in this place.
0
20. Section 145.45 is amended as follows:
0
a. By revising paragraph (a) introductory text;
0
b. In paragraph (a)(1) introductory text, by adding the words ``and 
ND'' after the word ``AI'' each time it appears;
0
c. In paragraph (a)(1)(i):
0
i. By adding the words ``and ND Clean in accordance with Sec.  
145.43(h)'' after the citation ``Sec.  145.43(g)'';
0
ii. By adding the words ``and ND'' after the words ``official tests for 
AI'' and adding the words ``and (e)'' after the citation ``Sec.  
145.14(d)''; and
0
iii. By removing the word ``AI-related'' and adding the words ``AI and 
ND-related'' in its place;
0
d. In paragraphs (a)(1)(iii) introductory text, (a)(1)(iii)(B) and (E), 
and (a)(1)(v), by adding the words ``and ND'' after the word ``AI'' 
each time it appears;
0
e. In paragraph (a)(1)(vi), by adding the words ``and ND'' after the 
word ``Influenza'';
0
f. In paragraph (a)(2)(iii):
0
i. By removing the words ``Clean classification'' and adding the words 
``and ND Clean classifications'' in their place;
0
ii. By adding the words ``and ND'' after the word ``AI'' both times it 
appears; and
0
iii. By removing the words ``avian influenza surveillance'' and adding 
the words ``avian influenza and ND surveillance'' in their place;
0
g. In paragraph (a)(3)(iii), by adding the words ``and ND'' after the 
word ``Influenza'';
0
h. In paragraph (a)(3)(iv), by adding the words ``and ND Clean program 
as described in Sec.  145.43(h)'' after the citation ``Sec.  
145.43(g)''; and
0
i. In paragraph (a)(3)(vii), by adding the words ``and (h)'' after the 
citation ``145.43(g)''.
    The revision reads as follows:


Sec.  145.45  Terminology and classification; compartments.

    (a) US H5/H7 AI and ND Clean Compartment. The program in this 
section is intended to be the basis from which the primary turkey 
breeding-hatchery industry may demonstrate the existence and 
implementation of a program that has been approved by the Official 
State Agency and APHIS to establish a compartment consisting of a 
primary breeding-hatchery company that is free of H5/H7 avian influenza 
(AI) and ND. This compartment has the purpose of protecting the defined 
subpopulation and avoiding the introduction and spread of H5/H7 AI and 
ND within that subpopulation 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:
* * * * *
0
21. The heading for subpart E, consisting of Sec. Sec.  145.51 through 
146.54, is revised to read as follows:

Subpart E--Special Provisions for Hobbyist and Exhibition Poultry, 
and Raised-for-Release Waterfowl Breeding Flocks and Products

0
22. Section 145.51 is amended as follows:
0
a. By removing the definition for Game birds;
0
b. By adding, in alphabetical order, definitions for Hobbyist poultry 
and Raised-for-release waterfowl; and
0
c. By removing the definition for Waterfowl.
    The additions read as follows:


Sec.  145.51  Definitions.

* * * * *
    Hobbyist poultry. Domesticated fowl which are bred for the purposes 
of meat and/or egg production on a small scale as determined by the 
Official State Agency.
    Raised-for-release waterfowl. Domesticated fowl that normally swim, 
such as ducks and geese, grown under confinement for the primary 
purpose of producing eggs, chicks, started, or mature birds for release 
on game preserves or in the wild.
0
23. Section 145.52 is amended as follows:
0
a. By revising the introductory text;
0
b. In paragraph (c), by removing the words ``in open air facilities''; 
and
0
c. By adding paragraph (f).
    The revision and addition read as follows:


Sec.  145.52  Participation.

    Participating flocks of hobbyist and exhibition poultry, raised-
for-release waterfowl, and the eggs, chicks, started, and mature 
poultry produced from them shall comply with the applicable general 
provisions of subpart A of this part and the special provisions of this 
subpart. The special provisions that apply to meat-type waterfowl 
flocks are found in subpart I of this part. The special provisions that 
apply to game

[[Page 66642]]

bird flocks are found in subpart J of this part.
* * * * *
    (f) All participating raised-for-release waterfowl flocks, 
regardless of whether they are breeders or non-breeders, shall be 
enrolled under this subpart.
0
24. Section 145.53 is amended as follows:
0
a. In paragraph (b)(5), by removing the words ``exhibition waterfowl 
or''; and
0
b. By revising paragraph (f).
    The revision reads as follows:


Sec.  145.53  Terminology and classification; flocks and products.

* * * * *
    (f) U.S. Salmonella Monitored. The program in this paragraph (f) is 
intended to be the basis from which the breeding-hatching industry may 
conduct a program for the prevention and control of salmonellosis. It 
is intended to reduce the incidence of Salmonella organisms in hatching 
eggs and day-old poultry through an effective and practical sanitation 
and testing program at the breeder farm and in the hatchery. This will 
afford other segments of the poultry industry an opportunity to reduce 
the incidence of Salmonella in their products. The following 
requirements must be met for a flock or hatchery to be eligible for the 
classification in this paragraph (f) as determined by the Official 
State Agency:
    (1) Hatcheries must be kept in a sanitary condition as applicable 
and as outlined in Sec.  145.6 (within the NPIP Program Standards 
document, Program Standard C applies to hatcheries; alternatives to the 
program standards may also be approved by the Administrator under Sec.  
147.53).
    (2) An Authorized Agent shall collect and submit to an authorized 
laboratory:
    (i) A minimum of five samples from the hatchery at least every 30 
days while in operation. These samples may include: Hatchery debris, 
swabs from hatchers, setters, hatchery environment, hatchery equipment, 
sexing tables and belts, meconium, chick box papers, hatching trays, or 
chick transfer devices. Samples will be examined bacteriologically at 
an authorized laboratory for Salmonella; and
    (ii) Annual environmental samples from each pullet and breeder farm 
in accordance with this section (within the NPIP Program Standards 
document, Program Standard B applies to bacteriological examination 
procedures; alternatives to the program standards may also be approved 
by the Administrator under Sec.  147.53). Samples will be examined 
bacteriologically at an authorized laboratory for Salmonella.
    (3) If Salmonella is identified through this testing:
    (i) A qualified poultry health professional knowledgeable with the 
operation will be consulted and will:
    (A) Review test results to evaluate the Salmonella monitoring 
program.
    (B) Use the Salmonella monitoring program test results to develop 
appropriate and practical Salmonella intervention measures.
    (ii) [Reserved]
    (4) To claim products are of the classification in this paragraph 
(f), all products shall be derived from a farm or hatchery that meets 
the requirements of the classification.
* * * * *


Sec.  145.54   [Amended]

0
25. In Sec.  145.54, paragraph (a)(1)(i) is amended by removing ``Sec.  
145.23(b)(3)(i) through (vii), Sec.  145.33(b)(3)(i) through (vii), 
Sec.  145.43(b)(3)(i) through (vi), Sec.  145.53(b)(3)(i) through 
(vii), Sec.  145.73(b)(2)(i), Sec.  145.83(b)(2)(i), and Sec.  
145.93(b)(3)(i) through (vii)'' and adding ``Sec. Sec.  145.23(b)(3)(i) 
through (vii), 145.33(b)(3)(i) through (vii), 145.43(b)(3)(i) through 
(vi), 145.53(b)(3)(i) through (vii), 145.73(b)(2)(i), 145.83(b)(2)(i), 
145.93(b)(3)(i) through (vii), and 145.103(b)(3)(i) through (ix)'' in 
its place.
0
26. Section 145.73 is amended as follows:
0
a. By removing paragraphs (d)(1)(vi) and (vii) and redesignating 
paragraphs (d)(1)(viii) and (ix) as paragraphs (d)(1)(vi) and (vii), 
respectively;
0
b. By removing paragraph (d)(3) and redesignating paragraphs (d)(4) and 
(5) as paragraphs (d)(3) and (4), respectively; and
0
c. By adding paragraph (h).
    The addition reads as follows:


Sec.  145.73  Terminology and classification; flocks and products.

* * * * *
    (h) U.S. Newcastle Disease Clean. The program in this paragraph (h) 
is intended to be the basis from which the breeding-hatchery industry 
may conduct a program for the prevention and control of Newcastle 
disease. It is intended to determine the presence of Newcastle disease 
in primary breeding chickens through vaccination and/or monitoring of 
each participating breeding flock. A flock and the hatching eggs and 
chicks produced from it will qualify for the classification in this 
paragraph (h) when the Official State Agency determines that they have 
met the following requirements:
    (1) It is a primary breeding flock that is either:
    (i) Vaccinated for Newcastle disease using USDA-licensed vaccines 
and response to vaccination is serologically monitored using an 
approved test as described in Sec.  145.14 when more than 4 months of 
age and meets the criteria in paragraph (h)(2) of this section to 
retain classification; or
    (ii) Unvaccinated for Newcastle disease, in which a minimum of 30 
birds have tested negative to ND using an approved test as described in 
Sec.  145.14 when more than 4 months of age and meets criteria in 
paragraph (h)(3) of this section to retain classification.
    (2) To retain the classification in this paragraph (h), for 
vaccinated flocks:
    (i) Vaccines for ND must be USDA-licensed vaccines administered 
during early stages of development through rearing, and inactivated 
vaccines as final vaccination prior to the onset of egg production; and
    (ii) The flock has been monitored for antibody response using 
approved serological tests as listed in Sec.  145.14 and the results 
are compatible with immunological response against ND vaccination; and
    (iii) Testing must include a minimum of 30 birds with a serologic 
monitoring program when more than 4 months of age and prior to the 
onset of production and not longer than every 90 days thereafter.
    (3) To retain the classification in this paragraph (h) for 
unvaccinated flocks:
    (i) A minimum of 30 birds per flock must test negative using an 
approved test as described in Sec.  145.14 at intervals of 90 days; or
    (ii) A sample of fewer than 30 birds may be tested, and found 
negative, at any one time if all pens are equally represented and a 
total of 30 birds is tested within each 90-day period; and
    (iii) During each 90-day period, all primary spent fowl, up to a 
maximum of 30, must test negative to ND within 21 days prior to 
movement to slaughter.
    (4) Newcastle disease must be a disease reportable to the 
responsible State authority (State veterinarian, etc.) by all licensed 
veterinarians. To accomplish this, all laboratories (private, State, 
and university laboratories) that perform diagnostic procedures on 
poultry must examine all submitted cases of unexplained respiratory 
disease, egg production drops, and mortality for ND.
0
27. Section 145.74 is amended as follows:
0
a. In paragraph (a) introductory text, by revising the paragraph 
heading, adding the words ``and Newcastle disease (ND)'' after the word 
``(AI)'', and

[[Page 66643]]

adding the words ``and ND'' after the word ``AI'';
0
b. In paragraph (a)(1) introductory text, by adding the words ``and 
ND'' after the word ``AI'' each time it appears;
0
c. In paragraph (a)(1)(i):
0
i. By adding the words ``and ND Clean in accordance with Sec.  
145.73(h)'' after the words ``in accordance with Sec.  145.73(f)'';
0
ii. By adding the words ``and ND'' after the words ``official tests for 
AI'' and adding the words ``and (e)'' after the citation ``Sec.  
145.14(d)''; and
0
iii. By removing the word ``AI-related'' and adding the words ``AI and 
ND-related'' in its place;
0
d. In paragraphs (a)(1)(iii), (a)(1)(iii)(B) and (E), and (a)(1)(v), by 
adding the words ``and ND'' after the word ``AI'' each time it appears;
0
e. In paragraph (a)(1)(vi), by adding the words ``and ND'' after the 
word ``Influenza'';
0
f. In paragraph (a)(2)(iii):
0
i. By removing the words ``Clean classification'' and adding the words 
``and ND Clean classifications'' in their place;
0
ii. By adding the words ``and ND'' after the word ``AI'' both times it 
appears; and
0
iii. By removing the words ``avian influenza surveillance'' and adding 
the words ``avian influenza and ND surveillance'' in their place;
0
g. In paragraph (a)(3)(iii), by adding the words ``and ND'' after the 
word ``Influenza'';
0
h. In paragraph (a)(3)(iv), by adding the words ``and ND Clean program 
as described in Sec.  145.73(h)'' after the citation ``Sec.  
145.73(f)'';
0
i. In paragraph (a)(3)(vii), by adding the words ``and (h)'' after the 
citation ``145.73(f); and
0
j. In paragraph (a)(4), by adding the words ``and/or ND'' after the 
word ``AI'' both times it appears.
    The revision reads as follows:


Sec.  145.74  Terminology and classification; compartments.

    (a) U.S. Avian Influenza and Newcastle Disease Clean Compartment. * 
* *
* * * * *
0
28. Section 145.83 is amended as follows:
0
a. By removing paragraph (e)(1)(iv) and redesignating paragraphs 
(e)(1)(v) and (vi) as paragraphs (e)(1)(iv) and (v), respectively; and
0
b. By adding paragraph (h).
    The addition reads as follows:


Sec.  145.83  Terminology and classification; flocks and products.

* * * * *
    (h) U.S. Newcastle Disease (ND) Clean. The program in this 
paragraph (h) is intended to be the basis from which the breeding-
hatchery industry may conduct a program for the prevention and control 
of Newcastle disease. It is intended to determine the presence of 
Newcastle disease in primary breeding chickens through vaccination and/
or monitoring of each participating breeding flock. A flock and the 
hatching eggs and chicks produced from it will qualify for the 
classification in this paragraph (h) when the Official State Agency 
determines that they have met the following requirements:
    (1) It is a primary breeding flock that is either:
    (i) Vaccinated for Newcastle disease using USDA-licensed vaccines 
and response to vaccination is serologically monitored using an 
approved test as described in Sec.  145.14 when more than 4 months of 
age and meets the criteria in paragraph (h)(2) of this section to 
retain classification; or
    (ii) Unvaccinated for Newcastle disease, in which a minimum of 30 
birds have tested negative to ND using an approved test as described in 
Sec.  145.14 when more than 4 months of age and meets criteria in 
paragraph (h)(3) of this section to retain classification.
    (2) To retain the classification in this paragraph (h), for 
vaccinated flocks:
    (i) Vaccines for ND must be USDA-licensed vaccines administered 
during early stages of development through rearing, and inactivated 
vaccines as final vaccination prior to the onset of egg production; and
    (ii) The flock has been monitored for antibody response using 
approved serological tests as described in Sec.  145.14 and the results 
are compatible with immunological response against ND vaccination; and
    (iii) Testing must include a minimum of 30 birds with a serologic 
monitoring program when more than 4 months of age and prior to the 
onset of production, and not longer than every 90 days thereafter.
    (3) To retain the classification in this paragraph (h) for 
unvaccinated flocks:
    (i) A minimum of 30 birds per flock must test negative using an 
approved test as described in Sec.  145.14 at intervals of 90 days; or
    (ii) A sample of fewer than 30 birds may be tested, and found 
negative, at any one time if all pens are equally represented and a 
total of 30 birds is tested within each 90-day period; and
    (iii) During each 90-day period, all primary spent fowl, up to a 
maximum of 30, must test negative to ND within 21 days prior to 
movement to slaughter.
    (4) Newcastle disease must be a disease reportable to the 
responsible State authority (State veterinarian, etc.) by all licensed 
veterinarians. To accomplish this, all laboratories (private, State, 
and university laboratories) that perform diagnostic procedures on 
poultry must examine all submitted cases of unexplained respiratory 
disease, egg production drops, and mortality for ND.
0
29. Section 145.84 is amended as follows:
0
a. In paragraph (a) introductory text, by revising the heading, adding 
the words ``and Newcastle disease (ND)'' after the words ``influenza 
(AI)'', and adding the words ``and ND'' after the words ``H5/H7 AI'';
0
b. In paragraph (a)(1) introductory text, by adding the words ``and 
ND'' after the word ``AI'' each time it appears;
0
c. By revising paragraph (a)(1)(i);
0
d. In paragraphs (a)(1)(iii) introductory text, (a)(1)(iii)(B) and (E), 
and (a)(1)(v), by adding the words ``and ND'' after the word ``AI'' 
each time it appears;
0
e. In paragraph (a)(1)(vi), by adding the words ``and ND'' after the 
word ``Influenza'';
0
f. In paragraph (a)(2)(iii):
0
i. Removing the words ``Clean classification'' and adding the words 
``and ND Clean classifications'' in their place;
0
ii. Adding the words ``and ND'' after the word ``AI'' both times it 
appears; and
0
iii. Removing the words ``avian influenza surveillance'' and adding the 
words ``avian influenza and ND surveillance'' in their place;
0
g. In paragraph (a)(3)(iv), by adding the words ``and ND Clean program 
as described in Sec.  145.83(h)'' after the citation ``Sec.  
145.83(g)''; and
0
h. In paragraph (a)(3)(vii), by adding the words '' and (h)'' after the 
citation ``145.83(g)''.
    The revisions read as follows:


Sec.  145.84  Terminology and classification; compartments.

    (a) U.S. Avian Influenza and Newcastle Disease Clean Compartment. * 
* *
    (1) * * *
    (i) Definition and description of the subpopulation of birds and 
their health status. All birds included in the compartment must be U.S. 
Avian Influenza Clean in accordance with Sec.  145.83(g) and ND Clean 
in accordance with Sec.  145.83(h). The poultry must also be located in 
a State that has an initial State response and containment plan 
approved by APHIS under Sec.  56.10 of

[[Page 66644]]

this chapter and that participates in the diagnostic surveillance 
program for H5/H7 low pathogenicity AI as described in Sec.  145.15. 
Within the compartment, all official tests for AI and ND, as described 
in Sec.  145.14(d) and (e), must be conducted in State or Federal 
laboratories or in NPIP authorized laboratories that meet the minimum 
standards described in Sec.  147.52 of this subchapter. In addition, 
the company must provide to the Service upon request any relevant 
historical and current H5/H7 AI and ND-related data for reference 
regarding surveillance for the disease and the health status of the 
compartment. Upon request, the Official State Agency may provide such 
data for other commercial poultry populations located in the State.
* * * * *


Sec.  145.94   [Amended]

0
30. In Sec.  145.94, paragraph (a)(1)(i) is amended by removing the 
word ``and'' and adding the words ``, and 145.103(b)(3)(i) through 
(ix)'' after the words ``145.93(b)(3)(i) through (vii)''.
0
31. Subpart J, consisting of Sec. Sec.  145.101 through 145.104, is 
added to read as follows:
Subpart J--Special Provisions for Egg/Meat-Type Game Bird and Raised-
for-Release Game Bird Breeding Flocks and Products
Sec.
145.101 Definitions.
145.102 Participation.
145.103 Terminology and classification; flocks and products.
145.104 Terminology and classification; States.

Subpart J--Special Provisions for Egg/Meat-Type Game Bird and 
Raised-for-Release Game Bird Breeding Flocks and Products


Sec.  145.101  Definitions.

    Except where the context otherwise requires, for the purposes of 
this subpart the following terms shall be construed, respectively, to 
mean:
    Egg/meat-type bird. Birds grown under confinement for the primary 
purpose of producing eggs and/or meat for human consumption.
    Game birds. Domesticated fowl such as pheasants, partridge, quail, 
grouse, and guineas, but not doves and pigeons.
    Raised-for-release bird. Birds grown under confinement for the 
primary purpose of producing eggs, chicks, started, or mature birds for 
release on game preserves or in the wild.


Sec.  145.102  Participation.

    Participating flocks of egg/meat-type game birds, raised-for-
release game birds, and the products produced from them shall comply 
with the applicable general provisions of subpart A of this part and 
the special provisions of this subpart. Participation is broken into 
the following categories of operation and products:
    (a) The categories for operation are:
    (1) Breeder. An individual or business that maintains a breeding 
flock for the purpose of producing eggs, chicks, started, or mature 
birds. A breeder that is also a hatchery and/or grower shall be 
categorized as a breeder.
    (2) Hatchery. A category of operations in which an individual or 
business does not have a breeding flock, but hatches eggs for the 
purpose of producing chicks, started, or mature birds. A hatchery that 
is also a grower shall be categorized as a hatchery.
    (3) Grower. A category of operations in which an individual or 
business does not have a breeding flock or hatchery, but raises birds 
for the purpose of selling started or mature birds.
    (4) Dealer. An individual or business that resells eggs, chicks, 
started, or mature birds. Products a dealer handles are typically 
resold within 30 days or less.
    (b) The categories for products are:
    (1) Egg. An egg laid by a female bird for the purpose of hatching a 
chick.
    (2) Chick. A bird that is newly hatched from an egg.
    (3) Started Bird. A bird that is between the age of a newly hatched 
chick and a mature bird.
    (4) Mature Bird. A bird that is fully colored and has reached the 
average maximum size specific to each species.
    (c) Products shall lose their identity under Plan terminology when 
not maintained by Plan participants under the conditions prescribed in 
Sec.  145.5(a).
    (d) Hatching eggs produced by breeding flocks shall be nest clean, 
fumigated, or otherwise sanitized in accordance with part 147 of this 
subchapter.
    (e) It is recommended that gallinaceous flocks and waterfowl flocks 
be kept separate.
    (f) Any nutritive material provided to baby poultry must be free of 
the avian pathogens that are officially represented in the Plan disease 
classifications listed in Sec.  145.10.
    (g) A flock of game birds that are not breeders, but are located on 
the same premise as game bird breeders, shall be covered under the same 
NPIP hatchery approval number as long as the appropriate testing 
requirements have been met.
    (h) All participating raised-for-release game bird flocks, 
regardless of whether they are breeders or non-breeders, shall be 
enrolled under this subpart.
    (i) A breeder, hatchery, or grower may also be a dealer without 
being categorized as a dealer. To resell products under the assigned 
NPIP number and avoid losing NPIP flock classifications, products must 
be purchased from an NPIP participant with equal or greater 
classifications or from a flock with equivalent or greater testing 
requirements under official supervision.
    (j) Subject to the approval of the Service and the Official State 
Agencies in the importing and exporting States, participating flocks 
may report poultry sales to importing States by using either VS Form 9-
3, ``Report of Sales of Hatching Eggs, Chicks, and Poults,'' or by 
using an invoice form (9-3I) approved by the Official State Agency and 
the Service to identify poultry sales to clients. If the 9-3I form is 
used, the following information must be included on the form:
    (1) The form number ``9-3I'', printed or stamped on the invoice;
    (2) The seller name and address;
    (3) The date of shipment;
    (4) The invoice number;
    (5) The purchaser name and address;
    (6) The quantity of products sold;
    (7) Identification of the products by bird variety or by NPIP stock 
code as listed in the NPIP APHIS 91-55-078 appendix; and
    (8) The appropriate NPIP illustrative design in Sec.  145.10. One 
of the designs in Sec.  145.10(b) or (g) must be used. The following 
information must be provided in or near the NPIP design:
    (i) The NPIP State number and NPIP approval number; and
    (ii) The NPIP classification for which product is qualified (e.g., 
U.S. Pullorum-Typhoid Clean).


Sec.  145.103  Terminology and classification; flocks and products.

    Participating flocks, and the eggs, chicks, started, and mature 
birds produced from them, which have met the respective requirements 
specified in this section may be designated by the following terms and 
the corresponding designs illustrated in Sec.  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 this paragraph (b). (See Sec.  145.14 relating to 
the official blood test where applicable.):
    (1) It has been officially blood tested with either no reactors or 
reactors that, upon further bacteriological examination conducted in 
accordance with part 147 of this subchapter, fail to isolate S. 
pullorum or S. gallinarum.

[[Page 66645]]

    (2) It is a started or mature bird flock that meets the following 
specifications as determined by the Official State Agency and the 
Service:
    (i) The flock is located in a State where all persons performing 
poultry disease diagnostic services within the State are required to 
report to the Official State Agency within 48 hours the source of all 
poultry specimens from which S. pullorum or S. gallinarum is isolated;
    (ii) The flock is composed entirely of birds that originated from 
U.S. Pullorum-Typhoid Clean breeding flocks or from flocks that met 
equivalent requirements under official supervision; and
    (iii) The flock is located on a premises where a flock not 
classified as U.S. Pullorum-Typhoid Clean was located the previous 
year; Provided, That an Authorized Testing Agent must blood test up to 
300 birds per flock, as described in Sec.  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 Sec.  145.14(a)(1), that were 
performed on an unclassified flock located on the premises during the 
previous year; the origins of the unclassified flock; and the 
probability of contacts between the flock for which qualification is 
being sought and infected wild birds, contaminated feed or waste, or 
birds, equipment, supplies, or personnel from flocks infected with 
pullorum-typhoid.
    (3) It is a breeding flock that originated from U.S. Pullorum-
Typhoid Clean breeding flocks or from flocks that met equivalent 
requirements under official supervision, and in which a sample of 300 
birds from flocks of more than 300, and each bird in flocks of 300 or 
less, has been officially tested for pullorum-typhoid: Provided, That a 
bacteriological examination monitoring program or serological 
examination monitoring program for game birds acceptable to the 
Official State Agency and approved by the Service may be used in lieu 
of annual blood testing: And provided further, That it is located in a 
State in which it has been determined by the Service that:
    (i) All hatcheries within the State are qualified as ``National 
Plan Hatcheries'' or have met equivalent requirements for pullorum-
typhoid control under official supervision;
    (ii) All hatchery supply flocks within the State, are qualified as 
U.S. Pullorum-Typhoid Clean or have met equivalent requirements for 
pullorum-typhoid control under official supervision: Provided, That if 
other domesticated fowl, except waterfowl, are maintained on the same 
premises as the participating flock, freedom from pullorum-typhoid 
infection shall be demonstrated by an official blood test of each of 
these fowl;
    (iii) All shipments of products other than U.S. Pullorum-Typhoid 
Clean, or equivalent, into the State are prohibited;
    (iv) All persons performing poultry disease diagnostic services 
within the State are required to report to the Official State Agency 
within 48 hours the source of all poultry specimens from which S. 
pullorum or S. gallinarum is isolated;
    (v) All reports of any disease outbreak involving a disease covered 
under the Plan are promptly followed by an investigation by the 
Official State Agency to determine the origin of the infection; 
Provided, That if the origin of the infection involves another State, 
or if there is exposure to poultry in another State from the infected 
flock, then the National Poultry Improvement Plan will conduct an 
investigation;
    (vi) All flocks found to be infected with pullorum or typhoid are 
quarantined until marketed or destroyed under the supervision of the 
Official State Agency, or until subsequently blood tested, following 
the procedure for reacting flocks as contained in Sec.  145.14(a)(5), 
and all birds fail to demonstrate pullorum or typhoid infection;
    (vii) All poultry, including exhibition, exotic, and game birds, 
but excluding waterfowl, going to public exhibition shall come from 
U.S. Pullorum-Typhoid Clean or equivalent flocks, or have had a 
negative pullorum-typhoid test within 90 days of going to public 
exhibition; and
    (viii) The flock is located in a State in which pullorum disease or 
fowl typhoid is not known to exist nor to have existed in hatchery 
supply flocks within the State during the preceding 24 months.
    (ix) Discontinuation of any of the conditions or procedures 
described in paragraphs (b)(3)(i) through (viii) of this section, or 
the occurrence of repeated outbreaks of pullorum or typhoid in poultry 
breeding flocks within or originating within the State shall be grounds 
for the Service to revoke its determination that such conditions and 
procedures have been met or complied with. Such action shall not be 
taken until a thorough investigation has been made by the Service and 
the Official State Agency has been given an opportunity to present its 
views.
    (c) U.S. H5/H7 Avian Influenza Clean. The program in this paragraph 
(c) is intended to be the basis from which the game bird industry may 
conduct a program for the prevention and control of the H5 and H7 
subtypes of avian influenza. It is intended to determine the presence 
of the H5 and H7 subtypes of avian influenza in game bird flocks 
through routine surveillance of each participating flock. A flock or 
premise, and the hatching eggs, chicks, started, and mature birds 
produced from it, will qualify for the classification in this paragraph 
(c) when the Official State Agency determines that it has met the 
following requirements:
    (1) It is a flock in which a minimum of 30 birds has been tested 
negative to the H5 and H7 subtypes of avian influenza as provided in 
Sec.  145.14(d) when more than 4 months of age. To retain the 
classification in this paragraph (c):
    (i) A sample of at least 30 birds must be tested negative at 
intervals of 90 days; or
    (ii) A sample of fewer than 30 birds may be tested, and found to be 
negative, at any one time if all pens are equally represented and a 
total of 30 birds are tested within each 90-day period.
    (2) For participants with non-breeding flocks retained for raised-
for-release or other purposes on the same premises as a breeding flock, 
a representative sample of at least 30 birds from the participating 
premise must be tested negative to the H5 and H7 subtypes of avian 
influenza as provided in Sec.  145.14(d) when more than 4 months of 
age, every 90 days.
    (d) U.S. Salmonella Monitored. The program in this paragraph (d) is 
intended to be the basis from which the game bird industry may conduct 
a program for the prevention and control of salmonellosis. It is 
intended to reduce the incidence of Salmonella organisms in day-old 
poultry through an effective and practical sanitation program in the 
hatchery. This will afford other segments of the poultry industry an 
opportunity to reduce the incidence of Salmonella in their products. 
The following requirements must be met for a flock to be of the 
classification in this paragraph (d):
    (1) An Authorized Agent shall collect a minimum of five 
environmental samples, e.g., chick papers, hatching trays, and chick 
transfer devices, from the hatchery at least every 30 days. Testing 
must be performed at an authorized laboratory.
    (2) To claim products are of the classification in this paragraph 
(d), all products shall be derived from a hatchery that meets the 
requirements of the classification.

[[Page 66646]]

    (3) The classification in this paragraph (d) may be revoked by the 
Official State Agency if the participant fails to follow recommended 
corrective measures.


Sec.  145.104  Terminology and classification; States.

    (a) U.S. Pullorum-Typhoid Clean State. (1) A State will be declared 
a U.S. Pullorum-Typhoid Clean State when it has been determined by the 
Service that:
    (i) The State is in compliance with the provisions contained in 
Sec. Sec.  145.23(b)(3)(i) through (vii), 145.33(b)(3)(i) through 
(vii), 145.43(b)(3)(i) through (vi), 145.53(b)(3)(i) through (vii), 
145.73(b)(2)(i), 145.83(b)(2)(i), 145.93(b)(3)(i) through (vii), and 
145.103(b)(3)(i) through (ix).
    (ii) No pullorum disease or fowl typhoid is known to exist nor to 
have existed in hatchery supply flocks within the State during the 
preceding 12 months: Provided, That pullorum disease or fowl typhoid 
found within the preceding 24 months in waterfowl, exhibition poultry, 
and game bird breeding flocks will not prevent a State, which is 
otherwise eligible, from qualifying.
    (2) Discontinuation of any of the conditions described in paragraph 
(a)(1)(i) of this section, or repeated outbreaks of pullorum or typhoid 
occur in hatchery supply flocks described in paragraph (a)(1)(ii) of 
this section, or if an infection spreads from the originating premises, 
the Service shall have grounds to revoke its determination that the 
State is entitled to the classification in this paragraph (a). Such 
action shall not be taken until a thorough investigation has been made 
by the Service and the Official State Agency has been given an 
opportunity for a hearing in accordance with rules of practice adopted 
by the Administrator.
    (b) [Reserved]

PART 146--NATIONAL POULTRY IMPROVEMENT PLAN FOR COMMERCIAL POULTRY

0
32. The authority citation for part 146 continues to read as follows:

    Authority: 7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4.

0
33. Section 146.13 is amended as follows:
0
a. By revising paragraph (b)(1); and
0
b. In paragraph (b)(2) introductory text, by removing the words 
``matrix gene or protein'' and adding the word ``virus'' in their 
place.
    The revision reads as follows:


Sec.  146.13  Testing.

* * * * *
    (b) * * *
    (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, 
Program Standard A applies to blood and yolk testing procedures; 
alternatives to the program standards may also be approved by the 
Administrator under Sec.  147.53) 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.
* * * * *
0
34. Section 146.51 is revised to read as follows:


Sec.  146.51  Definitions.

    Except where the context otherwise requires, for the purposes of 
this subpart the following terms shall be construed, respectively, to 
mean:
    Egg/meat-type game birds. Domesticated fowl such as pheasants, 
partridge, quail, grouse, and guineas, but not doves and pigeons grown 
under confinement for the primary purposes of producing eggs and/or 
meat for human consumption.
    Egg/meat-type waterfowl. Domesticated ducks or geese grown under 
confinement for the primary purposes of producing eggs and/or meat for 
human consumption.
    Meat-type game bird slaughter plant. A meat-type game bird 
slaughter plant that is federally inspected or under State inspection 
that the U.S. Department of Agriculture's Food Safety and Inspection 
Service has recognized as equivalent to Federal inspection.
    Meat-type waterfowl slaughter plant. A meat-type 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 recognized as equivalent to Federal inspection.
    Shift. The working period of a group of employees who are on duty 
at the same time.
0
35. Section 146.52 is revised to read as follows:


Sec.  146.52  Participation.

    (a) Participating meat-type game bird slaughter plants, meat-type 
waterfowl slaughter plants, and egg-type game bird and egg-type 
waterfowl premises producing eggs for human consumption shall comply 
with the applicable general provisions of subpart A of this part and 
the special provisions of this subpart.
    (b) Meat-type game bird slaughter plants and Meat-type waterfowl 
slaughter plants that slaughter fewer than 50,000 birds annually are 
exempt from the special provisions of this subpart.
    (c) Egg-type game bird and egg-type waterfowl premises with fewer 
than 25,000 birds are exempt from the special provisions of this 
subpart.
0
36. Section 146.53 is amended as follows:
0
a. In the introductory text, by adding the words ``slaughter plants 
and'' after the word ``participating'';
0
b. By revising paragraph (a) introductory text;
0
c. In paragraph (a)(1), by removing the words ``commercial upland'' and 
adding the word ``meat-type'' in their place and by removing the word 
``commercial'' and adding the word ``meat-type'' in its place;
0
d. By revising paragraph (a)(2);
0
e. In paragraph (a)(3), by removing the words ``commercial upland'' and 
adding the word ``meat-type'' in their place and by removing the word 
``commercial'' and adding the word ``meat-type'' in its place;
0
f. In paragraph (a)(4), by removing the words ``a commercial upland'' 
and adding the words ``an egg-type'' in their place and by adding the 
word ``egg-type'' after the words ``game bird or''.
0
g. In paragraph (a)(5), by removing the words ``a commercial upland'' 
and adding the words ``an egg-type'' in their place and by adding the 
word ``egg-type'' after the words ``game bird or''.
0
h. By removing and reserving paragraph (b).
    The revisions read as follows:


Sec.  146.53  Terminology and classification; slaughter plants and 
premises.

* * * * *
    (a) U.S. H5/H7 Avian Influenza Monitored. The program in this

[[Page 66647]]

paragraph (a) is intended to be the basis from which the egg/meat-type 
game bird and egg/meat-type waterfowl 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 egg/
meat-type game birds and egg/meat-type waterfowl through routine 
surveillance of each participating slaughter plant or, in the case of 
egg-producing flocks, the regular surveillance of these flocks. A 
slaughter plant or flock will qualify for the classification in this 
paragraph (a) when the Official State Agency determines that it has met 
one of the following requirements:
* * * * *
    (2) It is a meat-type game bird slaughter plant or meat-type 
waterfowl slaughter plant that only accepts egg/meat-type game birds or 
egg/meat-type waterfowl from flocks where a minimum of 11 birds per 
flock have been tested negative for the H5/H7 subtypes of avian 
influenza, as provided in Sec.  146.13(b), no more than 21 days prior 
to slaughter;
* * * * *

PART 147--AUXILIARY PROVISIONS ON NATIONAL POULTRY IMPROVEMENT PLAN

0
37. The authority citation for part 147 continues to read as follows:

    Authority:  7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4.

0
38. Section 147.45 is revised to read as follows:


Sec.  147.45  Official delegates.

    Each cooperating State shall be entitled to one official delegate 
for each of the programs prescribed in parts 145 and 146 of this 
subchapter 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 members and be certified by the 
Official State Agency. It is recommended but not required that the 
official delegates be Plan participants. Individuals may be allowed to 
be an official delegate or alternate delegate for up to three States in 
which that delegate has flocks or is a plan participant with 
acknowledgement and approval of the Official State Agencies. Each 
official delegate shall endeavor to obtain, prior to the Conference, 
the recommendations of industry members of their State with respect to 
each proposed change.
0
39. Section 147.48 is revised to read as follows:


Sec.  147.48  Approval of conference recommendations by the Department.

    Proposals adopted by the official delegates will be recommended to 
the Department for incorporation into the provisions of the National 
Poultry Improvement Plan (NPIP) in parts 56, 145, and 146 of this 
chapter and this subpart. The Department 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. The 
Department will publish the recommendations in the Federal Register 
within 14 months following the NPIP Biennial Conference.
0
40. In Sec.  147.52, paragraph (b) is revised to read as follows:


Sec.  147.52  Authorized laboratories.

* * * * *
    (b) Trained technicians. Testing procedures at all authorized 
laboratories must be run or overseen by a laboratory technician who 
every 4 years has attended, and satisfactorily completed, Service-
approved laboratory workshops for Plan-specific diseases.
* * * * *

    Done in Washington, DC, this 28th day of October 2019.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2019-23973 Filed 12-4-19; 8:45 am]
 BILLING CODE 3410-34-P