Accredited veterinarian. A veterinarian approved by the Administrator in accordance with part 161 of this chapter to perform functions specified in parts 1, 2, 3, and 11 of subchapter A of this chapter and subchapters B, C, and D of this chapter, and to perform functions required by cooperative State-Federal disease control and eradication programs.

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

Animal and Plant Health Inspection Service. The Animal and Plant Health Inspection Service of the United States Department of Agriculture (APHIS).

Animals. Livestock, poultry, and all other members of the animal kingdom, including birds whether domesticated or wild, but not including man.

APHIS employee. Any individual employed by the Animal and Plant Health Inspection Service who is authorized by the Administrator to do any work or perform any duty in connection with the control and eradication of disease.

Bird. Any member of the class aves other than poultry.

Buffer zone. The zone within a control area that immediately surrounds an infected zone.

Control area. The area around a premises infected with highly pathogenic avian influenza and consisting of an infected zone and a buffer zone, the bounds of which are determined and communicated to producers by Federal or State officials.

Department. The United States Department of Agriculture.

Disease. Foot-and-mouth disease, contagious pleuropneumonia, Newcastle disease, highly pathogenic avian influenza, infectious salmon anemia, spring viremia of carp, or any other communicable disease of livestock or poultry that in the opinion of the Secretary constitutes an emergency and threatens the livestock or poultry of the United States.

Infected zone. The zone within a control area that immediately surrounds a premises infected with highly pathogenic avian influenza, up to the beginning of the buffer zone.

Highly pathogenic avian influenza. (1) Any influenza virus that kills at least 75 percent of eight 4- to 6-week-old susceptible chickens within 10 days following intravenous inoculation with 0.2 ml of a 1:10 dilution of a bacteria-free, infectious allantoic fluid;

(2) Any H5 or H7 virus that does not meet the criteria in paragraph (1) of this definition, but has an amino acid sequence at the hemagglutinin cleavage site that is compatible with highly pathogenic avian influenza viruses; or

(3) Any influenza virus that is not an H5 or H7 subtype and that kills one to five chickens and grows in cell culture in the absence of trypsin.

Inspector in charge. An APHIS employee who is designated by the Administrator to take charge of work in connection with the control and eradication of disease.

ISA Program veterinarian. The APHIS veterinarian assigned to manage the infectious salmon anemia program for APHIS in the State of Maine and who reports to the Area Veterinarian in Charge.

Materials. Parts of barns or other structures, straw, hay, and other feed for animals, farm products or equipment, clothing, and articles stored in or adjacent to barns or other structures.

Mortgage. Any mortgage, lien, or other security or beneficial interest held by any person other than the one claiming indemnity.

Newcastle disease. Newcastle disease is an acute, rapidly spreading, and usually fatal viral infection of poultry caused by an avian paramyxovirus serotype 1 that meets one of the following criteria for virulence: The virus has an intracerebral pathogenicity index (ICPI) in day-old chicks (Gallus gallus) of 0.7 or greater; or 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. In this definition, amino acid residues are numbered from the N-terminus of the amino acid sequence deduced from the nucleotide sequence of the F0 gene; 113-116 corresponds to residues −4 to −1 from the cleavage site. Failure to demonstrate the characteristic pattern of amino acid residues as described above may require characterization of the isolated virus by an ICPI test. A failure to detect a cleavage site that is consistent with virulent strains does not confirm the absence of a virulent virus.

Person. Any individual, corporation, company, association, firm, partnership, society, joint stock company, or other legal entity.

Pet bird. Any bird that is kept for personal pleasure and is not for sale.

Poultry. Chickens, ducks, geese, swans, turkeys, pigeons, doves, pheasants, grouse, partridges, quail, guinea fowl, and pea fowl.

Poultry biosecurity plan. A document utilized by an owner and/or contractor describing the management practices and principles that are used to prevent the introduction and spread of infectious diseases of poultry at a specific facility.

Secretary. The Secretary of Agriculture of the United States, or any officer or employee of the Department to whom authority has been or may be delegated to act in the Secretary's stead.

State. Each of the States of the United States, the District of Columbia, Puerto Rico, the Northern Mariana Islands, Guam, the Virgin Islands of the United States, or any other territory or possession of the United States.

(a) The Administrator is hereby authorized to invite the proper State authorities to cooperate with the Department in the control and eradication of any disease within the meaning of § 53.1.

(b) Upon agreement of the authorities of the State to enforce quarantine restrictions and orders and directives properly issued in the control and eradication of such a disease, the Administrator is hereby authorized to agree, on the part of the Department, to cooperate with the State in the control and eradication of the disease, and to pay 50 percent (and in the case of Newcastle disease or highly pathogenic avian influenza, up to 100 percent, and in the case of infectious salmon anemia, up to 60 percent) of the expenses of purchase, destruction and disposition of animals, eggs, and materials required to be destroyed because of being contaminated by or exposed to such disease: Provided, however, that if the animals or eggs were exposed to such disease prior to or during interstate movement and the owners or parties contracting with the owners to raise or care for the animals or eggs are not eligible to receive indemnity from any State, the Department may pay up to 100 percent of the purchase, destruction, and disposition of animals, eggs, and materials required to be destroyed; Provided further, that the cooperative program for the purchase, destruction, and disposition of birds shall be limited to birds which are identified in documentation pursuant to Agreements between the Department and the particular State involved relating to cooperative animal (including poultry) disease prevention, control, and eradication, as constituting a threat to the poultry industry of the United States; And provided further, that the Secretary may authorize other arrangements for the payment of such expenses upon finding that an extraordinary emergency exists.

(a) Animals or eggs affected by or exposed to disease, and materials required to be destroyed because of being contaminated by or exposed to disease shall be appraised by an APHIS employee and a representative of the State jointly, or, if the State authorities approve, by an APHIS employee alone.

(b) The appraisal of animals shall be based on the fair market value and shall be determined by the meat, egg production, dairy or breeding value of such animals. Animals may be appraised in groups providing they are the same species and type and providing that where appraisal is by the head each animal in the group is the same value per head or where appraisal is by the pound each animal in the group is the same value per pound.

(c) Appraisals of animals shall be reported on forms furnished by APHIS. Reports of appraisals shall show the number of animals of each species and the value per head or the weight and value by pound.

(d) Appraisals of materials shall be reported on forms furnished by APHIS. Reports of appraisals of materials shall, when practicable, show the number, size or quantity, unit price, and total value of each kind of material appraised.

(e) Indemnity for eggs required to be destroyed due to an outbreak of highly pathogenic avian influenza will be based on the fair market value of the eggs, as determined by an appraisal. Appraisals of eggs shall be reported on forms furnished by APHIS. The amount of indemnity paid, together with the amount for net salvage the owner or contractor received, if any, shall not exceed the appraised fair market value of the eggs.

(a) Except as provided in paragraph (b) of this section, animals infected with or exposed to disease shall be killed promptly after appraisal and disposed of by burial or burning, unless otherwise specifically provided by the Administrator, at his or her discretion. In the case of animals depopulated due to spring viremia of carp or infectious salmon anemia, salvageable fish may be sold for rendering, processing, or any other purpose approved by the Administrator. The proceeds gained from the sale of the fish will be subtracted from any payment from APHIS for which the producer or owner is eligible under § 53.2(b) or § 53.11.

(b) Eggs infected with, exposed to, or contaminated by highly pathogenic avian influenza shall be disposed of pursuant to the regulations in this part under the supervision of an APHIS employee who shall prepare and transmit to the Administrator a report identifying all eggs disposed thereof.

(c) The killing of animals and the burial, burning, or other disposal of carcasses of animals pursuant to the regulations in this part shall be supervised by an APHIS employee who shall prepare and transmit to the Administrator a report identifying the animals and showing the disposition thereof.

(a) In order to prevent the spread of disease, materials contaminated by or exposed to disease shall be disinfected: Provided, however, That in all cases in which the cost of disinfection would exceed the value of the materials or disinfection would be impracticable for any reason, the materials shall be destroyed, after appraisal as provided in § 53.3.

(b) The disinfection or destruction of materials under this section shall be under the supervision of an APHIS employee who shall prepare and transmit to the Administrator a certificate identifying all materials which are destroyed, showing the disposition thereof.

Animals of species not susceptible to the disease for which a quarantine has been established, but which have been exposed to the disease, shall be disinfected when necessary by such methods as the Administrator shall prescribe from time to time.

All premises, including barns, corrals, stockyards and pens, and all cars, vessels, aircraft, and other conveyances, and the materials thereon, shall be cleaned and disinfected under supervision of an APHIS employee whenever necessary for the control and eradication of disease. Expenses incurred in connection with such cleaning and disinfection shall be shared according to the agreement reached under § 53.2 with the State in which the work is done. In the case of low pathogenic avian influenza related to the 2002 disease situations in Virginia and Texas associated with the H5 or H7 virus, premises may not be restocked with poultry until at least 7 days following such cleaning and disinfection, unless the Administrator determines that a shorter or longer period of time is adequate or necessary to protect new poultry against infection.

(a) Claims for the following must be presented to APHIS, through the inspector in charge, on a form approved by the Administrator:

(1) Compensation for the value of animals;

(2) The cost of burial, burning, or other disposition of animals;

(3) The value of material destroyed; and

(4) The expenses of destruction.

(b) [Reserved]

When animals, eggs, or materials have been destroyed pursuant to the requirements contained in this part, any claim for indemnity shall be presented on forms furnished by APHIS on which the owner of the animals, eggs, or materials shall certify that the animals, eggs, or materials covered thereby, are, or are not, subject to any mortgage as defined in this part. If the owner states there is a mortgage, forms furnished by APHIS shall be signed by the owner and by each person holding a mortgage on the animals, eggs, or materials, consenting to the payment of any indemnity allowed to the person specified thereon.

(a) The Department will not allow claims arising under the terms of this part if the payee has not complied with all quarantine requirements.

(b) Expenses for the care and feeding of animals held for destruction will not be paid by the Department, unless the payment of such expense is specifically authorized or approved by the Administrator.

(c) The Department will not allow claims arising out of the destruction of animals, eggs, or materials unless they shall have been appraised as prescribed in this part and the owners thereof shall have executed a written agreement to the appraisals.

(d) The Department will not allow claims arising out of the destruction of animals, eggs, or materials which have been moved or handled by the owner thereof or its officer, employee, or agent, acting within the scope of his or its office, employment or agency, in violation of a law or regulation administered by the Secretary for the prevention of the introduction into or the dissemination within the United States of any communicable disease of livestock or poultry for which the animal or material was destroyed, or in violation of a law or regulation for the enforcement of which the Secretary enters or has entered into a cooperative agreement for the control and eradication of such disease.

(e) The Department will not allow claims arising out of the destruction of fish due to infectious salmon anemia (ISA) unless the claimants have agreed in writing to participate fully in the cooperative ISA control program administered by APHIS and the State of Maine. Participants in the ISA control program must:

(1) Establish and maintain a veterinary client-patient relationship with an APHIS accredited veterinarian and inform the ISA Program Veterinarian in writing of the name of their accredited veterinarian at the time the participant enrolls in the ISA program and within 15 days of any change in accredited veterinarians.

(2) Cooperate with and assist in periodic on-site disease surveillance, testing, and reporting activities for ISA, which will be conducted by their APHIS accredited veterinarian or a State or Federal official as directed by the ISA Program Veterinarian.

(3) Develop and implement biosecurity protocols for use at all participant-leased finfish sites and participant-operated vessels engaged in aquaculture operations throughout Maine. A copy of these protocols shall be submitted to the ISA Program Veterinarian at the time the participant enrolls in the ISA program and within 15 days of any change in the protocols.

(4) Develop, with the involvement of the participant's accredited veterinarian and the fish site health manager, a site-specific ISA action plan for the control and management of ISA. A copy of the action plan shall be submitted to APHIS for review at the time the participant enrolls in the ISA program and within 15 days of any change in the action plan.

(5) Participate in the State of Maine's integrated pest management (IPM) program for the control of sea lice on salmonids. A copy of the management plan developed by the participant for the State IPM program shall be submitted to APHIS for review at the time the participant enrolls in the ISA program and within 15 days of any change in the management plan.

(6) Submit to the ISA Program Veterinarian at the time the participant enrolls in the ISA program a complete and current fish inventory information for each participant-leased finfish site with site and cage identifiers. Fish inventory information must include the numbers, age, date of saltwater transfer, vaccination status, and previous therapeutant history for all fish in each participant-leased finfish site.

(7) Maintain, and make available to the ISA Program Veterinarian upon request, mortality data for each participant-leased finfish site and pen in production.

(8) Cooperate with and assist APHIS in the completion of biosecurity audits at all participant-leased finfish sites and participant-operated vessels involved in salmonid aquaculture.

(f) The Department will not allow claims arising out of the destruction of fish due to spring viremia of carp (SVC) unless the claimants have done the following:

(1) Depopulated all SVC-infected and SVC-exposed fish on their property under the supervision of USDA or State officials;

(2) Thoroughly cleaned and disinfected all affected sites and all affected equipment under the supervision of USDA or State officials;

(3) If an affected site is to be restocked after cleaning and disinfection, the claimant must have done the following:

(i) Restocked with fish certified free of SVC by an APHIS-approved laboratory or in accordance with the diagnostic procedures described in the Office of International des Epizooties Manual of Diagnostic Tests For Aquatic Animals;

(ii) Demonstrated that their water sources are from first-use spring water, spring water without fish, well water, ozone or ultraviolet treated surface water, or bore-hole water and are free of wild carp and any other SVC-susceptible species; and

(iii) Prevented the migration of wild carp and any other wild SVC-susceptible species into their farming establishment.

(g)(1) Except as provided in paragraph (g)(2) of this section, the Department will not allow claims arising out of the destruction of poultry or eggs destroyed due to an outbreak of highly pathogenic avian influenza unless the following conditions apply:

(i) Approved biosecurity plan. The owner of the poultry or eggs and, if applicable, any party that enters into a contract with the owner to grow or care for the poultry or eggs, had in place, at the time of detection of highly pathogenic avian influenza, and was following a poultry biosecurity plan that meets the requirements of § 53.11(e).

(ii) Buffer zone movement audit. For indemnity claims for poultry moved onto a premises located in a buffer zone of a control area for highly pathogenic avian influenza, the premises receiving the poultry must pass a biosecurity audit conducted in accordance with § 53.11(f)(1)(i) prior to the movement of poultry onto the premises; unless the premises receiving the poultry passed a biosecurity audit within the preceding six (6) months. Provided, that the Administrator may, upon request by a producer and upon his or her determination that such action will not result in the dissemination of highly pathogenic avian influenza within the United States, allow a premises to pass a biosecurity audit in accordance with § 53.11(f)(1)(i) after the placement of poultry onto the premises. The producer must make such a request in writing and state in the request all the facts and reasons justifying the request. If the request is denied, the premises must pass a biosecurity audit in accordance with § 53.11(f)(1)(i) prior to the placement of poultry onto the premises to be eligible to receive future indemnity payment if the poultry is later infected with highly pathogenic avian influenza.

(iii) Previously infected premises audit. For indemnity claims for poultry moved onto any premises that was previously infected with highly pathogenic avian influenza during the same outbreak, the premises must pass a biosecurity audit conducted in accordance with § 53.11(f)(1)(ii) prior to the movement of poultry onto the premises; unless the movement occurs after the United States declares freedom from highly pathogenic avian influenza. In addition, all previously infected premises must pass virtually conducted biosecurity audits every six (6) months until the State in which the premises is located declares freedom from highly pathogenic avian influenza.

(2) Owners and contractors are exempted from the requirements of paragraph (g)(1) of this section if the facilities where the poultry or eggs are raised or cared for falls under one of the following categories:

(i) Commercial table-egg laying premises with fewer than 75,000 birds;

(ii) Egg-type game bird and egg-type waterfowl premises with fewer than 25,000 birds.

(iii) Premises on which fewer than 100,000 broilers are raised annually; and

(iv) Premises on which fewer than 30,000 meat turkeys are raised annually.

(3) Notwithstanding the conditions in paragraphs (g)(1) and (2) of this section, the Department will not pay claims arising out of the destruction of poultry destroyed due to an outbreak of highly pathogenic avian influenza if the poultry was moved onto a premises in an infected zone and if the poultry becomes infected with HPAI within 14 days following the dissolution of the control area in which the infected zone is located.

(a) When poultry or eggs have been destroyed pursuant to this part, the Administrator may pay claims to any party with whom the owner of the poultry or eggs has entered into a contract for the growing or care of the poultry or eggs. The indemnity the Administrator may pay to such a party or parties shall be determined as by the following method:

(1) Divide the value in dollars of the contract the owner entered into with the contractor by the duration in days of the contract as it was signed prior to the highly pathogenic avian influenza outbreak;

(2) Multiply this figure by the time in days between the date the contractor began to provide services relating to the destroyed poultry or eggs under the contract and the date the poultry or eggs were destroyed due to highly pathogenic avian influenza.

(b) If a contractor receiving indemnity under this section has received any payment under his or her contract from the owner of the poultry or eggs at the time the poultry or eggs are destroyed, the amount of indemnity for which the contractor is eligible will be reduced by the amount of the payment the contractor has already received.

(c) If indemnity is paid to a contractor under this section, the owner of the poultry or eggs will be eligible to receive the difference between the indemnity paid to the contractors and the total amount of indemnity that may be paid for the poultry or eggs.

(d) In the event that determination of indemnity due a contractor using the method described in paragraph (a) of this section is determined to be impractical or inappropriate, APHIS may use any other method that the Administrator deems appropriate to make that determination.

(e)(1) The owner and, if applicable, the contractor, unless exempted under § 53.10(g)(2), must have a poultry biosecurity plan that is approved by the Administrator. Approved biosecurity principles are listed in the NPIP Program Standards, as defined in § 147.51 of this chapter. Alternative biosecurity principles may also be approved by the Administrator in accordance with § 147.53(d)(2) of this chapter.

(2)(i) The biosecurity plan shall be audited at least once every 2 years or a sufficient number of times during that period to satisfy the owner and/or contractor's Official State Agency that the plan is in compliance with the biosecurity principles contained in the NPIP Program Standards. The audit will include, but may not be limited to, a review of the biosecurity plan, as well as documentation that it is being implemented.

(ii) To be recognized as being in compliance with the biosecurity principles and eligible for indemnity, owners and contractors who fail the initial audit conducted by the NPIP Official State Agency must have a check audit performed by a team appointed by National NPIP Office and must demonstrate that they have implemented applicable biosecurity measures. The team will consist of an APHIS poultry subject matter expert, the Official State Agency, and a licensed, accredited, industry poultry veterinarian.

(f)(1) The Department requires that a biosecurity audit be conducted by an auditing team comprised of an auditor and a reviewer using the biosecurity audit tool available at https://www.aphis.usda.gov/sites/default/files/biosecurityaudit.pdf. The auditor makes the initial determination of whether a premises passes a biosecurity audit and will be a State employee. If the State lacks the human resources to fill the position, an APHIS employee can fill the position. The reviewer makes the final determination of whether a premises passes a biosecurity audit and will be an APHIS employee. The audit will be conducted as follows:

(i) Biosecurity audits for premises in a buffer zone as described in § 53.10(g)(1)(ii), shall be conducted virtually by an auditor unless the State Animal Health Official, in the State where the premises is located, requests an in-person audit.

(ii) Biosecurity audits for previously infected premises as described in § 53.10(g)(1)(iii), shall be conducted in-person by an auditor unless the State Animal Health Official determines that extenuating circumstances warrant a virtual audit instead. Extenuating circumstances include, but are not limited to, severe adverse weather conditions, employee safety considerations, and lack of necessary equipment on the premises to conduct a virtual audit.

(2) To assist auditors in conducting the biosecurity audit, producers must allow auditors access to their premises and access to documentation to review and verify whether the premises meets the minimum requirements of the biosecurity audit criteria described in the biosecurity audit tool. A premises will initially pass a biosecurity audit if the auditor determines that the minimum requirements are met for all biosecurity audit criteria in the biosecurity audit tool. Auditors will communicate all identified deficiencies to producers and collaborate, where appropriate, to identify solutions to resolve the identified deficiencies. Producers must provide timelines to auditors for remediation of all identified deficiencies. Auditors will submit the audit package to a reviewer based in the State where the premises is located.

(3) The reviewer will review the audit package for completeness, accuracy, and consistency with other audits and render a final audit determination of pass or fail. The reviewer must be afforded the same access to the premises previously afforded to the auditor, if requested.

(4) If the producer disagrees with the final audit determination, the producer may send a request for reconsideration to [email protected] or by postal mail to: Biosecurity Audit Reconsideration, 920 Main Campus Drive, Raleigh, NC 27606. The request for reconsideration must be in writing, state all the facts and reasons upon which the producer relies to show that the producer wrongfully failed the biosecurity audit, and be received by the Biosecurity Compliance Audit Program Manager within 14 calendar days of communication of the reviewer's final audit determination. After receipt of the reconsideration request, the process proceeds as follows:

(i) The Biosecurity Compliance Audit Program Manager will review the reconsideration request, the audit package prepared by the auditor, and the reviewer's final audit determination. If the Biosecurity Compliance Audit Program Manager determines that the producer wrongfully failed the biosecurity audit, he or she will change the final audit determination from fail to pass. The auditor will notify the producer of the change in writing, and the Biosecurity Compliance Audit Program Manager will close the reconsideration request. If the Biosecurity Compliance Audit Program Manager agrees that the producer failed the biosecurity audit, the reconsideration process will continue to a panel review.

(ii) A panel consisting of the State Animal Health Official of the State where the premises is located, the APHIS Area Veterinarian in Charge, and the Biosecurity Compliance Audit Program Manager will review the reconsideration request, the audit package prepared by the auditor, and the reviewer's final audit determination. The panel's decision is final and will be communicated to the producer as promptly as circumstances allow and will state, in writing, the reasons for the decision.

(5) A final audit determination of pass for a premises that had a biosecurity audit conducted in accordance with paragraph (f)(1)(i) or (ii) of this section will be valid for six (6) months, unless the premises changes its poultry biosecurity plan, biosecurity coordinator, ownership, or infrastructure. If such premises makes any of the aforementioned changes, the premises must pass a new biosecurity audit conducted in accordance with paragraph (f)(1)(i) or (ii) of this section, as applicable, prior to the movement of poultry onto the premises.

(6) The biosecurity audit tool referenced in paragraph (f)(1) of this section will be reviewed by APHIS on an annual basis and revised as follows:

(i) Standard process for revising the biosecurity audit tool. If the Administrator determines that revisions to the biosecurity audit tool are necessary, APHIS will publish a notice in the Federal Register advising the public of the Administrator' determination. The notice will describe the proposed revisions and the reasons for the proposed revisions and will invite public comment on the proposed revisions.

(ii) Immediate process for revising the biosecurity audit tool. If the Administrator determines that the biosecurity audit tool is no longer sufficient for auditors to use to conduct biosecurity audits pursuant to paragraph (f)(1)(i) or (ii) of this section, APHIS will immediately update the biosecurity audit tool. APHIS will publish a notice in the Federal Register advising the public of the Administrator's determination. The notice will specify the revisions and the reasons for the revisions, provide an effective date for the revisions, and will invite public comment on the revisions.

(g) Proposed updates to the NPIP Program Standards will be announced to the public through a Federal Register notice, as described in § 147.53(e) of this chapter.