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[Federal Register Volume 89, Number 250 (Tuesday, December 31, 2024)]
[Rules and Regulations]
[Pages 106981-106996]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-31384]

[[Page 106981]]

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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Part 53

[Docket No. APHIS-2023-0088]
RIN 0579-AE79

Payment of Indemnity and Compensation for Highly Pathogenic Avian 
Influenza

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Interim rule and request for comments.

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SUMMARY: We are amending the regulations pertaining to conditions for 
payment of indemnity for highly pathogenic avian influenza (HPAI). 
Specifically, we are requiring commercial poultry premises to 
successfully pass a biosecurity audit prior to restocking if they were 
previously HPAI-infected and wish to be eligible for indemnity for the 
restocked poultry. We are also requiring a biosecurity audit for 
commercial poultry premises in the buffer zone prior to movement of 
poultry onto the premises, if the premises wishes to be eligible for 
indemnity for the poultry moved onto the premises. We are also revising 
the regulations to preclude indemnity payments for poultry moved onto 
premises in infected zones if the poultry become infected with HPAI 
within 14 days following the dissolution of the control area in which 
the infected zone is located. This action is necessary on an immediate 
basis in order to ensure that commercial poultry producers who receive 
indemnity payments for HPAI are taking measures to preclude the 
introduction and spread of HPAI, and avoiding actions that contribute 
to its spread. This action amends the regulations to condition 
indemnity for HPAI accordingly.

DATES: This interim rule is effective December 31, 2024. We will 
consider all comments that we receive on or before March 3, 2025.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to www.regulations.gov. 
Enter APHIS-2023-0088 in the Search field. Select the Documents tab, 
then select the Comment button in the list of documents.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2023-0088, Regulatory Analysis and Development, PPD, 
APHIS, Station 2C-10.16, 4700 River Road, Unit 25, Riverdale, MD 20737-
1238.
    Supporting documents and any comments we receive on this docket may 
be viewed at Regulations.gov or in our reading room, which is located 
in room 1620 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. Leonardo L. Sevilla, DVM, 
Veterinary Medical Officer, Poultry Health Team, VS Strategy and Policy 
Aquaculture, Swine, Equine, and Poultry (ASEP), ASEP Health Center, 920 
Main Campus Drive, Raleigh, NC 27606; (984) 766-1528; 
[email protected].

SUPPLEMENTARY INFORMATION:

Background

    The Animal and Plant Health Inspection Service (APHIS) of the 
United States Department of Agriculture (USDA or the Department) 
administers regulations at 9 CFR part 53 (referred to below as the 
regulations) that provide for the payment of indemnity to owners of 
animals that are required to be destroyed because of foot-and-mouth 
disease, pleuropneumonia, Newcastle disease, highly pathogenic avian 
influenza (HPAI), infectious salmon anemia, spring viremia of carp, or 
any other communicable disease of livestock or poultry that, in the 
opinion of the Secretary of Agriculture, constitutes an emergency and 
threatens the U.S. livestock or poultry population. Payment for animals 
destroyed is based on the fair market value of the animals at the time 
of their destruction.
    Section 53.2 of the regulations authorizes the APHIS Administrator 
to cooperate with a State in the control and eradication of disease, as 
that term is defined in Sec.  53.1. Section 53.2(b) allows for payments 
to cover the costs for purchase, destruction, and disposition of 
animals required to be destroyed because of being infected with or 
exposed to such disease. Section 53.10 of the regulations provides 
conditions under which indemnity claims are not allowed, whereas Sec.  
53.11 provides conditions under which payment will be made on indemnity 
claims resulting from HPAI outbreaks.

HPAI Outbreaks and Responses

    HPAI is an extremely infectious and fatal form of avian influenza 
in poultry. An HPAI outbreak can have significant consequences for the 
poultry industry, wildlife, and producers' livelihoods, as well as 
significant impacts on international trade in poultry and poultry 
products. Certain strains of avian influenza have the potential to 
affect humans. An HPAI outbreak in poultry in the United States is 
declared when the first case in domestic poultry meets the case 
definition of HPAI as defined in USDA APHIS' National List of 
Reportable Animal Diseases (NLRAD) (https://www.aphis.usda.gov/sites/default/files/avian-influenza-case-definition.pdf). Stakeholders are 
notified of HPAI outbreaks through several routes of information; for 
example, online announcements are posted on the APHIS website at: 
https://www.aphis.usda.gov/news. Additionally, pursuant to the World 
Organization for Animal Health (WOAH) standards,\1\ at the onset of an 
HPAI outbreak in the United States, national level outbreak information 
is posted on the World Animal Health Information System.\2\ The HPAI 
outbreak applies to the entire country, and to the State in which the 
initial premises that tested positive is located. The outbreak ends in 
a specific State when the State regains freedom from HPAI pursuant to 
the WOAH standards. WOAH does not grant official recognition of freedom 
from HPAI in poultry. Per WOAH standards, the national HPAI outbreak 
ends when the United States declares freedom from HPAI in poultry by 
providing evidence demonstrating that the requirements for the disease 
status have been met in accordance with WOAH standards. Specifically, 
an outbreak ends when the country provides scientific data that 
explains the epidemiology of avian influenza in the region concerned 
and also demonstrates how all the risk factors are managed. This 
includes proof of effective surveillance strategies that mitigate the 
introduction of HPAI. The United States cannot declare freedom from 
HPAI in poultry for the entire country if HPAI exists in poultry in any 
State or territory within the country.
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    \1\ Countries declare freedom from HPAI by providing evidence 
demonstrating that the requirements for the disease status have been 
met in accordance with WOAH standards found here:
    https://www.woah.org/fileadmin/Home/eng/Health_standards/tahc/2023/chapitre_avian_influenza_viruses.pdf. For more information on 
eradication see https://www.aphis.usda.gov/sites/default/files/hpai_response_plan.pdf.
    For more information on control area release see https://www.aphis.usda.gov/sites/default/files/control_area_release.pdf.
    \2\ For more information on reporting outbreaks see WAHIS--
https://wahis.woah.org/#/home.
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    Beginning in December 2014, the U.S. poultry industry experienced a 
severe outbreak of HPAI, discovered in

[[Page 106982]]

backyard flocks in the Pacific Northwest, and in two commercial turkey 
and chicken flocks in California. APHIS issued a final July 2015 report 
of the 2014-2015 outbreak, (https://www.aphis.usda.gov/animal_health/emergency_management/downloads/hpai/2015-hpai-final-report.pdf), 
regarding surveillance and other response services by APHIS, which has 
been provided to the public. APHIS determined that from January 2015 to 
March 2015, the disease spread slowly to multiple States, including 
Minnesota, Missouri, Arkansas, and Kansas. In June 2015, the last case 
of HPAI was confirmed in a commercial flock. However, the cost 
associated with response activities was the most expensive animal 
health incident recorded in U.S. history. The final cost associated 
with the 2014-2015 outbreak was nearly $1 billion. The cost obligated 
for response activities totaled $650 million and indemnity payments 
totaled $200 million, and an additional $100 million was made available 
for further preparedness activities.
    The impact of the 2014-2015 HPAI outbreak spread beyond financial 
resources and economic concerns. The outbreak resulted in regulatory 
revisions to address biosecurity \3\ concerns identified during the 
outbreak. In the July 2015 report, APHIS determined that, amongst other 
factors, poor biosecurity was responsible for the introduction of HPAI 
into some commercial poultry facilities. More specifically, APHIS 
stated in the report that ``biosecurity measures must be improved on 
premises to not only stop HPAI transmission during an outbreak but 
prevent HPAI introductions into commercial poultry flocks in the 
future.'' Biosecurity basics are aimed at evaluating a premises for 
possible introduction of disease onto the premises, and taking 
appropriate mitigations to address these possible sources of 
introduction and to limit the spread of disease, if introduced. Within 
the context of HPAI, these include, but are not limited to, the 
following: (1) Keeping visitors on the premises to a minimum (HPAI can 
be transmitted by fomites, such as clothing); (2) washing hands before 
coming in contact with live poultry (HPAI virus can be transmitted by 
persons coming into physical contact with affected poultry); (3) 
cleaning/disinfecting tools or equipment before moving them to a new 
poultry facility (HPAI virus can survive on the surfaces of farm 
equipment, including tools and means of conveyance); and (4) removing 
wild bird nesting and harborage, preventing access of wild birds to 
poultry enclosures, and precluding wild birds from coming in contact 
with feed used at the premises (as discussed below, wild birds can be a 
significant pathway for the spread of HPAI). APHIS poultry biosecurity 
recommendations can be found at: https://www.aphis.usda.gov/livestock-poultry-disease/avian/defend-the-flock.
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    \3\ ``Biosecurity'' refers to everything people do to keep 
diseases--and the viruses, bacteria, funguses, parasites, and other 
microorganisms that cause disease--away from birds, property, and 
people. Biosecurity includes both structural biosecurity and 
operational biosecurity. Structural Biosecurity refers to measures 
used in the physical construction and maintenance of coops, pens, 
poultry houses, family farms, commercial farms, and other 
facilities. Operational Biosecurity refers to practices, procedures, 
and policies that people follow consistently. For more information 
see https://www.aphis.usda.gov/livestock-poultry-disease/avian/defend-the-flock.
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    During the 2014-2015 outbreak, APHIS initially paid full indemnity 
to bird owners of poultry infected with HPAI, regardless of whether or 
not the owners had a biosecurity plan in place at their facilities at 
the time of introduction. In response, APHIS amended the regulations, 
in an interim rule published in the Federal Register, and effective, on 
February 9, 2016, (81 FR 6745-6751, Docket No. APHIS-2015-0061),\4\ 
pertaining to conditions for payment of HPAI indemnity claims. We added 
a requirement for owners and contractors to provide a statement that at 
the time of detection of HPAI in their facilities, they had in place 
and were following a poultry biosecurity plan. Section 53.1 defines a 
``poultry biosecurity plan'' as ``[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.'' The interim rule also 
exempted owners and contractors from this requirement if any of the 
following apply:
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    \4\ To view the interim rule, its supporting documentation, or 
the comments that we received, go to https://www.regulations.gov/docket/APHIS-2015-0061.
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     Premises meet the size criteria of the National Poultry 
Improvement Plan (NPIP) \5\ regulations in that they are either:
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    \5\ NPIP is a cooperative Federal-State-industry certification 
program administered by APHIS. For more information on NPIP, see 
https://www.poultryimprovement.org.
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    [cir] Commercial table-egg laying premises with fewer than 75,000 
birds;
    [cir] Egg-type game bird and egg-type waterfowl premises with fewer 
than 25,000 birds;
     Premises on which fewer than 100,000 broilers are raised 
annually; or
     Premises on which fewer than 30,000 meat turkeys are 
raised annually.
    We took comment on the interim rule for 60 days, ending April 11, 
2016. In response to comments received during the comment period, in a 
final rule published in the Federal Register on August 15, 2018 (83 FR 
40433-40438, Docket No. APHIS-2015-0061),\6\ we amended Sec.  53.11 of 
the regulations to require biosecurity plan audits. Specifically, the 
final rule required facilities that are subject to the provisions of 
the 2016 interim rule to have their biosecurity plans audited at least 
once every 2 years. The final rule also subjected facilities to 
additional audits, as needed, during this biennial period to satisfy 
their Official State Agency (OSA). The OSA is the State authority that 
we recognize as a cooperator in the administration of the requirements 
of the NPIP. While this auditing mechanism was recommended by the 
comments on the 2016 interim rule, it is worth noting that the auditing 
mechanism was also recommended by NPIP at their 2016 biennial 
conference.\7\ As part of the audit, the OSA will, at minimum, evaluate 
the poultry biosecurity plan itself, which will include an evaluation 
of the poultry biosecurity plan against 14 biosecurity principles 
articulated in the NPIP Program Standards policy document,\8\ and 
review the documentation showing that the poultry biosecurity plan is 
being implemented.
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    \6\ To access the 2018 final rule, go to https://www.regulations.gov/document/APHIS-2015-0061-0021.
    \7\ For more information on the NPIP biennial conference, see 
https://www.poultryimprovement.org/.
    \8\ Approved biosecurity principles are listed in the NPIP 
Program Standards found here: https://www.poultryimprovement.org/documents/ProgramStandardsA-E.pdf.
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    APHIS believed that the provisions of the 2016 HPAI indemnity rule, 
as amended to include this auditing provision, would be sufficient to 
reduce spread of the virus in the event of another HPAI outbreak.

The 2022-2024 HPAI Outbreak and the Need for Revised Auditing 
Procedures

    Our experience with a subsequent outbreak of HPAI in poultry in 
2022-2024 has indicated that the 2016 interim rule and the subsequent 
2018 final rule were insufficient to address initial introduction of 
HPAI into flocks on premises in proximity to an infected premises, or 
subsequent reintroduction of HPAI into flocks on premises previously 
infected with HPAI. As of

[[Page 106983]]

November 2024, the costs associated with the ongoing outbreak have 
exceeded $1.4 billion, including $1.25 billion in indemnity and 
compensation payments. Of this, APHIS has spent approximately $227 
million on indemnity payments to premises that have been infected 
multiple times with HPAI. A total of 67 unique commercial poultry 
premises have been infected at least twice with HPAI during the current 
outbreak, including 19 premises that have been infected 3 or more 
times.
    While reinfections may occur with even a perfectly implemented 
biosecurity plan, the data suggest that the current paper-based audit 
process does not always illustrate how well the premises are practicing 
biosecurity to prevent HPAI infection or reintroduction. To determine 
how well a biosecurity plan is being implemented, a visual inspection 
of the poultry premises is necessary. We discuss this at greater length 
later in this document.
    In April 2022, APHIS issued a HPAI response guidance for the 
current outbreak.\9\ This guidance has assisted with addressing the 
current outbreak, however gaps in the implementation of biosecurity 
measures to mitigate the risk of HPAI spread and introduction exist. 
The current guidance only covers biosecurity audits for premises moving 
poultry into the buffer zone. This interim rule includes biosecurity 
requirements for previously infected premises and codifies restocking 
guidelines for those premises. The current guidance fails to address 
restocking audits for previously infected premises, that are currently 
implemented on a State-by-State basis. APHIS has found that some States 
do not have a restocking policy. Furthermore, epidemiological data 
shows continued reinfection after the 2022 guidance was implemented. 
The guidance discourages movement and encourages and requires a higher 
level of biosecurity within an infected zone, this interim rule 
provides specifics for the biosecurity audit process and helps ensure 
that proper biosecurity measures are being implemented within infected 
zones and by previously infected premises to mitigate future 
infections.
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    \9\ For more information on APHIS' HPAI response, see https://www.aphis.usda.gov/sites/default/files/permitting-live-poultry-infected-zone.pdf.
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    First, we have learned more about how proximity of poultry premises 
impacts HPAI spread.\10\ During the 2014-2015 HPAI outbreak, States 
designated ``control areas'' as the perimeter of at least 10 kilometers 
(km) beyond the perimeter of the premises infected with HPAI. Control 
areas consist of an infected zone and a buffer zone. The infected zone 
is the area that immediately surrounds an infected premises, up to the 
beginning of the buffer zone. The buffer zone has typically been 
identified as an uninfected zone situated 3-10 km around an infected 
premises. The size of control areas is based on several factors 
including, but not limited to, the infected premises transmission 
pathways and estimates of transmission risk, poultry movement patterns 
and concentrations, distribution of susceptible wildlife in proximity, 
natural terrain, and jurisdictional boundaries.\11\ The boundaries of 
control areas can be modified or redefined when tracing and other 
epidemiological information becomes available. Premises that are 
located in the infected zone and buffer zone of a control area are 
usually notified of this status by the State Animal Health Official 
(SAHO), although within this interim rule we are making allowance for 
notification by APHIS instead.
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    \10\ For HPAI Depopulation Analysis Report, see https://www.aphis.usda.gov/sites/default/files/hpai-2022-2023-summary-depop-analysis.pdf.
    \11\ For more information on control area size consideration, 
see https://www.aphis.usda.gov/sites/default/files/hpai_response_plan.pdf.
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    During the current outbreak, it has become increasingly clear that 
premises within the infected zone and the buffer zone are at a higher 
risk of becoming infected with HPAI than premises outside of the 
control area.\12\ In June 2023, an epidemiological analysis found that 
wild bird introductions were the primary means of spread during this 
current poultry outbreak. To improve the understanding of risk factors 
associated with HPAI on table egg farms and turkey farms in the United 
States, case-control studies were conducted identifying risk factors 
for HPAI and biosecurity challenges. The most significant farm-level 
risk factor for HPAI on table egg farms was being located within an 
existing control area. For turkey farms, the farm-level risk factors 
also included seeing wild waterfowl on the farm, farm location near a 
wetlands, seeing wild waterfowl or shorebirds on the closest waterbody, 
and not having a restroom facility available to crews visiting the 
farm. In addition, having feed or feed ingredients accessible to wild 
birds was identified as a risk factor. This risk may be heightened by a 
lack of protocol to clean spilled feed and/or presence of water around 
the premises where wild birds may congregate; both of these factors can 
serve as wild bird attractants to a premises. The findings confirm the 
need for both biosecurity and surveillance on poultry farms near an 
infected premises, to prevent infection and ensure rapid detection, 
whether the virus is likely spreading by wild birds or laterally 
between farms. Because premises in control areas are at a higher risk 
of being infected with HPAI, adequate biosecurity measures need to be 
implemented on these premises to prevent the introduction and spread of 
HPAI from premises to premises within the control area, and from 
premises within the control area to premises outside the control area.
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    \12\ For report of epidemiologic and other analysis of HPAI 
affected poultry, see https://www.aphis.usda.gov/sites/default/files/epi-analyses-avian-flu-poultry-2nd-interim-rpt.pdf.
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    Second, we have learned that, for premises in control areas and 
premises that have had previous introductions of HPAI within the same 
outbreak (that is, from the start of the outbreak until the HPAI 
outbreak is declared eradicated nationally pursuant to the WOAH 
standards as described above) biennial paper-based audits are 
insufficient. Paper-based audits alone do not enable us to determine 
whether a premises has sufficient biosecurity measures in place to 
reduce the risk of introduction or reintroduction of HPAI. Our 
experiences have indicated that the effectiveness of a poultry 
biosecurity plan is determined not only by its provisions, but also by 
how well the plan is implemented. Visual inspection of the premises is 
needed to evaluate how well the plan is implemented.
    Effective implementation of a poultry biosecurity plan can directly 
influence the amount of indemnity that APHIS pays. Effective 
implementation of a poultry biosecurity plan likely reduces the risk of 
introduction of HPAI onto a premises and mitigates its spread, if 
introduced. Less risk of HPAI introduction and spread would, in turn, 
reduce the need to destroy birds and thus reduce the need of APHIS to 
make indemnity payments. As noted previously, since 2022, APHIS has 
spent approximately $227 million on indemnity payments to premises that 
have been infected multiple times with HPAI. A total of 67 unique 
commercial poultry premises have been infected at least twice with HPAI 
during the current outbreak, including 19 premises that have been 
infected 3 or more times. In addition, there are two non-commercial 
premises that have had repeat HPAI infections. Based on epidemiologic 
findings in the ongoing 2022-2024 outbreak, biosecurity improvements 
reduced the likelihood of a premises contracting HPAI, as compared to 
farms that were infected with HPAI. However, the current

[[Page 106984]]

outbreak has surpassed the 2014-2015 outbreak as the largest animal 
health emergency in U.S. history, and APHIS' experiences to date in 
2024 indicate that the risk of introduction of HPAI onto premises 
persists.
    This interim rule will serve to reduce the risk that a producer 
becomes inclined to disregard biosecurity because they believe that 
APHIS will continue to cover the costs associated with damages related 
to an HPAI outbreak through indemnity payments regardless of their 
biosecurity status. The current regulations do not provide a sufficient 
incentive for producers in control areas or buffer zones to maintain 
biosecurity throughout an outbreak. The current regulations provide for 
indemnity for poultry that are depopulated, without visually confirming 
that the premises are taking appropriate biosecurity measures to 
prevent future infection and spread. The compensation provided covers 
the value of the poultry that would otherwise be of, at most, minimal 
salvage value because they would have likely died naturally because of 
HPAI infection. Conversely, a flock may need to be depopulated before 
it has reached maturity, and a producer could maximize the profit 
associated with its poultry and products. The requirements of this 
interim rule will address both of these issues in the current 
regulations: Indemnity will now be conditioned in certain instances on 
visual evaluation of biosecurity, and adequate biosecurity, in turn, 
will increase the likelihood that poultry reach the age of maturity for 
the product (e.g., table eggs, hatching eggs, meat, etc.) they are 
being marketed for. As of November 2024, APHIS has spent approximately 
$296 million on indemnity and response payments to premises infected 
multiple times during the 2022-2024 outbreak, and an estimated $128 
million in indemnity and response payments for premises that were 
infected while in a buffer zone. This interim rule allows APHIS to 
restrict indemnity payments to those previously infected producers and 
those producers in buffer zones who have undergone biosecurity audits 
to verify biosecurity measures, thereby reducing the incentive to 
undertake that risky behavior.

HPAI in Dairy Cattle

    In March 2024, a development occurred relative to the lateral 
spread of HPAI that further underscored the need for revision to the 
indemnity regulations in poultry: HPAI was detected in dairy cattle. 
Typically, HPAI is sporadically detected in mammals, particularly those 
with close contact to infected poultry and wild birds, those that share 
feed or water sources, or those that scavenge carcasses. However, the 
confirmation of HPAI in dairy cattle in late March 2024, and the 
subsequent transmission of the disease within and between dairy herds, 
marked a significant change in the epidemiology of HPAI. The presence 
of HPAI in cattle also posed another potential source of the virus for 
poultry flocks. USDA and State teams have conducted extensive 
epidemiological work to investigate the links between HPAI-affected 
dairy premises and spillover into poultry premises. Data collected 
since March 2024 indicates that virus can be transmitted on equipment, 
people, or other items that move from farm to farm. Epidemiological 
investigations identified the potential factors for the transmission 
between premises as the movement of livestock, numerous people, 
vehicles, and other farm equipment frequently moving on and off an 
affected premises and on to other premises, often a part of normal 
business operations. In particular, transmission factors include shared 
equipment which is not cleaned between farms; contaminated equipment; 
shared personnel and housing; frequent visitors with access to animals; 
and presence of other species on farms.\13\
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    \13\ For more information on transmission, see https://www.aphis.usda.gov/sites/default/files/highly-pathogenic-avian-influenza-national-epidemiological-brief-09-24-2024.pdf.
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    Additionally, since April 2024, several cases in workers on 
affected dairy and poultry premises have been reported. The fact that 
shared personnel, frequent visitors, vehicles and other equipment are 
transmission factors may indicate the inadequacy of current biosecurity 
measures (e.g., inadequate cleaning and disinfection of personnel and 
vehicles prior to leaving an infected premises and/or inadequate 
restriction of movement on and off premises, all foundational 
components of biosecurity, could allow transmission of HPAI to a new, 
previously uninfected premises).

Regulatory Revisions

    APHIS is amending Sec.  53.10 to require biosecurity audits for two 
statuses of poultry premises in order for owners and/or contractors 
(hereafter collectively referred to in this section of the preamble as 
``producers'') to qualify for indemnity arising out of the destruction 
of poultry destroyed due to an outbreak of HPAI. One status of poultry 
premises for which this interim rule will require biosecurity audits 
are premises located in the buffer zone of a control area for HPAI. If 
a producer intends to move poultry onto a premises located in a buffer 
zone and wishes the poultry moved onto the receiving premises to be 
eligible for future indemnity payments in the event that the receiving 
premises is later infected with HPAI and the poultry must be destroyed, 
the receiving premises must pass a biosecurity audit. If the receiving 
premises passed a biosecurity audit within the six (6) months preceding 
the intended date of movement of the poultry onto the receiving 
premises, a new biosecurity audit is unnecessary. The audit will be 
done virtually unless the SAHO requests an in-person audit.
    The other status of poultry premises for which this interim rule 
will require biosecurity audits are previously infected premises. If 
producers intend to restock the previously infected premises, that 
premises must pass a biosecurity audit prior to the movement of poultry 
onto the premises. In order for the premises to maintain eligibility 
for indemnity for a future infection within the same outbreak, the 
premises must pass a virtual biosecurity audit every six (6) months, 
until the State in which the premises is located, declares freedom from 
HPAI. As discussed previously, to declare freedom from HPAI, the State 
must provide the relevant epidemiological evidence that shows proof of 
an effective surveillance program and demonstrate, through testing, an 
absence from infection in susceptible poultry populations in that 
State.
    Through requiring a biosecurity audit as a condition to receiving 
indemnity for the destruction of poultry on premises located in the 
buffer zone and previously infected premises, these regulatory 
revisions will incentivize producers to ensure that their commercial 
poultry premises are implementing and maintaining appropriate poultry 
biosecurity plans. As previously discussed, enhanced compliance with 
poultry biosecurity plans is expected to mitigate the introduction and 
spread of HPAI.
    APHIS is also amending Sec.  53.11 to set forth the process for 
conducting the biosecurity audits required by Sec.  53.10, including 
use of the biosecurity audit tool, the process for reconsideration of a 
final audit determination, and the process for revising the biosecurity 
audit tool.
    In addition, APHIS is also amending Sec.  53.1 to add definitions 
for the terms ``buffer zone,'', ``control area,'' and ``infected 
zone,'' which are used in amended Sec.  53.10 and/or Sec.  53.11.
    The specific nature of the revisions is discussed immediately 
below.

[[Page 106985]]

Revisions to Sec.  53.10 and Sec.  53.1

    As we noted above, Sec.  53.10 of the regulations provides 
conditions under which indemnity claims are not allowed. We are only 
proposing changes to Sec.  53.10(g).
    We are proposing some minor changes to Sec.  53.10(g)(1). All 
references to the word ``animals'' in this section is being changed to 
``poultry'' for clarity. Additionally, we are breaking up Sec.  
53.10(g)(1). Revised Sec.  53.10(g)(1) will solely contain the 
introductory language indicating that APHIS will not allow indemnity 
claims unless certain conditions are met and the first condition of 
having in place and following a poultry biosecurity plan is moved to 
new Sec.  53.10(g)(1)(i).
    We are also revising Sec.  53.10(g) to provide several additional 
conditions under which indemnity claims are not allowed. Under new 
Sec.  53.10(g)(1)(ii), APHIS will not pay indemnity for the destruction 
of poultry destroyed due to an outbreak of HPAI for poultry moved onto 
a premises located in a buffer zone of a control area unless the 
premises passes a biosecurity audit conducted in accordance with new 
Sec.  53.11(f)(1)(i) prior to the movement of poultry on the premises; 
or the premises passed a biosecurity audit within the preceding six (6) 
months. Under certain circumstances, the Administrator may, upon 
request by the producer, permit audits to be conducted after the 
poultry is placed onto the premises if the Administrator determines 
that such action will not result in the dissemination of HPAI within 
the United States. For example, poultry may be in transit prior to the 
receiving premises being notified of its buffer zone status, preventing 
an audit to be conducted before the poultry arrives on the premises. To 
ensure the welfare of the poultry, the receiving premises may be 
required to accommodate the poultry prior to passing a biosecurity 
audit. If the request for an audit after the poultry is placed onto a 
premises is denied, the premises will not be eligible to receive future 
indemnity payment for the poultry placed on the premise until the 
premises passes a biosecurity audit conducted in accordance with new 
Sec.  53.11(f)(1)(i) if the poultry are placed irrespective of the 
Administrator's determination.
    Additionally, under new Sec.  53.10(g)(1)(iii), APHIS will not pay 
indemnity for the destruction of poultry destroyed due to an outbreak 
of HPAI for poultry moved onto a premises that has previously been 
infected with HPAI during the same outbreak, unless the premises passed 
a biosecurity audit conducted in accordance with new Sec.  
53.11(f)(1)(ii) prior to the movement of poultry onto the premises. 
APHIS views an occurrence of HPAI as being during the same outbreak if 
it occurs before the HPAI outbreak is declared eradicated nationally, 
pursuant to the WOAH standards as described above; unless the movement 
occurs after the U.S. declares freedom from HPAI. We appreciate that an 
outbreak may span several years; however, effective biosecurity is 
possible throughout the duration of an outbreak. This is evidenced by 
the many premises that have not had a single introduction of HPAI 
during the current outbreak, despite the presence of risk factors for 
HPAI introduction, such as being in the flyway of migratory wild birds.
    Notwithstanding the impact this outbreak has had on financial 
resources and the continuing economic concerns, this interim rule is 
not retroactive. Once issued, infections which were detected prior to 
the publication will not be considered in the statuses of premises. 
Further, upon publication, a small number of premises may find 
themselves located within a buffer zone. If these premises have 
scheduled movements which occur within a few days of the rule 
publication, they would have two options to satisfy the rule's 
requirements: (1) If possible, delay the shipment until an audit can be 
performed or (2) utilize Sec.  53.10(g)(1)(ii) to request a post-
placement audit from the Administrator (if the shipment cannot be 
delayed). All previously infected premises in a State must pass virtual 
biosecurity audits every six (6) months until the State in which the 
premises is located declares freedom from HPAI. The additional audits 
are based on APHIS' review of chronological outbreak data regarding 
date of all case detections relative to virus elimination and audit 
dates for known infected poultry premises. The data analysis indicated 
that previously infected premises that had biosecurity audits conducted 
on a voluntary basis did not have any HPAI introduction within 180 days 
post-audit and movement of poultry. Based on this data, APHIS found 
that the risk of HPAI reintroduction on a previously infected premises 
is low within 6 months. Additionally, the 180 days roughly aligns with 
wild bird migratory patterns, when increased risk of introduction from 
wild birds is elevated, and it would be appropriate to ensure poultry 
premises are implementing heightened biosecurity practices.
    As stated previously, the regulations currently exempt producers 
from having to develop and follow a poultry biosecurity plan as a 
condition of indemnity for HPAI if any of the following apply:
     Commercial table-egg laying premises with fewer than 
75,000 birds;
     Egg-type game bird and egg-type waterfowl premises with 
fewer than 25,000 birds;
     Premises on which fewer than 100,000 broilers are raised 
annually; or
     Premises on which fewer than 30,000 meat turkeys are 
raised annually.
    Because these premises are not currently required to develop and 
follow a poultry biosecurity plan, we are also exempting them from 
being required to pass a biosecurity audit. As we noted in the 2016 
interim rule, more than 97 percent of turkeys and 99 percent of 
broilers are raised on farms that are above these size thresholds. 
Additionally, whereas the regulations had previously cited the relevant 
provisions of the NPIP regulations for the first two size standards, to 
aid in readability of the section, we are removing the reference to the 
NPIP regulations and, in their place, adding the actual size standards 
that are being referenced. We are not changing the size standards 
themselves, simply restating them within Sec.  53.10(g)(2).
    Finally, we are adding a new paragraph (g)(3) to the section. This 
paragraph states that, notwithstanding the conditions in paragraphs 
(g)(1) and (2), the Department will not pay claims arising out of the 
destruction of poultry destroyed due to an outbreak of HPAI 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. 
The incubation period for HPAI viruses in naturally infected chickens 
ranges from 3-14 days. Once a control area is released, there is 
significantly less risk of disease spread caused by common-source 
lateral transmission.
    To clarify the scope of the new requirements to receive indemnity 
for poultry, we are adding definitions for buffer zone, infected zone, 
and control area to Sec.  53.1 of the regulations, which contains 
definitions of terms used in 9 CFR part 53. We are defining buffer zone 
as ``[t]he zone within a control area that immediately surrounds an 
infected zone.'' We are defining infected zone as ``[t]he zone within a 
control area that immediately surrounds a premises infected with highly 
pathogenic avian influenza, up to the beginning of the buffer zone.'' 
As we noted above, currently buffer zones are usually the area situated 
between 3 and 10 km from an infected premises, and the SAHO

[[Page 106986]]

determines and communicates to producers whether they are in the 
infected zone or the buffer zone, or outside of the control area 
entirely. However, to allow for the possibility of larger or smaller 
control areas, infected zones, and/or buffer zones in the future, we 
are not specifying a particular distance from the infected premises in 
our definitions. As previously stated, multiple factors are considered 
in determining control area size for HPAI, including infected premises 
transmission pathways and estimates of transmission risk, poultry 
movement patterns and concentrations, distribution of susceptible 
wildlife in proximity, natural terrain, and jurisdictional boundaries. 
We are defining control area as ``[t]he 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.'' Again, we 
envision that in most instances the SAHO will make the final 
determination for setting the perimeter of the control area and 
communicating the bounds of the control area to producers. This is, as 
noted above, the current practice. However, our definition does provide 
latitude for APHIS to determine and set the bounds of the control area. 
We envision that we will defer to the SAHO except in extraordinary 
circumstances, such as when a declaration of extraordinary emergency 
within the State has been made pursuant to 7 U.S.C. 8306(b) of the 
Animal Health Protection Act.
    The prohibition on indemnity claims that we are adding to the 
regulations in paragraph (g)(3) of Sec.  53.10 is warranted because, 
based on our definitions, poultry premises in the infected zone either 
are infected with HPAI or are in close proximity to an infected 
premises, and the incubation period for HPAI is up to 14 days. This 
additional requirement for future federal indemnity eligibility is 
necessary to limit movement of poultry into an area where poultry are 
at an increased risk for exposure and infection with HPAI.

Revisions to Sec.  53.11

    Section 53.11 provides conditions under which payment will be made 
on indemnity claims resulting from HPAI outbreaks. We are amending 
Sec.  53.11 to describe how the biosecurity audits, required by the 
revisions to Sec.  53.10(g), will be conducted. We are redesignating 
current paragraph (f) of the section as paragraph (g), and we are 
adding a new paragraph (f), which discusses the parameters surrounding 
and content of these biosecurity audits and how the biosecurity audit 
tool will be updated. The relevant biosecurity audit is determined by 
the status of a premises prior to movement of poultry onto that 
premises.
    New paragraph (f)(1) of Sec.  53.11 provides that APHIS requires a 
biosecurity audit to be conducted on the following poultry premises:
     For premises in a buffer zone, a biosecurity audit shall 
be conducted virtually by the auditor, unless the SAHO in the State 
where the premises is located requests an in-person audit. For example, 
if the facility lacks necessary equipment or IT infrastructure on the 
premises to conduct a virtual audit, a SAHO could request an in-person 
audit.
     For previously infected premises, a biosecurity audit 
shall be conducted in-person by the auditor, unless the auditor 
determines that extenuating circumstances warrant a virtual audit. 
Extenuating circumstances include, but are not limited to, severe 
adverse weather conditions and employee safety considerations. All 
previously infected premises must pass virtually conducted biosecurity 
audits every six (6) months after the initial in-person audit until the 
State in which the premises is located declares freedom from HPAI.
    We are allowing biosecurity audits of poultry premises in a buffer 
zone to be conducted remotely because, while the premises are at risk 
of becoming affected with HPAI, they are, by definition, currently 
uninfected but in proximity to infected premises, and because premises 
in the buffer zone, as a whole, undergo periodic surveillance. 
Surveillance activities include but are not limited to, gathering 
epidemiological information through observation and communication with 
other agencies. Active sampling of poultry is conducted on premises at 
control area establishment, then at set time intervals of 5-7 days (or 
more frequently if warranted) until the control area is closed. In 
addition, because premises in a buffer zone may have poultry onsite 
during a biosecurity audit, a virtual biosecurity audit helps to 
mitigate the risk of introduction of HPAI into the premises due to the 
increased vehicular and foot traffic on the premises from personnel 
that are conducting the audit. Moreover, in-person audits require more 
time and personnel resources and are logistically more complex compared 
to virtual audits. If the number of buffer zone audits conducted to 
date is an indication of what to expect as the current outbreak 
continues, mandating these audits to be in-person would stretch 
available resources that are already currently being utilized for other 
HPAI response activities and routine non-HPAI activities. For these 
reasons, a virtual visual inspection (which is conducted using a phone 
camera, computer, or other transmitting device) should usually suffice 
for the biosecurity audit of the premises itself. If a producer is 
unable to participate in a virtual inspection, due to lack of internet 
or a transmitting device at the premises, the audit may be conducted 
in-person.
    Conversely, because previously infected poultry premises have 
experienced an outbreak of HPAI and have the highest risk of 
reintroduction resulting from significant biosecurity lapses, we must 
verify how well the plan is implemented and maintained on site. In 
order to ensure that reintroduction risks are being effectively 
mitigated at previously infected premises, we are requiring that these 
biosecurity audits be conducted in person, absent extenuating 
circumstances. Examples of extenuating circumstances include, but are 
not limited to, severe adverse weather conditions and employee safety 
considerations. APHIS would require an in-person audit because once 
HPAI response activities are completed, including depopulation, the 
premises would not contain any poultry on the premises that would be at 
risk for HPAI from conducting the audit. With an in-person audit, APHIS 
will be able to be more meticulous in our approach of looking at the 
premises and ensuring that producers are taking appropriate biosecurity 
measures. Additionally, the absence of poultry on the premises 
eliminates any further risks of HPAI spread and introduction.
    APHIS considered, but did not pursue, two alternate options for the 
auditing process. One was to require more documentation, such as photos 
of the property, Google Earth\TM\ stills, and examples of signage, as 
part of an OSA paper-based review of the premises. However, this option 
was discarded because this approach does not allow for a holistic 
review of the maintenance and physical security of the structures at 
the facility, and it may not capture seasonal changes at the facility 
that could present a biosecurity risk. A second option considered was 
to conduct all audits virtually. This option was discarded for premises 
that have previously experienced an outbreak and wish to restock 
because the virtual audit is limited by what the phone camera, 
computer, or other transmitting device relays to the auditor. Given 
that previously infected premises have experienced an outbreak of HPAI, 
such

[[Page 106987]]

a limited view may not disclose all possible risks of reintroduction of 
HPAI to the premises, and require an in-person audit for better visual 
and auditory context, absent extenuating circumstances. To provide two 
examples that underscore the importance of in-person audits for visual 
and auditory context, a component of the audit involves evaluating 
whether feed and bedding at the facility may have been contaminated by 
exposure to rodents. Evidence (visual or auditory) of previous or 
current rodent infestation at the premises may be much easier to 
identify in person than virtually. Another component requires the 
inspector to inspect and/or monitor the enclosed structures housing 
live poultry to ensure sound construction and that they are kept in 
good repair. An in-person auditor may hear air circulation suggesting a 
hole or breach in the facility that would not necessarily be easy to 
detect through a virtual audit.
    To implement these two biosecurity audit processes within the 
Agency, APHIS developed the Biosecurity Compliance Audit Program 
(BCAP), which includes a BCAP Program Manager within APHIS' Veterinary 
Services program, and an auditing team comprised of an auditor and a 
reviewer. The auditor makes the initial determination of whether a 
premises passes a biosecurity audit. Generally, APHIS expects the 
auditor role will be filled by a State employee. However, if a State 
lacks the human resources to fill the position, an APHIS employee can 
fill the role. Conversely, the reviewer makes the final determination 
of whether a premises passes a biosecurity audit. This position will 
always be an APHIS employee because a final audit determination is an 
Agency decision that affects the eligibility of the producer to receive 
future indemnity payments for poultry destroyed due to HPAI. All 
biosecurity auditors and audit reviewers will undergo a USDA-led 
training program prior to being added to a team. The training includes 
ensuring consistent application of the biosecurity audit tool, 
awareness of different poultry production types and farm layouts, and 
different methods and technologies for implementation of biosecurity.
    During biosecurity audits, the audit team will conduct the audits 
using a biosecurity audit tool (https://www.aphis.usda.gov/sites/default/files/biosecurityaudit.pdf), developed by APHIS with State and 
industry input. From January 2024 through May 2024, industry provided 
APHIS with oral and written feedback regarding the operational 
feasibility of implementing on an ongoing basis a biosecurity audit 
checklist in use provisionally for poultry biosecurity audits conducted 
since the start of the current outbreak. The tool includes aspects of 
the current paper-based biosecurity audit that is conducted by OSA's on 
at least a biennial basis. In addition, the biosecurity tool was built 
upon the NPIP biosecurity criteria and the HPAI Control Area Placement 
Biosecurity Audit Checklist that was developed in 2022. As stated 
previously, as part of the biennial biosecurity audit, the OSA will, at 
a minimum, evaluate the poultry biosecurity plan itself, which includes 
an evaluation of the poultry biosecurity plan, against 14 biosecurity 
principles articulated in the NPIP Program Standards policy document, 
and review the documentation showing that the poultry biosecurity plan 
is being implemented. A member of the audit team will conduct this 
review as well. The audit tool also includes visual verification of 
perimeter buffer areas; line-of-separation (LOS) procedures for 
personnel, visitors, equipment, and vehicles; and on-premises rodent 
and wildlife mitigations, some of the 14 NPIP biosecurity principles. 
Use of the audit tool will ensure that audit teams consistently review 
premises and identify deficiencies in biosecurity. APHIS is making a 
copy of the tool available as a supporting document for this interim 
rule on Regulations.gov.
    Revisions to the audit tool are addressed in new Sec.  53.11(f)(6). 
The BCAP Program Manager will review the tool at least on an annual 
basis. As biosecurity audits are conducted and additional data is 
gathered, as updated epidemiological information becomes available, or 
as other advancements in technology and production practices occur, 
APHIS may determine that the audit tool needs to be revised. APHIS has 
two processes to revise the audit tool. Under the standard process, if 
the Administrator determines that revisions to the audit tool are 
necessary, APHIS will publish a notice in the Federal Register 
informing the public of our intention to amend the biosecurity audit 
tool. In the notice, APHIS will describe the proposed revisions to the 
audit tool, the reasons for the revisions, and provide a public comment 
period. Under the immediate process, the biosecurity audit tool will be 
immediately revised if the Administrator determines that the 
biosecurity tool is no longer sufficient for auditors to use to conduct 
biosecurity audits pursuant to new Sec.  53.11(f)(1)(i) or (ii). APHIS 
will update the audit tool and subsequently publish a notice in the 
Federal Register advising the public of the revisions and the reasons 
for the revisions, providing an effective date for the revisions, and 
providing for a public comment period.
    Under new Sec.  53.11(f)(2), the producer must allow auditors 
access to their premises (whether virtually or in-person) and access to 
documentation in order for the auditors to complete the biosecurity 
audit using the biosecurity audit tool. APHIS expects that any producer 
interested in moving poultry onto a premises in a buffer zone or onto a 
previously infected premises will contact APHIS to schedule the 
biosecurity audit. 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. If 
deficiencies are identified, the auditors will communicate the 
identified deficiencies to producers. Producers may ask clarifying 
questions about the nature of the deficiencies and/or provide 
additional documentation to remediate the identified deficiency. The 
auditor, where appropriate, may work with the producer to identify 
solutions to resolve the deficiencies and may revise the audit results 
based on the additional information provided. If the producer needs 
further guidance on addressing a deficiency that goes beyond the 
auditor's training, the auditor will send the request to the audit 
reviewer and, if needed, the BCAP Program Manager. Once the audit 
process concludes, the auditor will submit the audit package to a 
reviewer based in the State where the premises is located.
    New Sec.  53.11(f)(3) provides that the reviewer reviews the audit 
package for completeness, accuracy, and consistency with other audits. 
After review, the reviewer will render a final audit determination of 
pass or fail. To aid in that determination, the reviewer may request to 
view the premises in question to make virtual visual verifications; the 
reviewer must be afforded the same access previously afforded to the 
auditor. As provided in our previous discussion regarding Sec.  
53.10(g), premises are required to pass a biosecurity audit in order 
for the poultry on the premises to be eligible for indemnity.
    New Sec.  53.11(f)(4) provides a reconsideration process for failed 
outcomes of biosecurity audits. If the producer disagrees with the 
final audit determination of the reviewer, the producer may send a 
request for reconsideration to the BCAP Program Manager through email 
or by postal mail

[[Page 106988]]

to the addresses listed in the regulations. The request for 
reconsideration must be in writing, state the material facts and 
reasons upon which the producer relies to show that the producer 
wrongfully failed the biosecurity audit, and be received by the BCAP 
Program Manager within 14 calendar days of communication of the 
reviewer's final audit determination. After receipt of the 
reconsideration request, the BCAP Program Manager will review the 
reconsideration request, the audit package prepared by the auditor, and 
the reviewer's final audit determination. If the BCAP Program Manager 
disagrees with the reviewer's final determination the results of the 
biosecurity audit become a pass; if the BCAP Program Manager agrees 
that a biosecurity deficiency exists, the reconsideration request 
proceeds to panel review. A panel consisting of the SAHO of the State 
where the premises is located, the APHIS Area Veterinarian in Charge, 
and the BCAP 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 the outcome of 
the reconsideration process will be communicated to the producer, by 
the auditor, as promptly as circumstances allow and will state, in 
writing, the reasons for the decision.
    Finally, the duration of the validity of a biosecurity audit is 
addressed in new Sec.  53.11(f)(5). A final audit determination of pass 
will remain valid for six (6) months except for any premises that 
changes its biosecurity plan, biosecurity coordinator, ownership, or 
infrastructure during that six-month period. If such premises makes any 
of the aforementioned changes, the premises must pass a new biosecurity 
audit in accordance with Sec.  53.11(f)(1)(i) or (ii), as applicable, 
prior to the movement of poultry onto the premises. APHIS determined 
the length of time for which a biosecurity audit should be valid based 
on a review of data from the HPAI outbreak in poultry. The data 
indicated that since the onset of this current outbreak in 2022, the 
number of poultry premises located in buffer zones that had an HPAI 
introduction within 180 days of undergoing a biosecurity audit and 
moving birds onto the premises is less than 3 percent. Although data 
are limited based on the voluntary nature of the biosecurity audits, 
analysis of the chronological data for previously infected premises 
shows there was no indication that the previously infected premises had 
an HPAI introduction within 180 days post-audit and movement of 
poultry. Once this interim rule becomes effective, APHIS will continue 
to monitor this data to use in the Agency's decision-making process.

Immediate Action

    Immediate action is necessary to incentivize commercial poultry 
owners and contractors (hereafter referred to in this section of the 
preamble as ``producers'') to implement critical biosecurity measures 
to reduce the risk of introduction of HPAI and avoid actions that 
contribute to its spread. During the most recent HPAI outbreak, which 
began in 2022 and is ongoing, APHIS has learned more about the disease 
risk for poultry premises in proximity to other infected poultry 
premises and has discovered the limits of the current regulatory 
approach. APHIS modified guidance documents for the current outbreak; 
however, continued inconsistent application of biosecurity measures by 
producers despite the ongoing risk of introduction of HPAI from wild 
birds and nearby infected premises has resulted in continued repeat 
infections on some poultry premises. Since March 2024, APHIS has 
further encountered developments associated with spread of HPAI to, 
from, and within dairy cattle herds, as well as farm workers in contact 
with those herds. Cumulatively, all of these lessons learned from the 
2022-2024 outbreak underscore the need for immediate action to 
incentivize producers with at-risk premises, through conditioning 
indemnity payments on passing biosecurity audits, to take the necessary 
steps to implement biosecurity measures to mitigate the introduction 
and spread of HPAI, regardless of potential source of infection. 
Therefore, immediate action is needed to mitigate the introduction and 
spread of HPAI.
    Since 2016, APHIS has required that, as a condition for indemnity 
for poultry destroyed due to an HPAI outbreak, poultry producers above 
certain size thresholds must provide a statement that at the time of 
detection of HPAI in their premises, they had in place and were 
following a poultry biosecurity plan. Since 2018, APHIS has also 
required that the poultry biosecurity plans be audited at least once 
every 2 years by the producer's OSA. Recent lessons learned from the 
ongoing HPAI outbreak have highlighted that this regulatory approach is 
insufficient in certain instances and reinforced the importance of 
biosecurity in decreasing the chance of a virus introduction or 
reintroduction occurring in a premises or having the virus spread from 
premises to premises.
    First, we have learned more about how proximity to infected 
premises impacts HPAI spread. During an HPAI outbreak, States designate 
``control areas'' as the perimeter of at least 10 km beyond the 
perimeter of the poultry premises affected with HPAI. During this 
current outbreak, it has become increasingly clear that poultry 
premises within these control areas, consisting of an infected zone and 
a buffer zone, are at a higher risk of becoming infected with HPAI than 
premises outside of control areas. To improve the understanding of risk 
factors associated with HPAI on table egg farms and turkey farms in the 
United States, APHIS conducted case-control studies to identify risk 
factors for HPAI and biosecurity challenges.\14\ The findings confirm 
the need for both biosecurity and surveillance on poultry farms near an 
infected premises, to prevent infection and ensure rapid detection, 
whether the virus is likely spreading by wild birds or laterally 
between farms. Because premises in control areas are at a higher risk 
of being infected with HPAI, it is even more imperative that producers 
implement adequate biosecurity measures to prevent the introduction and 
spread of HPAI from premises to premises within the control area, and 
from premises within the control area to premises outside the control 
area.
---------------------------------------------------------------------------

    \14\ For more information on the case-control studies, see 
https://www.aphis.usda.gov/sites/default/files/hpai-challenges-implementing-biosecurity.pdf.
---------------------------------------------------------------------------

    Second, we have learned during this current outbreak that enhanced 
regulatory oversight of poultry premises in control areas is necessary 
to ensure that producers for which a poultry biosecurity plan is 
required are effectively implementing the poultry biosecurity plan. 
Currently, the regulations only require the poultry biosecurity plan to 
be audited every two (2) years or a sufficient number of times during 
that period to satisfy the producer's OSA. Additionally, the audits are 
currently paper-based. The current biennial audit failure rate is zero, 
however despite these biosecurity plans being present, APHIS has 
continued to see HPAI detections on poultry farms with a plan and 
epidemiologic findings on these premises show a failure of biosecurity 
in one or more areas. The effectiveness of a poultry biosecurity plan, 
however, is determined not only by its provisions (which is the focus 
of a paper-based

[[Page 106989]]

audit), but also by how well the plan is implemented and maintained on-
site.
    Through the current outbreak, APHIS has found that the 
effectiveness of a poultry biosecurity plan would likely be better 
evaluated by visual inspection of the premises in question, 
specifically visual inspection of the more at-risk premises in the 
control area. When producers fail to effectively implement and maintain 
their poultry biosecurity plan, the deficiencies can be quite 
pronounced and the consequences quite significant--namely that the 
premises gets infected with HPAI multiple times. In one particular 
case, APHIS determined that a producer had avoided the required 
biennial audits and had not effectively implemented a poultry 
biosecurity plan before HPAI was introduced onto the producer's 
premises. Ultimately, six premises owned by the same producer and 
within the same control area were infected with HPAI. Significant 
biosecurity lapses were also identified at each of the affected 
premises. Biosecurity deficiencies may also be a contributing factor to 
premises becoming reinfected with HPAI. During the current HPAI 
outbreak, a total of 67 unique commercial poultry premises have been 
infected with HPAI at least twice, including 19 premises that have been 
infected 3 or more times.
    Third, in March 2024, HPAI was detected in dairy cattle. Prior to 
this, HPAI was sporadically detected in mammals, particularly those 
with close contact to infected poultry and wild birds, those that share 
feed or water sources, or those that scavenge carcasses. However, the 
confirmation of HPAI in dairy cattle in late March 2024, and the 
subsequent transmission of the disease largely due to the interstate 
and regional movement of livestock, people, and equipment, marked a 
significant change in the epidemiology of HPAI and posed another 
potential source of the virus for poultry flocks.
    As of November 2024, APHIS and State teams have conducted extensive 
epidemiological work to investigate the links between HPAI-affected 
dairy premises and evidence of spillover into poultry premises. This 
new, distinct HPAI virus genotype poses a new animal disease risk as it 
can infect both cattle and poultry. The phylogenetic and 
epidemiological data indicate spread between dairy premises, and from 
dairy premises to poultry premises.\15\ While many factors contribute 
to transmission between premises, small amounts of unpasteurized milk 
from affected dairy animals can harbor high levels of virus and can be 
easily spread among dairy farms and between dairy and poultry farms 
through the movements of people, vehicles, trucks, and other animals 
including non-migratory, peridomestic birds. Poultry are much more 
susceptible to small amounts of virus that results in infection, which 
increases the potential for ongoing disease spread. Finally, since 
April 2024, several cases in workers on affected dairy and poultry 
premises have been reported.
---------------------------------------------------------------------------

    \15\ For more information on the phylogenetic and 
epidemiological data, see https://www.aphis.usda.gov/sites/default/files/hpai-dairy-faqs.pdf and https://www.aphis.usda.gov/livestock-poultry-disease/avian/avian-influenza/hpai-livestock.
---------------------------------------------------------------------------

    This recent lateral spread of HPAI within and between dairy herds 
and spillover into poultry flocks, poses increased risks of HPAI 
introduction and spread for poultry that effectively implemented 
poultry biosecurity plans may mitigate. Without the biosecurity audits 
for at-risk poultry premises to confirm effective implementation of 
poultry biosecurity plans as established by this interim rule, the 
spread of HPAI in the United States could escalate, not only in 
poultry, but also in other livestock, increasing the impact of the 
current outbreak. As demonstrated by the current outbreak, that impact 
extends beyond the economic implications for the livelihood of poultry 
producers to the physical health of individual workers who come into 
contact with infected animals. In response to the current outbreak in 
dairy cattle, APHIS has issued a second Federal Order to require 
national surveillance to continue to address the risk the disease in 
dairy cattle, and as a result, potential spread to other species. 
Escalation in the introduction and spread of HPAI needs to be addressed 
immediately.
    Under these circumstances, the Administrator has determined for 
good cause under 5 U.S.C. 553(b)(B) that prior notice and opportunity 
for public comment is impracticable and that there is good cause under 
5 U.S.C. 553(d)(3) for making this action effective less than 30 days 
after publication in the Federal Register.
    We will consider comments we receive during the comment period for 
this interim rule (see DATES above). After the comment period closes, 
we will publish another document in the Federal Register. The document 
will include a discussion of any comments we receive and any amendments 
we are making to the interim rule.

Executive Orders 12866, 13563, and Regulatory Flexibility Act

    This interim rule has been determined to be significant for the 
purposes of Executive Order 12866 as amended by Executive Order 14094, 
``Modernizing Regulatory Review,'' and, therefore, has been reviewed by 
the Office of Management and Budget (OMB).
    We have prepared an economic analysis for this interim rule. The 
economic analysis provides a cost-benefit analysis, as required by 
Executive Orders 12866 and 13563, which direct agencies to assess all 
costs and benefits of available regulatory alternatives and, if 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety effects, and equity). Executive Order 13563 
emphasizes the importance of quantifying both costs and benefits, of 
reducing costs, of harmonizing rules, and of promoting flexibility. The 
economic analysis also examines the potential economic effects of this 
interim rule on small entities, as required by the Regulatory 
Flexibility Act. The economic analysis is summarized below. The full 
analysis may be viewed on the Regulations.gov website (see ADDRESSES 
above for instructions for accessing Regulations.gov) or obtained from 
the person listed under FOR FURTHER INFORMATION CONTACT.
    APHIS is establishing requirements for certain poultry premises to 
complete a biosecurity audit as a condition for receiving indemnity 
payments for poultry depopulated because of an outbreak of HPAI. APHIS' 
response to HPAI via regulation is not new. In 2016, APHIS published an 
interim rule (81 FR 6745-6751, Docket No. APHIS-2015-0061) \16\ that 
amended Sec.  53.10 of the indemnity regulations to require producers 
provide, as a condition for receiving indemnity payments, a statement 
that at the time of HPAI detection on their premises, that they had in 
place and were following a poultry biosecurity plan consistent with 
NPIP biosecurity standards. In response to comments received during the 
comment period on the interim rule, in the final rule published in 
2018, APHIS amended Sec.  53.11 of the indemnity regulations to require 
poultry biosecurity plan audits at least once every 2 years or enough 
times during that period to satisfy the Official State

[[Page 106990]]

Agency.\17\ APHIS believed that the provisions of the 2016 HPAI 
indemnity rule, as amended to include this auditing provision, would be 
sufficient to reduce spread of the virus in the event of another HPAI 
outbreak. However, APHIS' experience with a subsequent outbreak of HPAI 
in 2022-2024 indicated that the 2016 interim rule and the subsequent 
2018 final rule were insufficient to address initial introduction of 
HPAI into flocks on premises in proximity to an infected premises, or 
subsequent reintroduction of HPAI into flocks on premises previously 
infected with HPAI.
---------------------------------------------------------------------------

    \16\ To view the interim rule, its supporting documentation, or 
the comments that we received, go to https://www.regulations.gov/docket/APHIS-2015-0061.
    \17\ To access the 2018 final rule, go to https://www.regulations.gov/docket/APHIS-2015-0061.
---------------------------------------------------------------------------

    This interim rule amends Sec.  53.10(g) to require biosecurity 
audits for two statuses of premises in order for owners and/or 
contractors (hereafter collectively referred to in this section of the 
preamble as ``producers'') to qualify for indemnity arising out of the 
destruction of poultry destroyed due to an outbreak of HPAI and that 
exceed defined size thresholds delineated by poultry type. One status 
of premises for which this interim rule will require biosecurity audits 
are premises located in a buffer zone of a control area for HPAI. If a 
producer intends to move poultry onto a premises located in a buffer 
zone and wishes the poultry moved onto the receiving premises to be 
eligible for future indemnity payments in the event that the receiving 
premises is later infected with HPAI and the poultry must be destroyed, 
the receiving premises must pass a biosecurity audit. If the receiving 
premises passed a biosecurity audit within the six (6) months preceding 
the intended date of movement of the poultry onto the receiving 
premises, a new biosecurity audit is unnecessary. The audit will be 
done virtually unless the SAHO requests an in-person audit. The other 
status of premises for which this interim rule will require biosecurity 
audits are previously infected premises. If producers intend to restock 
the previously infected premises, that premises must pass a biosecurity 
audit prior to the movement of poultry onto the premises. In order for 
the premises to maintain eligibility for indemnity for a future 
infection within the same outbreak, the premises must pass a virtual 
biosecurity audit every six (6) months, until the State in which the 
premises is located, declares freedom from HPAI.
    Current Sec.  53.10(g) exempts producers from having to develop and 
follow a poultry biosecurity plan as a condition of indemnity for HPAI 
if any of the following apply:
    The producer is a(n):
     commercial table-egg-laying premises with fewer than 
75,000 birds;
     egg-type game bird and egg-type waterfowl premises with 
fewer than 25,000 birds;
     premises on which fewer than 100,000 broilers are raised 
annually; or
     premises on which fewer than 30,000 meat turkeys are 
raised annually.
    Because these premises are not currently required to develop and 
follow a poultry biosecurity plan, in this interim rule, we are also 
exempting them from being required to pass a biosecurity audit. More 
than 97 percent of turkeys and 99 percent of broilers are raised on 
farms that exceed these size thresholds. However, flock size is non-
significantly associated with increased risk, provided that larger 
operations are more at risk than smaller operations in terms of number 
of poultry on the operation, not the implementation of a biosecurity 
plan.
    Regarding the defined size thresholds delineated by poultry type, 
current Sec.  53.10(g) cited the relevant provisions of the NPIP for 
the first two size standards. The NPIP is a cooperative Federal-State-
industry certification program administered by APHIS to promote 
biosecurity in poultry. To aid in readability and comprehension of the 
regulation, APHIS is removing the reference to the NPIP regulations 
and, in their place, adding the actual size standards that are being 
referenced. APHIS is not changing the size standards themselves, simply 
restating them within revised Sec.  53.10(g)(2).
    To clarify the scope of the new requirements to receive indemnity 
payments for poultry, APHIS is adding definitions for buffer zone, 
infected zone, and control area to Sec.  53.1 of the regulations, which 
contains definitions of terms used in part 53. APHIS is defining buffer 
zone as ``[t]he zone within a control area that immediately surrounds 
an infected zone.'' APHIS is defining infected zone as ``[t]he zone 
within a control area that immediately surrounds a premises infected 
with highly pathogenic avian influenza, up to the beginning of the 
buffer zone.'' APHIS is defining control area as ``[t]he 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.''
    Currently buffer zones are usually the area situated between 3 and 
10 km from an infected premises. However, to allow for the possibility 
of larger or smaller control areas, infected zones, and/or buffer zones 
in the future, APHIS does not specify a particular distance from the 
infected premises in the definitions. Multiple factors are considered 
in determining control area size for HPAI, including infected premises 
transmission pathways and estimates of transmission risk, poultry 
movement patterns and concentrations, distribution of susceptible 
wildlife in proximity, natural terrain, and jurisdictional boundaries.
    With respect to limitations on receipt of indemnity payments, APHIS 
is revising Sec.  53.10(g) to provide several additional conditions 
under which indemnity claims are not allowed. Specifically, APHIS will 
not pay indemnity for the destruction of poultry destroyed due to an 
outbreak of HPAI for poultry moved onto a premises located in a buffer 
zone of a control area unless the premises passes a biosecurity audit 
conducted in accordance with new Sec.  53.11(f)(1)(i) prior to the 
movement of poultry onto the premises. Premises that passed a 
biosecurity audit within the preceding 6 months are not required to 
pass a new audit. Additionally, under new Sec.  53.10(g)(1)(iii), APHIS 
will not pay indemnity for the destruction of poultry destroyed due to 
an outbreak of HPAI for poultry moved onto a premises that has 
previously been infected with HPAI during the same outbreak, unless the 
premises passed a biosecurity audit conducted in accordance with new 
Sec.  53.11(f)(1)(ii) prior to the movement of poultry onto the 
premises. APHIS views an occurrence of HPAI as being during the same 
outbreak if it occurs before the HPAI outbreak is declared eradicated 
nationally. Finally, APHIS will not pay indemnity claims arising out of 
the destruction of poultry destroyed due to an outbreak of HPAI 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.
    In this interim rule, APHIS is also amending Sec.  53.11 to set 
forth the process for conducting the biosecurity audits required by 
Sec.  53.10, including use of the biosecurity audit tool, the process 
for reconsideration of a final audit determination of fail, and the 
process for revising the biosecurity audit tool.
    For premises in a buffer zone, a biosecurity audit shall be 
conducted virtually by the auditor, unless the SAHO in the State where 
the premises is located requests an in-person audit. For previously 
infected premises, a

[[Page 106991]]

biosecurity audit shall be conducted in-person by the auditor, unless 
the auditor determines that extenuating circumstances warrant a virtual 
audit. Extenuating circumstances, include, but not limited to, severe 
adverse weather conditions and employee safety considerations. 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 HPAI.
    Under new Sec.  53.11(f)(1), APHIS requires biosecurity audits to 
be conducted as follows:
     For premises in a buffer zone, a biosecurity audit shall 
be conducted virtually by the auditor, unless the SAHO in the State 
where the premises is located requests an in-person audit; and
     For previously infected premises, a biosecurity audit 
shall be conducted in-person by the auditor, unless the auditor 
determines that extenuating circumstances warrant a virtual audit. 
Extenuating circumstances, include, but not limited to, severe adverse 
weather conditions and employee safety considerations.
    Under new Sec.  53.11(f)(2), the producer must allow auditors 
access to their premises (whether virtually or in-person) and access to 
documentation in order for the auditors to complete the biosecurity 
audit using the biosecurity audit tool. If deficiencies are identified, 
the auditors will communicate the identified deficiencies to producers 
and, where appropriate, may work with the producer to identify 
solutions to resolve the deficiencies and may revise the audit results 
based on the additional information provided.
    New Sec.  53.11(f)(3) provides that the reviewer reviews the audit 
package for completeness, accuracy, and consistency with other audits. 
After review, the reviewer will render a final audit determination of 
pass or fail. If requested, the reviewer must be afforded the same 
access to premises previously afforded to the auditor.
    New Sec.  53.11(f)(4) provides a reconsideration process for failed 
outcomes of biosecurity audits. If the producer disagrees with the 
final audit determination of the reviewer, the producer may send a 
written request for reconsideration to the BCAP Program Manager through 
email or by postal mail within 14 calendar days of communication of the 
reviewer's final audit determination. The BCAP Program Manager will 
review the reconsideration request, the audit package prepared by the 
auditor, and the reviewer final audit determination. If the BCAP 
Program Manager determines that the producer wrongfully failed the 
biosecurity audit, he or she will change the final audit determination 
from fail to pass, notify the producer of the change in writing, and 
close the reconsideration request. If the BCAP Program Manager agrees 
that the producer failed the biosecurity audit, the reconsideration 
process will continue to a panel review. A panel consisting of the 
State Animal Health Official, the APHIS Area Veterinarian in Charge, 
and the BCAP 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.
    Under new Sec.  53.11(f)(5), a final audit determination of pass 
for a premises that had a biosecurity audit conducted in accordance 
with Sec.  53.11(f)(1)(i) or (ii) will remain valid for six (6) months 
except for any premises that changes its biosecurity plan, biosecurity 
coordinator, ownership, or infrastructure during that 6-month period. 
If such premises makes any of the aforementioned changes, the premises 
must pass a new biosecurity audit in accordance with Sec.  
53.11(f)(1)(i) or (ii) as applicable, prior to the movement of poultry 
onto the premises.
    APHIS is allowing biosecurity audits of premises in a buffer zone 
to be conducted remotely because, while the premises are at risk of 
becoming affected with HPAI, they are, by definition, currently 
uninfected but in proximity to infected premises, and because premises 
in the buffer zone, as a whole, undergo periodic surveillance. In 
addition, because premises in a buffer zone may have poultry onsite 
during a biosecurity audit, a virtual biosecurity audit prevents the 
introduction of HPAI into the premises. For these reasons, a virtual 
visual inspection (which is conducted using a phone camera, computer, 
or other transmitting device) should usually suffice for the 
biosecurity audit of the premises itself. If a producer is unable to 
participate in a virtual inspection, due to lack of internet or a 
transmitting device, the audit may be conducted in-person. Conversely, 
because previously infected premises have experienced an outbreak of 
HPAI and have the highest risk of reintroduction resulting from 
significant biosecurity lapses, we must verify how well the plan is 
implemented and maintained on-site. In order to ensure that 
reintroduction risks are being effectively mitigated at previously 
infected premises, we are requiring that these biosecurity audits be 
conducted in person, absent extenuating circumstances.
    Revisions to the audit tool are addressed in new Sec.  53.11(f)(6). 
Under the standard process for revisions to the 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. 
Under the immediate process for revisions to the 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 Sec.  53.11(f)(1)(i) or (ii), 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. The primary intent of the preceding revisions 
to part 53 is to enhance effective implementation of and adherence to 
poultry biosecurity plans to mitigate and reduce the introduction, 
reintroduction, and spread of HPAI. Effective implementation of a 
poultry biosecurity plan likely reduces the risk of introduction of 
HPAI onto a premises and mitigates its spread, if introduced. Less risk 
of HPAI introduction and spread would, in turn, reduce the need to 
destroy birds and thus reduce the need of APHIS to make indemnity 
payments. Requirements for biosecurity audits also emphasize and 
validate biosecurity principles that many individual producers are 
already implementing on their premises because of participation in the 
NPIP. Finally, the preceding revisions to part 53 also incentivize 
timely cleanup of HPAI infected premises to mitigate further disease 
spread. Producers are more likely to implement biosecurity measures if 
it will ensure indemnity payments should their premises become infected 
with HPAI, and their birds must be destroyed. Because many of the 
biosecurity principles needed to pass the biosecurity audit are already 
in place, we expect that most producers will not incur large costs from 
this interim rule. We further find that plausible reductions in 
indemnity and virus elimination costs are far higher than costs to 
producers.

[[Page 106992]]

    As of November 2024, APHIS has spent approximately $227 million on 
indemnity payments to premises infected multiple times during the 2022-
2024 outbreak. Epidemiological data attribute most of the source 
introductions in the current outbreak to wild birds, likely due to 
biosecurity gaps. Revising the current regulations to further tie 
indemnity payments to verified implementation of proven biosecurity 
improvements will reduce the occurrence of multiple infections of the 
same premises. Reinfections (like first time infections) result in 
direct economic losses not only from the loss of stock but also from 
downtime to sanitize the premises and to complete other HPAI response 
activities (e.g., the biosecurity audit). This interim rule should 
reduce these losses.
    Since 2012, there have been two (2) major HPAI outbreaks in the 
United States; the first between December 10, 2014, and August 16, 
2015, and the second from February 2, 2022, to present. Aggregating 
price data for broiler meat, turkey meat, and table eggs into two (2) 
groups (prices on those dates during an HPAI outbreak and prices on 
dates that were not in a HPAI outbreak) show that broiler meat, turkey 
meat, and table egg prices are higher during a HPAI outbreak when 
compared to prices during periods of limited HPAI infection.
    APHIS expects this interim rule to result in costs to affected 
producers. Examples of costs include time and labor to implement 
improvements to current biosecurity practices, time to complete and 
pass biosecurity audits, delays to restocking, and costs associated 
with the purchase of or upgrade to equipment needed to conduct a 
virtual audit, if the producer wishes to have a virtual audit. APHIS 
expects the benefits of reduced infections from HPAI will outweigh the 
aforementioned costs associated with this interim rule.
    APHIS estimates that this interim rule will reduce costs to APHIS 
and State partners between $39.56 million and $88.66 million. These 
estimates include reductions in indemnity and response costs less costs 
incurred by APHIS and State partners for buffer zone movement audits 
and previously infected premises audits. APHIS anticipates a slight 
increase in staff time costs that it will incur as a result of 
conducting buffer zone movement audits and previously infected premises 
audits. APHIS expects this interim rule to have costs for producers to 
facilitate the audit (including up-front costs for the purchase of any 
equipment necessary to conduct an audit virtually) and to address any 
resultant biosecurity deficiencies. Producers may also incur additional 
costs if their premises fails an audit and must go through the 
reconsideration process meaning more time will pass before poultry may 
be moved onto the premises or the premises is restocked. Producers in 
infected zones will face costs from delays to restocking based on 
forgone profits. APHIS estimates that these costs will result in $0.49 
to $0.79 million in time, materials, and recordkeeping costs to 
producers. Overall, APHIS estimates that this interim rule will have a 
net benefit of between $38.55 and $87.65 million. In addition to these 
quantified benefits, APHIS also anticipates that this interim rule will 
have small unquantified effects on international trade, consumer 
prices, animal welfare, public health, and producer welfare.

                                          Table 1--Summary of Estimated Costs and Benefits of the Interim Rule
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                            Reduction in costs to APHIS          Cost to producers                 Net benefits
                                                                and State partners       ---------------------------------------------------------------
                                                         --------------------------------
                                                                Low            High             Low            High             Low            High
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                       $, millions
--------------------------------------------------------------------------------------------------------------------------------------------------------
Buffer zone movement audits.............................           15.53           31.23            0.03            0.08           15.45           31.20
Previously infected premises audits.....................           14.63           29.53            0.13            0.18           14.45           29.40
Infected zone waiting period............................            9.40           27.90            0.06            0.26            9.14           27.84
Recordkeeping and paperwork.............................             0.0             0.0            0.27            0.27          (0.27)          (0.27)
                                                         -----------------------------------------------------------------------------------------------
    Total...............................................           39.56           88.66            0.49            0.79           38.55           87.65
--------------------------------------------------------------------------------------------------------------------------------------------------------
Note: Reduction in costs to APHIS and State partners includes estimated reduction in indemnity and response costs less audit costs incurred by APHIS and
  State partners.

    APHIS estimates the total annualized cost of the paperwork and 
recordkeeping associated with this interim rule to be $286,723.13. 
Reporting and recordkeeping requirements associated with this interim 
rule are discussed under the heading ``Paperwork Reduction Act.'' This 
interim rule will mostly affect larger commercial poultry operations 
dealing with HPAI. APHIS estimates that 5.9 percent of all poultry 
operations will be affected by this interim rule although they are 
classified as small by the Small Business Administration.
    The full economic analysis provides a benefit-cost analysis, as 
required by Executive Orders 12866 and 13563, which direct agencies to 
assess all costs and benefits of available regulatory alternatives and, 
if regulation is necessary, to select regulatory approaches that 
maximize net benefits (including potential economic, environmental, 
public health and safety effects, and equity). Executive Order 13563 
emphasizes the importance of quantifying both costs and benefits, of 
reducing costs, of harmonizing rules, and of promoting flexibility. The 
economic analysis also examines the potential economic effects of this 
interim rule on small entities, as required by the Regulatory 
Flexibility Act.

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 rule has been reviewed under Executive Order 12988, Civil 
Justice Reform. This rule (1) preempts all State and local laws and 
regulations that are in conflict with this rule; (2) has no retroactive 
effect; and (3) does not require administrative proceedings before 
parties may file suit in court challenging this rule.

[[Page 106993]]

Executive Order 13175

    This rule has been reviewed in accordance with the requirements of 
Executive Order 13175, Consultation and Coordination With Indian Tribal 
Governments. Executive Order 13175 requires Federal agencies to consult 
and coordinate with Tribes on a government-to-government basis on 
policies that have Tribal implications, including regulations, 
legislative comments or proposed legislation, and other policy 
statements or actions that have substantial direct effects on one or 
more Indian Tribes, on the relationship between the Federal Government 
and Indian Tribes or on the distribution of power and responsibilities 
between the Federal Government and Indian Tribes.
    APHIS has assessed the impact of this interim rule on Indian Tribes 
and determined that this interim rule does not, to our knowledge, have 
Tribal implications that require tribal consultation under Executive 
Order 13175. Additionally, a virtual listening session, ``Tribal 
Listening Session on Highly Pathogenic Avian Influenza Biosecurity 
Compliance Audit Program,'' was held on July 24, 2023, with no Tribes 
in attendance expressing concerns regarding the provisions of the 
interim rule.
    If a Tribe requests consultation, APHIS will work with the Office 
of Tribal Relations to ensure meaningful consultation is provided where 
changes, additions, and modifications identified herein are not 
expressly mandated by Congress.

Paperwork Reduction Act

    In accordance with section 3507(j) of the Paperwork Reduction Act 
of 1995 (44 U.S.C. 3501 et seq.), the information collection and 
recordkeeping requirements included in this interim rule have been 
submitted for emergency approval to the Office of Management and Budget 
(OMB).
    Written comments and recommendations for the proposed information 
collection should be sent within 60 days of publication of this notice 
to www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under 60-day Review--Open for 
Public Comments'' or by using the search function. Please send a copy 
of your comments to: (1) Docket No. APHIS-2023-0088, Regulatory 
Analysis and Development, PPD, APHIS, Station 2C-10.16, 4700 River 
Road, Unit 25, Riverdale, MD 20737-1238, and (2) Clearance Officer, 
OCIO, USDA, Room 404-W, 14th Street and Independence Avenue SW, 
Washington, DC 20250. A comment to OMB is best assured of having its 
full effect if OMB receives it within 30 days of publication of this 
interim rule.
    The U.S. poultry industry is undergoing a severe outbreak of highly 
pathogenic avian influenza (HPAI); it experienced a similar one in 
2015. Pursuant to its existing policy, APHIS is working with State and 
local animal health officials to combat the outbreak, using, in part, 
biosecurity plans and audits consistent with principles outlined in the 
National Poultry Improvement Plan (NPIP). APHIS has denied indemnity 
for poultry operations without biosecurity plans that destroy eggs and 
poultry due to HPAI since 2018 unless the premises is exempted. 
Further, the current paper-based audit process does not always 
illustrate how well the premises is practicing biosecurity to prevent 
HPAI infection or reintroduction. APHIS has found that it often needs 
visual inspection to see how well a premises is carrying out its 
biosecurity plan.
    To help address the spread of HPAI by verifying that commercial 
premises have poultry biosecurity plans with appropriate mitigations 
that are being implemented and maintained, APHIS is amending its 
regulations to require biosecurity audits for two statuses of premises 
as conditions for indemnity for HPAI, and to include procedures for 
reconsideration of audit results. One audit is for HPAI-infected 
premises that intend to restock and wish to be eligible to receive 
subsequent payments of indemnity for poultry destroyed during an 
outbreak. The other is for premises in the buffer zone of a control 
area that intend to move poultry onto a premises within the buffer zone 
and wish to be eligible to receive payments of indemnity for poultry 
that have been moved onto the premises. (The buffer zone is the zone 
within a control area that immediately surrounds an infected zone). 
Premises in the buffer zone are usually notified of this status by the 
State Animal Health Official (SAHO), although within this interim rule 
we are making allowance for notification by APHIS instead.
    APHIS plans to allow virtual biosecurity audits of buffer zone 
premises because, while the premises are at risk of becoming affected 
with HPAI, they are, by definition, currently unaffected. They are in 
proximity to affected premises, however, the premises in the buffer 
zone, as a whole, undergo periodic surveillance. For these reasons, 
virtual visual inspection should usually suffice. Conversely, 
previously affected premises will be audited in person (absent 
extenuating circumstances or a SAHOs request) to ensure that 
reintroduction risks are being effectively mitigated.
    These amendments require the creation of three new information 
collection activities.
    APHIS Biosecurity Audit. Buffer zone poultry premises can be 
audited virtually unless the SAHO in the State where the premises is 
located requests an in-person audit. Previously affected premises will 
be audited in-person, absent extenuating circumstances, unless the SAHO 
requests a virtual audit. All previously infected premises must pass 
additional biosecurity audits every 6 months, until the State in which 
the premises is located declares freedom from HPAI. Producers may use 
successful biosecurity audits completed within the preceding 6 months, 
otherwise a new biosecurity audit must be conducted. If premises in a 
control area change their biosecurity plan, biosecurity coordinator, 
ownership, or infrastructure during the 6-month period, they are 
required to pass a new biosecurity audit in accordance with Sec.  
53.11(f)(1)(i) or (ii) of this interim rule, as applicable, before 
moving poultry onto the premises.
    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. If deficiencies are 
identified, the auditors will communicate the identified deficiencies 
to producers. Producers may ask clarifying questions about the nature 
of the deficiencies and/or provide additional documentation to 
remediate the identified deficiency. The auditor, where appropriate, 
may work with the producer to identify solutions to resolve the 
deficiencies and may revise the audit results based on the additional 
information provided. If the producer needs further guidance on 
addressing a deficiency that goes beyond the auditor's training, the 
auditor will send the request to the audit reviewer and, if needed, the 
BCAP Program Manager. Once the audit process concludes, the auditor 
will submit the audit package to a reviewer based in the State where 
the premises is located.
    Biosecurity Audit Tool. Claims for avian influenza indemnity, 
unless exempted, require producers to have a poultry biosecurity plan 
meeting the biosecurity principles in the NPIP Program Standards. 
Poultry biosecurity plans support continuity of business and are 
specific to the premises and its operational procedures. The NPIP 
Program Standards describe the 14

[[Page 106994]]

biosecurity principles that must be included in the biosecurity plan.
    APHIS developed the Biosecurity Compliance Audit Program (BCAP) to 
administer the audits. The BCAP administration includes a BCAP Program 
Manager within APHIS' Veterinary Services program, and local auditing 
teams comprised of an auditor and reviewer. The BCAP members will use a 
biosecurity audit tool APHIS developed with State and industry input. 
This new biosecurity audit tool includes an evaluation of the premises' 
poultry biosecurity plan against the 14 biosecurity principles 
articulated in the NPIP Program Standards and includes an evaluation of 
the poultry biosecurity plan itself and documentation showing that the 
plan is being implemented. However, the tool also includes visual 
verification of perimeter buffer areas; line of separation procedures 
for personnel, visitors, equipment, and vehicles; and on-premises 
rodent and wildlife mitigations. Use of the tool will ensure 
consistency of reviewing premises and identifying deficiencies in 
biosecurity. The tool may be revised as audits are conducted and 
additional data is gathered, as updated epidemiological information 
becomes available, or as other advancements in technology and 
production practices occur. To that end, the BCAP Program Manager will 
review the tool at least annually. Changes to the tool will appear in a 
notice published in the Federal Register inviting public comment.
    Reconsideration Process for Audit Results. If the producer 
disagrees with the final audit determination of the reviewer, the 
producer may send a request for reconsideration to the BCAP Program 
Manager through email or by postal mail to the addresses listed in the 
regulations. The request for reconsideration must be in writing, state 
the material facts and reasons upon which the producer relies to show 
that the producer wrongfully failed the biosecurity audit, and be 
received by the BCAP Program Manager within 14 calendar days of 
communication of the reviewer's final audit determination. After 
receipt of the reconsideration request, the BCAP Program Manager will 
review the reconsideration request, the audit package prepared by the 
auditor, and the reviewer's final audit determination. If the BCAP 
Program Manager disagrees with the reviewer's final determination the 
results of the biosecurity audit become a pass; if the BCAP Program 
Manager agrees that a biosecurity deficiency exists, the 
reconsideration request proceeds to panel. A panel consisting of the 
SAHO of the State where the premises is located, the APHIS Area 
Veterinarian in Charge, and the BCAP 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 the outcome of the reconsideration process will be communicated to 
the producer, by the auditor, as promptly as circumstances allow and 
will state, in writing, the reasons for the decision.
    We are soliciting comments from the public (as well as affected 
agencies) concerning our information collection and recordkeeping 
requirements. These comments will help us:
    (1) Evaluate whether the 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 
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).
    The Agency estimates there will be 52 State and 473 business 
respondents affected by the three new information collections in this 
interim rule. For the APHIS Biosecurity Audit information collection, 
the Agency estimates there will be 104 State and 473 business 
responses, with 624 total annual burden hours for State respondents and 
total annual 2,728 burden hours for business. For the Biosecurity Audit 
Tool information collection, the Agency estimates there will be 52 
State and 473 business responses, with total burden hours of 208 for 
State respondents and 1,892 for business respondents. For the 
Reconsideration Process for Audit Results information collection, the 
Agency estimates there will be 200 business responses and 200 hours of 
burden annually. Total burden estimates in summary include:
    Estimate of burden: Public reporting burden for this collection of 
information is estimated to average 4 hours per response.
    Respondents: Commercial poultry farm owners and managers; private 
veterinarians; poultry agencies and organizations; and State animal 
health officials and laboratory personnel.
    Estimated annual number of respondents: 525.
    Estimated annual number of responses per respondent: 2.
    Estimated annual number of responses: 1,302.
    Estimated total annual burden on respondents: 5,652 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.) Information about the information collection 
process may be obtained from Mr. Joseph Moxey, APHIS' Paperwork 
Reduction Act Coordinator, at (301) 851-2533. 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. The audit activities and appeals prescribed in this 
information collection must be in writing and may be transmitted by 
email.
    For assistance with E-Government Act compliance related to this 
interim rule, please contact Mr. Joseph Moxey, APHIS' Paperwork 
Reduction Act Coordinator, at (301) 851-2533, or the Veterinary Service 
contact listed above under FOR FURTHER INFORMATION CONTACT.

Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
the Office of Information and Regulatory Affairs determined that this 
rule does not meet the criteria set forth in 5 U.S.C. 804(2).

List of Subjects in 9 CFR Part 53

    Animal diseases, Indemnity payments, Livestock, Poultry and poultry 
products.

    Accordingly, we are amending 9 CFR part 53 as follows:

[[Page 106995]]

PART 53--FOOT-AND-MOUTH DISEASE, PLEUROPNEUMONIA, AND CERTAIN OTHER 
COMMUNICABLE DISEASES OF LIVESTOCK OR POULTRY

0
1. The authority citation for part 53 continues to read as follows:

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

0
2. Amend Sec.  53.1 by adding definitions for ``buffer zone,'' 
``control area,'' and ``infected zone,'' in alphabetical order, to read 
as follows:

Sec.  53.1  Definitions.

* * * * *
    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.
* * * * *
    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.
* * * * *

0
3. Amend Sec.  53.10 by revising paragraph (g) to read as follows:

Sec.  53.10   Claims not allowed.

* * * * *
    (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 
Sec.  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 Sec.  
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 Sec.  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 Sec.  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 
Sec.  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.
* * * * *

0
4. Amend Sec.  53.11 by redesignating paragraph (f) as paragraph (g), 
and adding a new paragraph (f) to read as follows:

Sec.  53.11  Highly pathogenic avian influenza; conditions for payment.

* * * * *
    (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 Sec.  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 Sec.  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

[[Page 106996]]

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.
* * * * *

    Done in Washington, DC, this 23rd day of December 2024.
Jennifer Moffitt,
Undersecretary, Marketing and Regulatory Programs, USDA.
[FR Doc. 2024-31384 Filed 12-30-24; 8:45 am]
BILLING CODE 3410-34-P
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