Rule2024-31384
Payment of Indemnity and Compensation for Highly Pathogenic Avian Influenza
Primary source
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Published
December 31, 2024
Effective
December 31, 2024
Issuing agencies
Agriculture DepartmentAnimal and Plant Health Inspection Service
Abstract
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.
Full Text
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<title>Federal Register, Volume 89 Issue 250 (Tuesday, December 31, 2024)</title>
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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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-31384]
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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:
<bullet> Federal eRulemaking Portal: Go to <a href="http://www.regulations.gov">www.regulations.gov</a>.
Enter APHIS-2023-0088 in the Search field. Select the Documents tab,
then select the Comment button in the list of documents.
<bullet> 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 <a href="http://Regulations.gov">Regulations.gov</a> 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;
<a href="/cdn-cgi/l/email-protection#672b02080906150308491402110e0b0b06271214030649000811"><span class="__cf_email__" data-cfemail="eda18882838c9f8982c39e889b8481818cad989e898cc38a829b">[email protected]</span></a>.
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) (<a href="https://www.aphis.usda.gov/sites/default/files/avian-influenza-case-definition.pdf">https://www.aphis.usda.gov/sites/default/files/avian-influenza-case-definition.pdf</a>). Stakeholders are
notified of HPAI outbreaks through several routes of information; for
example, online announcements are posted on the APHIS website at:
<a href="https://www.aphis.usda.gov/news">https://www.aphis.usda.gov/news</a>. 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:
<a href="https://www.woah.org/fileadmin/Home/eng/Health_standards/tahc/2023/chapitre_avian_influenza_viruses.pdf">https://www.woah.org/fileadmin/Home/eng/Health_standards/tahc/2023/chapitre_avian_influenza_viruses.pdf</a>. For more information on
eradication see <a href="https://www.aphis.usda.gov/sites/default/files/hpai_response_plan.pdf">https://www.aphis.usda.gov/sites/default/files/hpai_response_plan.pdf</a>.
For more information on control area release see <a href="https://www.aphis.usda.gov/sites/default/files/control_area_release.pdf">https://www.aphis.usda.gov/sites/default/files/control_area_release.pdf</a>.
\2\ For more information on reporting outbreaks see WAHIS--
<a href="https://wahis.woah.org/#/home">https://wahis.woah.org/#/home</a>.
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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, (<a href="https://www.aphis.usda.gov/animal_health/emergency_management/downloads/hpai/2015-hpai-final-report.pdf">https://www.aphis.usda.gov/animal_health/emergency_management/downloads/hpai/2015-hpai-final-report.pdf</a>),
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: <a href="https://www.aphis.usda.gov/livestock-poultry-disease/avian/defend-the-flock">https://www.aphis.usda.gov/livestock-poultry-disease/avian/defend-the-flock</a>.
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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 <a href="https://www.aphis.usda.gov/livestock-poultry-disease/avian/defend-the-flock">https://www.aphis.usda.gov/livestock-poultry-disease/avian/defend-the-flock</a>.
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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 <a href="https://www.regulations.gov/docket/APHIS-2015-0061">https://www.regulations.gov/docket/APHIS-2015-0061</a>.
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<bullet> 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
<a href="https://www.poultryimprovement.org">https://www.poultryimprovement.org</a>.
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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;
<bullet> Premises on which fewer than 100,000 broilers are raised
annually; or
<bullet> 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 <a href="https://www.regulations.gov/document/APHIS-2015-0061-0021">https://www.regulations.gov/document/APHIS-2015-0061-0021</a>.
\7\ For more information on the NPIP biennial conference, see
<a href="https://www.poultryimprovement.org/">https://www.poultryimprovement.org/</a>.
\8\ Approved biosecurity principles are listed in the NPIP
Program Standards found here: <a href="https://www.poultryimprovement.org/documents/ProgramStandardsA-E.pdf">https://www.poultryimprovement.org/documents/ProgramStandardsA-E.pdf</a>.
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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 <a href="https://www.aphis.usda.gov/sites/default/files/permitting-live-poultry-infected-zone.pdf">https://www.aphis.usda.gov/sites/default/files/permitting-live-poultry-infected-zone.pdf</a>.
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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 <a href="https://www.aphis.usda.gov/sites/default/files/hpai-2022-2023-summary-depop-analysis.pdf">https://www.aphis.usda.gov/sites/default/files/hpai-2022-2023-summary-depop-analysis.pdf</a>.
\11\ For more information on control area size consideration,
see <a href="https://www.aphis.usda.gov/sites/default/files/hpai_response_plan.pdf">https://www.aphis.usda.gov/sites/default/files/hpai_response_plan.pdf</a>.
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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 <a href="https://www.aphis.usda.gov/sites/default/files/epi-analyses-avian-flu-poultry-2nd-interim-rpt.pdf">https://www.aphis.usda.gov/sites/default/files/epi-analyses-avian-flu-poultry-2nd-interim-rpt.pdf</a>.
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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 <a href="https://www.aphis.usda.gov/sites/default/files/highly-pathogenic-avian-influenza-national-epidemiological-brief-09-24-2024.pdf">https://www.aphis.usda.gov/sites/default/files/highly-pathogenic-avian-influenza-national-epidemiological-brief-09-24-2024.pdf</a>.
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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:
<bullet> Commercial table-egg laying premises with fewer than
75,000 birds;
<bullet> Egg-type game bird and egg-type waterfowl premises with
fewer than 25,000 birds;
<bullet> Premises on which fewer than 100,000 broilers are raised
annually; or
<bullet> 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:
<bullet> 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.
<bullet> 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 (<a href="https://www.aphis.usda.gov/sites/default/files/biosecurityaudit.pdf">https://www.aphis.usda.gov/sites/default/files/biosecurityaudit.pdf</a>), 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 <a href="http://Regulations.gov">Regulations.gov</a>.
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.
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\14\ For more information on the case-control studies, see
<a href="https://www.aphis.usda.gov/sites/default/files/hpai-challenges-implementing-biosecurity.pdf">https://www.aphis.usda.gov/sites/default/files/hpai-challenges-implementing-biosecurity.pdf</a>.
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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 <a href="https://www.aphis.usda.gov/sites/default/files/hpai-dairy-faqs.pdf">https://www.aphis.usda.gov/sites/default/files/hpai-dairy-faqs.pdf</a> and <a href="https://www.aphis.usda.gov/livestock-poultry-disease/avian/avian-influenza/hpai-livestock">https://www.aphis.usda.gov/livestock-poultry-disease/avian/avian-influenza/hpai-livestock</a>.
---------------------------------------------------------------------------
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 <a href="http://Regulations.gov">Regulations.gov</a> website (see ADDRESSES
above for instructions for accessing <a href="http://Regulations.gov">Regulations.gov</a>) 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 <a href="https://www.regulations.gov/docket/APHIS-2015-0061">https://www.regulations.gov/docket/APHIS-2015-0061</a>.
\17\ To access the 2018 final rule, go to <a href="https://www.regulations.gov/docket/APHIS-2015-0061">https://www.regulations.gov/docket/APHIS-2015-0061</a>.
---------------------------------------------------------------------------
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):
<bullet> commercial table-egg-laying premises with fewer than
75,000 birds;
<bullet> egg-type game bird and egg-type waterfowl premises with
fewer than 25,000 birds;
<bullet> premises on which fewer than 100,000 broilers are raised
annually; or
<bullet> 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:
<bullet> 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
<bullet> 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 <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. 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
<a href="http://Regulations.gov">Regulations.gov</a> website or in our reading room. (A link to
<a href="http://Regulations.gov">Regulations.gov</a> 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 <a href="https://www.aphis.usda.gov/sites/default/files/biosecurityaudit.pdf">https://www.aphis.usda.gov/sites/default/files/biosecurityaudit.pdf</a>. 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
<a href="/cdn-cgi/l/email-protection#0544554d4c562b4d55444c2b474644552b6470616c717645707661642b626a73"><span class="__cf_email__" data-cfemail="7736273f3e24593f27363e5935343627591602131e0304370204131659101801">[email protected]</span></a> 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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This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.