Federal Register / Vol. 89, No. 250 / Tuesday, December 31, 2024 / Rules and Regulations 106981 

1Countries declare freedom from HPAI by 

providing evidence demonstrating that the 

requirements for the disease status have been met 

in accordance with WOAH standards found here: 

https://www.woah.org/fileadmin/Home/eng/ 

Health_standards/tahc/2023/chapitre_avian_

influenza_viruses.pdf. For more information on 

eradication see https://www.aphis.usda.gov/sites/ 

default/files/hpai_response_plan.pdf. 

For more information on control area release see 

https://www.aphis.usda.gov/sites/default/files/ 

control_area_release.pdf. 

2For more information on reporting outbreaks see 

WAHIS—https://wahis.woah.org/#/home. 

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. 

SUMMARY: We are amending the 

regulations pertaining to conditions for 

payment of indemnity for highly 

pathogenic avian influenza (HPAI). 

Specifically, we are requiring 

commercial poultry premises to 

successfully pass a biosecurity audit 

prior to restocking if they were 

previously HPAI-infected and wish to 

be eligible for indemnity for the 

restocked poultry. We are also requiring 

a biosecurity audit for commercial 

poultry premises in the buffer zone 

prior to movement of poultry onto the 

premises, if the premises wishes to be 

eligible for indemnity for the poultry 

moved onto the premises. We are also 

revising the regulations to preclude 

indemnity payments for poultry moved 

onto premises in infected zones if the 

poultry become infected with HPAI 

within 14 days following the dissolution 

of the control area in which the infected 

zone is located. This action is necessary 

on an immediate basis in order to 

ensure that commercial poultry 

producers who receive indemnity 

payments for HPAI are taking measures 

to preclude the introduction and spread 

of HPAI, and avoiding actions that 

contribute to its spread. This action 

amends the regulations to condition 

indemnity for HPAI accordingly. 

DATES: This interim rule is effective 

December 31, 2024. We will consider all 

comments that we receive on or before 

March 3, 2025. 

ADDRESSES: You may submit comments 

by either of the following methods: 

• Federal eRulemaking Portal: Go to 

www.regulations.gov. Enter APHIS– 

2023–0088 in the Search field. Select 

the Documents tab, then select the 

Comment button in the list of 

documents. 

• Postal Mail/Commercial Delivery: 

Send your comment to Docket No. 

APHIS–2023–0088, Regulatory Analysis 

and Development, PPD, APHIS, Station 

2C–10.16, 4700 River Road, Unit 25, 

Riverdale, MD 20737–1238. 

Supporting documents and any 

comments we receive on this docket 

may be viewed at Regulations.gov or in 

our reading room, which is located in 

room 1620 of the USDA South Building, 

14th Street and Independence Avenue 

SW, Washington, DC. Normal reading 

room hours are 8 a.m. to 4:30 p.m., 

Monday through Friday, except 

holidays. To be sure someone is there to 

help you, please call (202) 799–7039 

before coming. 

FOR FURTHER INFORMATION CONTACT: Dr. 

Leonardo L. Sevilla, DVM, Veterinary 

Medical Officer, Poultry Health Team, 

VS Strategy and Policy Aquaculture, 

Swine, Equine, and Poultry (ASEP), 

ASEP Health Center, 920 Main Campus 

Drive, Raleigh, NC 27606; (984) 766– 

1528; Leonardo.sevilla@usda.gov. 

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 § 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 § 53.11 provides 

conditions under which payment will 

be made on indemnity claims resulting 

from HPAI outbreaks. 

HPAI Outbreaks and Responses 

HPAI is an extremely infectious and 

fatal form of avian influenza in poultry. 

An HPAI outbreak can have significant 

consequences for the poultry industry, 

wildlife, and producers’ livelihoods, as 

well as significant impacts on 

international trade in poultry and 

poultry products. Certain strains of 

avian influenza have the potential to 

affect humans. An HPAI outbreak in 

poultry in the United States is declared 

when the first case in domestic poultry 

meets the case definition of HPAI as 

defined in USDA APHIS’ National List 

of Reportable Animal Diseases (NLRAD) 

(https://www.aphis.usda.gov/sites/ 

default/files/avian-influenza-casedefinition.pdf). Stakeholders are 

notified of HPAI outbreaks through 

several routes of information; for 

example, online announcements are 

posted on the APHIS website at: https:// 

www.aphis.usda.gov/news. 

Additionally, pursuant to the World 

Organization for Animal Health 

(WOAH) standards,1 at the onset of an 

HPAI outbreak in the United States, 

national level outbreak information is 

posted on the World Animal Health 

Information System.2 The HPAI 

outbreak applies to the entire country, 

and to the State in which the initial 

premises that tested positive is located. 

The outbreak ends in a specific State 

when the State regains freedom from 

HPAI pursuant to the WOAH standards. 

WOAH does not grant official 

recognition of freedom from HPAI in 

poultry. Per WOAH standards, the 

national HPAI outbreak ends when the 

United States declares freedom from 

HPAI in poultry by providing evidence 

demonstrating that the requirements for 

the disease status have been met in 

accordance with WOAH standards. 

Specifically, an outbreak ends when the 

country provides scientific data that 

explains the epidemiology of avian 

influenza in the region concerned and 

also demonstrates how all the risk 

factors are managed. This includes proof 

of effective surveillance strategies that 

mitigate the introduction of HPAI. The 

United States cannot declare freedom 

from HPAI in poultry for the entire 

country if HPAI exists in poultry in any 

State or territory within the country. 

Beginning in December 2014, the U.S. 

poultry industry experienced a severe 

outbreak of HPAI, discovered in 


khammond on DSK9W7S144PROD with RULES
106982 Federal Register / Vol. 89, No. 250 / Tuesday, December 31, 2024 / Rules and Regulations 

3 ‘‘Biosecurity’’ refers to everything people do to 

keep diseases—and the viruses, bacteria, funguses, 

parasites, and other microorganisms that cause 

disease—away from birds, property, and people. 

Biosecurity includes both structural biosecurity and 

operational biosecurity. Structural Biosecurity 

refers to measures used in the physical construction 

and maintenance of coops, pens, poultry houses, 

family farms, commercial farms, and other facilities. 

Operational Biosecurity refers to practices, 

procedures, and policies that people follow 

consistently. For more information see https://

www.aphis.usda.gov/livestock-poultry-disease/ 

avian/defend-the-flock. 

4To view the interim rule, its supporting 

documentation, or the comments that we received, 

go to https://www.regulations.gov/docket/APHIS2015-0061. 

5NPIP is a cooperative Federal-State-industry 

certification program administered by APHIS. For 

more information on NPIP, see https://www.poultry

improvement.org. 

6To access the 2018 final rule, go to https:// 

www.regulations.gov/document/APHIS-2015-0061- 

0021. 

7For more information on the NPIP biennial 

conference, see https://www.poultry

improvement.org/. 

8Approved biosecurity principles are listed in the 

NPIP Program Standards found here: https://

www.poultryimprovement.org/documents/Program

StandardsA-E.pdf. 

backyard flocks in the Pacific 

Northwest, and in two commercial 

turkey and chicken flocks in California. 

APHIS issued a final July 2015 report of 

the 2014–2015 outbreak, (https://

www.aphis.usda.gov/animal_health/ 

emergency_management/downloads/ 

hpai/2015-hpai-final-report.pdf), 

regarding surveillance and other 

response services by APHIS, which has 

been provided to the public. APHIS 

determined that from January 2015 to 

March 2015, the disease spread slowly 

to multiple States, including Minnesota, 

Missouri, Arkansas, and Kansas. In June 

2015, the last case of HPAI was 

confirmed in a commercial flock. 

However, the cost associated with 

response activities was the most 

expensive animal health incident 

recorded in U.S. history. The final cost 

associated with the 2014–2015 outbreak 

was nearly $1 billion. The cost obligated 

for response activities totaled $650 

million and indemnity payments totaled 

$200 million, and an additional $100 

million was made available for further 

preparedness activities. 

The impact of the 2014–2015 HPAI 

outbreak spread beyond financial 

resources and economic concerns. The 

outbreak resulted in regulatory revisions 

to address biosecurity 3 concerns 

identified during the outbreak. In the 

July 2015 report, APHIS determined 

that, amongst other factors, poor 

biosecurity was responsible for the 

introduction of HPAI into some 

commercial poultry facilities. More 

specifically, APHIS stated in the report 

that ‘‘biosecurity measures must be 

improved on premises to not only stop 

HPAI transmission during an outbreak 

but prevent HPAI introductions into 

commercial poultry flocks in the 

future.’’ Biosecurity basics are aimed at 

evaluating a premises for possible 

introduction of disease onto the 

premises, and taking appropriate 

mitigations to address these possible 

sources of introduction and to limit the 

spread of disease, if introduced. Within 

the context of HPAI, these include, but 

are not limited to, the following: (1) 

Keeping visitors on the premises to a 

minimum (HPAI can be transmitted by 

fomites, such as clothing); (2) washing 

hands before coming in contact with 

live poultry (HPAI virus can be 

transmitted by persons coming into 

physical contact with affected poultry); 

(3) cleaning/disinfecting tools or 

equipment before moving them to a new 

poultry facility (HPAI virus can survive 

on the surfaces of farm equipment, 

including tools and means of 

conveyance); and (4) removing wild bird 

nesting and harborage, preventing 

access of wild birds to poultry 

enclosures, and precluding wild birds 

from coming in contact with feed used 

at the premises (as discussed below, 

wild birds can be a significant pathway 

for the spread of HPAI). APHIS poultry 

biosecurity recommendations can be 

found at: https://www.aphis.usda.gov/ 

livestock-poultry-disease/avian/defendthe-flock. 

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: 

• Premises meet the size criteria of 

the National Poultry Improvement Plan 

(NPIP) 5 regulations in that they are 

either: 

Æ Commercial table-egg laying 

premises with fewer than 75,000 birds; 

Æ Egg-type game bird and egg-type 

waterfowl premises with fewer than 

25,000 birds; 

• Premises on which fewer than 

100,000 broilers are raised annually; or 

• Premises on which fewer than 

30,000 meat turkeys are raised annually. 

We took comment on the interim rule 

for 60 days, ending April 11, 2016. In 

response to comments received during 

the comment period, in a final rule 

published in the Federal Register on 

August 15, 2018 (83 FR 40433–40438, 

Docket No. APHIS–2015–0061),6 we 

amended § 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. 

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 


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9For more information on APHIS’ HPAI response, 

see https://www.aphis.usda.gov/sites/default/files/ 

permitting-live-poultry-infected-zone.pdf. 

10For HPAI Depopulation Analysis Report, see 

https://www.aphis.usda.gov/sites/default/files/ 

hpai-2022-2023-summary-depop-analysis.pdf. 

11For more information on control area size 

consideration, see https://www.aphis.usda.gov/ 

sites/default/files/hpai_response_plan.pdf. 

12For report of epidemiologic and other analysis 

of HPAI affected poultry, see https://

www.aphis.usda.gov/sites/default/files/epianalyses-avian-flu-poultry-2nd-interim-rpt.pdf. 

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. 

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. 

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. 

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 noncommercial 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 


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106984 Federal Register / Vol. 89, No. 250 / Tuesday, December 31, 2024 / Rules and Regulations 

13For more information on transmission, see 

https://www.aphis.usda.gov/sites/default/files/ 

highly-pathogenic-avian-influenza-nationalepidemiological-brief-09-24-2024.pdf. 

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

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 § 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 § 53.11 to set 

forth the process for conducting the 

biosecurity audits required by § 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 

§ 53.1 to add definitions for the terms 

‘‘buffer zone,’’, ‘‘control area,’’ and 

‘‘infected zone,’’ which are used in 

amended § 53.10 and/or § 53.11. 

The specific nature of the revisions is 

discussed immediately below. 


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Revisions to § 53.10 and § 53.1 

As we noted above, § 53.10 of the 

regulations provides conditions under 

which indemnity claims are not 

allowed. We are only proposing changes 

to § 53.10(g). 

We are proposing some minor 

changes to § 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 

§ 53.10(g)(1). Revised § 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 § 53.10(g)(1)(i). 

We are also revising § 53.10(g) to 

provide several additional conditions 

under which indemnity claims are not 

allowed. Under new § 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 § 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 

§ 53.11(f)(1)(i) if the poultry are placed 

irrespective of the Administrator’s 

determination. 

Additionally, under new 

§ 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 

§ 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 § 53.10(g)(1)(ii) 

to request a post-placement audit from 

the Administrator (if the shipment 

cannot be delayed). All previously 

infected premises in a State must pass 

virtual biosecurity audits every six (6) 

months until the State in which the 

premises is located declares freedom 

from HPAI. The additional audits are 

based on APHIS’ review of 

chronological outbreak data regarding 

date of all case detections relative to 

virus elimination and audit dates for 

known infected poultry premises. The 

data analysis indicated that previously 

infected premises that had biosecurity 

audits conducted on a voluntary basis 

did not have any HPAI introduction 

within 180 days post-audit and 

movement of poultry. Based on this 

data, APHIS found that the risk of HPAI 

reintroduction on a previously infected 

premises is low within 6 months. 

Additionally, the 180 days roughly 

aligns with wild bird migratory patterns, 

when increased risk of introduction 

from wild birds is elevated, and it 

would be appropriate to ensure poultry 

premises are implementing heightened 

biosecurity practices. 

As stated previously, the regulations 

currently exempt producers from having 

to develop and follow a poultry 

biosecurity plan as a condition of 

indemnity for HPAI if any of the 

following apply: 

• Commercial table-egg laying 

premises with fewer than 75,000 birds; 

• Egg-type game bird and egg-type 

waterfowl premises with fewer than 

25,000 birds; 

• Premises on which fewer than 

100,000 broilers are raised annually; or 

• Premises on which fewer than 

30,000 meat turkeys are raised annually. 

Because these premises are not 

currently required to develop and 

follow a poultry biosecurity plan, we are 

also exempting them from being 

required to pass a biosecurity audit. As 

we noted in the 2016 interim rule, more 

than 97 percent of turkeys and 99 

percent of broilers are raised on farms 

that are above these size thresholds. 

Additionally, whereas the regulations 

had previously cited the relevant 

provisions of the NPIP regulations for 

the first two size standards, to aid in 

readability of the section, we are 

removing the reference to the NPIP 

regulations and, in their place, adding 

the actual size standards that are being 

referenced. We are not changing the size 

standards themselves, simply restating 

them within § 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 § 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 


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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 § 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 § 53.11 

Section 53.11 provides conditions 

under which payment will be made on 

indemnity claims resulting from HPAI 

outbreaks. We are amending § 53.11 to 

describe how the biosecurity audits, 

required by the revisions to § 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 § 53.11 

provides that APHIS requires a 

biosecurity audit to be conducted on the 

following poultry premises: 

• For premises in a buffer zone, a 

biosecurity audit shall be conducted 

virtually by the auditor, unless the 

SAHO in the State where the premises 

is located requests an in-person audit. 

For example, if the facility lacks 

necessary equipment or IT 

infrastructure on the premises to 

conduct a virtual audit, a SAHO could 

request an in-person audit. 

• For previously infected premises, a 

biosecurity audit shall be conducted inperson 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 inperson 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 EarthTM 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 


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a limited view may not disclose all 

possible risks of reintroduction of HPAI 

to the premises, and require an inperson audit for better visual and 

auditory context, absent extenuating 

circumstances. To provide two 

examples that underscore the 

importance of in-person audits for 

visual and auditory context, a 

component of the audit involves 

evaluating whether feed and bedding at 

the facility may have been contaminated 

by exposure to rodents. Evidence (visual 

or auditory) of previous or current 

rodent infestation at the premises may 

be much easier to identify in person 

than virtually. Another component 

requires the inspector to inspect and/or 

monitor the enclosed structures housing 

live poultry to ensure sound 

construction and that they are kept in 

good repair. An in-person auditor may 

hear air circulation suggesting a hole or 

breach in the facility that would not 

necessarily be easy to detect through a 

virtual audit. 

To implement these two biosecurity 

audit processes within the Agency, 

APHIS developed the Biosecurity 

Compliance Audit Program (BCAP), 

which includes a BCAP Program 

Manager within APHIS’ Veterinary 

Services program, and an auditing team 

comprised of an auditor and a reviewer. 

The auditor makes the initial 

determination of whether a premises 

passes a biosecurity audit. Generally, 

APHIS expects the auditor role will be 

filled by a State employee. However, if 

a State lacks the human resources to fill 

the position, an APHIS employee can 

fill the role. Conversely, the reviewer 

makes the final determination of 

whether a premises passes a biosecurity 

audit. This position will always be an 

APHIS employee because a final audit 

determination is an Agency decision 

that affects the eligibility of the 

producer to receive future indemnity 

payments for poultry destroyed due to 

HPAI. All biosecurity auditors and audit 

reviewers will undergo a USDA-led 

training program prior to being added to 

a team. The training includes ensuring 

consistent application of the biosecurity 

audit tool, awareness of different 

poultry production types and farm 

layouts, and different methods and 

technologies for implementation of 

biosecurity. 

During biosecurity audits, the audit 

team will conduct the audits using a 

biosecurity audit tool (https://

www.aphis.usda.gov/sites/default/files/ 

biosecurityaudit.pdf), developed by 

APHIS with State and industry input. 

From January 2024 through May 2024, 

industry provided APHIS with oral and 

written feedback regarding the 

operational feasibility of implementing 

on an ongoing basis a biosecurity audit 

checklist in use provisionally for 

poultry biosecurity audits conducted 

since the start of the current outbreak. 

The tool includes aspects of the current 

paper-based biosecurity audit that is 

conducted by OSA’s on at least a 

biennial basis. In addition, the 

biosecurity tool was built upon the NPIP 

biosecurity criteria and the HPAI 

Control Area Placement Biosecurity 

Audit Checklist that was developed in 

2022. As stated previously, as part of the 

biennial biosecurity audit, the OSA will, 

at a minimum, evaluate the poultry 

biosecurity plan itself, which includes 

an evaluation of the poultry biosecurity 

plan, against 14 biosecurity principles 

articulated in the NPIP Program 

Standards policy document, and review 

the documentation showing that the 

poultry biosecurity plan is being 

implemented. A member of the audit 

team will conduct this review as well. 

The audit tool also includes visual 

verification of perimeter buffer areas; 

line-of-separation (LOS) procedures for 

personnel, visitors, equipment, and 

vehicles; and on-premises rodent and 

wildlife mitigations, some of the 14 

NPIP biosecurity principles. Use of the 

audit tool will ensure that audit teams 

consistently review premises and 

identify deficiencies in biosecurity. 

APHIS is making a copy of the tool 

available as a supporting document for 

this interim rule on Regulations.gov. 

Revisions to the audit tool are 

addressed in new § 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 

§ 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 § 53.11(f)(2), the producer 

must allow auditors access to their 

premises (whether virtually or inperson) 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 § 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 

§ 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 § 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 


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14For more information on the case-control 

studies, see https://www.aphis.usda.gov/sites/ 

default/files/hpai-challenges-implementingbiosecurity.pdf. 

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 

§ 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 § 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. 

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 


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Federal Register / Vol. 89, No. 250 / Tuesday, December 31, 2024 / Rules and Regulations 106989 

15For more information on the phylogenetic and 

epidemiological data, see https://

www.aphis.usda.gov/sites/default/files/hpai-dairyfaqs.pdf and https://www.aphis.usda.gov/livestockpoultry-disease/avian/avian-influenza/hpailivestock. 

16To view the interim rule, its supporting 

documentation, or the comments that we received, 

go to https://www.regulations.gov/docket/APHIS2015-0061. 

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. 

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 costbenefit analysis, as required by 

Executive Orders 12866 and 13563, 

which direct agencies to assess all costs 

and benefits of available regulatory 

alternatives and, if regulation is 

necessary, to select regulatory 

approaches that maximize net benefits 

(including potential economic, 

environmental, public health and safety 

effects, and equity). Executive Order 

13563 emphasizes the importance of 

quantifying both costs and benefits, of 

reducing costs, of harmonizing rules, 

and of promoting flexibility. The 

economic analysis also examines the 

potential economic effects of this 

interim rule on small entities, as 

required by the Regulatory Flexibility 

Act. The economic analysis is 

summarized below. The full analysis 

may be viewed on the Regulations.gov 

website (see ADDRESSES above for 

instructions for accessing 

Regulations.gov) or obtained from the 

person listed under FOR FURTHER

INFORMATION CONTACT. 

APHIS is establishing requirements 

for certain poultry premises to complete 

a biosecurity audit as a condition for 

receiving indemnity payments for 

poultry depopulated because of an 

outbreak of HPAI. APHIS’ response to 

HPAI via regulation is not new. In 2016, 

APHIS published an interim rule (81 FR 

6745–6751, Docket No. APHIS–2015– 

0061) 16 that amended § 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 § 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 


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106990 Federal Register / Vol. 89, No. 250 / Tuesday, December 31, 2024 / Rules and Regulations 

17To access the 2018 final rule, go to https://

www.regulations.gov/docket/APHIS-2015-0061. 

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. 

This interim rule amends § 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 § 53.10(g) exempts producers 

from having to develop and follow a 

poultry biosecurity plan as a condition 

of indemnity for HPAI if any of the 

following apply: 

The producer is a(n): 

• commercial table-egg-laying 

premises with fewer than 75,000 birds; 

• egg-type game bird and egg-type 

waterfowl premises with fewer than 

25,000 birds; 

• premises on which fewer than 

100,000 broilers are raised annually; or 

• premises on which fewer than 

30,000 meat turkeys are raised annually. 

Because these premises are not 

currently required to develop and 

follow a poultry biosecurity plan, in this 

interim rule, we are also exempting 

them from being required to pass a 

biosecurity audit. More than 97 percent 

of turkeys and 99 percent of broilers are 

raised on farms that exceed these size 

thresholds. However, flock size is nonsignificantly 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 

§ 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 § 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 § 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 § 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 § 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 

§ 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 

§ 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 § 53.11 to set forth the 

process for conducting the biosecurity 

audits required by § 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 


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Federal Register / Vol. 89, No. 250 / Tuesday, December 31, 2024 / Rules and Regulations 106991 

biosecurity audit shall be conducted inperson 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 § 53.11(f)(1), APHIS 

requires biosecurity audits to be 

conducted as follows: 

• For premises in a buffer zone, a 

biosecurity audit shall be conducted 

virtually by the auditor, unless the 

SAHO in the State where the premises 

is located requests an in-person audit; 

and 

• For previously infected premises, a 

biosecurity audit shall be conducted inperson 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 § 53.11(f)(2), the producer 

must allow auditors access to their 

premises (whether virtually or inperson) 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 § 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 § 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 § 53.11(f)(5), a final audit 

determination of pass for a premises 

that had a biosecurity audit conducted 

in accordance with § 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 § 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 § 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 

§ 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. 


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106992 Federal Register / Vol. 89, No. 250 / Tuesday, December 31, 2024 / Rules and Regulations 

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 

and State partners 

Cost to producers Net benefits 

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. 


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Federal Register / Vol. 89, No. 250 / Tuesday, December 31, 2024 / Rules and Regulations 106993 

Executive Order 13175 

This rule has been reviewed in 

accordance with the requirements of 

Executive Order 13175, Consultation 

and Coordination With Indian Tribal 

Governments. Executive Order 13175 

requires Federal agencies to consult and 

coordinate with Tribes on a 

government-to-government basis on 

policies that have Tribal implications, 

including regulations, legislative 

comments or proposed legislation, and 

other policy statements or actions that 

have substantial direct effects on one or 

more Indian Tribes, on the relationship 

between the Federal Government and 

Indian Tribes or on the distribution of 

power and responsibilities between the 

Federal Government and Indian Tribes. 

APHIS has assessed the impact of this 

interim rule on Indian Tribes and 

determined that this interim rule does 

not, to our knowledge, have Tribal 

implications that require tribal 

consultation under Executive Order 

13175. Additionally, a virtual listening 

session, ‘‘Tribal Listening Session on 

Highly Pathogenic Avian Influenza 

Biosecurity Compliance Audit 

Program,’’ was held on July 24, 2023, 

with no Tribes in attendance expressing 

concerns regarding the provisions of the 

interim rule. 

If a Tribe requests consultation, 

APHIS will work with the Office of 

Tribal Relations to ensure meaningful 

consultation is provided where changes, 

additions, and modifications identified 

herein are not expressly mandated by 

Congress. 

Paperwork Reduction Act 

In accordance with section 3507(j) of 

the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501 et seq.), the information 

collection and recordkeeping 

requirements included in this interim 

rule have been submitted for emergency 

approval to the Office of Management 

and Budget (OMB). 

Written comments and 

recommendations for the proposed 

information collection should be sent 

within 60 days of publication of this 

notice to www.reginfo.gov/public/do/ 

PRAMain. Find this particular 

information collection by selecting 

‘‘Currently under 60-day Review—Open 

for Public Comments’’ or by using the 

search function. Please send a copy of 

your comments to: (1) Docket No. 

APHIS–2023–0088, Regulatory Analysis 

and Development, PPD, APHIS, Station 

2C–10.16, 4700 River Road, Unit 25, 

Riverdale, MD 20737–1238, and (2) 

Clearance Officer, OCIO, USDA, Room 

404–W, 14th Street and Independence 

Avenue SW, Washington, DC 20250. A 

comment to OMB is best assured of 

having its full effect if OMB receives it 

within 30 days of publication of this 

interim rule. 

The U.S. poultry industry is 

undergoing a severe outbreak of highly 

pathogenic avian influenza (HPAI); it 

experienced a similar one in 2015. 

Pursuant to its existing policy, APHIS is 

working with State and local animal 

health officials to combat the outbreak, 

using, in part, biosecurity plans and 

audits consistent with principles 

outlined in the National Poultry 

Improvement Plan (NPIP). APHIS has 

denied indemnity for poultry operations 

without biosecurity plans that destroy 

eggs and poultry due to HPAI since 

2018 unless the premises is exempted. 

Further, the current paper-based audit 

process does not always illustrate how 

well the premises is practicing 

biosecurity to prevent HPAI infection or 

reintroduction. APHIS has found that it 

often needs visual inspection to see how 

well a premises is carrying out its 

biosecurity plan. 

To help address the spread of HPAI 

by verifying that commercial premises 

have poultry biosecurity plans with 

appropriate mitigations that are being 

implemented and maintained, APHIS is 

amending its regulations to require 

biosecurity audits for two statuses of 

premises as conditions for indemnity for 

HPAI, and to include procedures for 

reconsideration of audit results. One 

audit is for HPAI-infected premises that 

intend to restock and wish to be eligible 

to receive subsequent payments of 

indemnity for poultry destroyed during 

an outbreak. The other is for premises 

in the buffer zone of a control area that 

intend to move poultry onto a premises 

within the buffer zone and wish to be 

eligible to receive payments of 

indemnity for poultry that have been 

moved onto the premises. (The buffer 

zone is the zone within a control area 

that immediately surrounds an infected 

zone). Premises in the buffer zone are 

usually notified of this status by the 

State Animal Health Official (SAHO), 

although within this interim rule we are 

making allowance for notification by 

APHIS instead. 

APHIS plans to allow virtual 

biosecurity audits of buffer zone 

premises because, while the premises 

are at risk of becoming affected with 

HPAI, they are, by definition, currently 

unaffected. They are in proximity to 

affected premises, however, the 

premises in the buffer zone, as a whole, 

undergo periodic surveillance. For these 

reasons, virtual visual inspection should 

usually suffice. Conversely, previously 

affected premises will be audited in 

person (absent extenuating 

circumstances or a SAHOs request) to 

ensure that reintroduction risks are 

being effectively mitigated. 

These amendments require the 

creation of three new information 

collection activities. 

APHIS Biosecurity Audit. Buffer zone 

poultry premises can be audited 

virtually unless the SAHO in the State 

where the premises is located requests 

an in-person audit. Previously affected 

premises will be audited in-person, 

absent extenuating circumstances, 

unless the SAHO requests a virtual 

audit. All previously infected premises 

must pass additional biosecurity audits 

every 6 months, until the State in which 

the premises is located declares freedom 

from HPAI. Producers may use 

successful biosecurity audits completed 

within the preceding 6 months, 

otherwise a new biosecurity audit must 

be conducted. If premises in a control 

area change their biosecurity plan, 

biosecurity coordinator, ownership, or 

infrastructure during the 6-month 

period, they are required to pass a new 

biosecurity audit in accordance with 

§ 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 


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106994 Federal Register / Vol. 89, No. 250 / Tuesday, December 31, 2024 / Rules and Regulations 

biosecurity principles that must be 

included in the biosecurity plan. 

APHIS developed the Biosecurity 

Compliance Audit Program (BCAP) to 

administer the audits. The BCAP 

administration includes a BCAP 

Program Manager within APHIS’ 

Veterinary Services program, and local 

auditing teams comprised of an auditor 

and reviewer. The BCAP members will 

use a biosecurity audit tool APHIS 

developed with State and industry 

input. This new biosecurity audit tool 

includes an evaluation of the premises’ 

poultry biosecurity plan against the 14 

biosecurity principles articulated in the 

NPIP Program Standards and includes 

an evaluation of the poultry biosecurity 

plan itself and documentation showing 

that the plan is being implemented. 

However, the tool also includes visual 

verification of perimeter buffer areas; 

line of separation procedures for 

personnel, visitors, equipment, and 

vehicles; and on-premises rodent and 

wildlife mitigations. Use of the tool will 

ensure consistency of reviewing 

premises and identifying deficiencies in 

biosecurity. The tool may be revised as 

audits are conducted and additional 

data is gathered, as updated 

epidemiological information becomes 

available, or as other advancements in 

technology and production practices 

occur. To that end, the BCAP Program 

Manager will review the tool at least 

annually. Changes to the tool will 

appear in a notice published in the 

Federal Register inviting public 

comment. 

Reconsideration Process for Audit 

Results. If the producer disagrees with 

the final audit determination of the 

reviewer, the producer may send a 

request for reconsideration to the BCAP 

Program Manager through email or by 

postal mail to the addresses listed in the 

regulations. The request for 

reconsideration must be in writing, state 

the material facts and reasons upon 

which the producer relies to show that 

the producer wrongfully failed the 

biosecurity audit, and be received by the 

BCAP Program Manager within 14 

calendar days of communication of the 

reviewer’s final audit determination. 

After receipt of the reconsideration 

request, the BCAP Program Manager 

will review the reconsideration request, 

the audit package prepared by the 

auditor, and the reviewer’s final audit 

determination. If the BCAP Program 

Manager disagrees with the reviewer’s 

final determination the results of the 

biosecurity audit become a pass; if the 

BCAP Program Manager agrees that a 

biosecurity deficiency exists, the 

reconsideration request proceeds to 

panel. A panel consisting of the SAHO 

of the State where the premises is 

located, the APHIS Area Veterinarian in 

Charge, and the BCAP Program Manager 

will review the reconsideration request, 

the audit package prepared by the 

auditor, and the reviewer’s final audit 

determination. The panel’s decision is 

final and the outcome of the 

reconsideration process will be 

communicated to the producer, by the 

auditor, as promptly as circumstances 

allow and will state, in writing, the 

reasons for the decision. 

We are soliciting comments from the 

public (as well as affected agencies) 

concerning our information collection 

and recordkeeping requirements. These 

comments will help us: 

(1) Evaluate whether the information 

collection is necessary for the proper 

performance of our agency’s functions, 

including whether the information will 

have practical utility; 

(2) Evaluate the accuracy of our 

estimate of the burden of the 

information collection, including the 

validity of the methodology and 

assumptions used; 

(3) Enhance the quality, utility, and 

clarity of the information to be 

collected; and 

(4) Minimize the burden of the 

information collection on those who are 

to respond (such as through the use of 

appropriate automated, electronic, 

mechanical, or other technological 

collection techniques or other forms of 

information technology; e.g., permitting 

electronic submission of responses). 

The Agency estimates there will be 52 

State and 473 business respondents 

affected by the three new information 

collections in this interim rule. For the 

APHIS Biosecurity Audit information 

collection, the Agency estimates there 

will be 104 State and 473 business 

responses, with 624 total annual burden 

hours for State respondents and total 

annual 2,728 burden hours for business. 

For the Biosecurity Audit Tool 

information collection, the Agency 

estimates there will be 52 State and 473 

business responses, with total burden 

hours of 208 for State respondents and 

1,892 for business respondents. For the 

Reconsideration Process for Audit 

Results information collection, the 

Agency estimates there will be 200 

business responses and 200 hours of 

burden annually. Total burden estimates 

in summary include: 

Estimate of burden: Public reporting 

burden for this collection of information 

is estimated to average 4 hours per 

response. 

Respondents: Commercial poultry 

farm owners and managers; private 

veterinarians; poultry agencies and 

organizations; and State animal health 

officials and laboratory personnel. 

Estimated annual number of 

respondents: 525. 

Estimated annual number of 

responses per respondent: 2. 

Estimated annual number of 

responses: 1,302. 

Estimated total annual burden on 

respondents: 5,652 hours. (Due to 

averaging, the total annual burden hours 

may not equal the product of the annual 

number of responses multiplied by the 

reporting burden per response.) 

A copy of the information collection 

may be viewed on the Regulations.gov 

website or in our reading room. (A link 

to Regulations.gov and information on 

the location and hours of the reading 

room are provided under the heading 

ADDRESSES at the beginning of this 

proposed rule.) Information about the 

information collection process may be 

obtained from Mr. Joseph Moxey, 

APHIS’ Paperwork Reduction Act 

Coordinator, at (301) 851–2533. APHIS 

will respond to any ICR-related 

comments in the final rule. All 

comments will also become a matter of 

public record. 

E-Government Act Compliance 

The Animal and Plant Health 

Inspection Service is committed to 

compliance with the E-Government Act 

to promote the use of the internet and 

other information technologies, to 

provide increased opportunities for 

citizen access to Government 

information and services, and for other 

purposes. The audit activities and 

appeals prescribed in this information 

collection must be in writing and may 

be transmitted by email. 

For assistance with E-Government Act 

compliance related to this interim rule, 

please contact Mr. Joseph Moxey, 

APHIS’ Paperwork Reduction Act 

Coordinator, at (301) 851–2533, or the 

Veterinary Service contact listed above 

under FOR FURTHER INFORMATION

CONTACT. 

Congressional Review Act 

Pursuant to the Congressional Review 

Act (5 U.S.C. 801 et seq.), the Office of 

Information and Regulatory Affairs 

determined that this rule does not meet 

the criteria set forth in 5 U.S.C. 804(2). 

List of Subjects in 9 CFR Part 53 

Animal diseases, Indemnity 

payments, Livestock, Poultry and 

poultry products. 

Accordingly, we are amending 9 CFR 

part 53 as follows: 


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Federal Register / Vol. 89, No. 250 / Tuesday, December 31, 2024 / Rules and Regulations 106995 

PART 53—FOOT-AND-MOUTH 

DISEASE, PLEUROPNEUMONIA, AND 

CERTAIN OTHER COMMUNICABLE 

DISEASES OF LIVESTOCK OR 

POULTRY 

■ 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. 

■ 2. Amend § 53.1 by adding definitions 

for ‘‘buffer zone,’’ ‘‘control area,’’ and 

‘‘infected zone,’’ in alphabetical order, 

to read as follows: 

§ 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. 

* * * * * 

■ 3. Amend § 53.10 by revising 

paragraph (g) to read as follows: 

§ 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 § 53.11(e). 

(ii) Buffer zone movement audit: For 

indemnity claims for poultry moved 

onto a premises located in a buffer zone 

of a control area for highly pathogenic 

avian influenza, the premises receiving 

the poultry must pass a biosecurity 

audit conducted in accordance with 

§ 53.11(f)(1)(i) prior to the movement of 

poultry onto the premises; unless the 

premises receiving the poultry passed a 

biosecurity audit within the preceding 

six (6) months. Provided, that the 

Administrator may, upon request by a 

producer and upon his or her 

determination that such action will not 

result in the dissemination of highly 

pathogenic avian influenza within the 

United States, allow a premises to pass 

a biosecurity audit in accordance with 

§ 53.11(f)(1)(i) after the placement of 

poultry onto the premises. The producer 

must make such a request in writing and 

state in the request all the facts and 

reasons justifying the request. If the 

request is denied, the premises must 

pass a biosecurity audit in accordance 

with § 53.11(f)(1)(i) prior to the 

placement of poultry onto the premises 

to be eligible to receive future 

indemnity payment if the poultry is 

later infected with highly pathogenic 

avian influenza. 

(iii) Previously infected premises 

audit: For indemnity claims for poultry 

moved onto any premises that was 

previously infected with highly 

pathogenic avian influenza during the 

same outbreak, the premises must pass 

a biosecurity audit conducted in 

accordance with § 53.11(f)(1)(ii) prior to 

the movement of poultry onto the 

premises; unless the movement occurs 

after the United States declares freedom 

from highly pathogenic avian influenza. 

In addition, all previously infected 

premises must pass virtually conducted 

biosecurity audits every six (6) months 

until the State in which the premises is 

located declares freedom from highly 

pathogenic avian influenza. 

(2) Owners and contractors are 

exempted from the requirements of 

paragraph (g)(1) of this section if the 

facilities where the poultry or eggs are 

raised or cared for falls under one of the 

following categories: 

(i) Commercial table-egg laying 

premises with fewer than 75,000 birds; 

(ii) Egg-type game bird and egg-type 

waterfowl premises with fewer than 

25,000 birds. 

(iii) Premises on which fewer than 

100,000 broilers are raised annually; 

and 

(iv) Premises on which fewer than 

30,000 meat turkeys are raised annually. 

(3) Notwithstanding the conditions in 

paragraphs (g)(1) and (2) of this section, 

the Department will not pay claims 

arising out of the destruction of poultry 

destroyed due to an outbreak of highly 

pathogenic avian influenza if the 

poultry was moved onto a premises in 

an infected zone and if the poultry 

becomes infected with HPAI within 14 

days following the dissolution of the 

control area in which the infected zone 

is located. 

* * * * * 

■ 4. Amend § 53.11 by redesignating 

paragraph (f) as paragraph (g), and 

adding a new paragraph (f) to read as 

follows: 

§ 53.11 Highly pathogenic avian influenza; 

conditions for payment. 

* * * * * 

(f)(1) The Department requires that a 

biosecurity audit be conducted by an 

auditing team comprised of an auditor 

and a reviewer using the biosecurity 

audit tool available at https://

www.aphis.usda.gov/sites/default/files/ 

biosecurityaudit.pdf. The auditor makes 

the initial determination of whether a 

premises passes a biosecurity audit and 

will be a State employee. If the State 

lacks the human resources to fill the 

position, an APHIS employee can fill 

the position. The reviewer makes the 

final determination of whether a 

premises passes a biosecurity audit and 

will be an APHIS employee. The audit 

will be conducted as follows: 

(i) Biosecurity audits for premises in 

a buffer zone as described in 

§ 53.10(g)(1)(ii), shall be conducted 

virtually by an auditor unless the State 

Animal Health Official, in the State 

where the premises is located, requests 

an in-person audit. 

(ii) Biosecurity audits for previously 

infected premises as described in 

§ 53.10(g)(1)(iii), shall be conducted inperson 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 


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106996 Federal Register / Vol. 89, No. 250 / Tuesday, December 31, 2024 / Rules and Regulations 

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 APHIS.HPAI.BCAP.audits@usda.gov 

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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 101 

[Docket No. FDA–2000–N–0011] 

Uniform Compliance Date for Food 

Labeling Regulations 

AGENCY: Food and Drug Administration, 

Department of Health and Human 

Services (HHS). 

ACTION: Final action; announcement of a 

uniform compliance date. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

establishing January 1, 2028, as the 

uniform compliance date for food 

labeling regulations that are published 

on or after January 1, 2025, and on or 

before December 31, 2026. We 

periodically announce uniform 

compliance dates for new food labeling 

requirements to minimize the economic 

impact of labeling changes. 

DATES: This final action is effective 

December 31, 2024. Either electronic or 

written comments on the final action 

must be submitted by March 3, 2025. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. The https://

www.regulations.gov electronic filing 

system will accept comments until 

11:59 p.m. Eastern Time at the end of 

March 3, 2025. Comments received by 

mail/hand delivery/courier (for written/ 

paper submissions) will be considered 

timely if they are received on or before 

that date. 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand Delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 


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