Low Pathogenic Avian Influenza; Voluntary Control Program and Payment of Indemnity, 10645-10658 [2010-4874]
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Federal Register / Vol. 75, No. 45 / Tuesday, March 9, 2010 / Rules and Regulations
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
9 CFR Parts 53, 56, 145, 146, and 147
[Docket No. APHIS-2005-0109]
RIN 0579-AB99
Low Pathogenic Avian Influenza;
Voluntary Control Program and
Payment of Indemnity
AGENCY: Animal and Plant Health
Inspection Service, USDA.
ACTION: Final rule.
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SUMMARY: We are adopting as a final
rule, with changes, an interim rule that
amended the regulations by
establishing, under the auspices of the
National Poultry Improvement Plan, a
voluntary program for the control of the
H5/H7 subtypes of low pathogenic avian
influenza in commercial poultry. As
amended by this document, the rule
provides that the amount of indemnity
for which contract growers are eligible
will be reduced by any payment they
have already received on their contracts
when poultry in their care are
destroyed, clarifies the roles of
cooperating State agencies with respect
to H5/H7 low pathogenic avian
influenza outbreaks, provides that
consistency with humane euthanasia
guidelines will be considered when
selecting a method for the destruction of
poultry, and provides additional
guidance for cleaning and disinfecting
an affected premises. The control
program and indemnity provisions
established by the interim rule are
necessary to help ensure that the H5/H7
subtypes of low pathogenic avian
influenza are detected and eradicated
when they occur within the United
States.
EFFECTIVE DATE: March 9, 2010.
FOR FURTHER INFORMATION CONTACT: Mr.
Andrew R. Rhorer, Senior Coordinator,
Poultry Improvement Staff, National
Poultry Improvement Plan, Veterinary
Services, APHIS, USDA, 1498 Klondike
Road, Suite 101, Conyers, GA 300945104; (770) 922-3496.
SUPPLEMENTARY INFORMATION:
Background
The National Poultry Improvement
Plan (NPIP, also referred to below as
‘‘the Plan’’) is a cooperative FederalState-industry mechanism for
controlling certain poultry diseases. The
Plan consists of a variety of programs
intended to prevent and control poultry
diseases. Participation in all Plan
programs is voluntary, but breeding
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flocks, hatcheries, and dealers must first
qualify as ‘‘U.S. Pullorum-Typhoid
Clean’’ as a condition for participating in
the other Plan programs.
The Plan identifies States, flocks,
hatcheries, dealers, and slaughter plants
that meet certain disease control
standards specified in the Plan’s various
programs. As a result, customers can
buy poultry that has tested clean of
certain diseases or that has been
produced under disease-prevention
conditions. The regulations in 9 CFR
parts 145, 146, and 147 (referred to
below as the regulations) contain the
provisions of the Plan.
In an interim rule1 effective and
published in the Federal Register on
September 26, 2006 (71 FR 5360156333, Docket No. APHIS-2005-0109),
we amended the regulations to establish
a voluntary control program for the H5/
H7 subtypes of low pathogenic avian
influenza (H5/H7 LPAI) in commercial
poultry—specifically, in table-egg
layers, meat-type chickens, and meattype turkeys. The provisions of this
program were established in a new part
146. The interim rule also established a
new part 56, titled ‘‘Control of H5/H7
Low Pathogenic Avian Influenza,’’ in 9
CFR chapter I, subchapter B, to provide
for the payment of indemnity for costs
associated with the eradication of H5/
H7 LPAI.
We solicited comments on the interim
rule for 60 days ending November 27,
2006. We received 11 comments by the
due date. They were from State
governments, industry associations,
advocacy groups, and private citizens.
We have carefully considered all of the
comments we received. They are
discussed below by topic.
General Comments
One commenter stated that the
conditions under which commercial
poultry are produced cause disease, and
that the U.S. Department of Agriculture
(USDA) should prohibit current poultry
production practices.
We do not agree with the commenter’s
recommendation and do not believe it is
necessary or appropriate to consider
such regulation of poultry production
practices in this rulemaking. H5/H7
LPAI is caused by a virus. The interim
rule provided for surveillance programs
and emergency response provisions to
detect and eradicate the virus.
The ‘‘Background’’ section of the
interim rule stated that there are 15
recognized hemagglutinin (H) subtypes
1 To view the interim rule and the comments we
received, go to (https://www.regulations.gov/
fdmspublic/component/
main?main=DocketDetail&d=APHIS-2005-0109).
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of avian influenza (AI). One commenter
stated that there are 16 such subtypes.
The commenter is correct. Since the
regulations do not refer to the number
of hemagglutinin subtypes, no change in
the regulations established by the
interim rule is necessary.
The ‘‘Background’’ section also stated
the following: ‘‘Diagnostic surveillance
[for AI in the United States] is
conducted through industry, State, and
university diagnostic laboratories. These
laboratories routinely test for AI, both
serologically and by virus isolation,
whenever birds are submitted from a
flock with clinical signs compatible
with HPAI or LPAI.’’ One commenter
suggested that this statement should
refer to testing for AI by serology,
antigen detection, and/or virus
isolation, because serology cannot be
performed on dead birds.
We agree with the commenter.
Diagnostic surveillance laboratories in
the United States use whatever means
are appropriate to test poultry for AI.
This comment does not necessitate a
change in the regulations established by
the interim rule.
On the subject of surveillance for AI,
the interim rule stated that Texas
established a surveillance program for
commercial poultry flocks near the
Mexican border following the Mexican
HPAI outbreak in 1994-95. One
commenter suggested deleting the
words ‘‘near the Mexican border’’ from
this statement.
We agree; the program in Texas was
Statewide. This comment does not
necessitate a change in the regulations
established by the interim rule.
The interim rule established the new
part 146 for table-egg layers, meat-type
chickens, and meat-type turkeys as the
NPIP regulations for commercial
poultry. One commenter suggested that
we amend the NPIP regulations for
breeding poultry in 9 CFR part 145 to
refer to ‘‘commercial breeding flocks’’
and ‘‘commercial breeding poultry.’’
We have determined that such a
change would be inappropriate. The
regulations established by the interim
rule use the term ‘‘commercial’’ to refer
to large-scale operations producing
poultry for meat or eggs for
consumption. The commenter
apparently intends that the term
‘‘commercial’’ be used to refer to any
large-scale operation. This could create
confusion, since the poultry regulated in
9 CFR part 146 would not be clearly
distinct from the poultry regulated in
part 145. In addition, using the term
‘‘commercial’’ to refer to the poultry
covered by 9 CFR part 145 would be
inaccurate, as the breeders who
participate in the Plan under subpart E
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of part 145, which covers waterfowl,
exhibition poultry, and game bird
breeding flocks and products, typically
are hobbyist breeders rather than largescale breeders. We are making no
changes in response to this comment.
Auditing
In the regulations established by the
interim rule, § 146.11 provides for
inspection of participating flocks and
slaughter plants. Paragraph (a) of
§ 146.11 requires each participating
slaughter plant to be audited at least
once annually or a sufficient number of
times each year to satisfy the Official
State Agency that the participating
slaughter plant is in compliance with
the provisions of 9 CFR part 146.
One commenter stated that this
language implies but does not
specifically state that the Official State
Agency will both audit and determine
compliance. If we do not envision any
potential conflict of interest and the
inference is correct, the commenter
recommended amending the text to
clarify. The commenter suggested using
the following text: ‘‘Each participating
slaughter plant shall be audited at least
once annually by the head of the
Official State Agency or a sufficient
number of times each year to satisfy
him/her self that the participating
slaughter plant is in compliance with
the provisions of this part.’’
Our intention in § 146.11(a) was to
refer to audits of records of testing, and
the results of that testing, that are kept
by the slaughter plant, rather than to
any audit of the slaughter plant facility
itself. Audits by the Official State
Agency of testing records should not
create any conflict of interest; this
process is also used in the NPIP
regulations in 9 CFR part 145.
In a final rule published in the
Federal Register on April 1, 2009 (74 FR
14710-14719, Docket No. APHIS-20070042), and effective on May 1, 2009, we
amended § 146.11 so that it refers
specifically to auditing testing records
and provides additional detail about the
auditing process. We believe these
changes addressed the commenter’s
concerns, and we are making no further
changes to the auditing provisions in
§ 146.11 in this final rule.
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Testing
In the regulations established by the
interim rule, § 146.13 sets out
requirements for testing Plan flocks for
AI. Paragraph (b)(1) of § 146.13 provides
that any samples that are found to be
positive by the agar gel
immunodiffusion test must be further
tested and subtyped by Federal
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Reference Laboratories using the
hemagglutination inhibition test.
One commenter asked that we include
a list in the regulations of laboratories
that are Federal Reference Laboratories.
The regulations for testing for AI in
breeding poultry, in § 145.14(d), also
refer to further testing and subtyping by
Federal Reference Laboratories.
Currently, the only Federal Reference
Laboratory for AI is the National
Veterinary Services Laboratories (NVSL)
in Ames, IA. In response to this
comment, we will post a list of Federal
Reference Laboratories on the NPIP Web
site, at (https://www.aphis.usda.gov/
animal_health/animal_dis_spec/
poultry/index.shtml).
Diagnostic Surveillance Program
In the regulations established by the
interim rule, § 146.14 requires all States
participating in the Plan for commercial
poultry to develop a diagnostic
surveillance program for all poultry, not
just commercial poultry, in that State.
The diagnostic surveillance program is
one of the three components that were
identified as key to the H5/H7 LPAI
program at a meeting APHIS organized
with State and industry representatives
that took place in May 2002 in San
Antonio, TX.
The exact provisions of the program
are at the discretion of the States, but
under the program, AI must be a disease
reportable to the responsible State
authority (State veterinarian, etc.) by all
licensed veterinarians. To accomplish
this, all laboratories (private, State, and
university laboratories) that perform
diagnostic procedures on poultry must
examine all submitted cases of
unexplained respiratory disease, egg
production drops, and mortality for AI
by both an approved serological test and
an approved antigen detection test.
Memoranda of understanding or other
means must be used to establish testing
and reporting criteria (including criteria
that provide for reporting H5 and H7
LPAI directly to the Service) and
approved testing methods. In addition,
States should conduct outreach to
poultry producers, especially owners of
smaller flocks, regarding the importance
of prompt reporting of clinical
symptoms consistent with AI.
One commenter had a specific
concern with requiring all laboratories
(private, State, and university
laboratories) that perform diagnostic
procedures on poultry to examine all
submitted cases of unexplained
respiratory disease, egg production
drops, and mortality for AI by both an
approved serological test and an
approved antigen detection test. The
commenter stated that this requirement
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should apply only to commercial
poultry. Such a change is necessary, the
commenter stated, because owner
consent is critical for diagnostic
laboratories and, in the commenter’s
State, laboratories that perform tests
must also charge fees.
It is true that some poultry owners
may have to bear the burden of
additional testing costs associated with
the diagnostic surveillance program’s
testing requirements. Although some
States do not impose charges for such
testing, many States do. However,
producers smaller than the size
standards established in 9 CFR part 146
are only required to participate in the
diagnostic surveillance program, which
means testing for AI is only required for
submitted cases of unexplained
respiratory disease, egg production
drops, and mortality.
The diagnostic surveillance program
is a key component of the H5/H7 LPAI
program because it allows surveillance
to reach all sectors of the poultry
industry. In addition, the index case in
an outbreak will likely be detected
through the diagnostic surveillance
program, since it focuses on sick
poultry. Detecting H5/H7 LPAI quickly
will expedite the response and control
or eradication of H5/H7 LPAI before
they have the chance to mutate to highly
pathogenic strains of AI. Therefore, it is
crucial to the success of the H5/H7 LPAI
program to have the diagnostic
surveillance program apply to all
poultry. We are making no changes to
the regulations established by the
interim rule in response to this
comment.
Surveillance of Live Bird Markets and
Pet Birds
As noted earlier, the voluntary control
program established by the interim rule
requires diagnostic surveillance for all
poultry in participating States. It also
requires active surveillance for
participating commercial flocks and
slaughter plants over certain size
thresholds, but does not include
requirements for active surveillance for
other flocks and slaughter plants. In the
‘‘Background’’ section of the interim
rule, we briefly discussed the active
surveillance that we carry out in live
bird markets, noting that APHIS has
entered into cooperative agreements
with States that have live bird market
activities, as well as Official State
Agencies and NPIP authorized
laboratories participating in the NPIP
LPAI program.
One commenter stated that, while
increased surveillance activities at live
bird markets lower the risk of AI
transmission, continued outbreaks of
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the disease indicate that this approach
is inadequate. The commenter
encouraged APHIS to take a further step
and permanently prohibit the sale and
slaughter of birds at public markets. In
the commenter’s view, this action
would not only provide for disease
control but would benefit animal
welfare, as the commenter stated that
animals in these markets are frequently
held and killed in an inhumane manner.
If the sale of live birds at public
markets is not to be prohibited, the
commenter recommended that: 1)
Surveillance be increased, 2) housing
and welfare conditions be included in
the auditing of markets, and 3) no
producers be compensated in any way
for birds killed for disease control
purposes at these high-risk venues.
We are confident that the surveillance
mechanisms we have developed in
cooperation with States are sufficient to
detect any H5/H7 LPAI present in the
markets and to allow us to address the
disease expeditiously. We do not
believe it is necessary to prohibit the
sale of poultry at live bird markets
where there are appropriate surveillance
mechanisms and related disease
safeguards available.
With regard to the commenter’s
recommendations, we have determined
that current levels of surveillance are
adequate to detect outbreaks of H5/H7
LPAI in live bird markets. While our
audits of markets relate only to the
prevention of the introduction or spread
of disease, live bird markets must
comply with all laws and regulations
applicable to their operation, including
any applicable State animal welfare
laws and regulations; we would report
circumstances that we know to be
violations of such laws and regulations
to State authorities. Finally, if a person
has complied with all applicable
regulations and agreements pertaining
to surveillance and biosecurity for H5/
H7 LPAI at a live bird market, it would
be inappropriate to declare that person
ineligible for indemnity, as that person
would have incurred costs eligible for
indemnity while complying with the
regulations. In addition, denying
indemnity as the commenter suggests
would establish a negative incentive for
reporting potential H5/H7 LPAI
infection, thus potentially leading to
late reporting of H5/H7 LPAI outbreaks
and hampering our surveillance efforts.
We are making no changes in response
to this comment.
This commenter also asked us to
regulate the sale of birds in the retail pet
industry. At pet stores, the commenter
stated, exotic birds from many different
geographical locations are mixed
together and are often housed in close
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proximity to domestic fowl in retail pet
shops. The commenter believes there
are inadequate licensing, regulatory
oversight, and recordkeeping
requirements to track birds sold in pet
shops, and, as a result, APHIS is missing
the chance to detect disease early, and
control, if not prevent, its spread.
We expect that, under the regulations
in 9 CFR parts 56 and 146, any
outbreaks of H5/H7 LPAI in commercial
poultry would be confined to the
premises on which they occur. Our
regulations governing the importation of
pet birds in 9 CFR part 93 are sufficient
to prevent the introduction of LPAI via
the importation of pet birds. If H5/H7
LPAI were to spread to pet birds, these
birds would be considered infected with
or exposed to H5/H7 LPAI under the
regulations in 9 CFR part 56 and thus
would be subject to the requirements of
the relevant State’s initial response and
containment plan for H5/H7 LPAI.
These restrictions on the interstate
movement of pet birds are sufficient to
prevent the spread of H5/H7 LPAI.
State H5/H7 Avian Influenza Monitored
Classifications
In the regulations established by the
interim rule, subparts B through D of 9
CFR part 146 provide special conditions
for participation in the Plan by
commercial table-egg layer flocks,
commercial meat-type chicken slaughter
plants, and commercial meat-type
turkey slaughter plants, respectively.
Within subparts B and D, §§ 146.24 and
146.44 provide for U.S. H5/H7 Avian
Influenza Monitored State
classifications for table-egg layers and
meat-type turkey slaughter plants; there
is no U.S. H5/H7 Avian Influenza
Monitored State classification for meattype chicken slaughter plants in subpart
C.
One commenter stated that it seems
incongruous not to have a U.S. H5/H7
Avian Influenza Monitored State status
for meat-type chickens if it is rational to
have such a status for meat-type turkeys.
As we stated in the interim rule, in
consultation with our State and industry
cooperators, we have determined that it
is not necessary to provide for a U.S.
H5/H7 Avian Influenza Monitored State
classification for meat-type chickens at
this time. The regulations for meat-type
chicken slaughter plants provide the
same level of surveillance as occurs at
table-egg layer premises and meat-type
turkey slaughter plants, the diagnostic
surveillance program required by the
regulations covers all poultry in the
State, and the regulations in 9 CFR part
56, including the requirement for an
initial State response and containment
plan for H5/H7 LPAI infections, are
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sufficient to ensure that H5/H7 LPAI
infections in meat-type chickens are
handled appropriately. We will
continue to examine the issue, and if we
determine at some point in the future
that it is useful to be able to designate
States as U.S. H5/H7 Avian Influenza
Monitored, we will implement such a
classification.
In the regulations established by the
interim rule, § 56.10(b) provides that if
a State is designated a U.S. Avian
Influenza Monitored State, Layers under
§ 146.24(a) or a U.S. Avian Influenza
Monitored State, Turkeys under
§ 146.44(a), it will lose that status
during any outbreak of H5/H7 LPAI and
for 90 days after the destruction and
disposal of all infected or exposed birds
and cleaning and disinfection of all
affected premises are completed.
One commenter asked us to clarify
what is meant by an outbreak, and
specifically whether the discovery of
H5/H7 LPAI in a live bird market would
constitute an outbreak that would result
in a State losing its U.S. H5/H7 Avian
Influenza Monitored State status.
Consistent with the World
Organization on Animal Health (OIE)
guidelines for AI,2 we consider any
outbreak of H5/H7 LPAI in
domesticated poultry to be an outbreak
for the purposes of § 56.10(b). This
includes live bird markets. However, as
indicated in §§ 146.24(a)(2) and
146.44(a)(2), a State will maintain its
U.S. H5/H7 Avian Influenza Monitored
State status after a single outbreak of
H5/H7 LPAI as long as long as the State
responds to the outbreak in accordance
with 9 CFR part 56, there are not
repeated outbreaks, and the outbreak
does not spread beyond the originating
premises. If any of those circumstances
did not occur, APHIS would have
grounds to revoke the State status,
although APHIS would have to make a
thorough investigation and give the
State an opportunity for a hearing before
doing so.
Definition of H5/H7 LPAI Virus
Infection (Infected)
The regulations established by the
interim rule in §§ 56.1 and 146.1 define
H5/H7 LPAI virus infection (infected) by
stating that poultry will be considered
to be infected with H5/H7 LPAI for the
purposes of parts 56 and 146 if:
∑ H5/H7 LPAI virus has been isolated
and identified as such from poultry; or
∑ Viral antigen or viral RNA specific
to the H5 or H7 subtype of AI virus has
been detected in poultry; or
2 As found in the Terrestrial Animal Health Code.
The guidelines are available on the Internet at
(https://www.oie.int/eng/normes/mcode/
en_chapitre_1.10.4.htm).
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∑ Antibodies to the H5 or H7 subtype
of the AI virus that are not a
consequence of vaccination have been
detected in poultry. If vaccine is used,
methods should be used to distinguish
vaccinated birds from birds that are both
vaccinated and infected. In the case of
isolated serological positive results, H5/
H7 LPAI infection may be ruled out on
the basis of a thorough epidemiological
investigation that does not demonstrate
further evidence of H5/H7 LPAI
infection.
One commenter expressed concern
about the last sentence of this
definition, which discusses using an
epidemiological investigation to
determine that no further evidence of
H5/H7 LPAI infection exists. The
commenter stated that this statement
indicates that certain LPAI events that
leave evidence of prior infection
(seropositivity) can be discounted and
may not require any response actions. If
this is not the intent of the definition,
the commenter stated, we should
remove this statement from the
regulations. If the statement is not
removed, the commenter recommended
that comprehensible descriptions of the
criteria that must be met in order to
discount serological evidence of
infection be added to the regulations.
The commenter also recommended that
the entity responsible for making such
determinations be specified.
Our definition in §§ 56.1 and 146.1 is
based on the definition provided in the
OIE guidelines for AI referred to in this
document. We believe it is appropriate
to include the provision that allows for
ruling out H5/H7 LPAI infection on the
basis of a thorough epidemiological
investigation. It would be impractical to
specify criteria for ruling out H5/H7
LPAI infection on the basis of a
thorough epidemiological investigation,
as the factors allowing us to make such
a determination may vary among
outbreaks and among States.
Additionally, the OIE guidelines do not
specify criteria for making such a
determination.
We do, however, agree with the
commenter that the entity responsible
for making this determination should be
specified. We have amended the
definitions of H5/H7 LPAI virus
infection (infected) in §§ 56.1 and 146.1
in this final rule to indicate that APHIS
is responsible for making this
determination. We believe it will be
better to define the criteria for an
epidemiological investigation of isolated
serological results through APHIS
communication with the Official State
Agencies and Cooperating State
Agencies.
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We are making one other change to
the definition of H5/H7 LPAI virus
infection (infected) in this final rule. We
are adding a sentence indicating that
NVSL makes the final determination
that H5/H7 LPAI virus has been isolated
and identified, viral antigen or viral
RNA specific to the H5 or H7 subtype
of AI virus has been detected, or
antibodies to the H5 or H7 subtype of
AI virus have been detected. This
change is intended to clarify for readers
who makes an official diagnosis related
to the H5/H7 LPAI virus infection
(infected) definition.
Official State Agency and Cooperating
State Agency Roles in Emergency
Response
The regulations in 9 CFR part 56,
which were established by the interim
rule, provide for cooperation among
APHIS, Official State Agencies, and
Cooperating State Agencies in response
to disease outbreaks.
The term Official State Agency is
defined in §§ 146.1 and 56.1 (as well as
§ 145.1) as the State authority
recognized by the Department to
cooperate in the administration of the
Plan. The term Cooperating State
Agency is defined in § 56.1 as any State
authority recognized by the Department
to cooperate in the administration of the
provisions of 9 CFR part 56. Such
cooperation requires the Cooperating
State Agency to have the authority to
restrict intrastate movement, conduct
cleaning and disinfection, and
quarantine premises, among other
things. The Cooperating State Agency is
typically the State animal health
authority.
In some States, the Official State
Agency is also the State animal health
authority; in some States, the Official
State Agency includes representation
from, but is not identical to, the State
animal health authority. For example,
the Official State Agency may include
representatives from the poultry
industry and from agricultural extension
universities in addition to
representatives from the State animal
health authority. While the expertise of
the nongovernmental participants is
invaluable in determining how best to
respond to an LPAI outbreak, only the
State animal health authority has the
authority to perform the functions
described above in response to an
outbreak in accordance with the
provisions of part 56. In addition, the
regulations in 9 CFR part 56 contains
provisions that apply to all poultry, not
just the breeding and commercial
poultry included in the NPIP programs
administered by the Official State
Agencies. For poultry not included in
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those programs, we cooperate with the
State animal health authority to
eradicate an H5/H7 LPAI outbreak and
pay indemnity under part 56. These
circumstances necessitated the
additional definition of ‘‘Cooperating
State Agency.’’
One commenter stated that in several
sections of the interim rule relating to
activities described in 9 CFR part 56, the
regulations should reflect and clearly
recognize that in some jurisdictions the
Official State Agency is not the
responder to or manager of disease
events; rather, the Cooperating State
Agency is the entity authorized by State
law to manage animal diseases of
regulatory significance such as AI.
Therefore, the commenter stated,
disease management actions such as
hold orders, quarantined flock
management plans, movement
restrictions on animals, equipment or
supplies, and cleaning and disinfection
procedures will be under the direction
and control of the Cooperating State
Agency.
In the regulations, functions that are
analogous to functions carried out by
the Official State Agency under the Plan
regulations in 9 CFR part 145 have been
assigned to the Official State Agency in
parts 56 and 146. However, in States
where the Cooperating State Agency is
different from the Official State Agency,
the Cooperating State Agency is the
appropriate entity to take on some
specific functions for disease control, as
the commenter suggests.
The commenter suggested several
specific places in which a responsibility
or function given to the Official State
Agency in the regulations established by
the interim rule should be instead
assigned to the Cooperating State
Agency.
∑ Paragraphs §§ 146.2(f) and 56.2(c)
have stated that States will be
responsible for making the
determination to request Federal
assistance in the event of an outbreak of
H5/H7 LPAI. (The ‘‘Background’’ section
of the rule erroneously referred to the
Official State Agency, but the rule text
refers only to ‘‘States.’’) The commenter
stated that we should clarify that the
Cooperating State Agency, rather than
Official State Agency, should make this
request for assistance. We agree, and we
are making that change to clarify the
regulations in this final rule. (This
change necessitates adding the
definition of Cooperating State Agency
to § 146.1.)
∑ Section 56.10 describes the initial
State response and containment plans
that must be developed for a State and
poultry in that State to be eligible for
100 percent indemnity for costs related
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to an H5/H7 LPAI outbreak. Paragraph
(a) of § 56.10 has stated that the initial
State response and containment plan
must be developed by the Official State
Agency and administered by the
Cooperating State Agency of the
relevant State. The commenter
suggested that the regulations should
require that the plan be developed
jointly by the Official State Agency and
the Cooperating State Agency and
implemented by the Cooperating State
Agency. The commenter stated that
giving the responsibility of developing
the plan solely to the Official State
Agency is undesirable and might
become the root of significant difficulty
when the Official State Agency is
independent from the Cooperating State
Agency, which would create a situation
where one entity creates the plan
without the authority, resources, or
responsibility for executing the plan,
after which another agency executes the
plan. The commenter stated that
involving the responding agency in the
development of the response plan
should be expected to develop a
superior plan to one developed without
input from the responders. We agree,
and we have amended § 56.10(a) in this
final rule. That paragraph now states
that the initial State response and
containment plan must be developed by
the Official State Agency and further
provides that, in states where the
Official State Agency is different than
the Cooperating State Agency, the
Cooperating State Agency must also
participate in the development of the
plan. In addition, we have corrected
references to the initial State response
and containment plan in paragraphs
(a)(2) and (a)(3) of § 56.2 that indicated
that the Official State Agency was the
sole developer of the initial State
response and containment plan.
∑ The definition of commercial meattype flock in §§ 56.1 and 146.1 allows
any group of poultry which is
segregated from another group in a
manner sufficient to prevent the
transmission of H5/H7 LPAI and has
been so segregated for a period of at
least 21 days to be considered as a
separate flock, at the discretion of the
Official State Agency. The commenter
stated that this discretion should be
given to the Cooperating State Agency,
due to the emergency response
responsibilities of the Cooperating State
Agency. We assigned this responsibility
to the Official State Agency because it
is a type of task that the Official State
Agency has typically been responsible
for in other NPIP activities, and the
definition applies to activities
conducted under the NPIP regulations
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in 9 CFR part 146 as well as in 9 CFR
part 56. We are making no changes in
response to this comment.
∑ The regulations established by the
interim rule in § 56.1 defined flock plan
as: ‘‘A written flock management
agreement developed by APHIS and the
Official State Agency with input from
the flock owner and other affected
parties. A flock plan sets out the steps
to be taken to eradicate H5/H7 LPAI
from a positive flock, or to prevent
introduction of H5/H7 LPAI into
another flock. A flock plan shall
include, but is not necessarily limited
to, poultry and poultry product
movement and geographically
appropriate infected and control/
monitoring zones. Control measures in
the flock plan should include detailed
plans for safe handling of conveyances,
containers, and other associated
materials that could serve as fomites;
disposal of flocks; cleaning and
disinfection; downtime; and
repopulation.’’ The commenter stated
that the responsibilities discussed in
this definition are more properly
assigned to the Cooperating State
Agency. Again, we assigned this
responsibility to the Official State
Agency because it is a task that the
Official State Agency has typically been
responsible for in NPIP activities. We
are making no changes in response to
this comment.
∑ The ‘‘Background’’ section of the
interim rule stated that, while the
provisions of 9 CFR part 146 are APHIS
requirements for participation in the
Plan, and protocols for sampling,
testing, and other surveillance activities
must be approved by APHIS, the active
and diagnostic surveillance undertaken
under part 146 is run by the Official
State Agencies in cooperation with
poultry producers; the costs of the
surveillance are borne by the Official
State Agencies as well. The commenter
stated that the costs of surveillance are
borne by Cooperating State Agencies
rather than Official State Agencies.
However, the commenter is incorrect.
The cost of the routine, active
surveillance described in 9 CFR part 146
is, in fact, borne by Official State
Agencies and industry when they
cooperate to participate in the Plan.
Vaccination
In the regulations established by the
interim rule, paragraphs (a)(2) and (b)(2)
of § 56.2 set out conditions for the
transfer of vaccine for H5/H7 LPAI to
Cooperating State Agencies, provided
that the use of vaccine is included in the
initial State response and containment
plan, as described in § 56.10(a)(12).
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We received one comment that
addressed vaccination in general. The
commenter strongly supported the use
of vaccination as an emergency response
for table-egg layer flocks. The
commenter recommended that APHIS
undertake outreach efforts to remind
States that their initial State response
and containment plans should request
authority to use vaccination in advance,
rather than waiting for an outbreak. The
commenter also recommended that
APHIS notify States that, if they have
already submitted initial State response
and containment plans that did not
include provisions for vaccination, they
may amend those plans to include such
provisions.
We agree that vaccination has the
potential to be a cost-effective method of
eradicating H5/H7 LPAI, especially for
table-egg layer flocks. Under the
regulations, the Official State Agency
and Cooperating State Agency for a
State will determine whether
vaccination is part of the State’s initial
response and containment plan. APHIS
will approve the use of vaccination if
the initial State response and
containment plan contains appropriate
provisions for its use. We encourage
States to include provisions allowing for
the use of vaccination in their initial
State response and containment plans,
especially States in which table-egg
layer premises are located. We also
encourage States to submit updated
initial State response and containment
plans for APHIS approval if they have
new ideas about effective response to
and containment of H5/H7 LPAI in their
States.
Payment of Indemnity
In the regulations established by the
interim rule, § 56.3 sets out provisions
for payment of indemnity.
One commenter asked generally
whether indemnity would be provided
if the H5/H7 LPAI virus entered a flock
due to illegal activity on the part of the
flock owners or manager.
In § 56.9, ‘‘Claims not allowed,’’
paragraph (c) prohibits the payment of
indemnity for any poultry that become
or have become infected with or
exposed to H5/H7 LPAI because of a
violation of 9 CFR part 56. This
provision addresses the commenter’s
concern.
Paragraph (a) of § 56.3 describes the
activities for which the Administrator
may pay indemnity. These are:
∑ Destruction and disposal of poultry
that were infected with or exposed to
H5/H7 LPAI;
∑ Destruction of any eggs destroyed
during testing of poultry for H5/H7
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LPAI during an outbreak of H5/H7
LPAI; and
∑ Cleaning and disinfection of
premises, conveyances, and materials
that came into contact with poultry that
were infected with or exposed to H5/H7
LPAI or, in the case of materials, if the
cost of cleaning and disinfection would
exceed the value of the materials or
cleaning and disinfection would be
impracticable for any reason, the
destruction and disposal of the
materials.
One commenter recommended that
APHIS consider indemnifying any
vaccination-related costs that are borne
by producers in cases in which
vaccination is used as a response to an
outbreak of H5/H7 LPAI. The
commenter cited possible costs
including, but not limited to, labor
required both for vaccination and for
ongoing surveillance, ultimate disposal
costs, and expenses incurred in
controlled marketing, such as the need
to purchase more packaging materials
than normal.
The regulations as established by the
interim rule cover the cost of disposal
of poultry that were infected with or
exposed to H5/H7 LPAI and have been
destroyed. The regulations in § 56.2
provide for APHIS to transfer payment
to the Cooperating State Agency for
administering vaccine and conducting
surveillance related to an outbreak of
H5/H7 LPAI. APHIS does not believe it
is appropriate to provide indemnity for
business costs such as the packaging
costs cited by the commenter. We are
making no changes to the regulations in
response to this comment.
One commenter expressed concern
that egg producers in the commenter’s
State might not be able to fulfill the
testing requirements necessary to be
eligible for 100 percent indemnity.
Under § 56.3(b) of the interim rule, if
a table-egg layer premises has 75,000 or
more birds, it must participate in the
U.S. H5/H7 Avian Influenza Monitored
program in § 146.23(a) in order for the
poultry on that premises to be eligible
for 100 percent indemnity. Table-egg
layers on smaller premises are eligible
for 100 percent indemnity if the State in
which the table-egg layers are located
participates in the diagnostic
surveillance program as described in
§ 146.14, and has an initial State
response and containment plan that is
approved by APHIS under § 56.10. The
commenter stated elsewhere that the
average commercial layer flock in the
commenter’s State ranges from 10,000 to
50,000 table-egg layers per farm. Thus,
it appears that most table-egg layer
premises in that State would not have
to participate in the U.S. H5/H7 Avian
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Influenza Monitored program in
§ 146.23(a) in order to be eligible for 100
percent indemnity, as long as the State
has in place a diagnostic surveillance
program and an initial State response
and containment plan.
Paragraph (b) of § 56.3 generally
provides that establishments above
certain size standards must participate
in an NPIP AI surveillance program in
order to be eligible to receive 100
percent indemnity; otherwise, they are
only eligible to receive 25 percent
indemnity. However, in the
‘‘Background’’ section of the interim
rule, we asked whether it would be
appropriate to provide an indemnity
incentive for owners of smaller poultry
flocks to participate in a State program
that has testing requirements equivalent
to those in part 146, similar to the
incentive we provide for larger flocks to
participate in the programs in part 146.
Such an incentive, we stated, could
encourage owners of smaller flocks to
participate in the State AI testing
programs designed for those flocks. For
example, the regulations could include
provisions for APHIS to recognize the
testing requirements of State active
surveillance programs as equivalent to
the testing requirements for the H5/H7
LPAI surveillance programs in part 146.
We could then provide that if infected
or exposed poultry are eligible to
participate in an equivalent active
surveillance program, but do not
participate in that program, we would
pay indemnity for less than 100 percent
of costs related to an H5/H7 LPAI
outbreak in those poultry
We invited public comment on:
∑ Whether we should recognize State
AI surveillance programs for smaller
poultry flocks or other types of poultry
as equivalent to the NPIP surveillance
programs in part 146;
∑ If so, which programs we should
recognize; and
∑ What changes in the regulations
may be appropriate to provide poultry
owners with an incentive to participate
in State AI surveillance programs.
One commenter, from a State
department of agriculture, stated that its
surveillance program would likely be
considered equivalent to the
requirements in part 146 and that
recognizing equivalent programs for
indemnity purposes would encourage
many backyard flocks to participate in
such State surveillance programs. The
commenter stated that any program that
encourages bird owners to monitor for
AI is valuable not only for the
surveillance information it provides, but
also as another opportunity to educate
individuals engaged in backyard and
other alternative production methods
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about biosecurity and good management
practices.
We appreciate the commenter
addressing the issues we raised in the
interim rule. After considering the
possible implications of recognizing
State surveillance plans as equivalent
for the purposes of establishing an
indemnity incentive, however, we have
decided not to do so in this final rule.
While the NPIP active surveillance
plans are appropriate for any flock or
slaughter plant that is larger than the
size standards promulgated in the
interim rule, it is less clear that it would
be possible to design an active
surveillance program that was
appropriate for flocks that are smaller
than those same size standards. Indeed,
in practice, State programs for flocks
and slaughter plants smaller than the
size standards in the interim rule
typically focus on diagnostic
surveillance, such as testing birds that
have clinical symptoms consistent with
AI, rather than actively testing a certain
number of birds from each participating
flock for AI. Diagnostic surveillance
activities in State surveillance programs
are typically in line with the diagnostic
surveillance program required for
participating States under § 146.14.
Rather than establish an indemnity
incentive for flocks and slaughter plants
that are smaller than the size standards
in part 146 to participate in State
surveillance programs, we prefer to
conduct outreach to owners of such
flocks and slaughter plants to encourage
them to practice appropriate biosecurity
and to promptly report clinical
symptoms consistent with AI. We
would also encourage owners of flocks
or slaughter plants that are smaller than
the size standards to participate in any
State AI surveillance programs that are
available to them. (As noted earlier,
commercial table-egg laying premises
with fewer than 75,000 birds, meat-type
chicken slaughter plants that slaughter
fewer than 200,000 meat-type chickens
in an operating week, and meat-type
turkey slaughter plants that slaughter
fewer than 2 million meat-type turkeys
in a 12-month period are not required to
participate in the active surveillance
programs in subparts B, C, and D of 9
CFR part 146 in order to receive 100
percent indemnity.)
We are making changes to paragraph
(b)(7) in § 56.3 in this final rule. This
paragraph has stated that poultry will be
eligible for 25 percent indemnity if they
are associated with a flock or slaughter
plant that participates in the Plan, but
they are located in a State that does not
participate in the NPIP diagnostic
surveillance program for H5/H7 LPAI,
as described in § 146.14 of this chapter,
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or that does not have an initial State
response and containment plan for H5/
H7 LPAI that is approved by APHIS.
They may be eligible for 100 percent
indemnity, however, if they participate
in the Plan with another State that does
participate in the NPIP diagnostic
surveillance program for H5/H7 LPAI,
as described in § 146.14 of this chapter,
and has an initial State response and
containment plan for H5/H7 LPAI that
is approved by APHIS.
It is important to note that, under
§ 56.3(b)(7), poultry that do not
participate in the Plan and do not meet
the size standards in paragraphs (b)(4)
through (b)(6) of § 56.3 have been
eligible for 100 percent indemnity even
if the State in which they are located
does not have a diagnostic surveillance
program or an initial State response and
containment plan. Since the publication
of the interim rule, we have reviewed
this provision and found that its
inclusion is inconsistent with the
rationale we gave in the interim rule for
providing for the payment of 100
percent indemnity in certain
circumstances.
In the ‘‘Background’’ section of the
interim rule, we stated that providing
for the payment of 100 percent of
eligible costs is appropriate because
participants in the H5/H7 LPAI control
program established by the interim rule
assume an economic burden in
complying with the requirements of the
control program. The requirements of
the control program make it more likely
that an outbreak of H5/H7 LPAI will be
quickly detected and contained; this
would tend to lower the amount of
indemnity APHIS may have to pay, but
the cost of participating in the program
is mostly borne by producers and
Official State Agencies.
However, States that do not have a
diagnostic surveillance program and an
initial State response and containment
plan have not assumed the economic
burden of participation in the control
program. Because they have not set up
an infrastructure by which producers
can participate in the control program,
the producers in those States do not
assume costs related to the control
program either, unless they participate
in the Plan with another State that has
the required diagnostic surveillance
program and initial State response and
containment plan. We did not intend to
provide that producers in States without
diagnostic surveillance programs or
without initial State response and
containment plans would be eligible for
100 percent indemnity. Accordingly, we
are amending paragraph (b)(7) in § 56.3
to indicate that the Administrator is
authorized to pay indemnity for only 25
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percent of the costs associated with any
infected or exposed poultry located in a
State without a diagnostic surveillance
program or an initial State response and
containment plan, unless they
participate with another State as
described earlier.
We are also amending § 56.3(b)(7) to
refer simply to a diagnostic surveillance
program, rather than a ‘‘National Poultry
Improvement Plan diagnostic
surveillance program,’’ as the
regulations in § 146.14 require that the
diagnostic surveillance program
encompass all poultry, not just NPIP
flocks.
Paragraph (c) of § 56.3 states that if
the recipient of indemnity for any of the
activities listed in paragraphs (a)(1)
through (a)(3) of § 56.3 also receives
payment for any of those activities from
a State or from other sources, the
indemnity provided under this part will
be reduced by the total amount of
payment received from the State or
other sources.
One commenter stated that some
States have producer or governmentfunded programs that provide funds to
be made available in the case of an AI
infection. Most of these types of
programs, the commenter stated,
include a provision requiring the local
monies to be returned to the local
source if Federal or other funds are later
available to indemnify the affected
parties. The purpose of these local funds
is to provide a much quicker response
than possible under the Federal
program. The commenter recommended
that the Federal program acknowledge
that such funds exist and provide that
the recipients of these funds will not
have their Federal indemnity reduced as
long as the local indemnity funds are
ultimately returned to the local source.
We may provide the full indemnity
for which the poultry are eligible to
poultry owners who have received
indemnity from State or industry
sources, as long as the owner provides
us with proof that the indemnity
received from those sources has been
returned to its source. A receipt from
the payer of the indemnity that was
previously received would be one such
proof. It is not necessary to amend the
regulations to accommodate this
process, as if the indemnity funds
received have been returned, the
provision in § 56.3(c) no longer applies.
Determination of Indemnity Amounts
and Appraisals
In the regulations established by the
interim rule, § 56.4 described the
process by which indemnity amounts
would be determined, including the
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appraisal process. We received several
comments on the appraisal process.
One commenter stated that a
complicated appraisal process should
never be allowed to interfere with the
prompt eradication of disease. As the
regulations are written, the commenter
stated, no depopulation could occur
until the official appraiser has
completed the paperwork and signed off
on the appropriate form with the
owners’ and mortgagees’ (if necessary)
signatures. However, the commenter
stated, in reality there are very few
USDA appraisers; if the State’s appraisal
system is not permitted to be used, then
actions to control the H5/H7 LPAI
outbreak could be delayed. The
commenter noted that this could have a
negative effect on poultry production in
the entire State in which the outbreak
occurred, as the 90 days that must
elapse before U.S. Avian Influenza
Monitored State status can be restored
does not begin until the birds are
depopulated and the premises are
cleaned and disinfected.
The commenter had two suggestions
for how to address the problem. One
was to have pre-approved State and
Federal appraisers in every State.
Another suggestion was to have a
prescribed list of information that must
be collected concerning each flock prior
to depopulation which the USDA
appraiser could use after the fact to
calculate an exact dollar amount.
We appreciate the commenter’s
concerns and share a desire to ensure
that the appraisal process does not
hinder response efforts for a disease
outbreak. The regulations established by
the interim rule in § 56.4(a) and (b)
include statements that appraisals of
poultry or eggs must be signed by the
owners of the poultry prior to the
destruction of the poultry or eggs,
unless the owners, APHIS, and the
Cooperating State Agency agree that the
poultry may be destroyed immediately.
(The interim rule neglected to include a
similar statement in § 56.4(c)(2)
regarding the appraisal process for
materials for which the cost of cleaning
and disinfection would exceed the value
of the materials or cleaning and
disinfection would be impracticable for
any reason. We are correcting that
omission in this final rule.) We believe
this provision addresses the
commenter’s concern.
We agree that having a list of preapproved appraisers would be useful,
and we are working to develop one to
improve our response efforts for all
diseases, not just H5/H7 LPAI.
With regard to the commenter’s
second suggestion, we typically conduct
appraisals for poultry by reviewing
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documentation regarding their
production, rather than by visual
inspection. The appraisal estimate is
based on the cost of inputs used during
the production process (e.g., feed,
shelter, labor) and the current market
price of the relevant poultry or outputs.
A more detailed discussion can be
found in the full economic analysis that
accompanied the interim rule, which is
available on Regulations.gov (see
footnote 1 in this document for a link
to the economic analysis on
Regulations.gov).
One commenter stated that if a flock
owner voluntarily destroys a flock prior
to confirmation of infection, there
should be a means for a Cooperating
State Agency to verify the number and
type of poultry and eggs destroyed, so
that indemnity may be paid after the
infection has been confirmed and an
appraisal made.
Only poultry that have been infected
with or exposed to H5/H7 LPAI are
eligible for indemnity under 9 CFR part
56. Under the definition of H5/H7 LPAI
exposed, poultry can be determined to
be exposed to H5/H7 LPAI if there is a
reason to believe that association has
occurred with H5/H7 LPAI or vectors of
the virus by the Cooperating State
Agency and confirmed by APHIS.
Absent our determination that poultry
were infected with or exposed to H5/H7
LPAI, we will not authorize the
payment of indemnity for the
destruction and disposal of that poultry.
As noted earlier, for poultry that are
infected with or exposed to H5/H7
LPAI, we will use records of production
to determine how much indemnity
should be paid.
In § 56.4, paragraph (a)(1) states that,
for laying hens, the appraised value
should include the hen’s projected
future egg production. One commenter
agreed with this provision but
recommended that the appraisal should
also take into account whether the hen
would have undergone a molt had she
not been euthanized. The commenter
stated that not all flocks are molted, but
those that are have a longer productive
life — typically 110-115 weeks rather
than approximately 80 weeks.
The commenter is correct that molted
hens have a longer productive life than
hens that are not molted. However,
there would be considerable difficulties
in determining whether a hen would
have been molted and properly valuing
the hen based on that information.
Based on industry figures for hen
values, the appraised value of a hen
starts out low for a day-old chick,
increases as the bird grows, and reaches
a maximum soon after egg laying begins.
As eggs are laid, the hen’s value
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declines. When molting takes place, the
hen’s value increases during the molting
phase, followed by a decline in value as
eggs are laid. The process repeats itself
for a second molt.
If we were to adopt the commenter’s
recommendation, our appraisal model
would not increase the value of a hen
in its molting phase, but would have to
assign that increase in value to the
initial lay. This would result in no
increase in value for hens in the molting
phase, which would mean that our
appraisal values of a hen in the molting
phase would not reflect the fair market
value of the hen. In addition, if we made
the change suggested by the commenter,
we would have to take the owner’s word
for whether the hen was to be molted,
meaning the owner would have a strong
incentive to state that the hen would be
molted, thus increasing the hen’s value,
regardless of the actual plans for
molting. We have determined that our
present valuation model for hens more
accurately determines their fair market
value, as required by the Animal Health
Protection Act. We are making no
changes in response to this comment.
In § 56.4, paragraph (a)(2) sets out the
conditions for determining the amount
of indemnity paid for disposal of
poultry. The conditions include a
requirement that any disposal of poultry
infected with or exposed to H5/H7 LPAI
for which indemnity is requested must
be performed under a compliance
agreement between the claimant, the
Cooperating State Agency, and APHIS.3
Paragraph (c)(1) sets out the conditions
under which the amount of indemnity
paid for cleaning and disinfection will
be determined; similarly, the conditions
include a requirement that any cleaning
and disinfection of premises,
conveyances, and materials for which
indemnity is requested must be
performed under a compliance
agreement between the claimant, the
Cooperating State Agency, and APHIS.
One commenter stated that requiring
that completed, signed appraisal
documents and a written compliance
agreement be in place prior to disposal
of infected poultry would severely
hamper efforts to quickly and effectively
deal with the infection. The commenter
recommended that we recognize as
adequate any disposal activities
undertaken under the approved initial
State response and containment plan.
The commenter also stated that cleaning
and disinfection should be allowed to
commence without a compliance
3 Two sentences in § 56.4(a)(2) as it was
established by the interim rule incorrectly referred
to ‘‘compensation’’ rather than ‘‘indemnity.’’ We are
correcting the error in this final rule.
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agreement as long as a Cooperating State
Agency oversees and directs the work
and documentation of expenses is
provided. In the event of a disputed
claim, the commenter stated, a process
for resolving differences should be
provided.
The regulations require that the
destruction and disposal of the
indemnified poultry be conducted in
accordance with the initial State
response and containment plan for H5/
H7 LPAI. Similarly, the regulations
indicate that APHIS will review claims
for indemnity for cleaning and
disinfection to ensure that all
expenditures relate directly to activities
described in § 56.5 and in the initial
State response and containment plan
described in § 56.10.
Allowing disposal of infected poultry
or cleaning and disinfection to begin
without a compliance agreement in
place, but promising to pay indemnity
for expenses related to these activities,
would amount to approving
expenditures on APHIS’ behalf without
having a mechanism in place by which
APHIS can provide oversight. This
could create disputes regarding the
payment of indemnity. Our oversight of
activities for which we pay indemnity is
essential to the responsible use of funds
made available to APHIS for indemnity.
Based on previous disease response
efforts, including the effort to eradicate
exotic Newcastle disease outbreaks in
2002-2003, we are confident that we can
conclude compliance agreements with
States and flock owners with sufficient
timeliness to ensure an effective disease
response.
One commenter had two comments
about how the provisions in § 56.9,
‘‘Claims not allowed,’’ relate to the
provisions in § 56.4.
Paragraph (a) of § 56.9 states that the
USDA will not allow claims arising out
of the destruction of poultry unless the
poultry have been appraised as
prescribed in part 56 and the owners
have signed the appraisal form
indicating agreement with the appraisal
amount as required by § 56.4(a)(1). The
commenter asked whether the poultry
could be appraised after they are
destroyed based on the information
collected by the Cooperating State
Agency prior to their destruction.
We expect to use a process in which
birds are destroyed and appraisal is
performed after destruction in some
cases, regardless of whether the
Cooperating State Agency or APHIS
collects the necessary information for
the appraisal. This is why the
regulations in § 56.4(a)(1) provide that
poultry may be destroyed before the
owners of the poultry sign their
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appraisals if the owners, APHIS, and the
Cooperating State Agency agree that the
poultry may be destroyed immediately.
Paragraph (b) of § 56.9 states that the
USDA will not allow claims arising out
of the destruction of poultry unless the
owners have signed a written agreement
with APHIS in which they agree that if
they maintain poultry in the future on
the premises used for poultry for which
indemnity is paid, they will maintain
the poultry in accordance with a plan
set forth by the Cooperating State
Agency and will not introduce poultry
onto the premises until after the date
specified by the Cooperating State
Agency.
The commenter stated that this
requirement was inconsistent with the
provisions in § 56.4 that require a
compliance agreement to be in place for
the disposal of poultry and for cleaning
and disinfection, and that both
paragraphs should simply require an
agreement rather than a compliance
agreement.
The two requirements refer to two
different agreements. The requirement
in § 56.9(b) refers to an agreement for
maintenance and repopulation of the
flock, while the requirements in § 56.4
refer to a compliance agreement under
which APHIS will pay for cleaning and
disinfection work that APHIS does not
perform. As stated earlier, we are
confident that we can conclude the
necessary compliance agreements
promptly under disease emergency
conditions, based on past experience.
Destruction and Disposal of Poultry and
Cleaning and Disinfection of Premises,
Conveyances, and Materials
In the regulations established by the
interim rule, § 56.5 sets out provisions
relating to the destruction and disposal
of poultry and cleaning and disinfection
of premises, conveyances, and
materials. Paragraph (a) of § 56.5 sets
out the factors on which the
Cooperating State Agency and APHIS
will base their selection of a method of
destruction for poultry. These factors
include:
∑ The species, size, and number of the
poultry to be destroyed;
∑ The environment in which the
poultry are maintained;
∑ The risk to human health or safety
of the method used;
∑ Whether the method requires
specialized equipment or training;
∑ The risk that the method poses of
spreading the H5/H7 LPAI virus;
∑ Any hazard the method could pose
to the environment;
∑ The degree of bird control and
restraint required to administer the
destruction method; and
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∑ The speed with which destruction
must be conducted.
Three commenters stated that the
welfare of the poultry to be destroyed
should be a consideration in our
selection of methods for the destruction
of poultry. Two note that the OIE has
recently published animal welfare
guidelines that recommend that, when
‘‘animals are killed for disease control
purposes, methods used should result in
immediate death or immediate loss of
consciousness lasting until death; when
loss of consciousness is not immediate,
induction of unconsciousness should be
non-aversive and should not cause
anxiety, pain, distress or suffering in the
animals.’’ These commenters
recommended that we adopt the OIE
guidelines on this issue in the
regulations.
One of these commenters stated that
the USDA has made efforts to include
animal welfare issues in its highly
pathogenic avian influenza (HPAI)
response plan, including permitting
only methods approved by the
American Veterinary Medical
Association and holding discussions
with scientists and animal protection
organizations to consider the suffering
inflicted by various destruction
methods. The commenter expressed
surprise that we did not address these
issues in the same manner in the LPAI
regulations, especially since unlike
HPAI, which has not struck the United
States in many years, LPAI outbreaks
are regularly detected, and each
outbreak typically requires the
destruction of entire flocks of birds,
which can number in the tens of
thousands. The commenter stated that
the sheer magnitude of the number of
animals involved makes it ethically
incumbent upon responsible authorities
to minimize their suffering.
The commenters also made
recommendations regarding destruction
methods that could minimize the pain
and suffering of the destroyed poultry.
One commenter attached a paper
addressing the topic. Another
recommended the use of inert gases,
particularly in cases where sheds cannot
be sealed properly (for example, with
table-egg layers or breeding poultry),
discussed conditions that should apply
to the use of carbon dioxide, and
recommended that other methods not be
used. A third commenter agreed on the
suitability of inert gases and specifically
recommended that we not use foam to
destroy poultry.
We agree with the commenters that it
is appropriate to take the humaneness of
a destruction method into account when
determining what destruction method to
use. Accordingly, this final rule adds
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‘‘Consistency of the method with
humane euthanasia guidelines’’ as an
additional factor to be considered when
selecting the destruction method in
§ 56.5(a).
We appreciate the information the
commenters supplied on specific
destruction methods, and we will take
it into consideration when determining
what destruction method to use during
an LPAI outbreak.
Paragraph (c) of § 56.5 sets out
conditions under which controlled
marketing may occur. The interstate
movement of poultry that has been
infected with or exposed to H5/H7 LPAI
for controlled marketing may occur only
at the discretion of the Cooperating
State Agency and APHIS and only if the
initial State response and containment
plan described in § 56.10 provides for it.
In addition, controlled marketing may
only occur in accordance with the
following requirements:
∑ Poultry infected with or exposed to
H5/H7 LPAI must not be transported to
a market for controlled marketing until
21 days after the acute phase of the
infection has concluded, as determined
by the Cooperating State Agency in
accordance with the initial State
response and containment plan
described in § 56.10; and
∑ Within 7 days prior to slaughter,
each flock to be moved for controlled
marketing must be tested for H5/H7
LPAI using a test approved by the
Cooperating State Agency and found to
be free of the virus.
These restrictions ensure that poultry
that are moved for controlled marketing
do not pose a risk of spreading H5/H7
LPAI.
One commenter asked whether the
requirements in this paragraph refer
only to poultry flocks that participate in
the Plan or to any poultry. Specifically,
the commenter asked whether a State
could allow poultry from an H5/H7
LPAI positive live bird market to be sold
for several days prior to depopulation
and cleaning and disinfection, a process
known as ‘‘selldown.’’
Poultry that have been moved to a live
bird market for sale have already
reached the end of the marketing cycle,
and thus would not need to be moved
for controlled marketing; they are
already at a market and being sold
directly to consumers. Therefore, the
controlled marketing requirements do
not apply to the sale of poultry at live
bird markets. However, the movement
of these infected or exposed birds would
be restricted under the initial State
response and containment plan.
Paragraph (c)(2) of § 56.5 indicates
that poultry moved for controlled
marketing will not be eligible for
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indemnity under § 56.3. Since the
publication of the interim rule,
outbreaks of H5/H7 LPAI have occurred
in which producers sold infected or
exposed birds through controlled
marketing. Indemnity was not paid for
the poultry themselves, but the
regulations were unclear on whether we
would pay indemnity for costs related to
cleaning and disinfection of premises,
conveyances, and materials that came
into contact with poultry that are moved
for controlled marketing.
Although producers who move
infected or exposed poultry interstate
for controlled marketing are able to
recoup the cost of production of the
poultry through their sale, they still
incur costs relating to cleaning and
disinfection, which after an H5/H7 LPAI
outbreak must be more thorough than
typical cleaning and disinfection.
Therefore, in this final rule, we are
adding a provision to this paragraph
indicating that costs related to cleaning
and disinfection of premises,
conveyances, and materials that came
into contact with poultry that are moved
for controlled marketing will be eligible
for indemnity. This provision is
intended to provide additional clarity.
Paragraph (d) in § 56.5 sets out
guidelines for the development of a
cleaning and disinfection plan for a
premises and for the materials and
conveyances on that premises. Cleaning
and disinfection must be performed in
accordance with the initial State
response and containment plan
described in § 56.10, which must be
approved by APHIS. One commenter
had several comments on paragraph (d).
Paragraph (d)(1)(i) of § 56.5 provides
guidance to secure and remove all
feathers that might blow around outside
the house in which the infected or
exposed poultry were held by raking
them together and burning the pile.
The commenter stated that this action
may be in violation of applicable
environmental regulations.
In response to this comment, we are
including a general statement at the
beginning of paragraph (d) that indicates
that all cleaning and disinfection
activities must comply with Federal,
State, and local environmental
regulations.
It is important to note that paragraph
(d) is intended to provide guidelines for
the development of a cleaning and
disinfection plan; if some aspect of the
guidelines in paragraph (d) is not
applicable to a specific State or locality,
or to the poultry operations affected by
an LPAI outbreak, a State has the option
to address cleaning and disinfection
differently in its initial State response
and containment plan.
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The commenter also noted that there
is no alternate feather disposal option
presented, e.g., composting, burial in
approved locations, onsite treatment, or
secure transport to offsite landfill or
treatment.
As stated in the regulations,
paragraph (d) of § 56.5 provides
guidelines for the development of a
cleaning and disinfection plan for a
premises and for the materials and
conveyances on that premises. The
feather disposal method provided in the
regulations is not the only possible
effective method, and other methods
may be appropriate in certain situations.
In the event of an H5/H7 LPAI outbreak,
APHIS reserves the option to approve
another disposal method if a State
requests it and we determine the
disposal method to be effective. It is not
necessary to set out all potentially
appropriate feather disposal methods in
the guidelines in paragraph (d).
Paragraph (d)(1)(iii) of § 56.5 provides
guidance to close the house (except for
allowing enough ventilation to remove
moisture) for a minimum of 21 days
following application of insecticides
and rodenticides to allow as much H5/
H7 LPAI virus as possible to die a
natural death. The commenter stated
that there is no mention made of
concurrent in-house composting or
whether there is initial raising of the inhouse temperature and that allowing the
house sit for 21 days in a cold, moist
environment may do little to reduce the
LPAI virus titer in the house.
We had intended for composting to be
performed during the 21-day period
after the closing of the poultry house.
We have amended paragraph (d)(1)(iii)
to reflect that. We are also amending
paragraph (d)(1)(iii) to indicate that the
house should be heated to 100 °F before
beginning in-house composting.
Paragraph (d)(1)(iv) of § 56.5 provides
guidance to heat the house to 100 °F for
72 hours prior to cleaning and
disinfection. The commenter stated that
it appears that this temperature raising
occurs after the 21-day downtime and
prior to litter removal or in-house
composting. It is unclear, the
commenter stated, whether this
temperature recommendation is based
on acceptable field test data specific for
the LPAI virus. If raising the
temperature occurs prior to removal or
composting of litter, the litter might act
as a blanket to protect the virus from the
heat. The commenter stated that raising
the temperature to the indicated level at
the start of composting rather than at the
end will accelerate the in-house
composting process and will aid in the
natural die-off of the LPAI virus in the
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poultry house during the 21-day
downtime.
These comments are addressed by the
change discussed previously.
The commenter also stated that there
is no guidance provided as to how to
deal with a house with open sides in a
cold environment.
The guidelines in paragraph (d) are
intended to address the most common
situations associated with commercial
poultry production. Houses with open
sides are typically not used in
commercial poultry production, as open
sides put the poultry within at risk of
infection by wild birds. In the event of
an H5/H7 LPAI outbreak, APHIS
reserves the option to approve another
composting method if a State requests it
and we determine the disposal method
to be effective; a composting method
approved in this manner would also be
an approved activity for indemnity
payment purposes, as would any other
cleaning and disinfection provision
used to deal with an unusual situation.
It is not necessary to set out all
potentially appropriate composting
methods in the guidelines in paragraph
(d).
Paragraph (d)(2)(i) of § 56.5 provides
guidance to clean up or compost all
manure, debris, and feed in the house if
possible before cleaning and
disinfection. The commenter stated that
it is not clear whether this composting
should occur at the start of the 21-day
pre-cleaning and disinfection period.
Under these guidelines, all material in
the house would be composted during
the 21-day pre-cleaning and disinfection
period, after which any manure, debris,
and feed would undergo an additional
composting.
Paragraph (d)(2)(i) also indicates that
equipment should be washed and
disinfected. The commenter stated that
the regulations should more
appropriately provide guidance to clean
and disinfect equipment.
We agree, and we have made this
change in the final rule.
Paragraph (d)(2)(ii) of § 56.5 provides
guidance to spray contaminated surfaces
with soap and water. The commenter
stated that it may have been more
appropriate to indicate instead spraying
with detergent (rather than soap) and
water. Also, the commenter stated, the
guidance should indicate that detergent
should be rinsed with fresh water to
prevent a potentially negative
interaction between the detergent and
the successively applied disinfectant.
We agree with the commenter, and we
have made the suggested changes.
Paragraph (d)(2)(iii) of § 56.5 provides
guidance to use disinfectants authorized
by 9 CFR 71.10(a). The commenter
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stated that this reference to 9 CFR
71.10(a) may be inappropriate as
cresylic disinfectants, liquefied phenol,
chlorinated lime, and sodium hydroxide
are not present as active ingredients on
the labels of any current registered AI
virus disinfectant, nor is there any
exemption present to use Environmental
Protection Agency (EPA)-registered
tuberculocidal disinfectants against AI
virus. The commenter stated further that
there is no recommendation to use any
of the approximately 100 EPA-registered
AI virus disinfectants as per label
instructions or a disinfectant approved
by the EPA for use under a Federal
Insecticide, Rodenticide, and Fungicide
Act (FIFRA) section 18 exemption.
We agree with the commenter, and we
have amended the regulations to refer to
a disinfectant registered with the EPA
for AI virus per label instructions or a
disinfectant approved by the EPA for
use under a FIFRA section 18
exemption, instead of referring to a
disinfectant authorized by § 71.10(a).
The commenter also stated that there
is no guidance on how to disinfect
surfaces that are prevalent in poultry
houses but are not considered as
nonporous, e.g., cement, concrete,
wood, clay, etc., as there are no EPAregistered disinfectants and there is no
authorization from EPA to treat surfaces
that are not considered nonporous with
disinfectant.
We would not use a disinfectant on
any surface on which its use is not
authorized by its EPA label. We have
added text to paragraph (d)(2)(iii) of
§ 56.5 to clarify this issue. Given the
diversity of construction in commercial
poultry houses, disinfection of surfaces
considered to be nonporous will need to
be addressed in each individual State’s
initial State response and containment
plan, rather than in the guidelines in
paragraph (d).
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Conditions For Payment to Contractors
In the regulations established by the
interim rule, § 56.8 provides that when
poultry or eggs have been destroyed
pursuant to part 56, the Administrator
may pay claims to any party with which
the owner of the poultry or eggs has
entered into a contract for the growing
or care of the poultry or eggs. Section
56.8 also sets out a formula for
calculating the proportion of indemnity
paid to the owner of poultry or eggs
destroyed under part 56 that may be
paid to the contract grower:
∑ The value of the contract the owner
of the poultry or eggs entered into with
another party for the growing or care of
the poultry or eggs in dollars is divided
by the duration of the contract as it was
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signed prior to the H5/H7 LPAI outbreak
in days.
∑ This figure is multiplied by the time
in days between the date the other party
began to provide services relating to the
destroyed poultry or eggs under the
contract and the date the birds were
destroyed due to H5/H7 LPAI.
If compensation is paid to a grower
under § 56.8, the owner of the poultry
or eggs will be eligible to receive the
difference between the indemnity paid
to the growers and the total amount of
indemnity that may be paid for the
poultry or eggs.
These regulations work well for the
contract grower model prevalent in the
meat-type poultry industry, where
contract growers are typically paid on
delivery of the poultry and in which the
poultry increase in value over time until
they are ready for sale in the market.
However, since the publication of the
interim rule, we reviewed these
provisions and found that they are less
suitable for contract growers
maintaining egg-laying birds (table-egg
layers and breeding poultry). Such
growers are typically compensated at set
intervals during the contract (either
weekly or monthly). Under the
regulations as established by the interim
rule, growers could receive payment for
their labor both from the owner and
from APHIS if poultry in their care were
destroyed due to infection with or
exposure to H5/H7 LPAI after growers
had already received a payment from
the poultry owner.
Therefore, in this final rule, we are
adding a provision to the regulations in
§ 56.8 indicating that if a contract
grower receiving indemnity under § 56.8
has received any payment under his or
her contract from the owner of the
poultry at the time the poultry are
destroyed, the amount of indemnity for
which the contract grower is eligible
will be reduced by the amount of the
payment the contract grower has already
received.
Miscellaneous Changes
The interim rule stated that the
information collection and
recordkeeping requirements included in
the interim rule had been submitted for
emergency approval to the Office of
Management and Budget (OMB). Since
the publication of the interim rule, we
received approval for those information
collection and recordkeeping
requirements, as well as a paperwork
control number for those requirements.
The OMB control number for the
information collection associated with
this rule is 0579-0007. In this final rule,
we are adding the paperwork control
number to the sections of the
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10655
regulations established by the interim
rule that contain information collection
and recordkeeping requirements. These
sections are §§ 56.4, 56.6, 56.7, 56.9,
146.4, 146.11, 146.13, 146.14, 146.24,
and 146.44.
We are also making minor,
nonsubstantive corrections and changes.
Therefore, for the reasons given in the
interim rule and in this document, we
are adopting the interim rule as a final
rule, with the changes discussed in this
document.
This final rule also affirms the
information contained in the interim
rule concerning Executive Order 12372.
Effective Date
Pursuant to the administrative
procedure provisions in 5 U.S.C. 553,
we find good cause for making this rule
effective less than 30 days after
publication in the Federal Register. The
interim rule adopted as final by this rule
became effective on September 26, 2006.
This rule amends the interim rule to
provide that the amount of indemnity
for which contract growers are eligible
will be reduced by any payment they
have already received on their contracts
when poultry in their care are
destroyed, to clarify the roles of
cooperating State agencies with respect
to H5/H7 low pathogenic avian
influenza outbreaks, to provide that the
welfare of poultry to be destroyed will
be considered when selecting a method
for the destruction of poultry, and to
provide additional guidance for
cleaning and disinfecting an affected
premises in the interim rule. Immediate
action is necessary to make these
changes in order to help ensure that the
H5/H7 subtypes of low pathogenic avian
influenza are detected and eradicated
when they occur within the United
States. Therefore, the Administrator of
the Animal and Plant Health Inspection
Service has determined that this rule
should be effective upon publication in
the Federal Register.
Executive Order 12866 and Regulatory
Flexibility Act
This final rule has been determined to
be significant for the purposes of
Executive Order 12866 and, therefore,
has been reviewed by the Office of
Management and Budget.
In accordance with 5 U.S.C. 604, we
have performed a final regulatory
flexibility analysis, which is
summarized below, regarding the
economic effects of this rule on small
entities. Copies of the full analysis are
available on the Regulations.gov Web
site (see footnote 1 in this document for
a link to Regulations.gov) or by
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contacting the person listed under FOR
FURTHER INFORMATION CONTACT.
Under the interim rule, the USDA
established a voluntary control program
for H5/H7 LPAI. As part of the program,
participating owners and growers are
indemnified for losses arising from
depopulation of birds affected with H5/
H7 LPAI.
In general, benefits of containing the
spread of a livestock or poultry disease
fall into three categories: 1) Avoided
producer losses from disease morbidity
and mortality; 2) avoided consumer
losses due to price increases resulting
from decreased supplies (net of avoided
gains to producers attributable to the
price increases); and 3) avoided reduced
demand if markets are closed to affected
commodities. LPAI is rarely fatal to
infected birds. However, the longer an
outbreak is not controlled, with more
birds becoming infected with H5/H7
LPAI, the more likely it is that the virus
may mutate into a highly pathogenic
form. The more timely and wellplanned the response to an LPAI
occurrence, the less likely it will result
in harmful price and trade effects. This
final rule has the objectives of reducing
the risk of H5/H7 LPAI outbreaks and
improving responsiveness and
eradication measures at the grower,
industry, and State levels when the
disease does occur.
The groups who enjoy the primary
benefit of a disease eradication
campaign are consumers and those
owners/growers whose flocks have
remained healthy. Owners and growers
of the depopulated flocks bear the
primary burden of an eradication effort,
if not indemnified. In addition to the
value of lost production, the owners/
growers of affected birds may also bear
costs of cleanup, disinfection,
transportation, forgone income, and
other financial hardships. The benefits
of a voluntary avian influenza control
program derive from disease prevention
and from cost minimization when an
outbreak does occur. Evidence of the
types of benefits gained from control of
avian influenza is found in a USDAEconomic Research Service study of a
1983-84 outbreak.4 A 2002 outbreak in
Virginia also exemplifies the types of
costs incurred due to an avian influenza
incident. While these occurrences show
that the costs of an avian influenza
outbreak can be substantial, recent
outbreaks have typically been smaller in
scale. An ongoing surveillance program
4 Lasley, F. A., Short, S. D., and Henson, W. L.
1985. Economic Assessment of the 1983-84 Avian
Influenza Eradication Program. USDA, ERS,
National Economics Division.
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contributes to our ability to detect
outbreaks early and limit their effects.
To the extent that the final rule
contributes to the elimination of AI, all
affected entities should benefit over the
long term. The program that APHIS is
establishing is a voluntary program;
producers are not required to
participate. The benefits of this rule,
from preventing LPAI outbreaks and
minimizing losses should an outbreak
occur, are expected to exceed costs to
producers and States of participating in
the program’s disease prevention efforts.
Under the rule, producers will be
required to keep flocks and facilities
clean, slaughter plants will be required
to conduct sampling, and States will be
required to conduct annual inspections
and develop response and containment
plans. APHIS will provide full
indemnities for specific costs to
participating producers and States
should an outbreak occur.
The final rule explicitly provides
indemnity for cleaning and disinfection
in the case of birds moved for controlled
marketing. Since the interim rule was
implemented, APHIS has paid these
costs on a few occasions. These costs
vary widely. The variations may be
attributed to factors such as the type of
production, where the operation is
located, the size of the operation, the
company involved in the cleaning and
disinfection, as well as other factors.
Executive Order 12988
This final rule has been reviewed
under Executive Order 12988, Civil
Justice Reform. This rule: (1) Has no
retroactive effect; and (2) does not
require administrative proceedings
before parties may file suit in court
challenging this rule.
Paperwork Reduction Act
In accordance with the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501 et
seq.), the information collection or
recordkeeping requirements included in
the interim rule have been approved by
the Office of Management and Budget
(OMB) under OMB control number
0579–0007.
E-Government Act Compliance
The Animal and Plant Health
Inspection Service is committed to
compliance with the E–Government Act
to promote the use of the Internet and
other information technologies, to
provide increased opportunities for
citizen access to Government
information and services, and for other
purposes. For information pertinent to
E-Government Act compliance related
to this rule, please contact Mrs. Celeste
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Sickles, APHIS’ Information Collection
Coordinator, at (301) 851-2908.
List of Subjects
9 CFR Part 56
Animal diseases, Indemnity
payments, Low pathogenic avian
influenza, Poultry.
9 CFR Part 146
Animal diseases, Poultry and poultry
products, Reporting and recordkeeping
requirements.
■ Accordingly, the interim rule
amending 9 CFR parts 53, 56, 145, 146,
and 147 that was published at 71 FR
53601-56333 on September 26, 2006, is
adopted as a final rule with the
following changes:
PART 56—CONTROL OF H5/H7 LOW
PATHOGENIC AVIAN INFLUENZA
1. The authority citation for part 56
continues to read as follows:
■
Authority: 7 U.S.C. 8301-8317; 7 CFR 2.22,
2.80, and 371.4.
2. Section 56.1 is amended by revising
the definition of H5/H7 LPAI virus
infection (infected) to read as follows:
■
§ 56.1
Definitions.
*
*
*
*
*
H5/H7 LPAI virus infection (infected).
(1) Poultry will be considered to be
infected with H5/H7 LPAI for the
purposes of this part if:
(i) H5/H7 LPAI virus has been
isolated and identified as such from
poultry; or
(ii) Viral antigen or viral RNA specific
to the H5 or H7 subtype of AI virus has
been detected in poultry; or
(iii) Antibodies to the H5 or H7
subtype of the AI virus that are not a
consequence of vaccination have been
detected in poultry. If vaccine is used,
methods should be used to distinguish
vaccinated birds from birds that are both
vaccinated and infected. In the case of
isolated serological positive results, H5/
H7 LPAI infection may be ruled out on
the basis of a thorough epidemiological
investigation that does not demonstrate
further evidence of H5/H7 LPAI
infection, as determined by APHIS.
(2) The official determination that H5/
H7 LPAI virus has been isolated and
identified, viral antigen or viral RNA
specific to the H5 or H7 subtype of AI
virus has been detected, or antibodies to
the H5 or H7 subtype of AI virus have
been detected may only be made by the
National Veterinary Services
Laboratories.
*
*
*
*
*
§ 56.2
■
[Amended]
3. Section 56.2 is amended as follows:
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a. In paragraphs (a)(2) and (a)(3), by
removing the words ‘‘developed by the
Official State Agency and’’ each time
they occur.
■ b. In paragraph (a)(3), by adding a
period at the end of the paragraph.
■ c. In paragraph (c), by removing the
word ‘‘States’’ and adding the words
‘‘Cooperating State Agencies’’ in its
place.
■ 4. Section 56.3 is amended by revising
paragraph (b)(7) to read as follows:
■
§ 56.3
Payment of indemnity.
*
*
*
*
*
(b) * * *
(7) The poultry are located in a State
that does not participate in the
diagnostic surveillance program for H5/
H7 LPAI, as described in § 146.14 of this
chapter, or that does not have an initial
State response and containment plan for
H5/H7 LPAI that is approved by APHIS
under § 56.10, unless such poultry
participate in the Plan with another
State that does participate in the
diagnostic surveillance program for H5/
H7 LPAI, as described in § 146.14 of this
chapter, and has an initial State
response and containment plan for H5/
H7 LPAI that is approved by APHIS
under § 56.10.
*
*
*
*
*
■ 5. Section 56.4 is amended as follows:
■ a. In paragraph (a)(2), in the second
and third sentences, by removing the
word ‘‘compensation’’ and adding the
word ‘‘indemnity’’ in its place.
■ b. In paragraph (c)(2), by adding two
new sentences after the third sentence
to read as set forth below.
■ c. By adding the OMB citation
‘‘(Approved by the Office of
Management and Budget under control
number 0579-0007)’’ at the end of the
section.
§ 56.4 Determination of indemnity
amounts.
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*
*
*
*
*
(c) * * *
(2) * * *Appraisals of materials
must be reported on forms furnished by
APHIS and signed by the appraisers and
must be signed by the owners of the
materials to indicate agreement with the
appraisal amount. Appraisals of
materials must be signed prior to the
destruction of the materials, unless the
owners, APHIS, and the Cooperating
State Agency agree that the materials
may be destroyed immediately. * * *
■ 6. Section 56.5 is amended as follows:
■ a. In paragraph (a)(7), by removing the
word ‘‘and’’ at the end of the paragraph.
■ b. In paragraph (a)(8), by removing the
period and adding the word ‘‘; and’’ in
its place.
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c. By adding a new paragraph (a)(9) to
read as set forth below.
■ d. By revising paragraph (c)(2) to read
as set forth below.
■ e. In the introductory text of
paragraph (d), by adding a new sentence
before the last sentence to read as set
forth below.
■ f. By revising paragraphs (d)(1)(iii),
(d)(2)(ii), and (d)(2)(iii) to read as set
forth below.
■ g. In paragraph (d)(2)(i), by removing
the word ‘‘washed’’ each time it occurs
and adding the word ‘‘cleaned’’ in its
place.
■
§ 56.5 Destruction and disposal of poultry
and cleaning and disinfection of premises,
conveyances, and materials.
(a) * * *
(9) Consistency of the method with
humane euthanasia guidelines.
*
*
*
*
*
(c) * * *
(2) Poultry moved for controlled
marketing will not be eligible for
indemnity under § 56.3. However, any
costs related to cleaning and
disinfection of premises, conveyances,
and materials that came into contact
with poultry that are moved for
controlled marketing will be eligible for
indemnity under § 56.3.
(d) * * *Cleaning and disinfection
must also be performed in accordance
with any applicable State and local
environmental regulations. * * *
(1) * * *
(iii) Close the house in which the
poultry were held, maintaining just
enough ventilation to remove moisture.
Heat the house to 100 °F and begin inhouse composting. Leave the house
undisturbed for a minimum of 21 days
and for as long as possible thereafter, in
order to allow as much H5/H7 LPAI
virus as possible to die a natural death.
*
*
*
*
*
(2) * * *
(ii) Cleaning of premises and
materials. Cleaning and washing should
be thorough to ensure that all materials
or substances contaminated with H5/H7
LPAI virus, especially manure, dried
blood, and other organic materials, are
removed from all surfaces. Spray all
contaminated surfaces above the floor
with detergent and water to knock dust
down to the floor, using no more water
than necessary. Wash equipment and
houses with detergent and water.
Disassemble equipment as required to
clean all contaminated surfaces. Special
attention should be given to automatic
feeders and other closed areas to ensure
adequate cleaning. Inspect houses and
equipment to ensure that cleaning has
removed all contaminated materials or
substances. Rinse with fresh water and
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10657
let houses and equipment dry
completely before applying disinfectant.
(iii) Disinfection of premises and
materials. When cleaning has been
completed and all surfaces are dry, all
interior surfaces of the structure should
be saturated with a disinfectant
registered with the U.S. Environmental
Protection Agency (EPA) for AI virus
per label instructions or a disinfectant
approved by the EPA for use under a
Federal Insecticide, Rodenticide, and
Fungicide Act section 18 exemption. A
power spray unit should be used to
spray the disinfectant on all surfaces
that may be treated with the disinfectant
according to its EPA label, making sure
that the disinfectant gets into cracks and
crevices. Special attention should be
given to automatic feeders and other
closed areas to ensure adequate
disinfection.
*
*
*
*
*
§ 56.6
[Amended]
7. Section 56.6 is amended by adding
the OMB citation ‘‘(Approved by the
Office of Management and Budget under
control number 0579-0007)’’ at the end
of the section.
■
§ 56.7
[Amended]
8. Section 56.7 is amended by adding
the OMB citation ‘‘(Approved by the
Office of Management and Budget under
control number 0579-0007)’’ at the end
of the section.
■
9. Section 56.8 is amended as follows:
a. In paragraph (a)(2), by removing the
word ‘‘birds’’ and adding the words
‘‘poultry or eggs’’ in its place.
■ b. By redesignating paragraphs (c) and
(d) as paragraphs (d) and (e),
respectively, and adding a new
paragraph (c) to read as set forth below.
■
■
§ 56.8
Conditions for payment.
*
*
*
*
*
(c) If a contractor receiving indemnity
under this section has received any
payment under his or her contract from
the owner of the poultry or eggs at the
time the poultry or eggs are destroyed,
the amount of indemnity for which the
contract grower is eligible will be
reduced by the amount of the payment
the contract grower has already
received.
*
*
*
*
*
§ 56.9
[Amended]
10. Section 56.9 is amended by adding
the OMB citation ‘‘(Approved by the
Office of Management and Budget under
control number 0579-0007)’’ at the end
of the section.
■
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Federal Register / Vol. 75, No. 45 / Tuesday, March 9, 2010 / Rules and Regulations
11. In § 56.10, the introductory text of
paragraph (a) is revised to read as
follows:
■
§ 56.10 Initial State response and
containment plan.
(a) In order for poultry owners within
a State to be eligible for indemnity for
100 percent of eligible costs under
§ 56.3(b), the State in which the poultry
participate in the Plan must have in
place an initial State response and
containment plan that has been
approved by APHIS. The initial State
response and containment plan must be
developed by the Official State Agency.
In States where the Official State
Agency is different than the Cooperating
State Agency, the Cooperating State
Agency must also participate in the
development of the plan. The plan must
be administered by the Cooperating
State Agency of the relevant State. This
plan must include:
*
*
*
*
*
PART 146—NATIONAL POULTRY
IMPROVEMENT PLAN FOR
COMMERCIAL POULTRY
12. The authority citation for part 146
continues to read as follows:
■
Authority: 7 U.S.C. 8301-8317; 7 CFR 2.22,
2.80, and 371.4.
the basis of a thorough epidemiological
investigation that does not demonstrate
further evidence of H5/H7 LPAI
infection, as determined by APHIS.
(2) The official determination that H5/
H7 LPAI virus has been isolated and
identified, viral antigen or viral RNA
specific to the H5 or H7 subtype of AI
virus has been detected, or antibodies to
the H5 or H7 subtype of AI virus have
been detected may only be made by the
National Veterinary Services
Laboratories.
*
*
*
*
*
§ 146.2
14. In § 146.2, paragraph (f) is
amended by removing the word ‘‘States’’
and adding the words ‘‘Cooperating
State Agencies’’ in its place.
■
§ 146.4
[Amended]
15. Section 146.4 is amended by
adding the OMB citation ‘‘(Approved by
the Office of Management and Budget
under control number 0579-0007)’’ at
the end of the section.
■
§ 146.11
[Amended]
16. Section 146.11 is amended by
adding the OMB citation ‘‘(Approved by
the Office of Management and Budget
under control number 0579-0007)’’ at
the end of the section.
■
13. In § 146.1, a new definition of
Cooperating State Agency is added and
the definition of H5/H7 LPAI virus
infection (infected) is revised to read as
follows:
§ 146.13
§ 146.1
■
■
Definitions.
*
sroberts on DSKD5P82C1PROD with RULES
[Amended]
*
*
*
*
Cooperating State Agency. Any State
authority recognized by the Department
to cooperate in the administration of the
provisions of part 56 of this chapter.
This may include the State animal
health authority or the Official State
Agency.
*
*
*
*
*
H5/H7 LPAI virus infection (infected).
(1) Poultry will be considered to be
infected with H5/H7 LPAI for the
purposes of this part if:
(i) H5/H7 LPAI virus has been
isolated and identified as such from
poultry; or
(ii) Viral antigen or viral RNA specific
to the H5 or H7 subtype of AI virus has
been detected in poultry; or
(iii) Antibodies to the H5 or H7
subtype of the AI virus that are not a
consequence of vaccination have been
detected in poultry. If vaccine is used,
methods should be used to distinguish
vaccinated birds from birds that are both
vaccinated and infected. In the case of
isolated serological positive results, H5/
H7 LPAI infection may be ruled out on
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[Amended]
17. Section 146.13 is amended by
adding the OMB citation ‘‘(Approved by
the Office of Management and Budget
under control number 0579-0007)’’ at
the end of the section.
§ 146.14
[Amended]
18. Section 146.14 is amended by
adding the OMB citation ‘‘(Approved by
the Office of Management and Budget
under control number 0579-0007)’’ at
the end of the section.
■
§ 146.24
[Amended]
19. Section 146.24 is amended by
adding the OMB citation ‘‘(Approved by
the Office of Management and Budget
under control number 0579-0007)’’ at
the end of the section.
■
§ 146.44
[Amended]
20. Section 146.44 is amended by
adding the OMB citation ‘‘(Approved by
the Office of Management and Budget
under control number 0579-0007)’’ at
the end of the section.
■
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Done in Washington, DC, this 1st day
of March 2010.
John Ferrell,
Deputy Under Secretary for Marketing and
Regulatory Programs.
[FR Doc. 2010–4874 Filed 3–8–10; 8:45 am]
BILLING CODE 3410–34–S
DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
14 CFR Part 39
[Docket No. FAA–2009–0452; Directorate
Identifier 2007–NM–326–AD; Amendment
39–16223; AD 2010–05–13]
RIN 2120–AA64
Airworthiness Directives; The Boeing
Company Model 737–100, –200, –200C,
–300, –400, and –500 Series Airplanes
AGENCY: Federal Aviation
Administration (FAA), Department of
Transportation (DOT).
ACTION: Final rule.
SUMMARY: The FAA is superseding an
existing airworthiness directive (AD)
that applies to all Model 737–100, –200,
–200C, –300, –400, and –500 series
airplanes. That AD currently requires a
one-time inspection for scribe lines and
cracks in the fuselage skin at certain lap
joints, butt joints, external repair
doublers, and other areas; and related
investigative/corrective actions if
necessary. This new AD expands the
area to be inspected and, for certain
airplanes, requires earlier inspections
for certain inspection zones. This AD
results from additional detailed analysis
of fuselage skin cracks adjacent to the
skin lap joints on airplanes that had
scribe lines. The analysis resulted in
different inspection zones, thresholds
and repetitive intervals, and airplane
groupings. We are issuing this AD to
prevent rapid decompression of the
airplane due to fatigue cracks resulting
from scribe lines on pressurized
fuselage structure.
DATES: This AD becomes effective April
13, 2010.
The Director of the Federal Register
approved the incorporation by reference
of a certain publication listed in the AD
as of April 13, 2010.
ADDRESSES: For service information
identified in this AD, contact Boeing
Commercial Airplanes, Attention: Data
& Services Management, P.O. Box 3707,
MC 2H–65, Seattle, Washington 98124–
2207; telephone 206–544–5000,
extension 1; fax 206–766–5680; e-mail
me.boecom@boeing.com; Internet
https://www.myboeingfleet.com.
E:\FR\FM\09MRR1.SGM
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Agencies
[Federal Register Volume 75, Number 45 (Tuesday, March 9, 2010)]
[Rules and Regulations]
[Pages 10645-10658]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-4874]
[[Page 10645]]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
9 CFR Parts 53, 56, 145, 146, and 147
[Docket No. APHIS-2005-0109]
RIN 0579-AB99
Low Pathogenic Avian Influenza; Voluntary Control Program and
Payment of Indemnity
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: We are adopting as a final rule, with changes, an interim rule
that amended the regulations by establishing, under the auspices of the
National Poultry Improvement Plan, a voluntary program for the control
of the H5/H7 subtypes of low pathogenic avian influenza in commercial
poultry. As amended by this document, the rule provides that the amount
of indemnity for which contract growers are eligible will be reduced by
any payment they have already received on their contracts when poultry
in their care are destroyed, clarifies the roles of cooperating State
agencies with respect to H5/H7 low pathogenic avian influenza
outbreaks, provides that consistency with humane euthanasia guidelines
will be considered when selecting a method for the destruction of
poultry, and provides additional guidance for cleaning and disinfecting
an affected premises. The control program and indemnity provisions
established by the interim rule are necessary to help ensure that the
H5/H7 subtypes of low pathogenic avian influenza are detected and
eradicated when they occur within the United States.
EFFECTIVE DATE: March 9, 2010.
FOR FURTHER INFORMATION CONTACT: Mr. Andrew R. Rhorer, Senior
Coordinator, Poultry Improvement Staff, National Poultry Improvement
Plan, Veterinary Services, APHIS, USDA, 1498 Klondike Road, Suite 101,
Conyers, GA 30094-5104; (770) 922-3496.
SUPPLEMENTARY INFORMATION:
Background
The National Poultry Improvement Plan (NPIP, also referred to below
as ``the Plan'') is a cooperative Federal-State-industry mechanism for
controlling certain poultry diseases. The Plan consists of a variety of
programs intended to prevent and control poultry diseases.
Participation in all Plan programs is voluntary, but breeding flocks,
hatcheries, and dealers must first qualify as ``U.S. Pullorum-Typhoid
Clean'' as a condition for participating in the other Plan programs.
The Plan identifies States, flocks, hatcheries, dealers, and
slaughter plants that meet certain disease control standards specified
in the Plan's various programs. As a result, customers can buy poultry
that has tested clean of certain diseases or that has been produced
under disease-prevention conditions. The regulations in 9 CFR parts
145, 146, and 147 (referred to below as the regulations) contain the
provisions of the Plan.
In an interim rule\1\ effective and published in the Federal
Register on September 26, 2006 (71 FR 53601-56333, Docket No. APHIS-
2005-0109), we amended the regulations to establish a voluntary control
program for the H5/H7 subtypes of low pathogenic avian influenza (H5/H7
LPAI) in commercial poultry--specifically, in table-egg layers, meat-
type chickens, and meat-type turkeys. The provisions of this program
were established in a new part 146. The interim rule also established a
new part 56, titled ``Control of H5/H7 Low Pathogenic Avian
Influenza,'' in 9 CFR chapter I, subchapter B, to provide for the
payment of indemnity for costs associated with the eradication of H5/H7
LPAI.
---------------------------------------------------------------------------
\1\ To view the interim rule and the comments we received, go to
(https://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=APHIS-2005-0109).
---------------------------------------------------------------------------
We solicited comments on the interim rule for 60 days ending
November 27, 2006. We received 11 comments by the due date. They were
from State governments, industry associations, advocacy groups, and
private citizens. We have carefully considered all of the comments we
received. They are discussed below by topic.
General Comments
One commenter stated that the conditions under which commercial
poultry are produced cause disease, and that the U.S. Department of
Agriculture (USDA) should prohibit current poultry production
practices.
We do not agree with the commenter's recommendation and do not
believe it is necessary or appropriate to consider such regulation of
poultry production practices in this rulemaking. H5/H7 LPAI is caused
by a virus. The interim rule provided for surveillance programs and
emergency response provisions to detect and eradicate the virus.
The ``Background'' section of the interim rule stated that there
are 15 recognized hemagglutinin (H) subtypes of avian influenza (AI).
One commenter stated that there are 16 such subtypes.
The commenter is correct. Since the regulations do not refer to the
number of hemagglutinin subtypes, no change in the regulations
established by the interim rule is necessary.
The ``Background'' section also stated the following: ``Diagnostic
surveillance [for AI in the United States] is conducted through
industry, State, and university diagnostic laboratories. These
laboratories routinely test for AI, both serologically and by virus
isolation, whenever birds are submitted from a flock with clinical
signs compatible with HPAI or LPAI.'' One commenter suggested that this
statement should refer to testing for AI by serology, antigen
detection, and/or virus isolation, because serology cannot be performed
on dead birds.
We agree with the commenter. Diagnostic surveillance laboratories
in the United States use whatever means are appropriate to test poultry
for AI. This comment does not necessitate a change in the regulations
established by the interim rule.
On the subject of surveillance for AI, the interim rule stated that
Texas established a surveillance program for commercial poultry flocks
near the Mexican border following the Mexican HPAI outbreak in 1994-95.
One commenter suggested deleting the words ``near the Mexican border''
from this statement.
We agree; the program in Texas was Statewide. This comment does not
necessitate a change in the regulations established by the interim
rule.
The interim rule established the new part 146 for table-egg layers,
meat-type chickens, and meat-type turkeys as the NPIP regulations for
commercial poultry. One commenter suggested that we amend the NPIP
regulations for breeding poultry in 9 CFR part 145 to refer to
``commercial breeding flocks'' and ``commercial breeding poultry.''
We have determined that such a change would be inappropriate. The
regulations established by the interim rule use the term ``commercial''
to refer to large-scale operations producing poultry for meat or eggs
for consumption. The commenter apparently intends that the term
``commercial'' be used to refer to any large-scale operation. This
could create confusion, since the poultry regulated in 9 CFR part 146
would not be clearly distinct from the poultry regulated in part 145.
In addition, using the term ``commercial'' to refer to the poultry
covered by 9 CFR part 145 would be inaccurate, as the breeders who
participate in the Plan under subpart E
[[Page 10646]]
of part 145, which covers waterfowl, exhibition poultry, and game bird
breeding flocks and products, typically are hobbyist breeders rather
than large-scale breeders. We are making no changes in response to this
comment.
Auditing
In the regulations established by the interim rule, Sec. 146.11
provides for inspection of participating flocks and slaughter plants.
Paragraph (a) of Sec. 146.11 requires each participating slaughter
plant to be audited at least once annually or a sufficient number of
times each year to satisfy the Official State Agency that the
participating slaughter plant is in compliance with the provisions of 9
CFR part 146.
One commenter stated that this language implies but does not
specifically state that the Official State Agency will both audit and
determine compliance. If we do not envision any potential conflict of
interest and the inference is correct, the commenter recommended
amending the text to clarify. The commenter suggested using the
following text: ``Each participating slaughter plant shall be audited
at least once annually by the head of the Official State Agency or a
sufficient number of times each year to satisfy him/her self that the
participating slaughter plant is in compliance with the provisions of
this part.''
Our intention in Sec. 146.11(a) was to refer to audits of records
of testing, and the results of that testing, that are kept by the
slaughter plant, rather than to any audit of the slaughter plant
facility itself. Audits by the Official State Agency of testing records
should not create any conflict of interest; this process is also used
in the NPIP regulations in 9 CFR part 145.
In a final rule published in the Federal Register on April 1, 2009
(74 FR 14710-14719, Docket No. APHIS-2007-0042), and effective on May
1, 2009, we amended Sec. 146.11 so that it refers specifically to
auditing testing records and provides additional detail about the
auditing process. We believe these changes addressed the commenter's
concerns, and we are making no further changes to the auditing
provisions in Sec. 146.11 in this final rule.
Testing
In the regulations established by the interim rule, Sec. 146.13
sets out requirements for testing Plan flocks for AI. Paragraph (b)(1)
of Sec. 146.13 provides that any samples that are found to be positive
by the agar gel immunodiffusion test must be further tested and
subtyped by Federal Reference Laboratories using the hemagglutination
inhibition test.
One commenter asked that we include a list in the regulations of
laboratories that are Federal Reference Laboratories.
The regulations for testing for AI in breeding poultry, in Sec.
145.14(d), also refer to further testing and subtyping by Federal
Reference Laboratories. Currently, the only Federal Reference
Laboratory for AI is the National Veterinary Services Laboratories
(NVSL) in Ames, IA. In response to this comment, we will post a list of
Federal Reference Laboratories on the NPIP Web site, at (https://www.aphis.usda.gov/animal_health/animal_dis_spec/poultry/index.shtml).
Diagnostic Surveillance Program
In the regulations established by the interim rule, Sec. 146.14
requires all States participating in the Plan for commercial poultry to
develop a diagnostic surveillance program for all poultry, not just
commercial poultry, in that State. The diagnostic surveillance program
is one of the three components that were identified as key to the H5/H7
LPAI program at a meeting APHIS organized with State and industry
representatives that took place in May 2002 in San Antonio, TX.
The exact provisions of the program are at the discretion of the
States, but under the program, AI must be a disease reportable to the
responsible State authority (State veterinarian, etc.) by all licensed
veterinarians. To accomplish this, all laboratories (private, State,
and university laboratories) that perform diagnostic procedures on
poultry must examine all submitted cases of unexplained respiratory
disease, egg production drops, and mortality for AI by both an approved
serological test and an approved antigen detection test.
Memoranda of understanding or other means must be used to establish
testing and reporting criteria (including criteria that provide for
reporting H5 and H7 LPAI directly to the Service) and approved testing
methods. In addition, States should conduct outreach to poultry
producers, especially owners of smaller flocks, regarding the
importance of prompt reporting of clinical symptoms consistent with AI.
One commenter had a specific concern with requiring all
laboratories (private, State, and university laboratories) that perform
diagnostic procedures on poultry to examine all submitted cases of
unexplained respiratory disease, egg production drops, and mortality
for AI by both an approved serological test and an approved antigen
detection test. The commenter stated that this requirement should apply
only to commercial poultry. Such a change is necessary, the commenter
stated, because owner consent is critical for diagnostic laboratories
and, in the commenter's State, laboratories that perform tests must
also charge fees.
It is true that some poultry owners may have to bear the burden of
additional testing costs associated with the diagnostic surveillance
program's testing requirements. Although some States do not impose
charges for such testing, many States do. However, producers smaller
than the size standards established in 9 CFR part 146 are only required
to participate in the diagnostic surveillance program, which means
testing for AI is only required for submitted cases of unexplained
respiratory disease, egg production drops, and mortality.
The diagnostic surveillance program is a key component of the H5/H7
LPAI program because it allows surveillance to reach all sectors of the
poultry industry. In addition, the index case in an outbreak will
likely be detected through the diagnostic surveillance program, since
it focuses on sick poultry. Detecting H5/H7 LPAI quickly will expedite
the response and control or eradication of H5/H7 LPAI before they have
the chance to mutate to highly pathogenic strains of AI. Therefore, it
is crucial to the success of the H5/H7 LPAI program to have the
diagnostic surveillance program apply to all poultry. We are making no
changes to the regulations established by the interim rule in response
to this comment.
Surveillance of Live Bird Markets and Pet Birds
As noted earlier, the voluntary control program established by the
interim rule requires diagnostic surveillance for all poultry in
participating States. It also requires active surveillance for
participating commercial flocks and slaughter plants over certain size
thresholds, but does not include requirements for active surveillance
for other flocks and slaughter plants. In the ``Background'' section of
the interim rule, we briefly discussed the active surveillance that we
carry out in live bird markets, noting that APHIS has entered into
cooperative agreements with States that have live bird market
activities, as well as Official State Agencies and NPIP authorized
laboratories participating in the NPIP LPAI program.
One commenter stated that, while increased surveillance activities
at live bird markets lower the risk of AI transmission, continued
outbreaks of
[[Page 10647]]
the disease indicate that this approach is inadequate. The commenter
encouraged APHIS to take a further step and permanently prohibit the
sale and slaughter of birds at public markets. In the commenter's view,
this action would not only provide for disease control but would
benefit animal welfare, as the commenter stated that animals in these
markets are frequently held and killed in an inhumane manner.
If the sale of live birds at public markets is not to be
prohibited, the commenter recommended that: 1) Surveillance be
increased, 2) housing and welfare conditions be included in the
auditing of markets, and 3) no producers be compensated in any way for
birds killed for disease control purposes at these high-risk venues.
We are confident that the surveillance mechanisms we have developed
in cooperation with States are sufficient to detect any H5/H7 LPAI
present in the markets and to allow us to address the disease
expeditiously. We do not believe it is necessary to prohibit the sale
of poultry at live bird markets where there are appropriate
surveillance mechanisms and related disease safeguards available.
With regard to the commenter's recommendations, we have determined
that current levels of surveillance are adequate to detect outbreaks of
H5/H7 LPAI in live bird markets. While our audits of markets relate
only to the prevention of the introduction or spread of disease, live
bird markets must comply with all laws and regulations applicable to
their operation, including any applicable State animal welfare laws and
regulations; we would report circumstances that we know to be
violations of such laws and regulations to State authorities. Finally,
if a person has complied with all applicable regulations and agreements
pertaining to surveillance and biosecurity for H5/H7 LPAI at a live
bird market, it would be inappropriate to declare that person
ineligible for indemnity, as that person would have incurred costs
eligible for indemnity while complying with the regulations. In
addition, denying indemnity as the commenter suggests would establish a
negative incentive for reporting potential H5/H7 LPAI infection, thus
potentially leading to late reporting of H5/H7 LPAI outbreaks and
hampering our surveillance efforts. We are making no changes in
response to this comment.
This commenter also asked us to regulate the sale of birds in the
retail pet industry. At pet stores, the commenter stated, exotic birds
from many different geographical locations are mixed together and are
often housed in close proximity to domestic fowl in retail pet shops.
The commenter believes there are inadequate licensing, regulatory
oversight, and recordkeeping requirements to track birds sold in pet
shops, and, as a result, APHIS is missing the chance to detect disease
early, and control, if not prevent, its spread.
We expect that, under the regulations in 9 CFR parts 56 and 146,
any outbreaks of H5/H7 LPAI in commercial poultry would be confined to
the premises on which they occur. Our regulations governing the
importation of pet birds in 9 CFR part 93 are sufficient to prevent the
introduction of LPAI via the importation of pet birds. If H5/H7 LPAI
were to spread to pet birds, these birds would be considered infected
with or exposed to H5/H7 LPAI under the regulations in 9 CFR part 56
and thus would be subject to the requirements of the relevant State's
initial response and containment plan for H5/H7 LPAI. These
restrictions on the interstate movement of pet birds are sufficient to
prevent the spread of H5/H7 LPAI.
State H5/H7 Avian Influenza Monitored Classifications
In the regulations established by the interim rule, subparts B
through D of 9 CFR part 146 provide special conditions for
participation in the Plan by commercial table-egg layer flocks,
commercial meat-type chicken slaughter plants, and commercial meat-type
turkey slaughter plants, respectively. Within subparts B and D,
Sec. Sec. 146.24 and 146.44 provide for U.S. H5/H7 Avian Influenza
Monitored State classifications for table-egg layers and meat-type
turkey slaughter plants; there is no U.S. H5/H7 Avian Influenza
Monitored State classification for meat-type chicken slaughter plants
in subpart C.
One commenter stated that it seems incongruous not to have a U.S.
H5/H7 Avian Influenza Monitored State status for meat-type chickens if
it is rational to have such a status for meat-type turkeys.
As we stated in the interim rule, in consultation with our State
and industry cooperators, we have determined that it is not necessary
to provide for a U.S. H5/H7 Avian Influenza Monitored State
classification for meat-type chickens at this time. The regulations for
meat-type chicken slaughter plants provide the same level of
surveillance as occurs at table-egg layer premises and meat-type turkey
slaughter plants, the diagnostic surveillance program required by the
regulations covers all poultry in the State, and the regulations in 9
CFR part 56, including the requirement for an initial State response
and containment plan for H5/H7 LPAI infections, are sufficient to
ensure that H5/H7 LPAI infections in meat-type chickens are handled
appropriately. We will continue to examine the issue, and if we
determine at some point in the future that it is useful to be able to
designate States as U.S. H5/H7 Avian Influenza Monitored, we will
implement such a classification.
In the regulations established by the interim rule, Sec. 56.10(b)
provides that if a State is designated a U.S. Avian Influenza Monitored
State, Layers under Sec. 146.24(a) or a U.S. Avian Influenza Monitored
State, Turkeys under Sec. 146.44(a), it will lose that status during
any outbreak of H5/H7 LPAI and for 90 days after the destruction and
disposal of all infected or exposed birds and cleaning and disinfection
of all affected premises are completed.
One commenter asked us to clarify what is meant by an outbreak, and
specifically whether the discovery of H5/H7 LPAI in a live bird market
would constitute an outbreak that would result in a State losing its
U.S. H5/H7 Avian Influenza Monitored State status.
Consistent with the World Organization on Animal Health (OIE)
guidelines for AI,\2\ we consider any outbreak of H5/H7 LPAI in
domesticated poultry to be an outbreak for the purposes of Sec.
56.10(b). This includes live bird markets. However, as indicated in
Sec. Sec. 146.24(a)(2) and 146.44(a)(2), a State will maintain its
U.S. H5/H7 Avian Influenza Monitored State status after a single
outbreak of H5/H7 LPAI as long as long as the State responds to the
outbreak in accordance with 9 CFR part 56, there are not repeated
outbreaks, and the outbreak does not spread beyond the originating
premises. If any of those circumstances did not occur, APHIS would have
grounds to revoke the State status, although APHIS would have to make a
thorough investigation and give the State an opportunity for a hearing
before doing so.
---------------------------------------------------------------------------
\2\ As found in the Terrestrial Animal Health Code. The
guidelines are available on the Internet at (https://www.oie.int/eng/normes/mcode/en_chapitre_1.10.4.htm).
---------------------------------------------------------------------------
Definition of H5/H7 LPAI Virus Infection (Infected)
The regulations established by the interim rule in Sec. Sec. 56.1
and 146.1 define H5/H7 LPAI virus infection (infected) by stating that
poultry will be considered to be infected with H5/H7 LPAI for the
purposes of parts 56 and 146 if:
H5/H7 LPAI virus has been isolated and identified as such
from poultry; or
Viral antigen or viral RNA specific to the H5 or H7
subtype of AI virus has been detected in poultry; or
[[Page 10648]]
Antibodies to the H5 or H7 subtype of the AI virus that
are not a consequence of vaccination have been detected in poultry. If
vaccine is used, methods should be used to distinguish vaccinated birds
from birds that are both vaccinated and infected. In the case of
isolated serological positive results, H5/H7 LPAI infection may be
ruled out on the basis of a thorough epidemiological investigation that
does not demonstrate further evidence of H5/H7 LPAI infection.
One commenter expressed concern about the last sentence of this
definition, which discusses using an epidemiological investigation to
determine that no further evidence of H5/H7 LPAI infection exists. The
commenter stated that this statement indicates that certain LPAI events
that leave evidence of prior infection (seropositivity) can be
discounted and may not require any response actions. If this is not the
intent of the definition, the commenter stated, we should remove this
statement from the regulations. If the statement is not removed, the
commenter recommended that comprehensible descriptions of the criteria
that must be met in order to discount serological evidence of infection
be added to the regulations. The commenter also recommended that the
entity responsible for making such determinations be specified.
Our definition in Sec. Sec. 56.1 and 146.1 is based on the
definition provided in the OIE guidelines for AI referred to in this
document. We believe it is appropriate to include the provision that
allows for ruling out H5/H7 LPAI infection on the basis of a thorough
epidemiological investigation. It would be impractical to specify
criteria for ruling out H5/H7 LPAI infection on the basis of a thorough
epidemiological investigation, as the factors allowing us to make such
a determination may vary among outbreaks and among States.
Additionally, the OIE guidelines do not specify criteria for making
such a determination.
We do, however, agree with the commenter that the entity
responsible for making this determination should be specified. We have
amended the definitions of H5/H7 LPAI virus infection (infected) in
Sec. Sec. 56.1 and 146.1 in this final rule to indicate that APHIS is
responsible for making this determination. We believe it will be better
to define the criteria for an epidemiological investigation of isolated
serological results through APHIS communication with the Official State
Agencies and Cooperating State Agencies.
We are making one other change to the definition of H5/H7 LPAI
virus infection (infected) in this final rule. We are adding a sentence
indicating that NVSL makes the final determination that H5/H7 LPAI
virus has been isolated and identified, viral antigen or viral RNA
specific to the H5 or H7 subtype of AI virus has been detected, or
antibodies to the H5 or H7 subtype of AI virus have been detected. This
change is intended to clarify for readers who makes an official
diagnosis related to the H5/H7 LPAI virus infection (infected)
definition.
Official State Agency and Cooperating State Agency Roles in Emergency
Response
The regulations in 9 CFR part 56, which were established by the
interim rule, provide for cooperation among APHIS, Official State
Agencies, and Cooperating State Agencies in response to disease
outbreaks.
The term Official State Agency is defined in Sec. Sec. 146.1 and
56.1 (as well as Sec. 145.1) as the State authority recognized by the
Department to cooperate in the administration of the Plan. The term
Cooperating State Agency is defined in Sec. 56.1 as any State
authority recognized by the Department to cooperate in the
administration of the provisions of 9 CFR part 56. Such cooperation
requires the Cooperating State Agency to have the authority to restrict
intrastate movement, conduct cleaning and disinfection, and quarantine
premises, among other things. The Cooperating State Agency is typically
the State animal health authority.
In some States, the Official State Agency is also the State animal
health authority; in some States, the Official State Agency includes
representation from, but is not identical to, the State animal health
authority. For example, the Official State Agency may include
representatives from the poultry industry and from agricultural
extension universities in addition to representatives from the State
animal health authority. While the expertise of the nongovernmental
participants is invaluable in determining how best to respond to an
LPAI outbreak, only the State animal health authority has the authority
to perform the functions described above in response to an outbreak in
accordance with the provisions of part 56. In addition, the regulations
in 9 CFR part 56 contains provisions that apply to all poultry, not
just the breeding and commercial poultry included in the NPIP programs
administered by the Official State Agencies. For poultry not included
in those programs, we cooperate with the State animal health authority
to eradicate an H5/H7 LPAI outbreak and pay indemnity under part 56.
These circumstances necessitated the additional definition of
``Cooperating State Agency.''
One commenter stated that in several sections of the interim rule
relating to activities described in 9 CFR part 56, the regulations
should reflect and clearly recognize that in some jurisdictions the
Official State Agency is not the responder to or manager of disease
events; rather, the Cooperating State Agency is the entity authorized
by State law to manage animal diseases of regulatory significance such
as AI. Therefore, the commenter stated, disease management actions such
as hold orders, quarantined flock management plans, movement
restrictions on animals, equipment or supplies, and cleaning and
disinfection procedures will be under the direction and control of the
Cooperating State Agency.
In the regulations, functions that are analogous to functions
carried out by the Official State Agency under the Plan regulations in
9 CFR part 145 have been assigned to the Official State Agency in parts
56 and 146. However, in States where the Cooperating State Agency is
different from the Official State Agency, the Cooperating State Agency
is the appropriate entity to take on some specific functions for
disease control, as the commenter suggests.
The commenter suggested several specific places in which a
responsibility or function given to the Official State Agency in the
regulations established by the interim rule should be instead assigned
to the Cooperating State Agency.
Paragraphs Sec. Sec. 146.2(f) and 56.2(c) have stated
that States will be responsible for making the determination to request
Federal assistance in the event of an outbreak of H5/H7 LPAI. (The
``Background'' section of the rule erroneously referred to the Official
State Agency, but the rule text refers only to ``States.'') The
commenter stated that we should clarify that the Cooperating State
Agency, rather than Official State Agency, should make this request for
assistance. We agree, and we are making that change to clarify the
regulations in this final rule. (This change necessitates adding the
definition of Cooperating State Agency to Sec. 146.1.)
Section 56.10 describes the initial State response and
containment plans that must be developed for a State and poultry in
that State to be eligible for 100 percent indemnity for costs related
[[Page 10649]]
to an H5/H7 LPAI outbreak. Paragraph (a) of Sec. 56.10 has stated that
the initial State response and containment plan must be developed by
the Official State Agency and administered by the Cooperating State
Agency of the relevant State. The commenter suggested that the
regulations should require that the plan be developed jointly by the
Official State Agency and the Cooperating State Agency and implemented
by the Cooperating State Agency. The commenter stated that giving the
responsibility of developing the plan solely to the Official State
Agency is undesirable and might become the root of significant
difficulty when the Official State Agency is independent from the
Cooperating State Agency, which would create a situation where one
entity creates the plan without the authority, resources, or
responsibility for executing the plan, after which another agency
executes the plan. The commenter stated that involving the responding
agency in the development of the response plan should be expected to
develop a superior plan to one developed without input from the
responders. We agree, and we have amended Sec. 56.10(a) in this final
rule. That paragraph now states that the initial State response and
containment plan must be developed by the Official State Agency and
further provides that, in states where the Official State Agency is
different than the Cooperating State Agency, the Cooperating State
Agency must also participate in the development of the plan. In
addition, we have corrected references to the initial State response
and containment plan in paragraphs (a)(2) and (a)(3) of Sec. 56.2 that
indicated that the Official State Agency was the sole developer of the
initial State response and containment plan.
The definition of commercial meat-type flock in Sec. Sec.
56.1 and 146.1 allows any group of poultry which is segregated from
another group in a manner sufficient to prevent the transmission of H5/
H7 LPAI and has been so segregated for a period of at least 21 days to
be considered as a separate flock, at the discretion of the Official
State Agency. The commenter stated that this discretion should be given
to the Cooperating State Agency, due to the emergency response
responsibilities of the Cooperating State Agency. We assigned this
responsibility to the Official State Agency because it is a type of
task that the Official State Agency has typically been responsible for
in other NPIP activities, and the definition applies to activities
conducted under the NPIP regulations in 9 CFR part 146 as well as in 9
CFR part 56. We are making no changes in response to this comment.
The regulations established by the interim rule in Sec.
56.1 defined flock plan as: ``A written flock management agreement
developed by APHIS and the Official State Agency with input from the
flock owner and other affected parties. A flock plan sets out the steps
to be taken to eradicate H5/H7 LPAI from a positive flock, or to
prevent introduction of H5/H7 LPAI into another flock. A flock plan
shall include, but is not necessarily limited to, poultry and poultry
product movement and geographically appropriate infected and control/
monitoring zones. Control measures in the flock plan should include
detailed plans for safe handling of conveyances, containers, and other
associated materials that could serve as fomites; disposal of flocks;
cleaning and disinfection; downtime; and repopulation.'' The commenter
stated that the responsibilities discussed in this definition are more
properly assigned to the Cooperating State Agency. Again, we assigned
this responsibility to the Official State Agency because it is a task
that the Official State Agency has typically been responsible for in
NPIP activities. We are making no changes in response to this comment.
The ``Background'' section of the interim rule stated
that, while the provisions of 9 CFR part 146 are APHIS requirements for
participation in the Plan, and protocols for sampling, testing, and
other surveillance activities must be approved by APHIS, the active and
diagnostic surveillance undertaken under part 146 is run by the
Official State Agencies in cooperation with poultry producers; the
costs of the surveillance are borne by the Official State Agencies as
well. The commenter stated that the costs of surveillance are borne by
Cooperating State Agencies rather than Official State Agencies.
However, the commenter is incorrect. The cost of the routine, active
surveillance described in 9 CFR part 146 is, in fact, borne by Official
State Agencies and industry when they cooperate to participate in the
Plan.
Vaccination
In the regulations established by the interim rule, paragraphs
(a)(2) and (b)(2) of Sec. 56.2 set out conditions for the transfer of
vaccine for H5/H7 LPAI to Cooperating State Agencies, provided that the
use of vaccine is included in the initial State response and
containment plan, as described in Sec. 56.10(a)(12).
We received one comment that addressed vaccination in general. The
commenter strongly supported the use of vaccination as an emergency
response for table-egg layer flocks. The commenter recommended that
APHIS undertake outreach efforts to remind States that their initial
State response and containment plans should request authority to use
vaccination in advance, rather than waiting for an outbreak. The
commenter also recommended that APHIS notify States that, if they have
already submitted initial State response and containment plans that did
not include provisions for vaccination, they may amend those plans to
include such provisions.
We agree that vaccination has the potential to be a cost-effective
method of eradicating H5/H7 LPAI, especially for table-egg layer
flocks. Under the regulations, the Official State Agency and
Cooperating State Agency for a State will determine whether vaccination
is part of the State's initial response and containment plan. APHIS
will approve the use of vaccination if the initial State response and
containment plan contains appropriate provisions for its use. We
encourage States to include provisions allowing for the use of
vaccination in their initial State response and containment plans,
especially States in which table-egg layer premises are located. We
also encourage States to submit updated initial State response and
containment plans for APHIS approval if they have new ideas about
effective response to and containment of H5/H7 LPAI in their States.
Payment of Indemnity
In the regulations established by the interim rule, Sec. 56.3 sets
out provisions for payment of indemnity.
One commenter asked generally whether indemnity would be provided
if the H5/H7 LPAI virus entered a flock due to illegal activity on the
part of the flock owners or manager.
In Sec. 56.9, ``Claims not allowed,'' paragraph (c) prohibits the
payment of indemnity for any poultry that become or have become
infected with or exposed to H5/H7 LPAI because of a violation of 9 CFR
part 56. This provision addresses the commenter's concern.
Paragraph (a) of Sec. 56.3 describes the activities for which the
Administrator may pay indemnity. These are:
Destruction and disposal of poultry that were infected
with or exposed to H5/H7 LPAI;
Destruction of any eggs destroyed during testing of
poultry for H5/H7
[[Page 10650]]
LPAI during an outbreak of H5/H7 LPAI; and
Cleaning and disinfection of premises, conveyances, and
materials that came into contact with poultry that were infected with
or exposed to H5/H7 LPAI or, in the case of materials, if the cost of
cleaning and disinfection would exceed the value of the materials or
cleaning and disinfection would be impracticable for any reason, the
destruction and disposal of the materials.
One commenter recommended that APHIS consider indemnifying any
vaccination-related costs that are borne by producers in cases in which
vaccination is used as a response to an outbreak of H5/H7 LPAI. The
commenter cited possible costs including, but not limited to, labor
required both for vaccination and for ongoing surveillance, ultimate
disposal costs, and expenses incurred in controlled marketing, such as
the need to purchase more packaging materials than normal.
The regulations as established by the interim rule cover the cost
of disposal of poultry that were infected with or exposed to H5/H7 LPAI
and have been destroyed. The regulations in Sec. 56.2 provide for
APHIS to transfer payment to the Cooperating State Agency for
administering vaccine and conducting surveillance related to an
outbreak of H5/H7 LPAI. APHIS does not believe it is appropriate to
provide indemnity for business costs such as the packaging costs cited
by the commenter. We are making no changes to the regulations in
response to this comment.
One commenter expressed concern that egg producers in the
commenter's State might not be able to fulfill the testing requirements
necessary to be eligible for 100 percent indemnity.
Under Sec. 56.3(b) of the interim rule, if a table-egg layer
premises has 75,000 or more birds, it must participate in the U.S. H5/
H7 Avian Influenza Monitored program in Sec. 146.23(a) in order for
the poultry on that premises to be eligible for 100 percent indemnity.
Table-egg layers on smaller premises are eligible for 100 percent
indemnity if the State in which the table-egg layers are located
participates in the diagnostic surveillance program as described in
Sec. 146.14, and has an initial State response and containment plan
that is approved by APHIS under Sec. 56.10. The commenter stated
elsewhere that the average commercial layer flock in the commenter's
State ranges from 10,000 to 50,000 table-egg layers per farm. Thus, it
appears that most table-egg layer premises in that State would not have
to participate in the U.S. H5/H7 Avian Influenza Monitored program in
Sec. 146.23(a) in order to be eligible for 100 percent indemnity, as
long as the State has in place a diagnostic surveillance program and an
initial State response and containment plan.
Paragraph (b) of Sec. 56.3 generally provides that establishments
above certain size standards must participate in an NPIP AI
surveillance program in order to be eligible to receive 100 percent
indemnity; otherwise, they are only eligible to receive 25 percent
indemnity. However, in the ``Background'' section of the interim rule,
we asked whether it would be appropriate to provide an indemnity
incentive for owners of smaller poultry flocks to participate in a
State program that has testing requirements equivalent to those in part
146, similar to the incentive we provide for larger flocks to
participate in the programs in part 146. Such an incentive, we stated,
could encourage owners of smaller flocks to participate in the State AI
testing programs designed for those flocks. For example, the
regulations could include provisions for APHIS to recognize the testing
requirements of State active surveillance programs as equivalent to the
testing requirements for the H5/H7 LPAI surveillance programs in part
146. We could then provide that if infected or exposed poultry are
eligible to participate in an equivalent active surveillance program,
but do not participate in that program, we would pay indemnity for less
than 100 percent of costs related to an H5/H7 LPAI outbreak in those
poultry
We invited public comment on:
Whether we should recognize State AI surveillance programs
for smaller poultry flocks or other types of poultry as equivalent to
the NPIP surveillance programs in part 146;
If so, which programs we should recognize; and
What changes in the regulations may be appropriate to
provide poultry owners with an incentive to participate in State AI
surveillance programs.
One commenter, from a State department of agriculture, stated that
its surveillance program would likely be considered equivalent to the
requirements in part 146 and that recognizing equivalent programs for
indemnity purposes would encourage many backyard flocks to participate
in such State surveillance programs. The commenter stated that any
program that encourages bird owners to monitor for AI is valuable not
only for the surveillance information it provides, but also as another
opportunity to educate individuals engaged in backyard and other
alternative production methods about biosecurity and good management
practices.
We appreciate the commenter addressing the issues we raised in the
interim rule. After considering the possible implications of
recognizing State surveillance plans as equivalent for the purposes of
establishing an indemnity incentive, however, we have decided not to do
so in this final rule. While the NPIP active surveillance plans are
appropriate for any flock or slaughter plant that is larger than the
size standards promulgated in the interim rule, it is less clear that
it would be possible to design an active surveillance program that was
appropriate for flocks that are smaller than those same size standards.
Indeed, in practice, State programs for flocks and slaughter plants
smaller than the size standards in the interim rule typically focus on
diagnostic surveillance, such as testing birds that have clinical
symptoms consistent with AI, rather than actively testing a certain
number of birds from each participating flock for AI. Diagnostic
surveillance activities in State surveillance programs are typically in
line with the diagnostic surveillance program required for
participating States under Sec. 146.14.
Rather than establish an indemnity incentive for flocks and
slaughter plants that are smaller than the size standards in part 146
to participate in State surveillance programs, we prefer to conduct
outreach to owners of such flocks and slaughter plants to encourage
them to practice appropriate biosecurity and to promptly report
clinical symptoms consistent with AI. We would also encourage owners of
flocks or slaughter plants that are smaller than the size standards to
participate in any State AI surveillance programs that are available to
them. (As noted earlier, commercial table-egg laying premises with
fewer than 75,000 birds, meat-type chicken slaughter plants that
slaughter fewer than 200,000 meat-type chickens in an operating week,
and meat-type turkey slaughter plants that slaughter fewer than 2
million meat-type turkeys in a 12-month period are not required to
participate in the active surveillance programs in subparts B, C, and D
of 9 CFR part 146 in order to receive 100 percent indemnity.)
We are making changes to paragraph (b)(7) in Sec. 56.3 in this
final rule. This paragraph has stated that poultry will be eligible for
25 percent indemnity if they are associated with a flock or slaughter
plant that participates in the Plan, but they are located in a State
that does not participate in the NPIP diagnostic surveillance program
for H5/H7 LPAI, as described in Sec. 146.14 of this chapter,
[[Page 10651]]
or that does not have an initial State response and containment plan
for H5/H7 LPAI that is approved by APHIS. They may be eligible for 100
percent indemnity, however, if they participate in the Plan with
another State that does participate in the NPIP diagnostic surveillance
program for H5/H7 LPAI, as described in Sec. 146.14 of this chapter,
and has an initial State response and containment plan for H5/H7 LPAI
that is approved by APHIS.
It is important to note that, under Sec. 56.3(b)(7), poultry that
do not participate in the Plan and do not meet the size standards in
paragraphs (b)(4) through (b)(6) of Sec. 56.3 have been eligible for
100 percent indemnity even if the State in which they are located does
not have a diagnostic surveillance program or an initial State response
and containment plan. Since the publication of the interim rule, we
have reviewed this provision and found that its inclusion is
inconsistent with the rationale we gave in the interim rule for
providing for the payment of 100 percent indemnity in certain
circumstances.
In the ``Background'' section of the interim rule, we stated that
providing for the payment of 100 percent of eligible costs is
appropriate because participants in the H5/H7 LPAI control program
established by the interim rule assume an economic burden in complying
with the requirements of the control program. The requirements of the
control program make it more likely that an outbreak of H5/H7 LPAI will
be quickly detected and contained; this would tend to lower the amount
of indemnity APHIS may have to pay, but the cost of participating in
the program is mostly borne by producers and Official State Agencies.
However, States that do not have a diagnostic surveillance program
and an initial State response and containment plan have not assumed the
economic burden of participation in the control program. Because they
have not set up an infrastructure by which producers can participate in
the control program, the producers in those States do not assume costs
related to the control program either, unless they participate in the
Plan with another State that has the required diagnostic surveillance
program and initial State response and containment plan. We did not
intend to provide that producers in States without diagnostic
surveillance programs or without initial State response and containment
plans would be eligible for 100 percent indemnity. Accordingly, we are
amending paragraph (b)(7) in Sec. 56.3 to indicate that the
Administrator is authorized to pay indemnity for only 25 percent of the
costs associated with any infected or exposed poultry located in a
State without a diagnostic surveillance program or an initial State
response and containment plan, unless they participate with another
State as described earlier.
We are also amending Sec. 56.3(b)(7) to refer simply to a
diagnostic surveillance program, rather than a ``National Poultry
Improvement Plan diagnostic surveillance program,'' as the regulations
in Sec. 146.14 require that the diagnostic surveillance program
encompass all poultry, not just NPIP flocks.
Paragraph (c) of Sec. 56.3 states that if the recipient of
indemnity for any of the activities listed in paragraphs (a)(1) through
(a)(3) of Sec. 56.3 also receives payment for any of those activities
from a State or from other sources, the indemnity provided under this
part will be reduced by the total amount of payment received from the
State or other sources.
One commenter stated that some States have producer or government-
funded programs that provide funds to be made available in the case of
an AI infection. Most of these types of programs, the commenter stated,
include a provision requiring the local monies to be returned to the
local source if Federal or other funds are later available to indemnify
the affected parties. The purpose of these local funds is to provide a
much quicker response than possible under the Federal program. The
commenter recommended that the Federal program acknowledge that such
funds exist and provide that the recipients of these funds will not
have their Federal indemnity reduced as long as the local indemnity
funds are ultimately returned to the local source.
We may provide the full indemnity for which the poultry are
eligible to poultry owners who have received indemnity from State or
industry sources, as long as the owner provides us with proof that the
indemnity received from those sources has been returned to its source.
A receipt from the payer of the indemnity that was previously received
would be one such proof. It is not necessary to amend the regulations
to accommodate this process, as if the indemnity funds received have
been returned, the provision in Sec. 56.3(c) no longer applies.
Determination of Indemnity Amounts and Appraisals
In the regulations established by the interim rule, Sec. 56.4
described the process by which indemnity amounts would be determined,
including the appraisal process. We received several comments on the
appraisal process.
One commenter stated that a complicated appraisal process should
never be allowed to interfere with the prompt eradication of disease.
As the regulations are written, the commenter stated, no depopulation
could occur until the official appraiser has completed the paperwork
and signed off on the appropriate form with the owners' and mortgagees'
(if necessary) signatures. However, the commenter stated, in reality
there are very few USDA appraisers; if the State's appraisal system is
not permitted to be used, then actions to control the H5/H7 LPAI
outbreak could be delayed. The commenter noted that this could have a
negative effect on poultry production in the entire State in which the
outbreak occurred, as the 90 days that must elapse before U.S. Avian
Influenza Monitored State status can be restored does not begin until
the birds are depopulated and the premises are cleaned and disinfected.
The commenter had two suggestions for how to address the problem.
One was to have pre-approved State and Federal appraisers in every
State. Another suggestion was to have a prescribed list of information
that must be collected concerning each flock prior to depopulation
which the USDA appraiser could use after the fact to calculate an exact
dollar amount.
We appreciate the commenter's concerns and share a desire to ensure
that the appraisal process does not hinder response efforts for a
disease outbreak. The regulations established by the interim rule in
Sec. 56.4(a) and (b) include statements that appraisals of poultry or
eggs must be signed by the owners of the poultry prior to the
destruction of the poultry or eggs, unless the owners, APHIS, and the
Cooperating State Agency agree that the poultry may be destroyed
immediately. (The interim rule neglected to include a similar statement
in Sec. 56.4(c)(2) regarding the appraisal process for materials for
which the cost of cleaning and disinfection would exceed the value of
the materials or cleaning and disinfection would be impracticable for
any reason. We are correcting that omission in this final rule.) We
believe this provision addresses the commenter's concern.
We agree that having a list of pre-approved appraisers would be
useful, and we are working to develop one to improve our response
efforts for all diseases, not just H5/H7 LPAI.
With regard to the commenter's second suggestion, we typically
conduct appraisals for poultry by reviewing
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documentation regarding their production, rather than by visual
inspection. The appraisal estimate is based on the cost of inputs used
during the production process (e.g., feed, shelter, labor) and the
current market price of the relevant poultry or outputs. A more
detailed discussion can be found in the full economic analysis that
accompanied the interim rule, which is available on Regulations.gov
(see footnote 1 in this document for a link to the economic analysis on
Regulations.gov).
One commenter stated that if a flock owner voluntarily destroys a
flock prior to confirmation of infection, there should be a means for a
Cooperating State Agency to verify the number and type of poultry and
eggs destroyed, so that indemnity may be paid after the infection has
been confirmed and an appraisal made.
Only poultry that have been infected with or exposed to H5/H7 LPAI
are eligible for indemnity under 9 CFR part 56. Under the definition of
H5/H7 LPAI exposed, poultry can be determined to be exposed to H5/H7
LPAI if there is a reason to believe that association has occurred with
H5/H7 LPAI or vectors of the virus by the Cooperating State Agency and
confirmed by APHIS. Absent our determination that poultry were infected
with or exposed to H5/H7 LPAI, we will not authorize the payment of
indemnity for the destruction and disposal of that poultry.
As noted earlier, for poultry that are infected with or exposed to
H5/H7 LPAI, we will use records of production to determine how much
indemnity should be paid.
In Sec. 56.4, paragraph (a)(1) states that, for laying hens, the
appraised value should include the hen's projected future egg
production. One commenter agreed with this provision but recommended
that the appraisal should also take into account whether the hen would
have undergone a molt had she not been euthanized. The commenter stated
that not all flocks are molted, but those that are have a longer
productive life -- typically 110-115 weeks rather than approximately 80
weeks.
The commenter is correct that molted hens have a longer productive
life than hens that are not molted. However, there would be
considerable difficulties in determining whether a hen would have been
molted and properly valuing the hen based on that information.
Based on industry figures for hen values, the appraised value of a
hen starts out low for a day-old chick, increases as the bird grows,
and reaches a maximum soon after egg laying begins. As eggs are laid,
the hen's value declines. When molting takes place, the hen's value
increases during the molting phase, followed by a decline in value as
eggs are laid. The process repeats itself for a second molt.
If we were to adopt the commenter's recommendation, our appraisal
model would not increase the value of a hen in its molting phase, but
would have to assign that increase in value to the initial lay. This
would result in no increase in value for hens in the molting phase,
which would mean that our appraisal values of a hen in the molting
phase would not reflect the fair market value of the hen. In addition,
if we made the change suggested by the commenter, we would have to take
the owner's word for whether the hen was to be molted, meaning the
owner would have a strong incentive to state that the hen would be
molted, thus increasing the hen's value, regardless of the actual plans
for molting. We have determined that our present valuation model for
hens more accurately determines their fair market value, as required by
the Animal Health Protection Act. We are making no changes in response
to this comment.
In Sec. 56.4, paragraph (a)(2) sets out the conditions for
determining the amount of indemnity paid for disposal of poultry. The
conditions include a requirement that any disposal of poultry infected
with or exposed to H5/H7 LPAI for which indemnity is requested must be
performed under a compliance agreement between the claimant, the
Cooperating State Agency, and APHIS.\3\ Paragraph (c)(1) sets out the
conditions under which the amount of indemnity paid for cleaning and
disinfection will be determined; similarly, the conditions include a
requirement that any cleaning and disinfection of premises,
conveyances, and materials for which indemnity is requested must be
performed under a compliance agreement between the claimant, the
Cooperating State Agency, and APHIS.
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\3\ Two sentences in Sec. 56.4(a)(2) as it was established by
the interim rule incorrectly referred to ``compensation'' rather
than ``indemnity.'' We are correcting the error in this final rule.
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One commenter stated that requiring that completed, signed
appraisal documents and a written compliance agreement be in place
prior to disposal of infected poultry would severely hamper efforts to
quickly and effectively deal with the infection. The commenter
recommended that we recognize as adequate any disposal activities
undertaken under the approved initial State response and containment
plan. The commenter also stated that cleaning and disinfection should
be allowed to commence without a compliance agreement as long as a
Cooperating State Agency oversees and directs the work and
documentation of expenses is provided. In the event of a disputed
claim, the commenter stated, a process for resolving differences should
be provided.
The regulations require that the destruction and disposal of the
indemnified poultry be conducted in accordance with the initial State
response and containment plan for H5/H7 LPAI. Similarly, the
regulations indicate that APHIS will review claims for indemnity for
cleaning and disinfection to ensure that all expenditures relate
directly to activities described in Sec. 56.5 and in the initial State
response and containment plan described in Sec. 56.10.
Allowing disposal of infected poultry or cleaning and disinfection
to begin without a compliance agreement in place, but promising to pay
indemnity for expenses related to these activities, would amount to
approving expenditures on APHIS' behalf without having a mechanism in
place by which APHIS can provide oversight. This could create disputes
regarding the payment of indemnity. Our oversight of activities for
which we pay indemnity is essential to the responsible use of funds
made available to APHIS for indemnity.
Based on previous disease response efforts, including the effort to
eradicate exotic Newcastle disease outbreaks in 2002-2003, we are
confident that we can conclude compliance agreements with States and
flock owners with sufficient timeliness to ensure an effective disease
response.
One commenter had two comments about how the provisions in Sec.
56.9, ``Claims not allowed,'' relate to the provisions in Sec. 56.4.
Paragraph (a) of Sec. 56.9 states that the USDA will not allow
claims arising out of the destruction of poultry unless the poultry
have been appraised as prescribed in part 56 and the owners have signed
the appraisal form indicating agreement with the appraisal amount as
required by Sec. 56.4(a)(1). The commenter asked whether the poultry
could be appraised after they are destroyed based on the information
collected by the Cooperating State Agency prior to their destruction.
We expect to use a process in which birds are destroyed and
appraisal is performed after destruction in some cases, regardless of
whether the Cooperating State Agency or APHIS collects the necessary
information for the appraisal. This is why the regulations in Sec.
56.4(a)(1) provide that poultry may be destroyed before the owners of
the poultry sign their
[[Page 10653]]
appraisals if the owners, APHIS, and the Cooperating State Agency agree
that the poultry may be destroyed immediately.
Paragraph (b) of Sec. 56.9 states that the USDA will not allow
claims arising out of the destruction of poultry unless the owners have
signed a written agreement with APHIS in which they agree that if they
maintain poultry in the future on the premises used for poultry for
which indemnity is paid, they will maintain the poultry in accordance
with a plan set forth by the Cooperating State Agency and will not
introduce poultry onto the premises until after the date specified by
the Cooperating State Agency.
The commenter stated that this requirement was inconsistent with
the provisions in Sec. 56.4 that require a compliance agreement to be
in place for the disposal of poultry and for cleaning and disinfection,
and that both paragraphs should simply require an agreement rather than
a compliance agreement.
The two requirements refer to two different agreements. The
requirement in Sec. 56.9(b) refers to an agreement for maintenance and
repopulation of the flock, while the requirements in Sec. 56.4 refer
to a compliance agreement under which APHIS will pay for cleaning and
disinfection work that APHIS does not perform. As stated earlier, we
are confident that we can conclude the necessary compliance agreements
promptly under disease emergency conditions, based on past experience.
Destruction and Disposal of Poultry and Cleaning and Disinfection of
Premises, Conveyances, and Materials
In the regulations established by the interim rule, Sec. 56.5 sets
out provisions relating to the destruction and disposal of poultry and
cleaning and disinfection of premises, conveyances, and materials.
Paragraph (a) of Sec. 56.5 sets out the factors on which the
Cooperating State Agency and APHIS will base their selection of a
method of destruction for poultry. These factors include:
The species, size, and number of the poultry to be
destroyed;
The environment in which the poultry are maintained;
The risk to human health or safety of the method used;
Whether the method requires specialized equipment or
training;
The risk that the method poses of spreading the H5/H7 LPAI
virus;
Any hazard the method could pose to the environment;
The degree of bird control and restraint required to
administer the destruction method; and
The speed with which destruction must be conducted.
Three commenters stated that the welfare of the poultry to be
destroyed should be a consideration in our selection of methods for the
destruction of poultry. Two note that the OIE has recently published
animal welfare guidelines that recommend that, when ``animals are
killed for disease control purposes, methods used should result in
immediate death or immediate loss of consciousness lasting until death;
when loss of consciousness is not immediate, induction of
unconsciousness should be non-aversive and should not cause anxiety,
pain, distress or suffering in the animals.'' These commenters
recommended that we adopt the OIE guidelines on this issue in the
regulations.
One of these commenters stated that the USDA has made efforts to
include animal welfare issues in its highly pathogenic avian influenza
(HPAI) response plan, including permitting only methods approved by the
American Veterinary Medical Association and holding discussions with
scientists and animal protect