[Federal Register: September 26, 2006 (Volume 71, Number 186)]
[Rules and Regulations]
[Page 56301-56333]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26se06-12]
[[Page 56301]]
-----------------------------------------------------------------------
Part IV
Department of Agriculture
-----------------------------------------------------------------------
Animal and Plant Health Inspection Service
-----------------------------------------------------------------------
9 CFR Parts 53, 56, 145, 146 and 147
Low Pathogenic Avian Influenza; Voluntary Control Program and Payment
of Indemnity; Final Rule
[[Page 56302]]
-----------------------------------------------------------------------
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: Interim rule and request for comments.
-----------------------------------------------------------------------
SUMMARY: We are amending the regulations to establish a voluntary
program for the control of the H5/H7 subtypes of low pathogenic avian
influenza in commercial poultry under the auspices of the National
Poultry Improvement Plan (the Plan). The control program was voted on
and approved by the voting delegates at the Plan's 2004 National Plan
Conference. We are also providing for the payment of indemnity for
costs associated with eradication of the H5/H7 subtypes of low
pathogenic avian influenza in poultry. The H5/H7 subtypes of low
pathogenic avian influenza can mutate into highly pathogenic avian
influenza, a disease that can have serious economic and public health
consequences. This combination of a control program and indemnity
provisions is 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.
DATES: This interim rule is effective on September 26, 2006. We will
consider all comments that we receive on or before November 27, 2006.
ADDRESSES: You may submit comments by any of the following methods:
Federal eRulemaking Portal: Go to http://www.regulations.gov
and, in the ``Search for Open Regulations'' box,
select ``Animal and Plant Health Inspection Service'' from the agency
drop-down menu, then click on ``Submit.'' In the Docket ID column,
select APHIS-2005-0109 to submit or view public comments and to view
supporting and related materials available electronically. Information
on using Regulations.gov, including instructions for accessing
documents, submitting comments, and viewing the docket after the close
of the comment period, is available through the site's ``User Tips''
link.
Postal Mail/Commercial Delivery: Please send four copies
of your comment (an original and three copies) to Docket No. APHIS-
2005-0109, Regulatory Analysis and Development, PPD, APHIS, Station 3A-
03.8, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please state
that your comment refers to Docket No. APHIS-2005-0109.
Reading Room: You may read any comments that we receive on this
docket in our reading room. The reading room is located in room 1141 of
the USDA South Building, 14th Street and Independence Avenue, SW.,
Washington, DC. Normal reading room hours are 8 a.m. to 4:30 p.m.,
Monday through Friday, except holidays. To be sure someone is there to
help you, please call (202) 690-2817 before coming.
Other Information: Additional information about APHIS and its
programs is available on the Internet at http://www.aphis.usda.gov.
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 that
consists of a variety of programs intended to prevent and control
certain poultry diseases. Participation in all Plan programs is
voluntary, but flocks, hatcheries, and dealers of breeding poultry 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, and dealers that
meet certain disease control standards specified in the Plan's various
programs. As a result, customers can buy poultry that have tested clean
of certain diseases or that have been produced under appropriate
disease-prevention conditions. Prior to the publication of this interim
rule, the regulations in 9 CFR parts 145 and 147 (referred to below as
the regulations) contained the provisions of the Plan.
In this interim rule, we are amending 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. This
program will be administered under the auspices of the NPIP. Until now,
the Plan has only addressed disease issues, including avian influenza
(AI), in flocks of breeding poultry. To accommodate the addition of
commercial poultry to the NPIP, this interim rule establishes a new
part 146, titled ``National Poultry Improvement Plan for Commercial
Poultry,'' in 9 CFR chapter I, subchapter G. This voluntary control
program is intended to complement the voluntary control programs for AI
in breeding poultry--specifically, table-egg layer, meat-type chicken,
meat-type turkey, and waterfowl, exhibition poultry, and game bird
breeding flocks--that are currently contained in part 145 of the Plan's
provisions.
This interim rule also establishes 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. The regulations in part
56 provide the authority to pay indemnity for 100 percent of costs
associated with the eradication of H5/H7 LPAI to most poultry owners.
To provide owners of large commercial poultry flocks and current
participants in the Plan for breeding poultry with an incentive to
participate in the voluntary control programs for AI in parts 145 and
146, this interim rule provides the authority to pay indemnity for only
25 percent of costs associated with eradication of H5/H7 LPAI to those
poultry owners if they do not participate in those voluntary control
programs.
The regulations in part 56 also provide the authority to pay
indemnity to States that participate in the Plan for 100 percent of
certain costs associated with their efforts to eradicate outbreaks of
H5/H7 LPAI. For States that do not participate in the plan, the
regulations authorize the payment of indemnity for 25 percent of those
costs.
The reasons we are establishing the voluntary control program for
commercial poultry and providing for the payment of indemnity in case
of outbreaks of H5/H7 LPAI, and the provisions of the control program
and indemnity regulations, are described below.
Increasing Threat of AI
AI is an infectious disease of birds caused by type A strains of
the influenza virus. The disease, which was first identified in Italy
more than 100 years ago, occurs worldwide. All birds are thought to be
susceptible to infection with AI, though some species are more
resistant to infection than
[[Page 56303]]
others. Wild waterfowl, shorebirds, and gulls serve as a natural host
and reservoir for AI viruses. Fifteen subtypes of influenza virus are
known to infect birds, thus providing an extensive reservoir of
influenza viruses potentially circulating in bird populations. In
addition, the hemagglutinin (H) protein on each subtype of the AI virus
can theoretically be partnered with any one of nine neuraminidase (N)
surface proteins; thus, there are potentially nine different forms of
each subtype. (For example, the nine forms of subtype H5 would be
notated as H5N1, H5N2, H5N3, etc., through H5N9.)
AI viruses can be classified into low pathogenic and highly
pathogenic forms based on the severity of the illness they cause. Most
AI virus strains are low pathogenic and typically cause few or no
clinical signs in infected birds. The World Organization for Animal
Health (also known as the OIE), an international body that, among other
things, classifies animal diseases, considers subtypes of LPAI other
than H5 and H7 to be low-risk diseases and does not require outbreaks
of them to be reported by OIE members, of which the United States is
one. (Diseases whose outbreaks OIE members are required to report to
the OIE are often referred to as notifiable diseases, referring to the
process by which members notify the OIE. The OIE has approved changes
in its classification scheme for LPAI that became effective on January
1, 2006; further discussion of these changes can be found under the
heading ``Trade Restrictions and OIE Guidelines Related to H5/H7 LPAI''
later in this document.) While it can, in rare cases, be transmitted
from birds to humans, the LPAI virus poses no threat to human health.
However, the LPAI virus can mutate into a highly contagious and
rapidly fatal disease, resulting in severe epidemics. The more severe
form of the disease is known as highly pathogenic avian influenza
(HPAI). To date, all outbreaks of the highly pathogenic form have been
caused by influenza A viruses of subtypes H5 and H7.
During the past 20 years, several examples of H5 and H7 LPAI
viruses mutating into HPAI viruses have been documented worldwide
(table 1).
Table 1.--Instances in Which LPAI Viruses of Subtypes H5 and H7 Mutated
Into HPAI Viruses
------------------------------------------------------------------------
Location Year
------------------------------------------------------------------------
Pennsylvania, United States............................. 1983-1984
Mexico.................................................. 1994-1995
Italy................................................... 1999
Chile................................................... 2002
British Columbia, Canada................................ 2004
------------------------------------------------------------------------
Evidence continues to accumulate that LPAI viruses of the H5 and H7
subtypes, if permitted to circulate in poultry populations, can mutate
into HPAI viruses; the larger the number of birds infected with H5/H7
LPAI, the more likely it is that the virus will mutate into HPAI in one
of them.
HPAI is characterized by sudden onset, severe illness, and rapid
death, with a mortality rate that can approach 100 percent. HPAI is
listed by the OIE as a notifiable disease, meaning that outbreaks of
HPAI must be reported by OIE members. Diseases listed as notifiable are
those that exhibit some combination of potential for international
spread, potential for significant morbidity or mortality among
populations not exposed to the disease, and potential for transmission
to humans (and, if that potential is present, potential for severe
consequences of infection in humans). The OIE also takes into account
whether the disease is an emerging disease when determining whether to
list it. Although it is not an emerging disease, HPAI fulfills all the
other conditions for being listed as a notifiable disease, including
having the potential for severe consequences of infection in humans.\1\
---------------------------------------------------------------------------
\1\ The OIE's criteria for listing a disease as one that must be
reported by OIE members may be viewed on the Internet at http://www.oie.int/eng/normes/mcode/en_
chapitre--2.1.1.htm#chapitre--
2.1.1.
---------------------------------------------------------------------------
The number of outbreaks of HPAI in the world's commercial poultry
has grown in the years since 1955 (table 2), with particularly dramatic
growth in the last 10 years. There is also evidence that AI virus has
been directly transmitted from birds to humans several times in recent
years (table 3). Incidents of human infection with HPAI are
specifically noted in the table.
Table 2.--Outbreaks of HPAI by Decade Since 1955
------------------------------------------------------------------------
Number of
Years outbreaks
------------------------------------------------------------------------
1955-1964............................................... 3
1965-1974............................................... 1
1975-1984............................................... 4
1985-1994............................................... 5
1995-2004............................................... 10
------------------------------------------------------------------------
Table 3.--Transmission of AI Virus From Birds to Humans
----------------------------------------------------------------------------------------------------------------
Location Year Virus subtype
----------------------------------------------------------------------------------------------------------------
Hong Kong................................ 1997 H5N1 (HPAI).
Hong Kong................................ 1999 H9N2.
Virginia, United States.................. 2002 H7N2 (mild upper respiratory infection and
conjunctivitis).
The Netherlands.......................... 2003 H7N7 (HPAI).
New York, United States.................. 2003 H7N2 (immunosuppressed individual).
Southeast Asia, Iraq, Turkey............. 2003-2006 H5N1 (HPAI).
British Columbia, Canada................. 2004 H7N3 (HPAI).
----------------------------------------------------------------------------------------------------------------
As mentioned previously, the transmission of HPAI from birds to
humans poses serious risks for public health. The first documented
infection of humans with an avian influenza virus occurred in Hong Kong
in 1997, when the H5N1 strain caused severe respiratory disease in 18
humans, of whom 6 died. The infection of humans coincided with an
epidemic of HPAI, caused by the same strain, in Hong Kong's poultry
population.
Since December 2003, a growing number of Southeast Asian countries
have reported outbreaks of HPAI responsible for the deaths of millions
of birds and at least 105 humans. The World Health Organization (WHO)
reports that these outbreaks of H5N1 HPAI among poultry are the largest
and most severe on record, and that all the conditions for a human
pandemic of H5N1 influenza have been met save the establishment of
efficient and sustained
[[Page 56304]]
human-to-human transmission of the virus. The WHO further warns that
``the risk that the H5N1 virus will acquire this ability will persist
as long as opportunities for human infections occur. These
opportunities, in turn, will persist as long as the virus continues to
circulate in birds, and this situation could endure for some years to
come.'' \2\
---------------------------------------------------------------------------
\2\ See ``WHO Avian influenza frequently asked questions'' at
http://www.who.int/csr/disease/avian_influenza/avian_faqs/en/index.html
(as of August 11, 2006).
---------------------------------------------------------------------------
Trade Restrictions and OIE Guidelines Related to H5/H7 LPAI
Given the information discussed above about the ability of H5/H7
LPAI to mutate into HPAI, several U.S. trading partners have put in
place restrictions on the importation of poultry and poultry products
in an effort to prevent the introduction of H5/H7 LPAI. Additionally,
the U.S. Department of Agriculture has observed that some trading
partners now require a greater level of assurance that neither HPAI nor
LPAI exist in source flocks for poultry exported from the United
States.
The European Union (EU) has reported that it is currently
considering the option of including H5/H7 LPAI in its statutory
definition of AI. This would mean that poultry or poultry products
exported to the EU from countries where H5/H7 LPAI is present would be
subject to the same stringent requirements that apply to poultry or
poultry products exported to the EU from countries where HPAI is
present. The EU is also considering what regulatory responses, possibly
including the use of vaccines, may be appropriate for outbreaks of H5/
H7 LPAI in the EU.
In addition, spurred by the increasing importance of controlling
H5/H7 LPAI, the OIE adopted new guidelines for AI in its Terrestrial
Animal Health Code chapter on AI in May 2005. These guidelines became
effective on January 1, 2006.\3\ The OIE guidelines in the Terrestrial
Animal Health Code are recognized by the World Trade Organization as
international recommendations for animal disease control.
---------------------------------------------------------------------------
\3\ The recommendations may be viewed on the Internet at http://www.oie.int/eng/normes/mcode/en_chapitre_2.7.12.htm
.
---------------------------------------------------------------------------
The new OIE guidelines define notifiable avian influenza (NAI) as
an infection of poultry caused by any influenza A virus of the H5 or H7
subtypes or by any AI virus with an intravenous pathogenicity index
greater than 1.2, or, as an alternative, an AI virus with at least 75
percent mortality. NAI viruses are divided into highly pathogenic
notifiable avian influenza and low pathogenicity notifiable avian
influenza. However, with regard to such issues as restrictions on
importation, eradication of outbreaks, and determination of whether a
country or a region within a country is free of AI, the guidelines
treat HPAI and H5/H7 LPAI as posing similar risks.
Under the new guidelines, therefore, OIE members are obligated to
report outbreaks of H5/H7 LPAI in addition to outbreaks of HPAI. In
addition, in order to export poultry and poultry products to countries
whose regulations are modeled on the OIE guidelines, countries or
regions within countries may conceivably be required to have in place
surveillance mechanisms sufficient to demonstrate freedom from both H5/
H7 LPAI and HPAI and disease response measures sufficient to eradicate
H5/H7 LPAI and HPAI. Establishing such surveillance mechanisms and
disease response measures is one of the purposes of this interim rule.
Current AI Control and Surveillance Within the United States
HPAI does not currently exist in the United States. However, H7N2
LPAI viruses have been present in the poultry markets of New York and
New Jersey since 1994. The amino acid sequences of the hemagglutinin
proteins from some of these viruses have been found to carry more than
two basic amino acids adjacent to the hemagglutinin cleavage site,
raising concern that additional mutations could result in a highly
pathogenic virus.
In addition, occasional LPAI outbreaks in commercial poultry in the
United States, such as the LPAI outbreaks in Virginia, Delaware,
Connecticut, Maryland, and Texas, have led some countries to place
restrictions on the importation of poultry and poultry products from
the United States.
In the United States, a combination of active and diagnostic
surveillance for AI is used. Diagnostic surveillance 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.
Active surveillance for AI in U.S. poultry has been conducted in
three settings. The first involves the National Poultry Improvement
Plan disease control provisions for breeding poultry in 9 CFR part 145.
The Plan provides for a ``U.S. Avian Influenza Clean'' classification
for table-egg layer breeding flocks in Sec. 145.23(h); for meat-type
chicken breeding flocks in Sec. 145.33(l); and for waterfowl,
exhibition poultry, and game bird breeding flocks in Sec. 145.53(e).
The Plan also provides for a ``U.S. H5/H7 Avian Influenza Clean''
classification for turkey breeding flocks in Sec. 145.43(g). These
active surveillance programs are used to certify baby chicks, poults,
and hatching eggs for interstate commerce or export from the United
States. All flocks tested since these programs began in 2000 have
returned negative results for AI.
Second, in recent years a number of broiler and turkey meat
producers have begun conducting AI serology tests on samples collected
from their flocks just prior to slaughter to meet the requirements
Mexico has established for exporting poultry meat to that country.
Since Mexico established this requirement, all flocks tested in order
to fulfill it have returned negative results for AI.
Third, several States have established AI surveillance programs
based on the risk of AI exposure unique to their States or regions. For
example, Minnesota has a long-standing AI surveillance program for
turkeys; Texas established a surveillance program for commercial
poultry flocks near the Mexican border following the Mexican HPAI
outbreak in 1994-95; and Pennsylvania, New York, and New Jersey have
ongoing surveillance programs in live bird markets and their supply
flocks as a result of the LPAI infections that persist in that
marketing system.
However, given the risk that a persistent H5/H7 LPAI infection
could mutate into HPAI, the possible trade disruptions that may be
associated with H5/H7 LPAI now and in the future, and the OIE's
adoption of guidelines designating H5/H7 LPAI as a notifiable disease,
we believe that it is necessary to establish a national control program
that provides for active and diagnostic surveillance for H5/H7 LPAI in
both commercial and breeding poultry flocks. In case H5/H7 LPAI is
discovered, we believe it is also necessary to establish a plan for
controlling and eradicating H5/H7 LPAI outbreaks and to provide the
authority to pay indemnity for costs associated with control and
eradication of the disease.
Overall Approach of the Voluntary Control and Indemnity Program
Accordingly, the Animal and Plant Health Inspection Service
(APHIS), the U.S. Animal Health Association's Transmissible Diseases of
Poultry Committee, and the National Poultry Improvement Plan have
worked to develop regulatory options for H5 and
[[Page 56305]]
H7 LPAI for commercial poultry--specifically, table-egg layers, meat-
type chickens, and meat-type turkeys. These options were intended to
augment the current active surveillance programs for breeding flocks of
table-egg layers, meat-type chickens, meat-type turkeys, and waterfowl,
exhibition poultry, and game birds that have been included in the NPIP.
(We may develop programs for surveillance and control of H5/H7 LPAI in
other types of commercial or breeding poultry in the future.)
During a meeting APHIS organized with State and industry
representatives that took place in May 2002 in San Antonio, TX,
participants identified three key components that the H5/H7 LPAI
program should contain. In cooperation with States and industry, APHIS
developed provisions describing such a program; these provisions were
approved at the July 2004 NPIP meeting in San Francisco, CA, and they
form the basis of this interim rule. In each of these components,
Federal, State, and industry stakeholders all have an important part to
play, and efforts to detect and eradicate outbreaks of H5/H7 LPAI will
rely on cooperation among all three groups. Each component of the
program is discussed in detail below.
The first component discussed here is a diagnostic surveillance
program for all poultry, undertaken by the Official State Agencies
according to plans approved by APHIS. In the new part 146 establishing
the voluntary control program, Sec. 146.14 sets out criteria for a
diagnostic surveillance program. Each State that wishes to participate
in the Plan for commercial poultry must implement a diagnostic
surveillance program that is approved by APHIS. However, the diagnostic
surveillance programs that States are required to implement apply to
all poultry in the State, not just those included in the NPIP.
Diagnostic surveillance programs developed under this interim rule
will designate H5/H7 LPAI as a disease reportable to the State
veterinarian and require that 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. This is
consistent with the recommendation in paragraph 2a of Article 3.8.9.2
of the OIE Guidelines for Surveillance of Avian Influenza.\4\
---------------------------------------------------------------------------
\4\ These guidelines may be viewed on the Internet at http://www.oie.int/eng/normes/mcode/en_chapitre_3.8.9.htm#chapitre_3.8.9
.
---------------------------------------------------------------------------
The second component discussed here is the initial State response
and containment plans for each participating State that are required by
the new part 56 established by this interim rule. These plans detail
what actions will be taken in response to an outbreak of H5/H7 LPAI;
they will also be developed by the States, and they must be approved by
APHIS before a State can begin participation in the voluntary control
and indemnity program. Where the regulations in part 56 set out uniform
requirements for emergency response, they are consistent with the OIE
guidelines.
The requirements for both the diagnostic surveillance plan and the
initial State response and containment plan provide for some level of
variation on the State level, as long as the plans meet certain
performance standards. As noted previously, several States already have
diagnostic surveillance and emergency response measures of some kind in
place for H5/H7 LPAI. (We are aware of State LPAI surveillance programs
in Arkansas, California, Delaware, Georgia, Iowa, Maryland, Minnesota,
North Carolina, Pennsylvania, Texas, and Virginia. However, it is
difficult to estimate the proportion of U.S. poultry that are covered
by State programs, as other States may also have such initiatives in
place.) We believe it is better to build a Federal program that
recognizes State activities than to replace them with a strictly
Federal program. In our judgment, the States that already have control
measures in place to address H5/H7 LPAI may be able to adapt those
measure to meet the performance standards that this interim rule sets
out for surveillance and emergency response measures with few or no
changes. For States that do not have control measures in place to
address H5/H7 LPAI, the combination of State autonomy with Federal
review will give States flexibility to develop plans based on local
conditions, including industry organization, marketing patterns, and
anticipated disease risks, while ensuring that the State-developed
control measures meet minimum standards for surveillance and emergency
response.
The third component in the voluntary control program is active
surveillance, based on testing of birds or eggs for breeding poultry
and commercial table-egg layers and testing at the flock level or at
slaughter for commercial meat-type chickens and meat-type turkeys, and
conducted according to plans detailed in the regulations. The active
surveillance program focuses on establishing that individual
compartments are free of H5/H7 LPAI. The OIE defines a compartment as
``one or more establishments under a common biosecurity management
system containing an animal subpopulation with a distinct health status
with respect to a specific disease or specific diseases for which
required surveillance, control and biosecurity measures have been
applied for the purpose of international trade.'' \5\ For poultry types
grown to produce eggs (breeding poultry and table-egg layers), the
compartment level of organization is the flock. For poultry types grown
to produce meat (meat-type chickens and meat-type turkeys), the
compartment level of organization is the slaughter plant and all the
flocks under the same ownership as or otherwise affiliated with the
slaughter plant. (For information on affiliation with a slaughter
plant, see the section headed ``Administration'' later in this
document.)
---------------------------------------------------------------------------
\5\ See the Terrestrial Animal Health Code General Definitions
at http://www.oie.int/eng/normes/mcode/en_chapitre_1.1.1.htm#terme_compartiment
.
---------------------------------------------------------------------------
In 9 CFR part 145, the Plan provides for a ``U.S. Avian Influenza
Clean'' classification for table-egg layer breeding flocks, for meat-
type chicken breeding flocks, and for waterfowl, exhibition poultry,
and game bird breeding flocks. The Plan also provides for a ``U.S. H5/
H7 Avian Influenza Clean'' classification for turkey breeding flocks.
The ``Clean'' designation is used because these programs require
testing of 30 birds per flock; these requirements are sufficient to
establish the flocks as free of AI (or, in the case of turkeys, H5/H7
AI) at a 95 percent confidence interval for a 10 percent infection
rate.
Table-egg layer flocks, meat-type chicken and meat-type turkey
slaughter plants, and States participating in the voluntary control
program in 9 CFR part 146 may earn the ``U.S. H5/H7 Avian Influenza
Monitored'' classification. In the case of table-egg layer and meat-
type chicken flocks, the programs require testing of 11 birds per flock
or per shift, which is sufficient to establish the flocks and slaughter
plants as free of H5/H7 LPAI at a 95 percent confidence interval for a
25 percent infection rate, for any size group of birds. In the case of
meat-type turkeys, fewer birds are tested, but the testing is
concentrated on birds showing clinical symptoms consistent with H5/H7
LPAI. The higher infection rate targeted in the testing for commercial
poultry is appropriate because, in practice, an H5/H7 LPAI infection in
one bird in a commercial poultry flock would quickly spread to almost
all the other birds in the flock.
[[Page 56306]]
The active surveillance programs for the NPIP apply only to the
types of poultry cited above and only to flocks or slaughter plants
that participate in the NPIP. In addition, for commercial poultry, a
participating flock or slaughter plant is required to participate in
the active surveillance program only if it is larger than a certain
size standard. For table-egg layer flocks, the standard is 75,000
birds, which is consistent with the American Egg Board's definition of
commercial egg producers. For meat-type chicken slaughter plants, the
standard is slaughtering 200,000 meat-type chickens in an operating
week, while for meat-type turkey slaughter plants, the standard is
slaughtering 2 million meat-type turkeys in a 12-months period; both of
these standards are consistent with Watt Publishing Companies' listing
of commercial meat-type chicken and turkey slaughter operations,
respectively.
Although we chose these size standards based on standard industry
references, the purpose behind having size standards is to concentrate
resources on testing flocks and slaughter plants that are associated
with a relatively high percentage of the total U.S. population of
commercial poultry of these types. Estimates indicate that the poultry
associated with flocks and slaughter plants above these size standards
comprise a very high percentage of the total number of commercial
poultry:
According to the American Egg Board, the top 260 table-egg
layer producers own over 3,000 flocks with 75,000 hens or more.
Together, these flocks comprise approximately 95 percent of all table-
egg layers in the United States.
According to Watt Publishing Companies, the top 20 U.S.
meat-type chicken producers produce 91 percent of the entire U.S.
production of chicken meat; these companies slaughter approximately
152.71 million birds a week. The next 20 companies slaughter
approximately 17.5 million birds a week. Meat-type chicken slaughter
plants owned by these companies slaughter well over 200,000 birds a
week. The top 40 chicken companies in the United States produce close
to 100 percent of the annual U.S. broiler meat production.
According to Watt Publishing Companies, the top 27 meat-
type turkey companies produce over 6992.9 million pounds of live weight
turkey meat annually, approximately 97 percent of U.S. annual
production of turkey meat. The slaughter plants owned by all of these
27 companies slaughter more than 2 million birds in a 12-month period.
By concentrating the active surveillance on such flocks and
slaughter plants, we believe we will be employing the Federal, State,
and industry resources that will be used to conduct this surveillance
as effectively as possible. We invite comment from the public on
whether these size standards and our use of them are appropriate.
Flocks and slaughter plants that participate in these programs thus
can make statements about their freedom from H5/H7 LPAI. In addition,
for table-egg layers and meat-type turkeys, a State can be declared a
H5/H7 LPAI Monitored State with respect to those types of poultry if
all large flocks or slaughter plants are participating in the relevant
program in part 146 and certain other conditions are fulfilled. (No
State-level program exists for meat-type chickens; we do not believe
such a program is necessary.) Records of testing under the active
surveillance programs will be made available for inspection by State
and APHIS personnel.
The OIE guidelines also recommend that surveillance mechanisms be
established for high-risk populations of poultry such as places where
birds and poultry of different origins are mixed, such as live bird
markets, and poultry in close proximity to waterfowl. These
surveillance mechanisms are not part of this interim rule. However, it
is important to note that these issues are addressed in other APHIS
programs and activities. For example, in the live bird marketing
system, 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. In addition, in spring 2006, under the interagency HPAI plan,
the USDA and its cooperators planned to collect between 75,000 and
100,000 samples from live and dead wild birds in all States and 50,000
samples of water or feces from high-risk waterfowl habitats across the
United States for the purposes of AI surveillance. These programs are
consistent with the OIE recommendation.
The program we are establishing is voluntary because some producers
and some States may not wish to participate. Fulfilling the
requirements of the program will entail some additional costs for
producers and States. However, the incentives to participate are also
considerable. Under this interim rule, APHIS is authorized to pay 100
percent indemnity for the destruction and disposal of poultry infected
with or exposed to H5/H7 LPAI; 100 percent indemnity for the
destruction of any eggs destroyed during testing of poultry for H5/H7
LPAI during an outbreak of H5/H7 LPAI; and 100 percent indemnity for
cleaning and disinfecting premises, conveyances, and materials (or, in
certain cases, for the destruction and disposal of materials) to most
producers, including all participants in the voluntary control
programs, provided that the State in which the outbreak occurs is a
participant in the control program and has developed an initial State
response and containment plan that has been approved by APHIS. For
commercial poultry producers who do not choose to participate in the
voluntary H5/H7 LPAI control programs in part 146, and for breeding
poultry producers who participate in the Plan but do not participate in
the AI control programs in part 145, this interim rule authorizes APHIS
to pay indemnity for only 25 percent of the costs of those activities.
(A detailed description of the conditions that would cause a producer
to be eligible for 25 percent indemnity can be found later in this
document under the heading ``Payment of Indemnity.'')
In addition, under this interim rule, APHIS is authorized to
establish cooperative agreements with Cooperating State Agencies to pay
for costs associated with the eradication of H5/H7 LPAI outbreaks and
to transfer vaccine for H5/H7 LPAI for use by Cooperating State
Agencies in accordance with the initial State response and containment
plan, as approved by APHIS. Costs that may be paid under a cooperative
agreement include the cost of surveillance and monitoring associated
with poultry that have been infected with or exposed to H5/H7 LPAI and
the cost of vaccine administration by Cooperating State Agencies. APHIS
is authorized to pay 100 percent of these costs to participating States
and 25 percent of these costs to nonparticipating States.
All States with commercial poultry operations that meet the size
standards of the control program we have developed currently
participate in the NPIP for breeding poultry, and they are expected to
participate in the program established by this interim rule. In
addition, the State Poultry Executive Association has indicated that
all State poultry associations strongly support the control program;
the National Chicken Council, National Turkey Federation, United Egg
Producers, and U.S. Poultry and Egg Association have indicated their
strong support as well.
On the producer level, 100 percent of commercial table-egg layer
chickens,
[[Page 56307]]
meat-type chickens, and meat-type turkeys that meet the size standards
of the control program we have developed are currently produced from
breeding flocks that participate in the NPIP. Besides this natural link
to the NPIP, and the indemnity incentives described earlier, another
incentive for participation is the fact that participation in the H5/H7
LPAI control program has the potential to serve as a seal of approval
for producers who wish to export their products to foreign markets; as
discussed earlier in this document, countries modeling their
regulations on the OIE guidelines may in the future establish
requirements that poultry and poultry products originate from flocks in
H5/H7 LPAI control programs. It is believed that the possible loss of
export markets for nonparticipants in the event of an outbreak of H5/H7
LPAI, combined with the indemnity incentives, will bring a very high
percentage of the commercial poultry industry into the new voluntary
program. We expect that at least 90 percent of commercial poultry
operations that meet the size standards will participate. This is
similar to the participation level in the current Plan programs for
breeding flocks, in which we have a nearly 100 percent participation
level from chicken and turkey companies. With the proposed surveillance
levels, a 90 percent participation rate would accomplish the goals of
the program. Outreach and education from NPIP office through the
Official State Agencies will be necessary to maintain participation
levels.
For these reasons, we do not believe that making the program
voluntary will have an adverse effect on its ability to prevent
outbreaks of H5/H7 LPAI within the United States; rather, we believe
most commercial poultry producers and States with substantial
commercial poultry industries will participate in the voluntary
program, particularly given that on the State level the program allows
for some flexibility. In addition, the diagnostic surveillance portion
will allow for the detection of H5/H7 LPAI in any non-participating
establishments.
As described, the voluntary control program established by this
interim rule is consistent with the three key characteristics that a
control program for H5/H7 LPAI in the commercial poultry industry
should have, as identified at the May 2002 meeting:
1. Autonomy for the Official State Agency (the animal health
authority in a particular State recognized by APHIS to cooperate in the
administration of the Plan) wherever possible;
2. Federal review of surveillance and response measures at the
State level; and
3. Voluntary participation for producers on a cooperative basis
with State and Federal authorities.
Differences Between This Approach and the Approach Used To Control LPAI
Outbreaks in Virginia and Texas in 2002
In 2002, nearly 4 million birds were depopulated under State and
Federal authority in Virginia and Texas due to outbreaks of H7 LPAI (in
Virginia) and H5 LPAI (in Texas). In order to provide an incentive for
poultry owners and contract growers to participate in the depopulation
effort, APHIS provided compensation to poultry owners and contract
growers in Virginia in an interim rule published in the Federal
Register on November 4, 2002, and made effective December 9, 2002 (67
FR 67089-67096, Docket No. 02-048-1). A subsequent final rule effective
and published in the Federal Register on July 18, 2003 (68 FR 42565-
42570, Docket No. 02-048-2) provided compensation to poultry owners and
contract growers in Texas for the same costs for which Virginia poultry
owners and contract growers were compensated in the November 2002
interim rule and adjusted the percentage of costs for which indemnity
was provided to poultry owners in both States.
The specific provisions relating to these outbreaks established by
the November 2002 interim rule and the July 2003 final rule in the
general indemnity regulations in 9 CFR part 53 have been the only
regulations in 9 CFR chapter I dealing specifically with compensation
for outbreaks of H5 or H7 LPAI. Since the approach of the regulations
we are establishing in 9 CFR part 56 differs in some respects from the
approach of the regulations established by the November 2002 interim
rule and the July 2003 final rule, we will discuss here how and why the
approaches differ.
The November 2002 interim rule allowed for poultry owners to
receive compensation for 50 percent of the costs they incurred related
to destruction and disposal of birds affected by H5 or H7 LPAI, minus
the amount paid in compensation to contract growers; the July 2003
final rule increased that amount to 75 percent. Under both rules,
contract growers were eligible to receive indemnity for 100 percent of
the costs they incurred; this compensation was subtracted from the
compensation paid to the poultry owners. Costs eligible for indemnity
under 9 CFR part 53 included the market value of the birds destroyed
and the costs of destruction and disposal of animals and materials
required to be destroyed to eradicate a disease and the cost of
cleaning and disinfection of premises, conveyances, and materials.
(While the regulations did not state this explicitly, compensation was
paid for eggs destroyed during the Virginia and Texas LPAI outbreaks
for testing for H5/H7 LPAI.)
Prior to the publication of this interim rule, any Federal
indemnification relating to H5/H7 LPAI would have been paid under the
authority of the general indemnity regulations in 9 CFR part 53;
indemnity would have been provided in the context of a cooperative
program with a State, and APHIS was authorized to provide indemnity for
50 percent of the above costs in accordance with Sec. 53.2(b).
The new part 56 we are establishing will provide indemnity for the
market value, destruction, and disposal of poultry that have been
infected with or exposed to H5/H7 LPAI; the destruction of any eggs
destroyed during an outbreak for testing for H5/H7 LPAI; and cleaning
and disinfection of premises, conveyances, and materials that were
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,
indemnity for the destruction and disposal of the materials. These
costs are identical to the costs for which indemnity was provided for
the LPAI outbreaks in Virginia and Texas.
However, the new part 56 also establishes mechanisms to address
some additional costs not explicitly included in the indemnity provided
for the outbreaks in Virginia and Texas. This interim rule also
provides for the establishment of cooperative agreements with
Cooperating State Agencies to pay for the costs of surveillance and
monitoring, to transfer vaccine from APHIS to a State under certain
controls, and to pay for vaccine administration associated with an
outbreak. Although the November 2002 and July 2003 rules did not
discuss the issue, the costs of surveillance and monitoring were also
assumed by APHIS in the Virginia and Texas outbreaks; vaccination was
not used in those control and eradication efforts.
Cooperative agreements established under this interim rule will
provide for payment of the costs of surveillance and monitoring only as
they relate to a specific disease outbreak. We are providing for the
authority to pay the cost of surveillance and monitoring as they relate
to a disease outbreak because
[[Page 56308]]
we believe it is appropriate for APHIS to pay for actions undertaken at
APHIS' direction to confirm successful eradication of an outbreak of
H5/H7 LPAI.
Cooperative agreements established under this interim rule may also
provide for the transfer of vaccine from APHIS to a State for disease
control purposes, provided that the vaccine is transferred and used in
accordance with a previously approved initial State response and
containment plan, and provide for the payment to the States of the cost
of administering the vaccine. Compared to the cost of depopulation of
poultry, vaccination of poultry can be a more cost-effective method of
controlling the spread of LPAI. (It should be noted that, under this
interim rule, vaccination for H5/H7 LPAI may not be performed except as
a disease control method after an outbreak has occurred.) For example,
a table-egg layer can be vaccinated for AI with two inoculations at a
total cost of 25 cents per bird. By comparison, the total cost to
APHIS, the Cooperating State Agency, and the poultry owner of
depopulating and replacing a table-egg layer can reach $10 per bird.
Thus, for a typical 2-million-bird table-egg layer complex, the
difference in cost between vaccination and depopulation could reach
$19.5 million. Therefore, we believe it is important to explicitly
provide for both the transfer of vaccine and its administration,
subject to appropriate controls, to ensure that this means of
controlling the spread of LPAI is available to APHIS and to Cooperating
State Agencies.
As noted previously, the new regulations in part 56 will provide
for the authority to pay indemnity of 100 percent of eligible costs for
most producers and will provide for the establishment of cooperative
agreements with participating States through which States will be
eligible to receive 100 percent of the costs covered under the
cooperative agreements. We believe that providing for the payment of
100 percent of eligible costs, rather than 75 percent as in the July
2003 final rule, is appropriate because participants in the H5/H7 LPAI
control program that this interim rule establishes 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.
While APHIS has recently provided funding to States for ongoing
LPAI surveillance under cooperative agreements, these do not come close
to covering the total State and industry cost of participation in the
program; for example, the NPIP budgeted $2 million in fiscal year 2006
for cooperative agreements with 24 States for LPAI surveillance in
commercial poultry, but the State costs for surveillance for LPAI were
reported to be $15 million, while the industry costs were reported to
be $25 million, based on the costs of the testing conducted in the
NPIP. We expect that the States and industry would continue to bear
most of the cost burden after the publication of this interim rule, as
they have for the provisions of the NPIP relating to breeding poultry.
Therefore, in the event of an outbreak, it is appropriate to indemnify
participating owners of commercial poultry flocks that meet certain
size standards for the full amount of the costs that are eligible for
indemnity and that are associated with the outbreak and to pay for the
full amount of costs that Cooperating State Agencies incur in
eradicating the outbreak.
The interim rule also provides for the authority to pay 100 percent
indemnity to owners of flocks that do not meet these size standards,
regardless of whether these smaller flocks are participating in the
NPIP. We believe that providing for the payment of 100 percent of
eligible costs to all flock owners is appropriate because the OIE now
lists all H5 and H7 AI viruses, both LPAI and HPAI, as serious diseases
that are required to be reported by member countries. In essence, the
premise of the OIE guidelines is that, because H5/H7 LPAI has the
potential to mutate into HPAI, it should be treated very similarly to
HPAI by member countries. Therefore, we believe that it is consistent
to provide for payment of 100 percent indemnity for costs associated
with H5/H7 LPAI to large commercial poultry producers and breeding
poultry producers who participate in the voluntary control program, all
small poultry producers, and participating States, as we do for costs
associated with HPAI under the general indemnity regulations in Sec.
53.2(b). Given expected participation rates, this will mean that 100
percent indemnity will be available for almost all producers and
States. Providing indemnity for 25 percent of associated costs for the
small number of commercial poultry producers and States who do not
participate in the Plan and breeding poultry producers who participate
in the Plan but not in its AI programs serves to encourage
participation in the voluntary control program, whose surveillance
requirements are consistent with the OIE guidelines.
Finally, the indemnity regulations established in this interim rule
also provide for the distribution of payments between producers and
contract growers. The distribution of payments provided for in this
interim rule is similar to the one APHIS used to distribute indemnity
that was paid to producers and contract growers due to LPAI outbreaks
in Virginia and Texas in 2002. This will help ensure full participation
by contract growers in the diagnostic surveillance program described
later in this document. This formula is described in detail under the
heading ``Conditions For Payment'' later in this document.
Prior to the publication of this interim rule, 9 CFR part 53 still
contained indemnity provisions relating to the LPAI outbreaks in
Virginia and Texas in 2002. We have paid all the indemnity claims
related to these incidents that we anticipate paying. To update the
regulations, this interim rule removes the indemnity provisions
relating to the LPAI outbreaks in Virginia and Texas in 2002 from 9 CFR
part 53.
Section-by-Section Explanation of New Parts 146 and 56
In this interim rule, in a new part 146, we are providing for the
establishment of active and diagnostic surveillance programs for
commercial table-egg layers, meat-type chickens, and meat-type turkeys;
these programs will be developed by each participating State and
approved by APHIS. Participating commercial table egg-layer, meat-type
chicken, and meat-type turkey flocks may earn the classification ``U.S.
H5/H7 Avian Influenza Monitored.'' States participating in the active
surveillance programs may also earn the classification ``U.S. H5/H7
Avian Influenza Monitored State'' with respect to commercial table-egg
layers and meat-type turkeys. (As discussed earlier in this document,
the AI programs in 9 CFR part 145 for table-egg layer, meat-type
chicken, and waterfowl, exhibition poultry, and game bird breeding
flocks provide the classification ``U.S. Avian Influenza Clean,'' and
the AI program for turkey breeding flocks provides the classification
``U.S. H5/H7 Avian Influenza Clean.'' Currently, the NPIP contains no
State classifications relating to AI for breeding poultry.) The new
part 146 also contains specific requirements for collecting samples to
test for AI and guidelines for States to
[[Page 56309]]
use in establishing a diagnostic surveillance program.
Where possible, the language and structure of new 9 CFR part 146 is
modeled on that of 9 CFR part 145, which, as noted above, contains the
provisions of the NPIP that apply to breeding poultry. The NPIP
provisions in part 145 are well established and familiar to many
poultry producers, and we believe that modeling the new part 146 on
part 145 will enhance the effectiveness of the new Plan provisions for
commercial poultry. We have not included provisions from part 145 that
are not relevant to commercial poultry in the new part 146.
The new part 56 provides for the payment of indemnity in the event
of an H5/H7 LPAI outbreak and for the establishment of cooperative
agreements between APHIS and Official State Agencies to control H5/H7
outbreaks. It also sets out requirements for determining the value of
destroyed poultry and eggs, for cleaning and disinfecting affected
premises, for presenting claims, for distribution of payments, and for
developing an initial State response and containment plan.
The provisions of part 146 provide for testing and diagnostic
surveillance in commercial table-egg layers, meat-type chickens, and
meat-type turkeys. Part 56 includes those poultry in its provisions for
eradication of H5/H7 LPAI and payment of indemnity, and many of the
provisions of part 56 refer to provisions of part 146, such as the
State diagnostic surveillance plan for all poultry in the State or the
active surveillance programs for commercial poultry.
However, because part 56 is intended first and foremost to allow
APHIS to pay indemnity to help eradicate outbreaks of H5/H7 LPAI, the
regulations in part 56 allow us to pay indemnity to owners of breeding
poultry and both commercial and non-commercial poultry, such as poultry
grown for live bird markets. This represents a change from the
indemnity provisions developed at the July 2004 NPIP meeting, but we
expect that it will be necessary to pay indemnity for all types of
poultry in order to eradicate H5/H7 LPAI outbreaks.
As explained later in this document (see the section titled
``Payment of Indemnity'' below), commercial producers that are above
certain size standards will still have an indemnity-based incentive to
participate in the NPIP provisions in part 146, and they will still be
eligible to receive 100 percent indemnity if they do.
The specific provisions of parts 146 and 56 are discussed in more
detail below.
Control Program Provisions in 9 CFR Part 146
Definitions
Section 146.1 sets out definitions for the terms Administrator,
Animal and Plant Health Inspection Service (APHIS), Authorized Agent,
authorized laboratory, Department, domesticated, equivalent, Official
State Agency, person, Plan, program, Service, and State Inspector that
are substantively identical to the definitions of those terms in Sec.
145.1. In addition, Sec. 146.1 sets out definitions of State and
United States that are drawn directly from the Animal Health Protection
Act.
The other definitions below are new in part 146. For the
convenience of the reader, we have set out the definitions of Official
State Agency and Plan below.
Affiliated flock. A meat-type flock that is owned by or has an
agreement to participate in the Plan with a slaughter plant and that
participates in the Plan through that slaughter plant.
For meat-type poultry, the control program in part 146 is organized
around the participation of slaughter plants, which typically own the
flocks that are slaughtered at the plants. Affiliation with a slaughter
plant through an agreement can be a way for a flock not owned by a
slaughter plant to participate in the Plan. This issue is discussed in
more detail under the heading ``Participation'' later in this document.
Classification. A designation earned by participation in a Plan
program.
Commercial meat-type flock. All of the meat-type chickens or meat-
type turkeys on one farm. However, at the discretion of the Official
State Agency, 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 may be
considered as a separate flock.
We are allowing for groups of meat-type poultry to be considered
separate flocks if they have been segregated from other poultry on the
farm for 21 days in case H5/H7 LPAI infects one group of poultry on a
farm but not another one, and the Official State Agency determines that
biological security measures sufficient to prevent the transmission of
H5/H7 LPAI in place were adequate to prevent the transmission of H5/H7
LPAI between the two groups. (The H5 and H7 subtypes of LPAI can in
some cases have low enough virulence to make such measures practical,
although final judgment is up to the Official State Agency.) The 21-day
period is consistent with the new OIE guidelines regarding NAI
discussed earlier in this document. This provision will allow the
number of meat-type poultry that would be depopulated in the case of an
H5/H7 LPAI outbreak to be kept to a minimum if possible.
Commercial table-egg layer flock. All table-egg layers of one
classification in one barn or house.
Commercial table-egg layer premises. A farm containing contiguous
flocks of commercial table-egg layers under common ownership.
The regulations address commercial table-egg layers on the premises
level because a single commercial table-egg layer premises typically
contains several poultry houses with flocks of different ages.
H5/H7 low pathogenic avian influenza (LPAI). An infection of
poultry caused by an influenza A virus of H5 or H7 subtype that has an
intravenous pathogenicity index test in 6-week-old chickens less than
1.2 or any infection with influenza A viruses of H5 or H7 subtype for
which nucleotide sequencing has not demonstrated the presence of
multiple basic amino acids at the cleavage site of the hemagglutinin.
H5/H7 LPAI virus infection (infected). Poultry will be considered
to be infected with H5/H7 LPAI for the purposes of part 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
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.
The definitions of H5/H7 LPAI and H5/H7 LPAI infection thus provide
specific criteria for determining whether a bird is infected with H5/H7
LPAI. With one exception they are consistent with the OIE guidelines
regarding NAI that were discussed earlier in this document. The OIE
definition of NAI, which includes both HPAI and H5/H7 LPAI, mentions
detecting the virus or viral antigens or RNA in products derived from
poultry. However, only HPAI virus has been found in products derived
from poultry; research indicates that live LPAI virus is not found in
[[Page 56310]]
poultry meat or from other products derived from poultry. \6\
Therefore, we have not included that part of the OIE definition in our
definition of H5/H7 LPAI infection.
---------------------------------------------------------------------------
\6\ See David E. Swayne and Joan R. Beck, ``Experimental Study
to Determine if Low-Pathogenicity and High-Pathogenicity Avian
Influenza Viruses Can Be Present in Chicken Breast and Thigh Meat
Following Intranasal Virus Inoculation,'' Avian Diseases 49:81-85,
2005.
---------------------------------------------------------------------------
Official State Agency. The State authority recognized by the
Department to cooperate in the administration of the Plan.
Plan. The provisions of the National Poultry Improvement Plan
contained in part 146.
Poultry. Domesticated chickens and turkeys that are bred for the
primary purpose of producing eggs or meat.
The definition of poultry is similar to the definitions of that
term in Sec. 145.1 but has been adapted to refer specifically to the
types of poultry included in part 146.
Administration
Section 146.2 sets out the conditions under which the provisions of
part 146 are administered. These conditions are substantively identical
to those under which the Plan's provisions in part 145 for breeding
poultry are administered; we believe they will be effective for
commercial poultry as well.
Paragraph (a) of this section states that the Department cooperates
through a Memorandum of Understanding with Official State Agencies in
the administration of the Plan.
Paragraph (b) of this section states that the administrative
procedures and decisions of the Official State Agency are subject to
review by the Service (i.e., APHIS) and that the Official State Agency
shall carry out the administration of the Plan within the State
according to the applicable provisions of the Plan and the Memorandum
of Understanding.
Paragraph (c)(1) of this section allows an Official State Agency to
accept for participation a commercial table-egg layer flock or a
commercial meat-type flock (including an affiliated flock) located in
another participating State under a mutual understanding and agreement,
in writing, between the two Official State Agencies regarding
conditions of participation and supervision. If a flock is located in a
State that does not participate in the Plan, paragraph (c)(2) provides
that such a flock may participate with a participating State under a
mutual understanding and agreement, in writing, between the owner of
the flock and the Official State Agency regarding conditions of
participation and supervision. These provisions ensure that flocks are
able to participate in the Plan in States other than the State in which
they are located when such participation is desirable to facilitate
participation in the Plan. In particular, these provisions allow
affiliated flocks that are located in a State other than the one in
which the slaughter plant with which they are participating is located
to participate in the Plan in the State in which the slaughter plant is
located.
The Plan does not provide for slaughter plants to participate in a
State other than the State in which they are located, because the
sample collection that may take place at slaughter plants must be
overseen by the local Official State Agency.
Paragraph (d) of this section allows the Official State Agency of
any State to adopt regulations applicable to the administration of the
Plan in that State that further define the provisions of the Plan or
establish higher standards that are compatible with the Plan.
Paragraph (e) of this section requires that an authorized
laboratory of the NPIP follow the laboratory protocols outlined in 9
CFR part 147 when determining the status of a participating flock with
respect to an official Plan classification.
Paragraph (f) of this section states that the Official State Agency
will be responsible for making the determination to request Federal
assistance under 9 CFR part 56 in the event of an outbreak of H5/H7
LPAI. While the provisions of 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 (and described in
further detail later in this document) 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
regulations in 9 CFR part 56, by contrast, provide that APHIS may pay
indemnity for destroyed birds and eggs and for certain other
activities; because indemnity may be paid from Federal funds under
these regulations, all actions taken under part 56 are subject to APHIS
review and approval. Given this administrative structure, some Official
State Agencies may prefer to eradicate outbreaks of H5/H7 LPAI without
invoking APHIS assistance when it is feasible for them to do so. With
this provision and a similar provision in Sec. 56.2(c), the new H5/H7
LPAI control and indemnity regulations allow for this flexibility. If a
State decides that APHIS assistance is necessary, we will support that
State to the greatest extent our resources allow.
Participation
Section 146.3 sets out the conditions under which commercial table-
egg producers and commercial meat-type chicken and meat-type turkey
flocks and slaughter plants may participate in the Plan. These
provisions ensure that participants in the Plan comply with Plan
requirements.
For commercial meat-type chickens and meat-type turkeys, the
control program in part 146 is organized around the participation of
slaughter plants. This is because slaughter plants for commercial meat-
type chickens and meat-type turkeys are typically owned by the same
entity that owns the birds themselves. Thus, when slaughter plants
participate in the Plan, the owners of those slaughter plants are able
to ensure that the flocks from which meat-type chickens and meat-type
turkeys are sent to the slaughter plants meet the testing requirements
of the control program. Under the surveillance programs for meat-type
chickens and meat-type turkeys, slaughter plants have the option to
conduct surveillance either at the slaughter plant or in the flocks
that will eventually be sent to the slaughter plant.
Independently owned meat-type flocks may participate in the Plan by
becoming affiliated with a slaughter plant that participates in the
Plan. Owners of independently owned flocks participating in this manner
would have to either allow surveillance to be conducted at the
slaughter plant or conduct surveillance themselves in the flocks,
depending on how the slaughter plant participates in the Plan.
Since commercial table-egg layers are organized for production
purposes at the flock level, the control program provides for their
participation at the flock level.
Paragraph (a) of this section states that any table-egg producer
and any meat-type chicken or meat-type turkey producer or slaughter
plant may participate in the Plan when the producer or plant has
demonstrated, to the satisfaction of the Official State Agency, that
its facilities, personnel, and practices are adequate for carrying out
the relevant special provisions of this part and has signed an
agreement with the Official State Agency to comply with the relevant
special provisions in subparts B, C, or D of part 146. (We use the
phrase ``relevant special provisions'' because some commercial poultry
flocks and slaughter plants that may participate in the Plan
[[Page 56311]]
are not required to comply with the special provisions due to size
requirements. These provisions are discussed in greater detail later in
this document.)
Paragraph (b) of this section requires that each participant comply
with the Plan throughout the operating year, or until released by the
Official State Agency.
Paragraph (c) of this section requires that a participating
slaughter plant participate with all of the meat-type chicken and/or
meat-type turkey flocks that are processed at the facility, including
affiliated flocks. Only if all the flocks participating at a slaughter
plant have been produced under Plan-approved biosecurity controls and
surveillance programs can the plant be considered to be participating
in the Plan, according to the OIE guidelines. It also requires that
affiliated flocks participate through a written agreement with a
participating slaughter plant that is approved by the Official State
Agency. This requirement ensures that the Official State Agency is
aware of all the flocks participating with any slaughter plant and has
an opportunity to approve the terms of their participation.
Paragraph (d) of this section states that participation in the Plan
shall entitle the participant to use the Plan participant emblem. The
Plan participant emblem is often used as a marketing tool by
participants, so it is important to include a statement in the
regulations specifically allowing its use only by Plan participants.
Paragraph (e) of this section states that participation in the NPIP
by commercial table-egg layers is limited to 2 years after the
effective date of this interim rule unless the majority of the
commercial table-egg layer delegates vote to continue the program in
accordance with subpart E of 9 CFR part 147 at the National Plan
Conference. We have included this provision because, at the July 2004
NPIP meeting in San Francisco, CA, the commercial table-egg layer
industry indicated that it wanted to make its participation in the Plan
conditional. If that industry decides at a National Plan Conference
after the publication of this interim rule that it wants to continue
its participation in the NPIP, we will remove paragraph Sec. 146.3(e)
from the regulations. If that industry decides that it does not want to
continue its participation, we will amend part 146 to remove the
special provisions for table-egg layers in subpart B of that part and
will remove references to table-egg layers in subpart A. We would then
evaluate the available regulatory options to ensure that the voluntary
control program could continue to provide an adequate level of
surveillance for H5/H7 LPAI.
General Provisions for All Participating Flocks and Slaughter Plants
Section 146.4 sets out general provisions with which all flocks and
slaughter plants that participate in the Plan must comply.
Paragraph (a) of this section requires that records that establish
the identity of products handled be maintained in a manner satisfactory
to the Official State Agency. Adequate recordkeeping will allow any
necessary investigations to be conducted more efficiently.
Paragraph (b) of this section states that material that is used to
advertise products shall be subject to inspection by the Official State
Agency at any time. Paragraph (c) states that advertising must be in
accordance with the Plan and applicable rules and regulations of the
Official State Agency and the Federal Trade Commission. Paragraph (c)
further states that a participant advertising products as being of any
official classification may include in their advertising reference to
associated or franchised slaughter or production facilities only when
such facilities produce products of the same classification. These
provisions ensure that Plan participation is not misrepresented for
marketing purposes.
Paragraph (d) states that each Plan participant shall be assigned a
permanent approval number by APHIS. This number, prefaced by the
numerical code of the State, will be the official approval number of
the participant and may be used on each certificate, invoice, shipping
label, or other document used by the participant in the sale of the
participant's products. Each Official State Agency which requires an
approval number for out-of-State participants to ship into its State
shall honor this number. The assignment of a permanent approval number
helps in tracking Plan participation. In addition, the requirement that
Official State Agencies honor the permanent approval numbers assigned
to participants when administering State import requirements helps
simplify the interstate movement process for producers.
Specific Provisions for Participating Flocks
Section 146.5 requires that:
Participating flocks, and all equipment used in connection
with the flocks, be separated from non-participating flocks in a manner
acceptable to the Official State Agency; and
Poultry equipment, and poultry houses and the land in the
immediate vicinity thereof, be kept in sanitary condition as
recommended in Sec. 147.21(c).
These requirements are similar to requirements in Sec. 145.5(a).
The provision requiring that participating flocks be separated from
non-participating flocks ensures that participating flocks are not
subject to the higher risks of disease presence associated with non-
participating flocks. The requirement that poultry equipment, and
poultry houses and the land in the immediate vicinity thereof, be kept
in sanitary condition will help to mitigate any risks of disease for
participating flocks.
Specific Provisions for Participating Slaughter Plants
Section 146.6 sets out specific provisions for participating
slaughter plants. These provisions are:
Only meat-type chicken and meat-type turkey slaughter
plants that are under continuous inspection by the Food Safety and
Inspection Service of the U.S. Department of Agriculture or under State
inspection that the Food Safety Inspection Service has recognized as
equivalent to federal inspection may participate in the Plan.
To participate in the Plan, meat-type chicken and meat-
type turkey slaughter plants must follow the relevant special
provisions for sample collection and flock monitoring in Sec. Sec.
146.33(a) and 146.43(a), respectively, unless they are exempted from
the special provisions under Sec. Sec. 146.32(b) or 146.42(b),
respectively. The specific provisions require routine monitoring for
H5/H7 LPAI of all flocks slaughtered at the slaughter plants.
Testing for meat-type chickens and meat-type turkeys may be
performed either at the slaughter plant or at the flock level. As
discussed earlier in this document, slaughter plants for commercial
meat-type chickens and meat-type turkeys are typically owned by the
same entity that owns the birds themselves; thus, when slaughter plants
participate in the Plan, the owners of those slaughter plants are able
to ensure that the flocks from which meat-type chickens and meat-type
turkeys are sent to the slaughter plants meet the testing requirements
in Sec. Sec. 146.33(a) and 146.43(a). Affiliated flocks that are not
owned by the slaughter plant with which they participate will agree on
how testing is to be conducted in the written agreement between the
affiliated flock and the slaughter plant. On the other hand, table-egg
layers are tested at the flock level either within 30 days of
[[Page 56312]]
disposal or once every 12 months. (The provisions for monitoring of
table-egg layer flocks are described in more detail under the heading
``Subpart B--Special Provisions for Commercial Table-Egg Layer Flocks''
later in this document.)
Terminology and Classification
Section 146.7 states that classification terms and illustrative
designs associated with those terms may only be used by participants in
the Plan and may only be used to describe products that have met all
the specific requirements of those classifications. Section 146.8
states that participating slaughter plants shall be designated as
``U.S. H5/H7 Avian Influenza Monitored,'' and all Official State
Agencies shall be notified by APHIS of additions, withdrawals, and
changes in classification. Section 146.9 sets out the various
classifications that may be earned by participating flocks (including
affiliated flocks), products produced from those flocks, and States,
and provides illustrative designs corresponding to those
classifications that may be used by those flocks and States. The
organization, language, and designs in these sections are modeled on
those contained in similar provisions in Sec. Sec. 145.8 through
145.10.
The specific testing requirements for each type of poultry in 9 CFR
part 146 are discussed in detail later in this document.
Supervision
Section 146.10 authorizes the Official State Agency to designate
qualified persons as Authorized Agents to do the sample collecting
provided for in Sec. 146.13, which sets out sample collection
procedures for the blood test for AI. It also states that the Official
State Agency may employ or authorize qualified persons as State
Inspectors to perform the selecting and testing of participating flocks
and to perform the official inspections necessary to verify compliance
with the requirements of the Plan. Under this section, the authorities
issued to Authorized Agents and State Inspectors are subject to
cancellation by the Official State Agency on the grounds of
incompetence or failure to comply with the provisions of the Plan or
regulations of the Official State Agency. Such actions shall not be
taken until thorough investigation has been made by the Official State
Agency and the authorized person has been given notice of the proposed
action and the basis thereof and an opportunity to present his or her
views. These provisions allow the Official State Agency to designate
persons to administer the various provisions of the Plan and to
withdraw that designation on the grounds of incompetence or failure to
comply with the provisions of the Plan or regulations of the Official
State Agency.
Inspections
All slaughter plants and flocks of commercial poultry that
participate in the Plan must comply with the inspection requirements of
Sec. 146.11. The requirements are:
Each participating slaughter plant shall 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.
On-site inspections of flocks and premises will be
conducted if a State Inspector determines that a breach of testing has
occurred for the Plan programs for which the flocks are certified.
The official H5/H7 LPAI testing records of all
participating flocks and slaughter plants shall be examined annually by
a State Inspector. Official H5/H7 LPAI testing records shall be
maintained for 3 years.
Compliance with these auditing and inspection requirements will
serve to establish that the participating flock or slaughter plant is
complying with the surveillance requirements of the Plan. These
requirements are also important because, as discussed earlier in this
document, participating table-egg layer premises with fewer than 75,000
birds and participating slaughter plants that slaughter fewer than
200,000 meat-type chickens per week or 2 million meat-type turkeys per
year are exempt from the special provisions, including the active
surveillance requirements, for table-egg layer premises, meat-type
chicken slaughter plants, and meat-type turkey slaughter plants in
subparts B, C, and D, respectively, of part 146. However, participating
table-egg layer premises with fewer than 75,000 birds and participating
slaughter plants that slaughter fewer than 200,000 meat-type chickens
per week or 2 million meat-type turkeys per year must be audited and,
if necessary, inspected according to this section in order to
participate in the Plan, which will help to ensure that they are
complying with the requirements of subpart A of part 146.
Debarment From Participation
Section 146.12 describes the procedures by which participants in
the Plan may be debarred from participation. Under this section,
participants in the Plan who, after investigation by the Official State
Agency or its representative, are notified in writing of their apparent
noncompliance with the Plan provisions or regulations of the Official
State Agency shall be afforded a reasonable time, as specified by the
Official State Agency, within which to demonstrate or achieve
compliance. If compliance is not demonstrated or achieved within the
specified time, the Official State Agency may debar the participant
from further participation in the Plan for such period, or
indefinitely, as the Official State Agency may deem appropriate. The
debarred participant shall be afforded notice of the bases for the
debarment and opportunity to present his or her views with respect to
the debarment in accordance with procedures adopted by the Official
State Agency. The Official State Agency shall thereupon decide whether
the debarment order shall continue in effect. Such decision shall be
final unless the debarred participant, within 30 days after the
issuance of the debarment order, requests the Administrator of APHIS to
determine the eligibility of the debarred participant for participation
in the Plan. In such an event, the Administrator shall determine the
matter de novo in accordance with the rules of practice in 7 CFR part
50.
Testing
Section 146.13 sets out requirements relating to testing samples
for H5/H7 LPAI. Either egg yolk or blood samples may be used for
testing.
Paragraph (a) of this section contains requirements for sample
collection and preparation. Paragraph (a)(1) requires that egg yolk
samples be collected and prepared in accordance with the requirements
in Sec. 147.8. Prior to the publication of this interim rule, Sec.
147.8, ``Procedures for preparing egg yolk samples for diagnostic
tests,'' had referred only to testing for Mycoplasma gallisepticum and
M. synoviae. We believe the procedures for preparation of egg yolk
samples in this section will work equally well for preparing egg yolk
samples for testing for H5/H7 LPAI. Accordingly, we are amending the
introductory text of Sec. 147.8 to indicate that the procedure may be
used for preparing samples for testing for the U.S. H5/H7 AI Monitored
Classifications in part 146. We are also amending paragraph (b)(7) of
that section to indicate that subsequent testing for H5/H7 LPAI must be
performed in accordance with the requirements in paragraph (b) of Sec.
146.13.
Paragraph (a)(2) contains specific requirements for collection and
storage of blood samples to be tested for LPAI, including when and how
blood should
[[Page 56313]]
be collected from birds, when and how the sample should be
refrigerated, and what measures should be taken to ensure that the
sample can be reliably tested. It also states that blood samples must
be drawn by an Authorized Agent or State Inspector, as designated in
accordance with Sec. 146.10. The details of these requirements are set
out in the rule portion of this document.
Paragraph (b) of Sec. 146.13 sets out the requirements for testing
for AI. Under this paragraph, the official tests for AI are the agar
gel immunodiffusion (AGID) test and the enzyme-linked immunosorbent
assay (ELISA). Both tests can be used on either egg yolk or blood
samples. The procedures for testing for avian influenza using AGID and
ELISA are set out in Sec. 147.9.
The ELISA, a rapid, sensitive test, is typically used to perform
initial testing on samples. Any samples that are found to be positive
using ELISA must be confirmed using the AGID test, which is more time-
consuming but provides more accurate results. Any samples that are
found to be positive by AGID must be further tested and subtyped by
Federal Reference Laboratories using the hemagglutination inhibition
test, which can provide a definitive diagnosis. Final judgment as to
whether a sample is positive for H5/H7 LPAI may be based upon further
sampling or culture results. The official determination of a flock as
positive for H5/H7 LPAI may be made only by the National Veterinary
Services Laboratories in Ames, IA (NVSL).
The AGID and ELISA tests must be conducted using antigens or test
kits approved by APHIS. Test kits must be licensed by APHIS and
approved by the Official State Agency and must be used in accordance
with the recommendations of the producer or manufacturer.
Diagnostic Surveillance Program for H5/H7 LPAI
Section 146.14 provides for the diagnostic surveillance program
mentioned above under the heading ``Overall Approach of Voluntary
Control and Indemnity Program.'' It requires the Official State Agency
to develop a diagnostic surveillance program for H5/H7 LPAI for all
poultry (not just commercial poultry) in the State. The exact
provisions of the program are at the discretion of the States. APHIS
will use the standards below in assessing individual State plans for
adequacy, including the specific provisions that the State developed.
The standards should be used by States in developing those plans.
The regulations in this section require that AI 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/H7 LPAI directly to APHIS) 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.
We believe any plan that adequately fulfills these guidelines will
ensure that possible infections of H5/H7 LPAI are promptly reported to
responsible State authorities, which can then take any further action
that may be required.
The diagnostic surveillance plan performance standards specifically
mention that H5/H7 LPAI should be reported directly to APHIS. APHIS is
the governmental organization authorized to represent the United States
to the OIE; we have included this provision to ensure that only APHIS,
rather than any individual State, makes a report of H5/H7 LPAI to the
OIE.
Subpart B--Special Provisions for Commercial Table-Egg Layer Flocks
Subpart B (Sec. Sec. 146.21 through 146.24) of part 146 provides
special provisions of the Plan with which participating table-egg layer
flocks and States must comply in order to be eligible for the U.S.
Avian Influenza Monitored classification.
Section 146.21, ``Definitions,'' sets out a definition of table-egg
layer that reads: ``A domesticated chicken grown for the primary
purpose of producing eggs for human consumption.''
Section 146.22, ``Participation,'' states that participating flocks
of table-egg layers must comply both with the applicable general
provisions of subpart A of part 146 and the special provisions of
subpart B of part 146. However, the section exempts participating
table-egg laying premises with fewer than 75,000 birds from the special
provisions of subpart B.
Section 146.23, ``Terminology and classification; flocks and
products,'' sets out the active surveillance requirements for
participating commercial table-egg layer flocks. The active
surveillance requirements in Sec. 146.23(a) are intended for table
egg-laying premises of 75,000 birds or more. However, producers of
smaller table-egg layer flocks may wish to participate in the NPIP to
use its seal of approval as a marketing tool. Therefore, smaller table-
egg layer flocks are eligible to participate in the NPIP. We believe
that diagnostic surveillance in accordance with Sec. 146.14 and
inspections in accordance with Sec. 146.11, which are required in the
general provisions in subpart A, are adequate to determine whether H5/
H7 LPAI is present on such premises.
The indemnity provisions we are establishing in part 56 provide
authority to pay indemnity for only 25 percent of costs to any table-
egg layer premises that has 75,000 or more birds and that does not
participate in the active surveillance described in Sec. 146.23(a). As
discussed earlier, the 75,000-bird standard is consistent with the
American Egg Board's definition of commercial egg producers and will
concentrate resources on testing flocks that comprise a relatively high
percentage of the total U.S. population of commercial table-egg layers.
Under paragraph (a) of Sec. 146.23, a table egg-layer flock is
eligible for the U.S. H5/H7 Avian Influenza Monitored designation if it
meets one of the following requirements:
It is a table-egg layer flock in which a minimum of 11
birds or egg samples from the same flock have been tested negative for
antibodies to the H5/H7 subtypes of avian influenza within 30 days
prior to disposal;
It is a table-egg layer flock in which a minimum of 11
birds or egg samples from the same flock have been tested negative for
antibodies to the H5/H7 subtypes of avian influenza within a 12-month
period; or
The flock has an ongoing active and diagnostic
surveillance program for H5/H7 LPAI in which the number of birds or egg
samples tested is equivalent to the number required by one of the first
two options. Such a program must be approved by the Official State
Agency and APHIS.
Both of the first two testing requirements are sufficient to
establish commercial table-egg layer flocks as free of H5/H7 LPAI at a
95 percent confidence interval for a 25 percent infection rate, and
both are consistent with the new OIE guidelines for surveillance of NAI
that were discussed earlier in this document.\7\ These testing
[[Page 56314]]
requirements are designed to ensure that participating flocks are
tested at least once each operating year. Most laying flocks are in lay
for almost 2 years and are then disposed of; the first testing
requirement ensures that if a participating flock is tested once and
then disposed of prior to the passing of a second 12-month period, it
will be tested again prior to disposal.
---------------------------------------------------------------------------
\7\ This plan, as well as the plans for meat-type chickens and
meat-type turkeys discussed later in this document, was developed in
accordance with the OIE guidelines in the Terrestrial Animal Health
Code Chapter 3.8.9, ``Guidelines for surveillance of avian
influenza,'' and in accordance with Dr. Victor Beal's reference
Regulatory Statistics (sixth edition, June 1983). For details of the
testing plan, please contact the person listed under FOR FURTHER
INFORMATION CONTACT.
---------------------------------------------------------------------------
Any ongoing active and diagnostic surveillance program that is
approved by the Official State Agency and APHIS would have to test a
number of birds or egg samples equivalent to the other two options, but
this by itself would not be sufficient to secure approval for the
program; the Official State Agency and APHIS would have to agree that
the detailed testing plan for the alternate program is sufficient to
establish a level of confidence for the detection of AI that is
equivalent to that of the other two options. Allowing owners of
participating flocks to develop an alternative ongoing active and
diagnostic surveillance program of equivalent efficacy will give the
flock owners some flexibility.
Section 146.24, ``Terminology and classification; States,'' sets
out the requirements for States to be eligible for the U.S. H5/H7 Avian
Influenza Monitored State, Layers classification. These requirements
are contained in paragraph (a)(1) of Sec. 146.24. The requirements
are:
All table-egg layer flocks in production within the State
that are not exempt from the special provisions of subpart B under
Sec. 146.22 are classified as U.S. H5/H7 Avian Influenza Monitored
under Sec. 146.23(a);
All egg-type chicken breeding flocks in production within
the State are classified as U.S. Avian Influenza Clean under Sec.
145.23(h);
All persons performing poultry disease diagnostic service
within the State must be required to report to the Official State
Agency, within 24 hours, the source of all table-egg layer specimens
that were deemed positive on an official test for AI, as designated in
Sec. 146.13(a);
All table-egg layer specimens that were deemed positive on
an official test for AI, as designated in Sec. 146.13(a) must be sent
to an authorized laboratory for subtyping; and
All table-egg layer flocks within the State found to be
infected with H5/H7 LPAI must be quarantined, in accordance with an
initial State response and containment plan as described in 9 CFR part
56 and under the supervision of the Official State Agency. APHIS may
revoke this classification if:
There is a discontinuation of any of the above conditions;
Repeated outbreaks of H5/H7 LPAI occur in table-egg layer
flocks; or
An infection spreads from the originating premises.
APHIS will not revoke a classification until a thorough
investigation has been made by APHIS and the Official State Agency has
been given an opportunity for a hearing in accordance with rules of
practice adopted by the Administrator, as described in Sec. 146.12.
(The language governing revocation of classification is similar to
language used to describe revocation of State classifications in part
145.)
It should be noted that participation in the U.S. H5/H7 Avian
Influenza Monitored State, Layers program is not a precondition for
State participation in the Plan; rather, it is an optional program that
States may pursue if an Official State Agency and the table-egg layer
owners in that State wish to use the designation of U.S. H5/H7 Avian
Influenza Monitored State, Layers.
Subpart C--Special Provisions for Meat-Type Chicken Slaughter Plants
Subpart C (Sec. Sec. 146.31 through 146.33) of part 146 provides
special provisions of the Plan with which participating meat-type
chicken slaughter plants must comply in order to be eligible for the
U.S. H5/H7 Avian Influenza Monitored classification. We do not believe
it is necessary to provide for a U.S. H5/H7 Avian Influenza Monitored
State classification for meat-type chickens at this time. However, 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.
Section 146.31, ``Definitions,'' sets out a definition of meat-type
chicken that reads: ``A domesticated chicken grown for the primary
purpose of producing meat, including but not limited to broilers,
roasters, fryers, and cornish'' and a definition of meat-type chicken
slaughter plant that reads: ``A meat-type chicken slaughter plant that
is federally inspected or under State inspection that the Food Safety
Inspection Service has recognized as equivalent to federal
inspection.'' It also defines shift as: ``The working period of a group
of employees who are on duty at the same time.''
Section 146.32, ``Participation,'' states that participating meat-
type chicken slaughter plants shall comply with applicable general
provisions of subpart A of part 146 and the special provisions of
subpart C. However, the section exempts participating meat-type chicken
slaughter plants that slaughter fewer than 200,000 meat-type chickens
in an operating week from the special provisions of subpart C.
Section 146.33, ``Terminology and classification; meat-type chicken
slaughter plants,'' sets out the active surveillance requirements for
participating commercial meat-type chicken slaughter plants. The active
surveillance requirements in Sec. 146.33 are intended for meat-type
chicken slaughter plants that slaughter 200,000 or more meat-type
chickens in an operating week. However, smaller meat-type chicken
slaughter plants are eligible to participate in the NPIP. We believe
that diagnostic surveillance in accordance with Sec. 146.14 and
inspections in accordance with Sec. 146.11, which are required in the
general provisions in subpart A, are adequate to determine whether H5/
H7 LPAI is present on such premises.
The indemnity provisions we are establishing in part 56 provide
authority to pay indemnity for only 25 percent of costs to owners of
meat-type chicken flocks that participate in the Plan through a meat-
type chicken slaughter plant that slaughters 200,000 or more meat-type
chickens in an operating week and that does not participate in the
active surveillance described in Sec. 146.33(a). As discussed earlier,
the standard of slaughtering 200,000 or more meat-type chickens in an
operating week is consistent with Watt Publishing Companies' listing of
commercial meat-type chicken slaughter operations and will concentrate
resources on testing meat-type chickens associated with slaughter
plants that slaughter a relatively high percentage of the total U.S.
population of commercial meat-type chickens.
Under paragraph (a) of Sec. 146.33, a meat-type chicken slaughter
plant is eligible for the U.S. H5/H7 Avian Influenza Monitored
designation if it meets one of the following requirements:
A minimum of 11 birds per shift are tested negative for
antibodies to H5/H7 LPAI at slaughter. However, with the approval of
the Official State Agency, fewer than 11 birds per shift may be tested
for any given shift if the total number of birds tested during the
[[Page 56315]]
operating month is equivalent to testing 11 birds per shift;
The plant accepts only meat-type chickens from flocks
where a minimum of 11 birds have been tested negative for antibodies to
H5/H7 LPAI no more than 21 days prior to slaughter; or
The plant has an ongoing active and diagnostic
surveillance program for H5/H7 LPAI in which the number of birds tested
is equivalent to the number required by one of the first two options.
Such a program must be approved by the Official State Agency and APHIS.
Both of the first two of these testing requirements are sufficient
to establish the commercial meat-type chicken slaughter plants as free
of H5/H7 LPAI at a 95 percent confidence interval for a 25 percent
infection rate, and both are consistent with the new OIE guidelines for
surveillance of NAI that were discussed earlier in this document.
Allowing participating slaughter plants to choose between them will
give the slaughter plants some flexibility. The first option provides
for occasional variances below 11 birds per shift because occasional
sample collection problems are likely to arise at slaughter plants; as
long as the Official State Agency approves, testing more birds during
other shifts so that the number of birds tested per month is equivalent
to testing 11 birds per shift will provide adequate surveillance.
Any ongoing active and diagnostic surveillance program that is
approved by the Official State Agency and APHIS would have to test a
number of birds equivalent to the other two options, but this by itself
would not be sufficient to secure approval for the program; the
Official State Agency and APHIS would have to agree that the detailed
testing plan for the alternate program is sufficient to establish a
level of confidence for the detection of AI that is equivalent to that
of the other two options. Allowing participating slaughter plants to
develop an alternative ongoing active and diagnostic surveillance
program of equivalent efficacy will give the plants some additional
flexibility.
Subpart D--Special Provisions for Meat-Type Turkeys
Subpart D (Sec. Sec. 146.41 through 146.44) of part 146 provides
special provisions of the Plan with which participating producers and
States must comply in order to be eligible for the U.S. H5/H7 Avian
Influenza Monitored classification.
Section 146.41, ``Definitions,'' sets out a definition of meat-type
turkey that reads: ``A domesticated turkey grown for the primary
purpose of producing meat.'' It also sets out a definition of meat-type
turkey slaughter plant that reads: ``A meat-type turkey slaughter plant
that is federally inspected or under State inspection that the Food
Safety Inspection Service has recognized as equivalent to federal
inspection.''
Section 146.42, ``Participation,'' states that participating meat-
type turkey slaughter plants shall comply with applicable general
provisions of subpart A of part 146 and the special provisions of
subpart D. However, the section exempts meat-type turkey slaughter
plants that slaughter fewer than 2 million meat-type turkeys in a 12-
month period from the special provisions of subpart D.
Section 146.43, ``Terminology and classification; meat-type turkey
slaughter plants,'' sets out the active surveillance requirements for
participating commercial meat-type turkey slaughter plants. The active
surveillance requirements in Sec. 146.43 are intended for meat-type
turkey slaughter plants that slaughter 2 million or more meat-type
turkeys in a 12-month period. However, smaller meat-type turkey
slaughter plants are eligible to participate in the NPIP. We believe
that diagnostic surveillance in accordance with Sec. 146.14 and
inspections in accordance with Sec. 146.11, which are required in the
general provisions in subpart A, are adequate to determine whether H5/
H7 LPAI is present on such premises.
The indemnity provisions we are establishing in part 56 provide
authority to pay indemnity for only 25 percent of costs to owners of
meat-type turkey flocks that participate in the Plan through a meat-
type turkey slaughter plant that slaughters 2 million or more meat-type
turkeys in a 12-month period and that does not participate in the
active surveillance described in Sec. 146.33(a). As discussed earlier,
the standard of slaughtering 2 million or more meat-type turkeys in a
12-month period is consistent with Watt Publishing Companies' listing
of commercial meat-type turkey slaughter operations and will
concentrate resources on testing meat-type turkeys associated with
slaughter plants that slaughter a relatively high percentage of the
total U.S. population of commercial meat-type turkeys.
Under paragraph (a)(1) of Sec. 146.43, a meat-type turkey
slaughter plant is eligible for the U.S. H5/H7 Avian Influenza
Monitored designation if it meets one of the following requirements:
It is a meat-type turkey slaughter plant at which a sample
of a minimum of 60 birds has tested negative each month for antibodies
to type A avian influenza virus. Positive samples shall be further
tested by an authorized laboratory using the hemagglutination
inhibition test to detect antibodies to the hemagglutinin subtypes H5
and H7 when more than 4 months of age and prior to the onset of
production. It is recommended that samples be collected from flocks
over 10 weeks of age with respiratory signs such as coughing, sneezing,
snicking, sinusitis, or rales; depression; or decreases in food or
water intake; or
The plant has an ongoing active and diagnostic
surveillance program for H5/H7 LPAI in which the number of birds tested
is equivalent to the number required by the option directly above. Such
a program must be approved by the Official State Agency and APHIS.
Under the first testing requirement, turkeys may be tested either
on the flock level or at the slaughter plant; existing State LPAI
control programs, which may be used as a basis for meeting the
requirements of this program, typically require testing in one location
or the other. If turkeys are tested at the slaughter plant, it may be
more difficult to determine whether they have clinical symptoms that
can indicate the presence of AI, although it is still possible. To
accommodate testing at both locations, we have indicated that turkeys
with clinical symptoms should be tested if possible; however, if no
turkeys can be determined to have clinical symptoms, any turkeys may be
tested to fulfill the requirement.
The first testing requirement is sufficient to establish the meat-
type turkey slaughter plants as free of H5/H7 LPAI at a 95 percent
confidence interval for a 25 percent infection rate and is consistent
with the new OIE guidelines for surveillance of NAI that were discussed
earlier in this document. In addition, the recommendation that turkeys
with clinical symptoms, rather than turkeys selected at random, be
tested for H5/H7 LPAI could further improve the results of the testing.
Any ongoing active and diagnostic surveillance program that is
approved by the Official State Agency and APHIS would have to test a
number of birds equivalent to the first requirement, but this by itself
would not be sufficient to secure approval for the program; the
Official State Agency and APHIS would have to agree that the detailed
testing plan for the alternate program is sufficient to establish a
level of confidence for the detection of AI that is equivalent to that
of the first requirement. Allowing participating slaughter plants to
develop an
[[Page 56316]]
alternative ongoing active and diagnostic surveillance program of
equivalent efficacy will give the plants some flexibility.
Section 146.44, ``Terminology and classification; States,'' sets
out the requirements for States to be eligible for the U.S. H5/H7 Avian
Influenza Monitored State, Turkeys classification. These requirements
are contained in paragraph (a)(1) of Sec. 146.44. The requirements
are:
All meat-type turkey slaughter plants within the State
that are not exempt from the special provisions of subpart D under
Sec. 146.42 are classified as U.S. H5/H7 Avian Influenza Monitored
under Sec. 146.43(a);
All turkey breeding flocks in production within the State
are classified as U.S. H5/H7 Avian Influenza Clean under Sec.
145.43(g);
All persons performing poultry disease diagnostic service
within the State must be required to report to the Official State
Agency, within 24 hours, the source of all meat-type turkey specimens
that were deemed positive on an official test for AI, as designated in
Sec. 146.13(a);
All meat-type turkey specimens that were deemed positive
on an official test for AI, as designated in Sec. 146.13(a), must be
sent to an authorized laboratory for subtyping; and
All meat-type turkey flocks within the State that are
found to be infected with the H5/H7 subtypes of avian influenza must be
quarantined, in accordance with an initial State response and
containment plan as described in part 56 and under the supervision of
the Official State Agency.
APHIS may revoke this classification if:
There is a discontinuation of any of the above conditions;
Repeated outbreaks of the H5/H7 subtypes of avian
influenza occur in meat-type turkey flocks; or
An infection spreads from the originating premises.
The conditions under which APHIS will revoke a classification are
identical to those in Sec. 146.24(b) for revoking the classification
of U.S. H5/H7 Avian Influenza Monitored State, Layers.
It should be noted that participation in the U.S. H5/H7 Avian
Influenza Monitored State, Turkeys program is not a precondition for
State participation in the Plan; rather, it is an optional program that
States may pursue if an Official State Agency and the meat-type turkey
slaughter plants in that State wish to use the designation of U.S. H5/
H7 Avian Influenza Monitored State, Turkeys.
Emergency Response and Compensation Provisions in 9 CFR Part 56
Definitions
Section 56.1 sets out definitions for the terms Animal and Plant
Health Inspection Service (APHIS), classification, commercial meat-type
flock, commercial table-egg layer flock, commercial table-egg layer
premises, Department, domesticated, H5/H7 low pathogenic avian
influenza (LPAI), H5/H7 LPAI virus infection (infected), meat-type
chicken, meat-type turkey, Official State Agency, State, table-egg
layer, and United States that are identical to the definitions of those
terms in part 146.
The definition of Administrator in part 56 reads: ``The
Administrator, Animal and Plant Health Inspection Service, or any other
employee of the Animal and Plant Health Inspection Service delegated to
act in the Administrator's stead.'' The definition of Administrator in
part 146 does not limit the people who may be delegated to act in the
Administrator's stead to employees of APHIS. We have included this
limitation in part 56 because the Administrator is authorized to pay
compensation under Sec. 56.3, and APHIS must have the final authority
to make a decision on whether to pay compensation. The definition of
Plan in part 56 refers to the provisions of the NPIP in parts 145, 146,
and 147.
The definition of poultry in part 56 reads: ``Domesticated fowl,
including chickens, turkeys, ostriches, emus, rheas, cassowaries,
waterfowl, and game birds, except doves and pigeons, which are bred for
the primary purpose of producing eggs or meat.'' For reasons discussed
earlier in this document, this definition includes poultry for which
NPIP AI control programs do not exist in parts 145 or 146.
The following definitions are unique to part 56:
Breeding flock. A flock that is composed of stock that has been
developed for commercial egg or meat production and is maintained for
the principal purpose of producing chicks for the ultimate production
of eggs or meat for human consumption. (Section 145.1 includes
definitions of primary breeding flock and multiplier breeding flock;
for the purposes of determining eligibility for compensation, it is not
necessary to make such a distinction, although whether a bird is a
member of a primary or multiplier breeding flock would be taken into
account when determining its fair market value through appraisal.)
Cooperating State Agency. Any State authority recognized by the
Department to cooperate in the administration of the provisions of this
part 56. This may include the State animal health authority or the
Official State Agency. We are including this definition because 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 would cooperate with the State animal health authority to
eradicate an H5/H7 LPAI outbreak and pay indemnity under part 56.
Flock plan. A written flock management agreement developed by APHIS
and the Official State Agency with input from the flock owner and other
affected parties. Under this definition, 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. (This definition
is adapted from the definition of herd plan in the chronic wasting
disease control and indemnity regulations in 9 CFR part 55.)
H5/H7 LPAI exposed. At risk of developing H5/H7 LPAI because of
association with birds or poultry infected with H5/H7 LPAI, excrement
from birds or poultry infected with H5/H7 LPAI, or other material
touched by birds or poultry infected with H5/H7 LPAI, or because there
is reason to believe that association has occurred with H5/H7 LPAI or
vectors of H5/H7 LPAI, as determined by the Cooperating State Agency
and confirmed by APHIS.
We are requiring that the determination that poultry are H5/H7 LPAI
exposed be made by the Cooperating State Agency in order to be
consistent with the other provisions of the NPIP, including the new
provisions for commercial poultry, which require State Inspectors and
Authorized Agents designated by the Official State Agency to collect
and test samples. (As noted earlier, eradication efforts for poultry
not included in the NPIP could be conducted in cooperation with the
State animal health authority.) However, since the final determination
on whether to pay indemnity for birds destroyed due to H5/H7 LPAI will
be
[[Page 56317]]
made by the APHIS Administrator, we are requiring that this
determination be confirmed by APHIS.
Mortgage. Any mortgage, lien, or other security or beneficial
interest held by any person other than the one claiming indemnity for
the destruction of poultry or eggs due to H5/H7 LPAI.
Official appraiser (APHIS official appraiser, State official
appraiser). A person authorized by APHIS to appraise poultry for the
purposes of this part. A State official appraiser is selected by a
State and authorized by APHIS.
Secretary. The Secretary of the United States Department of
Agriculture, or any officer or employee of the Department delegated to
act in the Secretary's stead.
Cooperation With States
Section 56.2 states that the Administrator of APHIS has been
delegated the authority to cooperate with Cooperating State Agencies in
the eradication of LPAI. The section provides that cooperation may
include, but is not necessarily limited to, the following activities:
Payment to Cooperating State Agencies for surveillance and
monitoring associated with poultry that have been infected with or
exposed to H5/H7 LPAI;
Transfer of vaccine for H5/H7 LPAI to Cooperating State
Agencies, if provided for in the initial State response and containment
plan developed by the Official State Agency and approved by APHIS under
Sec. 56.10; and
Payment for vaccine administration by Cooperating State
Agencies, if provided for in the initial State response and containment
plan.
APHIS is authorized to transfer vaccine for disease control
purposes, but current regulations do not provide for payment of
compensation to Cooperating State Agencies for their use of vaccine.
However, any costs Cooperating State Agencies incur in administering
the transferred vaccine, such as labor on the part of Cooperating State
Agency employees to give the vaccine to poultry, will be eligible for
payment by APHIS.
Paragraph (b) of this section sets out conditions for payment and
vaccine transfer under Sec. 56.2. Paragraph (b)(1) requires that any
payment made to Cooperating State Agencies for surveillance,
monitoring, and vaccine administration after detection of H5/H7 LPAI be
made through a cooperative agreement between the Cooperating State
Agency and APHIS. It further states that the payment for which the
Cooperating State Agency is eligible will be determined in the
cooperative agreement.
Paragraph (b)(1)(i) provides that, for any State that participates
in the diagnostic surveillance program for H5/H7 LPAI in part 146 and
has an initial State response and containment plan for H5/H7 LPAI that
is approved by APHIS, the cooperative agreement will provide that the
Cooperating State Agency is eligible for payment of 100 percent of the
costs of surveillance and monitoring and 100 percent of the costs of
vaccine administration, as determined in the cooperative agreement.
Paragraph (b)(1)(ii) provides that, for States that do not meet those
criteria, the cooperative agreement will provide that the Cooperating
State Agency is eligible for payment of 25 percent of the costs of
surveillance and monitoring and 25 percent of the costs of vaccine
administration, as determined in the cooperative agreement.
The reasons why we believe 100 percent payment for eligible costs
is appropriate for participating States are discussed in detail earlier
in this document under the heading ``Differences Between This Approach
and the Approach Used in Virginia and Texas in 2002.'' We are providing
25 percent of eligible costs for nonparticipating States in order to
provide an additional incentive for States to participate while
continuing to provide some relief for costs associated with outbreaks
of H5/H7 LPAI.
Paragraph (b)(2) provides that transfer of vaccine must be
accomplished through a cooperative agreement between the Cooperating
State Agency and APHIS.
Paragraph (c) of this section states that States will be
responsible for making the determination to request Federal assistance
in the event of an outbreak of H5/H7 LPAI. This provision is also
included in Sec. 146.2, and is discussed in more detail under the
heading ``Administration'' earlier in this document; we have included
it in Sec. 56.2 to further indicate that it is a State decision to
invoke the regulations in part 56.
Payment of Indemnity
Section 56.3 sets out the costs for which indemnity may be paid
under the indemnity program for H5/H7 LPAI and the percentage of those
costs that are eligible for indemnity.
Paragraph (a) of this section sets out 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 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.
Paragraph (b) of Sec. 56.3 sets out the percentage of these costs
for which the Administrator is authorized to pay indemnity for
participants and nonparticipants in the voluntary AI control programs
in 9 CFR parts 145 and 146. Under this paragraph, the Administrator is
authorized to pay indemnity for 100 percent of eligible costs related
to infected or exposed poultry, unless the poultry meet any of the
conditions listed below. If the poultry meet any of those conditions,
the Administrator is authorized to pay indemnity for only 25 percent of
eligible costs:
The poultry are breeding table egg-layers, meat-type
chickens, or meat-type turkeys from a flock that participates in at
least one disease control program in the Plan for breeding poultry
flocks in 9 CFR part 145 but does not participate in the Plan AI
control program for table egg-layer, meat-type chicken, or meat-type
turkey breeding flocks;
The poultry are commercial table-egg layers from a
premises that has 75,000 or more birds and that does not participate in
the U.S. H5/H7 Avian Influenza Monitored program for commercial table-
egg layer flocks described earlier in this document;
The poultry are commercial meat-type chickens that are
associated with a slaughter plant that slaughters 200,000 or more meat-
type chickens per operating week and that does not participate in the
U.S. H5/H7 Avian Influenza Monitored program for commercial meat-type
chicken slaughter plants described earlier in this document;
The poultry are commercial meat-type turkeys that are
associated with a slaughter plant that slaughters 2 million or more
meat-type turkeys in a 12-month period and that does not participate in
the U.S. H5/H7 Avian Influenza Monitored program for commercial meat-
type turkey slaughter plants described earlier in this document; or
The infected or exposed poultry are associated with a
flock or slaughter plant that participates in the relevant Plan AI
control program, but the State
[[Page 56318]]
in which they participate does not participate in the NPIP diagnostic
surveillance program for H5/H7 LPAI, as described in Sec. 146.14, or
does not have an initial State response and containment plan for H5/H7
LPAI that is approved by APHIS, as described in Sec. 56.10. However,
if the poultry participate in the Plan with another State that does
participate in the National Poultry Improvement Plan diagnostic
surveillance program for H5/H7 LPAI, as described in Sec. 146.14, and
has an initial State response and containment plan for H5/H7 LPAI that
is approved by APHIS, they would be eligible for 100 percent indemnity.
The reasons why we believe 100 percent indemnity for eligible costs
is appropriate for most poultry are discussed in detail earlier in this
document under the heading ``Differences Between This Approach and the
Approach Used in Virginia and Texas in 2002.'' We are providing the
authority to pay 25 percent indemnity for eligible costs for
nonparticipants in order to provide an additional incentive for owners
of commercial enterprises and owners of breeding poultry that
participate in the Plan to participate in the AI surveillance programs,
while continuing to provide some relief for costs associated with
outbreaks of H5/H7 LPAI.
Under paragraph (b) of Sec. 56.3, table-egg layer flocks and meat-
type chicken and meat-type turkey slaughter plants that are smaller
than the size standards in part 146 are always eligible to receive
indemnity for 100 percent of the costs listed in paragraph (a). We are
not providing owners of those smaller flocks and slaughter plants with
an incentive to participate in an active surveillance program because
these programs described in part 146 are designed for large commercial
flocks and slaughter plants. (Owners of smaller flocks and slaughter
plants may participate in the Plan without participating in the active
surveillance programs and thus receive the Plan seal of approval to use
as a marketing tool.)
As discussed earlier in this document, many States conduct AI
surveillance programs, some of which are designed for table-egg layer
flocks and meat-type chicken and meat-type turkey slaughter plants that
are smaller than the size standards in paragraph (b), as well as for
meat-type poultry that do not have an association with a slaughter
plant and for other types of poultry. These programs may have testing
requirements that are equivalent to those in the active surveillance
programs in part 146 if those testing requirements are sufficient to
detect a 25 percent or greater prevalence of H5/H7 LPAI at a confidence
interval of 95 percent or greater.
Although we have provided in this interim rule that all poultry
associated with table-egg layer flocks and meat-type chicken and meat-
type turkey slaughter plants that are smaller than these size standards
and from flocks of other types of poultry will be eligible to receive
100 percent indemnity, it may 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 could
encourage owners of smaller flocks to participate in the State AI
testing programs designed for those flocks. For example, we could add
provisions to the regulations specifying that if infected or exposed
poultry are eligible to participate in an active surveillance program
whose testing requirements have been recognized by APHIS as equivalent
to the testing requirements for the H5/H7 LPAI surveillance programs in
part 146, but do not participate in that program, their owner would be
eligible to receive indemnity for less than 100 percent of costs
related to an H5/H7 LPAI outbreak. We invite 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.
Paragraph (c) of this section indicates that if the recipient of
indemnity for any of the activities listed in paragraph (a) also
receives payment for any of those activities from a State or from other
sources, the indemnity provided under 9 CFR part 56 will be reduced by
the total amount of payment received from the State or other sources.
This provision ensures that recipients of indemnity will not receive
payment twice for the same loss.
Determination of Indemnity Amounts
Section 56.4 sets out requirements related to the determination of
the amount of indemnity that may be paid with regard to each category
of cost for which indemnity may be paid under Sec. 56.3. These include
provisions for the appraisal and destruction of poultry eligible for
indemnity; provisions for the appraisal of eggs destroyed during
testing for H5/H7 LPAI during an outbreak of H5/H7 LPAI; and provisions
for providing evidence of actual costs for cleaning and disinfection
and undertaking cleaning and disinfection under a compliance agreement,
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, indemnity for the materials to
be destroyed and disposed.
Paragraph (a)(1) of this section states that indemnity for poultry
infected with or exposed to H5/H7 LPAI and subject to destruction will
be based on the fair market value of the poultry, as determined by an
appraisal. Poultry infected with or exposed to H5/H7 LPAI that are
removed by APHIS or a Cooperating State Agency from a flock for testing
will be appraised by an APHIS official appraiser and a State official
appraiser jointly, or, if APHIS and State authorities agree, by either
an APHIS official appraiser or a State official appraiser alone. The
use of multiple appraisers will provide maximum assurance that an
appropriate fair market value will be determined for the poultry
subject to destruction, while the provision that allows appraisers to
act singly upon agreement of APHIS and State authorities will ensure
that an adequate number of appraisers are available for fast-moving
outbreaks.
Appraisals for commercial poultry differ somewhat from appraisals
for other livestock. In a typical livestock appraisal, an animal's
value is determined by finding sale prices for comparable animals. This
method is unworkable for commercial poultry, because the poultry are
not sold at market but rather are owned by the same entity throughout
the production process; the first price data available for poultry are
often wholesale prices for carcasses or eggs. Therefore, APHIS
economists have developed means to determine the fair market value of
commercial poultry at various stages of production by examining the
costs involved in the production of the poultry and the wholesale
prices of the resulting carcasses or eggs. These means have been used
to determine compensation in poultry disease eradication efforts such
as the effort to eradicate H5/H7 LPAI in Virginia and Texas in 2002.\8\
If we use these means
[[Page 56319]]
to value commercial poultry in an H5/H7 LPAI outbreak, we would also
require State official appraisers to use them whenever applicable.
---------------------------------------------------------------------------
\8\ A more detailed description of the process we would use to
appraise commercial poultry can be found in the economic analysis
prepared for this interim rule. For information on how to obtain
this analysis, see the section headed ``Executive Order 12866 and
Regulatory Flexibility Act'' later in this document.
---------------------------------------------------------------------------
APHIS would appraise poultry outside of this framework if
circumstances warrant. For example, breeding poultry with exceptional
genetics might need to be appraised independently in order to arrive at
their fair market value. For poultry sold in the live bird marketing
system, market price data might be available to provide an appraisal.
Paragraph (a)(1) further requires that appraisals of poultry must
be reported on forms furnished by APHIS and signed by the appraisers
and that the appraisals must be signed by the owners of the poultry to
indicate agreement with the appraisal amount. Appraisals of poultry
must be signed by the owners of the poultry prior to the destruction of
the poultry, unless the owners, APHIS, and the Cooperating State Agency
agree that the poultry may be destroyed immediately. Reports of
appraisals must show the number of birds and the value per head.
Paragraph (a)(2) of this section states that indemnity for disposal
of poultry infected with or exposed to H5/H7 LPAI will be based on
receipts or other documentation maintained by the claimant verifying
expenses for disposal activities authorized by part 56. Under this
paragraph, any disposal of poultry infected with or exposed to H5/H7
LPAI for which compensation is requested must be performed under a
compliance agreement between the claimant, the Cooperating State
Agency, and APHIS. APHIS will review claims for compensation for
disposal 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. The compliance agreement and
the APHIS review will help to ensure that APHIS does not pay disposal
costs in excess of what is necessary; the fact that the disposal
requirements are based on the guidelines in Sec. 56.5 and the initial
State response and containment plan means that they will ensure that
cleaning and disinfection is conducted properly while taking into
account local conditions. If disposal is performed by the Cooperating
State Agency, paragraph (a)(2) provides that APHIS will indemnify the
Cooperating State Agency for disposal under a cooperative agreement.
Paragraph (a)(3) requires 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, as described in Sec.
56.10. As discussed earlier in this document, the initial State
response and containment plan is a requirement for any State that
wishes to participate in a cooperative agreement with APHIS and be
eligible to receive 100 percent of its costs and ensure that poultry
owners in that State are eligible to receive 100 percent
indemnification.
Paragraph (b) of this section states that indemnity for eggs
destroyed during an outbreak for testing for H5/H7 LPAI will be based
on the fair market value of the eggs, as determined by an appraisal.
Eggs destroyed for testing for H5/H7 LPAI will be appraised by an APHIS
official appraiser and a State official appraiser jointly, or, if APHIS
and State authorities agree, by either an APHIS official appraiser or a
State official appraiser alone. Appraisals of eggs must be reported on
forms furnished by APHIS and signed by the appraisers and must be
signed by the owners of the eggs to indicate agreement with the
appraisal amount. Appraisals of eggs must be signed by the owners of
the eggs prior to the destruction of the poultry, unless the owners,
APHIS, and the Cooperating State Agency agree that the eggs may be
destroyed immediately. Reports of appraisals must show the number of
eggs and the value per egg. It is not necessary to include disposal
requirements for eggs destroyed during testing because testing will in
all cases be conducted in sanitary conditions.
Paragraph (c)(1) of this section states that indemnity for cleaning
and disinfection of premises, conveyances, and materials that came into
contact with poultry that are infected with or exposed to H5/H7 LPAI
will be based on receipts or other documentation maintained by the
claimant verifying expenditures for cleaning and disinfection
activities authorized by part 56. 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. 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.
The compliance agreement and the APHIS review will help to ensure that
APHIS does not pay cleaning and disinfection costs in excess of what is
necessary; the fact that the cleaning and disinfection requirements are
based on the provisions of Sec. 56.5 and the initial State response
and containment plan means that they will ensure that cleaning and
disinfection is conducted properly while taking into account local
conditions.
Paragraph (c)(2) of this section states that 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, indemnity for the destruction of the
materials will be based on the fair market value of those materials, as
determined by an appraisal. Materials will be appraised by an APHIS
official appraiser and a State official appraiser jointly, or, if APHIS
and State authorities agree, by either an APHIS official appraiser or a
State official appraiser alone. Indemnity for disposal of the materials
will be based on receipts or other documentation maintained by the
claimant verifying expenditures for disposal activities authorized by
part 56. Any disposal of materials for which indemnity is requested
must be performed under a compliance agreement between the claimant,
the Cooperating State Agency, and APHIS. APHIS will review claims for
compensation for disposal 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.
Destruction and Disposal of Poultry and Cleaning and Disinfection of
Premises, Conveyances, and Materials
Section 56.5 sets out requirements for the destruction and disposal
of poultry, the cleaning and disinfection of premises, conveyances, and
materials, and the destruction and disposal of materials.
Paragraph (a) of Sec. 56.5 states that poultry that are infected
with or exposed to H5/H7 LPAI may be required to be destroyed at the
discretion of the Cooperating State Agency and APHIS and in accordance
with the initial State response and containment plan. The Cooperating
State Agency and APHIS will select a method to use for the destruction
of such poultry based on the following factors:
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
[[Page 56320]]
The speed with which destruction must be conducted.
This will ensure that the Cooperating State Agency and APHIS take
into consideration all relevant issues when selecting an appropriate
method for destruction of poultry.
Paragraph (b) of Sec. 56.5 states that carcasses of poultry that
have died from H5/H7 LPAI infection or poultry that have been humanely
slaughtered to fulfill depopulation requirements must be disposed of
promptly and efficiently in accordance with the initial State response
and containment plan to prevent the spread of H5/H7 LPAI infection.
Disposal methods will be selected by the Cooperating State Agency and
APHIS and may include one or more of the following: Burial,
incineration, composting, or rendering. Paragraph (b) additionally
states that, regardless of the disposal method used, strict biosecurity
procedures must be implemented and enforced for all personnel and
vehicular movement into and out of the area in accordance with the
initial State response and containment plan to prevent dissemination of
the H5/H7 LPAI virus.
Paragraph (c) of Sec. 56.5 addresses controlled marketing. Under
Sec. 56.5(c), at the discretion of the Cooperating State Agency and
APHIS, poultry that are infected with or exposed to H5/H7 LPAI may be
allowed to move for controlled marketing in accordance with the initial
State response and containment plan and 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 in Sec. 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. Although poultry are likely to be free of the virus 21 days
after the acute phase of the infection has been concluded, they are not
certain to be free of it; the additional test helps reduce the risk
that controlled marketing could spread H5/H7 LPAI.
This paragraph allows controlled marketing for both flocks that
have been infected with and flocks that have been exposed to H5/H7
LPAI. As noted previously in this document, LPAI infection in poultry
is typically not fatal; if a flock is infected with LPAI, the infection
will eventually cease, and the flock will then test negative for LPAI.
In addition, LPAI virus is not found in poultry products, meaning that
products from an infected flock can be safely marketed. If a State
wishes to allow controlled marketing of infected flocks, the conditions
specified in that document under which controlled marketing would be
allowed must be approved by APHIS; in addition, any controlled
marketing must take place under the conditions described above, which
are consistent with the OIE guidelines for NAI that were discussed
earlier in this document. Therefore, we believe that controlled
marketing of an infected flock and its products under the conditions
described above and in accordance with the initial State response and
containment plan would not pose a risk of spreading H5/H7 LPAI to
uninfected poultry.
APHIS will not pay claims for indemnity for infected or exposed
poultry that are allowed to move for controlled marketing; the
regulations in part 56 only authorize payment for poultry infected with
or exposed to H5/H7 LPAI that are destroyed and disposed according to
the regulations in part 56, which means that poultry moved for
slaughter and sale are ineligible for indemnity.
Paragraph (d) of Sec. 56.5 sets out guidelines for performing
cleaning and disinfection of premises, conveyances, and materials.
Premises, conveyances, and materials that came into contact with
poultry infected with or exposed to H5/H7 LPAI must be cleaned and
disinfected, except that materials for which the cost of cleaning and
disinfection would exceed the value of the materials or for which
cleaning and disinfection would be impracticable for any reason may be
destroyed and disposed. All cleaning and disinfection of premises,
conveyances, and materials must be performed in accordance with the
initial State response and containment plan. The guidelines in
paragraph Sec. 56.5(d) will help States develop cleaning and
disinfection plans. The guidelines address preparation for cleaning and
disinfection, conducting the cleaning and disinfection, and activities
to be performed after cleaning and disinfection. Within the cleaning
and disinfection guidelines, four areas are specifically addressed:
Disposal of manure, debris, and feed;
Cleaning of premises and materials;
Disinfection of premises and materials; and
Cleaning and disinfection of conveyances.
The specific, detailed provisions of these guidelines can be found
in the rule portion of this document. Paragraph (d) also indicates
that, in the case of materials for which the cost of cleaning and
disinfection would exceed the value of the materials or for which
cleaning and disinfection would be impracticable for any reason, the
destruction and disposal of the materials must be conducted in
accordance with the initial State response and containment plan
described in Sec. 56.10.
Presentation of Claims for Indemnity
Section 56.6 addresses claims for the following costs, which will
be paid by APHIS should they be approved:
The value of poultry to be destroyed due to infection with
H5/H7 LPAI;
The value of eggs to be destroyed during testing for H5/H7
LPAI; and
The cost of cleaning and disinfection of premises,
conveyances, and materials that came into contact with poultry 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 cost of destruction and disposal for the materials.
The section requires that claims for these costs must be documented
on a form furnished by APHIS and presented to an APHIS employee or the
State representative authorized to accept the claims.
Mortgage Against Poultry or Eggs
Section 56.7 requires that when poultry or eggs have been destroyed
under part 56, any claim for indemnity be presented on forms furnished
by APHIS. The owner of the poultry or eggs must certify on the forms
that the poultry or eggs covered are, or are not, subject to any
mortgage as defined in Sec. 56.1. If the owner states there is a
mortgage, the owner and each person holding a mortgage on the poultry
or eggs must sign, consenting to the payment of indemnity to the person
specified on the form.
Conditions for Payment
As mentioned earlier in this document under the heading
``Differences Between This Approach and the Approach Used in Virginia
and Texas in 2002,'' this indemnity program contains provisions
specifically ensuring that contract growers, or anyone else providing
services related to the growing and care of the birds, receive payment
for their services when indemnity is provided for birds destroyed under
their care. Just as in the Virginia and Texas outbreaks, we
[[Page 56321]]
believe it is important to ensure that all participants in the poultry
industry with a stake in the continued health of the U.S. poultry stock
are compensated for costs associated with the eradication of outbreaks
of H5/H7 LPAI.
Therefore, Sec. 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
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 this section, 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. For example,
suppose a meat-type chicken flock belonging to an owner who
participated in the Plan is destroyed and disposed of under this part,
and the flock was appraised at $1,000. The flock was being grown by a
contractor with a $500 contract; half of the contract's duration had
elapsed. The contractor would be eligible to receive $250 in indemnity,
and the owner would be eligible to receive the difference, $750.
For losses resulting from the H5/H7 LPAI outbreak in Virginia and
Texas, the Administrator was authorized to pay 100 percent of the costs
contract growers incurred and up to 75 percent of the total costs
poultry owners incurred related to destruction and disposal of poultry
affected by H5/H7 LPAI. This section does not structure indemnity
payments in this manner. Under paragraph (b) of Sec. 56.8, the
Administrator is authorized to pay contract growers and other parties
with contractual claims 100 percent of eligible costs related to the
destruction and disposal of poultry infected with or exposed to H5/H7
LPAI, and 100 percent of eligible costs related to the destruction of
eggs during testing of commercial poultry for H5/H7 LPAI during
outbreaks, unless the producer of the poultry or eggs is a commercial
poultry producer that does not participate in the LPAI control program
or a breeding poultry producer that participates in the Plan but not in
the AI control program. In the latter case, the Administrator is
authorized to pay contract growers and other parties with contractual
claims 25 percent of eligible costs.
Paragraph (c) of this section explicitly states that if indemnity
is paid to a contractor under Sec. 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.
Paragraph (d) of this section provides that in the event that
determination of indemnity to a party with which the owner of destroyed
poultry or eggs has entered into a contract for the growing or care of
the poultry or eggs as described in paragraph (a) is determined to be
impractical or inappropriate, APHIS may use any other method that the
Administrator deems appropriate to make that determination. This
provision provides APHIS with flexibility in the event that the formula
described previously does not result in an appropriate distribution of
indemnity.
Claims Not Allowed
Section 56.9 states that the Department will not allow the
following claims:
Claims arising out of the destruction of poultry unless
the poultry have been appraised as prescribed in Sec. 56.4 and the
owners have signed the appraisal form indicating agreement with the
appraisal amount as required by Sec. 56.4(a)(1).
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. Persons who do not maintain
their poultry and premises in accordance with this written agreement
will not be eligible to receive indemnity under this part.
Claims arising out of the destruction of poultry unless
the poultry have been moved or handled by the owner in accordance with
an agreement for the control and eradication of H5/H7 LPAI and in
accordance with part 56, for any progeny of any poultry unless the
poultry have been moved or handled by the owner in accordance with an
agreement for the control and eradication of H5/H7 LPAI and in
accordance with part 56, or for any poultry that become or have become
infected with or exposed to H5/H7 LPAI because of actions not in
accordance with an agreement for the control and eradication of H5/H7
LPAI or a violation of part 56.
These provisions are consistent with the relevant provisions of the
Animal Health Protection Act, which are found at 7 U.S.C. 8306(d)(3).
Initial State Response and Containment Plan
Section 56.10 states that, in order for poultry owners within a
State to be eligible for 100 percent indemnity under paragraph Sec.
56.3(b)(1), the State in which the poultry owners participate in the
NPIP must have in place an initial State response and containment plan
that has been approved by APHIS. The plan must be developed by the
Official State Agency and administered by the Cooperating State Agency
of the relevant State. Section 56.10 also sets out the elements that
this plan must include:
Provisions for a standing emergency disease management
committee, regular meetings, and exercises, including coordination with
any tribal governments that may be affected;
A minimum biosecurity plan followed by all poultry
producers;
Provisions for adequate diagnostic resources;
Detailed, specific procedures for initial handling and
investigation of suspected cases of H5/H7 LPAI;
Detailed, specific procedures for reporting test results
to APHIS. These procedures must be developed after appropriate
consultation with poultry producers in the State and must provide for
the reporting only of confirmed cases of H5/H7 LPAI in accordance with
9 CFR 146.13;
Detailed, strict quarantine measures for presumptive and
confirmed index cases;
Provisions for developing flock plans for infected and
exposed flocks;
Detailed plans for disposal of infected flocks, including
preexisting agreements with regulatory agencies and detailed plans for
carcass disposal, disposal sites, and resources for conducting
disposal, and detailed plans for disposal of materials that come into
contact with poultry infected with or exposed to H5/H7 LPAI;
[[Page 56322]]
Detailed plans for cleaning and disinfection of premises,
repopulation, and monitoring after repopulation;
Provisions for appropriate control/monitoring zones,
contact surveys, and movement restrictions;
Provisions for monitoring activities in control zones;
If vaccination is considered as an option, a written plan
for use in place with proper controls and provisions for APHIS approval
of any use of vaccine;
Plans for H5/H7 LPAI-negative flocks that provide for
quarantine, testing, and controlled marketing; and
Public awareness and education programs regarding avian
influenza.
We believe that any State with a plan that includes all these
elements is fully capable of determining whether H5/H7 LPAI is present
in flocks that participate in the Plan within that State and taking
action to respond to any outbreaks of H5/H7 LPAI that may occur. A
model initial State response and containment plan is available by
contacting the person listed under FOR FURTHER INFORMATION CONTACT or
on the Regulations.gov Web site (see ADDRESSES above for instructions
for accessing Regulations.gov). APHIS plans to distribute the model
initial State response and containment plan as a guide to help States
develop initial State response and containment plans for approval by
APHIS; the model plan sets out what would typically be considered to be
provisions that would satisfy the requirements for an initial State
response and containment plan in this interim rule. We invite public
comment on the model initial State response and containment plan.
Section 56.10 also provides that if a State has U.S. Avian
Influenza Monitored status under Sec. 146.24(a) or 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. If a
State completes the actions required by the initial State response and
containment plan, 90 days will provide adequate time to complete the
post-outbreak surveillance necessary to establish that the State is
free of H5/H7 LPAI. As discussed earlier in this document in the
context of the special provisions for table-egg layers and meat-type
turkeys, APHIS reserves the right to remove U.S. Avian Influenza
Monitored status from a State entirely if there is a discontinuation of
any of the conditions required to attain that status, if repeated
outbreaks of the H5/H7 subtypes of avian influenza occur in table-egg
layer or meat-type turkey flocks, or if an infection spreads from the
originating premises in a State.
Miscellaneous Changes
The new part 146 is titled ``National Poultry Improvement Plan for
Commercial Poultry.'' The title of part 145 has been ``National Poultry
Improvement Plan.'' Prior to the publication of this interim rule, the
only poultry included in the Plan (and, thus, in part 145) had been
breeding poultry. To ensure clarity, we are amending the title of part
145 to read ``National Poultry Improvement Plan for Breeding Poultry.''
Section 147.45 of the auxiliary provisions of the NPIP provides
that each cooperating State is entitled to one official delegate at
Plan conferences for each of the programs prescribed in subparts B, C,
D, E, and F of 9 CFR part 145 in which it has one or more participants
at the time of the Plan conference. We are amending this section to
accommodate the addition of the new programs in 9 CFR part 146 by
stating that each cooperating State is also entitled to one official
delegate for each of the programs prescribed in subparts B, C, and D of
9 CFR part 146. We are also amending Sec. 147.46(a) by providing for
the establishment of committees to give preliminary consideration to
the proposed changes falling in their respective fields for egg-type
commercial chickens, meat-type commercial chickens, and meat-type
commercial turkeys.
Immediate Action
We believe that it is necessary to establish a voluntary LPAI
control program and an LPAI indemnity program in an interim rule in
order to proactively address the increasing threat of mutation to HPAI
posed by outbreaks of H5/H7 LPAI, including the H7N2 LPAI virus present
in New York and New Jersey, and thus mitigate the potential poultry and
human health threat of an H5/H7 HPAI virus. Under these circumstances,
the Administrator has determined that prior notice and opportunity for
public comment are contrary to the public interest and that there is
good cause under 5 U.S.C. 553 for making this action effective less
than 30 days after publication in the Federal Register.
We will consider comments we receive during the comment period for
this interim rule (see DATES above). After the comment period closes,
we will publish another document in the Federal Register. The document
will include a discussion of any comments we receive and any amendments
we are making to the rule.
Executive Order 12866 and Regulatory Flexibility Act
This rule has been reviewed under Executive Order 12866. The 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.
We have prepared an economic analysis for this rule. The economic
analysis provides a cost-benefit analysis, as required by Executive
Order 12866, and an initial regulatory flexibility analysis that
examines the potential economic effects of this interim rule on small
entities, as required by the Regulatory Flexibility Act. The economic
analysis is summarized below. Copies of the full analysis are available
by contacting the person listed under FOR FURTHER INFORMATION CONTACT
or on the Regulations.gov Web site (see ADDRESSES above for
instructions for accessing Regulations.gov).
Under the interim rule, the U.S. Department of Agriculture (USDA)
will compensate both owners and growers for losses arising from
depopulation of birds affected with H5/H7 LPAI.
In general, benefits of depopulating birds affected with H5/H7 LPAI
come from containing the spread of the disease. Benefits of containing
disease spread fall into three general categories: (1) Avoided owner
and grower losses from disease morbidity and mortality; (2) avoided
consumer price increases resulting from decreased supplies; and (3)
avoided trade bans (State, regional, or national) that result when
trading partners close markets during or after a disease outbreak.
The groups who enjoy the primary benefit of a disease eradication
campaign are consumers and those owners/growers whose flocks have
remained healthy. The group who bears the primary burden of the
eradication effort is the owners and/or growers whose flocks are
depopulated. 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 are
derived from avoiding costs incurred when an outbreak occurs. Evidence
of types of benefits gained from control of avian influenza is found in
the USDA-Economic Research Service study of a 1983-84 outbreak
(summarized in the full economic analysis). Also, the 2002 outbreak in
Virginia provides evidence of the costs incurred due to an avian
influenza incident. This evidence shows
[[Page 56323]]
that the costs of an avian influenza outbreak can be substantial.
To the extent that the interim 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
avoiding LPAI outbreaks and losses should an outbreak occur, exceed the
cost to producers and States of participating in disease prevention
efforts. Under the rule, producers would be required to keep flocks and
facilities clean, slaughter plants would be required to conduct
sampling, and States would be required to conduct annual inspections
and develop response and containment plans. As the Federal part of the
control program, APHIS would provide full indemnity for specific costs
to participating producers and States should an outbreak occur. Related
to, but separate from, this LPAI rule, APHIS received about $14 million
in fiscal year 2006 appropriations for LPAI efforts, including almost
$2 million in NPIP cooperative agreements to 24 States for ongoing
surveillance.
Executive Order 12372
This program/activity is listed in the Catalog of Federal Domestic
Assistance under No. 10.025 and is subject to Executive Order 12372,
which requires intergovernmental consultation with State and local
officials. (See 7 CFR part 3015, subpart V.)
Executive Order 12988
This rule has been reviewed under Executive Order 12988, Civil
Justice Reform. This rule: (1) Preempts all State and local laws and
regulations that are in conflict with this rule; (2) has no retroactive
effect; and (3) does not require administrative proceedings before
parties may file suit in court challenging this rule.
Paperwork Reduction Act
In accordance with section 3507(j) of the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.), the information collection and
recordkeeping requirements included in this interim rule have been
submitted for emergency approval to the Office of Management and
Budget.
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 proposed rule, please contact Mrs. Celeste
Sickles, APHIS' Information Collection Coordinator, at (301) 734-7477.
List of Subjects
9 CFR Part 53
Animal diseases, Indemnity payments, Livestock, Poultry and poultry
products.
9 CFR Part 56
Animal diseases, Indemnity payments, Low pathogenic avian
influenza, Poultry.
9 CFR Parts 145, 146, and 147
Animal diseases, Poultry and poultry products, Reporting and
recordkeeping requirements.
0
Accordingly, we are amending 9 CFR chapter I as follows:
PART 53--FOOT-AND-MOUTH DISEASE, PLEUROPNEUMONIA, RINDERPEST, AND
CERTAIN OTHER COMMUNICABLE DISEASES OF LIVESTOCK OR POULTRY
0
1. The authority citation for 9 CFR part 53 continues to read as
follows:
Authority: 7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4.
Sec. 53.4 [Amended]
0
2. Section 53.4 is amended as follows:
0
a. In paragraph (a), by removing the third sentence.
0
b. In paragraph (a), in the fourth sentence, by removing the words ``or
poultry.''
0
c. By removing and reserving paragraph (b).
Sec. 53.8 [Amended]
0
3. Section 53.8 is amended as follows:
0
a. In paragraph (a) introductory text, by removing the words ``Except
for claims made under Sec. 53.11, claims'' and adding the word
``Claims'' in their place.
0
b. By removing and reserving paragraph (b) and removing paragraph (c).
Sec. 53.11 [Removed]
0
4. Section 53.11 is removed.
0
5. A new part 56 is added to read as follows.
PART 56--CONTROL OF H5/H7 LOW PATHOGENIC AVIAN INFLUENZA
Sec.
56.1 Definitions.
56.2 Cooperation with States.
56.3 Payment of indemnity.
56.4 Determination of indemnity amounts.
56.5 Destruction and disposal of poultry and cleaning and
disinfection of premises, conveyances, and materials.
56.6 Presentation of claims for indemnity.
56.7 Mortgage against poultry or eggs.
56.8 Conditions for payment.
56.9 Claims not allowed.
56.10 Initial State response and containment plan.
Authority: 7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4.
Sec. 56.1 Definitions.
Administrator. The Administrator, Animal and Plant Health
Inspection Service, or any other employee of the Animal and Plant
Health Inspection Service delegated to act in the Administrator's
stead.
Animal and Plant Health Inspection Service (APHIS). The Animal and
Plant Health Inspection Service of the U.S. Department of Agriculture.
Breeding flock. A flock that is composed of stock that has been
developed for commercial egg or meat production and is maintained for
the principal purpose of producing chicks for the ultimate production
of eggs or meat for human consumption.
Classification. A designation earned by participation in a Plan
program.
Commercial meat-type flock. All of the meat-type chickens or meat-
type turkeys on one farm. However, at the discretion of the Official
State Agency, 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 may be
considered as a separate flock.
Commercial table-egg layer flock. All table-egg layers of one
classification in one barn or house.
Commercial table-egg layer premises. A farm containing contiguous
flocks of commercial table-egg layers under common ownership.
Cooperating State Agency. Any State authority recognized by the
Department to cooperate in the administration of the provisions of this
part 56. This may include the State animal health authority or the
Official State Agency.
Department. The U.S. Department of Agriculture.
Domesticated. Propagated and maintained under the control of a
person.
Flock plan. 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
[[Page 56324]]
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.
H5/H7 low pathogenic avian influenza (LPAI). An infection of
poultry caused by an influenza A virus of H5 or H7 subtype that has an
intravenous pathogenicity index test in 6-week-old chickens less than
1.2 or any infection with influenza A viruses of H5 or H7 subtype for
which nucleotide sequencing has not demonstrated the presence of
multiple basic amino acids at the cleavage site of the hemagglutinin.
H5/H7 LPAI exposed. At risk of developing H5/H7 LPAI because of
association with birds or poultry infected with H5/H7 LPAI, excrement
from birds or poultry infected with H5/H7 LPAI, or other material
touched by birds or poultry infected with H5/H7 LPAI, or because there
is reason to believe that association has occurred with H5/H7 LPAI or
vectors of H5/H7 LPAI, as determined by the Cooperating State Agency
and confirmed by APHIS.
H5/H7 LPAI virus infection (infected). Poultry will be considered
to be infected with H5/H7 LPAI for the purposes of this part if:
(1) H5/H7 LPAI virus has been isolated and identified as such from
poultry; or
(2) Viral antigen or viral RNA specific to the H5 or H7 subtype of
AI virus has been detected in poultry; or
(3) 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.
Meat-type chicken. A domesticated chicken grown for the primary
purpose of producing meat including but not limited to broilers,
roasters, fryers, and cornish.
Meat-type turkey. A domesticated turkey grown for the primary
purpose of producing meat.
Mortgage. Any mortgage, lien, or other security or beneficial
interest held by any person other than the one claiming indemnity for
the destruction of poultry or eggs due to H5/H7 LPAI.
Official appraiser (APHIS official appraiser, State official
appraiser). A person authorized by APHIS to appraise poultry for the
purposes of this part. A State official appraiser is selected by a
State and authorized by APHIS.
Official State Agency. The State authority recognized by the
Department to cooperate in the administration of the Plan.
Plan. The provisions of the National Poultry Improvement Plan
contained in parts 145, 146, and 147 of this chapter.
Poultry. Domesticated fowl, including chickens, turkeys, ostriches,
emus, rheas, cassowaries, waterfowl, and game birds, except doves and
pigeons, which are bred for the primary purpose of producing eggs or
meat.
Secretary. The Secretary of the United States Department of
Agriculture, or any officer or employee of the Department delegated to
act in the Secretary's stead.
State. Any of the States, the District of Columbia, the
Commonwealth of Puerto Rico, Guam, the Commonwealth of the Northern
Mariana Islands, the Virgin Islands of the United States, or any
territory or possession of the United States.
Table-egg layer. A domesticated chicken grown for the primary
purpose of producing eggs for human consumption.
United States. All of the States.
Sec. 56.2 Cooperation with States.
(a) The Administrator has been delegated the authority to cooperate
with Cooperating State Agencies in the eradication of H5/H7 LPAI. This
cooperation may include, but is not necessarily limited to, the
following activities:
(1) Payment to Cooperating State Agencies for surveillance and
monitoring associated with poultry that have been infected with or
exposed to H5/H7 LPAI;
(2) Transfer of vaccine for H5/H7 LPAI to Cooperating State
Agencies if provided for in the initial State response and containment
plan developed by the Official State Agency and approved by APHIS under
Sec. 56.10; and
(3) Payment for vaccine administration by Cooperating State
Agencies, if provided for in the initial State response and containment
plan developed by the Official State Agency and approved by APHIS under
Sec. 56.10
(b)(1) Any payment made to a State or an Official State Agency for
the activities listed in paragraphs (a)(1) and (a)(3) of this section
must be made through a cooperative agreement between the Cooperating
State Agency and APHIS. The payment for which the Cooperating State
Agency is eligible will be determined in the cooperative agreement.
(i) For any Cooperating State Agency that participates in the
National Poultry Improvement Plan 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, as described in Sec. 56.10 of this part, the
cooperative agreement will provide that the Cooperating State Agency is
eligible for payment of 100 percent of the costs of surveillance and
monitoring and 100 percent of the costs of vaccine administration, as
determined in the cooperative agreement.
(ii) For any Cooperating State Agency that does not meet the
criteria in paragraph (b)(1)(i) of this section, the cooperative
agreement will provide that the Cooperating State Agency is eligible
for payment of 25 percent of the costs of surveillance and monitoring
and 25 percent of the costs of vaccine administration, as determined in
the cooperative agreement.
(2) Transfer of vaccine under paragraph (a)(2) of this section must
be accomplished through a cooperative agreement between the Cooperating
State Agency and APHIS.
(c) States will be responsible for making the determination to
request Federal assistance under this part in the event of an outbreak
of H5/H7 LPAI.
Sec. 56.3 Payment of indemnity.
(a) Activities eligible for indemnity. The Administrator may pay
indemnity for the activities listed in paragraphs (a)(1) through (a)(3)
of this section, as provided in paragraph (b) of this section:
(1) Destruction and disposal of poultry that were infected with or
exposed to H5/H7 LPAI;
(2) Destruction of any eggs destroyed during testing of poultry for
H5/H7 LPAI during an outbreak of H5/H7 LPAI; and
(3) 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.
[[Page 56325]]
(b) Percentage of costs eligible for indemnity. Except for poultry
that are described by the categories in paragraphs (b)(1) through
(b)(7) of this section, the Administrator is authorized to pay 100
percent of the costs, as determined in accordance with Sec. 56.4, of
the activities described in paragraphs (a)(1) through (a)(3) of this
section, regardless of whether the infected or exposed poultry
participate in the Plan. For infected or exposed poultry that are
described by the categories in paragraphs (b)(1) through (b)(7) of this
section, the Administrator is authorized to pay 25 percent of the costs
of the activities described in paragraphs (a)(1) through (a)(3) of this
section:
(1) The poultry are egg-type breeding chickens from a flock that
participates in any Plan program in part 145 of this chapter but that
does not participate in the U.S. Avian Influenza Clean program of the
Plan in Sec. 145.23(h) of this chapter; or
(2) The poultry are meat-type breeding chickens from a flock that
participates in any Plan program in part 145 of this chapter but that
does not participate in the U.S. Avian Influenza Clean program of the
Plan in Sec. 145.33(l) of this chapter; or
(3) The poultry are breeding turkeys from a flock that participates
in any Plan program in part 145 of this chapter but that does not
participate in the U.S. H5/H7 Avian Influenza Clean program of the Plan
in Sec. 145.43(g) of this chapter; or
(4) The poultry are commercial table-egg layers from a premises
that has 75,000 or more birds and that does not participate in the U.S.
H5/H7 Avian Influenza Monitored program of the Plan in Sec. 146.23(a)
of this chapter; or
(5) The poultry are commercial meat-type chickens that are
associated with a slaughter plant that slaughters 200,000 or more meat-
type chickens per operating week and that does not participate in the
U.S. H5/H7 Avian Influenza Monitored program of the Plan in Sec.
146.33(a) of this chapter; or
(6) The poultry are commercial meat-type turkeys that are
associated with a slaughter plant that slaughters 2 million or more
meat-type turkeys in a 12-month period and that does not participate in
the U.S. H5/H7 Avian Influenza Monitored program of the Plan in Sec.
146.43(a) of this chapter; or
(7) The poultry 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 National Poultry Improvement Plan diagnostic
surveillance program for H5/H7 LPAI, as described in Sec. 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, unless such
poultry participate in the Plan with another State that does
participate in the National Poultry Improvement Plan 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.
(c) Other sources of payment. If the recipient of indemnity for any
of the activities listed in paragraphs (a)(1) through (a)(3) of this
section 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.
Sec. 56.4 Determination of indemnity amounts.
(a) Destruction and disposal of poultry. (1) Indemnity for the
destruction of poultry infected with or exposed to H5/H7 LPAI will be
based on the fair market value of the poultry, as determined by an
appraisal. Poultry infected with or exposed to H5/H7 LPAI that are
removed by APHIS or a Cooperating State Agency from a flock will be
appraised by an APHIS official appraiser and a State official appraiser
jointly, or, if APHIS and State authorities agree, by either an APHIS
official appraiser or a State official appraiser alone. For laying
hens, the appraised value should include the hen's projected future egg
production. Appraisals of poultry must be reported on forms furnished
by APHIS and signed by the appraisers and must be signed by the owners
of the poultry to indicate agreement with the appraisal amount.
Appraisals of poultry must be signed by the owners of the poultry prior
to the destruction of the poultry, unless the owners, APHIS, and the
Cooperating State Agency agree that the poultry may be destroyed
immediately. Reports of appraisals must show the number of birds and
the value per head.
(2) Indemnity for disposal of poultry infected with or exposed to
H5/H7 LPAI will be based on receipts or other documentation maintained
by the claimant verifying expenditures for disposal activities
authorized by this part. Any disposal of poultry infected with or
exposed to H5/H7 LPAI for which compensation is requested must be
performed under a compliance agreement between the claimant, the
Cooperating State Agency, and APHIS. APHIS will review claims for
compensation for disposal 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. If disposal is
performed by the Cooperating State Agency, APHIS will indemnify the
Cooperating State Agency for disposal under a cooperative agreement.
(3) The destruction and disposal of the indemnified poultry must be
conducted in accordance with the initial State response and containment
plan for H5/H7 LPAI, as described in Sec. 56.10.
(b) Destruction of eggs. Indemnity for eggs destroyed during an
outbreak for testing for H5/H7 LPAI will be based on the fair market
value of the eggs, as determined by an appraisal. Eggs destroyed for
testing for H5/H7 LPAI will be appraised by an APHIS official appraiser
and a State official appraiser jointly, or, if APHIS and State
authorities agree, by either an APHIS official appraiser or a State
official appraiser alone. Appraisals of eggs must be reported on forms
furnished by APHIS and signed by the appraisers and must be signed by
the owners of the eggs to indicate agreement with the appraisal amount.
Appraisals of eggs must be signed by the owners of the eggs prior to
the destruction of the poultry, unless the owners, APHIS, and the
Cooperating State Agency agree that the eggs may be destroyed
immediately. Reports of appraisals must show the number of eggs and the
value per egg.
(c) Cleaning and disinfection. (1) Indemnity for cleaning and
disinfection of premises, conveyances, and materials that came into
contact with poultry that are infected with or exposed to H5/H7 LPAI
will be based on receipts or other documentation maintained by the
claimant verifying expenditures for cleaning and disinfection
activities authorized by this part. 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. 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.
(2) 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, indemnity for the
destruction of the materials will be based on the fair market value of
those materials, as determined by an appraisal. Materials will be
appraised by an APHIS official appraiser and a State official appraiser
jointly, or, if APHIS
[[Page 56326]]
and State authorities agree, by either an APHIS official appraiser or a
State official appraiser alone. Indemnity for disposal of the materials
will be based on receipts or other documentation maintained by the
claimant verifying expenditures for disposal activities authorized by
this part. Any disposal of materials for which indemnity is requested
must be performed under a compliance agreement between the claimant,
the Cooperating State Agency, and APHIS. APHIS will review claims for
compensation for disposal 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.
Sec. 56.5 Destruction and disposal of poultry and cleaning and
disinfection of premises, conveyances, and materials.
(a) Destruction of poultry. Poultry that are infected with or
exposed to H5/H7 LPAI may be required to be destroyed at the discretion
of the Cooperating State Agency and APHIS and in accordance with the
initial State response and containment plan described in Sec. 56.10.
The Cooperating State Agency and APHIS will select a method to use for
the destruction of such poultry based on the following factors:
(1) The species, size, and number of the poultry to be destroyed;
(2) The environment in which the poultry are maintained;
(3) The risk to human health or safety of the method used;
(4) Whether the method requires specialized equipment or training;
(5) The risk that the method poses of spreading the H5/H7 LPAI
virus;
(6) Any hazard the method could pose to the environment;
(7) The degree of bird control and restraint required to administer
the destruction method; and
(8) The speed with which destruction must be conducted.
(b) Disposal of poultry. Carcasses of poultry that have died from
H5/H7 LPAI infection or poultry that have been humanely slaughtered to
fulfill depopulation requirements must be disposed of promptly and
efficiently in accordance with the initial State response and
containment plan described in Sec. 56.10 to prevent the spread of H5/
H7 LPAI infection. Disposal methods will be selected by the Cooperating
State Agency and APHIS and may include one or more of the following:
Burial, incineration, composting, or rendering. Regardless of the
method used, strict biosecurity procedures must be implemented and
enforced for all personnel and vehicular movement into and out of the
area in accordance with the initial State response and containment plan
to prevent dissemination of the H5/H7 LPAI virus.
(c) Controlled marketing. (1) At the discretion of the Cooperating
State Agency and APHIS, poultry that has been infected with or exposed
to H5/H7 LPAI may be allowed to move for controlled marketing in
accordance with the initial State response and containment plan
described in Sec. 56.10 and in accordance with the following
requirements:
(i) 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 Sec. 56.10; and
(ii) 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.
(2) Poultry moved for controlled marketing will not be eligible for
indemnity under Sec. 56.3.
(d) Cleaning and disinfection of premises, conveyances, and
materials. Premises, conveyances, and materials that came into contact
with poultry infected with or exposed to H5/H7 LPAI must be cleaned and
disinfected; Provided, that materials for which the cost of cleaning
and disinfection would exceed the value of the materials or for which
cleaning and disinfection would be impracticable for any reason may be
destroyed and disposed. Cleaning and disinfection must be performed in
accordance with the initial State response and containment plan
described in Sec. 56.10, which must be approved by APHIS. This
paragraph (d) provides guidelines for the development of a cleaning and
disinfection plan for a premises and for the materials and conveyances
on that premises.
(1) Preparation for cleaning and disinfection. Following the
depopulation or controlled marketing of all poultry infected with or
exposed to H5/H7 LPAI on a premises, the following procedures should be
completed prior to cleaning and disinfection:
(i) 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;
(ii) Apply insecticides and rodenticides immediately after the
removal of the birds, before the house cools;
(iii) Close the house in which the poultry were held, maintaining
just enough ventilation to remove moisture. 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.
(iv) Heat the house to 100 [deg]F for the 72 hours prior to
cleaning and disinfection.
(2) Cleaning and disinfection. All premises, conveyances, and
materials that came into contact with poultry that were infected with
or exposed to H5/H7 LPAI must be cleaned and disinfected. Cleaning and
disinfection must be performed on all buildings that came into contact
with poultry that were infected with or exposed to H5/H7 LPAI within a
premises, including pumphouses and service areas. To accomplish
cleaning and disinfection, the following procedures should be
completed:
(i) Disposal of manure, debris, and feed. Clean up all manure,
debris, and feed. Compost manure, debris, and feed in the house if
possible. If this is not possible, set up a system for hauling manure,
debris, and feed to an approved site for burial, piling, or composting.
Do not clean out the house or move or spread litter until any H5/H7
LPAI virus that may have contaminated the manure and litter is dead, as
determined by the Cooperating State Agency and in accordance with the
initial State response and containment plan described in Sec. 56.10.
If composting is used as a disposal method, manure and litter should be
composted in accordance with State and local regulations. If litter is
piled, the litter pile must be covered and allowed to sit undisturbed
for an amount of time approved by the Cooperating State Agency and
APHIS and in accordance the initial State response and containment plan
described in Sec. 56.10. Drying and heat in situ over time are
effective and may be used in place of composting if weather conditions
or conditions in the building are favorable. After use, equipment used
to clean out manure, debris, and feed must be washed, disinfected, and
inspected at the site to which the manure and litter was transported.
In the case of inclement weather, the equipment may be washed,
disinfected, and inspected at off-site wash stations at the discretion
of the Cooperating State Agency and APHIS.
(ii) Cleaning of premises and materials. Cleaning and washing
should be thorough to ensure that all materials
[[Page 56327]]
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 soap and
water to knock dust down to the floor, using no more water than
necessary. Wash equipment and houses with soap 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 and
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 authorized in Sec.
71.10(a) of this chapter. A power spray unit should be used to spray
the disinfectant on all surfaces, 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.
(vi) Cleaning and disinfection of conveyances. Clean and disinfect
all trucks and vehicles used in transporting affected poultry or
materials before soil dries in place. Both exterior, including the
undercarriage, and interior surfaces, including truck cabs, must be
cleaned. The interior of the truck cabs should be washed with clean
water and sponged with a disinfectant authorized in Sec. 71.10(a) of
this chapter. Manure and litter removed from these vehicles should be
handled in a manner similar to that described in paragraph (d)(2)(i) of
this section.
(3) Activities after cleaning and disinfection. Premises should be
checked for virus before repopulation in accordance with the initial
State response and containment plan described in Sec. 56.10. The
premises may not be restocked with poultry until after the date
specified in the initial State response and containment plan described
in Sec. 56.10.
(4) Destruction and disposal of materials. In the case of materials
for which the cost of cleaning and disinfection would exceed the value
of the materials or for which cleaning and disinfection would be
impracticable for any reason, the destruction and disposal of the
materials must be conducted in accordance with the initial State
response and containment plan described in Sec. 56.10.
Sec. 56.6 Presentation of claims for indemnity.
Claims for the following must be documented on a form furnished by
APHIS and presented to an APHIS employee or the State representative
authorized to accept the claims:
(a) Compensation for the value of poultry to be destroyed due to
infection with or exposure to H5/H7 LPAI;
(b) Compensation for the value of eggs to be destroyed during
testing for H5/H7 LPAI; and
(c) Compensation for the cost of cleaning and disinfection of
premises, conveyances, and materials that came into contact with
poultry 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 cost of destruction and disposal for
the materials.
Sec. 56.7 Mortgage against poultry or eggs.
When poultry or eggs have been destroyed under this part, any claim
for indemnity must be presented on forms furnished by APHIS. The owner
of the poultry or eggs must certify on the forms that the poultry or
eggs covered are, or are not, subject to any mortgage as defined in
this part. If the owner states there is a mortgage, the owner and each
person holding a mortgage on the poultry or eggs must sign the APHIS-
furnished form, consenting to the payment of indemnity to the person
specified on the form.
Sec. 56.8 Conditions for payment.
(a) When poultry or eggs have been destroyed pursuant to this part,
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. The indemnity the Administrator may pay to such
a party or parties shall be determined as follows:
(1) Divide the value of the contract the owner of the poultry or
eggs entered into with another party for the growing and care of the
poultry or eggs in dollars by the duration of the contract as it was
signed prior to the H5/H7 LPAI outbreak in days;
(2) Multiply this figure 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.
(b)(1) If indemnity for the destroyed poultry or eggs is being
provided for 100 percent of eligible costs under Sec. 56.3(b), the
Administrator may pay contractors eligible for compensation under this
section 100 percent of the indemnity determined in paragraph (a) of
this section.
(2) If indemnity for the destroyed poultry or eggs is being
provided for 25 percent of eligible costs under Sec. 56.3(b), the
Administrator may pay contractors eligible for compensation under this
section 25 percent of the indemnity determined in paragraph (a) of this
section.
(c) If indemnity is paid to a contractor under this section, the
owner of the poultry or eggs will be eligible to receive the difference
between the indemnity paid to the growers and the total amount of
indemnity that may be paid for the poultry or eggs.
(d) In the event that determination of indemnity to a party with
which the owner of destroyed poultry or eggs has entered into a
contract for the growing or care of the poultry or eggs using the
method described in paragraph (a) of this section is determined to be
impractical or inappropriate, APHIS may use any other method that the
Administrator deems appropriate to make that determination.
Sec. 56.9 Claims not allowed.
(a) The Department will not allow claims arising out of the
destruction of poultry unless the poultry have been appraised as
prescribed in this part and the owners have signed the appraisal form
indicating agreement with the appraisal amount as required by Sec.
56.4(a)(1).
(b) The Department 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. Persons who do not maintain their poultry and premises in
accordance with this written agreement will not be eligible to receive
indemnity under this part.
(c) The Department will not allow claims arising out of the
destruction of poultry unless the poultry have been moved or handled by
the owner in accordance with an agreement for the control and
eradication of H5/H7 LPAI and in accordance with part 56, for any
progeny of any poultry unless the poultry have been moved or handled by
the owner in accordance with an agreement for the control and
eradication of H5/H7 LPAI and in
[[Page 56328]]
accordance with part 56, or for any poultry that become or have become
infected with or exposed to H5/H7 LPAI because of actions not in
accordance with an agreement for the control and eradication of H5/H7
LPAI or a violation of this part.
Sec. 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 Sec. 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 and administered by the
Cooperating State Agency of the relevant State. This plan must include:
(1) Provisions for a standing emergency disease management
committee, regular meetings, and exercises, including coordination with
any tribal governments that may be affected;
(2) A minimum biosecurity plan followed by all poultry producers;
(3) Provisions for adequate diagnostic resources;
(4) Detailed, specific procedures for initial handling and
investigation of suspected cases of H5/H7 LPAI;
(5) Detailed, specific procedures for reporting test results to
APHIS. These procedures must be developed after appropriate
consultation with poultry producers in the State and must provide for
the reporting only of confirmed cases of H5/H7 LPAI in accordance with
Sec. 146.13 of this chapter;
(6) Detailed, strict quarantine measures for presumptive and
confirmed index cases;
(7) Provisions for developing flock plans for infected and exposed
flocks;
(8) Detailed plans for disposal of infected flocks, including
preexisting agreements with regulatory agencies and detailed plans for
carcass disposal, disposal sites, and resources for conducting
disposal, and detailed plans for disposal of materials that come into
contact with poultry infected with or exposed to H5/H7 LPAI;
(9) Detailed plans for cleaning and disinfection of premises,
repopulation, and monitoring after repopulation;
(10) Provisions for appropriate control/monitoring zones, contact
surveys, and movement restrictions;
(11) Provisions for monitoring activities in control zones;
(12) If vaccination is considered as an option, a written plan for
use in place with proper controls and provisions for APHIS approval of
any use of vaccine;
(13) Plans for H5/H7 LPAI-negative flocks that provide for
quarantine, testing, and controlled marketing; and
(14) Public awareness and education programs regarding avian
influenza.
(b) If a State is designated a U.S. Avian Influenza Monitored
State, Layers under Sec. 146.24(a) of this chapter or a U.S. Avian
Influenza Monitored State, Turkeys under Sec. 146.44(a) of this
chapter, 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.
PART 145--NATIONAL POULTRY IMPROVEMENT PLAN FOR BREEDING POULTRY
0
6. The authority citation for part 145 continues to read as follows:
Authority: 7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4.
0
7. The part heading for part 145 is revised to read as set forth above.
0
8. A new part 146 is added to read as follows.
PART 146--NATIONAL POULTRY IMPROVEMENT PLAN FOR COMMERCIAL POULTRY
Subpart A--General Provisions
Sec.
146.1 Definitions.
146.2 Administration.
146.3 Participation.
146.4 General provisions for all participating flocks and slaughter
plants.
146.5 Specific provisions for participating flocks.
146.6 Specific provisions for participating slaughter plants.
146.7 Terminology and classification; general.
146.8 Terminology and classification; slaughter plants.
146.9 Terminology and classification; flocks, products, and States.
146.10 Supervision.
146.11 Inspections.
146.12 Debarment from participation.
146.13 Testing.
146.14 Diagnostic surveillance program for H5/H7 low pathogenic
avian influenza.
Subpart B--Special Provisions for Commercial Table-Egg Layer Flocks
146.21 Definitions.
146.22 Participation.
146.23 Terminology and classification; flocks and products.
146.24 Terminology and classification; States.
Subpart C--Special Provisions for Meat-Type Chicken Slaughter Plants
146.31 Definitions.
146.32 Participation.
146.33 Terminology and classification; meat-type chicken slaughter
plants.
Subpart D--Special Provisions for Meat-Type Turkey Slaughter Plants
146.41 Definitions.
146.42 Participation.
146.43 Terminology and classification; meat-type turkey slaughter
plants.
146.44 Terminology and classification; States.
Authority: 7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4.
Subpart A--General Provisions
Sec. 146.1 Definitions.
Except where the context otherwise requires, for the purposes of
this subpart the following terms shall be construed, respectively, to
mean:
Administrator. The Administrator, Animal and Plant Health
Inspection Service, or any person authorized to act for the
Administrator.
Affiliated flock. A meat-type flock that is owned by or has an
agreement to participate in the Plan with a slaughter plant and that
participates in the Plan through that slaughter plant.
Animal and Plant Health Inspection Service (APHIS). The Animal and
Plant Health Inspection Service of the U.S. Department of Agriculture.
Authorized Agent. Any person designated under Sec. 146.10(a) to
perform functions under this part.
Authorized laboratory. An authorized laboratory designated by an
Official State Agency, subject to review by the Service, to perform the
diagnostic assays. The Service's review will include, but will not
necessarily be limited to, checking records, laboratory protocol,
check-test proficiency, periodic duplicate samples, and peer review. A
satisfactory review will result in the authorized laboratory being
recognized by the Service as a national approved laboratory qualified
to perform the diagnostic assays provided for in this part.
Classification. A designation earned by participation in a Plan
program.
Commercial meat-type flock. All of the meat-type chickens or meat-
type turkeys on one farm. However, at the discretion of the Official
State Agency, 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 may be
considered as a separate flock.
Commercial table-egg layer flock. All table-egg layers of one
classification in one barn or house.
Commercial table-egg layer premises. A farm containing contiguous
flocks of commercial table-egg layers under common ownership.
[[Page 56329]]
Department. The U.S. Department of Agriculture.
Domesticated. Propagated and maintained under the control of a
person.
Equivalent. Requirements which are equal to the program,
conditions, criteria, or classifications with which compared, as
determined by the Official State Agency and with the concurrence of the
Service.
H5/H7 low pathogenic avian influenza (LPAI). An infection of
poultry caused by an influenza A virus of H5 or H7 subtype that has an
intravenous pathogenicity index test in 6-week-old chickens less than
1.2 or any infection with influenza A viruses of H5 or H7 subtype for
which nucleotide sequencing has not demonstrated the presence of
multiple basic amino acids at the cleavage site of the hemagglutinin.
H5/H7 LPAI virus infection (infected). Poultry will be considered
to be infected with H5/H7 LPAI for the purposes of this part if:
(1) H5/H7 LPAI virus has been isolated and identified as such from
poultry; or
(2) Viral antigen or viral RNA specific to the H5 or H7 subtype of
AI virus has been detected in poultry; or
(3) 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.
Official State Agency. The State authority recognized by the
Department to cooperate in the administration of the Plan.
Person. A natural person, firm, or corporation.
Plan. The provisions of the National Poultry Improvement Plan
contained in this part.
Poultry. Domesticated chickens and turkeys that are bred for the
primary purpose of producing eggs or meat.
Program. Management, sanitation, testing, and monitoring procedures
which, if complied with, will qualify, and maintain qualification for,
designation of a flock, a slaughter plant, or a State by an official
Plan classification and illustrative design, as described in Sec.
146.9 of this part.
Service. The Animal and Plant Health Inspection Service of the U.S.
Department of Agriculture.
State. Any of the States, the District of Columbia, the
Commonwealth of Puerto Rico, Guam, the Commonwealth of the Northern
Mariana Islands, the Virgin Islands of the United States, or any
territory or possession of the United States.
State Inspector. Any person employed or authorized under Sec.
146.10(b) to perform functions under this part.
United States. All of the States.
Sec. 146.2 Administration.
(a) The Department cooperates through a Memorandum of Understanding
with the Official State Agency in the administration of the Plan.
(b) The administrative procedures and decisions of the Official
State Agency are subject to review by the Service. The Official State
Agency shall carry out the administration of the Plan within the State
according to the applicable provisions of the Plan and the Memorandum
of Understanding.
(c)(1) An Official State Agency may accept for participation a
commercial table-egg layer flock or a commercial meat-type flock
(including an affiliated flock) located in another participating State
under a mutual understanding and agreement, in writing, between the two
Official State Agencies regarding conditions of participation and
supervision.
(2) An Official State Agency may accept for participation a
commercial table-egg layer flock or a commercial meat-type flock
(including an affiliated flock) located in a State that does not
participate in the Plan under a mutual understanding and agreement, in
writing, between the owner of the flock and the Official State Agency
regarding conditions of participation and supervision.
(d) The Official State Agency of any State may adopt regulations
applicable to the administration of the Plan in such State further
defining the provisions of the Plan or establishing higher standards,
compatible with the Plan.
(e) An authorized laboratory will follow the laboratory protocols
outlined in part 147 of this chapter when determining the status of a
participating flock with respect to an official Plan classification.
(f) States will be responsible for making the determination to
request Federal assistance under part 56 of this chapter in the event
of an outbreak of H5/H7 LPAI.
Sec. 146.3 Participation.
(a) Any table-egg producer and any meat-type chicken or meat-type
turkey slaughter plant, including its affiliated flocks, may
participate in the Plan when the producer or plant has demonstrated, to
the satisfaction of the Official State Agency, that its facilities,
personnel, and practices are adequate for carrying out the relevant
special provisions of this part and has signed an agreement with the
Official State Agency to comply with the relevant special provisions of
this part.
(b) Each participant shall comply with the Plan throughout the
operating year, or until released by the Official State Agency.
(c) A participating slaughter plant shall participate with all of
the meat-type chicken and/or meat-type turkey flocks that are processed
at the facility, including affiliated flocks. Affiliated flocks must
participate through a written agreement with a participating slaughter
plant that is approved by the Official State Agency.
(d) Participation in the Plan shall entitle the participant to use
the Plan emblem reproduced as follows:
[GRAPHIC] [TIFF OMITTED] TR26SE06.000
(e) Participation in the NPIP by commercial table-egg layers will
cease after September 26, 2008 unless the majority of the commercial
table-egg layer delegates vote to continue the program in accordance
with subpart E of part 147 of this chapter at a National Plan
Conference.
Sec. 146.4 General provisions for all participating flocks and
slaughter plants.
(a) Records that establish the identity of products handled shall
be maintained in a manner satisfactory to the Official State Agency.
(b) Material that is used to advertise products shall be subject to
inspection by the Official State Agency at any time.
(c) Advertising must be in accordance with the Plan, and applicable
rules and regulations of the Official State Agency
[[Page 56330]]
and the Federal Trade Commission. A participant advertising products as
being of any official classification may include in their advertising
reference to associated or franchised slaughter or production
facilities only when such facilities produce products of the same
classification.
(d) Each participant shall be assigned a permanent approval number
by the Service. This number, prefaced by the numerical code of the
State, will be the official approval number of the participant and may
be used on each certificate, invoice, shipping label, or other document
used by the participant in the sale of the participant's products. Each
Official State Agency which requires an approval number for out-of-
State participants to ship into its State shall honor this number.
Sec. 146.5 Specific provisions for all participating flocks.
(a) Participating flocks, and all equipment used in connection with
the flocks, shall be separated from non-participating flocks in a
manner acceptable to the Official State Agency.
(b) Poultry equipment, and poultry houses and the land in the
immediate vicinity thereof, shall be kept in sanitary condition as
recommended in Sec. 147.21(c) of this subchapter.
Sec. 146.6 Specific provisions for participating slaughter plants.
(a) Only meat-type chicken and meat-type turkey slaughter plants
that are under continuous inspection by the Food Safety and Inspection
Service of the Department or under State inspection that the Food
Safety Inspection Service has recognized as equivalent to federal
inspection may participate in the Plan.
(b) To participate in the Plan, meat-type chicken and meat-type
turkey slaughter plants must follow the relevant special provisions in
Sec. Sec. 146.33(a) and 146.43(a), respectively, for sample collection
and flock monitoring, unless they are exempted from the special
provisions under Sec. Sec. 146.32(b) or 146.42(b), respectively.
Sec. 146.7 Terminology and classification; general.
The official classification terms defined in Sec. Sec. 146.8 and
146.9 and the various designs illustrative of the official
classifications reproduced in Sec. 146.9 may be used only by
participants and to describe products that have met all of the specific
requirements of such classifications.
Sec. 146.8 Terminology and classification; slaughter plants.
Participating slaughter plants shall be designated as ``U.S. H5/H7
Avian Influenza Monitored.'' All Official State Agencies shall be
notified by the Service of additions, withdrawals, and changes in
classification.
Sec. 146.9 Terminology and classification; flocks, products, and
States.
Participating flocks (including affiliated flocks), products
produced from them, and States which have met the respective
requirements specified in subparts B, C, or D of this part may be
designated by the following terms or illustrative designs:
(a) U.S. H5/H7 Avian Influenza Monitored. (See Sec. Sec.
146.23(a), 146.33(a), and 146.43(a).)
[GRAPHIC] [TIFF OMITTED] TR26SE06.001
(b) U.S. H5/H7 Avian Influenza Monitored State, Layers. (See Sec.
146.24.)
[GRAPHIC] [TIFF OMITTED] TR26SE06.002
(c) U.S. H5/H7 Avian Influenza Monitored State, Turkeys. (See Sec.
146.44.)
[GRAPHIC] [TIFF OMITTED] TR26SE06.003
Sec. 146.10 Supervision.
(a) The Official State Agency may designate qualified persons as
Authorized Agents to do the sample collecting provided for in Sec.
146.13 of this part.
(b) The Official State Agency shall employ or authorize qualified
persons as State Inspectors to perform the selecting and testing of
participating flocks and to perform the official inspections necessary
to verify compliance with the requirements of the Plan.
(c) Authorities issued to Authorized Agents or State Inspectors
under the provisions of this section shall be subject to cancellation
by the Official State Agency on the grounds of incompetence or failure
to comply with the provisions of the Plan or regulations of the
Official State Agency. Such actions shall not be taken until thorough
investigation has been made by the Official State Agency and the
authorized person has been given notice of the proposed action and the
basis thereof and an opportunity to present his or her views.
Sec. 146.11 Inspections.
(a) Each participating slaughter plant shall 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 this part.
(b) On-site inspections of any participating flocks and premises
will be conducted if a State Inspector determines that a breach of
testing has occurred for the Plan programs for which the flocks are
certified.
(c) The official H5/H7 LPAI testing records of all participating
flocks and slaughter plants shall be examined annually by a State
Inspector. Official H5/H7 LPAI testing records shall be maintained for
3 years.
[[Page 56331]]
Sec. 146.12 Debarment from participation.
Participants in the Plan who, after investigation by the Official
State Agency or its representative, are notified in writing of their
apparent noncompliance with the Plan provisions or regulations of the
Official State Agency shall be afforded a reasonable time, as specified
by the Official State Agency, within which to demonstrate or achieve
compliance. If compliance is not demonstrated or achieved within the
specified time, the Official State Agency may debar the participant
from further participation in the Plan for such period, or
indefinitely, as the Official State Agency may deem appropriate. The
debarred participant shall be afforded notice of the bases for the
debarment and opportunity to present his or her views with respect to
the debarment in accordance with procedures adopted by the Official
State Agency. The Official State Agency shall thereupon decide whether
the debarment order shall continue in effect. Such decision shall be
final unless the debarred participant, within 30 days after the
issuance of the debarment order, requests the Administrator to
determine the eligibility of the debarred participant for participation
in the Plan. In such an event, the Administrator shall determine the
matter de novo in accordance with the rules of practice in 7 CFR part
50, which are hereby made applicable to proceedings before the
Administrator under this section. The definitions in 7 CFR 50.10 and
the following definitions shall apply with respect to terms used in
such rules of practice:
(a) Administrator means the Administrator, Animal and Plant Health
Inspection Service of the U.S. Department of Agriculture, or any
officer or employee to whom authority has heretofore been delegated or
to who authority may hereafter be delegated to act in his or her stead.
(b) [Reserved]
Sec. 146.13 Testing.
(a) Samples. Either egg or blood samples may be used for testing.
Samples must be collected in accordance with the following
requirements:
(1) Egg samples. Egg samples must be collected and prepared in
accordance with the requirements in Sec. 147.8 of this subchapter.
(2) Blood samples. Blood samples obtained in the slaughter plant
should be collected after the kill cut with birds remaining on the kill
line. Hold an open 1.5 mL snap cap micro-centrifuge tube under the neck
of the bird directly after the kill cut and collect drips of blood
until the tube is half full. Keep the blood tubes at room temperature
for the clot to form, which should require a minimum of 4 hours and a
maximum of 12 hours. Refrigerate the tube after the clot has formed.
Put tubes in a container and label it with plant name, date, shift
(A.M. or Day, P.M. or Night), and flock number. After the clot is
formed, the clot should be removed by the Authorized Agent in order to
ensure good-quality sera. Prepare a laboratory submission form and ship
samples with submission forms to the laboratory in a polystyrene foam
cooler with frozen ice packs. Submission forms and the manner of
submission must be approved by the Official State Agency and the
authorized laboratory to ensure that there is sufficient information to
identify the samples and that the samples are received in an acceptable
condition for further tests to be reliably performed. Blood samples
should be shipped routinely to the laboratory. Special arrangements
should be developed for samples held over the weekend to ensure that
the samples can be reliably tested. Blood samples for official tests
shall be drawn by an Authorized Agent or State Inspector.
(b) Avian influenza. The official tests for avian influenza are the
agar gel immunodiffusion (AGID) test and the enzyme-linked
immunosorbent assay (ELISA). These tests may be used on either egg yolk
or blood samples. Standard test procedures for the AGID test for avian
influenza are set forth in Sec. 147.9 of this subchapter.
(1) The AGID test must be conducted on all ELISA-positive samples.
Any samples that are found to be positive by AGID must be further
tested and subtyped by Federal Reference Laboratories using the
hemagglutination inhibition test. Final judgment may be based upon
further sampling or culture results.
(2) The tests must be conducted using antigens or test kits
approved by the Service. Test kits must be licensed by the Service and
approved by the Official State Agency, and tests must be performed in
accordance with the recommendations of the producer or manufacturer.
(3) The official determination of a flock as positive for the H5 or
H7 subtypes of low pathogenic avian influenza may be made only by the
National Veterinary Services Laboratories.
Sec. 146.14 Diagnostic surveillance program for H5/H7 low pathogenic
avian influenza.
(a) The Official State Agency must develop a diagnostic
surveillance program for H5/H7 low pathogenic avian influenza for all
poultry in the State. The exact provisions of the program are at the
discretion of the States. The Service will use the standards in
paragraph (b) of this section in assessing individual State plans for
adequacy, including the specific provisions that the State developed.
The standards should be used by States in developing those plans.
(b) Avian influenza 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 avian influenza 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 low pathogenic avian influenza 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 avian influenza.
Subpart B--Special Provisions for Commercial Table-Egg Layer Flocks
Sec. 146.21 Definitions.
Table-egg layer. A domesticated chicken grown for the primary
purpose of producing eggs for human consumption.
Sec. 146.22 Participation.
(a) Participating commercial table-egg layer flocks shall comply
with the applicable general provisions of subpart A of this part and
the special provisions of subpart B of this part.
(b) Commercial table-egg laying premises with fewer than 75,000
birds are exempt from the special provisions of subpart B of this part.
Sec. 146.23 Terminology and classification; flocks and products.
Participating flocks which have met the respective requirements
specified in this section may be designated by the following terms and
the corresponding designs illustrated in Sec. 146.9 of this part:
(a) U.S. H5/H7 Avian Influenza Monitored. This program is intended
to be the basis from which the table-egg layer industry may conduct a
program
[[Page 56332]]
to monitor for the H5/H7 subtypes of avian influenza. It is intended to
determine the presence of the H5/H7 subtypes of avian influenza in
table-egg layers through routine serological surveillance of each
participating commercial table-egg layer flock. A flock will qualify
for this classification when the Official State Agency determines that
it has met one of the following requirements:
(1) It is a commercial table-egg layer flock in which a minimum of
11 birds or egg samples have been tested negative for antibodies to the
H5/H7 subtypes of avian influenza within 30 days prior to disposal;
(2) It is a commercial table-egg layer flock in which a minimum of
11 birds or egg samples have been tested negative for antibodies to the
H5/H7 subtypes of avian influenza within a 12-month period; or
(3) It is a commercial table-egg layer flock that has an ongoing
active and diagnostic surveillance program for the H5/H7 subtypes of
avian influenza in which the number of birds or egg samples tested is
equivalent to the number required in paragraph (a)(1) or (a)(2) and
that is approved by the Official State Agency and the Service.
(b) [Reserved]
Sec. 146.24 Terminology and classification; States.
(a) U.S. H5/H7 Avian Influenza Monitored State, Layers. (1) A State
will be declared a U.S. H5/H7 Avian Influenza Monitored State, Layers
when it has been determined by the Service that:
(i) All commercial table-egg layer flocks in production within the
State that are not exempt from the special provisions of this subpart B
under Sec. 146.22 are classified as U.S. H5/H7 Avian Influenza
Monitored under Sec. 146.23(a) of this part;
(ii) All egg-type chicken breeding flocks in production within the
State are classified as U.S. Avian Influenza Clean under Sec.
145.23(h) of this subchapter;
(iii) All persons performing poultry disease diagnostic services
within the State are required to report to the Official State Agency,
within 24 hours, the source of all table-egg layer specimens that were
deemed positive on an official test for avian influenza, as designated
in Sec. 146.13(a) of this chapter;
(iv) All table-egg layer specimens that were deemed positive on an
official test for avian influenza, as designated in Sec. 146.13(a) of
this chapter, are sent to an authorized laboratory for subtyping; and
(v) All table-egg layer flocks within the State that are found to
be infected with the H5/H7 subtypes of avian influenza are quarantined,
in accordance with an initial State response and containment plan as
described in part 56 of this chapter and under the supervision of the
Official State Agency.
(2) If there is a discontinuation of any of the conditions
described in paragraph (a)(1) of this section, or if repeated outbreaks
of the H5/H7 subtypes of avian influenza occur in commercial table-egg
layer flocks as described in paragraph (a)(1)(i) of this section, or if
an infection spreads from the originating premises, the Service shall
have grounds to revoke its determination that the State is entitled to
this classification. Such action shall not be taken until a thorough
investigation has been made by the Service and the Official State
Agency has been given an opportunity for a hearing in accordance with
rules of practice adopted by the Administrator.
(b) [Reserved]
Subpart C--Special Provisions for Meat-Type Chicken Slaughter
Plants
Sec. 146.31 Definitions.
Meat-type chicken. A domesticated chicken grown for the primary
purpose of producing meat, including but not limited to broilers,
roasters, fryers, and cornish.
Meat-type chicken slaughter plant. A meat-type chicken slaughter
plant that is federally inspected or under State inspection that the
Food Safety Inspection Service has recognized as equivalent to federal
inspection.
Shift. The working period of a group of employees who are on duty
at the same time.
Sec. 146.32 Participation.
(a) Participating meat-type chicken slaughter plants shall comply
with applicable general provisions of subpart A of this part and the
special provisions of this subpart C.
(b) Meat-type chicken slaughter plants that slaughter fewer than
200,000 meat-type chickens in an operating week are exempt from the
special provisions of this subpart C.
Sec. 146.33 Terminology and classification; meat-type chicken
slaughter plants.
Participating meat-type chicken slaughter plants that have met the
respective requirements specified in this section may be designated by
the following terms and the corresponding designs illustrated in Sec.
146.9 of this part:
(a) U.S. H5/H7 Avian Influenza Monitored. This program is intended
to be the basis from which the meat-type chicken industry may conduct a
program to monitor for the H5/H7 subtypes of avian influenza. It is
intended to determine the presence of the H5/H7 subtypes of avian
influenza in meat-type chickens through routine surveillance of each
participating meat-type chicken slaughter plant. A meat-type chicken
slaughter plant will qualify for this classification when the Official
State Agency determines that it has met one of the following
requirements:
(1) It is a meat-type chicken slaughter plant where a minimum of 11
birds per shift are tested negative for antibodies to the H5/H7
subtypes of avian influenza at slaughter; Provided, that with the
approval of the Official State Agency, fewer than 11 birds per shift
may be tested on any given shift if the total number of birds tested
during the operating month is equivalent to testing 11 birds per shift;
or
(2) It is a meat-type chicken slaughter plant which accepts only
meat-type chickens from flocks where a minimum of 11 birds have been
tested negative for antibodies to the H5/H7 subtypes of avian influenza
no more than 21 days prior to slaughter; or
(3) It is a meat-type chicken slaughter plant that has an ongoing
active and diagnostic surveillance program for the H5/H7 subtypes of
avian influenza in which the number of birds tested is equivalent to
the number required in paragraph (a)(1) or (a)(2) and that is approved
by the Official State Agency and the Service.
(b) [Reserved]
Subpart D--Special Provisions for Meat-Type Turkey Slaughter Plants
Sec. 146.41 Definitions.
Meat-type turkey. A domesticated turkey grown for the primary
purpose of producing meat.
Meat-type turkey slaughter plant. A meat-type turkey slaughter
plant that is federally inspected or under State inspection that the
Food Safety Inspection Service has recognized as equivalent to federal
inspection.
Sec. 146.42 Participation.
(a) Participating meat-type turkey slaughter plants shall comply
with applicable general provisions of subpart A of this part and the
special provisions of this subpart D.
(b) Meat-type turkey slaughter plants that slaughter fewer than 2
million meat-type turkeys in a 12-month period are exempt from the
special provisions of this subpart D.
Sec. 146.43 Terminology and classification; meat-type turkey
slaughter plants.
Participating meat-type turkey slaughter plants which have met the
[[Page 56333]]
respective requirements specified in this section may be designated by
the following terms and the corresponding designs illustrated in Sec.
146.9 of this part:
(a) U.S. H5/H7 Avian Influenza Monitored. This program is intended
to be the basis from which the meat-type turkey industry may conduct a
program to monitor for the H5/H7 subtypes of avian influenza. It is
intended to determine the presence of avian influenza in meat-type
turkeys through routine surveillance of each participating meat-type
turkey slaughter plant. A participating meat-type turkey slaughter
plant will qualify for this classification when the Official State
Agency determines that it has met one of the following requirements:
(1) It is a meat-type turkey slaughter plant at which a sample of a
minimum of 60 birds has tested negative each month for antibodies to
type A avian influenza virus. Positive samples shall be further tested
by an authorized laboratory using the hemagglutination inhibition test
to detect antibodies to the hemagglutinin subtypes H5 and H7. It is
recommended that samples be collected from flocks over 10 weeks of age
with respiratory signs such as coughing, sneezing, snicking, sinusitis,
or rales; depression; or decreases in food or water intake.
(2) It is a meat-type turkey slaughter plant that has an ongoing
active and diagnostic surveillance program for the H5/H7 subtypes of
avian influenza in which the number of birds tested is equivalent to
the number required in paragraph (a)(1) and that is approved by the
Official State Agency and the Service.
(b) [Reserved]
Sec. 146.44 Terminology and classification; States.
(a) U.S. H5/H7 Avian Influenza Monitored State, Turkeys. (1) A
State will be declared a U.S. H5/H7 Avian Influenza Monitored State,
Turkeys when it has been determined by the Service that:
(i) All meat-type turkey slaughter plants within the State that are
not exempt from the special provisions of this subpart D under Sec.
146.42 are classified as U.S. H5/H7 Avian Influenza Monitored under
Sec. 146.43(a) of this part;
(ii) All turkey breeding flocks in production within the State are
classified as U.S. H5/H7 Avian Influenza Clean under Sec. 145.43(g) of
this subchapter;
(iii) All persons performing poultry disease diagnostic services
within the State are required to report to the Official State Agency,
within 24 hours, the source of all meat-type turkey specimens that were
deemed positive on an official test for avian influenza, as designated
in Sec. 146.13(a) of this chapter;
(iv) All meat-type turkey specimens that were deemed positive on an
official test for avian influenza, as designated in Sec. 146.13(a) of
this chapter, are sent to an authorized laboratory for subtyping; and
(v) All meat-type turkey flocks within the State that are found to
be infected with the H5/H7 subtypes of avian influenza are quarantined,
in accordance with an initial State response and containment plan as
described in part 56 of this chapter, and under the supervision of the
Official State Agency.
(2) If there is a discontinuation of any of the conditions
described in paragraph (a)(1) of this section, or if repeated outbreaks
of the H5/H7 subtypes of avian influenza occur in meat-type turkey
flocks as described in paragraph (a)(1)(i) of this section, or if an
infection spreads from the originating premises, the Service shall have
grounds to revoke its determination that the State is entitled to this
classification. Such action shall not be taken until a thorough
investigation has been made by the Service and the Official State
Agency has been given an opportunity for a hearing in accordance with
rules of practice adopted by the Administrator.
PART 147--AUXILIARY PROVISIONS ON NATIONAL POULTRY IMPROVEMENT PLAN
0
9. The authority citation for part 147 continues to read as follows:
Authority: 7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4.
0
10. Section 147.8 is amended as follows:
0
a. In the introductory text, by removing the words ``, and for'' and
adding the word ``; for'' in its place; and by adding the words ``; and
for retaining the classification U.S. H5/H7 Avian Influenza Monitored
under Sec. 146.23(a), Sec. 146.33(a), and Sec. 146.44(a)'' before
the words ``of this chapter''.
0
b. By revising paragraph (b)(7) to read as set forth below.
Sec. 147.8 Procedures for preparing egg yolk samples for diagnostic
tests.
* * * * *
(b) * * *
(7) (i) For egg yolk samples being tested to retain the U.S. M.
Gallisepticum Clean and U.S. M. Synoviae Clean classifications, test
the resultant supernatant for M. gallisepticum and M. synoviae by using
test procedures specified for detecting IgG antibodies set forth for
testing serum in Sec. 147.7 (for these tests the resultant supernatant
would be substituted for serum); except that a single 1:20 dilution
hemagglutination inhibition (HI) test may be used as a screening test
in accordance with the procedures set forth in Sec. 147.7.
(ii) For egg yolk samples being tested to retain the U.S. H5/H7
Avian Influenza Monitored classification, test the resultant
supernatant in accordance with the requirements in Sec. 146.13(b).
Note: For evaluating the test results of any egg yolk test, it
should be remembered that a 1:2 dilution of the yolk in saline was
made of the original specimen.
Sec. 147.45 [Amended]
0
11. Section 147.45 is amended by adding the words ``and for each of the
programs prescribed in subparts B, C, and D of part 146 of this
chapter'' after the word ``chapter''.
0
12. In Sec. 147.46, paragraph (a) is revised to read as follows:
Sec. 147.46 Committee consideration of proposed changes.
(a) The following committees shall be established to give
preliminary consideration to the proposed changes falling in their
respective fields:
(1) Egg-type breeding chickens.
(2) Meat-type breeding chickens.
(3) Breeding turkeys.
(4) Breeding waterfowl, exhibition poultry, and game birds.
(5) Breeding ostriches, emus, rheas, and cassowaries.
(6) Egg-type commercial chickens.
(7) Meat-type commercial chickens.
(8) Meat-type commercial turkeys.
* * * * *
Done in Washington, DC, this 20th day of September 2006.
Bruce Knight,
Under Secretary, Marketing and Regulatory Programs.
[FR Doc. 06-8155 Filed 9-25-06; 8:45 am]
BILLING CODE 3410-34-P