Low Pathogenic Avian Influenza; Voluntary Control Program and Payment of Indemnity, 56302-56333 [06-8155]

Agencies

• DEPARTMENT OF AGRICULTURE
• Animal and Plant Health Inspection Service

[Federal Register Volume 71, Number 186 (Tuesday, September 26, 2006)]
[Rules and Regulations]
[Pages 56302-56333]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-8155]



[[Page 56301]]

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Part IV





Department of Agriculture





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Animal and Plant Health Inspection Service



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9 CFR Parts 53, 56, 145, 146 and 147



Low Pathogenic Avian Influenza; Voluntary Control Program and Payment 
of Indemnity; Final Rule

Federal Register / Vol. 71, No. 186 / Tuesday, September 26, 2006 / 
Rules and Regulations

[[Page 56302]]


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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.

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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 https://
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 https://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
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                        Location                               Year
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Pennsylvania, United States.............................       1983-1984
Mexico..................................................       1994-1995
Italy...................................................            1999
Chile...................................................            2002
British Columbia, Canada................................            2004
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    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\
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    \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 https://
www.oie.int/eng/normes/mcode/en-- chapitre--2.1.1.htm#chapitre--
2.1.1.
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    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
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                                                             Number of
                          Years                              outbreaks
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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
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                 Location                       Year                           Virus subtype
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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

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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\
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    \2\ See ``WHO Avian influenza frequently asked questions'' at 
https://www.who.int/csr/disease/avian--influenza/avian--faqs/en/
index.html (as of August 11, 2006).
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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.
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    \3\ The recommendations may be viewed on the Internet at https://
www.oie.int/eng/normes/mcode/en--chapitre--2.7.12.htm.
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    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\
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    \4\ These guidelines may be viewed on the Internet at https://
www.oie.int/eng/normes/mcode/en--chapitre--3.8.9.htm#chapitre--
3.8.9.
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    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.)
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    \5\ See the Terrestrial Animal Health Code General Definitions 
at https://www.oie.int/eng/normes/mcode/en--chapitre--
1.1.1.htm#terme--compartiment.
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    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 p