Avian Influenza: USDA Has Taken Important Steps to Prepare for	 
Outbreaks, but Better Planning Could Improve Response (11-JUN-07,
GAO-07-652).							 
                                                                 
A highly pathogenic strain of avian influenza (AI) has spread to 
nearly 60 countries over the past few years, killing millions of 
birds and more than 170 humans. Controlling the virus in poultry 
is key to reducing the risk of a human pandemic. The Department  
of Agriculture (USDA) is responsible for planning for AI	 
outbreaks in poultry, with states' assistance. The Department of 
Homeland Security (DHS) is responsible for coordinating the	 
federal response for certain emergencies and developing policy	 
documents that serve as a basis for national emergency planning. 
GAO described the steps USDA is taking to prepare for highly	 
pathogenic AI and identified key challenges. GAO reviewed	 
response plans, statutes, and regulations; visited poultry	 
operations; interviewed federal, state, and industry officials in
five states that experienced outbreaks; and reviewed 19 state	 
plans.								 
-------------------------Indexing Terms------------------------- 
REPORTNUM:   GAO-07-652 					        
    ACCNO:   A70568						        
  TITLE:     Avian Influenza: USDA Has Taken Important Steps to       
Prepare for Outbreaks, but Better Planning Could Improve Response
     DATE:   06/11/2007 
  SUBJECT:   Animal diseases					 
	     Avian influenza					 
	     Birds						 
	     Emergency preparedness				 
	     Epidemics						 
	     Federal regulations				 
	     Federal/state relations				 
	     Homeland security					 
	     Infectious diseases				 
	     Pandemic						 
	     Poultry						 
	     Strategic planning 				 

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GAO-07-652

   

     * [1]Report to Congressional Committees

          * [2]June 2007

     * [3]AVIAN INFLUENZA

          * [4]USDA Has Taken Important Steps to Prepare for Outbreaks, but
            Better Planning Could Improve Response

     * [5]Contents

          * [6]Results in Brief
          * [7]Background
          * [8]USDA Is Implementing Important Measures to Help the Nation
            Prepare for Outbreaks of Highly Pathogenic Avian Influenza

               * [9]Import and Smuggling Control
               * [10]Surveillance
               * [11]Response Plans
               * [12]Exercising Response Plans
               * [13]National Veterinary Stockpile
               * [14]Indemnification
               * [15]Communications
               * [16]Research

          * [17]Federal and State Response Plans Are Incomplete, and Several
            Issues Are Unresolved

               * [18]USDA Has Not Planned for DHS' Lead Coordination Role
               * [19]USDA Has Not Identified Response Capabilities for Highly
                 Pathogenic AI
               * [20]Incomplete State Plans Could Slow Response
               * [21]Unresolved Issues Could Delay Response

          * [22]Conclusions
          * [23]Recommendations for Executive Action
          * [24]Agency Comments and Our Evaluation

     * [25]Scope and Methodology
     * [26]Comments from the Department of Agriculture

          * [27]GAO Comments

     * [28]Comments from the Department of Homeland Security
     * [29]GAO Contact and Staff Acknowledgments
     * [30]PDF6-Ordering Information.pdf

          * [31]Order by Mail or Phone

Report to Congressional Committees

June 2007

AVIAN INFLUENZA

USDA Has Taken Important Steps to Prepare for Outbreaks, but Better
Planning Could Improve Response

Contents

Tables

Figures

June 11, 2007

Congressional Committees:

A highly pathogenic strain of H5N1 avian influenza has, over the past few
years, spread to nearly 60 countries, resulting in the death and
destruction of millions of wild and domestic birds throughout Asia,
Europe, Africa, and the Middle East. Serious concerns exist that it could
reach North America at any time via migrating birds or smuggled imports of
diseased birds and bird products. Although primarily an avian disease,
this virus has also infected 291 humans--most of whom had close contact
with infected poultry--and more than half of them have died.^1 Health
experts are concerned that should highly pathogenic H5N1 (or another
subtype), to which humans have no immunity, develop the capacity to spread
easily from person to person, a pandemic could occur. According to the
World Health Organization, controlling the virus in poultry is the
principal way to reduce opportunities for human infection and, therefore,
reduce opportunities for a pandemic to emerge.

Avian influenza (AI) viruses are classified as either "low pathogenic" or
"highly pathogenic" based on their genetic features and the severity of
the disease they cause in poultry. Most AI viruses are low pathogenic and
usually result in mild or asymptomatic infections in birds. In the United
States, these viruses are common in wild waterfowl and shorebirds. Highly
pathogenic AI viruses are associated with high morbidity and mortality in
poultry and are considered foreign animal diseases because they rarely
occur in the United States. Despite the relative mildness of low
pathogenic AI, some of these strains are worrisome because they have the
potential to mutate into highly pathogenic AI. This happened most recently
in 2004 in British Columbia, Canada, resulting in the death of 17 million
birds.

The Department of Agriculture (USDA) is responsible for acting to prevent,
control, and eradicate foreign animal diseases in domestic livestock and
poultry, in coordination with a number of other entities. For example,
USDA typically partners with states and industry in eradicating such
diseases, with the agency's level of involvement dependent upon states'
preparedness and the size of the outbreak. If humans become infected, the
Department of Health and Human Services (HHS) leads the federal medical
response. In the event of an outbreak serious enough for the President to
declare an emergency^3 or for the Secretary of Homeland ^2 or major
disasterSecurity to declare an Incident of National Significance,^4 the
Secretary of Homeland Security assumes responsibility for coordinating the
federal response. In addition, the Department of Homeland Security (DHS)
has been charged with developing policy documents that provide the
foundation for emergency planning for all levels of government.

1These numbers are based on statistics reported by the World Health Organization as of
April 11, 2007.

A well-planned, coordinated emergency response is essential when dealing
with highly pathogenic AI in order to mitigate financial losses to the $28
billion U.S. poultry industry. The United States is the world's largest
producer and second largest exporter of poultry meat, accounting for
nearly 35 percent of global trade valued at more than $2 billion annually.
Once certain strains of low pathogenic AI or any strain of highly
pathogenic AI are found in domestic poultry in the United States, trading
partners are notified, and exports of poultry and poultry products from
within the affected area are halted. To control the spread of the disease
and to ultimately resume trade, USDA, often with assistance from states
and the poultry industry, typically destroys--depopulates--exposed and
infected birds, including those raised in commercial operations and in
backyards.^5

2The Robert T. Stafford Disaster Relief and Emergency Assistance Act, Pub. L. No. 93-288, 88
Stat. 143 (1974) (codified as amended at 42 U.S.C. ï¿½ï¿½ 5121 et seq.), defines an emergency as
ï¿½any occasion or instance for which, in the determination of the President, Federal
assistance is needed to supplement State and local efforts and capabilities to save lives and
to protect property and public health and safety, or to lessen or avert the threat of a
catastrophe in any part of the United States.ï¿½ 42 U.S.C. ï¿½5122(1).

3The Stafford Act defines a major disaster as ï¿½any natural catastrophe (including any
hurricane, tornado, storm, high water, winddriven water, tidal wave, tsunami, earthquake,
volcanic eruption, landslide, mudslide, snowstorm or drought), or, regardless of cause, any
fire, flood, or explosion, in any part of the United States, which in the determination of the
President causes damage of sufficient severity and magnitude to warrant major disaster
assistance under [the Act] to supplement the efforts and available resources of States, local
governments, and disaster relief organizations in alleviating the damage, loss, hardship, or
suffering caused thereby.ï¿½ 42 U.S.C. ï¿½5122(2).

4According to the National Response Plan, an Incident of National Significance is ï¿½an actual
or potential high-impact event that requires a coordinated and effective response by an
appropriate combination of Federal, State, local, tribal, nongovernmental, and/or privatesector
entities in order to save lives and minimize damage, and provide the basis for longterm
community recovery and mitigation activities.ï¿½

5Backyard birds are those raised, for example, for cockfighting or personal consumption.

USDA provides compensation to owners--indemnifies them--for losses
incurred when USDA depopulates birds.^6

6In addition, USDA may, under certain circumstances, indemnify owners when states and
industry depopulate birds.

USDA has had some experience working with states and the poultry industry
to eradicate highly pathogenic AI. For example, USDA worked with
Pennsylvania to control an outbreak of highly pathogenic AI in 1983,
leading to the depopulation of 17 million birds. However, the agency has
never confronted the challenge of an AI strain with the unique
characteristics of highly pathogenic H5N1: the unprecedented speed with
which it has spread, its human health implications, and the extensive
scrutiny it has received as a result of coverage in the world media.
Moreover, the possibility exists that terrorists could introduce highly
pathogenic AI at multiple locations, instilling fear in the public about
the safety of the food supply and disrupting the economy.

Given the intense global concern about highly pathogenic AI, we (1)
described the steps USDA has taken to prepare for highly pathogenic AI in
domestic poultry and (2) identified any challenges that could affect
USDA's ability to prepare for highly pathogenic AI. A list of
congressional committees that requested this report appears on the last
page of this letter.

To describe the steps USDA has taken to prepare for outbreaks of highly
pathogenic AI in domestic poultry, we reviewed presidential directives and
national emergency planning documents, relevant statutes and regulations,
and USDA documents and programs related to AI. To identify any challenges
that could affect USDA's ability to prepare for outbreaks of highly
pathogenic AI, we conducted structured interviews with federal, state, and
industry officials in California, Delaware, Maryland, Texas, and Virginia.
We selected these states because they have experience responding to an
outbreak of AI or another highly infectious avian disease in the past 5
years and because of their varying poultry demographics. We also
interviewed USDA emergency management and industry officials, including
those personnel specifically charged with helping states develop AI
response plans, to identify strengths and weaknesses in state plans and to
characterize their state's level of readiness for an outbreak. In
addition, we performed our own review and assessment of 19 state plans to
corroborate identified strengths and weaknesses from the interviews.
Furthermore, we attended a USDA and state AI training exercise and visited
live bird markets and numerous types of poultry operations. Finally, we
interviewed DHS officials to discuss emergency planning and DHS' role in
outbreaks of AI. Additional details about our scope and methodology are
presented in appendix I. We conducted our review between May 2006 and June
2007 in accordance with generally accepted government auditing standards.

6In addition, USDA may, under certain circumstances, indemnify owners when states and
industry depopulate birds.

Results in Brief

USDA is taking many important measures to help the nation prepare for
outbreaks of highly pathogenic AI. For example, USDA has put mechanisms in
place to prevent the importation of poultry and poultry products
contaminated with highly pathogenic AI. It also has developed several
surveillance programs to detect AI, including a long-standing voluntary
program that systematically tests samples of birds from participating
poultry operators' flocks for the virus. In addition, USDA is developing
response plans specific to highly pathogenic AI, and the department has
begun preliminary exercises with other federal agencies, states, and
industry to test preparedness. Moreover, USDA has begun creating a
National Veterinary Stockpile containing, among other things, personal
protective equipment such as goggles and respirators to protect responders
against foreign animal diseases. Furthermore, USDA recently expanded its
indemnification regulations and has developed communication strategies to
inform the public and instill confidence that USDA is taking steps to
quickly address any potential AI outbreak. Finally, USDA has critical AI
research under way. For example, it is conducting experiments to better
understand how the virus causes disease and death in some domestic poultry
and wild birds but not in others.

While USDA has made important strides, incomplete planning at the federal
and state levels, as well as several unresolved issues, could slow
response and delay recovery from an outbreak. First, USDA is not planning
for DHS to assume the lead coordinating role if an outbreak among poultry
occurs that is sufficient in scope to warrant a presidential declaration
of an emergency or major disaster, or a DHS declaration of an Incident of
National Significance. USDA officials told us that DHS involvement would
likely be unnecessary unless there are multiple outbreaks, an
agroterrorism event is suspected, or the virus causes a human pandemic.
Moreover, in the view of USDA officials, it is not clear that a
presidential declaration of an emergency or major disaster would even
apply to a highly pathogenic AI outbreak. However, the decision to involve
DHS is not USDA's to make. It is the President who declares an emergency
or major disaster when he determines that an outbreak is sufficient in
scope to warrant federal assistance. Furthermore, DHS officials told us
that it is possible that an Incident of National Significance would be
declared by the Secretary of Homeland Security depending on the severity,
magnitude, or complexity of the outbreak. In the event of a presidential
declaration of an emergency or major disaster, or a declaration of an
Incident of National Significance, the Secretary of Homeland Security
assumes responsibility for directing the federal response. DHS officials
told us they should be involved in planning for such an event. Our prior
work has shown that roles and responsibilities for those responding to
major incidents must be clearly defined and understood to facilitate rapid
and effective decision making. Because this DHS/USDA coordination is
absent from USDA planning, the federal response may be slowed as these
agencies resolve their roles and responsibilities following the onset of a
significant outbreak. Second, USDA response plans do not identify the
capabilities needed to carry out the tasks associated with an outbreak
scenario--that is, the entities responsible for carrying them out, the
resources needed, and the source of those resources. Planning of this
nature is essential for an effective emergency response.

Furthermore, 14 of 19 state plans that we reviewed lack important
components that could facilitate rapid containment of the virus. For
example, some lack time frames for accomplishing response activities that
would enable the states to determine the extent to which they were being
successful in controlling the outbreak. USDA and state officials told us
that state-level plans are incomplete for several reasons, including the
lack of established federal criteria for what a response plan for highly
pathogenic AI should include. In the absence of such criteria, USDA and
state officials we interviewed told us they are relying, among other
things, on experience from previous outbreaks. These planning gaps are
particularly problematic because states typically lead initial response
efforts, when rapid action is essential to limiting the spread of disease.

Finally, several unresolved issues could affect response. For example,
federal and state officials generally do not know the numbers and
locations of backyard birds so controlling an outbreak among these birds
remains particularly difficult. A recent California outbreak of exotic
Newcastle disease--a highly infectious foreign animal disease in
birds--illustrates this point. This virus originated in backyard flocks in
California and spread to two neighboring states. Controlling the disease
was impeded because responders had to go door-to-door to locate
potentially infected birds. A second issue is that the disposal of
carcasses and materials infected with AI may be more problematic than in
the past. State officials told us that in light of highly pathogenic H5N1,
operators of landfills have become reluctant to accept materials infected
with even low pathogenic AI because of the perceived human health risk.
Furthermore, USDA has not estimated the amount of antiviral medication
that it would need in the event of an outbreak or resolved how to provide
such supplies within the first 24 hours of an outbreak. According to
federal guidance, workers responding to an outbreak of highly pathogenic
AI should take antiviral medication daily at the site of an outbreak and
each day for 7 days after leaving the site to protect them from infection.

To increase the likelihood that an outbreak of highly pathogenic AI is
rapidly contained so efforts can focus on recovery, we are making several
recommendations. For example, we are recommending that the Secretaries of
Agriculture and Homeland Security develop a memorandum of understanding
that describes how USDA and DHS will work together in the event of a
declared presidential emergency or major disaster, or an Incident of
National Significance, and test the effectiveness of this coordination
during exercises. In addition, we are recommending that the Secretary of
Agriculture identify and test the capabilities necessary to respond to a
probable outbreak scenario(s); develop standard criteria for the
components of state response plans; focus additional work with states on
how to overcome potential problems associated with unresolved issues; and
address concerns about antiviral medication.

In commenting on a draft of this report, USDA agreed with all but one of
our recommendations. USDA stated that it does not believe a memorandum of
understanding is the best vehicle for clarifying and defining the roles of
USDA and DHS in the event of a declared presidential emergency or major
disaster, or an Incident of National Significance. Nevertheless, USDA
accepted the need to clarify the roles during such an event and further
supported the need to test this coordination in formal exercises. DHS
agreed that USDA and DHS roles need further clarification and suggested
that a concept of operation plan could be used to define this
relationship. DHS further supported the need to test this coordination
through exercises.

Background

In November 2005, the President of the United States released the Homeland
Security Council's National Strategy for Pandemic Influenza to guide the
country's overall effort to address the threat that highly pathogenic AI
could create a human pandemic influenza. The strategy identified four lead
agencies, each responsible for developing a plan to implement a component
of the strategy: USDA is responsible for the veterinary response, HHS is
responsible for the medical response, the Department of State is
responsible for international activities, and DHS is responsible for
overall domestic incident management and federal coordination. In May
2006, the Implementation Plan for the National Strategy for Pandemic
Influenza was issued to describe how the strategy would be implemented.
Specifically, this implementation plan describes more than 300 critical
actions that the appropriate federal agencies must carry out to address
the threat of pandemic influenza. The department has responsibility for
nearly 100 of these critical actions.^7

7According to USDA, the department is responsible for leading 57 of these critical actions
and supporting 41 more.

The U.S. poultry industry consists, in large part, of a relatively small
number of large companies that own all aspects of the production
process--from the hatchery to the processing facility. The most common
types of poultry raised commercially are chickens for consumption (called
broilers) and chickens that lay eggs (called layers), as well as turkeys
(see fig. 1). Broilers represent 93 percent of poultry produced in the
United States (see fig. 2) and almost three-quarters of poultry and
poultry products by value sold to consumers (see fig. 3). There are also
commercial birds that are genetic breeding stock whose main function is to
produce offspring that facilitate mass production and are economical to
raise. Commercial poultry operations typically raise tens of thousands of
birds in confined poultry houses. Such operations can include multiple
houses located close to each other. Because of the environment in which
commercial birds are raised, if one bird becomes infected with highly
pathogenic AI, hundreds of thousands of birds can be exposed and need to
be depopulated.

7According to USDA, the department is responsible for leading 57 of these critical actions
and supporting 41 more.

Figure 1: Common Types of Commercial Poultry Operations

Figure 2: Percentages of Poultry Types Produced in the United States, 2005

Figure 3: Value of Poultry Products in the United States, 2005

In addition to poultry raised commercially, numerous types of birds are
raised in backyards, with flocks up to 1,000 birds. These "backyard" birds
are typically chickens used for personal egg production and consumption;
game fowl used for fighting; and game birds, such as quail and pheasant.
These birds may run loose or be confined to a poultry house. In addition,
there are birds in live bird markets--facilities that sell live poultry,
which is often slaughtered on-site, to the general public--and some are
sold at auctions and swap meets.

When poultry become infected with AI, it may be spread by the movement of
contaminated people and equipment to and from a site where the infected
birds are located (see fig. 4). For example, a poultry worker enters one
bird house containing birds infected with AI but does not disinfect boots
or change clothing before entering another house, carrying the virus and
causing the disease to spread. As a precaution, commercial producers often
implement biosecurity measures. For example, the number of people entering
a bird house is restricted, and these people must dress in special,
sometimes disposable, clothing. Moreover, vehicles arriving at a farm are
usually required to be disinfected upon entry and exit. The workers' boots
and hands are also disinfected. For highly valuable birds, such as genetic
breeding stock, biosecurity may be higher--for example, visitors may be
required to shower before entering and leaving the facility.

Figure 4: How Disease Spreads Among Commercial Poultry

Despite biosecurity measures, outbreaks among commercial poultry have
recently occurred (see table 1). For example, in 2002, Virginia
experienced an outbreak of low pathogenic AI that resulted in the
depopulation of nearly 5 million birds in order to control the disease.^8
In 2003, Connecticut had an outbreak of low pathogenic AI that affected
more than 3 million commercial laying hens.^9 While low pathogenic AI is
detected from time to time in domestic poultry, highly pathogenic AI is
known to have occurred only three times in the United States: in 1924,
1983, and 2004. It is believed that all three of these highly pathogenic
outbreaks originated in live bird markets. The Pennsylvania outbreak in
1983 began as a low pathogenic AI virus but mutated into a highly
pathogenic strain, leading to the depopulation of 17 million birds.
Although diagnostic testing confirmed that a virus in Texas in 2004 was
technically highly pathogenic, the virus did not cause high mortality in
the infected birds, as would be typical with highly pathogenic AI.

Table 1: States That Have Experienced Outbreaks of Avian Influenza in
Commercial Poultry Since 2002

                                        

         State         Avian     Year of     Origin     Number/type    Time    
                      disease   outbreak                 of birds    taken to  
                                                        depopulated  eradicate 
Virginia/North    Low            2002  Unconfirmed; 4.7 million   4 months  
Carolina/West     pathogenic           live bird    birds                   
Virginia          AI                   market                               
                                          suspected                            
Connecticut       Low            2003  Unconfirmed; 100,000       Over 1    
                     pathogenic           wildfowl     laying hens;  year      
                     AI                   suspected    millions more           
                                                       vaccinated              
Delaware/Maryland Low            2004  Live bird    More than     2 months  
                     pathogenic           market       400,000                 
                     AI                                commercial              
                                                       broilers                
Texas             Highly         2004  Live bird    6,600         Less than 
                     pathogenic           market       commercial    2 months  
                     AI                                broilers                
West Virginia^a   Low            2007  Unknown at   25,000        Unknown   
                     pathogenic           this time    turkeys       at this   
                     AI                                              time      
                     suspected                         (unconfirmed)           

Source: GAO.

^aOn March 31, 2007, USDA confirmed the presence of an H5N2 AI virus in
turkeys located on a farm in West Virginia. USDA reported that this virus
is consistent with low pathogenic strains of AI. The turkeys showed no
signs of illness, and there was no mortality. USDA plans to run sequencing
and pathogenicity tests to further identify the virus.

8Poultry in North Carolina and West Virginia were also affected.

9In this instance, vaccines were used in conjunction with depopulation to control the
outbreak.

An outbreak of AI can have serious trade repercussions. The World
Organization for Animal Health is an international animal health group
with 167 member countries, including the United States. Members agree to
notify the organization of outbreaks in domestic poultry of all highly
pathogenic AI and some low pathogenic strains--those with H5 and H7
proteins--because they have the capacity to mutate into highly pathogenic
AI.^10 Consequently, when a country's poultry tests positive for
"notifiable" AI, its international trading partners are likely to restrict
trade with that country until the partners believe the virus is
eradicated--an outcome that can take many months to achieve. For example,
when a single farm in Texas was infected with highly pathogenic AI in
2004, more than 50 countries instituted complete or partial bans on U.S.
poultry; Mexico has yet to lift its ban. Therefore, when a flock is
infected with AI, the goal becomes controlling and eradicating the disease
as rapidly as possible in order to prevent the spread of the disease and
to regain the confidence of U.S. trading partners that any future imports
will be disease free. This is accomplished by acting quickly in the
affected area to, among other things: (1) quarantine susceptible animals;
(2) implement biosecurity measures; (3) depopulate infected and exposed
birds; (4) dispose of contaminated and potentially contaminated materials,
including animal carcasses; and (5) clean and disinfect the infected
premises. Once the disease is eradicated, USDA, states, and the poultry
industry continue to test birds to monitor for AI.

USDA derives its authority to carry out operations and measures to
prevent, detect, control, and eradicate AI from the Animal Health
Protection Act.^11 The act authorizes the Secretary of Agriculture to
hold, seize, treat, destroy, or dispose of any animal, vehicle, or object
that can harbor the disease, or to restrict their movement in interstate
commerce. The act also authorizes the Secretary to transfer funds from
other USDA appropriations or available funds to manage an emergency in
which a disease of livestock threatens any segment of agricultural
production in the United States. In addition, the act authorizes the
Secretary to declare an "extraordinary emergency" when it has been
determined that a state's actions are inadequate to control or eradicate a
livestock disease that threatens domestic livestock. Under this
declaration, the Secretary's authority to regulate includes any animal,
vehicle, or object that can harbor the disease in intrastate, as well as
interstate commerce.

10The World Organization for Animal Health defines notifiable AI 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 with at least 75 percent mortality.

117 U.S.C. ï¿½ï¿½ 8301-8321.

Within USDA, a number of agencies have responsibility for protecting U.S.
poultry from AI. The Animal and Plant Health Inspection Service (APHIS)
operates the National Veterinary Services Laboratories, the only
laboratory in the United States recognized by the World Organization for
Animal Health to perform confirmatory testing for AI. Also, APHIS'
Smuggling, Interdiction, and Trade Compliance unit conducts activities to
prevent smuggled and prohibited agricultural goods from entering and being
distributed throughout the country. In addition, the Agricultural Research
Service conducts research on endemic and exotic poultry diseases,
including highly pathogenic AI; the Food Safety and Inspection Service
works to ensure that the nation's commercial supply of meat, poultry, and
egg products is safe for human consumption; the Office of Communications
coordinates public information from USDA program agencies.

In the past few years, USDA's total obligations for AI preparedness
efforts have increased from approximately $3.2 million in fiscal year 2004
to $74.1 million in fiscal year 2006. In 2005, USDA received $91.35
million from the 2-year Emergency Supplemental Appropriation to Address
Pandemic Influenza.^12 The bulk of USDA's supplemental funding ($80.3
million) was allocated to APHIS, which in turn obligated $43 million for
AI surveillance of domestic wildlife, commercial poultry, and live bird
markets in fiscal year 2006.^13 In addition, USDA obligated portions of
the remaining emergency supplemental funding to areas such as AI research
and public communications. According to USDA officials, the department is
requesting $82 million for fiscal year 2008 to support its ongoing AI
programs.

While USDA has for many years been responsible for protecting livestock
and poultry from foreign animal diseases, it now does so under new
authorities and has additional roles and responsibilities. Following the
terrorist attacks of 2001, the Congress passed the Homeland Security Act
of
2002,^14 establishing DHS as the chief coordinating agency for efforts to
protect the United States from terrorist acts and disasters, including
those that affect the agriculture sector. As such, DHS undertook major
policy initiatives to promote emergency preparedness, including developing
the National Incident Management System, the National Response Plan, and
the National Preparedness Goal.

12Pub. L. No. 109-148, div. B, tit. II, 119 Stat. 2782 (2005).

13The $80.3 million allocated to APHIS consisted of $71.5 million from the 2-year emergency
supplemental and, according to USDA officials, $8.8 million from supplemental funds
appropriated to the Office of the Secretary.

The National Incident Management System is intended to provide a
consistent framework for incident management at all jurisdictional levels
regardless of cause, size, or complexity of the situation and to define
the roles and responsibilities of federal, state, and local governments
during an emergency event. A key component of this system is the Incident
Command System, designed to coordinate the communications, personnel, and
procedures of different agencies and levels of government within a common
organizational structure during an emergency.

The National Response Plan is an all-hazards plan built on the template of
the National Incident Management System. It established a single,
comprehensive approach to domestic incident management to prevent, prepare
for, respond to, and recover from terrorist attacks, major disasters, and
other emergencies. The National Response Plan is stated to always be in
effect. Under the National Response Plan, resources are grouped into
Emergency Support Functions that would most likely be needed during a
domestic incident. Under Emergency Support Function #11, which addresses
the protection of agriculture, APHIS is responsible for implementing an
integrated federal, state, tribal, and local response to an outbreak of a
highly contagious or economically devastating animal disease, such as
highly pathogenic AI. A fundamental principle of the National Response
Plan is that incidents are first handled at the lowest possible level of
government. If an incident overwhelms local and state capabilities, a
state may request resources from other states through mutual aid
agreements, or may request federal assistance. The Robert T. Stafford
Disaster Relief and Emergency Assistance Act ^15 established the process
for states to request supplemental resources from the federal government
when state and local resources have been or will be overwhelmed. The
President invokes a federal response under the Stafford Act by declaring
an "emergency" or a "major disaster."

14Homeland Security Act of 2002, Pub. L. No. 107-296, 116 Stat. 2135.

15Pub. L. No. 93-288, 88 Stat. 143 (1974) (codified as amended at 42 U.S.C. ï¿½ï¿½ 5121 et seq.).

Homeland Security Presidential Directive 8 required the Secretary of
Homeland Security to coordinate the development of a national domestic
all-hazards preparedness goal to establish measurable readiness priorities
and targets that appropriately balance the potential threat and magnitude
of terrorist attacks and major disasters with the resources required to
prevent, respond to, and recover from them. The goal was to include
standards for preparedness assessments and strategies and a system for
assessing the nation's overall preparedness to respond to major events. To
implement this directive, DHS developed the National Preparedness Goal
using 15 emergency event scenarios^16 whose purpose was to form the basis
for identifying the capabilities needed to respond to a wide range of
emergency events.^17 One of the defined scenarios was an outbreak of a
foreign animal disease.

Finally, Homeland Security Presidential Directive 9 established a national
policy to defend the agriculture and food system against terrorist
attacks, major disasters, and other emergencies. Specifically, it directs
the Secretary of Agriculture, in coordination with the Secretary of
Homeland Security, and in consultation with the Secretary of Health and
Human Services and the Administrator of the Environmental Protection
Agency,^18 to work with state and local governments and the private sector
to develop a National Veterinary Stockpile containing sufficient amounts
of animal vaccine, antiviral, or therapeutic products to appropriately
respond to the most damaging animal diseases affecting human health and
the economy within 24 hours of an outbreak.

16The 15 scenarios are (1) improvised nuclear device attack, (2) aerosol anthrax attack, (3)
pandemic influenza, (4) biological attack with plague, (5) chemical attack with blister agent,
(6) chemical attack with toxic chemical agent, (7) chemical attack with nerve agent, (8)
chemical attack resulting in chlorine tank explosion, (9) major earthquake, (10) major
hurricane, (11) radiological attack with dispersal device, (12) improvised explosive device
attack, (13) biological attack with food contamination, (14) biological attack with foreign
animal disease, and (15) cyber attack.

17Capabilitiesï¿½the ability to carry out specific tasks under particular conditions with
desired resultsï¿½are built upon the appropriate combination of people, skills, processes,
and assets.

18The mission of the Environmental Protection Agency is to protect human health and the
environment.

USDA Is Implementing Important Measures to Help the Nation Prepare for
Outbreaks of Highly Pathogenic Avian Influenza

USDA has taken important steps to prepare for highly pathogenic AI. For
example, the department has put mechanisms in place to prevent the
importation of infected poultry and poultry products. In addition, it has
developed several surveillance programs to detect AI. Moreover, in the
event outbreaks do occur, USDA is developing written response plans and
has begun preliminary exercises to test aspects of these plans with
federal, state, local, and industry partners. USDA has also begun creating
a National Veterinary Stockpile to augment state and local resources
during outbreaks. Finally, the department has recently expanded its
indemnification coverage for AI, developed public service messages to
provide accurate information during outbreaks, and has undertaken critical
AI research.

Import and Smuggling Control

Trade in live poultry and its products and the smuggling of birds and bird
products have played a large role in the spread of highly pathogenic
H5N1.^19 To counteract these threats, USDA has mechanisms in place to
prevent the importation of infected poultry and poultry products. For
example, APHIS maintains trade restrictions on the importation of poultry
and its products originating from regions where highly pathogenic AI has
been detected. APHIS also requires that all live birds imported into the
United States, with the exception of those from Canada, spend 30 days at a
USDA quarantine facility where they are tested for AI. If found positive
for the virus, the bird is destroyed.

In addition, APHIS' Smuggling, Interdiction, and Trade Compliance unit has
increased its monitoring for smuggled poultry and products through an
antismuggling program in coordination with DHS.^20 Specifically, during
fiscal year 2006 and the first 2 months of 2007, it conducted a total of
54 special AI operations. For example, at the Port of Los Angeles/Long
Beach, this unit conducted an operation that targeted poultry and
associated products that were being brought into the United States for the
Asian New Year, when Asian imports typically increase. A total of 15 cargo
inspections were conducted, and 4,324 kilograms of prohibited poultry
products (including products from China and Japan, which were experiencing
outbreaks of highly pathogenic H5N1 at the time of this report) were
discovered. USDA has recently hired more than 20 field officers and eight
analysts that specialize in AI to enhance surveillance and target
potential AI shipments. Furthermore, in the spring of 2007, USDA officials
told us that it will launch a national public awareness campaign to raise
awareness among importers, distributors, wholesalers, and other key
stakeholders about the threat of AI in smuggled poultry.

19Report of the Second FAO/OIE Regional Meeting on Avian Influenza Control in Asia, in
collaboration with: Government of Viet Nam (Ministry of Agriculture and Rural
Development) and World Health Organization, February 23-25, 2005.

20Coordination with DHS is necessary because the Homeland Security Act of 2002, Pub. L.
No. 107-296, 116 Stat. 2135, transferred most of USDAï¿½s responsibility for conducting
agricultural import inspections to DHS. (See GAO, Homeland Security: Much Is Being
Done to Protect Agriculture from a Terrorist Attack, but Important Challenges Remain,
GAO-05-214 (Washington D.C.: Mar. 8, 2005).

Surveillance

USDA has several surveillance programs intended to rapidly detect and
prevent the spread of AI. These programs augment USDA's veterinary
infrastructure--an infrastructure that provides the foundation for USDA
foreign animal disease monitoring. For example, APHIS' long-standing
voluntary program, the National Poultry Improvement Plan, tests
participating commercial poultry flocks to ensure they are free from
diseases, including AI. If flocks test negative for AI, USDA provides
certification that the flock is free of the disease,^21 thereby assisting
with interstate and international trade, which provides an incentive for
commercial industry participation. Forty-eight states participate in this
program. In addition, APHIS' Biosecurity for the Birds program encourages,
among other things,^22 surveillance of backyard birds. APHIS works closely
with state departments of agriculture, USDA's Cooperative Extension
Service, and private veterinarians to make information available to
backyard bird owners on the risks and signs of disease and good
biosecurity practices. While this program does not include a testing
component, APHIS offers the public a toll-free number to notify
authorities when backyard birds become sick and die. USDA is also
expanding its surveillance programs as required in the Implementation Plan
for the National Strategy for Pandemic Influenza. For example, among other
efforts, APHIS is working with the Department of the Interior,^23 state
wildlife agencies, and others to increase surveillance of wild birds in
Alaska and the 48 continental states. Moreover, USDA is working with
states and industry to conduct surveillance of birds at auctions, swap
meets, flea markets, and public exhibitions. Furthermore, in 2002, USDA
established the National Animal Health Laboratory Network as part of a
national strategy to coordinate and link the testing capacities of the
federal veterinary diagnostic laboratories with the extensive
infrastructure of state and university capabilities. This network now
includes 51 approved
laboratories that partner to conduct enhanced AI surveillance efforts.^24
Finally, APHIS recently formed the National Avian Influenza Surveillance
System, designed to link existing AI surveillance data from USDA, other
federal and state agencies, and industry.

21The certification USDA provides indicates that breeder flocks are ï¿½AI cleanï¿½ and that
production flocks are ï¿½AI monitored.ï¿½

22For example, this educational program also encourages good biosecurity practices among
backyard bird owners.

23The Department of Interior is responsible for managing healthy wildlife populations.

No. 107-296, 116 Stat. 2135, transferred most of USDAï¿½s responsibility for conducting
agricultural import inspections to DHS. (See GAO, Homeland Security: Much Is Being
Done to Protect Agriculture from a Terrorist Attack, but Important Challenges Remain,
GAO-05-214 (Washington D.C.: Mar. 8, 2005).

Response Plans

APHIS is currently drafting response plans for highly pathogenic AI.^25
For example, its draft Summary of the National Highly Pathogenic Avian
Influenza Response Plan describes the activities that are necessary to
respond to an outbreak.^26  In addition, USDA is working with the White
House Homeland Security Council and other key federal agencies to produce
an "interagency playbook"^27 intended  to clarify how primary federal
responders would initially interact to respond to six scenarios: detection
of highly pathogenic H5N1 (1) in wild birds, (2) in a commercial poultry
flock, (3) in multiple commercial poultry flocks within the United States,
(4) in a live bird market, (5) along a contiguous border, and (6)
involving a single case of poultry-to-human infection. According to the
interagency playbook, although USDA is the federal department primarily
responsible for controlling the disease in poultry (or other livestock),
it would work with other federal partners. For example, HHS would ensure
that systems were in place to detect and monitor infection in humans. In
addition, the Environmental Protection Agency would provide expertise on
disinfecting and disposing of materials; the Department of Labor,^28 in
conjunction with HHS, would provide guidance on how to protect workers,
including the use of personal protective equipment; and DHS would monitor
outbreak and intelligence information to determine if an outbreak was
bioterrorism-related.

24For more information on the National Animal Health Laboratory Network, see GAO,
Homeland Security: Much Is Being Done to Protect Agriculture from a Terrorist Attack,
but Important Challenges Remain, GAO-05-214 (Washington D.C.: Mar. 8, 2005).

25According to USDA, these draft AI documents have undergone intense development and
would be used as a basis for activities that the department would undertake in the event of
an outbreak of highly pathogenic AI.

26This plan summarizes APHISï¿½ National Highly Pathogenic Avian Influenza Preparedness
and Response Plan, which the agency describes as a strategic plan for rapidly detecting and
responding to highly pathogenic AI. The summary and the original plan are based on APHISï¿½
National Animal Health Emergency Management System, which provides guidance on
mitigating, preparing for, responding to, and recovering from major animal health
emergencies. Among other things, the system contains guidance for responding to highly
contagious foreign animal diseases and uses foot-and-mouth disease as its example.

27The playbook is entitled the Interagency Playbook for Domestic Response to a Detection
of Highly Pathogenic Avian Influenza H5N1 in Birds.

28Within the Department of Labor, the Occupational Safety and Health Administration
assures the safety and health of Americaï¿½s employees.

Exercising Response Plans

USDA has begun conducting preliminary tabletop exercises^29 on aspects of
response plans with other federal agencies, as well as states and private
industry, to gain a greater understanding of preparedness for highly
pathogenic AI. For example, APHIS conducted tabletop exercises with two
large poultry producing states to help identify the type and level of
personal protective equipment necessary to respond to an outbreak.
Industry officials were also present at these exercises, since the
selected scenarios identified outbreaks in commercial operations in both
states. In addition, USDA's Food Safety Inspection Service conducted five
tabletop exercises with state and local public health and emergency
response officials to test the operability and efficacy of its response
procedures against deliberate contamination of the food supply, as well as
against an AI outbreak. Moreover, the Food Safety Inspection Service and
APHIS conducted a joint tabletop exercise that simulated an outbreak of
highly pathogenic H5N1 in commercial poultry, backyard flocks, live bird
markets, and wild bird populations. Other participants included officials
from DHS and HHS; officials from four states; representatives from the
National Association of County and City Health Officials,^30 the National
Association of State Departments of Agriculture,^31 and the Association of
State and Territorial Health Officials^32; representatives of consumer
groups and industry officials; and representatives from the Canadian Food
Inspection Agency.

29A tabletop exercise is a group discussion guided by a scenario-based, simulated disaster.

30The National Association of County and City Health Officials is the national organization
representing local health departments.

31The National Association of State Departments of Agricultureï¿½s mission is to represent the
state departments of agriculture in the development, implementation, and communication
of sound public policy and programs that support and promote the American agricultural
industry, while protecting consumers and the environment.

32The Association of State and Territorial Health Officials is a national nonprofit
organization representing the state and territorial public health agencies of the United
States, the U.S. territories, and the District of Columbia.

Moving forward, APHIS is contracting with the Center for Naval Analysis to
develop and implement up to 60 additional tabletop exercises of state
response plans in the coming year. Once these exercises are conducted, the
agency intends to analyze the outcomes and identify areas that need
further improvement.

National Veterinary Stockpile

In coordination with DHS and others, APHIS has begun creating a National
Veterinary Stockpile. This stockpile is intended to be the nation's
repository of animal vaccines, personal protective equipment, and other
critical veterinary products to respond to the most dangerous foreign
animal diseases. The National Veterinary Stockpile's goal is to acquire
countermeasures against the 10 animal diseases that pose the greatest
threat, including highly pathogenic AI, within 5 years, and against an
additional 7 of these diseases within 10 years.^33 To accomplish this
task, National Veterinary Stockpile officials have begun building an
infrastructure to identify, acquire, store, maintain, manage, and deploy
this critical inventory within 24 hours of a foreign animal disease
outbreak, as required by the directive.^34 The stockpile currently owns
material sufficient to produce 140 million doses^35 of H5 and H7 AI
vaccine to protect older birds.^36 According to USDA officials, the
current inventory also includes 31 "push packs"--that is, ready-to-ship
containers stocked with a variety of personal protective equipment and
veterinary supplies, such as disinfectants; protective clothing (e.g.,
respirators, face masks, and protective body suits); and ancillary
supplies (e.g., decontamination fluid for responders to clean their
boots). Each push pack contains enough materials to support 10 outbreak
responders for 10 days.^37  According to USDA officials, the National
Veterinary Stockpile successfully tested its capability to deploy its
critical inventory by sending push packs to West Virginia for the
suspected low pathogenic AI outbreak that occurred in March of 2007.

33The 17 critical animal diseases were selected based on the following factors: whether or
not the disease-causing organism is highly contagious; the extent of its ability to rapidly
spread and infect many species; the extent of its ability to cause disease in humans; and its
economic impact both domestically and on trade.

34Homeland Security Presidential Directive 9, at ï¿½ 18.

35This exceeds the target in the Implementation Plan for the National Strategy for
Pandemic Influenza.

36Stockpile officials evaluated the feasibility of acquiring ready-to-use vaccine(s); costs of
purchasing them; and other life-cycle costs, such as storage, expiration, replacement, and
disposal. As a result, the National Veterinary Stockpile has adopted a strategy of maintaining
a limited supply of vaccine on hand but has purchased guaranteed access to larger amounts.
For example, the stockpile also has access to 500 million doses of vaccine to protect
younger chickens 1 to 7 days old. The stockpile has guaranteed access to 25 million doses
within 24 hours, with the remainder to follow, if necessary.

Indemnification

USDA recently decided to provide compensation for losses incurred as a
result of low pathogenic strains of H5 and H7 because of their potential
to mutate to highly pathogenic AI. Indemnification is provided, in part,
to encourage the early reporting of outbreaks and participation in
response efforts. For many years, USDA provided compensation for losses
incurred when birds were destroyed because of AI only when they were
infected with or exposed to a highly pathogenic strain.^38  Under the new
indemnity regulations for H5/H7 low pathogenic AI,  ^39 large commercial
poultry facilities must participate in USDA's National Poultry Improvement
Plan's AI surveillance program,^40 through a cooperating state agency, in
order to be eligible to receive 100 percent indemnity for destroyed
birds.^41 Large commercial facilities that do not participate in the
surveillance program
may receive only 25 percent indemnity.^42 These new regulations also
explicitly allow greater flexibility than the regulations for highly
pathogenic AI, which, for example, state that a USDA official must
appraise the value of destroyed poultry.^43 Under the new regulations,
this requirement may be waived in order to expedite response to large
outbreaks when USDA appraisers may be in short supply. Under these
circumstances, USDA may allow USDA-authorized state appraisers, in
addition to USDA appraisers, to conduct appraisals.^44 In addition, USDA
has included revised and very broad indemnity guidelines within its draft
summary response plan to allow for a more flexible indemnification process
during a highly pathogenic AI outbreak.

37This acquisition of push packs was based, in part, on available funds, rather than a
calculation based on outbreak scenarios. The National Veterinary Stockpile is in the process
of acquiring additional personal protective equipment (enough to support 1,500 responders
changing five times per day for 40 days).

38Foot-and-Mouth Disease, Pleuropneumonia, Rinderpest, and Certain Other Communicable
Diseases of Livestock or Poultry, 9 C.F.R. pt. 53. Indemnification has been provided under
these regulations when the affected states had entered into cooperative agreements with
USDA. Although these regulations do not generally provide indemnity for low pathogenic
strains, on two occasions, USDA did so by amending the regulations.

39For complete low pathogenic AI indemnity rules and regulations, see Low Pathogenic
Avian Influenza; Voluntary Control Program and Payment of Indemnity, 71 Fed. Reg. 56,302
(Sept. 26, 2006) (codified at 9 C.F.R. pt. 56).

40In addition, the states in which the facilities participate must conduct passive surveillance
and have an initial state response and containment plan.

41For commercial poultry, a participating flock or slaughter plant is required to participate in
the active surveillance program only if they are larger than a certain size standard. For tableegg
layer flocks, the standard is 75,000 birds. For meat-type chicken slaughter plants, the
standard is slaughtering 200,000 meat-type chickens in an operating week, while for meattype
turkey slaughter plants, the standard is slaughtering 2 million meat-type turkeys in a 12-
month period.

Communications

USDA's Office of Communications has developed risk communication messages
about highly pathogenic AI.^45 According to USDA officials, the goal of
these messages is to provide accurate, timely, and consistent information
during an outbreak; minimize public panic and fear; and instill public
confidence in the government's ability to respond to an outbreak.
Specifically, USDA, in partnership with HHS, the Department of the
Interior, and DHS, developed three scenarios for the detection of highly
pathogenic AI in the United States: (1) a highly pathogenic AI detection
in the United States other than H5N1, (2) highly pathogenic H5N1 in wild
birds, and (3) highly pathogenic H5N1 in commercial poultry. Each of these
scenarios contains a series of key questions and answers about animal
health and guidance for the public, as well as a summary of the actions
USDA would take. USDA has placed these messages, as well as key fact
sheets on its Web site for public viewing. The agency has also developed
public service announcements for television and radio and, according to
USDA, these messages have reached 175 markets and have been broadcast over
1,100 times.

42Backyard birds are eligible for 100 percent indemnification without participating in the
National Poultry Improvement Plan surveillance program because, according to USDA
officials, participation would be too burdensome; it is more important that there be an
incentive for these owners to report sick birds.

439 C.F.R. ï¿½ 53.3.

44Officials at USDAï¿½s Office of General Counsel told us that the Secretary of Agriculture,
under the authority of the Animal Health Protection Act, also retains this flexibility for
indemnification procedures for highly pathogenic AI. Under the Animal Health Protection
Act, the Secretary may authorize the destruction or disposal of certain animals he has
reason to believe may carry, have carried, have been affected, or have been exposed to an
animal disease. 7 U.S.C. ï¿½ 8306(a), (b). The Secretary is further authorized to compensate
the owner for any animals that he requires to be destroyed. 7 U.S.C. ï¿½ 8306(d).

45These messages were created in response to the Implementation Plan for the National
Strategy for Pandemic Influenza, which identified their development as a critical action
item.

Research

USDA is concentrating its AI research efforts on areas it considers
critical to prepare for outbreaks of highly pathogenic AI.^46 For example,
the Agricultural Research Service is testing currently available poultry
AI vaccines to determine if they are protective against highly pathogenic
H5N1; developing new vaccines to protect against AI viruses that can be
efficiently administered to large number of birds at once, such as through
aerosol; enhancing diagnostic tools^47 to allow for rapid testing of wild
bird samples; sequencing the genomes--a complete set of hereditary
factors--of 1,000 AI viruses in order to better understand the
epidemiology, or causes, of the diseases; and conducting experiments in
birds to better understand how the virus causes disease and death in some
domestic poultry and wild birds but not in others.

In addition, the Agricultural Research Service is collaborating with
several other federal agencies on AI research. For example, it worked with
USDA's Food Safety and Inspection Service to develop a test to determine
the presence of highly pathogenic AI in poultry meat. It has also been
working with the Environmental Protection Agency to research the ability
of residual chlorine in drinking water to deactivate the highly pathogenic
H5N1 virus. In addition, the Agricultural Research Service has been
assisting HHS with the development of a vaccine for use during a human
outbreak.

USDA's AI research efforts also focus on swine. For example, the
Agricultural Research Service is supporting DHS in determining how highly
pathogenic H5N1 viruses transmit to poultry and mammalian models. This is
important because, although highly pathogenic H5N1 is predominantly a
disease in poultry and wild birds, dogs, cats, and swine have also become
infected.^48 Swine are particularly worrisome because they can become
infected with not only swine influenza viruses but also human and avian
influenza viruses as well. The World Health Organization cautions that
pigs could play a role in the potential emergence of a pandemic virus.

46Many of these items are tasks identified in the Implementation Plan for the National
Strategy of Pandemic Influenza.

47These are reverse transcription polymerase chain reaction diagnostic tests.

Federal and State Response Plans Are Incomplete, and Several Issues Are
Unresolved

Despite actions taken by USDA, incomplete plans and unresolved issues
could slow outbreak response. Currently, USDA is not planning for the lead
coordinating role that DHS would assume in certain outbreak emergencies.
In addition, USDA's response plans do not identify the capabilities needed
to carry out critical tasks for controlling highly pathogenic AI
outbreaks. Furthermore, state plans are lacking key components for
facilitating a rapid response. Finally, several unresolved issues could
further delay response.

48According to the Food and Agriculture Organization of the United Nations, all carnivores
could become infected through eating infected poultry or infected wild birds.

49GAO, Catastrophic Disasters: Enhanced Leadership, Capabilities, and Accountability
Controls Will Improve the Effectiveness of the Nationï¿½s Preparedness, Response, and
Recovery System, GAO-06-618 (Washington, D.C.: Sept. 6, 2006).

USDA Has Not Planned for DHS' Lead Coordination Role

USDA is not planning for DHS to assume the lead coordinating role if an
outbreak among poultry occurs that warrants a presidential declaration of
an emergency or major disaster, or a DHS declaration of an Incident of
National Significance. USDA officials told us that DHS will not likely be
needed to perform this coordinating role unless there are multiple
outbreaks, an agroterrorism event is suspected, or the virus causes a
human pandemic. However, USDA's draft interagency playbook includes a
scenario involving multiple outbreaks without addressing this DHS
coordinating role. USDA officials also cite years of experience
eradicating foreign animal diseases as the reason for not needing DHS
involvement. Moreover, some officials told us that many within the agency
are concerned that DHS officials at the operational level of response
would not limit DHS involvement to that detailed in the National Response
Plan but would instead take over the veterinary response as well. Our
prior work^49 has shown that roles and responsibilities at all levels of
government must be clearly defined, effectively communicated, and well
understood to facilitate rapid and effective decision making during an
emergency. If this is not the case, problems such as those that plagued
response during past disasters could result.

Although USDA believes the need for DHS coordination is unlikely, the
decision to involve DHS is not USDA's to make. Specifically, a
presidential declaration of an emergency or major disaster is made by the
President of the United States at the request of state governors via the
Stafford Act, and such declarations require the Secretary of Homeland
Security to assume responsibility for directing the federal response.
State officials told us that their governors would consider making such a
request. For example, in 2000, a presidential declaration of emergency was
declared for the West Nile virus outbreak in New York state.^50 DHS
lawyers are in the process of determining the applicability of a
declaration to an outbreak of highly pathogenic AI; therefore, this
possibility should not be disregarded.

Moreover, the Secretary of Homeland Security has the discretion to declare
an Incident of National Significance. The National Response Plan states
that the Secretary of Homeland Security, in consultation with other
departments and agencies, and the White House, as appropriate, may make
such a declaration on the basis of criteria noted in Homeland Security
Presidential Directive 5,^51 including in the event of a presidential
declaration under the Stafford Act. However, the Secretary is not limited
to these criteria and may consider other factors when making this
decision. The determining factor is whether the incident is of such
severity, magnitude, or complexity that it requires the Secretary of
Homeland Security to manage the federal response. DHS officials told us
that if highly pathogenic H5N1 arrived in the United States, the Secretary
of Homeland Security would, in consultation with the White House and
cabinet members, consider declaring an Incident of National Significance
if its impact warranted one. DHS officials further noted that the economic
impact to the agriculture industry would be huge if the virus spread
across multiple states, making it imperative to prevent this from
happening. DHS officials told us that they hope that USDA will have the
ability to contain the disease if an outbreak occurs. Nevertheless, DHS
officials told us that this does not obviate the need to plan for such an
event. Moreover, past experience has demonstrated that, despite USDA
efforts, quickly controlling a disease has not always been possible. The
exotic Newcastle disease outbreak that originated in California in 2002 is
a case in point: it spread to two neighboring states over the course of a
year despite vigorous USDA and state efforts.^52

50West Nile virus is usually spread by the bite of an infected mosquito. Mosquitoes become
infected when they feed on infected birds. Infected mosquitoes can then spread the virus to
humans and other animals. The presidential declaration of emergency declared for West
Nile virus authorized funding so that local governments could be reimbursed for the cost of
fighting the disease.

51The criteria set out in Homeland Security Presidential Directive 5 are (1) a federal
department or agency acting under its own authority has requested the assistance of the
Secretary of Homeland Security; (2) the resources of state and local authorities are
overwhelmed and federal assistance has been requested by the appropriate state and local
authorities, for example, under the Stafford Act; (3) more than one federal department or
agency has become substantially involved in responding to an incident; or (4) the Secretary
of Homeland Security has been directed by the President to assume responsibility for
managing a domestic incident.

USDA Has Not Identified Response Capabilities for Highly Pathogenic AI

DHS and state officials have expressed concern that USDA's plans for
highly pathogenic AI do not identify the capabilities needed to carry out
the tasks associated with an outbreak scenario--that is, the entities
responsible for carrying out the tasks, the specific resources needed, and
the source of those resources (as described in fig. 5). Although USDA's
draft summary response plan identifies various tasks, such as mass
depopulation, it does not address the capabilities needed to carry out the
tasks under a particular scenario.

Figure 5: Identifying Capabilities Needed for Highly Pathogenic AI

52This highly contagious and fatal poultry disease cost the states and federal government
more than $170 million to eradicate, and it cost an unknown number of bird owners their
livelihoods and, in some cases, their pets.

While we recognize that identifying capabilities is complex because it
involves input from all responding entities and the capabilities required
will change according to the outbreak scenario, it is important to provide
a benchmark for planning purposes, particularly in the face of
uncertainty. Moreover, Homeland Security Presidential Directive 8 calls
for a national preparedness goal that uses capabilities-based planning.
According to DHS, such planning helps determine how prepared we are as a
nation, how prepared we need to be, and how to prioritize efforts to
effectively respond to an emergency.^53

In response to this directive, USDA has, with assistance from other
federal agencies and entities, begun identifying capabilities in advance
for an outbreak of foot-and-mouth disease. Although some of the
capabilities associated with foot-and-mouth disease could translate to
responding to an outbreak of highly pathogenic AI, there are differences
between addressing disease outbreaks in livestock and in poultry. In
addition, unlike foot-and-mouth disease, highly pathogenic AI can infect
humans, so capabilities must be identified in advance for protecting human
health. USDA has also started planning for various scenarios with its
draft interagency playbook. However, this playbook does not identify the
capabilities for the various tasks, and it excludes key players, including
state and industry officials. Moreover, USDA officials told us that the
playbook was never intended to be shared with states.

According to DHS officials, once capabilities are identified, they should
be incorporated into a response plan that can be used to track progress.
Such a plan--known as a concept of operation plan--is central to emergency
management. The plan should list the critical tasks for responding to the
selected outbreak scenario and, for each task, the responsible entities
and the location of resources needed. In addition, the plan should specify
time frames and completion status for each critical task. DHS officials
told us that a plan of this nature is essential to identify gaps in
capabilities. As we reported in 2006,^54 emergency preparedness and
response should be characterized by measurable goals and effective efforts
to identify key gaps between those goals and current capabilities, with a
clear plan for closing those gaps. However, a plan alone is not sufficient
to ensure effective response. Conducting exercises is critical for
developing skills and identifying what works well and what needs further
improvement.

53On December 17, 2003, the President issued Homeland Security Presidential Directive 8 to
establish policies to strengthen the preparedness of the United States to prevent and
respond to threatened or actual domestic terrorist attacks, major disasters, and other
emergencies by requiring national domestic all-hazards preparedness ï¿½Goal.ï¿½ The Goal
utilizes a capabilities-based planning approach.

54GAO, Emergency Preparedness and Response: Some Issues and Challenges Associated
with Major Emergency Incidents, GAO-06-467T (Washington D.C.: Feb. 23, 2006).

Incomplete State Plans Could Slow Response

USDA officials told us, and our own review corroborated, that some state
plans for addressing outbreaks of highly pathogenic AI are lacking
important components that could facilitate rapid containment of the virus
(see table 2). Our review of 19 state plans^55 found that 5 plans at least
partially addressed all of the AI planning components that we identified
as important in managing an AI outbreak. However, 14 plans did not address
one or more critical planning components. The states reviewed account for
51 percent of total U.S. poultry production and 7 of the top 10 poultry
producing states.^56

Table 2: Gaps Identified in State Plans

                                        

        Planning component           Number of plans we reviewed that did not 
                                                            address component 
Incident Command System                                            7 of 19 
Time frames                                                        4 of 19 
Depopulation                                                       4 of 19 
Disposal                                                           2 of 19 
Response among backyard birds                                      3 of 19 
Biosecurity                                                        1 of 19 
Public communications                                              4 of 19 
Public health                                                      5 of 19 

Source: GAO.

55USDA officials responsible for helping states develop response plans provided us with 19
plans, which the states made available to them during the course of our review.

56These numbers are based on USDAï¿½s 2002 Census of Agriculture.

The following discussion details some of the gaps we identified:

oIncident Command System. The Incident Command System is critical to
ensure that responses to any type of incident are effectively managed, yet
7 of the 19 state plans we reviewed--including 3 of the top 10 poultry
producing states--had no discussions about incident command or its
importance in AI response. Moreover, all levels of government are required
to adopt the Incident Command System into their response plans.

oTime frames. To help contain an outbreak, USDA recommends several
critical actions for the affected state in the early stages of response,
such as initiating laboratory confirmation procedures and issuing
quarantine notices; however, 4 of the 19 plans had no discussions about
initial critical actions. Incident Command System training documents^57
and USDA's highly pathogenic AI response plan,^58 respectively, recommend
establishing immediate response priorities and creating a detailed plan
for the first 24 hours of response to an incident.

oDepopulation. Four of the 19 plans did not address depopulation.
Depopulating birds is the fundamental strategy USDA and states employ for
controlling outbreaks, as identified in USDA's highly pathogenic AI
response plan.

oDisposal. Two of the 19 plans did not address the disposal of AI infected
poultry and materials. USDA's highly pathogenic AI response plan states
that effective disposal is a key component of highly pathogenic AI
response and includes issues such as disposal options and the biosecure
transportation of infected materials.

oResponse among backyard birds. Three of the 19 plans did not include a
discussion about response activities for backyard birds. USDA officials
told us that the development of some state plans was heavily influenced by
the poultry industry, which may be the reason this response component was
omitted. This is troublesome because an outbreak must be contained among
backyard birds, as well as in commercial operations. In addition, a recent
USDA survey estimates that about 40 percent of backyard birds are located
within 1 mile of at least four commercial poultry facilities.^59 This
close proximity could allow the virus, if not quickly contained, to spread
from backyard birds to commercial operations--as has occurred in previous
poultry disease outbreaks.

57ï¿½Incident Command System Review Materialsï¿½ from the Federal Emergency Management
Agencyï¿½s ICS Resource Center Contents Web site,
http://training.fema.gov/EMIWeb/IS/ICSResource/index.htm.

58The response plan we refer to is APHISï¿½ National Highly Pathogenic Avian Influenza
Response Plan.

oBiosecurity. We found that one state plan had no discussion about
biosecurity. USDA recommends implementing biosecurity measures to keep
flocks free from disease during an outbreak.^60 In addition, our site
visits to commercial and backyard facilities found varying levels of
biosecurity--from very stringent to very lax. Further, a recent USDA
survey found that backyard bird owners do not always implement basic
biosecurity measures. For example, 89 percent do not require visitors to
wash their hands before handling birds, and only 40 percent require hand
washing after handling birds.

oPublic communications. Four of 19 state plans did not address public
communications. Federal and state officials told us that clear public
communications are essential during an outbreak to manage the media, avoid
public confusion, and disseminate a clear public health message. In
addition, the required Incident Command System calls for a Joint
Information Center and a Public Information Officer (who is responsible
for media outreach) to ensure clear and accurate public information, none
of which were mentioned in these four plans.

oPublic health. Five of the 19 plans did not address the role of local,
state, or federal public health authorities during an outbreak. USDA's
draft summary plan recommends that public health authorities initiate
appropriate health measures (e.g., identify those potentially exposed and
in need of antiviral medication) and help ensure accurate public
communications.

USDA and state officials told us there are several reasons why planning at
the state level is not more complete. First, although USDA officials
review state response plans, the agency does not have the authority to do
more than offer comments and recommendations. It is up to the state to
make any changes that USDA recommends. Second, USDA and state officials
told us that there are no established federal criteria for what a state
response plan for highly pathogenic AI should include, which has made
developing and assessing the plans more difficult. In the absence of such
criteria, USDA and state officials we interviewed told us they are relying
on experience from past outbreaks or applying criteria from other
programs. Third, state officials said that state emergency planning
resources are limited. Despite recognizing the need for such planning,
officials said they do not have the resources and staff to devote to such
a planning effort. Similarly, these same officials told us that because
APHIS officials who assist in planning cover several states
simultaneously, their resources are also spread too thin to meet each
state's AI planning needs. State officials told us that because of these
resource limitations and other considerations, some states have formed
cooperatives in order to pool limited planning resources and work together
regionally to integrate AI and other foreign animal disease emergency
planning.

59Poultry ï¿½04 Part I: Reference of Health and Management of Backyard/Small Production
Flocks in the United States, 2004; USDA, August 2005.

60For specifics, see USDAï¿½s National Animal Health Emergency Management System.

Unresolved Issues Could Delay Response

We have identified several unresolved issues that, if not addressed, could
hinder response efforts. Moreover, some could pose a particular challenge
for states that have never encountered an outbreak. These unresolved
issues are as follows:

oThe location and number of backyard birds. According to USDA, state, and
industry officials from all five states that we visited, containing an
outbreak among backyard birds remains a challenge because their numbers
and location are still unknown. For example, a 2002 outbreak of exotic
Newcastle disease in California took almost a year to contain because the
disease spread as responders spent valuable time trying to locate
potentially infected birds in urban areas. State and USDA officials told
us they were surprised by and unprepared for the large number of backyard
birds that existed in such areas. This difficulty was exacerbated by the
heavy automobile traffic, slowing responders' ability to reach each
potential bird owner's home. Further complicating matters, many of these
birds were expensive game fowl bred for illegal cockfighting and, as a
result, owners sometimes moved the birds into hiding to avoid authorities
and prevent the birds from being depopulated. This contributed to the
spread of the disease.

While the numbers and locations of backyard birds within the state may
never be definitively known, state officials told us there are steps that
can be taken to help mitigate this problem. California formed a group of
state and USDA officials whose goal is to minimize the risk of disease
spread through local outreach and education. In addition, the group
performs regular testing and voluntary surveillance of backyard premises,
live bird markets, feed stores, pet stores, auction yards, and swap meets.

Other states that have experienced outbreaks are similarly concerned
because when an outbreak occurs, typical response involves conducting an
epidemiological investigation--a careful tracking of all animals, people,
and equipment that are within a certain distance of the infected premises.
Because it is not known where backyard bird owners are located,
epidemiological teams must go door-to-door to survey surrounding
residences. To help overcome this tracking problem, Delaware and
Maryland--both with dense commercial poultry operations--have introduced
mandatory registration for all poultry owners, including those with
backyard flocks. Further, some state officials, such as those in Texas,
are working with USDA to do extensive outreach to game fowl owners. A
recent USDA survey shows that game fowl represent the third largest
population of birds raised in backyard environments. Texas officials told
us that game fowl are particularly prevalent in the state because of its
proximity to Mexico, Louisiana, and New Mexico. Cockfighting is legal in
Louisiana and had been legal in New Mexico until March of 2007.
Consequently, state officials are trying to locate these bird owners to
brief them about the importance of reporting birds that die or appear
diseased with highly pathogenic AI. Officials have also briefed these
owners on the risks highly pathogenic AI poses to game fowl handlers.^61

oDiagnostic laboratory response. Officials from all five states we visited
cautioned that diagnostic laboratory capacity could be quickly overwhelmed
during an outbreak. In particular, the large number of samples that would
need to be tested and the limited number of laboratory personnel available
remain problematic. These tests are necessary to identify the extent of
the disease spread, as well as to track the success of eradication efforts
and prove to trading partners that poultry products are safe for export.
Laboratory officials told us that within days of an outbreak--sometimes
even hours--their diagnostic laboratories were running at capacity, with
exhausted employees working overtime, usually for several months, to meet
the testing needs during the outbreak. To accommodate the increased volume
of samples, laboratory officials in two states told us they relied on
support from USDA's National Veterinary Services Laboratories or
neighboring laboratories. However, these same laboratory officials told us
that while USDA was very generous with its support, they are concerned
that the agency may not be able to provide such support in the event of
multiple outbreaks. Officials in another state overcame this problem by
accepting volunteers from various agencies to run samples but noted that,
because these volunteers were unskilled in laboratory procedures, valuable
time was lost in training them.

61State officials familiar with cockfighting told us that handlers resuscitate down birds in the
middle of a fight by using their mouth to clear congestion in the beak. According to the
Occupational Safety and Health Administration, exposure of the conjunctival membranes of
the eyes and/or nasal mucosa to secretions from AI infected birds is the predominant route
of transmission of these viruses to humans.

Another problem encountered during past outbreaks was transporting samples
to the laboratory in a timely manner, especially in large states. For
example, in one state, the laboratory running the diagnostic AI tests was
located 3 hours from the site of the outbreak. Laboratory officials told
us it was resource-intensive for personnel to drive 3 hours each way to
collect samples. Moreover, because samples were collected and delivered to
the laboratory at the end of the day, a bottleneck developed, requiring
laboratory technicians to work overtime to complete tests. The laboratory
has since put in place a "pony express" system, in which samples will be
delivered to and collected from a drop-off point midway between the
infected premises and the laboratory. Laboratory officials in California
that dealt with these challenges throughout the yearlong exotic Newcastle
disease outbreak advocate developing an advance emergency response plan
specifically for diagnostic laboratory operations that covers, for
example, rotating work schedules for laboratory workers, protocols for
receiving samples, and an Incident Command System specific to a laboratory
setting to facilitate emergency response.

oDepopulation. Mass depopulation of infected birds is a continuing
challenge because of the number of workers needed to depopulate a
commercial poultry house, the time required to do so, and the risk to
human health as a result of workers' direct exposure to the virus. State
and industry officials estimate that it takes 20 to 30 workers to
depopulate a single commercial broiler house using a common method of mass
depopulation, carbon dioxide gas. Because of the large number of birds
involved--tens of thousands in a commercial broiler house--this process
can take several hours. This method, therefore, puts workers' health at
risk by exposing them for prolonged periods of time to potentially high
concentrations of the virus within a confined space.

Recently, USDA conditionally approved the use of a new water-based foam
method for mass depopulation that requires only two or three workers to
administer, thereby minimizing the number of workers exposed to the virus.
Despite the availability of this new method, there are still two issues of
concern related to its use. First, USDA's approval of this method is
conditional. For example, it cannot be used to depopulate many types of
poultry, such as ducks, geese, and quail, because the necessary testing to
prove that the birds are not suffering during the depopulation process has
yet to be conducted. USDA officials told us that they have begun working
with the University of Delaware and the North Carolina Department of
Agriculture and Consumer Services to investigate the effects of using foam
to depopulate these populations. Second, this method cannot be applied in
all environments, such as in houses where birds are raised in cages, which
is the most challenging commercial environment to depopulate. USDA, state,
and industry officials told us that depopulating layers raised in cages is
a particularly time-consuming process because a commercial layer house can
contain hundreds of thousands of birds, and each bird must be removed from
its cage before it can be killed.

oDisposal. State officials told us that disposal remains a problem for
three reasons. First, although there are several disposal options--such as
burial on-site or in a landfill, and incineration (see fig. 6)--the
feasibility of each option is largely dependent on environmental
conditions within that state. For example, officials in one state told us
that while burial is allowed under state law, the existence of shallow
bedrock in some parts of the state renders that option physically
impossible.

Figure 6: Methods of Poultry Disposal

Second, disposal requires coordination among various state agencies,
including animal health, environment, and transportation to identify
acceptable locations and methods. For example, during one state outbreak,
response stood still for several weeks while the state animal health
agency negotiated with the state environmental quality agency on
permissible disposal sites. Animal health officials in the state told us
that they had customarily used on-site burial for disposal, but that
during the outbreak, the environmental agency prohibited that option
because residents worried about water contamination. For nearly a month,
the animal health agency worked to identify major municipal landfills that
would accept the birds and establish protocols for transporting the
carcasses there. During this time, they could not dispose of any birds,
and 40 more flocks became infected, overwhelming state and industry
resources.

Third, given the heightened public awareness and concerns about highly
pathogenic H5N1, disposal options may be limited. Officials in one state
told us that landfill owners who once accepted AI-infected poultry and
material are now refusing to accept poultry carcasses infected with either
low pathogenic or highly pathogenic AI because of public fears about the
human health risks.^62 Officials in another state are beginning to
experience the same problem. State and USDA officials told us that on-site
composting is a preferred method because it kills the virus without moving
the infected material off the infected premises. But this option is not
always available because, for example, some poultry houses are too small
to accommodate the equipment needed to compost. State and industry
officials also told us that ensuring the infected materials are completely
composted requires careful attention and maintenance. Failure to dispose
of infected carcasses in a timely manner increases the risk of disease
spread and allows the virus to remain in the environment.

62State officials told us that the general public does not understand the difference between
low and highly pathogenic AI.

oMovement of birds through the mail. DHS and some state officials remain
concerned that birds shipped through the mail or on commercial airlines do
not all have health certificates to ensure they are free from disease. As
a result, birds infected with highly pathogenic AI could be delivered to
unsuspecting owners, causing the disease to spread long distances to once
healthy flocks. For example, poultry are often moved through the U.S.
Postal Service for distribution and breeding purposes. Most states require
that birds brought into the state be health-certified via USDA's National
Poultry Improvement Plan^63 or accompanied by a veterinary health
certificate issued in the state of origin. However, concerned state
officials told us that the U.S. Postal Service does not always check for
the state-required documentation, and they are concerned that many birds
are entering states undocumented, illegally, and potentially diseased. In
2003, agriculture officials in North Carolina tracked shipments of birds
at three postal facilities for 9 days. Of the 5,113 birds entering the
state via the U.S. Postal Service, 72 percent, or 3,127 birds did not have
the necessary health documentation certifying they were free from disease.
In addition, birds without health certification were collocated in the
same room as birds with health clearances, possibly spreading disease from
infected to certified healthy birds.

DHS and state officials told us that this problem could affect commercial
airlines as well. Birds are transported on commercial aircraft, but,
according to state officials, airlines do not consistently check for
health certification. In light of this concern, state officials in North
Carolina interviewed airline representatives and found that airline
policies for accepting birds varied widely. While some airlines required
health documentation, others did not. These officials told us they do not
know the extent of this problem because they were restricted from entering
airline cargo holding areas.

63States generally require USDAï¿½s National Poultry Improvement Plan certification for
salmonella, pullorum, and typhoid.

oPersonal protective equipment. State and industry officials who have used
personal protective equipment in past outbreaks caution that, although
necessary, equipment to protect workers remains problematic and, under
various conditions, could encumber and delay response. In 2006, the
Department of Labor's Occupational Safety and Health Administration
released updated guidance for protecting poultry workers in the event of a
suspected or confirmed AI outbreak at a poultry facility.  ^64
Specifically, it recommends that animal health responders wear protective
clothing, such as an impermeable apron or surgical gown with long, cuffed
sleeves; disposable protective shoe covers or rubber or polyurethane boots
that can be cleaned and disinfected; safety goggles to protect the mucous
membranes of the eyes; and, at a minimum, disposable, particulate
respirators (e.g., N95). Responders who cannot wear a disposable,
particulate respirator, because of facial hair or other limitations,
should wear a loose-fitting (i.e., helmeted or hooded) powered air
purifying respirator equipped with high-efficiency filters.

State officials told us that in poultry houses that have been sealed to
prevent the virus from spreading, temperatures can become extreme in hot
weather, slowing down responders wearing this type of equipment. In
addition, state officials told us goggles can become fogged, making it
impossible to see. Moreover, the minimum required disposable particulate
respirator is difficult to breathe through, yet it is commonly used
because of its low cost.^65 For these reasons, workers have, at times,
removed the protective equipment while carrying out their duties.^66
Furthermore, officials told us it is difficult and dangerous for
responders to attempt to climb ladders to reach birds in cages several
stories high wearing heavy boots, thick gloves, and hooded respirators.

64The guidance takes into consideration HHSï¿½ Centers for Disease Control and Prevention
Interim Guidance for Protection of Persons Involved in U.S. Avian Influenza Outbreak
Disease Control and Eradication Activities. The recommendations are based on
precautions that are considered best practices for protecting individuals involved in the
response to an AI outbreak.

65The disposable particulate respirator costs about $1 each, depending on the model.

66According to updated guidance from the Occupational Safety and Health Administration
for protecting employees from AI viruses, in the event of an outbreak, a safety and medical
adviser should be identified to ensure compliance with procedures. However, according to
USDA officials, these advisers need not be at the site of the outbreak.

Finally, federal, state, and industry officials told us that respirators
pose other challenges. Specifically, the Occupational Safety and Health
Administration's standards require that respirators be used in the context
of a complete respiratory protection program. This program involves, among
other things, selecting an appropriate respirator, conducting medical
evaluations to determine an employee's ability to use a respirator,
providing training, and checking to ensure that respirators fit properly.
To be effective, tight-fitting respirators must have a proper sealing
surface on the wearer's face. USDA officials told us that, although they
are diligently working to medically evaluate and fit responders with
respirators at this time, it is expected that some of this will still need
to occur at the time of an outbreak, slowing down the response process.
Another concern involves the use of powered air purifying respirators.
Some state officials told us they are expensive and impractical.^67 It
takes many hours to depopulate a house, but the batteries to operate this
kind of respirator last only for specified periods of time, potentially
delaying response.^68 These respirators are also heavy. One state official
told us that, as an alternative, the state department of agriculture is
planning to use a full-face respirator for a variety of reasons. A
full-face respirator is lighter and less expensive^69 than a powered
respirator and, because it does not require batteries, there is no time
limit for use. Also, it has an advantage over goggles because it is less
prone to fogging. According to Occupational Safety and Health
Administration guidelines, all respirators have pros and cons.

oAntiviral medication. USDA has not estimated the amount of antiviral
medication that it would need in the event of an outbreak of highly
pathogenic AI or resolved how to provide such supplies within the first 24
hours of an outbreak. According to Occupational Safety and Health
Administration guidelines, poultry workers responding to an outbreak of
highly pathogenic AI should take antiviral medication daily while working
at the site of an outbreak and each day for 7 days after leaving the site.
Further, the National Veterinary Stockpile is required to contain
sufficient amount of antiviral medication to respond to the most damaging
animal diseases that affect human health and the economy, and it must be
capable of deployment within 24 hours of an outbreak.^70

67Powered air purifying respirators cost about $1,500 each, but price can vary depending on
model and type of batteries used.

68The length of time depends on the battery.

69A full-face respirator costs about $130 each, but the price can vary depending on the
model.

Despite these requirements, stockpile officials have not estimated how
much antiviral medication would be needed during a particular outbreak
scenario. In addition, the National Veterinary Stockpile has not yet
obtained any antiviral medication for highly pathogenic AI. Stockpile
officials cite several reasons for this. First, since the National
Veterinary Stockpile is responsible for many animal diseases, not just
highly pathogenic AI, it faces competing priorities. According to these
officials, the first priority is to build the infrastructure to acquire,
maintain, and deliver veterinary supplies for critical animal diseases,
including highly pathogenic AI. Second, although this infrastructure could
be used to deliver antiviral medication for highly pathogenic AI,
stockpile officials told us that, to prevent duplication of efforts and
limit costs,^71 the best strategy would be to gain access to HHS'
Strategic National Stockpile of 16 million doses of the same antiviral.^72
Presidential Directive 9 emphasizes that the National Veterinary Stockpile
should leverage, where appropriate, the mechanisms and infrastructure that
have been developed for the management, storage, and distribution of the
Strategic National Stockpile. However, HHS officials told National
Veterinary Stockpile officials that the antiviral medication in the
Strategic National Stockpile is reserved for use during a human pandemic
and is not to be used to protect responders to an outbreak of AI among
poultry. Third, as an alternative, National Veterinary Stockpile officials
told us they are in the process of contracting with a manufacturer of
antiviral medication to provide, within 24 hours of an
outbreak, antiviral medication for 3,000 responders for 6 weeks.^73
However, according to stockpile officials, this contract is not yet in
place.

70Homeland Security Presidential Directive 9 ï¿½ 18(a).

71According to DHS and National Veterinary Stockpile officials we interviewed, the stockpile
is underfunded.

72The Strategic National Stockpileï¿½s goal is to have 26 million doses of antiviral medication
on hand by the end of 2006 and a total of 50 million by the end of 2008.

Although the National Veterinary Stockpile does not yet have antiviral
medication on hand, another unit within APHIS--the Safety, Health, and
Employee Wellness Branch--currently has 34,800 doses and has been working
to secure more. In fact, the branch recently entered into an agreement
with HHS' Federal Occupational Health agency to, among other things,
provide medical professionals at the site of an outbreak who would supply
and distribute antiviral medication to responders, as well as monitor
their health.^74 However, the agreement does not specify how many doses
will be provided or when they will be delivered. According to branch
officials, delivery can be guaranteed only if APHIS purchases a set amount
of antiviral medication in advance of an outbreak. Given the current
situation, Federal Occupational Health will supply whatever amount of
antiviral medication it has in stock at the time of an outbreak, which may
or may not be sufficient, and then pursue additional doses. In the
meantime, according to branch officials, the branch will provide
responders the 34,800 doses it currently has on hand. However, this supply
is set to expire at the end of 2007, and the branch has no funds to
replace it. Branch officials told us they are working to extend the shelf
life of the antiviral medication, but this process can take up to 6
months.^75

Conclusions

The rapid spread of highly pathogenic H5N1 has heightened worldwide
awareness of the potential damage AI can inflict on the poultry industry
and the serious implications it has for human health. Considerable effort
is being made by USDA and other federal agencies, the states, and the
poultry industry to ensure a swift and effective response to highly
pathogenic AI. While much has been accomplished already, opportunities
remain to identify and close gaps and to address shortcomings in the
preparations that have been made thus far.

73National Veterinary Stockpile officials told us that this number reflects, in part, the total
number of individuals involved during the height of the exotic Newcastle disease outbreak
in California in 2002. It does not reflect a calculated estimate of those exposed to the virus
and in need of antiviral medication.

74Branch officials told us they selected Federal Occupational Health for this purpose
because it has frequently worked with DHSï¿½ Federal Emergency Management Agency to
ensure worker protection during emergencies.

75Branch officials told us that the process they are using is similar to HHSï¿½ process called the
Shelf Life Extension Program.

First, unless USDA and DHS work diligently together to ensure roles and
responsibilities are clearly defined, effectively communicated, and well
understood in advance of a significant outbreak, delay could occur at the
federal level as the two agencies attempt to work out their relationship
during a time of crisis. Second, unless USDA identifies capabilities for a
defined outbreak scenario, creates a response plan based on this
information with the appropriate performance measures, and then tests this
plan, USDA and its response partners will not be well-informed on their
level of readiness. Third, until USDA develops a standard set of criteria
that state response plans should contain, state-level plans will continue
to have shortcomings that could impede efforts to contain future
outbreaks. Fourth, unless USDA provides additional assistance to states to
address unresolved issues, USDA and the states will face real-time
challenges as an outbreak unfolds; a potentially devastating scenario.
Similarly, until USDA resolves uncertainties regarding antiviral
medication, the health risks associated with highly pathogenic AI may
prevent or delay responders from carrying out their duties within a
critical and limited window of opportunity.

Recommendations for Executive Action

To address challenges that limit the nation's ability to quickly and
effectively respond to highly pathogenic AI, we recommend that the
Secretaries of Agriculture and Homeland Security develop a memorandum of
understanding that describes how USDA and DHS will work together in the
event of a declared presidential emergency or major disaster, or an
Incident of National Significance, and test the effectiveness of this
coordination during exercises.

In addition, we recommend that the Secretary of Agriculture take the
following seven actions:

oIn consultation with other federal agencies, states, and the poultry
industry, (1) identify the capabilities necessary to respond to a probable
scenario(s) for an outbreak of highly pathogenic AI; (2) use this
information to develop a response plan that identifies the critical tasks
for responding to the selected outbreak scenario and, for each task,
identifies the responsible entities, the location of resources needed,
time frames, and completion status; and (3) test these capabilities in
ongoing exercises to identify gaps and ways to overcome those gaps.

oDevelop standard criteria for the components of state response plans for
highly pathogenic AI, enabling states to develop more complete plans and
enabling USDA officials to more effectively review them.

oFocus additional work with states on how to overcome potential problems
associated with unresolved issues, such as the difficulty in locating
backyard birds and disposing of carcasses and materials.

oDetermine (1) the amount of antiviral medication that USDA would need in
order to protect animal health responders, given various highly pathogenic
AI scenarios, and (2) how to obtain and provide supplies within 24 hours
of an outbreak.

Agency Comments and Our Evaluation

We provided a draft of this report to USDA and DHS for their review and
comment. Also, both departments provided technical comments that we
incorporated as appropriate.

USDA agreed with all but one of our recommendations. USDA stated that it
does not believe a memorandum of understanding is the best vehicle for
clarifying and defining the roles of DHS and USDA in the event of a
declared presidential emergency or major disaster, or an Incident of
National Significance. Nevertheless, USDA accepted the need to clarify
roles during such an event and further supported the need to test this
coordination in formal exercises. USDA also stated that it will work with
DHS, states, and other agencies to identify the best interagency mechanism
to accomplish this planning. GAO believes that written clarification is
important and that a memorandum of understanding is an appropriate
mechanism to accomplish this goal. In fact, the National Response Plan
anticipates the use of such documents to further clarify agency roles.

USDA also stated that the report is a comprehensive look at USDA's efforts
to prepare for highly pathogenic AI. However, the department noted that
the report does not highlight several critical components of successful
foreign animal disease planning, such as USDA's robust veterinary
infrastructure and the National Animal Health Laboratory Network. GAO
recognizes that USDA has important preparations in place to respond to
foreign animal diseases in general that are also relevant for AI. However,
it is not possible to include all planning measures. Our report focuses on
USDA preparations for highly pathogenic AI specifically. USDA's written
comments and our evaluation appear in appendix II.

DHS agreed that further coordination between USDA and DHS is needed in the
event of a declared presidential emergency or major disaster, or an
Incident of National Significance. In addition, the department supported
the need to test the effectiveness of this coordination through exercises.
DHS also suggested that coordination could occur through an interagency
concept of operation plan. DHS' written comments appear in appendix III.

As we agreed with your offices, unless you publicly announce the contents
of this report earlier, we plan no further distribution of it until 15
days from the date of this report. At that time, we will send copies of
this report to the appropriate congressional committees, the Secretaries
of Agriculture and Homeland Security, and other interested parties. We
will also make copies available upon request. In addition, the report will
be available at no charge on the GAO Web site at http://www.gao.gov .

If you or your staff has any comments or questions about this report,
please contact me at (202) 512-3841 or [email protected] . Contact
points for our Offices of Congressional Relations and Public Affairs may
be found on the last page of this report. GAO staff who made key
contributions to this report are listed in appendix IV.

Daniel Bertoni
Director, Natural Resources and Environment

List of Committees

The Honorable Tom Harkin
Chairman
The Honorable Saxby Chambliss
Ranking Member
Committee on Agriculture, Nutrition and Forestry
United States Senate

The Honorable Joseph Lieberman
Chairman
The Honorable Susan M. Collins
Ranking Member
Committee on Homeland Security and Government Affairs
United States Senate

The Honorable Edward M. Kennedy
Chairman
Committee on Health, Education, Labor, and Pensions
United States Senate

The Honorable Arlen Specter
Ranking Member
Subcommittee on Labor, Health and Human Services, Education,
and Related Agencies
Committee on Appropriations
United States Senate

The Honorable Daniel K. Akaka
Chairman
Subcommittee on Oversight of Government Management, the Federal
Workforce, and the District of Columbia
Committee on Homeland Security and Governmental Affairs
United States Senate

The Honorable Richard Burr
Ranking Member
Subcommittee on Retirement and Aging
Committee on Health, Education, Labor and Pensions
United States Senate

Appendix I:  Scope and Methodology

To describe the steps that the Department of Agriculture (USDA) has taken
to prepare for outbreaks of highly pathogenic avian influenza (AI) in
domestic poultry, we reviewed statutes, regulations, directives, and
national planning documents that broadly define USDA's role in an animal
health or other national emergency. Specifically, we reviewed the Animal
Health Protection Act; the Stafford Act; regulations for indemnification
applicable to highly pathogenic AI, Part 53 of Title 9 of the Code of
Federal Regulations, and those for low pathogenic AI, Part 56 of Title 9
of the Code of Federal Regulations; Homeland Security Presidential
Directives 5, 8, and 9, which respectively address management of domestic
incidents, national preparedness, and the defense of agriculture and food;
the National Response Plan with revisions issued in May 2006; and recently
developed presidential documents, including the National Strategy for
Pandemic Influenza and the Implementation Plan for the National Strategy
for Pandemic Influenza. We also reviewed USDA's National Poultry
Improvement Plan, documents in the National Animal Health Emergency
Management System, as well as those being drafted for highly pathogenic AI
specifically. Furthermore, we interviewed USDA officials from the Animal
Plant Health Inspection Service (APHIS), the Agricultural Research
Service, the Food Safety and Inspection Service, as well as officials from
the offices of the Executive Secretariat, Communications, Budget and
Program Analysis, and General Counsel. We also interviewed Department of
Homeland Security (DHS) officials from the Office of the Chief Medical
Officer, the Federal Emergency Management Agency, and the Preparedness
Directorate. Moreover, we interviewed officials from the National
Association of State Departments of Agriculture, the American Veterinary
Medical Association, the National Turkey Foundation, the National Chicken
Council, the U.S. Poultry and Egg Association, and the Food and Water
Watch. We also attended a Highly Pathogenic Avian Influenza Workshop that
was jointly sponsored by the U.S. Poultry and Egg Association and USDA,
with attendees from academia, the poultry industry, state governments, and
the federal government. Finally, we attended a 3-day AI tabletop exercise
involving representatives from USDA, industry, and the state of Georgia.

To identify any challenges that could affect USDA's ability to protect
domestic poultry from highly pathogenic AI, in addition to the activities
described above for objective one, we conducted structured interviews in
person and via telephone with officials from five states that have
experienced and responded to an outbreak of AI or a comparable highly
infectious avian disease in the past 5 years. These states also represent
varying poultry demographics. Specifically, we interviewed state animal
health and APHIS officials; poultry industry representatives; and animal
health diagnostic laboratory personnel in California, Delaware, Maryland,
Texas, and Virginia. We also visited several commercial and one backyard
poultry operation, as well as live bird markets that kept animals indoors
in cages, as well as those markets with animals housed in outdoor pens. We
also interviewed avian health specialists whom we selected for their
technical expertise on avian health and emergency avian disease response.
In particular, we sought to obtain their comments on the virology and
epidemiology of highly pathogenic AI, including H5N1, as well as current
research in mass poultry depopulation and disposal methods.

To better understand challenges associated with planning at the state
level, we interviewed the officials noted above as well as, at the
recommendation of DHS, officials from the North Carolina Department of
Agriculture and Consumer Services and officials representing 21 states
from the Multi-State Partnership for Security in Agriculture and the
Southern Agriculture and Animal Disaster Response Alliance. We also
conducted structured interviews with APHIS' Regional Directors and Area
Emergency Coordinators who are responsible for working directly with the
states. Among other things, we asked the Area Emergency Coordinators, who
are specifically charged with helping states develop AI response plans, to
identify strengths and weaknesses in their state plans and to characterize
their state's level of readiness for an outbreak.^1 We also performed our
own review and assessment of 19 state plans to corroborate identified
strengths and weaknesses from the interviews. Although we requested that
USDA's coordinators provide us with AI plans from the 44 states with which
they work, they provided us with the 19 plans they had available.

Finally, within GAO, we coordinated our review with GAO teams examining
the role of federal agencies involved in pandemic influenza preparedness,
including DHS, the Department of Health and Human Services, the Department
of State, and the Department of Defense.

We conducted our review from May 2006 to June 2007 in accordance with
generally accepted government auditing standards.

1At the time of our review, there were 16 Area Emergency Coordinators representing 44
states.

Appendix II:  Comments from the Department of Agriculture

The following are GAO's comments on the Department of Agriculture's letter
dated May 21, 2007.

GAO Comments

1.USDA commented that our report does not take into account several
critical components of successful foreign animal disease planning efforts.
GAO recognizes that USDA has important preparations in place to respond to
foreign animal diseases in general that are also relevant for AI. For
example, USDA calls attention to its veterinary infrastructure and its
National Animal Health Laboratory Network. We agree that these are
important for responding to multiple types of disease outbreaks. However,
it is not possible to include all planning measures. The focus of our
report is on steps USDA has taken to prepare for highly pathogenic AI
specifically.

2.We modified our report to include a statement about the importance of
veterinary infrastructure to AI surveillance.

3.The National Response Plan anticipates the use of interagency
agreements, such as memorandums of understanding, to further clarify
agency roles. The intent of the recommendation is to further formalize how
the two departments will coordinate during such an event.

4.We modified our report to include a statement about USDA's National
Animal Health Laboratory Network.

5.During the course of our work, USDA officials specifically requested
that we refer to these reports as "drafts." In addition, the summary AI
response plan is published on USDA's Web site as a draft document.
Nevertheless, we modified our report to state that these documents would
be used in the event of an outbreak.

6.Our report acknowledges that USDA has a preliminary estimate regarding
the amount of antiviral medication needed based on the exotic Newcastle
disease outbreak. However, as our report also states, this number does not
reflect a calculated estimate of those exposed to the virus in need of
medication. Furthermore, our report acknowledges that National Veterinary
Stockpile officials are in the process of contracting with a manufacturer
of antiviral medication to provide, within 24 hours of an outbreak,
antiviral medication for 3,000 responders for 6 weeks. However, as our
report also states, this contract to supply antiviral medication is not
yet in place.

Appendix III:  Comments from the Department of Homeland Security

Appendix IV:  GAO Contact and Staff Acknowledgments

GAO Contact

Daniel Bertoni, (202) 512-3841, or [email protected]

Staff Acknowledgments

In addition to the individual named above, Charles Adams, Assistant
Director; Kevin Bray; Nancy Crothers; Mary Denigan-Macauley; Jeff Jensen;
Christopher Lyons; Terry Richardson; and Margaret Vo made key
contributions to this report.

Don Cowan, Joyce Evans, Lynn Musser, Katherine Raheb, Jeremy Sebest,
Daniel Semick, and Cynthia Taylor also made contributions.

(360700)

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www.gao.gov/cgi-bin/getrpt?GAO-07-652 .

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For more information, contact Daniel Bertoni at (202) 512-3841 or
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Highlights of [42]GAO-07-652 , a report to congressional committees

June 2007

AVIAN INFLUENZA

USDA Has Taken Important Steps to Prepare for Outbreaks, but Better
Planning Could Improve Response

A highly pathogenic strain of avian influenza (AI) has spread to nearly 60
countries over the past few years, killing millions of birds and more than
170 humans. Controlling the virus in poultry is key to reducing the risk
of a human pandemic. The Department of Agriculture (USDA) is responsible
for planning for AI outbreaks in poultry, with states' assistance. The
Department of Homeland Security (DHS) is responsible for coordinating the
federal response for certain emergencies and developing policy documents
that serve as a basis for national emergency planning. GAO described the
steps USDA is taking to prepare for highly pathogenic AI and identified
key challenges. GAO reviewed response plans, statutes, and regulations;
visited poultry operations; interviewed federal, state, and industry
officials in five states that experienced outbreaks; and reviewed 19 state
plans.

[43]What GAO Recommends

GAO recommends that USDA and DHS develop a memorandum of understanding to
clarify their roles during certain emergencies, and USDA should take
several steps to improve its planning and that of the states. USDA agreed
with all recommendations except for the use of a memorandum of
understanding to clarify roles. DHS agreed further clarification of roles
is needed.

USDA is taking important steps to prepare for highly pathogenic AI. For
example, the department has established mechanisms to prevent infected
poultry (see photo) and products from being imported and has developed
several surveillance programs to detect AI. In addition, USDA is
developing response plans specific to highly pathogenic AI and has begun
conducting exercises to test these plans. Moreover, USDA is building a
National Veterinary Stockpile to maintain critical supplies, including
equipment to protect responders. Finally, USDA has launched various AI
research projects, including one to explore why the virus causes disease
and death in some domestic poultry and wild birds but not in others.

While USDA has made important strides, incomplete planning at the federal
and state levels, as well as several unresolved issues, could slow
response. First, USDA is not planning for the lead coordinating role that
DHS would assume if an outbreak among poultry occurred that is sufficient
in scope to warrant various federal disaster declarations. GAO's prior
work has shown that roles and responsibilities must be clearly defined and
understood to facilitate rapid and effective decision making. Moreover,
USDA response plans do not identify the capabilities needed to carry out
the critical tasks associated with an outbreak scenario--that is, the
entities responsible for carrying them out, the resources needed, and the
provider of those resources. Furthermore, some state plans lack important
components that could facilitate rapid AI containment, which is
problematic because states typically lead initial response efforts.
Finally, there are several unresolved issues that, absent advance
consideration, could hinder response. For example, controlling an outbreak
among birds raised in backyards, such as for hobby, remains particularly
difficult because federal and state officials generally do not know the
numbers and locations of these birds. In addition, USDA has not estimated
the amount of antiviral medication that it would need during an outbreak
or resolved how to provide such supplies in a timely manner. According to
federal guidance, poultry workers responding to an outbreak of highly
pathogenic AI should take antiviral medication to protect them from
infection.

A Chicken Infected with Avian Influenza

References

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