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. 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. 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. 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. In 2003, Connecticut had an outbreak of low pathogenic AI that affected more than 3 million commercial laying hens. 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. 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. 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. 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. 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. 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. 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, 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. 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 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.” 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 whose purpose was to form the basis for identifying the capabilities needed to respond to a wide range of emergency events. 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, 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. 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. 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. 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. 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. 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, 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, 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, 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. 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. APHIS is currently drafting response plans for highly pathogenic AI. 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. In addition, USDA is working with the White House Homeland Security Council and other key federal agencies to produce an “interagency playbook” 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, 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. USDA has begun conducting preliminary tabletop exercises 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, the National Association of State Departments of Agriculture, and the Association of State and Territorial Health Officials; representatives of consumer groups and industry officials; and representatives from the Canadian Food Inspection Agency. 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. 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. 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. The stockpile currently owns material sufficient to produce 140 million doses of H5 and H7 AI vaccine to protect older birds. 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.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. 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.Under the new indemnity regulations for H5/H7 low pathogenic AI, large commercial poultry facilities must participate in USDA’s National Poultry Improvement Plan’s AI surveillance program, through a cooperating state agency, in order to be eligible to receive 100 percent indemnity for destroyed birds. Large commercial facilities that do not participate in the surveillance program may receive only 25 percent indemnity. 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. 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. 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. USDA’s Office of Communications has developed risk communication messages about highly pathogenic AI. 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. USDA is concentrating its AI research efforts on areas it considers critical to prepare for outbreaks of highly pathogenic AI. 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 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. 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. 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. 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 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. 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, 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. 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. Select likely cenrio for highly pthogenic AI, highlighting the cope, mgnitde, nd complexity of the orek. Identify lit of criticas for preventing, protecting, reponding to, nd recovering from the cenrio orek. Identify the rerce necessary to crry othe criticl tas nd who i reponle for developing nd mintining thee rerce. 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. 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, 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. 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 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. The following discussion details some of the gaps we identified: Incident 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. Time 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 and USDA’s highly pathogenic AI response plan, respectively, recommend establishing immediate response priorities and creating a detailed plan for the first 24 hours of response to an incident. Depopulation. 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. Disposal. 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. Response 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. 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. Biosecurity. 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. 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. Public 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. Public 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. 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: The 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. To prevent possle orek of highly pthogenic AI, USDA recommend tht poltry prodcer nd deler usioecrity precaution t live ird mrket. Live ird mrket operte in mny mjor citie. AI ce introdced into thee mrket if they receive infected ird or contminted crte nd trck. Once the virusablihed in the mrket, the movement of ird, crte, or trck from contminted mrket cpred the virus to other frm nd mrket. Therefore, USDA recommend the following protective measure hold e tken t live ird mrket to prevent the possle pred of diase: Ue plastic inted of wooden crte for easier clening. Keep le nd floor clen of mre, fether, nd other deri. Clend diinfect ll equipment, crte, nd vehicle efore retrning them to the frm. Keep incoming poltry epte from old ird, epecilly if ird re from different lot. Clend diinfect the mrketplce fter every dy of sale. Do not retrn old ird to the frm. 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. Diagnostic 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. 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. Depopulation. 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. Disposal. 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. 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. 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. Movement 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 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. Personal 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. 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. For these reasons, workers have, at times, removed the protective equipment while carrying out their duties. 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. 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. 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. 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 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. Antiviral 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. 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, the best strategy would be to gain access to HHS’ Strategic National Stockpile of 16 million doses of the same antiviral. 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. However, according to stockpile officials, this contract is not yet in place. 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. 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. 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. 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. 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: In 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. Develop 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. Focus 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. Determine (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. 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 bertonid@gao.gov. 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. 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. 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. The following are GAO’s comments on the Department of Agriculture’s letter dated May 21, 2007. 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. 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.

Summary: 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. USDA is taking important steps to prepare for highly pathogenic AI. For example, the department has established mechanisms to prevent infected poultry 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.