Avian Influenza: USDA Has Taken Important Steps to Prepare for Outbreaks, but Better Planning Could Improve Response
Published: 2007-06-11T00:00:00

Fast Facts:

Highlights:
section_title: Why GAO Did This Study
paragraphs: 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.
section_title: What GAO Found
paragraphs: 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.

section_title: Letter
paragraphs: 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. 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 or major disaster or for the Secretary of Homeland  Security to declare an Incident of National Significance, 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.
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.
USDA provides compensation to owners—indemnifies them—for losses  incurred when USDA depopulates 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.
subsections: section_title: Background
paragraphs: 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.
section_title: USDA Is Implementing Important Measures to Help the Nation Prepare for Outbreaks of Highly Pathogenic Avian Influenza
paragraphs: 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.
subsections: section_title: Import and Smuggling Control
paragraphs: 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.
section_title: Surveillance
paragraphs: 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.
section_title: Response Plans
paragraphs: 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.
section_title: Exercising Response Plans
paragraphs: 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.
section_title: National Veterinary Stockpile
paragraphs: 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.
section_title: Indemnification
paragraphs: 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.
section_title: Communications
paragraphs: 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.
section_title: Research
paragraphs: 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.
section_title: Federal and State Response Plans Are Incomplete, and Several Issues Are Unresolved
paragraphs: 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.
subsections: section_title: USDA Has Not Planned for DHS’ Lead Coordination Role
paragraphs: 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.
section_title: USDA Has Not Identified Response Capabilities for Highly Pathogenic AI
paragraphs: 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.
section_title: Incomplete State Plans Could Slow Response
paragraphs: 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.
section_title: Unresolved Issues Could Delay Response
paragraphs: 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.
section_title: Conclusions
paragraphs: 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.
section_title: Recommendations for Executive Action
paragraphs: 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.
section_title: Agency Comments and Our Evaluation
paragraphs: 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.
section_title: Scope and Methodology
paragraphs: 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.
section_title: Comments from the Department of Agriculture
paragraphs: The following are GAO’s comments on the Department of Agriculture’s  letter dated May 21, 2007.
subsections: section_title: GAO Comments
paragraphs: 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.
section_title: Comments from the Department of Homeland Security
section_title: GAO Contact and Staff Acknowledgments
subsections: section_title: GAO Contact
section_title: Staff Acknowledgments
paragraphs: 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.