Foot-and-Mouth Disease: USDA's Efforts to Prepare for a Potential Outbreak Could Be Strengthened

FMD is a highly contagious viral disease that causes painful lesions on the hooves and mouths of some livestock, making it difficult for them to stand or eat, thus greatly reducing meat and milk production. The United States has not had an FMD outbreak since 1929, but FMD is present in much of the world. An FMD outbreak in the United States could have serious economic impacts, in part because trade partners would likely halt all imports of U.S. livestock and livestock products until the disease was eradicated. These imports were valued at more than $19 billion in 2017.

GAO was asked to review USDA's efforts to prepare for an FMD outbreak. This report examines (1) USDA's planned approach for responding to an FMD outbreak; (2) challenges USDA would face in pursuing its response goals; and (3) how USDA identifies, prioritizes, and monitors corrective actions to mitigate the challenges. GAO observed a USDA FMD preparedness exercise; reviewed agency documents and nongeneralizable questionnaire responses from 29 respondents from federal and state government, livestock industries, and universities; and interviewed officials from federal and state governments and representatives of livestock industries and universities.

The U.S. Department of Agriculture's (USDA) planned approach for responding to an outbreak of foot-and-mouth disease (FMD) includes several strategies. These strategies generally rely on killing infected and susceptible animals, vaccinating uninfected animals, or a combination of both approaches. USDA would implement one or more of the strategies, depending on factors such as the outbreak's size and the resources available, according to agency documents.

USDA would likely face significant challenges in pursuing its response goals of detecting, controlling, and containing FMD quickly; eradicating FMD while seeking to stabilize industry and the economy; and facilitating continuity of commerce in uninfected animals. GAO identified challenges in 11 areas—including allocating a limited supply of FMD vaccine—based on its review of USDA documents, responses to GAO's questionnaire, and interviews with agency officials and others with expertise on FMD. According to USDA, the agency may not have a sufficient supply of FMD vaccine to control more than a small outbreak because of limited resources to obtain vaccine. As shown below, the current vaccine supply would be sufficient to protect about 14 percent of Texas's cattle or about 4 percent of Iowa's swine; these states' cattle and swine populations are the nation's largest. The Agriculture Improvement Act of 2018 includes a provision to increase the FMD vaccine supply.

USDA has identified dozens of corrective actions to mitigate the challenges of responding to an FMD outbreak, as called for in USDA procedures, but has not prioritized these corrective actions or monitored their completion, as also called for in its procedures. USDA has identified the corrective actions through exercises simulating FMD outbreaks, surveys, and lessons learned from other foreign animal disease outbreaks. However, USDA has not completed all of the corrective actions, including actions related to vaccination. Agency officials stated that they have not completed such corrective actions because they have been responding to outbreaks of other animal diseases and have limited resources. Without following agency procedures to prioritize and monitor corrective actions, USDA cannot ensure that it is allocating its resources to the most beneficial actions to prepare for a possible FMD outbreak.

GAO is recommending that USDA follow its procedures to prioritize and monitor the completion of corrective actions that the agency has identified for FMD preparedness. USDA agreed with these recommendations, and described actions it will take to implement them.

Foot-and-mouth disease (FMD) is a highly contagious viral disease that  causes painful lesions on the hooves and inside the mouths of some  species of livestock, making it difficult for them to stand or eat, thus  greatly reducing production of meat or milk. The virus affects domestic  and wild cloven-hoofed animals, such as cattle, swine, sheep, goats,  bison, and deer. There are no known cases of FMD in the United States  as of January 2019, but it is present in more than two-thirds of countries  in the world, so it could be introduced here either accidentally or  intentionally as an act of terrorism, according to documents from the U.S.  Department of Agriculture (USDA). An FMD outbreak in the United  States could severely harm the economy, largely because of trade  repercussions from loss of our nation’s “FMD-free” status. If the United  States lost this status, trading partners would likely be unwilling to accept  our exports until the United States is declared FMD-free again. As a  result, USDA expects that in an FMD outbreak, all exports of cattle,  swine, sheep, goats, and uncooked products from these animals would  temporarily stop. Beef exports in 2017 were valued at about $7 billion,  and pork exports were valued at about $6 billion, according to the U.S.  Meat Export Federation. Depending on the extent and duration of an FMD  outbreak, it could have a significant effect on these exports, as well as the  larger agricultural economy.

USDA is responsible for preparing for an outbreak of FMD in the United  States and coordinating a response if an outbreak occurs, in partnership  with the Department of Homeland Security (DHS), individual states, and  industry. USDA’s goals for its FMD response are to (1) detect, control,  and contain FMD as quickly as possible; (2) eradicate FMD using  strategies to stabilize animal agriculture, the food supply, the economy,  and to protect public health; and (3) provide science- and risk-based  approaches and systems to facilitate continuity of commerce in uninfected  animals.

Some countries have addressed FMD outbreaks in the past by killing and  disposing of infected and susceptible animals, otherwise known as  stamping out. However, South Korea and Japan stamped out millions of  swine and cattle in recent FMD outbreaks but still struggled to contain the  virus. U.S. livestock industries operate on a much larger scale than those  in either South Korea or Japan, which could make stamping out an  outbreak here more difficult. Some countries have used vaccination in  conjunction with stamping out to control FMD.

You asked us to review USDA’s efforts to prepare for an FMD outbreak.  This report (1) describes USDA’s planned approach for responding to an  FMD outbreak; (2) identifies what challenges, if any, USDA would face in  pursuing its FMD response goals; and (3) examines how USDA identifies,  prioritizes, and monitors corrective actions to mitigate these challenges.

To describe USDA’s planned approach for responding to an FMD  outbreak, we reviewed relevant legislation and USDA strategy and  guidance documents. We also interviewed USDA officials at the agency’s  headquarters, laboratories, center for epidemiology and animal health,  and center for veterinary biologics. We selected these officials to  interview because of their knowledge about USDA’s planned approach,  their involvement in preparing for an FMD outbreak, and the roles they  would play in responding to such an outbreak.

To identify what challenges, if any, USDA would face in pursuing its FMD  response goals, we first came up with a list of potential challenge areas.  To develop the list of potential challenge areas, we reviewed USDA  documents, reports about FMD outbreaks in other countries, and after- action reports from 41 preparedness exercises in the United States from  2007 to 2018 in which officials practiced responding to simulated FMD  outbreaks and identified emerging challenges. We also interviewed  USDA headquarters staff and field staff in Iowa (the state with the most  livestock); USDA laboratory officials; state animal health officials in  California, Colorado, Iowa, and North Carolina; representatives from four  different livestock industries; and others with expertise in this area. We  selected the individuals to interview based on their knowledge about  challenges that USDA could face in pursuing its FMD response goals,  their central role in preparing for an FMD outbreak, and recommendations  from other interviewees, as well as diversity in geographic location. We  also visited a swine farm and cattle feedlot in Iowa and interviewed the  owners. We selected a swine farm and cattle feedlot to visit because  swine and cattle were the livestock industries with the greatest  populations of animals in the United States in 2016. We identified a list of  11 potential challenge areas, including vaccination.

To confirm the significance of the challenge areas, we sent a  questionnaire with the list of potential challenge areas to four categories  of individuals: federal government officials, state government officials,  livestock industry representatives, and academic researchers. Within the  categories, we selected individuals from relevant units within USDA and  DHS, states with relatively high livestock populations, different livestock  industries (beef cattle, dairy cattle, swine, and sheep), and academic  researchers with relevant expertise. We asked the recipients whether  USDA would face a significant challenge in each of the 11 areas and  whether they knew of other challenge areas we had not listed. We  defined significant to mean a challenge that is sufficiently great or  important enough to be worthy of USDA action. We sent the  questionnaire to 39 recipients and received responses from 29. Since we  used a nonprobability sample, the results are not generalizable to all  government officials, livestock industry representatives, or FMD experts,  but the responses helped confirm the list of 11 challenge areas and  provided illustrative information about each one.

We reviewed challenges related to vaccination for FMD in greater depth  than other challenges because of the significant role vaccination could  play if reliance solely on stamping out is not feasible. Specifically, we  visited DHS’s Plum Island Animal Disease Center on Plum Island, New  York, where we interviewed officials from USDA’s Foreign Animal  Disease Diagnostic Laboratory and others about challenges related to  FMD vaccination. We also reviewed agency documents on the topic and  interviewed other officials from USDA, universities, states, and industry  groups about issues related to FMD vaccination. Further, we interviewed  officials from the vaccine company that currently produces the majority of  FMD vaccine available for use in the United States and a company that  has exclusive rights to use a modified version of the FMD virus to  produce FMD vaccine in the future.

To determine how USDA identifies, prioritizes, and monitors corrective  actions to mitigate the challenges, we reviewed related USDA guidance  and other agency documents, observed an FMD preparedness exercise,  reviewed after-action reports from 41 previous FMD preparedness  exercises, and interviewed USDA officials. The FMD preparedness  exercises were sponsored by USDA, DHS, and state governments, and  ranged from small-scale exercises focused on narrow response tasks to  large-scale exercises in which participants practiced a wide range of  response activities in a simulated outbreak. We reviewed USDA’s  procedures for evaluation and improvement planning to understand how  the agency is to identify, prioritize, and monitor corrective actions. To  determine whether USDA was consistently following these procedures,  we reviewed the 41 after-action reports for FMD preparedness exercises  and interviewed agency officials about corrective actions identified in the  reports and steps the agency has taken to prioritize and monitor progress  on the actions. We reviewed agency documents and interviewed agency  officials about examples of corrective actions that USDA has identified  and taken or not yet taken. We also reviewed USDA after-action reports  for outbreaks of highly pathogenic avian influenza (avian influenza) and  reviewed USDA’s database of related corrective actions to learn how the  agency identified, prioritized, and monitored actions to mitigate  challenges for that disease. To assess the overall reliability of the  database to use information from this database in our report, we reviewed  management controls over the information systems that maintain the  data, and we interviewed USDA officials who manage the database. We  determined that the database was sufficiently reliable to allow us to  describe the contents of the database and general status of corrective  actions. For further details on our objectives, scope, and methodology,  see appendix I.

We conducted this performance audit from May 2017 to March 2019 in  accordance with generally accepted government auditing standards.  Those standards require that we plan and perform the audit to obtain  sufficient, appropriate evidence to provide a reasonable basis for our  findings and conclusions based on our audit objectives. We believe that  the evidence obtained provides a reasonable basis for our findings and  conclusions based on our audit objectives.

This section provides an overview of FMD, as well as information on the  potential impact of an outbreak in the United States; USDA activities to  respond to outbreaks of diseases, including FMD; federal, state, tribal,  and industry roles in FMD control; and FMD vaccines.

FMD is a highly contagious viral disease that causes fever and painful  lesions on cloven-hoofed animals’ hooves, mouths, and udders (see fig.  1). These debilitating effects, rather than high mortality rates, are  responsible for severe productivity losses associated with FMD. The  disease generally does not infect humans and is not considered a public  health or food safety threat. Young animals may die from the virus, while  most adult animals recover. However, livestock infected with FMD have  severely diminished meat and milk production.

FMD virus can be found in all secretions and excretions from infected  animals, including in breath, saliva, milk, urine, feces, and semen, as well  as in the fluid from the lesions. Animals can release the virus for up to 4  days before showing visible signs of infection, and FMD can spread from  one animal species to another. The virus itself can survive in the  environment for many months and can spread when healthy animals  come into contact with infected animals or via contaminated vehicles,  equipment, clothes, feed, or animal products, as shown in figure 2.

The United States has not had an FMD outbreak since 1929, but the  disease could be introduced here from countries in Africa, Asia, Eastern  Europe, or South America where it is present. The United States is  vulnerable to FMD transmission, given the large size and mobility of the  U.S. livestock sector. In 2018, the United States had about 94 million  head of cattle, 74 million swine, 5 million sheep, and more than 2 million  goats. Many of these livestock are concentrated in major livestock- producing states such as Texas and Iowa, but livestock are present in  every state. (See figs. 3 and 4 for the populations of cattle and swine by  state.) According to USDA documents, a large percentage of livestock in  the United States are kept on large farms, ranches, or feedlots (i.e., areas  or buildings where livestock are fed and fattened up), some with capacity  for 50,000 to 100,000 or more animals. Livestock are transported daily to  feeding facilities, markets, slaughter plants, and other farms or ranches.  For example, swine are often moved among multiple premises at different  stages of their life spans to accommodate their growth in size, among  other things. According to the swine industry, approximately 1 million  swine are on the road every day in transit to various stages of the  production process.

An FMD outbreak in the United States could have serious economic  consequences. A 2001 outbreak of FMD in the United Kingdom, for  example, resulted in the killing of more than 6 million animals, with direct  costs of more than $3 billion to the public sector and more than $5 billion  to the private sector. The extent of economic damage in the United  States would depend primarily on the duration and geographic extent of  the outbreak, the extent of trade disruptions, and how consumers reacted  to the disease and associated control measures, according to USDA. In a  large and long-lasting outbreak, control measures such as killing animals  and halting the transportation of animals could cause significant losses for  livestock operations. In addition, trade disruptions could have an  enormous impact because U.S. exports of livestock, meat, and dairy  products—together valued at more than $19 billion in 2017 based on  estimates from the U.S. Meat Export Federation and the U.S. Dairy  Export Council—would likely stop or be sharply reduced. In addition,  domestic consumers might be reluctant to purchase meat and animal  products such as milk during an FMD outbreak, even though the products  would be safe for people to consume, according to USDA.

Partly to protect the economic interests of the U.S. livestock industry, the  Animal Health Protection Act authorizes USDA to detect, control, and  eradicate diseases in livestock. USDA’s Animal and Plant Health  Inspection Service (APHIS) is the lead agency for responding to  outbreaks of foreign animal diseases, including FMD. According to  APHIS, in responding to an outbreak of FMD or any foreign animal  disease, APHIS, in coordination with state and industry partners, would  conduct the following activities, among others:

Surveillance. Observing animals for visible signs of disease and  analyzing data on locations and numbers of disease cases to detect  premises with the disease, determine the size and extent of an  outbreak, and determine whether outbreak control measures are  working.

Epidemiologic tracing. Gathering and analyzing data on cases of a  disease, premises with such cases, movement of infected animals,  and their potential contact with uninfected animals to locate other  animals or premises with the disease, understand the outbreak’s rate  and direction of spread, and investigate the source of the outbreak.

Diagnostic testing. Conducting approved and validated assessments  of samples taken from animals to identify infected animals or to  demonstrate that healthy animals are free of disease.

Applying quarantines and stop-movement orders. Restricting the  movement of infected or potentially infected animals, animal products,  and contaminated items to prevent the virus from spreading to healthy  animals.

Biosecurity  Biosecurity measures, which help minimize  disease spread, include the following: placing  signs indicating precautions personnel and  visitors must follow; establishing sign-in  procedures at entry points; removing dirt from  boots and disinfecting them prior to entering a  facility; using disposable personal protective  equipment, such as Tyvek suits, gloves,  masks, and boots, when entering premises;  disposing of contaminated items properly;  designating “clean” and “dirty” storage areas  in vehicles; and controlling movement on and  off premises.

Employing biosecurity measures. Taking steps, such as cleaning  and disinfecting trucks that travel between premises, to contain the  virus on infected premises and prevent it from spreading via objects or  equipment that can carry infection.

Stamping out and vaccination. Killing infected animals and  vaccinating uninfected animals—for example in buffer zones around  infected premises—to limit the spread of the virus.

Compensating owners. Paying owners fair market value for animals  and equipment that the government determines must be destroyed to  limit disease spread.

To help prepare for a potential FMD outbreak, APHIS and its partners  conduct preparedness exercises in which officials practice responding to  simulated FMD outbreaks. Such exercises range from small-scale,  narrowly scoped exercises to full-scale, broadly scoped exercises. For  example, some exercises focus on specific response tasks such as  electronic messaging between laboratories or shipping response supplies  to the field, and involve relatively few people for less than a day. Other  exercises simulate a wide range of response activities that APHIS and its  partners would use in an FMD outbreak, involve dozens of people from  different agencies and industry organizations in locations across the  country, and last for multiple days.

Multiple units within APHIS carry out these preparedness and response  activities at the agency’s headquarters in Maryland; field offices in 27  states and Puerto Rico; and the National Veterinary Services  Laboratories in Ames, Iowa, and on Plum Island, New York. APHIS’s  Foreign Animal Disease Diagnostic Laboratory on Plum Island, New York,  develops and performs diagnostic tests for foreign animal diseases,  including FMD.

Federal, State, Tribal, and Industry Roles Related to FMD Control

APHIS also works with federal agencies within and outside of USDA,  along with states, tribes, and academic and industry partners—all of  which have roles related to FMD control, as discussed below.

USDA’s Food Safety and Inspection Service is responsible for the  safety of meat, poultry, and egg products. Agency officials assigned to  slaughter establishments examine animals before processing to look  for visible symptoms of FMD, among other things.

USDA’s Agricultural Research Service conducts research on  agricultural problems of high national priority, including the FMD virus  and FMD vaccine.

USDA’s National Institute of Food and Agriculture invests in and  conducts agricultural research, education, and extension to help solve  national challenges in agriculture, food, the environment, and  communities. The agency has funded modeling of FMD spread and  research on potential economic impacts.

DHS has funded research on FMD vaccine and development of  response decisions tools, training, and equipment; sponsored  preparedness exercises; and developed emergency plans, among  other things. In an FMD outbreak, DHS may assume the lead for  coordination of federal resources if the Secretary of Agriculture  requests assistance from DHS. The Secretary of Homeland Security,  in coordination with the Secretaries of Agriculture, Health and Human  Services, the Attorney General, and the Administrator of the  Environmental Protection Agency, is to ensure that the combined  federal, state, and local response capabilities are adequate to  respond quickly and effectively to a major disease outbreak, among  other things, affecting the national agriculture or food infrastructure.

The Department of the Interior carries out disease surveillance of  wild animals and coordinates surveillance activities with state fish and  wildlife agencies, among other things. The Department of the Interior’s  U.S. Geological Service conducts research on wildlife diseases,  including FMD, and if needed in an FMD outbreak, would administer  diagnostic tests for wildlife.

The Federal Bureau of Investigation coordinates the federal  investigation of criminal activities through the Joint Terrorism Task  Force. If animals, livestock, or poultry are suspected targets of a  terrorist attack, or if any evidence suggests a foreign animal disease  may have been or could be intentionally introduced, USDA notifies the  Federal Bureau of Investigation to investigate.

State governments prepare plans for foreign animal diseases,  including FMD; conduct preparedness exercises; and would play a  key role in a response effort. In an FMD outbreak, a state animal  health official and an APHIS field official would co-lead initial response  efforts. For example, state governments might take immediate  actions, such as applying quarantines and stop-movement orders.

Tribal governments, like state governments, would play a key role in  initial response efforts and conduct activities similar to those of state  governments.

The National Animal Health Laboratory Network is a partnership of  59 federal, state, and university-associated animal health laboratories  throughout the United States, of which 45 are approved to administer  diagnostic tests for FMD.

Livestock industry organizations support communication and  education efforts with their members and the public, participate in  FMD preparedness exercises, and have helped develop some FMD  planning documents.

As part of its response to an FMD outbreak, APHIS may access vaccine  through the North American Foot-and-Mouth Disease Vaccine Bank  (vaccine bank), which is jointly administered by the United States,  Mexico, and Canada. Because finished vaccines have a short shelf life,  the vaccine bank manages a supply of vaccine concentrate, which can be  stored at extremely cold temperatures for about 5 years. Some of the  concentrate is stored at the Foreign Animal Disease Diagnostic  Laboratory on Plum Island, New York, and some at the manufacturer’s  facilities in Lyon, France. During an FMD outbreak, the manufacturer  would convert the concentrate into finished vaccine and ship it to the  United States. For the concentrate stored in the United States, the  vaccine bank would need to first ship it to the manufacturer overseas.  APHIS’s National Veterinary Stockpile coordinates logistics planning,  particularly for catastrophic outbreaks, and would be responsible for  delivering the finished vaccine to affected states, according to USDA  planning documents.

The FMD virus has seven distinct variations, or serotypes, and more than  60 subtypes within the serotypes, according to USDA documents. FMD  vaccine should be as closely matched to the outbreak subtype as  possible to provide more effective protection, according to USDA officials  and a document on FMD vaccination. A vaccine for one FMD subtype  may also provide good or partial immunity to other closely related  subtypes, but it would not generally protect against other serotypes. The  vaccine bank has concentrate for a number of FMD subtypes that pose  the greatest risk to North American livestock based on recommendations  from the World Reference Laboratory for FMD.

We have previously reported on APHIS’s management of foreign animal  diseases, including FMD. For example, in May 2015, we recommended  that USDA assess and address its veterinarian workforce needs for  emergency response to an outbreak of an animal disease such as FMD.  USDA agreed, in part, with the recommendation, and in 2017 hired  additional veterinarians. The agency is currently building a model to  develop workforce estimates for a large-scale FMD outbreak, according  to agency officials.

USDA’s Planned Approach Calls for Outbreak-Specific Strategies, Using Overarching Guidance to Implement the Strategies

USDA’s planned approach for responding to an FMD outbreak relies on  several different strategies emphasizing stamping out, vaccination, or  both, depending on factors such as the size of the outbreak. To aid  agency officials in implementing the strategies, USDA has developed  overarching guidance for responding to animal disease outbreaks and  detailed procedures for many response activities.

USDA’s FMD Response Strategies Emphasize Stamping Out or Vaccination, Depending on Factors Such as Outbreak Size and Resource Availability

USDA’s APHIS has developed several different, but not mutually  exclusive, outbreak response strategies that the agency will consider to  control and eradicate FMD in an outbreak as part of its planned approach,  according to USDA documents and officials. These strategies rely on  stamping out—killing and disposing of—infected and susceptible animals,  vaccination of uninfected animals, or both. For strategies involving  vaccination, options include killing and disposing of vaccinated animals  (vaccinate-to-kill), allowing the animals to be slaughtered and their meat  processed (vaccinate-to-slaughter), or allowing the animals to live out  their useful lifespan (vaccinate-to-live). Response strategies would likely  change as an outbreak unfolds, and might also vary by region or type of  animal affected, according to APHIS planning documents.

Over time, USDA’s FMD planned approach has evolved from relying  solely on stamping out to including vaccination strategies as it became  apparent that in many potential scenarios, reliance on stamping out alone  would not be effective or feasible. Specifically, in 2010, USDA’s Foot-and- Mouth Disease Response Plan: The Red Book (Red Book) first stated  that APHIS would consider vaccination strategies such as vaccinate-to- slaughter and vaccinate-to-live. In 2014 APHIS updated the Red Book  with the addition of a vaccinate-to-kill strategy to better distinguish what  would happen to animals if they were not eligible for slaughter. By 2016,  USDA had determined that complete stamping out of anything beyond a  small FMD outbreak was not a viable, effective, or sustainable response  strategy for the United States, according to USDA’s FMD vaccination  policy.

Experiences in preparedness exercises and foreign outbreaks of FMD  influenced a shift in USDA’s planned approach toward vaccination  strategies. In 2010, Japan and South Korea both experienced FMD  outbreaks and initially relied on stamping out combined with strict  movement restrictions. Japan stamped out about 300,000 cattle and  swine, and South Korea stamped out about 150,000 cattle and 3 million  swine—a third of the country’s total swine population. Despite these  efforts, FMD continued to spread in both countries until they implemented  vaccination strategies, according to USDA documents. A 2007 FMD  preparedness exercise, sponsored by the Texas Animal Health  Commission and USDA, found that killing and disposing of infected  animals in a livestock-dense area like the Texas panhandle would not be  feasible in a timely manner because of the large number of animals on  infected premises (e.g., 50,000 to 75,000 head of cattle on large cattle  feedlots). USDA learned that having vaccination strategies in place would  be necessary to effectively respond to an FMD outbreak.

If an FMD outbreak occurred, APHIS would select a response strategy or  multiple strategies, or it would modify strategies to achieve its FMD  response goals based on the unique circumstances of the outbreak,  according to agency planning documents. APHIS would do so in  consultation with affected states and tribes, and if the agency chose to  use vaccine, states would request it from USDA. According to agency  planning documents we reviewed, APHIS would consider a number of  factors when deciding on its approach, including the following:

FMD vaccine availability;  consequences of the outbreak (e.g., trade restrictions or loss of  valuable genetic stock); public acceptance of response strategy or strategies;  scale of the outbreak (i.e., number and size of infected premises);  rate of outbreak spread;  location of initial outbreak (e.g., isolated ranch versus livestock- producing area); movement of animals (number of locations that infected or potentially  infected animals have traveled to or through); and  federal and state resources available to implement response  strategies.

Resource needs vary among strategies and generally increase with the  scale of an outbreak, according to USDA planning documents. Having the  necessary resources available to implement a stamping-out response  strategy would include having qualified personnel to kill animals in  accordance with accepted protocols and having appropriate disposal  facilities. To implement strategies involving vaccination, APHIS would  need a sufficient quantity of vaccine, the resources for distributing and  administering the vaccine, and the diagnostic tests necessary to  distinguish between vaccinated and infected animals, according to  USDA’s FMD vaccination policy. If the scale of an outbreak were small,  and APHIS had access to sufficient resources, agency officials would  likely implement a stamping-out strategy in an attempt to quickly stop the  production of virus in infected animals and limit the outbreak’s spread,  according to agency planning documents. However, these planning  documents indicate that if the outbreak grew to a moderate regional, large  regional, national, or catastrophic scale, the resources required for  killing all infected and potentially infected animals, disposing of  carcasses, and paying compensation to livestock owners would quickly  multiply, and APHIS policy calls for strategies focused on vaccination,  according to USDA documents.

USDA Has Developed a Range of Documents to Guide Its FMD Response Strategies

Over time, USDA’s APHIS has developed various documents to guide its  response to FMD, including overarching guidance for responding to FMD  and other foreign animal diseases, procedures with in-depth operational  details, and plans to secure the nation’s food supply. To aid agency  officials in implementing FMD response strategies broadly, APHIS has  developed FMD response plans and guidance for responding to foreign  animal disease outbreaks more generally. For example, the Red Book  describes USDA’s FMD response strategies; identifies the capabilities  needed to respond to an FMD outbreak; and provides guidance on the  critical activities required during the response, including time frames for  these activities. The Red Book is intended for responders at all levels of  government and industry partners. For example, if a state official or a  livestock owner wanted to know the steps to test and confirm a positive  case of FMD, the Red Book explains the process and has a flowchart to  illustrate the steps. APHIS also has developed response manuals that  provide guidance relevant to foreign animal disease outbreaks, including  FMD. For example, a manual on roles and coordination provides an  overview of USDA’s framework for incident management, funding,  communication strategies, relationships, and authorities during a foreign  animal disease outbreak, including an FMD outbreak. APHIS also has  produced ready reference guides that condense guidance material from  these broader documents into short summary documents for training and  education purposes.

In addition, APHIS has developed standard operating procedures (SOP)  for many response activities. Some SOPs are specific to an FMD  outbreak, and others provide more general instruction on activities to  respond to foreign animal diseases. The FMD biosecurity SOP, for  example, describes steps responders at all levels of government and  industry partners can take to help prevent the spread of the virus, such as  protocols for putting on and taking off personal protective equipment (e.g.,  coverall suits, boots, and gloves); standards for separating “clean” and  “dirty” zones in vehicles and on premises; and instructions for cleaning  and disinfecting vehicles before arrival at and after departure from  different premises.

Many of the more general SOPs have proven useful during outbreaks of  other animal diseases and exercises simulating FMD outbreaks,  according to APHIS and state government officials, and APHIS has  revised them to incorporate lessons learned. For example, one state  animal health official said that during the 2014 avian influenza outbreak,  the SOP for disposing of poultry carcasses through composting was  initially insufficient because the poultry industry had not previously been  composting in all states. To improve consistency across states, APHIS  updated protocols during the outbreak and created composting protocols  for avian influenza-infected flocks and livestock to supplement the  agency’s disposal SOP, which addresses carcass disposal for foreign  animal diseases generally. These composting protocols expanded on  and clarified guidance to be used in subsequent outbreaks. In addition,  APHIS held training on composting procedures for birds and on large  animal composting, which could be part of an FMD response.

USDA, in coordination with industry, state, federal, and academic  representatives, has also developed supply plans to secure the nation’s  food supply and keep businesses operating during an FMD outbreak  while managing the risk of spreading the virus, which would decrease the  economic impact of an outbreak. To date, USDA and its industry and  university partners have developed Secure Milk Supply and Secure Pork  Supply plans and have partially completed a Secure Beef Supply plan.  These plans guide industry on managing uninfected premises and  uninfected animals during an FMD or other foreign animal disease  outbreak. For example, the Secure Milk Supply plan has guidance on  what producers can do to continue moving shipments of milk during an  outbreak, including how to implement enhanced biosecurity plans to  prevent the spread of FMD to their facilities. The sheep industry is  currently developing its own secure food and wool supply plan, according  to industry representatives.

USDA Would Likely Face Significant Challenges in Pursuing Its FMD Response Goals, Particularly regarding Vaccination

USDA would likely face significant challenges in pursuing its FMD  response goals of detecting, controlling, and containing FMD as quickly  as possible; eradicating FMD using strategies that seek to stabilize  animal agriculture industries and the economy; and facilitating continuity  of commerce in uninfected animals. We identified 11 challenge areas,  based on our review of USDA documents, interviews with agency officials  and others with expertise with FMD, and 29 responses to our  questionnaire. A majority of respondents indicated that in 10 of the 11  areas USDA would face challenges that are significant—that is, important  enough to be worthy of USDA action. (See app. I, fig. 7, for a summary of  the responses.) For the 11th area, which is communication and  coordination, opinions were split on whether the area would present  significant challenges. The 11 challenge areas, which sometimes overlap  or fall outside of USDA’s direct control, are described below. Examples of  actions USDA is taking to address these challenges are described later in  this report.

USDA would likely face surveillance challenges that could delay detection  of the first cases in an FMD outbreak. A majority (22 of 29) of  respondents to our questionnaire indicated that USDA would face  significant challenges in this area. FMD can spread without detection for  the following reasons:  there is no active surveillance for FMD, animals may not have visible signs until up to 4 days after becoming  signs can be difficult to notice in some species, and  infected wild animals could go undetected and spread the virus.

For initial detection of an FMD outbreak, USDA relies on passive  surveillance, waiting for producers or veterinarians to notice and report  visible signs. In contrast, for initial detection of other diseases, such as  bovine spongiform encephalopathy (commonly known as mad cow  disease), USDA has active surveillance programs in which animals are  routinely tested regardless of visible signs. According to USDA officials,  the cost and resources required to conduct active surveillance for initial  detection of an FMD outbreak would not be justified because the United  States has not had an FMD outbreak for decades and there is a risk that  false positives could create unnecessary disruptions. However, the  officials said the agency would likely use active surveillance during an  outbreak.

Passive surveillance, however, may not allow for timely detection of the  initial cases of FMD, particularly in sheep. FMD infection in sheep often  causes only mild signs or symptoms, such as an elevated temperature or  loose stool, and in some cases will not cause any overt signs or  symptoms at all, even though the animal may be spreading the virus,  according to representatives of the sheep industry. Therefore, an FMD  outbreak could become widespread before USDA detects the first cases.

Even if responders are able to detect FMD in domesticated animals  before an outbreak becomes widespread, wild animals may become  infected and spread the virus, posing additional challenges for USDA and  its partners. For example, the U.S. population of feral swine, which are  susceptible to FMD, is estimated at 6 million and is rapidly expanding,  according to APHIS. Detecting and controlling infected wild animals could  be extremely difficult, according to agency officials, and if not controlled,  these populations could serve as carriers for the disease. In addition,  limitations in diagnostic capabilities, discussed below, could hamper the  availability of data needed for surveillance, such as accurate information  on new cases of FMD.

USDA would likely face challenges related to its capability to diagnose  FMD. Such challenges include the lack of validated population-level  diagnostic tests and potentially insufficient resources to collect samples  and perform diagnostic testing in a large outbreak. A majority (24 of 29)  of respondents to our questionnaire indicated that USDA would face  significant challenges in this area. Currently, during an FMD outbreak,  USDA would rely on individual animal testing, given that it has not  validated any diagnostic tests that can be used for a group or population  of animals, according to USDA’s surveillance SOP. If an FMD outbreak  expands, the ability to test a large number of animals quickly with minimal  resources would be useful for USDA. In a 2017 study of the potential  uses of a bulk milk test for FMD in dairy cattle, for example, USDA found  that 720 bulk milk tests could replace over 35,000 individual animal tests  with the same level of confidence in disease status. However, the study  identifies additional work needed to implement bulk milk tests.

USDA and state officials investigate suspected cases of FMD on  previously uninfected premises, according to USDA documents. To do so,  USDA or state officials travel to the suspected premises—sometimes  over long distances—collect samples from the animal or animals, and  send them to a qualified laboratory for diagnostic testing. During an  outbreak, massive quantities of diagnostic testing may need to be  conducted, straining the capacity of federal and state laboratories that are  qualified to investigate suspected cases of FMD, and potentially causing  delays in detecting infected premises, according to both an after-action  report for a preparedness exercise and agency officials. In addition,  USDA officials we interviewed expressed concern that diagnostic kits  used for these individual animal tests would be in short supply during an  outbreak and said that they do not currently know how much time it would  take for manufacturers to produce more. In the event of a large FMD  outbreak, delays in getting diagnostic results could slow USDAs ability to  detect, control, and contain an outbreak.

USDA would likely face challenges in the area of information  management during an outbreak, including incompatible data systems at  the state and federal levels or between diagnostic laboratories and USDA  and responders who lack familiarity with USDA data systems. A majority  (20 of 29) of respondents to our questionnaire indicated that USDA would  face significant challenges in this area.

USDA and state data systems track information on registered livestock  premises and animals. In addition, USDA has an emergency response  database for collecting and analyzing data on disease outbreaks and  managing response resources. However, state data systems cannot  always communicate directly with USDA’s data systems because they  use different software, according to two state animal health officials. Such  impediments to communication could delay information sharing about the  location of infected and susceptible animals. One industry representative  said that such delays could prolong decisions about permits for  uninfected animals to move, disrupting industries’ continuity of business.  According to an academic researcher, interruptions in movement of  animals could cause processing facilities to either close, operate at a  diminished capacity, or be overwhelmed by a backlog of animals once  movement is restarted, leading to animal welfare concerns. These  disruptions could present challenges for USDA to facilitate continuity of  commerce in uninfected animals, one of its response goals.

USDA’s ability to control an outbreak could also be impaired if responders  lack familiarity with USDA data systems. For example, according to a  USDA after-action report, during the 2014 avian influenza outbreak, some  responders were unfamiliar with USDA’s system for entering outbreak  response information, resulting in incorrect usage or underutilization of  the system. As a result, USDA’s overall response was slower than it  would have been if timely information had been available.

USDA would likely face challenges related to the traceability of animals  (i.e., the ability to trace their locations and movements) after an outbreak  was detected. We found that these challenges result from insufficient use  of identification numbers for livestock premises (such as farms and  ranches) and individual animals to enable tracing of infected, exposed,  and susceptible animals, and from identification numbers that cannot be  easily read (e.g., because they are not electronic). A majority (25 of 29) of  respondents to our questionnaire indicated that USDA would face  significant challenges in this area. In an outbreak, responders would use  premises and animal identification numbers, if available, to trace the  location and movements of infected animals to identify other animals that  may have been exposed. They would also use the identification numbers  to locate all susceptible animals in the region, in order to notify owners  about the outbreak and any response measures in place, such as stop- movement orders. These activities would be hampered without the  identification numbers. For example, Iowa and Texas regulations do not  require producers to register all of their animals with the state. Also,  record keeping varies at individual farms and ranches, where some  producers have electronic records, but others have no written records or  rely on hand-written paper documents, according to USDA documents.  Searching through records by hand at individual farms could take days  rather than the hours that it would take if the records were electronic,  according to a USDA planning document. Without timely and accurate  tracing through the use of premises and animal identification numbers,  USDA may face challenges controlling and containing an FMD outbreak  and facilitating continuity of commerce in uninfected animals.

In addition, some animals have identification numbers on ear tags that  must be read visually, which could slow USDA’s efforts to control and  contain an outbreak. In an outbreak, responders would need to inspect  animals with such ear tags to manually read and record the identification  numbers for individual animals. In contrast, for animals with electronic  tags, responders could use electronic readers, which can accurately read  identification numbers for a group of animals from a distance of up to 12  feet, according to a 2016 USDA study on electronic identification for  livestock. One industry representative said that the beef cattle industry  has not widely implemented electronic identification because it is difficult  for many operators to justify the added cost of purchasing and attaching  an electronic tag for each animal.

In an FMD outbreak, USDA would likely face biosecurity challenges  including lack of sufficient biosecurity on some premises, difficulty in  implementing biosecurity measures for certain species, and lack of  documentation (such as a written plan) specifying what measures are  currently in place. A majority (20 of 29) of respondents to our  questionnaire indicated that USDA would face significant challenges in  this area. If sufficient biosecurity measures are not consistently in place  on farms, ranches, and feedlots, people and vehicles may inadvertently  spread the FMD virus when they travel among premises, impeding  USDA’s ability to control and contain an outbreak. For example during the  2001 FMD outbreak in the United Kingdom, poor biosecurity and livestock  owners’ movements between scattered farms led to the introduction of FMD in previously uninfected areas, according to a 2002 report by the  United Kingdom’s National Audit Office.

Some livestock owners have not implemented extensive biosecurity  measures on their premises, in part because they have not experienced a  recent animal disease outbreak and measures may be difficult or  expensive to implement, according to an industry representative. In  addition, it may be difficult to implement biosecurity measures for certain  species. For example, cattle feedlots operate outdoors and may have  unrestricted points of entry and exit, so it can be more difficult and costly  to control access and implement other biosecurity measures.

In addition, even if producers have biosecurity measures in place, these  measures may not be sufficiently documented to facilitate continuity of  commerce in uninfected animals. According to USDA guidance  documents, during an FMD outbreak, premises in areas with movement  restrictions will be required to obtain permits to move any animals or  animal products. To obtain such a permit, producers must show that they  are not contributing to the spread of disease or putting their animals at  risk of exposure, and producers without documented biosecurity plans  may face delays moving their animals. According to swine industry  representatives, even swine farms with biosecurity procedures do not  always document such procedures or the steps they have taken.

USDA would likely face depopulation challenges during an FMD  outbreak, including limited capability for killing large numbers of animals  in a timely manner and difficulties owing to the large size of some animals  affected by FMD. A majority (22 of 29) of respondents to our  questionnaire indicated that USDA would face significant challenges in  this area. For example, USDA officials said killing animals in large  feedlots—which can hold 50,000 or more animals—would quickly  overwhelm resources, such as the staff and equipment required to kill  animals. USDA policy calls for depopulating infected premises within 24  hours, but this may not be feasible on large livestock operations because  the animals have to be killed individually, which would be time-consuming  according to an industry representative. If infected premises are not  quickly depopulated, animals will continue producing the virus and  increase the risk of infecting animals on additional premises, hampering  USDA’s ability to control and contain an outbreak. Rapid depopulation of  infected swine is particularly critical to containing the spread of an  outbreak because swine are known as amplifiers of FMD virus, producing  and excreting 3,000 times more virus than cattle or sheep, according to  USDA documents.

USDA would likely face disposal challenges during an FMD outbreak,  including the feasibility and logistics of disposing of a large number of  animal carcasses, public concern about disposal options, and the  environmental impacts of disposal. A majority (25 of 29) of respondents to  our questionnaire indicated that USDA would face significant challenges  in this area.

In a large FMD outbreak, millions of cattle could be affected. It is possible  that FMD can survive for several months on a frozen carcass, according  to USDA documents, so if such carcasses are not disposed of properly,  they could pose a risk for spreading FMD, hampering USDA’s efforts to  control and contain an outbreak. Disposing of the carcasses of a 50,000- head herd of cattle from a large feedlot would be a massive effort: the  total weight for disposal could be as much as 30,000 tons, or about 1,500  dump truck loads to move all the animals to disposal sites, according to  an industry representative. One state animal health official stated that  disposal of one or two herds may be possible, but if an outbreak were  more widespread, the state would quickly run out of options.

In addition, certain disposal strategies, such as incinerating large piles of  carcasses, may cause a negative public reaction, according to an industry  representative, USDA’s disposal SOP, and state animal health officials.  Figure 5 illustrates carcass disposal during a 2001 FMD outbreak in the  United Kingdom, where the government implemented a policy of  stamping out all susceptible animals within 3 kilometers of known FMD  cases. In reaction to the policy, the public staged protests, and  businesses in rural areas lost customers who stayed away because of the  striking images in the media, according to a 2002 report by the University  of Newcastle.

Finally, carcass disposal can create environmental impacts, such as  when a burial site contaminates the groundwater or incineration  contaminates the air. In general, states regulate disposal, including such  things as the timing (e.g., within 24 hours of an animal’s death) and the  method of disposal (e.g., prohibiting outdoor incineration or specifying  that up to 7 cattle may be buried per acre per year). In an FMD outbreak,  large numbers of carcasses could make it difficult to comply with such  regulations.

USDA would likely face resource challenges in pursuing its FMD  response goals, including insufficient numbers of incident responders to  effectively implement USDA strategies in a medium or large outbreak, as  well as insufficient resources devoted to preparedness planning in some  states. A majority (23 of 29) of respondents to our questionnaire indicated  that USDA would face significant challenges in this area.

During the 2014 avian influenza outbreak, there were difficulties quickly  providing response resources, such as personnel and equipment, to  rapidly stamp out affected flocks, according to a USDA after-action report.  According to an academic researcher, an FMD outbreak would be  significantly more difficult to handle than recent avian influenza outbreaks.  One state official noted that in his state there is not enough of a workforce  to adequately respond to an outbreak, and there is no assigned workforce  at the local level. For example, this official noted that his state employed  only two veterinarians and a few animal health technicians to collect  samples for testing in the event of an FMD outbreak. Other state animal  health officials expressed concern that states and counties will have  difficulty fielding adequate workforces to inspect animal transport vehicles  and implement stop-movement orders.

Insufficient preparedness planning in some states could also hamper  response efforts, according to a response to our questionnaire from an  academic researcher with expertise in FMD preparedness. Some states  have not allocated resources to develop FMD response plans, including,  for example, the conditions that would trigger a stop-movement order.  States typically control intrastate movement under the state’s authority,  and if states delay issuing stop-movement orders, it may be more difficult  for USDA to control and contain an outbreak.

Communication and coordination may be an area where USDA could  face challenges during an FMD outbreak because of ineffective external  or internal communications and unclear roles and responsibilities.  Responses to our questionnaire in all categories (federal and state  government officials, industry representatives, and academic  researchers) were mixed about whether communication and coordination  was an area with significant challenges. Specifically, 11 respondents said  it was an area with significant challenges, 12 said it was not, and 6 were  unsure. One industry respondent who said that the area was not a  challenge cited a team of industry representatives that is working with  USDA and states to prepare for an FMD outbreak. On the other hand,  during a 2016 FMD preparedness exercise in Texas, coordination  between USDA and other participants was at times inadequate. For  example, during the exercise USDA and the Texas Animal Health  Commission shared leadership of the response effort, and some  respondents cited frustration with this top-down leadership structure  because they were accustomed to emergency management practices  and protocols designed for incidents such as natural disaster response  efforts, which are generally initiated at the local level. Participants  commented that they were confused about who did what and said that  coordination needs to be improved between USDA and local  governments, according to an after-action report. Also, communication  across participating agencies broke down. For example, information from  USDA on stop-movement orders, the size of the quarantine zone, and the  number of sites quarantined did not reach all stakeholders in a timely  manner, according to an after-action report.

Compensating livestock owners for animals or equipment that the  government determines must be destroyed to limit the spread of FMD  would likely pose various challenges for the agency. USDA would provide  the owners with up to 100 percent of the expenses of purchase,  destruction, and disposition of animals or materials required to be  destroyed, based on the agency’s appraisal of the fair market value.  Doing so would likely pose various challenges for the agency, according  to USDA and state government officials. A majority (19 of 29) of  respondents to our questionnaire indicated that USDA would face  significant challenges in this area. Such challenges include uncertainties  about fair appraisal methods (especially when an outbreak has caused  livestock prices to decline), owners resisting killing their animals if  compensation rates are too low, and the potentially massive scale of  compensation payments. According to USDA economists, if trade  restrictions were imposed during an FMD outbreak, the fair market value  of animals and their products would likely drop as a result of oversupply.  USDA’s response to the outbreak could be slowed if producers brought  legal challenges to stop the stamping out of their herds because they  were not satisfied with compensation levels, a scenario that took place in  a 2018 USDA-led exercise simulating the first few days of an FMD  outbreak. Moreover, in a widespread FMD outbreak, the scale of federal  compensation payments could be substantial. For example, in the 2001  United Kingdom FMD outbreak, compensation costs were estimated at  over $1 billion for the killing of about 6 million animals. Given the larger  size of the livestock industry in the United States, federal compensation  costs could be much higher, depending on the number of animals killed  as part of the response.

USDA would likely face challenges related to vaccination, an area of  particular importance given vaccination’s central role in USDA’s strategies  for pursuing its response goals. All 29 respondents to our questionnaire  agreed that the challenges USDA faces related to vaccination are  significant. In particular, USDA does not have access to sufficient vaccine  to achieve its response goals under many potential outbreak scenarios,  and there is not consensus about how to allocate the limited supply,  according to USDA officials and documents. Other challenges in this area  relate to the timing and logistics of obtaining, distributing, and  administering vaccine and to scientific, procedural, and infrastructure  issues in vaccine production.

Supplies of FMD vaccine concentrate in the vaccine bank may be  sufficient to help control and eradicate a small, localized outbreak, but it is  unlikely that they would be sufficient to stop a larger outbreak, according  to USDA planning documents and officials. With a vaccine that is  matched to the appropriate FMD subtype, a single dose can protect cattle  for 6 months, and two doses are required to provide the same protection  to swine. APHIS’s 2016 FMD vaccination policy states that 25 million  doses for each of 10 subtypes of the virus is an appropriate minimum  target to have available. However, the United States currently has  access to only 1.75 million doses of each subtype available in the vaccine  bank, according to USDA documents. In the United States, there are 24  states in which the number of livestock exceeds the doses available in the  vaccine bank, according to USDA documents. In a 2016 report to  Congress, USDA stated that the cost to reach its target of 25 million  doses would be about $125 million, which would be about 10 percent of  APHIS’s budgetary resources in fiscal year 2016. In addition, because the  vaccine concentrate has a 5-year shelf life, USDA would incur costs to  routinely replace the supply of concentrate, according to agency officials.  The Agriculture Improvement Act of 2018 contains a provision that directs  the Secretary of Agriculture to establish a national animal vaccine and  veterinary countermeasures bank, and to prioritize the acquisition and  maintenance of sufficient quantities of FMD vaccine and accompanying  diagnostic products.

The need for additional FMD vaccine was reinforced by a 2016 survey of  states by USDA and Iowa State University. On the basis of responses  from 32 state animal health officials, the authors estimated that in a  widespread or national outbreak, states would plan to use on average 4.2  million doses during the first 14 weeks of the outbreak. Based on these  estimates, a vaccine request from a single state could greatly exceed the  1.75 million doses available per subtype in the vaccine bank’s supply.

Moreover, if an FMD outbreak occurred in Texas or Iowa, the states with  the largest cattle and swine populations, respectively, the available  vaccine supply would provide a single dose for about 14 percent of  Texas’s 12.3 million cattle or the required two doses for about 4 percent  of Iowa’s 22.8 million swine. Texas’s and Iowa’s cattle and swine  populations together make up about 24 percent of the combined  population of cattle and swine nationwide. Figure 6 illustrates the vaccine  doses needed to protect cattle and swine in Texas and Iowa compared  with the currently available FMD vaccine bank supply of 1.75 million  doses per subtype.

In addition, because of the large number of FMD subtypes present  around the world, and because the FMD virus is constantly mutating, it is  possible that an FMD subtype could be introduced in the United States  that is not covered by vaccines currently in the vaccine bank. According  to a representative from an FMD vaccine manufacturer, producing a  vaccine for a new subtype of FMD could take from 6 to 18 months,  depending on whether the subtype was known and other factors.

Because of the limited supply of vaccine and the potentially high demand  for it, USDA would likely face the challenge of deciding how to allocate it  in an FMD outbreak. In a 2016 survey of 13 industry veterinarians, there  was no consensus within the beef, dairy, and swine industries about  priorities for the vaccine. Specifically, USDA and Iowa State University  asked the veterinarians to rank the importance of vaccinating various  populations (e.g., bull studs, lactating cows, and boar studs) within the  beef, dairy, and swine industries, assuming there was only enough  vaccine to vaccinate 25 to 50 percent of animals in a specified area. The  responses varied widely, with high and low rankings for nearly every  population of animals.

The timing and logistics of obtaining, distributing, and administering the  FMD vaccine could also pose challenges. The timing to reformulate the  banked vaccine would pose challenges for USDA in an outbreak,  according to respondents to our questionnaire. In addition, in March 2005,  we found that USDA would not be able to deploy vaccines rapidly enough  to contain a widespread FMD outbreak. After USDA requests FMD  vaccine from the vaccine bank, vaccine manufacturers could take from 4  to 13 days to finish and ship all of the requested vaccine to the United  States, during which time the virus could spread within the livestock  population, according to USDA documents. If the vaccine bank’s supply  of concentrate is exhausted during an outbreak and more is needed,  manufacturers may take several months to produce it, according to a  vaccine manufacturer.

After obtaining the vaccine, USDA would distribute it to affected states,  and the states would distribute it to veterinarians, producers, or others  who would be responsible for administering vaccine, according to USDA  and state FMD vaccination documents. Many states do not currently have  vaccination plans in place and may not have identified the warehousing  locations, staff needs, and tracking required to efficiently distribute FMD  vaccine, according to agency and state government officials, which could  slow USDA’s efforts to contain and control an outbreak. States with  vaccination plans may be able to more quickly and effectively distribute  and administer FMD vaccine during an outbreak. For example, California  has a vaccination plan that details how it would receive, distribute, and  administer FMD vaccine while maintaining the appropriate temperatures  and documentation. The plan includes details such as the supplies  needed for administering FMD vaccine to cattle.

Scientific, Procedural, and Infrastructure Issues

USDA faces challenges in obtaining vaccine and using it in a response  effort because of scientific, procedural, and infrastructure challenges  related to the vaccine and its production. There are very few vaccine  manufacturers in the world with the capacity to produce most of the FMD  vaccine subtypes and meet the quality standards required by the United  States, according to agency officials. Further, there is currently no  production capacity for FMD vaccine in the United States because  dedicated infrastructure is not in place to produce vaccines without live  virus. There is a statutory prohibition against working with live FMD virus  on the U.S. mainland, absent a permit granted by the Secretary of  Agriculture, and live virus is needed to produce conventional vaccines.  To work within this constraint, USDA’s Agricultural Research Service  (ARS) and DHS developed new technologies to produce vaccine using  modified versions of the virus that are unable to cause or transmit  disease. The agencies transferred these technologies to vaccine  companies that are investing in their development, according to USDA  officials.

In 2018, the Secretary of Agriculture announced that vaccine companies  could apply for permits to work with a specific modified, noninfectious  version of the FMD virus on the mainland. One company has exclusive  rights to use this modified version, which was developed and patented by  ARS. The company plans to produce FMD vaccine in the United States,  but it could take several years to license the initial product, complete the  necessary permitting procedures, and build manufacturing infrastructure,  according to USDA documents and a company official.

Using FMD vaccine to respond to an outbreak presents additional  challenges that are related to limitations of FMD vaccines. Specifically,  animals may take up to 28 days after vaccination to develop protective  immunity to FMD, depending on the species, potency of vaccine, and  other factors. Even after 28 days, some vaccinated animals may not be  fully immune to FMD and may continue spreading the virus despite  having no visible signs of infection, according to USDA documents.

USDA Has Identified Actions to Mitigate Challenges in Responding to FMD but Has Not Prioritized or Monitored Their Completion

To mitigate challenges in responding to potential FMD outbreaks, USDA’s  APHIS has identified corrective actions through preparedness exercises,  surveys, and lessons learned in other outbreaks, as called for in its SOPs.  However, APHIS generally does not follow its SOPs for prioritizing or  monitoring the completion of these actions.

USDA Has Used Preparedness Exercises, Surveys, and Lessons Learned in Other Outbreaks to Identify Actions to Mitigate FMD Challenges

A USDA SOP outlines a process for identifying corrective actions to  improve the agency’s preparedness for outbreaks of foreign animal  diseases. According to the SOP, APHIS is to identify corrective actions  after preparedness exercises and animal disease incidents. Consistent  with this SOP, APHIS identifies corrective actions for FMD preparedness  through exercises simulating FMD outbreaks, surveys of agency officials  and others, and lessons learned from outbreaks of other diseases. More  specifically, see the following:

APHIS sponsors FMD preparedness exercises and participates in  some such exercises that other federal or state agencies sponsor.  After an exercise, the sponsoring agency generally prepares an after- action report that specifies corrective actions, and may include a  responsible party for and a date for completing each action. APHIS  has after-action reports for more than 40 FMD preparedness  exercises that it sponsored or participated in from 2007 through 2018,  which include corrective actions for USDA and APHIS.

APHIS conducts annual surveys of its staff and others—including  state government officials, industry representatives, and academics— to identify corrective actions related to preparedness and response  training needs.

APHIS identifies corrective actions for FMD preparedness based on  lessons learned after outbreaks of other diseases. For example, some  of the actions that APHIS identified after outbreaks of avian influenza,  such as improving a database used for emergency response, could  also help the agency mitigate challenges it would face in an FMD  outbreak, according to agency officials.

APHIS has identified dozens of corrective actions in all 11 of the areas  where we identified challenges for USDA in pursuing its FMD response  goals. APHIS has taken corrective actions in each area. For example, to  help mitigate the challenge of insufficient biosecurity on some premises,  the agency partnered with Iowa State University to offer producers across  the nation training on developing enhanced biosecurity plans for  implementation during a foreign animal disease outbreak. However,  APHIS has not yet taken some other corrective actions that it has  identified.

According to agency officials and experts we interviewed, these corrective  actions can help mitigate, but may not completely resolve, the challenges  identified. Some challenges may be outside USDA’s control to fully  resolve. For example, the logistical challenges of carcass disposal could  be overwhelming in a large-scale outbreak, which could generate  thousands of tons of carcasses. A corrective action calling for training on  carcass management may help educate FMD responders about disposal  methods or preventing environmental impacts; however, such training  may not fully resolve the challenge.

Table 1 shows examples of corrective actions identified by USDA in after- action reports, planning documents, other agency documents, or  interviews, which the agency has taken or not yet taken for the 11  challenge areas we identified.

Some of the corrective actions that USDA has identified and taken relate  to the challenge area of vaccination. For example, to help speed access  to vaccine, in 2018, the Secretary of Agriculture announced that vaccine  companies could apply for permits to enable them to develop and  produce certain types of FMD vaccine in the United States in the future,  thereby avoiding delays from producing the vaccine overseas and  shipping it here. Also, APHIS officials have used an FMD predictive  model to evaluate the effectiveness of different vaccination schemes at  the state level, and they told us that they plan to conduct a similar  analysis at the national level. The results could help inform USDA’s  vaccine prioritization decisions in advance of an outbreak, according to  the officials.

USDA has also begun implementing other corrective actions that have  been identified related to FMD vaccination, although more work remains.  For example, in February 2009, we recommended—and USDA agreed— that it should detail in a contingency response plan how a response using  vaccines would be implemented. Similarly, after-action reports for 2013  and 2016 preparedness exercises highlighted the need for procedures to  guide the implementation of FMD vaccination strategies. APHIS has  taken or planned several steps to help address this need:  In 2009, APHIS began drafting vaccine implementation procedures  but realized that the national procedures needed to be developed in  collaboration with states because of variation among states in their  predominant industries, agriculture infrastructure, and government  resources. When more states have developed vaccination  implementation procedures, APHIS may revise and finalize the  national procedures originally drafted in 2009, according to agency  officials.

APHIS’s National Veterinary Stockpile developed plans in 2009 and  2011 outlining how some aspects of a vaccination strategy would be  implemented. Specifically, in 2009 it developed a template that  states and tribes can use to develop their own plans, and in 2011 it  prepared a logistical plan for distributing FMD vaccine to the field. The  National Veterinary Stockpile also held preparedness exercises from  2008 to 2018 for states and tribes to practice requesting, receiving,  and delivering the vaccine and to obtain information that could help  APHIS develop national vaccination procedures.

From 2011 to 2018, APHIS and the California Department of Food  and Agriculture worked together to draft detailed procedures for  implementing an FMD vaccination strategy in California. The draft  procedures and related planning documents are intended to serve as  templates to help other states develop such procedures, according to  agency officials. APHIS also piloted a workshop on FMD vaccination  planning in October 2018 and plans to hold related preparedness  exercises with states from 2019 to 2021.

APHIS Does Not Consistently Follow Its Procedures for Prioritizing Corrective Actions and Monitoring Their Completion

Although APHIS has identified dozens of corrective actions for FMD  preparedness, it has not consistently followed its SOP for prioritizing all of  the actions and monitoring progress in implementing them. Specifically,  once corrective actions have been identified, APHIS’s SOP calls for  prioritizing the actions in an improvement plan, and monitoring the actions  to track their completion. APHIS has sometimes designated actions  related to FMD vaccination as high priority during annual management  meetings, but not all corrective actions have been prioritized, according to  agency officials. For example, a 2016 corrective action called for USDA to  conduct an exercise to explore roles, responsibilities, and activities  related to recovery from a large-scale animal disease outbreak. However,  as of December 2018, this action has not been prioritized in an  improvement plan, according to the after-action report and an agency  official.

In addition, corrective actions have sometimes been identified multiple  times without being tracked to completion. For example, an after-action  report for a 2007 exercise found that a process for making vaccine- allocation decisions was needed and suggested that a vaccine advisory  group could assist with doing so. A 2014 after-action report stated that  processes governing vaccine prioritization and allocation were not clear  and identified a corrective action calling for USDA to develop a federal- level doctrine for vaccine prioritization and allocation. USDA’s 2016 FMD  vaccination policy states that APHIS, in coordination with state, local, and  industry stakeholders, should consider developing processes,  procedures, and strategies for prioritizing the use of currently available  vaccine in an outbreak. However, APHIS has not developed processes,  procedures, or strategies for prioritizing and allocating its supply of FMD  vaccine, according to agency officials. The officials said they have not  developed such a process because of limited resources and competing  priorities. Also, it would require participation from state and industry  stakeholders, and given the small quantity of FMD vaccine relative to the  large number of susceptible animals in the country, the stakeholders have  had little incentive to devote the necessary time to the issue, according to  agency officials.

More generally, agency officials told us that the agency has not prioritized  or monitored completion of some corrective actions because they have  been responding to actual outbreaks of animal and plant diseases. They  also noted that they have limited resources for FMD preparedness, which  may make it difficult for them to complete all of the corrective actions that  have been identified. However, for avian influenza preparedness, APHIS  compiled and prioritized more than 300 corrective actions in a database  and tracked more than 200 of them to completion. Through this process,  it completed nearly all of the 111 high-priority actions and over 100  moderate-priority actions, according to its database as of May 2018. For  example after the 2014 avian influenza outbreak, APHIS completed  corrective actions that improved its response to a subsequent outbreak in  2016, according to agency documents. The corrective actions addressed  such issues as how to quickly depopulate and dispose of infected poultry  and efficiently compensate affected producers. APHIS continues to  monitor its progress in implementing the remaining corrective actions for  that disease, according to agency officials.

APHIS’s SOP calls for prioritizing corrective actions to identify the most  beneficial use of resources. The SOP also calls for monitoring corrective  actions to track their completion so that APHIS can improve its response  capabilities and correct problems or deficiencies identified in exercises or  incidents. Without following its SOP to prioritize corrective actions for  FMD preparedness, APHIS cannot ensure that it is allocating its limited  resources toward implementing the most beneficial actions. And without  following its SOP for monitoring the corrective actions, APHIS cannot  ensure that the highest-priority actions are completed.

APHIS has taken important steps to prepare for an FMD outbreak and to  mitigate challenges it may face in responding to one. For example, the  agency has developed an extensive collection of strategy and guidance  documents, held FMD preparedness exercises to practice response  activities, and identified dozens of corrective actions and completed some  of these actions. However, APHIS has not yet completed other corrective  actions, including actions that have been identified multiple times, such as  developing a process for prioritizing and allocating the limited supply of  FMD vaccine.

APHIS has an SOP for prioritizing and monitoring corrective actions. By  following this SOP for avian influenza preparedness, the agency  succeeded in prioritizing more than 300 corrective actions and tracking  over 200 corrective actions to completion, including nearly all high-priority  actions. In contrast, for FMD preparedness, APHIS has not consistently  prioritized or monitored the corrective actions it has identified. Without  following its SOP to prioritize and monitor corrective actions for FMD  preparedness, APHIS cannot ensure that it is allocating its limited  resources to the most beneficial actions to prepare for a possible FMD  outbreak.

We are making the following two recommendations to USDA:

The Administrator of the Animal and Plant Health Inspection Service  should follow the agency’s SOP to prioritize corrective actions for  FMD preparedness. (Recommendation 1)

The Administrator of the Animal and Plant Health Inspection Service  should follow the agency’s SOP to monitor progress and track  completion of corrective actions for FMD preparedness.  (Recommendation 2)

We provided a draft of this report to USDA and DHS for review and  comment. USDA provided comments, reproduced in appendix II, in which  it agreed with our recommendations. In addition, USDA and DHS  provided technical comments, which we incorporated as appropriate.

In response to our recommendations, USDA said that, starting in the  second quarter of fiscal year 2019, APHIS will implement the agency’s  SOP and prioritize corrective actions to be tracked in its corrective actions  database, as we recommended. USDA also said that, starting in the third  quarter of fiscal year 2019, APHIS will assess and update the items  related to FMD in its corrective actions database, as we recommended. In  addition, USDA said that APHIS will track accomplishments it makes  under a related provision of the Agriculture Improvement Act of 2018.

We are sending copies of this report to the appropriate congressional  committees, the Secretary of Agriculture, the Secretary of Homeland  Security, and other interested parties. In addition, the report is available at  no charge on the GAO website at http://www.gao.gov.

If your or your staff have any questions about this report, please contact  me at (202) 512-3841 or morriss@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 III.

Appendix I: Objectives, Scope, and Methodology

This report (1) describes the U.S. Department of Agriculture’s (USDA)  planned approach for responding to a foot-and-mouth disease (FMD)  outbreak; (2) identifies what challenges, if any, USDA would face in  pursuing its FMD response goals; and (3) examines how USDA identifies,  prioritizes, and monitors corrective actions to mitigate these challenges.

To describe USDA’s planned approach for responding to an FMD  outbreak, we reviewed relevant legislation and USDA strategy and  guidance documents. We also interviewed officials from USDA’s Animal  and Plant Health Inspection Service (APHIS) at the agency’s  headquarters in Riverdale, Maryland; laboratories on Plum Island, New  York, and in Ames, Iowa; center for epidemiology and animal health in  Fort Collins, Colorado; and center for veterinary biologics in Ames, Iowa;  and officials from the Department of Homeland Security (DHS) and the  Agricultural Research Service (ARS) at DHS’s Plum Island Animal  Disease Center on Plum Island, New York. We selected these officials to  interview because of their knowledge about USDA’s planned approach,  their involvement in preparing for an FMD outbreak, and the roles they  would play in responding to such an outbreak.

To identify what challenges, if any, USDA would face in pursuing its FMD  response goals, we first came up with a list of potential challenge areas.  To develop the list of potential challenge areas, we reviewed USDA  documents, reports about FMD outbreaks in other countries, and after- action reports from 41 preparedness exercises in the United States from  2007 to 2018 in which officials practiced responding to simulated FMD  outbreaks and identified emerging challenges. The preparedness  exercises included small-scale as well as large-scale ones with a variety  of participants, durations, and response activities. We also interviewed  APHIS headquarters staff and field staff in Iowa (the state with the most  livestock); APHIS and ARS laboratory officials; state animal health  officials in California, Colorado, Iowa, and North Carolina; representatives  from the beef cattle, dairy cattle, swine, and sheep industries; and  academic researchers with expertise in this area. We selected the  individuals to interview based on their knowledge about challenges that  USDA could face in pursuing its FMD response goals, their central role in  preparing for an FMD outbreak, and recommendations from other  interviewees, as well as diversity in geographic location. We also visited a  swine farm and cattle feedlot in Iowa and interviewed the owners. We  selected a swine farm and cattle feedlot to visit because swine and cattle  were the livestock industries with the greatest populations of animals in  the United States in 2016. We identified a list of 11 potential challenge  areas.

To confirm the significance of the challenge areas, we used a  questionnaire with the list of potential challenge areas. To select the  questionnaire recipients, we identified four categories of people who are  knowledgeable about challenges that USDA could face in pursuing its  FMD response goals, including those who could be involved in a  response effort. The four categories are (1) federal government officials,  (2) state government officials, (3) livestock industry representatives, and  (4) academic researchers with expertise in FMD preparedness. For  categories with multiple individuals, we selected individuals to represent  relevant units within APHIS, ARS, and DHS (e.g. headquarters; field  offices; laboratories; surveillance, preparedness and response services;  and science, technology, and analysis services); different livestock  industries (beef cattle, dairy cattle, swine, and sheep); and states with  relatively high livestock populations. We asked the recipients whether  USDA would face a significant challenge in each of the 11 areas and  whether they knew of other challenge areas we had not listed. We  defined significant to mean a challenge that is sufficiently great or  important enough to be worthy of USDA action to address the challenge.

We initially sent the questionnaire with potential challenges to 39  recipients. Two federal officials had retired from their positions, so we  sent the list to their replacements. Of the 39 recipients, we received  responses from 28. We also included an additional response that APHIS  provided from an official who we had not initially contacted and who had  relevant expertise, for a total of 29 responses. Despite two follow-up  attempts, we did not receive responses from 11 recipients, including both  recipients from ARS, 5 of the 18 from APHIS, 3 of the 10 state animal  health officials, and 1 of the 2 national animal health laboratory network  officials (these are affiliated with universities). Figure 7 shows the  categories of respondents and their responses in each of the11 challenge  areas.

Since we used a nonprobability sample, the results are not generalizable  to all government officials, livestock industry officials, or FMD experts, but  the responses helped confirm the list of 11 challenge areas and provided  illustrative information about each one.

We reviewed challenges related to vaccination for FMD in greater depth  than other challenges because of the significant role vaccination could  play if reliance solely on stamping out is not feasible. Specifically, we  visited DHS’s Plum Island Animal Disease Center on Plum Island, New  York, where we interviewed officials from USDA’s Foreign Animal  Disease Diagnostic Laboratory and the Agricultural Research Service, as  well as DHS officials, about challenges related to FMD vaccination. We  also reviewed agency documents on the topic and interviewed other  officials from USDA, the North American Vaccine Bank, universities,  states, and industry groups about issues related to FMD vaccination.  Further, we interviewed officials from the vaccine company that currently  produces the majority of FMD vaccine available for use in the United  States and a company that has rights to use a modified version of the  FMD virus to produce FMD vaccine in the future.

To determine how USDA identifies, prioritizes, and monitors corrective  actions to mitigate the challenges, we reviewed APHIS and DHS  guidance on evaluation and improvement planning and other agency  documents, observed an FMD preparedness exercise, reviewed after- action reports from 41 FMD preparedness exercises conducted from  2007 through 2018, and interviewed USDA officials. We reviewed  APHIS’s and DHS’s procedures for evaluation and improvement planning  to understand how APHIS is to identify, prioritize, and monitor corrective  actions. To determine whether APHIS was consistently following these  procedures, we observed the preparedness exercise at APHIS’s  Riverdale, Maryland, office; reviewed a preliminary after-action report for  that exercise; and reviewed after-action reports for the 41 other  preparedness exercises. We interviewed APHIS officials about corrective  actions identified in the after-action reports and what steps the agency  has taken to prioritize the actions and monitor their progress. We  reviewed agency documents about these procedures and about actions  USDA has taken and identified but not yet taken to mitigate challenges.  To find examples of corrective actions that USDA has identified and taken  or not yet taken, we reviewed after-action reports for the 41 preparedness  exercises; APHIS’s 2018-2020 training and exercise plan for its veterinary  services emergency preparedness and response unit; and other agency  documents, such as contracts and plans, and interviewed agency  officials. The examples of corrective actions in table 1 are illustrative only  and do not include or represent all of the actions that USDA has  identified. We sent a draft table of examples to APHIS officials and  incorporated their comments as appropriate.

We also reviewed a GAO report on USDA’s management of highly  pathogenic avian influenza (avian influenza) outbreaks; interviewed  agency officials; reviewed USDA after-action reports for avian influenza  outbreaks; and reviewed USDA’s database of related corrective actions to  learn how the agency identifies, prioritizes, and monitors actions to  mitigate challenges for that disease. To assess the overall reliability of  that database to use information from the database in our report, we  reviewed management controls over the information systems that  maintain the data and interviewed USDA officials who manage the  database. We determined that the database was sufficiently reliable to  describe the contents of the database and general status of corrective  actions.

We conducted this performance audit from May 2017 to March 2019 in  accordance with generally accepted government auditing standards.  Those standards require that we plan and perform the audit to obtain  sufficient, appropriate evidence to provide a reasonable basis for our  findings and conclusions based on our audit objectives. We believe that  the evidence obtained provides a reasonable basis for our findings and  conclusions based on our audit objectives.

Appendix II: Comments from U. S. Department of Agriculture

Appendix III: GAO Contact and Staff Acknowledgments

In addition to the contact named above, Nico Sloss (Assistant Director),  Kevin Bray, Emily Christoff, Mary Denigan-Macauley, Christine Feehan,  Jesse Lamarre-Vincent, Cynthia Norris, Anne Rhodes-Kline, and Amber  Sinclair made key contributions to this report. Ross Campbell, Barb El  Osta, Kathryn Godfrey, Hayden Huang, and Dan Royer also made  important contributions to this report.

Foot-and-Mouth Disease: USDA’s Evaluations of Foreign Animal Health  Systems Could Benefit from Better Guidance and Greater Transparency.  GAO-17-373. Washington, D.C.: April 28, 2017.

Avian Influenza: USDA Has Taken Actions to Reduce Risks but Needs a  Plan to Evaluate Its Efforts. GAO-17-360. Washington, D.C.: April 13,  2017.

Emerging Animal Diseases: Actions Needed to Better Position USDA to  Address Future Risks. GAO-16-132. Washington, D.C.: December 15,  2015.

Federal Veterinarians: Efforts Needed to Improve Workforce Planning.  GAO-15-495. Washington, D.C.: May 26, 2015.

Homeland Security: An Overall Strategy Is Needed to Strengthen Disease  Surveillance in Livestock and Poultry. GAO-13-424. Washington, D.C.:  May 21, 2013.

Veterinarian Workforce: Actions Are Needed to Ensure Sufficient  Capacity for Protecting Public and Animal Health. GAO-09-178.  Washington, D.C.: February 4, 2009.

High-Containment Biosafety Laboratories: DHS Lacks Evidence to  Conclude That Foot-and-Mouth Disease Research Can Be Done Safely  on the U.S. Mainland. GAO-08-821T. Washington, D.C.: May 22, 2008.

National Animal Identification System: USDA Needs to Resolve Several  Key Implementation Issues to Achieve Rapid and Effective Disease  Traceback. GAO-07-592. Washington, D.C.: July 6, 2007.

Avian Influenza: USDA Has Taken Important Steps to Prepare for  Outbreaks, but Better Planning Could Improve Response. GAO-07-652.  Washington, D.C.: June 11, 2007.

Homeland Security: Much Is Being Done to Protect Agriculture from a  Terrorist Attack, but Important Challenges Remain. GAO-05-214.  Washington, D.C.: March 8, 2005.

Foot-and-mouth disease is a highly contagious livestock disease (which rarely infects humans). Since 2001, outbreaks abroad have cost billions of dollars. A U.S. outbreak would likely halt exports of all livestock products, and could have serious economic consequences.

USDA has learned lessons from abroad, conducted outbreak exercises, and identified the need for additional preparedness improvements, such as a better process for allocating its limited vaccine supply. However, it has not followed its procedures for prioritizing improvements and many remain incomplete.

We recommended that USDA prioritize and monitor these improvements.