You are given two reports by the government agency.  

Report 1:
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. 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 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 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. 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 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. 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. 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. 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. 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. 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. 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.

 

 Report 2:
Health care practitioners prescribe opioid medications to treat pain and sometimes for other health problems, such as severe coughing. Opioid medications are available as immediate or extended release and in different forms, such as a pill, liquid, or a patch worn on the skin. Opioids slow down some processes of the body, such as breathing and heartbeat, by binding with certain receptors in the body. Over time, the body becomes tolerant to opioids, which means that larger doses of opioid medications are needed to achieve the same effect. People may use opioids in a manner other than as prescribed—that is, they can be misused. Because opioids are highly addictive substances, they can pose serious risks when they are misused, which can lead to addiction and death. Symptoms of an opioid use disorder include a strong desire for opioids, the inability to control or reduce use, and continued use despite interference with major obligations or social functioning. Another concern associated with prescribed opioids is the potential for diversion for illegal purposes, such as nonmedical use or financial gain. Research has shown that MAT—which combines behavioral therapy and the use of certain medications (methadone, buprenorphine, and naltrexone)—can be more effective in reducing opioid use and increasing retention (i.e., reducing dropouts) compared to abstinence based treatment—that is when patients are treated without medication. Three medications are currently approved by FDA for use in MAT for opioid use disorders—methadone, buprenorphine, and naltrexone. Methadone: Methadone is a full opioid agonist, meaning it binds to and activates opioid receptors to help prevent withdrawal symptoms and reduce drug cravings. It has a long history of use for the treatment of opioid dependence in adults. Methadone suppresses withdrawal symptoms during detoxification therapy, which involves stabilizing patients who are addicted to opioids by withdrawing them in a controlled manner. Methadone also controls the craving for opioids during maintenance therapy, which is ongoing therapy meant to prevent relapse and increase treatment retention. Methadone can be administered to patients as an oral solution or in tablet form. Buprenorphine: Buprenorphine is a partial opioid agonist, meaning it binds to opioid receptors and activates them, but not to the same degree as full opioid agonists. It reduces or eliminates opioid withdrawal symptoms, including drug cravings. It can be used for detoxification treatment and maintenance therapy. It is available for MAT for opioid use disorder in tablet form for sublingual (under the tongue) administration, in film form for sublingual or buccal (inside the cheek) administration, and as a subdermal (under the skin) implant. Naltrexone: Naltrexone is an opioid antagonist, meaning it binds to opioid receptors but does not activate them. It is used for relapse prevention following complete detoxification from opioids. Naltrexone prevents opioid drugs from binding to and activating opioid receptors, thus blocking the euphoria the user would normally feel. It also results in withdrawal symptoms if recent opioid use has occurred. It can be taken daily in an oral tablet form or as a once-monthly injection given in a doctor’s office. Two of the three medications used to treat opioid use disorders— methadone and buprenorphine—are drugs that carry a potential for misuse. Under the Controlled Substances Act (CSA), treatment involving these medications can take place in certain authorized settings: as part of federally regulated OTPs or in other settings, such as a physician’s office, within certain restrictions. OTPs. OTPs provide MAT, including methadone and buprenorphine, for people diagnosed with an opioid use disorder. Methadone may generally only be administered or dispensed within an OTP, as prescriptions for methadone cannot be issued when used for opioid use disorder treatment. Buprenorphine may be administered or dispensed within an OTP, or may also be prescribed by a qualifying practitioner who has received a waiver from SAMHSA. Naltrexone is not a controlled substance and can be used in OTPs and other settings. Office-Based and Other Settings. Under a Drug Addiction Treatment Act of 2000 (DATA 2000) waiver, practitioners may prescribe buprenorphine to up to 30 patients in the first year of their waiver, 100 patients in the second year, and up to 275 patients in the third year. Practitioners at the 275-patient level must meet additional qualifications and requirements. Naltrexone does not have similar restrictions. HHS has implemented five key efforts from 2015 through August 2017 that focus on expanding access to MAT for opioid use disorders. Four of these are grant programs, including programs focused on health centers or primary care practices in rural areas. Targeted Capacity Expansion: Medication Assisted Treatment – Prescription Drug and Opioid Addiction (MAT-PDOA). This grant program is administered by SAMHSA and provides funding to states to increase their capacity to provide MAT and recovery support services to individuals with opioid use disorders. Grant recipients are expected to identify a minimum of two high-risk communities within the state and partner with local government or community- based organizations to address the MAT-related treatment needs in these communities. Among other things, recipients are to use outreach and other engagement activities to increase participation in and access to MAT for diverse populations at risk for opioid use disorders. In August 2015, SAMHSA awarded 3-year grants to 11 states, under which each of the states will receive up to $1 million in each grant year. In September 2016, SAMHSA awarded 11 additional 3-year grants to other states. Total funding is expected to be up to $66 million for all 22 grants. SAMHSA announced the availability of up to 5 additional 3-year grants for fiscal year 2017. Applications for these grants of up to $2 million per year were due in July 2017 and as of August 2017 they had not been awarded. Substance Abuse Service Expansion Supplement to Health Centers. This grant program is administered by HRSA and provides funds for existing health centers to improve and expand their delivery of substance abuse services, including services with a specific focus on MAT for opioid use disorders in underserved populations. Health centers that receive these grants are required to increase the number of patients with health center-funded access to MAT for opioid use or for other substance abuse disorders treatment by adding at least one full-time substance abuse provider and supporting new or enhanced existing substance abuse services. HRSA awarded 2-year grants in March 2016 to 271 health centers. According to HRSA documents, total funding could be up to $200 million for all grants over 2 years. HRSA announced the availability of another set of grants to health centers for fiscal year 2017. Applications for these grants were due in July 2017, and as of August 2017 they had not been awarded. Increasing Access to Medication-Assisted Treatment in Rural Primary Care Practices. This grant program is administered by AHRQ and funds demonstration research projects that aim to expand access to MAT for opioid use disorders in primary care practices in rural areas of the United States. Grant recipients are expected to recruit and engage primary care providers and their practices, provide training, and support physicians and their practices in initiating treatment. The program also identifies and tests strategies for overcoming the challenges associated with implementing MAT in primary care settings and creates training and other resources for implementing MAT. AHRQ awarded these 3-year grants of up to $1 million per year to four recipients—the recipients are teams of state health departments, academic health centers, local community organizations, physicians, and others—with project start dates of September 30, 2016. According to AHRQ documents, total funding is expected to be up to $12 million for the four grants over 3 years. State Targeted Response to the Opioid Crisis Grants (Opioid STR). This grant program is administered by SAMHSA and provides funding to states and others to increase access to treatment services for opioid use disorders, including MAT; reduce unmet treatment needs; and reduce opioid overdose deaths. Grant recipients are expected to implement or expand access to evidence-based practices, particularly the use of MAT, and to report on the number of people who receive opioid use disorder treatment, the number of providers implementing MAT, and the number of providers trained to use MAT. SAMHSA awarded 2-year grants starting in May 2017 to 50 states, the District of Columbia, four U.S. territories and the free associated states of Micronesia and Palau. According to SAMHSA documents, total funding could be up to $970 million for all grants over 2 years. Figure 1 displays the implementation timeframes, the number of grants, and funding levels for the four HHS grant programs related to MAT. As the figure shows, some of these awards were made in fiscal year 2015, while others were made as recently as May 2017. As of August 2017, these efforts were ongoing. In addition to these four grant programs, HHS’s fifth key effort increases treatment capacity by expanding the waivers that practitioners may receive to prescribe buprenorphine. Specifically, SAMHSA issued a regulation that became effective August 8, 2016 increasing the number of patients that eligible practitioners can treat with buprenorphine outside of an OTP (e.g., in an office-based setting). Previously, qualified practitioners could request approval to treat up to 30 patients at a time, and after 1 year the limit could increase to 100 patients at a time upon SAMHSA approval. The new regulation expanded access to MAT by allowing eligible practitioners who have had waivers to prescribe buprenorphine to 100 patients for at least 1 year to request approval to treat up to 275 patients thereafter. Similarly, SAMHSA has implemented provisions of the Comprehensive Addiction and Recovery Act of 2016 (CARA) that expanded the types of practitioners who can receive a waiver to prescribe buprenorphine in an office-based setting to include qualifying nurse practitioners and physician assistants. CARA generally requires that these nurse practitioners and physician assistants complete 24 hours of training to be eligible for a waiver. According to HHS documents, as of early 2017, nurse practitioners and physician assistants who have completed this training could request a waiver from SAMHSA to treat up to 30 patients at a time. In addition to its five key efforts focused specifically on expanding access to MAT for opioid use disorders, HHS has other efforts with broader focuses, such as treating multiple types of substance abuse. While these efforts are not specifically focused on expanding access to MAT for opioid use disorders, they may result in expanded access to MAT. For example, CMS has approved section 1115 Medicaid demonstration projects to allow states to undertake comprehensive reforms of their delivery of substance abuse services, including provisions to enhance the use of MAT for opioid use disorders. In July 2015, CMS issued a state Medicaid Director letter informing states that they may seek approval of section 1115 demonstrations to undertake comprehensive substance use service reforms. According to CMS, all participating states are using the demonstration authority to develop a full continuum of care for individuals with substance abuse disorders, including coverage of short-term residential treatment services not otherwise covered by Medicaid. In addition, FDA has programs to help expedite development and to provide for faster review of marketing applications for certain drugs. According to FDA, it has conducted expedited reviews of Suboxone (buprenorphine and naloxone sublingual film), Vivitrol (extended release naltrexone injection) and Probuphine (buprenorphine subdermal implant). According to some federal officials and other stakeholders that we interviewed, as part of efforts to expand access to MAT for opioid use disorder, steps are being taken to prevent the possibility that the MAT medications could, in some cases, be diverted for illicit use, misuse, or for purposes not intended by a prescriber. For example, OTPs and practitioners who request and receive a waiver to prescribe buprenorphine to treat up to 275 patients outside of an OTP setting are required under federal regulations to maintain a diversion control plan. In addition, the MAT-PDOA grant program explicitly requires grant recipients to implement a diversion control plan, though the other grant programs do not have similar additional requirements. (See appendix I for an overview of the diversion control plan requirements for OTPs and the practitioners who prescribe buprenorphine outside of an OTP.) The 2016 Surgeon General’s report on Alcohol, Drugs, and Health noted that decades of research have shown that the benefits of MAT greatly outweigh the risks associated with diversion, and that withholding these medications greatly increases the risk of relapse to illicit opioid use and overdose death. HHS officials told us that as of August 2017, the department is in the process of finalizing its approach for evaluating the implementation of its agencies’ collective efforts to address the opioid epidemic that were undertaken as part of the HHS Opioid Initiative and will continue under the new administration’s Opioid Strategy. HHS officials provided a draft of the evaluation’s schedule. According to the officials, the evaluation will include, but not be limited to, efforts to expand access to MAT. In September 2016, HHS awarded a 2-year contract to Research Triangle Institute International (RTI) to evaluate HHS agencies’ collective efforts. HHS officials told us that they are still working with RTI to finalize the evaluation approach given new leadership priorities. Specifically, in April 2017, the new Secretary of HHS announced a revised strategy for addressing the opioid epidemic that will continue to address access to MAT for opioid use disorders but also include additional priority areas. According to HHS officials, to be responsive to the new priorities, the evaluation will focus initially on whether HHS’s efforts have been implemented as intended, and officials expect the evaluation to also provide information on any challenges HHS has faced in implementing these efforts. According to HHS officials, while the evaluation of MAT expansion efforts will use information from several sources, they have not yet determined exactly which information will be used or how it will be used. This information may include, for example, results from a separate, planned evaluation of one of the grant programs, Opioid STR, as well as other information HHS agencies collect as part of their ongoing monitoring efforts for each of their individual MAT grant programs. While the reporting requirements vary across the four MAT grant programs, the grantees provide HHS with information related to expanding access to MAT. Specifically, Targeted Capacity Expansion: Medication Assisted Treatment – Prescription Drug and Opioid Addiction (MAT-PDOA): Every 6 months, grant recipients are expected to submit progress reports to SAMHSA on the planned and actual number of patients treated, as well as information on other performance measures. Increasing Access to Medication-Assisted Treatment in Rural Primary Care Practices: Grant recipients are expected to submit quarterly progress reports to AHRQ with various information, such as information on the number of physicians who have been certified to prescribe buprenorphine and the number of primary care practices successfully initiating the delivery of MAT services as a result of the grant project. Substance Abuse Service Expansion Supplement to Health Centers: Health centers that received these grants were expected to submit quarterly progress reports to HRSA through the second quarter of 2017 on the number of physicians who have obtained a DATA 2000 waiver and the number of patients who received MAT from these physicians. Health centers must now report these data elements in their annual performance reporting along with information on the number of certified nurse practitioners and physician assistants who have received a DATA 2000 waiver. State Targeted Response to the Opioid Crisis Grants (Opioid STR): Every 6 months, grant recipients are expected to submit progress reports to SAMHSA on the number of individuals who receive opioid use disorder treatment, the number who receive opioid use disorder recovery services, and the number of providers implementing MAT, among other measures. While HHS’s evaluation will focus on whether HHS’s efforts have been implemented as intended, officials told us that in the future an evaluation may also focus on the effectiveness of these efforts, including the effectiveness of efforts to expand access to MAT. Doing so would be consistent with federal standards for internal control, which call for agencies to evaluate results. HHS has some of the information that could be used in a future evaluation of the effectiveness of its efforts to expand access to MAT. In particular, an HHS document describing the department’s fiscal year 2016 – 2017 goals identifies expanding MAT access as an important strategy for the success of HHS’s longer-term goal of reducing opioid use disorders and opioid overdoses. In addition, HHS has identified three potential ways to measure access to MAT: the number of prescriptions for MAT medications, the treatment capacity of practitioners who are authorized to prescribe buprenorphine for opioid use disorders through a DATA 2000 waiver, and the treatment capacity of OTPs certified to administer methadone and other medications. In addition, HHS has data that could be useful for tracking progress in these areas (see table 1). However, HHS has not adopted specific performance measures with targets specifying the magnitude of the increases HHS hopes to achieve through its efforts to expand access to MAT, and by when. For example, HHS has not established a long-term target specifying the percentage increase in the number of prescriptions for buprenorphine HHS would like to achieve, which would help to show whether efforts by HHS and others are resulting in sufficient progress in increasing prescriptions for this MAT medication. HHS has also not chosen a specific method of measuring treatment capacity or established targets associated with it, which would help to show whether a sufficient number of providers are becoming available to evaluate and treat patients who may benefit from MAT. Without specifying these performance measures and associated targets, HHS will not have an effective means to determine whether its efforts are helping to expand access to MAT. The lack of such performance measures with associated targets is inconsistent with federal internal control standards that specify that management should define objectives and evaluate results. According to these standards, using performance information such as performance measures can help agencies monitor results and determine progress in meeting program goals. In the context of HHS’s efforts to expand access to MAT, establishing appropriate performance measures with associated targets would allow HHS to determine whether its efforts are making sufficient progress or whether they need to be improved. Gauging this progress is particularly important, given the large nationwide MAT treatment gap identified in 2015 between the total number of individuals who could benefit from MAT and the limited number who can access it based on provider availability. This gap was estimated at nearly 1 million people as of 2012, and according to HHS officials and other stakeholders, lack of providers continues to be a challenge. Until HHS establishes performance measures with associated targets for the factors related to access to MAT, the department will be unable to evaluate its progress expanding access to MAT for opioid use disorders. In addition, as of August 2017, HHS has not finalized its approach for the planned evaluation activities, including timeframes. ASPE officials said that timeframes for a finalized evaluation approach had not been established because they were still working with RTI to finalize the evaluation approach given the new leadership priorities. When we spoke with the officials, they provided us with a draft evaluation schedule that covered the contract period ending September 2018. As of October 2017, HHS had not provided a finalized evaluation approach or schedule. Federal internal controls call for management to establish and operate monitoring activities and evaluate results. Without an implementation timeframe for the evaluation’s activities, HHS increases the risk that its evaluation of its agencies’ efforts will not be completed as expeditiously as possible, including an evaluation of HHS’s efforts to expand access to MAT. Officials from selected state health departments and behavioral health agencies, private health insurers, and national associations reported using several different efforts to help expand patients’ access to MAT for opioid use disorders. All of the stakeholders we interviewed reported conducting outreach efforts to communicate information about the importance of MAT and how to access it, or providing training to educate providers on prescribing MAT medications. Efforts by states. State health officials we spoke to described several planned or ongoing efforts to expand access to MAT, some of which are supported by federal funding, including federal grant programs. Officials from all five selected states told us that they are offering outreach to and training for providers to help expand access to MAT. For example, several state officials told us that they are promoting training to (1) encourage physicians to obtain authorization (DATA 2000 waivers) to prescribe buprenorphine and (2) encourage physicians with waivers to treat patients up to their patient limit or to request a higher patient limit. According to the stakeholders, all five selected states have implemented or are planning to implement a health care delivery model or approach that will expand access to MAT. Specifically, these models or approaches focus on integrating the use of MAT into primary care settings. For example, health officials from three states described use of a hub-and-spoke model. This model generally involves centralized intake and initial management of patients at a “hub” (e.g., an OTP) and then connecting these patients to community providers at “spokes” (e.g., primary care clinics) for ongoing care, with ongoing support provided by the hub as needed. Additionally, officials from two states described offering remote MAT-related consultations through telehealth that connects patients in rural areas with addiction specialists. According to a 2017 Healthcare Fraud Prevention and Partnership whitepaper, telehealth expands the reach of the addiction professional workforce and the existing pool of MAT providers, and it supports remote forms of behavioral therapy to make trained professionals more accessible to those in underserved or isolated communities. Officials from three states described focusing their MAT expansion efforts in various settings, such as in the criminal justice setting and emergency room departments. State health officials from four of the five states told us that programs in their states are using peer specialists (individuals who have successfully recovered from substance abuse disorders) in emergency rooms and other settings to engage with addicted patients and refer them to addiction specialists or behavioral health counselors. Officials from the selected states said that some of these and other efforts are funded through federal sources, such as MAT expansion grants awarded by SAMHSA, or with state funds to the extent they are available. Efforts by private health insurers. Officials from private health insurers reported that they are expanding access to MAT through outreach or training for providers and through the following three efforts: Eliminating the need for prior authorization to prescribe MAT medications. Officials from three insurers reported removing prior authorization requirements for MAT medications, thereby making it easier for patients to access needed MAT medications more readily, rather than undergoing a waiting period for approval to receive the medications. Other private health insurers told us that they continue to require prior authorization, intended for safety reasons and to reduce drug misuse, and officials from one insurer told us that they will allow a patient to access a limited amount of MAT medications for a period of 24 to 72 hours while making a determination about the appropriate treatment services for the patient. Modifying health benefit coverage. Officials from one private health insurance plan told us that the company is redesigning the benefit coverage for methadone and has removed member copays. This effort is intended to make MAT medications more affordable and allow members who are not able to use buprenorphine to have an alternative, such as methadone, that is not cost-prohibitive. Incentivizing providers and health insurance plan members to use MAT. Officials from four private health insurance plans described plans to offer incentives to providers or patients to use MAT. For example, officials from three health plans stated that they are offering alternative payment models or paying higher rates to providers that offer MAT, and another private health insurer is offering incentives to its members who are enrolled in behavioral health programs that provide access to MAT. Efforts by national associations. Officials we interviewed from the national associations—including the American Society of Addiction Medicine, the National Governors Association, and the Association of State and Territorial Health Officials—told us that they are helping to expand access to MAT through outreach and training for their members and by developing tools and resource guides for their members. An official from one association told us that it shares federal grant announcements, including those that are focused on expanding access to MAT, with its members. Officials from another association said it provides training to providers on how to appropriately prescribe MAT medications. In addition, officials from one association told us that they developed an opioid-related road map that identifies examples of strategies—including MAT—that state policymakers can use in their ongoing efforts to address the opioid epidemic. Examples of strategies include reducing the stigma associated with MAT through educating the public and potential providers. Another strategy in the road map is changing payment policies to expand access to MAT services, such as ensuring that Medicaid and other state health programs adequately cover all MAT medications and behavioral interventions and encouraging or requiring commercial health plans to adopt similar policies. HHS funds grant programs and has taken other steps to expand access to MAT, which has been shown to be effective in reducing the prevalence of opioid use disorders and with them, the likelihood of drug overdoses. HHS’s Opioid Initiative began in 2015, and the grants that support it are ongoing, so it is likely too early to determine how effective HHS’s efforts have been in expanding access to MAT and in meeting HHS’s other priorities related to addressing the opioid epidemic. According to HHS, access to MAT can be measured in terms of the number of prescriptions for MAT and by the treatment capacities of OTPs and practitioners who are authorized to prescribe buprenorphine. Our review suggests, however, that HHS may not be ready to perform this evaluation. While HHS told us that it may evaluate the effectiveness of its efforts in the future, the department has not established performance measures with targets that would specify the results that HHS hopes to achieve through its efforts, and by when. Furthermore, HHS has not established timeframes for the activities that will make up its planned evaluation of whether HHS’s efforts have been implemented as intended. Without performance measures with targets and evaluation timeframes, HHS increases the risk that the evaluation will not be completed in a timely manner or that HHS will not know whether its MAT- related efforts are successful or whether new approaches are needed. The evaluation is particularly important, given the hundreds of millions of dollars HHS has invested in its MAT-related grant programs. We are making the following two recommendations to HHS. The Assistant Secretary for Planning and Evaluation should establish performance measures with targets related to expanding access to MAT for opioid use disorders. (Recommendation 1) The Assistant Secretary for Planning and Evaluation should establish timeframes in its evaluation approach that specify when its evaluation of efforts to expand access to MAT will be implemented and completed. (Recommendation 2) We provided a draft of this report to HHS for review, and HHS provided written comments, which are reprinted in appendix II. HHS also provided technical comments, which we incorporated as appropriate. In its written comments, HHS concurred with both of our recommendations. Specifically, for our first recommendation to establish performance measures with targets related to expanding access to MAT for opioid use disorders, HHS stated that developing such measures is appropriate and that the department will continue to work to develop robust performance measures, including measures related to MAT, as part of its overall Opioid Strategy, which includes the department’s most recent efforts to address the opioid epidemic. For our second recommendation to establish timeframes in its evaluation approach that specify when its evaluation of efforts to expand access to MAT will be implemented and completed, HHS agreed that timeframes are important to any evaluation. HHS noted that its evaluation is being conducted under a 2-year contract that is scheduled to end in September 2018. HHS has also provided us with a draft evaluation schedule. We clarified in our report, however, that HHS has not yet provided a finalized approach for the planned evaluation or a finalized schedule establishing timeframes for the activities that will make up the evaluation. Until it finalizes its evaluation approach and establishes related timeframes, HHS increases the risk that it will not complete its planned evaluation by September 2018. We are sending copies of this report to the HHS, and appropriate congressional committees. In addition, the report will be available at no charge on the GAO website at http://www.gao.gov. If you or your staff have questions about this report, please contact me at (202) 512-7114 or curdae@gao.gov. Contact points for our Offices of Congressional Relations and Public Affairs may be found on the last page of this report. Major contributors to this report are listed in appendix III. According to the Department of Health and Human Services, a diversion control plan is a set of documented procedures intended to reduce the possibility that controlled substances will be transferred or used illicitly. Opioid treatment programs (OTPs) and practitioners who prescribe buprenorphine at the highest patient level through a Drug Addiction Treatment Act of 2000 (DATA 2000) waiver are required to have these plans. OTPs are programs that may administer or dispense medication- assisted treatment (MAT) for people diagnosed with an opioid use disorder, including the use of methadone and buprenorphine. In addition, under a DATA 2000 waiver, practitioners may prescribe buprenorphine for patients, up to a 30-, 100-, or 275 patient limit. An OTP must maintain a current diversion control plan that contains specific measures to reduce the possibility of diversion of controlled substances from legitimate treatment use. Per federal guidelines, the goal of the diversion control plan is to reduce the scope and significance of diversion and its impact on communities. The guidelines state that each OTP’s diversion control plan should make every effort to balance diversion control against the therapeutic needs of the individual patient. They also state that diversion control plans should address at least four general areas of concern: program environment, dosing and take-home medication, prevention of multiple program enrollment, and prescription medication misuse. The guidelines include details about each of these areas: Program environment: Diversion in the program environment can be deterred and detected by regular surveillance and the monitoring of areas in and around the program, where opportunities for diversion may exist. A visible human presence at a program’s location gives community members the opportunity to approach staff with concerns and communicates the program’s commitment to assuring a safe environment and a positive impact on the surrounding community. Dosing and take-home medication: In the area of dosing and take- home medication, diversion control encompasses careful control of inventory, attentive patient dosing, and close supervision of take- home medication. Observing a patient take his or her dose and having each of them drink and speak after dosing are fundamental components of diversion control. Take-home dosing should be provided with careful attention to regulatory compliance and the therapeutic benefit and safety these regulations are meant to promote. Prevention of multiple program enrollment: Reasonable measures should be taken to prevent patients from enrolling in treatment provided by more than one clinic or individual practitioner. An OTP, after obtaining patient consent, may contact other OTPs within a reasonable geographic distance (100 miles) to verify that a patient is not enrolled in another OTP. Misuse of prescription medication: The misuse of prescription medication has become an area of great concern nationally and impacts diversion control planning at OTPs. All OTP physicians and other healthcare providers, as permitted, should register to use their respective state’s prescription drug monitoring program (PDMP) and query it for each newly admitted patient prior to initiating dosing. The PDMP should be checked periodically (for example, quarterly) through the course of each individual’s treatment and, in particular, before ordering take-home doses as well as at other important clinical decision points. SAMHSA’s best-practice guidelines for using buprenorphine for treating opioid use disorders include multiple references to diversion, including monitoring for diversion, storage of this medication to minimize diversion, and use of formulations that may be less likely to be diverted. Specifically, the best practices state that, when possible, practitioners should use the combination buprenorphine/naloxone product, which increases safety and decreases the likelihood of diversion and misuse. Further, physicians who request and receive a waiver to prescribe buprenorphine to treat up to 275 patients outside of an OTP are required to have a diversion control plan. According to an HHS official, as of July 13, 2017, roughly 3,330 of the over 39,000 practitioners with a waiver had a 275-patient limit waiver. The majority of these practitioners, just over 27,000, have a 30-patient limit. According to SAMHSA guidance, the diversion plan should contain specific measures to reduce the possibility of diversion of buprenorphine from legitimate treatment use and should assign specific responsibilities of the medical and administrative staff of the practice setting for carrying out these measures. Further, the guidance states that the plan should address how: the environment at the practice setting can prevent onsite diversion; to prevent diversion with regard to dosing and take-home medication; and to prevent patients from receiving a prescription from more than one practitioner and later diverting some of the prescribed medication. Elizabeth H. Curda, Director, (202) 512-7114 or curdae@gao.gov. In addition to the contact name above, Will Simerl, Assistant Director; Natalie Herzog, Analyst-in-Charge; La Sherri Bush; and Emily Wilson made key contributions to this report. Also contributing were Muriel Brown, Krister Friday, Sandra George, and Christina Ritchie.

Question: Write a one-page summary of the report 1.

Answer: 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.