Selected Worldwide Disease Occurrence: Foot-and-Mouth Disease According to the Department of Agriculture, a 2001 outbreak of foot-and-mouth disease in the United Kingdom resulted in the slaughter and disposal of millions of animals and economic losses conservatively estimated at $14.7 billion. Foot-and-mouth disease is a highly contagious viral disease of cloven-hoofed animals such as cattle, swine, and sheep, and does not have human health implications. Homeland security presidential directives (HSPD) have called for HHS, USDA, DHS, and other federal agencies to take action to strengthen biosurveillance, including food and agriculture disease surveillance. For example, HSPD-9: Defense of United States Agriculture and Food, issued in January 2004, directed HHS and USDA, among others, to develop robust, comprehensive, and fully coordinated biosurveillance and monitoring systems for animals, plants, wildlife, food, human health, and water. Further, DHS was to lead, integrate, and coordinate implementation efforts among federal departments and agencies to protect critical infrastructure, including agriculture. HSPD-10: Biodefense for the 21st Century, issued in April 2004, established the four pillars of biodefense: (1) threat awareness, (2) prevention and protection, (3) surveillance and detection, and (4) response and recovery. Pursuant to these presidential directives, as well as federal laws, many federal departments and agencies pursue missions and manage programs that contribute to a national biosurveillance capability. Table 1 describes selected federal departments and agencies with surveillance- related responsibilities. Selected Worldwide Disease Occurrence: Salmonella, United States, 2008 In 2008, a salmonella outbreak occurred in 43 states and the District of Columbia, with 1,500 persons reportedly ill with the outbreak strain. The initial investigations identified tomatoes as the likely source. As the outbreak continued, additional investigations showed much of the outbreak was due to jalapeno and Serrano peppers grown and packed in Mexico and distributed in the United States. According to the Department of Agriculture's Rural Cooperative, the tomato industry sustained an estimated loss of $100 million or more. policies.and National Security Council were merged as the National Security Council Staff, but both councils continue to exist by statute. The Homeland Security Council was maintained as the principal venue for interagency deliberations on issues that affect the security of the homeland, such a biosurveillance. In May 2009, the staff serving the Homeland Security Council We have previously reported that in an era of rapid transit and global trade, the public health and agricultural industries, as well as natural ecosystems including native plants and wildlife, face increased threats of naturally occurring outbreaks of infectious disease and accidental exposure to biological threats. influenza, are known as zoonotic diseases and can be transferred between animals and humans. Influenza pandemics occur when a new influenza virus emerges and spreads around the world, and most people do not have immunity. Although human influenza pandemics have been rare in the United States, they have had devastating effects. For example, as we reported in 2011 and 2013, HHS estimated that the 2009 H1N1 pandemic in the U.S. led to as many as 403,000 hospitalizations and 18,300 deaths from April 2009 to April 2010, and HHS had over $6 billion available for influenza pandemic activities from a 2009 supplemental Some diseases, such as some strains of appropriation. Selected Worldwide Disease Occurrence: Anthrax In 2001, anthrax was intentionally spread through the postal system by sending letters with powder containing anthrax to the U.S. Capitol. Of the 22 infected persons, 5 died. The Environmental Protection Agency spent $27 million for clean up of Capitol Hill and the U.S. Postal Service was appropriated hundreds of millions of dollars to clean up affected facilities. GAO-10-645. Although the White House developed the National Strategy for Biosurveillance in July 2012, this strategy does not include information that identifies resource and investment needs as we previously recommended. In June 2010, we found that there was no integrated approach to help ensure an effective national biosurveillance capability and to provide a framework to help identify and prioritize investments. Without a unifying framework; structure; and an entity with the authority, resources, time, and responsibility for guiding its implementation, we concluded that it would be very difficult to create an integrated approach to building and sustaining a national biosurveillance capability. National and agency strategies note that coordination is important because a national biosurveillance capability relies on the ability of a complex interagency and intergovernmental network to work together and meet an ever-evolving threat. Specifically, we found there was neither a comprehensive national strategy nor a designated focal point with the authority and resources to guide the effort to develop a national biosurveillance capability. We have previously found that developing effective national strategies and establishing a focal point with sufficient responsibility, authority, and resources can help ensure successful implementation of complex interagency and intergovernmental undertakings, such as providing a national biosurveillance capability. We made two recommendations to the White House's Homeland Security Council, which has taken some actions to address them, as shown in table 2. The National Strategy for Biosurveillance also does not address issues we raised related to state and local biosurveillance efforts, and that we previously recommended. In October 2011, we reported that nonfederal capabilities should also be considered in creating a national Because the resources that constitute a biosurveillance strategy.national biosurveillance capability are largely owned by nonfederal entities, a national strategy that considers how to strengthen and leverage nonfederal partners could improve efforts to build and maintain a national biosurveillance capability. Moreover, efforts to build the capability would benefit from a framework that facilitates assessment of nonfederal jurisdictions' baseline capabilities and critical gaps across the entire biosurveillance enterprise. In 2011, we found that although the federal government did provide some resources to help control disease in humans and animals in tribal and insular areas, there were no specific efforts to ensure that states and local agencies can contribute to the national biosurveillance capability. In addition, we noted that the federal government had not conducted a comprehensive assessment of state and local jurisdictions' ability to contribute to a national biosurveillance capability. While the size, variability, and complexity of the biosurveillance enterprise makes an assessment difficult, we concluded that the federal government would lack key information about the baseline status, strengths, weaknesses, and gaps across the biosurveillance enterprise until it conducts an assessment of nonfederal biosurveillance capabilities. We further reported in October 2011 that state and local officials identified common challenges to developing and maintaining their biosurveillance capabilities such as (1) state policies in response to state budget constraints that restricted hiring, travel, and training; (2) obtaining and maintaining resources, such as adequate workforce, equipment, and systems; and (3) the lack of strategic planning and leadership to support long-term investment in crosscutting core capabilities, integrated biosurveillance, and effective partnerships. For example, state and local officials we surveyed had reported facing workforce shortages among skilled professionals--epidemiologists, informaticians, statisticians, laboratory staff, animal-health staff, or animal-disease specialists. Many of the challenges that state and local officials identified were similar to issues we reported regarding biosurveillance at the federal level. We noted that many of the challenges facing the biosurveillance enterprise were complex, inherent to building capabilities that cross traditional boundaries, and not easily resolved. To address these issues, and building on our June 2010 recommendation to develop a national biosurveillance strategy, we called for such a strategy to also address the key challenges we identified in nonfederal biosurveillance, as shown in table 3. As part of the national biosurveillance capability, the maintenance of effective animal and plant surveillance systems is critical to detecting and enhancing the situational awareness of biological events that might disrupt agriculture and food production systems, such as highly pathogenic avian influenza. Although DHS, the White House's Homeland Security Council, and USDA have made efforts to improve the coordination and implementation of federal food and agriculture defense policy, additional actions are needed. In August 2011, we found that there was no centralized coordination to oversee the federal government's overall progress implementing HSPD-9 on the nation's food and agriculture defense policy, responsibilities for which are distributed across several agencies. As we reported in 2011, these federal responsibilities include the development of surveillance and monitoring systems for animal, plant, and wildlife disease, food, public health, and water quality, as well as other responsibilities related to awareness and warning, vulnerability assessment, mitigation strategies, response and recovery, and research and development. Prior to 2011, the White House's Homeland Security Council had conducted some coordinated activities to oversee federal agencies' HSPD-9 implementation by gathering information from agencies about their progress. DHS supported these activities by coordinating agencies' responses to the White House on their progress. However, at the time of our 2011 review, the White House and DHS had discontinued their efforts. Per HSPD-9, DHS is responsible for coordinating agencies' overall HSPD-9 implementation efforts. In addition, the White House's Homeland Security Council was established by executive order in 2001 to ensure the effective development and implementation of homeland security policies, including HSPD-9. Because there was no centralized coordination to oversee agencies' HSPD-9 implementation progress at the time of our 2011 review, it was unclear how effectively or efficiently agencies were using resources in implementing the nation's food and agriculture defense policy, including surveillance efforts. We concluded that without coordinated activities to oversee agencies' implementation efforts, the nation may not be assured that crosscutting agency efforts to protect agriculture and the food supply are well designed and effectively implemented in order to reduce vulnerability to, and the impact of, terrorist attacks, major disasters, and other emergencies. We also reported in August 2011 that USDA's component agencies had taken steps to implement the department's HSPD-9 responsibilities, but USDA did not have a department-wide strategy for implementing its numerous HSPD-9 responsibilities. For example, component agencies had taken steps to implement the four HSPD-9 response and recovery efforts for which USDA has lead responsibility, such as APHIS's development of the National Veterinary Stockpile. However, according to USDA officials, the department assigned HSPD-9 responsibilities to its component agencies based on their statutory authority and expertise and allowed individual agencies to determine their implementation and budget priorities. To address these issues, we made four recommendations to DHS, the White House's Homeland Security Council, and USDA, and each agency generally concurred with its respective recommendations. Since we made these recommendations, in August 2011, these entities have taken some actions to address them, as shown in table 4. We reported in May 2013 that APHIS had developed a new approach for its livestock and poultry surveillance activities, but had not yet integrated these efforts into an overall strategy with goals and performance measures aligned with the nation's larger biosurveillance policy. Under its prior approach, APHIS focused its disease surveillance programs on preventing the introduction of certain foreign animal diseases and monitoring, detecting, and eradicating other reportable diseases already present in domestic herds. Under this previous approach, information about nonreportable diseases, including those that are new or reemerging, was not always captured by the agency's disease surveillance efforts. We reported in 2013 that under its new approach APHIS had begun to broaden its approach by monitoring the overall health of livestock and poultry and using additional sources and types of data to better detect and control new or reemerging diseases. For example, APHIS has been monitoring for the presence of pseudorabies-- a viral swine disease that may cause respiratory illness and death--at slaughter facilities, but under the new approach, it has proposed monitoring these facilities for a range of other diseases as well. Although APHIS had a vision for its new approach, we found that it had not yet integrated that vision into an overall strategy with associated goals and performance measures aligned with the nation's larger biosurveillance efforts. At the time of our 2013 review, APHIS had developed a number of planning documents related to the agency's capabilities for disease surveillance in livestock and poultry, but these documents did not specifically address outcomes the agency seeks to accomplish or have associated performance measures. Moreover, none of APHIS's surveillance plans indicated how they individually or collectively supported national homeland security efforts called for in HSPD-9 or other national policies to defend the nation's food and agricultural systems against terrorist attacks, major disasters, and other emergencies. We concluded that without integrating its new approach to livestock and poultry surveillance activities into an overall strategy with goals and measures aligned with broader national homeland security efforts to detect biological threats, APHIS may not be ideally positioned to support national efforts to address the next threat to animal and human health. To address this issue, we made a recommendation to APHIS, with which APHIS concurred and is taking action to address, as described in table 5. Chairman Johnson, Ranking Member Carper, and members of the committee, this completes our prepared statement. We would be pleased to respond to any questions that you may have at this time. For questions about this statement, please contact Chris Currie at (404) 679-1875 or curriec@gao.gov and Steve D. Morris 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 statement. Individuals making key contributions to this statement include Kathryn Godfrey and Mary Denigan-Macauley (Assistant Directors), Lorraine Ettaro, Elias Harpst, Tracey King, Amanda Kolling, Jan Montgomery, Erin O'Brien, Virginia Vanderlinde, John Vocino, and Brian Wanlass. Key contributors for the previous work that this testimony is based on are listed in each product. This is a work of the U.S. government and is not subject to copyright protection in the United States. The published product may be reproduced and distributed in its entirety without further permission from GAO. However, because this work may contain copyrighted images or other material, permission from the copyright holder may be necessary if you wish to reproduce this material separately.

Summary:
Naturally-occurring infectious disease or the intentional use of a biological agent to inflict harm could have catastrophic consequences. For example, the recent outbreak of naturally-occurring highly pathogenic avian influenza affecting wild birds and poultry in the Midwest and on the Pacific coast presents a serious threat to the economy and trade, and underscores the importance of maintaining effective food and agriculture disease surveillance systems. Biosurveillance aims to detect such events as early as possible and to enhance situational awareness related to human, animal, and plant health. Since 2010, GAO has issued a number of reports that discuss the importance of effectively conducting biosurveillance across the human, animal, and plant domains. This statement discusses prior GAO reports and the status of recommendations related to (1) federal, state, and local biosurveillance efforts, and (2) efforts related to food and agriculture disease surveillance. This testimony is based on previous GAO products issued from 2010 through 2013 related to biosurveillance, along with selected updates conducted from November 2014 through June 2015. For these updates, GAO reviewed agency responses and documents provided in response to its recommendation follow-up efforts, such as the July 2012 National Strategy for Biosurveillance . In June 2010, GAO reported that there was neither a comprehensive national strategy nor a designated focal point with the authority and resources to guide development of a national biosurveillance capability. Further, in October 2011, GAO reported that states and local agencies faced challenges in developing and maintaining their biosurveillance capabilities, such as obtaining resources for an adequate workforce, and that the federal government had not conducted an assessment of state and local jurisdictions' ability to contribute to a national biosurveillance capability. To help ensure the successful implementation of a complex, intergovernmental undertaking, GAO recommended in 2010 that the White House's Homeland Security Council direct the National Security Council Staff to develop a national biosurveillance strategy, and further recommended in 2011 that the strategy consider nonfederal capabilities. The White House issued the National Strategy for Biosurveillance in July 2012, which describes the U.S. government's approach to strengthening biosurveillance. However, the strategy did not fully respond to the challenges GAO identified. For example, it did not establish a framework to prioritize resource investments or address the need to leverage nonfederal resources. The White House was to issue an implementation plan within 120 days of publishing the strategy. GAO has reported that it is possible that the implementation plan could address issues previously identified, such as resource investment prioritization; however, the plan has not been released as of June 2015. In August 2011, GAO reported that there was no centralized coordination to oversee federal agencies' efforts to implement Homeland Security Presidential Directive 9 (HSPD-9) on the nation's food and agriculture defense policy, which includes food and agriculture disease surveillance. GAO also found that the Department of Agriculture (USDA) had no department-wide strategy for implementing its HSPD-9 responsibilities. Therefore, GAO recommended that the National Security Council Staff and the Department of Homeland Security resume their efforts to coordinate and oversee implementation, and that USDA develop a department-wide strategy. In response, the National Security Council Staff began hosting interagency working group meetings, and DHS has worked to develop a report on agencies' HSPD-9 implementation efforts, which officials stated will be finalized by late summer 2015. As of February 2015, USDA had conducted a gap analysis of its HSPD-9 implementation efforts but had not yet developed a department-wide strategy. Further, GAO reported in May 2013 that USDA's Animal and Plant Inspection Service (APHIS) had broadened its previous disease-by-disease surveillance approach to an approach in which the agency monitors the overall health of livestock and poultry, but had not yet integrated this approach into an overall strategy aligned with the nation's larger biosurveillance efforts, such as efforts called for in HSPD-9. GAO recommended that APHIS integrate its new approach into an overall strategy aligned with national homeland security efforts, and develop goals and measures for the new approach. In June 2015, officials stated that APHIS has begun to develop some measures, but noted that resource constraints limit their ability to assess their new approach to disease surveillance. Fully integrating its new approach into an overall strategy aligned with broader homeland security efforts, as GAO recommended, will better position APHIS to support national efforts to address threats to animal and human health.