Biosurveillance: Additional Planning, Oversight, and Coordination Needed to Enhance National Capability
Published: 2015-07-08T00:00:00

Fast Facts:

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

section_title: Letter
paragraphs: A catastrophic biological event, such as a naturally occurring pandemic or  a terrorist attack with a weapon of mass destruction, could cause  thousands of casualties, weaken the economy, and threaten national  security. Biosurveillance aims to detect such events as early as possible  and to enhance situational awareness and decision making by gathering,  integrating, interpreting, and communicating essential information related  to all-hazards threats or disease activity affecting human, animal, or plant  health. The recent outbreak of highly pathogenic avian influenza in the  Midwest and on the Pacific coast underscores the importance of  maintaining effective animal and plant surveillance systems within the  broader context of biosurveillance, as the disruption of the agriculture or  food production systems can present a serious threat to the national  economy, trade, and human health. Although the current strain is only  affecting birds at this time, prior influenza strains have had devastating  effects on humans. For example, as we reported in 2011, the Department  of Health and Human Service (HHS) estimated that there were as many  as 89 million U.S. cases of H1N1 influenza from April 2009 to April 2010.
Although USDA’s Food Safety and Inspection Service is responsible for ensuring the  safety of meat, poultry, and processed egg products, HHS’s Food and Drug Administration  is responsible for ensuring the safety of virtually all other food. For more information on  efforts needed to improve federal oversight of food safety, see GAO, High-Risk Series: An  Update, GAO-15-290 (Washington, D.C.: Feb. 11, 2015).
Select Worldwide Disease Occurrence:  Avian Influenza  According to the Department of Agriculture,  since mid-December 2014, there have been  several ongoing highly pathogenic avian  influenza incidents along the Pacific, Central,  and Mississippi Flyways, impacting about 50  million wild birds and poultry. The Centers for  Disease Control and Prevention considers the  risk to people from the current outbreak to be  low and no human infections have been  detected as of June 2015. However, similar  viruses have infected people. For example,  beginning in the early 2000s, an outbreak of  avian influenza spread from China to nearly  60 countries, reaching a peak in 2006. Nearly  500 human cases were reported for this  outbreak, with almost 300 fatalities. The  outbreak also resulted in the death and  destruction of millions of wild and domestic  birds throughout Asia, Europe, Africa, and the  Middle East. respond to biological events in order to minimize human and economic  losses. The responsibility and capacity for collecting most biosurveillance  information and carrying out most health-monitoring activities reside  within state and local jurisdictions or with private sector entities—such as  hospitals and other private health care providers.
Since 2010, we have issued a number of reports that discussed the  importance of conducting biosurveillance across the human, animal, and  plant domains. This statement describes the status of our prior  recommendations related to (1) federal, state, and local biosurveillance  efforts, and (2) efforts related to food and agriculture disease surveillance.  This statement is based on GAO’s prior work issued from June 2010  through May 2013 on various biosurveillance efforts, along with selected  updates conducted from November 2014 through June 2015. To conduct  our prior work, we reviewed relevant presidential directives, laws,  regulations, policies, and strategic plans; surveyed states; and  interviewed federal, state, and industry officials, among others. More  information on our scope and methodology can be found in each of the  reports cited throughout this statement. To conduct our updates, we  reviewed agency responses and documents provided in response to our  recommendation follow-up efforts, such as the July 2012 National  Strategy for Biosurveillance.
The work upon which this testimony is based was conducted 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.
subsections: section_title: Background
paragraphs: 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.
section_title: The White House Has Developed a National Biosurveillance Strategy, but More Action Is Needed to Enhance Federal and Nonfederal Capabilities
subsections: section_title: The National Biosurveillance Strategy Does Not Yet Identify Resource and Investment Needs
paragraphs: 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.
section_title: The National Biosurveillance Strategy Does Not Address Key Challenges for Nonfederal Efforts or the Need to Leverage Nonfederal Resources
paragraphs: 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.
section_title: More Oversight and Coordination Are Needed to Ensure That Federal Food and Agriculture Surveillance Efforts Align with National Policy
subsections: section_title: Federal Oversight and Coordination of the Nation’s Food and Agriculture Defense Policy Could Be Enhanced
paragraphs: 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.
section_title: APHIS Developed a New Approach for Livestock and Poultry Surveillance, but Has Not Integrated These Efforts into an Overall Strategy with Performance Measures
paragraphs: 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.
section_title: GAO Contact and Staff Acknowledgments
paragraphs: 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.
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