Biodefense: The Nation Faces Multiple Challenges in Building and Maintaining Biodefense and Biosurveillance
Released: 2016-04-14T00:00:00


Highlights: section_title: Why GAO Did This Study
paragraphs: The nation's biodefense enterprise is the whole combination of systems at every level of government and the private sector that can contribute to protecting the nation and its citizens from potentially catastrophic effects of a biological event. It is composed of a complex collection of resources, programs, and initiatives, designed for different purposes and dedicated to mitigating various risks, both natural and intentional.

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. Also, threats of bioterrorism, such as anthrax attacks, highlight the continued need for biosurveillance systems that provide early detection and warning about biological threats to humans.

This statement summarizes GAO's work on challenges to building and maintaining the nation's biodefense and biosurveillance. This statement is based on GAO work issued from December 2009 through March 2016 on various biodefense and biosurveillance efforts. GAO also reviewed the 2015 report of the Blue Ribbon Study Panel on Biodefense for updates, but has not independently assessed the entirety of the conclusions, recommendations or methods. To conduct the prior work, GAO reviewed relevant laws, presidential directives, policies, strategic plans, and other reports; surveyed states; and interviewed federal, state, and industry officials, among others.

section_title: What GAO Found
paragraphs: The biodefense enterprise is fragmented and does not have strategic oversight to promote efficiency and accountability. Specifically, the biodefense enterprise lacks institutionalized leadership enterprise-wide to provide strategic oversight and coordination. In 2011, GAO reported, there are more than two dozen presidentially appointed individuals with biodefense responsibilities and numerous federal agencies with mission responsibilities for supporting biodefense activities, but no individual or entity with responsibility for overseeing the entire biodefense enterprise. In 2011, GAO reported that the Homeland Security Council (HSC) should consider establishing a focal point for federal biodefense coordination. In December 2014, National Security Council (NSC) staff, which supports the HSC, told GAO that two of its directorates work together as the focal point for federal biodefense efforts. This is an important step in promoting a comprehensive and coordinated approach to biodefense, but strategic leadership issues persist. In October 2015, a report by the Blue Ribbon Study Panel on Biodefense stated strategic leadership issues persist and called for a focal point to provide strategic leadership, noting that elevating authority above the agency-level can help overcome the challenges faced by the biodefense enterprise. The Study Panel found that White House councils and offices generally only become involved when a specific biodefense issue affects a prominent ongoing responsibility—a method which is not consistent with our call for a strategic approach.

In 2011, GAO also reported that while some high-level biodefense strategies have been developed, there is no broad, integrated national strategy that encompasses all stakeholders with biodefense responsibilities that can be used to guide the systematic identification of risk; assess resources needed to address those risks; and prioritize and allocate investment across the entire biodefense enterprise. GAO reported that the overarching biodefense enterprise would benefit from strategic oversight mechanisms, including a national strategy, to help ensure efficient, effective, and accountable results, and suggested the HSC take action. However, as of February 2016, such a strategy had not been developed.

Biosurveillance, an aspect of biodefense, also faces key challenges at all levels of government that transcend what any one agency can address on its own, and our more recent and ongoing work continues to highlight these challenges. In 2010, GAO recommended the HSC establish a focal point to lead the development of a national biosurveillance strategy that clarifies roles and responsibilities, provides goals and performance measures, and identifies resource and investment needs, among other elements. However, the recommendations have not been fully implemented. Since 2009 GAO's has also identified challenges with specific biosurveillance capabilities. Specifically, GAO has identified biosurveillance capability challenges with, among other topics, (1) state and local public heath capabilities, (2) animal health surveillance capabilities, and (3) two Department of Homeland Security biosurveillance efforts—the National Biosurveillance Integration Center (NBIC) and the BioWatch Program (which aims to provide early indication of an aerosolized biological weapon attack). However, not all recommendations have been implemented.

section_title: Letter
paragraphs: I am pleased to be here today to discuss our work on defending the  nation against biological threats. Biodefense includes measures to  prevent, detect, respond to, and recover from harm or damage caused by  microorganisms or biological toxins to humans, animals, or the food  supply. According to Homeland Security Presidential Directive 10 (HSPD- 10), published in April 2004, successful implementation of the nation’s  biodefense enterprise requires optimizing critical cross-cutting functions  such as information management and communications, research and  development, and acquisition. Within biodefense, biosurveillance, as  defined by the July 2012 National Strategy for Biosurveillance, is the  ongoing process of gathering, integrating, interpreting, and  communicating essential information related to all-hazards threats or  disease activity affecting human, animal, or plant health, for the purpose  of (1) achieving early detection and warning, (2) contributing to overall  situational awareness of the health aspects of the incident, and (3)  enabling better decision making at all levels.

Threats of bioterrorism, such as anthrax attacks, and high-profile disease  outbreaks, such as Ebola in West Africa and emerging arboviruses like  chikungunya and Zika in the Americas, highlight the continued need for  systems that provide early detection and warning about biological threats  to humans. Additionally, recent outbreaks of highly pathogenic avian  influenza in domestic poultry and wild birds in 21 Midwestern and  Western states in 2014, 2015, and 2016 underscore the importance of  maintaining effective surveillance systems within the broader context of  biosurveillance (to include plant and animal). The disruption of the  agriculture or food production systems can present a serious threat to the  national economy, trade, and human health. Numerous federal agencies,  encompassing much of the federal government, have mission  responsibilities for supporting biodefense and biosurveillance activities.

Over the past 15 years, we have reported that complex interagency and  intergovernmental efforts can benefit from developing a national strategy,  and that interagency and intergovernmental activities can benefit from the  leadership of a single entity with sufficient time, responsibility, authority,  and resources needed to provide assurance that the federal programs are  well coordinated, and that gaps and duplication in capabilities are  avoided. We also have an ongoing body of biosurveillance work  spanning more than a decade in which we have examined specific  surveillance programs and activities carried out by the Department of  Homeland Security (DHS); the Departments of Health and Human  Services (HHS); and Agriculture (USDA); and several other federal  departments and agencies. We have identified broad, cross-cutting  issues in leadership, coordination, and collaboration that arise from  working across the complex interagency, intergovernmental, and  intersectoral biosurveillance enterprise.

This statement describes a range of historical and present challenges to  building and maintaining the nation’s biodefense and biosurveillance. This  statement is based on our prior work issued from December 2009 through  March 2016 on various biodefense and biosurveillance efforts. We also  reviewed the 2015 report of the Blue Ribbon Study Panel on Biodefense  for selected updates. The work upon which this statement 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. To conduct our prior work,  we reviewed reports from the bipartisan Commission on the Prevention of  Weapons of Mass Destruction Proliferation and Terrorism (WMD Center),  relevant presidential directives, laws, regulations, policies, strategic plans,  and other reports; 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.
subsections: section_title: Background
subsections: section_title: The Biodefense Enterprise
paragraphs: Biological threats that could result in catastrophic consequences exist in  many forms and arise from multiple sources. For example, several known  biological agents could be made into aerosolized weapons and  intentionally released in a transportation hub or other populated urban  setting, introduced into the agricultural infrastructure and food supply, or  used to contaminate the water supply. Concerned with the threat of  bioterrorism, in 2004, the White House released HSPD-10, which outlines  the structure of the biodefense enterprise and discusses various federal  efforts and responsibilities that help to support it. The biodefense  enterprise is the whole combination of systems at every level of  government and the private sector that can contribute to protecting the  nation and its citizens from potentially catastrophic effects of a biological  event. It is composed of a complex collection of federal, state, local, tribal,  territorial, and private resources, programs, and initiatives, designed for  different purposes and dedicated to mitigating various risks, both natural  and intentional.

Biodefense is organized into four pillars—threat awareness, prevention  and protection, surveillance and detection, and response and recovery—  and multiple federal agencies have biodefense responsibilities within the  pillars. Each of these pillars comprise numerous activities—such as  controlling access to dangerous biological agents used in research—that  generally require coordination across federal departments as well as with  state, local, and international governments, and the private sector.  Protecting humans, animals, plants, air, soil, water, and critical  infrastructure from potentially catastrophic effects of intentional or natural  biological events entails numerous activities carried out within and among  multiple federal agencies and their nonfederal partners (see fig. 1).

section_title: Biosurveillance Threats and Responsibilities
paragraphs: Emerging infectious diseases represent an ongoing threat to the health  and livelihoods of people and animals worldwide. Many advances in  medical research and treatments have been made during the last century,  but infectious diseases are nevertheless a leading cause of death  worldwide. In addition to causing nearly one in five human deaths  worldwide, infectious diseases impose a heavy societal and economic  burden on individuals, families, communities, and countries. Infectious  diseases are a continuous threat for reasons that include: (1)  emergence—at times rapid—of new infectious diseases; (2) re- emergence of previously-known infectious diseases; and (3) persistence  of intractable infectious diseases.

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.  According to the World Health Organization, infectious diseases are not  only spreading faster, they also appear to be emerging more quickly than  ever before. The ongoing outbreak of Zika virus in the Americas has  heightened travel-related concerns regarding the spread of the virus. As  of March 23, 2016, 273 cases of continental U.S. travel-associated Zika  virus disease have been reported, according to Centers for Disease  Control and Prevention (CDC). Figure 2 shows passenger arrivals from  five regions of the world and the top five airports receiving passengers  whose travel originated from each of these regions in 2014.

According to the World Health Organization, about 75 percent of the new  diseases that have affected humans in recent years are zoonotic and  have been caused by pathogens originating from an animal. These  emerging and reemerging diseases transmit between animals—including  domestic animals and wildlife—and humans. Many of these diseases  have the potential to spread through various means over long distances  and to become global problems. In some cases, disease transmission is  direct, in others the animals act as intermediate or accidental hosts, while  in others transmission occurs, for example, via mosquitoes or ticks.  Examples of emerging and zoonotic diseases include: Zika, chikungunya,  and dengue viruses, West Nile virus, H1N1 (swine) influenza, severe  acute respiratory syndrome (SARS), avian influenza, and rabies. Habitat  loss and human encroachment on rural and wildlife environments are  bringing populations of humans and animals, both farmed and wild, into  closer and more-frequent contact. Increasingly, wildlife are involved in the  transmission of diseases to people, pets, and livestock, and managing  wildlife transmitters is an integral part of efforts to control the spread of  zoonotic diseases. Diseases among wildlife can also provide early  warnings of environmental damage, bioterrorism, and other risks to   human health. Finally, potential bioterrorism threats also include the use  of zoonotic diseases as weapons of mass destruction, such as anthrax,  plague, tularemia, and brucellosis.

Transmission  and detection of Zika,  chikungunya, and dengue viruses Zika, chikungunya, and dengue viruses are  all spread by the Aedes aegypti mosquito,  pictured below. These mosquitoes typically  lay eggs in and near standing water in  containers like buckets, bowls, animal dishes,  flower pots, and vases. They prefer to bite  people, and live both indoors and outdoors.  Mosquitoes that spread dengue,  chikungunya, and Zika are aggressive  daytime biters, but also bite at night.  Mosquitoes can become infected when they  feed on a person already infected with the  virus.  Diagnosing Zika virus infection is complicated  because it is difficult to differentiate it from  other similar diseases, such as dengue or  yellow fever, and some tests for Zika virus  antibodies suffer from cross-reactivity with  antibodies to similar viruses. For example, a  person previously infected with another  flavivirus such as dengue could be falsely  identified as also having been exposed to the  Zika virus (and vice-versa).

Numerous federal, state, local, and private sector entities have roles and  responsibilities for monitoring for pathogens in human, animal, plant,  food, and the environment. Federal departments, such as the HHS,  USDA, DHS, and the Department of Interior, play leading biosurveillance  roles for certain domains such as human and animal health, food, and air,  but they also rely on support from state and local authorities or partner  with other federal agencies. In other cases federal departments or  agencies play supporting roles. Officials at all levels of government, as  well as Homeland Security Presidential Directive-21’s (HSPD-21) vision  of a national biosurveillance capability, acknowledge that state and local  capabilities are at the heart of the biosurveillance enterprise. According  to federal, state, and local officials, early detection of potentially serious  disease indications nearly always occurs first at the local level, making  the personnel, training, systems, and equipment that support detection at  the state and local level a cornerstone of our nation’s biodefense posture.  While there is variation in organization and structure among public-health,  animal-health, and wildlife functions at the state, tribal, local, and insular  levels they all share in the nation’s biosurveillance responsibility.  Some  of the nonfederal partners with key responsibilities in the biosurveillance  enterprise are presented in table 1.

section_title: Independent Reports on Issues Facing the Biodefense Enterprise
paragraphs: Bipartisan and independent commissions have identified a range of  issues facing the biodefense enterprise, many of which mirror our  findings. In October 2011, the WMD Center reported its assessment of  various capabilities within the U.S. biodefense enterprise in which a team  of leading biodefense experts assigned letter grades to each of the  capabilities for different types of outbreak. The report assigned low marks  to nearly all the capabilities for address large-scale and global disease  outbreaks. For example, the team assigned the grade of D (meets few  expectations) to the capability for detecting large-scale infectious  outbreaks and the grade of F (fails to meet expectations) to the capability  for detecting global contagious outbreaks.

In 2014, a Blue Ribbon Study Panel on Biodefense (Study Panel) was  established to assess gaps and provide recommendations to improve  U.S. biodefense. The panel’s October 2015 final report identified 33  recommendations to execute over the short, medium, and long term. The  Study Panel report echoed many of the same challenges highlighted in  the WMD Center’s report, and highlighted a sense of urgency to address  the ongoing and persistent biological threats—both naturally occurring,  like Ebola and Zika, and from enemies, like The Islamic State of Iraq and  the Levant (also known as ISIL and Da’esh) who have advocated for the  use of biological weapons. The panel’s report identified several themes  we have also highlighted in our biosurveillance work, including the lack of  a centralized leader, no comprehensive national strategic plan, and no all- inclusive dedicated budget for biodefense.

section_title: The Biodefense Enterprise Is Fragmented and Does Not Have Strategic Oversight to Promote Efficiency and Accountability
subsections: section_title: The Biodefense Enterprise Does Not Have Enterprise-Wide Institutionalized Leadership to Provide Strategic Oversight and Coordination
paragraphs: In 2011, we reported that reducing fragmentation in the biodefense  enterprise could enhance assurance that the nation is prepared to  prevent, detect, and respond to biological attacks with potentially  devastating consequences in terms of loss of life, economic damage, and  decreased national security. We reported that there are more than two  dozen presidentially appointed individuals with some responsibility for  biodefense. In addition, numerous federal agencies, encompassing much  of the federal government, have some mission responsibilities for  supporting biodefense activities. However, there is no individual or entity  with responsibility, authority, and accountability for overseeing the entire  biodefense enterprise. Because none of the federal departments has  authority over the entire biodefense enterprise, in 2011 we reported that  the Homeland Security Council (HSC) should consider establishing a  focal point to coordinate federal biodefense activities. In December 2014  officials from National Security Council (NSC) staff, which supports the  HSC told us that two of its directorates work together as the focal point for  federal biodefense efforts. According to NSC staff, these focal points  provide strategic leadership on all federal biodefense efforts, with  responsibilities to coordinate across domestic and global priorities to  prevent, detect, and rapidly respond to biological threats. The focal points  are to host ongoing meetings with the federal biodefense enterprise to  ensure a comprehensive and coordinated approach to biodefense.

We recognize the policy work of the directorates as an important step in  promoting a comprehensive and coordinated approach to biodefense, but  strategic leadership issues persist. In October 2015, the Study Panel  reported on ongoing leadership challenges for the enterprise. The report  called for a focal point to provide strategic leadership by elevating  authority above what any single agency has to help overcome the  challenges faced by the biodefense enterprise. The Study Panel report  noted mixed opinions on the effectiveness of the current NSC staff model  for coordinating biodefense. Some have asserted that efforts remain  fragmented under this system, but others pointed to the benefit of having  a wider variety of staff involved across the spectrum of biodefense  activities. However, the Study Panel found that White House councils and  offices generally only become involved when a specific biodefense issue  affects a prominent ongoing responsibility—a method which is not  consistent with our call for a strategic approach.

section_title: The Enterprise Does Not Have an Integrated National Strategy to Guide Priorities and Investments
paragraphs: In 2011, we reported that while some high-level biodefense strategies  have been developed, there is no broad, integrated national strategy that  encompasses all stakeholders with biodefense responsibilities that can be  used to guide the systematic identification of risk; assess resources  needed to address those risks; and prioritize and allocate investment  across the entire biodefense enterprise. We have also previously  reported that choices must be made about protection priorities given the  risk and how to best allocate available resources. Further, neither the  Office of Management and Budget nor the federal agencies account for  biodefense spending across the entire federal government. As a result,  the federal government does not know how much is being spent on this  critical national security priority. We reported that the overarching  biodefense enterprise would benefit from strategic oversight mechanisms,  including a national strategy, to ensure efficient, effective, and  accountable results, and suggested the HSC take action.

As of February 2016, NSC staff had not developed such a strategy.  Rather, they assert that the National Strategy for Countering Biological  Threats, the National Biosurveillance Strategy, and Presidential Policy  Directive-8 work in concert to provide comprehensive strategic guidance  to stakeholders with biodefense responsibilities. Although these  documents demonstrate clear commitment to coordinating interagency  biodefense efforts, they do not provide the strategic approach that we  suggested in March 2011. For example, the National Biosurveillance  Strategy, released by the White House in July 2012, does not provide a  specific framework for prioritizing and trading off among approaches to  build biosurveillance capabilities with limited resources. Moreover, as  previously discussed, there are four pillars of the biodefense enterprise,  each complex and in need of coordination: (1) threat awareness, (2)  prevention and protection, (3) surveillance and detection, and (4)  response and recovery. The National Strategy for Biosurveillance does  not—alone or in combination with the National Strategy for Countering  Biological Threats and Presidential Policy Directive-8—address all four  pillars, and more specifically, it does not address the key fragmentation  issues across the biodefense enterprise, such as ensuring strong linkage  and identifying gaps in investments across the four pillars.

Similarly, the Study Panel’s 2015 report identified the lack of a  comprehensive national strategy and dedicated budget as challenges.  The Study Panel noted that leadership issues were exacerbated by the  lack of a comprehensive biodefense strategy and a unified approach to  budgeting, which they called vital to any strategic interagency effort for  the nation’s biodefense capabilities. They called for a unified approach to  budgeting and prioritizing biodefense efforts. The Study Panel noted that  the nation lacks a comprehensive, cohesive, and regularly updated  strategy resulting in disorganization and loss of institutional knowledge  associated with changes in administrations.

section_title: Biosurveillance Faces Similar Challenges
paragraphs: Much like biodefense, biosurveillance faces key challenges that  transcend what any one agency can address on its own. We have  identified challenges related to the nation’s ability to detect and respond  to biological events. Our findings have identified challenges at all levels  of government, and our more recent and ongoing work continues to  highlight these challenges.
subsections: section_title: Enterprise-wide Leadership and Strategy Challenges
paragraphs: 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 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. We recommended the  HSC establish a focal point to lead the development of a national  biosurveillance strategy that clarifies roles and responsibilities, provides  goals and performance measures, and identifies resource and investment  needs, among other elements. However, the recommendations have not  been fully implemented.

The NSC staff, which supports the HSC, convened an interagency policy  group that guided the completion of the National Strategy for  Biosurveillance in July 2012, which addresses the intent of our  recommendation to establish a focal point. However, our review of the  strategy determined that the strategy alone did not fully meet the intent of  our recommendation because, among other things, it did not provide the  mechanism we recommended to identify resource and investment needs,  including investment priorities. Subsequent to the release of the strategy,  the NSC staff published a companion implementation plan, but it is not  yet clear the extent to which the plan has been widely shared among and  adopted by interagency decision makers as a means to help identify  opportunities to leverage resources and direct priorities.

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  biosurveillance strategy. The backbone of biosurveillance is traditional  disease-surveillance systems—designed to collect information on the  health of humans and animals to support a variety of public-welfare and  economic goals. These systems support biosurveillance efforts by  recording national health and disease trends and providing specific  information about the scope and projection of outbreaks to inform  response. Because the resources that constitute a 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. Such an assessment of capabilities that  support biosurveillance is called for in HSPD-10, which notes that the  United States requires a periodic assessment that identifies gaps or  vulnerabilities in our biodefense capabilities—of which surveillance and  detection is a key part—to guide prioritization of federal investments.  However, in a 2011 report, 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 in our October 2011 report  that the federal government would lack key information about the baseline  status, strengths, weaknesses, and gaps across the biosurveillance  enterprise until it conducts such an assessment. To address these issues,  and building on our June 2010 recommendation to develop a national  biosurveillance strategy, we recommended for such a strategy to (1)  incorporate a means to leverage existing efforts that support nonfederal  biosurveillance capabilities, (2) consider challenges that nonfederal  jurisdictions face, and (3) include a framework to develop a baseline and  gap assessment of nonfederal jurisdictions’ capabilities. However, the  July 2012 strategy did not adequately address the issues we raised  related to state and local biosurveillance and acknowledged but did not  meaningfully address the need to leverage nonfederal resources.

section_title: Challenges for Biosurveillance Capabilities
paragraphs: Our recent work has also identified challenges with specific  biosurveillance capabilities. Specifically, we have identified  biosurveillance capability challenges with, among other topics, (1) state  and local public heath capabilities, (2) animal health surveillance  capabilities, and (3) two DHS specific biosurveillance efforts—the  National Biosurveillance Integration Center (NBIC) and the BioWatch  Program. In our October 2011 report on nonfederal biosurveillance  efforts, we found 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.

State and Local Public Health Capabilities. In 2011, we found 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 reported facing workforce  shortages among skilled professionals—epidemiologists, informaticians,  statisticians, laboratory staff, animal-health staff, or animal-disease  specialists. We also found that although the federal government provided  some resources to help control disease in humans and animals in tribal  and insular areas, there were no specific efforts to ensure that their efforts  can contribute to the national biosurveillance capability. Additionally, in  2011, we found that nonfederal partners relied heavily on grants and  cooperative agreements to sustain their biosurveillance capabilities. For  example, the Public Health Emergency Preparedness cooperative  agreement (PHEP) and the Epidemiology and Laboratory Capacity for  Infectious Diseases cooperative agreement (ELC) were essential for  public health epidemiology and laboratory staff. We concluded that  without assessing the baseline nonfederal capabilities that support  biosurveillance, identification of investment needs for a national  biosurveillance capability cannot be established.

Animal Surveillance Capabilities. In the area of animal surveillance, we  reported in May 2013 that USDA’s Animal and Plant Health Inspection  Service (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 also 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 had 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  proposed monitoring these facilities for a range of other diseases as well.  However, we concluded that without integrating APHIS’s 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. We recommended that APHIS integrate its new surveillance  approach with an overall strategy that guides how its new approach will  support national homeland security efforts to enhance the detection of  biological threats. However, while the agency agreed, this  recommendation has not been implemented.

DHS Biosurveillance Efforts. In 2015, we identified persistent  challenges related to two of DHS’s biosurveillance capabilities, NBIC and  the BioWatch program. We reported in 2009 that NBIC was not fully  equipped to carry out its mission because it lacked key resources—data  and personnel—from its partner agencies, which may have been at least  partially the result of collaboration challenges it faced. For example,  some partners reported that they did not trust NBIC to use their  information and resources appropriately, while others were not convinced  of the value that working with NBIC provided because NBIC’s mission  was not clearly articulated. In the 2009 report, we recommended that  NBIC develop a strategy for addressing barriers to collaboration and  develop accountability mechanisms to monitor these efforts. DHS agreed,  and in August 2012, NBIC issued the NBIC Strategic Plan, which is  intended to provide NBIC’s strategic vision, clarify the center’s mission  and purpose, and articulate the value that NBIC seeks to provide to its  partners, among other things. In September 2015, we reported that  despite NBIC’s efforts to collaborate with interagency partners to create  and issue a strategic plan that would clarify its mission and efforts, a  variety of challenges remained. Notably, many of its federal partners  continued to express uncertainty about the value NBIC provided. We  identified options for policy or structural changes that could help NBIC  better fulfill its biosurveillance integration mission, such as changes to  NBIC’s roles, but we did not make specific recommendations.

Additionally, since 2012, we have reported that DHS has faced  challenges in clearly justifying the need for the BioWatch program and its  ability to reliably address that need (to detect aerosolized biological  attacks). In September 2012, we found that DHS approved a next- generation BioWatch acquisition in October 2009 without fully developing  knowledge that would help ensure sound investment decision making and  pursuit of optimal solutions. We recommended that before continuing  the acquisition, DHS reevaluate the mission need and possible  alternatives based on cost-benefit and risk information. DHS concurred  and in April 2014, canceled the acquisition because an alternatives  analysis did not confirm an overwhelming benefit to justify the cost.  Having canceled the next generation acquisition, DHS continues to rely  on the currently-deployed BioWatch system for early detection of an  aerosolized biological attack. However, in 2015, we found that DHS lacks  reliable information about the current system’s technical capabilities to  detect a biological attack, in part because in the 12 years since  BioWatch’s initial deployment, DHS has not developed technical  performance requirements for the system. We reported in October 2015  that DHS commissioned tests of the current system’s technical  performance characteristics, but without performance requirements, DHS  cannot interpret the test results and draw conclusions about the system’s  ability to detect attacks. DHS is considering upgrades to the current  system, but we recommended that DHS not pursue upgrades until it  establishes technical performance requirements to meet a clearly defined  operational objective and assesses the system against these  performance requirements. DHS concurred and is working to address the  recommendation.

Chairman Johnson, Ranking Member Carper, and Members of the  Committee, this concludes my prepared statement. I would be happy to  respond to any questions you may have.

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. 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 (Assistant Director), Susanna Kuebler (Analyst- In-Charge), Russ Burnett, Marcia Crosse, Mary Denigan-Macauley,  Tracey King, Jan Montgomery, Steve Morris, and Tim Persons. 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.


Question-summary annotations: questions: question: What is a big issue of the biodefense enterprise?
answer: The biodefense enterprise is fragmented and does not have strategic oversight to promote efficiency and accountability.

question: How does this issue play into leadership?
answer: Specifically, the biodefense enterprise lacks institutionalized leadership enterprise-wide to provide strategic oversight and coordination.
child_questions: question: How is the responsibility of overseeing performed?
answer: In 2011, GAO reported, there are more than two dozen presidentially appointed individuals with biodefense responsibilities and numerous federal agencies with mission responsibilities for supporting biodefense activities, but no individual or entity with responsibility for overseeing the entire biodefense enterprise.

question: How does the GAO suggest HSC solve the lack of leadership?
answer: In 2011, GAO reported that the Homeland Security Council (HSC) should consider establishing a focal point for federal biodefense coordination.

question: How has the NSC tackled the issue of leadership?
answer: In December 2014, National Security Council (NSC) staff, which supports the HSC, told GAO that two of its directorates work together as the focal point for federal biodefense efforts.
child_questions: question: What further steps can still be taken?
answer: This is an important step in promoting a comprehensive and coordinated approach to biodefense, but strategic leadership issues persist.

question: How did the Blue Ribbon Study Panel on Biodefense call to further leadership action?
answer: In October 2015, a report by the Blue Ribbon Study Panel on Biodefense stated strategic leadership issues persist and called for a focal point to provide strategic leadership, noting that elevating authority above the agency-level can help overcome the challenges faced by the biodefense enterprise.
child_questions: question: How did this report conflict with the GAO's approach?
answer: The Study Panel found that White House councils and offices generally only become involved when a specific biodefense issue affects a prominent ongoing responsibility—a method which is not consistent with our call for a strategic approach.

questions: question: How did the GAO evaluate biodefense in 2011?
answer: In 2011, GAO also reported that while some high-level biodefense strategies have been developed, there is no broad, integrated national strategy that encompasses all stakeholders with biodefense responsibilities that can be used to guide the systematic identification of risk; assess resources needed to address those risks; and prioritize and allocate investment across the entire biodefense enterprise.

question: How did the GAO suggest biodefense improve?
answer: GAO reported that the overarching biodefense enterprise would benefit from strategic oversight mechanisms, including a national strategy, to help ensure efficient, effective, and accountable results, and suggested the HSC take action.
child_questions: question: What action has been taken on their suggestion?
answer: However, as of February 2016, such a strategy had not been developed.

questions: question: What challenges does biosurveillance face?
answer: Biosurveillance, an aspect of biodefense, also faces key challenges at all levels of government that transcend what any one agency can address on its own, and our more recent and ongoing work continues to highlight these challenges.

question: What did GAO recommend regarding the establishment of a biosurveillance strategy?
answer: In 2010, GAO recommended the HSC establish a focal point to lead the development of a national biosurveillance strategy that clarifies roles and responsibilities, provides goals and performance measures, and identifies resource and investment needs, among other elements.
child_questions: question: How have these recommendations been implemented?
answer: However, the recommendations have not been fully implemented.

question: What other issues did the GAO find with biosurveillance?
answer: Since 2009 GAO's has also identified challenges with specific biosurveillance capabilities.
child_questions: question: What are some of these challenges?
answer: Specifically, GAO has identified biosurveillance capability challenges with, among other topics, (1) state and local public heath capabilities, (2) animal health surveillance capabilities, and (3) two Department of Homeland Security biosurveillance efforts—the National Biosurveillance Integration Center (NBIC) and the BioWatch Program (which aims to provide early indication of an aerosolized biological weapon attack).
child_questions: question: How have these challenges been addressed?
answer: However, not all recommendations have been implemented.

questions: question: What does this statement address?
answer: This statement summarizes GAO's work on challenges to building and maintaining the nation's biodefense and biosurveillance.

question: What is the report based on?
answer: This statement is based on GAO work issued from December 2009 through March 2016 on various biodefense and biosurveillance efforts.
child_questions: question: What did the GAO additionally review?
answer: GAO also reviewed the 2015 report of the Blue Ribbon Study Panel on Biodefense for updates, but has not independently assessed the entirety of the conclusions, recommendations or methods.

question: What work did the GAO review to prepare for the report?
answer: To conduct the prior work, GAO reviewed relevant laws, presidential directives, policies, strategic plans, and other reports; surveyed states; and interviewed federal, state, and industry officials, among others.