Biodefense: The Nation Faces Long-Standing Challenges Related to Defending Against Biological Threats

Catastrophic biological events have the potential to cause loss of life, and sustained damage to the economy, societal stability, and global security. The biodefense enterprise is the whole combination of systems at every level of government and the private sector that contribute to protecting the nation and its citizens from potentially catastrophic effects of a biological event. Since 2009, GAO has identified cross-cutting issues in federal leadership, coordination, and collaboration that arise from working across the complex interagency, intergovernmental, and intersectoral biodefense enterprise. In 2011, GAO reported that there was no broad, integrated national strategy that encompassed all stakeholders with biodefense responsibilities and called for the development of a national biodefense strategy. In September 2018, the White House released a National Biodefense Strategy.

This statement discusses GAO reports issued from December 2009 through March 2019 on various biological threats and biodefense efforts, and selected updates to BioWatch recommendations made in 2015. To conduct prior work, GAO reviewed biodefense reports, relevant presidential directives, laws, regulations, policies, strategic plans; surveyed states; and interviewed federal, state, and industry officials, among others.

GAO's past work has identified a number of challenges related to the nation's ability to detect and respond to biological events that transcend what any one federal department or agency can address on its own. They include, among others:

Assessing enterprise-wide threats. In October 2017, GAO found there was no existing mechanism across the federal government that could leverage threat awareness information to direct resources and set budgetary priorities across all agencies for biodefense. GAO said at the time that the pending biodefense strategy may address this.

Situational awareness and data integration. GAO reported in 2009 and 2015 that the Department of Homeland Security's (DHS) National Biosurveillance Integration Center (NBIC)—created to integrate data across the federal government to enhance detection and situational awareness of biological events—has suffered from longstanding challenges related to its clarity of purpose and collaboration with other agencies. DHS implemented GAO's 2009 recommendation to develop a strategy, but in 2015 GAO found NBIC continued to face challenges, such as limited partner participation in the center's activities.

Biodetection technologies. DHS has faced challenges in clearly justifying the need for and establishing the capabilities of the BioWatch program—a system designed to detect an aerosolized biological terrorist attack. In October 2015, GAO recommended that DHS not pursue upgrades until it takes steps to establish BioWatch's technical capabilites. While DHS agreed and described a series of tests to establish capabilities, it continued to pursue upgrades.

Biological laboratory safety and security. Since 2008, GAO has identified challenges and areas for improvement related to the safety, security, and oversight of high-containment laboratories, which, among other things, conduct research on hazardous pathogens—such as the Ebola virus. GAO recommended that agencies take actions to avoid safety and security lapses at laboratories, such as better assessing risks, coordinating inspections, and reporting inspection results. Many recommendations have been addressed, but others remain open, such as finalizing guidance on documenting the shipment of dangerous biological material.

In September 2018, the White House issued the National Biodefense Strategy and associated plans, which could help to address some of the ongoing challenges GAO has previously identified. However, because implementation of the strategy is in early stages, it remains to be seen how or to what extent the agencies responsible for implementation will institutionalize mechanisms to help the nation make the best use of limited biodefense resources. GAO is currently reviewing the strategy and will report out later this year.

GAO has made numerous agency recommendations in its prior reports designed to address the challenges discussed in this statement. As of June 2019, agencies have taken steps to address many of these, and GAO is monitoring ongoing efforts.

I am pleased to be here today to discuss our work on long-standing  biodefense challenges. Catastrophic biological events have the potential  to cause loss of life and sustained damage to the economy, societal  stability, and global security. Among those biological threats is the  unpredictable nature of naturally-occurring disease, which could affect  human and animal health and agricultural security. Further, while the  revolution in biotechnology presents opportunities to advance the life  sciences, that same technology in the wrong hands could be used to  create crippling biological weapons. For example, according to the Blue  Ribbon Study Panel on Biodefense, nonstate actors such as terrorist  organizations, domestic militia groups, and “lone wolves” have both the  interest and capacity to develop biological weapons. Thus, the scientific  community must safeguard the biological agents it uses to assess threats  and must protect laboratory workers and the population at large from the  intentional or accidental release of dangerous pathogens during the  pursuit of more knowledge about them.

The biological threat landscape is vast and requires a multidisciplinary  approach. The biodefense enterprise is the whole combination of systems  at every level of government and the private sector that 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. We have reported that complex  interagency and intergovernmental efforts can benefit from developing a  national strategy. In addition, we reported 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. Recognizing the  fragmentation and the need for an integrated strategy to address  biodefense challenges, in March 2011 we reported that reducing  fragmentation in the biodefense enterprise could provide confidence 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. At that time, we  reported that while some high-level biodefense strategies have been  developed, there was no broad, integrated national strategy that  encompassed all stakeholders with biodefense responsibilities to guide  the systematic identification of risk; assess resources needed to address  those risks; and prioritize and allocate investment across the biodefense  enterprise. Since that time, others, including the Congress, have also  called for the development of a national biodefense strategy.

In September 2018, in response to a statutory requirement in the National  Defense Authorization Act for Fiscal Year 2017, the White House  released the National Biodefense Strategy and National Security  Presidential Memorandum-14 (NSPM-14), which establishes a  governance structure to guide the strategy’s implementation. Part of the  governance structure includes the creation of a Biodefense Steering  Committee chaired by the Secretary of Health and Human Services. The  other members of the Committee include the Attorney General, the  Secretaries from the Departments of State, Defense (DOD), Agriculture  (USDA), Veterans Affairs (VA), and Homeland Security (DHS), and the  Administrator of the Environmental Protection Agency (EPA). The  steering committee is responsible for monitoring and coordinating the  implementation of the Strategy. The National Defense Authorization Act  also included a provision for us to review the strategy, and we have  ongoing work in this area.

We reported on a wide range of biodefense-related issues in which we  have examined the threat of biological terrorism and specific surveillance  programs and activities aimed to identify emerging infectious diseases  carried out by multiple federal departments and agencies. Since 2009, we  have identified broad, cross-cutting issues in leadership, coordination,  and collaboration that arise from working across the complex interagency,  intergovernmental, and intersectoral biodefense enterprise.

As such, this statement describes a range of ongoing challenges to  building and maintaining the nation’s biodefense, as well as the new  National Biodefense Strategy which is intended to help address them.  These include challenges related to (1) threat determination, (2)  situational awareness and data integration, (3) biodetection technologies,  (4) biological laboratory safety and security, and (5) emerging infectious  disease surveillance. The statement is based on our prior work issued  from December 2009 through March 2019 on various biological threats  and biodefense efforts, and selected updates related to our 2015 work on  DHS’s BioWatch Program.

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. Selected updates were obtained in the course of follow-up  on prior recommendations from 2015. More information on our scope and  methodology can be found in each of the reports cited throughout this  statement. 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.

The Nation Faces Ongoing Challenges Across the Biodefense Enterprise

Our past work has identified five key challenges related to the nation’s  ability to detect and respond to biological events that transcend what any  one agency can address on its own. They include: (1) enterprise-wide  threat determination, (2) situational awareness and data integration, (3)  biodetection technologies, (4) biological laboratory safety and security,  and (5) emerging infectious disease surveillance. The complexity and  fragmentation of roles and responsibilities across numerous federal and  nonfederal entities presents challenges to ensuring efficiency and  effectiveness across the entire biodefense enterprise. In September  2018, the White House issued the National Biodefense Strategy and  through NSPM-14 established a governance structure to guide its  implementation. The activities and responsibilities assigned to the  interagency governance body by the strategy and NSPM-14 may create  new opportunities to make progress on these longstanding and complex  issues. However, because implementation of the Strategy and NSPM-14  are in early stages, it remains to be seen how or to what extent they are  able to do so. We have ongoing work assessing the strategy and early  efforts to implement it. We plan to report in fall 2019.

Enterprise-Wide Threat Determination Needed to Help Leverage Resources and Inform Resource Tradeoffs

We reported in October 2017 that opportunities remain to enhance threat  awareness across the entire biodefense enterprise, leverage shared  resources, and inform budgetary tradeoffs among various threats and  agency programs. As depicted in figure 1, we reported in October 2017  that key biodefense agencies, including DHS, DOD, HHS, USDA, and  EPA, rely on intelligence and global surveillance information, scientific  study of disease agent characteristics, and analysis to better understand  threats and help make decisions about biodefense investments. These  activities are often conducted to support the agencies’ mission or to  understand a specific threat.

Additionally, to facilitate collaboration among government partners,  federal agencies with key roles in biodefense share biological threat  information through many different mechanisms including interagency  bodies, working groups at the agency and executive level, formalized  agreements, colocation, joint projects and funding efforts, and shared  expertise (see figure 2).

The collaborative mechanisms in which the key agencies in our October  2017 review participated may facilitate information sharing in support of  specific federal activities and in individual programs, or in response to  specific biological events after they begin to unfold. However, as we  reported in October 2017, there was no existing mechanism that could  leverage threat awareness information to direct resources and set  budgetary priorities across all agencies for biodefense. The nation faces  many biological threats, including naturally occurring diseases that affect  human, animal, and plant health, and biological weapons used by state or  nonstate actors. Without a mechanism that is able to assess the relative  risk from biological threats across all sources and domains, the nation  may be limited in its ability to prioritize resources, defenses, and  countermeasures against the most pressing threats.

The Strategy and NSPM-14 outline requirements for participating  agencies that lay the ground work for a more systematic, cross- government examination of existing programs. The effort offers the  potential for the nation to progress toward more integrated and  enterprise-wide threat awareness and to use that information to identify  opportunities to leverage resources, but this will take time and entails a  change in the way participating agencies have traditionally operated.  Because implementation of the strategy is in its early stages, it is too  soon to assess how, if at all, it might address this challenge.

Ongoing Challenges to Fulfill Enhanced Situational Awareness and Data Integration Requirements

We have reported that DHS’s National Biosurveillance Integration Center  (NBIC), which was created to integrate data across the federal  government with the aim of enhancing detection and situational  awareness of biological events, has suffered from long-standing issues  related to its clarity of purpose. In 2009, we reported that some of NBIC’s  partners were not convinced of the value that working with NBIC provided  because NBIC’s mission was not clearly articulated. We also reported  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. 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, to provide its 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. We  identified options for policy or structural changes that could help a federal  data integrator like NBIC better fulfill its mission, given the complexity and  difficulty inherent in achieving truly integrated situational awareness that  makes new meaning out of disparate data, but we did not make specific  recommendations.

The National Biodefense Strategy identified biosurveillance data  integration among several information sharing activities that need to be  enhanced. Interagency attention to the goals, opportunities, and  challenges of enterprise-wide data integration offers the potential for the  nation to better define what kind of integrated situational awareness is  possible, what it will take to effectively and efficiently achieve it, and what  value it has. However, it remains to be seen how or whether the  interagency efforts to implement the Strategy will be able to address  ongoing situational awareness and data integration challenges.

Challenges Determining Optimal Biodetection Technology Solutions

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. DHS continues to rely  on the currently-deployed BioWatch system for early detection of an  aerosolized biological attack, but in 2015 we found that DHS lacked  reliable information about the current system’s technical capabilities to  detect a biological attack, in part because DHS had not developed  technical performance requirements for the system. We reported in  September 2015 that DHS commissioned tests of the current system’s  technical performance characteristics, but without performance  requirements, DHS could not interpret the test results and draw  conclusions about the system’s ability to detect attacks.

At the time of our report in October 2015, DHS was considering upgrades  to the Gen-2 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 reported it was  working to address the recommendation. DHS has since begun to acquire  a different type of biodetection system, BioDetection 21 (or BD21),  intended to replace BioWatch. BD21 is currently in a pilot phase;  therefore we cannot yet determine how it will be implemented in the future  or what decisions DHS will ultimately make regarding the existing  BioWatch system.

In August 2017, we reported that from a homeland security and public  health perspective, threats of bioterrorism, such as anthrax attacks, and  high-profile disease outbreaks, such as Ebola and emerging viruses like  dengue, chikungunya, and Zika, highlight the continued need for  diagnostic tests that provide early detection and warning about biological  threats to humans. Multiplex point-of-care technologies are technologies  that can simultaneously test for more than one type of human infectious  disease pathogen from a single patient sample (such as blood, urine, or  sputum) in one run at or near the site of a patient. Multiplex point-of-care technologies can be used for diagnosing different diseases,  including more common diseases such as influenza, emerging infectious  diseases, or diseases caused by select agents in minutes to a few hours.

We further reported that, while potential benefits of these technologies  include more appropriate use of antibiotics and improved ability to limit  the spread of disease, among others, developers and users disagreed on  the strength of evidence showing the extent of multiplex point-of-care  technologies’ improvement on patient outcomes and identified the need  for more clinical studies to establish the benefits of these technologies.  Additionally, implementation challenges include lack of familiarity with  such technologies, cost considerations, false positive results for rare  diseases, and the challenges related to the regulatory review process for  developers to get approval or clearance to market their technologies.

The National Biodefense Strategy and its interagency governing  leadership offer the potential for the nation to better define the role of  detection technologies in a layered national biodefense capability to help  those that pursue these technologies better articulate the mission needs  and align requirements and concepts of operation accordingly. Because  implementation of the strategy is in its early stages, it remains to be seen  how or whether the interagency will be able engage on this issue in a way  that helps to drive informed investment tradeoff decisions about  technology alternatives.

Continued Oversight Needed to Enhance Biological Laboratory Safety and Security

Addressing Safety Lapses at Laboratories

We—along with Congress and various federal committees—have, for  many years, identified challenges and areas for improvement related to  the safety, security, and oversight of high-containment laboratories.  These laboratories conduct research on hazardous pathogens—such as  the Ebola virus and the bacteria that causes anthrax—and toxins that  may pose a serious threat to humans, animals, or plants. In 2008 and  2009, we found a proliferation of high-containment laboratories across the  United States, with the number of such laboratories in the government,  academic, and private sectors increasing since 2001. We recommended  that the National Security Advisor name an entity charged with  government-wide strategic evaluation of high-containment laboratories.  National Security Staff disagreed with this recommendation. After  reporting on these issues again in 2013, the Office of Science and  Technology Policy implemented this recommendation. In January 2013,  we also found that, for the subset of these laboratories subject to federal  oversight, the oversight was duplicative, fragmented, and dependent on  self-policing. We recommended that HHS’s Centers for Disease Control  and Prevention and USDA’s Animal and Plant Health Inspection Service  work with DHS and DOD to coordinate inspections and ensure consistent  application of inspection standards; the departments generally agreed  with our recommendations and noted various actions they had already  taken, or planned to take, to coordinate inspection efforts, such as  conducting joint inspections.

More recently, in response to reported lapses in laboratory safety at HHS  and DOD in 2014 and 2015, we examined how federal departments  oversee their high-containment laboratories. In March 2016, we found  that most of the 8 departments and 15 agencies that we reviewed had  policies that were not comprehensive or were not up to date. Also, while  the departments and agencies we reviewed primarily used inspections to  oversee their high-containment laboratories, some of them were not  routinely reporting inspection results, laboratory incidents, and other  oversight activities to senior officials. We made 33 recommendations in  total, including that departments develop and update policies to include  missing elements and ensure that oversight activity results are reported to  senior officials. To date, 12 of the 33 recommendations have been  implemented—including updating policies and reporting requirements.  We continue to monitor agency progress in implementing the 21 that  remain open.

In response to several incidents involving the shipment of improperly  inactivated pathogens, in August 2016 we reported on issues related to  the inactivation of pathogens in high-containment laboratories and found  that both the science and the federal guidance around pathogen  inactivation are limited and inconsistently implemented. Additionally, we  found that federal officials did not know how many incomplete inactivation  incidents have occurred because laboratories do not have to identify them  in incident reports, and are only required to report incidents involving  certain pathogens. We made 11 recommendations to HHS and USDA  that they improve the oversight of inactivation by revising reporting forms,  improving guidance for development and validation of inactivation  protocols, and developing consistent criteria for enforcement of incidents  involving incomplete inactivation. To date, 6 of the 11 recommendations  have been addressed and we continue to monitor the 5 that remain  open.

Safety lapses continued to occur at laboratories in the United States that  conduct research on hazardous pathogens, raising concern about the  efficacy of federal oversight. In October 2017, we found that the Federal  Select Agent Program—jointly managed by HHS and USDA—oversees  laboratories’ handling of certain hazardous pathogens known as select  agents, but the program does not fully meet all key elements of effective  oversight. For example, the Federal Select Agent Program was not  independent from all laboratories it oversees, and it had not assessed  risks posed by its current structure or the effectiveness of its mechanisms  to reduce organizational conflicts of interest. We made 11  recommendations for the Federal Select Agent Program, including to (1)  assess risks from its current structure and the effectiveness of its  mechanisms to reduce conflicts of interest and address risks as needed,  (2) assess the risk of activities it oversees and target reviews to high-risk  activities, and (3) develop a joint workforce plan; to-date, 5 of 11  recommendations have been addressed and we continue to monitor the  progress for the 6 that remain open.

In September 2018 we found that DOD had made progress by taking a  number of actions to address the 35 recommendations from the Army’s  2015 investigation report on the inadvertent shipment of live anthrax;  however, DOD had not yet developed an approach to measure the  effectiveness of these actions. Additionally, we reported that although  DOD had implemented a Biological Select Agents and Toxins Biosafety  and Biosecurity Program to improve management, coordination, safety,  and quality assurance, DOD had not developed a strategy and  implementation plan for managing the program. Also, we found that the  Army had not fully institutionalized measures to ensure that its biological  test and evaluation mission remains independent from its biological  research and development mission so that its test and evaluation  procedures are objective and reliable. Finally, DOD had not completed a  required study and evaluation of its Biological Select Agents and Toxins  infrastructure that will affect the future infrastructure of the Biological  Select Agents and Toxins Biosafety and Biosecurity Program. DOD  officials had no estimated time frames for when DOD will complete the  study and evaluation. We recommended that DOD develop an approach  to assess the effectiveness of the recommendations, a strategy and  implementation plan for its Biological Select Agents and Toxins Biosafety  and Biosecurity Program, measures to ensure independence, and time  frames to complete a study. To date, all of these recommendations  remain open. In agency comments, DOD concurred with all four of our  recommendations and discussed the actions the department intended to  take to address them, including finalizing the development of a long-term  strategy and implementation plan by September 1, 2019.

The National Biodefense Strategy highlights the need for continuous  improvement of biosafety and biosecurity for laboratories and other  facilities. However, it is not yet known how, if at all, the strategy will drive  interagency partners to develop additional oversight or other practices to  mitigate the risk of bioincidents at high containment laboratories, because  implementation of the strategy is in its early stages.

Challenges Building and Maintaining Emerging Infectious Disease Surveillance

We have reported that establishing and sustaining biosurveillance  capabilities can be difficult for a myriad of reasons. For example,  maintaining expertise in a rapidly changing field is difficult, as is the  challenge of accurately recognizing the signs and symptoms of rare or  emerging diseases. Additionally, we reported in October 2011 that  funding targeted for specific diseases does not allow for focus on a broad  range of causes of morbidity and mortality, and federal officials have said  that the disease-specific nature of funding is a challenge to states’ ability  to invest in core biosurveillance capabilities. Further, we reported in May  2018 that although the awards funded by supplemental appropriations  have allowed state and local public health departments, laboratories, and  hospitals to surge during a threat—for example, the H1N1influenza and  Zika viruses—most of the 10 non-federal stakeholders we interviewed, as  well as HHS officials said that the timing of these awards can result in  challenges to carrying out preparedness and response activities during  infectious disease threats.

An effective medical response to a biological event depends in part on the  ability of individual clinicians and other professionals to identify,  accurately diagnose, and effectively treat diseases, including many that  may be uncommon. For example, in May 2017, we reported that because  Zika virus disease was a newly emerging disease threat in the United  States and relatively little was known about the virus prior to 2016, HHS  and state and local public health agencies were not fully equipped with  information and resources needed for a rapid response at the outset of  the recent outbreaks. They faced challenges establishing and  implementing surveillance systems for Zika virus disease and infection  and its associated health outcomes. Additionally, in March 2019, we  reported that USDA would likely face surveillance challenges that could  delay detection of the first cases in a foot-and-mouth disease outbreak in  livestock, which could have a devastating impact on our economy and  trade agreements. For example, foot-and-mouth disease can spread  without detection as signs can be difficult to notice in some species, take  up to 4 days to manifest after an animal is infected, and infection in wild  animals could go undetected and continue to spread the virus.

In 2011, while reporting on nonfederal biosurveillance efforts, we found  state and local agriculture, public health, and wildlife departments were  completely or largely dependent on federal funding for biosurveillance- related activities. At that time, we also reported that the common federal  approach of disease-specific funding—for example, West Nile virus— limited nonfederal efforts to develop core capabilities that could provide  surveillance capacity that cut across health threats and for emerging- disease threats.

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. In May 2018, we reported that officials from HHS  told us that their grant awards funded by annual appropriations are  intended to establish and strengthen emergency preparedness and  capacity building, but may not fully support the need for surge capacity  that states and other jurisdictions require in order to respond to an  infectious disease threat. We reported that during recent infectious  disease threats, HHS received supplemental appropriations to respond to  Zika in 2016, Ebola in 2014, and H1N1 pandemic influenza in 2009.  However, as mentioned above, officials also said that the timing of these  awards can result in challenges to carrying out preparedness and  response activities during infectious disease threats.

HHS officials, as well as all 10 selected non-federal stakeholders, also  noted in May 2018 that a funding mechanism to fund rapid response  activities when additional support is needed would be beneficial and could  help address timing challenges. However, we reported that concerns  were also raised about (1) when such a mechanism for funding infectious  disease threats should be used, and (2) that any type of emergency fund  should not be used to make up for a lack in investments at all levels of  government for current preparedness and capacity-building activities. We  did not make recommendation as part of this work. However, part of our  May 2018 reporting included perspectives from various stakeholders on  such a fund. Stakeholders cited six factors that may be considered for a  new emergency response fund: (1) who determines when to use an  emergency fund, (2) what factors would trigger the use of an emergency  fund, (3) methods to determine the amount of available funding, (4)  activities to fund with an emergency fund, (5), accountability for use of an  emergency fund, and (6) whether an emergency fund would be specific to  infectious disease threats.

The National Biodefense Strategy and its interagency governance  structure offer the opportunity to design new approaches to identifying  and building a core set of surveillance and response capabilities for  emerging infectious diseases. However, it is too early into implementation  to determine how effective, if at all, the new strategy will be in addressing  this challenge. How and to what extent implementation of the Strategy is  able to efficiently leverage and effectively sustain capacity across both  nonfederal and federal stakeholders will affect how prepared the nation is  to more quickly gear up for whatever challenges emerge when outbreaks  of previously non-endemic diseases threaten the nation.

Thank you, Chairman Lynch, Ranking Member Hice, and Members of the  Subcommittee. This concludes my prepared statement. I would be happy  to respond to any question you may have at this time.

If you or your staff has any questions concerning this testimony, please  contact Christopher P. 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), Nick Bartine,  Jeffrey Cirillo, Michele Fejfar, Eric Hauswirth, Tracey King, Dawn Locke,  and Adam Vogt. Key contributors for the previous work that this testimony  is based on are listed in each product.

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While the biotechnology revolution presents opportunities for scientific breakthroughs, in the wrong hands these technologies could help create biological weapons with catastrophic impacts.

How do we defend against these and other biological threats, including naturally-occurring diseases?

We testified before a House committee on our work on the nation's long-standing biodefense challenges. We identified key challenges in the nation's ability to detect and respond to biological events that transcend what a single agency can address. For example, agencies need to work together to assess the relative risk from a variety of biological threats.