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. 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. Diseases among wildlife can also provide early  warnings of environmental damage, bioterrorism, and other risks to   human health. 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 Biodefense Enterprise Is Fragmented and Does Not Have Strategic Oversight to Promote Efficiency and Accountability

		The Biodefense Enterprise Does Not Have Enterprise-Wide Institutionalized Leadership to Provide Strategic Oversight and Coordination

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. 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. 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. 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. 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. The Enterprise Does Not Have an Integrated National Strategy to Guide Priorities and Investments

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 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. Biosurveillance Faces Similar Challenges

Much like biodefense, biosurveillance faces key challenges that  transcend what any one agency can address on its own. Our findings have identified challenges at all levels  of government, and our more recent and ongoing work continues to  highlight these challenges. 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. Challenges for Biosurveillance Capabilities

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. However, while the agency agreed, this  recommendation has not been implemented. DHS Biosurveillance Efforts.
Why GAO Did This Study

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.

What GAO Found

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.