BIODEFENSE

The Nation Faces 

Multiple Challenges in 

Building and 

Maintaining 

Biodefense and 

Biosurveillance

Statement of Chris Currie, Director, Homeland Security 

and Justice

Testimony 

Before the Committee on Homeland 

Security and Governmental Affairs

U.S. Senate

For Release on Delivery 

Expected at 10 a.m. ET

Thursday, April 14, 2016

GAO-16-547T

United States Government Accountability Office
United States Government Accountability Office

Highlights of GAO-16-547T, a testimony 

before the Committee on Homeland Security 

and Governmental Affairs, U.S. Senate

April 2016

BIODEFENSE

The Nation Faces Multiple Challenges in Building and 

Maintaining Biodefense and Biosurveillance

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.

View GAO-16-547T. For more information, 

contact Chris Currie at 404-679-1875 or 

curriec@gao.gov.
Letter

Page 1 GAO-16-547T 

Chairman Johnson, Ranking Member Carper, and Members of the 

Committee:

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 (HSPD10), 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.1 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, 

 1

Homeland Security Presidential Directive 10: Biodefense for the 21st Century (2004).

Letter
Page 2 GAO-16-547T 

and resources needed to provide assurance that the federal programs are 

well coordinated, and that gaps and duplication in capabilities are 

avoided.2 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.3 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 

 2

See GAO, Combating Terrorism: Selected Challenges and Related Recommendations, 

GAO-01-822 (Washington, D.C: Sept. 20, 2001), and Combating Terrorism: Evaluation of 

Selected Characteristics in National Strategies Related to Terrorism, GAO-04-408T 

(Washington, D.C.: Feb. 3, 2004).

3

See, for example, GAO, Emerging Infectious Diseases: Review of State and Federal 

Disease Surveillance Efforts, GAO-04-877 (Washington, D.C.: Sept. 30, 2004), which 

discusses select federal and nonfederal human disease surveillance in humans; GAO, 

Global Health: U.S. Agencies Support Programs to Build Overseas Capacity for Infectious 

Disease Surveillance, GAO-07-1186 (Washington, D.C.: Sept. 28, 2007), which discusses 

four key programs aimed at building overseas surveillance capacity for infectious diseases 

in humans; GAO, Biosurveillance: Developing a Collaboration Strategy Is Essential to 

Fostering Interagency Data and Resource Sharing, GAO-10-171 (Washington, D.C.: Dec. 

18, 2009); GAO, Biosurveillance: Efforts to Develop a National Biosurveillance Capability 

Need a National Strategy and a Designated Leader, GAO-10-645 (Washington, D.C.: 

June 30, 2010); GAO, Biosurveillance: Nonfederal Capabilities Should Be Considered in 

Creating a National Biosurveillance Strategy, GAO-12-55 (Washington, D.C.: Oct. 31, 

2011); GAO, Biosurveillance: DHS Should Reevaluate Mission Need and Alternatives 

before Proceeding with BioWatch Generation-3 Acquisition, GAO-12-810 (Washington, 

D.C.: Sept. 10, 2012); GAO, Homeland Security: An Overall Strategy Is Needed to 

Strengthen Disease Surveillance in Livestock and Poultry, GAO-13-424 (Washington, 

D.C.: May 21, 2013), which discusses the Department of Agriculture’s efforts to better 

detect and control new or reemerging diseases in animals; GAO, Biosurveillance: 

Challenges and Options for the National Biosurveillance Integration Center, GAO-15-793 

(Washington, D.C.: Sept. 24, 2015); GAO, Biosurveillance: DHS Should Not Pursue 

BioWatch Upgrades or Enhancements Until System Capabilities Are Established, 

GAO-16-99 (Washington, D.C.: Oct. 23, 2015).GAO, Emerging Infectious Diseases: 

Preliminary Observations on the Zika Virus Outbreak, GAO-16-470T (Washington, D.C., 

Mar.2, 2016). 
Page 3 GAO-16-547T 

for selected updates.4 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.

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.

 4

We have not independently assessed the entirety of the Study Panel’s conclusions and 

recommendations or the methods it used to arrive at them. However, we determined that 

the select members of panels related to leadership and policy issues had qualifications 

and subject matter expertise sufficient to provide reliable information on issues related to 

strategy and leadership across the biodefense enterprise.

Background

The Biodefense Enterprise
Page 4 GAO-16-547T 

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).

Figure 1: Pillars of Biodefense
Page 5 GAO-16-547T 

Emerging infectious diseases represent an ongoing threat to the health 

and livelihoods of people and animals worldwide.5 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.6 Infectious 

diseases are a continuous threat for reasons that include: (1) 

emergence—at times rapid—of new infectious diseases; (2) reemergence 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 2014.7

 5

According to the Centers for Disease Control and Prevention (CDC), an emerging 

infectious disease is a disease whose incidence in humans has increased in the past two 

decades or threatens to increase in the near future. 

6

Institute of Medicine, Emerging Viral Diseases: The One Health Connection 

(Washington, D.C.: National Academies Press, 2015).

7

See GAO, Air Travel and Communicable Diseases: Comprehensive Federal Plan 

Needed for U.S. Aviation System’s Preparedness. GAO-16-127.(Washington, D.C.: 

December 16, 2015).

Biosurveillance Threats 

and Responsibilities
Page 6 GAO-16-547T 

Figure 2: Top Five U.S. International Arrival Airports for Five Global Regions, 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 
Page 7 GAO-16-547T 

human health.8 Finally, potential bioterrorism threats also include the use 

of zoonotic diseases as weapons of mass destruction, such as anthrax, 

plague, tularemia, and brucellosis.

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.9 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.10 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. 11 Some 

 8

Department of Interior’s United States Geological Survey National Wildlife Health Center, 

which is the only federal laboratory in the United States dedicated to wildlife disease 

investigation, focuses on developing methods to reduce or eliminate the transmission of 

diseases among wildlife, domestic animals, and humans. 

9

In particular, agencies with missions that do not entail health surveillance activities may 

play a supporting biosurveillance role on an ongoing or ad hoc basis. For example, as 

demonstrated during the 2009-2010 H1N1 influenza pandemic, the Department of 

Education provided information on school closings, which enhanced situational 

awareness. In another example, although the National Weather Service does not have 

health surveillance responsibilities, the National Biosurveillance Integration Center (NBIC) 

may at times coordinate with this agency because understanding weather patterns helps 

predict the course of some outbreaks. 

10HSPD-21, Public Health and Medical Preparedness, was issued in October 2007 to 

establish a National Strategy for Public Health and Medical Preparedness, which builds 

upon principles set forth in HSPD-10 with the goal of transforming the national approach 

to protecting the health of the American people against all disasters.

11According to the Department of the Interior’s definition, an insular area is a jurisdiction 

that is neither a part of one of the several states nor a federal district. This is the current 

term to refer to any U.S. commonwealth, freely associated state, possession, or territory.

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).

James Gathany (photograph ) 

Source: GAO analysis;| GAO-16-547T
Page 8 GAO-16-547T 

of the nonfederal partners with key responsibilities in the biosurveillance 

enterprise are presented in table 1.

Table 1: Selected Biosurveillance Roles and Responsibilities

Nonfederal partner Description

Skilled Personnel

Epidemiologists Epidemiologists are specialists who study how diseases are distributed and transmitted in 

populations and the factors that influence or determine this distribution and transmission.

Informaticians Public-health informaticians use systematic application of information, computer science, and 

technology to support public health.

State public-health veterinarians State public health veterinarians typically work for the state health department and generally 

work in zoonotic disease control and prevention with a focus on protecting public health.

State wildlife professionals State wildlife professionals are veterinarians, epidemiologists, biologists, or management 

personnel who work for state departments of wildlife, parks and recreation, or natural 

resources and environment.

Clinicians and diagnosticians Early detection of a bioterrorism event or the emergence of a naturally occurring infectious 

disease threat may depend on an astute clinician diagnosing the first few cases, or recognizing 

suspicious clinical signs that require further investigation by experts in infectious diseases.

Organizations

State and local health departments States, through the use of their state and local health departments, have principal 

responsibility for protecting the public’s health and therefore take the lead in conducting 

disease surveillance. They verify cases of notifiable diseases, monitor disease incidence, and 

identify possible outbreaks within their states. Generally, local health departments are 

responsible for conducting

initial investigations into reports of infectious diseases. Local health departments are also 

responsible for sharing information they obtain from providers or other sources with their state 

department of health.

State departments of agriculture State departments of agriculture provide services and regulations regarding the health of 

agricultural animals. States maintain a list of reportable diseases and require accredited 

veterinarians to report disease occurrences. State veterinarians coordinate the efforts of state 

animal-health officials who have authority for disease reporting, detection, and often, 

diagnosis.

Laboratories Public-health and animal-health laboratories serve a critical role in both initial detection and 

ongoing situational awareness of biological events.

Source: GAO | GAO-16-547T

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 

Independent Reports on 

Issues Facing the 

Biodefense Enterprise
Page 9 GAO-16-547T 

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.12

In 2014, a Blue Ribbon Study Panel on Biodefense (Study Panel) was 

established to assess gaps and provide recommendations to improve 

U.S. biodefense.13 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 allinclusive dedicated budget for biodefense.

 12The WMD Center, Bio-Response Report Card: 21st Century Biological Threats, 

Washington, D.C. (Oct 2011). 

13A National Blueprint for Biodefense: Leadership and Major Reform Needed to Optimize 

Efforts. Bipartisan Report of the Blue Ribbon Study Panel on Biodefense (October 2015).

The Biodefense 

Enterprise Is 

Fragmented and 

Does Not Have 

Strategic Oversight to 

Promote Efficiency 

and Accountability
Page 10 GAO-16-547T 

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.14 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.15 The Study Panel report 

noted mixed opinions on the effectiveness of the current NSC staff model 

 14See, Opportunities to Reduce Potential Duplication in Government Programs, Save Tax 

Dollars, and Enhance Revenue. GAO-11-318SP. Washington, D.C.: March 1, 2011. 

15The Study Panel evaluated various organizational models to provide leadership, and 

ultimately recommended that leadership for the biodefense enterprise be institutionalized 

in the Office of the Vice President and that the Vice President be given budget authority to 

review and advise, in collaboration with the Office of Management and Budget, all 

biodefense budgets. Although our prior work called for an entity with sufficient time, 

resources, and authority to provide strategic oversight across the enterprise, we have not 

independently evaluated any specific leadership models. 

The Biodefense Enterprise 

Does Not Have 

Enterprise-Wide 

Institutionalized 

Leadership to Provide 

Strategic Oversight and 

Coordination
Page 11 GAO-16-547T 

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.

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.16 We have also previously 

reported that choices must be made about protection priorities given the 

risk and how to best allocate available resources.17 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 

 16GAO-11-318SP

17GAO, 21st Century Challenges: Reexamining the Base of the Federal Government, 

GAO-05-325SP (Washington, D.C.: Feb. 1, 2005). 

The Enterprise Does Not 

Have an Integrated 

National Strategy to Guide 

Priorities and Investments
Page 12 GAO-16-547T 

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.

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.18 Our findings have identified challenges at all levels 

of government, and our more recent and ongoing work continues to 

highlight these challenges.

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.19 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 

 18See GAO-10-645; GAO-12-55; GAO-15-793; and GAO-16-99. 

19GAO-10-645. 

Biosurveillance Faces 

Similar Challenges

Enterprise-wide Leadership 

and Strategy Challenges
Page 13 GAO-16-547T 

sustaining a national biosurveillance capability.20 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 

 20See GAO-10-645; GAO, Combating Terrorism: Selected Challenges and Related 

Recommendations, GAO-01-822 (Washington, D.C: Sept. 20, 2001), and Combating 

Terrorism: Evaluation of Selected Characteristics in National Strategies Related to 

Terrorism, GAO-04-408T (Washington, D.C.: Feb. 3, 2004).
Page 14 GAO-16-547T 

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.21

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.

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 

 21GAO-12-55. In 2011, we reported that certain aspects of public-health capabilities have 

been assessed by federal agencies and professional associations. For example, CDC’s 

guidance associated with the Public Health Emergency Preparedness (PHEP) cooperative 

agreement began to define elements, priorities, resource considerations, and metrics for 

building and assessing public-health surveillance, epidemiology, and laboratory 

capabilities. However, in 2013, we reported on ways to better assess the effect of 

cooperative agreements on awardee preparedness, including that of the PHEP. We 

reported that creating comprehensive performance management systems with realistic 

targets and incremental milestones would aid in assessing performance. However, as of 

September 2015, HHS was still working to address our recommendations. See, National 

Preparedness: Improvements Needed for Measuring Awardee Performance in Meeting 

Medical and Public Health Preparedness Goals, GAO-13-278 (Washington, D.C.: March 

2013). 

Challenges for Biosurveillance 

Capabilities
Page 15 GAO-16-547T 

capabilities, and (3) two DHS specific biosurveillance efforts—the 

National Biosurveillance Integration Center (NBIC) and the BioWatch 

Program.22 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.23 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 

 22DHS’s BioWatch program aims to provide early indication of an aerosolized biological 

weapon attack. 

23See, GAO-12-55. 
Page 16 GAO-16-547T 

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.24 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.25 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.26 For example, 

some partners reported that they did not trust NBIC to use their 

 24GAO-13-424.

25See, GAO-15-793 and GAO-16-99. 

26GAO-10-171. 
Page 17 GAO-16-547T 

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.27

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 nextgeneration BioWatch acquisition in October 2009 without fully developing 

knowledge that would help ensure sound investment decision making and 

pursuit of optimal solutions.28 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.29 We reported in October 2015 

 27GAO-15-793. 

28GAO-12-810. 

29GAO-16-99.
Page 18 GAO-16-547T 

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.

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 (AnalystIn-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.

GAO Contact and 

Staff 

Acknowledgments

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