BIOSURVEILLANCE

Observations on BioWatch 

Generation-3 and Other 

Federal Efforts

Statement of William O. Jenkins, Jr., Director 

Homeland Security and Justice

Testimony 

Before the Subcommittees on Emergency Preparedness, 

Response, and Communications and Cybersecurity, 

Infrastructure Protection, and Security Technologies 

Committee on House Homeland Security, House of 

Representatives

For Release on Delivery 

Expected at 2:00 p.m. EDT

September 13, 2012

GAO-12-994T

United States Government Accountability Office

GAO
United States Government Accountability Office

Highlights of GAO-12-994T, a testimony 

before the Subcommittees on Emergency 

Preparedness, Response, and Communications 

and Cybersecurity, Infrastructure Protection, and 

Security Technologies, Committee on Homeland 

Security, House of Representatives

September 13, 2012

BIOSURVEILLANCE 

Observations on BioWatch Generation-3 and Other 

Federal Efforts 

Why GAO Did This Study

A catastrophic biological event could 

have devastating consequences. The 

U.S. government has efforts to provide 

early detection and warning of 

biological threats. DHS’s BioWatch, 

which aims to detect certain pathogens

in the air, is one such program. DHS 

has been pursuing a third generation of 

BioWatch technology (Gen-3) to further 

enhance detection. GAO has published 

a series of reports on national 

biosurveillance efforts, including a 

report released today on DHS’s efforts 

to acquire Gen-3. This statement 

discusses (1) prior biosurveillance 

work and related federal efforts, (2) 

today’s report on the Gen-3 

acquisition, and (3) prior strategy 

recommendations and the White 

House’s July 2012 National Strategy 

for Biosurveillance. This statement is 

based on GAO reports published from

December 2009 to September 2012 

and GAO’s review of the National 

Strategy for Biosurveillance in relation 

to prior GAO recommendations for a 

national biosurveillance strategy.

What GAO Recommends

In prior reports, GAO made 

biosurveillance recommendations to 

DHS and the White House Homeland 

Security Council. DHS concurred with 

prior recommendations. The White 

House did not comment. In today’s 

report, GAO recommended that before 

continuing the Gen-3 acquisition, DHS 

reevaluate the mission need and 

alternatives and update associated 

performance, schedule, and cost 

information. DHS concurred but stated 

it plans to reevaluate the acquisition

and pursue performance testing 

concurrently. We believe DHS should 

first develop the critical information we 

recommended. 

What GAO Found

The Department of Homeland Security (DHS) and the White House have acted

to strengthen biosurveillance consistent with prior GAO recommendations made 

from December 2009 through October 2011.In August 2012, DHS issued a 

strategic plan for its National Biosurveillance Integration Center (NBIC) that

officials say was written in coordination with federal partners and designed to 

respond to GAO’s December 2009 findings that NBIC did not have key resources 

to carry out its mission, in part due to collaboration issues it faced. In July 2012, 

the White House released the National Strategy for Biosurveillance, which 

describes guiding principles, core functions, and enablers for strengthening 

biosurveillance. In June 2010, GAO recommended a national biosurveillance 

strategy to provide a unifying framework for building and maintaining a national 

biosurveillance capability. In October 2011, GAO also recommended the strategy 

account for the need to leverage resources and respond to challenges while 

partnering with nonfederal entities. The July 2012 strategy partially responds to

the issues GAO called for such a strategy to address, but does not fully address 

them, as discussed below. A strategic implementation plan is to be published 

within 120 days of strategy issuance (October 2012), and may align the strategy 

more fully with the array of issues GAO identified.

DHS approved the Generation-3 (Gen-3) acquisition in October 2009, but it did 

not fully engage its acquisition framework to ensure that the acquisition was 

grounded in a justified mission need and that it pursued an optimal solution. The 

performance, schedule, and cost expectations presented in required documents 

when DHS approved the acquisition were not developed in accordance with DHS 

guidance and good acquisition practices—like accounting for risk in schedule and 

cost estimates. Since October 2009, the estimated date for full deployment has 

been delayed from fiscal year 2016 to fiscal year 2022. The 2009 life-cycle cost 

estimate—a point estimate unadjusted for risk—was $2.1 billion. In June 2011, 

DHS provided a risk-adjusted estimate at the 80 percent confidence level of $5.8 

billion. Several steps remain before DHS can fully deploy Gen-3 including 

additional performance testing, operational testing, and developing location 

specific deployment plans.

The White House’s National Strategy for Biosurveillance serves as a foundation 

for enterprisewide efforts and begins to define mission, goals, and objectives, as 

we called for in making the June 2010 strategy recommendation; however, the 

strategy does not yet offer the mechanism GAO recommended to identify 

resource and investment needs, including investment priorities. Accordingly, the 

biosurveillance enterprise remains without a framework to guide the systematic 

identification of risk, assessment of resources needed to address those risks, 

and the prioritization and allocation of investment across the entire enterprise. In 

recommending a national strategy, GAO recognized the challenges individual 

federal programs and agencies face prioritizing resources to help ensure a 

coherent effort across the dispersed biosurveillance enterprise. Today’s report on 

Gen-3 offers a timely and concrete example of this challenge—to assess the 

extent to which Gen-3 warrants the investment of scarce resources when the

incremental value of the environmental monitoring Gen-3 offers is considered as 

part of a layered biosurveillance strategy. 

View GAO-12-994T For more information, 

contact William O. Jenkins at (202) 512-8757 

or jenkinswo@gao.gov.
 

Page 1 GAO-12-994T 

Chairmen Bilirakis and Lungren and members of the Subcommittees: 

I am pleased to have the opportunity to be here today to discuss our 

biosurveillance work, with particular focus on the Department of 

Homeland Security’s (DHS) BioWatch Generation-3 (Gen-3) program.1

The U.S. government has a long history of employing disease 

surveillance activities to help limit malady, loss of life, and economic 

impact. Traditional disease surveillance activities involve trained 

professionals engaged in monitoring, investigating, confirming, and 

reporting in an effort to further various missions including, but not limited 

to, detecting signs of pathogens in humans, animals, plants, food, and the 

environment. However, in recent years, experts and practitioners, 

reacting to an increasing awareness of the speed and intensity with which 

a biological weapon of mass destruction or highly pathogenic strain of 

emerging infectious disease could affect the nation, have sought to 

augment traditional surveillance activities with biosurveillance programs 

and systems. DHS’s BioWatch program is an example of such an effort. It 

aims to reduce the time required to recognize and characterize potentially 

catastrophic aerosolized attacks by detecting the presence of five 

biological agents—considered to be at a high risk for weaponized 

attack—in the air.

A 

catastrophic biological event, such as a terrorist attack with a weapon of 

mass destruction or a naturally occurring pandemic, could cause 

thousands of casualties or more, weaken the economy, damage public 

morale and confidence, and threaten national security. In recent years, 

there has been an increasing awareness of the potential for biological 

agents to be used as weapons of mass destruction and of the threat of 

catastrophic effects arising from emerging strains of infectious disease. 

For example, events like the 2001 Amerithrax incident, which killed 5 

people and sickened 17, and the global pandemic resulting from 

emergence of a novel strain of influenza in 2009, have brought increased 

attention to intentional and naturally occurring biological threats.

The currently deployed BioWatch technology—Generation-2 (Gen-2)—

can take 12 to 36 hours to confirm the presence of pathogens. DHS has 

 

1

The National Strategy for Biosurveillance defines “biosurveillance” as the process of 

gathering, integrating, interpreting, and communicating essential information related to allhazards threats or disease activity affecting human, animal, or plant health to achieve 

early detection and warning, contribute to overall situational awareness of the health 

aspects of an incident, and enable better decision making at all levels. 

 
 

Page 2 GAO-12-994T 

been pursuing Gen-3 with the goal of implementing a system that will 

perform automated testing, potentially generating a result in under 6 

hours and eliminating certain labor costs. Expressing questions about 

whether DHS had undertaken a rigorous effort to help guide its Gen-3 

decision making, two subcommittees of this committee asked us to 

examine issues related to the Gen-3 acquisition. Today, we released a 

report that evaluates the acquisition decision-making process for Gen-3.2

In addition, since December 2009, we have published three other reports 

about efforts across the federal government and with nonfederal partners 

to enhance the nation’s biosurveillance capabilities.3

To describe recent federal efforts that align with our work published from

December 2009 through October 2011, we reviewed the National 

Biosurveillance Integration Center Strategic Plan and the National 

Strategy for Biosurveillance, and obtained information from DHS officials. 

To develop findings in the report released today about Gen-3, which this 

statement is largely based on, we reviewed DHS’s acquisition guidance, 

including Acquisition Management Directive 102-01. Additionally, we 

reviewed acquisition documentation and interviewed agency officials from 

the BioWatch program and other DHS offices with development, policy, 

and acquisition responsibilities. We then compared the information 

developed from our documentation review and interviews against the 

guidance. More detailed information on our scope and methodology 

appears in our published work .To make observations about the National 

Strategy for Biosurveillance, we analyzed the strategy and assessed its 

alignment with findings and recommendations about a the need for a 

national biosurveillance strategy in prior work. We conducted this work 

This statement (1) 

describes recent federal efforts that align with our biosurveillance work 

published from December 2009 through October 2011, (2) discusses our 

Gen-3 acquisition findings, and (3) makes observations about our prior 

strategy recommendations and the White House’s recently released 

National Strategy for Biosurveillance. 

 

2

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).

3

GAO, Biosurveillance: Developing a Collaboration Strategy Is Essential to Fostering 

Interagency Data and Resource Sharing, GAO-10-171 (Washington, D.C.: Dec. 18, 2009); 

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); and 

Biosurveillance: Nonfederal Capabilities Should Be Considered in Creating a National 

Biosurveillance Strategy, GAO-12-55 (Washington, D.C.: Oct. 31, 2011). 
 

Page 3 GAO-12-994T 

from August 2012 to September 2012 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. 

In December 2009, we published a report assessing DHS’s efforts to 

establish the National Biosurveillance Integration Center (NBIC). We 

reported that NBIC was not fully equipped to carry out its mission 

because it lacked key resources—data and personnel—from its partner 

agencies, a situation that could be at least partially attributed to 

collaboration challenges NBIC faced. We recommended that NBIC work 

with its federal partners to develop a strategy to enhance collaboration—

including sharing data, personnel, and other resources—and to establish 

effectiveness measures for that collaboration. DHS generally concurred 

with our findings and recommendations and stated that NBIC would work 

with its partners to develop a collaboration strategy to clarify both the 

mission space and roles and responsibilities for all partners.4

In June 2010, we reported on federal efforts that support a national 

biosurveillance capability and the extent to which mechanisms were in 

place to guide the development of a national biosurveillance capability. 

We reported that a national biosurveillance capability would largely rely 

on an interagency effort because the activities and accompanying 

resources that support the capability—personnel, training, equipment, 

and systems—are dispersed across a number of federal agencies. 

In August 

2012, DHS issued the National Biosurveillance Integration Center 

Strategic Plan. According to DHS officials, the plan articulates a clear 

approach with a series of measurable steps and initiatives to enhance the 

nation’s biosurveillance capability. In late August 2012, when providing us 

with a copy of the strategy, officials stated that they believe it satisfies the 

intent of our recommendations. Officials said the plan was written in 

coordination with NBIC’s federal partners and is the result of a 

deliberative process examining NBIC’s current capabilities and capability 

gaps. We are currently assessing the extent to which the plan fully 

responds to the recommendations.

 

4

GAO-10-171. 

DHS and the White 

House Have Taken 

Action to Enhance 

Biosurveillance 
 

Page 4 GAO-12-994T 

However, we found that the federal government did not have a unifying 

framework and structure for integrating dispersed capabilities and 

responsibilities and no federal agency had authority to guide and oversee 

the development and implementation of a national effort that 

encompassed all stakeholders with biosurveillance responsibilities. We 

concluded that without such a framework and an entity with the authority, 

resources, time, and responsibility for guiding its implementation, it would 

be very difficult to create an integrated approach to building and 

sustaining a national biosurveillance capability. We recommended that 

the Homeland Security Council within the White House direct the National 

Security Staff to identify, in consultation with relevant federal agencies, a 

focal point to lead the development of such a strategy. 

Our June 2010 report also noted that a national biosurveillance capability 

depends upon participation from state, local, and tribal governments, 

because few of the resources required to support the capability are wholly 

owned by the federal government. In October 2011, we reported on how 

the federal government worked with its nonfederal partners to support 

biosurveillance, activities those partners identified as essential to their 

biosurveillance efforts, and particular challenges those partners faced. 

We recommended that the strategy we called for in June 2010 

incorporate a means to leverage existing efforts that support nonfederal 

biosurveillance capabilities, consider challenges that nonfederal 

jurisdictions face, and include a framework to develop a baseline and gap 

assessment of nonfederal jurisdictions’ biosurveillance capabilities.5

In July 2012, the White House released the National Strategy for 

Biosurveillance to describe the U.S. government’s approach to 

strengthening biosurveillance. The strategy describes guiding principles, 

core functions, and enablers for strengthening biosurveillance. The 

strategy states that its approach emphasized teamwork between and 

within federal departments, across all layers of government, and with 

private sector partners. A strategic implementation plan is to be 

completed within 120 days of the strategy issuance. The strategy does 

not fully meet the intent of our June 2010 and October 2011 

recommendations, as discussed later in this statement, but it is possible 

that it will when the implementation plan is complete.

The 

White House did not comment on these recommendations.

 

5

GAO-12-55. 
 

Page 5 GAO-12-994T 

DHS approved the Gen-3 acquisition in October 2009 without fully 

developing critical knowledge that would help ensure sound investment 

decision making, pursuit of optimal solutions, and reliable performance, 

cost, and schedule information. Specifically, DHS did not engage the 

initial phase of its Acquisition Life-cycle Framework, which is designed to 

help ensure that the mission need driving the acquisition warrants 

investment of limited resources.6

However, DHS began to pursue a specific autonomous detection solution 

well before completing a Mission Needs Statement. Specifically, DHS’s 

Integrated Planning Guidance (IPG) for fiscal years 2010-2014, which 

was finalized in March 2008, included specific goals for the next 

generation of BioWatch—to deploy in all major cities an autonomous 

BioWatch detection device reducing the operating cost per site by more 

than 50 percent and warning time to less than 6 hours. The purpose of 

DHS’s IPG is to communicate the Secretary’s policy and planning goals 

to component-level decision makers to inform their programming, 

budgeting, and execution activities. As such, this specific set of goals for 

BioWatch Gen-3 demonstrates that DHS leadership had established a 

In the Acquisition Life Cycle Framework 

design, it is not the purpose of the Mission Needs Statement to specify a 

technical solution. Rather it is to serve as a touchstone for subsequent 

acquisition efforts by focusing on the capability gap to help articulate and 

build consensus around the goals and objectives for a program.

 

6

According to DHS officials, the Gen-3 acquisition was ongoing when Acquisition 

Management Directive 102-01 was issued. The officials said that many DHS programs 

that were ongoing in 2009 faced similar challenges. Nevertheless, DHS Management 

Directive 1400, which preceded Acquisition Management Directive 102-01, was similarly 

designed to, among other things, ensure that investments directly support and further 

DHS’s missions. Like Acquisition Management Directive 102-01, Management Directive 

1400 describes a phased lifecycle investment construct in which the first step is defining 

the mission need in a Mission Needs Statement. As with the Mission Need Statement 

called for in Acquisition Management Directive 102-01, the statement in Management 

Directive 1400 was to be a high-level description of a capability gap rather than a specific 

solution.

DHS Did Not Develop 

Critical Knowledge 

before Proceeding 

with the Gen-3 

Acquisition 

DHS Proceeded with the 

Gen-3 Acquisition before 

Establishing a Mission 

Need
 

Page 6 GAO-12-994T 

course for the acquisition by March 2008, in advance of efforts to define 

the mission need through the Mission Needs Statement process, which 

was finalized more than a year and a half later.

DHS officials in multiple departments described a climate, in the wake of 

the September 11, 2001, terrorist attacks and the subsequent Amerithrax

attacks, in which the highest levels of the administration expressed 

interest in quickly deploying the early generation BioWatch detectors and 

improving their functionality—as quickly as possible—to allow for faster 

detection and an indoor capability. BioWatch officials stated that they 

were aware that the Mission Needs Statement prepared in October 2009 

did not reflect a systematic effort to justify a capability need, but stated 

that the department directed them to proceed because there was already 

departmental consensus around the solution. Accordingly, the utility of the 

Mission Needs Statement as a foundation for subsequent acquisition 

efforts was limited.

Additionally, DHS did not use the processes established by its Acquisition 

Life-cycle Framework to systematically ensure that it was pursuing the 

optimal solution—based on cost, benefit, and risk—to mitigate the 

capability gap identified in the Mission Needs Statement. The DHS 

Acquisition Life-cycle Framework calls for the program office to develop 

an Analysis of Alternatives that systematically identifies possible 

alternative solutions that could satisfy the identified need, considers costbenefit and risk information for each alternative, and finally selects the 

best option from among the alternatives.

However, the Analysis of Alternatives prepared for the Gen-3 acquisition 

did not reflect a systematic decision-making process. For example, in 

addition to—or perhaps reflecting—its origin in the predetermined solution 

from the Mission Needs Statement, the Analysis of Alternatives did not 

fully explore costs or consider benefits and risk information as part of the 

analysis. Instead, the Analysis of Alternatives focused on just one cost 

metric that justified the decision to pursue autonomous detection—cost 

per detection cycle—to the exclusion of other cost and benefit 

considerations that might have informed decision makers.7

 

7

Cost per detection cycle is the cost each time an autonomous detector tests the air for 

pathogens or the cost each time a Gen-2 filter is manually collected and tested in a 

laboratory.

Additionally, 

the Analysis of Alternatives examined only two alternatives, though the

DHS Did Not 

Systematically Analyze 

Alternatives
 

Page 7 GAO-12-994T 

guidance calls for at least three. The first alternative was the currently 

deployed Gen-2 technology with a modified operational model (which by 

definition was unable to meet the established goals). The second 

alternative was the complete replacement of the deployed Gen-2 program 

with an autonomous detection technology and expanded deployment.

BioWatch program officials acknowledged that other options—including 

but not limited to deploying some combination of both technologies, 

based on risk and logistical considerations—may be more cost-effective. 

As with the Mission Needs Statement, program officials told us that they 

were advised that a comprehensive Analysis of Alternatives would not be 

necessary because there was already departmental consensus that 

autonomous detection was the optimal solution.

Because the Gen-3 Analysis of Alternatives did not evaluate a complete 

solution set, did not consider complete cost information, did not consider 

benefits, and did not include a cost-benefit analysis, it does not provide 

information on which to base trade-off decisions. For example, it does not 

provide information about the extent to which various aspects of the 

solution—such as the number of participating jurisdictions—results in a 

reduction of risk and at what cost. Given the uncertainty related to Gen3’s costs, benefits, and risk mitigation potential, DHS does not have 

reasonable assurance that the strategy of expanding and completely 

replacing the existing Gen-2 program with autonomous detection 

technology is the most cost-effective solution. 

In October 2009, DHS approved the Gen-3 acquisition at Acquisition 

Decision Event (ADE) 2A—one of the key formal decision points in DHS’s 

Acquisition Life-cycle Framework—based on information contained in 

acquisition documents provided by the BioWatch program. One critical 

purpose of the ADE-2A documentation set required by DHS’s acquisition 

guidance is to describe the expected performance, cost, and schedule 

parameters for an acquisition. However, the ADE-2A Acquisition Decision 

Memorandum stated that significant data necessary for the proper 

adjudication of an ADE-2A decision were missing. Further, we reported

that some performance, cost, and schedule expectations presented at 

ADE-2A were not developed in accordance with DHS guidance and good 

acquisition practices—like accounting for risk in schedule and cost 

estimates.

On the basis of the Gen-3 documentation submitted at ADE-2A, DHS 

expected to acquire a system that would cost $2.1 billion, be fully 

deployed by fiscal year 2016, and meet certain performance 

DHS Did Not Fully 

Develop Performance, 

Cost, and Schedule 

Information 
 

Page 8 GAO-12-994T 

requirements. However, the performance, cost, and schedule parameters 

for the Gen-3 acquisition have changed. Specifically, certain performance 

requirements have been revised, the estimated date for full deployment 

has been delayed from fiscal year 2016 to fiscal year 2022, and the 

expected life cycle cost has changed from the $2.1 billion point estimate 

prepared for ADE-2A to a risk-adjusted $5.8 billion estimate, calculated at 

the 80 percent confidence level.8

BioWatch program officials told us that they had to prepare ADE-2A 

documentation quickly because ADE-2A had been accelerated by more 

than a year. Additionally, DHS officials from multiple offices described a 

climate around the time of ADE-2A in which the department’s business 

processes—including acquisition practices—were maturing and thus were 

less rigorous in their adherence to best practices for cost and schedule 

estimating. However, in the absence of complete and reliable information, 

DHS had limited assurance that the acquisition would successfully deliver 

the intended capability within cost and on schedule. Comprehensive and 

systematic information developed using good practices for cost and 

schedule estimating could help ensure that more reliable performance, 

cost, and schedule information is available for future acquisition decision 

making.

We recommended that before continuing the acquisition, DHS reevaluate 

the mission need and alternatives and develop performance, cost, and 

schedule information in accordance with guidance and good acquisition 

practices. DHS concurred with the recommendations but plans to proceed 

with the next step in the acquisition—performance testing—while 

implementing them. We are pleased that DHS plans to implement the 

recommendation but are concerned by DHS’s intention to continue the 

acquisition efforts before ensuring that it has fully developed the critical 

 

8

The $2.1 billion life-cycle cost estimate (a point estimate) submitted at ADE-2A was the 

estimate used for planning purposes at the time. In the June 2011 Life-cycle Cost 

Estimate, the BioWatch program recommended the 80 percent confidence level for 

planning purposes. We present these estimates here in comparison because they are the 

two estimates used for planning purposes. However, it is important to note that June 2011 

estimates at the 28 percent and 80 percent confidence level are risk adjusted and the 

2009 point estimate is not. The point estimate at the 28 percent confidence level in the 

June 2011 Life-cycle Cost Estimate was $3.8 billion. The confidence level indicates the 

probability that the actual cost will be at or below the estimate. For example, the June 

2011 estimate of $5.8 billion conveys that (at the time of that estimate) the program 

anticipated 80 percent probability that the cost would be $5.8 billion or less.
 

Page 9 GAO-12-994T 

knowledge a comprehensive Acquisition Life-cycle Framework effort is 

designed to provide.

The BioWatch program completed initial testing and evaluation on a Gen3 prototype technology in June 2011, but several steps remain before 

Gen-3 can be deployed and operational.9

The Deputy Secretary of Homeland Security and other senior officials met 

on August 16, 2012 for an Acquisition Review Board, during which the 

BioWatch program was seeking approval to initiate the next phase of the 

acquisition. DHS did not make a final decision, but authorized release of a 

solicitation for performance testing under the next testing phase. In 

response to the recommendations we made in the Gen-3 report, DHS 

officials stated that before awarding a performance testing contract—

which would allow the program to acquire a small number of test units—

the program office is directed to return to the Acquisition Review Board 

for approval.

For example, the BioWatch 

program must complete additional testing. The characterization testing 

conducted in 2010 and 2011 was intended to assess the state of 

available technology. This testing sought to demonstrate the performance 

of available candidate Gen-3 technologies against the requirements 

established by the BioWatch program, and consisted primarily of 

laboratory testing of individual system components. This testing did not 

demonstrate the performance of the full system in detecting live 

pathogens in the operational environment. It also did not test the 

information technology network that will transmit results for public health 

officials. Now the program plans to conduct the next phase of testing—

performance testing in three independent laboratories and operational 

test and evaluation in four BioWatch jurisdictions. On the basis of the

June 2011 Life-cycle Cost Estimate, the BioWatch program estimates this 

testing will take approximately 3 years and cost approximately $89 million 

(risk adjusted at the 80 percent confidence level).

 

9

A second candidate technology participated in two test events—aerosol collection 

subsystem testing and assay evaluation—but did not complete all testing because the 

candidate system did not meet program requirements during the assay evaluation. 

Specifically, the second candidate technology yielded both false positives—detecting a 

BioWatch agent when none was present—and false negatives—not detecting an agent 

when one was present. 

Several Steps Remain 

before Gen-3 Is Ready for 

Deployment
 

Page 10 GAO-12-994T 

Before undertaking the remaining steps in the acquisition, the program 

office is directed to return for Acquisition Decision Event-2B (ADE-2B)—

the next formal decision point in DHS’s Acquisition Life-cycle 

Framework—with updated information, including an Analysis of 

Alternatives and Concept of Operations, as we recommended. No 

timeframe for completing these actions has been specified, but according 

to DHS officials, it may take up to 1 year to update the Analysis of 

Alternatives. In preparation for the August 16, 2012, meeting, the 

BioWatch program had updated key acquisition documents—including 

the Life-cycle Cost Estimate and Acquisition Program Baseline—as 

required by the Acquisition Decision Authority in a February 2012 memo. 

However, in order to inform the ADE-2B decision, these documents must 

accurately reflect changes to Gen-3 performance requirements and 

updated cost and schedule estimates for the acquisition and therefore

may require further revisions.

If approved at ADE-2B, the BioWatch program plans to conduct 

operational testing of Gen-3 units in four BioWatch jurisdictions. Following 

operational testing, DHS intends to decide whether to authorize the 

production and deployment of Gen-3. If Gen-3 is approved, the BioWatch 

program plans to prepare for deployment by working with BioWatch 

jurisdictions to develop location-specific plans to guide Gen-3 operations. 

DHS estimates based on the June 2011 Life-cycle Cost estimate show 

that about $5.7 billion of the $5.8 billion life-cycle cost (risk adjusted at the 

80 percent confidence level) remains to be spent to test, produce, deploy, 

and operate Gen-3 through fiscal year 2028.

In the report on Gen-3 released today, we noted that beyond the 

uncertainty related to the costs and benefits of the planned Gen-3 

approach, there is additional uncertainty about the incremental benefit of 

this kind of environmental monitoring as a risk mitigation activity because 

of its relatively limited scope. As the study committee for a 2011 National 

Academies evaluation of BioWatch noted, there is considerable 

uncertainty about the likelihood and magnitude of a biological attack, and 

how the risk of a release of an aerosolized pathogen compares with risks 

from other potential forms of terrorism or from natural diseases. The 

National Academies report also notes that while the BioWatch program is 

designed to detect certain biological agents (currently five agents) that 

could be intentionally released in aerosolized form, detecting a 

Observations about 

Prior Strategy 

Recommendations 

and the July 2012

National Strategy for 

Biosurveillance 
 

Page 11 GAO-12-994T 

bioterrorism event involving other pathogens or routes of exposure 

requires other approaches.10

In the report we released today, we stated that given the total estimated 

operating cost for the Gen-3 program, it is important, especially in an 

increasingly resource-constrained environment, to consider the benefit—

in terms of its ability to mitigate the consequences of a potentially 

catastrophic biological attack—that the investment provides. We noted 

that the scope limitations of this kind of environmental monitoring provide 

context in both the consideration of mission need and in analyzing cost 

effectiveness.11

However, it was not within the scope of our BioWatch Gen-3 study nor 

was it our intention to reach a firm conclusion about the value of this kind 

of activity as part of a layered biosurveillance strategy. Rather, we believe 

the need to consider value within the larger biosurveillance enterprise as 

part of an effort to define mission need for a single federal program like 

Gen-3 provides a timely and concrete illustration of the kind of issues we 

sought to address with our June 2010 recommendation. The 

recommendation for the Homeland Security Council to direct the National 

Security Staff to identify a focal point to lead the development of a 

national biosurveillance strategy was grounded in previous work on 

desirable strategy characteristics for complex homeland security 

missions. We recognized the difficulty that decision makers and program 

managers in individual federal agencies face prioritizing resources to help 

ensure a coherent effort across a vast and dispersed interagency, 

intergovernmental, and intersectoral network. Therefore, we called for a 

strategy that would, among other things, (1) define the scope and 

purpose of a national capability; (2) provide goals, objectives and 

activities, priorities, milestones, and performance measures; and (3) 

assess the costs and benefits and identify resource and investment 

needs, including investment priorities.12

 

10Institute of Medicine and National Research Council of the National Academies, 

Committee on Effectiveness of National Biosurveillance Systems, BioWatch and the 

Public Health System, BioWatch and Public Health Surveillance: Evaluating Systems for 

the Early Detection of Biological Threats (Washington, D.C.: 2011).

11GAO-12-810. 

12GAO-10-645. 
 

Page 12 GAO-12-994T 

We stated that one of the aims of a national biosurveillance strategy 

should be to help prioritize where resources and investments should be 

targeted and guide agencies to allocate resources accordingly. Further, 

we reported that a national strategy could begin to address the difficult 

but critical issues of who pays and how funding for biosurveillance will be 

sustained in the future. Finally, we noted that in an environment with 

competing priorities, a strategy could help address situations where 

investments must be carefully weighed and sound judgments made about 

the most cost-effective approaches, but doing so would require 

information about the cost, benefits, and risks associated with the whole 

biosurveillance enterprise.13

The National Strategy for Biosurveillance includes four guiding principles 

that are designed to serve as a foundation for enterprisewide efforts, four 

core functions that are designed to promote a deliberate and shared 

approach, and four enabling capabilities that are designed to represent 

areas for ongoing focus.14

 

13

These planks of the strategy align with our call 

for a strategy that would help to clarify the scope and purpose of a 

national biosurveillance capability and the goals of that capability. Our 

June 2010 report described several categories of federal efforts to 

improve the personnel, training, and systems and equipment that support 

a national capability. These included responding to workforce needs, 

facilitating information sharing, and applying technologies to enhance 

surveillance. Among the planks of the National Strategy for 

Biosurveillance, it is possible to discern support for each these 

categories. For example, the enabling capability called build capacity, 

discusses both workforce and information sharing issues. The four 

guiding principles that serve as the strategy’s foundation encourage 

broad-based and cross-cutting actions to leverage constrained resources, 

responding, in part, to our call for the strategy to help identify the 

resources currently being used, additional resources that may be needed, 

and opportunities for leveraging resources.

GAO-10-645. 

14The guiding principles articulated in the strategy are to (1) leverage existing capabilities, 

(2) embrace an all-of-Nation approach, (3) add value for all participants, and (4) maintain 

a global health perspective. The core functions are to (1) scan and discern the 

environment, (2) identify and integrate essential information, (3) inform and alert decision 

makers, and (4) forecast and advise about potential impacts. The enablers are to (1) 

integrate capabilities, (2) build capacity, (3) foster innovation, and (4) strengthen 

partnerships.
 

Page 13 GAO-12-994T 

However, the strategy does not yet offer a mechanism to identify resource 

and investment needs, including investment priorities among these 

various efforts. Accordingly, the enterprise is still without a framework to 

guide the systematic identification of risk, assessment of resources 

needed to address those risks, and the prioritization and allocation of 

investment across the entire biosurveillance enterprise, as we 

recommended in June 2010. For example, in the case of the broader 

contextual information needed to inform the BioWatch Gen-3 mission 

need, the strategy has language indicating that advances in science and 

technology are a priority. In fact, the capability enabler called fostering 

innovation specifically calls for science and technology capabilities, 

including new detection approaches. However, the strategy does not 

facilitate analysis or provide tools to assess the risks to be addressed—in 

the context of enterprisewide goals—by such science and technology 

approaches or the value they should offer the enterprise relative to their 

costs. Without such a framework and tool set, it remains difficult for 

decision makers—in both the executive and legislative branches—to help 

ensure that their resource allocation decisions contribute to a coherent 

enterprisewide approach.

We are encouraged by the National Strategy for Biosurveillance and the 

work the White House has done to date to provide a platform for 

achieving a well-integrated national biosurveillance enterprise. We are 

hopeful that the forthcoming strategic implementation plan which 

promises to include specific actions and activity scope, designated roles 

and responsibilities, and a mechanism for evaluating progress will help to 

address the ongoing need for mechanisms to help prioritize resource 

allocation.

Chairmen Bilirakis and Lungren, this concludes my prepared statement. I 

would be happy to respond to any questions you or the other committee 

members may have.

For further information on this testimony, please contact Bill Jenkins, 

(202) 512-8757 or by e-mail at jenkinswo@gao.gov. Contact points for 

our Offices of Congressional Relations and Public Affairs may be found 

on the last page of this statement. Other contributors include; Hal Brumm, 

Nirmal Chaudhary, Michelle Cooper, Edward George, Kathryn Godfrey, 

Allyson Goldstein, Tracey King, Amanda Miller, Jan Montgomery, Katy 

Trenholme, and Katherine Trimble.

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