BIOSURVEILLANCE

Observations on the 

Cancellation of BioWatch 

Gen-3 and Future 

Considerations for the 

Program

Statement of Chris Currie, Acting Director, 

Homeland Security and Justice

Testimony 

Before the Subcommittee on Emergency 

Preparedness, Response, and 

Communications, Committee on Homeland 

Security, House of Representatives

For Release on Delivery 

Expected at 10:00 a.m. ET

Tuesday, June 10, 2014

GAO-14-267T

United States Government Accountability Office
United States Government Accountability Office

Highlights of GAO-14-267T, a testimony 

before the Subcommittee on Emergency 

Preparedness, Response, and 

Communications; Committee on Homeland 

Security, House of Representatives 

June 10, 2014

BIOSURVEILLANCE

Observations on the Cancellation of BioWatch Gen-3 

and Future Considerations for the Program

Why GAO Did This Study

DHS’s BioWatch program aims to 

detect the presence of biological 

agents considered to be at a high risk 

for weaponized attack in major U.S. 

cities. Initially, development of a next 

generation technology (Gen-3) was led 

by DHS S&T, with the goal of 

improving upon currently deployed 

technology (Gen-2). Gen-3 would have 

potentially enabled collection and 

analysis of air samples in less than 6 

hours, unlike Gen-2 which can take up 

to 36 hours to detect and confirm the 

presence of biological pathogens. 

Since fiscal year 2007, OHA has been 

responsible for overseeing the 

acquisition of this technology. GAO 

has published a series of reports on 

biosurveillance efforts, including a 

report on DHS’s Gen-3 acquisition. 

In April 2014, DHS cancelled the 

acquisition of Gen-3 and plans to move 

development efforts of an affordable 

automated aerosol biodetection 

capability, or other enhancements to 

the BioWatch system to DHS S&T. 

This statement addresses (1) 

observations from GAO’s prior work on 

the acquisition processes for Gen 3, 

and the current status of the program;

(2) observations from GAO’s prior work 

related to DHS S&T and the impact it 

could have on the BioWatch program; 

and (3) future considerations for the

currently deployed Gen-2 system. 

This testimony is based on previous 

GAO reports issued from 2010 through 

2014 related to biosurveillance and 

research and development, and 

selected updates obtained from

January to June 2014. For these 

updates, GAO reviewed studies and 

documents and interviewed officials 

from DHS and the national labs, which 

have performed studies for DHS. 

What GAO Found

In September 2012, GAO reported that the Department of Homeland Security 

(DHS) approved the Office of Health Affairs (OHA) acquisition of a next 

generation biosurveillance technology (Gen-3) in October 2009 without fully 

following its acquisition processes. For example, the analysis of alternatives 

(AoA) prepared for the Gen-3 acquisition did not fully explore costs or consider 

benefits and risk information in accordance with DHS’s Acquisition Life-cycle 

Framework. To help ensure DHS based its acquisition decisions on reliable 

performance, cost, and schedule information, GAO recommended that before 

continuing the Gen-3 acquisition, DHS reevaluate the mission need and 

alternatives. DHS concurred with the recommendation and in 2012 decided to 

reassess mission needs and conduct a more robust AoA. Following the issuance

of the AoA in December 2013, DHS decided in April 2014 to cancel Gen-3 

acquisition and move the technology development back to the Science and 

Technology Directorate (S&T). According to DHS’s acquisition decisions 

memorandum, the AoA did not confirm an overwhelming benefit to justify the cost 

of a full technology switch to Gen-3. Moreover, DHS officials said the decision to 

cancel the Gen-3 acquisition was a cost-effectiveness measure, because the 

system was going to be too costly to develop and maintain in its current form.

GAO’s prior work on DHS research and development (R&D) highlights 

challenges DHS may face in shifting efforts back to S&T and acquiring another 

biodetection technology. In September 2012, GAO reported that while S&T had 

dozens of technology transition agreements with DHS components, none of 

these had yet resulted in a technology developed by S&T being used by a 

component. At the same time, other DHS component officials GAO interviewed 

did not view S&T’s coordination practices positively. GAO recommended that 

DHS develop and implement policies and guidance for defining and overseeing 

R&D at the department that includes a well-understood definition of R&D that 

provides reasonable assurance that reliable accounting and reporting of R&D 

resources and activities for internal and external use are achieved. S&T agreed 

with GAO’s recommendations and efforts to address them are ongoing.

Addressing these coordination challenges could help to ensure that S&T’s 

technology development efforts meet the operational needs of OHA.

Cancellation of the Gen-3 acquisition also raises potential challenges that the 

currently deployed Gen-2 system could face going forward. According to DHS

officials, DHS will continue to rely on its Gen-2 system as an early indicator of an 

aerosolized biological attack. However, in 2011, National Academy of Sciences 

raised questions about the effectiveness of the currently deployed Gen-2 system. 

While Gen-2 has been used in the field for over a decade, the National Academy 

of Sciences reported that information about the technical capabilities of the 

system, including the limits of detection, is limited. In April 2014, DHS officials 

also indicated that they will soon need to replace laboratory equipment of the 

currently deployed Gen-2 system and readjust life cycle costs since there will be 

no Gen-3 technology to replace it.

View GAO-14-267T. For more information, 

contact Chris Currie at (404) 679-1875, or 

curriec@gao.gov.
 

Page 1 GAO-14-267T 

Chairman Brooks, Ranking Member Payne, and Members of the 

Subcommittee:

I am pleased to be here today to discuss our observations on the 

Department of Homeland Security’s (DHS) BioWatch program, with 

particular focus on the cancellation of BioWatch Generation 3 (Gen-3) 

and future considerations for the program. In recent years, there has 

been an increasing awareness of the potential for biological agents to be 

used as weapons of mass destruction. Experts and practitioners, reacting 

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

biological weapon of mass destruction could affect the nation, have 

sought to augment traditional surveillance activities with biosurveillance 

programs and systems.1

DHS’s Office of Health Affairs (OHA) oversees the currently deployed 

BioWatch technology—Generation-2 (Gen-2) — which can take 12 to 36 

hours to confirm the presence of pathogens. Until recently, DHS had 

been pursuing a next generation technology (Gen-3) with the goal of 

improving upon existing technology by enabling autonomous collection 

and analysis of air samples using the same laboratory science that is 

carried out in manual processes to operate the current system (e.g., labin-a-box). The new technology would have reduced detection time, 

potentially generating a result in under 6 hours, and eliminated certain 

labor costs.

DHS’s BioWatch program is an example of such 

an effort. BioWatch 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.

This statement includes observations from our prior work (1) on DHS’s 

acquisition processes for Gen-3, and the current status of the program; 

(2) related to DHS’s Science and Technology Directorate (S&T) and the 

 

1

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. The National Strategy for Biosurveillance defines 

“biosurveillance” as the process of gathering, integrating, interpreting, and communicating 

essential information related to all-hazards 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-14-267T 

impact it could have on the BioWatch program; and (3) future 

considerations for the currently deployed Gen-2 system.

This testimony is based on our previous reports issued from 2010 through 

2014 related to biosurveillance, research and development, and 

acquisitions.2 For this work, 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. We also interviewed S&T leadership, technical division 

directors, and DHS component officials to discuss S&T and DHS’s 

research and development (R&D) coordination processes. More detailed 

information on our scope and methodology appears in the published 

reports. This statement is also based in part on selected updates we 

conducted in June 2013 and July 2013 related to DHS’s R&D efforts and 

its oversight of R&D efforts across the department and on selected 

updates related to the BioWatch program conducted from January to 

June 2014.3

 

2

GAO, Biosurveillance: Efforts to Develop a National Biosurveillance Capability Need a 

National Strategy and a Designated Leader, 

For updates on the BioWatch program, we analyzed studies 

and documents and interviewed knowledgeable officials at DHS and the 

national laboratories, which have performed testing and studies for DHS.

GAO-10-645 (Washington, D.C.: June 30, 

2010). GAO, Department of Homeland Security: Oversight and Coordination of Research 

and Development Should Be Strengthened, GAO-12-837 (Washington, D.C.: Sept.12, 

2012).GAO, Biosurveillance: Observations on BioWatch Generation-3 and Other Federal 

Efforts. GAO-12-994T (Washington, D.C., Sept. 2012). GAO-13-279SP. 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, Department of Homeland Security: Opportunities Exist to 

Strengthen Efficiency and Effectiveness, Achieve Cost Savings, and Improve 

Management Functions, GAO-13-547T (Washington, D.C.: April 26, 2013). GAO, 

Department of Homeland Security: Oversight and Coordination of Research and 

Development Efforts Could Be Strengthened, GAO-13-766T (Washington, D.C., July 17, 

2013). GAO, Canceled DOD Programs: DOD Needs to Better Use Available Guidance 

and Manage Reusable Assets, GAO-14-77 (Washington, D.C.: Mar. 27. 2014). GAO, 

Homeland Security: Acquisitions: DHS Could Better Manage Its Portfolio To Address 

Funding Gaps And Improve Communications With Congress, GAO-14-332, (Washington, 

D.C., April 2014).

3

GAO-13-766T. 
 

Page 3 GAO-14-267T 

We conducted the work upon which this statement is based and the 

selected updates 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. Additional details 

on our scope and methodology can be found in the individual products 

cited throughout this statement.

We have highlighted DHS acquisition management issues in our high-risk 

list since 2005.4 Over the past several years, our work has identified 

significant shortcomings in the department’s ability to manage an 

expanding portfolio of major acquisitions.5 We have also reported that 

while DHS acquisition policy reflects many key program management 

practices intended to mitigate the risks of cost growth and schedule slips, 

the department did not implement the policy consistently.6

 

4

GAO, High-Risk Series: An Update, 

In 2011, 

expressing concerns about whether DHS had undertaken a rigorous effort 

to help guide its Gen-3 decision making, members of Congress asked us 

to examine issues related to the Gen-3 acquisition. We released a report 

that evaluated the acquisition decision-making process for Gen-3 in 

GAO-05-207 (Washington, D.C.: January 2005).

5

For examples, see GAO, Homeland Security: DHS Requires More Disciplined Investment 

Management to Help Meet Mission Needs, GAO-12-833 (Washington, D.C.: Sept. 18, 

2012); Department of Homeland Security: Assessments of Selected Complex 

Acquisitions, GAO-10-588SP (Washington, D.C.: June 30, 2010); and Department of 

Homeland Security: Billions Invested in Major Programs Lack Appropriate Oversight, 

GAO-09-29 (Washington, D.C.: Nov. 18, 2008).

6

GAO, Department Of Homeland Security: Progress Made; Significant Work Remains in 

Addressing High-Risk Areas, GAO-14-532T (Washington, D.C.: May 7, 2014). The 

reference to DHS acquisition policy, for purposes of this testimony, consists of 

Management Directive (ADM) 102-01, and an associated guidebook. The overall policy 

and structure for acquisition management outlined in DHS’s AMD 102-01 includes the 

department’s Acquisition Life-cycle Framework—a template for planning and executing 

acquisitions. DHS’s Acquisition Life-cycle Framework includes four acquisition phases 

through which DHS determines whether it is sensible to proceed with a proposed 

acquisition: (1) identify a capability need; (2) analyze and select the optimal solution to 

meet that need; (3) obtain the solution; and (4) produce, deploy, and support the solution.

Background

DHS Acquisitions and the 

Cancellation of Gen-3
 

Page 4 GAO-14-267T 

September 2012.7 As discussed later in the statement, we recommended 

that before continuing the Gen-3 acquisition, DHS should carry out key 

acquisition steps, including reevaluating the mission need and 

systematically analyzing alternatives based on cost-benefit and risk 

information. 8

On April 24, 2014, DHS issued an Acquisition Decision Memo (ADM) 

announcing the cancellation of the acquisition of Gen-3.9 The ADM also 

announced that S&T will explore development and maturation of an 

effective and affordable automated aerosol biodetection capability, or 

other operational enhancements, that meet the operational requirements 

of the BioWatch system.10 DHS’s S&T conducts research, development, 

testing, and evaluation of new technologies that are intended to 

strengthen the United States’ ability to prevent and respond to nuclear, 

biological, explosive, and other types of attacks within the United States. 

S&T has six technical divisions responsible for managing S&T’s research 

R&D portfolio and coordinating with other DHS components to identify 

R&D priorities and needs.11 Most of S&T’s R&D portfolio consists of 

applied research and development projects for its DHS customers.

 

7

GAO-12-810.

8

The Gen-3 acquisition was in the early stages of Phase 3 (obtain the solution) when the

acquisition was placed on hold.

9

An Acquisition Decision Memo (ADM) is the official record of the Acquisition Decision 

Event and describes the decisions made and any action items to be satisfied as conditions 

of the decision made by the Acquisition Review Board.

10DHS began to develop autonomous detection technology in 2003. Initially, development 

of technologies to support autonomous detection was led by DHS’s S&T, which partnered 

with industry. Since fiscal year 2007, DHS’s OHA has been responsible for overseeing the 

acquisition of this technology.

11These divisions are the Borders and Maritime Division, Chemical/Biological Defense 

Division, Cyber Security Division, Explosives Division, Human Factors/ Behavioral 

Sciences Division, and the Infrastructure Protection and Disaster Management Division. In 

addition, S&T’s First Responder Group (FRG) identifies, validates, and facilitates the 

fulfillment of first responder requirements through the use of existing and emerging 

technologies, knowledge products, and the development of technical standards, according 

to S&T FRG officials. 
 

Page 5 GAO-14-267T 

The BioWatch program collaborates with 30 BioWatch jurisdictions 

throughout the nation to operate approximately 600 Gen-2 collectors. 

These detectors rely on a vacuum-based collection system that draws air 

samples through a filter. These filters must be manually collected and 

transported to state and local public health laboratories for analysis using 

a process called Polymerase Chain Reaction (PCR). During this process, 

the sample is evaluated for the presence of genetic material from five 

different biological agents. If genetic material is detected, a BioWatch 

Actionable Result (BAR) is declared. Figure 1 shows the process that 

local BioWatch jurisdictions are to follow when deciding how to respond to 

a BAR.12

 

12The BioWatch program defines a BAR as one or more Polymerase Chain Reaction 

(PCR)-verified positive results from a single BioWatch collector. A positive result requires 

multiple strands of the PCR-amplified DNA to match an algorithm that has been designed 

to indicate the presence of genetic material from one or more of the agents in question.

BioWatch in Action
 

Page 6 GAO-14-267T 

Figure 1: Process Used By Jurisdictions to Detect and Respond to a BioWatch Actionable Result

a

PCR is a technique to copy DNA for laboratory testing.

b

The BioWatch program defines a BAR as one or more PCR-verified positive results from a single

BioWatch collector. A positive result requires multiple strands of the PCR-amplified DNA to match an

algorithm that has been designed to indicate the presence of genetic material from one or more of the

five agents in question.
 

Page 7 GAO-14-267T 

Our prior findings and recommendations related to the Gen-3 acquisition 

provide DHS with lessons learned for future decision making. In 

September 2012, we found that 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, we 

found that DHS did not engage the initial phase of its Acquisition Lifecycle Framework, which is designed to help ensure that the mission need 

driving the acquisition warrants investment of limited resources.13

Additionally, in September 2012, we found that 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 (AoA) 

that systematically identifies possible alternative solutions that could 

satisfy the identified need, considers cost-benefit and risk information for 

each alternative, and finally selects the best option from among the 

alternatives. However, we found that the AoA 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 a 

predetermined solution from the Mission Needs Statement, the AoA did 

not fully explore costs or consider benefits and risk information as part of 

the analysis. Instead, the AoA focused on just one cost metric that 

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, we concluded that the utility of the Mission Needs 

Statement as a foundation for subsequent acquisition efforts was limited.

 

13According 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.

Our Prior Work on the 

Gen-3 Acquisition 

Identified Challenges 

and DHS Has Since 

Cancelled the 

Program
 

Page 8 GAO-14-267T 

justified the decision to pursue autonomous detection—cost per detection 

cycle—to the exclusion of other cost and benefit considerations that might 

have further informed decision makers.14

As we reported in September 2012, BioWatch program officials 

acknowledged that other options—including but not limited to deploying 

some combination of both technologies (the currently deployed system 

and an autonomous detection system), 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 AoA would not be necessary because there was already 

departmental consensus that autonomous detection was the optimal 

solution. Because the Gen-3 AoA did not: evaluate a complete solution 

set; consider complete information on cost and benefits; and include a 

cost-benefit analysis, we concluded that it did not provide information on 

which to base trade-off decisions.

Additionally, we found that the 

AoA examined only two alternatives, though the 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.

To help ensure DHS based its acquisition decisions on reliable 

performance, cost, and schedule information developed in accordance 

with guidance and good practices, in our September 2012 report, we 

recommended that before continuing the Gen-3 acquisition, DHS 

reevaluate the mission need and possible alternatives based on costbenefit and risk information. DHS concurred with the recommendation 

and in 2012, DHS directed the BioWatch program to complete an updated 

AoA.15

 

14Cost 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.

15According to DHS’s Acquisition Life-cycle Framework, an Analysis of Alternatives 

systematically identifies possible alternative solutions that could satisfy the identified need, 

considers cost-benefit and risk information for each alternative, and finally selects the best 

option from among the alternatives.
 

Page 9 GAO-14-267T 

DHS contracted with the Institute for Defense Analyses (IDA) to conduct 

the updated AoA, which they issued in December 2013. In January 2014, 

as part of recommendation follow-up, we reviewed the completed 

analysis. IDA cited the DHS Acquisition Management 

Instruction/Guidebook and its appendix on conducting an AoA as the 

criteria for their study. The management directive lays out a sample 

framework that details the specific steps to take in evaluating acquisition 

alternatives, which the contractor used for completing its study. On the 

basis of our review, we concluded that the IDA-conducted AoA followed 

the DHS guidance and resulted in a more robust exploration of 

alternatives than the previous effort. The AoA was not intended to identify 

a specific solution to address DHS’s requirements for earlier warning and 

detection capabilities. According to IDA, the AoA does not claim to select 

a solution, but rather to present alternatives and the information required 

to select an alternative based on cost and effectiveness trade-offs.

On April 24, 2014, the DHS Acquisition Review Board reviewed the 

BioWatch Gen-3 acquisition with OHA and issued an ADM announcing 

the cancellation of the acquisition of Gen-3. According to the DHS ADM, 

the AoA “did not confirm an overwhelming benefit to justify the cost of a 

full technology switch” to Gen-3. The ADM also announced that S&T will 

explore development and maturation of an effective and affordable 

automated aerosol biodetection capability, or other operational 

enhancements, that meet the operational requirements of the BioWatch 

system. 

In April 2014, BioWatch Program officials said multiple factors influenced 

the decision to end the Gen-3 acquisition, including budget 

considerations, considerations regarding the readiness level of the 

technology, and the cost to field and maintain the technology. BioWatch 

Program officials said that the Homeland Security Studies and Analysis 

Institute’s and our recommendations to complete a robust AoA, which 

resulted in not identifying a clear path forward for a single technology type 

for the Gen-3 acquisition, was also a contributing factor. According to 

BioWatch Program officials, DHS has not ruled out the possibility of 

pursuing autonomous detection for the BioWatch program, but officials 

said the technology would have to cost less to develop and maintain than 

was estimated for the Gen-3 system.
 

Page 10 GAO-14-267T 

Earlier this year, we reported that when programs have been canceled, 

cost, schedule, and performance problems have often been cited as 

reasons for this decision, and cancellation can be perceived as failure.16

However, in some circumstances, program cancellation may be the best 

choice. In an April 2014 interview, BioWatch Program officials said the 

Gen-3 acquisitions process yielded many benefits, despite its 

cancellation. BioWatch Program officials said the program office has 

learned and gained much from this experience, including engaging state 

and local stakeholders to help ensure confidence in the system and 

BioWatch program; finding better ways to test technologies and refine the 

Testing and Evaluation guidance; and developing robust acquisition 

documentation for the department. BioWatch program officials said the 

decision to cancel the Gen-3 acquisition was a cost-effectiveness 

measure, because the system was going to be too costly to develop and 

maintain in its current form. We reported in 2012 that while the DHS June 

2011 life-cycle cost estimate reported $104 million in actual and 

estimated costs from fiscal year 2008 through fiscal year 2011, it also 

indicated that Gen-3 was expected to cost $5.8 billion (80 percent 

confidence) from fiscal year 2012 through June 2028. However, the 

original life-cycle cost estimate for the 2009 decision—a point estimate 

unadjusted for risk—was $2.1 billion.17

DHS has taken positive steps as we recommended to complete a robust 

assessment of the available biodetection technology alternatives and has 

taken into consideration the cost and readiness level of the current 

technology. However, our prior work reviewing DHS research and 

development efforts highlights challenges DHS may face in transitioning 

the future biodetection development efforts S&T is now charged with 

exploring back to the program office, OHA. For example, S&T works with 

DHS components to ensure that it meets their R&D needs by signing 

technology transition agreements (TTA) to ensure that components use 

 

16GAO-14-77. 

17We reported in 2012 that this point estimate was not completed in accordance with the 

GAO Cost Estimating Guide, which DHS uses for cost estimating to help ensure the 

reliability of its cost estimates. According to the Guide, a point estimate, by itself, provides 

no information about the underlying uncertainty other than that it is the value chosen as 

most likely. A confidence interval, in contrast, provides a range of possible costs, based 

on a specified probability level. See, GAO, Cost Estimating and Assessment Guide, 

GAO-09-3SP (Washington, D.C.: Mar. 2, 2009).

DHS R&D Efforts Also 

Face Challenges that 

Could Impact the 

BioWatch Program
 

Page 11 GAO-14-267T 

the technologies S&T develops. However, we previously reported in 

September 2012 that while S&T had 42 TTAs with DHS components, 

none of these TTAs has yet resulted in a technology being transitioned 

from S&T to a component.18

We also reported in 2012 that OHA, which oversees operation of the 

BioWatch program, and S&T already had a history of working together on 

advancing the technology used by the BioWatch program.

In that review we also found that other DHS 

component officials we interviewed did not view S&T’s coordination 

practices positively. Specifically, we interviewed officials in six 

components to discuss the extent to which they coordinated with S&T on 

R&D activities. Officials in four components stated that S&T did not have 

an established process that detailed how S&T would work with its 

customers or for coordinating all activities at DHS. For example, officials 

in one component stated that S&T has conducted R&D that it thought 

would address the component’s operational need but, when work was 

completed, the R&D project did not fit into the operational environment to 

meet the component’s needs.

19

In our September 2012 report, we concluded that DHS and S&T could be 

in a better position to coordinate the department’s R&D efforts by 

implementing a specific policy outlining R&D roles, responsibilities, and 

However, 

differences of opinion on key performance measures had created a 

challenge for these two offices related to future biodetection technologies. 

For example, during our 2012 review of the Gen-3 acquisition, officials 

from OHA said both OHA and S&T commissioned the Sandia National 

Laboratory to conduct similar studies on the performance characteristics 

of the Gen-3 autonomous detection system, but the two offices requested 

the use of different performance metrics to evaluate Gen-3’s detection 

capability. OHA officials said they supported using the fraction of the 

population covered as the metric because it is directly related to public 

health outcomes, while S&T preferred to use the probability of detection. 

While we recognize there are advantages and disadvantages for 

choosing different performance metrics, technology transition of the R&D 

project developed by S&T could prove challenging in the future if 

fundamental differences like this are not resolved early to help ensure the 

technology meets the operational needs of the program office.

 

18GAO-12-837

19GAO-12-810
 

Page 12 GAO-14-267T 

processes for coordinating R&D. As a result, we recommended that DHS 

develop and implement policies and guidance for defining and overseeing 

R&D at the department-level that includes a well-understood definition of 

R&D that provides reasonable assurance that reliable accounting and 

reporting of R&D resources and activities for internal and external use are 

achieved. DHS agreed with our recommendation, and in April 2014, 

updated its guidance to include a definition of R&D, but efforts to develop 

a specific policy outlining R&D roles and responsibilities and a process for 

coordinating R&D with other offices remain ongoing and have not yet 

been completed.20

With the cancellation of the Gen-3 acquisition, DHS will continue to rely 

on its currently deployed Gen-2 system as an early indicator of an 

aerosolized biological attack. Cancellation of the Gen-3 system also 

raises questions that need to be answered about the future maintenance 

of the Gen-2 system, since it will no longer be replaced, as planned.

According to program officials that we recently contacted, DHS is 

considering multiple options to upgrade the current technology to improve 

detection capabilities in the wake of the Gen-3 acquisition cancellation. In 

April 2014, program officials described some of the options they are 

considering to upgrade the currently deployed system, including:

• The addition of a trigger to the current system to enhance 

performance indoors. These are generally systems that provide very 

fast but nonspecific warnings of a potential agent release, because 

they do not identify the type of biological material detected. However, 

DHS is exploring how to use a trigger to indicate when an air sample 

should be collected and taken to the laboratory for analysis.

• Use of a wet or liquid filter system rather than the current dry filter 

system. Collecting samples directly into a liquid could also increase 

the odds that any microorganisms would remain alive for subsequent 

testing.

• Increased frequency of manual filter collection and testing, which 

would likely increase costs.

• Other options for hand-held or portable detection devices.

 

20The DHS Delegation to the Under Secretary for Science and Technology, DHS 

Delegation Number: 10001, Revision Number: 01, Annex A includes the definition for 

research and development.

Future 

Considerations for the 

Currently Deployed 

Gen-2 system
 

Page 13 GAO-14-267T 

While OHA officials determine the next steps with S&T for the BioWatch 

program to try and address the capability gap that Gen-3 intended to fill, 

there are other considerations for the currently deployed system, such as 

maintainability of the current technology and equipment and the costs 

associated with any upgrades to extend the life of the existing system.

For example, BioWatch program officials indicated they will need to 

replace the laboratory equipment for the currently deployed system, as 

early as 2015, and readjust life cycle costs.21

Further, while Gen-2 has been used in the field for over a decade, 

information about the technical capabilities for the Gen-2 system, 

including the limits of detection, is limited. In 2011, the National Academy 

of Sciences stated that the rapid initial deployment of BioWatch did not 

allow for sufficient testing, validation, and evaluation of the system and its 

components.22

Our prior work has also highlighted the uncertainty about the incremental 

benefit of this kind of environmental monitoring as a risk mitigation activity 

because of its relatively limited scope and the challenges agencies face in 

making these investment decisions. In our June 2010 report on federal 

biosurveillance efforts, we recommended the Homeland Security Council 

direct the National Security Staff to identify a focal point to lead the 

development of a national biosurveillance strategy. We made this 

recommendation because we recognized the difficulty that decision 

makers and program managers in individual federal agencies face 

The 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. Further, the report also stated that to achieve its 

health protection goals, the BioWatch system should be better linked to a 

broader and more effective national biosurveillance framework that will 

help provide state and local public health authorities, in collaboration with 

the health care system, with the information they need to determine the 

appropriate response to a possible or confirmed attack or disease 

outbreak.

 

21The Consolidated Appropriations Act, 2014, appropriated the Office of Health Affairs $85 

million for BioWatch operations. Pub. L. No. 113-76, 128 Stat. 5, 260. 

22See Institute of Medicine and National Research Council, BioWatch and Public Health 

Surveillance, 2011.
 

Page 14 GAO-14-267T 

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.23 In July 2012, the 

White House released the National Strategy for Biosurveillance to 

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

biosurveillance, but it does not fully meet the intent of our prior 

recommendations, because it does not yet offer a mechanism to identify 

resource and investment needs, including investment priorities among 

various biosurveillance efforts. We remain hopeful that the forthcoming 

strategic implementation plan which was supposed to be issued in 

October 2012 and promised 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 that will 

help prioritize resource allocation. However, as of March 14, 2014 the 

implementation plan had not been released.

Chairman Brooks, Ranking Member Payne, and members of the 

subcommittee, this concludes my prepared statement. I would be happy 

to respond to any questions you may have.

If you or your staff members have any questions about this testimony, 

please contact me 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. Other contributors include; 

Edward George, Kathryn Godfrey, Eric Hauswirth, Susanna Kuebler, and 

Linda Miller.

 

23GAO-10-645.

GAO Contacts and 

Staff 

Acknowledgements

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