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BIOWATCH: LESSONS LEARNED AND THE PATH 

FORWARD 

HEARING 

BEFORE THE

SUBCOMMITTEE ON EMERGENCY 

PREPAREDNESS, RESPONSE, 

AND COMMUNICATIONS 

OF THE

COMMITTEE ON HOMELAND SECURITY 

HOUSE OF REPRESENTATIVES 

ONE HUNDRED THIRTEENTH CONGRESS 

SECOND SESSION 

JUNE 10, 2014 

Serial No. 113–70 

Printed for the use of the Committee on Homeland Security 

Available via the World Wide Web: http://www.gpo.gov/fdsys/ 
(II) 

COMMITTEE ON HOMELAND SECURITY 

MICHAEL T. MCCAUL, Texas, Chairman 

LAMAR SMITH, Texas 

PETER T. KING, New York 

MIKE ROGERS, Alabama 

PAUL C. BROUN, Georgia 

CANDICE S. MILLER, Michigan, Vice Chair 

PATRICK MEEHAN, Pennsylvania 

JEFF DUNCAN, South Carolina 

TOM MARINO, Pennsylvania 

JASON CHAFFETZ, Utah 

STEVEN M. PALAZZO, Mississippi 

LOU BARLETTA, Pennsylvania 

RICHARD HUDSON, North Carolina 

STEVE DAINES, Montana 

SUSAN W. BROOKS, Indiana 

SCOTT PERRY, Pennsylvania 

MARK SANFORD, South Carolina 

VACANCY

BENNIE G. THOMPSON, Mississippi 

LORETTA SANCHEZ, California 

SHEILA JACKSON LEE, Texas 

YVETTE D. CLARKE, New York 

BRIAN HIGGINS, New York 

CEDRIC L. RICHMOND, Louisiana 

WILLIAM R. KEATING, Massachusetts 

RON BARBER, Arizona 

DONDALD M. PAYNE, JR., New Jersey 

BETO O’ROURKE, Texas 

FILEMON VELA, Texas 

ERIC SWALWELL, California 

VACANCY

VACANCY

BRENDAN P. SHIELDS, Staff Director 

MICHAEL GEFFROY, Deputy Staff Director/Chief Counsel 

MICHAEL S. TWINCHEK, Chief Clerk 

I. LANIER AVANT, Minority Staff Director 

SUBCOMMITTEE ON EMERGENCY PREPAREDNESS, RESPONSE, AND 

COMMUNICATIONS 

SUSAN W. BROOKS, Indiana, Chairwoman 

PETER T. KING, New York 

STEVEN M. PALAZZO, Mississippi, Vice Chair 

SCOTT PERRY, Pennsylvania 

MARK SANFORD, South Carolina 

MICHAEL T. MCCAUL, Texas (ex officio) 

DONALD M. PAYNE, JR., New Jersey 

YVETTE D. CLARKE, New York 

BRIAN HIGGINS, New York 

BENNIE G. THOMPSON, Mississippi (ex officio) 

ERIC B. HEIGHBERGER, Subcommittee Staff Director 

DEBORAH JORDAN, Subcommittee Clerk 
(III) 

C O N T E N T S 

Page 

STATEMENTS

The Honorable Susan W. Brooks, a Representative in Congress From the 

State of Indiana, and Chairwoman, Subcommittee on Emergency Preparedness, Response, and Communications: 

Oral Statement ..................................................................................................... 1 

Prepared Statement ............................................................................................. 2 

The Honorable Donald M. Payne, Jr., a Representative in Congress From 

the State of New Jersey, and Ranking Member, Subcommittee on Emergency Preparedness, Response, and Communications: 

Oral Statement ..................................................................................................... 3 

Prepared Statement ............................................................................................. 4 

The Honorable Bennie G. Thompson, a Representative in Congress From 

the State of Mississippi, and Ranking Member, Committee on Homeland 

Security: 

Prepared Statement ............................................................................................. 4 

WITNESSES

Dr. Kathryn Brinsfield, Acting Assistant Secretary, Office of Health Affairs, 

U.S. Department of Homeland Security: 

Oral Statement ..................................................................................................... 7 

Joint Prepared Statement ................................................................................... 9 

Dr. Reginald Brothers, Under Secretary, Science and Technology Directorate, 

U.S. Department of Homeland Security: 

Oral Statement ..................................................................................................... 12 

Joint Prepared Statement ................................................................................... 9 

Mr. Chris Cummiskey, Acting Under Secretary, Management Directorate, 

U.S. Department of Homeland Security: 

Oral Statement ..................................................................................................... 14 

Prepared Statement ............................................................................................. 15 

Mr. Chris Currie, Acting Director, Homeland Security and Justice Issues, 

U.S. Government Accountability Office: 

Oral Statement ..................................................................................................... 18 

Prepared Statement ............................................................................................. 19 

Dr. Deena S. Disraelly, Research Staff, Strategy, Forces, and Resources Division, Institute for Defense Analyses: 

Oral Statement ..................................................................................................... 27 

Prepared Statement ............................................................................................. 29 

APPENDIX

Questions From Chairwoman Susan W. Brooks for Kathryn Brinsfield and 

Reginald Brothers ................................................................................................ 55 

Questions From Chairwoman Susan W. Brooks for Kathryn Brinsfield ............ 57 

Questions From Chairwoman Susan W. Brooks for Chris Cummiskey .............. 59 

(1) 

BIOWATCH: LESSONS LEARNED AND THE 

PATH FORWARD 

Tuesday, June 10, 2014 

U.S. HOUSE OF REPRESENTATIVES, 

SUBCOMMITTEE ON EMERGENCY PREPAREDNESS, 

RESPONSE, AND COMMUNICATIONS, 

COMMITTEE ON HOMELAND SECURITY, 

Washington, DC. 

The subcommittee met, pursuant to call, at 10:03 a.m., in Room 

311, Cannon House Office Building, Hon. Susan W. Brooks [Chairwoman of the subcommittee] presiding. 

Present: Representatives Brooks, Palazzo, Sanford, and Payne. 

Mrs. BROOKS. Good morning. The Subcommittee on Emergency 

Preparedness, Response, and Communications will come to order. 

The subcommittee is meeting today to receive testimony regarding 

the Department of Homeland Security’s BioWatch program. 

The BioWatch program was established in 2003 in the aftermath 

of the anthrax attacks that killed 5 people and sickened more than 

20 others. The program is a system of detectors deployed to more 

than 30 U.S. cities to scan for a number of aerosolized biothreat 

agents. 

Recognizing the limitations of the current system, in 2008 the 

Department’s Office of Health Affairs began the process to acquire 

a next-generation detector known as Gen–3. After a series of 

missteps spanning two administrations, 6 years, and millions of 

dollars later, Secretary Johnson recently canceled that acquisition 

on April 29, 2014. 

We know through the subcommittee’s biothreat hearing in February and a subsequent Classified briefing that the threat of bioterrorism is real. In fact, in its BioWatch analysis of alternatives 

performed for the Department, the Institute for Defense Analyses 

noted that the bioterrorism threat has not changed since 2001. 

With that in mind, robust biosurveillance and biodetection capabilities are vital to our country’s security. I am interested in hearing from Dr. Brinsfield and Dr. Brothers about their efforts to work 

together going forward to develop, test, and deploy a next-generation technology. 

I am also interested in learning more about efforts to enhance 

the currently deployed system to make it more effective as we 

await new technology, and about the Department’s overall biosecurity strategy. 

In July 2012, the administration released its National Strategy 

for Biosurveillance. This strategy was supposed to be followed 120 
2 

days later by an implementation plan. However, nearly 2 years 

later, that plan has still not yet been completed. 

This is simply unacceptable. I hope our witnesses will be able to 

shed some light on the administration’s strategy and when that implementation plan will be complete. 

As we consider what is next for BioWatch, we must be mindful 

of what went wrong with Gen–3 so we learn from those mistakes. 

Unfortunately, this is not the first failed acquisition in the Department’s history. 

SBInet and others have suffered from management shortcomings, be they requirement settings or a failure to follow proper 

acquisition protocols, such as the completion of alternatives analyses or cost-benefit analyses. 

We can’t afford to waste a single dollar of Homeland Security 

funding. I am interested in hearing from Secretary Cummiskey on 

the Department’s efforts to mature its acquisition system and oversight of large-scale acquisitions, such as Gen–3. 

It is my hope that the acquisition legislation introduced by my 

colleague, Mr. Duncan of South Carolina, which the House just 

passed yesterday, will help to strengthen the Department’s acquisitions management capabilities. 

With that, I look forward to hearing from our distinguished panel 

of witnesses and to continuing the subcommittee’s examination of 

the bioterrorism threat facing our country, and our programs and 

capabilities to address that threat. 

The Chairman now recognizes the gentleman from New Jersey, 

Mr. Payne, for any opening statement he may have. 

[The statement of Chairwoman Brooks follows:] 

JUNE 10, 2014 

STATEMENT OF CHAIRWOMAN SUSAN W. BROOKS

The BioWatch program was established in 2003 in the aftermath of the anthrax 

attacks that killed 5 people and sickened more than 20 others. The program is a 

system of detectors deployed to more than 30 U.S. cities to scan for a number of 

aerosolized biothreat agents. 

Recognizing the limitations of the current system, in 2008 the Department’s Office 

of Health Affairs began the process to acquire a next generation detector, known 

as Gen–3. After a series of missteps spanning two administrations, 6 years, and millions of dollars later, Secretary Johnson cancelled that acquisition on April 29, 2014. 

We know, through this subcommittee’s biothreat hearing in February and a subsequent Classified briefing, that the threat of bioterrorism is real. In fact, in its 

BioWatch analysis of alternatives performed for the Department, the Institute for 

Defense Analysis noted that the bioterrorism threat has not changed since 2001. 

With that in mind, robust biosurveillance and biodetection capabilities are vital 

to our security. I am interested in hearing from Dr. Brinsfield and Dr. Brothers 

about their efforts to work together going forward to develop, test, and deploy a next 

generation technology. 

I am also interested in learning more about efforts to enhance the currently deployed system to make it more effective as we await new technology and about the 

Department’s overall biosecurity strategy. 

In July 2012, the administration released its National Strategy for Biosurveillance. This strategy was supposed to be followed, 120 days later, by an implementation plan. Nearly 2 years later, that plan has still not been completed. This is simply unacceptable. I hope our witnesses will be able to shed some light on the administration’s strategy and when that implementation plan will be complete. 

As we consider what is next for BioWatch, we must be mindful of what went 

wrong with Gen–3 so we learn from those mistakes. Unfortunately, this is not the 

first failed acquisition in the Department’s history. SBI–Net, the A–S–P program, 

e-Merge, and TASC all suffered from management shortcomings, be it requirements 
3 

setting, or a failure to follow proper acquisition protocols, such as the completion 

of alternatives analyses or cost benefit analyses. 

We cannot afford to waste a single dollar of security funding. I am interested in 

hearing from Secretary Cummiskey about the Department’s efforts to mature its acquisitions system and oversight of large-scale acquisitions, such as Gen–3. It is my 

hope that the acquisitions legislation introduced by my colleague, Mr. Duncan of 

South Carolina, which the House passed just last night, will help to strengthen the 

Department’s acquisitions management capabilities. 

With that, I look forward hearing from our distinguished panel of witnesses and 

to continuing the subcommittee’s examination of the bioterrorism threat and our 

programs and capabilities to address it. 

Mr. PAYNE. Good morning. I would like to thank Chairwoman 

Brooks for holding today’s hearing on the cancellation of BioWatch 

Gen–3 acquisition and the future of biosurveillance and detection. 

The Department of Homeland Security’s decision to cancel the 

BioWatch Gen–3 acquisition raises several questions, but I think 

they can be boiled down to two. 

First, if Gen–3 is canceled, what are we going to do instead? Second, with about $100 million already appropriated to the canceled 

Gen–3 acquisition, what efforts is DHS undertaking to make sure 

that acquisition decisions are made more responsibly in the future? 

To the first question, I understand that the current budgetary 

constraints contributed significantly to the Department’s decision 

to cancel the Gen–3 acquisition. I appreciate DHS’s efforts to reconcile the findings of the analysis of alternatives, BioWatch detection goals, and existing fiscal limitations. 

I trust that the Secretary’s decision, though difficult, was informed, thoughtful, and deliberate. 

But the threat posed by biological weapons remains. 

In February, as stated, this subcommittee held a hearing on bioterrorism and each witness had the same message—the threat 

posed by biological weapons still exists, and the consequences of 

such an attack would be devastating if we could not identify and 

quickly respond. 

Accordingly, I would be interested to know what and how DHS 

will ensure that it is maximizing the limited resources to ensure 

that our biodetection and surveillance capabilities address the 

threats identified by the intelligence community. 

Turning to the broader acquisition issue, I note that in addition 

to serving as Ranking Member on this panel, I sit on the Subcommittee on Oversight and Management Efficiency. Over the past 

year-and-a-half, that panel has devoted a significant amount of 

time to overseeing DHS’s efforts to improve acquisition management, which has been on the Government Accountability Office’s 

high-risk list since 2005. 

Although I understand that some progress has been made to get 

acquisition management off the high-risk list, it continues to remain to be a challenge. 

Indeed, the acquisition process for BioWatch Gen–3 embodied 

many of the problems that plagued previous acquisitions—cost 

overruns, delayed deployment, and insufficient documentation to 

support the investment. 

I commend DHS for obtaining a thorough analysis of alternatives 

and other preliminary acquisition documents, and for using those 

documents to assess the future of Gen–3. 
4 

That said, I am concerned that those foundational documents 

were not completed until 7 years after the BioWatch Gen–3 acquisition process began. 

I would be interested to learn from the Department how it will 

use the lessons learned from the BioWatch Gen–3 acquisition to 

strengthen its acquisition policies. 

I thank the witnesses for being here today and I look forward to 

your testimony. With that, Madam Chairwoman, I yield back the 

balance of my time. 

[The statement of Ranking Member Payne follows:] 

STATEMENT OF RANKING MEMBER DONALD M. PAYNE, JR. 

JUNE 10, 2014 

The Department of Homeland Security’s decision to cancel the BioWatch Gen–3 

acquisition raises several questions, but I think that they can be boiled down to two. 

First, if Gen–3 is canceled, what are we going to do instead? Second, with about 

$100 million already appropriated to the cancelled Gen–3 acquisition, what efforts 

is DHS undertaking to make sure that acquisition decisions are made more responsibly in the future? 

To the first question, I understand that current budgetary constraints contributed 

significantly to the Department’s decision to cancel the Gen–3 acquisition. I appreciate DHS’s efforts to reconcile the findings of the Analysis of Alternatives, biodetection goals, and existing fiscal limitations. And I trust that the Secretary’s decision— 

though difficult—was informed, thoughtful, and deliberate. 

But the threat posed by biological weapons remains. In February, this subcommittee held a hearing on bioterrorism. Each witness had the same message: The 

threat posed by biological weapons still exists and the consequences of such an attack would be devastating if we cannot identify it quickly and respond. 

Accordingly, I will be interested to know what how DHS will ensure that it is 

maximizing limited resources to ensure that our biodetection and surveillance capabilities address the threats identified by the intelligence community. 

Turning to the broader acquisition issue, I note that in addition to serving as 

Ranking Member on this panel, I sit on the Subcommittee on Oversight and Management Efficiency. Over the past year-and-a-half, that panel has devoted a significant amount of time to overseeing DHS’ efforts to improve acquisition management, 

which has been on the Government Accountability Office’s High-Risk List since 

2005. Although I understand that some progress has been made to get acquisition 

management off the High-Risk List, it continues to remain a challenge. 

Indeed, the acquisition process for BioWatch Gen–3 embodied many of the problems that plagued previous acquisitions: Cost overruns, delayed deployment, and insufficient documentation to support the investment. I commend DHS for obtaining 

a thorough Analysis of Alternatives and other preliminary acquisition documents 

and for using those documents to inform the future of Gen–3. 

That said, I am concerned that those foundational documents were not completed 

until nearly 7 years after the BioWatch Gen–3 acquisition process began. I will be 

interested to learn from the Department how it will use the lessons learned from 

the BioWatch Gen–3 acquisition to strengthen its acquisition policies. 

Mrs. BROOKS. Thank you. 

Other Members are reminded that statements may be submitted 

for the record. 

[The statement of Ranking Member Thompson follows:] 

STATEMENT OF RANKING MEMBER BENNIE G. THOMPSON

JUNE 10, 2014 

Nearly 2 years ago, this subcommittee held a hearing on acquisition failures that 

occurred as the Department of Homeland Security pursued BioWatch Gen–3. In addition to the problems with acquisition practices, Gen–3 was wrought with cost-overruns and technical challenges at the time. 
5 

Accordingly, at that hearing, Members of this panel urged DHS to suspend acquisition activities until it completed and assessed foundational acquisition documents 

per the recommendations of the Government Accountability Office. 

I am pleased that the Department heeded the advice of the GAO and our Members. The Department’s action resulted in the completion of a thorough Analysis of 

Alternatives, and the time necessary to process the findings and determine the best 

path forward. Given the challenges the Department has experienced with acquisitions in the past, I have consistently urged it to suspend acquisition immediately 

when problems exist so it can re-evaluate. 

I commend the Department for doing that here. Although nearly $100 million has 

already been appropriated to Gen–3, the Department’s decision to slow down and 

act deliberately will save taxpayer dollars in the long-run. 

That said, I echo concerns made by other members of this panel about the timing 

of the Analysis of Alternatives. I was also troubled to learn that there may have 

been alternative biodetection technologies used by other Federal agencies at the 

time acquisition for Gen–3 began, but it does not appear that DHS considered 

adapting those technologies instead of spending millions to develop its own. 

I will be interested in learning whether DHS will consider biodetection technology 

currently used by other Federal agencies or other off-the-shelf technologies. 

I am also interested in learning more about the status of currently-deployed 

BioWatch technology, and any challenges it faces. For example, I understand that 

much of the air sample and laboratory equipment may be reaching the end of their 

life cycle, and that some of the diagnostic technology is outdated. 

How will DHS address those issues, and does it have the resources to carry out 

the system upgrades necessary to keep existing BioWatch technology working? 

Finally, I understand that the Department is contemplating changes to the Bioterrorism Risk Assessment (BTRA). I am interested in understanding more about 

the changes to the BTRA, and how the Department will make sure that whatever 

biodetection technology is deployed addresses the threat posed. 

Mrs. BROOKS. We are very pleased to have a very distinguished 

panel before us today and want to thank you all for your time in 

preparing your written testimony and for your time before us today 

on this very important topic. 

To our left, on the panel, is Dr. Kathryn Brinsfield, serving as 

the acting assistant secretary of health affairs and chief medical officer for the Department of Homeland Security’s Office of Health 

Affairs. 

She began her service with DHS in July 2008, and previously 

served as associate chief medical officer and director of the division 

of workforce health and medical support within OHA. 

Prior to serving as acting assistant secretary and chief medical 

officer, she served on a detail to the National security staff as the 

director of medical preparedness policy. 

Before joining DHS, Dr. Brinsfield worked for various organizations, including Boston’s Emergency Services, Boston Metropolitan 

Medical Response System, and the DelValle Emergency Preparedness Training Institute. 

She graduated with honors from Brown University and received 

her M.D. from Tufts School of Medicine and her master’s in public 

health from Boston University. She completed her residency in 

emergency medicine at Cook County Hospital in Chicago and her 

EMS fellowship at Boston EMS. 

Our next witness is Dr. Reginald Brothers. Dr. Brothers was confirmed by the U.S. Senate on April 7, 2014, for the position of 

under secretary for science and technology at the U.S. Department 

of Homeland Security. 

Prior to joining DHS, Dr. Brothers served in the U.S. Department of Defense’s office of the assistant secretary of defense for re-
6 

search and engineering as the deputy assistant secretary of defense 

for research. 

Dr. Brothers received a B.S. in electrical engineering from Tufts 

University, an M.S. in electrical engineering from Southern Methodist University, and a Ph.D. in electrical engineering and computer science from MIT. 

Next is Mr. Chris Cummiskey, who was appointed acting under 

secretary for management at DHS in February 2014. 

Prior to assuming this position, Mr. Cummiskey served as the 

deputy under secretary for management from May 2010 to September 2013 and earlier as the chief of staff for the Management 

Directorate from March 2009 until May 2010. 

Prior to joining DHS, Mr. Cummiskey served as the chief information officer for the State of Arizona. 

Mr. Chris Currie is an acting director in GAO’s homeland security and justice team where he leads the agency’s work on emergency management and National preparedness issues. 

Prior to this assignment, Mr. Currie was an acting director in 

GAO’s defense capabilities and management team where he led reviews of DOD programs. 

In the decade since DHS was created, Mr. Currie has led numerous audits and assessments of DHS programs including those related to transportation security, research, and development of new 

technologies and the Department’s efforts to test and evaluate 

large acquisition programs and technologies. 

Mr. Currie joined GAO in 2002 and has a master’s in public administration from Georgia State and a B.A. in history from the 

University of Georgia. 

Dr. Deena Disraelly—did I pronounce that correctly—is a research staff member at the Institute for Defense Analyses. She has 

more than 17 years’ experience conducting analysis in the chemical, biological, radiological, and nuclear realm and working in and 

training others to support emergency response. 

Her work has focused on the policy, technological, operational, 

and organizational aspects of preparedness, emergency response, 

and consequence management, particularly as related to CBRN. 

Most recently, she has been focused on working with all levels 

of government to develop and evaluate biological preparedness 

plans, technologies and activities, improving interagency collaborations, developing new CBRN medical modelling methodologies, and 

studying potential methods for improving emergency response and 

disaster management. 

Dr. Disraelly joined IDA after 8 years in the Navy as a surface 

worker officer and Naval nuclear engineering officer. Additionally 

she served as a researcher for 2 years at MIT’s Center for Transportation and Logistics. 

I must say, this is one of the most incredible panels that we have 

had to address the subject at hand and we are very, very pleased 

that you all could be with us today. 

Your full written statements will appear in the record, and I will 

now recognize Dr. Brinsfield for 5 minutes. 

As you know, the light is green, it will become yellow when you 

have 1 minute and if you—when the light becomes red, if you could 
7 

please come close to wrapping up, we would appreciate it so we can 

make sure we hear from everyone. 

As you also may know, other Members will be coming in and out 

before the panel due to other commitments with other hearings. 

So with that, Dr. Brinsfield for 5 minutes. 

STATEMENT OF KATHRYN BRINSFIELD, ACTING ASSISTANT 

SECRETARY, OFFICE OF HEALTH AFFAIRS, U.S. DEPARTMENT OF HOMELAND SECURITY 

Dr. BRINSFIELD. Thank you, ma’am. 

Chairman Brooks, Ranking Member Payne, and distinguished 

Members of the subcommittee, thank you for inviting me to speak 

today. I appreciate the opportunity to testify on biological defense 

and specifically the BioWatch Program. 

I am honored to testify alongside my colleagues, Dr. Brothers 

and Mr. Cummiskey, as well as our colleagues from the GAO and 

IDA. 

As this is my first appearance before this subcommittee, please 

allow me to provide an overview of the Office of Health Affairs and 

the responsibilities of the chief medical officer of the Department 

of Homeland Security. 

OHA provides health and medical expertise in support of the 

DHA mission to prepare for, respond to, and recover from all 

threats. Our mission is to advise, promote, integrate, and enable a 

safe and secure workforce and Nation in pursuit of National health 

security. 

The chief medical officer is the principle medical adviser to the 

Secretary and to DHA components for all health security matters, 

including those having a CBRN nexus, and has a statutory responsibility to lead coordination of the Department’s biodefense activities. 

To that end, OHA conducts policy, planning, and operations related to preparing for and ensuring rapid response to biological 

events whether naturally-occurring, such as a pandemic, or manmade, such as an intentional release of aerosolized anthrax. 

Effective management of risks from biological threats and hazards depends on early warning and shared situational awareness. 

So critical decisions surrounding response and recovery are timely, 

well-informed, and ultimately save lives. 

The National Biosurveillance Integration Center, or NBIC, is 

housed with OHA and has the key responsibility to integrate, analyze, and share the Nation’s biosurveillance information to advance 

the safety, security, and resilience of the Nation. As a 24/7 operation, NBIC uses information technology tools that assist the collaborative process of integrating information and expertise bound 

to cross its biosurveillance partners at all levels of government. 

Just as surveillance is critical, detecting a biological attack early 

and identifying the biological agent is an essential part of our 

multi-layered approach to biodefense. The BioWatch Program was 

initially fielded in 2003 within 33 days of its announcement at 

President Bush’s State of the Union address and has been operational 24 hours a day, 365 days a year for more than 10 years. 

The program is a Nation-wide biosurveillance and detection system intended to partner with State and local public health and re-
8 

sponder communities to enhance our Nation’s ability to respond to 

a bioterrorism event. 

The sampling technology used by the BioWatch Program is designed to detect the intentional catastrophic release of select aerosolized biological agents and has a robust quality assurance element that includes laboratory and field audits to ensure accuracy. 

BioWatch has proven itself a key component of the Nation’s biodefense architecture. However this technology must be improved in 

response to the evolving threat in a cost-effective manner. 

In 2008, the BioWatch Program began examining new technologies to streamline operational timeliness, increase coverage 

and decrease costs. BioWatch began a technology acquisition 

known as Gen–3 to provide autonomous detection capability generating results as soon as 4 to 6 hours after the release of a biological 

agent rather than 12 to 36 hours needed by current operations. 

In 2012, the Government Accountability Office conducted a review of the acquisition and recommended that BioWatch perform 

an analysis of alternatives or AOA to ensure that BioWatch pursue 

an optimal solution. 

Using this recommendation, OHA requested that the Institute of 

Defense Analysis conduct an independent AOA to include a market 

survey of available biodetection technologies and a cost-benefit 

analysis. The purpose of the AOA in this process was not to issue 

a specific recommendation but to help inform DHS’s decision to 

proceed with any acquisition of biodetection technology. 

It was our assessment that the AOA suggested that an autonomous detection capability would be a valuable addition to current 

BioWatch operations in certain circumstances. However it did not 

find an overwhelming benefit to justify the cost of a full technology 

switch including one-to-one replacement and expanded coverage 

within and to new jurisdictions. 

Following a thorough review of the acquisition of record, the 

AOA and other studies on the future of biodetection capabilities, 

OHA, in consultation with our DHS colleagues, concluded that the 

autonomous detection system under consideration would not meet 

program objectives and recommend that the DHS leadership cancel 

its acquisition. This decision was formalized in an acquisition decision memo on April 29, 2014. 

Cancellation of the Gen–3 acquisition in no way lessens the importance of BioWatch current operations or the need to explore advancement in biodetection capabilities. OHA and S&T are now 

completing a plan to both test currently-available technology solutions and to look at indoor and outdoor applications. 

I want to emphasize that the Secretary, the Department, and our 

offices remain committed to the BioWatch program, its role in a 

layered-approach biodefense, and the advancement of its technological capabilities. 

Thank you, and I look forward to answering your questions. 

[The joint prepared statement of Dr. Brinsfield and Mr. Brothers 

follows:] 
9 

JOINT PREPARED STATEMENT OF KATHRYN BRINSFIELD AND REGINALD BROTHERS

JUNE 10, 2014 

Chairman Brooks, Ranking Member Payne, and distinguished Members of the 

subcommittee, thank you for inviting us to speak with you today. We appreciate the 

opportunity to testify on biological defense and specifically the Department of Homeland Security’s BioWatch program. We’re honored to testify alongside Acting Under 

Secretary Cummiskey as well as our colleagues from the Government Accountability 

Office (GAO) and the Institute for Defense Analysis (IDA). 

THE BIOTERROR THREAT

More than a decade after anthrax was mailed to Members of Congress and to 

media organizations, dozens of policy, intelligence, and technical reports have affirmed the viability of terrorist groups and violent extremists using biological weapons to cause death, suffering, and socio-economic disruption on a calamitous scale. 

In 2008, the Congressional Commission on the Prevention of Weapons of Mass Destruction Proliferation and Terrorism stressed the near-term and growing threat 

that terrorist use of biological weapons pose. The DHS Office of Health Affairs 

(OHA) and the Science and Technology Directorate (S&T) have worked diligently to 

increase understanding of the full spectrum of potential threats and their consequences as well as countermeasures and means of prevention. 

In 2001, the Defense Science Board affirmed that ‘‘there are no technical barriers 

to a large-scale bioattack.’’ We are living in the midst of a biotechnology revolution 

in which the knowledge and tools needed to acquire and disseminate a biological 

weapon are increasingly accessible. It is possible today to manipulate pathogens’ 

characteristics (e.g., virulence, antibiotic resistance) and even to synthesize viruses 

from scratch. These procedures will inexorably become simpler and more available 

across the globe as technology continues to mature. Thankfully, the combination of 

technical expertise required and the restrictions limiting the acquisition of the materials necessary for production still make this a challenging task. 

Even small-scale attacks, however, could be highly lethal and disruptive, and as 

has been noted, there is a real possibility of a campaign of bioattacks on multiple 

targets (the ‘‘reload’’ phenomenon)—because some of these weapons are self-replicating organisms. Moreover, it is not necessary for a nation-state to maintain a 

large stockpile of bioweapons as the development of a significant offensive bioattack 

capability could occur within weeks or months. 

Biological threats, including bioterrorism, pandemics, emerging infectious diseases, and animal and plant diseases, remain a top homeland security risk. A biological attack could impact any sector of our society and would place enormous burdens on our Nation’s public health, security, and critical infrastructures. The 2014 

Quadrennial Homeland Security Review includes a review of the biological threat 

landscape and the Department’s strategy to counter these threats. One aspect of our 

overarching strategy includes robust biosurveillance capabilities that provide situational awareness and early detection. These capabilities are important because in 

a biological event, every moment counts. The faster we detect an event, the faster 

we can take life-saving steps such as providing medical countermeasures and containing the threat. 

BIOSURVEILLANCE

It is challenging to recognize early indications of a biological attack because its 

release is invisible, and because of the global availability of pathogenic organisms, 

the dual-use nature of the required materials, and the small operational footprint 

necessary to produce the agents. Advance detection and disruption of a bio-weapons 

program will continue to be difficult and, as such, cannot be relied upon as the main 

focus of U.S. defenses against biological attacks. Instead, the United States has 

made a deliberate strategic choice to detect an attack through bio-agent release detection technology programs such as BioWatch and mitigate its affects by enhancing 

the capabilities of first responders and public health professionals to detect bioagents in the field and conduct reliable lab analyses. Other investments to improve 

our early detection capability include working to create sensors capable of automatically initiating protective actions (e.g., altering a building’s airflow patterns) and developing rapid diagnostic capabilities to guide our response. 

Effective management of biological threats and hazards depends on early warning 

and shared situational awareness, which in turn support response and recovery decision making that is timely, well-informed, and ultimately saves lives. The United 

States has numerous biosurveillance capabilities across human health, plant, ani-
10 

mal, food, water, and environmental domains distributed broadly across Federal, 

State, Tribal, territorial, and local government and the private sector. The National 

Biosurveillance Integration Center (NBIC), operated through the DHS Office of 

Health Affairs (OHA), is the designated Government entity charged with integration, analysis, and dissemination of the Nation’s biosurveillance information in order 

to advance National safety, security, and resilience. 

NBIC is a 24/7 operation that collaborates daily with the BioWatch program as 

well as other National Biosurveillance Integration System (NBIS) Federal department and agency partners and State, local, Tribal, and territorial entities. At this 

time, NBIC is monitoring and reporting on, among other biological events, avian influenza H7N9 in China; Middle East Respiratory Syndrome Coronavirus (MERSCoV) in a number of countries now including the United States; Chikungunya Fever 

in the Caribbean; Ebola Virus Disease in West Africa; and the highly pathogenic 

avian influenza H5N1 world-wide. 

BIOLOGICAL DETECTION AND THE BIOWATCH PROGRAM

Early detection of a biological attack and identification of the biological agent involved are critical to containing the spread of the agent as well as the successful 

treatment of affected populations. Early detection is part of a multi-layered approach to providing public health decision makers more time—and thereby more options—in responding to, mitigating, and recovering from a bioterrorist event or other 

threat to public health. If release of a bioagent is detected and assessed in a timely 

fashion, an appropriate prophylactic treatment can be started prior to the widespread onset of symptoms resulting in more lives saved. 

BioWatch is the only civilian-managed, Nation-wide surveillance and detection 

system for aerosol biological releases, and it is intended as an interface for State 

and local public health and responder communities to jointly respond to a bioterrorism event. The sampling technology used by the BioWatch program is designed 

to detect the intentional catastrophic release of the most threatening aerosolized biological agents. The BioWatch system consists of units that collect air samples in 

more than 30 cities and a network of local, State, and Federal laboratories that analyze samples on a daily basis with a goal of providing warning of possible biological 

attacks within 12 to 36 hours of an agent’s release. The BioWatch program has a 

robust quality assurance element that includes laboratory and field audits to ensure 

accuracy. BioWatch has conducted 37 laboratory and 20 field audits to date. For 

more than 10 years, BioWatch has operated 24 hours a day, 365 days a year. It is 

a proven asset to the Nation’s overarching biodefense architecture. 

The initial deployment of BioWatch in 2003 was intended to provide the most 

comprehensive detection network possible within budgetary, time, logistical, operational, and technical constraints. The complex coordination required to achieve the 

successful rollout of BioWatch across a broad range of Government and private entities was a difficult and hard-earned achievement. The BioWatch program was designed to be able to advance its technological capabilities to meet an evolving threat. 

Although technology can always be improved, the challenge is to do so cost-effectively and in pace with the evolving threat. 

AUTONOMOUS DETECTION ACQUISITION ACTIVITIES

As the National Strategy for Biosurveillance states, we must foster innovation and 

facilitate new biosurveillance activities—including new detection technologies. In 

2008, as directed by Congress, the BioWatch program began examining new technologies to shorten operational timelines, increase coverage, and decrease costs. Acknowledging the benefit of early warning of a biological attack and the prompt distribution of medical countermeasures, the program began exploring technologies 

that could reduce detection and response times in a cost-effective manner. 

For this reason, BioWatch began a technology acquisition process—known as Generation 3, or Gen–3—to provide autonomous detection capability that would eliminate the time-consuming steps of collecting filters by hand and transporting them 

to a laboratory for analysis. An autonomous detector is designed to be a ‘‘lab-in-abox’’ where the sampling and analysis processes will take place within the device, 

generating results as soon as 4 to 6 hours after the release of a biological agent, 

rather than the 12 to 36 hours needed by current operations. The BioWatch program began a phased acquisition for automated detection technology. Phase I was 

completed in June 2011 and assessed the maturity and technical capability of the 

biodetection technology market against a robust set of system requirements. These 

requirements included technical assay/characterization testing of two candidate systems and limited field testing of one vendor’s candidate autonomous detection system. 
11 

1The America Creating Opportunities to Meaningfully Promote Excellence in Technology, 

Education, and Science Reauthorization Act of 2010 (America COMPETES Reauthorization Act 

Pub. L. 111–358) outlines authorities for all Federal agencies to conduct prize competitions to 

engage broadly the American public to stimulate innovation that may potentially advance their 

agency mission. 2 Apex projects are cross-cutting, multi-disciplinary efforts requested by DHS components that 

are high-priority, high-value, and short turn-around in nature. They are intended to solve problems of strategic operational importance identified by a component leader. Apex Lite projects 

will be a middle ground between traditionally-managed projects and Apex efforts, building off 

lessons learned from previous Apex projects and scaling critical Apex elements to different time 

lines, scopes, and foci. 

In September 2012, the Government Accountability Office (GAO) recommended 

that BioWatch perform an Analysis of Alternatives (AoA) as well as re-evaluate its 

mission needs statement to ensure acquisition requirements were well-grounded and 

that the BioWatch program was pursuing an optimal and cost-effective solution. In 

an Acquisition Decision Memorandum issued September 7, 2012, the Acquisition Decision Authority (ADA) directed the BioWatch program to prepare a solicitation/request for proposal (RFP) for an AoA study, consistent with GAO’s recommendation. 

The AoA study, conducted by the Institute for Defense Analysis, was concluded 

on August 30, 2013, and the final report was released on December 20, 2013. Following an exhaustive market survey, the AoA report analyzed four different methodologies, not favoring one over another. The intent of the AoA was not to issue a 

recommendation but to help inform DHS’s decision to proceed with any acquisition 

of BioWatch technology. 

CANCELLATION OF GEN–3 ACQUISITION

The AoA determined that an autonomous detection capability would be a valuable 

addition to current BioWatch operations. However, it did not find an overwhelming 

benefit to justify the cost of a full technology switch (one-to-one replacement and expanded coverage within jurisdictions). Following a thorough review of the Gen–3 acquisition of record, the AoA and other studies on future biodetection technology, 

OHA, in consultation with S&T, the Management Directorate, and the Office of Policy, concluded that the autonomous detection system under consideration would not 

meet program objectives at a reasonable cost and recommended that DHS leadership cancel its acquisition. Secretary Johnson then directed Acting Under Secretary 

for Management Cummiskey to cancel the BioWatch Gen–3 technology acquisition. 

In accordance with this guidance, and per the Department’s Management Directive 

102 on acquisition procedures and processes, Acting Under Secretary Cummiskey 

convened the Acquisition Review Board for the BioWatch Gen–3 acquisition to formally cancel the acquisition of record on April 24, 2014. This cancellation reflects 

the need to implement cost-effective solutions, as it is critical that any upgrades to 

the technology be acquired and deployed in a staged manner and in parallel—not 

in place of—the current operational program. 

THE PATH FORWARD

Cancellation of the Gen–3 acquisition of record in no way reduces the capability 

of existing BioWatch operations or the need to investigate potential advancements 

in biodetection capabilities. OHA and S&T are working closely on the development 

of a systems approach to next-generation biodetection, including joint development 

of requirements moving forward. Evaluation of the existing operational BioWatch 

system is underway and will guide near- and long-term investments in new or updated capabilities. A full range of potential investments is under consideration from 

near-term incremental improvements to longer-term shifts such as a distributed, 

networked, sensor-agnostic biosurveillance architecture currently under development at S&T with potential for capability well beyond what the Department initially envisioned for Gen–3. 

Using newly-delegated prize authority,1 S&T and OHA have a platform for engaging and harvesting non-traditional Government performers through a biosurveillance grand challenge on this issue of National importance. S&T is also exploring 

a ‘‘Beyond BioWatch’’ Apex Lite 2 program that will, in partnership with OHA and 

other National biodefense stakeholders, work toward implementation of an integrated National systems approach to biodetection. We would be happy to share this 

vision and strategic approach to biosurveillance research with the subcommittee as 

it takes shape in the near future. 
12 

CONCLUSION

We want to emphasize that the Secretary, the Department, and our offices remain 

committed to the operational BioWatch Program, the role of vigilant biosurveillance 

as part of the layered approach to the Nation’s biodefense, and the advancement of 

innovative technological capability as part of an integrated systems approach to surveillance. In the coming years, we intend to focus our limited developmental resources on capacities to detect bioattacks in near-real time in order to enhance protective response actions. However, we will also have to consider future needs for detection of a wider range of potential threat agents, including genetically-altered, 

synthetic, or unanticipated agents, and possibly to enable detection of food and surface contamination. Faster, more detailed, and more reliable characterization of bioevents will be necessary to improve situational awareness and inform response. We 

must continue to develop an agile approach that accommodates possible epidemics 

of emerging disease or attacks using unforeseen bioagents or agents not addressed 

by stockpiled countermeasures. Strategies for coping with and stopping bioterror 

campaigns must be developed. Mechanisms of international cooperation in dealing 

with infectious disease outbreaks and collaborative approaches to financing and refining needed biodefense technologies and countermeasures must evolve. 

OHA and S&T are committed to working together with our colleagues across the 

interagency to address these challenges. We are deeply appreciative for this subcommittee’s continued support for our shared goals of health and homeland security. 

Mrs. BROOKS. Thank you. The Chairwoman will now recognize 

Dr. Brothers for 5 minutes. 

STATEMENT OF REGINALD BROTHERS, UNDER SECRETARY, 

SCIENCE AND TECHNOLOGY DIRECTORATE, U.S. DEPARTMENT OF HOMELAND SECURITY 

Mr. BROTHERS. Thank you, Chairman Brooks, Ranking Member 

Payne, and distinguished Members of the subcommittee. Thank 

you for the opportunity to join you today to discuss the Science and 

Technology Directorate, lessons learned from the BioWatch acquisition and the Department’s unified approach to biosurveillance moving forward. 

It is a privilege to appear before you today, along with my DHS 

colleagues from health affairs and the management directorate, as 

well as distinguished experts from the GAO and IDA. 

Today, science and technology were once drivers of threats and 

sources of solutions for those threats have also improved the lives 

of countless people. Take the internet, for one example. By connecting people and facilitating the flow of information, it is a central driver of the modern economy. It is also, among other things, 

a platform of choice for distributing IED recipes, has made communities around the world vulnerable to potentially devastating cyber 

attacks. 

With numerous potential industrial, environmental, and human 

impacts, biotechnology and the evolution of modern biosciences 

have a potential to be the next major disruptive force along the 

lines of the information technology revolution. 

Already, the availability of equipment and information has broken down barriers previously insurmountable to individuals outside 

State-funded biological programs. That means that the risk of 

groups or individuals creating and using a powerful bioweapon is 

real. 

Since becoming under secretary for science and technology, I 

have seen first-hand a passion at S&T for work on these types of 

tough problems. It really is a passion. Walking the halls of the di-
13 

rectorate, I hear how excited people are to get up in the morning 

and put their shoulder into tough homeland security problems. 

For addressing biological risks to homeland security, we work 

hand-in-hand with a broadly-based community of biodefense professionals and stakeholders, to develop technology that enables better 

preparation for and more effective response to biological attacks. 

At S&T, our National Biodefense Analysis and Countermeasures 

Center in Fort Detrick, Maryland is a fully integrated element of 

our Nation’s biodefense and National resource retribution and analysis during bioterrorism or biocrime events. Our chemical and biological defense division is dedicated to providing comprehensive biological threat characterization, as well as development of capabilities for pre-event assessment, discovery, and interdiction and for 

warning, notification, and analysis during incidents. 

As you know, the BioWatch program was once a part of the directorate. S&T has a long history of research and development support to the BioWatch program from before DHS’s Office of Health 

Affairs or OHA was created through the present time. 

In my time at S&T, I have seen a very functional, a very positive 

working relationship with OHA. We are unified in pursuit of the 

shared goal of development and implementation from an effective 

and efficient National biosurveillance framework. That is encouraging to me. Because now more than ever, S&T and OHA must be 

totally synchronized. The cancellation of BioWatch Gen–3 acquisition gives us at DHS an opportunity to jointly evaluate the current 

operational BioWatch program and to offer systems approach to 

next-generation biodetection. 

Numerous lessons learned by S&T, OHA and management directorate, are already guiding our unified path forward; for that reason, creating positive relationships between all three of our organizations. I am confident that we won’t repeat past mistakes. 

Moving forward, S&T and OHA will evaluate the full range of 

near- and long-term investments in new or updated capabilities. 

This includes potential for short-term, incremental improvements 

to the existing BioWatch system. This also includes longer-term 

shifts toward a distributed, networked, sensor-agnostic architecture 

with potential capability well beyond what the Department initially 

envisioned for the Gen–3 acquisition. 

At S&T, we are considering a potential BioWatch Apex program, 

Beyond BioWatch Apex program. Like other Apexes, this would be 

cross-cutting multidisciplinary effort and be focused on high-priority problems and would have a leadership buy-in in robust partnership between organizations. 

It would, in partnership with OHA and other National buyer defense stakeholders, work toward implementation of integrated National systems approach to biodetection. As part of this effort, we 

also look forward to using newly available tools like prize authority. These have potentials of platform for biosurveillance grand 

challenge that would allow S&T and OHA to access untapped energy, enthusiasm, expertise from the broader community of Government performance. 

As I am sure my colleagues will all agree, I believe all the ingredients necessary for a unified path forward for joining implementation of long-term vision for biosurveillance will make Americans 
14 

safe at a reasonable cost are in place at DHS. Working together, 

S&T and OHS, OHA’s energetic workforces have the expertise and 

experience necessary to successfully develop a technology that will 

be a pillar for our Nation’s next-generation biodefense. 

We certainly learned from lessons in the past, but we are focused 

right now on the opportunity before us to make a lasting impact 

on the Nation’s long-term biodefense and the opportunity to safeguard the country against current emerging biological threats. 

To close, I want to thank you again for the opportunity to join 

today’s discussion. The ingredients for success are in place, and we 

at DHS are unified in our path forward. 

I look forward to your questions. 

Mrs. BROOKS. Thank you. The Chairwoman now recognizes Mr. 

Cummiskey for 5 minutes. 

STATEMENT OF CHRIS CUMMISKEY, ACTING UNDER SECRETARY, MANAGEMENT DIRECTORATE, U.S. DEPARTMENT 

OF HOMELAND SECURITY 

Mr. CUMMISKEY. Thank you. 

Good morning, Chairman Brooks, Ranking Member Payne, Congressman Palazzo. Thank you for the opportunity to appear before 

you today to discuss lessons learned from the BioWatch program, 

as well as specifically discussing the acquisition of Generation–3. 

I also want to thank my fellow colleagues, the DHS, as well as the 

GAO, and the Institute for Defense Analysis for their dedicated 

work in this important area. 

As you understand the under secretary for management is also 

the chief acquisition officer for the Department. I oversee the policies and procedures used to acquire and oversee over $18 billion in 

goods and services each year. During my tenure, I have focused significant attention on improving the analysis and rigor for all 

phases of the acquisition life cycle. 

During the past 5 years, DHS has continued to focus on strengthening our acquisition oversight policies to ensure our major programs are steeped in established management principles. As indicated by GAO, we have made substantial progress in building an 

oversight process with clear and logical approval of gateposts 

backed by business intelligence that flags programs that are offtrack. 

I am pleased to report that in the past 3 years, no program has 

been authorized to proceed to the next Acquisition gatepost, unless 

they have followed the rigor prescribed in our governing policy, 

Management Directive 102, which was put into place in 2010. 

The BioWatch program has played an important role in the Department’s layered approach to mitigate new and evolving threats 

in providing Nation-wide biosurveillance capability. BioWatch Gen– 

2 has successfully monitored selected aerosolized biothreat agents 

in highly-populated areas. 

I want to reaffirm the Secretary’s commitment to Generation–2 

as the Department’s program of record for aerosol biological threat 

detection. In 2009, Congress authorized the Department to begin 

the development and testing of Generation–3 and noted that DHS 

must strike a careful balance between expediting the deployment 
15 

of new technologies and ensuring that such technologies be fully 

validated. 

The Department, now through MD–102 requires clear and cogent 

planning documents that are closely tracked throughout the acquisition life cycle. 

In September 2012, GAO concluded that the performance, schedule, and cost expectations presented in the early estimates were 

not developed with the rigor required in MD–102. As a result, significant adjustments were made to both schedule and cost estimates. 

GAO further recommended that BioWatch perform an analysis of 

alternatives or AOA, as well as reevaluate the mission needs statement to ensure acquisition requirements were well-grounded. 

In an acquisitions decision memorandum issued in September of 

that same month, then-Under Secretary for Management Rafael 

Borras, as the chief acquisition officer, paused further development 

of the BioWatch Gen–3 program pending the findings of the AOA. 

In December 2013, the AOA was published and found that while 

an autonomous detection capability would be a valuable addition to 

current BioWatch operations, there was not an overwhelming benefit to justify the cost of a full technological replacement estimated 

at $5.7 billion. 

Following a thorough review of the Generation–3 acquisition of 

record, the AOA and other studies of future biotechnology detection, Department officials concluded that the autonomous detection 

system under consideration would not meet the program’s objectives. 

Based on this information, Secretary Johnson tasked me to take 

the appropriate actions to cancel all acquisition-related activities 

associated with BioWatch Gen–3. 

On April 24, I convened an acquisition review board and directed 

that the Science and Technology Directorate work in concert with 

the Office of Health Affairs BioWatch program office to explore the 

development of an effective and affordable automated aerosol biodetection capability going forward. 

In conclusion, DHS has worked diligently to improve its acquisition processes and these efforts have produced more effective governance to current and future acquisitions. 

BioWatch is an example of the relevant application of the Department’s improved acquisition oversight process. 

As the Department’s chief acquisition officer, I can assure you 

this morning that I will continue to evaluate the risks of this program and will only provide authorization to proceed when well-established criteria are met. 

Thank you, Madam Chairwoman. 

[The prepared statement of Mr. Cummiskey follows:] 

PREPARED STATEMENT OF CHRIS CUMMISKEY

JUNE 10, 2014 

Chairwoman Brooks, Ranking Member Payne, and other distinguished Members 

of the subcommittee, I thank you for the opportunity to appear before you today to 

discuss lessons learned from the BioWatch program, specifically with regard to acquisition of Generation–3. 

I wish to express appreciation to my colleagues from the Government Accountability Office (GAO) for their long-standing and dedicated work to support the trans-
16 

formation of management at DHS. Over the past 4 years, we have forged an excellent working relationship and reached common ground on many issues. I am gratified by their recent comments that recognized the substantial progress the Department has made to address its high-risk areas. We are committed to sustaining that 

progress given the concrete changes we’ve made to solidify our acquisition management infrastructure, which includes policies, delegations, business intelligence, and 

governance. 

As Chief Acquisition Officer, I oversee the policies, processes, and procedures used 

to acquire and oversee over $18 billion in goods and services each year. During my 

tenure, I have focused significant attention on improving the analysis and rigor for 

all phases of the acquisition life cycle, from the requirements-development phase 

through implementation. This includes applying a more disciplined approach and 

greater vigor in the detailed analysis required before authorizing programs to proceed to the next phase of the life cycle. 

When I arrived at DHS nearly 5 years ago, the Management Directorate was in 

the process of strengthening acquisition policies and procedures. Former Under Secretary Rafael Borras and I directed our program management oversight function to 

ensure that any new procedures adhered to established management principles, and 

balanced risk mitigation with the need for rapid deployment. Our goal was to build 

an oversight process with clear and logical approval ‘‘gate posts’’ and business intelligence that could ‘‘flag’’ programs that were off-track. Finally, we wanted risk to 

be a significant factor considered during all acquisition decision events especially at 

the planning phase when strategies are developed. While the preference is to seek 

‘‘existing’’ technologies, I understand that the Department’s mission may sometimes 

require development of higher-risk, emerging technology. 

I am pleased to report that in the past 3 years, no program has been authorized 

by the Acquisition Review Board (ARB) to proceed to the next acquisition phase unless it has completed the required reviews and documentation. 

BACKGROUND

In 2011, Under Secretary Borras and I created the Office of Program Accountability and Risk Management (PARM) to serve as the Department’s central oversight body for major acquisition programs. A few of PARM’s principal oversight responsibilities is to standardize policy, conduct independent assessments of major 

programs at each stage of the life cycle, and ensure those programs have sufficient 

documentation before requesting authorization from the ARB to proceed to the next 

phase. 

To further drive common processes and procedures, Management Directive (MD) 

102–01 was issued to serve as the Department-wide policy for acquisition programs 

and is recognized by all component executives as the road map to document and 

manage their programs. In recent years, the ARB has increased its oversight reach 

and has taken action to cancel or pause several poor-performing/higher-risk programs that were not achieving the pre-established cost, schedule, and performance 

goals. When a program is paused, the DHS chief acquisition officer conducts an assessment and if the program should continue forward with development, the lead 

program manager develops the appropriate acquisition strategy and path forward. 

The program will remain in paused status until the chief acquisition officer approves the acquisition strategy and path forward. 

In accordance with this directive, acquisition decisions are made throughout a 

program’s life cycle based on valid cost estimates and planning documents, such as 

Mission Needs Statements and Operational Requirements Documents. In the past 

4 years, the Department has made great strides to improve the governance and 

oversight of acquisition programs. The oversight framework has been further 

strengthened through the establishment of a Component Acquisition Executive 

structure that serves as the single point of accountability for programs within the 

components. I rely heavily on the CAEs to support PARM by providing day-to-day 

oversight of major programs within their components. 

Since 2009, not only have we have forged a comprehensive integration strategy, 

we have also demonstrated substantial progress, which led GAO to acknowledge in 

their 2013 High-Risk report that, ‘‘Significant progress has been made to transform 

and integrate the Department into a more cohesive unit.’’ In fact, they stated in December 2012 that, ‘‘the Department has made substantial progress in many areas 

and if their Integrated Strategy is fully implemented, they are on a path to be removed from the High-Risk List.’’ Any progress we have made is the direct result 

of an across-the-board commitment by operational components and support components to follow a clear and logical strategy. This progress has been reinforced by 
17 

the willingness of our components and line-of-business chiefs to leverage best practices in both the procurement and program management disciplines. 

In April of this year, Secretary Johnson issued a memorandum directing the Department to further unify its efforts in the way we plan, program, budget, and execute our investments. One of the principal focus areas of the Unity of Effort initiative is the continued refinement of our acquisition oversight framework, especially 

in the earliest stages where acquisition requirements are developed. 

BIOWATCH PROGRAM

The BioWatch program plays an important role in the Department’s layered approach to mitigate new and evolving threats by providing Nation-wide biosurveillance capability. BioWatch Generation–2 (Gen–2) is successfully monitoring for select aerosolized biothreat agents in highly-populated areas. I want to reaffirm the 

Secretary’s commitment to Gen–2 as the Department’s program of record for aerosolized biological agent threat detection. 

In 2009, Congress authorized the Department to begin the acquisition of a next 

generation (Generation–3, or Gen–3) BioWatch system that would be able to respond autonomously to the aerosol release of certain biothreat agents, providing significantly earlier detection than Gen–2 and enabling quicker deployment of life-saving medical countermeasures. Congress noted that DHS must ‘‘strike a careful balance between expediting the deployment of new technologies and ensuring that such 

technologies have been fully validated.’’ Congress appropriated $34.5 million for 

field testing of systems beyond Gen–2 and requested that any resulting contracts 

be awarded competitively. It is important to note that acquisitions of new or emerging technology pose a higher risk than traditional acquisitions given the need to 

field cost-effective solutions at a pace that matches the evolving threat. As such, the 

Department requires clear and cogent planning documents that are closely tracked 

and followed throughout the development life cycle. 

In September 2012, GAO concluded that the performance, schedule, and cost expectations for the Gen–3 acquisition, which predated the issuance of MD–102, were 

not developed with the rigor required in that document. As a result, significant adjustments were made over time to both schedule and cost estimates. GAO further 

recommended that BioWatch perform an Analysis of Alternatives (AoA), as well as 

re-evaluate its mission needs statement to ensure acquisition requirements were 

well-grounded and that BioWatch pursued an optimal solution. In an Acquisition 

Decision Memorandum issued September 7, 2012, the Under Secretary for Management, as the Acquisition Decision Authority, directed the BioWatch program to develop requirements and conduct an AoA. 

In December 2013, the AoA was published and found that an autonomous detection capability would be a valuable addition to current BioWatch operations. However, it did not find an overwhelming benefit to justify the cost of a full technology 

replacement. Following a thorough review of the Gen–3 acquisition of record, the 

AoA, and other studies on the future biodetection technology, the Office of Health 

Affairs, in consultation with the Science & Technology Directorate, Office of Policy, 

and Management Directorate, concluded that the autonomous detection system 

under consideration would not meet program objectives and recommended that DHS 

leadership cancel its acquisition. 

Based on this information, Secretary Johnson directed me to cancel all acquisition-related activities associated with BioWatch Gen–3. On April 24, 2014, I convened an ARB and requested that the Science & Technology Directorate work with 

the BioWatch program office to improve our biodetection capability by exploring the 

development and maturation of an effective and affordable automated aerosol biodetection system. 

CONCLUSION

DHS has worked diligently to improve its acquisition processes and these efforts 

have produced more effective governance and significant improvements to future 

and current acquisitions. The BioWatch Gen–3 program is an example of the successful application of the Department’s improved acquisition oversight process because it ultimately led to the correct decision that the level of maturity of the technology was not sufficient at this date to justify proceeding. As the Department’s 

Chief Acquisition Officer, I will continue to evaluate the risk of this and other programs, and will only provide authorization to proceed when pre-established criteria 

are met. 

While there is still much work to do, the Department has made significant strides 

in improving acquisition and investment management for the Department’s portfolio 

of major programs. I believe we are making progress in shifting the paradigm so 
18 

investment decisions are more empirically driven and there is qualified technical expertise to support program managers at each phase of the life cycle. 

Mrs. BROOKS. Thank you, Mr. Cummiskey. 

The Chairman now recognizes Mr. Currie for 5 minutes. Thank 

you. 

STATEMENT OF CHRIS CURRIE, ACTING DIRECTOR, HOMELAND SECURITY AND JUSTICE ISSUES, U.S. GOVERNMENT 

ACCOUNTABILITY OFFICE 

Mr. CURRIE. Thank you, Chairman Brooks and Ranking Member 

Payne, other Members of the subcommittee. I appreciate the opportunity to be here today. 

Today I would like to focus on the past, present, and the future 

of the BioWatch program. There are three areas I would like to discuss. 

First are lessons learned from the Generation–3 acquisition. Second, are concerns our work has raised about DHS research and development efforts. Third are observations we have and questions 

that should be answered as the BioWatch program moves ahead. 

Regarding the Gen–3 acquisition, lessons can definitely be 

learned. We reported that DHS pursued the Gen–3 technology 

without always following its acquisition policies. For example, we 

previously recommended that DHS conduct a robust analysis of 

program alternatives, the AOA, and cost estimate for Gen–3. 

Prior program decisions were made without this information. 

DHS listened. The more robust AOA they completed last year 

and updated cost estimate provided better information to make a 

cost-benefit decision about the program. DHS ultimately decided to 

cancel Gen–3 based on that information. 

While opinions will differ on whether Gen–3 was a failure or not, 

what is clear is that DHS made the decision to cancel by following 

its acquisition processes. 

This is encouraging progress because as this committee knows, 

and as you mentioned in your opening statement, Madam Chairwoman, failure to follow its acquisition policies is a major reason 

that DHS management is still on GAO’s high-risk list. 

My second point today pertains more specifically to the Science 

and Technology Directorate. Our body of work on DHS research 

and development, or R&D, raises management concerns that could 

impact S&T’s efforts to develop future biodetection technologies. 

More specifically, we reported in 2012 that DHS had no policies 

at the time for defining, overseeing, or coordinating R&D across the 

whole Department. As a result, R&D efforts were fragmented and 

overlapping, which could lead to unnecessary duplication. 

Further, while S&T had agreements in place to transfer technologies to other DHS components, none of these at the time had 

resulted in a technology actually being transitioned to implementation. Also, some DHS component officials did not view coordination 

with S&T positively. 

We made a number of recommendations to address these issues. 

DHS agreed, and they are making progress in addressing them. 

However, efforts are early and it is too soon to tell what impact 

these efforts are going to have. 
19 

The third area I would like to discuss are observations to consider as the BioWatch program moves ahead. For years, the focus 

has been on developing the Gen–3 system. Now that there is no 

Gen–3 to replace it, there are new questions about the performance 

and maintainability of the current system that need to be answered. 

For example, DHS officials told us that some Gen–2 equipment 

is nearing the end of its useful life and will need to be replaced as 

early as next year. But it is not yet clear how the current system 

will be replaced or upgraded. 

Also while Gen–2 has been used in the field for more than a decade now, information about its technical capabilities, including the 

limits of detection, is actually pretty limited. 

For example, in 2011 the National Academy of Sciences reported 

that rapid initial deployment of BioWatch did not allow for sufficient testing and evaluation. 

I would like to close with one last broader point today. This February, as you noted, your committee held a hearing on the overall 

bioterror threat. With the Gen–3 cancellation and Gen–2 system 

nearing the end of its life, DHS and its partners have an opportunity right now to assess the overall strategy for biosurveillance 

and how technology fits into it. 

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

Biosurveillance. However, it didn’t include a way to identify investment priorities among various biosurveillance efforts, such as how 

much do we invest in detection technologies? 

These details were to be part of an implementation plan to follow, as you noted, the National strategy, but it has not been issued 

yet. We think these details will be very important to inform DHS 

decisions moving ahead. 

This completes my prepared remarks. I would be pleased to answer any questions you have. 

[The prepared statement of Mr. Currie follows:] 

PREPARED STATEMENT OF CHRIS CURRIE

JUNE 10, 2014 

GAO HIGHLIGHTS

Highlights of GAO–14–267T, a testimony before the Subcommittee on Emergency 

Preparedness, Response, and Communications, Committee on Homeland Security, 

House of Representatives. 

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 canceled 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 
20 

1Traditional 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 allDHS 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. 

BIOSURVEILLANCE.—OBSERVATIONS ON THE CANCELLATION OF BIOWATCH GEN–3 AND

FUTURE CONSIDERATIONS FOR THE PROGRAM

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 on-going. 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. 

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
21 

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. 2GAO, Biosurveillance: Efforts to Develop a National Biosurveillance Capability Need a National Strategy and a Designated Leader, GAO–10–645 (Washington, DC: June 30, 2010). GAO, 

Department of Homeland Security: Oversight and Coordination of Research and Development 

Should Be Strengthened, GAO–12–837 (Washington, DC: Sept. 12, 2012). GAO, Biosurveillance: 

Observations on BioWatch Generation–3 and Other Federal Efforts. GAO–12–994T (Washington, 

DC, 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, DC: 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, DC: April 26, 2013). GAO, Department of Homeland Security: Oversight and Coordination of Research and Development Efforts Could Be Strengthened, 

GAO–13–766T (Washington, DC, July 17, 2013). GAO, Canceled DOD Programs: DOD Needs to 

Better Use Available Guidance and Manage Reusable Assets, GAO–14–77 (Washington, DC: 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, 

DC, April 2014). 3GAO–13–766T. 

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. 

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., lab-ina-box). The new technology would have reduced detection time, potentially generating a result in under 6 hours, and eliminated certain labor costs. 

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 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 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. 

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. 
22 

4GAO, High-Risk Series: An Update, GAO–05–207 (Washington, DC: January 2005). 5For examples, see GAO, Homeland Security: DHS Requires More Disciplined Investment 

Management to Help Meet Mission Needs, GAO–12–833 (Washington, DC: Sept. 18, 2012); Department of Homeland Security: Assessments of Selected Complex Acquisitions, GAO–10–588SP 

(Washington, DC: June 30, 2010); and Department of Homeland Security: Billions Invested in 

Major Programs Lack Appropriate Oversight, GAO–09–29 (Washington, DC: Nov. 18, 2008). 6GAO, Department of Homeland Security: Progress Made; Significant Work Remains in Addressing High-Risk Areas, GAO–14–532T (Washington, DC: 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. 7GAO–12–810. 

8The 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. 

BACKGROUND

DHS Acquisitions and the Cancellation of Gen–3 

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 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 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. 

BioWatch in Action 

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 Ac-
23 

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. 13 According to DHS officials, the Gen–3 acquisition was on-going 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 life-cycle 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. 

tionable 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

OUR PRIOR WORK ON THE GEN–3 ACQUISITION IDENTIFIED CHALLENGES AND DHS HAS

SINCE CANCELED THE PROGRAM

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 

Life-cycle Framework, which is designed to help ensure that the mission need driving the acquisition warrants investment of limited resources.13 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. 

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 
24 

14 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. 15 According 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. 

capability gap identified in the Mission Needs Statement. The DHS Acquisition Lifecycle 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 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 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. 

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. 

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 

cost-benefit and risk information. DHS concurred with the recommendation and in 

2012, DHS directed the BioWatch program to complete an updated AoA.15

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 
25 

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, DC: Mar. 

2, 2009). 18GAO–12–837. 19GAO–12–810. 

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. 

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 R&D EFFORTS ALSO FACE CHALLENGES THAT COULD IMPACT THE BIOWATCH

PROGRAM

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 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 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. 

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.19 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 
26 

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. 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. 

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. 

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 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 on-going and have not yet been completed.20

FUTURE CONSIDERATIONS FOR THE CURRENTLY-DEPLOYED GEN–2 SYSTEM

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. 

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 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. 

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 
27 

23GAO–10–645. 

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 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 on-going 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. 

Mrs. BROOKS. Thank you, Mr. Currie. 

The Chairwoman now recognizes Dr. Disraelly for 5 minutes. 

STATEMENT OF DEENA S. DISRAELLY, RESEARCH STAFF, 

STRATEGY, FORCES, AND RESOURCES DIVISION, INSTITUTE 

FOR DEFENSE ANALYSES 

Ms. DISRAELLY. Thank you, Chairman Brooks, Ranking Member 

Payne, and distinguished Members of the subcommittee for inviting 

me to speak with you today. My name is Dr. Deena Disraelly and 

I am a research staff member at the Institute for Defense Analyses 

and the team leader on the BioWatch Analysis of Alternatives. I 

am honored to be here today to discuss our work with you. 

The Institute for Defense Analyses is a Federally-funded research and development center assisting the Department of Defense and other Federal agencies in addressing important National 

security issues, particularly those requiring scientific and technical 

expertise. 

We were tasked by the BioWatch program office within the Department of Homeland Security to conduct an Analysis of Alternatives subsequent to the Government Accountability Office report 

on biosurveillance and the BioWatch Gen–3 acquisition. 

Our study is documented in the BioWatch Analysis of Alternatives, which is summarized very briefly in the written testimony 

we submitted. 

Based on the Department’s guidance, an Analysis of Alternatives 

provides the systematic, analytic, and decision-making process to 

facilitate identification of an optimal solution for an identified capability gap. 

In this case, the capability gap was established in Homeland Security Presidential Directive–10, which called for early warning, 

detection, or recognition of biological weapons attacks to permit a 

timely response to mitigate their consequences. 
28 

The intent of the Analysis of Alternatives was to identify material and non-material biological surveillance capabilities, with the 

potential to reduce casualties resulting from the release of an aerosolized pathogen, and to conduct our study in accordance with the 

Department’s guidance documents on established metrics and 

methodologies. 

It was not within the scope of our study to provide a recommendation about the disposition of the BioWatch Gen–3 system. 

Following a review of approximately 500 biological surveillance 

capabilities, we identified four candidate alternatives, each with an 

anticipated operational capability to perform the BioWatch mission 

and concepts of operation to detect an aerosolized biological event. 

Autonomous identification systems are labs in a box that collect 

and test environmental samples on site. Environmental collection 

systems collect environmental samples that are then picked up and 

transported to an off-site laboratory for analysis. 

The Sentinel population alternative involves police officers carrying lightweight portable collectors for subsequent laboratory sample analysis. 

Clinical diagnosis and diagnostics are a combination of technologies and activities used to identify disease in symptomatic individuals and notify the appropriate public health authorities. 

The Analysis of Alternatives provides the Government decisionmakers a framework for thinking about the trade-offs among the 

alternatives examined. Our findings can be summarized as follows. 

Clinical diagnosis and diagnostics is the least expensive alternative, and was assumed to have a probability of detection of 100 

percent because every disease is eventually diagnosed. However, diagnosis takes time and detection of an event requires some number 

of diagnosed cases. Therefore this alternative also had the highest 

number of casualties. 

The Sentinel population alternative had a high probability of detection, and those detections happened relatively quickly, resulting 

in lower numbers of casualties. That probability of detection is 

achieved with a large number of roving detectors, meaning a large 

number of samples processed several times a day. 

The result is a life-cycle cost estimate four times that of environmental collection and autonomous identification. 

Environmental collection is currently deployed, as has been 

noted, and is less expensive than autonomous identification. However, it also takes longer to identify agents, which may lead to an 

increase in casualties for detected attacks. 

Autonomous identification has a slightly higher life-cycle cost estimate than environmental collection. Additionally, while it 

achieves the fastest detections, when it detects, it only detects on 

average approximately half the number of attacks detected by environmental collection, resulting in increased numbers of casualties 

due to large numbers of missed attacks. 

HSPD–10 is still in effect and, as such, the imperative remains 

for an early warning and detection system to identify biological 

events and trigger a response to mitigate their consequences. Our 

Analysis of Alternatives provided objective, analytical information 

to support DHS’s decision-making with regard to that directive. 

This concludes my opening remarks. Thank you. 
29 

1 U.S. Department of Homeland Security (DHS), Acquisition Management Instruction/Guidebook, DHS Instruction Manual 102–01–001, Appendix G (Washington, DC: DHS, 2011), G–3. 2President George W. Bush, Biodefense for the 21st Century (hereafter: HSPD–10), Homeland 

Security Presidential Directive HSPD–10 (Washington, DC: The White House, 2004). 3Deena Disraelly et al., BioWatch Analysis of Alternatives, Institute for Defense Analyses 

(IDA), Paper P–5083 (Alexandria, VA: IDA, 2013). 4DHS, Office of Health Affairs (DHS/OHA), Gen–3 [Generation–3] Autonomous Detection System, Operational Requirements Document (ORD) v 2.2 (hereafter: Gen–3 ORD) (Washington, DC: 

DHS, 2012), ES–1, For Official Use Only (FOUO). 5DHS/OHA, Gen–3 ORD, FOUO; Bush, HSPD–10. 6 U.S. Government Accountability Office (GAO), BioSurveillance: DHS Should Reevaluate Mission Need and Alternatives before Proceeding with BioWatch Generation–3 Acquisition (hereafter: 

BioSurveillance—Reevaluate Mission Need), GAO–12–810 (Washington, DC: GAO, 2012), 9. 

[The prepared statement of Ms. Disraelly follows:] 

PREPARED STATEMENT OF DEENA S. DISRAELLY

JUNE 2014 

A. INTRODUCTION

Good morning Chairman Brooks, Ranking Member Payne, and distinguished 

Members of the House Subcommittee on Emergency Preparedness, Response, and 

Communication. My name is Dr. Deena Disraelly. I am a research staff member at 

the Institute for Defense Analyses (IDA) and the project lead for the BioWatch Analysis of Alternatives (AoA). I am honored to appear before you today to discuss this 

study and its results. 

In October 2012, the BioWatch Program Office asked IDA, a Federally-Funded 

Research and Development Center (FFRDC) assisting the Department of Defense 

and other Federal agencies in addressing issues of National security, to conduct an 

AoA of capabilities to meet the biosurveillance mission. According to U.S. Department of Homeland Security (DHS) guidance, an AoA provides ‘‘a systematic analytic 

and decision-making process to identify and document an optimal solution for an 

identified mission capability gap.’’1 The BioWatch AoA addresses a capability gap 

identified in Homeland Security Presidential Directive (HSPD)–10 Biodefense for the 

21st Century, namely the requirement for an ‘‘early warning, detection, or recognition of biological weapons attacks to permit a timely response to mitigate their consequences.’’2 This AoA identified material (technology) and non-material (activity) 

biological surveillance capabilities—comprised of one or more technologies or related 

activities—with the potential to reduce mortality and morbidity from an aerosolized 

release of a pathogen. Specifically, the AoA focused on four candidate alternatives 

that will be defined later in this presentation. 

While the objective of this study was to identify and compare capabilities, IDA 

was not asked to provide DHS with any recommendations about the disposition of 

the BioWatch Generation–3 (Gen–3) system. 

The IDA team’s BioWatch Analysis of Alternatives 3 was delivered to the BioWatch 

Program Office in December 2013. What follows is a brief discussion of the AoA objectives, methodology, and findings extracted from the more detailed discussion in 

that paper. 

B. ANALYSIS OF ALTERNATIVES (AOA) BACKGROUND AND OBJECTIVES

In accordance with HSPD–10, the DHS BioWatch Program is intended to provide 

‘‘a Nation-wide biosurveillance capability to monitor for select aerosolized biothreat 

agents in highly populated areas... and is a partnership between Federal, State, 

and local governments for the purpose of ensuring the protection of the Nation’s 

population against biological threats.’’4 The objective of the BioWatch collectors is 

to monitor the air continuously for agents of concern and provide regular analyses 

of the results. The goal is to field a system that is operational 24 hours per day, 

365 days per year and able to signal an attack early enough to promote quick response.5

The BioWatch Program was created in 2003 ‘‘to provide early warning, detection, 

or recognition of biological attack.’’6 The first environmental collectors (Generation– 

1) were deployed in March of 2003, with deployment eventually reaching 20 major 

metropolitan areas. The program began a second deployment (Generation–2) immediately in the wake of the previous deployment, adding ten jurisdictions and ‘‘indoor 

monitoring capabilities in three high-threat jurisdictions and provided additional capacity for events of national significance, such as major sporting events and political 
30 

7 Ibid. 

8DHS published an interim Acquisition Directive 102–01 in November 2008; this document 

includes the requirement for a capability development plan ‘‘including the initial ground rules 

for the Analysis of Alternatives (AoA) or Alternatives Analysis (AA) . . . to begin the Analyze/ 

Select phase’’ once the Mission Needs Statement (MNS) is approved. DHS, Acquisition Directive 

102–01, version 1.9, Interim (Washington, DC: DHS, 2008), 14. 9DHS, Acquisition Management Directive 102–01 (hereafter: AMD 102–01) (Washington, DC: 

DHS, 2010), 6; this document has since been supplemented and collated into DHS, Acquisition 

Management Directive 102–01, Revision 2 (hereafter: AMD 102–01 Rev. 2) (Washington, DC: 

DHS, 2013). 10DHS, Mission Needs Statement for BioWatch Gen–3 Autonomous Detection System (hereafter: Mission Needs Statement v.2.0), Version 2.0, DRAFT (Washington, DC: DHS, 2012), 

FOUO. 11 ‘‘Department of Homeland Security Research & Development Partnerships Group: Product 

Realization Guide,’’ DHS, accessed January 7, 2013, https://www.dhs.gov/sites/default/files/ 

publications/product-realization-guide-partnership-focus-508-1.pdf. Technology readiness level 6 

indicates that the capability of a representative model or prototype system has been tested in 

a relevant environment, including a laboratory or simulated operational environment. Taken 

from: Homeland Security Institute, Department of Homeland Security Science and Technology 

Readiness Level Calculator, Version 1.1 (Washington, DC: Homeland Security Institute, 2009), 

B–23. 12This is based on the stated assumption that a BioWatch Gen–3 detector will be available 

and fielded within 2 to 5 years. 13DHS, BioWatch Gen–3 Systems Engineering Life Cycle Tailoring (SELCT) Plan for the 

BioWatch Generation–3 Program, Version 1.1 (Washington, DC: DHS/OHA, 2012), A–1, FOUO; 

and DHS/OHA, Gen–3 ORD, 3–1, FOUO. 14 In the final evaluation of alternatives, budget should be a constraint and is, therefore, listed 

here. Budget, however, is not used as a hard boundary in this AoA because the exact BioWatch 

budget is not known. GAO, BioSurveillance—Reevaluate Mission Need, 26, 30–31; and, DHS, 

‘‘BioWatch Gen–3 Phase II Industry Day,’’ briefing, Washington, DC, September 12, 2011. 

conventions.’’7 Generation–1 and Generation–2 collectors are predominantly located 

in outdoor environments and the overall system, as currently implemented, relies 

on both the collectors and teams of field and laboratory personnel. The 2009 DHS 

Appropriations Act established the appropriations for an improved biodetection capability. 

In 2010, DHS published its first Acquisition Directive (DHS Directive 102–01),8

which requires DHS components pursuing acquisition programs to perform an AoA 

or Alternatives Analysis 9 during procurement. Two years later, the Homeland Security Studies and Analysis Institute published the BioWatch Gen–3 Program Acquisition Assessment. Soon after, the U.S. Government Accountability Office (GAO) published GAO–12–810, BioSurveillance: DHS Should Reevaluate Mission Need and Alternatives Before Proceeding with BioWatch Gen–3 Acquisition. Both reports recommended that the BioWatch Program Office perform an AoA for the BioWatch Program. Subsequently, the BioWatch Program Office asked IDA to conduct an AoA of 

biosurveillance capabilities in accordance with applicable DHS guidance. 

C. AOA PROJECT METHODOLOGY

1. Methodology Overview 

The first step in the AoA process was to consult relevant studies and literature 

on biosurveillance and conduct a market survey of all biosurveillance capabilities 

and their component technologies/activities (hereafter referred to simply as capabilities). During the course of the market survey, the IDA team identified approximately 500 biosurveillance capabilities that are either readily deployable or in development. Constraints were defined then used to identify selected candidate alternatives that could fulfill the BioWatch mission need and requirements.10 Specifically, the selected candidate alternatives met the following constraints: 

1. Include technologies and activities at, or equivalent to, technology readiness 

level (TRL) 6.11

2. Be available to deploy within 2 to 3 years and be fully fieldable within 2 to 

5 years of the completion of the AoA.12

3. Be able to detect an aerosolized biological attack for, at least, the same five 

threshold biological agents as required for Gen–3.13

4. Are anticipated to be fully fieldable and sustainable within the budget already allocated for BioWatch over the next 5 years (the budget figure is in fiscal 

year 2013 dollars and is not adjusted for inflation or other time-dependent increases).14

5. Fill a capability gap as defined in the BioWatch Gen–3 Mission Needs Statement and align with (or have) a viable concept of operations. 
31 

15Sally Phillips, ‘‘DHS Office of Health Affairs (OHA) Review of Candidates Selected for 

BioWatch Analysis of Alternatives (AoA),’’ memorandum to Deena Disraelly, May 24, 2013. 16Proposed as an autonomous detection platform, BioWatch Gen–3 would be an example of 

an autonomous identification capability. 17 Environmental Collection simulates the current BioWatch Generation–2 system. 18 Bush, HSPD–10, 6; DHS, Mission Needs Statement v.2.0, C–5, FOUO; and DHS/OHA, 

SELCT Plan, 3–4, FOUO. 19 In this instance, the term BioWatch Actionable Result (BAR) denotes the positive presence 

of a biological threat agent in an environmental or clinical sample; for the purposes of this 

study, the BioWatch actionable result triggers a response in the form of a stakeholder meeting/ 

teleconference to discern if a threat exists and determine what, if any, public health intervention 

is required. 20Defense Acquisition University, ‘‘Operational Availability,’’ in Glossary of Defense Acquisition Acronyms and Terms, 15th ed., December 2012, accessed July 30, 2013, https:// 

dap.dau.mil/glossary/Pages/2331.aspx. 21For each candidate alternative, casualties are calculated following a BioWatch actionable 

result, which triggers a public health intervention. 

Based on these criteria, the IDA team proposed four alternatives for additional 

analyses. Additional analyses included casualty modeling, life-cycle cost estimates, 

and evaluation of the Net Present Value and Return on Investment. 

2. Selected Alternative Biosurveillance Candidates 

The four selected candidate alternatives identified through the AoA process and 

approved as reasonable capability representatives by the DHS Acting Principal Deputy Assistant Secretary of Health Affairs 15 are (in alphabetical order): 

1. Autonomous Identification:16 Autonomous and integrated multi-component 

systems that perform all environmental sampling and on-site testing without 

human intervention or control. 

2. Clinical diagnosis/diagnostics with mandatory U.S. Centers for Disease Control and Prevention (CDC)/local public health disease reporting (hereafter Clinical Diagnosis/Diagnostics): Technologies and activities used in combination to 

evaluate and assess the disease manifesting in symptomatic individuals, combined with notification to the CDC regarding the detection of specific diseases 

in a timely manner. 

3. Environmental collection with manual sample retrieval with analytical laboratory (hereafter Environmental Collection17): Technologies that collect aerosol 

samples that are manually retrieved and transported to an analytical laboratory 

for analysis. 

4. Sentinel population with technological collectors with analytical laboratory 

(hereafter Sentinel Population): A limited portion of the population (e.g., law enforcement officers) wearing lightweight, portable, personal air samplers to collect samples for detection/identification of biological agents with subsequent laboratory analysis. 

3. Metrics, Scenarios, and Assumptions 

a. Mission Tasks, Measures of Effectiveness (MOE), and Measures of Performance (MOP) 

Upon the selection of the four alternatives, the next step in the AoA process was 

to formulate a hierarchy of metrics including mission tasks, measures of effectiveness, and measures of performance. 

Per HSPD–10 and the BioWatch documentation, a BioWatch system has four specific mission tasks:18

• Early warning: Detect an aerosolized biological agent attack 24 hours per day, 

365 days per year; 

• Reinforce existing systems: Utilize concept of operations, processes, and other 

biosurveillance activities that have been accepted by Federal, State, and local 

authorities to evaluate a BioWatch Actionable Result (BAR);19

• Timely response: Identify a BioWatch actionable result and initiate an appropriate public health intervention in a timely manner; and 

• Operate in Multiple Environments: Operate in outdoor, indoor, and mixed (indoor and outdoor) environments. 

Based on the mission tasks, three measures of effectiveness were identified: (1) 

Availability—degree that a system or group of systems are operationally capable of 

performing an assigned mission;20 (2) casualties—number of exposed and infected 

individuals who eventually manifest disease symptoms following a BioWatch actionable result and a subsequent trigger of a public health intervention,21 estimated as 

a function of the systems’ ability to respond within an allotted time and the speed 
32 

22Douglas N. Klaucke et al., ‘‘Guidelines for Evaluating Surveillance Systems,’’ Morbidity and 

Mortality Weekly Report (MMWR) 37, no. S–5 (1988): 1–18; and Ruth A. Jajosky and Samuel 

L. Groseclose, ‘‘Evaluation of Reporting Timeliness of Public Health Surveillance Systems for Infectious Diseases,’’ BioMed Central (BMC) Public Health 4, no. 29 (2004): 1–9. 23 Nerayo P. Teclemariam et al., BioWatch Technical Analysis of Biodetection Architecture Performance, Sandia Report, SAND2012–0125 (Livermore, CA: Sandia National Laboratories, 

2012), 16, FOUO. 24DHS, Acquisition Concept of Operations (CONOPS) for BioWatch Gen–3 (Hereafter: Acquisition CONOPS for Gen–3), version 0.1 (Washington, DC: DHS, 2012), FOUO. 25Due to the diversity of these agents with regard to contagion, lethality, and long-term care 

requirements, these three diseases were considered representative of the diseases resulting from 

aerosolized exposure to the five threshold biological agents required for Gen–3. 26 Net Present Value is the present value of calculated benefits and costs over a defined number of time periods—for the purpose of IDA’s study, 20 years. Return on Investment is the net 

benefit expressed as a percentage of the investment amount. Net Present Value and Return on 

Investment may also be negative depending on perceived risk of attack and value of human life 

for three of the four alternatives. Clinical Diagnosis/Diagnostics always has a positive Net 

Present Value and Return on Investment. 

or delay between steps in a biosurveillance system;22 and (3) probability of detection—effectiveness of the alternative at detecting aerosolized biological weapons attacks, measured using the probability of detection calculation as a proxy as described below.23

The IDA team then identified five measures of performance that were mapped to 

the measures of effectiveness (see Figure 1). These measures of performance included coverage, number of detectable and identifiable agents, operational environment, probability of detection, and time to detect/identify. 

b. Operational and Modeling Scenarios 

The four selected candidate alternatives were evaluated against three operational 

scenarios each with its own operational setting—outdoors (represented by metropolitan Chicago), indoors (represented by O’Hare International Airport, Chicago), and 

inside a transportation center (represented by Grand Central Terminal, New York). 

These scenarios were intended to replicate the scenarios outlined for BioWatch Gen– 

3 in its concept of operations document.24 This evaluation used results derived from 

earlier modeling efforts conducted by Sandia National Laboratories (SNL) and Los 

Alamos National Laboratories (LANL), which represented attacks with three biothreat agents (Bacillus anthracis, Yersinia pestis, and Francisella tularensis)25 and 

variable attack sizes, locations, and times of day. 

The operational scenarios were modeled to determine the amount of time required 

to detect and identify an agent, the time to establish a point of distribution (POD) 

to begin dissemination of prophylaxis, the probability that a given alternative would 

detect an attack, and the number of casualties resulting from the attack. Figure 2 

illustrates the modeling process used in this AoA. Life-cycle cost estimates were constructed independently for the four alternatives. Next, modeling and life-cycle cost 

estimates results were combined to evaluate Net Present Value and Return on Investment.26

c. Assumptions 

Several assumptions were included in the modeling process. They are as follows: 

1. Each biological surveillance alternative capability can be assessed independently or in combination with other capabilities. 

2. Three diseases—anthrax, plague, and tularemia—are assumed to be representative of the diseases in the BioWatch Gen–3 operational requirements 

document (ORD). 

3. Biological exposure and contagious spread (if any) are restricted and limited 

to specific geographical location/region where the release occurred. 

4. A BioWatch Gen–3 autonomous biological agent detector would be available 

for deployment in 2 to 5 years. 

5. One biological identification is a BioWatch actionable result. 

6. Casualty estimates are given in days (rather than hours) to avoid implying 

a higher level of precision than is supported by the relevant literature. 

7. Notional classes of capabilities are an appropriate representation of alternatives. 

8. Timeliness of the response is a function of when the public health intervention occurs as defined by the antibiotic prophylaxis points of distribution being 

opened to the public. 

9. Twenty-four hours is required from the decision to deploy the strategic National stockpile for antibiotic prophylaxis to the opening of the points of dis-
33 

27Mark Whitworth, RSS Analysis Project Final Report (Cambridge, MA: Center for Emergency Response Analytics, 2009), 7. 28 Roebert L. Stearman, Protection Against Chemical Attack Provided by Buildings, Technical 

Report DPG–S–TA–85–05 (Dugway, UT: U.S. Army Dugway Proving Ground, 1985). 29The versions of the outdoor and indoor transport and dispersions models employed in this 

study to estimate agent concentrations were unable to exchange data between one another, making it very difficult to transfer agent concentrations from one domain to another. 30See footnote 1 in ‘‘Certification of Acquisition Funding’’ (memorandum from Peggy Sherry, 

Chief Financial Officer, to Component Senior Financial Officers, Department of Homeland Security, December 2, 2012). 31DHS, Acquisition CONOPS for Gen–3, 45–47, FOUO. 32System sensitivity is the amount of mass of agent required to be present in a sample for 

it to be identified by a detector or in a laboratory process. 

tribution with an additional 24 hours to distribute the prophylaxis 27 for all candidate alternatives and excursions. 

10. The study assumes that antibiotic prophylaxis is distributed to the entire 

population on the day the points of distribution open; prophylaxis is effective 

1 day later. 

11. The population is assumed to be 100% compliant in taking the directed 

course of antibiotic prophylaxis. 

12. For the outdoor release, all individuals with a given aerosolized agent concentration at a given latitude and longitude receive the same exposure.28

13. Detections in a scenario are independent of any other nearby alternative 

employments (e.g., there are no outdoor detections for an indoor scenario).29

14. Casualties are evaluated as a function of exposure to a biological agent and 

the resulting symptomatic illness; mass casualty medical interventions are not 

included in the modeling. 

15. Life-cycle cost estimate calculations are made in U.S. Government fiscal 

year 2013 dollars, with results presented at the 50% confidence level.30

16. Each year in the life-cycle cost estimate is based on the fiscal year, which 

runs from October 1 to September 30 and program costs are incurred beginning 

on October 1, 2013. 

17. Estimates assume a 20-year operational life span beginning in fiscal year 

2014 and ending in fiscal year 2033, with full implementation of material solutions by fiscal year 2018. 

18. Material solutions were assumed to be deployed to 50 cities per the concept 

of operations for BioWatch Gen–3.31

19. The IDA team excluded the costs of construction/base operation of certain 

public health infrastructure, notably hospitals and analytical or clinical laboratory facilities. 

20. Estimates do not include either the cost of patient treatment once a decision 

has been made to establish points of distribution for prophylaxis or the cost of 

remediation (e.g., facility decontamination). 

21. Estimates include an information management system (IMS) that was developed and costed independent of each alternative. 

22. The cost of decommissioning hardware is assumed to be similar for all material systems. 

23. Unless otherwise noted, life-cycle cost estimates do not include the cost of 

equipment being further designed and developed using Government funds, assuming that solutions are fully developed and could be purchased from a vendor. Additionally, unless otherwise noted, test and evaluation costs are not included. Both these assumptions could increase life-cycle cost estimates. 

D. AOA PROJECT FINDINGS

1. Modeling Findings 

The biosensor alternatives—specifically Autonomous Identification, Environmental Collection, and the Sentinel Population alternative—would benefit from improved probability of detection. Probability of detection can be improved by either 

increasing the number of systems deployed (for the Autonomous Identification and 

Environmental Collection systems) or by increasing the sensitivity 32 of these systems. Improved probability of detection, however, may also increase system costs. 

For the biosensor alternatives in an outdoor attack, probability of detection is approximately 50% or less for attacks that cause 100 or more casualties and 65% or 

less for 10,000 casualties. Indoors, probability of detection is greater, approaching 

100% in those cases in which there are upwards of 10,000 casualties, resulting in 

less reliance on clinical diagnostics/diagnoses to trigger the distribution of prophylaxis. 
34 

33Detection-adjusted casualties estimates the expected number of casualties as a function of 

the probability of detection. It is a weighted average of casualties that occur when there is a 

detection and when there is no detection. 

In general, for attack scenarios modeled in this AoA: 

• All four alternatives demonstrated approximately equivalent availability for 

aerosolized biological agent events: i.e., equivalent coverage of 50 (or more) cities; ability to detect the five threshold BioWatch agents or more; and capability 

to operate in a variety of environments. 

• Autonomous Identification was consistently the quickest alternative to identify 

any of the three agents (at 6 hours), followed by the Sentinel Population alternative (generally at 18 hours), Environmental Collection (at 34 hours), and 

Clinical Diagnosis/Diagnostics (at 4–13 days, depending on the agent). Timeliness is illustrated in Figure 3. 

• Clinical Diagnosis/Diagnostics has the highest probability of detection (i.e., all 

agents will ultimately be detected) for both indoor and outdoor scenarios. 

• Environmental Collection and the Sentinel Population alternative approach 

99% detection indoors depending on the scenario. 

• The probability of detection for Environmental Collection and the Sentinel 

Population alternatives is less than 50% for the outdoor scenario; for Autonomous Identification, it is less than 25%. 

• More detail on the probability of detection results are in Figure 4. 

• For detected attacks, Autonomous Identification and Sentinel Population alternatives lead to the fewest casualties, followed by Environmental Collection and 

Clinical Diagnosis/Diagnostics, though the magnitude of differences between alternatives tends to be agent-dependent. Given the high concentrations found in 

the indoor scenarios, resulting in the more rapid onset of severe disease symptoms, the biosensor alternatives were less effective at reducing casualties for the 

indoor scenarios. 

• These casualty results are illustrated for anthrax and plague in Figure 5. 

Several factors have the potential to change these findings. They include sensor 

sensitivity, number of sensors deployed, number of detections required to initiate a 

public health intervention, frequency of sampling, new diagnostic protocols/tools, 

leadership’s willingness to act, different concept of operations and employment, and 

human behavior. There are also several non-quantified considerations that should 

be kept in mind, including false positive rates, situational awareness and characterization, rapidly confirmable information, possibility of exposure limitation through 

facility closure (indoor scenario), and the availability of forensic samples (wet or 

dry). 

2. Cost Findings 

Life-cycle cost estimates were developed based on the major cost drivers for selected candidate alternatives over the 20-year life span. The Sentinel Population alternative has the highest life-cycle costs, roughly an order of magnitude higher than 

Autonomous Identification and Environmental Collection, which are approximately 

equivalent. Clinical Diagnosis/Diagnostics, which assumes a pre-existing public 

health infrastructure and includes only the costs of testing (not treating) a small 

population of patients and the deployment of an information management system, 

is the lowest-cost alternative. The life-cycle cost estimates are illustrated in Figure 

6, with Clinical Diagnosis/Diagnostics as the least expensive option at approximately $43 million. Sentinel Population was the most expensive option ($16.4 billion). Environmental Collection and Autonomous Identification were estimated at 

$3.7 and $4.2 billion respectively. 

Cost-effectiveness was evaluated by comparing cost against a variety of effectiveness measures. Life-cycle cost estimates were compared to the probability of detection, the casualties for a number of representative attacks, and the detection-adjusted casualties.33 The Sentinel Population alternative often achieves the lowest 

detection adjusted casualties value, owing to its high probability of rapid detection 

and high cost due to its large number of samples. Conversely, although Clinical Diagnosis/Diagnostics has the highest probability of detection, the relatively long time 

before a detection can be obtained (and therefore extended time before antibiotic 

prophylaxis can be administered), results in the highest detection adjusted casualties value. Environmental Collection and Autonomous Identification are roughly 

equivalent in terms of cost and detection adjusted casualties for most scenarios. 

E. CONCLUDING REMARKS

The principal BioWatch AoA findings are: 
35 

34 ‘‘In June 2011, DHS provided a risk-adjusted estimate at the 80 percent confidence level 

of $5.8 billion [2010 dollars];’’ GAO, BioSurveillance—Reevaluate Mission Need, 3. 35 It is important to remember that the AoA used Gen–3 ORD values for Autonomous Identification sensitivity rather than a specific system data as no representative system has yet been 

selected. Demonstrated improvements in system sensitivity beyond those required in the Gen– 

3 ORD improve the system probability of detection and detection adjusted casualties as discussed in Section 6. 36 Bush, HSPD–10, 6. 

• Any biosurveillance solution involves a combination of material and non-material capabilities as well as defined doctrine and procedures to facilitate decisions 

by local and State leadership, and public health, law enforcement, emergency 

management, public works, transportation, and other public and private stakeholders. 

• Improved probability of detection for the biosensor alternatives options will result in earlier detection and decreased casualties and, therefore, lower detection-adjusted casualties. 

• Autonomous Identification, Clinical Diagnosis/Diagnostics, and Environmental 

Collection were all below the life-cycle cost constraint of $5.8 billion (as cited 

by the GAO).34 The Sentinel Population alternative exceeds the constraint due 

to the high number of deployed collectors and the associated laboratory and 

processing requirements. 

• The selected candidate alternatives were evaluated against a variety of metrics. 

These findings, as summarized in Figure 7, present a number of criteria which 

could, independently or in combination, inform future BioWatch discussions. 

The choice of alternative (whether Autonomous Identification, Clinical Diagnosis/ 

Diagnostics, Environmental Collection or a combination) depends on a variety of 

system factors, as well as factors with the potential to assist and influence decision 

makers using BioWatch system information. Table 1 shows several criteria that 

DHS might consider, independently or in combination, when selecting a BioWatch 

alternative and the corresponding system potentially best suited (given each criteria) for systems deployed outdoors, indoors, and in combined environments. 

There is a positive Net Present Value and Return on Investment for each of the 

four alternatives, depending on the perceived risk of attack and value associated 

with a human life. Clinical Diagnosis/Diagnostics is the least expensive alternative 

with the highest probability of detection but also is likely to result in the highest 

number of casualties due to delays in disease detection and identification. Indoors, 

both Autonomous Identification and Environmental Collection have roughly equivalent detection adjusted casualties values. Autonomous Identification shows reductions in casualties as compared with Clinical Diagnosis/Diagnostics for detected attacks due to the system’s timeliness of warning, while delays in warning for Environmental Collection are ameliorated by its higher probability of detection.35 Outdoors, Environmental Collection has the lowest detection adjusted casualties due to 

its higher probability of detection as compared to Autonomous Identification and its 

timeliness as compared to Clinical Diagnosis/Diagnostics. 

Insofar as there is a requirement for earlier warning and detection, employing a 

biosensor system according to a planned concept of operations—with appropriate response by decision-making authorities and timely engagement by public health officials—would yield fewer casualties and potentially non-quantifiable benefits, including forensic samples, rapidly confirmable information, situational awareness and 

characterization, and improved planning and preparedness. 

Homeland Security Presidential Directive (HSPD)–10, BioDefense for the 21st Century states: 

‘‘Early warning, detection, or recognition of biological weapons attacks to permit a 

timely response to mitigate their consequences is an essential component of 

biodefense... creating a national bioawareness system will permit the recognition 

of a biological attack at the earliest possible moment and permit initiation of a robust response to prevent unnecessary loss of life, economic losses, and social disruption.’’36

HSPD–10 is still in effect. This directive requires DHS to maintain a detection 

and early warning system. This Analysis of Alternatives provided DHS with information with which to evaluate alternate approaches to providing that capability. 
36 

REFERENCED FIGURES AND TABLES
37 
38 
39 

Mrs. BROOKS. Thank you, Dr. Disraelly. 

The Chairwoman will now recognize myself for 5 minutes of 

questioning. I will recognize other Members of the subcommittee 

for questions they may wish to ask the witnesses. 

In accordance with our committee rules, I plan to recognize 

Members who were present at the start of the hearing by seniority 

on the subcommittee. Those coming in later will be recognized in 

the order of their arrival. 

I would like to just confirm with everyone, or particularly, actually, with Dr. Brinsfield, Dr. Brothers, and Dr. Disraelly, do you 

think—simple yes or no—that bioterrorism continues to be a sig-
40 

nificant threat about which this Nation needs to be concerned? Yes 

or no? That is all I want to know. Dr. Brinsfield. 

Dr. BRINSFIELD. Yes, we continue to be concerned. 

Mrs. BROOKS. Dr. Brothers. 

Mr. BROTHERS. Yes. 

Mrs. BROOKS. Dr. Disraelly. 

Ms. DISRAELLY. Yes. 

Mrs. BROOKS. With a yes or no, do you believe, what you know 

now, that the Gen–2 system is sufficient? Yes or no? Dr. Brinsfield. 

Dr. BRINSFIELD. We believe the Gen–2 system works. We believe 

that a Gen–3 system would—or another system that did autonomous detection could be an improvement in the future. 

Mrs. BROOKS. Okay. Dr. Brothers. 

Mr. BROTHERS. Agree. I believe we get effectiveness from the 

Gen–2 system and believe we could have some improved capabilities with a Gen–3 system. 

Mrs. BROOKS. Dr. Disraelly. 

Ms. DISRAELLY. We believe that environmental collection is a viable alternative and that with improvements autonomous identification may be, as well. 

Mrs. BROOKS. Okay. Thank you. As I noted in my opening statement, the administration did release its National Biosurveillance 

Survey—Strategy rather in July 2012, and we are now coming up 

on 2 years and we have yet, as Mr. Currie noted, the plan for implementation of this important strategy was to be completed in the 

fall 2012. 

To date that plan has yet to be completed. It seems as if we have 

a National strategy but yet we have no implementation plan as to 

how to implement the strategy, that there has not been sufficient 

attention being driven to this problem. 

Dr. Brinsfield, can you share with us, having served on National 

Security Staff and now in your capacity, can you shed any light 

when this plan will be completed? If you could, please share with 

us what has caused this delay. 

Dr. BRINSFIELD. I think this plan—it would be honest to say that 

our staff is working diligently with the staff at the NSC right now. 

There is a rapid pace to this implementation plan’s development, 

and I have good faith that when it is released it will be a good plan 

and incorporate all the necessary elements. 

Mrs. BROOKS. What has taken 2 years? 

Dr. BRINSFIELD. I don’t think you could really say any one particular issue. I think it is important to make sure that you get all 

the different partners and agencies to the table and make sure that 

we have the right expertise and look at this data, the science. So 

I am very pleased with the progress it is making. 

Mrs. BROOKS. How many people are working on the plan? 

Dr. BRINSFIELD. On a regular basis in meetings, the meetings 

tend to be 10 to 20 people big. It depends. There are a lot of departments and agencies that participate. We have staff members that 

participate on a regular basis. 

Mrs. BROOKS. When can we anticipate the completion of the 

plan? In 2014? 

Dr. BRINSFIELD. Ma’am, I can’t answer that question, but I will 

be glad to work to get back to you. 
41 

Mrs. BROOKS. Who is in charge of it? 

Dr. BRINSFIELD. That would be at the National Security Staff for 

final release. 

Mrs. BROOKS. So who is in charge of it? Who is in charge? 

Dr. BRINSFIELD. Of the National Security Staff? 

Mrs. BROOKS. No, of the—who is responsible for ensuring there 

is an implementation plan that is developed? 

Dr. BRINSFIELD. Ma’am, I will get back to you. I don’t want to 

speak to their activities. I will get back to you with an answer, if 

I may. 

Mrs. BROOKS. Dr. Brothers, do you know? 

Mr. BROTHERS. I do not have an answer for that. Glad to work 

with Dr. Brinsfield to come up with an answer. 

Mrs. BROOKS. With respect to the Quadrennial Homeland Security Review—and this is for Dr. Brinsfield and Dr. Brothers—the 

2014 Homeland Security review includes a review of the biological 

threat landscape that we have reviewed and the Department’s 

strategy to counter these threats. It was—the Quadrennial Review 

was due to Congress by December 21, 2013. Do we have any idea 

when that will be submitted to Congress, Dr. Brinsfield or Dr. 

Brothers? 

Dr. BRINSFIELD. I am sorry, ma’am. Can you repeat the last part 

of the question? 

Mrs. BROOKS. When the 2014 Quadrennial Homeland Security 

Review, it was due to Congress end of 2013, but we have yet to see 

it. Are you familiar with this report? 

Dr. BRINSFIELD. Very familiar, ma’am, and that is why I was trying to make sure I understood correctly. Maybe Mr. Cummiskey 

can answer to the exact date of its release, but very familiar with 

the report and its finding. 

Mr. CUMMISKEY. Chairwoman Brooks, I understand that the 

QHSR is forthcoming. It should be here shortly in the not-too-distant future. I can’t give you a precise day, but it is intended to be 

here in the next 7 to 10 days. 

Mrs. BROOKS. Thank you. Will it address biothreats in the report? Do we anticipate that biothreats will be addressed in the report? 

Dr. BRINSFIELD. Yes ma’am, it does. 

Mrs. BROOKS. Okay. Thank you. We look forward to that. My 

time is up. 

Mr. PAYNE. Thank you, Madam Chairwoman. Excuse me. 

This question is for Dr. Brinsfield and Dr. Brothers as well. You 

know, after DHS canceled the Gen–3 acquisition, the Secretary directed the Office of Health Affairs and Science and Technology Directorate to complete two reports within 2 weeks of the April 2014 

ADM. 

One report is to address lessons learned and the other is to lay 

out a strategy moving forward. It has been a month-and-a-half 

since the decision to discontinue Gen–3 was announced. What is 

the status of those reports requested by the Secretary and why 

have the documents been delayed? 

Dr. BRINSFIELD. We have been working very closely on those documents. We have actually submitted those documents for Department review. 
42 

Mr. PAYNE. Okay. Can you give us an idea or sense of the major 

findings or strategies that will be included? 

Dr. BRINSFIELD. I think in the first report that looked at history, 

I would concur with much of what has been discussed here today. 

We looked at how information is generated, requirements are generated, looking forward to a coordinated process in that effect. 

Also looked at how the acquisition process moves forward and 

how we can make sure that the best decisions are being made. In 

the second report, I will defer in a second to Dr. Brothers, but I 

think what we have agreed to is looking together in a collaborative 

fashion at how we can move forward in the technology space. 

Mr. BROTHERS. Yes. I think we have talked to kind-of a nearterm and a far-term look at this. Where in near-term we are looking at what we can do to augment the current system. Then in the 

far-term what we can do to look at increased capabilities, maybe 

distributed, a sensor-agnostic type-of system. So we are working together to try to flesh those things out. 

Mr. PAYNE. Okay. Dr. Disraelly, in your testimony you note that 

the IDA team identified about 500 technologies that are either 

readily-deployable or in development, and that ultimately you narrowed it down, the available technologies, to four for purposes of 

the AOA. Can you talk about some of the technologies that were 

not selected to be considered for the AOA and why? 

Ms. DISRAELLY. The 500 technologies and capabilities that we included, or that we mentioned, included activities, programs, and 

technologies themselves. We sorted those into 29 classes of capabilities. So basically like was sorted with like. 

One example of a technology, for example, that was not included 

was social media. Social media gets a lot of attention right now as 

an epidemiological tool and a tracking tool in the public health sector. 

However, people aren’t reporting on social media until after they 

have actually been diagnosed with a disease, and therefore it 

doesn’t have the timeliness factor that clinical diagnosis and 

diagnostics does because we would already know that the disease 

was present, before social media actually was able find it. Does 

that give you an answer? 

Mr. PAYNE. Okay. Let’s see. In terms of the GAO, Dr. Brinsfield, 

they observed that the National Academy of Sciences has raised 

questions about the effectiveness of the currently deployed Gen–2 

BioWatch system. You know, other critics have raised concerns regarding whether Gen–2 addresses the threats raised by our intelligence community. Members of this panel have historically raised 

similar concerns. 

What efforts will you take to examine and reevaluate the concerns as you consider replacing Gen–2 equipment? We know that 

it was stated this morning already that some of that equipment is 

coming to the end of its life cycle or its usefulness. I think technology has moved dramatically in terms of what is possible in this 

area since Gen–2 was implemented. So could you speak to that? 

Dr. BRINSFIELD. Sure. I will speak briefly and then turn it over 

again. First, to the question of does the current system work, we 

have data analyzing its current effectiveness that we would be 
43 

happy to share with the committee environment, if you would like 

us to come back. 

In terms of future threats, I think exactly as Dr. Brothers was 

saying, as we look at the future technology we want to make sure 

that it covers a broader array and that we think broadly about 

what the current risks are. 

Mr. BROTHERS. Yes. I mean, I think some of the fundamental 

things we are looking at going forward are getting greater confidence in our systems so that the leadership has to make decisions 

of what to do when these events happen that they have greater 

confidence in the answers. A shorter time frame, because I think 

we were talking earlier about casualty rates and the importance of 

early detection. 

So those are some of the things we are looking at. Whether we 

go from signature detection to more anomaly detection, there are 

different ways of thinking about the problem and we will be looking at all of those. 

Mr. PAYNE. From what I understand is that you would need a 

large aerosol pathogen to go through the system in order to detect 

it. What if you had a lone wolf-type situation? Would the system 

be able to capture that? Then the collection time is something that 

we need to consider, 24 to 36 hours before we could collect and 

identify that there is an issue. That is a pretty lengthy amount of 

time. 

Dr. BRINSFIELD. Yes. I think we are going to look at all those 

issues as we move forward, both shortening the collection time, increasing the number of agents, and looking at different environments, whether it is just a broad aerosol environment, an indoor 

environment or other types of environments. We might want to do 

a collection. All of these are questions that have been looked at and 

raised and will be good questions to work together on going forward. 

Mr. PAYNE. Okay. Well I hope, you know, based on where we are 

and the technology that we can—you know, we are starting all 

over. We have been working on I guess the Gen–3 really since 2003 

maybe. So it is about a decade, and now we are going back to the 

drawing board. 

It is very disturbing to have that situation arise now and knowing that the technology that we are using—I mean, if we started 

looking at Gen–3 a decade ago, then, you know, what does it say 

of Gen–2 and where it started? You know, we need to really find 

a way to get moving in terms of the technology before we have a 

calamity occur. 

I will yield back. Sorry. 

Mrs. BROOKS. Thank you. 

At this time the Chairwoman now recognizes Vice Chair of the 

committee, the gentleman from Mississippi, Mr. Palazzo, for 5 minutes of questioning. 

Mr. PALAZZO. Thank you, Madam Chairwoman. 

Secretary Cummiskey, the Department has had a number of 

failed acquisitions over the course of its relatively short existence, 

SBInet, Emerge, and the ASP program, and now Gen–3. I applaud 

the Secretary for canceling a program that was not working. 
44 

What have we learned from each of these failed acquisitions that 

will help us avoid similar mistakes in the future, and what policies 

have you put in place to ensure more robust acquisition oversight? 

Mr. CUMMISKEY. Thank you, Congressman. 

We have taken a number of steps over the last several years to 

strengthen the entire life-cycle continuum. We started with oversight because that the area where we are already working with 123 

other major acquisitions in the Department. 

So what we have tried to do is strengthen that by creating the 

program acquisition and risk management entity within management, which is the acquisition oversight arm. We created the chief 

acquisition executive process in each of the components in order to 

make sure that they are invested in this or working in concert with 

the folks that are actually operators on the ground that are deploying these systems. 

We have also worked closely on strengthening life-cycle cost estimating by shifting that function out of harm, the program accountability group, into the chief finance office of the Department so that 

we can get stronger life-cycle cost estimates in that oversight bucket. 

The Secretary has called for a Unity of Effort in this area and 

so what we are doing is we are shifting our focus now to strategies 

and plans as well as joint capabilities and requirements development so that when you are feeding the oversight piece, we have got 

stronger pieces of the continuum, which we are going to reduce the 

likelihood that would be less successful. 

Mr. PALAZZO. Okay. So you said you are going to continue to refine your acquisition oversight framework as a part of the Unity of 

Effort. 

Can you elaborate on some of the things that you are refining 

now? 

Mr. CUMMISKEY. Absolutely. 

Congressman, first of all, let me thank the entire House and particularly the committee for the leadership on 4228. That piece of 

legislation will go a long way in codifying many of the things that 

we have tried to put into place in the oversight function. 

What the Secretary is saying is that in terms of looking at the 

requirements, we have got to take a joint requirements perspective 

on this and not just have one component or office, you know, trying 

to develop that. So what he has called for is the development of a 

joint requirements council, which, again, I think the full committee 

has called for in the past, which would give us an opportunity to 

sit together and look at best practices in the space, strengthen the 

joint requirements so that when we are feeding the resourcing 

piece, we will have a better sense of what we are actually buying 

and increase the likelihood of success. 

Mr. PALAZZO. Now both DOD and DHS S&T have been studying 

and developing environmental detection systems for some time. 

Before deciding to begin the development of Gen–3 systems, did 

the BioWatch Program look at these existing systems and if so, 

what type of analysis was done to determine that BioWatch needed 

to develop its own technology? Can any of these systems be leveraged now to make improvements to the current system? 

That is for Dr. Brinsfield, Dr. Brothers, and Mr. Cummiskey. 
45 

Dr. BRINSFIELD. So there was an integrated planning team that 

did meet in the early stages of this that included other departments and agencies providing input. 

I will note that as of now, the Department of Defense is actually 

using some of the current Gen–3 equipment to test against their 

current system so we hope to have that information. 

Mr. BROTHERS. I think that we have a good relationship with the 

Department of Defense. I think we look forward to leveraging those 

to work together in fielding the best system possible. 

Mr. CUMMISKEY. Congressman, to be candid with you, we went 

back into some of the documentation that was essential to launch 

this successfully. It was not there. We had to go back and do the 

AOA, the other documentation around operational requirements 

and things of that nature. 

So what we have done now is for the last 3 years, no program 

has advanced without making sure we are hitting those gates in 

concurrence with what the GAO has called for. So we are in a better position. We would anticipate going forward that all of that will 

be in place for Gen–3. 

Mr. PALAZZO. Thank you. 

I yield back. 

Mrs. BROOKS. Thank you. 

At this time, the Chairwoman now recognizes the gentleman 

from South Carolina, Mr. Sanford, for 5 minutes’ questioning. 

Mr. SANFORD. Thank you. 

It strikes me that you could have the greatest technology in the 

world but if you didn’t have appropriate and proper human infrastructure to manage that technology, you would still have a very, 

very serious, even gaping security hole. 

So with that in mind, I listen to your answers to the Chairwoman’s questions, simple questions on implementation and your 

answer, Dr. Brinsfield, your answer, Dr. Brothers, was ‘‘I don’t 

know, and I don’t know.’’ 

It just strikes me that that is the kind of mismatch between 

technology whether talking Gen–2 or Gen–3 that is quantitative, 

real, in some cases, proven, in some cases, not proven with a 

human infrastructure, which I think has been a lot of people’s beef 

with homeland security as you look at different GAO reports and 

what-not. 

Let me just go back to that question one more time because the 

Chairwoman asked, I thought, a fairly basic question on implementation. Why wouldn’t you know? 

Dr. BRINSFIELD. So, sir, I think we do a lot of work and work 

very hard with our State and local partners to make sure that both 

the BioWatch Program and the NBIC are very well-integrated with 

their strategies and where they are moving forward. I think the 

important thing to focus on here is the amount of time and effort 

we give to supporting the boots on the ground and the people that 

have to actually do the response, the first responders—— 

Mr. SANFORD. If I could respectfully interject, I have actually sat 

in that role and at a State level. A lot of times, we were driven by 

Federal mandates in terms of different benchmarks that they had 

laid out with regard to level of implementation. 
46 

So I mean, I had 8 years of experience in that particular regard. 

So respectfully I would disagree. 

Is there integration? Absolutely. But in many cases, we were responding at the State level to what the Feds had laid out in terms 

of benchmarks. I don’t understand why there wouldn’t be, at least, 

benchmarks, at a minimum, benchmarks with regard to implementation to the Chairwoman’s question. 

Dr. BRINSFIELD. So I am very interested in hearing your perspective, and I would like to offer to get together and discuss this with 

you in the future. I think anything we could do to improve those 

relationships would be a good thing. 

Mr. SANFORD. But that is still not answering the question on implementation. 

Dr. BRINSFIELD. For implementation in terms of the strategy to 

move antibiotics into an area after release, there is a program 

within the CDC that measures that and does a very good job working with States and locals to provide benchmarks and measure 

that. 

In terms of BioWatch, we have a very active group that is working on CONOPS with the State and locals both for outdoor and indoor monitoring to provide those benchmarks. 

Mr. SANFORD. Again, respectfully, one of the things I often times 

say to my staff is, look, fewer words, more facts. 

I guess I would put this in the same category. I am getting a lot 

of process but still no benchmarks in terms of the question the 

Chairwoman asked, which was, ‘‘Is there not any date specific in 

terms of the implementation’’? 

Dr. BRINSFIELD. You are asking on an implementation plan date 

release, which is an interagency process. Sir, I apologize but I can’t 

give you a hard date on an interagency document. 

Mr. SANFORD. But a ballpark? 

Dr. BRINSFIELD. I would hope it would be released in the near 

future, sir. I know we are working very hard towards that end. 

Mr. SANFORD. Any further illumination from your—do you understand my frustration? It just seems like it is what people hate most 

about Government, which is process, process, process, and process, 

with no sort of—okay. 

I mean, I think that one of the things that people really admire 

about the military and the disjunction between the times where the 

military is perceived and where Homeland Security is perceived is 

that they will flat out give you a target. This is what we hope to 

do by this date. This is what we hope to do by this date. This is 

what we hope to do by this date. 

They may or may not hit those benchmarks, but they will give 

you at least what they are shooting for. What I am hearing from 

your end is it is a process, and we are in that process. I think people find that very, very frustrating. 

With that, I yield back. 

Mrs. BROOKS. Thank you. Kind of building on that a little bit, I 

would like to—Mr. Currie, you talked about the fact that GAO 

found that, at least in 2012, DHS had no policies for defining and 

coordinating R&D. There are a lot of different groups within Homeland Security, and we have some new leaders here in Dr. Brinsfield 

and Dr. Brothers. 
47 

Can you share with us what GAO’s recommendations were with 

respect to coordinating and the fact that all the technology, and I 

know it takes a lot to develop technology, but then to transfer it 

into implementation, but S&T had had no tech transfer that was 

successful. So what would we say should be happening within 

DHS? 

Then I would like to go to Dr. Brinsfield and Dr. Brothers for 

more clarification about how you now are going to coordinate this 

plan so that we, as a country, and we as Congress can have more 

comfort than we do right now, that there is real technology R&D 

discussions and real implementation with respect to bioterrorism, 

which is very real and we have very great concerns about what is 

not happening. 

Mr. Currie. 

Mr. CURRIE. Thank you, Chairwoman Brooks. 

You are correct. In 2012, we reported that DHS had no policies 

for coordinating or really managing its R&D investments, not just 

within S&T but across all the components. I liken the R&D situation at DHS to what the acquisition situation was at DHS probably 

8 or 10 years ago when there were no acquisition policies. 

The Department, as Mr. Cummiskey has outlined, has taken 

many steps to outline that they have new policies and practices for 

following those. 

In R&D they have gotten a little bit of a late start on that. It 

is very similar. So let me give you an example of that. For example, 

a couple of years ago DHS had no definition for what R&D at the 

Department was. Other agencies like DOD or NASA use technology 

readiness levels and other things to define R&D. DHS did not have 

a common definition. 

So—— 

Mrs. BROOKS. Would you agree—just to interrupt briefly—that in 

any development of anything new, the R&D costs, thereby the costs 

to the taxpayers, are often the highest in the R&D process? 

Mr. CURRIE. Well, it is true. It costs a lot to research and develop 

technologies. But it is why we think it is very important and what 

we recommended is that they develop these policies for what R&D 

is going to look like through the life cycle, what S&T is going to 

do, but more importantly, what is going to happen when they 

transfer it to the components, and when is that going to happen? 

I think on this issue we are talking about today, on BioWatch 

and biodetection, it is going to be very important that very early 

on S&T and NAFSA health affairs agree very early what is going 

to actually happen, what both parties are going to do, and when 

that transfer is going to occur. 

Mrs. BROOKS. Thank you. 

So, with that, Dr. Brinsfield and Dr. Brothers, I have tremendous 

respect for your qualifications for the offices that you are both holding and with your experience. So can you please share with us— 

and I applaud the Secretary’s unity of effort charge—how is it 

going to work? 

Mr. BROTHERS. So let me start off with one of the comments that 

was just made. We do actually have an R&D definition now. So I 

think that is very helpful. Because as you mentioned, without hav-
48 

ing that kind of definition, it is very difficult to try to understand 

what we are talking about, right? 

But we now do have a definition. You mentioned the NASA and 

DOD TRL, technology readiness level, way of looking at it. That is 

exactly the type of thing we have adopted. So we have the same 

kind of 6–1 to 6–7 type-of designation the Department of Defense 

does. 

So that is going to be very helpful in us actually understanding 

what is going on across the Department. 

The other piece here that is important to think about is in the 

6 weeks that I have been there, I have made a point to actually— 

meeting with the component leads to try to understand what their 

needs are and also what is going on. I am in the process of that 

right now. 

Part of this process of working with Dr. Brinsfield is understanding exactly the types of activities we have going on and what 

we should be doing going forward, as well. 

So I think I mentioned earlier that there is this emphasis on 

near-term versus far-term. So particular to BioWatch is there will 

be a near-term effort that we will be looking at, trying to understand what we can do with existing capabilities, how we are going 

to augment those. There is a longer-term effort, as well. 

I think I also mentioned that from an S&T perspective we are 

looking at doing a potential apex program to really try to figure out 

how we can push this technology. 

But I think going back to this point of coordinating S&T, I think 

the roots—the basis of being able to do that is this definition and 

communication and collaboration with the component heads. That 

is part of what the Secretary’s Unity of Effort call to action is all 

about. 

So I am very confident that we can do this going forward. 

Mrs. BROOKS. Dr. Brinsfield. 

Dr. BRINSFIELD. We have already had numerous conversations 

about sort-of the big picture where we see this going forward. I 

think it is a good relationship. We are working well together. The 

staffs are working well together. I look forward to a structured 

joint requirements process. I think this will help to answer much 

of the issues. 

Mrs. BROOKS. Dr. Disraelly, have you been consulted in—with respect to your report by OHA and by S&T on what your analysis 

was and what the alternatives were that your Institute has presented? 

Ms. DISRAELLY. At several points during the study, all the way 

from its inception, all the way through its conclusion, we briefed 

several members of the Department of Homeland Security. 

We had a stakeholder team that included nine organizations 

within the Department who were given the opportunity to participate in the briefings as well as comment on the documents as we 

went through. 

Mrs. BROOKS. Did you feel that they were high-level individuals 

within DHS that participated? Or do there need to be additional 

meetings with respect to all of the work that your organization did? 

Have you met with Dr. Brothers? 
49 

Ms. DISRAELLY. We have met with Dr. Brinsfield. The study was 

concluded before Dr. Brothers came to the Department, and so we 

have not briefed with him. 

Mrs. BROOKS. Okay. I am certainly hopeful that all the work and 

I appreciate that you are new, but that collaboration can—with the 

analysis that has already been done, because it seems as though 

you are stepping into an organization that has not had much success in its tech transfer and in its implementation of the technologies it studied, if Mr. Currie’s analysis of past work from S&T 

is correct. 

So, I certainly hope that those discussions will happen very, very 

quickly. We look forward to your near-term goals being set as well 

as future goals. 

With that, my time is up and I would turn it over to Ranking 

Member Payne for 5 minutes. 

Mr. PAYNE. Yes, thank you, Madam Chairwoman. I was going to 

mention that Dr. Brothers, I am concerned that you haven’t been 

able to straighten all this out in 6 weeks. 

[Laughter.] 

Just to that point. 

But Under Secretary Cummiskey, I am concerned that the Department did not engage in a thorough Analysis of Alternatives 

until the acquisition of Gen–3 was well underway. I am glad that 

it has suspended the acquisition to reevaluate when GAO raised 

the red flags in 2012. 

Can you tell the subcommittee how much money has been appropriated to Gen–3 and how much of the funding that has already 

been obligated and what the Department plans to do with the 

funds appropriated to Gen–3 that have not already been obligated? 

Mr. CUMMISKEY. Thank you, Ranking Member Payne. 

With regard to the expenditures, I checked with the CFO’s office. 

The amount that has been spent on Generation–3 since 2009 is $61 

million. Of that, it was spent primarily on evaluation and testing 

capabilities. There was some money spent prior to 2009 on other 

aspects of BioWatch. But as to the question of Gen–3, it is $61 million. 

Mr. PAYNE. Okay. And the dollars for Gen–3 that haven’t been 

obligated? 

Mr. CUMMISKEY. There were $16 million that were unspent as 

part of the appropriations and were routed to the Treasury. 

Mr. PAYNE. Back to Treasury? 

Mr. CUMMISKEY. Yes. 

Mr. PAYNE. Okay. All right. Let’s see. Also, this is a little bit offtopic, but since I have a captive audience I will take the opportunity. 

As you know, I have introduced legislation to resolve inter-operability communication problems within DHS, first identified by the 

inspector general in November 2012. 

This legislation is H.R. 4289 and will be marked up by the full 

committee tomorrow, as a matter of fact. 

Have you seen this or reviewed this legislation? Can I count on 

you to work with me to address this important issue? Because any 

time I am involved in crafting legislation, I try to get as many peo-
50 

ple involved to help it be good legislation, so when it is finally presented all sides have had an opportunity to weigh in on it. 

Your thoughts? 

Mr. CUMMISKEY. Sure. Congressman, I had an opportunity to review 4289 last evening. Just on a personal note as a former State 

Senator who spent a lot of time on inter-operability issues, I really 

applaud and appreciate your efforts. We look forward to working 

with you to advance what is really an essential role for the Department. 

Mr. PAYNE. Absolutely. I mean, based on the information that I 

have learned and gathered since coming to this committee and the 

Congress that the whole question around inter-operability throughout agencies and to the States and locals is crucial in order for continuity in addressing the safety of the homeland. 

So I thank you for that. 

Also, it seems that one of the problems—okay. Never mind. 

Dr. Brinsfield, the BioWatch is currently deployed in 30 cities. 

Under Gen–3 the program was expanded to 50 cities. What was the 

rationale behind expanding the program to 50 cities, and was it 

based on specific intelligence suggested that such an expansion was 

necessary? 

Dr. BRINSFIELD. Sir, when the program was proposed to be expanded, it was working off lists provided by the FEMA grants initiative as to cities that would be possibly at risk and covered under 

that program. 

That list has since been moved back. 

Mr. PAYNE. Okay, so expanding to the 50 cities is not a priority 

or will it continue to be a priority? 

Dr. BRINSFIELD. Sir, we don’t currently have funding to expand 

in that area. 

Mr. PAYNE. Okay. 

Okay, Madam Chairwoman. I yield back. Thank you. 

Mrs. BROOKS. Thank you. 

With respect to—because it sounds as if the current system, 

Gen–2 is going to be in place for some time with no really new systems having been identified on the horizon or certainly submitted 

in any budget request, speaking of funding, which might also be, 

in part, because the administration has yet to produce the plan. 

But with that said and to ensure that Gen–2, the GAO do make 

any recommendations with respect to improvements to Gen–2, Mr. 

Currie? 

Mr. CURRIE. No, ma’am. Actually, most of our focus has been on 

the Gen–3 acquisition—— 

Mrs. BROOKS. Do you have any recommendations for Gen–2 at 

this point? Are you prepared to make any recommendations with 

respect to Gen–2, which is what we have in 30 cities? 

Mr. CURRIE. Currently, we have work on-going looking at the 

technical capabilities of Gen–2, which may result in recommendations. But at this point, we don’t have any specific reported recommendations. As I laid out in my testimony, we have many questions and concerns about what is going to happen with the program, but this has all happened so recently that it is very unclear 

what is going to transpire at this point. 
51 

Mrs. BROOKS. Dr. Disraelly, do you have any recommendations 

with respect to the current system improvements? 

Mr. CURRIE. No, ma’am. That was outside the scope of our study. 

Mrs. BROOKS. Okay. So, Dr. Brinsfield, Dr. Brothers, and I do appreciate our recent visit to the NBIC, which was very enlightening 

and I want to thank you and your staff for putting on a very—you 

know, a wonderful presentation about NBIC. But what improvements might you have or suggestions that should be made to the 

Gen–2 system, in order to make it the most efficient and best system, if that is what we have got right now? 

Dr. BRINSFIELD. Thank you, ma’am, and Mr. Payne for your visits. We greatly appreciated you coming to the NBIC. We are looking at a number of issues that we will be coordinating with Dr. 

Brothers staff as well. Some of them are about how we collect the 

samples. Some of them are about the form that the samples are 

collected in, so that might provide more information. Some of them 

are about giving us a warning, if something might have been released early so that we could go and take a look at the sample earlier. 

All those—there are about seven of those different potential incremental improvements to the current system and we are looking 

at them as we speak to see which we could field in the near-nearterm. By that I mean, within the year or so and others that we 

might be able to implement in the near-term. 

Mrs. BROOKS. Might you be considering detectors and use by 

other Federal agencies as well to supplement the current Gen–2 

system? 

Dr. BRINSFIELD. There are different types of detectors that we 

have looked at in different Federal agencies. As you know, we have 

looked at studies done by a number of different groups to look at 

what is currently in place and using the technology readiness levels, you know, what could be fielded now. There isn’t a start-to-finish detector in another agency that would be better than our current system. So that is where we are at looking at improvements 

to the current system. 

Mrs. BROOKS. Dr. Brothers, I do appreciate that you would only 

been there 6 weeks. But in your—and having been in new positions 

in the past in kind of order of priority, where does the Gen–2 and 

the BioWatch program, you know, fall in S&T? 

Mr. BROTHERS. You understand, it is clear to me the importance 

of this capability, the threat that bio poses to the country. You 

know, right now about 25 percent of our budget is spent in chembio. So I think just based on that alone, you can see, it is a large 

priority for us. 

So yes, it is important. I think it is also to consider the nearterm. I think the comment came up earlier about, you know, how 

this is used. I think, you know, taking a system-to-system approach 

both near-term and far-term is important. 

Mrs. BROOKS. Dr. Brinsfield, can you share with us briefly, how 

is BioWatch and NBIC working together? 

Dr. BRINSFIELD. Yes, ma’am. 

I know we discussed this when you came to visit and for us, it 

is a high priority to make sure that the two are working together. 
52 

BioWatch is a tool, a very useful tool that gives us a data-point 

in which we can look at to see if there has been a biological event. 

NBIC or the National Biosurveillance Integration Center looks at 

this from the continuum, from early through, with the departments 

and agencies collecting all information available. 

It is our role in this next bit of time to see how we can make 

the two, use the two more efficiently to work together. We already 

use the two on a daily basis to provide information to both States 

and locals to the White House and we are looking at how we can 

sort of institutionalize that coordination. 

Mrs. BROOKS. Didn’t you indicate at that time that the personnel 

over—with responsibility for BioWatch were moving to NBIC’s site? 

Dr. BRINSFIELD. Yes, ma’am. 

One of the ways we are going to work on that collaboration issue 

is to make sure that all personnel are housed in the same area so 

they can have those day-to-day conversations more easily. 

Mrs. BROOKS. Then also can you—the current BioWatch detectors that are currently deployed, how is that information provided 

to NBIC so that it can be disseminated to State and local authorities? 

How does that work from the BioWatch collection to NBIC to 

State and locals? 

Dr. BRINSFIELD. So speaking to the BioWatch CONOPS as was 

previously mentioned, there is a way that the States, locals, Federal agencies, all of which have a role, including NBIC and NBIC’s 

partners, can participate in an information call when you have 

positive results from one of the BioWatch. 

It is meant to set it up so that you can put it in perspective of 

what else people are seeing, what is going on and make sort-of a 

collaborative decision on the path forward. That process has been 

in place for a number of years and has been tested numerous 

times. It is something that we work very hard to make sure we are 

doing this in collaboration all the way through our health and 

human services partners, USDA and others back to the field and 

States and locals. 

Mrs. BROOKS. Thank you. 

My time is now up—for 5 minutes of questioning from the Ranking Member. Okay. 

If I might have one moment, please? 

At this time, we have no further questions. 

I do want to thank all of the witnesses for their valuable testimony, both that was written and your answers to our questions 

today. 

Members of the subcommittee may have some additional questions for the witnesses. We will ask you to respond to those in writing. 

I just would like to close by reiterating as I began, the importance of the administration providing the implementation plan for 

the National Biosurveillance Strategy. 

Additionally, it is very difficult. Congress wants to be a strong 

partner in ensuring that our country is safe from bioterrorism 

threats and I believe that from this committee, in a bipartisan way, 

we are very concerned that we don’t have the plan from the administration forward. 
53 

We are in the dark as to what the administration wants funded 

and what the needs are in the country. We don’t believe that the 

threat is diminishing around the world and we look forward to receiving those plans and also look forward to continuing discussions 

in the Classified manner in which you suggested. 

So at this time, pursuant to committee rule 7(e), the hearing 

record will be open for 10 days. 

Without objection, the subcommittee stands adjourned. 

Thank you. 

[Whereupon, at 11:20 a.m., the subcommittee was adjourned.] 

(55) 

A P P E N D I X 

QUESTIONS FROM CHAIRWOMAN SUSAN W. BROOKS FOR KATHRYN BRINSFIELD AND

REGINALD BROTHERS

Question 1a. On November 22 of last year, several Members of the committee 

wrote a letter to DHS to ask about progress made in looking at the coordination 

of programs and activities with Weapons of Mass Destruction, Chemical, Biological, 

Radiological, and Nuclear responsibilities. This letter cited the fiscal year 2013 DHS 

appropriations bill report language that requested DHS to submit a consolidation 

plan to merge the Domestic Nuclear Detection Office (DNDO) and the Office of 

Health Affairs (OHA). We received a response from Secretary Johnson stating that 

‘‘I have directed my staff to begin working on several initial focus areas that are 

intended to build organizational capacity in support of our primary objective: the effective and efficient execution of our mission.’’ 

Can you please provide us an update on that progress? 

Answer. The Department of Homeland Security (DHS) continues to explore alternatives to re-orient and re-invigorate several headquarters functions and organizations to meet the intent of the Secretary’s Unity of Effort initiative and its ultimate 

objective: Empowering DHS components to effectively execute their operations. 

Science and Technology (S&T), OHA, DNDO, and the rest of the Department have 

been working together closely to analyze a range of possibilities for closer coordination of chemical, biological, radiological, and nuclear (CBRN) responsibilities. DHS 

is considering a number of viable options, but we are not prepared to suggest one 

particular path forward at this time. 

Question 1b. Do you believe that the Weapons of Mass Destruction (WMD) functions of DHS would be better consolidated than in separate offices? 

Answer. There are advantages and disadvantages to both options, and those will 

be articulated to the Secretary to inform his decision on organizational changes. In 

the mean time, the offices with WMD responsibilities will continue to coordinate 

closely on matters of mutual interest, whether related to policy, budget, acquisition, 

plans, or operations. 

Question 2a. Your testimony refers to the business model used by the BioWatch 

program. This model, as you described it, uses the BioWatch units that are provided 

by the Federal Government and then ‘‘a network of local, State, and Federal laboratories.’’ Much focus has been placed on the acquisition and technology of BioWatch 

but I am also interested in hearing about challenges in using this type of approach. 

Do you think that this model still works today? 

Question 2b. What challenges exist in using this model? 

Question 2c. Do you plan on looking at alternatives to this model moving forward? 

Answer. BioWatch is a tool of the public health and first/emergency response communities. The network of local, State, and Federal laboratories and stakeholders is 

an essential element of the program. These partnerships include public health, 

emergency management, first responders, law enforcement, and laboratory officials. 

This model has proven to be a successful integration of a Federal program operating 

at a State/local level that allows all partners access to the information and tools 

they need to make informed and timely decisions, while staying consistent with local 

response operations. We work in partnership with transit agencies, local police departments, health departments, etc. to build effective networks within each jurisdiction. The communications and exercises conducted with these networks through the 

BioWatch program build personal and professional relationships within this community and improve the ability at all levels of government to respond to a large-scale 

bioterrorism attack. Each jurisdiction has a multi-agency group that coordinates the 

implementation, routine operations, and enhancement of their jurisdictional 

BioWatch program. Recent reductions in State and local funding have led to challenges for public health departments, who have to carefully balance their resources 

among competing priorities, and have prevented some communities currently out-
56 

side the network from joining the program. Additionally, each jurisdiction has specific needs and protocols that make it difficult to adopt a standardized approach 

across the entire BioWatch network. 

Potential technology changes may alter the current program processes. In cooperation with S&T, the BioWatch program is examining as a near-term strategy 

several technology approaches which essentially keep the current collector-laboratory approach, but upgrade the technology used in aerosol collection, the laboratory 

identification methods, or both. Any improvements would be predicated on efficiency, timeliness, and cost considerations. As longer-term alternatives are developed, alterations to the current model may be considered that would be contingent 

on improving efficiency, timeliness, and/or decreasing costs before being deployed. 

Question 3a. As you work to identify and develop alternatives to the Gen–2 system, and appreciating the critical role technology providers in industry can play in 

advancing this technology, what are you doing to communicate with the private sector regarding the way ahead for the advancement of detection systems so they can 

participate in this effort? 

Answer. Any new acquisition of technology will be conducted in accordance with 

the DHS Acquisition Management Directive 102–01 (MD 102–01) acquisition process to emphasize transparent, full, and open competition. The BioWatch program 

has discussed potential technology approaches with the commercial sector and has 

met with industry representatives, when appropriate, to discuss needs and available 

technologies for potential implementation. Potential Gen–2 enhancement efforts will 

largely be executed through traditional acquisition instruments such as Requests for 

Information, Broad Agency Announcements (BAAs), and scheduled ‘‘Industry Days’’ 

that allow direct discussion of BioWatch technical needs with multiple industry representatives. As one example, S&T’s recently initiated investigation of detection networking architectures began with an Industry Day to allow discussion of concepts 

with industry, and a BAA-enabled industry to describe concepts for funding consideration. In addition to these traditional mechanisms, S&T looks forward to taking 

advantage of its newly-delegated prize authority to engage and harvest performers 

through a potential biosurveillance grand challenge. 

Under the new leadership of Dr. Brothers, a priority for S&T has been finding 

more effective ways to harness the energy and expertise of the Homeland Security 

Industrial Base. Working better with industry is essential to developing near- and 

long-term solutions to homeland security problems. Part of this effort over the last 

2 months has involved development of a homeland security science and technology 

strategic document that lays out visionary near- and long-term Research and Development (R&D) goals that will, among other purposes, serve as hooks for engaging 

industry. The strategy is also supported by on-going development of technology road 

maps by S&T’s research divisions in S&T’s major investment areas. When completed, the strategy and road maps will be valuable tools for communicating S&T’s 

investments and vision, including where perceived gaps and opportunities may lie, 

and driving complementary investment by industry stakeholders. 

Question 3b. How are you communicating with State and local officials to discuss 

their needs going forward? 

Answer. The BioWatch Program is communicating with State and local partners 

on the status of technology upgrades within BioWatch and working with them to 

assess their needs through a number of channels. These include webinars and program updates to inform all BioWatch jurisdictions as well as Federal partners of 

the current status of the BioWatch program and the cancellation of the Gen–3 acquisition. Daily interactions by the jurisdictional coordinators who serve as liaisons 

in each BioWatch Jurisdiction and the implementation of new technologies under 

consideration will be discussed at length as part of the National BioWatch Workshop in October 2014. In addition, the BioWatch program staff attend and discuss 

needs with BioWatch Advisory Committees (BACs are multi-agency groups that coordinate the implementation, routine operations, and enhancement of their jurisdictional BioWatch program) during regularly-scheduled BAC meetings throughout the 

year and will also discuss jurisdictional needs while attending exercises held within 

the BioWatch jurisdictions. The BioWatch program has also requested input from 

local laboratory and public health representatives on the selection criteria used to 

inform the evaluation of laboratory instrumentation to ensure end-user needs are 

being met. The contact information of the BioWatch Program and Deputy Program 

Manager are well-advertised, and all members of BioWatch operations at all levels 

of government have been encouraged to call and discuss their needs and concerns 

directly with Program leadership. 

Question 4. A 2008 National Center for Risk and Economic Analysis of Terrorism 

Events report estimated the impact of a bioterror attack on a major league sports 

stadium would cost between $62 and $73 billion. In light of this estimate and the 
57 

Gen–3 cancellation, how does the Department plan to address this threat? Has the 

Post-Implementation Plan been completed? If not, what is the time line for its completion? 

Answer. OHA concurs with the severity of the estimate offered by CREATE. Further, BioWatch has consulted independent research within the scientific community 

that validates the significance and severity of such an event. 

The operational BioWatch system will continue its normal operations as a fundamental part of the Nation’s biodefense. Moving forward, OHA and S&T are working 

closely on development of a systems approach to next-generation biodetection including joint development of requirements. The systems approach will also look carefully 

at the results of an evaluation, completed by the BioWatch program earlier this 

year, of the existing operational BioWatch system. As the path forward is finalized, 

a full range of potential investments will be under consideration from near-term incremental improvements to longer-term shifts to a distributed, networked, sensoragnostic biosurveillance architecture with potential for capability beyond what the 

Department initially envisioned for Gen–3. 

The Post-Implementation Review along with its accompanying briefing is currently under DHS review. 

QUESTIONS FROM CHAIRWOMAN SUSAN W. BROOKS FOR KATHRYN BRINSFIELD

Question 1. Dr. Polk testified before this subcommittee in April 2012 that OHA 

and the CDC were in the process of developing a pilot program for the voluntary, 

pre-event vaccination of first responders. However, more than 2 years later, little 

progress has been made. 

What is the status of this important pilot program to protect our protectors? 

Answer. The Department of Homeland Security (DHS), in coordination with the 

Centers for Disease Control and Prevention (CDC), is developing the Anthrax preparedness and Protection Pilot to provide responders with a voluntary and comprehensive approach for preparing and protecting themselves consistent with broader anthrax preparedness guidance. Enhancing the ability of our Nation’s responders 

to conduct life-saving activities more safely and efficiently is a goal of this Department, as responders face a number of real and potential threats, including anthrax. 

DHS’s Office of Health Affairs (OHA) has been assessing the demand for and acceptance of pre-event anthrax vaccination for responders through a proposed Anthrax Preparedness and Protection Pilot. The goal of such a pilot is to assess the 

demand by responders and communities for the anthrax vaccine and the capability 

of Federal, State, local, Tribal, and territorial governments and organizations to deliver this program with the ultimate goal of better protecting responders and communities. 

Past biodefense vaccine efforts, such as the 2003 effort to encourage vaccination 

of health care workers and first responders against smallpox, encountered challenges in meeting the needs of the response community. Actively engaging the responder and public health communities will be the backbone on which this effort 

will be built. OHA has conducted outreach activities with 243 individuals representing public health, occupational health, emergency management, and responder communities and has increased awareness among many more stakeholders. 

Through this effort, stakeholders have expressed concerns such as their need to 

have increased awareness of the threat, education about comprehensive personal 

health protection, vaccine safety, liability protection, logistical implementation, and 

a strategic plan to protect unvaccinated families and communities. DHS and the 

CDC have redefined core program elements which are responsive to stakeholder requirements and are critical as we consider actions to the design and build-out pilot 

promotion and coordination of this effort. OHA is actively conferring with partners 

both inside and outside of the Department to capitalize on existing programs to implement this pilot. As pilot elements are developed, DHS will solicit community applications for two States to participate in the pilot through the Federal Register, 

making the process both open and transparent process. Successful applicants will 

be well-positioned to deliver a safe and quality program through demonstration of 

a qualified occupational health and safety program, accessible education platforms 

and the necessary infrastructure to handle the complete chain of receipt through delivery and monitoring of recipients of the vaccine. 

Question 2. In addition to reducing detection time, one of the goals of Gen–3 was 

to increase indoor detection. With the cancellation of Gen–3, what is the plan now 

for indoor detection? 

Answer. The technology currently used in BioWatch is employed indoors in limited locations; however its use requires multiple sampling events that increase costs 

to the Program. OHA, in cooperation with S&T, is examining a number of alter-
58 

native approaches to improve indoor detection including, but not limited to, the use 

of air monitoring systems that continuously sample indoor air spaces for irregularities (unusually high particle counts, fluorescence signatures, etc.) and provide a 

warning within minutes of a suspicious aerosol event to trigger and direct response, 

upgrading collectors using a collection medium that is able to preserve the viability 

of the collected organisms (e.g., liquid-based), and portable identification technology 

that allows for the rapid field identification of potential agents. Through S&T, DHS 

is also investigating alternative architectures for networked systems of sensors 

equipped with analytic capability for rapid determination of unusual and potentially 

hazardous biological and chemical contamination in the air, both for indoor and outdoor environments. 

Question 3. The value and effectiveness of BioWatch early detection is premised 

on the capability of State and local public health authorities to respond, for example, by directing the mass dispensing of medications or establishing mass treatment 

centers. Without the capability to respond with an appropriate public health and 

medical measures to minimize illness and death, the BioWatch warning will not 

produce a benefit. 

Please discuss what actions DHS takes (in partnership with the appropriate Federal, State, and local authorities) to ensure that sufficient medical countermeasures 

are in place to respond to an attack with any of the agents Gen–2 is designed. 

Answer. The BioWatch program not only provides the critical first laboratory detection of an aerosolized threat, it also supports the infrastructure that coordinates 

the initial awareness for response officials, including within the medical and public 

health community, that will initiate protective actions such as dispensing medical 

countermeasures (MCMs). The BioWatch Exercise Program provides BioWatch jurisdictions up to 7 exercises per year to improve local, State, and Federal preparedness 

for a large-scale bioterrorism attack. These exercises are tailored to each jurisdiction’s needs, are multi-disciplinary in nature, provide specific subject-matter expertise as needed, and are tightly focused on the initial BioWatch Actionable Result 

(BAR) assessment phase. In each jurisdiction, the BioWatch program has formalized 

partnerships with local and State agencies that include public health officials, emergency management, first responders, law enforcement, and laboratory officials. 

These local and State officials have designated points of contact at Federal agencies 

to aid in coordination. 

The Department of Health and Human Services (HHS) manages the Strategic National Stockpile (SNS) of MCMs as well as the Cities Readiness Initiative (CRI). 

Through CRI, State and large metropolitan public health departments have developed plans to respond to a large-scale bioterrorist event by dispensing antibiotics 

to the entire population of an identified metropolitan statistical area within 48 

hours. Further, Executive Order (EO) 13527 (December 20, 2009), ‘‘Establishing 

Federal Capability for the Timely Provision of Medical Countermeasures Following 

a Biological Attack,’’ Section 3, explicitly calls for the Secretaries of Homeland Security, Health and Human Services, and Defense, along with the Attorney General, 

to develop a Federal capability to immediately supplement the capabilities of affected jurisdictions to rapidly distribute MCM following a biological attack. On September 9, 2010, the Secretaries of the Departments of Homeland Security (DHS) 

and Health and Human Services (HHS), endorsed and forwarded to the White 

House National Security Staff, The Federal Interagency Concept of Operational 

Plan-Rapid Medical Countermeasures Dispensing (FICOP–MCM). The FICOP–MCM 

delineates options for the rapid and coordinated deployment of Federal resources to 

supplement State and local governments’ abilities to dispense MCM. This Federal 

capability resource is intended to be an initial rapid response to stabilize the situation in partnership with State and local authorities. 

FEMA is supporting this regional MCM planning initiative in concert with local 

CRI planning supported by the Centers for Disease Control and Prevention (CDC). 

This joint effort includes HHS regional representation; the CDC SNS senior official; 

as well as appropriate State, county, and city public health and emergency management officials. This initiative will result in a Regional MCM support annex to the 

Regions’ All Hazards Plan that is consistent with the scope, mission essential tasks, 

and concept of operations outlined in the FICOP–MCM. Each Regional MCM annex 

will, in turn, describe the Federal supporting concept of operations to support and 

complement the local CRI plan of the metropolitan area. 

Efficient delivery of medical countermeasures requires that critical decisions affecting how MCMs are dispensed be determined before we face such an incident. Towards this goal, DHS has worked with Federal partners, to include CDC, on guidance documents such as prioritization for anthrax vaccine in affected communities 

that addresses the need of those most at risk as well as the response community 

that we will rely on in such an incident. To further enable a rapid response, DHS 
59 

and its partners issued ‘‘Guidance for Protecting Responders’ Health During the 

First Week Following A Wide-Area Aerosol Anthrax Attack.’’ 

QUESTIONS FROM CHAIRWOMAN SUSAN W. BROOKS FOR CHRIS CUMMISKEY

Question 1. Setting requirements for large-scale acquisitions has been a challenge 

for the Department since its inception. 

What are you doing to work with program offices to ensure that well-developed 

requirements are put in place prior to the start of an acquisition? 

Answer. One of the principal focus areas of Secretary Johnson’s Unity of Effort 

initiative, as outlined in his April 22, 2014, memorandum entitled, ‘‘Strengthening 

Departmental Unity of Effort’’ is to continue to refine our acquisition oversight 

framework, especially in the earliest stages where acquisition requirements are developed. As part of this initiative, a component-composed and component-chaired 

Joint Requirements Council (JRC) has been established to review cross-component 

requirements and develop recommendations for investment, as well as changes to 

training, organization, and operational processes and procedures. The Department 

continues to enhance its acquisition governance and oversight structures to support 

and oversee programs after requirements are reviewed and approved by the JRC 

and DHS leadership. Additionally, the Department, working with its components, 

has in recent years established robust training and certification programs at the 

Homeland Security Acquisition Institute for program managers, systems engineers, 

cost estimators, and contracting specialists. Combined, these efforts will enable components to thoroughly develop organizational requirements on which acquisitions 

programs may be established. 

Question 2. DHS reported to Congress that the original life-cycle cost estimate for 

the 2009 decision—a point estimate unadjusted for risk—was $2.1 billion. Two years 

later, in 2011, DHS estimated that Gen–3 was expected to cost $5.8 billion (80 percent confidence) from fiscal year 2012 through June 2028. 

What specific steps does DHS plan to take to control costs and provide accurate 

reports to Congress that accurately describe the life-cycle costs of any follow-on systems or upgrades to Gen–2? 

Answer. Over the past 5 years, we have improved acquisition oversight, ensuring 

full consideration of the investment life cycle in cost estimates. Before any followon systems or upgrades to Gen–2, the current operationally-deployed system, are approved to proceed, they must get Acquisition Review Board approval, which includes 

full review and approval of planned life-cycle costs. 

As the Department’s Science and Technology Directorate, in partnership with 

OHA, explores the capability gaps and the capability needs of automated aerosol 

biodetection capabilities, any proposed follow-on systems or upgrades to Gen–2 will 

be under the management practices of the Department’s acquisition oversight policy, 

Management Directive 102–01. This management process controls the cost of acquisition programs in two ways. First, programs are required to develop accurate, credible, comprehensive, and well-documented Life-Cycle Cost Estimates at major acquisition decision event milestones to ensure that the costs are accurate for the life 

cycle of the program. Second, any future follow-on systems or upgrades to BioWatch 

Gen–2 are required by the DHS Chief Financial Officer to have met affordability 

requirements before proceeding through acquisition phases. 

Question 3. Will DHS continue to use the 80 percent confidence factor to ensure 

Congress has more reliable cost estimates in the future? 

Answer. While DHS policy requires acquisition programs be resourced to at least 

a 50% confidence level of the cost estimate, estimates are conducted at each confidence interval, and the ARB then discusses the appropriate estimate to use for 

budgeting based on the investment and program risk. 

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