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46–259 PDF 2009

ONE YEAR LATER—IMPLEMENTING THE BIOSURVEILLANCE REQUIREMENTS OF THE 9/11 

ACT 

HEARING 

BEFORE THE

SUBCOMMITTEE ON EMERGING 

THREATS, CYBERSECURITY, 

AND SCIENCE AND TECHNOLOGY 

OF THE

COMMITTEE ON HOMELAND SECURITY 

HOUSE OF REPRESENTATIVES 

ONE HUNDRED TENTH CONGRESS 

SECOND SESSION 

JULY 16, 2008 

Serial No. 110–128 

Printed for the use of the Committee on Homeland Security 

Available via the World Wide Web: http://www.gpoaccess.gov/congress/index.html 
COMMITTEE ON HOMELAND SECURITY 

BENNIE G. THOMPSON, Mississippi, Chairman 

LORETTA SANCHEZ, California 

EDWARD J. MARKEY, Massachusetts 

NORMAN D. DICKS, Washington 

JANE HARMAN, California 

PETER A. DEFAZIO, Oregon 

NITA M. LOWEY, New York 

ELEANOR HOLMES NORTON, District of 

Columbia 

ZOE LOFGREN, California 

SHEILA JACKSON LEE, Texas 

DONNA M. CHRISTENSEN, U.S. Virgin Islands 

BOB ETHERIDGE, North Carolina 

JAMES R. LANGEVIN, Rhode Island 

HENRY CUELLAR, Texas 

CHRISTOPHER P. CARNEY, Pennsylvania 

YVETTE D. CLARKE, New York 

AL GREEN, Texas 

ED PERLMUTTER, Colorado 

BILL PASCRELL, JR., New Jersey 

PETER T. KING, New York 

LAMAR SMITH, Texas 

CHRISTOPHER SHAYS, Connecticut 

MARK E. SOUDER, Indiana 

TOM DAVIS, Virginia 

DANIEL E. LUNGREN, California 

MIKE ROGERS, Alabama 

DAVID G. REICHERT, Washington 

MICHAEL T. MCCAUL, Texas 

CHARLES W. DENT, Pennsylvania 

GINNY BROWN-WAITE, Florida 

GUS M. BILIRAKIS, Florida 

DAVID DAVIS, Tennessee 

PAUL C. BROUN, Georgia 

CANDICE S. MILLER, Michigan 

I. LANIER LAVANT, Staff Director 

ROSALINE COHEN, Chief Counsel 

MICHAEL TWINCHEK, Chief Clerk 

ROBERT O’CONNOR, Minority Staff Director 

SUBCOMMITTEE ON EMERGING THREATS, CYBERSECURITY, AND 

SCIENCE AND TECHNOLOGY 

JAMES R. LANGEVIN, Rhode Island, Chairman 

ZOE LOFGREN, California 

DONNA M. CHRISTENSEN, U.S. Virgin Islands 

BOB ETHERIDGE, North Carolina 

AL GREEN, Texas 

BILL PASCRELL, JR., New Jersey 

BENNIE G. THOMPSON, Mississippi (Ex Officio) 

MICHAEL T. MCCAUL, Texas 

DANIEL E. LUNGREN, California 

GINNY BROWN-WAITE, Florida 

PAUL C. BROUN, Georgia 

PETER T. KING, New York (Ex Officio) 

JACOB OLCOTT, Director and Counsel 

DR. CHRIS BECK, Senior Advisor for Science and Technology 

CARLA ZAMUDIO-DOLAN, Clerk 

KEVIN GRONBERG, Minority Professional Staff Member 

(II) 
(III) 

C O N T E N T S 

Page 

STATEMENTS

The Honorable James R. Langevin, a Representative in Congress From the 

State of Rhode Island, and Chairman, Subcommittee on Emerging Threats, 

Cybersecurity, and Science and Technology ...................................................... 1 

The Honorable Michael T. McCaul, a Representative in Congress From the 

State of Texas, and Ranking Member, Subcommittee on Emerging Threats, 

Cybersecurity, and Science and Technology ...................................................... 2 

WITNESSES

PANEL I 

Mr. Robert Hooks, Deputy Assistant Secretary for WMD and BioDefense, 

Office of Health Affairs, Department of Homeland Security: 

Oral Statement ..................................................................................................... 4 

Prepared Statement ............................................................................................. 6 

Mr. Eric Myers, Director, National Biosurveillance Integration Center, Office 

of Health Affairs, Department of Homeland Security: 

Prepared Statement ............................................................................................. 6 

Mr. William O. Jenkins, Jr., Director, Homeland Security and Justice Issues, 

Government Accountability Office: 

Oral Statement ..................................................................................................... 11 

Prepared Statement ............................................................................................. 12 

Dr. James M. Wilson, V, Chief Technical Officer and Chief Scientist, Veratect 

Corporation: 

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

Prepared Statement ............................................................................................. 20 

PANEL II 

Mr. Robert Hooks, Deputy Assistant Secretary for WMD and BioDefense, 

Office of Health Affairs, Department of Homeland Security: 

Oral Statement ..................................................................................................... 41 

Prepared Statement ............................................................................................. 6 

Dr. Jeffrey Stiefel, Director, BioWatch, Office of Health Affairs, Department 

of Homeland Security: 

Prepared Statement ............................................................................................. 6 

Mr. William O. Jenkins, Jr., Director, Homeland Security and Justice Issues, 

Government Accountability Office: 

Oral Statement ..................................................................................................... 43 

Prepared Statement ............................................................................................. 12 

Dr. Frances Pouch Downes, State Public Health Laboratory Director, Department of Community Health, State of Michigan: 

Oral Statement ..................................................................................................... 44 

Prepared Statement ............................................................................................. 46 

FOR THE RECORD

Dr. David Hartley, Georgetown University Medical Center: 

Statement ............................................................................................................. 28 

(1) 

ONE YEAR LATER, IMPLEMENTING THE BIOSURVEILLANCE REQUIREMENTS OF THE 

9/11 ACT 

Wednesday, July 16, 2008 

U.S. HOUSE OF REPRESENTATIVES, 

COMMITTEE ON HOMELAND SECURITY, 

SUBCOMMITTEE ON EMERGING THREATS, CYBERSECURITY, AND

SCIENCE AND TECHNOLOGY, 

Washington, DC. 

The subcommittee met, pursuant to notice, at 2:19 p.m., in Room 

311, Cannon House Office Building, Hon. James R. Langevin 

[Chairman of the subcommittee], presiding. 

Present: Representatives Langevin, Christensen, Pascrell, and 

McCaul. 

Mr. LANGEVIN. The subcommittee will come to order. 

The subcommittee is meeting today to receive testimony on the 

current state and future course of the National Biosurveillance Integration Center, NBIC, and Project BioWatch. 

Before I begin my opening statement, I wanted to mention to the 

witnesses that there is a committee rule that testimony is supposed 

to be in 48 hours in advance. We got the DHS testimony this morning. We can’t do business like that, and I will caution you about 

ever doing it again. I don’t want to have the testimony received by 

this subcommittee that late ever again. It is unacceptable. We just 

can’t do business that way. 

With that, good afternoon. I would like to thank my colleagues 

for their participation, and I welcome our witnesses here today. 

As this committee is well aware, the threat of biological attack 

is real and potentially catastrophic. As the Chairman of the subcommittee, I have made it a priority to address the most glaring 

vulnerabilities facing our Nation, and this is certainly one of them. 

Of equal or greater concern, of course, is the possibility that a naturally occurring disease outbreak could grow to epidemic proportions. We have held numerous hearings on how better to protect 

against biological attack, and today we are continuing those efforts. 

Today, our focus will be on determining whether the biosurveillance requirements included in the Implementing Recommendations of the 9/11 Act of 2007, which became law on August 3, 2007, 

have been properly implemented. The 9/11 Act included two key 

sections regarding our Nation’s biosurveillance capabilities. Section 

1101 authorized the National Biosurveillance Integration Center, 

or NBIC, and section 1102 requires the Government Accountability 

Office, GAO, to submit a report to Congress describing all Federal, 
2 

State, and local biosurveillance efforts. Each of these will help protect against biological threats, whether man-made or natural. 

The key to stopping an outbreak from becoming an epidemic or 

an attack from becoming a catastrophe is early detection, identification, tracking, and response. 

Now, the National Biosurveillance Integration Center, NBIC, and 

the BioWatch program, housed in the Department of Homeland Security, are critical to this mission. Each of these programs are designed to provide early detection of disease outbreaks, a critical 

role in preventing or containing their spread. The NBIC was created to fulfill the requirements of Homeland Security Presidential 

Directive 9, ‘‘Defense of U.S. Food and Agriculture,’’ issued in January 2004, or better known as HSPD–9. 

NBIC’s mission is to develop robust, comprehensive, and fully coordinated surveillance and monitoring systems, including international information for animal disease, plant disease, wildlife disease, food, public health, and water quality that provides early detection and awareness of disease, pests, or poison agents. Section 

1101 of the 9/11 Act authorized the NBIC and set a deadline of 

September 30, 2008, for full operation. 

I am concerned that, although progress has been made, most estimates are that we are still 2 years away from having the full participation of Federal, State, local, tribal, private sector, and international partners that a robust biosurveillance capability requires. 

I am hopeful that our witnesses can shed some light on the current 

obstacles to getting the NBIC operational. 

I also look forward to hearing, of course, from our witnesses on 

the status of the BioWatch program, which consists of two components, research and development activities on the next generation 

biodetectors, which are run by the DHS Science and Technology Directorate, while acquisition, operations, and management are now 

handled by the Office of Health Affairs. 

Today, we will focus on the current state of both NBIC and 

BioWatch. While I am concerned that each of these programs has 

lingering problems, I am hopeful that this hearing will help provide 

a course to overcome current obstacles and move these programs 

forward. 

With that, I do thank our witnesses for being here today. 

The Chair now recognizes the Ranking Member of the subcommittee, my partner in these efforts, the gentleman from Texas, 

Mr. McCaul, for an opening statement. 

Mr. MCCAUL. Let me thank the Chairman for holding this important hearing on the Nation’s biosurveillance capabilities. 

In May 2006, the subcommittee held a hearing on the Department of Homeland Security’s development of the Nation’s biosurveillance architecture. Now, 2 years later and a year after the 

passage of the 9/11 Act, this hearing presents the opportunity to 

once again assess the strength of our Nation’s surveillance capabilities. 

Detecting a bioterror attack or a naturally emergent disease is 

a critical first step to mounting an effective response. The sooner 

we detect an agent in the environment or in people, the better 

chance we have of mitigating its harmful consequences. 
3 

The National Biosurveillance Integration Center and BioWatch 

are two key elements to this enterprise. No one system has ever 

attempted to integrate all the streams of biosurveillance data collected by Federal, State, local, and private entities. The NBIC is an 

ambitious but a critical plan to create a one-stop shop for human, 

animal, and plant biosurveillance information. 

The legislative origins of the NBIC can be found in the committee’s 2006 authorization bill. Without question, the NBIC has its 

challenges, from technical hitches to interagency hurdles, but it has 

worked through many of these to become a more effective operating 

center. Most recently, it lent its expertise to provide surveillance 

data for the Nation-wide salmonella outbreak. I look forward to 

learning from our witnesses just how far along the Center has 

come. 

I also take great interest in the Department’s plan for BioWatch. 

This detection program provides an environmental monitoring system to cities around the Nation for early detection of airborne biological threat agents. Having been required to beef up their preparedness and response plans, many of those jurisdictions with 

sensors are now better prepared for a bio-event. DHS has lead the 

way in creating groundbreaking Federal planning guidance for 

dealing with intentional release of a bioterrorism agent, and 

BioWatch has helped bring Federal, State, and local governments 

together for a common purpose. We await the next generation of 

sensors, the new technology, with a particular interest in whether 

plans for a fully automated indoor system are truly viable in the 

near future. We cannot, however, expect the Office of Health Affairs to effectively complete this work if its requested fiscal year 

2009 budget is cut by $27 million, as the House Appropriations 

Committee would have it. 

In today’s Washington Post, there was commentary on the hearing, this hearing and one in the Senate, regarding DNDO and also 

BioWatch. With respect to BioWatch, which is the focus of this 

hearing, they said in the Washington Post that: A 5-year-old program to detect the airborne release of biological warfare agents, 

such as anthrax, plague, and smallpox, in more than 30 major U.S. 

cities still lacks basic technical data to help medical officials determine how to respond to an alert triggered by the sensors. Congressional investigators and State and local officials will report to the 

House Homeland Security Committee. 

I look forward to hearing from the four of you on this issue specifically, and how we can better integrate. We have our deadline 

coming up, as I understand, September. Can we reach that deadline? What technology is in the future to make this a better system? 

With that, I yield back. 

Thank you. 

Mr. LANGEVIN. I thank the gentleman. Other Members of the 

subcommittee are reminded that, under the committee rules, opening statements may be submitted for the record. 

I now want to welcome our first panel of witnesses. 

Our first witness, Robert Hooks, serves as the Deputy Assistant 

Secretary for WMD and BioDefense in the Office of Health Affairs 

of the Department of Homeland Security. He is responsible for the 
4 

Department’s early detection biodefense programs, including the 

National Biosurveillance Integration Center and BioWatch, two 

Homeland Security programs that address animal security, food defense, and biological threat mitigation efforts. 

Our second witness, Eric Myers, is the director of the National 

Biosurveillance Integration Center, NBIC, starting in January 

2008. His previous assignment was deputy director of NBIC, starting in September 2006. 

Our third witness is William Jenkins, director of Homeland Security and Justice Issues at the Government Accountability Office. 

The GAO is conducting a study of national biosurveillance efforts 

pursuant to section 1102 of the 9/11 Act. Although the study is not 

yet complete, GAO has agreed to discuss their initial findings relevant to this hearing, and we do appreciate that. 

Our fourth witness on this panel is James Wilson, chief executive 

officer and chief scientist of the Veratect Corporation. Prior to that, 

he was principal investigator at Project Argus and a member of the 

Department of Homeland Security’s National Biosurveillance Integration System, NBIS, concept design review team, and the first 

chief of analytic operations at the National Biosurveillance Integration Center. 

With that, and without objection, the witnesses’ full statements 

will be inserted into the record. 

I want to welcome each of you here today, and I now ask each 

witness to summarize their statement for 5 minutes, beginning 

with Mr. Hooks, who will read a joint statement from himself and 

Mr. Myers. 

Welcome. 

STATEMENT OF ROBERT HOOKS, DEPUTY ASSISTANT SECRETARY FOR WMD AND BIODEFENSE, OFFICE OF HEALTH 

AFFAIRS, DEPARTMENT OF HOMELAND SECURITY, ACCOMPANIED BY ERIC MYERS, DIRECTOR, NATIONAL BIOSURVEILLANCE INTEGRATION CENTER, OFFICE OF HEALTH 

AFFAIRS, DEPARTMENT OF HOMELAND SECURITY 

Mr. HOOKS. Thank you, Mr. Chairman. 

I have heard your words. I apologize that our testimony was in 

late, and I apologize sincerely for that. 

Mr. Chairman, Ranking Member McCaul, and Members of the 

subcommittee, thank you for the opportunity to testify today on the 

Department of Homeland Security’s biosurveillance efforts. 

I serve as the Deputy Assistant Secretary for WMD and BioDefense, a division within the Office of Health Affairs. 

Also with me is Eric Myers, the director, as you mentioned, of 

NBIC. 

I appreciate your interest in this biosurveillance program and 

trust that my testimony today will provide valuable insight into the 

Department’s biosurveillance initiatives to safeguard the Nation 

against a biological attack or other biological incidents that threaten the security of the homeland. 

The Nation continues to face the risk of a major biological event 

that could cause catastrophic loss of human life, severe economic 

damages, and significant harm to our Nation’s critical infrastructures and key resources. The challenges we face in assessing cur-
5 

rent terrorist capabilities and identifying plots make it unlikely 

that we will receive actionable specific warning of an impending 

bioterrorist attack. 

Furthermore, many of these deadly biologic agents are accessible 

in nature, relatively easy to procure, and can be developed and 

transported without an advanced background in the biological 

sciences. Unlike nuclear weapons, only a few people with advanced 

laboratory knowledge in the biological sciences are needed to 

weaponize many of these deadly pathogens. As such, it is incredibly 

difficult to predict and prevent a biological attack from taking 

place. 

Having an early warning system capability against a biological 

threat is critical to reduce the potential loss of human life and prevent severe economic damages and other associated consequences. 

Our first indication of a bioterrorist attack will likely be through 

an early detection and warning system, such as BioWatch and the 

NBIC. I will discuss BioWatch further during the next panel. In 

the event that a bioterrorism event occurs in the homeland, a comprehensive biosurveillance capability can minimize the impact and 

duration of the event via early detection and characterization, 

broad situational awareness, and by facilitating early intervention 

and mitigation. 

Secretary Chertoff, in collaboration with other appropriate Federal departments and agencies, established a platform for information exchange between senior leaders and Federal partners to facilitate the early recognition of biologic events, including natural 

disease outbreaks, accidental or intentional use of biological agents, 

and emergent biohazards. This platform is known as the National 

Biosurveillance Integration System, NBIS. 

NBIC, the Center located at DHS headquarters, seeks to provide 

information to interagency partners via the NBIS platform to allow 

early recognition of biological events of national concern, both natural and manmade, in order to make timely response possible. Currently, 12 Federal agencies exchange information on the NBIS platform. Eventually, this platform of information exchange will evolve 

to include State, local, and tribal entities, and potentially the private sector and international stakeholders as well. 

We have established the NBIS Interagency Working Group, 

NIWG, which meets monthly to provide an open forum among Federal partners to enhance such information exchange. NBIC has developed a governance structure to provide senior level oversight of 

operations to ensure that the interagency goals and objectives are 

met. NBIC personnel analyze and monitor over 530 information 

feeds. During these information feeds, NBIC develops and shares 

the biological common operating picture, we refer to it as BCOP, 

with the NBIS interagency partners. The BCOP provides a comprehensive assessment of current biological events, data, and 

trends, and their potential impacts on the Nation’s security. 

In conclusion, developing an interagency biosurveillance capability focusing on biological threats in human health, animal, plant, 

food, and water is very difficult and a complicated task that has 

not been previously attempted. The challenge of detecting an impending bioterrorist plot and preventing an attack or an emergent 

of a naturally occurring pandemic outbreak is daunting. That is 
6 

why Homeland Security is enhancing early detection warning systems to build a comprehensive national biosurveillance capability 

to prevent a biological threat from becoming a catastrophic event. 

Thank you for the opportunity to testify. 

[The joint statement of Mr. Hooks, Mr. Myers and Dr. Stiefel follow:] 

JOINT PREPARED STATEMENT OF ROBERT HOOKS, ERIC MYERS, AND JEFFREY STIEFEL

JULY 16, 2008 

INTRODUCTION

Mr. Chairman, Ranking Member McCaul, and Members of the subcommittee, 

thank you for the opportunity to testify today on the Department of Homeland Security’s (DHS) biosurveillance efforts. I serve as the Deputy Assistant Secretary for 

WMD and Biodefense, a division within the Department of Homeland Security’s Office of Health Affairs (OHA). I appreciate your interest in our biosurveillance programs, and trust that my testimony today will provide valuable insight into the Department’s biosurveillance initiatives to safeguard the Nation against a biological 

attack or other biological incidents that threaten the security of the homeland. 

The Nation continues to face the risk of a major biological event that could cause 

catastrophic loss of human life, severe economic damages, and significant harm to 

our Nation’s critical infrastructures and key resources. As you so vividly remember 

the Nation already experienced a form of bioterrorism in late 2001 with the deadly 

anthrax mailings that cost the lives of 5 individuals, injured 17, and caused severe 

disruptions to many of our Government activities, including operations of the U.S. 

Postal Service and numerous other functions. 

The challenges we face in assessing current terrorist capabilities and identifying 

plots make it unlikely that we will receive actionable, specific warning of an impending bioterrorist attack. Furthermore, many of these deadly biological agents are 

accessible in nature, relatively easy to procure, develop and transport without an 

advanced background in the biological sciences. Unlike nuclear weapons, few people 

with advanced laboratory knowledge in the biological sciences are needed to 

weaponize many of these deadly pathogens. As such, it is incredibly difficult to predict and prevent a biological attack from taking place. The threat of bioterrorism 

has not subsided, and the impact of a large-scale bioterrorism event, such as the 

wide-spread dissemination of an aerosolized form of anthrax or other deadly biological pathogen, would have a serious effect on the health and security of the Nation. 

A bioterrorist plot may not have detectable signals, thus, there may be little or 

no warning of an impending biological attack, presenting significant challenges to 

the identification, detection, and disruption of such plots. Our first indication of a 

bioterrorist attack will likely be through early detection and warning systems, such 

as BioWatch and the National Biosurveillance Integration Center (NBIC). Their detection capabilities will drive the subsequent response and significantly influence 

the number of individuals affected by an attack. 

In the event that a threat does reach, or occur in, the homeland, a comprehensive 

biosurveillance capability can minimize the impact and duration of the event via 

early detection and characterization, broad situational awareness and by facilitating 

early intervention and mitigation. 

BIOSURVEILLANCE

An integrated biosurveillance program is vital to help protect the homeland from 

bioterrorism: unintentional introductions (e.g. Foot-and-Mouth Disease); and naturally occurring biological events, such as pandemic influenza. Biosurveillance refers 

to monitoring for potential signs of biological events with the intent of early detection of that event to permit the timely response to mitigate consequences. Should 

an event occur, biosurveillance and detection allows the monitoring of an outbreak 

as it happens and provides accurate situational awareness to first responders. Biosurveillance is one of the critical components of our Nation’s biodefense strategy, as 

outlined in Homeland Security Presidential Directive (HSPD) 10: Biodefense for the 

21st Century. 

Biosurveillance includes many different components that work in complementary 

fashion to achieve a comprehensive awareness. This takes the form of both traditional and novel methods of early event detection including environmental detection 

systems, clinical syndromic surveillance, reportable disease and laboratory-based 

surveillance, monitoring of agricultural and wildlife activity, testing of the food sup-
7 

ply, and monitoring mail and open-source analysis to name a few. Each is a necessary and valuable component of a comprehensive biosurveillance strategy. I would 

like to discuss two biosurveillance programs that the Department is leading as part 

of the Federal Government’s larger biosurveillance strategy: NBIC and the Biowatch 

Early Detection System. 

NATIONAL BIOSURVEILLANCE INTEGRATION CENTER (NBIC)

Recognizing the need to create a new biological threat surveillance capability 

across multiple sectors and domains to provide early awareness and warning of 

emerging biological events, Secretary Chertoff, in collaboration with the other appropriate Federal Departments and agencies, established the National Biosurveillance Integration System (NBIS), which serves as the platform for information exchange between senior leaders and partners agencies and facilitates the early recognition of biological events, including natural disease outbreaks, accidental or intentional use of biological agents, and emergent biohazards. 

Currently, twelve Federal Member Agencies comprise the NBIS community. Eventually, this community will evolve to include State, local and tribal entities, and potentially the private sector and, international stakeholders. The NBIS community 

provides situational awareness through the acquisition, integration, analysis and 

dissemination of information from existing human disease, food, agriculture, water, 

meteorological, and environmental surveillance systems and relevant threat and intelligence information. 

In 2007, Congress passed and President Bush signed Pub. L. 110–53, The Implementing of the 9/11 Commission Recommendations Act of 2007 which formally authorized the establishment of the National Biosurveillance Integration Center 

(NBIC), which serves as the hub of operations and personnel to which the NBIS 

community contributes information. The NBIC is located in the DHS Nebraska Avenue Center and is charged with the primary mission to rapidly identify, characterize, localize, and track a biological event of national concern; integrate and analyze data relating to human health, animal, plant, food, water; and disseminate 

alerts and pertinent information. NBIC seeks to provide information to allow early 

recognition of biological events of national concern, both natural and man-made, in 

order to make a timely response possible. No other entity in Government serves to 

integrate this biological threat information from across the spectrum of public and 

private, domestic and international, open or protected sources. 

As an operating center, the vital component parts of NBIC are: 

• A corps of highly trained subject matter experts (SMEs) and analysts, including 

a 24-hour/7-day OHA Watch Desk within the DHS National Operations Center; 

• Tailored customer products resulting from integrative analysis of biosurveillance information; 

• A culture of cooperation, trust and mutual support across the Federal Government and other partners; and 

• A robust information management system capable of handling large quantities 

of structured and unstructured information. 

DEVELOPING AN INTERAGENCY INFORMATION SHARING CAPABILITY

Developing interagency cross-domain biosurveillance capability is a difficult and 

complicated task that has not been previously attempted. Coordination with our 

Federal partners to obtain data, personnel, and information-sharing agreements requires new processes and procedures. Additionally, building a new IT system to coordinate the information sharing, as well as creating new analytical tools to assist 

analysts in identifying trends, patterns, and anomalies quickly and accurately as is 

necessary for forward-looking and cueing capability has taken time. However, we 

are still scheduled to meet our full operational capability (FOC) goals by September 

30, 2008. 

NBIC has formalized its relationship with a number of Federal partners, and continues to make progress on obtaining formal agreements with the remaining relevant Federal Agencies in order to promote a robust interagency biosurveillance capability. MOUs are in place with Departments of Defense, State, Agriculture, Interior, Health and Human Services, and Transportation. We are also working closely 

with the Department of Veterans Affairs, FBI, Environmental Protection Agency, 

U.S. Postal Service, and the Department of Commerce and other components within 

DHS. While final details of some of these agreements are being resolved, these Departments and agencies are currently contributing to the NBIC mission and providing valuable information on current bio-events. 

NBIC has established the NBIS Interagency Working Group (NIWG) which meets 

monthly to provide an open forum among NBIS members to discuss interagency col-
8 

laboration, develop detailed operational procedures and offer recommendations to 

enhance the capability of NBIS. The NIWG representatives possess a detailed 

knowledge of their respective organization’s biosurveillance-relevant capabilities, 

programs and activities that can contribute to the integrated effort. This collaboration has produced the first version of the NBIS Concept of Operations which lays 

out the details of how the mission of NBIS is being implemented and executed. This 

document is significant in that it describes the steps NBIS will take to accomplish 

the unprecedented task of biosurveillance cross-domain integration and analysis. 

Further, NBIC has developed a governance structure to provide senior-level oversight of operations to ensure that interagency goals and objectives are met. The National Biosurveillance Integration System Interagency Oversight Council is made up 

of representatives at the assistant secretary level from each NBIS member agency 

and acts as the senior oversight body to provide guidance and direction for the efficient operation and evolution of NBIS. 

NBIC INFORMATION INTEGRATION AND ANALYSIS

To accomplish the biosurveillance mission, the NBIC monitors over 530 information feeds. Monitoring of these information feeds is facilitated by the NBIS 2.0 IT 

system. These sources include interagency communications and 165 open-source 

sites. These open-source sites include 20 organizational sites, 14 Federal Government sites, 85 State, local, or territorial government health and agriculture sites, 

35 foreign government sites, and 2 commercial sites. 

Using its information feeds, NBIS develops and shares a Biosurveillance Common 

Operating Picture (BCOP) with the NBIS community. The BCOP is a comprehensive electronic picture with assessments of current biological events, trends and 

their potential impacts on the Nation’s homeland security. The BCOP provides a secure platform for cross-domain information analysis by NBIS subject matter experts 

to learn more about and collectively evaluate current situations. An impact assessment of an event constitutes a major portion of the NBIS BCOP information dissemination. 

As an example of the NBIC capability, several NBIS member agencies continue 

to work closely together to provide comprehensive situational awareness to Federal 

agencies on the current Salmonella stereotype Saintpaul event. NBIC remains thoroughly engaged in the tracking of this event, and regularly posts Situational Reports (SITREPs) on the BCOP. Thus far, NBIS has released 11 national SITREPs 

on this event. 

NBIC FULL OPERATING CAPABILITY

NBIC has developed a set of goals to address the highest priority requirements 

to achieve FOC by September 30, 2008, which assumes the current reprogramming 

request before Congress. We continue to progress toward the following to achieve 

full operational capability: 

• Install interagency staff and enhanced space resources for NBIC; 

• Enhance IT Infrastructure for biosurveillance; 

• Expand the NBIS Interagency Community; 

• Further develop NBIC Intra-Agency Collaboration; 

• Continue NBIC Collaborative Analysis and Production; 

• Refine the NBIC Five-Year Strategic Plan with modified objectives; and 

• Refine the NBIC Contingency Operations Plans with updated strategies. 

BIOWATCH

I would also like to discuss the Department’s BioWatch Program, which was established in January 2003, and is currently managed by OHA. The BioWatch mission is to deploy and maintain a national 24/7 early warning system capable of detecting the intentional release of select aerosolized biological agents in order to 

speed response and recovery efforts. The purpose of this early detection and warning 

capability is to mitigate the consequences of a catastrophic attack, which could affect tens of thousands of people if, for example, aerosolized anthrax were released. 

The goals of the BioWatch Program include: 

• Early detection and characterization of biological attacks against the Nation’s 

cities, high value assets, and mass gatherings to allow for the rapid distribution 

of life-saving countermeasures; 

• Cost-effectively improving bio-aerosol threat monitoring capability and increasing its capacity to cover a greater portion of the general population; 

• Providing operational and consequence management guidance and assistance to 

Federal, State, local, and tribal entities; and 
9 

• Integrating BioWatch capabilities into a national bio-threat monitoring and response system. 

BioWatch is part of a national biodefense strategy that includes intelligence, law 

enforcement, bio-monitoring, situational awareness, decision support, response, and 

recovery activities. Within this strategy, BioWatch is an essential component of biomonitoring, along with astute clinicians, syndromic surveillance, food and agriculture monitoring, veterinary surveillance, and mailroom monitoring. BioWatch 

technical and operational capabilities are integrated with military capabilities at installations to the benefit of both the Department of Defense and DHS. 

Bio-monitoring of infectious agents will enable earlier treatment of affected populations than would otherwise be possible, and contribute to the prevention of secondary transmission, thereby reducing morbidity, mortality, and the associated 

health care costs from a biological terrorist attack. Each component of bio-monitoring relies on different technologies and techniques that are optimized for their 

intended purpose. It is through situational awareness and decision support that biomonitoring is linked with the public health and medical response communities that 

must respond in the event of a biological terrorist event. 

CURRENT BIOWATCH CAPABILITY

The current generation BioWatch system, which is operating in over 30 of the Nation’s largest metropolitan areas, is composed of aerosol collectors, secondary sampling kits, laboratories, guidance documents, concepts of operation, communications 

protocols, an internet-based information portal, subject matter experts, and a small 

number of early generation indoor detectors. System operation requires the integration and coordination of Federal, State, and local authorities whom all play an active role in the program. The system is tested routinely at each of the local jurisdictions where it is deployed. 

The BioWatch program has established and strengthened existing local infrastructure. Laboratory procedures and field operations have been standardized and are reviewed periodically for quality assurance by the BioWatch program. Detailed environmental sampling plans have been developed that could be used to gather information about the viability and distribution of a bio-agent detected by the system. 

BioWatch laboratories that analyze filters taken each day from the aerosol collectors are part of the Laboratory Response Network (LRN). Laboratory personnel follow strict protocols using laboratory assays that were developed jointly by the CDC 

and Lawrence Livermore National Laboratory to analyze the filters for the presence 

of biological threat agents. The BioWatch laboratories have been in continuous operation since 2003, having analyzed more than 7 million samples without a single laboratory false positive result. 

If BioWatch detects the presence of a bio-agent of concern, it issues a signal 

known as a BioWatch Actionable Result (or BAR). Since the Program’s inception, 

dozens of BARs have been reported by multiple BioWatch State and local jurisdictions. These valid laboratory findings have been attributed in all cases to naturally 

occurring environmental sources. 

BioWatch operational readiness is essential for the system to be effective. Readiness involves planning, preparedness, detection, and initial response. Representatives from these agencies, along with State and local public health and response personnel, have created guidance documents for local jurisdictions to use in developing 

operational plans for BioWatch. 

These guidance documents cover preparedness, response, environmental sampling, 

and indoor operations. They are reviewed and updated periodically by the Federal 

BioWatch Working Group to take advantage of lessons learned through training, exercises, and real-world execution of operational plans in response to positive laboratory results from environmental sources. 

The operational response plans for each jurisdiction are triggered by a BAR and 

implemented by a local BioWatch Advisory Committee (or BAC). A BAR triggers a 

formal notification process whereby the local public health official notifies local, 

State and Federal partners. The public health official convenes the BAC via conference call to begin situational assessment; Federal and State partners join BAC 

members in a national teleconference within 2 hours of notification. The initial call 

may be followed by others as more pertinent information becomes known. Investigation and discussions continue until consensus is reached about the significance of 

the BAR, which is used to inform protective action decisions on the part of the local 

public health official. 

Each environmental BAR has provided local, State, and Federal Government personnel an opportunity to exercise its preparedness plans and coordination activities 

that are fundamental to an effective response to a bioterrorism event or some other 
10 

incident of public health significance. These real world events have been a catalyst 

for collaboration among local, regional, State, and Federal authorities, resulting in 

greater integration of public health, medical, veterinary, laboratory, emergency response, and critical infrastructure personnel responsible for consequence management across the full spectrum of public health threats facing our Nation. 

BioWatch technical and operational capabilities are also integrated with related 

military capabilities at installations around the country to the benefit of both DHS 

and the Department of Defense. It is through situational awareness and decision 

support that bio-monitoring is linked with the public health and medical response 

communities that must respond in the event of a biological terrorist event. 

DEVELOPING FUTURE BIOWATCH CAPABILITY

The BioWatch system continues to evolve with new technologies, new partnerships with other bio-monitoring activities in the Government and private sector, and 

a refined national bio-monitoring architecture. We are striving to further the 

BioWatch system technologies and improve procedures to reduce the time-to-detect 

between biological agent release, detection and follow-on response. We are also 

working to increase the number of biological agents that are detected and to increase the population coverage in existing BioWatch jurisdictions, including in the 

highest risk indoor facilities. 

We are striving to improve the detection capabilities of the system, while ensuring 

that appropriate testing and evaluation control processes are in place. We are working with DHS’s Testing and Evaluation team on future technology developments to 

ensure the appropriate level of independent oversight to make informed decisions 

regarding deploying improved technologies and reducing risk of technological shortcomings. 

One of our high-priority initiatives is to replace collectors—the filters of which require formal laboratory analysis—with automated detectors, wherein the analysis is 

performed within the unit itself. The primary objective of the Generation 3 system 

is the development of automated detectors that will significantly reduce the time to 

detect a biological agent from the current 10 to 34 hours down to between 4 and 

6 hours which will potentially save thousands of lives for each day an attack, such 

as anthrax, is detected ahead of human syndromic surveillance and other public 

health indicators. 

The BioWatch operational requirements (e.g., logistics, readiness and interoperability) stem from OHA’s experience operating the system. Detailed requirements 

are captured in the Generation 3 Operational Requirements Document. That document is our guide for ensuring that the best automated detection system will be selected and fielded. The responsibilities for technical improvements and supporting 

R&D are jointly shared by DHS’s Science and Technology (S&T) Directorate and 

OHA. Technologies under consideration must meet operational requirements for performance, operability, and reliability. As with any upgrade to a complex system, it 

is not as simple as plugging in a new component and assuming that the technology 

will work well and integrate properly with all other material and non-material elements of the system. To ensure new technology deployments are successful, candidate detectors need to be thoroughly tested under real-world operational conditions. 

The operational test and evaluation of automated detectors under consideration 

for inclusion in the BioWatch Generation 3 system are scheduled to begin in April 

2009. The tests will be conducted in two BioWatch jurisdictions over a period of 3 

to 6 months. A procurement decision will then be made; the initial deployment of 

the BioWatch Generation 3 system is planned for fall 2010. The Generation 3 system will be operated along side Generation 2 systems for a period of 60 to 90 days 

to facilitate the transition to the enhanced system. 

BioWatch deployment strategies are derived from risk-based analyses that account for threat, vulnerability, and consequences. Our plan is to continue increasing 

the population coverage in existing BioWatch jurisdictions, as well as expand coverage to new locations or facilities when the risk is determined to be high enough 

to warrant 24/7 environmental monitoring. 

Given the current system’s lag time between an attack and detection, DHS believes it is necessary to procure and deploy an interim automated system which we 

call Generation 2.5 designed to reduce notification times to as little as 4 to 6 hours. 

This interim system will be deployed in high-consequence indoor environments to 

provide coverage of the highest risk facilities before the Generation 3 system will 

be ready for deployment. 

The BioWatch program will continue to reduce the risks associated with bioterrorism and continues to develop future technology options and best deployment op-
11 

tions. This will provide increased safety to the American public through early detection of biological pathogens that threaten our public health. 

CONCLUSION

Biological threats to the homeland continue to be of concern. We are facing persistent and evolving terrorist threats with potentially catastrophic consequences. A 

catastrophic biological event, such as a WMD terrorist attack, or a naturally occurring pandemic or emerging disease outbreak, could cause hundreds of thousands of 

casualties, damage our economy and the public’s confidence, and threaten the security of our homeland. As I stated earlier, the challenge of detecting an invisible footprint of an impending bioterrorist plot and preventing an attack or the emergence 

of a pandemic is daunting. That is why DHS is taking the approach of enhancing 

early detection systems and building a national biosurveillance capability for situational awareness—to prevent a biological event from becoming a Nation-changing 

catastrophic event. 

Our goal is to generate timely and comprehensive information about a biological 

event and put it into the hands of decisionmakers responsible for the continuity of 

society and Government. I have observed in today’s vernacular that ‘‘time zero’’ 

when a response can be initiated is often referred to as the time an event is known 

to have occurred, not when the event actually occurred. The time lag between the 

true ‘‘time zero’’ when an event occurs and when it is recognized is critical in determining how successful a response will be in mitigating loss of life and suffering. 

DHS is committed to improving the Nation’s biodetection and biosurveillance capabilities so that we can achieve a ‘‘time zero’’ as close to the true time of the actual 

event as possible. 

I appreciate the opportunity to share the vision, status and direction of the NBIC 

and BioWatch biosurveillance programs with you and look forward to your comments and guidance on how to better shape the programs to protect the American 

public against intentional and natural biological events. Thank you for the opportunity to testify. I would be happy to provide answers to any questions that you may 

have. 

Mr. LANGEVIN. I thank the witness. 

The Chair now recognizes Mr. Jenkins to summarize his statement for 5 minutes. 

Welcome. 

STATEMENT OF WILLIAM O. JENKINS, JR., DIRECTOR, HOMELAND SECURITY AND JUSTICE ISSUES, GOVERNMENT ACCOUNTABILITY OFFICE 

Mr. JENKINS. Thank you. Chairman Langevin, Ranking Member 

McCaul, and Members of the subcommittee. 

The 9/11 Commission Act mandated that GAO review biosurveillance efforts at the Federal, State, local, and tribal levels of Government. That review is ongoing. 

I am pleased to be here today to discuss our preliminary operations on DHS’s efforts to establish a fully operational National 

Biosurveillance Integration Center by the statutorily mandated 

September 30 deadline. DHS has not finalized the capabilities that 

the Center must have to be fully operational, nor has it clearly 

identified the capabilities it anticipates NBIC will have as of September 30 of this year. 

The former acting director of NBIC testified last October that 

NBIC has three vital components of success: One, a robust information management system capable of handling large quantities of 

structured and unstructured information. Two, a core of highly 

trained subject matter experts and analysts. Three, a culture of cooperation, trust, and mutual support across the Federal Government and other partners. 

DHS and NBIC leadership have taken steps in each of these 

areas, such as filling 26 of 37 authorized positions, hiring a perma-
12 

nent staff director, acquiring facilities for NBIC that can accommodate classified data, creating a 24-hour watch center, and reaching 

out to 11 other agencies that DHS has identified as having analytical resources and data useful to NBIC’s integration mission. 

The success in achieving the first two objectives, a robust information management system and a core of subject matter experts 

to analyze data, are dependent upon obtaining the cooperation and 

substantive participation of agencies with relevant data and expertise. DHS has reached out to these agencies but had limited success to date in completing three types of agreements with each 

agency: First, memorandums of understanding, in which the agencies agree to participate as a member of NBIC. Six of the 11 agencies have signed MOUs with NBIC, Department of Defense, Agriculture, Health and Human Services, State, Interior, and Transportation. Five agencies have not yet signed MOUs, the FBI, Veterans 

Administration, Postal Service, EPA, and the National Oceanic and 

Atmospheric Administration. 

Second, interagency agreements that describe the programmatic, 

financial, and staffing between NBIC and participating agencies. 

None of these agreements have yet been finalized. Only one agent, 

CDC, has provided a detailee to NBIC. 

Third, interagency security agreements that formalize the types 

of data that agencies will share with NBIC’s IT system and their 

access to that system. None of these agreements have been signed, 

either. 

It is important to note that DHS cannot compel the participation 

of these 11 agencies. As in many other areas in which DHS is trying to develop cross-agency programs, the principle challenge is 

getting the full cooperation of agencies that have not historically 

cooperated and worked together in a fully integrated manner. 

Finally, on April 1, 2008, a contractor delivered to NBIC an upgrade to its information technology system intended to enhance its 

data integration capabilities. However, DHS officials said that before this upgrade can be used effectively, NBIC will need to train 

its employees to use the system, training that it expects to complete in early 2009. In addition, NBIC will need to negotiate the 

previously mentioned interagency agreements to define the data 

participating agencies will provide for the system and their access 

to that system. It is not clear when that may be completed. 

That concludes my statement, Mr. Chairman. I would be pleased 

to respond to any question you or other Members of the subcommittee may have. 

[The statement of Mr. Jenkins follows:] 

PREPARED STATEMENT OF WILLIAM O. JENKINS, JR. 

JULY 16, 2008 

GAO HIGHLIGHTS

Highlights of GAO–08–960T, a testimony before the Subcommittee on Emerging 

Threats, Cybersecurity, and Science and Technology, Committee on Homeland Security, House of Representatives. 

Why GAO Did This Study 

The United States faces potentially dangerous biological threats that occur naturally or may be the result of a terrorist attack. The Department of Homeland Security (DHS) is developing two major initiatives to provide early detection and warn-
13 

ing of biological threats: The National Biosurveillance Integration Center (NBIC), a 

center for integrating and coordinating information on biological events of national 

significance, and the BioWatch program that operates systems used to test the air 

for biological agents. The Implementing Recommendations of the 9/11 Commission 

Act of 2007 requires DHS to establish a fully operational NBIC by September 30, 

2008. This statement discusses the status of DHS’s efforts to: (1) Make NBIC fully 

operational by the mandated deadline, and (2) improve the BioWatch program’s 

technology. GAO’s preliminary observations of these two programs are based on our 

ongoing work mandated by the Implementing Recommendations of the 9/11 Commission Act of 2007 to review U.S. biosurveillance efforts. To conduct this work, 

GAO reviewed related statutes; Federal directives; and DHS planning, development, 

and implementation documents on these two initiatives. We also interviewed DHS 

program officials to obtain additional information about NBIC and BioWatch. 

DHS reviewed a draft of this testimony and provided technical comments, which 

were incorporated as appropriate. 

BIOSURVEILLANCE: PRELIMINARY OBSERVATIONS ON DEPARTMENT OF HOMELAND

SECURITY’S BIOSURVEILLANCE INITIATIVES

What GAO Found 

DHS has made progress making NBIC fully operational by September 30, 2008, 

as required by the Implementing Recommendations of the 9/11 Commission Act of 

2007, but it is unclear what operations the center will be capable of carrying out 

at that point. DHS has acquired facilities and hired staff for the center but has not 

yet defined what capabilities the center will have in order to be considered fully 

operational. DHS has also started to coordinate biosurveillance efforts with other 

agencies, but DHS has not yet formalized some key agreements to fulfill NBIC’s integration mission. For example, DHS has signed memoranda of understanding with 

6 of 11 agencies DHS identified to support the operations of NBIC. However, DHS 

has not yet completed other key agreements to, for example, facilitate the technical 

exchange of information, such as data on human health, between NBIC and the 

agencies. In addition, a contractor DHS hired to enhance NBIC’s information technology system delivered an upgrade to the system on April 1, 2008, intended to enhance data integration capabilities. However, before this upgrade can be used effectively, DHS officials said that NBIC will need to train its employees to use the system and negotiate interagency agreements to define the data that the agencies 

using the system will provide. DHS officials expect that NBIC will complete the 

training in early 2009. 

DHS has two ongoing efforts to improve the detection technology used by the 

BioWatch program, which deploys detectors to collect data that are then analyzed 

to detect the presence of specific biological agents. First, the Directorate for Science 

and Technology (S&T) within DHS is developing next-generation detectors for the 

BioWatch program. DHS plans for this new technology to collect air samples and 

automatically test the samples for a broader range of biological agents than the current technology. Under the current system, samples are manually collected and 

taken to a laboratory for analysis. DHS plans to operationally test and evaluate the 

new automatic technology in April 2009 and to begin replacing its existing detection 

technology in 2010. Operational testing and evaluation of the new technology is 

planned to take place in April 2009, about 1 year later than DHS initially planned, 

because S&T officials received revised requirements for the new system about 4 

months before S&T was scheduled to complete development of the system. Second, 

while S&T is completing its work on the new detection technology, DHS is developing an interim solution, managed by the Office of Health Affairs, to enhance its 

current detection technology. This interim solution is intended to automatically analyze air samples for the same number of biological agents currently monitored by 

the BioWatch program. Contingent on successful operational testing and evaluation 

that is to start in November 2008, DHS plans to decide whether to acquire over 100 

of these enhanced detectors. 

Mr. Chairman and Members of the committee: I am pleased to have the opportunity to be here today to discuss some issues associated with the Department of 

Homeland Security’s (DHS) biosurveillance initiatives, specifically the National Biosurveillance Integration Center (NBIC) and the BioWatch program. The United 

States faces potentially dangerous biological threats that occur naturally or may be 

the result of a terrorist attack. New diseases, such as Avian Influenza, West Nile 

virus, and severe acute respiratory syndrome (SARS) have emerged in recent years. 

Infectious diseases have the potential to develop into widespread outbreaks and 

could have significant consequences, such as causing hundreds of thousands of casualties, disrupting and weakening our economy, damaging public morale and con-
14 

1Pub. L. No. 110–53, § 1101, 121 Stat. 266, 375–79 (2007). 2 Id. at § 1102, 121 Stat. at 379. 

fidence, and threatening our national security. In addition to naturally occurring infectious disease outbreaks, the United States faces the possibility that terrorists will 

use biological agents as weapons of mass destruction. Threats of bioterrorism, such 

as anthrax attacks and high-profile disease outbreaks, have drawn attention to the 

need for systems that provide early detection and warning about biological threats, 

known as biosurveillance systems. DHS, in cooperation with various other Federal 

agencies, is developing two major initiatives to provide early detection and warning 

about biological threats: NBIC, a center for integrating information on biological 

events of national significance, which the Implementing Recommendations of the 9/ 

11 Commission Act of 2007 (9/11 Commission Act) mandated DHS to establish and 

make fully operational by September 30, 2008,1 and the BioWatch program, which 

operates systems to test the air for specific biological threats. 

My remarks today will focus on the status of DHS’s efforts to: (1) Make NBIC 

fully operational by the statutorily mandated deadline and (2) improve the technology used by the BioWatch program. Our preliminary observations of these two 

DHS programs are based on our ongoing review of U.S. biosurveillance efforts, as 

required by the 9/11 Commission Act.2 The law mandates that GAO review U.S. biosurveillance efforts at the Federal, State, local, and tribal levels of government. Our 

preliminary observations on NBIC and the BioWatch program are based on reviews 

of DHS planning, development, and implementation documents concerning these initiatives; related statutes and Federal directives; and interviews with DHS officials. 

We interviewed officials from the Office of Health Affairs (OHA) responsible for establishing NBIC and managing the BioWatch program. We also interviewed officials 

from DHS’s Directorate for Science and Technology (S&T), the primary research and 

development office responsible for developing next-generation detection technology 

for BioWatch. We conducted our work from February 2008 to July 2008 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. 

SUMMARY

DHS has made progress making NBIC fully operational by September 30, 2008; 

however, it is unclear what operations the center will be capable of carrying out at 

that point. DHS has faced difficulties completing some key tasks, such as defining 

what capabilities the center will provide once fully operational, formalizing agreements to obtain interagency coordination, and completing work related to the new 

information technology (IT) system. For example, NBIC has made some progress in 

developing its capabilities to be fully operational by September 30, 2008, as mandated by the 9/11 Commission Act, but NBIC has not yet defined the capabilities 

the center will have in order to be considered fully operational. DHS, through NBIC, 

has also started to coordinate interagency biosurveillance efforts and finalized some, 

but not all, key interagency coordination documents. For example, DHS has yet to 

finalize interagency agreements with relevant agencies that describe programmatic, 

financial, and staffing arrangements between NBIC and these agencies. In addition, 

a contractor DHS hired to enhance NBIC’s IT system delivered an upgrade to the 

system on April 1, 2008; however, NBIC officials stated that they need to complete 

additional work before granting other agencies full access to the new system. For 

example, NBIC is still in the process of training employees to use the system and 

negotiating agreement on the data that agencies will provide to NBIS. 

DHS has two ongoing efforts to improve the detection technology used by the 

BioWatch program. First, S&T within DHS is developing new detectors for the 

BioWatch program, a program that deploys detectors to collect data that are then 

analyzed to detect the presence of specific biological agents. These new detectors, 

known as Generation 3.0, are intended to provide additional capabilities and replace 

the existing detection technology beginning in 2010. The new detector technology is 

designed to both collect and automatically test air samples for biological agents, unlike the current system in which samples must be manually collected and taken to 

a laboratory for analysis. DHS officials anticipate that the new technology will reduce the elapsed time between air sampling and detection of a biological threat by 

at least 4 hours and possibly as much as 30 hours. Additionally, the new technology 

is designed to detect more biological agents than the existing technology. Operational testing and evaluation of this technology is scheduled for April 2009, about 
15 

3 According to the 9/11 Commission Act, the term ‘‘member agency’’ means any Federal department or agency that, at the discretion of the head of that department or agency, has entered 

a memorandum of understanding regarding participation in the NBIC. DHS is working with 11 

other Federal agencies to establish NBIC: Department of Defense, Department of Agriculture, 

Department of Health and Human Services, Department of the Interior, Department of State, 

Veteran’s Affairs, Department of Transportation, the Environmental Protection Agency, Postal 

Service, Department of Commerce, and Department of Justice. 4 Homeland Security Presidential Directive (HSPD) 9, Defense of United States Agriculture 

and Food (Jan. 30, 2004), charges Federal agencies to create a new biological threat awareness 

capacity. Additionally, HSPD 10, Biodefense for the 21st Century (Apr. 28, 2004), calls for an 

integrated and comprehensive attack warning system that will assist in recognizing and responding to biological attacks on humans, animals, food, water, agriculture, and environmental 

resources. 5DHS has identified a list of specific biological agents that could pose a health threat if aerosolized and released to the environment. 

a year later than initially planned because OHA provided S&T with revised requirements about 4 months before S&T was scheduled to complete the development of 

the new prototype detector. Second, while S&T completes its work on the new detection technology, OHA is developing an interim solution to enhance the existing detection technology so that it can automatically analyze air samples. Contingent on 

successful operational testing and evaluation that is to begin in November 2008, 

DHS plans to acquire over 100 of the enhanced detectors. 

BACKGROUND

Since the attacks of September 11, 2001, there has been concern that another terrorist attack on U.S. soil could occur involving biological, chemical, radiological, or 

nuclear weapons. Concerns like these have prompted increased Federal attention to 

and investment in national emergency preparedness—that is, the Nation’s ability to 

prevent, protect against, respond to, and recover from large-scale emergency events. 

Effective preparation for, detection of, and response to a major biological event requires effective pre- and post-disaster coordination and cooperation among different 

Federal agencies, levels of government, nongovernmental organizations, and the private sector. In the case of biological threats, detection of biological agents is a first 

step in an effective response to a natural, accidental, or intentional outbreak of a 

biologically caused disease. 

In August 2007, the 9/11 Commission Act required DHS to establish NBIC to detect, as early as possible, a biological event of national concern that presents a risk 

to the United States, or the infrastructure or key assets of the United States. The 

9/11 Commission Act provides that the mission of NBIC is to enhance the capability 

of the Federal Government to: • rapidly identify, characterize, localize, and track a biological event of national 

concern; • integrate and analyze data relating to human health, animal, plant, food, and 

environmental monitoring systems; and, • disseminate alerts to member agencies, and State, local, and tribal governments.3

The 9/11 Commission Act also requires NBIC to be fully operational by September 

30, 2008. 

Prior to the passage of the 9/11 Commission Act, two Presidential directives 

charged Federal agencies to coordinate Federal efforts and create a new biological 

threat awareness capacity to enhance detection and characterization of a biological 

attack.4 In response to these Presidential directives, DHS began the National Biosurveillance Integration System (NBIS) program in 2004 as a means of integrating 

information across Government agencies regarding biological events. The NBIS program developed an IT system, also known as NBIS, to bring together various data 

used for human, animal, and plant health surveillance; environmental monitoring 

data; and intelligence and threat analysis. Subsequently, the 9/11 Commission Act 

established NBIC as the entity responsible for, among other things, developing and 

running the IT system, still known as NBIS. Since it was created in March 2007, 

OHA has overseen NBIS and now the NBIC program office. 

DHS, in cooperation with other Federal agencies, created the BioWatch program 

in 2003 to detect the release of airborne biological agents. The BioWatch program 

deploys detectors which collect data that, when analyzed, can be used to identify biological agents on the BioWatch threat list.5 Current BioWatch detection technology 

contains filters that collect air samples, but the filters must be collected manually, 

and testing of the samples is carried out in State and local public health laboratories. Using this manual process, results are usually obtained within 10 to 34 hours 

of an agent’s detection. BioWatch detectors are currently deployed in 30 cities, and 
16 

local jurisdictions are responsible for the public health response to positive findings 

in the BioWatch program. OHA has responsibility for managing the operations of 

the BioWatch program. S&T, which is the primary research and development arm 

of DHS, is responsible for developing detectors for the BioWatch program. 

DHS HAS MADE PROGRESS IN MAKING NBIC FULLY OPERATIONAL BY THE MANDATED

SEPTEMBER DEADLINE, BUT FACES DIFFICULTIES COMPLETING KEY TASKS

DHS has made progress making NBIC fully operational by September 30, 2008, 

as required by the 9/11 Commission Act, but has faced difficulties completing some 

key tasks, such as defining what capabilities the center will provide once fully operational, formalizing agreements to obtain interagency coordination, and fully implementing its IT system. NBIC has not yet defined what capabilities the center should 

have in place in order to be fully operational. According to NBIC officials, NBIC has 

drafted, but not finalized, planning documents to define these capabilities. In addition, NBIC has initiated coordination with member agencies through memoranda of 

understanding (MOUs) and interagency working groups. NBIC is working to establish additional coordination efforts to enhance NBIC’s integration capabilities. Further, a contractor DHS hired to enhance NBIC’s IT system delivered an upgrade to 

the system on April 1, 2008, but more work remains to be done. For example, member agencies will not have full access to the IT system until NBIC employees have 

been trained to use the system. Additionally, NBIC reports that it continues to negotiate agreements with member agencies on the data they are to provide for the 

IT system. 

Progress Has Been Made, But It Is Unclear What Capabilities NBIC Will Have by 

the September 30, 2008, Deadline 

DHS has made progress making NBIC fully operational by the mandated September 30, 2008, deadline; however, it is unclear what operations the center will be 

capable of carrying out at that point. NBIC has acquired a facility that accommodates office space, a 24-hour watch center, as well as secure areas to handle classified materials. Additionally, in January 2008 NBIC hired a permanent Director to 

oversee NBIC operations. As of July 2008, NBIC has also filled 26 of 37, or 70 percent, of NBIC’s available staff positions, and according to NBIC officials, NBIC is 

in the process of hiring four additional staff members, including a Deputy Director. 

NBIC officials are planning to use contractors to fill the remaining 7 positions. Furthermore, NBIC has also acquired one detailee from a member agency, the Department of Health and Human Services, and is working to acquire additional detailees. 

NBIC has drafted a concept of operations; a finalized version is pending comments 

from NBIC’s member agencies. Officials have also drafted, but not finalized, standard operating procedures. In fiscal year 2008, $8 million were available to NBIC officials to establish the center; officials told us that they recently requested an additional $4.2 million in a reprogramming that DHS has not yet approved. 

NBIC has not yet defined the capabilities the center should have in order to be 

considered fully operational. The 9/11 Commission Act does not define fully operational or what capabilities NBIC needs to have in place by the statutorily mandated September 30, 2008, deadline. NBIC officials told us that they are currently 

trying to define ‘‘fully operational’’ and are drafting detailed plans for the final 90 

days of planning before the deadline. Officials told us that these documents describe 

the details of NBIC’s expected operational capabilities and functions, such as the 

state of their IT system, personnel expectations, analytic capabilities, and include 

specific goals, objectives, milestones, and cost estimates. DHS did not provide us 

with these planning documents because the documents are in draft form. 

NBIC Has Taken Steps to Coordinate With Federal Agencies, But Has Not Formalized Agreements to Obtain Their Cooperation 

NBIC has initiated coordination efforts with 11 Federal agencies but faces difficulties completing formal agreements to obtain their cooperation. Since the new NBIC 

Director started in January 2008, NBIC has organized interagency working groups 

and has finalized MOUs with 6 of the 11 agencies that NBIC identified as important 

to the operational needs of the center. NBIC has an interagency working group consisting of these 11 agencies, in addition to DHS, that first met under the direction 

of the new Director in March 2008. As part of the interagency working group, DHS 

officials stated, NBIC has created a sub-working group that meets on a weekly basis 

to discuss issues such as the daily operations of NBIC, reporting requirements, and 

data-sharing issues. NBIC also organized an interagency oversight council, which 

includes representatives from member agencies, private-sector organizations, and 

academia, to provide technical oversight and guidance in the development and implementation of NBIC’s operations. The oversight council plans to meet for the first 
17 

6The five departments and agencies with pending MOUs include the Department of Commerce, the Environmental Protection Agency, Department of Justice, United States Postal Service, and Department of Veterans Affairs. 

time in August 2008. NBIC has begun facilitating interagency coordination while 

continuing to implement additional elements of the program. For example, NBIC officials told us that they helped coordinate the Federal Government’s efforts to deal 

with the recent national salmonella outbreak, while simultaneously continuing to 

work on making NBIC fully operational to meet the September 30, 2008, deadline. 

As part of its efforts to establish interagency coordination, NBIC is seeking to formalize its relationship with Federal agencies through three types of documents: 

MOUs, interagency security agreements (ISAs), and interagency agreements (IAAs). 

First, DHS is asking Federal agencies to sign MOUs to confirm the agency or department’s initial agreement to participate in NBIC as a member agency. Second, 

DHS is asking agencies to sign ISAs that formalize the technical exchange of information, such as data on human health, between NBIC and these agencies. Finally, 

DHS is asking agencies to sign IAAs that define programmatic, financial, and staffing arrangements between NBIC and these agencies. As part of the IAAs, agencies 

are to agree to provide detailees to work at NBIC. These detailees will provide subject-matter expertise and facilitate NBIC coordination with their respective home 

department or agency. 

To date, NBIC and potential member agencies have finalized 6 of 11 MOUs; however, they have not finalized any ISAs or IAAs. DHS has signed MOUs with the 

Departments of Defense, Agriculture, Health and Human Services, Interior, State, 

and Transportation. DHS is still working to finalize MOUs with another 5 agencies 

to formalize their membership in NBIC.6 NBIC does not have ISAs or IAAs in place 

with any of its current and potential member agencies. According to NBIC officials, 

one difficulty in finalizing the ISAs is due, in part, to defining the data-sharing arrangements with member agencies given the constraints on arrangements for sharing data imposed by the traditional roles of these agencies. For example, interagency coordination for the purposes of characterizing a biological event may require 

data that NBIC member agencies have not previously shared with other agencies. 

In addition, DHS faces difficulty finalizing IAAs, the formal mechanisms through 

which NBIC obtains detailees from Federal agencies. In the absence of IAAs, according to NBIC’s draft concept of operations, the center cannot effectively perform its 

integration and analytical mission without the subject-matter knowledge from interagency detailees. As of July 2008, NBIC has been able to secure one detailee from 

a member agency. Officials were unable to predict how many additional MOUs, 

ISAs, IAAs, or detailees NBIC will have in place by September 30, 2008. 

NBIC Recently Upgraded Its IT System, But Additional Work Remains 

A contractor DHS hired to enhance NBIC’s IT system delivered an upgrade to the 

system in April 2008; however, NBIC officials stated that they need to complete additional work before granting member agencies full access to the system. The system, known as NBIS, provides tools to enhance NBIC’s data integration capabilities 

and collaboration with member agencies. Such tools include a worldwide geographical map displaying emergent and ongoing adverse health events, an assessment of the homeland security implications of those events, a library of all referenced data, and general disease and situational reports. NBIC officials told us 

that additional work needs to be done before giving member agencies full access to 

the system. For example, NBIC does not have interagency security agreements in 

place with member agencies that specify the data that agencies will share with the 

system. In addition, as NBIC officials work with the NBIS system, they are identifying additional improvements that need to be made to the system. Furthermore, 

while member agencies will have access to some of the individual tools that are a 

part of NBIS, until NBIC analysts have been trained to use NBIS, member agencies 

will not have full access to all of the system’s interagency collaboration functions. 

Officials estimate that training will not be completed until at least early 2009. 

DHS HAS TWO ONGOING EFFORTS TO IMPROVE THE BIOWATCH TECHNOLOGY, WHICH

MAY DECREASE DETECTION TIME OR INCREASE THE NUMBER OF AGENTS THAT CAN

BE IDENTIFIED

DHS has two ongoing efforts to improve the detection technology used by the 

BioWatch program. S&T is developing a new technology. OHA is developing an interim solution to enhance the detectors currently in use. 

S&T is developing new detection technology known as Generation 3.0 which 

would replace the existing technology used by the BioWatch program. This new 

technology is to provide a fully automated detector which not only collects air sam-
18 

ples but also analyzes them for threats. The current technology collects air samples 

which are periodically manually removed from the equipment and taken to a laboratory for analysis, a process that could take 10 to 34 hours. Officials stated that automating analysis of air samples could reduce the elapsed time between air sampling 

and testing it for threats from the current 10 to 34 hours to 4 to 6 hours, reducing 

detection time by at least 4 hours and possibly as much as 30 hours. In addition 

to the automated detection capability, Generation 3.0 is to detect a broader range 

of identified biological agents to eventually cover all the biological agents on the 

BioWatch threat list—a list of specific biological agents that could pose a health 

threat if aerosolized and released to the environment. The estimated cost for acquiring these detectors is $80,000 to $90,000 per unit, with yearly operation and maintenance costs of $12,000 to $41,000 per unit. 

Operational testing and evaluation of this technology is scheduled for April 2009, 

about a year later than initially planned because OHA provided S&T with revised 

functional requirements about 4 months before S&T was scheduled to complete the 

Generation 3.0 prototype detector. S&T developed the original requirements for the 

Generation 3.0 technology, which required the automatic detectors to, among other 

things, operate continuously, detect more biological threats, be less expensive to operate, and be deployed in both indoor and outdoor environments. S&T planned to 

complete the development of the hardware and software and conduct field tests of 

its prototype Generation 3.0 detectors by April 2008, at which point OHA was to 

take responsibility for final operational testing and evaluation of the detectors. However, OHA provided S&T with new requirements for the Generation 3.0 detector in 

January 2008, which delayed operational testing and evaluation by 1 year, from 

April 2008 to April 2009. The new requirements included additional requirements 

and provided additional details for some of the original requirements. For example, 

OHA’s new requirements contain restrictions for the size and weight of the Generation 3.0 detector which were not specified in the original requirements. As a result 

of the 1-year delay, S&T also designed an additional field test for the Generation 

3.0 prototypes, scheduled to begin in the first quarter of fiscal year 2009, which will 

occur in an urban environment and allow for the prototypes to be tested in realworld conditions. According to S&T and OHA officials, the Generation 3.0 detector 

will ultimately replace all current BioWatch detectors by 2013, with initial deployment beginning in 2010. 

While S&T is completing is work on the Generation 3.0 detectors, OHA is developing an interim solution to enhance the detectors currently in use by adding the 

capability to automatically analyze air samples for some biological agents. OHA’s interim technology, known as Generation 2.5, is intended to add the capability to 

automatically analyze air samples for the same number of biological agents currently monitored by the existing BioWatch detector technology. However, the enhanced detectors will not have the capability to identify additional biological agents 

listed on the BioWatch threat list. According to OHA officials, Generation 2.5 detectors will, like Generation 3.0 detectors, reduce the elapsed time between sampling 

the air and detecting a biological agent by at least 4 hours and possibly as much 

as 30 hours. Further, OHA officials stated that they plan to operationally test and 

evaluate new prototype detectors beginning in November 2008 and to acquire over 

100 of these new detectors, contingent on successful completion of operational testing and evaluation. The estimated cost for acquiring and testing these detectors is 

$120,000 per unit, with yearly maintenance costs of $65,000 to $72,000 per unit. According to DHS officials, OHA plans to deploy these new detectors both indoors and 

outdoors; however, no procedural guidance exists for responding to positive results 

from detectors placed indoors. According to OHA officials, they plan to develop this 

guidance by October 2008 and apply it to all future BioWatch detectors deployed 

indoors. 

Mr. Chairman, this completes my prepared statement. I would be happy to respond to any questions you or other Members of the committee may have at this 

time. 

Mr. LANGEVIN. Thank you, Mr. Jenkins. 

The Chair now recognizes Mr. Wilson for 5 minutes. 

STATEMENT OF JAMES M. WILSON, V, MD, CHIEF TECHNICAL 

OFFICER AND CHIEF SCIENTIST, VERATECT CORPORATION 

Dr. WILSON. Thank you, sir. 

Chairman Langevin, Ranking Member McCaul, and Members of 

the subcommittee, I appreciate the opportunity to testify today 
19 

about the Department of Homeland Security’s National Biosurveillance Integration Center, NBIC. 

My name is Dr. James Wilson, chief scientist and chief technical 

officer at Veratect Corporation, a privately funded company, with 

offices in Seattle, Chicago, and Alexandria, Virginia. 

For more than 10 years now, I have been pursuing a mission of 

early disease detection and tracking. I have had the privilege of 

working with and for the World Health Organization, NASA, 

NOAA, the U.S. Army, DHS–NBIC, and several other Federal organizations, all with the intention of developing the art and science 

of timely, accurate, sensitive, and specific detection and warning 

for disease early enough to do something about it before it can 

spread via the global transportation and commerce grid. 

Perhaps the most relevant points in my career for this discussion 

today are my role as the first chief of operations at NBIC, principal 

investigator of Project Argus, founding member of the Biosurveillance Indication and Analysis Community, BIWAC, and my current 

role at Veratect. 

I am here today to speak about the national biosurveillance integration mission and what it would take to strengthen and hasten 

NBIC toward the successful completion of its congressional mandate to build and operate an integrated biological threat detection, 

tracking, and warning system. 

I am also here as a physician and U.S. citizen with deep concerns 

about how to best meet the growing threat of global disease. The 

threat is real. The diversity of the threats is growing, and increasing globalization only heightens our risk. So what are we as a Nation doing about the threat? 

NBIC is mandated to protect the United States from biological 

threats through effective early warning. Execution has fallen short, 

however, due to one basic point: Every warning system needs effective early detection. The earlier the better. Like hurricane, tornado, 

and tsunami warning systems, early, accurate, and specific warning of inbound disease is key to avoiding disaster. 

I was fortunate to lead the team at Project Argus that represented the best available system at the time. Despite our best efforts, there were operational restrictions which prevented Argus 

from reaching its full potential. Most importantly, we were unable 

to analyze domestic data, leaving a tremendous blind spot in the 

system. In addition, we were unable to work with international 

partners in order to validate our findings. We were also unable to 

share vital information with the global health community. These 

restrictions were mission crippling. 

Earlier this year, we set out to create from the ground up a more 

advanced methodology and operational framework that provides 

truly global reach, including domestic coverage, and allows us to 

work with private corporations and nonprofit organizations. This 

new approach is not trivial. Our ForeShadow engine and VeraSight 

interface have greatly expanded the number of information sources 

and the ability to detect and track emerging biological events in 

near realtime. Veratect’s more open framework also allows for 

rapid ground verification to facilitate early warning and help initiate proactive response by working closely with both public and 

private resources around the world. 
20 

One of our key observations over the past 10 years is it is the 

critical importance of human analysis. Human-powered technology 

drives our ability to detect diseases earlier and more accurately 

than at any time in history. 

The senior analytic team and I that I assembled at Argus is now 

at Veratect, where we now have more than 230 person years of 

international experience and nearly 100 person years within this 

new professional discipline. We currently monitor over 200 diseases 

that affect humans and animals, and our methodology has expanded to include monitoring for food safety. For the first time in 

history, we can now do more than simply deal with the aftermath 

of such disasters as HIV/AIDS, SARS, or the H3N2 vaccine drift 

this past winter, which is found in this commentary here in Nature 

this month. The team that is now at Veratect detected this new 

strain of influenza a full 6 weeks in advance of the WHO consultation on the composition of the influenza vaccine for the Northern 

Hemisphere in February 2007. 

We stand at the threshold of a new era in public health, where 

we can detect and perhaps anticipate public health crises and disasters through Veratect’s groundbreaking methodology and global 

partnerships. I am here not just as a professional of this new discipline but as a father and a husband who is worried about these 

emerging threats and the potential effect on my family. This is personal for all of us. Everyone in the world is a stakeholder in what 

we do here today. 

Once again, I am grateful for this opportunity to testify, and I 

stand ready to answer any questions you might have. Thank you. 

[The statement of Dr. Wilson follows:] 

PREPARED STATEMENT OF JAMES M. WILSON, V 

JULY 16, 2008 

Chairman Langevin, Ranking Member McCaul and Members of the committee, I 

appreciate the opportunity to testify today about the Department of Homeland Security National Biosurveillance Integration Center (NBIC). 

My name is Dr. James Wilson, Chief Scientist and Chief Technical Officer of 

Veratect Corporation, a privately funded company with offices in Seattle, Chicago 

and Alexandria, Virginia. For more than 10 years now, I have been pursuing a mission of early disease detection and tracking. I have had the privilege to have worked 

with and for the World Health Organization, NASA, NOAA, U.S. Army, DHS–NBIC 

and several other Federal organizations, all with the intention of developing the art 

and science of timely, accurate, sensitive and specific detection and warning for disease—early enough to do something about it before it enters the global transportation and commerce grid. Perhaps the most relevant points in my career, for this 

discussion today, are my role as the first Chief of Operations at NBIC, Principal Investigator of Project Argus, founding member of the Biosurveillance Indication and 

Warning Analysis Community (BIWAC) and my current role at Veratect. 

Today I would like to cover five things: 

(1) A quick review of biological threats past to present. 

(2) What our Nation’s response has been to date. 

(3) Speak to NBIC’s mandate as it stands today, and what will be required for 

it to succeed. 

(4) Share with you the next generation in early detection methodologies that we 

have developed, and are improving at Veratect. 

(5) Suggest how Veratect can support NBIC and the National Biosurveillance 

Integration Mission. 

BRIEF HISTORY OF BIOLOGICAL THREATS, 1918 TO PRESENT

I would like to begin by sharing some historical context as we review past and 

present diseases. In the late 1990’s, I worked with the World Health Organization 
21 

and NASA to examine environmental and climatic phenomena in Africa potentially 

associated with the emergence of the Ebola virus. This work led to the first model 

for rapid identification of ‘‘conditions favorable’’ for Ebola epidemics using satellite 

imagery. It was during this time period that WHO and its partners initiated the 

Global Outbreak Alert and Response Network (GOARN), the Canadians created the 

Global Public Health Intelligence Network (GPHIN), and ProMED was started; indeed it was the birth of what we would later refer to as a new professional discipline 

in monitoring publicly available global information. 

In 2003, several colleagues and I applied this idea to West Nile virus, utilizing 

the concept of ‘‘graded alerting’’ married to ‘‘graded response’’, where clues of the 

emergence of a biological event sensitize a network of biosurveillance analysts to 

begin actively searching for more information that may ultimately yield a response 

action. That work evolved into the National Library of Medicine (NLM)-sponsored 

Project Sentinel, which examined the role of syndromic surveillance in biodefense. 

The most substantial realization of Project Sentinel was the possibility of connecting 

a global biosurveillance system seamlessly to hospitals in America using information 

technology so that patients would not be seen by American healthcare workers without access to immediate situational awareness of what that patient might have been 

exposed to while traveling overseas. This was a poignant note when considering the 

vulnerability of Toronto’s hospitals in 2003 when they unknowingly admitted suspect and confirmed cases of SARS that prompted quarantine and closure of their 

facilities. 

One of the things that history is teaching us now is that, in the context of influenza season, the impact on the medical grid is considered substantial, but brief. 

However, in the case of a pandemic, the possibility of a ‘‘medical blackout’’ becomes 

a serious consideration. America’s hospitals are not linked to near real-time situational awareness, which is a serious issue given biological hazards can easily 

translocate undetected and un-forewarned in hours through the air traffic grid from 

Africa to New York and Asia to Los Angeles. 

Clearly, globalization and more specifically the transportation grid (as it has become more developed) has heightened the risk of transnational spread of disease. 

Just last week we saw a case of Marburg hemorrhagic fever transferred by flight 

from Uganda to the Netherlands. Currently, the United States is experiencing the 

worst measles epidemic in 10 years, which has spread to 15 States thanks to foreign 

introduction by returning travelers to the United States. Of course, the Members 

are aware of the current national salmonella food contamination event that CDC 

and FDA are struggling to investigate, courtesy of our globalized commerce. 

According to the U.S. Department of Transportation, the total bi-directional exchange of direct, non-stop air traffic between the United States and the rest of the 

world was 81.4 million passengers in 1990. By 2005, bi-directional air traffic between the United States and the rest of the world increased by 182 percent to 148.6 

million. In 1990, bi-directional exchange between China and the United States was 

84,308 passengers with 3 Chinese cities connecting to 7 U.S. cities. By 2005, this 

had increased to 1.5 million passengers, which is an increase of 1,819 percent with 

9 Chinese cities connecting to 27 U.S. cities. 

It is obvious that international air traffic to and from the United States is steadily 

increasing. However, translocation of disease by aircraft has been reported with 

community exposures. Historically, the influenza pandemics of 1918, 1957 and 1968 

and the HIV/AIDS pandemic were brought to the United States through transoceanic ships and airplanes. Pathogens such as adenovirus, Chikungunya virus, the 

cholera bacterium, dengue virus, Ebola and Margburg hemorrhagic fever viruses, 

hepatitis A virus, human metapneumovirus, legionella bacterium, the malaria parasite, measles virus, mycoplasma bacterium, norovirus, parainfluenza virus, respiratory syncytial virus, rhinovirus, salmonella bacterium, SARS-coronavirus, both 

seasonal and pandemic influenza virus, shigella bacterium, smallpox virus (historically), treatable tuberculosis as well as Multi-Drug Resistant (MDR–TB) and Extensively Drug Resistant (XDR–TB) forms of the bacteria, West Nile virus, and yellow 

fever virus have all been documented to have been vectored by aircraft. 

But no historical review of disease threats would be complete without some understanding of the 1918 Spanish influenza–H1N1, which infected one-third of the 

world’s 1.5 billion citizens and killed over 50 million of them. This pandemic took 

almost a year to spread from its origin to full global involvement. A contemporary 

1918-like public health disaster could kill 1.9 million Americans and spread by passenger jets in as little as 3 to 4 weeks from source to global involvement. Our team 

has serious concerns that such an event may result in sustained ‘‘medical blackouts’’, critical infrastructure failures and acute, overwhelming socioeconomic social 

disruption. Further, economic research suggests a possible 8- to 10-year global economic depression in a multi-trillion cost to the world economy. Such a scenario 
22 

would have serious implications for our ability to project our military might, maintain our homeland security, and our national security, economy and society. 

So where are we today—what have we done? 

The United States stands at ever-present and increasing risk for further introductions of exotic infectious disease with potentially serious consequences to the Nation. 

From my perspective in a near real-time operations environment (which will be described below), we have hours or at most a few days to respond to an emergent 

threat. In other words, while consideration of intentional release or bioterrorism is 

important and key to national security, naturally occurring threats are more likely 

and have occurred regularly throughout history. Time-sensitive public health response is the best counter measure we have for both. Early detection is the key to 

early response and early containment. 

My initial work to anticipate the emergence of Ebola, explore graded surveillance 

for West Nile Virus and connectivity to hospital-based disease surveillance made 

evident the significant limitations of situational awareness relating to emerging 

global biological threats among our medical, veterinary, public health, and homeland security communities. We concluded that, particularly with regard to highly 

communicable diseases, there was a critical need for identifying the earliest possible 

indications and warnings of foreign biological threats to enhance our ability to 

proactively implement effective countermeasures. Again, early detection coupled 

with early response means early control. 

From 2004 to 2005, I volunteered my services as the Biodefense Technical Advisor 

of the U.S. Army Medical Research and Material Command’s Telemedicine and Advanced Technology Research Center (USAMRMC–TATRC) to serve as a member of 

the National Biosurveillance Integration System (NBIS) Concept Design Review 

panel. In late 2005, I actively canvassed the Department of Homeland Security and 

the Homeland Security Council to assist with the operational activation of the National Biosurveillance Integration Center (NBIC). As its first Chief of Operations, 

and in conjunction with the talented people on the NBIC team, we drafted the first 

concept of operation. 

Except for BioWatch, we did not have access to operationally relevant biosurveillance information, because it simply did not exist at that point. While at DHS– 

NBIC, I interacted with representatives of Customs and Border Patrol, Immigrations and Customs Enforcement, the Transportation Security Administration, and 

the U.S. Coast Guard who all told me stories of passengers and immigrants who 

presented with illness at the border. It was my impression that the coordination of 

situational awareness for these issues with CDC’s Division of Quarantine and Population Migration would be a powerful adjunct within NBIC’s mission of biosurveillance. It was in these early days we realized the need for a novel professional analytic discipline for integrated biosurveillance. With time, we came to understand 

that additional funding in a different setting was essential to develop the analytical 

methodology and discipline that would be so crucial to this historically unprecedented capability. 

Up to this point, NBIC had configured itself operationally in the manner of a military operations center not unlike the North American Aerospace Defense Command 

(NORAD). This included mission analysis, concept of operations and an operations 

plan that was implemented using information feeds from sources such as BioWatch, 

BioSense, Argus (further addressed below) and other sources of information. This 

was a historically unique operations center in my opinion in that we were now beginning to function with integrated and prioritized reporting requirements across 

the Federal agencies. Unfortunately, the structure of the program was not optimal 

for its Federal partners because it needed to be established in a neutral environment that brought Federal agencies together as equals. 

After my departure, NBIC focused heavily on building formal relationships with 

the Federal community. I did not see much support for detection subsystems nor 

substantive improvement in their early warning capability. I found there to be limited operational, routine, near real-time engagement between NBIC, their Federal 

partners and State and local authorities. However, NBIC’s continued participation 

as a member of the Biosurveillance Indication and Warning Analysis Community 

(BIWAC) was an excellent step in the right direction. I will explain BIWAC in more 

detail below. It is my opinion the formal relationships needed for NBIC’s success 

will take years to develop, meanwhile the threat space continues to increase in complexity. 

RESPONSE TO DATE, THE CREATION OF THE ARGUS PROTOTYPE

Due in part to the emergence of SARS in southern China in 2002 and 2003 and 

the recent Highly Pathogenic Avian Influenza–H5N1 pandemic concern, DHS and 
23 

the Intelligence Technology Innovation Center (ITIC) supported the activation of 

Project Argus in late 2004. Project Argus was established as a prototype research 

effort to explore the use of indicators to detect and track biological events, crises 

and disasters. I served as the Principal Investigator while serving as a faculty member of the Division of Infectious Disease, Department of Pediatrics, Georgetown University Medical Center. It was during the research and development phase of Argus 

that I also volunteered by services to the NBIS Concept Design review and later 

as the first Chief of Operations of the NBIC. Therefore, the design of both NBIC 

and the Argus prototype became synergistic. 

While at Georgetown University (we were housed at GU for convenience with little interaction with the rest of campus and no independent support from the university), we applied established proven methodologies to what would become a new 

analytic and professional discipline in biological event detection and tracking with 

a full time staff of cultural and linguistic and subject matter experts and analysts 

based upon state-of-the-art technology provided by the MITRE Corporation. The approach is based on one of the recommendations of the 9/11 Commission to collect, 

analyze and correlate data from the world wide web as a source for information 

about indicators of social disruption caused by illness and disease. Although simple 

in concept it was an extremely complex system. The sponsors of our work deserve 

the Nation’s thanks for having the courage to back our idea—which in retrospect 

is one of the most powerful national security ideas to have emerged from the post9/11 period. We benefited from the enthusiastic intellectual support of many parts 

of the U.S. Government including CDC, USDA, DoD combatant commands around 

the world, and many others. 

In 2006, Congress supported activation of the Argus Research Operations Center, 

which was to be a prototype operations center for infectious disease event detection 

and tracking based on the methodology that we developed. Our mission was to monitor the world for the emergence and spread of H5N1 Avian Influenza. We later voluntarily expanded this mission to include 140 diseases the effect both animals and 

humans globally at no additional cost to the Federal Government. 

At this point I became Chief of the Argus Research Operations Center (AROC), 

but remained in strong support of NBIC and the National Biosurveillance Integration mission. It was my opinion that NBIC would not be able to achieve its objectives without an adequate detection subsystem; therefore I chose to focus my efforts 

on Argus and support NBIC from Argus. 

At our peak capacity, we estimated we were accessing over a million pieces of 

open source information daily covering every country in the world (except the 

United States) that resulted in the production of, on average, 200 reports per day. 

Using a disease event warning system modeled after NOAA’s National Weather 

Service, we issued Warnings, Watches, and Advisories in accordance with guidelines 

agreed upon by our research partners in the Federal Government. On average, we 

maintained 15 Advisories, 5 Watches, and 2 Warnings active on our Watchboard at 

any given time, with 2,200 individual case files of socially disruptive biological 

events maintained and monitored daily in over 170 countries involving 130 disease 

entities affecting humans or animals. We reached a maximum load of 3,300 individual case files maintained and monitored daily during the winter of 2007. 

This information, as provided to our mostly Federal user community, sensitized 

them to be vigilant for the most concerning biological events in the world; this vigilance occasionally resulted in proactive requests for more information by our partners such as CDC and USDA. This in turn, contributed to the United States’ participation in the International Health Regulations through proactive information sharing with WHO and our international partners. Since the program had begun, we 

logged over 30,000 biological events in varying stages of social disruption throughout the world involving pathogens such as H5N1 avian influenza, other influenza 

strains, Ebola virus, cholera, and other exotic pathogens. Of note, while the majority 

of these events were naturally occurring, this capability identified several laboratory 

accidents and occasionally allegations of intentional use of biological agents. 

Upon invitation by CDC, we presented the results of our efforts to the G8 Health 

Security Advisory Group in February 2008. To the best of our knowledge, our approach achieved unprecedented operational milestones in comparison to the leading 

global biological event detection and tracking systems such as ProMED, the Global 

Public Health Intelligence Network (GPHIN), HealthMap and MedISys. One of the 

key observations by the G8 members was a unanimous desire for there to be a 

human interface between the raw data and elicited warning information; there was 

strong support for nurturing a new professional discipline devoted to near real time 

operational biosurveillance. 

The following examples highlight some of our achievements: 
24 

• The operations team at Argus, the majority of whom are now working for 

Veratect, served the country as the lead tactical global event detection team for 

H5N1 avian influenza and were the first group in the world to detect the expansion of H5N1 from southern China to Russia and then Eastern Europe. During 

the winter of 2007, we filed over 12,000 reports of events possibly related to 

H5N1 avian influenza. • In late 2004 and early 2005, we participated in the tsunami response by providing daily situational awareness reports to humanitarian responders. In commenting on our operations, the U.S. Pacific Command wrote, ‘‘Information is 

power only when it’s shared. The situational awareness that portions of Argus 

provided during tsunami relief efforts was an impressive attention step. We see 

some tremendous opportunities and value added for this capability within our 

area of operational responsibility, which literally covers half the globe. Thanks 

for keeping our situational awareness up during difficult times.’’ • On August 3, 2007, this team was the first to notify the U.S. Government of 

undiagnosed vesicular disease in cattle in Surrey, United Kingdom that later 

was diagnosed as hoof-and-mouth disease (FMD). Of additional interest, this 

event was later found to be the result of a laboratory accident, and intentional 

release was explored as a possible etiology but later discounted. The Members 

may recall the tremendous economic damage observed during the last epidemic 

of FMD in the United Kingdom in 2001. 

• On August 27, 2007, we were the first to report indications of the Ebola epidemic in Kasai, Democratic Republic of the Congo. This information was made 

available immediately to CDC, and other members of the Federal user community. CDC’s collaboration in rapid access to ground verification information 

through its partnership with WHO and other international partners was impressive, as it highlighted the potential reduction of the time between initial 

event detection to ground verification to hours and days as opposed to weeks 

or months. Again, early detection plus early response equals containment. 

H3N2 VACCINE DRIFT

Influenza kills an estimated 250,000 to 500,000 people globally each year. While 

monitoring the current pandemic threat of H5N1 avian influenza, the team also 

monitored all influenza strains in support of global influenza disease monitoring. 

During the winter of 2006 and 2007, the team issued nearly 3,000 event reports 

across 128 countries and 27 languages, which included 181 Advisories, 58 Watches, 

and 38 Warnings. Our team identified hundreds of reports of a type A/H3N2 influenza virus that appeared to have drifted away from the current vaccine strain of 

H3N2 beginning in early January 2007 in Beijing, China, 6 weeks prior to the WHO 

Consultation on the Composition of Influenza Vaccine for the Northern Hemisphere. 

We later found similar reports in a multitude of countries and collaboratively 

worked with CDC to track this important finding. The value of this information was 

validated when the World Health Organization and its partners recommended a 

change in the southern hemisphere influenza vaccine to include an updated H3N2 

strain. 

The most important lesson from the H3N2 vaccine failure is not just the need for 

a robust comprehensive early detection system, but open and ongoing information 

exchange between Government agencies and other global health organizations. The 

lack of transparency to the vaccine development process has resulted in unnecessary 

deaths here in the United States. 

During the subsequent 2007 and 2008 influenza season in the United States, the 

northern hemisphere vaccine for the type A/H3N2 virus provided suboptimal coverage at 58 percent effectiveness. This does not mean the vaccine was not helpful 

in terms of reducing the severity and burden of disease. However, although the vaccine achieved some degree of coverage, it was less effective than vaccines used in 

previous years due to the strain mismatch. The 2007 and 2008 influenza season was 

severe, with pneumonia and influenza-related mortality above epidemic threshold 

for 19 consecutive weeks compared to an 11 consecutive week maximum documented in the prior three seasons. This represents a 170 percent increase in seasonal deaths seen since the 2004 and 2005 season. Forty-nine States ultimately reported widespread transmission. In February, one physician commented in ProMED, 

‘‘I have not seen in my 30 years of practice such a relatively large number of patients presenting with documented influenza vaccine ‘failure’.’’ 

SHORTCOMINGS OF THE PROTOTYPE

Unfortunately, by operational design, the prototype was not able to monitor what 

occurred with that strain of influenza here within the United States. From CDC, 
25 

we learned that there had been an increase in H3N2 clustered initially around regions of the United States connected directly to China by international air flights. 

Later laboratory reports from CDC indicated this virus had drifted away from the 

existing vaccine strain. We noted that the very same week we became concerned 

about reports in Beijing of an unusual strain of H3N2, vaccine-drifted H3N2 isolates 

were reported in U.S. cities connected to Beijing by direct air traffic. We did the 

best we could do with the prototype, but it was not adequate. If precise surveillance 

of influenza ‘‘hot spots’’ was acted upon with vigorous sampling, we believe history 

might have been different. 

Let’s be clear here. As illustrated in the July 10, 2008 issue of Nature magazine, 

the northern hemisphere, including the United States, missed an opportunity for anticipating a bad season of influenza because: (1) Information was not used 

proactively to acquire influenza samples from suspicious event/areas in the world, 

and (2) our most mission critical surveillance was blinded at home. This was one 

of the biggest difficulties with the prior system as it was set up at Georgetown. 

NBIC MANDATE AND THE BIWAC

For NBIC to successfully execute its mission, it needs to leverage the experience 

of its Federal partners. One of the early examples of this was the working relationship of NBIC and BIWAC. 

To facilitate operational validation, my colleagues and I initiated the creation of 

the unofficial, Federal Biological Indication and Warning Analysis Community 

(BIWAC). As mentioned above, it was BIWAC that reviewed our reporting requirements with us on a quarterly basis to ensure proper product alignment with the 

user. BIWAC currently includes CDC’s Global Disease Detection team; USDA’s Centers for Epidemiology and Animal Health (CEAH); DHS’ National Biosurveillance 

Integration Center; the Armed Forces Medical Intelligence Center; other Intelligence 

Community organizations; the Defense Threat Reduction Agency; and the U.S. Strategic Command Center for Combating Weapons of Mass Destruction. 

The BIWAC created a central clearing base where each member contributed what 

he or she knew about emerging disease and to quickly determine coordinated next 

steps that included event verification and, in some cases, actual ground response. 

To enhance this process, we activated Project Wildfire, which was an experimental 

information sharing system that enabled near-real time, unclassified dialog among 

the BIWAC partners. Wildfire, although experimental, attracted a substantial 

amount of Federal use; for the first time, we saw the power of the National Biosurveillance Integration Mission in the daily activities of the BIWAC. 

The success of BIWAC and the Wildfire experiment was tempered by the observation that ground verification of biological event information was severely limited 

both in terms of types of disease covered as well as geographic coverage. We realized 

that the actionability of the information was therefore impaired without near realtime interaction with such international partners as NGO’s (who are often on the 

front lines as diseases emerge) and U.N. organizations. One key implication was a 

requirement for a near real-time functioning global network. Another implication 

was the realization that there will be times when we will be unable to verify warning information in the face of daily, nonstop air traffic. A recent example of this 

would be SARS in 2003, where by the time a global alert was issued, the disease 

was already present in eight countries, including the United States. 

The committee is already familiar with the fact SARS was present in China many 

months before WHO awareness and the Global Alert was not issued until eight 

countries (including the United States) were already affected. It took 4 months to 

interrupt all chains of transmission that ultimately affected 27 countries on all continents except Antarctica. I would point out the same phenomena has occurred in 

the past including the 1957 and 1968 pandemics. Local authorities in Hong Kong 

reported unusual respiratory disease that inundated multiple urban sectors of their 

city nearly a month in advance of WHO’s public acknowledgement of a global threat 

referred to as a ‘‘pandemic’’. By then the disease was already in the air traffic grid. 

I will note here there was evidence in both pandemics that Mainland Chinese 

public reporting of unusual respiratory disease preceded reporting in Hong Kong by 

at least several weeks. In summary, the 1957 and 1968 pandemics and 2002–2003 

SARS all were reported at the local level well in advance of national Ministries of 

Health and WHO awareness or the issuance of a warning to the world. Again, nearreal time global disease detection and tracking is essential for our Nation. 

VERATECT AND THE FUTURE OF BIOSURVEILLANCE

The Argus program, although a successful prototype, had two critical flaws. First, 

we were unable to extend our process to include domestic biological event detection 
26 

and tracking. Second, we were unable to build global partnerships with organizations whose missions could be greatly enhanced with this information. This was concerning as we realized other natural hazard warning systems such as tornado forecasting in the 1950’s came under public scrutiny and criticism when it was discovered that a successful forecast of a deadly tornado was not shared by the military 

with the local community that received the onslaught of the storm. What was more 

important was not the high false-positive rate but that a successful forecast could 

have provided hours of lifesaving warning beforehand. We saw the Argus program 

coming under similar scrutiny some day; our team felt we had an ethical and moral 

responsibility to address this concern. 

Because of these mission-crippling limitations, all the founding members and 

many of the most skilled analysts from the original Argus team decided to leave the 

prototype program and begin anew in a private industry environment, the Veratect 

Corporation. 

Veratect’s mission is to provide the earliest detection of threats to human, plant 

and animal life while empowering corporations, Government organizations, NGO’s 

and global citizens with trusted and actionable information. 

Our domestic capabilities and global partnerships, together with Veratect’s new 

ForeShadowTM operating environment and VeraSightTM interface represent a significant step forward in the early detection and 24×7 tracking of biological events 

that empowers early warning and response from a broad range of private and public 

stakeholders that share these same risks. Our team of cultural and linguist interpreters with deep domain experience in recognizing pathogens at their earliest 

emergence represent 230∂ person years of international experience and nearly 100 

person years of experience in this new and proven professional discipline. 

With nearly five times the sources of the prototype, we have an estimated coverage of 82 percent of the world’s population now, in near real time. By the end of 

2008, we will have expanded this coverage to more then 90 percent. Additionally, 

we are in discussions to have access to more than a quarter-million correspondents 

on the ground globally to support near real-time ground truth verification. We stand 

ready to not only meet the needs of DHS and other Federal agencies, but also local, 

tribal, and territorial governments in all 50 States. We currently monitor over 200 

diseases that affect humans or animals, and our methodology is being expanded to 

include monitoring for biothreats to food security and crop disease. 

For this approach to be successful, there is an absolute requirement for human 

analysts who serve as the intermediary between the raw data and the interface with 

those who may take further action like CDC or USDA. Having a close relationship 

with these users ensures we maintain a proper level of sensitivity and specificity, 

as well as conduct continual quality assurance and reviews of our standard operating procedures. This distinguishes our efforts from that of other systems that 

produce raw data outputs such as HealthMap. As mentioned earlier, the G8 Health 

Security Advisory Group, it was clear the G8 members were more interested in humans serving as an interface with the data versus being shown raw, unmediated 

data outputs. 

VERATECT, NBIC AND THE GLOBAL MISSION

The team at Veratect has a unique perspective of what NBIC should do to meet 

the congressionally mandated mission objectives. Members of our team at Veratect 

have worked closely with DHS-NBIC from the very beginning. For the last 2 years, 

our team has been an important source of information for the entire Federal Government in the support of our Nation’s biosecurity. 

NBIC is chartered to collect and consolidate near-real time information on biological events using in part, resources within the Federal Government and make those 

consolidated resources available to the Federal user community charged with meeting biological threats. 

We believe in this mission, and we look forward to working with DHS-NBIC 

again, and this time with far greater resources and capabilities. Veratect has offered 

to provide our analytical early warning system to NBIC and protect the United 

States from the threat of infectious disease, it should also be noted that this will 

also provide significant benefits to the rest of the world. Disease is the common 

enemy of every human on the planet. 

NBIC’s mission (as outlined in HSPD–7, –9, –10; NSPD–33; and Public Law 110– 

53), is a valid and critically needed function for both the United States and for the 

support of our international partners through the International Health Regulations, 

the World Animal Health Organization (OIE) Terrestrial Animal Health Code, the 

Biological Weapons Convention, and safety monitoring for biotechnology. 
27 

For the United States, a large number of biological crises and disasters are mostly 

imported events, as exemplified by the introductions of HIV/AIDS; West Nile virus; 

monkeypox; SARS and all four of the major influenza pandemics of the past 100 

years. Influenza pandemics are generally believed to start outside the United 

States; the next pandemic will most likely come from a foreign location. Our best 

defense is based on early detection. 

The current concern of an H5N1 influenza pandemic highlights this concern as 

well. As stated in the 2007 World Health Report, ‘‘It cannot be over-emphasized that 

a truly effective international preparedness and response coordination mechanism 

cannot be managed nationally. Global cooperation, collaboration, and investment are 

necessary to ensure a safer future. This means a multi-sectoral approach to managing the problem of global disease that includes governments, industry, public and 

private financiers, academia, international organizations and civil society, all of 

whom have responsibilities for building global public health security.’’ 

We can support the role of NBIC to protect our country by facilitating early recognition of biological events that may pose threats to our Nation’s security, food production systems, and citizens’ well being. The spirit of NBIC’s mission may be seen 

across other public emergency warning systems. As with those systems, a critical 

requirement for NBIC is reliance on detection subsystems that include not only the 

information they provide but the subject matter expertise behind it. 

Veratect is also able to support a turnkey portal for foreign and domestic biological event detection and tracking with extensive ground truth validation that can be 

shared with NBIC’s Federal, State and local partners. The benefits of immediate access to this portal will include access for CDC, USDA, FDA, DOD and other Federal 

partners who can then engage in more effective coordination of disease surveillance 

and response. 

By the nature of our business, we can assist NBIS by working in collaboration 

with other stakeholders in global health including transnational corporations, 

NGO’s and friendly foreign governments. U.S. corporations are increasingly concerned about how emerging diseases might affect their own employees and indigenous workers, production partners and supply chains. Foreign corporations operate 

in areas of interest to the United States and include oil, mining, manufacturing and 

food production. Their partnership is key to NBIC’s mission success. 

We are prepared to support NBIC’s implementation of its mission objectives by 

the end of August 2008. Our team and portal is available immediately and we stand 

ready to support a user community that is well known to us. 

There is an opportunity for the United States to lead the world by example once 

again. The United States has been the one to lead that development of many other 

societal warning systems over the years. Here we can be the leader in supporting 

implementation of the new International Health Regulations along with our international partners. We can demonstrate to the world our moral and ethical strength 

by assisting NGO’s in saving lives. We can support our domestic industry competing 

in the global marketplace. And most importantly, we can finally support our local 

city, county and State officials in biosurveillance. In the end, we are here to ensure 

the United States maintains technical supremacy in global biosurveillance in these 

uncertain times. 

I have three closing comments that speak to where we go from here: 

1. It is in the national and global interest for the NBIC charter to be implemented immediately. This envisioned system will help protect human, animal 

and plant life, the national food supply and critical infrastructure against the 

common enemy of disease. The first step is early detection. We are doing that 

today. 

2. Veratect provides a superset of capabilities, resources and global relationships with private and non-profit organizations that can be of the greatest value 

to NBIC in meeting its mission. What we do is not reliant upon the NBIC system. We can provide NBIC with a fully operational early disease detection and 

tracking system today. 

3. The disease risks are real and we are on borrowed time. We are fortunate 

that the SARS epidemic and this year’s H3N2 vaccine mismatch were not more 

disruptive. And we remain very much exposed to an influenza pandemic. My 

colleagues and I at Veratect are eager and ready to support the national mission today. 

I would like to thank the visionaries in the Federal Government and Congress 

who supported the research and development that led us to this point, the courageous men and women of the BIWAC for their partnership and the Veratect team 

for their hard work in operationalizing this critically important national asset. 

While none of us feel that we are, as a Nation, where we need to be in terms of 
28 

addressing the risks I have covered here today, I believe that Veratect can uniquely 

assist NBIC in rapidly achieving its goals. 

Once again, I am grateful for this opportunity to testify, and I stand ready to answer any questions you might have. 

Thank you. 

Mr. LANGEVIN. Thank you, Mr. Wilson. 

I want to thank all of the witnesses for their testimony, and I 

will remind each Member that they will have 5 minutes to question 

the panel. 

Now I recognize myself for questions. 

Before I do that, I am going to ask unanimous consent that the 

testimony for the record from Dr. David Hartley from the Global 

Argus Project be submitted for the record. 

Without objection, so ordered. 

[The statement of Dr. Hartley follows:] 

PREPARED STATEMENT OF DAVID HARTLEY

JULY 18, 2008 

Chairman Langevin, Ranking Member McCaul, and other Members of the subcommittee, please accept my thanks on behalf of the Global Argus team at Georgetown University Medical Center for this opportunity to update you on our work in 

the context of your hearing on the status of implementing bio-surveillance requirements of the 9/11 Act. 

Project Argus is a prototype bio-surveillance system pioneered at Georgetown University which was initiated in 2004 with funding support from the Intelligence Technology Innovation Center (ITIC) and is today supported by the Defense Threat Reduction Agency (DTRA) and the Open Source Center (OSC) of the Office of the Director of National Intelligence (ODNI). Argus is designed to detect and track foreign 

biological events that may threaten human, plant, and animal health globally and 

in the United States by monitoring social disruption evident in local, native-language media reports around the world. Because of our funding source, the data collection focuses on sources outside our country. 

By monitoring media sources—ranging from traditional print and electronic media 

outlets to internet-based newsletters in approximately 40 languages on every continent, save Antarctica—we have developed a solid prototype for gathering indications and warnings which serves an important cueing function. (A list of the languages covered by Argus as of last month is attached for your information.) It alerts 

users to events that may signal the initiation of outbreaks and show trajectories of 

events that may require additional investigation. To give you a sense of the kinds 

of reports that Argus generates, let me share two recent examples: 

• On June 13, 2008, Argus reported on a child in Vietnam hospitalized with respiratory distress following eating duck form the family’s farm. The illness was 

suggestive of H5N1 infection. The provision of this information by the CDC to 

the Vietnamese Ministry of Health proved to be very helpful to their epidemiology office. 

• On July 7—just last week—Argus alerted a Federal user about a suspected case 

of H5N1 avian influenza in Egypt. This user alerted an AI response team on 

the ground, which was otherwise unaware of the situation. 

Both of those instances and the manner in which they were handled recognize the 

fact that Argus cannot and does not purport to determine whether or what type of 

action should be taken. Instead, our activity serves to provide timely information 

to governmental officials to inform their decisionmaking. We are proud that Argus 

provides an important and unique data stream to the National Bio-surveillance Integration System (NBIS), complementing the reports of various Federal agencies 

with information gathered from open source media. We have been encouraged by 

the favorable comments from NBIS personnel about the value they find in the product generated by Argus. 

In developing the Argus prototype, Georgetown University researchers have developed a taxonomy of direct and indirect indicators of outbreak activity based on: 

• Environmental and ecological conditions; 

• Reports of disease activity; and, 

• Markers of social disruption such as school closings and infrastructure overloads. 
29 

Forty analysts fluent in the languages I referenced earlier are coupled with machine translation capabilities covering 13 languages to ensure a broad and deep 

scope to the media monitoring activities. Bayesian analysis tools are utilized for article selection and alerting. Approximately 1,000,000 articles are scanned daily with 

25 percent of those being archived. Since the inception of the program, the Argus 

archive has grown to over 128,000,000 articles. 

Over 40 Federal, State and local governmental entities use Argus on a daily basis 

including the Departments of Homeland Security, Health and Human Services, and 

State as well as the funding agencies. State and local governmental organizations 

in New York and Colorado as well as Colorado State, Kansas State, Syracuse, and 

Yale Universities are among the regular Argus Watchboard users. 

Global Argus underwent a change in leadership in April of this year. Such transitions certainly present challenges, but they also offer opportunities for strengthening projects such as this. I am pleased to be able to report that we have effectively 

managed the transition, including some personnel changes, without disrupting the 

quality or timeliness of the reports generated by Argus. In fact, since the change 

in leadership, Argus has increased the number of languages covered by qualified analysts and is in the process of adding even greater language capabilities. 

Having said that, working closely with the COTRs for the project, we are focusing 

on areas of focus designed to strengthen and perfect the prototype to ready it for 

eventual commercial utilization. I would emphasize that, while we are immensely 

proud of what has been achieved to date, we also share the interest of our current 

funding agencies in ensuring that Argus is fully ready to the task before it is scaled 

up. The areas on which we are actively engaged at present aim to validate 

taxonomies, methods and protocols including: 

• Reliable statistical characterization of Argus system performance; 

• Better documentation and validation of methodologies; and 

• Defining operational procedures set out in manuals both for the operational 

team and for various types of users. 

With Argus operational in its current configuration at Georgetown and with those 

validation and refinement efforts underway, I am confident that we, operating within an academic research institution with highly qualified scientific, medical and linguistic talent readily at hand, are ideally positioned to continue and broaden the 

project’s ability to generate accurate and timely reports while also conducting the 

validation and refinement work to ensure that the system is commensurate to the 

task which we all want to have achieved. We have had the depth of experience of 

developing Argus to its current stage and managing its operations to date, and we 

now have the benefit of a strengthened team of analysts to address the improvements sought by the Government agencies who have become particularly familiar 

with the system. 

On occasion, we have been asked about ‘‘next steps’’ for Argus, and the obvious 

need—beyond those referenced earlier—is to complement the international monitoring of these media-based indicators of social disruption with a similar capability 

domestically. As I referenced earlier, that is not possible given the current funding 

source, but, with appropriate funding, we stand ready to move on that front in a 

fashion that will benefit from the enhancements we are currently developing. 

ARGUS FOREIGN LANGUAGE COVERAGE—JUNE, 2008

Team Europe 

Albanian 

Bosnian 

Bulgarian 

Croatian 

Czech 

French 

German 

Greek 

Italian 

Macedonian 

Polish 

Portuguese 

Romanian 

Serbian 

Slovak 

Spanish 
30 

Team Central Asia 

Russian 

Ukrainian 

Belorussian 

Mongolian 

Georgian 

Uzbek 

Azeri 

Turkish 

Kyrgy 

Team East Asia 

Japanese 

Chinese (Mandarin and Cantonese) 

Korean 

Team Southeast Asia 

Thai 

Malay 

Vietnamese 

Indonesian 

Team Middle East 

Arabic 

Tajik 

Farsi 

Dari 

Team Latin America 

Spanish 

Portuguese 

Team Africa 

Berber 

Arabic 

French 

Mr. LANGEVIN. To Mr. Myers and Mr. Hooks, the 9/11 Act requires that the National Biosurveillance Integration Center, NBIC, 

under Section 316 of the Homeland Security Act be fully operational by not later than September 30, 2008. 

Again, from our meetings with NBIC’s staff, a fully functioning 

NBIC, including full participation by local authorities and private 

sector partners, are at least 2 years off. Is that accurate? Can you 

speak to how soon before it will be fully functional? It seems to us 

that right now really NBIC is running in a sort of test mode and 

is not really being used even by the perspective member agencies. 

So can you give us a current status of NBIC, most especially how 

far off are we before it is in fact going to be fully functional? What 

are the problems? What is standing in the way of us getting to the 

point where it is fully functioning? 

If we can start with Mr. Myers or Mr. Hooks. 

Mr. HOOKS. Thank you, Mr. Chairman. 

As you know, following the implementation of the 9/11 Act, 

which set clearly the vision and mission space forward for the 

NBIC, the NBIC started producing products last October into the 

interagency working group community. On 30 March of this year, 

we went live with the IT system, the NBIS 2.0, as well as the biological common operating picture, and at that point, we had an increased capability to share information in the interagency through 

that IT platform. 

From that time, we have been operational. When we talk about 

being in a fully operational state by 30 September, we have identi-
31 

fied, what are the different goals to reach that fully operational 

state? We have provided those seven different goals. 

But to summarize and highlight that, that means that we have 

the key personnel in place on the Federal staff as well as 10 

detailees on board from different interagency components; that we 

have the facilities in a condition that they are providing strong analytical support to our people; as well as an appropriate outyear 

funding profile for the NBIC operations, so it is very clear what the 

expectations and what are funding are as well. 

Within the IT system, we have been identifying the functionality 

goals, specifically additional capability within that system to be 

able to share information, to improve the analytics, as well as a 

system backup capability and a contingency operations plan. We 

are making updates to the biological common operating picture and 

are providing improved situational reporting to the different interagency members. 

Continuing on, in fact, with those goals, we are developing a 

more robust interagency community. We intend to have the memorandums of understanding in place, the interagency agreements in 

place for those detailees to strengthen. We will have held our NBIS 

interagency oversight council meeting this August, and we are on 

a path to have better cooperation and agreement with the government coordinating councils and sector coordinating councils that 

are run out of the Office of Infrastructure Protection. 

We also are strengthening the interagency collaboration; that is 

one of our goals, to be at full operational capability within DHS. 

We will have a 5-year strategic plan developed by that point. 

Those are our goals. There are huge challenges to reach those. 

The probably largest challenge is to create that trusted environment of information sharing within the Federal Government. In my 

previous position in Science and Technology Directorate, bringing 

together the 23 agencies to develop high-priority technology needs, 

I was able to do that in a 3-month period for the first draft of that 

and then ran that program for 2 years. That was easier than bringing the 12 member agencies together in a trusted information-sharing environment. We have seen that as a real challenge, but we 

have made progress as we have worked through the current tomato 

salmonella event that is ongoing. We will go into details of that as 

you would like. 

Mr. LANGEVIN. Let me stop you there, Because in your testimony, in your answer just now, you talked about having 10 

detailees by September 30. How exactly are you going to be able 

to accomplish that? Is that realistic, when I thought right now you 

only had one detailee from CDC? How realistic is bringing on the 

additional number and really completing that goal by September 

30? 

Mr. HOOKS. I think that is a realistic goal. Eric Myers and I have 

looked at that across the 12 member agencies and their commitment. On May 23, Secretary Chertoff issued a letter to his other 

Cabinet peers requesting they provide detailees to the NBIC operation. Eric has met with those different agencies. We have gauged 

the response from that. We are working the final efforts with some 

of those agencies now. In fact, recently one of the agencies said 

they wanted to bring over two of their stronger analytic people to 
32 

understand the NBIC operations so that they can work to understand what are the best complement of people in the long term. 

Mr. LANGEVIN. We are going to follow up on that and hopefully 

can hold you to it. 

Mr. Myers, since you are the program manager, would you comment on where we are? Do you have additional things to add to the 

testimony of Secretary Hooks? 

Mr. MYERS. Thank you, sir. 

Yes, just a couple of things to add to the spice. One is the sense 

that we are in fact operating. We sat down, using a previous study 

and also looking at the memberships. If you look at the 12 organizations, they are not only the traditional health and health-related 

organizations, but some that are not so related, Department of 

Commerce, Department of Transportation, Department of Interior, 

Postal System. So there are some very important partners in there 

who are trying to get into this culture. 

We in fact have been operating and in fact started to go back 

into operational production last October, as was mentioned. We 

brought in a new cadre of U.S. Public Health Service officers to actually man up our watch to give us 24-hour-a-day sight and vision. 

This is in the midst of going ahead with the execution on two 

planes: One is the building of it to get members. The Department 

of Agriculture in the first week of August will have two members 

on board with us, which is the next two detailees, and they actually 

come in to start work with us, in addition to doing a turnover in 

the first detailee from HHS, which is the individual from CDC. 

So, in addition to that, our interagency working group is a very 

vibrant group. There is a lot of analytic exchange. We do it on a 

daily basis. We formalize it in a routine production cycle. So that 

members, although they are not all signed on the dotted line on an 

MOU, are actually participating in any exchange. There has been 

very rigorous exchange on that. The salmonella and tomato risk 

happens to be one of those events. 

In addition to that, it is not just the inward look, and my second 

point to you, of the NBIC, in the NBIS, into the group that we have 

identified. Of particular importance in there is that each of the 

agencies comes to the table needing to support basically two cadres 

of customers. One is the decision-makers, sort of the policymakers. 

But the other is that we all have are operating components. So, for 

example, DHS has seven operating components. So our products 

are going to those. 

The other aspect that the NBIC brings that is very important is 

the taking of this health and health surveillance data that Dr. Wilson I think eloquently stated and superimposing that on top of how 

the Nation operates, the critical infrastructures. That becomes exceptionally important in terms of getting to early warning. It is not 

just the disease. It is not just a health issue. It is not just the population. But it is, what are the structures that that impacts, whether 

that be in food and agriculture, in health and finance, et cetera? 

Mr. LANGEVIN. So what operations by September 30 will the 

NBIC center be capable of carrying out? Let’s look at that. Then 

I am going to ask Mr. Jenkins to respond, if he would, to Mr. 

Hooks and Mr. Myers, to give your assessment in a point-counterpoint sort of way. Are they on track? Where are they perhaps being 
33 

overly optimistic? So if you can answer that question of the capabilities that are going to be capable to carry out. 

Mr. HOOKS. So the capabilities that we will be able to carry out 

by September 30 are to continue to monitor worldwide different 

biosurveillance activity, looking for cueing opportunities and forward-looking opportunities by integrating information from the different partner agencies that they are bringing into the NBIC team. 

We expect to be able to provide quality analytical capability back 

out to our partner agencies, who are also feeding that information 

down into the State and local network, so that we will have a common picture that is available for the interagency community in the 

biosurveillance arena. 

Mr. LANGEVIN. Mr. Jenkins or Mr. Myers, did you have anything 

to add for that? 

Mr. MYERS. No, sir. For the sake of time, that is good. 

Mr. LANGEVIN. Mr. Jenkins. 

Mr. JENKINS. Well, I think with regard to the interagency agreements and the detailees, it is not quite clear. The current MOUs 

were signed in January 2007. So between 2007 and now, there 

haven’t been any additional MOUs signed. So this is—either there 

is something breaking in the dam, or it is a fairly ambitious schedule in the sense that something is happening that will get these 

people to sign these agreement. But they also need to have these 

interagency agreements signed for those detailees, because that 

specifies whether or not they are going to be reimbursed, how they 

will come, what they will do, the staffing, the facilities. It is basically an operational agreement. The MOU is, ‘‘I agree to participate.’’ An interagency agreement is much more an operational 

agreement, which is a little more difficult to negotiate simply because it has more details that have to be structured. 

So I think, from our perspective, we wish them luck. I hope they 

are right. I hope they achieve it. But I think it may be a little bit 

optimistic. 

Mr. LANGEVIN. Thank you, gentlemen, for your testimony and for 

your answers. 

With that, I now recognize the Ranking Member for questions. 

Mr. MCCAUL. Thank you, Mr. Chairman. 

The Chairman brought up the point of the 9/11 Act being fully 

operational by September 30. It is not defined in the statute what 

‘‘fully operational’’ means. 

Mr. Hooks, what is your definition of ‘‘fully operational’’? 

Mr. HOOKS. Sir, my definition of ‘‘fully operational’’ are meeting 

the seven goals that we have laid out with the NBIC team and socialized into the interagency NBIC team to provide the capability 

necessary to conduct the mission as defined in the 9/11 Act. 

Mr. MCCAUL. Do you feel confident you will meet that by September 30? 

Mr. HOOKS. I feel confident that we can meet it if we can overcome some big challenges. I mentioned the one, which is the interagency cooperation in a trusted information-sharing environment. 

I would also like to mention that there is a reprogramming request on the Hill right now for $2.2 million. That needs to be approved for us to be able to bring the detailees on board to provide 

the IT—to improve the IT system to the capability that it needs to 
34 

reach, as well as to make some space fitout improvements so that 

we can improve that analytical capability. 

Mr. MCCAUL. So the interagency cooperation, which, granted, 

some of that is out of your control. 

Mr. HOOKS. Yes, sir. 

Mr. MCCAUL. And the appropriation you discussed. 

Mr. HOOKS. Yes, sir. 

Mr. MCCAUL. Mr. Jenkins, you referred to these MOUs that had 

been difficult to enter into. How many different agencies have now 

signed off on MOUs? 

Mr. JENKINS. Six out of 11. There are 12 agencies participating, 

which one is DHS. So the 6 of 11 have signed off on them. 

Mr. MCCAUL. What is the obstacle with the other five agencies? 

Mr. JENKINS. Well, part of it, as mentioned by Mr. Myers, is that 

they are nontraditional in the sense that they are nontraditional 

sort of public health agency kind of things. So that is part of it. I 

think the other thing is, in terms of that, for example, with regard 

to the Postal Service, the Postal Service is not normally in this 

kind of environment, although they clearly have a very keen interest in early biological detection. They are the only Federal agency 

that has actually lost people as a result of a biological event, the 

anthrax attack of 2001. At the end, as I said, across the areas that 

we look at in DHS, there is a real difficulty in getting agencies to 

sort of come to the table. 

There are concerns about privacy of data: Who controls the data? 

How will it get out? How will it be used? Who controls the use of 

it if there is a disagreement about something? As well as issues of, 

if there are disagreements, how will those be resolved? Those kinds 

of things tend to be the kinds of things that hold up these agreements, and they vary by different agencies as to what the specific 

issues are that are of concern to them. 

Mr. MCCAUL. Did I understand your testimony correctly that this 

is more voluntary? That there is no specific requirement that they 

sign these? 

Mr. JENKINS. That is correct. 

Mr. MCCAUL. So nothing in the 9/11 Act, no act of Congress has 

mandated that this happen? 

Mr. JENKINS. No. It is basically the ability to persuade, cajole, 

and negotiate. 

Mr. MCCAUL. Would it be helpful if Congress enacted more of a 

mandatory law? 

Mr. JENKINS. Perhaps it might be in the sense that it takes a 

long time. You can see how long it has taken here. There haven’t 

been any new agreements signed since January 2007. 

Mr. MCCAUL. Right. 

Mr. JENKINS. That has certainly affected NBIC’s ability to meet 

its operational goal. 

Mr. MCCAUL. This is an area where waiting can be lethal. 

Mr. JENKINS. Yes, sir. 

Mr. MCCAUL. With respect to the salmonella response, what was 

DHS’s role in that response? 

Mr. HOOKS. Our role within the salmonella response—I should 

first mention that our role is not to replace the Food and Drug Administration’s role in that mission space. They have the primary 
35 

authority for resolving that food contamination of that. But ours 

was initially to conduct the analysis, to understand the cascading 

effects of a food contamination event such as the salmonella event 

that we have seen. What are the economic impacts? What are the 

international ramifications? What other impacts can occur in the 

food sector, the public health sector that are not directly related to 

the salmonella event? Which is where FDA is working in that 

space. 

Additionally, because of the NBIC structure and people who are 

involved in that daily production cycle, as Eric Myers mentioned, 

we were able to provide the first interagency information on the 

probable source of the contamination independent of the FDA 

trace-back efforts and to be able to share that in the interagency. 

Our mission is to be looking forward in a cueing sense, whereas 

FDA is looking in a confirmatory role and will not share that information in an ongoing investigation. But yet, we need to be looking 

forward for the Federal Government to minimize the impact of 

these events, and we were able to do that. 

Additionally, we were able to bring other interagency members 

to the table, such as the Department of Defense, to help us better 

characterize the event. That is not a normal information flow that 

has been occurring. Additionally, we were able to bring State Department to the table in this NBIC construct to understand the implications if the source were with a foreign nation. We were able 

to bring specific information from Customs and Border Protection 

that is not normally brought into one of these food trace-back 

events, to be able to provide that to FDA to help them better characterize and improve their ability to do that. None of these efforts 

are replacing the effort of FDA; they are to augment and support. 

An additional area is in the private sector. With regulatory agencies, the private sector frequently will not share information or 

chooses not to. They were willing to bring that into the NBIC 

forum anonymously so that we could use that to help in the traceback. 

Mr. MCCAUL. So you got a real-life case test, if you will, into 

what kind of response you are capable of dealing with. Will there 

be some sort of after-action report or lessons learned from this 

event? 

Mr. HOOKS. Absolutely. That is our intent within the Department of Homeland Security. We have not broached that specifically 

with the Food and Drug Administration yet, but I think that will 

happen. 

Mr. MCCAUL. Thank you, Mr. Chairman. 

Mr. LANGEVIN. I thank the Ranking Member. 

The Chair will now recognize Members for questions they may 

wish to ask of the witnesses. According to the committee rules of 

practice, I will recognize Members who were present at the start 

of the hearing based on seniority, so next is Ms. Christensen from 

the Virgin Islands for 5 minutes. 

Mrs. CHRISTENSEN. Thank you, Mr. Chairman. 

Thank you for holding this hearing, and I am looking forward to 

the one in Rhode Island next week. 

I am going to ask a very basic question. First, you, Mr. Jenkins. 

We understand that you can’t fully comment on the report until 
36 

you have gone through the internal review process, but several 

questions have been asked and answered here that you are most 

likely to have first-hand knowledge because of your work on the report. So my very basic question: First of all, does NBIC represent 

a needed and necessary function to improve biosurveillance capabilities in the United States, or is it self-redundant, in your opinion? 

Mr. JENKINS. We are not in a position to say whether it is selfredundant or it isn’t based on the work that we have done. 

But I would say that, as Mr. Hooks has said, there is a real need 

in this international environment to have as early a warning system as you can that, and this is absolutely critical, but that it have 

data that is credible, reliable, and actionable. The sooner that you 

can have that data, the better off you are in terms of being able 

to reduce the impact of the event. You may not be able to prevent 

the event, but you could prevent the impact of it. 

So whether it is NBIC or some other mechanism, there certainly 

needs to be something that provides the data from a variety of 

sources. There is no single source of data in the Government or in 

the private sector that is really going to get you there. 

Mrs. CHRISTENSEN. Thank you. 

Either Mr. Myers or Mr. Hooks, one of the most important things 

in biosurveillance is rapid validation, of course, of the initial indicators and outbreaks, for example, environmental conditions. Some 

local indicators may point toward the emergence of a certain disease, but this must be verified. So what mechanisms, if any, are 

available to the NBIC to obtain the ground truth, to verify what 

you may pick up in the biosurveillance? 

Mr. MYERS. The process that we use is a very basic analytic process, which is to be in a constant screening mode and setting thresholds for the types of reporting that we want to do. So based on that, 

there is a constant screening review, a reach-out through the member agencies and an extensive network of data sources to be constantly canvassing. 

When there is an event that starts to cue up that is more important or starts to really grow to a larger threshold, let me use salmonella and tomatoes, where you are now having to have a significant impact, the first thing that we do is just to simply establish 

a subgroup or a subcommittee that is working in an analytic product, and we do that in 24-hour cycles. So we pack the cycles together, because the need for reporting and the need for information 

usually grows exponentially. With that, you start to refine who has 

what data and what gaps there are, and so that while you are 

working a production environment, you are simultaneously also 

trying to go after the data that you don’t have. You are trying to 

make that meet basically a 24-hour clock so that you are in a constant reporting. 

What does that is refine your effort, refine your conditions and 

allow you to start working early cueing while the science community is going through laboratory and laboratory results, and there 

is a necessary time and space that must take place to get those results to verify what you have. 

The marrying of this group of agencies and an NBIC, the importance is that you have a group and element in there that is the sci-
37 

entific community that wants to have positive results and proven 

results, and another aspect of that same group that realizes that 

there is a high demand for information sooner, sooner, and sooner. 

So when we talk about any kind of a culture clash, that is the one 

unified floor, area, region, virtually and literally, where you can 

have those discussions and put out your situation reports and the 

types of reports that leadership need on a continuing basis. 

Mrs. CHRISTENSEN. My time is almost running out. 

One of the concerns that the committee and the subcommittees 

have had is the turnover in personnel and also transitioning as we 

move to a new administration. 

I read recently that Dr. Runge is leaving. So are we anticipating 

that his leaving will impede the progress toward the NBIC becoming fully operational? Or are we deep and broad enough to sustain 

his leaving? 

Mr. HOOKS. Ma’am, I believe we are deep and broad enough to 

be able to sustain. The reason I believe that is this has significant 

interest by Secretary Chertoff right now as well, and he receives 

regular updates on the tomato salmonella event and what the 

NBIC is doing. He is committed to it. The Homeland Security 

Council is committed to improving the interagency sharing of information and creating that trusted environment. I am committed to 

that. Eric Myers has done a great job pushing that forward. So I 

think we have the team in place to be able to continue to push that 

vision forward effectively for the Nation. 

Mrs. CHRISTENSEN. Thank you, Mr. Chairman. 

Mr. LANGEVIN. Thank you. 

Mr. Wilson, did you want to respond to something that Mrs. 

Christensen had asked? 

Dr. WILSON. Yes, sir. Thank you very much. I appreciate that. 

The whole commentary about verification, that is a standard in 

outbreak detection and verification, and it was set by the World 

Health Organization and its partners about 10 years ago. 

I would just draw the subcommittee’s attention to the point that 

a lot of the points raised here today have been focused on domestic. 

We are heavily connected to the rest of the planet by the air traffic 

and commerce grid. Things come in here all the time. I have a wide 

variety of pathogens listed in my testimony, a quite astounding list, 

actually. Therefore, we have to monitor holistically. When we do 

that, we are getting, in a near real-time basis routinely, we are detecting things and vetting them with international partners on the 

ground as it happens. You can’t make a choice as to whether or not 

you are going to choose Federal capabilities or NGO or U.N. partners or what have you, because no single organization has ground 

verification capability that is that comprehensive. Obviously, that 

implies a whole range of information sources and credibility and so 

forth that has to be vetted by analysts, but therein is the challenge. 

Our ground verification network right now numbers 110,000 people globally. We need that kind of help for this mission. By the end 

of the year, we will definitely be pushing over a quarter million. 

This is unprecedented in history for this country and really for 

global health. So I would encourage the subcommittee to consider 

leveraging any and all available means to assist in that mission, 

because that step is critical to verification. 
38 

Mr. LANGEVIN. If I could, with the indulgence of the gentleman 

from New Jersey, I just wanted to follow up on something. 

As you know, Global Argus is a biosurveillance system that compiles open-source information on foreign disease outbreaks. An outgrowth of Global Argus is the Veratect system, which was spun off 

from Georgetown University as a private company. 

Can you explain the key differences between the two projects? 

Does the fact that Veratect is a private U.S. company remove the 

Title 50 problem associated with Global Argus? How would you 

compare the capability of Global Argus or the Veratect system to 

the current capability of NBIC? 

Dr. WILSON. Yes, sir. Thank you for the question. 

As the former principal investigator of Project Argus, now with 

the Veratect Corporation, we have the entire senior analytic pool 

from Global Argus now with our team at Veratect Corporation. 

Currently, the system that we are utilizing has 36,000 sources 

that we are utilizing compared to Global Argus’s approximate 

9,000. That gives us coverage of 86 percent of the world’s population through this medium. 

There are two key differences that I am going to highlight here 

in a second between Argus and the current capability now available at Veratect Corporation. One is that we could not do domestic, 

which is what you were implying with the Title 50 restrictions. We 

can now do that at Veratect. That was a critical gap, when we were 

tracking the H3N2 vaccine drifted strain from Asia and watched it 

spread throughout the world but we could not follow it as it entered there United States and, as we all have seen now, created 

quite a bit of problems for our influenza season last year. 

The second piece is, of course, as I mentioned before, the ground 

verification process, which is a critical step in our analysis. We 

must have that. We now have, as I mentioned before, we have 110 

people around the world now as partners to help verify these 

events. We were unable to do that at Argus. Again, as I mentioned, 

we do do domestic, and Argus is unable to do that. 

For biological agent tracking, my team and I, who are now at 

Veratect, we monitored about 60 pathogens in coordination with 

our Federal users. We have actually expanded this list now to 200 

pathogens that affect humans, humans and animals, and animals 

only. So we have a range actually of human health and agricultural 

issues, and we do cover food safety issues as well. 

We have research partners both in the national labs and 

transdisciplinary universities, so the bottom line here is, we started 

as a team designing a prototype, and now we have taken that to 

the next generation. We are now fully operational. 

This is truly a world-class capability that is going to continue to 

grow exponentially as we work with our partners around the world. 

Mr. LANGEVIN. I find that very interesting. We will be watching 

this closely as it unfolds. 

With that, the Chair now recognizes the gentleman from New 

Jersey, Mr. Pascrell, for 5 minutes. 

Mr. PASCRELL. Thank you, Mr. Chairman. 

Just to follow up, Mr. Wilson, if DHS had simply offered to fund 

Argus, would we have a domestic biosurveillance capability today? 
39 

Dr. WILSON. No, sir. The nature of the funding at Argus prevented us from doing domestic analysis. Currently, at the Veratect 

Corporation, the team that was at Argus that worked with me, the 

entire senior staff, along with myself, now at the Veratect Corporation, we are able to do foreign and domestic analysis. 

Mr. PASCRELL. Mr. Secretary Hooks, is it realistic to expect that 

the end game is to have sensors, biodetectors, as part of the surveillance systems in place throughout the United States of America? Is that the end game? 

Mr. HOOKS. I think the end game needs to be based on what the 

risk is to the Nation. 

Mr. PASCRELL. Well, what is the risk then, Mr.—— 

Mr. HOOKS. The risk is real for a biological attack or a naturally 

occurring biological event. 

Mr. PASCRELL. Then let me ask this question to Mr. Jenkins. 

Did you sense in the GAO’s review of the work, that you summarized—I just quickly read through your total report—do you sense 

a—and I know this is a judgment call—a sense of urgency in what 

you reviewed, in the people that are being held responsible for giving us a program here? 

Mr. JENKINS. I think they are very serious about it. 

Mr. PASCRELL. I didn’t ask you that question. 

Mr. JENKINS. What I am saying is, I think they do have a sense 

of urgency because they do believe that the threat is real and that 

we have to have some way of trying to deal with it. So I do think 

they have a sense of urgency. 

As I mentioned earlier, part of the problem in trying to get where 

we need to go is getting everybody fully on board and participating. 

Mr. PASCRELL. I understand that. But it is 16 months. For instance, as an example, to your own report, 16 months before we 

have had another agreement, a mutual agreement. For you to sit 

there and provide a review—I have a tremendous amount of faith 

in GAO, as you well know—and not to go to the very heart of this 

issue, it would seem to me that if we can’t get out of these eleven 

agencies some cooperation from five or six of them, there is a reason for that. 

We all know the reason, understand the reason. 

That doesn’t help us secure a surveillance system that we can 

feel confident in. So my question to you again is do you sense a realistic view of urgency here? 

Mr. JENKINS. Well, I think maybe I didn’t make myself clear. I 

was really referring to the NBIC folks as to whether or not they 

feel a sense of urgency. I think, in some cases, it seems relatively 

clear that other agencies who have been asked to participate, at 

least by their actions, don’t indicate that they feel a sense of urgency. 

Mr. PASCRELL. Well, one of the problems is, we had to wait until 

2007 to pass the 9/11 Commission Act and its recommendations. As 

you well know, one of the reasons, one of the main reasons why it 

took us so darn long is that the administration would not get out 

of our way. So we understand that this has been delayed down the 

road. 

Let me ask you this question, Secretary Hooks. You have to 

prioritize in the business of defending the Nation. You are never 
40 

going to have a seamless defense; we understand that, we all understand that. We are fallible human beings; I hope we all understand that. 

On a sense of priorities in terms of what you know and what we 

know and what those people who have inside intelligence about 

where we are in defending our neighbors and our children and our 

neighbors and the United States of America, where would you put 

a bioattack in regards to prioritizing what we need to be most prepared for at this moment in the history of mankind? 

Would you be concerned about, for instance, nuclear attack? 

Would you be concerned about the bioattacks, the very pathogens 

that you were talking about just a few moments ago? How would 

you prioritize it? 

Mr. HOOKS. I think that is a challenge obviously, integrating 

across the entire threat and risk space, considering the threat vulnerability and consequences. 

I believe in the time that I have been working in the Office of 

Health Affairs and the information that I have learned that a biological attack or a naturally occurring event is a higher priority 

than I think it has been viewed at within the country. 

Mr. PASCRELL. Yeah, I would tend to agree with you. 

But if that is the case, if that is the case and we are waiting 16 

months for the next mutual agreement, what does that tell you? 

How do you respond to that? 

Mr. HOOKS. The way I respond to that is, that is where my sense 

of urgency comes from and the people that are working on this 

issue. Within that sense of urgency, we have brought the other 

agencies to the table in discussion. We have not finalized some of 

those memorandums of understanding that have been identified by 

Mr. Jenkins. But I think we are making significant progress in creating interagency collaboration and information sharing. 

Mr. PASCRELL. You are waiting for a mere pittance, Mr. Chairman, relatively speaking—$2 million, $2.5 million you are waiting 

for. 

Mr. HOOKS. Two-point-two million, sir. 

Mr. PASCRELL. In this huge budget, and we can’t get out of our 

own way in order to provide these guys and gals with the amount 

of resources that they need to do the job. 

I would suggest to you, Mr. Chairman, that this is urgency by 

word and not by deed in this administration, and that we are at 

risk because of it—pure and simple. 

I have no further questions. Thank you. 

Mr. LANGEVIN. Well, I share the gentleman’s sense of urgency 

and frustration that we are not moving along, if it is a lack of resources; and both the administration and the Congress has to press 

this issue to make sure we get the right resources in the right 

place. I, for one, believe that a biological attack or the biological 

threats that we face, whether it is man-made or naturally occurring, are very serious, very real. 

The American people expect that we are going to get this right 

and we are going to protect the country. We are going to continue 

our rigorous oversight of this issue, and we will continue to partner 

with you in every way possible to make sure that we are closing 

the vulnerability of biological threats. 
41 

With that, I want to thank the witnesses for their testimony. 

There are votes on right now. So I am going to dismiss this panel. 

We have the BioWatch hearing coming up as the second hearing 

to this overall effort today. 

So, again, I want to thank the witnesses for their testimony. The 

Members of the subcommittee may have additional questions for 

the witnesses. We will ask that you respond expeditiously in writing to those questions. 

With that, this panel is adjourned. The subcommittee now stands 

in recess. 

[Recess.] 

Mr. LANGEVIN. The subcommittee will come to order. First of all, 

let me apologize for the delay. As you have learned, unfortunately, 

around here our lives are not our own, and that was the longest 

45 minutes I have ever had. I thought we would be done a lot 

quicker than that. Unfortunately, Members had other ideas. 

So I do want to thank the panel sincerely for waiting around. Obviously, this is a very important issue, and something I am anxious 

to get to. So without any further hesitation, let me convene our second panel on BioWatch. 

The first witness is Robert Hooks, who has testified on the first 

panel. Again we thank you for remaining for the second panel. 

The next witness is Dr. Jeffrey Stiefel, Director of the Early Detection Division, and Program Executive of BioWatch, Office of 

Weapons of Mass Destruction, WMD, and Biodefense at the Office 

of Health Affairs, Department of Homeland Security. Thank you for 

joining us. 

Remaining on the panel is William Jenkins of the GAO. We appreciate you, of course, remaining on the second panel to discuss 

BioWatch. 

Finally, we welcome Dr. Frances Downes, who is the Administrator of the State Public Health Laboratory at the Michigan Department of Community Health. Her lab is a member of the Laboratory Response Network and participates in the BioWatch program. 

Without objection, the witnesses’ full statements will be inserted 

in the record. Again, I want to thank all of our panelists today, and 

I want to now ask each witness to summarize his or her statement 

for 5 minutes, beginning with Mr. Hooks, who will read a joint 

statement for himself and Dr. Stiefel. 

Welcome. 

STATEMENT OF ROBERT HOOKS, DEPUTY ASSISTANT SECRETARY FOR WMD AND BIODEFENSE, OFFICE OF HEALTH 

AFFAIRS, DEPARTMENT OF HOMELAND SECURITY 

Mr. HOOKS. Thank you, Mr. Chairman and Representative 

Christensen. I appreciate your interest in biosurveillance programs 

and trust that my testimony today will provide valuable insight 

into the Department’s biosurveillance initiative to safeguard the 

Nation against a biological attack or other biological incidents that 

threaten the security of the homeland. 

The Nation continues to face the risk of a major biological event 

that could cause catastrophic loss of human life, severe economic 

damages, and significant harm to our Nation’s critical infrastruc-
42 

ture and key resources. Because of the challenges we face in assessing current terrorist capabilities and identifying plots, it is unlikely we will receive actionable, specific warning of an impending 

bioterrorist attack. Furthermore, many of these deadly biological 

agents are accessible in nature, relatively easy to procure, develop 

and transport without an advanced background in the biological 

sciences. Unlike nuclear weapons, few people with advanced laboratory knowledge in the biological sciences are needed to 

weaponize these deadly pathogens. As such, it is incredibly difficult 

to predict and prevent a biological attack from taking place. 

Biosurveillance includes many different components that work in 

complementary fashion to achieve a comprehensive awareness. 

This takes the form of both traditional and novel methods of early 

event detection, including environmental detection systems, clinical 

syndromic surveillance, reportable disease and laboratory base surveillance, monitoring of agriculture and wildlife activity, testing of 

the food supply, and monitoring mail and open-source analysis to 

name a few. Each is a necessary and valuable component of a comprehensive biosurveillance strategy. 

The BioWatch mission is to deploy and maintain a national 

24/7 early warning system capable of detecting the intentional release of select, aerosolized biological agents in order to speed response and recovery efforts, primarily focused on aerosolized anthrax. The purpose of this early detection and warning capability 

is to mitigate the consequences of a catastrophic attack which could 

affect tens of thousands of people if, for example, aerosolized anthrax were released. 

BioWatch is a part of a national biodefense strategy that includes 

intelligence, law enforcement, biomonitoring, situational awareness, decision support, response, and recovery activities. Within 

this strategy, BioWatch is an essential component of biomonitoring, 

along with astute clinicians, syndromic surveillance, food and agriculture monitoring, veterinary surveillance, and mail room monitoring. BioWatch is operating in over 30 of the Nation’s largest 

metropolitan areas, and consists of aerosol collectors, secondary 

sampling kits, laboratories, guidance documents, concepts of operations, communications protocols, an Internet-based information 

portal, subject matter experts, and a small number of early-generation indoor detectors. 

It is more than just detectors in the field. The BioWatch laboratories have been in continuous operation since 2003 and have analyzed more than 7 million samples without a single laboratory false 

positive result—an incredible feat. 

The BioWatch operational readiness is essential for the system 

to be effective. Representatives from the agencies, along with State 

and local public health and response personnel have created guidance documents for local jurisdictions to use in developing operational plans for BioWatch. These guidance documents cover preparedness response, environmental sampling, and indoor operations. 

The operational response plans for each jurisdiction are triggered 

by a BioWatch Actionable Result, and implemented by the local 

BioWatch Advisory Committee, or BAC. Investigations and discussions continue until consensus is reached about the significance of 
43 

the BioWatch Actionable Result, which is used to inform the protective action decisions on the part of the local public health officials. 

One of our highest priority initiatives is to replace collectors, the 

filters that require formal laboratory analysis, with automated detectors wherein the analysis is performed within the unit itself. 

The primary objective of the Generation 3 system is to introduce 

technological advancements that will significantly reduce the time 

to detect a biological agent from the current 10 to 34 hours down 

to between 4 and 6 hours, which will potentially save thousands of 

lives for each day an attack, such as anthrax, is detected ahead of 

human syndromic surveillance and other public health indicators. 

In conclusion, the challenge of detecting an invisible footprint of 

an impending bioterrorist plot and preventing an attack or the 

emergence of a pandemic is daunting. That is why DHS is taking 

the approach to enhance early detection systems and build a national biosurveillance capability for situational awareness. 

Thank you for the opportunity to testify. 

Mr. LANGEVIN. Thank you, Secretary Hooks. 

[The joint statement of Mr. Hooks, Mr. Myers and Dr. Stiefel appeared previously in this document.] 

Mr. LANGEVIN. I now turn to and recognize Mr. Jenkins to summarize his statement for 5 minutes. 

STATEMENT OF WILLIAM O. JENKINS, JR., DIRECTOR, HOMELAND SECURITY AND JUSTICE ISSUES, GOVERNMENT ACCOUNTABILITY OFFICE 

Mr. JENKINS. Thank you, Mr. Chairman, Ms. Christensen. 

The United States faces potentially dangerous biological threats 

that may occur naturally or as a result of a terrorist attack. Concern about the dispersal of lethal biological agents or widespread 

infectious disease outbreaks focused attention on the need for systems that can provide reliably accurate early detection and warning. 

BioWatch is intended to be such an early warning system. It deploys detectors to collect aerosol samples daily that are then analyzed to detect the presence of specific biological agents. The success of the program is dependent upon three things: accurate sampling, timely and accurate analysis that is actionable, and then actions based on that analysis. DHS has two ongoing efforts to improve the detection and analysis technology used by the BioWatch 

program, and the remainder of my statement today focuses on 

those issues alone. 

Currently, BioWatch detector samples must be manually collected, then transported to a lab for analysis, a process that can 

take, as Mr. Hooks said, from 10 to 34 hours. The manual collection and analysis inherently adds to the time it takes to identify 

the presence of the agents that are being monitored. 

BioWatch is developing two new types of detectors designed to 

reduce the time it takes to analyze samples. The first, Generation 

2.5, which is designed as an interim measure, would automate the 

analysis of samples, but detect and analyze the same agents that 

are now being monitored. The second generation, 3.0, would also be 

capable of automatic sample analysis, but in addition would even-
44 

tually have the capability to detect all biological agents on the 

threat list. 

According to DHS officials, the ability of the detectors to automatically analyze the samples they collect on a regular or prescribed schedule could reduce the elapsed time between air sampling and detection from 10 to 34 hours to 4 to 6 hours. In addition, 

the deployment of Generation 2.5 and 3.0 detectors would expand 

the use of the detectors in indoor environments. Current detectors 

focus on exterior sampling primarily. 

DHS officials say they plan to develop procedural guidance for 

responding to positive results from indoor detection by October 

2008 and apply it to all detectors employed indoors. Currently, 

there is no procedural guidance for responding to indoor detection 

of biological agents. 

DHS said that it plans to begin operational testing and evaluation of 2.5 Generation detectors in November 2008, and acquire 

about 100 of them if the testing is successful. Testing for Generation 3.0 detectors is scheduled for April 2009. 

DHS plans to replace all detectors with Generation 3.0 by 2013, 

with initial deployment beginning in 2010. In addition, the Gen 3.0 

detectors are expected to be less costly to both purchase and maintain than the 2.5 detectors—about 30,000 less to purchase, according to DHS, and 53,000 to 31,000 annually less to operate and 

maintain. 

That concludes my statement, Mr. Chairman, and I would be 

pleased to respond to questions you or other Members may have. 

Mr. LANGEVIN. Thank you, Mr. Jenkins. 

[The statement of Mr. Jenkins appeared previously in this document.] 

Mr. LANGEVIN. The Chair now recognizes Dr. Frances Downes for 

5 minutes. 

Welcome. 

STATEMENT OF FRANCES POUCH DOWNES, STATE PUBLIC 

HEALTH LABORATORY DIRECTOR, DEPARTMENT OF COMMUNITY HEALTH, STATE OF MICHIGAN 

Dr. DOWNES. Mr. Chairman and subcommittee Member 

Christensen, thank you for inviting me to testify today about the 

State and local government experience with the Department of 

Homeland Security’s BioWatch Program. As I was introduced, I am 

Dr. Frances Downes, Director of the Michigan Public Health Laboratories. 

State and local public health laboratories are an essential part 

of the Nation’s preparedness infrastructure. Michigan is one of 24 

public health labs that host the BioWatch program. I am also the 

current President of the Association of Public Health Laboratories, 

APHL, a national nonprofit that is dedicated to working with its 

members to strengthen governmental laboratories with a public 

health mandate. 

In March 2003, Michigan became a host laboratory for the 

BioWatch program. The security climate in the United States was 

very different than it is today. Public health labs had just come off 

the testing demands of the 2001 anthrax exposures. Biological 

weapon caches were still a purported threat. DHS contacted secu-
45 

rity officials in States with major urban centers and, together, determined that BioWatch testing would be a security asset. 

When we in the public health laboratory community were asked 

to install BioWatch testing programs, we did what we always do 

to meet the challenges to protect the public’s health. I was willing 

to take on the hosting program because it was clear that the response to a positive result would be primarily State and local. If 

I hosted testing, I could control the safety of the testing personnel 

and assure the quality of testing. Unfortunately, we have never hit 

this mark, and we are moving farther away from it. 

At that time, verbal promises were made regarding support for 

the program. Did we get those promises in writing? No. 

We are not contractors or vendors. Public health functions in a 

culture of partnership. Public health laboratories are part of a system that, for over a century, has been committed to providing services in the interests of our public health communities. 

BioWatch space demands have grown at an unrestricted pace. 

The image you see on the monitors indicates the initial footprint 

of the BioWatch program in Michigan in 2003. The red space is exclusively for BioWatch use, and it cannot be used for public health 

priorities. The yellow space is shared between BioWatch and Michigan testing. 

This next image shows the BioWatch footprint in 2008. You can 

see the significant growth in space that is utilized by BioWatch. 

These images are just from the first floor of the Michigan laboratory, but they are followed by images on the second floor over the 

same period. More equipment, dedicated sample receipt areas, 

servers, supply storage, the demands are limitless. 

I have also brought along some photos that show how much of 

our space is used to store BioWatch supplies, equipment, and other 

material. All the items displayed in these photos are only for 

BioWatch use. 

I would also like to briefly give voice to some of our major concerns about BioWatch that we have included in our correspondence 

to you. 

DHS and its BioWatch contractor have no written agreement 

with, or contractual relationship, legal authority, regulatory or otherwise, with State and local public health labs, yet DHS is contractually obligated to their contractor to provide laboratory space. Because there is no agreement of any sort between public health labs 

and DHS or their contractors, there is no ability to require adherence to standard operating procedures and policies, even those related to laboratory safety. 

DHS has distributed a draft memorandum of agreement to address this matter, but it is unlikely that the State and local governments will enter into an agreement soon. For starters, DHS has 

said they will not reimburse the use of laboratory space and storage space, an issue they say is nonnegotiable. 

State and local public health labs have not received funding from 

DHS to support the expanding cost of testing programs, but other 

State agencies collecting the samples and transporting them to our 

laboratories daily are reimbursed for their expenses. To be blunt, 

this amounts to nothing less than a Federal Government demanding a match from State and local government to defray the cost of 
46 

a Federal program with no limits, no control on the direction of the 

program, but almost total responsibility for response. The lab absorbs the cost, including lab space with utilities, and removal of infectious waste materials, support services, training, IT infrastructure, telephones, cell phones, vaccinations, on-site scientific direction, and expertise. 

The draft MOU, in fact, would increase the cost on labs by requiring them to pay for maintaining certification on lab equipment 

and information technology, costs currently covered by DHS. With 

State and Federal preparedness budgets shrinking at the same 

time, the burden of the costs incurred for hosting BioWatch will 

reach a critical mass in the near future. Although the lack of any 

written or contractual relationship or legal authority precludes 

BioWatch from being considered an unfunded Federal mandate, its 

effect on State and local obligations is the same. 

Prior to January 2008, when a new contract was awarded, State 

and local labs were able to provide input on personnel matters, including having the final say on job offers, contributing to performance evaluations. Under the proposed MOA, these oversight roles 

are lost. Public health labs have other contract employees and Federal assignees working in our facilities and provide oversight without interfering with those employer rights and responsibilities. 

The draft MOU provisions on cross-training BioWatch contract 

personnel to perform other preparedness and public health emergency testing is overly restrictive. Those provisions greatly reduce 

the ability of having BioWatch contract personnel trained for public 

health emergencies, such as the ongoing Nation-wide salmonella 

outbreak or helping out with testing related to the Midwest floods. 

The State and local public health laboratories would prefer to 

work with the BioWatch program in a more constructive and direct 

manner, and my written testimony has several recommendations 

for DHS to consider. With funding and increased management 

oversight, public health lab directors would be able to improve 

work flow, promote cross-training among laboratorians to increase 

testing capacity for public health emergencies, and improve laboratory quality in BioWatch locations. 

The BioWatch program has been variously described by my fellow State and local lab directors as a ‘‘parasite’’ to the public health 

laboratory and ‘‘squatters’’ in valuable laboratory space. I am hard 

pressed to disagree. 

This concludes my testimony. Thank you again for inviting me 

to participate in this hearing. 

[The statement of Dr. Downes follows:] 

PREPARED STATEMENT OF FRANCES POUCH DOWNES

JULY 16, 2008 

Mr. Chairman and Members of the subcommittee: Thank you for inviting me to 

testify about the State and local government experience with the Department of 

Homeland Security’s BioWatch program. I am Dr. Frances Pouch Downes, the director of the State of Michigan public health laboratory—in the Michigan Department 

of Community Health. State and local public health laboratories are an essential infrastructure program that support testing for public health programs and serve as 

the reference laboratory to hospital and clinical laboratories Nation-wide. Michigan 

is one of 24 public health laboratories that host the BioWatch program. I am also 

the current President of the Association of Public Health Laboratories (APHL). 
47 

APHL is a national non-profit located in Silver Spring, Maryland, that is dedicated 

to working with its members to strengthen governmental laboratories with a public 

health mandate. By promoting effective programs and public policy, APHL strives 

to provide public health laboratories with the resources and infrastructure need to 

protect the health of U.S. residents and to prevent and control disease globally. 

In March 2003, the Michigan Bureau of Laboratories became a host laboratory for 

the BioWatch program. The security climate in the United States was very different 

than it is today. Public health labs had just come off the intensive testing demands 

of the 2001 intentional anthrax exposures. Biological weapons caches were still a 

purported threat. DHS contacted State security officials in States with major urban 

centers and determined that the BioWatch testing program would be a security 

asset. When the public health laboratories were asked to install the BioWatch testing program, we did what we always do: Meet the challenges to protect the public’s 

health, which in this instance meant devoting considerable resources to receiving 

and installing equipment and supplies, being trained, training the contractors who 

would perform the testing and participating in the development of response plans. 

The response plans made it clear that I would be responsible for result interpretation and initiating the cascade of events that ensue after a positive result. Therefore, I was willing to take on the burden of hosting the program, if I could control 

the safety of the testing personnel and assure quality of testing. I accepted the program with the caveats that the program did not divert us from other essential public health testing priorities and I controlled quality and safety of the testing program. Unfortunately, we have never hit this mark and are moving further away 

from it. 

At that time verbal promises were made regarding support for hosting the program. Did we get these promises in writing? No. We are not contractors or vendors. 

We function in a culture of partnership. Public health laboratories are part of a system that for over a century has been committed to providing the services in the interest of the health of our communities. 

The technology and the mechanisms for acquiring testing personnel have evolved 

since the inception of the BioWatch program but the contribution of the host laboratories has never been considered by DHS nor have the safety and quality responsibilities of the host laboratory. 

First, space demands have grown at an unrestricted pace. The image you see on 

the monitors indicates the initial footprint of the BioWatch program in the Michigan 

lab in 2003. The red space is exclusively for BioWatch use and cannot be used for 

Michigan public health testing priorities; the yellow space is shared between 

BioWatch and Michigan public health testing. This next image shows the BioWatch 

footprint in 2008 and you can see the significant growth in the red space that is 

dedicated to BioWatch. These images from the first floor of the Michigan laboratory 

are followed by images that display the growth on the second floor over the same 

period of time. More equipment, dedicated sample receipt area, server, and supplies. 

The demands are limitless. 

[The images follow:] 
48 

To give you a better visual perspective of the impact BioWatch has had on the 

Michigan laboratory, I’ve also brought along some pictures that show how much of 

our space is used to store BioWatch supplies, equipment and other materials. All 

of the items displayed in these pictures are only for use in the BioWatch program. 

None of these pictures show the actual equipment used to perform testing on 

BioWatch samples or the space that equipment occupies. 
49 

[The images follow:] 
50 
51 

Mr. Chairman, APHL has provided you with correspondence that details the significant concerns related to the BioWatch program and its presence in public health 

laboratories. I would like to briefly give voice to some of our major concerns: • No agreed-upon roles and responsibilities between DHS, its contractor and Public Health Laboratories.—At present, DHS and its BioWatch contractor have no 

contractual relationship or legal authority, regulatory or otherwise, with State 

and local public health laboratories for the operations of the BioWatch program. 

Yet, DHS is contractually obligated to the BioWatch contractor to provide laboratory space (Section 4.1 of Task Order No. HSHQDC–08–F–00016). 

Because there is no agreement of any sort between the State and local public 

health laboratory and DHS or BioWatch contractor, there is no ability to require 

adherence to site specific quality assurance practices, standard operating procedures and policies—even those that relate to laboratory safety. Furthermore the 

absence of any agreement has spurred State and local government legal offices 

into action because of their concern over the exposure to these governments, including unresolved liability and worker’s compensation issues. 

DHS has distributed a draft Memorandum of Agreement (MOA) to address 

this matter, but the details included in the draft make it unlikely that State 

and local governments will enter into an agreement soon. For starters, DHS has 

said they will not reimburse for the use of laboratory and storage space—an 

issue they say is non-negotiable. Again, the draft MOA does not limit the space 

and administrative demands that the BioWatch program can place on a laboratory. Also, while DHS proposes one MOA that will be utilized nationally, the 

unique legal issues in each State and local government must be recognized and 

they demand individual resolution. 

• Uncompensated Laboratory Costs.—State and local public health laboratories 

have not received funding from DHS to support the cost of housing and overseeing the BioWatch program whereas the State agencies collecting the samples 

and transporting to the public health laboratories daily are reimbursed for their 

expense. I have already mentioned the key non-negotiable element of reimbursement as it relates to the draft MOA. The message transmitting that draft 

MOA asserts: ‘‘DHS cannot enter into an arrangement to reimburse for space, 

due in part to funding limitations, and in large part to the Anti-deficiency Act, 

which precludes long term commitments without sufficient funds appropriated.’’ 

To be blunt, this amounts to nothing less than the Federal Government demanding a match from State and local governments to defray the expenses of 

a Federal program with no limits, no control on the direction of the program 
52 

but almost total responsibility for response. The State and local public health 

laboratories absorb costs associated with administration, training, and safety for 

BioWatch-contracted personnel. These costs include laboratory space with utilities, removal of infectious waste material, support services, training, computers, 

telephones and cell phones, vaccinations, and on-site scientific direction and expertise on questionable results. As I’ve shown you, the BioWatch footprint continues to expand in the host laboratories, often taking up extensive space in 

multiple rooms. 

For example, in one public health laboratory, the BioWatch program occupies 

975 square feet of laboratory space in 8 rooms on 4 floors. In addition to the 

costs of providing space and administrative oversight, laboratories may need 

testing personnel to maintain daily testing or to support intensive testing that 

occurs during high profile special events (like political party conventions, sporting events). Two public health laboratories only have one BioWatch-contracted 

employee and must use State laboratory employees to complete BioWatch testing despite informing DHS of this work force shortage over a year ago. In plans 

to prepare for intensive testing or contract employee vacancy, the BioWatch contractor is to establish a contract and pay State employees to provide additional 

testing capacity. However, the contractor has been slow to sign, or has not 

signed these State employees on. Also, the contractor is on record of approving 

an insufficient amount of time for training and other quality assurance activities that will prepare the State employees for the situation when they are needed. Finally, these employees may not be available in the event of a bioterrorism 

emergency and great testing demand because their primary responsibility is to 

fulfill their role to the Laboratory Response Network (LRN). As the primary and 

career employer, the State laboratory director will determine the individuals assignment; not a contractor. 

Further, the draft MOA would require that the State and local laboratories 

pay for the cost of maintaining certification on laboratory equipment used in 

BioWatch testing—costs that were previously covered by DHS. 

Most alarming is the situation in one State where the current BioWatch contractor has been very reluctant to address any of the problems related to the 

daily operation of the BioWatch laboratory. When the new contract was awarded, payment for the internet connection service used by the BioWatch program 

was terminated. When the new contractor was informed of this problem, they 

suggested that the State laboratory pay for the service—an option the laboratory declined. This problem has yet to be resolved. With State and Federal preparedness budgets shrinking at the same time, the burden of the costs incurred 

for hosting BioWatch will reach critical mass in the near future. 

Although the lack of any contractual relationship or legal authority precludes 

BioWatch from being considered an unfunded Federal mandate, its effect on 

State and local obligations is the same. 

• Management and Oversight of Contract Employees at the Local Level.—In January 2008, DHS awarded the BioWatch staffing contract. In May 2008, public 

health laboratories hosting the BioWatch program received a communication 

from DHS (attached) explaining that the non-personal services nature of the 

BioWatch contract greatly restricts the roles of DHS and the public health laboratories in the management of the BioWatch-contracted personnel. I would call 

attention to this portion of the DHS explanation which compounds the challenges for State and local public health laboratories hosting the BioWatch program: ‘‘The current contract that the Department of Homeland Security (DHS) 

has with A-TEK, Inc. is a nonpersonal services contract. The following definition of a nonpersonal services contract comes from the FAR, Part 37.101: ‘ ‘‘Nonpersonal services contract’’ means a contract under which the personnel rendering the services are not subject, either by the contract’s terms or by the manner of its administration, to the supervision and control usually prevailing in relationships between the Government and its employees.’ ’’ (Emphasis added.) 

The host laboratories are neither Federal Government nor employees of the 

Federal Government. 

Since the transition of BioWatch-contracted personnel to the new contractor, 

public health laboratory directors have struggled to maintain open lines of communications with the contractor, BioWatch-contracted personnel located in our 

labs and DHS. Communication has been constrained by contractor-issued directives that prohibit BioWatch-contracted personnel and supervisors from fully 

communicating with their public health laboratory counterparts and fail to understand how fully integrated BioWatch operations and personnel are with public health laboratory operations and employees. 
53 

Contract employees are instructed to contact the contractor in the event of 

quality control failures or positive results. There is no reason for this communication to occur since the contractor is not involved in response and CDC provides quality assurance consultation. It is imperative that lines of communication are seamless and totally unrestrained to assure the most efficient and effective laboratory operations. The advice and direction by the contractor will 

only confuse the response and is not welcome nor needed. 

Prior to the issuance of the January 2008 BioWatch contract, the State and 

local laboratories were able to create salary parity between the BioWatch-contracted personnel and State laboratory employees based on prevailing local compensation; and they were able to have the final say on which interviewees received job offers, contribute to performance evaluations, and determine disciplinary actions to be taken by the contractor. Under the proposed MOA described 

previously, these oversight roles are lost. In fact the current contractor instructs 

their employees not to communicate with host laboratory personnel on many 

issues including wages. Public health labs have other contract employees and 

Federal assignees working in our facilities and provide oversight without interfering with employer rights and responsibilities. It is only this contract that has 

put us at odds with the contractor. 

Public health laboratory directors are legally responsible under State and 

Federal law for the safety of all activities that occur within their laboratory, including all who work within their laboratory. This includes determinations on 

who has access to and is working in the laboratory (laboratory security), what 

analytical procedures are undertaken and how they are performed (laboratory 

safety and practice), and fair and equitable treatment and supervision among 

all laboratory staff (laboratory operations and employee morale), among others. 

BioWatch needs to run in parallel to the existing State and local public health 

laboratory infrastructure and it must not undermine that infrastructure with 

determinations on the internal operations of these laboratories, like whether the 

BioWatch-contracted personnel should be registered in the CDC’s Select Agent 

program. The work location alone suggests Select Agent registration. • Science and Technology.—To date, State and local public health laboratory directors have not been provided with the performance data (sensitivity, specificity, limits of detection) that are necessary for them to make the best judgment possible on any BioWatch Actionable Result (or BAR). In addition, many 

of these laboratories have expressed interest in providing input into the evaluation and implementation of new technologies as this has a direct impact on the 

use of laboratory space, personnel, and utilities as well as BAR response. New 

technologies have simply been foisted upon the laboratory without adequate 

preparation, including the performance data referenced above. Additionally, 

some public health laboratory scientists are concerned that there may be naturally occurring background levels of some pathogens in surveyed cities, such as 

Francisella tularensis in Houston, Texas, leading to positive findings in the 

BioWatch program which do not result from bioterrorism. Other than descriptive data from studies conducted in Houston, and Virginia, public health laboratories have not been privy to data depicting the background levels and types 

of organisms in the environment. 

• Other Issues.—In the draft MOA, DHS continues the practice of asserting that 

BioWatch-contracted personnel do not have to go through the Department of 

Justice’s Security Risk Assessment (SRA) clearance process. The SRA is required for any individuals who may have access to select biological agents and 

toxins. This is in direct conflict to the statement in the draft MOA that the contract employees may spend up to 25 percent of their time working on Category 

A and B agent testing. The biological select agents are all included in Category 

A. Due to the space demands of the BioWatch program, contract employees may 

be working in areas that provide them access to select agents. The draft MOA 

provisions on cross-training that restrict BioWatch-contracted personnel to only 

perform testing on environmental samples and not work on clinical specimens 

is overly restrictive. This greatly reduces the utility of having BioWatch-contracted personnel cross-trained for public health emergencies, such as the ongoing Nation-wide Salmonella outbreak. 

State and local public health laboratories work closely with the CDC’s Laboratory 

Response Network (LRN) to provide analytical support for the BioWatch program. 

Many of these laboratories have limited interactions with DHS. The public health 

laboratory personnel who perform LRN testing also would perform follow-up or 

Phase 1 Response testing on a BAR. It is important for both the staff of the public 

health laboratory and any BioWatch-contracted personnel to work closely together 

and fully understand all testing procedures. 
54 

The State and local public health laboratories would prefer to work with the 

BioWatch program in a more constructive and direct manner and recommend that 

DHS consider the following options for the BioWatch program: 

I. Fund State and local public health laboratories through a DHS cooperative 

agreement mechanism to manage the BioWatch program. This mechanism could 

either be with APHL or directly with the jurisdictions. With direct funding to 

the State and local jurisdictions, the BioWatch-contracted personnel would become employees of the State or local laboratory and can be easily cross-trained 

and integrated into the public health laboratory. This would allow the public 

health laboratory director to fulfill their responsibilities to their jurisdictions 

(and comply with all applicable Federal and State regulations pertaining to the 

laboratory). A cooperative agreement would allow for significant programmatic 

involvement by DHS and collaboration by the public health laboratory. 

II. Provide funding to States to via the CDC Public Health Emergency Preparedness (PHEP) Cooperative Agreement—it is important to note that PHEP 

Cooperative Agreement funds are shrinking and State and local public health 

laboratories cannot take on additional activities, such as BioWatch without an 

adequate investment from DHS. Using the PHEP Cooperative Agreement mechanism, a designated sum of money can be set aside for each BioWatch host laboratory. 

III. Remove the limitation on the ability of State and local public health laboratories to cross-train BioWatch-contracted personnel that limits them to testing 

environmental samples. Cross-training of BioWatch-contracted personnel should 

be more broadly applied to testing clinical specimens and environmental samples of public health significance, such as the work done under the CDC Public 

Health Emergency Preparedness cooperative agreements. This would allow for 

more effective and robust testing capacity in a surge situation and would increase employee morale as they would be integrated into the laboratory operations. 

IV. Investigate the use of contractor incentives to foster integrated management 

of BioWatch-contracted personnel. 

V. Until such time when an improved mechanism is in place, DHS must work 

directly with State and local public health laboratories and other vested partners to ensure that BioWatch-contracted personnel applicants and hires: (a) 

Meet minimum hiring qualifications equivalent to public health laboratorians 

performing the same work; (b) accept the hiring recommendation of the public 

health laboratory director or designee; (c) can interact effectively and productively with the public health laboratory staff; (d) are subject to public health 

laboratory policies and procedures, and (5) abide by all public health laboratory 

safety and security rules and policies. Further, DHS should require the 

BioWatch contractor to consult with the public health laboratory director when 

evaluating BioWatch-contracted personnel so that the public health laboratory 

directors can provide input into employees’ evaluations with respect to laboratory productivity, safety, and security, and interaction with co-workers. 

APHL members and staff met with the senior DHS BioWatch leadership in the 

Office of Health Affairs on November 19, 2007, to ensure they understood the role 

of State and local public health laboratories and APHL in homeland, including 

BioWatch and need for continued and enhanced communications. Once the 

BioWatch contract was awarded, APHL sent the attached January 17, 2008 letter 

to Dr. Runge outlining concerns about a number of personnel matters that developed with the award of the new contract and suggesting options for improvements. 

No reply has been received to this letter as of today’s date. 

Additionally, the association has documented our communication to DHS regarding the public health laboratory community’s interest on communicating its recommendations concerning BioWatch. The process of developing memoranda of 

agreement with the public health laboratories may ultimately address these concerns; however because of the urgent need for some immediate solutions an interim 

approach is also needed. 

APHL works to safeguard the public’s health by strengthening public health laboratories in the United States and globally. We advance laboratory systems and 

practices, and promote policies that support healthy communities. APHL and its 

State and local public health laboratory membership are committed to working with 

DHS to assure that laboratories are adequately funded to support the BioWatch program and to improve the overall management of BioWatch-contracted personnel. 

With funding and increased management oversight, public health laboratory directors would be able to improve workflow, promote cross-training among 

laboratorians to adequately utilize staff and improve quality laboratory practices by 

implementing standard quality control measures in all BioWatch locations. 
55 

The BioWatch program has been variously described by my fellow State and local 

laboratory directors as a parasite to the public health laboratory and squatters in 

valuable public health laboratory space. I am hard-pressed to disagree. 

This concludes my testimony, and I thank you again for inviting me to participate 

in this hearing. 

ATTACHMENT 1.—FAR 37 PERSONAL SERVICES CONTRACTS EXPLANATION 

Federal Government agencies are required to adhere to Federal Acquisition Regulations (FAR) when purchasing goods or services. FAR Part 37 is the section that 

addresses ‘‘Service Contracting.’’ 

A service contract may be either a nonpersonal or personal services contract. 

The current contract that the Department of Homeland Security (DHS) has with 

A-TEK, Inc. is a nonpersonal services contract. The following definition of a nonpersonal services contract comes from the FAR, Part 37.101: ‘‘ ‘Nonpersonal services 

contract’ means a contract under which the personnel rendering the services are not 

subject, either by the contract’s terms or by the manner of its administration, to the 

supervision and control usually prevailing in relationships between the Government 

and its employees.’’ 

For reference, the definition of a personal services contract, as written in FAR 

Part 37.104, is as follows: ‘‘A personal services contract is characterized by the employer-employee relationship it creates between the Government and the contractor’s personnel. The Government is normally required to obtain its employees by direct hire under competitive appointment or other procedures required by the civil 

service laws. Obtaining personal services by contract, rather than by direct hire, circumvents those laws unless Congress has specifically authorized acquisition of the 

services by contract.’’ Here, the ‘‘Government’’ refers to DHS and not the local or 

State laboratory directors or their designees. The services acquired in this case do 

not constitute personal services because Congress has not specifically authorized the 

acquisition of personal services by contract. 

Furthermore, Part 37.104 states that [Federal] ‘‘Agencies shall not award personal 

services contracts unless specifically authorized by statute to do so.’’ DHS has no 

authorization for a personal services contract to support the BioWatch Program. 

Since the DHS contract with A-TEK, Inc. (for the BioWatch Program) is a nonpersonal services contract, the following actions are prohibited: 

• Personnel hiring/firing actions.—The Laboratory Directors (or their designees) 

cannot hire or fire a Contractor’s employees. The Contractor is responsible for 

these employment actions, as these employees are their personnel. If there are 

any issues with Contractor employee conduct while hosted at the laboratory’s 

facility, it is incumbent upon the Laboratory Director (or their designee) to inform DHS of these issues. 

• Contractor internal matters.—The Laboratory Directors (or their designees) cannot interfere with a Contractor’s internal matters (i.e., employee benefits, salaries, timesheet authorization, etc.), particularly those associated with the Contractor laboratory personnel. Under FAR regulations, DHS is also prohibited 

from interfering with Contractor internal matters. 

• Contractor operations.—The Laboratory Directors (or their designees) cannot 

dictate to the Contractor how the Contractor should operate. Under FAR regulations, DHS is also prohibited from dictating Contractor operations. 

Other matters: 

• Contract labor issues.—The Laboratory Directors (or their designees) cannot attempt to solve, or engender labor irregularities. DHS’ role is that of an impartial observer. 

• Contractor work efforts.—The Laboratory Directors (or their designees) cannot 

delay, or cause to be delayed, the Contractor’s work processes. Under FAR regulations, DHS is also prohibited from delaying the Contractor’s work processes. 

• Contractor personnel behavior issues.—In the event contractor personnel behavior constitutes an immediate danger to themselves, other personnel, or facilities, 

or create a workplace environment that is hostile (harassment) the Laboratory 

Director may take such actions as necessary to mitigate the risk, with subsequent notification to the contractor and DHS. The contractor will then conduct 

an investigation on the incident(s) and take such action as necessary. 

Other notes: Justification for DHS obtaining a laboratory personnel services contract. DHS has a requirement for laboratory operations (including personnel) to ensure daily sample analysis is performed for the BioWatch Program. The performance of this work includes the operation of Government-owned equipment and systems. 
56 

Mr. LANGEVIN. Thank you, Dr. Downes, for your testimony. 

I want to thank all the witnesses for their testimony. I remind 

Members that he or she will have 5 minutes to question the panel. 

Before I go to questions, I just want to make reference to the fact 

that my partner in this effort, the Ranking Member of the subcommittee, Mr. McCaul, unfortunately, due to the late hour that 

we returned, has a conflict with another meeting, and will not be 

able to return, but asked that we continue in his absence. 

Let me begin with Mr. Hooks. This isn’t the question I had intended to ask, but given Dr. Downes’ testimony, it doesn’t sound 

like BioWatch is being a very good partner in this case with the 

State and locals. Would you please respond to the testimony? How, 

if in this case the Michigan Department of Community Health in 

this case is not having a good experience, how are we going to expect other States and localities to want to participate if this is the 

way a, quote-unquote, partnership is working? 

Please respond. 

Mr. HOOKS. Yes, Mr. Chairman. 

I point to some of Dr. Downes’ testimony where she talked about 

a culture of partnership. I heartily agree that that is what the 

BioWatch program needs to be. It is a Federal-State-local partnership, including the local laboratories. 

I am disappointed to be hearing the comments that she has provided. I am disappointed that I wasn’t aware of the level of concern 

in the laboratory community since I have taken over this program. 

I am committed to resolving that. 

I have already offered to go visit with her and other appropriate 

officials to ensure that we create that level of partnership because 

I think, ultimately, our goal is the same, that we want to provide 

an early detection capability for the Nation that benefits the Nation. 

This isn’t an issue of BioWatch, national program office, against 

the State, local community; and we need to look to create a value 

proposition that benefits both of our needs and our constraints. 

Mr. LANGEVIN. Mr. Hooks, I know that you are relatively new in 

your current position, so I do want to turn to Dr. Stiefel as the program manager for BioWatch. 

Have you heard the concerns that Dr. Downes has raised, or is 

this news to you? 

Dr. STIEFEL. No, no, not at all, sir. There have been concerns. 

One of the issues is, we just changed contractors. Whenever you 

change a contractor, there is always the—there is always turbulence when that occurs. We have heard about this. We have actually been taking actions with the contractor to try to ensure that 

the contractor performs up to the standards, talks to the lab directors about what has to happen. 

There are certain issues, because it is a contract, that are contractor employee-based, and as such, a contractor has to hire and 

fire the employee. But that is done and should be done through the 

lab director’s advice and guidance. That is what we are trying to 

ensure. That is the way it was done over the previous contractor, 

when those employees converted from a CDC term hire to a contract. So these aren’t new issues in the sense that we have been 

addressing them through the contractor. 
57 

We also meet—have a conference call with the laboratory directors once a month, and these issues come up then. We haven’t 

heard—we know there is concern out there, not to the extent that 

28 laboratories have expressed that level of concern throughout the 

course of this contract revision. 

Mr. LANGEVIN. What about the resource complaints, that we are 

not reimbursing for things that they consider to be priorities? 

Mr. HOOKS. Sir, the current construct is the same as when the 

BioWatch program started. We expect to be paying for the personnel, the reagents, and the test equipment that are used to process BioWatch samples. We understand on the local laboratory side 

there are indirect costs associated with the space that is used for 

the BioWatch samples. 

It should be pointed out that from 2003 to 2008 the number of 

collectors that were being used in the jurisdiction that this laboratory was supporting increased by a figure of two—or actually, a figure of three, and so that is going to cause more samples to be analyzed. We expect to be able to cover the costs, those direct costs of 

the people, the reagents, and the test equipment for the laboratory. 

We are not asking them to take on that burden. 

So this clearly conveys that the communication needs to improve 

better with each of the laboratories so that they understand the position, where we have been. As appropriate, we need to revisit, is 

this the best relationship construct that is in place, since it is the 

same one that was put in place when the BioWatch system was 

stood up very quickly in a 90-day period back in 2003? 

Mr. LANGEVIN. Given the seriousness of what I consider to be the 

biothreat and the fact that we need strong Federal, State, and local 

partners, I don’t want to be doing this on the cheap. If we need to 

provide more resources, you have got to either provide them or 

speak up and say, you need more, and then the Congress has to 

do more in that area. But we can’t obviously be doing this on the 

cheap, and then not having the State and locals feel that they 

aren’t being supported and this isn’t a good partnership. 

Dr. Downes, let me turn to you again. Would you care to respond 

to any of the things that you have heard in response to your testimony? 

Dr. DOWNES. One comment I would make is that the monthly 

calls with what DHS calls the ‘‘BioWatch lab director’’ is not someone in my role. It is not the person who is the administrator or the 

quality assurance regulatory lab director. They are more of what 

we call a section manager, or a smaller laboratory unit manager, 

and much more technical in nature. So they may not be conveying 

the resource issue as—because they are not responsible for the 

overall management of the laboratory the way that someone in my 

position is. 

I think that is a separate dialog that we need to open, as opposed 

to the technical discussions that have been on a monthly basis. 

Mr. LANGEVIN. Very well. We will continue to follow this. 

Mr. Jenkins, do you care to respond to anything that you heard 

in the testimony? 

Mr. JENKINS. No, sir. We haven’t looked at this particular issue 

that has been raised here and discussed here. 

Mr. LANGEVIN. Okay. 
58 

Let me just, before I turn to Ms. Christensen, I do have one question that I need to get to that is a priority. It is, currently the 

BioWatch system uses environmental sample collectors called Generation 1, Generation 2 detectors, as we have heard in testimony, 

that are collected once a day and analyzed in public health laboratories that are members of the Laboratory Response Network. 

Generation 3 detectors, which are automated and do not require 

physical chemical analysis at an LRN lab, are supposed to replace 

them, but that deployment keeps slipping. Obviously, the Generation 1 and Generation 2 detectors require a lot of human interaction. There are several hours—actually, several days of delay before we actually have results. I think it goes anywhere from 24 to 

36 hours before we actually have results. Obviously the Generation 

3 detectors are near real time, with very little to no human interaction required to get the results back, which obviously are more 

preferable. That is why we want to move in that direction. 

Clearly, we are not going fast enough as far as I am concerned. 

But the congressional justification for the fiscal year 2007 budget 

request submitted by the Science and Technology Directorate said 

that BioWatch would have fieldable prototypes in fiscal year 2007, 

and a Generation 3 BioWatch pilot in fiscal year 2008. 

Now, the fiscal year 2008 congressional justification submitted by 

the Office of Health Affairs called for, ‘‘operational testing of Generation 3 BioWatch monitoring systems, which are planned to 

begin in fiscal year 2008.’’ In fiscal year 2009, the congressional 

justification submitted by Office of Health Affairs changed to—and 

again I quote—‘‘fiscal year 2009, which OHA plans a 6-month 

multicity operational test and evaluation of advanced automated 

technologies. This will allow Office of Health Affairs to advance to 

a full rate production procurement decision for advanced technology deployment in fiscal year 2010.’’ 

Now, finally, in testimony before the House Appropriations Committee on April 1, 2008, DHS Medical Officer Dr. Jeff Runge stated, quote again, that ‘‘our target for that is April of 2009 to do that 

head-to-head flyoff with whoever is ready, because we need to get 

technology ready, tested, thoroughly evaluated, boxes into the field, 

and to a large volume in 2010 and 2011.’’ 

So we slipped from deployment, a deployed pilot in 2008, back to 

operational testing in 2009, and maybe to deploy some units in 

2010 or 2011. This concerns me. I want to know why the deployment has been continually delayed. Were the projections too optimistic? Are you running into severe technical difficulties? Are the 

companies underperforming? 

We can start with those. Do you have, in fact, a drop-dead date 

where you either have a product ready or you rewrite your requirements and open the process? 

I am going to ask for comments both from Mr. Hooks and Mr. 

Stiefel, and I am going to ask for Mr. Jenkins to comment. 

Mr. HOOKS. Sir, as the BioWatch program has matured and moving to look to Generation 3 technology from the Generation 1 and 

2 technology, as you discussed, getting into automated detection, 

technical requirements were written for that Generation 3 technology that were aggressive and probably appropriate requirements, trying to stretch the envelope of science and technology. 
59 

But there is always a risk in technological development that the 

science breakthroughs won’t come as fast or as regular as we would 

like and desire in a technology deployment. I think, over the period 

of time, as we have managed the program, we have looked at optimistically being able to field a technology earlier than was actually 

realistic. 

There is the balance point between—in the technology development that we ensure that we are looking far enough into the future 

of the technology we need to support the operations, so it is usable 

by the end-user community, such as the public health laboratory 

community, and at the same time managing the risk, to ensure we 

put the proper level of controls on that technology-development 

cycle—technical readiness assessments, test and evaluation procedures—at the same time trying to urgently get new technology out 

into the field. I think that has been the challenge, that some of the 

projections may have been over-optimistic. 

I think, as we are getting closer to the deployment of a Generation 3 technology and the Generation 2.5 technology, the plan always becomes more clear, because you are further down the technical maturity cycle of the technology, so you can gauge more carefully. There are fewer scientific breakthroughs and discoveries that 

are necessary. 

As you mentioned, Dr. Runge has said that the flyoff was scheduled for Generation 3 in April 2009. We are still on track for that. 

That is our plan, to fly off any technologies that meet the Generation 3 technologies, whether they have been developed within 

Science and Technology Directorate or are available on the commercial market. But it has already undergone a rigorous independent test and evaluation so we are not wasting time and money 

testing technologies that we know won’t work. 

Mr. LANGEVIN. Do you have a drop-dead date where you either 

have the product ready or you are going to rewrite the requirements and open the process? 

Mr. HOOKS. Right now that is April 2009. I don’t know that we 

would re-open the requirements process. We would look at that. It 

may be appropriate. If there is no technology that is ready to test 

as we are working through this cycle to Generation 3, then it would 

probably be more appropriate to delay, because we do need that 

level of automated technology. 

We do have units, we do have prototype automated technology 

units in place in New York City, an earlier version of a potential 

Gen-3 solution. That may be the trade-off decision. The reason we 

want to get to Generation 3 is because of the significantly lower 

cost of procurement and operation, as well as improved specificity 

to identify the pathogens of concern, as Mr. Jenkins has mentioned. 

That is important, and that is where we want to get. If we can’t 

get there because our tests and evaluation and independent results 

convey that that is not possible, then we do need to look for an alternative interim solution to move forward and do the cost-benefit 

analysis on that. 

Mr. LANGEVIN. Thank you. 

Mr. Stiefel, I would like you to comment on this, as well. 

Dr. STIEFEL. Yes, sir. Actually, what Mr. Hooks said is exactly 

right. But there is another important component to this that we 
60 

have to understand, and that is, whatever technology we field has 

to be good. It has to be trusted. It has to be public-health-actionable. So that when a signal comes in and it is considered a 

BioWatch-actionable result or a positive, that actions can be taken 

and the public health trusts that action. 

As Dr. Downes can rightly tell you, the current assays that we 

have are CDC, public-health-actionable assays. The systems that 

are in our Gen 2.5 system are public-health-actionable assays. So 

we can’t afford to put a system out there that is going to make a 

mistake, because the actions of that mistake are tremendous, especially in large airport or other large transit facilities. 

So we need to get this right. Right now, April 2009, as Mr. Hooks 

says, is a good date. On the other hand, if technology didn’t advance enough to be able to give us that system that we have full 

trust and confidence in that you would expect us to field, we potentially would have to slip. But at this point, we don’t see that happening. 

Mr. LANGEVIN. Thank you. 

Mr. Jenkins, do you have anything to add? 

Mr. JENKINS. I would make a couple of points here. 

One is that if there are issues with 3.0, in terms of slippage or 

whatever the issue is, as to what extent does 2.5 help buy you 

time, the basic thing in 2.5 is that it detects the same number of 

agents that is currently being detected, it just automatically analyzes them. 

If there are no new assay tests developed, then the 3.0, when it 

is deployed, will still only detect the same number of agents that 

are currently being detected. It has, as I said—I was very careful 

in the wording—potentially the capability to detect all of those on 

the list. But until there is, as I said, the proved CDC assay test 

for these, they can’t add those to the system. 

So, initially, it may be that the 3.0 only is detecting the same 

number the 2.0 is and 2.5 is. I think if there are issues here with 

regard to getting this right, the question is, what do I get in 2.5 

and what do I not have that 3.0 will bring on? That is what we 

haven’t really heard them talk about. 

Mr. LANGEVIN. Mr. Stiefel, how would you respond to Mr. Jenkins on that point? 

Dr. STIEFEL. What Generation 2.5 gives us today, because we are 

operational in New York City in a couple of venues, is getting that 

detection time down from 10 to 34 hours, because we collect for a 

24-hour period of time, down to 4 to 6 hours. We actually collect 

every 2 hours, and then the assays run for 2 hours while we are 

collecting for the next 2 hours. 

New York City will take full appropriate actions based on a positive from any one of those machines. That signal goes to the lab 

director. That is who makes that determination of a positive. 

What Gen 2.5 will give us is essentially most of the requirements 

in Gen 2.3 but not all of them. It doesn’t give us the 30-day cycle 

to put more reagents into the machine instead of seven. It can go 

up well beyond the six agents, the five agents that we currently 

screen for. But, as Mr. Jenkins says, they have to be public-healthactionable CDC-approved assays. 
61 

So 2.5 actually buys us significant time, but at the same cost, it is $40,000, $50,000, $60,000 more because we are making them in 

such limited numbers. 

Mr. LANGEVIN. Thank you. 

Well, with that, I am going to turn to Ms. Christensen for her 

questions. Thank you for bearing with us, as we drill down a little 

bit on this. 

Mrs. CHRISTENSEN. Thank you, Mr. Chairman. 

One of my questions referred to the automatic pathogen detection 

system also. So you are saying that—my question would have been, 

is that use a wise use of resources and a good way to bridge? But 

you are saying, yes, it is, because it covers the things that you have 

assays for. 

Mr. HOOKS. Yes, ma’am. Going to automated detection is critical 

for our biosurveillance efforts for several reasons. One is it does reduce the time of detection on average right now by about 24 hours, 

which is critical to be able to respond earlier following a biological 

attack, that it be identified. 

Additionally, there are certain higher-risk venues, such as indoor 

facilities, where the current delay time on samples from an ability 

to detect in the 10 to 34 hours just does not work in the concept 

of operations. The cities have told us that they will not deploy the 

Generation 1 and 2 systems into those higher-risk venues, which 

are high through-put transportation environments such as subway 

systems or into airports and whatnot. 

Mrs. CHRISTENSEN. From the time this committee was a select 

committee, we have always talked about having genetically altered 

or created pathogens. How far away are we from a point at which 

we can detect those kinds of pathogens that have never existed before or have been very much altered? 

Mr. HOOKS. Genetically altered pathogens and other engineered 

threats are a concern to us. The technology is not there at this time 

to deploy into a BioWatch system. As we look forward to the future 

of a Generation 4 system, that is a key component that we need 

to be able to address in that. 

It is not clear to me if it is optimistic or realistic at this point, 

but our best guess is that is probably 3 to 5 years out. But please 

don’t hold me to that. 

Mrs. CHRISTENSEN. No, you have gotten into enough trouble over 

dates and deadlines here today. 

Mr. HOOKS. Yes, ma’am. 

Mrs. CHRISTENSEN. Back to the lab for a minute. Why is it necessary to have a contractor, an in-between person between you and 

the laboratory? Wouldn’t be it just easier to contract with the labs 

directly? 

Mr. HOOKS. I am going to defer that one to Mr. Stiefel. 

Dr. STIEFEL. Actually, when the program first started—and it 

started so quickly—CDC put emergency hires in place through 

CDC, converted them over to temporary hires, term hires. It came 

to a point when CDC wanted to back away from that, because that 

was a large expense and these people were given no benefits. So 

we talked to the lab directors, and through CDC the only possible 

venue for us to go to, at that point, was to turn to a contracting 

scenario to put these laboratory personnel into the laboratory. 
62 

We have also had requests from other labs and, for example, in 

Minnesota, where they have requested the possibility of putting 

State employees through a CDC grant or through some kind of 

grant. We have actually looked into that, and we have been looking 

into that for about a year. Many of the labs that I have spoken to 

would like that. The problem is that the States themselves are on 

hiring freezes, and even if we were to provide them money, they 

wouldn’t have the ability to add these additional slots. 

So we are looking at lots of different ways in order to compensate: one, through contracting. Another one is potentially public 

health officers from HHS that could go into these laboratories. Another venue would be, wherever possible, to try to hire State employees through a COTPER grant with HHS and CDC. 

Mrs. CHRISTENSEN. Dr. Downes, you may want to follow up on 

that question and answer. But I was also wondering, are the State 

of Michigan employees in the laboratory put at any risk because of 

the limitations imposed on you by the DHS BioWatch contract? 

Dr. DOWNES. We do treat those employees as if they are our own 

and require them to go through our safety training. Our concern 

is that, if we had somebody who was not performing to those standards, the fire safety program, that it would be—I have no mechanism at this point to dismiss that person immediately, for example. 

Or if the quality of their testing was not appropriate or they were 

disruptive in any sort of way within our facility, we would have no 

way to immediately take them out of the laboratory setting. So in 

that regard, they do potentially put our employees at risk. 

In regard to the contracting, direct contracting issue, I don’t recall having a discussion in which we were given the option of directly contracting with DHS. I recall that it was not put on the 

table as an option. 

But, as Dr. Stiefel says, one contracting mechanism may not 

work in all States or local laboratories, and that having more of a 

portfolio of options would probably be the best and most direct way 

to accomplish achieving the through-put, as well as assuring quality and safety. 

Mrs. CHRISTENSEN. Okay, thank you. 

Either Mr. Hooks or Dr. Stiefel, the January 17, 2008, letter 

from the Association of Public Health Laboratories that was sent 

to Assistant Secretary Runge, do you know if it has been responded 

to? 

It had outlined a number of concerns from member laboratories 

about personnel matters that developed with the award of the new 

BioWatch contract and suggested options for improvement. 

Has that been responded to yet? 

Mr. HOOKS. That letter was in response to a meeting that was 

held with Dr. Runge, the Principal Deputy Assistant Secretary, and 

my predecessor in my present position, along with Dr. Stiefel. The 

larger content of that letter from January 17 was to address discussing a variety of preparedness issues and whatnot. 

There are, within there, paragraphs that mention that they were 

glad that they were able to discuss some of the issues that were 

on the table. From the reading of the letter, where it says, ‘‘Thank 

you very much for the meeting,’’ in reading the letter the Office of 

Health Affairs did not feel that it needed a response. It was not 
63 

meant to be a snub of no response. The assumption was that the 

communication and dialog was continuing with a PHL. 

So the sense was this was a closure letter to a meeting, not raising larger issues. It mentioned moving forward: ‘‘We reiterate our 

interest in working collaboratively.’’ We completely concur and 

agree with that. 

Mrs. CHRISTENSEN. Thank you. 

My last question is more of a process: How do you work? There 

was a well-reported detection of tularemia bacteria in the District 

of Columbia a few years ago, and it was eventually decided that 

it was a naturally occurring bacteria rather than a biological attack. 

I am a little more paranoid than most people. So everything to 

me, you know, all the food stuff, you know, I wonder. 

But how does the Department decide whether a positive test 

came from a naturally occurring event rather than a deliberate release? What are some of the factors that influence how quickly that 

determination is made? 

Mr. HOOKS. So when a BioWatch signal comes up and it is determined to be a BioWatch-actionable result because there is nucleic 

acid on that filter that indicates that there is a pathogen—not a 

pathogen, but that there is nucleic acid that could be from that 

pathogen—the decision is made at the local laboratory by the laboratory director, such as Dr. Downes. 

In that case, there are procedures in place. At the national level, 

we have provided Federal guidance documents that discuss the preparedness, the response and the sampling for that event. There are 

very detailed procedures in place that have been put in place by 

each of the jurisdictions that we refer to as concept of operations. 

Each of the jurisdictions has a BioWatch Advisory Committee, 

which is made up of different people in the local community, including the public health director or their representative. There 

will be representatives from the mayor’s office or other city officials, from the FBI, locals, other public health officials that come 

together. They analyze what that BioWatch-actionable result says 

and what it does potentially mean. 

They will look at a variety of different factors. The FBI will be 

looking: Is there intelligence information that would convey that 

we are at a higher risk of a potential attack? They will look at: 

Was it only detected on one collector or multiple collectors? That 

will give indication. They will look at the environmental conditions, 

as well. EPA is represented in this BioWatch Advisory Committee. 

To ensure that this works effectively, there is a normal protocol. 

We have a BioWatch exercise and evaluation program that is done 

annually with each of the jurisdictions, where we send out people 

from the national office that evaluate the protocols and procedures 

that are ongoing in each of the local jurisdictions to ensure that 

they do meet a high quality. Because, as mentioned previously, 

there are potential high-regret actions that could be taken, and we 

don’t want to ever get it wrong. 

Also, there are tabletop exercises that are done either under the 

auspices of the national office or certain jurisdictions choose to do 

them on their own. We will send representatives to assist in that. 
64 

So this really is a partnership. We want to get it right every 

time. 

There have been 37 environmental positives where there was actually a detection of nucleic acid since the program has begun. In 

each of those cases, the local jurisdictions have walked through the 

protocols that are in place, executed, and determined that it did not 

cause a public health risk. 

We use those lessons learned from those events, from the tabletop exercises. Those are shared on a BioWatch portal to all of the 

jurisdictions so that we can learn from each other. They are briefed 

at the national conference every year to ensure that that information is passed, as well. 

Part of that is looking: How can we improve those procedures to 

be more efficient and effective, but still maintain that high level of 

quality necessary on a program of this type? 

Mrs. CHRISTENSEN. So it is probably the intelligence side that 

helps to really make that determination or—well, I heard a couple 

of factors. Thank you. 

Thank you, Mr. Chairman. 

Mr. LANGEVIN. I thank the gentlelady. 

Before I conclude the hearing, let me just say that I would ask 

that we all redouble our efforts on this issue of being better prepared for prevention, detection and response to potential biological 

threats, whether they be emerging threats from naturally occurring 

things or from man-made potential biological attacks. 

I take this issue very seriously. It truly concerns me. This subcommittee has jurisdiction over the Department’s activities, and 

trying to prevent some of the scariest things, the things with the 

most devastating consequences that could face the country, whether dealing with a nuclear attack, preventing radiological attack, biological or chemical attack on the country. 

Clearly, of all the things, a nuclear attack would be very likely 

the most devastating. But, thankfully, Mother Nature didn’t make 

it easy for us or anyone to acquire weapons-grade plutonium or 

highly enriched uranium. The same is not the case for biological attacks, which could possibly be just as catastrophic in terms of loss 

of life. 

The problem is, as experts have testified before this subcommittee before, someone with a basic degree in biology could 

cause a threat to public health. As technology proliferates and becomes more sophisticated and easy to acquire, especially those 

technologies that have dual-use technology, nebulizers and such, 

that are available on the open market, someone could cause real 

harm to the country through a biological attack and could cause 

massive loss of life. This keeps me up at night. We need to redouble our efforts to protect the country from these things. 

Clearly, and if someone does develop that capability, what concerns me, unlike in the unlikely event of a nuclear attack, people 

would be able to do this biological attack again and again and 

again. We can’t ever allow that to happen. 

I want to thank our witnesses for their efforts and their testimony. 

Again, I want to thank Ms. Christensen for her patience and 

staying through this second hearing, as well as our witnesses. 
65 

The Members of the subcommittee may have additional questions 

for the witnesses that we will ask that you respond expeditiously 

in writing. 

Having no further business, the subcommittee now stands adjourned. 

[Whereupon, at 6:06 p.m., the subcommittee was adjourned.] 

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