The BioWatch Program: Detection of Bioterrorism

Congressional research reportNov 19, 2003

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The BioWatch Program:

Detection of Bioterrorism

November 19, 2003

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Analyst in Science and Technology Policy

Resources, Science, and Industry Division

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Specialist in Social Legislation

Domestic Social Policy Division

Congressional Research Service ˜ The Library of Congress

The BioWatch Program:

Detection of Bioterrorism

Summary

The anthrax mailings of 2001 increased public and governmental awareness of

the threat of terrorism using biological weapons. The federal response to this threat

includes increases in countermeasure research funding, greater investment in public

health infrastructure, and greater preparation of first responders who might be the

first to encounter such weapons in an event. The new Department of Homeland

Security (DHS) has made preparation against biological weapon attack a priority and

deployed the BioWatch Program to provide early warning of a mass pathogen

release.

The BioWatch Program uses a series of pathogen detectors co-located with

Environmental Protection Agency air quality monitors. These detectors collect

airborne particles onto filters, which are subsequently transported to laboratories for

analysis. It is expected that this system will provide early warning of a pathogen

release, alerting authorities before victims begin to show symptoms and providing

the opportunity to deliver treatments earlier, decreasing illness and death.

The BioWatch Program, funded and overseen by DHS, has three main elements

each coordinated by different agencies, sampling, analysis, and response. The

Environmental Protection Agency (EPA) maintains the sampling component, the

sensors that collect airborne particles. The Centers for Disease Control and

Prevention (CDC) coordinates analysis, the laboratory testing of the samples, though

testing is actually carried out in state and local public health laboratories. Local

jurisdictions are responsible for the public health response to positive findings. The

Federal Bureau of Investigation (FBI) is designated as the lead agency for the law

enforcement response if a bioterrorism event is detected. The BioWatch Program has

raised concerns in some quarters, with questions about its general effectiveness, the

siting of pathogen detectors, the reliability of its results, its cost and workforce

requirements, and the ability of public health officials to respond to BioWatch

results. Efforts to develop integrated response plans, lower the system cost, and

develop complementary and next-generation systems continue.

Some aspects of the BioWatch Program may be of particular interest to

policymakers. For example, Congress may be interested in whether these types of

detection systems can substitute for or supplement other mechanisms in protecting

the general populace; whether this detection system was implemented optimally; how

the success of this system is to be evaluated; whether the implementation,

operational, and expansion costs for the BioWatch Program make it a cost-effective

federal investment; and how to optimize and streamline performance in the future.

Since the BioWatch Program is a federal program implemented using state

infrastructure, Congress may wish to examine how this new program coordinates

with already existing public health and counterterrorism programs, as well as

consider the roles and responsibilities of the federal government and coordination

with state governments in an actual bioterrorism event.

Contents

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

What is the BioWatch Program? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

Reactions to the BioWatch Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Strategic Issues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Sensor Siting Issues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Analytical Issues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Public Health Response Issues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Future Directions of the BioWatch Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

Policy Concerns . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

Significant Role of Detection Systems in DHS Strategy . . . . . . . . . . . . . . . 14

Deployment of Other DHS Programs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

Evaluating Effectiveness . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

Funding for the BioWatch Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

Future BioWatch Development Priorities . . . . . . . . . . . . . . . . . . . . . . . . . . 19

Coordinating Bioterrorism Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

Clarifying Roles and Responsibilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

The BioWatch Program:

Detection of Bioterrorism

Introduction

During the 2003 State of the Union address, President Bush announced that the

federal government was “deploying the nation’s first early warning network of

sensors to detect biological attack.”1 The newly formed Department of Homeland

Security (DHS), is responsible for deploying this network, the BioWatch Program,

reportedly as part of the Biological Warning and Incident Characterization System.2

Funded and overseen by DHS, the program has three main elements each coordinated

by different agencies, sampling, analysis, and response. The Environmental

Protection Agency (EPA) maintains the sampling component, the sensors that collect

airborne particles. The Centers for Disease Control and Prevention (CDC)

coordinates analysis, the laboratory testing of the samples, though testing is actually

carried out in state and local public health laboratories. Local jurisdictions are

responsible for the public health response to positive findings. The Federal Bureau

of Investigation (FBI) is designated as the lead agency for the law enforcement

response if a bioterrorism event is detected. The installation of the sensor network is

ongoing, with over 30 cities chosen as locations for these sensors.3

The detection of a covert act of bioterrorism, unless detected by the BioWatch

Program, is likely to occur through the diagnosis of ill victims. Detection is delayed

from the time of the actual event by the time required to develop symptoms and

report them. For many pathogens, early treatment, preferably before symptoms

develop, is key to preventing casualties. If early detection is achieved, it is predicted

that therapeutic agents could be provided in a timely manner to those exposed,

reducing the effectiveness of such an attack and averting the potentially catastrophic

nature of mass pathogen releases. While pathogen detection systems are employed

by the military, such systems were not previously deployed on such a scale in the

civilian sector.

“State of the Union Address,” Executive Office of the President, The White House, January

28, 2003, found online at

[http://www.whitehouse.gov/news/releases/2003/01/20030128-19.html].

For a short description of the Biological Warning and Incident Characterization System,

see the statement of Under Secretary Dr. Charles E. McQueary, Department of Homeland

Security, Science and Technology Directorate, before the House Select Committee on

Homeland Security Subcommittee on Cybersecurity, Science, and Research and

Development, at a hearing titled “Homeland Security Science and Technology: Preparing

for the Future,” on May 21, 2003.

The White House, Progress Report On The Global War On Terrorism, September 2003,

p. 14.

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A fundamental question to be asked of the BioWatch Program is whether it is

an appropriate federal response to the threat of bioterrorism. The historic cases of

bioterrorism within the United States have been small in scope, and likely would not

be detected by the current system. Additionally, the Central Intelligence Agency has

reported that while al-Qaeda maintains the goal of mass casualties, most attacks will

be small scale.4 The deployment of a bioterrorism detection system with a primary

goal of detecting large releases of pathogen may not be viewed as the optimum

response to the current threat.

The BioWatch Program garners public and Congressional interest for a variety

of reasons, including its cost, the future development and testing of similar systems,

the effectiveness of the currently deployed system, the process by which this program

was chosen and deployed, and the consequence-management process envisioned in

response to a BioWatch warning. These issues may raise questions about the role

that the Department of Homeland Security plays with respect to the public health

infrastructure, aspects of federal and state communication and coordination, and the

role of the federal and state governments in protecting the populace against biological

attack.

What is the BioWatch Program?

The function of the BioWatch Program is to detect the release of pathogens into

the air, providing warning to the government and public health community of a

potential bioterror event. While there is limited federal government description of

the BioWatch Program, there have been media reports describing the functional

concept.5 According to these reports, aerosol samplers mounted on preexisting EPA

air quality monitoring stations collect air, passing it through filters. These filters are

manually collected at regular, reportedly 24-hour, intervals6 and are analyzed for

potential biological weapon pathogens using polymerase chain reaction (PCR)

techniques.7 While filters from the BioWatch program were initially shipped to and

tested at a federal laboratory in California, state and local public health laboratories

now perform the analyses.8 News reports suggest that the system tests for the

Directorate of Intelligence, Central Intelligence Agency, Terrorist CBRN: Materials and

Effects, June, 2003.

For example, see Judith Miller, “U.S. Deploying Monitor System For Germ Peril,” The New

York Times, January 22, 2003, p. A1; Kathy Sawyer, “Biowarfare Monitors Are Deployed

in U.S.,” The Washington Post, January 23, 2003, p. A6; and Julie Deardorff, “City’s Air

Monitored for Bioterror Attack: Early Detection System Criticized,” Chicago Tribune, April

6, 2003, p. 1C.

This interval could be changed at the operator's discretion. Dina Cappiello, "‘BioWatch'

to Sound Alarm; Monitors Screen Air Quality for Bacteria Attack," Houston Chronicle, July

29, 2003, p. A11.

PCR is a common method of creating many copies of specific fragments of DNA. In

theory, PCR could allow the detection and identification of just a few pathogens on a given

filter.

See Michael Lasalandra, “Boston Joins National Bio-warfare Alert Network,” Boston

(continued...)

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pathogens that cause anthrax, smallpox, plague, and tularemia (a bacterial illness,

sometimes called “rabbit fever”), but the entire list of pathogens is not publicly

available.9

The BioWatch equipment is fielded in select cities, reportedly including

Philadelphia, New York City, Washington, DC, San Diego, Boston, Chicago, San

Francisco, St. Louis, Houston, and Los Angeles.10 The Department of Homeland

Security has not confirmed the exact number of cities engaged in the BioWatch

program, nor the number of pathogens that are detected using BioWatch equipment.11

It is reported that at least 31 cities are included in the BioWatch program, while

according to the minutes of a Centers for Disease Control and Prevention (CDC)

Information Council meeting, the program may expand to as many as 120 cities.12

While the exact cost of this program is unknown, the capital costs for installation in

a single city are estimated at $1 million and the yearly budget for operation at $1

million per city.13

The press has reported that the state and local public health labs conducting

BioWatch testing are all part of the national Laboratory Response Network for

Bioterrorism (LRN).14 The LRN is a nationwide network composed primarily of

local, state, and federal government laboratories that provide confirmatory testing of

potential bioterrorism pathogens, using consensus protocols. It was developed by

Centers for Disease Control and Prevention (CDC), the Federal Bureau of

Investigation, and the Association of Public Health Laboratories prior to the anthrax

mailings of 2001. It provides confirmatory testing in all 50 state public health labs,

and in additional locations.15 There are currently 118 member labs in the LRN.

(...continued)

Herald, March 14, 2003, p. 5.

Ibid.

City list compiled from the following news articles: David B. Caruso, “Devices Sniff Out

Bioterror, But Experts Question Effectiveness,” The Associated Press, July 11, 2003; and

Dina Cappiello, “‘BioWatch’ to Sound Alarm; Monitors Screen Air Quality for Bacteria

Attack,” Houston Chronicle, July 29, 2003, p. A11.

David B. Caruso, op cit.

Comments made in “Meeting Minutes,” CDC Information Council, February 27, 2003,

found online at

[http://www.cdc.gov/cic/minutes/CIC%20minutes%202-27-03.pdf].

“Nationwide Monitoring System Planned For Detecting Bioterror Attack,” The Asssociated

Press, January 22, 2003.

“BioWatch Program Aims For Nationwide Detection of Airborne Pathogens,” CIDRAP

News, February 26, 2003, revised March 10, 2003.

For background on the LRN, see M. J. R. Gilchrist, “A National Laboratory Network for

Bioterrorism: Evolution from a Prototype Network of Laboratories Performing Routine

Surveillance,” Military Medicine, Vol.165, Supplement 2, 2000, and A.P. Perkins, T.

Popovic, and K. Yeskey, “Public Health in the Time of Bioterrorism,” Emerging Infectious

Diseases, Vol. 8, Oct. 2002, available at [http://www.cdc.gov/ncidod/EID/vol8no10/02(continued...)

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BioWatch equipment is heavily based on the Biological Aerosol Sentry and

Information System (BASIS), a system developed within the Chemical and

Biological National Security Program of the National Nuclear Security

Administration (now part of the Department of Homeland Security) by scientists at

Lawrence Livermore and Los Alamos National Laboratories.16 BASIS is comprised

of an air collector coupled to a series of filters. Airborne particles passing through

the system are captured on a filter. The filter mechanism is designed to roughly

determine when an attack occurred by using sequential filters automatically rotated

on an hourly basis. Filters are removed and tested using PCR for the presence of

select pathogens.

BASIS was deployed for both indoor and outdoor monitoring at the Salt Lake

City Olympics in 2002, and was also tested and characterized in urban settings.17

Some conclusions about instrument performance based on these tests were released.

BASIS was characterized as having high specificity, with fewer than 0.005% false

positives per filter measurement,18 and high sensitivity.19 However, BASIS was

noted to be labor intensive, requiring people to collect filters and perform PCR

testing and analysis.

The first incident of a positive BioWatch result was reported on October 9, 2003

in Houston, Texas. The Houston Department of Health and Human Services reported

detecting low levels of the bacterium that causes tularemia. According to a press

release, positive results were detected on three consecutive days, with negative

results on subsequent days.20 The response to the positive result was a modest one

with precautionary measures being taken by the local and state public health

agencies, including increased surveillance for human illness; additional

environmental sampling and testing; and assessment of activities in the area that may

have caused the sensors to pick up the organism. There are no indications that this

(...continued)

0444.htm]. See also Department of Health and Human Services, Public Health Emergency

Preparedness: Transforming America’s Capacity to Respond, Fact Sheet, September 11,

2003.

Vin LoPresti, “Guarding the Air We Breathe,” Los Alamos Research Quarterly, Spring,

2003. See also United States General Accounting Office, Bioterrorism: Information

Technology Strategy Could Strengthen Federal Agencies’ Ability To Respond To Public

Health Emergencies, GAO-03-139, May 2003.

“Technology Will Be Used at 2002 Winter Olympics,” Newsline, February 8, 2002.

A false positive rate refers to how often a system signals the presence of a pathogen when

no pathogen exists. A false positive rate of less than 0.005% corresponds to less than one

false positive result per 20,000 tests. Vin LoPresti, op cit.

Test methods are described according to sensitivity, the ability to detect an agent when it

is present, and specificity, the ability to yield a negative result when the agent is not present.

Specificity requires that the method does not detect closely related organisms, but only the

organism(s) of interest.

Houston Department of Health and Human Services, “Officials Following Up on Bacteria

Detection,” Press Release, October 9, 2003, found online at

[http://www.ci.houston.tx.us/departme/health/bacteria%20detection.htm].

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signal was the result of an intentional pathogen release, but investigation is ongoing

with federal, state and local agency participation.21 The Director of the Houston

Department of Health and Human Services stated, “We are investigating to determine

if the bacteria was always present or newly present and if it represents a health threat

to the community.” These findings may likely reflect natural “background” levels

of the organism in the environment, and authorities have chosen to enhance

surveillance rather than distributing antibiotics in the affected community.22

Reactions to the BioWatch Program

The BioWatch program has received a mixed reaction from experts. While

acknowledging the program may address a noted homeland security vulnerability,

commentators and analysts have raised concerns in a number of areas. This section

presents some of these concerns, including overall strategy, sensor siting, detector

performance, and public health response.

Strategic Issues

Countering the threat of terrorist use of weapons of mass destruction against

civilians has taken on new priority since the anthrax mailings of 2001. President

Bush, when announcing the deployment of the BioWatch program during the 2003

State of the Union Address, stated,

Today, the gravest danger in the war on terror, the gravest danger facing America

and the world, is outlaw regimes that seek and possess nuclear, chemical, and

biological weapons. These regimes could use such weapons for blackmail, terror,

and mass murder. They could also give or sell those weapons to terrorist allies,

who would use them without the least hesitation.23

A goal of the BioWatch program is detection of large releases of biological

weapons, some of which might potentially cause thousands of casualties.24 Early

notification of a biological attack is presumed to provide a significant advantage in

preventing and treating casualties. Such a “detect to treat”25 warning system may

Ibid.

See also Eric Berger, “Suspicious Bacteria Detected: Security Monitors Spot Germ;

Terrorism Discounted,” Houston Chronicle, October 10, 2003, p. A27, and Robert Roos,

“Signs of Tularemia Agent Detected in Houston Air,” CIDRAP News, October 10, 2003.

“State of the Union Address,” Executive Office of the President, The White House,

January 28, 2003, found online at

[http://www.whitehouse.gov/news/releases/2003/01/20030128-19.html].

For an overview of the impacts of weapons of mass destruction, see Office of Technology

Assessment, U.S. Congress, Proliferation of Weapons of Mass Destruction; Assessing the

Risks, OTA-ISC-559, (Washington, DC, U.S. Government Printing Office) August 1993.

A “detect to treat” technology provides early notification of a biological attack, so that

effective treatment for those made ill can be provided. This differs from a “detect to warn”

technology which provides warning of an event before infection occurs. “Detect to treat”

(continued...)

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limit casualties and fatalities by allowing earlier medical service to the exposed,

avoiding disease progression. A modeling study concludes that while the earliest

possible detection of a hypothetical urban anthrax release still cannot prevent all

deaths, the proportion of lives saved by detection and intervention within the first day

after the event (before symptoms appear in those exposed) is approximately 40%.26

With increasing delay between detection and treatment, greater casualties occur.

Some experts question whether mass biological attack is the most probable

terrorist threat, and suggest that more localized attacks are more likely.27 It is

suggested by some that the BioWatch monitors would not likely detect indoor or

underground releases, such as within a building or a subway system.28 There are

historical examples of both indoor releases, the U.S. anthrax mailings in 2001, and

outdoor releases, such as the suspected accidental anthrax release at Sverdlovsk (now

Ekaterinburg), Russia in 1979.29

Factors influencing the choice of locales to be monitored are another area of

discussion. BioWatch monitors are reportedly deployed in major cities. A successful

mass biological attack on a large city would likely cause high casualties. The

perceived prestige conferred upon a terrorist group following a successful, large-scale

attack may lead terrorist groups to preferentially target cities.30 Some posit that these

factors, among others, require special consideration for major cities. For example,

in the debate over homeland security spending, some have asserted that homeland

security funds should be allocated using formulas that take into account threats,

population density, and the presence of critical infrastructure, rather than on a per

capita basis.31 In contrast, some have claimed that successful aerosol dissemination

(...continued)

and “detect to warn” technologies differ in timescale, with “detect to warn” technologies

having to detect in real time, a much more difficult task. For a discussion of these issues,

see Jeffery H. Grotte, Frequently Asked Questions Regarding Biological Detection, Institute

for Defense Analysis, Alexandria, Va., November 2001.

Lawrence M. Wein, David L. Craft, and Edward H. Kaplan, “Emergency Response to an

Anthrax Attack,” Proceedings of the National Academy of Sciences of the United States of

America, Vol. 100, April 1, 2003, and Lawrence M. Wein, personal communication,

September 8, 2003.

For a representative view, see Amy Smithson and Leslie-Anne Levy, Ataxia: The Chemical

and Biological Terrorism Threat and the US Response, The Henry L. Stimson Center,

Report No. 35, October 2000.

Julie Deardorff, “City’s Air Monitored for Bioterror Attack: Early Detection System

Criticized,” Chicago Tribune, April 6, 2003, p. C1.

For a discussion of the anthrax epidemic of Sverdlovsk, see Matthew Meselson, Jeanne

Guillemin, Martin Hugh-Jones, et al., “The Sverdlovsk Anthrax Outbreak of 1979,” Science,

Vol. 266, November 18, 1994.

For an overview of factors which may influence a terrorist group to use chemical or

biological weapons, see CRS Report RL31831 Terrorist Motivations for Chemical and

Biological Weapons Use: Placing the Threat in Context by(name redacted).

See Laurence Arnold, “Less Populated States Receive More Money per Capita for

(continued...)

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near a major city is less likely due to the higher probability that such an event would

be noticed by officials or citizens.32

Some feel that the existence of bioterrorism countermeasures can themselves

serve as a deterrent to the use of these agents. In theory, the BioWatch program

might have this effect, with potential bioterrorists knowing that cities have early

warning capability due to the BioWatch program being deterred from using

biological weapons. Some may conclude that this deterrent value is enhanced by the

general secrecy surrounding BioWatch program details, such as monitor locations

and pathogen lists. The deterrence value may be difficult to measure, and may

alternately direct terrorists toward locations lacking such detectors. Also, the general

secrecy surrounding the BioWatch program details may lead potential bioterrorists

to underestimate the system’s true capability, decreasing the deterrent effect.

Sensor Siting Issues

Technical issues regarding placement of BioWatch monitors are raised as

potential limitations to the system’s effectiveness. Some BioWatch monitors are

reportedly co-located with preexisting EPA air quality monitors,33 though potentially

the monitors could be relocated should the need arise.34 Regulations regarding

placement of EPA air quality monitors are found at 40 CFR 58, and, among other

criteria, placement is designed to assess the impact of potential pollutant sources for

a given area. Since these criteria are different from those designed for biological

detection, the placement of the EPA air quality monitors may not place the BioWatch

monitors in an optimal configuration for a given area. Some outdoor pathogen

releases, particularly those that might be small, reportedly might avoid detection due

to gaps or limitations in coverage due to siting, even though the monitors themselves

were very sensitive.35

The exact locations of the BioWatch monitors are not public knowledge. The

Department of Homeland Security does not confirm the locations of BioWatch

monitors.36 If the locations of these monitors were known with great certainty, it

might become possible to avoid them, to degrade their detection capability, or to

provide them false signals or information. The locations of the BioWatch monitors

(...continued)

Security,” The Associated Press, June 29, 2003.

“San Diego Monitored By Bioterror Sensors; Experts Question Effectiveness,” NBC San

Diego, July 10, 2003.

Doug Tsuruoka, “Web Is Key Homeland Security Element – A Revamp of Civil Defense,”

Investor’s Business Daily, February 20, 2003, p. A10.

Dan McKay, “Is Our Air Toxic?” Albuquerque Journal, July 3, 2002, p. A1.

Stacy Finz and Alan Gathright, “S.F.’s Bio-Warfare Sentries; City Marshals Devices to

Give Early Warning of Anthrax, Smallpox Attacks,” The San Francisco Chronicle, April

3, 2003, p. A14.

Geoff Dutton, “Ohio Says Security Requires Secrecy On Tests For Air Toxins,” The

Columbus Dispatch, March 21, 2003, p. 3A.

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determine the detection coverage areas and the security of the monitors. Some law

enforcement concerns which may have been employed in developing priorities for

placing and operating BioWatch monitors include: assuring the physical security of

the monitors so that no tampering occurs; guaranteeing that monitor filters arrive at

the testing location in the same condition as when they were removed from the

monitor; and providing that the chain of custody for potential forensic evidence is

established.

A further concern regarding placement of some BioWatch monitors near EPA

air quality sites is that EPA monitors are not equally spaced within a city or an area.

Even if the EPA monitors meet the above criteria with respect to security, privacy,

and access, the irregularity of placement and potential gaps in coverage between

these sites may cause them to be not entirely appropriate as BioWatch monitors. It

is suggested by some that an outdoor biological warning system would require the

placement of monitors as closely spaced as 300-500 meters.37 Neither the official

rationale for BioWatch monitor placement nor who established the placement criteria

has been disclosed. It may be that the reported choice of sites reflects an effort to

provide maximal coverage for the population in a particular metropolitan area. An

unnamed spokesman for the Department of Health and Human Services stated that

the goal of BioWatch siting is to provide coverage for 80% of the population of a

particular area.38 Alternately, cost and ease of access are suggested as possible

additional reasons for the reported use of EPA co-locations.39

Following a positive signal from a BioWatch monitor, the likely affected area

might be determined through analysis and modeling of potential releases. Those

determined to be inside areas affected by the release might receive priority treatment.

A recent Congressional hearing40 cast light on the diversity of programs able to

model gaseous releases, but also highlighted that there is not a single, acknowledged

best method for determining the area of effect of a given release, especially in urban

areas where wind patterns and the effects of turbulence from building geometries is

only partially known.41 Thus, determining the exact areas impacted by the release,

See Gary Eifried, “Detecting Biological Terrorism; Evaluating the Technologies,” in The

Role of Biotechnology in Countering BTW Agents, A. Kelle, et al., Eds. (Kluwer Academic

Publishers) 2001, and Philip J. Wyatt, “Early Warning and Remediation: Minimizing the

Threat of Bioterrorism,” Journal of Homeland Security, April 2002, found online at

[http://www.homelandsecurity.org/journal/Articles/wyattearlywarning.htm].

“BioWatch Program Aims For Nationwide Detection of Airborne Pathogens,” CIDRAP

News, February 26, 2003, revised March 10, 2003.

Ian Hoffman, “Air Monitors To Sniff For Biowarfare Agents,” The Oakland Tribune,

January 24, 2003.

U.S. House of Representatives, Committee on Government Reform, Subcommittee on

National Security, Emerging Threats and International Relations, Following Toxic Clouds:

Science and Assumptions in Plume Modeling, 108th Congress, June 2, 2003.

For a representative view, see National Research Council, Tracking and Predicting the

Atmospheric Dispersion of Hazardous Material Releases: Implications for Homeland

Security, (Washington, DC: National Academies Press) 2003.

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and hence those individuals requiring priority treatment, may be more difficult if the

monitors are sub-optimally deployed.

Analytical Issues

As stated above, the BioWatch Program is built from the successes of BASIS,

developed by the Department of Energy.42 BASIS, which employs similar

technology, was tested by the Department of Energy in a variety of situations,

including laboratory environments and deployment at the Salt Lake City Winter

Olympics in 2002.43 It is not fully known what potential changes were made to the

BASIS equipment when it was adapted to serve BioWatch, and how applicable

previous testing results for BASIS are to BioWatch. Some question the ability of the

BioWatch test methods to detect pathogens in a large city environment, especially

one with considerable pollution and airborne particulate matter that might affect

analysis.44

Some are concerned that there may be naturally-occurring background levels of

some pathogens in surveyed cities, leading to positive findings in the BioWatch

program which do not result from bioterrorism.45 While PCR is a sensitive

technique, it reports the presence or absence of a DNA sequence, providing only a

coarse scale of the amount of initial material. The diseases caused by anthrax,

plague, and tularemia bacteria, all on CDC’s Category A list of biological terrorism

agents, are not commonly found in humans, but they are diagnosed as naturallyoccurring infections each year in the U.S.46 Certain of these agents are considered

endemic, regularly present in the environment, in certain parts of the country. The

BioWatch Program appears to be premised upon the assumption that all positive

detections merit further investigation, even if there may be a detectable background

level of these pathogens in some areas. In this regard, the BioWatch Program is a

simpler methodological design than surveillance systems that detect deviations from

an anticipated background event level. Such systems have the added burden of

determining thresholds above background which are significant. Those concerned

about detection of naturally occurring background pathogens question how response

The General Accounting Office, for example, states that BASIS was adapted to process

samples from the BioWatch program. United States General Accounting Office,

Bioterrorism: Information Technology Strategy Could Strengthen Federal Agencies’ Ability

To Respond To Public Health Emergencies, GAO-03-139, May 2003. See also Vin

LoPresti, op cit.

Statement of Mary Anne Yates, Senior Advisor, Threat Reduction, Los Alamos National

Laboratory before the New Mexico Legislature, Committee on Information Technology

Oversight, September 18, 2002.

For example, see Mark Baard, “Bio-Whatchamacallit,” The Village Voice, March 12-18,

2003.

David B. Caruso, op cit.

Centers for Disease Control and Prevention, “Biological and Chemical Terrorism:

Strategic Plan for Preparedness and Response: Recommendations of the CDC Strategic

Planning Workgroup,” Morbidity and Mortality Weekly Report, Vol. 49 (RR04), April 21,

2000.

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plans might take this possibility into account. When airborne tularemia bacteria was

detected by BioWatch sensors in Houston, Texas, other information, such as the

appearance of human illness, was sought to clarify the BioWatch result.

Further concerns with BioWatch implementation relate to the verification of

positive results and the use of further testing to guide governmental response. While

the number of false positives arising with BASIS was determined to be very small,47

it is unknown whether that rate is directly applicable to BioWatch equipment. The

BioWatch collection filters, under vacuum airflow for several hours, have the

potential to dessicate and kill organisms collected on them, yielding positive PCR

results that cannot be directly confirmed by growth of a pathogen in culture.48 PCR

methods are based on the detection of DNA signatures; they do not require that the

organisms be viable, nor do they distinguish whether organisms are viable or not.

For many pathogens of bioterrorism concern, the “gold standard” confirmatory test

is based on growth of the sample in culture. Besides providing clear confirmation

of preliminary results, growing the organism provides options for further testing. For

example, having viable samples of the pathogen allows for molecular

“fingerprinting” and other techniques to support epidemiologic and law enforcement

investigations, as well as allowing determination of antibiotic resistance. There may

be analytical techniques, other than culture, used to clarify PCR results from

BioWatch, and other activities that could be undertaken to corroborate initial

findings, but whether protocols for these activities are established and communicated

to the state and local authorities that would implement them is not publicly known.

The public health testing model for bioterrorism, in place during the anthrax

attacks of 2001, incorporates confirmatory testing as one of its operational

cornerstones. LRN laboratories use trained personnel to expedite testing that

confirms or refutes preliminary findings. One goal of the LRN is to minimize the

time between an initial signal, such as a “positive” on a field-screening device that

is expected to yield some false positive findings, and a confirmed result. This

process is designed to launch a public health response swiftly when it is needed, and

avoid doing so when it is not. A large-scale aerosol release of biological agents

would necessitate a public health emergency response of the highest order. While the

BioWatch program is designed to detect a potential aerosol release quickly, if

confirmatory testing is not available, it could lead to triggering response activities

erroneously, potentially consuming limited resources and damaging public

confidence.

A final concern is the threshold for pathogen detection in the BioWatch system.

Since PCR can amplify very small amounts of DNA, such a system could be very

sensitive, theoretically able to detect a single pathogen. On the other hand, the

pathogen deposition onto the filter depends on the rate of air flow into the monitor.

Thus, the pathogen release detection limit is a combination of at least three factors:

the concentration of aerosols passing over the detector; the duration that the aerosol

mist is passing over the detector; and the amount of air collected through the filters

Vin LoPresti, op cit.

“BioWatch Program Aims For Nationwide Detection of Airborne Pathogens,” CIDRAP

News, February 26, 2003, revised March 10, 2003.

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during that time.49 Since these three parameters of equipment performance are not

publicly available, the actual detection limit for BioWatch is not publicly known. As

a consequence, analyst opinion is mixed as to the utility of these monitors, with some

expressing confidence that small releases could be detected, and others expecting that

smaller outdoor releases would fall below the detection limit.50 A very low detection

limit is desirable because for some of the potential agents of bioterrorism, the

infective dose in some individuals may also be very low.51

The BioWatch program is considered labor intensive.52 Collection of filters

from the monitors, processing of the filters, and laboratory analysis all require human

intervention. Additionally, the required laboratory work regularly consumes

chemical reagents and disposable equipment, incurring significant operational cost.

Finally, there are additional costs in administering, overseeing, and managing

personnel and mandatory reporting related to this program. Initial estimates of the

costs of the BioWatch program are reported to be approximately $1 million in initial

equipment costs per city, followed by operational costs of $1 million per city per

year.53 Since the BioWatch Program was launched in January 2003, it is likely that

a more exact accounting of the recurring costs of this program will become available

in the future.

Public Health Response Issues

If an aerosol release of a biological agent were detected, a two-pronged response

would be initiated, with state and local public health agencies in charge of an

epidemiologic investigation, and the Federal Bureau of Investigation (FBI) in charge

of a law enforcement investigation.54 The public health consequence management

plan for the BioWatch program is not publicly available, but based on a generic

model for public health activities following a bioterrorism event, it is likely to

For an overview of issues related to biological weapon detectors see Biological Detection

System Technologies, Technology and Industrial Base Study – A Primer on Biological

Detection Technologies, North American Technology and Industrial Base Organization,

February 2001.

David B. Caruso, op cit.

For example, see T.V. Inglesby, et. al., “Anthrax as a Biological Weapon 2002,” Journal

of the American Medical Association, Vol. 287, No. 17, May 1, 2002, noting evidence from

primate studies that the infective dose of anthrax may be as low as one spore, and D.T

Dennis, et al., “Tularemia as a Biological Weapon,” Journal of the American Medical

Association, Vol. 285, No. 21, June 6, 2001, noting evidence that as few as 10 inhaled

Francisella tularensis organisms may cause disease.

“BioWatch Program Aims For Nationwide Detection of Airborne Pathogens,” CIDRAP

News, February 26, 2003, revised March 10, 2003.

Laura Meckler, “Government Deploys Early Warning System For Bioterror Attack,” The

Associated Press, January 22, 2003. It is likely that this estimate includes salaries for state

public health laboratory workers who perform required sample analysis.

Lawrence O. Gostin, et al., “The Model State Emergency Health Powers Act: Planning for

and Response to Bioterrorism and Naturally Occurring Infectious Diseases,” Journal of the

American Medical Association, Vol. 288, (2002) pp. 622-628.

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include such activities as: expanded laboratory investigation, identification of

affected populations, guidelines for countermeasure distribution, considerations for

management of mass casualties, and potential restriction of movement of individuals

in the case of a communicable agent.55 A likely first step would be aimed at further

sampling to quickly confirm and clarify any positive results from the BioWatch

system, including an attempt to isolate viable organisms, but with an urgency to

minimize the time spent between an initial alert and a decision to launch a public

health response. The public health response to a suspected aerosol pathogen release

is likely to be massive and difficult to implement in a limited manner. It is, in fact,

the intent of the BioWatch program that the public health response be launched as

quickly as possible following a detected release. An often cited theoretical model of

casualties following mass exposure to anthrax concluded that rapid distribution of

antibiotics following detection of the event is a critical element in reducing fatalities,

and could represent a potential bottleneck in the response.56

Another concern is the burden on a public health workforce asked to support a

new program when faced with naturally occurring challenges, such West Nile virus

and Severe Acute Respiratory Syndrome (SARS). At a July 2003 hearing on

biodefense readiness, CDC Director Julie Gerberding noted,

... in the middle of our smallpox program, we did have to take the very same

people and work on a SARS outbreak, and then a monkey-pox outbreak, and now

a West Nile outbreak, and we have a number of very high priorities throughout

CDC and the public health system that compete for the same personnel. ... we

have been in crisis mode for two years now.57

State public health laboratory workers have voiced concern about meeting their

public health duties due to the increase in responsibility for certain federal

programs.58 Similar concerns were voiced about impacts on the public health

infrastructure with respect to smallpox vaccination and terrorism preparedness.59

Since the day-to-day operation of the BioWatch program was transferred to state and

local public health laboratories, the Department of Homeland Security attempted to

mitigate these impacts by providing for hiring of laboratory personnel dedicated to

supporting the BioWatch program.60 Additionally, direct costs of the program,

including consumables such as biological reagents, are provided for by DHS.

Centers for Disease Control and Prevention, The Public Health Response to Biological and

Chemical Terrorism: Interim Planning Guidance for State Public Health Officials, July

2001, available online at

[http://www.bt.cdc.gov/Documents/Planning/PlanningGuidance.PDF].

Lawrence M. Wein, David L. Craft, and Edward H. Kaplan, op cit.

Testimony of Julie L. Gerberding, CDC Director, before the Senate Committee on Health,

Education, Labor, and Pensions Hearing on Federal Biodefense Readiness on July 24, 2003.

Association of Public Health Laboratories, Executive Director’s Note, The APHL Minute,

March-April 2003, available online at [http://www.aphl.org/docs/newsletter/ACF4BA8.pdf].

See, for example, Stephen Smith, “Anthrax vs. The Flu,” The Boston Globe, July 29, 2003.

Michael Lasalandra, op cit.

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Future Directions of the BioWatch Program

Several aspects of the BioWatch Program are undergoing further development.

As stated above, the initial implementation of the system expanded to a reported 31

cities,61 with potentially more areas under surveillance in FY2004.62 This expansion

may lead to efficiencies, and the alleviation of some current concerns, as experience

is gained and problems are solved.

The Department of Homeland Security, through the Science and Technology

Directorate, is also requesting proposals for next-generation detection systems for

biological countermeasures. The Homeland Security Advanced Research Projects

Agency issued Research Announcement 03-01 which requests submissions for

systems able to continuously monitor urban areas for biological agents as well as new

indoor monitoring systems.63

Additional work is being performed at Department of Energy National

Laboratories to complete commercialization of an automated pathogen detection and

analysis capability. This project, called the Autonomous Pathogen Detection System,

would result in a completely automated system.64 The developers expect to have the

ability to measure up to 100 different agents and controls per sample, with low false

positive and false negative rates and a relatively low cost per assay.65

Research and development efforts on other detection systems continue. For

example, the Department of Defense Chemical and Biological Defense Program

continues to develop and deploy technologies for instantaneous detection of

biological and chemical weapons.66 Other prospective technologies include the

SensorNet program, which reportedly is developing a capability to detect chemical,

biological, and radiological dispersion,67 the Urban Atmospheric Observatory,68

David B. Caruso, op cit.

Comments made in “Meeting Minutes,” Centers for Disease Control and Prevention

Information Council, February 27, 2003, found online at

[http://www.cdc.gov/cic/minutes/CIC%20minutes%202-27-03.pdf].

Homeland Security Advanced Research Projects Agency, Detection Systems for Biological

and Chemical Countermeasures; (RA 03-01), Department of Homeland Security, September

23, 2003.

For more information on the Autonomous Pathogen Detection System, see online at

[http://www-pat.llnl.gov/Organization/MDivision/Research/apds.html].

As reported by the company providing the fluidics engine for the Autonomous Pathogen

Detection System, Global FIA, located online at

[http://www.globalfia.com/whatsnew/apds.html].

For an overview of the range of equipment being developed and deployed by the

Department of Defense Chemical and Biological Defense Program, see the Department of

Defense Chemical and Biological Defense Program, Volume 1: Annual Report to Congress,

Annex A, 2003.

Allyson Vaughan, “Making Sense Of Homeland Security,” Wireless Week, July 8, 2002.

(continued...)

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which aims to determine the atmospheric patterns in an urban environment, and

DCNet, a program to map wind currents in the Washington, DC area.69 Such

research may eventually develop the next generation of biological detection

equipment and could provide valuable raw data for analysis of results arising from

the current BioWatch monitors. A better understanding of urban air flow may

provide for a more exact determination of areas affected by an aerosol release.70

Policy Concerns

Many aspects of the BioWatch Program raise policy questions Congress may

consider in the coming months. One question addressed may be whether this

program is an appropriate federal response to the threat of bioterrorism, both in scale

and scope. If it is deemed to be, Congress may be interested in how detection

systems, such as BioWatch and other prototype systems, are being used by the

Department of Homeland Security to increase national security. The BioWatch

Program was deployed rapidly, with little publicity, but lessons learned during this

process may be applicable to other detection systems that the federal government

develops. Congress may also wish to consider how the performance of this system

is measured and determine whether the funding level that the BioWatch Program

receives is appropriate for its performance or effectiveness. Future development of

more advanced monitoring systems and further refinement of the BioWatch monitors

may also be areas of Congressional interest. Another issue is how results from the

BioWatch monitors are integrated into state and federal response plans, especially

since BioWatch is a locally operated, federally funded program.

Significant Role of Detection Systems in DHS Strategy

Distributed detection networks appear to play a significant role in the

Department of Homeland Security’s strategy for protecting the United States. The

Department of Homeland Security’s Directorate of Science and Technology is

establishing a Biological Warning and Incident Characterization (BWIC) system.

BWIC consists in part of environmental monitoring networks in selected cities with

direct agent detection and a nationwide biosurveillance system looking for indicators

of biological agent exposure in people, animals and plants. The DHS Under

(...continued)

For more information, see Oak Ridge National Laboratory, “CBRN Detection &

Defense–SensorNet Fact Sheet,” located online at

[http://www.ornl.gov/~webworks/security/SensorNet.pdf].

Brian Kates, “Tough Job to Sniff Out Terror,” New York Daily News, July 6, 2003, p. 16.

More information on the Urban Atmospheric Observatory is found online at

[http://www.uao.bnl.gov/].

See also Written Testimony of Bruce B. Hicks, Director, Air Resources Laboratory,

National Oceanic and Atmospheric Administration, Department of Commerce, before the

Subcommittee on National Security, Emerging Threat, and International Relations,

Committee on Government Reform, U.S. House of Representatives, June 2, 2003.

Spencer S. Hsu, “Sensors May Track Terror’s Fallout,” The Washington Post, June 2,

2003, p. A1.

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Secretary for Science and Technology McQueary testified that the BWIC system will

be available as a pilot in FY2004.71 The DHS also received FY2004 funds for

programs to develop and demonstrate advanced technologies, including sensors, to

detect radiation using systems distributed over a geographic area.

In the further development of such national-level detection systems, what

features might potentially be addressed, and the priorities assigned to them, is open

to debate. One priority setting decision might be the extent to which the BioWatch

system is further deployed. This decision may prompt additional policy questions.

Will further installation of these systems occur only in metropolitan areas, or will

smaller urban, suburban, and/or rural areas also be eventually included under

BioWatch coverage? Should more monitors be installed in cities currently under

BioWatch, so as to increase the likelihood of detecting a small release? Should

monitors be installed inside buildings or public transportation, where people may be

concentrated? Some experts have criticized the BioWatch program for being

primarily designed to detect large releases while not detecting the potentially more

likely small releases.72 Others point out that during the Salt Lake City Olympics

BASIS was successfully installed in sporting venues and transport hubs where small

releases might be detected.73 On the other hand, deploying multiple sensor units

within a particular area may lead to significant overlap between sensors, providing

diminishing returns per monitor. A complicating factor is the cost of expanding the

BioWatch Program and the increased likelihood of false positives. Since biological

terrorism is often considered to be a low probability/high consequence event, the risk

of an event occurring is balanced against the costs of maintaining the detection

infrastructure necessary to detect the event. Unlike previous investments in public

health preparedness, the BioWatch Program may not have dual-use application, being

predominantly applicable only as an anti-bioterrorism program. Congress may

choose to fund other programs which have greater dual-use application to gain

benefit from such funds if no bioterror event occurs.

Another area of potential interest to Congress may be the method DHS used to

prioritize development and deployment of national monitoring systems. Other

federal agencies have programs to develop biodetectors and monitoring systems.

These systems use a variety of techniques to detect aerosolized pathogens, but have

often contained undesirably high false positive rates or low sensitivity. For example,

the Department of Defense is developing a “stand-off” detection system for some

uses rather than a point detection system, as is employed by DHS in the BioWatch

Program.74 In military settings, the ability to determine whether a threat is posed by

Statement of Under Secretary Charles McQueary, Department of Homeland Security,

before the U.S. Senate Committee on Appropriations, Homeland Security Subcommittee,

April 10, 2003.

David B. Caruso, op cit.

“BioWatch Program Aims For Nationwide Detection of Airborne Pathogens,” CIDRAP

News, February 26, 2003, revised March 10, 2003.

One example of stand-off detection equipment being developed by the Department of

Defense is the Joint Biological Standoff Detection System (JBSDS). For an overview of the

(continued...)

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an aerosol cloud at a distance, allows combat troops to don appropriate gear and

equipment. Also, the Department of Defense focuses on detection systems with realtime detection,75 attempting to develop a “detect-to-warn” rather than a “detect-totreat” capability. These systems provide higher false positive rates than that reported

for BASIS. Because of the ready availability of protective equipment, including

masks and suits, and the high training provided to troops regarding this equipment’s

use, false positives requiring the donning of protective gear are more acceptable than

in a civilian setting. Further research into such technologies and assessment of the

potential performance of these military detector systems when placed in a civilian

environment may be areas for future study. Congress may also wish to consider how

DHS plans to assess the effectiveness and performance of the BioWatch Program.

Since evaluations for homeland security are still being developed, judging the success

of the BioWatch system may prove challenging in the short term.

Deployment of Other DHS Programs

Another issue is whether the deployment of the BioWatch program, using

federal government technologies, government contractors, and providing little

official information with regards to capabilities and locations, is an appropriate

approach to homeland security vulnerabilities. While the deployment of BioWatch

as a federal program may have increased the speed of implementation and thus

enhanced homeland security, a question remains as to whether a more effective,

efficient, or inexpensive system might be developed or deployed if greater public and

commercial input were involved. Other homeland security projects, such as radiation

detectors, were developed and commercialized by engaging competitive market

forces through requests for proposals.76

Evaluating Effectiveness

Frequently expressed concerns about the BioWatch Program are its lack of

ability to detect smaller outdoor releases, its potential for false positives, and its

capabilities in an urban environment. One way to address these concerns is by

disseminating information about performance characteristics of the BioWatch

Program. This type of information is available for other military systems, especially

chemical detectors. For example, the Department of Defense released the detection

(...continued)

Department of Defense chemical and biological detection capability, see Department of

Defense Chemical and Biological Defense Program, Volume 1: Annual Report to Congress,

2003.

For more information about such detection systems, see National Research Council,

Chemical and Biological Terrorism: Research and Development to Improve Civilian

Medical Response, (Washington DC; National Academy Press) 1999.

For example, the Technical Support Working Group holds Broad Agency Announcements

to develop technologies important to members. For more information on the Technical

Support Working Group, see [http://www.tswg.gov/].

CRS-17

levels for some chemical detection equipment,77 and some performance

characteristics, such as false positive rates, are provided for BASIS.78 Even if these

metrics were not publicly disseminated, providing concrete information at the state

and local level might enhance the BioWatch effectiveness. Advantages from early

detection depend on a timely response to a biological release. If state and local

officials lack confidence in the monitor performance, consequence management may

be delayed, leading to greater casualties.79 Alternatively if officials overestimate the

monitor capability, consequence management activities may be engaged even when

there is no need, consuming valuable resources and generating unnecessary public

anxiety. In the case of the BioWatch detection of airborne tularemia in Houston, the

distribution of countermeasures was not begun, pending the collection of additional

information. One option would be to further refine the decision-making process

invoked upon a positive finding to more optimally achieve the goals of rapid

response to a bioterror event.

Determining the effectiveness of the BioWatch Program in achieving its public

health goal, to minimize casualties by detecting exposures more rapidly than would

otherwise have occurred, will be difficult in any circumstances. Assessments of

public health effectiveness are typically considered in the context of opportunity cost;

are allocations of funds and person-hours worthwhile, or might they be better used

elsewhere? BioWatch, designed to detect low-probability/high-consequence events,

is unlike public health surveillance programs, which track conditions expected to

occur in the population. CDC publishes an evaluation protocol for surveillance

systems, “to promote the best use of public health resources through the development

of efficient and effective public health surveillance systems.”80 Information about a

number of the performance characteristics typically described for surveillance

systems – including flexibility, data quality, and representativeness – is not available

to the public for the BioWatch Program. A senior CDC official stated that BioWatch

is in the “proof of concept” phase, a relatively early stage of technology development,

and notes that CDC is, “trying to build systems to assure that once we have true

positives, we can mobilize a response rapidly, but also develop a system for false

positives which we feel could be a potential problem in the future.”81 Efforts to

See, for example, Chemical Casualty Care Division, U.S. Army Medical Research Institute

of Chemical Defense, Medical Management of Chemical Casualties Handbook, 3rd Edition,

July 2000, or National Research Council, Strategies to Protect the Health of Deployed U.S.

Forces; Detecting, Characterizing, and Documenting Exposures, (Washington, DC:

National Academy Press) 2000.

Vin LoPresti, op cit.

Lawrence Wein, a mathematician at Stanford University, reportedly stated that for every

day’s delay before responding to a 1 kg anthrax release 10,000 additional people would die.

Amanda Onion, “Calculating the Unthinkable,” ABCNews.com, March 18, 2003.

Centers for Disease Control and Prevention, “Updated Guidelines for Evaluating Public

Health Surveillance Systems,” Morbidity and Mortality Weekly Report, Vol. 50 (RR13),

July 27, 2001.

Testimony of Joseph Henderson, Associate Director for Terrorism Preparedness and

Response , CDC, before the House Select Committee on Homeland Security, Emergency

(continued...)

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explain the system to those needing to know, and to coordinate the activities of

multiple agencies at the federal, state and local levels, are ongoing.82

The BioWatch Program draws upon the expertise of three federal agencies, the

Department of Homeland Security, the Department of Health and Human Services

(through the CDC), and the Environmental Protection Agency. Which agency is best

suited to provide oversight and evaluation of the BioWatch program is an unresolved

question. DHS funds and currently oversees the program, but some may argue that

the BioWatch Program is inherently a public health program. In this case, the

Department of Health and Human Services, potentially through the CDC, would be

best equipped to assess the effectiveness of the program. The CDC has experience

in federal/state relations regarding public health and in the evaluation of public health

surveillance systems. Also, the CDC may be best qualified to judge the validity of

response and consequence management plans following a BioWatch positive.

Advocates for such a view might point to the retention of bioterrorism-related

civilian countermeasure research and development by HHS, in the Homeland

Security Act (P.L. 107-296), as indicative of the expertise retained within that

Department. Others may assert that the BioWatch Program is a homeland security

program, in which case DHS is the logical choice for sole oversight and assessment

of this program. Since the technologies involved during BioWatch development

originated with elements of DHS, that agency may be uniquely qualified to assess the

state of development and deployment of the system.

Because this program cuts across the expertise of different federal agencies,

oversight and evaluation of the BioWatch Program will likely include the federal

agencies involved. The precedent set in the Homeland Security Act (P.L. 107-296),

where a collaborative approach between the Secretary of Health and Human Services

and the Secretary of Homeland Security is required with respect to civilian human

health-related research and development activities relating to countermeasures for

chemical, biological, radiological, and nuclear and other emerging terrorist threats,83

may be a model for assessment of the BioWatch Program. Determining the relative

authorities of the participating agencies may be an area of Congressional interest.

The Homeland Security Act (P.L. 107-296) also established a Homeland

Security Institute. The Act allows this institute, following a determination by the

Secretary of Homeland Security, to take on the duties of “evaluation of the

effectiveness of measures deployed to enhance the security of institutions, facilities,

and infrastructure that may be terrorist targets,” “assistance for Federal agencies and

departments in establishing testbeds to evaluate the effectiveness of technologies

under development and to assess the appropriateness of such technologies for

deployment,” and “design of metrics and use of those metrics to evaluate the

(...continued)

Prearedness and Response Subcommittee, on September 24, 2003.

Center for Infectious Disease Research and Policy, “CIDRAP Completes Planning

Meetings for BioWatch Program,” undated, available online at

[http://www.cidrap.umn.edu/cidrap/center/mission/articles/bwatch.html].

“Homeland Security Act of 2002,” P.L. 107-296, Sec. 304(a).

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effectiveness of homeland security programs throughout the Federal Government,

including all national laboratories.”84 Some may advocate that such an institute

would provide the necessary mixture of federal, private, and public opinions to fully

evaluate the different components of the BioWatch Program.

Funding for the BioWatch Program

The degree to which DHS should focus its spending on such a program is an

area of potential Congressional interest. The DHS reportedly spent approximately

$40 million in FY2003 on the BioWatch program.85 FY2003 funding for the

BioWatch Program was reprogrammed from part of the $420 million transferred

from the Department of Defense to DHS with the National Bio-Weapons Defense

Analysis Center.86 The $40 million for the BioWatch Program represented 12% of

the $340 million dedicated to Biological Countermeasures in FY2003. For FY2004,

the request for the Biological Countermeasures program was $364 million. Congress

provided $199 million, in addition to $68 million in unexpended FY2003 funds, for

a total of $267 million, and increased the amount dedicated to BioWatch. The

conference report accompanying Appropriations for the Department of Homeland

Security (P.L. 108-90), in the section on Biological Countermeasures, states “an

additional $15,000,000 is provided for the urban monitoring program.”87 According

to the White House, a total of $38 million, or 14% of the Biological Countermeasures

budget, will be spent on the BioWatch Program.88 Whether this focus should

continue, the funding levels for the BioWatch Program, and how high a priority this

specific detection system should be for DHS are areas where Congress may exercise

its oversight role.

Future BioWatch Development Priorities

Several of the technological aspects of the BioWatch Program are areas where

gains may be achieved. Areas where successful upgrades of technology might have

significant benefits include reducing the cost of each BioWatch monitor, both in

initial capital outlay and in daily operational cost, further development of detection

methods for more pathogens, or for genetically modified pathogens, and increasing

the automation of the BioWatch technologies. Improving the current technology

might allow coverage of more people and/or detection of more pathogens for the

current cost. Additionally, research into alternate sensor technologies, such as

“Homeland Security Act of 2002,” P.L. 107-296, Sec. 312 (c) (3), “Homeland Security Act

of 2002,” P.L. 107-296, Sec. 312 (c) (5), and “Homeland Security Act of 2002,” P.L. 107296, Sec. 312 (c) (6) respectively.

Dina Cappiello, “‘BioWatch’ to Sound Alarm; Monitors Screen Air Quality for Bacteria

Attack,” Houston Chronicle, July 29, 2003, p. A11.

Personal Communication, Dr. Parney Albright, Assistant Secretary, Plans, Programs and

Budgets, Department of Homeland Security, September 16, 2003.

Conference Report 108-280, p. 56.

Executive Office of the President, The White House, “FY2004 Budget Fact Sheet,”

October 1, 2003, found online at

[http://www.whitehouse.gov/news/releases/2003/10/20031001-7.html].

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biological assays, laser fluorescence, and other more novel techniques, and topics

such as more efficient collection and analysis tools are currently funded by the

federal government. Inclusion of such advances into BioWatch or other detectors

may be worth consideration.

Coordinating Bioterrorism Testing

The BioWatch Program and the Laboratory Response Network (LRN) share

common goals in providing laboratory support for detecting a bioterrorism event, and

both are deployed in state and local public health laboratories, but important

differences may hamper their effective coordination. The BioWatch Program was

developed by the Department of Energy and EPA and was delivered to state and local

public health laboratories in a near-final state in early 2003.89 It is managed and

funded at the federal level by the Department of Homeland Security, with state and

local public health agencies responsible for on-the-ground management of laboratory

activities and response to positive findings. The LRN, in contrast, was developed by

the CDC, FBI, and state and local health agencies, with the first set of test methods

developed prior to the anthrax mailings of 2001. The LRN is managed and funded

at the federal level by the Department of Health and Human Services through CDC,

and, in a fashion similar to the BioWatch Program, state and local public health

agencies are responsible for on-the-ground management of network assets and

response to positive findings.90 The LRN has the benefit of a longer history as a

civilian public health program, during which time policies, procedures and protocols

have matured.

The BioWatch program shares some operational similarities with the LRN, but

there may be areas in which simultaneous operation of the two systems might prove

difficult. Both systems would likely be in significant use during a bioterrorism event,

and handling large influxes of both BioWatch and environmental samples might

cause competition for limited resources. Conflict might arise in areas including

prioritizing samples for testing (triage), referral testing and data management.91 On

the other hand, close involvement of BioWatch operation and testing with the public

health community may prove to be of benefit in the case of an actual attack. In a fact

Judith Miller, “U.S. Deploying Monitor System For Germ Peril,” The New York Times,

January 22, 2003, p. A1.

For an example of a state’s use of established LRN assets for its own detection and

response activities, see Leslie Tengelson, et al., “Coordinated Response to Reports of

Possible Anthrax Contamination, Idaho, 2001,” Emerging Infectious Diseases, Vol. 8, No.

10, October 2002. See also Julie L. Gerberding, Director, CDC testimony before the House

Appropriations Committee, Subcommittee on Labor, Health and Human Services, and

Education, April 9, 2003, for a recent discussion of CDC’s role in maintaining the Network

and its assets.

See James A. Higgins, et al., “A Field Investigation of Bacillus anthracis Contamination

of U.S. Department of Agriculture and Other Washington, D.C. Buildings During the

Anthrax Attack of October 2001,” Applied and Environmental Microbiology, Vol. 69, No.

1, January 2003. During the anthrax mailings of 2001, the testing backlog from the limited

resources of the LRN forced laboratory workers from the Department of Agriculture to

extend their testing work beyond USDA-owned buildings.

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sheet released at the signing of the FY2004 Homeland Security appropriations bill

(P.L. 108-90), the White House noted that the BioWatch program and the LRN are

both early-detection programs for bioterrorism, and that federal partners, “are

working with state and local officials to implement an effective consequence

management plan that incorporates the BioWatch system.”92

Clarifying Roles and Responsibilities

The BioWatch Program is a federal program, while first responders and some

immediate decision makers are state and local officials. Since the results are

generated from federal equipment operated by federally funded workers in a state or

local public health laboratory, which entity bears ultimate responsibility for the

functioning of the system? What is the chain of authority for BioWatch results?

While it has been reported that states are developing response plans in the case of

BioWatch positives,93 the degree of coordination between federal and state officials,

and the mechanisms of federal assistance to states in such an event, appear unclear

at this point. The response plans developed on a state and local level may have

significant differences in approach, depending on the particular resources available,

leading to inconsistent responses to BioWatch positives. Coordination between

adjacent states, and especially coordination with federal authorities in a potential

multi-state event, is crucial to limiting the public health impact. A variety of

considerations, including means to provide security clearances to essential state and

local personnel so they are fully involved in planning and response activities, remain

to be clarified.94 The Department of Homeland Security is developing an updated

national response plan which will define the roles the various federal agencies will

play in a national emergency.95 Areas of potential Congressional interest include the

specificity of federal guidance to states with respect to results from the BioWatch

program, the coordination and cooperation between federal and state resources

following a BioWatch positive, and the incorporation of BioWatch results into this

national response plan’s implementation.

Executive Office of the President, The White House, “FY2004 Budget Fact Sheet,”

October 1, 2003, found online at

[http://www.whitehouse.gov/news/releases/2003/10/20031001-7.html].

“BioWatch Program Aims For Nationwide Detection of Airborne Pathogens,” CIDRAP

News, February 26, 2003, revised March 10, 2003.

Michael Janofsky, “Intelligence to Be Shared, Ridge Tells Governors,” New York Times,

August 9, 2003, p. A19.

This responsibility was conferred onto the Department of Homeland Security by the

Homeland Security Act of 2002 (P.L. 107-296) in Title V, Section 502.

CRS-22

Conclusion

With early detection and treatment of those exposed to biological weapons,

illness and subsequent fatalities may be minimized, and the presence of BioWatch

in urban areas may serve as an effective deterrent to potential bioterrorists. Some

have questioned the effectiveness of such a system. With a limited number of

monitors within a metropolitan area, these critics question whether potentially more

likely smaller-scale events are detected. Others question whether such a system will

provide dependable results upon which sound decisions are made.

Since much information on BioWatch has not been released to the public, it is

difficult to evaluate criticisms of the system. Many of the technical issues raised may

have been or are being addressed by the Department of Homeland Security.

Agreements on coordination between state and federal authorities may be developed

but not released. Congress, in overseeing the use of limited homeland security

resources, may wish to further assess and oversee the impacts of BioWatch and its

further development.

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