The BioWatch Program: Detection of Bioterrorism

CRS Report for Congress
The BioWatch Program:
Detection of Bioterrorism
November 19, 2003
Dana A. Shea
Analyst in Science and Technology Policy
Resources, Science, and Industry Division
Sarah A. Lister
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
In troduction ......................................................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 of¹
sensors to detect biological attack.” The newly formed Department of Homeland
Security (DHS), is responsible for deploying this network, the BioWatch Program,²
reportedly as part of the Biological Warning and Incident Characterization System.
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 is³
ongoing, with over 30 cities chosen as locations for these sensors.
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.

¹“State of the Union Address,” Executive Office of the President, The White House, January
28, 2003, found online at
[ ht t p: / / www.whi t e house.gov/ news/ r el eases/ 2003/ 01/ 20030128-19.ht ml ] .
²For 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.
³The White House, Progress Report On The Global War On Terrorism, September 2003,
p. 14.

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 functional⁵
concept. According to these reports, aerosol samplers mounted on preexisting EPA
air quality monitoring stations collect air, passing it through filters. These filters are⁶
manually collected at regular, reportedly 24-hour, intervals and are analyzed for
potential biological weapon pathogens using polymerase chain reaction (PCR)⁷
techniques. While filters from the BioWatch program were initially shipped to and
tested at a federal laboratory in California, state and local public health laboratories⁸
now perform the analyses. News reports suggest that the system tests for the

⁴Directorate of Intelligence, Central Intelligence Agency, Terrorist CBRN: Materials and
Effects, June, 2003.
⁵For 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.

⁶This 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.

⁷PCR 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.
⁸See Michael Lasalandra, “Boston Joins National Bio-warfare Alert Network,” Boston
(continued...)

pathogens that cause anthrax, smallpox, plague, and tularemia (a bacterial illness,
sometimes called “rabbit fever”), but the entire list of pathogens is not publicly
avai l abl e.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.

⁸ (...continued)
Herald, March 14, 2003, p. 5.
⁹ Ibid.
¹⁰City 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.
¹¹David B. Caruso, op cit.
¹²Comments made in “Meeting Minutes,” CDC Information Council, February 27, 2003,
found online at
[ ht t p: / / www.cdc.gov/ ci c/ mi nut es/ CIC% 20mi nut es% 202-27-03.pdf ] .
¹³“Nationwide Monitoring System Planned For Detecting Bioterror Attack,” The Asssociated
Press, January 22, 2003.
¹⁴“BioWatch Program Aims For Nationwide Detection of Airborne Pathogens,” CIDRAP
News, February 26, 2003, revised March 10, 2003.
¹⁵For 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...)

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

¹⁵(...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.

¹⁶Vin 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.
¹⁷“Technology Will Be Used at 2002 Winter Olympics,” Newsline, February 8, 2002.
¹⁸A 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.
¹⁹Test 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.
²⁰Houston Department of Health and Human Services, “Officials Following Up on Bacteria
Detection,” Press Release, October 9, 2003, found online at
[ ht t p: / / www.ci .houst on.t x.us/ depar t me/ heal t h/ bact e r i a% 20det ect i on.ht m] .

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,²³
who would use them without the least hesitation.
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

²¹Ibid.
²²See 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.
²³“State of the Union Address,” Executive Office of the President, The White House,
January 28, 2003, found online at
[ ht t p: / / www.whi t e house.gov/ news/ r el eases/ 2003/ 01/ 20030128-19.ht ml ] .
²⁴For 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.
²⁵A “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...)

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

²⁵(...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.
²⁶Lawrence 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.
²⁷For 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.
²⁸Julie Deardorff, “City’s Air Monitored for Bioterror Attack: Early Detection System
Criticized,” Chicago Tribune, April 6, 2003, p. C1.
²⁹For 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.
³⁰For 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 byAudrey Kurth Cronin.
³¹See Laurence Arnold, “Less Populated States Receive More Money per Capita for
(continued...)

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

³¹(...continued)
Security,” The Associated Press, June 29, 2003.
³²“San Diego Monitored By Bioterror Sensors; Experts Question Effectiveness,” NBC San
Diego, July 10, 2003.
³³Doug Tsuruoka, “Web Is Key Homeland Security Element – A Revamp of Civil Defense,”
Investor’s Business Daily, February 20, 2003, p. A10.
³⁴Dan McKay, “Is Our Air Toxic?” Albuquerque Journal, July 3, 2002, p. A1.
³⁵Stacy 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.

³⁶Geoff Dutton, “Ohio Says Security Requires Secrecy On Tests For Air Toxins,” The
Columbus Dispatch, March 21, 2003, p. 3A.

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,

³⁷See 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/ j ournal/Articles/wyattearlywarning.htm] .
³⁸“BioWatch Program Aims For Nationwide Detection of Airborne Pathogens,” CIDRAP
News, February 26, 2003, revised March 10, 2003.
³⁹Ian Hoffman, “Air Monitors To Sniff For Biowarfare Agents,” The Oakland Tribune,
January 24, 2003.
⁴⁰U.S. House of Representatives, Committee on Government Reform, Subcommittee on
National Security, Emerging Threats and International Relations, Following Toxic Clouds:^th
Science and Assumptions in Plume Modeling, 108 Congress, June 2, 2003.
⁴¹For 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.

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
anal ys i s .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 naturally-
occurring 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

⁴²The 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.
⁴³Statement 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.
⁴⁴For example, see Mark Baard, “Bio-Whatchamacallit,” The Village Voice, March 12-18,

2003.

⁴⁵David B. Caruso, op cit.
⁴⁶Centers 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.

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

⁴⁷Vin LoPresti, op cit.
⁴⁸“BioWatch Program Aims For Nationwide Detection of Airborne Pathogens,” CIDRAP
News, February 26, 2003, revised March 10, 2003.

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

⁴⁹For 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.
⁵⁰David B. Caruso, op cit.
⁵¹For 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.
⁵²“BioWatch Program Aims For Nationwide Detection of Airborne Pathogens,” CIDRAP
News, February 26, 2003, revised March 10, 2003.
⁵³Laura 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.
⁵⁴Lawrence 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.

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. ... we⁵⁷
have been in crisis mode for two years now.
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.

⁵⁵Centers 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].
⁵⁶Lawrence M. Wein, David L. Craft, and Edward H. Kaplan, op cit.
⁵⁷Testimony 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.
⁵⁸Association 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].
⁵⁹See, for example, Stephen Smith, “Anthrax vs. The Flu,” The Boston Globe, July 29, 2003.
⁶⁰Michael Lasalandra, op cit.

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 new⁶³
indoor monitoring systems.
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 of⁶⁶
biological and chemical weapons. Other prospective technologies include the
SensorNet program, which reportedly is developing a capability to detect chemical,⁶⁷⁶⁸

biological, and radiological dispersion, the Urban Atmospheric Observatory,
⁶¹David B. Caruso, op cit.
⁶²Comments made in “Meeting Minutes,” Centers for Disease Control and Prevention
Information Council, February 27, 2003, found online at
[ ht t p: / / www.cdc.gov/ ci c/ mi nut es/ CIC% 20mi nut es% 202-27-03.pdf ] .
⁶³Homeland Security Advanced Research Projects Agency, Detection Systems for Biological
and Chemical Countermeasures; (RA 03-01), Department of Homeland Security, September

23, 2003.

⁶⁴For more information on the Autonomous Pathogen Detection System, see online at
[ h t t p : / / www-pa t . l l n l . go v/ Or ga ni za t i on/ M Di vi s i on/ Re s e a r c h / a pds .ht ml ] .
⁶⁵As reported by the company providing the fluidics engine for the Autonomous Pathogen
Detection System, Global FIA, located online at
[ h t t p : / / www.gl oba l f i a .c om/ wha t s ne w/ a pds .ht ml ] .
⁶⁶For 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.
⁶⁷Allyson Vaughan, “Making Sense Of Homeland Security,” Wireless Week, July 8, 2002.
(continued...)

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

⁶⁷(...continued)
For more information, see Oak Ridge National Laboratory, “CBRN Detection &
Defense–SensorNet Fact Sheet,” located online at
[http://www.ornl.gov/~webwor ks/security/SensorNet.pdf].
⁶⁸Brian 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/].
⁶⁹See 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.
⁷⁰Spencer S. Hsu, “Sensors May Track Terror’s Fallout,” The Washington Post, June 2,

2003, p. A1.

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

⁷¹Statement of Under Secretary Charles McQueary, Department of Homeland Security,
before the U.S. Senate Committee on Appropriations, Homeland Security Subcommittee,
April 10, 2003.
⁷²David B. Caruso, op cit.
⁷³“BioWatch Program Aims For Nationwide Detection of Airborne Pathogens,” CIDRAP
News, February 26, 2003, revised March 10, 2003.
⁷⁴One 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...)

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 real-
time detection,⁷⁵ attempting to develop a “detect-to-warn” rather than a “detect-to-
treat” 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

⁷⁴(...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.

⁷⁵For 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.
⁷⁶For 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/].

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

⁷⁷See, for example, Chemical Casualty Care Division, U.S. Army Medical Research Institute
of Chemical Defense, Medical Management of Chemical Casualties Handbook, 3^rd 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.
⁷⁸Vin LoPresti, op cit.
⁷⁹Lawrence 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.
⁸⁰Centers for Disease Control and Prevention, “Updated Guidelines for Evaluating Public
Health Surveillance Systems,” Morbidity and Mortality Weekly Report, Vol. 50 (RR13),
July 27, 2001.
⁸¹Testimony of Joseph Henderson, Associate Director for Terrorism Preparedness and
Response , CDC, before the House Select Committee on Homeland Security, Emergency
(continued...)

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

⁸¹(...continued)
Prearedness and Response Subcommittee, on September 24, 2003.
⁸²Center for Infectious Disease Research and Policy, “CIDRAP Completes Planning
Meetings for BioWatch Program,” undated, available online at
[ ht t p: / / www.ci dr ap.umn.edu/ ci dr ap/ c ent e r / mi ssi on/ ar t i c l e s/ bwat ch.ht ml ] .
⁸³“Homeland Security Act of 2002,” P.L. 107-296, Sec. 304(a).

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

⁸⁴“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. 107-

296, Sec. 312 (c) (6) respectively.

⁸⁵Dina Cappiello, “‘BioWatch’ to Sound Alarm; Monitors Screen Air Quality for Bacteria
Attack,” Houston Chronicle, July 29, 2003, p. A11.
⁸⁶Personal Communication, Dr. Parney Albright, Assistant Secretary, Plans, Programs and
Budgets, Department of Homeland Security, September 16, 2003.
⁸⁷Conference Report 108-280, p. 56.
⁸⁸Executive Office of the President, The White House, “FY2004 Budget Fact Sheet,”
October 1, 2003, found online at
[ ht t p: / / www.whi t e house.gov/ news/ r el eases/ 2003/ 10/ 20031001-7.ht ml ] .

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

⁸⁹ Judith Miller, “U.S. Deploying Monitor System For Germ Peril,” The New York Times,
January 22, 2003, p. A1.
⁹⁰For 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.
⁹¹See 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.

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.

⁹²Executive Office of the President, The White House, “FY2004 Budget Fact Sheet,”
October 1, 2003, found online at
[ ht t p: / / www.whi t e house.gov/ news/ r el eases/ 2003/ 10/ 20031001-7.ht ml ] .
⁹³“BioWatch Program Aims For Nationwide Detection of Airborne Pathogens,” CIDRAP
News, February 26, 2003, revised March 10, 2003.
⁹⁴Michael Janofsky, “Intelligence to Be Shared, Ridge Tells Governors,” New York Times,
August 9, 2003, p. A19.
⁹⁵This 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.

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.