Time Counts: A DHS Briefing on its BioWatch Environmental Sensor Network
Security Blog just received this testimony of Tara O'Toole Before the House Subcommittee on Homeland Security Appropriations, on Biosurveillance. It has been updated last Friday, April 16.
Chairman Price, Ranking Member Rogers, and distinguished
Members of the Committee, thank you for the opportunity to appear before you
today to discuss the important topic of biosurveillance, a term that
encompasses a range of purposes, activities and technologies of critical
importance to U.S. homeland and national security. I am honored to testify
today with my colleague, Dr. Garza, Assistant Secretary for Health Affairs and
Chief Medical Officer. A recent report from the National Academy of Sciences
(NAS), titled BioWatch and Public Health Surveillance: Evaluating Systems for
the Early Detection of Biological Threats, summarized and analyzed current U.S.
capacities to detect, characterize, respond to and recover from covert terror
attacks using biological weapons. My testimony today will focus on the
following topics in biosurveillance, several of which were discussed in the NAS
report:
The role of the BioWatch environmental sensor network within
the broad context of bioterrorism surveillance and response
The DHS Science and Technology (S&T) Directorate’s role
in testing and evaluating the next generation of BioWatch technology (Gen 3)
Recent and current research and development activities
within the S&T Directorate related to bioterrorism detection, response and
recovery
DHS’ BioWatch Program
The first generation BioWatch technology was developed by
the Office of National Laboratories and operated by S&T. In 2003, the
Department of Homeland Security (DHS) deployed these air samplers to major U.S.
cities to enable rapid detection of and response to certain biological
aerosols. Over 30 urban areas are now supplied with BioWatch sensors, and
sensors have also been deployed to select indoor venues and are used to monitor
Events of National Significance, such as the Super Bowl. An expanded deployment
of the same technology in 2005 was referred to as Generation 2 BioWatch. In
2007, BioWatch operations were transferred to OHA.
S&T was the developer of Bio Agent Autonomous Networked
Detector, one of the final candidate technologies for Gen 3 BioWatch detectors,
which are now undergoing testing and evaluation by OHA. Gen 3 BioWatch is
expected to be a much more sophisticated technology, allowing a significant
reduction in the time between a release of a biothreat agent and confirmation
of that release by BioWatch technology.
When DHS was established in 2002, a perceived urgency to
deploy useful - even if imperfect - technologies in the face of potentially
calamitous threats catalyzed rapid fielding of many complex technologies. The
original DHS 2003 deployment of BioWatch sensors was initiated before the
technology was fully tested, and before detailed operational plans were
developed or exercised. As Dr. Garza notes, the Test and Evaluation Division of
S&T is working closely with OHA to oversee rigorous and comprehensive
developmental and operational testing of BioWatch Gen 3, as I will discuss in
detail shortly.
DHS recently implemented Acquisition Directive 102-01, which
institutes a disciplined process for all DHS technology acquisitions, mandating
detailed specification of operational requirements as well as rigorous
developmental and operational testing. Implementation of this Directive is an
important milestone in the maturation of DHS and should promote a more transparent
and cost-effective approach to technology development and deployment across the
department.
One of the key roles of the S&T Directorate is to
oversee testing and evaluation of complex technologies that DHS components are
seeking to acquire. DHS leverages the private sector’s own research investments
in commercial technology against the mission needs of the Department, but we
must exercise appropriate diligence to determine if the technologies work as
anticipated in realistic operational settings. Secretary Napolitano has
instructed me to work closely with the DHS Under Secretary of Management and
with DHS components to ensure that the new Acquisition Directive is implemented
in a manner that encourages a more mature approach to technology investments.
US Biosurveillance is a Complex “System of Systems”
Current BioWatch Sensor Technology
BioWatch sensors are intended to be integrated into a
complex network of environmental monitoring, medical surveillance activities
and public health response, a “system of systems” that serves multiple purposes
and varies significantly among state, local and tribal public health
jurisdictions. As the NAS report describes, and as Dr. Garza notes in his
testimony, determining how best to integrate BioWatch sensors into public
health response is a work in progress, requiring ongoing collaboration,
assessment and readjustment.
As currently operated, BioWatch filters are collected every
24 hours and delivered to local laboratories, where they are analyzed according
to prescribed protocols. If this analysis recognizes one of the five biothreat
agents that the system is designed to detect, it is termed a BioWatch
Actionable Result (BAR). Laboratories report BARs to local public health
officials, who must then decide how to respond. It is possible that a bioattack
would be detected by clinical means, without triggering BioWatch detectors, or
that an attack might use biothreat agents not detectable with current sensors.
The S&T Chemical and Biological Division (CBD) is
responsible for developing highly robust laboratory assays for the rapid
detection of biological pathogens of interest. DHS and the Centers for Disease
Control and Prevention (CDC) are in the process of validating these assays so
that when deployed and employed by the CDC Laboratory Response Network (LRN),
public health officials can be assured that lab results reliably predict the
presence of potential biological agents of interest. S&T is also
collaborating with private sector companies interested in marketing commercial
environmental detectors, to ensure that alarms sounded by such commercial
systems are public safety -actionable and will trigger the immediate response
by CDC LRN to evaluate the samples using public health actionable assay which
is intended to provide the highest level of confidence.
In the event of a bioattack, thousands of samples, collected
both from BioWatch sensors and from the environment, would require lab
analysis. DHS S&T is part of the Integrated Consortium of Laboratory
Networks (ICLN), formed in 2005 to harmonize analytical protocols and to ensure
that results from the wide array of federal, state and private laboratories
involved in evaluating BioWatch samples are comparable. ICLN is addressing such
questions such as how labs would work together to confirm the nature and extent
of contamination following a biological (or chemical or radiological) release.
A spring 2010 exercise is planned to test current procedures.
BioWatch and Public Health Response
While the NAS Committee noted technical, operational and
programmatic challenges associated with current and planned BioWatch systems,
BioWatch has the potential to enable appreciably earlier distribution of
medical countermeasures under certain scenarios, such as an aerosolized anthrax
attack, than would occur using traditional public health and clinical
surveillance methods. The report states:
BioWatch in its current form (Generation 2) or with planned
enhancements (Generation 3) has the potential to fill a unique and
complementary functional niche in the nation’s biosurveillance resources.
However, this potential can be realized only if a large-scale aerosol attack
occurs in a locality where BioWatch is deployed, if an air sampler lies in the
path of the release, and if the pathogen used is one of those included in the
BioWatch laboratory assays….The potential benefit appears likely to be greater
for the detection of anthrax spores than other monitored threat agents…(p12)
The core purpose and intent of BioWatch is to hasten the
public health response to a covert bioattack, allowing rapid distribution of
medical countermeasures, thereby saving lives. However, BioWatch sensors
detecting the release of a biothreat agent does not automatically trigger a
major public health response. The decision to treat a BAR as evidence of a
bioattack could have huge consequences if it were a false alarm, including
destructive impacts on the community’s confidence in the public health system.
As the Committee noted:
There is no simple algorithm to guide decision makers on the
public health response to a major biological threat from the release of a
bioterror agent. The decisions made will hinge on a variety of inputs and
depend heavily on whether the information is sufficient to determine that an
effective release of a bioterrorism agent is likely to have occurred. (p47)
Since 2003, there have been a number of BARs, though none
have been the result of a biological attack. In some BAR cases, BioWatch
samples contained genetic material that was highly similar to that found in
BioWatch target organisms, but which turned out to be from microbes that are
present in the ambient environment but do not represent threats to human
health. Progress has been made in developing lab tests that distinguish these
close relatives of bioweapons threats and work on creating even more specific
lab assays is ongoing.
BioWatch is Complementary to other Approaches to Infectious
Disease Biosurveillance
A central conclusion of the NAS report is that the
environmental detection provided by BioWatch sensors is complementary to other
forms of medical and public health surveillance, including case reporting by
health care professionals, timely laboratory reporting, and rapid,
point-of-care diagnostic testing. The Committee found that state and local
public health agencies have a widely varying capacity to perform surveillance
activities, “leav[ing] the nation with many holes in the ability to promptly
detect, confirm, and respond to disease clusters or bioagents attack.” (p98)
The Committee concludes by emphasizing the essential,
irreplaceable role state and local health departments play in defending the
nation against biological attacks and other infectious disease emergencies and
highlights the reality that “the benefits of even ideal biosurveillance will
not be realized if states and communities do not have the capability to respond
effectively to a public health emergency.” (p155)
Testing and Evaluation of Generation 3 BioWatch
Gen 3 BioWatch
The next evolution of environmental sensor technology, Gen 3
BioWatch, is essentially a “lab in-a-box”. Gen 3 BioWatch would be far more
technologically sophisticated than the current BioWatch sensors, with the
ability to automatically collect outdoor air samples, perform molecular
analysis of the samples and report the results electronically to provide
near-real time reporting. The target requirements for Gen 3 included:
·
reducing the time between sampling and reported
detection from 10-36 hours with Gen 2, to about 4 hours with Gen 3
·
increasing the number of targeted biothreat
agents monitored
·
potentially reducing unit procurement costs down
to $80,000 per detector unit
·
detection sensitivity and false positive rates
must remain at least as good as the current system’s performance
As the BioWatch network is presently planned to expand with
greater capability, this will increase total costs of the BioWatch Gen 3 system
as compared to the current deployed Gen 1/2 system. Along with the considerable
operational complexity of current U.S. biosurveillance systems, it is
imperative that the operational advantages and feasibility of the proposed
system be carefully evaluated and that actual performance of Gen 3 be tested in
realistic field conditions before large technology acquisition investments are
made. S&T and OHA will continue to work collaboratively to conduct and
oversee rigorous developmental and operational tests of the proposed Gen 3
technologies.
S&T Role in Department-wide Test & Evaluation
(T&E)
Section 302 of the Homeland Security Act of 2002 charges
S&T with the responsibility for “coordinating and integrating all research,
development, demonstration, testing, and evaluation activities of the
Department.” To carry out these and other test and evaluation (T&E)-related
legislative mandates, the Directorate established the Test and Evaluation and
Standards Division (TSD) in 2006 and created the position of Director of
Operational Test & Evaluation in 2008.
TSD develops and implements robust Department-wide T&E
policies and procedures. Working with the DHS Under Secretary for Management,
TSD approves Test and Evaluation Master Plans (TEMP) that describe the
necessary Developmental Test and Evaluation (DT&E) and Operational Test and
Evaluation (OT&E) tasks that must be conducted in order to determine system
technical performance and operational effectiveness based upon vetted
Operational Requirements Documents.
OHA has chartered a BioWatch Gen 3 T&E working
integrated product team (WIPT) to develop a robust testing strategy for
BioWatch Gen 3. The team includes staff from OHA, S&T TSD, representatives
from the independent authority conducting the operational tests, and local
jurisdiction BioWatch operators. S&T has worked closely with OHA and the
T&E WIPT to develop the BioWatch Gen 3 TEMP, which provides the overall
T&E strategy for BioWatch Gen 3, including the developmental testing (DT)
and operational testing (OT) requirements as well as resources required during testing.
Prior to the start of each test, the DT test plans will be approved by OHA, and
the OT test plans will be approved by S&T’s Director of Operational
T&E. The projected test schedule is event driven and the test results and
analyses will drive the schedule and subsequent acquisition decisions. Each
phase of testing has identified exit criteria that must be satisfied prior to
moving on to the next phase.
The T&E strategy for BioWatch Gen 3 includes analyses
called for in the NAS report, such as:
Developmental T&E
Developmental testing and evaluation will focus on testing
individual components of the technology at Utah’s Dugway Proving Ground,
Edgewood Chemical Biological Center in Maryland and other qualified labs as
necessary. This phase will include assay validation, characterization testing,
assessment of data collection reliability/availability/maintainability, and
information technology verification and validation.
DT&E field testing of prototype units in a select number
of BioWatch cities will provide realistic operational assessments in indoor and
outdoor environments with representative users from local BioWatch
jurisdictions. This phase of testing will also allow for an assessment of the
BioWatch Gen 3 information technology IT capability. A final assessment prior
to selection of the vendor products will precede a limited production for use
in OT&E.
Operational T&E
OT&E for the production representative units will occur
in several BioWatch jurisdictions. The Department of Defense (DoD) National
Assessment Group (NAG) will lead the OT&E effort. Testing BioWatch Gen 3 in
an operationally accurate environment will take resources; however, these tests
will be able to identify critical issues in system operations before Gen 3 is
deployed. OT&E will also provide the opportunity to empirically and
realistically compare the costs and benefits of BioWatch Gen 3 against
currently fielded systems. BioWatch Gen 3 OT&E will evaluate the system
from agent release to operator notification. OT&E will not measure the
operator or jurisdiction response once an actionable event has been received by
the operator.
Additional S&T Directorate Investments Relevant to
Biosurveillance and Bioresponse
S&T Role in Department-wide Standards
The Office of Standards for the Department is in the S&T
TSD. To coordinate standards for biocountermeasures within DHS, the Office of
Standards has established a Biological Countermeasures Standards Working Group
that is co-chaired by experts from CBD and OHA. This group is working on
several efforts related to performance specifications, sampling methods and
best practices for tools used in biosurveillance. Voluntary Consensus Standards
for microbiological assays are developed by an independent standards
development organization, the AOAC International. Under contracts with Office
of Standards and CBD, AOAC has assembled a panel of experts from multiple
federal and state agencies, national laboratories, manufacturers and first
responders to develop detailed performance specifications for bioassays. These
standards are being incorporated into test methods that will be used in the
BioWatch T&E. S&T is also working with multiple federal partners (e.g.,
CDC, DoD, Environmental Protection Agency, National Institute of Standards and
Technology, and the Federal Bureau of Investigation) to develop standards under
the auspices of ASTM International for sampling materials suspected of being
biological agents.
Detection and Characterization of Bioattacks
From its inception, CBD has taken on the difficult mission
of improving the country’s ability to detect and mitigate the effects of
chemical and biological attacks. These missions have required CBD to undertake
considerable fundamental research, to attempt analysis of complex problems with
many unknowns and to bring new technologies from conception to prototype.
Characterizing Biothreats
A significant CBD responsibility has been the need to better
understand and characterize the bioterrorism risk itself. The Biothreat Risk
Assessment (BTRA), a biannual analysis directed by S&T and mandated by
HSPD-10, assesses the likelihood and consequences of aerosolized attacks of
different biothreat agents on populations. The BTRA uses probabilistic risk
assessment methods and computer modeling to consider a range of possible scenarios
and to estimate the consequent human health and economic impacts.
While the BTRA is not a predictive tool, it does provide
valuable insights into the risk posed by different agents, identifies
significant gaps in scientific knowledge, and informs such decisions as which
biothreat agents should be targeted by BioWatch. The BTRA, along with more
in-depth analyses, is one of the inputs to decisions about which medical
countermeasures should be developed for the Strategic National Stockpile.
Detecting Bioattacks
Responding to an aerosolized bioattack will necessitate many
complex decisions, some of which could be aided with technology. For example,
an immediate concern will be whether the threat agent is resistant to certain
antibiotics. The usual means of answering this question requires several days
of testing. S&T, however, has developed a rapid, Polymerase Chain Reaction
(PCR)-based technology to detect antibiotic susceptibility and has convened an
interagency working group to consider approaches to detection of “advanced
biothreats” – pathogens that have been biologically engineered to bypass
traditional medicines and vaccines or to produce more severe disease.
S&T is also developing a number of other technologies
related to environmental detection of bioweapons agents. These include:
portable bio-detectors for field use by first responders and
U.S. Customs and Border Protection agents
low-cost bio-aerosol sensors to be placed at high-value
targets to act as “bio smoke alarms” to trigger additional testing; and
a multi-application technology platform that would allow a
single environmental sample to be screened for multiple pathogens, employing a
user-friendly assay cartridge that would facilitate transport to and comparable
analyses by different laboratories in the event of a bioattack.
Ensuring Situational Awareness
The responsibility for collecting and interpreting human
health-related data chiefly belongs to state public health agencies and HHS,
but understanding the size and source of a bioattack, and how assets might be
marshaled to save lives and minimize disruption will require information of
many types from many sources. Making sense of these data streams and presenting
decision-makers with realistic and coherent options for action will require
integration and interpretation in near-real time.
In past years, S&T has developed decision-support tools
and other software designed to aid rapid analysis of disparate data and to
allow different audiences to view a common operating picture of available
information. Much of S&T’s work has been done in support of OHA’s National
Biosurveillance Integration Center (NBIC). Human reasoning and collaborative
consultation with subject matter experts remain the foundation of current NBIC
analyses, but software tools can facilitate data exchange and interpretation.
For example:
IN-SPIRE software, developed by the Pacific Northwest
National Lab, can rapidly scan and convey the gist of large sets of unformatted
text in multiple languages, such as technical reports, newswire feeds, etc. The
software clusters similar documents together, displaying common themes and
relationships, allowing analysts to spend more time examining relevant
information rather than sifting through masses of irrelevant documents.
The Biosurveillance Common Operating Picture (BCOP) is a
visual electronic display of data pertinent to current biological events,
trends and activities with potential impacts on
U.S. homeland and national security. BCOP presents users
with a common, easily understandable map-based snapshot.
Post-Anthrax Attack Environmental Sampling and Restoration
Once a bioattack is recognized, a host of questions will
need to be answered to inform decision-making and guide the response. For
example, understanding who was exposed and who is at risk of inhalational
anthrax and thus in need of potentially life-saving antibiotics, will hinge on
understanding the source and scope of the release of the biothreat agent.
Important insight into these issues can be gained from post-attack
environmental sampling and subsequent modeling of the likely path of the
biothreat agent. Other sources of information will include public health
surveillance and epidemiology analyses of the pattern of illness in the
population.
Last year, S&T provided the Interagency Modeling and
Atmospheric Analysis Center (IMAAC) with the capability to receive real-time,
high-resolution meteorological data from existing NOAA radars so that IMAAC can
incorporate these data into more precise models of aerosol dispersion – a
critical step in assessing the probable path of exposure from a bioattack. Such
models will also help guide post-attack environmental sampling.
Bacillus anthraces, the microbe that causes anthrax, is
unique among bioweapons agents because of its ability to remain viable for long
periods in the ambient environment. Thus, long-term contamination of an area
with aerosolized anthrax is a concern, although the health risks associated
with exposure to anthrax spores deposited on the ground and surfaces are not
well understood.
The NAS Committee recommended improvements in environmental
sampling and laboratory methods to be used after a BAR is declared. S&T is
participating in or leading several federal initiatives that address the
technical issues associated with post-bioattack environmental sampling. The
overall goal is to formulate a systems approach to restoration of urban areas
after anthrax attacks. CBD chairs the Validated Sampling Plan Work Group, an
interagency effort to establish the strategy to be followed in the wake of an
aerosolized anthrax attack, using validated sampling methods.
The Work Group has published an externally reviewed guidance
document describing a postattack environmental sampling strategy that reflects
both CDC (human health-related) and EPA (contamination and cleanup-focused)
perspectives. The document is now being revised to make it more user-friendly
and to incorporate scenario-based examples of the principles laid out in the
guidance. The guidance document reflects the precepts of the May 2009 DHS
S&T/EPA effort that produced “Planning Guidance for Recovery Following
Biological Incidents,” which describes how environmental sampling can inform
risk-based clean-up decisions on the local level. S&T has also sponsored
two exercises at Idaho National Laboratory to assess sampling methods and
locations for sample collection.
The scientifically based guidance produced by S&T and
other federal partners is essential to effective detection and post-attack
environmental analysis of biological attacks. But just as ensuring an adequate
public health response to bioattacks depends on maintaining a well-trained and
resourced local public health capacity, establishing the source and scope of a
bioagent’s release and the extent of contamination following attacks is dependent
on maintaining strong state and local laboratory response capacity.
Understanding Potential Bioattacks on Subway Systems
Large, outdoor aerosol attacks using bioagents are not the
only type of bioattacks of concern. Stadium events, transportation hubs and
subway systems are also potential targets of bioattacks. S&T has done
extensive studies to better understand the likely dispersion patterns of an
aerosolized anthrax release in subway systems.
The Washington, D.C., metro system and Boston’s subway
system were the sites of S&T modeling analysis to study what would happen
if anthrax were released in an underground station and what responses might
best minimize contamination and save lives. UK scientists participated in this
analysis and the S&T Directorate has formed a technical working group with
the U.K. and other international partners to share knowledge and provide
technical support during emergencies.
Conclusion
I want to thank Dr. Goldstein and all the members of the NAS Committee for producing a superb report that is already actively shaping DHS thinking on biosurveillance. I believe that the current BioWatch system serves a useful and important national purpose. Dr. Garza and I are committed to subjecting BioWatch Gen 3 technologies to rigorous and comprehensive developmental and operational testing and evaluation before recommending that DHS acquire and deploy such technology.
I greatly appreciate the long-standing commitment this Committee has made to understanding the biothreat and to improving U.S. biodefense. I will do all I can to assist you in your work and promise to work diligently with my colleagues in DHS and across government to improve and expand the science and technology which supports U.S. homeland security. I look forward to answering any questions you may have.