Biosurveillance Technology

Testimony of Tara O'Toole Before the House Subcommittee on Homeland Security Appropriations, on Biosurveillance

Introduction

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 “lab­in-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.