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Introduction
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In 2001 the United States experienced the effects of bioterrorism firsthand when envelopes containing anthrax spores were sent through the U.S. Postal Service to several recipients, including two U.S. senators. In addition to the 5 deaths and 17 cases of anthrax infection that resulted, there were substantial economic costs and significant operational challenges in public health and health care, from the federal level down to the community level (Gursky et al., 2003). Partially in response to this incident, President George W. Bush in his 2003 State of the Union address announced that the federal government was “deploying the nation’s first early warning network of sensors to detect biological attack” as one component of a new biodefense program (Shea and Lister, 2003). This network of early warning sensors is known as the BioWatch program.

The BioWatch program, funded and overseen by the Department of Homeland Security (DHS), has three main elements—sampling, analysis, and response—each coordinated by different agencies. 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 and 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

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1The planning committee’s role was limited to planning the workshop, and the workshop summary has been prepared by the workshop rapporteurs as a factual summary of what occurred at the workshop. Statements, recommendations, and opinions expressed are those of individual presenters and participants and are not necessarily endorsed or verified by the Institute of Medicine or the National Research Council, and they should not be construed as reflecting any group consensus.



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1 Introduction1 In 2001 the United States experienced the effects of bioterrorism firsthand when envelopes containing anthrax spores were sent through the U.S. Postal Service to several recipients, including two U.S. senators. In addition to the 5 deaths and 17 cases of anthrax infection that resulted, there were substantial economic costs and significant operational chal- lenges in public health and health care, from the federal level down to the community level (Gursky et al., 2003). Partially in response to this inci- dent, President George W. Bush in his 2003 State of the Union address announced that the federal government was “deploying the nation’s first early warning network of sensors to detect biological attack” as one component of a new biodefense program (Shea and Lister, 2003). This network of early warning sensors is known as the BioWatch program. The BioWatch program, funded and overseen by the Department of Homeland Security (DHS), has three main elements—sampling, analy- sis, and response—each coordinated by different agencies. The Envi- ronmental Protection Agency (EPA) maintains the sampling com- ponent, the sensors that collect airborne particles. The Centers for Dis- ease Control and Prevention (CDC) coordinates analysis and 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 1 The planning committee’s role was limited to planning the workshop, and the work- shop summary has been prepared by the workshop rapporteurs as a factual summary of what occurred at the workshop. Statements, recommendations, and opinions expressed are those of individual presenters and participants and are not necessarily endorsed or verified by the Institute of Medicine or the National Research Council, and they should not be construed as reflecting any group consensus. 1

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2 TECHNOLOGIES TO ENABLE AUTONOMOUS DETECTION FOR BIOWATCH Investigation (FBI) is designated as the lead agency for the law en- forcement response if a bioterrorism event is detected. (Shea and Lister, 2003) In 2003 DHS deployed the first generation of BioWatch air samplers. The current version of this technology, referred to as Generation 2.0, re- quires daily manual collection and testing of air filters from each moni- tor. DHS has also considered newer automated technologies (Generation 2.5 and Generation 3.0), which have the potential to produce results more quickly, at a lower cost, and for a greater number of threat agents (IOM and NRC, 2009). In response to a request from DHS, the Institute of Medicine (IOM) and the National Research Council (NRC) hosted a 2-day workshop that explored alternative cost-effective systems that would meet the require- ments for a BioWatch Generation 3.0 autonomous detection system, or autonomous detector, for aerosolized agents (see Box 1-1 for the state- ment of task). This workshop, which took place June 25–26, 2013, in Washington, DC, was held under the aegis of the IOM Standing Com- mittee on Health Threats Resilience, which assists the Office of Health Affairs (OHA) in DHS on a variety of issues related to its mission, in- cluding administration of the National Biosurveillance Center and the BioWatch program. Although the IOM and the NRC may be asked to examine other issues regarding BioWatch, the focus of this particular workshop was highly circumscribed, as was explained by William Raub, retired science advisor to the Secretary of the Department of Health and Human Services (HHS) and chair of the workshop planning committee, in his opening remarks. Raub further explained that the workshop was organized to examine the use of four classes of technologies—nucleic- acid signatures, protein signatures, genomic sequencing, and mass spectrometry—that could reach technology readiness level (TRL) 6-plus (in which the technology has been validated and is ready to be tested in a relevant environment [see Appendix E for TRL definitions]) over three different tiers of time frames: technologies that could be TRL 6-plus ready as part of an integrated system by 2016, those that are likely to be ready in the period 2016 to 2020, and those that are not likely to be ready until after 2020. “Our task,” Raub said, “is to look at this exciting collec- tion of technologies in various stages of emergence and distill them such that the DHS staff, as they work forward in planning for an autonomous detector, can make selections within the time frames and the many other constraints with which they are faced, not the least of which are budget and other considerations.”

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INTRODUCTION 3 BOX 1-1 Statement of Task The Institute of Medicine will convene an ad hoc committee to organize and plan a public workshop that will explore alternative cost-effective sys- tems that would meet requirements for BioWatch as an automated detection system for aerosolized agents (alternatives to Generation 3). Systems identi- fied need to be capable of being deployed by the Department of Homeland Security by 2018 and enable day-to-day environmental surveillance that would be of value to the public health and medical community. Specifically, the committee will develop the agenda for the workshop and identify and in- vite speakers and discussants to address the following questions:  What are the advantages and disadvantages of alternative cost- effective, flexible, and accurate surveillance systems that could be deployed to ensure that an environmental biothreat is detected as soon as possible, generates a confirmatory response that is accepta- ble to the Centers for Disease Control and Prevention (CDC) and state/local public health officials, and thus optimizes the amount of time available for making the decision to deploy an available medical countermeasure? o Are there specific considerations for indoor vs. outdoor surveil- lance systems?  What would need to be the specifications of a system that would be designed and deployed to enable detection of day-to-day functionality and value to the medical and public health communities to detect common threats (e.g., novel or known viruses, harmful volatile gases, etc.), as well as threat agents identified by through intelligence as- sessments?  What is the current state of technology of biodetection systems using mass spectroscopy, and will the technology be advanced enough by 2018 that it could serve as an alternative to the currently planned pol- ymerase chain reaction (PCR)–based system? o In addition to mass spectroscopy, are there other technologies that may be available to use in place of PCR to enable greater flexibility of the detection system? The committee may commission white papers to help inform discussions at the workshop related to the aforementioned questions. The papers will be made available to workshop participants at the event or in advance. An indi- vidually authored summary of the presentations and discussions at the workshop will be prepared by a designated rapporteur in accordance with institutional guidelines.

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4 TECHNOLOGIES TO ENABLE AUTONOMOUS DETECTION FOR BIOWATCH WORKSHOP SCOPE AND OBJECTIVES This workshop was designed to meet the following objectives:  Develop an understanding of the nature of the biothreat and the role of biodetection.  Discuss the history of the BioWatch program and the draft re- quest for proposals released by DHS for alternative technologies for autonomous detection.  Discuss the role of public health officials and laboratorians in the interpretation of BioWatch data and the information that is need- ed from a system for effective decision making.  Review the current state of the art and explore the potential use of four families of technologies for the BioWatch program: o nucleic-acid signatures detected using polymerase chain re- action (PCR), microarrays, and other probe-based systems; o immunoassays and protein signatures; o genomic sequencing; and o mass spectrometry (MS).  Explore how the technologies discussed might be strategically combined or deployed to optimize their contributions to an effec- tive environmental detection capability. The discussions, which were catalyzed by five white papers commis- sioned by the planning committee (see Appendixes F–J), also considered the deployment of potential technologies over three levels of readiness:  Tier 1: fully autonomous biodetection systems, capable of 24/7/365 unattended outdoor and indoor operation, that will be at a TRL 6-plus by 2016.  Tier 2: similar requirements but will not reach a TRL 6-plus lev- el until sometime between 2016 and 2020.  Tier 3: technologies that have the potential of meeting or exceed- ing the BioWatch requirements, but a fully autonomous, TRL 6- plus system would not be ready for deployment until beyond the 2020 time frame. As Sally Phillips, acting principal deputy assistant secretary of OHA, said in her introductory comments, the goal of the workshop was to help her office “know what’s the right thing to do, what’s the possible thing to

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INTRODUCTION 5 do, and whether we can get there—today, tomorrow, and into the future.” She asked the workshop participants to consider the question, “What should we be reaching for or what’s just within our grasp that we need to carefully consider as we go forward?” She also reminded the workshop participants to remember during their discussions that BioWatch is not just about machines. “This is about states and locals having to make de- cisions about their communities, to save the lives of members of their communities in the best way possible.” ORGANIZATION OF THE SUMMARY This publication summarizes the presentations and discussions that took place during the workshop, highlighting the key lessons presented, practical strategies for technology development, and the needs and op- portunities for improving the BioWatch program. Chapter 2 provides an overview of the BioWatch program as a means of developing an under- standing of the nature of the biothreat and the role of biodetection in countering that threat. Chapter 3 discusses the role and needs of public health officials and laboratorians in interpreting BioWatch results. Chap- ter 4 explores the state of the art and potential use of the four families of technologies being considered for the BioWatch program. Chapter 5 re- views the key themes and points made throughout the workshop and dis- cusses how the four families of technologies might be combined or deployed strategically to optimize their contributions to an effective en- vironmental detection capability.

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