1
Introduction and Background

Surveillance for, detection of, and response to natural or unintentional disease outbreaks are traditional responsibilities of public health authorities, who rely heavily on health care providers and laboratories to provide timely reports on diagnoses and test results. The national security community also has a long history of biosurveillance and response for defense against threats from biological weapons used as agents of warfare or terrorism. Since the 1990s, growing concerns about bioterrorism and potential epidemics of emerging infectious diseases have spurred interest in developing new and better ways to detect biological threats as quickly as possible so that preventive measures or treatment can be started in time to reduce illnesses and deaths.

After the 9/11 attacks and the anthrax letters in 2001, one response to the threat of bioterrorism was the initiation in 2003 of an environmental air monitoring program called BioWatch. Under this program, the Department of Homeland Security (DHS) has deployed hundreds of air samplers in more than 30 major cities, primarily in outdoor locations, to detect the presence of certain pathogens of concern, should any of them be released in aerosolized form. The aim of the BioWatch program is to speed the detection of aerosolized pathogens to help local health officials respond swiftly to a potential bioterrorism emergency.

Implementing the BioWatch program within a few weeks after it was announced in January 2003 required identifying an air sampling device that could be quickly adapted for field use and deployed. It also required determining how many devices would be used, where they would be placed, where and how the samples would be analyzed, and what the daily operat-



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 Introduction and Background S urveillance for, detection of, and response to natural or unintentional disease outbreaks are traditional responsibilities of public health au- thorities, who rely heavily on health care providers and laboratories to provide timely reports on diagnoses and test results. The national secu- rity community also has a long history of biosurveillance and response for defense against threats from biological weapons used as agents of warfare or terrorism. Since the 1990s, growing concerns about bioterrorism and potential epidemics of emerging infectious diseases have spurred interest in developing new and better ways to detect biological threats as quickly as possible so that preventive measures or treatment can be started in time to reduce illnesses and deaths. After the 9/11 attacks and the anthrax letters in 2001, one response to the threat of bioterrorism was the initiation in 2003 of an environmental air monitoring program called BioWatch. Under this program, the Depart- ment of Homeland Security (DHS) has deployed hundreds of air samplers in more than 30 major cities, primarily in outdoor locations, to detect the presence of certain pathogens of concern, should any of them be released in aerosolized form. The aim of the BioWatch program is to speed the detec- tion of aerosolized pathogens to help local health officials respond swiftly to a potential bioterrorism emergency. Implementing the BioWatch program within a few weeks after it was announced in January 2003 required identifying an air sampling device that could be quickly adapted for field use and deployed. It also required determining how many devices would be used, where they would be placed, where and how the samples would be analyzed, and what the daily operat- 

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3 INTROduCTION ANd BACKgROuNd ing procedures would be. Since 2003, DHS has modified several aspects of the BioWatch system by enhancing the air samplers; deploying additional monitoring devices; relocating devices; and revising protocols for routine operations, analyses, and actions following a positive laboratory result. DHS has also been pursuing alternative approaches to sample collection and analysis to respond to a recognized need to produce results more quickly, more frequently, and from more varied locations than is possible with the current system. The BioWatch system is a civilian environmental monitoring component of a much broader domestic biodefense effort that encompasses a variety of activities. These include information gathering and analysis to identify potential threats and the risk they pose, various monitoring and detection activities, public health and law enforcement responses, and programs lead- ing to restoration and recovery (The White House, 2004; FEMA, 2008). Among these activities are efforts being made to strengthen the ability at the local, state, and national levels to detect and respond to infectious disease emergencies of all types.1 The Department of Health and Human Services (HHS) is leading the federal activities with funding and other re- sources to support the development of a more robust capacity within the public health and the health care sectors to recognize unfamiliar illnesses or unusual clusters of cases, effectively assemble essential information to guide decision making, and speed deployment of an appropriate response. Despite improvements since 2001 in the nation’s preparedness to de- tect and respond to bioterrorism or emerging infectious disease threats, some concerns remain. For example, the Government Accountability Of- fice (GAO, 2009) highlighted continuing needs to clarify federal leadership roles and close known gaps in pandemic influenza preparedness plans. Particular concerns about BioWatch include the timeliness, probability, and accuracy of detection using the current system and the maturity of plans for the introduction of a new generation of devices for automated collection, preparation, and analysis of air samples (e.g., O’Toole, 2007a,b; Price, 2008). Another concern is whether the BioWatch system is appropri- ately integrated with other health-related surveillance and response efforts that must be available to act on a BioWatch alert (e.g., O’Toole, 2007b; Downes, 2008; Price, 2008; Lindley, 2009). Because of such concerns, Congress, through the Subcommittee on Homeland Security of the House Appropriations Committee, directed the Office of Health Affairs (OHA) in DHS to engage the National Academies to evaluate the effectiveness of BioWatch, to compare the benefits and costs of the current version of BioWatch with a planned modification, and to 1 Throughout this report, the phrase “federal, state, and local” encompasses territorial and tribal entities.

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 BIOWATCH ANd PuBlIC HEAlTH SuRVEIllANCE compare BioWatch with an enhanced national surveillance system that relies on the health care and public health systems. STUDY CHARGE AND COMMITTEE MEMBERSHIP To carry out this congressionally mandated study, the National Acad- emies convened the Committee on Effectiveness of National Biosurveillance Systems: BioWatch and the Public Health System. The charge from DHS calls for the committee (1) to evaluate the effectiveness of BioWatch, includ- ing a comparison of benefits and costs for the existing program (referred to here as Generation 2) and for a planned “next generation” program that uses new, automated field devices deployed in greater numbers (Genera- tion 3); (2) to assess the costs and benefits of enhanced national surveillance that relies on U.S. hospitals and the U.S. public health sector; and (3) to compare the effectiveness of surveillance activities and tools used by the public health and health care systems to that of the current BioWatch ap- proach. The complete statement of task appears in Box 1-1. Committee members were selected to contribute expertise in areas that include biological threat assessments, evaluation of biological detection systems, environmental monitoring technologies, biological assays, micro- biology, virology, epidemiology, syndromic surveillance, health informa- tion technology, the U.S. public health sector, hospital systems, emergency medicine, laboratory operations, statistical methods, systems engineering, operations research, and economic analysis. The committee met in person five times from July 2008 through Janu- ary 2009 and conferred by conference call several times during the study. The group gathered information from presentations by invited participants at its first three meetings, responses to written requests for information sub- mitted to DHS and the Centers for Disease Control and Prevention (CDC) in HHS, commissioned analyses, and examination of published literature. An interim report, which described the state of the committee’s review but contained no findings or recommendations, was released in February 2009.2 Additional information about the committee’s activities appears in Appendix A. Invited participants at the committee’s meetings included Congressman David Price; representatives of DHS, HHS, and other federal agencies; representatives of state and local health departments; physicians in clinical practice; and researchers from academia and commercial firms who are developing laboratory testing tools. At the committee’s request, the firm Industrial Economics, Incorporated, prepared information on the costs of 2 The interim report is available from the National Academies Press at http://www.nap. edu/catalog.php?record_id=12599.

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 INTROduCTION ANd BACKgROuNd the BioWatch program and of biosurveillance activities in the public health and health care systems. The committee also commissioned Dr. David Buck- eridge of McGill University to perform a simulation analysis to compare the effect of detection methods on the time from release of aerosolized anthrax spores to initiation of treatment. SCOPE OF THE STUDY The committee interpreted its task as assessing current and proposed approaches for detecting serious human disease threats, especially those resulting from bioterrorism. These approaches include (1) aerosol monitor- ing by the BioWatch system, (2) public health case reporting from clinical and laboratory settings, and (3) “syndromic” surveillance programs that aggregate and analyze various types of data that might be available before the diagnosis of the first case (e.g., chief complaints at emergency depart- ment visits, pharmacy sales, absenteeism) to identify unusual patterns that may signal a disease outbreak. National policy emphasizes the importance of surveillance for detection, as quickly as possible, of potentially catastrophic biological threats to the civilian population of the United States in order to have an opportunity to maximize the decisiveness, timeliness, and effectiveness of public health ac- tions to control disease. The National Response Framework (FEMA, 2008, p. 42) defines a catastrophic incident as “any natural or manmade incident, including terrorism, that results in extraordinary levels of mass casualties, damage, or disruption severely affecting the population, infrastructure, envi- ronment, economy, national morale, and/or government functions.” The study considered detection of both deliberately introduced and natu- rally occurring infectious diseases—that is, agents of bioterrorism and sig- nificant emerging infectious diseases such as pandemic influenza and SARS. Detection of bioterrorism received greater attention because it is the purpose of the BioWatch program. The committee recognized that the national se- curity community maintains an active information acquisition and analysis system that focuses on a subset of the infectious disease threat that is related to bioterrorism and biowarfare. The committee also recognized, and empha- sizes in this report, that the health care and public health systems together are intrinsically a funnel through which information about all forms of disease flow, whether related to bioterrorism or not. Tasks the committee considered to be beyond the scope of the study include an evaluation of underlying assumptions about and estimates of the magnitude of (1) the risk of bioterrorism; (2) the risk of bioterrorism relative to other terrorism threats; (3) the risk posed by any one potential bioterrorism agent compared with another; and (4) relative risks from natural versus bioterrorist threats. Also beyond the study’s scope is an examination of the capability at

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 BIOWATCH ANd PuBlIC HEAlTH SuRVEIllANCE BOX 1-1 Statement of Task The Institute of Medicine (IOM) and National Research Council (NRC) will evaluate the effectiveness of BioWatch, including a comparison of benefits and costs for Generations 2 and 3; the costs and benefits of an enhanced national surveillance system that relies on U.S. hospitals and the U.S. public health system will also be assessed, and its effectiveness compared to that of the current BioWatch approach. The evaluation will include examination of the reliability of BioWatch monitoring data and the ability of hospitals and public health officials to respond based on information received from that system. Services under this contract will encompass the evaluation of the ef- fectiveness of both current and enhanced biosurveillance systems to detect biological terrorism or other biothreats to human health, including (1) differ- ing technological generations of BioWatch, (2) current human health-related surveillance systems, including those for zoonotic disease, and (3) describ- ing necessary enhancements to hospital and public health systems based on measures of effectiveness in detecting attacks of bioterrorism or other biothreats. Measures of effectiveness will include the ability of surveillance systems to warn sufficiently to provide effective post-exposure prophylaxis and effective post-infection treatment to affected populations following a bioterrorist attack or other biothreat event. The IOM and the NRC shall provide expert advisors that reflect expertise in relevant fields, such as biological threat assessments, biological detec- tion systems evaluation, environmental monitoring technologies, biological assays, microbiology, virology, epidemiology, health information technology, the U.S. public health system, hospital operations, local emergency manage- ment, public health response, statistical methods, infectious disease mod- eling, syndromic surveillance, systems engineering, operations research, complex database management and analysis; and economic analysis. The following are specific requirements under this requirement. The IOM/NRC shall provide sufficient staff support to organize meetings, generate reports and manage the contract. The IOM/NRC will: the federal, state, and local levels to mount a timely and effective response to the detection of a serious disease threat. Even so, the committee understands that these matters of risk and response capability are critically important to assessing the value of BioWatch and returns to them later in this chapter. The study’s focus on the civilian population in the United States means that the committee, while recognizing the need to monitor and poten-

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 INTROduCTION ANd BACKgROuNd 1. Evaluate the relative merits, and current and potential capabili- ties of the BioWatch monitoring system (Generation 2 and Generation 3) to detect bioterrorist attacks and other biothreats via environmental monitoring, with the aim of early warning and pre-infection prophylaxis and expedited response and recovery. The evaluation will consider both BioWatch Generation 2 and Generation 3 equipment, and the relative advantages and disadvantages of each, including their costs and benefits. 2. Describe the characteristics of an “enhanced national surveil- lance system” that relies on U.S. hospitals and the U.S. public health system. 3. Examine the costs, merits, and capabilities of the current and a potential “enhanced national surveillance system” to provide a basis for a rapid response to bioterrorist attacks or other biothreats, includ- ing initiation of pre-infection prophylaxis and expedited response and recovery. 4. Reach a conclusion as to whether the two systems are redun- dant or complementary, both in current configuration and potential “enhanced” configuration. The analysis shall include a comparison of the effectiveness of the potential “enhanced” national surveillance system with the current and planned BioWatch approach. 5. Prepare an interim report to outline the progress to date on addressing the major issues under consideration by the committee including the types of information that have been collected for assess- ment and any obstacles to addressing items in the task. The interim report will also provide any conclusions reached by that date. 6. Utilize the results obtained in items 1 through 4 to compile a comprehensive final report of the study. The final report shall include all findings and results concerning the effectiveness of BioWatch. The contractor shall present and brief the final report to OHA senior management prior to its public release in prepublication form and dissemination according to the regular practices of the National Acad- emies. The publication process for the final report will be completed following its public release. tially respond to international disease activity, did not examine disease surveillance systems in other countries or ones operated by international organizations. Disease threats to animals and plants per se are also ex- cluded, although these disease threats are very much a part of the broader perspective on bioterrorism (e.g., NRC, 2002; GAO, 2004; The White House, 2004, 2007). Many known infectious disease agents and potential

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8 BIOWATCH ANd PuBlIC HEAlTH SuRVEIllANCE bioterrorism agents are zoonotic; that is, they are animal diseases that can be transmitted to humans. New zoonotic disease threats may also arise as changes occur in the ability of animal diseases to adversely affect human health. As a result, surveillance tools that monitor animal health and the presence of zoonotic pathogens are an important component of surveillance systems that focus on human health. CURRENT FEDERAL FUNDING FOR CIVILIAN ACTIVITIES FOR DEFENSE AGAINST BIOLOGICAL THREATS No consolidated summary of federal funding for civilian activities to defend against bioterrorism and other significant biological threats is di- rectly available from federal budget documents. Past estimates have been compiled from an examination of programs distributed across several de- partments, including DHS, HHS, the Department of Defense (DoD), the Department of Agriculture, and the Environmental Protection Agency (e.g., Franco, 2008). Although the President’s budget for fiscal year (FY) 2010 became available as this report was being completed, aggregated estimates were available only through FY 2009. The estimated FY 2009 total for federal funding for civilian activities to defend against bioterrorism and other significant biological threats was approximately $8.0 billion (Franco, 2008). Of this, $4.2 billion was for activities in HHS and $2.5 billion for DHS. Approximately $2.2 billion of the FY 2009 budget proposal for DHS was for a multiyear allocation for Project BioShield.3 The remaining $1.3 billion of the $8 billion total was to support activities in other agencies. The HHS funding supports activities that range from basic research to operational support for states and communities in national emergencies. This includes the federal funding through CDC for public health surveil- lance activities, the cooperative agreement program to build state and local emergency preparedness capacity, and the Strategic National Stockpile.4 Ex- cluding Project BioShield, the DHS funding includes the BioWatch program in OHA, the National Biosurveillance Integration Center, and research and development activities in the Science and Technology Directorate. Table 1-1 shows appropriated or proposed federal funding from FY 2007 through FY 2010 for specific activities in HHS and DHS. 3 ProjectBioShield was created in 2004 to foster the research, development, and acquisition of medical countermeasures to chemical, biological, radiological, and nuclear (CBRN) threats (HHS, 2008). The program gives the secretary of HHS authority and flexibility to facilitate the research and development for these countermeasures and has a reserve fund for the pro- curement of countermeasures. 4 The Strategic National Stockpile holds vaccines, medications, and medical supplies that can be rapidly deployed to supplement state and local resources in the event of a significant medical emergency.

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 INTROduCTION ANd BACKgROuNd TABLE 1-1 Federal Funding for Selected Civilian Activities to Defend Against Bioterrorism and Other Significant Biological Threats, Fiscal Years 2007–2010 (in millions $) FY 2010 FY 2007 FY 2008 FY 2009 (proposed) Department of Health and Human Services Upgrading state and local $ 767 $ 746 $ 746 $ 761 emergency preparedness capacity BioSense 57 34 34 34 Enhancing the Laboratory Response 10 9 8 8 Network Strategic National Stockpile 496 552 570 596 Department of Homeland Security BioWatch 85 77 112 95 National Biosurveillance 10 8 8 Integration Center NOTE: FY, fiscal year. SOURCES: Franco (2008); CDC (2009a); DHS (2009b). State and local funds also support related activities. The amount of state and local support for disease surveillance and other activities related to bioterrorism is difficult to estimate because these activities are generally carried out as part of a system aimed at detecting and responding to natu- rally occurring diseases. BIOLOGICAL THREATS TO HUMAN HEALTH Potential Bioterrorism Agents Biological agents that might be deliberately introduced in an act of war or bioterrorism include a variety of bacteria, viruses, protozoa, multicellular parasites, and biological toxins. These may be naturally occurring patho- gens or pathogens enhanced to increase their usefulness as bioterrorism agents. Biological agents that are publicly recognized as potentially useful for bioterrorism have been categorized by CDC on the basis of characteris- tics such as their lethality and potential for dissemination (see Box 1-2). The “Category A” agents are a high priority. The agents included in categories B and C are ones that appear to pose serious but more limited risks. Further analysis and delineation of current and future potential bio- terrorism and biowarfare threats is an ongoing activity performed by the

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30 BIOWATCH ANd PuBlIC HEAlTH SuRVEIllANCE BOX 1-2 CDC Categories of Potential Bioterrorism Agents and Their Related Diseases Category A Agents that include organisms that pose a risk to national security be- cause they can be easily disseminated or transmitted from person to person; result in high mortality rates and have the potential for major public health impact; might cause public panic and social disruption; and require special action for public health preparedness. Bacillus anthracis (anthrax) Clostridium botulinum toxin (botulism) Yersinia pestis (plague) Variola major (smallpox) Francisella tularensis (tularemia) Viruses causing hemorrhagic fevers, including �iloviruses (e.g., Ebola, Marburg) �iloviruses (e.g., Ebola, Marburg) Arenaviruses (e.g., �assa, Machupo) Arenaviruses (e.g., �assa, Machupo) Category B Agents that are moderately easy to disseminate; result in moderate mor- bidity rates and low mortality rates; and require specific enhancements of CDC’s diagnostic capacity and enhanced disease surveillance. Brucella species (brucellosis) Epsilon toxin of Clostridium perfringens �ood safety threats, including national security community. In its work, the committee focused on surveil- lance for currently acknowledged bioterrorism threats, especially those ad- dressed by the BioWatch program, but it recognizes the potential for other bioterrorism agents that may pose new surveillance challenges. Because biological agents vary in their physical characteristics and im- pact on human health, no single strategy to defend against bioterrorism is likely to suffice. Inhalation anthrax and botulism, for example, are highly lethal if untreated, but these are not contagious illnesses (i.e., not trans- missible from person to person). Smallpox, caused by the variola major virus, is contagious, but the mortality rate for untreated illness is likely to be much lower than that for inhalation anthrax. Medical options for pre- vention and treatment also vary. Vaccines are available to protect against anthrax and smallpox. Infections with some of these agents are susceptible to antibacterial or antiviral medications, and an antitoxin is available to treat some forms of botulism. However, other illnesses can only be treated

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3 INTROduCTION ANd BACKgROuNd Salmonella species Escherichia coli O157:H7 Shigella species Burkholderia mallei (glanders) Burkholderia pseudomallei (melioidosis) Chlamydia psittaci (psittacosis) Coxiella burnetii (Q fever) Ricin toxin from Ricinus communis (castor beans) Staphylococcal enterotoxin B Rickettsia prowazekii (typhus fever) Viruses causing encephalitis, including Alphaviruses (e.g., Venezuelan equine encephalitis, eastern equine encephalitis, western equine encephalitis) Water safety threats, including Vibrio cholerae (cholera) Cryptosporidium parvum (cryptosporidiosis) Category C Agents that include emerging pathogens that could be engineered for mass dissemination in the future because of availability, ease of produc- tion and dissemination, and potential for high morbidity and mortality rates and major health impact. Emerging infectious agents such as Nipah virus and hantavirus SOURCE: Adapted from CDC (2008a). with supportive therapies (e.g., mechanical ventilation, hydration) that may reduce mortality. In their naturally occurring forms, many of the Category A, B, and C agents are probably poorly suited to the aerosol dispersal that the BioWatch system is designed to detect, but some are naturally stable in the environ- ment (e.g., the spores of Bacillus anthracis) (Sinclair et al., 2008). It is also possible to stabilize aerosolized agents to enhance retention of their infectivity. However, aerosol dispersal is not the only way biological agents might be used. Detection of an alternative dispersal mode would require a means other than BioWatch. For example, BioWatch is not designed to detect dissemination of biological agents through foodstuffs or deployed to detect them through postal delivery. Modern medical and public health experience with many of these bio- logical agents is limited, as is experience with bioterrorism. In 1984, there were 751 known cases of salmonellosis from deliberate contamination of a

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3 BIOWATCH ANd PuBlIC HEAlTH SuRVEIllANCE salad bar but no deaths (Török et al., 1997). The 2001 anthrax letters pro- duced infections in 22 patients, and 5 of these patients died (Jernigan et al., 2002). About 32,000 people who may have been exposed to the anthrax spores received antimicrobial prophylaxis (CDC, 2001a). The committee also noted that the impacts of bioterrorist activities can go far beyond mor- bidity and mortality statistics, as witnessed by the impacts of the anthrax letter attacks. The potential for impacts similar to other national security threats provides the basis for the classification of bioterrorism agents as weapons of mass destruction. Naturally Occurring Infectious Disease Threats Among the potential emerging disease threats, a highly virulent, pan- demic influenza is a leading concern. The appearance of the novel influenza A (H1N1) virus in spring 2009 (as this report was being completed) gave an indication of the serious challenges that are anticipated, not only in manag- ing the delivery of medications and medical care but also in implementing quarantines or other disease containment measures and minimizing the disruption of essential public and private services. The past decade has also seen the emergence of diseases caused by previously unrecognized threats (e.g., the SARS coronavirus) or the sudden appearance in a new environ- ment of unfamiliar pathogens (e.g., West Nile virus or the monkeypox vi- rus). These experiences point to several challenges for timely public health science and practice: distinguishing novel outbreaks from endemic disease, defining diagnostic criteria, identifying the causal agent and its route of transmission, tracking the spread of the disease, and identifying and deploy- ing methods for prevention and treatment. Unusual disease outbreaks may also involve both the national security and public health communities until the origin of the outbreak is determined. While the United States is preparing against the possibility of major infectious disease outbreaks from natural or intentional causes, infectious diseases are routinely responsible for tens of thousands of deaths each year. CDC estimated the infectious disease toll in 2000 at 75,000 deaths, plus ap- proximately 15,000 additional deaths related to HIV/AIDS (Mokdad et al., 2004). In a typical year in the 1990s, as many as 36,000 deaths were related to influenza (Thompson et al., 2003). However, the influenza pandemic of 1918–1919 resulted in an estimated 675,000 deaths in the United States and perhaps as many as 50 million deaths worldwide (HHS, no date). The 2003 SARS epidemic was responsible for 774 reported deaths and 8,098 cases worldwide (WHO, 2004). The United States had 29 reported cases, 8 of which were confirmed by laboratory testing, but no deaths (CDC, 2003). The 2009 novel influenza A (H1N1) epidemic is still under way at the time this report is being finished. As of July 1, 2009, the World Health

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3 BIOWATCH ANd PuBlIC HEAlTH SuRVEIllANCE What Should Be the Focus of Early Detection? A third set of questions concerns the focus of any environmental moni- toring system such as BioWatch. At present, BioWatch is designed to detect a limited number of potential bioterrorism agents, and DHS has proposed increasing this number (DHS, 2009a). Although this expansion may prove feasible, the rationale for selecting additional agents will have to be consid- ered carefully in terms of the bioterrorism risk that any given agent repre- sents, the reduction in poor health outcomes that would be possible with a BioWatch detection, and the potential costs of including additional agents in the monitoring program. An expanded panel of agents may add marginal improvements in bioterrorism detection capacity, but it may also increase the possibility of detecting closely related but nonpathogenic organisms, or even a target agent if it is naturally present in the environment. Unless the technology used to signal the presence of a targeted pathogen is highly selective, an expanded panel may increase the number of questionable alerts that must be investigated by local and state health department personnel and potentially reduce confidence in detection signals. To date, positive test results from BioWatch samples have not been related to bioterrorism. Instead, they have been attributed to the natural presence of microbiologic agents in the environment and have not been associated with recognized increases in human disease. A somewhat similar set of questions can be asked about where Bio- Watch should be used. Will it be most valuable in major cities and admin- istrative centers where population or high-risk targets are concentrated? Do national security concerns and intelligence information support its use in a limited number of specific localities or in specific sites in a locality? The plans for wider use of BioWatch in high-throughput indoor facilities are likely to result in risk-management and cost-effectiveness assessments that are distinctly different from those for the current outdoor deployment. What Are the Trade-Offs Among Detection Approaches? A fourth set of questions might concern trade-offs related to the costs, workforce requirements, and active attention required by a system like BioWatch. With limited financial and personnel resources in state and local health departments to meet day-to-day responsibilities, it may prove chal- lenging to maintain a specialized monitoring system for a low-probability, albeit potentially catastrophic, event. At the federal level as well, there are trade-offs to be made in allocating available resources for the full range of needed biosurveillance activities.

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3 INTROduCTION ANd BACKgROuNd TERMINOLOGY Biosurveillance Homeland Security Presidential Directive (HSPD) 21 (The White House, 2007) defines biosurveillance as “the process of active data-gathering with appropriate analysis and interpretation of biosphere data that might re- late to disease activity and threats to human or animal health—whether infectious, toxic, metabolic, or otherwise, and regardless of intentional or natural origin—in order to achieve early warning of health threats, early detection of health events, and overall situational awareness of disease activity.” The full scope of biosurveillance as defined in HSPD-21 was beyond the scope of this report, which focuses on activities intended to detect threats to human health specifically from pathogens and biological toxins that might be used in bioterrorism or that might be associated with infectious diseases of public health significance. Detection may occur via means including environmental monitoring, clinical case finding, laboratory testing, or syndromic surveillance. Many of these activities are consistent with the long-standing use of the term “surveillance” to describe the process that public health and national security agencies use to monitor trends in diseases or other conditions as part of public health and national security programs (CDC, 2001b; Buehler, 2008). The BioWatch Program and BioWatch System Throughout this report the term “BioWatch program” describes the programmatic activity managed and funded by DHS. In managing the pro- gram, DHS works with other federal agencies and state and local partners. The “BioWatch system” refers to the collection of operational components (which are themselves systems) that produce information from air sampling and feed it into a public health decision-making process to determine the appropriate response to a BioWatch Actionable Result (BAR). Thus, the BioWatch system includes the technology to collect and test air samples, the associated laboratory assays, the additional information gathering needed to confirm and characterize an incident, operational guidance, interagency and risk communication, response planning and exercises, and the person- nel to support these operations, whether or not these activities at federal, state, or local levels are directly funded by DHS. For its goal of minimizing casualties in the event of a bioterrorist attack—the focus of this report—the BioWatch system should be seen as part of a public health approach to identifying disease hazards and mak- ing decisions regarding action to limit the impact of these hazards. Other perspectives are appropriate to assess the contributions that the BioWatch

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38 BIOWATCH ANd PuBlIC HEAlTH SuRVEIllANCE system is intended to make in support of national security, law enforcement, and forensic aspects of detecting and responding to a bioterrorist attack. In addition to DHS’s BioWatch program, the U.S. Postal Service (USPS) and DoD operate their own aerosol monitoring systems. The USPS has de- ployed the automated Biohazard Detection System (BDS) at more than 200 mail processing centers. The BDS collects air samples from mail sorting equip- ment and uses genomic testing specifically for the presence of DNA segments associated with B. anthracis (National Association of Letter Carriers, 2008). DoD has installed outdoor air samplers similar to those used in the BioWatch system at selected military bases in the United States. DoD also uses other technologies, such as lidar and the Joint Biological Standoff Detection Sys- tem, for outdoor monitoring and has installed indoor monitoring systems at certain facilities (DoD, 2007; Mayor et al., 2008). DoD also has worked for many years to develop biodetection technologies to protect against biowarfare threats on the battlefield and in military facilities. The committee received briefings on these systems but does not review them in this report. Other biodetection tools are being developed and offered in the private sector. For example, commercial vendors are offering a variety of handheld biological detection devices intended for use by first responders. Informa- tion about these devices has been compiled for DHS (2007), but systematic testing has not yet been done to establish the reliability and effectiveness of the devices (GAO, 2008b). The Public Health and Health Care “Systems” It is common to refer to the public health “system” or the health care “system,” but in the United States these systems are highly decentralized and only very loosely linked. Neither in public health nor in health care is there an overarching national mechanism for unifying or coordinating the disparate, and often competing, entities involved. Health care is provided by an amalgam of clinicians in individual practice and group settings such as clinics and hospitals. These activities operate as a mix of public, private nonprofit, and for-profit enterprises and are funded by a variety of public and private payers. “Public health” is largely a governmental responsibility, with primary legal responsibility resting with the states, which sometimes delegate this responsibility to local governments. The federal government’s role in public health is extensive, including (but not limited to) leadership in policy development and financial and operational support for research, data collection, and certain services (e.g., vaccine purchase). The organization and operation of public health services is implemented through various configurations of state and local health departments, working with federal agencies, health care providers and organizations, contractors, entities they regulate, and public–private

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3 INTROduCTION ANd BACKgROuNd partnerships. The boundaries between health care and public health services vary and are often vague, with many health departments providing some clinical services and clinicians and health care institutions playing a role in public health functions. In addition, both the health care and public health systems rely on an array of private- and public-sector laboratory services to detect, confirm, and report evidence of infectious disease. CONSIDERATIONS GUIDING THE COMMITTEE’S WORK This report focuses on the committee’s assessment of BioWatch and its relation to infectious disease surveillance through the public health and health care systems for detection of bioterrorist attacks. The effectiveness of each of these approaches is considered on its own merits, without an attempt to assess the merits of other aspects of the preparedness efforts of which each is a part. Even though the full range of preparedness concerns is beyond the scope of this study, three observations require specific note because they are inextricably linked to the committee’s assessments: 1. Systems for surveillance and detection of disease threats need to be accompanied by the capability to respond with appropriate public health or medical measures to minimize illness and death. 2. The BioWatch system is designed to detect certain biological agents that could be intentionally released in aerosolized form, and it operates in a limited number of localities. Detecting a bioterrorism event that relies on other routes of exposure or that involves aerosols released in places where BioWatch detectors are not deployed requires other approaches. 3. There is considerable uncertainty about the likelihood and magni- tude of a biological attack and, as a result, uncertainty about the risk of an aerosolized release of a pathogen. There is also uncertainty about how this risk compares with risks from other potential forms of bioterrorism or from natural diseases. Linking Surveillance and Response Without an effective response capability, good surveillance and detec- tion alone can contribute very little to limiting morbidity and mortality. Therefore, the committee emphasizes, as a fundamental premise, that the capability to effectively deliver public health and health care services, as well as law enforcement and other public services, in response to detected threats is essential. While early warning of an incipient epidemic may have some inherent value, achieving the full benefits of early detection depends on other factors, such as whether exposed people can be provided counter-

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0 BIOWATCH ANd PuBlIC HEAlTH SuRVEIllANCE measures in time to prevent severe illness and whether additional exposure can be prevented by evacuation, limiting the movement of people into contaminated areas, or sheltering in place. It also depends upon whether the agent causes a communicable illness. Meeting the challenges posed by bioterrorism attacks or other large-scale disease outbreaks requires atten- tion to a range of needs, of which effective surveillance and detection sys- tems are only a limited portion. Indeed, there are serious questions about the current capabilities of the U.S. preparedness architecture and how to measure the effectiveness of current preparations (e.g., Nelson et al., 2007; TFAH, 2008, 2009; WMD Commission, 2008). BioWatch Is Not Designed to Be Comprehensive The BioWatch system, as the committee was informed by DHS officials, is specifically designed to detect the presence of certain aerosolized patho- gens that have been released in a quantity that has the potential to infect substantial numbers of people in localities where air samplers have been deployed. Although this capacity addresses some high-priority concerns, the committee also recognizes that these concerns account for a circumscribed set of possible high-consequence terrorist scenarios. Because of the nature of the study charge, the committee has not addressed technologies analo- gous to BioWatch that would be needed to detect other forms of biologi- cal terrorism, such as contamination of food or water or environmental exposure to infectious agents distributed by means that BioWatch is not designed or deployed to detect (e.g., the 2001 anthrax letters). Nor is Bio- Watch designed to accomplish the necessary epidemiologic characterization of disease outbreaks. The health care and public health systems, however, need the capacity to detect and respond both to the health threats posed by the aerosolized pathogens that BioWatch is designed to detect and to the full range of other infectious disease threats. Regardless of how a significant biological threat is detected, the response is likely to require an array of resources, including not only public health and health care but also emer- gency response and law enforcement. Given these fundamental differences in scope among different surveil- lance systems, the committee sought an approach to make comparative assessments. In some cases, the committee made head-to-head compari- sons between BioWatch and other modes of surveillance specifically for an aerosol attack, such as with anthrax spores. In other cases, the committee accepted that no direct comparison was appropriate. Uncertainty About Risk Both bioterrorism agents and emerging infectious diseases are consid- ered health threats for the United States; that is, they have the potential to

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 INTROduCTION ANd BACKgROuNd cause harm (IOM, 2003; Blair, 2009). The existence of the BioWatch pro- gram bears witness to a perceived threat to the nation from the intentional release of aerosolized biological agents. However, knowledge of the exis- tence of a threat is different from an understanding of the likelihood that specific threat events will occur and the consequences they will produce. DHS is charged with conducting biennial risk assessments to “provide the basis for risk-informed investments for national strategic biodefense planning while identifying key knowledge gaps and defining critical vul- nerabilities” (DHS, 2009c). It has produced Bioterrorism Risk Assessment (BTRA) reports in 2006 and 2008. However, a National Academies report presented several concerns about the approach and methodology used in the 2006 DHS risk assessment (NRC, 2008). For this report on BioWatch and biosurveillance through the public health and health care systems, the committee was not tasked to evaluate threat or risk information. For this reason, many of the conclusions of this report are couched in terms of a strongly conditioning assumption, such as, “Given that a particular biological agent, in a given quantity, is released at a specific location, how well would various surveillance systems perform?” The probabilities of such assumptions and the associated consequences are combined in the BTRAs to estimate the “risks.” Although risk assessments are not incorporated in the conclusions reached in this report, the commit- tee is very conscious of the importance of understanding risk in evaluating the decisions to actually implement risk-mitigating strategies such as Bio- Watch and disease surveillance. RELATED ACTIVITIES Because of the salience and evolving nature of the nation’s civilian efforts to defend against bioterrorism and other biological threats, other related activities were under way during the course of this study. Two in particular—one by GAO and another by CDC—proceeded largely in parallel with the work of this committee. The concurrent nature of these activities limited the opportunity for the committee to benefit from their findings. GAO, under Public Law 110-53, Implementing Recommendations of the 9/11 Commission Act of 2007, was charged with preparing a report for Congress on “the state of [f]ederal, [s]tate, local, and tribal government biosurveillance efforts” and making recommendations on integration of biosurveillance systems and the effective use of biosurveillance resources (P.L. 110-53, Sec. 1102). As described to the committee at its first meeting, the GAO has interpreted its task as encompassing all aspects of biosurveil- lance, including activities related to threats to plant and animal health (Jenkins, 2008). In congressional testimony in July 2008, GAO described the DHS plans to introduce new air sampling technology but provided no

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 BIOWATCH ANd PuBlIC HEAlTH SuRVEIllANCE evaluation of those plans or the program as a whole (GAO, 2008a). GAO plans to issue four reports from its review of biosurveillance, with the first two reports expected in summer 2009 (Tapia-Videla, 2009). In mid-2008, CDC was given responsibility for leading the HHS plan- ning and implementation of “an operational national epidemiologic sur- veillance system for human health . . . ,” which was called for under HSPD-21, “Public Health and Medical Preparedness” (The White House, 2007). During much of the time the committee was studying the issues and preparing this report, CDC staff were engaged with numerous contributors from other federal agencies, state and local governments, and the private sector to develop a document laying out a national strategy for biosurveil- lance, including identifying potential enhancements of current systems and capabilities (Sosin, 2008, 2009a). A working document, distributed for comment in December 2008 (CDC, 2008b), identified six strategic priori- ties: (1) electronic health information exchange, (2) electronic laboratory information exchange, (3) unstructured data, (4) integrated biosurveillance information, (5) global disease detection and collaboration, and (6) the biosurveillance workforce of the future. Guidance for continuing develop- ment of the strategy is being provided by CDC’s National Biosurveillance Advisory Subcommittee, which will issue its initial report late in 2009 (Sosin, 2009b). Also ongoing are local, regional, and national efforts to advance the development and adoption of health information technology, including electronic medical records and health information exchanges. The February 2009 federal economic stimulus package (P.L. 111-5)5 included $2 billion to promote wide deployment of health information technologies. Two HHS advisory committees are to guide the development of information system standards and information technology policy. A health care perspec- tive appears to predominate in much of the work on health information technology, but the need to establish better information linkages between health care and the public health system has been recognized (AHIC, 2008; HITSP, 2008). These information system activities, although not driven by biosurveillance priorities, are clearly crucial in shaping the environment for improving information systems for biosurveillance. Within the National Academies, two committees are at work on related topics. The Committee to Review the Department of Homeland Security’s Approach to Risk Analysis is to issue a report at the end of 2009 or in early 2010. Its charge is to review how DHS is building capabilities in risk analysis to inform decision making. The study includes an evaluation of the 5 The American Recovery and Reinvestment Act of 2009 (P.L. 111-5) also includes provisions for approximately $17 billion in incentive payments to Medicare and Medicaid hospitals and providers to promote adoption of health information technology.

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3 INTROduCTION ANd BACKgROuNd quality of the current DHS approach to estimating risk for terrorist threats and for natural disasters and to applying those estimates in its management, planning, and resource-allocation activities. The Committee on Achieving Sustainable Global Capacity for Surveil- lance and Response to Emerging Diseases of Zoonotic Origin is expected to issue its final report in late 2009. The issues being examined include the causes of and trends in the emergence and spread over the past several decades of agents of zoonotic origin; the risks of animal and human inter- actions, especially for diseases of international significance such as H5N1 influenza; lessons from previous human and animal health responses to emergent zoonotic diseases; the current state of and gaps in global systems for surveillance of zoonotic infections in human and animal populations; and the appropriate balance between emergency response to threats and sustainable global surveillance capacity. THE COMMITTEE’S REPORT This report provides a review and assessment of the effectiveness and costs of surveillance for and detection of disease threats through the Bio- Watch program and through the U.S. public health and health care sys- tems. The committee presents its findings on the comparative merits of these approaches, examines costs, and describes promising enhancements to strengthen the nation’s capacity to conduct surveillance for major natural and man-made disease threats. As a result of its review, the committee identified various opportunities to further these enhancements, and it recommends ac- tions that DHS, HHS, and others should undertake to help realize them. REFERENCES AHIC (American Health Information Community Workgroup). 2008. Population health and clinical care connection: Transition report. September 23. http://www.hhs.gov/healthit/ ahic/materials/09_08/pop/transition_report.html (accessed March 6, 2009). Blair, D.C. 2009. Annual threat assessment of the Intelligence Community for the Senate Select Committee on Intelligence. Unclassified statement for the record, February. Washington, DC: Office of the Director of National Intelligence. http://intelligence.senate.gov/090212/ blair.pdf (accessed February 25, 2009). Buehler, J.W. 2008. Surveillance. In modern Epidemiology, 3rd ed. Edited by K.J. Rothman, S. Greenland, and T. L. Lash. Philadelphia, PA: Lippincott Williams & Wilkins. Pp. 459–480. CDC (Centers for Disease Control and Prevention). 2001a. Update: Investigation of bioterrorism-related anthrax and adverse events from antimicrobial prophylaxis. mor- bidity and mortality Weekly Report 50(44):973–976. CDC. 2001b. Updated guidelines for evaluating public health surveillance systems: Recom- mendations from the guidelines working group. morbidity and mortality Weekly Report 50(RR-13):1–35.

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