Following the attacks of September 11, 2001 and the anthrax letters, the ability to detect biological threats as quickly as possible became a top priority. In 2003 the Department of Homeland Security (DHS) introduced the BioWatch program-a federal monitoring system intended to speed detection of specific biological agents that could be released in aerosolized form during a biological attack. The present volume evaluates the costs and merits of both the current BioWatch program and the plans for a new generation of BioWatch devices. BioWatch and Public Health Surveillance also examines infectious disease surveillance through hospitals and public health agencies in the United States, and considers whether BioWatch and traditional infectious disease surveillance are redundant or complementary.

For many years, concerns about bioterrorism and emerging infectious diseases have drawn attention to the need for strong surveillance systems. Experts are working to develop new and better ways to detect these biological threats as quickly as possible. One effort in this area is the Department of Homeland Security's BioWatch program. To evaluate the effectiveness of the BioWatch program, the Institute of Medicine (IOM) and National Research Council (NRC) convened the Committee on Effectiveness of National Biosurveillance Systems: BioWatch and the Public Health System. This interim report contains no findings and recommendations, but outlines the committee's initial progress.

The Department of Homeland Security's (DHS's) BioWatch program aims to provide an early indication of an aerosolized biological weapon attack. The first generation of BioWatch air samplers were deployed in 2003. The current version of this technology, referred to as Generation 2 (Gen-2), uses daily manual collection and testing of air filters from each monitor, a process that can take 12 to 36 hours to detect the presence of biological pathogens. Until April 2014, DHS pursued a next-generation autonomous detection technology that aimed to shorten the time from sample collection to detection to less than 6 hours, reduce the cost of analysis, and increase the number of detectable biological pathogens. Because of concerns about the cost and effectiveness of the proposed Generation 3 system (Gen-3), DHS cancelled its acquisition plans for the next-generation surveillance system. In response to the cancellation announcement, Congress asked the Government Accountability Office (GAO) to conduct a review of the program and the proposed system enhancements that would have been incorporated in BioWatch Gen-3. However, Mike Walter, BioWatch Program manager, Office of Health Affairs, DHS, said that DHS did not agree with all of GAO's characterizations of the BioWatch program efforts described in this review. In response to this, DHS requested that the National Academies of Sciences, Engineering, and Medicine conduct a workshop to further explore the findings of the 2015 GAO report and discuss the impact these findings may have with regard to the future development of the technical capabilities of the BioWatch program. Workshop participants also discussed existing and possible collaborations between BioWatch, public health laboratories, and other stakeholders that could contribute to the enhancement of biosurveillance capabilities at the federal, state, and local levels. This publication summarizes the presentations and discussions from the workshop.

Early detection is essential to the control of emerging, reemerging, and novel infectious diseases, whether naturally occurring or intentionally introduced. Containing the spread of such diseases in a profoundly interconnected world requires active vigilance for signs of an outbreak, rapid recognition of its presence, and diagnosis of its microbial cause, in addition to strategies and resources for an appropriate and efficient response. Although these actions are often viewed in terms of human public health, they also challenge the plant and animal health communities. Surveillance, defined as "the continual scrutiny of all aspects of occurrence and spread of a disease that are pertinent to effective control", involves the "systematic collection, analysis, interpretation, and dissemination of health data." Disease detection and diagnosis is the act of discovering a novel, emerging, or reemerging disease or disease event and identifying its cause. Diagnosis is "the cornerstone of effective disease control and prevention efforts, including surveillance." Disease surveillance and detection relies heavily on the astute individual: the clinician, veterinarian, plant pathologist, farmer, livestock manager, or agricultural extension agent who notices something unusual, atypical, or suspicious and brings this discovery in a timely way to the attention of an appropriate representative of human public health, veterinary medicine, or agriculture. Most developed countries have the ability to detect and diagnose human, animal, and plant diseases. Global Infectious Disease Surveillance and Detection: Assessing the Challenges-Finding Solutions, Workshop Summary is part of a 10 book series and summarizes the recommendations and presentations of the workshop.

BioWatch is the Department of Homeland Security's (DHS's) system for detecting an aerosolized biological attack using collectors that are positioned strategically across the country to continuously monitor the air for biological threats. As currently deployed, BioWatch collectors draw air through filters that field technicians collect daily and transport to laboratories, where professional technicians analyze the material collected on the filter for evidence of biological threats. As part of the BioWatch program's efforts to enhance its effectiveness and capabilities, particularly with regard to detecting biological threats in challenging indoor environments, DHS requested the National Academies of Sciences, Engineering, and Medicine hold a workshop to explore alternative and effective biodetection systems for aerosolized biological agents that would meet BioWatch's technical and operational requirements, integrate into the existing system architecture and public health infrastructure, and be deployable by 2027. This publication summarizes the presentations and discussions from the workshop.

BioWatch is an air monitoring system deployed in jurisdictions around the country with the goal of detecting the presence of certain high risk pathogenic microorganisms. It relies on a network of federal and nonfederal collaborative relationships to be successful, and is one part of a larger array of disease surveillance, intelligence-gathering, and biomonitoring activities in support of public safety and health. The assays used in the BioWatch system to detect the presence of pathogens in collected samples rely on the technique of polymerase chain reaction (PCR) to sensitively and specifically amplify target nucleic acid sequences. BioWatch PCR Assays evaluates and provides guidance on appropriate standards for the validation and verification of PCR tests and assays in order to ensure that adequate performance data are available to public health and other key decision makers with a sufficient confidence level to facilitate the public health response to a BioWatch Actionable Response. This report discusses principles of performance standards, reviews information from several existing guidance documents and standards that might be applicable to BioWatch, and discusses assay testing efforts that have occurred or are ongoing. BioWatch PCR Assays provides recommendations on general principles and approaches for a performance standard and validation framework to meet BioWatch's mission. The report also considers how developments in technology, particularly in multiplex PCR and next-generation sequencing, can contribute to the ability of the BioWatch program to meet current and future challenges. This report has been determined to contain information exempt from disclosure under 5 U.S.C. 552(b). Section 15 of the Federal Advisory Committee Act provides that the National Academies shall make its final report available to the public unless the National Academies determines that the report would disclose matters described in one or more of the exemption provisions under the Freedom of Information Act (FOIA). In such case, the National Academies "shall make public an abbreviated version of the report that does not disclose those matters." This unrestricted, abbreviated version of the report represents, in so far as possible, the committee's findings, recommendations, and other substantive material without disclosing materials described in 5 U.S.C. 552(b).