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BioWatch PCR Assays

Author: National Research Council

Publisher: National Academies Press

Published: 2015-06-26

Total Pages: 184

ISBN-13: 0309367255

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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).

Book Synopsis BioWatch PCR Assays by : National Research Council

Download or read book BioWatch PCR Assays written by National Research Council and published by National Academies Press. This book was released on 2015-06-26 with total page 184 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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).

BioWatch and Public Health Surveillance

Author: National Research Council

Publisher: National Academies Press

Published: 2011-01-25

Total Pages: 252

ISBN-13: 030918763X

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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.

Book Synopsis BioWatch and Public Health Surveillance by : National Research Council

Download or read book BioWatch and Public Health Surveillance written by National Research Council and published by National Academies Press. This book was released on 2011-01-25 with total page 252 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Enhancing BioWatch Capabilities Through Technology and Collaboration

Author: National Academies of Sciences, Engineering, and Medicine

Publisher: National Academies Press

Published: 2017-12-29

Total Pages: 111

ISBN-13: 030945171X

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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.

Book Synopsis Enhancing BioWatch Capabilities Through Technology and Collaboration by : National Academies of Sciences, Engineering, and Medicine

Download or read book Enhancing BioWatch Capabilities Through Technology and Collaboration written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2017-12-29 with total page 111 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Strategies for Effective Improvements to the BioWatch System

Author: National Academies of Sciences, Engineering, and Medicine

Publisher: National Academies Press

Published: 2018-05-17

Total Pages: 223

ISBN-13: 0309471745

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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.

Book Synopsis Strategies for Effective Improvements to the BioWatch System by : National Academies of Sciences, Engineering, and Medicine

Download or read book Strategies for Effective Improvements to the BioWatch System written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2018-05-17 with total page 223 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Technologies to Enable Autonomous Detection for BioWatch

Author: National Research Council

Publisher: National Academies Press

Published: 2013-12-31

Total Pages: 244

ISBN-13: 0309292549

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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 maintains the sampling component, the sensors that collect airborne particles. The Centers for Disease Control and Prevention 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 Investigation is designated as the lead agency for the law enforcement response if a bioterrorism event is detected. In 2003 DHS deployed the first generation of BioWatch air samplers. The current version of this technology, referred to as Generation 2.0, requires daily manual collection and testing of air filters from each monitor. 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. Technologies to Enable Autonomous Detection for BioWatch is the summary of a workshop hosted jointly by the Institute of Medicine and the National Research Council in June 2013 to explore alternative cost-effective systems that would meet the requirements for a BioWatch Generation 3.0 autonomous detection system, or autonomous detector, for aerosolized agents . The workshop discussions and presentations focused on examination of 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 over three different tiers of temporal timeframes: those 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 are not likely to be ready until after 2020. Technologies to Enable Autonomous Detection for BioWatch discusses the history of the BioWatch program, the role of public health officials and laboratorians in the interpretation of BioWatch data and the information that is needed from a system for effective decision making, and the current state of the art of four families of technology for the BioWatch program. This report explores how the technologies discussed might be strategically combined or deployed to optimize their contributions to an effective environmental detection capability.

Book Synopsis Technologies to Enable Autonomous Detection for BioWatch by : National Research Council

Download or read book Technologies to Enable Autonomous Detection for BioWatch written by National Research Council and published by National Academies Press. This book was released on 2013-12-31 with total page 244 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 maintains the sampling component, the sensors that collect airborne particles. The Centers for Disease Control and Prevention 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 Investigation is designated as the lead agency for the law enforcement response if a bioterrorism event is detected. In 2003 DHS deployed the first generation of BioWatch air samplers. The current version of this technology, referred to as Generation 2.0, requires daily manual collection and testing of air filters from each monitor. 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. Technologies to Enable Autonomous Detection for BioWatch is the summary of a workshop hosted jointly by the Institute of Medicine and the National Research Council in June 2013 to explore alternative cost-effective systems that would meet the requirements for a BioWatch Generation 3.0 autonomous detection system, or autonomous detector, for aerosolized agents . The workshop discussions and presentations focused on examination of 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 over three different tiers of temporal timeframes: those 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 are not likely to be ready until after 2020. Technologies to Enable Autonomous Detection for BioWatch discusses the history of the BioWatch program, the role of public health officials and laboratorians in the interpretation of BioWatch data and the information that is needed from a system for effective decision making, and the current state of the art of four families of technology for the BioWatch program. This report explores how the technologies discussed might be strategically combined or deployed to optimize their contributions to an effective environmental detection capability.

Global Infectious Disease Surveillance and Detection

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2007-11-11

Total Pages: 284

ISBN-13: 0309111145

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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.

Book Synopsis Global Infectious Disease Surveillance and Detection by : Institute of Medicine

Download or read book Global Infectious Disease Surveillance and Detection written by Institute of Medicine and published by National Academies Press. This book was released on 2007-11-11 with total page 284 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Biodefense in the Age of Synthetic Biology

Author: National Academies of Sciences, Engineering, and Medicine

Publisher: National Academies Press

Published: 2019-01-05

Total Pages: 189

ISBN-13: 0309465184

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Scientific advances over the past several decades have accelerated the ability to engineer existing organisms and to potentially create novel ones not found in nature. Synthetic biology, which collectively refers to concepts, approaches, and tools that enable the modification or creation of biological organisms, is being pursued overwhelmingly for beneficial purposes ranging from reducing the burden of disease to improving agricultural yields to remediating pollution. Although the contributions synthetic biology can make in these and other areas hold great promise, it is also possible to imagine malicious uses that could threaten U.S. citizens and military personnel. Making informed decisions about how to address such concerns requires a realistic assessment of the capabilities that could be misused. Biodefense in the Age of Synthetic Biology explores and envisions potential misuses of synthetic biology. This report develops a framework to guide an assessment of the security concerns related to advances in synthetic biology, assesses the levels of concern warranted for such advances, and identifies options that could help mitigate those concerns.

Book Synopsis Biodefense in the Age of Synthetic Biology by : National Academies of Sciences, Engineering, and Medicine

Download or read book Biodefense in the Age of Synthetic Biology written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2019-01-05 with total page 189 pages. Available in PDF, EPUB and Kindle. Book excerpt: Scientific advances over the past several decades have accelerated the ability to engineer existing organisms and to potentially create novel ones not found in nature. Synthetic biology, which collectively refers to concepts, approaches, and tools that enable the modification or creation of biological organisms, is being pursued overwhelmingly for beneficial purposes ranging from reducing the burden of disease to improving agricultural yields to remediating pollution. Although the contributions synthetic biology can make in these and other areas hold great promise, it is also possible to imagine malicious uses that could threaten U.S. citizens and military personnel. Making informed decisions about how to address such concerns requires a realistic assessment of the capabilities that could be misused. Biodefense in the Age of Synthetic Biology explores and envisions potential misuses of synthetic biology. This report develops a framework to guide an assessment of the security concerns related to advances in synthetic biology, assesses the levels of concern warranted for such advances, and identifies options that could help mitigate those concerns.

Strategies for Effective Improvements to the BioWatch System

Author: National Academies of Sciences, Engineering, and Medicine

Publisher: National Academies Press

Published: 2018-04-17

Total Pages: 223

ISBN-13: 030947177X

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Book Synopsis Strategies for Effective Improvements to the BioWatch System by : National Academies of Sciences, Engineering, and Medicine

Download or read book Strategies for Effective Improvements to the BioWatch System written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2018-04-17 with total page 223 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Continuing Concerns Over BioWatch and the Surveillance of Bioterrorism

Author: United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Oversight and Investigations

Publisher:

Published: 2014

Total Pages: 340

ISBN-13:

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Book Synopsis Continuing Concerns Over BioWatch and the Surveillance of Bioterrorism by : United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Oversight and Investigations

Download or read book Continuing Concerns Over BioWatch and the Surveillance of Bioterrorism written by United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Oversight and Investigations and published by . This book was released on 2014 with total page 340 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Department of Homeland Security Bioterrorism Risk Assessment

Author: National Research Council

Publisher: National Academies Press

Published: 2009-01-03

Total Pages: 172

ISBN-13: 0309120284

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The mission of Department of Homeland Security Bioterrorism Risk Assessment: A Call for Change, the book published in December 2008, is to independently and scientifically review the methodology that led to the 2006 Department of Homeland Security report, Bioterrorism Risk Assessment (BTRA) and provide a foundation for future updates. This book identifies a number of fundamental concerns with the BTRA of 2006, ranging from mathematical and statistical mistakes that have corrupted results, to unnecessarily complicated probability models and models with fidelity far exceeding existing data, to more basic questions about how terrorist behavior should be modeled. Rather than merely criticizing what was done in the BTRA of 2006, this new NRC book consults outside experts and collects a number of proposed alternatives that could improve DHS's ability to assess potential terrorist behavior as a key element of risk-informed decision making, and it explains these alternatives in the specific context of the BTRA and the bioterrorism threat.

Book Synopsis Department of Homeland Security Bioterrorism Risk Assessment by : National Research Council

Download or read book Department of Homeland Security Bioterrorism Risk Assessment written by National Research Council and published by National Academies Press. This book was released on 2009-01-03 with total page 172 pages. Available in PDF, EPUB and Kindle. Book excerpt: The mission of Department of Homeland Security Bioterrorism Risk Assessment: A Call for Change, the book published in December 2008, is to independently and scientifically review the methodology that led to the 2006 Department of Homeland Security report, Bioterrorism Risk Assessment (BTRA) and provide a foundation for future updates. This book identifies a number of fundamental concerns with the BTRA of 2006, ranging from mathematical and statistical mistakes that have corrupted results, to unnecessarily complicated probability models and models with fidelity far exceeding existing data, to more basic questions about how terrorist behavior should be modeled. Rather than merely criticizing what was done in the BTRA of 2006, this new NRC book consults outside experts and collects a number of proposed alternatives that could improve DHS's ability to assess potential terrorist behavior as a key element of risk-informed decision making, and it explains these alternatives in the specific context of the BTRA and the bioterrorism threat.