BIOSECURITY AND BIOTERRORISM Containing and Preventing Biological Threats Second Edition JEFFREY R RYAN Department of Emergency Management Jacksonville State University Jacksonville, Alabama, USA Amsterdam • Boston • Heidelberg • London New York • Oxford • Paris • San Diego San Francisco • Singapore • Sydney • Tokyo Butterworth-Heinemann is an imprint of Elsevier Butterworth-Heinemann is an imprint of Elsevier The Boulevard, Langford Lane, Kidlington, Oxford OX5 1GB, UK 50 Hampshire Street, 5th Floor, Cambridge, MA 02139, USA Copyright © 2016, 2008 Elsevier Inc All rights reserved No part of this publication may be reproduced or transmitted in any form or by any means, ­electronic or mechanical, including photocopying, recording, or any information storage and retrieval system, without permission in writing from the publisher Details on how to seek permission, further ­information about the Publisher’s permissions policies and our arrangements with organizations such as the Copyright 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property as a matter of products liability, negligence or otherwise, or from any use or operation of any methods, products, instructions, or ideas contained in the material herein British Library Cataloguing-in-Publication Data A catalogue record for this book is available from the British Library Library of Congress Cataloging-in-Publication Data A catalog record for this book is available from the Library of Congress ISBN: 978-0-12-802029-6 For information on all Butterworth-Heinemann publications visit our website at https://www.elsevier.com/ Credits for front cover images National Institute of Allergy and Infectious Diseases (NIAID) CDC/Photographer, Christina Nelson, MD, MPH National Institute of Allergy and Infectious Diseases (NIAID) CDC/Photographer, James Hicks CDC/Photographer, Nahid Bhadelia, MD National Institute of Allergy and Infectious Diseases (NIAID) ABOUT THE AUTHOR Dr Jeff Ryan is a retired US Army Lieutenant Colonel with an extensive background in preventive medicine, epidemiology, clinical trials, and diagnostics development Dr Ryan also served in the private sector, working for a biotech company, Cepheid, where he was a senior business developer and manager for its biothreat government business program Dr Ryan has written more than 40 scientific, peer-reviewed journal articles and is coauthor of two other textbooks Dr Ryan currently serves as an associate professor and is Head of the Department of Emergency Management at Jacksonville State University His specialty areas include biosecurity, biodefense, medical aspects of emergency management, homeland security planning and preparedness, and terrorism studies xi PREFACE This book is the result of much research, writing, and thoughtful discussion with students, first responders, scholars, and thought leaders in the fields of biosecurity and biodefense It comes at a time when emergency managers, public health professionals, clinicians, animal health professionals, and government officials are preparing themselves for acts of terrorism and the potential that weapons of mass destruction may be used against our citizens At the dawning of the 21st century we moved very quickly from the information age to the Age of Terrorism Historians certainly will recall how the dark specter of terrorism raised its ugly head in the fall of 2001 as we witnessed the fall of the Twin Towers at the World Trade Center in New York and a direct attack on the Pentagon in Washington, DC Less than a month later citizens of the United States were faced with the threat of a deadly and rare disease, anthrax, which was spread by a few letters introduced into the US Postal System Looking back, this period now seems almost surreal to us Although these human-made disasters affected all of us in different ways, many Americans have already forgotten their personal feelings at the time The global war on terrorism has been raging for several years now Some would argue that taking the battle to the enemy on another front in a distant land has given us some modicum of protection ­Nonetheless, we are as vulnerable to the biological threat today as we were 15 years ago In the wake of the terrorist attacks and anthrax assaults of fall 2001, US policymakers developed the nucleus of a new regulatory framework to address the suddenly evident threat of bioterrorism (Dr Julie E Fischer, February 2006) Accordingly, Biosecurity and Bioterrorism: Containing and Preventing Biological Threats introduces readers to global concerns for biosecurity, including the history of biological warfare, bioterrorism, concerns for agroterrorism, and current initiatives in biodefense Included is a thorough review of specific agents, the diseases they cause, detection methods, and consequence management considerations Readers are introduced to ­ international initiatives and federal legislation that address biosecurity and biodefense A comprehensive treatment of the subject is needed to promote understanding of the problem and the complex network of federal, state, and local assets for dealing with the threat The book is intended to be used as a textbook or reference for security managers in the food industry, public health professionals, and emergency managers The primary goal of Biosecurity and Bioterrorism: Containing and Preventing Biological Threats is to give readers an understanding of the threat that biological agents pose to society Accordingly, the book details the myriad threats posed to society by the ­Department of Health and Human Services (HHS) Category A, B, and C agents Readers are presented xiii xiv Preface with several case studies that illustrate the effect of certain biological agents on society Readers will be able to discuss federal programs and initiatives that encompass the government’s vision of Biodefense for the Twenty-First Century TERMINAL LEARNING OBJECTIVES After reading this textbook, students will be able to: • Discuss the history of bioweapons development and how those programs relate to the current threat of bioterrorism • Discuss what biological agents are and how they can cause illness and death • Understand that the scale of bioterrorist and natural events makes a tremendous difference in our ability to respond to them • Understand what criteria are important in placing the most serious pathogens and toxins into HHS Categories A, B, and C • Know the different biological agents in HHS Categories A, B, and C; what diseases they cause; and the signs and symptoms of the associated disease In addition, students will understand the natural history of each of these agents, their use in warfare and bioterrorism, and public health issues • Discuss specific case studies that examine bioterrorism and natural disease outbreaks • Demonstrate familiarity with sampling and detection methods • List the laws and presidential directives that apply to biodefense and biosecurity • Discuss many federal initiatives and programs designed to enhance biodefense and biosecurity in the United States • Understand the difference between quarantine and isolation and the challenges both present • Understand programs that are implemented by public health agencies to enhance preparedness for acts of bioterrorism and where this fits into emergency preparedness programs THE PEDAGOGICAL FEATURES OF THIS BOOK • Objectives and Key Terms at the beginning of all chapters guide the reader on chapter content and the topics to understand • Examples, illustrations, and figures help explain concepts and relate theory to practice • Boxed topics are contained in each chapter to extend the depth of the information and to offer additional perspective on the issues • Critical Thinking boxes throughout the book help the reader to formulate alternative perspectives on issues and seek creative and improved solutions to problems Preface • Discussion Questions at the end of each chapter reinforce content and provide an opportunity for the reader to review, synthesize, and debate major concepts and issues • Websites at the end of each chapter provide direction for additional resources to enhance learning along topic lines and supplemental resources for student learning • An interdisciplinary research base was developed from books, journals, newsletters, magazines, associations, government, training programs, and other professional sources The book is organized into four thematic sections Part I provides a conceptual understanding of biowarfare, bioterrorism, and the reasons why biosecurity and biodefense are so important to modern day society Part II investigates HHS Category A, B, and C agents; case studies; and recognition of the threat Part III focuses on agricultural terrorism and food security Finally, Part IV outlines and details federal and local initiatives for biodefense and biosecurity; included here are considerations for government officials, emergency management practitioners, public health professionals, and first responders Each thematic section includes a short preface that draws together the key points and learning objectives of the chapters within them xv ACKNOWLEDGMENTS I thank my colleagues for taking the time to listen to my ideas and for pardoning me for my extended absences, idiosyncrasies, and preoccupation as I worked on researching and writing this book I also give special thanks to my lovely wife, Dr Pam Ryan, for critically reviewing each chapter while balancing the demands of a busy companion animal practice with the needs of two young daughters Finally, I thank the men and women in uniform, both military and civilian They are the guardians standing on the frontlines everywhere, protecting each other’s families Our hope is that they will find this compilation useful as they face the threat of asymmetric warfare xvii PART I Biosecurity, Biodefense, and the Reason for Them The first part of this book introduces the reader to the many foundational elements necessary to understand why biosecurity and biodefense have become so important to modern civilizations Both of those terms are described and differentiated To get an appreciation for biosecurity and biodefense, one must first understand the importance of the biological threat as an element of terrorism In addition, biological hazards can present themselves as the cause of accidental and natural disasters, such as laboratory mishaps and pandemics, respectively Biosecurity and biodefense concepts and programs are transparent to most people The reality is that biosecurity and biodefense programs are very costly and have been slow to develop Conversely, the threat of biological weapons and hazards is underlined by the unlimited potential for harm that they possess The use of biological weapons by an aggressor could kill millions, disrupt societies, undermine economies, and alter life as we know it Although the effects of a bioweapons attack could be dramatic and devastating, the probability that such an attack would happen is, in the opinion of some experts, very low Other experts believe with equal conviction that the risk is real and complacency will produce terrible consequences when the impossible happens Much of our concern about bioweapons comes from a belief that some terrorist groups, such as al Qaeda and ISIS, wish to use bioweapons and are attempting to develop Biosecurity and Bioterrorism a capability.Why terrorists would want to develop bioweapons is a complicated question that defies simple answers The decision to develop bioweapons likely involves perceptions that such weapons offer some political or military utility Some would argue that technological barriers to the development and use of bioweapons are sufficiently low for terrorists to use them Regardless, a key aspect of the perceived risk from bioweapons is that communities are extremely vulnerable to biological attacks There is a dearth of recent articles in the scientific literature and popular media discussing how unprepared modern societies are for biological terrorism.The abundance of these works might seem to reinforce the utility of bioweapons in the eyes of terrorists, thus exacerbating the problem Regardless, perceived terrorist motivations, increasing technological feasibility, and stated societal vulnerability have now merged to catalyze fears about bioweapon proliferation and use Chapter, Seeds of Destruction is an introduction to the history of biowarfare and state-sponsored bioweapons programs In addition, the reality versus the potential of bioterrorism is discussed and the reasons why biosecurity and biodefense have become so formidable in the United States and other Western nations Chapter, Recognition of Biological Threat provides a scientific foundation for all readers, no matter their professional discipline or background As such, the different types of biological agents and some of their common characteristics are detailed From here the reader is introduced to terminology related to the clinical presentation of infectious disease and diagnostic processes.The information and understanding gained from these two chapters is essential to fully understanding the threat that will be explored in subsequent sections CHAPTER Seeds of Destruction Destroy the seed of evil, or it will grow up to your ruin Aesop Objectives The study of this chapter will enable you to: Understand the importance of the biological threat in its context of terrorism and weapons of mass destruction Discuss the terms biosecurity and biodefense and relate them to homeland security and defense, respectively Discuss the reality versus the potential of bioterrorism Discuss the history of biowarfare and the major events that are important in helping us understand the issues related to using biological substances against an adversary Understand why many of these threats have been used on a small scale and that going beyond that requires a high degree of technical sophistication and extensive resources Discuss international and national sentiments toward biothreat scenarios and programs INTRODUCTION The dawning of the 21st century will be characterized as the Age of Terrorism.Terrorism has affected most of us in one way or another The shocking images of the September 11, 2001, attacks remind us of just how dramatic and devastating terrorism can be In most developed countries, the concept of bioterrorism and many of the words associated with it are widely recognized In the United States, bioterrorism became a household word in October 2001, when Bacillus anthracis (the causative agent of anthrax) spores were introduced into the US Postal Service system by several letters dropped into a mailbox in Trenton, New Jersey (see Fig 1.1) These letters resulted in deaths from pulmonary anthrax and 17 other cases of inhalation and cutaneous anthrax (Thompson, 2003) In the weeks and months that followed, first responders were called to the scene of thousands of “white powder” incidents that came as a result of numerous hoaxes, mysterious powdery substances, and just plain paranoia (Beecher, 2006) Public health laboratories all over the United States were inundated with samples collected from the scene of these incidents Testing of postal facilities, US Senate office buildings, and Biosecurity and Bioterrorism ISBN 978-0-12-802029-6 http://dx.doi.org/10.1016/B978-0-12-802029-6.00001-3 Copyright © 2016 Elsevier Inc All rights reserved 356 Biosecurity and Bioterrorism These designations expand on the traditional classifications of Category A, B, and C agents because they address the fact that future threats are likely to be unanticipated and ill defined Although appropriate and effective for the highest priority traditional threats, such as smallpox and anthrax, developing medical countermeasures using a conventional “one bug–one drug” approach will rapidly prove unsustainable as the list of threats increases to include enhanced, emerging, and advanced agents Responding to traditional and new types of threats requires the capability to rapidly identify unknown or poorly defined agents, quickly evaluate the efficacy of available interventions, and develop and deploy novel treatments to prevent or mitigate medical consequences and the subsequent impact on society It is certain that the importance of the Laboratory Response Network and the establishment of regional centers of excellence for biodefense and emerging infectious diseases have been realized (see Fig 14.3) Maintaining this vital capability to guide recognition of the threat is costly but essential THE FUTURE OF BIODEFENSE RESEARCH Scientific research for biodefense is constantly needed to identify new diagnoses, prevention, or treatment for infectious disease Commensurate with this, the infectious diseases community might elect to encourage and reward basic science research efforts that seek to produce novel diagnostic technologies and preventive or therapeutic interventions for the diseases caused by biological weapons.That agenda was successfully outlined in 2005 by Dr Anthony Fauci, Director of the National Institutes of Health (Fauci, 2005) Developing medical countermeasures against a finite number of known or anticipated agents is a sound approach for mitigating the most catastrophic biological threats However, responding to enhanced, emerging, and advanced agents demands new paradigms, which allow for more rapid and cost-effective development of countermeasures The National Institutes of Health, in collaboration with other agencies, established a solid framework of research and product development resources for biodefense The program, outlined in 2007, called for new approaches to provide the flexibility required to meet the challenges of nontraditional threats The National Institute for Allergy and Infectious Diseases (2007) identified three “broad-spectrum” strategies to create a more responsive biodefense capability (see Fig 14.4) These strategies remain in place and are hereafter described Broad-Spectrum Activity Broad-spectrum activity is a characteristic that enables a particular product to mitigate biological threats across a wide range or class of agents Multiplex diagnostics possessing broad-spectrum activity rapidly differentiate various common and lesser-known pathogens in a single clinical sample, identify drug sensitivities, and determine how a Future Directions for Biosecurity Figure 14.3  A scientist in the process of transferring specimens in one of the Centers for Disease Control biosafety level-4 laboratories, located in Atlanta, Georgia The scientist wears a protective airtight suit equipped with a helmet and face mask She is seated at a negatively pressurized laminar flow hood that allows no air flow to escape back into the laboratory environment Using this negatively pressurized, hooded environment, any airborne pathogens or toxic vapors are drawn back into the hooded container and up into a filtered ventilation system, thereby avoiding the spread of contaminants through the laboratory Although these facilities are very costly to staff and maintain, they are vital and give us the ability to investigate unknown threats and emerging diseases Regional centers of excellence have given the United States biosafety level-4 capacity Courtesy of the Centers for Disease Control Public Health Image Library sample pathogen is related to known pathogens Consider the lab-on-a-chip concept, in which a clinical specimen is placed on a microchip-like device, which has a complex microarray of DNA- or ribonucleic acid (RNA)–based diagnostics The chip allows the processing unit to test for dozens of possibilities simultaneously based on DNA- or RNA-hybridization modalities Some exciting new developments along these lines have already occurred Vaccines demonstrating broad-spectrum activity include cross-protective and multiple-component vaccines Cross-protective vaccines induce an immune response against constant components of a microbe; therefore they are effective against pathogens that naturally or deliberately evolve or “drift” 357 358 Biosecurity and Bioterrorism Figure 14.4 Priorities for biodefense research as established by the National Institutes of Health Director, Dr Anthony S Fauci These priorities have led to many accomplishments in the public health emergency countermeasures enterprise Courtesy of the National Institutes of Health A universal influenza vaccine is an example of a cross-protective vaccine Multiplecomponent vaccines include, within a single vaccine, elements that protect against viruses or microbes that are different but usually closely related An example of a multiple-component vaccine is a hemorrhagic fever vaccine that contains elements of Ebola, Marburg, and Lassa viruses For several traditional threats, safe and effective treatments are nonexistent, of limited usefulness, or susceptible to emerging antimicrobial resistance and genetically engineered threats A limited number of antiinfectives with broad-spectrum activity directed at common, invariable, and essential components of different classes of microbes could be effective against traditional and nontraditional threats This approach would allow a small number of drugs to replace dozens of pathogen-specific drugs In addition, the strategies to overcome antibacterial resistance could extend the clinical utility of existing broad-spectrum anti-infectives and have immediate benefits.Treatments that target host immune responses have the potential to be effective against multiple diseases These immune modulators reduce morbidity and mortality by controlling responses that contribute to disease (eg, cytokine storms) or nonspecifically activating the host’s natural immune defenses to induce a faster, more potent protective response Broad-Spectrum Technology Broad-spectrum technology refers to capabilities, such as temperature stabilization or delivery method, that can be engineered into a wide array of existing and candidate products Developing countermeasures that will be useful in responding to future threats represents a major challenge given the capabilities that these products Future Directions for Biosecurity must possess They should be safe and effective against multiple pathogens in people of any age and health status To be appropriate for storing in the Strategic National Stockpile, the products should be suitable for long-term storage at room temperature, have simple compact packaging, be easily delivered in a mass casualty setting, confer protection with limited dosing, and have single-dose delivery devices that can be self-administered Added to these factors is the potential need to produce additional quantities with little notice, requiring manufacturers to take the costly step of keeping production facilities on standby A recent example of this is the relatively rapid creation and production of a vaccine for H5N1 bird flu, which is already approved by the Food and Drug Administration with 5 million doses placed in the Strategic National Stockpile Broad-Spectrum Platforms Broad-spectrum platforms are standardized methods that can be used to significantly reduce the time and cost required to bring medical countermeasures to market For example, a proven monoclonal antibody fermentation and purification method can be applied to rapidly develop any therapeutic monoclonal antibody, avoiding lengthy development work Other examples of platform technologies include screening systems, in vitro safety testing, expression modules, manufacturing technologies, and chemical synthesis designs The potential to rapidly apply such platform methods to developing new countermeasures will considerably shorten and streamline the process Bioweapons and Scientists The community of biologists in the United States has maintained a kind of hand-wringing silence on the ethics of creating bioweapons—a reluctance to talk about it with the public, even a disbelief that it’s happening Biological weapons are a disgrace to biology The time has come for top biologists to assert their leadership and speak out, to take responsibility on behalf of their profession for the existence of these weapons and the means of protecting the population against them, just as leading physicists did a generation ago when nuclear weapons came along Moral pressure costs nothing and can help; silence is unacceptable now Richard Preston (1998) CONCLUSION It is clear that security and defense against biological threats, whether natural or the result of deliberate human action, will continue to be a high priority for the foreseeable future Biological warfare and bioterrorism are multifaceted problems requiring multifaceted solutions (Block, 1999) We need our best critical thinkers and biological 359 360 Biosecurity and Bioterrorism researchers to solve this constantly evolving problem Fortunately, the same advances in genomic biotechnologies that can be used to create bioweapons can also be used to set up countermeasures against them.The probability of a terrorist use of a genetically engineered biological agent on a given city is very low, but the consequence of such an event would obviously be very high With maximum casualties the likely goals, metropolitan areas are most at risk for an attack However, the indiscriminate nature of biological warfare and bioterrorism puts all communities at risk This dilemma is the challenge of local communities, which are sensitive to the need for preparedness but have finite resources Community officials must have a plan and sufficient medical and public health resources accessible to sustain a response for up to 24 h Robust federal assistance would be made available promptly, but it would not be immediate At present, all military and civilian populations throughout the world are vulnerable to a bioweapons attack We remain grossly ill-prepared to respond to an epidemic caused by a novel genetically engineered biological agent President Nixon said it best when he stated, “Mankind already carries in its own hands too many of the seeds of its own destruction.” We know that he was forewarning us that further advances in biowarfare and the production of bioweapons could ultimately end in our own demise Acting responsibly, he put an end to our biological weapons arsenal and focused our assets on biodefense rather than biooffense We now have in place sophisticated and well-developed biosecurity and biodefense programs.These programs are essential to countering the asymmetric warfare threat, but they are costly and perishable Future directions in biosecurity and biodefense may very well be determined by the “next event.” However, it is this author’s opinion that the most likely events are those that naturally and accidentally threaten human and animal health through the emergence of novel pathogens and the reemergence of others in light of new environmental or societal factors ESSENTIAL TERMINOLOGY • Binary bioweapons A two-component system consisting of innocuous parts that are mixed immediately before use to form the pathogen This process occurs frequently in nature Many pathogenic bacteria contain multiple plasmids (small, circular, extrachromosomal DNA fragments) that code for virulence or other special functions.Virulent plasmids can be transferred among different kinds of bacteria and often across species barriers (Block, 1999) • Designer diseases The possibility that science one day might allow a researcher to propose the symptoms of a hypothetical disease and then design or create the pathogen to produce the desired disease complex Designer diseases may work by turning off the immune system; by inducing specific cells to multiply and divide rapidly (similar to cancer); or possibly by causing the opposite effect, such as initiating Future Directions for Biosecurity programmed cell death (apoptosis).This futuristic biotechnology would clearly indicate an order of magnitude of advancement in offensive biological warfare or terrorism capability (Block, 1999) • Designer genes The entire genomes of numerous organisms have been published in unclassified journals and on the Internet Now that the codes are known, it seems only a matter of time until microbiologists develop synthetic genes, synthetic viruses, or even complete new organisms Some of these could be specifically produced for biological warfare or terrorism purposes (Block, 1999) • Gene therapy Gene therapy will revolutionize the treatment of human genetic diseases The goal is to effect a permanent change in the genetic composition of a person by repairing or replacing a faulty gene The same technology could be subverted to insert pathogenic genes in a targeted host of population (Block, 1999) • Host-swapping diseases Viruses that “jump species” may occasionally cause significant disease Manageable infectious agents can be transformed naturally into organisms with markedly increased virulence (Block, 1999) • Stealth viruses.The concept of a stealth virus is a cryptic viral infection that covertly enters human cells (genomes) then remains dormant for an extended time However, a signal by an external stimulus could later trigger the virus to activate and cause disease In fact, this mechanism occurs fairly commonly in nature For example, many humans carry herpes virus, which can activate to cause oral or genital lesions Similarly, varicella virus sometimes reactivates in the form of herpes zoster (shingles) in some people who had chickenpox earlier in life However, the vast majority of viruses not cause disease (Block, 1999) • Synthetic biology Synthetic biology is an interdisciplinary branch of biology combining disciplines such as biotechnology, evolutionary biology, molecular biology, systems biology, biophysics, computer engineering, and genetic engineering DISCUSSION QUESTIONS • What is the most likely reason for biosecurity programs to increase in scope and complexity? • Is a major act of bioterrorism likely in the next 5 years? If not, what will that to existing research programs and surveillance systems such as BioWatch? • Imagine that bioweapons programs come back into prominence and there is a renewed interest in creating superbugs in sophisticated state-sponsored programs How could technology today give a military advantage to a country? • What would be the likely outcome if an adversary overtly used a biological weapon against its enemy? What sort of a response would the international community pursue? Might it provoke the use of a nuclear weapon? 361 362 Biosecurity and Bioterrorism WEBSITES Regional centers of excellence for biodefense and emerging infectious diseases (10 centers, located nationwide, provide resources and communication systems that can be rapidly mobilized and coordinated with regional and local systems in response to an urgent public health event) Available at: http://www.niaid.nih.gov/labsandresources/ resources/rce/Pages/default.aspx National biocontainment laboratories (NBLs) and regional biocontainment laboratories (RBLs; NBLs and 13 RBLs are available or under construction for research requiring high levels of containment and are prepared to assist national, state, and local public health efforts in the event of a bioterrorism or infectious disease emergency) Available at: http://www.niaid.nih.gov/labsandresources/resources/dmid/nbl_rbl/ Pages/default.aspx The Biodefense and Emerging Infections Research Resources Repository (offers reagents and information essential for studying emerging infectious diseases and biological threats) Available at: https://www.beiresources.org/ Health and Human Services Public Health Emergency Countermeasures Enterprise Implementation and Strategic Plan (2014) Available at: http://www.phe.gov/Preparedness/ mcm/phemce/Documents/2014-phemce-sip.pdf National Institutes of Health Biodefense Strategic Plan Available at: http://www niaid.nih.gov/topics/BiodefenseRelated/Biodefense/Pages/strategicplan.aspx REFERENCES Ainscough, M., 2002 Next generation bioweapons: genetic and BW In: Davis, J., Schneider, B (Eds.), The Gathering Biological Warfare Storm USAF Counterproliferation Center, Air War College, Air University, Maxwell Air Force Base, Montgomery, AL (Chapter 9) Alibek, K., May 20, 1998 Terrorist and Intelligence Operations: Potential Impact on the US Economy Statement before the Joint Economic Committee U.S Congress Available at: http://fas.org/irp/ congress/1998_hr/alibek.htm Block, S., 1999 Living nightmares: biological threats enabled by molecular biology In: Drell, S., Sofaer, A., Wilson, G (Eds.), The New Terror: Facing the Threat of Biological and Chemical Weapons Hoover Institution Press, Stanford, CA, p 60 Davis, J., 2002 A biological warfare wake-up call: prevalent myths and likely scenarios In: Davis, J., Schneider, B (Eds.), The Gathering Biological Warfare Storm USAF Counterproliferation Center Air War College, Air University, Maxwell Air Force Base, Mongomery, AL (Chapter 10) Fauci, A., July 28, 2005 Testimony before the Committee on Homeland Security, Subcommittee on the Prevention of Nuclear and Biological Attack United States House of Representatives by the Director of the National Institute of Allergy and Infectious Diseases National Institutes of Health, U.S Department of Health and Human Services Finkbeiner, A., 2006 The Jasons: The Secret History of Science’s Postwar Elite.Viking Books, New York Garrett, L., 1995 The Coming Plague: Newly Emerging Diseases in a World Out of Balance Farrar, Straus and Giroux, New York Inglesby, T., O’Toole, T., Henderson, D.A., 2000 Preventing the use of biological weapons: improving response should prevention fail Clinical Infectious Diseases 30, 926–929 Future Directions for Biosecurity Jefferson, C., Lentzos, F., Marris, C., 2014 Synthetic biology and biosecurity: challenging the “myths” Frontiers in Public Health 2, 115 Available at: http://www.ncbi.nlm.nih.gov/pmc/articles/ PMC4139924/ Landrain, T., Meyer, M., Perez, A., Sussan, R., 2013 Do-it-yourself biology: challenges and promises for an open science and technology movement Systems and Synthetic Biology 7, 115–126 Miller, J., Engelberg, S., Broad, W., 2002 Germs: Biological Weapons and America’s Secret War Simon and Schuster, New York Mordini, E., 2005 Biowarfare as a biopolitical icon Poiesis & Praxis: International Journal of Technology Assessment and Ethics of Science 3, 242–255 National Institute of Allergy and Infectious Diseases, 2007 Strategic Plan for Biodefense Research 2007 Update U.S Department of Health and Human Services, National Institutes of Health, Washington, DC NOVA, 2001 Soviet “Superbugs,” Interview between NOVA and Sergei Popov Available at: www.pbs.org/ wgbh/nova/bioterror/biow_popov.html Preston, R., April 21, 1998 Taming the Biological Beast Op-Ed New York Times Sprinzak, E., November–December 2001 The lone gunman Foreign Policy 72–73 Tucker, J., 2011 Could Terrorists Exploit Synthetic Biology? The New Atlantis.com U.S Congress, Office of Technology Assessment, 1993 Technologies Underlying Weapons of Mass Destruction OTA-BP-ISC-115 Government Printing Office, Washington, DC U.S Department of Health and Human Services, 2014 Public Health Emergency Countermeasures Enterprise Implementation and Strategic Plan http://www.phe.gov/Preparedness/mcm/phemce/ Documents/2014-phemce-sip.pdf Wilson Center, 2015 U.S Trends in Synthetic Biology Research Funding Available at: https://www wilsoncenter.org/sites/default/files/final_web_print_sept2015_0.pdf Zilinskas, R., 2000 Biological Warfare: Modern Offense and Defense Lynne Rienner Publishers, Boulder, CO 363 INDEX Note: ‘Page numbers followed by “f ” indicate figures, “t” indicate tables and “b” indicate boxes.’ A Active disease surveillance, 267 Administrative/legal aspects biohazardous material transportation, 258 biological agent/toxin, 246 biological weapons, made up of, 245 legislation, 248f Centers for Disease Control (CDC), 247, 248t Department of Health and Human Services (HHS), 247 Public Law 107–188, 249 select agents, 247, 248t presidential directives, 249–250 HSPD 4, 250 HSPD 9, 250 HSPD 10, 250–251 HSPD 18, 251–252 HSPD 21, 252 public health and law application, 252 319 Emergency, 254–257 Health Insurance Portability and Accountability Act of 1996 (HIPAA), 253 nationally notifiable infectious diseases (NNIDs), 253 terrorism, defined, 246 weapons of mass destruction (WMD), 246 ADS See Autonomous detection systems (ADS) Aerosolization, 122 Agricultural terrorism See Agroterrorism Agriculture gross domestic product (GDP), 186 protection, 187 Agroterrorism, 214 act of, 197 chronology of biological attacks, 1915-2000, 193, 194t–195t defined, 193 economic impact, 198b lower physical risk, 198b lower technical barriers, 198b plant pathogens, use of, 195–197, 197f similarity to natural outbreaks, 198b smaller chance, outrage and backlash, 198b Airborne botulinum toxin, 81b Airborne transmission mode, 189 American Postal Workers Union (APWU), 324 Amerithrax, United States, 2001, 172f, 264, 264b, 323–324 cefotaxime, 171 cerebrospinal fluid, 171–172 chest X-ray, case patient, 170, 171f outbreaks, 173 physical examination, 170 Animal and Plant Health Inspection Service (APHIS), 203 Animal disease outbreak See Foreign animal diseases (FADs) Anthrax, 51–52, 82 in animals, 55 diagnosis, 56–57 etiologic agent, 52–53 true zoonoses cutaneous anthrax, 53–54 gastrointestinal anthrax, 54–55 inhalation anthrax, 53–54 injectional anthrax, 55 Arboviruses, 102, 109 Area command, 270, 285 Arenaviruses, 71–72 ASTM E-2458, 144 At-risk premises (ARPs), 208 Australia Group, 291–292, 292f, 318 Autonomous detection systems (ADS), 342 Amerithrax, 329 biothreat agents (BTAs), 327–328 concept of operation (CONOPS), 329 immunoassay strip tests, 328 Avian influenza, 24–25 B Bacillus anthracis, 3–4, 51–52, 163, 323–324 Bacillus globigii, 330 365 366 Index Bacterial pathogens, 35f characteristics, 33–34 history of microscopy, 33–34, 35f spores, 34 Bang disease, 86–91 Binary bioweapons, 348, 360 Biodefense, 20–21, 26 Biohazard Detection System (BDS), 6, 325, 337–338, 342 Bacillus globigii, 330 biosensor, 335f GeneXpert cartridge, 332, 333f polymerase chain reaction (PCR), 332, 334f development verification testing, 336–337 essential actions, 339f field testing summary, 336–337 GeneXpert system, 330 PCR technology, 329–330 performance results, 331–332 required technical specifications, 331 Biological agents, 259 characteristics, 31 incubation period, 32 pathogenic, 32 routes of entry absorption, 33 anthrax spores, 33, 34f ingestion, 32 inhalation, 32 injection, 33 virulence, 32 Biological product, 259 Biological terrorism, acts, 56b Biological threat See also Biological agents bacterial pathogens, 35f characteristics, 33–34 history of microscopy, 33–34, 35f spores, 34 biological toxins, 38–39, 39f clinical manifestations, 40 disease, defined, 40 etiology, 40 fungal pathogens, 38 prions, 37–38 probability of use aggressor, 44 explosives, 42 mass casualty potential, 43, 43t World Health Organization (WHO), 43 rickettsial pathogens, 36 tiered diagnostic system (TDS), 40–42 viral pathogens, 36–37, 37f Biological toxins, 38–39, 39f, 45, 259 Biological Weapons Anti-Terrorism Act of 1989, 245 Biological Weapons Convention (BWC), 245 Biomedical Advanced Research and Development Authority (BARDA), 294 Biosafety, 214 Biosecurity, 26, 214 case designations confirmed positive case, 202 presumptive positive case, 202 suspect case, 201 common hazards, 199 future development advanced agents, 355 binary bioweapons, 348 broad-spectrum activity, 356–358 broad-spectrum platforms, 359 broad-spectrum technology, 359 dark specter of terrorism, 352–354 designer diseases, 348 designer genes, 348 emerging agents, 355 enhanced agents, 355, 355f gene therapy, 348 H5N1, 345–347 host-swapping diseases, 348 nH1N1, 345–347, 346f secret group of academic scientists, 347–348 Soviet Superbug program, 348–350 stealth viruses, 348 synthetic biology, 350–351 traditional agents, 355 isolation, 199–200, 200f mitigating risk, 201 sanitation, 201 traffic control, 201 Biosecurity programs/assets Amerithrax incident, 2001, 290b BioSense, 305–308 Cities Readiness Initiative, 308–309 hazard mitigation Australia Group, 291–292 NSABB, 297–299 Project BioShield, 291–297 Index indications and characteristics, bioterrorism, 289–290, 290t preparedness, 299–300 BioWatch program, 302–305 mass prophylaxis caches, 300–302, 301f prophylaxis, 300 response and recovery, 309 Bio-LRN, 310 considerations for responders, 313–314 federal, 310 hazardous materials response unit, 314–315 national laboratories, 311–313 reference laboratories, 311 sentinel laboratories, 310–311 state and local public health, 310 WMD CST, 315–317 weapons of mass destruction (WMDs), 290 BioSense program, 305–308, 318 BioShield program, 5–6, 318 Bioterrorism, 26 Biohazard Detection System (BDS), BioShield, 5–6 civilian biodefense funding, 5–6, 6t defined, FY2001 vs FY2005, 5–6 human immunodeficiency virus (HIV), 6–7 BioThrax, 294–295 Biowarfare, 4–5, 26 Bacillus globigii, 12 Biological Weapons Convention, 13 Camp Detrick, 10 German military, malaria, miasmas, seminal moments, 13, 14t–15t Stalingrad, 10 Unit 731, 9–10 BioWatch program, 302f, 318 Nuclear Threat Initiative, 303 specific organisms, 302–303 US Department of Agriculture (USDA), 303 Black Death, 58b Botulinum toxin, 78, 78b Botulism, 82 Clostridium botulinum, 78 electromyography, 80–81 foodborne botulism, 79, 80f sausage, 78–79 treatment, 81 wound botulism, 80 Bovine spongiform encephalopathy (BSE), 231–234, 236 food chain protection, 234–235 implications, human health, 226–227 incubation period, cattle, 225–226 Brucella, 86, 87t Brucellosis, 109 in biowarfare, 91b Brucella, 86, 87t clinical presentation, 89–90 diagnosis, 90–91 history, 87 incidence, 88–89, 89f transmission, 88 treatment, 90–91 Bubonic plague, 60 Buffer-surveillance zone (BSZ), 206–207 Bunyaviruses, 71–73 Burkholderia, 91 C Camp Detrick, 10, 11f Category A agents, 51, 52t Category B diseases/agents brucellosis Brucella, 86, 87t clinical presentation, 89–90 diagnosis, 90–91 history, 87 incidence, 88–89, 89f transmission, 88 treatment, 90–91 etiologic agents, 85, 86t glanders Burkholderia mallei, 92 clinical presentation, 93–94 diagnosis, 94–95 history, 92–93 transmission, 93 treatment, 94–95 melioidosis, 92 psittacosis in birds, 101–102 Chlamydophila psittaci, 99 clinical presentation, 101 diagnosis, 101 history, 99–100 incidence, 100, 100f 367 368 Index Category B diseases/agents (Continued) transmission, 101 treatment, 101 Q fever clinical presentation, 97–98 Coxiella burnetii, 95 diagnosis, 98–99 history, 95–96 incidence, 96–97 transmission, 96 treatment, 98–99 ricin poisoning, 106–108 viral encephalitis, 102–106 Category C diseases/agents bird flu, 114 hantavirus clinical presentation, 122–123 diagnosis, 123 disinfectants, 118 Four Corners outbreak, 120–122 history, 119–120 rodents, 119, 120f transmission, 122 treatment, 123 H5N1, 114 Middle East respiratory syndrome clinical presentation, 131 colorized transmission electron micrograph, 129, 130f diagnosis and treatment, 131 transmission, 130–131 Nipah virus, 115 clinical presentation, 117–118 diagnosis and treatment, 117–118 Malaysian Ministry of Health (MOH), 116–117 transmission, 117 transmission electron micrographic image, 115, 116f pathogens, 114–115, 115t severe acute respiratory syndrome virus, 127–129, 127f West Nile virus clinical presentation, 126–127 diagnosis and treatment, 126–127 isolation, 123 transmission, 125–126 United States, 1999 and 2014, 124, 125t Cefotaxime, 171 Centers for Disease Control (CDC), 42, 56, 58, 114, 165, 247, 248t Chlamydophila psittaci, 99 Chronic glanders, 94 Ciprofloxacin, 56b Cities Readiness Initiative (CRI), 308–309 Classical swine fever (CSF), 223–225, 224f, 231, 236 Clostridium botulinum, 78 Cluster, 180 Community quarantine, 283–284 Compound 19, 163 Concept of operations (CONOPS), 329, 342 Consequence management, 343 crisis management, 327 defined, 326 National Response Plan (NRP), 327 weapons of mass destruction (WMDs), 326 Contact premise (CP), 208 Contact tracing, 281–282, 286 Cordon sanitaire, 168, 180 Coxiella burnetii, 95 Critical infrastructure, 214 Cryptosporidiosis, 20 Cutaneous anthrax, 53–54, 54f, 162, 323–324 Cutaneous form of glanders, 94 D Deer fly fever, 62–66 Department of Health and Human Services (HHS), 142–143, 247 Department of Homeland Security (DHS), 271–272, 292 Department of Justice, 273 Designer diseases, 348, 361 Designer genes, 348, 361 De-skilling, 351, 351b Diagnostic specimen, 259 Differential diagnosis, 46 Direct transmission mode, 189 Downer cow, 234, 236 E Ebola virus disease (EVD), 22–23, 23f, 175–176 in West Africa, 2014-15 disinfection procedures, 176, 177f emergency room (ER), 176–177 enzootic and epizootic cycle, 175–176, 176f hazardous materials professionals, 177–178, 178f Index Edgewood Arsenal, 196–197 319 Emergency declaration, 255 isolation, 255–256, 255b, 256f Public Health Service Act, 254 quarantine, 255–256, 256f, 257b Emergency operations centers (EOCs), 217 Emergency support function (ESF) 11, 204 Emerging disease, 132 Environmental Protection Agency (EPA), 274 EVD See Ebola virus disease (EVD) F FADs See Foreign animal diseases (FADs) Fallen Angel ricin incidents, 2003-04, 173–175, 174f Federal Emergency Management Agency (FEMA), 273–274 Filoviruses, 71, 74–75, 74f Flaviviruses, 75–76 FMD See Foot and mouth disease (FMD) Fomite, 180 Food safety, 212–213 Foot and mouth disease (FMD), 189, 220f, 220t, 236 costs, 222 picornavirus, 219 serotypes, types, 219 United Kingdom, 2001, 227–229 United States, 221 Foreign animal diseases (FADs) airborne transmission mode, 189 animal quarantine laws and statutes, 208–209 at-risk premises (ARPs), 208 biocontainment, 203 bovine spongiform encephalopathy (BSE) implications, human health, 226–227 incubation period, cattle, 225–226 buffer-surveillance zone (BSZ), 206–207 carcass disposal, 210–211 classical swine fever (CSF), 223–225 contact premise (CP), 208 control area (CA), 206 crop security, 191 depopulation and culling, 210 direct transmission mode, 189 disinfection, 211 emergency operations centers (EOCs), 217 emergency support function (ESF) 11, 204 enhanced biosecurity, 205 foot and mouth disease (FMD), 220f, 220t costs, 222 picornavirus, 219 serotypes, types, 219 United States, 221 free premises (FPs), 208 free zone (FZ), 207 highly pathogenic avian influenza (HPAI), 222–223 Incident Command System (ICS), 218 infected premise (IP), 208 infected zone (IZ), 206 involvement of local responders, 212 karnal bunt, 192 List A diseases, 187–188, 188t movement control, 210 movement restrictions, 205–206 National Incident Management System (NIMS), 218 Office International des Epizooties/Epizootics (OIE), 187–188 domestic compliance, 189–191 four inclusion criteria, 189, 190f plant pathogens, 191 plum pox virus (PPV), 192–193 rice blast, 192 soybean rust, 192 surveillance zones (SZs), 208 suspect premises (SPs), 208 vector transmission mode, 189 Francisella tularensis, 62 Free premises (FPs), 208 French anticrop program, 196 Fungal pathogens, 38 G Gastrointestinal anthrax, 54–55, 162 Gene therapy, 348, 361 GeneXpert system, 330 Germ warfare, 26 Glanders, 109 Burkholderia mallei, 92 clinical presentation, 93–94 diagnosis, 94–95 history, 92–93 transmission, 93 treatment, 94–95 Great Plague, 58b Group quarantine, 283 369 370 Index H K Hantavirus, 132 clinical presentation, 122–123 diagnosis, 123 disinfectants, 118 Four Corners outbreak, 120–122 history, 119–120 rodents, 119, 120f transmission, 122 treatment, 123 Hazardous Materials Response Unit (HMRU), 319 Health Insurance Portability and Accountability Act of 1996 (HIPAA), 253 Hemorrhagic smallpox, 69 Highly pathogenic avian influenza (HPAI), 222–223 H5N1, 229 H5N2, 229 H7N1, 229 H7N2, 230 H7N7, 231 LPAI H7N2, 230 outbreaks, 232t H5N1, 24–25, 114 H5N2, 25 H5N8, 25 Homeland Security Presidential Directive (HSPD), 185 Host-swapping diseases, 348, 361 Human anthrax vaccine, 57 Karnal bunt, 192 I Immunoassay strip tests, 328 Immunochromatographic (ICT) hand-held assays (HHAs), 151 Incident Command System (ICS), 218, 268b, 286 Incubation period, 32, 46 Infected premise (IP), 208 Infected zone (IZ), 206 Infectious substances, 259 Inhalation anthrax, 53–54, 323–324 Injectional anthrax, 55 Interagency working group (IWG), 331–332 International Air Transport Association (IATA), 258 J Japanese encephalitis (JE), 116–117 L Laboratory mishaps, 21–22 Laboratory Response Network (LRN), 319, 328 Low pathogenic avian influenza (LPAI), 222 M Mad cow disease, 225–227 Malaysian Ministry of Health (MOH), 116–117 Malta fever, 86–91 Mass prophylaxis, 300, 319 Mass spectroscopy, 328 Melioidosis, 92, 109 Middle East respiratory syndrome (MERS), 132 clinical presentation, 131 colorized transmission electron micrograph, 129, 130f diagnosis and treatment, 131 transmission, 130–131 Middle East respiratory syndrome coronavirus (MERS-CoV), 23–25, 24f Modern-day bioterrorism, 13–17, 17f N National Animal Health Emergency Management System (NAHEMS), 204 National Animal Health Reporting System (NAHRS), 189–191 National Incident Management System (NIMS), 218 Nationally notifiable infectious diseases (NNIDs), 253 National Response Framework (NRF), 271, 271b National Response Plan (NRP), 327 National Science Advisory Board for Biosecurity (NSABB), 297–299, 298f National Surveillance Unit (NSU), 189–191 Nipah virus, 115, 117, 132 clinical presentation, 117–118 diagnosis and treatment, 117–118 Malaysian Ministry of Health (MOH), 116–117 transmission electron micrographic image, 115, 116f O Office International des Epizooties/Epizootics (OIE), 187–188 Oropsylla montana, 58 Index P Pacific Northwest National Laboratory (PNNL), 147 Pandemic and All-Hazards Preparedness ­Reauthorization Act (PAHPRA), 296 Passive disease surveillance, 267 Penicillin, 56–57 Personal protective equipment (PPE), 274 Pestivirus, 223–224 Picornavirus, 219 Plague, 82 clinical manifestations bubonic plague, 60 pneumonic plague, 61–62 septicemic plague, 60, 60f epidemiology natural reservoirs, 58–59 transmission, 59 history, 57–58 incidence, United States, 59 Yersinia pestis, 57 Plum pox virus (PPV), 192–193 Pneumonic plague, Surat, India, 1994, 61–62 cordon sanitaire, 168 federally quarantinable diseases, 168, 169f Polymerase chain reaction (PCR), 151, 328 Portable fluorescence-based systems, 151 Postinfection treatment, 46 Presidential directives, 249–250 HSPD 4, 250 HSPD 9, 250 HSPD 10, 250–251 HSPD 18, 251–252 HSPD 21, 252 Prions, 37–38 Project BioShield, 293f Anthrax Vaccine Adsorbed (AVA), 296 Biomedical Advanced Research and Development Authority (BARDA), 294 Category A bioterror agents, 294–295 CBRN threats, 295 emergency use authorizations (EUAs), 296 Food and Drug Administration (FDA), 294 goals, 292 recent funding, 294–295, 295t Prophylactic treatment, 46 Prophylaxis, 300 Psittacosis, 109 in birds, 101–102 Chlamydophila psittaci, 99 clinical presentation, 101 diagnosis, 101 history, 99–100 incidence, 100, 100f transmission, 101 treatment, 101 Public Law 107–188, 249 Pulmonary glanders, 94 Pulmonary tularemia, 65–66 Q Q fever, 109 in biowarfare, 98b–99b clinical presentation, 97–98 Coxiella burnetii, 95 diagnosis, 98–99 history, 95–96 incidence, 96–97 transmission, 96 treatment, 98–99 R Rabbit fever, 62–66 Rajneeshees Salmonella incident, 1984, 165–167, 167f Recognition, avoidance, isolation, and notification (RAIN) agent detection technologies, 147–148 automated systems, 151 avoidance, 154–155, 155f biodetection equipment joint biological agent identification and diagnostic system test, 152, 152f test accuracy, 152–154 biological agent sample collection, 144–146, 145f biological test kits, 148–150, 149f–150f community response organizations, 137f first responder awareness level, 137 first responder operations level, 137 hazardous materials specialists, 138 hazardous materials technicians, 137 hazardous substance, 136 on-scene incident commanders, 138 critical elements, 144b, 145f detection system sensitivity, 148 specificity, 148 371 ... and natural disasters, such as laboratory mishaps and pandemics, respectively Biosecurity and biodefense concepts and programs are transparent to most people The reality is that biosecurity and. .. Understand the importance of the biological threat in its context of terrorism and weapons of mass destruction Discuss the terms biosecurity and biodefense and relate them to homeland security and. .. buildings, and Biosecurity and Bioterrorism ISBN 978-0-12-802029-6 http://dx.doi.org/10.1016/B978-0-12-802029-6.00001-3 Copyright © 2016 Elsevier Inc All rights reserved Biosecurity and Bioterrorism