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Introduction

Biological pathogens (for example, anthrax bacteria or the smallpox virus) or toxins produced by biological organisms (for example, botulinus toxin or staph enterotoxin) that are released intentionally or accidentally—or that occur naturally—can result in disease, fear, disruption to society, economic harm, diminished confidence in public and private institutions, and large-scale loss of life.

People or livestock can be exposed to these agents from inhalation, through the skin, or by the ingestion of contaminated food, feed, or water. After exposure to a pathogen or toxin used as a biological weapon, physical symptoms can be delayed and prove difficult to distinguish from naturally occurring illnesses. Similarly, crops can be exposed to biological weapons in several ways—at the seed stage, in the field, or after harvest.

The deciphering of the human genome sequence and elucidation of the complete genomes of many pathogens, the rapidly increasing knowledge of the molecular mechanisms of pathogenesis and of immune responses, and the development of new strategies for designing drugs and vaccines offer unprecedented opportunities for using science to counter bioterrorist threats. But these advances also allow science to be misused to create new agents of mass destruction.

Two kinds of biological terrorist threats must be envisioned. The first is the release of communicable infectious agents—like smallpox, Ebola, or foot-and-mouth disease—that can spread rapidly within communities and farmland through contact and have the potential, as does influenza, to spread around the world and cause epidemics. The second kind of threat consists of biological agents that may cause disease or death in individuals but generally may not be transmitted between individuals—the most familiar example being anthrax. In either case, some



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Countering Bioterrorism: The Role of Science and Technology 1 Introduction Biological pathogens (for example, anthrax bacteria or the smallpox virus) or toxins produced by biological organisms (for example, botulinus toxin or staph enterotoxin) that are released intentionally or accidentally—or that occur naturally—can result in disease, fear, disruption to society, economic harm, diminished confidence in public and private institutions, and large-scale loss of life. People or livestock can be exposed to these agents from inhalation, through the skin, or by the ingestion of contaminated food, feed, or water. After exposure to a pathogen or toxin used as a biological weapon, physical symptoms can be delayed and prove difficult to distinguish from naturally occurring illnesses. Similarly, crops can be exposed to biological weapons in several ways—at the seed stage, in the field, or after harvest. The deciphering of the human genome sequence and elucidation of the complete genomes of many pathogens, the rapidly increasing knowledge of the molecular mechanisms of pathogenesis and of immune responses, and the development of new strategies for designing drugs and vaccines offer unprecedented opportunities for using science to counter bioterrorist threats. But these advances also allow science to be misused to create new agents of mass destruction. Two kinds of biological terrorist threats must be envisioned. The first is the release of communicable infectious agents—like smallpox, Ebola, or foot-and-mouth disease—that can spread rapidly within communities and farmland through contact and have the potential, as does influenza, to spread around the world and cause epidemics. The second kind of threat consists of biological agents that may cause disease or death in individuals but generally may not be transmitted between individuals—the most familiar example being anthrax. In either case, some

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Countering Bioterrorism: The Role of Science and Technology agents may persist in the environment, as do anthrax spores, and continue to cause problems long after their release. In addition to naturally occurring pathogens, biological agents used offensively can be genetically engineered to resist current therapies and evade vaccine-induced immunity. Though it is vital that the molecular mechanisms by which classes of organisms cause disease (pathogenesis) be elucidated in order to understand and counter their effects, this is no simple matter. Preparedness for a biological attack against people, crops, or livestock is complicated by the large number of potential agents, the long incubation periods of some agents, and their potential for secondary transmission. Biological agents do not need to be weaponized for effective dissemination. Deliberate contamination of food looms as perhaps the easiest method, despite the recent focus on release of these agents as small-particle aerosols or volatile liquids. Moreover, because of its size and complexity, the U.S. food and agriculture system is vulnerable to deliberate attacks, particularly with foreign diseases that do not now occur domestically. Even without actual attack, plausible threats to infect populations or poison the food supply could, in and of themselves, damage the U.S. economy and reduce public confidence in the government’s ability to safeguard health and security. Recent experiences with the West Nile virus and anthrax spores in the United States, and with foot-and-mouth disease in the United Kingdom, offer practical lessons in human and agricultural outbreak detection, laboratory diagnosis, investigation, and response that might be useful in planning for future attacks involving biological terrorism (Fine and Layton, 2001). The experience with the West Nile virus outbreak highlighted the importance of communication and coordination between responding agencies (U.S. General Accounting Office, 2000). The GAO study noted that although the system worked, there were several obvious places for improvement. A single alert physician at a local hospital initiated the investigation early enough that an effective intervention was possible before the outbreak became widespread, but the investigation subsequently found many other cases, which were either not properly diagnosed or not reported to the health department. The GAO report concluded that much more systematic surveillance and reporting at the local level is needed. Similarly, improved communication among public health agencies, including those dealing with animal health, is needed. Increased laboratory capacity will also be important to an efficient and effective response to disease outbreaks (at first only one public health laboratory in the country was equipped to diagnose West Nile virus) (IOM, 2002). Moreover, these events raise vexing concerns about how many outbreaks could be managed at one time. The attacks of September 11, 2001, and the intentional release of anthrax spores shortly afterward also revealed vulnerabilities that are the results of long-term declines in the nation’s public health and agricultural infrastructures. The decline in the U.S. public health system is the result of its systematic dismantling

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Countering Bioterrorism: The Role of Science and Technology over time by Congress and the executive branch. In fact, the response of the Centers for Disease Control and Prevention (CDC) to the anthrax attacks was admirable given its limited resources and outdated communications system. CDC, together with state and local health departments, has provided this nation with an outstanding cadre of people who understand how to perform surveillance, prevention, and detection of infectious agents, whether they are endemic, emerging, or a result of bioterrorism. These agencies must be supplied with the tools and resources taken away from them in the past. Restoring the public health system of the United States should be the first order of business in the efforts to defend the nation against bioterrorism. THE NEED FOR APPROACHES WITH MULTIPLE BENEFITS Bioterrorism poses a unique challenge to the security of the U.S. population. A state-sponsored enterprise, or just a few individuals with specialized scientific skills and access to a laboratory, could easily and inexpensively produce a panoply of lethal biological weapons, although it is no trivial matter to disseminate or disperse such agents across large populations. Such operations may be difficult to detect because, in contrast to nuclear weapons, biological agents can be manufactured with ordinary pieces of equipment that are listed in commercial catalogues and are legitimately purchased for producing such things as chemicals, pharmaceuticals, or even beer. Fortunately, investments made to protect the country against bioterrorism will help protect the public’s health and the U.S. food supply from naturally occurring threats as well. Although it may be difficult to distinguish an introduced infectious disease from a naturally occurring one, the strategies to protect against either—requiring preparation and new scientific and technological approaches to surveillance, prevention, response, recovery, decontamination, and forensics—must be the same. Similarly, investments made to protect the country’s food supply against bioterrorism have the potential, and are even necessary, to protect it from more routine threats as well. Because the most likely breakthroughs will come from the study of both pathogenic and nonpathogenic bacteria and viruses, they should be studied together—indeed, the study of bioterrorism agents alone is likely to give a low return on investment. There are also indirect benefits associated with investments in protecting ourselves from bioterrorism. Money spent on research to develop new types of sensitive detectors and related monitors for biowarfare agents will almost certainly carry over to the public health sector in the form of rapid, improved diagnostics for disease. Money spent on coordinating and developing emergency response teams at the federal, state, and local levels will also bring better mechanisms for dealing with natural outbreaks of emerging diseases. Money spent on innovative surveillance approaches for detecting biowarfare attacks should improve

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Countering Bioterrorism: The Role of Science and Technology medical epidemiology. Money spent on vaccine research and delivery may help to buttress our limited capacity to protect civilian and military populations. CHANGING RESEARCH PARADIGM While this report was being prepared, the National Institute for Allergy and Infectious Diseases (NIAID) released a bioterrorism research agenda for rapidly addressing the most threatening biological agents (NIAID, 2002).1 Though important and commendable, this agenda lacks several major components—such as surveillance strategies, epidemiology of transmission, and the entire range of agricultural threats—needed for a comprehensive plan to counter bioterrorism. Consideration must also be given to preparing for still-uncharacterized threats and to assuring investment in long-term, broad-range strategies. These gaps must be filled, where not appropriate for NIAID action, by other federal agencies. CDC is the logical place for surveillance efforts, given its expertise, and therefore it will require additional resources. NIAID’s expanded role in bioterrorism research demands a focused effort to coordinate activities with other agencies—CDC, the Department of Defense (DOD), the Department of Energy (DOE), the Environmental Protection Agency (EPA), the U.S. Department of Agriculture (USDA), and the very recently proposed new Department of Homeland Security, for example. All of the governmental entities must seek expertise from private organizations, such as industry and professional societies with relevant expertise, for example, the Infectious Diseases Society of America and the American Society for Microbiology. It also demands that NIAID’s parent, the National Institutes of Health (NIH), find new mechanisms to fund research in this area, particularly for taking on long-range, highly managed, higher-risk projects and for moving the research at a faster pace. Likewise, CDC’s role is critical to the nation’s preparedness, but it must have the resources to improve its focus, strengthen its extramural capacity, and extend its international collaborations. National security also depends on public-private sector cooperation and communication and on an increased willingness to collaborate. ORGANIZATION OF THIS REPORT This report was published as Chapter 3 of the National Academies’ report, Making the National Safer: The Role of Science and Technology in Countering Terrorism (see Appendix A, Executive Summary of the full report). It is published here as a stand-alone report to focus on measures to counter bioterrorism. This report is organized into three chapters: (1) intelligence, surveillance, 1   See March 14, 2002, press release “NIAID Unveils Counter-Bioterrorism Research Agenda” at <http://www.niaid.nih.gov/newsroom/releases/biotagenda.htm>.

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Countering Bioterrorism: The Role of Science and Technology detection, and diagnosis; (2) prevention, response, and recovery; and (3) policy and implementation followed by concluding remarks. Each chapter describes the desired capabilities that could soon exist through better application of existing science and technology (and that might therefore have a near-term payoff) as well as desired capabilities that cannot now be provided through existing science and technology (S&T) but might be available in the future, given longer-term research and possibly more innovative funding and organizational approaches. The report focuses on research needs related to both human and agricultural health. Many of the recommendations apply equally to both areas while others are specific to one area or the other. In general, recommendations focus on R&D goals or organizational goals. The report concludes with recommendations about education and information dissemination, strengthening the public health and agriculture infrastructures, and organizing the research and development effort through improved policies, new funding models, and public–private partnerships.

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