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Executive Summary

The bombings of the World Trade Center in New York in 1993 and the Alfred P. Murrah Federal Building in Oklahoma City in 1995 have forced Americans to face the fact that terrorism is not something that happens only overseas. In addition, although the technology of producing and delivering chemical and biological weapons has existed for decades, the nerve gas attacks in Matsumoto in 1994 and Tokyo in 1995 by an apocalyptic religious cult and the subsequent revelation of the cult's attempts to acquire and use biological weapons have added a new dimension to plans for coping with terrorism. Traditional military approaches to battlefield detection of chemical and biological weapons and the protection and treatment of young healthy soldiers are not necessarily suitable or easily adapted for use by civilian health providers dealing with a heterogeneous population of casualties in a peacetime civilian setting.

For these reasons, the Institute of Medicine (IOM), in collaboration with the Commission on Life Sciences (CLS), was asked by the U.S. Department of Health and Human Services' Office of Emergency Preparedness (OEP) to:

collect and assess existing research, development, and technology information on detecting potential chemical and biological agents and protecting and treating both the targets of attack and health care providers, and

provide specific recommendations for priority research and development.



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Page 1 Executive Summary The bombings of the World Trade Center in New York in 1993 and the Alfred P. Murrah Federal Building in Oklahoma City in 1995 have forced Americans to face the fact that terrorism is not something that happens only overseas. In addition, although the technology of producing and delivering chemical and biological weapons has existed for decades, the nerve gas attacks in Matsumoto in 1994 and Tokyo in 1995 by an apocalyptic religious cult and the subsequent revelation of the cult's attempts to acquire and use biological weapons have added a new dimension to plans for coping with terrorism. Traditional military approaches to battlefield detection of chemical and biological weapons and the protection and treatment of young healthy soldiers are not necessarily suitable or easily adapted for use by civilian health providers dealing with a heterogeneous population of casualties in a peacetime civilian setting. For these reasons, the Institute of Medicine (IOM), in collaboration with the Commission on Life Sciences (CLS), was asked by the U.S. Department of Health and Human Services' Office of Emergency Preparedness (OEP) to: • collect and assess existing research, development, and technology information on detecting potential chemical and biological agents and protecting and treating both the targets of attack and health care providers, and • provide specific recommendations for priority research and development.

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Page 2 This report describes current civilian capabilities as well as ongoing and planned research and development (R&D) programs. It identifies some areas in which innovative R&D is clearly needed and assesses current R&D work for its applicability to coping with domestic terrorism. Assumptions Pre-incident intelligence about specific agents will always be important, for it is not possible to be prepared for all possible agents in all possible circumstances. As a practical matter, the committee has taken as its reference point the relatively short list of chemical and biological agents that are discussed in the U.S. Army's handbooks for the medical management of chemical and biological casualties: nerve agents, cyanides, phosgene, and vesicants such as sulfur mustard; the bacteria-produced poisons staphylococcal enterotoxin B and the botulinal toxins; the plant-derived toxin ricin; the fungal metabolite T-2 mycotoxin; and the infectious micro-organisms causing anthrax, brucellosis, plague, Q-fever, tularemia, smallpox, viral encephalitis, and hemorrhagic fever. As the body of the report notes, some are clearly more of a threat than others, and Appendixes C and D provide longer lists of potential chemical and biological agents, respectively, that have been assembled by other groups. For the above agents, a particularly threatening means of delivery, on which both military offensive and protective programs and the committee's considerations have concentrated, is as vapors or aerosols designed to cause poisoning or disease as a result of inhalation. Nevertheless, it would be a mistake to assume that terrorists will not be able to use other agents, even novel ones, or other means of delivery, including contamination of food or water supplies. As a practical measure, the committee chose to frame analyses of the possible utility of technology and R&D programs within three general scenarios. At one extreme is an overt attack rapidly producing significant casualties at a specific time and place—something similar to the Oklahoma City bombing, but involving a chemical or biological agent rather than, or in addition to, high explosives. Near the other extreme is a covert attack with an agent (for example, any of the bacteria or viruses alluded to in the previous paragraph) producing signs and symptoms in those exposed only after an incubation period of days or weeks, when the victims might be widely dispersed. The third scenario involves attempts at preemption, such as full-time monitoring of high-risk targets (e.g., the White House), deployment for specific events (Olympic Games, or the State-of-the-Union address), or simply dealing with a suspicious package. The committee recognizes that for nearly any specific locale, a terrorist attack of any sort is a very low-probability event, and for that reason

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Page 3 expensive or time-consuming actions in preparation for such events are extremely difficult for local governments to justify. Moreover, much of what could contribute to averting or mitigating casualties from terrorist chemical or biological attacks is urgently needed anyway to avert or mitigate severe hazards to health from toxic substances and prevailing or emerging infectious diseases of natural origin. As a result, the committee first gives special attention to developing recommendations for actions that will be valuable even if no attack ever occurs. A second type of recommendation focuses on specific actions that would be valuable in some of the more plausible scenarios. A third type of suggestion involves more generic, long-term research and development, although, even here, much of what needs to be done to deal with possible terrorist incidents will be of benefit to the nation's health irrespective of actual attack. Organization of the Report This report analyzes preparedness at four levels of medical intervention—local emergency response personnel, initial treatment facilities, state departments of emergency services and public health, and a variety of federal agencies. The specific capabilities assessed are pre-incident intelligence (Chapter 2); detection and identification of chemical and biological agents in the environment and in clinical samples from victims (Chapters 4 and 6); personal protective equipment (Chapter 3); recognizing covert exposures of a population (Chapter 5); mass-casualty decontamination and triage procedures (Chapter 7); availability, safety, and efficacy of drugs, vaccines, and other therapeutics (Chapter 8); prevention and treatment of psychological effects (Chapter 9); and computer related tools for training and operations (Chapter 10). A list of specific R&D needs is provided at the end of each chapter. These R&D needs, numbering 61 in all, are summarized in eight overarching recommendations. Pre-Incident Communication and Intelligence The response of even the most well prepared medical facilities will be markedly improved by advance notice from the law enforcement community. The latter understandably fear compromising ongoing investigations, but may not fully appreciate the substantial impact even very general information about possible incidents can have in facilitating a rapid and effective response by the medical community. Receipt of information concerning a possible mass-casualty event need not involve more than a few key individuals who can review the organization's seldom-used plan and begin to think about treatment options and where and how to obtain

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Page 4 needed antidotes and drugs, make hospital beds available on short notice, ensure adequate staffing levels. Recommendation 1. There needs to be a system in every state and major metropolitan area to ensure that medical facilities, including the state epidemiology office, receive information on actual, suspected, and potential terrorist activity. Specific R&D needs: • A formal communication network between the intelligence community and the medical community. • A national mechanism for the distribution of clinical data to the intelligence and medical communities after an actual event or exercise. Personal Protective Equipment Personal protective equipment (PPE) refers to clothing and respiratory apparatus designed to shield an individual from chemical, biological, or physical hazards. The ''universal precautions" (gloves, gown, mask, goggles, etc.) employed by medical personnel to prevent infections will generally provide protection from the biological agents under discussion, but it is difficult to say with confidence which, if any, civilian workers have suitable chemical PPE, because the testing and certification demanded by the Occupational Safety and Health Administration (OSHA) has not, until very recently, involved military nerve agents or vesicants, and military PPE that has been tested for protection against those agents generally does not have the testing and certification that would allow its use by civilian workers. Hospitals receive not only field-decontaminated patients but also "walk-ins" who may have bypassed field decontamination. Despite Joint Commission on Accreditation of Healthcare Organizations standards calling for hospitals to have hazardous materials (Hazmat) plans and conduct Hazmat training, two recent reviews have suggested that most hospitals in the United States are ill prepared to treat chemically contaminated patients. Recommendation 2. The committee endorses continued testing of civilian commercial products for suitability in incidents involving chemical warfare agents, but research is still needed addressing the bulk, weight, and heat stress imposed by current protective suits, developing a powered air respirator with greatly increased protection, and in providing detailed guidance for hospitals on dermal and respiratory protection.

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Page 5 Specific R&D needs: • Increased protection factors for respirators. • Protective suits with less bulk, less weight, and less heat stress. • Evaluation of the impact of occupational regulations governing use of personal protective equipment. • Uniform testing standards for protective suits for use in chemical agent incidents. • Guidelines for the selection and use of personal protective equipment in hospitals. • Alternatives to respirators for expedient use by the general public. Detection and Measurement of Chemical and Biological Agents Hazardous materials or "Hazmat" teams are routinely equipped with a variety of chemical detectors and monitoring kits, primarily employing chemical-specific tests indicating only the presence or absence of a suspected chemical or class of chemical. The most common detectors test for pesticides, chlorine, and cyanide, but not specifically for phosgene, vesicants, or nerve agents. Although chemical tests, detectors, and monitors used by the military are commercially available for civilian use, they have not been acquired by civilian organizations in appreciable numbers. Laboratory assays indicating exposure to cyanide and anticholinesterase compounds such as nerve agents are known and available at many hospitals, but there is no current clinical test for mustard agents or other vesicants. However, for all of these agents except mustard, individuals receiving potentially lethal doses usually develop signs and symptoms within a matter of minutes after exposure. Therefore, initial diagnosis and treatment are likely to be based on observations of signs and symptoms by the paramedic or other health care professional on the scene. Real-time detection and measurement of biological agents in the environment is more daunting, even for the military, because of the number of potential agents to be distinguished, the complex nature of the agents themselves, the myriad of similar microorganisms that are always present in the environment, and the impracticality of providing real time, continuous monitoring at even a fraction of the sites of potential concern. Few if any civilian organizations currently have, or can easily obtain, even a rudimentary capability in this area. Some serological, immunological, and nucleic acid assays are available for identifying all of the biological agents being considered in this report, and many hospitals and commercial laboratories have the necessary equipment and expertise to perform these and similar assays. However, these diseases are extremely rare in the United States, and for that

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Page 6 reason these laboratories do not perform these assays regularly. It therefore seems unlikely that many labs will be immediately prepared to conduct the specific analytical test needed to confirm the presence of the agent, even when the attending physician is astute enough to ask for the appropriate test. Recommendation 3. The civilian medical community must find ways to adapt the many new and emerging detection technologies to the spectrum of chemical and biological warfare agents. Public safety and rescue personnel, emergency medical personnel, and medical laboratories all need faster, simpler, cheaper, more accurate instrumentation for detecting and identifying a wide spectrum of toxic substances, including but not limited to military agents, in both the environment and in clinical samples from patients. The committee therefore recommends adopting military products in the short run and supporting basic research necessary to adapt civilian commercial products wherever possible in the long run. Specific R&D needs: • Evaluation of current Hazmat and EMS chemical detection equipment for ability to detect chemical warfare agents. • Miniaturized and less expensive gas chromatography/mass spectrometry technology for monitoring the environment within fixed medical facilities and patient transport vehicles. • Standard Operating Procedures for communicating chemical detection information from first responders to Hazmat teams, EMS teams, and hospitals. • Simple, rapid, and inexpensive methods of determining exposure to chemical agents from clinical samples. • Faster, cheaper, easier patient diagnostics that include rare potential bioterrorism agents. • Inexpensive or multipurpose biodetectors for environmental testing and monitoring. • Basic research on pathogenesis and microbial metabolism. • Scenario-specific testing of assay and detector performance. Recognizing Covert Exposure in a Population In the case of many biological agents, the time lag between exposure to a pathogen and the onset of symptoms may vary from hours to weeks, so effective response to a covert terrorist action will depend, not on fire and rescue personnel, but upon (a) the ability of individual clinicians,

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Page 7 perhaps widely scattered around a large metropolitan area, to identify and accurately diagnose an uncommon disease or toxin response and (b) a surveillance system for collecting reports of such cases that is actively monitored to catch disease outbreaks as they arise. The Centers for Disease Control and Prevention (CDC) operates a large number of infectious disease surveillance systems based on voluntary collaboration with state and local health departments, surveys, vital records, or registries. The best known of these systems, the National Notifiable Disease Surveillance System, currently includes several, but not all, of the diseases considered likely to be used in bioterrorism, and, like all passive surveillance systems, suffers from omissions and long-delayed reports. All of the systems depend upon confirmed diagnosis and are thus no help to a puzzled physician trying to arrive at a diagnosis. No federal funds are provided to state and local health departments to support these systems, and states' ability or willingness to support infectious disease surveillance has declined in recent years. CDC's Emerging Infections Program (EIP) is attempting to reverse this trend by making grants to state and local health departments for improving epidemiological and laboratory capability. Expanding the activities of these centers would be an excellent way to raise both the awareness of bioterrorism and the ability to respond to it. In most plausible chemical terrorism scenarios, the rapid onset of toxic effects would lead to highly localized collections of victims within minutes or hours, so the need for active surveillance is less pressing. A network of regional poison control centers is well established, however, and, if its personnel were educated about military chemical weapons, would be well suited for surveillance. Poison control centers are also obvious candidates to serve as regional data and resource coordinating centers in incidents involving multiple sites or large numbers of patients. Recommendation 4. Improvements in CDC, state, and local surveillance and epidemiology infrastructure must be undertaken immediately and supported on a long-term basis. Specific R&D needs: • Improvements in CDC, state, and local epidemiology and laboratory capability. • Educational/training needs of state and local health departments regarding all aspects of a biological or chemical terrorist incident. • Faster and more complete methods to facilitate access to experts and electronic disease reporting, from the health care provider level to global surveillance.

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Page 8 • Expanded pathogen "fingerprinting" of microbes likely to be used by terrorists and dissemination of the resulting library to cooperating regional laboratories. • Symptom-based, automated decision aids that would assist clinicians in the early identification of unusual diseases related to biological and chemical terrorism. Mass-Casualty Decontamination and Triage Procedures The removal of solid or liquid chemical agent from exposed individuals is the first step in preventing severe injury or death. Civilian Hazmat teams generally have basic decontamination plans in place, though proficiency may vary widely. Very few teams are staffed, equipped, or trained for mass decontamination. Hospitals need to be prepared to decontaminate patients, despite plans that call for field decontamination of all patients before transport to hospitals. However, few hospitals have formal decontamination facilities; even fewer have dedicated outdoor facilities or an easy way of expanding their decontamination operations in an event involving mass casualties. Recommendation 5. R&D in decontamination and triage should concentrate on operations research to identify methods and procedures for triage and rapid, effective, and inexpensive decontamination of large groups of people, equipment, and environments. Specific R&D needs: • The physical layout, equipment, and supply requirements for performing mass decon for ambulatory and nonambulatory patients of all ages and health in the field and in the hospital; • A standardized patient assessment and triage process for evaluating contaminated patients of all ages; • Optimal solution(s) for performing patient decon, including decon of mucous membranes and open wounds; • The benefit vs. the risk of removing patient clothing; • Effectiveness of removing agent from clothing by a showering process; • Showering time necessary to remove chemical agents; • Whether high-pressure/low-volume or low-pressure/high-volume spray is more appropriate for optimal cleaning of contaminated areas;

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Page 9 • The best methodology to employ in determining if a patient is "clean"; and • The psychological impact of undergoing decontamination on all age groups. Availability, Safety, and Efficacy of Drugs, Vaccines, and Other Therapeutics Vaccines against the agents of concern are, with only a couple of exceptions, of questionable utility, given the need to vaccinate far in advance of exposure. There are, in any case, licensed vaccines for only three of the biological agents being considered (anthrax, plague, and smallpox). There are few drugs of demonstrated effectiveness against any of the viral diseases of concern, nor are there safe and effective antitoxins to combat all the toxins on our short list (botulinum toxins A-F, SEB, ricin, and T-2 mycotoxin). Despite these shortfalls, given rapid response and/or accurate diagnosis, successful treatment of a very small number of individuals exposed to many of the chemical or biological agents is not beyond current medical capabilities. However, large numbers of casualties will quickly exhaust the limited supplies of antidotes, antibiotics, antitoxins, supportive medical equipment, and trained personnel that make that possible. Recommendation 6. Conduct operations research on stockpiling and distribution of currently available antidotes for nerve agents and cyanide and give high priority to research on an effective treatment for vesicant injuries, investigation of new anticonvulsants and potential antibody therapy for nerve agents, development of improved vaccines against both anthrax and smallpox, development of a new antismallpox drug, and research on broad spectrum antiviral and novel antibacterial drugs. Specific R&D needs: • See Box 1 for a complete listing by agent and priority. Prevention, Assessment, and Treatment of Psychological Effects Risks to victims and rescue and health care workers in such incidents include not only physical injury but psychological trauma. Research on post traumatic stress disorder (PTSD) has expanded far beyond studies of Vietnam veterans in the last 20 years, and includes a few studies of large-scale

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Page 10 BOX 1      R&D Needs in Availability, Safety, and Efficacy of Drugs and Other Therapies HIGH PRIORITY Nerve Agent • Antidote stockpiling and distribution system • Scavenger molecules for pretreatments and immediate post-exposure therapies Vesicants • An aggressive screening program focused on repairing or limiting injuries, especially airway injuries Anthrax • Vigorous national effort to develop, manufacture, and stockpile an improved vaccine Smallpox • Vigorous national effort to develop, manufacture, and stockpile an improved vaccine • Major program to develop new antismallpox drugs for therapy and/or prophylaxis Botulinum Toxins • Recombinant vaccines, monoclonal antibodies, and antibody fragments Non-specific Defenses Against Biological Agents • New specific and broad-spectrum anti-bacterial and anti-viral compounds MODERATE PRIORITY Nerve Agents • Intravenous or aerosol delivery of antidotes vs intramuscular injection • Development of new, more effective anticonvulstants for at toinjector applications Cyanide      • Dicobalt ethylene diamine tetraacetic acid, 4-dimethylaminophenol, and various aminophenones • Antidote stockpiling and distribution system • Risks and benefits of methemoglobin forming agents, hydroxocobalamin, and stroma free methemoglobin Phosgene • N-acetylcysteine and systemic antioxidant effects Viral Encephalitides and Viral Hemorrhagic Fevers • Antiviral drugs Botulinum Toxins • Botulinum immune globulin

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Page 11 LOW PRIORITY Brucellosis • Vaccine Pneumonic Plague • Second generation vaccine Q Fever • Genes and gene products involved in pathogenesis Staphylococcal Enterotoxin B (SEB) • Characterization of mechanism of action for vaccine development Ricin • Antiricin antibodies and formalin treated toxoid immunization Mycotoxin • Screening antivesicant treatments in animal models industrial accidents, among them, chemical spills. The latter studies have most often been epidemiological in nature, focusing on sequelae rather than treatment methods and their efficacy. A technique intended to prevent PTSD, Critical Incident Stress Debriefing (CISD), has gained wide acceptance among field emergency workers, and it can be expected that local police, fire, and emergency medical units will be familiar with the process and have plans to use it. Scientific evidence for its efficacy, however, is equivocal. At the federal level, the National Disaster Medical Service (NDMS) includes special Disaster Medical Assistance Teams specializing in mental health, and the Federal Emergency Management Agency (FEMA) funds the Crisis Counseling Assistance and Training Program (CCP). Few practitioners have experience with chemical or biological disasters, however, and fewer still are knowledgeable about chemical or biological warfare agents. Recommendation 7. Educational materials on chemical and biological agents are badly needed by both the general public and mental health professionals. Specific R&D needs: • Identify resource material on chemical/biological agents and enlist the help of mental health professional societies in developing a training program for mental health professionals

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Page 12 • Psychological screening methods for differentiating adjustment reactions after chem/bio attacks from more serious psychological illness. • Evaluation of techniques for preventing or ameliorating adverse psychological effects in emergency workers, victims, and near-victims. • Agent-specific information on risk assessment/threat perception by individuals and groups, and on risk communication by public officials. Computer-Related Tools for Training and Operations This section of the report identifies relevant computer-related tools and pertinent health-effects information that could be used by medical and other first responders to train regularly or use operationally to enhance and sustain capabilities for identifying and managing chemical or biological terrorist incidents. These tools will also decrease the need for participation in large exercises that can be disruptive, logistically complicated, expensive, and sometimes unproductive. Recommendation 8. The committee recommends support for computer software R&D in three areas: event reconstruction from medical data, dispersion prediction and hazard assessment, and decontamination and reoccupation decisions. Specific R&D needs: • Computer software for rapid reporting of unusual medical symptomology to public-health authorities and linking that data to both toxicological information and models of agent dispersion. • Examination and field testing of current and proposed atmospheric-dispersion models to determine which would be most suitable for the emergency management community. • Models of other possible vectors of dispersion (e.g., water, food, and transportation). • Customizable simulation software to provide interactive training for all personnel involved in management of chemical or biological terrorism incidents. • Information on the chemical, physical, and toxicological properties of the chemical and biological agents, in order to improve modeling of their environmental transport and fate and to better support recommendations on decontamination and reoccupation of affected property.

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Page 13 Conclusions The recommendations listed above and the R&D needs associated with them are the true conclusions of the study. There are, nevertheless, some general conclusions that pervade the report as a whole, and it may be useful to make them explicit here. The most basic of these is that terrorist incidents involving biological agents, especially infectious agents, are likely to be very different from those involving chemical agents and thus demand very different preparation and response (the myriad of "chemical/biological" response teams being developed at federal, state, and local levels are, in fact, almost entirely focused on detection, decontamination, and expedient treatment of chemical casualties). The second major conclusion that strongly influenced the committee's recommendations for research and development was the recognition that the military and civilian medical communities face very different situations with respect to prior knowledge about the identity of the enemy and the time and place of attack. Vaccination, for example, is an obvious preventive measure for a military force poised for combat against an enemy known or suspected to have a stockpile of certain biological weapons. The same holds true for deployment of chemical or biological detection systems and the use of highly specific antidotes and therapeutic and pretreatment drugs: with reasonable intelligence about the enemy's capabilities and proclivities, these tools can be put into action rapidly and confidently. The value of all of these diminishes considerably in the most probable civilian terrorism situations, in which the enemy, the agent, the time, and the place of attack are unknown. This difference, even more than differences in the physiology and psychology of civilian and military targets, influenced the committee to emphasize treatment over prevention, broad-spectrum drugs, detection with familiar or multiagent equipment if possible, laboratory diagnostics based on commercial technology, decontamination without agent-specific equipment or solutions, modification of familiar or multipurpose protective clothing and equipment, and even the advisability of pre-hospital treatment. Chapter 2 argues for including the medical community in the distribution of pre-incident intelligence to maximize medical response in dealing with chemical or biological incidents, but, important as that is, the time scale envisioned in those arguments is much too short for truly preventive measures like vaccination or the introduction of unfamiliar specialized equipment. Finally, for both chemical and biological incidents, there is an existing response framework within which modifications and enhancements can be incorporated. An attack with chemical agents is similar to the hazardous materials incidents that metropolitan public safety personnel contend

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Page 14 with regularly. A major mission of public health departments is prompt identification and suppression of infectious disease outbreaks, and poison control centers deal with poisonings from both chemical and biological sources on a daily basis. The committee feels very strongly that it is important to make these existing mechanisms the focus of efforts to improve the response of the medical community to additional, albeit very dangerous, toxic or infections materials.