1
Security Context for Geographical Expansion of the Biological Threat Reduction Program of the Department of Defense

The Department of Defense (DOD) has supported biological nonproliferation activities in seven countries of the former Soviet Union (FSU) during the past 12 years at a cost of about $800 million within the framework of the Cooperative Threat Reduction Program (see Table 1-1). These activities, referred to as the Biological Threat Reduction Program (BTRP), are scheduled to continue in the FSU for at least 5 years. At present, the largest activity is establishment of the Threat Agent Detection and Response system. This system is devoted to upgrading capabilities of partner governments to detect, characterize, and respond to outbreaks of infectious diseases, and particularly diseases associated with especially dangerous pathogens. BTRP also assists partner governments in developing biosecurity policies and regulations at the national level and provides training and technical assistance at the facility level. Finally, it supports cooperative research programs.

DOD anticipates reaching an annual level of BTRP expenditures of about $250 million during the next 5 years, including funding for activities in developing countries beyond the FSU.

With this experience as a starting point for understanding the role of BTRP, a brief discussion of relevant aspects of the security situation in developing countries outside the FSU is presented.

SUSTAINABLE SECURITY

A broadening of the traditional concept of national security to the longer term and more appropriate concept of sustainable security is presented in Box 1-1. Efforts to prevent and respond to the spread of infectious diseases, the theme of this report, cut across all three aspects of this expanded concept.



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1 Security Context for Geographical Expansion of the Biological Threat Reduction Program of the Department of Defense The Department of Defense (DOD) has supported biological nonprolifera- tion activities in seven countries of the former Soviet Union (FSU) during the past 12 years at a cost of about $800 million within the framework of the Coop- erative Threat Reduction Program (see Table 1-1). These activities, referred to as the Biological Threat Reduction Program (BTRP), are scheduled to continue in the FSU for at least 5 years. At present, the largest activity is establishment of the Threat Agent Detection and Response system. This system is devoted to upgrading capabilities of partner governments to detect, characterize, and respond to outbreaks of infectious diseases, and particularly diseases associated with especially dangerous pathogens. BTRP also assists partner governments in developing biosecurity policies and regulations at the national level and pro- vides training and technical assistance at the facility level. Finally, it supports cooperative research programs. DOD anticipates reaching an annual level of BTRP expenditures of about $250 million during the next 5 years, including funding for activities in develop- ing countries beyond the FSU. With this experience as a starting point for understanding the role of BTRP, a brief discussion of relevant aspects of the security situation in developing countries outside the FSU is presented. SUSTAINABLE SECURITY A broadening of the traditional concept of national security to the longer term and more appropriate concept of sustainable security is presented in Box 1-1. Efforts to prevent and respond to the spread of infectious diseases, the theme of this report, cut across all three aspects of this expanded concept. 

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 COUNTERING BIOLOGICAL THREATS TABLE 1-1 BTRP Funding, by Country FY 1997-2008 FY 2009 Total Azerbaijan $ 55,358,307 $ 23,831,377 $ 79,189,683 Armenia $ 1,723,385 $ 6,695,680 $ 8,419,065 Georgia $189,648,957 $ 50,437,397 $240,086,354 Kazakhstan $122,106,796 $ 31,338,716 $153,445,511 Russia $ 93,250,886 $ 7,554,086 $100,804,972 Ukraine $ 26,040,036 $ 44,384,216 $ 70,424,252 Uzbekistan $122,405,441 $ 20,775,431 $143,180,872 TOTAL $610,533,808 $185,016,902 $795,550,710 SOURCE: BTRP Program Manager, January 13, 2009. NOTE: Figures shown have been rounded to the nearest dollar. BOX 1-1 Sustainable Security “Leading in this new world will require a fundamental shift from our outdated notion of national security to a more modern concept of sustainable security, that is, our security as defined by the contours of a world gone global and shaped by our common humanity. Sustainable security combines three approaches: national security, or the safety of the United States; human security, or the well being and safety of people; and collective security, or the shared interests of one world.” SOURCE: Smith, Gayle E. 2008. In Search of Sustainable Security: Linking National Security, Human Security, and Collective Security to Protect America and Our World. Washington, D.C.: Center for American Progress. Available online at www.americanprogress.org/issues/2008/06/pdf/ sustainable_security1.pdf. In the low-income countries and in many areas of the middle-income coun- tries, the primary security issue for hundreds of millions of people is survival— enough food, adequate shelter, and tolerable levels of disease. Unemployment and underemployment are high in many areas of the world. Often impoverished populations must cope with wars as well as with insurgents, terrorists, and gangsters who ravage what little the populations have and frequently force poor people to move to unfamiliar surroundings. Neither the governments nor the general populations in these circumstances give priority to combating bioter- rorism, which until now has not been a threat in their countries. However, both the governments and the populations know that natu- rally occurring infectious diseases cause suffering and deaths. They can have

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 SECURITY CONTEXT FOR GEOGRAPHICAL EXPANSION OF BTRP debilitating impacts on society. Thus, the governments give priority for using their meager budgets and the limited contributions of international donors to combating diseases that have an impact on the daily lives of the people, includ- ing in some countries, for example, HIV/AIDS, malaria, and tuberculosis. Few, if any, budget allocations remain to prepare for a seemingly abstract threat of bioterrorism. Public health systems seldom function well in low-income countries where the ministries of health may not be considered “top-tier” ministries according to funding priorities. Ministries of agriculture also have serious funding short- falls. Even in middle-income countries, public health services are usually well below the level of services of developed countries. Throughout the developing countries, databases (if they exist) concerning the presence, trends, and impacts of diseases are often incomplete and unverifiable. The capability to use data to improve public health practice is poorly developed. Also, data may be politi- cally biased to help mask the inadequacies of governmental attention to health concerns of the people. Governments may have little capability to diagnose and confirm suspected disease outbreaks, whether they be in humans or animals. Many diseases may not be reported. Treatment, even when quality drugs are available, is usually spotty at best. Food shortages, unreliable electricity, limited refrigeration, pol- luted water, and the absence of sanitation may all contribute to an unacceptably high disease burden. As for human diseases, wealthy families sometimes travel abroad for health care. Laboratories may be equipped with modern instruments that will not be used in the near term because of a lack of trained technicians. Vaccines may become unusable because of storage problems, and immunizations may be spo- radic and incomplete. Also, infections acquired in hospitals can be rampant. Thus, it is not surprising that the capability of developing countries for addressing disease outbreaks initiated by terrorists are usually very weak, and in some countries essentially nonexistent. At the same time, promoting sustainable security that overcomes weaknesses that inhibit reliable reporting and treatment of diseases in distant lands is critical in advancing the far-ranging interests of the United States. We cannot afford to wait until an unusual disease burden becomes unacceptably high before we even know that a problem exists. (See Figure 1-1 concerning the communicable disease burdens in various areas of the world.) THREAT OF BIOTERRORISM AND COUNTRIES OF CONCERN The governments of the United States and other advanced countries increasingly view diseases that can lead not only to human suffering but also to political and economic destabilization as international security threats. In the age of expanding international travel and trade relations, biological pathogens

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 COUNTERING BIOLOGICAL THREATS 60 53 50 Percentage of Worldwide Totals 40 30 29 28 23 20 16 10 12 10 8 7 3 3 2 5 1 0 East South Sub-Saharan Latin Eastern Middle High-Income Asia Asia Africa America Europe East Countries and and and and Pacific Caribbean Central North Asia Africa Population Burden of communicable diseases FIGURE 1-1 Worldwide distribution of global burden of communicable diseases. SOURCE: The data presented in this figure were taken from the World Health Organization Web site on the global burden of disease, available online at www.who.int/healthinfo/global_burden_dis- R01457 ease/en/index.html. Accessed January 29, 2009. NOTE: The burden of communicable disease is a portion of the overall burden of disease. The Figure 1-1 overall burden of disease is assessed using the disability-adjusted life year, a time-based measure that combines years of life lost due to premature editable years of life lost due to time lived fully mortality and in states of less than full health. have become more mobile in reaching distant shores as infected travelers and contaminated food become unwanted byproducts of globalization. The day of the deliberately infected suicide terrorist riding in a crowded airplane through an international transportation system that is ill prepared to intercept the culprit may be close at hand. All the while, eliminating safe havens in develop- ing countries where terrorists could plot their future attacks in distant lands or could attack local populations has become a mantra of security experts in Washington, D.C., and many other capitals. Whether a dangerous infectious disease reaches the United States through a deliberate terrorist attack, through a sick passenger on international travel, or through the import of an animal for a zoo, the human suffering and the costs in

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 SECURITY CONTEXT FOR GEOGRAPHICAL EXPANSION OF BTRP coping with such an event can be high. As to economic impact, the Department of State estimates, for example, that a deliberate foot-and-mouth disease out- break at five Kansas stockyards could kill more than a million cattle, resulting in an economic loss of more than $1 billion. Even if an incident were contained within a limited geographic area, the social and economic impact when alarms are sent across the nation could be significant. The problems in combating bioterrorism in developing countries mirror the broader challenges of protecting global health and promoting interna- tional agricultural development. But special efforts are also needed to prevent, detect, respond to, and contain deliberately instigated outbreaks. On some occasions, intelligence services may play an important role in providing early warning about the plans of terrorists. But we cannot simply rely on the success of such efforts as bioterrorism enters the tool chests of dangerous groups and individuals. Box 1-2 summarizes the threat of bioterrorism as viewed by an important international official with responsibilities for uncovering terrorist networks. Box 1-3 presents a similar view that has been held by the Department of State for several years. As to naturally occurring biological threats, Box 1-4 highlights the pres- ence of especially dangerous pathogens in sub-Saharan Africa. Similar types of concerns are increasingly voiced on other continents as well. On a broader scale, reports from the World Health Organization, as exem- plified in Box 1-5, are equally disturbing. The foregoing observations underscore the importance of containing pathogens of many types while having robust detection and response systems. BOX 1-2 Availability of Dangerous Pathogens “There are many ways for terrorists to obtain deadly pathogens. They can buy or steal them from universities, research labs, pharmaceutical companies, military stockpiles, or commercial supply houses; acquire them from ‘friendly’ states or sympathizers; buy them on the black market; or produce the agents on their own. It is also becoming ever more possible for them to produce the pathogens as the volume and sophistication of the necessary information become increasingly accessible through publications, the internet, and other sources.” SOURCE: Robert K. Noble, Secretary General, Interpol. P. xvii In Kellman, B. 2007. Bioviolence: Preventing Biological Terror and Crime. New York: Cambridge University Press.

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0 COUNTERING BIOLOGICAL THREATS BOX 1-3 Threat of Global Bioterrorism “The threat of global bioterrorism is increasing. The gradual lowering of the techni- cal and financial barriers to purchase the materials, technologies, and expertise to develop biological weapons is linked to the worldwide growth in biotechnology; and nonstate actors and terrorist groups are now capable of obtaining and maliciously disseminating infectious disease agents. At the same time there has been a rise in highly organized and well financed transnational terrorist groups that have shown an interest in bioterrorism…. Although many nations have recently taken steps to improve their ability to detect and respond domestically to a bioterrorist incident, few programs are designed to prevent terrorists from acquiring, developing, and disseminating the technology and materials to produce biological weapons.” SOURCE: Department of State presentation of 2006 estimate to the committee, May 22, 2008. BOX 1-4 Spread of Especially Dangerous Pathogens in Sub-Saharan Africa • Ebola has been present in Sudan and the Republic of the Congo since 1976. • Marburg has been present in Kenya, Uganda, and Angola since 1980. • Yellow fever and dengue now exist in Kenya, Sudan, and Somalia. • Rift Valley fever reappeared in Kenya, Somalia, and Tanzania in 1997 and in 2006. • West Nile disease is present in Africa. SOURCE: Virologist, Central Veterinary Laboratory, Tanzania, presentation in Washington, D.C., July 2008. The following incidents underscore that the threat of bioterrorism is at the doorsteps of the world: • Anthrax letters were disseminated in the United States in 2001. • The 11th volume of al Qaeda’s Encyclopedia of Jihad is devoted to

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 SECURITY CONTEXT FOR GEOGRAPHICAL EXPANSION OF BTRP BOX 1-5 2007 World Health Organization Report “Infectious diseases are not only spreading faster, they appear to be emerging more quickly than ever before. Since the 1970s, newly emerging diseases have been iden- tified at the unprecedented rate of one or more per year. There are now nearly 40 diseases that were unknown a generation ago. In addition, during the last five years, WHO has verified more than 1100 epidemic events worldwide.” SOURCE: www.who.int/whr/2007/overview/en/index1.html. Accessed November 29, 2008. chemical and biological weapons.1 Also, plans for bioterrorism were set forth in documents recovered from al Qaeda training camps in 2001. 2 • An attempted theft targeted on the pathogen collection at the central reference laboratory for animal health in Indonesia in May 2007 was thwarted by security systems installed by the U.S. government.3 The infrastructure required to support a biological terrorism attack is strik- ingly smaller than the facilities and personnel resources that were developed to support biological warfare capabilities during the Cold War. Indeed, several years ago the U.S. Department of Health and Human Services demonstrated that it is possible to obtain through the Internet all of the needed components for a laboratory capable of dangerous genetic manipulation. 4 The infrastructure required to counter bioterrorism should be broadly based—from import controls, biosafety programs, and security of pathogen collections to detection, diagnostic, response, and treatment capabilities. The current focus of security experts is on compact attack scenarios and on defen- sive strategies that take advantage of existing networks for addressing human and agriculture diseases. Broad and numerous defensive countermeasures are an important theme throughout this report. 1 Kellman, B. 2007. P. 55 in Bioviolence: Preventing Biological Terror and Crime. New York: Cambridge University Press. 2 National Research Council Committee on Prevention of Proliferation of Biological Weapons. 2007. P. 15 in The Biological Threat Reduction Program of the Department of Defense: From For- eign Assistance to Sustainable Partnerships. Washington, D.C.: The National Academies Press. 3 Ibid. For additional views on the threat of bioterrorism, see Hoffman, Bruce. 2006. Pp. 274-280 in Inside Terrorism. New York: Columbia University Press. 4 Centers for Disease Control and Prevention (CDC) specialist briefing to the committee, Oc- tober 6, 2008.

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 COUNTERING BIOLOGICAL THREATS BOX 1-6 Al Qaeda Networks “Al Qaeda (AQ) and associated networks remained the greatest terrorist threat to the United States and it partners in 2007. . . . AQ and its affiliates seek to exploit local grievances for their own local and global purposes. They pursue their own goals, often at large personal cost to the local population. These networks are adaptive, quickly evolving new methods in response to countermeasures. AQ utilizes terrorism, as well as subversion, propaganda, and open warfare; it seeks weapons of mass destruction in order to inflict the maximum possible damage on anyone who stands in its way, including other Muslims, and/or elders, women, and children.” SOURCE: U.S. Department of State. 2008. Country Reports on Terrorism, Trends in 2007, p. 7. Many biological pathogens are of near-term concern. The anthrax letters have illustrated the simplicity of disseminating a deadly agent, while the spread of avian influenza has highlighted the ease with which a virus can circulate through large regions of the globe. As to other possible schemes of terrorists, botulinum toxin is lethal if ingested through contaminated food products, with the safety of milk supplies of special concern. There are no vaccines for many livestock diseases, which could spread rapidly if introduced into feed lots in developing countries as well as in the industrialized countries. Introducing diseases onto vulnerable crops seems relatively easy to execute and particularly dangerous in countries where high concentrations of monocultures with limited genetic diversity are susceptible to the spread of contagious plant diseases. 5 At the top of the list of terrorism concerns of the Department of State are the activities of al Qaeda and related organizations, as indicated in Box 1-6. As al Qaeda continues to spawn cells that operate with considerable independence in several countries, the capabilities and intent to do harm internationally of such offshoot organizations spread accordingly. While some terrorist groups continue to look to al Qaeda leadership and expertise for guidance, others may be developing their own capabilities in the biological area as well as in the more traditional bullets-and-bombs area. The Commission on the Prevention of Weapons of Mass Destruction, Proliferation, and Terrorism has stated that it is “more likely than not that a 5 According to an Agency for International Development (USAID) briefing to the committee on July 24, 2008, USAID reports that wheat rust UG 99 spread from Uganda and Kenya in 1998 to Ethiopia in 2003 to Yemen and Sudan in 2006 and to Iran in 2008, with the possibility of spread- ing further into Saudi Arabia, Egypt, India, and Afghanistan in the near future—and without the involvement of bioterrorists.

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 SECURITY CONTEXT FOR GEOGRAPHICAL EXPANSION OF BTRP weapon of mass destruction will be used in a terrorist attack somewhere in the world by the end of 2013.” Furthermore, focusing specifically on bioterrorism, “the Commission further believes that terrorists are more likely to be able to obtain and use a biological weapon than a nuclear weapon. The Commission believes that the U.S. government needs to move more aggressively to limit the proliferation of biological weapons and reduce the prospect of a bioterror attack.”6 There is a growing list of countries where biosecurity vulnerabilities and the presence of dissident groups come together. Among the countries beyond the FSU that have been mentioned by U.S. experts at meetings of the com- mittee as high on their biological threat indexes are the following: Indonesia, Pakistan, the Philippines, Malaysia, Thailand, Libya, China, Taiwan, Vietnam, India, Sri Lanka, Mongolia, Nigeria, Kenya, Democratic Republic of the Congo (DRC), South Africa, and Mexico. Many other developing countries also have vulnerabilities that could be exploited by bioterrorists. 7 A variety of specialists who are familiar with biosecurity-related conditions in developing countries have expressed the view to the committee that many developing countries are highly vulnerable. As discussed in the introduction of this report, the committee has not attempted to prioritize the countries where the international community or BTRP should focus attention. Governments of all developing countries should be encouraged to balance the risks associ- ated with possible bioterrorism-related activities now and in the future with the many other types of health, security, and economic challenges they face. Such balancing should help them decide how to use their limited resources to improve the well-being of their populations and whether to seek international assistance in the area of biosecurity. Upon request, U.S. and other experts should be able to assist governments of developing countries in clarifying the costs and benefits of steps to reduce the likelihood of bioterrorism attacks and to limit the consequences of such attacks should they occur. Biosecurity experts sometimes compare the large international and national programs devoted to countering proliferation of nuclear weapons with the smaller programs to counter proliferation of biological weapons. They argue that biological risks are just as great, or even greater, and deserve comparable attention. One specialist has offered the analysis set forth in Table 1-2 to sup- port this position. 6 Commission on the Prevention of Weapons of Mass Destruction, Proliferation, and Terrorism. 2008. P. xv in World at Risk: The Report of the Commission on the Prevention of Weapons of Mass Destruction, Proliferation, and Terrorism. New York: Vintage Books. 7 The committee is unaware of publicly available, U.S. government-wide criteria for ranking countries of concern, although the Department of State, CDC, and other organizations are develop- ing their own models in this regard. See, for example, International Biological Threat Reduction Program, Sandia National Laboratories. 2009. Global Biological Threat Prioritization Pilot Study. Unclassified summary provided to the committee, January 12, 2009.

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 COUNTERING BIOLOGICAL THREATS TABLE 1-2 Characteristics of Fissile Materials and Pathogens Fissile Materials Biological Pathogens Do not exist in nature Generally found in nature Nonliving, synthetic Living, replicative Difficult and costly to produce Easy and cheap to produce Not diverse: plutonium and highly Highly diverse: more than 20 pathogens are enriched uranium are the only suitable for biological warfare fissile materials used in nuclear weapons Can be inventoried and tracked in a Because pathogens reproduce, inventory quantitative manner control is unreliable Can be detected at a distance from the Cannot be detected at a distance with emission of ionizing radiation available technologies Weapons-grade material are stored at a Pathogens are present in many types of limited number of military nuclear facilities and at multiple locations within sites a facility Few nonmilitary applications (such as Many legitimate applications in biomedical research reactors, thermoelectric research and the pharmaceutical and generators, and production of biotechnology industries radioisotopes) SOURCE: Tucker, J. B. 2003. Preventing the misuse of pathogens: the need for global biosecurity standards. Arms Control Today 33(June):3-10. Available online at www.armscontrol.org/act/00_ 0/tucker_june0. Clearly, containing the threat of biological weapons deserves a high level of attention by the international community. The United States has the experience, skills, and technologies to address the threat as well as being a potential target of embittered individuals or groups of vengeful extremists with newly acquired biological capabilities. At the same time, overall capabilities to capitalize economically on the revolution in the life sciences or even to use more traditional achievements of biology laboratories in the more than 130 developing countries are highly vari- able. For example, Brazil is in a class by itself in pressing forward with biotech- nology in Latin America. Singapore is leaving its neighbors in its scientific wake in Asia. Turkey and Egypt are ahead of many of their neighbors in the Middle East. South Africa is far ahead in promoting modern biotechnology in Africa. Also, within an individual developing country, conditions to contain bio- logical assets are usually uneven. For example, in some countries a central modern biotechnology facility stands apart from more rudimentary facilities located in areas distant from this central facility. In Pakistan, both the research productivity and the level of effective security at the country’s dozens of biosci- ence and biotechnology facilities vary considerably. Finally, the DRC and the Republic of the Congo are endemic with some of the deadliest microbial agents (for example, Ebola, monkeypox, plague, and

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 SECURITY CONTEXT FOR GEOGRAPHICAL EXPANSION OF BTRP anthrax, among others). Yet none of the three national laboratories are capable of characterizing such pathogens. THE GLOBAL SPREAD OF BIOTECHNOLOGY Rapid scientific advances in the life sciences and in biotechnology and the increasing global dissemination of research results will continue to make impor- tant contributions to improving global health and international agriculture for the foreseeable future. Medical researchers are using ever more sophisticated techniques to manipulate microorganisms in their efforts to combat infectious diseases through more effective vaccines and drugs and through improved diagnostic methods. Agricultural scientists are also using newly developed approaches to create inexpensive scientific platforms for developing important animal vaccines and antibodies. At the same time, public health and veterinary applications are not the only results of the revolution in life sciences as new advances are increasingly realized in the search for improved crop productivity, industrial enzymes, and environmental remediation methods (see Box 1-7). There is also a dark side to such impressive accomplishments, including the possible acquisition of dangerous microbes and viruses by groups that plan to use them as bioterrorism agents. As research laboratories and biotechnology firms increase in number and size throughout the world to address human and agricultural diseases, new pathogens that can cause human catastrophes may be uncovered. In particular, genetic engineering and related technologies may cre- ate more virulent pathogens that resist current methods of preventing diseases through vaccines and drugs. Most advanced bioscience research, development, and production activi- ties will be concentrated in the industrialized countries for the near future. To a limited degree, foreign pharmaceutical companies and other multinational firms are also investing in biotechnology in a few developing countries. In these countries, government officials and local scientists are hoping not to fall still farther behind the more prosperous countries on the economic and scientific development scales. BOX 1-7 Rapid Advance of Biotechnology “Starting in 2002, it took 2 years for a team to synthesize the polio virus. In 2005, it took 2 weeks for a team to synthesize a virus of comparable length.” SOURCE: International Council for the Life Sciences, briefing to the committee, July 24, 2008.

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 COUNTERING BIOLOGICAL THREATS An important concern is the possibility that a firm in an advanced country with weak controls on exports of biological materials might simply sell danger- ous genetic materials to firms in developing countries where skilled scientists could assemble fragments into particularly potent pathogens. Such scenarios are perhaps being considered by groups with hostile intentions. These scenarios send a warning that strengthening the control of international commerce in biotechnology products is essential. Meanwhile, the number of biology specialists from the developing coun- tries who are being trained in modern laboratories in the more advanced countries is on the rise. A few of the most talented are returning to their home countries. Too often, however, they may find only unacceptably low salaries and inadequate facilities for continuing their scientific endeavors in poverty-stricken countries. The future of this underutilized talent pool should be of concern. A recent report recommended the five approaches set forth below in bold print to help guide the U.S. government’s efforts to promote responsible use of biological assets in the United States.8 The recommendations have relevance in developing countries as well. It would be useful to elaborate them as neces- sary for implementation at the international level. The brief discussion of the following approaches is a first step in this direction. • Policies and practices should, to the maximum extent possible, pro- mote the free and open exchange of information in the life sciences. Transpar- ency that accompanies exchanges of information can help provide international confidence that the intent of individuals and groups engaged in biological activities is to use biological assets for appropriate, and not for malevolent, purposes. However, security measures to contain scientific advances with dual- use implications may prevent international exchanges of some information and thereby inhibit scientific advances while raising suspicion as to why information is being withheld. Nevertheless, exchange of information to the extent possible is still a desirable policy. • A broader perspective of the number and types of pathogens that pose potential dangers should be adopted as to the biological threat spectrum. As discussed in Chapter 3, BTRP, along with other U.S. government nonprolif- eration programs, uses a core list of a limited number of especially dangerous pathogens in its efforts to combat bioterrorism in distant countries. But bioter- rorism could involve a much wider range of pathogens beyond this list. Also, partner governments in developing countries are most interested in engagement when cooperative activities focus on the pathogens that are causing day-to-day problems for human and agricultural health even though these pathogens may 8 Institute of Medicine Board on Global Health. 2006. Globalization, Biosecurity, and the Future of the Life Sciences. Washington, D.C.: The National Academies Press. Available online at www. nap.edu/catalog.php?record_id=. Accessed December 2, 2008.

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 SECURITY CONTEXT FOR GEOGRAPHICAL EXPANSION OF BTRP not be well suited as bioterrorism agents. In response, BTRP has demonstrated flexibility in adding avian influenza, swine flu, cholera, and other diseases of day-to-day concern to its list of target diseases. Continued expansion of the list will be very important in the developing countries beyond the FSU, where bioterrorism concerns often take a very distant backseat to demands to address common illnesses. Indeed, in some settings, the pathogen-specific approach should give way to a more generic approach to strengthen surveillance and research systems that address a range of pathogens. • The scientific and technical expertise within and across the security community should be strengthened. The security community in most develop- ing countries is not scientifically equipped to adequately assess the risks associ- ated with pathogens or to effectively enforce appropriate biosecurity regula- tions even if they are in place. Too often in everyday practice local officials may not recognize significant risks. On the other hand, they may overestimate risks and discourage research or production practices that are not of serious security concern simply because they do not have the expertise to make nuanced judg- ments concerning risks. • A common culture of awareness and a shared sense of responsibility within the global community of life science specialists should be adopted and promoted. Unfortunately, many officials and scientists in developing countries may not fully appreciate the importance of appropriate laboratory measures or do not have the time or resources to devote to measures that help ensure appropriate security arrangements. Interactions with counterparts in the more advanced countries who routinely implement biosecurity procedures, and par- ticularly biosafety measures, can help them assess the extent of the problems in their countries and identify appropriate measures to respond to both near-term and long-term biological threats. • The public health infrastructure and existing response and recovery capabilities should be strengthened. In developing countries, public health services are usually weak, and many years and considerable investments may be needed to upgrade such capabilities to a level of international acceptability. An effective public health system is an essential step in developing the capability to combat bioterrorism. The growing access to highly sophisticated tools that could be used to construct biological weapons is expanding the character of the biological threat. In this regard, the National Science Advisory Board for Biosecurity has recom- mended that careful consideration be given to knowledge, products, or tech- nologies that could pose threats on many fronts (see Box 1-8). While not of immediate likelihood in most developing countries, major scientific advances in biotechnology are important in the long term. Of spe- cial importance are India and China, which have made considerable progress toward establishing research- and innovation-based biotechnology sectors.

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 COUNTERING BIOLOGICAL THREATS BOX 1-8 Dual-Use Threat Criteria Research products (including techniques and technologies) that have the potential to inflict harm or damage to public health or economies may include the following elements or characteristics: • Enhance the harmful consequences of a biological agent or toxin • Disrupt immunity or the effectiveness of an immunization without clinical and agricultural justification • Confer to a biological agent or toxin resistance to clinically and/or agricultur- ally useful prophylactic or therapeutic interventions against that agent or toxin, or facilitate their ability to evade detection methodologies • Increase the stability, transmissibility, or the ability to disseminate a biological agent or toxin • Alter the host range or tropism of a biological agent or toxin • Enhance the susceptibility of a host population • Generate a novel pathogenic agent or toxin, or reconstitute an eradicated or extinct biological agent SOURCE: NSABB Draft Guidance Documents, July 2006, p. 4. Available online at oba.od.nih.gov/ biosecurity/PDF/NSABB_Draft_Guidance_Documents_27Sep06_(12_11_2006).pdf. Accessed November 29, 2008. Each of these countries has several vaccines and drugs on the market. While the efficacy and safety of such products produced in developing countries are of concern, this topic was beyond the scope of this study.9 In short, specialists involved in biotechnology activities should be aware of the potential security implications as well as the business opportunities that are accompanying the rapid advances in the life sciences.10 9 Frew, S. E., H. E. Kettler, and P. A. Singer. 2008. The Indian and Chinese health biotechnology industries: Potential champions of global health. Health Affairs 27(4):1029-1041. 10 For an overview of biotechnology interests in developing countries, see United Nations Confer- ence on Trade and Development, Division on Investment Technology and Enterprise Development. 2002. Key Issues in Biotechnology. New York and Geneva: United Nations. Available online at www.unctad.org/en/docs/poitetebd0.en.pdf. Accessed November 30, 2008.

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 SECURITY CONTEXT FOR GEOGRAPHICAL EXPANSION OF BTRP CONVERGENCE OF CHEMISTRY AND BIOLOGY Biologists and chemists have long recognized the overlap between their disciplines. Now, advances in the life sciences and biotechnology are resulting in a considerably expanded overlap. This is due to several types of advances. Genome mapping and synthetic biology have facilitated increased understand- ing of biological systems. Automation of the synthesis and screening of chemi- cal compounds has enabled laboratories to assess many new structures with an enhanced understanding of the characteristics of chemicals of biological origin. Also, the increased ability to observe chemical action at the cellular level brings the two disciplines closer together, as does the application of nanotechnology to deliver pharmaceuticals to specific cells. Consequently, the overlapping measures to control the proliferation of biological and chemical weapons are increasingly recognized in the interna- tional arena. In the past, implementation activities pursuant to the chemical and biological arms control agreements have consistently been kept separate since biological issues are more difficult to address than chemical issues. This difficulty is particularly acute with regard to verification of international agree- ments. Maintaining this separation will be increasingly difficult with advances in research and production activities. In short, cooperative programs designed to control only dangerous chemi- cal agents or only dangerous biological agents will continue to be important. But sharp separation of these two approaches may not be the most effective approach in reducing the risks of terrorism resulting from advances in chem- istry and biology.11 Is the expanding overlap of chemistry and biology of significance in devel- oping countries? In many settings, probably not. But the overlap may have important ramifications when countries are seeking to expand their research capabilities in major ways. The governments of these countries will most likely have a single unit that is responsible for compliance with both chemical and biological obligations. At the same time, they may lack technically qualified staff to adequately monitor activities, particularly in the intersecting areas of biology and chemistry. INTERNATIONAL BIOSECURITY AGREEMENTS, GUIDELINES, AND CODES OF CONDUCT Several international agreements and other international documents are designed to prevent the deliberate or accidental spreading of biological agents of concern. Several of these agreements and documents are highlighted below. 11Trapp, R. 2008. Advances in science and technology and the Chemical Weapons Convention. Arms Control Today 38(March):18-22. Available online at www.armscontrol.org/act/00_0/ Trapp. Accessed November 30, 2008.

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0 COUNTERING BIOLOGICAL THREATS The Biological Weapons Convention (BWC), which entered into force in 1972, was an international nonproliferation landmark. It outlawed the devel- opment and production of biological weapons. It also required destruction of existing stocks of such weapons. The language of the BWC prohibits the fol- lowing activities by states parties to the BWC: . . . in any circumstances to develop, produce, stockpile or otherwise acquire or retain microbial or other biological agents or toxins, whatever their origin or method of pro- duction, of types and in quantities that have no justification for prophylactic, protective, or other peaceful purposes. . . .12 Difficulties have frequently arisen at international meetings and in other settings in interpreting “peaceful purposes,” a concept that is linked to intent. Also, problems in elaborating the mechanisms for ensuring compliance with the BWC have been insurmountable. Nevertheless, the BWC, which has more than 160 states parties as of February 2009, has set at least a low bar for preventing malevolent use of biology by governments.13 In a more general sense, in 2004 the UN Security Council adopted a nonproliferation resolution (Resolution 1540) calling for all states to refrain from supporting by any means nonstate actors that attempt to acquire, use, or transfer nuclear, chemical, or biological weapons and their delivery systems. Of special interest is the following section of the resolution: . . . the Council decided that all States would establish domestic controls to prevent the proliferation of such weapons [of mass destruction] and means of delivery, in particular for terrorist purposes, including by establishing appropriate controls over related mate- rials, and adopt legislative measures in that respect. The Council called on all States to promote dialogues and cooperation on non-proliferation in addressing the threat posed by proliferation of nuclear, chemical, and biological weapons and their delivery systems. Further to counter that threat, it called upon all States according to their national legisla- tion and consistent with international law to cooperate in preventing illicit trafficking in such weapons, means of delivery, and related materials.14 Another major international achievement has been development of inter- national guidelines that are designed to limit the proliferation of pathogens and of critical equipment needed for the production of some classes of biological agents. Within the informal setting of the Australia Group, more than 40 of the world’s leading industrial countries have developed these guidelines. Of 12 Convention on the Prohibition of the Development, Production and Stockpiling of Bacterio- logical (Biological) and Toxin Weapons and on Their Destruction: Article I. 1972. Available online at www.opbw.org/conention/documents/btwctext.pdf. Accessed November 30, 2008. 13 The complete list of participants and nonsignatories may be found online at www.unog. ch/0EE00/(httpPages)/BECBBEA0BC00FDC?OpenDocument. Accessed November 27, 2008. 14 United Nations Security Council Resolution 1540. 2004. Press Release SC/8076. Available online at www.un.org/News/Press/docs/00/sc0.doc.htm. Accessed November 26, 2008.

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 SECURITY CONTEXT FOR GEOGRAPHICAL EXPANSION OF BTRP course, many of the items on the control list have dual-use capabilities, and the impact of the implementation of the guidelines on legitimate trade activities is a constant concern. A third development of special relevance to this report is the promulgation of the World Health Organization (WHO) 2005 International Health Regula- tions. The full document may be found on the WHO Web site at www.who. int/csr/ihr/en. A summary is included in this report as Appendix H. These widely accepted regulations provide a framework for responsibly addressing and reporting the growing spread of human diseases, whatever their source. In this regard, the WHO has reported more than 1,100 disease outbreaks during the past 7 years. Also of importance is the Cartagena Protocol, with more than 150 parties (the full text of the protocol may be found online at www.cbd.int/biosafety/pro- tocol.asp). It is intended to protect biological resources from the potential risks posed by living modified organisms resulting from modern biotechnology. The protocol has encouraged many developing countries to introduce biosafety laws and regulations. The United States and a handful of other major countries are not signatories to this agreement, which they believe unnecessarily constrains development of important new agricultural products. As indicated in Box 1-9, developing countries may have serious implementation problems. Other international actions that warrant mention are the World Trade Organization Phytosanitary Standards and the Codex Alimentarius Standards, which help prevent the spread of contaminants in international trade; the Inter- national Plant Protection Convention, which helps control exports and imports that might spread pests (available online at www.ippc.int/IPP/En/default.jsp); and the Declaration of Helsinki on the Conduct of Clinical Research (available online at www.bioscience.org/guides/decthels.htm). As international concerns about biosecurity grow, many organizations have also become active in developing codes of conduct and other statements of BOX 1-9 Implementing the Cartagena Protocol “Developing countries face particular challenges with the Cartagena Protocol because their capacity to implement, monitor, and enforce biosafety laws remains weak. They also need to address the issues in the Protocol that are left to national discretion, and they must balance their rights and obligations under the Protocol with their commit- ments under the World Trade Organization.” SOURCE: Senior Pakistani official, presentation in Washington, D.C., July 2008.

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 COUNTERING BIOLOGICAL THREATS BOX 1-10 Selected Codes of Conducta • UNESCO Declaration of Science and the Use of Scientific Knowledge, adopted by the World Conference on Science, July 12, 1999 • International Committee of the Red Cross, Preventing Hostile Use of the Life Sciences: From Ethics and Law to Best Practice, November 11, 2004 • American Society for Microbiology, Code of Ethics 2005 • American Medical Association, Guidelines to Prevent Malevolent Use of Bio- medical Research, June 2004 • Council for Responsible Genetics, Campaign for the Peaceful Development of the Biological Sciences • InterAcademy Panel on International Issues, Statement on Biosecurity, December 1, 2005 • International Union of Microbiological Scientists, Code of Ethics against Mis- use of Scientific Knowledge, Research, and Resources, April 28, 2006 • Global BioBusiness, Code of Conduct for Life Sciences Professionals, Uni- versity of Southern California Global Business Initiative • National Science Advisory Board for Biosecurity, Life Scientists: Core Responsi- bilities Regarding Dual Use Research of Concern, July 2006 draft a The Codes Archive of the Organization for Economic Cooperation and Development lists other codes online at www.biosecuritycodes.org/codes_archive.htm. Accessed November 26, 2008. SOURCE: Adapted from Kellman, B. 2007. Bioviolence: Preventing Biological Terror and Crime. New York: Cambridge University Press, p. 141. principles for consideration by governments and nongovernmental groups. Box 1-10 identifies several codes of conduct and related types of international pronouncements. DOD’S INVOLVEMENT IN DEVELOPING COUNTRIES In 1997, in accordance with a decision of President Clinton, DOD expanded its role in addressing threats to the United States and to other nations posed by infectious diseases that were emerging or reemerging throughout the world.15 Requirements for demonstrating direct linkages between proposed DOD health-related activities abroad and the health of U.S. armed forces personnel deployed abroad were to be relaxed. This expanded international 15 Presidential Decision Directive NSTC-7. 1996.

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 SECURITY CONTEXT FOR GEOGRAPHICAL EXPANSION OF BTRP mandate for DOD in the medical field was soon buttressed by a National Intel- ligence Estimate (NIE) in 2001 that stated the following: Emerging infectious diseases are a global security issue because they have the capacity to harm U.S. interests abroad through destabilizing key institutions, obstructing trade and human migration, slowing or reversing economic growth, fomenting social unrest, and complicating U.S. response to refugee situations by increasing the demand for humanitarian intervention and through their association with biological terrorism and warfare.16 DOD has underscored the validity of this NIE by pointing to the interna- tional significance of the quick emergence of severe acute respiratory syndrome in 2003 and avian influenza in 2005.17 From DOD’s perspective, infectious diseases are a national security issue, and DOD must respond to the threat that they pose. Other U.S. government departments also consider such outbreaks as national security issues. Against this background, DOD continues to strengthen its overseas public health capabilities, pointing, for example, to successes in improving diagnostic capabilities for malaria, dengue, and respiratory diseases. In recent years, DOD has carried out medical activities in more than 60 developing countries, rely- ing heavily on its 5 overseas laboratories as well as other resources temporarily deployed abroad.18 In short, DOD has a well-developed medical system within the U.S. government with a mission of health surveillance through the monitor- ing of infectious disease outbreaks using modern laboratory methods for detec- tion coupled with standard epidemiological surveillance methods. 19 This growing activity by DOD, directed in large measure to disease sur- veillance and response, reflects DOD’s view of the significance of this national security issue. An important part of the DOD activity is development of new drugs and vaccines for use against malaria, dengue, diarrheal diseases, menin- gitis, and adenovirus. This interpretation of “national security” is only one of several factors that need to be taken into account as to whether DOD should become involved in specific country situations. Appendix E describes the missions and highlights particularly relevant activities of 15 DOD entities that have activities in developing countries outside the FSU. BTRP has in large measure operated independently from many of the other health-related programs supported by DOD. There have been impor- tant exceptions; and now BTRP is increasingly engaging several other DOD organizations, particularly Walter Reed Army Institute of Research, the U.S. 16 U.S. Department of Defense. 2007. P. 3 in DoD Global Emerging Infections Surveillance and Response System Annual Report Fiscal Year 2006. Silver Spring, MD: DOD. 17 DOD. Global Emerging Infections. 18 Ibid., p. 68. 19 Ibid., p. 5.

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 COUNTERING BIOLOGICAL THREATS Army Medical Research Institute of Infectious Diseases, and a DOD overseas laboratory, the U.S. Naval Medical Research Unit 3 (NAMRU-3), in its activities in the FSU. Still, the arrangements have been largely ad hoc and often are not well integrated, as discussed in Chapter 3. AN EXPANDED PROGRAM TO ENHANCE BIOSECURITY Recommendation 1-1: DOD should, within the U.S. government’s evolving global biological engagement strategy, promptly expand BTRP into selected developing countries beyond the FSU. As noted previously, potent ingredients for bioterrorism attacks are becom- ing more available to vengeful parties in developing countries. The skills required to launch such attacks are not difficult to buy, borrow, or develop. BTRP is the largest biological nonproliferation program in the world. The United States and the broader global community can benefit from an expansion of BTRP to protect their assets. The expansion should be on a sufficient scale to significantly reduce the threat of bioterrorism. However, a geographical expansion of BTRP should be undertaken within an interagency context—both to ensure complementary approaches of differ- ent U.S. government agencies and to facilitate BTRP’s drawing on appropriate expertise across the government. At present, the secretary of state must concur with any expansion of BTRP activities; and this requirement helps ensure that BTRP activities will be launched within a government-wide context. At the same time, the agencies should recognize the importance of BTRP’s assets and encourage BTRP to expand its activities. Also of importance is recognition by BTRP, and indeed throughout the U.S. government, that there is considerable overlap between strengthening health and agriculture disease surveillance systems that are already in various stages of development in developing countries and enhancing biosecurity capa- bilities of the countries. (See Chapter 5 for additional discussion of interagency coordination.) A reasonable target is for BTRP to begin biological engagement in at least 10 countries outside the FSU during the next 5 years. Ten countries is a rea- sonable number given the seriousness of the global threat, the complexities of effective engagement, and the limited resources that are likely to be available to BTRP. This is a more ambitious objective than current DOD plans that call for new engagements with only three countries within or outside the FSU dur- ing the next 5 years. Engagement in three countries is an inadequate response to a widespread global threat. DOD estimates that the total cost of engaging three countries would be about $180 million and has preliminarily earmarked such funding in its long-term planning process. The basis for such an estimate depends on a multiplicity of factors related to the levels of engagement, which

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 SECURITY CONTEXT FOR GEOGRAPHICAL EXPANSION OF BTRP in turn depend on the countries of interest. Nevertheless, the estimate provides one perspective of the costs of expanding into the developing countries. The levels of engagement should be appropriate to country-specific threats, to local capabilities for effective use of enhanced capabilities, and to interests of counterpart countries in such engagement. At the same time, BTRP should not divert resources that BTRP needs to complete activities in the FSU for its new efforts. This financial challenge requires careful analyses of where and how BTRP can achieve the greatest impact in risk reduction within the context of commitments of both local and international commitments to biosecurity. Recommendation 1-2: BTRP’s initial engagement activities in any develop- ing country outside the FSU should be planned to last for up to 5 years, with consideration given to extending engagement activities for another 5 years depending on initial successes in reducing biological threats and the future importance of continued engagement. To implement this recommendation in a responsible manner, BTRP will have to launch programs promptly and implement them without the delays that too often have characterized activities in some countries of the FSU largely because of DOD’s reluctance, despite the potential threats, to make BTRP activities a priority. (See Table 1-3 for the long timelines in the countries of the FSU.) Also, BTRP needs to emphasize the importance of sustainable biosecurity programs and the necessity for host governments to promptly attract multiple international partners to the long-term task of enhancing local capabilities. A similar challenge has been encountered within the President’s Emergency Program for AIDS Relief, and BTRP should review relevant steps taken in this program. There are too many countries with severe biosecurity vulnerabilities for BTRP to remain in any country for a long period in order to address sec- TABLE 1-3 Duration of BTRP Engagement in Countries of the FSU Country Duration of Engagement Armenia 2008-? (end date not yet set) Azerbaijan 2005-2013 Georgia 2002-2015 Kazakhstan 2003-2016 Russia 1997-2009 Ukraine 2005-2013 Uzbekistan 2003-2016 SOURCE: Biological Threat Reduction Program, October 2008.

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 COUNTERING BIOLOGICAL THREATS ondary problems. However, within a constrained timetable BTRP can not only complete important upgrade activities but can also help jump-start additional activities and be a catalyst for action for complementary and sustained activities by others, and particularly by the host countries themselves. The remainder of this report addresses how enhanced biosecurity capabili- ties in developing countries can help prevent groups or individuals with hostile intentions from obtaining and dispersing harmful biological agents. It describes conditions in a variety of countries and provides a menu of activities that could be undertaken by BTRP. It also presents lessons learned by several organiza- tions that are engaged in preventing bioterrorism. The report will show that BTRP is in a good position to help counteract nefarious schemes of individuals who live in or have access to developing coun- tries and who are determined to wreak havoc with infectious diseases, whether for ideological or personal motives. At the same time, BTRP must ensure that its activities do not inadvertently contribute to bioterrorism concerns. Training specialists, collecting pathogens in centralized facilities with uncertain long-term security, and transporting pathogens by insecure means all have the potential to offer new targets for terrorists.