Countering Biological Threats: Challenges for the Department of Defense's Nonproliferation Program Beyond the Former Soviet Union (2009)

Below is the uncorrected machine-read text of this chapter, intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text of each book. Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.

Summary The National Defense Authorization Act of 2008 called for a study by the National Academy of Sciences (NAS) on the prevention of proliferation of biological weapons. The study was to consider several issues concerning U.S. cooperation in this field with developing countries other than states of the former Soviet Union (FSU) within the framework of the Cooperative Threat Reduction (CTR) Program that is administered by the Department of Defense (DOD). Specifically, Congress requested that the study (a) assess the capacity of developing countries to control dual-use technologies, (b) assess coopera- tive nonproliferation approaches used in the FSU that could be used in other countries, (c) review other international programs that may contribute to non- proliferation, and (d) recommend steps for integrating DOD’s nonproliferation activities with other relevant U.S. government programs outside the FSU.  DOD has supported biological nonproliferation activities in seven coun- tries of the FSU during the past 12 years at a cost of about $800 million within the framework of the CTR Program. These activities, referred to as the Bio- logical 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  For the purposes of this summary as well as the full report, biological weapons include any biological pathogens and associated toxins that could be deliberately misused to cause significant harm to humans or agricultural resources. Biosecurity encompasses all direct and indirect mea- sures that contribute significantly to (a) preventing inappropriate persons from gaining access to materials, equipment, or technology that could be used in producing biological weapons; or (b) detecting, characterizing, or responding to outbreaks of diseases that involve biological pathogens. It encompasses, but is much broader than, biosafety. Biosafety covers the application of knowledge, techniques, and equipment to prevent personnel, laboratory, or environmental exposure to po- tentially infectious agents or biohazards. “Developing countries” include more than 130 low- and middle-income countries outside the FSU, as defined by the World Bank.  

 COUNTERING BIOLOGICAL THREATS Threat Agent Detection and Response (TADR) 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 devel- oping countries beyond the FSU. In this regard, DOD has begun considering efforts directed to Afghanistan, Pakistan, and the Democratic Republic of the Congo, although no commitments to these countries have been made. This summary sets forth principal findings and recommendations of the study using primarily information available as of November 30, 2008. The importance of strengthening existing health and agriculture disease surveillance and response capabilities of partner governments, which overlap in many ways with systems for preventing and reducing the impact of bioterrorism incidents, is a recurring theme of this summary and the full report. Poor countries cannot afford a separate surveillance system for pathogens of bioterrorism concern and a surveillance system for other disease agents. Also, several U.S. government departments and agencies have relevant international activities and capabilities, and the importance of BTRP operating within an interagency framework is an essential aspect of much of the discussion. The full report elaborates on the findings and recommendations and presents additional observations. SECURITY CONTEXT In low-income countries and many areas of middle-income countries, the primary security issue for hundreds of millions of people is survival—enough food and water, adequate shelter, and tolerable levels of diseases. Unemploy- ment and underemployment are high in many areas of the world. Sometimes impoverished populations also must cope with insurgents, terrorists, and gangsters—and even full-scale wars—that force them to move to unfamiliar sur- roundings. Neither the governments nor the populations in these circumstances can give priority to combating bioterrorism, which until now has not become a significant threat in their countries. However, they do know that naturally occurring diseases cause suffering and deaths and can have debilitating impacts on society (see Box S-1). Meanwhile, many international specialists have highlighted the urgency of addressing bioterrorism on a broad scale (see Box S-2). An attack with roots in a developing country could claim victims within or outside the country. It could be a serious setback for positive aspects of the country’s political and economic agendas by diverting resources to yet another impediment to development. 

SUMMARY  BOX S-1 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. More broadly, the worldwide psychological impact of a major bioterrorism incident would be traumatic. The infrastructure required to support a bioterrorism attack is relatively small, but the infrastructure for countering an attack is complex. A variety of factors are important in detecting and responding both to naturally occurring and to malevolently instigated outbreaks of diseases. Some pathogens found in nature, as well as other genetically engineered disease agents, could be dispersed by terrorist organizations or by individuals motivated by personal animosity or financial considerations. Major responsibilities to counter biological threats, whatever the source, usually rest with the same scientists and practitioners. Therefore, the strategies to combat both naturally occurring and deliberately released pathogens should be well integrated. Some aspects of early warning systems for these two types of threats may differ (for example, intelligence systems to identify bioterrorism plots and epidemiology systems designed to identify outbreaks of nature). But most aspects of effective human health and agricultural surveillance and response systems, including detection, diagnosis, and therapy, are important in countering infectious disease threats in general. In efforts to reduce the proliferation of biological weapons, the interna- tional community has developed many important international treaties, regula- tions, agreements, and codes of conduct that provide a framework for actions on a global basis. The development and implementation of appropriate laws, regulations, and guidelines at the national level are vital. For example, the International Health Regulations, while still in the early stage of implementa- tion, not only provide a legal framework but also define public health events of international concern. National actions should also emphasize the development 

 COUNTERING BIOLOGICAL THREATS BOX S-2 Threat of Biological 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. of appropriate physical and personnel infrastructures to prevent bioterrorism in accordance with international obligations. This task is difficult in resource- poor developing countries. BTRP can help—in some countries as the lead U.S. program and often as support to other agencies that would lead U.S. or broader international efforts. 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. BTRP is the largest biological non- proliferation program in the world. The United States and the broader global community can benefit from a geographical expansion of BTRP within an appropriate U.S. interagency framework on a sufficient scale to significantly reduce the threat of bioterrorism outside the FSU. A reasonable target is for BTRP to begin biosecurity engagement, as the lead or as a supporting U.S. government program, in at least 10 countries outside the FSU during the next 5 years. This is a reasonable number given the magnitude of the global threat, the complexities of effective engagement, and the resources likely to be available to BTRP. The type of engagement should depend on local threats and vulnerabili- ties, local capabilities to effectively implement enhanced biosecurity measures, and those aspects of biosecurity engagement that are strongly embraced by the countries of interest. At the same time, BTRP should not divert its available resources that are needed for completion of important biosecurity enhance- ments in the FSU to support new efforts in additional countries. 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 

SUMMARY  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. Thus, from the outset, BTRP will be required to launch programs without the years of delay that too often have char- acterized the initiation and conduct of biosecurity activities in the FSU. Also, BTRP will need to emphasize the development of sustainable programs and the necessity for host governments to attract multiple international partners to the long-term task of enhancing local capabilities. At the same time, too many countries have severe biosecurity vulnerabilities for BTRP to use its limited resources to fix secondary problems that pose minor risks. But BTRP can carry out priority biosecurity upgrades and jump-start others on a broad basis while being a catalyst for complementary actions by other parties, and particularly actions by local organizations in the countries of interest. CAPACITIES OF DEVELOPING COUNTRIES TO COUNTER BIOLOGICAL THREATS Biology-related capabilities in each of the more than 130 developing coun- tries are different. However, few developing countries have adequate capabilities to counter biological threats on a broad basis. In some countries, particularly in Africa, capabilities to cope with infectious diseases are severely limited. With international support, most developing countries have for decades been upgrading their national systems for reducing disease burdens and for preventing disease agents from limiting agricultural production or contaminat- ing exported or imported food products and commodities. But progress is slow and uneven. Capabilities to address bioterrorism depend on these same systems while also requiring additional security arrangements. Some challenges such as deficiencies in the number of qualified scientific personnel are present throughout developing countries, although they differ in scope and severity. For example, Pakistan, despite an enormous brain drain, has a significant cadre of good scientists, largely with Western training. In Indone- sia, the situation is bleaker, with only a limited number of specialists, many of whom were trained in Australia. Still of greater concern is the situation in the Philippines, where the capabilities of the higher education system lag behind appropriate training opportunities in other countries of the region. Similarly, policies and financial resources that determine the directions of biological activities vary significantly among countries. For example, Brazil is in a class by itself in pressing forward with biotechnology in Latin America. Sin- gapore and Malaysia are becoming biomedical hubs in Southeast Asia. Turkey and Egypt are well ahead of many other nearby countries in the life sciences. South Africa stands out as a biotechnology leader in Africa. Also, biosecurity conditions vary within countries. For example, in Thai- land, several modern biotechnology centers stand apart from many more lim- 

 COUNTERING BIOLOGICAL THREATS ited facilities in the country. In Pakistan, the level of effective security at the country’s dozens of bioscience and biotechnology facilities varies dramatically. The list of vulnerabilities to biological threats in developing countries is long. Many countries have good biosafety regulations, but enforcement is generally weak. Governments may have little capability to diagnose and confirm suspected human or animal outbreaks. Many laboratories are poorly equipped, and some are barely functioning. Pathogen collections are often scattered throughout the country but are poorly documented, maintained, and secured. Reliability of electricity, communications, and basic water and sanita- tion networks is questionable at best. The number of trained technicians and scientists is inadequate. From well-qualified security guards to experienced laboratory managers to competent research scientists to responsible biotechnol- ogy entrepreneurs, there are opportunities for BTRP to address shortfalls and thereby contribute to the betterment of science, reduction of threats of bioter- rorism, and improvement of public health (see, for example, Box S-3). Recommendation 2-1: BTRP should continue to emphasize to partner gov- ernments the importance of their strengthening on a broad basis the infra- structures necessary to address human, animal, and plant diseases and the underlying scientific capabilities of the countries as essential foundations for addressing threats of bioterrorism. Biology-related activities depend on many aspects of a nation’s physical infrastructures, its human resources base, and its policy commitments to reducing disease burdens. In particular, health and agriculture disease surveillance systems and associated research facilities are important. The security services play significant roles and require their own types of support. Transportation networks and communication capabilities are essential. TRANSFERABILITY OF APPROACHES TO BIOLOGICAL THREAT REDUCTION ADOPTED IN THE FSU BTRP capabilities and approaches have been well tested in the FSU, and many can be readily adjusted for circumstances in other countries. Most impor- tantly, BTRP now realizes that partnerships rather than foreign assistance rela- tionships with counterparts are essential in obtaining necessary buy-in for sustainable cooperative activities. These partnerships should begin from the outset of engagement and be reflected in the initial strategies and plans for BTRP-supported activities. Then BTRP will have opportunities to draw on its many training, engineering, biosafety, and other well-honed approaches. Cooperative research has not been a strong aspect of BTRP, but other U.S. government organizations and several universities are assisting BTRP. Thus, BTRP has focused local attention on important research challenges such as investigations of brucellosis and plague, which are readily recognized by coun- 

SUMMARY  BOX S-3 Systemic Weaknesses in Addressing the Risk of Disease Threats Most developing countries have limited ability to • monitor disease patterns, • identify new organisms, • investigate outbreaks and routes of transmission, • stockpile and mobilize commodities, • rapidly respond with trained staff, • educate the public on prevention and care seeking, • regulate unsafe animal rearing, transport, and selling, and • coordinate routine and emergency operations among health, animal, and other sectors. SOURCE: USAID briefing to the committee, November 3, 2008. terparts as local threat agents. Together they have used collaborative research as a basis for developing good rapport not only with scientists but also with local officials. BTRP has encountered some administrative difficulties in delivering prod- ucts. At times, the chain of command for implementing projects from DOD through DTRA, through contractors, and through subcontractors to individual implementers of projects has been inefficient. While BTRP has made consider- able progress in reconciling DOD procedural requirements with conditions on the ground, simplification of procedures is needed. As to impacts, BTRP is now developing an overdue system of appropriate metrics, but expanded efforts in this regard are still needed. The following approaches are essential to address the above concerns. Recommendation 3-1: As BTRP moves beyond the FSU, the theme of part- nerships with counterpart organizations in host countries should be a guiding principle. The governments of some developing countries associate foreign funds with foreign aid. But if they can be convinced through both words and actions that BTRP wants them as true partners, the path to success of BTRP will be wide and the likelihood of sustainability will be increased. Recommendation 3-2: BTRP should develop in cooperation with each partner government a Strategic Plan that describes the security situation and particu- larly vulnerabilities relevant to biological assets in the country, disease burdens 

 COUNTERING BIOLOGICAL THREATS and trends, local capabilities to detect and respond to outbreaks, and plans for cooperative threat reduction activities within the context of national plans and capabilities of both countries. BTRP’s experience in developing country-spe- cific “Science Plans” in the FSU is a starting point. The Strategic Plan should be developed jointly with host-country partners and within the framework of the U.S. government’s evolving overall strategy for biosecurity engagement in the country of interest. The plan should of course take into account the near-term security-related developments that are relevant to effective use of the country’s biological capabilities. Emphasis should also be placed on long-term goals that require sustained efforts, including efforts after BTRP’s departure from the country. The plan should address containment of pathogen collections, assessment of disease burdens and trends, development of local capabilities to detect and respond to disease outbreaks, enhancement of research laboratories and joint research opportunities, allocation of financial resources available from local and international sources, engagement of organizations that will sustain BTRP-supported initiatives, and BTRP’s exit strategy. The strategic plans should be regularly reviewed, as individual plans and as a set of plans with common goals. Recommendation 3-5: BTRP should support cooperative biological research in countries where it engages, even if local research capabilities are limited. Cooperative research involving local and U.S. scientists over an extended period of time can enhance transparency and build trust as to BTRP’s overall inten- tions while upgrading local capacity to investigate problems of local concern. Regional networks of BTRP-supported investigators working on similar topics in different countries may in time offer important approaches to sustainable international research relationships. Recommendation 3-7: DOD should streamline its chain of command for implementing BTRP and simplify the operational process within DOD to enhance efficiency, reduce misunderstandings, and increase transparency con- cerning U.S. intentions toward the host governments. Given likely sensitivities to DOD’s involvement in programs in some developing countries, misunder- standings and false expectations should be avoided to the fullest extent pos- sible. While DOD has well-established management procedures for drawing on contractors as implementers of programs, the special procedures developed for BTRP have been unnecessarily complex and too Washington-centric. DOD should, of course, ensure that policy requirements are satisfied. Nevertheless, DOD needs to reduce the time to approve plans and the delays in implemen- tation of projects while ensuring that U.S. government officials, rather than contractors, are in the forefront in engagement with host governments. Recommendation 3-9: BTRP should continue to develop improved metrics 

SUMMARY  that will help guide evaluations of the impacts of BTRP and provide infor- mation for setting priorities for activities designed to reduce proliferation of biological weapons as well as related risks from naturally occurring contagious disease agents. BTRP should continue to track the number of facility upgrades, consolidated pathogen collections, and research projects completed; number of trainees; quantity and quality of scientific publications; sustained linkages between U.S. and partner institutions; and other identifiable results attributable in part to BTRP. But additional indicators that reflect impacts in enhancing U.S. security interests should be developed and pursued (for example, time to recognize and respond to an outbreak, improved ability to characterize infec- tious disease agents, and expanded data sharing). Indicators used by other U.S. agencies and by international organizations should, of course, be considered for possible use by BTRP. To gain a better appreciation of trends reflected in indicators that are difficult to quantify, BTRP should support qualified local specialists who can undertake parallel efforts to measure the impacts of BTRP activities in their own countries. Recommendation 3-10: BTRP should take into account possible local con- cerns about a large presence of DOD activities in the countries where it engages. Joint projects with other organizations playing important roles and an emphasis on responding to local initiatives will be helpful in this regard. Whenever possible, BTRP should partner with civilian organizations that have strong health and agriculture reputations in the developing countries, such as the World Health Organization, the Food and Agriculture Organization, the World Bank, the regional development banks, the U.S. Agency for International Development, and the Centers for Disease Control and Prevention (CDC). RELEVANT ACTIVITIES OF OTHER ORGANIZATIONS IN DEVELOPING COUNTRIES Many U.S. government departments and agencies, agencies of other gov- ernments, international organizations, international companies, and nongov- ernmental organizations are involved in activities related to biological threat reduction. DOD alone has more than 15 entities with relevant programs. At least six other U.S. departments and agencies have responsibility for significant international activities that can contribute to countering biological threats. BTRP can benefit from drawing on the capabilities, experiences, and activities of many of these organizations (see, for example, Box S-4). BTRP currently interacts with about 35 organizations that have relevant program interests in the FSU. In developing countries beyond the FSU, the array of organizations with relevant programs will be much larger, with a stron- ger emphasis on international development and with less experience specific to biosecurity. Sharing experiences among organizations and identifying ways to 

10 COUNTERING BIOLOGICAL THREATS BOX S-4 Lessons Learned by CDC in Developing Countries • Ensure the program is consistent with local priorities. • Avoid taking personnel from other important local programs. • Ensure local buy-in of activity. • Ensure program compatibility and integration with existing local activities, structures, methods, and equipment. • Avoid high-technology solutions for low-technology environments and ensure availability of replacement equipment and parts. • Minimize reliance on foreign experts. • Design a system that is affordable and can be maintained locally. • Design a system that is capable of coping with unpredictable changes in the operating environment. • Have a monitoring and evaluation component. • Resolve implementation issues early. SOURCE: CDC expert, presentation to the committee, July 2008. develop complementary activities is increasingly important as the U.S. govern- ment, including DOD, expands international biosecurity activities. As BTRP launches programs beyond the FSU, coordination of activities in the field will be particularly important. Recommendation 4-8: BTRP should station regional or country representa- tives in areas where new activities are initiated with responsibility for keep- ing abreast of related activities and for promoting synergies among BTRP activities and related interests of other organizations. Only through an on-the- ground presence will BTRP be able to stay abreast of the many activities and interests of organizations from around the globe that have programs that should interface with BTRP activities. In some cases, a BTRP representative might be based at an overseas DOD research laboratory. In other circumstances, it may be more appropriate for the representative to be stationed at the U.S. embassy in the country of interest or at an embassy in a region of interest. POLICY AND PROGRAM COORDINATION AND INTEGRATION Integration of biological nonproliferation activities supported by the U.S. government has for several years been on the agenda of the National Security Council (NSC), with the Department of State playing a leadership role in this 

SUMMARY 11 regard. The NSC and the Homeland Security Council lead a Policy Coordina- tion Committee (PCC) for Biodefense with a panel on international bioengage- ment that brings together officials responsible for relevant aspects of homeland security and nonproliferation and some aspects of international development. Among the activities of the PCC is the development of government-wide frame- works for addressing biological threats in specific countries. In the field, coordination is a critical component of integration, as noted above. Coordination is often dependent on the interests of the local U.S. ambas- sador. BTRP will have the challenge of ensuring that its activities are appropri- ately included in the embassy’s Mission Strategic Plan and that U.S. government officials stationed abroad take advantage of BTRP’s activities and capabilities. BTRP field representatives should be helpful in this regard. An important step in setting the tone and framework for interagency coor- dination is to ensure that DOD is closely linked to the key U.S. government departments with internationally recognized expertise in relevant areas. The following recommendation is directed to this end. Recommendation 5-3: The authors of the National Defense Authorization Act should include in the act a provision calling on DOD to utilize as appropriate the capabilities of other U.S. government departments and agencies, particu- larly the Department of Health and Human Services (HHS) and the Depart- ment of Agriculture (USDA), to assist in the development and implementation of BTRP activities. To this end, the act should recognize the importance of transfers of BTRP’s resources to these organizations as necessary and should call for BTRP to provide Congress within its annual reports information on the extent and effectiveness of such transfers. While BTRP has engaged other departments and agencies in its activities for many years, their participation is often ad hoc with uncertain duration. A legislative mandate for such involve- ment should help resolve uncertainties and enable BTRP to benefit more fully from international recognition of the scientific wherewithal of other participat- ing departments. Of course, BTRP-supported activities should to the extent possible be integrated with activities supported financially by the other depart- ments themselves. At the same time, BTRP should recognize that in some cases other agencies are better equipped to adequately address important biosecurity issues alone and should therefore not become involved in those issues. THE WAY AHEAD In short, the risk of bioterrorism is too great for BTRP not to be among the leading organizations internationally in addressing the threat outside the FSU. BTRP, in continuing consultation with partner governments, should emphasize a systems approach to address a range of pathogens—particularly those of day- to-day concern—that strengthens health and agricultural surveillance capabili- 

12 COUNTERING BIOLOGICAL THREATS ties, pathogen security, and research activities on a broad basis. BTRP needs to expand cooperation with U.S. and foreign government and nongovernment organizations with overlapping interests. DOD’s planning and operational pro- cedures should be streamlined. Sustainability must be at the top of its priority concerns. Strategic plans and more meaningful metrics developed with partner governments that respond to the overall interests of the governments need to guide the effort. DOD should consider this report as more than a series of disconnected recommendations from which it can simply choose. Each recommendation addresses an important issue that needs to be considered in an integrated man- ner if BTRP is to find success in its effort to reduce the risks associated with the threat of bioterrorism. This report provides an overall framework and a starting point to finding the best approaches within the framework. As the first step in developing an action plan, DOD should promptly identify initial target countries outside the FSU. The selection criteria for target countries are numerous but should include (1) the likelihood of significant risk reduction and (2) the near-term likelihood that successes can be sustained over the long term. In some cases, BTRP may be the appropriate lead organization for the U.S. effort, while in other cases, BTRP may play a supporting role in the national effort. Of course, BTRP must be welcomed in the countries of interest. Whether reconstructing facilities, upgrading surveillance or research capa- bilities, or providing training and related services, BTRP’s activities should be based on a clear vision of how they will improve biosecurity in the next 5 years. In some cases, a broad countrywide approach may be necessary to reduce vul- nerabilities significantly. In other cases, a relatively minor contribution by BTRP may make a substantial difference in the biosecurity landscape of the country. In conclusion, BTRP can make a significant contribution to raising aware- ness of the governments, specialists, and public in developing countries of the importance of a range of policies and programs for addressing biological threats. An effective mechanism for raising awareness is the launching of cooperative projects that demonstrate the impacts of practical approaches to addressing vulnerabilities while also enhancing economic development opportunities. The community of specialists in the field of biosecurity is small, and information about BTRP cooperative projects will spread quickly. Discrete, time-limited, and action-oriented projects rather than vague promises and endless discussions should continue to characterize BTRP’s approaches. In time, BTRP activities, as part of an integrated U.S. government approach, should increase respect for U.S. humanitarian-oriented objectives while reducing biosecurity threats.