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

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3 Applicability of Biological Threat Reduction Approaches in the Former Soviet Union to Other Developing Countries Since 1998, the Biological Threat Reduction Program (BTRP) has devel- oped into a broadly based international program operating in seven countries of the former Soviet Union (FSU). As previously discussed, its overall objective is to reduce the likelihood of proliferation of materials, equipment, technologies, and expertise that could be used in the development or construction of biologi- cal weapons. This objective includes reducing the risk of bioterrorism. In 2008, BTRP received funding to explore the expansion of its activities to developing countries outside the FSU. This report, and particularly this chapter, is directed to such an expansion. In the FSU, BTRP has used a wide range of approaches spanning the secu- rity, scientific, public health, and agriculture fields, which have been designed to help prevent the proliferation of biological weapons. The budget for BTRP’s activities through Fiscal Year (FY) 2009 has been almost $800 million. The budget for FY 2009 is about $185 million. Ten million dollars from FY 2008 funds and a comparable amount from FY 2009 funds are to be directed to activities in developing countries beyond the FSU. Budget projections of the Department of Defense (DOD) show growth of BTRP to about $250 million annually by FY 2014. Expecting gradual expansion of activities beyond the FSU, DOD has estimated that about $180 million of the total BTRP budget through 2014 will be used to expand the program to other countries, primarily outside the FSU. Thus, according to these projections, the major geographic focus of BTRP will continue to be selected states of the FSU for the foreseeable future. In FY 2008, BTRP’s funds were devoted primarily to three categories of activities: (1) biosecurity and biosafety, (2) threat agent detection and response (TADR), and (3) cooperative biological research (CBR). The first and second categories included many construction projects to establish and renovate diag- 59 

60 COUNTERING BIOLOGICAL THREATS nostic facilities, a variety of training programs, and efforts to enhance laboratory and field investigation capabilities in order to improve surveillance capabilities. These activities will probably continue to command most of the available funds for the foreseeable future. CBR funds have supported both researchers in the FSU and U.S. collaborators. The funds have also been used to purchase equip- ment when needed by FSU participants for specific research projects and to upgrade laboratories in the FSU. Until FY 2008, funds were also devoted to activities in a previously exist- ing category of dismantlement and conversion of facilities. These efforts had included redirection of three facilities in the FSU that produced pathogens and other materials that could be used for biological warfare activities. BTRP has completed its activities in this category. The future of BTRP within the FSU was considered in the October 2007 report. This report draws on the October 2007 report in discussing future BTRP activities while recognizing the many differences between operating in the FSU and in other regions. THE NEED FOR A SUSTAINED COMMITMENT TO NONPROLIFERATION As discussed in Chapter 1, the likelihood of bioterrorism attacks in devel- oping countries outside the FSU is growing in unpredictable directions. Coun- tering bioterrorism is highly complicated, requiring a wide-ranging defensive infrastructure. Many scenarios could be carried out exploiting the vulnerabili- ties found in almost every developing country. As emphasized in Chapter 1, tens of millions of dollars will be required for BTRP to have a significant impact on limiting proliferation of dangerous biological assets within, into, or out of even a handful of developing countries beyond the FSU. The problem is widespread, and activities to reduce some of the most important vulnerabilities are expensive. Few developing countries have major resources of their own to devote to countering the potential of bioterrorism. As will be discussed in Chapter 4, substantial international development assistance resources are being devoted to strengthening the capabilities of developing countries to control health and agriculture diseases. Of course, such activities will help in the prevention of and response to threats of bioter- rorism. But in the FSU, BTRP—together with programs of several other U.S.  National Research Council Committee on Prevention of Proliferation of Biological Weapons. 2007. The Biological Threat Reduction Program of the Department of Defense: From Foreign As- sistance to Sustainable Partnerships. Washington, D.C.: The National Academies Press. Available online at www.nap.edu/catalog.php?record_id=12005. In the current report this report is referred to as the “October 2007 report.” 

APPLICABLITY OF BIOLOGICAL THREAT REDUCTION APPROACHES 61 departments—has more directly addressed vulnerabilities of bioterrorism con- cern. Such a focus should be one of the essential aspects of nonproliferation approaches in other countries as well. The U.S. commitment to biological nonproliferation activities focused on the developing countries outside the FSU during the next 5 years will be determined in significant measure by the size of BTRP’s budgetary commitment and the success of its activities. Given the magnitude of the threat, BTRP’s com- mitment for activities beyond the FSU should reach a robust level of preven- tion and response. At the same time, the planning and implementation of such activities should take into account issues raised throughout this report. BTRP has had considerable success in working with the governments of the states of the FSU to upgrade many aspects of biosecurity. Still, with the possible exception of Russia, none of the countries is well prepared to sustain on its own successful approaches that have been financed by BTRP. Therefore, adopting approaches to ensure sustainability of activities initiated with the support of BTRP should be a high priority both within the FSU and in other countries as well. THE UNIQUE ENVIRONMENT WITHIN THE FSU The predecessor program to BTRP, the Biological Weapons Prolifera- tion Prevention Program, was initiated by DOD in 1998 at a time of height- ened international concern over the possibility that biological weapons-related activities would be undertaken in the FSU. It was believed that such illegitimate activities could be undertaken by the Russian government or by individuals previously involved in the Soviet weapons program who might develop con- nections to criminal or terrorist organizations. The legacy of a robust Soviet biological weapons program loomed large, and the U.S. government considered that greater transparency at previously closed biological facilities in the FSU was a national security imperative. At the same time, the states of the FSU were in a downward economic spiral. This decline raised additional international concerns over the possibility that impoverished scientists would try to earn money through the unauthorized sale of biological assets that together with their expertise could lead to dangerous consequences. DOD’s initial efforts quickly focused on containment of those assets of greatest immediate concern to U.S. biosecurity specialists. Prompt attention was given to consolidating and strengthening security of pathogen collections. Redirection to peaceful purposes of research activities at former defense-related facilities and of individual weapon scientists was a priority. Also, monitoring the use of the results of research carried out in the FSU that could be deliberately or inadvertently diverted to inappropriate uses rather than internationally accept- able applications became a related priority, although this task was difficult to 

62 COUNTERING BIOLOGICAL THREATS carry out. Each type of redirection activity was to promote transparency as an important contribution to prevention of proliferation of biological weapons. The facilities of primary concern to the U.S. government included biologi- cal research and production centers that had histories of handling significant quantities of dangerous pathogens, which had been of interest to Soviet military authorities. These facilities were accustomed to extensive security procedures, including high fences and close screening of personnel. However, with the eco- nomic decline, security budgets were being reduced, and atrophy of effective security measures was apparent even within some of the most heavily guarded facilities. In short, the need for urgent action to prevent biological pathogens from falling into the hands of unauthorized personnel was widely recognized; and BTRP focused its efforts on obvious vulnerabilities, particularly at facilities where pathogens had been produced or handled under military contracts. At the same time, the U.S. government recognized new opportunities to engage highly talented former defense-oriented scientists in the FSU in research of considerable interest to the United States—research for biodefense purposes and for applications in improving public health, combating agricultural dis- eases, and advancing fundamental science. BTRP became the largest U.S. gov- ernment program that supported such researchers in the FSU, where the pools of well-trained and experienced specialists with previous orientations toward defense activities were large, although their equipment was rapidly aging, facili- ties needed improved maintenance, and salaries had dipped to low levels. Also, the intake of young talent to pursue civilian-oriented activities at research and production facilities had nearly halted because of the severe budget decline. In short, many members of a large pool of underemployed scientists were search- ing for opportunities to increase their incomes with declining personal concern over how their talents would be used. No developing country outside the FSU has found itself in a comparable position involving (1) previous governmental leadership in developing bio- logical weapons, (2) large and highly skilled pools of specialists with dual-use capabilities, and (3) a sudden shift from a stable, centrally planned economy to economic chaos as the transformation to market economies began. While South Africa established and then dismantled a biological weapons capability and may have residual capabilities of concern, it is an exception among developing countries. When BTRP began its activities and even today, the conditions in the FSU were and continue to be different from the environments encountered in developing countries outside the FSU. Tables 3-1 and 3-2 present striking differences in the characteristics of developing countries within and outside the FSU that are relevant to biosecurity. For example, the differences in literacy rates and availability of trained physicians are particularly great.  Purkitt, H., and S. Burgess. 2005. South Africa’s Weapons of Mass Destruction. Bloomington, IN: Indiana University Press. 

TABLE  3-1 Biosecurity-related Development Characteristics of Selected FSU Countries Armenia Azerbaijan Georgia Kazakhstan Ukraine Uzbekistan Population in millions, 2007a 3.001 8.571 4.396 15.481 46.383 26.868 Gross national income per capita (U.S. $), 2,640 2,550 2,120 5,060 2,550 730 2007a Annual gross domestic product (GDP) 14 19 12 8 7 10 growth (percent), 2007a Life expectancy at birth, 2006b 69 64 70 64 67 68 Adult literacy rate (percent of population n/a 99.38 99.00 99.62 99.69 99.30 age 15+), 2007a Total expenditure on health as percent of 5.40 3.90 8.60 3.90 7.00 5.00 GDP, 2005c Improved water source (percent of 98 78 99 96 97 88 population with access), 2006b Improved sanitation facilities (percent of 91 80 93 97 93 96 urban population with access), 2006b Physicians per 10,000 population, 2000- 37 36 47 39 31 27 2006b Persons employed in research and n/a 10,195 11,997 11,910 85,211 n/a development, 2006c Gross tertiary enrollment rate, 2006c,d n/a 14.81 38.20 51.18 72.78 9.80 Computers per 1,000 people, 2005c n/a 20 50 n/a 50 30 Internet users per 1,000 people, 2007a n/a 120 80 120 220 40 Exports of goods and services as percent of n/a 72.50 45.30 50.60 48.20 38.40 GDP, 2006b aThe World Bank Group World Development Indicators; www.worldbank.org. Accessed January 12, 2009. bWorld Health Statistics 2008; www.who.int/whosis/whostat/EN_WHS08_Full.pdf. Accessed January 12, 2009. cThe World Bank Knowledge for Development (K4D) Custom Scorecard; info.worldbank.org/etools/kam2/KAM_page3.asp?default=1. Accessed January 12, 2009. dThe ratio of total enrollment, regardless of age, to the population of the age group that officially corresponds to the level of education indicated. 63 

TABLE 3-2  Biosecurity-related Development Characteristics of Selected Countries Outside the FSU 64 Democratic Republic of South Congo Malaysia Mexico Morocco Pakistan Africa Population in millions, 2007a 62.399 26.550 105.281 30.861 162.389 47.588 Gross national income per capita (U.S. $), 140 6,540 8,340 2,250 870 5,760 2007a Annual gross domestic product growth 6 6 3 2 6 5 (percent), 2007a Life expectancy at birth, 2006b 47 72 74 72 63 51 Adult literacy rate (percent of population n/a 91.90 92.43 55.58 54.89 88.00 age 15+), 2007a Total expenditure on health as percentage 4.20 4.20 6.40 5.30 2.10 8.70 of GDP, 2005c Improved water source (percent of 46 99 95 83 90 93 population with access), 2006b Improved sanitation facilities (percent of 31 94 81 72 58 59 urban population with access), 2006b Physicians per 10,000 population, 2000- 1 7 20 5 8 8 2006b Persons employed in research and n/a 12,669 33,484 n/a 12,689 17,915 development, 2006c Gross tertiary enrollment rate, 2006c,d n/a 28.58 26.08 11.83 4.52 15.41 Computers per 1,000 people, 2005c n/a 220 140 20 10 80 Internet users per 1,000 people, 2007a n/a 560 220 240 110 80 Exports of goods and services as percent of n/a 117.10 31.90 37.80 15.50 29.10 GDP, 2006b aTheWorld Bank Group World Development Indicators; www.worldbank.org. Accessed January 12, 2009. bWorldHealth Statistics 2008; www.who.int/whosis/whostat/EN_WHS08_Full.pdf. Accessed January 12, 2009. cThe World Bank Knowledge for Development (K4D) Custom Scorecard; info.worldbank.org/etools/kam2/KAM_page3.asp?default=1. Accessed January 12, 2009. dThe ratio of total enrollment, regardless of age, to the population of the age group that officially corresponds to the level of education indicated. 

APPLICABLITY OF BIOLOGICAL THREAT REDUCTION APPROACHES 65 At the same time, there are common characteristics when comparing opportunities for BTRP to achieve its objectives in the FSU with opportunities in other developing countries. Identified below are commonalities that deserve careful attention in this regard. In some cases, minor adjustments of BTRP approaches used in the FSU might be appropriate for deployment outside the FSU. In other cases, major modifications of these approaches are in order. In still other cases, BTRP’s approaches may not be appropriate; and in some instances, BTRP may not be welcomed by other governments that are con- cerned about an expanded U.S. military presence—in such situations, BTRP probably should remain on the sidelines for the near future. In any event, the achievements of BTRP to date provide a starting point for considering transportability of BTRP approaches developed in the FSU to other countries. The overall outcome of BTRP’s activities in any country should be a reduction in the risk from bioterrorism. Two important aspects of risk reduction are (1) a reduction in the likelihood that pathogens that are present in the country or introduced into the country will be diverted for nefarious pur- poses within the country or elsewhere, and (2) an enhanced capacity to detect and characterize outbreaks causing excessive levels of morbidity and mortal- ity. As discussed in Chapter 2, to achieve these outcomes, steps are needed in almost every developing country to strengthen (1) the human resource base; (2) the policy framework, including enforcement of an appropriate regulatory approach; (3) the existing physical infrastructure for carrying out activities involving pathogens; and (4) the government’s commitment to nonproliferation. Discussed below are some of BTRP’s activities to these ends in the FSU. BTRP OBJECTIVES AND RESULTS BTRP’s available funds are currently focused primarily on achieving four principal objectives in the FSU, as follows: 1. Prevent the sale, theft, diversion, or unintended proliferation of bio- weapons-related materials, equipment, technology, and expertise through better control of access to biological pathogens and through greater transparency of research, surveillance, and related activities. 2. Consolidate especially dangerous pathogens into safe, secure reposito- ries at central reference laboratories (CRLs) and establish effective monitoring systems for ensuring appropriate use of these pathogens. 3. Improve capabilities to detect, diagnose, and report bioterrorism attacks and potential biological pandemics through enhanced surveillance and improved investigations of disease outbreaks. 

66 COUNTERING BIOLOGICAL THREATS 4. Catalyze strategic research partnerships involving U.S. scientists from the public and private sectors. Several positive changes in five countries of the FSU where BTRP has been most active (Russia, Georgia, Kazakhstan, Uzbekistan, and Azerbaijan) were identified in the October 2007 report. Changes observed in that report that seem to be desired outcomes of BTRP programs that might be carried out in other areas of the world include the following: • Transparency at important facilities with dual-use capabilities that had not been open to foreign specialists on a regular basis • Sharing of local databases involving pathogens with international collaborators • Improved biosecurity and biosafety programs at research and surveil- lance institutions, particularly with regard to consolidation and physical protec- tion of pathogen strains • Development of national regulations and related training programs concerning the safety and security of biological materials and good laboratory practices that meet international standards • Construction and equipping of modern research, public health, and agricultural facilities where disease-related activities of interest to both local and international specialists are carried out • Adoption by local institutions with responsibilities for controlling dis- eases of U.S.-style approaches to facility and project management, to fiscal accountability, and to inventory control • Attraction and retention of highly talented young specialists to upgraded local facilities carrying out research and providing services in the fields of public health and agriculture • Capabilities of local specialists to use effectively modern diagnostic and research equipment • Enhanced disease surveillance and response capabilities that become an integral part of the national effort • Participation in scientific conferences and training programs abroad by local specialists interested in infectious diseases who had not previously traveled abroad • Publication by local scientists in peer-reviewed international journals of their disease-related research findings that demonstrate their capabilities to participate effectively in international scientific activities • Enhanced quality of local research projects and technology transfer activities that build on the experience and expertise of participation in interna- tional collaboration  BTRP presentation to the committee, July 2008. 

APPLICABLITY OF BIOLOGICAL THREAT REDUCTION APPROACHES 67 At times, BTRP investments in the FSU have led to continuing interna- tional linkages among specialists based on friendships and common profes- sional interests. These personal contacts help build mutual respect and trust necessary for successfully addressing technical issues with dual-use implica- tions. They also provide important insights as to present and future scientific aspirations and intentions of foreign colleagues and their institutions in areas of national security interest. Finally, intergovernmental cooperation in the biological sciences and bio- technology, exemplified by BTRP activities, offers important opportunities for political and scientific leaders from the United States and partner countries to discuss common security, public health, agricultural, and scientific interests. Together they have new opportunities to develop complementary approaches for combating the threat of global terrorism. They should quickly recognize the overlaps between immediate security concerns and long-term international development priorities. APPROACHES TO EMPHASIZE IN OTHER DEVELOPING COUNTRIES A central theme of the October 2007 report was the importance of trans- forming BTRP from a Washington-directed program of foreign assistance to a genuinely collaborative program of sustained partnerships with governments that contribute substantially to the program. Of course, the governments of many poor countries are accustomed to assuming that any foreign funds com- ing into the country are foreign aid and that they should appear grateful. But if they can be convinced through both words and actions that BTRP wants them to be true partners in every step of developing and implementing cooperative programs, the path to success of BTRP will be wide and the likelihood of sus- tainability will be increased. 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. Multifaceted Approach In recent years, BTRP has increasingly recognized the importance and benefits of a multifaceted approach to international engagement as an essential aspect for achieving overlapping biosecurity, public health, and agriculture objectives. Developing countries outside the FSU have little history of deliber- ate misuse of biological assets for weapons or for bioterrorism purposes. Some of their leaders are skeptical as to the benefit of diverting woefully inadequate national resources from well-established economic development priorities to 

68 COUNTERING BIOLOGICAL THREATS BOX 3-1 Strengthening Health Systems “Strengthening health systems may sound abstract and less important than specific disease control technologies. However, without health system strengthening, there will be no results.” SOURCE: World Bank. 2007. Healthy Development: The World Bank Strategy for Health, Nutrition, and Population Results, p. 5. Available online at siteresources.worldbank.org/HEALTHNUTRI- TIONANDPOPULATION/Resources/281627-1154048816360/HNPStrategyFINALApril302007. pdf. Accessed November 30, 2008. programs for preventing bioweapons proliferation. Therefore, a multifaceted approach that addresses their development priorities as well as the priorities of the international security community, and particularly BTRP priorities, has much more appeal than a narrow biosecurity agenda of activities. Very simply, they will have an incentive to embrace foreign investments if the systems that are established support their own health and agriculture priorities, both in the near term and in the long term. As previously noted, the BTRP approach has included not only enhance- ment of facility security but also jointly developed disease surveillance activities, collaborative research projects, implementation of biosafety procedures, and development of human resources. The near-term payoffs from investments in research and surveillance are difficult to measure. But in the longer term, they strengthen scientific capabilities and can be significant activities to help detect misuse of pathogens and to respond promptly to incidents resulting from misuse. As a primary example of responding to multiple biological threats, strengthening the entire health system is essential, as indicated in Box 3-1, although programs other than BTRP must carry most of the burden in this regard. The wide variety of recommendations throughout the reports of the World Bank reflects the importance of a multifaceted approach to upgrading bios- ecurity capabilities. This approach is underscored in Recommendation 2-1 of Chapter 2 (page 50). Country Assessments and Strategic Plans During the past several years, BTRP has developed “Science Plans” to document and clarify its approach in countries in the FSU where it has pro- grams. An elaboration of this general concept is applicable to other countries where BTRP plans to invest its resources. 

APPLICABLITY OF BIOLOGICAL THREAT REDUCTION APPROACHES 69 Initially, BTRP focused in large measure on targets-of-opportunity. For example, if an important facility was not well secured and upgrades were of immediate interest to a partner government, BTRP would invest in physical upgrades. If an important research group had demonstrated a capability to obtain interesting research results, BTRP would support the researchers. If virulent pathogen strains were being used, BTRP would support biosafety training. This approach provided good entry points into different countries while addressing significant problems. In the long run, however, it might have been more effective to launch activities within the framework of more comprehensive nationwide analyses. 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 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. Development of country-specific Strategic Plans should begin during the process of BTRP’s selection of countries for engagement. The first step should be multidisciplinary countrywide assessments carried out jointly with partner governments, particularly with the ministries of health and agriculture. Also, ministries of science and education should be involved, given their portfolios of direct relevance to BTRP interests. Of course, achieving coordination of these fragmented interests will not be easy. In many developing countries, such minis- tries are often so weak that they have difficulties with their own responsibilities, let alone with interfacing with other ministries. While mutual acceptance of these assessments will probably require resolution of controversial issues, they nevertheless should be prepared without delay—that is, in months, not in years, which has too often been the case in addressing nationwide issues in the FSU. The plans should be regularly updated. The Strategic Plans should have several characteristics that have not always been embraced by BTRP in the FSU, including the following: • A Strategic Plan should be jointly developed with organizations desig- nated by the partner government. • A Strategic Plan should be consistent with U.S. government-wide biosecurity and related objectives in the country. The plan should, of course, reflect host-country priorities while being consistent with BTRP’s interests and capabilities. • A Needs Assessment (see Box 3-2) that is jointly developed should be an important component of the plan. It should analyze current and potential 

70 COUNTERING BIOLOGICAL THREATS BOX 3-2 Needs Assessment “In public health, an initial ‘needs assessment’ in a target population is critically impor- tant. It gives an estimate of the burden of disease or need, it describes gaps in services or responses, it provides a basis for setting priorities for interventions, it provides a baseline for estimates of program progress or success, and it begins the partnership and local ownership and helps build sustainability by breaking down barriers among disciplines and among local government agencies.” SOURCE: American health policy analyst commenting on the importance of country-specific needs assessments as important missing components of the TADR program, July 2007. disease-related problems, including disease burdens throughout the country, the significance of these burdens, and current and recommended approaches to responding to the diseases. • The plan should address the four common weaknesses in developing countries discussed in Chapter 2: human resources, policy frameworks, physical infrastructures, and host-government commitments to biosecurity. • The plan should describe anticipated activities by BTRP while empha- sizing steps to ensure sustainability of activities initiated under the auspices of BTRP. • It should take into account relevant activities of other external parties as well as local activities. • Emphasis should be given to engagement of both leading specialists and promising young specialists in the host country. • The planned activities should be attractive to potential U.S. collabora- tors with appropriate skills and experience. • The plan should include BTRP’s time-limited exit strategy. Also, the plan should provide for early exit by BTRP should political or other develop- ments negate the value of continued BTRP involvement in the country. Both the World Bank and the United Nations Conference on Trade and Development (UNCTAD) are preparing a series of Science, Technology and Innovation Policy (STIP) reviews. These STIP reviews address many (albeit, not all) of the broader science and technology policy issues addressed in this report. The main government counterpart for these reports is typically a min- istry of science or education. It may not be too difficult to incorporate many BTRP issues and concerns into ongoing STIP reviews, especially if this is seen as part of a broader U.S. government initiative focused on such high-priority 

APPLICABLITY OF BIOLOGICAL THREAT REDUCTION APPROACHES 71 items as capacity building in the agricultural and health sciences, laboratory upgrades, student scholarships, cooperative research programs, and faculty improvement programs at local universities. Such cooperation with the World Bank and UNCTAD would probably add considerable credibility to BTRP’s approach. Pathogens of Interest Initially, BTRP focused on a limited number of especially dangerous patho- gens that were considered as likely agents for bioweapons, for example, biologi- cal agents linked to anthrax, smallpox, plague, Ebola, Marburg, and tularemia. While BTRP quickly found a common understanding of the basis for this emphasis within the formerly weapons-related facilities in Russia, these patho- gens were of limited interest to the Ministry of Health in Russia and to many ministries in the other states of the FSU. There were too many other diseases of more immediate health and agriculture concern. Therefore, receptivity among many important officials and scientists of the FSU to such a short list of espe- cially dangerous pathogens was not high. Also, many host-government officials were focused on preventable diseases of priority interest to the World Health Organization, ranging from polio to HIV/AIDS to tuberculosis. At the same time, the economic situation throughout the FSU was critical. Most local officials succumbed to the attraction of external funds, however tar- geted, to help offset economic hardships. But as economic conditions improved, external funding became less of a dominant factor in promoting the program, at least in the oil-rich countries of Russia, Azerbaijan, and Kazakhstan. It is unlikely that many countries outside the FSU will be attracted by a short list of especially dangerous pathogens or by even the entire Select Agent List of 72 pathogens. Indeed, in the United States and other industrialized countries, the Select Agent List is too limited as a focal point in establishing priorities, as has been demonstrated with the emergence of severe acute respira- tory syndrome. Again, the partner governments may be attracted by external funding for currently underpaid scientists, regardless of the agents to be tar- geted. But such a rationale does not bode well for sustainability after BTRP departs the scene. In short, BTRP should focus on building capacity that will be helpful in addressing many diseases. To its credit, BTRP has gradually expanded its list of diseases and agents of interest in the FSU. First, it focused on certain syndromes, such as illness requiring hospitalization, as indicators of the presence of diseases of concern, as well as on a list of especially dangerous pathogens. The syndrome approach enabled local officials and scientists responsible for surveillance activities to address many pathogens of interest. Second, BTRP has added a few diseases of global concern to the BTRP core portfolio, including avian influenza, swine fever, and cholera. Local interest in these diseases has been high in some areas 

72 COUNTERING BIOLOGICAL THREATS of the FSU. (See Box 2-2 for the list of diseases and pathogens that are currently considered by BTRP to be of priority interest.) Recommendation 3-3: As BTRP considers engagement in developing coun- tries outside the FSU with little or no history of biological warfare or bioter- rorism activities, BTRP should continue to expand its list of pathogens of interest to include pathogens of high-priority local interest. Other DOD programs have projects devoted to HIV/AIDS and to malaria and other tropical diseases that are threatening populations. While BTRP is not equipped to address these diseases, it can partner with other entities that have the needed expertise. The inclusion of such diseases in BTRP’s portfolio, rec- ognizing that the more traditional biological weapons agents must still receive appropriate priority, is important. In short, poor countries cannot afford both a separate surveillance system for pathogens of bioterrorism concern and a sur- veillance system for other disease agents. They are already well attuned to the International Health Regulations, and they should build on, and not compete with, these regulations, which help identify the many pathogens of interest. Facility Upgrades and Integrating Contractors The upgrading of research, surveillance, and related facilities has been at the center of BTRP’s activities in the FSU. BTRP has relied almost entirely on U.S. integrating contractors to design and implement the upgrades. The contractors employ local subcontractors and local personnel for most of the required labor. Much of the construction material has been imported, some- times without adequate consideration of local supplies that are available. How- ever, now BTRP is relying more heavily on locally purchased materials and approaches that reduce long-term maintenance challenges when BTRP is no longer on the scene. This approach bodes well for sustainability. In general, committee members have observed that the quality of facili- ties built or upgraded by BTRP contractors is usually state of the art. Modern construction makes a favorable impression on both local government officials and researchers who had become accustomed to working in rundown facili- ties. However, there has also been negative reaction to the expensive made- in-America approach. The U.S. contractors have often been criticized by local counterparts for using funds for imported materials and services that should have gone to local construction organizations and for not being sensitive to local priorities when working out details. On occasion, the practices of contrac- tors are not appropriate and lead to criticism, as indicated in Box 3-3. But, the need for facility upgrades that are sustainable in countries within the FSU is extensive, and responding to that need has been complicated, as indicated in Box 3-4. Conditions in developing countries beyond the FSU prob- 

APPLICABLITY OF BIOLOGICAL THREAT REDUCTION APPROACHES 73 BOX 3-3 Criticisms of BTRP’s Integrating Contractors “Many problems have resulted from BTRP reliance on intermediary contractors who control budgets and do not inform institutes of details of budgets. Also, there is a lack of flexibility in budget practices of contractors, with all funds committed at the beginning of projects even if projects need to change. Perishable items (e.g., growth mediums and enzymes) are purchased so far in advance that they are out of date and unusable when they are needed.” SOURCE: Georgian senior scientist, April 2007. “Some hardware ordered by the American contractor fails to meet our specifications. For example, freezer plugs don’t fit our power outlets, vortex devices have no plugs, and the centrifuge does not match Eppendorf tubes.” SOURCE: Kazakhstani manager of BTRP project, April 2007. BOX 3-4 Upgrading Facilities in the FSU “We are not just dropping projects into well-equipped institutes that have staffs that are trained in modern techniques, that have biosafety programs up to U.S. standards, and that have animal-use protocols that would pass in the United States. We have to start with none of these and set them all up. This is an engagement program that supports institutes that have struggled through years of very poor funding. Their infrastructures are in terrible shape, and we try to modernize them. A large portion of the costs on the U.S. side is ensuring that such modernization takes place—training people cor- rectly and designing facilities to meet U.S. standards. When the institutes are up to U.S. standards, the costs to the U.S. side will drop significantly.” SOURCE: U.S. scientific adviser to BTRP, May 2007. ably will often be worse than conditions in the FSU. BTRP has clearly learned important lessons from its early experiences with contractors in the FSU. With individual integrating contractors now receiving hundreds of million of dol- lars, the pressure has increased within DOD for these contractors to perform well, although BTRP does not have the personnel to work with them as often as is desirable. 

74 COUNTERING BIOLOGICAL THREATS BOX 3-5 Problems Encountered by BTRP Contractors • Undercapitalized and inexperienced local subcontractors • Poor workmanship of local subcontractors, which requires reworking • Complex permitting requirements • Legal requirements to meet the letter and intent of local regulations • Political developments that impact on desires of local governments to cooperate • Constant concerns over long-term maintenance and sustainability • Local disinterest in maintaining stringent timetables SOURCE: Bechtel program manager, presentation to the committee, October 8, 2008. Finally, the on-the-ground experience of contractors in overcoming obsta- cles in the FSU, such as those set forth in Box 3-5, will be important in Asia, Africa, and elsewhere. The contractors are accustomed to working in chal- lenging environments, repeatedly emphasizing the importance of pursuing systems approaches, selecting and coaching local subcontractors, navigating local and regional procurement systems, and dealing with local employment regulations. While the contractors will continue to be targets for criticism of delays and other shortcomings in implementation, BTRP could not perform without them. Recommendation 3-4: Projects requiring renovation and construction activi- ties should be an important aspect of BTRP activities in countries outside the FSU. To the extent possible, BTRP contractors should involve appropriate local institutions in all aspects of design and construction activities while of course continuing to provide quality control and accounting oversight. The long- term payoff from placing increased responsibility for renovation and construc- tion projects in local hands should be substantial even though delays may be encountered. In summary, BTRP has considerable relevant experience and well-qualified on-call contractors for physical upgrading of research, surveillance, and con- tainment facilities. Such facilities are generally in poor condition throughout the developing countries. However, host country ministries should be fully engaged in the selection of the facilities for upgrading and in the technical approaches that are used. They should help ensure that facility specifications and laboratory 

APPLICABLITY OF BIOLOGICAL THREAT REDUCTION APPROACHES 75 practices are consistent with local regulatory requirements, as well as with internationally acceptable approaches. At the same time, the World Bank, the African Development Bank, and the Asian Development Bank, among others, frequently finance laboratory upgrades as part of their ongoing agriculture, health, and science development programs. Some of these ongoing activities may be relevant for BTRP. However, it is difficult to say for certain because BTRP standards or expectations for laboratory upgrades are not clear. The U.S. government could publish stan- dards for reference laboratories and central instrumentation centers and have BTRP work actively with these multilateral development banks on laboratory upgrade programs. Cooperative Research Initially, BTRP-supported research was designed to redirect defense- oriented scientists to peaceful endeavors, to open doors and increase trans- parency in previously closed FSU laboratories, and to generate data directly related to BTRP’s program interests. The research projects have usually been developed by FSU researchers, often in cooperation with U.S. counterparts, in fields designated as important by BTRP. The scientific integrity of the projects has been ensured by peer review in the United States, as well as by field visits to the FSU laboratories by U.S. specialists. BTRP has devoted only a relatively small portion of its resources to support CBR in the FSU. Nevertheless, the results have been quite good, particularly in Russia, given the number of favorably received reviews of research results presented at international meetings. This success was partly due to parallel expenditures by BTRP for upgrading key research facilities so that they could carry out credible research of international interest. BTRP has recently encountered strong Russian government resistance to continuation of CBR. There clearly is a mismatch between CBR’s nearly exclu- sive focus on bioterrorism-related pathogens in Russia and the interest of the Ministry of Health and Social Services in projects directly relevant to diseases affecting the population on a daily basis and requiring the ministry’s attention. Also, political concerns about an appropriate DOD role are undoubtedly a factor in the ministry’s reluctance to engage with BTRP. In other states of the FSU, CBR commands strong support at both the government and the facility levels. A trend in the CBR program has been the  Appendix F of the October 2007 report lists the research projects supported by BTRP from 1999 to 2007. They ranged in size from $108,000 to $1.5 million, with a total of $21.3 million transferred to the FSU institutions where the research was conducted. The support for CBR has increased substantially in FY 2008 ($19 million) and FY 2009 ($24 million). The budgets include costs of refurbishing laboratories when necessary. Travel support and occasionally stipends have also been provided for American collaborators. 

76 COUNTERING BIOLOGICAL THREATS closer coupling of CBR projects with the development of the TADR system. In earlier times, these two activities were carried out on separate tracks. Now CBR projects are increasingly justified as contributing in both the short term and the longer term to improved disease surveillance and response. Such coupling may also be appropriate in countries outside the FSU that are upgrading surveillance and response capabilities. All recent CBR projects have involved U.S. collaborators from DOD’s research organizations. Most have also included one or more additional U.S. collaborators from other government or academic research organizations. Reciprocal visits have been the norm. Consequently, many U.S. scientists now have a vested interest in research carried out in the FSU. Projects in fundamental research that provide underpinnings for long-term surveillance activities, in addition to those with prompt applications of results, are of increasing interest to CBR. This interest is particularly high in several countries in Central Asia and the Caucasus. A sharper focus on fundamental research should attract additional leading experts from home and abroad to the program. In this regard, CBR currently lists the following research areas of particular interest: • Genomics: detection and phylogenetic relationships of smallpox and hemorrhagic fevers • Diagnostics: development of collection, detection, and identification technologies • Immunology: identification of antigens and adjuvant development • Disease surveillance: development of methods for pathogenic strain characterization and related epidemiological studies • Therapeutics: manipulation and development of antivirals, antibodies, and bacteriophages For many developing countries outside the FSU, such topics seem quite advanced and perhaps out of reach. Yet limited efforts on a highly selective basis could be useful in introducing particularly talented researchers to inter- national trends. They could also contribute in the longer term to improved understanding of country-specific strains and related scientific uncertainties that are not being addressed by the international scientific community. Some governments of developing countries outside the FSU should be enthusiastic about participating in the CBR program if the administrative arrangements are consistent with the approaches already used in their coun- tries in working with international development agencies and other supporters of science. Also, the five overseas DOD research laboratories have extensive experience in reaching out to local research communities and seem well posi- tioned to serve as an important link in BTRP’s research engagement with other countries. Occasionally, there are frictions between the laboratories and local 

APPLICABLITY OF BIOLOGICAL THREAT REDUCTION APPROACHES 77 officials (for example, in Indonesia), but these are the exceptions. The U.S. Centers for Disease Control and Prevention (CDC) and the U.S. Department of Agriculture also have scientific contacts around the globe and should be able to provide insights as to opportunities and problems in mounting efforts in low- and middle-income countries. Of course, the needs of each country differ, and programs will have to be customized to fit the needs. Some countries have poor physical infrastructures, and significant research will first require laboratory upgrades. Almost all coun- tries will need a substantial training component—for example, on research management, proposal preparation, and laboratory quality control—linked to research activities. Effective research cooperation usually requires long-term commitments— perhaps 8 to 10 years to firmly establish research groups in poverty-stricken countries. Since BTRP should not remain indefinitely in any country, new mechanisms for sustaining particularly promising research projects over the long term should be considered. For example, in addition to country-specific activities, BTRP should consider establishing regional or global research grant programs to assure continued support of researchers who were nurtured through country-specific BTRP programs and who have important interna- tional contacts. A good example of the importance of U.S.-sponsored research in a country with very weak capabilities is a current project supported by the U.S. Army Medical Research Institute of Infectious Diseases in the Democratic Republic of the Congo. This project is aimed at identifying and characterizing very dangerous pathogens. It underscores the importance of BTRP relying on specialists from other organizations to lead important research activities in highly specialized areas. American academics as well as government researchers can play critical roles in such BTRP-supported research projects. The World Bank has developed research and development improvement programs in a wide range of countries—for example, Kazakhstan, Chile, Brazil, Nigeria, and Uganda. These programs go beyond health and agriculture. Nev- ertheless, there may be important lessons of experience that could be gleaned from these programs and potential opportunities to link them to BTRP research interests. Such opportunities should be explored in countries of interest to BTRP where the World Bank is active. Recommendation 3-5: BTRP should support cooperative biological research in countries where it engages, even if local research capabilities are limited. In summary, cooperative research involving significant local and U.S. scien- tists from government and academia can be important for several reasons, and BTRP should continue to reach out to the U.S. academic community through the integrating contractors and directly when appropriate. It can enhance trans- parency of approaches to biological threat reduction and build trust in BTRP’s 

78 COUNTERING BIOLOGICAL THREATS intentions. In time, regional networks of BTRP-supported researchers may offer particularly important approaches to building sustainable international research relationships as well as providing results of near-term interest to the international scientific community. PROBLEMS ENCOUNTERED BY BTRP BTRP has identified the problems set forth in Box 3-6 as being major chal- lenges that have been encountered in the FSU. These same challenges are likely to be encountered in developing countries beyond the FSU. Over the years, BTRP has encountered other problems in establishing programs in the FSU. Several deserve special attention, as discussed below. They will undoubtedly arise as BTRP reaches out beyond the FSU. In addition to BTRP experience in the FSU, the experience of other U.S. and international organizations in addressing related issues should be helpful to BTRP. Bilateral Agreements, Executive Agents, and Appropriate Partners In the FSU, BTRP has signed formal agreements with ministries and other government organizations as the basis for undertaking programs. Also, BTRP has required that each host government designate an executive agent. This executive agent serves on behalf of the government in approving specific actions in the development and implementation of cooperative activities. However, this approach has not been acceptable to Russia, largely because of the reluctance of the Ministry of Health and Social Services to enter into an agreement with DOD, which is not its natural partner. Therefore, BTRP has BOX 3-6 Challenges Encountered by BTRP • Introduction of new technologies, methods, and practices creates training and sustainability challenges. • It is difficult to reach all levels of the health systems, particularly in rural areas. • Important diseases remain unaddressed. • Cultural and social change is necessary for systems to work. • Unempowered executive agents and ministries may be responsible for pro- gram activities. SOURCE: BTRP program manager, July 2008. 

APPLICABLITY OF BIOLOGICAL THREAT REDUCTION APPROACHES 79 operated in Russia within the framework of the international agreement that established the International Science and Technology Center in Moscow. This center provides facilitative services for BTRP and other foreign organizations interested in supporting science and technology projects in Russia and several other countries of the FSU. While Russia is of course unique in many respects, other countries of interest that are outside the FSU may also be hesitant to enter into the types of intergovernmental arrangements to which BTRP has become accustomed. Lim- ited levels of engagement may not require new intergovernmental agreements or may be implemented under existing bilateral military-to-military or science and technology agreements. Also, developing formal agreements may be very time consuming and raise politically difficult issues, whereas less formal arrange- ments may facilitate prompt beginnings of important engagement activities. Of course, in some cases, agreements and executive agents may be neces- sary, particularly if large construction projects are to be undertaken. But in other countries, insistence on such formal arrangements may pose unnecessary obstacles. In some low- and middle-income countries, the ministries of defense pro- vide significant health services for civilian populations and are responsible for responding to emergency situations. They may be the only ministries with adequate logistical capabilities to reach elements of the population, such as in some rural areas of Africa. Sometimes, the surgeon general of the country is a military general. Under such circumstances, it may be possible for BTRP to establish an important bond with the ministry of defense. At the same time, BTRP should ensure that the ministries of health, agriculture, science, and education are involved, either formally or informally, and are comfortable with military-to-military arrangements. Engaging the civilian as well as the military authorities in initial discussions of BTRP engagement is a critical step to this end. The local U.S. embassy can often be helpful in assessing options. Recommendation 3-6: In moving beyond the FSU, BTRP should be flexible in the types of formal commitments it requires of partner governments as a basis for cooperation. Human Resources As discussed in Chapter 2, few developing countries have adequately trained human resources in the biosciences and biotechnology to participate effectively in a robust BTRP-supported scientific engagement program. Often, many of the best specialists have emigrated, taken employment with foreign entities operating in their countries, or changed careers to fields with greater near-term remuneration. As interest in the biosciences and biotechnology con- tinues to expand, the existing and projected human resource base will become 

80 COUNTERING BIOLOGICAL THREATS even more stretched. Therefore, a large percentage of BTRP’s engagement efforts probably should be devoted to training young specialists and then pro- viding incentives for them to find key scientific positions in local institutions, as discussed in Chapter 2. BTRP has encountered human resource-related problems in the FSU. Sev- eral training programs devoted to career reorientation have been undertaken with considerable success. However, the human resource issue is different in the FSU because at the time BTRP launched its efforts there was a large pool of underemployed scientists who, after relatively brief training programs, were able to operate effectively in modern laboratories and at other facilities. Of course, there is now great concern over how to replace this older cadre of spe- cialists as they retire, but there has been time for transition. Also, the primary and secondary school systems in the FSU, despite a decrease in quality in recent years, are still much stronger than systems in almost all developing countries outside the FSU. As recommended in Chapter 2, BTRP should be prepared to support a variety of education programs and related training programs in the countries of interest for an extended period of time. To the extent that future training programs can incorporate experience from the already developed programs in the FSU, these new programs should help expand and strengthen the global biosecurity network. BTRP’s Chain of Command BTRP’s projects in the FSU have often been delayed throughout the DOD chain of command that has been established for guiding the process, coupled with stringent DOD guidelines for executing projects. In 2004, at least 27 months were required by DOD from the development of the concept for a research project to the signing of the contract with the appropriate institution in the FSU to initiate the project. Fortunately, in most cases, this time line has been substantially reduced, but it is still too long. For all BTRP activities, the overarching policy is approved by senior policy officials within DOD, who then instruct the Cooperative Threat Reduction (CTR) Program policy office as to appropriate approaches. That office in turn tasks the Defense Threat Reduction Agency (DTRA) to implement specific activities. DTRA has several levels of responsible officials, and they must in turn fill in details of the tasks that are being assigned. BTRP then normally turns the tasks over to integrating contractors, which typically employ subcontractors. Finally, the tasks reach the specialists who are responsible for on-the-ground activities. Turnover among these specialists is often frequent, on occasion result- ing in misunderstandings and failures to recognize precedents that could be helpful. The lengthy separation between the DOD policy officials who initially 

APPLICABLITY OF BIOLOGICAL THREAT REDUCTION APPROACHES 81 design the tasks and the implementers has caused difficult program situations. Instructions are sometimes delayed or must be revisited because of changes on the ground. In dealing with countries outside the FSU that have only a handful of interlocutors who are experienced with foreign providers of goods and ser- vices, BTRP should be more adept in reacting promptly with more flexibility in embracing good project ideas. Otherwise, excessive correspondence concerning BTRP may remain for months in in-boxes of a few overworked local officials who are the only empowered decision makers. Given likely sensitivities concerning DOD programs in some developing countries, misunderstandings and false expectations should be avoided to the fullest extent possible. While DOD has well-established management proce- dures for drawing on contractors as implementers of programs, the procedures developed for BTRP have been unnecessarily complex and too Washington- centric. DOD should of course ensure that requirements are satisfied, but nevertheless DOD needs to reduce the number of intermediaries between approvers of plans and implementers of projects. 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 in U.S. intentions toward the host governments. Given the many demands on senior DOD officials with responsibilities for BTRP, a strengthening of their staff capabilities devoted to BTRP would be particularly helpful in this regard. Visa Challenges Obtaining visas for travel by U.S. and foreign officials and specialists has been and will continue to be a problem in promoting meaningful engagement activities. Usually the reason for visa problems is late application for the visa. Of course, there are at times also denials for security and political reasons. The visa issue deserves attention from the outset of BTRP’s involvement in additional countries, but there must be a two-way street. Influencing U.S. visa decisions as well as partner-country decisions on visas for U.S. travelers on a case-by-case basis will not be easy. Recommendation 3-8: BTRP should give priority to adequate advanced plan- ning in order to ease visa problems for travel between the United States and partner countries in both directions. 

82 COUNTERING BIOLOGICAL THREATS Metrics and Evaluation Comprehensive metrics to evaluate the success of BTRP activities are in the early stage of development. In the past, BTRP has focused on collecting output data, for example, the number of facilities that have received security upgrades, the number of trainees in various aspects of biosecurity, the number of former weapon scientists involved in redirection efforts, the number of sustainable peaceful jobs created, the number of collaborative research products that reach the markets, and the number of joint publications in internationally recognized journals. But the metrics have not gone to the essence of the program, namely, “To what extent has the likelihood of containing outbreaks of endemic and emerging diseases and of the related terrorism aspects been increased?”  BTRP is working toward having indicators of “outcomes” of the pro- gram as well as indicators of “outputs.” This effort responds to long-standing instructions from the Office of Management and Budget to address both types of results. Now that BTRP has become the largest component of DOD’s CTR Program, increasing attention is focused on the results it is achieving. As an interim step, BTRP is expanding its reporting to Congress from one indicator of accomplishments to four indicators. The original indicator is the number of diagnostic laboratories that are built and equipped. The three new indicators are the number of cooperative biological research projects that have been completed, the number of pathogen repositories that are secured, and the number of disease surveillance networks that have become electronically operational. BTRP is also developing more-specific metrics for meeting program objec- tives and requirements. For example, an objective could be improvements in biosafety, and a metric could be positive changes in the biosafety policy of the government. An objective could be improved data sharing, and a metric could be the number of recipients of certain types of data. In this effort, BTRP should consider the work of the World Health Organization, which uses timeliness and completeness of data reporting in its metrics, and others. Box 3-7 presents an evaluation framework being developed by BTRP. It should be expanded to address other major items, such as human resources, national policies, and physical infrastructure, taking into account related efforts through DOD’s Global Emerging Infections Surveillance and Response System and other orga- nizations, such as the Department of State, the Department of Homeland Secu- rity, and CDC. Overall, the measurement effort should be strongly encour-  For related observations on metrics, see National Research Council Committee on Prevention of Proliferation of Biological Weapons. 2007. P. 62 in The Biological Threat Reduction Program of the Department of Defense: From Foreign Assistance to Sustainable Partnerships. Washington, D.C.: The National Academies Press. Available online at www.nap.edu/catalog.php?record_id=12005.  See, for example, the discussion of the efforts of the Department of Homeland Security to develop models for assessing the risk (threat, vulnerability, consequences) of bioterrorism set forth 

APPLICABLITY OF BIOLOGICAL THREAT REDUCTION APPROACHES 83 BOX 3-7 BTRP Draft Framework for Development of Metrics • Biological safety/security and laboratory practices are sustainable and con- sistent with internationally accepted best practices. • U.S. select agents are consolidated and secured. • Partner nations demonstrate sustained and transparent capability for sur- veillance, detection, reporting, and response to bioterrorism events and suspected disease outbreaks. • Scientists working with U.S. select agents are engaged in peaceful, transpar- ent, and sustainable activities. • Biological weapon infrastructure, equipment, and material are eliminated. SOURCE: BTRP, November 2008. aged within BTRP. The International Health Regulations may also provide approaches that BTRP should consider adopting (see Appendix H). In a related effort, BTRP is conducting a field evaluation of the effective- ness of TADR in Georgia. The purpose is to provide guidance on fine-tuning TADR. This evaluation includes demonstrating whether and how TADR recog- nizes extremely dangerous pathogens, promptly initiates communications from the primary health care or livestock service provider who reports an outbreak to the national level, and effectively executes other important aspects of TADR. Thus, the evaluation is to assess the effectiveness of protocols for epidemiologi- cal response and for sample collection and transportation. Finally, it addresses laboratory confirmation procedures at the regional and national levels. Inferring BTRP’s impact on a nation’s security from such evaluations, how- ever, is the most difficult task. Such a task involves understanding the security situation when BTRP entered the scene (the baseline) and the unique contri- butions of BTRP to reducing biological threats. One approach is for BTRP to support continuing assessments of BTRP impacts by both a group of specialists within BTRP in Washington and a counterpart group of local specialists in the host country focused on risk reduction. They could develop either common or competing methodologies and then compare results of their assessments. Their different insights as to how BTRP can most effectively enhance security on a broad basis in the country would be of considerable interest. in National Research Council Committee on Methodological Improvements to the Department of Homeland Security’s Biological Risk Analysis. 2008. Department of Homeland Security Bioter- rorism Risk Assessment: A Call for Change. Washington, D.C.: The National Academies Press. Available online at www.nap.edu/catalog.php?record_id=12206. 

84 COUNTERING BIOLOGICAL THREATS In short, as BTRP expands into other countries, this concern with BTRP impacts on reducing the threat of bioterrorism deserves greater emphasis. Evaluation efforts should begin from the outset of BTRP involvement in a country, because after projects are completed, it will be too late to examine reli- able indicators of risk reduction as a result of the projects. At the same time, the current midcourse review of the effectiveness of the TADR system in Georgia is a step in the right direction, even though the assumption that TADR is an appropriate approach is not being challenged by the external evaluators—a shortcoming that should be corrected in the future. Recommendation 3-9: BTRP should continue to develop improved metrics 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. SPECIAL CHALLENGES Political Aspects of a DOD-BTRP Presence in Developing Countries The United States is often criticized as seeking military domination throughout the world. Nevertheless, BTRP has been welcomed as a useful and necessary program in many countries of the FSU. Local interest in BTRP activities has been driven in large measure by financial benefits and also in some countries by a local desire to have strong U.S. support of newly independent governments to help balance the nearby Russian military presence with roots into the past. This latter type of political-military incentive to welcome BTRP is not present in many parts of the developing world. Indeed, there is a major issue of whether BTRP should help develop public health and agriculture roles in countries that are not accustomed to a highly visible U.S. military presence and have no history with biological weapons. At the same time, DOD’s record in responding to natural disasters, in conducting research on tropical diseases, and in engaging in military-to-military contacts with dozens of developing countries is impressive. The issue is not whether BTRP should be engaged outside the FSU. For the reasons set forth in Chapter 1, it should be. The issue is how BTRP should be engaged. The following suggestions are offered in this regard: • BTRP should have a deliberate but realistic timetable when initiating engagement activities. It should recognize the importance of having the local authorities understand the benefits that will be derived over time from the program and thereby buying into the program, keeping in mind that develop- ing-country governments are inundated with offers of foreign assistance from 

APPLICABLITY OF BIOLOGICAL THREAT REDUCTION APPROACHES 85 much larger donors, such as the international development banks. Similarly, BTRP should be realistic in developing timetables for carrying out projects. The partner governments and local specialists will undoubtedly have to go through a lengthy education period concerning BTRP objectives and approaches. But excessive BTRP control over activities in the name of efficiency could degrade the likelihood of sustainability. In short, prompt delivery of promised goods and services should be balanced with assurances that they will be used effectively in a manner consistent with host-country long-term interests. • 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 Organiza- tion, the World Bank, the regional development banks, the U.S. Agency for International Development, and CDC. • With the exception of BTRP activities in war-torn countries where U.S. military forces are omnipresent, such as Iraq and Afghanistan, BTRP should have a relatively modest presence in the countries of interest. This means that BTRP should have the clear objective of not only undertaking specific projects but also catalyzing international interest in complementing BTRP activities with activities of other organizations. • Finally, BTRP should not hesitate to change plans to engage in a country when the government clearly indicates a lack of interest in such engagement.  Recommendation 3-10: BTRP should take into account possible local concerns 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. Threat Assessment and Response DOD has indicated a strong interest in extending the TADR system that is being developed and deployed in the FSU to countries around the world. The system is to improve biosecurity, and it has been described by BTRP as having the following characteristics:  The plan of Africa Command (AFRICOM) to locate its headquarters in Africa is of interest. The plan was poorly received by most African governments, which were not widely consulted in advance of the announcement of the plan. Civic groups across the continent opposed what they viewed as a permanent U.S. military presence in Africa targeted on Africa’s natural resources. See Smith, G. 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 Prog- ress. Available online at www.americanprogress.org/issues/2008/06/pdf/sustainable_security1.pdf. At the same time, AFRICOM has a staff of 16 medical personnel under the command’s surgeon. They are focused on the health of military personnel, but its leadership has expressed interest to committee staff in assisting with BTRP, which has not been on AFRICOM’s agenda. 

86 COUNTERING BIOLOGICAL THREATS • Nationwide surveillance system • Close to real-time detection, reporting, and response • Integrated reporting of human health and veterinary health, including vectors • Tracking of diagnostic tests, results, and stored specimens • Electronic integrated diseases surveillance system • Diagnostic laboratory system • Standard and molecular methods that minimize culture volumes • U.S. biosafety level 2 (BSL-2), except for central reference laboratory (BSL-3) The key TADR components include the following: • Central reference laboratory (BSL-3 capabilities), where human and vet- erinary facilities are combined and a national response team is headquartered (see below) • BSL-2 diagnostic and detection laboratories at existing human and vet- erinary laboratories for disease surveillance and epidemiological analysis, case investigations involving sample transport capabilities, and disease detection and diagnostics by molecular and classic methods • Region-level support stations for disease surveillance and epidemio- logical analysis, case investigations, and disease reporting by veterinarians and epidemiologists Some aspects of this system are obviously important for many developing countries. But there may be competing systems in various stages of develop- ment in different countries. Therefore, some components of the TADR sys- tem may be appropriate for some countries, and other components, for other countries. In addition to questions as to TADR’s compatibility with other surveil- lance systems in various stages of development, several concerns about the system were expressed in the October 2007 report and have not yet been fully addressed by BTRP. • How will the TADR network be sustained after BTRP completes its participation in development and operation of the network? This means there must be substantial buy-in from a wide range of local officials and specialists with access to financial resources. • The focus of TADR should be broadened from a limited number of disease agents, classes of agents, and syndromes of interest to DOD for prolif- eration purposes to a broader range of agents that are of greater interest from human health and agriculture perspectives. It makes little sense to have differ- 

APPLICABLITY OF BIOLOGICAL THREAT REDUCTION APPROACHES 87 ent systems for different disease agents in the same country, as noted earlier in this chapter. • Automatic transmission through the TADR information systems of all data that are collected by physicians, laboratory specialists, and other partici- pants in the program will result in false alarms. Raw data are most useful at the national and regional levels, where such data influence budget allocations. Local specialists should be trained to screen the data before they are entered into the international component of the system to reduce the false alarm rate. BTRP’s haste to immediately have all of the data in the United States should be tempered with reality of the likely significance, analysis, and use of the data. • Data recipients in the United States that are BTRP partners should be prepared to accept and analyze the data as an important component of their overall missions. In the absence of such interest, a long-term program to send all raw data to the United States makes little sense. Recommendation 3-11: The design and operation of the TADR system should be carefully reviewed by a well-qualified, independent organization that has not been directly involved in the design or establishment of the system before BTRP advocates transportability of the components of the system to other countries beyond the FSU. This review should emphasize the risk-reduction potential of TADR, including its ability to strengthen local response to disease outbreaks and indi- cations that TADR is achieving this goal. Central Reference Laboratories A special concern is the plan of BTRP to construct within the TADR system central reference laboratories with BSL-3 capabilities in one or more countries of the FSU (at a cost of up to $90 million each, plus operational costs of $5-10 million annually) or in some cases BSL-2 laboratories. Prelimi- nary DOD plans call for such facilities in other countries as well. CRLs are to serve as national centers for research and surveillance systems and will include consolidated repositories for dangerous pathogen strains. The unanswered questions include the following:  There is considerable interest in some developing countries in BSL-3 and even BSL-4 laborato- ries. At the same time, there are uncertainties as to current safety designations of some of the high- containment laboratories by specialists from the developing countries. According to fragmentary information available to the committee, there is one BSL-4 laboratory operating in South Africa and two BSL-4 laboratories operating in India. As for BSL-3 laboratories, there are three in Malaysia, three in Mexico, two in Bangladesh, seven in Indonesia, five in Thailand, and 16 in India. (This information was compiled from committee field visits and from a presentation by Dr. Nicoletta Previsani on WHO’s [World Health Organization] Biosafety and Laboratory Biosecurity delivered 

88 COUNTERING BIOLOGICAL THREATS • Will there be enough demand for use of the facilities to justify the expense of constructing, maintaining, and operating them? • Is there enough local talent to adequately staff the facilities without diverting specialists from equally important assignments in other institutions? • Will there be adequate safeguards to ensure that if the host government undergoes significant political changes that lead to an estrangement with the United States that the facilities will not be used for nefarious purposes? • Would it be more appropriate to construct regional rather than national facilities, given the uncertain demand for their usage, the human resource issues, the expense, and the need for international assurance that they will not be misused over the long term? Recommendation 3-12: Before BTRP begins planning construction of CRLs outside the FSU, it should resolve issues concerning the need, location, opera- tions, and international transparency in the long term regarding the facilities to which it has committed in the FSU. Advanced Technologies Most developing countries are not prepared to adopt advanced technolo- gies such as computer-based, automated disease surveillance systems. Also, unfamiliar high-technology approaches that could be beyond the reach of local specialists might be viewed as a form of U.S. technological imperialism. This does not mean that advanced technologies should not be deployed in develop- ing countries when the circumstances are appropriate. But traditional ways of addressing disease problems should be given careful consideration. When appropriate, the latter should be incorporated into technologically upgraded approaches. Recommendation 3-13: BTRP should refrain from advocating high-technology approaches that may be inappropriate in low-technology environments. CONCLUSION In summary, the risk of bioterrorism being rooted in developing countries is too great for BTRP not to be among the leaders in addressing the threat on a broad basis. Since the late 1990s, BTRP has had unique experiences in working with states of the FSU that are at various levels of development. Much of this at the Biological Weapons Convention Meeting of Experts at Geneva, Switzerland, August 18-22, 2008, and available online at www.bwpp.org/2008MX/documents/PresentationWHO20080819.pdf.) A more complete survey would undoubtedly indicate the presence of many more BSL-3 laborato- ries throughout the developing countries. 

APPLICABLITY OF BIOLOGICAL THREAT REDUCTION APPROACHES 89 experience seems to be readily transferable to developing countries beyond the FSU. Such experience should be brought to bear in a variety of development settings as an important component of overall U.S. efforts to reduce the likeli- hood of bioterrorism throughout the world. At the same time, BTRP should recognize that other international or local organizations themselves may be better positioned, better equipped, or both to upgrade specific biosecurity weaknesses that deserve prompt attention. Also, BTRP should ensure that its activities are carried out within the framework of the overall U.S. government approach to biological threat reduction, including the selection of countries and problems within countries that need attention. Several of the recommendations in this chapter are designed to broaden the approach of BTRP from a narrow focus on specific pathogens, and indeed only on agents that cause human and animal diseases, to the broader science and technology agendas of developing countries, including science and technology policies, higher education, and improvement of research. Casting this wider net should reveal an array of opportunities both for BTRP and for the broader U.S. and international communities to make meaningful contributions to enhancing biosecurity in developing countries. BTRP should not become involved in all situations that need prompt attention, and particularly those that are a more logical focus of attention of other organizations that also have access to necessary resources. BTRP may be able to address such situations faster, more comprehensively, and with more expertise than other organizations, but the biosecurity problems are so numer- ous throughout the world that BTRP should not hesitate to let other interested organizations take the lead when possible.