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

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Introduction The U.S. Congress included in the National Defense Authorization Act for Fiscal Year 2008 (P.L. 110-181, Title XIII, Section 1308) a provision calling for a study by the National Academy of Sciences (NAS) on “the prevention of pro- liferation of biological weapons.” This study, which is the topic of this report, was to identify areas for future cooperation with developing countries outside the former Soviet Union (FSU) within the framework of the Cooperative Threat Reduction (CTR) Program administered by the Department of Defense (DOD) in the specific area of prevention of proliferation of biological weapons. Such biology-oriented activities, whether carried out within the FSU or elsewhere, are currently referred to by DOD as the Biological Threat Reduction Program (BTRP). During 2007, the National Research Council (NRC), acting on behalf of the NAS, conducted a related study of BTRP activities that had been carried out in cooperation with the states of the FSU, pursuant to the National Defense Authorization Act for Fiscal Year 2007 (P.L. 109-364, Title XIII, Section 1304). The NRC submitted the report of that study to DOD and to the Congress in the fall of 2007. The title of that report is The Biological Threat Reduction Program of the Department of Defense: From Foreign Assistance to Sustainable Partnerships. Against this background, the NRC welcomed the opportunity to undertake a second study of the potential role of BTRP in promoting U.S. interests in countries of security importance.  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. This report is hereinafter referred to as the “October 2007 report.” 13 

14 COUNTERING BIOLOGICAL THREATS In March 2008, the NRC entered into a contract with the Defense Threat Reduction Agency (DTRA), acting on behalf of DOD, to carry out this study. This report sets forth the findings and recommendations of the Committee on the Prevention of Proliferation of Biological Weapons in States Beyond the Former Soviet Union, which was established by the NRC to undertake the study. Also included in the National Defense Authorization Act for Fiscal Year 2008 (Section 1306) was a provision calling for an NAS study of new initiatives for the CTR Program. In response, a separate report has been prepared by the NRC Committee on Strengthening and Expanding the Department of Defense Cooperative Threat Reduction Program and is scheduled to be released in March 2009. Since that report covers issues in the nuclear, chemical, biologi- cal, and missile fields, there is some overlap with this report. Nevertheless, each report stands on its own, and they are intended to be complementary. DOD and the U.S Congress will be important audiences for this report. At the same time, BTRP has far-reaching implications for many governmental and nongovernmental organizations (NGOs) in the United States and abroad. Thus, the report should also be of wide interest to officials, health and agriculture practitioners, researchers, entrepreneurs, industrialists, foundation leaders, and policy analysts in several countries. STATEMENT OF TASK The four tasks to be addressed in the study as set forth in the legislation and in the subsequent contract between NAS and DTRA are as follows: 1. An assessment of the capabilities and capacity of governments of devel- oping countries to control the containment and use of dual-use technolo- gies of potential interest to terrorist organizations or individuals with hostile intentions. 2. An assessment of the approaches to cooperative threat reduction used by the states of the FSU that are of special relevance in preventing the prolifera- tion of biological weapons in other areas of the world. 3. A brief review of programs of the U.S. government and other govern- ments, international organizations, foundations, and other private-sector enti-  See Appendix L for biographical information on the committee members. 3 National Research Council Committee on Strengthening and Expanding the Department of De- fense Cooperative Threat Reduction Program. 2009. Global Security Engagement: A New Model for Cooperative Threat Reduction. Washington, D.C.: The National Academies Press.  Congressional staff members have clarified for the committee that the intent of Congress was to limit “the approaches to cooperative threat reduction” to the approaches undertaken by the states of the FSU in cooperation with BTRP and not include approaches that may have been undertaken unilaterally by the states or through other international programs. This is the interpretation used in this report. 

INTRODUCTION 15 ties that may contribute to the prevention of the proliferation of biological weapons. 4. Recommendations on steps for integrating activities of the CTR Pro- gram relating to biological weapons proliferation prevention with activities of other departments and agencies of the United States, as appropriate, in states outside the former Soviet Union. In addition, the contract provides the following guidance for the study: • In response to a request by DOD, the study will have a special focus on activities in Asia and Africa. • For the purposes of this study, “the prevention of proliferation of bio- logical weapons programs” is defined by DOD as “those activities that could be carried out by DOD unilaterally or in cooperation with other U.S. government departments and agencies, contractors, nongovernmental organizations, and international organizations for the purpose of the prevention of proliferation of biological weapons-related materials, technologies, and expertise.” Finally, DOD informed the NRC that the study should not address the situ- ation in Iraq, which in DOD’s view has attracted sufficient attention through other DOD channels. ELABORATION OF IMPORTANT CONCEPTS Dual-Use Capabilities The dual-use dilemma encompasses a wide range of biological capabili- ties that are intended for use in carrying out legitimate research, produc- tion, surveillance, therapeutic, and related activities. These capabilities include technical expertise of specialists who are trained or who have experience in addressing disease-related issues; methodologies that are used to character- ize and manipulate biological systems; biological materials that are used for disease-related activities in laboratories, clinics, production facilities, and field investigations; and equipment that is essential for a wide range of biology- related activities. Unfortunately, many of these capabilities can be used for malevolent purposes. Dual-use capabilities permeate a large portion of life sciences and bio- technology activities throughout the world, and the scope of dual-use activities continues to grow. Appreciation of this broad concept of dual use is essential in considering how to reduce the likelihood of proliferation of biology-related activities that could be used to cause harm. The recognition of the possibility of dual-use capabilities falling into the hands of hostile military forces, terrorist groups, or disgruntled individuals underlies many of the concerns set forth in the legislation calling for this study. 

16 COUNTERING BIOLOGICAL THREATS The National Science Advisory Board for Biosecurity (NSABB) has dis- cussed dual-use research in considerable detail. The discussions of dual-use research by the NSABB have particular salience in a few developing countries with well-developed research capabilities. Most developing countries outside the FSU are not capable of conducting dual-use research designed to alter the properties of existing organisms through molecular technologies, but many of these countries conduct or could conduct applied research using organisms of concern for biological warfare or bioterrorism. Thus, NSABB reports provide useful guidance for addressing long-term research problems throughout the world. In this regard, NSABB has involved specialists from many developing countries in workshops and meetings that it has sponsored (see the organiza- tion’s Web site at www.biosecurityboard.gov). Biological Weapons and Bioterrorism The legislation calls for the study to address proliferation of “biological weapons.” For the purposes of this report, biological weapons include any biological material that could be deliberately misused to cause significant harm to humans, livestock, other agricultural resources, or environmental resources. This definition covers specific pathogens that could be disseminated in a wide variety of ways for harmful purposes. The definition helps provide a conceptual umbrella for the activities of BTRP. It broadens the past focus by BTRP to include all agents that could be used for either biological warfare or biological terrorism. The distinction between biological warfare agents and biological terrorism agents is particularly important in considering expansion of BTRP beyond the FSU into countries with no history of involvement in preparation for biological warfare. Specifically, preparation for biological warfare requires a large physical and human infrastructure. A significant quantity of a refined stabilized product that can be packaged, stored, and delivered is needed. The products are usually milled dry powders measuring 1 to 10 microns in particle size that remain sus- pended in air when released. Only a relatively small number of biological agents fit this profile, and few developing countries beyond the FSU have experience with such agents or the equipment required for production and release. As to bioterrorism designed primarily to create widespread fear, a small amount of unrefined product may be sufficient to achieve the objective. For  See, for example, National Science Advisory Board for Biosecurity. 2007. Proposed Framework for the Oversight of Dual-Use Life Science Research: Strategies for Minimizing the Potential Misuse of Research Information. Bethesda, MD: U.S. Department of Health and Human Services. Avail- able online at oba.od.nih.gov/biosecurity/pdf/Framework%20for%20transmittal%200807_Sept07. pdf. 

INTRODUCTION 17 this purpose, the agent may be easily accessible in nature and introduced into an unsuspecting community in a simple manner. Genetic manipulation, sophis- ticated technology, biohazard suites, or highly engineered delivery systems may not be needed. There may be no need to scale fences or pass armed guards to obtain the product, which could be abundant in nature and routinely encoun- tered in areas where the associated disease is endemic. Trained microbiologists might easily acquire suitable organisms from the environment or from a rural health clinic or veterinary station to create a bioterrorism event. A good example of an agent that requires little technology for use in bioter- rorism is foot-and-mouth disease virus. This virus is endemic in many countries and could with limited technical capabilities be introduced into countries free of the virus. Large quantities of the virus could be produced in developing countries in a stable form by a simple procedure such as lyophilization (freeze drying) and then transported internationally to the United States or other Western countries. The topic of pathogens of concern is addressed throughout the report. Biosafety and Biosecurity These terms are commonly used to describe a variety of activities related to the proliferation of biological weapons as discussed in the preceding para- graphs. However, they often have different meanings for different audiences. For the purpose of this report, biosafety includes “the application of knowl- edge, techniques, and equipment to prevent personal, laboratory, or environ- mental exposure to potentially infectious agents or biohazards.” Biosafety procedures have been widely published, and they should conform to interna- tional standards, with an emphasis on facility containment practices to protect the worker. In this report, biosecurity encompasses all direct or indirect measures that contribute significantly to (1) preventing inappropriate persons from gaining access to materials, equipment, or technology that could be used in producing biological weapons; or (2) detecting, characterizing, or responding to outbreaks of diseases that involve biological pathogens or toxins. It is an overarching concept that includes measures taken at the international, national, and local levels that reduce the likelihood that pathogens could be deliberately misused. It encompasses, but is much broader than, biosafety.  This definition is taken from the dictionary of medical terms available online at www.medterms. com/script/main/art.asp?articlekey=33817. Accessed November 26, 2008. 

18 COUNTERING BIOLOGICAL THREATS Biosurety This term was developed within DOD during the 1990s. However, given the lack of familiarity of many potential readers of this report with the term, it is not used in this report. Roots of Terrorism BTRP should, of course, consider the root causes of terrorism in the coun- tries where it has engagement programs. Specifically, what motivates or induces people in the developing countries to resort to terrorism in general and perhaps trigger bioterrorism events in particular? Understanding terrorist motivations is important, both to provide insights on the political and economic environments and to help identify ways that BTRP activities can contribute to reducing the risks of bioterrorism. Credible analyses of the likelihood of bioterrorism must take into account the extent of the roots of terrorism in the specific countries of interest. However, such country-specific analyses are clearly beyond the scope of this report. A few comments on economic development challenges, which in some countries may relate to the roots of terrorism, are offered in this report, but broad-ranging assessments of the roots of terrorism are left to others. Countries of Concern and Country Visits U.S. and foreign specialists have identified in various publications and in presentations to the committee dozens of countries with biosecurity vulnerabili- ties. Some specialists believe that conditions in selected countries should be of immediate concern to the U.S. government. They also believe that many other countries should be of biosecurity concern in the longer term. Some countries with significant vulnerabilities are identified in Chapters 1 and 2. However, the time and the resources for this study were limited. Thus, it was not possible to analyze in detail the biosecurity situations in individual countries. Also, the committee did not have access to classified information; and it had only a limited opportunity to obtain unpublished information from within the developing countries that would be needed for comprehensive analyses.  DTRA has characterized biosurety as follows: It includes (1) compliance with approved safety, environmental, occupational health, operational, and technical procedures; (2) physical security measures to preclude unauthorized access to or use of especially dangerous pathogens and pro- tection of knowledge and intellectual property; (3) safe and secure acquisition, storage, handling, maintenance, transportation, inventory management, and disposal of especially dangerous patho- gens; (4) emergency response to biological mishaps and incidents; and (5) personnel reliability. Thus, biosurety is intended to be a total concept that encompasses the practice of biosecurity at all levels, including biosafety. It also includes personnel reliability to ensure proper clearance and tracking of individuals who work with especially dangerous pathogens. 

INTRODUCTION 19 Two general limitations are included in the statement of task as to the countries that should be considered in the study. First, the countries of inter- est are “developing countries.” The list of developing countries prepared by the World Bank, which includes both middle- and low-income countries, has been used as guidance in identifying relevant countries. Second, the countries should be outside the FSU. The Baltic states of Estonia, Latvia, and Lithuania are among the currently independent countries that were at one time within the Soviet Union, even though there have long been diplomatic disagreements over whether those countries were legally incorporated into the FSU before its disintegration in 1991. Two other practical considerations further limited the list of countries of interest. First, the situations in Afghanistan, Iraq, and other war-torn countries were too complicated to be addressed. Second, the internal and external politi- cal situations of countries that might be of interest in the long run ruled out some countries from consideration, recognizing that political acceptability is often difficult to predict. For example, Cuba, Iran, and Syria would not seem to be appropriate countries to consider for BTRP engagement in the near term. While the committee is concerned about the lack of adequate biosecurity condi- tions in North Korea, only limited information about conditions in that country is publicly available. If BTRP proceeds as recommended in this report, the list of countries of interest will undoubtedly change significantly over time. As noted above, the committee did not attempt to carry out in-depth country studies. Rather, field visits by committee members provided limited sets of observations on examples of biosecurity issues that deserve particular atten- tion. Also, reports of site visits by other U.S. specialists to facilities in countries at different stages of economic and technological development helped clarify conditions on the ground in a range of development and biosecurity settings. In short, objectives of the field visits were limited. They were not intended to prioritize countries for BTRP consideration or to help jump-start BTRP activities in specific countries. Also, they were not intended to rule out coun- tries as not being of high priority for BTRP.10 Rather, they were case studies to provide insights into important generic issues that must be addressed by the  A link to the list of countries and an explanation of the classification system is available online at go.worldbank.org/K2CKM78CC0. Accessed December 2, 2008.  Useful insights on conditions in North Korea were presented by Karl A. Western in “Infectious Diseases in the Democratic People’s Republic of Korea” at the National Institutes of Health, June 9, 2008. However, at present, DOD is barred by law from providing assistance to North Korea, although it can seek a Congressional waiver. 10 Country priorities are being addressed by an interagency committee assisted by private-sector specialists. See, for example, International Biological Threat Reduction Program, Sandia National Laboratories. 2009. Global Biological Threat Prioritization Pilot Study. Unclassified summary provided to the committee, January 12, 2009. 

20 COUNTERING BIOLOGICAL THREATS U.S. government in prioritizing countries for BTRP engagement and in devel- oping BTRP engagement strategies and programs. They provided supporting material for the recommendations set forth in this report. The field visits were limited in number and constrained in scope by the short time available for planning, obtaining clearances for, and carrying out the visits, as well as analyzing their results—a total of 4 months. Visits to four countries were arranged pursuant to the contract between NRC and DTRA: Morocco, Mexico, Malaysia, and the Democratic Republic of the Congo. These countries provided opportunities to observe a range of geographic and devel- opment settings and a variety of levels and types of U.S. and international involvement. The agendas for these four visits and summary reports are set forth in Appendix C. Also, brief consultations in Brazil, Colombia, and Thai- land took advantage of itineraries arranged by individual committee members and financed through other channels. Observations during both sets of visits are reflected in appropriate places throughout the report. Thus, the committee had a reasonably good appreciation of relevant secu- rity, economic, scientific, health, and agricultural situations in several countries of interest. Legislative Authorities With regard to legislative approaches, this report assumes that Congress will not appropriate funds for nonproliferation purposes directly to the Depart- ment of Health and Human Services (HHS), the Department of Agriculture (USDA), or the Environmental Protection Agency. Rather, funding for those organizations for nonproliferation purposes will continue to be provided from appropriations to the Department of State or DOD when those organizations consider such funding to be appropriate. However, the related report by the NRC Committee on Strengthening and Expanding the Department of Defense Cooperative Threat Reduction Program suggests that, alternatively, nonprolif- eration funds might be appropriated directly to HHS and USDA. Thus, this report focuses on how DOD uses the funds for which it has responsibility. It does not address how some of these funds, in the first instance, might be better appropriated to other agencies. In either case, the recommenda- tions in this report should provide useful suggestions as to the important roles of HHS and USDA, as well as DOD, in addressing proliferation challenges in developing countries outside the FSU. Related to the foregoing discussion is an often-heard argument that other agencies could do the job of reducing biological threats in developing coun- tries without the need for DOD involvement. The committee strongly believes that for many years DOD has demonstrated that it can bring unique skills and experiences to the field that are not readily available to other agencies in areas such as facility and personnel security, project management in difficult 

INTRODUCTION 21 environments, logistics, and training of a wide range of specialists. This topic is discussed throughout the report. THE STRUCTURE OF THE REPORT The report is presented in 6 chapters and 12 appendixes. Chapters 2 to 5 respond to the four tasks in the legislation calling for this study and present relevant recommendations. Chapter 6 consolidates the recommendations. • Chapter 1 highlights the security context for potential BTRP activities in developing countries, including near-term concerns over containment of patho- gens. Several issues are identified that should be addressed in initiating BTRP activities designed to help counter the proliferation of biological weapons. • Chapter 2 addresses the capacities of developing countries to take advantage of achievements in the life sciences while containing potentially dangerous materials, expertise, and technologies. Capacity is directly linked to weaknesses of developing countries in effective biosecurity-related policies, adequate human resources, and appropriate physical infrastructures (see Task 1). • Chapter 3 discusses some of the approaches used by BTRP in the FSU that seem appropriate for deployment in other countries. It points out signifi- cant differences between the biosecurity environments in the states of the FSU where biodefense activities were widespread during the Soviet era and the environments in other developing countries where biodefense activities have been very limited (see Task 2). • Chapter 4 highlights activities in the life sciences supported by many international, governmental, and nongovernmental organizations in the devel- oping countries that are important in considering an appropriate niche for BTRP. While a comprehensive inventory of such activities has not been under- taken, many of the most important activities are discussed, with pointers to other activities (see Task 3). • Chapter 5 addresses the importance of coordination of U.S. government nonproliferation and related international efforts and the need to integrate these efforts internally and with activities of other governments, international organizations, and the private sector (see Task 4). • Chapter 6 consolidates the recommendations that have been set forth and indicates priorities among these recommendations. The appendixes provide references and other supporting documentation for the discussions in the report. 

22 COUNTERING BIOLOGICAL THREATS INFORMATION SOURCES This report is based primarily on information that was available as of November 30, 2008. The committee members and the NRC staff reviewed many relevant reports prepared by officials and specialists from the developing countries, by U.S. and other international participants in biosecurity activities, and by other knowledgeable observers. A few key documents are cited in the text, footnotes, and appendixes of the report. The October 2007 report provides a comprehensive overview of BTRP activities in the FSU. The information in that report was supplemented by updated information collected by NRC staff who attended the annual BTRP program review conference held in Garmisch, Germany, in April 2008. This conference involved officials and specialists that participate in BTRP in seven countries of the FSU. In addition, DOD and DTRA officials briefed the com- mittee on their outlooks for future BTRP activities. Thus, the committee had significant insights as to the successes and challenges associated with BTRP in the FSU as a starting point for consideration of expansion of BTRP to other countries. DTRA provided the committee with information concerning the interna- tional biology-related activities of several units of DOD, as discussed in Chapter 3. Important overview reports are DOD’s Global Emerging Infections, Surveil- lance and Response System11 [GEIS] and the Institute of Medicine’s Review of the DOD/GEIS Influenza Programs: Strengthening Global Surveillance and Response.12 Also of special significance for this report has been a review of the inter- national development literature. Significant reports have been prepared by development agencies and independent specialists concerning human resource development, health and agriculture programs, and physical infrastructure deficiencies in developing countries. Consultations with specialists associated with the World Bank, the private sector, and the NGO community helped fill gaps in the published literature. Helpful briefings and associated documents were provided by the Depart- ment of State, the Department of Agriculture, and the Department of Health and Human Services (particularly the Centers for Disease Control and Preven- tion, the National Institute of Allergy and Infectious Diseases, and the Fogarty 11 U.S. Department of Defense. 2007. DoD Global Emerging Infections Surveillance and Re- sponse System Annual Report Fiscal Year 2006. Silver Spring, MD: DOD. Available online at www. geis.fhp.osd.mil/GEIS/aboutGEIS/annualreports/GEIS_06_HR.pdf. Accessed December 2, 2008. 12 Institute of Medicine Committee for the Assessment of DoD-GEIS Influenza Surveillance and Response Programs and Board on Global Health. 2007. Review of the DoD-GEIS Influenza Programs: Strengthening Global Surveillance and Response. Washington, D.C.: The National Academies Press. Available online at www.nap.edu/catalog.php?record_id=11974. Accessed De- cember 2, 2008. 

INTRODUCTION 23 International Center). The insights of the Department of State were especially important. This department has had the most active nonproliferation program of all U.S. government agencies directed explicitly to biosecurity in developing countries beyond the FSU. Also of particular significance are the activities of the World Health Orga- nization, the Food and Agriculture Organization, and the Animal Health Orga- nization. Several committee members and staff have had extensive contacts with specialists of these organizations. Given these contacts and the ready availability of documents of the activities of the organizations, formal consultations in Europe or the United States were not pursued.13 As for previous activities of the National Academies, Appendix J identifies several relevant reports. In addition, the National Academies carried out inter- national workshops on biosecurity and biosafety in Poland (November 2007), Uganda (February 2008), and Hungary (March 2008). These events involved specialists from more than 20 countries. Information developed at the work- shops was available to the committee. Finally, comments by knowledgeable specialists from around the world set forth in the boxes throughout the report present a limited sampling of views that are relevant to past activities of BTRP and its future activities beyond the FSU. 13 See, for example, World Health Organization. 2008. Guidance on Regulations for the Trans- port of Infectious Substances 2009-2010. Available online at www.who.int/csr/resources/publica- tions/biosafety/WHO_HSE_EPR_2008_10.pdf. See also World Health Organization. 2006. Biorisk Management: Laboratory Biosecurity Guidance. Available online at www.who.int/csr/resources/ publications/biosafety/WHO_CDS_EPR_2006_6.pdf.