The distinctions between natural, accidental, and intentionally initiated outbreaks have blurred, and all can result in exposure of U.S. military, civilian, and animal populations to deadly diseases, creating catastrophic health, economic, and political impacts that potentially can destabilize nations and affect security in geographic areas of responsibility. By engaging and working collaboratively with partners and counterparts in selected countries at risk of biothreats, the U.S. Department of Defense (DOD) Biological Threat Reduction Program (BTRP) is well poised to improve the local capacity (including in remote or rural communities) in the host country to address biorisks and threats that could affect U.S. national security. Furthermore, by establishing and maintaining relationships with individuals, institutions, and networks, BTRP contributes to the security of the United States through both communication and action. However, the advances in biotechnology and its potential misuse discussed in this report, and vastly enhanced modes of communication and information transfer that reduces the timelines for interventions to reduce risks, warrants a review and refreshment of the vision for BTRP and its ability to meet its mission. This final chapter presents the committee’s findings (numbered in relation to the recommendation they support) derived from a review of the past 20 years of engagements by BTRP. The findings lead to seven recommendations intended to position BTRP to adapt to new realities, to sharpen its focus, and to have the greatest positive impact on reducing threats and risks to deployed U.S. military forces, U.S. interests overseas, and the homeland over the next 5 years and beyond. The recommendations fall into three broad categories: (1) Authorities and Responsibilities; (2) BTRP In-Country Engagement; and (3) Connecting BTRP with Others on Biological Threat Reduction.
A Congressional Determination Authorizing BTRP Engagement Globally
Going forward, BTRP must be further empowered to anticipate where it should prioritize building connections and support partner-country efforts to prevent malicious use of biology, and to address emerging threats from infectious diseases, whatever their source. To pursue this, BTRP needs to be supported by having sufficient flexibility and to be able to act quickly, under the authority from DOD, to implement its scope of responsibilities and actions.
FINDING 1.1: The emergence and dissemination of pathogens as reservoir and vector hosts spread into new geographic areas, as well as through movement of humans, international travel, and trade in potentially infected animals, plants, and animal and plant products can cause disease outbreaks in geographically distinct regions and countries with no prior knowledge of or experience with the agent, exposing susceptible humans, animals, or plants, providing opportunities for health risks, economic disruption, and destabilization, and increasing the risk of local outbreaks.
FINDING 1.2: BTRP is constrained by both political and geographic requirements that inhibit its ability to respond nimbly to emergent threats. As a result, BTRP is unable to keep pace with the speed at which science and technology are changing the biological risk landscape, reducing its ability to preclude or mitigate potential threats as they emerge.
FINDING 1.3: At its best, BTRP activities improve facilities, procedures, and practices and establish strong, trusted relationships with laboratories and laboratory personnel in complex political and technical settings around the world, and by doing so provide unique functions for improved local and U.S. national security. BTRP needs greater flexibility in its geographic and programmatic operations such that it can truly function at its best.
FINDING 1.4: Natural, accidental, and intentionally caused outbreaks can have similar consequences for health, the economy, and national security. Despite the initial cause of the outbreak, they also have similar requirements related to common prevention, detection, response, and recovery initiatives. There are advantages to addressing these events as different manifestations of the same family of challenges. An integrated view of biological threats prevents bureaucratic boundaries from interfering with partnerships and progress. Natural, accidental, and intentional outbreaks may have ambiguous origins but the capabilities needed to address them overlap. Ultimately, needs of force protection and national health and safety may be similar in most cases, especially those with the broadest potential national security impact.
RECOMMENDATION 1: The Office of the Secretary of Defense for Policy should seek a global determination from Congress, which would give BTRP authority and flexibility to work when and where national biosecurity needs–and diplomatic opportunities–are identified or reasonably anticipated.
Mission and Engagement Flexibility
Knowledge and understanding of local partner capabilities in several key areas are essential to guiding biological threat reduction investments, including: (1) the ability to conduct ongoing disease surveillance, which entails identifying and reporting potential outbreaks at the earliest opportunity; (2) the ability to understand security concerns; (3) the ability to engage governments and civil society; (4) the ability to detect and address intentional threats to biosecurity; and (5) the ability to secure repositories of microbial agents and patient samples.
FINDING 2.1: The development of threat-specific prevention and detection approaches can be improved through anticipation of current and future threats presented by natural, accidental, and intentional incidents involving high-consequence pathogens and toxins and by misuse of
advances in scientific research, development, and application.
FINDING 2.2: New scientific advances, including multi-use technologies, methods, and information highlight the need for more robust approaches for analyzing the anticipated and unanticipated consequences of scientific efforts, including misuse, reducing potential risks, and reaping the scientific benefits for prevention and detection of biological risks.
FINDING 2.3: Facilities and information systems using cybersecurity and data security approaches are vulnerable to exploitation by malicious actors who could access, monitor, steal, or manipulate data and analytic results remotely and without notice, or disrupt the flow of data to scientific partners. Cyber-related threats now include threats to facilities and information systems, harmful use of genomics and advanced data analytics, and the development of new biological systems.
RECOMMENDATION 2: DTRA should give BTRP as much programmatic flexibility as possible to understand and broadly address the current and anticipated biosecurity and biosafety needs of each country where it engages. The needs may be underlying biosecurity challenges, so the actions may be one step removed from traditional activities, such as building in-country and regional networks, organizing focused scientific meetings, and developing emerging leaders.
Personal Relationships Are Key to Successful Engagements
Engagements in collaborative biological threat reduction programs are first and foremost about humans. Science, health issues, technologies, procedures, and research on pathogens are tools for good, or sometimes for harm. It is critically important to recognize that to develop and maintain successful personal engagements, BTRP must listen more than it
directs, and deliver whatever commitments are made. Central to the mission goals–even if not fully attainable–is to develop trusted relationships between BTRP and its partners in the host country. As noted in Chapter 5, open dialogue among equals builds understanding and trust between technical experts, which over the long term contributes further to trust and understanding among leaders in ministries and governments. Where trust exists, transparency increases, rendering those areas less hospitable for sub-state groups or individuals with ill intent. Professionals working on cooperative programs need technical, interpersonal, and diplomatic competencies.
FINDING 3.1: Successful programs match people from the two partner countries who have the necessary technical and diplomatic skills, and the willingness to develop relationships of trust through working together toward common goals. These interpersonal relationships form the resilient core of the larger institutional relationships.
RECOMMENDATION 3: BTRP should select technical engagement professionals to represent the U.S. government in these important engagements with consideration of their communication, interpersonal, and diplomatic skills and, as necessary, provide training in diplomacy and on the political contexts in which they work to supplement their necessary science backgrounds.
Assessment and Planning Prior to Engagement
BTRP resources are relatively small in comparison with other DOD programs and have been shrinking in recent years. In this context BTRP should not engage an international partner just because it can. The transportation, communication, and computational revolutions have provided an enhanced capacity to identify hot spots for emerging new risks and threats with a greater degree of accuracy than ever before. As explained below, BTRP should take an even more strategic view and carefully articulate why it must engage, where it must engage, and with what resources, including the necessary human resources, it must engage.
FINDING 4.1: The International Health Regulations (2005) require all countries to achieve minimum core competency to detect, assess, report, and respond to public health, plant,
and animal health risks and emergencies of national and international concern. Not all countries have met these requirements, in significant part because of inadequate resources to implement assessment and capacity strengthening support at the country level.
FINDING 4.2: Sample and data sharing are critical to early detection of transboundary outbreaks, but access to this information may be limited because of strict sample and data-sharing policies in partner countries. Delays in data access could delay reporting to international health organizations, alerting neighboring countries to the potential threat, and initiating emergency response activities in a timely manner, including development of field ready diagnostic tests, and planning of clinical trials of countermeasures, including therapeutics and vaccines.
FINDING 4.3: Methods for engineering and synthesizing viruses and bacteria are being democratized, enabling easier access to pathogens created or modified from gene sequence data. Although the skills, knowledge, and human and financial resources needed to create or modify live pathogens from chemical synthesis, reverse genetics, or genome editing are specialized and high, their use may be possible by scientists from nation states and well-resourced non-state actors intent on using microbial pathogens for malicious purposes.
FINDING 4.4: Measuring threat reduction from engagement programs is difficult. Common quantitative metrics are ineffective. The program needs to continue to develop and try out new approaches, such as the use of a quasi-qualitative rubric for measuring achievement of individual activities and overall goals of projects, country portfolios, and program initiatives. Such non-traditional measurements provide opportunities to course-correct when hurdles are encountered, support conditions and factors that facilitate achievement of goals, and promote partner country buy-in and sustainability of capabilities. This approach to metrics can help to demonstrate accountability, and provide greater awareness of program results and context of
engagement, to DOD senior leaders, Congress, and other relevant stakeholders.
RECOMMENDATION 4: The Office of the Secretary of Defense for Policy together with BTRP should monitor and identify likely future potential infectious disease vulnerabilities in the changing threat landscape. As a part of this forward assessment process, BTRP should identify opportunities to bolster local partner countries’ capabilities to detect aberrations from the norm early in an event or outbreak in order to better anticipate events through improved disease surveillance and better analytical capacity.
Build and Leverage Networks
It is as clear that BTRP cannot address every biological threat as it is axiomatic that funds should be used in a manner that can efficiently produce the best outcomes. Not only is this the right thing to do, it is also the way to strengthen BTRP programs by building sound working relationships with other agencies of the U.S. government, international partners, nongovernmental organizations, academic institutions, and private companies that appropriately take the lead in many circumstances. By leveraging these relationships more effectively, BTRP can be better attuned to the threats, risks, and opportunities in the field. Because these threats and risks are so diverse and address a wide range of partners, BTRP should coordinate with partners who focus not only on human health, but also on animal and plant health, the safety and security of food systems; trade and travel routes; and the social, political, and economic factors that affect these elements of biosafety and biosecurity.
FINDING 5.1: Outbreaks of animal and plant pathogens that adversely affect the agricultural system and food industry can directly or indirectly impact human health, and have the potential to lead to destabilization of societies and economies, and/or national and regional conflicts.
FINDING 5.2: The inextricable links among human, animal, plant, and environmental health highlight the risk of natural or human-made pathogens in the food system, along trade and travel routes, and through changes in the environment. Each of these factors can either severely affect production of major plant food crops and meat products, or promote the appearance and spread of new potentially zoonotic infectious disease threats to humans in addition to their impacts on the affected animal populations. These risks could result in significant health, social, political, and economic consequences leading directly to political and civil unrest–especially in countries with pre-existing marginal or unstable governmental systems and weak infrastructure.
FINDING 5.3: Inadequate provision for fundamental needs, such as food and clean water, enables transmission of environmental pathogens into the human population and increases opportunities for conflict, which present a different type of security risk.
FINDING 5.4: Navigating the diverse landscape of international experts, implementing organizations, coordinating organizations, and funders can be difficult given the sheer number of entities involved. To be most effective, any actor engaging in these efforts–including BTRP–must leverage existing capabilities, cooperate with other funders regardless of any difference in mission, and promote deconfliction of activities in countries where human and financial resources are limited. To obtain the most information and understand the necessary response, these actors also need to coordinate with one another and to communicate and share information for the immediate public health needs and for generating research data for the future.
RECOMMENDATION 5: BTRP should focus more attention and emphasis on linking experts inside and outside of BTRP, including leaders in partner countries, into regional and global networks to further BTRP’s mission goals and enhance its awareness of technical and epidemiological developments. These
include extant threats to political, social, and economic stability and long-term partner government sustainability in the context of outbreaks of emerging infectious diseases in humans, food animals, or crops in order to improve biosecurity broadly in vulnerable and at-risk partner countries.
Bolster Internal Expertise and Seek Advice
BTRP is inherently an action-oriented organization within DOD designed to reduce the risk of biological threats, and therefore BTRP staff require pragmatic political skills in addition to contemporary understanding of the nature of these biological threats, whatever their origin. In conjunction with the need for additional scientific expertise affiliated with the Cooperative Threat Reduction (CTR) Program, and participation in relevant scientific and biosecurity meetings, BTRP would benefit from access to an external broad-based group of experts, including those who can consider traditional and emerging biological threats that may arise from new research strategies and tools. These advisory groups have long served the military, beginning during World War II and continuing from 1953 as the Armed Forces Epidemiological Board. During the early days of the Nunn-Lugar CTR Program in the former Soviet Union, a small, senior advisory group was used very effectively by the Defense Threat Reduction Agency (DTRA), not only to enhance understanding of the scientific issues underlying threat reduction and to assist with project reviews but, importantly, to advocate for the CTR Program. In these times of cutbacks and a dearth of advocates in Congress, a group of senior experts with relevant experience to advise BTRP could add a robust scientific foundation for BTRP’s efforts and help to make the case for its programs for the foreseeable future.
FINDING 6.1: Preparing for and responding to existing and potential biosecurity threats requires an agile ability to consider traditional biological threats and the contributions of new research strategies and tools to understand the pathogenesis and epidemic potential of emerging pathogens.
FINDING 6.2: The biological sciences and biotechnology are advancing at a pace that far exceeds current security assessments. Although the future is always hard to predict, the potential for DOD to anticipate current and future
capabilities and uses cannot be based on current scientific and technological activities alone, but rather must be amplified by accessing insights into where that science is going, what is the leading edge, and what are the hot topics and breakthrough achievements. This requires a sufficient and critical mass of well-trained scientists from diverse fields within the agency. The ability of these scientists to contribute fully will be strengthened by participation in high-level scientific conferences, reading of relevant publications, and networking with academia and leading biotechnology companies. They could also benefit from engagement with a high-level external scientific advisory group composed of experts in diverse scientific disciplines, particularly individuals with relevant international experience.
RECOMMENDATION 6: BTRP should acquire greater scientific expertise on its staff and proactively engage with the broader scientific community to better understand technical and scientific developments in emerging infectious diseases. This engagement can be accomplished by some combination of participating in important scientific meetings, contracting with scientific organizations, establishing a scientific advisory group, and/or working with individual experts. The goal is to access expertise and experience working internationally on topics of biosafety and biosecurity, epidemiology, disease surveillance, security, biotechnology, industry, and related topics. These efforts will strengthen BTRP’s ability to meet its responsibilities and obligations, and enhance its effectiveness.
Network within DOD and U.S. Government Agencies
The surprise outbreak of Ebola in West Africa and its rapid spread regionally and sporadic cases arriving in a number of other countries in Europe and North America has clearly sent the message that we must engage, communicate, and plan more effectively within DOD and DTRA, as well as with other departments, agencies, and initiatives of the U.S. government. BTRP must be seen and recognized as playing an important and unique role, not only to anticipate future biothreats and support
capacity strengthening, but also to rapidly mobilize and coordinate support for the immediate response to an infectious disease outbreak or an incident caused by intentional misuse. As a result of its role, BTRP should be included in critical discussions and coordination meetings.
FINDING 7.1: Within DOD, BTRP plays a critical role in advancing national biosecurity interests internationally.
FINDING 7.2: Because BTRP is just one of several U.S. government programs conducting health security engagement, both the strategic vision and success of biosecurity programs rely on actions by the U.S. government as a whole, host governments, and international partners.
FINDING 7.3: Using the integrated view of biological threats and threat reduction, the U.S. government will be most effective and efficient if it identifies and prioritizes the threats and applies resources to those threats through the departments, organizations, offices, and channels that are best poised to address the associated needs. These channels are the various medical, military, diplomatic, humanitarian, scientific, and security programs of the U.S. government and its partners at home and internationally, which are able to intervene in different ways and in different contexts to eliminate, reduce, or mitigate threats at the most opportune and effective stage of threat development. Strong interagency coordination must drive these prioritization and resource allocation efforts if the needs are to be addressed and unnecessary duplication of efforts and costs are to be avoided.
RECOMMENDATION 7a: BTRP should establish closer working relationships with the combatant commands, Army Futures Command, Assistant Secretary of Defense for Special Operations/Low-Intensity Conflict, and the Office of the Assistant Secretary of Defense for Health Affairs for coordination and prioritization of limited resources, and the service laboratories as well as relevant interagency partners such as the Centers for Disease Control and Prevention and the National Institutes of Health, sharing its unique capabilities and insights
about biothreats. Through effective synchronization, these entities can assist one another to more effectively protect the force and the nation.
RECOMMENDATION 7b: Over the next 5 years, BTRP, working with its many DOD partners, should encourage, engage, support, co-lead, and help drive the U.S. government’s development of a durable interagency mechanism that draws on medical, military, diplomatic, scientific, and other expertise to address natural, accidental, and intentional biological threats and risks to the deployed force and to the nation. An effective interagency mechanism will avoid unnecessary duplication, identify and close gaps, and explore possible synergies. Likewise, it will allow for greater geographic flexibility, more effective communication links, and will demonstrate better awareness and prevention of threat development, and more timely response. To enhance overall coordination, BTRP should partner effectively within DOD, with other U.S. government agencies, with other nations, as well as with NGOs, the private sector, and academia.