A STRATEGIC VISION FOR
BIOLOGICAL THREAT REDUCTION

THE U.S. DEPARTMENT OF DEFENSE
AND BEYOND

Committee on Enhancing Global Health Security through
International Biosecurity and Health Engagement Programs

Committee on International Security and Arms Control

Policy and Global Affairs

A Consensus Study Report of

THE NATIONAL ACADEMIES PRESS
Washington, DC
www.nap.edu

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This activity was supported by contract number 10003553 between the Department of Defense/Defense Threat Reduction Agency and the National Academies of Sciences, Engineering, and Medicine. Any opinions, findings, conclusions, or recommendations expressed in this publication do not necessarily reflect the views of any organization or agency that provided support for the project.

International Standard Book Number-13: 978-0-309-67182-8
International Standard Book Number-10: 0-309-67182-5
Digital Object Identifier: https://doi.org/10.17226/25681
Library of Congress Control Number: 2020934594

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Suggested citation: National Academies of Sciences, Engineering, and Medicine. 2020. A Strategic Vision for Biological Threat Reduction: The U.S. Department of Defense and Beyond. Washington DC: The National Academies Press. https://doi.org/10.17226/25681.

Committee on Enhancing Global Health Security through International Biosecurity and Health Engagement Programs

David R. Franz, (co-chair from April 2019), Independent Consultant, Gettysburg, PA

Gerald T. Keusch, (NAM¹) (co-chair from April 2019) Boston University, Boston, MA

Ronald M. Atlas, (chair until April 2019) University of Louisville, Louisville, KY

Nisreen D. Al-Hmoud, Royal Scientific Society of Jordan, Amman, Jordan

David M. Barash, GE Foundation, Boston, MA

Kavita M. Berger, Gryphon Scientific, Inc., Takoma Park, MD

Kenneth W. Bernard, Independent Consultant, Monterey, CA

Gregory C. Gray, Duke University Medical Center, Durham, NC

John E. Lange, The United Nations Foundation, Washington, DC

Mobolaji O. Odubanjo, The Nigerian Academy of Science, Akoka-Yaba, Lagos State, Nigeria

Study Staff

Rita S. Guenther, Study Director, Committee on International Security and Arms Control (CISAC)

Micah Lowenthal, Director, CISAC

Jo Husbands, Scholar/Senior Project Director, Board on Life Sciences (BLS)

Audrey Thevenon, Program Officer, BLS

Nicole Cervenka, Research Associate, CISAC (from December 2018)

Hope Hare, Administrative Coordinator, CISAC

Joanna Roberts, Research Associate, CISAC (until November 2018)

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¹ National Academy of Medicine member.

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Preface

The Biological Threat Reduction Program (BTRP), part of the U.S. Department of Defense (DOD), today is a product of bold and innovative thinking in the early 1990s by Senators Sam Nunn and Richard Lugar, and a cadre of practical academic thinkers. The broader framework they established, the Cooperative Threat Reduction (CTR) Program, was conceived as a valuable tool to address a particular set of challenges associated with the dissolution of the Soviet Union. The program has since evolved and transformed in scope and mission, engaging more widely in other parts of the globe beyond the former Soviet Union to prevent the proliferation or use of weapons of mass destruction, including by enhancing biosecurity and disease outbreak identification. More recently, the CTR Program has once again focused concern on state-level threats. Throughout the lifetime of the program thus far, biosecurity incidents, both in the United States and abroad, have occurred much less frequently than either biosafety incidents or naturally occurring disease events. But technology, connectivity, and the erosion of norms against the use of unconventional weapons all contribute to making these biological risks and threats ever more complex and the timelines to address them shorter.

Our study committee was asked to recommend a new strategic vision for health security in a setting of rapid changes in biotechnology and geopolitics, by considering which forms of engagement have been successful, what else is needed, and how future work may be more effective. In short, how should BTRP engage partners in the United States and around the world to help make the world safer for the U.S. military forces, for the United States, and thus for other countries; that is, safe from intentional misuse of biological materials, laboratory accidents, natural outbreaks, and technical surprise?

The Committee on Enhancing Global Health Security through International Biosecurity and Health Engagement Programs wrestled with how to advise BTRP with a strategic vision when an effective strategy must include other parts of the U.S. government and, for that matter, other governments and organizations in the United States and abroad. Furthermore, we, the co-chairs, are from distinct professional backgrounds (Keusch from global health and Franz from the military) representing a

broad range of tensions between distinct communities, each of which emphasizes different parts of the same problem set often called global health security. These communities sometimes draw conceptual mission boundaries based on the origin of a threat (accidental, natural, or intentional), which enables them to limit the scope of their work so that while the two may overlap, mission conflict is minimized. This made the study process challenging but ultimately resulted in a stronger report. We see this as a metaphor for BTRP itself. CTR is about building human relationships and capabilities, and opening lines of communication—primarily in the health and research sectors—to reduce risks and threats across the biological space. Public health engagement has also historically reduced threats, but typically not as its first priority, which is to improve health.

To the uniformed military and DOD, it is essential to recognize that the work of BTRP and CTR more broadly is a defense mission, and it requires coordination. Guidance from the White House and from the Secretary of Defense reaffirm the need for coordination within the U.S. government and for partnerships outside of it—coordination is easy to speak about but hard to deliver. Whether for protection of deployed U.S. military forces and U.S. interests overseas, or for protection of the homeland, DOD will only be fulfilling this aspect of its mission if it works with partners to anticipate, prevent, detect, respond to, and recover from biological risks and threats, whatever their origin. We may not know whether an outbreak is a result of intentional, accidental, or natural events during the timeframe in which action must be taken. And DOD needs to recognize that BTRP, if given sufficient flexibility to identify and develop programs on emerging risks, can strengthen each action taken to counter threats and mitigate risks. But it is even more complicated, as the current and ongoing Ebola outbreak in northeastern Democratic Republic of the Congo demonstrates. Like this one, future outbreaks may occur in unstable areas where armed civilian and ideological militias willing to engage in violence against healthcare workers, both domestic and international, where citizen distrust of government and the international community is equally dispensed, and where there may be no support for a foreign military or civilian effort to engage and deliver much-needed infrastructure, diagnostics, therapeutics, vaccines, and other support. BTRP should be strategically suited to systematically build the relationships and community engagement ultimately necessary for acceptance in the country.

For the public health sector, it is essential to recognize that DOD has enormous resources and capabilities, medical and logistical, to prevent and respond to emerging infectious disease. Its logistical reach alone is unmatched, but it can also engage more easily with some governments. In places, public health organizations will be the most effective partner to engage internationally, but in others it will be the military that can provide the entrée. By working within an effective interagency mechanism, BTRP can serve as a bridge between these communities and facilitate their cooperative efforts globally.

In this report, we describe the history of CTR and BTRP as well as the dynamic technological and geopolitical worlds of today so that the reader can better understand what needs to change and where BTRP must go. The middle chapters examine context and cases to illustrate what has been effective, where there are gaps and shortcomings, and what new obstacles might block the way to further success. The committee offers recommendations that we believe will significantly enhance the impact and efficiency of BTRP for the next 5 years and beyond. We conclude that global engagements resulting from relationships of respect and trust between and among professionals are needed—indeed, it may be needed now as much as or more than at any previous time—that BTRP is an essential component of the nation’s options for addressing current and future needs, that there are potential improvements to how it is implemented, and that it remains one of the most cost-effective arrows in the quiver of DOD and the U.S. government.

Gerald T. Keusch and David R. Franz, co-chairs
Committee on Enhancing Global Health Security through
International Biosecurity and Health Engagement Programs

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Acknowledgment of Reviewers

This Consensus Study Report was reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise. The purpose of this independent review is to provide candid and critical comments that will assist the National Academies of Sciences, Engineering, and Medicine in making each published report as sound as possible and to ensure that it meets the institutional standards for quality, objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the deliberative process.

We thank the following individuals for their review of this report: Ekanem Braide, Federal University of Lafia; Seth Carus, National Defense University; Diane DiEuliis, National Defense University; Jeanne Fair, Los Alamos National Laboratory; Asha George, Bipartisan Commission on Biodefense; Elizabeth George, Environmental Protection Agency; Diane Griffin, Johns Hopkins University; Aamer Ikram, National Institute of Health Pakistan; Bonnie Jenkins, Women of Color Advancing Peace, Security and Conflict Transformation; Kent Kester, Sanofi Pasteur; Margaret Kosal, Georgia Institute of Technology; Clifford Samuel, Gilead Sciences, Inc.; Christine Uhlenhaut, World Organisation for Animal Health; and Pavlos Vlachos, Purdue University.

Although the reviewers listed above provided many constructive comments and suggestions, they were not asked to endorse the conclusions or recommendations of this report nor did they see the final draft before its release. The review of this report was overseen by Gail Cassell, Harvard University, and Nancy Connell, Johns Hopkins University. They were responsible for making certain that an independent examination of this report was carried out in accordance with the standards of the National Academies and that all review comments were carefully considered. Responsibility for the final content rests entirely with the authoring committee and the National Academies.

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Contents

ACRONYMS

EXECUTIVE SUMMARY

IN REMEMBRANCE

SUMMARY

Ambiguities and Functional Similarities Make Natural, Accidental, and Intentional Threats Different Manifestations of the Same Family of Challenges

A Diverse Team of Organizations is Needed to Address the Complex Threat Landscape

The Need to Anticipate, Detect, and Respond Rapidly to Threats

The Need for Geographic and Programmatic Flexibility

The Importance of Recruiting and Retaining the Most Effective BTRP Professionals

The Importance of Broader Awareness about BTRP’s Experience and Expertise

The Strategic Vision for BTRP

1 THE HISTORY OF COOPERATIVE THREAT REDUCTION (1991-2018)

Key Messages and Study Background

Overview of the Evolution of Cooperative Threat Reduction

The Origins of the Biological Threat Reduction Program: CTR 1.0

Taking Stock of the First 15 Years, and Planning Ahead to Biological Cooperative Threat Reduction: CTR 2.0

The Current Reality: BTRP Poised for CTR 3.0

2 THE CHANGING BIOTHREAT LANDSCAPE

Key Messages

Global Health Security

International Health Security Partners

Data Sharing Relevant to Global Health Security

Security and Defense of Agriculture and Food Supplies

Travel and Trade

Laboratory Synthesis of Pathogens

Emerging Biotechnology

Data Security

Policy Framework for BTRP Planning and Investment

Metrics and Evaluation for Biological Threat Reduction Programs

3 ADDRESSING BIOTHREATS THROUGH SUCCESSFUL ENGAGEMENT

Key Messages

Benefits of Scientific Engagement to Biothreat Reduction

One Health

Trusted Relationships are Critical to Success

Learning from Disparate Experience

4 KEY ROLES FOR THE DEPARTMENT OF DEFENSE IN BIOLOGICAL THREAT REDUCTION

Key Messages

U.S. Interests Abroad

Support to and Coordination With DOD and Beyond

5 STRATEGIC VISION AND THE WAY FORWARD

Current Approaches of the Biological Threat Reduction Program

The Strategic Vision for BTRP

6 KEY FINDINGS AND RECOMMENDATIONS

Authorities and Responsibilities

BTRP In-Country Engagement

Connecting BTRP With Others on Biological Threat Reduction

REFERENCES

A COMMITTEE BIOGRAPHIES

B CONGRESSIONALLY-APPROPRIATED FUNDING FOR THE BIOLOGICAL THREAT REDUCTION PROGRAM (2007-2020)

C U.S. AND INTERNATIONAL AGENCIES AND ORGANIZATIONS ENGAGED IN GLOBAL HEALTH SECURITY

U.S. Government Agencies

International Governmental Efforts

U.S. Organizations and Implementors

International and Regional Organizations

Acronyms

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Executive Summary

The Committee on Enhancing Global Health Security through International Biosecurity and Health Engagement Programs was asked to articulate a 5-year strategic vision for international health security programs and provide findings and recommendations on how to optimize the impact of the Department of Defense (DOD) Biological Threat Reduction Program (BTRP) in fulfilling its biosafety and biosecurity mission. Because BTRP is just one of several U.S. government programs conducting international health security engagement, both the strategic vision and the success of the program rely on coordinating actions with the U.S. government as a whole and with its international partners.

Ongoing revolutions in the life sciences, ease of access to information, rapid transportation of people, and widespread trade in animals and plants all point toward novel threats from new actors, shorter timelines, and less geographic protection. As a result, there are greater risks now than ever before to deployed U.S. military forces, U.S. interests overseas, and to the homeland. International engagement is one of the most cost-effective tools available to prevent adverse events rather than to respond to them after they occur. BTRP’s engagements are a critical component of DOD’s mission to protect the United States’ national security by reducing the likelihood that a natural, accidental, or intentional outbreak from outside of the United States will cause significant harm to the United States or its allies and interests. BTRP should be given as much geographic and programmatic flexibility as possible to understand and address broadly the biosafety and biosecurity needs of its partner nations as the program serves U.S. interests. Mutually beneficial programs increase the likelihood of adoption and sustained ownership by partners, and if the program builds trusted relationships then communication with U.S. partners may continue even after DOD funding ends.

There are advantages to addressing natural, accidental, and intentional incidents or outbreaks as different manifestations of the same family of challenges. They may have ambiguous origins but the capabilities needed to address them overlap. An integrated view of biological threats also prevents bureaucratic boundaries from interfering with partnerships and progress. Furthermore, the overall mission encompasses anticipation, deterrence, prevention, detection, response, mitigation, and recovery.

Action or intervention is possible at every stage and different components of the U.S. government effort (DOD, Department of State, U.S. Agency for International Development, Centers for Disease Control and Prevention (CDC), and others) have advantages in one or another part of the mission or in different partner countries, and so may be better able to intervene and eliminate, reduce, or mitigate risks at the most opportune and effective stage of development in different contexts. The U.S. government will be most effective and efficient if it identifies and prioritizes the threats it wishes to counter and applies resources through the channels that are best poised to address the associated needs. Strong interagency coordination must drive these prioritization and resource-allocation efforts if the needs are to be effectively addressed.

No U.S. government program currently has or should be expected to have the authority or the capability to act on every aspect of the challenge of global health security. To address that challenge, BTRP and other agencies need to be part of a durable interagency coordination mechanism that addresses the full set of biological threats and risks, wherein the agencies best suited to each task are given the necessary tools. An effective mechanism will provide BTRP with greater geographic and programmatic flexibility, will allow BTRP to demonstrate better awareness, prevention of threat development, and more timely response, and will enhance BTRP’s ability to partner effectively within DOD, with other U.S. government agencies, with other nations, as well as with nongovernmental organizations (NGOs), the private sector, and academia.

In this report, the committee (See Appendix A for committee member biographies) provides several recommendations for optimizing BTRP success in its current mission and the wider-looking strategic vision proposed by the committee.

A 5-YEAR VISION

In the next 5 years, BTRP, working with its many DOD partners, should encourage, engage, support, and co-lead the U.S. government’s development of a durable interagency mechanism to address the full set of biological threats and risks to deployed U.S. military forces, U.S. interests overseas, and to the homeland. This mechanism should seek to intervene and eliminate, reduce, or mitigate risks at the most opportune and effective stage of development and identify the agency or agencies best suited to engage and advance the mission. An effective interagency mechanism will

provide for: (1) greater geographic flexibility; (2) demonstrably better awareness and prevention of threat development; (3) more timely response; and (4) effective partnerships within DOD, with other U.S. government agencies, with other nations, as well as NGOs, the private sector, and academia. Likewise, an effective interagency mechanism will avoid unnecessary duplication, identify and close gaps, and explore possible synergies.

Embrace an Integrated View of Biological Threats

There are advantages to addressing natural, accidental, and intentional incidents or outbreaks as different manifestations of the same family of challenges. They have functional similarities and common prevention, detection, response, and recovery initiatives. They 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 or the same in virtually all cases. An integrated view of biological threats prevents bureaucratic boundaries from interfering with partnerships and progress.

Identify Needs and Opportunities

Effective disease surveillance extends beyond detection of disease outbreaks to noting and responding to the conditions that feed and lead to infectious disease risks and threats. Such risks include inadequate domestic diagnostic laboratory infrastructure or poor domestic disease surveillance and public health capabilities, and inadequate subject-matter expertise to prevent and respond to infectious diseases. Effective disease surveillance must also be paired with input and analysis from the security sector and analysis to evaluate opportunities to intervene.

Select International Partners

Foreign governments (hosts and non-hosts), NGOs, the private sector, academia, international organizations, and networks including the Global Health Security Agenda and the Global Partnership Against the Spread of Weapons and Materials of Mass Destruction provide both resource synergies and information networks vital to preparedness and early warning.

Select Partners in the United States

To enhance efficiencies and leverage scarce human and physical resources, BTRP should draw broadly on CDC, DOD, Department of State, Federal Bureau of Investigation, Department of Health and Human Services, Department of Agriculture, NGOs, private sector, academic partners, and subject-matter experts.

Strengthen Relationships and Build Networks Within the Department of Defense

BTRP must establish working relationships within DOD before they are needed. Particularly, regular open and frank communication must be ongoing between BTRP and combatant commands, Office of the Assistant Secretary of Defense for Special Operations/Low-Intensity Conflict Division, Office of the Assistant Secretary of Defense for Health Affairs, the Office of the Secretary of Defense for Policy, and other relevant DOD partners.

Evaluate and Refine

BTRP should regularly evaluate progress and refine its approaches. It should add or subtract partners, create new networks, and share lessons learned and best practices. It should support and value human relationships between experts within the relevant scientific, technical, and health sectors and thoughtfully terminate unproductive partnerships.

In Remembrance

Dr. David Hamburg, 1925-2019
Senator Richard Lugar, 1932-2019

In April 2019 as this National Academies of Sciences, Engineering, and Medicine committee deliberated about the future of the Biological Threat Reduction Program, Dr. David Hamburg and Senator Richard Lugar, two of the architects of the Cooperative Threat Reduction (CTR) Program, passed away. They were among a select group of individuals who, after the dissolution of the Soviet Union in 1991, sought to address the enormous proliferation threats posed by unemployed scientists and unsecured offensive nuclear and chemical weapons, and later, biological weapons (Ford, C., 2016). Informed by years of scholarship on nuclear security and U.S.–Russia relations—such as the International Peace and Security Program established in 1983 by Dr. Hamburg during his time as President of the Carnegie Corporation of New York—security and foreign policy experts saw a clear need to address a significant emerging nonproliferation challenge. This nonproliferation program laid the foundation for CTR, specifically by supporting the Prevention of Proliferation Task Force that produced the seminal report, Soviet Nuclear Fission: Control of the Nuclear Arsenal in a Disintegrating Soviet Union (Campbell, 1991), that ultimately led to the development of the Soviet Nuclear Threat Reduction Act of 1991¹ which was co-sponsored by Senator Lugar and Senator Sam Nunn (Rosenberg, 2004). Three years later, in 1994, the CTR Program evolved to include the former Soviet biological weapons program and a decade later global biological threats and risks more broadly, and evolved to focus on reducing threats through partner-country capability building. The reduction of biological threats via the CTR Program has continued ever since, and now engages partners beyond the originally authorized geographic areas of the former Soviet Union.

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¹ Soviet Nuclear Threat Reduction Act of 1991, Pub. L. No. 102-228 (1991).

Along with other eminent figures such as Senator Nunn and Secretary of Defense Ashton B. Carter, Dr. Hamburg’s and Senator Lugar’s vision and leadership in reducing nuclear, chemical, and biological proliferation threats will be felt for years to come as the world grapples with both old and new threats from state-level programs, naturally occurring and accidentally released pathogens, and scientific and technological advances that exacerbate existing risks and/or present new risks.

This committee is honored to contribute to continuing the efforts initiated by Dr. Hamburg, Senator Lugar, and their partners in ensuring a world secure from harms caused by biological agents and malevolent exploitation of peaceful research.