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Introduction

The US Department of Defense (DoD) has a long history in the area of chemical and biological defense (CBD). Over the course of that history, the program has evolved to address a broad spectrum of threats that would not and could not have been envisioned in the beginning. A critical part of the endeavor of DoD has been to engage smart and talented individuals to perform work in this area. The work has evolved over the years to what it is today. The program is at a turning point in terms of how it is able to implement its research, development, test, and evaluation (RDT&E) efforts to support the mission of the department.

To that end, the National Research Council was asked by the Office of the Assistant Secretary of Defense for Nuclear, Chemical, and Biological Defense to form an ad hoc committee that is able to address the current state of the enterprise and provide input into framing the program’s efforts as it moves forward.

STATEMENT OF TASK AND PURPOSE OF STUDY

Statement of Task

This study was carried out in response to the following statement of task:

The National Research Council (NRC) of the National Academy of Sciences (NAS) will identify the scientific and technology capabilities that must be available to support Chemical and Biological Defense Program



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1 Introduction The US Department of Defense (DoD) has a long history in the area of chemical and biological defense (CBD). Over the course of that history, the program has evolved to address a broad spectrum of threats that would not and could not have been envisioned in the beginning. A critical part of the endeavor of DoD has been to engage smart and talented individuals to perform work in this area. The work has evolved over the years to what it is today. The program is at a turning point in terms of how it is able to implement its research, development, test, and evaluation (RDT&E) efforts to support the mission of the department. To that end, the National Research Council was asked by the Office of the Assistant Secretary of Defense for Nuclear, Chemical, and Biological Defense to form an ad hoc committee that is able to address the current state of the enterprise and provide input into framing the program's efforts as it moves forward. STATEMENT OF TASK AND PURPOSE OF STUDY Statement of Task This study was carried out in response to the following statement of task: The National Research Council (NRC) of the National Academy of Sci- ences (NAS) will identify the scientific and technology capabilities that must be available to support Chemical and Biological Defense Program 13

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14 CORE CAPABILITIES IN CHEMICAL AND BIOLOGICAL DEFENSE (CBDP) research, development, test and evaluation, and operational ac- tivities, and provide guidance on which of these capabilities can be obtained outside the Military Service laboratories, which are unavail- able except in the Military Service laboratories, and which are so mis- sion-critical (classified, non-proliferation, or other) that they should be maintained in the Military Service laboratories. It will review relevant Department of Defense (DoD) studies and other pertinent literature, and conduct site visits and interviews with all necessary CBDP and DoD Laboratory stakeholders to collect the data to accomplish the study objectives. It will provide guidance for coordination and development of consensus within the CBDP community with a view toward maximizing acceptance and ownership of these requirements and definitions. Purpose of the Study This study was requested by the Deputy Assistant Secretary of Defense for Chemical and Biological Defense (DASD(CBD))1 to assist in several objectives. The committee considered the following objectives as they approached their charge: 1.Defining the terms "core scientific and technology capabilities neces- sary for conducting core CBDP RDT&E activities" that is acceptable to all DoD CBDP and Laboratory stakeholders. Define how DoD sustains core capabilities, accounting for DoD sustainment guidance, resources, and authorities. 2.Identifying the scientific and technology capabilities DoD requires to accomplish the CBDP mission based on the known and anticipated threats and state of the Science and Technology (S&T) base between now and 2025. 3.Identifying which of these capabilities DoD should consider "core," and recommend core capacity levels at which DoD should seek to sustain core capabilities. 4.Identifying options and needed resources for preserving these ca- pabilities for DASD(CBD) consideration. This includes identifying the current model for sustaining lab infrastructure within DoD and determining if this is the most effective method for maintaining DoD critical infrastructure. The committee was advised that this report is intended to be used in developing the POM (Program Objective Memorandum) for the Chemical and Biological Defense Program (CBDP).2 1 Atpress, the current DASD(CBD) is Dr. Gerald Parker. 2 ThePOM is used to define funding and programmatic priorities for DoD, and each pro- gram must review its own activities and submit that analysis to the agency.

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INTRODUCTION 15 ORGANIZATION OF THE REPORT This report is organized into five chapters. Chapter 1 describes the statement of task, the committee process, and the purpose for perform- ing the study and provides a brief overview of the amorphous nature of the threat and challenges the CBDP faces. Chapter 2 discusses the CBDP mission and the various frameworks that the CBDP organizational ele- ments use to address their areas of responsibility. The chapter goes on to discuss the committee's view of the mission and introduces the Science and Technology (S&T) Capability Categories that it has identified in order to address the statement of task. Chapter 3 describes core S&T capabilities that are necessary for the CBDP and considers where these capabilities may best be obtained. In Chapter 4 the committee discusses a strategic capabilities-based planning approach the CBDP could adopt as a way to unify the various program elements around a single set of needs for the program. Chapter 5 discusses the importance of relationships with the end users and the research-development-acquisition (R-D-A) transition, and makes some comments and suggestions for long-term management of the CBDP S&T program, including discussion geared toward the individual DoD labora- tories, with the aim of sustaining the core capabilities. Findings and rec- ommendations are found at the end of each chapter and in the Summary. THE COMMITTEE PROCESS The committee was asked by DoD to perform this study under strin- gent time constraints. Over a period of approximately three months, the committee gathered information through a series of briefings, site visits, and interviews with individuals and groups, including stakeholders in the CBDP and operators that rely on the CBDP to support their missions. These included DoD Laboratory personnel; Joint Science and Technology Office for Chemical and Biological Defense (JSTO-CBD), Joint Program Executive Office for Chemical and Biological Defense (JPEO-CBD), and Joint Requirements Office for Chemical, Biological, Radiological, and Nuclear Defense (JRO-CBRND) personnel; CBDP customers, including some US Combatant Commands (COCOMs) and Services; and represen- tatives from organizations and agencies within the broader CBD commu- nity, including Cooperative Threat Reduction (CTR) and Global Emerging Infections Surveillance and Response System (GEIS) within DoD, as well as representatives from the Department of Homeland Security (DHS) and the Department of Health and Human Service (HHS). In addition to the formal briefings and roundtable discussions men- tioned above, committee subgroups conducted site visits at US Army Dugway Proving Ground (DPG), US Army Natick Soldier Research,

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16 CORE CAPABILITIES IN CHEMICAL AND BIOLOGICAL DEFENSE Development, and Engineering Center (NSRDEC), US Army Medical Research Institute of Infectious Diseases (USAMRIID), US Army Medical Research Institute of Chemical Defense (USAMRICD), and the Edgewood Chemical Biological Center (ECBC). At the various sites, the committee had the opportunity to view relevant facilities, meet with the facility senior leadership, and have discussions with principle investigators and other relevant personnel. Further details on the committee's data-gathering efforts can be found in Appendix A. The committee also received documents and other materi- als for review and made specific information requests between meetings that were submitted through the office of the DASD(CBD). Unfortunately, only a fraction of the written information requested was made available to the committee.3 Despite this, the committee is confident that they were able to fully meet their charge with the information received during brief- ings and site visits. Information received during the data-gathering process was exam- ined during committee deliberations and the findings, conclusions, and recommendations are described in this report. THE THREAT IS AMORPHOUS The Threat Cannot Be Defined Solely by the Number of Expected Casualties The United States remains the dominant conventional military force, but experience in a succession of wars--from Vietnam to Afghanistan-- have made it clear that a conventional force cannot necessarily respond effectively to non-conventional engagements. The use of improvised explosive devices (IEDs) and explosively formed projectiles (EFPs) pro- vides simple examples: both classes of weapons were well known, but because they were widely available and inexpensive, they have caused politically significant numbers of casualties, and have required dispro- portionately expensive countermeasures (e.g., armored vehicles, types of operations). The war in Afghanistan is not about exchange ratios or attrition of forces; it is about political advantage, and the patience of the Afghani, Pakistani, and American people regarding the course of the war. Is there potential for adversaries to create chemical and biological weapons that are as effective as IEDs and suicide bombers? If so, why have they not already been tried? The answer to the first question is 3 For example, the committee became aware of a report entitled "Chemical and Biological Defense Core Capabilities" released by the Institute of Defense Analyses in March 2007. The committee was not able to review this report during the course of the study.

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INTRODUCTION 17 certainly "Yes"; to the second, the answer is "We don't know." One of the characteristics that have made IEDs so attractive is that explosives of many sorts are readily available during a time of war. A powerful force is familiarity and habit, and if an innovator experimenting with chemical or biological weapons could prove them "successful" (where success would not necessarily be measured in people killed), the technology is readily available for broader use. Chemical and biological weapons (CBW) have the characteristic that the advantage presently lies strongly with the attacker. There are many possible weapons, from those that are highly developed and very familiar (e.g., hydrogen cyanide, classical nerve agents, anthrax) through more advanced and less well understood threats (e.g., non-traditional agents or NTAs, and tularemia), to hypothetical threats (e.g., genetically engi- neered viruses) (see Box 1.1). Some of these agents might be used in large-scale, force-on-force engagements; others in "insurgencies of attri- tion" designed to force the United States to withdraw from a theatre due to financial and political fatigue. It is impossible technically--and unfea- sible economically--to try to provide solutions to all threats. There is no analog to "stealth" or "nuclear weapons" or "overhead assets." Scientific and technical innovations that provide such commanding advantage to neutralize the threat for a period of decades do not currently exist. More- over, because this area of conflict involves everyone at the border between warfare and medicine, including military personnel and civilians on both sides of the conflict, it has--in the United States, but not in hands of some adversaries--regulatory constraints that slow development in ways that are unfamiliar to DoD. The problem is fractal: for every agent or organism, and for every countermeasure, there is a variation--and one that might be easy to implement--that escapes the countermeasure. The United States simply cannot afford to deal with all threats on an individual basis and there is no universal solution. It must choose what problems to solve. Not to choose--the strategy it has largely followed--has resulted in ineffec- tive or uncertain defensive capabilities against many agents. As a result, even in best cases, combatant commanders have a (very) limited ability to estimate the influence of CBW on proposed operations especially when used in innovative ways. (See Appendix B.)

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18 CORE CAPABILITIES IN CHEMICAL AND BIOLOGICAL DEFENSE BOX 1.1 Today's Threat to the Force Historical biological threat The primary traditional threat from biological warfare agents was to the force on a distant battlefield in a time of war, by a nation state. Until the 1990s, most experts believed a biological attack on the homeland to be very unlikely. The biological warfare enterprise within nation states was viewed as similar to nuclear or chemical weapons enterprises. The dozen or so agents of concern would have been grown and weaponized on an industrial scale (in ton quantities), at a few facilities at closed sites. The predominant threat was thought to be an aerosol. Weapons of war--planes and missiles--had been designated to carry the munitions. Today, the threat to the force worldwide is probably much like the threat to our domestic population An attack on the force may be more likely to come from a non-state actor. An attack on our US citizens is widely perceived to likely come from a non- state actor or a scientist insider.a A few grams of biological agent might stop or greatly impact a military opera- tion at home or abroad. A few kilograms of biological agent delivered from a motorcycle or boat could have near nuclear equivalence. While the high-casualty threat is still by aerosol, food (unlikely water) con- tamination could also cause casualties. The small "weapons lab" footprint and the small size of an effective weapon make intelligence very difficult. Finally, the United States is not very good at predicting threats of any kind.b. The challenges of biological security differ from those of nuclear securityc Much less is known about state biological weapons programs than about state nuclear weapons programs. Non-state actors will not have a nuclear program, but might obtain a weap- on, or fissile materials that have been produced by others. Non-state actors might either obtain a biological weapon or produce one. Pathogens are ubiquitous when compared to the few critical isotopes need- ed for nuclear weapons. Few pathogens possess the potential to kill on the scale of a nuclear weap- on, but many could cause chaos. Pathogens replicate and therefore require different accountability stan- dards than are used for management and control of chemical and nuclear materials

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INTRODUCTION 19 B iotechnologies are widespread globally in civilian settings versus nuclear technology held by only tens of nuclear states. Bioscience, knowledge, and experts number in the tens of thousands rather than in the thousands for nuclear. Progress in biodefense--against states and non-states--has not kept pace with change in threat Sensors and physical protection are still core defenses against the biothreat (for both civilian and military personnel). o The United States probably overestimates their effectiveness in an asymmetric environment. o CONOPS for sensors are not well conceptualized. o Physical protection may only be used after a threat is identified, which would likely occur too late for the protective equipment to be most effective. The United States probably has not yet adequately embraced the opacity of the threat. o It will be much, much more difficult to prepare for and defend against than prior threats. A robust S&T base to respond to the unknown may be more beneficial than very specific counter measures. The model for biological security within our service laboratoriesd is similar to nuclear "surety" 1. Personal Reliability 2. Agent Accountability 3 Physical Security 4. Laboratory Safety There is considerable disagreement across the community regarding the real cost and value of this approach, AR50-1.e a Graham and Talent; A World At Risk, http://www.absa.org/leg/WorldAtRisk.pdf. b Richard J Danzig; October 26, 2011, Driving in the Dark: Ten Propositions About Prediction and National Security. c Everywhere you look: Select agent pathogens. http://www.upmc-biosecurity.org/website/ resources/publications/2011/2011-03-03-select_agent_pathogens.html. d See AR50-1, http://www.fas.org/irp/doddir/army/ar50-1.pdf. e There are four studies from 2008-2009 on this point: NAS, DSB, Trans-Federal Task Force, and NSABB.

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20 CORE CAPABILITIES IN CHEMICAL AND BIOLOGICAL DEFENSE There Are Choke Points What are the choke points in producing technology that would pro- vide effective defense against at least some of the threats the United States and its allies might face? There are a number, not all of them under the control of DoD. The threat, although long-standing, is one for which there is very little operational experience, and substantial resistance on the part of DoD to realistic modeling and experimentation. The argument often made is that "there are no good models and simulants." It is probably largely incorrect, but more importantly, when it is cor- rect, then developing good simulants, to enable realistic simulation, should be recognized as a priority. Without realistic information about the problem, one cannot develop a solution. There is almost no red-teaming--a critical weakness when there is no operational experience. There is no prospective examination of how chemical and biological weapons might be used in innova- tive ways in the hands of adversaries with different legal, ethical, and financial constraints than those under which we operate, and with different operational and political goals and objectives. The approach used would never anticipate, for example, the chemi- cal and biological equivalent of a suicide bomber, or an EFP, or a building denial weapon. At least some of the responsible labo- ratories seem to not be committed to identifying problems and finding solutions, but rather to continuing existing, and often outmoded, themes. The rules constraining acquisition within DoD, regulatory clear- ance, clinical trials, and negotiations with the US Food and Drug Administration seriously slow the development of vaccines and therapeutics intended for in vivo use in humans, as well as the adoption of modern highly multiplexed diagnostics. US universities--the best in the world in almost all areas of applied biology, genomics, biochemical mechanisms of disease and toxicity, biomedical materials, and many other relevant areas--are widely unengaged in problems specific to DoD needs. The US pharmaceutical industry also has not been effectively engaged, in part because of strict financial rules that come with working with the government, and in part because military mar- kets are too small to be interesting financially. DoD has been ineffective in formulating programs that would engage large pharmaceutical companies. The problem is made more complex by the fact that the pharmaceutical industry is one of the most

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INTRODUCTION 21 internationalized, and there are few big pharmaceutical compa- nies that only operate in the United States. The mindset underlying the prioritization and evaluation of pro- grams has not been informed and skeptical, as a good engineering program should be. Rather, it has often pursued technology based on unrealistic objectives and evaluated against weak and unrealis- tic standards with little or no consideration of cost or practicality. New Tools Are Available To balance the difficulties of this area, however, there is also an explo- sive growth of relevant biological and biomedical science, deep interests shared by military and public health sectors, and a biomedical establish- ment that is the best in the world. The problem of CBD has been in the category of "too hard" for decades but new breakthroughs hold great promise for this problem: The reduction in the cost of genomic sequencing has been remarkable. The pharmaceutical industry has developed an extraordinary competence in toxicology, mechanisms of infectious disease, and resistance of pathogen-based disease to therapeutic agents. Analytical instrumentation for bioanalysis (as applied in biomedi- cal research and civilian medicine) has developed very rapidly. Industrial toxicology--driven both by regulatory requirements and by environmental concerns--has begun to move from pure engineering to engineering supported by science. Reporting of disease and data-based public health has become a rapidly evolving area. Simulation and modeling has developed enormously as comput- ers and user interfaces have developed. Drones and robots have developed rapidly and have the potential to augment existing sensors and collectors for some tasks. Relatively little of this technology has been transferred to organizations responsible for CBD, so, for appropriate problems, there is the potential for significantly increasing capabilities just by using existing technology. The DoD effort in CBD has also been hindered by its inability to form close connections with academic laboratories, and by the practice of keeping much of the research internal to DoD laboratories. In fact, almost none of the fundamental science required for CBD lies primarily in DoD, although specific applications of that science to threat agents likely do.

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22 CORE CAPABILITIES IN CHEMICAL AND BIOLOGICAL DEFENSE Metrics for Success In the absence of operational experience against a determined and innovative adversary using live weapons and counting real casualties, how is the United States to understand whether its technology, objec- tives, and strategy are effective? It seems clear that the only replacement for reality is realistic experiments (red team on blue team) using realistic simulants, and computer modeling. The computer modeling in this area is a crutch: it is safe and inexpen- sive relative to real exercises, but ineffective in providing solid engineer- ing information to use in building better and more realistic models. The lack of empirical data on which to base the models is an important con- tributor to the absence of useful models. The experimentation carried out by DoD in the CBDP is strongly academic, and usually so removed from plausible use that it is difficult to believe that it would help the COCOMs to understand and evaluate the program's impacts, how best to protect their forces, to carry out their operations in the face of these weapons. They would figure it out with time (as, with the help of other countries, they figured out the IED problem), but the time required to do so could have profound impact on operational readiness and effectiveness and on the course of missions. PROPOSED APPROACH The foundation of addressing the complexity of chemical and bio- logical defense is to begin with clarity of purpose in what DoD aspires to achieve. This means describing 1. the scope of events that could unfold to threaten national security, 2. the range of strategies for responding to these events, 3. how the consequences of events and performance of the response are measured, and 4. the choices made about which defense and response capabilities to implement and grow, necessarily reflecting tradeoffs among capabilities, risks, and costs. Describing each of these elements of a chemical and biological defense strategy is difficult. Planning tends to focus on narrow conceptions of threats and responses derived from historical events. Outcomes tend to be described in terms of consequences which can be easily measured, such as fatalities and injuries. Options tend to be developed based on incre- mental modifications to current materiel and operations. Each of these approaches is inadequate for addressing the innovative nature chemical and biological threats.

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INTRODUCTION 23 Instead, planning must expand the range of options considered in each element. Iterative review and realistic red-teaming challenge assumptions built into plans and promote innovations in defense to suc- cessfully respond to the threats. The scope of red-teaming and review should encompass the threats and activities against which performance is assessed and the evaluations of performance are made. Doing this type of planning is difficult and requires dedication of resources and consideration of time to allow it to occur. There are numer- ous examples of attempts to do this poorly. Chapter 4 provides more details on how to implement this approach to strategic planning. When used, it leads to informed choices about implementable strategies to improve security and defense capabilities. FINDINGS AND RECOMMENDATIONS In exploring the state of the chemical and biological warfare threat, the committee identified two principle findings: Mission and Strategy Finding 1.1: The threat is unpredictable, changing, and dependent on the nature of conflict. The CBDP cannot rely on breakthroughs in intel- ligence on adversaries' chemical or biological terrorism or warfare pro- grams to inform how its investments are prioritized. Finding 1.2: The program has not adapted to the changing nature of the chemical and biological threat. It is impossible technically--and unfea- sible economically--to try to provide solutions to all potential threats. The United States simply cannot afford to deal with all threats on an indi- vidual basis, and there is no universal solution--it has to choose which problems to solve.

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