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Naval Forces’ Defense Capabilities Against Chemical and Biological Warfare Threats Prologue There are two central themes in this report: the first is the belief of the authoring committee in a serious potential threat to U.S. naval forces from chemical or biological weapons; the second is the fact that the Department of the Navy needs to establish a more robust defensive posture against these threats. The following brief chronologies drive these themes home. AUM SHINRIKYO 1994. Members of the Japanese cult Aum Shinrikyo attack a hotel in Matsumoto, Japan, with sarin gas, and succeed in killing a targeted judge (among others). March 1995. The sarin attack on the Tokyo subway system kills 12 people and sends hundreds to the hospital. 1990 to 1995. Cult members conduct as many as a dozen attacks in the Tokyo metropolitan area with anthrax and botulinum toxin, with the intent each time to kill millions. Included are multiple attacks on U.S. naval bases in Japan. For technical reasons related to agent purity, these attacks fail. The Navy was apparently not aware of these attacks. Nor was it apprised of them even in the wake of courtroom testimony in the prosecution of cult members.1 1 WuDunn, Sheryl, Judith Miller, and William J. Broad. 1998. “Sowing Death, A Special Report: How Japan Germ Terror Alerted World,” New York Times, May 26, p. A-1. See also Kaplan, David E., and Andrew Marshall. 1996. The Cult at the End of the World: The Terrifying Story of the Aum Doomsday Cult from the Subways of Tokyo to the Nuclear Arsenals of Russia, Crown Publishers, New York.
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Naval Forces’ Defense Capabilities Against Chemical and Biological Warfare Threats AL QAEDA 1998. Osama bin Laden issues an edict, a “fatwa,” for holy war against the United States and calls for attacks on U.S. military and civilian personnel around the world. He calls it a “holy duty” of Muslims to acquire weapons of mass destruction for the “fight against Jews and Crusaders” in order to “terrorize the enemies of God.” In well-planned and well-executed operations, al Qaeda forces attack U.S. embassies in Africa.2 October 2000. A second successful attack on U.S. assets outside the continental United States is executed—this time against the USS Cole in Yemen. September 11, 2001. Al Qaeda brings the reality of its holy war to the U.S. homeland with attacks on the World Trade Center and the Pentagon. 2002. Director of the Central Intelligence Agency George Tenet testifies that “al Qaeda was working to acquire some of the most dangerous chemical agents and toxins.”3 Documents recovered from al Qaeda facilities in Afghanistan show that bin Laden was pursuing a biological weapons research program. According to Bush administration and intelligence reports, much of the al Qaeda leadership remains at large.4 DEPARTMENT OF DEFENSE December 1993. Secretary of Defense Les Aspin announces the Defense Counterproliferation Initiative aimed at improving the ability of U.S. power projection forces to project into and prevail in hostile environments where weapons of mass destruction are present. 1994. According to Defense Planning Guidance, “chemical and biological weapons are a likely condition of warfare.”5 1996. The General Accounting Office concludes that the military Services “face many of the same problems they confronted during the Persian Gulf conflict in 1990 and 1991.”6 2001. According to the Quadrennial Defense Review Report, “The new defense strategy identifies key operational goals for deterring conflict and con- 2 Bodansky, Yossef. 2001. Bin Laden: The Man Who Declared War on America, Prima Publishing, Roseville, Calif. 3 Statement by George J. Tenet, Director of the Central Intelligence Agency. 2002. “Worldwide Threat: Converging Dangers in a Post 9/11 World,” Senate Select Committee on Intelligence, February 6. 4 Bodansky, Yossef. 2001. Bin Laden: The Man Who Declared War on America, Prima Publishing, Roseville, Calif. 5 Department of Defense. 1994. Defense Planning Guidance, Washington, D.C. (classified). 6 U.S. General Accounting Office. 1996. Chemical and Biological Defense: Emphasis Remains Insufficient to Resolve Continuing Problems, GAO/NSIAD-96-103, Washington, D.C., March.
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Naval Forces’ Defense Capabilities Against Chemical and Biological Warfare Threats ducting military operations…. Number 3 [of these goals is to] project and sustain U.S. forces in distant anti-access and area-denial environments…. [This requires] ensuring U.S. forces can sustain operations under chemical or biological attack.”7 2001. Assessments by the General Accounting Office indicate improvements are needed by the DOD and the Services in inventory management and risk assessment procedures, in addition to addressing the treatment of chemical and biological (CB) casualties.8 7 Rumsfeld, Donald H., Secretary of Defense. 2001. Quadrennial Defense Review Report, Washington, D.C., September 30. Available online at <www.defenselink.mil/pubs/qdr2001.pdf>. 8 U.S. General Accounting Office. 2001. Chemical and Biological Defense, Improved Risk Assessment and Inventory Management Are Needed, GAO-01-667, Washington, D.C., September; U.S. General Accounting Office. 2001. Chemical and Biological Defense, DOD Needs to Clarify Expectation for Medical Readiness, GAO-02-38, Washington, D.C., October.
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Naval Forces’ Defense Capabilities Against Chemical and Biological Warfare Threats Executive Summary At the request of the Chief of Naval Operations (CNO), the Naval Studies Board, under the auspices of the National Research Council, established a committee to assess the defensive capabilities of both the U.S. Navy and U.S. Marine Corps against chemical and biological warfare threats. In response to the terms of reference and the special tasking from the CNO for this study,1 the Committee for an Assessment of Naval Forces’ Defense Capabilities Against Chemical and Biological Warfare Threats devoted its attention to evaluating the current operational posture of naval forces with regard to defending against chemical and biological weapons across the entirety of its operations and to identifying the opportunities for improvement afforded by operational and technical advances. The attacks of September 11, 2001, and the subsequent anthrax attacks significantly raised awareness of chemical and biological threats, providing additional impetus to this study. In that context, the committee developed a consensus of concern that the nation’s naval forces—with a few notable exceptions in the Marine Corps and the Fifth Fleet operating area, which includes the Persian Gulf—are not as prepared as they could be and should be to deal with such 1 In a letter dated June 28, 2001, to the president of the National Academy of Sciences, the CNO wrote: “I am especially pleased that the [Naval Studies] Board is now about to initiate a study of naval force defense capabilities against chemical and biological warfare threats. Recent world events demonstrate that forward-deployed naval forces are constantly at risk even in today’s relatively peaceful world. I look forward to supporting this study and receiving the conclusions on issues with direct operational implications such as developing concepts of naval operations to deal with emerging terrorist threats.”
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Naval Forces’ Defense Capabilities Against Chemical and Biological Warfare Threats threats, and it formulated recommendations for improving operational capabilities in the near as well as far term. The committee’s findings and recommendations highlight these areas: The seriousness of the threat; An approach to dealing with the threat focused on mission success and based on risk management principles, as opposed to the prevailing (and largely unachievable) philosophy of avoiding contamination; The critical role of naval leadership in ensuring readiness throughout the force and in sustaining improvements in posture; The need for consistent requirements and supporting systems in training and reporting to ensure readiness; and The contributions that technology can—and cannot—make for both medical and non-medical defense. CHEMICAL AND BIOLOGICAL WEAPONS—A REAL AND PRESENT THREAT TO NAVAL FORCES While the committee is convinced that naval forces face a real and present threat, Navy leadership presented a wide range of views about the reality, importance, and practicality of defending against chemical or biological weapons. With a few exceptions, most notably the Fifth Fleet, the Navy needs to improve its preparedness for today’s chemical or biological threats. In particular, more attention should be paid to address threats in port, at shore installations, and throughout the logistics trains, either in the continental United States (CONUS) or outside the continental United States (OCONUS). The Fifth Fleet’s attention to the chemical warfare (CW) and biological warfare (BW) problem is undoubtedly due to its recognition of a threat and vulnerabilities in its operating area of responsibility, especially in the commercial ports and foreign bases on which it depends. The Marine Corps, in contrast to the Navy, seems to have paid much more attention to the problem, although it too has opportunities for improvement—especially at many of its bases. Both the chemical and the biological threats of today are characterized by wide availability of agents and a variety of delivery methods, from simple to complex. The threats posed by various agents and delivery methods are real today almost everywhere the Navy operates—on the open ocean and in the littorals, and especially in port and at shore installations. Because of the Navy’s dependence on foreign ports and its growing emphasis on warfighting in the littorals, the committee believes that the Navy should, in fact, be more concerned about limited, asymmetric attacks in such environments than about more massive, open-ocean encounters on which its defensive posture has been historically based.
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Naval Forces’ Defense Capabilities Against Chemical and Biological Warfare Threats GUIDING PRINCIPLES TO MITIGATE THE PROBLEM The committee found that effective approaches to chemical and biological warfare defense are based on a few important principles: Recognize that chemical weapons and biological weapons constitute different threats. Chemical and biological weapons, and ways to deal with them, are often discussed together, and indeed some equipment and procedures for defense work for both. These weapons differ, however, in the effects that each produces; thus, there are unique requirements for dealing with each and even more specific requirements for various classes of agents within either category. In general, chemical warfare is better understood than biological warfare, and defensive measures for chemical warfare are more mature (largely because of the use of CW in World War I and the years of development of both offensive and defensive capability since then; biological warfare was not as seriously studied until World War II). Chemical warfare is expected to be a threat at the tactical or operational level because of the immediacy and localization of chemical agent effects. Biological warfare is more likely a theater- or strategic-level threat because of the delay in the onset of symptoms and effects, which may be widely dispersed, especially with contagious agents. Manage to risk, not to threat alone. Threat alone should not form the basis for developing a defense, as it can drive requirements to unrealistically expensive levels in addressing the full scope of potential scenarios, especially when considering the nearly unlimited possibilities that can arise with asymmetric adversaries. (The Department of Defense (DOD) has recognized this issue and is shifting from threat-based to capabilities-based planning.2) Instead of managing to threat alone, balanced risk assessments should form the basis for deciding “how much (capability) is enough.” Such assessments should combine a broad view of adversary intent and force vulnerabilities with an analysis of the operational consequences of adversary actions and defensive countermeasures to these (passive and active), to understand the impact on accomplishing a mission and on overall campaign success. (Chapter 1 provides a simple example, created by the committee, of the comparative risk—defined as vulnerability × consequences—to operations in an environment of chemical or biological threat from nations and terrorist enemies with capability and intent to attack.) Adopt a reasoned view of chemical and biological weapons exposure environments. In the Cold War, massive attack scenarios led to requirements for chemical and biological defense for the Services on the basis of exposures at the point of release (i.e., the highest level). The risk-based approach recommended by the committee ties levels of protection not to the worst case, but to an accep- 2 Rumsfeld, Donald H., Secretary of Defense. 2001. Quadrennial Defense Review Report, Washington, D.C., September 30. Available online at <www.defenselink.mil/pubs/qdr2001.pdf>.
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Naval Forces’ Defense Capabilities Against Chemical and Biological Warfare Threats tance of casualties in the scenario or environment of operations that are consistent with those expected from conventional weapons. Equipment design requirements can then be based on exposures expected for almost all (but not 100 percent) of environments, and the temptation to categorize the problem as “too hard to solve” can be avoided. GENERAL FINDINGS AND RECOMMENDATIONS In developing operational and technical findings and recommendations as directed by this study’s terms of reference, the committee observed that two general themes emerged. Both are foundational and must be addressed for achieving the improvements in defensive posture needed. They are (1) leadership for lasting improvements and (2) the approach for getting started: Naval leadership for chemical and biological warfare defense. In spite of both the general military and the naval-specific concerns and guidance regarding preparedness for chemical and biological warfare defense articulated for more than a decade, little improvement in the Navy’s posture could be found. The Navy’s senior leadership should commit to strengthening and integrating chemical and biological defense throughout all Navy functions in order to achieve both near-term and sustained improvements. Leadership within the Marine Corps has been more visible and sustained, but gaps in preparedness remain. For both Services, especially the Navy, this includes having a much higher profile in the Joint Chemical and Biological Defense (CBD) Program to ensure that naval-specific requirements are being adequately addressed. (See also the discussion in the section below and in Chapter 4 on non-medical science and technology.) Getting started with operational net assessments. Chemical or biological warfare defense alone will never be perfect, nor are there single robust elements within any defensive approach. Consequently, a defense-in-depth strategy—that is, a layered defense that exploits the synergies among individual components in order to have the strongest possible performance of the overall system—should form the basis for the future. Models for developing defensive capabilities can be found in the Fifth Fleet, with selected Marine base commands, with most commercial fleet operators, with the British Royal Navy, and with the U.S. Air Force. The Navy and Marine Corps should get started with an operational net assessment, particularized to each combat or supporting commander’s operating environment. OPERATIONS: SPECIFIC FINDINGS AND RECOMMENDATIONS This section provides specific findings and recommendations on operational issues related to naval chemical and biological warfare defense.
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Naval Forces’ Defense Capabilities Against Chemical and Biological Warfare Threats Operational requirements. The committee found that the Navy—and in some respects the Marines—has not defined the chemical or biological warfare defense operational requirements for mission success. The committee recommends that this situation be remedied throughout the entire force by defining a comprehensive concept of operations (CONOPS) with supporting policies and practices. This CONOPS should address all dimensions of naval operations that go into sustaining a mission: how to prevent an attack, how to recover from and minimize the impact of an attack, how to restore naval operations after an attack, and, above all, how to achieve mission goals. How U.S. naval forces plan to operate and fight in a chemical or biological warfare environment should then drive naval priorities in doctrine, organization, training, materiel, leadership, personnel, and facilities (DOTMLPF), as well as in research and development (R&D) and acquisition. Focal point for CONOPS. The Navy appears to lack a focal point for the development of policy, concepts of operations, and doctrine for chemical or biological warfare defense; the Marine Corps appears to place greater emphasis on the problem. The committee recommends that the Navy Warfare Development Command (NWDC) and the Marine Corps Combat Development Command (MCCDC) be clearly designated as the primary authorities and given the requisite resources for the development of policy, concepts of operations, and doctrine for chemical and biological warfare defense issues. While NWDC has contributed nuclear, biological, and chemical (NBC) defense guidance in publications on tactics, techniques, and procedures (TTPs), its alignment role and capabilities should be strengthened through realistic experimentation and testing and in promulgating CONOPS and supporting policies for how naval forces will execute their warfighting and base support missions in an environment that may be or has been contaminated with chemical or biological agents.3 The Marine Corps should build on the work already under way at MCCDC, which has been active as a focal point in joint efforts, and on the experiences with the Corps’s Chemical and Biological Incident Response Force (CBIRF), and the Navy should leverage that work. In particular, NWDC and MCCDC should assess the technical basis for assumptions defining their own doctrine and undertake tests of these assumptions in field experiments in relevant naval operating environments. Readiness. Navy readiness for chemical and biological warfare defense needs improvement. Sustained improvements toward remedying these deficien- 3 Effective October 1, 2001, the CNO assigned the Commander, U.S. Atlantic Fleet, concurrent duties of Commander, Fleet Forces Command (CFFC). The CFFC is responsible for coordinating, establishing, and implementing integrated requirements and policies for manning, equipping, and training Atlantic and Pacific fleet units during the interdeployment training cycle. NWDC will report to the CFFC as its immediate superior in command for purposes of warfare innovation, concept development, fleet and joint experimentation, and the synchronization and dissemination of doctrine.
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Naval Forces’ Defense Capabilities Against Chemical and Biological Warfare Threats cies require establishing standards for readiness, training and exercising to those standards, and developing a reporting system attuned to this area. Special urgency should be given to bases and shore installations and to the logistics chain. In fact, if the Navy chooses to implement only one recommendation from this report, it should be that of committing to dramatically improve readiness. More specifically, the Navy should institute a system of exercises, training, assessment, and reporting aimed at meeting higher standards of chemical and biological warfare readiness. Central to this effort is to define appropriate standards of readiness in each of its mission areas—standards derived from the operational requirements generated by the net assessment recommended in the preceding section, “General Findings and Recommendations,” and refined through the efforts of NWDC (and MCCDC as needed for the U.S. Marine Corps). The Marine Corps’s Marine Expeditionary Units (Special Operations Capable) (MEU(SOC)s) are a good example to follow, since they have established readiness standards for themselves that are being extended throughout the Marine Corps. SCIENCE AND TECHNOLOGY: SPECIFIC FINDINGS AND RECOMMENDATIONS All of the research, development, and acquisition for chemical and biological warfare defense is carried out through the legislatively mandated Joint CBD Program and is organized around two principal areas—(1) Non-Medical Science and Technology and (2) Medical Defense. Although the committee was tasked to make R&D projections in specific time frames—to 2005 (near term), to 2010 (mid-term), and to 2015 (far term)—it found this practically impossible for two reasons: The establishment of the Department of Homeland Security and the significantly increased investment by the National Institutes of Health (NIH) in medical countermeasures and vaccines are leading to increased activities in these areas, which should in turn impact the Joint CBD Program. The committee believes, however, that its recommendations remain applicable. The Department of the Navy should follow closely and leverage any such future activities to accelerate developments appropriately in the Joint CBD Program. The Joint CBD Program has been undergoing substantial reorganization and reassignment of responsibilities that should affect current near-, mid-, and far-term plans. The Navy is urged to engage more actively with the program to influence those changes. However, the committee does offer observations on activities in the context of the near, mid-, and far term based on the technical or development difficulties associated with a particular area.
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Naval Forces’ Defense Capabilities Against Chemical and Biological Warfare Threats Non-Medical Science and Technology The Non-Medical Science and Technology part of the Joint CBD Program is organized in five “commodity” areas: contamination avoidance, individual protection, collective protection, decontamination, and modeling and simulation. Detailed findings and recommendations for each commodity area are presented in Chapter 4 of this report and are summarized in Box 4.1; more detailed descriptions of the technologies appear in Appendix C. The findings and recommendations regarding the Joint CBD Program in the Non-Medical Science and Technology area and the Navy’s relationship to it are given below. Joint CBD Program: Non-Medical Science and Technology. Two aspects of this part of the Joint CBD Program appear not to serve naval needs well and can be ameliorated with appropriate attention by the Navy: The first of these is that this part of the program has been and remains dominated by a philosophy of “contamination avoidance,” a laudable goal indeed, but one that the committee believes is unrealistic as the driving force, considering the broad range of possible asymmetric attacks. Such a philosophy requires early detection to facilitate avoidance and the identification of a threat agent as early as possible, which in turn drives investments heavily toward sensor systems for both standoff and point detection to provide rapid early warning. The committee recommends that the Navy champion a fundamental change in philosophy in this part of the Joint CBD Program—one that moves toward a risk management approach which assumes that contamination will happen and focuses on managing the response. Such a shift should result in a more balanced investment portfolio, to also include detection capabilities to support decontamination and diagnostics; characterization of agent fate on exposed surfaces; protective equipment in consonance with tactics, techniques, and procedures that better facilitate operating through an exposure; and rapid and “friendly” decontamination techniques and procedures. A second observation is that the requirements and acquisition processes of the entire Joint CBD Program have pushed acquisition schedules out far too long into the future for providing capabilities that could significantly improve the current operational posture. Those processes are undergoing revision, with reassignment of responsibilities within the Joint CBD Program and the Office of the Secretary of Defense (OSD). The committee recommends that the Navy seize the opportunity to ensure that processes are truly revamped to accelerate the introduction of improvements into the fleet. Navy participation. Achieving the changes in the Joint CBD Program recommended above would be challenging enough if the Navy were fully engaged in the joint process. But in fact the Navy has been the least aggressive of the Services in its participation. Personnel from the Naval Sea Systems Command (NAVSEA), the Office of Naval Research (ONR), and the Commander,
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Naval Forces’ Defense Capabilities Against Chemical and Biological Warfare Threats Fleet Forces Command (CFFC), assigned to represent naval interests are well informed and committed to their assignments; however, they do not have sufficient support from senior Navy leadership and commands to analyze joint requirements in the naval context and, if need be, to influence the program for it to address Navy-unique needs. It was not clear to the committee how serious an issue this might be. Lacking a robust, independent assessment on its own, the Navy is captive to equipment and accompanying operational procedures derived largely from the more stressing requirements of environments expected for ground forces in combat, based on conditions at or near the point of agent release. The recommendation in the section “Operations,” above, that NWDC develop and promulgate a carefully analyzed and gamed concept of operations would go a long way toward addressing this issue. Knowledgeable personnel at NWDC could also provide to naval personnel involved in the Joint CBD Program sorely needed support and expertise for ensuring that naval needs are adequately defined. In carrying out this recommendation, the Navy should make good use of Naval Research Laboratory (NRL) personnel who have well-established reputations in the chemical and biological science and technology (S&T) community. Testing and evaluation. The maritime environment introduces unique factors that should be explicitly considered for accepting equipment from the Joint CBD Program and developing procedures for its use. The Navy’s research, development, testing, and evaluation (RDT&E) community is limited in its capabilities to make such assessments. The committee recommends that a much more serious and comprehensive program in testing and evaluation be undertaken by the Navy, to include both modeling and simulation and realistic test environments for chemical and biological warfare defense. The committee, in fact, recommends that the Navy consider dedicating a ship to chemical and biological simulant testing in a fashion analogous to the use of the ex-LSD Shadwell for fire research. Medical Defense Medical defense against chemical and biological warfare agents is critically important in preserving combat effectiveness of naval forces. Medical defense has great commonality across all of the Services—the affected asset in all cases is the individual Service member, not a weapon system or a logistics facility. While the level of threat may differ, individuals’ medical defense needs are the same whether personnel are stationed on a forward-deployed aircraft carrier, at an airbase, or at a home port. Medical defense reemphasizes the need to differentiate clearly between the response to chemical agents and the response required to wage an effective medical defense against biological agents. Exposure to chemical agents is quickly detectable because the effects are rapid; there are also specific medical responses available for some of the agents. In contrast, biological attacks will most certainly be silent and will not present an immediate, concentrated mass casualty situation. Biological warfare defense is clearly the most
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Naval Forces’ Defense Capabilities Against Chemical and Biological Warfare Threats challenging from a medical perspective, and, not surprisingly, the committee has found the greatest gaps between that threat and our capacity to manage the consequences of an attack. The findings and recommendations for medical defense, especially as they relate to the Navy, can be grouped in three general areas: Medical training. Medical training remains a critical determinant of success in medical defense and an area in which senior leadership can be most effectively applied. It is also an area in which Navy medical personnel are significantly lagging behind their counterparts in other Services. Enhanced training of naval personnel, medical and—as noted for operations—non-medical, represents the highest-payoff, near-term investment that can be made by the naval Services, and the committee urges that it be done now. Training is not without costs, but the costs are relatively low. Moreover, without better training, the equipment and medical countermeasures provided by the technology developers cannot provide the levels of effectiveness for which they are designed. Technical and operational shortfalls. Many of the technical and some of the operational shortfalls in naval medical capabilities are the result of overreliance on the Joint CBD Program.4 The committee’s leading recommendation for addressing these issues is to define the nature of the shortfalls in terms of navalspecific requirements. This analysis involves the full range of developmental activities, as discussed for operations: doctrine, organization, training, materiel, leadership, personnel, and facilities (commonly referred to as “DOTMLPF” analysis). This kind of analysis and formalization of naval requirements should be undertaken by the naval Services doctrine and warfare development centers, NWDC and MCCDC, informed and supported by qualified medical personnel. There is, in fact, a finite number of drugs, vaccines, and antidotes available to support medical CW or BW defense. Vaccines could provide the most comprehensive defense against BW agents, but the Department of the Navy should be under no illusions that there will be a stream of effective approved vaccines (besides those for smallpox and anthrax) available in the near term to mid-term based on DOD priorities alone.5 In the absence of adequate supplies of effective vaccines, casualties must be anticipated, but observant sailors, corpsmen, clinicians, and commanders, in combination with modern diagnostic tools, will allow early medical interventions to save lives, minimize contamination and further 4 Due to their expanded scope of chemical and biological defense associated with the war on terrorism, the Department of Homeland Security and the Department of Health and Human Services, especially in the area of vaccines, may impact the Joint CBD Program. The committee believes, however, that its recommendations remain applicable, although the Department of the Navy should follow closely and leverage these activities as much as possible. 5 The Department of Homeland Security may choose to accelerate some programs, but it is far too soon to assess if and when vaccines important to the military will be included.
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Naval Forces’ Defense Capabilities Against Chemical and Biological Warfare Threats exposures, and preserve warfighting strength. The committee recommends (1) that recognition of symptoms and pre-incident intelligence should be the earliest input into an efficient distributed disease reporting and analysis system, and (2) that such a system should be developed and deployed to allow effective and timely medical defensive measures to be taken. (Detailed medical defense S&T assessments and recommendations are presented in Chapter 5 and summarized in Box 5.3.) Medical policy issues. Embedded in the acquisition programs of DOD and the Joint CBD Program for both vaccines and laboratory diagnostics is the requirement for Food and Drug Administration (FDA) certification of drugs, devices, and vaccines. According to current DOD policy, the FDA provides the standards for the safety and efficacy of systems that are used to protect military personnel. FDA certification for BW and CW medical systems is problematic because objective clinical trials involving humans cannot be conducted on the diseases or injuries produced by CW or BW agents. The committee noted two major shortfalls in the development programs of the Services and the medical defense part of the Joint CBD Program: (1) the certification of critical laboratory reagents and (2) the slow progress toward certification of drugs and vaccines against BW pathogens. These shortfalls continue despite evidence that the FDA commissioner has shown increasing willingness to modify the certification systems unique to BW and CW. He has recently provided relief from some of the documentation requirements on “orphan” drugs or vaccines that are only effective against BW pathogens.6 The commissioner has also recently signed a letter authorizing the use of adequate animal studies to meet the efficacy rule. Yet the Joint CBD Program has been slow to act on those “openings” to shorten development and approval times. Liaison and cooperation between the Department of Health and Human Services and the Department of Defense must be continuously exercised to facilitate ways of establishing safety and efficacy in systems designed for military use. This kind of dialogue cannot be assumed to represent the Navy’s interests or needs. The committee recommends that the Secretary of the Navy champion those issues within which large gaps in capabilities expose sailors and Marines to unnecessary risk. CONCLUSION—LEADERSHIP TO SUSTAIN THE COMMITMENT A strategy to implement the committee’s recommendations can pay dividends over the short term, mid-term, and long term. In the short term, it can produce dramatic improvements to force readiness and overall situational aware- 6 U.S. Food and Drug Administration. 2002. “FDA Amends Its Regulations to Provide for Approval of Certain New Pharmaceutical Products Based on Animal Efficacy Data,” FDA News, P0217, Department of Health and Human Services, May 30. Available online at <http://www.fda.gov/bbs/topics/NEWS/2002/NEW00811.html>.
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Naval Forces’ Defense Capabilities Against Chemical and Biological Warfare Threats ness. In the mid-term, technical enhancements can contribute significantly to a reduction in operational vulnerabilities. In the long term, naval forces should find themselves well prepared to cope with adversaries willing and able to exploit CW or BW in campaigns of asymmetric warfare aimed at gaining operational and strategic leverage. In the short term and mid-term, the Navy and Marine Corps can make good progress but need to accelerate the improvement of their capability to successfully sustain operations—across the full spectrum of missions—in the face of robust adversary use of chemical or biological weapons. The current “business as usual” approach will not suffice. There is critical need for increasing the priority that Navy and Marine Corps leadership assigns to protecting naval forces against CW and BW threats. The lessons from the post-Gulf War era, during which the Navy’s attention to CW and BW defense fell off dramatically, suggest a serious leadership challenge for the long term—namely, sustaining institutional commitment to improving the operational posture of naval forces with regard to defending against chemical and biological weapons as the threat evolves to ever more capable levels. Guided by sound risk management practices, naval forces can go far toward reducing the dangers—and therefore, the threat—of any chemical or biological attack.
Representative terms from entire chapter: