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Summary
The goal of the US Department of Defense's (DoD's) Chemical and
Biological Defense Program (CBDP) is to provide "support and world-
class capabilities enabling the US Armed Forces to fight and win deci-
sively in chemical, biological, radiological, and nuclear environments." 1
To accomplish this objective, the CBDP must maintain robust science
and technology capabilities to support the research, development,
test, and evaluation required for the creation and validation of the prod-
ucts the program supplies to the Services. As the threat from chemical
and biological attack is an evolving one, due to the changing nature of
conflict and rapid advances in science and technology, the core science
and technology (S&T) capabilities that must be maintained by the CBDP
must also continue to evolve. In order to address the challenges facing
DoD, the Deputy Assistant Secretary of Defense for Chemical and Biologi-
cal Defense (DASD(CBD)) asked the National Research Council (NRC)
of the National Academy of Sciences to conduct a study to identify the
core capabilities in science and technology that must be supported by
the program.
The NRC Committee on Determining Core Capabilities in Chemical
and Biological Defense Research and Development has examined the
capabilities necessary for the chemical and biological defense science and
1 US Department of Defense. 2010. "Department of Defense Chemical Biological Defense
Program Annual Report to Congress 2010." Note that this report focuses only on the chemi-
cal and biological aspects of the program.
1
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2 CORE CAPABILITIES IN CHEMICAL AND BIOLOGICAL DEFENSE
technology program in the context of the threat and of the program's
stated mission and priorities. This report contains the committee's find-
ings and recommendations. It is intended to assist the DASD(CBD) in
determining the best strategy for acquiring, developing, and/or maintain-
ing the needed capabilities.
Because science and technology development is a long process, the
products and materials from the CBDP must not only respond to the
needs of the Services today, but also anticipate those of the future. Since
the United States cancelled its offensive program for biological weapons
in 1969 and for chemical weapons a decade later,2 DoD must rely on
analysis and simulations to understand how these agents might be used.
Offensive programs are being conducted by adversaries where under-
standing of their intentions and capabilities is uncertain; at least some of
the technology developed by nation states has escaped, and capability
in all parts of the world in civilian uses of biotechnology and medicinal
chemistry is rising rapidly. Because of uncertainty about how much pro-
tection current materiel and procedures will provide, there is potential for
a gap between needs and deployable capabilities. For example,
· Do we need new, more effective vaccines?
· Does the current protective gear adequately protect, and against
what agents?
· Would warfighters be able to "fight through" operations that
use conventional agents (for example, persistent nerve agents)
deployed in conventional ways? In innovative ways (for example,
on suicide bombers)? With unconventional agents?
· How much would operational tempo be slowed by attacks on
logistics and supply chains using chemical or biological weapons,
and what would be the influence of successful attacks on opera-
tional tempo?
Many of the questions related to the capabilities that warfighters and
combatant commands have at their disposal could be answered, but the
current technical and organizational structure is not designed to answer
them. Instead, the process for prioritizing research efforts and allocating
resources is based on a requirements-driven process that promotes a focus
on the development of technical solutions without adequately consider-
ing the range of contexts in which they may be used. This focus carries
over into the approaches taken in evaluating the efficacy of the products.
Although a device or material meets its threshold and objective bench-
2 In 1969, the United States renounced first use of chemical weapons, and in 1991 renounced
retaliatory use as well; the United States ratified the Chemical Weapons Convention in 1993.
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SUMMARY 3
marks in a test chamber or facility, these benchmarks may not necessarily
represent the range of operating environments.
The committee identified 39 core chemical and biological defense
S&T capabilities and created a framework that groups them in six cat-
egories. In Chapter 3, the committee discusses these S&T capabilities and
identifies where, in their view, the capabilities should be obtained by the
CBDP. To inform their thinking about which S&T capabilities are actually
core and comment on where the capabilities may be found the committee
developed a decision tree (Figure 3.1). Using this decision framework the
committee found that almost all of the capabilities can be found outside of
the service laboratories. The committee went on to identify, for a variety
of possible reasons, some capabilities that should be maintained within
DoD service laboratory infrastructure. For each capability, research and
development (R&D) and test and evaluation (T&E) are discussed sepa-
rately and typically were not best suited to the same organization.
The committee considered four types of institutions with laboratories
that may be suited to provide CBDP core capabilities and organized them
from typically having the most fundamental-science-focused to the most
product-focused research. These institutions are (1) academia, (2) other
governmental facilities (e.g., the National Institutes of Health, Centers for
Disease Control and Prevention, Department of Energy National Labs,
National Institute of Standards and Technology), (3) DoD laboratories
and facilities, and (4) industry (e.g., pharmaceutical companies). For some
capabilities, T&E requires use of actual agent;3 institutions other than DoD
laboratories may be well suited to do the work but would need to do so
in close collaboration with DoD.
Table S.1 summarizes the committee's judgments about how well
suited the types of institutions are for R&D and for T&E with respect to
26 of the core capabilities. Dark shades indicate an institutional category
that the committee views as well suited to maintain a given capability for
the CBDP, while the lighter shade indicates less well-suited locales. The
white boxes indicate that the institutional category is, in the committee's
view, not well suited to maintain the capability. The other 13 capabilities are
cross-cutting science and technology that the committee views as necessary
for effective RDT&E for any of the capabilities defined in the preceding
capability categories. Discussion of the potential locales for the cross-cutting
science and technology capabilities can be found in Chapter 3. The commit-
tee does not intend to imply that each of the 13 cross-cutting capabilities be
maintained exclusively, or indeed at all, within DoD.
3 Actual agent testing refers to the actual chemical or biological agent the capability is
eing tested against (e.g., Vx, Sarin, sulfur mustard, anthrax, tularemia, botulinum toxin),
b
as opposed to testing with simulants.
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Table S.1: Science & Technology Core Capabilities R&D T&E
OGF
DoD
Industry
OGF
DoD
Industry
Academia
Academia
1. Enabling CBRN ISR 6. Cross Cutting Science and Technology
Information Acquisition & Analysis Acquisition, Maintenance and Transport of
Health Monitoring Critical Chemical and Biological Reagents
Environmental Monitoring Simulation
Unknown Agent Identification and Characterization Informatics
2. Chemical & Biological Agent Detection Forensics
Analytical Methods Discovery A Education and Training
Instrumentation Development A Behavioral Analysis
Sensor Systems Development A Systems Analysis and Engineering
Agent Transport Analysis A Repurposing Commercial Technologies
3. Individual & Collective Protection Systems Biology
A
Table 3-1
Controlled Molecular Transport Materials Discovery Synthetic Chemistry and Biology
Barrier Materials Engineering A Materials Science
Personal Protective Systems Development A Statistical Measurement Design
Collective Protective Systems Development A Test & Evaluation
Physiology A
4. Medical Countermeasures
Target Discovery In the committee's view, this category is:
Broadside no caption
Regulatory Science not well suited
Mechanisms of Delivery & Delivery Systems less well suited
Animal Models N/A well suited
Host Response very well suited
Pre-Clinical Studies N/A to provide this capability to CBDP
Clinical Trials (GLP and GMP)
Medical Product Development R&D: research and development
5. Hazard Assessment, Mgmt and Decon T&E: test and evaluation
Decontamination Methods Discovery A OGF: other govenment facilities
Decontaminant Development A A: the actual chemical or biological agent is
Decontamination Resilient Materials Development A important for T&E
Decontamination Systems Engineering A N/A: the capability does not have a major
A
4
Agent Transport & Viability Analysis R&D or T&E component
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SUMMARY 5
When considering the various locales for obtaining S&T capabilities,
it is important to recognize that
1. the analysis of the various laboratory locales is general, and indi-
vidual performers within a category may be exceptions;
2. the color coding of each category represents the aggregate of rea-
sons considered, including but not limited to
a. reputation and experience at providing the given capability,
b. the extent to which the capability requires work with classified
information,
c. limitations on the locale of the capability resulting from inter-
national treaties or other laws,
d. the need to maintain important capabilities, at least in part,
at government facilities to ensure availability (e.g., Biological
Safety Level 4 facilities).
The committee identified a number of concerns that affect the program's
ability to sustain these core capabilities, including
· the amorphous and changing nature of the threat;
· the breadth of the mission and lack of shared strategic objec-
tives across all of the chemical and biological defense enterprise
elements;
· a requirements-driven, as opposed to capabilities-based, process
for prioritizing and directing RDT&E and acquisition;
· a funding structure that minimizes local flexibility over allocated
RDT&E funds; and
· challenges to effective engagement with individuals and organi-
zations external to DoD.
RDT&E for the CBDP rely upon capabilities that have been primarily
resident in the military departments because of both the classified nature
of the original offensive program and specialized aspects of the problem.
While key competencies and special facilities in the laboratories and test
ranges remain important to the program, most of the expertise in relevant
science and engineering now lies outside of DoD. The work that is done
largely by the military (for example, protective suits) is not carried out in a
way that allows its effectiveness to be evaluated usefully, and the transfer
of commercial technology into DoD laboratories (e.g., in gene sequencing)
is inefficient and expensive. The fundamental questions of how RDT&E
programs should be organized, and how much of chemical and biological
defense research is really "core" to DoD require rethinking.
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6 CORE CAPABILITIES IN CHEMICAL AND BIOLOGICAL DEFENSE
FINDINGS AND RECOMMENDATIONS
Program Framework and Structure
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.
Finding 2.1: The CBDP mission is too broadly stated. The stated mis-
sion of CBDP is to "Provide global chemical, biological, radiological, and
nuclear defense capabilities in support of National Strategies." The mis-
sion statement is large enough to allow for a wide variety of interpreta-
tions, making it challenging for both the customers of the program and
the facilities that support its work to understand the program priorities.
The CBDP has responsibilities that span missions from protecting
the warfighter and providing support to the warfighter, to defending the
United States from attack (i.e., Homeland Defense) and supporting local
authorities following a chemically or biologically related incident (i.e.,
Consequence Management, Foreign or Domestic). Events requiring the
Department to perform each of these missions could unfold in innumer-
able, unexpected ways; for example,
· naturally occurring disease or unintentional chemical exposures
may be difficult to distinguish from intentional attacks;
· intelligence, as noted above, has historically proved uncertain and/
or unreliable in assessing the chemical and biological (CB) threat;
· innovations, as witnessed in the case of improvised explosive
devices, will certainly occur in the development and use of chemi-
cal and biological weapons; and
· the United States has a poor understanding of the intentions of
those who might use chemical and biological weapons, and an
even poorer understanding of the barriers that prevent them from
doing so.
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SUMMARY 7
The combination of a broadly stated mission and numerous uncer-
tainties calls for top-level guidance on focus and priorities, which the
current program lacks.
Finding 2.2: There is no program-wide CB defense strategy, nor com-
mon characterization of the program elements among the participating
organizations. The many different organizations currently involved in the
CBDP (e.g., Office of the Assistant Secretary of Defense for Nuclear, Chemi-
cal, and Biological Defense Programs/Chemical and Biological Defense
(OASD(NCB/CB), Joint Requirements Office for Chemical, Biological,
Radiological, and Nuclear Defense (JRO-CBRND), Joint Science and Tech-
nology Office for Chemical and Biological Defense (JSTO-CBD), and Joint
Program Executive Office for C hemical and Biological Defense ( JPEO-CBD)
each view the chemical and biological defense mission from different per-
spectives. Although this can be expected based on their different roles, the
coordination and collaboration between these groups is far from seamless.
As a result, the program has been--and continues to be--limited in its abil-
ity to deliver fielded solutions in a timely manner.
Finding 2.3: Strategic priorities tend to change with changes in senior
leadership. As a result, efforts requiring sustained and/or longer-term
commitments (e.g., medical countermeasures) are unable to deliver timely
results, if at all.
Recommendation 2.1: The DASD(CBD) should lead a mission and
strategy development activity that aligns all of the program elements
and offices. The differences among offices in how they portray and com-
municate their stories, in their priorities, and in the terminology they
use to describe the program are stark. Bold moves are needed to break
the current stagnation that permeates the chemical and biological S&T
and acquisition environment. Tweaking the management or refocusing a
few projects will not be sufficient. The recommended alignment activity
should promote a shared understanding of and commitment to key priori-
ties for maintaining the core capabilities and expertise needed to fulfill the
overall program mission and strategy.
Science and Technology
Scientific Collaboration
Finding 3.1: Little of the fundamental science required for CBD lies pri-
marily in the DoD. The vast majority of the scientific research performed
in the United States occurs in academic and industrial laboratories. This is
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8 CORE CAPABILITIES IN CHEMICAL AND BIOLOGICAL DEFENSE
particularly true for the biological and chemical sciences which lie at the
nexus of the S&T requirements of the CBDP.
Finding 3.2: The military laboratory community is not as strongly part-
nered with key external research institutions and programs as it could
and should be. As the United States has a robust S&T sector, the CBDP
can and does engage with individuals and organizations external to DoD
and the US government, but this typically occurs at the individual project
or principal investigator level, and not necessarily on a sustained basis.
The CBDP has not systematically promoted institutional ties with aca-
demic, industrial (especially pharmaceutical companies), and other non-
DoD laboratories or related federal programs.
Recommendation 3.1: The Director, JSTO-CBD, should ensure that the
development of a Culture of Collaboration is a high priority for all
elements of the chemical and biological defense enterprise. Although
information control requirements and contracting concerns have been
stated as barriers on both sides to collaboration, these are issues that can
and should be addressed. To ensure that the program delivers products
based on the best S&T available, the CBDP needs to find ways to partner
with the broader scientific community and other federal agencies in areas
relevant to chemical and biological defense.
Tech Watch and Adopt
Finding 3.3: There is the potential to significantly improve chemical and
biological defense capabilities by using existing technology. Despite
the nation's superb biomedical research establishment and the explosive
growth of biological and biomedical science that is relevant to DoD as
well as the public health community, relatively little of this broad compe-
tency has been applied to problems relevant to chemical and biological
defense.
Recommendation 3.2: The DASD(CBD) should establish an effective
"tech watch and adopt" component within the CBDP to bring inno-
vative solutions to ongoing needs. Program managers and scientists
within the CBDP should recognize the importance of technology watch
and adoption before a major new RDT&E investment is made. The incor-
poration of a "tech watch and adopt" concept would have at least the
following three elements: (1) mechanisms for searching and identifying
relevant breakthroughs in the literature and from the private sector; (2)
mechanisms and processes in place for incorporating innovation into the
ongoing program for the capability needed; and (3) processes for rapid
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SUMMARY 9
adoption of "tweaks" that would significantly improve existing capabili-
ties. An adjunct objective would be to get the external performers inter-
ested in CBD problems such that they might be recruited to work on the
problem.
Linking R&D Community to Operators
Finding 3.4: Separation of S&T performers from the end user is imped-
ing their ability to meet the user's needs. Individuals in the military
laboratories noted that understanding more fully the context of their work
could assist S&T personnel in developing operationally relevant products,
identifying variables or factors that would otherwise be overlooked, and
possibly shortening development time. In addition, a stronger relation-
ship between operators and R&D performers could support innovation
by enabling informed, collaborative "blue sky thinking."
Recommendation 3.3: The DASD(CBD) should survey the military
laboratories and associated facilities to identify strong relationships
between S&T performers and the warfighters, and support replication
of such interactions across the program.
Simulants for Test and Evaluation
Finding 3.5: Broadly speaking, the capacity for test and evaluation to
support the needs of the CBDP exists within DoD. Test and evaluation is
a core component of the program and important to maintain within DoD
at a high level of competency and responsiveness.
Finding 3.6: Much of the current T&E is based on unrealistic expecta-
tions of how the material or equipment being tested would actually be
used. The threat, although long-standing, is uncertain. In addition, the
lack of connection with the military operators often leads to the omission
of realistic simulation of deployment and use environments.
Recommendation 3.4: Because of the economic, logistical, and environ-
mental concerns with actual agent testing, DASD(CBD) should give
priority to the active development and production of realistic and rel-
evant threat agent simulants for both outdoor and large-chamber tests.
A single simulant, especially for chemical agents, is unlikely to possess all
of the same physical, chemical, and/or transport properties of an actual
agent; therefore, multiple simulants may be required to fully stress critical
design parameters during T&E.
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10 CORE CAPABILITIES IN CHEMICAL AND BIOLOGICAL DEFENSE
Review of Test and Evaluation Plans
Finding 3.7: Test and evaluation plans apparently are not subject to
independent external review. These plans are created internally, and
the committee observed little evidence of the use of external expertise to
review testing plans.
Recommendation 3.5: For CBD products to be viable for fielding, the
Deputy Under Secretary of the Army for Test and Evaluation should
require that (1) T&E activities be based on testing protocols that accu-
rately emulate actual operating environments (both threat properties
and operator employment) and (2) independent reviews of testing pro-
tocols be conducted.
Organization and Management
Capabilities-Based Planning, Development, and Acquisition
Finding 4.1: A requirements-driven S&T process is not a good match for
the CBDP. The planning and experimentation carried out by the CBDP
is usually so removed from plausible use that it is difficult to believe that
the Combatant Commands would know how to understand and evaluate
the program's impact, how best to protect their forces, to carry out their
operations in the face of current and/or high-probability future threats.
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 inju-
ries. Options tend to be developed based on incremental modifications to
current materiel and operations. Each of these approaches is inadequate
for addressing the evolving and innovative nature of chemical and bio-
logical threats. Moreover, the perceived goal of "100% protection" appears
to impact all aspects of the program such that few products reach the field
in a timely manner, especially in the medical countermeasures part of the
program.
Recommendation 4.1: The Office of the Secretary of Defense (through
the Assistant Secretary of Defense for Nuclear, Chemical, and Bio-
logical Defense Programs) should evaluate a shift to capabilities-based
planning, as a more appropriate approach for this program. The goal
is to adopt strategies that are flexible to provide capabilities for events
other than those anticipated, adaptive to conditions other than those that
are planned, and robust to attempts made to diminish these capabilities.
Planning should expand the range of options considered; iterative review
and realistic red-teaming should challenge assumptions built into plans
and promote innovations in defense to correspond to that in the threats.
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SUMMARY 11
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. The overall S&T focus should shift from "zero
casualties" to "mission success."
Program Management
Finding 5.1: Successful transition between the JSTO-CBD and the
JPEO-CBD offices requires a mutual agreement on appropriate transi-
tion points, encoded in multiyear program plans and budgets. Regard-
less of the chosen trigger, expertise and resources within or contracted
by JSTO-CBD and JPEO-CBD need to be appropriately positioned. This
approach would also be supportive of overlap in JSTO-CBD and JPEO-
CBD personnel engagement on the project to ensure smooth and knowl-
edgeable transitions. However, the committee observed that the partner-
ship between the JSTO-CBD and JPEO-CBD is weak and that neither
office viewed transition plans as a responsibility.
Finding 5.2: There is no end-to-end authority for the CBDP, which is
particularly problematic for medical products. Though both JSTO-CBD
and JPEO-CBD are overseen by the CBDP, there is no one office or indi-
vidual with the responsibility and authority for the entire process for any
given product. The risk--and reality--is that a transition gap between
R&D and acquisition could result in the development of a project manage-
ment "valley of death." The existing research-development-acquisition
process may be adequate for acquiring the non-medical products in the
CBDP. For the medical countermeasures program, however, FDA regula-
tory requirements must be considered early enough to influence product
development decisions. The current management structure within the
CBDP is not well suited to the task because of the lack of a whole-process,
integrated view of product development.
Recommendation 5.1: The DASD(CBD) should evaluate alternative
program management approaches, including incorporation of an end-
to-end project management authority, especially for the medical coun-
termeasures program.
Laboratory and Major Facility Management
Finding 5.3: The principal RDT&E military organizations associated
with the CBDP are benefiting from major facility investments that are
planned to provide both capabilities and capacities to meet the antici-
pated needs of the program. Operating and maintaining these facilities,
however, will place a burden on both the owning Service (principally
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12 CORE CAPABILITIES IN CHEMICAL AND BIOLOGICAL DEFENSE
the Army) and the program. The initial operating plans appear to be
resourced.
Finding 5.4: All or part of the elements required for healthy RDT&E
activities were missing at the organizations visited by the commit-
tee. A successful RDT&E enterprise should include the following ele-
ments to ensure clarity of purpose, focus of investments, and coherence
of management:
1. Clear mission and objectives
2. Continuity in leadership
3. The ability to understand, accept, and manage risk throughout
the process
4. Predictable and stable funding
5. Effective asset management at the laboratory level
6. A sense of excitement and pride in the work among the staff
Of special concern are strained relationships between JSTO-CBD and the
laboratories, the new rotational policy for military commanders in the
Army, and a trend toward increasing oversight of both technical work
and operations at the facilities.
Recommendation 5.2: The DASD(CBD) should formally review alterna-
tive laboratory management models, taking advantage of the numerous
prior studies, reviews, and evaluations of laboratory and large facility
management of S&T organizations. A principal objective is to define the
level of stewardship that the program should provide to the principal
RDT&E in-house facilities and laboratories.
Scientific Peer Review
Finding 5.5: All programs benefit from scientific peer review when
done well, and these reviews keep the skills of scientists and engineers
sharp.
Recommendation 5.3: The DASD(CBD) should implement a nested
review process for chemical and biological defense RDT&E bound by
consistent standards of rigor, frequency, and reporting. The CBDP and
its supporting laboratories would each benefit from independent, periodic
review at the programmatic and scientific levels. The CBDP should also
encourage and participate in institutional reviews. An annual roll-up
of review outcomes could help identify thematic areas of promise and
concern.
