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Summary
The Department of Homeland Security (DHS) is preparing to build the National Bio- and
Agro-Defense Facility (NBAF), a new state-of-the-art high-containment facility that will replace
the aging Plum Island Animal Disease Center and will serve as a linchpin in protecting U.S.
agriculture from foreign animal disease threats. DHS selected Manhattan, Kansas, as the site for
the new NBAF after a site-selection process that involved an environmental impact statement to
model the potential spread of foot-and-mouth disease (FMD), one of the most serious foreign
animal disease threats, and a threat risk assessment (TRA) to estimate security risks associated
with sites under consideration. The Government Accountability Office (GAO) had raised
concerns about DHS’s analysis and methods. Hearing those concerns, Congress instructed DHS
to complete a site-specific biosafety and biosecurity risk assessment (SSRA) of the proposed
NBAF facility in Manhattan, Kansas, before construction funds would be obligated. The
legislation (P.L. 111-83, see Box 1-1) also directed the National Research Council to conduct an
independent evaluation of the SSRA to determine its adequacy and validity (see Box 1-2 for the
Statement of Task).
The National Research Council convened a multidisciplinary committee of experts (see
Appendix A for committee biosketches) to provide DHS with feedback on its initial work plan
and to evaluate the adequacy and validity of the final SSRA. In March 2010, the committee
issued a privileged preliminary letter report to provide DHS with guidance on its proposed
approach for conducting the SSRA; DHS accepted most of the committee’s recommendations
and revised its work plan accordingly. In June 2010, the completed SSRA was delivered to the
committee for review. During July and August 2010, DHS supplemented the SSRA with
responses to questions and concerns from the committee.
Assembling the data and performing the SSRA of NBAF was a large undertaking;
therefore DHS and its contractors should be commended for performing the SSRA within a
remarkably short time frame. This final report constitutes the committee’s evaluation of DHS’s
SSRA.
OVERALL ASSESSMENT
The committee evaluated the SSRA’s methods, facility design plans, and mitigation
strategies. The committee found that the models used in performing the SSRA appear to be
appropriate and that many of the SSRA’s general conclusions are valid. The SSRA has
considered the major release pathways (aerosols, fomites, liquid waste, and solid waste), as
recommended in the committee’s preliminary letter report (see Appendix B), and has addressed
mitigation strategies for each. DHS has also appropriately responded to GAO’s prior criticism
that it had inappropriately dealt with a potential plume from an airborne release of foot-and-
mouth disease virus (FMDv); the SSRA uses a state-of-the-art puff dispersion model to simulate
the aerosol transport of pathogens, which turned out to be a less critical pathway of FMDv
spread than the near-site exposure of cattle. However, as described in the findings below, the
1
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EVALUATION OF THE NBAF SITE-SPECIFIC RISK ASSESSMENT
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committee found that the SSRA had several major shortcomings with respect to potential risks
and impact scenarios, and there are some critical limitations in the SSRA’s execution and
analysis.
The committee found that the SSRA has many legitimate conclusions, but the SSRA is
not entirely adequate or valid. The SSRA does not account for the overall risks associated with
operating the NBAF and conducting FMDv work in Manhattan, Kansas. The inputs and
assumptions for the models are inadequate because they do not fully account for how a biosafety
level 3 agriculture (BSL-3Ag) and BSL-4 facility would operate, how pathogens might be
released, and which animal populations might be exposed. The SSRA sometimes used arbitrary
assumptions and did not account for uncertainties, some of which require experimental data that
are currently not available but that could greatly alter the outputs. Consequently, the committee
is concerned about the validity of the actual risk and impact levels determined by the SSRA’s
outcomes from the models.
Given more time, the SSRA may have progressed further and may have better addressed
some of the concerns expressed in this report. The committee thus views this as a notable first
step in an iterative process aimed at identifying and minimizing risk and determining actions that
will need to be taken.
FINDINGS
The SSRA shows that constructing the NBAF in Manhattan, Kansas, carries a number of
risks and that the impact of an FMDv release could potentially have significant economic, health,
and national security impacts. Some risks and impacts are generic to any high-containment large-
animal facility, whereas others are specific to the Manhattan, Kansas, site. The risk of release is
primarily a generic concern, whereas the risk of infection, spread, and impact is largely related to
the site. The SSRA’s estimates indicate that the probability of an infection resulting from a
laboratory release of FMDv from the NBAF in Manhattan, Kansas approaches 70% over 50
years (see Figure 3-1) with an economic impact of $9-50 billion. The committee finds that the
risks and costs could well be significantly higher than that, and elaborates on those findings
below.
Finding 1: The SSRA lacks evidence to support the conclusion that the risk of release that
results in infection is very low relative to the risk of infection introduced from an external
source.
The SSRA states that “given the combination of proven biocontainment design and
robust operation procedures and response planning, the NBAF operations in Manhattan, Kansas
overall brings extremely low risk relative to the greater risk of the intentional or accidental
introduction of FMDv by an external source” (page 1, SSRA follow-up letter, July 28, 2010).
Although the committee affirms that engineering and operational safeguards can substantially
lower the risk of release, the committee does not concur with the implied conclusion of the
SSRA that there is a very low risk of release that would result in an infection. That comparison
“to the risk of intentional or accidental introduction” is misleading because the SSRA does not
consider or quantify the risk of infection from an external source; thus, with no data for
comparison, the SSRA’s conclusion of “extremely low risk” is invalid.
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SUMMARY 3
Furthermore, the SSRA’s characterization of risk as very low is inconsistent with the risk
of infection presented in the SSRA’s estimates over the expected lifetime of the NBAF. The
SSRA did not account for the cumulative risk of a release and infection that could spread across
the expected life span of the NBAF. Assuming that the SSRA risk estimates are credible and
reliable, if the risk probabilities across all escape pathways and scenarios had been taken into
account, the SSRA would have indicated that an escape of a pathogen, such as FMDv, and an
ensuing disease outbreak is more likely than not to occur within the 50-year life span of the
NBAF. As previously mentioned, the SSRA’s estimates indicate that a release of FMDv
resulting in infection outside the laboratory has a nearly 70% chance of occurring with an
economic impact of $9-50 billion. Also, because the SSRA did not account for important
uncertainties and risk factors as discussed below, the SSRA could well have underestimated the
risk of pathogen release and transmission and its consequences. In many scenarios considered,
the numbers probably represent conservative estimates of risk.
Finding 2: The SSRA overlooks some critical issues, both site-specific and non-site-specific,
that could significantly elevate the risk of accidental release and spread of pathogens.
While the SSRA considered site-specific characteristics that affect risk— including the
area’s high risk of tornadoes and it being in the vicinity of a transportation hub for cattle and
other livestock—it neglected to consider the risks associated with the NBAF’s proximity to a
metropolitan area and other animal facilities. This includes exposure and fomite risks for Kansas
State University (KSU) and its football stadium (which would potentially expose a large human
population), its College of Veterinary Medicine (where sick and susceptible animals are treated
and where there are large numbers of transient animal patients), and other research facilities (and
movement of personnel between KSU, the Biosecurity Research Institute, and the NBAF). In
addition, the SSRA neglected to consider the maintenance and cleaning of BSL-3Ag and BSL-4
large animal pens, which would result in aerosol formation of pathogens and emissions much
greater than were assumed in the aerosol scenario in the SSRA. The cleaning scenario is likely to
lead to significantly increased risks of infection through fomites and airborne pathways.
Finding 3: The SSRA has several methodological flaws related to dispersion modeling,
tornado assessment, and epidemiological modeling. Thus the committee believes that
questions remain about the validity of the overall risk estimates.
A common flaw in the execution of the dispersion, tornado, and epidemiological models
was that many of the assumptions used for the model parameters were arbitrary and subject to
user bias. Although sensitivity analyses were conducted, these did not systematically address
many important uncertainties and risks related to release, transmission, and mitigation. Many
scenarios were potentially overoptimistic, and could well have led to major underestimations of
the risks. Specifically, the committee could not determine the input parameters used for the
NAADSM and could not independently validate the results.
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Finding 4: The committee agrees with the SSRA’s conclusion that for FMDv, long-distance
plume transport will likely be less important than the near-site exposure of cattle.
Near-site exposure of cattle and other livestock are especially a concern in Kansas State
University’s College of Veterinary Medicine, sales barns, and the many cow-calf operations and
feedlots within a few miles of the NBAF; beef cattle sales barns are a particular focal point for
secondary transmission of FMDv in this setting. These livestock and their transport across
neighboring states will serve as major factors in the spread and amplification of an FMD
outbreak throughout the United States. As shown in the SSRA, the high level of animal
movement and the presence of sales barns near Manhattan, Kansas, significantly increase the
degree of FMD spread and its economic impact.
Finding 5: Substantial gaps in knowledge make predicting the course of an FMD outbreak
very difficult, which led to weaknesses in the SSRA.
Predictions of epidemic size are only as robust as the weakest links in the model, and the
SSRA identified a lack of good records and data on interstate livestock transport. Without data,
there is no way to fill in the gaps and improve precision beyond the scope of expert opinion. In
addition, without improvements in data quality, it remains difficult to obtain any robust forecasts
of overall outbreak effects. Even though specific data are lacking for predicting the nature and
scope of SSRA escape scenarios, data are available on recent FMDv introductions or laboratory
escapes and they provide valuable lessons in understanding realistic expectations for mitigation
measures and disaster preparation plans for various outbreak scenarios.
Finding 6: Although the economic modeling was conducted with appropriate methods, the
epidemiological estimates used as inputs to the SSRA were flawed.
The epidemiological modeling assumptions that were used in the economic assessment,
such as depopulation rates and outbreak duration, were overoptimistic in their estimates. The
committee questions the SSRA’s assumption that its proposed mitigation strategy would contain
the spread of FMD by culling 120-720 herds per day (page 230 of the SSRA). The committee
does not think that infected herds could be detected and culled at that rate, and therefore
questions the validity of the mitigation strategy to limit the effects of an outbreak. If fewer herds
could be culled each day, the spread and impact would be much higher than indicated by the
SSRA. Consequently, the use of flawed epidemiological inputs resulted in economic estimates
that were also flawed and invalid, albeit derived in a methodologically sound manner.
Finding 7: The committee agrees with the SSRA’s conclusion that early detection and rapid
response can limit the impact of an FMDv release from the NBAF, but is concerned that
the SSRA does not describe how the NBAF could rapidly detect such a release.
Early detection is critical for limiting the spread of infection, therefore it will be
important to develop extensive real-time surveillance for FMDv and other pathogens being
worked on at the NBAF before the laboratory becomes operational. Surveillance will also be
critical in detecting whether a leak or spill has occurred within the NBAF so that steps can be
taken to minimize and mitigate its release. To implement FMD surveillance and response in the
United States, numerous capabilities will need to be developed related to real-time diagnostics,
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SUMMARY 5
real-time full-genome surveillance, a real-time active surveillance system, and response plans
with appropriate parties involved in FMD diagnosis, control, and eradication.
Finding 8: The SSRA lacks a comprehensive mitigation strategy developed with
stakeholder input for addressing major issues related to a pathogen release. The mitigation
strategies that are provided do not realistically demonstrate current or foreseen capacity
for how federal, state, and local authorities would effectively respond to and control a
pathogen release.
With regard to human health and the NBAF’s site in Manhattan, Kansas, the committee is
concerned about the lack of clinical isolation facilities and world-class infectious disease
clinicians experienced in diagnosing and treating laboratory staff or communities exposed to
BSL-4 pathogens. With regard to animal health, the SSRA acknowledges that the Manhattan,
Kansas, region is a hub of animal movement for the entire United States and that infected
animals would be expected to move across the country and cause pockets of infection at great
distances from the initial source of infection, but the mitigation strategies do not address
outbreaks of such magnitude. Given that a pathogen release from the NBAF may occur despite
all efforts to prevent that from occurring, it will be necessary to create realistic and credible
mitigation strategies for the release of a pathogen.
Finding 9: The committee agrees with the SSRA’s conclusion that human error will be the
most likely cause of an accidental pathogen release, and fomite carriage is the most likely
way that a pathogen would escape the facility’s outer biocontainment and biosecurity
envelope.
Safe practices are of paramount importance given that the SSRA presents human error as
the most likely source of accidental releases. To enhance safe operation and reduce the risk of
human error identified in the SSRA, the committee agrees that key NBAF personnel will need
adequate ongoing training, education, and evaluation of skills. Furthermore, there will need to be
zero tolerance of deviations from biosafety standards and practices recommended by the CDC
and USDA.
Finding 10: The committee agrees with the SSRA’s conclusion that investment in biosafety
and biosecurity engineering and the training of personnel and responders can reduce the
risks, but is concerned about current design plans that potentially compromise safety
measures.
The NBAF will venture into a new and unprecedented area of BSL laboratory operations
with respect to its mainland location, scale of operations, and scope of agents. Given that the
SSRA states that the cost of a release (such as a release of FMDv) would be very high, the
facility will need to be engineered beyond the accepted standards to an exceptionally high level
of biosafety and biosecurity. To function safely, it will need to be a state-of-the-art facility with
state-of-the-art equipment and state-of-the-art biosafety practices. It would be prudent not only to
abide by the strongly recommended guidelines set forth in the most recent Biosafety in
Microbiological and Biomedical Laboratories (BMBL), but to also glean best practices and
guidance from existing BSL-4 laboratories. The committee is seriously concerned about the
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EVALUATION OF THE NBAF SITE-SPECIFIC RISK ASSESSMENT
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SSRA’s current designs which omit redundant HEPA filters—but are strongly recommended by
the BMBL—for reasons of practicality and cost-savings. Any facility design compromises due to
budgetary limitations will need to be viewed as inconsistent with the mission of providing a
state-of-the-art facility with minimal risk of pathogen escape from containment. The critical
engineering and construction plans will affect the containment potential for the life span of the
facility. Once construction of the NBAF is complete regardless of the location, funding will need
to be maintained to assure continued safe operation and maintenance.
Finding 11: The SSRA’s qualitative risk assessment of work with BSL-4 pathogens in large
animals was inadequate.
The qualitative risk assessment was inadequate because it failed to fully consider the
characteristics of the pathogens and the risks of working with BSL-4 pathogens in large animal
facilities. The committee does not concur with the SSRA’s finding that its quantitative risk
assessment regarding FMDv and Rift Valley fever virus (RVFV) sufficiently represents the
range of risk regarding the other pathogens that will be studied at the NBAF, that is, the
pathogens that are included in the qualitative risk assessment. The committee does not agree that
the BSL-3 quantitative risk assessment adequately frames the risks associated with operating a
BSL-4 large animal facility, because it is insufficient to use BSL-3 pathogens to predict risks
associated with BSL-4 pathogens that are zoonotic and for which no treatment is available.
Given that the qualitative risk assessment was inadequate and that the SSRA did not perform a
quantitative risk assessment for BSL-4 agents, further evaluation of risks and mitigation
strategies will need to be established for BSL-4 agents (for example, Nipah and Hendra viruses
or other emerging BSL-4 zoonotic pathogens) to identify ways of minimizing the risks
associated with working with those agents in a large animal facility setting.
ADDITIONAL REMARKS
The SSRA team should be applauded for its effort in conducting an extensive risk
assessment in such a short period of time. Although the committee’s findings express major
concerns about the validity of some of the SSRA’s conclusions, the work that was completed
constitutes a huge step forward compared with previous risk assessments of its kind and should
be viewed as a solid starting point.
The nation clearly needs an institution to support comprehensive research programs for
the study of foreign animal and zoonotic diseases, including detection, diagnosis, and means of
mitigation (drugs, vaccines, and genomic forensics). Such activities require a capability to work
with all known threat agents (not just the eight infectious agents listed in the SSRA), multiple
pathogen introductions, and emerging and unknown disease threats. For these reasons, the
committee agrees that there is a need for a facility like the NBAF to be constructed and operated
in the United States.
Constructing a BSL-3Ag and BSL-4 facility of the magnitude planned for the NBAF, one
that is capable of large animal work on a scale greater than other high-containment laboratories,
undoubtedly presents new and unknown risks that could not be accounted for in the SSRA
because of a lack of data and experience. Given the constraints of the design framework and the
short timeframe available for data collection and analysis, the committee finds that the
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SUMMARY 7
limitations of the data, facility design details, and operating practices may have limited the scope
that the SSRA could adequately address at this time. As more data, facility designs, and
operational plans emerge, updated analyses may be appropriate to better evaluate the risks posed
by a BSL-3Ag and BSL-4 large animal facility in Manhattan, Kansas.
The SSRA and the committee identify some sources of risk that can be addressed as part
of the design, preparation, and long-term operation of the NBAF to reduce risk wherever it is
located. Though the SSRA and the committee offer several points for consideration to reduce the
risk of a pathogen release and its consequences, further risk analysis is needed to determine the
extent to which these measures would reduce risk. Ultimately, policymakers will need to decide
whether the risks are acceptable related to constructing and operating the NBAF in Manhattan,
Kansas, and DHS will need to determine steps to minimize risk and impact if construction and
operation should proceed as planned.
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