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5
Overall Assessment, Findings, and Concluding Remarks
The site-specific biosafety and biosecurity mitigation risk assessment (SSRA) is critical
for identifying risk factors and determining what can be done to minimize the risks inherent to
the proposed National Bio- and Agro-Defense Facility (NBAF), and for determining whether
construction of the NBAF should proceed in Manhattan, Kansas. Assembling the data and
performing the SSRA on the proposed NBAF was a large undertaking. The Department of
Homeland Security (DHS) and its contractors should be commended for performing the SSRA
within a remarkably short time frame.
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 the Government
Accountability Office’s (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 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 concludes 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 working with large animals 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
57
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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 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 of the risks and impacts are generic to a high-containment
large-animal facility, and 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 FMD infection from an external source; thus, with no data for
comparison, the SSRA’s conclusion of “extremely low risk” is invalid.
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. The need to include lifetime risk estimates is consistent with
the Homeland Security Presidential Directive 9 (HSPD-9) mandate to “develop a plan to provide
safe, secure, and state-of-the-art agriculture biocontainment laboratories that research and
develop diagnostic capabilities for foreign animal and zoonotic diseases,” and is also consistent
with the National Research Council’s previous recommendation to DHS that the agency address
the probabilities of a sequence of events that would lead to a pathogen release (NRC, 2008).
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OVERALL ASSESSMENT, FINDINGS, AND CONCLUDING REMARKS 59
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.
Site-Specific
Although the SSRA accounted for the role of sales barns in increasing risk due to
Kansas’s central location as a hub of the U.S. livestock industry, the SSRA failed to account for
other site-specific factors, including:
(1) The location of the KSU College of Veterinary Medicine clinics adjacent to the
NBAF, where large numbers of sick and susceptible animals are treated and where there
are large numbers of transient animal patients.
(2) The movement of personnel between KSU facilities, the Biosecurity Research
Institute, and the NBAF, which increases risks related to fomites and respiratory
transfers.
(3) The location of the Kansas State University (KSU) football stadium in close
proximity to the NBAF, which presents a large human population that potentially could
be periodically exposed to a released zoonotic pathogen and that potentially could
transport a released pathogen outside of the area.
Non-Site-Specific
One of the most critical scenarios that the SSRA neglected to consider is the maintenance
and cleaning of BSL-3Ag and BSL-4 large animal pens; an entire room serves as the primary
biocontainment envelope. Large animal pens are normally washed daily, and this would likely
result in substantial aerosol formation of BSL-3Ag and BSL-4 pathogens in addition to fomites.
The daily cleaning of animal pens as a potential pathway of pathogen release would result in
aerosol emissions much greater than were assumed in the aerosol scenario in the SSRA. The
aerosolization of dust, dander, and other solids and liquids during daily cleaning of the large
animal facilities would place an exceptional burden on the high-efficiency particulate air (HEPA)
filters (even with the use of pre-filters), potentially increasing the risk of virus escape through the
air-handling system, which was not addressed in the SSRA. The cleaning scenario is likely to
lead to significantly increased risks of infection through fomites and airborne pathways.
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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.
Dispersion Modeling
The execution of the SCIPUFF model to estimate risk of infection associated with
exposure to airborne virus was not based on approaches described in the literature (see Cannon
and Garner, 1999; Schley et al., 2009), but instead was based on an arbitrary threshold dose of
0.1 plaque forming unit for infection, which leads to uncertainties in the estimation of risk. The
modeling also did not account for uncertainties in model parameters. A typical approach would
have been to combine concentration calculations with livestock population maps to derive dose
contours, which could be related to the probability of infection. As mentioned above, the
omission of the animal pen cleaning leads to a major underestimation of the magnitude of
aerosol release.
Tornado Assessment
The SSRA used a tornado risk assessment that is sensitive to user bias. The committee
could not determine whether the user judgments were reasonable or optimistic and therefore
could not determine whether the models underestimate the risk of a high-speed wind event, such
as a tornado, and its consequences. The use of a tornado hazard model would have eliminated the
need for user judgment, and would more appropriately provide information about the design
basis wind speed and building envelope design.
Epidemiological Modeling
The epidemiological modeling of FMD transmission was inadequate in several respects.
Many uncertainties, some of which are discussed below, were inadequately considered, so the
sensitivity analyses were insufficient and many scenarios probably were overoptimistic. Some
parameter values and assumptions used in the North American Animal Disease Spread Model
(NAADSM) were inconsistent with what is known about epidemiological and veterinary aspects
of and experience with FMD.
(1) The scope of spread was limited to seven states by the exclusive use of sales barns as
the sources of animal movement. The scope was also limited only to cattle and swine and
did not include infection of feral swine, deer, and small ruminants.
(2) The extent of spread did not address the critical elements of animal movement within
and among states. The transportation modeling methods considered animal movement
only in an indirect and superficial manner and excluded movement within and among
states (as well as incursions in and out of Canada and Mexico) by individual producers
and neighbors, therefore underestimating the spread.
(3) The response did not provide realistic assumptions regarding mitigation values of
input parameters, and the values inflated prospects of surveillance, diagnosis, available
manpower, depopulation rate, and movement bans (direct and indirect). Mitigation
strategies did not mention how and where FMDv diagnostics, research activities, and
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OVERALL ASSESSMENT, FINDINGS, AND CONCLUDING REMARKS 61
matching of vaccine to outbreak strain might be conducted if the NBAF had to shut down
or curtail some activities because of a pathogen escape or physical damage to the facility.
In epidemiology, studies generally are evaluated on the basis of internal and external
validity estimates. Internal validity estimates are related to how well a study was conducted. If
any of the elements of internal validity estimates (such as study design elements as proper
controls, correct statistical or modeling methods, assumptions, non-biased selection criteria, and
sampling methods) are inadequate, inappropriate, or flawed, then the study lacks internal
validity. Assuming acceptable internal validity, external validity estimates indicate how well and
in what detail inferences about the results of the study can be drawn. For example, restricting
epidemiological modeling to its effect on seven states that have large livestock populations
would mean that inferences about the other 41 contiguous states (with Alaska and Hawaii
excluded) cannot be drawn, so external validity would be lacking. In the SSRA, there are several
such issues that raise questions of both internal and external validity.
On the basis of the information provided, the committee could not determine the input
parameters used for the NAADSM and could not independently validate the results. As a result
of the assumptions and methodological flaws, the committee concludes that the epidemiological
results of the SSRA deflate the duration and magnitude estimates of a possible FMD epidemic.
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 that are 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. The
SSRA identified a lack of good records and data on interstate livestock transport. Whereas there
is concern about the potential role of wildlife in FMD spread, there are few resources for
incorporating wildlife data into the risk assessment model. 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. Considering that FMD has been intensely studied since 1898, when it became
the first animal disease recognized to be of virus etiology, it is sobering that knowledge of the
dynamics of viral transmission (beyond immediate contact between infected animals) is still
limited. Even though specific data are lacking for predicting the nature and scope of SSRA
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escape scenarios, data are available on recent FMDv introductions in other countries (for
example, Taiwan in 1997 and the UK in 2001), and those introductions in many ways resemble
laboratory escapes inasmuch as they were “point source” epidemics; there is also the UK
experience in 2007 stemming from a laboratory escape. Those FMD outbreak episodes provide
valuable lessons in understanding realistic expectations for mitigation measures and disaster
preparation plans for various outbreak scenarios (UK-HSE, 2007; Anderson, 2008).
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, it
would be necessary for a number of things to occur that were not described in the SSRA,
including:
(1) Development and testing of adequate real-time diagnostic capabilities for FMDv.
These include animal-side assays that could be used in the field and ensure that all U.S. state and
regional laboratories have adequate access to these capabilities so that real-time surveillance for
FMDv can be conducted in the United States.
(2) Development of real-time global full-length genomic surveillance for FMDv. This
would include:
• Developing capacity for full-genome sequencing of all FMDv isolates of interest.
• Developing the software systems needed for rapid, comprehensive analysis of genomic
data.
• Maintaining a full-sequence database of all FMDv isolates in order to facilitate rapid
matching of an escaped outbreak strain to the range of possible vaccine strains.
• Developing the information-technology system needed for making such data broadly
available to outbreak investigation, mitigation, and forensic officials.
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OVERALL ASSESSMENT, FINDINGS, AND CONCLUDING REMARKS 63
(3) Development of a real-time active surveillance system1 for FMDv in the United
States. This will include involving state and regional diagnostic laboratories, industry, and
veterinary practitioners.
(4) Development and testing (through modeling) methods and scenarios for surveillance,
control, eradication, vaccination, and mitigation of FMD in the United States. This would
include:
• Operating an emergency response model that uses continuous meteorological monitoring
equipment at the NBAF site and meteorological forecasts to provide real-time
information on transport of aerosols (FMDv) released from the NBAF.
• Ensuring that the U.S. Northern Command (NorthCom) is formally engaged in
developing plans for military assistance in the event of an FMD epidemic.
• Creating a plan in consultation with all appropriate federal, state, tribal, and private-
sector agencies and groups to rapidly detect and control an FMD outbreak in the United
States (the use of vaccine as well as traditional “stamping-out” approaches will need to be
considered).
• Requiring mandatory education and training of food-animal veterinarians in FMD
diagnosis, control, and eradication through the U.S. Department of Agriculture (USDA)
National Veterinary Accreditation Program as a component of developing an FMD
surveillance system.
• Developing contingency plans for backup diagnostic, research, and forensic laboratory
services in case the NBAF is rendered nonoperational or cannot work with FMDv due to
a release.
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.
Human Health
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 in the Manhattan, Kansas area. Given that people may
become infected with some zoonotic agents that will be worked with at the NBAF, a plan is
needed for rapid consultation with experts at one or more of the world-class high-containment
laboratory facilities (BSL-4 laboratories). In addition, a plan is needed for transporting patients
safely to a major medical center where world-class experienced clinicians are ready to care for
an exposed or ill patient in the event of a laboratory-acquired infection.
Manhattan, Kansas, is not located adjacent to world-class clinical facilities with expertise
in BSL-4 human infectious diseases. If a BSL-4 pathogen escapes or a laboratory worker
acquires an infection with a BSL-4 pathogen, the deficiency of the Manhattan, Kansas, location
1
Active surveillance is defined as “an active, ongoing, formal, and systematic process aimed at early detection of a
specific disease or agent in a population or early prediction of elevated risk that a population will acquire an
infectious disease with a pre-specified action that would follow the detection of disease” (Thurmond, 2003).
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will become immediately apparent, and the consequences will not only damage the credibility of
the federal agencies involved but will potentially cost human lives. The SSRA did not adequately
address the mitigation of this risk. It will be crucial for a world-class facility like the NBAF to
provide response plans that include world-class infectious disease clinical facilities and
physicians who can properly diagnose, contain, and treat infected individuals.
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. 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. Conducting exercises can better inform stakeholders and responders at
the local, regional, and national levels about the diseases and the relevant factors that will affect
an outbreak. There is a need for a contingency plan to cover the costs of mitigation and
indemnity.2 In addition, mitigation plans will need to be thoroughly tested, evaluated, and
updated on a regular basis to address the spectrum of credible scenarios.
It will be important to meaningfully involve relevant local and national experts and
stakeholders in a continuous, purposeful, and committed initiative to obtain realistic and
functional knowledge of the logistical and resource constraints, personnel limitations, political
and legal actions, animal movement dynamics, and animal welfare issues that will arise in the
face of a pathogen escape. The animal-owning public will need to be included in the planning
and will need to understand the consequences of an FMDv escape. A working understanding of
factors that contribute to FMD spread will need to be applied meticulously to the design and
operation of the epidemic spread models, which will help to inform decision-makers about gaps
in knowledge and data and would be relevant to inform policy options. It will also be necessary
to have action plans for mitigation that can be tested in exercises sensitizing stakeholders and
responders to what needs to be done to minimize the effects of a release of FMDv or other agent
from the NBAF.
An important mitigation strategy for conducting research on FMDv and the other
pathogens in the NBAF would be to ensure that the National Veterinary Stockpile (NVS)
receives adequate funding to carry out its mandate in accordance with HSPD-9. DHS and USDA
will need to ensure that the NVS will have the necessary vaccines, diagnostic reagents, and
supplies to respond to a major outbreak of FMD, RVF, and other infectious agents studied in the
NBAF as required by HSPD-9. Enhancing the capability of the local and regional emergency
response community, the surveillance capability of the laboratories in the National Animal
Health Laboratory Network, and the NVS will benefit U.S. agriculture and public health in the
event of any incursion of foreign animal or zoonotic disease.
2
As noted in an Institute of Medicine and National Research Council report, “private stakeholders [need to be]
compensated for losses incurred as a result of public action, such as paying farmers an indemnity for culling
diseased or suspected infected animals for an emerging disease” (IOM and NRC, 2009).
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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 Centers
for Disease Control and Prevention (CDC) and USDA.
The Laboratory Operations Timeline (Figure 1-6 of the SSRA) could be significantly
improved with regard to training by factoring in time and funds for key researchers and
technicians to undergo 1-year internships at facilities currently operating at BSL-3Ag and BSL-
4. Memoranda of agreement could be developed with a number of U.S. laboratories that have
extensive expertise and similar missions (such as the CDC, the U.S. Army Medical Research
Institute of Infectious Diseases, and the University of Texas Medical Branch at Galveston).
Sufficient time for hands-on experience will enable trainees to work with experts in maximum
biocontainment and participate in the gamut of activities mimicking those of the NBAF. Such
training cannot be duplicated by attending a series of mini-courses, 1- to 2-week “mock” training
courses, or learning by trial and error before the NBAF’s certification for full operations. The
trainees could form the core of trainers for the remainder of the NBAF staff.
There is a multi-year window of opportunity to ensure that the NBAF senior staff (such
as principal scientists and super-technicians) are technologically, intellectually, scientifically,
and culturally prepared on opening day and fully accredited to work at the highest
biocontainment levels. As shown in Figure 1-6 of the SSRA, that needed specialized training
would have to begin by the January 2014 timeframe to enable trainers to complete a 1-year
internship or rotation, acclimate, and adapt procedures to the NBAF and begin training staff in
May 2015. Furthermore, it would be of great advantage if all NBAF senior staff were hired by
2012 and provided 2-year fellowships at a national laboratory where training in biosafety and
biosecurity are integrated with modern microbiological research, development, and diagnostics.
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.
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.
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. Once construction of the NBAF is complete regardless of the
location, funding will need to be maintained to assure continued safe operation and maintenance.
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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. It would therefore
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. Doing so would inform the NBAF on
BSL-4 laboratory designs, operating practices, and training and could be used as a basis for
improving and establishing standards that would be appropriate for work in the NBAF’s BSL-3,
BSL-3Ag, and BSL-4 large animal facilities.
As the facility is still in the early design phases, the architectural and engineering firms
will need to make sure they do not compromise community public health or agricultural safety
and security. As previously mentioned, the committee is seriously concerned about the SSRA’s
current designs omitting redundant HEPA filters for reasons of practicality and cost-savings. The
BMBL strongly advocates a redundant series of HEPA filters for extremely high-risk areas such
as BSL-3Ag spaces; the NBAF qualifies as such extreme high-risk with its proposed BSL-3Ag
areas and its new BSL-4 capability for large animal research. The proposed design omitting
redundant HEPA filters will need to undergo review and approval by both USDA and CDC in
the context of a detailed agent- and procedure-specific risk assessment (including but not limited
to FMDv, Hendra virus, and Nipah virus).
It is still too early in the design process for the committee to verify and predict the
infrastructure’s capability for biocontainment. As the progress and specific installation and
implementation of sanitary and HVAC designs mature, the NBAF management will need to
assure mechanisms exist for continued engagement of professional engineers and qualified
consultants who have proven skills in high-biocontainment design and operation. The critical
engineering and construction plans will affect the containment potential for the life span of the
facility.
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.
There is a need to develop strong working relationships with the CDC, USAMRIID,
USDA, and National Institutes of Health to understand how the NBAF can work safely with
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dangerous zoonotic pathogens in large animals. There is a need for interdisciplinary research and
programmatic workshops that cross traditional agency boundaries. Such interagency working
relationships are often pragmatically difficult, but they are essential for minimizing risks and
putting in place mitigation strategies that can minimize the effects of a release from the NBAF.
CONCLUDING 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
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.
OCR for page 68
EVALUATION OF THE NBAF SITE-SPECIFIC RISK ASSESSMENT
68
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