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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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EVALUATION OF THE NBAF SITE-SPECIFIC RISK ASSESSMENT 58 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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EVALUATION OF THE NBAF SITE-SPECIFIC RISK ASSESSMENT 60 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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EVALUATION OF THE NBAF SITE-SPECIFIC RISK ASSESSMENT 62 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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EVALUATION OF THE NBAF SITE-SPECIFIC RISK ASSESSMENT 64 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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OVERALL ASSESSMENT, FINDINGS, AND CONCLUDING REMARKS 65 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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EVALUATION OF THE NBAF SITE-SPECIFIC RISK ASSESSMENT 66 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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OVERALL ASSESSMENT, FINDINGS, AND CONCLUDING REMARKS 67 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.

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EVALUATION OF THE NBAF SITE-SPECIFIC RISK ASSESSMENT 68 REFERENCES Anderson, I. 2008. Foot and Mouth Disease 2007: A review and lessons learned. London: The Stationery Office. Cannon, R.M., and M.G. Garner. 1999. Assessing the risk of wind-borne spread of foot-and- mouth disease in Australia. Environ Int 25:713-723. NRC (National Research Council). 2008. Department of Homeland Security Bioterrorism Risk Assessment: A Call for Change. Washington, DC: The National Academies Press. IOM (Institute of Medicine) and NRC (National Research Council). 2009. Sustaining Global Surveillance and Response to Emerging Zoonotic Diseases. Washington, DC: The National Academies Press. Schley, D., L. Burgin, and J. Gloster. 2009. Predicting infection risk of airborne foot-and-mouth disease. J R Soc Interface 6:455-462. Thurmond, M.C. 2003. Conceptual foundations for infectious disease surveillance. J Vet Diagn Invest 15:501-514. UK-HSE (United Kingdom Health and Safety Executive). 2007. Final report on potential breaches of biosecurity at the Pirbright site 2007. Available online at www.hse.gov.uk/news/archive/07aug/finalreport.pdf [accessed March 3, 2010].