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Suggested Citation:"1 Introduction." National Research Council. 2010. Evaluation of a Site-Specific Risk Assessment for the Department of Homeland Security's Planned National Bio- and Agro-Defense Facility in Manhattan, Kansas. Washington, DC: The National Academies Press. doi: 10.17226/13031.
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Suggested Citation:"1 Introduction." National Research Council. 2010. Evaluation of a Site-Specific Risk Assessment for the Department of Homeland Security's Planned National Bio- and Agro-Defense Facility in Manhattan, Kansas. Washington, DC: The National Academies Press. doi: 10.17226/13031.
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Suggested Citation:"1 Introduction." National Research Council. 2010. Evaluation of a Site-Specific Risk Assessment for the Department of Homeland Security's Planned National Bio- and Agro-Defense Facility in Manhattan, Kansas. Washington, DC: The National Academies Press. doi: 10.17226/13031.
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Suggested Citation:"1 Introduction." National Research Council. 2010. Evaluation of a Site-Specific Risk Assessment for the Department of Homeland Security's Planned National Bio- and Agro-Defense Facility in Manhattan, Kansas. Washington, DC: The National Academies Press. doi: 10.17226/13031.
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Suggested Citation:"1 Introduction." National Research Council. 2010. Evaluation of a Site-Specific Risk Assessment for the Department of Homeland Security's Planned National Bio- and Agro-Defense Facility in Manhattan, Kansas. Washington, DC: The National Academies Press. doi: 10.17226/13031.
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Suggested Citation:"1 Introduction." National Research Council. 2010. Evaluation of a Site-Specific Risk Assessment for the Department of Homeland Security's Planned National Bio- and Agro-Defense Facility in Manhattan, Kansas. Washington, DC: The National Academies Press. doi: 10.17226/13031.
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Suggested Citation:"1 Introduction." National Research Council. 2010. Evaluation of a Site-Specific Risk Assessment for the Department of Homeland Security's Planned National Bio- and Agro-Defense Facility in Manhattan, Kansas. Washington, DC: The National Academies Press. doi: 10.17226/13031.
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Suggested Citation:"1 Introduction." National Research Council. 2010. Evaluation of a Site-Specific Risk Assessment for the Department of Homeland Security's Planned National Bio- and Agro-Defense Facility in Manhattan, Kansas. Washington, DC: The National Academies Press. doi: 10.17226/13031.
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Suggested Citation:"1 Introduction." National Research Council. 2010. Evaluation of a Site-Specific Risk Assessment for the Department of Homeland Security's Planned National Bio- and Agro-Defense Facility in Manhattan, Kansas. Washington, DC: The National Academies Press. doi: 10.17226/13031.
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Suggested Citation:"1 Introduction." National Research Council. 2010. Evaluation of a Site-Specific Risk Assessment for the Department of Homeland Security's Planned National Bio- and Agro-Defense Facility in Manhattan, Kansas. Washington, DC: The National Academies Press. doi: 10.17226/13031.
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1 Introduction BACKGROUND In its 2002 report Countering Agricultural Bioterrorism: The Role of Science and Technology, a National Research Council (NRC) committee identified gaps in knowledge about foreign animal disease pathogens that reduced the reliability and timeliness of risk-assessment and risk-management decisions, and it determined that the ability to detect and identify some animal pathogens rapidly after introduction was inadequate (NRC, 2002). After the creation of the Department of Homeland Security (DHS), that issue was partly addressed by Homeland Security Presidential Directive 9 (HSPD-9), Defense of United States Agriculture and Food, which directs the Secretary of Agriculture and the Secretary of Homeland Security 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.” To meet its obligations under HSPD-9, DHS plans to construct and operate a new facility: the National Bio- and Agro-Defense Facility (NBAF). The planned NBAF is envisioned as a state-of-the-art high-containment facility that will support programs that the nation and others will turn to as a global reference, training, and research laboratory for foreign animal diseases.1 The improved facility will replace the aging Plum Island Animal Disease Center (PIADC) and will enable DHS and the U.S. Department of Agriculture to fulfill their critical missions of conducting basic and applied research in diagnostics, detection, vaccine development, and training. The NBAF will differ from other high-containment laboratories in that it will have the potential to carry out critical research on agents that pose serious threats to U.S. animal and human health by using large animals (such as cattle and swine) and will presumably lead in developing effective vaccines, therapeutics, and diagnostics for animal diseases, including genomics related to threat agents and zoonotic diseases. 2 It will also provide critical diagnostic capacity for identifying emerging foreign 1 A foreign animal disease is an animal disease caused by an agent that does not occur naturally in the United States. The disease is limited to agricultural animals (NRC, 2005). 2 A zoonotic disease or infection is transmissible between animals and humans, and is caused by a bacterial, viral, parasitic, or unconventional agent. Zoonoses are a public health concern. Many zoonoses also affect animal health and thus prevent the efficient production of food animals and create obstacles to international trade in animals and animal products (WHO, 2008; IOM and NRC, 2009). 9

EVALUATION OF THE NBAF SITE-SPECIFIC RISK ASSESSMENT 10 animal and zoonotic diseases and unknown threats. Thus, the NBAF will be an important asset in securing the economy, human and animal health, and the security of the nation, in addition to assessing potential threat agents, for decades to come. DHS began a site-selection process for the NBAF in January 2006. As part of its evaluation, DHS prepared an environmental impact statement (EIS) to model the potential extent of dispersal of foot-and-mouth disease virus (FMDv) and prepared a threat risk assessment (TRA) to estimate security risks for the six sites under consideration (DHS, 2008). In January 2009, DHS selected Manhattan, Kansas, as the site for the new NBAF (Federal Register, 2009). The Government Accountability Office (GAO) raised concerns about DHS’s analysis of the risks related to performing FMDv research on the mainland, faulted the EIS’s choice of a Gaussian plume model, and found DHS’s economic analysis flawed in that the EIS did not address domestic market impacts of an FMD outbreak (GAO, 2008, 2009). As a result of the differing views of DHS and GAO about the adequacy of the studies used in the selection of Manhattan, Kansas, as the site for the NBAF, the FY 2010 DHS Appropriation Act (P.L. 111-83) instructed DHS to complete a site-specific biosafety and biosecurity mitigation risk assessment (SSRA) associated with the proposed facility “which includes an integrated set of analyses using plume modeling and epidemiological impact modeling to determine the requirements necessary to ensure safe operation of the NBAF at the approved Manhattan, Kansas, site” (see Box 1-1). The legislation also directed DHS to work with the NRC to conduct an independent evaluation of the SSRA (see Statement of Task in Box 1-2) and prohibited the obligation of funds for NBAF construction before completion of the review. Box 1-1 Public Law 111-83: Department of Homeland Security Appropriations Act, 2010 Sec. 560. (a) None of the funds made available by this Act may be obligated for construction of the National Bio- and Agro-defense Facility on the United States mainland until 30 days after the later of: (1) the date on which the Secretary of Homeland Security submits to the Committee on Appropriations of the Senate and the House of Representatives a site-specific bio-safety and bio- security mitigation risk assessment, which includes an integrated set of analyses using plume modeling and epidemiologic impact modeling, to determine the requirements necessary to ensure safe operation of the National Bio- and Agro-defense Facility at the approved Manhattan, Kansas, site identified in the January 16, 2009, record of decision published in Federal Register Vol. 74, Number 11, and the results of the National Academy of Sciences’ review of the risk assessment as described in paragraph (b): Provided, That the integrated set of analyses is to determine the extent of the dispersion of the foot-and-mouth virus following a potential laboratory spill, the potential spread of foot-and-mouth disease in the surrounding susceptible animal population, and its economic impact: Provided further, That the integrated set of analyses should also take into account specific local, State, and national risk mitigation strategies; or (2) the date on which the Secretary of Homeland Security, in coordination with the Secretary of Agriculture, submits to the Committees on Appropriations of the Senate and the House of Representatives a report that:

INTRODUCTION 11 (A) describes the procedure that will be used to issue the permit to conduct foot-and-mouth disease live virus research under section 7524 of the Food, Conservation, and Energy Act of 2008 (21 U.S.C. 113a note; Public Law 110-246); and (B) includes plans to establish an emergency response plan with city, regional, and State officials in the event of an accidental release of foot-and-mouth disease or another hazardous pathogen. (b) With regard to the integrated set of analyses included in the mitigation risk assessment required under paragraph (a)(1), the Secretary of Homeland Security shall enter into a contract with the National Academy of Sciences to evaluate the mitigation risk assessment required by subsection (a)(1) of this section and to submit a Letter Report: Provided, That such contract shall be entered into within 90 days from the date of enactment of this Act, and the National Academy of Sciences shall complete its assessment and submit its Letter Report within four months after the date the Department of Homeland Security concludes the risk assessment. Box 1-2 Statement of Task In reaction to criticism from the Government Accountability Office (GAO), the FY 2010 DHS Appropriation Act (P.L. 111-83) prohibits the obligation of funds for construction of the new National Bio- and Agro-Defense Facility (NBAF) until the Secretary of Homeland Security undertakes a site-specific biosafety and biosecurity mitigation risk assessment for the Manhattan, Kansas site. Once DHS completes the risk assessment, the Congressional language mandates that the National Academy of Sciences provide an independent evaluation of the DHS analyses. Therefore, under the auspices of the Board on Life Sciences and the Board on Agriculture and Natural Resources, the National Research Council (NRC) will convene a committee of experts to review the DHS site-specific risk assessment. The committee will not perform an independent evaluation of the safety of the NBAF, but will restrict its findings to assessing the adequacy and validity of the site-specific risk assessment. DHS is currently conducting a source selection process for a contractor to manage the development of the risk assessment. Subsequent to the selection, the committee will undertake its first task to answer questions related to the selected contractor’s work plan brought to it by DHS. In this capacity, prior to the contractor beginning their modeling and risk assessment process early in 2010, the NRC Risk Assessment Committee will meet with DHS in order to review the contractor’s Work Plan for the Risk Assessment and answer questions from DHS related to the plan. The NRC Risk Assessment Committee will convene to review the contractor’s Work Plan and the questions provided by DHS and will provide a brief letter report to DHS in response to these questions within four weeks of this meeting. This brief letter report will not be available to the public until the second letter report of the NRC Risk Assessment Committee is available to the public. Following the delivery of the final Risk Assessment report by the performer to DHS, the committee will undertake its second task to review the finished site-specific risk assessment and prepare a second and final letter report containing its findings within four months of receiving the performer’s report from DHS.

EVALUATION OF THE NBAF SITE-SPECIFIC RISK ASSESSMENT 12 COMMITTEE’S APPROACH TO ITS TASK The National Research Council convened a committee of experts (see biosketches in Appendix A) to evaluate the SSRA of the planned NBAF in Manhattan, Kansas. In preparation for the SSRA, DHS submitted a draft work plan for the committee to review and 28 written questions for the committee to address. The draft work plan provided a general overview of the proposed methods and models that DHS and its contractors would use to conduct the SSRA. Preliminary Work Plan Advice The committee issued a preliminary letter report (see Appendix B) that reviewed the SSRA draft work plan, answered the 28 specific questions, and provided recommendations on how to improve the work plan. In considering the draft work plan, the committee recognized that the NBAF’s new location and new capabilities would introduce a new set of risks. The committee felt that the SSRA would have to account for site-specific biosafety and biosecurity mitigation strategies in addition to risk assessment. The committee believed that in planning for the NBAF and preparing for its eventual operation, the SSRA would need to inform about the potential risks of pathogen escape so that plans could be appropriately developed to reduce risk (such as modifications in facility engineering design and operation plans) and mitigate potential consequences. DHS initially proposed a narrow interpretation of the congressional mandate for an SSRA that would have focused almost exclusively on foot-and-mouth disease virus (FMDv) and plume modeling of an aerosol release. DHS revised the work plan to include risks posed by Rift Valley fever virus on the basis of discussions with the committee on February 25, 2010 (see Appendix C for meeting agendas). After reviewing the preliminary SSRA work plan, the committee recommended a much broader approach that would consider other agents and risks relevant to the NBAF, including zoonotic agents (FMDv rarely infects humans and is not a public health threat) and other infectious agents that may require biosafety level 4 (BSL-4)3 containment (FMDv is a BSL-3 agent4); the committee also recommended that other routes of release be considered (such as release via fomites, liquid waste, and solid waste) because recent cases have shown these routes to be major pathways of FMDv escape from laboratories (see Appendix B). The committee also recommended that the SSRA include a much broader view of indirect economic effects. A summary of the committee’s recommendations regarding the SSRA is provided in Box 1-3. DHS accepted the committee’s recommendations and included the proposed changes in the SSRA work plan. On June 7, 2010, the committee chairman conducted a briefing on the preliminary letter report for staff members of the U.S. House and Senate Committees on Appropriations. 3 Biosafety in Microbiological and Biomedical Laboratories (BMBL) states that “exotic agents that pose a high individual risk of life-threatening disease [in humans] by infectious aerosols and for which no treatment is available are restricted to high containment laboratories that meet biosafety level 4 (BSL-4) standards” (CDC, 2009). 4 BMBL states that BSL-3 is appropriate for “agents with a known potential for aerosol transmission, for agents that may cause serious and potentially lethal infections and that are indigenous or exotic in origin” (CDC, 2009). The BSL-3 agriculture (BSL-3Ag) designation is used for animal research facilities involving BSL-3 biological agents (such as foot-and-mouth disease) that present a risk of causing great economic harm if they infect the indigenous animal population (NRC, 2005).

INTRODUCTION 13 Box 1-3 Summary of Recommendations from Preliminary Letter Report The committee believes that the proposed work plan provided a reasonable framework but missed several fundamental issues related to the Manhattan, Kansas site and the unique requirements of a foreign animal and zoonotic disease facility. 1. The plan for the SSRA as outlined does not appropriately analyze potential pathways and will need to consider a better balance of other possible pathways of pathogen escape including, but not limited to, wastewater, fomites, and residual solid wastes. 2. The committee is concerned that the plan for the SSRA is limited to an examination of foot- and-mouth disease (FMD) and Rift Valley fever (RVF) viruses. 3. The SSRA will need to take into account the range of risk posed by working with the comprehensive suite of pathogens that are likely to be in the NBAF, including those at the BSL-4 level. FMD and RVF viruses do not represent the array of infectivity, vectors, hosts, environmental factors, and maximum credible risk scenarios that may result from emerging pathogens with unknown characteristics that require attention in the proposed high- containment facility. 4. The plan for the SSRA does not take into account the necessary laboratory training or management practices for establishing a competent, experienced, and credentialed workforce. 5. Mitigation strategies are not robustly or precisely addressed in the plan for the SSRA and will need to include other federal, state, county, and local officials to develop preparedness and response plans. 6. Determining the economic effects of an outbreak will require the SSRA to go beyond local market effects and include a national and international assessment that addresses additional commodities that would be affected by an outbreak. 7. Finally, to provide a more comprehensive and thorough SSRA, DHS and its contractors will need to consult additional subject matter experts, beyond those identified in the plan for the SSRA, to examine all the risk factors that need to be considered. Final Report and Discussions with DHS DHS and its contractors conducted the SSRA and delivered the report to the committee on June 30, 2010. The committee convened on July 13-14, 2010, in Washington, DC, to discuss the SSRA with DHS and its contractors (see Appendix C for meeting agendas). In attendance to answer questions related to the report were DHS officials and contractors that prepared the SSRA. During the open session of the meeting, the committee raised questions about the SSRA, and it submitted additional questions to DHS shortly thereafter. DHS delivered follow-up letters on July 28 and August 26, 2010; the latter follow-up letter provided a revised economic analysis, revised version of the SSRA’s chapter 5 with edits noted, and a revised discussion of risk posed by high-velocity winds (both follow-up letters are included in an appendix to the SSRA).

EVALUATION OF THE NBAF SITE-SPECIFIC RISK ASSESSMENT 14 Limitations of the Scope As outlined in the Statement of Task and as mentioned in the preliminary letter report (see Appendix B), it was beyond the committee’s purview to offer a judgment on the site location for the NBAF or to provide an interpretation of the SSRA for validating the site selection. The committee was restricted to assessing the adequacy and validity of the SSRA and was precluded from performing its own risk assessment. Accordingly, although the present NRC committee report discusses various aspects of the risk assessment, it contains no judgments about the wisdom of the selection of Manhattan, Kansas, as the site for the NBAF. This final report provides an evaluation of the SSRA and attempts to fulfill its two tasks: informing whether the risks were adequately and validly characterized for locating the NBAF in Manhattan, Kansas, so that Congress can make an informed judgment on the obligation of NBAF construction funds; and identifying ways for DHS to improve the biosafety and mitigation plans to ensure safe operations for the NBAF. NEW CAPABILITIES OF AND RISKS POSED BY THE NATIONAL BIO- AND AGRO- DEFENSE FACILITY Foot-and-Mouth Disease Virus Research on the Mainland The plan to locate the NBAF in Manhattan, Kansas, reflects an important change in both policy and philosophy related to conducting foreign animal disease programs that use infectious (live) agents (especially FMDv) on the mainland of the United States. In accordance with 21 U.S.C. Section 113a, FMD research has not been permitted on the U.S. mainland since 1937, because FMD is a highly infectious disease of cloven-hoofed animals that has major economic consequences for international trade. Since 1954, the nation’s foreign animal disease research and diagnostic programs have been conducted at the PIADC, which is on an island. Given the standard for infectious agent containment at that time, the original reasons for locating the facility on Plum Island were two-fold: first, the remote location would safeguard the country’s livestock health (Plum Island is nearly 2 miles off Orient Point on the northeast end of Long Island, New York, and there are no livestock on Plum Island outside the laboratory); and second, the remote location would be relatively secure for conducting research on disease agents (the only allowed means of accessing the PIADC are by ferry or helicopter). Important advances in high-containment laboratory design, equipment, and work practices have occurred in the last 5 decades and have enabled DHS to determine that work on foreign animal diseases, including FMD, can be safely conducted on the mainland (DHS, 2009). FMDv work on the mainland would constitute a dramatic change in U.S. policy—a change that favors long-term world-class advances in research, diagnostics, and disease-control technologies while fueling concerns with some people and organizations. Canada and other countries already have such mainland capability. The United States has been free of FMD since 1929 (USDA-APHIS, 2007). Because FMDv is the cause of major natural outbreaks in some parts of the world (Yang et al., 1999; Gibbens et al., 2001; Haydon et al., 2004; Anderson, 2008; Nishiura and Omori, 2010) and is housed in many international laboratories (OIE, 2009), there is a risk that it could be accidentally or intentionally introduced into the United States. NBAF will serve as the central U.S. asset in

INTRODUCTION 15 supporting preparedness for and response to such an event. FMDv is exceptionally infectious in cattle and swine, and so poses an extraordinary risk to the U.S. agricultural livestock economy. That is especially the case for Manhattan, Kansas, which lies at the heart of the beef cattle industry and close to the heart of the swine industry. The impact of an FMDv release, regardless of whether it be from the NBAF or introduced into the U.S. from another source, would potentially be very high. Therefore, it will be important to use every possible means to prevent an escape and to mitigate the consequences of an escape. High-Containment Work with Large Animals The NBAF is expected to support substantial research and training activities using large animals that are infected with foreign animal disease agents and zoonotic pathogens of interest. It would present a new opportunity for scientists and disease control officials in the United States to study FMD and zoonotic diseases in large animals, new capabilities that would carry site- specific risks. Many laboratories around the world work on FMD in large animals with various levels of containment (OIE, 2009). The NBAF would be the world’s third facility to have BSL-4 laboratories that can work with large animals; the other two are in Geelong, Australia, and Winnipeg, Canada.5 Research and training activities involving dangerous zoonotic pathogens in large animals will be new in the United States, and these activities are of great national economic, health, and security importance. However, the new capability for large animal work in BSL-4 rooms will pose unique risks that will need to be anticipated and prevented by appropriate facility design, modern biocontainment equipment and practices, and exceptional staff expertise and reliability. Only two zoonotic agents (Nipah virus and Hendra virus) have been considered in the SSRA for BSL-4 research with large animals, but it is clear that similar agents (including new agents and “unknowns”) will need to be considered for future programmatic development at the NBAF. Larger Experimental Animal Facilities NBAF design plans indicate that it will have more than twice as many gross square feet as the PIADC and will include more BSL-2, BSL-3, and BSL-3Ag areas. Table 2-1 of the SSRA states that the PIADC has 31,868 ft2 of BSL-3Ag space, compared with the planned 42,820 ft2 of BSL-3Ag space in the NBAF. It is important to note, however, that the PIADC space does not meet the standard for a BSL-3Ag facility, because the BSL-3Ag designation set out in the Biosafety in Microbiological and Biomedical Laboratories reference manual (CDC, 2009) was developed after the PIADC was built and the PIADC has only a single HEPA (high-efficiency particulate air) exhaust system. Work on zoonotic pathogens requiring BSL-4 biocontainment has not been conducted in the PIADC. The NBAF will include not only large animal research in BSL-4 conditions, but will also include a Good Manufacturing Practice (GMP) laboratory with BSL-3 capability for master seed production for vaccine development (page 25 of the SSRA). 5 The Australian Animal Health Laboratory (in Geelong) and the National Centre for Foreign Animal Disease (in Winnipeg) have set the standard for biocontainment of research and training activities involving dangerous zoonotic pathogens in large animals. That was done in concordance with long experience in BSL-4 laboratory work in several human disease laboratories, especially those at the U.S. Centers for Disease Control and Prevention (in Atlanta, Georgia) and the U.S. Army Medical Research Institute of Infectious Diseases (in Fort Detrick, Maryland).

EVALUATION OF THE NBAF SITE-SPECIFIC RISK ASSESSMENT 16 PROPOSED SITE IN MANHATTAN, KANSAS Proximity and Population Manhattan is in Riley County and is approximately 120 miles west of Kansas City. The Manhattan community occupies about 18 mi2 and has a population of about 50,000 (City of Manhattan, 2010). Kansas State University (KSU) is the largest employer and educator in Manhattan, with more than 23,000 students (KSU, 2010). The proposed site of the NBAF will be on the KSU campus immediately adjacent to the recently constructed Biosecurity Research Institute (BRI) and a short distance from the College of Veterinary Medicine’s research laboratories and teaching hospital. The BRI has state-of-the-art BSL-3, BSL-3 Enhanced (BSL- 3E), and BSL-3Ag research space. Major livestock operations and livestock transportation hubs are also nearby. Natural Hazards Kansas is in an area known as “Tornado Alley”, a region with a disproportionately high frequency of tornadoes (NOAA, 2008). The last major tornado to touch down in Manhattan was an EF4 tornado that occurred on June 11, 2008, and caused an estimated $20 million in damages at KSU and destroyed portions of the Wind Erosion Laboratory (KAKE, 2008). Kansas is not particularly prone to earthquakes, but some parts of the state are more earthquake-prone than others. A series of faults called the Humboldt Fault Zone runs through Riley County directly east of Manhattan (KGS, 1996, 2000). Manhattan was built on a floodplain just east of where the Kansas River and the Big Blue River intersect. The Big Blue River discharges its waters into Tuttle Creek Lake, the second- largest lake in Kansas, which is about 5 miles north of Manhattan (USACE, 2004). The Army Corps of Engineers is conducting a seismic retrofit of the Tuttle Creek Dam (USACE, 2004). With heavy precipitation, the area is prone to floods and flash floods. ORGANIZATION OF THE REPORT The remainder of this report presents the findings and conclusions of the committee’s evaluation. Chapter 2 examines site-specific risk and mitigation factors that should be considered for constructing and operating the NBAF in Manhattan, Kansas. Chapter 3 evaluates the methods used by DHS in the SSRA. Chapter 4 assesses the design plans and the plans for personnel preparedness, including the engineering and training needs to reduce the risk of a pathogen release from the NBAF and the effects if a release occurs. Chapter 5 presents the committee’s overall assessment and findings about the adequacy and validity of the SSRA, and concluding remarks for the Congress and DHS in moving forward.

INTRODUCTION 17 REFERENCES Anderson, I. 2008. Foot and Mouth Disease 2007: A Review and Lessons Learned. London: The Stationery Office. CDC (Centers for Disease Control and Prevention). 2009. Biosafety in Microbiological and Biomedical Laboratories. Fifth Edition. Available online at http://www.cdc.gov/biosafety/publications/bmbl5/BMBL.pdf [accessed July 26, 2010]. City of Manhattan. 2010. Manhattan, Kansas website. Available online at http://www.ci.manhattan.ks.us/index.aspx?NID=127 [accessed September 5, 2010]. DHS (U.S. Department of Homeland Security). 2008. National Bio and Agro-Defense Facility: Final environmental impact statement. Available online at http://www.dhs.gov/files/labs/gc_1187734676776.shtm [accessed March 3, 2010]. DHS. 2009. U.S. Department of Homeland Security with input from U.S. Department of Agriculture Response to the Government Accountability Office’s Draft Report (GAO-09- 747). Available online at http://www.dhs.gov/xlibrary/assets/nbaf_dhsresponse_gaoreport.pdf [accessed September 26, 2010]. Federal Register. 2009. Record of Decision for the National Bio- and Agro-Defense Facility Environmental Impact Statement: Department of Homeland Security, Science and Technology Directorate. Washington, DC: U.S. Government Printing Office. 74(11):3065-3080. Available online at http://edocket.access.gpo.gov/2009/pdf/E9- 914.pdf [accessed March 4, 2010]. GAO (U.S. Government Accountability Office). 2008. High-Containment Biosafety Laboratories: DHS lacks evidence to conclude that foot-and-mouth disease research can be done safely on the U.S. mainland. Washington, DC: GAO. Available online at http://www.gao.gov/products/GAO-08-821T [accessed March 4, 2010]. GAO. 2009. Observations on DHS’s Analyses Concerning Whether FMD Research Can Be Done as Safely on the Mainland as on Plum Island. Washington, DC: GAO. Available online at http://www.gao.gov/products/GAO-09-747 [accessed March 5, 2010]. Gibbens, J.C., C.E. Sharpe, J.W. Wilesmith, L.M. Mansley, E. Michalopoulou, J.B. Ryan, and M. Hudson. 2001. Descriptive epidemiology of the 2001 foot-and-mouth disease epidemic in Great Britain: the first five months. Vet Rec 149(24): 729-743. Haydon, D.T., R.R. Kao, and R.P. Kitching. 2004. The UK foot-and-mouth disease outbreak - the aftermath. Nature Reviews Microbiology 2:675-681. KAKE. 2008. KSU Estimates Tornado Damage at $20 Million. KAKE.com, local ABC affiliate. Available online at http://www.kake.com/home/headlines/19821509.html [accessed September 6, 2010]. KGS (Kansas Geological Survey). 1996. Earthquakes in Kansas. Available online at http://www.kgs.ku.edu/Publications/pic3/pic3_4.html [accessed September 6, 2010]. KGS. 2000. Earthquake Risk Low, But Real in Some Part of State. Available online at http://www.kgs.ku.edu/General/News/2000/earthquake.html [accessed September 6, 2010]. KSU (Kansas State University). 2010. About Kansas State University. Available online at http://www.k-state.edu/welcome/ [accessed September 5, 2010].

EVALUATION OF THE NBAF SITE-SPECIFIC RISK ASSESSMENT 18 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. Nishiura, H., and R. Omori. 2010. An Epidemiological Analysis of the Foot-and-Mouth Disease Epidemic in Miyazaki, Japan, 2010. Transboundary and Emerg Dis 57(6):396-403. NOAA (National Oceanic and Atmospheric Administration). 2008. U.S. Tornado Climatology. Available online at http://www.ncdc.noaa.gov/oa/climate/severeweather/tornadoes.html [accessed September 6, 2010]. NRC (National Research Council). 2002. Countering Agricultural Bioterrorism. Washington, DC: The National Academies Press. NRC. 2005. Animal Health at the Crossroads: Preventing, Detecting, and Diagnosing Animal Diseases. Washington, DC: The National Academies Press. OIE (World Organisation for Animal Health). 2009. Reference Experts and Laboratories. Available online at http://www.oie.int/eng/oie/organisation/en_listeLR.htm [accessed September 5, 2010]. USACE (U.S. Army Corps of Engineers). 2004. Tuttle Creek Dam Safety Assurance Program. Available online at http://www.nwk.usace.army.mil/projects/tcdam/fact-sheets.htm [accessed September 6, 2010]. USDA-APHIS (U.S. Department of Agriculture, Animal and Plant Health Inspection Service). 2007. Foot-and-Mouth Disease Factsheet. Available online at http://www.aphis.usda.gov/publications/animal_health/content/printable_version/fs_foot_ mouth_disease07.pdf [accessed September 5, 2010]. WHO (United Nations World Health Organization). 2008. Zoonoses. http://www.who.int/topics/zoonoses/en/ [accessed September 1, 2010]. Yang, P.C., R.M. Chu, W.B. Chung, and H.T. Sung. 1999. Epidemiological characteristics and financial costs of the 1997 foot-and-mouth disease epidemic in Taiwan. Vet Rec 145(25):731-744.

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Congress requested that the U.S. Department of Homeland Security (DHS) produce a site-specific biosafety and biosecurity risk assessment (SSRA) of the proposed National Bio- and Agro-Defense Facility (NBAF) in Manhattan, Kansas. The laboratory would study dangerous foreign animal diseases—including the highly contagious foot-and-mouth disease (FMD), which affects cattle, pigs, deer, and other cloven-hoofed animals—and diseases deadly to humans that can be transmitted between animals and people. Congress also asked the Research Council to review the validity and adequacy of the document. Until these studies are complete, Congress has withheld funds to build the NBAF.

Upon review of the DHS assessment, the National Research Council found "several major shortcomings." Based on the DHS risk assessment, there is nearly a 70 percent chance over the 50-year lifetime of the facility that a release of FMD could result in an infection outside the laboratory, impacting the economy by estimates of $9 billion to $50 billion. The present Research Council report says the risks and costs of a pathogen being accidently released from the facility could be significantly higher. The committee found that the SSRA has many legitimate conclusions, but it was concerned that the assessment does not fully account for how a Biosafety-Level 3 Agriculture and Biosafety-Level 4 Pathogen facility would operate or how pathogens might be accidently released. In particular, the SSRA does not include important operation risks and mitigation issues, such as the risk associated with the daily cleaning of large animal rooms. It also fails to address risks that would likely increase the chances of an FMD leak or of the disease's spread after a leak, including the NBAF's close proximity to the Kansas State University College of Veterinary Medicine clinics and KSU football stadium or personnel moving among KSU facilities.

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