1

Introduction

Safeguarding U.S. agriculture from foreign animal diseases1 and protecting our food system require cutting-edge research and diagnostic capabilities. The Department of Homeland Security (DHS) and the U.S. Department of Agriculture (USDA) have embarked on a mission to fulfill Homeland Security Presidential Directive 9 (HSPD-9) to enhance U.S. capabilities since that directive was issued by President George W. Bush in 2004. HSPD-9, Defense of United States Agriculture and Food, 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.” In response to HSPD-9, DHS plans to replace the aging Plum Island Animal Disease Center by constructing and operating a new facility, the National Bio- and Agro-Defense Facility (NBAF).

UNIQUE CAPABILITIES AND RISKS ASSOCIATED WITH THE NATIONAL BIO- AND AGRO-DEFENSE FACILITY

The NBAF is envisioned and designed as a state-of-the-art high-biocontainment facility that the nation and others would rely on for re-

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1 A foreign animal disease is an animal disease caused by a disease agent that does not occur naturally in the United States, with the disease limited to agricultural animals (NRC, 2005).



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1 Introduction Safeguarding U.S. agriculture from foreign animal diseases1 and pro- tecting our food system require cutting-edge research and diagnostic ca- pabilities. The Department of Homeland Security (DHS) and the U.S. Department of Agriculture (USDA) have embarked on a mission to fulfill Homeland Security Presidential Directive 9 (HSPD-9) to enhance U.S. capabilities since that directive was issued by President George W. Bush in 2004. HSPD-9, Defense of United States Agriculture and Food, 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 capa- bilities for foreign animal and zoonotic diseases.” In response to HSPD-9, DHS plans to replace the aging Plum Island Animal Disease Center by constructing and operating a new facility, the National Bio- and Agro- Defense Facility (NBAF). UNIQUE CAPABILITIES AND RISKS ASSOCIATED WITH THE NATIONAL BIO- AND AGRO-DEFENSE FACILITY The NBAF is envisioned and designed as a state-of-the-art high- biocontainment facility that the nation and others would rely on for re- 1A foreign animal disease is an animal disease caused by a disease agent that does not occur naturally in the United States, with the disease limited to agricultural animals (NRC, 2005). 9

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10 NBAF UPDATED SITE-SPECIFIC RISK ASSESSMENT search in and diagnostics of foreign animal diseases and zoonotic diseases.2 It would serve as a critical world reference laboratory for identifying emerg- ing and unknown disease threats and thus would be an important asset for securing the health, wealth, and security of our nation. As noted by the previous National Research Council committee that evaluated the DHS site-specific risk assessment (SSRA) in 2010, the planned NBAF would bring new capabilities and risks for the United States (NRC, 2010). First, locating the NBAF in Manhattan, Kansas, demonstrates an important U.S. policy and philosophy shift regarding the conduct of foot- and-mouth disease (FMD) research on the U.S. mainland. The United States has been free of FMD since 1929 (USDA-APHIS, 2007), and research on live FMD virus3 (FMDv) has not been permitted on the U.S. mainland since 19374 because it is a highly infectious viral disease of cloven-hoofed animals and constitutes a major threat to the livestock industry. Second, the NBAF would conduct substantial research and training activities with large animals that are infected with biosafety level 4 (BSL-4)5 pathogens, which would be important for understanding zoonotic diseases. Having BSL-4 capabilities for large animal research will be critical as new and un- known threats emerge. When operational, the NBAF would be the world’s fourth facility to have BSL-4 laboratories capable of large animal research: the others are in Geelong, Australia; Winnipeg, Canada; and Insel Riems, Germany. The one in Germany is undergoing laboratory commissioning as of this writing (Thomas Mettenleiter, Friedrich-Loeffler-Institut, personal communication, May 11, 2012). 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, thus preventing the efficient production of food animals and creating obstacles for the international trade of animals and animal products (WHO, 2012; IOM and NRC, 2009). 3 Foot-and-mouth disease virus is a BSL-3 agent. Biosafety in Microbiological and Biomedical Laboratories (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 FMDv) that present a risk of causing great economic harm if they infect the indigenous animal population (NRC, 2005). 4 In accordance with 21 USC Section 113a, live FMDv is not permitted on any part of the mainland of the United States unless the Secretary of Agriculture permits otherwise. 5 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).

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11 INTRODUCTION PROPOSED SITE IN MANHATTAN, KANSAS The proposed site of the NBAF is on the Kansas State University campus in Manhattan, Kansas, in Riley County. The NBAF will border the Biosecurity Research Institute and will be adjacent to the College of Veterinary Medicine. Kansas is in an area designated as Tornado Alley be- cause of its disproportionately high frequency of tornadoes (NOAA, 2012). Kansas is not especially prone to earthquakes, although the Humboldt Fault Zone runs east of Manhattan (USGS, 2012). The updated SSRA (uSSRA, p. 215) notes that the location selected for the NBAF is not susceptible to flooding. As acknowledged in the 2010 SSRA and the uSSRA, about 10% of the nation’s cattle population reside within a 200-mile radius of Manhat- tan, Kansas (USDA-NASS, 2009)—and approximately 45% of the nation’s cattle reside in the 7 states that were modeled as the expected impact area in the uSSRA (USDA-NASS, 2011)—which makes the region a major hub for transportation of cattle and other livestock for the entire United States. PREVIOUS ASSESSMENTS The site-selection process for the NBAF began in January 2006. DHS prepared an environmental impact statement (EIS) and a threat risk assess- ment for the six sites under final consideration (DHS, 2008). On the basis of those studies, DHS selected Manhattan, Kansas, as the location for the new NBAF in January 2009 (74 Federal Register, 2009).6 The Government Ac- countability Office subsequently raised concerns about the methods used in the EIS to determine risks for conducting FMDv research on the mainland and also found the EIS analyses to be flawed in determining the economic costs of an FMD outbreak (GAO, 2008, 2009). As a result, the FY 2010 DHS Appropriations Act (P.L. 111-83) mandated that DHS conduct a site-specific biosafety and biosecurity mitigation risk assessment (the 2010 SSRA) for the NBAF at the proposed Manhattan, Kansas, site; required the National Academy of Sciences (through its operating arm, the National Research Council) to independently evaluate the SSRA; and prohibited obligation of NBAF construction funds until the evaluation was complete. In 2010, a National Research Council report found that the SSRA had many legitimate conclusions but that it was not entirely adequate or valid, because of flawed methods and assumptions that underestimated the risks and economic costs associated with an accidental FMDv release from the Manhattan site (NRC, 2010). The findings of that report are presented in Box 1-1. 6 Available online at http://www.gpo.gov/fdsys/pkg/FR-2009-01-16/pdf/E9-914.pdf (accessed March 23, 2012).

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12 NBAF UPDATED SITE-SPECIFIC RISK ASSESSMENT Box 1-1 Findings of the 2010 National Research Council Review of the DHS Site-Specific Risk Assessment for the National Bio- and Agro-Defense Facility Finding 1: The SSRA lacks evidence to support the conclusion that the risk of re- lease that results in infection is very low relative to the risk of infection introduced from an external source. 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. Finding 3: The SSRA has several methodological flaws related to dispersion modeling, tornado assessment, and epidemiological modeling. Thus the commit- tee believes that questions remain about the validity of the overall risk estimates. 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. Finding 5: Substantial gaps in knowledge make predicting the course of an FMD outbreak very difficult, which led to weaknesses in the SSRA. Finding 6: Although the economic modeling was conducted with appropriate methods, the epidemiological estimates used as inputs to the SSRA were flawed. 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. 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. 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 biocontain- ment and biosecurity envelope. Finding 10: The committee agrees with the SSRA’s conclusion that investment in biosafety and biosecurity engineering and the training of personnel and re- sponders can reduce the risks, but is concerned about current design plans that potentially compromise safety measures. Finding 11: The SSRA’s qualitative risk assessment of work with BSL-4 pathogens in large animals was inadequate. SOURCE: NRC, 2010.

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13 INTRODUCTION CONGRESSIONAL MANDATE AND STATEMENT OF TASK As a result of concerns raised in the 2010 National Research Council review, the FY 2011 Department of Defense and Full-Year Appropriations Act (see Box 1-2) mandated that DHS revise its SSRA to address shortcom- Box 1-2 Department of Defense and Full Year Continuing Appropriations Act, 2011 Public Law 112-10, Sec. 1647. (a) Section 560 of Public Law 111-83 shall not apply to funds appropriated by this division. (b) No funding provided in this division shall be used for construction of the Na- tional Bio- and Agro-defense Facility until the Department of Homeland Security has, pursuant to the schedule submitted by the Department of Homeland Security on March 31, 2011, to the Committees on Appropriations of the Senate and House of Representatives— (1) completed 50 percent of design planning for the National Bio- and Agro- defense Facility, and (2) submitted to the Committees on Appropriations of the Senate and the House of Representatives a revised site-specific biosafety and biosecurity mitiga- tion risk assessment that describes how to significantly reduce risks of conducting essential research and diagnostic testing at the National Bio- and Agro-defense Facility and addresses shortcomings identified in the National Academy of Sci- ences’ evaluation of the initial site-specific biosafety and biosecurity mitigation risk assessment. (c) The revised site-specific biosafety and biosecurity mitigation risk assessment required by subsection (b) shall— (1) include a quantitative risk assessment for foot-and-mouth disease virus, in particular epidemiological and economic impact modeling to determine the overall risk of operating the facility for its expected 50-year life span, taking into account strategies to mitigate risk of foot-and-mouth disease virus release from the labora- tory and ensure safe operations at the approved National Bio- and Agro-defense Facility site; (2) address the impact of surveillance, response, and mitigation plans (de- veloped in consultation with local, State, and Federal authorities and appropriate stakeholders) if a release occurs, to detect and control the spread of disease; and (3) include overall risks of the most dangerous pathogens the Department of Homeland Security expects to hold in the National Bio- and Agro-defense Facility’s biosafety level 4 facility, and effectiveness of mitigation strategies to reduce those risks. (d) The Department of Homeland Security shall enter into a contract with the National Academy of Sciences to evaluate the adequacy and validity of the risk assessment required by subsection (b). The National Academy of Sciences shall submit a report on such evaluation within four months after the date the Depart- ment of Homeland Security concludes its risk assessment.

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14 NBAF UPDATED SITE-SPECIFIC RISK ASSESSMENT ings, required the National Academy of Sciences (through the National Research Council) to evaluate the uSSRA, and prohibited obligation of con- struction funds until the completion of another risk assessment. The scope for both the 2010 SSRA and the 2012 uSSRA addressed accidental release of pathogens from the NBAF in Manhattan, Kansas, and excluded terrorist acts and malicious threats from its risk assessments. This report represents the National Research Council’s response to the charge as elaborated and delineated in the committee’s statement of task (see Box 1-3). Box 1-3 Statement of Task The National Research Council will convene a committee of experts to review a congressionally mandated, updated site-specific risk assessment (SSRA) con- ducted by the Department of Homeland Security for the planned National Bio- and Agro-Defense Facility (NBAF) in Manhattan, Kansas. The Updated SSRA will be prepared in response to the Department of Defense and Full-Year Continuing Ap- propriations Act of 2011 (P.L. 112-10, Sec. 1647), which requires that it address concerns previously raised in an NRC review of the initial site-specific risk as- sessment for the NBAF, and requires that it describe risk reduction and mitigation strategies related to conducting essential research and diagnostic testing at the NBAF. DHS will provide the committee with a presentation on the contractor’s ap- proach for developing the work plan for the updated SSRA. Committee members and other meeting participants will discuss gaps in the DHS-presented approach, credible approaches and options to consider for the risk assessment, and areas where further technical input and assistance is needed. Based on those discus- sions, the committee will organize a workshop to include presentations with invited technical experts, and the workshop will serve as an information-exchange forum to address various issues raised by the DHS-presented approach. At a subse- quent meeting, DHS will provide draft sections of the updated SSRA for commit- tee members and other participants to discuss any remaining gaps or additional approaches to consider for the final updated SSRA. There will be discussion of issues from individual committee members and other participants, but no consen- sus advice will be provided from these open-session meetings. Following the completion of the final updated SSRA, the committee will review the document and prepare a report to DHS and Congress containing its findings on the adequacy and validity of the final updated SSRA. The report will be pro- vided to the sponsor within 4 months of receiving the final updated SSRA from DHS. 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 final updated SSRA.

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15 INTRODUCTION COMMITTEE’S APPROACH TO ITS TASK Information Gathering Meetings The National Research Council convened a committee of experts to evaluate the uSSRA for the NBAF in Manhattan, Kansas (see Appendix A for committee biosketches). On September 6–7, 2011, the committee orga- nized a workshop and invited experts to join the committee in discussing DHS’s proposed approaches for revising the SSRA. On November 8, 2011, DHS briefed the committee on the updated 65% design phase plans for the NBAF. On January 27, 2012, members of the committee held a meeting at Kansas State University in Manhattan, Kansas, to discuss the community’s expectations regarding collaborative research and preparedness with the NBAF and to hear comments from the public (see Appendix B for meeting agendas and attendees). Members of the committee also visited the pro- posed NBAF site and toured facilities at Kansas State University’s College of Veterinary Medicine and at the Biosecurity Research Institute. DHS delivered the uSSRA final report consisting of three volumes to the committee on February 10, 2012. The committee convened on March 16, 2012, in Washington, DC, to discuss it with DHS and its contractors. In March 2012, the committee submitted clarification questions to DHS, and DHS provided written responses and additional materials to the committee that are available as an addendum to the uSSRA. Process for Determining Adequacy and Validity The committee used various approaches in evaluating the adequacy and validity of the uSSRA. First, the committee examined whether the uSSRA’s methods and statements were consistent with and supported by current acceptable scientific thinking, methods, and findings. Second, for approaches in the uSSRA that were inconsistent with generally accepted practices or approaches and for approaches that had not been previously assessed through scientific peer-review and publication processes, the com- mittee exercised its judgment based on the quality of reasoning, soundness of logic, and strength of support in the existing body of scientific literature and knowledge. Third, the committee assessed the clarity and precision of the analysis provided in the uSSRA. Finally, the committee reviewed whether the uSSRA addressed shortcomings raised in the previous commit- tee’s evaluation (NRC, 2010).

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16 NBAF UPDATED SITE-SPECIFIC RISK ASSESSMENT Limitations of the Scope The statement of task outlines a narrow yet definitive scope for the committee’s report, which is limited to assessing the scientific adequacy and validity of the final uSSRA provided by DHS. It was beyond the purview and expertise of the committee to judge the selection of Manhattan, Kan- sas, as the site of the NBAF. In addition, the committee was not asked to provide its own risk assessment in the short 4-month timeframe provided for the review. ORGANIZATION OF THE REPORT In the remainder of the report, the committee evaluates the uSSRA and presents its findings and conclusions. Chapter 2 provides an evaluation of the NBAF designs, operations, and response planning. Chapter 3 examines the risk approaches and calculations used in the uSSRA. Chapter 4 evalu- ates the methods and assumptions provided in the uSSRA to model events that could lead to an accidental release. The committee assesses the meth- ods, assumptions, and analysis used in the uSSRA for the fate and transport model, the epidemic model, the economic model, and BSL-4 assessment in Chapters 5, 6, 7, and 8, respectively. Chapter 9 presents an overall assess- ment and includes the committee’s findings and conclusions. REFERENCES CDC (Centers for Disease Control and Prevention). 2009. Biosafety in Microbiological and Biomedical Laboratories. 5th Ed. Available online at http://www.cdc.gov/biosafety/ publications/bmbl5/BMBL.pdf (accessed March 22, 2012). 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 23, 2012). GAO (U.S. Government Accountability Office). 2008. High-Containment Biosafety Labora- tories: 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 23, 2012). 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 23, 2012). IOM (Institute of Medicine) and NRC (National Research Council). 2009. Sustaining Global Surveillance and Response to Emerging Zoonotic Diseases. Washington, DC: The Na- tional Academies Press. NOAA (National Oceanic and Atmospheric Administration). 2012. U.S. Tornado Climatol- ogy. Available online at http://www.ncdc.noaa.gov/oa/climate/severeweather/tornadoes. html (accessed March 22, 2012). NRC (National Research Council). 2005. Animal Health at the Crossroads: Preventing, Detecting, and Diagnosing Animal Diseases. Washington, DC: The National Academies Press.

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17 INTRODUCTION NRC. 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. Wash- ington, DC: The National Academies Press. 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 March 23, 2012). USDA-NASS (U.S. Department of Agriculture, National Agricultural Statistics Service). 2009. Quick Stats—Statistics by State, Livestock Inventory January 2009 Agricultural Statis- tical Annual. Available online at http://www.nass.usda.gov/Statistics_by_State/Kansas/ index.asp (accessed March 23, 2012). USDA-NASS. 2011. Agricultural Statistical 2011. Available online at http://www.nass.usda. gov/Publications/Ag_Statistics/2011/Chapter07.pdf (accessed April 30, 2012). USGS (U.S. Geological Survey). 2012. Kansas Earthquake Information: Earthquake Hazards Program. Available online at http://earthquake.usgs.gov/earthquakes/ states/?region=Kansas (accessed March 23, 2012). WHO (World Health Organization). 2012. Zoonoses. Available online at http://www.who.int/ topics/zoonoses/en/ (accessed March 23, 2012).

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