1

Introduction

BACKGROUND

In 2004, President George W. Bush issued Homeland Security Presidential Directive 9 (HSPD-9),1 which “establishes a national policy to defend the agriculture and food system against terrorist attacks, major disasters, and other emergencies.” Among the key provisions of HSPD-9, the Secretaries of Agriculture and Homeland Security are called on to coordinate a federal effort to “expand development of current and new countermeasures against the intentional introduction or natural occurrence of catastrophic animal, plant, and zoonotic diseases.” This coordinated effort would address research and development related to new methods of detecting, diagnosing, and preventing foreign animal diseases (FADs)2 and zoonotic diseases.3 Such research and development activities would require “safe, secure, and state-of-the-art agriculture biocontainment laboratories” to conduct such work.

The United States currently has a network of federal, state, and university-based laboratories that conduct research and diagnostic activities on animal diseases. The laboratory network includes the Plum Island Animal Disease Center (PIADC), a federally-owned and operated facility on Plum Island, off the coast of Long Island, New York. PIADC is the only laboratory in the United States in which foot-and-mouth disease virus can be studied; foot-and-mouth disease is a highly contagious FAD that affects cloven-hoofed animals and has potentially catastrophic agricultural and economic consequences. The United States has been free of foot-and-mouth disease since 1929. For more than 50 years, PIADC has conducted research and diagnostic activities on foot-and-mouth disease and other foreign animal diseases. Similar research on the most highly contagious

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1 Available online at http://www.aphis.usda.gov/animal_health/emergency_management/downloads/hspd-9.pdf (accessed May 30, 2012).

2 Foreign animal diseases are caused by animal disease agents that do not occur naturally in the United States and that affect agriculturally important animals (NRC, 2005).

3 Zoonotic disease agents can be transmitted between animals and humans (IOM and NRC, 2009).



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1 Introduction BACKGROUND In 2004, President George W. Bush issued Homeland Security Presidential Directive 9 (HSPD-9),1 which “establishes a national policy to defend the agri- culture and food system against terrorist attacks, major disasters, and other emergencies.” Among the key provisions of HSPD-9, the Secretaries of Agricul- ture and Homeland Security are called on to coordinate a federal effort to “ex- pand development of current and new countermeasures against the intentional introduction or natural occurrence of catastrophic animal, plant, and zoonotic diseases.” This coordinated effort would address research and development re- lated to new methods of detecting, diagnosing, and preventing foreign animal diseases (FADs)2 and zoonotic diseases.3 Such research and development activi- ties would require “safe, secure, and state-of-the-art agriculture biocontainment laboratories” to conduct such work. The United States currently has a network of federal, state, and university- based laboratories that conduct research and diagnostic activities on animal dis- eases. The laboratory network includes the Plum Island Animal Disease Center (PIADC), a federally-owned and operated facility on Plum Island, off the coast of Long Island, New York. PIADC is the only laboratory in the United States in which foot-and-mouth disease virus can be studied; foot-and-mouth disease is a highly contagious FAD that affects cloven-hoofed animals and has potentially catastrophic agricultural and economic consequences. The United States has been free of foot-and-mouth disease since 1929. For more than 50 years, PIADC has conducted research and diagnostic activities on foot-and-mouth disease and other foreign animal diseases. Similar research on the most highly contagious 1 Available online at http://www.aphis.usda.gov/animal_health/emergency_manageme nt/downloads/hspd-9.pdf (accessed May 30, 2012). 2 Foreign animal diseases are caused by animal disease agents that do not occur natu- rally in the United States and that affect agriculturally important animals (NRC, 2005). 3 Zoonotic disease agents can be transmitted between animals and humans (IOM and NRC, 2009). 13

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14 CRITICAL LABORATORY NEEDS FOR ANIMAL AGRICULTURE zoonotic agents that also infect livestock species has not been conducted at PIADC, because of its focus on the highest-priority animal diseases (such as foot-and-mouth disease) and its lack of biosafety level 4 (BSL-4) containment areas, which are necessary for studying deadly zoonotic diseases that have no known treatment or cure. Examples of BSL-4 pathogens include Nipah and Hendra viruses. HSPD-9 allows the Department of Homeland Security (DHS) to expand its efforts in protecting the country against intentional or natural occurrences of FADs and zoonotic diseases. The aging facilities at PIADC and the lack of BSL-4 capac- ity prompted DHS to propose the creation of a National Bio- and Agro-Defense Facility (NBAF) in 2006. The proposed facility is designed to replace PIADC. It would carry out the current mission of PIADC and expand that mission to include the study of zoonotic diseases in BSL-4 and in animal biosafety level 4 (ABSL-4) large-animal containment for accommodating livestock species. According to DHS, the NBAF would provide “capabilities to perform basic and advanced research; enhanced means to perform laboratory diagnostic detec- tion and response; expanded capabilities for development of new vaccines against high-threat foreign animal diseases; and facilities for training veterinari- ans in preparedness and response to high-consequence foreign animal disease outbreaks” (DHS, 2012, pp. ES-2-ES-3). DHS now estimates that it would cost $1.14 billion to construct the NBAF in Manhattan, Kansas.4 THE COMMITTEE’S TASK Given the estimated cost of constructing the proposed NBAF and the coun- try’s current fiscal challenges, DHS requested that the National Research Coun- cil assess the disease threats to US animal and public health, describe the labora- tory capabilities needed to address the threats, and analyze three proposed options to meet those needs. The three options as stipulated by DHS are (1) con- structing the NBAF as designed, (2) constructing a scaled-back version of the NBAF, and (3) maintaining current capabilities at PIADC and leveraging BSL-4 laboratory capacity (for livestock) by using foreign laboratories. The statement of task is provided in Box 1-1. The National Research Council convened an ad hoc committee to conduct a scientific assessment of the requirements for an FAD and zoonotic disease re- search and diagnostic laboratory facility in the United States (see Appendix A for committee biosketches). The committee members have expertise in animal diseases, animal health, zoonotic disease threats to public health, the livestock industry, national security aspects of agriculture, agricultural economics, bio- safety, biosecurity, and laboratory biocontainment. 4 Estimate provided in the opening remarks to the committee by Tara O’Toole, US Department of Homeland Security Under Secretary for Science and Technology. Open- ing remarks were given at the committee meeting held on April 13, 2012, in Washington, DC.

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INTRODUCTION 15 BOX 1-1 Statement of Task A committee of experts will conduct a scientific assessment of the requirements for a foreign animal and zoonotic disease research and diagnostic laboratory facility in the United States. Specifically, the committee will: 1. Assess the threat posed to livestock by infectious diseases, such as zoonoses, current and emerging diseases, and bioterrorist agents. For this effort, the committee will rely upon a literature review of relevant articles and reports address- ing foreign animal diseases, agricultural bioterrorism, emerging and zoonotic dis- eases. DHS and USDA will provide relevant materials to assist the committee. 2. Identify the US laboratory and related infrastructure needed to counter the threat and meet the animal health, public health, and food security needs of the United States. 3. The committee will examine alternative approaches to providing the needed infrastructure, focusing on three options:  Building the NBAF as currently designed;  Building a scaled-back version of the NBAF (to be described by NRC/NAS);  Maintaining current capabilities at PIADC while leveraging BSL-4 labora- tory capacity (for livestock) through foreign laboratories. In evaluating alternatives, the committee will examine factors such as capacity and capabilities, advantages and liabilities, relative costs, and other considerations in relation to the mission needs of DHS and USDA (Agricultural Research Service and Animal and Plant Health Inspection Service) to counter the known and emerging threats from bioterrorism, foreign animal diseases and zoonotic diseases. The committee’s report will identify pros and cons, discuss potential gaps, and provide consensus advice on how the laboratory infrastructure needed to address emerging foreign animal and zoonotic disease threats could be assembled. The committee’s examination will address the capability needed to counter the identified threat, relative to the three options. The committee will not consider spe- cific site locations as part of this examination. The Committee’s Approach to Its Task The committee was given three months to complete its task. As part of its information-gathering activities, the committee held its first meeting on April 12-14, 2012, in Washington, DC. At the meeting, representatives of DHS and the US Department of Agriculture (USDA) briefed the committee on their ra- tionale and expectations for the study, and DHS indicated that it intended to use the findings and conclusions of the committee’s report to inform its decision- making process. DHS and USDA discussed the scientific programs at PIADC and those planned for the NBAF and briefed the committee on the current infra- structure and operating costs of PIADC and on the mission requirements, build-

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16 CRITICAL LABORATORY NEEDS FOR ANIMAL AGRICULTURE ing designs, and construction costs of the proposed NBAF in Manhattan, Kansas. The committee invited outside experts to speak about the capabilities and capacities of laboratories that would be similar to the NBAF. These included the Biosecurity Research Institute at Kansas State University in Manhattan, Kansas; the Centers for Disease Control and Prevention in Atlanta, Georgia; the National Centre for Foreign Animal Disease in Winnipeg, Canada; the Frie- drich-Loeffler-Institut in Insel Riems, Germany; and the Australian Animal Health Laboratory in East Geelong, Victoria, Australia (see Appendix B for meeting agendas). In gathering additional information about current US capabilities and infra- structure for handling FADs and zoonotic diseases, the committee arranged pub- lic teleconferences with the directors of three additional laboratories in the United States: the National Biodefense Analysis and Countermeasures Center of DHS, the US Army Medical Research Institute for Infectious Diseases, and the Rocky Mountain Laboratories of the National Institute of Allergy and Infectious Diseases (see Appendix B for the teleconference agendas). The committee also discussed the capabilities and capacities of representative regional laboratories. The second committee meeting was held on May 22-23, 2012, in Irvine, California, and was closed to the public in its entirety. The purpose of the meet- ing was to finalize the committee’s findings and conclusions and prepare its report for external peer review. Limitations of the Scope of the Committee’s Task As part of its task, the committee assessed the threats to US livestock by current and emerging diseases, including zoonoses, and identified the specific requirements for a high-biocontainment laboratory where these diseases could be diagnosed and studied. The scope of the committee’s analysis was limited to examining the three proposed options and whether each would have the capabil- ity of adequately addressing the current and future needs for conducting research and diagnostic activities related to FAD and zoonotic disease threats. Although the committee was required to focus its analysis on the three proposed options, it acknowledges that other viable options are available but it was prohibited from providing an in-depth analysis of the feasibility of other alternatives in this report. The statement of task also explicitly prohibits the committee from consider- ing specific site locations as part of its examination of the three options. Al- though the committee was asked to provide a comparison of the three options, it was beyond the committee’s charge to compare risks between the proposed NBAF in Manhattan, Kansas (on the US mainland) and the PIADC on Plum Island, New York (off the coast). Whether foot-and-mouth disease research can be safely conducted on the US mainland is an issue of considerable debate (GAO, 2008, 2009). A separate National Research Council committee recently

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INTRODUCTION 17 evaluated the adequacy and validity of an updated DHS site-specific risk as- sessment of the NBAF in Manhattan, Kansas. That committee concluded that the updated risk assessment was “technically inadequate in critical respects” and that it remains “an insufficient basis on which to judge the risks associated with the proposed NBAF in Manhattan, Kansas” (NRC, 2012). In providing an analy- sis of the three proposed options in this report, it is beyond the scope of this committee’s task to discuss or provide judgment on whether foot-and-mouth disease research can be safely conducted on the mainland or where such re- search should take place. The committee examined general design specifications as related to the re- search and diagnostic capabilities of the NBAF as currently proposed. The committee was asked to examine the NBAF as currently designed and to exam- ine a scaled-back alternative, but it was beyond the committee’s task to conduct a detailed building design review or cost analysis. ORGANIZATION OF THE REPORT The report is composed of five chapters. Chapter 2 provides an overview of the threats posed by infectious diseases to US agriculture and human health. Chapter 3 describes an ideal system for addressing FADs and zoonotic diseases, the role of a central laboratory facility (such as an NBAF-type of laboratory) in a national system, and current capacity and capabilities and future needs for ad- dressing FADs and zoonotic diseases in the United States. Chapter 4 analyzes the proposed options and discusses whether they provide the necessary infra- structure for effectively protecting animal health, public health, and food secu- rity against FAD and zoonotic disease threats in the United States. The commit- tee elaborates on its conclusions and recommendation in Chapter 5. REFERENCES DHS (US Department of Homeland Security). 2012. NBAF Updated Site-Specific Bio- safety and Biosecurity Mitigation Risk Assessment. Final Report, Vol. 1, February 2012 [online]. Available: http://www.dhs.gov/xlibrary/assets/st/nbaf_updated_ssra_ volume_i.pdf (accessed May 30, 2012). GAO (US Government Accountability Office). 2008. High-Containment Biosafety Labo- ratories: DHS lacks evidence to conclude that foot-and-mouth disease research can be done safely on the U.S. mainland. Washington, DC: GAO [online]. Available: http://www.gao.gov/products/GAO-08-821T (accessed May 14, 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 [online]. Available: http://www.gao.gov/products/GAO-09-747 (accessed May 14, 2012). IOM (Institute of Medicine) and NRC (National Research Council). 2009. Sustaining Global Surveillance and Response to Emerging Zoonotic Diseases. G.T. Keusch, M. Pappaioanou, M.C. Gonzalez, K.A. Scott, and P. Tsai, eds. Washington, DC: The National Academies Press.

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18 CRITICAL LABORATORY NEEDS FOR ANIMAL AGRICULTURE National Research Council (NRC). 2005. Animal Health at the Crossroads: Preventing, Detecting, and Diagnosing Animal Diseases. Washington, DC: The National Acad- emies Press. NRC. 2012. Evaluation of the Updated Site-Specific Risk Assessment for the National Bio- and Agro-Defense Facility in Manhattan, Kansas. Washington, DC: The Na- tional Academies Press.