Earlier chapters of this report examined the literature on the risk of infectious disease in US livestock production, identified the capabilities necessary to counter disease threats and protect the food supply and public health, and explored the strengths and weaknesses of three scenarios for providing laboratory functions relative to the identified capabilities. This chapter analyzes the options in light of the broader context of the Department of Homeland Security’s (DHS’s) need for advice on how to assemble the laboratory capacity to protect the food supply and animal agriculture from the threat of infectious disease. In providing this analysis, the committee has taken into consideration the current budget realities of DHS and other federal agencies, factors that drive costs of laboratory construction and operation, assumptions about what is possible and what is acceptable with regard to the three proposed scenarios, and its findings regarding the resources that are available to enhance the nation’s current capacity to safeguard animal health, public health, and food security.
As this and previous NRC reports describe, threats to US agriculture from foreign animal diseases (FADs), zoonotic diseases, and emerging diseases are growing, and it is imperative to establish research, diagnostic, and surveillance laboratory capabilities commensurate with the size and value of the US animal agriculture industry to prevent or mitigate a disease outbreak that could have devastating effects on human and animal lives and livelihoods. The committee finds that the country’s laboratory infrastructure is lacking in several ways, but especially with regard to modern biosafety level 3 agriculture (BSL-3Ag) and biosafety level 4 (ABSL-4) large-animal containment capabilities, which are among the critical core functions of a national system. The proposed National Bio- and Agro-Defense Facility (NBAF) as currently designed is envisioned as a high-biocontainment laboratory that could serve to provide such capabilities within a national system, but the proposed facility also has drawbacks.
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5 Overarching Conclusions and Recommendation Earlier chapters of this report examined the literature on the risk of infec- tious disease in US livestock production, identified the capabilities necessary to counter disease threats and protect the food supply and public health, and ex- plored the strengths and weaknesses of three scenarios for providing laboratory functions relative to the identified capabilities. This chapter analyzes the options in light of the broader context of the Department of Homeland Security’s (DHS’s) need for advice on how to assemble the laboratory capacity to protect the food supply and animal agriculture from the threat of infectious disease. In providing this analysis, the committee has taken into consideration the current budget realities of DHS and other federal agencies, factors that drive costs of laboratory construction and operation, assumptions about what is possible and what is acceptable with regard to the three proposed scenarios, and its findings regarding the resources that are available to enhance the nation’s current capac- ity to safeguard animal health, public health, and food security. As this and previous NRC reports describe, threats to US agriculture from foreign animal diseases (FADs), zoonotic diseases, and emerging diseases are growing, and it is imperative to establish research, diagnostic, and surveillance laboratory capabilities commensurate with the size and value of the US animal agriculture industry to prevent or mitigate a disease outbreak that could have devastating effects on human and animal lives and livelihoods. The committee finds that the country’s laboratory infrastructure is lacking in several ways, but especially with regard to modern biosafety level 3 agriculture (BSL-3Ag) and biosafety level 4 (ABSL-4) large-animal containment capabilities, which are among the critical core functions of a national system. The proposed National Bio- and Agro-Defense Facility (NBAF) as currently designed is envisioned as a high-biocontainment laboratory that could serve to provide such capabilities within a national system, but the proposed facility also has drawbacks. 105
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106 CRITICAL LABORATORY NEEDS FOR ANIMAL AGRICULTURE In presenting the agency’s study request to the committee on April 13, 2012, DHS Under Secretary O’Toole noted that although DHS remains con- vinced of the need for the NBAF, the source of funds to construct it has yet to be identified. She pointed to cuts of 53% in DHS’s science and technology division budget, the many competing needs in the agency (for both facilities and re- search), the general fragility of the national economy, and the collapsed real- estate value of the Plum Island property, whose sale was once envisioned as a source of revenue for building the NBAF. At the same time, DHS Under Secretary O’Toole noted that given the high stakes of the threat of animal disease for the large US agricultural economy, not providing an adequate laboratory infrastructure could also be very costly in the long run. That assessment provided a context for the work of the committee, which set about examining the two proposed alternatives to the NBAF as cur- rently designed. ANALYSIS OF THE THREE OPTIONS The Plum Island Animal Disease Center (PIADC) is currently the only US facility that can provide many but not all of the capabilities necessary for a cen- tral national laboratory as part of the US system for addressing FAD and zoono- tic disease threats. However, it has no capacity for ABSL-4 large-animal work, and its BSL-3Ag space is currently considered substandard. The committee was informed by DHS that adding ABSL-4 capacity to PIADC would not be possi- ble, given the need for political and local acceptance of zoonotic disease work on Plum Island. Even if continued renovations of such laboratory space at PIADC were con- templated, it might not ultimately increase the utility of the facility. PIADC is aging and increasingly inefficient, and there is a relatively high annual cost as- sociated with continually renovating and maintaining it. That cost could be a drain on the system in the long term, and funds might be better placed in sup- porting disease surveillance or diagnostic development and research. Inasmuch as PIADC is the only facility permitted to work on foot-and-mouth disease virus (FMDv), the committee finds that an alternative facility with BSL-3 Enhanced (BSL-3E) and BSL-3Ag laboratory space will be needed to continue that re- search. However, because foot-and-mouth disease research remains critical for the US animal health system, the committee concludes that it will be essential to support PIADC until an alternative facility is authorized, con- structed, commissioned, and approved for work with FMDv (Conclusion 4). In evaluating the PIADC alternative, the committee spent a considerable amount of time examining the need for ABSL-4 large-animal laboratory space, how it would be used, and how much of it would be needed. Chapter 3 points out that although by definition none of the livestock-specific FADs requires
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OVERARCHING CONCLUSIONS AND RECOMMENDATION 107 BSL-4 laboratory containment, a disease outbreak of a highly contagious zoono- tic virus or a novel pathogen of undetermined transmissibility in US livestock would require appropriate biocontainment on an emergency basis. Research to characterize the infectious agent, validation of diagnostics, and studies of patho- genesis, virulence, shedding, transmission, and host range and susceptibility would need to be investigated in live animals. As the committee explored the potential of relying on international partners for emergency work that might require ABSL-4 large-animal laboratory space, it found remarkably little capacity near the United States. In fact, space limitations at the Canadian biocontainment facility in Winnipeg, Manitoba, have resulted in a project to expand the capacity for ABSL-4 large-animal containment there. The committee notes that it is in the interest of the United States to actively pur- sue partnerships with countries that have ABSL-4 large animal laboratories to study known zoonotic agents of agricultural concern. However, given the uncer- tainty over priorities of a foreign laboratory and logistical difficulties in an emergency, it would not be desirable for the United States to rely on interna- tional laboratories to meet ABSL-4 large-animal needs in the long term. There- fore, as part of the national infrastructure for protecting animal and public health, the committee concludes that there is an imperative to build ABSL-4 large-animal space in the United States (Conclusion 5). A key question is whether cost savings would be realized by reducing the scope and capacity of an NBAF and performing some functions elsewhere. As noted in Chapter 4, the committee was provided limited and insufficient infor- mation to assess the actual costs of this scaled-back option (which included re- ductions in the currently planned space for building support and BSL-3Ag, BSL- 3E, and BSL-4 space). The DHS staff asserted that any redesign of the current plan for the NBAF, even a reduction in size, would add to its cost. The commit- tee was surprised that DHS had no contingency plan for a building of reduced size in the event of budget cuts. Moreover, the committee found a sizable dis- crepancy between costs projected for constructing the proposed NBAF and costs associated with other recently constructed biocontainment facilities. The com- mittee did recognize that part of the discrepancy in construction costs results from the recommendations to “harden” the proposed facility because of con- cerns about the building's structural integrity for the proposed site. But there is not a good estimate of operating costs for the streamlined scenario. A partnership of a central national laboratory of reduced scope and size and a distributed laboratory network could effectively protect the United States from FADs and zoonotic diseases, potentially realize cost savings, reduce redundan- cies, and enhance the cohesiveness of a national system of biocontainment labo- ratories. However, because the cost implications of reducing the scope and ca- pacity of a central facility cannot be known without further information and study, it will be important for DHS to make a good-faith effort to re-examine construction and operating costs of a laboratory of reduced size and complexity.
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108 CRITICAL LABORATORY NEEDS FOR ANIMAL AGRICULTURE CONSIDERATIONS FOR FULFILLING NATIONAL NEEDS Realizing cost savings in the construction and operation of laboratory facili- ties is a critically important objective. However, it is no less important for DHS, the US Department of Agriculture (USDA), and other relevant agencies to main- tain their focus on the overarching goal of developing a highly capable system for addressing FAD and zoonotic disease threats. A central laboratory would be a key part of an integrated national system, but it would only be one component of the system; therefore the committee concludes that innovative, forward- thinking solutions are required not only about the central laboratory but about the entire system (Conclusion 6). The solutions for the entire system may need to involve consideration of a wider range of options for the central laboratory. That analysis extends beyond the scope of the current study. As described in previous chapters, the ideal system to counter threats from FADs and zoonotic diseases includes research, development, and training; a centralized core facility; a distributed network of national and international part- nerships; and disease surveillance, diagnostic, and response capabilities. In ex- ploring national capabilities, the committee found a substantial number of public and private biocontainment laboratories across the country; these are capabilities that did not exist nearly a decade ago when Homeland Security Presidential Di- rective 9 was issued. Chapter 3 provides a map and a list of institutions that house a variety of BSL-3, BSL-3Ag, and BSL-4 laboratories in the United States. It is reasonable to view those facilities as potential partners in a national system and to expect that those existing capabilities can be leveraged in the na- tional interest. The major barriers to leveraging capabilities at those facilities are the need to establish formal relationships, agreed-upon operational protocols, contractual funding arrangements, and well-reasoned policies about the kind of work that can be conducted in different facilities. Yet in the committee’s view, it is precisely those kinds of relationships that could move the nation closer to the ideal, integrated national system to address animal disease threats—one in which a distributed laboratory network is tied closely to a central supporting facility. Regardless of the options considered for a central facility, the com- mittee recommends that DHS and USDA develop and implement an inte- grated national strategy that utilizes a distributed system for addressing FAD and zoonotic disease threats (Recommendation). The National Animal Health Laboratory Network (NAHLN) is an excellent model of such a distrib- uted network of laboratories and would serve a critical role in a more compre- hensive and integrated national strategy. Balanced Support for Infrastructure and Research and Development The committee concludes that it is critical for policy-makers and agen- cy planners to recognize that an effective system for addressing FAD and zoonotic disease threats to the United States consists of more than facilities;
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OVERARCHING CONCLUSIONS AND RECOMMENDATION 109 it also requires robust research programs (Conclusion 7). Those cannot be traded off against one another; rather, balanced support is needed to sustain re- search priorities and capital costs associated with maintaining or constructing modern laboratory facilities. The United States is fortunate to have significant physical and intellectual assets, both in government and in universities, which could be better used and coordinated to support a national research strategy. In deciding the best path forward, it will be critical for DHS and USDA to consider a holistic approach for developing solutions, one that strikes a balance between facilities costs and the research and development effort needed to protect Amer- ican agriculture and public health. Ongoing Planning and Prioritizing for the National System The committee concludes that conceptualizing, implementing, and maintaining a US national system to address threats posed by FADs and zoonotic diseases requires not only an understanding of today’s priorities and technologies but continued monitoring and assessment to understand how the high-priority threats and the tools available to address them change over time. Such vision and planning are critical and must be ongo- ing (Conclusion 8). There is a related need for continuing communication and coordination among the many parties and stakeholders that form an efficient, effective, and integrated national system. The central facility network of na- tional laboratory partnerships will require coordination not only in selecting national disease priorities and determining how those priorities should evolve, but in establishing the practical agreements and other details that would enable such a system to function. One possible mechanism to address some of those needs may be the establishment of a council that engages key stakeholders and is analogous to the model of the NAHLN Coordinating Council. Alternative Funding Mechanisms The committee concludes that exploring alternative funding mecha- nisms to supplement current federal allocations for capital and operational costs and for program support would be useful (Conclusion 9). Alternative funding strategies used by other countries could be considered as possible mod- els. For instance, Australia draws on industry contributions to help support its national animal disease capabilities. It may also be useful to explore the possi- bility of using public-private partnerships to support and maintain aspects of facilities and research programs. Consideration of All Factors of Concern The importance of having a strong national system to recognize and counter the threats posed by FADs and zoonotic diseases may not always be apparent
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110 CRITICAL LABORATORY NEEDS FOR ANIMAL AGRICULTURE when disease outbreaks are quickly identified, mitigated, and contained, but the consequences of such disease outbreaks can be enormous if and when a system fails. This study provides a high-level view of whether each of the three options stipulated by DHS could be feasible in meeting the nation’s needs. As discussed in Chapter 4, the committee also recognizes that the three DHS-proposed op- tions may not be the only options worth considering. Concerns considered in this study—costs, necessary capabilities, and infrastructure needs—do not re- flect all of the factors decision-makers must consider. The factors that were con- sidered in the original assessment that led to decisions about the NBAF may or may not have changed. For example, safety concerns still linger on the issue of bringing foot-and-mouth disease research onto the US mainland and the risk of accidental release of FMDv and its consequent impacts (NRC, 2010, 2012). De- cisions about infrastructure needs should not be made in the absence of risk con- cerns as well as the many other factors worthy of consideration. The committee concludes that to most appropriately fill critical laboratory needs in the United States, all factors of concern (including site location, risk assess- ment, political considerations, adaptability for the future) will need to be considered in a more comprehensive assessment (Conclusion 10). REFERENCES NRC (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. 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.