Meeting Critical Laboratory Needs for Animal Agriculture Examination of Three Options (2012) / Chapter Skim
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4 Analysis and Conclusions about Three Approaches for Providing US Infrastructure to Counter Foreign Animal Disease and Zoonotic Disease Threats
4 Analysis and Conclusions about Three Approaches for Providing US Infrastructure to Counter Foreign Animal Disease and Zoonotic Disease Threats
Pages 67-104
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From page 67... ...
Those options are building the National Bio- and Agro-Defense Facility (NBAF) as currently designed, building a version of the NBAF of reduced size and scope to be described by the committee, and maintaining the Plum Island Animal Disease Center (PIADC)
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From page 68... ...
Eleven years later, in 1994, USDA appointed a Task Force on Biocontainment Facilities for Foreign Animal Disease Research and Diagnostic Activities (USDA, 1994) to consider two issues: the progress made in the preceding decade in new technology development and use for handling FAD agents since the publication of the 1983 National Research Council report, and the current status of and physical requirements for large-animal biocontainment facilities for conducting FAD research and diagnostic activities in the near term and the longrange future.
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From page 69... ...
Continue to use existing FAD facilities on Plum Island until construction is completed on the mainland. Continue to conduct domestic disease and selected FAD work in separate mainland facilities" (USDA, 1994)
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From page 70... ...
, such as the National Animal Disease Center, the National Veterinary Services Laboratories, the Southeast Poultry Research Laboratory, and the Arthropod-Borne Animal Diseases Research Laboratory. Group Three -- Unacceptable Options Option 8: Upgrade Plum Island for foot-and-mouth disease work; contract other FAD work.
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From page 71... ...
THE LABORATORY INFRASTRUCTURE NEEDED FOR A FOREIGN ANIMAL DISEASE AND ZOONOTIC DISEASE RESEARCH AND DIAGNOSTIC FACILITY, REGARDLESS OF LOCATION AND SIZE A US system to address the potential threats posed by FADs and zoonotic diseases effectively must include the ability to conduct research and diagnostic procedures, provide training to support a competent and prepared workforce, and include specialized facilities for handling particular pathogens and for conducting experiments in large animals. The facility and program components of the ideal system are depicted in Figure 3-1, and a more detailed description of the laboratory infrastructure that would be required to meet those objectives is described below.
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From page 72... ...
NOTE: 1 = diagnostics, 2 = research on foot-and-mouth disease, 3 = research on non- foot-and-mouth disease FADs and zoonotic diseases in BSL-3Ag facilities, 4 = special pathogen activities in ABSL-4 and BSL-4 facilities, 5 = teaching and training, 6 = vaccine development. NAHLN = National Animal Health Laboratory Network; RBL/NBL = Regional Biocontainment Laboratories and National Biocontainment Laboratories.
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From page 73... ...
and the new genus of Henipavirus in the Paramyxoviridae family (Nipah and Hendra viruses) .2 BSL-4 laboratory capabilities are also needed more generally as part of an effective US system to counter FAD and zoonotic disease threats because of the possible emergence of new highly contagious zoonotic pathogens.
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From page 74... ...
Vaccine Development (6) Laboratory experiments as part of vaccine or other product development for FADs and zoonotic diseases (except for special pathogens)
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From page 75... ...
FAD research (non- foot-and-mouth disease) In vitro BSL-3/BSL-3E X X O O In vivo BSL-3Ag X X O (Continued)
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From page 76... ...
76 TABLE 4-1 Continued RBL/NBL Private National International NBAF as NBAF- BSL-3 BSL-3Ag Sector BSL-4 BSL-4 Components Designed Streamlined NAHLN Laboratories Academe Laboratories Laboratories Laboratories Zoonotic disease research BSL-3/BSL-3E X O X X BSL-4 X X X X Training using animals FADs except X O O X foot-and-mouth disease Vaccine development Development of principle X O O O O Proof of principle X O O O O Scale-up development X X Animal efficacy studies X X O NOTE: X = principal location, O = optional location.
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From page 77... ...
Activities that would be conducted in the proposed NBAF include studies of high-consequence FADs and zoonotic diseases that pose a threat to the US animal industry -- such as foot-and-mouth disease, African swine fever (ASF) , and classical swine fever (CSF)
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From page 78... ...
. Analysis of Option 1: Laboratory Capacity The NBAF as currently designed is meant to serve as a single facility to span the array of required biosafety containment levels and to include pilot-scale vaccine-development production capabilities, which would enable it to include all of the types of laboratory capability and capacity required for an ideal system as described above.
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From page 79... ...
Although the NBAF is designed to provide the range of required laboratory capabilities in a single facility, if it were to be operated in a stand-alone fashion without drawing on the nation's physical and intellectual capital, it would not meet the needs of an ideal US system to address FADs and zoonotic disease threats. However, the committee notes that building the NBAF as designed does not preclude the NBAF from functioning as part of such an integrated and collaborative system.
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From page 80... ...
Hence, the estimated number of full-time equivalent DHS and USDA research staff appears to be about 120. Estimated construction costs per gross ft2 of the main laboratory building range from $203 for general building support space to $1,197 for BSL4 space, with an average cost of $797 per gross ft2 for the whole facility.
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From page 81... ...
It was explicitly beyond the committee's charge to consider site locations of the proposed NBAF; the committee notes these issues only to the extent that they are related to its task to examine the relative costs of the three options that it was asked to discuss. Although the committee was not given detailed construction cost breakdowns for the proposed NBAF, the overall costs of construction appear to be much greater than costs of comparable recent construction of other biocontainment facilities, including those requiring BSL-4 containment space.
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From page 82... ...
. The proposed NBAF provides for such BSL3-Ag and ABSL-4 capacity, which is part of the infrastructure needed to achieve an integrated system to address FAD and zoonotic disease threats.
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From page 83... ...
Provides the United States with in-country infrastructure to address FAD and zoonotic disease threats. Avoids need for movement of specimens or materials derived from specimens to other facilities.
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From page 84... ...
Tables 3-1 and 3-2 list many of the US and international laboratories that have BSL-3Ag and BSL-4 capacity, which may provide opportunities for partnerships to supplement NBAF capacity. Relevant collaborations could include In vitro diagnostic work conducted in National Animal Health Laboratory Network (NAHLN)
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From page 85... ...
Areas outlined in red are those that the committee suggests could be eliminated or reduced in scope. SOURCE: Adapted from Johnson and Barrett, 2012.
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From page 86... ...
BSL-2 laboratory support space is required for in vitro research and development, including diagnostics. Although the NAHLN provides important diagnostic capacity to the country, an effective system to address FAD and zoonotic disease threats will nevertheless require that a central facility, such as the NBAF, support the network through confirmatory and reference diagnostics, reference reagent production, proficiency testing, and assay development.
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From page 87... ...
They included the possibility of reducing the angle of separation between the Auditorium wing and BSL-2 laboratory and office space, making the lobby smaller, and reducing the scale of the building landscaping. However, those types of design components are not central to the committee's charge to evaluate options for providing the needed laboratory infrastructure for a US system to protect against FAD and zoonotic disease threats, so it did not consider them further.
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From page 88... ...
To gain sufficient statistical significance for a challenge study, it is desirable that an experiment be done with as many animals as is practical. In the case of foot-and mouth disease vaccine challenge studies, the World Organisation for Animal Health (OIE)
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From page 89... ...
, there should be adequate flexibility in applying the above VSTA exemption provisions to establish efficacy data for foot-and-mouth disease vaccines and other vaccines intended solely for emergency use in the United States. For example, efficacy testing for foot-and mouth disease vaccine candidates could be done using the PPG test protocol recom mended by the OIE and doing challenge studies in groups of nine animals at a time (one control and eight vaccinates)
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From page 90... ...
A streamlined NBAF must function as part of an overall system that maintains the critical core competencies needed to address US FAD and zoonotic disease threats. In order to accomplish this goal, a streamlined NBAF would require the formation of collaborations with existing federal, university, and private sector laboratories to supplement its capacity.
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From page 91... ...
Total 110,885,000 a Net square footage reductions were estimated in various types of laboratory space on the basis of the NBAF 65% design plan presented by DHS (Johnson and Barrett, 2012) and additional net and gross square footage laboratory information provided to the committee (DHS, 2012b)
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From page 92... ...
Because it would continue to incorporate laboratory infrastructure at BSL-3Ag, BSL-4, and ABSL-4, it would continue to address the critical core needs of an ideal system for dealing with FAD and zoonotic disease threats identified by the committee. It would also still allow the consolidation of mission needs of DHS, ARS, and APHIS in a single location and meet the overall needs of countering disease threats to the nation.
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From page 93... ...
Makes more efficient use of recently expanded US laboratory capacity. Fosters greater collaboration and understanding between researchers as part of the integrated US system for countering FAD and zoonotic disease threats.
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From page 94... ...
Current Situation of Plum Island Animal Disease Center Capacity and Capabilities PIADC has a long history of serving the nation as the sole highbiocontainment laboratory for performing research and diagnostic investigations on foot-and-mouth disease and other FADs. A historical perspective of the role of PIADC in FAD work is presented in Appendix C
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From page 95... ...
. 8 The procedures for conducting investigations of potential foreign animal diseases are outlined in Veterinary Services Memorandum 580.4 (USDA, 2010)
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From page 96... ...
BSL-4 laboratories 0 13,400 BSL-3Ag and BSL-3E 72,400 81,100a laboratories BSL-2 laboratories 5,300 9,700 BSL-2 Biotechnology 0 8,300 Development Module Office and support space 65,000 63,500 SOURCE: Johnson and Barrett, 2012. a The proposed NBAF includes 37,460 net ft2 of BSL-3E and 53,925 net ft2 of BSL-3Ag laboratory space (including animal support)
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From page 97... ...
, successful international research cooperative agreements existed before the creation of PIADC to work with FMDv in several European laboratories, and this model could be replicated for the emergency use of ABSL-4 facilities until this critical capacity is available in the United States or as an emergency supplement to future US ABSL-4 large-animal capacity. 9 As indicated above, the committee does not agree with USDA and DHS statements that BSL-4 capabilities are required for unpacking diagnostic samples or for basic diagnostic procedures when nucleic acid detection technologies are used.
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From page 98... ...
, while longterm improvements are estimated at $210 million if PIADC is required to maintain its existing mission and to continue operating for another 25 years. Advantages and Liabilities of Option 3: The Plum Island Animal Disease Center PIADC is currently the only US facility that can provide several of the critical core functions of an integrated system to address FAD and zoonotic disease threats and is the only laboratory in the United States that is authorized to conduct research, diagnostics, and training related to foot-and-mouth disease.
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From page 99... ...
The overall advantages and liabilities considered by the committee are summarized in the lists of bulleted items below. Advantages Is an existing US facility that provides many of the laboratory infrastructure components needed and would avoid the costs of constructing a new replacement facility.
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From page 100... ...
Maintaining PIADC long term will continue to compound the difficulties in hiring new high-level scientists to work there due to the continued isolation of the national laboratory site from academic and other research and development centers. CONCLUSIONS ABOUT THE THREE OPTIONS As a result of its evaluation of the three options in its statement of task, the committee finds Option 1: The NBAF as currently designed includes all components of the ideal laboratory infrastructure in a single location and has been designed to meet the current and anticipated future mission needs of DHS, ARS, and APHIS; but the proposed facility also has drawbacks (Conclusion 1)
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From page 101... ...
Presentation at the Meeting on an Analysis of the Requirements and Alternatives for Foreign Animal and Zoonotic Disease Re search and Diagnostic Laboratory Capabilities, April 13, 2012, Washington, DC. DHS (Department of Homeland Security)
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From page 102... ...
1994. Final Report: Task Force on Biocontain ment Facilities for Foreign Animal Disease Research and Diagnostic Activities.
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From page 103... ...
580.4. Procedures for the Investiga tion of Potential Foreign Animal Disease/Emerging Disease Incidents (FAD/EDI)
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