Evaluation of a Site-Specific Risk Assessment for the Department of Homeland Security's Planned National Bio- and Agro-Defense Facility in Manhattan, Kansas (2010) / Chapter Skim
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Appendix B Preliminary Letter Report
Appendix B Preliminary Letter Report
Pages 77-126
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Appendix B Preliminary Letter Report1 1 The report that follows is the exact text of the Preliminary Letter Report provided on a privileged basis to DHS on March 26, 2010.
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APPENDIX B 79 Evaluation of a Site-Specific Risk Assessment for the Department of Homeland Security's Planned National Bio- and Agro-Defense Facility in Manhattan, Kansas: Preliminary Letter Report Committee on the Evaluation of a Site-Specific Risk Assessment for the Department of Homeland Security's Planned National Bio- and Agro-Defense Facility in Manhattan, Kansas Board on Life Sciences Board on Agriculture and Natural Resources Division on Earth and Life Studies THE NATIONAL ACADEMIES PRESS Washington, D.C.
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HSFLBP-10-C-00001 between the National Academy of Sciences and the U.S. Department of Homeland Security.
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APPENDIX B 81 The National Academy of Sciences is a private, nonprofit, self-perpetuating society of distinguished scholars engaged in scientific and engineering research, dedicated to the furtherance of science and technology and to their use for the general welfare. Upon the authority of the charter granted to it by the Congress in 1863, the Academy has a mandate that requires it to advise the federal government on scientific and technical matters.
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THURMOND, Professor Emeritus, University of California, Davis, CA STAFF PEGGY TSAI, Study Director and Program Officer CARL-GUSTAV ANDERSON, Senior Program Assistant FRANCES E SHARPLES, Director, Board on Life Sciences ROBIN A
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SHELTON-DAVENPORT, Senior Program Officer INDIA HOOK-BARNARD, Program Officer ANNA FARRAR, Financial Associate CARL-GUSTAV ANDERSON, Senior Program Assistant AMANDA P CLINE, Senior Program Assistant AMANDA MAZZAWI, Program Assistant
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MULLIGAN, Research Associate KAMWETI MUTU, Research Associate ERIN P MULCAHY, Senior Program Assistant
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Jahrling, National Institutes of Health, Frederick, MD Jonathan Richmond, Jonathan Richmond & Associates, Southport, NC Daniel L Rock, University of Illinois at Urbana-Champaign, Urbana, IL Gary Smith, University of Pennsylvania, Philadelphia, PA Akula Venkatram, University of California, Riverside, CA Ronald H
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This interim letter report contains the committee's responses to advise the DHS work plan for the site-specific risk assessment of the NBAF. The report contains several recommendations for consideration by the agency as it develops a more robust work plan and conducts its risk assessment for a new high-containment foreign animal disease laboratory.
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, 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".
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It is possible to identify and mitigate risks associated with infected animals on the basis of existing knowledge, but what remains unknown is the magnitude of risk and the strategy or process flow to identify and mitigate risk in future research areas. The SSRA will need to include contingency plans that minimize risk and mitigate maximum credible risk scenarios that could result from inadvertent or deliberate release of foreign animal or zoonotic disease agents from the facility.
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to determine the requisite design and engineering controls for the NBAF; inform the development of emergency response plans with city, regional, and state officials in the event after an accidental release of a pathogen; and assist in the development of the operational protocols needed to operate the facility safely and securely. Prior to the initiation of the planned SSRA, the Government Accountability Office (GAO)
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. The SSRA differs from the EIS in that this risk assessment will provide a more detailed analysis of the risks, impacts, and mitigation strategies related to the Manhattan site and thus will provide finer granularity than the EIS.
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The list of foreign animal diseases extends beyond the eight listed in the work plan; because the NBAF will be designed as a foreign animal and zoonotic disease research facility, additional foreign animal and zoonotic disease pathogens will need to be factored into the risk assessment. Whereas the full portfolio of pathogens need not be included in this SSRA, the SSRA should be broadened to consider the characteristics of all eight pathogens and other foreign animal and zoonotic disease pathogens and to address the types of unknown or emerging pathogens that the NBAF may study
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The SSRA should then focus on assessing the maximum credible risk scenarios related to the pathogens, including the potential impact and mitigation strategies for each scenario. The plan for the SSRA focuses almost exclusively on BSL-3-Ag issues.
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National Center for Animal Health Emergency Management. The current work plan lacks a critical component of risk communication (Reynolds, 2008)
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RESPONSES TO SPECIFIC QUESTIONS POSED TO THE COMMITTEE ABOUT THE DEPARTMENT OF HOMELAND SECURITY WORK PLAN Scenario Development Question 1.1: Accidental scenario selection: Do these eleven accidental release scenarios sufficiently describe the range of accidental releases that adequately bound the initial conditions for plume modeling, prospective epidemiological modeling, and economic impact assessments for the Site-Specific Risk Assessment (SSRA)
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Scenario development currently excludes local responders in their mitigation strategies and responses. For an entity to be registered with USDA to work with, possess, or transfer select agents, federal law requires it to address planning and coordination with local emergency responders in its incident response plan (7 CFR Part 331)
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Plume Modeling Question 2.1. Climatological datasets: Are there any other available climatological datasets that the NAS Committee would consider more appropriate for meeting the goals of this SSRA?
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models of airborne transmission in any comprehensive approach to modeling of the spread of FMDv within the United States and to use appropriate sensitivity analyses that recognize that the amount of theoretical airborne transmission possible, if any, remains unknown. Inclusion of both direct-transmission and indirect-transmission models and airborne models would begin to address a maximum credible event scenario, a scenario that assumes airborne transmission is possible.
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Indoor transport and dispersion models: Are there other indoor transport and dispersion models or means to estimate fire-induced temperatures and pressures that the NAS committee would consider more appropriate for this particular application? Response to 2.6: The committee believes that there should be a better explanation of the planned role of this modeling in the overall SSRA.
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A suburban profile is probably better to use than an urban profile that includes large, tall buildings and the effect of their turbulence wake. The committee reiterates that plume modeling should not be central to the SSRA.
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The North American Animal Disease Spread Model (NAADSM) and other models allow users to control the mechanisms of transmission and infection dose, but are particularly sensitive to expert opinion for the underlying assumptions and thus are vulnerable to the foibles of expert opinion.
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With the conglomerate of environmental affects on airborne microbial inactivation (such as humidity, temperature, and irradiance) , the bioaerosol literature cited in the SSRA work plan is tenuous (Barlow, 1972; Donaldson, 1972; Donaldson and Ferris, 1975; Donaldson et al., 1983; Nuanualsuwan et al., 2008)
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has been adopted by USDA's Center for Epidemiology and Animal Health because of its user-friendly interface, even though it has not been validated and may not be the best model for assessing spread and mitigation strategies. One study compared model spread predictions (Dube et al., 2007)
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Modeling of the contribution of wildlife: Is the proposed approach to assess the contribution of wildlife acceptable? If not, what changes are suggested to adequately consider the contribution of wildlife to an FMD outbreak to measure the utility of outbreak mitigation efforts?
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The modeling of outbreak-mitigation strategies requires substantial attention and involves a variety of physical, biological, and economic constraints. A risk assessment should take into account the optimization of mitigation under such constraints and should bound outcomes within the practically and reasonably available mitigation practices.
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Question 4.4. Trade ban timeframe: Economic studies specifically evaluating the impact of a domestic FMD outbreak differ in their assumptions of the length of the anticipated trade ban.
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Response to 4.4: The trade ban length of 45–60 days is too short. The OIE director general's comment assumes that the United States could regionalize as Brazil and Argentina have during recent FMD outbreaks.
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. The OIE Terrestrial Animal Health Code, in Articles 8.5.10–8.5.31, identifies importation guidelines for animals and animal products.
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Response to 5.1: The general order of items presented in the final report draft outline is acceptable. However, the contents of the draft report should be revised to address the committee's general concerns regarding the SSRA's pathways, pathogens and hosts, practices, mitigation strategies, and site-specific analysis.
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In its epidemiological model and mitigation strategy, the SSRA should also include the likelihood of eradicating and the time needed to eradicate infected vectors and infected animal reservoirs, such as cattle and sheep. Amendment Question 3: Robustness of prospective epidemiological RVF modeling: Overall, is this approach robust and evidence-based enough to adequately assess the effectiveness of risk mitigation strategies in this project?
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resulting from the introduction of RVF will be estimated parametrically from related economic impact studies of other zoonotic diseases (e.g., West Nile Virus, H5N1, H1N1)
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2002. Natural aerosol transmission of foot-and-mouth disease virus to pigs: minimal infectious dose for strain O1 Lausanne.
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2004. New directions: Airborne transmission of foot-and-mouth disease virus Atmospheric Environment 38(3)
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2007. The North American Animal Disease Spread Model: A simulation model to assist decision making in evaluating animal disease incursions.
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2008. Economic Impacts of Foreign Animal Disease.
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2001. Modelling the atmospheric dispersion of foot-and-mouth disease virus for emergency preparedness.
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2007. Rift Valley fever: Fact sheet no.
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Reasonable Maximum Credible Risk Worst-Case Scenario Outcomes 1. Assumptions a.
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1. Review of Best Practices, Mitigation Strategies, Risk Communication, and Emergency Response Plans at Domestic and International Sites 2.
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Reasonable Maximum Credible Risk Worst-Case Scenario Outcomes b. Reasonable Maximum Credible Risk Worst-Case Scenario Mitigation Strategy c.
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