Technical Input on Any Additional Studies to Assess Risk Associated with Operation of the National Emerging Infectious Diseases Laboratory, Boston University A Letter Report (2008) / Chapter Skim
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BACKGROUND
BACKGROUND
Pages 4-14
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is part of the National Institute of Allergy and Infectious Diseases efforts to provide physical infrastructure for the conduct of biodefense and emerging-infectious-disease research to develop new and improved approaches to treating, preventing, and diagnosing a variety of bacterial and viral diseases. Diseases to be studied include biothreat agents and emerging novel pathogens, such as those which cause Ebola, Marburg, plague, dengue fever, Lassa fever, shigellosis, and unusual virulent influenzas.
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An early task of the panel will be to advise NIH on the development of a statement of work for any risk analyses that may be necessary later. Given prior National Research Council comments on the DSRASSA, NIH also asked the Research Council to reconvene the Committee on Technical Input on the NIH's Draft Supplementary Risk Assessment and Site Suitability Analyses to obtain additional insights on scope and methodologies for future risk analyses from the NRC Committee.
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The NIH has now appointed a Blue Ribbon Panel to advise NIH on responding to judicial and public concerns about the siting and operation of the BU NEIDL and to recommend any additional risk assessment studies that may be needed. Given prior NRC comments on the DSRASSA, the NIH is asking the NRC Committee for input on any further supplementary risk assessments that NIH might undertake.
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Scientifically sound documents can help NIH address the public's concerns and provide information requested by the courts about site comparisons. Reviewing the scope and content of previous project documents is not within the committee's scope of work, but the committee is pleased to make suggestions about approaches for the blue ribbon panel to consider.
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. Scenarios for evaluating the risks posed by the NEIDL should systematically include potential realistic means of biological-agent escape and should describe the various safeguards to protect laboratory workers and the surrounding community.
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Including both BSL-3 and BSL-4 agents in any future risk assessments is appropriate because the reasons for studying a biological agent under BSL-3 vs BSL-4 conditions include factors other than the risk associated with release of an agent (BMBL 2007)
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The scenarios and agents discussed above should be used in any future risk assessments to analyze and communicate the probabilities of adverse events. The committee recommends that discussions of potential agent release include probabilistic statements regarding the three categories of release discussed above: • Procedural or work-practice failures, including those which lead to worker exposures and infections.
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An infectious agent release could have a variety of consequences, and an assessment should account for them. These consequences can be conceptualized as a continuum that ranges from few or no adverse outcomes (requiring minimal or no public health response)
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For example, the observation that there are "superspreaders", a small proportion of hosts that account for a large portion of the amplification of an epidemic, makes estimates of average transmission rates highly questionable. Likewise, it is difficult to estimate the number of contacts between people although recent estimates of age-specific contact rates from surveys that are relevant for respiratory spread of infectious diseases have become available for some populations (Mossong et al., 2008)
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A sensitivity analysis will help to rank parameter values according to the size of their effect on model output. As discussed in the qualitative description above, modeling approaches should also consider the impact of local conditions (for example, population density, vector availability, and public health infrastructure)
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also discuss risk communication in connection with laboratory siting. Finally, the committee refers the blue ribbon panel to the risk communication concepts discussed in the National Research Council reports Improving Risk Communication (1989)
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