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Letter report
Letter report
Pages 1-27
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From page 1... ...
The specific questions to be addressed are as follows: § Determine if the scientific analyses in NIH Study are sound and credible; § Determine whether the proponent has identified representative worst case scenarios; § Determine, based on the study's comparison of risk associated with alternative locations, 1 The principal operating arm of the National Academy of Sciences and the National Academy of Engineering 2 Committee on Technical Input on the National Institutes of Health's Draft Supplementary Risk Assessments and Site Suitability Analyses for the National Emerging Infectious Diseases Laboratory, Boston University. Committee members and their backgrounds can be found in Attachment A
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Thus, the questions addressed by the Committee will solely pertain to the scientific adequacy of the risk assessment and other analytical methodologies used in the DSER and whether the report responds to the state's questions in a scientifically sound and credible manner. The Committee makes no findings or recommendations regarding the original Risk Assessment and Site Suitability Analysis document Biosquare Phase II, Boston Massachusetts.
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• Alternative sites: Massachusetts asked for analyses of feasible alternative locations for the biocontainment building, including at least one in an area less densely populated than the proposed location in Boston's South End. The supplemental analyses should also evaluate whether the potential public impacts of a pathogen release, including a "worst case" scenario, would be materially different if the biocontainment building were constructed in a feasible alternative location in a less densely populated area.
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In response to issues raised in a federal court proceeding regarding the NIH Final Environmental Impact Statement, the NIH completed additional reviews of the potential impacts of the BSL-4 laboratory. This report, published by NIH as the Draft Supplementary Risk Assessments and Site Suitability Analyses for the National Emerging Infectious Diseases Laboratory, Boston University (hereafter referred to as the Draft Supplemental Environmental Report, or DSER)
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Overall, the Committee believes the DSER has not adequately identified and thoroughly developed worst case scenarios. The DSER appears to have examined some of the agents identified by the community, but did not effectively examine highly infectious agents that would be of greater relevance to comparing the risks at the three sites.
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The Committee was also dissatisfied with the depth of exploration of public health and safety concerns about environmental justice communities impacted by the alternative site considerations. The DSER does not adequately consider the public health and safety impact of the NEIDL on Boston's South End, an environmental justice community, in comparing the risk associated with alternative locations for the laboratory.
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The list of possible scenarios generated by this means included: • A transportation accident with subsequent release of an infectious agent • A release of a vector-borne disease • A release of an infected arthropod • A laboratory incident concerning mislabeling of a specimen or stock culture • A release of a recombinant organism • A laboratory incident involving Ebola virus • A laboratory incident involving a poxvirus • An incident involving a school or school-aged children • An incident requiring transport of an infected patient The four scenarios examined in the DSER contained many of the elements in this list of public concerns. The Committee commends NIH for taking account of input from concerned citizens in its development of supplemental analyses, but this consultative process apparently led to the selection of agents that did not fully address the issues raised by the Secretary of Environmental Affairs.
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Selected Agents Should Have Higher Transmission Probabilities The DSER would have been more useful in supporting decision-making had it considered candidate infectious agents that have the potential to lead to large infection rates in an exposed human population. The three scenarios involving directly transmitted diseases (Ebola Hemorrhagic Fever, Monkeypox and Sabia Hemorrhagic Fever)
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• Site personnel security failure • Procedures (inadvertent infection of one or more laboratory staff) • Malevolent action Such data would be useful in selecting the biological agents, operating conditions, and circumstances to generate an appropriate range of release scenarios and their consequences for evaluation.
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Outcome May Not Have Been Sufficiently Influenced by Important Biological Factors Most importantly, the Committee was concerned that the model did not appear to recognize biological complexities and reflect what is known about disease outbreaks and other biological parameters. The Committee was also uncomfortable with the notion that an attempt to include "true-life complexity" in and of itself increases the value of a model.
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The analyses would be more convincing if the biological rationale were provided for the choices made about parameters and the impact of these choices had been explored with uncertainty and sensitivity analyses. The Committee was concerned that the DSER did not provide such analyses -- two different and well-established techniques for analyzing the strengths and limitations of both general and microbial risk assessments (Morgan and Henrion, 1990; Codex Alimentarius Commission, 1994; Burmaster and Anderson, 1994; Nauta, 2000)
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A comparison of risk must, therefore, take into account population differences between urban and rural sites in modeling infectious diseases known to behave differently in such different settings. The model results as presented in the DSER, however, do not seem to be sensitive to population density.
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is unlikely in the case of the South End of Boston inner city location. The Committee suggests that there may be a higher potential for aerosol transmission of disease in such crowded microenvironments where aerosol transmission between humans may be very important as a mechanism for the spread of contagious diseases (Nicas and Sun, 2006; Bridges et al., 2003; Tellier, 2006)
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Incomplete Exercise of Risk Analysis Methodology Ideally, this type of assessment would present information consistent with established quantitative microbial risk assessment (QMRA) methodology (e.g., Codex Alimentarius Commission, 1999; ILSI, 2000)
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For example, the prevalence of asthma, immunosuppressive diseases, and poor nutrition in the environmental justice community, in comparison to the Tyngsborough and Peterborough communities, may be expected to worsen disease morbidity and spread in the event of a biological agent release from the facility. Again, a sensitivity analysis of the model would help guide how these conditions could be useful in assessing population risk.
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Several Committee members are individuals experienced in risk communication, and the Committee is compelled to comment on several aspects of communication that could be improved by following risk communication criteria outlined in several NRC reports (e.g., Improving Risk Communication, NRC, 1989; Understanding Risk: Improving Decisions in a Democratic Society, NRC, 1996) and other resources.
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Dr. Ahearne's research interests include risk analysis, risk communication, energy analysis, reactor safety, radioactive waste, nuclear weapons, materials disposition, science policy, and environmental management.
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Dr. Harvill has served on several NRC committees, including the Committee on Methodological Improvements to the Department of Homeland Security's Biological Agent Risk Analysis.
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Ramsey Medal from the Decision Analysis Society for lifetime contributions to the field of decision analysis, and a recipient of the Outstanding Risk Practitioner Award from the Society for Risk Analysis. Jonathan Richmond is CEO of Jonathan Richmond and Associates, a biosafety consulting firm with a global clientele.
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His research deals with the epidemiology and population dynamics of infectious disease in humans as well as wild and domestic animal species. He has extensive experience of mathematical modeling in the context of infectious and parasitic disease control strategies (including the evolution of drug resistance)
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The questions addressed by the Committee will solely pertain to the scientific adequacy of the NIH Study. The specific questions to be addressed are as follows: § Determine if the scientific analyses in NIH Study are sound and credible; § Determine whether the proponent has identified representative worst case scenarios; § Determine, based on the study's comparison of risk associated with alternative locations, whether there is a greater risk to public health and safety from the location of the facility in one or another proposed location; The parties acknowledge and agree that the Committee's report will be limited to a technical review of the NIH Study, and the Contractor [NRC]
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We thank the following individuals for their review of this report: John Applegate, Indiana University John Bailar, The National Academies Kenneth Berns, University of Florida Genetics Institute David Franz, Midwest Research Institute Charles Haas, Drexel University Marc Lipsitch, Harvard University Stephen Ostroff, Pennsylvania Department of Health Peter Palese, Mount Sinai School of Medicine Bailus Walker, Howard University Catherine Wilhelmsen, The United States Army Medical Research Institute for Infectious Diseases Although the reviewers listed above have provided many constructive comments and suggestions, they were not asked to endorse the conclusions or recommendations, nor did they see the final draft of the report before its release. The review of this report was overseen by Ed Perrin, University of Washington, and John Samet, Johns Hopkins University.
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Klempner, M.D. Associate Provost for Research Boston University Medical Campus Director, National Emerging Infectious Diseases Laboratories Institute 10:15 Questions for Boston University 10:45 Break 11:00 Stakeholder Representative Comments David Ozonoff, MD, MPH (by telephone/ videoconference)
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. Some examples of errors include: • On page VI-10, the DSER states as an assumption that "0.9% of individuals will develop hemorrhagic disease [attributable to Rift Valley Fever]
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1994. Principles of good practice for the use of Monte Carlo techniques in human health and ecological risk assessments.
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1989. Improving risk communication.
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