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8 Evaluation of Biosafety Level 4 Assessment
Pages 69-78

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From page 69...
... An overall risk assessment of the NBAF BSL-4 would need to include an evaluation of the additive risks posed by all BSL-4 work, including the risk of a release from the BSL-4 associated with use of large animals in the BSL-4 suite, the risk of a release associated with non-animalrelated activities in the BSL-4 suite, and the risk of a release from the BSL-4 suite associated with natural disasters. The epidemiological and economic impacts of such a release would then need to be evaluated as part of the risk assessment.
From page 70...
... . The uSSRA states that the primary objective of the BSL-4 risk assessment is "to identify and characterize the unique risks associated with working with large animals in BSL-4 conditions." The analysis therefore focuses exclusively on risks associated with handling infected large animals in BSL-4 containment.
From page 71...
... The committee concurs that it is difficult, if not impossible, to model the risks associated with unknown agents. However, the uSSRA provides only a minimal risk estimate, and the present committee echoes the previous committee's concern that the risk assessment did not adequately discuss "the magnitude of risk and the strategy or process flow to identify and mitigate risk in future research areas" (NRC, 2010, p.
From page 72...
... The potential for natural disasters to affect the BSL-4 portions of the facility is not mentioned in the assessment of BSL-4 risks, and the committee wonders why the uSSRA fails to consider natural disasters as part of the BSL-4 risk assessment. Although the facility would be designed to withstand many natural disasters, there is a potential for loss of containment because of pressure fluctuations that can occur during a tornado or loss of structural integrity during an earthquake; this constitutes a significant omission and leads to an understatement of the risks associated with the BSL-4 containment suite.
From page 73...
... The uSSRA extrapolates the infectious dose in large animals and humans on the basis of weight. Allometric scaling is used in chemical risk assessment but is not an accepted practice in microbial risk assessment, in which the initial inoculum can replicate.
From page 74...
... The uSSRA discusses work that will be conducted at the NBAF to determine whether henipaviruses can infect North American bat species, and the committee concurs that such work is important. However, if henipaviruses affect native bat populations, this would affect the overall risk assessment and elevate the risk.
From page 75...
... Available information suggests that only emergency management officials in KDHE were contacted for the uSSRA. However, an unrecognized transference event involving human infection would require disease surveillance and diagnostic capacity that depend on KDHE epide
From page 76...
... The uSSRA uses simple calculations to determine the cost of a human life or the cost of a pig or horse to estimate economic impact, but the costs associated with even a single case would be far greater than suggested due to the nature of the pathogen and the national attention that would ensue. The committee thus finds that the outbreak impact scoring (which is a relative weighting given the lack of a full quantitative analysis)
From page 77...
... 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.


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