Expertise and Capabilities: The committee was critical of the previous team contracted by NIH. The committee was encouraged to see the inclusion of personnel with experience in hospital infection control and infectious disease research, theory, and public health on the new team, as well as personnel who are already in touch with the Boston area public health surveillance system. The new team is also well connected to other networks of expertise that can be consulted if needed and has been working with NIH on developing a plan for identifying additional expertise should this be required. The presentations of the new team suggested that they understand the issues. However, the committee is concerned that the project staff is small and the schedule is tight. It will be important to provide the contractors with adequate resources to complete their work in the time proposed.

Qualitative Issues: The committee identified a few issues that it urges be considered in the qualitative assessments, and to the extent possible, in the models. The first is the need to focus on vulnerable populations where transmissibility and/or susceptibility may be higher, for example, among immunocompromised individuals. The second is the benefit of using a curve for infectious dose-response relationships, rather than relying solely on ID50 calculations. The limitations of use of points on the dose-response curve (e.g., ID50, ID10, ID1 ) should be clearly articulated.

Risk Communication: The committee continues to urge that the supplemental risk assessment be developed in recognition of the inevitable use of the document as a risk communication tool. To this end, it should be clear, accessible, and transparent to non-scientists, or be accompanied by a summary version that is comprehensive and easily accessible to the lay reader. In addition, the committee recommends that whenever possible, the final risk assessment clarify which findings are generalizable to other high-containment laboratories and those findings that are specific to the NEIDL, and why. Doing so could be valuable in informing future risk assessments for other facilities.

While pleased that the plans presented are consistent with the committee’s recommendations, the committee notes that these are plans. We await the results.

Finally, although the plans for analysis look appropriate, it is important that the assessors are flexible in applying and modifying their methods as any new information as well as analytical results become available.


A Committee Membership and Biographies

B March 19, 2010 Open Session Public Agenda

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