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Second NRC Committee Calls on NIH to Conduct Further Risk Assessment Studies for Proposed Boston BSL-4 Laboratory

By Jennifer Nuzzo, May 9, 2008

In an April 29, 2008, letter report, a National Research Council (NRC) Committee published recommendations from its second review of the proposed construction of the National Emerging Infectious Diseases Laboratory (NEIDL), a National Institutes of Health (NIH)-funded Biosaftey Level-4 laboratory at Boston University. According to the letter report, which was addressed to Director of the National Institutes of Health (NIH) Dr. Elias Zerhouni, the committee recommends the U.S. government conduct additional safety analyses of the proposed laboratory.¹

As reported by the Boston Globe, the NRC committee was first convened in 2007 to review the quality of the NIH’s risk assessment and site suitability analysis of the proposed laboratory. The recommendations stemming from that review, which were published in 2007, found that the original safety assessments of the laboratory that were conducted by the NIH were not “not sound and credible.”²

As previously reported in the Biosecurity Briefing, following the first review by NRC committee, the NIH created both an internal committee and a blue ribbon panel of experts to advise the NIH as to how to proceed with regard to the BSL-4 laboratory.³ In addition, Dr. Zerhouni requested that the NRC committee reconvene to provide him and the blue-ribbon panel with “further technical input on the scope and design of any additional studies that may be needed to assess risk associated with the siting and operation of the National Emerging Infectious Diseases Laboratory (NEIDL) at Boston University.”¹

Specifically, the second NRC committee was asked to “prepare a brief letter report summarizing its views on the scope (e.g., worst case scenarios, alternative sites, biosafety level-3 and -4 facilities, and selection of agents) and methodological approaches to be taken to improve any additional risk assessment studies that NIH prepares.” The NRC committee did not “review the content of previous documents (such as the original environmental impact statement or environmental impact report) or the scope of what has already been done to address risk and community concerns.” Rather, it “restricted its comments to suggestions” based only on its initial review of the NIH’s risk assessment and site suitability analyses.¹

The committee did not prescribe a set of “specific methods” for improving the NIH risk assessments, but rather elected “to structure its suggestions for the blue ribbon panel around a small number of overarching questions about the risks associated with operating the NEIDL.”¹ These questions are as follows:

What could go wrong?

• Scenarios of Release of an Infectious Agent. To address this question, the Committee recommends that the NIH conduct a two-phase analysis: 1) a “risk assessment based on a variety of plausible scenarios designed to allow a realistic assessment of risks associated with the NEIDL in general and to illuminate the comparative risks to the communities at the three sites evaluated in the DSRASSA [Draft Supplementary Risk Assessment and Site Suitability Analyses]; 2) an analysis of a “highly unlikely but still credible high-consequence event.”¹
• Agents to Consider for Risk Assessment. The Committee recommends that in conducting any future risk assessments, the NIH should “select a variety of agents with appropriately diverse transmission characteristics.” In addition, the Committee “believes that it may be helpful for NIH to clarify for the public and the courts what agents and forms of agents will not be researched at the NEIDL.”

What are the probabilities of such a sequence of events? “The committee recommends that discussions of potential agent release include probabilistic statements regarding the three categories of release [procedural or workpractice failures; biocontainment-system and equipment failures; and malevolent releases].”¹

What would be the consequences of such a sequence of events? Any mathematical models that are to be included in future risk assessments must be “done credibly, transparently, and to professional standards by an experienced team of epidemiological modelers and microbial risk assessors” and “should be interpreted in light of the strength of the data used to develop them.” The committee also recommended that “the NIH use the accumulated wisdom in the published literature on how to achieve effective risk communication.”¹

According to the Boston Globe, if the NIH follows the NRC committee’s recommendations it could result in further delays in the opening of the NEIDL. However, it is unknown how long it would take for the NIH to conduct an expanded review of the laboratory. NRC Committee Member Dr. Gigi Kwik Gronvall of the Center for Biosecurity of the University of Pittsburgh Medical Center told the Boston Globe that it was not part of the panel’s charge to consider how long it would take to implement the committee’s recommendations.²

References

1. National Research Council. 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). April 29, 2008. http://www.nap.edu/catalog.php?record_id=12208. Accessed May 9, 2008.
2. Smith S. Scientists call for biolab safety study. Boston Globe. May 3, 2008. http://www.boston.com/news/local/massachusetts/articles/2008/05/03/
   scientists_call_for_biolab_safety_study. Accessed May 9, 2008.
3. Cantu M. NIH establishes entities to address concerns about Boston biolab. March 14, 2008. Biosecurity Briefing. http://www.upmc-biosecurity.org/website/biosecurity_briefing/archive/science_biosecurity/
   2008-03-14-nihentitiesbostonbiolab.html. Accessed May 9, 2008.