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National Research Council (US) Committee on Continuing Assistance to the National Institutes of Health on Preparation of Additional Risk Assessments for the Boston University NEIDL. Continuing Assistance to the National Institutes of Health on Preparation of Additional Risk Assessments for the Boston University NEIDL, Phase 3. Washington (DC): National Academies Press (US); 2011.

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Continuing Assistance to the National Institutes of Health on Preparation of Additional Risk Assessments for the Boston University NEIDL, Phase 3.

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BACKGROUND AND INTRODUCTION

In 2003, the Boston University Medical Center (BUMC) was awarded a $128 million grant from the National Institutes of Health (NIH) to build one of two national maximum-containment laboratory facilities for pathogen research. The National Emerging Infectious Diseases Laboratories (NEIDL) are meant to support the National Institute of Allergy and Infectious Diseases’ biodefense research agenda, conducting research to develop new approaches to treating, preventing, and diagnosing a variety of bacterial and viral diseases. Diseases and pathogens to be studied include viruses (e.g., Ebola, Marburg, dengue fever, Lassa fever, and highly pathogenic influenza) and bacteria (e.g., Shigella and plague) that occur naturally and cause infections or that could be used in deliberate attacks. The facility includes a biosafety level 4 (BSL-4) containment laboratory housed in a 192,000 square foot building. Although the NEIDL BSL-4 laboratory accounts for only 13 percent of the building’s total space, it has been the source of virtually all of the community concern surrounding this project. The location of the facility on Albany Street in Boston’s South End, which is an environmental justice community, (Boston Region Metropolitan Planning Organization, Journey to 2030; Loh, et al., 2002) has been controversial, and there have been numerous public meetings over the plans for the facility as well as three legal actions challenging the project. Construction of the laboratory building is now finished although commissioning of the laboratory facilities has not been completed. A remaining issue is whether the BSL-4 component will become operational.

The building, including the BSL-4 laboratory, is part of the BioSquare Phase II project. Under the Massachusetts Environmental Policy Act (MEPA), the Secretary of the Commonwealth of Massachusetts’s Executive Office of Environmental Affairs issued a certificate stating that the BioSquare II project required the preparation of an Environmental Impact Report (EIR). Although the Massachusetts Secretary of Environmental Affairs in 2004 found that the final Environmental Impact Report adequately and properly complied with MEPA, this determination was challenged in court. In July 2006 the Superior Court of Massachusetts vacated Massachusetts’ certification of the EIR and remanded the matter to the Secretary of Environmental Affairs.

NIH prepared a document, “Draft Supplementary Risk Assessment and Site Suitability Analyses” (DSRASSA), regarding the siting and operation of the NEIDL in response to comments from the federal court presiding over another lawsuit under the National Environmental Policy Act (NEPA) and to supplement NIH’s previous assessments of the potential risks posed by the NEIDL at its current location in Boston.

At the request of the State of Massachusetts, in November 2007 the NRC Committee authoring the current report released the first in a series of letter reports assessing the DSRASSA.3 The Committee’s assessment was critical of the DSRASSA, finding that it was not sound and credible, did not adequately identify and thoroughly develop worst-case scenarios, and did not contain the appropriate level of information to compare the risks associated with alternative locations. The report also raised specific concerns about agent selection, scenario development, modeling methodology, environmental justice issues, and risk communication.

In March 2008, NIH established its Blue Ribbon Panel (BRP) to provide scientific and technical advice to the NIH Director through recommendations made to the Advisory Committee to the Director. The panel members were charged with providing ongoing, expert input to guide the development of any necessary additional risk assessment analyses. Also in2008, the same NRC Committee reconvened at the request of NIH. The NRC Committee has been meeting with the BRP periodically as milestones were reached in the preparation of additional risk assessment materials. The NRC released its second letter report in April 2008.4 The Committee restricted its comments in that report to suggestions based only on its previous review of the DSRASSA and improving the risk assessments presented therein as input to any additional studies that may be needed to assess risk associated with the siting and operation of the NEIDL. As noted in its 2007 report, the Committee acknowledged and emphasized the need for biocontainment laboratories, including BSL-4 laboratories. However, the Committee’s view remained that the selection of sites for high-containment laboratories should be supported by detailed analyses and transparent communication of the available scientific information regarding possible risks.

In its 2008 report, the Committee refrained from prescribing specific methods and other details, electing instead to structure its suggestions to the NIH BRP around the following overarching questions that should be addressed in future reports about the risks associated with operating the NEIDL:

  • What could go wrong?

    Release scenarios for infectious agents

    Agents to consider for risk assessment

  • What are the probabilities that these scenarios will occur?
  • What would be the consequences if they did occur?

The Committee also recommended that NIH make greater use of the accumulated wisdom in the published literature on how to achieve effective risk communication.

In 2009 NIH asked the NRC to convene the NRC Committee again to provide input at key milestones in the development of the supplementary risk assessment through a series of letter reports (see full Statement of Task, below). The first milestone for which input from the NRC was requested was the development of plans for the supplemental risk assessment. On March 19, 2010 at a joint meeting of the NIH BRP and the NRC Committee, the two contractor groups selected by NIH to complete the supplemental risk assessment—Tetra Tech and its subcontractors from the University of Utah—made presentations on the proposed plans for the supplemental risk assessment. At NIH’s request, the NRC Committee focused its discussions of the proposed approaches on the following questions:

  1. Is the range of agents being studied appropriate?
  2. Is the approach to event sequence analysis appropriate?

    Will the method result in an adequate range of scenarios being considered and selected for analysis?

    Are the plans for analysis and expression of results appropriate?

  3. Is the modeling approach appropriate?

    Is the approach to initial infection sound?

    Are the criteria for and selection of models sound?

    Are the uses of the hybrid branching-compartment models and the extreme values analysis sound?

On the basis of this meeting, in April 2010 the NRC Committee delivered its third letter report.5 In that report, the Committee noted that it had heard about plans, but not yet results. In general, the NRC Committee found the proposed approaches to conducting the risk assessment suitable and well planned. The agents selected for analysis were appropriate and comprehensive, and the expertise available on and to the assessment team seemed strong. NIH and Tetra Tech appeared to recognize data limitations and the need for flexibility in study design. The Committee encouraged NIH and Tetra Tech to develop qualitative analyses (an explanation of the safety and risk profile) of all 13 pathogens on the list in a manner that is clear and accessible to the public. The Committee also suggested that the qualitative analyses in the body of the assessment be supplemented with results of quantitative modeling planned for five pathogens, with details provided in appendices. Further, the Committee encouraged NIH and Tetra Tech to rely on data that are available from existing case studies, public health surveillance of the surrounding communities, and release incidents, not only to support its models but also to provide a complete and understandable picture for the public. The NRC Committee again emphasized that the final risk assessment be able to serve as an effective risk communication tool.

On September 22, 2010, the NRC Committee again met in open session with the Blue Ribbon Panel to hear presentations by NIH’s contractors on the approaches they were taking to conduct the risk assessment. After reviewing the material presented at the meeting, the NRC Committee concluded that it could not endorse as scientifically and technically sound the illustrative analyses presented. At that time, the NRC Committee found that the analyses presented did not represent a thorough assessment of the public health concerns raised by the Committee in its previous reports. The Committee noted that the analytical results discussed were incomplete, work on additional analyses was still ongoing, and expressed the hope that the comments provided in that letter report6 would be helpful to NIH and the Blue Ribbon Panel as the remainder of the work to be performed was carried out.

In October of 2011, NIH provided a 1700 page “90 percent” draft of the revised risk assessment (RA) for the NEIDL to the NRC Committee for its review. (This is the penultimate draft of the document before it is released for public comment.) The Committee met in closed session on November 1, 2011 to compile its questions and comments for a discussion with the Blue Ribbon Panel and the NIH contractor team the following day, November 2. This letter report contains the NRC Committee’s written comments in response to that November 2 meeting.

Statement of Task for This Letter Report

As with the Committee’s previous two letter report of the same title, the statement of task for this letter report is as follows:

The NIH will engage the Committee on Technical Input on the NIH’s DSRASSA for the Boston University NEIDL at key milestones during the development of a draft supplementary risk assessment. The NRC and the NIH Blue Ribbon Panel (BRP) will meet together in public to discuss the developing draft report. Information contained in the draft risk assessment may include data on agents, models, and scenarios; preliminary modeling results; and quantitative and qualitative assessments. Documents reviewed and discussed at these meetings will be made available to the public. Following each meeting with the BRP, the NRC Committee in closed session will prepare brief letter reports on the preliminary results of the supplementary risk analyses, focusing on whether the analyses are scientifically and technically sound in general and whether they address the public health concerns previously raised by the NRC in its review of the July 2007 DSRASSA. These letter reports will be made available to the public. The Committee will also provide written comments on the draft supplementary risk assessment when that document is made available for formal public comment. The Committee will submit its findings in the form of a final letter report that will also be made available to the public.

Footnotes

3

NRC. Technical Input on the National Institutes of Health’s Draft Supplemental Risk Assessments and Site Suitability Analyses for the National Emerging Infectious Diseases Laboratory, Boston University: A Letter Report (2007). Available at: http://www​.nap.edu/catalog/12073.html.

4

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). Available at: http://www​.nap.edu/catalog/12208.html.

5

Continuing Assistance to the National Institutes of Health on Preparation of Additional Risk Assessments for the Boston University NEIDL, Phase 1: A Letter Report (2010)

6

Continuing Assistance to the National Institutes of Health on Preparation of Additional Risk Assessments for the Boston University NEIDL, Phase 2 (2010)

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