Blue Ribbon Panel to Advise on the Risk Assessment of the National Emerging Infectious Diseases Laboratories at Boston University Medical Center
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Blue Ribbon Panel to Advise on the Risk Assessment of the Charge Purpose The purpose of the Blue Ribbon Panel is to provide scientific and technical advice to the National Institutes of Health (NIH), through the Advisory Committee to the Director, as the agency responds to the comments and concerns voiced by the courts, the local community, the National Research Council, and the general public regarding the construction and operation of a national biocontainment laboratory at Boston University Medical Center. Background In 2003, following a peer-review process, Boston University Medical Center (BUMC) was awarded a grant from the National Institute of Allergy and Infectious Diseases (NIAID) for the construction of a national biocontainment laboratory (NBL), known as the National Emerging Infectious Diseases Laboratory (NEIDL), to provide essential infrastructure for congressionally mandated programs of biodefense research. The NBL will include biosafety level 2, 3, and critically needed biosafety 4 (BSL-4) research space. As a prerequisite to the facility’s construction, the Massachusetts Executive Office of Energy and Environmental Affairs required BU to prepare a Final Environmental Impact Report (FEIR) to satisfy the requirements of the Massachusetts Environmental Policy Act (MEPA). As a Federal agency, NIH is subject to the requirements of the National Environmental Policy Act (NEPA). In accord with NEPA, NIH completed a Final Environmental Impact Statement (FEIS) for the BU NBL in December 2005 and published a Record of Decision in February 2006. Public input and comments were solicited, received, and considered throughout the process. In preparing the Final EIS, the NIH thoroughly reviewed the possible impacts of the BUMC NEIDL on the public and the environment and concluded that the construction and operation of the BUMC NEIDL posed negligible risk to the community in which the laboratory was sited or to the surrounding communities. Construction of the BUMC NEIDL is underway at the BioSquare II Research Park on Albany Street in Boston, adjacent to the Boston University Medical Center. Under both State and Federal environmental policy laws, the public must be provided with an opportunity to review and comment on the assessments. In general, and in the specific context of commenting on the impact studies, some residents and community groups have raised objections to the construction of the BUMC NEIDL and to the analyses of potential environmental impact. Law suits were filed by citizens and public interest groups in State court (July 29, 2005) and Federal court (May 18, 2006). In response to specific concerns raised in Federal court, the NIH prepared a Draft Supplementary Risk Assessment and Site Suitability Analysis (DSRASSA) for the BUMC NEIDL. The DSRASSA focused on the potential impacts of the release of several BSL-4 agents into the community under various scenarios. The DSRASSA was released for public comment in July 2007. In July 2006, the Superior Court held that BUMC's FEIR failed to consider any “worst case” scenario that involved the risk of contagion arising from the accidental or malevolent release of a contagious pathogen from the BUMC NEIDL and that the FEIR failed to analyze whether the “worst case” scenario would be materially less catastrophic if the NEIDL were located in a feasible alternative location in a less densely populated area. The judge voided the Massachusetts Executive Office of Energy and Environmental Affairs’ (MEOEEA’s) approval of the FEIR, and the state agency required BU to submit a supplemental FEIR (SFEIR) to address these shortcomings. The MEOEEA asked the National Research Council (NRC) to analyze the DSRASSA because the state agency viewed the DSRASSA as potentially relevant to its decision making process. The NRC issued a report in November 2007 highly critical of the analytic approach used in the draft supplemental analysis. The NIH has decided to revisit the supplemental report and respond comprehensively to the public comments on the DSRASSA, including those from the NRC. This may require the identification and analysis of additional scenarios that can be used in assessing the safety of the BUMC NEIDL. Tasks The Blue Ribbon Panel will provide independent and scientifically based advice regarding the scope of any further supplementary risk assessments, including questions to be addressed, as well as infectious agents and clinical scenarios to consider. The Panel will be mindful of issues related to NEPA requirements, environmental justice, community liaison, and risk communication. Specifically the Blue Ribbon Panel will:
Meetings and Completion Date The Blue Ribbon Panel will be convened approximately six times during its tenure and will issue a final set of recommendations to the NIH Director through the Advisory Committee to the Director, NIH. Membership and Structure The Blue Ribbon Panel will be established as a Working Group of the standing Advisory Committee to the Director (ACD), NIH. The Panel’s recommendations will be conveyed to the NIH Director through the ACD. The Panel will have approximately 16 members and will be deemed to be properly constituted as long as it comprises experts in infectious diseases, public health and epidemiology, risk assessment, environmental justice, risk communications, biodefense, biosafety, and infectious disease modeling.
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