Blue Ribbon Panel to Advise on the Risk Assessment of the National Emerging Infectious Diseases Laboratories at Boston University Medical Center

What is the purpose and value of this facility?

The Boston University Medical Center (BUMC) National Emerging Infectious Diseases Laboratory (NEIDL) will provide a safe and secure facility for conducting critically important biodefense and infectious disease research.  It will offer  researchers the necessary resources to develop vaccines and other medical countermeasures for certain infectious diseases that present a public health threat.  The risk of these diseases is real, and it is vital to study the viruses and bacteria that cause these diseases and to develop ways to diagnose, prevent, and treat them.

Why did NIH support the construction of this facility in downtown Boston?

The NIH decision to provide partial funding for the construction of the NEIDL was made on the basis of scientific and technical merit, a determination resulting from a rigorous process of scientific peer review.  A major strength of the BUMC application was the proximity of the proposed facility to a large community of infectious disease researchers.  BUMC proposed the particular site within Boston for the facility.  Its decision was validated by the process required by the National Environmental Policy Act (NEPA), which mandates preparation of a report evaluating all potential environmental impacts of the project and stipulates that public input must be considered before the report is finalized.

What studies have been done to evaluate the safety and siting of this facility?

To comply with the NEPA, the NIH prepared risk analyses and solicited public comment on them.  Certain sectors of the public voiced concern about the safety and environmental impact of this facility, which in part led to lawsuits filed in Federal and State courts.  To address specific questions raised in the Federal court and to comply with the NEPA, the NIH prepared a draft supplementary risk assessments and site suitability analyses report. 

Meanwhile, a similar risk assessment process was under way at the State level, whereby BUMC was preparing analyses in compliance with the Massachusetts Environmental Policy Act.  The Massachusetts Executive Office of Energy and Environmental Affairs asked the National Research Council (NRC) to analyze the draft NIH supplementary risk assessments report because the state agency viewed it as potentially relevant to its own decision-making process. The committee assembled by the NRC issued a report in November 2007 that was critical of the NIH draft supplementary report.

Why is NIH convening a Blue Ribbon Panel to look at issues associated with this facility?

The Blue Ribbon Panel will advise the NIH on the issues and concerns voiced by the courts, the local community, the NRC Committee, and the general public regarding the BUMC NEIDL.  As part of this charge, the Panel will provide independent and scientifically based advice regarding 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, risk assessment, and risk communication.  The Panel process will be transparent and designed to address the concerns of the Boston community and the general public and to ensure that NIH has done its best to evaluate public safety concerns. 

Who is serving on the Blue Ribbon Panel?

The panel is chaired by Adel Mahmoud, M.D., Ph.D., of Princeton University, a world renowned expert in infectious diseases and international health.  The panel also includes highly respected experts in infectious diseases, public health and epidemiology, risk assessment, environmental justice, risk communications, biodefense, biosafety, and infectious disease modeling. 

How were members of the Blue Ribbon Panel selected?

Members of the Blue Ribbon Panel were selected on the basis of their standing as nationally recognized experts in the fields of infectious diseases, public health and epidemiology, risk assessment, infectious disease modeling, risk communications, biodefense, biosafety, and environmental justice.  Also taken into account was the need to ensure geographic and demographic diversity in the group.  Specifically excluded from consideration were individuals who might have a conflict of interest by virtue of having any personal interest in the NEIDL or being vested in the conclusions of any other analyses that may have been done. 

Will the meetings of the Blue Ribbon Panel be open to the public?

The Panel’s process will be transparent and its meetings will involve opportunity for public comment.  The Panel is being established as a Working Group of the standing Advisory Committee to the Director (ACD), a committee that meets in public session twice a year to advise the NIH Director on important matters affecting the NIH.  The Working Group will report periodically to the ACD at the Committee’s public meetings, and its final work product will be submitted and reviewed through the ACD as well.

What will the role of the NRC committee be in the Blue Ribbon Panel’s process?

The NRC committee has important perspectives to share with the Blue Ribbon Panel as pursues its task. The NIH asked the NRC to make recommendations regarding the characteristics of any future risk assessment studies that NIH might conduct. The NRC subsequently shared its recommendations with the Panel at its May 2, 2008 meeting. The Blue Ribbon Panel is studying these recommendations and considering them carefully.  

What is the expected outcome of this process? 

The outcome of the Blue Ribbon Panel process will be a rigorous and comprehensive evaluation that will consider the questions and concerns raised by the public, the National Research Council, and the Federal and State courts with respect to construction of the NEIDL.  Upon review of the Panel’s comments and suggestions, the NIH may do any or all of the following: conduct additional risk assessments, as warranted; revise the current draft supplementary risk assessments report, as necessary; solicit public comment on any new reports that may be generated; and submit final reports to the relevant authorities.