NIH Outlines Next Steps to Address Safety Concerns about Boston-area Laboratory

The National Institutes of Health (NIH) today announced additional steps in a comprehensive plan to address public safety concerns regarding a national biocontainment research laboratory now under construction at Boston University Medical Center. Research in the laboratory, the construction of which is funded partly by the NIH, will focus on the development of diagnostics, treatments, and vaccines for a variety of infectious diseases.

"Our number one concern is the safety of the people working in the laboratory and those living in the surrounding communities," Elias A. Zerhouni, M.D., NIH director, said. "All of the analyses conducted to date indicate that the risks posed by this lab are extremely low. We recognize that the community has remaining concerns, however, and we will address those concerns rigorously, objectively, and comprehensively."

NIH has established an internal Coordinating Committee to guide the agency's efforts to address safety concerns raised by community representatives and other members of the public, as well as a recent review by the National Research Council of the NIH draft supplementary risk assessments for the Boston laboratory.

NIH also has established a Blue Ribbon Panel, chaired by Adel Mahmoud, M.D., Ph.D., of Princeton University, that will review current risk assessments and provide independent technical expertise and guidance. The panel includes experts in infectious diseases, public health and epidemiology, risk assessment, environmental justice, risk communications, biodefense, biosafety, and infectious disease modeling. Panel members, listed below, will provide ongoing, expert input and may recommend scenarios to study in any necessary additional risk assessment analyses.

The first public meeting of the Blue Ribbon Panel will take place at NIH on March 13, 2008. The panel will be convened as a Working Group of the Advisory Committee to the NIH Director, a standing high-level scientific advisory body providing advice directly to the NIH leadership. The panel will advise the NIH in determining the scope of any additional environmental risk assessment that the agency will conduct. The panel will then provide independent scientific advice regarding the oversight and conduct of the ensuing study and its conclusions. The Blue Ribbon Panel's process of deliberation and consultation will include soliciting the perspectives and input of the National Research Council on the risk assessment studies. Any additional studies would be performed consistent with the National Environmental Policy Act (NEPA), which directs agencies to consider the potential environmental impacts of their actions.

"The biomedical research conducted in facilities such as the one under construction at Boston University Medical Center is essential for developing vaccines, therapies, and diagnostics to protect the American public against infectious diseases that may occur naturally or be deliberately introduced," said Anthony S. Fauci, M.D., Director of the National Institute of Allergy and Infectious Diseases (NIAID). NIAID, an NIH component, is providing partial construction funds for the Boston laboratory.

"Through a transparent process, we will thoroughly examine any potential risks to the community associated with this project and continue to promote open communication and mutual understanding," he added.

In accord with NEPA, NIH completed a Final Environmental Impact Statement and issued a Record of Decision in February 2006 that affirmed the safety of the laboratory. Supplementary risk assessments were drafted in response to concerns raised in a federal court proceeding regarding a challenge to NIH's previous review.

For more information, visit
http://www.nih.gov/news/health/mar2008/od-06.htm