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Thursday, March 6, 2008
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.
NIH-funded national biocontainment laboratories, such as the one under construction at Boston University Medical Center, take stringent precautions to protect the laboratory workers' health and to reduce their individual risk, and also to safeguard the surrounding communities and the environment. "The goal is to manage and minimize risk to the lowest levels possible, recognizing that there is no 'zero risk'," Dr. Zerhouni noted.
Research in the Boston University Medical Center laboratory will focus on developing new strategies for treating and preventing a variety of bacterial and viral diseases. These laboratories are designed, constructed, and operated to be the safest, most secure labs in the world. "NIH is doing everything necessary to minimize the potential risks to the surrounding community," said Dr. Zerhouni. "We will not compromise the public's safety in our pursuit of improving the public's health," Dr. Zerhouni said.
The Blue Ribbon Panel members are as follows:
Mahmoud, Adel, Ph.D., M.D.
Department of Molecular Biology and Woodrow Wilson School
Burke, Donald, M.D.
Dean, Graduate School of Public Health
Director, Center for Vaccine Research
Associate Vice Chancellor for Global Health
UPMC-Jonas Salk Chair in Global Health
University of Pittsburgh
Eubank, Stephen, Ph.D.
Professor, Virginia Bioinformatics Institute
Deputy Director of Network Dynamics and Simulation Science Laboratory
Adjunct Professor, Department of Physics Professor
Virginia Polytechnic Institute and State University
Freimuth, Vicki, Ph.D.
Professor, Department of Speech Communication and Grady College of Journalism and Mass Communication
University of Georgia
Friedman-Jimenez, George, M.D.
Director, Bellevue Hospital Center
New York University Occupational and Environmental Medicine Clinic
New York School of Medicine
Hamburg, Peggy, M.D., M.P.H.
Nuclear Threat Initiative
Holbrook, Karen, Ph.D.
Vice President for Research and Innovation
University of South Florida
Kasper, Dennis, M.D.
William Ellery Channing Professor of Medicine
Professor of Microbiology and Molecular Genetics
Harvard Medical School
Director, Channing Laboratory
Department of Medicine
Brigham and Women's Hospital
Lewis, Johnnye, Ph.D., D.A.B.T.
Director, Community Environmental Health Program
College of Pharmacy, Health Sciences Center
Co-Director, Environmental Health Signature Program
Health Sciences Center
University of New Mexico
Lipkin, W. Ian, M.D.
Principal Investigator and Scientific Director
Northeast Biodefense Center
John Snow Professor of Epidemiology and Director
Center for Infection and Immunity
Mailman School of Public Health
Professor of Neurology and Pathology
College of Physicians and Surgeons
Murray, Tom, Ph.D.
The Hastings Center
Northridge, Mary, Ph.D., M.P.H.
Professor, Clinical Sociomedical Sciences
Mailman School of Public Health
Patterson, Jean, Ph.D.
Scientist and Chair, Department of Virology and Immunology
Southwest Foundation for Biomedical Research
Robson, Mark Gregory, Ph.D., M.P.H.
Director of the New Jersey Agricultural Experiment Station
Professor of Entomology
School of Environmental and Biological Sciences
Rutgers, The State University of New Jersey
Stanley, Samuel, M.D.
Vice Chancellor for Research
Director, Midwest Regional Center of Excellence
Biodefense and Emerging Infectious Diseases
Professor of Medicine and Molecular Microbiology
Washington University in St. Louis
Thomann, Wayne, Dr.P.H.
Director of Environmental Safety
Duke University Medical Center
The Office of the Director, the central office at NIH, is responsible for setting policy for NIH, which includes 27 Institutes and Centers. This involves planning, managing, and coordinating the programs and activities of all NIH components. The Office of the Director also includes program offices which are responsible for stimulating specific areas of research throughout NIH. Additional information is available at http://www.nih.gov/icd/od/index.htm.
About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.
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