|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,
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
"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
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.
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.
The National Institutes of Health (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. It is the primary federal agency for conducting
and supporting basic, clinical and translational medical research,
and it investigates the causes, treatments, and cures for both
common and rare diseases. For more information about NIH and
its programs, visit www.nih.gov.