What is a biocontainment laboratory?
Biocontainment laboratories are specially designed facilities to provide safe settings for work with the most serious infectious microorganisms (e.g., bacteria and viruses). Rigorous safety practices, state-of-the-art safety equipment, and specially engineered building features ensure that laboratory personnel and the surrounding community are not exposed to the microorganisms. Depending on what will be handled in the facility, the Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH) require laboratories to meet safety levels in one of four safety levels. Level 4 is the highest, used to contain potentially threatening microorganisms.
How many Biosafety Level 4 laboratories exist in North America?
At present, there are six high-containment infectious disease laboratories in the U.S. and Canada: the Centers for Disease Control, Atlanta, Ga.; the U.S. Army Medical Research Institute of Infectious Diseases, Fort Detrick, Frederick, Md.; the Viral Immunology Center at Georgia State University, Atlanta, Ga.; the NIH, Bethesda, Md.; the Southwest Foundation for Biomedical Research, San Antonio, Texas; and the Canadian Science Center for Human and Animal Health in Winnipeg, Manitoba.
In addition, three new laboratories are under design or construction: the Center for Biodefense at the University of Texas Medical Branch in Galveston, Texas, the NIH Rocky Mountain Laboratory BSL4 in Hamilton, Montana, and the National Emerging Infectious Diseases Laboratory at Boston University Medical Center in Boston, Massachusetts.
Why does the U.S. need more laboratories with Biosafety Level 4 capabilities?
Crucial gaps exist in the country's ability to handle a biological threat and to study naturally occurring viruses and bacteria such as AIDS, hepatitis C, tuberculosis and West Nile virus. Among them is the lack of vaccines and cures for diseases that might result from the spread of certain microbes which can be studied safely only in Biosafety Level 4 laboratories. The National Institute of Allergy and Infectious Diseases (NIAID) believes that the U.S. needs more of these high-containment laboratories so researchers can develop appropriate therapeutic agents in a timely fashion. The facilities would also be used in times of national emergency to provide state-of-the-art laboratory capabilities and research expertise for major metropolitan areas. The agency wants to build new Biosafety Level 4 laboratories (National Biocontainment Laboratories) and Biosafety Level 3 laboratories (Regional Biocontainment Laboratories) in different regions in the country.
In addition, these laboratories are an important component of the federal government’s efforts to expand research and share information more efficiently.
What kind of research will be conducted at the center?
BUMC and collaborating scientists from other institutions will be studying a variety of bacteria and viruses. The goal of these studies is to develop drugs and vaccines to combat these microorganisms so that they no longer pose a threat to anyone.
For the most part, the research will involve only non-infectious "pieces" of these microbes-e.g. the proteins that sit on the surface of their cells, which can be used to generate antibodies-or microbes that have been disabled so they cannot reproduce. Some of this research would require nothing more than routine controls to prevent infection, such as hand washing (Biosafety Level 1). Other work would require precautions similar to those that are standard practice in hospital surgical suites, including containing microorganisms in specialized chambers and sterilizing all materials after testing (Biosafety Level 3). Several Biosafety Level 3 laboratories already exist in universities in the Boston area, including three at BUMC.
Biosafety Level 4, the highest level of containment, will be necessary only when scientists are working with the fully functioning microorganisms. Except in times of a government-designated national emergency, the vast majority of the research would not involve such microorganisms, and only the smallest quantities necessary would be used. Stringent safeguards, mandated by the NIH and CDC, will be in place.
What safety precautions are required in a laboratory with a Biosafety Level 4 component?
The National Institutes of Health, Division of Safety oversees the design and building of Level 4 biocontainment facilities. They review all plans for the facility as well as oversee all experiments using a very stringent approval process.
Level 4 biocontainment facilities are built with multiple and redundant containment and safety measures to ensure the highest levels of protection. The BUMC biodefense lab will be built in an enclosed area and have special features to ensure that all infectious materials are contained and completely destroyed after testing. Some of the safeguards that this facility will have include microfiltration of air, air-lock buffer zones, sterilization of all infectious materials and high-level security restricting access to laboratory and storage areas.
A complete list of the safety requirements for Biosafety Level 4 laboratories is available from the NIH.
Why should a Level 4 laboratory be built at BUMC? Why not somewhere else?
BUMC is an academic medical center with renowned scientists on its staff and is one of the leading research facilities in the country. The Level 4 laboratory will be at the forefront of the nation’s efforts to research emerging trends and as such, will place our region in a unique place to respond to infectious diseases incidents in the most timely manner.
The BioSquare research buildings on the campus were built in the last decade. They provided the medical center with the expertise needed to construct research laboratories. In addition, Boston Medical Center is home to the region's busiest Level One trauma center located at Boston Medical Center. Relationships with EMS, and other emergency responders already exist and these relationships will be leveraged to enhance the research in a new facility.
Why not put the facility outside the metropolitan area, in a remote location?
Rapid response can mean the difference between life and death. The faster a biological sample can be analyzed, the faster it can be assessed and addressed. Currently, there are no laboratories with Biosafety Level 4 components – needed to analyze these biological samples -- serving the northeastern United States. BUMC’s facilities would have a lab capable of safely analyzing such biological materials and would also have ready access to facilities at Boston Medical Center where sophisticated response units have been developed to treat infected patients. All components of the medical response infrastructure would be together and could function as a tightly-knit unit - a high priority when rapid response is required.
BSL4 labs need to be where the scientists are and where the people they serve live. Having the lab within the BUMC and with easy access to transportation ensures that scientists in the New England Area can devote the maximum amount of time to their laboratory investigations. The laboratory will be an indispensable resource to the many top scientists in the New England area and elsewhere on the East Coast of the US.
How would BUMC’s program benefit the local community?
Training is a major component of the infectious diseases research program, with the goal of developing an expanded cadre of new researchers, clinicians, and technical personnel who can help lead the research mission into the future. These professionals would be an invaluable and much-needed resource in the city, state and region. Highly trained personnel and sophisticated research facilities would be available to collaborate with and support the activities of the Massachusetts Department of Public Health and other regional and public health and healthcare agencies.
Won't placing a Biosafety Level 4 lab in the heart of Boston make us a greater terrorist target than we already are?
Biosafety Level 4 laboratories are among the most secure facilities in the world. There has never been a security breach at a Level 4 lab and the security protocols that would be in place at the facility will, at minimum, meet the government-enforced security standards at other Level 4 labs. Multi-level security devices will be installed throughout the facility, including observation cameras and card reader systems. Also, the presence of a biocontainment laboratory would make the city a less desirable target because of the rapid, comprehensive response to an incident that could be provided by the lab, its personnel, medical institutions and public health authorities.
Have there been any incidents in which microbes were released into the environment from a Biosafety Level 4 laboratory?
No. Biosafety Level 4 laboratories are considered to be extremely safe-so safe, in fact, that a daycare center is located next door to the laboratory at the CDC in Atlanta. These laboratories have operated safely in the United States for 30 years, with no reported incidents affecting communities near any of the existing facilities. One such lab was described as a "submarine operating within a bank vault."
How are infectious materials brought to Level 4 laboratories?
The shipment of infectious materials is governed by strict national and international rules. Infectious samples delivered to and from the facility are hermetically sealed. Samples are shipped in small sealed capsules packed singly in unbreakable (either plastic or metal) watertight containers, which are then placed in a Styrofoam box (usually containing dry ice) fit within a larger shipping box. The NIH requires specific transportation instructions for both the sender and the receiver. All shipping requires advanced approval by the CDC and careful tracking and monitoring by the institutions involved. Rules governing the transport of materials are available from the NIH
Will BUMC’s National Center for Emerging Infectious Diseases and Biodefense develop biological weapons?
Absolutely not. The center's goal is to develop defenses and therapeutics-e.g., vaccines and new drugs-to protect military personnel and civilians against a biological attack. The new laboratories will be funded and directed by the National Institutes of Health, whose mission is to acquire new knowledge to help prevent, detect, diagnose, and treat disease and disability.
Who would have access to the facility?
Access to such a facility would be strictly controlled. Only essential, highly trained, pre-screened research personnel from BUMC and other institutions would be able to get into the laboratory. All persons entering the lab would have security clearances. The lab would operate under tight government supervision.
Who will pay for the laboratory?
The federal government will pay 75 percent of the cost and the sponsoring institutions (Boston University and Boston Medical Center) will pay the remaining 25 percent from funds set aside for facility development. Operating funds will come from government grants for research and operating costs.
Who will represent the neighborhoods concerns while the center is being built?
BUMC has been reaching out to community leaders, business leaders and others local residents through more than 200 public meetings to open communications about the project and address any concerns. In addition, a community liaison group was formed to provide an ongoing avenue for the community to identify concerns and for the project team to communicate with the community.
Where can I get additional information on some of these issues?
The following websites are excellent resources:
CDC Bioterrorism Preparedness and Response
US Army Medical Research Institute of Infectious Diseases www.usamriid.army.mil.education/bluebook.html
List of pathogens and data sheets www.bt.cdc.gov.Agent/Agentlist.asp
Emerging Infectious Diseases (journal): Special Issue on Bioterrorism www.cdc.gov/nciod.eid.vol5no4/content.htm
Boston Public Health Commission www.bphc.org/bphc/prepare.asp
Massachusetts Department of Public Health www.state.ma.us/dph/topics/bioterrorism/bt.htm