Original article from: Newsweek posted on May 19, 2015. by Amy Maxmen Under...
Frequently Asked Questions
What is the National Emerging Infectious Diseases Laboratories (NEIDL)?
The National Emerging Infectious Diseases Laboratories (NEIDL) is part of a national network of secure facilities that study emerging and reemerging infectious diseases and develop diagnostic tests, treatments, and vaccines to promote public health.
What is the status of the NEIDL?
BSL-2 research is currently being conducted at the NEIDL and BSL-3 research began in January 2014. Having received approval from the Boston Public Health Commission to conduct BSL-3 research in the NEIDL, ongoing tuberculosis research is being transferred from another lab on Boston University’s campus.
When will higher-level research be conducted in the lab?
Higher-level research will be conducted in the NEIDL upon receipt of all necessary approvals from the Boston Public Health Commission and the Centers for Disease Control.
What was the role of the National Research Council in the Blue Ribbon Panel’s process?
The National Research Council (NRC) was asked by the NIH to provide technical input and make recommendations regarding the methodology and characteristics of the supplementary risk assessment being undertaken by the NIH.
The group reviewed the methodology used in the Draft Supplementary Risk Assessment and provided suggestions for improving the final draft.
For a copy of the NRC report, please visit http://dels.nas.edu/Report/Continuing-Assistance-National-Institutes/13310.
The Final Supplementary Risk Assessment and the Reader’s Guide were published on July 6, 2012.
What type of activity or work is currently taking place at the NEIDL?
Training exercises have taken place with BUMC researchers, technicians, laboratory and public safety personnel, and city, state, and federal safety and regulatory agencies. The training exercises provide the opportunity to develop, test, and practice safety and emergency response procedures.
BSL-2 research began in early April 2012. BSL-3 research began in January 2014.
What is a Biosafety Level 4 (BSL-4) laboratory?
The Centers for Disease Control specifies four levels of increasing containment for research on infectious diseases. These are generally termed Biosafety Levels 1 through 4 (BSL-1 to BSL-4). While much of the infectious diseases research is done in laboratories with BSL-2 and BSL-3 capabilities, BSL-4 laboratories are needed for research on infectious diseases that are usually life threatening.
BSL-4 lab practices, safety equipment, and facility design and construction are appropriate for work with agents that pose a high individual risk of life-threatening disease and for which there is no available vaccine or therapy. Researchers in a BSL-4 lab wear a full-body, air-supplied positive-pressure personnel suit. There are also special engineering and design features to prevent microorganisms from being disseminated into the environment.
Researchers who use a BSL-4 laboratory have extensive training in handling hazardous infectious agents. Access to BSL-4 laboratories is strictly controlled. For more information on biosafety levels, please download a copy of ‘Biosafety in Microbiological and Biomedical Laboratories’ here: http://www.cdc.gov/biosafety/publications/bmbl5/index.htm.
Will bioweapons be developed at the NEIDL?
Bioweapons research is illegal. Boston University has publicly pledged that research on bioweapons will not take place at the NEIDL. There will be no classified research conducted at the NEIDL.
How can you ensure nothing leaks from the NEIDL?
The BSL-4 facility is one of the most carefully designed and constructed types of buildings of its kind in the world. The BSL-4 laboratory at the NEIDL will operate as a self-contained unit with its own filtration, decontamination, and waste disposal systems. In addition, all critical systems at the NEIDL are built with redundancies so that back-up units can be used in the event that primary units fail. As an example, the air that comes out of the NEIDL is double filtered through high efficiency particle filters and the air from the entire building will undergo additional high-level filtration. In effect, the air that leaves the NEIDL is cleaner than the air that comes in.
How will BSL-4 agents be transported to the NEIDL?
Transportation of infectious materials is governed by strict national and international rules including guidelines from the Department of Transportation and the International Air Transport Authority (IATA). All biological samples that are potentially infectious are packed, shipped, and transported by authorized individuals. BUMC is notified in advance that a shipment is expected and when it has arrived. Trained personnel are given the schedule of arrival for incoming shipments and are prepared to receive them. View the transportation policies contained in Biosafety in Microbiological and Biomedical Laboratories, Centers for Disease Control, 5th Edition, 2007.
Are there other BSL-4 laboratories around the country?
BSL-4 laboratories are sited at the following locations throughout North America:
- Canadian Science Centre for Human and Animal Health, Winnipeg, Canada
- Centers for Disease Control and Prevention, Atlanta, Georgia
- Galveston National Laboratory, Galveston, Texas
- Georgia State University, Atlanta, Georgia
- Rocky Mountain Laboratories (NIAID), Hamilton, Montana
- Texas Biomedical Research Institute, San Antonio, Texas
- USAMRIID, Ft. Detrick, Frederick, Maryland
- National Institutes of Health (NIH), Bethesda, Maryland
- Shope Laboratory, Galveston, Texas
- Division of Consolidated Laboratory Services, Richmond, Virginia
- National Bio and Agro-Defense Facility (NBAF), Manhattan, Kansas [Fully Operational in 2015]
What is the safety record of BSL-4 laboratories?
In more than 100 combined years of operation, there has never been a community incident or environmental release at a BSL-4 laboratory in North America. BSL-4 laboratories have an excellent safety record.
Where is the NEIDL located?
The NEIDL is located on the Boston University Medical Campus along Albany Street in Boston’s South End. Its siting is designed to support innovation in biomedical research and science and promote novel partnerships between academia and industry.
Why is the NEIDL located in a densely populated area like the South End?
The location of the NEIDL provides an appropriate setting where established teams of researchers can work together and collaborate on medical research with important infrastructure in place to operate. In addition, the South End location provides the ability to integrate the important infectious diseases research with extensive medical, clinical, and research facilities, including other medical research facilities throughout the City of Boston.
What kind of background checks are required to work at the NEIDL?
Approval and clearance for staff to work at the NEIDL is determined by Boston University Medical Campus, consistent with institutional and government-mandated regulations and standards.
All employees working in the NEIDL undergo a comprehensive background check, which may include review of criminal background, financial history, and psychological testing.
What systems are in place to guard against malicious use of pathogens by scientists working inside the NEIDL?
Scientists and researchers hired to work at the NEIDL undergo a rigorous background check that includes, among other things, psychological testing and a review of their financial history. In addition, state-of-the-art surveillance and audit systems built into the design of the NEIDL, such as use of the two-person rule in the BSL-4 lab and iris scans to access certain areas, help ensure proper oversight and monitoring of pathogens.
Who provides oversight of the National Emerging Infectious Diseases Laboratories?
The NEIDL is owned, operated, and managed by Boston University. Various local, state, and federal agencies oversee various elements of the operations and research at the NEIDL including the National Institutes of Health, the Center for Disease Control, and the Boston Public Health Commission. View a chart of federal and state agencies.
How will BUMC ensure first responders have the expertise and training necessary to respond to an incident at the NEIDL?
Over the past few years, nearly 400 first responders, including representatives from Boston’s Emergency Medical Service, Fire and Police, Inspectional Services Department, Public Health Commission, Homeland Security, Transportation Department, and the Massachusetts Department of Public Health participated in a series of orientation sessions and other training sessions to prepare for responding to incidents at the NEIDL. During the sessions, no research was conducted and live research agents were not used at the NEIDL.
In addition, training exercises with BUMC researchers, technicians, laboratory and public safety personnel, and city, state, and federal safety and regulatory agencies are ongoing. These training exercises provide the opportunity for scientists and city, state, and federal agencies to develop, test, and practice safety and emergency response procedures.
How can the community monitor what is studied at the NEIDL?
Community participation is important to success at the NEIDL. The governance structure for the NEIDL consists of several committees including a Community Liaison Committee (CLC) to promote public participation and transparency during construction and operation of the lab. CLC members meet regularly and provide outreach and feedback to facilitate information flow between the NEIDL and the community. The CLC minutes are posted on the NEIDL website: http://www.bu.edu/neidl/community/clc/meeting-minutes/.
The Institutional Biosafety Committee (IBC) reviews and approves all research projects at Boston University and ensures the safe conduct of research. The community can review the proceedings of the IBC through the monthly meeting minutes posted on the web at http://www.bu.edu/orccommittees/ibc/committee/ibc-minutes/.
In addition, all research on the Medical Campus, including the NEIDL, requires approval from appropriate University committees and external regulatory agencies. These include: the Institutional Biosafety Committee, the Institutional Review Board, the External Scientific Advisory Committee, where appropriate, the Institutional Animal Care and Use Committee, the Boston Public Health Commission, and the Centers for Disease Control. Many of these committees and agencies include and/or require community representation in their membership.
How will the community be notified in the event of an emergency or evacuation at the NEIDL?
All public health emergencies or evacuation incidents impacting residents involve notification of the appropriate local public safety officials and emergency responders who are then responsible for notifications to residents concerning protective actions and evacuations. Boston University Medical Center works closely with local and state law enforcement, public health agencies, and first responders and has developed a response protocol for the NEIDL that identifies a NEIDL Emergency Response Team that works with the City of Boston in the case of emergencies or evacuation procedures.
What is the community benefit from the NEIDL?
Research at the NEIDL is important to public health locally, nationally, and throughout the world. This research will benefit the community through development of new treatments, diagnostics, and preventive vaccines against emerging and re-emerging infectious diseases. The NEIDL had a significant economic and community impact during the construction phase. More than 1,300 construction jobs were created. An anticipated 660 permanent jobs—at all levels including environmental services, lab technicians, scientists, and administrative staff—will be created as part of the facility’s operation.
The NEIDL contributed $1.9 million in job training and housing linkage payments to the City of Boston. In addition, BUMC and Boston University will make annual PILOT payments (Payments in Lieu of Taxes) to the City of Boston. In FY2013 alone, Boston University contributed more than $5.3 million in PILOT payments, and nearly $5 million in net real estate tax.
How can I learn more about available employment and training opportunities?
Employment opportunities at the NEIDL are being created at all levels, including positions for scientists, researchers, lab technicians, and administrative and support services. If you are interested in employment opportunities at the NEIDL, please send a letter of interest and curricula vitae or resume to firstname.lastname@example.org.
Employment and training opportunities are also available on the Medical and Charles River Campuses of Boston University.
What is the status of the federal and state lawsuits?
The NIH published the Final Supplementary Risk Assessment in July 2012. The Supplemental Record of Decision for the Final Supplementary Risk Assessment was published in January 2013.
On September 30, 2013, the Federal court ruled that the Final Supplementary Risk Assessment prepared by the National Institutes of Health adequately analyzed the risks associated with research involving pathogens at BSL-3 and BSL-4 at the NEIDL and that such research could be done safely at the BU Medical Campus site.
On June 11, 2014, the State Court ruled that the Secretary of Energy and Environmental Affairs properly determined that the Supplemental Final Environmental Impact Report complied with the Massachusetts Environmental Policy Act (MEPA) and dismissed the Plaintiffs complaint.