UTHSC Regional Biocontainment Lab (RBL) Frequently Asked Questions
1. Why is a biosafety laboratory necessary?
2. What's in it for the local community?
3. How many people will work in the facility?
4. What diseases will be studied?
5. How dangerous are these diseases?
6. Will this facility pose any threat to the local community?
7. Has there ever been an incident in similar facilities that exposed the community to the infectious agents?
8. Has there ever been an incident at a similar facility that caused release of micro-organisms into the environment?
9. Have there ever been incidents in similar facilities that exposed workers to the infectious agents?
10. What precautions are in place for transporting infectious materials to and from the lab?
11. Can the UTHSC RBL be converted to a BSL-4 level facility?
12. Would this facility make Memphis or the UTHSC RBL a target for terrorism?
13. What regulatory and certification processes are in place?
14. What internal oversight systems will be in place?
15. Why can't the research be carried out in existing research facilities already operating at UTHSC?
16. How can the public be sure that the UTHSC RBL won't be making biological weapons?
17. Will the research be secret?
18. What are biosafety levels?
Q1: Why is a Biosafety Level 3 laboratory necessary?
A: First, this BSL-3 laboratory will allow our scientists to build upon the work they have been doing in the safest possible environment while expanding the available space to do so. The increase in numbers of key infectious diseases, the emergence of new infectious disease agents, and the threat of new bioterrorism events make our study of these diseases more important than ever before. The new lab will allow us to accelerate the search for effective vaccines and treatments for these diseases.
Second, our researchers have a responsibility to contribute to the advancement of public health in our community, our nation and the world. Because of the kind of research they will be able to do in this new state-of-the-art biosafety laboratory; they will be able to make a greater contribution to protect the public against emerging infectious diseases.
Q2: What's in it for the local community?
A: The work done in this facility will help attract additional top researchers and research grants to University of Tennessee Health Science Center (UTHSC) and new business to the UT Baptist Research Park. One of the objectives of this facility and related research is the development of new diagnostic tools, drugs and vaccines for important infectious disease agents. These new products hold great promise for technology transfer, which could lead to new, locally based technology companies being established to develop and market these products, leading to more jobs for community members. In addition, these new products, when brought to market, have significant potential to improve the health and well-being of citizens.
Q3: How many people will work in the facility?
A: An estimated 80 personnel will have access to the RBL. This will include: The lab director and facility manager, the biosafety officer, principal investigators and their research personnel, veterinarians, animal care personnel, research technicians, safety personnel, facilities personnel (engineers), occupational health personnel, UTHSC police officers, IT personnel.
Q4: What diseases will be studied?
A: At the UTHSC RBL, we will initially be studying tuberculosis and tularemia. Tuberculosis is caused by an organism called Mycobacterium tuberculosis and tularemia is caused by Francisella tularensis. Other organisms may be added as research expands and new faculty is recruited to UTHSC.
Q5: How dangerous are these diseases?
A: All of the diseases studied in the RBL will be diseases that are currently found naturally in the environment or in human and animal populations. All will be classified as Biosafety Level-3 organisms. According to the Centers for Disease Control (CDC):
Biosafety Level 3 is applicable to clinical, diagnostic, teaching, research, or production facilities where work is performed with indigenous or exotic agents that may cause serious or potentially lethal disease through inhalation route exposure.
M. tuberculosis is the bacteria that causes tuberculosis, a leading cause of morbidity and mortality worldwide. Persons infected with M. tuberculosis can develop active disease within months of infection or can remain latently infected and potentially develop disease later in life. The primary focus of infection is the lungs, but most other organs can be involved. HIV infection is a serious risk factor for development of active disease. Tuberculosis is spread by infectious aerosols produced by coughing.
Francisella tularensis is carried in numerous animal species, especially rabbits, and is the bacteria that causes tularemia (Rabbit fever, Deer fly fever, Ohara disease, or Francis disease) in humans. Person-to-person transmission of tularemia has not been documented. Tick bites, handling or ingesting infectious animal tissues or fluids, ingestion of contaminated water or food and inhalation of infective aerosols are the primary transmission modes in nature. Occasionally infections have occurred from bites or scratches by carnivores with contaminated mouth parts or claws.
Q6: Will this facility pose any threat to the local community?
A: A properly constructed and properly operated BSL-3 facility poses no threat to the local community. There are no recorded incidents in the United States involving community exposure or illness resulting from research activities carried out in any of the existing BSL-3 facilities.
Q7: Has there ever been an incident in similar facilities that exposed the community
to the infectious agents?
A. No. Hundreds of BSL-3 facilities currently operate safely in the United States. BSL-3 laboratories have been in operation for over 30 years. Rarely accidents, such as needlesticks, may cause exposure of laboratory staff to infectious agents. However, protocols for immediate treatment of any person exposed while working in the laboratory avoid any danger of spread to other workers or to the community.
Q8: Has there ever been an incident at a similar facility that caused release of micro-organisms
into the environment?
A. Not in the United States. The design of a BSL-3 laboratory is intended to not only protect the workers in the facility, but also to prevent any accidental release of infectious agents from the laboratory environment to the external community. See Biosafety and Security section for more detail.
Q9: Have there ever been incidents in similar facilities that exposed workers to the
A: There have been a small number of reported incidents in the United States in which laboratory workers have been exposed to potentially dangerous infectious agents while working in BSL-3 laboratories. In no case has an infectious agent handled in a BSL-3 laboratory in the United States exposed a member of the community to an illness or resulted in illness within the community. Exposure of laboratory personnel to infectious agents is generally the result of equipment failure or an accident in the laboratory (such as a needle stick or leaking vial). While there are several levels of procedures that strive to prevent such failures or accidents, they cannot be prevented 100% of the time. That is the purpose of working with these materials in a BSL3 laboratory. If primary procedures for containment fail, then the facility itself acts as a secondary containment barrier, so that infectious agents are not released into the environment. All personnel wear Personal Protective Equipment, which in the event of an accident gives the worker time to exit the facility safely. Personnel are then treated by medical personnel according to established protocols and the incident is documented. If required, a report is sent to the appropriate federal agencies.
Q10: What precautions are in place for transporting infectious materials to and from
A: There are specific and strict government regulations for transportation of infectious materials. Infectious materials are safely transported worldwide on a daily basis under these regulations (See http://bmbl.od.nih.gov/appendc.htm). UTHSC follows all international, federal, state and local regulations for the transport of infectious materials and all personnel responsible for the shipping and handling of infectious materials must be trained and certified to ship these materials. The UTHSC Safety Department provides training for the Shipping of Hazardous Materials / Dangerous Goods in accordance with the Department of Transportation (DOT) regulations (49 Code of Federal Regulation) and the International Air Transportation Association (IATA) Dangerous Goods Regulations. Each session contains the required elements of General Awareness, Security and Safety; and function-specific training determined by the materials to be shipped by the trainee. All trainees are required to pass a written exam at the end of the training session.
Q11: Can the UTHSC RBL be converted to a BSL-4 level facility?
A: No. BSL-4 laboratories require a very different structural design than BSL-3 laboratories. Therefore, it is not possible to convert a BSL-3 into a BSL-4 laboratory. For this reason, BSL-4 organisms can not and will not be studied in this facility
Q12: Would this facility make Memphis or the UTHSC RBL a target for terrorism?
A: The RBL has been designed according to a detailed Threat and Risk assessment to incorporate design features that protect the RBL from potential attacks, unauthorized access and overall make it a more difficult target. Typically, terrorists have chosen "soft" targets such as night clubs, office buildings, hotels and public transit rather than guarded, restricted access facilities. It is also important to note that researchers work with small quantities of infectious agents in forms that are not easily dispersed and therefore not suitable for bioterrorism purposes. Therefore, bioterrorists seeking dangerous microorganisms are more likely to find a more easily acquired source elsewhere.
Q13: What regulatory and certification processes are in place?
A: The National Institutes of Health requires stringent review of the design, construction, commissioning and certification of the RBL. An independent team of engineers, architects, security, and biosafety professionals was selected by NIH. This team has performed a detailed analysis of the design of the RBL at the 15, 35, 75, 95 and 100% design level before construction was started. Members of this team visit Memphis monthly to participate in meetings with UTHSC personnel and construction contractors, and perform site inspections for quality assurance. Members of this team will also review operational standard operating procedures for the RBL.
During the design phase, Tetratech Inc. performed a Threat and Risk assessment to ensure the design incorporated features to protect the RBL from being compromised by both deliberate means or from natural disaster. They also performed an Environmental Assessment to evaluate potential impacts of the facility on the area including: air quality, human health, environmental justice, waste management, traffic and transportation.
International Commissioning Engineers (ICE) was hired to review the design of the RBL, inspect the construction of the RBL on a monthly basis and perform a final inspection and test of all the systems in the RBL to ensure they have been installed properly and function together properly as a system.
An independent Certification company that specializes in certification of BSL3 facilities will perform a final inspection of the RBL and certify it is properly constructed and ready for operation.
Finally, the Centers for Disease Control (CDC) will inspect the RBL facility itself as well as our Facility Security Plan, Biosecurity Plan, Standard Operating Procedures, Emergency and Incident Response Plan, Cybersecurity Plan, Occupational Health Plan, BSL3 Training Program and our record keeping system to ensure all meet Federal Requirements and Standards according to The U.S. Departments of Health and Human Services (HHS) and Agriculture (USDA) published final rules for the possession, use, and transfer of select agents and toxins (42 C.F.R. Part 73, 7 C.F.R. Part 331, and 9 C.F.R. Part 121).
Q14: What internal oversight systems will be in place?
A. To ensure all research conducted in the RBL occurs safely and in accordance with federal regulations, all procedures and research plans will be reviewed by the Institutional Biosafety Committee (IBC) and the Biosafety Level 3 committee before work is initiated. When required, research proposals and standard operating procedures will be reviewed by the Animal Care and Use Committee and the Institutional Review Board. Inspections are performed regularly to ensure work is being performed according to approved procedures and records are properly kept. Additionally, members from these committees review documentation annually to ensure all laboratory procedures, biosecurity plans, emergency response plans and records are up to date and accurate.
Q15: Why can't the research be carried out in existing research facilities already
operating at UTHSC?
A: The use of BSL-3 is required for research on certain agents and for certain experiments, such as the testing of vaccines or antibiotics against infectious microbial agents that are classified at BSL-3. Many of the programs at UTHSC are currently developing therapies for diseases using related organisms that are less pathogenic than the human pathogen. In order to further their work so that these therapies may progress into actual clinical trials, the researchers must test their therapies on the organism that actually causes the disease in humans. The current BSL-3 facility at UTHSC is not large enough to support these activities. The RBL significantly expands the capability of the UTHSC researchers to conduct research on these highly infectious agents which will allow researchers to produce a higher quality of research and result in development of new technologies for detection of infectious agents, new therapeutics for use in prophylaxis and treatment of infectious agents, and ultimately in the development of vaccines to protect the public against emerging infectious agents.
Q16: How can the public be sure that the UTHSC RBL won't be making biological weapons?
A. The UTHSC RBL will not make any biological weapons or stockpile any infectious disease agents in large quantities. Indeed, under the terms of the Biological Weapons Convention signed by the United States in 1975, the signatory parties agreed not to develop, produce, stockpile or acquire biological agents or toxins "of types and in quantities that have no justification for prophylactic, protective and other peaceful purposes," as well as weapons and means of delivery.
Q17: Will the research be secret?
A: The ultimate goal of this research program is to make new discoveries and to translate these discoveries into new diagnostics, treatments and vaccines that will combat agents of bioterrorism and emerging infectious diseases. Although safety and security concerns will restrict access to the facility, it is anticipated that all research carried out in the facility will be published and communicated in the same manner as other research conducted using federal (i.e. NIH) funding.
Mark A. Miller, Ph.D.
Interim Director, UTHSC Regional Biocontainment Laboratory
Departments of Microbiology, Immunology & Biochemistry
And Medical Education