Questions & Answers
- What kind of lab is the university building?
- Why is the lab called a “biosafety” lab?
- Are there any other Level 3 biosafety labs in Kentucky?
- Why does U of L want to build this lab?
- What type of work will researchers be doing at the U of L lab?
- How will the lab benefit the Louisville community?
- Have any studies been done to see if building these biosafety labs actually will boost economic development?
- Will the lab serve only the Louisville area?
- How significant is it that U of L was selected to build the lab?
- What are the physical requirements for a lab built through the NIH program?
- How many researchers will work in the lab?
- Where will the lab be located?
- Why Shelby Campus and not some other location?
- Does U of L have the expertise to design and build this lab?
- Who is paying to build the lab and how much is it going to cost?
- How will U of L come up with its share of the cost?
- What kind of biological agents will researchers be working with in UofL’s lab?
- What's the difference between Biosafety Level 3 and Biosafety Level 4?
- Does U of L plan to eventually convert its proposed Level 3 lab to a Level 4?
- Will research at the lab involve the use of laboratory animals?
- How are you going to make sure that the lab does not pose a health risk to researchers, people on the campus and members of the community?
- What research safeguards are already in place?
- Will having the lab be an asset in training emergency personnel?
- Will there be tight security for the lab?
- Could there be an accident in the lab?
- What is UofL doing to ensure that no biological agents escape from the lab?
- Are there any studies that show a biological agent could spread through the air and harm people in the surrounding area?
- What if a delivery person dropped a package containing one of the agents outside on the loading dock at the facility?
- What if a mouse infected with tularemia or antibiotic-resistant TB went missing or got out of the lab?
- What if a vehicle leaving the lab became contaminated with an agent and carried the agent outside onto the grounds or off the property?
- What if an agent leaked into the ground through waste or drain water from the lab?
- What if a lab worker were accidentally exposed to an agent and became infected?
- Will the lab make Louisville a target for terrorism?
- Will the lab pose any environmental risk to Beargrass Creek?
- Will the lab have any other impact on the environment?
- How will biological materials be transported to and from the lab?
- You say the chance of an accident in the lab is highly unlikely, but if a worst-case scenario did occur how would you warn people?
- What is the timeline on the project?
- What has the university done to let people know about the lab?
- Will you continue keeping the community informed of this project?
- Where can we get more information?
1. What kind of lab is the university building?
UofL is creating a state-of-the-art laboratory where researchers will work to develop “smart” vaccines to try to stay one step ahead of infectious diseases. Researchers at the Center for Predictive Medicine will focus on a new area of study geared toward protecting people from difficult-to-control diseases such as influenza and antibiotic-resistant tuberculosis.
2. Why is the lab called a “biosafety” lab?
This laboratory is one of several Level 3 Regional Biosafety Labs being created across the country through a National Institute of Allergy and Infectious Diseases plan to better protect Americans from biological threats. This plan calls for more research aimed at diagnosing illnesses caused by biological agents and developing treatments, vaccines and cures. It does not call for developing biological weapons, which is not permitted under international law.
Regional biosafety labs are now being built at 13 universities. University of Hawaii will be the westernmost regional lab. Others will be built at the University of Chicago, University of Missouri at Columbia, Duke University, Tulane University, University of Alabama at Birmingham, University of Pittsburgh, University of Tennessee at Memphis, University of Medicine and Dentistry of New Jersey at Newark, Colorado State University, Tufts University and George Mason University.
3. Are there any other Level 3 biosafety labs in Kentucky?
Yes, there are two. A small one already exists on UofL's Health Sciences Center campus and there is another at the University of Kentucky. Both labs are approved and certified by all required federal agencies for biosafety and security. UK is in the early stages of developing additional Level 3 facilities needed for continuing growth of its research in microbiology and infectious diseases.
4. Why does UofL want to build this lab?
The university believes that research on infectious diseases is critical to the health and security of our city, state, nation and world. The threats posed by infectious agents today are serious whether they stem from terrorism or natural causes. For example, the rapid spread of West Nile virus across the United States and the spread of SARS in China, Vietnam, Taiwan and even Canada are examples of how vulnerable we are to new diseases and pathogens. There is an urgent need to understand the behavior of these infectious agents and to learn how we can better prevent, control and treat them.
5. What type of work will researchers be doing at the UofL lab?
UofL scientists will work to determine which genes and proteins keep infectious diseases out of our bodies and which genes and proteins let them in. The lab’s top-of-the-line facilities, as well as new technologies that can be made available there such as genetic mapping, proteomic profiling and computer-based data mining, will help researchers ramp up their efforts to find ways of fighting infectious diseases.
6. How will the lab benefit the Louisville community?
Not only is UofL a major participant in the local economy and one of its largest employers, but studies have shown that every dollar spent on research at UofL is returned many times to the economy in the form of new jobs and new revenue. Creation of a lab of this level will allow UofL to qualify for additional federal research funding. The lab also will provide training that students will be able to use in the workforce. In addition, any new products developed at the lab, such as diagnostic tools, drugs or vaccines, could lead to the creation of new, locally based technology companies.
7. Have any studies been done to see if building these biosafety labs actually will boost economic development?
Yes. The University of Texas Medical Branch at Galveston, which is building Galveston National Laboratory, a Biosafety Level 4 facility, hired an independent company, Perryman Group of Waco, Texas, to prepare an economic impact report for the facility. The company found that the Galveston National Laboratory and related initiatives would add nearly $1.4 billion to the gross state product over 20 years and almost 22,500 person-years of employment over 20 years. The Perryman report also estimates that over 20 years the GNL would boost state revenues by more than $71 million and local government revenues by more than $6.6 million.
8. Will the lab serve only the Louisville area?
No, the lab also will serve the Ohio Valley region, an area covering the entire state of Kentucky and southern Indiana, Ohio and Illinois.
9. How significant is it that UofL was selected to build the lab?
Many universities across the country applied to build Level 3 biosafety labs after the National Institute for Allergy and Infectious Diseases announced in 2004 that it would commit a total of $125 million in Fiscal Year 2005. UofL is one of only a handful of institutions selected through a highly competitive process to build a regional lab.
10. What are the physical requirements for a lab built through the NIH program?
The lab must be a stand-alone building at a single site with a size of at least 30,000 square feet. In addition, it must have stringent security controls and either a surrounding 250-foot “buffer zone” or be architecturally hardened to ensure the safety of the general public and environment as well as the integrity of the biological materials inside. The way UofL’s 37,000-square-foot lab is being situated on Shelby Campus will create an ideal buffer zone around the facility.
11. How many researchers will work in the lab?
The lab will be large enough to house six principal research investigators (four resident and two visiting) and 12 post-doctoral researchers. It will be used by UofL scientists, faculty from other schools in the region and regional biotechnology companies.
12. Where will the lab be located?
The lab will be built on a 4.2-acre site at the northeast corner of Shelby Campus. Locating the lab there will not affect other long-term plans for the campus such as the creation of a park-like front lawn along the Shelbyville Road side and an enhanced campus quadrangle.
13. Why Shelby Campus and not some other location?
First, the lab is an excellent fit with the university’s long-term plan for Shelby Campus, which calls for building on UofL’s existing academic strengths and boosting economic development in the region. In fact, homeland security is identified as an area of potential focus in the plan. Second, neither Belknap Campus nor Health Sciences Campus have enough space for an adequate buffer zone and the cost of buying new land would have significantly raised the cost of the project.
14. Does UofL have the expertise to design and build this lab?
Several outside experts have assisted UofL on the project. Architectural and engineering consultant CUH2A helped design the facility. Tetra Tech helped develop safety and security measures for the building. International Commissioning Engineers of Atlanta will test and verify all of the systems in the lab before it opens. All three consultants have practical knowledge working with Level 3 labs.
15. Who is paying to build the lab and how much is it going to cost?
Total cost of the lab is about $34.6 million. The National Institute of Allergy and Infectious Diseases grant is for just under $22 million. UofL is making a 25 percent match of $7.3 million and is providing another $5.3 million for non-federally funded costs such as equipment.
16. How is UofL coming up with its share of the cost?
The university received bonding authority from the Commonwealth of Kentucky to cover its share of the cost.
17. What kind of biological agents will researchers be working with in UofL’s lab?
Initially, UofL researchers plan to study two agents in the facility, tularemia and antibiotic-resistant tuberculosis. Tularemia is a naturally occurring bacteria found mostly in wild rodents and rabbits. It does not easily spread to people and is quickly killed by heat and disinfectants. Antibiotic-resistant TB can be transmitted through the air via droplets from an infected person’s cough, but generally spreads only to someone who has had prolonged close contact with that person.
Other agents will be added as new researchers are recruited and projects develop. UofL will not study any potentially dangerous organism without first assessing the possible risk to researchers, people on campus and community members and ensuring that adequate safety measures are in place.
18. What's the difference between Biosafety Level 3 and Biosafety Level 4?
UofL’s lab will be a Level 3, which is used to study agents that can be transmitted through the air and cause potentially lethal infection. Researchers in Level 3 labs perform work in a strictly controlled environment. Clothing is decontaminated and there are specialized ventilation systems.
Level 4 labs are used to study more dangerous agents, including those likely to cause life-threatening diseases that cannot be prevented, treated or cured. Lab personnel in Level 4 labs are required to wear full-body, air-supplied suits and work in safe, isolated zones within a larger building.
19. Does UofL plan to eventually convert its proposed Level 3 lab to a Level 4?
No. There is a big difference in the nature of the materials handled inside Level 3 and Level 4 labs, and different types of specifications and systems are used in the two levels. UofL’s lab would not be capable of upgrading to a Level 4, and the university does not plan to create a Level 4 lab now or at any time in the future.
20. Will research at the lab involve the use of laboratory animals?
Yes. Animal models are an important part of developing vaccines and cures that eventually can be used in humans. These animals, mostly rodents, will be housed, cared for and contained according to strict federal guidelines to maintain their comfort. There will be no facilities in UofL’s lab for studies involving primates or humans.
21. How are you going to make sure that the lab does not pose a health risk to researchers, people on the campus and members of the community?
The Centers for Disease Control's Office of Health and Safety has said that laboratories working with infectious agents have not been shown to represent a threat to the community. We also put this question to the National Institute of Allergy and Infectious Diseases, which responded with the following written statement:
"The biosafety labs that will be constructed as part of the National Biosafety Laboratory and Regional Biosafety Laboratory programs will be designed and built using the strictest federal standards, incorporating special engineering and design features to prevent microorganisms from being released into the environment and to protect workers in the facilities. There are no recorded incidents involving community contamination from any of the BSL-3 and BSL-4 facilities existing in the United States."
Biosafety labs are highly specialized facilities featuring customized research areas regulated by rigorous standards, devices and procedures. Clothing is decontaminated, windows are sealed and buildings have special ventilation systems that keep microbes contained within the facility. Access is controlled and exhaust air is not recirculated. Gloves, masks and gowns are worn to prevent person-to-person transmission of microbes.
22. What research safeguards are already in place?
UofL has an Institutional Biosafety Committee, a National Institutes of Health-mandated panel made up of faculty members, laboratory technology representatives and community representatives that reviews research involving recombinant DNA and other biological agents. This panel recently received top marks in a survey by the Sunshine Project, a nonprofit watchdog organization that advocates openness and accountability in the field of biological research. Of nearly 400 institutional biosafety committees across the nation surveyed, UofL’s committee placed in the top 5 percent. This same committee will review all research projects taking place in the university’s new biosafety lab.
23. Will having the lab be an asset in training emergency personnel?
Yes. The National Institutes of Health says that regional biosafety labs must be ready to provide facilities, scientific support and expertise to first responders and to support public health efforts in a national biodefense or emerging infectious diseases emergency. UofL will offer specialized training to emergency workers as a result of having the lab, which will help these workers acquire critical skills they might otherwise lack.
24. Will there be tight security for the lab?
Yes. There will be strict security measures, such as requiring researchers to pass through several card-entry, keypad and biometric checkpoints. Access to the facility will be highly restricted. Campus and community law enforcement officers and other first responders will receive special training on security and safety issues involving the laboratory. Security at the facility will not depend upon federal funding. The federal grant UofL is seeking will go toward construction of the lab but will not pay its operating costs. The university itself is responsible for operating the facility and providing security.
25. Could there be an accident in the lab?
Biological research laboratories today are considered to be extremely safe. According to the U.S. Bureau of Labor Statistics, the rate of recordable injury cases per 100 full-time workers in research and testing services dropped by one-third between 1991 and 2001. In addition, the technology used to study biological materials has improved in recent years, so these materials are being stored and used in smaller quantities, minimizing the risk of exposure even in the event of a spill or accident. Finally, the incorporation of new protective equipment such as fume hoods, safety cabinets and glove boxes into research laboratory design and construction has led to unprecedented levels of safety.
26. What is UofL doing to ensure that no biological agents escape from the lab?
The design of the lab plus the rigorous safety and security procedures that will be used there makes the chance of any agent getting out of the lab very difficult. Detailed protocols are being developed to ensure that no biological agent is accidentally transmitted from the lab by air, water, vehicles, lab animals or human contact. Even without these safeguards, the risk of contamination to people nearby is nearly zero.
27. Are there any studies that show a biological agent could spread through the air and harm people in the surrounding area?
No. Research has shown that air currents, temperature, humidity and other environmental factors make it nearly impossible for biological agents to spread through the air and remain concentrated enough to increase the risk of infection.
28. What if a delivery person dropped a package containing one of the agents outside on the loading dock at the facility?
It is highly unlikely that such an accident would pose a risk to anyone, even to the delivery person. The United Nations regulates shipment of biological agents and the Centers for Disease Control and Prevention and other agencies set forth strict rules for labs that handle infectious agents. Also, people authorized to ship infectious agents must be trained and certified every two years.
Before any infectious agent can be shipped, it must be suspended in liquid, packed in a break-resistant freezer vial and placed inside another container filled with dry ice. When an agent is liquid or frozen, it cannot become airborne. Even if an agent did enter the air, the amounts of agents used in the lab are so small that they would immediately dilute to a level too weak to infect anyone.
29. What if a mouse infected with tularemia or antibiotic-resistant TB went missing or got out of the lab?
All systems in the biosafety lab have been designed to keep this from happening. The lab will have a series of sealed entrances. A census of animals will be taken each day. The area holding mice and rats will have a sophisticated escape prevention system. Cages will have three latches, a stainless steel wire bar lid, a filter lid and another device to ensure the cage cannot come off of the rack holding it in place. Cage doors have brush-type sweeps. Euthanized animals are medically sterilized in a device called an autoclave before they leave the facility.
30. What if a vehicle leaving the lab became contaminated with an agent and carried the agent outside onto the grounds or off the property?
All materials leaving the lab in vehicles will be deactivated using chemicals or an autoclave. No waste will leave without first being disinfected and checked. Lab workers will be required to wear special clothing inside the research area and must shower and change into street clothing before they leave. These processes, plus the quick dilution of any agent exposed to the air, virtually eliminates the chance that an agent could harm anyone outside the lab by “hitching a ride” in or on a vehicle.
31. What if an agent leaked into the ground through waste or drain water from the lab?
National Institutes of Health, Environmental Protection Agency and Metropolitan Sewer District regulations will all be in force at the lab. All three agencies prohibit the disposal of infectious waste into the sanitary sewer system or in any other manner that could contaminate groundwater. All plumbing and mechanical systems at the lab will have backflow prevention devices to keep any waste from accidentally entering the sewer system.
32. What if a lab worker were accidentally exposed to an agent and became infected?
The way the lab is being designed, built and operated will greatly reduce this risk. Research personnel will work with agents inside special biosafety cabinets.designed to protect them and their surroundings. Safety training will be provided to workers about the signs and symptoms of infection for each agent. Workers will wear protective equipment and be vaccinated in advance. In the unlikely event a worker were exposed to an agent, he or she would be put under medical surveillance and, if necessary, quarantined.
33. Will the lab make Louisville a target for terrorism?
The list of potential terrorism targets is practically endless: highways and bridges, shopping malls, power plants, municipal water supplies, dams, ports, trains and stadiums. In today’s world, it’s difficult to rule out the risk of a terrorist attack anywhere. However, because researchers in these labs work with such small quantities of infectious agents, terrorists are more likely to look for them elsewhere. In fact, these dangerous organisms are regulated so tightly in the United States that it is far easier for terrorists to obtain them overseas. What’s more, without researchers working to come up with effective ways to fight infectious disease, we will not be able to develop effective defenses against a bioterrorism attack.
34. Will the lab pose any environmental risk to Beargrass Creek?
No. Not only is the site well above the flood plain in the area, but soil erosion controls will be used during construction to protect the creek. Nothing from inside the facility will be discharged into the creek. Lab materials will be thoroughly decontaminated before ever leaving the building. Finally, storm water from the roof, parking lot and other outside areas will go into a detention basin meeting local and state requirements.
35. Will the lab have any other impact on the environment?
The National Institutes of Health has issued a “finding of no significant impact (pdf)” following an environmental assessment of the project. The study examined the potential effects on plants, animals and humans of building and operating the lab. UofL cleared some dormant trees in March at the lab site in a step aimed at protecting the endangered Indiana bat. No bats were seen at the site, but the step was taken anyway to avoid any chance of disrupting the roosting of the federally protected mammal.
36. How will biological materials be transported to and from the lab?
The type of work conducted in this lab does not require frequent movement of biological agents into and out of the facility. Biological agents will be moved into the lab initially according to strict federal regulations and with the oversight of U of L’s Institutional Biosafety Committee. UofL will not transport any potentially dangerous materials to or from the lab unless it can do so while assuring the safety of people who live, work and frequent businesses in the surrounding area.
37. You say the chance of an accident in the lab is highly unlikely, but if a worst-case scenario did occur how would you warn people?
Five emergency warning systems are already in place.
First, if a problem were to develop at the lab, staff would be required to notify the university’s police department by telephone call or electronic monitor. The department would notify Louisville Metro Emergency Management Agency, which would immediately activate the outdoor community warning siren system.
Second, the emergency management agency would activate a cable television interrupt with an alert tone and message indicating that an incident had occurred.
Third, the agency would notify the National Weather Service’s Louisville office, which encourages all citizens and businesses to have a weather radio, and the weather service would activate these radios and make an emergency announcement.
Fourth, the local emergency management agency would activate the Emergency Alert System (formerly known as the Emergency Broadcast System) and send out a message that would be broadcasted by local radio and television stations.
Fifth, a message would be delivered to homes and businesses over Dialogic, Louisville Metro’s computerized emergency phone notification system. A test message UofL sent out on this system March 14 went to 5,800 homes and 1,200 businesses within a one-mile radius of the lab.
38. What is the timeline on the project?
The university plans to begin building the lab in April. Work should be completed in late 2008 and research should begin there by early 2009.
39. What has the university done to let people know about the lab?
UofL initiated community dialogue on the Center for Predictive Medicine even before it applied for project funding.
University officials explained the project to the Louisville Courier-Journal in October 2004, which led to a newspaper article listing a website, e-mail address and phone number where people could get more information. Stories about the lab also appeared on The Associated Press news wire and in The Louisville Cardinal, the university’s student newspaper.
Also in 2004, UofL began offering a web site about the lab with a question-and-answer feature, drawing, proposed site plan and other information. The site has been continually updated as developments have occurred.
Other outreach efforts in 2004 included meetings with mayors and other Shelby Campus area neighborhood leaders, the nearby Home Builders Association of Louisville and the Shelby Campus Community Advisory Board, a group that has advised UofL on its long-term plans for the campus for several years. People in all of these groups were briefed about the lab and encouraged to ask questions and involve others. UofL officials also answered questions about the proposed lab at an open forum in December 2004 that attracted more than 200 people from the community.
When the university learned in September 2005 it had received a federal grant for the lab, it held a news conference and two public forums that month. Since then, UofL has held public forums every few months to update the community.
The university also maintains a current file of information about the lab at the main Louisville Free Public Library at Third and York streets downtown.
40. Will you continue keeping the community informed of this project?
Yes. The university is committed to listening to people in the community and to taking their concerns seriously. We understand that we may not receive unconditional support from everyone. However, we have seen that most people, once they are fully informed, understand and support the vital importance of this lab and appreciate its safety. UofL will keep encouraging community dialogue about this project as it moves from concept to reality.
41. Where can we get more information?
People who have questions about the project can call our community information line at 502-852-1113 or send an e-mail via the “Send Us a Note” feature.