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Frequently Asked Questions (FAQ)
- What is a Regional Center of Excellence for Biodefense and Emerging Infectious Disease (RCE)?
- Why was the UW interested in a Regional Center of Excellence Grant?
- What types of emerging infectious diseases are being studied with the RCE grant?
- What is a Regional Biocontainment Laboratory (RBL)?
- What is the difference between a BSL-3 and a BSL-4 facility?
- Why is the UW applying for an RBL construction grant?
- How much money does the grant provide and how much does the UW have to contribute to building the facility if the grant is awarded to the UW?
- If the UW is already studying these types of diseases, why does the UW need a new, stand-alone building for research?
- Who is in charge of assuring that these laboratories meet current guidelines for safety and security?
- Could an RBL be converted from a BSL-3 to a BSL-4 facility?
- What is the time-line for the RBL grant application award and construction of the new facility?
- Where would the UW build a new facility if it receives the grant? What process is in place to determine the final location?
- What is the UW's plan for informing the public, faculty, students and staff about the project?
- Am I safe with an RBL across the lake from me or within walking distance from my place of work?
- There have been recent reports of laboratory worker-acquired infections at Boston University. What is the UW's track record of such events?
- What would happen to this facility if the United States came under attack by bioterrorists?
- How will infectious agents and materials be moved into and out of the facility?
- Who/what is a Responsible Official?
- What is a select agent?
- How can members of the community learn more about the grant process, what types of diseases will be studied, and what types of safety procedures are already in place to safe-guard the community?
1. What is a Regional Center of Excellence for Biodefense and Emerging Infectious Disease (RCE)?
The National Institute of Allergy and Infectious Disease (NIAID), a division of the National Institutes of Health (NIH) has funded eight regional centers to conduct research on infectious agents. The University of Washington was selected in 2003 as one of these eight centers referred to as Regional Centers of Excellence for Biodefense and Emerging Infectious Disease (RCE), the only one selected on the west coast. The UW RCE includes researchers at the UW campus, Harborview Medical Center, the VA Puget Sound Health Care System, the Fred Hutchinson Cancer Research Center, the Institute for Systems Biology, the University of Idaho in Moscow, and the National Institute of Allergy and Infectious Diseases Rocky Mountain Laboratories in Hamilton, Montana.
While treatments are available for the diseases currently under study at the UW RCE, vaccines to prevent them are not available, and UW researchers' work may lead to the development of such vaccines. The infections that are studied by the UW RCE are ones that occur naturally, and many of these infectious agents are common in our environment. While these diseases tend to have very small incidence, it is important that scientists study them so that vaccines can be developed and treatments improved. Research on these diseases is not a new endeavor, though the commitment by the federal government to understand more fully the disease processes and develop vaccines to counter them on a large scale is relatively new, due in part to the events during 2001.
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2. Why was the UW interested in a Regional Center of Excellence Grant?
Researchers at the UW are among the world's leaders in studying infectious diseases. They receive nearly $110 million a year in federal funding to study various aspects of infectious diseases. Approximately $54 million of this research is conducted on the main UW campus. As one of the top infectious disease research universities in the country, applying for these funds was a logical step for our faculty. The UW also has relationships with other universities and colleges throughout the Washington, Wyoming, Alaska, Montana and Idaho region (WWAMI). Because of this regional presence, the Federal government believed that the UW could help harness teams of experts throughout the Northwest.
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3. What types of emerging infectious diseases are being studied with the RCE grant?
Currently UW researchers are studying Gram negative bacteria. The grant dollars are designated to study the following:
- Francisella tularensis (tularemia): Also known as "rabbit fever," tularemia is usually considered a rural disease. While widespread in animals, only about 200 human cases are recorded each year. Although tularemia is treatable with antibiotics, there are no vaccines available.
- Yersinia pestis (plague): Human cases of plague in the United States are rare, but are typically found in rural areas. Plague is generally associated with bites from infected fleas. Plague can be treated with antibiotics, but without specific antibiotic therapy, the disease can progress rapidly to death. The mortality rate in the United States is about 14 percent.
- Burkholderia pseudomallei (melioidosis): Melioidosis is predominantly a disease of tropical climates and is endemic in Southeast Asia. The disease can be transmitted in several ways, including contact with contaminated soils and water, but only rarely by person to person transmission. It can manifest itself in several ways, including as a form of pneumonia and as an acute bloodstream infection. Antibiotics are effective in treatment, but there is no vaccine for prevention. The recent tsunami in Southeast Asia has increased public health concern regarding this disease.
More information about these infections can be found at the Centers for Disease Control web site: http://www.bt.cdc.gov/agent/agentlist.asp
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4. What is a Regional Biocontainment Laboratory (RBL)?
Research on many infectious diseases requires a very specialized facility. The facility must be built or retrofitted to complex specifications for design, facilities, operations, maintenance, and operating procedures that ensure a high level of containment, or "biocontainment" since researchers are working with biological materials. The Centers for Disease Control and the National Institutes of Health provide containment guidelines, depending upon the types of biological materials under study. These range from biosafety levels 1-4 (BSL-1 to BSL-4). These requirements are designed to provide an environment that maintains safety for the research, the researchers and the adjacent communities. Extra security measures that are not typically found in academic laboratories also contribute to a safe environment in an RBL.
Because the Federal government is encouraging and funding research on infectious diseases that typically require BSL-3 biocontainment, they are also providing construction grants to increase the number of facilities nationwide. Over the past two years, the Federal government has made available grants to assure that each major region of the nation has at least one new RBL facility.
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5. What is the difference between a BSL-3 and a BSL-4 facility?
The Centers for Disease Control and the National Institutes of Health have delineated the differences between BSL-3 and BSL-4 facilities in their book, Biosafety in Microbiological and Biomedical Laboratories. As described therein are specific containment requirements that protect the researchers and areas external to the laboratory itself. These are referred to as primary and secondary barriers. Primary barriers include different types of biological safety cabinets, engineering controls, design of equipment, as well as the type of personnel protective equipment, training, and laboratory practices required. Secondary barriers focus on facility design and construction and include different requirements regarding separation from public access, decontamination equipment, specialized ventilation systems, controlled access, and airlocks for entry.
BSL-3 containment facilities are used for clinical, diagnostic, teaching, research or production facilities where the infectious agents have the potential for aerosol transmission and the diseases can have serious or lethal consequences if treatment is not administered. In addition to the bacteria that are being studied by RCE investigators, other examples of infectious agents that require BSL-3 laboratories include HIV and the bacterium that causes tuberculosis. Such work is already ongoing in existing BL-3 laboratories on the UW campus, Harborview Medical Center, Fred Hutchinson Cancer Research Center, and at other research facilities in Seattle.
In a BSL-4 facility, all BSL-3 requirements must be in place, and in addition, the laboratory worker is completely isolated from the infectious materials by working in full-body, air-supplied positive pressure personnel suits. Complex, specialized ventilation requirements, waste management systems, specialized design and construction standards make BSL-4 facilities a sealed internal shell with multiple levels of protection. BSL-4 facilities are used for work with dangerous and exotic agents (such as Ebola virus or smallpox) that pose a high individual risk for laboratory infections and life-threatening disease or for agents with unknown risks for disease transmission. Because of the complex and specialized nature of these facilities, only a few exist in the United States. The Federal government has recently funded development of a few additional BSL-4 facilities, and now the focus is on additional BSL-3 facilities. There is no plan to build a BSL-4 facility at the University of Washington.
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6. Why is the UW applying for an RBL construction grant?
The UW does not have enough space for its currently funded infectious disease research. The UW is already conducting critical BSL-3 research at various sites throughout the UW; in the past, most of these laboratories focused on HIV or tuberculosis. With the award of the RCE to UW, the existing BSL-3 space is no longer sufficient to permit future growth of infectious disease research. The Federal government has indicated a strong desire to establish an RBL facility on the West Coast. The UW's unique strengths in biotechnology and genomics serve the needs of our regional partners throughout Washington, Wyoming, Alaska, Montana and Idaho (WWAMI), as well as the state of Oregon. This region occupies greater than one-quarter of the landmass of the U.S. With the region's close ties to Canada and links to the Pacific Rim, the Pacific Northwest can play an important role in national biodefense. The UW's growing need for space for infectious disease research, the national interests in this region, and the need for increased emergency public health laboratory capacity in the region make this is a very logical and strategic grant application decision.
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7. How much money does the grant provide and how much does the UW have to contribute to building the facility if the grant is awarded to the UW?
The grant is approximately $25 million. The UW is committed to $8.34 million in matching funds. At this time, the total capital project costs are estimated to be approximately $65 million. An active effort is underway to identify sources for the remaining $32 million needed to fund design and construction.
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8. If the UW is already studying these types of diseases, why does the UW need a new, stand-alone building for research?
While the UW is currently studying these diseases, the ability to further the knowledge gained from this research goes beyond current facility capacity. It is anticipated that there will be more grant dollars available for research in infectious diseases. In order to remain competitive for grants and to take advantage of its strong research capabilities in this area, the UW needs more specialized facilities. Existing UW facilities were constructed years ago. Although they meet current standards for biocontainment, it is difficult to adapt them to security (police, FBI) needs. Renovating existing spaces is difficult and also prohibits the use of those facilities for other types of research that need high levels of containment (such as HIV research), but are not diseases studied by the RCE. It is much more efficient to house research for these types of organisms in one, stand-alone building that is built specifically with the security issues in mind. Such a facility will also help position the UW as a regional leader and provide the maximum in research flexibility to help attract future research dollars to the UW and the region.
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9. Who is in charge of assuring that these laboratories meet current guidelines for safety and security?
The University of Washington's Office of Environmental Health and Safety Department is responsible for oversight of all laboratory research conducted at UW facilities. Specific protocols and procedures are carefully documented and approved before research can be conducted. This office has worked very closely with the RCE investigators to ensure the safety of the ongoing work with infectious agents. The office also worked closely with the investigators who prepared the grant application for RBL funding. Security issues for the RCE and RBL are overseen by the UW Police Department, in consultation with the Seattle Police Department and the FBI.
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10. Could an RBL be converted from a BSL-3 to a BSL-4 facility?
No. The structural requirements for Level 3 and Level 4 facilities preclude a conversion. In addition, the federal funding agency has clearly stated that these construction grant dollars cannot be used for Level 4 facilities. Most importantly, the University does not support building a Level 4 facility or conducting research that requires Level 4 containment.
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11. What is the time-line for the RBL grant application award and construction of the new facility?
The grant application was submitted in December 2004. Applications will be reviewed over the next several months and successful candidates should be notified by late summer 2005. Design and construction of the facilities would take approximately three years and it is anticipated that the facility would open in 2009. This time-line is consistent with large laboratory projects.
While the Federal government is reviewing our grant application, the UW will be working with faculty, students, employees and the neighboring communities to provide information about the facility and the research that will be housed there.
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12. Where would the UW build a new facility if it receives the grant? What process is in place to determine the final location?
The President of the University, Dr. Mark Emmert, has requested a process be implemented whereby three major questions are thoroughly explored:
- Should there be an RBL in the Pacific Northwest?
- Should it be operated by the University of Washington?
- What are the site options available for the facility?
The first two questions will be discussed during the public forums and the last question will be reviewed by a working group being appointed by the Provost. Information from the forums and the work group report will be given to President Emmert for review prior to the May review of the UW application by NIH.
Initial review of the sites available in the UW master plan found only a few areas where it is feasible to construct such a facility on the main campus. The proposed preferred site is to the west of the Bioengineering/Genome Sciences building, just to the south of the West Campus Garage. The final site selection has not been made, and President Emmert will review the report from the working group before he makes a final recommendation.
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13. What is the UW's plan for informing the public, faculty, students and staff about the project?
The grant application included a plan for engaging the public and the University community in discussions about this project. These discussions will work to ensure public and campus-wide understanding of the project, including faculty, staff and students, as well as our neighboring communities. The plan builds on existing relationships and already established lines of communication with our neighboring communities. For example, since 1977, the City-University Community Advisory Committee (CUCAC) has been meeting to discuss the development of new buildings on the Seattle campus and how the change will impact the community.
The development of this grant and the associated building plans will be brought to the CUCAC during each phase of its development, beginning in February 2005. In addition, meetings have already begun with state health officials, the Governor's Office, the Seattle Mayor's Office and other city officials. The UW plans to develop and provide other opportunities for community information sharing throughout planning, design and operation of the facility as well. Two public forums have been scheduled, one on campus in Kane Hall on February 23 at 7:00 p.m., and one in the community at the Magnuson Park auditorium on March 1 at 7:00 p.m.
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14. Am I safe with an RBL across the lake from me or within walking distance from my place of work?
Yes. The UW has a long history of safely working with infectious disease agents and toxins at the biocontainment levels that will be present in this facility. The RBL facilities and equipment will have built-in redundancies to assure several levels of protection. At RBL facilities, the risk is primarily to the researchers however, the personal protection, facility design, and training that researchers undergo minimize that risk.
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15. There have been recent reports of laboratory worker-acquired infections at Boston University. What is the UW's track record of such events?
The recent infections at Boston University occurred in a BSL2 facility and, although the investigation is still ongoing, it appears that the laboratory received a virulent strain of the bacterium instead of the expected weakened vaccine strain. The University of Washington has successfully conducted research at both the BSL 2 and BSL 3 level for years. Based on available data, there has only been one incident at the UW, that occurred more than 20 years ago, when laboratory workers were exposed to a respiratory system pathogen in a BSL2 facility. All workers responded promptly and positively to antibiotic therapy. The high skill level of the researchers, the required operating procedures, and the protective equipment and facilities used, as well as the safety training received provide a framework where the chance of a laboratory acquired disease is minimized to the greatest degree possible.
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16. What would happen to this facility if the United States came under attack by bioterrorists?
The RBL would be part of the national bio-defense network. If the United States were to face a major bioterrorist event, one of the first national needs will be for sufficient laboratory capacity to conduct screening and confirmation tests in order to define the scope of an attack. As part of the requirements for utilizing federal funds, the RBL laboratory would be available to assist public health officials in the event of a major public health disaster, including a bioterrorism emergency. In 2001, the anthrax attacks on Congress resulted in a deluge of "white powder" incidents throughout this region, but there was little laboratory capacity available to enable officials to respond adequately to the public's questions. Development of RBLs is intended to make the nation, as well as the region, more responsive to such incidents in the future.
More important than an attack by bioterrorists is the fact that there are emerging infectious diseases that could present a significant public health emergency should widespread epidemics occur. RBLs throughout the country will provide scientific expertise as well as support facilities to the public health efforts of the region in the event of any major infectious disease emergency. If such an emergency occurs, it is anticipated that the existing public health laboratory capacities would be quickly overwhelmed, and assistance from an RBL would be extremely important. The Washington State Department of Health (DOH) supports the UW's RBL grant and the critical role such a facility could play in helping to ensure the health of our region. The UW already works closely with DOH on a number of public health issues through the UW School of Pubic Health and Community Medicine, the Environmental Health and Safety Department, as well as through ongoing relationships with the UW's two medical centers.
Additionally, plans and preparations would be developed to address security issues should the facility itself ever come under attack. RBL facilities are required to assess risks and develop confidential security plans responsive to any potential threats. The facility will be built to include biometric screenings and restricted access. The building will be designed and constructed in a manner to prevent violent entries.
The UW's jurisdictional police force (UWPD) is located adjacent to the proposed building site, adding an additional level of security. Extensive training and networking are planned for all first-responders who service the UW campus. Because this project will be part of a national effort, federal involvement from the FBI and others could be anticipated in the event of a major emergency.
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17. How will infectious agents and materials be moved into and out of the facility?
The United States Department of Transportation has specific requirements for the shipping and transporting biohazardous materials. In addition, there are specific requirements for receiving, monitoring, and inventorying biohazardous materials that would be used in a RBL facility. Staff trained in both transportation and biosafety requirements will be located at this site and will be responsible for ensuring that we meet, and when possible, exceed the safety protocols. All activities conducted in such a facility are carefully monitored by the Responsible Official and biosafety officers from the Environmental Health and Safety Department. These measures are already in place in the existing laboratories at UW.
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18. Who/what is a Responsible Official?
Federal law (42CFR 73 and 42 CFR Part 1003) requires any institution that undertakes research with any of the infectious diseases or toxins identified by the Federal government as "select agents" must identify and authorize an individual as the Responsible Official. This person is the point of contact between the institution and the Federal government's select agent program and ensures management oversight of the various safety, security, and operational requirements set forth in federal law. At the UW, that person is the Environmental Health and Safety Director. In addition, two alternate Responsible Officials have been designated to provide constant oversight of the research and facilities.
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19. What is a select agent?
"Select agent" is the term given to certain viruses, bacteria, fungi, and toxins that have been identified by the Centers for Disease Control as having the potential to pose a severe threat to public health and safety. The list is reviewed routinely and can change over time. The list contains a wide variety of agents such as exotic Ebola viruses as well as staphylococcal enterotoxin, commonly associated with food poisoning. Depending on the agent, certain biosafety precautions must be used, and all research done with any of the agents comes under specific Federal requirements for work with these materials, including federal background checks of the researchers conducting the research.
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20. How can members of the community learn more about the grant process, what types of diseases will be studied, and what types of safety procedures are already in place to safe-guard the community?
Information about the RBL will be available through a dedicated web-site, e-mail address and mailing address. In addition, the University's Environmental Health and Safety Director and/or the Biosafety Officer (206-543-7262) as well as the Office of University News and Media Relations (206-543-2580) can be contacted for general information at any time. Because of mandated security some specific information must be protected, but it is the UW's intention that the RBL development process be an open dialogue to ensure that the community understands the need for the facility and the steps that will ensure safety and security. It is very important to stress to all that the research that will be conducted in this facility is an expansion of what is already occurring at sites throughout the UW.
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