About the Laboratory A1. What is the Ricketts Laboratory? The Ricketts Laboratory will be a highly secure and safe infectious disease research facility, built and operated by the University of Chicago, funded by the National Institute of Allergy and Infectious Disease (NIAID), and sited on land owned by the U.S. Department of Energy at Argonne National Laboratory, southwest of Chicago. NIAID is one of the National Institutes of Health. The Ricketts Laboratory is designated a Regional Biocontainment Laboratory (RBL) under NIAID's biodefense initiative announced in the second half of 2002. NIAID’s biodefense network includes support for the design and construction of thirteen laboratories as regional resources for research and development of improved defenses against emerging and re-emerging diseases and naturally occurring pathogens that could be used as weapons. The biodefense network also includes two National Biocontainment Laboratories. National Biocontainment Laboratories will study the most severe pathogens, while Regional Biocontainment Laboratories like the Ricketts Laboratory will only conduct research on pathogens for which treatments are available. The Ricketts Laboratory will support the Great Lakes Regional Center of Excellence for Biodefense and Emerging Infectious Diseases Research, a consortium of research institutions in the upper Midwest that is also funded by NIAID. Back to Top A2. What is a Regional Center of Excellence, an RCE? Regional Centers of Excellence for Biodefense and Emerging Infectious Diseases Research are consortiums of research institutions in federally-designated regions. Their goals are to train researchers; to find better ways to detect, prevent and cure infectious diseases, in the form of diagnostics, vaccines and therapeutics; to collaborate with diverse approaches and techniques; and to assist in response to local, regional, or national crises involving infectious diseases, whether occurring naturally or caused by terrorists. The Great Lakes RCE is in the federally designated region V consisting of Illinois, Indiana, Michigan, Ohio, Minnesota, and Wisconsin. It has 22 member institutions -- those members are: The University of Chicago, Northwestern University, Argonne National Laboratory, Battelle Memorial Institute, Illinois Institute of Technology, Illinois Institute of Technology Research Institute, Illinois State University, Loyola University of Chicago, Mayo Clinic, Medical College of Wisconsin, Michigan State University, National Wildlife Health Center, U.S. Department of the Interior, Purdue University, the University of Cincinnati, the University of Illinois at Chicago, the University of Illinois at Urbana-Champaign, the University of Michigan, the University of Minnesota Twin Cities, the University of Minnesota at Duluth, the University of Notre Dame, the University of Wisconsin-Madison, and the University of Wisconsin- Milwaukee. Back to Top A3. Why do RCE's need Regional Biocontainment Laboratories? Research on emerging and re-emerging infectious diseases and potential bioterror agents requires specialized laboratory facilities in addition to those available at the campuses of the RCE members. The RBLs and the more highly specialized National Biocontainment Laboratories provide those facilities. In addition, the RBLs will be major resources for academic institutions, biotechnology and pharmaceutical firms that are not members of the RCEs and will train researchers, physicians, and first responders to be prepared in the event of an infectious disease crisis or biodefense emergency. Back to Top A4. Would a Regional Biocontainment Laboratory work on developing or making biological weapons? No. The research at a RBL will develop new methods of prevention, diagnosis and detection, and treatment of diseases that have been difficult to study because of the scarcity of appropriate facilities. Back to Top A5. What are NIAID's requirements for building RBLs? The National Institutes of Health required that institutions proposing regional laboratories: Maximize safety. Apply the most stringent interpretation of the federal guidelines for design and operation of biocontainment facilities. Provide 100% redundancy for mechanical, electrical, and plumbing systems to meet the safety needs of the occupants and the community. Maximize operational effectiveness. Maximize reliability and flexibility for adapting to future needs. Maximize interaction and collaboration by scientists. Back to Top A6. What is the difference between a Regional and a National Biocontainment Laboratory? A Regional Biocontainment Laboratory typically serves a part of the country (one of the ten federally-designated "regions" of the country) and is limited by design, construction and federal certification to handling agents that require "Biosafety Level 3" (BSL-3) safety and security standards. The National Institutes of Health's NIAID is initially funding nine RBLs. A National Biocontainment Laboratory (NBL) serves the entire country and is equipped to handle more dangerous infectious agents requiring "Biosafety Level 4" (BSL-4) facility standards. NBLs are substantially more costly and complex than RBLs. The NIH has committed to funding two NBLs. BSL-1, BSL-2, BSL-3 and BSL-4 are designations of hazard control requirements that correspond to the characteristics of pathogens, such as the severity of the disease they cause, the route of infection (airborne or not) and the availability of preventive vaccines and effective medical treatments. BSL-1 requires the least hazard control and BSL-4 the most. Many universities and research institutions have BSL-1 and BSL-2 laboratory facilities; BSL-3 and BSL-4 facilities are more scarce, more costly, and have more rigorous safety standards. The most stringent interpretation of Biosafety Level guidelines will govern the construction and operation of RBLs and NBLs. Their safety levels will also determine what can be studied at them. A BSL-3 facility, such as an RBL, conducts research with infectious agents for which there are already some treatments available; a BSL-4 facility, such as an NBL, conducts research on infectious agents for which there is presently no known treatments. (For further information on Biosafety Levels, see FAQ E5.) Back to Top A7. What are "emerging and re-emerging" diseases? Emerging diseases are those about which very little is presently known because of their relatively recent appearance. As recently as 30 years ago, for example, AIDS was an unknown disease. As recently as 10 years ago, West Nile virus was not found in the United States. Re-emerging diseases are those caused by bacteria and viruses that have become resistant to existing treatments, such as some strains of tuberculosis, influenza, streptococcus and E. coli. Back to Top A8. If treatments for a disease already exist, why do we need to do more research? Known species of bacteria and viruses evolve and adapt, diseases migrate to new populations and exploit new environments, and new species and varieties of bacteria and viruses regularly appear. Just as there is a new flu vaccine each year, we need to build on our knowledge of other diseases to maintain our defenses. With these challenges, we need to be able to investigate cures methodically. In the past, finding cures and preventatives has often been serendipitous. Now we have tools to make our search a matter of understanding rather than being hit-or-miss. Back to Top A10. Specifically, what bio-agents does NIAID ask be studied at a regional laboratory? The list of organisms that could be studied at a Regional Biocontainment Laboratory is extensive. The federal government has identified a categorized set of fewer than 30 agents of high priority for research with regard to biodefense and emerging disease (http://www.bt.cdc.gov/agent/agentlist-category.asp). Of these, the proposed Ricketts Laboratory would likely focus on only three to six at a time. The organisms studied at Ricketts would be partly dictated by the science proposed and accepted through the Great Lakes RCE. Other work at the Ricketts Laboratory may be executed by qualified researchers and institutions in the region, or by scientists responding to a regional or national biodefense emergency. The diseases presently considered for work in the facility include anthrax, Dengue fever, influenza, plague, botulism, tuberculosis, tularemia, and West Nile virus. Researchers are expected initially to concentrate on anthrax, plague, tularemia and Dengue fever. Much of the research will use small, non-infectious pieces of pathogens, such as surface proteins or genes that might be useful in developing vaccines or therapeutics. Back to Top A11. What makes a Regional Biocontainment Laboratory different from other BSL-3 laboratories? There are hundreds of biocontainment facilities around the country of varying sizes and levels that exist for various purposes. (Hospitals, for example, often have specific laboratories designed to contain infectious materials.) These facilities, many in urban areas, have a superb record of safe operations, both for their workers and their neighbors. However, most of these facilities are not qualified to support research as outlined by the National Institutes of Health. A shortage remains of appropriate facilities to meet accelerating concerns about emerging and re-emerging diseases and agents of bioterrorism. Key elements that make an RBL distinct are its active recruitment of expert researchers around the region, its superior technological resources, its efficiency in operation, and its commitments to training researchers and personnel responsible for public safety, and to promptly responding to national or regional needs. The likelihood of discovery of diagnostic tools, vaccines and antibiotics are greatly improved by the interdisciplinary exchanges planned for in such a facility. Back to Top A12. Where should Regional Biocontainment Laboratories be built? Couldn't they be at a university or a hospital? There are no requirements regarding the location of Regional or National Biocontainment Laboratories. They may exist in an urban, suburban or rural environment. However, rigorous construction requirements must be met, and some locations may lend themselves more readily to meeting these requirements. As to being located at universities and hospitals, some are being planned for such institutions, and many universities and hospitals already have areas designed to contain infectious agents that serve the researchers on their particular campuses. Hospitals and public health laboratories, in fact, routinely handle clinical samples without knowing what microorganisms are causing patient symptoms. However, the location at Argonne has significant advantages because, while in close proximity to Chicago and centrally located in Region V, it also can provide well-established, complementary research tools, staff, and security. Back to Top A13. Were other potential locations mentioned in the proposal? No. The institutions submitting proposals were required to propose a single construction site and describe its relationship to existing infrastructure and support services. Back to Top Planning for the Ricketts Laboratory B1. What did the University propose and who else is involved? The University of Chicago proposed that a Regional Biocontainment Laboratory be built and operated at a site leased from the federal government at Argonne National Laboratory. The university also led, with Northwestern University, the formation of a consortium of leading research institutions in the upper Midwest into a Regional Center of Excellence. The University coordinates the research and support by the Great Lakes RCE members which are: Argonne National Laboratory, Battelle Memorial Institute, Illinois Institute of Technology, Illinois Institute of Technology Research Institute, Illinois State University, Loyola University of Chicago, Mayo Clinic, Medical College of Wisconsin, Michigan State University, National Wildlife Health Center, U.S. Department of Interior, Northwestern, University of Chicago, University of Cincinnati, the University of Illinois at Chicago, the University of Illinois at Urbana-Champaign, the University of Michigan, the University of Minnesota at Duluth, the University of Minnesota Twin Cities, the University of Notre Dame, the University of Wisconsin-Madison, and the University of Wisconsin-Milwaukee. Back to Top B2. Who is responsible for this initiative at the University of Chicago? Scientists and administrative leaders at the University, including the president and the Board of Trustees, collectively recognized this opportunity to participate significantly in advancing our nation's ability to prevent, diagnose, and treat infectious diseases, and in assisting regional agencies to prepare for and respond to any large scale infections arising from natural, accidental, or malicious acts. While specific scientists brought the opportunity to the attention of University officials, the proposal is institutional, not personal.Dr. Keith Moffat, the University of Chicago's Deputy Provost for Research and Member of the University of Chicago Board of Governors for Argonne National Laboratory, was designated as the Principal Investigator. Professor Olaf Schneewind, Professor and Chair of the Department of Microbiology, is principal investigator for the related Great Lakes Regional Center of Excellence and for the Ricketts Laboratory. Joseph Hamm is university project manager for design and construction of the Ricketts Laboratory. Back to Top B3. Why was Argonne chosen as the location for the RBL? There are many reasons why Argonne is an ideal site for the proposed regional laboratory. Argonne already has unique facilities and capabilities to support infectious disease research. o The Advanced Photon Source (APS), the most brilliant source of hard X-rays in the western hemisphere. o The Structural Biology Center at the APS, which allows exceptionally rapid analysis of the structures of proteins relevant to disease (thus allowing timely design of vaccines and treatments). [See anthrax protein structure illustrated on the Home Page] o The Midwest Center for Structural Genomics, an Argonne-led consortium of seven research institutions that focuses on application of robotics for rapid selection, generation, purification, and crystallization of proteins, along with high-speed computational and imaging methods. o Mathematics and Computer Science Division, offering extraordinary capabilities in computational analysis and modeling of protein structures and their functions. o Center for Nanoscale Materials (nearing groundbreaking), which links emerging knowledge about nano-scale materials to biological research (At the nano-scale, where sizes are measured in nanometers, properties of materials often differ from what we normally expect. One billion nanometers equal one meter or about 39 inches). Argonne has extensive expertise in managing large, specialized research facilities; and each year Argonne supports thousands of researchers from many U.S. states and foreign countries, who come to use these facilities. Access to Argonne's site is tightly controlled and site security is excellent. Argonne has been operating for more than 50 years, including the use of hazardous materials, and has an excellent safety record. In fact, Argonne is a major resource of technologies for the proper handling of hazardous materials and for environmental cleanup. Back to Top B4. While there are advantages to associating this new facility with Argonne, did the proposal analyze using current technologies to maintain close collaboration between Ricketts and Argonne without being in the same site? One of requirements established by the National Institutes of Health (NIH) was to construct a physical facility to promote "interaction between scientists and promote a collaborative work environment." Accordingly, the proposal described a situation to facilitate timely, interactive face-to-face communication about results and plans among personnel at the Ricketts Laboratory and the scientists at the 22 institutions in what is now the Great Lakes RCE, and among the scientists at the various related Argonne facilities. A large portion of such communications will occur at the Ricketts Laboratory, as scientists from all involved institutions gather at the central research facility and conduct experiments requiring specialized personnel, equipment, and protection. Back to Top B5. What is the timeline for building the Ricketts Laboratory? Milestones in the construction timeline for the Ricketts Laboratory include: November 2005: Completion and approval of construction documents March 2006: Begin site clearing and preparation December 2007: Complete construction March 2008: Complete commissioning, move-in, and demonstrate operational readiness Back to Top B6. What are some of the specifics of the RBL plan? The Ricketts Laboratory is to contain 38,800 gross square feet (? net square feet) of laboratory and support space and cost about $30 million. It would be located near the building that houses Argonne National Laboratory's Biosciences Division. It is being designed by Flad & Associates, an architectural firm with more than 20 years of experience building biocontainment and other specialized scientific facilities, and Affiliated Engineers, Inc. The architectural and functional design will provide multiple levels of containment and access control. The design and operational plans will ensure that all potentially infectious materials, including work clothing, are sterilized by heating or chemical treatment before leaving the building. This is to prevent exposure of adjacent facilities or the public to pathogens being studied. All exhaust air from the areas where BSL-3 pathogens are handled will pass through two highly efficient filters to capture microbes that may become airborne during handling in specially designed biosafety cabinets. The exhaust system includes spare filters and fans to allow continuous operation that will not be uninterrupted by maintenance activities. Only part of the Ricketts Laboratory is designed for Biosafety Level 3 work. The lab will be compartmentalized according to the level of risk required for the performance of job duties. There will be general office space for administrative and facilities staff who will support the operation of the laboratory, and Biosafety Level 2 work for research requiring lower levels of biosafety. Back to Top B7. What is architect Flad and Associate's background in this area? Flad & Associates is one of the most experienced and prolific designers of biocontainment facilities in the country. Flad has designed infectious disease laboratories for corporate, academic, non-profit and government clients throughout North America, including San Francisco, California; Oakland, California; Seattle, Washington; Ames, Iowa; St. Louis, Missouri; Rochester, Minnesota; Madison, Wisconsin; Chicago, Illinois; Memphis, Tennessee; Gainesville, Florida; Tampa, Florida; Atlanta, Georgia; Baltimore, Maryland; Washington, D.C.; New York City, New York; Rochester, New York; and Toronto, Canada. Back to Top B8. Who is Howard T. Ricketts? Dr. Howard T. Ricketts (1871-1910) was a University of Chicago microbiologist who did research on infectious diseases in the late 19th and early 20th centuries. He isolated the organisms, later named for him (Rickettsia), that cause Rocky Mountain spotted fever and typhus. In honor of his achievement in scientific endeavor, as well as his lifelong interest in public health, the University of Chicago has named the planned Regional Biocontainment Laboratory for Dr. Ricketts. Back to Top Assessments and Operations C1. Who will conduct and approve the environmental studies for the Ricketts Laboratory? An environmental assessment has been prepared by the Environmental Assessment Division at Argonne, which is noted internationally for its contributions to evaluating environmental situations and contributing to remediation. The assessment's conclusions will be verified and approved by NIH as the agency funding construction. DOE, which will have the facility on its property, will also approve the assessment as a cooperating agency. Construction will not go forward until the environmental assessment is completed in accordance with all acceptance criteria. The analysis, which looks at all phases of the laboratory's impact on the surrounding area - including such concerns raised by Argonne's neighbors as health implications and impact on real estate values -- continues a process that began in conjunction with the initial design proposals. Since the RBL has been designed to meet stringent safety and environmental standards for a facility of this sort, it is expected that its construction and operation will have little or no impact on Argonne employees and its neighbors. The environmental assessment process is expected to take until late 2005. Back to Top C2. What form will building-specific security take? Terrorist and other malevolent actions/threats are part of ongoing evaluations of all security interests at Argonne, and safety and security were guiding principles in the proposed design for the Ricketts Laboratory. Safeguards and security personnel have been a part of the protection planning process from the earliest stages of its development. This formal and detailed process is based on the best classified and unclassified intelligence available. Protection strategies and equipment proposed for the Ricketts Laboratory meet or exceed established requirements, demonstrating the commitment of the University of Chicago and Argonne National Laboratory to the safety of employees and surrounding communities. Personnel working in the laboratory will be fully screened and thoroughly trained. While Argonne does not publicly comment on specific security measures for obvious reasons, because of Ricketts' principles, operating procedures, and the experience of the researchers and engineers involved, the Ricketts Laboratory will be secure for its employees and neighbors. Back to Top C3. What arrangements are being made to ensure the safety of the Ricketts Laboratory? Safety was a guiding principle in the design of the laboratory. Its design is based on detailed protective guidelines for design and construction of biocontainment laboratories set forth by the National Institutes of Health and the Centers for Disease Control. These guidelines include controlled air flow, high efficiency air filters and decontamination systems. All aspects of the facility will be certified regularly by several regulatory agencies. Back to Top C4. What are the protocols for keeping track of bio-agents while you have them? Each transaction involving biohazardous material will be conducted in accordance with federally-established procedures for packaging, transports and inventory management. These procedures require the sender and receiver to communicate in a detailed fashion and countersign a shipping certificate. All personnel with access to biohazardous material must be authorized by the United States Department of Justice. Existing inventories must be checked in accordance with stringent federal regulations. The University of Chicago has already established a secure inventory management process that will be adapted for use at the Ricketts Laboratory. ANL experts will be available to provide the site's experience and expertise in inventory management of hazardous materials. Back to Top C5. How would biological materials be transported to the Ricketts Laboratory? Standards for the packaging and safe transportation of biohazardous materials are well-established by the federal government and would be carefully observed. The Ricketts Laboratory will not accept shipments that do not meet these standards. Packaging regulations require multiple levels of containment in sealed containers and the inclusion of safe absorbent material. Packaging standards were developed by the federal government in consideration of potential collisions, including typical stresses on packages transported by airplane and truck around the world. Explicit labeling on the outsides of packages declares all of the hazardous materials within. Violating the standards for shipping, receipt and possession of biohazardous materials carries severe civil and criminal penalties. Shipments will be transported by carriers that are approved by the United States Department of Justice and follow federally regulated guidelines for safety and security. Shipments received by the laboratory will be taken directly to the Ricketts Lab, and not to a central receiving facility at Argonne. Back to Top C6. What would be done with shipments that fell short of shipping standards? Would they be sent back or taken in and tested for hazardous content? Shipments that do not meet standard shipping regulations will be quarantined for examination and investigation. If the package originated with a known supplier, but does not meet laboratory receipt standards, it will be returned provided its return transportation poses no risk to handlers. If the origin of the transportation is not clear, and/or there is any concern the package is hazardous, the shipment will be handled within the facility by the appropriate federal agencies. The facility will train employees in the procedures for responding to such situations. Back to Top C7. What if a carrier bringing in a package of biohazardous materials has an accident? A release associated with a vehicular or mail-transport accident is extremely unlikely. First, the packaging of biohazardous materials is exceptionally secure (see FAQ C5.). Second, because the Ricketts Laboratory will be neither a production facility nor a facility for weapons research, the amounts of organisms that will be handled there will be small--equivalent to the milligram-or-smaller samples presently shipped to laboratories by hospitals and clinics all over the world. However, appropriate decontamination procedures for accidents involving biohazardous materials are well- documented and employees of the laboratory would be trained for any accident. Back to Top C8. How would materials be transported between the laboratory and other Argonne facilities, such as the APS and Biosciences? Local transfers will be handled according to the same strict protocols governing outside transportation to the laboratory, though such building-to-building transportation normally would be non-infectious because organisms would be reduced to proteins and nucleic acid fragments for study. Back to Top C9. What quantities of research materials would be at the laboratory? Research at the proposed Ricketts Laboratory will require only small amounts of organisms. Vials brought to the laboratory would be hand-sized, perhaps the dimensions of a small prescription medicine container, and contain milligram amounts of material (29,000 milligrams equal one ounce in weight). Small amounts of stock material would be used to grow only the bacteria or virus required for each study. Back to Top Impact on the Surrounding Community D1. Will the Ricketts Laboratory be safe for neighboring communities? Concerns in this area are understandable and every precaution will be taken to confine experimental materials to designated research areas. Quantities of these materials will be measured in milligrams and the facility will be designed so all air leaving the laboratory will be filtered and all items carried or worn will be sterilized. Plus, instead of using the full microbe, much research will use small, non-infectious pieces, such as surface proteins or genes that might be useful in developing vaccines or therapeutics. Redundancy in the design of equipment for biocontainment will make the impact of systems failure or damage to individual components miniscule. Plus personnel will be trained to be aware of even such small possibilities of release so they can be prevented. The laboratory is being designed to resist fire and storms but, in the unlikely case of damage to the Ricketts laboratory, the cause of that damage would likely destroy or dispersed pathogens to the point where they would not be a danger (see FAQ D2). Note that the scientists who will be doing and supporting the research will have offices far closer to the research areas than any residential neighbor. A detailed study of biocontainment equipment, operating procedures, and worker training will be a key part of the environmental assessment being conducted. Back to Top D2. What if there is a release of a biological agent from the laboratory? The exterior and interior construction of the building, rigid operating requirements, worker training, equipment monitoring systems, and security are all designed to prevent any releases. Multiple levels of complementary and redundant physical barriers and operational rules will be provided so each possible fault will have built-in backups. Even in the unlikely case of a release, the amount of material would be limited because the RBL would store and handle only very small quantities of infectious materials. Light, oxygen and other environmental elements are destructive to many infectious agents, and such agents are likely to have short survival times outside of the controlled laboratory. Any of the small amounts of viable agents that escaped would likely be dispersed and diluted to levels that would not cause infection. These factors, plus many others, will be examined in accordance with stringent DOE and NIH requirements in the pre-construction environmental assessment to evaluate risks to people within Argonne's site and to local residents, all of whose homes are at least a mile from the proposed RBL. The effects of any suspected release, no matter how small, will be managed by a comprehensive emergency management plan that will be integrated with Argonne's existing plans and practices. In general, emergency response plans for releases of biological agents include assuring the availability of appropriate antibiotics and decontamination chemicals, the availability of specially trained personnel, timely notification and instructions for nearby employees, off-site residents, and local units of government, and prevention of the spread of infection by potentially contaminated personnel and items. The plan established specifically for Argonne will be similar to those long in-place for a hospital or other clinical facility, with methods of decontamination and treatments for possible exposure on hand for workers and the public for each organism studied in the facility. In addition, employees will be trained to recognize and report any suspected problem and to react swiftly to ensure the safety and security of the facility and its neighbors. Back to Top D3. What happens to bioagents when research on them at the laboratory is complete? When research on bioagents is complete, they will be destroyed. The RBL design provides that everything leaving the laboratory (air, water, tools, and clothing) would be thoroughly cleaned and sterilized to prevent any infectious materials release. This preventative design includes provisions for necessary disinfection and cleaning facilities. All areas in which hazardous microbes are present would be rigorously and routinely cleaned to protect workers, as well as to avoid cross-contamination that could affect research results. Back to Top D4. What impact will the laboratory have on home values? The possibility of an effect on property values was evaluated by Argonne’s Environmental Assessment Division and determined to be unlikely. In general, facilities that might be viewed as potentially hazardous by the public can sometimes affect property values in one of two ways: reduced values if the facility is thought to pose a health risk, or increased values due to workers’ desire for proximity to the workplace. The impact of BSL-3 labs on surrounding property values has not been studied in depth. Therefore, to predict the effect of the Ricketts Lab on surrounding property, value trends for residential property adjacent to BSL-4 laboratories in the U.S. were evaluated. These trends suggest that construction and operation of BSL-4 laboratories in residential areas does not result in lower property values. The construction of BSL-3 labs, such as the Ricketts Lab, is similarly expected to have no effect on property values. Back to Top D5. Will construction of the Ricketts Laboratory interfere with traffic on roads surrounding Argonne? The addition of 150 workers during construction and 50 employees during operation will have minimal impact on congestion on the roads to Argonne or at the gates of Argonne. Construction traffic may cause short delays on roadways within the Argonne site. Back to Top D6. What are the benefits to local communities of having the Ricketts Laboratory located nearby? The Regional Biodefense Laboratories will be centers of research on infectious diseases, targeting both those that might occur naturally and those spread by bioterrorists. In addition to being part of the national biodefense initiative of the National Institutes of Health, it will be a local resource for training first responders and in case of a disease outbreak in the area. In case of an outbreak, it would be used to identify pathogens and as a source of information for the public. The initiative, itself, is intended in part, to improve state and local health systems and their ability to cooperate with the federal government in response to a biodefense emergency. The University of Chicago's proposal specified educating key public officials and first-line responders, as well as pledging to halt ongoing research work to assist in the event of serious regional or national needs. The plans include direct relationships with state offices and laboratories of public health as well as hospitals in the upper Midwest. Infectious disease experts in six states are associated with the proposed Ricketts Laboratory, and they would be responsible for maintaining readiness for and responding effectively to biodefense emergencies. These experts include physicians, university faculty, and state and county health officials in the region. Back to Top D7. Would workers at the laboratory be vaccinated? Yes, where appropriate. Back to Top D8. How long will it take to develop safety protocols for a biological laboratory such as this? Strict national protocols already exist. The National Institutes of Health requires that Regional Biological Laboratories be built to the most stringent interpretation of BSL-3 guidelines, and the university's plans conform to that requirement. Members of the Great Lakes Regional Center of Excellence have substantial experience operating biocontainment facilities and developing the necessary protocols. This will further ensure the safety of RBL employees and neighbors. Operating and training protocols must be in place before the responsible national agencies can provide certification for operation of the laboratory. Back to Top D9. Will animals be used for testing? Yes. Often, initial experiments on bioagents can be conducted in animal cells grown in culture. However, understanding how infectious agents reproduce in a living body and cause disease requires studies on whole animals. Therefore, the Ricketts Laboratory has provisions for using small rodents to test the effectiveness of new approaches for prevention, detection and treatment. New legislation has changed the way scientists can turn new scientific discoveries into new products. The changes include the new FDA animal rule, a significant change in the way FDA approves products. This new rule greatly increases the need for animal research facilities. The path to FDA approval for drugs against bioterror agents is unique. Controlled studies of clinical effectiveness in humans are impossible, since large groups of people are not typically exposed to these diseases. Instead of relying on human studies, the animal rule allows the FDA to approve drugs that are shown to be effective in two animal models, without clinical trials for effectiveness, under the following conditions: - Human efficacy trials are not feasible or ethical - Efficacy is shown in well understood animal models - Efficacy is substantiated in multiple species - Human clinical data on safety, toxicity, and immunogenicity is still required The University of Chicago animal care and use program is accredited by AAALAC International (Association for Assessment and Accreditation of Laboratory Animal Care). Moreover, all animal experiments would be approved by the University's Institutional Animal Care and Use Committee, which applies the highest standards of humane animal care and use as established by the NIH. Back to Top D10. Will people at Argonne be reassigned to this laboratory or will there be new people hired from outside? The Ricketts Laboratory will be a "user facility," which means it will have both a resident staff and visiting researchers from elsewhere in the region and the world. Resident staff will be employees or contractors of the University of Chicago, although some may come from Argonne National Laboratory. Argonne employees will be present in the Ricketts Laboratory primarily as scientific users of the facility. Back to Top D11. What kind of jobs will the new facility create? How will applications be taken? The Ricketts Lab will create employment opportunities in the region. Construction of the lab will directly create approximately 100 jobs and indirectly create an additional 130 jobs during the construction year. During operation, the lab will directly create 30 jobs and indirectly creat an additional 160 jobs. Lab staff during operations will include administrative staff, scientists with doctorate degrees, veterinarians, research support personnel, and facilities personnel. Staff and visiting users will be restricted to specific types of work and areas within the building, and will require rigorous training to meet strictly enforced safety protocols. How applications will be taken will be announced when it becomes time to hire. Since some employees will work for the University of Chicago and others for various contractors, we assume that the process will depend on the entity hiring. Back to Top D12. If this is a University of Chicago laboratory on an Argonne National Laboratory site, will the University or Argonne administer it and which would be reporting on its activities to neighboring communities? The University of Chicago would solely administer the Ricketts Laboratory, working closely with Argonne. The director of Argonne National Laboratory would advise the Argonne and neighboring communities of developments. And NIAID will be a source of information about the most notable scientific accomplishments in the national and regional biocontainment centers. (See FAQ D16) Back to Top D13. What notification policies will be in place to advise residents in case of an accidental or malicious release of pathogens into the air or water supply? Argonne National Laboratory would promptly notify the DuPage County Office of Emergency Management and Homeland Security of any significant incident in accordance with its existing DOE-approved comprehensive emergency management plan. Argonne's emergency planning is very closely integrated with the emergency response plans for both DuPage County and the State of Illinois. The DuPage County Office of Emergency Management and Homeland Security has enhanced capabilities to quickly contact residents in the area surrounding Argonne. DuPage County also has a direct link to the DuPage County Forest Preserve Rangers to initiate protective actions in Water Fall Glen. Further, Argonne National Laboratory has the authority and capability to unilaterally direct the Forest Preserve to take specified protective actions if it is expeditious to do so. The plans provide for response teams and prompt communication with other local and regional governments and agencies. They also provide for an Emergency Press Center to provide information to the media and the public. The press center works closely with an Emergency Response Center manager to monitor and assess developments, and to prepare and distribute communications to employees, the public, and the news media. Employees would be notified of protective actions they are to take via onsite public address system announcements. Back to Top D14. Who would provide emergency services for the Ricketts Laboratory? How would it affect taxes and community services? Argonne National Laboratory already has fire and hazardous material response capabilities and medical services on its site, and these groups would be the first responders to the Ricketts Laboratory. The University of Chicago Hospitals and other nearby hospitals have appropriate facilities and substantial experience in treating infectious diseases and could be used for treatment, as appropriate. The Ricketts Laboratory would place little if any extra demand on area hospitals and services. Communities would benefit from training available through the laboratory for their community services organizations which might have to in respond to infectious disease emergencies. Note that emergency response teams based at Argonne provide support for emergencies throughout the area and, in some cases, the nation. Back to Top D15. What happens if a fire or a tornado were to affect the Ricketts Laboratory, or if the facility is otherwise damaged? The laboratory is designed to resist natural and man-made disasters. All biological agents will be protected from release by multiple structural barriers, filters and sterilization devices. The conceptual design of the facility, which was required for submission of the proposal, was for a strongly constructed, highly engineered building, which, along with strict operating procedures, minimizes the potential for emissions. Moreover, the final design will be subject to further rigorous evaluation by NIH and DOE and other agencies of all aspects of safe operation, including the building's resistance to damage caused by natural disasters or fire. The detailed operations and emergency response plans under which Ricketts will operate will require that hazardous materials be secured during tornado warnings. All areas where biological agents might be stored or used will have highly sensitive smoke and fire detection systems for early warning, as well as fire suppression equipment. All of these systems would be electronically monitored by the Argonne Fire Department, whose members are specially trained for response to hazardous environments, and are available within minutes to respond to even the lowest level of suspected problem. In the event of an emergency, a team of experts will be assembled immediately to coordinate the response, including the necessary evaluation of hazards and notification of the public. Back to Top D16. Will work conducted in this laboratory be secret? Will the community be kept informed about the nature of the research being done? The community will be apprised of research within the bounds of federally-mandated security requirements. No classified work is planned, but restrictions of information could be imposed in the event of a biodefense emergency. Many of the research results of the laboratory would be published in scientific journals and/or shared within the scientific community so the results can be replicated and applied clinically. Summaries of work supported by the National Institutes of Health are publicly available at its website (www.nih.gov). Communication of research results is an ongoing goal for the Ricketts Laboratory. Back to Top Additional Questions E1. Why aren't you planning to build the laboratory closer to the Advanced Photon Source (APS)? While the APS in the southwestern portion of Argonne National Laboratory is very important to infectious disease research, so are other areas of Argonne National Laboratory, including the Bioscience Division laboratories in the northeastern portion of Argonne where complementary research takes place. All Argonne facilities - including APS and other microbiology user facilities being planned - are convenient to the proposed site. Back to Top E2. Will having such a research facility make Argonne and its neighboring communities a more likely target for terrorists? One of the problems with terrorists is that it's impossible to predict what they might do. One of their main goals is to make an impact, and we believe the Ricketts Laboratory would have little value for such intent. Back to Top E3. What provisions will be taken to prevent a terrorist attack on the Ricketts Laboratory that would release dangerous germs into the air or water supply? Terrorist and other malevolent actions/threats are part of ongoing evaluations of all security interests at ANL. Safeguards and Security personnel have been a part of the protection planning process for the Ricketts Laboratory from the earliest stages of development to assure maximum protection. This process is formal and detailed, based on the best classified and unclassified intelligence available. Protection strategies and equipment proposed for the Ricketts Laboratory exceed the established requirements, demonstrating the commitment of the University of Chicago and Argonne National Laboratory to the safety of employees and surrounding communities. However, the Laboratory does not publicly comment on specific security measures for obvious reasons. The amounts of infectious agents in the Ricketts laboratory will be very small, only sufficient to conduct the small-scale research necessary to understand more systematically how pathogens cause disease, and to develop improved strategies for timely identification of approaches for prevention, diagnostics, and treatment in response to changing needs. Back to Top E4. What do the Biosafety levels represent? Biosafety levels have been described in detail in the publication "Biosafety in Microbiological and Biomedical Laboratories", published by U.S. Department of Health and Human Services, Centers for Disease Control and the National Institutes of Health. General descriptions are: Biosafety Level 1 (BSL-1) is suitable for work involving well-characterized agents not known to consistently cause disease in healthy adult humans, and of minimal potential hazard to laboratory personnel and the environment. The laboratory is not necessarily separated from the general traffic patterns in the building. Work is generally conducted on open bench tops using standard microbiological practices. Special containment equipment or facility design are neither required nor generally used. Laboratory personnel have specific training in the procedures conducted in the laboratory and are supervised by a scientist with general training in microbiology or a related science. Biosafety Level 2 (BSL-2) differs from BSL-1 in that (1) laboratory personnel have specific training in handling pathogenic agents and are directed by competent scientists; (2) access to the laboratory is limited when work is being conducted; (3) extreme precautions are taken with contaminated sharp items; and (4) certain procedures in which infectious aerosols or splashes may be created are conducted in biological safety cabinets or other physical containment equipment. Biosafety Level 3 (BSL-3) is applicable to clinical, diagnostic, teaching, research, or production facilities in which work is done with indigenous or exotic agents which may cause serious or potentially lethal disease as a result of exposure by the inhalation route. Laboratory personnel have specific training in handling pathogenic and potentially lethal agents, and are supervised by competent scientists who are experienced in working with these agents. Access to the laboratory is restricted by a combination of methods. All procedures involving the manipulation of infectious materials are conducted within biological safety cabinets or other physical containment devices, and by personnel wearing appropriate personal protective clothing and equipment. The laboratory has special engineering, design and operational features that rigorously assure that all infectious agents stored or in use remain in the laboratory. All waste generated in the laboratory is sterilized before release. The workers' special laboratory clothing remains in the laboratory until it has been properly cleaned or sterilized. Biosafety Level 4 (BSL-4) is required for work with dangerous and exotic agents that pose a high individual risk of aerosol-transmitted laboratory infections and life- threatening disease. Agents with a close or identical antigenic relationship to BSL-4 agents are handled at this level until sufficient data are obtained either to confirm continued work at this level or to work with them at a lower level. Members of the laboratory staff have specific and thorough training in handling extremely hazardous infectious agents and they understand the primary and secondary containment functions of the standard and special practices, the containment equipment, and the laboratory design characteristics. They are supervised by competent scientists who are trained and experienced in working with these agents. Access to the laboratory is strictly controlled by the laboratory director. The facility is either in a separate building or in a controlled area within a building, which is completely isolated from all other areas of the building. A specific facility operations manual is prepared or adopted. Within work areas of the facility, all activities are confined to Class III biological safety cabinets or Class II biological safety cabinets used with one-piece positive pressure personnel suits ventilated by a life support system. The BSL-4 laboratory has special engineering and design features to prevent microorganisms from being disseminated into the environment. For a complete list of requirements, see http://www.cdc.gov/od/ohs/biosfty/bmbl4/bmbl4s3.htm Back to Top E5. You indicated that, as a BSL-3 facility, the Ricketts Laboratory will handle only pathogens for which there are cures or vaccines, but isn't it likely that your manipulation of the known germs may result in mutations for which there is no known treatment? It is highly unlikely that research performed in the Ricketts Laboratory would result in modified bacteria or viruses with increased virulence. In fact, the proposed research programs aim to identify genes and mechanisms involved in pathogenesis by scoring exclusively for reduced virulence of bacteria and viruses. Furthermore, all bacteria and viruses that enter the laboratory, regardless of their potential for causing disease, will be sterilized (killed) before disposal. Back to Top E6. Can you assure the community that the Ricketts Laboratory or any program developed therein will not evolve into a BSL-4 initiative? The lease for the federal land prohibits performing research that requires BSL-4 containment, and even were a change contemplated, it could not be evolutionary. The physical, regulatory and economic obstacles to changing a BSL-3 so it would meet BSL-4 criteria are virtually insurmountable. In recognition of the substantially different design requirements for construction and operation between BSL-3 and BSL-4 facilities, NIAID requested proposals for either one or the other, and allocated substantially different levels of funding for the two types of facilities. Thus, should any change be contemplated, it would require either highly disruptive major renovation or construction of a new facility. This would require new community acceptance, a separate, independent environmental analysis, and a revision of the DOE-approved release. Back to Top E7. Has there ever been an accident involving the public at a BSL-3 or BSL-4 facility? No. A number of BSL-3 and BSL-4 facilities have operated safely in the United States for 30 years. Rare accidents, such as needlesticks, may cause exposure of laboratory staff; immediate treatment of any person so exposed avoids any danger to other workers or to the community. Back to Top E8. Who will conduct the impact study to determine the likely consequences of any release into the atmosphere of the pathogens handled at the Ricketts Center? In accordance with the National Environmental Policy Act (NEPA), the U.S. Department of Health and Human Services and its National Institute of Health, as the federal funding agency for construction, will be the lead agency responsible for necessary environmental evaluations. The Department of Energy (DOE) will cooperate in conducting the evaluations and/or evaluating the results because the facility is to be constructed on land leased from DOE. Professionals from Argonne, who have demonstrated expertise in evaluating potential environmental impacts, including the likelihood and consequences of any significant release, will conduct the evaluations. All aspects of planning for the Ricketts Laboratory are taken with the greatest seriousness, and experience with many other BSL-3 level laboratories leads us to believe that a release most likely will not occur. Back to Top E9. What is the number of fatalities and the number of serious injuries on community residents that are considered tolerable in the cost-to- benefit analysis of this project? No injury or fatality involving the public or employees is acceptable. The federal objective is that the design and operation of the facility, either as proposed or as appropriately modified in accordance with the results of an environmental assessment, can be validly determined to have no significant environmental impact under a variety of normal and adverse conditions. Back to Top E10. What independent entity will be responsible for monitoring compliance with all security measures by the Ricketts Laboratory? Operation of the Ricketts Laboratory may begin only after the federal Center for Disease Control (CDC) completes an on-site audit that concludes that the facility complies with all requirements for physical design and security, and for operating plans such as access control, emergency preparedness and response, and personnel training. The CDC will periodically re-certify the facility; and is authorized to conduct unannounced inspections at any time. As owner of the land, DOE will also monitor compliance. Failure to comply with the regulations can result in substantial civil and criminal penalties. Back to Top E11. What funding or insurance will be secured to care for personal and property losses in case of a release of pathogens or to compensate residents for any devaluation of property values due to proximity to the RBL? The proposed facility is expected to blend seamlessly with Argonne's operations and not create negative effects on property values. The assessment of potential environmental effects of the proposed facility will address this issue in greater detail. On the other hand, creation of high-paying professional jobs has a potential positive effect on property values. Meanwhile, the University maintains insurance programs comparable to those of similar institutions to address any liabilities that might arise from this activity. The analysis continues a process that began in conjunction with the initial design proposals and, since the RBL has been designed to meet or exceed safety and environmental standards for a facility of this sort, it is expected that its construction and operation will have little or no impact on Argonne and its neighbors. Back to Top E12. Have other locations - farther away from populated areas - been considered for this initiative? If so, what locations? The University of Chicago considered a number of locations for the proposed construction of a Biosafety Level 3 laboratory. The Argonne site was chosen because of its proximity to many technical resources unavailable at the campus or anywhere else in the country, its access control/security infrastructure, its emergency preparedness and response resources, and the lack of negative impact on the surrounding communities. Back to Top E13. Will the proposed laboratory be related to the National Nuclear Security Administration? No. The purpose of the Ricketts Laboratory would be to support the work of the National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID), and any public or private entity, so long as their research is compatible with the broad goals established by NIAID. Construction will be funded by the NIH and the University of Chicago with its colleagues.