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					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.

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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.

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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.

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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.

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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.

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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.)

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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.

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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.

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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.

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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.

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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.
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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.

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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.

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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.

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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.

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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.
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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

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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.

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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.
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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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D7. Would workers at the laboratory be vaccinated?

Yes, where appropriate.

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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.

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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.

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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.

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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.

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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)

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.
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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.

				
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