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February 2004
The Need for Biosafety Laboratory Facilities
Introduction
In the past century, medical research has led to improved health and
increased life expectancy largely because of success in preventing and
treating infectious diseases. This success has come about through the
use of antibiotics and vaccines, improved hygiene, and increased public
awareness. New threats to health continually emerge naturally, however,
as bacteria and viruses evolve, are transported to new environments,
or develop resistance to drugs and vaccines. Some familiar examples
of these so-called emerging or re-emerging infections include HIV/AIDS,
West Nile virus, severe acute respiratory syndrome (SARS), monkeypox,
and annual outbreaks of influenza.
To control epidemics and protect the public health, medical researchers
must quickly identify naturally occurring microbes and then develop
diagnostic tests, treatments, and vaccines for them. Preparing for bioterrorism-the
deliberate release of a microbe into a community in which it is not
a current health concern-calls for the identical scientific skills and
strategies.
For more than 50 years, the National Institute of Allergy and Infectious
Diseases (NIAID), part of the National Institutes of Health (NIH), has
led the nation's medical research effort to understand, treat, and prevent
the myriad infectious diseases that threaten hundreds of millions of
people worldwide. NIAID's portion of the NIH budget-received each year
from Congress-not only supports medical research conducted on the NIH
campus in Maryland but also at universities and research centers primarily
nationwide but also overseas. The benefits of this research reach people
of all ages worldwide.
Because NIAID has broad experience, expertise, and success in developing
medical tools to fight infectious diseases, it now also plays a leading
role in the nation's fight against bioterrorism. The Institute is expanding
its research programs to accelerate the development of new and improved
diagnostics, treatments, and vaccines to protect civilians from deadly
infectious diseases, whether they emerge naturally or are deliberately
released in a bioterrorist attack.
NIAID'S BIODEFENSE RESEARCH PLAN
Through a process of extensive expert consultation, NIAID has developed
a strategic plan for biodefense and emerging infectious diseases research.
Key elements of the plan include the following:
- Support medical research on microbes and the human immune response
to them
- Apply such research to the discovery and development of vaccines,
drugs, and diagnostic tests designed to protect the general population
- Ensure that the United States has enough research facilities to
carry out these activities
NIAID's strategic plan for biodefense, detailed research agendas, and
a progress report can be found at http://biodefense.niaid.nih.gov.
ENSURING SUFFICIENT RESEARCH FACILITIES
NIAID's ultimate goal is to develop new and improved diagnostics, vaccines,
and treatments for diseases caused by infectious agents. Medical tools
such as these can only be developed, however, with a solid understanding
of the biology of the disease-causing agents, whether they occur naturally
or are deliberately released by terrorists. Such research sometimes
requires working with the actual microbes or their toxins. This research
must be conducted in special biosafety laboratories and in accord with
the many laws, regulations, policies, and well-established guidelines
that govern research on these microbes and the design, management, and
operation of these laboratories. All these provisions aim to protect
not only the lab workers but also the surrounding community from accidental
exposure to infectious agents.
Certain guidelines (Biosafety in Microbiological and Biomedical
Laboratories, http://bmbl.od.nih.gov/index.htm)
specify four levels of safety and security required for laboratory facilities
in which such research will take place. The general characteristics
of the biosafety levels (often referred to as BSL-2 to BSL-4) are summarized
in Table 1.
Many U.S. institutions and companies with infectious disease research
programs have BSL-3 laboratory suites required to perform their research.
Most such laboratories, however, are small, dedicated to particular
uses, or in need of modernization. In addition, some hospitals have
small laboratory or clinical areas that can operate at this level, including
space for isolating patients suspected or known to have certain highly
contagious diseases.
BSL-4 labs have the most stringent safety and security requirements.
There are currently only four operational BSL-4 laboratory suites in
the United States: at the Centers for Disease Control and Prevention
in Atlanta; at the United States Army Medical Research Institute for
Infectious Diseases at Fort Detrick in Frederick, MD; at the Southwest
Foundation for Biomedical Research in San Antonio; and at the University
of Texas at Galveston. A small BSL-4 facility exists on the NIH campus
in Bethesda, MD, but it is currently being operated only at a BSL-3
level for research on important emerging infectious diseases.
The recent bioterrorist events made it very clear that from a strategic
national perspective, a serious shortage of BSL-3 and BSL-4 laboratory
space exists. This problem has been well documented by the Institute
of Medicine, and it has repeatedly been identified in NIAID's strategic
planning process. Thus, NIAID's research agenda for biodefense and emerging
infectious diseases includes plans to construct and renovate BSL-3 and
BSL-4 laboratories around the country. To be most effective, these laboratories
must be located where established teams of researchers already work
side-by-side on related scientific problems.
PROPOSED BIOSAFETY LAB FACILITIES
- NIAID has received funding to construct four new national
facilities, all of which will include BSL-4 and BSL-3 laboratory suites
as well as BSL-2 space
- A new NIAID facility at Fort Detrick, a U.S. Army installation
located in Frederick, MD
- A new facility at NIAID's Rocky Mountain Laboratories, located
in Hamilton, MT
- Two National Biocontainment Laboratories, located at Boston
University and at the University of Texas Medical Branch at Galveston.
The sites for these were chosen in a competitive process known
as peer review from among applications received from researchers
nationwide
Additional individual information on all these projects can be
found at these links
http://www.niaid.nih.gov/biodefense/public/detrick_rocky_qa.htm
http://www.niaid.nih.gov/newsroom/releases/nblscorrect21.htm
- NIAID also is funding construction or renovation of facilities
that include BSL-3 and BSL-2 laboratory suites
- Building 33, a new integrated research facility, on the NIH
campus in Bethesda, MD
- Nine Regional Biocontainment Laboratories, selected in a competitive,
peer-review process from applications received from researchers
nationwide
Additional individual information on all these projects can be
found at these links
http://www.niaid.nih.gov/factsheets/qanda.htm
http://www.nih.gov/news/NIH-Record/10_14_2003/story01.htm
http://www.niaid.nih.gov/newsroom/releases/nblscorrect21.htm
FEATURES OF RESEARCH PLANNED FOR THESE FACILITIES
NIAID-Funded Research Will Include
- Laboratory research on the biology of the disease-causing agents
- Laboratory and animal model studies testing the usefulness of new
drugs, vaccines, and diagnostic tests to detect, treat, and prevent
illness among civilians
- Adherence to all relevant security and safety standards required
by law
NIAID-Funded Research Will NOT Include
- Research on bioweapons (which is not even permissible under international
law)
NIAID Policies Regarding Security, Publication, and Secrecy
- The extent to which publications or access to data from biodefense
research should be limited is being widely debated. NIAID supports
a policy encouraging publication and dissemination of research findings
through proper scientific channels in the belief that this policy
will provide many more opportunities for good than for harm. More
people will know more about microbes and toxins and be able to use
that information for beneficial purposes. The fact that the information
is widely available in the scientific community makes it less attractive
to use with malicious intent.
- NIAID is not supporting any secret (so-called "classified") research.
Furthermore, NIAID has no plans to do so. This matter is also being
widely debated among scientists and policy makers, and it is possible
that in the future, the criteria for what should and should not be
classified might change. Nonetheless, NIAID supports a policy of openness.
The justification for classifying certain projects would require a
clear case that the potential for harm from misuse of specific information
by individuals with nefarious intents significantly exceeds the potential
for good. Whether it is classified or not, however, it is important
to emphasize that NIAID-funded research will not include research
on bioweapons.
Table 1: Biosafety Levels
Biosafety Level |
Agents |
Practices |
Safety Equipment |
Facilities |
BSL-1 |
These agents are not generally associated with disease
in healthy people |
- Good microbiological practice
- Hand washing
- No eating, drinking or gum chewing in the laboratory
|
- Pipeting devices- mouth pipeting is prohibited
|
|
BSL-2 |
These agents are associated with human disease |
- Limited lab access
- Most work may be performed on a bench top
- Biohazard warning signs
- "Sharps" precautions
- Biosafety manual defining any needed waste decontamination
or medical surveillance policies
|
- Class I or II Biological Safety Cabinets (BSCs) or other physical
containment devices
- Lab coats, gloves, face protection, as needed
|
- Open bench-top
- sink for hand washing is required
- Autoclave available
|
BSL-3 |
These agents:
- Are associated with human disease and cause illness by spreading
through the air (aerosol)
- Cause diseases that may have serious or lethal consequences
|
BSL-2 practice plus
- Controlled access
- Decontamination of all waste
- Decontamination of lab clothing before laundering
|
- Class I or II Biological Safety Cabinets (BSCs) or other physical
containment devices
- Protective lab clothing, gloves, respiratory protection as
needed
|
BSL-2 plus
- Physical separation from access corridors
- Self-closing, double-door access
- Exhaust air is not recirculated
- Negative airflow into laboratory
- Design includes back-up/redundant systems
|
BSL-4 |
These agents:
- Are associated with human disease and cause illness by spreading
through the air (aerosol) or have an unknown cause of transmission;
- Cause diseases that are usually life-threatening;
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BSL-3 practices plus
- Clothing change before entering
- Shower on exit
- All material decontaminated on exit from facility
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- All procedures conducted in Class III BSCs or Class I or II
BSCs in combination with full-body, air-supplied, positive-
pressure personnel suit
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BSL-3 plus - Separate building or isolated
zone
- Dedicated supply and exhaust, vacuum, and decontamination systems
- Design includes back-up/redundant systems
- Other requirements outlined in NIH/CDC publication "Biosafety
in Microbiological and Biomedical Laboratories"*
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NIAID is a component of the National Institutes of Health
(NIH), which is an agency of the Department of Health and Human Services.
NIAID supports basic and applied research to prevent, diagnose, and
treat infectious and immune-mediated illnesses, including HIV/AIDS
and other sexually transmitted diseases, illness from potential agents
of bioterrorism, tuberculosis, malaria, autoimmune disorders, asthma
and allergies.
News releases, fact sheets and other NIAID-related
materials are available on the NIAID Web site at http://www.niaid.nih.gov.
Prepared by:
Office of Communications and Public Liaison
National Institute of Allergy and Infectious Diseases
National Institutes of Health
Bethesda, MD 20892
U.S. Department of Health and Human Services
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Last Updated April 30, 2004 (alt)
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