........ |
September 2007
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), 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-supports
medical research conducted on the NIH campus in Maryland, at the Rocky
Mountain Laboratories in Montana, and 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 has greatly
expanded 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.
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 sufficient research facilities to
carry out these activities
NIAID's strategic plan for biodefense, detailed research agendas, and
progress reports can be found at http://www3.niaid.nih.gov/topics/BiodefenseRelated/Biodefense/about/strategicplan.htm.
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. 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.
The Biosafety in Microbiological and Biomedical Laboratories
guidelines (http://www.cdc.gov/od/ohs/biosfty/bmbl5/bmbl5toc.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.
Georgia State University in Atlanta has a small BSL-3/BSL-4 glove box
facility. In addition, 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.
Recent natural and bioterrorist events involving infectious agents have
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.
BIOSAFETY LAB FACILITY CONSTRUCTION PROJECTS
- NIAID is funding the construction of 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 Integrated Research Facility at Fort Detrick, a U.S.
Army installation located in Frederick, MD
- A new Integrated Research Facility at NIAID's Rocky Mountain Laboratories,
located in Hamilton, MT
- Two National Biocontainment Laboratories (NBLs), located at Boston
University and at the University of Texas Medical Branch at Galveston.
The sites for these NBLs were chosen in a competitive process known
as peer review from among applications received from researchers nationwide.
- NIAID also is funding construction or renovation of facilities
that include BSL-3 and BSL-2 laboratory suites
- The C.W. Bill Young Center for Biodefense and Emerging Infectious
Diseases (Building 33), a new integrated research facility on the
NIH campus in Bethesda, MD, has been completed. For more information
on the Center, see http://www3.niaid.nih.gov/about/organization/dir/building33/.
- Thirteen Regional Biocontainment Laboratories, selected in a competitive,
peer-review process from applications received from researchers nationwide
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 will 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, and 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,
and 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
|
BSL-3 practices plus
- Clothing change before entering
- Shower on exit
- All material decontaminated on exit
from facility
|
- All procedures conducted in Class
III BSCs or Class I or II BSCs in combination with full-body,
air-supplied, positive- pressure personnel suit
|
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"
(bmbl.od.nih.gov/)
|
NIAID is a component of the National Institutes of Health. NIAID
supports basic and applied research to prevent, diagnose and treat infectious
diseases such as HIV/AIDS and other sexually transmitted infections,
influenza, tuberculosis, malaria and illness from potential agents of
bioterrorism. NIAID also supports research on basic immunology, transplantation
and immune-related disorders, including autoimmune diseases, asthma
and allergies.
The National Institutes of Health (NIH)-The Nation's Medical
Research Agency-includes 27 Institutes and Centers and is a component
of the U. S. Department of Health and Human Services. It is the primary
federal agency for conducting and supporting basic, clinical and translational
medical research, and it investigates the causes, treatments and cures
for both common and rare diseases. For more information about NIH and
its programs, visit http://www.nih.gov.
Publications
Home | Search
Last Updated September 26, 2007(alt)
|